Adial Pharmaceuticals Files 8-K Report

TL;DR

Adial Pharma filed an 8-K, likely with financial updates. Keep an eye out for details.

AI Summary

On September 16, 2025, ADIAL PHARMACEUTICALS, INC. filed an 8-K report. The filing primarily concerns financial statements and exhibits, along with other events and a Regulation FD disclosure. No specific financial figures or material events were detailed in the provided excerpt.

Why It Matters

This filing indicates Adial Pharmaceuticals is providing updates to the SEC, which could include important financial or operational information for investors.

Risk Assessment

Risk Level: low — The filing is a standard 8-K report without immediate disclosure of negative events or significant financial changes.

Key Players & Entities

• ADIAL PHARMACEUTICALS, INC. (company) — Registrant
• September 16, 2025 (date) — Date of Report
• Delaware (jurisdiction) — State of incorporation
• Glen Allen, VA (location) — Principal executive offices

FAQ

Filing Documents

• ea0257511-8k_adial.htm (8-K) — 38KB
• ea025751101ex99-1_adial.htm (EX-99.1) — 17KB
• ex99-1_001.jpg (GRAPHIC) — 4KB
• 0001213900-25-087925.txt ( ) — 230KB
• adil-20250916.xsd (EX-101.SCH) — 3KB
• adil-20250916_lab.xml (EX-101.LAB) — 33KB
• adil-20250916_pre.xml (EX-101.PRE) — 22KB
• ea0257511-8k_adial_htm.xml (XML) — 4KB

01. Regulation FD Disclosure

Item 7.01. Regulation FD Disclosure. On September 16, 2025, Adial Pharmaceuticals, Inc. (the "Company") issued a press release announcing that it had received the final meeting minutes from its End of Phase 2 (EOP2) Meeting with the U.S. Food and Drug Administration (FDA) held on July 29, 2025. The minutes provide the FDA's formal input into the AD04 Phase 3 adaptive clinical trial design and broader clinical development strategy. This positive feedback marks a key milestone in advancing AD04 toward registration. The objective for the EOP2 Meeting was to align with the FDA on the design of the Phase 3 clinical development program for AD04, the Company's lead investigational drug, a serotonin-3 receptor antagonist, being developed for the treatment of Alcohol Use Disorder (AUD) in individuals with heavy drinking and select genotypes. The discussion included key elements of the planned adaptive study design elements, such as target population, clinical endpoints, inclusion and exclusion criteria, dosing regimen, and affirmation of the biomarker-positive and biomarker-negative groups. Key Highlights from the FDA EOP2 Meeting: FDA recognized AUD as an unmet need. FDA supported the Company's protocol and proposed adaptive trial design core elements, including the defined biomarker-positive and biomarker-negative patients, key inclusion criteria targeting moderate to severe AUD, trial duration, primary endpoints, interim analysis sample size, and safety monitoring framework. FDA confirmed the proposed primary efficacy endpoints for AD04, specifically, zero heavy drinking days during months 5 and 6 of the efficacy observation period. FDA advised that key secondary endpoints intended for future product labeling should be pre-specified in the protocol for consideration. The FDA supported the Company's plan to account for homozygous populations and referenced guidance on developing targeted therapies for low-frequency molecular subsets, with implications for stud

01. Other Events

Item 8.01. Other Events. On September 16, 2025, the Company issued a press release announcing that it had received the final meeting minutes from its End of Phase 2 (EOP2) Meeting with the U.S. Food and Drug Administration (FDA) held on July 29, 2025. The minutes provide the FDA's formal input into the AD04 Phase 3 adaptive clinical trial design and broader clinical development strategy. This positive feedback marks a key milestone in advancing AD04 toward registration. The objective for the EOP2 Meeting was to align with the FDA on the design of the Phase 3 clinical development program for AD04, the Company's lead investigational drug, a serotonin-3 receptor antagonist, being developed for the treatment of Alcohol Use Disorder (AUD) in individuals with heavy drinking and select genotypes. The discussion included key elements of the planned adaptive study design elements, such as target population, clinical endpoints, inclusion and exclusion criteria, dosing regimen, and affirmation of the biomarker-positive and biomarker-negative groups. Key Highlights from the FDA EOP2 Meeting: FDA recognized AUD as an unmet need. FDA supported the Company's protocol and proposed adaptive trial design core elements, including the defined biomarker-positive and biomarker-negative patients, key inclusion criteria targeting moderate to severe AUD, trial duration, primary endpoints, interim analysis sample size, and safety monitoring framework. FDA confirmed the proposed primary efficacy endpoints for AD04, specifically, zero heavy drinking days during months 5 and 6 of the efficacy observation period. FDA advised that key secondary endpoints intended for future product labeling should be pre-specified in the protocol for consideration. The FDA supported the Company's plan to account for homozygous populations and referenced guidance on developing targeted therapies for low-frequency molecular subsets, with implications for study design and potential labeling of rare subg

01. Financial Statements and Exhibits

Item 9.01. Financial Statements and Exhibits. (d) Exhibits. Exhibit Number Description 99.1 Press Release issued by Adial Pharmaceuticals, Inc. on September 16, 2025 104 Cover Page Interactive Data File (embedded within the XBRL document) 3

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Dated: September 16, 2025 ADIAL PHARMACEUTICALS, INC. By: /s/ Cary J. Claiborne Name: Cary J. Claiborne Title: President and Chief Executive Officer 4

View Full Filing

View this 8-K filing on SEC EDGAR