Coya Therapeutics, Inc.

https://coyatherapeutics.com/

Coya Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing proprietary therapies that enhance the function of regulatory T cells (Tregs). The company's mission is to address significant unmet medical needs in neurodegenerative, chronic inflammatory, autoimmune, and metabolic diseases. Coya Therapeutics is headquartered in Houston, Texas.

The company's pipeline utilizes multiple therapeutic modalities, including Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. Key investigational product candidates include COYA 302, a biologic combination currently in Phase 2 trials for amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD), with development also targeting Alzheimer's disease and Parkinson's disease. Other candidates in development include COYA 301, a low-dose interleukin 2 product, and COYA 303, a combination of COYA 301 and a GLP-1 receptor agonist, both aimed at inflammatory diseases. Additionally, the pipeline features exosome-based therapies like COYA 201 and COYA 206, and the autologous Treg cell therapy COYA 101.

In November 2024, Arun Swaminathan was appointed Chief Executive Officer, succeeding founder Dr. Howard Berman, who transitioned to Executive Chairman. Coya Therapeutics has recently received FDA acceptance for its Investigational New Drug (IND) application for COYA 302 for the treatment of frontotemporal dementia (FTD) in January 2026, and for ALS in August 2025. The company is actively enrolling and dosing patients in the ALSTARS Phase 2 trial for COYA 302 in ALS across the U.S. and Canada, with full enrollment targeted for the second half of 2026 and topline results anticipated in the first quarter of 2027. As of December 31, 2025, Coya Therapeutics reported $46.8 million in cash, providing a cash runway into the second half of 2027.

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