SEC Form 424B3 filed by enGene Holdings Inc.

Filed Pursuant to Rule 424(b)(3)
Registration Statement No. 333-275700

Prospectus Supplement No. 7

(to Prospectus dated March 5, 2024)

enGene Holdings Inc.

Up to 47,144,548 Common Shares and 6,386,589 Warrants to be Offered and Sold by Selling Holders

Up to 9,794,498 Common Shares Issuable Upon Exercise of Warrants

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This prospectus supplement is being filed to update and supplement the information contained in the prospectus dated March 5, 2024 (as previously supplemented, the “Prospectus”), related to the offer and sale from time to time (i) by the selling securityholders named in the prospectus (the “Selling Holders”) of certain of our common shares, without par value (“Common Shares”) and certain warrants to purchase Common Shares (“Warrants”) and (ii) by the Company of Common Shares issuable upon the exercise of Warrants with the information contained in our Current Report on Form 8-K filed with the Securities and Exchange Commission (“SEC”) on September 26, 2024, excluding the information that was furnished and not filed under Item 7.01 and the related Exhibit 99.1 and Exhibit 99.2 furnished under such report (the “Current Report”). Accordingly, we have attached the Current Report to this prospectus supplement.

This prospectus supplement updates and supplements the information in the Prospectus and is not complete without, and may not be delivered or utilized except in combination with, the Prospectus, including any amendments or supplements thereto. This prospectus supplement should be read in conjunction with the Prospectus and if there is any inconsistency between the information in the Prospectus and this prospectus supplement, you should rely on the information in this prospectus supplement.

Our Common Shares and Warrants are listed on The Nasdaq Global Select Market (“Nasdaq”), under the symbols “ENGN” and “ENGNW,” respectively. On September 24, 2024, the closing price of our Common Shares was $6.20 and the closing price for our Warrants was $2.10.

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We are an “emerging growth company” under federal securities laws and are subject to reduced public company reporting requirements. Investing in our Common Shares involves a high degree of risk. See the section entitled “Risk Factors” beginning on page 19 of the Prospectus and in any applicable prospectus supplement to read about factors you should consider before buying our securities. Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

The date of this prospectus supplement is September 26, 2024.

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

enGene Holdings Inc.

(Exact name of Registrant as Specified in Its Charter)

(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:

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

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 26, 2024, enGene Holdings Inc. (the “Company”) issued a press release announcing preliminary data from the ongoing pivotal cohort of the LEGEND study of the Company’s non-viral lead investigational product detalimogene voraplasmid, (also known as detalimogene, and previously EG-70) in patients with high-risk, Bacillus Calmette-Guérin (“BCG”)-unresponsive, non-muscle invasive bladder cancer (“NMIBC”) with carcinoma in situ (“Cis”), a copy of which is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K. In addition, on September 26, 2024, the Company announced that it intends to host a conference call to discuss the preliminary data. A form of the slide presentation to be used during that conference call is being furnished as Exhibit 99.2 to this Current Report on Form 8-K.

The information in this Item 7.01, including Exhibit 99.1 and Exhibit 99.2, 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 Events.

The LEGEND study is a multi-cohort study to establish efficacy of detalimogene in high-risk BCG-unresponsive, NMIBC patients with Cis, as well as those with papillary-only NMIBC. The ongoing pivotal cohort is an approximately 100 patient, open-label study evaluating detalimogene in BCG-unresponsive NMIBC patients with Cis. Patients receive 800µg/mL of detalimogene intravesically at weeks one, two, five, and six during a 12-week cycle, for up to four cycles, with assessments at three, six, nine, and 12 months. The study’s primary efficacy endpoint is the percentage of patients with a complete response at 12 months, based on cystoscopy, urine cytology and biopsy.

On September 26, 2024, the Company announced preliminary data from the ongoing pivotal cohort of the LEGEND study. As of the September 13, 2024 data cutoff date (the “data cutoff date”), 21 patients in the pivotal cohort had been assessed for response at three months, including 17 patients that had also been assessed for response at six months. Of the 21 patients, 15 were male and six were female, with a median age of 74 years (range 59-92). The patients had a median of 11 prior doses of BCG treatment (range 8-33) and their tumor stages were T1 plus Cis (three patients, 14.3%), Ta plus Cis (three patients, 14.3%) and Cis only (15 patients, 71.4%).

As of the data cutoff date, 71% of patients (15 of 21) achieved a complete response (“CR”) at any time, 67% of patients (14 of 21) achieved a CR at three months and 47% of patients (8 of 17) achieved a CR at six months. In the 21 patients, the complete response rate at six months was estimated using a Kaplan-Meier analysis to be 51%.

Detalimogene was generally well-tolerated by patients with no discontinuations due to treatment-related adverse events (“TRAEs”). Of the 42 patients in the safety analysis, which included all patients dosed in the LEGEND Phase 2 cohorts as of the data cutoff date, 20 patients (47.6%) experienced any grade TRAE, 17 patients (40.5%) experienced a Grade 1 TRAE, nine patients experienced a Grade 2 TRAE and two patients experienced a Grade 3 TRAE (peripheral edema and urosepsis). There were no Grade 4 or Grade 5 TRAEs reported. The most common TRAEs (≥10%) were dysuria (eight Grade 1; one Grade 2), bladder spasm (four Grade 1; four Grade 2), pollakiuria (five Grade 1; no Grade 2) and fatigue (three Grade 1; two Grade 2).

Item 9.01 Financial Statements and Exhibits.

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.