Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 91

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 91
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 regulatory requirements, policy and guidelines, including the imposition of additional regulatory oversight around clinical testing generally or with respect to Tvardi’s technology in particular; or |

| ● | varying interpretations of Tvardi’s clinical and preclinical data by the FDA and other comparable foreign regulatory authorities. |

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In addition, because Tvardi’s other product
candidates, in particular TTI-109, are based on similar mechanisms of action, if TTI-101 encounters safety or efficacy problems, manufacturing
or supply interruptions, developmental delays, regulatory issues or other problems, its development plans and business related to those
other indications for TTI-101 as well as other product candidates could be significantly harmed. Tvardi does not have complete control
over many of these factors, including certain aspects of clinical development and the regulatory submission process, potential threats
to its intellectual property rights and its manufacturing, marketing, distribution and sales efforts or that of any future collaborator.

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Preclinical and clinical development involves a lengthy, complex and expensive process, with an uncertain outcome.

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To obtain the requisite regulatory approvals to
commercialize any product candidates, Tvardi must demonstrate through extensive preclinical studies and clinical trials that its product
candidates are safe and effective in humans. Clinical testing is expensive and can take many years to complete, and its outcome is inherently
uncertain. In particular, the general approach for FDA approval of a new drug is dispositive data from two well-controlled, Phase 3 clinical
trials of the relevant drug in the relevant patient population. Phase 3 clinical trials typically involve hundreds of patients, have significant
costs and take years to complete. A product candidate can fail at any stage of testing, even after observing promising signals of activity
in earlier preclinical studies or earlier stage clinical trials. There is typically an extremely high rate of attrition from the failure
of product candidates proceeding through clinical trials. Product candidates in later stages of clinical trials may fail to show the desired
safety and efficacy profile despite having progressed through preclinical studies and initial 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.
A large number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack
of efficacy or unacceptable safety issues, notwithstanding promising results in earlier clinical trials. Most product candidates that
commence clinical trials are never