Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 77

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 77
---
 controls to remediate the identified weaknesses.
Tvardi has added additional experienced accounting and financial reporting personnel and resources and is formalizing the design and implementation
of internal controls over the financial reporting process. The material weaknesses will not be considered remediated until management
completes the design and implementation of the measures described above and the controls operate for a sufficient period of time and management
has concluded, through testing, that these controls are effective. The measures Tvardi has taken to date, and is continuing to design
and implement, may not be sufficient to remediate the material weaknesses Legacy Tvardi identified or avoid potential future material
weaknesses. If the steps Tvardi takes do not correct these material weaknesses in a timely manner, Tvardi will be unable to conclude that
it maintains effective internal control over financial reporting. Accordingly, there could continue to be a reasonable possibility that
a material misstatement of Tvardi’s financial statements would not be prevented or detected on a timely basis.

During the remainder of fiscal year 2025, management
will test and evaluate the related internal controls to ascertain whether they are designed and operating effectively to provide reasonable
assurance that they will prevent or detect a material error in the financial statements.

​

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<div align='center'>45</div>

Table of Contents

<div align='center'>PART II — OTHER INFORMATION</div>

Item 1. Legal Proceedings

Merger Proceedings

Between December 20, 2024, and March 19, 2025, Cara
received 13 demands (and three draft complaints) from purported stockholders of Cara (collectively, the Demands) challenging the disclosures
in the proxy statement/prospectus (the Proxy Statement/Prospectus) included in the Registration Statement on Form S-4 related to the Merger
and asserting claims for violations of Sections 14(a) and 20(a) of the Securities Exchange Act of 1934. In addition, on March 5 and March
6, 2025, two lawsuits were filed by purported stockholders of Cara in the Supreme Court of the State of New York, County of New York.
The lawsuits are captioned Joseph Clark v. Cara Therapeutics, Inc., et al., No. 651260/2025 and Michael Kent v. Cara Therapeutics, Inc.,
et al., No. 651272/2025 (collectively, the Complaints). The Complaints named Cara and the members of the Cara board of directors as defendants