BOSTON and MONTREAL, Dec. 22, 2023 /CNW/ – enGene Holdings Inc. (“enGene,” Nasdaq: ENGN), a clinical-stage genetic medicines company whose lead EG-70 program is in a pivotal study for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), announced today that it has entered into an amended USD $50 million loan agreement (the “Loan Agreement”) with Hercules Capital, Inc. (NYSE: HTGC) (“Hercules”). Under the Loan Agreement, which has a term of four years, $22.5 million has been advanced to enGene under a non-revolving term loan and, subject to certain clinical and financial milestones, up to a further $27.5 million in loan proceeds may be available subject to satisfaction of certain terms and conditions.
“We are thrilled to expand our relationship with Hercules Capital and obtain additional resources to support our development efforts,” said Jason Hanson, Chief Executive Officer of enGene. “We believe that EG-70 could transform how patients with BCG-unresponsive NMIBC are managed, and the proceeds from this term loan facility will further support the development of this program in BCG-unresponsive NMIBC and additional clinical applications. We expect that the capital obtained will meaningfully extend the Company’s cash runway, with cash supporting operations well beyond the anticipated EG-70 interim data readout.”
“Hercules Capital is pleased to collaborate once again with enGene as it advances EG-70 as an entirely new genetic medicine approach to treat NMIBC. This new, increased commitment from Hercules exemplifies 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,” said R. Bryan Jadot, Senior Managing Director and Group Head of Hercules Capital. The proceeds of the Term Loan Facility will be used for working capital and general corporate purposes of the Company, as well as to refinance enGene’s existing indebtedness under the original loan agreement with Hercules dated December 30, 2021.
Under the terms of the agreement, the principal amount outstanding and all accrued but unpaid interest under the Term Loan Facility shall be repaid on or before January 1, 2028 (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).
enGene is a clinical-stage biotechnology company mainstreaming genetic medicines through the delivery of therapeutics to mucosal tissues and other organs, with the goal of creating new ways to address diseases with high clinical needs. enGene’s lead program is EG-70 for patients with non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG) – a disease with a high clinical burden. EG-70 is being evaluated in an ongoing Phase 2 pivotal study. EG-70 was developed using enGene’s proprietary Dually Derivatized Oligochitosan (DDX) platform, which enables penetration of mucosal tissues and delivery of a wide range of sizes and types of cargo, including DNA and various forms of RNA. enGene became a publicly traded company effective November 1, 2023, upon the completion of a business combination with Forbion European Acquisition Corporation, a special purpose acquisition company. For more information, visit enGene.com.
Some of the statements contained in this press release may constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, and “forward-looking information” within the meaning of Canadian securities laws (collectively, “forward-looking statements”). enGene’s forward-looking statements include, but are not limited to, statements regarding enGene’s expectations, hopes, beliefs, intentions, goals, strategies, forecasts and projections. The words “anticipate”, “appear”, “approximate”, “believe”, “continue”, “could”, “estimate”, “expect”, “foresee”, “intend”, “may”, “might”, “plan”, “possible”, “potential”, “predict”, “project”, “seek”, “should”, “would”, and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements may include, for example, statements about: up to a further $27.5 million in loan proceeds being available subject to satisfaction of certain terms and conditions, enGene’s goal of mainstreaming gene therapy, and the near-term potential to have a meaningful impact in the lives of patients living with BCG-unresponsive NMIBC .
Many factors, risks, uncertainties and assumptions could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the Company’s ability to recruit and retain qualified scientific and management personnel, establish clinical trial sites and patient registration for clinical trials and acquire technologies complimentary to, or necessary for, its programs; the Company’s ability to address diseases with high clinical needs; the Company’s ability to retain commercial rights to EG-70 in the United States and commercialize EG-70 independently, while selectively partnering outside of the United States; the Company’s plans and ability to secure regulatory approval, to execute product development, manufacturing process development, preclinical and clinical development efforts successfully and on anticipated timelines; enGene’s ability to design mainstream gene therapy and bring genetic medicines to community clinics across the globe; and other risks and uncertainties detailed in filings with Canadian securities regulators on SEDAR+ and with the U.S. Securities and Exchange Commission (“SEC”) on EDGAR, including those described in the “Risk Factors” section of the Company’s Current Report on Form 8-K, filed with the SEC on October 31, 2023 (copies of which may be obtained at sedarplus.ca or www.sec.gov).
You should not place undue reliance on any forward-looking statements, which speak only as of the date on which they are made. enGene anticipates that subsequent events and developments will cause enGene’s assessments to change. While enGene may elect to update these forward-looking statements at some point in the future, enGene specifically disclaims any obligation to do so, unless required by applicable law. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved.
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