enGene Holdings Inc.

Previous wording

We are a clinical-stage biotechnology company focused on developing genetic medicines to improve the lives of patients suffering from bladder cancer. We are developing non-viral genetic medicines based on our novel and proprietary dually derived chitosan, or “DDX”, gene delivery platform, which allows localized delivery of complex genetic cargos directly to mucosal tissues and other organs. Our lead product candidate, detalimogene voraplasmid, or detalimogene, formerly known as EG-70, is a therapy designed to generate a local immune reaction in proximity to tumors. We believe this enables the immune system to durably clear the tumor and develop memory to resist recurrence. Because this treatment is designed to work by delivering genetic cargo to the broader tumor tissue environment rather than tumor cells specifically, we believe it has the potential to be widely utilized across tumor types. Currently, we are developing detalimogene as a monotherapy to treat non-muscle invasive bladder cancer (“NMIBC”) with carcinoma in situ (“CIS”) in patients that have been unresponsive to treatment with Bacillus Calmette-Guérin, or “BCG,” or what is referred to as “BCG-unresponsive NMIBC with CIS.” We are also exploring the clinical application of detalimogene to other forms of NMIBC, namely, papillary-only BCG-unresponsive NMIBC (i.e., NMIBC without CIS), as well as BCG-naïve NMIBC patients with CIS and BCG-exposed NMIBC patients with CIS (i.e., patients who have been treated with some BCG but who do not qualify as BCG-unresponsive in accordance with FDA and urology practice guidelines).

Current wording

We are a clinical-stage biotechnology company mainstreaming genetic medicine 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, beginning with non-muscle invasive bladder cancer ("NMIBC"). We are developing non-viral genetic medicines based on our novel and proprietary dually derived chitosan, or “DDX”, gene delivery platform, which allows localized delivery of complex genetic cargos directly to mucosal tissues and other organs. Our lead product candidate, detalimogene voraplasmid, or detalimogene, formerly known as EG-70, is a therapy designed to promote a pro-inflammatory, anti-tumor microenvironment throughout the bladder urothelium. We believe this enables the immune system to durably clear the tumor and develop memory to resist recurrence. Because this treatment is designed to work by delivering genetic cargo to the broader tumor tissue environment rather than tumor cells specifically, we believe it has the potential to be utilized across a variety of tumor types. Currently, we are developing detalimogene as a monotherapy to treat NMIBC with carcinoma in situ (“CIS”) with or without concomitant papillary disease in patients that have been unresponsive to treatment with Bacillus Calmette-Guérin, or “BCG,” or what is referred to as “BCG-unresponsive NMIBC with CIS.” BCG is established as the first-line therapy for patients diagnosed with high-risk NMIBC; however, supply constraints have resulted in a shortage of BCG in the United States for over a decade. We are also exploring the clinical application of detalimogene to various additional NMIBC patient populations, namely, high-risk papillary-only BCG-unresponsive NMIBC (i.e., high-risk NMIBC without CIS), as well as high-risk BCG-naïve NMIBC patients with CIS and high-risk BCG-exposed NMIBC patients with CIS (i.e., patients who have not received an adequate course of BCG and who do not qualify as BCG-unresponsive in accordance with FDA and urology practice guidelines).

Previous wording

Detalimogene is being evaluated in the ongoing combined Phase 1/2 open-label, multi-cohort study, referred to as “LEGEND”. LEGEND’s Phase 2 pivotal cohort (cohort 1) consists of approximately 100 patients with BCG-unresponsive NMIBC with CIS (with or without papillary disease) and is designed to serve as the basis of our planned biologics license application, if the data are positive. In addition to this pivotal cohort, LEGEND includes three additional cohorts, cohort 2a for patients with BCG-naïve NMIBC with CIS, cohort 2b for patients with BCG-exposed NMIBC patients with CIS; and cohort 3 for patients with BCG-unresponsive NMIBC who have papillary-only disease (i.e., no CIS). In addition, our preclinical research is focused on expanding the cancer indications that can be treated with detalimogene as well as discovering new opportunities to apply our DDX technology platform to treat other indications with high unmet medical needs.

Current wording

Detalimogene is currently being studied in a combined Phase 1/2 open-label trial, referred to as “LEGEND” (ClinicalTrials.gov identifier NCT04752722). The Phase 2 portion of LEGEND is comprised of three cohorts: Cohort 1 is a pivotal cohort studying detalimogene in patients with high-risk BCG-unresponsive NMIBC with CIS with or without concomitant papillary disease for which we have completed enrollment with 125 patients; Cohort 2 is evaluating detalimogene in patients with high-risk BCG-naïve NMIBC with CIS (Cohort 2a, with 30 enrolled patients as of November 11, 2025) and patients with high-risk BCG-exposed NMIBC with CIS (Cohort 2b, with 45 enrolled patients as of November 11, 2025); and Cohort 3 is evaluating detalimogene in patients with high-risk BCG-unresponsive NMIBC who have papillary disease only (i.e., no CIS, with 36 enrolled patients as of November 11, 2025). In addition, our preclinical research is focused on expanding the cancer indications that can be treated with detalimogene as well as discovering new opportunities to apply our DDX technology platform to treat other indications with high unmet medical needs.

Previous wording

Since our inception, we have devoted substantially all of our efforts to organizing and staffing our Company, business planning, raising capital, establishing our intellectual property portfolio, acquiring or discovering product candidates, research and development activities for our primary program, detalimogene voraplasmid, or detalimogene. We do not have any products approved for sale and have not generated any revenue from product sales. We operate as a single operating segment focused on research, discovery, and clinical development of detalimogene. To date, the Company has not generated any revenues and has financed its liquidity needs primarily through PIPE financings, offering debt arrangements, and issuance of warrants.

Current wording

Since our inception, we have devoted substantially all of our efforts to organizing and staffing our Company, business planning, raising capital, establishing our intellectual property portfolio, acquiring or discovering product candidates, research and development activities for our primary program, detalimogene voraplasmid, or detalimogene. We do not have any products approved for sale and have not generated any revenue from product sales. We operate as a single operating segment focused on research, discovery, and clinical development of detalimogene. Since our merger with Forbion European Acquisition Company in 2023, we have financed the Company through a series of public and private investment in public equity (“PIPE”) financings, debt arrangements, and issuance of warrants and pre-funded warrants.

Previous wording

We have never been profitable and have incurred net losses since inception. Our net loss was $29.0 million and $79.4 million for the three and nine months ended July 31, 2025 and $14.1 million and $39.8 million for the three and nine months ended July 31, 2024, respectively. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future as we advance the ongoing LEGEND study of detalimogene, including the pivotal cohort of patients with BCG-unresponsive NMIBC, to completion; execute on our plan to file a Biologics License Application with the FDA in 2H 2026; and pursue potential pipeline expansion via additional detalimogene development opportunities and other compounds. In addition, we expect to incur significant expenses as we establish medical affairs, sales, marketing and distribution infrastructure and capabilities to support the potential commercial launch of detalimogene and significant additional commercialization-related expenses, if and when detalimogene is approved. As a result, we expect to need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity offerings and debt financings, or other capital sources, which could include potential collaboration agreements, strategic alliances, or licensing arrangements. We may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into other arrangements as and when needed would have a negative impact on our financial condition and our ability to develop our product candidates.

Current wording

We have never been profitable and have incurred net losses since inception. Our net loss was $29.8 million and $24.6 million for the three months ended January 31, 2026 and 2025, respectively. As of January 31, 2026 and October 31, 2025 we had an accumulated deficit of $401.8 million and $372.0 million, respectively, and cash, cash equivalents and marketable securities of $312.5 million and $202.3 million, respectively. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future as we advance the ongoing LEGEND study of detalimogene, including the pivotal cohort of patients with BCG-unresponsive NMIBC, to completion; execute on our plan to submit a Biologics License Application with the FDA in the second half of 2026; and pursue potential pipeline expansion via additional detalimogene development opportunities and other compounds. In addition, we expect to incur significant expenses as we establish medical affairs, sales, marketing and distribution infrastructure and capabilities to support the potential commercial launch of detalimogene and significant additional commercialization-related expenses, if and when detalimogene is approved. As a result, we expect to need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity offerings and debt financings, or other capital sources, which could include potential collaboration agreements, strategic alliances, or licensing arrangements. We may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into other arrangements as and when needed would have a negative impact on our financial condition and our ability to develop our product candidates.

Previous wording

As of July 31, 2025, we had $224.9 million in cash, cash equivalents and marketable securities. We believe that our existing cash and cash equivalents as of July 31, 2025 will be sufficient to fund our operating expenses, debt obligations, and capital expenditure requirements for at least the next 12 months from the issuance date of the condensed consolidated financial statements included within this Quarterly Report. While we have historically been successful in securing financing, raising additional funds is dependent on a number of factors outside of our control, and as such there is no assurance that we will be able to do so in the future. Refer to“Liquidity and Capital Resources”section below.

Current wording

As of January 31, 2026, we had $312.5 million in cash, cash equivalents and marketable securities. We believe that our existing cash and cash equivalents as of January 31, 2026 will be sufficient to fund our operating expenses, debt obligations, and capital expenditure requirements for at least the next 12 months from the issuance date of the condensed consolidated financial statements included within this Quarterly Report. While we have historically been successful in securing financing, raising additional funds is dependent on a number of factors outside of our control, and as such there is no assurance that we will be able to do so in the future. Refer to“Liquidity and Capital Resources”section below.

Previous wording

expenses incurred under agreements with CROs that are primarily engaged in the oversight and conduct of our clinical trials; CDMOs that are primarily engaged to provide drug substance and product for our clinical trials, research and development programs, as well as investigative sites and consultants that conduct our clinical trials, nonclinical studies and other scientific development services;

Current wording

expenses incurred under agreements with CROs that are primarily engaged in the oversight and conduct of our clinical trials; CMOs that are primarily engaged to provide drug substance and product for our clinical trials, research and development programs, as well as investigative sites and consultants that conduct our clinical trials, nonclinical studies and other scientific development services;

Previous wording

costs related to compliance with quality and regulatory requirements;

Current wording

costs associated with other research and development expenses including costs related to outside consultants, costs related to compliance with quality and regulatory requirements, payments made under third-party licensing agreements, and costs related to facilities, supplies, rent, insurance, certain legal fees.

Previous wording

A significant portion of our research and development costs to date have been third-party costs, which we track on an individual product candidate basis after a clinical product candidate has been identified. Currently, our main clinical product candidate is detalimogene. Our indirect research and development costs are primarily personnel-related costs, facilities, and other costs. Employees and infrastructure are not directly tied to any one program and are deployed across our programs. As such, we do not track these costs on a specific program basis. We utilize third party contractors for our research and development activities and CDMOs for our manufacturing activities and we do not have our own laboratory or manufacturing facilities.

Current wording

A significant portion of our research and development costs to date have been third-party costs, which we track on an individual product candidate basis after a clinical product candidate has been identified. Currently, our main clinical product candidate is detalimogene. Our indirect research and development costs are primarily personnel-related costs, facilities, and other costs. Employees and infrastructure are not directly tied to any one program and are deployed across our programs. As such, we do not track these costs on a specific program basis. We utilize third party contractors for our research and development activities and CMOs for our manufacturing activities and we do not have our own laboratory or manufacturing facilities.

Previous wording

Comparison of the three and nine months ended July 31, 2025 and 2024

Current wording

Comparison of the three months ended January 31, 2026 and 2025

Previous wording

Research and development expenses increased by $11.0 million from $11.5 million for the three months ended July 31, 2024 to $22.6 million for the three months ended July 31, 2025. This increase was attributable to the following:

Current wording

Research and development expenses increased by $2.3 million from $20.0 million for the three months ended January 31, 2025 to $22.3 million for the three months ended January 31, 2026. This increase was attributable to the following:

Previous wording

a $3.5 million increase in personnel-related costs as the Company hired a number of key personnel to ramp up its clinical operations, quality, medical affairs and manufacturing functions to support our LEGEND study of detalimogene; and

Current wording

a $2.6 million increase in personnel-related costs, including a $0.4 million increase in stock-based compensation, driven by increased headcount as the Company continues to scale its clinical operations, quality, medical affairs and manufacturing functions to support our LEGEND study of detalimogene, and increased bonus and contractor expenses; and

Previous wording

General and administrative expenses increased by $2.2 million from $5.2 million for the three months ended July 31, 2024 to $7.4 million for the three months ended July 31, 2025. This increase was primarily attributable to the following:

Current wording

General and administrative expenses increased by $2.3 million from $6.6 million for the three months ended January 31, 2025 to $8.9 million for the three months ended January 31, 2026. This increase was primarily attributable to the following:

Previous wording

a $1.5 million increase in personnel-related expenses driven by the hiring of key general and administrative personnel; and

Current wording

a $1.5 million increase in personnel-related expenses, including a $0.6 million increase in stock-based compensation, driven by the hiring of key general and administrative personnel and increased bonus and contractor expenses; and

Previous wording

Other income decreased by approximately $1.4 million from income of $2.6 million for the three months ended July 31, 2024 to income of $1.2 million for the three months ended July 31, 2025, primarily due to a $1.1 million decrease in interest income earned in the current period and $0.2 million increase in other expense primarily related to foreign currency fluctuations.

Current wording

Other income decreased by approximately $0.6 million from income of $2.0 million for the three months ended January 31, 2025 to income of $1.4 million for the three months ended January 31, 2026, primarily due to the loss on extinguishment of debt related to the Second Amendment of the Term Loan with Hercules Capital, Inc. ("Hercules").

Previous wording

Since our inception, we have incurred significant losses in each period and on an aggregate basis. We have not yet commercialized any product candidates, and we do not expect to generate revenue from sales of any product candidates or from other sources for several years, if at all. As of July 31, 2025, we had cash, cash equivalents and marketable securities of approximately $224.9 million, and we had an accumulated deficit of $334.2 million. To date, the Company has not generated any revenues and has financed its liquidity needs primarily through PIPE financings, offering debt, and issuance of warrants.

Current wording

Since our inception, we have incurred significant losses in each period and on an aggregate basis. We have not yet commercialized any product candidates, and we do not expect to generate revenue from sales of any product candidates or from other sources for several years, if at all. As of January 31, 2026, we had cash, cash equivalents and marketable securities of approximately $312.5 million, and we had an accumulated deficit of $401.8 million. To date, the Company has not generated any revenues and has financed its liquidity needs primarily through PIPE financings, offering debt, and issuance of warrants.

Previous wording

Based on our current operating plans, we expect our cash, cash equivalents and marketable securities as of July 31, 2025 will be sufficient to fund the Company’s operating expenses and debt obligations requirements for at least the next 12 months from the issuance date of the condensed consolidated financial statements included within this Quarterly Report, without giving effect to $27.5 million we may be eligible to drawdown further under our debt facility with Hercules and the $100.0 million limit under our Open Market Sale Agreement with Jefferies LLC, which was entered into on December 20, 2024. Our current operating plan is based on various assumptions. If we use our capital resources sooner than expected, we will evaluate reductions in expense or obtaining additional financing. This may include pursuing a combination of public or private equity offerings, debt financings, collaborations, strategic alliances or licensing arrangements with third parties. There can be no assurance that such financing will be available in sufficient amounts or on acceptable terms, if at all, and some could be dilutive to existing stockholders. If we are unable to obtain additional funding on a timely basis, we may be forced to significantly curtail, delay, or discontinue one or more of our planned research or development programs or be unable to expand our operations.

Current wording

Based on our current operating plans, we expect our cash, cash equivalents and marketable securities as of January 31, 2026 will be sufficient to fund the Company’s operating expenses and debt obligations requirements for at least the next 12 months from the issuance date of the condensed consolidated financial statements included within this Quarterly Report, without giving effect to $100.0 million we may be eligible to drawdown further under our debt facility with Hercules, subject to achieving the milestones therein. Our current operating plan is based on various assumptions. If we use our capital resources sooner than expected, we will evaluate reductions in expense or obtaining additional financing. This may include pursuing a combination of public or private equity offerings, debt financings, collaborations, strategic alliances or licensing arrangements with third parties. There can be no assurance that such financing will be available in sufficient amounts or on acceptable terms, if at all, and some could be dilutive to existing stockholders. If we are unable to obtain additional funding on a timely basis, we may be forced to significantly curtail, delay, or discontinue one or more of our planned research or development programs or be unable to expand our operations.

Previous wording

Net cash used in operating activities for the nine months ended July 31, 2025 was $74.3 million and was primarily due to our net loss of $79.4 million, partially offset by adjustments for non-cash charges totaling $5.5 million. Further changes were driven by a $0.4 million decrease in net working capital adjustments.

Current wording

Net cash used in operating activities for the three months ended January 31, 2026 was $28.9 million and was primarily due to our net loss of $29.8 million, partially offset by adjustments for non-cash charges totaling $3.4 million. Further changes were driven by a $2.5 million increase in net working capital adjustments.

Previous wording

Net cash used in operating activities for the nine months ended July 31, 2024 was $28.7 million and was primarily due to our net loss of $39.8 million, partially offset by adjustments for non-cash charges totaling $5.0 million. Further changes were driven by the receipt of a $2.1 million refundable investment tax credit and a $4.0 million increase in net working capital adjustments.

Current wording

Net cash used in operating activities for the three months ended January 31, 2025 was $25.7 million and was primarily due to our net loss of $24.6 million, partially offset by adjustments for non-cash charges totaling $1.5 million. Further changes were driven by a $2.6 million increase in net working capital adjustments.

Previous wording

Net cash used in investing activities for each of the nine months ended July 31, 2025 and 2024 was $65.6 million and $0.7 million, respectively, consisting of net purchases of marketable securities and property and equipment.

Current wording

Net cash used in investing activities for each of the three months ended January 31, 2026 and 2025 was $126.3 million and $85.0 million, respectively, consisting of net purchases of marketable securities and property and equipment.

Previous wording

The Company has entered into a debt facility with Hercules, under which we have drawn $22.5 million and may be able to draw an additional $27.5 million, subject to the terms and conditions of the Hercules Term Loan. Refer to disclosures in Note 8 to our condensed consolidated financial statements included elsewhere in this Quarterly Report for the terms and conditions of the Hercules debt facility, as well as the estimated cashflow payment requirements needed to satisfy the Company’s debt obligations as of July 31, 2025.

Current wording

The Company has entered into a debt facility with Hercules, under which we have drawn $25.0 million and may be able to draw an additional $100.0 million, subject to the terms and conditions of the Second Amended Loan Agreement with Hercules. Refer to disclosures in Note 8 to our condensed consolidated financial statements included elsewhere in this Quarterly Report for the terms and conditions of the Hercules debt facility, as well as the estimated cashflow payment requirements needed to satisfy the Company’s debt obligations as of January 31, 2026.

Previous wording

On April 10, 2020, we entered into the License Agreement with NTC pursuant to which NTC granted us a worldwide non-exclusive, royalty-bearing and sublicensable license to certain patents and know-how relating to the Nanoplasmid™ vector backbone that is used in detalimogene voraplasmid to research, develop, make, use, import, sell and offer and sell, any gene and cell therapy products incorporating the Nanoplasmid™ vector backbone (excluding any such products in the field of dermatology). Unless terminated earlier, the License Agreement will continue until no valid claim of any licensed patent exists in any country. We can voluntarily terminate the License Agreement with prior notice to NTC. During the three and nine months ended July 31, 2025 and 2024, the Company paid NTC $13 and $38 thousand related to the annual maintenance fee under the terms of agreement, respectively

Current wording

On April 10, 2020, we entered into the License Agreement with NTC pursuant to which NTC granted us a worldwide non-exclusive, royalty-bearing and sublicensable license to certain patents and know-how relating to the Nanoplasmid™ vector backbone that is used in detalimogene voraplasmid to research, develop, make, use, import, sell and offer and sell, any gene and cell therapy products incorporating the Nanoplasmid™ vector backbone (excluding any such products in the field of dermatology). Unless terminated earlier, the License Agreement will continue until no valid claim of any licensed patent exists in any country. We can voluntarily terminate the License Agreement with prior notice to NTC. During the three months ended January 31, 2026 and 2025, the Company paid NTC $13 thousand related to the annual maintenance fee under the terms of agreement, respectively, and incurred $128.3 thousand related to the manufacturing payment under the License Agreement during the three months ended January 31, 2026.

Previous wording

Our leases are comprised of all operating leases for Montreal, Canada, Boston, MA USA and Waltham, MA USA office space and Montreal, Canada lab space. Please refer to Note 13 to our condensed consolidated financial statements included elsewhere in this Quarterly Report for expenses related to the lease obligations in the three and nine months ended July 31, 2025, future payment requirements, and the guaranty obligations under the lease agreements.

Current wording

Our leases are comprised of all operating leases for Montreal, Canada, Boston, MA USA and Waltham, MA USA office space and Montreal, Canada lab space. Refer to Note 13 to our condensed consolidated financial statements included elsewhere in this Quarterly Report for expenses related to the lease obligations in the three months ended January 31, 2026, future payment requirements, and the guaranty obligations under the lease agreements.

Previous wording

As of September 10, 2025, we had 51,191,771 Common Shares issued and outstanding, outstanding warrants to purchase an additional 8,449,555 Common Shares, outstanding stock options to purchase an additional 9,322,091 Common Shares and outstanding ESPP to purchase an additional 2,000,000 Common Shares. The warrants amount listed in the foregoing sentence excludes the Hercules Common Share Warrants (as described above in Note 8 to our condensed consolidated financial statements included elsewhere in this Quarterly Report).

Current wording

As of March 3, 2026, we had 66,989,466 Common Shares issued and outstanding, restricted share units of 272,925 Common Shares, outstanding public warrants to purchase an additional 8,449,555 Common Shares, outstanding warrants issued to Hercules as part of our debt facility to purchase an additional 103,263 Common Shares, outstanding pre-funded warrants to purchase an additional 2,735,295 Common Shares, and outstanding stock options to purchase an additional 12,076,920 Common Shares.