On January 29, 2024 enGene Holdings Inc. (Nasdaq: ENGN) (or "enGene" or the "Company"), a clinical-stage genetic medicines company whose non-viral lead program is in a pivotal study for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), reported its financial results for the fiscal year ended October 31, 2023 and provided a corporate update (Press release, enGene, JAN 29, 2024, View Source [SID1234639693]).

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"During 2023, enGene made substantial progress advancing our lead program, EG-70 (detalimogene voraplasmid), in our ongoing pivotal-stage LEGEND study in BCG-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ. In addition, we were pleased to build out an accomplished leadership team and transition into a public company," said Jason Hanson, Chief Executive Officer of enGene. "Based on the highly differentiated attributes of our non-viral DDX genetic medicine platform, we believe that EG-70 may become a powerful and heavily utilized therapy in the practicing urologists’s armamentarium, providing both therapeutic benefits for patients as well as ease-of-use advantages as compared to existing NMIBC therapeutics and those in late-stage development. We continue to enroll patients in our pivotal study and look forward to reporting interim clinical results in mid-2024."

Ryan Daws, Chief Financial Officer of enGene commented: "Together with our $50M expanded debt facility with Hercules Capital, the financing transactions completed concurrent with the reverse merger provide support for the ongoing LEGEND study of EG-70 in BCG-unresponsive and BCG-naïve NMIBC patients with Cis, BLA-enabling activities, and additional clinical applications. The Company is in a strong financial position, with cash on hand expected to support operations into Q2 2025, beyond the anticipated completion of the interim EG-70 clinical data and additional expected corporate milestones."

Recent Business Highlights:

Public Company Launch and EG-70 Clinical Program Progress: On November 1, 2023, enGene Holdings Inc launched as a publicly traded company focused on developing non-viral gene therapies based on its novel and proprietary dually derived chitosan, or "DDX", gene delivery platform, which allows localized delivery of multiple gene cargos directly to mucosal tissues and other organs. The Company’s lead product candidate, EG-70, is an intravesically administered, non-viral, polymeric nanoparticle comprising a DNA plasmid encoding three genes designed to generate a local immune reaction in proximity to tumors. enGene is enrolling patients in a combined Phase 1/2 open label registrational study of EG-70, referred to as "LEGEND" (ClinicalTrials.gov identifier NCT04752722) with interim data expected mid-year.

Achieved Primary and Secondary Endpoints in Phase 1 Portion of LEGEND Study in NMIBC: The Phase 1 portion enrolled 22 BCG-unresponsive patients, exhibited an encouraging safety profile, a 3-month complete response rate of 68% and supported dose selection for the Phase 2 portion of the study.

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: enGene continued to invest in its senior leadership and add experienced members to its Board of Directors. On February 2, 2023, Alex Nichols, Ph.D., joined as President and Chief Operating Officer, on September 7, 2023, Richard Bryce, M.D. was hired as Chief Medical Officer and on November 29, 2023, Ryan Daws joined as Chief Financial Officer. Additionally, on December 19, 2023, Lota Zoth, CPA, was appointed to the Company’s Board of Directors and serves as the Company’s Audit Committee Chair.
Past and Upcoming Anticipated Milestones

Presented clinical data from LEGEND Phase 1 trial at 24th Annual Meeting of the Society of Urologic Oncology in November 2023.

Announce interim readout from the pivotal Phase 2 LEGEND study mid-2024.
Full Year 2023 Financial Results

Cash and cash equivalents, as of October 31, 2023, were $81.5 million, compared to $20.4 million as of October 31, 2022. The Company expects that its existing cash and cash equivalents will fund operating expenses and capital expenditures into the second quarter of 2025.

Full Year 2023

Total operating expenses were $26.0 million for 2023, compared to $19.4 million for 2022. Research and development expenses increased by $1.0 million, mainly due to increasing CMC and clinical costs relating to our pivotal EG-70 study. General and administrative expenses increased by $5.6 million, primarily driven by share-based compensation and professional fees associated with accounting and audit related fees.

For the full year 2023, net loss attributable to common shareholders was $104.7 million, or $151.22 per share, compared to $29.0 million, or $44.30 per share, for the same period in 2022. The increase in net loss is mainly attributed to the increase in other expense. In 2023, within other expense are non-cash charges of $80.7 million arising from fair value adjustments on our convertible debentures and related derivative liabilities and a loss on extinguishment upon conversion of our convertible debentures; partially offset by non-cash fair value gain of $10.8 million from the cancellation of Series C preferred share warrants liabilities upon the Reverse Recapitalization on October 31, 2023.