Welcome to our dedicated page for ADIAL PHARMACEUTICALS SEC filings (Ticker: ADIL), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
Adial Pharmaceuticals filings document the regulatory record of a Nasdaq-listed, clinical-stage biopharmaceutical company developing AD04 for alcohol use disorder and related addiction indications. Its Form 8-K filings include financial-result releases, Regulation FD disclosures on AD04 commercialization frameworks, Nasdaq compliance notices, certificate and securityholder-rights matters, and governance updates.
Proxy and governance filings describe stockholder voting matters, including warrant-related share issuance approvals under Nasdaq rules, board matters, and equity-incentive compensation. The filing record also covers restricted stock awards, director changes, private-placement warrant mechanics, common stock capital structure, and public-company disclosure controls relevant to Adial’s development-stage operating model.
Claiborne Cary J reported acquisition or exercise transactions in this Form 4 filing.
Adial Pharmaceuticals Chief Executive Officer Claiborne J. Cary received a grant of 37,985 restricted shares of common stock. The award carries a grant price of $0.00 per share, indicating it is compensation rather than an open-market purchase.
The restricted shares vest in full on the earlier of the one-year anniversary of the grant date or a Change of Control, as defined in Adial’s 2017 Equity Incentive Plan, subject to his continued service through the vesting date. Following this grant, Cary directly holds 40,417 shares of Adial common stock.
Adial Pharmaceuticals reported its 2025 fiscal year results and gave a broad business update centered on its lead addiction therapy candidate, AD04. The company highlighted positive pharmacokinetic data from study AD04-103, a productive End-of-Phase 2 FDA meeting, and supportive FDA feedback on its in vitro bridging strategy, all backing plans for a rigorous Phase 3 program.
Adial cited evolving U.S. policy discussions that may allow a single pivotal trial plus confirmatory evidence for approval in some cases, which it believes could lower Phase 3 costs and shorten timelines for AD04. The company also outlined a collaboration framework with Molteni Farmaceutici for exclusive commercialization of AD04 in Europe, with an anticipated definitive agreement including upfront and milestone payments and royalties, and total potential value estimated at nearly $60 million if AD04 successfully launches.
Additional updates included regaining compliance with Nasdaq’s minimum bid price requirement, publication of an international patent application that is expected to extend AD04 protection through at least 2045 once granted, and a six-figure milestone payment from Adovate tied to a Phase 1 asthma trial. Adial describes itself as a clinical-stage company developing genetically targeted treatments for Alcohol Use Disorder and other addictions.
Adial Pharmaceuticals, Inc. is a clinical-stage biopharma focused on AD04, a low-dose ondansetron-based therapy for alcohol use disorder in genetically defined patients, supported by a companion diagnostic test. AD04 showed statistically significant benefits in a pre-specified heavy-drinking subgroup in the ONWARD Phase 3 trial, with a safety profile similar to placebo.
The company reported net losses of about $8.0 million in 2025 and had an accumulated deficit of about $90.0 million, and its current cash is not expected to fund operations for twelve months from this report’s filing date. Adial is planning an adaptive Phase 3 program aligned with FDA feedback and executed a non-binding collaboration framework with Molteni Farmaceutici for potential AD04 commercialization in Europe, with an estimated long-term milestone and royalty opportunity of nearly $60 million, though no payments are assured.
Adial Pharmaceuticals entered a collaboration framework agreement with Molteni Farmaceutici for a proposed exclusive partnership to commercialize AD04 in Europe, while also updating shareholders on a special meeting that could not be convened due to lack of quorum.
The framework, subject to a final definitive agreement, outlines clinical, regulatory, manufacturing, and commercial terms and gives Molteni an exclusivity period to assess a European launch of AD04. A future definitive agreement is expected to include an upfront payment, development and commercial milestones, and tiered royalties ranging from high single digits to low double digits on European AD04 net sales, with total potential milestones and royalties estimated at nearly $60 million if AD04 advances and launches successfully.
Separately, the special meeting of stockholders called to approve the issuance of up to 13,823,512 shares upon exercise of New Warrants under a November 25, 2025 inducement agreement could not be held because a quorum was not present. Under that agreement, Adial must call additional stockholder meetings every 90 days until approval is obtained or the New Warrants are no longer outstanding.
Adial Pharmaceuticals announced that it has regained full compliance with Nasdaq’s minimum bid price requirement. Nasdaq confirmed that for 10 consecutive business days, from February 6 through February 20, 2026, Adial’s common stock closed at $1.00 per share or higher, and the compliance matter is now closed.
The company highlights this as an important milestone as it advances its lead drug candidate AD04 toward a pivotal Phase 3 program for Alcohol Use Disorder and continues advanced strategic partnering discussions to support further development and potential commercialization.
ADIAL PHARMACEUTICALS ownership disclosure: Armistice Capital, LLC and Steven Boyd report beneficial ownership of 2,799,643 shares, representing 9.99% of common stock as of 12/31/2025. Armistice is the investment manager of Armistice Capital Master Fund Ltd., the direct holder; the Master Fund is listed as having the right to receive dividends or sale proceeds. The filing states voting and dispositive power over the shares is held jointly (shared power: 2,799,643), and the share counts are based on information from the issuer.
Adial Pharmaceuticals, Inc. is implementing a 1-for-25 reverse stock split of its common stock, reducing outstanding shares from approximately 27.8 million to approximately 1.1 million. The amendment to the Certificate of Incorporation becomes legally effective at 11:59 p.m. Eastern Time on February 5, 2026.
The common stock will begin trading on a split-adjusted basis on the Nasdaq Capital Market on February 6, 2026, continuing under the symbol “ADIL”, with a new CUSIP of 00688A304. Fractional shares will not be issued; instead, stockholders will receive a cash payment based on the average closing price over the ten trading days before the effective time.
The company states that the primary purpose of the reverse split is to raise the per-share trading price to support continued listing on the Nasdaq Capital Market, which requires a minimum bid price of at least $1.00 per share, while noting there is no assurance the split will achieve this for the required period.
Adial Pharmaceuticals, Inc. reported that on January 5, 2025, board member James W. Newman, Jr. resigned from the company’s Board of Directors, effective immediately. He had been serving as a non-employee director and was also a member of both the Audit Committee and the Compensation Committee.
The company states that Mr. Newman did not report any disagreement with Adial on matters related to its operations, policies, or practices in connection with his resignation. The report is signed on behalf of Adial Pharmaceuticals by President and Chief Executive Officer Cary J. Claiborne.
Adial Pharmaceuticals is asking stockholders to approve the issuance of up to 13,823,512 shares of common stock upon the exercise of its Series F warrants. These warrants were granted to an institutional investor in a November 2025 warrant inducement deal, where the investor exercised earlier Series C-1 and Series E warrants for 9,215,675 shares at $0.31 per share, providing about $2.86 million in gross proceeds. If stockholders approve the warrant exercise proposal and all Series F warrants are exercised for cash at $0.31, Adial could receive up to approximately $4.3 million in additional gross proceeds. The company notes that this could significantly dilute existing holders if all shares are issued and may weigh on the stock price when sold into the market. A second proposal would allow the Board to adjourn the special meeting to solicit more votes if needed.