Adial 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 fiscal year endedDecember 31, 2025 or For the transition period fromto Commission file number:001-38323 ADIAL PHARMACEUTICALS, INC.(Exact name of registrant as specified in its charter) Securities registered pursuant to Section 12(b) of the Act: 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 issuer: (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 (section 232.405 of this chapter) during the preceding 12 months (or for such shorter periodthat 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☒ 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 the effectivenessof its internal control over financial reporting under Section404(b)of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registeredpublic 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- basedcompensation 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☒ The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant, based on the closingprice of a share of the registrant’s common stock on June 30, 2025 (the last business day of the registrant’s mostly recently completedsecond fiscal quarter) as reported by the Nasdaq Capital Market on such date was $6,483,200. This calculation does not reflect adetermination that certain persons are affiliates of the registrant for any other purpose. As of March 4, 2026, the issuer had 1,427,970 shares of common stock outstanding. Documents incorporated by reference:None FORM 10-K TABLE OF CONTENTS PagePART I1Item 1.Business1Item 1A.Risk Factors22Item 1B.Unresolved Staff Comments56Item 1C.Cybersecurity56Item 2.Properties57Item 3.Legal Proceedings57Item 4.Mine Safety Disclosures57PART II58Item 5.Market for Registrant’s Common Equity Related Stockholder Matters and Issuer Purchases of Equity Securities58Item 6.[Reserved]60Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations61Item 7A.Quantitative and Qualitative Disclosures About Market Risk68Item 8.Financial Statements and Supplementary DataF-1Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure69Item 9A.Controls and Procedures69Item 9B.Other Information69Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections69PART III70Item 10.Directors, Executive Officers and Corporate Governance70Item 11.Executive Compensation76Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters84Item 13.Certain Relationships and Related Transactions, and Director Independence86Item 14.Principal Accountant Fees and Services88PART IV89Item 15.Exhibit and Financial Statement Schedules89Item 16.Form 10-K Summary89SIGNATURES94 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains “forward-looking statements” within the meaning of Section 27A of the Securities Ac