ADIAL PHARMACEUTICALS, INC.

Adial Pharmaceuticals anticipates significant leadership changes, including the termination of current President and CEO Cary Claiborne and CFO Vinay Shah, contingent on stockholder approval at the upcoming 2026 Annual Meeting. Matthew Davidson is expected to become the new President and CEO, and a new CFO will be appointed. Additionally, changes to the Board of Directors are expected. The company also announced its 2026 Annual Meeting will be held on September 17, 2026, and revised deadlines for stockholder proposals to August 23, 2026.

Adial Pharmaceuticals, Inc. has acquired Azora Therapeutics, Inc. in a merger transaction. The acquisition is supported by a concurrent private placement of up to $64 million, with $32 million upfront and an additional $32 million contingent on milestones. The combined company will advance Azora's lead asset, AT177, a colon-targeted aryl hydrocarbon receptor (AhR) agonist for ulcerative colitis. The transaction also includes the appointment of Wendy Young, Ph.D. to Adial's Board of Directors.

Adial Pharmaceuticals, Inc. announced the acquisition of Azora Therapeutics, Inc., a biopharmaceutical company focused on inflammatory diseases. This acquisition brings Azora's lead asset, AT177, a colon-targeted AhR agonist for ulcerative colitis, into Adial's pipeline. Concurrent with the acquisition, Adial secured an initial $32 million in a private placement, with the potential for an additional $32 million upon Phase 1 clinical study initiation, to fund AT177's development through key clinical milestones. Additionally, Wendy Young, Ph.D., was appointed to Adial's Board of Directors.

Adial Pharmaceuticals reported a net loss of $2.0 million for Q1 2026, an improvement from $2.2 million in Q1 2025, driven by lower R&D expenses. The company ended the quarter with $4.6 million in cash, sufficient to fund operations into the second half of 2026. Strategically, Adial is advancing its AD04 program, benefiting from evolving FDA policies that could streamline drug approval and growing support for patient-centered endpoints in Alcohol Use Disorder. The company also established a collaboration framework with Molteni Farmaceutici for European commercialization and strengthened its intellectual property, while actively seeking additional funding.

Adial Pharmaceuticals reported a net loss of $2.02 million for the first quarter of 2026, an improvement compared to $2.23 million in the same period last year. The company's cash and cash equivalents stood at $4.58 million as of March 31, 2026, but management noted that existing cash is insufficient to fund operations for the next twelve months, raising substantial doubt about its ability to continue as a going concern. A collaboration framework agreement was established with Molteni Farmaceutici for the commercialization of AD04 in Europe, potentially valued at nearly $60 million in royalties and milestones. Additionally, the company raised approximately $315,000 through its At-the-Market (ATM) offering in Q1 2026, with an additional $782,000 raised post-period.

Adial Pharmaceuticals, Inc. announced the filing of a new U.S. utility patent application for AD04, its lead investigational therapeutic agent for Alcohol Use Disorder (AUD). If granted, the patent is expected to protect the company's core assets through at least 2045. The application includes a Request for Track One Prioritized examination to expedite the process, aiming to strengthen and extend the long-term value of its intellectual property portfolio and enhance strategic positioning for commercialization and licensing discussions.

Adial Pharmaceuticals submitted its AD04 product application for the FDA Commissioner's National Priority Voucher Pilot Program (CNPV). This program, announced in 2025, aims to accelerate FDA review for drugs addressing national health priorities, potentially reducing review timelines from 10-12 months to 1-2 months. The company believes this strategic move could significantly expedite AD04's potential approval and market availability for Alcohol Use Disorder patients.

Adial Pharmaceuticals announced the successful completion of the demonstration batch production for AD04, its lead investigational drug for Alcohol Use Disorder. This milestone confirms the manufacturing process meets targeted specifications for the planned Phase 3 clinical program and matches the dissolution profile of the previous Phase 2 batch. The successful technical transfer to a new CDMO enables the production of clinical and registration batches, which are essential for conducting the upcoming clinical trial and updating the Investigational New Drug (IND) application with the FDA.

Adial Pharmaceuticals' Compensation Committee and Board of Directors approved significant equity awards on April 7, 2026, distributing a total of 100,190 Restricted Stock Awards (RSAs) and options for 9,185 shares of common stock. These awards, granted under the 2017 Equity Incentive Plan, aim to incentivize key management and independent directors. The RSAs and options vest fully on the one-year anniversary of the grant date or upon a Change of Control, aligning leadership's interests with long-term shareholder value.