Welcome to our dedicated page for enGene Holdings 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.
Clinical-stage biotech filings can run hundreds of pages, packed with trial protocols, FDA risk factors and delicate cash-runway math. enGene Holdings’ disclosures are no exception—each document traces how its DDX non-viral platform and lead candidate EG-70 advance toward treating non-muscle invasive bladder cancer. If locating one line about dosing data or an executive option grant feels impossible, you’re not alone.
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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
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.
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