Adial Pharmaceuticals (NASDAQ: ADIL) reported Q2 2025 financial results and provided significant updates on its AD04 drug development program for Alcohol Use Disorder (AUD). The company successfully completed its End of Phase 2 FDA meeting, receiving crucial input for its upcoming Phase 3 trial design. Cash position strengthened to $5.9 million as of June 30, 2025, up from $2.4 million in Q1, supported by a $3.0 million public offering. Key developments include securing U.S. manufacturing partnerships with Thermo Fisher Scientific and Cambrex, regaining Nasdaq compliance, and filing an updated provisional patent expected to protect core assets until 2045. The company reported a reduced net loss of $2.0 million compared to $2.5 million in Q2 2024, with decreased R&D expenses by 28% and G&A expenses by 10%.

GLEN ALLEN, Va., Aug. 14, 2025 (GLOBE NEWSWIRE) — Adial Pharmaceuticals, Inc. (“Adial”) or the “Company”, a clinical‑stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today provided a business update and reported its financial results for the second quarter of 2025. Cary Claiborne, CEO of Adial Pharmaceuticals, commented, “We believe we are at an inflection point in Adial’s journey. With the successful completion of our End of Phase 2 meeting with the Food and Drug Administration (FDA), we have received critical input from the FDA on the clinical and statistical design of our upcoming Phase 3 trial for AD04, our lead investigational drug and a serotonin‑3 receptor antagonist being developed for the treatment of Alcohol Use Disorder (AUD). This includes agreement on key protocol elements—such as patient population, endpoints, biomarker stratification, and adaptive enrichment strategies—all of which are designed to increase the likelihood of success and support a streamlined path to approval. We expect to receive the official meeting minutes from the FDA within 30 days of the meeting date.”

“Additionally, our collaboration with Cytel has been instrumental in shaping a precision‑driven, data‑informed strategy. By applying advanced machine learning tools and simulation modeling, we’ve identified genetically defined subgroups most likely to benefit from AD04. This enables us to pursue a highly targeted and efficient Phase 3 program, with the potential for interim analyses that could accelerate timelines and increase value creation for shareholders.”

“In parallel, we have secured U.S.-based manufacturing agreements with Thermo Fisher Scientific and Cambrex to ensure robust drug product and drug substance supply. These partnerships not only provide the clinical and commercial manufacturing capacity we need but also reduce supply chain risk and strengthen our Chemistry, Manufacturing, and Controls (CMC) position for future NDA submission. The demonstration batches are already complete, and we’re well positioned to initiate registration and validation batches in support of the clinical program.”

“We look forward to advancing the clinical program for AD04 and with our progress on the regulatory, clinical, and manufacturing fronts, we are optimistic about achieving a successful outcome in the Phase 3 program. These accomplishments are also catalyzing strategic partnership discussions, which we believe will accelerate now that we’ve met this critical FDA milestone. We remain committed to disciplined execution and believe AD04 has the potential to be the first genetically targeted therapy approved for AUD, a market with enormous unmet need and commercial potential.”

**Other Developments**

_Nasdaq_

On July 16, 2025, Adial announced that it received notice from Nasdaq on July 14, 2025 that the Company has regained compliance with Nasdaq Listing Rule 5550(b)(1), which requires listed companies to maintain stockholders’ equity of at least $2,500,000.

_Intellectual Property_

On July 9, 2025, Adial announced the filing of an update to the provisional patent application for AD04 which was filed in July 2024, the Company’s lead investigational genetically targeted, serotonin‑3 receptor antagonist, therapeutic agent for the treatment of AUD in heavy drinking patients (defined as < 10 drinks/day). The patent, once granted, is expected to protect Adial’s core assets out to at least 2045.

_Financing_

On June 17, 2025, Adial announced a public offering for the purchase and sale of 11,100,000 shares of common stock of the Company (or common stock equivalents in lieu thereof), together with Series D warrants to purchase up to 11,100,000 shares of common stock and Series E warrants to purchase up to 8,325,000 shares of common stock at a combined offering price of $0.3251 per share and accompanying warrants, for aggregate net proceeds of approximately $3.0 million. The Company intends to use the net proceeds of this offering for working capital and general corporate purposes.

**Second Quarter 2025 Financial Results**

Cash and cash equivalents were $5.9 million as of June 30, 2025, compared to $2.4 million as of March 31, 2025. The Company believes that its existing cash and cash equivalents will fund its operating expenses into the second quarter of 2026 based on currently committed development plans. Research and development expenses decreased by approximately $281 thousand (28%) during the three months ended June 30, 2025, compared to the three months ended June 30, 2024. General and administrative expenses decreased by approximately $125 thousand (10%) during the three months ended June 30, 2025, compared to the same period in 2024. Net Loss was $2.0 million for the three months ended June 30, 2025, compared to a net loss of $2.5 million for the three months ended June 30, 2024.

**About Adial Pharmaceuticals, Inc.**

Adial Pharmaceuticals is a clinical‑stage biopharmaceutical company focused on the development of therapies for the treatment and prevention of addiction and related disorders. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin‑3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients and was recently investigated in the Company’s ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes identified using the Company’s proprietary companion diagnostic genetic test. ONWARD showed promising results in reducing heavy drinking in heavy drinking patients, and no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity.

Adial's Genetic-Targeted Alcohol Treatment Heads to Phase 3 After FDA Green Light

Adial Pharmaceuticals reported Q2 2025 financial results and announced progress on its lead drug AD04 for alcohol use disorder, including a successful FDA End‑of‑Phase‑2 meeting, new U.S. manufacturing agreements, and a $3 million public offering that raised cash to $5.9 million. The company also regained Nasdaq compliance, filed a provisional patent, and expects its cash runway to last into Q2 2026.