secwatch.observer — SEC 8-K summary
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Issuer:     enGene Therapeutics Inc. (ENGN)
CIK:        0001980845
Form:       8-K
Filed at:   2025-12-22T23:59:59+00:00
Accession:  0001193125-25-328706
Event type: earnings
Sentiment:  positive
Materiality: 0.75
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

enGene FY2025 net loss $117.3M; LEGEND pivotal cohort complete (125 pts), 62% CR at 6 months; cash runway to 2H 2028
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1980845/000119312525328706/0001193125-25-328706-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1980845/000119312525328706/engn-20251222.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-328706

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