Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 86

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 86
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 efforts or other operations.

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Developing pharmaceutical products, including conducting
preclinical studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years to complete. Tvardi’s
operations have consumed substantial amounts of cash since inception. Tvardi expects its expenses to increase in connection with its ongoing
activities, particularly as it conducts its planned clinical trials of TTI-101, TTI-109 and any future product candidates that it may
develop, seek regulatory approvals for its product candidates and launch and commercialize any products for which it receives regulatory
approval. Tvardi also expects to incur additional costs associated with operating as a public company. Accordingly, it will need to obtain
substantial additional funding in order to maintain its continuing operations. If Tvardi is unable to raise capital when needed or on
acceptable terms, it may be forced to delay, reduce or eliminate one or more of its research and drug development programs or future commercialization
efforts.

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As of September 30, 2025, Tvardi had cash and cash
equivalents and short-term investments of approximately $21.4 million and $15.0 million, respectively, and Tvardi will require additional
capital in order to complete clinical development of any of its current programs. Tvardi’s monthly spending levels will vary based
on new and ongoing development and corporate activities. Because the length of time and activities associated with development of its
product candidates is highly uncertain, Tvardi is unable to estimate the actual funds it will require for development, marketing and commercialization
activities. Tvardi’s future funding requirements, both near and long-term, will depend on many factors, including, but not limited
to:

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| ● | the initiation, progress, timing, costs and results of preclinical studies and clinical trials for its product candidates; |

| ● | the clinical development plans Tvardi establishes for its product candidates; |

| ● | the timelines of its clinical trials and the overall costs to conduct and complete the clinical trials, including any increased costs due to disruptions caused by marketplace conditions, including the effects of health epidemics, or other geopolitical and macroeconomic conditions; |

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| ● | the cost and capital commitments required for manufacturing its product candidates at clinical and, if approved, commercial scales; |

| ● | the number and characteristics of product candidates that Tvardi develops; |

| ● | the outcome, timing and