On June 14, 2024 enGene Holdings Inc. (Nasdaq: ENGN, "enGene" or the "Company"), a clinical-stage genetic medicines company whose non-viral, intravesical lead product candidate, EG-70, is in a pivotal study for BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC), reported its financial results for the second quarter ended April 30, 2024, and provided a business update (Press release, enGene, JUN 14, 2024, View Source [SID1234644349]).
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"Our $200 million private placement in February positioned us well to execute our primary strategy of broadly developing EG-70 to be a patient- and practice-friendly option across a multitude of potential bladder cancer indications. Correspondingly, our planned initial expansion of the LEGEND study will include a cohort focused on enrollment of patients with high-risk, BCG-unresponsive papillary-only NMIBC, a disease with persistent unmet need for which EG-70 may be well-suited," said Jason Hanson, Chief Executive Officer of enGene. "Furthermore, we plan to provide the interim data for the LEGEND BCG-unresponsive cohort by the end of September 2024. We believe the design of EG-70, with its ease-of-use and non-viral profile, positions it well to seamlessly slot into the standard of care, with the goal of becoming a practice-changing product that does not require a change in practice for urologists."
Anticipated Milestones and Strategic Corporate Updates
Release of interim data from LEGEND Cohort 1: The Company expects to release interim data from the LEGEND study’s BCG-unresponsive cohort by the end of September, comprised of responses from approximately 20 patients focused on the three- and six-month time points. Study enrollment remains ongoing, and based on current projections, enGene expects to file a Biologics License Application (BLA) for EG-70 in mid-2026.
Commitment to expanding the clinical development of EG-70 within the bladder: Building on the design of EG-70 to have category-leading ease of use, scalable manufacturing process, and low cost-of-goods, the Company plans to explore additional applications of EG-70 within the bladder by expanding the LEGEND study to include a third cohort targeting high-risk BCG-unresponsive papillary-only NMIBC patients and modifying the second cohort (previously, the BCG-naïve cohort) to include BCG-exposed patients. Collectively, these potential indications represent an expansion into several areas of persistent unmet medical need with substantial patient populations. These clinical development plans include:
Papillary-only LEGEND expansion: The Company plans to expand LEGEND to enroll a third cohort of patients with BCG-unresponsive, papillary-only Ta/T1 disease. This cohort, whose target enrollment is 70-100 patients, is estimated to begin enrollment in the fourth quarter of 2024.
Modification of the second cohort of LEGEND study to separately analyze responses between BCG-naïve patients and BCG-exposed patients: In anticipation of this planned cohort modification and expected corresponding engagement with FDA, enrollment has been temporarily paused in this second cohort, with enrollment in both groups expected to resume in the fourth quarter of 2024.
As a result of the prioritization of these potential new indications in bladder cancer, the Company has deprioritized pre-clinical development of EG-i08 for cystic fibrosis and has paused further activities on that program.
Key leadership hires and board additions: In May 2024, enGene announced the election of Paul Hastings and Wouter Joustra as new members of its Board of Directors at the Company’s 2024 annual meeting of shareholders. Lota Zoth was also re-elected to the Board. Each will serve a three-year term expiring at the 2027 annual meeting of shareholders. enGene’s Board is comprised of seven members including Richard Glickman (Chairman), Gerald Brunk, Jasper Bos, and enGene CEO, Jason Hanson.
In April 2024, the Company announced that Raj Pruthi MD MHA FACS joined the Company as SVP, Urologic Oncology and Clinical Development. Dr. Pruthi joined enGene from Johnson & Johnson Innovative Medicine, where he was most recently the Global Medical Affairs Leader, Bladder Cancer and Senior Medical Director, Oncology (Global – Prostate and Bladder Cancer).
Second Quarter 2024 Financial Results
Cash and cash equivalents, as of April 30, 2024, were $264.8 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 April 30, 2024
Total operating expenses were $17.3 million for the three months ended April 30, 2024, compared to $4.7 million for the three months ended April 30, 2023. Research and development expenses increased by $6.6 million, mainly due to increasing manufacturing and clinical costs related to our pivotal EG-70 study. General and administrative expenses increased by $5.9 million, primarily driven by headcount costs and professional fees such as legal, accounting and audit as the Company scales its general and administrative function to support the operation of a public company.
For the three months ended April 30, 2024, net loss attributable to common shareholders was approximately $15.0 million, or $0.38 per share, compared to approximately $6.5 million, or $9.30 per share, for the same period for the three months ended April 30, 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.