enGene Holdings, a clinical-stage developer of non-viral genetic medicines, said it has expanded its debt facility with Hercules Capital to up to $125 million, adding what the company described as non-dilutive financing as it prepares for a planned U.S. regulatory submission for its lead program, detalimogene voraplasmid, in high-risk, BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.
The company said it amended its loan and security agreement with Hercules, acting as agent, and two enGene subsidiaries. enGene plans to use the expanded facility to strengthen its balance sheet ahead of an expected Biologics License Application filing with the U.S. Food and Drug Administration in the second half of 2026. The company also pointed to a potential commercial launch in 2027 if the therapy is approved.
Under the amended agreement, enGene drew $25 million at signing and said the proceeds will be used to refinance its existing debt facility. The company may access three additional term loan tranches totaling up to $75 million, subject to achieving certain clinical, regulatory, and commercial milestones. A final tranche of up to $25 million may be made available at enGene’s request and at Hercules’ discretion. The company said outstanding principal and accrued but unpaid interest are due on or before January 1, 2030, unless the maturity date is extended under the agreement’s terms.
enGene’s lead asset, detalimogene, is an investigational, non-viral gene therapy designed for intravesical administration intended to drive a localized anti-tumor immune response in high-risk NMIBC, including BCG-unresponsive disease. The company said the therapy has received FDA Regenerative Medicine Advanced Therapy and Fast Track designations, and has been selected for the agency’s Chemistry, Manufacturing, and Controls Development and Readiness Pilot program.
Detalimogene is being evaluated in the ongoing open-label, multi-cohort Phase 2 LEGEND trial. enGene said the pivotal cohort includes 125 patients with high-risk, BCG-unresponsive NMIBC with carcinoma in situ, with or without papillary disease, and is intended to support the planned BLA. Additional cohorts are studying patients who are BCG-naïve, those exposed to BCG but without adequate treatment, and those with papillary-only BCG-unresponsive high-risk disease, with enrollment across the U.S., Canada, Europe, and Asia-Pacific.
KEY QUOTES:
“This additional access to capital strengthens our balance sheet and provides us financial flexibility as we plan for a BLA filing for detalimogene in the second half of this year and potential commercial launch in 2027. We’re pleased to continue our partnership with Hercules to achieve our goal of bringing detalimogene to patients with NMIBC in need of innovative, bladder-sparing treatment options.”
Ron Cooper, President and Chief Executive Officer, enGene
“Hercules is proud to support enGene on its mission to improve the lives of people living with bladder cancer. Our increased commitment underscores our approach as long-term capital partners to our portfolio companies and reflects our dedication to financing innovative life sciences companies through development and into commercialization.”
Bryan Jadot, Senior Managing Director, Hercules Capital
