Adial Pharmaceuticals Inc 2024年度报告

to Shareholders Adial Pharmaceuticals, Inc. UNITED STATES SECURITIES AND EXCHANGE COMMISSIONWASHINGTON, DC 20549 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, 2024 or Commission file number:001-38323 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 Securities Exchange Act of 1934during 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 filingrequirements for the past 90 days. Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 ofRegulation S-T (section 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submitsuch 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 anemerging growth company. See the definitions of “large accelerated filer, “accelerated filer” “smaller reporting company” and “emerging growthcompany” 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 with any newor 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 its internalcontrol over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm thatprepared 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 included in thefiling 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☐No☒ The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant, based on the closing price of a share ofthe registrant’s common stock on June 30, 2024 (the last business day of the registrant’s mostly recently completed second fiscal quarter) as reported bythe Nasdaq Capital Market on such date was $4,832,073. This calculation does not reflect a determination that certain persons are affiliates of theregistrant for any other purpose. As of February 28, 2025, the issuer had 6,574,588 shares of common stock outstanding. Documents incorporated by reference:None TABLE OF CONTENTS PagePART I1Item 1.Business1Item 1A.Risk Factors25Item 1B.Unresolved Staff Comments59Item 1C.Cybersecurity59Item 2.Properties60Item 3.Legal Proceedings60Item 4.Mine Safety Disclosures60PART II61Item 5.Market for Registrant’s Common Equity Related Stockholder Matters and Issuer Purchases of Equity Securities61Item 6.[Reserved]63Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations64Item 7A.Quantitative and Qualitative Disclosures About Market Risk72Item 8.Financial Statements and Supplementary DataF-1Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure73Item 9A.Controls and Procedures73Item 9B.Other Information74Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections74PART III75Item 10.Directors, Executive Officers and Corporate Governance75Item 11.Executive Compensation81Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters89Item 13.Certain Relationships and Related Transactions, and Director Independence91Item 14.Principal Accountant Fees and Services95PART IV96Item 15.Exhibit and Financial Statement Schedules96Item 16.Form 10-K Summary96SIGNATURES101 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 Act of 1933, as amended(the “Securities Act”), and Sect