secwatch.observer — SEC 8-K summary
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Issuer:     Coya Therapeutics, Inc. (COYA)
CIK:        0001835022
Form:       8-K
Filed at:   2026-10-14T12:30:08+00:00
Accession:  0001193125-26-421066
Event type: other_material
Sentiment:  neutral
Materiality: 0.50
Item codes: 8.01
LLM model:  deepseek-v4.1-flash:cloud@v2

Coya to launch OLE of COYA 302 ALS trial in Nov 2026; FTD Phase 2 slips to 2027
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- Open-label extension of the Phase 2/3 ALSTARS Trial (NCT07161999) for COYA 302 in ALS expected to begin November 2026 as the first cohort completes the 48-week treatment period.
- OLE initiated in response to requests from ALSTARS investigators and participants; it will gather longer-term efficacy and safety data on COYA 302.
- Phase 2 trial of COYA 302 in frontotemporal dementia, previously expected in H2 2026, is now expected in 2027 as resources are prioritized to the ALS program.
- Cash runway guidance unchanged: existing cash expected to fund operations into H2 2027, beyond the anticipated ALSTARS topline readout.
- ALSTARS design: ~120 patients randomized 1:1:1; 24-week double-blind phase plus 24-week blinded active extension; primary endpoint is ALSFRS-R change at Week 24.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1835022/000119312526421066/0001193125-26-421066-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1835022/000119312526421066/d172621d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-421066

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer