Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 93

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 93
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 which could make it subject to additional regulatory requirements. Any analysis Tvardi
performs of data from preclinical and clinical activities 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. Examples of such regulations include future legislation or administrative action, or changes in FDA policy during the period
of product development and FDA regulatory review. It is impossible to predict whether legislative changes will be enacted, or whether
FDA or foreign regulations, guidance or interpretations will be changed, or what the impact of such changes, if any, may be. The FDA may
also require a panel of experts, referred to as an Advisory Committee, to deliberate on the adequacy of the safety and efficacy data to
support approval. The opinion of the Advisory Committee, although not binding, may have a significant impact on Tvardi’s ability
to obtain approval of any product candidates that it develops.

​

Successful completion of clinical trials is a prerequisite
to submitting a new drug application (NDA), to the FDA and similar marketing applications to comparable foreign regulatory authorities,
for each product candidate, and, consequently, the ultimate approval and commercial marketing of any product candidates. Tvardi may experience
negative or inconclusive results, which may result in it deciding, or being required by regulators, to conduct additional preclinical
studies or clinical trials or abandon some or all of its product development programs, which could have a material adverse effect on its
business.

​

Tvardi’s ongoing and future clinical trials may reveal significant adverse events or unexpected drug-drug interactions not seen in preclinical studies and may result in a safety profile that could delay or prevent regulatory approval or market acceptance of any of its product candidates.

​

To obtain the requisite regulatory approvals to
market and sell TTI-101 or TTI-109 for any indication, or any of Tvardi’s future product candidates, it must demonstrate through
clinical trials that such product candidates are safe and effective for use in each targeted indication. Most product candidates that
begin clinical trials are never approved by regulatory authorities for commercialization. Unforeseen side effects could arise either during
clinical development, or, if such side effects are more rare, after Tvardi’s products have been approved by regulatory authorities
and the approved product has been marketed, resulting in the exposure of additional patients than if such side effect had arisen during
a clinical trial. Further, Tvardi