Sep. 2 at 12:39 PM
$COYA
Item 8.01. Other Events.
On August 29, 2025, Coya Therapeutics Inc. (“Coya”) received a
$4.2 million milestone payment from its strategic partner, Dr. Reddy’s Laboratories
Ltd. (“DRL”), pursuant to a Development and License Agreement, dated December 5, 2023 (the “Agreement”), as a result of the U.S. Food and Drug
Administration’s (the “FDA”) acceptance of Coya’s 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-Week Study with Additional 24-Week Open Label Extension
(OLE) to Evaluate the Safety and Efficacy of COYA 302 for the Treatment of Amyotrophic Lateral Sclerosis (ALS)” (the “Phase 2 Study”). Pursuant to
the Agreement, Coya will also receive an additional
$4.2 million payment from DRL upon the dosing of the first patient in the Phase 2 Study.
