enGene secures $125 million expanded debt facility with Hercules Capital

enGene Holdings Inc. (NASDAQ: ENGN) entered into an amended loan agreement with Hercules Capital Inc. (NYSE: HTGC) for up to $125 million in debt financing, the clinical-stage genetic medicines company announced.

The company received $25 million at closing to refinance its existing debt facility. An additional $100 million remains available through multiple tranches, subject to achieving clinical, regulatory and commercial milestones for its bladder cancer treatment candidate detalimogene voraplasmid.

Three term loan tranches totaling up to $75 million can be drawn at enGene's discretion upon meeting specified milestones. A final $25 million tranche may be available at Hercules Capital's discretion upon the company's request. The principal amount and accrued interest must be repaid by January 1, 2030, with possible extensions.

enGene plans to file a Biologics License Application with the FDA for detalimogene in the second half of 2026 as a treatment for high-risk, BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.

"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," said Ron Cooper, enGene's president and chief executive officer.

Detalimogene is currently being evaluated in the Phase 2 LEGEND trial, which includes a pivotal cohort of 125 patients with high-risk, BCG-unresponsive NMIBC. The treatment has received Regenerative Medicine Advanced Therapy and Fast Track designations from the FDA.

The drug candidate was developed using enGene's Dually Derivatized Oligochitosan platform, designed as a non-viral gene therapy approach for bladder instillation to generate localized immune responses against tumors.

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