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| Part I | | | | |
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| Item 1. | | Business | | 1 |
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| Item 1A. | | Risk Factors | | 26 |
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| Item 1B. | | Unresolved Staff Comments | | 57 |
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| Item 1C. | | Cybersecurity | | 57 |
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| Item 2. | | Properties | | 58 |
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| Item 3. | | Legal Proceedings | | 58 |
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| Item 4. | | Mine Safety Disclosures | | 58 |
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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 | | 59 |
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| Item 6. | | [Reserved] | | 59 |
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| Item 7. | | Management’s Discussion and Analysis of Financial Condition and Results of Operations | | 60 |
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| Item 7A. | | Quantitative and Qualitative Disclosures About Market Risk | | 81 |
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| Item 8. | | Financial Statements and Supplementary Data | | 82 |
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| Item 9. | | Changes in and Disagreements With Accountants on Accounting and Financial Disclosure | | 105 |
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| Item 9A. | | Controls and Procedures | | 105 |
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| Item 9B. | | Other Information | | 106 |
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| Item 9C. | | Disclosure Regarding Foreign Jurisdictions That Prevent Inspections | | 106 |
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| Part III | | | | |
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| Item 10. | | Directors, Executive Officers and Corporate Governance | | 107 |
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| Item 11. | | Executive Compensation | | 107 |
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| Item 12. | | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | | 107 |
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| Item 13. | | Certain Relationships and Related Transactions, and Director Independence | | 107 |
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| Item 14. | | Principal Accountant Fees and Services | | 107 |
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| Part IV | | | | |
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| Item 15. | | Exhibits, Financial Statement Schedules | | 108 |
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| Signatures | | | | 112 |
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Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This Annual Report on Form 10-K contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations, assumptions, estimates, intentions and future performance, and involve known and unknown risks, uncertainties and other factors, which may be beyond our control and which may cause our actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our use of words such as “may,” “will,” “can,” “anticipate,” “assume,” “should,” “indicate,” “would,” “believe,” “contemplate,” “expect,” “seek,” “estimate,” “continue,” “plan,” “point to,” “project,” “predict,” “could,” “intend,” “target,” “potential” and other similar words and expressions of the future.
There are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking statement made by us. These factors include, but are not limited to:
| ● | our dependence on product candidates that are still in development stages; |
| ● | our ability to successfully complete research and further development, including preclinical and clinical studies; |
| ● | our anticipated timing for preclinical development, regulatory submissions, commencement and completion of clinical trials and product approvals; |
| ● | our ability to commercialize our drug candidates and the growth of the markets for those drug candidates; |
| ● | our ability to develop and commercialize products before competitors that are superior to the alternatives developed by such competitors; |
| ● | our ability to negotiate strategic partnerships, where appropriate, for our drug candidates; |
| ● | our ability to manage multiple clinical trials for a variety of drug candidates at different stages of development; |
| ● | the cost, timing, scope and results of ongoing preclinical and clinical testing; |
| ● | our expectations of the attributes of our product and development candidates, including pharmaceutical properties, efficacy, safety and dosing regimens; |
| ● | the cost, timing and uncertainty of obtaining regulatory approvals for our drug candidates; |
| ● | the availability, cost, delivery and quality of clinical management services provided by our clinical research organization partners; |
| ● | the availability, cost, delivery and quality of clinical and commercial-grade materials produced by our own manufacturing facility or supplied by contract manufacturers, suppliers and partners; |
| ● | our ability to develop technological capabilities, including identification of novel and clinically important targets, exploiting our existing technology platforms to develop new drug candidates and expand our focus to broader markets for our existing targeted therapeutics; |
| ● | the cost of paying the regulatory approval milestone under the merger agreement by which we acquired Kolltan Pharmaceuticals, Inc. (“Kolltan”) and our related settlement agreement with Kolltan; |
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| ● | our ability to raise sufficient capital to fund our preclinical and clinical studies and to meet our long-term liquidity needs, on terms acceptable to us, or at all. If we are unable to raise the funds necessary to meet our long-term liquidity needs, we may have to delay or discontinue the development of one or more programs, discontinue or delay ongoing or anticipated clinical trials, discontinue or delay our commercial manufacturing efforts, discontinue or delay our efforts to expand into additional indications for our drug product candidates, license out programs earlier than expected, raise funds at significant discount or on other unfavorable terms, if at all, or sell all or part of our business; |
| ● | our ability to protect our intellectual property rights and our ability to avoid intellectual property litigation, which can be costly and divert management time and attention; |
| ● | our ability to develop and commercialize products without infringing the intellectual property rights of third parties; and |
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this report or the date of the document incorporated by reference into this report. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise. We have expressed our expectations, beliefs and projections in good faith, and we believe they have a reasonable basis. However, we cannot assure you that our expectations, beliefs or projections will result or be achieved or accomplished.
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