Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 94

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 94
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 may be unable to establish clinical endpoints that applicable regulatory authorities would consider
clinically meaningful, and a clinical trial can fail at any stage of testing.

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Table of Contents

Tvardi completed clinical trials of its lead product
candidate, TTI-101, in healthy volunteers and in patients with advanced malignancies, where TTI-101 was observed to be generally well-tolerated.
However, if significant adverse events or other side effects are observed in any of its ongoing or future clinical trials, Tvardi may
have difficulty recruiting patients to its clinical trials, patients may drop out of its clinical trials or it may be required to abandon
the clinical trials or development efforts altogether. For example, in Tvardi’s Phase 2 clinical trial in IPF, Tvardi observed discontinuation
rates of 56.7% in the 400 mg arm and 62.1% in the 800 mg arm, as compared to 10.3% in the placebo arm. The discontinuation rates in the
TTI-101 arms were primarily driven by gastrointestinal adverse events, with higher rates of events and discontinuations among patients
on concurrent nintedanib. In addition, in Tvardi’s ongoing Phase 2 clinical trial, Tvardi is evaluating TTI-101 administered alone
or in addition to standard of care (SoC) HCC agents. Tvardi may encounter unexpected drug-drug interactions in planned clinical trials
and may be required to further test these product candidates, including additional drug-drug interaction studies, which may be expensive
and time-consuming and result in delays to Tvardi’s programs.

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Additionally, in Tvardi’s Phase 1b/2 clinical
trial in HCC, Tvardi explored escalating dosages of TTI-101 up to 1200 mg/day and determined 800 mg/day as the recommended monotherapy
Phase 2 dose (RP2D). Based upon the HCC RP2D determination as well as other early data, Tvardi requested that the Safety Monitoring Committee
of the Phase 2 clinical trial in IPF convene to consider discontinuation of enrollment to 1200 mg/day arm. The Safety Monitoring Committee
agreed with Tvardi’s recommendation to discontinue enrollment to the 1200 mg/day arm. In addition, after reviewing the benefit-risk
of the remaining arms of the clinical trial, they recommended to continue enrollment to the 400 mg