---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-208137"
form_type: "8-K"
ticker: "GRTX"
cik: "0001563577"
company_name: "Galera Therapeutics, Inc."
filed_at: "2023-08-10T23:59:59+00:00"
generated_at: "2026-06-11T17:30:02.805459+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.95
calibrated_materiality_score: 0.95
confidence: "high"
source: SEC EDGAR
---

# Galera Therapeutics receives FDA CRL for avasopasem; cuts workforce by 70% to extend cash runway

## Summary
- FDA issued CRL for avasopasem NDA; Phase 3 ROMAN + GT-201 data not sufficiently persuasive; additional trial required.
- Workforce reduced by 22 employees (~70%); estimated restructuring charges of $2.0M to $2.5M.
- Preliminary cash, equivalents, and short-term investments of $38.8M as of June 30, 2023; cash runway extended into Q2 2024.
- Mark Bachleda, Chief Commercial Officer, position eliminated in workforce reduction.
- Company intends to request Type A FDA meeting and explore strategic alternatives including partnering.

## SEC filing metadata
- accession: 0001193125-23-208137
- form_type: 8-K
- ticker: GRTX
- cik: 0001563577
- company_name: Galera Therapeutics, Inc.
- filed_at: 2023-08-10T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.95
- calibrated_materiality_score: 0.95
- confidence: high
- sec_items: 2.02, 2.05, 5.02, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1563577/000119312523208137/0001193125-23-208137-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1563577/000119312523208137/d538959d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-208137
- JSON: https://secwatch.observer/filing/0001193125-23-208137.json
- Plain text: https://secwatch.observer/filing/0001193125-23-208137.txt

## Key facts
- Earnings Releases
  Galera Therapeutics, Inc. reported preliminary financial results for the three months ended June 30, 2023.
  - Period: the three months ended June 30, 2023
  - Result: preliminary results
  source text: Preliminary Financial Results - Cash Balance as of June 30, 2023 On August 9, 2023, Galera Therapeutics, Inc. (the “Company”) announced that, based upon preliminary estimates and information available to the Company, it expects to report that it had cash, cash equivalents and short-term investments of approximately $38.8 million as of June 30, 2023.
  evidence_url: https://www.sec.gov/Archives/edgar/data/1563577/000119312523208137/0001193125-23-208137-index.htm
- Executive change
  Mark Bachleda departed as Chief Commercial Officer at Galera Therapeutics, Inc..
  - Action: eliminated
  - Role: Chief Commercial Officer
  source text: On August 9, 2023, Mark Bachleda, Pharm.D., the Company’s Chief Commercial Officer, was informed that his position was being eliminated in connection with the Workforce Reduction.
  evidence_url: https://www.sec.gov/Archives/edgar/data/1563577/000119312523208137/0001193125-23-208137-index.htm
- Restructurings & Charges
  Galera Therapeutics, Inc. announced a restructuring with charges of approximately $2.0 to $2.5 million affecting the Company’s current workforce (22 employees, approximately 70% of headcount) (22 employees, or approximately 70% of the Company’s headcount).
  - Type: restructuring
  - Charge: approximately $2.0 to $2.5 million
  - Affected area: the Company’s current workforce (22 employees, approximately 70% of headcount)
  - Headcount: 22 employees, or approximately 70% of the Company’s headcount
  source text: The decision was based on cost-reduction initiatives intended to reduce operating expenses. The Company currently estimates that it will incur charges of approximately $2.0 to $2.5 million in connection with the Workforce Reduction, primarily consisting of severance payments, employee benefits and related costs. The Company expects that the majority
  evidence_url: https://www.sec.gov/Archives/edgar/data/1563577/000119312523208137/0001193125-23-208137-index.htm

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