enGene Holdings Inc

Evaluation of Disclosure Controls and Procedures

As of the end of the period covered by this Annual Report, management, under the supervision of and with the participation of our Chief Executive Officer (principal executive officer) and Chief Financial Officer (principal financial officer and principal accounting officer), carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) to determine whether such disclosure controls and procedures provide reasonable assurance that information to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC and such information is accumulated and communicated to management, including our principal executive and principal financial officers or persons performing similar functions, as appropriate to allow timely decisions regarding disclosure. Our disclosure controls and procedures were developed through a process in which our management applied its judgment in assessing the costs and benefits of such controls and procedures, which, by their nature, can provide only reasonable assurance regarding the control objectives. You should note that the design of any system of disclosure controls and procedures is based in part upon various assumptions about the likelihood of future events, and we cannot assure you that any design will succeed in achieving its stated goals under all potential future conditions, regardless of how remote.

As previously reported, in connection with our preparation and the audit of our consolidated financial statements as of and for the years ended October 31, 2023 and 2022, material weaknesses were identified, as defined under the Exchange Act, in our internal control over financial reporting, of which some continue to exist at October 31, 2024.

Based on our assessment, management concluded that, as of October 31, 2024, our disclosure controls and procedures were not effective due to the material weaknesses in internal controls over financial reporting described below.

Management’s Report on Internal Control Over Financial Reporting

Management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Rule 13a-15(f) under the Exchange Act. Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of the financial statements for external purposes in accordance with U.S. GAAP. Our management, under the supervision of and with the participation of our Chief Executive Officer and Chief Financial Officer, conducted an evaluation of our internal control over financial reporting based on the framework in Internal Control—Integrated Framework issued in 2013 by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this assessment, management concluded that, as of October 31, 2024, our internal control over financial reporting was not effective due to the unremediated material weaknesses 1, 4 and 5 described below.

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our consolidated financial statements will not be prevented or detected on a timely basis. The material weaknesses identified at October 31, 2023 and 2022 related to:

lack of formal policies, procedures and controls related to the design of internal controls over financial reporting, including risk assessment process and control activities for certain key financial reporting processes. We did not design and maintain an effective control environment commensurate with the financial reporting requirements of a public company. This resulted in our inability to consistently design and maintain formal accounting policies, procedures and controls or establish appropriate authorities and responsibilities in pursuit of our financial reporting objectives;

lack of sufficient accounting and financial reporting personnel to perform appropriate accounting analysis and review procedures;

lack of personnel with requisite knowledge and experience in the application of GAAP;

general information technology controls (“GITCs”) that were not designed appropriately. Specifically, we did not design and maintain: (i) program change management controls to ensure that program and data changes are identified, tested, authorized and implemented appropriately; (ii) user access controls to ensure appropriate segregation of duties and to adequately restrict user and privileged access to appropriate personnel; (iii) computer operations controls to ensure that processing and transfer of data, and data backups and recovery are monitored; and (iv) program development controls to ensure that new software development is tested, authorized and implemented appropriately; and

lack of appropriate segregation of duties in the preparation and review of account reconciliations and journal entries.

Based on the remediation efforts described below, material weakness 2 and 3 have been fully remediated as of October 31, 2024.

Notwithstanding these material weaknesses, management has concluded that the Company’s audited consolidated financial statements as at October 31, 2024 and 2023 present fairly, in all material respects, the financial position of the Company, and the results of its operations and its cash flows for the years then ended, in conformity with U.S. GAAP. These material weaknesses did not result in adjustments to the Company's previously released consolidated financial results. However, because the material weaknesses create a reasonable possibility that a material misstatement to our financial statements would not be prevented or detected on a timely basis, we concluded that as of October 31, 2024 the internal control over financial reporting was not effective.

This annual report does not include an attestation report of the Company’s registered public accounting firm due to the established rules of the Securities and Exchange Commission.

Remediation Efforts to Address the Material Weakness

Based on the remediation efforts described below, material weaknesses 2 and 3 noted above have been fully remediated as of October 31, 2024. Substantial progress has been made related to material weaknesses 1 and 5. Remediation efforts to date include the following:

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we hired finance and accounting personnel with adequate experience and U.S. GAAP knowledge, including Chief Financial Officer;

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we established adequate review and approval processes and procedures based on roles and responsibilities of each accounting members;

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we are implementing a risk assessment over financial reporting controls;

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we are designing and implementing policy, procedures and controls around key business and financial reporting process;

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we are implementing new software tools with adequate set up to ensure segregation of duties; and

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we have engaged a professional accounting services firm to help with the documentation and assessment of our internal controls for complying with the Sarbanes-Oxley Act;

While significant progress has been made to enhance our internal control over financial reporting, further testing is necessary before we can conclude full remediation to material weaknesses 1 and 5. We also require additional time to design appropriate GITCs (material weakness 4). Additional time is required to complete the remediation over ineffective policies, procedures and controls related to financial reporting, GITCs and segregation of duties to demonstrate the sustainability of these remediation actions.

Inherent Limitations on Effectiveness of Controls

Our management, including our Principal Executive Officer and Principal Financial Officer, concluded that, as of October 31, 2024, our disclosure controls and procedures and internal control over financial reporting were not effective at a reasonable assurance level due to the material weaknesses described above. However, our management does not expect that effective disclosure controls and procedures or our internal control over financial reporting will prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Furthermore, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate.

Changes in Internal Control Over Financial Reporting

Changes in our internal control over financial reporting during the year ended October 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting are described above. Other than the items discussed above, there were no other changes in our internal control over financial reporting during the fourth quarter ended October 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.