Regulation FD Disclosure (Form 8-K)

Item 8.01. Regulation FD Disclosure.

As previously disclosed, on June 30, 2025, Coya Therapeutics Inc. ("Coya") submitted additional non-clinical data to support the initiation of its Investigational New Drug Application (the "IND") for the initiation of a planned clinical study entitled "Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, 24-WeekStudy with Additional 24-WeekOpen Label Extension (OLE) to Evaluate the Safety and Efficacy of COYA 302 for the Treatment of Amyotrophic Lateral Sclerosis (ALS)" (the "Phase 2 Study") to the U.S. Food and Drug Administration (the "FDA").

On July 29, 2025, the FDA informed Coya that due to the FDA's present workload and lack of resources, they are unable to meet its initial review goal date for the IND of July 30, 2025. The FDA also informed Coya that they will provide their decision on approval of the IND as soon as possible, and expect that it will be provided no later than August 29, 2025.