8-K

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): June 14, 2024

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 Common 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 2.02 Results of Operations and Financial Condition.

On June 14, 2024, enGene Holdings Inc. (the "Company") announced its financial results for the second financial quarter ended April 30, 2024. A copy of the press release issued in connection with the announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

Item 7.01. Regulation FD Disclosure.

On June 14, 2024, the Company updated its Corporate Presentation. The updated Corporate Presentation is being furnished as Exhibit 99.2 to this Current Report on Form 8-K and incorporated herein by reference.

The information in this Current Report on Form 8-K (including Exhibits 99.1 and 99.2 attached hereto) is intended to be furnished and 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 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description of Exhibits
99.1	Press Release, dated June 14, 2024
99.2	Corporate Presentation, dated June 14, 2024
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:	June 14, 2024	By:	/s/ Jason D. Hanson
			Name: Jason D. Hanson Title: Chief Executive Officer

EX-99.1

 

enGene Reports Second Quarter 2024 Financial Results and Provides a Business Update

Company announces plans for initial indication expansion for EG-70 into high-risk papillary only NMIBC

BOSTON and MONTREAL, June 14, 2024 – enGene Holdings Inc. (Nasdaq: ENGN, “enGene” or the “Company”), a clinical-stage genetic medicines company whose non-viral, intravesical lead product candidate, EG-70, is in a pivotal study for BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC), today announced its financial results for the second quarter ended April 30, 2024, and provided a business update.

“Our $200 million private placement in February positioned us well to execute our primary strategy of broadly developing EG-70 to be a patient- and practice-friendly option across a multitude of potential bladder cancer indications. Correspondingly, our planned initial expansion of the LEGEND study will include a cohort focused on enrollment of patients with high-risk, BCG-unresponsive papillary-only NMIBC, a disease with persistent unmet need for which EG-70 may be well-suited,” said Jason Hanson, Chief Executive Officer of enGene. “Furthermore, we plan to provide the interim data for the LEGEND BCG-unresponsive cohort by the end of September 2024. We believe the design of EG-70, with its ease-of-use and non-viral profile, positions it well to seamlessly slot into the standard of care, with the goal of becoming a practice-changing product that does not require a change in practice for urologists.”

Anticipated Milestones and Strategic Corporate Updates

Release of interim data from LEGEND Cohort 1: The Company expects to release interim data from the LEGEND study’s BCG-unresponsive cohort by the end of September, comprised of responses from approximately 20 patients focused on the three- and six-month time points. Study enrollment remains ongoing, and based on current projections, enGene expects to file a Biologics License Application (BLA) for EG-70 in mid-2026.

Commitment to expanding the clinical development of EG-70 within the bladder: Building on the design of EG-70 to have category-leading ease of use, scalable manufacturing process, and low cost-of-goods, the Company plans to explore additional applications of EG-70 within the bladder by expanding the LEGEND study to include a third cohort targeting high-risk BCG-unresponsive papillary-only NMIBC patients and modifying the second cohort (previously, the BCG-naïve cohort) to include BCG-exposed patients. Collectively, these potential indications represent an expansion into several areas of persistent unmet medical need with substantial patient populations. These clinical development plans include:

•Papillary-only LEGEND expansion: The Company plans to expand LEGEND to enroll a third cohort of patients with BCG-unresponsive, papillary-only Ta/T1 disease. This cohort, whose target enrollment is 70-100 patients, is estimated to begin enrollment in the fourth quarter of 2024.

•Modification of the second cohort of LEGEND study to separately analyze responses between BCG-naïve patients and BCG-exposed patients: In anticipation of this planned cohort modification and expected corresponding engagement with FDA, enrollment has been temporarily paused in this second cohort, with enrollment in both groups expected to resume in the fourth quarter of 2024.

As a result of the prioritization of these potential new indications in bladder cancer, the Company has deprioritized pre-clinical development of EG-i08 for cystic fibrosis and has paused further activities on that program.

Key leadership hires and board additions: In May 2024, enGene announced the election of Paul Hastings and Wouter Joustra as new members of its Board of Directors at the Company’s 2024 annual meeting of shareholders. Lota Zoth was also re-elected to the Board. Each will serve a three-year term expiring at the 2027 annual meeting of shareholders. enGene’s Board is comprised of seven members including Richard Glickman (Chairman), Gerald Brunk, Jasper Bos, and enGene CEO, Jason Hanson.

In April 2024, the Company announced that Raj Pruthi MD MHA FACS joined the Company as SVP, Urologic Oncology and Clinical Development. Dr. Pruthi joined enGene from Johnson & Johnson Innovative Medicine, where he was most recently the Global Medical Affairs Leader, Bladder Cancer and Senior Medical Director, Oncology (Global – Prostate and Bladder Cancer).

Second Quarter 2024 Financial Results

Cash and cash equivalents, as of April 30, 2024, were $264.8 million. The Company expects that its existing cash and cash equivalents will fund operating expenses, debt obligations and capital expenditures into 2027.

Three Months ended April 30, 2024

Total operating expenses were $17.3 million for the three months ended April 30, 2024, compared to $4.7 million for the three months ended April 30, 2023. Research and development expenses increased by $6.6 million, mainly due to increasing manufacturing and clinical costs related to our pivotal EG-70 study. General and administrative expenses increased by $5.9 million, primarily driven by headcount costs and professional fees such as legal, accounting and audit as the Company scales its general and administrative function to support the operation of a public company.

For the three months ended April 30, 2024, net loss attributable to common shareholders was approximately $15.0 million, or $0.38 per share, compared to approximately $6.5 million, or $9.30 per share, for the same period for the three months ended April 30, 2023. The increase in net loss is mainly attributed to the increase in operating expenses partially offset by net interest income earned during the period.

About enGene

enGene is a clinical-stage biotechnology company mainstreaming genetic medicines through the delivery of therapeutics to mucosal tissues and other organs, with the goal of creating new ways to address diseases with high clinical needs. enGene’s lead program is EG-70 for patients with non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG) – a disease with a high clinical burden. EG-70 is being evaluated in an ongoing Phase 2 pivotal study. EG-70 was developed using enGene’s proprietary Dually Derivatized Oligochitosan (DDX) platform, which enables penetration of mucosal tissues and delivery of a wide range of sizes and types of cargo, including DNA and various forms of RNA. enGene became a publicly traded company effective November 1, 2023, upon the completion of a business combination with Forbion European Acquisition Corporation, a special purpose acquisition company. For more information, visit enGene.com.

Forward-Looking Statements

Certain statements contained in this press release may constitute “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, and “forward-looking information” within the meaning of Canadian securities laws (collectively, “forward-looking statements”). enGene’s forward-looking statements include, but are not limited to, statements regarding enGene’s management teams’ expectations, hopes, beliefs, intentions, goals or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate”, “appear”, “approximate”, “believe”, “continue”, “could”, “estimate”, “expect”, “foresee”, “intend”, “may”, “might”, “plan”, “possible”, “potential”, “predict”, “project”, “seek”, “should”, “would”, and similar expressions (or the negative version of such words or expressions) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements may include, for example, statements about: the timing and anticipated results of our current and future clinical trials, including interim results, plans regarding the composition of any interim clinical trial data presentations, beliefs as to the potential benefits of EG-70, expectations regarding the potential submission of a BLA for EG-70, plans regarding expansion and modification of LEGEND for potential additional bladder cancer indications for EG-70 and expectations regarding enrollment of patients, and the expected period over which enGene estimates its cash and cash equivalents will be sufficient to fund its current operating plan.

Many factors, risks, uncertainties and assumptions could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the Company’s ability to recruit and retain qualified scientific and management personnel; establish clinical trial sites and enroll patients in its clinical trials; execute on the Company’s clinical development plans and ability to secure regulatory approval on anticipated timelines; and other risks and uncertainties detailed in filings with Canadian securities regulators on SEDAR+ and with the U.S. Securities and Exchange Commission (“SEC”) on EDGAR, including those described in the “Risk Factors” sections of the Company’s Annual Report on Form 10-K for the fiscal year ended October 31, 2023, our Quarterly Report on Form 10-Q for the fiscal quarter ended January 31, 2024 and our Quarterly Report on Form 10-Q for the fiscal quarter ended April 30, 2024 (copies of which may be obtained at www.sedarplus.ca or www.sec.gov).

You should not place undue reliance on any forward-looking statements, which speak only as of the date on which they are made. enGene anticipates that subsequent events and developments will cause enGene’s assessments to change. While enGene may elect to update these forward-looking statements at some point in the future, enGene specifically disclaims any obligation to do so, unless required by applicable law. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved.

enGene Holdings Inc.

Condensed Consolidated Statements of Operations Information

(unaudited)

(Amounts in thousands of USD, except share and per share data)

	Three months ended April 30,					Six months ended April 30,
	2024			2023		2024			2023
Operating expenses:
Research and development	$	9,855		$	3,215	$	15,493		$	6,886
General and administrative		7,455			1,522		12,590			2,484
Total operating expenses		17,310			4,737		28,083			9,370
Loss from operations		17,310			4,737		28,083			9,370
Total other (income) expense, net		(2,347	)		545		(2,379	)		3,330
Net loss before provision for income tax		14,963			5,282		25,704			12,700
Provision for (benefit from) income taxes		21			—		(9	)		—
Net loss	$	14,984		$	5,282	$	25,695		$	12,700
Deemed dividend attributable to redeemable convertible preferred shareholders		—			1,175		—			2,389
Net loss attributable to common shareholders, basic and diluted		14,984			6,457		25,695			15,089
Weighted-average common shares outstanding, basic and diluted		39,443,768			694,497		31,186,238			680,003
Net loss per share of common shares, basic and diluted	$	0.38		$	9.30	$	0.82		$	22.19

enGene Holdings Inc.

Condensed Consolidated Balance Sheet Information

(unaudited)

(Amounts in thousands of USD)

	April 30, 2024		October 31, 2023
Cash and cash equivalents	$	264,810	$	81,521
Total assets		273,528		86,959
Total liabilities		30,562		14,473
Total shareholders’ equity (deficit)		242,966		72,486

Contact

For media contact: media@engene.com
For investor contact: investors@engene.com

EX-99.2

Corporate Presentation June 2024

Cautionary Statement Regarding Forward-Looking Statements This Presentation contains certain forward-looking statements within the meaning of the federal securities laws and "forward-looking information" within the meaning of Canadian securities laws (collectively, "forward-looking statements").  Forward-looking statements may be identified by the use of the words such as “plan”, “forecast”, “intend”, “development”, “expect”, “anticipate”, “become”, “believe”, “continue”, “could”, “estimate”, “expect”, “intends”, “may”, “might”, “plan”, “possible”, “project”, “should”, “would”, “strategy”, “future”, “potential”, “opportunity”, “target”, “term”, “will”, “would”, “will be” or similar expressions that predict or indicate future events or trends or that are not statements of historical matters.  These forward-looking statements include, but are not limited to, statements regarding estimates and forecasts of financial and performance metrics, projections of market opportunity and market share, expectations and timing related to regulatory submissions and commercial product launches.  These forward-looking statements are based on various estimates and assumptions, whether or not identified in this presentation, and on the current expectations of the management of enGene Holdings Inc. ("enGene"), are not predictions of annual performance, and are subject to risks and uncertainties.  These forward-looking statements are subject to a number of risks and uncertainties, including but not limited to, those described in the “Risk Factors” section of the Annual Report on Form 10-K filed with the United States Securities and Exchange Commission (the “SEC”) on January 29, 2024 by enGene.  You should carefully consider the risks and uncertainties described in the “Risk Factors” section of such Annual Report on Form 10-K, as well as other documents if and when filed by enGene from time to time with the SEC and Canadian securities regulators.  If any of these risks materialize or our assumptions prove incorrect, actual events and results could differ materially from those contained in the forward-looking statements.  There may be additional risks that enGene presently knows or that enGene currently believes are immaterial that could also cause actual events and results to differ.  In addition, forward-looking statements reflect enGene’s expectations, plans, or forecasts of future events and views as of the date of this presentation.  enGene anticipates that subsequent events and developments will cause enGene’s assessments to change.  While enGene may elect to update these forward-looking statements at some point in the future, enGene specifically disclaim any obligation to do so, unless required by applicable law.  These forward-looking statements should not be relied upon as representing enGene’s assessments as of any date subsequent to the date of this presentation.  Accordingly, undue reliance should not be placed upon the forward-looking statements contained herein Intellectual Property This Presentation contains trademarks, service marks, trade names, copyrights, and products of enGene and other companies, which are the property of their respective owners.  The use or display of third parties’ trademarks, service marks, trade names, copyrights, or products in this Presentation is not intended to, and does not, imply a relationship with enGene, or an endorsement of or sponsorship by enGene.  Solely for convenience, the trademarks, service marks, and trade names referred to in this Presentation may appear without the ®, TM or SM symbols, but such references are not intended to indicate, in any way, that enGene will not assert, to the fullest extent permitted under applicable law, their rights or the right of the applicable licensor in such trademarks, service marks and trade names. Industry and Market Data This Presentation relies on and refers to certain information and statistics based on estimates by enGene’s management and/or obtained from third party sources which enGene believes to be reliable.  enGene has not independently verified the accuracy or completeness of any such third party information, which involves elements of subjective judgment and analysis that may or may not prove to be accurate.  None enGene, or its affiliates or any third parties that provide information to enGene or its affiliates, such as market research firms, guarantees the accuracy, completeness, timeliness, or availability of any information.  None enGene, or its affiliates, or any third parties that provide information to enGene, and its affiliates, such as market research firms, is responsible for any errors or omissions (negligent or otherwise), regardless of the cause, or the results obtained from the use of such content.  enGene may have supplemented such information where necessary, taking into account publicly available information about other industry participants and enGene management’s best view as to information that is not publicly available.  Neither enGene nor its affiliates give any express or implied warranties with respect to the information included herein, including, but not limited to, any warranties regarding its accuracy or of merchantability or fitness for a particular purpose or use, and they expressly disclaim any responsibility or liability for direct, indirect, incidental, exemplary, compensatory, punitive, special, or consequential damages, costs, expenses, legal fees, or losses (including lost income or profits and opportunity costs) in connection with the use of the information herein. Lead Program (EG-70/detalimogene voraplasmid) The lead program described herein is an investigational drug therapy that has not been subject to testing designed to demonstrate that the therapy is effective in humans or to provide a basis to predict in advance whether an adequate level of efficacy in humans will be demonstrated in further testing.  Although deemed sufficient to permit further testing, the limited, early Phase 1 testing to date is not a sufficient basis on which to predict efficacy.  Although the FDA has indicated that the authorized Phase 2 portion of the current LEGEND study may potentially support BLA approval, that outcome will depend entirely on the results of Phase 2 tests, none of which are expected to be available until at least 2025. Disclaimers

enGene: moving genetic medicines into the mainstream

Highly differentiated program designed for community urologists: Single-step administration, more patient-friendly, no onerous viral containment / handling requirements Profile supportive of expansive applications across bladder cancer: Product candidate attributes conducive to broad physician adoption Non-viral platform supports low COGS and scalable manufacturing: Polymeric nanoparticle with non-integrating DNA cargo; already scaled for US launch Multiple anticipated value inflection points: Phase 2 interim efficacy data expected by end of September 2024 and mid-2026 BLA NMIBC = Non-muscle invasive bladder cancer; BCG = Bacillus Calmette-Guerin; BLA = Biologics License Application; COGS = Cost of Goods Sold Expected timelines and anticipated milestones reflect enGene management's current estimate and are subject to change.  Registrational-stage EG-70 program represents estimated multi-billion dollar opportunity, with initial entry in BCG-unresponsive NMIBC

Investigational genetic medicine designed for urologists: EG-70 combines promising efficacy with a unique, fit-for-purpose product profile * CR = Complete Response. 73% complete response rate represents the overall CR rate at any time during the Ph1 LEGEND study in BCG-unresponsive NMIBC with Cis. MTD = Maximum tolerated dose. Lyophilized drug product: Designed for easy reconstitution in water on an open benchtop Administered analogously to BCG: No pre-wash/vial thaw steps No special handling required (e.g., no ultra-cold chain, no BSL2/USP<800> facilities needed) EG-70 designed for ease of use in any urology clinic 73% CR rate at any time*: All Ph1 endpoints met; currently enrolling in pivotal Ph2 study Encouraging durability signals observed in Phase 1 Favorable safety profile observed to date, no MTD reached LEGEND study supports planned Mid-2026 BLA Non-viral mechanism with no observed immunogenicity supportive of repeat dosing Drug product manufacturable using scalable techniques Low COGS supports commercial opportunity across a variety of markets Non-viral DDX platform supports favourable COGS Designed to be the first script urologists write after BCG failure

EG-70 highlights favorable attributes of DDX platform, potentially enabling treatment of other mucosal organs via direct instillation Dually Derivatized Oligochitosan (DDX) Functionalized oligomeric chitosan with embedded DNA plasmid Easily reconstituted in water on open benchtops Proprietary to enGene with strong IP portfolio Non-viral plasmid-based therapies  Large capacity (>15kb) Complex cargos (EG-70 – multiple genes) Respiratory Tract Cystic Fibrosis Asthma COPD Lung cancer Nasopharynx Carcinoma Rhinitis Mucosal vaccines Gastrointestinal Tract Colorectal cancer Inflammatory Bowel Disease Short Bowel Syndrome Familial Adenomatous Polyposis Bladder (lead tissue of focus)

EG-70 (detalimogene voraplasmid)  Intravesical Phase 2 interim efficacy (Q3 2024) BLA (Mid 2026) Enrollment to commence Q4 2024 HR BCG-unresponsive NMIBC w/ carcinoma in situ (Cis) Multiple billion-dollar opportunity for EG-70 supported by ongoing bladder cancer clinical studies ONCOLOGY Therapeutic Area and Program Administration Discovery IND-Enabling Phase 1/2 Phase 3 Anticipated Milestones Expected timelines and anticipated milestones reflect enGene management's current estimate and are subject to change HR BCG-naïve and exposed NMIBC Enrollment to commence Q4 2024 HR BCG-unresponsive NMIBC, papillary-only Cohort is registrational

EG-70 (detalimogene voraplasmid): addressing unmet needs in NMIBC

Potential multi-billion dollar market opportunity addressing the unmet needs in NMIBC 1SEER database, 2023 figure; 2Mossanen and Gore, Curr Opin Urol 2014 >82K new diagnoses of bladder cancer per year in USA,1 of which an estimated 21K-24K are high-risk NMIBC Highest cost of all cancers to treat2 BCG shortage has created a public health crisis and unmet need across the care continuum Potential near-term enGene market entry via BCG-unresponsive NMIBC 50% of patients fail BCG, the only approved first-line treatment Radical cystectomy is standard to prevent muscle invasion after BCG failure Avoiding cystectomy is goal of therapy in BCG-unresponsive NMIBC, per FDA guidance Urologists seek to exhaust intravesical options prior to resorting to radical cystectomy Community urologists typically treat NMIBC, not oncologists

EG-70: Designed to eradicate tumors via synergistic stimulation of bladder-specific innate and adaptive immune responses Innate immune system activation: Dual RIG-I agonists NK cell stimulation and suppressor cell attenuation promotes tumor killing Historical clinical data w/ innate immune activators support biological rationale Stimulates T cell recruitment and neo-antigen presentation Adaptive immune system activation: Secreted IL-12 T-cell dependent cytokine response promotes tumor killing, immune memory Bladder-restricted production has potential to drive strong therapeutic effect while reducing potential for systemic adverse events EG-70 lyophilized powder

Patient / clinician-friendly profile ideal for community urology clinics Product Attribute EG-70 cretostimogene Adstiladrin TAR-200 Does not require repeated burdensome placement and removal of indwelling intravesical device    X Active ingredient not used in earlier lines of therapy    X Common storage conditions (no -80C requirement)  X X  No required detergent bladder wash steps  X   Universal biosafety precautions not required  Not yet reported* X  No potentially immunogenic viral capsid in product  X X  * Detailed handling instructions have not yet been reported for cretostimogene. BSL2-like handling recommendations are likely based on precedent described in USPI for Imlygic, an FDA-approved, locally administered oncolytic virus.

EG-70 is designed to streamline administration and ease the experience for patients and clinicians †† Based on USPI. * Based on USPI. Note: Once thawed, Adstiladrin vial must be used within 24 hours. Adstiladrin prescribing information also advises that “persons who are immunocompromised or immunodeficient may be at risk for disseminated infection from ADSTILADRIN due to low levels of replication-competent adenovirus.” ** BSL2-like handling recommendations are likely based on precedent described in USPI for Imlygic, an FDA-approved, locally administered oncolytic virus. Detailed thaw, preparation, and/or administration instructions have not yet been reported for cretostimogene. Other information based on CG Oncology’s non-confidential investor presentation Cretostimogene dwell (45-60m) DDM Re-infusion and dwell (15m) Saline Wash DDM Wash Saline Wash Preparation: BSL2-like handling likely recommended** Cretostimogene: (Based on publicly available data): Complex process with unclear vial thaw, biosafety, and urine decontamination requirements ~10m thaw Urine bleaching requirements not reported Adstiladrin instillation and dwell (60m)* 3-10 hour vial thaw* Adstiladrin: Vial thaw introduces preparation bottleneck; elevated biosafety procedures required; additional pre/post treatment burden for patients Anticholinergic premedication* 48-hour period of required urine bleaching* Preparation: “Universal biosafety precautions” required; USPI contains infection risk warning* 6-hour period of required urine bleaching †† BCG-TICE: Risk of infection for patients and caregivers; longer, uncomfortable dwell time; urine decontamination burden Preparation: mask/gown minimally required †† BCG instillation and dwell (120m) †† EG-70 instillation and dwell (60m) EG-70: As designed, no vial thaw, simple preparation; no pre/post treatment protocol Preparation: can be conducted on open table or benchtop; no special handling (No post-treatment urine bleaching required)

FDA guidance: Use of a single-arm, open-label design is appropriate for approval for BCG-unresponsive NMIBC Clearly defined patient population and entry criteria for BCG-unresponsive NMIBC provided by guidance Approval based on complete response rate, duration of response, and safety Pivotal Phase 2 design is consistent with FDA guidance

Phase 1/2 combined registrational study design and fast track designation support BLA submission in mid-2026 Phase 1: Primary, Secondary Endpoints - Completed Phase 2, Cohort 1: Interim Data – Mid 2024 N = ~100 *RP2D is Recommended Phase 2 Dose; ** CR is complete response Expected timelines and anticipated milestones reflect enGene management's current estimate and are subject to change. Patients: High-risk NMIBC failed BCG, with Cis EG-70 Dosing: 2 or 4 doses in 12-week cycle Cohorts: 3+3 dose escalation (4 dose levels) Endpoints: 1° - Safety; 2° - Efficacy Patients: High-risk NMIBC failed BCG, with Cis EG-70 Dosing: 4x800ug at weeks 1,2,5,6 Q3M Cohorts: Single-arm, open label Endpoints: 1° - CR** rate at 12-months; 2° - safety and durability

Data from ongoing Phase 1: 73% complete response (CR) rate at any time Data cutoff 8.22.2023; **E means ‘expansion’; †, Patient or physician declined to continue on investigational agent to pursue other modes of treatment (e.g., surgery) † †, One additional patient was dosed in this group but later deemed by the independent DSMB to be ineligible and excluded from ‘efficacy set’

Urine and plasma analysis demonstrate organ-localized production of IL-12 and support Phase 2 dose selection Treatment Day 1 3 8 10 15 43 64 0.1 1 10 100 1000 Dose Level 1 Dose Level 2 Dose Level 3 Urine IL-12 in Phase 1 dose-escalation 1st dose 2nd dose *Slide reflects all data available as of November 2022. Urine collected prior to dosing No clinically significant IL-12 detected in plasma Urine IL-12 levels in dose level 2 are an order of magnitude higher than dose level 1 No further increases in IL-12 production with dose level 3

No DLTs observed in Phase 1: EG-70’s safety profile allowed rational Ph2dose selection based on efficacy & biomarkers, not toxicity1 Confidential ©2024 1. Kalota S, et al. AUA Annual Meeting 2024 Promising safety and tolerability profile No safety-related patient discontinuations Reversible and largely consistent with catheterization Patients with TRAEs, n (%) Grade 1 (Mild) Grade 2 (Moderate) Grade 3 (Severe) Grades 4 or 5 (life-threatening or death) Hematuria 3 (12.5) 0 (0.0) 0 (0.0) 0 (0.0) Urinary tract infection 0 (0.0) 3 (12.5) 0 (0.0) 0 (0.0) Micturition urgency 2 (8.3) 1 (4.2) 0 (0.0) 0 (0.0) Dysuria 3 (12.5) 0 (0.0) 0 (0.0) 0 (0.0) Fatigue 2 (8.3) 0 (0.0) 0 (0.0) 0 (0.0) Nocturia 2 (8.3) 0 (0.0) 0 (0.0) 0 (0.0) Pyrexia 2 (8.3) 0 (0.0) 0 (0.0) 0 (0.0) Renal failure* 0 (0.0) 0 (0.0) 1 (4.2) 0 (0.0) Patients with  TRAEs, n (%) N=24 Any 13 (54.2) Grade 1 11 (45.8)  Grade 2 7 (29.2) Grade 3 1 (4.2) Grade 4/5 0 (0.0) All TRAEs1 *Patient had a history of renal failure and recurrent obstructive uropathy with presence of bilateral hydroureteronephrosis at screening – enrollment criteria later modified and excludes patients with a history of unresolved vesicoureteral reflux, indwelling urinary catheter or unresolved hydronephrosis due to ureteral obstruction

EG-70’s selected Phase 2 dose demonstrates a potentially promising efficacy and durability profile EG-70 cretostimogene* Adstiladrin** Mechanism of Action Non-viral, non-integrating gene therapy Viral Oncolytic immunotherapy Viral gene therapy secreting IFN Trial LEGEND BOND-003 CS-003 Data Summarized Phase 1 RP2D (Combined DL2’+DL2’ expansion cohorts) Phase 3 Phase 3 Cohort Size n=10 n=105 n=98 CR at 3 months 70% (7/10) 62% NR (51% CR Rate at any time) CR Rate at 6 months 60% (6/10) 65% NR (9.7 month mDOR based on patients that achieved a CR, n=50) mDOR = Median duration of response; RP2D = recommended phase 2 dose * Based on swimmer’s plot data from CG Oncology’s May 2024 AUA presentation, as analyzed and calculated by enGene ** Based on Adstiladrin USPI

LEGEND seeks to establish EG-70 as the cornerstone of a non-viral bladder cancer franchise HR BCG Naïve & Exposed NMIBC Other bladder applications (Example: IR NMIBC, MIBC) Other GU cancers Papillary-only expansion of LEGEND study designed to increase potential EG-70 use across entire HR NMIBC 21K-24K patient population (est) First of several planned expansions: Streamlined product profile supports broad use in the bladder and beyond IP fortress through at least 2040 HR BCG unresponsive NMIBC IR NMIBC = Intermediate Risk Non-Muscle Invasive Bladder Cancer; MIBC = Muscle Invasive Bladder Cancer Current focus of LEGEND study

NMIBC = Non-muscle invasive bladder cancer; BCG = Bacillus Calmette-Guerin; BLA = Biologics License Application; COGS = Cost of Goods Sold Expected timelines and anticipated milestones reflect enGene management's current estimate and are subject to change.  Summary: Moving genetic medicines into the mainstream Highly differentiated program designed for community urologists: Single-step administration, more patient-friendly, no onerous viral containment / handling requirements Profile supportive of expansive applications across bladder cancer: Product candidate attributes conducive to broad physician adoption Non-viral platform supports low COGS and scalable manufacturing: Polymeric nanoparticle with non-integrating DNA cargo; already scaled for US launch Multiple anticipated value inflection points: Phase 2 interim efficacy data expected by end of September 2024 and mid-2026 BLA

Corporate Presentation June 2024

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Document and Entity Information	Jun. 14, 2024
Document And Entity Information [Line Items]
Document Type	8-K
Document Period End Date	Jun. 14, 2024
Entity Registrant Name	enGene Holdings Inc.
Entity Incorporation State Country Code	A1
Entity File Number	001-41854
Entity Tax Identification Number	00-0000000
Entity Address Address Line 1	4868 Rue Levy, Suite 220
Entity Address City Or Town	Saint-Laurent
Entity Address State Or Province	QC
Entity Address Country	CA
Entity Address Postal Zip Code	H4R 2P1
City Area Code	514)
Local Phone Number	332-4888
Written Communications	false
Soliciting Material	false
Pre Commencement Tender Offer	false
Pre Commencement Issuer Tender Offer	false
Entity Emerging Growth Company	true
Entity Ex Transition Period	true
Entity Central Index Key	0001980845
Amendment Flag	false
Common Stock [Member]
Document And Entity Information [Line Items]
Security 12b Title	Common Shares
Trading Symbol	ENGN
Security Exchange Name	NASDAQ
Warrant [Member]
Document And Entity Information [Line Items]
Security 12b Title	Warrants, each exercisable for one Common Share, at an exercise price of $11.50 per Common Share
Trading Symbol	ENGNW
Security Exchange Name	NASDAQ