UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 11 12, 2025

enGene Holdings Inc.

(Exact name of Registrant as Specified in Its Charter)

British Columbia	001-41854	Not applicable
(State or Other Jurisdictionof Incorporation)	(CommissionFile Number)	(IRS EmployerIdentification No.)
4868 Rue Levy, Suite 220
Saint-Laurent, Quebec, Canada		H4R 2P1
(Address of Principal Executive Offices)		(Zip Code)


4868 Rue Levy, Suite 220
Saint-Laurent, Quebec, Canada		H4R 2P1
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s Telephone Number, Including Area Code: 514 332-4888

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Shares	ENGN	The Nasdaq Stock Market LLC
Warrants, each exercisable for one Common Share, at an exercise price of $11.50 per Share	ENGNW	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒

Item 1.01

Entry into a Material Definitive Agreement.

On November 12, 2025, enGene Holdings Inc. (the “Company”) entered into an underwriting agreement (the “Underwriting Agreement”) with Jefferies LLC, Leerink Partners LLC and Wells Fargo Securities, LLC, as representatives of the several underwriters named therein (collectively, the “Underwriters”), relating to the issuance and sale by the Company, in an underwritten public offering (the “Offering”) of 12,558,823 common shares of the Company, no par value per share (“Common Shares”), at a public offering price of $8.50 per Common Share, and pre-funded warrants to purchase 2,735,295 Common Shares (the “Pre-Funded Warrants”) at an offering price of $8.4999 per Pre-Funded Warrant, in each case before underwriting discounts and commissions. The aggregate gross proceeds to the Company from the Offering, before deducting the underwriting discounts and commissions and offering expenses payable by the Company, are approximately $130 million. All securities sold in the Offering were offered by the Company. The Offering closed on November 14, 2025. In addition, the Company also granted to the Underwriters a 30-day option to purchase up to 2,294,117 additional Common Shares at the public offering price, less underwriting discounts and commissions (the “Option”).

The Offering was made pursuant to the Company’s registration statement on Form S-3 (File No. 333-283201), which was filed with the U.S. Securities and Exchange Commission (the “SEC”) on November 13, 2024 and declared effective on November 21, 2024, as supplemented by a prospectus supplement filed with the SEC pursuant to Rule 424(b) under the Securities Act of 1933, as amended (the “Securities Act”).

Each Pre-Funded Warrant has an initial exercise price per share of $0.0001, subject to certain adjustments. The Pre-Funded Warrants may be exercised at any time until exercised in full. A holder (together with its affiliates and other attribution parties) may not exercise any portion of a Pre-Funded Warrant to the extent that immediately prior to or after giving effect to such exercise the holder would own more than 9.99% of the Company’s outstanding Common Shares immediately after exercise, which percentage may be changed at the holder’s election to a lower or higher percentage not in excess of 19.99% (if exceeding such percentage would result in a change of control under Nasdaq Listing Rule 5635(b) or any successor rule) upon 61 days’ notice to the Company, subject to the terms of the Pre-Funded Warrants.

The Underwriting Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities under the Securities Act, other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by such parties.

The foregoing descriptions of the terms of the Underwriting Agreement and Pre-Funded Warrants do not purport to be complete and are qualified in their entirety by reference to the Underwriting Agreement and form of Pre-Funded Warrant, which are filed as Exhibit 1.1 and Exhibit 4.1 hereto, respectively, and incorporated herein by reference. Copies of the opinion of Blake, Cassels & Graydon LLP, with respect to matters of Canadian law, and Morgan, Lewis & Bockius LLP, with respect to matters of U.S. law, are filed hereto as Exhibits 5.1 and 5.2, respectively.

Item 7.01

Regulation FD Disclosure.

On November 1112, 2025, ~~enGene Holdings, Inc. (~~the “Company”) issued a press release ~~announcing~~entitled ~~updates~~“enGene ~~regarding~~Announces ~~the~~Pricing ~~pivotal cohort~~ of ~~its~~$130 ~~ongoing~~Million ~~Phase~~Public 2Offering ~~LEGEND trial~~ of ~~detalimogene~~Common ~~voraplasmid~~Shares ~~(also known as “detalimogene”~~ and ~~previously EG~~Pre-~~70)~~Funded ~~in high-risk, Bacillus Calmette-Guérin (“BCG~~Warrants.”~~)-unresponsive~~ ~~patients~~The ~~with~~full ~~carcinoma~~text in situ (“CIS”) with or without concomitant papillary disease, including new preliminary clinical data. In addition, as announced in a press release issued November 10, 2025, the Company hosted a conference call on November 11, 2025 to discuss the preliminary clinical data and made available a slide presentation for the conference call, as well as an updated Corporate Presentation to be used during future investor meetings. A copy of the press ~~releases~~release ~~issued~~is ~~November 10th and 11th, the slide presentation for the conference call and the Corporate Presentation are being~~ furnished as ~~Exhibits~~Exhibit 99.1, ~~99.2, 99.3 and 99.4, respectively,~~ to this Current Report on Form 8-K and is incorporated herein by reference.

The information in this Item 7.01, including ~~Exhibits~~ Exhibit 99.1, ~~99.2, 99.3 and 99.4,~~ shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act ~~of 1933, as amended,~~ or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 8.01 Other Information.

Detalimogene is being evaluated in the ongoing, open-label, multi-cohort, Phase 2 LEGEND trial to establish its safety and efficacy in high-risk NMIBC. LEGEND’s pivotal cohort (“Cohort 1”) has completed enrollment of 125 patients with high-risk, BCG-unresponsive NMIBC with CIS with or without papillary disease. In addition to Cohort 1, LEGEND includes three additional cohorts, which include NMIBC patients with CIS who are naïve to treatment with BCG (“Cohort 2a”); NMIBC patients with CIS who have been exposed to BCG but have not received adequate BCG treatment (“Cohort 2b”); and BCG-unresponsive high-risk NMIBC patients with papillary-only disease (“Cohort 3”).

Following recent discussions with the U.S. Food and Drug Administration (the “FDA”) the primary endpoint for Cohort 1 will change to complete response (“CR”) at any time from its previous primary endpoint of landmark 12-month CR rate, with its key secondary endpoint becoming duration of response rate. This updated primary endpoint is consistent with other recent programs for BCG-unresponsive NMIBC registered with FDA.

Preliminary Efficacy Data

On November 11, 2025, the Company announced updated preliminary efficacy data from two patient subpopulations of the intent-to-treat (“ITT”) patient population of Cohort 1 consisting of (i) patients who received at least one dose of detalimogene and had at least one post-baseline disease assessment and were enrolled prior to the amendment of the protocol in the fourth quarter of 2024 (the “Pre-Protocol Amendment Patients”) and (ii) patients who received at least one dose of detalimogene and had at least one post-baseline disease assessment and were enrolled following the amendment of the protocol in the fourth quarter of 2024 (the “Post-Protocol Amendment Patients”). As of October 24, 2025, the ITT population consisted of 31 Pre-Protocol Amendment Patients and 62 Post-Protocol Amendment Patients. The table below summarizes preliminary efficacy results from the two separate patient subpopulations:

ITT Population*		Any Time(N=62)	3 Month (N=62)	6 Month**(N=37)
Post-Protocol Amendment Patients	CR Rate	63% (CI: 51-74)	56% (CI: 44-68)	62% (CI: 46-76)
		Any Time (N=31)	3 Month (N=31)	6 Month (N=27)
Pre-Protocol Amendment Patients	CR Rate	55% (CI: 38-71)	55% (CI: 38-71)	41% (CI: 25-59)

Data as of October 24, 2025.

* ITT: Intent-To-Treat population includes all Pre-Protocol Amendment Patients and Post-Protocol Amendment Patients, respectively, who received at least 1 dose of treatment and had at least 1 post-baseline disease assessment.

** CR rates at 6 months include only patients who were evaluable at the 6-month timepoint or had disease progression prior to the 6-month assessment.

CI: 95% Confidence Interval

The preliminary efficacy data for Pre-Protocol Amendment Patients demonstrated a markedly lower 12-month CR rate than those of FDA-approved products for BCG-unresponsive NMIBC patients.

Among the Post-Protocol Amendment Patients, four patients that did not have a CR at the 3-month assessment converted to a CR at the 6-month assessment. In addition, of the 23 patients in this subpopulation with a CR at the 6-month assessment, five patients remained in CR at the 9-month assessment, 17 patients are pending their 9-month assessment and one patient dropped out of the study prior to the 9-month assessment.

Preliminary Safety Data

Detalimogene’s overall tolerability profile was favorable. Of the 125 patients assessed for safety in Cohort 1, as of October 24, 2025, 53 patients (42%) experienced at least one treatment-related adverse event (“TRAE”), which were mainly Grade 1/2 in severity, except for three patients (2.4%) that experienced Grade 3 TRAEs. The most common TRAEs were Bladder Spasm (10.4%), Dysuria (12.0%), Fatigue (16.8%), Micturition urgency (10.4%), and Pollakiuria (10.4%). There were no Grade 4 or Grade 5 TRAEs reported. Among the three patients with Grade 3 TRAEs, there were no drug discontinuations related to the severe adverse events. The rate of TRAEs leading to dose interruptions was 1.6% and to dose discontinuations was 0.8%.

Additional LEGEND Trial Updates

On November 11, 2025, the Company also announced updates regarding enrollment in the other cohorts of the LEGEND trial:

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

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

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

Cash and Liquidity Update

As of October 31, 2025, the Company had cash, cash equivalents and short-term investments of $202.4 million.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

ExhibitNumber		Description
99.1		Press Release of the Company, dated November 10, 2025
1.1		Underwriting Agreement, dated November 12, 2025, by and among enGene Holdings Inc., Jefferies LLC, Leerink Partners LLC and Wells Fargo Securities, LLC
99.2		Press Release of the Company, dated November 11, 2025
4.1		Form of Pre-Funded Warrant
99.3		Slide Presentation, dated November 11, 2025
5.1		Opinion of Blake, Cassels & Graydon LLP
99.4		Corporate Presentation, dated November 11, 2025
5.2		Opinion of Morgan, Lewis & Bockius LLP
23.1		Consent of Blake, Cassels & Graydon LLP (included in Exhibit 5.1)
23.2		Consent of Morgan, Lewis & Bockius LLP (included in Exhibit 5.2)
99.1		Press Release of enGene Holdings Inc. dated November 12, 2025.
104		Cover Page Interactive Data File (Formatted as Inline XBRL)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

		ENGENE HOLDINGS INC.
Date: November 12, 2025	By:	/s/ Ronald H.W. Cooper
Date: November 14, 2025	By:	/s/ Ronald H.W. Cooper
	Name:	Ronald H.W. Cooper
	Title:	Chief Executive Officer and President

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