Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 110

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 110
---
, Reimbursement, Healthcare Regulations and Ongoing Regulatory Compliance

​

The regulatory approval process is highly uncertain, and Tvardi may be unable to obtain, or may be delayed in obtaining, U.S. or foreign regulatory approval and, as a result, unable to commercialize TTI-101, TTI-109 or any current or future product candidates. Even if Tvardi believes its current, or planned clinical trials are successful, regulatory authorities may not agree that they provide adequate data on safety or efficacy.

​

TTI-101, TTI-109 and any other current or future
product candidates Tvardi develops are subject to extensive governmental regulations relating to, among other things, research, testing,
development, manufacturing, approval, recordkeeping, reporting, labeling, storage, packaging, advertising and promotion, pricing, post-approval

<div align='center'>66</div>

Table of Contents

monitoring, marketing and distribution of products. Rigorous preclinical
studies and clinical trials and an extensive regulatory approval process are required to be completed successfully in the United States
and in many foreign jurisdictions before a new product can be marketed. Satisfaction of these and other regulatory requirements is costly,
time-consuming, uncertain and subject to unanticipated delays. It is possible that none of Tvardi’s product candidates will obtain
the regulatory approvals necessary for Tvardi to begin selling them.

​

As a company, Tvardi has no prior experience in
conducting and managing the clinical trials necessary to obtain regulatory approvals, including approval by the FDA. The time required
to obtain FDA and other approvals is unpredictable but typically takes many years following the commencement of clinical trials, depending
upon the type, complexity and novelty of the product candidate. The standards that the FDA and its foreign counterparts use when regulating
Tvardi require judgment and can change, which makes it difficult to predict with certainty their application. Any analysis Tvardi performs
of data from preclinical studies and clinical trials is subject to confirmation and interpretation by regulatory authorities, which could
delay, limit or prevent regulatory approval. Tvardi may also encounter unexpected delays or increased costs due to new government regulations,
for example, from future legislation or administrative action, or from changes in FDA policy during the period of product development,
clinical trials and FDA regulatory review. It is impossible to predict whether additional legislative changes will be enacted, or whether
FDA or foreign regulations, guidance or interpretations will be changed, or the impact of such changes, if any. Any elongation or