enGene Holdings Inc. (Nasdaq: ENGN), a clinical-stage genetic medicines company, announced its financial results for the third quarter ending July 31, 2024, along with a business update. The company’s lead investigational product, detalimogene voraplasmid (formerly known as EG-70), is currently in a pivotal study targeting patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis).
Ron Cooper, CEO of enGene, highlighted the potential of detalimogene, stating, “Detalimogene was designed as a practical solution for both patients with NMIBC and the urologists treating them. With a growing need for innovative bladder cancer therapies, we believe detalimogene has a unique combination of clinical efficacy, tolerability, and ease of use. We look forward to sharing preliminary results from our pivotal LEGEND study later this month.”
Key Milestones and Strategic Updates:
- Preliminary LEGEND Study Results: The company expects to release early data from the LEGEND study’s pivotal BCG-unresponsive cohort by the end of September 2024.
- Leadership Updates: In July 2024, enGene appointed Ron Cooper as CEO and Board member, and Dr. Raj Pruthi was promoted to Chief Medical Officer.
Third Quarter 2024 Financial Summary:
- Cash Position: As of July 31, 2024, enGene held $257.7 million in cash and cash equivalents, which are expected to support operating expenses, debt obligations, and capital expenditures through 2027.
- Operating Expenses: Total operating expenses for the quarter were $16.8 million, up from $6.2 million during the same period in 2023. This increase was primarily driven by higher research and development costs due to manufacturing and clinical trials for the LEGEND study, as well as higher headcount expenses. General and administrative expenses also rose by $2.9 million, driven by increased staffing and insurance costs as the company scales to operate as a public entity.
- Net Loss: enGene reported a net loss of $14.1 million, or $0.32 per share, compared to a net loss of $6.0 million, or $8.55 per share, for the same period in 2023. The rise in net loss is largely attributed to higher operating expenses, offset slightly by interest income.
About enGene
enGene is a clinical-stage biotechnology company mainstreaming genetic medicines 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, and previously EG-70) 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 study, which includes a registrational cohort studying detalimogene in Bacillus Calmette-Guérin (BCG)-unresponsive patients with carcinoma in situ (Cis).
