Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 88

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 88
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 to develop or commercialize
alone. Market volatility resulting from challenging financial markets factors, including the effects of health epidemics and geopolitical
conflicts or other factors, could also adversely impact Tvardi’s ability to access capital when and in the amounts needed. If Tvardi
is unable to raise additional capital in sufficient amounts or on terms acceptable to it, it may have to significantly delay, scale back
or discontinue the development or commercialization of one or more of its product candidates or one or more of its other research and
development initiatives. Any of the above events could significantly harm its business, prospects, financial condition and results of
operations and cause the price of its common stock to decline.

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Table of Contents

The amount of Tvardi’s future losses is uncertain, and its quarterly and annual operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause its stock price to fluctuate or decline.

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Tvardi’s quarterly and annual operating results
may fluctuate significantly in the future due to a variety of factors, many of which are outside of its control and may be difficult to
predict, including the following:

​

| ● | the timing and success or failure of clinical trials for its product candidates or competing product candidates; |

| ● | Tvardi’s ability to successfully recruit and retain subjects for clinical trials, and any delays caused by difficulties in such efforts; |

| ● | Tvardi’s ability to obtain marketing approval for its product candidates, and the timing and scope of any such approvals it may receive; |

| ● | the timing and cost of, and level of investment in, research and development activities relating to its product candidates, which may change from time to time; |

| ● | the cost of manufacturing its product candidates, which may vary depending on the difficulty of manufacturing, quantity of production and the terms of its agreements with manufacturers; |

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| ● | Tvardi’s ability to attract, hire and retain qualified personnel; |

| ● | expenditures that Tvardi will or may incur to develop additional product candidates; |

| ● | the level of demand for its product candidates should they receive approval, which may vary significantly; |

| ● | the risk/benefit profile, cost and reimbursement policies with respect to its product candidates, if approved; |

| ● | existing and potential future therapeutics that compete with its product candidates; |

| ● | changes in the competitive landscape of