Coya Therapeutics (NASDAQ: COYA), a clinical-stage biotechnology company advancing therapies that enhance regulatory T cell (Treg) function for the treatment of neurodegenerative disorders, reported its second quarter 2025 results and provided updates on several near-term milestones.
During Q2, Coya submitted additional nonclinical data to the FDA in support of initiating its Phase 2 trial of lead investigational candidate COYA 302 in amyotrophic lateral sclerosis (ALS). The FDA is expected to make a decision on the IND application by or before August 29, 2025. A positive outcome could trigger $8.4 million in milestone payments from partner Dr. Reddy’s Laboratories.
The company also published research linking inflammation and oxidative stress to the progression of Parkinson’s disease and secured a U.S. patent for a stable, ready-to-use liquid IL-2 formulation with exclusive in-vivo rights across multiple indications.
Looking ahead to the second half of 2025, Coya anticipates key readouts including ALS biomarker data, new proteomics data from an Alzheimer’s trial, and top-line results from studies in Frontotemporal Dementia (FTD) and inflammatory models. An IND filing for COYA 302 in FTD is planned by year-end.
As of June 30, 2025, Coya held $29.8 million in cash and equivalents. Q2 collaboration revenue was $0.2 million compared to $3.4 million in the prior-year period, which included a one-time license revenue recognition. R&D expenses decreased to $3.7 million from $4.6 million, while G&A expenses increased to $2.9 million from $2.1 million. Net loss widened to $6.1 million versus $2.9 million in Q2 2024.
COYA 302 is a proprietary biologic combination therapy designed to enhance anti-inflammatory Treg function while suppressing harmful immune activity from monocytes and macrophages. It is in development for ALS and FTD. COYA 303, another investigational biologic candidate, combines COYA 301 with a GLP-1 receptor agonist, aiming for synergistic anti-inflammatory effects.
Coya is entering a catalyst-rich period, with an FDA decision on COYA 302 in ALS expected within weeks. This decision could unlock milestone payments, initiate Phase 2 development, and serve as a key inflection point for the company’s Treg-focused platform. Upcoming data from multiple neurodegeneration programs could further validate its approach, supported by a strong cash position to fund near-term operations.
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