Adial Pharmaceuticals Reports First Quarter 2023 Financial Results and Provides Business Update

Conducted meetings with U.S. and select European regulatory agencies

Received Notice of Exercise and upfront cash of $0.45 million from Advocate for the sale of Purnovate assets and business

Ended 2023 first quarter with cash and cash equivalents of $2.3 million

CHARLOTTESVILLE, Va., May 12, 2023 (GLOBE NEWSWIRE) -- 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 provided a business update and reported its financial results for the first quarter of 2023.

Cary Claiborne, President and Chief Executive Officer of Adial, stated, “We continue to pursue our highly focused regulatory strategy and have conducted meetings with the U.S. Food and Drug Administration (FDA), the Swedish Medical Product Agency, the Federal Institute for Drugs and Medical Devices (BfArM) in Germany and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom. We are currently waiting on final meeting minutes from the respective agencies, which receipt varies depending on the country. As we previously expressed, we remain highly confident in our regulatory strategy as we believe these meetings, and the resulting minutes, will provide us with a clearer understanding of the best path forward to approval. Armed with this information, we will be in a much stronger position to advance ongoing partnering discussions. Assisting us in our partnering efforts, we have engaged The Keswick Group. Given their extensive experience and successful track record of identifying, evaluating, and progressing strategic collaborations, we believe we are well positioned to execute on our business strategy and bring AD04 to large markets in the most cost-effective and timely manner.”

“Furthermore, as previously announced, we received an irrevocable notice of exercise on May 8, 2023 from Adovate to acquire the assets and business of our Purnovate subsidiary effective May 16, 2023, which allows us to exclusively focus on advancing AD04 through potential regulatory approval and prioritize our resources accordingly. Additionally, the sale of Purnovate assets provides us with non-dilutive upfront capital while maintaining meaningful equity and downstream economics, including potential development and commercial milestone payments of up to $83 million on the first three compounds. We believe this strategy maximizes the value of both AD04 and Purnovate assets. Overall, we have made significant progress and continue to execute our business strategy and we look forward to providing additional updates in the near-term, including feedback received from the respective regulatory agencies.”