---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-421066"
form_type: "8-K"
ticker: "COYA"
cik: "0001835022"
company_name: "Coya Therapeutics, Inc."
filed_at: "2026-10-14T12:30:08+00:00"
generated_at: "2026-10-14T12:35:03.727228+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.5
calibrated_materiality_score: 0.5
confidence: "high"
source: SEC EDGAR
---

# Coya to launch OLE of COYA 302 ALS trial in Nov 2026; FTD Phase 2 slips to 2027

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-26-421066
- form_type: 8-K
- ticker: COYA
- cik: 0001835022
- company_name: Coya Therapeutics, Inc.
- filed_at: 2026-10-14T12:30:08+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.5
- calibrated_materiality_score: 0.5
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1835022/000119312526421066/0001193125-26-421066-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1835022/000119312526421066/d172621d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-421066
- JSON: https://secwatch.observer/filing/0001193125-26-421066.json
- Plain text: https://secwatch.observer/filing/0001193125-26-421066.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.