enGene Holdings (NASDAQ: ENGNW) completes Cohort 1 LEGEND enrollment

Rhea-AI Filing Summary

enGene Holdings Inc. reported a clinical milestone and updated its investor materials. The company reached its target enrollment of 100 patients in Cohort 1, the pivotal cohort of the Phase 2 portion of the LEGEND trial evaluating detalimogene voraplasmid in high-risk, non-muscle invasive bladder cancer that is unresponsive to Bacillus Calmette-Guérin. Cohort 1 focuses on patients with carcinoma in-situ, with or without concomitant papillary disease. enGene also refreshed its Corporate Presentation and furnished it as an exhibit, while a press release describing the enrollment milestone was filed as a separate exhibit.

Insights

Biotech and clinical trial analyst

enGene fully enrolled a pivotal Phase 2 LEGEND cohort for detalimogene.

enGene Holdings Inc. disclosed that it has achieved target enrollment of 100 patients in Cohort 1, the pivotal cohort of the Phase 2 portion of the LEGEND trial for detalimogene voraplasmid. This cohort focuses on high-risk, non-muscle invasive bladder cancer with carcinoma in-situ, including cases with or without concomitant papillary disease, in patients who are unresponsive to Bacillus Calmette-Guérin.

Reaching full enrollment is an important operational step because it allows the study to progress toward data readout without further recruitment delays. The patient population is clinically challenging, as BCG-unresponsive disease has limited treatment options, so any future efficacy and safety results from this group could be meaningful for understanding detalimogene’s potential.

The company also updated its Corporate Presentation and filed both the deck and the press release as exhibits dated September 3, 2025. Subsequent company communications and future filings are likely to provide more detail on trial timelines and emerging LEGEND results once they are available.

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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): September 03, 2025

enGene Holdings Inc.

(Exact name of Registrant as Specified in Its Charter)

British Columbia			001-41854	Not applicable
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
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

(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 7.01 Regulation FD Disclosure.

On September 3, 2025, enGene Holdings Inc. (the “Company”) updated its Corporate Presentation, a copy of which is furnished with this Form 8-K as Exhibit 99.1 and incorporated into this Item 7.01 by reference. The information in this Item 7.01 of Form 8-K (including Exhibit 99.1) shall not be deemed to be “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of such section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of the general incorporation language of such filing, except as shall be expressly set forth by specific reference in such filing.

Item 8.01 Other Events.

On September 3, 2025, the Company issued a news release announcing that it achieved its target enrollment of 100 patients in its pivotal cohort (“Cohort 1”) of the Phase 2 portion of the LEGEND trial of detalimogene voraplasmid (“detalimogene”). Cohort 1 is studying detalimogene in patients with high-risk, non-muscle invasive bladder cancer with carcinoma in-situ with or without concomitant papillary disease who are unresponsive to Bacillus Calmette-Guérin. A copy of the news release is filed with this Form 8-K as Exhibit 99.2 and incorporated into this Item 8.01 by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description of Exhibits
99.1		Corporate Presentation, dated September 3, 2025.
99.2		Press Release of the Company, dated September 3, 2025.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

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:	September 3, 2025	By:	/s/ Ronald H.W.Cooper
			Name: Ronald H.W.Cooper Title: Chief Executive Officer and President

FAQ

What did enGene Holdings (ENGNW) disclose in this 8-K filing?

enGene Holdings Inc. reported that it reached target enrollment of 100 patients in Cohort 1 of the Phase 2 portion of the LEGEND trial for detalimogene voraplasmid and also updated its Corporate Presentation, both of which were provided as exhibits.

What is Cohort 1 in enGene Holdings (ENGNW) LEGEND trial?

Cohort 1 is described as the pivotal cohort of the Phase 2 portion of the LEGEND trial, studying detalimogene voraplasmid in patients with high-risk, non-muscle invasive bladder cancer with carcinoma in-situ, with or without concomitant papillary disease, who are unresponsive to Bacillus Calmette-Guérin.

How many patients has enGene enrolled in the LEGEND Phase 2 Cohort 1?

The company announced that it achieved its target enrollment of 100 patients in Cohort 1 of the Phase 2 portion of the LEGEND trial.

What exhibits did enGene Holdings (ENGNW) include with this 8-K?

The filing includes a Corporate Presentation dated September 3, 2025 as Exhibit 99.1, a press release dated the same day announcing the enrollment milestone as Exhibit 99.2, and the Cover Page Interactive Data File as Exhibit 104.

How is the updated Corporate Presentation treated under securities laws?

The updated Corporate Presentation furnished as Exhibit 99.1 is stated as not being deemed “filed” for purposes of Section 18 of the Exchange Act and is not automatically incorporated by reference into other Securities Act or Exchange Act filings unless specifically referenced.

What type of bladder cancer is enGene targeting in the LEGEND trial?

The LEGEND trial’s Cohort 1 targets patients with high-risk, non-muscle invasive bladder cancer characterized by carcinoma in-situ, with or without concomitant papillary disease, who are unresponsive to Bacillus Calmette-Guérin.