UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (date of earliest event reported): August 14, 2025 (Address of principal executive offices and zip code) (804) 487-8196 (Registrant's telephone number including area code) N/A (Former name or former address, if changed since last report) Adial Pharmaceuticals, Inc. (Exact name of registrant as specified in charter) | Delaware | ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number: 001-38323 ADIAL PHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in its Charter) | Delaware | 82-3074668 | ...

Core Points - Adial Pharmaceuticals has regained compliance with Nasdaq Listing Rule 5550(b)(1), which requires a minimum stockholders' equity of $2,500,000 [1][2] - The CEO of Adial expressed that regaining compliance is a significant step in reinforcing investor confidence and supporting the company's long-term growth strategy [2] Company Overview - Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies for addiction and related disorders [2] - The lead investigational product, AD04, is a serotonin-3 receptor antagonist aimed at treating Alcohol Use Disorder (AUD) in heavy drinking patients [2] - The ONWARD™ pivotal Phase 3 clinical trial for AD04 showed promising results in reducing drinking among heavy drinkers without significant safety or tolerability concerns [2] - AD04 may also have potential applications in treating other addictive disorders such as Opioid Use Disorder, gambling, and obesity [2]

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GLEN ALLEN, Va., July 09, 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, 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 Alcoho ...

Core Viewpoint - Adial Pharmaceuticals has executed agreements with Cambrex and Thermo Fisher to support the production of its lead investigational drug AD04, aimed at treating Alcohol Use Disorder (AUD) in the U.S. [1][2][3] 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 [4]. - The company recently conducted the ONWARD™ pivotal Phase 3 clinical trial for AD04, which showed promising results in reducing drinking among heavy drinking patients without significant safety concerns [4]. Agreements and Collaborations - The collaboration with Thermo Fisher as the Contract Development and Manufacturing Organization (CDMO) and Cambrex as the drug substance supplier has commenced, focusing on the completion of demonstration batches necessary for clinical trials [2][3]. - The agreements encompass all manufacturing phases for clinical supplies and the Chemistry, Manufacturing, and Controls (CMC) documentation required for the NDA submission to the FDA [2]. Strategic Importance - The selection of CDMOs with proven track records in both drug substance development and manufacturing was crucial for the agreements [2]. - The partnerships are expected to be vital for meeting timelines for the upcoming Phase 3 clinical trials and addressing commercial demands for AD04, especially considering recent tariff implications [3]. Future Potential - AD04 is not only targeted for AUD but is also believed to have potential applications in treating other addictive disorders such as Opioid Use Disorder, gambling, and obesity [4].

Core Viewpoint - Adial Pharmaceuticals, Inc. has announced a public offering of 11,100,000 shares of common stock and associated warrants, aiming to raise approximately $3.6 million for working capital and general corporate purposes [1][3]. Group 1: Offering Details - The public offering includes Series D warrants to purchase up to 11,100,000 shares and Series E warrants to purchase up to 8,325,000 shares, priced at a combined offering price of $0.3251 per share [1]. - The Series D and Series E warrants will have an exercise price of $0.35 per share, with Series D warrants expiring five years from stockholder approval and Series E warrants expiring eighteen months from stockholder approval [2]. - The closing of the offering is expected on or about June 18, 2025, subject to customary closing conditions [3]. Group 2: Use of Proceeds - The net proceeds from the offering are intended for working capital and general corporate purposes [3]. Group 3: Existing Warrants Amendment - The company will amend existing Series B-1 and Series C-1 warrants to reduce their exercise price from $0.74 to $0.35 per share, subject to stockholder approval [4]. Group 4: Company Overview - Adial Pharmaceuticals is focused on developing therapies for addiction and related disorders, with its lead product AD04 targeting Alcohol Use Disorder (AUD) [7]. - AD04 has shown promising results in a pivotal Phase 3 clinical trial, indicating potential for treating other addictive disorders such as Opioid Use Disorder, gambling, and obesity [7].

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]