Press Release

New Patent covers claims which focus on method for identifying genetic markers in patients with alcohol or opioid related disorders

Patent expands the identification of potential treatment candidates for AD04 administration based on the patient’s unique genetic profile

GLEN ALLEN, Va., Feb. 19, 2025 — Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“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 patent number 12,226,401 was issued on February 18, 2025 by the United States Patent and Trademark Office (USPTO) expanding coverage of Adial’s genetic-based approach to treating and diagnosing alcohol use disorder and other drug dependencies.

The new patent covers claims that focus on a method for identifying genetic markers in patients with alcohol or opioid-related disorders. With the identification of specific genotypes, including the AC genotype of rs17614942 in the HTR3B gene and the AG genotype of rs1150226 in the HTR3A gene, providers will be able to provide tailored treatment plans using AD04, the Company’s investigational new drug product. This patent also expands the identification of possible treatment candidates for AD04 administration depending on the patient’s unique genetic profile. By aligning therapeutic approaches with genetic data, the AD04 precision medicine approach is designed to deliver optimal outcomes while reducing risks associated with one-size-fits-all approaches.

“This patent demonstrates our continued dedication to advancing science-driven solutions for diagnosing and treating addiction,” said Cary Claiborne, CEO of Adial Pharmaceuticals. “Our patented approach, which uses genetic information to guide treatment, has the potential to transform how alcohol and opioid dependence are treated. We believe this personalized method not only enhances effectiveness but also provides new options to millions suffering from addiction by addressing the root causes on a molecular level.”

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 Alcohol Use Disorder (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 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.

If you are interested in exploring partnership opportunities with Adial, we invite you to reach out to us (BD@adialpharma.com) to discuss how our joint efforts can bring about positive change to the millions of patients who are struggling with addiction.

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 providers being able to provide tailored treatment plans using AD04 with the identification of specific genotypes, including the AC genotype of rs17614942 in the HTR3B gene and the AG genotype of rs1150226 in the HTR3A gene, delivering optimal outcomes while reducing risks associated with one-size-fits-all approaches by aligning therapeutic approaches with genetic data, advancing science-driven solutions for diagnosing and treating addiction, the Company’s patented approach having the potential to transform how alcohol and opioid dependence are treated, the Company’s personalized method not only enhancing effectiveness but also providing new options to millions suffering from addiction by addressing the root causes on a molecular level 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 pursue our regulatory strategy, our ability to advance ongoing partnering discussions, 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, 2023, 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