Welcome to our dedicated page for enGene Therapeutics SEC filings (Ticker: ENGN), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
This page compiles U.S. Securities and Exchange Commission (SEC) filings for enGene Holdings Inc. (NASDAQ: ENGN), a British Columbia–incorporated, clinical-stage biotechnology company developing non-viral genetic medicines. Through these filings, investors can review how enGene reports clinical, regulatory, financial, and governance developments related to its lead program, detalimogene voraplasmid, and its broader corporate activities.
enGene’s current reports on Form 8-K provide detail on material events such as updated preliminary efficacy and safety data from the Phase 2 LEGEND trial in high-risk non-muscle invasive bladder cancer (NMIBC), changes to trial endpoints following discussions with the U.S. Food and Drug Administration, and enrollment status across LEGEND cohorts. Other 8-K filings describe executive and board appointments, amendments to executive employment agreements, and inducement equity awards granted under NASDAQ Listing Rule 5635(c)(4).
Filings also confirm that enGene’s common shares trade on The Nasdaq Stock Market LLC under the symbol ENGN, with warrants listed under ENGNW, and identify the company as an emerging growth company. Liquidity and capital structure information, including cash, cash equivalents and marketable securities balances and details of public offerings of common shares and pre-funded warrants, appear in financial disclosures and referenced exhibits.
On Stock Titan, users can access these SEC documents alongside AI-powered summaries that explain key points in clear language. Real-time updates from EDGAR surface new 8-Ks and other filings as they are submitted, while AI highlights sections related to clinical trial results, regulatory designations such as RMAT and Fast Track, manufacturing readiness programs like the FDA’s CDRP, and board or management changes. Form 4 insider transaction data, when filed, and periodic reports such as 10-K and 10-Q can be reviewed with AI-generated insights to help readers quickly understand complex regulatory and financial information.
enGene Holdings Inc. entered into a Second Amendment to its loan and security agreement with Hercules Capital and other lenders, expanding its term loan facility from $50 million to up to $125 million, available in multiple milestone-based tranches. An initial $25 million Tranche 1 advance was funded on January 20, 2026 to refinance the prior term loans, and additional tranches of up to $35 million, $20 million, and $20 million are tied to defined clinical, approval and commercial milestones, plus an uncommitted $25 million tranche subject to lender approval.
The 2026 Term Loans mature on January 1, 2030 and bear interest at the greater of the prime rate plus 2.25% (capped at 10.25%) or 9.25%, with facility charges and a 5.95% end-of-term fee. The loans are secured by a senior lien on substantially all of the borrowers’ assets, including intellectual property. In connection with each loan advance, the lenders receive 2026 Warrants exercisable at $9.18 per share for seven years; on the Closing Date, they received 40,850 warrants, and the total potential issuance is capped at 204,248 warrants and underlying common shares if the full commitment is drawn.
enGene Holdings Inc. filed a current report describing a communication about its debt arrangements. The company announced that it entered into a Second Amendment to its Amended and Restated Loan and Security Agreement with Hercules Capital, Inc. and other lenders. This amendment builds on the original agreement dated December 22, 2023 and a prior amendment dated December 18, 2024, together referred to as the Amended Loan Agreement.
The company issued a press release on January 20, 2026 explaining the updated loan terms, which is furnished as an exhibit to the report rather than filed. As an emerging growth company with common shares and warrants listed on Nasdaq, enGene is using this report primarily to provide investors with notice of the press release and the existence of the amended loan agreement.
enGene Holdings Inc. (ENGN) launched a primary offering of 12,558,823 common shares and pre-funded warrants to purchase 2,735,295 common shares. The shares were priced at $8.50 and the pre-funded warrants at $8.4999 (with a $0.0001 exercise price). Gross proceeds are $129,999,729.47, with underwriting discounts of $7,800,000.18 and proceeds to enGene before expenses of $122,199,729.29. The underwriters have a 30-day option to buy up to 2,294,117 additional shares.
Net proceeds are estimated at approximately $121.77 million, or approximately $140.10 million if the option is fully exercised. The company plans to use the funds to advance clinical development of its lead gene therapy, detalimogene, prepare commercial infrastructure for a potential launch, and for general corporate purposes. Pre-funded warrants are immediately exercisable, do not expire, include a 9.99% beneficial ownership cap (adjustable up to 19.99% after 61 days), and will not be listed. Common shares outstanding were 52,019,362 as of November 11, 2025.
enGene Holdings Inc. (ENGN) launched a preliminary prospectus supplement for a primary offering of common shares pursuant to its shelf registration. The common shares trade on Nasdaq under “ENGN”; the last reported sale price was $8.82 per share on November 11, 2025.
The company plans to use net proceeds to fund continued clinical development of its lead gene therapy, detalimogene voraplasmid, prepare commercial infrastructure for a potential launch, and for general corporate purposes. As of October 31, 2025, cash, cash equivalents and short‑term investments were $202.4 million. The filing includes a 30‑day option for underwriters to purchase additional shares and a 90‑day lock‑up for the company, directors and officers. No sales will be made in Canada or knowingly to Canadian residents.
enGene is an emerging growth and smaller reporting company. In updated Phase 2 LEGEND data for BCG‑unresponsive NMIBC with CIS, Post‑Protocol Amendment Patients showed a complete response rate of 63% (any time; 95% CI: 51–74), 56% at 3 months (95% CI: 44–68) and 62% at 6 months (95% CI: 46–76). Shares outstanding were 52,019,362 as of November 11, 2025.
enGene Holdings Inc. reported updates from its ongoing Phase 2 LEGEND trial of detalimogene voraplasmid in high-risk, BCG‑unresponsive NMIBC. After discussions with the FDA, the pivotal cohort’s primary endpoint changed to complete response (CR) at any time, with duration of response as a key secondary endpoint. Cohort 1 completed enrollment of 125 patients.
Preliminary efficacy in the ITT subpopulations showed for Post‑Protocol Amendment Patients: CR rates of 63% (95% CI: 51–74) at any time, 56% at 3 months, and 62% at 6 months. For Pre‑Protocol Amendment Patients: 55% at any time, 55% at 3 months, and 41% at 6 months. Four Post‑Protocol patients without CR at 3 months converted to CR at 6 months.
Safety was favorable: among 125 patients, 42% experienced treatment‑related adverse events, mainly Grade 1/2; Grade 3 TRAEs occurred in 2.4%, with no Grade 4/5 reported. As of October 31, 2025, cash, cash equivalents and short‑term investments were $202.4 million.
enGene Holdings Inc. updated the employment agreement of executive Ronald H. W. Cooper. The Board of Directors, following a recommendation from its Compensation Committee, approved an amendment that increases his potential cash payout if his employment ends in connection with a change in control of the company.
Under the revised terms, if Mr. Cooper experiences a CIC Termination as defined in his agreement and complies with its conditions, he will receive a lump sum payment equal to 1.5x his annual target bonus, instead of the prior 1.0x multiple. This payment would be made within 45 days of the qualifying termination. The full amendment will be included as an exhibit to enGene’s Form 10-K for the fiscal year ending October 31, 2025.
enGene Holdings Inc. updated a prior report to clarify board committee assignments for two recently appointed directors. Effective October 2, 2025, the board named Philip Astley-Sparke to the Audit Committee and the Nominating and Corporate Governance Committee. Michael Heffernan was appointed to the Audit Committee and the Compensation Committee.
enGene Holdings Inc. Chief Medical Officer Hussein Sweiti was granted a non-qualified stock option to purchase 600,000 common shares at an exercise price of $6.83 per share, with an expiration date of 09/30/2035. The grant was awarded on 09/30/2025 as an inducement award outside the company019s 2023 Incentive Equity Plan in accordance with NASDAQ Listing Rule 5635(c)(4). The option vests 25% on 09/29/2026 (the first anniversary of employment) and the remainder vests monthly over the next three years, subject to continued service. The Form 4 was signed by an attorney-in-fact on behalf of the reporting person and filed on 10/01/2025.
enGene Holdings Inc. filed a current report noting that it issued a press release on September 30, 2025 announcing the appointment of Dr. Hussein Sweiti as Chief Medical Officer. The press release is furnished, not filed, as Exhibit 99.1 and is not automatically incorporated into other securities filings.