Coya Therapeutics Inc Dossier
Qualitative Analysis
Business overview
Coya Therapeutics, Inc. (NASDAQ: COYA) is a clinical-stage biotechnology company headquartered in Houston, Texas, focused on developing proprietary treatments that target the biology of regulatory T cells (Tregs). The company's therapeutic platforms leverage multiple modalities—including Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapies—to address systemic inflammation and neuroinflammation. Dysfunctional Tregs are a key driver of numerous high-unmet-need conditions, and Coya's pipeline is primarily focused on neurodegenerative, chronic inflammatory, autoimmune, and metabolic diseases.
Research as of 19 Jun 2026
Strategic Initiatives
Growth programs, investments, and their expected impact
Focusing clinical development efforts on the execution of the ALSTARS trial, a randomized, double-blind, placebo-controlled study evaluating COYA 302 in ALS across 20-25 sites in the U.S. and Canada.
Expected impact: Establish safety and efficacy of COYA 302 to support regulatory approval pathways.
Expanding the clinical utility of COYA 302 by initiating a prospective Phase 2a clinical study in patients with FTD, following positive investigator-initiated open-label data.
Expected impact: Validate Treg-enhancing mechanism in FTD and address a high unmet medical need.
Mergers, Acquisitions & Partnerships
Recent deals and strategic collaborations
Strategic Partnerships
High strategic importance for the co-development and commercialization of COYA 302 in ALS, providing non-dilutive funding and commercial infrastructure.
Terms: Includes a $7.5 million upfront payment, $4.2 million milestone upon FDA acceptance of the IND, and $4.2 million milestone upon dosing the first patient in the Phase 2 trial (received in December 2025). The agreement includes up to $40 million in development and regulatory milestones, plus low-to-mid teens royalties on net sales.