EX-99.1 2 engn-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 enGene Reports Third Quarter 2026 Financial Results and Provides Business Update Data update on key regulatory endpoints, complete response (CR) at any time and maturing durability, as well as landmark CR rates from LEGEND's pivotal cohort planned for 4Q 2026 Pre-Biologics License Application (BLA) meeting with the FDA on track for 4Q 2026 Initiation of BLA submission for detalimogene planned for 4Q 2026 Detalimogene plus surfactant cohort safety run-in successfully cleared; Webinar on surfactant plus detalimogene preclinical data and cohort enrollment guidance planned for October 15, 2026 Well-capitalized with $266 million in cash, cash equivalents, and marketable securities, supporting continued capital discipline and execution toward BLA filing and precommercial readiness BOSTON & MONTREAL, September 8, 2026 - enGene Therapeutics Inc. (Nasdaq: ENGN, “enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company, today announced its financial results for the third quarter ended July 31, 2026, and provided clinical and corporate updates. “As we move through the second half of 2026, our focus i…
Open exhibit ↗Current Report · Items 2.02, 9.01 · 8-K
enGene Therapeutics Inc.
ENGNNASDAQEQUITYCurrent
Results of Operations and Financial Condition
Item 2.02 Results of Operations and Financial Condition. On September 8, 2026, the Company announced its financial results for the three and nine months ended July 31, 2026. A copy of the press release issued in connection with the announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.…
Company context
enGene Therapeutics Inc. is a clinical-stage biotechnology company mainstreaming non-viral genetic medicine through the delivery of therapeutics to mucosal tissues and other organs, with the goal of creating new ways to address diseases with high clinical needs. enGene’s lead program is detalimogene voraplasmid (also known as detalimogene) for patients with non-muscle invasive bladder cancer (NMIBC), a disease with a high clinical burden. Detalimogene is being evaluated in the ongoing multi-cohort LEGEND Phase 2 trial, which includes a pivotal cohort studying detalimogene in high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive patients with carcinoma in situ (CIS) with or without concomitant papillary disease.