secwatch.observer — SEC 8-K summary
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Issuer:     Galera Therapeutics, Inc. (GRTX)
CIK:        0001563577
Form:       8-K
Filed at:   2023-08-14T23:59:59+00:00
Accession:  0001193125-23-211441
Event type: other_material
Sentiment:  negative
Materiality: 0.85
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Galera receives FDA CRL for avasopasem, cuts workforce 70%, Q2 net loss $20.7M
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- FDA issued Complete Response Letter for avasopasem NDA; additional clinical trial required for resubmission.
- Company reduced workforce by ~70% to extend cash runway into Q2 2024.
- Q2 net loss $(20.7)M, $(0.48) per share; R&D $7.6M, G&A $9.2M.
- Cash, equivalents and investments $38.8M as of June 30, 2023.
- Orphan drug designation for rucosopasem in pancreatic cancer; GRECO trials enrollment ongoing.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1563577/000119312523211441/0001193125-23-211441-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1563577/000119312523211441/d517610d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-211441

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