Common use of SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS Clause in Contracts

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus and the applicable prospectus supplement include and incorporate by reference "forward-looking statements." We intend these forward- looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Words such as "anticipate," "estimate," "expect," "project," "intend," "may," "plan," "predict," "believe," "should" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include any statements, other than statements of historical facts, included or incorporated in this prospectus regarding our strategy, future operations, financial position, future revenues, projected costs, prospects, plans and objectives of management. All forward-looking statements reflect the present expectation of future events of our management and are subject to known and unknown risks, uncertainties and assumptions that could cause actual results to differ materially from those described in any forward-looking statements. These risks and uncertainties include, 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 described in greater detail under the heading "Risk Factors" contained in the applicable prospectus supplement and any related free writing prospectus, 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. Given these risks, uncertainties and other important factors, you should not place undue reliance on these forward-looking statements. You should carefully read both this prospectus, the applicable prospectus supplement and any related free writing prospectus, together with the information 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 the date made. We undertake no duty to update these forward-looking statements after the date of this prospectus, except as required by law, even though our situation may change in the future. We qualify all of our forward-looking statements by these cautionary statements.

Appears in 1 contract

Samples: d18rn0p25nwr6d.cloudfront.net

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus and the applicable prospectus supplement include financial statements and incorporate other documents incorporated by reference "in this prospectus contain forward-looking statements." We intend these forward- , 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 to be covered by within the safe harbor provisions for meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Exchange Act. Many of the forward-looking statements contained in this prospectus can be identified by the Private Securities Litigation Reform Act use of 1995. Words such as "anticipate," "estimate," "expect," "project," "intend," "may," "plan," "predict," "believe," "should" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include any statements, other than statements of historical facts, included words such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or incorporated in this prospectus regarding our strategy, future operations, financial position, future revenues, projected costs, prospects, plans and objectives of management. All forward-looking statements reflect the present expectation of future events of our management and are subject to known and unknown risks, uncertainties and assumptions that could cause actual results to differ materially from those described in any forward-looking statements. These risks and uncertainties include, “continue” 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 . Readers are cautioned not 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 described in greater detail under the heading "Risk Factors" contained in the applicable prospectus supplement and any related free writing prospectus, 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. Given these risks, uncertainties and other important factors, you should not place undue reliance on these forward-looking statements. You should carefully read both this prospectus, the applicable prospectus supplement and any related free writing prospectus, together with the information incorporated herein by reference which speak only 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 expecttheir dates. These forward-looking statements represent our are based on estimates and assumptions only as by our management that, although we believe to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties. The following represent some, but not necessarily all, of the date madefactors that could cause actual results to differ from historical results or those 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 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 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 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 under “Risk Factors.” Our actual results or performance could differ materially from those expressed in, or implied by, any forward- looking statements relating to those matters. We undertake Accordingly, no duty to update these assurances can be given that any of the events anticipated by the forward-looking statements after the date will transpire or occur, or if any of this prospectusthem do so, except what impact they will have on our results of operations, cash flows or financial condition. Except as required by law, even though our situation may change in the future. We qualify all of our we are under no obligation, and expressly disclaim any obligation, to update, alter or otherwise revise any forward-looking statements by these cautionary statementsstatement, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise.

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Samples: d18rn0p25nwr6d.cloudfront.net

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement, the accompanying prospectus and the applicable documents that we have filed with the Securities and Exchange Commission, or the SEC, that are incorporated by reference in this prospectus supplement include and incorporate by reference "the accompanying prospectus contain forward- looking statements about us and 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 forward-looking statements." We intend these forward- looking statements to be covered by the safe harbor provisions for . In some cases, you can identify forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Words because they contain words such as "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "project," "intend," "may," "plan," "potential," "predict," "believeproject," "should," and similar "target," "will" or "would" or the negative of these words or expressions are intended to identify forward-looking statementsother similar terms or expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements include include, but are not limited to, statements concerning the following: § the initiation, timing, progress and results of our research and development programs, preclinical studies, any statementsclinical trials and Investigational New Drug, or IND, and other than statements regulatory submissions; § our expectations regarding the activity of historical factsATRC-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, included technologies, and current or incorporated in this prospectus 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 strategyability to expand our pipeline through collaborations, future operationsthe 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, financial position, future revenues, projected costs, prospects, plans Inc.; and objectives § our use of managementthe net proceeds from this offering. All You should not rely on forward-looking statements reflect the present expectation as predictions of future events. We have based the forward-looking statements contained in this prospectus supplement and the accompanying prospectus primarily on our current expectations and projections about future events and trends that we believe may affect our business, financial condition and operating results. The outcome of our management and are the events described in these forward-looking statements is subject to known and unknown risks, uncertainties and assumptions other factors described in 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 cause 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 to results, events or circumstances could differ materially from those described in any forward-looking statements. These risks and uncertainties include, 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 described in greater detail under the heading "Risk Factors" contained in the applicable prospectus supplement and any related free writing prospectus, 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. Given these risks, uncertainties and other important factors, you should not place undue reliance on these forward-looking statements. You should carefully read both this prospectus, the applicable prospectus supplement and any related free writing prospectusthe accompanying prospectus and the documents that we reference in this prospectus supplement and the accompanying prospectus and have filed as exhibits to the registration statement, together of which this prospectus supplement is a part, that we have filed with the information incorporated herein by reference as described under the headings "Incorporation of Certain Documents by Reference" and "Where You Can Find Additional Information," completely and SEC with the understanding that our actual future results results, levels of activity, performance and achievements may be materially different from what we expect. 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 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 unduly rely on these statements. The forward-looking statements represent our estimates and assumptions made in this prospectus supplement relate only to events as of the date on which the statements are made. We undertake no duty obligation to update these any forward-looking statements made in this prospectus supplement to reflect events or circumstances after the date of this prospectusprospectus supplement or to reflect new information or the occurrence of unanticipated events, except as required by law. We may not actually achieve the plans, even though intentions or expectations disclosed in our situation may change in forward-looking statements, and you should not place undue reliance on our forward-looking statements. Our forward-looking statements do not reflect the futurepotential impact of any future acquisitions, mergers, dispositions, joint ventures or investments. We qualify all of our forward-looking statements by these cautionary statements.. USE OF PROCEEDS We currently intend to 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 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 interest-bearing, investment-grade securities. DILUTION 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, 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 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 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 offering $ 6.71 The number of shares of our Class A common stock that 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; § 1,931,353 shares of Class A common stock issuable upon the exercise of stock options issued and outstanding as of June 30, 2020 under our 2019 Equity Incentive Plan, or 2019 Plan, with a weighted average exercise price of $19.85 per share;

Appears in 1 contract

Samples: ir.atreca.com

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus and the applicable prospectus supplement include and incorporate by reference "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. Forward-looking statements are statements other than historical facts and relate to future events or circumstances or our future performance, and they are based on our current assumptions, expectations and beliefs concerning future developments and their potential effect on our business. These forward- looking statements include statements about, among other things, our future financial and operating performance, our future cash flows and liquidity and our growth strategies, as well as anticipated trends in our business and industry. We intend these forward- forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Words such as "anticipate," "” “estimate," "” “expect," "” “project," "” “intend," "” “may," "” “plan," "” “predict," "” “believe," "” “possible,” “should" and similar words or expressions are intended to identify forward-looking statements, statements although not all forward-forward- looking statements contain these identifying words. These forward-looking statements include statements about, among other things: • developments, projections and trends relating to us, our competitors and our industry; • our strategic plans for our business; • our expectations regarding the impact of the COVID-19 pandemic on our business; • our operating performance, including our ability to achieve equal or higher levels of revenue, stabilize the historical fluctuations in our performance and achieve or grow profitability; • the rate and degree of market acceptance and adoption of our genetic and clinical tests and genetic testing and clinical testing generally and other anticipated trends in our industry; • our ability to remain competitive, particularly if the testing markets continue to expand and competition becomes more acute; • our ability to continue to expand the number of genes covered by our tests and introduce other improvements to our tests; • our continued ability to offer affordable pricing for our tests, in spite of recent price degradation in the genetic testing industry, and our ability to maintain the low internal costs of our business model and record acceptable margins on our sales; • our ability to strengthen our existing base of customers by maintaining or increasing demand from these customers; • our ability to grow and diversify our customer base, including our plans to target new institutional and individual customer groups; • our reliance on a limited number of suppliers and ability to adapt to possible disruptions in their operations; • our use of our laboratory facilities and our ability to adapt in the event our facilities are damaged or rendered inoperable; • the level of success of our efforts to increase our global presence, including strengthening relationships with existing and new international customers and establishing other types of arrangements, including our joint venture in the People’s Republic of China, or PRC, or other international joint venture or distributor relationships we may pursue; • the impact on our business of our recent investments in building and restructuring our sales and marketing strategies and teams, in our recently approved tests for COVID-19 and our plans for future sales and marketing efforts; • advancements in technology by us and our competitors; • our use of technology and ability to prevent security breaches, loss of data and other disruptions; • our ability to effectively manage any statementsgrowth we may experience, other than statements including expanding our infrastructure, developing increased efficiencies in our operations and hiring additional skilled personnel in order to support any such growth; • developments with respect to U.S. and foreign regulations applicable to our business, and our ability to comply with these regulations; • our ability to prevent errors in interpreting the results of historical factsour tests so as to avoid product liability and professional liability claims; • our ability to obtain and maintain coverage and adequate reimbursement for our tests and to manage the complexity of billing and collecting such reimbursement; • the state of the U.S. and foreign healthcare markets, included including the role of governments in the healthcare industry generally and pressures or incorporated incentives to reduce healthcare costs while expanding individual benefits, as well as the impact of general uncertainty in this prospectus the U.S. healthcare regulatory environment; • our ability to attract, retain and motivate key scientific and management personnel; • our expectations regarding our strategy, ability to obtain and maintain protection of our trade secrets and other intellectual property rights and not infringe the rights of others; • our expectations regarding our future operations, financial position, expense levels and our ability to appropriately forecast and plan our expenses; • our expectations regarding our future revenues, projected costs, prospects, plans capital requirements and objectives our ability to obtain additional capital if and when needed; and • the impact of managementthe above factors and other future events on the market price of our common stock. All forward-looking statements reflect the management’s present expectation of assumptions, expectations and beliefs regarding future events of our management and are subject to known and unknown risks, uncertainties and assumptions other factors that could cause actual results to differ materially from those described expressed in or implied by any forward-looking statements. These risks and uncertainties include, 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 include those described in greater detail under the heading "Risk Factors" 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 into this prospectus, including our most recent annual report on Form 10-K and in our most recent quarterly report reports on Form 10-Q, as well as any amendments thereto reflected in subsequent filings with the SEC. In light of these risks and uncertainties, these forward-looking events and circumstances may not occur, and actual results could differ materially and adversely from those described in or implied by any forward-looking statements we make. Although we have based our forward-looking statements on assumptions and expectations we believe are reasonable, we cannot guarantee future results, levels of activity, performance or achievements or other future events. Moreover, we operate in a competitive and rapidly evolving industry and new risks emerge from time to time. It is not possible for us to predict all of the risks we may face, nor can we assess the impact of all factors on our business or the extent to which any factor or combination of factors could cause actual results to differ from our expectations. As a result, forward- looking statements should not be relied on or viewed as predictions of future events, and such forward-looking statements should be read with the understanding that actual future results, levels of activity, performance and achievements may be materially different than our current expectations. Given these risks, uncertainties and other important factors, you should not place undue reliance on these forward-looking statements. You should carefully read both this prospectus, the applicable prospectus supplement and any related free writing prospectus, together with the information incorporated herein and therein by reference as described under the headings "Incorporation of Certain Documents by Reference" and "heading “Where You Can Find Additional More 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 the date made. Any such forward-looking statements are not guarantees of future performance and actual results, developments and business decisions may differ from those contemplated by such forward-looking statements. We undertake no duty to update these forward-looking statements after the date of this prospectus, except as required by law, even though our situation may change in the future. You should carefully consider other information set forth in reports or other documents that we file with the SEC. We qualify all of our forward-looking statements by these cautionary statements.

Appears in 1 contract

Samples: Prospectus Supplement

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus contains forward-looking statements within the meaning of the federal securities laws, which statements involve substantial risks and the applicable prospectus supplement include uncertainties. Forward-looking statements generally relate to future events or our future financial or operating performance and incorporate by reference "expectations. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements." We intend these forward- . In some cases, you can identify forward-looking statements to be covered by because they contain words such as “may”, “will”, “should”, “expects”, “plans”, “anticipates”, “could”, “intends”, “target”, “projects”, “contemplates”, “believes”, “estimates”, “predicts”, “potential” or “continue” or the safe harbor provisions for forwardnegative of these words or other similar terms or expressions that concern our expectations, strategy, plans or intentions. Forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Words such as "anticipate," "estimate," "expect," "project," "intend," "may," "plan," "predict," "believe," "should" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include any statements, other than statements of historical facts, included or incorporated in this prospectus regarding include, but are not limited to, statements about: ● our strategy, future financial and results of operations, financial position; ● our growth plans; ● our business plan and our ability to effectively manage our growth; ● our ability to attract and retain brands and advertising agencies; ● the effects of increased competition in our market and our ability to compete effectively; ● our plans to use the proceeds from this offering; ● estimates of our expenses, future revenues, projected costscapital requirements, prospects, plans and objectives of management. All forward-looking statements reflect the present expectation of future events of our management and are subject to known and unknown risks, uncertainties and assumptions that could cause actual results to differ materially from those described in any forward-looking statements. These risks and uncertainties include, among others, changes in and uncertainty of customer acceptance of and demand needs 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 necessaryadditional capital; 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 personnelqualified directors, employees and key personnel such as our founders while maintaining our corporate culture; ● future acquisitions of or investments in complementary companies; and ● the effects of trends on, and fluctuations in, our reliance results of operations. We have based the forward-looking statements contained in this prospectus primarily on suppliers our current expectations and projections about future events and trends that we believe may affect our business, financial condition, results of critical components operations, prospects, business strategy and vendors financial needs. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties, assumptions and other factors described in the supply chain; fluctuations section captioned “Risk Factors” and elsewhere in the market price of critical components; evolving industry standards; the political and regulatory environment in the PRC; and general economic and market conditionsthis prospectus. These risks are not exhaustive. Other sections of this prospectus include additional factors that could adversely impact our business and financial performance. Furthermore, new risks and uncertainties are 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 greater detail under the heading "Risk Factors" contained in the applicable prospectus supplement and any related free writing prospectus, 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. Given these risks, uncertainties and other important factors, you should not place undue reliance on these forward-looking statements. You should carefully read both 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, the applicable prospectus supplement and any related free writing prospectuswhile we believe such information forms a reasonable basis for such statements, together with the such information 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 limited or incomplete, and our statements should not be read to indicate that we expecthave conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements. The forward-looking statements represent our estimates and assumptions made in this prospectus relate only to events as of the date on which such statements are made. We undertake no duty obligation to update these any forward-looking statements after the date of this prospectusprospectus or to conform such statements to actual results or revised expectations, except as required by law. EXHIBIT C NON-UNITED STATES RESIDENTS ONLY INVESTOR REPRESENTATIONS AND WARRANTIES As a condition to Investor’s Subscription, even though our situation the Investor represents, warrants, acknowledges and agrees that the following are true as of the date written below, as of the date of Closing and which representations, warranties, and covenants shall survive the Closing, and acknowledges that the Company is relying thereon, that: C-2.1. Investor is not a U.S. person, as defined in Rule 902 of Regulation S, and is not acquiring the Tokens for the account or benefit of any U.S. person. C-2.2. Investor acknowledges the Company may change offer the Tokens under this Rolling SAFE only to persons outside the United States and either (1) at the time any buy order is originated, the buyer must be outside the United States, or the seller and any person acting on its behalf reasonably believe that the buyer is outside the United States; or (2) the transaction is executed in, on or through a physical trading floor of an established foreign securities exchange that is located outside the United States. Accordingly, Investor was located outside of the United States when receiving and executing this Rolling SAFE, and Investor has not received an offer to purchase the Tokens inside the United States and will not originate a buy order for the Tokens inside the United States. C-2.3. Investor has not received, and is not aware of, any advertisement in a publication with a general circulation in the futureUnited States (as defined in Rule 902 of Regulation S) that refers to the Tokens or the offer or sale of the Tokens. We qualify all Investor acknowledges that it is not acquiring the Tokens as a result of, any "directed selling efforts" (as defined in Rule 902 of our forward-looking statements by these cautionary statements.Regulation S) in the United States in respect of any of the Tokens. C-2.4. Investor understands that the Tokens are being offered and sold in reliance on the safe harbor of Regulation S under the Securities Act and any applicable state securities laws, and that the Company is relying, in part, on the truth and accuracy of, and Investor’s compliance with, the representations, warranties, and covenants set forth herein to determine the availability of the safe harbor to the Company and the eligibility of Investor to acquire the Tokens. C-2.5. Investor agrees that:

Appears in 1 contract

Samples: Continuous Agreement

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus and the applicable prospectus supplement include and incorporate documents we have filed with the SEC that are incorporated by 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, or the Exchange Act. These statements relate to future events or to our future operating or financial performance and involve known and unknown risks, 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." We intend these forward- . Forward-looking statements may include, but are not limited to, statements about: • the size and growth potential of the markets for our products, and our ability to be covered by serve those markets; • the safe harbor provisions impact of the COVID-19 pandemic on our business and operations; • the rate and degree of market acceptance of our products; • ability to expand our sales organization to address effectively existing and new markets that we intend to target; • impact from future regulatory, judicial, and legislative changes or developments in the U.S. and foreign countries; • ability to compete effectively in a competitive industry; • the success of competing technologies that are or may become available; • the performance of our third-party contract sales organizations, suppliers and manufacturers; • our ability to attract and retain key scientific or management personnel; • the accuracy of our estimates regarding expenses, future revenues, reimbursement rates, capital requirements and needs for additional financing; • our ability to comply with the covenants and satisfy certain conditions of our debt facility; • our ability to obtain funding for our operations; and • our ability to attract collaborators and strategic partnerships. In some cases, you can identify forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Words by terms such as "anticipate," "estimate," "expect," "project," "intend," "may," "plan” “will," "predict” “should," "believe” “could," "should" ” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “potential” and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include any statements, other than statements of historical facts, included or incorporated in this prospectus regarding our strategy, future operations, financial position, future revenues, projected costs, prospects, plans and objectives of management. All forward-looking statements reflect the present expectation of our current views with respect to future events of our management and are based on assumptions and are subject to known risks and unknown risksuncertainties. Given these uncertainties, uncertainties and assumptions that could cause actual results to differ materially from those described in any you should not place undue reliance on these forward-looking statements. These risks and uncertainties include, 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 described We discuss in greater detail many of these risks under the heading "Risk Factors" contained in the applicable prospectus supplement and supplement, in any related free writing prospectusprospectuses 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 in their entirety. Given Also, these risksforward-looking statements represent our estimates and assumptions only as of the date of the document containing the applicable statement. Unless required by law, uncertainties and other important factorswe undertake no obligation to update or revise any forward-looking statements to reflect new information or future events or developments. Thus, you should not place undue reliance on these forward-assume that our silence over time means that actual events are bearing out as expressed or implied in such forward- looking statements. You should carefully read both this prospectus, the any applicable prospectus supplement and any related free writing prospectussupplement, together with the information documents we have filed with the SEC that are incorporated herein by reference as described under the headings "Incorporation of Certain Documents by Reference" and "Where You Can Find Additional Information," any free writing prospectus that we may authorize for use in connection with this offering completely and with the understanding that our actual future results may be materially different from what we expect. These We qualify all of the forward-looking statements represent our estimates and assumptions only as of the date made. We undertake no duty to update these forward-looking statements after the date of this prospectus, except as required by law, even though our situation may change in the future. We qualify all of our forward-looking statements foregoing documents by these cautionary statements. PROSPECTUS SUMMARY The following summary highlights information contained or incorporated by reference elsewhere in this prospectus and does not contain all of the information that you should consider in making your investment decision. Before investing in our common stock, you should carefully read this entire prospectus and any related free writing prospectus, as well as the information under the caption “Risk Factors” herein and any related free writing prospectus, and under similar headings in the other documents that are incorporated by reference into this prospectus. You should also carefully read the information incorporated by reference into this prospectus, including our financial statements, and the exhibits to the registration statement of which this prospectus is a part. Company Overview We are a genome analysis company providing tools and services based on our Saphyr® system to scientists and clinicians conducting genetic research and patient testing. We developed the Saphyr system, a platform for ultra- sensitive and ultra-specific structural variation detection, that enables researchers and clinicians to accelerate the search for new diagnostics and therapeutic targets and to streamline the evaluation of changes in chromosomes, which is known as cytogenetics. Our commercial offering includes the Saphyr system, which is comprised of an instrument, chip consumables, reagents and a suite of data analysis tools, and genome analysis services to provide access to data generated by the Saphyr system for researchers who prefer not to adopt the Saphyr system in their labs. Structural variation refers to large-scale structural differences in the genomic DNA of one individual compared to another. Each structural variation involves the rearrangement or repetition of as few as several hundred to as many as tens of millions of DNA base pairs. Structural variations may be inherited or arise spontaneously, and many structural variations cause genetic disorders and diseases. Until our commercial launch of the Saphyr system in February 2017, and since, we believe no other products existed or exist that could more comprehensively and cost and time-efficiently detect structural variation. Our customers include researchers and clinicians who seek to uncover and understand the biological or clinical impact of genome variation to improve the diagnosis and treatment of patients with better clinical tests and new medicines or to replace existing cytogenetic tests that are expensive, slow and labor-intense, with a modern solution designed to simplify workflow and reduce cost and that has the potential to significantly increase diagnostic yields across the industry. Our customers also include researchers in non-human segments, such as agricultural genomics, seeking to advance their understanding of how structural variation impacts industrial applications of plants and animals. We have established relationships with key opinion leaders in genomics research and clinical applications, including rare diseases and oncology, and our installed base of over 138 systems made up of Saphyr and its predecessor system, includes some of the world’s most prominent clinical, translational research, basic research, academic and government institutions as well as leading pharmaceutical and diagnostic companies. Examples include Children’s Hospital of Philadelphia, Children’s National Health System, Boston Children’s Hospital, PerkinElmer, GeneDx, Mayo Clinic, Columbia University, DuPont Pioneer, Garvan Institute of Medical Research, Genentech, XxXxxxxxx Genome Institute at Washington University, National Institutes of Health, Pennsylvania State University, Radboud University Medical Center and Salk Institute for Biological Studies. Approximately 7,000 research use only, or RUO, high throughput sequencers are currently installed worldwide. These sequencers are developed and sold almost entirely by Illumina and are owned by an estimated 3,000 unique customers. Sequencing is very good at detecting genome differences involving just a few base pairs or single- nucleotide variations, which Saphyr cannot detect, but sequencing, including next-generation sequencing, or NGS, cannot reliably detect the larger structural variations that our Saphyr system can detect. Therefore, Saphyr is being adopted alongside this installed base of sequencers as a complement that is designed to give users the ability to see a much wider scope of genome variation than ever before. The Saphyr system, which is for RUO, is also beginning to be adopted by cytogenetics labs that seek to use it in commercial clinical tests of its patients as a laboratory-developed test, or LDT. We estimate that approximately 2,500 cytogenetics labs exist worldwide. These labs currently rely on existing methods such as karyotyping, fluorescence in situ hybridization, or FISH, and microarrays for clinical tests and research that look at chromosomal structure, location and function in cells. Major guidelines for oncology and genetic disease clinical diagnostics recommend first-line structural variation testing by these existing methods. The organizations issuing these guidelines include, among many others, World Health Organization (WHO), National Comprehensive Cancer Network (NCCN), American College of Medical Genetics (ACMG) and American College of Obstetricians & Gynecologists (ACOG). More than 30 medical institutions are conducting more than 20 human translational research and human clinical studies in 2019 and 2020 to assess Xxxxxx’s ability to detect structural variations and diagnose patients and, in certain studies, to compare those results to those produced via existing cytogenetic methods. We expect the findings from these studies, whether assessed internally or published by the institution, beginning in late 2020 or early 2021. Saphyr and its predecessor system have been cited by researchers and clinicians in hundreds of publications covering structural variations in areas of high unmet medical need and research interest, such as rare and undiagnosed pediatric diseases, muscular diseases, developmental delays and disorders, prostate cancer and leukemia. Importantly, Saphyr can be used alone to provide comprehensive detection of structural variations and enable diagnostic calls without the need for sequencing or cytogenetic technology. Saphyr enables these diagnostic calls with low cost per patient, high speed and industry leading performance. Saphyr’s performance characteristics include up to 99% sensitivity, less than 2% false positive rates and accurate diagnosis with allele fraction, or the percentage of sample exhibiting the variant, as low as between 3-5%. In 2020, we launched a new commercial strategy based on the following three approaches: • Get the Service. Customers can submit samples to Bionano Data Services and receive an appropriately filtered set of structural variant calls. Structural variation data is then presented using the Bionano Access visualization software, and files can be exported in the format of choice. Pricing for this service is $650 per genome for standard samples and $750 per genome for mosaic and cancer samples. • Get the Consumables. For customers who commit to purchase at least 120 genomes every six months, the Bionano Support team will install the Saphyr System on the customer’s premises and provide training on sample preparation, instrument operation and data analysis. Pricing for this service is $550 per genome, with installation and training included at no cost, and the Saphyr instrument made available at no charge for the duration of the customer’s project.

Appears in 1 contract

Samples: ir.bionanogenomics.com

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus contains forward-looking statements within the meaning of the federal securities laws, which statements involve substantial risks and the applicable prospectus supplement include uncertainties. Forward-looking statements generally relate to future events or our future financial or operating performance and incorporate by reference "expectations. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements." We intend these forward- . In some cases, you can identify forward-looking statements to be covered by because they contain words such as “may”, “will”, “should”, “expects”, “plans”, “anticipates”, “could”, “intends”, “target”, “projects”, “contemplates”, “believes”, “estimates”, “predicts”, “potential” or “continue” or the safe harbor provisions for forwardnegative of these words or other similar terms or expressions that concern our expectations, strategy, plans or intentions. Forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Words such as "anticipate," "estimate," "expect," "project," "intend," "may," "plan," "predict," "believe," "should" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include any statements, other than statements of historical facts, included or incorporated in this prospectus regarding include, but are not limited to, statements about: ● our strategy, future financial and results of operations, financial position; ● our growth plans; ● our business plan and our ability to effectively manage our growth; ● our ability to attract and retain brands and advertising agencies; ● the effects of increased competition in our market and our ability to compete effectively; ● our plans to use the proceeds from this offering; ● estimates of our expenses, future revenues, projected costscapital requirements, prospects, plans and objectives of management. All forward-looking statements reflect the present expectation of future events of our management and are subject to known and unknown risks, uncertainties and assumptions that could cause actual results to differ materially from those described in any forward-looking statements. These risks and uncertainties include, among others, changes in and uncertainty of customer acceptance of and demand needs 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 necessaryadditional capital; 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 personnelqualified directors, employees and key personnel such as our founders while maintaining our corporate culture; ● future acquisitions of or investments in complementary companies; and ● the effects of trends on, and fluctuations in, our reliance results of operations. We have based the forward-looking statements contained in this prospectus primarily on suppliers our current expectations and projections about future events and trends that we believe may affect our business, financial condition, results of critical components operations, prospects, business strategy and vendors financial needs. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties, assumptions and other factors described in the supply chain; fluctuations section captioned “Risk Factors” and elsewhere in the market price of critical components; evolving industry standards; the political and regulatory environment in the PRC; and general economic and market conditionsthis prospectus. These risks are not exhaustive. Other sections of this prospectus include additional factors that could adversely impact our business and financial performance. Furthermore, new risks and uncertainties are 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 greater detail under the heading "Risk Factors" contained in the applicable prospectus supplement and any related free writing prospectus, 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. Given these risks, uncertainties and other important factors, you should not place undue reliance on these forward-looking statements. You should carefully read both 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, the applicable prospectus supplement and any related free writing prospectuswhile we believe such information forms a reasonable basis for such statements, together with the such information 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 limited or incomplete, and our statements should not be read to indicate that we expecthave conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements. The forward-looking statements represent our estimates and assumptions made in this prospectus relate only to events as of the date on which such statements are made. We undertake no duty obligation to update these any forward-looking statements after the date of this prospectusprospectus or to conform such statements to actual results or revised expectations, except as required by law. EXHIBIT C UNITED STATES RESIDENTS ONLY INVESTOR REPRESENTATIONS AND WARRANTIES As a condition to Investor’s Subscription, even though our situation may change the Investor represents, warrants, acknowledges and agrees that the following are true as of the date written below, as of the date of Closing and which representations, warranties, and covenants shall survive the Closing, and acknowledges that the Company is relying thereon, that: C-1.01. The Tokens being acquired by the Investor pursuant to this Rolling SAFE are not being registered under the Securities Act of 1933, as amended (the "Securities Act"), and applicable state securities laws in reliance upon exemptions from registration, and the Tokens cannot be sold, transferred or otherwise disposed of by the Investor unless they are subsequently registered under the Securities Act and applicable state securities laws, or an exemption from such registration is available at the time of the desired sale. Therefore, the Investor must bear the economic risk of an investment in such Tokens for an indefinite period. The Investor has no right to require registration under federal or state securities laws of such Tokens, and there is no assurance that any trading market in such Tokens will develop. The Investor will not attempt to assign or otherwise transfer all or any portion of such Tokens except in accordance with federal and state securities laws. C-1.02. The Investor is acquiring such Tokens solely for investment for such Investor's own account and has no agreement, understanding or arrangement to subdivide, sell, assign, transfer or otherwise dispose of all or any part of such Tokens to any other person. No other person has or will have a direct or indirect beneficial interest in the futureTokens, except as disclosed to the Company on an attachment hereto. We qualify all of our forward-looking statements by these cautionary statementsTo the extent any other person has any such beneficial interest, the Company will require such persons to execute a signature page to this Rolling SAFE.

Appears in 1 contract

Samples: Continuous Agreement

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus and the applicable prospectus supplement include and incorporate by reference "forward-looking statements." We intend these forward- looking statements to be covered by the safe harbor provisions for contains forward-looking statements that involve risks and uncertainties. The forward-looking statements are contained principally in the Private Securities Litigation Reform Act “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and Analysis of 1995. Words Financial Condition and Results of Operations” and “Business.” In some cases, you can identify forward-looking statements by terms such as "“may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate," "” “project,” “target,” “design,” “estimate," "expect," "project," "intend," "may," "plan," "” “predict," "believe” “potential," "should" ” “plan” or the negative of these terms, and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include any statements, other than statements of historical facts, included or incorporated in this prospectus regarding our strategy, future operations, financial position, future revenues, projected costs, prospects, plans and objectives of management. All forward-looking statements reflect the present expectation of our current views with respect to future events of our management and are based on assumptions and subject to known and unknown risks, uncertainties and assumptions that could cause actual results to differ materially from those described in any forward-looking statements. These risks and uncertainties include, 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 described in greater detail under the heading "Risk Factors" contained in the applicable prospectus supplement and any related free writing prospectus, 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 SECuncertainties. Given these risks, uncertainties and other important factorsuncertainties, you should not place undue reliance on these forward-looking statements. Forward-looking statements include, but are not limited to, statements about: • the timing of enrollment, commencement and completion of our clinical trials; • the timing and success of preclinical studies and clinical trials conducted by us and our development partners; • the ability to obtain and maintain regulatory approval of our clinical trials and product candidates, and the labeling for any approved products; • the scope, progress, expansion, and costs of developing and commercializing our product candidates; • the size and growth of the potential markets for our product candidates and the ability to serve those markets; • our expectations regarding our expenses and revenue, the sufficiency of our cash resources and needs for additional financing; • the rate and degree of market acceptance of any of our product candidates; • our expectations regarding competition; • our anticipated growth strategies; • our ability to attract or retain key personnel; • our ability to establish and maintain development partnerships; • our expectations regarding federal, state and foreign regulatory requirements; • regulatory developments in the United States and foreign countries; • our ability to obtain and maintain intellectual property protection for our product candidates; • the anticipated trends and challenges in our business and the market in which we operate; and • the use or sufficiency of our cash or cash equivalents. Forward-looking statements involve known and unknown risks, 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. Any forward-looking statement made by us in this prospectus speaks only as of the date on which it is made. Except as required by law, we assume no obligation to update these statements publicly, or to update the reasons actual results could differ materially from those anticipated in these statements, even if new information becomes available in the future. We discuss many of these risks in this prospectus in greater detail under the heading “Risk Factors.” Also, these forward-looking statements represent our estimates and assumptions only as of the date of this prospectus. Unless required by United States federal securities laws, we do not intend to update any of these forward-looking statements to reflect circumstances or events that occur after the statement is made. You should carefully read both this prospectusprospectus and the documents that we reference in this prospectus and have filed as exhibits to the registration statement, the applicable of which this prospectus supplement and any related free writing prospectusis a part, together with the information 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 the date made. We undertake no duty to update these forward-looking statements after the date of this prospectus, except as required by law, even though our situation may change in the future. We qualify all of our forward-looking statements by these cautionary statements. This prospectus includes statistical and other industry and market data that we obtained from industry publications and research, surveys and studies conducted by third parties. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. While we believe these industry publications and third-party research, surveys and studies are reliable, we have not independently verified such data. All written and verbal forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this section. We caution investors not to rely too heavily on the forward-looking statements we make or that are made on our behalf. We undertake no obligation, and specifically decline any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. In addition, you should refer to the section of this prospectus entitled “Risk Factors” as well as the documents we have incorporated by reference for a discussion of other important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the 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.

Appears in 1 contract

Samples: ir.aldeyra.com

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement, the accompanying prospectus and the applicable prospectus supplement include and incorporate documents incorporated by reference "forward-looking statements." We intend these forward- looking statements to be covered by the safe harbor provisions for herein and therein contain forward-looking statements contained in the Private Securities Litigation Reform Act of 1995that involve substantial risks and uncertainties. Words such as "anticipate," "estimate," "expect," "project," "intend," "may," "plan," "predict," "believe," "should" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include any All statements, other than statements of historical facts, included or incorporated 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. All forward-looking statements reflect the present expectation of future events of our management and are subject to known and unknown risks, uncertainties and assumptions that could cause actual results to differ materially from those described in any forward-looking statements. These risks The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” “would” and uncertainties similar expressions are intended to identify forward-looking statements, although not all forward- looking statements contain these identifying words. The forward-looking statements in this prospectus supplement, the accompanying prospectus and the documents incorporated herein by reference include, among othersother things, changes in statements about: • our estimates regarding expenses, future revenue, capital requirements and uncertainty of customer acceptance timing and availability of and demand the need for our existing products and technologies and products and technologies under developmentadditional financing; 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 and maintain regulatory approval of injectable meloxicam and our product candidates, and the labeling under any approval that we may obtain; • the results, timing and outcome of 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 and other regulatory developments in the United States and foreign countries; • our ability to raise future financing when necessaryand 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, or our other licensing and collaboration partners; • our ability to operate under increased leverage and associated lending covenants; • the rapidlyperformance of third-changing nature of technology in our industry; risks associated with intellectual propertyparties upon which we depend, including third-party contract research organizations, or CRO’s, and third-party suppliers and manufacturers; • our ability to obtain patent infringement litigation against us as well as the costs protection and unpredictability of litigation over infringement of defend 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 Boardrights against third parties; 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 maintain our relationships and contracts with our key commercial partners; • our ability to recruit or retain skilled personnelkey scientific, technical, commercial, and management personnel or to retain our executive officers; our reliance on suppliers of critical components ability to comply with stringent U.S. and vendors foreign government regulation in the supply chainmanufacture of pharmaceutical products, including Good Manufacturing Practice, or cGMP, compliance and U.S. Drug Enforcement Agency, or DEA, compliance; fluctuations and • the effects of changes in our effective tax rate due to changes in the market price mix of critical components; evolving industry standards; the political and regulatory environment earnings in countries with differing statutory tax rates, changes in the PRC; valuation of deferred tax assets and general economic liabilities and market conditions. Other risks and uncertainties are described in greater detail under the heading "Risk Factors" contained changes in the applicable prospectus supplement and any related free writing prospectustax laws. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, 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. Given these risks, uncertainties and other important factors, you should not place undue reliance on these our forward-looking statements. You should carefully read both 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, particularly under “Risk Factors,” that we believe could cause actual results or events to differ materially from the applicable 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 supplement, the accompanying prospectus and any related free writing prospectus, together with the information incorporated herein documents that we incorporate by reference as described under the headings "Incorporation of Certain Documents by Reference" herein and "Where You Can Find Additional Information," therein completely and with the understanding that our actual future results may be materially different from what we expect. These We do not assume any obligation to update any forward-looking statements statements. USE OF PROCEEDS 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 estimates intentions based upon our current plans and assumptions only as of the date made. We undertake no duty to update these forward-looking statements after the date of this prospectusbusiness conditions, except as required by law, even though our situation may 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. PRICE RANGE OF OUR COMMON STOCK 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 2017 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 2016 First Quarter $ 9.20 $ 5.59 Second Quarter $ 8.78 $ 5.95 Third Quarter $12.50 $ 7.51 Fourth Quarter $10.17 $ 5.89 2015 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. DIVIDEND POLICY 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. We qualify all Payment of future dividends, if any, on our common stock will be at the discretion of our forward-looking statements by these cautionary statementsboard 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: ir.societalcdmo.com

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus and the applicable prospectus supplement include and incorporate documents incorporated by reference "contain forward-looking statements." We intend . 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 to be covered by the safe harbor provisions for forward-looking statements contained may be found, among other places, in the Private sections titled “Business,” “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, as well as any amendments thereto, filed with the SEC. Any statements in this prospectus, or incorporated herein, 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 Litigation Reform Act and Section 21E of the Securities Exchange Act of 19951934, as amended, or the Exchange Act, these forward-looking statements include statements regarding: • the timing and anticipated completion of the merger with Salarius Pharmaceuticals, LLC; • the expected benefits and growth potential of HOTSHOT; • our ability to obtain funding for our operations if the merger is not completed; • our ability to expand the sales of our consumer product; • the size and growth potential of the markets for our consumer product and our drug product candidates, and our ability to serve those markets; • the rate and degree of market acceptance of our consumer product; • the performance of our third-party suppliers and manufacturers; • the success of competing therapies that are, or become, available; • our plans to resume development of our drug product candidates; • the loss of key scientific or management personnel; • our expectations regarding the period during which we qualify as an emerging growth company under the Jumpstart Our Business Startups Act; • the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and • our expectations regarding our ability to obtain and adequately maintain sufficient intellectual property protection for our consumer product and drug product candidates. Words such as "anticipate," "estimate," "expect," "project," "intend," "may," "plan," "predict," "believe," "should" and similar words or expressions are intended to In some cases, you can identify forward-looking statementsstatements by terminology such as “anticipate,” “believe,” “could,” “estimate,” “expects,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “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 identifying words. These forward-looking statements include any statements, other than statements of historical facts, included or incorporated in this prospectus regarding our strategy, future operations, financial position, future revenues, projected costs, prospects, plans and objectives of management. All forward-looking statements reflect the present expectation of future events of our management and are subject to involve known and unknown risks, uncertainties and assumptions other factors that could may cause our actual results results, levels of activity, performance or achievements to differ be materially different from those described in any the information expressed or implied by these forward-looking statements. These risks and uncertainties include, 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 You should refer to 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 described in greater detail under the heading "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 into this prospectus, for a discussion of important factors that may cause our most recent annual report on Form 10actual results to differ materially from those expressed or implied by our forward-K and in our most recent quarterly report on Form 10-Q, as well as any amendments thereto reflected in subsequent filings with the SEClooking statements. Given these risks, uncertainties and other important factors, many of which are beyond our control, we cannot assure you that the forward-looking statements in this prospectus will prove to be accurate, and you should not place undue reliance on these forward-looking statements. You should carefully read both this prospectusFurthermore, the applicable prospectus supplement and any related free writing prospectus, together with the information 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 if our actual future results may be materially different from what we expect. These forward-looking statements represent our estimates and assumptions only as prove to be inaccurate, the inaccuracy may be material. In light of the date madesignificant 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 Except as required by law, we assume no duty obligation to update these forward-looking statements publicly, or to revise any forward-looking statements to reflect events or developments occurring after the date of this prospectus, except as required by law, even though our situation may change if new information becomes available in the future. We qualify all of our forward-looking statements by these cautionary statements.

Appears in 1 contract

Samples: Prospectus Supplement

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying prospectus and the applicable information incorporated by reference in this prospectus supplement include and incorporate by reference "the accompanying prospectus contain “forward-looking statements." We intend these forward- ,” which include information relating to future events, future financial performance, strategies, expectations, competitive environment and regulation. Words such as “may,” “should,” “could,” “would,” “predicts,” “potential,” “continue,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, as well as statements in future tense, identify forward-looking statements. Forward-looking statements 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 that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to: • our history of recurring losses and negative cash flows from operating activities and the uncertainty regarding the adequacy of our liquidity to pursue or complete our business objectives, and substantial doubt regarding our ability to continue as a going concern; • the results of ongoing and future clinical studies; • our inability to successfully develop or commercialize our product candidates; • market acceptance of existing and new products; • our inability to carry out research, development and commercialization plans; • our inability to complete preclinical testing and clinical trials as anticipated; • changes in our relationship with key collaborators; • our ability to adequately protect and enforce rights to intellectual property; • our need to raise additional capital to meet our business requirements in the future and the difficulties in obtaining financing on commercially reasonable terms, or at all; • intense competition in 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; • our inability to manufacture our PURE EP product on a commercial scale on our own or in collaborations with third parties; • entry of new competitors and products and potential technological obsolescence of our products; • effect of healthcare legislation or reform measures that may substantially change the market for medical care or healthcare coverage in the U.S.; • our failure to obtain regulatory approvals; • adverse market and economic conditions; • our ability to maintain the listing of our common stock on The Nasdaq Capital Market; • our business, results of operations and financial condition may be covered adversely impacted by public health epidemics, including the recent COVID-19 outbreak; • loss of one or more key executives; • difficulties in securing and retaining regulatory approval to market our product and product candidates; and • depth of the trading market in our common stock. You should review carefully the section entitled “Risk Factors” beginning on page S-6 of this prospectus supplement for a discussion of these and other risks that relate to our business and investing in our securities. The forward-looking statements contained or incorporated by reference in this prospectus supplement are expressly qualified in their entirety by this cautionary statement. Except as required by applicable law, we do not undertake any obligation to publicly update any forward-looking statement contained in this prospectus supplement, the accompanying prospectus or the documents incorporated by reference herein to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events. For all forward-looking statements, we claim the protection of the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Words DIVIDEND POLICY We have never paid cash dividends on our common stock and do not anticipate paying any cash dividends in the foreseeable future but intend to retain our capital resources for reinvestment in our business. USE OF PROCEEDS We may issue and sell shares of our common stock having aggregate sales proceeds of up to $45,000,000 from time to time. Because there is 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 Jefferies as a source of financing. We currently intend to use the net proceeds from this offering to support commercialization and for working capital and general corporate purposes, including expansion of PURE EP commercialization plans and anticipated expansion of Merimepodib program. We do not currently have more specific plans or commitments with respect to the net proceeds from this offering and, accordingly, are unable to quantify the allocation of such as "anticipate," "estimate," "expect," "project," "intend," "may," "plan," "predict," "believe," "should" proceeds among the various potential uses. Investors will be relying on the judgment of our management, who will have broad discretion regarding the application of the proceeds of this offering. The amounts and similar words or expressions are intended to identify forward-looking statementstiming of our actual expenditures will depend upon numerous factors, although not all forward-looking statements contain these identifying words. These forward-looking statements include any statements, other than statements including the amount of historical facts, included or incorporated in this prospectus regarding cash generated by our strategy, future operations, financial positionthe amount of competition and other operational factors. We may find it necessary or advisable to use portions of the proceeds from this offering for other purposes. From time to time, future revenues, projected costs, prospects, plans we evaluate these and objectives other factors and we anticipate continuing to make such evaluations to determine if the existing allocation of management. All forward-looking statements reflect the present expectation of future events of our management and are subject to known and unknown risks, uncertainties and assumptions that could cause actual results to differ materially from those described in any forward-looking statements. These risks and uncertainties include, 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 propertyresources, including patent infringement litigation against us as well as the costs and unpredictability proceeds of litigation over infringement of our intellectual property and the possibility of our patents this offering, is being reexamined or reviewed by the U.S. Patent and Trademark Office and Patent Trial and Appeal Board; volatility optimized. Circumstances that may give rise to a change in the pricing use of components of our productsproceeds include: ● a change in development plan or strategy; 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 ● the addition of new products by competitorsor applications; changes in end-user demand for technology solutions● technical delays; ● delays or difficulties with our ability to attract clinical trials; ● negative results from our clinical trials; ● difficulty obtaining U.S. Food 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 PRCDrug Administration approval; and general economic and market conditions. Other risks and uncertainties are described in greater detail under the heading "Risk Factors" contained in the applicable prospectus supplement and any related free writing prospectusavailability of other sources of cash including additional offerings, 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. Given these risks, uncertainties and other important factors, you should not place undue reliance on these forward-looking statements. You should carefully read both this prospectus, the applicable prospectus supplement and any related free writing prospectus, together with the information 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 the date made. We undertake no duty to update these forward-looking statements after the date of this prospectus, except as required by law, even though our situation may change in the future. We qualify all of our forward-looking statements by these cautionary statementsif any.

Appears in 1 contract

Samples: ir.biosig.com

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus and the applicable prospectus supplement include and incorporate by reference "forward-looking statements." We intend these forward- looking statements to be covered by the safe harbor provisions for includes forward-looking statements contained in within the Private meaning of Section 27A of the Securities Litigation Reform Act of 19951933, as amended, which we refer to as the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, which we refer to as the Exchange Act, that relate to future events or to our future operations or financial performance. 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 include statements, other than statements of historical fact, about: ● our plans to further develop our FullMAX system of wireless base stations; ● our plans to further develop remote radios; ● the adoption by our target industries of the new IEEE 802.16s standard for private cellular networks; ● our future development priorities; ● our estimates regarding the size of our 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. Words such as "as, but not limited to, “believe,” “expect,” “anticipate," "” “estimate," "expect” “forecast," "” “intend,” “may,” “plan,” “potential,” “predict,” “project," "intend” “targets," "may” “likely," "plan” “will," "predict” “would," "believe” “could," "” “should" ,” “continue,” “scheduled” and similar words expressions or phrases, or the negative of those expressions or phrases, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-Although we believe that we have a reasonable basis for each forward- looking statements include any statements, other than statements of historical facts, included or incorporated statement contained in this prospectus regarding registration statement, we caution you that these statements are based on our strategy, estimates or projections of the future operations, financial position, future revenues, projected costs, prospects, plans and objectives of management. All forward-looking statements reflect the present expectation of future events of our management and that are subject to known and unknown risks, risks and uncertainties and assumptions other important factors that could may cause our actual results results, level of activity, performance, experience or achievements to differ materially from those described in expressed or implied by any forward-looking statementsstatement. These Actual results, level of activity, performance, experience or achievements may differ materially from those expressed or implied by any forward-looking statement as a result of various important factors, including our critical accounting policies and risks and uncertainties includerelating, 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 to: ● our ability to obtain additional financing when necessaryon reasonable terms, or at all; ● our ability to repay our indebtedness; ● the rapidly-changing nature accuracy of technology in our industryestimates regarding expenses, costs, future revenues, uses of cash and capital requirements; risks associated with intellectual property● any outbreak or worsening of an outbreak of contagious 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 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 patent infringement litigation against us as well as the costs their rate and unpredictability degree 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 Boardmarket acceptance; 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 personnelkey scientific or management personnel and to expand our management team; our reliance ability to establish licensing, collaboration or similar arrangements on suppliers favorable terms and our ability to attract collaborators with development, regulatory and commercialization expertise; ● our ability to manage the growth of critical components our business; ● expenditures not resulting in commercially successful products; ● our outreach to global markets; ● our commercialization, marketing and vendors manufacturing capabilities and strategy; ● our ability to expand, protect and maintain our intellectual property position; ● the success of competing third-party products; ● our ability to fully remediate our identified internal control material weaknesses; ● regulatory developments in the supply chain; fluctuations in the market price of critical components; evolving industry standards; the political United States and regulatory environment in the PRCother countries; and general economic and market conditions. Other risks and uncertainties are described in greater detail under the heading "Risk Factors" contained in the applicable prospectus supplement and any related free writing prospectus● our ability to comply with regulatory requirements relating to our business, and in our most recent annual report the costs of compliance with those requirements, including those on Form 10-K data privacy and in our most recent quarterly report on Form 10-Q, as well as any amendments thereto reflected in subsequent filings with the SEC. Given these risks, uncertainties and other important factors, you should not place undue reliance on these forward-looking statements. You should carefully read both this prospectus, the applicable prospectus supplement and any related free writing prospectus, together with the information 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 the date made. We undertake no duty to update these forward-looking statements after the date of this prospectus, except as required by law, even though our situation may change in the future. We qualify all of our forward-looking statements by these cautionary statementssecurity.

Appears in 1 contract

Samples: ir.ondas.com

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus and the applicable prospectus supplement include and incorporate by reference "forward-looking statements." We intend these forward- forward-looking statements to be covered by the safe harbor provisions for forward-forward looking statements contained in the Private Securities Litigation Reform Act of 1995. Words such as "anticipate," "” “estimate," "” “expect," "” “project," "” “intend," "” “may," "” “plan," "” “predict," "” “believe," "” “possible,” “should" and similar words or expressions are intended to identify forward-forward looking statements, statements although not all forward-forward- looking statements contain these identifying words. These forward-forward looking statements include statements about, among other things: • developments, projections and trends relating to us, our competitors and our industry; • our strategic plans for our business; • our operating performance, including our ability to achieve equal or higher levels of revenue, stabilize the historical fluctuations in our performance and achieve or grow profitability; • the rate and degree of market acceptance and adoption of our tests and genetic testing generally and other anticipated trends in our industry; • our ability to remain competitive, particularly if the genetic testing market continues to expand and competition becomes more acute; • our ability to continue to expand the number of genes covered by our tests and introduce other improvements to our tests; • our continued ability to offer affordable pricing for our tests, in spite of recent price degradation in our industry, and our ability to maintain the low internal costs of our business model and record acceptable margins on our sales; • our ability to strengthen our existing base of hospital and medical institution customers by maintaining or increasing demand from these customers; • our ability to grow and diversify our customer base, including our plans to target new institutional and individual customer groups; • our reliance on a limited number of suppliers and ability to adapt to possible disruptions in their operations; • our use of our sole laboratory facility and ability to adapt in the event it is damaged or rendered inoperable; • the level of success of our efforts to increase our global presence, including strengthening relationships with existing and new international customers and establishing other types of arrangements, including our joint venture in the People’s Republic of China, or PRC, or other international joint venture or distributor relationships we may pursue; • the impact on our business of our recent investments in building and restructuring our sales and marketing strategies and teams, and our plans for future sales and marketing efforts; • advancements in technology by us and our competitors; • our use of technology and ability to prevent security breaches, loss of data and other disruptions; • our ability to effectively manage any statementsgrowth we may experience, other than statements including expanding our infrastructure, developing increased efficiencies in our operations and hiring additional skilled personnel in order to support any such growth; • developments with respect to U.S. and foreign regulations applicable to our business, and our ability to comply with these regulations; • our ability to prevent errors in interpreting the results of historical factsour tests so as to avoid product liability and professional liability claims; • our ability to obtain and maintain coverage and adequate reimbursement for our tests and to manage the complexity of billing and collecting such reimbursement; • the state of the U.S. and foreign healthcare markets, included including the role of governments in the healthcare industry generally and pressures or incorporated incentives to reduce healthcare costs while expanding individual benefits, as well as the impact of general uncertainty in this prospectus the U.S. healthcare regulatory environment following the results of the 2016 U.S. presidential election; • our ability to attract, retain and motivate key scientific and management personnel; • our expectations regarding our strategy, ability to obtain and maintain protection of our trade secrets and other intellectual property rights and not infringe the rights of others; • our expectations regarding our future operations, financial position, expense levels and our ability to appropriately forecast and plan our expenses; • our expectations regarding our future revenues, projected costs, prospects, plans capital requirements and objectives our ability to obtain additional capital if and when needed; and • the impact of managementthe above factors and other future events on the market price of our common stock. All forward-looking statements reflect the management’s present expectation of assumptions, expectations and beliefs regarding future events of our management and are subject to known and unknown risks, uncertainties and assumptions other factors that could cause actual results to differ materially from those described expressed in or implied by any forward-looking statements. These risks and uncertainties include, 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 include those described in greater detail under the heading "Risk Factors" contained in the applicable prospectus supplement and this prospectus, any related free writing prospectus, and in our most recent annual report on Form 10-K and in our most recent quarterly report reports on Form 10-Q, as well as any amendments thereto reflected in subsequent filings with the SEC. Given these risks, uncertainties and other important factors, you should not place undue reliance on these forward-looking statements. You should carefully read both this prospectus, the applicable accompanying base prospectus supplement and any related free writing prospectus, together with the information incorporated herein and therein by reference as described under the headings "Incorporation of Certain Documents by Reference" and "heading “Where You Can Find Additional More 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 the date made. Any such forward looking statements are not guarantees of future performance and actual results, developments and business decisions may differ from those contemplated by such forward looking statements. We undertake no duty to update these forward-looking statements after the date of this prospectus, except as required by law, even though our situation may change in the future. You should carefully consider other information set forth in reports or other documents that we file with the SEC. We qualify all of our forward-looking statements by these cautionary statements.

Appears in 1 contract

Samples: Prospectus Supplement

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus supplement and the accompanying prospectus and the applicable documents incorporated by reference into this prospectus supplement include and incorporate by reference "the accompanying prospectus may contain “forward-looking statements." ” within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. Forward-looking statements are statements other than historical facts and relate to future events or circumstances or our future performance, and they are based on our current assumptions, expectations and beliefs concerning future developments and their potential effect on our business. These forward-looking statements include statements about, among other things, our future financial and operating performance, our future cash flows and liquidity and our growth strategies, as well as anticipated trends in our business and industry. We intend these forward- forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Words such as "anticipate," "” “estimate," "” “expect," "” “project," "” “intend," "” “may," "” “plan," "” “predict," "” “believe," "” “possible,” “should" and similar words or expressions are intended to identify forward-looking statements, statements although not all forward-forward- looking statements contain these identifying words. These forward-looking statements include statements about, among other things: • developments, projections and trends relating to us, our competitors and our industry; • our strategic plans for our business; • our expectations regarding the impact of the COVID-19 pandemic on our business; • our operating performance, including our ability to achieve equal or higher levels of revenue, stabilize the historical fluctuations in our performance and achieve or grow profitability; • the rate and degree of market acceptance and adoption of our genetic and clinical tests and genetic testing and clinical testing generally and other anticipated trends in our industry; • our ability to remain competitive, particularly if the testing markets continue to expand and competition becomes more acute; • our ability to continue to expand the number of genes covered by our tests and introduce other improvements to our tests; • our continued ability to offer affordable pricing for our tests, in spite of recent price degradation in the genetic testing industry, and our ability to maintain the low internal costs of our business model and record acceptable margins on our sales; • our ability to strengthen our existing base of customers by maintaining or increasing demand from these customers; • our ability to grow and diversify our customer base, including our plans to target new institutional and individual customer groups; • our reliance on a limited number of suppliers and ability to adapt to possible disruptions in their operations; • our use of our laboratory facilities and our ability to adapt in the event our facilities are damaged or rendered inoperable; • the level of success of our efforts to increase our global presence, including strengthening relationships with existing and new international customers and establishing other types of arrangements, including our joint venture in the People’s Republic of China, or PRC, or other international joint venture or distributor relationships we may pursue; • the impact on our business of our recent investments in building and restructuring our sales and marketing strategies and teams, in our recently approved tests for COVID-19, and our plans for future sales and marketing efforts; • advancements in technology by us and our competitors; • our use of technology and ability to prevent security breaches, loss of data and other disruptions; • our ability to effectively manage any statementsgrowth we may experience, other than statements including expanding our infrastructure, developing increased efficiencies in our operations and hiring additional skilled personnel in order to support any such growth; • developments with respect to U.S. and foreign regulations applicable to our business, and our ability to comply with these regulations; • our ability to prevent errors in interpreting the results of historical factsour tests so as to avoid product liability and professional liability claims; • our ability to obtain and maintain coverage and adequate reimbursement for our tests and to manage the complexity of billing and collecting such reimbursement; • the state of the U.S. and foreign healthcare markets, included including the role of governments in the healthcare industry generally and pressures or incorporated incentives to reduce healthcare costs while expanding individual benefits, as well as the impact of general uncertainty in this prospectus the U.S. healthcare regulatory environment; • our ability to attract, retain and motivate key scientific and management personnel; • our expectations regarding our strategy, ability to obtain and maintain protection of our trade secrets and other intellectual property rights and not infringe the rights of others; • our expectations regarding our future operations, financial position, expense levels and our ability to appropriately forecast and plan our expenses; • our expectations regarding our future revenues, projected costs, prospects, plans capital requirements and objectives our ability to obtain additional capital if and when needed; and • the impact of managementthe above factors and other future events on the market price of our common stock. All forward-looking statements reflect the management’s present expectation of assumptions, expectations and beliefs regarding future events of our management and are subject to known and unknown risks, uncertainties and assumptions other factors that could cause actual results to differ materially from those described expressed in or implied by any forward-looking statements. These risks and uncertainties include, 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 include those described in greater detail under the heading "Risk Factors" contained in the applicable prospectus supplement and this prospectus, any related free writing prospectus, and in our most recent annual report on Form 10-K and in our most recent quarterly report reports on Form 10-Q, as well as any amendments thereto reflected in subsequent filings with the SEC. In light of these risks and uncertainties, these forward-looking events and circumstances may not occur, and actual results could differ materially and adversely from those described in or implied by any forward-looking statements we make. Although we have based our forward-looking statements on assumptions and expectations we believe are reasonable, we cannot guarantee future results, levels of activity, performance or achievements or other future events. Moreover, we operate in a competitive and rapidly evolving industry and new risks emerge from time to time. It is not possible for us to predict all of the risks we may face, nor can we assess the impact of all factors on our business or the extent to which any factor or combination of factors could cause actual results to differ from our expectations. As a result, forward-looking statements should not be relied on or viewed as predictions of future events, and such forward-looking statements should be read with the understanding that actual future results, levels of activity, performance and achievements may be materially different than our current expectations. Given these risks, uncertainties and other important factors, you should not place undue reliance on these forward-looking statements. You should carefully read both this prospectus, the applicable accompanying base prospectus supplement and any related free writing prospectus, together with the information incorporated herein and therein by reference as described under the headings "Incorporation of Certain Documents by Reference" and "Where You Can Find Additional More Information” and “Incorporation of Certain Information By Reference," 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 the date made. Any such forward-looking statements are not guarantees of future performance and actual results, developments and business decisions may differ from those contemplated by such forward-looking statements. We undertake no duty to update these forward-looking statements after the date of this prospectus, except as required by law, even though our situation may change in the future. You should carefully consider other information set forth in reports or other documents that we file with the SEC. We qualify all of our forward-looking statements by these cautionary statements.

Appears in 1 contract

Samples: Prospectus Supplement

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus and the applicable prospectus supplement include and incorporate documents incorporated by reference "forward-looking statements." We intend these forward- looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Words such as "anticipate," "estimate," "expect," "project," "intend," "may," "plan," "predict," "believe," "should" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include any statements, other than statements of historical facts, included or incorporated in this prospectus regarding our strategy, future operations, financial position, future revenues, projected costs, prospects, plans and objectives of management. All forward-looking statements reflect the present expectation of future events of our management and are subject to known and unknown risks, uncertainties and assumptions that could cause actual results to differ materially from those described in any forward-looking statements. These risks are based on our management’s current beliefs, expectations and uncertainties 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. 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, among othersbut are not limited to, changes in statements about: • the prospects of attaining, maintaining and uncertainty expanding marketing authorization for monalizumab, lacutamab and our other product candidates; • the initiation, timing, progress and results of customer acceptance of our preclinical studies and demand for clinical trials and those conducted by third parties, including our existing products and technologies and products and technologies under developmentcollaborator AstraZeneca; 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 successfully develop and advance our NVvault™ pipeline of product candidates; • the timing or likelihood of regulatory filings and EXPRESSvault™ technology 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 more diverse customer basecommercial-stage company; • the pricing and reimbursement of Lumoxiti and our need to raise additional capital 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 financing when necessaryfunding for our operations; the rapidly-changing nature of technology in our industry; risks associated with intellectual propertyability to obtain, including patent infringement litigation against us as well as the costs maintain, protect and unpredictability of litigation over infringement of enforce our intellectual property rights and propriety technologies and to operate our business without infringing the possibility intellectual property rights and proprietary technology of our patents being reexamined or reviewed by the U.S. Patent and Trademark Office and Patent Trial and Appeal Boardthird parties; volatility • regulatory developments in the pricing United States, Europe and other countries; • costs of components 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 productsbusiness, financial condition and results of operations; changes in and uncertainty of customer acceptance of, • other risks and demand for, our existing products and products under developmentuncertainties, 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 those listed in the supply chain; fluctuations in the market price section 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 described in greater detail under the heading "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 into this prospectus for a discussion of important factors that may cause our most recent annual report on Form 10actual results to differ materially from those expressed or implied by our forward-K and in our most recent quarterly report on Form 10-Q, as well as any amendments thereto reflected in subsequent filings with the SEClooking statements. Given As a result of these risks, uncertainties and other important factors, we cannot assure you should not place undue reliance on that the 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 and Section 21E of the Securities Exchange Act of 1934, as amended, do not protect any forward-looking statements that we make in connection with this prospectus. 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, 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 potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements. You should carefully read both this prospectus, prospectus and the applicable documents that we reference in this prospectus supplement and any related free writing prospectus, together with the information incorporated herein by reference have filed as described under the headings "Incorporation of Certain Documents by Reference" and "Where You Can Find Additional Information," exhibits to this prospectus completely and with the understanding that our actual future results results, levels of activity, performance and events and circumstances may be materially different from what we expect. These forward-looking statements represent our estimates and assumptions only as of the date made. We undertake no duty to update these forward-looking statements after the date of this prospectus, except as required by law, even though our situation may change in the future. We qualify all of our forward-looking statements by these cautionary statements. Unless otherwise indicated, information contained in this prospectus or incorporated by reference concerning our industry and the markets in which we operate, including our general expectations and market position, market opportunity and market size estimates, is 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 such industry and market, which we believe to be reasonable. In addition, while we believe the market opportunity information included in this prospectus or incorporated by reference is generally reliable and 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 section titled “Risk Factors.” of this prospectus.

Appears in 1 contract

Samples: Prospectus Supplement

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