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enGene Reports First Quarter 2025 Financial Results and Provides Business Update

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enGene Holdings (Nasdaq: ENGN) reported Q1 2025 financial results and provided updates on its LEGEND study of detalimogene in BCG-unresponsive NMIBC. The company expanded trial sites into Europe and Asia, with all four LEGEND cohorts now open for enrollment. The study includes a new maintenance dosing protocol allowing complete responders to continue treatment for up to three years.

Financial highlights:

  • Cash position: $272.8 million, providing runway into 2027
  • Q1 2025 operating expenses: $26.6 million (vs $10.8 million in Q1 2024)
  • Net loss: $24.6 million ($0.48 per share)
  • R&D expenses increased by $14.3 million due to LEGEND study costs

The company remains on track for its planned Biologics License Application (BLA) filing in mid-2026, with additional preliminary data from the LEGEND study expected in H2 2025.

enGene Holdings (Nasdaq: ENGN) ha riportato i risultati finanziari del primo trimestre 2025 e ha fornito aggiornamenti sul suo studio LEGEND di detalimogene in NMIBC non responsivo al BCG. L'azienda ha ampliato i siti di sperimentazione in Europa e Asia, con tutti e quattro i gruppi LEGEND ora aperti per l'arruolamento. Lo studio include un nuovo protocollo di dosaggio di mantenimento che consente ai rispondenti completi di continuare il trattamento per un massimo di tre anni.

Risultati finanziari:

  • Posizione di cassa: 272,8 milioni di dollari, garantendo liquidità fino al 2027
  • Spese operative del Q1 2025: 26,6 milioni di dollari (rispetto a 10,8 milioni di dollari nel Q1 2024)
  • Perdita netta: 24,6 milioni di dollari (0,48 dollari per azione)
  • Le spese per R&S sono aumentate di 14,3 milioni di dollari a causa dei costi dello studio LEGEND

L'azienda rimane in linea con la sua pianificazione per la presentazione della domanda di licenza biologica (BLA) a metà 2026, con ulteriori dati preliminari dallo studio LEGEND attesi nella seconda metà del 2025.

enGene Holdings (Nasdaq: ENGN) informó los resultados financieros del primer trimestre de 2025 y proporcionó actualizaciones sobre su estudio LEGEND de detalimogene en NMIBC no responsivo a BCG. La compañía amplió los sitios de ensayo en Europa y Asia, con los cuatro cohortes de LEGEND ahora abiertos para inscripción. El estudio incluye un nuevo protocolo de dosificación de mantenimiento que permite a los respondedores completos continuar el tratamiento por hasta tres años.

Aspectos financieros destacados:

  • Posición de efectivo: 272,8 millones de dólares, proporcionando liquidez hasta 2027
  • Gastos operativos del Q1 2025: 26,6 millones de dólares (frente a 10,8 millones de dólares en el Q1 2024)
  • Pérdida neta: 24,6 millones de dólares (0,48 dólares por acción)
  • Los gastos de I+D aumentaron en 14,3 millones de dólares debido a los costos del estudio LEGEND

La compañía sigue en camino para su presentación de Solicitud de Licencia Biológica (BLA) a mediados de 2026, con datos preliminares adicionales del estudio LEGEND esperados para la segunda mitad de 2025.

enGene Holdings (Nasdaq: ENGN)는 2025년 1분기 재무 결과를 보고하고 BCG 비반응성 NMIBC에서 detalimogene에 대한 LEGEND 연구의 업데이트를 제공했습니다. 회사는 유럽과 아시아에 시험 사이트를 확장했으며, 이제 모든 네 개의 LEGEND 집단이 등록을 위해 열려 있습니다. 이 연구에는 완전 반응자가 최대 3년 동안 치료를 계속할 수 있도록 하는 새로운 유지 요법 프로토콜이 포함되어 있습니다.

재무 하이라이트:

  • 현금 보유: 2억 7280만 달러, 2027년까지 자금 확보
  • 2025년 1분기 운영 비용: 2660만 달러 (2024년 1분기 1080만 달러 대비)
  • 순손실: 2460만 달러 (주당 0.48달러)
  • R&D 비용은 LEGEND 연구 비용으로 인해 1430만 달러 증가

회사는 2026년 중반에 예정된 생물학적 제제 허가 신청(BLA) 제출을 위해 순조롭게 진행되고 있으며, 2025년 하반기에 LEGEND 연구의 추가 예비 데이터가 예상됩니다.

enGene Holdings (Nasdaq: ENGN) a publié ses résultats financiers du premier trimestre 2025 et a fourni des mises à jour sur son étude LEGEND concernant le detalimogene dans le NMIBC non réactif au BCG. L'entreprise a élargi les sites d'essai en Europe et en Asie, avec les quatre cohortes LEGEND maintenant ouvertes à l'inscription. L'étude comprend un nouveau protocole de dosage de maintenance permettant aux répondants complets de poursuivre le traitement pendant jusqu'à trois ans.

Points financiers clés :

  • Position de trésorerie : 272,8 millions de dollars, garantissant une liquidité jusqu'en 2027
  • Dépenses d'exploitation du T1 2025 : 26,6 millions de dollars (contre 10,8 millions de dollars au T1 2024)
  • Perte nette : 24,6 millions de dollars (0,48 dollars par action)
  • Les dépenses de R&D ont augmenté de 14,3 millions de dollars en raison des coûts de l'étude LEGEND

L'entreprise reste sur la bonne voie pour le dépôt de sa demande de licence biologique (BLA) prévu pour mi-2026, avec des données préliminaires supplémentaires de l'étude LEGEND attendues dans la seconde moitié de 2025.

enGene Holdings (Nasdaq: ENGN) hat die finanziellen Ergebnisse für das erste Quartal 2025 veröffentlicht und Updates zu seiner LEGEND-Studie zu detalimogene bei BCG-unresponsive NMIBC bereitgestellt. Das Unternehmen hat die Prüfstandorte nach Europa und Asien ausgeweitet, wobei alle vier LEGEND-Kohorten jetzt für die Einschreibung geöffnet sind. Die Studie umfasst ein neues Wartungsdosisprotokoll, das es vollständigen Ansprechern ermöglicht, die Behandlung bis zu drei Jahre fortzusetzen.

Finanzielle Höhepunkte:

  • Liquiditätsposition: 272,8 Millionen Dollar, die bis 2027 Spielraum bietet
  • Betriebskosten Q1 2025: 26,6 Millionen Dollar (gegenüber 10,8 Millionen Dollar im Q1 2024)
  • Nettoverlust: 24,6 Millionen Dollar (0,48 Dollar pro Aktie)
  • F&E-Ausgaben stiegen um 14,3 Millionen Dollar aufgrund der Kosten der LEGEND-Studie

Das Unternehmen bleibt auf Kurs für die geplante Einreichung des Antrags auf biologisches Lizenzverfahren (BLA) Mitte 2026, mit zusätzlichen vorläufigen Daten aus der LEGEND-Studie, die für die zweite Hälfte von 2025 erwartet werden.

Positive
  • Strong cash position of $272.8 million providing extended runway into 2027
  • Global expansion of LEGEND study with new sites in Europe and Asia
  • All four LEGEND study cohorts now open for enrollment
  • Implementation of maintenance dosing protocol to potentially improve treatment durability
Negative
  • Operating expenses more than doubled to $26.6 million in Q1 2025
  • Net loss increased to $24.6 million from $10.7 million year-over-year
  • R&D expenses significantly increased by $14.3 million

Insights

enGene's Q1 2025 results present a balanced picture typical of a clinical-stage biotech advancing its lead program. The company reported $26.6 million in operating expenses (146% increase year-over-year) and a net loss of $24.6 million, but these increased expenditures directly support the advancement of their pivotal LEGEND study for detalimogene voraplasmid in bladder cancer.

The company's robust cash position of $272.8 million provides runway into 2027, extending well beyond their planned mid-2026 BLA filing. This financial stability eliminates near-term funding concerns during this critical clinical development phase.

The LEGEND study's expansion into Europe and Asia represents meaningful operational progress. Opening all four cohorts for enrollment, including the pivotal cohort in high-risk BCG-unresponsive NMIBC with CIS, keeps the program on its critical path. The protocol amendment allowing maintenance dosing for complete responders is particularly significant as it could potentially enhance the therapy's durability while reducing treatment burden - a combination that would strengthen the commercial profile if approved.

The alignment of the study protocol with American Urological Association guidelines increases the likelihood of clinical adoption post-approval. With preliminary data expected in 2H 2025 and enrollment completion of the pivotal cohort anticipated this year, enGene has established clear near-term catalysts to demonstrate clinical progress.

While the increased operating expenses should be monitored, they reflect appropriate investment in a pivotal-stage asset approaching potential commercialization rather than a cause for concern.

Additional preliminary data from ongoing LEGEND study of detalimogene in BCG-unresponsive NMIBC with CIS, including pivotal cohort, anticipated in 2H 2025

Biologics License Application (BLA) filing planned for mid-2026 remains on track

Cash and marketable securities of $272.8 million expected to provide runway into 2027

BOSTON & MONTREAL--(BUSINESS WIRE)-- enGene Holdings Inc. (Nasdaq: ENGN, or “enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company, today announced its financial results for the first quarter ended January 31, 2025, and provided a business update.

“With the expansion of LEGEND study sites into Europe and Asia, enrollment in our pivotal cohort continues to track in-line with our plan to file a BLA for detalimogene in mid-2026,” said Ron Cooper, Chief Executive Officer of enGene. “We look forward to the remainder of 2025, during which we expect to announce enrollment completion of LEGEND’s pivotal cohort and provide additional updates on other LEGEND study cohorts. We continue to believe in detalimogene’s opportunity to transform the treatment landscape of NMIBC through a unique and differentiated overall profile that is highly attractive to both patients and physicians due to its potential for tolerability, ease-of-use, and efficacy.”

Recent Corporate Updates

LEGEND study trial site expansion: Over the course of the first quarter of 2025, the Company expanded its clinical footprint for the LEGEND study with the addition of trial sites in Europe and Asia. In addition, all four of LEGEND’s cohorts are now open for enrollment, including the pivotal cohort evaluating detalimogene voraplasmid (also known as detalimogene, and previously EG-70) in high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with CIS as well as Cohort 2a and 2b (i.e., NMIBC patients with CIS who are naïve to treatment with BCG and NMIBC patients with CIS who have been exposed to BCG, but have not received adequate BCG treatment), and Cohort 3 (BCG-unresponsive high-risk NMIBC patients with papillary-only disease). Global enrollment is taking place under an amended protocol that is designed to align with the American Urological Association’s current treatment guidelines and real-world practices.

LEGEND study now includes maintenance dosing: The amended LEGEND protocol allows patients from all cohorts who are in complete response at 12 months to continue receiving detalimogene on a dose-reduced maintenance schedule throughout their second year of treatment. At the end of year two, patients may elect to remain on maintenance therapy for another year, for a total of three years of therapy. Maintenance treatment consists of two instillations of detalimogene per three-month cycle, administered at week one and at week two of each cycle. The maintenance regimen is intended to evaluate the potential of longer-term detalimogene treatment to improve or maintain durability of response with the lower patient burden associated with a less frequent dosing regimen.

First Quarter 2025 Financial Results

As of January 31, 2025, cash, cash equivalents and marketable securities were $272.8 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 January 31, 2025

Total operating expenses were $26.6 million for the three months ended January 31, 2025, compared to $10.8 million for the three months ended January 31, 2024. Research and development expenses increased by $14.3 million, mainly due to increasing manufacturing and clinical costs related to our pivotal LEGEND study and headcount costs. General and administrative expenses increased by $1.5 million, primarily driven by increased headcount intended to support the Company’s operation as a publicly traded company.

For the three months ended January 31, 2025, net loss attributable to common shareholders was approximately $24.6 million, or $0.48 per share, compared to approximately $10.7 million, or $0.46 per share, for the same period for the three months ended January 31, 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 with a significant patient burden, high clinical needs, and 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 deeper into the muscle of the bladder wall. 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, non-muscle invasive bladder cancer (NMIBC), including Bacillus Calmette-Guérin (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 carcinoma in situ (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, non-muscle invasive bladder cancer (NMIBC). LEGEND’s pivotal cohort (Cohort 1) consists of approximately 100 patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive NMIBC with carcinoma in situ (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, three additional cohorts are actively enrolling patients, 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 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”, “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 completion of enrollment in the LEGEND study, including the timing, our expectations regarding the potential impact of the amendment of the LEGEND study protocol, 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 Statements of Operations Information

(unaudited)

(Amounts in thousands of USD, except share and per share data)

 

 

 

Three Months Ended January 31,

 

 

 

2025

 

 

2024

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

$

19,974

 

 

$

5,638

 

General and administrative

 

 

6,639

 

 

 

5,135

 

Total operating expenses

 

 

26,613

 

 

 

10,773

 

Loss from operations

 

 

26,613

 

 

 

10,773

 

Total other (income) expense, net

 

 

(2,015

)

 

 

(32

)

Net loss before income tax

 

 

24,598

 

 

 

10,741

 

Provision for (recovery of) income tax

 

 

18

 

 

 

(30

)

Net loss

 

$

24,616

 

 

$

10,711

 

Other comprehensive loss:

 

 

 

 

 

 

Unrealized gain on available-for-sale investments

 

$

(144)

 

 

$

 

Total comprehensive loss

 

$

24,472

 

 

$

10,711

 

Net loss attributable to common shareholders, basic and
diluted

 

 

24,616

 

 

 

10,711

 

Weighted-average common shares outstanding, basic and diluted

 

 

50,976,958

 

 

 

23,197,976

 

Net loss per share of common shares, basic and diluted

 

$

0.48

 

 

$

0.46

 

 

enGene Holdings Inc.

Condensed Consolidated Balance Sheet Information

(unaudited)

(Amounts in thousands of USD)

 

 

 

January 31,
2025

 

 

October 31, 2024

 

Cash, cash equivalents and marketable securities

 

$

272,792

 

 

$

297,859

 

Total assets

 

 

285,932

 

 

 

311,173

 

Total liabilities

 

 

35,982

 

 

 

38,561

 

Total shareholders’ equity

 

 

249,950

 

 

 

272,612

 

 

For media contact:

media@engene.com

For investor contact:

investors@engene.com

Source: enGene Holdings Inc.

FAQ

When will enGene (ENGN) file the BLA for detalimogene?

enGene plans to file the Biologics License Application (BLA) for detalimogene in mid-2026.

How long will enGene's (ENGN) current cash runway last?

The company's cash position of $272.8 million is expected to fund operations into 2027.

What is the new maintenance dosing protocol in the LEGEND study?

Patients in complete response at 12 months can receive reduced maintenance dosing for up to three years, with two instillations per three-month cycle.

How much did enGene (ENGN) lose per share in Q1 2025?

enGene reported a net loss of $0.48 per share in Q1 2025.

What caused the increase in enGene's (ENGN) R&D expenses in Q1 2025?

R&D expenses increased by $14.3 million due to higher manufacturing and clinical costs for the LEGEND study and increased headcount.
enGene Holdings Inc.

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