Adial Pharmaceuticals Announces Publication in Leading Peer-Reviewed Journal Supporting the Potential Efficacy of AD04 as a Precision Medicine for the Treatment of Alcohol Use Disorder

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, announced the publication of previously disclosed results from its Phase 3 ONWARD study in a peer-reviewed article in the European Journal of Internal Medicine entitled, “Low-dose ondansetron: A candidate prospective precision medicine to treat alcohol use disorder endophenotypes.” The publication findings showed a significant difference in the monthly percentage of heavy drinking days between the Company’s lead asset, AD04 (low-dose ondansetron), and the placebo group among heavy drinking patients with Alcohol Use Disorder (AUD) and specific genotypic variants.

Key findings include:

• AD04 significantly decreased the monthly percentage of heavy drinking days after 6 months of treatment among heavy drinking individuals with alcohol use disorder and a specific genetic profile, as determined via a CDx
• This genotypic profile is in the serotonin transporter and serotonin-AB receptor complex
• AD04′s adverse events (AEs) match those of the placebo
• Combining AD04 with psychosocial intervention may change favorably how AUD disease is perceived and increase the demand for treatment to many who not have otherwise considered it

“The findings highlighted in the publication underscore the promise of AD04, with incorporation of a CDx, as an important advancement in the field of precision medicine. This approach is critical as AUD can be caused by a variety of gene-environment interactions and does not manifest uniformly across all patients,” said Cary Claiborne, CEO of Adial. “We believe patients struggling with AUD stand to gain greater benefit from precision treatments to reduce alcohol consumption such as AD04, as opposed to a one size fits all approach. Recognizing the benefits of AD04 within this genetically and behaviorally defined patient population will allow Adial to continue developing a 21st-century-based approach to the treatment of this devastating disorder. AD04 offers a novel strategy to manage AUD by reducing the potential harm of AUD, while lowering the perceived stigma of personal failure associated with the disorder.”

The study examined the role of endophenotypes in predicting AD04’s efficacy for the treatment of AUD and found that specific genotypes affecting the serotonin transporter and serotonin-AB receptor complex are predictive of AD04’s ability to reduce the number of heavy drinking days among patients with AUD. In particular, the data revealed that individuals with specific genetic backgrounds and meeting the criteria to be defined as “heavy drinkers” (avg. <10 drinks per drinking day) saw a reduction in the monthly percentage of heavy drinking days after 6 months of treatment. Additional analysis revealed that patients treated with AD04 experienced minimal AEs which were comparable to placebo treatment, high medication compliance, and a minimal dropout rate. The authors further noted that there is no existing study in alcohol literature where an effective medication exhibits a similar AE profile to a placebo.

About Adial Pharmaceuticals, Inc.Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions 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 companion diagnostic genetic test. ONWARD showed promising results in reducing 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 potential use of AD04 as a precision medicine for the treatment of AUD, combining AD04 with psychosocial intervention changing favorably how AUD disease is perceived and increasing the demand for treatment to many who not have otherwise considered it, patients struggling with AUD standing to gain greater benefit from precision treatments to reduce alcohol consumption such as AD04, as opposed to a one size fits all approach, recognizing the benefits of AD04 within this genetically and behaviorally defined patient population allowing Adial to continue developing a 21st-century-based approach to the treatment of this devastating disorder, AD04 offering a novel strategy to manage AUD by reducing the potential harm of AUD while lowering the perceived stigma of personal failure associated with the disorder 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: [phone]                                Email: [e-mail]