secwatch.observer — SEC 8-K summary
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Issuer:     enGene Therapeutics Inc. (ENGN)
CIK:        0001980845
Form:       8-K
Filed at:   2025-09-11T23:59:59+00:00
Accession:  0000950170-25-114220
Event type: earnings
Sentiment:  neutral
Materiality: 0.70
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

enGene Q3 net loss $28.9M; hits LEGEND enrollment target, RMAT designation
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- Cash and marketable securities $224.9M; net loss $28.9M ($0.57/share) vs $14.1M ($0.32/share) YoY.
- Achieved target enrollment of 100 patients in LEGEND pivotal cohort; data update expected 4Q 2025.
- Detalimogene granted FDA RMAT designation; BLA submission planned for 2H 2026.
- Operating expenses $29.9M, up from $16.8M; R&D costs increased $11M on LEGEND manufacturing and clinical costs.
- Board appointed Philip Astley-Sparke, William Grossman, Michael Heffernan; promoted Matthew Boyd, Jill Buck, Katherine Chan.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1980845/000095017025114220/0000950170-25-114220-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1980845/000095017025114220/engn-20250911.htm
  HTML page:      https://secwatch.observer/filing/0000950170-25-114220

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