Coya Therapeutics, Inc., a clinical-stage biotechnology company focused on developing therapies to enhance regulatory T cells (Tregs), reported a net loss of $21.2 million for the year ended December 31, 2025, compared to a loss of $14.9 million in the previous year. The company's accumulated deficit reached $62.0 million as of the end of 2025. Coya's collaboration revenue increased to $7.9 million, up from $3.6 million in 2024, primarily due to milestone payments from its partnership with Dr. Reddy's Laboratories related to the development of its lead asset, COYA 302, for amyotrophic lateral sclerosis (ALS).
Research and development expenses rose significantly, totaling $16.7 million in 2025, compared to $11.9 million in 2024. This increase was attributed to higher clinical expenses associated with the advancement of COYA 302, as well as increased internal research and sponsored research costs. General and administrative expenses also increased to $11.4 million from $8.9 million, driven by higher payroll, professional service fees, and investor relations costs. The company anticipates continued significant operating losses as it advances its product candidates through clinical trials and seeks regulatory approvals.
Coya is currently conducting the ALSTARS Trial, a Phase 2 study evaluating the efficacy and safety of COYA 302 in ALS patients, with enrollment expected to be completed in the second half of 2026. The company has also received FDA approval for an Investigational New Drug (IND) application for COYA 302 for frontotemporal dementia (FTD) and plans to initiate a clinical trial for this indication. Additionally, Coya is developing COYA 303, a new product candidate for inflammatory diseases, and has entered into various licensing agreements to support its research and development efforts.
As of December 31, 2025, Coya had $46.8 million in cash and cash equivalents, which, along with recent financing activities, is expected to fund operations into the second half of 2027. The company plans to continue raising capital through equity offerings and collaborations to support its ongoing research and development activities. Coya's future success will depend on the successful development and commercialization of its product candidates, as well as its ability to navigate the complex regulatory landscape and secure adequate funding.
About Coya Therapeutics, Inc.
Coya Therapeutics is a clinical-stage biotech focused on developing therapies that enhance regulatory T cell (Treg) function to treat neurodegenerative, autoimmune, and metabolic diseases. Its core products include biologics, Treg-derived exosomes, and autologous Treg cell therapies, targeting immune dysregulation. The company leverages innovative combination approaches, aiming to restore immune balance and address high unmet medical needs in complex inflammatory conditions.
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