Capricor Therapeutics Inc 2025年季度报告

UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWASHINGTON, D.C. 20549 FORM 10-Q ☒Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934for the quarterly period ended March 31, 2025or Commission File Number: 001-34058 (Exact Name Of Registrant As Specified In Its Charter) Securities registered pursuant to Section 12(b) of the Act: Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) ofthe Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrantwas required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.☒Yes☐No Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to besubmitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or forsuch 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,a smaller reporting company, 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 ExchangeAct. Large accelerated filer☐Non-acceleratedfiler☒ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extendedtransition period for complying with any new or revised financial accounting standards provided pursuant toSection 13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).☐Yes☒No As of May 13, 2025, there were 45,707,819 shares of the registrant’s common stock, par value $0.001 pershare, issued and outstanding. INDEX TO QUARTERLY REPORT ON FORM 10-Q PART I. FINANCIAL INFORMATIONItem 1. Financial Statements5Condensed Consolidated Balance Sheets as of March 31, 2025 and December 31, 20245Condensed Consolidated Statements of Operations and Comprehensive Loss for the ThreeMonths Ended March 31, 2025 and 20246Condensed Consolidated Statements of Changes in Stockholders’ Equity for the ThreeMonths Ended March 31, 2025 and 20247Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31,2025 and 20248Notes to Unaudited Condensed Consolidated Financial Statements9Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations28Item 3. Quantitative and Qualitative Disclosures about Market Risk41Item 4. Controls and Procedures42PART II. OTHER INFORMATIONItem 1. Legal Proceedings43Item 1A. Risk Factors43Item 2. Unregistered Sales of Equity Securities and Use of Proceeds43Item 3. Defaults Upon Senior Securities43Item 4. Mine Safety Disclosures43Item 5. Other Information43Item 6. Exhibits43Signatures45 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS ThisQuarterlyReportonForm 10-Qcontainsforward-lookingstatementswithinthemeaningofSection 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, asamended, which statements involve substantial risks and uncertainties. Forward-looking statements generally relateto future events or our future financial or operating performance. In some cases, you can identify forward-lookingstatements because they contain words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,”“intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or thenegative of these words or other similar terms or expressions that concern our expectations, strategy, plans orintentions. Forward-looking statements contained in this Quarterly Report on Form 10-Q include, but are not limitedto, statements about: ●how long we expect to maintain liquidity to fund our planned level of operations and our ability toobtain additional funds for our operations;●the development of our drug and vaccine candidates, including when we expect to undertake, initiateand complete clinical trials of our drug and vaccine candidates;●the expectation, plans, projections, initiation, timing, progress and results of our research anddevelopment programs, preclinical studies, any clinical trials, compassionate uses, InvestigationalNew Drug filings, Clinical Trial Application filings, New Drug Application filings, Biologics LicenseApplication, and other regulatory submissions;●regulatory developments involving products and our facilities, including the timing and results ofregulatory meetings and inspections, and the ability to obtain regulatory approvals or otherwise bringproducts to market;●the impact of any reductions in force or changes in regulatory priorities at the U.S. federal agenciesresponsible for overseeing our industry;●the regulatory status of our drug and v