$5.600
-0.088 (-1.58%)At close
ADIL News
ADIL Events
Selling Stockholders Plan to Sell 25.15M Shares of Common Stock
This filing relates to the offer and sale from time to time by the selling stockholders of up to 25.15M shares of common stock. The company is not selling any shares under this prospectus and will not receive any of the proceeds from the sale of shares by the selling stockholders.
Adial Pharmaceuticals Acquires Azora Therapeutics and Raises $64M
Adial Pharmaceuticals has acquired Azora Therapeutics, a biopharmaceutical company developing treatments for serious inflammatory diseases. The acquisition brings Azora's lead asset AT177, a proprietary colon-targeted aryl hydrocarbon receptor agonist designed to enable localized activation with limited systemic exposure, into Adial's pipeline. Concurrent with the acquisition, Adial entered into a definitive agreement for a concurrent private placement of up to $64M in gross proceeds to Adial, before deducting placement agent and other offering expenses. The private placement is composed of an initial upfront financing of approximately $32M in gross proceeds in exchange for pre-funded warrants to purchase 11,780,948 shares of Adial's common stock, representing a purchase price of $2.7489 for each pre-funded warrant sold at the initial closing and the potential for up to an additional $32 million in gross proceeds upon Phase 1 clinical study initiation in exchange for pre-funded warrants to purchase up to 11,780,948 shares of common stock and common warrants to purchase up to 11,780,948 shares of common stock at a combined purchase price of $2.7489 for each pre-funded warrant and accompanying common warrant sold at milestone closings. The financing was led by Coastlands Capital with participation from Boxer Capital Management, Stonepine Capital Management, AuGC BioFund and other biotech specialists and institutional investors along with insiders and management. The combined company expects to use the proceeds from the private placement primarily to advance Azora's AT177 lead colon-targeted AhR program through key clinical milestones, including IND-enabling studies and the Phase 1a and Phase 1b studies in ulcerative colitis
Adial Pharmaceuticals Submits AD04 Application for FDA Priority Program
Adial Pharmaceuticals announced the submission of the AD04 product application for consideration of the FDA Commissioner's National Priority Voucher Pilot Program. Announced in 2025, the CNPV program is designed to speed up the FDA review process for drugs that address one of five key U.S. national health priorities. It uses a collaborative review approach-similar to a "tumor board," where experts meet to discuss cases-to help evaluate applications more efficiently.
Adial Pharmaceuticals Completes AD04 Demonstration Batch Production
Adial Pharmaceuticals announced completion of the demonstration batch production for AD04. The results of the batch confirmed that the transferred process met the targeted specifications for the planned Phase 3 clinical batch and matched the dissolution profile of the previous Phase 2 batch, thereby demonstrating a technical process transfer. This important step was required prior to manufacturing the batch production for the planned Phase 3 clinical program. The tech transfer of the manufacturing and analytical capability for AD04 to a new CDMO resulted in significant efficiencies and crossing the hurdle of dissolution, blend and content uniformity which will have a meaningful clinical and commercial impact for AD04, once approved for patients suffering from AUD. This achievement enables the production of the clinical and registration batches which are required to conduct the clinical trial as well as the needed data for updates to the IND for AD04 with the Food and Drug Administration.
Adial Pharmaceuticals Cash and Cash Equivalents Reach $5.9 Million
Cash and cash equivalents were $5.9 million as of December 31, 2025, compared to $3.8 million as of December 31, 2024. The Company believes that its existing cash and cash equivalents will fund its operating expenses into the second half of 2026 based on currently committed development plans. "2025 was a pivotal year for Adial as we continued to advance AD04 scientifically, strategically, and within an evolving regulatory landscape," said Cary Claiborne, Chief Executive Officer of Adial Pharmaceuticals. "Our positive AD04-103 pharmacokinetic results, productive End-of-Phase 2 meeting with the FDA, and supportive FDA feedback on our in vitro bridging strategy provided meaningful validation of our clinical and regulatory approach. Engaging Cytel for advanced statistical design and partnering with Genomind for precision medicine testing further strengthens our ability to execute a rigorous and clinically relevant Phase 3 program."
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