Key Highlights

  • Net loss for the quarter ended September 30, 2026 was USD 10.6 million, or USD 0.45 per share, compared with USD 2.1 million, or USD 0.13 per share, in the third quarter of 2025.
  • Collaboration Revenue fell to USD 0.2 million from USD 3.6 million, because the prior-year period included USD 3.3 million of license revenue recognized after FDA acceptance of the ALSTARS trial application.
  • Research and development expense rose to USD 8.6 million from USD 2.9 million, driven mainly by external costs of USD 6.8 million for the COYA 302 ALS trial.
  • Cash and cash equivalents were USD 35.8 million at September 30, 2026, and the filing states that substantial doubt exists about the company's ability to continue as a going concern.

Revenue Drop and Trial Costs Widen the Quarterly Loss

Coya Therapeutics (NASDAQ:COYA) filed its Quarterly Report on November 10, 2026, covering the three months ended September 30, 2026. The clinical-stage company develops therapies that enhance the function of regulatory T cells, and its lead asset is COYA 302, a combination of low dose interleukin-2 and CTLA4-Ig. Net loss was USD 10.6 million against USD 2.1 million a year earlier. Operating expenses were USD 11.2 million versus USD 6.0 million, while collaboration revenue was USD 0.2 million versus USD 3.6 million. General and administrative expense was flat at USD 2.6 million, so the widening came from research spending and the missing license revenue.

Inside the Going Concern Language and the ALSTARS Trial

A going concern note means management's projections show cash will not cover operations for more than one year after the financial statements were issued. The company said it does not expect that USD 35.8 million to last that long and will need substantial additional financing, with dilutive and non-dilutive sources under review. It used USD 20.8 million of cash in operations over nine months and raised USD 11.0 million net from a January 2026 stock offering. The ALSTARS Phase 2/3 trial in amyotrophic lateral sclerosis has completed enrollment with 137 subjects, and the FDA granted Fast Track Designation to COYA 302 on May 11, 2026. The trial runs two 24-week periods, so cash needs continue while it proceeds.

Partner Payments and the Funding Gap the Filing Describes

Dr. Reddy's holds commercialization rights to COYA 302 under development and Supply agreements. The company received a USD 7.5 million upfront payment in January 2024, plus USD 4.2 million in August 2025 and another USD 4.2 million in December 2025 on development events. The agreement also provides for up to USD 40.0 million in further development milestones. Nine-month net loss reached USD 24.5 million against USD 15.5 million, and the accumulated Deficit was USD 86.4 million. Milestone payments are tied to events, so revenue can swing sharply from quarter to quarter, as this quarter showed. No guidance, consensus figure or share price reaction was included in the material reviewed.

Where Things Stand

The going concern language is a funding warning, not a verdict on the science. Coya Therapeutics (NASDAQ:COYA) holds USD 35.8 million in cash against a nine-month operating cash burn of USD 20.8 million, and management said additional Capital is required to keep running its ALS program. Partner milestones and Equity sales are the funding routes named. Next markers include results from the 137-patient ALSTARS trial, any further development milestones from Dr. Reddy's and the terms of any new financing.