ADIL — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-14

• We are a clinical-stage biopharmaceutical company focused on developing treatments for serious inflammatory diseases, and the development of therapeutics for the treatment or prevention of addiction and related disorders. On June 11, 2026, we completed our previously announced acquisition of Azora T…

• Azora has historically focused on developing aryl hydrocarbon (“AhR”) receptor agonists to treat autoimmune diseases including ulcerative colitis. Following the Merger, our focus has shifted to the treatment of serious inflammatory diseases and our lead program is AT177 being studied for the treatme…

• Prior to the Merger, we were primarily focused on the development of AD04, a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (“AUD”) in heavy drinking patients. Historically, we have devoted the vast majority of our resources to deve…

• On June 11, 2026, we acquired Azora in accordance with the terms of the Merger Agreement. Pursuant to the Merger Agreement, Azora became a wholly owned subsidiary of the Company.

• At closing of the Merger, we issued to former Azora stockholders 437,421 shares of our common stock and 12,930.617 shares of Series A Non-Voting Convertible Preferred Stock, par value $0.001 per share (“Series A Preferred Stock”). Each share of Series A Preferred Stock is convertible into 1,000 shar…

Text removed vs the prior filing · source: 10-Q · 2026-05-08

• We are a clinical-stage biopharmaceutical company focused on the development of therapeutics for the treatment or prevention of addiction and related disorders. Our investigational new drug candidate, AD04, is being developed as a therapeutic agent for the treatment of alcohol use disorder (“AUD”). …

• We have devoted the vast majority of our resources to development efforts relating to AD04, including preparation for and conducting clinical trials, providing general and administrative support for these operations and protecting our intellectual property. We expect these activities to continue to …

• On March 3, 2026, we entered into a collaboration framework agreement with a strategic partner, Molteni Farmaceutici (“Molteni”), for a proposed exclusive partnership covering the commercialization of AD04 in Europe. The collaboration framework, which is subject to execution of a final definitive ag…

• The definitive agreement is expected to include an upfront payment, milestone payments tied to development and commercial progress, and tiered royalties on European AD04 net sales, payable to us. We believe the total potential aggregate value from royalties and milestones over time will be significa…

• The clinical development plan for AD04 is based on the regulatory feedback received in the meetings that took place in the third quarter of 2025. Our current planning assumption is to conduct one Phase 3 trial with an adaptive enrichment trial design, one subsequent confirmatory Phase 3 trial and on…

Text added vs the prior filing · source: 10-Q · 2026-08-14

• During the preparation of our financial statements for the second quarter of 2026, management identified a material weakness in internal control over financial reporting related to the accounting and financial reporting of the non-routine, complex transactions associated with the Merger, Financing, …

• Due to the material weakness in internal control over financial reporting as described above, our Chief Executive Officer and our Chief Financial Officer concluded that based on their evaluation of our disclosure controls and procedures, as of the end of the period covered by this report, our disclo…

• Notwithstanding the material weakness described above, our management, including the Chief Executive Officer and Chief Financial Officer, has concluded that unaudited condensed consolidated financial statements, and other financial information included in this quarterly report, fairly present in all…

• Management will take steps to remediate the weakness described above. Management will engage third-party accounting consulting firms to assist us in the review of our application and accounting for complex financial instruments.

• On June 11, 2026, we completed our acquisition of Azora, as further described in Note 4 to the unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. In connection with the acquisition, we have begun the process of integrating Azora’s financia…

Text removed vs the prior filing · source: 10-Q · 2026-05-08

• There has been no change in our internal control over financial reporting during the three months ended March 31, 2026 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Text added vs the prior filing · source: 10-Q · 2026-08-14

• In accordance with disclosures included in that Current Report on Form 8-K filed by the Company with the SEC on June 11, 2026 (the “Prior 8-K”), the employment of Tony Goodman, our Chief Operating Officer, was terminated effective August 11, 2026. In connection therewith, on August 11, 2026, the Com…

• The foregoing description of the Goodman Release does not purport to be complete and is qualified by reference to the full text of the Goodman Release, a copy of which is attached to this Quarterly Report on Form 10-Q as Exhibit 10.12 and incorporated herein by reference.

• As previously disclosed in the Prior 8-K, subject to certain exceptions, the Purchase Agreement prohibits the Company from issuing, without prior consent from the holders of the majority of the then outstanding Initial Closing Pre-Funded Warrants, shares of common stock or common stock equivalents d…

• The foregoing description of the Purchase Agreement Amendment does not purport to be complete and is qualified by reference to the full text of the Purchase Agreement Amendment, a copy of which is attached to this Quarterly Report on Form 10-Q as Exhibit 10.13 and incorporated herein by reference.