Adial Pharmaceuticals Awarded New Patent Notice of Allowance from the United States Patent and Trademark Office

Expands patent estate covering Adial’s unique molecular genetic approach to diagnosing and potentially treating alcohol and drug dependence

CHARLOTTESVILLE, Va., Feb. 13, 2024 (GLOBE NEWSWIRE) — Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced it has been awarded an important patent which expands the estate covering the combination of the Company’s proprietary genetic diagnostic to identify patients with specific genotypes for genetically targeted treatment of alcohol use disorder (AUD) and drug dependencies, such as opioid use disorder (OUD), with the Company’s lead investigational new drug product AD04.

“Following a post hoc analysis of our ONWARD™ Phase 3 results, we identified patients with specific genotypes that responded extremely well to AD04. Given the positive results, we believe the combination of our genetic diagnostic and AD04 can provide a tailored treatment solution for those who suffer from AUD and OUD,” commented Cary Claiborne, CEO of Adial Pharmaceuticals. “This key patent significantly expands the scope of our intellectual property (IP) protection in the United States to cover important aspects of our unique molecular approach to diagnosing and potentially treating AUD and other drug dependencies such as OUD. By combining a tool to predict which patients are most likely to benefit from AD04 treatment, with AD04’s clinical track record of reducing heavy drinking days among patients with specific genotypes, we believe we can transform the lives of millions affected by AUD and other dependencies. Among patients with the target genotypes, we believe the addressable market for AD04 is approximately $40 billion, in the U.S. alone. We remain committed to further understanding the genetic factors that affect addiction and bringing a personalized approach to addiction with AD04.”

About Adial Pharmaceuticals, Inc.

Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of therapies for the treatment and prevention of addiction and related disorders. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of AUD in heavy drinking patients and was recently investigated in the Company’s ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes (estimated to be approximately one-third of the AUD population) identified using the Company’s proprietary companion diagnostic genetic test. ONWARD showed promising results in reducing heavy drinking in heavy drinking patients, and no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. Additional information is available at www.adial.com.

Forward Looking Statements

This communication contains certain “forward-looking statements” within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding the combination of the Company’s genetic diagnostic and AD04 providing a tailored treatment solution for those who suffer from AUD and OUD, transforming the lives of millions affected by AUD and other dependencies by the Company combining a tool to predict which patients are most likely to benefit from AD04 treatment with AD04’s clinical track record of reducing heavy drinking days among patients with specific genotypes, the addressable market for AD04 being approximately $40 billion among patients with the target genotypes in the U.S. alone, bringing a personalized approach to addiction with AD04 and the potential of AD04 to treat other addictive disorders such as opioid use disorder, gambling, and obesity. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, our ability to develop strategic partnership opportunities and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund our research and development activities, our ability to complete clinical trials on time and achieve desired results and benefits as expected, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of our product candidates in the marketplace and the successful development, marketing or sale of our products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our Annual Report on Form 10-K for the year ended December 31, 2022, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.

Contact:
Crescendo Communications, LLC
David Waldman / Alexandra Schilt
Tel: 212-671-1020
Email: ADIL@crescendo-ir.com