Scope of Agreement with Cambrex to Provide Ondansetron HCL Drug Substance Under FDA Approved Drug Master File Scope Of Agreement With Thermo Fisher to Provide Manufacturing Services Including Demonstration, Clinical, Registration And Validation Batches of AD04 for US Clinical Trials And NDA Submission GLEN ALLEN, Va., June 25, 2025 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the trea ...

GLEN ALLEN, Va., June 17, 2025 (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 the pricing of its "reasonable best efforts" 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 ...

"Adial's collaboration with Cytel reinforces our commitment to disciplined capital deployment and data-driven execution," said Cary Claiborne, CEO at Adial. "By leveraging advanced analytics and adaptive design, we are in a strong position to generate meaningful clinical data while minimizing time and spend. We believe this strategy materially increases the probability of success for AD04 and creates significant value for patients and shareholders alike." Adial's platform is focused on developing geneticall ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Date of Report (date of earliest event reported): May 15, 2025 Adial Pharmaceuticals, Inc. (Exact name of registrant as specified in charter) (State or other jurisdiction of incorporation) Delaware 001-38323 82-3074668 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 (Commission File Number) (IRS Employer Identification No.) 4870 Sadler Road, Ste 300 Glen Allen, VA 23060 (Address of principa ...

Other Developments Adovate, LLC On May 13, 2025, Adial announced that it has received a six-figure development milestone payment from Adovate, LLC, following the commencement of a Phase 1 clinical trial evaluating Adovate's lead compound for asthma, ADO-5030. This milestone payment follows Adovate's exercise of its option to acquire the assets and business of Purnovate, Inc., a wholly owned subsidiary of Adial Pharmaceuticals, as previously disclosed. Under the terms of the agreement with Adovate, Adial is ...

Financial Performance - The company reported a net loss of approximately $2.2 million for the three months ended March 31, 2025, compared to a net loss of $6.5 million for the same period in 2024, representing a decrease of $4.3 million[87]. - The company has accumulated deficits of approximately $84.2 million as of March 31, 2025, indicating ongoing financial challenges[78]. - The company has incurred recurring losses and needs to raise additional funds to sustain operations, raising substantial doubt about its ability to continue as a going concern[77]. Expenses - Research and development expenses increased by approximately $293,000 (65%) during the three months ended March 31, 2025, driven by increased chemistry, manufacturing, and controls expenses[88]. - General and administrative expenses rose by approximately $129,000 (9%) during the same period, primarily due to higher compensation and consulting costs[89]. Cash and Financing - The company had cash and cash equivalents of $2.4 million as of March 31, 2025, which increased to approximately $3.9 million by May 12, 2025[97]. - The company received net proceeds of approximately $2.35 million from a warrant inducement agreement that closed on May 5, 2025, to support working capital[84]. - The company expects to require $8-12 million for each of the two additional Phase 3 trials for AD04, along with up to $5 million in other development expenses[98]. - The company has no committed sources of funding and is restricted by SEC and Nasdaq rules regarding its ATM Agreement and equity line[99]. - The company is actively pursuing financing and other strategic plans but cannot assure that such financing will be available on acceptable terms[99]. Cash Flow - Net cash used in operating activities decreased by approximately $41,000, from $1,626,000 in Q1 2024 to $1,585,000 in Q1 2025[102]. - Net cash provided by investing activities increased by approximately $150,000 due to a milestone payment received from Adovate[103]. - Net cash provided by financing activities decreased by approximately $3,774,000, from $3,824,000 in Q1 2024 to $51,000 in Q1 2025[104]. - The company reported a net increase in cash and cash equivalents of $(1,384,000) in Q1 2025 compared to an increase of $2,198,000 in Q1 2024[101]. Research and Development - The company plans to begin a Phase III study of AD04 in the second half of 2025, with a contract signed for approximately $2.3 million to produce sufficient drug product for the study[97]. - The FDA has accepted a new in-vitro bridging strategy for AD04, allowing for heavy-drinking-day based endpoints for approval instead of abstinence-based endpoints[82]. - Without additional funding, the company may need to delay, scale back, or eliminate some or all of its research and development programs[99]. Accounting and Estimates - The company does not have any off-balance sheet arrangements[105]. - The company has not identified any critical accounting estimates that could materially affect its financial condition[107].

Core Insights - Adial Pharmaceuticals has achieved a milestone by receiving a six-figure payment from Adovate, LLC, following the initiation of a Phase 1 clinical trial for ADO-5030, a novel asthma therapy targeting a significant market with unmet medical needs [1][2][3] Company Overview - Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies for addiction and related disorders, with its lead product AD04 targeting Alcohol Use Disorder (AUD) [4] Financial Aspects - Under the agreement with Adovate, Adial is eligible for over $50 million in commercial milestone payments and an additional $11 million in development and approval milestone payments per compound, totaling up to $83 million for the first three compounds if milestones are achieved [3][7] - Adial retains a significant equity stake of over 10% in Adovate, allowing participation in the long-term upside as the asthma candidate progresses [3][7] Clinical Development - The ongoing Phase 1 study for ADO-5030 is a Single Ascending Dose (SAD) trial aimed at evaluating safety, tolerability, and pharmacokinetics in healthy volunteers, with the potential to shift the treatment paradigm for asthma patients globally [2][3]

Core Viewpoint - Adial Pharmaceuticals is progressing towards a Phase 3 clinical trial for its lead drug candidate AD04, aimed at treating Alcohol Use Disorder (AUD), with an important FDA meeting scheduled for July 25, 2025 to discuss the clinical development plan and trial design [2][3]. Company Overview - Adial Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for addiction and related disorders [4]. - The lead investigational drug, AD04, is a genetically targeted serotonin-3 receptor antagonist designed for heavy drinking patients with AUD [4]. - AD04 has shown promising results in the ONWARD™ pivotal Phase 3 clinical trial, demonstrating effectiveness in reducing drinking without significant safety concerns [4]. Clinical Development - The FDA has granted Adial an End of Phase 2 meeting to discuss the proposed clinical development plan and seek guidance on the Phase 3 adaptive trial design for AD04 [2]. - The company has confirmed its 505(b)(2) regulatory bridging strategy with the FDA, indicating strong progress in trial design [3]. - The target patient population for AD04 has been reinforced through recent analyses, supporting its potential effectiveness in treating AUD and related conditions [3]. Future Prospects - The company is optimistic about aligning with the FDA on key requirements to advance AD04 and plans to provide a comprehensive update after the July meeting [3]. - AD04 is also believed to have potential applications in treating other addictive disorders, including Opioid Use Disorder, gambling, and obesity [4].

Core Viewpoint - Adial Pharmaceuticals, Inc. has entered into a warrant inducement agreement with an institutional investor for the immediate exercise of existing Series B and Series C Warrants, aiming to raise approximately $2.75 million for working capital and corporate purposes [1][3]. Group 1: Warrant Inducement Agreement - The agreement involves the exercise of Series B Warrants to purchase up to 1,418,440 shares and Series C Warrants for up to 2,300,000 shares at a reduced exercise price of $0.74 [1]. - In exchange for the immediate exercise of the Existing Warrants, the investor will receive new Series B-1 and Series C-1 Warrants, allowing the purchase of up to 2,482,270 and 4,025,000 shares respectively, also at an exercise price of $0.74 [3]. - The closing of this transaction is expected around May 5, 2025, pending customary closing conditions [3]. Group 2: Use of Proceeds - The net proceeds from this 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 a pivotal Phase 3 clinical trial, indicating potential effectiveness in reducing drinking among heavy drinkers with specific genetic profiles [6]. - The company also believes AD04 may be effective in treating other addictive disorders, including Opioid Use Disorder, gambling, and obesity [6].

Core Viewpoint - Adial Pharmaceuticals has received a new patent for a treatment method targeting a wide range of alcohol-related disorders and opioid-related disorders using its investigational drug AD04, which is tailored for genetically identified patients [1][2][3] Group 1: Patent and Intellectual Property - The newly issued patent number 12,274,692 covers a precision medicine approach for administering AD04 to patients with specific genetic markers related to serotonin [2] - The patent includes claims for treating various alcohol-related disorders, such as alcohol-induced anxiety, bipolar disorder, sexual dysfunction, sleep disorders, gambling disorder, and alcohol withdrawal [2] Group 2: Company Mission and Development - The CEO of Adial Pharmaceuticals emphasized the significance of this patent as a milestone in providing targeted treatments for individuals suffering from alcohol and opioid use disorders [3] - The company is committed to advancing AD04 through clinical development and regulatory pathways to meet the urgent need for effective, personalized addiction treatments [3] Group 3: Product and Clinical Trials - AD04 is a genetically targeted serotonin-3 receptor antagonist aimed at treating Alcohol Use Disorder (AUD) in heavy drinking patients, with promising results from the ONWARD™ pivotal Phase 3 clinical trial [4] - The ONWARD trial demonstrated effectiveness in reducing heavy drinking without significant safety or tolerability concerns [4]