Earnings summaries and quarterly performance for enGene Holdings.
Executive leadership at enGene Holdings.
Ronald H.W. Cooper
Detailed
Chief Executive Officer and President
CEO
DA
Dr. Alexander Nichols
Detailed
Chief Strategy and Operations Officer
DA
Dr. Anthony T. Cheung
Detailed
Chief Scientific Officer
JB
Jill Buck
Detailed
Chief Development Officer
JC
Joan Connolly
Detailed
Chief Technology Officer
LG
Lee G. Giguere
Detailed
Chief Legal Officer and Corporate Secretary
MB
Matthew Boyd
Detailed
Chief Regulatory Officer
RD
Ryan Daws
Detailed
Chief Financial Officer
Board of directors at enGene Holdings.
Research analysts covering enGene Holdings.
Recent press releases and 8-K filings for ENGN.
enGene Holdings Inc. Amends Loan Agreement and Issues Warrants
ENGN
Debt Issuance
- enGene Holdings Inc. entered into a Second Amendment to its Amended & Restated Loan and Security Agreement on January 20, 2026, with Lenders and Hercules Capital, Inc..
- In connection with this amendment, the company issued 40,850 2026 Warrants to Lenders on the Closing Date, with an exercise price of $9.18 per share, exercisable for seven years. The maximum number of 2026 Warrants that can be issued is 204,248, tied to a total commitment of $125,000,000 in 2026 Term Loans.
- The amended agreement introduces new financial covenants, including maintaining Unrestricted Cash of $10,000,000, which increases to $22,500,000 after a Minimum Cash Trigger Event. A Performance Covenant also requires Net Product Revenue to be at least 65% of the Commercial Revenue Forecast if 2026 Term Loans exceed $60,000,000, with specific waiver conditions.
Jan 21, 2026, 9:05 PM
enGene Announces Expanded Debt Facility with Hercules Capital
ENGN
Debt Issuance
New Projects/Investments
- enGene Holdings Inc. has entered into an amendment to its loan agreement with Hercules Capital, Inc. for up to US$125 million.
- This expanded debt facility provides additional financial flexibility to advance detalimogene development and commercialization for bladder cancer, including preparation for a Biologics License Application (BLA) filing in the second half of 2026 and potential commercial launch in 2027.
- $25 million was funded at the close of the amendment to refinance existing debt, with an additional $75 million available in three tranches upon achieving certain clinical, regulatory, and commercial milestones.
- A final $25 million tranche may be made upon request of the company and at the discretion of Hercules.
- The principal amount outstanding and accrued interest under the loan agreement are to be repaid on or before January 1, 2030.
Jan 21, 2026, 12:38 PM
enGene Holdings Inc. Announces Full Year 2025 Financial Results and Business Updates
ENGN
Earnings
Guidance Update
New Projects/Investments
- enGene Holdings Inc. reported a net loss attributable to common shareholders of $117.3 million, or $2.29 per share, for the full year ended October 31, 2025, with total operating expenses of $123.2 million.
- As of October 31, 2025, cash, cash equivalents, and marketable securities were $202.3 million, and with an additional $140.1 million in net proceeds from a November public offering, the company expects its cash runway to extend into the second half of 2028.
- Enrollment for the LEGEND pivotal cohort was completed with 125 patients, and preliminary data showed a 62% complete response rate at 6 months in post-amendment patients.
- The company plans a Biologic License Application (BLA) submission for detalimogene in the second half of 2026 and has been selected for the FDA's CDRP Program.
Dec 22, 2025, 9:04 PM
enGene Holdings Provides Update on Detalimogene Voraplasmid Development and Financial Runway
ENGN
Product Launch
Guidance Update
New Projects/Investments
- enGene Holdings is developing detalimogene voraplasmid, a non-viral genetic therapy for non-muscle invasive bladder cancer (NMIBC), a disease with a large market forecast.
- The company anticipates near-term catalysts including a data update in H2 2026 and a BLA filing and potential launch in 2027.
- In the registrational LEGEND study, patients treated under the updated protocol showed a six-month complete response rate of 62% and an anytime response rate of 63%.
- enGene has secured CDRP and RMAT designations from the FDA, which are anticipated to streamline manufacturing and review processes.
- A recent fundraise has extended the company's cash runway into 2028.
Dec 2, 2025, 5:10 PM
enGene Holdings provides clinical and regulatory updates for detalimogene voraplasmid
ENGN
New Projects/Investments
Guidance Update
- enGene Holdings' lead product, detalimogene voraplasmid, a non-viral genetic therapy for non-muscle invasive bladder cancer (NMIBC), demonstrated a 62% complete response rate at six months and a 63% anytime response rate in post-protocol patients from the LEGEND study.
- The company announced it was awarded CDRP designation on December 2, 2025, which is expected to streamline the manufacturing process at review time, complementing its existing RMAT designation.
- Key upcoming milestones include a data update in the second half of 2026, followed by a BLA filing and potential launch in 2027.
- A recent fundraise has extended the company's cash runway into 2028.
Dec 2, 2025, 5:10 PM
enGene Holdings Provides Update on Detalimogene Voraplasmid Clinical Development
ENGN
New Projects/Investments
Product Launch
- enGene Holdings is developing detalimogene voraplasmid, a non-viral gene therapy for non-muscle invasive bladder cancer (NMIBC), which is currently in a registrational study.
- The LEGEND study for BCG-unresponsive NMIBC patients with carcinoma in situ recently reported a six-month complete response rate of 62% and an anytime response rate of 63% in post-protocol patients, showing a meaningful improvement over pre-protocol results.
- The company has received CDRP designation for increased correspondence around CMC and RMAT designation for its product.
- Key upcoming catalysts include a data update in the second half of 2026, a BLA filing, and a potential launch in 2027.
- Following a recent fundraise, enGene's cash runway has been updated to extend into 2028.
Dec 2, 2025, 5:10 PM
enGene Provides Update on Detalimogene Voraplasmid Development and Market Opportunity
ENGN
New Projects/Investments
Guidance Update
Product Launch
- enGene is developing detalimogene voraplasmid, a non-viral gene therapy for non-muscle invasive bladder cancer (NMIBC), targeting a market projected to grow to over $20 billion.
- The product demonstrated a 62% six-month complete response rate in a pivotal program for BCG-unresponsive NMIBC patients, with favorable tolerability (mostly grade 1 or 2 AEs at 42%) and low dose interruptions (1.6%).
- enGene plans a data update and regulatory filing in the second half of next year (2026), with potential approval in 2027.
- The company recently raised over $100 million, providing a financial runway into 2027.
Nov 18, 2025, 8:30 AM
enGene Provides Update on Detalimogene Voraplasmid Development and Financial Position
ENGN
Product Launch
New Projects/Investments
Guidance Update
- enGene is developing detalimogene voraplasmid, a non-viral gene therapy for non-muscle invasive bladder cancer (NMIBC), which is currently in a pivotal program.
- The company plans a data update and regulatory filing in the second half of 2026, with potential approval in 2027.
- Recent data from the LEGEND trial showed a six-month complete response rate of 62% for patients in the new protocol cohort, demonstrating competitive efficacy and favorable tolerability with 42% grade 1 or 2 adverse events.
- enGene recently completed a fundraising round, raising over $100 million, providing capital runway into 2027.
- The NMIBC market is projected to grow to over $20 billion, and detalimogene is positioned for community urologists due to its ease of use and competitive profile.
Nov 18, 2025, 8:30 AM
enGene Announces Pricing of $130 Million Public Offering
ENGN
- enGene Holdings Inc. priced a public offering on November 12, 2025, consisting of 12,558,823 common shares at $8.50 per share and 2,735,295 pre-funded warrants at $8.4999 per pre-funded warrant.
- The aggregate gross proceeds from this offering are expected to be approximately $130 million.
- The company also granted the underwriters a 30-day option to purchase up to 2,294,117 additional common shares.
- The pre-funded warrants have an exercise price of $0.0001 per share and can be exercised at any time until fully exercised.
- The offering was expected to close on or about November 14, 2025.
Nov 14, 2025, 9:39 PM
enGene Holdings Inc. Provides Update on Detalimogene Voraplasmid Clinical Program and 2027 Approval Target
ENGN
Product Launch
New Projects/Investments
Guidance Update
- enGene Holdings Inc. is developing detalimogene voraplasmid, a non-viral gene therapy targeting non-muscle invasive bladder cancer (NMIBC), a condition affecting approximately 730,000 patients in the US.
- The pivotal cohort of the LEGEND program for BCG-unresponsive NMIBC patients with CIS has completed enrollment of 125 patients.
- Clinical data from post-amendment patients shows a 63% anytime complete response rate (in 62 patients) and a 62% six-month complete response rate, indicating competitive efficacy compared to other approved products.
- The product demonstrates a strong tolerability profile with a 42% treatment-related adverse event rate and low rates of dose interruptions (1.6%) and discontinuations (0.8%), which is notably better than other agents.
- Detalimogene voraplasmid offers logistical advantages due to its non-viral nature, simplifying storage and administration for community urologists. The company projects a potential FDA approval in 2027 and has sufficient cash to operate until then.
Nov 12, 2025, 7:00 PM
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