Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 96

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 96
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Table of Contents

| ● | Tvardi, or any future collaborators, may be subject to fines, injunctions or the imposition of civil or criminal penalties; |

| ● | Tvardi, or any future collaborators, could be sued and held liable for harm caused to patients; |

| ● | the product may become less competitive; and |

| ● | Tvardi’s reputation may suffer. |

​

Any of the foregoing could prevent Tvardi from achieving
or maintaining market acceptance of the particular product candidate, if approved, and could significantly harm its business, results
of operations and prospects, and could adversely impact Tvardi’s financial condition, results of operations or the market price
of its common stock.

​

Tvardi may be subject to additional risks because it intends to evaluate its product candidates in combination with the standard of care for the indications that Tvardi is pursuing.

​

Tvardi intends to evaluate its product candidates
in combination with other compounds, specifically the standard of care for the indications that Tvardi is pursuing. The use of Tvardi’s
product candidates in combination with such other compounds may subject it to risks that Tvardi would not face if its product candidates
were being administered as monotherapy. The outcome and cost of developing a product candidate to be used with other compounds is difficult
to predict and dependent on a number of factors that are outside its control. If Tvardi experiences efficacy or safety issues in its clinical
trials in which its product candidates are being administered with other compounds, Tvardi may not receive regulatory approval for its
product candidates, which could prevent it from ever generating revenue or achieving profitability.

​

Tvardi may experience delays in initiating, completing or ultimately be unable to complete, the development and commercialization of TTI-101, TTI-109 or any other product candidates.

​

Tvardi may experience delays in initiating or completing
clinical trials. Tvardi also may experience numerous unforeseen events during, or as a result of, any future clinical trials that could
delay or prevent its ability to receive marketing approval or commercialize TTI-101, TTI-109 or any other product candidates, including:

​

| ● | regulators or institutional review boards (IRBs), or ethics committees may not authorize Tvardi and its investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; |

| ● | the FDA or other comparable regulatory authorities may disagree with Tvardi