enGene Therapeutics Inc. — Third Quarter 2026 Earnings Summary

Financial Performance

• Total operating expenses for the three months ended July 31, 2026, were $34.0 million, compared to $29.9 million for the same period in 2025.
• Research and development expenses decreased by $2.5 million to $20.1 million, driven by timing of process validation manufacturing activities, partially offset by workforce reduction-related costs.
• General and administrative expenses increased by $6.6 million to $13.9 million, primarily driven by workforce reduction-related costs and the annualization of personnel-related costs.
• Net loss attributable to common shareholders was approximately $32.5 million ($0.47 per share) for the three months ended July 31, 2026, compared to $29.0 million ($0.57 per share) in the prior year period.
• Net loss for the nine months ended July 31, 2026, was $92.5 million ($1.34 per share), compared to $79.4 million ($1.56 per share) in the prior year period.
• Cash, cash equivalents, and marketable securities totaled $266.3 million as of July 31, 2026, up from $202.3 million as of October 31, 2025.
• Total assets were $288.3 million as of July 31, 2026, compared to $221.5 million as of October 31, 2025.
• Total liabilities were $58.0 million as of July 31, 2026, compared to $53.8 million as of October 31, 2025.
• Total shareholders' equity was $230.3 million as of July 31, 2026, compared to $167.7 million as of October 31, 2025.
• No revenue was reported for the period as the company is in the clinical stage.

Guidance and Future Outlook

• Data updates on key regulatory endpoints (Complete Response at any time and Duration of Response ≥ 12 months) and landmark CR rates from the LEGEND pivotal cohort are planned for the fourth quarter of 2026.
• A pre-Biologics License Application (BLA) meeting with the FDA is on track for the fourth quarter of 2026.
• Initiation of the BLA submission for detalimogene is planned for the fourth quarter of 2026.
• Potential FDA approval decision for detalimogene and platform designation is anticipated in 2027.
• Management expects to report updated data on key primary and secondary regulatory endpoints from Cohort 1 of the LEGEND trial in 4Q 2026.

Business Segments and Product Lines

• Detalimogene is the lead program, an investigational non-viral gene therapy for high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
• Detalimogene is being evaluated in the ongoing, open-label, multi-cohort Phase 2 LEGEND trial.
• Pivotal Cohort 1 consists of 125 patients with high-risk, BCG-unresponsive NMIBC with carcinoma in situ (CIS) and previously reported an interim 54% complete response (CR) rate at any time and a 3.2% progression rate to muscle-invasive disease.
• A new cohort (Cohort 4) incorporating a brief surfactant bladder rinse (polidocanol) with detalimogene is currently enrolling patients.
• Preclinical data indicates that pretreatment with polidocanol demonstrated a 10-fold increase in mean IL-12 expression in murine models and a nine-fold increase in a large mammal model.
• The Dually Derivatized Oligochitosan (DDX) platform is used to develop detalimogene, designed to overcome limitations of viral-based gene therapies.
• Detalimogene holds Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA.
• Detalimogene was selected for the FDA's Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program.

Market and Competitive Landscape

• NMIBC accounts for approximately 75%-80% of new bladder cancer diagnoses.
• Patients with high-risk NMIBC unresponsive to BCG face 50%-70% disease recurrence rates and potential need for radical cystectomy.
• Market research indicates a future treatment paradigm where avoidance of radical cystectomy through sequencing multiple lines of therapy will become the norm.
• The prevalent population is expected to grow due to increased sequencing of therapies.
• A new market price point has been established by recently launched products.
• The company emphasizes the need for a product profile addressing workflow constraints in community urology practices.

Risks and Challenges

• Forward-looking statements regarding clinical efficacy, durability, safety, and regulatory approval are subject to numerous risks and uncertainties.
• There is no guarantee that detalimogene will successfully complete clinical development phases or achieve positive results in the pivotal cohort.
• Regulatory outcomes, including FDA decisions and feedback, may differ from expectations.
• Risks include the inability to predict final trial results from preliminary data, changes in trial results, and audit/verification procedures.
• Challenges include recruiting and retaining qualified personnel, establishing clinical trial sites, and enrolling patients.
• Actual results may differ materially from projections regarding expenses, debt obligations, capital requirements, and market acceptance.

Management Commentary and Tone

• CEO Ron Cooper stated the company's focus is on maturing regulatory endpoint data and engaging with the FDA regarding a BLA filing.
• Management believes detalimogene's clinical profile, tolerability, and office-based administration support its potential as an important treatment option for urologists and patients.
• Management expressed encouragement regarding the progress of the surfactant cohort, which aims to enhance efficacy and durability while preserving tolerability.
• The tone reflects confidence in the strong balance sheet and disciplined capital allocation to advance the program toward BLA submission and commercial readiness.
• Michael Heffernan assumed the role of Chairman of the Board in July 2026 to support commercial readiness and potential regulatory milestones.

Other Key Points

• A webinar on surfactant plus detalimogene preclinical data and cohort enrollment guidance is planned for October 15, 2026.
• A Key Opinion Leader (KOL) webinar regarding emerging NMIBC market insights was hosted on August 11, 2026, featuring Neal Shore, MD.
• The LEGEND trial includes four additional cohorts beyond the pivotal cohort: BCG-naïve patients (Cohort 2a), patients with inadequate prior BCG (Cohort 2b), patients with papillary-only disease (Cohort 3), and the surfactant cohort (Cohort 4).
• The company is well-capitalized with $266 million in cash and marketable securities to support continued capital discipline.
• Workforce reduction-related costs contributed to increases in both R&D and G&A expenses for the quarter.