enGene Holdings Inc.

Previous wording

Our detalimogene program is currently enrolling patients in a combined Phase 1/2 open-label study with a pivotal cohort, referred to as “LEGEND”. The Phase 2 portion of LEGEND is enrolling three cohorts: cohort 1 is a pivotal cohort enrolling BCG-unresponsive NMIBC patients with CIS; cohort 2 is enrolling BCG-naïve NMIBC patients with CIS (cohort 2a) and BCG-exposed NMIBC patients with CIS (cohort 2b); and cohort 3 is enrolling patients with BCG-unresponsive NMIBC who have papillary disease only (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 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.

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, 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. 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.

Previous wording

We have never been profitable and have incurred net losses since inception. Our net loss was $25.8 million and $50.4 million for the three and six months ended April 30, 2025 and $15.0 million and $25.7 million for the three and six months ended April 30, 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 mid-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 $29.0 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.

Previous wording

As of April 30, 2025, we had $251.5 million in cash, cash equivalents and marketable securities. We believe that our existing cash and cash equivalents as of April 30, 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 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.

Previous wording

Comparison of the three and six months ended April 30, 2025 and 2024

Current wording

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

Previous wording

Research and development expenses increased by $10.4 million from $9.9 million for the three months ended April 30, 2024 to $20.2 million for the three months ended April 30, 2025. This increase was attributable to the following:

Current 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:

Previous wording

a $6.5 million increase in detalimogene direct expense as a result of our increasing manufacturing and clinical activities to advance our LEGEND study of detalimogene, as well as in preparation for our planned Biologics License Application submission; and

Current wording

a $6.9 million increase in detalimogene direct expense as a result of our increasing manufacturing and clinical activities to advance our LEGEND study of detalimogene, as well as in preparation for our planned Biologics License Application submission;

Previous wording

a $2.8 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.

Current 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

Previous wording

Research and development expenses increased by $24.7 million from $15.5 million for the six months ended April 30, 2024 to $40.2 million for the six months ended April 30, 2025. This increase was attributable to the following:

Current wording

Research and development expenses increased by $35.7 million from $27.0 million for the nine months ended July 31, 2024 to $62.8 million for the nine months ended July 31, 2025. This increase was attributable to the following:

Previous wording

a $19.3 million increase in detalimogene direct expense as a result of our increasing clinical and manufacturing activities to advance our LEGEND study of detalimogene, as well as in preparation for our planned Biologics License Application submission; and

Current wording

a $26.2 million increase in detalimogene direct expense as a result of our increasing clinical and manufacturing activities to advance our LEGEND study of detalimogene, as well as in preparation for our planned Biologics License Application submission;

Previous wording

a $4.5 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.

Current wording

a $7.9 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

Previous wording

General and administrative expenses decreased by $0.5 million from $7.5 million for the three months ended April 30, 2024 to $6.9 million for the three months ended April 30, 2025. This decrease was primarily attributable to the following:

Current 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:

Previous wording

a $1.4 million increase in personnel-related expenses driven by the hiring of key general and administrative personnel necessary to support the operation of a public company.

Current wording

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

Previous wording

General and administrative expenses increased by $1.0 million from $12.6 million for the six months ended April 30, 2025 to $13.6 million for the six months ended April 30, 2025. This increase was primarily attributable to the following:

Current wording

General and administrative expenses increased by $3.1 million from $17.8 million for the nine months ended July 31, 2024 to $20.9 million for the nine months ended July 31, 2025. This increase was primarily attributable to the following:

Previous wording

a $4.2 million increase in personnel-related expenses driven by the hiring of key general and administrative personnel necessary to support the operation of a public company; partially offset by

Current wording

a $5.7 million increase in personnel-related expenses driven by the hiring of key general and administrative personnel; partially offset by

Previous wording

a $1.3 million decrease in professional fees driven by the transition of work to internal resources and higher costs in 2024 due to accounting and finance fees to support the first year operating as a public company; and

Current wording

a $1.3 million decrease in professional fees driven by the transition of work to internal resources and higher costs in 2024 due to accounting and finance fees to support the first year operating as a public company;

Previous wording

a $1.3 million decrease in legal fees due to legal review of the PIPE financing and debt agreements and Form S-1 in 2024.

Current wording

a $1.1 million decrease in legal fees due to legal review of the PIPE financing and debt agreements and Form S-1 in 2024; and

Previous wording

Other income decreased by approximately $0.8 million from income of $2.3 million for the three months ended April 30, 2024 to income of $1.5 million for the three months ended April 30, 2025, primarily due to a $0.5 million decrease in interest income earned in the current period and $0.3 million increase in other expense primarily related to foreign currency fluctuations.

Current 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.

Previous wording

Other income increased by approximately $1.2 million from income of $2.4 million for the six months ended April 30, 2024 to income of $3.6 million for the six months ended April 30, 2025, primarily due to a $1.2 million increase in interest income earned in the current period from larger cash and marketable securities balances.

Current wording

Other income decreased by approximately $0.2 million from income of $5.0 million for the nine months ended July 31, 2024 to income of $4.8 million for the nine months ended July 31, 2025, primarily due to a $0.2 million increase in interest expense on a larger debt balances and $0.4 million increase in other expense primarily related to foreign currency fluctuations partially offset by the $0.4 change on loss on extinguishment of debt.

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 April 30, 2025, we had cash, cash equivalents and marketable securities of approximately $251.5 million, and we had an accumulated deficit of $305.2 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 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.

Previous wording

Our primary uses of capital are, and we expect will continue to be, research and development activities, compensation and related expenses and general overhead costs. We expect to continue to incur significant expenses and operating losses for the foreseeable future.

Current wording

Our primary uses of capital are, and we expect will continue to be, research and development activities, compensation and related expenses and general overhead costs. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We anticipate that our expenses will increase significantly in connection with our ongoing activities. As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy.

Previous wording

Net cash used in operating activities for the six months ended April 30, 2025 was $48.6 million and was primarily due to our net loss of $50.4 million, partially offset by adjustments for non-cash charges totaling $2.9 million. Further changes were driven by a $0.6 million decrease in net working capital adjustments.

Current 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.

Previous wording

Net cash used in operating activities for the six months ended April 30, 2024 was $21.5 million and was primarily due to our net loss of $25.7 million, partially offset by adjustments for non-cash charges totaling $3.2 million. Further changes were driven by a $1.0 million increase in net working capital adjustments.

Current 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.

Previous wording

Net cash used in investing activities for each of the six months ended April 30, 2025 and 2024 was $67.0 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 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.

Previous wording

Net cash provided by financing activities for the six months ended April 30, 2025 was $0.2 million resulting from proceeds from exercise of stock options.

Current wording

Net cash used by financing activities for the nine months ended July 31, 2025 was $0.5 million resulting from $0.7 million repayment of the Term Loan which was partially offset by the proceeds from exercise of stock options of $0.2 million.

Previous wording

Net cash provided by financing activities for the six months ended April 30, 2024 was $205.5 million, resulting from net proceeds of $187.6 million received from the 2024 PIPE financing, $6.0 million from exercise of common share warrants, $22.5 million received from the Term Loan, which was offset by $9.4 million in principal repayments of the Prior Term Loan, $0.6 million in debt issuance costs paid as part of the Term Loan, and $0.6 million of SPAC transaction costs.

Current wording

Net cash provided by financing activities for the nine months ended July 31, 2024 was $205.6 million, primarily resulting from $200.0 million received from the February 2024 PIPE financing, which was partially offset by $12.4 million of issuance costs associated with the February 2024 PIPE financing, $22.5 million received from the Term Loan, which was offset by $9.4 million in principal repayments of the Prior Term Loan, $6.0 million from exercise of common share warrants, offset by $0.6 million in debt issuance costs paid as part of the Term Loan, and $0.6 million of SPAC transaction costs paid during the nine months ended July 31, 2024.

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 six months ended April 30, 2025 and 2024, the Company paid NTC $13 and $25 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 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

Previous wording

Our leases are comprised of all operating leases for Montreal, Canada and Waltham, MA USA office space and Montreal, Canada lab space. Please refer to Note 13 and Note 15 to our condensed consolidated financial statements included elsewhere in this Quarterly Report for expenses related to the lease obligations in three and six months ended April 30, 2025, and the future payment requirements 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. 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.

Previous wording

As of June 9, 2025, we had 51,105,201 Common Shares issued and outstanding, outstanding warrants to purchase an additional 8,449,555 Common Shares and outstanding stock options to purchase an additional 9,012,480 Common Shares. The warrants amount listed in the foregoing sentence excludes the Hercules Common Share Warrants described above under “Liquidity and Capital Resources—Cash Flows—Amended Loan and Security Agreement”.

Current 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).