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| | PART I | |
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| Item 1. | Business | 4 |
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| Item 1A. | Risk Factors | 23 |
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| Item 1B. | Unresolved Staff Comments | 62 |
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| Item 1C. | Cybersecurity | 63 |
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| Item 2. | Properties | 65 |
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| Item 3. | Legal Proceedings | 65 |
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| Item 4. | Mine Safety Disclosures | 65 |
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| | PART II | |
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| Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 65 |
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| Item 6. | Reserved | 65 |
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| Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 66 |
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| Item 7A. | Quantitative and Qualitative Disclosures About Market Risk | 77 |
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| Item 8. | Financial Statements and Supplementary Data | 78 |
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| Item 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 114 |
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| Item 9A. | Controls and Procedures | 114 |
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| Item 9B. | Other Information | 115 |
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| Item 9C. | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 115 |
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| | PART III | |
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| Item 10. | Directors, Executive Officers and Corporate Governance | 115 |
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| Item 11. | Executive Compensation | 116 |
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| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 116 |
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| Item 13. | Certain Relationships and Related Transactions, and Director Independence | 116 |
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| Item 14. | Principal Accountant Fees and Services | 116 |
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| | PART IV | |
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| Item 15. | Exhibits and Financial Statement Schedules | 117 |
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Summary of Principal Risk Factors
This summary briefly lists the principal risks and uncertainties facing our business, which are only a select portion of those risks. A more complete discussion of those risks and uncertainties is set forth in Part I, Item 1A of this Annual Report, entitled “Risk Factors”. Additional risks not presently known to us or that we currently deem immaterial may also affect us. If any of these risks occur, our business, financial condition or results of operations could be materially and adversely affected.
Our business is subject to the following principal risks and uncertainties:
Risks Associated with Development and Commercialization of Our Drug Candidates
| ● | The cost, time, and possibility of delays associated with clinical trials, which may be required to continue beyond our available funding. We cannot be certain that we will be able to raise sufficient funds to complete the development and commercialize our remaining product candidates currently in clinical development, should they succeed. |
| ● | We may suffer significant delays, setbacks or negative results in, or termination of, our clinical trials. |
| ● | We are making use of biomarkers, which are not scientifically validated, and our reliance on biomarker data may thus cause us to direct our resources inefficiently. |
| ● | We may be unable to directly control the timing, conduct and expense of our clinical trials, due to our reliance on contract research organizations and other third parties to conduct clinical trials. |
| ● | We have no manufacturing capacity and will rely on third party manufacturers for the late-stage clinical trials, development and commercialization of any drugs we may develop or sell. |
| ● | We may encounter difficulties in managing our growth and expanding our operations successfully as we evolve from a company primarily involved in discovery and development to one also involved in the commercialization of drugs and devices. |
| ● | Our drug candidates are subject to extensive regulation, which can be costly and time-consuming, and we may not obtain approvals for the commercialization of any of our drug candidates. |
| ● | Even if we successfully complete the clinical trials for our current product candidate, the product candidate may fail for other reasons. |
| ● | We face intense competition and our competitors may develop drugs that are less expensive, safer, or more effective than our drug candidates. |
| ● | If we fail to enter into and maintain successful strategic alliances for our drug candidates, we may have to reduce or delay our drug candidate development or increase our expenditures. |
| ● | If our drug candidates or distribution partners’ products fail to achieve market acceptance, we may not be able to generate significant revenue and our business may suffer. Our business may be affected by the efforts of government and third-party payors to contain or reduce the cost of healthcare through various means. |
| ● | We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability for a product candidate and may have to limit its commercialization. |
| ● | We may be subject to numerous and varying privacy and security laws, and our failure to comply could result in penalties and reputational damage. |
Risks Related to Our Business and Financial Condition
| ● | We have a history of operating losses and we may never become profitable. Our stock is a highly speculative investment. |
| ● | There is substantial doubt regarding our ability to continue as a going concern. We will need to raise additional capital in upcoming periods which may not be available to us on reasonable terms, if at all. |
| ● | Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price. |
| ● | If we fail to comply with the continued listing requirements of the Nasdaq Capital Market, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted. |
| ● | Funding constraints may negatively impact our research and development activities, forcing us to delay our efforts to develop our only current product candidate, plogosertib (“plogo”), which may prevent us from commercializing our product candidate as quickly as possible. |
| ● | We are experiencing an increasingly tight and competitive labor market with an increase in employee turnover rates and higher compensation and hiring costs. This may have an adverse effect on our ability to attract and retain skilled personnel and may harm our business. |
Risks Related to our Intellectual Property
| ● | If we fail to enforce adequately or defend our intellectual property rights, our business may be harmed. |
| ● | We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights. |
Risks Related to Securities Regulations and Investment in Our Securities
| ● | Failure to achieve and maintain internal controls in accordance with Sections 302 and 404 of the Sarbanes-Oxley Act of 2002 could have a material adverse effect on our business and stock price. |
| ● | We incur increased costs and management resources as a result of being a public company, and we may fail to comply with public company obligations. |
| ● | We may have limited ability to pay cash dividends on our preferred stock, and there is no assurance that future quarterly dividends will be declared. |
| ● | The future sale of our common and convertible preferred stock and future issuances of our common stock upon conversion of our preferred stock could negatively affect our stock price and cause dilution to existing holders of our common stock. |
| ● | The number of shares of common stock which are registered, including the shares to be issued upon exercise of our outstanding warrants, is significant in relation to our currently outstanding common stock and could cause downward pressure on the market price for our common stock. |
| ● | Our management team will have broad discretion over the use of the net proceeds from any sale of our securities. |
