enGene Announces Q3 2024 Financial Results and Business Update

enGene Holdings Inc., a clinical-stage genetic medicines company, has reported its financial results for the third quarter ending July 31, 2024, and provided an update on its business operations. The company is primarily focused on developing treatments for high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis). Their lead investigational product, detalimogene voraplasmid—formerly known as EG-70—is currently undergoing a pivotal study.

Chief Executive Officer Ron Cooper emphasized the potential of detalimogene, describing it as a practical therapy for both patients and urologists. He highlighted its distinctive mix of clinical efficacy, tolerability, and ease of use. The company plans to share preliminary results from their pivotal LEGEND study by the end of September 2024.

In terms of corporate milestones, enGene made significant leadership changes in July 2024. Ron Cooper was appointed as Chief Executive Officer and joined the Board of Directors. Additionally, Dr. Raj Pruthi was promoted to Chief Medical Officer, further strengthening the company's leadership team.

Financially, enGene is in a strong position. As of July 31, 2024, the company had cash and cash equivalents totaling $257.7 million. This financial reserve is expected to support operational expenses, debt obligations, and capital expenditures through 2027.

For the three months ending July 31, 2024, enGene's total operating expenses were $16.8 million, a significant increase from $6.2 million for the same period in 2023. The rise in expenses was primarily driven by increased research and development costs, which went up by $7.6 million due to manufacturing and clinical expenses related to the pivotal LEGEND study. General and administrative expenses also saw an increase of $2.9 million, attributed mainly to higher personnel costs and insurance expenses.

Despite these increased expenses, enGene's financial outlook remains robust. The net loss attributable to common shareholders for the three months ending July 31, 2024, was approximately $14.1 million, or $0.32 per share, compared to $6.0 million, or $8.55 per share, for the same period in 2023. The increased net loss is mainly due to higher operating expenses, though this was partially offset by net interest income earned during the period.

enGene is dedicated to pioneering genetic medicines aimed at addressing high clinical needs, particularly through the delivery of therapeutics to mucosal tissues and other organs. Their leading program, detalimogene voraplasmid, is specifically designed for patients with Non-Muscle Invasive Bladder Cancer (NMIBC). This program is part of the ongoing multi-cohort LEGEND Phase 2 study, which includes a registrational cohort focusing on detalimogene's efficacy in BCG-unresponsive patients with carcinoma in situ (Cis).

The development of detalimogene is based on enGene's proprietary Dually Derivatized Oligochitosan (DDX) platform. This platform allows for the penetration of mucosal tissues and the delivery of various forms of DNA and RNA, thereby enabling a broad spectrum of therapeutic applications.

In summary, enGene Holdings Inc. is making significant strides in the field of genetic medicines. With a strong financial base and promising clinical developments, the company is well-positioned to make substantial contributions to the treatment of high-risk bladder cancer and potentially other diseases in the future.