Adial Pharmaceuticals Awarded Additional U.S. Patent Combining the Use of the Company's Proprietary Genetic Diagnostic With AD04 to Treat Alcohol and Drug Dependence

New patent covers the use of the full genetic panel measuring all five genetic biomarkers

CHARLOTTESVILLE, Va., — Adial Pharmaceuticals, Inc. (“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 11,351,154 was issued on June 7, 2022, by the U.S. Patent and Trademark Office. The patent covers the use of the Company’s genetic diagnostic panel in combination with the Company’s lead product, AD04, for the treatment of alcohol use disorder (AUD) and Opioid Use Disorder (OUD). This patent expands coverage of previously issued patents to include the measurement of the genetic biomarkers for all of the targeted genotypes utilizing the Company’s proprietary diagnostic test.

William Stilley, Adial’s Chief Executive Officer, stated, “This latest patent covering the use of AD04 as a potential treatment for AUD and OUD, combining all five distinct genetic biomarkers, is a critical component of our broader strategy to build a robust moat of patents around AD04. Importantly, AD04 represents a potential breakthrough in the treatment of addiction as a genetically targeted therapy. Moreover, the pharmaceutical industry, insurers and regulators are increasingly focusing on precision medicine as a means to improve patient outcomes, while effectively managing healthcare costs by directing resources towards those patients most likely to respond. As a result of this latest patent, we have expanded our IP portfolio to over 90 patents and patents pending covering the use of both AUD and OUD in over 40 jurisdictions around the world. As a result, we believe we have built a robust patent estate providing us market protection through 2031, plus expected extensions until 2036.

“An estimated 35 million people in the United States alone, are estimated to have AUD. In addition to the market opportunity for AD04 as a therapy, we believe the total potential market for our companion diagnostic genetic test as a stand-alone commercial business line could represent another potentially significant business line for the Company. At the same time, we have completed our ONWARD™ Phase 3 pivotal trial, and look forward to reporting the results in the coming weeks.”

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