HOUSTON, November 12, 2025--(BUSINESS WIRE)--Coya Therapeutics, Inc. (NASDAQ: COYA) (Coya or the Company), a clinical-stage biotechnology company focused on developing biologics that enhance regulatory T cell (Treg) function in patients with neurodegenerative disorders, provides a corporate update and announces its financial results for the quarter ended September 30, 2025.
Recent Corporate Highlights
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Published a study in Frontiers in Immunology linking inflammation and oxidative stress to the progression of Parkinson’s disease.
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Announced FDA acceptance of Investigational New Drug (IND) application for COYA 302 for the treatment of Amyotrophic Lateral Sclerosis (ALS).
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Received $4.2 million from strategic partner Dr. Reddy’s Laboratories for the achievement of IND approval milestone.
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Launched the ALSTARS Trial, a Phase 2 clinical study to assess the efficacy and safety of COYA 302 in ALS.
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Announced COYA 302 ALS Trial accepted by NEALS as a NEALS-affiliated trial.
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Reported results from the first cohort of a preclinical in-vivo animal study demonstrating COYA 303 (LD IL-2 and GLP-1RA) showed promising Central Nervous System (CNS) anti-inflammatory effects and systemic regulatory T cell (Treg) enhancing effects.
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Completed patient enrollment in an investigator-initiated, open-label study with low-dose IL-2 and CTLA4-Ig combination treatment in patients with mild to moderate Frontotemporal Dementia (FTD).
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Announced closing of $23.0 million upsized public offering of common stock; financing extends cash runway into 2H 2027.
Upcoming Expected Catalysts
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First patient enrolled in COYA 302 ALSTARS Trial.
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First patient dosed in COYA 302 ALSTARS Trial.
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Upon first patient dosing of COYA 302 in ALS, expect to receive $4.2 million milestone payment from strategic partner, Dr. Reddy’s Laboratories (DRL).
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Presentation and publication of the comprehensive in-vivo animal data set of COYA 303 (LD IL-2 + CTLA-4 Ig) and impact on systemic and brain inflammation.
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ALS Biomarker data. Publication of longitudinal data on Neurofilament Light Chain (NfL) and oxidative stress markers in patients with ALS.
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Report additional single cell proteomics data from the completed investigator-initiated, 21-week, double-blind, placebo-controlled, exploratory Phase 2 study of low-dose interleukin-2 (LD IL-2) in patients with Alzheimer’s disease (AD).
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Top-line clinical data release for an investigator-initiated trial combining LD IL-2 + CTLA4-Ig in patients with FTD.
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IND submission for FTD anticipated in Q4 2025.
Coya’s Chief Executive Officer Arun Swaminathan, Ph.D. commented, "We believe the Company’s recent financing, which included participation from both new biotech and healthcare institutional investors and existing investors, is a testament to their confidence in our programs; we greatly appreciate their support. With this financing, we anticipate extending our runway into 2H 2027 and past the ALSTARS topline readout."
