Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 99

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 99
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 results as necessarily indicative of results that will be obtained in subsequent clinical trials or clinical practice.
Differences between preliminary or interim data and final data could significantly harm Tvardi’s business prospects.

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Table of Contents

Positive results from early preclinical studies and clinical trials of Tvardi’s current or future product candidates are not necessarily predictive of the results of later preclinical studies and clinical trials of Tvardi’s current or future product candidates. If Tvardi cannot replicate the positive results from preclinical studies or early clinical trials of its current or future product candidates in future clinical trials, Tvardi may be unable to successfully develop, obtain regulatory approval for and commercialize current or future product candidates.

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Positive results from Tvardi’s preclinical
studies of current or future product candidates, and any positive results it may obtain from early clinical trials of its current or future
product candidates, including the ongoing and future clinical trials of TTI-101, may not necessarily be predictive of the results from
required later preclinical studies and clinical trials. Similarly, even if Tvardi is able to complete its planned preclinical studies
or clinical trials of current or future product candidates according to its current development timeline, the positive results from such
preclinical studies and/or clinical trials of current or future product candidates, including TTI-101 and TTI-109, may not be replicated
in subsequent preclinical studies or clinical trials. In particular, while Tvardi has conducted certain preclinical studies of TTI-109
and Phase 1 clinical trials of TTI-101, it does not know whether either of these product candidates will perform in planned clinical trials
as it has performed in these prior preclinical studies or early clinical trials. For example, Tvardi reported preliminary data from its
Phase 2 clinical trial of TTI-101 in IPF in October 2025 and concluded that the study did not meet its goals.

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There is no guarantee that preclinical results or
early clinical results will be replicated in later clinical trials. Many companies in the pharmaceutical and biotechnology industries
have suffered significant setbacks in late-stage clinical trials after achieving positive results in early-stage development, and Tvardi
cannot be certain that it will not face similar setbacks. These setbacks have been caused by, among other things, preclinical findings
made while clinical trials were underway or safety or efficacy observations made in preclinical studies and clinical trials, including
previously unreported adverse