enGene (ENGN -3.50%), a clinical-stage gene therapy company advancing treatments for bladder cancer, released its fiscal 2025 third-quarter earnings on Sept. 11, 2025. The period was highlighted by key clinical and regulatory milestones, including reaching the target enrollment for its pivotal LEGEND trial cohort, and receiving Regenerative Medicine Advanced Therapy (RMAT) status from the Food and Drug Administration (FDA) for its lead therapy, detalimogene (EG-70).
Net losses more than doubled year over year, while operating expenses increased by approximately 78%, but the company reported a strong cash position expected to last into 2027. The absence of new clinical efficacy data and lack of explicit commercial guidance leave some open questions, but overall, the quarter brought notable progress at the clinical and regulatory levels.
| Metric | Q3 FY2025 | Q3 FY2024 | Y/Y Change |
|---|---|---|---|
| EPS | ($0.57) | ($0.32) | N/A |
| Revenue | $0 | $0 | — |
| Operating expenses | $29.9 million | $16.8 million | 78% |
| Net loss | $29.0 million | $14.1 million | 106% |
| Cash, cash equivalents and marketable securities | $224.9 million | — | — |
Source: enGene. Note: Fiscal 2025’s third quarter ended July 31, 2025. Fiscal 2024’s Q3 ended July 31, 2024.
About enGene: Fast-Moving Clinical Gene Therapy Business
enGene focuses on the research and development of gene therapies for urologic cancers, with a principal emphasis on non-muscle invasive bladder cancer (NMIBC). Its lead investigational therapy, detalimogene (EG-70), is a non-viral gene therapy intended to trigger a localized anti-tumor immune response in patients whose cancer has not responded to standard Bacillus Calmette-Guérin (BCG) treatment. As a relatively young company, having been founded in 2023, enGene has yet to generate product revenues and remains firmly in the clinical development phase.
The company’s strategy rests on successfully developing and eventually gaining approval for EG-70 for high-risk, BCG-unresponsive NMIBC. This focus reflects a critical unmet need in bladder cancer, particularly for patients with carcinoma in-situ who have limited treatment options. Key to success will be the therapy’s final clinical data, successful navigation of regulatory review, the ability to differentiate the product from other therapies, and readiness to scale and commercialize once approvals are achieved.
Quarter in Review: Trial Milestones, Regulatory Wins, and Costs on the Rise
During the quarter, enGene reached several critical development milestones for its lead product candidate. Most notably, it achieved full target enrollment for the pivotal cohort of its LEGEND study, specifically enrolling 100 patients with high-risk NMIBC carcinoma in-situ whose disease did not respond to BCG. Management confirmed that this sets up for a pivotal data update in the fourth quarter of 2025 and a planned Biologic License Application (BLA) filing in the second half of 2026. These steps align tightly with previous goals and management commentary.
The quarter also brought a significant regulatory achievement as detalimogene received Regenerative Medicine Advanced Therapy (RMAT) status from the Food and Drug Administration. RMAT designation confers regulatory advantages such as earlier and more frequent agency interactions, as well as the possibility of rolling submission and priority review. This follows an earlier Fast Track designation, together expediting the therapy’s path toward potential approval. While the company achieved these procedural milestones, the quarter did not include new disclosures related to efficacy or safety results from its trial. Management reiterated that updated clinical data should be available in late 2025.
On the financial front, Total operating expenses climbed sharply to $29.9 million, an increase of approximately 78% compared to the same period last year. The main drivers were an $11.0 million increase in research and development spending, driven by higher manufacturing and clinical trial costs as well as personnel expansion. General and administrative costs rose by $2.2 million, linked to workforce expansion and greater reliance on professional services in preparation for commercialization. Net loss also widened substantially, reflecting the increased investment required to advance the clinical and regulatory agenda for the three months ended July 31, 2025.
Supporting its organizational build, enGene made several senior-level hires in regulatory and clinical leadership roles. These hires underscore its preparations to transition from a pure research organization into one that can support regulatory filings and future commercial activity. However, detailed plans for manufacturing scalability and go-to-market structures have not been disclosed.
Product Platform and Strategic Focus
Detalimogene (EG-70) is a non-viral gene therapy, administered directly into the bladder to stimulate the immune system to fight cancer cells. The technology uses enGene’s Dually Derivatized Oligochitosan (DDX) platform, which aims to provide localized gene delivery without the use of viruses, potentially avoiding some risks and complexities associated with viral-based therapies. enGene highlights this approach as well-suited to minimizing storage and delivery barriers.
The company continues to focus resources on bringing detalimogene from late-stage clinical development through regulatory review. While enGene points to the high unmet medical need, it has not yet disclosed how its candidate compares against other agents on efficacy, safety, or overall patient outcomes, leaving market positioning an open question.
Looking Ahead: Upcoming Data and Financial Perspective
Management’s outlook centers on future milestones. enGene expects to report updated pivotal cohort data from its LEGEND trial in the fourth quarter of 2025, followed by a BLA regulatory submission in the second half of 2026. No formal guidance was provided about future operating expenses, revenue expectations, or other financial performance metrics.
The company noted that its $224.9 million in cash and marketable securities will fund operations, debt obligations, and capital expenditures into 2027. ENGN does not currently pay a dividend.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
Motley Fool Markets Team is a Foolish AI, based on a variety of Large Language Models (LLMs) and proprietary Motley Fool systems. The Motley Fool takes ultimate responsibility for the content of these articles. Motley Fool Markets Team cannot own stocks and so it has no positions in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.