Coya Therapeutics, Inc.

What they do

Coya develops therapies intended to restore the function of regulatory T cells (Tregs), a subset of T-lymphocytes that suppress inflammatory responses. Its lead asset, COYA 302, combines proprietary low-dose IL-2 (COYA 301) with the immunomodulatory drug CTLA4-Ig. The company is running the ALSTARS Phase 2 trial of COYA 302 in ALS and has completed Phase 1 and Phase 2a studies of an autologous Treg cell therapy in ALS. It also operates early-stage programs in Treg-derived exosomes and COYA 303.

Revenue drivers

• Collaboration revenue (DRL agreement) — Revenue is from R&D services under the Development and License Agreement with DRL; $0.2M in Q2 2026 and $0.2M in Q2 2025, and $3.6M and $4.0M in the quarters ended 2025-09-30 and 2025-12-31 respectively.
• COYA 302 (lead asset) — Not yet commercialized; no product is approved for sale. It is the most clinically advanced asset, in a Phase 2 ALS trial (ALSTARS) and a planned Phase 2 in FTD.
• Autologous Treg cell therapy — Phase 1 and Phase 2a studies in ALS are complete; no revenue is generated and the program supports understanding of Treg biology rather than current sales.

Recent performance

Second quarter 2026 collaboration revenue was $0.2 million, unchanged from $0.2 million in Q2 2025, both tied to R&D services under the DRL agreement. R&D expenses rose to $5.0 million from $3.7 million, driven by a $1.1 million increase in preclinical and clinical product candidate costs mainly from the COYA 302 ALS Phase 2 trial, and a $0.4 million increase in internal R&D. G&A fell to $2.3 million from $2.9 million on lower professional services and employee compensation. Net loss was $6.6 million versus $6.1 million a year earlier. Cash and cash equivalents were $43.2 million as of June 30, 2026.

Strategy

Coya's priority is advancing COYA 302, described as a 'Pipeline in a Product,' across neurodegenerative indications. It plans to complete ALSTARS Phase 2 enrollment in 2026 and report topline data in Q1 2027, and to initiate a Phase 2 trial in frontotemporal dementia in the coming months. The company also expects biomarker data from an investigator-initiated FTD study and additional single-cell proteomics data from completed ALS and AD trials in 2H 2026. It funds these efforts primarily through private and public securities sales.

Risks

• No approved products — Coya is clinical-stage with no product approved for commercial sale, so it has no product revenue and depends on development success.
• License dependence — It relies on license agreements for certain intellectual property rights relating to autologous Treg technology, and termination could remove rights material to its product candidates.
• Capital needs — The company states it will need to raise significant additional capital, which may not be available on acceptable terms or at all.
• Clinical delay risk — It may encounter substantial delays in planned clinical trials or be unable to conduct or complete them as planned.

Outlook

Management expects to complete ALSTARS Phase 2 enrollment for COYA 302 in ALS in 2H 2026 and report topline data in Q1 2027. It plans to initiate a Phase 2 study in FTD in 2H 2026, along with biomarker data from an FTD investigator-initiated study and additional ALS and AD proteomics data. Coya says its $43.2 million cash balance funds operations past the ALSTARS topline readout and into the second half of 2027. It also received FDA Fast Track Designation for COYA 302 in ALS.