On September 10, 2024 enGene Holdings Inc. (Nasdaq: ENGN, or "enGene" or the "Company"), a clinical-stage genetic medicines company whose non-viral lead investigational product detalimogene voraplasmid, (also known as detalimogene, and previously EG-70), is in an ongoing pivotal study in patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis), reported its financial results for the third quarter ended July 31, 2024 and provided a business update (Press release, enGene, SEP 10, 2024, View Source [SID1234646493]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Detalimogene was designed to be the most practical therapy for patients living with NMIBC and the urologists caring for them," said Ron Cooper, Chief Executive Officer of enGene. "We believe the unmet need for bladder cancer patients is significant and that detalimogene has the potential to offer a highly differentiated profile with a unique combination of clinical activity, tolerability, and ease of use. We look forward to sharing preliminary results from our pivotal LEGEND study later this month."
Anticipated Milestones and Strategic Corporate Updates
Release of preliminary data from LEGEND Cohort 1: The Company expects to release preliminary data from the LEGEND study’s pivotal BCG-unresponsive cohort by the end of September.
Key leadership hires and board additions: In July 2024, enGene announced that Ron Cooper joined the Company as Chief Executive Officer and member of the Board of Directors. The Company also announced the promotion of Dr. Raj Pruthi to Chief Medical Officer.
Third Quarter 2024 Financial Results
Cash and cash equivalents, as of July 31, 2024, were $257.7 million. The Company expects that its existing cash and cash equivalents will fund operating expenses, debt obligations and capital expenditures into 2027.
Three Months ended July 31, 2024
Total operating expenses were $16.8 million for the three months ended July 31, 2024, compared to $6.2 million for the three months ended July 31, 2023. Research and development expenses increased by $7.6 million, mainly due to increasing manufacturing and clinical costs related to our pivotal LEGEND study and headcount costs. General and administrative expenses increased by $2.9 million, primarily driven by headcount costs and other expenses driven by director and officer insurance expense as the Company scales its general and administrative function to support the operation of a public company.
For the three months ended July 31, 2024, net loss attributable to common shareholders was approximately $14.1 million, or $0.32 per share, compared to approximately $6.0 million, or $8.55 per share, for the same period for the three months ended July 31, 2023. The increase in net loss is mainly attributed to the increase in operating expenses partially offset by net interest income earned during the period.