enGene Holdings Inc., a clinical stage biotechnology company focused on non viral genetic medicines, has announced an expanded financing arrangement that could provide access to as much as 125 million US dollars. The Nasdaq listed company confirmed that it amended its existing loan and security agreement with Hercules Capital Inc., alongside two of its subsidiaries. The additional funding is intended to reinforce enGene’s financial position as it prepares for a planned Biologics License Application submission to the US Food and Drug Administration for its lead therapy, detalimogene voraplasmid, in the second half of 2026. The company is also positioning itself for a potential commercial launch of the therapy pending regulatory approval.
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The revised agreement gives enGene access to non dilutive capital that strengthens its balance sheet at a critical stage of development. According to the company, the funding will support regulatory activities tied to the upcoming BLA filing and help ensure operational readiness should detalimogene move toward commercialization. The therapy is being developed for patients with high risk, Bacillus Calmette Guérin unresponsive non muscle invasive bladder cancer with carcinoma in situ, a population with limited bladder sparing treatment options.
Ron Cooper, President and Chief Executive Officer of enGene, said the expanded financing provides greater flexibility as the company approaches important regulatory and commercial milestones. He noted that the additional capital allows enGene to prepare for its planned BLA submission later this year and supports longer term plans for a potential product launch in 2027. Cooper added that the company values its ongoing relationship with Hercules and sees the partnership as an important part of its effort to deliver innovative treatment options to patients with bladder cancer.
Hercules Capital also expressed confidence in enGene’s direction. Bryan Jadot, Senior Managing Director at Hercules, said the firm is pleased to continue supporting enGene as it advances its bladder cancer program. He explained that the increased commitment reflects Hercules’ strategy of acting as a long term capital partner to life sciences companies as they move from development toward commercialization, particularly those addressing serious unmet medical needs.
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Under the amended loan agreement, enGene received an initial 25 million dollars at closing, which will be used to refinance its existing debt facility. In addition, the company may access up to 75 million dollars across three future tranches, subject to the achievement of specific clinical, regulatory, and commercial milestones. A final tranche of up to 25 million dollars may also be made available at Hercules’ discretion. All outstanding principal and accrued interest under the agreement are scheduled to be repaid by January 1, 2030, unless the maturity date is extended in accordance with the agreement terms.
Non muscle invasive bladder cancer represents a substantial clinical and economic burden worldwide. In this disease, cancer cells are confined to the lining of the bladder and have not yet invaded the muscle wall. The condition may appear as papillary tumors that can often be surgically removed or as carcinoma in situ, which involves flat lesions that are more difficult to treat. Approximately three quarters of newly diagnosed bladder cancer cases fall into the NMIBC category. Patients with high risk disease who do not respond to standard BCG therapy face frequent recurrences and, in many cases, the prospect of bladder removal as the next treatment option.
Detalimogene voraplasmid is an investigational, non viral gene therapy designed for patients with high risk NMIBC, including those whose disease does not respond to BCG. The therapy is administered directly into the bladder and is intended to trigger a strong but localized immune response against tumor cells. It was developed using enGene’s proprietary Dually Derivatized Oligochitosan platform, which is designed to address several limitations associated with viral based gene therapies, including handling complexity, storage requirements, and manufacturing challenges.
The therapy has received both Regenerative Medicine Advanced Therapy and Fast Track designations from the US Food and Drug Administration. These designations are intended to accelerate the development and review of therapies that address serious conditions with unmet medical needs. Detalimogene has also been selected for participation in the FDA’s Chemistry, Manufacturing, and Controls Development and Readiness Pilot program, which supports therapies with the potential for earlier patient access.
Detalimogene is currently being evaluated in the Phase 2 LEGEND trial, an open label, multi cohort study designed to assess its safety and effectiveness in patients with high risk NMIBC. The pivotal cohort includes 125 patients with BCG unresponsive carcinoma in situ, with or without papillary disease, and is expected to form the basis of the planned BLA submission. Additional cohorts in the study include patients who are BCG naïve, patients with limited prior BCG exposure, and those with papillary only disease. The LEGEND trial is actively enrolling patients across multiple regions, including North America, Europe, and the Asia Pacific.
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