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enGene Therapeutics Inc.

For the period ended Jul 31, 2026. Filed Sep 8, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jul 31, 2026 · Filed Sep 8, 2026

ENGN$1.75+4.2%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-04-30; filed 2026-06-15.

0001193125-26-270386

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-07-31; filed 2026-09-08.

0001193125-26-384383

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 141 previous paragraphs and 147 current paragraphs.

100 unchanged; 33 reworded; 13 added; 8 removed; 0 previous and 1 current paragraphs rearranged.

Tables are not compared: 4 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (13)

Current report

In connection with the strategic restructuring, the Company approved retention incentives intended to retain key employees through specified clinical and regulatory objectives. As further described below, these retention incentives are separate from one-time termination benefits and include performance-based cash retention awards and performance-based equity retention awards, each of which requires continued employment and is contingent on the achievement of specified milestones.

Current report

On June 16, 2026, the compensation committee of the board of directors approved the issuance of performance-based equity retention awards under the 2023 Plan to certain executive employees and non-executive employees, to be issued in the form of performance-based non-qualified stock options and performance-based restricted share units. Subject to the applicable recipient remaining actively employed and in good standing with the Company, the awards will vest, if at all, based upon the achievement of two milestones: (i) confirmation from the FDA that the Company’s BLA filing with respect to detalimogene has been completed and accepted by the FDA, provided that such confirmation is received by September 30, 2027, and (ii) FDA regulatory approval with respect to detalimogene, provided that such regulatory approval is received by December 31, 2028.

Current report

The Company estimates that it will incur up to approximately $2.8 million in non-cash stock-based compensation expense in connection with the vesting of performance-based equity retention awards, with approximately $1.4 million of non-cash stock-based compensation expense recognized upon vesting for each milestone.

Current report

Comparison of the three and nine months ended July 31, 2026 and 2025

Current report

Certain amounts reported in prior years have been reclassified to conform to the current year's presentation.

Current report

Research and development expenses decreased by $2.5 million from $22.6 million for the three months ended July 31, 2025 to $20.1 million for the three months ended July 31, 2026. This decrease was primarily attributable to the following:

Current report

Certain amounts reported in prior years have been reclassified to conform to the current year's presentation.

Current report

a $6.3 million increase in personnel-related expenses, including a $4.0 million increase in stock-based compensation, driven by costs related to the workforce reduction announced in June 2026 and, for a portion of the year, increased headcount.

Current report

a $9.1 million increase in personnel-related expenses, including a $5.3 million increase in stock-based compensation, driven by costs related to the workforce reduction announced in June 2026 and, for a portion of the year, increased headcount; and
Removed paragraphs (8)

Previous report

Comparison of thethree and six months ended April 30, 2026 and 2025

Previous report

a $0.6 million increase in clinical operations resulted from our increasing clinical trial activities including complete enrollment of the pivotal cohort of the Phase 2 LEGEND study of detalimogene in BCG-unresponsive NMIBC; partially offset by

Previous report

Research and development expenses increased by$4.3 million from$40.2 million for thesix months ended April 30, 2025 to$44.5 million for thesix months ended April 30, 2026. This increase was attributable to the following:

Previous report

a $5.3 million increase in personnel-related costs, including a $1.1 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 report

a $1.1 million increase in clinical operations resulted from our increasing clinical trial activities including complete enrollment of the pivotal cohort of the Phase 2 LEGEND study of detalimogene in BCG-unresponsive NMIBC; partially offset by

Previous report

a $2.8 million increase in personnel-related expenses, including a $1.4 million increase in stock-based compensation, driven by the hiring of key general and administrative personnel and increased bonus and contractor expenses; and

Previous report

a $2.4 million increase in other general and administrative expense, driven by increased facilities costs and outside services related to global commercialization.
Reworded paragraphs (33)

Previous wording

Within the United States, we estimate that there are approximately 85,000 new patients each year diagnosed with bladder cancer, of which up to 80% present with non-muscle invasive disease. Bladder cancer also poses a long-term management burden with an estimated 730,000 people living with disease.

Current wording

Within the United States, we estimate that there are approximately 90,000 new patients each year diagnosed with bladder cancer, of which up to 80% present with non-muscle invasive disease. Bladder cancer also poses a long-term management burden with an estimated 740,000 people living with disease.

Previous wording

In May 2026, we reported updated interim results from the pivotal cohort of the LEGEND trial. As of April 21, 2026, detalimogene demonstrated an any-time complete response (“CR”) rate of 54.0% among evaluable patients, with CR rates of 43.0%, 32.7%, and 13.3% at six, nine, and twelve months, respectively. Kaplan-Meier estimated CR rates were 39.4%, 31.6%, and 24.5% at six, nine, and twelve months, respectively. The data remains subject to ongoing data collection and cleaning.

Current wording

In May 2026, we reported updated interim results from the pivotal cohort of the LEGEND trial. As of April 21, 2026, detalimogene demonstrated an any-time complete response (“CR”) rate of 54.0% among evaluable patients, with CR rates of 43.0%, 32.7%, and 13.3% at six, nine, and twelve months, respectively. Kaplan-Meier estimated CR rates were 39.4%, 31.6%, and 24.5% at six, nine, and twelve months, respectively. The trial results remain subject to ongoing data collection and cleaning.

Previous wording

Further, as part of cash conservation efforts, the Company has stopped enrollment in all additional cohorts of the LEGEND trial and plans to reevaluate its strategy for these cohorts following discussion with the FDA in the second half of 2026. We expect 12-month complete response data for the pivotal cohort of the Phase 2 LEGEND trial, engagement with the FDA regarding our planned BLA filing, and to initiate a BLA submission in the second half of 2026.

Current wording

Further, as part of cash conservation efforts, the Company has stopped enrollment in all additional cohorts of the LEGEND trial and plans to reevaluate its strategy for these cohorts following discussion with the FDA in the fourth quarter of calendar year 2026. We expect updated data on key regulatory endpoints for the pivotal cohort of the Phase 2 LEGEND trial, engagement with the FDA regarding our planned BLA filing, and to initiate a BLA submission in the fourth quarter of calendar year 2026.

Previous wording

On June 15, 2026, we announced the implementation of a plan to reduce our workforce by approximately 50% to streamline operations and preserve cash. The Company’s board of directors approved this strategic restructuring, effective June 14, 2026, in order to preserve shareholder capital as the Company awaits additional durability data and meetings with the FDA in connection with the Company’s LEGEND pivotal cohort. The Company has retained personnel and resources required to meet its key strategic goals and milestones, including completion of the LEGEND Cohort 1; enrolling the detalimogene plus surfactant cohort; meeting with the FDA and planning for BLA initiation in the second half of 2026; and completing necessary pre-commercial activities required to support the commercial launch of detalimogene in 2027, if approved. The Company currently estimates it will incur restructuring costs of approximately $5.7 to $6.4 million, consisting primarily of employee severance, benefits, and other related costs, as well as approximately $4.7 million to $5.0 million in non-cash stock-based compensation expense primarily associated with accelerated vesting of stock options.

Current wording

On June 15, 2026, we announced the implementation of a plan to reduce our workforce by approximately 50% to streamline operations and preserve cash. The Company’s board of directors approved this strategic restructuring, effective June 14, 2026, in order to preserve shareholder capital as the Company awaits additional durability data and meetings with the FDA in connection with the Company’s LEGEND pivotal cohort. The Company has retained personnel and resources required to meet its key strategic goals and milestones, including completion of the LEGEND Cohort 1; enrolling the detalimogene plus surfactant cohort; meeting with the FDA and planning for BLA initiation in the fourth quarter of calendar year 2026; and completing necessary pre-commercial activities required to support the commercial launch of detalimogene in 2027, if approved. The Company currently estimates it will incur restructuring costs of approximately $5.6 million to $6.1 million, consisting primarily of employee severance, benefits, and other related costs, as well as approximately $5.0 million to $5.5 million in non-cash stock-based compensation expense primarily associated with accelerated vesting of stock options. As of July 31, 2026, $5.2 million in employee termination benefits and $3.4 million in non-cash stock-based compensation expense related to the restructuring had been incurred. The remaining expense is expected to be incurred in the fourth quarter of 2026 and includes expenses for individuals who were notified but had not left the company as of July 31, 2026.

Previous wording

The estimated charges that the Company expects to incur as a result of the restructuring are subject to several assumptions, and actual results may differ materially from these estimates. The Company may incur additional costs due to events associated with or resulting from the strategic restructuring and workforce reduction. The Company expects to record the majority of these expenses in the second half of 2026.

Current wording

The estimated charges that the Company expects to incur as a result of the restructuring are subject to several assumptions, and actual results may differ materially from these estimates. The Company may incur additional costs due to events associated with or resulting from the strategic restructuring and workforce reduction.

Previous wording

Further, in connection with the strategic restructuring, on June 14, 2026, the Company’s board of directors approved performance-based cash retention bonus awards for certain executive employees and the non-executive employees of the Company. Subject to remaining actively employed and in good standing with the Company, aggregate cash retention bonus awards of approximately $1.7 million will be paid upon the achievement of two milestones: (i) the completion of the pre-BLA meeting with the FDA relating to detalimogene on or prior to December 31, 2026 and (ii) confirmation from the FDA that the Company’s filing of the BLA with the FDA with respect to detalimogene has been completed and accepted by the FDA, provided that such confirmation is received by the Company from the FDA no later than September 30, 2027.

Current wording

On June 14, 2026, the Company’s board of directors approved performance-based cash retention awards for certain executive employees and the non-executive employees of the Company. Subject to remaining actively employed and in good standing with the Company, aggregate cash retention awards of approximately $1.6 million will be paid upon the achievement of two milestones: (i) completion of the pre-BLA meeting with the FDA relating to detalimogene on or prior to December 31, 2026, and (ii) confirmation from the FDA that the Company’s filing of the BLA with the FDA with respect to detalimogene has been completed and accepted by the FDA, provided that such confirmation is received by the Company from the FDA no later than September 30, 2027.

Previous wording

We have never been profitable and have incurred net losses since inception. Our net loss was $30.2 million and $60.0 million for the three and six months ended April 30, 2026 and $25.8 million and $50.4 million for the three and six months ended April 30, 2025, respectively. As of April 30, 2026 and October 31, 2025 we had an accumulated deficit of $432.0 million and $372.0 million, respectively, and cash, cash equivalents and marketable securities of $285.2 million and $202.3 million, respectively. We expect to continue to incur significant expenses and 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; enrolling the detalimogene plus surfactant cohort; meeting with the FDA and planning for potential BLA initiation in the second half of 2026; and completing necessary manufacturing processes and pre-commercial activities required to support the potential approval of commercial launch of detalimogene in 2027, if approved. As a result, we expect to need additional funding to support our continuing operations and pursue our strategy.

Current wording

We have never been profitable and have incurred net losses since inception. Our net loss was $32.5 million and $92.5 million for the three and nine months ended July 31, 2026, respectively, and $29.0 million and $79.4 million for the three and nine months ended July 31, 2025, respectively. As of July 31, 2026 and October 31, 2025 we had an accumulated deficit of $464.5 million and $372.0 million, respectively, and cash, cash equivalents and marketable securities of $266.3 million and $202.3 million, respectively. We expect to continue to incur significant expenses and 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; enrolling the detalimogene plus surfactant cohort; meeting with the FDA and planning for potential BLA initiation in the fourth quarter of calendar year 2026; and completing necessary manufacturing processes and pre-commercial activities required to support the potential approval of commercial launch of detalimogene in 2027, if approved. As a result, we expect to need additional funding to support our continuing operations and pursue our strategy.

Previous wording

We expect that our existing cash, cash equivalents and marketable securities as of April 30, 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, and neither the interim clinical data the Company reported in May 2026 and the newly announced additional cohort of LEGEND, nor the reduction in workforce announced in June 2026 have impacted this expectation.

Current wording

We expect that our existing cash, cash equivalents and marketable securities as of July 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, and neither the interim clinical data the Company reported in May 2026 and the recently announced additional cohort of LEGEND, nor the reduction in workforce announced in June 2026 have impacted this expectation.

Previous wording

On June 13, 2026, Dr. Hussein Sweiti, the Company's Chief Medical Officer and Head of Research and Development, notified the Company of his intent to resign from the Company, effective as of June 14, 2026. The Company expects to enter into an agreement with Dr. Sweiti providing for a general release and waiver of claims against the Company, after which Dr. Sweiti will be entitled to receive the severance benefits under his Amended and Restated Employment Agreement with enGene USA, Inc., effective May 6, 2026, as described in the Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission on May 7, 2026 (the "A&R Sweiti Employment Agreement"). The Company expects to incur approximately $0.7 million of personnel related costs and $1.2 million in non-cash stock-based compensation expense, primarily associated with accelerated vesting of stock options, related to Dr. Sweiti's resignation under the A&R Sweiti Employment Agreement. Effective June 15, 2026, Dr. William Grossman has been appointed as Interim Chief Medical Officer of the Company.

Current wording

On June 13, 2026, Dr. Hussein Sweiti, the Company's Chief Medical Officer and Head of Research and Development, notified the Company of his intent to resign from the Company, effective as of June 14, 2026. The Company has entered into an agreement with Dr. Sweiti providing for a general release and waiver of claims against the Company. As a result, Dr. Sweiti is entitled to receive the severance benefits under his Amended and Restated Employment Agreement with enGene USA, Inc., effective May 6, 2026, as described in the Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission on May 7, 2026 (the "A&R Sweiti Employment Agreement"). The Company has incurred $0.7 million of personnel related costs and $1.2 million in non-cash stock-based compensation expense, primarily associated with accelerated vesting of stock options, related to Dr. Sweiti's resignation under the A&R Sweiti Employment Agreement. Effective June 15, 2026, Dr. William Grossman, a member of the board of directors of the Company, has been appointed as Interim Chief Medical Officer of the Company.

Previous wording

personnel-related expenses including, salaries, benefits, share-based compensation, and other related costs for individuals involved in research and development activities; and

Current wording

personnel-related expenses including, salaries, benefits, share-based compensation, termination benefits, and other related costs for individuals involved in research and development activities; and

Previous wording

Research and development activities are central to our business model. Currently, the Company’s sole laboratory facility is located in Montreal, Quebec, Canada, and as such, a portion of the Company’s research and development and other operating expenses are incurred in Canada and denominated in the Canadian dollar. We expect that our research and development expenses will continue to increase for the foreseeable future as we progress our ongoing Phase 1/2 clinical trial for detalimogene, continue to discover and develop additional product candidates, expand our headcount and maintain, expand and enforce our intellectual property portfolio. If detalimogene or any future product candidates enter into later stages of clinical development, they will generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. There are numerous factors associated with the successful development and commercialization of any product candidates we may develop in the future, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. Additionally, future commercial and regulatory factors beyond our control will impact our clinical development program and plans.

Current wording

Research and development activities are central to our business model. Currently, the Company’s sole laboratory facility is located in Montreal, Quebec, Canada, and as such, a portion of the Company’s research and development and other operating expenses are incurred in Canada and denominated in the Canadian dollar. We expect that our research and development expenses will vary from period to period, and may increase or decrease, depending on the timing and progress of our ongoing Phase 1/2 clinical trial for detalimogene, including enrollment rates and the pace of clinical activities, our decisions regarding the discovery and development of additional product candidates and other strategic prioritization, and our efforts to maintain, expand and enforce our intellectual property portfolio. Our operating plans and related spending levels are also expected to reflect our streamlined operations following our recent restructuring and workforce reduction implemented to preserve cash. If detalimogene or any future product candidates enter into later stages of clinical development, they will generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. There are numerous factors associated with the successful development and commercialization of any product candidates we may develop in the future, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. Additionally, future commercial and regulatory factors beyond our control will impact our clinical development program and plans.

Previous wording

General and administrative expenses consist primarily of personnel-related expenses, including salaries, benefits, and share-based compensation expenses for personnel in executive and other administrative functions. Other significant general and administrative expenses include professional services, including legal, accounting and audit services, and other consulting fees, as well as facility costs not otherwise included in research and development expenses, insurance, and other operating costs.

Current wording

General and administrative expenses consist primarily of personnel-related expenses, including salaries, benefits, termination benefits, and share-based compensation expenses for personnel in executive and other administrative functions. Other significant general and administrative expenses include professional services, including legal, accounting and audit services, and other consulting fees, as well as facility costs not otherwise included in research and development expenses, insurance, and other operating costs.

Previous wording

a $1.3 million increase in personnel-related expenses, including a $0.8 million increase in stock-based compensation, driven by the hiring of key general and administrative personnel and increased bonus and contractor expenses; and

Current wording

a $3.7 million increase in personnel-related costs, including a $1.3 million increase in stock-based compensation, driven by costs related to the workforce reduction announced in June 2026; and

Previous wording

a $0.5 million decrease in other research and development, primarily driven by decreased consulting services.

Current wording

a $0.9 million increase in other research and development, primarily driven by increased medical affairs activities.

Previous wording

Research and development expenses increased by$2.0 million from$20.2 million for thethree months ended April 30, 2025 to$22.2 million for thethree months ended April 30, 2026. This increase was attributable to the following:

Current wording

Research and development expenses increased by $1.8 million from $62.8 million for the nine months ended July 31, 2025 to $64.5 million for the nine months ended July 31, 2026. This increase was attributable to the following:

Previous wording

a $2.7 million increase in personnel-related costs, including a $0.7 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

Current wording

a $8.4 million increase in personnel-related costs, including a $2.4 million increase in stock-based compensation, driven by costs related to the workforce reduction announced in June 2026 and, for a portion of the year, increased headcount and contractor expense as the Company was scaling development functions to support our LEGEND study of detalimogene; partially offset by

Previous wording

a $1.2 million decrease in detalimogene manufacturing activities driven by timing of process validation activities as the Company prepares to execute on its plans to initiate the submission of a BLA in the second half of 2026.

Current wording

a $7.7 million decrease in detalimogene manufacturing activities driven by timing of process validation activities as the Company prepares to execute on its plans to initiate the submission of a BLA in the fourth quarter of calendar year 2026.

Previous wording

General and administrative expenses increased by$2.9 million from$6.9 million for thethree months ended April 30, 2025 to$9.8 million for thethree months ended April 30, 2026. This increase was primarily attributable to the following:

Current wording

General and administrative expenses increased by $6.6 million from $7.4 million for the three months ended July 31, 2025 to $13.9 million for the three months ended July 31, 2026. This increase was primarily attributable to the following:

Previous wording

General and administrative expenses increased by$5.1 million from$13.6 million for thesix months ended April 30, 2025 to$18.7 million for thesix months ended April 30, 2026. This increase was primarily attributable to the following:

Current wording

General and administrative expenses increased by $11.7 million from $20.9 million for the nine months ended July 31, 2025 to $32.6 million for the nine months ended July 31, 2026. This increase was primarily attributable to the following:

Previous wording

a $1.6 million increase in other general and administrative expense, driven by increased facilities costs.

Current wording

a $2.6 million increase in other general and administrative expense, driven by increased market research costs.

Previous wording

Other income increased by approximately $0.2 million from income of $1.5 million for thethree months ended April 30, 2025 to income of $1.7 million for thethree months ended April 30, 2026, primarily due to an increase in interest income earned in the current period.

Current wording

Other income increased by approximately $0.3 million from income of $1.2 million for the three months ended July 31, 2025 to income of $1.5 million for the three months ended July 31, 2026, primarily due to increased interest income and decreased realized foreign exchange losses.

Previous wording

Other income decreased by approximately $0.4 million from income of $3.6 million for thesix months ended April 30, 2025 to income of $3.2 million for thesix months ended April 30, 2026, primarily due to the loss on extinguishment of debt.

Current wording

Other income decreased by approximately $0.1 million from income of $4.8 million for the nine months ended July 31, 2025 to income of $4.7 million for the nine months ended July 31, 2026, primarily due to the 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, 2026, we had cash, cash equivalents and marketable securities of approximately

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, 2026, we had cash, cash equivalents and marketable securities of approximately $266.3 million, and we had an accumulated deficit of $464.5 million. To date, the Company has not generated any revenues and has financed its liquidity needs primarily through public and PIPE financings, offering debt, and issuance of warrants.

Previous wording

our efforts to add operational, financial and management information systems, enhance existing operational, financial and management information systems and hire additional personnel, including personnel to support development of our product candidates, commercial launch preparation and commercialization efforts and our other operations as a public company,

Current wording

our efforts to add operational, financial and management information systems, enhance existing operational, financial and management information systems and hire or retain qualified personnel, including personnel to support development of our product candidates, commercial launch preparation and commercialization efforts and our other operations as a public company,

Previous wording

Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings or other capital sources, which could include collaborations, strategic alliances or licensing arrangements. Adequate additional financing, if available, may not be available to us on acceptable terms, or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our existing shareholders may be diluted, and the terms of these securities may include liquidation or other preferences that could adversely affect the rights of such shareholders. Debt financing, if available, may involve agreements that include restrictive covenants that limit our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, that could adversely impact our ability to conduct our business. If we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research program or product candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. Our ability to raise additional funds may be adversely impacted bythe price of our Common Shares, our ability to maintain the listing of our Common Shares and Warrants on the Nasdaq or another national securities exchange, potential worsening global economic conditions and disruptions to and volatilityin the credit and financial markets in the United States and worldwide. Because of the numerous risks and uncertainties associated with product development, there is no assurance that we will ever be profitable or generate positive cash flow from operating activities.

Current wording

Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings or other capital sources, which could include collaborations, strategic alliances or licensing arrangements. Adequate additional financing, if available, may not be available to us on acceptable terms, or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our existing shareholders may be diluted, and the terms of these securities may include liquidation or other preferences that could adversely affect the rights of such shareholders. Debt financing, if available, may involve agreements that include restrictive covenants that limit our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, that could adversely impact our ability to conduct our business. If we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research program or product candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. Our ability to raise additional funds may be adversely impacted by the price of our Common Shares, our ability to maintain the listing of our Common Shares and Warrants on the Nasdaq or another national securities exchange, potential worsening global economic conditions and disruptions to and volatilityin the credit and financial markets in the United States and worldwide. Because of the numerous risks and uncertainties associated with product development, there is no assurance that we will ever be profitable or generate positive cash flow from operating activities.

Previous wording

Net cash used in operating activities for thesix months ended April 30, 2026 was $59.4 million and was primarily due to our net loss of$60.0 million, partially offset by adjustments for non-cash charges totaling $7.7 million. Further changes were driven by a $7.1 million increase in net working capital adjustments.

Current wording

Net cash used in operating activities for the nine months ended July 31, 2026 was $78.3 million and was primarily due to our net loss of $92.5 million, partially offset by adjustments for non-cash charges totaling $15.9 million. Further changes were driven by a $1.7 million increase in net working capital adjustments.

Previous wording

Net cash used in operating activities for thesix 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 $0.3 million increase in net working capital adjustments.

Previous wording

Net cash used in investing activities for each of thesix months ended April 30, 2026 and 2025 was $102.7 million and $67.0 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, 2026 and 2025 was $72.5 million and $65.6 million, respectively, consisting of net purchases of marketable securities and property and equipment.

Previous wording

Net cash provided by financing activities for thesix months ended April 30, 2026 was $141.7 million, resulting from net proceeds of $140.1 million related to the public offering and issuance of 12,558,823 common shares of the Company and 2,735,295 Pre-Funded Warrants to purchase common shares in November 2025, and $1.6 million of net proceeds related to the 2026 Term Loan and closing of the Second Amended Loan Agreement with Hercules in January 2026. See Note 9 and Note 8 to our condensed consolidated financial statements included elsewhere in this Quarterly Report for discussion of the public offering, and the terms and conditions of the Hercules debt facility, respectively.

Current wording

Net cash provided by financing activities for the nine months ended July 31, 2026 was $141.8 million, primarily resulting from net proceeds of $140.1 million related to the public offering and issuance of 12,558,823 common shares of the Company and 2,735,295 Pre-Funded Warrants to purchase common shares in November 2025, and $1.6 million of net proceeds related to the 2026 Term Loan and closing of the Second Amended Loan Agreement with Hercules in January 2026. See Note 9 and Note 8 to our condensed consolidated financial statements included elsewhere in this Quarterly Report for discussion of the public offering, and the terms and conditions of the Hercules debt facility, respectively.

Previous wording

Net cash provided by financing activities for thesix months ended April 30, 2025 was $0.2 million.

Current wording

Net cash provided by financing activities for the nine months ended July 31, 2025 was $0.2 million.

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 thethree and six months ended April 30, 2026 and 2025, the Company incurred $13 and $25 thousand in expenses related to the annual maintenance fee under the terms of agreement, respectively. As of April 30, 2026 the Company had not incurred fees related to the manufacturing payment under the License Agreement.

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, 2026 and 2025, the Company incurred $13 and $38 thousand in expenses related to the annual maintenance fee under the terms of agreement, respectively. As of July 31, 2026 the Company had not incurred fees related to the manufacturing payment under the License Agreement.

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. Refer to Note 13 to our condensed consolidated financial statements included elsewhere in this Quarterly Report for expenses related to the lease obligations in thethree and six months ended April 30, 2026, 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. 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, 2026, and the future payment requirements under the lease agreements.

Previous wording

As of June 9, 2026, we had 66,989,466 Common Shares issued and outstanding, restricted share units of 266,025 Common Shares, outstanding public warrants to purchase an additional 8,449,555 Common Shares, outstanding warrants issuedto Hercules as part of our debt facilityto 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 12,015,933 Common Shares.

Current wording

As of September 2, 2026, we had 67,016,316 Common Shares issued and outstanding, restricted share units of 366,400 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 12,543,413 Common Shares.
Rearranged current paragraphs (1)

Current report — wording carried from elsewhere

a $6.5 million decrease in detalimogene manufacturing activities driven by timing of process validation activities as the Company prepares to execute on its plans to initiate the submission of a BLA in the fourth quarter of calendar year 2026; partially offset by