Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 76

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 76
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Table of Contents

Changes in Internal Control Over Financial Reporting

There was no change in Tvardi’s internal control
over financial reporting that occurred during the quarter ended September 30, 2025 that has materially affected, or is reasonably
likely to materially affect, Tvardi’s internal control over financial reporting.

Limitations on Controls and Procedures

Management, including Tvardi’s principal executive
officer and principal financial officer, recognizes that any controls and procedures, no matter how well designed and operated, can provide
only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost benefit
relationship of possible controls and procedures. Because of the inherent limitations of the effectiveness of all control systems, no
evaluation of controls and procedures can provide absolute assurance that all control issues and instances of fraud, if any, within Tvardi
have been detected.

Material Weaknesses in Internal Control Over Financial Reporting Related to Legacy Tvardi

In connection with the preparation of Legacy Tvardi’s
financial statements for the years ended December 31, 2024 and 2023, material weaknesses were identified in the design and operating effectiveness
of Legacy Tvardi’s internal control over financial reporting. A material weakness is a deficiency, or combination of deficiencies,
in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the annual or
interim financial statements will not be prevented or detected on a timely basis.

Two of these material weaknesses are related to
the fact that Legacy Tvardi lacked a sufficient number of professionals to consistently establish appropriate authorities and responsibilities
in pursuit of Legacy Tvardi’s financial reporting objectives. The lack of sufficient number of finance and accounting professionals
contributed to the inadequate design and Legacy Tvardi’s inability to maintain effective controls over the segregation of duties
related to journal entries. In addition, Legacy Tvardi identified a material weakness in its financial reporting related to inadequate
review of financial statements and disclosures. The third material weakness pertains to the prepaid and accrued research and development
expenses related to the CRO. The lack of formal documentation and timely communication of applicable updates to these expenses contributed
to Legacy Tvardi’s inability to maintain effective controls over the CRO accrual process.

Management’s Plan to Remediate the Legacy Tvardi Material Weaknesses

To remediate the material weaknesses, Tvardi has
begun a formal risk assessment process to identify control gaps and design new procedures and