enGene Reports Second Quarter 2025 Financial Results and Provides Business Update
'We have seen strong enrollment in the pivotal cohort of our LEGEND study,' said Ron Cooper, Chief Executive Officer of enGene. 'This positions us to stay on track for our planned trial updates across all cohorts in the second half of 2025 and a potential BLA filing in mid-2026, advancing our goal to introduce a novel, non-viral therapy that could redefine treatment for patients with high-risk non-muscle invasive bladder cancer.'
Recent Corporate Updates
Key executive hires and management appointments: In May 2025, the Company announced the appointment of Amy Pott as Chief Global Commercialization Officer. Ms. Pott joined enGene from Astellas Pharma, where she most recently served as Senior Vice President, Strategic Brand Marketing, Ophthalmics and Rare Diseases, and previously as Head of Commercial, Gene Therapies. She will serve as the Company's first dedicated executive for commercialization planning and execution.
LEGEND study enrollment update: Over the course of the first and second quarters of 2025, the Company expanded its clinical footprint for the LEGEND study with the addition of trial sites in Europe and Asia. The pivotal cohort evaluating detalimogene voraplasmid (also known as detalimogene, and previously EG-70) in high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) remains on track for our planned BLA in mid-2026. The Company expects to provide an update from LEGEND's pivotal cohort in the second half of 2025.
European Medicines Agency (EMA) Scientific Advice: The Company shared detalimogene preclinical and clinical data through the EMA Scientific Advice process. During the dialogue, EMA indicated that it broadly agrees that these data could be suitable for a Conditional Marketing Authorization Application (CMA) submission for detalimogene in BCG-unresponsive NMIBC with CIS assuming a positive benefit-risk ratio.
BIOTECanada Gold Leaf Biotech Company of the Year Award Winner: The Biotech Company of the Year Award recognizes a company that is transforming the future of healthcare through groundbreaking advancements. The Company is proud and honored to be recognized with this distinction.
Second Quarter 2025 Financial Results
As of April 30, 2025, cash, cash equivalents and marketable securities were $251.5 million. The Company expects that its existing cash, cash equivalents and marketable securities will fund operating expenses, debt obligations and capital expenditures into 2027.
Three Months ended April 30, 2025
Total operating expenses were $27.1 million for the three months ended April 30, 2025, compared to $17.3 million for the three months ended April 30, 2024. Research and development expenses increased by $10.4 million, mainly due to increasing manufacturing and clinical costs related to our pivotal LEGEND study and personnel-related costs. General and administrative expenses decreased by $0.5 million, primarily driven by decreased reliance on professional services to support the Company's operation as a publicly traded company.
For the three months ended April 30, 2025, net loss attributable to common shareholders was approximately $25.8 million, or $0.51 per share, compared to approximately $15.0 million, or $0.38 per share, for the same period for the three months ended April 30, 2024. The increase in net loss is mainly attributed to the increase in operating expenses, partially offset by net interest income earned during the period.
About Non-Muscle Invasive Bladder Cancer (NMIBC)
Non-muscle invasive bladder cancer (NMIBC) is a disease that poses a significant burden on both patients and clinics and has a massive economic impact on our healthcare system. NMIBC occurs when cancer cells grow in the tissues that line the interior of the bladder, but the cancer has not yet penetrated the muscle of the bladder wall. NMIBC can take the form of papillary outgrowths from the bladder wall, which are typically resected, or carcinoma in situ (CIS), flat, multifocal lesions that are unable to be resected, and the two can co-occur. About 75-80% of new bladder cancer diagnoses are NMIBC. Patients suffering from high-risk NMIBC who are unresponsive to the standard of care, Bacillus Calmette-Guérin (BCG), face high rates of disease recurrence (50-70%) and are subject to full removal of the bladder (cystectomy) as a curative but life-altering next step.
About Detalimogene
Detalimogene is a novel, investigational, non-viral genetic medicine for patients with high-risk, NMIBC, including BCG-unresponsive disease. It is designed to be instilled in the bladder and elicit a powerful yet localized anti-tumor immune response.
Detalimogene was developed using the Company's Dually Derivatized Oligochitosan® (DDX) platform, a technology designed to transform how gene therapies are accessed by patients and utilized by clinicians. Medicines developed with the DDX platform can potentially overcome the limitations of viral-based gene therapies, simplify safe handling and cold storage complexities, and streamline both manufacturing processes and administration paradigms.
Detalimogene has received Fast Track designation from the U.S. Food and Drug Administration (FDA) based on its potential to address the high unmet medical need for patients with BCG-unresponsive CIS NMIBC, with or without resected papillary tumors, who are unable to undergo cystectomy. Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
About the Pivotal LEGEND Trial
Detalimogene is being evaluated in the ongoing, open-label, multi-cohort, Phase 2 LEGEND trial to establish its safety and efficacy in high-risk, NMIBC. LEGEND's pivotal cohort (Cohort 1) consists of approximately 100 patients with high-risk, BCG-unresponsive NMIBC with CIS (with or without papillary disease) and is designed to serve as the basis of the Company's planned Biologics License Application (BLA) filing. In addition to this pivotal cohort, LEGEND includes three additional cohorts, including NMIBC patients with CIS who are naïve to treatment with BCG (Cohort 2a); NMIBC patients with CIS who have been exposed to BCG but have not received adequate BCG treatment (Cohort 2b); and BCG-unresponsive high-risk NMIBC patients with papillary-only disease (Cohort 3). The LEGEND trial is actively enrolling patients with sites participating in the USA, Canada, Europe, and the Asia-Pacific region.
About enGene
enGene is a clinical-stage biotechnology company mainstreaming genetic medicines through the delivery of therapeutics to mucosal tissues and other organs, with the goal of creating new ways to address diseases with high clinical needs. enGene's lead program is detalimogene for patients with Non-Muscle Invasive Bladder Cancer (NMIBC) – a disease with a high clinical burden. Detalimogene is being evaluated in the ongoing multi-cohort LEGEND Phase 2 study, which includes a pivotal cohort studying detalimogene in Bacillus Calmette-Guérin (BCG)-unresponsive patients with carcinoma in situ (CIS). Detalimogene was developed using enGene's proprietary Dually Derivatized Oligochitosan (DDX) platform, which enables penetration of mucosal tissues and delivery of a wide range of sizes and types of cargo, including DNA and various forms of RNA. For more information, visit enGene.com.
Forward-Looking Statements
Certain statements contained in this press release may constitute 'forward-looking statements' within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, and 'forward-looking information' within the meaning of Canadian securities laws (collectively, 'forward-looking statements'). enGene's forward-looking statements include, but are not limited to, statements regarding enGene's management teams' expectations, hopes, beliefs, intentions, goals, or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words 'anticipate', 'appear', 'approximate', 'believe', 'continue', 'could', 'estimate', 'expect', 'foresee', 'intends', 'may', 'might', 'plan', 'possible', 'potential', 'predict', 'project', 'seek', 'should', 'would', and similar expressions (or the negative version of such words or expressions) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements may include, for example, statements about: our plans regarding the timing of our planned BLA submission to the Food and Drug Administration, our expectations as to the timing and anticipated results of the LEGEND study, including the timing of preliminary data or other updates, our expectations regarding a potential CMA submission to the EMA, our expectations regarding completion of enrollment in the LEGEND study, including the timing, the potential benefits of detalimogene, including its potential impact on the treatment landscape and attractiveness to patients and physicians, the potential benefits of medicines developed with the DDX platform and the expected period over which we estimate our cash, cash equivalents and marketable securities will be sufficient to fund our current operating plan.
Many factors, risks, uncertainties and assumptions could cause the Company's actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the Company's ability to recruit and retain qualified scientific and management personnel, establish clinical trial sites and enroll patients in its clinical trials, execute on the Company's clinical development plans and ability to secure regulatory approval on anticipated timelines, and other risks and uncertainties detailed in filings with Canadian securities regulators on SEDAR+ and with the U.S. Securities and Exchange Commission ('SEC') on EDGAR, including those described in the 'Risk Factors' section of the Company's Annual Report on Form 10-K for the fiscal year ended October 31, 2024 (copies of which may be obtained at www.sedarplus.ca or www.sec.gov).
You should not place undue reliance on any forward-looking statements, which speak only as of the date on which they are made. enGene anticipates that subsequent events and developments will cause enGene's assessments to change. While enGene may elect to update these forward-looking statements at some point in the future, enGene specifically disclaims any obligation to do so, unless required by applicable law. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved.
enGene Holdings Inc.
Condensed Consolidated Balance Sheet Information
(unaudited)
(Amounts in thousands of USD)
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EverGen Infrastructure Reports Q2 2025 Results
VANCOUVER, British Columbia--(BUSINESS WIRE)-- EverGen Infrastructure Corp. ('EverGen' or the 'Company') (TSXV: EVGN) (OTCQB: EVGIF), today reported financial results as at and for Q2 2025. All amounts are in Canadian dollars unless otherwise stated and have been prepared in accordance with IFRS. Strategic & Financing Updates $5 Million Private Placement: In May 2025, EverGen completed a $5 million non-brokered private placement of common shares with Ask America, LLC strengthening the Company's balance sheet. Debt Refinancing: The Company progressed refinancing of its Fraser Valley Biogas facility, with a signed letter of intent for a $13 million debt facility and $250,000 operating line of credit in February. EverGen expects to complete this refinancing in Q3 2025, with terms that are better aligned with the Company's current operations and strategic focus. Additional Equity Financing: Commitments and indications received for up to $2 million of additional proceeds pursuant to a second tranche of the private placement of common shares at a price of $0.60 per share. The Company has extended this tranche to close alongside the debt refinancing, anticipated in Q3 2025. In all other respects, the terms of the private placement and use of proceeds will remain as previously disclosed in the April 23, 2025, press release. The completion of the private placement is subject to customary closing conditions, including the approval of the TSX Venture Exchange (the "Exchange"). Operational Updates RNG Production Growth: RNG production increased 17% year-over-year setting a new quarterly record. In March and April 2025, FVB achieved over 12,000 gigajoules ('GJs') of monthly production and is now approaching a run-rate equal to the annual nameplate capacity of the facility of 160,000 GJ. Optimization Initiatives: With planned changes to senior leadership team complete, the Company initiated optimization activities across core facilities during Q2 2025. While these activities temporarily reduce incoming organic waste volumes and revenues, they are expected to unlock sustainable cash flow, future growth and underpin EverGen's position as a long-term RNG leader. Financial Results: Management Commentary 'Q2 2025 was a transformational quarter for EverGen as we successfully recapitalized the business, aligned our leadership with a supportive lead investor, and continued to deliver record RNG production,' said Chase Edgelow, CEO of EverGen. 'We're tracking well against our 100-day plan for the business, and while optimization activities will continue to impact near term revenues, these initiatives are critical to positioning EverGen for scalable growth in 2026 and beyond, reinforcing our long-term vision as Canada's leading RNG infrastructure platform.' Outlook With a stronger balance sheet, growing RNG output, and optimization initiatives underway, EverGen is positioned to deliver sustainable growth, enhance shareholder value, and advance its leadership in Canada's RNG sector. The Company expects to complete its refinancing and additional equity raise in Q3 2025, further strengthening its financial foundation. For further information on the results please see the Company's Consolidated Financial Statements and Management's Discussion and Analysis filed on SEDAR+ at and on EverGen's website at EverGen will hold a results and corporate update conference call at 11:00 a.m. Eastern Time on Friday, August 22, 2025, hosted by Chief Executive Officer, Chase Edgelow. Find the latest Corporate Presentation in the Investor Center: Market Maker Further, to support liquidity and trading of the Company's shares, EverGen has engaged Independent Trading Group ('ITG'), Inc. to assist in maintaining active and orderly trading in the market for the common shares of the Company on the TSX Venture Exchange (the "TSX-V"). The market-making service will be undertaken by ITG in compliance with the applicable policies of the TSX-V and other applicable laws. For its services, the Company has agreed to pay ITG a service fee of $6,000 with option to renew monthly. The Company and ITG act at arm's length. ITG, nor any of its principals, currently own any securities, directly or indirectly, of the Company. The engagement of ITG is subject to the Company making certain filings with the Exchange and acceptance by the Exchange. About EverGen Infrastructure Corp. EverGen, Canada's Renewable Natural Gas Infrastructure Platform, is combating climate change and helping communities contribute to a sustainable future. Headquartered on the West Coast of Canada, EverGen is an established independent renewable energy producer which acquires, develops, builds, owns, and operates a portfolio of Renewable Natural Gas, waste to energy, and related infrastructure projects. EverGen is focused on Canada, with continued growth expected across other regions in North America and beyond. For more information about EverGen Infrastructure Corp. and our projects, please visit Non-GAAP Measures EverGen uses certain financial measures referred to in this press release to quantify its results that are not prescribed by IFRS. The terms EBITDA, adjusted EBITDA and working capital are not recognized measures under IFRS and may not be comparable to that reported by other companies. EverGen believes that, in addition to measures prepared in accordance with IFRS, the non-IFRS measurement provide useful information to evaluate the Company's performance and ability to generate cash, profitability and meet financial commitments. These non-IFRS measures are intended to provide additional information and should not be considered in isolation or as a substitute for other measures of performance prepared in accordance with IFRS. EBITDA is defined as net income (loss) before interest, tax and depreciation and amortization. Adjusted EBITDA is EBITDA adjusted for share-based payment expenses, unusual or non-recurring items, contingent consideration gains and losses and non-controlling interests in adjusted EBITDA. Working capital is calculated as current assets less current liabilities. Forward-Looking Information This news release contains certain forward-looking statements and/or forward-looking information (collectively, 'forward looking statements') within the meaning of applicable securities laws. When used in this release, such words as 'would', 'will', 'anticipates', 'believes', 'explores', 'expects' and similar expressions, as they relate to EverGen, or its management, are intended to identify such forward-looking statements. More particularly, and without limitation, this press release contains forward looking statements and information concerning the Company's expectations regarding revenue growth and future financial or operating performance and the completion of a debt refinancing and a second tranche of the private placement, including the timing and amounts thereof. Such forward-looking statements reflect the current views of EverGen with respect to future events, and are subject to certain risks, uncertainties and assumptions., including the receipt of all approvals and satisfaction of all conditions to completion of the debt refinancing and the extension and completion of the private placement and the acceptance by the Exchange of the engagement of ITG. Many factors could cause EverGen's actual results, performance or achievements to be materially different from any expected future results, performance or achievement that may be expressed or implied by such forward-looking statements and, accordingly, no assurance can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do, what benefits EverGen will derive therefrom, and accordingly, readers are cautioned not to put undue reliance on the forward-looking statements contained in this press release. The Company cautions that these forward-looking statements are subject to numerous risks and uncertainties, including but not limited to: counterparty risk to closing the debt refinancing and the second tranche of the private placement; the impact of general economic conditions in Canada, including the current inflationary environment; industry conditions including changes in laws and regulations and/or adoption of new environmental laws and regulations and changes in how they are interpreted and enforced, in Canada; volatility of prices for energy commodities; change in demand for clean energy to be offered by EverGen; competition; lack of availability of qualified personnel; obtaining required approvals of regulatory authorities in Canada; ability to access sufficient capital from internal and external sources; optimization and expansion of organic waste processing facilities and RNG feedstock; the realization of cost savings through synergies and efficiencies expected to be realized from the Company's completed acquisitions; the sufficiency of EverGen's liquidity to fund operations and to comply with covenants under its credit facility; continued growth through strategic acquisitions and consolidation opportunities; continued growth of the feedstock opportunity from municipal and commercial sources, and the factors discussed under 'Risk Factors' in the Company's Annual Information Form dated April 22, 2024, which is available on SEDAR+ at many of which are beyond the control of EverGen. Forward-looking statements included in this news release should not be read as guarantees of future performance or results. The forward-looking statements contained in this release are made as of the date of this release, and except as may be expressly required by applicable law, EverGen disclaims any intent, obligation or undertaking to publicly release any updates or revisions to any forward-looking statements contained herein whether as a result of new information, future events or results or otherwise. This news release shall not constitute an offer to sell or the solicitation of an offer to buy the securities in any jurisdiction. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
