---
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"
generated_at: "2026-05-16T12:29:00.201332+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: earnings
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-328706
- JSON: https://secwatch.observer/filing/0001193125-25-328706.json
- Plain text: https://secwatch.observer/filing/0001193125-25-328706.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.