Coya Therapeutics has completed enrollment in its Phase 2/3 ALSTARS study of COYA 302 in amyotrophic lateral sclerosis (ALS) and expects to report topline results in early second-quarter 2027. The clinical-stage biotech also plans to offer an open-label extension to participants who finish the study, while reporting a wider quarterly loss as spending rose with the ALS trial’s progress.
Key details
- ALSTARS enrollment is complete. The study was designed for 120 participants, but 137 were enrolled after people already in screening were allowed to enter the trial.
- An extension is planned. Participants who complete the 48-week study will have the opportunity to continue receiving COYA 302 in an open-label extension. The company says the extension responds to requests from investigators and participants.
- The main data milestone is expected in early Q2 2027. Coya plans to report topline results from the trial’s 24-week double-blind treatment phase. The extension is separate from that planned readout.
- Other research updates are expected.
- From the fourth quarter of 2026 through the first quarter of 2027, Coya expects to report additional mechanistic and single-cell proteomics data from completed investigator-led ALS and Alzheimer’s disease studies, subject to publication.
- In the first quarter of 2027, it expects to announce biomarker data from a completed investigator-led study in frontotemporal dementia (FTD).
- Coya plans to start a Phase 2 study of COYA 302 in FTD in 2027.
- The company also highlighted work on other programs. It presented a neurofilament light chain biomarker-stratification approach at the 2026 NEALS meeting, aimed at reducing the effects of patient variability in ALS trials. It also reported publication of preclinical COYA 303 results showing complementary immunomodulatory effects in a model of inflammation affecting the peripheral and central nervous systems.
- Cash was $35.8 million at September 30, 2026. Coya said that amount is expected to fund operations, as currently planned, beyond the ALSTARS topline readout and into the second half of 2027.
- Quarterly research and development costs rose. R&D expenses increased to $8.6 million from $2.9 million a year earlier, primarily because of higher preclinical and clinical costs as the COYA 302 ALS trial advanced. General and administrative expenses were $2.6 million in both periods.
- Net loss widened to $10.6 million from $2.1 million. Collaboration revenue was $0.2 million, compared with $3.6 million in the year-earlier quarter. The prior-year figure included $3.3 million of license revenue recognized after FDA acceptance of the COYA 302 ALS trial application; the 2026-quarter revenue consisted of R&D services. No license milestone payments were incurred in the latest quarter, compared with $0.5 million of in-process research and development expense a year earlier.
Plain-English implications
The completed enrollment moves ALSTARS into the period leading up to its planned data readout, while the extension gives eligible participants the option to continue treatment beyond the main study. Coya’s stated cash runway extends beyond that readout, but the company remains in a period of substantial clinical-development spending and reported a larger quarterly loss.