GLEN ALLEN, Va., Aug. 14, 2025 (GLOBE NEWSWIRE) — 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, today provided a business update and reported its financial results for the second quarter of 2025.
Cary Claiborne, CEO of Adial Pharmaceuticals, commented, “We believe we are at an inflection point in Adial’s journey. With the successful completion of our End of Phase 2 meeting with the Food and Drug Administration (FDA), we have received critical input from the FDA on the clinical and statistical design of our upcoming Phase 3 trial for AD04, our lead investigational drug and a serotonin-3 receptor antagonist being developed for the treatment of Alcohol Use Disorder (AUD). This includes agreement on key protocol elements—such as patient population, endpoints, biomarker stratification, and adaptive enrichment strategies—all of which are designed to increase the likelihood of success and support a streamlined path to approval. We expect to receive the official meeting minutes from the FDA within 30 days of the meeting date.”
“Additionally, our collaboration with Cytel has been instrumental in shaping a precision-driven, data-informed strategy. By applying advanced machine learning tools and simulation modeling, we’ve identified genetically defined subgroups most likely to benefit from AD04. This enables us to pursue a highly targeted and efficient Phase 3 program, with the potential for interim analyses that could accelerate timelines and increase value creation for shareholders.”
“In parallel, we have secured U.S.-based manufacturing agreements with Thermo Fisher Scientific and Cambrex to ensure robust drug product and drug substance supply. These partnerships not only provide the clinical and commercial manufacturing capacity we need but also reduce supply chain risk and strengthen our Chemistry, Manufacturing, and Controls (CMC) position for future NDA submission. The demonstration batches are already complete, and we’re well positioned to initiate registration and validation batches in support of the clinical program.”
“We look forward to advancing the clinical program for AD04 and with our progress on the regulatory, clinical, and manufacturing fronts, we are optimistic about achieving a successful outcome in the Phase 3 program. These accomplishments are also catalyzing strategic partnership discussions, which we believe will accelerate now that we’ve met this critical FDA milestone. We remain committed to disciplined execution and believe AD04 has the potential to be the first genetically targeted therapy approved for AUD, a market with enormous unmet need and commercial potential.”
Other Developments
Nasdaq
On July 16, 2025, Adial announced that it received notice from Nasdaq on July 14, 2025 that the Company has regained compliance with Nasdaq Listing Rule 5550(b)(1), which requires listed companies to maintain stockholders’ equity of at least $2,500,000.
Intellectual Property
On July 9, 2025, Adial announced the filing of an update to the provisional patent application for AD04 which was filed in July 2024, the Company’s lead investigational genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment …