FDA Decision on COYA 302 in ALS Expected by Month-End, Potentially Unlocking $8.4 Million Milestone Payment
Coya Therapeutics (NASDAQ: COYA), a clinical-stage biotech developing therapies that enhance regulatory T cell (Treg) function to treat neurodegenerative disorders, reported its second quarter 2025 results and outlined multiple upcoming catalysts.
Corporate and Clinical Highlights
In Q2, Coya submitted additional nonclinical data to the FDA to support initiation of its lead investigational candidate COYA 302 Phase 2 trial in ALS. A decision on the IND is expected by or before August 29, 2025, which 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 Parkinson’s disease progression and secured a U.S. patent for a stable, ready-to-use liquid IL-2 formulation with exclusive in-vivo rights across multiple indications.
Coya anticipates a busy second half of 2025, with 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 also planned by year-end.
Financial Overview
As of June 30, 2025, Coya reported $29.8 million in cash and equivalents. Q2 collaboration revenue was $0.2 million versus $3.4 million in the same quarter last year, reflecting the prior year’s one-time license revenue recognition. R&D expenses decreased to $3.7 million from $4.6 million, while G&A expenses rose to $2.9 million from $2.1 million. Net loss widened to $6.1 million from $2.9 million in Q2 2024.
Pipeline Focus
COYA 302, Coya’s lead investigational candidate, is a proprietary biologic combination therapy designed to enhance anti-inflammatory Treg function and suppress 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 for potential synergistic anti-inflammatory effects.
Investor Takeaway
Coya enters a catalyst-rich period with an FDA decision on its lead investigational candidate COYA 302 in ALS expected within weeks, potentially unlocking partner milestone payments and Phase 2 trial initiation. Additional data across its neurodegeneration pipeline could further validate its Treg-focused platform. With a strong cash position for near-term operations, investors will be watching the IND outcome closely as a key inflection point for the company’s lead program.
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