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

Adial Pharmaceuticals, a clinical-stage biopharmaceutical company focused on developing therapies for addiction and related disorders, has released its financial results for the third quarter of 2025. The company is making significant strides towards the FDA approval and commercialization of its lead investigational drug, AD04, aimed at treating Alcohol Use Disorder (AUD).

Financial Highlights

For the third quarter of 2025, Adial Pharmaceuticals reported a decrease in cash and cash equivalents to $4.6 million as of September 30, 2025, from $5.9 million as of June 30, 2025. The company anticipates that its current cash reserves will support operations into the second quarter of 2026. Research and development expenses saw a significant reduction of approximately $511 thousand (50%) compared to the same period in 2024, primarily due to lower clinical activity. General and administrative expenses increased by about $63 thousand (5%), attributed to the timing of the annual meeting. The net loss for the quarter was $1.8 million, an improvement from the $2.2 million net loss in the third quarter of 2024, driven by reduced R&D spending.

Business and Operational Highlights

Adial Pharmaceuticals has achieved several key milestones, including a successful End of Phase 2 (EOP2) meeting with the FDA, which provided guidance on the planned adaptive Phase 3 study design for AD04. The company is now implementing these recommendations to advance towards registrational Phase 3 development. The AD04 program targets patients who are biomarker-positive for AG+, a subset of the AUD population identified through Adial's proprietary genetic test.

Additionally, the company has partnered with Genomind to develop a precision medicine testing solution, completing the analytical validation of a cheek swab collection method to identify eligible patients. This method has been confirmed by the FDA as a Non-Significant Risk (NSR), meaning an Investigational Device Exemption (IDE) application is not required.

Strategic Initiatives and Corporate Developments

Adial Pharmaceuticals announced the filing of an update to the provisional patent application for AD04, which is expected to protect the company's core assets until at least 2045. This development is crucial for securing the intellectual property surrounding their lead investigational drug.

Management's Perspective

Cary Claiborne, CEO of Adial Pharmaceuticals, expressed confidence in the company's progress towards FDA approval and commercialization of AD04. He highlighted the successful EOP2 meeting with the FDA and the implementation of their recommendations as pivotal steps. Claiborne also noted the supportive stance of the U.S. Senate on expanding clinical trial endpoints, which aligns with Adial's therapeutic approach focused on reducing alcohol consumption and cravings.

Future Outlook

Looking ahead, Adial Pharmaceuticals is preparing for its Phase 3 program and expects to accelerate strategic partnership discussions as it continues to reach key milestones. The company remains committed to disciplined execution and believes that AD04 has the potential to become the first genetically targeted therapy approved for AUD, addressing a significant unmet medical need with substantial commercial opportunity.

Original SEC Filing: ADIAL PHARMACEUTICALS, INC. [ ADIL ] - 8-K - Nov. 14, 2025