Key Highlights

  • Loss was USD 0.45 per share against an estimated USD 0.34 loss, while Revenue of USD 234,130 beat estimates.
  • Net loss was USD 10.6 million, up from USD 2.1 million, as research spending rose to USD 8.6 million.
  • Cash was USD 35.8 million, and the filing states substantial doubt exists about continuing as a going concern.
  • Enrollment in the ALSTARS Phase 2/3 trial of its lead candidate in ALS is complete with 137 subjects.

Coya Therapeutics (NASDAQ:COYA), a clinical-stage biotechnology company, reported a third quarter 2026 loss of USD 0.45 per share, wider than the USD 0.34 estimated loss. Revenue of USD 234,130 exceeded the USD 110,000 estimate. Collaboration revenue was USD 0.2 million and consisted of Research and Development services.

Net loss was USD 10.6 million for the quarter against USD 2.1 million a year earlier, and USD 24.5 million for the nine months against USD 15.5 million. The prior-year quarter included USD 3.3 million of license revenue recognized on FDA acceptance of the investigational new drug application for the Phase 2/3 ALSTARS study, which is why revenue was USD 3.6 million then.

Spending and Cash

Research and development expenses rose USD 5.7 million to USD 8.6 million, reflecting the advancement of the Phase 2/3 trial of its lead candidate in amyotrophic lateral sclerosis. General and administrative expenses were USD 2.6 million in both periods. The accumulated Deficit was USD 86.4 million.

Cash and cash equivalents were USD 35.8 million at September 30. Financing activities provided USD 11.0 million in the nine months from the net proceeds of a January 2026 offering, less USD 0.2 million of costs related to the at-the-market program. No shares were sold under that program in the nine months, and USD 30.0 million remained available.

The filing states that, as a result of recurring losses and negative cash flows, substantial doubt exists about the company's ability to continue as a going concern.

The ALSTARS Trial and Fast Track Status

The company is conducting ALSTARS, a Phase 2/3 randomized, multi-center, double-blind, placebo-controlled study of its lead candidate for ALS. Enrollment is complete with 137 subjects. On May 11, 2026, the FDA granted Fast Track Designation to the candidate for ALS. The company has described the candidate as a pipeline in a product because of the growing list of indications it is exploring, including frontotemporal dementia.

The company has granted a partner an exclusive, royalty-bearing license to commercialize the candidate solely for ALS patients in the United States, Canada, the European Union and the United Kingdom. Research and development services revenue under that agreement is recognized over time by applying actual program expenses against budgeted expenses.

Items to Follow

The main markers are the cash balance against the rising research spending, which more than tripled in the quarter, any use of the at-the-market program, how the Going Concern language develops in later filings and the timeline for ALSTARS data. Collaboration revenue depends on service activity and can vary quarter to quarter, as the comparison with the prior-year license revenue shows. The ALSTARS enrollment figure of 137 subjects is the other number the filing repeats.