SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are incorporated by reference herein and therein contain “forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words “expect,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or forward-looking nature identify forward-looking statements for purposes of the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differ.
Appears in 2 contracts
Samples: At Market Issuance Sales Agreement, At Market Issuance Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and Some of the accompanying base prospectus and the documents we file with the SEC that are statements contained or incorporated by reference herein and therein contain “in this prospectus may include forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements that reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words “expect,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or forward-looking nature identify forward-looking statements for purposes of the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management We undertake no obligation to predict all risks, nor can we assess the impact of all factors on our business publicly update or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in review any forward-looking statements we may make. Given these uncertaintiesstatement, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate whether as a result of any date other than the date on the front of this prospectus supplementnew information, future developments or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statementsotherwise. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stockour securities, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differ.
Appears in 2 contracts
Samples: At Market Issuance Sales Agreement, At Market Issuance Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are incorporated applicable prospectus supplement include and incorporate by reference herein and therein contain “"forward-looking statements” within ." We intend these forward- looking statements to be covered by the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include safe harbor provisions for forward-looking statements both with respect to us, specifically, and the biotechnology sector, contained in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words “Words such as "anticipate," "estimate," "expect,” “" "project," "intend,” “" "may," "plan,” “" "predict," "believe,” “project,” “estimate,” “may,” “" "should,” “anticipate,” “will” " and similar statements of a future words or forward-looking nature expressions are intended to identify forward-looking statements, although not all forward-looking statements for purposes contain these identifying words. These forward-looking statements include any statements, other than statements of the federal securities laws historical facts, included or otherwiseincorporated in this prospectus regarding our strategy, future operations, financial position, future revenues, projected costs, prospects, plans and objectives of management. All forward-looking statements involve inherent risks reflect the present expectation of future events of our management and uncertaintiesare subject to known and unknown risks, uncertainties and there are or will be important factors assumptions that could cause actual results to differ materially from those indicated described in these any forward-looking statements. We believe that these factors These risks and uncertainties include, but among others, changes in and uncertainty of customer acceptance of and demand for our existing products and technologies and products and technologies under development; risks associated with the concentration of product sales among a limited number of customers; the success of product, licensing and joint development partnerships; continuing development, qualification and volume production of HybriDIMM™, EXPRESSvault™, NVvault™, HyperCloud® and VLP Planar-X RDIMM; the timing and magnitude of any continued decrease in our sales; our ability to leverage our NVvault™ and EXPRESSvault™ technology into a more diverse customer base; our need to raise additional capital and our ability to obtain financing when necessary; the rapidly-changing nature of technology in our industry; risks associated with intellectual property, including patent infringement litigation against us as well as the costs and unpredictability of litigation over infringement of our intellectual property and the possibility of our patents being reexamined or reviewed by the U.S. Patent and Trademark Office and Patent Trial and Appeal Board; volatility in the pricing of components of our products; changes in and uncertainty of customer acceptance of, and demand for, our existing products and products under development, including uncertainty of and/or delays in product orders and product qualifications; delays in our and our customers' product releases and development; introductions of new products by competitors; changes in end-user demand for technology solutions; our ability to attract and retain skilled personnel; our reliance on suppliers of critical components and vendors in the supply chain; fluctuations in the market price of critical components; evolving industry standards; the political and regulatory environment in the PRC; and general economic and market conditions. Other risks and uncertainties are not limited to, those factors set forth described in greater detail under the caption “heading "Risk Factors” " contained in this the applicable prospectus supplement and in the accompanying base prospectus any related free writing prospectus, and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report annual report on Form 10-K and in our subsequent Quarterly Reports most recent quarterly report on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements as well as any amendments thereto reflected in light of those risks as you read this prospectus supplement and subsequent filings with the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may makeSEC. Given these uncertaintiesrisks, uncertainties and other important factors, you should not place undue reliance on these forward- forward-looking statements. You should not assume that carefully read both this prospectus, the applicable prospectus supplement and any related free writing prospectus, together with the information contained in this prospectus supplement is accurate incorporated herein by reference as described under the headings "Incorporation of Certain Documents by Reference" and "Where You Can Find Additional Information," completely and with the understanding that our actual future results may be materially different from what we expect. These forward-looking statements represent our estimates and assumptions only as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by referencemade. Except as required by law, we assume We undertake no obligation duty to update these forward-looking statements publiclyafter the date of this prospectus, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statementsexcept as required by law, even if new information becomes available though our situation may change in the future. Thus, you should not assume that We qualify all of our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differthese cautionary statements.
Appears in 1 contract
Samples: At Market Issuance Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the financial statements and other documents we file with the SEC that are incorporated by reference herein and therein in this prospectus contain “forward-looking statements” , including statements concerning our industry, our operations, our anticipated financial performance and financial condition, and our business plans and growth strategy and product development efforts. These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include Many of the forward-looking statements both with respect to us, specifically, and contained in this prospectus can be identified by the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions use of the Private Securities Litigation Reform Act of 1995. Statements that include the forward-looking words such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “plan,” “believetarget,” “project,” “estimate,” “maybelieve,” “shouldpredict,” “anticipate,potential” or “willcontinue” and similar statements of a future or among others. Readers are cautioned not to place undue reliance on these forward-looking nature identify statements, which speak only as of their dates. These forward-looking statements for purposes are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain and subject to a number of the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties. The following represent some, and there are or will be important but not necessarily all, of the factors that could cause actual results to differ materially from historical results or those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider anticipated or predicted by our forward-looking statements: • the timing, progress and results of clinical trials of IFX-1 and any other product candidates, including statements in light regarding the timing of those risks as you read this prospectus supplement initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, the costs of such trials and our research and development programs generally; • the timing and outcome of any discussions or submission of filings for regulatory approval of IFX-1 or any other product candidate, and the accompanying base prospectus. It is not possible timing of and our ability to obtain and maintain regulatory approval of IFX- 1 for any indication; • our ability to leverage our proprietary anti-C5a technology to discover and develop therapies to treat complement-mediated autoimmune and inflammatory diseases; • our ability to protect, maintain and enforce our intellectual property protection for IFX-1 and any other product candidates, and the scope of such protection; • whether the Food and Drug Administration, European Medicines Agency or comparable foreign regulatory authority will accept or agree with the number, design, size, conduct or implementation of our clinical trials, including any proposed primary or secondary endpoints for such trials; • the success of our future clinical trials for IFX-1 and any other product candidates and whether such clinical results will reflect results seen in previously conducted preclinical studies and clinical trials; • our expectations regarding the size of the patient populations for, market opportunity for and clinical utility of IFX-1 or any other product candidates, if approved for commercial use; • our manufacturing capabilities and strategy, including the scalability and cost of our manufacturing methods and processes and the optimization of our manufacturing methods and processes, and our ability to continue to rely on our existing third-party manufacturers for our management planned future clinical trials; • our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to predict all risksobtain additional financing; • our expectations regarding the scope of any approved indication for IFX-1; • our ability to defend against costly and damaging liability claims resulting from the testing of our product candidates in the clinic or, nor can we assess the impact if, approved, any commercial sales; • our ability to commercialize IFX-1 or our other product candidates; • if any of all factors our product candidates obtain regulatory approval, our ability to comply with and satisfy ongoing obligations and continued regulatory overview; • our ability to comply with enacted and future legislation in seeking marketing approval and commercialization; • our future growth and ability to compete, which depends on our business retaining key personnel and recruiting additional qualified personnel; • our competitive position and the development of and projections relating to our competitors in the development of C5a inhibitors or our industry; • our expectations regarding the extent to time during which any factorwe will be an emerging growth company under the JOBS Act or a foreign private issuer; • the recent outbreak of the COVID-19, or combination of factors, which may cause business disruptions and could adversely impact our business, including our supply chain, clinical trials and commercialization of our product candidates; and • other risk factors discussed under “Risk Factors.” Our actual results to or performance could differ materially from those contained in expressed in, or implied by, any forward- looking statements relating to those matters. Accordingly, no assurances can be given that any of the events anticipated by the forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplementwill transpire or occur, or that if any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date them do so, what impact they will have on our results of the document so incorporated by referenceoperations, cash flows or financial condition. Except as required by law, we assume are under no obligation obligation, and expressly disclaim any obligation, to update these update, alter or otherwise revise any forward-looking statements publiclystatement, whether written or oral, that may be made from time to update the reasons actual results could differ materially from those anticipated in these forward-looking statementstime, even if whether as a result of new information becomes available in the future. Thusinformation, you should not assume that our silence over time means that actual future events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differotherwise.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are incorporated by reference herein and therein contain “contains forward-looking statements” statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (amended, or the “Exchange Act”). All statements, these other than statements reflect of historical fact, included or incorporated in this report regarding our current views with respect to our ongoing and planned clinical trials, business strategy, business planfuture operations, collaborations, intellectual property, cash resources, financial performance position, future revenues, projected costs, prospects, plans, and other future events. These statements include objectives of management are forward-looking statements both with respect to us, specifically, and the biotechnology sector, in generalstatements. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the The words “expectbelieves,” “intendanticipates,” “planestimates,” “believeplans,” “projectexpects,” “estimateintends,” “may,” “could,” “should,” “anticipatepotential,” “likely,” “projects,” “continue,” “will,” and “would” and similar statements of a future or forward-looking nature expressions are intended to identify forward-looking statements for purposes of the federal securities laws or otherwise. All statements, although not all forward-looking statements involve inherent risks contain these identifying words. We cannot guarantee that we actually will achieve the plans, intentions or expectations disclosed in our forward-looking statements and uncertainties, and there you should not place undue reliance on our forward-looking statements. There are or will be a number of important factors that could cause our actual results to differ materially from those indicated in these or implied by forward-looking statements. We believe that these These important factors include, but are not limited to, include those factors set forth below under the caption heading “Risk Factors.” These factors and the other cautionary statements made in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, should be read as being applicable to all of which you should review carefully. Please consider our related forward-looking statements whenever they appear in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risksIn addition, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertaintiesrepresent our estimates only as of the date that this prospectus is filed with the SEC, you and should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate be relied upon as representing our estimates as of any date other than the date on the front of this prospectus supplement, or that subsequent date. We do not assume any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such any forward-looking statements. If one We disclaim any intention or more of these obligation to update or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral revise any forward-looking statements attributable to us statement, whether as a result of new information, future events or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differotherwise.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and supplement, the documents we file with the SEC that are incorporated by reference herein and therein any accompanying prospectus may contain “or incorporate forward-looking statements that are based on our management□s belief and assumptions and on information currently available to our management. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements stated in or implied by these forward-looking statements” within . All statements other than statements of historical facts are forward-looking statements. These forward-looking statements are made under the meaning of □safe harbor□ provision under Section 27A of the Securities Act, Act and Section 21E of the Securities Exchange Act of 1934, and as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology sector, defined in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words “expect,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or forward-looking nature In some cases, you can identify forward-looking statements for purposes by terminology such as □may,□ □will,□ □should,□ □expects,□ □intends,□ □plans,□ □anticipates,□ □believes,□ □estimates,□ □predicts,□ □potential,□ □continue□ or the negative of the federal securities laws these terms or otherwiseother comparable terminology. All forward-These statements are only predictions. You should not place undue reliance on forward- looking statements because they involve inherent risks known and uncertaintiesunknown risks, uncertainties and other factors, which are, in some cases, beyond our control and which could materially affect results. You should refer to the □Risk Factors□ section of this prospectus supplement, the accompanying prospectus, and there are or will be important factors our periodic and current reports filed with the SEC for specific risks that could cause actual results to differ materially be significantly different from those indicated stated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such by these forward-looking statements. If one or more of these or other risks or uncertainties materializesoccur, or if our underlying assumptions prove to be incorrect, actual events or results may vary materially significantly from what we anticipate. All subsequent written and oral those implied or projected by the forward-looking statements. No forward-looking statement is a guarantee of future performance. Forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all speak only as of the factors set forth date made and we undertake no obligation to publicly update or referred to revise any forward- looking statements, whether as a result of new information, future events or otherwise. You should read this prospectus, any accompanying prospectus and the documents that we reference in this prospectus supplement and have filed with the SEC as exhibits to the registration statement, of which this prospectus supplement is a part, completely and with the understanding that our actual future results may be materially different from any future results stated in or implied by these forward-looking statements. Forward-looking statements in this prospectus supplement include, but are not limited to, statements about: ■ the initiation, timing, progress and results of our studies in animals and clinical trials, and our research and development programs; ■ our ability to advance our product candidates into, and successfully complete, clinical trials; ■ our reliance on the success of our clinical-stage product candidates; ■ the timing or likelihood of regulatory filings and approvals; ■ the commercialization of our product candidates, if approved; ■ our ability to develop sales and marketing capabilities; ■ the pricing and reimbursement of our product candidates, if approved; ■ the implementation of our business model, strategic plans for our business and technology; ■ the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; ■ our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; ■ costs associated with defending intellectual property infringement, product liability and other claims; ■ regulatory development in the United States, China and other jurisdictions; ■ estimates of our expenses, future revenues, capital requirements and our needs for additional financing; ■ the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements; ■ our ability to maintain and establish collaborations or obtain additional grant funding; ■ the rate and degree of market acceptance of our product candidates; ■ developments relating to our competitors and our industry, including competing therapies; ■ our ability to effectively manage our anticipated growth; ■ our ability to attract and retain qualified employees and key personnel; ■ our expectations regarding the period during which we qualify as an emerging growth company under the U.S. Jumpstart Our Business Startups Act, or the JOBS Act; ■ statements regarding future revenue, hiring plans, expenses, capital expenditures, capital requirements and share performance; ■ the future trading price of our ordinary shares and impact of securities analysts’ reports on these prices; ■ our ability to continue as a going concern; ■ the use of proceeds from this offering; and ■ other risks and uncertainties, including those listed under the caption □Risk Factors□ in this prospectus supplement, the accompanying base prospectus that could cause actual results and our Annual Report on Form 20-F. The □Risk Factors□ section of this prospectus supplement, the accompanying prospectus and our Annual Report on Form 20-F references the principal contingencies and uncertainties to differwhich we believe we are subject, which should be considered in evaluating any forward-looking statements contained or incorporated by reference in this prospectus supplement and the accompanying prospectus.
Appears in 1 contract
Samples: Open Market Sale Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are incorporated by reference herein and therein contain “contains forward-looking statements” statements within the meaning of Section 27A of the Securities ActAct of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)amended, these which statements reflect involve substantial risks and uncertainties. Forward-looking statements generally relate to future events or our current views with respect to our ongoing and planned clinical trialsfuture financial or operating performance. In some cases, business strategy, business plan, financial performance and other future events. These statements include you can identify forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the because they contain words such as “expectmay,” “intend,” “plan,” “believe,” “project,” “estimate,” “maywill,” “should,” “anticipateexpects,” “willplans,” and “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these words or other similar statements of a future terms or forward-looking nature identify forwardexpressions that concern our expectations, strategy, plans or intentions. Forward-looking statements for purposes of contained in this prospectus supplement, the federal securities laws or otherwise. All forward-looking statements involve inherent risks accompanying prospectus and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated the documents incorporated by reference in these statements. We believe that these factors this prospectus supplement include, but are not limited to, those factors set forth under statements about: 🞎 how long we expect to maintain liquidity to fund our planned level of operations and our ability to obtain additional funds for our operations; 🞎 the caption “Risk Factors” development of our drug and vaccine candidates, including when we expect to undertake, initiate and complete clinical trials of our drug and vaccine candidates; 🞎 the expectation, plans, projections, initiation, timing, progress and results of our research and development programs, preclinical studies, any clinical trials, compassionate uses, IND, filings, Clinical Trial Application, or CTA, filings, New Drug Application, or NDA, filings, and other regulatory submissions; 🞎 regulatory developments involving products, including the ability to obtain regulatory approvals or otherwise bring products to market; 🞎 the regulatory status of our drug and vaccine candidates, including our ability to obtain and maintain orphan drug, rare pediatric and RMAT designations for our lead product candidate, CAP-1002; 🞎 our use of clinical research centers, third party manufacturers and other contractors; 🞎 our ability to find collaborative partners for research, development and commercialization of potential products and retain commercial rights for our product candidates in the collaborations; 🞎 our ability to manufacture products for clinical and commercial use; 🞎 our ability to protect our patents and other intellectual property; 🞎 the potential impact of COVID-19 on our business, including our ability to conduct clinical trials and further product candidate development; 🞎 our ability to raise additional financing and the terms of any additional financing; 🞎 our ability to market any of our products; 🞎 the implementation of our business model and strategic plans for our business, technologies and product candidates; 🞎 our estimates of our expenses, ongoing losses, future revenue and capital requirements; 🞎 the impact of taxes on our business; 🞎 our ability to compete against other companies and research institutions; 🞎 our ability to expand our operations internationally; 🞎 the effect of potential strategic transactions on our business; 🞎 acceptance of our products by doctors, patients or payors and the availability of reimbursement for our product candidates; 🞎 our ability to attract and retain key personnel; and 🞎 the volatility of our stock price. We caution you that the forward-looking statements highlighted above do not encompass all of the forward-looking statements made in this prospectus supplement. You should not rely upon forward-looking statements as predictions of future events. We have based the forward-looking statements contained in this prospectus supplement primarily on our current expectations and projections about future events and trends that we believe may affect our business, financial condition, results of operations and prospects. The outcome of the events described in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our these forward-looking statements is subject to risks, uncertainties and other factors. Moreover, we operate in light of those a very competitive and challenging environment. New risks as you read this prospectus supplement and the accompanying base prospectus. It uncertainties emerge from time to time, and it is not possible for our management us to predict all risksrisks and uncertainties that could have an impact on the forward-looking statements contained in this prospectus supplement. We cannot assure you that the results, nor can we assess events and circumstances reflected in the impact of all factors on our business forward-looking statements will be achieved or the extent to which any factoroccur, and actual results, events or combination of factors, may cause actual results to circumstances could differ materially from those contained described in the forward-looking statements. Additionally, final data may differ significantly from preliminary data reported in this prospectus supplement. The forward-looking statements made in this prospectus supplement relate only to events as of the date on which the statements are made. We undertake no obligation to update any forward-looking statements we made in this prospectus supplement to reflect events or circumstances after the date of this prospectus supplement or to reflect new information or the occurrence of unanticipated events, except as required by law. We may make. Given these uncertaintiesnot actually achieve the plans, intentions or expectations disclosed in our forward- looking statements and you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral Our forward-looking statements attributable to us do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or individuals acting investments we may make, if any. This prospectus supplement also contains statistical data, estimates and forecasts that are based on independent industry publications or other publicly available information, as well as other information based on our behalf are expressly qualified in their entirety by this Noteinternal sources. Before purchasing any shares of common stock, you should consider carefully all of Although we believe that the factors set forth or third-party sources referred to in this prospectus supplement are reliable, we have not independently verified the information provided by these third parties. While we are not aware of any misstatements regarding any third-party information presented in this prospectus supplement, their estimates, in particular, as they relate to projections, involve numerous assumptions, are subject to risks and uncertainties, and are subject to change based on various factors. We may issue and sell up to an aggregate amount of $75,000,000 worth of our common stock from time to time through Xxxxxxxxxx, acting as agent. The amount of proceeds we will receive from this offering, if any, will depend upon the actual number of shares of our common stock sold and the market price at which such shares are sold. There can be no assurance that we will be able to sell any shares in this offering. Because there is no minimum offering amount required as a condition to close this offering, the net proceeds to us, if any, are not determinable at this time. We currently intend to use the net proceeds from this offering, if any, for research and development related to our product candidates, manufacturing of our products, working capital and general corporate purposes. The amounts and timing of our use of the net proceeds from this offering will depend on a number of factors, such as the timing and progress of our research and development efforts, the timing and progress of any partnering and commercialization efforts, technological advances and the competitive environment for our products. As of the date of this prospectus supplement, we cannot specify with certainty all of the particular uses for the net proceeds to us from this offering. Accordingly, our management will have broad discretion in the accompanying base prospectus timing and application of these proceeds. We reserve the right, at the sole discretion of our Board of Directors, to reallocate the proceeds of this offering in response to developments in our business and any other factors. If you invest in this offering, your ownership interest will be diluted to the extent of the difference between the public offering price per share and the as adjusted net tangible book value per share of our common stock after giving effect to this offering. represents total tangible assets less total liabilities, divided by the number of shares of common stock outstanding at March 31, 2021. After giving effect to the assumed sale of our common stock in the aggregate of $75,000,000 offered at an assumed offering price of $4.53 per share, the last reported sales price for our common stock on June 15, 2021, and after deduction of commissions and estimated offering expenses payable by us, our as adjusted net tangible book value as of March 31, 2021 would have been approximately $109.1 million, or $2.77 per share of common stock. This amount represents an immediate increase in as adjusted net tangible book value of approximately $1.18 per share to our existing stockholders and an immediate dilution in the as adjusted net tangible book value of approximately $1.76 per share to investors participating in this offering at an assumed offering price of $4.53 per share. Dilution per share to new investors is determined by subtracting the as adjusted net tangible book value per share after this offering from the public offering price per share paid by purchasers in this offering. The following table illustrates this dilution on a per share basis: Assumed offering price per share $ 4.53 Net tangible book value per share as of March 31, 2021 $ 1.60 Increase in as adjusted net tangible book value per share attributable to this offering 1.18 As adjusted net tangible book value per share after this offering 2.77 Dilution per share to new investors participating in this offering $ 1.76 The table above assumes for illustrative purposes that could cause actual results an aggregate of 16,556,291 shares of our common stock are sold in this offering at a price of $4.53 per share, the last reported sales price for our common stock on The Nasdaq Capital Market on June 15, 2021, for aggregate gross proceeds of approximately $75.0 million. Pursuant to differthe Sales Agreement with Xxxxxxxxxx, the shares being sold in this offering are being sold from time to time at various prices. An increase of $1.00 per share in the price at which the shares are sold from the assumed offering price of $4.53 per share shown in the table above, assuming all of our common stock in the aggregate amount of $75,000,000 are sold at that price in this offering, would increase our pro forma net tangible book value per share after the offering to $3.00 per share and would increase the dilution in net tangible book value per share to new investors in this offering to $2.53 per share, after deducting commissions and estimated aggregate offering expenses payable by us. A decrease of $1.00 per share in the price at which the shares are sold from the assumed offering price of $4.53 per share shown in the table above, assuming all of our common stock in the aggregate amount of $75,000,000 are sold at that price in this offering, would decrease our pro forma net tangible book value per share after the offering to $2.48 per share and would decrease the dilution in net tangible book value per share to new investors in this offering to $1.05 per share, after deducting commissions and estimated aggregate offering expenses payable by us. This information is supplied for illustrative purposes only. The amounts above are based on 22,797,930 shares of common stock outstanding as of March 31, 2021 and do not take into account, as of March 31, 2021: 🞎 126,173 shares of common stock issuable upon the exercise of warrants outstanding as of March 31, 2021 with a weighted-average exercise price of approximately $1.32 per share; 🞎 3,667,064 shares of common stock issuable upon the exercise of options outstanding as of March 31, 2021 with a weighted-average exercise price of approximately $2.54 per share; and 🞎 25,500 shares of common stock issuable upon the exercise of options granted subsequent to March 31, 2021 with a weighted-average exercise price of approximately $4.37 per share; 🞎 515,647 shares of common stock reserved as of March 31, 2021 for future issuance under our (1) 2020 Equity Incentive Plan; (2) 2012 Restated Equity Incentive Plan; and (3) 2012 Non-Employee Director Stock Option Plan; and 🞎 3,500,000 additional shares of common stock reserved as of June 11, 2021 for future issuance under our 2021 Equity Incentive Plan.
Appears in 1 contract
Samples: Common Stock Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and supplement, the accompanying base prospectus and the documents we file with the SEC that are incorporated by reference herein and therein contain “forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-forward- looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words “Forward-looking statements represent our management's judgment regarding future events. In many cases, you can identify forward- looking statements by terminology such as "may," "will," "should," "plan," "expect,” “" "anticipate," "estimate," "predict," "intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and " "potential" or "continue" or the negative of these terms or other words of similar statements of a future or forward-looking nature identify import, although some forward-looking statements for purposes of the federal securities laws or otherwiseare expressed differently. All statements other than statements of historical fact included in this prospectus supplement, the accompanying prospectus and the documents incorporated by reference herein regarding our financial position, business strategy and plans or objectives for future operations are forward-looking statements. We cannot guarantee the accuracy of forward-looking statements, and you should be aware that results and events could differ materially and adversely from those described in the forward-looking statements involve inherent risks and uncertainties, and there due to a number of factors. There are or will be a number of important factors that could cause the actual results to differ materially from those indicated expressed in these statementsany forward- looking statement made by us. We believe that these These factors include, but are not limited to: • our ability to achieve profitability by increasing sales of our laboratory tests and services and to continually develop and commercialize novel and innovative genomic-based diagnostic tests and services for cancer patients; • our ability to raise additional capital to meet our liquidity needs; • our ability to clinically validate our pipeline of genomic microarray tests currently in development; • our ability to execute on our marketing and sales strategy for our genomic tests and gain acceptance of our tests in the market; • our ability to keep pace with rapidly advancing market and scientific developments; • our ability to satisfy U.S. (including FDA) and international regulatory requirements with respect to our tests and services, those factors many of which are new and still evolving; • our ability to obtain reimbursement from governmental and other third-party payors for our tests and services; • competition from clinical laboratory services companies, genomic-based diagnostic tests currently available or new tests that may emerge; • our ability to maintain our clinical collaborations and enter into new collaboration agreements with highly regarded organizations in the cancer field so that, among other things, we have access to thought leaders in the field and to a robust number of samples to validate our genomic tests; • our ability to maintain our present customer base and obtain new customers; • potential product liability or intellectual property infringement claims; • our dependency on third-party manufacturers to supply or manufacture our products; • our ability to manage significant fluctuations in our quarterly operating results, which may occur as a result of the timing, size and duration of our contracts with biopharmaceutical companies and clinical research organizations; • our ability to attract and retain a sufficient number of scientists, clinicians, sales personnel and other key personnel with extensive experience in oncology, who are in short supply; • our ability to obtain or maintain patents or other appropriate protection for the intellectual property in our proprietary tests and services; • our dependency on the intellectual property licensed to us or possessed by third parties; • our ability to expand internationally and launch our tests in emerging markets, such as India and Brazil; and • our ability to adequately support future growth. You should also consider carefully the statements set forth under in the caption “section titled "Risk Factors” " or elsewhere in this prospectus supplement and in supplement, the accompanying base prospectus and the documents incorporated or deemed incorporated herein or therein by reference, including but not limited to the risk factors incorporated by reference under the captions “"Item 1A. Risk Factors,” “Business,” and “Management’s Discussion and Analysis " to Part I of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2014 and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all other factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained described elsewhere in this prospectus supplement is accurate as of any date other than or in our current and future filings with the date on the front of this prospectus supplementSEC, which address various factors that could cause results or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation events to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated described in these the forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals to persons acting on our behalf are expressly qualified in their entirety by this Notethe applicable cautionary statements. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred We have no plans to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differupdate these forward-looking statements.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus prospectus, and the documents we file with the SEC that are incorporated in this prospectus by reference herein and therein reference, contain “forward-looking statements. These statements are based on our management’s current beliefs, expectations and assumptions about future events, conditions and results and on information currently available to us. Discussions containing these forward-looking statements may be found, among other places, in the sections titled “Business,” within “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” incorporated by reference from our most recent Annual Report on Form 10-K and our most recent subsequent Quarterly Report on Form 10-Q, as well as any amendments thereto, filed with the SEC. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “positioned,” “potential,” “seek,” “should,” “target,” “will,” “would” or the negative or plural of those terms, and similar expressions intended to identify statements about the future, although not all forward-looking statements contain these words. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these statements. Any statements in this prospectus, or incorporated herein by reference, about our expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are forward-looking statements. Within the meaning of Section 27A of the Securities Act of 1933, as amended (“Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), ) these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect include statements regarding: ● our plans to usresearch, specificallydevelop and commercialize our product candidates; ● the initiation, progress, success, cost and timing of our clinical trials and product development activities; ● the therapeutic potential of our product candidates, and the biotechnology sectordisease indications for which we intend to develop our product candidates; ● our ability and timing to advance our product candidates into, and to successfully initiate, conduct, enroll and complete, clinical trials; ● our ability to manufacture our product candidates for clinical development and, if approved, for commercialization, and the timing and costs of such manufacture; ● the performance of third parties in general. We make these statements pursuant connection with the development and manufacture of our product candidates, including third parties conducting our clinical trials as well as third-party suppliers and manufacturers; ● the potential of our cell therapy platform, and our plans to apply our platform to research, develop and commercialize our product candidates; ● our ability to obtain funding for our operations, including funding necessary to initiate and complete clinical trials of our product candidates; ● the safe harbor provisions size and growth of the Private Securities Litigation Reform Act potential markets for our product candidates and our ability to serve those markets; ● the potential scope and value of 1995. Statements that include our intellectual property rights; ● our ability, and the words “expect,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” ability of our licensors, to obtain, maintain, defend and similar statements enforce intellectual property rights protecting our product candidates, and our ability to develop and commercialize our product candidates without infringing the proprietary rights of a future or forward-looking nature identify forward-looking statements for purposes third parties; ● our ability to recruit and retain key personnel; ● the potential effects of the federal securities laws or otherwise. All forward-looking statements involve inherent COVID-19 pandemic on our operations; ● our expected use of proceeds from any offering under this prospectus; and ● other risks and uncertainties, including those described in the “Risk Factors” section of the documents that are incorporated by reference into this prospectus. You should refer to the “Risk Factors” section contained in the applicable prospectus supplement and there any related free writing prospectus, and under similar headings in the other documents that are or will be incorporated by reference into this prospectus, for a discussion of important factors that could may cause our actual results to differ materially from those indicated in these expressed or implied by our forward-looking statements. We believe that Given these factors includerisks, but are not limited touncertainties and other factors, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all many of which are beyond our control, we cannot assure you should review carefully. Please consider our that the forward-looking statements in light of those risks as you read this prospectus supplement will prove to be accurate, and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- forward-looking statements. You Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not assume regard these statements as a representation or warranty by us or any other person that the information contained we will achieve our objectives and plans in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplementspecified time frame, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by referenceat all. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these revise any forward-looking statementsstatements to reflect events or developments occurring after the date of this prospectus, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differ.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and Memorandum, including the accompanying base prospectus and White Paper, contains forward-looking statements. Except for the documents we file with statements of historical fact contained herein, the SEC that are incorporated by reference herein and therein contain information presented constitutes “forward-looking statements.” within the meaning of Section 27A of the Securities ActOften, and Section 21E of the Securities Exchange Act of 1934but not always, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, and can be identified by the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions use of the Private Securities Litigation Reform Act of 1995. Statements that include the words such as “expectplans,” “intendexpects,” “planbudget,” “believescheduled,” “projectestimates,” “estimateforecasts,” “mayintends,” “shouldanticipates,” “anticipatebelieves,” “will” or variation of such words and similar statements of a future phrases that refer to certain actions, events or forward-looking nature identify results to be taken, occur or achieved. The forward-looking statements for purposes of are contained principally in the federal securities laws or otherwiseWhite Paper. All forwardForward-looking statements involve inherent risks known and uncertaintiesunknown risks, uncertainties and there are other factors which may cause the actual results, performance or will achievements of Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include those factors discussed in the section of this Memorandum entitled “Risk Factors.” Although Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those indicated described in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended. There can be no assurance that such statements in light of those risks will prove to be accurate as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to and future events could differ materially from those contained anticipated in any forward-looking statements we may makesuch statements. Given these uncertaintiesAccordingly, you readers should not place undue reliance on these forward- forward-looking statements. You should not assume that the information contained in this prospectus supplement is accurate Also, forward-looking statements represent Company’s estimates and assumptions only as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of this Memorandum. You should read this Memorandum completely and with the document so incorporated by referenceunderstanding that Company’s actual future results may be materially different from what it expects. Except as required by law, we assume Company assumes no obligation to update these any forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these any forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differ.
Appears in 1 contract
Samples: Subscription & Purchase Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and supplement, the accompanying base prospectus and the other documents we file have filed with the SEC that are incorporated herein by reference herein contain forward-looking statements that involve substantial risks and therein contain “uncertainties. All statements, other than statements of historical facts, regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans, objectives of management or other financial items are forward-looking statements. The words “anticipate,” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “believepredict,” “project,” “estimatewill,” “may,” “should,” “anticipate,” “willwould” and similar statements of a future or forward-looking nature expressions are intended to identify forward-looking statements for purposes of the federal securities laws or otherwise. All statements, although not all forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in contain these statementsidentifying words. We believe that these factors includemay not actually achieve the plans, but are not limited to, those factors set forth under the caption “Risk Factors” intentions or expectations disclosed in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement statements, and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this prospectus supplement, particularly as set forth and incorporated by reference in the “Risk Factors” section above, that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, collaborations or investments we may make. You should not assume read this prospectus supplement, the accompanying prospectus and the documents that the information contained we incorporate by reference in this prospectus supplement completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements, except as otherwise required by law. We advise you, however, to consult any further disclosures we make on related subjects in our future annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K we file with or furnish to the SEC. We intend to use the net proceeds from this offering for our planned clinical trials, preclinical programs, for other research and development activities and for general corporate purposes. Because there is accurate no minimum offering amount required as a condition to close this offering, the actual total public offering amount, commissions and proceeds to us, if any, are not determinable at this time. There can be no assurance that we will sell any shares under or fully utilize the sales agreement with the Agents as a source of financing. The amount and timing of our use of the net proceeds from any date other than offerings hereunder will depend on a number of factors, such as the timing and progress of our clinical trial efforts and pre-clinical programs. As of the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should cannot assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully specify with certainty all of the factors set forth or referred particular uses for the net proceeds to in us from this prospectus supplement and offering. Accordingly, our management will have broad discretion in the accompanying base prospectus that could cause actual timing and application of these proceeds. Pending application of the net proceeds as described above, we intend to temporarily invest the proceeds in short-term, interest-bearing instruments. We have never declared or paid any cash dividends on our capital stock, and we do not currently intend to pay any cash dividends on our common stock for the foreseeable future. We expect to retain future earnings, if any, to fund the development and growth of our business. Any future determination to pay dividends on our common stock will be at the discretion of our board of directors and will depend upon, among other factors, our results to differof operations, financial condition, capital requirements and any contractual restrictions.
Appears in 1 contract
Samples: At Market Issuance Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus, each prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are information incorporated by reference herein in this prospectus and therein each prospectus supplement contain “forward-looking statements” statements within the meaning of Section 27A of the Securities Act, Act and Section 21E of the Securities Exchange Act of 1934, as amended (amended, or the “Exchange Act”), these statements reflect that involve a number of risks and uncertainties. Although our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect reflect the good faith judgment of our management, these statements can only be based on facts and factors currently known by us. Consequently, these forward-looking statements are inherently subject to us, specificallyrisks and uncertainties, and actual results and outcomes may differ materially from results and outcomes discussed in the biotechnology sector, in generalforward-looking statements. We make these Forward-looking statements pursuant to can be identified by the safe harbor provisions use of the Private Securities Litigation Reform Act of 1995. Statements that include the forward-looking words such as “expectbelieves,” “intendexpects,” “hopes,” “may,” “will,” “plan,” “believeintends,” “projectestimates,” “estimate,” “maycould,” “should,” “anticipatewould,” “willcontinue,” “seeks,” “pro forma,” or “anticipates,” or other similar words (including their use in the negative), or by discussions of future matters such as the development of new products, technology enhancements, possible collaborations and similar other statements of a future or forward-looking nature identify forward-looking that are not historical. These statements for purposes of the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, include but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and to statements under the captions “Risk FactorsBusiness,” “Business,Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and in other sections incorporated by reference from our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, as applicable, as well as our other filings with the SEC. You should be aware that the occurrence of any of the events discussed under the heading “Risk Factors” in any applicable prospectus supplement and any documents incorporated by reference herein or therein could substantially harm our business, operating results and financial condition and that if any of these events occurs, it could adversely affect the value of an investment in our securities. The cautionary statements made in this prospectus are intended to be applicable to all of which you should review carefully. Please consider our related forward-looking statements wherever they may appear in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may makeprospectus supplement or any documents incorporated by reference herein or therein. Given these uncertainties, We urge you should not to place undue reliance on these forward- forward-looking statements. You should not assume that the information contained in this prospectus supplement is accurate , which speak only as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by referencethey are made. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these our forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that The following table sets forth our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more ratio of these or other risks or uncertainties materializes, or if earnings to fixed charges and the ratio of our underlying assumptions prove combined fixed charges and preferred dividends to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all earnings for each of the factors periods indicated. The following table is qualified by the more detailed information appearing in the computation table set forth or referred in Exhibit 12.1 to the registration statement of which this prospectus is part and the historical financial statements, including the notes to those financial statements, incorporated by reference in this prospectus supplement prospectus. We have paid no dividends on preferred shares during the periods indicated. Therefore, the ratios of earnings to combined fixed charges and preferred dividends are the same as the ratio of earnings to fixed charges. March 31, 2015 2016 2017 2018 (in thousands) Ratio of earnings to fixed charges N/A N/A N/A N/A Ratio of earnings to combined fixed charges and preferred stock dividends N/A N/A N/A N/A Deficiency of earnings available to cover fixed charges $ (23,056) $ (33,478) $ (38,929) $ (12,880) Deficiency of earnings available to cover combined fixed charges and preferred stock dividends $ (23,056) $ (33,478) $ (38,929) $ (12,880) For purposes of computing the accompanying base prospectus that could cause actual results ratio of earnings to differfixed charges and the ratio of our combined fixed charges and preferred stock dividends to earnings, earnings consist of income (loss) from continuing operations before income taxes plus fixed charges. Fixed charges consist of interest expense on indebtedness and an estimate of the interest within rental expense. We did not record earnings for any of the years ended December 31, 2015, 2016, and 2017 or for the three months ended March 31, 2018. Accordingly, our earnings were insufficient to cover fixed charges for such periods and we are unable to disclose a ratio of earnings to fixed charges for such periods.
Appears in 1 contract
Samples: At Market Issuance Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and prospectus, including the documents we file with the SEC that are incorporated by reference herein and therein in this prospectus, may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act, Act and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, and are often identified by the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions use of the Private Securities Litigation Reform Act of 1995. Statements that include the words such as “may,” “will,” “expect,” “believe,” “anticipate,” “intend,” “plan,” “believe,” “project,” “estimate,” “maycould,” “should,” “anticipateestimate” or “continue,” “will” and similar expressions or variations. All statements other than statements of a future or historical fact could be deemed forward-looking nature identify looking, including, but not limited to: any projections of financial information or performance; any statements about historical results that may suggest trends for our business; any statements of the plans, strategies, and objectives of management for future operations; any statements of expectation or belief regarding future events, technology developments, our products and product candidates, product sales, revenues, expenses, liquidity, cash flow, commercial reach, market growth rates or enforceability of our intellectual property rights and related litigation expenses; our intended use of the net proceeds from offerings; and any statements of assumptions underlying any of the foregoing. Such forward-looking statements for purposes of the federal securities laws or otherwise. All forward-looking statements involve inherent risks are subject to risks, uncertainties and uncertainties, and there are or will be important other factors that could cause actual results and the timing of certain events to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our future results expressed or implied by such forward-looking statements in light of those risks as statements. Accordingly, we caution you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that We discuss many of these risks in greater detail in the information contained in this prospectus supplement is accurate documents incorporated by reference herein, including under the heading “Risk Factors.” These forward-looking statements represent our estimates and assumptions only as of any date other than the date on the front dates of this prospectus supplement, or that any information and the documents incorporated by reference into herein and therein, and any free writing prospectus, as applicable, regardless of the time of delivery of this prospectus supplement is accurate as or any sale of any date other than the date of the document so incorporated by reference. Except our common stock and, except as required by law, we assume undertake no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these revise publicly any forward-looking statements, even if whether as a result of new information becomes available in information, future events or otherwise after the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more date of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differprospectus.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are incorporated herein by reference herein and therein contain “forward-looking statements” within the meaning of Section 27A of the Securities Act, Act and Section 21E of the Securities Exchange Act about us and our industry that involve substantial risks and uncertainties. All statements other than statements of 1934, as amended (historical fact contained in this document and the “Exchange Act”), these materials accompanying this document are forward-looking statements. These statements reflect our are based on current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other expectations of future events. These statements include Frequently, but not always, forward-looking statements both with respect to us, specifically, and are identified by the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions use of the Private Securities Litigation Reform Act of 1995. Statements that include the future tense and by words such as “expectbelieves,” “intendexpects,” “plananticipates,” “believeintends,” “project,” “estimatewill,” “may,” “shouldcould,” “anticipatewould,” “willprojects,” and “continues,” “estimates” or similar statements of a future or forward-looking nature identify forwardexpressions. Forward-looking statements for purposes are not guarantees of the federal securities laws or otherwise. All forward-looking statements involve inherent risks future performance and uncertainties, and there are or will be important factors that could cause actual results to could differ materially from those indicated in these by such forward-looking statements. We believe Forward-looking statements involve known and unknown risks, uncertainties and other factors that these may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by the forward-looking statements. These forward-looking statements speak only as of the date made and are subject to a number of known and unknown risks, uncertainties and assumptions, including the important factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in incorporated by reference into this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in from our most recent Annual Report on Form 10-K and our any subsequent Quarterly Reports on Form 10-Q/10Q and Current Reports on Form 8-Q/AK, and all other information contained or incorporated by reference into this prospectus, as updated by our subsequent filings under the Exchange Act and in our other filings with the SEC, that may cause our actual results, performance or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should review carefullynot rely on these forward-looking statements as predictions of future events. Please consider The events and circumstances reflected in our forward-looking statements in light of those risks as you read this prospectus supplement may not be achieved or occur, and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated projected in these the forward- looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements, even if whether as a result of any new information becomes available in the future. Thusinformation, you should not assume that our silence over time means that actual events are bearing out as expressed future events, changed circumstances or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differotherwise.
Appears in 1 contract
Samples: At the Market Offering Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file with the SEC The statements contained in this information statement that are incorporated by reference herein and therein contain “not purely historical are forward-looking statements” statements within the meaning of Section 27A of the Securities ActAct of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)amended. All statements other than statements of historical facts contained or incorporated herein by reference in this information statement, these including statements reflect regarding our current views with respect to our ongoing and planned clinical trialsfuture operating results, future financial position, business strategy, business planobjectives, financial performance goals, plans, prospects, markets, and other plans and objectives for future eventsoperations, are forward-looking statements. These statements include In some cases, you can identify forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words by terms such as “expectanticipates,” “intendbelieves,” “estimates,” “expects,” “intends,” “targets,” “contemplates,” “projects,” “predicts,” “may,” “might,” “plan,” “believewill,” “projectwould,” “estimateshould,” “could,” “may,” “shouldcan,” “anticipatepotential,” “willcontinue,” and “objective,” or the negative of those terms, or similar statements of a future or forward-looking nature expressions intended to identify forward-looking statements. However, not all forward-looking statements for purposes contain these identifying words. Specific forward-looking statements in this information statement, include statements regarding our expectations regarding the methodology, effects, timing, and tax-free nature of the Separation; our belief that SilverSun will meet the requisite requirements under Delaware law to effect the Separation; our belief that no other material governmental or regulatory filings or approvals will be necessary to consummate the Separation, other than registration under the federal securities laws of our common stock and completion of the applicable trading requirements on the OTCQX for such shares; our expectation that our common stock will be traded on the OTCQX under the ticker symbol “[●]”; our expectation that after the Separation and the Mergers , SilverSun common stock will be traded on Nasdaq under the ticker symbol “RHDM”; our expectations regarding a “regular-way” market, an “ex-distribution” market, and a “when-issued” market in our shares of common stock between the Record Date and the Distribution Date; our belief that separating SilverSun’s businesses operated through SWK and SCS from SilverSun’s business operated through CCDC and, following the Mergers, Merger Sub II, is in the best interests of SilverSun and its stockholders; our expectations regarding the number of shares of our outstanding common stock, the number of such shares held by our affiliates, and the number of stockholders of record following the Separation; our anticipation regarding the adverse effects of COVID-19 on our business; our belief that maintaining and further enhancing the brand recognition and reputation of our brands is critical to retaining existing customers and attracting new customers and that the importance of our brand recognition and reputation will increase; our plan to continue to expand our brand recognition and product loyalty through social media and our websites with generation of original content; our anticipation that we will enter into new strategic alliances; our expectation that any claims and lawsuits, arising in the ordinary course of business, we are involved in will not have a material adverse effect on our results of operations or otherwisefinancial condition; our intent to pursue acquisitions that financially and strategically complement our business; our belief that we will drive customer satisfaction and loyalty by offering high-quality, innovative products and services on a timely and cost-effective basis; our intent to pursue and challenge infringements of our intellectual property; our expectation to have certain insurance policies in place as of the date of the Separation; our anticipation that any required contract assignments and new agreements will be obtained prior to the Separation; our belief that none of the contracts or other assets requiring consent to transfer or the contracts requiring a new agreement are individually material to our business; our expectation that the expenses to be incurred by SilverSun Holdings for reporting and corporate governance purposes will be commensurate with those being incurred by SilverSun prior to the Mergers; our expected executive officers, directors, and other key employees; our expected corporate governance policies, guidelines, and practices; our anticipated compensation and benefit plans;our belief that several provisions of our Certificate of Incorporation, Bylaws, and Delaware law that may discourage, delay, or prevent a merger or acquisition that stockholders may consider favorable and will protect our stockholders from coercive or otherwise unfair takeover tactics; our expectations of costs and expenses associated with becoming an independent, publicly traded company; our expectation to incur expenditures to establish certain standalone functions, and other one-time costs subsequent to the completion of the Separation; our expectation that nonrecurring amounts, related to the Separation that are incurred prior to the completion of the Separation, will include costs to separate and/or duplicate investment banker fees, third-party legal and accounting fees, and similar costs; our belief we will meet known or reasonably likely future cash requirements through the combination of cash flows from operating activities, available cash balances, and available borrowings through the issuance of third-party debt; and our expectation to utilize our cash flows to continue to invest in our brands, including research and development of new product initiatives, talent and capabilities, and growth strategies, including any potential acquisitions, and to repay any indebtedness we may incur over time. All forward-looking statements involve inherent risks included herein are based on information available to us as of the date hereof and speak only as of such date. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements. The forward-looking statements contained in or incorporated by reference into this information statement reflect our views as of the date of this information statement about future events and are subject to risks, uncertainties, assumptions, and there changes in circumstances that may cause our actual results, performance, or achievements to differ significantly from those expressed or implied in any forward-looking statement. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future events, results, performance, or will be important achievements. A number of factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more Such factors include, among others: the effects of these or other risks or uncertainties materializesthe coronavirus, or if COVID-19, pandemic; lower levels of consumer spending; our underlying assumptions prove ability to be incorrectintroduce new products that are successful in the marketplace; the failure to maintain or strengthen our brand recognition and reputation; the ability to forecast demand for our products or services accurately; our inability to compete in a highly competitive market; our dependence on large customers; pricing pressures by our customers; our ability to collect our accounts receivable the risk of earthquakes, actual results may vary materially from what we anticipate. All subsequent written fire, power outages, power losses, and oral forward-looking statements attributable telecommunication failures; our abilities to us identify acquisition candidates, to complete acquisitions of potential acquisition candidates, our ability to integrate their businesses with our business, and the success of acquired companies; our ability to protect our intellectual property; the risk of complying with any applicable foreign laws or individuals acting regulations and the effect of increased protective tariffs; the performance and security of our information systems; the potential for product recalls, product liability, and other claims against us; our dependable on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stockkey personnel; economic, you should consider carefully all social, political, legislative, and regulatory factors; the state of the U.S. economy; risks associated with our facilities, including the expected benefits; and other factors set forth detailed from time to time in our reports that will be filed with the Securities and Exchange Commission, or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differSEC.
Appears in 1 contract
Samples: Merger Agreement (SilverSun Technologies Holdings, Inc)
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are incorporated by reference herein into this prospectus and therein any prospectus supplement or free writing prospectus may contain “forward-forward- looking statements” within the meaning of Section 27A of the Securities Act, Act and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, only provide our current expectations or forecasts of future events and financial performance and may be identified by the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions use of the Private Securities Litigation Reform Act of 1995. Statements that include the words such terms as “expectbelieves,” “intendestimates,” “plananticipates,” “believeexpects,” “projectplans,” “estimateintends,” “may,” “will,” “should,” “anticipatecould,” “willpredicts” or the negative thereof, or other variations or comparable terminology, though the absence of these words does not necessarily mean that a statement is not forward-looking. Forward-looking statements include all matters that are not historical facts and similar include, without limitation, statements concerning our business strategy, outlook, objectives, future milestones, plans, intentions, goals, and future financial condition, including the period of a future time for which our existing resources will enable us to fund our operations. You should read carefully the risks described in the section entitled “Risk Factors” beginning on page 4 of this prospectus, and in any accompanying prospectus supplement or related free writing prospectus, together with all information incorporated by reference herein and therein, to better understand the significant risks and uncertainties inherent in our business and underlying any forward-looking nature identify statements. Our actual results could differ materially from those contained in the forward-looking statements for purposes of due to the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated described in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption section entitled “Risk Factors” in beginning on page 4 of this prospectus supplement and prospectus; in the accompanying base prospectus and under the captions sections entitled “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our the Company’s most recent Annual Report on Form 10-K K; and our subsequent in the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s most recent Quarterly Reports Report on Form 10-Q/10-Q/AQ. In addition, all many important factors may affect our ability to achieve our plans and objectives and to successfully develop and commercialize our products and product candidates. Our results may be affected by our ability to manage our financial resources, as well as difficulties or delays in developing manufacturing processes for our products and product candidates, preclinical and toxicology testing and regulatory developments. Delays in clinical programs, whether caused by competitive developments, adverse events, patient enrollment rates, regulatory issues or other factors, could adversely affect our financial position and prospects. Prior clinical trial program designs and results are not necessarily indicative of which you should review carefullyfuture clinical trial designs or results. Please consider If our product candidates do not meet safety or efficacy endpoints in clinical evaluations, they will not receive regulatory approval and we will not be able to market them. We may not be able to successfully manage the balance of our research and development operations with our planned commercialization activities. We may not be able to enter into any strategic partnership agreements. Operating expenses and cash flow projections involve a high degree of uncertainty, including variances in future spending rates due to changes in corporate priorities, the timing and outcomes of clinical trials, competitive developments and the impact on expenditures and available capital from licensing and strategic collaboration opportunities. If we are unable to raise additional capital when required or on acceptable terms, we may have to significantly delay, scale back or discontinue one or more of our drug development or discovery research programs and delay or abandon actual or potential commercialization efforts. We may not ever have any products that generate significant revenue. There can be no assurance that the forward-looking statements included in light of those risks as you read this document will prove to be accurate. Any forward-looking statements that we make in this prospectus supplement speak only as of the date of such statements and the accompanying base prospectus. It is not possible for our management we undertake no obligation to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in publicly update any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of or to publicly announce revisions to any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if whether as a result of new information becomes available in information, future events or otherwise, except as may otherwise be required by the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differfederal securities laws.
Appears in 1 contract
Samples: Open Market Sale Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This Information presented in this prospectus, any accompanying prospectus supplement and the accompanying base any free writing prospectus prepared by or on behalf of us or to which we have referred you, and the in other documents we file with the SEC that which are incorporated by reference herein in this prospectus under the sections of this prospectus entitled “Where You Can Find More Information” and therein contain “Information Incorporated by Reference,” that discusses financial projections, information or expectations about our business plans, results of operations, products or markets, or otherwise makes statements about future events, are forward-looking statements. Forward-looking statements can be identified by the use of words such as “intends,” within “anticipates,” “believes,” “estimates,” “projects,” “forecasts,” “expects,” “plans,” and “proposes.” Although we believe that the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), expectations reflected in these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to us, specifically, and the biotechnology sector, in general. We make differ materially from these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words “expect,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or forward-looking nature statements. These include, among others, the cautionary statements in the “Risk Factors” section of this prospectus beginning on page 4. These cautionary statements identify forward-looking statements for purposes of the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated described in these the forward-looking statements. We believe that these factors includeWhen considering forward-looking statements in this prospectus, but are not limited to, those factors set forth under you should keep in mind the caption cautionary statements in the “Risk Factors” section and other sections of this prospectus, and other cautionary statements in any accompanying prospectus supplement and any free writing prospectus prepared by or on behalf of us or to which we have referred you and any documents which are incorporated by reference in this prospectus supplement and listed in the accompanying base prospectus and under the captions “Risk Factors,” “Business,Where You Can Find More Information” and “Management’s Discussion Information Incorporated by Reference” beginning on pages 23 and Analysis of Financial Condition 24, respectively. Certain risks, uncertainties, and Results of Operations,” in other factors are incorporated herein by reference to our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and along with the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the other information contained in this prospectus supplement is accurate prospectus, as updated by our subsequent filings under the Securities Exchange Act of any date other than the date on the front of this prospectus supplement1934, as amended, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. “Exchange Act.” Except as otherwise required by lawapplicable securities laws, we assume undertake no obligation to publicly update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these revise any forward-looking statements, even if whether as a result of new information becomes available in the future. Thusinformation, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializesfuture events, changed circumstances, or if our underlying assumptions prove to be incorrectany other reason, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by after the date of this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differprospectus.
Appears in 1 contract
Samples: Credit Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file have filed with the SEC that are incorporated by reference herein and therein contain “forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these . These statements reflect our current views with respect relate to future events or to our ongoing and planned clinical trials, business strategy, business plan, future operating or financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future eventsresults, performances or achievements expressed or implied by the forward-looking statements. These All statements include other than statements of historical facts contained in this prospectus, including statements regarding our future results of operations and financial condition, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the may be identified by words such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “believepositioned,” “projectpotential,” “estimatepredict,” “mayseek,” “should,” “anticipatetarget,” “will,” and “would,” or the negative of these terms or other similar statements of a future or forward-looking nature identify expressions. We have based these forward-looking statements for purposes largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of the federal securities laws or otherwiseoperations, business strategy and financial needs. All These forward-looking statements involve inherent are subject to a number of known and unknown risks, uncertainties and assumptions, including risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated described in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption section titled “Risk Factors” and elsewhere in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K K, as well as any amendments thereto reflected in subsequent filings with the SEC, which are incorporated by reference into this prospectus in their entirety, together with other information in this prospectus, the documents incorporated by reference and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefullyany free writing prospectus that we may authorize for use in connection with a specific offering. Please consider our forwardForward-looking statements in light may include, but are not limited to, statements about: • our expectations regarding the potential market size and size of those the potential patient populations for our product candidates and any future product candidates, if approved for commercial use; • our clinical and regulatory development plans; • our expectations with regard to the results of our clinical studies, preclinical studies and research and development programs, including the timing and availability of data from such studies; • the timing of commencement of future nonclinical studies and clinical trials and research and development programs; • our ability to acquire, discover, develop and advance product candidates into, and successfully complete, clinical trials; • our intentions and our ability to establish collaborations and/or partnerships; • the timing or likelihood of regulatory filings and approvals for our product candidates; • our commercialization, marketing and manufacturing capabilities and expectations; • our intentions with respect to the commercialization of our product candidates; • the pricing and reimbursement of our product candidates, if approved; • the implementation of our business model and strategic plans for our business and product candidates, including additional indications for which we may pursue; • the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates, including the projected terms of patent protection; • estimates of our expenses, future revenue, capital requirements, our needs for additional financing and our ability to obtain additional capital; • our intended use of proceeds from this offering and our existing cash, cash equivalents and marketable securities; • the potential future sales of our common stock under our at-the-market offering program; • our future financial or operating performance; and • developments and projections relating to our competitors and our industry, including competing products. These risks as you read are not exhaustive. Other sections of this prospectus supplement may include additional factors that could harm our business and the accompanying base prospectusfinancial performance. It Moreover, we operate in a very competitive and rapidly changing environment. New risks and uncertainties emerge from time to time, and it is not possible for our management to predict all risksrisks and uncertainties, nor can we assess the impact of all such factors on our business or the extent to which any such factor, or combination of such factors, may cause actual results to differ materially from those contained in in, or implied by, any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume rely upon forward-looking statements as predictions of future events. Although we believe that the information contained expectations reflected in this prospectus supplement is accurate as the forward-looking statements are reasonable, we cannot guarantee future results, levels of any date other than the date on the front of this prospectus supplementactivity, performance or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by referenceachievements. Except as required by law, we assume undertake no obligation to update these publicly any forward-looking statements publiclyfor any reason after the date of this prospectus or to conform these statements to actual results or to changes in our expectations. In addition, statements containing the words “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this prospectus, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all relevant information. These statements are inherently uncertain and investors are cautioned not to update unduly rely upon these statements. You should read this prospectus, any applicable prospectus supplement, together with the reasons actual results could differ materially from those anticipated documents we have filed with the SEC that are incorporated by reference herein and therein and any free writing prospectuses that we may authorize for use in these forward-looking statements, even if new information becomes available in connection with a specific offering completely and with the future. Thus, you should not assume understanding that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more future results, levels of these or other risks or uncertainties materializesactivity, or if our underlying assumptions prove to performance and achievements may be incorrect, actual results may vary materially different from what we anticipateexpect. All subsequent written and oral We qualify all of our forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differthese cautionary statements.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file have filed with the SEC that are incorporated by reference herein and therein contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (amended, or the “Exchange Act”). These statements relate to future events or to our future operating or financial performance and involve known and unknown risks, these uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. Forward-looking statements include, but are not limited to, statements about: • our ability to successfully develop ibrexafungerp, including an IV formulation of ibrexafungerp; • our expectations regarding the benefits we will obtain from the oral and IV form of ibrexafungerp having been designated as a QIDP; • our ability to obtain FDA approval of ibrexafungerp; • our expectations regarding the devotion of our resources; • our expected uses of the net proceeds to us from this offering; • the expected costs of studies and when they will begin; • our ability to scale up manufacturing to commercial scale; • our reliance on third parties to conduct our clinical studies; • our reliance on third-party contract manufacturers to manufacture and supply commercial supplies of ibrexafungerp for us; • our expectations regarding the marketing of ibrexafungerp should we receive regulatory approval; • our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing; • our financial performance; and • developments and projections relating to our competitors or our industry. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “predict,” “potential” and similar expressions intended to identify forward-looking statements. These statements reflect our current views with respect to our ongoing future events and planned clinical trials, business strategy, business plan, financial performance are based on assumptions and other future events. These statements include forward-looking statements both with respect are subject to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words “expect,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or forward-looking nature identify forward-looking statements for purposes of the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- forward-looking statements. You should not assume that We discuss in greater detail many of these risks under the information heading “Risk Factors” contained in this prospectus supplement is accurate and the accompanying prospectus, in any free writing prospectuses we may authorize for use in connection with this offering, and in our most recent annual report on Form 10-K and in our most recent quarterly report on Form 10-Q, as of well as any date other than amendments thereto reflected in subsequent filings with the date on the front of this prospectus supplementSEC, or that any information which are incorporated by reference into this prospectus supplement is accurate and the accompanying prospectus in their entirety. Also, these forward-looking statements represent our estimates and assumptions only as of any date other than the date of the document so incorporated by referencecontaining the applicable statement. Except as Unless required by law, we assume undertake no obligation to update these or revise any forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if reflect new information becomes available in the futureor future events or developments. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if You should read this prospectus supplement and the accompanying prospectus together with the documents we have filed with the SEC that are incorporated by reference and any free writing prospectus that we may authorize for use in connection with this offering completely and with the understanding that our underlying assumptions prove to be incorrect, actual future results may vary be materially different from what we anticipateexpect. All subsequent written and oral We qualify all of the forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differforegoing documents by these cautionary statements.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are incorporated by reference herein and therein contain “forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include report contains forward-looking statements both with respect to us, specifically, and within the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions meaning of the Private Securities Litigation Reform Act of 1995. Statements that Forward-looking statements may be preceded by, followed by or include the words “expectbelieves,” “intendexpects,” “plananticipates,” “believeintends,” “projectplans,” “estimate,estimates” “may,” “should,” “anticipate,” “will” or similar expressions. These statements are based on the beliefs and similar statements assumptions of a future or forward-looking nature identify our management. Generally, forward-looking statements for purposes include information concerning our possible or assumed future actions, events or results of operations. Forward-looking statements specifically include, without limitation, the federal securities laws or otherwiseinformation herein regarding: projections; efficiencies/cost avoidance; cost savings; income and margins; earnings per share; growth; economies of scale; combined operations; the economy; future economic performance; conditions to, and the timetable for, completing the transactions; capital expenditures; future financing needs; future acquisitions and dispositions; litigation; potential and contingent liabilities; management’s plans; and merger and integration-related expenses. All Although we believe that the expectations reflected in the forward-looking statements involve inherent are based on reasonable assumptions, these forward-looking statements are subject to numerous factors, risks and uncertaintiesuncertainties that could cause actual outcomes and results to be materially different from those projected. We cannot guarantee future results, performance or achievements. Moreover, neither we nor any other person assumes responsibility for the accuracy and there completeness of the forward-looking statements. All written and oral forward-looking statements made in connection with this report that are attributable to us or persons acting on our behalf are expressly qualified in their entirety by “Risk Factors” and other cautionary statements included herein. We are under no duty to update any of the forward-looking statements after the date hereof to conform such statements to actual results or to changes in our expectations. The information contained herein is not a complete description of our business or the risks associated with an investment in our notes. There can be no assurance that other factors will be important not affect the accuracy of these forward-looking statements or that our actual results will not differ materially from the results anticipated in such forward-looking statements. While it is impossible to identify all such factors, factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors estimated by us include, but are not limited to, those factors set forth or conditions described under the caption “Risk Factors” in this prospectus supplement and the following: • the cyclicality of the aerospace market and the level of new commercial aircraft orders; • customer concentration; • production rates for various commercial and military aircraft programs; • the level of U.S. defense spending; • competitive pricing pressures; • manufacturing inefficiencies; • start-up costs and possible overruns on new contracts; • technology and product development risks and uncertainties; • product performance; • increasing consolidation of customers and suppliers in the accompanying base prospectus aerospace industry; • price erosion within the electronics manufacturing services marketplace; • the risk of environmental liabilities; • possible goodwill impairment; • compliance with applicable regulatory requirements and under changes in regulatory requirements, including regulatory requirements applicable to government contracts and sub-contracts; • imposition of taxes, export controls, tariffs, embargoes and other trade restrictions; • economic and geopolitical developments and conditions; • our ability to service our substantial indebtedness; • our ability to manage and otherwise comply with our covenants with respect to our significant outstanding indebtedness; • unfavorable developments in the captions “Risk Factors,” “Business,” global credit markets, which may make it more difficult to incur new indebtedness or refinance our outstanding indebtedness; • the risk that XxXxxxx’x business, operations and “Management’s Discussion employees will not be integrated successfully with our business and Analysis operations; • our inability to recognize the benefits of Financial Condition the Merger, including any potential synergies, growth, cost savings or accretive value; • our ability to retain key employees following the Merger; • our inability to maintain current customer and Results supplier relationships following the Merger; • the risk that the Merger disrupts current plans and operations; • litigation in respect of Operations,” in our most recent Annual Report on Form 10-K either XxXxxxx, the Merger or us; • the amount of the costs, fees, expenses and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement charges related to the Merger and the accompanying base prospectusfinancings for the Merger, including the notes offering; • the method of accounting for the Merger; and • risks associated with other acquisitions and dispositions of businesses by us. It is We caution the reader that undue reliance should not possible for our management to predict all risks, nor can we assess the impact of all factors be placed on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertaintiesstatements, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate which speak only as of any date other than the date on the front of this prospectus supplement, hereof. We do not undertake any duty or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation responsibility to update any of these forward-looking statements publicly, to reflect events or circumstances after the date hereof or to update reflect actual outcomes. Ducommun provides engineering and manufacturing services primarily to the reasons actual results could differ materially from those anticipated aerospace and defense industry. We design, engineer and manufacture mission-critical aerostructure and electromechanical components and subassemblies. We also provide engineering, technical and program management services. Our products and services are used on domestic and foreign commercial and military aircraft, helicopter, missile and space programs. We are the successor to a business that was founded in these forwardCalifornia in 1849 and reincorporated in Delaware in 1970. On April 3, 2011, we entered into a Merger Agreement to acquire XxXxxxx for approximately $338.1 million comprised of approximately $310.3 million in equity and $27.8 million of outstanding XxXxxxx debt, which will be repaid at closing of the Merger. XxXxxxx provides custom high-looking statementsperformance electronic, even if new information becomes available electromechanical and interconnect systems on a contractual basis for customers in the futureaerospace and defense and several other markets. ThusWe believe our acquisition of XxXxxxx (the “XxXxxxx Acquisition”) will allow us to significantly expand our existing presence in the aerospace and defense industry as well as to diversify our net sales base across new markets, you should not assume that our silence over time means that actual events are bearing out including industrial, natural resources and medical. Pursuant to the Merger Agreement, subject to the satisfaction of certain conditions, Merger Sub will be merged with and into XxXxxxx, with XxXxxxx (which will be renamed Xxxxxxxx XxXxxxx Technologies, Inc.) continuing as expressed or implied the surviving corporation and a wholly-owned subsidiary of Ducommun. In the Merger, each outstanding share of XxXxxxx common stock will be cancelled and converted (subject to the exercise of appraisal rights) into the right to receive $19.25 per share in such forward-looking statementscash. If one or more of these or other risks or uncertainties materializesThe proceeds from the notes offered, or if our underlying assumptions prove together with borrowings under the New Credit Facilities will be used to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all finance the cost of the factors XxXxxxx Acquisition, refinance certain existing indebtedness of Ducommun and XxXxxxx, pay fees and expenses in connection with the Transactions and add new cash to our balance sheet. Incorporated in 1968, XxXxxxx provides EMS services, which involves the manufacture of custom, complex, high-reliability and mission-critical products for customers in diverse technology-driven markets, such as the aerospace and defense, industrial, natural resources, medical and other commercial markets. XxXxxxx markets its services to customers desiring a manufacturing and engineering partner capable of developing and providing products that can perform reliably in harsh environmental conditions, such as extreme temperatures, severe shock and vibration and with rapid turnaround time. The sophistication and complexity of the products XxXxxxx designs and manufactures require superior quality. XxXxxxx is capable of quickly producing multiple sophisticated electronics products utilizing the same manufacturing set forth or referred up resulting in increased efficiency and higher margins as compared to in this prospectus supplement less-sophisticated high-volume product lines. This low-volume and in high-mix production expertise, together with its lean manufacturing culture and service driven business model, enables XxXxxxx to consistently achieve attractive profit margins relative to other industry participants that may focus on high-volume and low-mix products. For the accompanying base prospectus that could cause actual results twelve months ended April 3, 2011, on a stand-alone basis, XxXxxxx generated net sales of $332.5 million and Adjusted EBITDA of $41.0 million. See “Summary Consolidated Historical Financial Data of XxXxxxx” for a reconciliation of net income to differAdjusted EBITDA. As of April 3, 2011, on a stand-alone basis XxXxxxx had firm backlog of $241.6 million.
Appears in 1 contract
Samples: Merger Agreement (Labarge Inc)
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are information incorporated by reference herein and therein contain in this prospectus include “forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (amended, or the “Exchange Act”), and Section 27A of the Securities Act. For these purposes, any statements reflect contained or incorporated by reference herein regarding our current views with respect to our ongoing and planned clinical trials, business strategy, business planfuture operations, financial performance position, future revenues, projected costs, prospects, plans and objectives of management, other future eventsthan statements of historical facts, are forward-looking statements. These statements include In some cases, you can identify forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include by the words “may,” “might,” “can,” “will,” “to be,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “estimatepotential,” “maylikely,” “shouldcontinue” and “ongoing,” “anticipate,” “will” and similar or the negative of these terms, or other comparable terminology intended to identify statements of a future or forward-looking nature identify about the future, although not all forward-looking statements for purposes contain these words. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the federal securities laws information expressed or otherwise. All implied by these forward-looking statements involve inherent risks and uncertaintiesstatements. We cannot guarantee that we actually will achieve the plans, and there intentions or expectations expressed or implied in our forward-looking statements. There are or will be a number of important factors that could cause actual results results, levels of activity, performance or events to differ materially from those indicated expressed or implied in these statementsthe forward-looking statements we make. We believe that these factors include, but are not limited to, those factors set forth under You should refer to the caption “Business,” “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and other sections contained in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this the applicable prospectus supplement and any related free writing prospectus, and under similar headings in the accompanying base other documents that are incorporated by reference into this prospectus. It is not possible , for our management to predict all risks, nor can we assess the impact a discussion of all important factors on our business or the extent to which any factor, or combination of factors, that may cause our actual results to differ materially from those contained in any expressed or implied by our forward-looking statements. Given these risks, uncertainties and other factors, many of which are beyond our control, we cannot assure you that the forward-looking statements we may make. Given these uncertaintiesin this prospectus will prove to be accurate, and you should not place undue reliance on these forward- forward-looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplementFurthermore, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these if our forward-looking statements publiclyprove to be inaccurate, or to update the reasons actual results could differ materially from those anticipated inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume regard these statements as a representation or warranty by us or any other person that we will achieve our silence over time means that actual events are bearing out as expressed objectives and plans in any specified timeframe, or implied in such at all. Any forward-looking statementsstatement speaks only as of the date on which it is made. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove Although we may elect to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral update forward-looking statements attributable in the future, we specifically disclaim any obligation to us or individuals acting do so, except as may be required by law, even if our estimates change, and readers should not rely on our behalf are expressly qualified in their entirety by this Note. Before purchasing forward-looking statements as representing our views as of any shares of common stock, you should consider carefully all of date subsequent to the factors set forth or referred to in this prospectus supplement and in date the accompanying base prospectus that could cause actual results to differstatements were made.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus, together with any accompanying prospectus supplement supplement, includes and the accompanying base prospectus and the documents we file with the SEC that are incorporated incorporates by reference herein and therein contain “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and releases issued by the SEC and within the meaning of Section 27A of the Securities ActAct of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the amended, which statements involve substantial risks and uncertainties. Forward-looking statements generally relate to future events or our future financial or operating performance. All statements other than statements of historical fact are “Exchange Act”)forward-looking statements” for purposes of this prospectus. In some cases, these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include you can identify forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the because they contain words such as “may,” “will,” “would,” “should,” “could,” “expect,” “plan,” “anticipate,” “intend,” “plantarget,” “project,” “contemplate,” “believe,” “project,” “estimate,” “maypredict,” “shouldseek,” “anticipatepotential,” “willongoing,” and “goal,” or “continue,” or the negative of these words or other similar statements of a future terms or forward-looking nature identify forwardexpressions that concern our expectations, strategy, plans or intentions. Forward-looking statements for purposes of the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated contained in these statements. We believe that these factors this prospectus include, but are not limited to, those factors set forth under statements about: · how long we expect to maintain liquidity to fund our planned level of operations and our ability to obtain additional funds for our operations; · the caption “Risk Factors” in this prospectus supplement identification and development of our drug and vaccine candidates, including when we expect to undertake, initiate and complete clinical trials of our candidates; · the expectation, plans, projections, initiation, timing, progress and results of our research and development programs, preclinical studies, any clinical trials, Investigational New Drug, or IND, filings, Clinical Trial Application, or CTA, filings, New Drug Application, or NDA, filings, and other regulatory submissions; · the regulatory approval of any of our drug and vaccine candidates; · our use of clinical research centers, third party manufacturers and other contractors; · our ability to find collaborative partners for research, development and commercialization of our product candidates and retain commercial rights for our product candidates in the accompanying base prospectus collaborations; · our ability to manufacture products for clinical and under commercial use; · our reliance on third party suppliers and manufacturers to supply the captions “Risk Factors,” “Business,” materials and “Management’s Discussion components for, and Analysis manufacture, our research and development, preclinical and clinical trial drug supplies; · our ability to protect our patents and other intellectual property; · our ability to commercialize and market any of Financial Condition our products; · the implementation of our business model and Results strategic plans for our business, technologies and product candidates; · our estimates of Operations,” in our most recent Annual Report expenses, ongoing losses, future revenue and capital requirements; · our ability to secure and maintain adequate protection for our patents and other intellectual property protection for our technologies and product candidates; · our ability to operate our business without infringing the intellectual property rights of others; · our reliance on Form 10-K third parties to conduct our preclinical studies or any clinical trials; · our ability to compete against other companies and research institutions; · our subsequent Quarterly Reports ability to expand our operations internationally; · the effect of potential strategic transactions on Form 10-Q/10-Q/Aour business; · the rate and degree of acceptance of our product candidates by doctors, all patients or payors and the availability of which reimbursement for our product candidates; · our financial performance; · our ability to attract and retain key personnel; and · the volatility of our stock price. We caution you should review carefully. Please consider our that the forward-looking statements highlighted above do not encompass all of the forward-looking statements made in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for These forward-looking statements relate to future events or to our management to predict all future financial performance and involve known and unknown risks, nor can we assess the impact uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. You should not rely upon forward-looking statements as predictions of all future events. In evaluating such forward-looking statements, you should specifically consider various factors on our business or the extent to which any factor, or combination of factors, that may cause actual results to differ materially from those current expectations, including the risks outlined under the heading “Risk Factors” contained in this prospectus, any prospectus supplement and any related free writing prospectus, and in any other documents incorporated herein or therein (including in our most recent annual report on Form 10-K, subsequent quarterly reports on Form 10-Q and other filings we make with the SEC pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act). We have based the forward-looking statements contained in this prospectus primarily on our current expectations and projections about future events and trends that we believe may affect our business, financial condition, results of operations and prospects. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties and other factors described in the section of this prospectus entitled “Risk Factors” and elsewhere in this prospectus, any prospectus supplement and any related free writing prospectus. Moreover, we operate in a very competitive and challenging environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this prospectus. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements. Additionally, final data may differ significantly from preliminary data reported in this document. The forward-looking statements made in this prospectus, any accompanying prospectus supplement, any related free writing prospectus and any document incorporated herein by reference relate only to events as of the date on which the statements are made. We undertake no obligation to update any forward-looking statements we made in this prospectus to reflect events or circumstances after the date of this prospectus or to reflect new information or the occurrence of unanticipated events, except as required by law. We may make. Given these uncertaintiesnot actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral Our forward-looking statements attributable to us do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or individuals acting investments we may make. This prospectus, together with any accompanying prospectus supplement, also contains statistical data, estimates, forecasts, and projections that are based on independent industry publications or other publicly available information, as well as other information based on our behalf internal sources. Information that is based on statistical data, estimates, forecasts, projections or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, we obtained these industry, business, market and other data from reports, research surveys, studies and similar data prepared by third parties, industry, medical and general publications, government data and similar sources. In some cases, we do not expressly refer to the sources from which these data are expressly qualified in their entirety by this Notederived. Before purchasing any shares of common stock, you should consider carefully all of Although we believe that the factors set forth or third-party sources referred to in this prospectus supplement are reliable, we have not independently verified the information provided by these third parties. While we are not aware of any misstatements regarding any third-party information presented in this prospectus, their estimates, in particular, as they relate to projections, involve numerous assumptions, are subject to risks and uncertainties, and are subject to change based on various factors, including those discussed under the section of this prospectus entitled “Risk Factors” and elsewhere in the accompanying base prospectus that could cause actual results to differthis prospectus.
Appears in 1 contract
Samples: Common Stock Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are incorporated by reference herein and therein contain certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical facts are forward- looking statements. In some cases, these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include you can identify forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the by words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “believepotential,” “predict,” “project,” “estimate,” “mayseek,” “should,” “anticipatetarget,” “will,” and similar statements “would,” or the negative of a future these words or forward-looking nature identify other comparable terminology. We have based these forward-looking statements for purposes on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of the federal securities laws or otherwiseoperations, strategy, short- and long-term business operations and objectives, and financial needs. All These forward-looking statements involve inherent risks are subject to a number of risks, uncertainties and uncertaintiesassumptions. Moreover, we operate in a very competitive and rapidly changing environment, and there are or will be important factors that could cause actual results new risks emerge from time to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectustime. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this prospectus may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward- forward-looking statements. You should Forward-looking statements include, but are not assume that limited to, statements about: ● our ability to obtain funding for our future clinical trials, preclinical activities and our operations; ● our ability to obtain and maintain regulatory approval of our product candidates; ● our ability to contract with third-party suppliers, manufacturers and other service providers and their ability to perform adequately; ● our ability to meet obligations under our license agreements; ● the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplementpotential market size, opportunity and growth potential for our product candidates, if approved; ● our ability to build our own sales and marketing capabilities, or that any information incorporated by reference into this prospectus supplement is accurate as seek collaborative partners, to commercialize our product candidates, if approved; ● our ability to retain the continued service of any date other than our key professionals and to identify, hire and retain additional qualified professionals; ● our ability to advance product candidates into, and successfully complete, clinical trials; ● our ability to recruit and enroll suitable patients in our clinical trials; ● the date initiation, timing, progress and results of clinical trials and pre-clinical studies for our drug candidates; ● the timing or likelihood of the document so incorporated accomplishment of various scientific, clinical, regulatory filings and approvals and other product development objectives; ● the pricing and reimbursement of our product candidates, if approved; ● the rate and degree of market acceptance of our product candidates by referencephysicians, patients, third-party payors and others in the medical community, if approved; ● the implementation of our business model, strategic plans for our business, product candidates and technology; ● the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; ● developments relating to our competitors and our industry; ● the accuracy of our estimates regarding expenses, capital requirements and needs for additional financing; and ● our financial performance. Except Forward-looking statements reflect our management’s expectations or predictions of future conditions, events or results based on various assumptions and management’s estimates of trends and economic factors in the markets in which we are active, as required by lawwell as our business plans. They are not guarantees of future performance. By their nature, we assume no obligation to update these forward-looking statements publicly, or are subject to update the reasons risks and uncertainties. Our actual results could differ materially and financial condition may differ, possibly materially, from those the anticipated results and financial condition indicated in these forward-looking statements. There are a number of factors that could cause actual conditions, even if new information becomes available events or results to differ materially from those described in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to contained in this prospectus and the documents incorporated by reference into this prospectus. See an additional discussion under “Risk Factors” in any applicable prospectus supplement and any related free writing prospectus, and in our most recent Annual Report on Form 10-K and any subsequently filed quarterly reports on Form 10-Q. These forward-looking statements are representative only as of the accompanying base prospectus that could cause actual results date they are made, and we undertake no obligation to differupdate any forward-looking statement as a result of new information, future events or otherwise.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and Agreement contains statements, which, to the accompanying base prospectus and the documents we file with the SEC extent that are incorporated by reference herein and therein contain “they do not recite historical facts, constitute forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect can be identified by the fact that they do not relate strictly to us, specifically, historical or current facts and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that may include the words “may,” “will,” “could,” “should,” “would,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and or other words or expressions of similar statements of a future or forward-looking nature identify meaning. These forward-looking statements for purposes are based on the current expectations of the federal securities laws or otherwiseCompany about future events. All The forward looking statements include statements that reflect the Company’s beliefs, plans, objectives, goals, expectations, anticipations and intentions with respect to the use of proceeds of the sale of BIF Units, intentions with respect to realization of proceeds from investments by the Company, potential redemptions and buybacks of BIF Units, distribution policy, expectations about development of the Brillouin technology, and statements about expected future performance and business of the Company and expected effect of U.S. regulations. The Company urges you to carefully review this Agreement, particularly Section 10 (“Risk Factors”) of this Agreement, for a more complete discussion of the risks of an acquisition of BIF Units. Although the Company believes that the expectations reflected in the forward-looking statements involve inherent risks and uncertaintiesare reasonable, the Company cannot guarantee the level of activity, performance or achievements, and there whether any BIF Units will be redeemed and the redemption price of any redemption. Many factors discussed in this Agreement, some of which are or beyond the Company’s control, will be important factors that could cause in determining the future performance of the Company. Consequently, actual results to may differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our might be anticipated from forward-looking statements in statements. In light of those risks as these and other uncertainties, you read this prospectus supplement and should not regard the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact inclusion of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any a forward-looking statements we may make. Given these uncertaintiesstatement in this Agreement as a representation by the Company that its plans and objectives will be achieved, and you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove The Company does not undertake any obligation to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral update any forward-looking statements attributable statements, whether as a result of new information, future events or otherwise, except as required by law. This Agreement is furnished for the purpose of providing certain information to us or individuals acting on our behalf are expressly qualified Investors. This Agreement is to be used by the person to whom it has been delivered solely in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all connection with the consideration of the factors set forth purchase of the BIF Units described herein. All recipients agree that they will use this Agreement for the sole purpose of evaluating a possible purchase of BIF Units. Acceptance of this Agreement by Investors constitutes an agreement to be bound by the terms herein. BIF Units have not been approved or referred disapproved by the U.S. Securities and Exchange Commission (the “SEC”) or by the securities regulatory authority of any state or of any other jurisdiction, nor has the SEC or any such securities regulatory authority passed upon the accuracy or adequacy of this Agreement. Any representation to the contrary is a criminal offense in the United States. In making a purchase decision, Investors must rely on their own examination of BIF Units, the Company, and terms of the private placement, including the merits and risks involved. Prospective Investors should not construe the contents of this Agreement as legal, business, tax, accounting, investment, financial, or other advice. Each prospective Investor is urged to consult its own advisers as to legal, business, tax, regulatory, accounting, financial and other consequences of its investment in BIF Units. No person has been authorized in connection with the Unit Sale to give any information or make any representations other than as contained in this Agreement. Any representation or information not contained herein must not be relied upon as having been authorized by the Company or any of its officers, employees, affiliates, or agents. While such information is believed to be reliable for the purpose used herein, neither the Company nor any of its officers, employees, affiliates, or agents assumes any responsibility for the accuracy of such information. The delivery of this Agreement does not imply that the information herein is correct as of any time subsequent to the date of this Agreement. This Agreement is not a prospectus supplement and does not purport to contain all information Investor may require. It is not intended to be relied upon solely in relation to, and must not be taken solely as the accompanying base prospectus basis for, a purchase decision. Prospective Investors outside the United States should inform themselves as to the legal requirements and tax consequences within the countries of their citizenship, residence, domicile and place of business with respect to the acquisition, holding or disposal of BIF Units, and any foreign exchange restrictions that could cause actual results to differmay be relevant thereto. The distribution of this Agreement and the offer and sale of BIF Units in certain jurisdictions may be restricted by law. PROSPECTIVE INVESTORS SHOULD BEAR IN MIND THAT PAST OR PROJECTED PERFORMANCE IS NOT NECESSARILY INDICATIVE OF FUTURE RESULTS, AND THERE CAN BE NO ASSURANCE THAT THE COMPANY WILL ACHIEVE COMPARABLE RESULTS OR THAT TARGETED RETURNS WILL BE MET. LOSSES MAY OCCUR.
Appears in 1 contract
Samples: Confidential Unit Sale Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are incorporated by reference herein and therein contain “includes forward-looking statements” statements within the meaning of Section 27A of the Securities Act of 1933, as amended, which we refer to as the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (amended, which we refer to as the “Exchange Act”), these statements reflect our current views with respect that relate to future events or to our ongoing and planned clinical trials, business strategy, business plan, future operations or financial performance and other future eventsperformance. These statements include Any forward-looking statement involves known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statement. Forward-looking statements both with respect include statements, other than statements of historical fact, about: ● our plans to us, specifically, and further develop our FullMAX system of wireless base stations; ● our plans to further develop remote radios; ● the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions adoption by our target industries of the Private Securities Litigation Reform Act new IEEE 802.16s standard for private cellular networks; ● our future development priorities; ● our estimates regarding the size of 1995our potential target markets; ● our expectations about the impact of new accounting standards; ● our future operations, financial position, revenues, costs, expenses, uses of cash, capital requirements, our need for additional financing or the period for which our existing cash resources will be sufficient to meet our operating requirements; ● our plans to list our common stock on the Nasdaq and whether an active trading market for our common stock will develop; and ● our strategies, prospects, plans, expectations, forecasts or objectives. Statements that include the words Words such as, but not limited to, “believe,” “expect,” “anticipate,” “estimate,” “forecast,” “intend,” “may,” “plan,” “believepotential,” “predict,” “project,” “estimatetargets,” “maylikely,” “will,” “would,” “could,” “should,” “anticipatecontinue,” “willscheduled” and similar statements expressions or phrases, or the negative of a future those expressions or forward-looking nature phrases, are intended to identify forward-looking statements for purposes of the federal securities laws or otherwise. All statements, although not all forward-looking statements involve inherent contain these identifying words. Although we believe that we have a reasonable basis for each forward- looking statement contained in this registration statement, we caution you that these statements are based on our estimates or projections of the future that are subject to known and unknown risks and uncertainties, uncertainties and there are or will be other important factors that could may cause our actual results results, level of activity, performance, experience or achievements to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our expressed or implied by any forward-looking statements in light statement. Actual results, level of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risksactivity, nor can we assess the impact of all factors on our business performance, experience or the extent to which any factor, or combination of factors, achievements may cause actual results to differ materially from those contained in expressed or implied by any forward-looking statements we may make. Given these uncertaintiesstatement as a result of various important factors, you should not place undue reliance including our critical accounting policies and risks and uncertainties relating, to: ● our ability to obtain additional financing on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplementreasonable terms, or that at all; ● our ability to repay our indebtedness; ● the accuracy of our estimates regarding expenses, costs, future revenues, uses of cash and capital requirements; ● any information incorporated by reference into this prospectus supplement is accurate as outbreak or worsening of any date other than the date an outbreak of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publiclycontagious diseases, or other adverse public health developments, could have a material and adverse effect on our business operations, financial condition and results of operations; ● the market acceptance of our wireless connection products and the IEEE 802.16s standard; ● our ability to update develop future generations of our current products; ● our ability to generate significant revenues and achieve profitability; ● our ability to successfully commercialize our current and future products, including their rate and degree of market acceptance; ● our ability to attract and retain key scientific or management personnel and to expand our management team; ● our ability to establish licensing, collaboration or similar arrangements on favorable terms and our ability to attract collaborators with development, regulatory and commercialization expertise; ● our ability to manage the reasons actual results could differ materially from those anticipated growth of our business; ● expenditures not resulting in these forwardcommercially successful products; ● our outreach to global markets; ● our commercialization, marketing and manufacturing capabilities and strategy; ● our ability to expand, protect and maintain our intellectual property position; ● the success of competing third-looking statements, even if new information becomes available party products; ● our ability to fully remediate our identified internal control material weaknesses; ● regulatory developments in the future. ThusUnited States and other countries; and ● our ability to comply with regulatory requirements relating to our business, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more and the costs of these or other risks or uncertainties materializescompliance with those requirements, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written including those on data privacy and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differsecurity.
Appears in 1 contract
Samples: Equity Distribution Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and supplement, the accompanying base prospectus and the other documents we file have filed with the SEC that are incorporated herein by reference herein and therein reference, contain “forward-looking statements” statements within the meaning of Section 27A of the Securities Act, Act and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing that involve substantial risks and planned clinical trialsuncertainties. In some cases, business strategy, business plan, financial performance and other future events. These statements include you can identify forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “believeobjective,” “projectanticipate,” “believe,” “estimate,” “maypredict,” “shouldpotential,” “anticipatecontinue” and “ongoing,” “will” or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and similar statements unknown risks, uncertainties and other important factors that may cause our actual results, levels of a future activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking nature identify statements. The forward-looking statements for purposes contained in this prospectus supplement, the accompanying prospectus and the documents incorporated by reference into this prospectus supplement and the accompanying prospectus are based upon information available to us as of the federal securities laws date of this prospectus supplement and, while we believe such information forms a reasonable basis for such statements, such information may be limited or otherwiseincomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. All forwardForward-looking statements involve inherent risks contained in this prospectus supplement, the accompanying prospectus and uncertainties, the information incorporated by reference herein and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors therein include, but are not limited to, those statements about: • the impact of the COVID-19 pandemic on our operations, research and development and clinical trials and potential disruption in the operations and business of third-party manufacturers, contract research organizations, other service providers and collaborators with whom we conduct business; • the development of our product candidates, including statements regarding the timing of initiation, completion and the outcome of clinical studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs; • our ability to advance our product candidates into, and successfully complete, clinical trials; • our ability to obtain and maintain regulatory approval of our product candidates in the indications for which we plan to develop them, and any related restrictions, limitations or warnings in the label of an approved drug or therapy; • our ability to license additional intellectual property relating to our product candidates from third parties and to comply with our existing license agreement; • our plans to research, develop, manufacture and commercialize our product candidates; • the timing of our regulatory filings for our product candidates, along with regulatory developments in the United States, European Union and other foreign countries; • the size and growth potential of the markets for our product candidates, if approved, and the rate and degree of market acceptance of our product candidates, including reimbursement that may be received from payors; • our ability to raise additional capital; • our commercialization, marketing and manufacturing capabilities and strategy; • our expectations regarding our ability to obtain and maintain intellectual property protection; • our ability to attract and retain qualified employees and key personnel; • our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; • the scalability and commercial viability of our manufacturing methods and processes; • the success of competing therapies that are or may become available; • whether we are classified as a PFIC for current and future periods; • our estimates regarding future expenses, revenues and needs for additional financing and the accuracy thereof; and • our expected use of proceeds from this offering. You should refer to the important factors set forth under in the caption “Risk Factors” cautionary statements included in this prospectus supplement supplement, the accompanying prospectus and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis other documents incorporated by reference herein, for a discussion of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all important factors on our business or the extent to which any factor, or combination of factors, that may cause our actual results to differ materially from those contained in any expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplementwill prove to be accurate. Furthermore, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these if our forward-looking statements publiclyprove to be inaccurate, or to update the reasons actual results could differ materially from those anticipated inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume regard these statements as a representation or warranty by us or any other person that we will achieve our silence over objectives and plans in any specified time means that actual events are bearing out as expressed frame, or implied in such at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. If one or more of these or other risks or uncertainties materializesYou should read this prospectus supplement, or if our underlying assumptions prove to be incorrectthe accompanying prospectus, actual results and any free writing prospectuses that we may vary materially from what authorize for use in connection with an offering and the documents that we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to reference in this prospectus supplement and in the accompanying base prospectus and have filed as exhibits to the registration statement of which this prospectus supplement is a part completely and with the understanding that could cause our actual future results to differmay be materially different from what we expect.
Appears in 1 contract
Samples: Open Market Sale Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are incorporated by reference herein and therein into this prospectus contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forwardForward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the can be identified by words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” “project,” “estimategoal,” “strategy,” “future,” “likely,” “may,” “should,” “anticipate,” “will” and variations of these words and similar statements of a references to future or forward-looking nature identify periods, although not all forward-looking statements for purposes contain these identifying words. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the federal securities laws or otherwisefuture of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. All Because forward-looking statements involve relate to the future, they are subject to inherent risks and risks, uncertainties, and there are changes in circumstances, including but not limited to risk factors contained in or will be important factors that could cause incorporated by reference under the section titled, “Risk Factors.” As a result, our actual results to may differ materially from those indicated expressed or forecasted in these the forward-looking statements, and you should not rely on such forward-looking statements. You should carefully read this prospectus and any applicable supplement to this prospectus, together with the information incorporated herein by reference as described under the section titled “Where You Can Find More Information,” completely and with the understanding that our actual future results may be materially different from what we expect. We believe can give no assurances that these factors any of the events anticipated by the forward-looking statements will occur or, if any of them do, what impact they will have on our results of operations and financial condition. Forward-looking statements include, but are not limited to, those factors set forth under statements about: • our lack of significant revenue to date, our history of recurring operating losses and our expectation of future operating losses; • our need for substantial additional capital and our need to delay, reduce or eliminate our drug development and commercialization efforts if we are unable to raise additional capital; • the caption “Risk Factors” in this prospectus supplement highly-competitive nature of the pharmaceutical and in biotechnology industry and our ability to compete effectively; • the accompanying base prospectus success of our plans to use collaboration arrangements to leverage our capabilities; • our ability to retain and under attract key personnel; • the captions “Risk Factors,” “Business,” risk of misconduct of our employees, agents, consultants and “Management’s Discussion commercial partners; • disruptions to our operations due to expansions of our operations; • the costs we would incur if we acquire or license technologies, resources or drug candidates; • risks associated with product liability claims; • our reliance on information technology systems and Analysis the liability or interruption associated with cyber-attacks or other breaches of Financial Condition and Results of Operations,” our systems; • our ability to use net operating loss carryforwards; • provisions in our most recent Annual Report charter documents and state law that may prevent a change in control; • work slowdown or stoppage at government agencies could negatively impact our business • our need to complete extensive clinical trials and the risk that we may not be able to demonstrate the safety and efficacy of our drug candidates; • risks that that our clinical trials may be delayed or terminated; • our ability to obtain domestic and foreign regulatory approval for our drug candidates; • changes in existing laws and regulations affecting the healthcare industry; • our reliance on Form 10third parties to conduct clinical trials for our drug candidates; • our ability to maintain orphan drug exclusivity for our drug candidates; • our reliance on third parties for manufacturing our clinical drug supplies; • risks associated with the manufacture of our drug candidates; • our ability to establish sales and marketing capabilities relating to our drug candidates; • market acceptance of our drug candidates; • third-K party payor reimbursement practices; • our ability to adequately protect the intellectual property of our drug candidates; • infringement on the intellectual property rights of third parties; • costs and time relating to litigation regarding intellectual property rights; • our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all ability to adequately prevent disclosure by our employees or others of which you should review carefullytrade secrets and other proprietary information; • the volatility of the trading price of our common stock; • our common stock being thinly traded; • our ability to issue shares of common or preferred stock without approval from our stockholders; • our ability to pay cash dividends; • costs and expenses associated with being a public company; • a material weakness identified in our internal controls over financial reporting; and • our ability to maintain compliance with the listing standards of the Nasdaq Capital Market. Please consider our Any forward-looking statements statement made by us in light of those risks as you read this prospectus, any applicable supplement to this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information documents incorporated by reference into this prospectus supplement is accurate based only on information currently available to us and speaks only as of any date other than the date of the document so incorporated by referenceon which it is made. Except as required by law, we assume We undertake no obligation to publicly update these any forward-looking statements publiclystatement, whether as a result of new information, future developments or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the futureotherwise. ThusHowever, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of review the risk factors set forth in other reports or referred documents we file from time to in this prospectus supplement and in time with the accompanying base prospectus that could cause actual results to differSEC.
Appears in 1 contract
Samples: At the Market Offering Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement includes and the accompanying base prospectus and the documents we file with the SEC that are incorporated incorporates by reference herein and therein contain “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and releases issued by the SEC and within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include you can identify forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words by terminology such as “aim,” “anticipate,” “assume,” “believe,” “continue,” “could,” “due,” “estimate,” “expect,” “intend,” “may,” “objective,” “plan,” “believepredict,” “projectpotential,” “estimatepositioned,” “mayseek,” “should,” “anticipatetarget,” “will,” “would” and other similar statements expressions that are predictions of a or indicate future events and future trends, or forward-looking nature identify forward-the negative of these terms or similar language. Forward- looking statements for purposes of the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, statements about: • our expectations regarding the timing, progress and results clinical trials for TPST-1495 and TPST-1120 and preclinical studies for TREX-1 and any other product candidates we develop, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs; • the timing or likelihood of regulatory filings for TPST-1495, TPST-1120 and TREX-1 and any other product candidates we develop and our ability to obtain and maintain regulatory approvals for such product candidates for any indication; • our manufacturing capabilities and strategy, including the scalability of our manufacturing methods and processes; • our expectations regarding the potential benefits, activity, effectiveness and safety of TPST-1495, TPST-1120 and TREX-1 and any other product candidates we develop; • our intentions and ability to successfully commercialize our product candidates; • our estimates regarding our expenses, future revenues, capital requirements, our needs for or ability to obtain additional financing and the period over which we expect our current cash, cash equivalents and marketable securities to be sufficient to fund our operations; • our intended reliance on and the performance of third parties, including collaborators, contract research organizations and third-party manufacturers; • our ability to protect and enforce our intellectual property protection and the scope and duration of such protection; • developments and projections relating to our competitors and our industry, including competing therapies; • the introduction of technological innovations or new therapies that compete with our products and services; • the impact of the COVID-19 pandemic on the initiation (including the emergence of variant strains), progress or expected timing of our clinical trials and the timing of related data, our efforts to adjust trial-related activities to address the impact of the COVID-19 pandemic, and other future impacts of the COVID-19 pandemic on the economy, our industry and our financial condition and results of operations; • the impact of current and future laws and regulations; and • our intended use of proceeds from this offering. These statements are based on management’s current expectations, estimates, forecasts and projections about our business and industry, are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control, such as the impacts of the COVID-19 pandemic, and that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those factors set forth under anticipated by the caption forward-looking statements. We discuss many of these risks in greater detail in the section entitled “Risk Factors” and elsewhere in this prospectus supplement. You should read these factors and the other cautionary statements made in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, as being applicable to all of which you should review carefully. Please consider our related forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business wherever they appear herein or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statementstherein. If one or more of these or other risks or uncertainties materializesfactors materialize, or if our any underlying assumptions prove to be incorrect, our actual results results, levels of activity, performance, or achievements may vary materially from what we anticipateany future results, activity, performance, or achievements expressed or implied by these forward-looking statements. All subsequent written and oral We caution readers not to place undue reliance on any forward-looking statements attributable made by us, which speak only as of the date they were made. We undertake no obligation to us publicly update any forward- looking statements after the date of this prospectus supplement, whether as a result of new information, future events or individuals acting on otherwise, except as required by law. You should read this prospectus supplement together with the accompanying prospectus and documents we have filed with the SEC that are incorporated by reference and any free writing prospectus that we may authorize for use in connection with this offering completely and with the understanding that our behalf are expressly qualified in their entirety by this Noteactual future results may be materially different from what we expect. Before purchasing any shares of common stock, you should consider carefully We qualify all of the factors set forth or referred to in this prospectus supplement and forward-looking statements in the accompanying base prospectus that could cause actual results to differforegoing documents by these cautionary statements.
Appears in 1 contract
Samples: Open Market Sale Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are incorporated by reference herein and therein contain “in this prospectus include forward-looking statements” statements within the meaning of Section 27A of the Securities Act, Act and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect that relate to future events or to our ongoing and planned clinical trials, business strategy, business plan, future operations or financial performance and other future eventsperformance. These statements include Any forward-looking statements both with respect statement involves known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to usdiffer materially from any future results, specificallylevels of activity, and the biotechnology sectorperformance or achievements expressed or implied by such forward-looking statement. Words such as, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words but not limited to, “believe,” “expect,” “anticipate,” “estimate,” “intend,” “may,” “plan,” “believepotential,” “predict,” “project,” “estimatetargets,” “maylikely,” “will,” “would,” “could,” “should,” “anticipatecontinue,” “willscheduled,” and similar statements expressions or phrases, or the negative of a future those expressions or forward-looking nature phrases, are intended to identify forward-looking statements for purposes of the federal securities laws or otherwise. All statements, although not all forward-looking statements involve inherent contain these identifying words. Although we believe that we have a reasonable basis for each forward-looking statement contained or incorporated by reference in this prospectus, we caution you that these statements are based on our projections of the future that are subject to known and unknown risks and uncertainties, uncertainties and there are or will be other important factors that could may cause our actual results results, level of activity, performance or achievements expressed or implied by any forward-looking statement to differ materially from those indicated expressed or implied by any forward-looking statement. The sections in these statements. We believe that these factors includeour periodic reports, but are not limited toincluding our Annual Report on Form 10-K for the fiscal year ended December 31, those factors set forth under the caption 2018, entitled “Business,” “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” as well as other sections in this prospectus and the documents or reports incorporated by reference in this prospectus, discuss some of the factors that could contribute to these differences. These forward-looking statements include, among other things, statements about: • the accuracy of our most recent Annual Report on Form 10-K estimates regarding expenses, future revenues, uses of cash, cash equivalents and investment securities, capital requirements and the need for additional financing; • the initiation, cost, timing, progress and results of our development activities, preclinical studies and clinical trials; • the timing of and our subsequent Quarterly Reports ability to obtain and maintain regulatory approval, or submit an application for regulatory approval, of our existing product candidates, any product candidates that we may develop, and any related restrictions, limitations, and/or warnings in the label of any approved product candidates; • our plans to research, develop and commercialize our current and future product candidates; • our collaborators’ election to pursue research, development and commercialization activities; • our ability to obtain future reimbursement and/or milestone payments from our collaborators; • our ability to attract collaborators with development, regulatory and commercialization expertise; • our ability to obtain and maintain intellectual property protection for our product candidates; • our ability to successfully commercialize our product candidates; • the size and growth of the markets for our product candidates and our ability to serve those markets; • the rate and degree of market acceptance of any future products; • the success of competing drugs that are or become available; • regulatory developments in the United States and other countries; • the performance of our third-party suppliers and manufacturers and our ability to obtain alternative sources of raw materials; • our ability to obtain additional financing; • our use of the proceeds from our securities offerings; • any restrictions on Form 10-Q/10-Q/Aour ability to use our net operating loss carryforwards; • our exposure to investment risk, all of which you should review carefullyinterest rate risk and capital market risk; and • our ability to attract and retain key scientific or management personnel. Please consider We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements in light of those risks as you read this prospectus supplement statements, and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- our forward-looking statements. You should not assume Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important cautionary statements in this prospectus or in the documents incorporated by reference in this prospectus, particularly in the “Risk Factors” section, that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. For a summary of such factors, please refer to the section entitled “Risk Factors” in this prospectus, as updated and supplemented by the discussion of risks and uncertainties under “Risk Factors” contained in any supplements to this prospectus and in our most recent annual report on Form 10-K, as revised or supplemented by our subsequent quarterly reports on Form 10-Q or current reports on Form 8-K, as well as any amendments thereto, as filed with the SEC and which are incorporated herein by reference. The information contained in this prospectus supplement document is accurate believed to be current as of any date other than the date of this document. We do not intend to update any of the forward-looking statements after the date of this document to conform these statements to actual results or to changes in our expectations, except as required by law. In light of these assumptions, risks and uncertainties, the results and events discussed in the forward-looking statements contained in this prospectus or in any document incorporated herein by reference might not occur. Investors are cautioned not to place undue reliance on the front forward- looking statements, which speak only as of the date of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by referencereference in this prospectus. Except as required by lawWe are not under any obligation, and we assume no obligation expressly disclaim any obligation, to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these alter any forward-looking statements, even if whether as a result of new information becomes available in the future. Thusinformation, you should not assume that our silence over time means that actual future events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipateotherwise. All subsequent written and oral forward-looking statements attributable to us or individuals to any person acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth cautionary statements contained or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differsection.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus, including the documents that we incorporate by reference herein, contains, and any applicable prospectus supplement and the accompanying base or free writing prospectus and including the documents we file with the SEC that are incorporated incorporate by reference herein and therein contain “forward-looking statements” within the meaning of Section 27A of the Securities Actmay contain, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, that involve substantial risks and the biotechnology sector, in general. We make these statements pursuant to uncertainties for purposes of the safe harbor provisions of provided by the Private Securities Litigation Reform Act of 1995. Statements that include All statements contained in this prospectus and the documents referenced above, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. The words “expectbelieve,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” “believeexpect,” “projectpredict,” “estimatepotential,” “mayopportunity,” “goals,” or “should,” “anticipate,” “will” and similar expressions are intended to identify forward- looking statements. Such statements of a future or forward-looking nature identify are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, statements relating to: • our future research and development activities, including clinical testing and the costs and timing thereof; • our strategy, including clinical development of cobomarsen, our regulatory and clinical strategies for purposes cobomarsen, remlarsen, MRG-229 and other product candidates, and the clinical and commercial potential of our product candidates, if approved; • sufficiency of our cash resources; • our ability to raise additional funding when needed; • any statements concerning anticipated regulatory activities or licensing or collaborative arrangements; • our research and development and other expenses; • our operations and legal risks; • our ability to maintain listing on a national securities exchange; • any statement of assumptions underlying any of the federal securities laws or otherwiseforegoing. All We have based these forward-looking statements involve inherent risks largely on our current expectations and uncertaintiesprojections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and there financial needs. These forward- looking statements are or will be important factors that could cause actual results subject to differ materially from a number of risks, uncertainties and assumptions, including those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth described above under the caption heading “Risk Factors.” Moreover, we operate in this prospectus supplement a very competitive and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefullyrapidly changing environment. Please consider our forward-looking statements in light of those New risks as you read this prospectus supplement and the accompanying base prospectusemerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given In light of these uncertaintiesrisks, you should not place undue reliance on these forward- looking statements. You should not assume that uncertainties and assumptions, the information contained future events and trends discussed in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. We undertake no obligation to revise or publicly release the results of any revision to these forward-looking statements, even if new information becomes available in the futureexcept as required by law. ThusGiven these risks and uncertainties, you should readers are cautioned not assume that our silence over time means that actual events are bearing out as expressed or implied in to place undue reliance on such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differcautionary statement.
Appears in 1 contract
Samples: Open Market Sale Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and prospectus, the documents we file with the SEC that are incorporated by reference herein and therein any accompanying prospectus supplement may contain “forward-looking statements” within . These statements relate to future events or our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. All statements other than statements of historical facts are forward-looking statements. These forward- looking statements are made under the meaning of safe harbor provision under Section 27A of the Securities Act, Act and Section 21E of the Securities Exchange Act of 1934, and as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology sector, defined in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words “expect,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or forward-looking nature In some cases, you can identify forward-looking statements for purposes by terminology such as may, will, should, expects, intends, plans, anticipates, believes, estimates, predicts, potential, continue or the negative of the federal securities laws these terms or otherwiseother comparable terminology. All These statements are only predictions. You should not place undue reliance on forward-looking statements because they involve inherent risks known and uncertaintiesunknown risks, uncertainties and other factors, which are, in some cases, beyond our control and which could materially affect results. You should refer to the Risk Factors section of this prospectus, any accompanying prospectus supplement, and there are or will be important factors our periodic and current reports filed with the SEC for specific risks that could cause actual results to differ materially be significantly different from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such by these forward-looking statements. If one or more of these or other risks or uncertainties materializesoccur, or if our underlying assumptions prove to be incorrect, actual events or results may vary significantly from those implied or projected by the forward-looking statements. No forward- looking statement is a guarantee of future performance. Forward-looking statements speak only as of the date made and we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You should read this prospectus, any accompanying prospectus supplement and the documents that we reference in this prospectus and have filed with the SEC as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what any future results expressed or implied by these forward-looking statements. Forward-looking statements in this prospectus include, but are not limited to, statements about: • the initiation, timing, progress and results of our studies in animals and clinical trials, and our research and development programs; • our ability to advance our product candidates into, and successfully complete, clinical trials; • our reliance on the success of our clinical-stage product candidates; • the timing or likelihood of regulatory filings and approvals; • the commercialization of our product candidates, if approved; • our ability to develop sales and marketing capabilities; • the pricing and reimbursement of our product candidates, if approved; • the implementation of our business model, strategic plans for our business and technology; • the scope of protection we anticipate. All subsequent written are able to establish and oral maintain for intellectual property rights covering our product candidates and technology; • our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; • costs associated with defending intellectual property infringement, product liability and other claims; • regulatory development in the United States, China and other jurisdictions; • estimates of our expenses, future revenues, capital requirements and our needs for additional financing; • the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements; • our ability to maintain and establish collaborations or obtain additional grant funding; • the rate and degree of market acceptance of our product candidates; • developments relating to our competitors and our industry, including competing therapies; • our ability to effectively manage our anticipated growth; • our ability to attract and retain qualified employees and key personnel; • statements regarding future revenue, hiring plans, expenses, capital expenditures, capital requirements and share performance; • the future trading price of our ordinary shares and impact of securities analysts’ reports on these prices; and • other risks and uncertainties, including those listed under the caption Risk Factors. The Risk Factors section of this prospectus references the principal contingencies and uncertainties to which we believe we are subject, which should be considered in evaluating any forward-looking statements attributable to us contained or individuals acting on our behalf are expressly qualified in their entirety incorporated by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to reference in this prospectus supplement and or in the accompanying base any prospectus that could cause actual results to differsupplement.
Appears in 1 contract
Samples: Open Market Sale Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and prospectus, including the documents that we file with the SEC that are incorporated incorporate by reference herein and therein contain “herein, may contain, forward-looking statements” statements within the meaning of Section 27A of the Securities Act, Act and Section 21E of the Securities Exchange Act of 1934, as amended (“the “Exchange Act”), these including statements reflect regarding our current views with respect to our ongoing and planned clinical trialsfuture financial condition, business strategy, business plan, financial performance strategy and other plans and objectives of management for future eventsoperations. These Forward-looking statements include all statements that are not historical facts. In some cases, you can identify forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words by terminology such as “expectbelieve,” “will,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “believemight,” “projectapproximately,” “estimateexpect,” “maypredict,” “shouldcould,” “anticipate,potentially” “will” and or the negative of these terms or other similar statements of a future or forwardexpressions. Forward-looking nature identify statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Discussions containing these forward-looking statements for purposes of may be found, among other places, in the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption sections entitled “Business,” “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” contained in the documents incorporated by reference in this prospectus, including our most recent Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q, as well as any amendments thereto. These statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that could cause our actual results, levels of activity, performance or achievement to differ materially from those expressed or implied by these forward-looking statements. We discuss in greater detail, and incorporate by reference into this prospectus in their entirety, many of these risks and uncertainties under the section entitled “Risk Factors” included in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of as well as any amendments thereto, filed with the SEC, which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information are incorporated by reference into this prospectus. Additional factors are discussed under the section entitled “Risk Factors” in this prospectus supplement is accurate as of and any date free writing prospectus and under similar headings in the other than the date of the document so documents that are incorporated by referencereference into this prospectus. Except as required by lawThese statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. New risks and uncertainties arise from time to time, we assume and it is impossible for us to predict these events or how they may affect us. We undertake no obligation to update these forward-looking statements publicly, revise or publicly release the results of any revision to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the futureexcept as required by law. ThusGiven these risks and uncertainties, you should readers are cautioned not assume that our silence over time means that actual events are bearing out as expressed or implied in to place undue reliance on such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Notecautionary statement. Before purchasing any shares Data Storage Corporation, a Nevada corporation (“Data Storage,” “the Company,” “we,” “us,” and “our”), is headquartered in Melville, New York. We leverage our expertise through our two subsidiaries: CloudFirst Technologies Corporation, a Delaware corporation (“CloudFirst Technologies”), and Nexxis Inc., a Nevada corporation (“Nexxis”). Through these subsidiaries, we provide solutions and services to a broad range of common stockclients in various industries, you should consider carefully all including healthcare, banking and finance, distribution services, manufacturing, construction, education, and government. Our subsidiaries maintain robust business development teams and independent distribution channels. In response to a capital raise and Nasdaq uplisting in 2021, we expanded our distribution networks and bolstered our team, focusing on enhancing our sales, marketing, and technological capabilities. We operate in six geographically diverse data centers across the U.S. and Canada, supporting our commitment to providing secure and reliable subscription-based services. Recognizing the urgent need for reliable and efficient IT solutions, we aim to tap into the growing demand for managed cloud and cybersecurity services. CloudFirst Technologies is positioned to capture a significant share of management’s estimate of the factors set forth or referred to in this prospectus supplement and $36 billion annual recurring revenue market in the accompanying base prospectus U.S. and Canada. Our IBM platform, with assets deployed in six data centers, aligns with IBM’s estimate that could cause actual results 10% of workloads will migrate to differcloud-based solutions annually. Our offerings are designed to support a spectrum of needs, from cloud-based IBM Power System deployments for critical workloads to comprehensive disaster recovery and cybersecurity protections. Our focus on hybrid cloud deployments ensures that data and workloads remain secure against various threats.
Appears in 1 contract
Samples: Equity Distribution Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file incorporated by reference contain forward-looking statements. These are based on our management’s current beliefs, expectations and assumptions about future events, conditions and results and on information currently available to us. Discussions containing these forward- looking statements may be found, among other places, in the sections titled “Information on the Company,” “Risk Factors” and “Operating and Financial Review and Prospects” incorporated by reference from our most recent Annual Report on Form 20-F, as well as any amendments thereto, filed with the SEC SEC. All statements other than present and historical facts and conditions contained in this prospectus or incorporated herein, including statements regarding our future results of operations and financial position, business strategy, plans and our objectives for future operations, are forward-looking statements. When used in this prospectus, the words “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “is designed to,” “may,” “might,” “plan,” “potential,” “predict,” “objective,” “should,” or the negative of these and similar expressions identify forward-looking statements. Forward-looking statements include, but are not limited to, statements about: • the prospects of attaining, maintaining and expanding marketing authorization for monalizumab, lacutamab and our other product candidates; • the initiation, timing, progress and results of our preclinical studies and clinical trials and those conducted by third parties, including our collaborator AstraZeneca; • our ability to successfully develop and advance our pipeline of product candidates; • the timing or likelihood of regulatory filings and approvals; • our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; • our commercialization of Lumoxiti, including the expected transitioning of commercialization activities in the United States from AstraZeneca to us commenced in mid-2019, and any of our product candidates, if approved, for which we retain commercialization rights; • future agreements with third parties in connection with the commercialization of our product candidates and any other approved product; • our ability to develop sales and marketing capabilities and transition into a commercial-stage company; • the pricing and reimbursement of Lumoxiti and our product candidates, if approved; • the effects of increased competition as well as innovations by new and existing competitors in our industry; • our ability to obtain funding for our operations; • our ability to obtain, maintain, protect and enforce our intellectual property rights and propriety technologies and to operate our business without infringing the intellectual property rights and proprietary technology of third parties; • regulatory developments in the United States, Europe and other countries; • costs of compliance and our failure to comply with new and existing governmental regulations including, but not limited to, tax regulations; • statements regarding future revenue, hiring plans, expenses, capital expenditures, capital requirements and stock performance; • our expected use of proceeds of the October 2019 global offering; • the impact of COVID-19 on our business, financial condition and results of operations; and • other risks and uncertainties, including those listed in the section of this prospectus titled “Risk Factors.” You should refer to the “Risk Factors” section contained in the applicable prospectus supplement and any related free writing prospectus, and under similar headings in the other documents that are incorporated by reference herein and therein contain “into this prospectus for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements” within . As a result of these factors, we cannot assure you that the meaning forward-looking statements in this prospectus will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame or at all. We undertake no obligation to publicly update any forward- looking statements, whether as a result of new information, future events or otherwise, except as required by law. The Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act, Act and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)amended, these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include do not protect any forward-looking statements both that we make in connection with respect to usthis prospectus. In addition, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words “expect,” “intend,” “plan,” “we believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or forward-looking nature identify forward-looking reflect our beliefs and opinions on the relevant subject. These statements for purposes are based upon information available to us as of the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertaintiesdate of this prospectus, and there while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are or will be important factors that could cause actual results inherently uncertain and investors are cautioned not to differ materially from those indicated in unduly rely upon these statements. We believe You should read this prospectus and the documents that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” we reference in this prospectus supplement and in have filed as exhibits to this prospectus completely and with the accompanying base prospectus understanding that our actual future results, levels of activity, performance and under the captions “Risk Factors,” “Business,” events and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, circumstances may be materially different from what we expect. We qualify all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given by these uncertainties, you should not place undue reliance on these forward- looking cautionary statements. You should not assume that the Unless otherwise indicated, information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement concerning our industry and the markets in which we operate, including our general expectations and market position, market opportunity and market size estimates, is accurate based on information from independent industry analysts, third-party sources and management estimates. Management estimates are derived from publicly available information released by independent industry analysts and third-party sources, as well as data from our internal research, and are based on assumptions made by us based on such data and our knowledge of any date other than the date of the document so incorporated by reference. Except as required by lawsuch industry and market, which we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove believe to be incorrectreasonable. In addition, actual results may vary materially from what while we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of believe the factors set forth or referred to market opportunity information included in this prospectus supplement or incorporated by reference is generally reliable and in is based on reasonable assumptions, such data involve risks and uncertainties and are subject to change based on various factors, including those discussed under the accompanying base prospectus that could cause actual results to differsection titled “Risk Factors.” of this prospectus.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement, the accompanying prospectus and the documents that we have filed with the Securities and Exchange Commission, or the SEC, that are incorporated by reference in this prospectus supplement and the accompanying base prospectus contain forward- looking statements about us and the documents we file with the SEC our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this prospectus supplement, including statements regarding our future results of operations or financial condition, business strategy and plans and objectives of management for future operations, are incorporated by reference herein and therein contain “forward-looking statements” within the meaning of Section 27A of the Securities Act. In some cases, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words “expect,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or forward-looking nature you can identify forward-looking statements for purposes because they contain words such as "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will" or "would" or the negative of the federal securities laws these words or otherwise. All other similar terms or expressions, although not all forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in contain these statementswords. We believe that these factors These forward-looking statements include, but are not limited to, those factors set forth under statements concerning the caption “Risk Factors” following: § the initiation, timing, progress and results of our research and development programs, preclinical studies, any clinical trials and Investigational New Drug, or IND, and other regulatory submissions; § our expectations regarding the activity of ATRC-101 or potential future product candidates once administered in a human subject; § our expectations and beliefs regarding the market for cancer therapies and development of the immuno-oncology industry; § our ability to identify and develop product candidates for treatment of additional disease indications; § our or a potential future collaborator's ability to obtain and maintain regulatory approval of any of our current or potential future product candidates; § the rate and degree of market acceptance of any approved product candidates; § the implementation of our business model and strategic plans for our business, technologies, and current or potential future product candidates; § our or any potential future collaborator's ability to obtain and maintain intellectual property protection for our discovery platform and current or potential future product candidates and our ability to operate our business without infringing the intellectual property rights of others; § our expectations regarding our ability to expand our pipeline through collaborations, the timing of our entry into additional collaborations and our ability to finalize the financial and operational details of our collaboration with BeiGene Ltd. and IGM Biosciences, Inc.; and § our use of the net proceeds from this offering. You should not rely on forward-looking statements as predictions of future events. We have based the forward-looking statements contained in this prospectus supplement and in the accompanying base prospectus primarily on our current expectations and under projections about future events and trends that we believe may affect our business, financial condition and operating results. The outcome of the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” events described in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our these forward-looking statements is subject to risks, uncertainties and other factors described in light of the section titled "Risk Factors" and elsewhere in this prospectus supplement and the accompanying prospectus. Moreover, we operate in a very competitive and rapidly changing environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this prospectus supplement and the accompanying prospectus. The results, events and circumstances reflected in the forward-looking statements may not be achieved or occur, and actual results, events or circumstances could differ materially from those risks as you described in the forward-looking statements. You should read this prospectus supplement and the accompanying base prospectusprospectus and the documents that we reference in this prospectus supplement and the accompanying prospectus and have filed as exhibits to the registration statement, of which this prospectus supplement is a part, that we have filed with the SEC with the understanding that our actual future results, levels of activity, performance and achievements may be materially different from what we expect. It is In addition, statements that "we believe" and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based on information available to us as of the date of this prospectus supplement. While we believe that information provides a reasonable basis for these statements, that information may be limited or incomplete. Our statements should not possible for our management be read to predict all risks, nor can indicate that we assess the impact of all factors on our business or the extent to which any factorhave conducted an exhaustive inquiry into, or combination review of, all relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely on these statements. The forward-looking statements made in this prospectus supplement relate only to events as of factors, may cause actual results the date on which the statements are made. We undertake no obligation to differ materially from those contained in update any forward-looking statements we made in this prospectus supplement to reflect events or circumstances after the date of this prospectus supplement or to reflect new information or the occurrence of unanticipated events, except as required by law. We may make. Given these uncertaintiesnot actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral Our forward-looking statements attributable do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments. We qualify all of our forward-looking statements by these cautionary statements. We currently intend to us use the net proceeds from this offering as follows: § to fund continued research and development of ATRC-101 and our other early-stage product candidates; § to fund investment in our discovery platform and business development activities; and § for working capital and general corporate purposes. The expected use of the net proceeds from this offering represents our intentions based upon our current plans and business conditions, which could change in the future as our plans and business conditions evolve. The amounts and timing of our actual expenditures depend on numerous factors, including the progress of our preclinical development efforts, the ongoing status of and results of our clinical trials and other studies and any unforeseen cash needs. As a result, our management will have broad discretion in the application of the net proceeds, and investors will be relying on the judgment of our management regarding the application of the net proceeds of this offering. Although we may use a portion of the net proceeds from the offering for the acquisition or individuals acting on our behalf are expressly qualified licensing, as the case may be, of product candidates, technologies, compounds, other assets or complementary businesses, we have no current understandings, agreements or commitments to do so. Pending these uses, we intend to invest the net proceeds from this offering in their entirety by this Noteinterest-bearing, investment-grade securities. Before purchasing any shares Our net tangible book value as of June 30, 2020 was approximately $154.1 million, or $5.47 per share of common stock. Net tangible book value per share is determined by dividing our total tangible assets, you should consider carefully less total liabilities, by the number of shares of our Class A common stock and Class B common stock outstanding as of June 30, 2020. Dilution with respect to net tangible book value per share represents the difference between the amount per share paid by purchasers of shares of our Class A common stock in this offering and the as adjusted net tangible book value per share of our Class A common stock and Class B common stock immediately after giving effect to this offering. After giving effect to the assumed sale of 7,251,631 shares of our Class A common stock in this offering at an offering price of $13.79 per share which was the last reported sale price of our Class A common stock on The Nasdaq Global Select Market on August 11, 2020, and after deducting commissions and estimated offering expenses payable by us, our as adjusted net tangible book value as of June 30, 2020 would have been approximately $250.9 million, or $7.08 per share. This would represent an immediate increase in net tangible book value of $1.61 per share to existing stockholders and immediate dilution of $6.71 in net tangible book value per share to investors purchasing our Class A common stock in this offering at the assumed public offering price. The following table illustrates this dilution on a per share basis. The as adjusted information is illustrative only and will change based on the actual price to the public, the actual number of shares sold and other terms of the offering determined at the time shares of our Class A common stock are sold pursuant to this prospectus supplement. The as adjusted information assumes that all of our common stock in the factors set forth or referred to aggregate amount of $100.0 million is sold at the assumed public offering price of $13.79 per share, the last reported sale price of our common stock on The Nasdaq Global Select Market on August 11, 2020. The shares sold in this prospectus supplement and offering, if any, will be sold from time to time at various prices. Assumed public offering price per share $ 13.79 Pro forma net tangible book value per share as of June 30, 2020 $ 5.47 Increase in net tangible book value per share attributable to the offering $ 1.61 As adjusted net tangible book value per share as of June 30, 2020 after giving effect to the offering $ 7.08 Dilution in net tangible book value per share to new investors in the accompanying base prospectus offering $ 6.71 The number of shares of our Class A common stock that could cause actual results to differ.will be outstanding after this offering is based on 22,258,542 shares of our Class A common stock and 5,934,191 shares of our Class B common stock outstanding as of June 30, 2020 and excludes: § 2,903,297 shares of Class A common stock issuable upon the exercise of stock options issued and outstanding as of June 30, 2020 under our 2010 Equity Incentive Plan, or 2010 Plan, with a weighted average exercise price of $8.42 per share;
Appears in 1 contract
Samples: Common Stock Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file with the SEC The statements contained in this information statement that are incorporated by reference herein and therein contain “not purely historical are forward-looking statements” statements within the meaning of Section 27A of the Securities ActAct of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)amended. All statements other than statements of historical facts contained or incorporated herein by reference in this information statement, these including statements reflect regarding our current views with respect to our ongoing and planned clinical trialsfuture operating results, future financial position, business strategy, business planobjectives, financial performance goals, plans, prospects, markets, and other plans and objectives for future eventsoperations, are forward-looking statements. These statements include In some cases, you can identify forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words by terms such as “expectanticipates,” “intendbelieves,” “estimates,” “expects,” “intends,” “targets,” “contemplates,” “projects,” “predicts,” “may,” “might,” “plan,” “believewill,” “projectwould,” “estimateshould,” “could,” “may,” “shouldcan,” “anticipatepotential,” “willcontinue,” and “objective,” or the negative of those terms, or similar statements of a future or forward-looking nature expressions intended to identify forward-looking statements. However, not all forward-looking statements for purposes contain these identifying words. Specific forward-looking statements in this information statement, include statements regarding our expectations regarding the methodology, effects, timing, and tax-free nature of the Separation; our belief that SilverSun will meet the requisite requirements under Delaware law to effect the Separation; our belief that no other material governmental or regulatory filings or approvals will be necessary to consummate the Separation, other than registration under the federal securities laws of our common stock and completion of the applicable trading requirements on the OTCQX for such shares; our expectation that our common stock will be traded on the OTCQX under the ticker symbol “[●]”; our expectation that after the Separation and the Mergers , SilverSun common stock will be traded on Nasdaq under the ticker symbol “RHDMA”; our expectations regarding a “regular-way” market, an “ex-distribution” market, and a “when-issued” market in our shares of common stock between the Record Date and the Distribution Date; our belief that separating SilverSun’s businesses operated through SWK and SCS from SilverSun’s business operated through CCDC and, following the Mergers, Merger Sub II, is in the best interests of SilverSun and its stockholders; our expectations regarding the number of shares of our outstanding common stock, the number of such shares held by our affiliates, and the number of stockholders of record following the Separation; our anticipation regarding the adverse effects of COVID-19 on our business; our belief that maintaining and further enhancing the brand recognition and reputation of our brands is critical to retaining existing customers and attracting new customers and that the importance of our brand recognition and reputation will increase; our plan to continue to expand our brand recognition and product loyalty through social media and our websites with generation of original content; our anticipation that we will enter into new strategic alliances; our expectation that any claims and lawsuits, arising in the ordinary course of business, we are involved in will not have a material adverse effect on our results of operations or otherwisefinancial condition; our intent to pursue acquisitions that financially and strategically complement our business; our belief that we will drive customer satisfaction and loyalty by offering high-quality, innovative products and services on a timely and cost-effective basis; our intent to pursue and challenge infringements of our intellectual property; our expectation to have certain insurance policies in place as of the date of the Separation; our anticipation that any required contract assignments and new agreements will be obtained prior to the Separation; our belief that none of the contracts or other assets requiring consent to transfer or the contracts requiring a new agreement are individually material to our business; our expectation that the expenses to be incurred by SilverSun Holdings for reporting and corporate governance purposes will be commensurate with those being incurred by SilverSun prior to the Mergers; our expected executive officers, directors, and other key employees; our expected corporate governance policies, guidelines, and practices; our anticipated compensation and benefit plans;our belief that several provisions of our Certificate of Incorporation, Bylaws, and Delaware law that may discourage, delay, or prevent a merger or acquisition that stockholders may consider favorable and will protect our stockholders from coercive or otherwise unfair takeover tactics; our expectations of costs and expenses associated with becoming an independent, publicly traded company; our expectation to incur expenditures to establish certain standalone functions, and other one-time costs subsequent to the completion of the Separation; our expectation that nonrecurring amounts, related to the Separation that are incurred prior to the completion of the Separation, will include costs to separate and/or duplicate investment banker fees, third-party legal and accounting fees, and similar costs; our belief we will meet known or reasonably likely future cash requirements through the combination of cash flows from operating activities, available cash balances, and available borrowings through the issuance of third-party debt; and our expectation to utilize our cash flows to continue to invest in our brands, including research and development of new product initiatives, talent and capabilities, and growth strategies, including any potential acquisitions, and to repay any indebtedness we may incur over time. All forward-looking statements involve inherent risks included herein are based on information available to us as of the date hereof and speak only as of such date. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements. The forward-looking statements contained in or incorporated by reference into this information statement reflect our views as of the date of this information statement about future events and are subject to risks, uncertainties, assumptions, and there changes in circumstances that may cause our actual results, performance, or achievements to differ significantly from those expressed or implied in any forward-looking statement. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future events, results, performance, or will be important achievements. A number of factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more Such factors include, among others: the effects of these or other risks or uncertainties materializesthe coronavirus, or if COVID-19, pandemic; lower levels of consumer spending; our underlying assumptions prove ability to be incorrectintroduce new products that are successful in the marketplace; the failure to maintain or strengthen our brand recognition and reputation; the ability to forecast demand for our products or services accurately; our inability to compete in a highly competitive market; our dependence on large customers; pricing pressures by our customers; our ability to collect our accounts receivable the risk of earthquakes, actual results may vary materially from what we anticipate. All subsequent written fire, power outages, power losses, and oral forward-looking statements attributable telecommunication failures; our abilities to us identify acquisition candidates, to complete acquisitions of potential acquisition candidates, our ability to integrate their businesses with our business, and the success of acquired companies; our ability to protect our intellectual property; the risk of complying with any applicable foreign laws or individuals acting regulations and the effect of increased protective tariffs; the performance and security of our information systems; the potential for product recalls, product liability, and other claims against us; our dependable on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stockkey personnel; economic, you should consider carefully all social, political, legislative, and regulatory factors; the state of the U.S. economy; risks associated with our facilities, including the expected benefits; and other factors set forth detailed from time to time in our reports that will be filed with the Securities and Exchange Commission, or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differSEC.
Appears in 1 contract
Samples: Merger Agreement (SilverSun Technologies Holdings, Inc)
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are information incorporated by reference herein in this prospectus supplement and therein accompanying prospectus contain “forward-looking statements” within the meaning of Section 27A of the Securities ActAct of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect which include information relating to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events, future financial performance, strategies, expectations, competitive environment and regulation. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words “expect,” “intend,” “plan,” “believe,” “project,” “estimate,” Words such as “may,” “should,” “anticipatecould,” “willwould,” “predicts,” “potential,” “continue,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, as well as statements of a in future or forward-looking nature tense, identify forward-looking statements for purposes of the federal securities laws or otherwisestatements. All forwardForward-looking statements involve inherent should not be read as a guarantee of future performance or results and will probably not be accurate indications of when such performance or results will be achieved. Forward-looking statements are based on information we have when those statements are made or our management’s good faith belief as of that time with respect to future events, and are subject to risks and uncertainties, and there are or will be important factors uncertainties that could cause actual performance or results to differ materially from those indicated expressed in these or suggested by the forward-looking statements. We believe Important factors that these factors could cause such differences include, but are not limited to: ● our history of recurring losses and negative cash flows from operating activities, those factors set forth under significant future commitments and the caption “Risk Factors” uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; ● our ability to complete clinical trials as anticipated and obtain and maintain regulatory approvals for our products; ● our ability to adequately protect our intellectual property; ● disputes over ownership of intellectual property; ● our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary; ● the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our products are an attractive alternative to other procedures and products; ● intense competition in this prospectus supplement our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; ● entry of new competitors and products and potential technological obsolescence of our products; ● loss of a key customer or supplier; ● adverse economic conditions; ● adverse federal, state and local government regulation, in the accompanying base prospectus United States; ● price increases for supplies and under components; ● inability to carry out research, development and commercialization plans; and ● loss or retirement of key executives and research scientists. Although we believe that the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectuscontained herein are reasonable, we can give no assurance that our expectations will be met. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any All forward-looking statements we may makecontained herein are expressly qualified in their entirety by this cautionary statement and the risk factors beginning on page S-3 of this prospectus supplement. Given these uncertainties, you should You are cautioned not to place undue reliance on these forward- forward-looking statements. You should not assume that the information contained in this prospectus supplement is accurate , which speak only as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as to the extent required by lawapplicable laws and regulations, we assume undertake no obligation to update these forward-looking statements publicly, to reflect events or circumstances after the date of this prospectus or to update reflect the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more occurrence of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differunanticipated events.
Appears in 1 contract
Samples: At Market Issuance Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file have filed with the SEC that are incorporated by reference herein and therein contain “forward-looking statements” within the meaning of Section 27A of the Securities Act, Act and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical facts contained in this prospectus and the documents we have filed with the SEC that are incorporated by reference, these including statements reflect regarding our current views with respect to our ongoing future results of operations and planned clinical trialsconsolidated financial position, business strategy, business planproduct candidates, financial performance planned preclinical studies and other clinical trials, results of clinical trials, research and development costs, manufacturing costs, regulatory approvals, development and advancement of our oral delivery technology, timing and likelihood of success, as well as plans and objectives of management for future eventsoperations, are forward-looking statements. These statements include involve known and unknown risks, uncertainties, and other important factors that are in some cases beyond our control and may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward- looking statements. In some cases, you can identify forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “plantarget,” “project,” “believe,” “project,” “estimate,” “maypredict,” “shouldpotential,” “anticipateseek,” “willaim,” and or “continue” or the negative of these terms or other similar statements of a future or forward-looking nature identify forwardexpressions. Forward-looking statements for purposes of contained in this prospectus and the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there documents we have filed with the SEC that are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors incorporated by reference include, but are not limited to, statements about: • the progress and focus of our current and future clinical trials in the United States and abroad, and the reporting of data from those factors set forth trials; • our ability to advance product candidates into and successfully complete clinical trials; • the beneficial characteristics, safety, efficacy, and therapeutic effects of our product candidates; • our potential and ability to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; • our ability to complete development of the RaniPill HC or any redesign and conduct additional preclinical and clinical studies of the RaniPill HC or any future design of the RaniPill capsule to accommodate target payloads that are larger than the payload capacity of the RaniPill capsule currently used for our product candidates; • our ability to further develop and expand our platform technology; • our ability to utilize our technology platform to generate and advance additional product candidates; • the accuracy of our estimates regarding expenses, future revenue, capital requirements, and needs for additional financing; • our financial performance; • our plans relating to commercializing our product candidates, if approved; • our ability to selectively enter into strategic partnership and the expected potential benefits thereof; • the implementation of our strategic plans for our business and product candidates; • our ability to continue to scale and optimize our manufacturing processes by expanding our use of automation; • our estimates of the number of patients in the United States who suffer from the indications we target and the number of patients that will enroll in our clinical trials; • the size of the market opportunity for our product candidates in each of the indications we target; • our ability to continue to innovate and expand our intellectual property by developing novel formulations and new applications of the RaniPill capsule; • our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available; • the scope of protection we are able to establish and maintain for intellectual property rights, including our technology platform and product candidates; • the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; • our expectations regarding the impact of the COVID-19 pandemic and the conflict between Ukraine and Russia on our business; • developments relating to our competitors and our industry, including competing product candidates and therapies; • our realization of any benefit from our organizational structure, including our obligations under the caption tax receivable agreement, entered into by us and certain members of Rani LLC, and the impact of any payments required to be made thereunder on our liquidity and financial condition; • our use of proceeds from offerings of our securities under this prospectus; and • our expectations regarding the period during which we will qualify as an emerging growth company under the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions described in the section titled “Risk Factors” and elsewhere in this prospectus supplement prospectus. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the accompanying base prospectus and forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, or otherwise. We discuss in greater detail many of these risks under the captions section titled “Risk Factors,” “Business,” contained in the applicable prospectus supplement, in any free writing prospectuses we may authorize for use in connection with a specific offering, and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and in our subsequent most recent Quarterly Reports Report on Form 10-Q/10-Q/A, all of as well as any amendments thereto reflected in subsequent filings with the SEC, which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information are incorporated by reference into this prospectus supplement is accurate in their entirety. Also, these forward-looking statements represent our estimates and assumptions only as of any date other than the date of the document so incorporated by referencecontaining the applicable statement. Except as Unless required by law, we assume undertake no obligation to update these or revise any forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if reflect new information becomes available or future events or developments. You should read this prospectus, any applicable prospectus supplement, together with the documents we have filed with the SEC that are incorporated by reference and any free writing prospectus that we may authorize for use in connection with a specific offering completely and with the future. Thus, you should not assume understanding that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual future results may vary be materially different from what we anticipateexpect. All subsequent written and oral We qualify all of the forward-looking statements attributable in the foregoing documents by these cautionary statements. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all as of the factors set forth date of this prospectus, and while we believe such information forms a reasonable basis for such statements, such information may be limited or referred incomplete, and our statements should not be read to in this prospectus supplement indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and in the accompanying base prospectus that could cause actual results you are cautioned not to differunduly rely upon these statements.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are incorporated by reference herein and therein Certain statements contained in this Memorandum discuss future expectations, contain projections of results of operations or financial condition, or state other “forward-looking statementslooking” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the information. The words “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words believe,” “expect,” “intendanticipate,” “plan,” “believe,” “projectintend,” “estimate,” “may,” “should,” “anticipatecould,” “will,” “plan,” “future,” “continue,” and similar statements other expressions that are predictions of a or indicate future or forward-looking nature events and trends and that do not relate to historical matters identify forward-looking statements for purposes of the federal securities laws or otherwisestatements. All These forward-looking statements involve inherent are based largely on the expectations or forecasts of future events, can be affected by inaccurate assumptions, and are subject to various business risks and known and unknown uncertainties, and there a number of which are or will be important beyond the control of management. Therefore, the actual results could differ materially from the forward-looking statements contained in this Memorandum. Important factors that could may cause the actual results to differ materially from those indicated in these the forward-looking statements. We believe that these factors , projections or other expectations include, but are not limited to, those factors set forth under the caption “Risk Factors” following: · our ability to raise sufficient capital to implement our business plan; · risks generally associated with the exploration and development of oil and gas reserves; · whether we will be able to develop or acquire additional oil and gas leasehold interests; · competition from larger, more established companies with far greater economic and human resources than us; · our ability to attract and retain customers and quality employees and consultants; · the effect of changing economic conditions; · changes in this prospectus supplement government regulations, tax rates and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis similar matters; · lack of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, operating history; · risks that are not generally recoverable from third parties or insurance; · risks relating to contracting substantially all of which you should review carefullythe operations and revenue generating activities to a third party; and · availability and cost of credit. Please consider our We do not promise to update forward-looking information to reflect actual results or changes in assumptions or other factors that could affect statements made in light of those risks as you read this prospectus supplement and Memorandum. THE CLOSING OF THIS OFFERING AND THE RELEASE OF THE MINIMUM OFFERING PROCEEDS IS SUBJECT TO THE CLOSING AND EFFECTIVE DATE OF THE MERGER. SEE THE DESCRIPTION OF THE MERGER IN THE “COMPANY” SECTION BEGINNING ON PAGE 21 HEREIN. No person has been authorized to give any information or to make any representations in connection with the accompanying base prospectus. It is not possible for our management to predict all risksoffer made by this Memorandum, nor can we assess the impact of all factors on our business has any person been authorized to give any information or the extent to which make any factor, or combination of factors, may cause actual results to differ materially from representations other than those contained in this Memorandum, and if given or made, such information or representations must not be relied upon. This Memorandum does not constitute an offer to sell or solicitation of an offer to buy in any forward-looking statements we may makejurisdiction in which such offer or solicitation would be unlawful, or to any person to whom it is unlawful to make such offer or solicitation. Given these uncertaintiesNeither the delivery of this Memorandum nor any sale made hereunder shall, you should not place undue reliance under any circumstances, creates an implication that there has been no change in the affairs of the Company since the date hereof. This Memorandum is submitted on these forward- looking statementsa confidential basis for use by a limited number of prospective investors solely in consideration of the purchase of the Units described herein in a private placement. You should not assume that The acceptance of this Memorandum constitutes an agreement on the part of the recipient hereof and the recipient’s representatives to maintain the confidentiality of the information contained herein. This Memorandum may not be reproduced in whole or in part. The use of this prospectus supplement is accurate as of Memorandum for any date purpose other than the date on evaluation of the front investment in the Units described herein is not authorized and is prohibited. This Memorandum and all other material delivered to prospective investors shall be returned to the Company if: (a) you do not subscribe to purchase any Units; (b) your subscription is not accepted; (c) this Offering is terminated or withdrawn; or (d) upon request of Wxxxxxxx Products Corp. This Memorandum does not purport to be all-inclusive or to contain all the information that a prospective investor may desire in determining whether to subscribe to purchase any Units. Prospective investors should not construe the contents of this prospectus supplementMemorandum or any other communications from Wxxxxxxx Products Corp. or any of its affiliates, officers, employees, or that any information incorporated by reference into this prospectus supplement is accurate professional representatives as of any date other than being legal, tax or financial advice. Each prospective investor should consult his or her own counsel, accountant or business advisors concerning an investment in the date Units offered hereby. Prior to the closing of the document so incorporated by reference. Except as required by lawOffering, we assume no obligation Wxxxxxxx Products Corp. will afford prospective investors or their representatives and advisors the opportunity to update these forward-looking statements publiclyask questions of, and receive answers from, Wxxxxxxx Products Corp. or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals persons acting on our its behalf are expressly qualified in their entirety by concerning the terms and conditions of this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred Offering and to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differ.obtain additional information about Wxxxxxxx Products Corp.
Appears in 1 contract
Samples: Private Placement Memorandum (Westcott Products Corp)
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and supplement, the accompanying base prospectus and the documents we file with the SEC that are incorporated by reference herein and therein contain “forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this prospectus supplement, the accompanying prospectus or the documents incorporated herein or therein by reference regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The words “anticipate,” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “believepredict,” “project,” “estimatewill,” “maywould,” “could,” “should,” “anticipatepotential,” “willseek,” “evaluate,” “pursue,” “continue,” “design,” “impact,” “affect,” “forecast,” “target,” “outlook,” “initiative,” “objective,” “designed,” “priorities,” “goal,” or the negative of such terms and similar statements of a future or forward-looking nature expressions are intended to identify forward-looking statements for purposes of the federal securities laws or otherwise. All statements, although not all forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in contain these statementsidentifying words. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our The forward-looking statements in light of those risks as you read this prospectus supplement supplement, the accompanying prospectus and the accompanying base prospectus. It is not possible for documents incorporated herein by reference include, among other things, statements about: • our management to predict all riskspost-separation relationships with Recro, nor can we assess the impact of all factors on third parties, licensors, collaborators and our employees; • our business and operations following the separation with Recro, and any benefits or costs of the extent separation with Recro; • our ability to which any factoroperate as a standalone company and execute our strategic priorities; • our estimates regarding expenses, future revenue, capital requirements and timing and availability of and the need for additional financing; • whether the FDA will approve our amended New Drug Application, or combination NDA for IV meloxicam and, if approved, the timing of factorsand the labeling under any such approval that we may obtain; • if the FDA does not approve our amended NDA, the time frame otherwise associated with resolving the deficiencies identified by the FDA in the CRL and whether the FDA will require additional clinical studies to support the approval of IV meloxicam and the time and cost of such studies; • our ability to successfully commercialize IV meloxicam or our other product candidates, upon regulatory approval; • our ability to generate sales and other revenues from IV meloxicam or any of our other product candidates, once approved, including, addressing any FDA action related to the meloxicam NDA, setting an acceptable price for and obtaining adequate coverage and reimbursement of such products; • the results, timing and outcome of our clinical trials of IV meloxicam or our other product candidates, and any future clinical and preclinical studies; • our ability to raise future financing and attain profitability for continued development of our business and our product candidates and to meet required debt payments, and any milestone payments owing to Alkermes plc, or our other licensing and collaboration partners; • our ability to comply with the regulatory schemes applicable to our business and other regulatory developments in the United States and foreign countries; • the performance of third-parties upon which we depend, including third-party contract research organizations, or CRO’s, and third-party suppliers, manufacturers, group purchasing organizations, distributors and logistics providers; • our ability to obtain and maintain patent protection and defend our intellectual property rights against third parties; • our ability to maintain our relationships, profitability and contracts with our key commercial partners; • our ability to defend any material litigation filed against us, including the ongoing securities class action filed against Recro that we have agreed to indemnify Recro; • our ability to recruit or retain key scientific, technical, commercial, and management personnel or to retain our executive officers; • our ability to comply with stringent U.S. and foreign government regulation in the manufacture of pharmaceutical products, including Good Manufacturing Practice, or cGMP, compliance and U.S. Drug Enforcement Agency, or DEA, compliance and other relevant regulatory authorities; and • the effects of changes in our effective tax rate due to changes in the mix of earnings in countries with differing statutory tax rates, changes in the valuation of deferred tax assets and liabilities, tax impacts and net operating loss utilization related to the separation from Recro and changes in the tax laws. We may cause actual results to differ materially from those contained not actually achieve the plans, intentions or expectations disclosed in any our forward-looking statements we may make. Given these uncertaintiesstatements, and you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one Actual results or more of these or other risks or uncertainties materializesevents could differ materially from the plans, or if our underlying assumptions prove to be incorrectintentions and expectations disclosed in the forward- looking statements we make. We have included important factors in the cautionary statements included in this prospectus, particularly under “Risk Factors,” that we believe could cause actual results may vary or events to differ materially from what we anticipate. All subsequent written and oral the forward-looking statements attributable that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, collaborations or investments we may make. You should read this prospectus supplement, the accompanying prospectus and the documents that we incorporate by reference herein and therein completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to us update any forward-looking statements. We may issue and sell shares of our common stock having aggregate sale proceeds of up to $25,000,000 from time to time. Because there is no minimum offering amount required to be sold in connection with this offering, the actual total public offering amount, commissions and proceeds to us, if any, are not determinable at this time. We intend to use the net proceeds of the proposed offering for preparatory commercial activities for the potential commercial launch of IV meloxicam, pipeline development activities, and general corporate purposes. These expected uses represent our intentions based upon our current plans and business conditions, which could change in the future as our plans and business conditions evolve. The amounts and timing of our actual expenditures may vary significantly depending on numerous factors, including the progress of our development, the status of and results from clinical trials, as well as any new collaborations that we may enter into with third parties for our product candidates, the commercialization of our product candidates, if approved, and any unforeseen cash needs. As a result, our management will have broad discretion in the application of the net proceeds from this offering, and investors will be relying on the judgment of our management regarding the application of the net proceeds from this offering. Pending application of the net proceeds as described above, we intend to invest the net proceeds of this offering in short-term, investment-grade, interest-bearing securities. We have never declared or individuals acting paid any cash dividends on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock. We currently intend to retain all available funds and any future earnings, you should consider carefully all if any, to fund the development and expansion of the factors set forth or referred to in this prospectus supplement our business and we do not anticipate paying any cash dividends in the accompanying base prospectus that could cause actual foreseeable future. Any future determination to pay dividends on our common stock will be made at the discretion of our board of directors and will depend on various factors, including applicable laws, our results to differof operations, financial condition, future prospects, anticipated cash needs, plans for expansion and any other factors deemed relevant by our board of directors.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are incorporated by reference herein and therein contain “forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include report contains forward-looking statements both with respect to us, specifically, that involve substantial risks and the biotechnology sector, in generaluncertainties. We make In some cases you can identify these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words “expect,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or by forward-looking nature identify words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "should," "will," and "would" or similar words. You should read statements that contain these words carefully because they discuss future expectations, contain projections of future results of operations or of financial position or state other "forward-looking statements for purposes of the federal securities laws or otherwiselooking" information. All forward-looking statements involve inherent risks and uncertainties, and there are or will be The important factors listed above in the section captioned "Risk Factors," as well as any cautionary language in this report, provide examples of risks, uncertainties and events that could may cause the actual results of either company to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated expectations described in these forward-looking statements. You should be aware that the occurrence of the events described in these risk factors and elsewhere in this report could have a material adverse effect on the business, even if new information becomes available results of operations and financial position of Sonus. Any forward-looking statements in the futurethis report are not guarantees of future performances, and actual results, developments and business decisions may differ from those envisaged by such forward- looking statements, possibly materially. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such Sonus disclaims any duty to update any forward-looking statements. If one or more , all of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf which are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to statements in this prospectus supplement section. ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK. We do not currently use derivative financial instruments. We generally place our marketable security investments in high-quality credit instruments, primarily U.S. Government obligations and corporate obligations with contractual maturities of less than one year. We do not expect any material loss from our marketable security investments and therefore believe that our potential interest rate exposure is not material. To date, sales from our international operations have been made in United States dollars. Accordingly, we have no material exposure to foreign currency rate fluctuations, though we will continue to evaluate the accompanying base prospectus that could cause actual impact of foreign currency exchange risk on our results to differof operations as we expand internationally.
Appears in 1 contract
Samples: Annual Report
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This Various statements in this prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are incorporated by reference herein and therein contain “forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 19951995 and other U.S. Federal securities laws. Statements In addition, historic results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials would not be different, and historic results referred to in this prospectus may be interpreted differently in light of additional research and clinical and preclinical trials results. Forward-looking statements include the words all statements that are not historical facts. We have based these forward-looking statements largely on our management’s current expectations and future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Forward-looking statements involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this prospectus and any documents incorporated by reference herein regarding our strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management are forward-looking statements. These statements are subject to risks and uncertainties and are based on information currently available to our management. Words such as, but not limited to, “anticipate,” “believe,” “contemplates,” “continue,” “could,” “design,” “estimate,” “expect,” “intend,” “likely,” “may,” “ongoing,” “plan,” “believepotential,” “predict,” “project,” “estimatewill,” “maywould,” “seek,” “should,” “anticipatetarget,” “will” or the negative of these terms and similar statements of a future expressions or forward-looking nature words, identify forward-looking statements for purposes of the federal securities laws or otherwisestatements. All The events and circumstances reflected in our forward-looking statements involve inherent risks may not occur and uncertainties, and there are or will be important actual results could differ materially from those projected in our forward-looking statements. Meaningful factors that which could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to: • the scope, those factors set forth under progress and costs of developing our product candidates such as EB613 for Osteoporosis and EB 612 for Hypoparathyroidism; • the caption “Risk Factors” in this prospectus supplement and in accuracy of our estimates regarding expenses, capital requirements, the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis sufficiency of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement cash resources and the accompanying base prospectus. It is not possible need for additional financing; • our management ability to predict all risksraise additional funds on commercially reasonable terms; • our ability to develop, nor can advance product candidates into, and successfully complete, clinical studies such as our ongoing Phase 2 clinical trial of EB613 in osteoporosis; • our reliance on third parties to conduct our clinical trials and on third-party suppliers to supply or produce our product candidates; • our expectations regarding licensing, business transactions and strategic collaborations; • our operation as a development stage company with limited operating history and a prior record of operating losses as well as our ability to fund our operations going forward; • our ability to continue as a going concern absent access to sources of liquidity; • our interpretation of FDA feedback and guidance and how such guidance may impact our clinical development plans, specifically our ability to utilize the 505(b)(2) pathway for the development and potential approval of EB613 and any other product candidates we assess may develop; • our ability to obtain and maintain regulatory approval for any of our product candidates; • our competitive position, especially with respect to Forteo® and other products on the impact market or in development for the treatment of all factors osteoporosis; • our ability to establish and maintain development and commercialization collaborations; • any potential commercial launch of current or future product candidates, and the timing, cost or other aspects of such commercialization; • our ability to manufacture and supply sufficient amounts of material to support our clinical trials and any potential future commercial requirements; • our ability to use and expand our drug delivery technology to additional product candidates; • the safety and efficacy of therapeutics marketed by competitors that are targeted toward indications for which we are developing product candidates; • the size of any market we may target and the adoption of our product candidates, if approved, by physicians and patients; • our ability to obtain, maintain and protect our intellectual property and operate our business without infringing misappropriating or otherwise violating any intellectual property rights of others; • our ability to retain key personnel and recruit additional qualified personnel; • the possibility that competing products or technologies may make any product candidates we may develop and commercialize or our oral delivery technology obsolete; • the pricing and reimbursement of our product candidates, if approved; • our ability to develop a sales, marketing and distribution infrastructure, if any; • our ability to manage growth; and • the duration and severity of the recent coronavirus (COVID-19) outbreak, the actions that may be required to contain COVID-19 or treat its impact, and its effect on our business or the extent to which any factoroperations and workforce, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that including our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipateresearch and development and clinical trials. All subsequent written and oral verbal forward-looking statements attributable to us or individuals any person acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth cautionary statements contained or referred to in this prospectus supplement section. We caution investors not to rely too heavily on the forward-looking statements we make or that are made on our behalf. Except as required by law, we are under no duty, and expressly disclaim any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. You are advised, however, to consult any further disclosures we make on related subjects in any annual, quarterly or current reports that we may file with the accompanying base prospectus that could cause actual results to differSecurities and Exchange Commission.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are incorporated by reference herein and therein contain “contains forward-looking statements” statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (amended, or the “Exchange Act”). All statements, these other than statements reflect of historical fact, included or incorporated by reference in this prospectus supplement regarding our current views with respect to our ongoing and planned clinical trials, business strategy, business planfuture operations, collaborations, intellectual property, cash resources, financial performance position, future revenues, projected costs, prospects, plans and other future events. These statements include objectives are forward-looking statements both with respect to us, specifically, and the biotechnology sector, in generalstatements. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the The words “expectbelieves,” “intendanticipates,” “planestimates,” “believeplans,” “projectexpects,” “estimateintends,” “may,” “could,” “should,” “anticipatepotential,” “likely,” “projects,” “continue,” “will,” and “would” and similar statements of a future or forward-looking nature expressions are intended to identify forward-looking statements for purposes of the federal securities laws or otherwise. All statements, although not all forward-looking statements involve inherent risks contain these identifying words. We cannot guarantee that we actually will achieve the plans, intentions or expectations disclosed in our forward-looking statements and uncertainties, and there you should not place undue reliance on our forward-looking statements. There are or will be a number of important factors that could cause our actual results to differ materially from those indicated in these or implied by forward-looking statements. We believe that these These important factors include, but are not limited to, include those factors set forth above under the caption heading “Risk Factors” in this prospectus supplement supplement, the accompanying prospectus and in the accompanying base reports incorporated by reference herein and therein. These factors and the other cautionary statements made in this prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, supplement or incorporated by reference herein should be read as being applicable to all of which you should review carefully. Please consider our related forward-looking statements whenever they appear in light of those risks as you read this prospectus supplement and or in the accompanying base prospectusreports incorporated by reference herein. It is not possible for our management to predict all risksIn addition, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume represent our estimates only as of the date that the information contained in this prospectus supplement is accurate filed with the SEC, and should not be relied upon as representing our estimates as of any date other than the date on the front of this prospectus supplement, or that subsequent date. We do not assume any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such any forward-looking statements. If one We disclaim any intention or more of these obligation to update or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral revise any forward-looking statements attributable to us statement, whether as a result of new information, future events or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differotherwise.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus prospectus, and the documents we file with the SEC that are incorporated in this prospectus by reference herein and therein reference, contain “forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include are based on our management’s current beliefs, expectations and assumptions about future events, conditions and results and on information currently available to us. Discussions containing these forward-looking statements both with respect to usmay be found, specifically, and the biotechnology sectoramong other places, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words sections titled “expectBusiness,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or forward-looking nature identify forward-looking statements for purposes of the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in incorporated by reference from our most recent Annual Report on Form 10-K and our subsequent most recent Quarterly Reports Report on Form 10-Q/10-Q/A, all of which as well as any amendments thereto, filed with the SEC. In some cases, you should review carefully. Please consider our can identify forward-looking statements in light by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “positioned,” “potential,” “seek,” “should,” “target,” “will,” “would” or the negative or plural of those risks as you read terms, and similar expressions intended to identify statements about the future, although not all forward-looking statements contain these words. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these statements. Any statements in this prospectus, or incorporated herein by reference, about our expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are forward-looking statements. Within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act these forward-looking statements include statements regarding: • statements regarding the impact of the ongoing COVID-19 pandemic and its effects on our operations, research and development, clinical trials and financial position, and its potential effects on the operations of third-party manufacturers, contract research organizations, other service providers, and collaborators with whom we conduct business; • our plans to develop and commercialize our product candidates; • the initiation, timing, progress and expected results of our current and future clinical trials and our research and development programs; • our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; • our ability to successfully acquire xxxx-license additional product candidates or other technology on reasonable terms; • our ability to maintain and establish collaborations or strategic relationships or obtain additional funding; • the timing and likelihood of obtaining regulatory approval of our current and future product candidates; • our expectations regarding the potential market size and the rate and degree of market acceptance of such product candidates; • our ability to fund our working capital requirements and expectations regarding the sufficiency of our capital resources; • the implementation of our business model and strategic plans for our business and product candidates; • the scope of protection we are able to establish and maintain for intellectual property rights and the duration of our patent rights covering our product candidates; • developments or disputes concerning our intellectual property or other proprietary rights; • the scalability and commercial viability of our manufacturing methods and processes; • our expectations regarding government and third-party payor coverage and reimbursement; • our ability to compete in the markets for our product candidates; • the impact of government laws and regulations; • developments relating to our competitors and our industry; • the factors that may impact our financial results; and • our expected use of proceeds from any offering under this prospectus supplement. You should refer to the “Risk Factors” section contained in this prospectus supplement, the accompanying prospectus and any related free writing prospectus, and under similar headings in the other documents that are incorporated by reference into this prospectus supplement and the accompanying base prospectus. It is not possible , for our management to predict all risks, nor can we assess the impact a discussion of all important factors on our business or the extent to which any factor, or combination of factors, that may cause our actual results to differ materially from those contained in any forward-expressed or implied by our forward- looking statements we may makestatements. Given these uncertaintiesrisks, uncertainties and other factors, many of which are beyond our control, we cannot assure you that the forward- looking statements in this prospectus supplement and the accompanying prospectus will prove to be accurate, and you should not place undue reliance on these forward- forward-looking statements. You Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not assume regard these statements as a representation or warranty by us or any other person that the information contained we will achieve our objectives and plans in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplementspecified time frame, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by referenceat all. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these revise any forward-looking statementsstatements to reflect events or developments occurring after the date of this prospectus supplement, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differ.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and Memorandum, including the accompanying base prospectus and White Paper, contains forward-looking statements. Except for the documents we file with statements of historical fact contained herein, the SEC that are incorporated by reference herein and therein contain information presented constitutes “forward-looking statements.” within the meaning of Section 27A of the Securities ActOften, and Section 21E of the Securities Exchange Act of 1934but not always, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, and can be identified by the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions use of the Private Securities Litigation Reform Act of 1995. Statements that include the words such as “expectplans,” “intendexpects,” “planbudget,” “believescheduled,” “projectestimates,” “estimateforecasts,” “mayintends,” “shouldanticipates,” “anticipatebelieves,” “will” or variation of such words and similar statements of a future phrases that refer to certain actions, events or forward-looking nature identify results to be taken, occur or achieved. The forward-looking statements for purposes of are contained principally in the federal securities laws or otherwiseWhite Paper. All forwardForward-looking statements involve inherent risks known and uncertaintiesunknown risks, uncertainties and there are other factors which may cause the actual results, performance or will achievements of Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include those factors discussed in the section of this Memorandum entitled “Risk Factors.” Although Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those indicated described in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended. There can be no assurance that such statements in light of those risks will prove to be accurate as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to and future events could differ materially from those contained anticipated in any forward-looking statements we may makesuch statements. Given these uncertaintiesAccordingly, you readers should not place undue reliance on these forward- forward-looking statements. You should not assume that the information contained in this prospectus supplement is accurate Also, forward-looking statements represent Company’s estimates and assumptions only as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of this Memorandum. You should read this Memorandum completely and with the document so incorporated by referenceunderstanding that Company’s actual future results may be materially different from what it expects. Except as required by law, we assume Company assumes no obligation to update these any forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these any forward-looking statements, even if new information becomes available in the future. ThusSALE OF THE TOKENS The Tokens will be sold by the company directly. However from time to time the company may engage with private parties that meet the necessary exemptions under the Securities Act and those rules as laid out by FINRA and the SEC. This includes paying NO commission or any ‘finders fee’ but may include a monthly ‘service fee’ as permitted by FINAR rules. The company will only be selling to Accredited Investors who will be required to produce evidence of their Qualified Investor Status. YOU WILL BE ASKED TO PROVIDE EVIDENCE OF YOUR ACCREDITED STATUS. Company Overview (PLEASE FILL THIS IN) - Include patents The company will be using professional advisors from the Financial, you should not assume that our silence over time means that actual events are bearing Crypto, Blockchain, Software, Digital, Technological, and other industries. You can find out as expressed or implied in such forward-looking statements. If one or more of information about these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting advisors on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement company website and in the accompanying base prospectus WhitePaper as produced by the company and amend from time to time. The Company will be working in ‘partnership’ with several other companies. Although the term ‘partnership’ is used, this is in no way to be designed to construe or imply a ‘legal’ partnership between the companies. The term is loosely fitting as to the close working relationship between two independent companies seeking mutual gain under the relevant contracts. The Company is working carefully with Xxxxxxx International. An international legal and compliance firm with offices in the UK, US, and Asia. From time to time they may contact individuals who are looking to participate if they need to verify identification or confirm some other information. Sometimes, legal proceedings occur for any of number of reasons. In the event of Major legal proceedings it maybe necessary for the company to divert resources and including financial reserves to defend or bring such legal actions as necessary to protect the company and its interests. Such actions could have a negative impact on the company and its operations. Any investor should be aware of this. However, at this time the company has no current or anticipated legal proceedings. Company hereby offers (the “Offering”) certain securities, which are tied to electronic digital cryptographic tokens sometimes known as Cryptocurrencies. Such warrants (the “Warrants”) and the securities, including certain rights (the “Rights”) to participate in the ownership of cryptographic security tokens (the “Security Tokens”) with the terms as laid out in this document and as amended from time to time on the company website under this Purchase & Subscription Agreement (“Purchase Agreement”). The Token Sale is described in the White Paper is incorporated by reference into this document the information contained in the White Paper (such documents, together, this “Memorandum”). Capitalized terms that could cause actual results are not otherwise defined have the meanings set forth in the White Paper or the Purchase Agreement, as applicable. This Memorandum has been prepared by Company for delivery to differpotential Purchasers in the Offering. No assurance can be given that all or any portion of the Securities offered hereby will be sold or that the Token Sale will take place or close. The Securities have not been registered in any jurisdiction; no market exists for the Securities; and the Securities are restricted from transfer. An investment in the Securities is speculative and involves a substantial degree of risk. Purchasers should be aware that they will be required to bear the financial risks of this investment for an indefinite period of time. The Securities are cryptographic tokens which represent shares within the company. Each Cryptographic token represents 1 share. In a modern age, this is effectively the digitization of the shares of a company. The shares in this case are as defined below. The Issuer ESG Digital, LLC. A company formed under the laws of the State of Wyoming USA. Financing Amount The company is looking to obtain 50,000,000 FIFTY MILLION DOLLARS. Investor Any individual who purchases Tokens under this Agreement. Cryptographic Tokens Representative of Shares of the company. Classed as Digital Shares. Shares Class B (Ordinary) - No voting rights, Dividend Rights, or other rights associated with control of the company. PPM Private Placement Memorandum (Forming Part of this Document). Subscription and Purchase Agreement This Document Lockin Period A period of 12 months as prescribed by the Securities Act (as Amended). Not a Security In relevant jurisdictions the issuing of these Cryptographic tokens shall not be classed as a security. Governing Law State of Wyoming with jurisdiction given at a federal level to the SEC. STO Security Token Off ering. The period of which these tokens will be sold. As the company is offering tokens representing Shares in the company, purchaser hereby recognizes that the class of share carries with it either full or zero voting rights and is representative of its respective class. All Class of shares, are deemed to have waived and exempted from all associated rights, warranties, dividends, or promises that come with such shares except for expressly given under this agreement and in accordance with the Articles of Incorporation. Any and all rights can be changed, paused, or removed by a vote of the shareholders providing that a quorum is met and the board fully approves such a resolution. ANY AND ALL DIVIDEND UNDER ANY CLASS OF SHARE IS NOT MANDATORY OR AUTOMATIC. ANY SUCH MEASURE SHALL BE VOTED ON BY THE SHAREHOLDERS UNDER THEIR RESPECTIVE CLASS CARRYING SUCH RIGHTS TO VOTE. ALL SHAREHOLDERS ARE DEEMED TO HAVE WAIVED THEIR STATUTORY SHAREHOLDER RIGHTS.
Appears in 1 contract
Samples: Subscription & Purchase Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are incorporated by reference herein and therein contain “contains forward-looking statements” statements within the meaning of Section 27A of the Securities ActAct of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)amended, these which statements reflect involve substantial risks and uncertainties. Forward-looking statements generally relate to future events or our current views with respect to our ongoing and planned clinical trialsfuture financial or operating performance. In some cases, business strategy, business plan, financial performance and other future events. These statements include you can identify forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the because they contain words such as “expectmay,” “intend,” “plan,” “believe,” “project,” “estimate,” “maywill,” “should,” “anticipateexpects,” “willplans,” and “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these words or other similar statements of a future terms or forward-looking nature identify forwardexpressions that concern our expectations, strategy, plans or intentions. Forward-looking statements for purposes of contained in this prospectus supplement, the federal securities laws or otherwise. All forward-looking statements involve inherent risks accompanying prospectus and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated the documents incorporated by reference in these statements. We believe that these factors this prospectus supplement include, but are not limited to, those factors set forth under statements about: · the caption “Risk Factors” development of our drug candidates, including when we expect to undertake, initiate and complete clinical trials of our product candidates; · expectation of or dates for commencement of clinical trials, investigational new drug filings and similar plans or projections; · the regulatory approval of our drug candidates; · our use of clinical research centers, third party manufacturers and other contractors; · our ability to find collaborative partners for research, development and commercialization of potential products; · our ability to manufacture products for clinical and commercial use; · our ability to protect our patents and other intellectual property; · our ability to market any of our products; · our ability to compete against other companies and research institutions; · our ability to expand our operations internationally; · the effect of potential strategic transactions on our business; · acceptance of our products by doctors, patients or payors and the availability of reimbursement for our product candidates; · our ability to attract and retain key personnel; and · the volatility of our stock price. We caution you that the forward-looking statements highlighted above do not encompass all of the forward-looking statements made in this prospectus supplement. You should not rely upon forward-looking statements as predictions of future events. We have based the forward-looking statements contained in this prospectus supplement primarily on our current expectations and projections about future events and trends that we believe may affect our business, financial condition, results of operations and prospects. The outcome of the events described in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our these forward-looking statements is subject to risks, uncertainties and other factors. Moreover, we operate in light of those a very competitive and challenging environment. New risks as you read this prospectus supplement and the accompanying base prospectus. It uncertainties emerge from time to time, and it is not possible for our management us to predict all risksrisks and uncertainties that could have an impact on the forward-looking statements contained in this prospectus supplement. We cannot assure you that the results, nor can we assess events and circumstances reflected in the impact of all factors on our business forward-looking statements will be achieved or the extent to which any factoroccur, and actual results, events or combination of factors, may cause actual results to circumstances could differ materially from those contained described in the forward-looking statements. Additionally, final data may differ significantly from preliminary data reported in this prospectus supplement. The forward-looking statements made in this prospectus supplement relate only to events as of the date on which the statements are made. We undertake no obligation to update any forward-looking statements we made in this prospectus supplement to reflect events or circumstances after the date of this prospectus supplement or to reflect new information or the occurrence of unanticipated events, except as required by law. We may make. Given these uncertaintiesnot actually achieve the plans, intentions or expectations disclosed in our forward- looking statements and you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral Our forward-looking statements attributable to us do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or individuals acting investments we may make, if any. This prospectus supplement also contains statistical data, estimates and forecasts that are based on independent industry publications or other publicly available information, as well as other information based on our behalf are expressly qualified in their entirety by this Noteinternal sources. Before purchasing any shares of common stock, you should consider carefully all of Although we believe that the factors set forth or third-party sources referred to in this prospectus supplement are reliable, we have not independently verified the information provided by these third parties. While we are not aware of any misstatements regarding any third-party information presented in this prospectus supplement, their estimates, in particular, as they relate to projections, involve numerous assumptions, are subject to risks and in the accompanying base prospectus that could cause actual results uncertainties, and are subject to differchange based on various factors.
Appears in 1 contract
Samples: Common Stock Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement Some of the statements contained in this Memorandum, including statements contained in the sections captioned "EXECUTIVE SUMMARY," "CARTIS ORGANIZATION STRUCTURE, MANAGEMENT, PRODUCTION, SALES & MARKETING", "COMPETITION" and "FINANCIAL PROJECTIONS" discuss future expectations and intentions, contain projections of results of operations or financial condition or state other "forward-looking" information. Such statements can be identified by the accompanying base prospectus and the documents we file with the SEC that are incorporated by reference herein and therein contain “use of forward-looking statements” within the meaning of Section 27A of the Securities Actterminology such as "plan," "intend," "hope," "may," "will," "expect," "anticipate," "estimate," "continue" or other similar words. Statements are subject to known and unknown risks, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance uncertainties and other future events. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words “expect,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or forward-looking nature identify forward-looking statements for purposes of the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause the actual results to differ materially from those indicated in these contemplated by the statements. We believe that these factors include, but are not limited to, those factors set forth under Investors should consult the caption “"Risk Factors” " contained herein in this prospectus supplement and in order to assess the accompanying base prospectus and under risks involved with the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefullyinvestment. Please consider our The forward-looking information is based on various factors and was derived using numerous assumptions. When considering such forward-looking statements, you should keep in mind the risk factors referenced above and other cautionary statements in light of those risks as you read this prospectus supplement and the accompanying base prospectusMemorandum. It is not possible for our management to predict all risks, nor can we assess the impact of all Important factors on our business or the extent to which any factor, or combination of factors, that may cause actual results to differ materially from those contained the Company's projections include, for example: the success or failure of the Company's test trials on new products; the Company's ability to enter into joint venture, co-marketing or other strategic partnering relationships with established companies; marketplace acceptance of the Company's water purification products; whether other companies develop products which are competitive with the Company's; The Company's ability to obtain future financing to fund Company growth and the Company's continued transition to commercial operations; the Company's ability to negotiate and maintain favorable distribution arrangements for the Company's products; changes in any government regulations; and the Company's ability to attract and retain qualified employees. The Company does not undertake to update forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking information to reflect actual results or changes in assumptions or other factors that could affect those statements. You should not assume Private and Confidential Cartis Incorporated EXECUTIVE SUMMARY Cartis has discovered, developed, commercialized and patented a new state-of-the-art process to purify water at low cost, and in quantities that are adequate to supply the potable water requirements of human consumption, including drinking, cooking and other domestic needs. The CARTIS process can also greatly improve vegetable growing in greenhouses. Management believes that the information contained water quality after CARTIS treatment often surpasses other commonly available methods and sources of potable water, including bottled water. *** The huge potable water markets around the world rely on a variety of well-known and documented treatment and filtration methods. Most often, these methods only bring partial solutions to water pollution problems. The main methods and processes most commonly in this prospectus supplement use around the world utilize: * UV lamps, which almost totally destroy bacteria in clear water, are limited to bacteria elimination only, * Active Carbon ("AC") is accurate as renowned for the elimination of any date other than odors, chlorine, heavy metals and pesticides. Since AC does not destroy bacteria, its usage is severely limited by rapid bacterial saturation, which forces frequent filter replacements. Also, water treated with AC is void of bactericidal properties, * Active Carbon with Silver Coating solves the date issue of internal bacteria contamination, but its process is severely limited by the risk of silver nitrate pollution, a heavy metal, and a short useful life. In order to prevent silver nitrate pollution, forbidden in most developed countries, the quantity of nitrate coating is kept to a minimum, thereby greatly diminishing its usefulness. * Water Softeners suppress calcium, which is responsible for water hardness and limestone deposits. However these softeners diminish the cleaning properties of water and give it an unpleasant taste. Moreover, softeners facilitate bacteria proliferation. CARTIS incorporates several existing proven methods of water filtration and treatment, while significantly improving on them. CARTIS breakthrough technology creates a permanent bond between pure silver and active carbon, thereby joining one of the best bactericidal agent with a time tested pollution screener. This technology delivers potable water without harming the delicate balance of minerals naturally present in water. The CARTIS showcase product currently on the front market is the Potable Water System PWS 300. The PWS 300 provides potable water void of this prospectus supplementlimestone to households, or that any information incorporated hospitals, schools, hotels, without the use of chlorine. Water treated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statementsCARTIS keeps destroying bacteria, even if new information becomes available after treatment. The PWS 300 incorporates the following elements: * One coarse filter for large impurities, then downstream, * One Xxxxxxxx UV lamp with an output of 25,000 millijoules that corresponds to European standards and surpasses US standards for potable water. The lamp's output is sufficient to eliminate bacteria up to 99% in clear water, then downstream, * One CARTIS cartridge. The cartridge contains a powder composed of pure silver 99.9999 (6N) bonded by intermolecular links to active carbon. The bond is performed in radio frequency, low-pressure cold plasma reactors. The CARTIS process is patented worldwide. The bonding of silver and active carbon ensures bacteria destruction during and after treatment, while eliminating the futureproblem of silver nitrates pollution. ThusChlorine, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statementsa harmful chemical, is the only competing product to CARTIS with similar conservation properties of bacteria destruction after treatment. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written Private and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differ.Confidential
Appears in 1 contract
Samples: Confidential Private Placement Memorandum (Cartis Inc)
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are incorporated by reference herein and therein into this prospectus contain “forward-looking statements” statements within the meaning of Section 27A of the Securities Act, Act and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing that involve substantial risks and planned clinical trialsuncertainties. In some cases, business strategy, business plan, financial performance and other future events. These statements include you can identify forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “believeobjective,” “projectanticipate,” “believe,” “estimate,” “maypredict,” “shouldpotential,” “anticipatecontinue” and “ongoing,” “will” or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and similar statements unknown risks, uncertainties and other important factors that may cause our actual results, levels of a future activity, performance or forward-achievements to be materially different from the information expressed or implied by these forward- looking nature identify statements. The forward-looking statements for purposes contained in this prospectus and the documents incorporated by reference into this prospectus are based upon information available to us as of the federal securities laws date of this prospectus and, while we believe such information forms a reasonable basis for such statements, such information may be limited or otherwiseincomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. All forwardForward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those statements about: • the development of our product candidates, including statements regarding the timing of initiation, completion and the outcome of clinical studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs; • our ability to advance our product candidates into, and successfully complete, clinical trials and specifically, pivotal safety and efficacy trials, including statements regarding whether or not planned trials will be considered pivotal trials by regulatory authorities; • our ability to obtain and maintain regulatory approval of our product candidates in the indications for which we plan to develop them, and any related restrictions, limitations or warnings in the label of an approved drug or therapy; • our ability to license additional intellectual property relating to our product candidates from third parties and to comply with our existing license agreement; • our plans to research, develop, manufacture and commercialize our product candidates; • the timing of our regulatory filings for our product candidates, along with regulatory developments in the United States, European Union and other foreign countries; • the size and growth potential of the markets for our product candidates, if approved, and the rate and degree of market acceptance of our product candidates, including reimbursement that may be received from payors; • our ability to raise additional capital for our operations; • our commercialization, marketing and manufacturing capabilities and strategy; • our expectations regarding our ability to obtain and maintain intellectual property protection; • our ability to attract and retain qualified employees and key personnel; • our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; • the scalability and commercial viability of our manufacturing methods and processes; • the success of competing therapies that are or may become available; • whether we are classified as a PFIC for current and future periods; • matters relating to Brexit; and • our estimates regarding future expenses, revenues and needs for additional financing and the accuracy thereof. You should refer to the important factors set forth under in the caption “Risk Factors” cautionary statements included in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis other documents incorporated herein, for a discussion of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all important factors on our business or the extent to which any factor, or combination of factors, that may cause our actual results to differ materially from those contained in any expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplementwill prove to be accurate. Furthermore, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these if our forward-looking statements publiclyprove to be inaccurate, or to update the reasons actual results could differ materially from those anticipated inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume regard these statements as a representation or warranty by us or any other person that we will achieve our silence over objectives and plans in any specified time means that actual events are bearing out as expressed frame, or implied in such at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. If one or more You should read this prospectus, any applicable prospectus supplement, any free writing prospectuses that we may authorize for use in connection with an offering and the documents that we reference in this prospectus and have filed as exhibits to the registration statement of these or other risks or uncertainties materializes, or if which this prospectus is a part completely and with the understanding that our underlying assumptions prove to be incorrect, actual future results may vary be materially different from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differexpect.
Appears in 1 contract
Samples: Open Market Sale Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and supplement, the accompanying base prospectus and the other documents we file have filed with the SEC that are incorporated herein by reference herein contain forward- looking statements that involve substantial risks and therein contain “uncertainties. All statements, other than statements of historical facts, regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans, objectives of management or other financial items are forward-looking statements. The words “anticipate,” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “believepredict,” “project,” “estimatewill,” “may,” “should,” “anticipate,” “willwould” and similar statements of a future or forward-looking nature expressions are intended to identify forward-looking statements for purposes of the federal securities laws or otherwise. All statements, although not all forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in contain these statementsidentifying words. We believe that these factors includemay not actually achieve the plans, but are not limited to, those factors set forth under the caption “Risk Factors” intentions or expectations disclosed in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement statements, and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this prospectus supplement, particularly as set forth and incorporated by reference in the “Risk Factors” section above, that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, collaborations or investments we may make. You should not assume read this prospectus supplement, the accompanying prospectus and the documents that the information contained we incorporate by reference in this prospectus supplement completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements, except as otherwise required by law. We advise you, however, to consult any further disclosures we make on related subjects in our future annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K we file with or furnish to the SEC. We intend to use the net proceeds from this offering for our planned clinical trials, preclinical programs, for other research and development activities and for general corporate purposes. Because there is accurate no minimum offering amount required as a condition to close this offering, the actual total public offering amount, commissions and proceeds to us, if any, are not determinable at this time. There can be no assurance that we will sell any shares under or fully utilize the sales agreement with the Agent as a source of financing. The amount and timing of our use of the net proceeds from any date other than offerings hereunder will depend on a number of factors, such as the timing and progress of our clinical trial efforts and pre-clinical programs. As of the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should cannot assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully specify with certainty all of the factors set forth or referred particular uses for the net proceeds to in us from this prospectus supplement and offering. Accordingly, our management will have broad discretion in the accompanying base prospectus that could cause actual timing and application of these proceeds. Pending application of the net proceeds as described above, we intend to temporarily invest the proceeds in short-term, interest-bearing instruments. We have never declared or paid any cash dividends on our capital stock, and we do not currently intend to pay any cash dividends on our common stock for the foreseeable future. We expect to retain future earnings, if any, to fund the development and growth of our business. Any future determination to pay dividends on our common stock will be at the discretion of our board of directors and will depend upon, among other factors, our results to differof operations, financial condition, capital requirements and any contractual restrictions.
Appears in 1 contract
Samples: At Market Issuance Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus supplement, and the documents we file with the SEC that are incorporated by reference herein and therein into this prospectus supplement, contain “forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include are based on our management’s current beliefs, expectations and assumptions about future events, conditions and results and on information currently available to us. Discussions containing these forward-looking statements both with respect to usmay be found, specifically, and the biotechnology sectoramong other places, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words sections titled “expectBusiness,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or forward-looking nature identify forward-looking statements for purposes of the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in incorporated by reference from our most recent Annual Report on Form 10-K and our most recent subsequent Quarterly Reports Report on Form 10-Q/10-Q/A, all of which as well as any amendments thereto, filed with the SEC. In some cases, you should review carefully. Please consider our can identify forward-looking statements in light by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “positioned,” “potential,” “seek,” “should,” “target,” “will,” “would” or the negative or plural of those risks terms, and similar expressions intended to identify statements about the future, although not all forward-looking statements contain these words. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these statements. Any statements in this prospectus supplement, or incorporated herein by reference, about our expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements include statements regarding: ● the potential to receive developmental, regulatory, and commercialization milestone and royalty payments under our Collaboration and License Agreement with X. Xxxxxxxx-Xx Xxxxx Ltd and Genentech, Inc.; ● our plans to research, develop and commercialize our product candidates; ● the initiation, progress, success, cost and timing of our clinical trials and other product development activities; ● the therapeutic potential of our product candidates, and the indications for which we intend to develop our product candidates; ● our ability to successfully manufacture our product candidates for clinical development and, if approved, for commercialization, and the timing and costs of such manufacture; ● the potential of our cell therapy platform; ● our ability to obtain additional capital to fund our operations; ● our expectations and plans regarding existing and potential future collaborations with third parties such as you read pharmaceutical and biotechnology companies, government agencies, academic laboratories, and research institutes for the discovery, development, and/or commercialization of novel cell therapy products; ● the size and growth of the potential markets for our product candidates and our ability to serve those markets; ● the potential scope and value of our intellectual property rights; and ● the effects on our operations of the Israel-Hamas war, other geopolitical conflicts, political and economic instability, public health emergencies and macroeconomic conditions. You should refer to the “Risk Factors” section in this prospectus supplement and in any free writing prospectus we authorize for use in connection with this offering, and under similar headings in the accompanying base prospectus. It is not possible other documents that are incorporated by reference into this prospectus supplement, for our management to predict all risks, nor can we assess the impact a discussion of all important factors on our business or the extent to which any factor, or combination of factors, that may cause our actual results to differ materially from those contained in any expressed or implied by our forward-looking statements. Given these risks, uncertainties and other factors, many of which are beyond our control, we cannot assure you that the forward-looking statements we may make. Given these uncertaintiesin this prospectus supplement, or incorporated by reference herein, will prove to be accurate, and you should not place undue reliance on these forward- forward-looking statements. You Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not assume regard these statements as a representation or warranty by us or any other person that the information contained we will achieve our objectives and plans in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplementspecified time frame, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by referenceat all. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these revise any forward-looking statementsstatements to reflect events or developments occurring after the date of this prospectus supplement, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differ.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and prospectus, the documents we file with the SEC that are incorporated by reference herein and therein any accompanying prospectus supplement may contain “forward-looking statements” within . These statements relate to future events or our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. All statements other than statements of historical facts are forward-looking statements. These forward- looking statements are made under the meaning of □safe harbor□ provision under Section 27A of the Securities Act, Act and Section 21E of the Securities Exchange Act of 1934, and as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology sector, defined in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words “expect,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or forward-looking nature In some cases, you can identify forward-looking statements for purposes by terminology such as □may,□ □will,□ □should,□ □expects,□ □intends,□ □plans,□ □anticipates,□ □believes,□ □estimates,□ □predicts,□ □potential,□ □continue□ or the negative of the federal securities laws these terms or otherwiseother comparable terminology. All These statements are only predictions. You should not place undue reliance on forward-looking statements because they involve inherent risks known and uncertaintiesunknown risks, uncertainties and other factors, which are, in some cases, beyond our control and which could materially affect results. You should refer to the □Risk Factors□ section of this prospectus, any accompanying prospectus supplement, and there are or will be important factors our periodic and current reports filed with the SEC for specific risks that could cause actual results to differ materially be significantly different from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such by these forward-looking statements. If one or more of these or other risks or uncertainties materializesoccur, or if our underlying assumptions prove to be incorrect, actual events or results may vary significantly from those implied or projected by the forward-looking statements. No forward- looking statement is a guarantee of future performance. Forward-looking statements speak only as of the date made and we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You should read this prospectus, any accompanying prospectus supplement and the documents that we reference in this prospectus and have filed with the SEC as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what any future results expressed or implied by these forward-looking statements. Forward-looking statements in this prospectus include, but are not limited to, statements about: • the initiation, timing, progress and results of our studies in animals and clinical trials, and our research and development programs; • our ability to advance our product candidates into, and successfully complete, clinical trials; • our reliance on the success of our clinical-stage product candidates; • the timing or likelihood of regulatory filings and approvals; • the commercialization of our product candidates, if approved; • our ability to develop sales and marketing capabilities; • the pricing and reimbursement of our product candidates, if approved; • the implementation of our business model, strategic plans for our business and technology; • the scope of protection we anticipate. All subsequent written are able to establish and oral maintain for intellectual property rights covering our product candidates and technology; • our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; • costs associated with defending intellectual property infringement, product liability and other claims; • regulatory development in the United States, China and other jurisdictions; • estimates of our expenses, future revenues, capital requirements and our needs for additional financing; • the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements; • our ability to maintain and establish collaborations or obtain additional grant funding; • the rate and degree of market acceptance of our product candidates; • developments relating to our competitors and our industry, including competing therapies; • our ability to effectively manage our anticipated growth; • our ability to attract and retain qualified employees and key personnel; • statements regarding future revenue, hiring plans, expenses, capital expenditures, capital requirements and share performance; • the future trading price of our ordinary shares and impact of securities analysts’ reports on these prices; and • other risks and uncertainties, including those listed under the caption □Risk Factors.□ The □Risk Factors□ section of this prospectus references the principal contingencies and uncertainties to which we believe we are subject, which should be considered in evaluating any forward-looking statements attributable to us contained or individuals acting on our behalf are expressly qualified in their entirety incorporated by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to reference in this prospectus supplement and or in the accompanying base any prospectus that could cause actual results to differsupplement.
Appears in 1 contract
Samples: Open Market Sale Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement prospectus, including the sections entitled “About This Prospectus,” “About CareCloud, Inc.,” “Risk Factors,” and “Use of Proceeds” as well as the accompanying base prospectus and the documents information we file with the SEC that are incorporated by reference herein from our Annual Report on Form 10-K for the year ended December 31, 2020 (filed under our former name, MTBC, Inc.) and therein other documents, contain “forward-looking statements” statements within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future eventsfederal securities laws. These statements include relate to anticipated future events, future results of operations or future financial performance. In some cases, you can identify forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words by terminology such as “expectmay,” “intendmight,” “plan,” “believe,” “project,” “estimate,” “maywill,” “should,” “anticipateintends,” “willexpects,” and similar statements “plans,” “goals,” “projects,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” or “continue” or the negative of a future these terms or forward-looking nature identify other comparable terminology. These forward-looking statements for purposes are only predictions, are uncertain and involve substantial known and unknown risks, uncertainties and other factors which may cause our (or our industry’s) actual results, levels of the federal securities laws activity or otherwise. All performance to be materially different from any future results, levels of activity or performance expressed or implied by these forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption The “Risk Factors” in section of this prospectus supplement sets forth detailed risks, uncertainties and cautionary statements regarding our business and these forward-looking statements. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all of the risks and uncertainties that could have an impact on the forward-looking statements, including without limitation, risks and uncertainties relating to: ● our ability to manage our growth, including acquiring, partnering with, and effectively integrating the acquisitions of Meridian Medical Management, CareCloud Health, Inc., fka CareCloud Corporation (a company we purchased in January 2020 and whose name we took) and other acquired businesses into our infrastructure and avoiding legal exposure and liabilities associated with acquired companies and assets; ● our ability to retain our clients and revenue levels, including effectively migrating new clients and maintaining or growing the accompanying base prospectus revenue levels of our new and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” existing clients; ● our ability to maintain operations in our most recent Annual Report on Form 10Pakistan Offices and Sri Lanka in a manner that continues to enable us to offer competitively priced products and services; ● our ability to keep pace with a rapidly changing healthcare industry; ● our ability to consistently achieve and maintain compliance with a myriad of federal, state, foreign, local, payor and industry requirements, regulations, rules, laws and contracts; ● our ability to maintain and protect the privacy of confidential and protected Company, client and patient information; ● our ability to develop new technologies, upgrade and adapt legacy and acquired technologies to work with evolving industry standards and third-K party software platforms and technologies, and protect and enforce all of these and other intellectual property rights; ● our subsequent Quarterly Reports on Form 10-Q/10-Q/Aability to attract and retain key officers and employees, and the continued involvement of Xxxxxx Xxx as Executive Chairman and X. Xxxx Xxxxxxxx as Chief Executive Officer and President, all of which you should review carefully. Please consider are critical to our forward-looking statements ongoing operations, growing our business and integrating of our newly acquired businesses; ● our ability to comply with covenants contained in light our credit agreement with our senior secured lender, Silicon Valley Bank and other future debt facilities; ● our ability to pay our monthly preferred dividends to the holders of those risks as you read this prospectus supplement our Series A Preferred Stock; ● our ability to compete with other companies developing products and selling services competitive with ours, and who may have greater resources and name recognition than we have; ● our ability to respond to the uncertainty resulting from the spread of the COVID-19 pandemic and the accompanying base prospectus. It is not possible impact it may have on our operations, the demand for our management services, and economic activity in general; and ● our ability to predict all riskskeep and increase market acceptance of our products and services. We cannot guarantee future results, nor can we assess the impact levels of all factors on our business activity or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may makeperformance. Given these uncertainties, you You should not place undue reliance on these forward- forward-looking statements. You should not assume that the information contained in this prospectus supplement is accurate , which speak only as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of this prospectus. These cautionary statements should be considered with any written or oral forward-looking statements that we may issue in the document so incorporated by referencefuture. Except as required by applicable law, including the securities laws of the U.S., we assume no obligation do not intend to update these any of the forward-looking statements publiclyto conform these statements to reflect actual results, later events or circumstances or to update reflect the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the futureoccurrence of unanticipated events. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral Our forward-looking statements attributable to us do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or individuals acting other investments or strategic transactions we may engage in. We have filed with the SEC a registration statement on our behalf are expressly qualified in their entirety by Form S-3 under the Securities Act for the securities being offered under this Noteprospectus. Before purchasing any shares This prospectus, which is part of common stockthe registration statement, you should consider carefully does not contain all of the factors information set forth in the registration statement and accompanying exhibits. This prospectus contains descriptions of certain agreements or referred documents that are exhibits to the registration statement. The statements as to the contents of such exhibits, however, are brief descriptions and are not necessarily complete, and each statement is qualified in all respects by reference to such agreement or document. In addition, we file annual, quarterly and other reports, proxy statements and other information with the SEC. The SEC maintains a website that contains reports, proxy and information statements, registration statements and other information regarding issuers that file electronically with the SEC, including our filings with the SEC. The SEC website address is xxx.xxx.xxx. We make available free of charge through our website our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, Proxy Statement on Schedule 14A and all amendments to those reports as soon as reasonably practicable after such material is electronically filed with or furnished to the SEC. Our website address is xxx.xxxxxxxxx.xxx. Please note that our website address is provided as an inactive textual reference only. Information contained on or accessible through our website is not part of this prospectus or any accompanying prospectus supplement, and is therefore not incorporated by reference unless such information is otherwise specifically referenced elsewhere in this prospectus supplement and in the or any accompanying base prospectus that could cause actual results to differsupplement.
Appears in 1 contract
Samples: At Market Issuance Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and supplement, the accompanying base prospectus and the other documents we file have filed with the SEC that are incorporated herein by reference herein contain forward-looking statements that involve substantial risks and therein contain “uncertainties. All statements, other than statements of historical facts, regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans, objectives of management or other financial items are forward-looking statements. The words “anticipate,” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “believepredict,” “project,” “estimatewill,” “may,” “should,” “anticipate,” “willwould” and similar statements of a future or forward-looking nature expressions are intended to identify forward-looking statements for purposes of the federal securities laws or otherwise. All statements, although not all forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in contain these statementsidentifying words. We believe that these factors includemay not actually achieve the plans, but are not limited to, those factors set forth under the caption “Risk Factors” intentions or expectations disclosed in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement statements, and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this prospectus supplement, particularly as set forth and incorporated by reference in the “Risk Factors” section above, that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, collaborations or investments we may make. You should not assume read this prospectus supplement, the accompanying prospectus and the documents that the information contained we incorporate by reference in this prospectus supplement is accurate completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements, except as otherwise required by law. We advise you, however, to consult any further disclosures we make on related subjects in our future annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K we file with or furnish to the SEC. We intend to use the net proceeds from this offering for working capital and general corporate purposes, including without limitation development of our product candidates and general and administrative expenses. The amounts and timing of our use of the net proceeds from the sale of securities in this offering will depend on a number of factors, such as the timing and progress of trials of our clinical and pre-clinical product candidates and our development efforts, the timing and progress of any date other than partnering efforts, technological advances and the competitive environment for our product candidates. As of the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should cannot assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully specify with certainty all of the factors set forth or referred particular uses for the net proceeds to in us from this prospectus supplement and offering. Accordingly, our management will have broad discretion in the accompanying base prospectus that could cause actual results timing and application of these proceeds. Pending application of the net proceeds as described above, we may invest the net proceeds of this offering in a variety of capital preservation investments, including but not limited to differshort-term, interest-bearing investment grade securities, money market accounts, certificates of deposit and direct or guaranteed obligations of the U.S. government.
Appears in 1 contract
Samples: At Market Issuance Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file have filed with the SEC that are incorporated by reference herein and therein contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (amended, or the “Exchange Act”). These statements relate to future events or to our future operating or financial performance and involve known and unknown risks, these uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. Forward-looking statements include, but are not limited to, statements about: • our ability to successfully develop ibrexafungerp, including an IV formulation of ibrexafungerp; • our expectations regarding the benefits we will obtain from the oral and IV form of ibrexafungerp having been designated as a QIDP; • our ability to obtain FDA approval of ibrexafungerp; • our expectations regarding the devotion of our resources; • our expected uses of the net proceeds to us from any specific offering; • the expected costs of studies and when they will begin; • our ability to scale up manufacturing to commercial scale; • our reliance on third parties to conduct our clinical studies; • our reliance on third-party contract manufacturers to manufacture and supply commercial supplies of ibrexafungerp for us; • our expectations regarding the marketing of ibrexafungerp should we receive regulatory approval; • our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing; • our financial performance; and • developments and projections relating to our competitors or our industry. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “predict,” “potential” and similar expressions intended to identify forward-looking statements. These statements reflect our current views with respect to our ongoing future events and planned clinical trials, business strategy, business plan, financial performance are based on assumptions and other future events. These statements include forward-looking statements both with respect are subject to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words “expect,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or forward-looking nature identify forward-looking statements for purposes of the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- forward-looking statements. You should not assume that We discuss in greater detail many of these risks under the information heading “Risk Factors” contained in this prospectus supplement is accurate as of any date other than the date on the front of this applicable prospectus supplement, or that in any information incorporated free writing prospectuses we may authorize for use in connection with a specific offering, and in our most recent annual report on Form 10-K and in our most recent quarterly report on Form 10-Q, as well as any amendments thereto reflected in subsequent filings with the SEC, which areincorporated by reference into this prospectus supplement is accurate in their entirety. Also, these forward-looking statements represent our estimates and assumptions only as of any date other than the date of the document so incorporated by referencecontaining the applicable statement. Except as Unless required by law, we assume undertake no obligation to update these or revise any forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if reflect new information becomes available in the futureor future events or developments. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializesYou should read this prospectus, or if any applicable prospectus supplement, together with the documents we have filed with the SEC that are incorporated by reference and any free writing prospectus that we may authorize for use in connection with this offering completely and with the understanding that our underlying assumptions prove to be incorrect, actual future results may vary be materially different from what we anticipateexpect. All subsequent written and oral We qualify all of the forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differforegoing documents by these cautionary statements.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus prospectus, and the documents we file with the SEC that are incorporated in this prospectus by reference herein and therein reference, contain “forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include are based on our management’s current beliefs, expectations and assumptions about future events, conditions and results and on information currently available to us. Discussions containing these forward-looking statements both with respect to usmay be found, specifically, and the biotechnology sectoramong other places, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words sections titled “expectBusiness,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or forward-looking nature identify forward-looking statements for purposes of the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in incorporated by reference from our most recent Annual Report on Form 10-K and our subsequent most recent Quarterly Reports Report on Form 10-Q/10Form10-Q/A, all of which as well as any amendments thereto, filed with the SEC. In some cases, you should review carefully. Please consider our can identify forward-looking statements in light by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “positioned,” “potential,” “seek,” “should,” “target,” “will,” “would” or the negative or plural of those risks as you read terms, and similar expressions intended to identify statements about the future, although not all forward-looking statements contain these words. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these statements. Any statements in this prospectus, or incorporated herein by reference, about our expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are forward-looking statements. Within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act these forward-looking statements include statements regarding: • statements regarding the impact of the COVID-19 pandemic and its effects on our operations, research and development, clinical trials and financial position, and its potential effects on the operations of third-party manufacturers, contract research organizations, other service providers, and collaborators with whom we conduct business; • our plans to develop and commercialize our product candidates; • the initiation, timing, progress and expected results of our current and future clinical trials and our research and development programs; • our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; • our ability to successfully acquire xxxx-license additional product candidates or other technology on reasonable terms; • our ability to maintain and establish collaborations or strategic relationships or obtain additional funding; • the timing and likelihood of obtaining regulatory approval of our current and future product candidates; • our expectations regarding the potential market size and the rate and degree of market acceptance of such product candidates; • our ability to fund our working capital requirements and expectations regarding the sufficiency of our capital resources; • the implementation of our business model and strategic plans for our business and product candidates; • the scope of protection we are able to establish and maintain for intellectual property rights and the duration of our patent rights covering our product candidates; • developments or disputes concerning our intellectual property or other proprietary rights; • the scalability and commercial viability of our manufacturing methods and processes; • our expectations regarding government and third-party payor coverage and reimbursement; • our ability to compete in the markets for our product candidates; • the impact of government laws and regulations; • developments relating to our competitors and our industry; • the factors that may impact our financial results; and • our expected use of proceeds from any offering under this prospectus. You should refer to the “Risk Factors” section contained in the applicable prospectus supplement and any related free writing prospectus, and under similar headings in the accompanying base other documents that are incorporated by reference into this prospectus. It is not possible , for our management to predict all risks, nor can we assess the impact a discussion of all important factors on our business or the extent to which any factor, or combination of factors, that may cause our actual results to differ materially from those contained in any expressed or implied by our forward-looking statements. Given these risks, uncertainties and other factors, many of which are beyond our control, we cannot assure you that the forward-looking statements we may make. Given these uncertaintiesin this prospectus will prove to be accurate, and you should not place undue reliance on these forward- forward-looking statements. You Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not assume regard these statements as a representation or warranty by us or any other person that the information contained we will achieve our objectives and plans in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplementspecified time frame, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by referenceat all. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these revise any forward-looking statementsstatements to reflect events or developments occurring after the date of this prospectus, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differ.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are information incorporated by reference herein and therein contain in this prospectus include “forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (amended, or the “Exchange Act”), and Section 27A of the Securities Act of 1933, as amended, or the Securities Act. For these purposes, any statements reflect contained or incorporated by reference herein regarding our current views with respect to our ongoing and planned clinical trials, business strategy, business planfuture operations, financial performance position, future revenues, projected costs, prospects, plans and objectives of management, other future eventsthan statements of historical facts, are forward-looking statements. These statements include In some cases, you can identify forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include by the words “may,” “might,” “can,” “will,” “to be,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “estimatepotential,” “maylikely,” “shouldcontinue” and “ongoing,” “anticipate,” “will” and similar or the negative of these terms, or other comparable terminology intended to identify statements of a future or forward-looking nature identify forward-about the future, although not all forward- looking statements for purposes of the federal securities laws or otherwisecontain these words. All These forward-looking statements involve inherent risks known and uncertaintiesunknown risks, uncertainties and there other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. We cannot guarantee that we actually will achieve the plans, intentions or expectations expressed or implied in our forward-looking statements. There are or will be a number of important factors that could cause actual results results, levels of activity, performance or events to differ materially from those indicated expressed or implied in these statementsthe forward-looking statements we make. We believe that these factors include, but are not limited to, those factors set forth under You should refer to the caption “Business,” “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and other sections contained in our most recent Annual Report on Form 10-K this prospectus and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this the applicable prospectus supplement and any related free writing prospectus, and under similar headings in the accompanying base prospectus. It is not possible other documents that are incorporated herein and therein by reference, for our management to predict all risks, nor can we assess the impact a discussion of all important factors on our business or the extent to which any factor, or combination of factors, that may cause our actual results to differ materially from those contained in any expressed or implied by our forward-looking statements. Given these risks, uncertainties and other factors, many of which are beyond our control, we cannot assure you that the forward-looking statements we may make. Given these uncertaintiesin this prospectus or any prospectus supplement or related free writing prospectus will prove to be accurate, and you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializesFurthermore, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable prove to us or individuals acting on our behalf are expressly qualified be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in their entirety by this Note. Before purchasing any shares of common stockthese forward- looking statements, you should consider carefully all not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified timeframe, or at all. Any forward-looking statement speaks only as of the factors set forth or referred date on which it is made. Although we may elect to in this prospectus supplement and update forward-looking statements in the accompanying base prospectus that could cause actual results future, we specifically disclaim any obligation to differdo so, except as may be required by law, even if our estimates change, and readers should not rely on our forward-looking statements as representing our views as of any date subsequent to the date the statements were made.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and supplement, the accompanying base prospectus and the documents we file with the SEC that are incorporated by reference herein and therein contain “forward-looking statements” within the meaning therein, other than statements or characterizations of Section 27A of the Securities Acthistorical fact, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include are forward-looking statements both with respect to us, specifically, and within the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions meaning of the Private Securities Litigation Reform Act of 1995. Statements that include the The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intendintends,” “may,” “might,” “plan,” “believepossible,” “potential,” “predict,” “project,” “estimate,” “may,” “should,” “anticipate,” “willwould” and similar statements of a future or forward-looking nature expressions, as they relate to us, are intended to identify forward-looking statements. These statements for purposes appear in a number of places in this prospectus supplement, the federal securities laws accompanying prospectus and the documents incorporated by reference herein and therein, and include statements regarding the intent, belief or otherwise. All forwardcurrent expectations of Eos Energy Enterprises, Inc. Forward-looking statements involve inherent risks and uncertaintiesare based on our management’s beliefs, as well as assumptions made by, and there information currently available to, them. Because such statements are or will be important factors that could cause based on expectations as to future financial and operating results and are not statements of fact, actual results to may differ materially from those indicated in these statementsprojected. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of Factors which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained current expectations include, but are not limited to: ● changes adversely affecting the business in any forward-looking statements which we may make. Given these uncertaintiesare engaged; ● our ability to forecast trends accurately; ● our ability to generate cash, you should not place undue reliance on these forward- looking statements. You should not assume that service indebtedness and incur additional indebtedness; ● our ability to raise financing in the information contained future; ● our customer’s ability to secure project financing; ● the amount of final tax credits available to our customers or to Eos Energy Enterprises, Inc. pursuant to the Inflation Reduction Act; ● uncertainties around our ability to secure conditional commitment in this prospectus supplement is accurate as a timely manner or at all, or final approval of a loan from the Department of Energy, the Loan Programs Office, or the timing of funding and the final size of any date loan if approved; ● the possibility of a government shutdown while we remain in the due diligence phase with the U.S. Department of Energy Loan Programs Office or while we await notice of a decision regarding the issuance of a loan from the Department of Energy Loan Programs Office; ● our ability to develop efficient manufacturing processes to scale and to forecast related costs and efficiencies accurately; ● fluctuations in our revenue and operating results; ● competition from existing or new competitors; ● the failure to convert firm order backlog and pipeline to revenue; ● risks associated with security breaches in our information technology systems; ● risks related to legal proceedings or claims; ● risks associated with evolving energy policies in the United States and other than countries and the date potential costs of regulatory compliance; ● risks associated with changes to U.S. trade environment; ● risks resulting from the impact of global pandemics, including the novel coronavirus, Covid-19; ● our ability to maintain the listing of our shares of common stock on NASDAQ; ● our ability to grow our business and manage growth profitably, maintain relationships with customers and suppliers and retain our management and key employees; ● risks related to adverse changes in general economic conditions, including inflationary pressures and increased interest rates; ● risk from supply chain disruptions and other impacts of geopolitical conflict; ● changes in applicable laws or regulations; ● other factors detailed under the front section entitled “Risk Factors” herein; ● other risks and uncertainties described in our Annual Report on Form 10-K for the year ended December 31, 2022 and our subsequent filings with the SEC, that we incorporate Should one or more of this prospectus supplementthese risks or uncertainties materialize or should any of our assumptions prove incorrect, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially may vary in material respects from those anticipated projected in these forward-looking statements, even if new information becomes available in . Forward-looking statements speak only as of the futuredate they are made. Thus, you should Readers are cautioned not assume that our silence over time means that actual events are bearing out as expressed or implied in such to put undue reliance on forward-looking statements. If one , and, except as required by law, the Company assumes no obligation and does not intend to update or more of revise these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us statements, whether as a result of new information, future events, or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differotherwise.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and supplement, the documents we file with the SEC that are incorporated by reference herein and therein any accompanying prospectus may contain “or incorporate forward-looking statements that are based on our management's belief and assumptions and on information currently available to our management. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements stated in or implied by these forward-looking statements” within . All statements other than statements of historical facts are forward-looking statements. These forward- looking statements are made under the meaning of safe harbor provision under Section 27A of the Securities Act, Act and Section 21E of the Securities Exchange Act of 1934, and as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology sector, defined in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words “expect,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or forward-looking nature In some cases, you can identify forward-looking statements for purposes by terminology such as may, will, should, expects, intends, plans, anticipates, believes, estimates, predicts, potential, continue or the negative of the federal securities laws these terms or otherwiseother comparable terminology. All These statements are only predictions. You should not place undue reliance on forward-looking statements because they involve inherent risks known and uncertaintiesunknown risks, uncertainties and there are or will be important factors that other factors, which are, in some cases, beyond our control and which could cause actual results materially affect results. You should refer to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in Risk Factors beginning on page S-6 of this prospectus supplement and in supplement, beginning on page 4 of the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” prospectus, in our most recent Annual Report on Form 1020-F and any updates in each report on Form 6-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/Athat indicates that it is being incorporated by reference filed with the SEC, all of which you should review carefully. Please consider our forward-looking statements in light of those for specific risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may that could cause actual results to differ materially be significantly different from those contained stated in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such by these forward-looking statements. If one or more of these or other risks or uncertainties materializesoccur, or if our underlying assumptions prove to be incorrect, actual events or results may vary materially significantly from what we anticipate. All subsequent written and oral those implied or projected by the forward-looking statements. No forward-looking statement is a guarantee of future performance. Forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all speak only as of the factors set forth date made and we undertake no obligation to publicly update or referred to revise any forward-looking statements, whether as a result of new information, future events or otherwise. You should read this prospectus, any accompanying prospectus and the documents that we reference in this prospectus supplement and have filed with the SEC as exhibits to the registration statement, of which this prospectus supplement is a part, completely and with the understanding that our actual future results may be materially different from any future results stated in or implied by these forward-looking statements. Forward-looking statements in this prospectus supplement include, but are not limited to, statements about: ■ the initiation, timing, progress and results of our studies in animals and clinical trials, and our research and development programs; ■ our ability to advance our product candidates into, and successfully complete, clinical trials; ■ our reliance on the success of our clinical-stage product candidates; ■ the timing or likelihood of regulatory filings and approvals; ■ the commercialization of our product candidates, if approved; ■ our ability to develop sales and marketing capabilities; ■ the pricing and reimbursement of our product candidates, if approved; ■ the implementation of our business model, strategic plans for our business and technology; ■ the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; ■ our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; ■ costs associated with defending intellectual property infringement, product liability and other claims; ■ regulatory development in the United States, China and other jurisdictions; ■ estimates of our expenses, future revenues, capital requirements and our needs for additional financing; ■ the potential benefits of strategic collaboration agreements and our ability to enter into strategic arrangements; ■ our ability to maintain and establish collaborations or obtain additional grant funding; ■ the rate and degree of market acceptance of our product candidates; ■ developments relating to our competitors and our industry, including competing therapies; ■ our ability to effectively manage our anticipated growth; ■ our ability to attract and retain qualified employees and key personnel; ■ our expectations regarding the period during which we qualify as an emerging growth company under the JOBS Act; ■ statements regarding future revenue, hiring plans, expenses, capital expenditures, capital requirements and share performance; ■ the future trading price of our ordinary shares and impact of securities analysts' reports on these prices; ■ the use of proceeds from this offering; and ■ other risks and uncertainties, including those listed under the caption Risk Factors in this prospectus supplement, the accompanying base prospectus that could cause actual results and our Annual Report on Form 20-F. The Risk Factors section of this prospectus supplement, the accompanying prospectus and our Annual Report on Form 20-F references the principal contingencies and uncertainties to differwhich we believe we are subject, which should be considered in evaluating any forward-looking statements contained or incorporated by reference in this prospectus supplement and the accompanying prospectus.
Appears in 1 contract
Samples: Open Market Sale Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and supplement, the accompanying base prospectus and the documents we file with the SEC that are incorporated by reference herein and therein contain “forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this prospectus supplement, the accompanying prospectus or the documents incorporated herein or therein by reference regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The words “anticipate,” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “believepredict,” “project,” “estimatewill,” “may,” “should,” “anticipate,” “willwould” and similar statements of a future or forward-looking nature expressions are intended to identify forward-looking statements for purposes of the federal securities laws or otherwise. All forward-statements, although not all forward- looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in contain these statementsidentifying words. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our The forward-looking statements in light of those risks as you read this prospectus supplement supplement, the accompanying prospectus and the accompanying base prospectus. It is not possible documents incorporated herein by reference include, among other things, statements about: • our estimates regarding expenses, future revenue, capital requirements and timing and availability of and the need for additional financing; • our management ability to predict all risksobtain and maintain regulatory approval of injectable meloxicam and our product candidates, nor can and the labeling under any approval that we assess may obtain; • the impact results, timing and outcome of all factors on our clinical trials of injectable meloxicam or our other product candidates, and any future clinical and preclinical studies; • our ability to successfully commercialize injectable meloxicam or our other product candidates, upon regulatory approval; • our ability to comply with the legal and regulatory frameworks applicable to our business or and other regulatory developments in the extent United States and foreign countries; • our ability to which raise future financing and attain profitability for continued development of our business and our product candidates and to meet required debt payments, and any factormilestone payments owing to Alkermes, or combination our other licensing and collaboration partners; • our ability to operate under increased leverage and associated lending covenants; • the performance of factorsthird-parties upon which we depend, including third-party contract research organizations, or CRO’s, and third-party suppliers and manufacturers; • our ability to obtain patent protection and defend our intellectual property rights against third parties; • our ability to maintain our relationships and contracts with our key commercial partners; • our ability to recruit or retain key scientific, technical, commercial, and management personnel or to retain our executive officers; • our ability to comply with stringent U.S. and foreign government regulation in the manufacture of pharmaceutical products, including Good Manufacturing Practice, or cGMP, compliance and U.S. Drug Enforcement Agency, or DEA, compliance; and • the effects of changes in our effective tax rate due to changes in the mix of earnings in countries with differing statutory tax rates, changes in the valuation of deferred tax assets and liabilities and changes in the tax laws. We may cause actual results to differ materially from those contained not actually achieve the plans, intentions or expectations disclosed in any our forward-looking statements we may make. Given these uncertaintiesstatements, and you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one Actual results or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary events could differ materially from what we anticipate. All subsequent written the plans, intentions and oral expectations disclosed in the forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified we make. We have included important factors in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to cautionary statements included in this prospectus supplement and in the accompanying base prospectus prospectus, particularly under “Risk Factors,” that we believe could cause actual results or events to differdiffer materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, collaborations or investments we may make. You should read this prospectus supplement, the accompanying prospectus and the documents that we incorporate by reference herein and therein completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements. We may issue and sell shares of our common stock having aggregate sale proceeds of up to $40,000,000 from time to time. Because there is no minimum offering amount required to be sold in connection with this offering, the actual total public offering amount, commissions and proceeds to us, if any, are not determinable at this time. We intend to use the net proceeds of the proposed offering for preparatory commercial and phase IIIB program activities for IV meloxicam, pipeline development activities, and general corporate purposes. These expected uses represent our intentions based upon our current plans and business conditions, which could change in the future as our plans and business conditions evolve. The amounts and timing of our actual expenditures may vary significantly depending on numerous factors, including the progress of our development, the status of and results from clinical trials, as well as any new collaborations that we may enter into with third parties for our product candidates, and any unforeseen cash needs. As a result, our management will have broad discretion in the application of the net proceeds from this offering, and investors will be relying on the judgment of our management regarding the application of the net proceeds from this offering. Pending application of the net proceeds as described above, we intend to invest the net proceeds of this offering in short-term, investment-grade, interest-bearing securities. Our common stock has been listed on The Nasdaq Capital Market under the symbol “XXXX” since our initial public offering on March 12, 2014. Prior to that time, there was no public market for our common stock. The following table sets forth the high and low sale prices per share for our common stock on The Nasdaq Capital Market for the periods indicated: HIGH LOW First Quarter $ 8.88 $ 6.80 Second Quarter $ 8.94 $ 5.81 Third Quarter $ 9.21 $ 6.68 Fourth Quarter (through December 28, 2017) $10.59 $ 8.19 First Quarter $ 9.20 $ 5.59 Second Quarter $ 8.78 $ 5.95 Third Quarter $12.50 $ 7.51 Fourth Quarter $10.17 $ 5.89 First Quarter $ 9.93 $ 2.80 Second Quarter $15.40 $ 6.56 Third Quarter $18.30 $11.06 Fourth Quarter $12.86 $ 7.58 On December 28, 2017, the closing price of our common stock as reported by The Nasdaq Capital Market was $9.45 per share. As of December 28, 2017, there were approximately 8 holders of record of our common stock. We believe that the number of beneficial owners of our common stock at that date was substantially greater. We have never declared or paid any cash dividends on our common stock and our ability to pay cash dividends is currently restricted by the terms of our credit facility with Athyrium Opportunities. We do not anticipate paying cash dividends on our common stock in the foreseeable future. Payment of future dividends, if any, on our common stock will be at the discretion of our board of directors after taking into account various factors, including our financial condition, operating results, anticipated cash needs and plans for expansion.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement, the accompanying prospectus and the documents incorporated by reference into this prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are incorporated by reference herein and therein contain “forward-looking statements” within the meaning of Section 27A of the Securities Act, Act and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forwardForward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the can be identified by words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” “project,” “estimategoal,” “strategy,” “future,” “likely,” “may,” “should,” “anticipate,” “will” and variations of these words and similar statements of a references to future or forward-looking nature identify periods, although not all forward-looking statements for purposes contain these identifying words. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the federal securities laws or otherwisefuture of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. All Because forward-looking statements involve relate to the future, they are subject to inherent risks and risks, uncertainties, and there are changes in circumstances, including but not limited to risk factors incorporated by reference under “Item 1A. Risk Factors” to Part I of our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and other factors described elsewhere in this prospectus supplement, the accompanying prospectus or in our current and future filings with the SEC. As a result, our actual results may differ materially from those expressed or forecasted in the forward-looking statements, and you should not rely on such forward-looking statements. You should carefully read this prospectus supplement and the accompanying prospectus, together with the information incorporated by reference herein and therein as described under the sections titled “Where You Can Find More Information,” completely and with the understanding that our actual future results may be materially different from what we expect. We can give no assurances that any of the events anticipated by the forward-looking statements will be important occur or, if any of them do, what impact they will have on our results of operations and financial condition. Important factors that could cause our actual results and financial condition to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements include, among others, the following: • the impact, risks and uncertainties related to COVID-19 and actions taken by governmental authorities or others in light connection therewith; • our lack of those significant revenue to date, our history of recurring operating losses and our expectation of future operating losses; • our need for substantial additional capital and our need to delay, reduce or eliminate our drug development and commercialization efforts if we are unable to raise additional capital; • the highly-competitive nature of the pharmaceutical and biotechnology industry and our ability to compete effectively; • the success of our plans to use collaboration arrangements to leverage our capabilities; • our ability to retain and attract key personnel; • the risk of misconduct of our employees, agents, consultants and commercial partners; • disruptions to our operations due to expansions of our operations; • the costs we would incur if we acquire or license technologies, resources or drug candidates; • risks as you read associated with product liability claims; • our reliance on information technology systems and the liability or interruption associated with cyber-attacks or other breaches of our systems; • our ability to use net operating loss carryforwards; • provisions in our charter documents and state law that may prevent a change in control; • work slowdown or stoppage at government agencies could negatively impact our business; • our need to complete extensive clinical trials and the risk that we may not be able to demonstrate the safety and efficacy of our drug candidates; • risks that that our clinical trials may be delayed or terminated; • our ability to obtain domestic and foreign regulatory approval for our drug candidates; • changes in existing laws and regulations affecting the healthcare industry; • our reliance on third parties to conduct clinical trials for our drug candidates; • our ability to maintain orphan drug exclusivity for our drug candidates; • our reliance on third parties for manufacturing our clinical drug supplies; • risks associated with the manufacture of our drug candidates; • our ability to establish sales and marketing capabilities relating to our drug candidates; • market acceptance of our drug candidates; • third-party payor reimbursement practices; • our ability to adequately protect the intellectual property of our drug candidates; • infringement on the intellectual property rights of third parties; • costs and time relating to litigation regarding intellectual property rights; • our ability to adequately prevent disclosure by our employees or others of trade secrets and other proprietary information; • our need to raise additional capital; • the volatility of the trading price of our common stock; • our common stock being thinly traded; • our ability to issue shares of common or preferred stock without approval from our stockholders; • our ability to pay cash dividends; • costs and expenses associated with being a public company; and • our ability to maintain compliance with the listing standards of the Nasdaq Capital Market. Any forward-looking statement made by us in this prospectus supplement supplement, the accompanying prospectus and the accompanying base prospectusdocuments incorporated by reference herein and therein is based only on information currently available to us and speaks only as of the date on which it is made. It is not possible for our management We undertake no obligation to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in publicly update any forward-looking statements we may makestatement, whether as a result of new information, future developments or otherwise. Given these uncertaintiesHowever, you should not place undue reliance on these forward- looking statements. You should not assume that carefully review the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the risk factors set forth in other reports or referred documents we file from time to in this prospectus supplement and in time with the accompanying base prospectus that could cause actual results to differSEC.
Appears in 1 contract
Samples: At the Market Offering Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement contains forward-looking statements that involve risks and uncertainties, principally in the accompanying base prospectus sections entitled “Risk Factors.” All statements other than statements of historical fact contained in this prospectus, including statements regarding future events, our future financial performance, business strategy and the documents we file with the SEC that plans and objectives of management for future operations, are incorporated by reference herein and therein contain “forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect . We have attempted to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include identify forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words by terminology including “expectanticipates,” “intendbelieves,” “plancan,” “believecontinue,” “projectcould,” “estimateestimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “should,” “anticipate,” or “will” or the negative of these terms or other comparable terminology. Although we do not make forward looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. These statements are only predictions and similar statements involve known and unknown risks, uncertainties and other factors, including the risks outlined under “Risk Factors” or elsewhere in this prospectus, which may cause our or our industry’s actual results, levels of a future activity, performance or achievements expressed or implied by these forward-looking nature identify forwardstatements. Forward-looking statements for purposes should not be read as a guarantee of future performance or results, and will not necessarily be accurate indications of the federal securities laws times at, or otherwiseby which, that performance or those results will be achieved. All forwardForward-looking statements involve inherent are based on information available at the time they are made and/or management’s good faith belief as of that time with respect to future events, and are subject to risks and uncertainties, and there are or will be important factors uncertainties that could cause actual performance or results to differ materially from those indicated what is expressed in these statements. We believe that these factors include, but are not limited to, those factors set forth under or suggested by the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements. Forward-looking statements in light speak only as of those risks as you read this prospectus supplement and the accompanying base prospectusdate they are made. It is You should not possible for our management to predict all risks, nor can we assess the impact of all factors put undue reliance on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we We assume no obligation to update these forward-looking statements publiclyto reflect actual results, changes in assumptions or changes in other factors affecting forward-looking information, except to the extent required by applicable securities laws. If we do update the reasons actual results could differ materially from those anticipated in these one or more forward-looking statements, even if new information becomes available in the future. Thus, you no inference should not assume be drawn that our silence over time means that actual events are bearing out as expressed we will make additional updates with respect to those or implied in such other forward-looking statements. If one We intend to use the net proceeds from this offering for general corporate purposes. However, our management will have broad discretion in the application of the net proceeds from this offering and could spend the proceeds in ways that do not improve our results of operations or more enhance the value of our common stock. The failure by management to apply these or other risks or uncertainties materializesfunds effectively could result in financial losses that could have a material adverse effect on our business, cause the price of our common stock to decline and delay the development of our product candidates. The offering price per share in this offering may exceed the net tangible book value per share of our common stock outstanding prior to this offering. Assuming that an aggregate of 429,162 shares of our common stock are sold at a price of $7.71 per share, the last reported sale price of our common stock on the Nasdaq Capital Market on February 25, 2021, for aggregate gross proceeds of $3,308,842, and after deducting commissions and estimated offering expenses payable by us, if you purchase common stock in this offering, you will experience immediate dilution of $6.64 per share, representing the difference between our as adjusted net tangible book value per share as of September 30, 2020 after giving effect to this offering and the assumed offering price. The exercise of outstanding stock options and warrants, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares the conversion of outstanding preferred stock into common stock, you should consider carefully all will result in further dilution of your investment. See the section entitled “Dilution” below for a more detailed illustration of the factors set forth or referred to dilution you would incur if you participate in this prospectus supplement and offering. In order to raise additional capital, we may in the accompanying base prospectus future offer additional shares of our common stock or other securities convertible into or exchangeable for our common stock at prices that may not be the same as the price per share in this offering. We may sell shares or other securities in any other offering at a price per share that is less than the price per share paid by investors in this offering, and investors purchasing shares or other securities in the future could cause actual results have rights superior to differexisting stockholders. The price per share at which we sell additional shares of our common stock, or securities convertible or exchangeable into common stock, in future transactions may be higher or lower than the price per share paid by investors in this offering. Investors who purchase shares in this offering at different times will likely pay different prices, and so may experience different outcomes in their investment results. We will have discretion, subject to market demand, to vary the timing, prices and numbers of shares sold, and there is no minimum or maximum sales price. Investors may experience a decline in the value of their shares as a result of share sales made at prices lower than the prices they paid. Subject to certain limitations in the sales agreement and compliance with applicable law, we have the discretion to deliver a sales notice to Xxxxxxxxxx at any time throughout the term of the sales agreement. The number of shares that are sold by Xxxxxxxxxx after we deliver a sales notice will fluctuate based on the market price of the common stock during the sales period and limits we set with Xxxxxxxxxx. Because the price per share of each share sold will fluctuate based on the market price of our common stock during the sales period, it is not possible at this stage to predict the number of shares that will be ultimately issued.
Appears in 1 contract
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus, including the documents that we incorporate by reference herein, contains, and any applicable prospectus supplement and the accompanying base or free writing prospectus and including the documents we file with the SEC that are incorporated incorporate by reference herein and therein contain “may contains forward-looking statements” statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (amended, or the “Exchange Act”), about us and our industry that involve substantial risks and uncertainties. All statements, other than statements of historical facts contained in this prospectus, including statements regarding our future financial condition, business strategy and plans, and objectives of management for future operations, are forward-looking statements. In some cases you can identify these statements by forward-looking words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "could," "would," "project," "plan," "expect" or the negative or plural of these words or similar expressions. These forward-looking statements include, but are not limited to, statements concerning the following: • our business and scientific strategies; • the progress of our and our collaborators' product development programs, including clinical testing, and the timing of results thereof; • our corporate collaborations and revenues that may be received from our collaborations and the timing of those potential payments; • our expectations with respect to regulatory submissions and approvals; • our drug discovery technologies; • our research and development expenses; • protection of our intellectual property; • sufficiency of our cash and capital resources and the length of time before which we will require additional funding; and • our operations and legal risks. These statements reflect our current views with respect to our ongoing future events and planned clinical trials, business strategy, business plan, financial performance are based on assumptions and other future events. These statements include forward-looking statements both with respect are subject to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words “expect,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or forward-looking nature identify forward-looking statements for purposes of the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- forward-looking statements. You should not assume that We discuss in greater detail many of these risks under the information heading "Risk Factors" contained in this prospectus supplement is accurate as of any date other than the date on the front of this applicable prospectus supplement, or that in any information free writing prospectuses we may authorize for use in connection with a specific offering, and in our most recent annual report on Form 10-K and in our most recent quarterly report on Form 10-Q, as well as any amendments thereto reflected in subsequent filings with the SEC, which are incorporated by reference into this prospectus supplement is accurate in their entirety. Also, these forward-looking statements represent our estimates and assumptions only as of any date other than the date of the document so incorporated by referencecontaining the applicable statement. Except as Unless required by law, we assume undertake no obligation to update these or revise any forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if reflect new information becomes available in the futureor future events or developments. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializesYou should read this prospectus, or if any applicable prospectus supplement, together with the documents we have filed with the SEC that are incorporated by reference and any free writing prospectus that we may authorize for use in connection with this offering completely and with the understanding that our underlying assumptions prove to be incorrect, actual future results may vary be materially different from what we anticipateexpect. All subsequent written and oral We qualify all of the forward-looking statements attributable in the foregoing documents by these cautionary statements. Except as described in any applicable prospectus supplement or in any free writing prospectuses we have authorized for use in connection with a specific offering, we currently intend to use the net proceeds from the sale of the securities offered by us or individuals acting hereunder, if any, for working capital and general corporate purposes, including research and development expenses, and selling, general and administrative expenses. The amounts and timing of our use of the net proceeds from this offering will depend on a number of factors, such as the timing and progress of our behalf are expressly qualified in their entirety by research and development efforts, the timing and progress of any partnering and commercialization efforts, technological advances and the competitive environment for our product. As of the date of this Note. Before purchasing any shares of common stockprospectus, you should consider carefully we cannot specify with certainty all of the factors set forth or referred particular uses for the net proceeds to in this prospectus supplement and us from the sale of the securities offered by us hereunder. Accordingly, our management will have broad discretion in the accompanying base prospectus that could cause actual results timing and application of these proceeds. Pending application of the net proceeds as described above, we intend to differ.temporarily invest the proceeds in short-term, interest-bearing instruments. The following table sets forth, for each of the periods presented, our deficiency of earnings to cover fixed charges. Our earnings were insufficient to cover fixed charges for the years ended December 31, 2017, 2016, 2015, 2014 and 2013. Ratio of earnings to fixed charges(1) - - - - - Deficiency of earnings available to cover fixed charges(2) (77,992) $ (69,216) $ (51,464) $ (90,908) $ (89,027)
Appears in 1 contract
Samples: Open Market Sale Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file have filed with the SEC that are incorporated by reference herein and therein contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (amended, or the “Exchange Act”). These statements relate to future events or to our future operating or financial performance and involve known and unknown risks, these uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. Forward-looking statements include, but are not limited to, statements about: • our ability to successfully develop ibrexafungerp, including an IV formulation of ibrexafungerp; • our expectations regarding the benefits we will obtain from the oral and IV form of ibrexafungerp having been designated as a QIDP; • our ability to obtain FDA approval of ibrexafungerp; • our expectations regarding the devotion of our resources; • our expected uses of the net proceeds to us from this offering; • the expected costs of studies and when they will begin; • our ability to scale up manufacturing to commercial scale; • our reliance on third parties to conduct our clinical studies; • our reliance on third-party contract manufacturers to manufacture and supply commercial supplies of ibrexafungerp for us; • our expectations regarding the marketing of ibrexafungerp should we receive regulatory approval; • our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing; • our financial performance; and • developments and projections relating to our competitors or our industry. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “predict,” “potential” and similar expressions intended to identify forward-looking statements. These statements reflect our current views with respect to our ongoing future events and planned clinical trials, business strategy, business plan, financial performance are based on assumptions and other future events. These statements include forward-looking statements both with respect are subject to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words “expect,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or forward-looking nature identify forward-looking statements for purposes of the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- forward-looking statements. You should not assume that We discuss in greater detail many of these risks under the information heading “Risk Factors” contained in this prospectus supplement is accurate prospectus, in any free writing prospectuses we may authorize for use in connection with this offering, and in our most recent annual report on Form 10-K and in our subsequent quarterly reports on Form 10-Q, as of well as any date other than amendments thereto reflected in subsequent filings with the date on the front of this prospectus supplementSEC, or that any information which are incorporated by reference into this prospectus supplement is accurate in their entirety. Also, these forward-looking statements represent our estimates and assumptions only as of any date other than the date of the document so incorporated by referencecontaining the applicable statement. Except as Unless required by law, we assume undertake no obligation to update these or revise any forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if reflect new information becomes available in the futureor future events or developments. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if You should read this prospectus together with the documents we have filed with the SEC that are incorporated by reference and any free writing prospectus that we may authorize for use in connection with this offering completely and with the understanding that our underlying assumptions prove to be incorrect, actual future results may vary be materially different from what we anticipateexpect. All subsequent written and oral We qualify all of the forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differforegoing documents by these cautionary statements.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file with the SEC contains statements that are incorporated by reference herein and therein contain “constitute forward-looking statements” within the meaning . All statements other than statements of Section 27A historical facts contained in this prospectus supplement, including statements regarding our future results of the Securities Actoperations and financial position, and Section 21E of the Securities Exchange Act of 1934business strategy, as amended (the “Exchange Act”)product candidates, these statements reflect our current views with respect to our product pipeline, ongoing and planned clinical trialsstudies, business strategyincluding those of our collaboration partners, business planregulatory approvals, financial performance research and other development costs, timing and likelihood of success, as well as plans and objectives of management for future eventsoperations are forward-looking statements. These statements include Many of the forward-looking statements both with respect to us, specifically, and contained in this prospectus supplement can be identified by the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions use of the Private Securities Litigation Reform Act of 1995. Statements that include the forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or forward-looking nature identify forward“potential,” among others. Forward-looking statements for purposes appear in a number of the federal securities laws or otherwise. All forward-looking statements involve inherent risks places in this prospectus supplement and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions, and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those factors set forth expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those identified under the caption “Risk Factors” in this prospectus supplement supplement. These risks and uncertainties include factors relating to: · the success of our and our collaboration partners’ clinical studies, and our and their ability to obtain and maintain regulatory approval and to commercialize ACI-35, semorinemab, Morphomer Tau, ACI-24 for Alzheimer’s disease (AD) and for Down syndrome-related AD (ACI-24 for DS), crenezumab, and PI-2620, our Tau-positron emission tomography (PET) imaging tracer and to a lesser extent our preclinical candidates; · the preclinical and clinical safety, efficacy and utility of our product candidates; · the ability of our competitors to discover, develop or commercialize competing products before or more successfully than we do; · our plans to research, develop and commercialize our product candidates; · the identification of serious adverse, undesirable or unacceptable side effects related to our product candidates; · our ability to maintain our current strategic relationships with our collaboration partners; · our ability to protect and maintain our, and not infringe on third parties’, intellectual property rights throughout the world; · our ability to raise capital when needed in order to continue our product development programs or commercialization efforts; · our ability to attract and retain qualified employees and key personnel; · the acceptance by the Food and Drug Administration (FDA) and applicable foreign regulatory authorities of data from studies that we and our collaboration partners conduct within and outside the US now and in the accompanying base prospectus future; · our foreign private issuer status, the loss of which would require us to comply with the Exchange Act’s domestic reporting regime, and cause us to incur significant legal, accounting and other expenses; · our incorporation in Switzerland, the laws of which govern our corporate affairs and may differ from those applicable to companies incorporated in the US; and · The other risk factors discussed under the captions “Risk Factors,.” These forward-looking statements speak only as of the date of this prospectus supplement and are subject to a number of risks, uncertainties and assumptions described under the sections in this prospectus supplement entitled “Business,Risk Factors” and “Management’s Discussion elsewhere in this prospectus supplement. Because forward-looking statements are inherently subject to risks and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/Auncertainties, all some of which cannot be predicted or quantified and some of which are beyond our control, you should review carefullynot rely on these forward-looking statements as predictions of future events. Please consider The events and circumstances reflected in our forward-looking statements in light of those risks as you read this prospectus supplement may not be achieved or occur and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available projected in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time such as the global pandemic originating with Covid-19, and it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral revise any forward-looking statements attributable to us contained herein, whether as a result of any new information, future events, changed circumstances or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differotherwise.
Appears in 1 contract
Samples: Open Market Sale Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and prospectus, including the documents that we file with the SEC that are incorporated incorporate by reference herein and therein contain “forward-reference, contains forward- looking statements” statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (amended, or the “Exchange Act”). Any statements about our expectations, these statements reflect our current views with respect to our ongoing beliefs, plans, objectives, assumptions or future events or performance are not historical facts and planned clinical trials, business strategy, business plan, financial performance and other future eventsmay be forward-looking. These statements include forward-looking statements both with respect to usare often, specificallybut are not always, and made through the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions use of the Private Securities Litigation Reform Act of 1995. Statements that include the words or phrases such as “expectmay,” “intendwill,” “plan,” “believe,” “project,” “estimate,” “maycould,” “should,” “anticipateexpects,” “willintends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “continue,” and similar statements expressions, or the negative of a future these terms, or forward-looking nature identify forward-looking statements for purposes of the federal securities laws or otherwisesimilar expressions. All forward-looking Accordingly, these statements involve inherent estimates, assumptions, risks and uncertainties, and there are or will be important factors that uncertainties which could cause actual results to differ materially from those indicated expressed in them. Any forward-looking statements are qualified in their entirety by reference to the factors discussed throughout this prospectus supplement, and in particular those factors referenced in the section “Risk Factors.” This prospectus supplement and the accompanying prospectus, including the documents that we incorporate by reference, contain forward-looking statements that are based on our management’s belief and assumptions and on information currently available to our management. These statements relate to future events or our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We believe that these factors Forward-looking statements include, but are not limited to, statements about: • the timing, progress and results of preclinical studies and clinical trials for our current product candidates and other product candidates we may develop, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, and our research and development programs; • the timing, scope or likelihood of regulatory filings and approvals, including timing of Investigational New Drug application and Biological Licensing Application filings for, and final U.S. Food and Drug Administration approval of our current product candidates and any other future product candidates; • the timing, scope or likelihood of foreign regulatory filings and approvals; • our ability to use our understanding of the tumor microenvironment to identify product candidates and to match immunotherapies to select patient subsets; • our ability to develop and advance our current product candidates and programs into, and successfully complete, clinical studies; • our ability to develop combination therapies, whether on our own or in collaboration with Novartis and other third parties; • the impact of COVID-19 on our business operations and that of our third-party manufacturers and suppliers; • our manufacturing, commercialization and marketing capabilities and strategy; • the pricing and reimbursement of our current product candidates and other product candidates we may develop, if approved; • the rate and degree of market acceptance and clinical utility of our current product candidates and other product candidates we may develop; • the potential benefits of and our ability to maintain our collaboration with Novartis, and establish or maintain future collaborations or strategic relationships or obtain additional funding; • our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals; • our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering our current product candidates and other product candidates we may develop, the validity of intellectual property rights held by third parties, and our ability not to infringe, misappropriate or otherwise violate any third-party intellectual property rights; • our competitive position, and developments and projections relating to our competitors and our industry; • our expectations related to the use of our existing cash, cash equivalents and marketable securities; • our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; • the impact of laws and regulations; and • our expectations related to the use of proceeds from this offering. This prospectus supplement, the accompanying prospectus and the documents incorporated by reference also contain estimates, projections and other information concerning our industry, our business, and the markets for certain diseases, including data regarding the estimated size of those factors set forth under markets, and the caption “Risk Factors” incidence and prevalence of certain medical conditions. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources. You should read this prospectus supplement and in supplement, the accompanying base prospectus and under the captions “Risk Factors,” “Business,” documents that we incorporate by reference herein and “Management’s Discussion therein completely and Analysis of Financial Condition and Results of Operations,” in with the understanding that our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefullyactual future results may be materially different from what we expect. Please consider our The forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated the accompanying prospectus and the documents we incorporate by reference into this prospectus supplement is accurate herein and therein represent our views as of any date other than the date of the document so incorporated by referencetheir respective dates. Except as required by lawWe anticipate that subsequent events and developments will cause our views to change. However, while we assume no obligation may elect to update these forward-looking statements publiclyat some point in the future, or we have no current intention of doing so except to update the reasons actual results could differ materially from those anticipated in extent required by applicable law. You should, therefore, not rely on these forward-looking statements, even if new information becomes available in statements as representing our views as of any date subsequent to the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more date of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differsupplement.
Appears in 1 contract
Samples: Capital on Demand Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement supplement, the accompanying prospectus, and the accompanying base prospectus and the documents we file with the SEC that are information incorporated by reference herein and therein and any free writing prospectus that we have authorized for use in connection with this offering contain or may include “forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (amended, or the “Exchange Act”), and Section 27A of the Securities Act of 1933, as amended, or the Securities Act. For these purposes, any statements reflect contained or incorporated by reference herein regarding our current views with respect to our ongoing and planned clinical trials, business strategy, business planfuture operations, financial performance position, future revenues, projected costs, prospects, plans and objectives of management, other future eventsthan statements of historical facts, are forward-looking statements. These statements include In some cases, forward-looking statements both with respect to us, specifically, and can be identified by the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions use of the Private Securities Litigation Reform Act of 1995. Statements that include the forward-looking words such as “expectbelieves,” “intend,” “plan,” “believe,” “project,” “estimateexpects,” “may,” “will,” “plans,” “intends,” “estimates,” “could,” “should,” “anticipatewould,” “willcontinue,” “seeks,” “aims,” “projects,” “predicts,” “pro forma,” “anticipates,” “potential” or other similar words (including their use in the negative), or by discussions of future matters such as: the development of product candidates or products; timing and similar success of trial results and regulatory review; potential attributes and benefits of product candidates; the expansion of our drug portfolio; strategic alternatives for Millipred®; and other statements that are not historical. These statements are based upon the current beliefs and expectations of a future or forward-looking nature identify our management but are subject to significant risks and uncertainties, including: • drug development and manufacturing costs, timing and other risks, including reliance on investigators and enrollment of patients in clinical trials, which might be slowed by the COVID-19 pandemic and competition; • regulatory risks; • our debt and cash position and the potential need for us to raise additional capital; • general economic and market risks and uncertainties, including those caused by the COVID-19 pandemic; and • those other risks detailed in our filings with the SEC. We have based these forward-looking statements for purposes largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of the federal securities laws or otherwiseoperations, business strategy, short-term and long-term business operations and objectives, and financial needs. All These forward-looking statements involve inherent risks are subject to a number of risks, uncertainties and uncertaintiesassumptions, and there are or will be important factors that could cause actual results to differ materially from including those indicated in these statements. We believe that these factors include, but are not limited todescribed above, those factors set forth under the caption described in “Risk Factorscritical accounting estimates” described in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Part II, Item 7. "Management’s 's Discussion and Analysis of Financial Condition and Results of Operations,” in -Application of Critical Accounting Estimates" of our most recent annual report filed on Form 10-K, and those described below under the heading “Risk Factors” and under similar headings in other documents, including in our Annual Report on Form 10-K and for the year ended December 31, 2020, our subsequent Quarterly Reports Report on Form 10-Q/10-Q/AQ for the quarter ended March 31, all of which you should review carefully. Please consider our forward-looking statements 2021 and in light of those risks as you read other filings with the SEC, that are incorporated by reference in this prospectus supplement and the accompanying base prospectus. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given In light of these uncertaintiesrisks, you should not place undue reliance on these forward- looking statements. You should not assume that uncertainties and assumptions, the information contained future events and trends discussed in this prospectus supplement is accurate as of any date other than the date on the front of this and accompanying prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. We undertake no obligation to revise or publicly release the results of any revision to these forward-looking statements, even if new information becomes available in the futureexcept as required by law. ThusGiven these risks and uncertainties, you should readers are cautioned not assume that our silence over time means that actual events are bearing out as expressed or implied in to place undue reliance on such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differcautionary statement.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus, any prospectus supplement and the accompanying base prospectus and supplement, the documents we file with the SEC that are incorporated by reference herein and therein and any related free writing prospectuses issued by us may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect about our financial condition, results of operations, plans, objectives, future performance and business. Statements preceded by, followed by or that include words such as “expects,” “anticipates,” “estimates,” “projects,” “intends,” “plans,” “believes,” “predicts,” “should,” “will,” “could,” “would,” “may,” “forecast,” or similar expressions are intended to us, specifically, and identify some of the biotechnology sector, in general. We make these forward-looking statements pursuant to within the safe harbor provisions meaning of the Private Securities Litigation Reform Act of 19951995 and are included, along with this statement, for purposes of complying with the safe harbor provisions of that Act. Statements that include the words “expect,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements The realization of a future or matters expressed in forward-looking nature identify statements involves risks and uncertainties. Our actual results may differ materially from those contemplated by the forward-looking statements due to, among other factors, the risks and uncertainties described in or incorporated by reference into this prospectus, including under “Risk Factors.” Any forward-looking statement contained in this prospectus and any prospectus supplement and the documents incorporated by reference herein and xxxxxxx speaks only as of the date on which the statement was made, and we undertake no obligation to update publicly or revise any forward-looking statements for purposes any reason, whether as a result of the federal securities laws new information, future events or otherwise. All forward-looking statements involve inherent New risks and uncertaintiesemerge from time to time, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are we cannot limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, predict all of which you should review carefully. Please consider our forward-looking statements in light of those the risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the that may impact of all factors on our business or the extent to which any factorparticular risk, or combination of factorsrisks, may cause actual results to differ materially from those contained in any forward-looking statements we may makestatement. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that Our ratio of earnings to fixed charges for each of the information contained five most recently completed fiscal years and any required interim periods will be specified in this a prospectus supplement is accurate as of any date other than or in a document that we file with the date on the front of this prospectus supplement, or that any information incorporated SEC and incorporate by reference into this prospectus supplement is accurate as pertaining to the issuance, if any, by us of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available debt securities in the future. ThusUnless otherwise provided in the applicable prospectus supplement, you should not assume that our silence over time means that actual events are bearing out as expressed or implied we currently intend to use the net proceeds from the sale of the securities from offerings under this prospectus for project development, project financing, working capital support and general corporate purposes. Our management will have broad discretion in such forward-looking statements. If one or more the allocation of the net proceeds of these or other risks or uncertainties materializesofferings for any purpose, or if and investors will be relying on the judgment of our underlying assumptions prove management with regard to the use of these net proceeds. We may set forth additional information on the use of proceeds from the sale of securities that we offer under this prospectus in a prospectus supplement relating to the specific offering. We have not determined the amount of net proceeds to be incorrect, actual results used specifically for the foregoing purposes. We may vary materially from what invest the net proceeds temporarily until we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in use them for their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differstated purpose.
Appears in 1 contract
Samples: At Market Issuance Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are information incorporated by reference herein and therein in this prospectus contain “forward-looking statements” within the meaning of Section 27A the federal securities laws, which statements involve substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this prospectus and the Securities Actinformation incorporated by reference in this prospectus, including statements concerning our plans, objectives, goals, strategies, future events, future revenues or performance, financing needs, plans or intentions relating to products and markets, and Section 21E business trends and other information are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan,” “anticipate,” “target,” “forecast” or the negative of the Securities Exchange Act of 1934these terms, as amended (the “Exchange Act”)and similar expressions intended to identify forward- looking statements. Forward-looking statements are not historical facts, these statements and reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include Given the significant uncertainties, you should not place undue reliance on these forward-looking statements both with respect to usstatements. There are a number of risks, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words “expect,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or forward-looking nature identify forward-looking statements for purposes of the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there are or will be important other factors that could cause our actual results to differ materially from those indicated the forward- looking statements expressed or implied in these statementsthis prospectus and the information incorporated by reference in this prospectus. We believe that these Such risks, uncertainties, and other factors include, but are not limited toamong others, the following risks, uncertainties, and factors: • our ability to effectively implement the strategic transformation of our business; • the recent and ongoing COVID-19 pandemic; • our ability to develop and commercialize molecular testing products as well as innovate in the field of precision medicine; • the size and growth potential of the markets for our products and product candidates, and our ability to serve those markets; • the rate and degree of market acceptance and clinical utility of our products and product candidates, if approved; • coverage and reimbursement for our products and product candidates; • the performance of third parties in connection with the development of our products and product candidates, including third-party suppliers; • regulatory developments in the United States and foreign countries; • our ability to obtain and maintain regulatory approval or clearance of our products and product candidates on expected timelines; • our ability to improve and enhance our current products and product candidates; • our plans to research, develop, and commercialize new products and product candidates; • the development, regulatory approval, efficacy, and commercialization of competing products; • the outcome of pending investigations and legal proceedings; • the loss or retirement of key scientific or management personnel; • our ability to develop and maintain our corporate infrastructure, including maintaining effective internal control; • our estimates regarding expenses, future revenue, capital requirements, and needs for additional financing; • our expectations regarding our ability to obtain and maintain intellectual property protection for our products, as well as our ability to operate our business without infringing the intellectual property rights of others; and • those risk factors set forth under identified in this prospectus and the caption documents incorporated by reference herein. There may be other factors that cause our actual results to differ materially from the forward-looking statements expressed or implied in this prospectus and the information incorporated by reference in this prospectus, including factors disclosed in the sections entitled “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, elsewhere. You should evaluate all of which you should review carefully. Please consider our forward-looking statements made in light of those risks as you read this prospectus supplement and the accompanying base prospectusinformation incorporated by reference in this prospectus in the context of these risks and uncertainties. We caution you that the risks, uncertainties and other factors referred to above and elsewhere in this prospectus and the information incorporated by reference in this prospectus may not contain all of the risks, uncertainties, and other factors that may affect our future results and operations. Moreover, new risks will emerge from time to time. It is not possible for our management to predict all risks. In addition, nor can we assess cannot assure you that we will realize the impact of all factors on results, benefits, or developments that we expect or anticipate or, even if substantially realized, that they will result in the consequences or affect us or our business or in the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any way expected. All forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than and the date on the front of this prospectus supplement, or that any information incorporated by reference into in this prospectus supplement is accurate apply only as of any date other than the date of made and are expressly qualified in their entirety by the document so cautionary statements included in this prospectus and the information incorporated by referencereference in this prospectus. Except as required by law, we assume no obligation disclaim any intent to publicly update these or revise any forward-looking statements publicly, to reflect subsequent events or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available circumstances. We are a biotechnology company innovating in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more fields of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written gastrointestinal health and oral forwardbiotherapeutics. We apply a multi-looking statements attributable omics approach, combining genomics, epigenomics, proteomics, and metabolomics, to us the development of a suite of investigational ingestible devices and drug/device combinations designed to provide precise diagnostic sampling and drug delivery solutions. Our vision is to transform healthcare to become more precise and personal by improving the diagnoses of disease and improving patient outcomes through localized treatment with targeted therapies. We were incorporated in Delaware in January 2012 under the name Ascendant MDx, Inc., and we later changed our name in August 2013 to Progenity, Inc. Through our predecessor, Ascendant MDx, a California corporation, we commenced our operations in 2010. Our principal executive offices are located at 0000 Xx Xxxxx Xxxxxxx Xxxxx, Xxxxx 000, Xxx Xxxxx, XX 00000, and our telephone number is (000) 000-0000. Our website is xxx.xxxxxxxxx.xxx. Information contained on or individuals acting on accessible through our behalf are expressly qualified in their entirety by website is not a part of this Note. Before purchasing any shares prospectus, and the inclusion of common stock, you should consider carefully all of the factors set forth or referred to our website address in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differis an inactive textual reference only.
Appears in 1 contract
Samples: At Market Issuance Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and supplement, the accompanying base prospectus and the documents we file with the SEC that are incorporated by reference herein and therein contain “forward-forward- looking statements” within the meaning of Section 27A of the Securities Act, Act and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that may include the words terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “believepredict,” “projectpotential,” “estimatepositioned,” “mayseek,” “should,” “anticipatetarget,” “will,” “would,” and other similar statements expressions that are predictions of a or indicate future events and future trends, or forward-looking nature identify the negative of these terms or comparable terminology. These forward-looking statements for purposes of the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, statements regarding future operating results, potential risks pertaining to these future operating results, future plans or prospects, anticipated benefits of proposed (or future) acquisitions, dispositions and new facilities, growth, the capabilities and capacities of business operations, the remediation of the material weakness in our internal control over financial reporting, any financial or other guidance, expected capital expenditures and all statements that are not based on historical fact, but rather reflect our current expectations concerning future results and events. These forward-looking statements are based on management’s current expectations, estimates, forecasts, and projections about our business and the industry in which we operate, as well as the economy, trends and other future conditions, are subject to significant risks and uncertainties, and are subject to change based on various factors, some of which are beyond our control. Therefore, we can give no assurance that the results implied by these forward-looking statements will be realized. Furthermore, the inclusion of forward-looking statements should not be regarded as a representation by the Company or any other person that future events, plans or expectations contemplated by the Company will be achieved. The following important factors, among others, could affect future results and events, causing those factors set forth results and events to differ materially from those expressed or implied in our forward-looking statements: • our ability to achieve profitability, and to maintain profitability, in the future; • high volatility in the value attributable to our business; • the rapidly changing regulatory and legal environment in which we operate, which may lead to unknown future challenges to operating our business or which may subject our business to added costs and/or uncertainty regarding our ability to operate; • the availability of financing opportunities, risks associated with economic conditions, dependence on management and conflicts of interest; • economic dependence on regulated terms of service and power rates; • dependency on continued growth in blockchain and bitcoin usage; • our ability to keep pace with technology changes and competitive conditions; • security and cybersecurity threats and hacks; • dependency on third parties to maintain our cold and hot wallets that hold our bitcoin; • changes to bitcoin mining difficulty; • our reliance on a limited number of key employees; • changes in network and infrastructure; • our ability to successfully integrate our newly acquired operations; • our ability to execute on our business strategy; • our ability to remediate the material weakness identified in our internal control over financial reporting in our Annual Report on Form 10-K for the fiscal year ended September 30, 2023; • our ability to resolve open comments from the SEC on our public filings and any changes to our disclosures as a result of the resolution of such matters; • risks relating to our potential establishment of an in-house function to trade bitcoin for our own account on the bitcoin we have mined, and hedge risk relating to our bitcoin holdings; and • other risks and uncertainties discussed under the caption “Risk Factors” in this prospectus supplement and documents incorporated by reference in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all For information about the risks, nor can we assess the impact of all uncertainties and factors on our business that could cause future results or the extent to which any factor, or combination of factors, may cause actual results events to differ materially from those expressed or implied in our forward-looking statements, please review the disclosure contained in any this prospectus supplement, and in the accompanying prospectus and our other filings made with the SEC. Potential investors are urged to consider these factors carefully in evaluating the forward-looking statements we may make. Given these uncertainties, you should and to not place undue reliance on these forward- any forward-looking statements. You should not assume that the Any forward-looking statement or information contained in this prospectus supplement is accurate speaks only as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by referenceon which it is made. Except as expressly required by lawunder federal securities laws and the rules and regulations of the SEC, we assume no expressly disclaim any intent or obligation to update or revise these forward-looking statements publiclyfor any reason, whether written or oral, that may be made from time to update time, whether as a result of new information, future events or changed circumstances or for any other reason after the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in date of such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differ.
Appears in 1 contract
Samples: At the Market Offering Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and supplement, as well as the accompanying base prospectus and the documents information we file with the SEC that are incorporated by reference herein from our Annual Report on Form 10-K for the year ended December 31, 2020 (filed under our former name, MTBC, Inc.) and therein other documents and reports, contain “forward-looking statements” statements within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future eventsfederal securities laws. These statements include relate to anticipated future events, future results of operations or future financial performance. In some cases, you can identify forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words by terminology such as “expectmay,” “intendmight,” “plan,” “believe,” “project,” “estimate,” “maywill,” “should,” “anticipateintends,” “willexpects,” and similar statements “plans,” “goals,” “projects,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” or “continue” or the negative of a future these terms or forward-looking nature identify other comparable terminology. These forward-looking statements for purposes are only predictions, are uncertain and involve substantial known and unknown risks, uncertainties and other factors which may cause our (or our industry’s) actual results, levels of the federal securities laws activity or otherwise. All performance to be materially different from any future results, levels of activity or performance expressed or implied by these forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption The “Risk Factors” in section of this prospectus supplement sets forth detailed risks, uncertainties and in cautionary statements regarding our business and these forward-looking statements. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all of the accompanying base prospectus risks and under uncertainties that could have an impact on the captions “Risk Factors,” “Business,” forward-looking statements, including without limitation, risks and “Management’s Discussion uncertainties relating to: ● our ability to manage our growth, including acquiring, partnering with, and Analysis effectively integrating acquired businesses into our infrastructure and avoiding legal exposure and liabilities associated with acquired companies and assets; ● our ability to retain our clients and revenue levels, including effectively migrating new clients and maintaining or growing the revenue levels of Financial Condition our new and Results of Operations,” existing clients; ● our ability to maintain operations in our most recent Annual Report on Form 10offshore offices in a manner that continues to enable us to offer competitively priced products and services; ● our ability to keep pace with a rapidly changing healthcare industry; ● our ability to consistently achieve and maintain compliance with a myriad of federal, state, foreign, local, payor and industry requirements, regulations, rules, laws and contracts; ● our ability to maintain and protect the privacy of confidential and protected Company, client and patient information; ● our ability to develop new technologies, upgrade and adapt legacy and acquired technologies to work with evolving industry standards and third-K party software platforms and technologies, and protect and enforce all of these and other intellectual property rights; ● our subsequent Quarterly Reports on Form 10-Q/10-Q/Aability to attract and retain key officers and employees, and the continued involvement of Xxxxxx Xxx as Executive Chairman and X. Xxxx Xxxxxxxx as Chief Executive Officer and President, all of which you should review carefully. Please consider are critical to our forward-looking statements ongoing operations, growing our business and integrating of our newly acquired businesses; ● our ability to comply with covenants contained in light our credit agreement with our senior secured lender, Silicon Valley Bank and other future debt facilities; ● our ability to pay our monthly preferred dividends to the holders of those risks as you read this prospectus supplement our preferred stock; ● our ability to compete with other companies developing products and selling services competitive with ours, and who may have greater resources and name recognition than we have; ● our ability to respond to the uncertainty resulting from the spread of the COVID-19 pandemic and the accompanying base prospectus. It is not possible impact it may have on our operations, the demand for our management services, and economic activity in general; and ● our ability to predict all riskskeep and increase market acceptance of our products and services. We cannot guarantee future results, nor can we assess the impact levels of all factors on our business activity or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may makeperformance. Given these uncertainties, you You should not place undue reliance on these forward- forward-looking statements. You should not assume that the information contained in this prospectus supplement is accurate , which speak only as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of this prospectus. These cautionary statements should be considered with any written or oral forward-looking statements that we may issue in the document so incorporated by referencefuture. Except as required by applicable law, including the securities laws of the U.S., we assume no obligation do not intend to update these any of the forward-looking statements publiclyto conform these statements to reflect actual results, later events or circumstances or to update reflect the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the futureoccurrence of unanticipated events. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral Our forward-looking statements attributable to us do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth other investments or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differstrategic transactions we may engage in.
Appears in 1 contract
Samples: At Market Issuance Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus, each prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are information incorporated by reference herein in this prospectus and therein each prospectus supplement contains and may contain certain statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act, Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect . The words “may,” “might,” “can,” “will,” “to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words be,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “estimatepotential,” “maylikely,” “shouldcontinue” and “ongoing,” “anticipate,” “will” and similar statements or the negative of a future these terms, or forward-looking nature other comparable terminology are intended to identify forward-looking statements for purposes of the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” exclusive means of identifying such statements. Those statements appear in this prospectus, any accompanying prospectus supplement and the documents incorporated herein and therein by reference, particularly in the accompanying base prospectus and under the captions sections entitled “The Company,” “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business,” and include statements regarding the intent, belief or current expectations of the Company and management that are subject to known and unknown risks, uncertainties and assumptions. This prospectus, any prospectus supplement and the information incorporated by reference in this prospectus and any prospectus supplement also contain statements that are based on the current expectations of our most recent Annual Report on Form 10-K company and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefullymanagement. Please consider our You are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those projected in light the forward-looking statements as a result of various factors. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely upon forward-looking statements as predictions of future events. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual results could differ materially from those risks as you read this prospectus supplement and projected in the accompanying base prospectusforward-looking statements. It is not possible for our management to predict all The risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may uncertainties and assumptions that could cause actual results to differ materially from those anticipated or implied in our forward-looking statements include, but are not limited to, those set forth above under the section entitled “Risk Factors” and in the applicable prospectus supplement, together with all of the other information contained in or incorporated by reference into the prospectus supplement or appearing or incorporated by reference into this prospectus. Except as required by applicable law, including the securities laws of the United States and the rules and regulations of the SEC, we do not plan to publicly update or revise any forward-looking statements contained herein after we may make. Given these uncertaintiesdistribute this prospectus, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate whether as a result of any date other than the date on the front of this prospectus supplementnew information, future events or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differotherwise.
Appears in 1 contract
Samples: Open Market Sale Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents In this document we file with the SEC that are incorporated by reference herein and therein contain “forwardmake a number of statements, referred to as "FORWARD-looking statements” LOOKING STATEMENTS" within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended 1934 (the “"Exchange Act”"), these statements reflect that are intended to convey our current views with respect to expectations or predictions regarding the occurrence of possible future events or the existence of trends and factors that may impact our ongoing future plans and planned clinical trials, business strategy, business plan, financial performance and other future eventsoperating results. These statements include The safe harbor for forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of provided by the Private Securities Litigation Reform Act of 19951995 does not apply to us. Statements We note, however, that include the words “expect,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or these forward-looking nature statements are derived, in part, from various assumptions and analyses we have made in the context of our current business plan and information currently available to us and in light of our experience and perceptions of historical trends, current conditions and expected future developments and other factors we believe to be appropriate in the circumstances. You can generally identify forward-looking statements for purposes of the federal securities laws or otherwisethrough words and phrases such as "SEEK", "ANTICIPATE", "BELIEVE", "ESTIMATE", "EXPECT", "INTEND", "PLAN", "BUDGET", "PROJECT", "MAY BE", "MAY CONTINUE", "MAY LIKELY RESULT", and similar expressions. All When reading any forward looking statement you should remain mindful that all forward-looking statements involve inherent risks are inherently uncertain as they are based on current expectations and uncertaintiesassumptions concerning future events or future performance of our company, and there are or will be important factors that could cause actual results to differ materially or developments may vary substantially from those indicated expected as expressed in these statements. We believe or implied by that these factors includestatement for a number of reasons or factors, but are including those relating to: o whether or not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible markets for our management to predict all risksproducts develop and, nor can we assess if they do develop, the impact of all factors on our business or the extent to pace at which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differ.they develop;
Appears in 1 contract
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and supplement, the accompanying base prospectus and the documents we file with the SEC that are information incorporated by reference herein and therein contain certain statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the The words “expectbelieve,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “planexpect,” “believecould,” “would,” “project,” “estimateplan,” “maypotentially,” “shouldlikely,” “anticipate,” “will” and similar statements of a future or forward-looking nature expressions and variations thereof are intended to identify forward-looking statements for purposes of the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited tothe exclusive means of identifying such statements. Those statements appear in this prospectus supplement, those factors set forth under the caption accompanying prospectus and the information incorporated by reference herein and therein by reference, particularly in the sections titled “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in and include statements regarding the intent, belief or current expectations of our most recent Annual Report on Form 10-K management that are subject to known and our subsequent Quarterly Reports on Form 10-Q/10-Q/Aunknown risks, all of which you should review carefullyuncertainties and assumptions. Please consider our You are cautioned that any such forward-looking statements in light are not guarantees of those future performance and involve risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risksuncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause and that actual results to may differ materially from those contained projected in any the forward-looking statements we may makeas a result of various factors. Given these Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these rely upon forward-looking statements publicly, as predictions of future events. The events and circumstances reflected in the forward-looking statements may not be achieved or to update the reasons occur and actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available projected in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one Except as required by applicable law, including the securities laws of the United States and the rules and regulations of the SEC, we do not plan to publicly update or more revise any forward-looking statements contained herein after we distribute this prospectus supplement, whether as a result of these any new information, future events or other risks otherwise. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this prospectus supplement, and although we believe such information forms a reasonable basis for such statements, such information may be limited or uncertainties materializesincomplete, and our statements should not be read to indicate that we have conducted a thorough inquiry into, or if review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements. This prospectus supplement, the accompanying prospectus and the information incorporated by reference herein and therein may contain market data that we obtain from industry sources. These sources do not guarantee the accuracy or completeness of the information. Although we believe that our underlying industry sources are reliable, we do not independently verify the information. The market data may include projections that are based on a number of other projections. While we believe these assumptions prove to be incorrectreasonable as of the date of this prospectus supplement, actual results may vary materially differ from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differprojections.
Appears in 1 contract
Samples: At Market Issuance Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are incorporated by reference herein and therein contain “forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include report contains forward-looking statements both with respect to us, specifically, that involve substantial risks and the biotechnology sector, in generaluncertainties. We make In some cases you can identify these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words “expect,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or by forward-looking nature identify words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "should," "will," and "would" or similar words. You should read statements that contain these words carefully because they discuss future expectations, contain projections of future results of operations or of financial position or state other "forward-looking statements for purposes of the federal securities laws or otherwiselooking" information. All forward-looking statements involve inherent risks and uncertainties, and there are or will be The important factors listed above in the section captioned "Risk Factors," as well as any cautionary language in this report, provide examples of risks, uncertainties and events that could may cause the actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated expectations described in these forward-looking statements, even if new information becomes available . You should be aware that the occurrence of the events described in the futurerisk factors and elsewhere in this report could have a material adverse effect on the business, results of operations and financial position of Sonus. ThusAny forward-looking statements in this report are not guarantees of future performances, you should not assume that our silence over time means that and actual events are bearing out as expressed or implied in results, developments and business decisions may differ from those envisaged by such forward-looking statements, possibly materially. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove Sonus disclaims any duty to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral update any forward-looking statements attributable to us or individuals acting on our behalf statements, all of which are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to statements in this prospectus supplement section. ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK. We do not currently use derivative financial instruments. We generally place our marketable security investments in high-quality credit instruments, primarily U.S. Government obligations and corporate obligations with contractual maturities of less than one year. We do not expect any material loss from our marketable security investments and therefore believe that our potential interest rate exposure is not material. To date, sales from our international operations have been made in United States dollars. Accordingly, we have no current material exposure to foreign currency rate fluctuations, though we will continue to evaluate the accompanying base prospectus that could cause actual impact of foreign currency exchange risk on our results to differof operations as we expand internationally.
Appears in 1 contract
Samples: Annual Report
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus, any prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are information incorporated by reference herein in this prospectus and therein any prospectus supplement contain “forward-looking statements” statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (amended, or the “Exchange Act”), that involve substantial risks and uncertainties. Although our forward-looking statements reflect the good faith judgment of our management, these statements reflect can only be based on facts and factors currently known by us. Consequently, these forward-looking statements are inherently subject to risks and uncertainties, and actual results and outcomes may differ materially from results and outcomes discussed in the forward-looking statements. All statements other than present and historical facts and conditions contained in this prospectus, any prospectus supplement and the information incorporated by reference in this prospectus and any prospectus supplement including statements regarding our current views with respect to our ongoing future results of operations and planned clinical trialsfinancial positions, business strategy, business planplans and our objectives for future operations, financial performance and other future events. These statements include are forward-looking statements both with respect to us, specifically, and the biotechnology sector, in generalstatements. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the The words “anticipate,” “believe,” “continue” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “ongoing,” “objective,” “plan,” “believepotential,” “project,” “estimate,” “maypredict,” “should,” “anticipate,” “will” and “would,” or the negative of these and similar statements of a future or forward-looking nature expressions identify forward-looking statements for purposes of the federal securities laws or otherwisestatements. All forwardForward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, statements about: • the success, cost, timing and potential indications of our product candidates’ development activities and clinical trials, including our ongoing and future trials of linzagolix, nolasiban and OBE022; • our ability to obtain and maintain regulatory approval of our product candidates, including linzagolix, nolasiban and OBE022, in any of the indications for which we plan to develop them, and any related restrictions, limitations or warnings in the label of an approved product; • the results of ongoing or future clinical trials, including of linzagolix, nolasiban and OBE022; • our ability to obtain funding for our operations, including funding necessary to complete the clinical trials of any of our product candidates, and the terms on which we are able to raise that additional capital; • our plans to research, develop and commercialize our product candidates; • the timing of our regulatory filings for our product candidates; • the timing of initiating clinical trials for our product candidates; • whether we are aligned with the FDA, or any other regulatory authority, on the development path for our product candidates; • the clinical utility of our product candidates; • the size and growth potential of the markets for our product candidates; • our commercialization, marketing and manufacturing capabilities and strategy; • our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates and our ability to operate our business without infringing on the intellectual property rights of others; • the timing and amount of milestone and royalty payments we are required to make under our license agreements; • our ability to attract and retain qualified employees and key personnel; • our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; • the activities of our competitors and the success of competing therapies that are or become available; • our plans to in-license or acquire additional product candidates; • how long we will qualify as an emerging growth company or a foreign private issuer; • our estimates regarding future revenue, expenses and needs for additional financing; • regulatory developments in the United States and foreign countries; and • other risks and uncertainties, including those factors set forth listed under the caption “Risk Factors” in this prospectus, any prospectus supplement and the information incorporated by reference in the accompanying base this prospectus and under any prospectus supplement. As a result of these factors, we cannot assure you that the captions “Risk Factors,” “Business,” forward-looking statements in this prospectus, any prospectus supplement and “Management’s Discussion the information incorporated by reference in this prospectus and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/Aany prospectus supplement will prove to be accurate. Furthermore, all of which you should review carefully. Please consider if our forward-looking statements in prove to be inaccurate, the inaccuracy may be material. In light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated significant uncertainties in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume regard these statements as a representation or warranty by us or any other person that we will achieve our silence over objectives and plans in any specified time means that actual events are bearing out as expressed frame or implied in such at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. If one or more of these or other risks or uncertainties materializesYou should read this prospectus, or if any prospectus supplement and the information incorporated by reference in this prospectus and any prospectus supplement completely and with the understanding that our underlying assumptions prove to be incorrect, actual future results may vary be materially different from what we anticipateexpect. All subsequent written and oral forward-We qualify all of our forward- looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Notethese cautionary statements. Before purchasing This prospectus, any shares of common stock, you should consider carefully all of prospectus supplement and the factors set forth or referred to information incorporated by reference in this prospectus and any prospectus supplement may contain market data and industry forecasts that were obtained from industry publications. These data involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. While we believe the market position, market opportunity and market size information included in this prospectus, any prospectus supplement and the information incorporated by reference in the accompanying base this prospectus that could cause actual results to differand any prospectus supplement is generally reliable, such information is inherently imprecise.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file with the SEC contains statements that are incorporated by reference herein and therein contain “constitute forward-looking statements” within the meaning . All statements other than statements of Section 27A historical facts contained in this prospectus, including statements regarding our future results of the Securities Actoperations and financial position, and Section 21E of the Securities Exchange Act of 1934business strategy, as amended (the “Exchange Act”)product candidates, these statements reflect our current views with respect to our product pipeline, ongoing and planned clinical trialsstudies, business strategyincluding those of our collaboration partners, business planregulatory approvals, financial performance research and other development costs, timing and likelihood of success, as well as plans and objectives of management for future eventsoperations are forward-looking statements. These statements include Many of the forward-looking statements both with respect to us, specifically, and contained in this prospectus can be identified by the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions use of the Private Securities Litigation Reform Act of 1995. Statements that include the forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or forward-looking nature identify forward“potential,” among others. Forward-looking statements for purposes appear in a number of the federal securities laws or otherwise. All forward-looking statements involve inherent risks places in this prospectus and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those factors set forth expressed or implied in the forward- looking statements due to various factors, including, but not limited to, those identified under the caption section entitled “Risk Factors” in this prospectus supplement prospectus. These risks and uncertainties include factors relating to: · the success of our and our collaboration partners’ clinical studies, and our and their ability to obtain and maintain regulatory approval and to commercialize ACI-35, semorinemab, Morphomer Tau, ACI-24 for Alzheimer’s disease (AD) and for Down syndrome-related AD (ACI-24 for DS), crenezumab, and PI-2620, our Tau-positron emission tomography (PET) imaging tracer and to a lesser extent our preclinical candidates; · the preclinical and clinical safety, efficacy and utility of our product candidates; · the ability of our competitors to discover, develop or commercialize competing products before or more successfully than we do; · our plans to research, develop and commercialize our product candidates; · the identification of serious adverse, undesirable or unacceptable side effects related to our product candidates; · our ability to maintain our current strategic relationships with our collaboration partners; · our ability to protect and maintain our, and not infringe on third parties’, intellectual property rights throughout the world; · our ability to raise capital when needed in order to continue our product development programs or commercialization efforts; · our ability to attract and retain qualified employees and key personnel; · the acceptance by the Food and Drug Administration (FDA) and applicable foreign regulatory authorities of data from studies that we and our collaboration partners conduct within and outside the US now and in the accompanying base prospectus future; · our foreign private issuer status, the loss of which would require us to comply with the Exchange Act’s domestic reporting regime, and under cause us to incur significant legal, accounting and other expenses; · our incorporation in Switzerland, the captions “Risk Factors,” “Business,” laws of which govern our corporate affairs and “Management’s Discussion may differ from those applicable to companies incorporated in the US; and Analysis of Financial Condition and Results of Operations,” · The other risk factors discussed in our most recent Annual Report on Form 1020-K F. We are a clinical stage biopharmaceutical company leveraging our two proprietary technology platforms to discover, design and develop novel, proprietary medicines and diagnostics for prevention and treatment of neurodegenerative diseases associated with protein misfolding. Misfolded proteins are generally recognized as the leading cause of neurodegenerative diseases, such as Alzheimer’s disease, or AD, and Xxxxxxxxx’x disease, or PD, with common mechanisms and drug targets, such as Abeta, Tau, alpha-synuclein and TDP-43. Our corporate strategy is founded upon a three-pillar approach that targets (i) AD, (ii) focused non-Alzheimer’s neurodegenerative diseases including NeuroOrphan indications and (iii) diagnostics. We use our two unique proprietary platform technologies, SupraAntigen (conformation-specific biologics) and Morphomer (conformation-specific small molecules), to discover, design and develop novel medicines and diagnostics to target misfolded proteins. We are a Swiss stock corporation (société anonyme) organized under the laws of Switzerland. We were formed as a Swiss limited liability company (société à responsabilité limitée) on February 13, 2003 with our registered office and domicile in Basel, Switzerland. We converted to a Swiss stock corporation (société anonyme) under the laws of Switzerland on August 25, 2003. Our Swiss enterprise identification number is CHE-109.878.825. Our domicile and registered office is in Ecublens, at the École Polytechnique Fédérale Lausanne (EPFL) Innovation Park Building B, 0000 Xxxxxxxx, Xxxx, Xxxxxxxxxxx. Our common shares were admitted to trading on Nasdaq Global Market on September 23, 2016, and trade under the symbol ACIU. Our registered and principal executive offices are located in Ecublens, at EPFL Innovation Park, Building B, 1015 Lausanne, Switzerland, our general telephone number is (00) 00 000 00 00 and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefullyinternet address is xxx.xxxxxxxx.xxx. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement Our website and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front or accessible through our website are not part of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differprospectus.
Appears in 1 contract
Samples: Open Market Sale Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus financial statements and the other documents we file with the SEC that are incorporated by reference herein and therein in this prospectus supplement contain “forward-looking statements” , including statements concerning our industry, our operations, our anticipated financial performance and financial condition, and our business plans and growth strategy and product development efforts. These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (amended, or the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include Many of the forward-looking statements both with respect to us, specifically, and contained in this prospectus can be identified by the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions use of the Private Securities Litigation Reform Act of 1995. Statements that include the forward-looking words such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “plan,” “believetarget,” “project,” “estimate,” “maybelieve,” “shouldpredict,” “anticipatepotential” or “continue,” “will” and similar statements of a future or among others. Readers are cautioned not to place undue reliance on these forward-looking nature identify statements, which speak only as of their dates. These forward-looking statements for purposes are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain and subject to a number of the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties. The following represent some, and there are or will be important but not necessarily all, of the factors that could cause actual results to differ materially from historical results or those indicated anticipated or predicted by our forward-looking statements: • the timing, progress and results of clinical trials of IFX-1 and any other product candidates, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, the costs of such trials and our research and development programs generally; • the timing and outcome of any discussions or submission of filings for regulatory approval of IFX-1 or any other product candidate, and the timing of and our ability to obtain and maintain regulatory approval of IFX- 1 for any indication; • our ability to leverage our proprietary anti-C5a technology to discover and develop therapies to treat complement-mediated autoimmune and inflammatory diseases; • our ability to protect, maintain and enforce our intellectual property protection for IFX-1 and any other product candidates, and the scope of such protection; • whether the Food and Drug Administration, European Medicines Agency or comparable foreign regulatory authority will accept or agree with the number, design, size, conduct or implementation of our clinical trials, including any proposed primary or secondary endpoints for such trials; • the success of our future clinical trials for IFX-1 and any other product candidates and whether such clinical results will reflect results seen in these statements. We believe that these factors includepreviously conducted preclinical studies and clinical trials; • our expectations regarding the size of the patient populations for, but are not limited tomarket opportunity for and clinical utility of IFX-1 or any other product candidates, those factors set forth if approved for commercial use; • our manufacturing capabilities and strategy, including the scalability and cost of our manufacturing methods and processes and the optimization of our manufacturing methods and processes, and our ability to continue to rely on our existing third-party manufacturers for our planned future clinical trials; • our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing; • our expectations regarding the scope of any approved indication for IFX-1; • our ability to defend against costly and damaging liability claims resulting from the testing of our product candidates in the clinic or, if, approved, any commercial sales; • our ability to commercialize IFX-1 or our other product candidates; • if any of our product candidates obtain regulatory approval, our ability to comply with and satisfy ongoing obligations and continued regulatory overview; • our ability to comply with enacted and future legislation in seeking marketing approval and commercialization; • our future growth and ability to compete, which depends on our retaining key personnel and recruiting additional qualified personnel; • our competitive position and the development of and projections relating to our competitors in the development of C5a inhibitors or our industry; • our expectations regarding the time during which we will be an emerging growth company under the caption JOBS Act or a foreign private issuer; • the recent outbreak of the COVID-19, which may cause business disruptions and could adversely impact our business, including our supply chain, clinical trials and commercialization of our product candidates; and • other risk factors discussed herein under “Risk Factors” in this prospectus supplement and in or incorporated herein by reference. Our actual results or performance could differ materially from those expressed in, or implied by, any forward- looking statements relating to those matters. Accordingly, no assurances can be given that any of the accompanying base prospectus and under events anticipated by the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light will transpire or occur, or if any of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risksthem do so, nor can we assess the what impact of all factors they will have on our business results of operations, cash flows or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by referencefinancial condition. Except as required by law, we assume are under no obligation obligation, and expressly disclaim any obligation, to update these update, alter or otherwise revise any forward-looking statements publiclystatement, whether written or oral, that may be made from time to update the reasons actual results could differ materially from those anticipated in these forward-looking statementstime, even if whether as a result of new information becomes available in the future. Thusinformation, you should not assume that our silence over time means that actual future events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differotherwise.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and supplement, the documents we file with the SEC that are incorporated by reference herein and therein the accompanying prospectus may contain “or incorporate forward-looking statements that are based on our management’s belief and assumptions and on information currently available to our management. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements stated in or implied by these forward-looking statements” within the meaning . All statements other than statements of Section 27A of the Securities Acthistorical facts are forward-looking statements. In some cases, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include you can identify forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words by terminology such as “expectmay,” “intend,” “plan,” “believe,” “project,” “estimate,” “maywill,” “should,” “anticipateexpects,” “willintends,” and similar “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue” or the negative of these terms or other comparable terminology. These statements of a future or forward-looking nature identify are only predictions. You should not place undue reliance on forward-looking statements for purposes of because they involve known and unknown risks, uncertainties and other factors, which are, in some cases, beyond our control and which could materially affect results. You should refer to the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in beginning on page S-6 of this prospectus supplement and in supplement, beginning on page 8 of the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” prospectus, in our most recent Annual Report on Form 1020-F and any updates in each report on From 6-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/Athat indicates that it is being incorporated by reference, all of which you should review carefully. Please consider our forward-looking statements in light of those filed with the SEC for specific risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may that could cause actual results to differ materially be significantly different from those contained stated in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such by these forward-looking statements. If one or more of these or other risks or uncertainties materializesoccur, or if our underlying assumptions prove to be incorrect, actual events or results may vary materially significantly from what we anticipate. All subsequent written and oral those stated in or implied by the forward-looking statements. No forward- looking statement is a guarantee of future performance. Forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all speak only as of the factors set forth date made and we undertake no obligation to publicly update or referred to revise any forward- looking statements, whether as a result of new information, future events or otherwise. You should read this prospectus supplement, the accompanying prospectus and the documents that we reference in this prospectus supplement and have filed with the SEC as exhibits to the registration statement, of which this prospectus supplement is a part, completely and with the understanding that our actual future results may be materially different from any future results stated in or implied by these forward-looking statements. Forward-looking statements in this prospectus supplement include, but are not limited to, statements about: ● the initiation, timing, progress and results of our research and development, manufacturing and commercialization activities with respect to our X-ray source technology or the Nanox.ARC and the Xxxxx.XXXXX, which comprise the Nanox System; ● our ability to successfully demonstrate the feasibility of our technology for commercial applications; ● our expectations regarding the necessity of, timing of filing for, and receipt of, regulatory clearances or approvals regarding our technology, the Nanox.ARC and the Xxxxx.XXXXX; ● our ability to secure and maintain required U.S. Food and Drug Administration (“FDA”) clearance and similar approvals from regulatory agencies worldwide, or Notified Body (“CE”), and comply with applicable quality standards and regulatory requirements; ● our ability to manufacture the Nanox.ARC, at a lower cost than medical imaging systems that use a legacy analog X-ray source; ● the pricing structure of our products and services, if such products and services receive regulatory clearance or approval; ● the implementation of our business models; ● the ability to successfully integrate the business of companies that we acquire and to realize the anticipated benefits of the acquisitions, which may be affected by, among other things, competition, brand recognition, the ability of the acquired company to grow and manage growth profitably and retain its key employees; ● our expectations regarding collaborations with third-parties and their potential benefits; ● our ability to enter into and maintain our arrangements with third-party manufacturers and suppliers; ● our ability to conduct business globally; ● our expectations regarding when certain patents may be issued and the protection and enforcement of our intellectual property rights; ● our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; ● regulatory developments in the United States and other jurisdictions; ● estimates of our expenses, future revenues, capital requirements and our needs for additional financing; ● the rate and degree of market acceptance of our technology and our products; ● development relating to our competitors and the medical imaging industry; ● our estimates of the adoption of the Medical Screening as a Service (“MSaaS”) based model by market participants; ● our estimates regarding the market opportunities for our technology and our products; ● our ability to attract, motivate and retain key executive managers; ● our ability to comply with data protection laws, regulations and similar rules and to establish and maintain adequate cyber-security and data protection; ● our ability to obtain third-party payor coverage or reimbursement of our Nanox System; ● our expectation regarding the maintenance of our foreign private issuer status; ● our expectations regarding changes in the global, national, regional or local economic, business, competitive, market, and regulatory landscape, including as a result of the security, political and economic instability in the Middle East that could harm our business, including due to the current war between Israel and Hamas, and the impact of the COVID-19 pandemic and the ongoing conflict in Ukraine; ● potential litigation associated with our transactions; ● the future trading price of our ordinary shares and impact of securities analysts’ reports on these prices; and ● other risks and uncertainties, including those listed under the caption “Risk Factors” in this prospectus, any accompanying prospectus supplement and our Annual Report on Form 20-F. The “Risk Factors” section of this prospectus supplement, the accompanying prospectus and our most recent Annual Report on Form 20-F reference the principal contingencies and uncertainties to which we believe we are subject, which should be considered in evaluating any forward-looking statements contained or incorporated by reference in this prospectus supplement or in the accompanying base prospectus that could cause actual results to differprospectus.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file have filed with the SEC that are incorporated by reference herein and therein contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (or the “Exchange Act”). These statements relate to future events or to our future operating or financial performance and involve known and unknown risks, these uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. Forward-looking statements may include, but are not limited to, statements about: • our expectations with respect to the clinical development of seladelpar and our other product candidates, our clinical trials and the regulatory approval process; • statements regarding the steps, timing and costs of our development programs; • any projections of earnings, revenue, sufficiency of cash resources or other financial items; • the plans and objectives of management for future operations; • the availability of additional financing and access to capital; • the formation of a trading market for our common stock; • discussions and approvals of regulatory agencies; and • the period of time for which we will be able to fund our operations. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “predict,” “potential” and similar expressions intended to identify forward-looking statements. These statements reflect our current views with respect to our ongoing future events and planned clinical trials, business strategy, business plan, financial performance are based on assumptions and other future events. These statements include forward-looking statements both with respect are subject to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words “expect,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or forward-looking nature identify forward-looking statements for purposes of the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- forward-looking statements. You should not assume that We discuss in greater detail many of these risks under the information heading “Risk Factors” contained in this prospectus supplement is accurate prospectus, and in our most recent annual report on Form 10-K and in our most recent quarterly report on Form10-Q, as of well as any date other than amendments thereto reflected in subsequent filings with the date on the front of this prospectus supplementSEC, or that any information which are incorporated by reference into this prospectus supplement is accurate in their entirety. Also, these forward-looking statements represent our estimates and assumptions only as of any date other than the date of the document so incorporated by referencecontaining the applicable statement. Except as Unless required by law, we assume undertake no obligation to update these or revise any forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if reflect new information becomes available in the futureor future events or developments. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-forward- looking statements. If one or more of these or other risks or uncertainties materializes, or if You should read this prospectus together with the documents we have filed with the SEC that are incorporated by reference and any free writing prospectus that we may authorize for use in connection with this offering completely and with the understanding that our underlying assumptions prove to be incorrect, actual future results may vary be materially different from what we anticipateexpect. All subsequent written and oral We qualify all of the forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differforegoing documents by these cautionary statements.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and supplement, the accompanying base prospectus and prospectus, including the documents we file with the SEC that are incorporated by reference herein and therein contain “forward-looking statements” within the meaning of Section 27A of the Securities Acttherein, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views any free writing prospectus that we have authorized for use in connection with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include this offering contain forward-looking statements both with respect to us, specifically, and within the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions meaning of the Private Securities Litigation Reform Act of 19951995 concerning our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our business operations and financial performance and condition. Statements Any statements contained herein that include the words are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “believepredict,” “projectpotential,” “estimatepositioned,” “mayseek,” “should,” “anticipatetarget,” “will,” “would,” and other similar statements expressions that are predictions or indicate future events and future trends, or the negative of a future these terms or forward-looking nature identify other comparable terminology. These forward-looking statements for purposes of the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth statements about: ∎ our expectations regarding the potential benefits, activity, effectiveness and safety of our product candidates and therapeutics developed utilizing our Probody platform technology; ∎ the initiation, timing, progress and results of our ongoing clinical trials, research and development programs, preclinical studies, and regulatory submissions, including Investigational New Drug (“IND”) applications, Clinical Trial Applications, New Drug Applications (“NDA”) and, Biologics License Applications (“BLA”); ∎ the timing of the completion of our ongoing clinical trials and the timing and availability of clinical data from such clinical trials; ∎ our ability to identify and develop additional product candidates; ∎ our dependence on collaborators for developing, obtaining regulatory approval for and commercializing product candidates in the collaboration; ∎ our or a collaborator’s ability to obtain and maintain regulatory approval of any of our product candidates; ∎ our receipt and timing of any milestone payments or royalties under any research collaboration and license agreements or arrangements; ∎ our expectations and beliefs regarding the caption “Risk Factors” evolution of the market for cancer therapies and development of the immuno-oncology industry; ∎ the rate and degree of market acceptance of any approved product candidates; ∎ the commercialization of any approved product candidates; ∎ our ability to establish and maintain collaborations and retain commercial rights for our product candidates in such collaborations; ∎ the implementation of our business model and strategic plans for our business, technologies and product candidates; ∎ our estimates of our expenses, ongoing losses, future revenue and capital requirements; ∎ our ability to obtain additional funds for our operations; ∎ our or any collaborator’s ability to obtain and maintain intellectual property protection for our technologies and product candidates and our ability to operate our business without infringing, misappropriating or otherwise violating the intellectual property rights of others; ∎ our reliance on third parties to conduct our preclinical studies or any future clinical trials; ∎ our reliance on third-party supply and manufacturing partners to supply the materials and components for, and manufacture, our research and development, preclinical and clinical trial product supplies; ∎ our ability to attract and retain qualified key management and technical personnel; ∎ our ability to secure and maintain licenses of intellectual property to protect our technologies and product candidates; ∎ our financial performance; and ∎ developments relating to our competitors or our industry. You should read this prospectus supplement and in supplement, the accompanying base prospectus prospectus, and under the captions “Risk Factors,” “Business,” documents incorporated by reference herein completely and “Management’s Discussion with the understanding that our actual results may differ materially from what we expect as expressed or implied by our forward-looking statements. In light of the significant risks and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of uncertainties to which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertaintiesare subject, you should not place undue reliance on or regard these forward- statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified timeframe, or at all. We discuss many of these risks in greater detail in the documents incorporated by reference herein, including under the heading “Risk Factors.” These forward-looking statements. You should not assume that the information contained in this prospectus supplement is accurate statements represent our estimates and assumptions only as of any date other than the date on the front dates of this prospectus supplement, or that any information the accompanying prospectus and the documents incorporated by reference into herein and therein, and any free writing prospectus, as applicable, regardless of the time of delivery of this prospectus supplement is accurate as or any sale of any date other than the date of the document so incorporated by reference. Except our common stock and, except as required by law, we assume undertake no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these revise publicly any forward-looking statements, even if whether as a result of new information becomes available in information, future events or otherwise after the futuredate of this prospectus supplement. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such For all forward-looking statements. If one or more , we claim the protection of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral the safe harbor for forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and contained in the accompanying base prospectus that could cause actual results to differPrivate Securities Litigation Reform Act of 1995.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are incorporated by reference herein into this prospectus and therein any prospectus supplement or free writing prospectus may contain “forward-forward- looking statements” within the meaning of Section 27A of the Securities Act, Act and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, only provide our current expectations or forecasts of future events and financial performance and may be identified by the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions use of the Private Securities Litigation Reform Act of 1995. Statements that include the words such terms as “expectbelieves,” “intendestimates,” “plananticipates,” “believeexpects,” “projectplans,” “estimateintends,” “may,” “will” or “should,” “anticipatecould,” “willpredicts” or the negative thereof, or other variations or comparable terminology, though the absence of these words does not necessarily mean that a statement is not forward-looking. Forward-looking statements include all matters that are not historical facts and similar include, without limitation, statements concerning our business strategy, outlook, objectives, future milestones, plans, intentions, goals, and future financial condition, including the period of a future time for which our existing resources will enable us to fund our operations. You should read carefully the risks described in the section entitled “Risk Factors” beginning on page 5 of this prospectus, and in any accompanying prospectus supplement or related free writing prospectus, together with all information incorporated by reference herein and therein, to better understand the significant risks and uncertainties inherent in our business and underlying any forward-looking nature identify statements. Our actual results could differ materially from those contained in the forward-looking statements for purposes of due to the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated described in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption section entitled “Risk Factors” in beginning on page 5 of this prospectus supplement and prospectus; in the accompanying base prospectus and under the captions sections entitled “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our the Company’s most recent Annual Report on Form 10-K K; and our subsequent in the section entitled “Risk Factors” in the Company’s most recent Quarterly Reports Report on Form 10-Q/10Q. These statements include statements about our ability to continue as a going concern; our ability to manufacture BIVIGAM and ASCENIV on a commercial scale and commercialize these products as a result of their approval by the U.S. Food and Drug Administration (the “FDA”) in 2019; our plans to develop, manufacture, market, launch and expand our commercial infrastructure and commercialize our current and future products and the success of such efforts; the safety, efficacy and expected timing of and our ability to obtain and maintain regulatory approvals for our current products and product candidates, and the labeling or nature of any such approvals; the achievement of or expected timing, progress and results of clinical development, clinical trials and potential regulatory approvals for our product candidates; our dependence upon our third-Q/Aparty customers and vendors and their compliance with applicable regulatory requirements; our belief that we have addressed the delays experienced with final drug product Good Manufacturing Practices (“GMP”) release testing by our third-party vendors by adding additional release testing laboratories to our FDA-approved consortium listed in our drug approval documents; our ability to obtain adequate quantities of FDA-approved plasma with proper specifications; our plans to increase our supplies of source plasma, all which include plasma collection center expansion and reliance on third-party supply agreements as well as any extensions to such agreements; the potential indications for our products and product candidates; potential investigational new product applications; the acceptability of any of our products, including BIVIGAM, ASCENIV and Nabi-HB, for any purpose, including FDA-approved indications, by physicians, patients or payers; our plans to evaluate the clinical and regulatory paths to grow the ASCENIV franchise through expanded FDA-approved uses; Federal, state and local regulatory and business review processes and timing by such governmental and regulatory agencies of our business and regulatory submissions; concurrence by the FDA with our conclusions concerning our products and product candidates; the comparability of results of our hyperimmune and immune globulin products to other comparably run hyperimmune and immune globulin clinical trials; the potential for ASCENIV and BIVIGAM to provide meaningful clinical improvement for patients living with Primary Immune Deficiency Disease, Primary Humoral Immunodeficiency Disease or other immune deficiencies or any other condition for which you should review carefullythe products may be prescribed or evaluated; our ability to market and promote Nabi-HB in a highly competitive environment with increasing competition from other antiviral therapies and to generate meaningful revenues from this product; our intellectual property position and the defense thereof, including our expectations regarding the scope of patent protection with respect to ASCENIV or other future pipeline product candidates; our manufacturing capabilities, third-party contractor capabilities and vertical integration strategy; our plans related to the expansion of our manufacturing capacity, yield improvements, supply-chain robustness, in-house fill-finish capabilities, distribution and other collaborative agreements and the success of such endeavors; our estimates regarding revenues, expenses, capital requirements, timing to profitability and the need for and availability of additional financing; possible or likely reimbursement levels for our currently marketed products; estimates regarding market size, projected growth and sales of our existing products as well as our expectations of market acceptance of ASCENIV and BIVIGAM; effects of the coronavirus COVID-19 pandemic on our business, financial condition, liquidity and results of operations, and our ability to continue operations in the same manner as previously conducted prior to the macroeconomic effects of the COVID-19 pandemic; future domestic and global economic conditions or performance; and expectations for future capital requirements. Please consider our There can be no assurance that the forward-looking statements included in light of those risks as you read this document will prove to be accurate. Any forward-looking statements that we make in this prospectus supplement speak only as of the date of such statements and the accompanying base prospectus. It is not possible for our management we undertake no obligation to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in publicly update any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of or to publicly announce revisions to any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if whether as a result of new information becomes available in information, future events or otherwise, except as may otherwise be required by the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differfederal securities laws.
Appears in 1 contract
Samples: Distribution Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement supplement, including the accompanying prospectus, including the documents incorporated by reference herein and therein, and any free writing prospectus that we have authorized for use in connection with this offering contain forward-looking statements concerning our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our business operations and financial performance and condition. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to: any projections of financial information; any statements about historical results that may suggest trends for our business; any statements of the plans, strategies and objectives of management for future operations; any statements of expectation or belief regarding future events, technology developments, our products, product sales, product candidates, partnerships, expenses, liquidity, cash flow, market growth rates or enforceability of our intellectual property rights and related litigation expenses; and any statements of assumptions underlying any of the foregoing. You should read this prospectus supplement, the accompanying prospectus and the documents incorporated by reference herein completely and with the understanding that our actual results may differ materially from what we expect as expressed or implied by our forward-looking statements. In light of the significant risks and uncertainties to which our forward-looking statements are subject, you should not place undue reliance on or regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified timeframe, or at all. We discuss many of these risks in greater detail in the documents incorporated by reference herein, including under the heading “Risk Factors.” These forward-looking statements represent our estimates and assumptions only as of the dates of this prospectus supplement, the accompanying base prospectus and the documents we file with the SEC that are incorporated by reference herein and therein contain “therein, and any free writing prospectus, as applicable, regardless of the time of delivery of this prospectus supplement or any sale of our common stock and, except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements” within , whether as a result of new information, future events or otherwise after the meaning date of Section 27A this prospectus supplement. For all forward-looking statements, we claim the protection of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include safe harbor for forward-looking statements both with respect to us, specifically, and the biotechnology sector, contained in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words “expect,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and similar statements of a future or forward-looking nature identify forward-looking statements for purposes of the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differ.
Appears in 1 contract
Samples: Equity Distribution Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and prospectus, the documents we file with the SEC that are incorporated by reference herein and therein any accompanying prospectus supplement may contain “or incorporate forward-looking statements that relate only to events as of the date on which the statements are made. We undertake no obligation to update any forward-looking statements made in this prospectus to reflect events or circumstances after the date of this prospectus or to reflect new information or the occurrence of unanticipated events, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect you should not place undue reliance on our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future eventsforward-looking statements. These statements include Our forward-looking statements both with respect to usdo not reflect the potential impact of any future acquisitions, specificallymergers, and the biotechnology sectordispositions, in generaljoint ventures or investments. We make these In some cases, you can identify forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words “expect,” “intend,” “plan,” “believe,” “project,” “estimate,” by terminology such as “may,” “shouldwill,” “anticipateexpects,” “willintends,” and similar “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue” or the negative of these terms or other comparable terminology. These statements of a future or forward-looking nature identify are only predictions. You should not place undue reliance on forward-looking statements for purposes of because they involve known and unknown risks, uncertainties and other factors, which are, in some cases, beyond our control and which could materially affect results. You should refer to the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, those factors set forth under the caption “Risk Factors” in section of this prospectus, any accompanying prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 1020-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those F filed with the SEC for specific risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may that could cause actual results to differ materially be significantly different from those contained stated in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such by these forward-looking statements. If one or more of these or other risks or uncertainties materializesoccur, or if our underlying assumptions prove to be incorrect, actual events or results may vary significantly from those stated in or implied by the forward-looking statements. No forward-looking statement is a guarantee of future performance. Forward-looking statements speak only as of the date made and we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You should read this prospectus, any accompanying prospectus supplement and the documents that we reference in this prospectus and have filed with the SEC as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what any future results stated in or implied by these forward-looking statements. Forward-looking statements in this prospectus include, but are not limited to, statements about: ● the initiation, timing, progress and results of our research and development, manufacturing and commercialization activities with respect to our X-ray source technology or the Nanox.ARC and the Xxxxx.XXXXX, which comprise the Nanox System; ● our ability to successfully demonstrate the feasibility of our technology for commercial applications; ● our expectations regarding the necessity of, timing of filing for, and receipt of, regulatory clearances or approvals regarding our technology, the Nanox.ARC and the Xxxxx.XXXXX; ● our ability to secure and maintain required FDA clearance and similar approvals from regulatory agencies worldwide, or Notified Body (“CE”), and comply with applicable quality standards and regulatory requirements; ● our ability to manufacture the Nanox.ARC, at a lower cost than medical imaging systems that use a legacy analog X-ray source; ● the pricing structure of our products and services, if such products and services receive regulatory clearance or approval; ● the implementation of our business models; ● the ability to successfully integrate the business of companies that we anticipate. All subsequent written acquire and oral to realize the anticipated benefits of the acquisitions, which may be affected by, among other things, competition, brand recognition, the ability of the acquired company to grow and manage growth profitably and retain its key employees; ● our expectations regarding collaborations with third-parties and their potential benefits; ● our ability to enter into and maintain our arrangements with third-party manufacturers and suppliers; ● our ability to conduct business globally; ● our expectations regarding when certain patents may be issued and the protection and enforcement of our intellectual property rights; ● our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; ● regulatory developments in the United States and other jurisdictions; ● estimates of our expenses, future revenues, capital requirements and our needs for additional financing; ● the rate and degree of market acceptance of our technology and our products; ● development relating to our competitors and the medical imaging industry; ● our estimates of the adoption of the MSaaS based model by market participants; ● our estimates regarding the market opportunities for our technology and our products; ● our ability to attract, motivate and retain key executive managers; ● our ability to comply with data protection laws, regulations and similar rules and to establish and maintain adequate cyber-security and data protection; ● our ability to obtain third-party payor coverage or reimbursement of our Nanox System; ● our expectation regarding the maintenance of our foreign private issuer status; ● our expectations regarding changes in the global, national, regional or local economic, business, competitive, market, and regulatory landscape, including as a result of the security, political and economic instability in the Middle East that could harm our business, including due to the current war between Israel and Hamas, and the impact of the COVID-19 pandemic and the ongoing conflict in Ukraine; ● potential litigation associated with our transactions; ● the future trading price of our ordinary shares and impact of securities analysts’ reports on these prices; and ● other risks and uncertainties, including those listed under the caption “Risk Factors” in this prospectus, any accompanying prospectus supplement and our Annual Report on Form 20-F. The “Risk Factors” section of this prospectus, any accompanying prospectus supplement and our Annual Report on Form 20-F references the principal contingencies and uncertainties to which we believe we are subject, which should be considered in evaluating any forward-looking statements attributable to us contained or individuals acting on our behalf are expressly qualified in their entirety incorporated by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to reference in this prospectus supplement and or in the any accompanying base prospectus that could cause actual results to differsupplement.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and supplement, the accompanying base prospectus and the other documents we file have filed with the SEC that are incorporated herein by reference herein contain forward- looking statements that involve substantial risks and therein contain “uncertainties. All statements, other than statements of historical facts, regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans, objectives of management or other financial items are forward-looking statements. The words “anticipate,” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “believepredict,” “project,” “estimatewill,” “may,” “should,” “anticipate,” “willwould” and similar statements of a future or forward-looking nature expressions are intended to identify forward-looking statements for purposes of the federal securities laws or otherwise. All statements, although not all forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in contain these statementsidentifying words. We believe that these factors includemay not actually achieve the plans, but are not limited to, those factors set forth under the caption “Risk Factors” intentions or expectations disclosed in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement statements, and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this prospectus supplement, particularly as set forth and incorporated by reference in the “Risk Factors” section above, that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, collaborations or investments we may make. You should not assume read this prospectus supplement, the accompanying prospectus and the documents that the information contained we incorporate by reference in this prospectus supplement completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements, except as otherwise required by law. We advise you, however, to consult any further disclosures we make on related subjects in our future annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K we file with or furnish to the SEC. We may issue and sell shares of our common stock having aggregate sale proceeds of up to $20.0 million from time to time. There can be no assurance that we will be able to sell any shares under or fully utilize the sales agreement with the Agents as a source of financing. Because there is accurate no minimum offering amount required as a condition to close this offering, the actual total public offering amount, commissions and proceeds to us, if any, are not determinable at this time. We currently intend to use any net proceeds from the sale of securities under this prospectus primarily to fund our clinical trials and preclinical programs, for other research and development activities and for general corporate purposes. The amount and timing of our use of the net proceeds from any date other than offerings hereunder will depend on a number of factors, such as the timing and progress of our clinical trial efforts and pre-clinical programs. As of the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should cannot assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully specify with certainty all of the factors set forth or referred particular uses for the net proceeds to in us from this prospectus supplement and offering. Accordingly, our management will have broad discretion in the accompanying base prospectus that could cause actual timing and application of these proceeds. Pending application of the net proceeds as described above, we intend to temporarily invest the proceeds in short-term, interest-bearing instruments. We have never declared or paid any cash dividends on our capital stock, and we do not currently intend to pay any cash dividends on our common stock for the foreseeable future. We expect to retain future earnings, if any, to fund the development and growth of our business. Any future determination to pay dividends on our common stock will be at the discretion of our board of directors and will depend upon, among other factors, our results to differof operations, financial condition, capital requirements and any contractual restrictions.
Appears in 1 contract
Samples: Capital on Demand Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the other documents we file have filed with the SEC that are incorporated herein by reference herein contain forward-looking statements that involve substantial risks and therein contain “uncertainties. All statements, other than statements of historical facts, regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans, objectives of management or other financial items are forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the The words “anticipate,” “believe,” “estimate,” “expect,” “seek,” “intend,” “may,” “plan,” “believepredict,” “project,” “estimatewill,” “may,” “should,” “anticipate,” “willwould” and similar statements of a future or forward-looking nature expressions are intended to identify forward-looking statements for purposes of the federal securities laws or otherwise. All forward-statements, although not all forward- looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in contain these statementsidentifying words. We believe that these factors includemay not actually achieve the plans, but are not limited to, those factors set forth under the caption “Risk Factors” intentions or expectations disclosed in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement statements, and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- our forward-looking statements. You should not assume that Actual results or events could differ materially from the information contained plans, intentions and expectations disclosed in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publiclywe make. We have included important factors in the cautionary statements included in this prospectus, or to update particularly as set forth and incorporated by reference in the reasons “Risk Factors” section below, that we believe could cause actual results could or events to differ materially from those anticipated the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, collaborations, or investments we may make. You should read this prospectus and the documents that we incorporate by reference in these this prospectus completely and with the understanding that our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements, even if new information becomes available except as otherwise required by law. We advise you, however, to consult any further disclosures we make on related subjects in our future annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K we file with or furnish to the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differSEC.
Appears in 1 contract
Samples: Open Market Sale Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file have filed with the SEC that are incorporated by reference herein and therein contain “forward-looking statements” within the meaning of Section 27A of the Securities Act, Act and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical facts contained in this prospectus supplement and the documents we have filed with the SEC that are incorporated by reference, these including statements reflect regarding our current views with respect to our ongoing future results of operations and planned clinical trialsconsolidated financial position, business strategy, business planproduct candidates, financial performance planned preclinical studies and other clinical trials, results of clinical trials, research and development costs, manufacturing costs, regulatory approvals, development and advancement of our oral delivery technology, timing and likelihood of success, as well as plans and objectives of management for future eventsoperations, are forward-looking statements. These statements include involve known and unknown risks, uncertainties, and other important factors that are in some cases beyond our control and may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “plantarget,” “project,” “believe,” “project,” “estimate,” “maypredict,” “shouldpotential,” “anticipateseek,” “willaim,” and or “continue” or the negative of these terms or other similar statements of a future or forward-looking nature identify forwardexpressions. Forward-looking statements for purposes of contained in this prospectus supplement and the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there documents we have filed with the SEC that are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors incorporated by reference include, but are not limited to, statements about: • the progress and focus of our current and future clinical trials in the United States and abroad, and the reporting of data from those factors set forth trials; • our ability to advance product candidates into and successfully complete clinical trials; • the beneficial characteristics, safety, efficacy, and therapeutic effects of our product candidates; • our potential and ability to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; • our ability to complete development of the RaniPill HC or any redesign and conduct additional preclinical and clinical studies of the RaniPill HC or any future design of the RaniPill capsule to accommodate target payloads that are larger than the payload capacity of the RaniPill capsule currently used for our product candidates; • our ability to further develop and expand our platform technology; • our ability to utilize our technology platform to generate and advance additional product candidates; • the accuracy of our estimates regarding expenses, future revenue, capital requirements, and needs for additional financing; • our financial performance; • our plans relating to commercializing our product candidates, if approved; • our ability to selectively enter into strategic partnerships and the expected potential benefits thereof; • the implementation of our strategic plans for our business and product candidates; • our ability to continue to scale and optimize our manufacturing processes by expanding our use of automation; • our estimates of the number of patients in the United States who suffer from the indications we target and the number of patients that will enroll in our clinical trials; • the size of the market opportunity for our product candidates in each of the indications we target; • our ability to continue to innovate and expand our intellectual property by developing novel formulations and new applications of the RaniPill capsule; • our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available; • the scope of protection we are able to establish and maintain for intellectual property rights, including our technology platform and product candidates; • the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; • our expectations regarding the impact of the COVID-19 pandemic and the conflict between Ukraine and Russia on our business; • developments relating to our competitors and our industry, including competing product candidates and therapies; • our realization of any benefit from our organizational structure, taking into account our obligations under the caption Tax Receivable Agreement and the impact of any payments required to be made thereunder on our liquidity and financial condition; • our use of proceeds from the sale of shares of Class A common stock under this prospectus supplement, if any; and • our expectations regarding the period during which we will qualify as an emerging growth company under the Jumpstart Our Business Startups Act of 2012. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions described in the section titled “Risk Factors” and elsewhere in this prospectus supplement. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward- looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, or otherwise. We discuss in greater detail many of these risks under the section titled “Risk Factors” in this prospectus supplement supplement, and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K and in our subsequent most recent Quarterly Reports Report on Form 10-Q/10-Q/A, all of as well as any amendments thereto reflected in subsequent filings with the SEC, which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information are incorporated by reference into this prospectus supplement is accurate in their entirety. Also, these forward-looking statements represent our estimates and assumptions only as of any date other than the date of the document so incorporated by referencecontaining the applicable statement. Except as Unless required by law, we assume undertake no obligation to update these or revise any forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if reflect new information becomes available or future events or developments. You should read this prospectus supplement, accompanying prospectus, together with the documents we have filed with the SEC that are incorporated by reference and any free writing prospectus that we may authorize for use in connection with this offering completely and with the future. Thus, you should not assume understanding that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual future results may vary be materially different from what we anticipateexpect. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully We qualify all of the factors set forth or referred forward- looking statements in the foregoing documents by these cautionary statements. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to in us as of the date of this prospectus supplement supplement, and in the accompanying base prospectus while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that could cause actual results we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to differunduly rely upon these statements.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and prospectus, including the documents that we file with the SEC that are incorporated incorporate by reference herein and therein contain “reference, contains forward-looking statements” statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (amended, or the “Exchange Act”). Any statements about our expectations, these statements reflect our current views with respect to our ongoing beliefs, plans, objectives, assumptions or future events or performance are not historical facts and planned clinical trials, business strategy, business plan, financial performance and other future eventsmay be forward-looking. These statements include forward-looking statements both with respect to usare often, specificallybut are not always, and made through the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions use of the Private Securities Litigation Reform Act of 1995. Statements that include the words or phrases such as “expectmay,” “intendwill,” “plan,” “believe,” “project,” “estimate,” “maycould,” “should,” “anticipateexpects,” “willintends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “continue,” and similar statements expressions, or the negative of a future these terms, or forward-looking nature identify forward-looking statements for purposes of the federal securities laws or otherwisesimilar expressions. All forward-looking Accordingly, these statements involve inherent estimates, assumptions, risks and uncertainties, and there are or will be important factors that uncertainties which could cause actual results to differ materially from those indicated expressed in them. Any forward-looking statements are qualified in their entirety by reference to the factors discussed throughout this prospectus, and in particular those factors referenced in the section “Risk Factors.” This prospectus, including the documents that we incorporate by reference, contain forward-looking statements that are based on our management’s belief and assumptions and on information currently available to our management. These statements relate to future events or our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We believe that these factors Forward-looking statements include, but are not limited to, statements about: • the timing, progress and results of preclinical studies and clinical trials for our current product candidates and other product candidates we may develop, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, and our research and development programs; • the timing, scope or likelihood of regulatory filings and approvals, including timing of Investigational New Drug application and Biological Licensing Application filings for, and final U.S. Food and Drug Administration approval of our current product candidates and any other future product candidates; • the timing, scope or likelihood of foreign regulatory filings and approvals; • our ability to use our understanding of the tumor microenvironment to identify product candidates and to match immunotherapies to select patient subsets; • our ability to develop and advance our current product candidates and programs into, and successfully complete, clinical studies; • our ability to develop combination therapies, whether on our own or in collaboration with third parties; • our manufacturing, commercialization and marketing capabilities and strategy; • the pricing and reimbursement of our current product candidates and other product candidates we may develop, if approved; • the rate and degree of market acceptance and clinical utility of our current product candidates and other product candidates we may develop; • the potential benefits of and our ability to maintain our collaboration with Novartis, and establish or maintain future collaborations or strategic relationships or obtain additional funding; • our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals; • our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering our current product candidates and other product candidates we may develop, the validity of intellectual property rights held by third parties, and our ability not to infringe, misappropriate or otherwise violate any third-party intellectual property rights; • our competitive position, and developments and projections relating to our competitors and our industry; • our expectations related to the use of our existing cash, cash equivalents and marketable securities and the proceeds from our initial public offering and the concurrent private placement; • our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and • the impact of laws and regulations. This prospectus and the documents incorporated by reference also contain estimates, projections and other information concerning our industry, our business, and the markets for certain diseases, including data regarding the estimated size of those factors set forth under markets, and the caption “Risk Factors” incidence and prevalence of certain medical conditions. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources. You should read this prospectus and the documents that we incorporate by reference in this prospectus supplement completely and in with the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in understanding that our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefullyactual future results may be materially different from what we expect. Please consider our The forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectusdocuments we incorporate by reference herein represent our views as of their respective dates. It is not possible for We anticipate that subsequent events and developments will cause our management views to predict all riskschange. However, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements while we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation elect to update these forward-looking statements publiclyat some point in the future, or we have no current intention of doing so except to update the reasons actual results could differ materially from those anticipated in extent required by applicable law. You should, therefore, not rely on these forward-looking statements, even if new information becomes available in statements as representing our views as of any date subsequent to the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more date of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differprospectus.
Appears in 1 contract
Samples: Capital on Demand Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus prospectus, and the documents we file with the SEC that are incorporated by reference herein and therein therein, may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect that are based on management’s beliefs and assumptions and on information currently available to usmanagement. They can be identified by the use of forward-looking words, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that include the words such as “expectanticipate,” “believe,” “could,” “estimate,” “expects,” “intend,” “may,” “plan,” “believepotential,” “predict,” “project,” “estimate,” “may,” “should,” “anticipatewill,” “willwould” and similar statements or the negative of a these terms or other comparable expressions that convey uncertainty of future events or forward-looking nature identify outcomes, although not all forward-looking statements contain these terms. Forward-looking statements may include, but are not limited to, statements regarding our expectations for purposes our clinical development programs that may be ongoing from time to time, the potential approval of any of our product candidates by the federal securities laws FDA or otherwiseany other national entity, the manufacture and commercialization of any product candidate, and any statement that contains forward-looking words and other similar expressions. All The forward-looking statements included in this prospectus supplement and accompanying prospectus, and the documents incorporated by reference herein and therein reflect our current expectations and beliefs, and we do not undertake publicly to update or revise these statements, even if experience or future changes make it clear that any projected results expressed in this prospectus supplement, accompanying prospectus and the documents incorporated by reference herein and therein will not be realized. In addition, the inclusion of any statement in this prospectus supplement, the accompanying prospectus, and the documents incorporated by reference herein and therein does not constitute an admission by us that the events or circumstances described in such statement are material. Furthermore, we wish to caution and advise readers that these statements are based on assumptions that may not materialize and may involve inherent risks and uncertainties, and there many of which are beyond our control that could cause actual events or will be important performance to differ materially from those contained or implied in these forward-looking statements. Among the factors that could cause actual results to differ materially from those indicated in these statements. We believe that these are the factors include, but are not limited to, those factors set forth discussed under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our most recent Annual Report on Form 10-K K, and our subsequent each subsequently filed Quarterly Reports Report on Form 10-Q/10Q, including the following:: · the timing of the initiation, enrollment and completion and results of ongoing or planned clinical trials; · the evolution of scientific discovery around the coronavirus, COVID-19 and the lung and other organ and systems dysfunction resulting in some patients may indicate that CRS or cytokine storm is caused by or results from something other than elevated GM-Q/ACSF levels; · the possibility that FDA might not grant an EUA for lenzilumab in COVID-19 patients or, if one were granted, that its duration might be shorter than anticipated or the EUA might be conditioned to a greater degree than anticipated; · our ability to attain any CMA for lenzilumab in COVID-19 patients in the United Kingdom, European Union or other markets outside the U.S.; · our ability to timely source adequate supply of bulk drug substance and bulk drug product for our development and if approved, commercial products from third-party manufacturers on which we depend; · the negative impact that may result from manufacturing delays due to displacement of scheduled production at certain of our Contract Manufacturing Organizations (“CMOs”) as mandated from Rated Orders issued under the Defense Production Act or the shortage of raw materials and critical components we are experiencing and expect to continue to experience relating to Rated Orders and increased demand for production at our CMOs; · if an EUA or CMA is granted for lenzilumab, our ability to accurately forecast and predict future revenues in the U.S. and outside the U.S. coupled with our ability to produce sufficient quantities on a timely basis to meet demand; · our ability to research, develop and commercialize our product candidates, including our ability to do so before our competitors develop and commercialize competing products or alternative therapies or vaccines that may reduce the demand for our product candidates; · our ability to initiate a study of lenzilumab with commercially available CAR-T therapies in diffuse large B-cell lymphoma; · the ability of partners to initiate and conduct the RATinG and PREACH-M studies of lenzilumab in patients at risk of aGvHD and CMML, respectively, as currently contemplated; · our ability to execute our strategy and business plan focused on developing our proprietary monoclonal antibody portfolio and our GM-CSF knockout gene-editing CAR-T platform; · our ability to enter into partnerships with potential collaborators with development, regulatory and commercialization expertise to enable us to pursue the other initiatives in our development pipeline;our ability to attain the additional financing we may need to pursue our development initiatives, manufacturing requirements and commercialize our product candidates on favorable terms or at all; · the potential, if any, for future development of any of our present or future products; · increasing levels of market acceptance of CAR-T therapies and stem cell transplants and the development of a market for lenzilumab in these therapies; · our ability to identify and develop additional uses for our products; · our ability to maintain licenses with third parties; · our ability to attain market exclusivity and/or to obtain, maintain, protect and enforce our intellectual property and to operate our business without infringing, misappropriating or otherwise violating, the intellectual property rights of others; · the outcome of pending, threatened or future litigation; · acquisitions or in-licensing or out-licensing transactions that we may pursue may fail to perform as expected; · our ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions; · limitations and/or warnings in the label of an approved product candidate, or one that is granted an EUA or CMA, outside the U.S.; · changes in the regulatory landscape that may prevent us from pursuing or realizing any of the expected benefits from the various regulatory incentives, or the imposition of regulations that affect our products; and · the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing. Should one or more known or unknown risks or uncertainties materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated, projected or implied by these forward-looking statements. You should consider these factors and the other cautionary statements made in this prospectus supplement, the accompanying prospectus or the documents we incorporate by reference herein or therein as being applicable to all of which you should review carefully. Please consider our related forward-looking statements wherever they appear in light of those risks as you read this prospectus, any prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent documents incorporated by reference. While we may elect to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any update forward-looking statements wherever they appear in this prospectus supplement, the accompanying prospectus or the documents incorporated by reference, we may makedo not assume, and specifically disclaim, any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law. Given Because of these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one We may issue and sell shares of our common stock having aggregate sales proceeds of up to $62,700,000 from time to time. Because there is no minimum offering amount required pursuant to the sales agreement with Xxxxxx Xxxxxxxxxx, the actual total public offering amount, commissions and proceeds to us, if any, are not determinable at this time. Actual net proceeds will depend on the number of shares we sell and the prices at which such sales occur. There can be no assurance that we will sell any shares under or more fully utilize the sales agreement with Xxxxxx Xxxxxxxxxx as a source of these financing. We intend to use any net proceeds realized from the sales agreement with Xxxxxx Xxxxxxxxxx principally to fund committed and future reservation and other upfront fees to secure manufacturing capacity, to prepare for commercialization of lenzilumab in the event of receipt of an EUA or other risks marketing authorization or uncertainties materializesapproval for use in COVID-19 patients, or as well as for working capital and other general corporate purposes. Our expected use of net proceeds, if our underlying assumptions prove to be incorrectany, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any the sale of shares of common stockstock pursuant to the sales agreement with Xxxxxx Xxxxxxxxxx represents our intentions based upon our present plans and business conditions, you should consider carefully all which could change in the future as our plans and business conditions evolve. The amount and timing of our actual expenditures will depend upon numerous factors, including the results of our research and development efforts, the timing and success of preclinical studies and clinical trials we may commence in the future, the timing of regulatory submissions and the feedback from regulatory authorities. We have not determined the amount of net proceeds to be used specifically for such purposes and, as a result, management will retain broad discretion over the allocation of net proceeds, if any. Pending use of the factors set forth or referred proceeds as described above, we intend to invest the proceeds in this prospectus supplement a variety of capital preservation investments, including short-term, investment-grade, interest-bearing instruments and in the accompanying base prospectus that could cause actual results to differU.S. government securities.
Appears in 1 contract
Samples: Sales Contracts
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus, any prospectus supplement and the accompanying base prospectus supplement, and the documents we file with the SEC that are incorporated by reference herein and therein into this prospectus contain certain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (amended, or the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 19951995 with respect to our business, financial condition, liquidity, and results of operations. Statements that include the These forward-looking statements are not historical facts but rather are plans and predictions based on current expectations, estimates, and projections about our industry, our beliefs, and assumptions. We use words such as “may,” “will,” “could,” “should,” “anticipate,” “expect,” “intend,” “project,” “plan,” “believe,” “projectseek,” “estimate,” “mayassume,” “should,” “anticipate,” “will” and variations of these words and similar statements of a future or forward-looking nature expressions to identify forward-looking statements for purposes of statements. Statements in this prospectus and the federal securities laws or otherwise. All other documents incorporated by reference that are not historical facts are hereby identified as “forward-looking statements” for the purpose of the safe harbor provided by Section 21E of the Exchange Act and Section 27A of the Securities Act. These statements involve inherent risks are not guarantees of future performance and are subject to certain risks, uncertainties, and there other factors, some of which are or will be important factors that beyond our control, are difficult to predict and could cause actual results to differ materially from those indicated expressed or forecasted in these the forward-looking statements. We believe that these factors include, but are not limited to, These risks and uncertainties include those factors set forth under described in the caption section above entitled “Risk Factors,” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, our subsequent Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2020, June 30, 2020, and September 30, 2020, and the risks detailed from time to time on our future reports filed with the SEC. You should not place undue reliance on these forward-looking statements because the matters they describe are subject to certain risks, uncertainties, and assumptions that are difficult to predict. The forward-looking statements contained in this prospectus or any prospectus supplement and are made as of the date of this prospectus or, in the case of any accompanying base prospectus supplement or documents incorporated by reference, the date of any such document. Over time, our actual results, performance, or achievements may differ from those expressed or implied by our forward-looking statements, and such difference might be significant and materially adverse to our security holders. Except as required by law, we undertake no obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise. We have identified some of the important factors that could cause future events to differ from our current expectations and they are described in this prospectus under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” as well as in our most recent Annual Report on Form 10-K and our subsequent any subsequently filed Quarterly Reports on Form 10-Q/10-Q/A, and in other documents that we may file with the SEC, all of which you should review carefully. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differ.
Appears in 1 contract
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are incorporated by reference herein and therein contain “contains forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934about our expectations, as amended (the “Exchange Act”)beliefs or intentions regarding, these statements reflect among other things, our current views with respect to our ongoing and planned clinical trialsproduct development efforts, business strategy, business planbusiness, financial performance and other future eventscondition, results of operations, strategies or prospects. These statements include In addition, from time to time, we or our representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements both with respect to us, specifically, and can be identified by the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions use of the Private Securities Litigation Reform Act of 1995. Statements that include the forward-looking words such as “believe,” “expect,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” or “anticipate,” “will” and similar or their negatives or other variations of these words or other comparable words or by the fact that these statements of a future do not relate strictly to historical or forward-looking nature identify current matters. These forward-looking statements for purposes may be included in, but are not limited to, various filings made by us with the SEC, press releases or oral statements made by or with the approval of one of our authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the federal securities laws or otherwisedate they are made. All Because forward-looking statements involve inherent relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertaintiesuncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, and there including, but not limited to, the factors summarized below. This prospectus identifies important factors which could cause our actual results to differ materially from those indicated by the forward-looking statements, particularly those set forth under the heading “Risk Factors.” The risk factors included in this prospectus are or will be not necessarily all of the important factors that could cause actual results to differ materially from those indicated expressed in these any of our forward-looking statements. We believe Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Factors that these factors could cause our actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: ● our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; ● uncertainties of cash flows and inability to meet working capital needs; ● the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; ● our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; ● our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; ● the clinical development, commercialization and market acceptance of our product candidates; ● our ability to establish and maintain strategic partnerships and other corporate collaborations; ● the implementation of our business model and strategic plans for our business and product candidates; ● the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; ● competitive companies, technologies and our industry; ● risks related to any resurgence of the COVID-19 pandemic and the Russian invasion of Ukraine; ● risks related to not satisfying the continued listing requirements of NYSE American; ● statements as to the impact of the political and security situation in Israel on our business; and ● those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” referred to in our most recent Annual Report on Form 1020-K and F (or any updates in our subsequent Quarterly Reports on Form 106-Q/10-Q/A, all of which you should review carefullyK) incorporated by reference herein in “Item 3. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectusKey Information - D. Risk Factors,” “Item 4. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date Information on the front of this prospectus supplementCompany,” and “Item 5. Operating and Financial Review and Prospects,” as well as in our most recent Annual Report on Form 20-F generally, or that any information which is incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipateprospectus. All subsequent written and oral forward-looking statements attributable to us or individuals persons acting on our behalf speak only as of the date of this prospectus and are expressly qualified in their entirety by the cautionary statements included in this Noteprospectus. Before purchasing any shares We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of common stockunanticipated events. In evaluating forward- looking statements, you should consider carefully all of the factors set forth or referred to in this prospectus supplement these risks and in the accompanying base prospectus that could cause actual results to differuncertainties.
Appears in 1 contract
Samples: At the Market Offering Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This All statements in this prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are incorporated by reference herein and therein contain that are not historical facts should be considered “forward-forward looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), these statements reflect our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology sector, in general. We make these statements pursuant to the safe harbor harbor” provisions of the Private Securities Litigation Reform Act of 1995. Statements Such statements involve known and unknown risks, uncertainties and other factors that include may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Some of the forward-looking statements can be identified by the use of words such as “believe,” “expect,” “may,” “will,” “should,” “seek,” “approximately,” “intend,” “plan,” “believeestimate,” “project,” “estimate,continue” or “may,anticipates” “should,” “anticipate,” “will” or similar expressions or words, or the negatives of those expressions or words. Although we believe that our plans, intentions and similar statements of a future expectations reflected in, or forward-looking nature identify suggested by, such forward-looking statements for purposes are reasonable, we can give no assurance that such plans, intentions, or expectations will be achieved. Some of the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but our expectations are not limited to, those factors set forth disclosed under the caption “Risk Factors” and elsewhere in this prospectus supplement and in the accompanying base prospectus prospectus. All subsequent written and under the captions “Risk Factors,” “Business,” oral forward-looking statements attributable to us, or persons acting on our behalf, are expressly qualified in their entirety by these cautionary statements. Additional risks, uncertainties and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in other factors are incorporated herein by reference to our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, all of which you should review carefully. Please consider as updated by our forward-looking statements in light of those risks as you read this prospectus supplement and subsequent filings under the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by referenceExchange Act. Except as otherwise required by lawapplicable securities laws, we assume undertake no obligation to publicly update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these revise any forward-looking statements, even if whether as a result of new information becomes available in the future. Thusinformation, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializesfuture events, changed circumstances, or if our underlying assumptions prove to be incorrectany other reason, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares after the date of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differsupplement.
Appears in 1 contract
Samples: Credit Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement supplement, the accompanying prospectus, and the accompanying base prospectus and the documents we file with the SEC that are information incorporated by reference herein and therein and any free writing prospectus that we have authorized for use in connection with this offering contain or may include “forward-looking statements” within the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (amended, or the “Exchange Act”), and Section 27A of the Securities Act of 1933, as amended, or the Securities Act. For these purposes, any statements reflect contained or incorporated by reference herein regarding our current views with respect to our ongoing and planned clinical trials, business strategy, business planfuture operations, financial performance position, future revenues, projected costs, prospects, plans and objectives of management, other future eventsthan statements of historical facts, are forward-looking statements. These statements include In some cases, forward-looking statements both with respect to us, specifically, and can be identified by the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions use of the Private Securities Litigation Reform Act of 1995. Statements that include the forward-looking words such as “expectbelieves,” “intend,” “plan,” “believe,” “project,” “estimateexpects,” “may,” “will,” “plans,” “intends,” “estimates,” “could,” “should,” “anticipatewould,” “willcontinue,” “seeks,” “aims,” “projects,” “predicts,” “pro forma,” “anticipates,” “potential” or other similar words (including their use in the negative), or by discussions of future matters such as: the development of product candidates or products, timing and similar success of trial results and regulatory review, potential attributes and benefits of product candidates, the expansion of our drug portfolio, and other statements that are not historical. These statements are based upon the current beliefs and expectations of a future our management but are subject to significant risks and uncertainties, including: • our debt and cash position and the need to raise additional capital in the near future; • the results of our clinical studies, including results in our Phase 2 PEAK Trial of AVTX-002; • drug development costs, timing and other risks, including reliance on investigators and enrollment of patients in clinical trials; • reliance on key personnel; • regulatory risks; • general economic and market risks and uncertainties, including those caused by pandemics and global tensions such as those in Ukraine; • our ability to comply with the applicable continued listing requirements or forward-looking nature identify standards of The Nasdaq Stock Market (“Nasdaq”); and • those other risks detailed in our filings with the SEC. We have based these forward-looking statements for purposes largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of the federal securities laws or otherwiseoperations, business strategy, short-term and long-term business operations and objectives, and financial needs. All These forward-looking statements involve inherent risks are subject to a number of risks, uncertainties and uncertaintiesassumptions, and there are or will be important factors that could cause actual results to differ materially from including those indicated in these statements. We believe that these factors include, but are not limited todescribed above, those factors set forth under the caption described in “Risk Factorscritical accounting estimates” described in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and Part II, Item 7. “Management’s 's Discussion and Analysis of Financial Condition and Results of Operations,Operations – Application of Critical Accounting Estimates” in of our most recent annual report filed on Form 10-K, and those described below under the heading “Risk Factors” and under similar headings in other documents, including in our Annual Report on Form 10-K and for the year ended December 31, 2022, our subsequent Quarterly Reports Report on Form 10-Q/10-Q/AQ for the quarter ended March 31, all of which you should review carefully. Please consider our forward-looking statements 2023 and in light of those risks as you read other filings with the SEC, that are incorporated by reference in this prospectus supplement and the accompanying base prospectus. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given In light of these uncertaintiesrisks, you should not place undue reliance on these forward- looking statements. You should not assume that uncertainties and assumptions, the information contained future events and trends discussed in this prospectus supplement is accurate as of any date other than the date on the front of this and accompanying prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by reference. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons might not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. We undertake no obligation to revise or publicly release the results of any revision to these forward-looking statements, even if new information becomes available in the futureexcept as required by law. ThusGiven these risks and uncertainties, you should readers are cautioned not assume that our silence over time means that actual events are bearing out as expressed or implied in to place undue reliance on such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differcautionary statement.
Appears in 1 contract
Samples: Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and supplement, the accompanying base prospectus and the documents we file have filed with the SEC that are incorporated by reference herein and therein contain “forward-looking statements” statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). In addition, these statements reflect from time to time we or our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include representatives have made or will make forward-looking statements both in various other filings that we make with respect to usthe SEC or in other documents, specificallyincluding press releases or other similar announcements. Forward-looking statements concern our current plans, intentions, beliefs, expectations and the biotechnology sector, in general. We make these statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995future economic performance. Statements that include the words containing terms such as “will,” “may,” “believe,” “do not believe,” “plan,” “expect,” “intend,” “plan,” “believe,” “project,” “estimate,” “may,” “should,” “anticipate,” “will” and other phrases of similar statements of a future or meaning are considered to be forward-looking nature identify forwardstatements. Forward-looking statements for purposes are neither historical facts nor assurances of the federal securities laws or otherwisefuture performance. All forward-looking statements involve inherent Instead, they are based on our current beliefs, expectations and assumptions and are subject to known and unknown risks and uncertainties, and there are or will be important factors uncertainties that could cause actual results to differ materially from those indicated reflected in or implied by these forward-looking statements. We believe Factors that these factors might cause actual results to differ include, but are not limited toamong others, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and under the captions “Risk Factors,” “Business,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” those discussed in our most recent Annual Report on 2023 Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/Aperiodic reports filed with the SEC, all of which you should review carefullyare incorporated by reference herein. Please consider our forward-looking statements in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is Readers are cautioned not possible for our management to predict all risks, nor can we assess the impact of all factors place undue reliance on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward- looking statements. You should not assume that the information contained in this prospectus supplement is accurate as of any date other than the date on the front of this prospectus supplement, the accompanying base prospectus or the documents we have filed with the SEC that any information are incorporated by reference into this prospectus supplement is accurate herein and therein, which reflect management’s views and opinions only as of any date other than the date of the document so incorporated by referencetheir respective dates. Except as required by law, we We assume no obligation to update these forward-looking statements publiclyto reflect actual results, changes in assumptions or to update the reasons actual results could differ materially from those anticipated changes in these other factors affecting such forward-looking statements, even if new information becomes available except to the extent required by applicable securities laws. You are advised, however, to consult any additional disclosures we have made or will make in the future. Thusfilings we make with the SEC, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forwardincluding reports on Forms 10-looking statements. If one or more of these or other risks or uncertainties materializesK, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. 10-Q and 8-K. All subsequent written and oral forward-looking statements attributable to us or individuals persons acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to cautionary statements contained in this prospectus supplement and in supplement, the accompanying base prospectus that could cause actual results to differor any related issuer free writing prospectus.
Appears in 1 contract
Samples: Atm Sales Agreement
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus, each prospectus supplement and the accompanying base prospectus and the documents we file with the SEC that are information incorporated by reference herein in this prospectus and therein each prospectus supplement contain “forward-looking statements” statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended (amended, or the “Exchange Act”), these statements reflect that involve a number of risks and uncertainties. Although our current views with respect to our ongoing and planned clinical trials, business strategy, business plan, financial performance and other future events. These statements include forward-looking statements both with respect reflect the good faith judgment of our management, these statements can only be based on facts and factors currently known by us. Consequently, these forward-looking statements are inherently subject to us, specificallyrisks and uncertainties, and actual results and outcomes may differ materially from results and outcomes discussed in the biotechnology sector, in generalforward-looking statements. We make these Forward-looking statements pursuant to can be identified by the safe harbor provisions use of the Private Securities Litigation Reform Act of 1995. Statements that include the forward-looking words such as “expectbelieves,” “intendexpects,” “hopes,” “may,” “will,” “plan,” “believeintends,” “projectestimates,” “estimate,” “maycould,” “should,” “anticipatewould,” “willcontinue,” “seeks,” “pro forma,” or “anticipates,” or other similar words (including their use in the negative), or by discussions of future matters such as the development of new products, technology enhancements, possible collaborations and similar other statements of a future or forward-looking nature identify forward-looking that are not historical. These statements for purposes of the federal securities laws or otherwise. All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, include but are not limited to, those factors set forth under the caption “Risk Factors” in this prospectus supplement and in the accompanying base prospectus and to statements under the captions “Risk FactorsBusiness,” “Business,Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and in other sections incorporated by reference from our most recent Annual Report on Form 10-K and our subsequent Quarterly Reports on Form 10-Q/10-Q/A, as applicable, as well as our other filings with the SEC. You should be aware that the occurrence of any of the events discussed under the heading “Risk Factors” in any applicable prospectus supplement and any documents incorporated by reference herein or therein could substantially harm our business, operating results and financial condition and that if any of these events occurs, it could adversely affect the value of an investment in our securities. The cautionary statements made in this prospectus are intended to be applicable to all of which you should review carefully. Please consider our related forward-looking statements wherever they may appear in light of those risks as you read this prospectus supplement and the accompanying base prospectus. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may makeprospectus supplement or any documents incorporated by reference herein or therein. Given these uncertainties, We urge you should not to place undue reliance on these forward- forward-looking statements. You should not assume that the information contained in this prospectus supplement is accurate , which speak only as of any date other than the date on the front of this prospectus supplement, or that any information incorporated by reference into this prospectus supplement is accurate as of any date other than the date of the document so incorporated by referencethey are made. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these our forward-looking statements, even if new information becomes available in the future. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. If one or more of these or other risks or uncertainties materializes, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. All subsequent written and oral forward-looking statements attributable to us or individuals acting on our behalf are expressly qualified in their entirety by this Note. Before purchasing any shares of common stock, you should consider carefully all of the factors set forth or referred to in this prospectus supplement and in the accompanying base prospectus that could cause actual results to differ.
Appears in 1 contract
Samples: Sales Agreement