From GlobeNewswire: 2025-03-04 08:30:00

Adial Pharmaceuticals, Inc. reported successful completion of a key pharmacokinetics study for AD04, confirming bioavailability and safety. FDA approval was granted for a bridging strategy to progress AD04 into Phase 3 trials. The company secured new patents for genetic-based treatments of Alcohol Use Disorder and opioid-related disorders.

Cary Claiborne, CEO, highlighted significant milestones achieved in 2024, including positive FDA feedback and initiation of clinical supply manufacturing for Phase 3 trials in 2025. Adial also strengthened its regulatory strategy by partnering with Boudicca Dx for companion diagnostic genetic testing. Phase 3 trials are set to begin this year to address addiction treatment needs.

Adial Pharmaceuticals appointed Vinay Shah as Chief Financial Officer, bringing over 25 years of experience in the pharmaceutical industry. Recent patents issued by the USPTO focus on identifying genetic markers for alcohol and opioid-related disorders, enhancing AD04 treatment methods. The company commended the NIAAA for a broader recovery definition aligning with AD04’s potential impact on patients.

Financially, Adial reported cash and cash equivalents of $3.8 million as of December 31, 2024. Research and development expenses increased by 155%, driven by clinical trial costs. Net Loss was $13.2 million for 2024, primarily due to non-cash charges. The company believes its current funds will support operations into the second half of 2025.

Adial Pharmaceuticals is a biopharmaceutical company focusing on addiction treatment, with AD04 as its lead investigational drug. AD04 showed promising results in reducing heavy drinking in patients with specific genotypes during Phase 3 trials. The company aims to offer treatment options for addiction beyond Alcohol Use Disorder.



Read more at GlobeNewswire:: Adial Pharmaceuticals Reports 2024 Fiscal Year Financial