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

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus contains forward-looking statements that involve risks and uncertainties. The forward-looking statements are contained principally in “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and Analysis of 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,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, 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 read this prospectus and the documents that we reference in this prospectus and have filed as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we expect. 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: Sales Agreement

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus contains and the applicable prospectus supplement include and incorporate by reference “forward-looking statements.” We intend these forward-looking statements that involve risks and uncertainties. The forward-to be covered by the safe harbor provisions for forward looking statements are contained principally in the Private Securities Litigation Reform Act of 1995. Words such as Prospectus Summaryanticipate,” “Risk Factorsestimate,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business.” In some cases, you can identify forward-looking statements by terms such as “mayexpect,” “might,” “will,” “objectiveproject,” “intend,” “shouldmay,” “couldplan,” “can,” “would,” “expectpredict,” “believe,” “anticipatepossible,” “project,should“target,” “design,” “estimate,” “predict,” “potential,” “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 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; • 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 our 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, including the role of governments in the healthcare industry generally and pressures or incentives to reduce healthcare costs while expanding individual benefits, as well as the impact of general uncertainty in 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 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 expense levels and our ability to appropriately forecast and plan our expenses; • our expectations regarding our future capital requirements and our ability to obtain additional capital if and when needed; and • the impact of the above factors and other future events on the market price of our common stock. All forward-looking statements reflect management’s present assumptions, expectations and beliefs regarding future events and are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those expressed in or implied by any forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertaintiesuncertainties include those described under the heading “Risk Factors” contained in this prospectus, any related free writing prospectus, and in our most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as any amendments thereto reflected in subsequent filings with the SEC. Given these uncertaintiesrisks, uncertainties and other important factors, 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 revenueYou should carefully read this prospectus, the sufficiency of our cash resources accompanying base prospectus and needs for additional financing; • any related free writing prospectus, together with the rate information incorporated herein 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 therein by the forward-looking statements. Any forward-looking statement made by us in this prospectus speaks only reference 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 described under the heading “Risk Factors.Where You Can Find More Information,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 read this prospectus and the documents that we reference in this prospectus and have filed as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what 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. 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: Equity Distribution Agreement

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus contains supplement and the accompanying prospectus and the information incorporated by reference in this prospectus supplement and the accompanying prospectus contain “forward-looking statements that involve risks and uncertainties. The forward-looking statements are contained principally in “Prospectus Summarystatements,” “Risk Factors,” “Management’s Discussion which include information relating to future events, future financial performance, strategies, expectations, competitive environment and Analysis of Financial Condition and Results of Operations” and “Business.” In some cases, you can identify forward-looking statements by terms regulation. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design,” “estimate,” “predictpredicts,” “potential,” “plancontinue,or the negative of these terms, “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” and similar expressions intended to expressions, as well as statements in future tense, identify forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Forward-looking statements should not be read as a guarantee of future performance or results and may 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, statements about: • our history of recurring losses and negative cash flows from operating activities and the timing of enrollment, commencement and completion uncertainty regarding the adequacy of our clinical trialsliquidity to pursue or complete our business objectives, and substantial doubt regarding our ability to continue as a going concern; • the timing results of ongoing and success of preclinical studies and future clinical trials conducted by us and our development partnersstudies; • the ability our inability 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 successfully develop or commercialize our product candidates; • the size market acceptance of existing and growth of the potential markets for our product candidates and the ability to serve those marketsnew products; • our expectations regarding our expenses inability to carry out research, development and revenue, the sufficiency of our cash resources and needs for additional financingcommercialization plans; • delays in any phase of the rate preclinical or clinical development of a product, including during its research and degree of market acceptance of any of our product candidatesdevelopment; • our expectations regarding competitioninability to complete preclinical testing and clinical trials as anticipated; • changes in our anticipated growth strategiesrelationship with key collaborators; • our ability to attract 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 retain key personnelat 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.; • the ongoing COVID-19 pandemic; • our failure to obtain regulatory approvals; • adverse market and economic conditions; • our ability to establish and maintain development partnershipsthe listing of our common stock on the Nasdaq Capital Market; • our expectations regarding federal, state and foreign regulatory requirementsloss of one or more key executives; • difficulties in securing and retaining regulatory developments in the United States approval to market our product and foreign countries; • our ability to obtain and maintain intellectual property protection for our product candidates; and depth of the anticipated trends trading market in our common stock. You should review carefully the section entitled “Risk Factors” beginning on page S-3 of this prospectus supplement for a discussion of these and challenges in other risks that relate to our business and the market investing in which we operate; and • the use or sufficiency of our cash or cash equivalentssecurities. 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 The forward-looking statements represent our estimates and assumptions only as of the date of this prospectus. Unless required contained or incorporated 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 read this prospectus and the documents that we reference in this prospectus and have filed as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we expect. 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 supplement are expressly qualified in their entirety by the this cautionary statements contained or referred statement. Except as required by applicable law, we do not undertake any obligation to in this section. We caution investors not to rely too heavily on the publicly update any forward-looking statements we make statement contained in this prospectus supplement, the accompanying prospectus or that are the documents incorporated by reference herein to reflect events or circumstances after the date on which any such statement is made on our behalfor to reflect the occurrence of unanticipated events. We undertake no obligation, and specifically decline any obligation, to update or revise publicly any For all forward-looking statements, whether as a result we claim the protection 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 safe harbor 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 contained in this prospectus the Private Securities Litigation Reform Act of 1995. 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. Any future determination to declare dividends will prove be made at the discretion of our board of directors and will depend on our financial condition, operating results, capital requirements, general business conditions and other factors that our board of directors may deem relevant. Our ability to be accurate. Furthermore, if pay dividends is presently restricted pursuant to the terms of 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 allSeries C Preferred Stock.

Appears in 1 contract

Samples: Atm Sales Agreement

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus contains supplement and the accompanying prospectus and the documents incorporated by reference into this prospectus supplement and 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 that involve risks include statements about, among other things, our future financial and uncertaintiesoperating performance, our future cash flows and liquidity and our growth strategies, as well as anticipated trends in our business and industry. The We intend these forward-looking statements are contained principally in “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business.” In some cases, you can identify to be covered by the safe harbor provisions for forward-looking statements by terms contained in the Private Securities Litigation Reform Act of 1995. Words such as “mayanticipate,” “mightestimate,” “willexpect,” “objectiveproject,” “intend,” “shouldmay,” “couldplan,” “can,” “would,” “expectpredict,” “believe,” “anticipatepossible,” “project,should“target,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar words or expressions are intended to identify forward-looking statementsstatements although not all forward- looking statements contain these identifying words. These forward-looking statements reflect include statements about, among other things: • developments, projections and trends relating to us, our current views 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 growth we may experience, 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 our 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, including the role of governments in the healthcare industry generally and pressures or incentives to reduce healthcare costs while expanding individual benefits, as well as the impact of general uncertainty in the U.S. healthcare regulatory environment; • our ability to attract, retain and motivate key scientific and management personnel; • our expectations regarding our 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 expense levels and our ability to appropriately forecast and plan our expenses; • our expectations regarding our future capital requirements and our ability to obtain additional capital if and when needed; and • the impact of the above factors and other future events on the market price of our common stock. All forward-looking statements reflect management’s present assumptions, expectations and beliefs regarding future events and are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those expressed in or implied by any forward-looking statements. These risks and uncertainties include those described under the heading “Risk Factors” contained in this prospectus, any related free writing prospectus, and in our most recent annual report on Form 10-K and quarterly 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 subject 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 uncertaintiessuch 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 uncertaintiesrisks, uncertainties and other important factors, 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 revenueYou should carefully read this prospectus, the sufficiency of our cash resources accompanying base prospectus and needs for additional financing; • any related free writing prospectus, together with the rate information incorporated herein 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 therein by the forward-looking statements. Any forward-looking statement made by us in this prospectus speaks only reference 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 described under the heading headings Risk Factors.Where You Can Find More InformationAlso, these forward-looking statements represent our estimates and assumptions only as “Incorporation 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 read this prospectus and the documents that we reference in this prospectus and have filed as exhibits to the registration statement, of which this prospectus is a part, 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. 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: Equity Distribution Agreement

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus contains forward-looking statements that within the meaning of the federal securities laws, which statements involve substantial risks and uncertainties. The Forward-looking statements generally relate to future events or our future financial or operating performance and expectations. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements are contained principally in “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business.” statements. In some cases, you can identify forward-looking statements by terms because they contain words such as “may,” “might,” ”, “will,” “objective,” “intend,” ”, “should,” ”, “expects”, “plans”, “anticipates”, “could,” ”, can,” “would,” “expect,” “believe,” “anticipate,” “project,” intends”, “target,” ”, design,” projects”, estimate,” contemplates”, predict,” believes”, “estimates”, “predicts”, “potential,or plancontinue” or the negative of these termswords or other similar terms or expressions that concern our expectations, and similar expressions intended to identify forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertaintiesstrategy, you should not place undue reliance on these forward-looking statementsplans or intentions. Forward-looking statements contained in this prospectus include, but are not limited to, statements about: • the timing ● our future financial and results of enrollment, commencement and completion of operations; ● our clinical trialsgrowth plans; • the timing and success of preclinical studies and clinical trials conducted by us ● our business plan and our development partners; • the ability to obtain and maintain regulatory approval of effectively manage our clinical trials and product candidates, and the labeling for any approved productsgrowth; • 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 and retain key personnelbrands and advertising agencies; ● the effects of increased competition in our market and our ability to establish compete effectively; ● our plans to use the proceeds from this offering; ● estimates of our expenses, future revenues, capital requirements, our needs for additional capital 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 additional capital; ● our ability to attract and maintain intellectual property protection for retain qualified directors, employees and key personnel such as our product candidatesfounders while maintaining our corporate culture; ● future acquisitions of or investments in complementary companies; and ● the anticipated effects of trends on, and challenges fluctuations in, our results of operations. We have based the forward-looking statements contained in this prospectus primarily on our current expectations and projections about future events and trends that we believe may affect our business, financial condition, results of operations, prospects, business strategy and 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 section captioned “Risk Factors” and elsewhere in this 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 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 market in which we operate; and • the use or sufficiency of our cash or cash equivalents. Forwardforward-looking statements involve known contained in this prospectus. We cannot assure you that the results, events and unknown riskscircumstances reflected in the forward-looking statements will be achieved or occur, uncertainties and other factors which may cause our actual results, performance events or achievements to be circumstances could differ materially different from any future results, performances or achievements expressed or implied by those described in the forward-looking statements. Any forward-looking statement made by 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 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, 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. Unless required by United States federal securities lawsThese statements are inherently uncertain, we do and investors are cautioned not intend to update any of unduly rely upon these statements. The forward-looking statements to reflect circumstances or events that occur after the statement is made. You should read this prospectus and the documents that we reference made in this prospectus and have filed relate only to events as exhibits to of the registration statement, of date on which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we expectsuch statements are made. We qualify all of our undertake no obligation to update any forward-looking statements after the date of this prospectus or to conform such statements to actual results or revised expectations, except as required by these cautionary statementslaw. This prospectus includes statistical As a condition to Investor’s Subscription, the Investor represents, warrants, acknowledges and other industry agrees that the following are true as of the date written below, as of the date of Closing and market data which representations, warranties, and covenants shall survive the Closing, and acknowledges that we obtained from industry publications 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 researchis not acquiring the Tokens for the account or benefit of any U.S. person. C-2.2. Investor acknowledges the Company may 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, surveys the buyer must be outside the United States, or the seller 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 its behalf are expressly qualified in their entirety by reasonably believe that the cautionary statements contained buyer is outside the United States; or referred to in (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 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 obligationRolling SAFE, and specifically decline 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 obligation, advertisement in a publication with a general circulation in the United States (as defined in Rule 902 of Regulation S) that refers to update the Tokens or revise publicly any forward-looking statements, whether the offer or sale of the Tokens. Investor acknowledges that it is not acquiring the Tokens as a result of, any "directed selling efforts" (as defined in Rule 902 of new informationRegulation 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, future events or otherwise. In additionand that the Company is relying, you should refer 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 section Company and the eligibility of this prospectus entitled “Risk Factors” as well as Investor to acquire 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 statementsTokens. As a result of these factors, we cannot assure you that the forward-looking statements in this prospectus will prove to be accurateC-2.5. 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.Investor agrees that:

Appears in 1 contract

Samples: Rolling Safe

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus contains 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-looking statements that involve risks and uncertainties. The to be covered by the safe harbor provisions for forward-looking statements are contained principally in the Private Securities Litigation Reform Act of 1995. Words such as Prospectus Summaryanticipate,” “Risk Factorsestimate,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business.” In some cases, you can identify forward-looking statements by terms such as “mayexpect,” “might,” “will,” “objectiveproject,” “intend,” “shouldmay,” “couldplan,” “can,” “would,” “expectpredict,” “believe,” “anticipatepossible,” “project,should“target,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar words or expressions are intended to identify forward-looking statementsstatements although not all forward- looking statements contain these identifying words. These forward-looking statements reflect include statements about, among other things: • developments, projections and trends relating to us, our current views 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 growth we may experience, 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 our 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, including the role of governments in the healthcare industry generally and pressures or incentives to reduce healthcare costs while expanding individual benefits, as well as the impact of general uncertainty in the U.S. healthcare regulatory environment; • our ability to attract, retain and motivate key scientific and management personnel; • our expectations regarding our 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 expense levels and our ability to appropriately forecast and plan our expenses; • our expectations regarding our future capital requirements and our ability to obtain additional capital if and when needed; and • the impact of the above factors and other future events on the market price of our common stock. All forward-looking statements reflect management’s present assumptions, expectations and beliefs regarding future events and are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those expressed in or implied by any forward-looking statements. These risks and uncertainties include those described 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 quarterly 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 subject 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 uncertaintiessuch 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 uncertaintiesrisks, uncertainties and other important factors, 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 revenueYou should carefully read this prospectus, the sufficiency of our cash resources applicable prospectus supplement and needs for additional financing; • any related free writing prospectus, together with the rate information incorporated herein 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 therein by the forward-looking statements. Any forward-looking statement made by us in this prospectus speaks only reference 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 described under the heading “Risk Factors.Where You Can Find More Information,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 read this prospectus and the documents that we reference in this prospectus and have filed as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what 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. 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: Equity Distribution Agreement

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus contains forward-and the documents we have filed with the SEC that are incorporated by reference contain “forward- looking statements that involve risks statements” within the meaning of Section 27A of the Securities Act, and uncertainties. The forward-looking statements are contained principally in “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and Analysis Section 21E of Financial Condition and Results the Securities Exchange Act of Operations” and “Business.” In some cases1934, 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,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statementsExchange Act. These statements reflect our current views with respect relate to future events or to our future operating or financial performance and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, 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 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 serve those markets; • the 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 statement made statements by us in this prospectus speaks only terms such as of the date “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “potential” and similar expressions intended to identify forward-looking statements. These statements reflect our current views with respect to future events and are based on which it is madeassumptions and are subject to risks and uncertainties. Except as required by lawGiven these uncertainties, we assume no obligation to update you should not place undue reliance on these statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. We discuss in greater detail many of these risks in this prospectus in greater detail under the heading “Risk Factors.contained in the applicable prospectus supplement, in any free writing prospectuses we may authorize for use in connection with a specific offering, and in our most recent annual report on Form 10-K and in our most recent quarterly report on Form 10-Q, as well as any amendments thereto reflected in subsequent filings with the SEC, which are incorporated by reference into this prospectus in their entirety. Also, these forward-looking statements represent our estimates and assumptions only as of the date of this prospectusthe document containing the applicable statement. Unless required by United States federal securities lawslaw, we do not intend undertake no obligation to update or revise any of these forward-looking statements to reflect circumstances new information or future events or developments. Thus, you should not assume that occur after the statement is madeour silence over time means that actual events are bearing out as expressed or implied in such forward- looking statements. You should read this prospectus, any applicable prospectus and supplement, together with the documents we have filed with the SEC that are incorporated by reference and any free writing prospectus that we reference may authorize for use in connection with this prospectus and have filed as exhibits to the registration statement, of which this prospectus is a part, offering completely and with the understanding that our actual future results may be materially different from what we expect. 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 the foregoing documents by these cautionary statements. 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 prospectus will prove 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 accurateadopted by cytogenetics labs that seek to use it in commercial clinical tests of its patients as a laboratory-developed test, or LDT. FurthermoreWe estimate that approximately 2,500 cytogenetics labs exist worldwide. These labs currently rely on existing methods such as karyotyping, if our forwardfluorescence 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-looking statements prove 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 inaccurateused 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 inaccuracy may be materialBionano Support team will install the Saphyr System on the customer’s premises and provide training on sample preparation, instrument operation and data analysis. In light 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 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 allcustomer’s project.

Appears in 1 contract

Samples: At Market Issuance Sales Agreement

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus contains supplement and the accompanying prospectus and the information incorporated by reference in this prospectus supplement and the accompanying prospectus contain “forward-looking statements that involve risks and uncertainties. The forward-looking statements are contained principally in “Prospectus Summarystatements,” “Risk Factors,” “Management’s Discussion which include information relating to future events, future financial performance, strategies, expectations, competitive environment and Analysis of Financial Condition and Results of Operations” and “Business.” In some cases, you can identify forward-looking statements by terms regulation. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design,” “estimate,” “predictpredicts,” “potential,” “plancontinue,or the negative of these terms, “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” and similar expressions intended to expressions, as well as statements in future tense, identify forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these 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, statements about: • our history of recurring losses and negative cash flows from operating activities and the timing of enrollment, commencement and completion uncertainty regarding the adequacy of our clinical trialsliquidity to pursue or complete our business objectives, and substantial doubt regarding our ability to continue as a going concern; • the timing results of ongoing and success of preclinical studies and future clinical trials conducted by us and our development partnersstudies; • the ability our inability 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 successfully develop or commercialize our product candidates; • the size market acceptance of existing and growth of the potential markets for our product candidates and the ability to serve those marketsnew products; • our expectations regarding our expenses inability to carry out research, development 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 candidatescommercialization plans; • our expectations regarding competitioninability to complete preclinical testing and clinical trials as anticipated; • changes in our anticipated growth strategiesrelationship with key collaborators; • our ability to attract 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 retain key personnelat 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 establish and maintain development partnershipsthe listing of our common stock on The Nasdaq Capital Market; • our expectations regarding federalbusiness, state results of operations and foreign regulatory requirementsfinancial condition may be adversely impacted by public health epidemics, including the recent COVID-19 outbreak; • regulatory developments in the United States and foreign countriesloss of one or more key executives; • difficulties in securing and retaining regulatory approval to market our ability to obtain product and maintain intellectual property protection for our product candidates; and depth of the anticipated trends 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 challenges in other risks that relate to our business and the market investing in which we operate; and • the use or sufficiency of our cash or cash equivalentssecurities. 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 The forward-looking statements represent our estimates and assumptions only as of the date of this prospectus. Unless required contained or incorporated 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 read this prospectus and the documents that we reference in this prospectus and have filed as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we expect. 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 supplement are expressly qualified in their entirety by the this cautionary statements contained or referred statement. Except as required by applicable law, we do not undertake any obligation to in this section. We caution investors not to rely too heavily on the publicly update any forward-looking statements we make statement contained in this prospectus supplement, the accompanying prospectus or that are the documents incorporated by reference herein to reflect events or circumstances after the date on which any such statement is made on our behalfor to reflect the occurrence of unanticipated events. We undertake no obligation, and specifically decline any obligation, to update or revise publicly any For all forward-looking statements, whether as a result we claim the protection 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 safe harbor 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 contained in the Private Securities Litigation Reform Act of 1995. 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. 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 prospectus will prove offering, the actual total public offering amount, commissions and proceeds to be accurate. Furthermoreus, if our forward-looking statements prove to any, are not determinable at this time. There can 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 no assurance that we will achieve our objectives and plans in sell any specified time frameshares under, or at allfully 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 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 timing of our actual expenditures will depend upon numerous factors, including the amount of cash generated by our operations, the 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, we evaluate these and other factors and we anticipate continuing to make such evaluations to determine if the existing allocation of resources, including the proceeds of this offering, is being optimized. Circumstances that may give rise to a change in the use of proceeds include: ● a change in development plan or strategy; ● the addition of new products or applications; ● technical delays; ● delays or difficulties with our clinical trials; ● negative results from our clinical trials; ● difficulty obtaining U.S. Food and Drug Administration approval; and ● the availability of other sources of cash including additional offerings, if any.

Appears in 1 contract

Samples: Open Market Sale Agreement

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus contains forward-looking statements that within the meaning of the federal securities laws, which statements involve substantial risks and uncertainties. The Forward-looking statements generally relate to future events or our future financial or operating performance and expectations. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements are contained principally in “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business.” statements. In some cases, you can identify forward-looking statements by terms because they contain words such as “may,” “might,” ”, “will,” “objective,” “intend,” ”, “should,” ”, “expects”, “plans”, “anticipates”, “could,” ”, can,” “would,” “expect,” “believe,” “anticipate,” “project,” intends”, “target,” ”, design,” projects”, estimate,” contemplates”, predict,” believes”, “estimates”, “predicts”, “potential,or plancontinue” or the negative of these termswords or other similar terms or expressions that concern our expectations, and similar expressions intended to identify forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertaintiesstrategy, you should not place undue reliance on these forward-looking statementsplans or intentions. Forward-looking statements contained in this prospectus include, but are not limited to, statements about: • the timing ● our future financial and results of enrollment, commencement and completion of operations; ● our clinical trialsgrowth plans; • the timing and success of preclinical studies and clinical trials conducted by us ● our business plan and our development partners; • the ability to obtain and maintain regulatory approval of effectively manage our clinical trials and product candidates, and the labeling for any approved productsgrowth; • 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 and retain key personnelbrands and advertising agencies; ● the effects of increased competition in our market and our ability to establish compete effectively; ● our plans to use the proceeds from this offering; ● estimates of our expenses, future revenues, capital requirements, our needs for additional capital 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 additional capital; ● our ability to attract and maintain intellectual property protection for retain qualified directors, employees and key personnel such as our product candidatesfounders while maintaining our corporate culture; ● future acquisitions of or investments in complementary companies; and ● the anticipated effects of trends on, and challenges fluctuations in, our results of operations. We have based the forward-looking statements contained in this prospectus primarily on our current expectations and projections about future events and trends that we believe may affect our business, financial condition, results of operations, prospects, business strategy and 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 section captioned “Risk Factors” and elsewhere in this 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 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 market in which we operate; and • the use or sufficiency of our cash or cash equivalents. Forwardforward-looking statements involve known contained in this prospectus. We cannot assure you that the results, events and unknown riskscircumstances reflected in the forward-looking statements will be achieved or occur, uncertainties and other factors which may cause our actual results, performance events or achievements to be circumstances could differ materially different from any future results, performances or achievements expressed or implied by those described in the forward-looking statements. Any forward-looking statement made by 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 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, 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. Unless required by United States federal securities lawsThese statements are inherently uncertain, we do and investors are cautioned not intend to update any of unduly rely upon these statements. The forward-looking statements to reflect circumstances or events that occur after the statement is made. You should read this prospectus and the documents that we reference made in this prospectus and have filed relate only to events as exhibits to of the registration statement, of date on which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we expectsuch statements are made. We qualify all of our undertake no obligation to update any 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 after 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 date 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 or to conform such statements to actual results to differ materially from those expressed or implied revised expectations, except as required by our forward-looking statementslaw. As a result condition to Investor’s Subscription, the Investor represents, warrants, acknowledges and agrees that the following are true as of these factorsthe date written below, we 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 assure you that be sold, transferred or otherwise disposed of by the forward-looking statements in this prospectus will prove to be accurateInvestor 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. Furthermore, if our forward-looking statements prove to be inaccurateTherefore, the inaccuracy may be materialInvestor must bear the economic risk of an investment in such Tokens for an indefinite period. In light 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 significant uncertainties in these forward-looking statementsTokens, you should not regard these statements except as a representation or warranty by us or disclosed to the Company on an attachment hereto. To the extent any other person that we has any such beneficial interest, the Company will achieve our objectives and plans in any specified time frame, or at allrequire such persons to execute a signature page to this Rolling SAFE.

Appears in 1 contract

Samples: Rolling Safe

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS. This prospectus contains supplement and the accompanying prospectus contain and/or incorporate by reference statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These forward-looking statements that involve risks and uncertainties. The contain projections of our future results of operations or of our financial position or state other forward-looking information. In some cases you can identify these statements are contained principally in by forward-looking words such as Prospectus Summaryanticipate,” “Risk Factorsbelieve,” “Management’s Discussion and Analysis of Financial Condition and Results of Operationscould,and Business.continue,In some cases, you can identify forward-looking statements by terms such as “estimate,” “expect,” “forecast,” “intend,” “may,” “mightshould,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipateplan,” “project,” “target,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and such words or other similar expressions intended words or phrases. We believe that it is important to identify forward-looking statementscommunicate our future expectations to our investors. These statements reflect our current views with respect to However there may be events in the future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Forward-looking statements include, but that we are not limited to, statements about: • the timing of enrollment, commencement able to accurately predict or control 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 read this prospectus and the documents that we reference in this prospectus and have filed as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we expect. 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 the expectations we describe in our forward-looking statements. As a result of these factors, we canInvestors are cautioned not assure you that the to unduly rely on forward-looking statements because they involve risks and uncertainties, and results may differ materially from those discussed as a result of various factors, including, but not limited to: the risk that we continue to incur losses and might never achieve or maintain profitability; the risk that we will need to raise additional capital to fund our operations and such capital may not be available to us; the risks associated with global economic uncertainty, including inflationary pressures, fluctuating interest rates, currency fluctuations, bank failure, and supply chain disruptions; the risk that we may not be able to obtain from our hydrogen suppliers a sufficient supply of hydrogen at competitive prices or the risk that we may not be able to produce hydrogen internally at competitive prices; the risk that we may not be able to expand our business or manage our future growth effectively; the risk that delays in or not completing our product development and hydrogen plant construction goals may adversely affect our revenue and profitability; the risk with regards to the impact of the Inflation Reduction Act on our business; the risk that we may be unable to successfully pursue, integrate, or execute upon our new business ventures; the risk of dilution to our stockholders and/or stock price should we need to raise additional capital; the risk that our lack of extensive experience in manufacturing and marketing of certain of our products may impact our ability to manufacture and market said products on a profitable and large-scale commercial basis; the risk that unit orders may not ship, be installed and/or converted to revenue, in whole or in part; the risk that a loss of one or more of our major customers could result in a material adverse effect on our financial condition, or if one of our major customers delays payment of or is unable to pay its receivables, a material adverse effect could result on our financial condition; the risk that we may not be able to convert all of our estimated future revenue into revenue and cash flows; the risk that a sale or issuance of a significant number of shares of stock could depress the market price of our common stock; the risk that our convertible senior notes, if settled in cash, could have a material adverse effect on our financial results; the risk that our convertible note xxxxxx may affect the value of our convertible senior notes and our common stock; the risk that negative publicity related to our business or stock could result in a negative impact on our stock value and profitability; the risk of potential losses related to any product liability claims or contract disputes; the risk of loss related to an inability to remediate the material weaknesses identified in internal control over financial reporting as of December 31, 2022 and 2021, or inability to otherwise maintain an effective system of internal control over financial reporting; our ability to attract and retain key personnel; the risks related to the use of flammable fuels in our products; the risk that pending orders may not convert to purchase orders, in whole or in part; the cost and timing of developing, marketing, and selling our products; the risks involved with participating in joint ventures, including our ability or inability to execute our strategic growth plan through joint ventures; our ability to obtain financing arrangements to support the sale or leasing of our products and services to customers; our ability to achieve the forecasted revenue and costs on the sale of our products; the cost and availability of fuel and fueling infrastructures for our products; the risks, liabilities, and costs related to environmental, health and safety matters; the risk of elimination or reduction of government subsidies and economic incentives for alternative energy products; market acceptance of our products and services; our ability to establish and maintain relationships with third parties with respect to product development, manufacturing, distribution and servicing, and the supply of key product components; the cost and availability of components and parts for our products; the risk that possible new tariffs could have a material adverse effect on our business; our ability to continue as a going concern, including our ability to raise sufficient funds to fund our operations through the next 12 months from the date of our Quarterly Report for the quarterly period ended September 30, 2023; the risk that some or all of the recorded goodwill, intangible assets and property, plant, and equipment could be subject to impairment; our ability to develop commercially viable products; our ability to reduce product and manufacturing costs; our ability to successfully market, distribute and service our products and services internationally; our ability to improve system reliability for our products; competitive factors, such as price competition and competition from other traditional and alternative energy companies; our ability to protect our intellectual property; our operational dependency on information technology and the risk of the failure of such technology, including failure to effectively prevent, detect, and recover from security compromises or breaches, including cyber-attacks; the cost of complying with current and future federal, state and international governmental regulations; the expense and resources associated with being subject to legal proceedings and legal compliance; the risks associated with past and potential future acquisitions; the risks associated with geopolitical instability, including the conflicts between Israel and Hamas and Russia and Ukraine; and the volatility of our stock price. The risks included here are not exhaustive, and additional factors could adversely affect our business and financial performance, including factors and risks referenced under “Risk Factors” of this prospectus will prove supplement and in the accompanying prospectus or any free writing prospectus provided in connection with this offering and any documents incorporated by reference herein or therein, including our Annual Report on Form 10-K for the year ended December 31, 2022, our Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2023, June 30, 2023 and September 30, 2023, as well as any amendment or update to be accurateour risk factors reflected in subsequent filings with the SEC. FurthermoreWe operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time and it is not possible for management to predict all such risk factors, if nor can we assess the impact of all such risk factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from these contained in any forward-looking statements. While forward-looking statements prove to be inaccuratereflect our good faith beliefs, they are not guarantees of future performance. These forward-looking statements speak only as of the inaccuracy date on which the statements were made. Except as may be material. In light required by applicable law, we do not undertake or intend to update any forward-looking statements after the date of this prospectus supplement or the significant uncertainties respective dates of documents incorporated herein or therein or any free writing prospectus provided in these connection with this offering that include 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: At Market Issuance Sales Agreement

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