enGene Reports First Quarter 2026 Financial Results and Provides Business Update enGene (Nasdaq: ENGN) reported Q1 2026 results and provided a development update for detalimogene voraplasmid. Key highlights: $312.5 million cash and marketable securities providing runway into 2H 2028, expanded $125 million Hercules debt facility, and $140.1 million net proceeds from a Nov 2025 offering.LEGEND pivotal cohort showed promising efficacy (63% CR any time; 56% CR at 3 months; 62% CR at 6 months). enGene plans a BLA submission and expects 12-month data and a conference update in 2026.

#ENGN #HTGC enGene Reports First Quarter 2026 Financial Results and Provides Business Update

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enGene Announces Expanded $125 Million Debt Facility with Hercules Capital, Inc. enGene (Nasdaq: ENGN) amended its loan agreement with Hercules Capital to provide up to $125 million of debt financing, including $25 million funded at close and up to $100 million in additional tranches. The facility is non-dilutive, supports a planned BLA filing for detalimogene in H2 2026 and a potential commercial launch in 2027, and requires repayment of principal and accrued interest on or before January 1, 2030. Three $75 million of milestone-linked tranches and a discretionary final $25 million tranche complete the arrangement.

#ENGN #HTGC enGene Announces Expanded $125 Million Debt Facility with Hercules Capital, Inc.

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enGene Reports Full Year 2025 Financial Results and Provides Business Update enGene (Nasdaq: ENGN) reported full‑year 2025 results and a business update on December 22, 2025. Key operational highlights include completion of enrollment in the LEGEND pivotal cohort at 125 patients and preliminary post‑amendment 6‑month complete response (CR) rate of 62% (n=37). The company was selected for the FDA CDRP program to support CMC readiness and plans a BLA filing in 2H 2026 for detalimogene.Financially, enGene held $202.3M cash and marketable securities as of Oct 31, 2025 and raised $140.1M net in November, giving runway into 2H 2028. Full‑year operating expenses rose to $123.2M with a net loss of $117.3M (−$2.29/share).

#ENGN enGene Reports Full Year 2025 Financial Results and Provides Business Update

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enGene’s Detalimogene Selected for FDA Manufacturing Pilot Program to Support Manufacturing Readiness enGene (Nasdaq: ENGN) announced that the FDA selected detalimogene voraplasmid for the Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program to support CMC interactions ahead of a potential Biologics License Application.Detalimogene is an investigational non-viral gene therapy for high-risk, non-muscle invasive bladder cancer (NMIBC). The company says manufacturing has been scaled to commercial level and a BLA is planned for 2H 2026. Recent LEGEND pivotal-cohort data showed a 62% complete response rate at six months and safety data from 125 patients reported 42% treatment-related adverse events and 1.6% dose interruptions. Detalimogene holds RMAT and Fast Track designations.

#ENGN enGene’s Detalimogene Selected for FDA Manufacturing Pilot Program to Support Manufacturing Readiness

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enGene Announces Pricing of $130 Million Public Offering of Common Shares and Pre-Funded Warrants BOSTON& MONTREAL---- enGene Holdings Inc., a clinical-stage, non-viral genetic medicines company, today announced the pricing of its previously announced underwritten public offering of 12,558,823 common shares at a public offering price of $8.50 per share and pre-funded warrants to purchase 2,735,295 shares of its common shares at an offering price of...

#ENGN enGene Announces Pricing of $130 Million Public Offering of Common Shares and Pre-Funded Warrants

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#ENGN enGene Announces Proposed Public Offering of Common Shares

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Detalimogene Demonstrates Improved Complete Response Rate of 62% at 6 Months enGene (Nasdaq: ENGN) reported preliminary Phase 2 LEGEND pivotal-cohort data for detalimogene in high-risk, BCG-unresponsive NMIBC with CIS on November 11, 2025. Key interim results include a 63% complete response (CR) rate any time (N=62), 56% CR at 3 months (N=62), and 62% CR at 6 months (N=37). The Company completed pivotal enrollment at 125 patients, exceeding target by 25%.Safety was favorable: 42% experienced a treatment-related adverse event (mainly Grade 1/2), 1.6% had dose interruptions, and 0.8% discontinued for TRAEs. enGene plans a BLA filing in H2 2026 with potential approval in 2027.

#ENGN Detalimogene Demonstrates Improved Complete Response Rate of 62% at 6 Months

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100 Patients Enrolled: enGene's Breakthrough Bladder Cancer Gene Therapy Gains Special FDA Status Clinical-stage biotech enGene reaches full enrollment in pivotal LEGEND trial for bladder cancer therapy, secures RMAT designation. Q3 loss $28.9M with $224.9M cash runway into 2027.

#ENGN enGene Reports Third Quarter 2025 Financial Results and Provides Business Update

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100 Patients Enrolled: enGene's Groundbreaking Non-Viral Gene Therapy for High-Risk Bladder Cancer Hits Milestone Biotech firm enGene reaches 100-patient enrollment goal in pivotal LEGEND trial for non-viral gene therapy detalimogene in high-risk bladder cancer. Data update expected Q4 2025, BLA submission planned 2H 2026.

#ENGN enGene Achieves Target Enrollment Milestone for LEGEND Trial Pivotal Cohort

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enGene Adds FDA-Approved Therapy Veterans to Board as Gene Therapy Nears Commercial Stage Gene therapy leader enGene bolsters board with oncology and regulatory veterans as detalimogene advances. Three key promotions strengthen commercial readiness. See strategy.

#ENGN enGene Announces Board and Leadership Appointments to Support Commercial Readiness

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FDA Grants Special Status to Revolutionary Bladder Cancer Treatment - Major Win for Patients New bladder cancer immunotherapy receives FDA expedited review status. Promising clinical data shows potential breakthrough for patients with limited options. See trial results.

#ENGN FDA Grants RMAT Designation for enGene’s Detalimogene, Enabling Potential for Expedited Review in High-Risk, Non-Muscle Invasive Bladder Cancer

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enGene's Bladder Cancer Breakthrough Advances: Key Trial Updates and $251M War Chest Revealed in Q2 Earnings Latest LEGEND study data shows progress in BCG-resistant bladder cancer treatment. EMA signals support while $251M cash extends runway to 2027. See full trial timeline.

#ENGN enGene Reports Second Quarter 2025 Financial Results and Provides Business Update

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enGene Strengthens Leadership Team with Key Hire as Revolutionary Bladder Cancer Treatment Nears FDA Filing Former Astellas SVP Amy Pott joins as Commercial Chief to lead launch preparations for novel genetic medicine in bladder cancer. Learn strategic timing details.

#ENGN enGene Names Amy Pott as Chief Global Commercialization Officer

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enGene Reports Q1 Results: Strong Cash Position Funds Global Trial Expansion enGene advances LEGEND bladder cancer study with European and Asian expansion, backed by $273M cash runway through 2027. Key milestones include BLA filing and preliminary data in 2025-2026.

#ENGN enGene Reports First Quarter 2025 Financial Results and Provides Business Update

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enGene Reports Promising 71% Response Rate in Bladder Cancer Trial, Strong $298M Cash Position enGene's lead cancer therapy shows impressive efficacy in BCG-unresponsive NMIBC patients, with robust financial position extending operations through 2027.

#ENGN enGene Reports Full Year 2024 Financial Results and Provides a Business Update

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#ENGN enGene to Participate in Upcoming Investor Conferences

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