Adial signs manufacturing deals for alcohol disorder drug trials

GLEN ALLEN, Va. - Adial Pharmaceuticals, Inc. (NASDAQ:ADIL), a micro-cap pharmaceutical company with a market capitalization of $3.62 million, has secured manufacturing agreements with Thermo Fisher Scientific and Cambrex to produce its investigational alcohol use disorder treatment AD04, the company announced Wednesday. According to InvestingPro data, the company maintains a healthy balance sheet with more cash than debt, despite challenging market conditions.

The agreements cover production of AD04 (0.33 mg ondansetron tablets) for upcoming clinical trials and the planned New Drug Application submission to the U.S. Food and Drug Administration. Demonstration batches required before registration and clinical batches have already been completed. With its current ratio of 1.99, InvestingPro analysis suggests the company has adequate liquidity to support its near-term operational needs.

Thermo Fisher will serve as the Contract Development and Manufacturing Organization for the drug product, while Cambrex will supply the ondansetron active pharmaceutical ingredient under an FDA-approved Drug Master File.

"These agreements with Thermo Fisher and Cambrex are another key component in our planning for the upcoming conduct of the AD04 clinical trial program and to meet our requirements for the FDA," said Cary Claiborne, President and CEO of Adial Pharmaceuticals.

The collaboration includes manufacturing for clinical supplies and preparation of Chemistry, Manufacturing, and Controls documentation required for FDA submission.

AD04 is Adial’s genetically targeted, serotonin-3 receptor antagonist being developed for Alcohol Use Disorder in heavy drinking patients. The company recently completed its ONWARD pivotal Phase 3 clinical trial, which showed promising results in reducing drinking with no overt safety concerns. However, investors should note that InvestingPro analysis indicates the stock has experienced significant volatility, trading near its 52-week low of $0.22, with analysts not anticipating profitability this year. InvestingPro subscribers have access to 10+ additional insights about ADIL’s financial health and market performance.

The information in this article is based on a company press release statement.

In other recent news, Adial Pharmaceuticals has priced a public offering of 11.1 million shares of common stock and accompanying warrants, aiming to raise approximately $3.6 million in gross proceeds. The offering includes Series D and Series E warrants, with exercise prices set at $0.35 per share. The company plans to use the net proceeds for working capital and general corporate purposes. Additionally, Adial Pharmaceuticals announced a change in the date for its 2025 Annual Meeting of Stockholders, now scheduled for August 1, 2025. The company has also made advancements in designing its Phase 3 trial for AD04, its investigational treatment for Alcohol Use Disorder, by partnering with Cytel Inc. to refine the trial design. In related developments, Adial secured a meeting with the FDA to discuss the Phase 3 trial plan for AD04, which has shown promise in previous evaluations. The meeting is scheduled for July 25, 2025, and will focus on clinical development plans and protocol designs. Lastly, Adial has revised the deadline for shareholder proposals for its upcoming annual meeting, with new deadlines set for May 25, 2025.

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