ENGN
enGene Holdings Inc.8.38
-0.05-0.59%
Dec 16, 4:00:01 PM EST
Earnings Call Transcripts
This Quarter (Q4 '25)
No earnings call transcript available yet
Last Quarter (Q3 '25)
No earnings call transcript available
Key Stats
Market Cap
560.39MP/E (TTM)
-Basic EPS (TTM)
-1.90Dividend Yield
0%Recent Filings
8-K
8-K
enGene names new CMO
enGene Holdings appointed Dr. Hussein Sweiti as Chief Medical Officer effective September 29, 2025, bringing his 15+ years of oncology expertise, including leading Johnson & Johnson's recent FDA approval for bladder cancer treatment. This bolsters clinical strategy as the company eyes a BLA submission for detalimogene in the second half of 2026, following target enrollment in its pivotal LEGEND trial. Sweiti's regulatory savvy sharpens focus on commercialization. Yet risks like trial delays loom.
10-Q
Q3 FY2025 results
enGene Holdings posted a $29.0M net loss for Q3 FY2025 ended July 31, 2025, up 105% y/y from $14.1M, driven by R&D expenses doubling to $22.6M on ramped-up manufacturing and clinical work for its lead detalimogene program in BCG-unresponsive NMIBC. Operating loss widened to $29.9M, 79% higher y/y, while diluted EPS slipped to -$0.57 from -$0.32, consistent with 51.1M weighted shares. Cash burn accelerated with $74.3M used in operations YTD, leaving $32.6M in cash equivalents and $192.3M in marketable securities against $23.1M debt due mostly in 2026 at 11.63% effective rate; free cash flow not disclosed in the 10-Q. Yet cash runway extends at least 12 months per management. Regulatory hurdles loom large in advancing the pivotal LEGEND trial.
8-K
enGene hits LEGEND enrollment milestone
enGene Holdings hit target enrollment of 100 patients in the pivotal cohort of its Phase 2 LEGEND trial for detalimogene in high-risk, BCG-unresponsive NMIBC with CIS, while securing FDA RMAT designation for regulatory perks like priority review. Cash reserves stand at $224.9 million, funding operations into 2027 despite Q3 net loss of $28.9 million from ramped R&D costs. BLA submission is eyed for 2H 2026. Momentum builds, yet trial risks loom.
8-K
enGene reaches 100-patient milestone in LEGEND trial for detalimogene in high-risk NMIBC with CIS; BLA submission targeted for 2H 2026.
enGene Holdings Inc. (Nasdaq: ENGN) announced achieving target enrollment of 100 patients in the pivotal cohort of its Phase 2 LEGEND trial for detalimogene voraplasmid in high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS). The trial evaluates detalimogene in BCG-unresponsive patients, with potential over-enrollment. The company plans a BLA submission in 2H 2026.
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