INDEX TO REPORT ON FORM 10-K
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| | | Page |
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| PART I | 3 | |
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| Item 1: | Business | 3 |
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| Item 1A: | Risk Factors | 30 |
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| Item 1B: | Unresolved Staff Comments | 48 |
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| Item 1C: | Cybersecurity | 48 |
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| Item 2: | Properties | 49 |
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| Item 3: | Legal Proceedings | 49 |
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| Item 4: | Mine Safety Disclosures | 49 |
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| PART II | 50 | |
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| Item 5: | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 50 |
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| Item 6: | Reserved | 50 |
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| Item 7: | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 50 |
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| Item 7A: | Quantitative and Qualitative Disclosures About Market Risk | 57 |
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| Item 8: | Financial Statements and Supplementary Data | 57 |
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| Item 9: | Changes in and Disagreements With Accountants on Accounting and Financial Disclosure | 57 |
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| Item 9A: | Controls and Procedures | 58 |
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| Item 9B: | Other Information | 58 |
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| Item 9C: | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 59 |
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| PART III | 60 | |
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| Item 10: | Directors, Executive Officers and Corporate Governance | 60 |
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| Item 11: | Executive Compensation | 60 |
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| Item 12: | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 60 |
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| Item 13: | Certain Relationships and Related Transactions, and Director Independence | 60 |
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| Item 14: | Principal Accounting Fees and Services | 60 |
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| PART IV | 61 | |
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| Item 15: | Exhibits, Financial Statement Schedules | 61 |
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA
This Annual Report on Form 10-K (Annual Report) includes forward-looking statements. We may, in some cases, use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements appear in a number of places throughout this Annual Report and include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, protection of our intellectual property portfolio, the degree of clinical utility of our products, particularly in specific patient populations, our ability to develop commercial and manufacturing functions, expectations regarding clinical trial data, our results of operations, cash needs, financial condition, liquidity, prospects, growth and strategies, the industry in which we operate and the trends that may affect the industry or us.
By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics and industry change, and depend on the economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Annual Report, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this Annual Report.
You should also read carefully the factors described in the “Risk Factors” section of this Annual Report and elsewhere to better understand the risks and uncertainties inherent in our business and underlying any forward-looking statements. As a result of these factors, actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements in this report and you should not place undue reliance on any forward-looking statements. These factors include, without limitations, the risks related to:
| ● | our need for additional financing for our future clinical trials and other operations, and our ability to obtain sufficient funds on acceptable terms when needed, and our plans and future needs to scale back operations if adequate financing is not obtained; |
| ● | our ability to continue as a going concern; |
| ● | our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; |
| ● | the success and timing of our preclinical studies and clinical trials, including site initiation and patient enrollment, and regulatory approval of protocols for future clinical trials; |
| ● | our ability to enter into, maintain and perform collaboration agreements with other pharmaceutical companies, for funding and commercialization of our clinical drug product candidates or preclinical compounds, and our ability to achieve certain milestones under those agreements; |
| ● | the difficulties in obtaining and maintaining regulatory approval of our product candidates, and the labeling under any approval we may obtain; |
| ● | our plans and ability to develop, manufacture and commercialize our product candidates; |
| ● | our failure to recruit or retain key scientific or management personnel or to retain our executive officers; |
| ● | the size and growth of the potential markets for our product candidates and our ability to serve those markets; |
| ● | regulatory developments in the United States and foreign countries; |
| ● | the rate and degree of market acceptance of any of our product candidates; |
| ● | obtaining and maintaining intellectual property protection for our product candidates and our proprietary technology; |
| ● | the successful development of our commercialization capabilities, including sales and marketing capabilities; |
| ● | recently enacted and future legislation and regulation regarding the healthcare system; |
| ● | the success of competing therapies and products that are or may become available; |
| ● | our ability to maintain the listing of our securities on a national securities exchange; |
| ● | the potential for third party disputes and litigation; and |
| ● | the performance of third parties, including contract research organizations (CROs) and third-party manufacturers. |
Any forward-looking statements that we make in this Annual Report speak only as of the date of such statement, and we undertake no obligation to update such statements to reflect events or circumstances after the date of this Annual Report or to reflect the occurrence of unanticipated events.
