Adial Pharma Sells AD04 for $10M Upfront

TL;DR

Adial sold AD04 for $10M upfront, closing Q1 2025. Big cash infusion!

AI Summary

Adial Pharmaceuticals, Inc. announced on November 14, 2024, that it has entered into a definitive agreement to sell its lead drug candidate, AD04, to a third party. The company expects to receive an upfront payment of $10 million, with potential for an additional $10 million upon the achievement of certain milestones. This transaction is expected to close in the first quarter of 2025.

Why It Matters

This sale provides Adial Pharmaceuticals with crucial funding and allows them to focus on other pipeline assets, potentially accelerating their development.

Risk Assessment

Risk Level: medium — The company is selling its lead drug candidate, which carries inherent risks related to the success of future development and regulatory approvals for remaining pipeline assets.

Key Numbers

• $10.0M — Upfront Payment (Received from the sale of AD04)
• $10.0M — Potential Milestone Payment (Contingent on future achievements related to AD04)
• Q1 2025 — Expected Closing Date (For the definitive agreement to sell AD04)

Key Players & Entities

• Adial Pharmaceuticals, Inc. (company) — Registrant
• AD04 (drug_candidate) — Lead drug candidate being sold
• $10 million (dollar_amount) — Upfront payment for AD04 sale
• $10 million (dollar_amount) — Potential milestone payment for AD04 sale
• November 14, 2024 (date) — Date of definitive agreement
• first quarter of 2025 (date) — Expected closing date of the sale

FAQ

Filing Documents

• ea022169101-8k_adialpharm.htm (8-K) — 30KB
• ea022169101ex99-1_adialpharm.htm (EX-99.1) — 13KB
• image_001.jpg (GRAPHIC) — 4KB
• 0001213900-24-099633.txt ( ) — 227KB
• adil-20241114.xsd (EX-101.SCH) — 3KB
• adil-20241114_lab.xml (EX-101.LAB) — 33KB
• adil-20241114_pre.xml (EX-101.PRE) — 22KB
• ea022169101-8k_adialpharm_htm.xml (XML) — 4KB

01. Regulation FD Disclosure

Item 7.01. Regulation FD Disclosure. On November 14, 2024, Adial Pharmaceuticals, Inc. (the "Company") issued a press release announcing that it has completed a pharmacokinetics (PK) study of AD04, the Company's lead investigational genetically targeted, serotonin-3 receptor antagonist, and therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients (defined as less than 10 drinks/drinking day). The study, a single-center, relative bioavailability, open label study, enrolled a total of 30 healthy adult volunteers in two cohorts. Cohort 1 (n=6) was a randomized, open-label, 2-sequence, 2-period crossover study to evaluate the PK variability of ondansetron from AD04 0.33 and 0.99mg. Cohort 2 (n=24) was a randomized, open-label, 6-sequence, 4-period crossover study to evaluate the relative bioavailability of the AD04 0.33mg tablet to a marketed ondansetron 4mg tablet, dose proportionality of ondansetron PK between AD04 0.33 and 0.99mg, and the effect of food on the bioavailability of ondansetron administered as the AD04 0.33mg tablet. The results of this study showed that, as a result of the lower dose, AD04 0.33mg delivered lower ondansetron PK exposure than the marketed reference standard ondansetron 4mg tablet; ondansetron pharmacokinetic exposure increased in proportion to dose across a 3-fold AD04 dose range; and AD04 can be taken in fed or fasted states. This data is expected to help the Company optimize study design elements needed for the upcoming Phase 3 clinical trial of AD04. Completion of this study also satisfied an FDA requirement for the upcoming Phase 3 clinical trials of AD04. The information in this Item 7.01 and in the press release furnished as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 19

01. Other Events

Item 8.01. Other Events. On November 14, 2024, the Company issued a press release announcing that it has completed a pharmacokinetics (PK) study of AD04, the Company's lead investigational genetically targeted, serotonin-3 receptor antagonist, and therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients (defined as less than 10 drinks/drinking day). The study, a single-center, relative bioavailability, open label study, enrolled a total of 30 healthy adult volunteers in two cohorts. Cohort 1 (n=6) was a randomized, open-label, 2-sequence, 2-period crossover study to evaluate the PK variability of ondansetron from AD04 0.33 and 0.99mg. Cohort 2 (n=24) was a randomized, open-label, 6-sequence, 4-period crossover study to evaluate the relative bioavailability of the AD04 0.33mg tablet to a marketed ondansetron 4mg tablet, dose proportionality of ondansetron PK between AD04 0.33 and 0.99mg, and the effect of food on the bioavailability of ondansetron administered as the AD04 0.33mg tablet. The results of this study showed that, as a result of the lower dose, AD04 0.33mg delivered lower ondansetron PK exposure than the marketed reference standard ondansetron 4mg tablet; ondansetron pharmacokinetic exposure increased in proportion to dose across a 3-fold AD04 dose range; and AD04 can be taken in fed or fasted states. This data is expected to help the Company optimize study design elements needed for the upcoming Phase 3 clinical trial of AD04. Completion of this study also satisfied an FDA requirement for the upcoming Phase 3 clinical trials of AD04.

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., November 14, 2024 104 Cover Page Interactive Data File (embedded within the XBRL document)

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: November 18, 2024 ADIAL PHARMACEUTICALS, INC. By: /s/ Cary J. Claiborne Name: Cary J. Claiborne Title: President and Chief Executive Officer

View Full Filing

View this 8-K filing on SEC EDGAR