Tenaya Therapeutics Inc 2024年度报告

(Mark One)☒☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the fiscal year ended December 31, 2024OR☐☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934FOR THE TRANSITION PERIOD FROM___________TO___________Commission File Number 001-40656 TENAYA THERAPEUTICS, INC.(Exact name of Registrant as specified in its Charter) Delaware81-3789973(State or other jurisdiction ofincorporation or organization)(I.R.S. EmployerIdentification No.)171 Oyster Point Boulevard, Suite 500South San Francisco, CA94080(Address of principal executive offices)(Zip Code)Registrant’s telephone number, including area code: (650) 825-6990 Securities registered pursuant to Section 12(b) of the Act: 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 the preceding12 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 90 days. Yes☒No☐ (§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 the Exchange Act. Large accelerated filer☐Accelerated filer☐Non-accelerated filer☒Smaller reporting company☒Emerging growth company☒ 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 revised financialaccounting standards provided pursuant to Section 13(a) of the Exchange Act.☐ Indicate by check mark whether the Registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financialreporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.☐ 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 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 common stock onthe Nasdaq Global Select Stock Market on June 30, 2024 was approximately $170.5 million. Table of Contents PART I Item 1.Business3Item 1A. Risk Factors36Item 1B. Unresolved Staff Comments89Item 1C. Cybersecurity89Item 2.Properties90Item 3.Legal Proceedings90Item 4.Mine Safety Disclosures91 PART II Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases ofEquity Securities92Item 6.Reserved92Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations93Item 7A. Quantitative and Qualitative Disclosures About Market Risk102Item 8.Financial Statements and Supplementary Data103Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure126Item 9A. Controls and Procedures126Item 9B. Other Information127Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections127 PART III Item 10.Directors, Executive Officers and Corporate Governance128Item 11.Executive Compensation128Item 12.Security Ownership of Certain Beneficial Owners and Management and Related StockholderMatters128Item 13.Certain Relationships and Related Transactions, and Director Independence128Item 14.Principal Accounting Fees and Services128 PART IV SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K, or Annual Report, contains forward-looking statements within themeaning of Section 27A of the Securities Act of 1933, as amended (Securities Act) and Section 21E of theSecurities Exchange Act of 1934, as amended (Exchange Act). All statements other than statements of historicalfacts contained in this Annual Report, including statements regarding our future results of operations and financialposition, business strategy, development plans, planned preclinical studies and clinical trials, future results ofclinical trials, expected research and development cost