Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 160

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 160
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 impaired, which would have an adverse effect on its business, financial condition,
results of operations and growth prospects.

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Because Tvardi relies on third-party manufacturing and supply vendors, including single-source vendors and vendors in foreign jurisdictions, its supply of research and development, preclinical and clinical development materials may become limited or interrupted or may not be of satisfactory quantity or quality.

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Tvardi relies on third-party contract manufacturers
to manufacture its product candidates for preclinical studies and clinical trials. Tvardi does not own manufacturing facilities for producing
any clinical trial product supplies. There can be no assurance that its preclinical and clinical development product supplies will not
be limited, interrupted or of satisfactory quality or continue to be available at acceptable prices, including due to challenging macroeconomic
conditions. Because Tvardi is dependent on limited third-party suppliers and manufacturers for the manufacturing of its product candidates,
so long as it remains dependent on them, the loss of any of these suppliers and manufacturers, or any difficulties encountered by these
suppliers and manufacturers in the production of its product candidates, could materially delay the conduct of its clinical trials and
adversely impact its business.

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In addition, Tvardi relies on vendors in foreign
jurisdictions for its clinical drug supply for TTI-101, TTI-109 and future drug formulations. If this supply is interrupted for business
or geopolitical reasons, the development of TTI-101 or TTI-109 could be materially delayed. In particular, any replacement of Tvardi’s
manufacturers could require significant time, effort and expertise because there may be a limited number of qualified replacements and
the process to transfer technology and initiate manufacturing is complex and time consuming. Moreover, there is currently significant
uncertainty about the future relationship between the United States and various other countries, including China, with respect to trade
policies, treaties, government regulations and tariffs. It is possible further tariffs may be imposed that could affect imports of APIs
used in Tvardi’s product candidates or any other potential future product candidates, or its business may be adversely impacted
by retaliatory trade measures taken by China or other countries, including restricted access to such raw materials used in its current
or any other potential future product candidates.

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Table of Contents

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The manufacturing process for a product candidate
is subject to FDA and foreign regulatory authority review. Suppliers and manufacturers must meet applicable manufacturing requirements
and undergo rigorous facility and process validation tests required by regulatory authorities in