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Coya Therapeutics Provides a Corporate Update and Reports Fiscal 2025 Financial Results
HOUSTON--(BUSINESS WIRE)-- Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics
About this update from Coya Therapeutics, Inc.
[{"type":"text","content":" HOUSTON--(BUSINESS WIRE)--\nCoya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance T-cell (Treg) function in patients with neurodegenerative disorders, provides a corporate update and announces its financial results for the year ended December 31, 2025.\n\n\nCorporate Highlights FY 2025 to Date\n\n\n\nCOYA 302\n\n\nSuccessfully launched the ALSTARS Phase 2 trial evaluating COYA 302 for the treatment of ALS and now actively enrolling and dosing patients across ~25 clinical sites in the U.S. and Canada.\n\n\n\nClinical Trial Application (CTA) acceptance from Health Canada to proceed with the COYA 302 ALSTARS Phase 2 trial in Canada.\n\n\n\nAnnounced COYA 302 ALS trial acceptance by NEALS as a NEALS-affiliated trial.\n\n\n\nAnnounced U.S. FDA acceptance of Investigation New Drug (IND) Application for COYA 302 for the treatment of frontotemporal dementia (FTD).\n\n\n\nReported results of the investigator-initiated study of low-dose IL-2 and CTLA4-Ig combination treatment demonstrating Treg enhancement and cognitive stability in FTD patients.\n\n\n\n\n\n\nCOYA 303\n\n\nReported interim findings of COYA 303 showing potent systemic and brain anti-inflammatory activity and enhanced Treg cell function in an in vivo lipopolysaccharide (LPS) preclinical mouse model of systemic and neurologic inflammation.\n\n\n\n\n\n\nScientific validation\n\n\nPublished results in Frontiers in Immunology linking inflammation and oxidative stress to the progression of Parkinson’s disease.\n\n\n\nPublished results in the Journal NeuroImmune Pharmacology and Therapeutics demonstrating COYA 303’s synergistic enhancement of regulatory T cell function and protection against Treg apoptosis (cell death).\n\n\n\n\n\n\nAnnounced the issuance of a U.S. patent relevant to its investigational ready-to-use (RTU) liquid formulation of IL-2. Through an existing agreement, Coya has the exclusive in vivo rights to this patent and other related intellectual property spanning multiple indications both as monotherapy and combination therapies.\n\n\n\nFinancial Highlights FY 2025 to Date\n\n\n\nAnnounced $23.0 million upsized public offering of common stock; extends cash runaway into 2H 2027.\n\n\n\nAnnounced $11.1 million private placement, led by Dr. Reddy’s Laboratories, Inc. ($10 mi...