Adial Pharmaceuticals Q2 2024 Financial Results and Business Update

Adial Pharmaceuticals, Inc. (NASDAQ: ADIL), a clinical-stage biopharmaceutical company specializing in addiction treatment therapies, has issued a business update and financial results for the second quarter of 2024. Cary Claiborne, President and CEO of Adial, highlighted significant progress in developing AD04, their main investigational drug for treating Alcohol Use Disorder (AUD). A pharmacokinetics study for AD04 was initiated in June, with the final patient completing dosing in August. The study will produce key data by the fourth quarter of 2024, fulfilling FDA guidance requirements and informing the Phase 3 clinical trial design for AD04. Success in this study could enhance ongoing discussions with potential partners.

The pharmacokinetics study enrolled 30 healthy adults in an open-label format to compare AD04's pharmacokinetic profile when taken orally at 0.33 mg, with and without food, against a reference product. Additionally, Adial has teamed up with Boudicca Dx, a precision medicine testing accelerator, to develop a companion diagnostic genetic test (CDx) that aligns with FDA guidelines. Input from the FDA regarding the CDx plan is expected to bolster the clinical success of the Phase 3 trial.

Adial has also been active in intellectual property development and scholarly publications. On July 31, 2024, the company filed a new patent application to protect core technologies until 2044. Publications in peer-reviewed journals on June 20 and April 10, 2024, supported AD04's potential efficacy and safety. The June publication indicated significant differences in heavy drinking days between AD04 and placebo groups in patients with specific genotypic variants. The April article highlighted AD04’s promising clinical results, safety profile, and compliance, alongside a study on its liver safety compared to a placebo in prior Phase 3 trials.

Financially, Adial reported cash and cash equivalents of $3.3 million as of June 30, 2024, up from $2.8 million at the end of 2023. The company also raised $3.8 million through its at-the-market facility after the quarter ended, which extends funding into the second half of 2025, based on current plans. Research and development expenses rose by $583,000, primarily due to ongoing clinical trial costs and drug product provision. General and administrative expenses increased by $228,000 due to the absence of one-time gains from the previous year. The net loss for the three months ending June 30, 2024, was $2.5 million, compared to a net income of $1.1 million for the same period in 2023. This shift was driven by the absence of a $2.6 million gain from the Purnovate sale in the previous year and increased operational expenses.

Adial Pharmaceuticals continues to focus on developing AD04, a serotonin-3 receptor antagonist, as a treatment for AUD in patients with certain genetic markers, shown to reduce heavy drinking without significant safety concerns. The company is also exploring AD04's potential for treating other addictive disorders, including opioid use disorder, gambling, and obesity.

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