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Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES☐NO☒ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. YES☐NO☒ Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90days. YES☒NO☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T(§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). YES☒NO☐Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growthcompany. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of theExchange Act. Accelerated filer☐Smaller reporting company☒Emerging growth company☒ Large accelerated filer☐Non-accelerated filer☒ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revisedfinancial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐ If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect thecorrection of an error to previously issued financial statements.☐ Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of theregistrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES☐NO☒ The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant, based on the closing price of the shares of the registrant’scommon stock on the Nasdaq Capital Marketon June 28, 2024, the last business day of the registrant’s most recently completed second fiscal quarter, was $12.3 million.The number of shares of registrant’s common stock outstanding as of March 14, 2025 was 1,322,359. DOCUMENTS INCORPORATED BY REFERENCE The registrant intends to file a definitive proxy statement pursuant to Regulation 14A relating to the registrant’s 2025 Annual Meeting of Stockholders within 120 days ofthe end of the registrant’s fiscal year ended December 31, 2024. Portions of such definitive proxy statement are incorporated by reference into Part III of this AnnualReport on Form 10-K to the extent stated herein. Table of Contents PART I Item 1.BusinessItem 1A.Risk FactorsItem 1B.Unresolved Staff CommentsItem 1C.CybersecurityItem 2.PropertiesItem 3.Legal ProceedingsItem 4.Mine Safety Disclosures PART II Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of EquitySecurities86Item 6.Reserved86Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations87Item 7A.Quantitative and Qualitative Disclosures About Market Risk98Item 8.Financial Statements and Supplementary Data98Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure98Item 9A.Controls and Procedures98Item 9B.Other Information99Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections99 PART III Item 10.Directors, Executive Officers and Corporate Governance100Item 11.Executive Compensation100Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters100Item 13.Certain Relationships and Related Transactions, and Director Independence100Item 14.Principal Accounting Fees and Services100 PART IV Item 15.Exhibits, Financial Statement SchedulesItem 16Form 10-K Summary 101103 Summary of Material Risks Associated with Our Business Our business is subject to numerous material and other risks and uncertainties that you should be aware of inevaluating our business. These risks include, but are not limited to, the following: •We will require substantial additional capital to finance our operations. If we are unable to raise such capitalwhen needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of ourresearch and drug development programs, future commercialization efforts or other operations.•We have incurred significant net losses since inception, and we expect to continue to incur s