On March 11, 2024 enGene Holdings Inc. (Nasdaq: ENGN or "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 non-muscle invasive bladder cancer (NMIBC), reported its financial results for the first quarter ended January 31, 2024 (Press release, enGene, MAR 11, 2024, https://www.prnewswire.com/news-releases/engene-reports-first-quarter-2024-financial-results-and-recent-corporate-progress-302085823.html [SID1234641033]).
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"This is an exciting time for the Company as we move closer to realizing our vision of mainstreaming genetic medicines to address diseases with high unmet clinical needs. EG-70 was designed from the ground up to achieve this vision as a readily scalable, easy to use product candidate without the onerous storage and handling requirements typical of viral approaches. Our previously announced Phase 1 data for EG-70 in BCG-unresponsive NMIBC demonstrated an encouraging safety profile and a 73% complete response rate at any time, which has garnered significant enthusiasm from patients, the urology community, and investors," said Jason Hanson, Chief Executive Officer of enGene. "We are proud to enter our second quarter as a public company with significant momentum, having raised $200 million from top tier investors in a private financing in February. With existing cash and cash equivalents expected to fund the current operating plan into 2027, we believe enGene is well-positioned to complete the ongoing pivotal-stage LEGEND study of EG-70 in BCG-unresponsive NMIBC, execute on our plan to file our BLA in the first quarter of 2026, and pursue pipeline expansion via additional EG-70 development opportunities and potential new R&D programs."
Recent Business Highlights:
Completed $200 Million Oversubscribed Private Placement: On February 20, 2024, enGene completed the private placement of 20 million common shares at a price per share of $10.00, representing a 31% premium over the closing price prior to pricing the transaction (the "February 2024 PIPE Financing"). The financing included participation from new and existing investors.
Expanded Hercules Capital Debt Facility: On December 22, 2023, enGene announced the expansion of its existing debt facility with Hercules to up to $50 million, subject to certain milestones, with $22.5 million advanced at closing, of which approximately $8.6 million was applied to refinance in full the term loans outstanding under the prior loan agreement with Hercules.
Key Leadership Hires, Board Additions and Succession Planning: enGene continued to build out its executive leadership with the appointment of Ryan Daws as Chief Financial Officer and Lee Giguere as Chief Legal Officer and Corporate Secretary. Additionally, Lota Zoth, CPA, was appointed to the Company’s Board of Directors and serves as the Company’s Audit Committee Chair.
On February 14, 2024, enGene announced that due to personal family and health reasons, Jason Hanson intends to resign from his role as Chief Executive Officer and a member of the Board of Directors upon the appointment of a successor CEO. The Board of Directors is conducting a search for his successor. Following the hiring of a new CEO, Mr. Hanson will support the Company and the new CEO as a strategic advisor.
Anticipated Milestones and Corporate Updates
Announce a new indication and development plans for EG-70 in the first half of 2024.
Interim data readout from the ongoing pivotal Phase 2 LEGEND study of EG-70 in BCG-unresponsive NMIBC with carcinoma-in-situ (Cis) in mid-2024.
Initial efficacy data from the ongoing Phase 2 LEGEND study in a BCG-naive NMIBC cohort in the second half of 2024.
First Quarter 2024 Financial Results
Cash and cash equivalents, as of January 31, 2024, were $85.6 million, compared to $81.5 million as of October 31, 2023. The Company expects that its existing cash and cash equivalents together with the recent net proceeds of $187.5 million from its February 2024 PIPE Financing will fund operating expenses and capital expenditures into 2027.
Three Months ended January 31, 2024
Total operating expenses were $10.8 million for the three months ended January 31, 2024, compared to $4.6 million for the three months ended January 31, 2023. Research and development expenses increased by $2.0 million, mainly due to increasing CMC and clinical costs related to our pivotal EG-70 study. General and administrative expenses increased by $4.2 million, primarily driven by headcount costs and professional fees such as legal, accounting and audit as the Company scales its G&A function to support the operation of a public company.
For the three months ended January 31, 2024, net loss attributable to common shareholders was $10.7 million, or $0.46 per share, compared to $8.6 million, or $13.29 per share, for the same period for the three months ended January 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.