Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 158

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 158
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 inspections of clinical trial sponsors, clinical investigators and clinical trial sites.
If Tvardi or any of these third parties fail to comply with applicable GCP requirements, the clinical data generated in its clinical trials
may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require Tvardi to suspend or terminate these clinical
trials or perform additional preclinical studies or clinical trials before approving its marketing applications. Tvardi cannot be certain
that, upon inspection, such regulatory authorities will determine that any of its clinical trials comply with the GCP requirements.

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Tvardi’s failure or any failure by these third
parties to comply with these regulations or to recruit a sufficient number of patients may require Tvardi to repeat clinical trials, which
would delay the regulatory approval process. Moreover, Tvardi’s business may be implicated if any of these third parties violates
federal or state fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.

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Any third parties conducting aspects of Tvardi’s
preclinical studies or clinical trials will not be its employees and, except for remedies that may be available to Tvardi under its agreements
with such third parties, it cannot control whether or not they devote sufficient time and resources to its preclinical studies and clinical
programs. These third parties may also have relationships with other commercial entities, including Tvardi’s competitors, for whom
they may also be conducting clinical trials or other product development activities, which could affect their performance on its behalf.
If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need
to be replaced or if the quality or accuracy of the preclinical or clinical data they obtain is compromised due to the failure to adhere
to Tvardi’s protocols or regulatory requirements or for other reasons or if due to federal or state orders or absenteeism due to
global conditions, including health epidemics and pandemics, they are unable to meet their contractual and regulatory obligations, Tvardi’s
development timelines, including clinical development timelines, may be extended, delayed or terminated and Tvardi may not be able to
complete development of, obtain regulatory approval of or successfully commercialize its product candidates. As a result, Tvardi’s
financial results and the commercial prospects for its product candidates would be harmed, its costs could increase and its ability to
generate revenue could be delayed.

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If any of Tvardi’s relationships with these
third-party CROs or others terminate,