Core Insights - Adial Pharmaceuticals has submitted a briefing package for the End of Phase 2 meeting with the FDA, now rescheduled for July 29, 2025, to discuss the clinical development plan for its lead drug AD04 [1][5] - The objective of the meeting is to align with the FDA on the Phase 3 clinical development program for AD04, which targets Alcohol Use Disorder (AUD) [3][4] - A successful outcome from the meeting is expected to enhance Adial's strategic partnership discussions, as regulatory clarity is crucial for potential collaborators [4][5] Company Overview - Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies for addiction and related disorders, with AD04 being a serotonin-3 receptor antagonist aimed at treating AUD in heavy drinkers [2][6] - The ONWARD™ pivotal Phase 3 clinical trial for AD04 has shown promising results in reducing drinking among heavy drinkers without significant safety concerns [6] Clinical Development - The briefing package for the EOP2M includes comprehensive safety data, efficacy studies, and statistical analysis conducted in collaboration with Cytel Inc. [3] - Key elements of the planned Phase 3 study design include population, endpoints, inclusion/exclusion criteria, and dose regime [3] Strategic Partnerships - Clarity and validation from the FDA are anticipated to strengthen Adial's position in discussions with potential partners, as regulatory momentum is viewed as a key de-risking milestone [4][5]

Core Insights - Adial Pharmaceuticals is advancing its Phase 3 trial for AD04, a treatment for Alcohol Use Disorder (AUD), with the support of Cytel's machine learning technology for data analysis and trial design [1][2][4] Group 1: Trial Design and Strategy - The collaboration with Cytel aims to enhance trial design efficiency, cost-effectiveness, and success likelihood by identifying genetic subpopulations that may respond better to AD04 [2][4][7] - Adial's precision medicine approach focuses on targeting specific patient subgroups to improve efficacy and commercial differentiation in the upcoming trial [7][8] Group 2: Market Potential and Product Overview - AD04 is positioned as a first-in-class opportunity in the multi-billion-dollar global AUD market, with potential applications for other addictive disorders such as Opioid Use Disorder, gambling, and obesity [4][5][8] - The ONWARD™ pivotal Phase 3 clinical trial previously showed promising results in reducing drinking among heavy drinking patients without significant safety concerns [5][8] Group 3: Upcoming Milestones - The precision-focused Phase 3 trial is expected to commence in late 2025, with possibilities for interim analysis-driven readouts to facilitate regulatory submission [7][8]

[Form 8-K Current Report](index=1&type=section&id=Form%208-K%20Current%20Report) This report details significant events or information that shareholders should be aware of, as required by the Securities Exchange Act [Item 2.02. Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02.%20Results%20of%20Operations%20and%20Financial%20Condition) This section details the company's financial results for the quarter ended March 31, 2025, as announced in a press release, noting its 'furnished' status under the Exchange Act - The company issued a press release on May 15, 2025, which included financial information for the quarter ended March 31, 2025[5](index=5&type=chunk) - The press release is attached as Exhibit 99.1 to the Form 8-K report[5](index=5&type=chunk) - The information furnished in this report, including Exhibit 99.1, is not deemed "filed" under Section 18 of the Exchange Act and is not incorporated by reference into any other SEC filings[6](index=6&type=chunk) [Item 9.01. Financial Statements and Exhibits](index=2&type=section&id=Item%209.01.%20Financial%20Statements%20and%20Exhibits) This section provides a comprehensive list of exhibits accompanying the Form 8-K, including the financial press release and interactive data file List of Exhibits | Exhibit Number | Description | | :--- | :--- | | 99.1 | Press Release issued by Adial Pharmaceuticals, Inc., dated May 15, 2025 | | 104 | Cover Page Interactive Data File (embedded within the XBRL document) |

Core Insights - Adial Pharmaceuticals has made significant progress in the first quarter of 2025, particularly in advancing its lead investigational drug AD04 for Alcohol Use Disorder (AUD) [2] - The company successfully completed a pharmacokinetics bridging study, confirming favorable bioavailability of AD04, and has begun manufacturing clinical trial supplies [2] - Regulatory alignment with the FDA has been achieved, supporting a streamlined path for the upcoming Phase 3 clinical trial [2] - Adial has strengthened its intellectual property portfolio with multiple granted patents related to AD04 [5] Financial Results - As of March 31, 2025, cash and cash equivalents were $2.4 million, down from $3.8 million as of December 31, 2024 [12] - Research and development expenses increased by approximately $293 thousand (65%) compared to the same period in 2024, driven by increased CMC expenses and consulting [12] - General and administrative expenses rose by approximately $129 thousand (9%) due to higher compensation and consulting [12] - The net loss for the first quarter of 2025 was $2.2 million, a decrease from a net loss of $6.5 million in the same quarter of 2024 [12] Strategic Developments - Adial received a six-figure milestone payment from Adovate, LLC, following the start of a Phase 1 clinical trial for an asthma compound [3] - The company is eligible for over $50 million in commercial milestone payments and an additional $11 million in development and approval milestone payments for the first three compounds [4] - Adial retains over a 10% equity stake in Adovate, allowing participation in the long-term upside as the asthma candidate progresses [4] Intellectual Property - A new patent was issued covering the administration of AD04 as a precision medicine approach for patients with specific genetic markers [5] Future Outlook - The company is preparing for an End of Phase 2 meeting with the FDA in July to finalize the Phase 3 trial design [2][13] - There is confidence in advancing AD04 through late-stage development, with potential applications for other addictive disorders such as Opioid Use Disorder, gambling, and obesity [9][13]

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]

Financial Results - Adial Pharmaceuticals, Inc. reported financial results for the fiscal year ended December 31, 2024, in a press release issued on March 4, 2025[5]. - The report does not include specific financial metrics or performance indicators in the provided content[6]. - The financial statements and exhibits are furnished with the Current Report on Form 8-K[7]. Company Information - The company is listed on the Nasdaq Stock Market under the trading symbol ADIL[3]. - The company has not indicated whether it is an emerging growth company[4]. - The report was signed by Cary J. Claiborne, President and Chief Executive Officer of Adial Pharmaceuticals, Inc.[11]. Press Release Details - The press release is attached as Exhibit 99.1 to the Current Report on Form 8-K[5]. - No details on user data, future outlook, or guidance were provided in the available documents[6]. - There is no mention of new products, technologies, market expansion, or mergers and acquisitions in the content[6]. - The report does not specify any new strategies or initiatives undertaken by the company[6].