enGene Reports Third Quarter 2024 Financial Results and Provides a Business Update

Rhea-AI Summary

enGene Holdings Inc. (Nasdaq: ENGN) reported its Q3 2024 financial results and provided a business update. The company, focused on developing detalimogene voraplasmid for high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), remains on track to release preliminary LEGEND study data in September 2024. Key financial highlights include:

- Cash and cash equivalents of $257.7 million, providing runway into 2027
- Total operating expenses of $16.8 million for Q3 2024
- Net loss of $14.1 million, or $0.32 per share

The company also announced leadership changes, including Ron Cooper joining as CEO and the promotion of Dr. Raj Pruthi to Chief Medical Officer.

Positive

• Strong cash position of $257.7 million, providing runway into 2027
• On track to release preliminary LEGEND study data in September 2024
• Key leadership appointments strengthening management team

Negative

• Increased net loss of $14.1 million compared to $6.0 million in Q3 2023
• Operating expenses increased to $16.8 million from $6.2 million in Q3 2023

Financial Analyst

enGene's Q3 2024 results reveal a strong financial position with $257.7 million in cash, providing runway into 2027. This substantial cash reserve is a positive indicator for investors, ensuring the company can fund its pivotal LEGEND study and operations without immediate financing concerns. The increased R&D expenses of $7.6 million reflect investment in the LEGEND study, signaling progress in their lead candidate, detalimogene voraplasmid. While the net loss widened to $14.1 million ($0.32 per share), this is expected for a clinical-stage biotech advancing its pipeline. The 171% year-over-year increase in operating expenses to $16.8 million warrants monitoring but is justified by clinical progression and public company expenses. Overall, enGene's financial health appears robust, supporting its near-term clinical milestones.

Oncology Researcher

The upcoming release of preliminary data from the LEGEND study's pivotal BCG-unresponsive cohort is a critical milestone for enGene. Detalimogene voraplasmid targets a significant unmet need in non-muscle invasive bladder cancer (NMIBC) patients who have failed BCG therapy. The potential for a non-viral gene therapy approach in this indication could be groundbreaking. The emphasis on practicality for both patients and urologists suggests a focus on real-world applicability, which could drive adoption if approved. The appointment of Dr. Raj Pruthi as CMO adds valuable clinical expertise to guide the development. However, investors should remain cautious as preliminary data, while important, may not fully predict the final study outcomes or regulatory success.

Market Research Analyst

enGene's focus on high-risk, BCG-unresponsive NMIBC represents a strategic targeting of a niche market with significant unmet needs. The global bladder cancer treatment market is projected to grow substantially and a novel therapy like detalimogene could capture a significant share if successful. The company's emphasis on ease of use and tolerability aligns with current trends in oncology care, potentially positioning the therapy favorably among urologists and patients. The recent leadership changes, including the appointment of Ron Cooper as CEO, bring valuable industry experience that could enhance market positioning and potential commercialization strategies. Investors should watch for the upcoming LEGEND study data as a key indicator of market potential and future valuation drivers.

Company remains on track to report preliminary LEGEND data in September 2024

Cash and cash equivalents of $257.7 million provide runway into 2027

BOSTON & MONTREAL--(BUSINESS WIRE)-- 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), announced its financial results for the third quarter ended July 31, 2024 and provided a business update.

“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.

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 voraplasmid, (also known as detalimogene, and previously EG-70) 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 registrational 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”, “intend”, “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: the timing and anticipated results of our current and future clinical trials, including preliminary results, beliefs as to the potential benefits of detalimogene, and the expected period over which enGene estimates its cash and cash equivalents will be sufficient to fund its 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” sections of the Company’s Annual Report on Form 10-K for the fiscal year ended October 31, 2023 and our Quarterly Reports on Form 10-Q for the fiscal quarters ended January 31, 2024, April 30, 2024 and July 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 Statements of Operations Information (unaudited) (Amounts in thousands of USD, except share and per share data)
		Three months ended July 31,								Nine months ended July 31,
			2024				2023				2024			2023
Operating expenses:
Research and development		$	11,549			$	3,901			$	27,042			$	10,787
General and administrative			5,210				2,347				17,800				4,831
Total operating expenses			16,759				6,248				44,842				15,618
Loss from operations			16,759				6,248				44,842				15,618
Total other (income) expense, net			(2,582	)			(1,528	)			(4,961	)			1,802
Net loss before provision for income tax			14,177				4,720				39,881				17,420
Provision for (benefit from) income taxes			(29	)			—				(38	)			—
Net loss		$	14,148			$	4,720			$	39,843			$	17,420
Deemed dividend attributable to redeemable convertible preferred shareholders			—				1,273				—				3,726
Net loss attributable to common shareholders, basic and diluted			14,148				5,993				39,843				21,146
Weighted-average common shares outstanding, basic and diluted			44,168,986				701,323				35,564,767				687,188
Net loss per share of common shares, basic and diluted		$	0.32			$	8.55			$	1.12			$	30.77

enGene Holdings Inc. Condensed Consolidated Balance Sheet Information (unaudited) (Amounts in thousands of USD)
		July 31, 2024				October 31, 2023
Cash and cash equivalents		$	257,678			$	81,521
Total assets			266,879				86,959
Total liabilities			36,550				14,473
Total shareholders’ equity (deficit)			230,329				72,486

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20240910212228/en/

For media contact: media@engene.com 

For investor contact: investors@engene.com 

Source: enGene Holdings Inc.

FAQ

What are enGene's (ENGN) Q3 2024 financial results?

enGene reported a net loss of $14.1 million, or $0.32 per share, with total operating expenses of $16.8 million for Q3 2024. The company had $257.7 million in cash and cash equivalents as of July 31, 2024.

When will enGene (ENGN) release preliminary data from the LEGEND study?

enGene expects to release preliminary data from the LEGEND study's pivotal BCG-unresponsive cohort by the end of September 2024.

What is enGene's (ENGN) lead investigational product?

enGene's lead investigational product is detalimogene voraplasmid, a non-viral genetic medicine being studied for high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis).

How long does enGene (ENGN) expect its current cash to last?

enGene expects its existing cash and cash equivalents of $257.7 million to fund operating expenses, debt obligations, and capital expenditures into 2027.