- enGene Holdings Inc. reported a **net loss attributable to common shareholders of $28.9 million**, or **$0.57 per share**, for the third quarter ended July 31, 2025.  **[1980845_0000950170-25-114220_engn-ex99_1.htm:1]** **[1980845_0000950170-25-114220_engn-ex99_1.htm:4]** 
- As of July 31, 2025, the company held **cash, cash equivalents, and marketable securities of $224.9 million**, which is expected to provide a cash runway into **2027**.  **[1980845_0000950170-25-114220_engn-ex99_1.htm:0]** **[1980845_0000950170-25-114220_engn-ex99_1.htm:4]** 
- The company achieved its **target enrollment milestone of 100 patients** for the pivotal cohort of its LEGEND trial, with an **updated preliminary data** from this cohort anticipated in **4Q 2025**.  **[1980845_0000950170-25-114220_engn-ex99_1.htm:0]** 
- Detalimogene was granted **Regenerative Medicine Advanced Therapy (RMAT) designation** by the FDA, and a **Biologic License Application (BLA) submission** is planned for **2H 2026**.  **[1980845_0000950170-25-114220_engn-ex99_1.htm:0]**

enGene Holdings Inc. Reports Q3 2025 Financial Results and Key Clinical Milestones

- enGene's lead asset, **detalimogene voraplasmid**, for BCG-resistant non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), has **hit its target enrollment** in a pivotal study.  **[1980845_2137651_0]**  The company anticipates filing a Biologics License Application (BLA) in the **second half of next year** and potential approval in **2027**.  **[1980845_2137651_5]** 
- Based on September 2024 data, detalimogene voraplasmid demonstrated a **71% CR rate anytime** and **good tolerability**, with an emphasis on its ease of administration and favorable practice economics for community urologists.  **[1980845_2137651_1]** 
- The company is **well-capitalized** with **over $250 million in cash**, providing a cash runway into **2027**, and is actively preparing for commercialization, including manufacturing at scale.  **[1980845_2137651_5]**

enGene Holdings Provides Update on Lead Asset Detalimogene Voraplasmid and Financial Position

- enGene's lead asset, **detalimogene voraplasmid**, for **non-muscle invasive bladder cancer (NMIBC) with CIS, BCG-resistant**, has **hit its target enrollment** in its pivotal study.  **[1980845_2137672_0]** 
- Based on September 2024 data, detalimogene voraplasmid demonstrated a **71% CR rate anytime** and **good tolerability**.  **[1980845_2137672_1]** 
- The company anticipates a **data update in Q4 2025**, plans to **file a BLA in the second half of 2026**, and expects potential **approval in 2027**.  **[1980845_2137672_5]** 
- enGene is **well capitalized with over $250 million in cash**, providing a runway **into 2027** based on current plans.  **[1980845_2137672_5]** 
- To prepare for potential launch, enGene has added **three board members** with commercial launch experience and a **Chief Global Commercialization Officer**.  **[1980845_2137672_4]**

enGene Holdings (ENGN)