Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 89

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 89
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 Tvardi’s industry, including consolidation among competitors or partners; |

| ● | general market conditions or extraordinary external events, such as recessions or the effects of health epidemics; |

| ● | the changing and volatile U.S. and global economic and political environments; and |

| ● | future accounting pronouncements or changes in its accounting policies. |

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The cumulative effects of these factors could result
in large fluctuations and unpredictability in Tvardi’s quarterly and annual operating results. As a result, comparing Tvardi’s
operating results on a period-to-period basis may not be meaningful. This variability and unpredictability could also result in it failing
to meet the expectations of industry or financial analysts or investors for any period. If Tvardi’s revenue or operating results
fall below the expectations of analysts or investors or below any forecasts Tvardi may provide to the market, or if the forecasts Tvardi
provides to the market are below the expectations of analysts or investors, the price of its common stock could decline substantially.
Such a stock price decline could occur even when Tvardi has met any previously publicly stated guidance it may provide.

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Table of Contents

Risks Related to Research and Development and the Biopharmaceutical Industry

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Tvardi’s business is highly dependent on the success of its product candidates, TTI-101, TTI-109 and any other product candidates that it advances into the clinic. All of Tvardi’s product candidates will require significant additional preclinical and clinical development before Tvardi may be able to seek regulatory approval for and launch a product commercially.

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Tvardi is currently conducting a Phase 2 clinical
trial of TTI-101 in HCC, has no products that are approved for commercial sale and may never be able to develop marketable products. Tvardi
is early in its development efforts and has only two product candidates, TTI-101 and TTI-109, in early clinical development. If TTI-101,
TTI-109 or any of its other product candidates encounter safety or efficacy problems, development delays, regulatory issues or other problems,
Tvardi’s development plans and business would be significantly harmed. 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, and Tvardi is conducting additional
analyses to further understand these