Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 159

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 159
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 Tvardi may not be able to enter into arrangements with alternative CROs or other third parties or
to do so on commercially reasonable terms.

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Table of Contents

Switching or adding additional CROs involves additional
cost and requires management time and focus. In addition, there is a natural transition period when a new CRO begins work. As a result,
delays may occur, which can materially impact Tvardi’s ability to meet its desired development timelines. Though Tvardi carefully
manages its relationships with its CROs, there can be no assurance that it will not encounter similar challenges or delays in the future
or that these delays or challenges will not have a material adverse impact on its business, financial condition and prospects.

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Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.

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As product candidates progress through preclinical
to late-stage clinical trials to marketing approval and commercialization, it is common that various aspects of the development program,
such as manufacturing methods and formulation, are altered along the way in an effort to optimize yield, manufacturing batch size, minimize
costs and achieve consistent quality and results. Such changes carry the risk that they will not achieve these intended objectives. Any
of these changes could cause Tvardi’s product candidates to perform differently and affect the results of planned clinical trials
or other future clinical trials conducted with the altered materials. This could delay completion of clinical trials, require the conduct
of bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of Tvardi’s
product candidates and jeopardize Tvardi’s ability to commercialize its product candidates and generate revenue.

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In addition, there are risks associated with large
scale manufacturing for clinical trials or commercial scale including, among others, cost overruns, potential problems with process scale-up,
process reproducibility, stability issues, compliance with good manufacturing practices, lot consistency and timely availability of raw
materials. Even if Tvardi obtains marketing approval for any of its product candidates, there is no assurance that its manufacturers will
be able to manufacture the approved product to specifications acceptable to the FDA or other comparable foreign regulatory authorities,
to produce it in sufficient quantities to meet the requirements for the potential commercial launch of the product or to meet potential
future demand. If Tvardi’s manufacturers are unable to produce sufficient quantities for clinical trials or for commercialization,
its development and commercialization efforts would be