- Adial Pharmaceuticals announced the **successful analytical validation** of a **cheek swab collection method** for its AD04 therapy, developed in partnership with Genomind, to identify patients for the upcoming Phase 3 program and future commercial use.  **[1513525_a60b8e3eeb70409ea912ad3f8f5dfdf2_0]** 
- The **FDA confirmed** that the use of this genetic test in the Phase 3 study is a **Non-Significant Risk** (NSR), meaning an Investigational Device Exemption (IDE) application is not required.  **[1513525_a60b8e3eeb70409ea912ad3f8f5dfdf2_1]** 
- This milestone advances AD04 towards **FDA registration** and supports future commercial activities, with a new patent filing expected to extend market exclusivity to **2045**.  **[1513525_a60b8e3eeb70409ea912ad3f8f5dfdf2_0]** **[1513525_a60b8e3eeb70409ea912ad3f8f5dfdf2_1]**

Adial Pharmaceuticals Completes Validation of AD04 Genetic Test with Genomind

- Adial Pharmaceuticals, Inc. (ADIL) announced on **September 16, 2025**, that it received **favorable final meeting minutes** from its End of Phase 2 (EOP2) Meeting with the FDA, providing formal input and alignment on the **Phase 3 clinical development program for AD04**.  **[1513525_0001213900-25-087925_ea025751101ex99-1_adial.htm:0]** **[1513525_0001213900-25-087925_ea0257511-8k_adial.htm:1]** **[1513525_0001213900-25-087925_ea0257511-8k_adial.htm:2]** 
- The FDA supported the proposed adaptive trial design for AD04, a drug for **Alcohol Use Disorder (AUD)**, and confirmed **zero heavy drinking days during months 5 and 6** as the primary efficacy endpoint.  **[1513525_0001213900-25-087925_ea025751101ex99-1_adial.htm:0]** **[1513525_0001213900-25-087925_ea0257511-8k_adial.htm:1]** **[1513525_0001213900-25-087925_ea0257511-8k_adial.htm:2]** 
- This positive feedback is considered a **key milestone** for advancing AD04 toward registration and is expected to **accelerate strategic partnership discussions**.  **[1513525_0001213900-25-087925_ea025751101ex99-1_adial.htm:0]** **[1513525_0001213900-25-087925_ea025751101ex99-1_adial.htm:1]** 
- A new patent filing for AD04 could potentially **extend market exclusivity to 2045**.  **[1513525_0001213900-25-087925_ea025751101ex99-1_adial.htm:1]**

Adial Pharmaceuticals receives favorable FDA feedback for AD04 Phase 3 trial design

- Adial Pharmaceuticals, Inc. (ADIL) has been granted a **180-calendar day extension** by Nasdaq to regain compliance with the minimum $1.00 bid price requirement.  **[1513525_0001213900-25-083719_ea025574101ex99-1_adial.htm:0]** **[1513525_0001213900-25-083719_ea0255741-8k_adial.htm:1]** 
- The new deadline for the company to meet the Nasdaq Listing Rule 5550(a)(2) is **March 2, 2026**.  **[1513525_0001213900-25-083719_ea025574101ex99-1_adial.htm:0]** **[1513525_0001213900-25-083719_ea0255741-8k_adial.htm:1]** 
- To regain compliance, the company's common stock must maintain a closing bid price of at least **$1.00 per share for a minimum of ten (10) consecutive business days**.  **[1513525_0001213900-25-083719_ea025574101ex99-1_adial.htm:0]** 
- This extension has **no immediate effect** on the listing or trading of the company's shares on the Nasdaq Capital Market.  **[1513525_0001213900-25-083719_ea025574101ex99-1_adial.htm:0]** **[1513525_0001213900-25-083719_ea0255741-8k_adial.htm:1]** 
- The company intends to monitor its stock price and may consider a **reverse stock split** to cure the deficiency.  **[1513525_0001213900-25-083719_ea025574101ex99-1_adial.htm:0]** **[1513525_0001213900-25-083719_ea0255741-8k_adial.htm:1]**

ADIAL PHARMACEUTICALS (ADIL)