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 Therapeutics Inc., formerly enGene Holdings Inc., has changed its corporate name to enGene Therapeutics Inc., effective April 8, 2026. The amendment affects only the name; no other changes were made to the company’s articles. The company’s common shares and warrants will continue trading on Nasdaq under the symbols ENGN and ENGNW, respectively.
In a related press release, enGene explained that the new name reflects its transition toward potential commercialization of its lead gene therapy detalimogene voraplasmid. The company plans a Biologics License Application submission for detalimogene in the second half of 2026, targeting potential approval and a commercial organization in 2027.
enGene Holdings Inc. is offering up to $100,000,000 of common shares in an at‑the‑market (ATM) program to be sold from time to time through Leerink Partners LLC as sales agent.
The sales agent may sell shares on Nasdaq (symbol ENGN) using commercially reasonable efforts and will receive commissions of up to 3.0% of gross sales. The prospectus supplement cites a last reported sale price of $8.71 per share on March 5, 2026. The company reported 66,989,466 common shares outstanding as of March 5, 2026, and the prospectus shows a pro forma example of up to 78,470,522 shares outstanding assuming sale of 11,481,056 shares at $8.71. Proceeds, if any, will be used primarily to fund clinical development of detalimogene and for general corporate purposes.
enGene Holdings Inc. entered a new sales agreement with Leerink Partners that allows it to sell common shares from time to time in an at-the-market offering for an aggregate offering price of up to $100,000,000 under its existing shelf registration.
Leerink Partners will act as sales agent and receive a commission of up to 3.0% of the gross proceeds, with no obligation for enGene to sell or for Leerink to place any shares. In connection with this new arrangement, enGene terminated its prior open market sale agreement with Jefferies LLC, under which no common shares had been sold.
enGene Holdings Inc. reported a larger quarterly net loss as it continues to invest heavily in its lead bladder cancer gene therapy, detalimogene. For the three months ended January 31, 2026, net loss was $29.8M, compared with $24.6M a year earlier, driven by higher research and development and general and administrative expenses.
To support development and potential commercialization, enGene significantly strengthened its balance sheet. Cash, cash equivalents and marketable securities rose to $312.5M from $202.3M at October 31, 2025, helped by a late‑2025 equity offering and a new term loan facility of up to $125M, of which $25M is drawn. The company believes this funding will cover operating and debt needs for at least the next 12 months as it advances its pivotal LEGEND trial and prepares a planned Biologics License Application in the second half of 2026.
enGene Holdings Inc. reported a first quarter 2026 net loss attributable to common shareholders of approximately $29.8 million, or $0.44 per share, compared with about $24.6 million, or $0.48 per share, a year earlier. Operating expenses rose to $31.2 million from $26.6 million, driven by higher research and development spending on the LEGEND trial and preparation for a planned Biologics License Application, as well as increased general and administrative costs to support public company operations. Cash, cash equivalents and marketable securities were $312.5 million as of January 31, 2026, supported by a $140.1 million underwritten offering completed in November 2025 and an expanded $125 million debt facility with Hercules Capital, giving an expected cash runway into the second half of 2028. Preliminary data from the LEGEND pivotal cohort in high-risk, BCG-unresponsive non-muscle invasive bladder cancer showed complete response rates of 63% at any time (n=62), 56% at 3 months (n=62), and 62% at 6 months (n=37), with a generally favorable tolerability profile and low rates of treatment-related dose interruptions and discontinuations.
enGene Holdings Inc. is registering an aggregate of $400,000,000 of securities under a shelf registration, which includes $150,500,276.03 of unsold securities previously registered under File No. 333-283201 pursuant to Rule 415(a)(6).
The prospectus lists the securities that may be offered from time to time — common shares, preferred shares, debt securities, subscription receipts, warrants and units — and states specific terms will be provided in prospectus supplements.
enGene Holdings Inc. filed Amendment No. 1 to its annual report to add the previously omitted Part III disclosures on directors, governance, executive compensation, ownership and auditor matters, and to update certain exhibits.
The amendment does not change prior financial statements and is meant to be read together with the original annual report. It details a nine‑member, majority‑independent, staggered board, outlines the roles of key committees, and describes the company’s code of conduct and insider trading policy. It also provides 2025 compensation data for the CEO, CFO and Chief Medical Officer and summarizes the 2023 Incentive Equity Plan, including stock option practices, severance terms and change‑of‑control treatment for equity awards.
enGene Holdings Inc. (ENGN) received an updated large-holder disclosure as Venrock-affiliated funds and related individuals reported beneficial ownership of 4,771,414 Common Shares, representing 7.1% of the company as of December 31, 2025.
The ownership is spread across Venrock Healthcare Capital Partners III, L.P., VHCP Co-Investment Holdings III, LLC, Venrock Healthcare Capital Partners EG, L.P., and related management entities, with Nimish Shah and Bong Y. Koh as voting members. The percentage is based on 66,984,661 Common Shares outstanding as of December 17, 2025. The group certifies the shares were not acquired to change or influence control of enGene.
Cormorant Asset Management, LP and Bihua Chen have disclosed a significant passive stake in enGene Holdings Inc. common shares. They report beneficial ownership of 4,000,000 common shares, representing 5.97% of the class, held through certain Cormorant funds.
The percentage is calculated using 66,984,661 common shares outstanding as of December 17, 2025, as stated in enGene’s Form 10-K. All 4,000,000 shares are reported with shared voting and shared dispositive power, with no sole voting or dispositive power. The holding is certified as being in the ordinary course of business and not for the purpose of changing or influencing control of enGene.