{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-063736","form_type":"8-K","ticker":"GRTX","cik":"0001563577","company_name":"Galera Therapeutics, Inc.","filed_at":"2023-03-08T23:59:59+00:00","discovered_at":"2026-05-14T18:03:45.592914+00:00","generated_at":"2026-06-18T08:29:28.324728+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Galera reports FY2022 net loss $62.2M; avasopasem NDA priority review, PDUFA Aug 9, 2023","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-063736","json":"https://secwatch.observer/filing/0001193125-23-063736.json","markdown":"https://secwatch.observer/filing/0001193125-23-063736.md","text":"https://secwatch.observer/filing/0001193125-23-063736.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1563577/000119312523063736/0001193125-23-063736-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1563577/000119312523063736/d300354d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-18T08:29:28.324728+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[{"claim_id":"5254579ca32c26a361cdd85627108d5a2b9b0453","claim":"Galera Therapeutics, Inc. reported the fourth quarter ended December 31, 2022 results: net income $(16.2) million, or $(0.58) per share, EPS $(0.58) per share.","evidence_excerpt":"Galera reported a net loss of $(16.2) million, or $(0.58) per share, for the fourth quarter of 2022","evidence_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1563577/000119312523063736/0001193125-23-063736-index.htm","confidence":0.95,"family_label":"Earnings Releases","details":[{"label":"Period","value":"the fourth quarter ended December 31, 2022"},{"label":"Net income","value":"$(16.2) million, or $(0.58) per share"},{"label":"EPS","value":"$(0.58) per share"},{"label":"Result","value":"reported results"}],"fact_type":"earnings_release"},{"claim_id":"5b30056cf4e2ad39ab29d141b05e396ad821cf4f","claim":"Galera Therapeutics, Inc. reported the year ended December 31, 2022 results: net income $(62.2) million, or $(2.30) per share, EPS $(2.30) per share.","evidence_excerpt":"Galera reported a net loss of $(62.2) million, or $(2.30) per share, for the year ended December 31, 2022","evidence_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1563577/000119312523063736/0001193125-23-063736-index.htm","confidence":0.95,"family_label":"Earnings Releases","details":[{"label":"Period","value":"the year ended December 31, 2022"},{"label":"Net income","value":"$(62.2) million, or $(2.30) per share"},{"label":"EPS","value":"$(2.30) per share"},{"label":"Result","value":"reported results"}],"fact_type":"earnings_release"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}