enGene, a clinical-stage, non-viral genetic medicines company, entered into an amendment to an amended and restated loan and security agreement with two of its subsidiaries and Hercules Capital as agent for up to $125 million.
Access to the additional non-dilutive capital strengthens enGene’s balance sheet in preparation for its planned Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for detalimogene voraplasmid as a treatment for high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) in Q2/26, and the potential commercial launch of detalimogene should it receive FDA approval.
“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,” Ron Cooper, president and CEO of enGene, said. “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.”
Bryan Jadot, senior managing director of Hercules, said, “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.”
Under the terms of the loan agreement, $25 million was funded on the execution of the amendment and will be used to refinance the company’s existing debt facility. Three additional term loan tranches totaling up to $75 million can be drawn at enGene’s option subject to the achievement of certain clinical, regulatory and commercial milestones. The final term loan tranche of up to $25 million may be made upon request of the company and at the discretion of Hercules. Under the terms of the loan agreement, the principal amount outstanding and all accrued but unpaid interest under the loan agreement shall be repaid on or before Jan. 1, 2030 (or such later dates as to which the maturity date may be extended from time to time in accordance with the terms of the loan agreement).
