Capricor Therapeutics Inc 2024年度报告

þAnnual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934for the fiscal year ended December 31, 2024 or 10865 Road to the Cure, Suite 150, San Diego, California 92121(Address of principal executive offices including zip code) (858) 727-1755(Registrant’s telephone number, including area code) 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 þ No Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.◻Yes þ 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 Actof 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subjectto such filing requirements for the past 90 days. þ Yes◻No Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant toRule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was requiredto submit such files). Yes þ No◻ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reportingcompany, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and“emerging growth company” in Rule 12b-2 of the Exchange Act. If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying withany new or revised financial accounting 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 itsinternal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accountingfirm 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 includedin the filing reflect the correction 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 compensationreceived by any of the registrant'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 þ No The aggregate market value of the registrant’s common stock held by non-affiliates of the registrant as of June 30, 2024 was approximately$140,049,986, based on the last reported sale of the registrant’s common stock on The Nasdaq Capital Market on June 28, 2024 of $4.77 pershare. As of March 24, 2025, there were 45,676,202 shares of the registrant’s common stock, par value $0.001 per share, issued and outstanding. TABLE OF CONTENTS Page Part I Item 1.Business2Item 1A.Risk Factors28Item 1B.Unresolved Staff Comments71Item 1C.Cybersecurity71Item 2.Properties72Item 3.Legal Proceedings72Item 4Mine Safety Disclosures72 Part II73Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and IssuerPurchases of Equity Securities73Item 6.Reserved73Item 7.Management’s Discussion and Analysis of Financial Condition and Results ofOperations74Item 7A.Quantitative and Qualitative Disclosures About Market Risk87Item 8.Financial Statements and Supplementary Data88Item 9.Changes in and Disagreements with Accountants on Accounting and FinancialDisclosure114Item 9A.Controls and Procedures114Item 9B.Other Information115Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections115 Part III Item 10.Directors, Executive Officers and Corporate Governance116Item 11.Executive Compensation121Item 12.Security Ownership of Certain Beneficial Owners and Management127Item 13.Certain Relationships and Related Transactions, and Director Independence131Item 14.Principal Accountant Fees and Services133 Part IV Item 15.Exhibits and Financial Statement Schedules134Item 16.Form 10-K Summary139 SIGNATURES140INDEX OF EXHIBITS FILED WITH THIS REPORT References to “the Company,” “Capricor Therapeutics,” “we,” “us” or “our” in this Annual Report onForm 10-K refer to Capricor Therapeutics, Inc., a Delaware corporation, and its subsidiaries, unless the contextindicates otherwise. References to “Capricor” in this Annual Report on Form 10-K refer to our wholly ownedsubsidiary, Capricor, Inc., unless the context indicates otherwise. FORWARD-LOOKING STATEMENTS ThisAnnual Repo