UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, 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 ended December 31, 2022 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: 001-38323 ADIAL PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 82-3074668 (State or Other Jurisdiction of (I.R ...

Financial Reporting and Compliance - The company has identified material weaknesses in its internal control over financial reporting, which may lead to material misstatements in financial statements [240]. - The company is subject to increasing legal, accounting, and financial compliance costs due to the reporting requirements of the Sarbanes-Oxley Act [238]. - The company anticipates incurring significant legal, accounting, and compliance costs as a public entity, which were not present as a private company [399]. - The company is classified as an "emerging growth company" and will remain so until total annual gross revenue exceeds $1.07 billion or other specified conditions are met [397]. Clinical Trials and Product Development - The company is currently conducting the ONWARD Phase 3 clinical trial for its lead product candidate, AD04, with approximately 290 patients in Scandinavia and Central and Eastern Europe [248]. - The company anticipates completing patient enrollment in the ONWARD pivotal Phase 3 clinical trial in Q2 or Q3 of 2021, but patient enrollment challenges may lead to significant delays [286]. - The company plans to test AD04 in adolescent patients (ages 12-17) as part of the next Phase 3 trial [272]. - The company has limited experience in conducting clinical trials, which may impact the timely completion of planned trials [279]. - The company cannot guarantee that the clinical trial material produced will be approved for use in trials, which could delay the clinical program [274]. - Success in preclinical testing and early clinical trials does not ensure later clinical trials will be successful, which could delay commercialization [281]. - The company must demonstrate safety and efficacy through lengthy and expensive preclinical testing and clinical trials before obtaining regulatory approvals for AD04 and future product candidates [283]. - The FDA may require additional clinical trials for patients negative for the targeted genotypes, potentially delaying approval [270]. - The approval of AD04 is contingent upon the successful development and approval of a companion diagnostic genetic test [275]. - The Phase 3 trials are expected to last 24 weeks, compared to the 12 weeks of the Phase 2b trial [268]. - The FDA has indicated that a satisfactory endpoint for the Phase 3 trial will be the percentage of patients with no heavy drinking days in the last two months of a six-month treatment regimen [269]. Market and Competitive Landscape - The pharmaceutical industry is characterized by rapid technological change and substantial competition, which may impair the company's business [289]. - The company will compete against larger pharmaceutical companies and smaller firms with greater resources and experience in drug development and commercialization [291]. - The success of the product candidates will depend on acceptance by physicians, healthcare payers, and patients, particularly as the products are intended to be used in conjunction with genetic testing [288]. - Market acceptance of AD04 and future product candidates is uncertain, and failure to gain acceptance could significantly harm revenue generation [319]. Financial Risks and Funding - The company currently generates no revenues from its product candidate and may never be able to develop or commercialize a marketable drug [251]. - The company may need to raise additional financing through equity sales, which could have a dilutive effect on existing shareholders [237]. - The company may require additional financing in the future, which could lead to dilution of existing shareholders' equity [408]. - If the common stock is de-listed and trades as a "penny stock," it may face additional regulatory requirements that could limit trading activity and increase transaction costs [410]. - The company may incur substantial costs if its products infringe on the proprietary rights of other parties, which could include obtaining licenses, redesigning products, or paying damages [349]. Intellectual Property and Legal Risks - There is a risk of third parties asserting claims related to their intellectual property rights, which could lead to costly litigation and diversion of resources [348]. - The company has limited protection for its intellectual property, and unauthorized use of technology may occur despite licensing efforts [340]. - The company cannot assure that pending patent applications will be approved or that issued patents will provide significant commercial protection [343]. - Non-compliance with patent application requirements could lead to abandonment or loss of patent rights, allowing competitors to enter the market [356]. - The company may face lawsuits to protect or enforce patents, which could be expensive and time-consuming, with adverse outcomes risking the validity of licensed patents [351]. Strategic Partnerships and Acquisitions - The company may pursue acquisitions and joint ventures, but lacks experience in integrating such transactions successfully [377]. - The company relies on collaboration agreements for the commercialization of investigational product candidates, which may involve greater uncertainty and less control [335]. - If strategic partnerships are not established or maintained, the development of current and future product candidates may be delayed or terminated [332]. - The acquisition of Purnovate is expected to provide strategic benefits, but there is no assurance that these benefits will materialize or enhance stockholder value [292]. Stockholder and Governance Issues - The company has outstanding warrants to purchase 7,957,225 shares at a weighted average exercise price of $4.83, which could dilute common stock ownership [389]. - The company’s board is authorized to issue 50,000,000 shares of common stock and 5,000,000 shares of preferred stock, potentially diluting existing shareholders [390]. - The company has never paid dividends and does not plan to do so in the future, intending to retain future earnings for operations [392]. - Provisions in the corporate charter and Delaware law may complicate potential acquisitions, potentially hindering stockholder interests [411]. - The company's board of directors is divided into three classes, with each class serving a three-year term, which may limit stockholder influence on management [412].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 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: 001-38323 ADIAL PHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in its Charter) | --- | --- | |------ ...