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GLEN ALLEN, Va. - Adial Pharmaceuticals, Inc. (NASDAQ:ADIL), a micro-cap pharmaceutical company with a market capitalization of $5 million, announced on Wednesday it has filed an update to its provisional patent application for AD04, the company’s investigational treatment for Alcohol Use Disorder (AUD). According to InvestingPro data, the company maintains a healthy balance sheet with more cash than debt, though it currently operates at a loss.
The updated patent application, which follows an initial filing in July 2024, is expected to extend protection for the company’s core assets until at least 2045, according to a press release statement.
AD04 is described as a genetically targeted, serotonin-3 receptor antagonist therapeutic agent intended for treating AUD in heavy drinking patients, defined as those consuming fewer than 10 drinks per drinking day.
The company reported that the patent application resulted from an "extensive examination of data and information" following the hiring of new patent counsel to strengthen Adial’s intellectual property portfolio.
Adial is preparing for an End-of-Phase 2 meeting with the U.S. Food and Drug Administration scheduled for July 29. The company previously conducted a Phase 3 clinical trial called ONWARD, which it stated showed "promising results in reducing drinking in heavy drinking patients" with "no overt safety or tolerability concerns."
The biopharmaceutical company also believes AD04 may have potential applications for treating other conditions including Opioid Use Disorder, gambling addiction, and obesity.
Adial Pharmaceuticals focuses on developing therapies for addiction and related disorders. The company uses a companion diagnostic genetic test to identify patients with specific target genotypes who may respond to its treatment.
In other recent news, Adial Pharmaceuticals has made significant strides in its development efforts for AD04, an investigational treatment for Alcohol Use Disorder. The company secured manufacturing agreements with Thermo Fisher Scientific and Cambrex to produce AD04 tablets for upcoming clinical trials and a planned New Drug Application submission to the FDA. Additionally, Adial has priced a public offering of 11,100,000 shares of common stock and accompanying warrants, expected to generate approximately $3.6 million in gross proceeds, with A.G.P./Alliance Global Partners serving as the sole placement agent.
The company has also advanced the design of its Phase 3 trial for AD04, collaborating with Cytel Inc. to refine the trial strategy and target specific genetic subpopulations. This refined approach aims to optimize trial design through advanced statistical analytics and simulation modeling. Furthermore, Adial has announced changes to its 2025 Annual Meeting of Stockholders, now scheduled for August 1, 2025, with new deadlines for shareholder proposals and proxy solicitations. These developments reflect Adial’s ongoing efforts to advance its clinical programs and engage with its shareholders effectively.
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