secwatch.observer — SEC 8-K summary
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Issuer:     Galera Therapeutics, Inc. (GRTX)
CIK:        0001563577
Form:       8-K
Filed at:   2023-03-08T23:59:59+00:00
Accession:  0001193125-23-063736
Event type: earnings
Sentiment:  neutral
Materiality: 0.75
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Galera reports FY2022 net loss $62.2M; avasopasem NDA priority review, PDUFA Aug 9, 2023
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- Q4 2022 net loss of $16.2M ($0.58 per share); FY2022 net loss $62.2M ($2.30 per share).
- Cash, cash equivalents and short-term investments $31.6M as of Dec 31, 2022; raised $30M in Feb 2023 offering.
- NDA for avasopasem (radiotherapy-induced severe oral mucositis) granted FDA priority review; PDUFA date August 9, 2023.
- No FDA-approved drug currently exists for SOM in head and neck cancer patients; ~43,500 US patients at high risk annually.
- Enrollment ongoing in Phase 2b GRECO-2 (LAPC) and GRECO-1 (NSCLC) trials of rucosopasem; completion expected H2 2023.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1563577/000119312523063736/0001193125-23-063736-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1563577/000119312523063736/d300354d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-063736

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