Press Release

GLEN ALLEN, Va., Oct. 15, 2024 — 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 applauded the National Institute on Alcohol Abuse and Alcoholism (NIAAA) for its newly updated definition of recovery. The new definition, outlined and emphasized in NIAAA’s 2025 Professional Judgement Budget (PJB) as reported to the U.S. Congress following an original introduction in an NIAAA PJB, emphasizes a broader, non-abstinence approach to recovery, which aligns directly with Adial’s AD04 program, which has the potential to offer patients the flexibility of reducing drinking and/or abstinence.

NIAAA’s updated definition underscores a growing clinical outcome goal and recognition that effective recovery solutions need not be solely abstinence based, opening the door to therapeutic options that focus on harm reduction and improved quality of life. AD04, Adial’s lead investigational product for alcohol use disorder (AUD), is designed to support patients seeking flexible treatment that could offer reduction in drinking and/or abstinence recovery paths, making it a promising candidate to meet the evolving market needs. This recognition and further emphasis in the FY 2025 Professional Judgement Budget by NIAAA is validation of Adial’s approach as meeting the NIAAA’s new standard for recovery, broadening Adial’s significant commercial and government market potential.

“AD04 is uniquely positioned to provide a therapeutic option for those seeking a reduction in alcohol use and/or complete abstinence,” said Cary Claiborne, CEO of Adial Pharmaceuticals. “With NIAAA’s focus shifting to include non-abstinence recovery approaches, we are optimistic that this will stimulate additional support for programs like AD04, not only within commercial markets but also from government initiatives. The alignment of AD04’s development and the NIAAA’s updated perspective offers a promising future for those suffering from AUD, providing them with more personalized, flexible treatment options.”

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 in 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 AD04 supporting patients seeking flexible treatment that could offer reduction in drinking and/or abstinence recovery paths, making it a promising candidate to meet the evolving market needs, the recognition by NIAAA that effective recovery solutions need not be solely abstinence based broadening Adial’s significant commercial and government market potential, AD04 being uniquely positioned to provide a therapeutic option for those seeking a reduction in alcohol use and/or complete abstinence, NIAAA’s focus shifting to include non-abstinence recovery approaches stimulating additional support for programs like AD04, not only within commercial markets but also from government initiatives, the alignment of AD04’s development and the NIAAA’s updated perspective offering a promising future for those suffering from AUD, providing them with more personalized, flexible treatment options 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