Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 101

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 101
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i may encounter difficulties enrolling subjects in its clinical trials due,
in part, to the small size of these patient populations. Tvardi’s clinical trials compete with other clinical trials for product
candidates that are in the same therapeutic areas as its product candidates, and this competition will reduce the number and types of
patients available to Tvardi, because some patients who might have opted to enroll in Tvardi’s clinical trials may instead opt to
enroll in a clinical trial being conducted by one of its competitors. Since the number of qualified clinical investigators is limited,
Tvardi expects to conduct some of its clinical trials at the same clinical trial sites that some of its competitors use, which will reduce
the number of patients who are available for Tvardi’s clinical trials in such clinical trial site. Certain of Tvardi’s planned
clinical trials may also involve invasive procedures such as bronchoscopy and broncho-alveolar lavage, which may lead some patients to
drop out of clinical trials to avoid these follow-up procedures.

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Additionally, the FDA may modify or enhance clinical
trial requirements, which may affect enrollment. For example, in August 2023, the FDA published a guidance document, “Informed Consent,
Guidance for IRBs, Clinical Investigators, and Sponsors,” which supersedes past guidance and finalizes draft guidance on informed
consent. The FDA’s new guidance presents evolving requirements for informed consent which may affect recruitment and retention of
patients in clinical trials. Effects on recruitment and retention of patients may hinder or delay a clinical trial and could cause a significant
setback to an applicable program.

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The design or execution of Tvardi’s ongoing and future clinical trials may not support marketing approval.

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The design or execution of a clinical trial can
determine whether its results will support marketing approval, and flaws in the design or execution of a clinical trial may not become
apparent until the clinical trial is well advanced. Tvardi is currently conducting a Phase 2 clinical trial of TTI-101 in HCC as monotherapy
and combination with SoC therapy. In some instances, there can be significant variability in safety or efficacy results between different
clinical trials with the same product candidate due to numerous factors, including differences in clinical trial protocols, size and type
of the patient populations, variable adherence to the dosing regimen or other protocol requirements and the rate of dropout among clinical
trial participants. Tvardi does not know whether any clinical trials it conducts will demonstrate consistent