Material Event Form 8 K

Item 8.01 Other Events.

On June 14, 2024, Coya Therapeutics, Inc. (the "Company") submitted to the U.S. Food and Drug Administration (the "FDA") an Investigational New Drug Application (the "IND") seeking to initiate a 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 "Study"). On July 12, 2024, the Company received an email notification from the FDA stating that additional non-clinicaldata is required prior to the initiation of the Study. The FDA also stated that it would provide the Company with more details about what additional information it requires within the next thirty (30) days.