Ernexa Therapeutics Inc 2025年度报告

Form 10-K (Mark One)☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2025 OR ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number 1-11460 Ernexa Therapeutics Inc.(Exact name of registrant as specified in its charter) Delaware31-1103425(State or Other Jurisdiction ofIncorporation or Organization)(I.R.S. EmployerIdentification No.) 1035 Cambridge Street, Suite 18ACambridge, MA02141(Address of Principal Executive Offices)(Zip Code) (617) 798-6700(Registrant’s telephone number, including Area Code) Securities registered pursuant to Section 12(b) of the Act: Name of Each Exchange on Which RegisteredThe Nasdaq Stock Market LLC The Nasdaq Stock Market LLC Common Stock, $0.005 par valueCommon Stock Purchase Warrants ERNAERNAW Securities registered pursuant to Section 12(g) of the Act: None 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 theSecurities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to filesuch reports), and (2) has been subject to 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 for such shorterperiod 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 smallerreporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smallerreporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Large accelerated filer☐Non-accelerated filer☒ 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 periodfor complying with any 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 theeffectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by theregistered 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 theregistrant included in 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 compensation received 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 Act). Yes☐No☒ The aggregate market value of the common stock held by non-affiliates of the registrant as of the last business day of theregistrant’s most recently completed second fiscal quarter (June 30, 2025), computed by reference to the closing sale price of thecommon stock on the Nasdaq Capital Market on such date, was approximately $17.5 million. For purposes of this determinationshares beneficially owned by executive officers, directors and ten percent stockholders have been excluded, which does not representan admission by the registrant as to the affiliate status of such person. As of March 12, 2026, the registrant had 29,154,431 shares of common stock outstanding. TABLE OF CONTENTS PART IITEM 1.Business1ITEM 1A.Risk Factors13ITEM 1B.Unresolved Staff Comments30ITEM 1C.Cybersecurity30ITEM 2.Properties31ITEM 3.Legal Proceedings31ITEM 4.Mine Safety Disclosures31 ITEM 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities32ITEM 6.[Reserved]32ITEM 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations32ITEM 7A.Quantitative and Qualitative Disclosures about Market Risk43ITEM 8.Financial Statements and Supplementary Data43ITEM 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure43ITEM 9A.Controls and Procedures43ITEM 9B.Other Information43ITEM 9C.Disclosure Regarding Foreign J