Hepion Pharmaceuticals Inc 2025年度报告

FORM 10-K ☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the year endedDecember 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 001-36856 HEPION PHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in Its Charter) Delaware46-2783806(State or other jurisdiction ofincorporation or organization)(I.R.S. EmployerIdentification Number) 55 Madison Ave, Suite 400- PMB# 4362, Morristown, New Jersey 07960(Address of Principal Executive Offices) Registrant’s telephone number, including area code:(732) 902-4000 Securities registered pursuant to Section 12(b) of the Act: Name of each exchange on which registeredOTC QB HEPA 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 Section 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 SecuritiesExchange Act of 1934 during the preceding 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 90 days. Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submittedpursuant to Rule 405 of Regulation S-T (? 232.405 of this chapter) during the preceding 12 months (or for such shorter period that theregistrant was required to submit such files). Yes☒No☐ Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and willnot be contained, to the best of the registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.☒ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smallerreporting company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerginggrowth company” in Rule 12b-2 of the Exchange Act.: Large accelerated filer☐Accelerated filer☐Non-accelerated filer☒Smaller reportingcompany☒Emerging growthcompany☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period forcomplying 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 Exchange Act). Yes☐No☒ As of June 30, 2025, the aggregate market value of the registrant’s voting stock held by non-affiliates was approximately $0.9million based on the last reported sale price of the registrant’s common stock. The number of shares of the registrant’s Common Stock outstanding as of March 11, 2026 was 11,620,317. Documents Incorporated by Reference: Parts of the registrant’s Proxy Statement for the Registrant’s 2026 Annual Meeting of Stockholders are incorporated by reference intoPart III of this Annual Report on Form 10-K. Such Proxy Statement will be filed with the Securities and Exchange Commission within120 days of the registrant’s fiscal year ended December 31, 2025. TABLE OF CONTENTS PART I Item 1.Business5Item 1A.Risk Factors12Item 1B.Unresolved Staff Comments43Item 1C.Cybersecurity43Item 2.Properties44Item 3.Legal Proceedings44Item 4.Mine Safety Disclosures44 Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities45Item 6.[Reserved]45Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations45Item 7A.Quantitative and Qualitative Disclosures About Market Risk50Item 8.Financial Statements and Su