Core Insights - Adial Pharmaceuticals, Inc. has welcomed the recent passage of the 2026 Appropriations Bill, which includes directives for the FDA and NIDA to establish alternative clinical trial endpoints for substance use disorder treatments, including Alcohol Use Disorder (AUD) [1][2][5] Group 1: Legislative Impact - The legislation directs the FDA to consider non-abstinence-based endpoints such as reduced cravings and disorder severity, reflecting clinically meaningful improvements for patients [2][3] - This directive aligns with the NIAAA's updated definition of recovery, which emphasizes improvements in functioning and symptom reduction as valid treatment goals [3] Group 2: Company Strategy and Product Development - Adial's lead investigational therapy, AD04, is designed to treat AUD using a precision medicine approach, aligning with the newly established non-abstinence recovery outcomes [4][5] - The collaboration between federal agencies to define alternative endpoints is expected to strengthen the regulatory framework for innovative therapies like AD04, potentially accelerating development timelines and broadening clinical relevance [4][5] Group 3: Market Context - AUD remains a significant public health challenge, affecting millions with limited treatment options that achieve durable outcomes [5] - Adial believes that regulatory clarity around alternative endpoints will enhance the regulatory path for AD04 and support the company's strategy to address the unmet need in AUD with precision-based therapies [5][6]

GLEN ALLEN, Va., Feb. 03, 2026 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced that it will effect a 1-for-25 reverse stock split (the “Reverse Split”) of its common stock, par value $0.001 per share (“Common Stock”), that will become effective on February 5, 2026 at 11:59 p.m. Eastern Time (the “Effective T ...

GLEN ALLEN, Va., Feb. 03, 2026 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ:ADIL) ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced that it will effect a 1-for-25 reverse stock split (the "Reverse Split") of its common stock, par value $0.001 per share ("Common Stock"), that will become effective on February 5, 2026 at 11:59 p.m. Eastern Time (the "Effective Ti ...

Common Stock Will Begin Trading on Split-Adjusted Basis on February 6, 2026GLEN ALLEN, Va., Feb. 03, 2026 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced that it will effect a 1-for-25 reverse stock split (the “Reverse Split”) of its common stock, par value $0.001 per share (“Common Stock”), that will become ...

Core Insights - Adial Pharmaceuticals has announced the publication of an international patent application for its lead investigational drug AD04, aimed at treating Alcohol Use Disorder (AUD) in heavy drinking patients, with patent protection expected to last until at least 2045 [1][2] Company Overview - Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies for addiction and related disorders, with AD04 being a genetically targeted serotonin-3 receptor antagonist [3] - The company is planning a new Phase 3 clinical trial program for AUD, utilizing a proprietary diagnostic genetic test to identify target genotypes [3] Clinical Development - The ONWARD trial for AD04 has shown promising results in reducing drinking among heavy drinking patients, with no significant safety or tolerability concerns reported [3] - AD04 is also believed to have potential applications in treating other addictive disorders, including Opioid Use Disorder, gambling, and obesity [3]

Core Viewpoint - Adial Pharmaceuticals has entered into a warrant inducement agreement with an institutional investor for the immediate exercise of existing warrants, aiming to raise approximately $2.86 million for working capital and corporate purposes [1][3]. Group 1: Warrant Inducement Agreement - The agreement involves the immediate exercise of Series C-1 Warrants to purchase up to 4,025,000 shares and Series E Warrants to purchase up to 5,190,675 shares at a reduced exercise price of $0.31 [1]. - The investor will receive new unregistered Series F Warrants to purchase up to 13,823,512 shares, with the same exercise price of $0.31, which will be exercisable upon shareholder approval [3]. - The closing of this transaction is expected around December 1, 2025, subject to customary closing conditions [3]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for working capital and other general corporate purposes [1]. Group 3: Company Overview - Adial Pharmaceuticals is focused on developing therapies for addiction and related disorders, with its lead product AD04 targeting Alcohol Use Disorder (AUD) [6]. - AD04 has shown promising results in reducing heavy drinking in patients during the ONWARD™ pivotal Phase 3 clinical trial, with no significant safety concerns reported [6]. - The company believes AD04 may also have potential applications for treating other addictive disorders such as Opioid Use Disorder, gambling, and obesity [6].

Core Insights - Adial Pharmaceuticals is progressing towards FDA approval for its lead drug AD04, aimed at treating Alcohol Use Disorder (AUD) with a focus on biomarker-positive patients [2][5] - The company has received guidance from the FDA following a successful End of Phase 2 meeting, which will inform the design of its upcoming Phase 3 study [2] - Recent bipartisan support from the U.S. Senate for broader clinical trial endpoints reinforces Adial's patient-centered approach to treatment [2] Company Developments - Adial has partnered with Genomind to develop a precision medicine testing solution, completing validation for a cheek swab method to identify eligible patients [2] - The company filed an update to its provisional patent application for AD04, which is expected to protect its core assets until at least 2045 [3] Financial Results - As of September 30, 2025, Adial reported cash and cash equivalents of $4.6 million, down from $5.9 million as of June 30, 2025, with expectations to fund operations into Q2 2026 [4] - Research and development expenses decreased by approximately $511 thousand (50%) year-over-year, attributed to lower clinical activity [8] - General and administrative expenses increased by approximately $63 thousand (5%) due to the timing of the annual meeting [8] - The net loss for Q3 2025 was $1.8 million, an improvement from a net loss of $2.2 million in Q3 2024, primarily due to reduced R&D spending [8]

Core Viewpoint - Adial Pharmaceuticals, Inc. is gaining visibility through CEO Cary Claiborne's appearance on the Big Biz Show, which could enhance the company's profile in the biopharmaceutical industry focused on addiction treatment [1][2]. Company Overview - Adial Pharmaceuticals is a clinical-stage biopharmaceutical company dedicated to developing therapies for addiction and related disorders [3]. - The company's lead product, AD04, is a genetically targeted serotonin-3 receptor antagonist aimed at treating Alcohol Use Disorder (AUD) in heavy drinking patients [3]. - AD04 has shown promising results in the ONWARD™ pivotal Phase 3 clinical trial, demonstrating effectiveness in reducing drinking among heavy drinkers without significant safety or tolerability issues [3]. - The potential applications of AD04 extend to other addictive disorders, including Opioid Use Disorder, gambling, and obesity [3].

Core Insights - Adial Pharmaceuticals has successfully completed the analytical validation of a cheek swab collection method for testing patients with genotypes relevant to the development of AD04, marking a significant milestone towards FDA registration [1][4][5] Partnership and Development - The partnership with Genomind aimed to develop an analytically validated gene test in a CLIA-certified laboratory to identify important SNPs for the upcoming Phase 3 program for AD04, facilitating the creation of a commercial companion diagnostic test [2][3] - Adial is aligning with FDA recommendations following the End of Phase 2 meeting, ensuring readiness for registrational Phase 3 development, targeting patients who are biomarker positive for AG+, which is present in approximately 14% of the general population [4][5] Clinical and Commercial Strategy - The cheek swab collection method is designed to be patient and physician-friendly, allowing for easy sample collection in various settings, which is expected to enhance patient identification for AD04 therapy [5][6] - The assay developed in collaboration with Genomind demonstrated 100% concordance across all SNP testing, validating its accuracy and robustness [6][7] Future Outlook - The completion of this milestone is seen as a commitment to precision medicine, integrating pharmacogenetic insights into the development strategy, which is expected to enhance clinical predictability and set a new benchmark for targeted therapeutics in neuropsychiatry [5][7] - Adial's new patent filing for AD04 is anticipated to extend market exclusivity to 2045, framing the AD04 program as a highly attractive commercial opportunity with significant patient impact [5][9]

Core Insights - Adial Pharmaceuticals has received positive feedback from the FDA regarding the Phase 3 clinical trial design for its lead drug AD04, aimed at treating Alcohol Use Disorder (AUD) [1][5][6] - The FDA's input is seen as a significant milestone that enhances the clinical and statistical framework for the upcoming trial, positioning the company for potential commercial success [4][5][7] FDA Meeting Outcomes - The EOP2 Meeting aimed to align on the design of the Phase 3 clinical development program for AD04, a serotonin-3 receptor antagonist targeting individuals with heavy drinking and specific genotypes [2][6] - Key elements discussed included target population, clinical endpoints, inclusion/exclusion criteria, dosing regimen, and biomarker stratification [2][6] - The FDA confirmed primary efficacy endpoints, specifically targeting zero heavy drinking days during months 5 and 6 of the observation period [6] Development Strategy - Adial is implementing FDA recommendations to ensure readiness for registrational Phase 3 development, focusing on patients who are biomarker positive for AG+, which represents about 14% of the general population [4][6] - The company emphasizes a commitment to precision medicine by integrating pharmacogenetic insights and validated biomarkers into its development strategy [5][6] Commercial Potential - The recent patent filing for AD04 may extend market exclusivity to 2045, framing the program as a highly attractive commercial opportunity [5][6] - The company aims to address a large, underserved patient population, potentially becoming the first genetically targeted therapy for AUD [7]