CAD$191 million gross proceeds from the transaction to support the advancement of the clinical program and pipeline expansion
Pivotal clinical trial for lead program EG-70 targeting BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) currently enrolling patients
Lumira Ventures portfolio company enGene Holdings Inc., (“enGene” or the “Company”), a clinical-stage biotechnology company developing genetic medicines, has completed a business combination with a special purpose acquisition company and a concurrent oversubscribed private investment in public equity (PIPE) financing. As a result of this combination, enGene has become a publicly traded company whose shares are now listed on the Nasdaq market under the symbol “ENGN.” Gross proceeds from this transaction totaled approximately CAD$191 million.
With operations in Montréal and Boston, enGene is currently enrolling patients in a pivotal trial of its lead program EG-70 (detalimogene voraplasmid) in patients with BCG-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ. EG-70 was developed using the company’s proprietary Dually Derivatized Oligochitosan (DDX) platform, which enables a carrier to penetrate mucosal tissue and deliver a wide range of sizes and types of cargo, including DNA and various forms of RNA, by turning mucosal cells into therapeutic production “factories” that generate proteins and RNAs for a desired local effect.
“We are extremely proud of the progress enGene has made since our foundational investment in the company in 2015 via our Merck Lumira Biosciences Fund,” stated Peter van der Velden, Managing General Partner of Lumira Ventures. “That fund focused on identifying and building transformative biotechnology companies in Quebec, and enGene is certainly fulfilling that promise. Our commitment to the company runs deep and we are pleased to have provided the continuity of capital that is so critical for success in our sector, via investments in enGene from multiple Lumira-managed funds, including most recently via Lumira Ventures Fund IV’s participation in the PIPE transaction.”
“Lumira Ventures financial support and strategic guidance have been critical to enGene’s ability to develop our therapeutic platform, build a world-class team, and complete this important transaction,” said Jason Hanson, Chief Executive Officer of enGene. “We now look forward to advancing our shared mission to expand genetic medicine into the mainstream of clinical practice and address the high disease burden faced by patients in our areas of focus.”
Gerry Brunk, Managing Director of Lumira Ventures and enGene board member, added: “We extend our appreciation to the entire enGene management team and board in achieving this important milestone, as well as to our longtime enGene co-investors, Fonds de solidarité FTQ and Forbion. We also note the support of this transaction by other Lumira limited partners Northleaf Capital Partners, Investissement Québec, and other new investors including BVF Partners, Omega Funds, Cowen Healthcare Investments, and Vivo Capital.”
Based on data from Pitchbook and the CVCA, we believe enGene’s entry onto the Nasdaq exchange represents the first Canadian biotechnology company to debut in the public markets since 2020. We also believe that the company’s oversubscribed PIPE is the largest equity financing for a private or public Canadian biotechnology company in 2023.
For complete details on this transaction, please visit this link.
About Lumira Ventures
Founded in 2007, Lumira Ventures is a multi-stage life sciences investment firm with offices in Toronto, Montréal, Vancouver, and Boston. We partner with mission-driven entrepreneurs building companies that harness rapidly evolving advancements in medicine to develop transformative products for patients while delivering strong financial returns for our investors and meaningful economic value and impact for society. For more information, visit www.lumiraventures.com
About enGene
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. For more information, visit www.enGene.com.
Forward-Looking Statements
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 or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. 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 (or the negative versions of such words or 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: enGene’s expected future business plans and expansion of gene therapy into clinical practice; the potential benefits of the DDX platform and the future results and timing of Phase 1 and Phase 2 studies; the expected use of net proceeds of the Business Combination and the associated private funding; the effectiveness and use cases of enGene’s EG-70 Program; the expected timeline for the interim Phase 2 results from the EG-70 program. Readers are cautioned that forward-looking statements are not guarantees of future performance and that actual results or developments may differ materially from those expressed or implied in the forward-looking statements.
All forward-looking statements, including, without limitation, our examination of historical operating trends, are based upon our current expectations and various assumptions. Certain assumptions made in preparing the forward-looking statements include 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 is able to enroll a cohort of patients in the Phase 2 LEGEND trial to assess EG-70’s efficacy and safety in the BCG-naïve patient population to evaluate its ultimate potential as a monotherapy in first line patients and expanding EG-70’s opportunity; the Company is able to file a Biologics License Application in 2025 with the FDA for approval to market EG-70 in the United States as a monotherapy to treat BCG-unresponsive NMIBC; EG-70’s product profile can be integrated seamlessly into community urology clinics where the vast majority of NMIBC patients are treated; the Company is able 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 is able to execute the “pipeline-in-a-product” development strategy for EG-70; and the Company is able to utilize the dually derived chitosan gene delivery platform to develop effective, new agents for the delivery of genetic medicines to mucosal tissues.
All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those that we expected and/or those expressed or implied by such forward-looking statements. These risks and uncertainties include: the expected benefits of the Business Combination; enGene’s financial performance following the Business Combination, including financial projections and business metrics and any underlying assumptions thereunder; the ability to maintain the listing of enGene securities on Nasdaq following the Business Combination; enGene’s success in recruiting and retaining, or changes required in, officers, key personnel or directors following the completion of the Business Combination; enGene’s plans and ability to execute product development, manufacturing process development, preclinical and clinical development efforts successfully and on anticipated timelines; enGene’s ability to design, initiate and successfully complete clinical trials and other studies for its product candidates and its plans and expectations regarding its ongoing or planned clinical trials; enGene’s plans and ability to obtain and maintain marketing approval from the U.S. Food and Drug Administration and other regulatory authorities, including the European Medicines Agency, for its product candidates; enGene’s plans and ability to commercialize its product candidates, if approved by applicable regulatory authorities; the degree of market acceptance of enGene’s product candidates, if approved, and the availability of third-party coverage and reimbursement; the ability of enGene’s external contract manufacturers to support the manufacturing, release testing, stability analysis, clinical labeling and packaging of enGene’s products; enGene’s future financial performance and the sufficiency of enGene’s cash and cash equivalents to fund its operations; the outcome of any known and unknown litigation and regulatory proceedings; enGene’s ability to implement and maintain effective internal controls; or other risks and uncertainties detailed in filings with Canadian securities regulators on SEDAR+ and U.S. Securities and Exchange Commission on EDGAR.
Any forward-looking statement speaks only as of the date on which it was 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 disclaim 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. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made.