{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-328706","form_type":"8-K","ticker":"ENGN","cik":"0001980845","company_name":"enGene Therapeutics Inc.","filed_at":"2025-12-22T23:59:59+00:00","discovered_at":"2026-05-14T18:02:41.208554+00:00","generated_at":"2026-05-16T12:29:00.201332+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"enGene FY2025 net loss $117.3M; LEGEND pivotal cohort complete (125 pts), 62% CR at 6 months; cash runway to 2H 2028","bullets":["FY2025 net loss $117.3M ($2.29/sh) vs $55.1M ($1.46/sh) in 2024; R&D expenses up $56.2M to $123.2M total OpEx.","LEGEND pivotal cohort enrollment complete with 125 patients; preliminary CR rate 62% at 6 months (post-amendment patients).","Cash, equivalents, and marketable securities $202.3M at Oct 31, 2025; plus $140.1M net from Nov offering; runway into 2H 2028.","FDA selected enGene for CDRP program to support CMC readiness; BLA filing for detalimogene planned for 2H 2026.","Appointed Dr. Hussein Sweiti as CMO in September; he previously led J&J's bladder cancer portfolio leading to FDA approval."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-328706","json":"https://secwatch.observer/filing/0001193125-25-328706.json","markdown":"https://secwatch.observer/filing/0001193125-25-328706.md","text":"https://secwatch.observer/filing/0001193125-25-328706.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1980845/000119312525328706/0001193125-25-328706-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1980845/000119312525328706/engn-20251222.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T12:29:00.201332+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":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}