Coya Therapeutics, Inc. (COYA)

Coya Therapeutics, Inc. is a clinical-stage biotechnology company developing proprietary therapies that enhance the function of regulatory T cells (Tregs), a subpopulation of T-lymphocytes that suppress inflammatory responses. The company's core focus is Treg dysfunction, which it describes as an important component of neurodegenerative, autoimmune and metabolic diseases. It has devoted substantially all of its resources to product and technology rights, research and development, staffing and capital raising, and has funded operations mainly through private and public sales of its securities. It reported net losses of $21.2 million for 2025 and $14.9 million for 2024, an accumulated deficit of $62.0 million at year-end 2025, and says it will need substantial additional capital.

Coya works in three modalities: Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. The autologous Treg program has completed Phase 1 and Phase 2a studies in amyotrophic lateral sclerosis (ALS). Its lead asset, COYA 302, combines its proprietary low dose interleukin-2 (COYA 301) with the immunomodulatory drug CTLA4-Ig. The FDA accepted the IND for COYA 302 in ALS in August 2025, and dosing in the Phase 2 randomized, double-blind, placebo-controlled ALSTARS Trial began in December 2025, with enrollment expected to finish in the second half of 2026. In January 2026 the FDA also accepted an IND for COYA 302 in frontotemporal dementia (FTD). An investigator-initiated open-label study in nine FTD patients reported no serious adverse events, enhanced Treg numbers and function, and stable cognitive function. COYA 303 combines COYA 301 with a GLP-1 receptor agonist for inflammatory diseases and is preclinical, with in vitro and mouse model data. The company intends to seek partnerships and grants to advance it. Strategy includes using COYA 301 as a backbone for combination therapies, exploring COYA 302 in Parkinson's and Alzheimer's disease and possibly autoimmune diseases, and advancing exosomes with Houston Methodist Hospital under a sponsored research agreement.

The company targets unmet needs in neurodegenerative, autoimmune and metabolic diseases, with initial focus on ALS and FTD. It has no product revenue, and its ability to generate any depends on successful development and commercialization of its candidates. It intends to pursue partnering or licensing for COYA 301 and COYA 302, including in indications and geographies it has retained for ALS. Dr. Reddy's Laboratories is a strategic collaborator on COYA 302 for ALS. In January 2026 Coya completed an $11.1 million financing, $10 million of it from a Dr. Reddy's subsidiary, to accelerate tech transfer and scale-up manufacturing of low dose IL-2 for commercial readiness. Cash runway is expected to extend into the second half of 2027.

Coya relies on external manufacturing capacity and is scaling it up for clinical trials and potential commercialization. If products are approved, it expects to build sales, marketing and distribution infrastructure. It also plans to protect its intellectual property portfolio and to acquire or in-license other candidates and technologies. The text mentions that Dr. Shimon Sakaguchi, discoverer of Tregs and 2025 Nobel laureate, sits on its Scientific Advisory Board. It identifies other Treg companies as points of differentiation, but the text provided does not name competitors or give headquarters details.