---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-22-269333"
form_type: "8-K"
ticker: "GRTX"
cik: "0001563577"
company_name: "Galera Therapeutics, Inc."
filed_at: "2022-10-26T23:59:59+00:00"
generated_at: "2026-06-23T00:49:24.167225+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Galera presents positive Phase 3 ROMAN one-year data; meta-analysis confirms SOM reduction; NDA on track

## Summary
- One-year follow-up: avasopasem maintained comparable tumor outcomes and overall survival vs placebo in HNC patients.
- CKD incidence 10% (avasopasem) vs 20% (placebo) at one year (p=0.0043), a 50% reduction.
- Meta-analysis (n=551): avasopasem reduced SOM incidence by 19% (p=0.0053) and median days of SOM by 58% (p=0.0002).
- Meta-analysis also showed 28% delay in SOM onset (p=0.0005) and 32% reduction in Grade 4 incidence (p=0.0102).
- NDA submission for avasopasem for radiotherapy-induced SOM still on track for end of 2022.

## SEC filing metadata
- accession: 0001193125-22-269333
- form_type: 8-K
- ticker: GRTX
- cik: 0001563577
- company_name: Galera Therapeutics, Inc.
- filed_at: 2022-10-26T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1563577/000119312522269333/0001193125-22-269333-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1563577/000119312522269333/d399266d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-22-269333
- JSON: https://secwatch.observer/filing/0001193125-22-269333.json
- Plain text: https://secwatch.observer/filing/0001193125-22-269333.txt

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