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A clinical-stage biotech focused on one drug for genetically-targeted alcohol use disorder, like an early-stage Biogen.

A precision medicine drug developer for alcohol addiction, similar to Genentech's targeted therapy approach.

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• AD04 for Alcohol Use Disorder (AUD): An investigational drug candidate developed for the treatment of Alcohol Use Disorder in individuals with specific genetic markers.

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Adial Pharmaceuticals (NASDAQ: ADIL) is a clinical-stage biopharmaceutical company focused on the development of pharmaceutical products for the treatment of addiction and related neurological disorders. Their lead product candidate, AD04, for Alcohol Use Disorder, is currently in clinical trials and has not yet been commercialized.

As a result, Adial Pharmaceuticals **does not currently have any major customers or generate revenue from product sales.** The company is primarily engaged in research, development, and clinical trial activities, working towards regulatory approval for its product candidates.

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Cary J. Claiborne, Chief Executive Officer

Cary J. Claiborne was named CEO of Adial Pharmaceuticals in August 2022, after serving as Chief Operating Officer from December 2021 and as a board member. He has over three decades of experience in leadership roles with clinical and commercial-stage biopharmaceutical companies. Previously, Mr. Claiborne was the Chief Financial Officer (CFO) and a board member of Indivior PLC, where he led the company's spin-off from its parent company, Reckitt Benckiser, to become an independent, publicly traded entity. Before Indivior, he served as CFO of Sucampo Pharmaceuticals, Inc., which was later sold to Mallinckrodt. He also held the role of CFO and Corporate Secretary at Osiris Therapeutics, Inc. during its initial public offering. Mr. Claiborne is also the founder and CEO of Prosperity Capital Management, LLC, a private investment and advisory firm.

Vinay Shah, Chief Financial Officer

Vinay Shah will assume the role of Chief Financial Officer for Adial Pharmaceuticals on November 16, 2024, bringing over 25 years of experience in the pharmaceutical, biopharmaceutical, and healthcare sectors. Most recently, he served as CFO at Virpax Pharmaceuticals, Inc., where his work included implementing fundraising and strategic initiatives. Prior to that, at Aravive, Inc., Mr. Shah was instrumental in raising over $150 million and played key roles in a significant reverse merger and out-licensing efforts in China. He also contributed to Pacira Pharmaceuticals, Inc.'s IPO by assisting with S-1 preparation, financial audits, and SEC compliance. His background also includes finance leadership positions at Cardinal Health, Inc. and Jostens Learning Corporation, and he began his career in auditing at KPMG Peat Marwick and Price Waterhouse Coopers.

Tony Goodman, Chief Operating Officer

Tony Goodman serves as the Chief Operating Officer of Adial Pharmaceuticals. While specific detailed background information on his past companies and sales was not extensively available in the provided search results, he is listed as a member of the management team.

Brigitte Robertson, MD, Acting Chief Medical Officer

Brigitte Robertson, MD, holds the position of Acting Chief Medical Officer at Adial Pharmaceuticals. Specific details about her past companies, sales, or private equity involvement were not provided in the search results.

William B. Stilley, Co-founder and CEO of Purnovate, Inc. (Adial Subsidiary)

William B. Stilley co-founded Adial Pharmaceuticals in December 2010 and served as its Chief Executive Officer. He is currently the Chief Executive Officer and Director of Purnovate, Inc., a wholly-owned subsidiary of Adial Pharmaceuticals, focusing on developing drugs for pain reduction and addiction treatment. Before Adial, he was the Vice President, Business Development & Strategic Projects at Clinical Data, Inc., where he was involved in licensing, M&A transactions, and managing Phase 3 clinical trials. Mr. Stilley also served as COO and CFO of Adenosine Therapeutics, LLC, where he managed internal operations and all financing activities until the sale of its principal assets to Clinical Data, Inc. He has advised both public and private companies on financing and M&A transactions and has served as interim CFO for a public company and COO and CFO for several private companies.

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The key risks to Adial Pharmaceuticals (ADIL) are primarily centered around its financial viability and the successful progression of its lead drug candidate.

1. Severe Liquidity Crisis and Need for Funding: Adial Pharmaceuticals faces a significant liquidity crisis, identified as the single biggest threat to its clinical trajectory. As of September 30, 2025, the company reported cash and cash equivalents of only $4.6 million, which is projected to fund operations only into the second quarter of 2026. Approximately $2 million is needed just for drug production to initiate the pivotal Phase 3 trial for AD04 in the first half of 2026. Without securing this capital, the entire clinical program for AD04, which represents the company's sole source of value, is at risk of stalling. The company primarily relies on equity funding, which carries a high risk of dilution for existing shareholders.
2. Clinical Trial Execution and Regulatory Approval Risk: Although Adial Pharmaceuticals has received positive feedback and clarity from the FDA regarding its proposed Phase 3 trial design for AD04, the successful execution of the trial remains a critical challenge. Addiction treatments often involve complex endpoint requirements, adding to the inherent difficulties of clinical development. Furthermore, the company faces general risks associated with obtaining regulatory approvals for the commercialization of its product candidates and complying with ongoing regulatory requirements. Past Phase 3 trial results for AD04 have shown mixed outcomes, failing to meet the primary goal in one instance, which underscores the significant uncertainties in drug development.
3. High Dependence on a Single Lead Product (AD04): As a clinical-stage biopharmaceutical company, Adial Pharmaceuticals' business and future prospects are almost entirely dependent on the successful development, regulatory approval, and eventual commercialization of its lead investigational drug candidate, AD04, for Alcohol Use Disorder (AUD). The company currently has no primary revenue stream from product sales. Any delays, failures in clinical trials, or inability to secure regulatory approval or market acceptance for AD04 would severely impact the company's financial condition and overall viability.

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Adial Pharmaceuticals' primary product is AD04, a genetically targeted therapeutic agent for the treatment of Alcohol Use Disorder (AUD). The addressable market for AUD treatment is projected to be approximately $0.79 billion globally in 2025. This market is anticipated to grow at a compound annual growth rate (CAGR) of 6.1% to reach $1.4 billion globally by 2035.

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Adial Pharmaceuticals (ADIL), a clinical-stage biopharmaceutical company, currently has no revenue, making its future growth entirely dependent on the successful development and commercialization of its pipeline. Over the next 2-3 years, the company's revenue growth is expected to be driven by the following key factors:

1. Successful Completion of Phase 3 Clinical Trials and Regulatory Approval of AD04 for Alcohol Use Disorder (AUD): Adial's primary revenue driver hinges on the advancement and ultimate approval of its lead drug candidate, AD04, for the treatment of Alcohol Use Disorder. The company has successfully completed a pharmacokinetics study (AD04-103) and received positive feedback from the FDA regarding its 505(b)(2) bridging strategy, positioning it to initiate a Phase 3 clinical trial in 2025. The successful outcome of this pivotal trial and subsequent regulatory clearance would allow Adial to commercialize AD04, generating its initial product revenue.

2. Commercialization and Adoption of the AD04 Companion Diagnostic Genetic Test: Adial is developing a companion diagnostic genetic test designed to identify patients with specific genetic markers who are most likely to respond to AD04. This precision medicine approach aims to optimize treatment outcomes and enhance AD04's market differentiation. A strategic partnership with Boudicca Dx supports the development plan for this diagnostic, and new patents strengthen the intellectual property around this genetic-based approach, which is crucial for targeted commercialization and could drive sales by ensuring the drug is administered to the most suitable patient population.

3. Expansion of AD04's Indications to Other Addiction and Related Disorders: Beyond AUD, Adial Pharmaceuticals is exploring the potential of AD04 to treat other addiction and related disorders. The company has secured new U.S. patents that broaden the coverage of its genetic-based approach, including genotype-specific treatment for opioid-related disorders. Further successful clinical development and regulatory approvals for additional indications, such as opioid use disorder, gambling, or obesity, would significantly expand the addressable market for AD04 and serve as a substantial driver of future revenue growth.

4. Strategic Partnerships and Licensing Agreements: Adial's forward guidance indicates ongoing discussions regarding partnerships to support the design of its pivotal Phase 3 trials. While direct product sales will be the primary revenue source post-approval, strategic collaborations could provide revenue through upfront payments, milestone achievements, and royalties. The company has already received a six-figure milestone payment from Adovate for an asthma compound, demonstrating its capacity to generate revenue from out-licensed assets or other collaborative agreements, which can bolster its financial position and indirectly support AD04's path to market.

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Share Issuance

• Adial Pharmaceuticals completed a $3.6 million public offering in June 2025.
• In August 2023, the company effected a 1-for-25 reverse stock split, which reduced its outstanding common shares from approximately 26.85 million in November 2022 to about 1.2 million immediately after the split. Following this, total outstanding shares increased to 21.83 million as of October 2025, indicating further issuances.
• The company has historically funded its operations through proceeds from initial and secondary public offerings, private placements, and equity lines.

Inbound Investments

• Adial Pharmaceuticals has funded its operations through private placements and equity lines.
• Institutional investors acquired a total of 85,232 shares, valued at approximately $86.08K, over the last 24 months.

Outbound Investments

• The company recognized a $0.6 million loss on an equity method investment for the fiscal year ended December 31, 2024.

Capital Expenditures

• Research and development (R&D) expenses significantly increased by approximately $1.9 million (155%) in 2024 compared to 2023.
• The primary focus of these increased R&D expenditures in 2024 included approximately $1.4 million for direct clinical trial expenses related to a pharmacokinetics (PK) study and about $813 thousand for chemistry, manufacturing, and controls (CMC) expenses to support drug product manufacturing for upcoming Phase 3 clinical programs.
• Adial Pharmaceuticals expects R&D expenses to continue increasing in the near term as it progresses with clinical trials for its lead product candidate.