Cartesian Therapeutics Inc

Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures, as defined in Exchange Act Rules 13a-15(e) and 15d-15(e), that are designed to ensure information required to be disclosed by us in reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to our management, including our principal executive officer and principle financial officer, to allow timely decisions regarding required disclosure. 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 achieved. Further, the design of a control system must be balanced against resource constraints, and therefore, the benefits of controls must be considered relative to their costs. Given the inherent limitations in all systems of controls, no evaluation of controls can provide absolute assurance all control issues and instances of fraud, if any, within a company 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 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 the policies and procedures may deteriorate. Accordingly, given the inherent limitations in a cost-effective system of controls, financial statement misstatements due to error or fraud may occur and may not be detected. Our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance of achieving their objectives. We conduct periodic evaluations of our system of controls to enhance, where necessary, our control policies and procedures.

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this Annual Report on Form 10-K. Based upon this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of December 31, 2024.

Remediation of Previously Identified Material Weakness

We previously reported a material weakness, identified in 2023, in our internal controls specifically related to the documentation of the assumptions supporting the valuation of the in-process research and development intangible assets acquired in connection with the Old Cartesian material business combination and the initial and on-going contingent value right obligation issued at that time to legacy Selecta stockholders. This material weakness included a lack of sufficient documentation to provide evidence of the associated management review controls.

Although we have not entered into any business combination transactions since November 2023, the annual impairment testing required for our in-process research and development intangible assets necessitates similar valuation processes and controls. For example, both could require the development of sophisticated long-range cash flow forecasts, by indication and market, appropriately adjusted for probability of success, which include but are not limited to: (i) revenues from product sales and/or royalties; (ii) expenses, including costs of goods sold, research and development, general and administrative and sales and marketing; (iii) expectations of long-term effective tax rates; (iv) consideration of capital expenditures which may be required in order to achieve revenue; and (v) working capital requirements. The resulting forecasts are then subjected to a discounted cash flow analysis in order to arrive at an estimate of fair value. A similar cash flow forecasting process and discounted cash flow analysis is utilized at each reporting period to determine the estimated fair value of the contingent value right obligation.

For the Company’s required annual impairment testing (performed as of October 1, 2024) of its in-process research and development intangible assets, management documented and reviewed the significant inputs and assumptions used in the purchase accounting for the Old Cartesian material business combination. As proscribed in “ASC 350 – Intangibles – Goodwill and Other,” management began with a qualitative assessment to determine whether it was necessary to perform the quantitative testing. Management’s qualitative assessment resulted in a determination that it was not more likely than not that the Company’s in-process research and development assets were impaired. Therefore, quantitative testing was not required to be performed.

At each reporting period during fiscal 2024, management documented and reviewed the significant inputs and assumptions used by the Company’s third-party valuation firm to determine the estimated fair value of the contingent value right obligation. Cash flow forecasts were prepared by management, along with the necessary documentation and memoranda evidencing that the required controls were in place and operating effectively. These cash flow forecasts were then subjected to discounted cash flow analysis to determine the estimated fair value of the contingent value right obligation.

Based upon management’s assessment, we have concluded that our disclosure controls and procedures were designed and operating effectively as of December 31, 2024 and, therefore, the previously identified material weakness was remediated.

Management’s Annual Report on Internal Control over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Exchange Act Rules 13a-15(f) and 15d-15(f), to provide reasonable assurance regarding the reliability of our financial reporting and the preparation of financial statements for external purposes in accordance with U.S. GAAP. Internal control over financial reporting includes our policies and procedures, such as our Code of Business Conduct and Ethics, which (i) require our employees, officers and directors to adhere to certain ethical standards; (ii) require the maintenance of records, in reasonable detail, to help to ensure that our transactions, assets and liabilities are accurately and fairly recorded; (iii) provide reasonable assurance that transactions are authorized by our management and directors and are recorded as necessary to allow for the accurate preparation of financial statements in accordance with U.S. GAAP; and (iv) provide reasonable assurance regarding the safeguarding of our assets and the prevention or timely detection of the unauthorized acquisition, use or disposition of our assets, which could have a material effect on the financial statements. Internal control over financial reporting includes the controls themselves, management’s monitoring of those controls, actions taken to correct any deficiencies identified and oversight of our internal control environment by the Audit Committee of our Board of Directors. Any system of internal control has inherent limitations and therefore may not prevent or detect misstatements. Projections of any evaluation of the effectiveness of internal control over financial reporting to future periods are subject to the risk that controls may become inadequate over time because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Our management assessed the effectiveness of our internal control over financial reporting as of the end of our fiscal year 2024 and has reviewed the results of this assessment with the Audit Committee of our Board of Directors. Management based its assessment on criteria established in “Internal Control - Integrated Framework (2013)” issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based upon this assessment, our management concluded that our internal control over financial reporting was effective as of December 31, 2024.

Changes in Internal Control over Financial Reporting

Except as described above under “—Remediation of Previously Identified Material Weakness,” there have been no changes in our internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) during the fiscal quarter ended December 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Attestation Report of the Registered Public Accounting Firm

This Annual Report on Form 10-K does not include an attestation report of our registered public accounting firm due to an exemption established for “smaller reporting companies.”