Business Description

5 ​ ​ ​ Item1A. Risk Factors. 30 ​ ​ ​ Item1B. Unresolved Staff Comments. 79 ​ ​ ​ Item1C. Cybersecurity. 79 ​ ​ ​ Item 2. Properties. 80 ​ ​ ​ Item 3. Legal Proceedings. 80 ​ ​ ​ Item 4. Mine Safety Disclosures. 80 ​ ​ Part II. 81 ​ ​ ​ Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. 81 ​ ​ ​ Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations. 81 ​ ​ ​ Item 7A. Quantitative and Qualitative Disclosures About Market Risk. 92 ​ ​ ​ Item 8. Financial Statements and Supplementary Data. 92 ​ ​ ​ Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. 93 ​ ​ ​ Item 9A. Controls and Procedures. 93 ​ ​ ​ Item 9B. Other Information. 93 ​ ​ ​ Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. 93 ​ ​ Part III. 94 ​ ​ ​ Item 10. Directors, Executive Officers and Corporate Governance. 94 ​ ​ ​ Item 11. Executive Compensation. 94 ​ ​ ​ Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. 94 ​ ​ ​ Item 13. Certain Relationships and Related Transactions and Director Independence. 94 ​ ​ ​ Item 14. Principal Accountant Fees and Services. 94 ​ ​ Part IV. 95 ​ ​ ​ Item 15. Exhibits and Financial Statement Schedules. 95 ​ ​ ​ Item 16. Form 10-K Summary. 96 ​ ​ Index to Financial Statements. F-1 ​ ​ Signatures. 98 ​ ​ 1 Table of Contents Cautionary Note Regarding Forward-Looking Statements. This Annual Report on Form 10-K contains express or implied forward-looking statements, within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” “will,” or “would,” and / or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Annual Report on Form 10-K, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. The forward-looking statements in this Annual Report on Form 10-K include, among other things, statements about: ● our cash and cash equivalents balance, runway and needs, as well as financing plans; ● the timing of regulatory submissions; ● our ability to obtain and maintain regulatory approval of our existing product candidates and any other product candidates we may develop, and the labeling under any approval we may obtain; ● our business strategies; ● risks relating to the timing and costs of clinical trials and the timing and costs of other organizational expenses; ● risks related to market acceptance of products; ● risks associated with our reliance on third-party organizations; ● our competitive position; ● assumptions regarding the size of the available market, product pricing and timing of commercialization of our product candidates; ● our intellectual property position and our ability to maintain and protect our intellectual property rights; ● our results of operations, financial condition, liquidity, prospects, and growth strategies; ● the industry in which we operate; and ● the trends that may affect the industry or us. You should refer to Part I,