Core Viewpoint - Adial Pharmaceuticals is making significant progress in the development of its lead investigational drug AD04 for the treatment of Alcohol Use Disorder (AUD), with key milestones achieved in the second quarter of 2024 [2][3]. Company Developments - The company initiated a pharmacokinetics study of AD04 in June 2024, with topline results expected in the fourth quarter of 2024, which will inform the design of the planned Phase 3 clinical trial [2][3]. - A collaboration agreement was established with Boudicca Dx to support the development of a companion diagnostic genetic test, ensuring compliance with FDA guidelines [3]. - A new patent application was filed on July 31, 2024, to protect core assets and extend intellectual property until 2044 [4]. - Recent publications in peer-reviewed journals have highlighted the efficacy and safety profile of AD04, demonstrating its potential as a precision medicine for AUD [4]. Financial Results - As of June 30, 2024, cash and cash equivalents were $3.3 million, an increase from $2.8 million at the end of 2023 [5]. - The company raised approximately $3.8 million from its at-the-market facility after the quarter ended, which is expected to fund operations into the second half of 2025 [5]. - Research and development expenses rose by approximately $583 thousand compared to the same period in 2023, primarily due to clinical trial expenses [6]. - The net loss for the second quarter of 2024 was $2.5 million, a significant change from a net income of $1.1 million in the same quarter of 2023, which included a one-time gain from the sale of Purnovate [6].

Financial Performance - The company reported net losses of approximately $8.9 million and $5.1 million for the six months ended June 30, 2024, and the year ended December 31, 2023, respectively[87]. - Accumulated deficits were approximately $77.7 million and $68.8 million as of June 30, 2024, and December 31, 2023, respectively[87]. - Loss from continuing operations for the six months ended June 30, 2024, was approximately $8.9 million, compared to a loss of $3.75 million for the same period in 2023[102]. - Losses from equity method investment increased by approximately $412,000 due to the acquisition of Adovate, LLC on June 30, 2023[106]. - Loss from discontinued operations decreased by approximately $1,932,000 (100%) as the business of Purnovate, Inc. was sold in June 2023[109]. Expenses - Research and development expenses increased by approximately $671,000 (84%) in the six months ended June 30, 2024, compared to the same period in 2023[104]. - General and administrative expenses decreased by approximately $286,000 (10%) in the six months ended June 30, 2024, compared to the same period in 2023[102]. - Total operating expenses for the six months ended June 30, 2024, were $4.1 million, an increase of $385,000 compared to the same period in 2023[102]. - Inducement expense of approximately $4,464,000 was recognized as a one-time, noncash expense related to the issuance of new warrants[107]. Revenue and Cash Flow - The company has not generated any significant revenue since inception and does not expect current cash and cash equivalents to be sufficient to fund operations for the next twelve months[86][88]. - Net cash used in operating activities increased by approximately $567,000 in the six months ended June 30, 2024, compared to the same period in 2023[118]. - Net cash provided by financing activities increased by approximately $3,625,000, driven by the sale of common stock and warrant exercises[122]. - Total other income increased by $77,000 (2567%) due to higher interest income and a one-time expense in the prior year[108]. Future Financing and Development - The company expects to finance operations through a combination of equity offerings, debt financings, and other collaborations, but may face challenges in raising additional funds[89]. - The company expects to use approximately $10-15 million in cash during the twelve months ended June 30, 2025 for AD04 development costs and general corporate expenses[114]. - The company will require additional financing to execute its overall business strategy, including two additional Phase 3 trials for AD04, expected to require $8-12 million each[115]. - The company initiated a Phase 1 pharmacokinetic study of AD04 with an estimated total cost of approximately $1.4 million[113]. Clinical Development Focus - The company is focused on completing the clinical development program for its investigational drug candidate AD04, primarily in the U.S. and secondarily in Europe/UK[84].

Core Insights - Adial Pharmaceuticals has completed patient dosing for the second cohort in the pharmacokinetics study of AD04, with topline results expected in Q4 2024 [1][2] - The completion of dosing is a significant milestone towards initiating a Phase 3 clinical trial aimed at optimizing dosing for AD04 in patients with Alcohol Use Disorder (AUD) [2] - The study involved 30 healthy adult volunteers and compared the pharmacokinetic profile of AD04 at a dose of 0.33 mg, with or without food, against a reference standard product [2] Company Overview - Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing treatments for addiction and related disorders [3] - The lead investigational product, AD04, is a genetically targeted serotonin-3 receptor antagonist for treating AUD in heavy drinking patients [3] - AD04 has shown promising results in reducing drinking in heavy drinking patients during the ONWARD™ pivotal Phase 3 clinical trial, with no significant safety or tolerability concerns [3] - The company believes AD04 may also have potential applications in treating other addictive disorders such as Opioid Use Disorder, gambling, and obesity [3]

GLEN ALLEN, Va., July 31, 2024 (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 a new patent application for AD04, the Company's lead investigational genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients (defi ...

GLEN ALLEN, Va., July 31, 2024 (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 a new patent application for AD04, the Company’s lead investigational genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients (def ...

Adial Pharmaceuticals (NASDAQ:ADIL) stock is rocketing higher on Tuesday after the clinical-stage biopharmaceutical company announced an update on its AD04 study.Adial Pharmaceuticals notes that AD04 is progressing to a second cohort in its pharmacokinetics study. This comes after the success of its first cohort as a treatment for Alcohol Use Disorder (AUD).Adial Pharmaceuticals notes that this study started last month and is expected to reach completion during the fourth quarter of this year. The data from ...

GLEN ALLEN, Va., July 23, 2024 (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 progression to the second cohort in the pharmacokinetics study of AD04, the Company's lead investigational genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in he ...

GLEN ALLEN, Va., June 20, 2024 (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 publication of previously disclosed results from its Phase 3 ONWARD study in a peer-reviewed article in the European Journal of Internal Medicine entitled, "Low-dose ondansetron: A candidate prospective precision medicine to treat al ...

GLEN ALLEN, Va., June 20, 2024 (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 publication of previously disclosed results from its Phase 3 ONWARD study in a peer-reviewed article in the European Journal of Internal Medicine entitled, “Low-dose ondansetron: A candidate prospective precision medicine to treat a ...

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