AI Earnings Predictions for enGene Holdings Inc. (ENGN)

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Exhibit 99.1

enGene Reports Second Quarter 2026 Financial Results and Provides Business Update

12-month complete response data from LEGEND pivotal cohort and subsequent FDA engagement planned for 2H 2026

Initiation of Biologics License Application (BLA) filing for detalimogene planned for 2H 2026

First patients enrolled in surfactant plus detalimogene cohort

Approximately 50% reduction in force to streamline operations and preserve cash to focus on BLA and precommercial activities

Well capitalized with cash, cash equivalents and marketable securities of $285 million

BOSTON & MONTREAL, June 15, 2026 – enGene Therapeutics Inc. (Nasdaq: ENGN, “enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company today announced its financial results for the second quarter ended April 30, 2026, and provided clinical and corporate updates.

“Feedback from the urology community on the emerging detalimogene without surfactant profile, presented at the AUA meeting in May, supports our plan to await mature durability data in the second half of 2026 and meet with the FDA about initiating a BLA submission for detalimogene before year end,” said Ron Cooper, President and Chief Executive Officer, enGene.

Mr. Cooper continued, “We are also encouraged by the interest in the detalimogene surfactant bladder rinse study from the medical community. With patients already enrolled, we are optimistic about the potential to further enhance efficacy while maintaining the ease of use and tolerability profile that has resonated with urologists.”

"To preserve shareholder capital as we await additional durability data and meetings with the FDA, we made the very difficult decision to downsize the organization to streamline operations. We are sincerely grateful to the enGeneers who have created a high-performance culture and helped advance detalimogene and our mission to provide people living with NMIBC a new treatment option,” added Mr. Cooper.

Recent Clinical Updates

LEGEND Pivotal Cohort 1: During a plenary presentation at the recent American Urological Association (AUA) meeting, interim data were shared from LEGEND’s pivotal Cohort 1 studying detalimogene without surfactant in high-risk (HR), Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS).

Efficacy overview:

• 54% (95% CI: 45%, 63%) complete response (CR) at any time (67/124)

• Low rate of progression to muscle invasive or more advanced disease (3.2%)

Safety overview:

• Low percentage of patients experienced treatment-related adverse events (TRAEs) leading to treatment interruption (2.4%) and treatment discontinuation (2.4%)

Twenty-one patients were pending disease assessments at either six-, nine-, or 12-months as of the data

Exhibit 99.1

cutoff date of April 21, 2026. enGene is awaiting 12-month CR data from Cohort 1, as well as the majority of 12-month durability data, and expects to engage with the FDA in 2H 2026 to discuss a BLA filing.

Detalimogene plus Surfactant Cohort: In tandem with its pivotal update in May, the Company announced the initiation of an additional LEGEND cohort, which incorporates a short surfactant bladder rinse using diluted polidocanol solution. Polidocanol is an FDA-approved product used for the treatment of spider and reticular veins. Surfactants have been shown to boost efficacy with other gene therapies in preclinical models and were subsequently incorporated into clinical development of those gene therapies. In murine models tested by the Company, pretreatment with polidocanol demonstrated a 10-fold increase in mean IL-12 expression and was able to boost efficacy of a subtherapeutic dose of detalimogene. Findings were validated in a large mammal model tested by the Company where a surfactant rinse increased the distribution of detalimogene nanoparticles throughout the bladder by approximately 50% and IL-12 expression by nine-fold. The first patients have been enrolled in the surfactant cohort, and the Company may enroll up to 80 patients in this global cohort. The Company believes this approach has the potential to further enhance efficacy and durability while preserving the simplicity, tolerability, and office-based administration profile that may make detalimogene a preferred option for community urology practices, where approximately 80% of NMIBC patients receive treatment.

LEGEND Cohorts 2a, 2b and 3: As part of cash conservation efforts, the Company has stopped enrollment in these additional cohorts and plans to reevaluate its strategy for them following discussion with the FDA in 2H 2026.

Recent Corporate Updates

Reduction in Force and Executive Departures: In June 2026, enGene implemented a plan to reduce its workforce by approximately 50% to streamline operations and preserve cash. The Company has retained personnel and resources required to meet its key strategic goals and milestones, including co

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enGene Reports First Quarter 2026 Financial Results and Provides Business Update

LEGEND pivotal cohort update planned for a spring 2026 medical conference

12-month complete response data from LEGEND pivotal cohort expected in 2H 2026

Biologics License Application (BLA) submission for detalimogene planned for 2H 2026

Cash and marketable securities of $312.5 million expected to provide cash runway into 2H 2028

Expanded $125 million debt facility with Hercules Capital provides additional financial flexibility to advance detalimogene development and commercialization for bladder cancer

BOSTON & MONTREAL, March 9, 2026 – enGene Holdings Inc. (Nasdaq: ENGN, “enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company, today announced its financial results for the first quarter ended January 31, 2026, and provided a business update.

“As data from LEGEND's pivotal cohort in high-risk, BCG-unresponsive NMIBC continues to mature, we look forward to providing an update at a spring medical conference,” said Ron Cooper, President and Chief Executive Officer, enGene. “On the heels of our successful November follow-on offering, we entered 2026 in a position of financial strength and ready to execute. With RMAT and CDRP designations for detalimogene, we are in active dialogue with the FDA to ensure regulatory and manufacturing readiness as we plan for a BLA submission in the second half of this year and potential launch in 2027.”

Recent Corporate Updates

Expanded debt facility: In January 2026, the Company expanded its existing loan and security agreement with Hercules Capital, Inc. (NYSE: HTGC) (“Hercules”), for up to $125 million. Access to the additional non-dilutive capital strengthens enGene’s balance sheet in preparation for its planned Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for detalimogene voraplasmid as a treatment for high-risk, Bacillus Calmette-Guérin (“BCG”)-unresponsive non-muscle invasive bladder cancer (“NMIBC”) with carcinoma in situ (“CIS”) in the second half of 2026, and the potential commercial launch of detalimogene should it receive FDA approval.

Successful completion of public offering: In November 2025, the Company successfully closed an underwritten public offering of its common shares and pre-funded warrants at an offering price of $8.50 per share and $8.4999 per pre-funded warrant. The offering totaled $140.1 million in net proceeds, following the full exercise of the underwriters’ option to purchase additional shares.

LEGEND pivotal cohort update: In November 2025, enGene reported preliminary data from LEGEND’s pivotal cohort for patients enrolled following a protocol amendment implemented in the fourth quarter of 2024. The preliminary analysis of the post-amendment patients with at least one post-baseline disease assessment included 62 patients at 3 months and 37 patients at 6 months and demonstrated:

• 63% complete response (CR) rate at any time (n=62);

• 56% CR rate at 3 months (n=62);

• 62% CR rate at 6 months (n=37), including 4 patients who successfully converted to CR post reinduction; and

• All 5 patients who completed the 9-month assessment had a CR.

The Company completed enrollment of 125 patients in total. Data from these patients demonstrated a generally favorable tolerability profile:

• 42% of patients experienced a treatment-related adverse event (TRAE);

• 1.6% of patients experienced dose interruptions due to TRAEs; and

• 0.8% of patients experienced dose discontinuations due to TRAEs.

enGene continues to believe that detalimogene’s emerging profile supports its potential first line use in patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer with CIS.

CMC Development and Readiness Pilot (CDRP) Program: In November 2025, the Company was selected as one of nine companies to participate in the FDA’s Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program. The FDA created the CDRP Program to facilitate CMC development for therapies with compressed clinical development timeframes based on the anticipated clinical benefits of earlier patient access to the therapy. Acceptance into the program further supports enGene’s confidence in detalimogene’s potential and aligns with enGene’s commitment to strong manufacturing practices as clinical development advances.

Anticipated Milestones

• Update from LEGEND pivotal cohort planned for spring 2026 medical conference.

• 12-month complete response data from LEGEND pivotal cohort expected in 2H 2026.

• Planned BLA filing for LEGEND’s pivotal cohort in the second half of 2026.

First Quarter 2026 Financial Results

As of January 31, 2026, cash, cash equivalents and marketable securities were $312.5 million. The Company expects that its cash, cash equivalents and marketable securities will fund operating expenses, debt obligations and capital expenditures

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enGene Reports Full Year 2025 Financial Results and Provides Business Update

Completed enrollment in LEGEND’s pivotal cohort with 125 patients in high-risk, BCG-unresponsive NMIBC with carcinoma in situ

Reported preliminary 6-month complete response rate (62%) in pivotal cohort patients enrolled under amended LEGEND protocol

enGene selected for FDA’s CDRP Program to support CMC readiness

Biologic License Application (BLA) submission for detalimogene planned for 2H 2026

Cash and marketable securities plus proceeds from November financing expected to provide cash runway into 2H 2028

BOSTON & MONTREAL, December 18, 2025 – enGene Holdings Inc. (Nasdaq: ENGN, “enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company, today announced its financial results for the full year ended October 31, 2025, and provided a business update.

“We are closing 2025 in a position of strength: enrollment in LEGEND's pivotal cohort is complete and the recent data update from the LEGEND pivotal cohort supports an emerging, competitive profile for the use of detalimogene as the first choice therapy in BCG-unresponsive NMIBC if approved,” said Ron Cooper, President and Chief Executive Officer. “With recent acceptance into FDA’s CDRP program and a cash position of $342.4 million, extending our runway into the second half of 2028, we are entering the new year laser-focused on scaling our organization in preparation for our planned BLA filing in the second half of 2026 and a potential approval in 2027.”

Recent Corporate Updates

LEGEND pivotal cohort update: In November, the Company reported updated preliminary data from LEGEND’s pivotal cohort for patients who were enrolled following a protocol amendment that was implemented in the fourth quarter of 2024 (“post-amendment patients”). The preliminary analysis of the post-amendment patients with at least one post-baseline disease assessment included 62 patients at 3 months and 37 patients at 6 months. Data from these patients demonstrated:

• 63% complete response (CR) rate at any time (n=62);

• 56% CR rate at 3 months (n=62);

• 62% CR rate at 6 months (n=37), including 4 patients who successfully converted to CR post reinduction; and

• All 5 patients who completed the 9-month assessment had a CR.

The Company completed enrollment of 125 patients in the pivotal cohort, exceeding its target by 25%. Data from these patients demonstrated a generally favorable tolerability profile:

• 42% of patients experienced a treatment-related adverse event (TRAE);

• 1.6% of patients experienced dose interruptions due to TRAEs; and

• 0.8% of patients experienced dose discontinuations due to TRAEs.

The Company continues to believe that detalimogene’s emerging profile supports its potential first line use in patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ (CIS).

Additional LEGEND cohort updates: In conjunction with its November data update for LEGEND’s pivotal cohort, the Company provided an enrollment update for LEGEND’s three additional cohorts:

• Cohort 2a, evaluating detalimogene in patients with high-risk NMIBC with CIS who are naïve to treatment with BCG, has enrolled 30 patients.

• Cohort 2b, evaluating detalimogene in patients with high-risk, NMIBC with CIS who have been exposed to BCG but have not received adequate BCG treatment, has enrolled 45 patients.

• Cohort 3, evaluating detalimogene in BCG-unresponsive patients with high-risk, papillary-only NMIBC, has enrolled 36 patients.

Successful completion of public offering: In November, the Company successfully closed an underwritten public offering of its common shares and pre-funded warrants at an offering price of $8.50 per share and $8.4999 per pre-funded warrant. The offering totaled $140.1 million in net proceeds, following the full exercise of the underwriters’ option to purchase additional shares.

Development and Readiness Pilot (CDRP) Program: In November, the Company was selected as one of nine companies to participate in FDA’s Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program. The FDA created the CDRP Program to facilitate CMC development for therapies with compressed clinical development timeframes based on the anticipated clinical benefits of earlier patient access to the therapy. The initiative is designed to promote earlier and more structured engagement between sponsors and the FDA on CMC development strategies, and since its inception, has led to increased collaboration with the FDA so sponsors can confidently scale up manufacturing capacity while clinical development is ongoing. Acceptance into the program further supports enGene’s confidence in detalimogene’s potential and aligns with enGene’s commitment to strong manufacturing practices as clinical development advances.

Key executive hire: In September, enGene announced the appointment of Hussein Swei