Engene Holdings Inc. has announced an expanded $125 million debt facility with Hercules Capital, Inc., providing additional financial flexibility to advance its detalimogene development and commercialization for bladder cancer. The company has received an initial $25 million at the close of the amendment to refinance existing debt and has the potential to draw up to $100 million in additional loan proceeds at its option, subject to achieving certain clinical, regulatory, and commercial milestones.
Engene's president and CEO, Ron Cooper, highlighted the significance of this additional capital in strengthening the company's balance sheet as it prepares for a planned biologics license application to the U.S. Food and Drug Administration for detalimogene in the second half of 2026, with a potential commercial launch in 2027.
Detalimogene voraplasmid is a novel, investigational, non-viral gene therapy designed for patients with high-risk, non-muscle invasive bladder cancer, including bacillus Calmette-Guérin (BCG)-unresponsive disease. It has received regenerative medicine advanced therapy and fast track designations from the FDA based on its potential to address the high unmet medical need for patients with BCG-unresponsive carcinoma in situ NMIBC with or without resected papillary tumors who are unable to undergo cystectomy.
Engene's lead program, detalimogene, is being evaluated in the ongoing multi-cohort Legend phase 2 trial, and the company aims to create new ways to address diseases with high clinical needs through mainstreaming gene therapy.
This expanded debt facility with Hercules Capital, Inc. provides Engene with the financial resources necessary to advance its innovative therapies, strengthen its position in the market, and potentially bring much-needed treatment options to patients in the near future. As a result of these announcements, the company's shares have moved 0.98% on the market, and are now trading at a price of $9.31. For the full picture, make sure to review enGene's 8-K report.
