Core Viewpoint - Adial Pharmaceuticals will implement a 1-for-25 reverse stock split to comply with Nasdaq's minimum bid price requirement and enhance its capital markets profile, effective February 5, 2026 [1][3][4] Group 1: Reverse Stock Split Details - The reverse stock split will reduce the number of outstanding shares from approximately 27.8 million to about 1.1 million, while maintaining the ownership percentage of existing shareholders [2] - The new CUSIP number for the common stock post-split will be 00688A304, and trading on a split-adjusted basis will commence on February 6, 2026 [1][2] Group 2: Compliance and Market Strategy - The reverse split aims to ensure compliance with Nasdaq's requirement of a minimum bid price of $1.00 per share, making the stock more appealing to institutional and retail investors [3] - The company believes this action will strengthen its capital markets profile and create a more efficient public float, supporting broader investor interest [4] Group 3: Company Overview and Future Plans - Adial Pharmaceuticals is focused on developing treatments for addiction, with its lead product AD04 targeting Alcohol Use Disorder [5] - The company plans to conduct a new Phase 3 clinical trial for AD04, which has shown promising results in reducing drinking among heavy drinkers [5]

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].

Financial Results - Adial Pharmaceuticals, Inc. reported financial results for the quarter ended September 30, 2025, in a press release issued on November 14, 2025[5]. - The report indicates that the financial information is not deemed "filed" under the Securities Exchange Act of 1934, thus limiting liability under certain sections[6]. - The report does not provide specific performance metrics or user data in the available content[5]. - There is no mention of future outlook, product development, market expansion, or mergers and acquisitions in the provided documents[5]. Company Information - The company is listed on the Nasdaq Stock Market under the trading symbol ADIL[3]. - The press release is attached as Exhibit 99.1 to the Current Report on Form 8-K[7]. - The company has not elected to use the extended transition period for complying with new financial accounting standards[4]. - The company is classified as an emerging growth company[4]. - The address of the company's principal executive offices is 4870 Sadler Road, Suite 300, Glen Allen, VA 23060[3]. - Cary J. Claiborne serves as the President and Chief Executive Officer of Adial Pharmaceuticals, Inc.[12].

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]

Financial Performance - The company reported net losses of approximately $6.0 million and $13.2 million for the nine months ended September 30, 2025, and the year ended December 31, 2024, respectively[87]. - As of September 30, 2025, the company had accumulated deficits of approximately $88 million, up from $82 million as of December 31, 2024[87]. - Net loss for the nine months ended September 30, 2025, was $5,981,000, a decrease of $5,145,000 compared to a net loss of $11,126,000 in the same period in 2024[118]. - Total other income increased by $147,000 (118%) for the nine months ended September 30, 2025, due to a milestone payment of $150,000 received from Adovate[108]. - Net cash used in operating activities decreased by approximately $300,000 for the nine months ended September 30, 2025, compared to the same period in 2024[119]. - Financing activities provided approximately $5,874,000 for the nine months ended September 30, 2025, a decrease of $1,972,000 compared to $7,846,000 in the same period in 2024[121]. Expenses - Research and development expenses decreased by approximately $511,000 (50%) during the three months ended September 30, 2025, compared to the same period in 2024[99]. - General and administrative expenses increased by approximately $63,000 (5%) during the three months ended September 30, 2025, compared to the same period in 2024[100]. - Research and development expenses decreased by approximately $498,000 (20%) for the nine months ended September 30, 2025, compared to the same period in 2024[104]. - General and administrative expenses increased by approximately $69,000 for the nine months ended September 30, 2025, primarily due to higher compensation expenses[105]. - The inducement expense of approximately $4,464,000 was a one-time, noncash expense associated with the issuance of new warrants in the nine months ended September 30, 2024[107]. Cash Position and Funding - The company expects that current cash and cash equivalents will not be sufficient to fund operations for the next twelve months, raising substantial doubt about its ability to continue as a going concern[86]. - Cash and cash equivalents at September 30, 2025, were $4.6 million, expected to fund operations into the second quarter of 2026[115]. - 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[116]. - The company completed a warrant inducement transaction in May 2025, generating net proceeds of approximately $2.2 million[91]. - The June 2025 Offering resulted in aggregate net proceeds of approximately $3.0 million from the sale of shares and warrants[94]. - The company sold 1,869,996 shares under the At the Market Offering, receiving net proceeds of approximately $478,000 during the three and nine months ended September 30, 2025[96]. Future Plans - The company plans to begin a Phase III study of AD04 in the first half of 2026, pending adequate funding and regulatory approvals[115]. - The company is focused on completing the clinical development program for its investigational drug candidate AD04, primarily in the US and secondarily in Europe/UK[83].

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]

Upgrades Summary - Morgan Stanley upgraded Celsius Holdings (CELH) to Overweight from Equal Weight with a price target of $70, up from $61, citing a return to growth and expected reacceleration in topline growth due to easier comparisons from December through early June [2] - UBS upgraded FIS (FIS) to Buy from Neutral with an unchanged price target of $82, believing the risk/reward profile has improved as shares are down 20% year-to-date [2] - Oppenheimer upgraded Semtech (SMTC) to Outperform from Perform with a price target of $81, following positive management meetings and a bullish outlook on growth opportunities in data center artificial intelligence [2] - BofA upgraded Freeport-McMoRan (FCX) to Buy from Neutral with an unchanged price target of $42, expressing increased confidence in the current valuation despite risks associated with the halted Grasberg copper/gold mine in Indonesia [2] - Maxim upgraded Adial Pharmaceuticals (ADIL) to Buy from Hold with a price target of $1.50, reflecting a more bullish stance on the company [2]

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]