Adial Pharmaceuticals Successfully Completes Manufacturing of Demonstration Batch Production, Enabling Clinical and Registration Production for AD04 Planned Phase 3 Trial

GLEN ALLEN, Va., April 22, 2026 — 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 successful completion of the demonstration batch production for AD04. The results of the batch confirmed that the transferred process met the targeted specifications for the planned Phase 3 clinical batch (and registration campaign) and matched the dissolution profile of the previous Phase 2 batch, thereby demonstrating a successful technical process transfer. This important step was required prior to manufacturing the batch production for the planned Phase 3 clinical program.

The successful tech transfer of the manufacturing and analytical capability for AD04 to a new CDMO resulted in significant efficiencies and crossing the hurdle of dissolution, blend and content uniformity which will have a meaningful clinical and commercial impact for AD04, once approved for patients suffering from AUD.

This successful achievement enables the production of the clinical and registration batches which are required to conduct the clinical trial as well as the needed data for updates to the IND for AD04 with the Food and Drug Administration (FDA).

Cary Claiborne, President and Chief Executive Officer of Adial, commented, “We are continuing to advance the AD04 program and are actively planning for the next phase of our clinical development efforts. The successful completion of the demonstration batch for AD04 positions Adial to effectively progress our plans for the planned clinical trial program, and will assist us with our ongoing discussions with the FDA.”

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. Adial is currently planning to conduct a new Phase 3 clinical trial program for the treatment of AUD in subjects with certain target genotypes identified using the Company’s proprietary diagnostic genetic test. ONWARD showed promising results in reducing drinking in heavy drinking patients, with 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.