Adial Pharmaceuticals Inc SEC Filings

Adial Pharmaceuticals (ADIL) filed its Q3 2025 report, showing a net loss of $1.79 million for the quarter and $5.98 million for the nine months. Operating expenses fell as R&D declined to $521k (down ~50% year over year) while G&A was $1.24 million. Interest income was modest and losses from its Adovate equity method investment continued.

Cash and equivalents were $4.61 million at September 30, 2025. Year-to-date financing included roughly $2.2 million from a May warrant inducement and $3.0 million net from a June offering; the company also raised about $478k via its ATM in Q3. Management states cash is expected to fund operations into the second quarter of 2026, and the filing notes substantial doubt about continuing as a going concern absent additional capital.

Operationally, Adial received final FDA End of Phase 2 meeting minutes in September guiding the Phase 3 adaptive trial design for AD04 in alcohol use disorder. Common shares outstanding were 23,836,383 as of September 30, 2025; 23,987,587 as of November 7, 2025.

Adial Pharmaceuticals reported FDA feedback supporting its adaptive trial design for AD04 in alcohol use disorder (AUD). The FDA recognized AUD as an unmet need and agreed with core protocol elements including biomarker-defined positive and negative cohorts, inclusion criteria targeting moderate-to-severe AUD, trial duration, interim analysis sample size, and safety monitoring. The agency confirmed the primary efficacy endpoint of zero heavy drinking days during months 5 and 6 of the efficacy observation period and advised pre-specifying key secondary endpoints for labeling consideration. FDA also reviewed the planned interim analyses, the Statistical Analysis Plan, and the Data Monitoring Committee structure, stressing alignment among protocol, simulation report, and SAP to ensure proper alpha control and reduce post-trial analysis risk.

Adial Pharmaceuticals, Inc. filed a Form S-8 registering shares for its employee benefit plans and incorporates prior registration statements and corporate documents by reference. The filing references prior S-8 registrations that, after the 1-for-25 reverse stock split, correspond to registered blocks of 70,000, 80,000 and other shares, and notes an additional 1,500,000 shares registered on December 12, 2024. The filing lists governing documents, equity plan amendments, legal opinions, auditor consents and officers and directors who signed the registration statement.

Adial Pharmaceuticals (ADIL) is a clinical-stage biopharmaceutical company developing AD04 for alcohol use disorder with a precision‑medicine genetic focus. At June 30, 2025 the company held $5.9 million in cash and cash equivalents and reported a $4.19 million net loss for the six months ended June 30, 2025, leaving an accumulated deficit of $86.2 million.

Management received approximately $5.3 million of net proceeds from warrant exercises and equity issuances in May–June 2025 and completed a June 2025 best efforts offering that generated about $3.0 million net. The company states these funds are sufficient to meet current commitments into the second quarter of 2026 but explicitly notes substantial doubt about its ability to continue as a going concern and that additional capital will be required for planned Phase 3 trials.

Key operational positives disclosed include a favorable FDA response on an in‑vitro bridging strategy and an issued U.S. patent (April 15, 2025) covering AD04 administration for patients with specified genetic markers. The filing also discloses material weaknesses in internal controls and multiple warrant programs and shareholder approvals that create meaningful potential dilution.