Adial Pharmaceuticals expects cash to fund operations into 2H of 2025

Cash and cash equivalents were $3.8 million as of December 31, 2024, compared to $2.8 million as of December 31, 2023. The Company believes that its existing cash and cash equivalents will fund its operating expenses into the second half of 2025 based on currently committed development plans. “We achieved meaningful milestones in 2024, leading to positive feedback from the U.S. Food and Drug Administration regarding our proposed 505(b)(2) bridging strategy and the initiation of clinical supply manufacturing for our upcoming Phase 3 trial this year,” said Cary Claiborne, CEO of Adial Pharmaceuticals (ADIL). “A key achievement was the completion of our pharmacokinetics study evaluating AD04, our investigational drug for the treatment of Alcohol Use Disorder. This study assessed the PK profile, bioavailability, and food effect of AD04 near-micro doses compared to marketed Ondansetron in healthy volunteers. The findings enabled the FDA to confirm the bridging requirements for our 505(b)(2) registration pathway and support our planned micro-dosing regimen for the upcoming registrational trials.”