Adial Pharmaceuticals Reports Second Quarter 2025 Financial Results and Provides Business Update

Core Insights - Adial Pharmaceuticals is at a pivotal moment following a successful End of Phase 2 meeting with the FDA, which provided essential feedback for the upcoming Phase 3 trial of its lead drug AD04 for Alcohol Use Disorder (AUD) [2] - The company has established manufacturing agreements with Thermo Fisher Scientific and Cambrex to ensure a reliable supply chain for drug production [2] - Adial has regained compliance with Nasdaq Listing Rule 5550(b)(1), maintaining stockholders' equity above $2.5 million [3] Business Developments - The FDA meeting confirmed key protocol elements for the Phase 3 trial, including patient population and endpoints, aimed at increasing the likelihood of success [2] - Collaboration with Cytel has enabled the identification of genetically defined subgroups that may benefit from AD04, allowing for a targeted Phase 3 program [2] - Strategic partnership discussions are expected to accelerate following the FDA milestone [2] Intellectual Property - An update to the provisional patent application for AD04 was filed, which is anticipated to protect the company's core assets until at least 2045 [4] Financing - A public offering was announced on June 17, 2025, for 11,100,000 shares at a price of $0.3251 per share, expected to generate approximately $3.0 million for working capital and corporate purposes [5] Financial Results - As of June 30, 2025, cash and cash equivalents were $5.9 million, an increase from $2.4 million as of March 31, 2025, which is projected to fund operations into the second quarter of 2026 [10] - Research and development expenses decreased by approximately $281 thousand (28%) year-over-year, attributed to lower contract labor and clinical activity [10] - General and administrative expenses also saw a decrease of about $125 thousand (10%) due to reduced equity compensation and legal costs [10] - The net loss for the second quarter of 2025 was $2.0 million, down from $2.5 million in the same period of 2024, primarily due to lower spending [10]