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Adial Pharmaceuticals Awarded Notice of Allowance for Key Patent Combining Use of the Company’s Proprietary Genetic Diagnostic with AD04 to Treat Alcohol and Drug Dependence

Allowed claims cover the detection of select genotypes for use of AD04 to treating AUD and OUD patients

CHARLOTTESVILLE, Va., Oct. 19, 2023 — 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 announces it has been awarded a key patent combining the use of the Company’s proprietary genetic diagnostic to detect select genotypes for genetically target treatment of alcohol use disorder (AUD) and opioid use disorder (OUD) with the Company’s lead investigational new drug product AD04.

“This patent marks another important milestone in our pursuit to provide tailored, more effective treatments for individuals grappling with AUD and OUD,” stated Cary Claiborne, CEO of Adial Pharmaceuticals. “By combining our novel genetic diagnostic with AD04, a potentially transformative therapy for those battling AUD and OUD, we aim to optimize therapeutic outcomes, ensuring that patients receive the most suitable treatment for their unique genetic profile.”

The recently awarded patent further enhances Adial Pharmaceuticals’ position at the forefront of personalized medicine in addiction therapy. Recognizing that every patient’s genetic makeup is different, the proprietary diagnostic tool is designed to predict which patients are most likely to benefit from AD04 treatment.

“This patent is a further testament to our commitment to harnessing cutting-edge science for the betterment of countless lives affected by addiction. By understanding the genetic factors that play a role in addiction, we believe we can pave the way for treatments that are more effective and have fewer side effects,” concluded Mr. Claiborne.

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 (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 providing tailored, more effective treatments for individuals grappling with AUD and OUD, the potential of AD04 as a therapy for those battling AUD and OUD, combining Adial’s novel genetic diagnostic with AD04 to optimize therapeutic outcomes and ensure that patients receive the most suitable treatment for their unique genetic profile, the proprietary diagnostic tool being able to predict which patients are most likely to benefit from AD04 treatment 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 execute on our business strategy and bring AD04 to large markets in the most cost-effective and timely manner, 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 retain our key employees or maintain our Nasdaq listing, 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 and the continued maintenance and growth of our patent estate. 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


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