Coya Therapeutics began dosing patients in its Phase 2 ALSTARS trial for COYA 302 on December 9, 2025. The randomized, double‑blind, placebo‑controlled study is enrolling participants across the United States and Canada and represents the first step toward evaluating the safety and efficacy of a combination biologic that enhances regulatory T‑cell function in amyotrophic lateral sclerosis (ALS).
The company received a $4.2 million milestone payment from its strategic partner, Dr. Reddy’s Laboratories, when the U.S. Food and Drug Administration accepted the investigational new drug (IND) application for COYA 302. A separate $4.2 million payment is expected when the first patient is dosed, underscoring the partnership’s financial commitment to the program.
Coya’s Q3 2025 financial results show a net loss of $2.1 million, a significant improvement from the $4.0 million loss reported in Q3 2024. The company’s cash and cash equivalents stood at $28.1 million as of September 30, 2025, and a recent financing round has extended its runway into the second half of 2027, providing a stable foundation for continued clinical development.
CEO Arun Swaminathan said the new financing “extends our runway into 2H 2027 and beyond the ALSTARS topline readout,” while Chief Medical Officer Dr. Fred Grossman highlighted the trial’s design: “COYA 302 offers an innovative approach to treating ALS by restoring regulatory T‑cell function and suppressing inflammatory myeloid activity.”
The ALSTARS trial’s affiliation with the Northeast ALS Consortium (NEALS) enhances operational execution and clinical impact, positioning COYA 302 to address a critical unmet need in a disease with limited therapeutic options. The partnership with Dr. Reddy’s Laboratories not only provides financial support but also grants commercialization rights in key territories, strengthening Coya’s strategic positioning.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.