Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 64

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 64
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 on Tvardi’s financial condition and on its ability to pursue its business plans and strategies. If Tvardi
is unable to raise capital, it will need to delay, reduce or terminate planned activities to reduce costs.

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Table of Contents

Because of the numerous risks and uncertainties
associated with research, development and commercialization of pharmaceutical products, Tvardi is unable to estimate the exact amount
of its operating capital requirements.

Tvardi’s future funding requirements will
depend on many factors, including, but not limited to:

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

| ● | 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 cost of meeting regulatory requirements established by the FDA and other comparable foreign regulatory authorities; |

| ● | whether Tvardi is able to enter into future collaboration agreements and the terms of any such agreements; |

| ● | the ability to achieve and timing of achieving a favorable pricing and reimbursement decision by the pricing authorities in the markets of interest; |

| ● | the cost of filing, prosecuting, defending and enforcing its patent claims and other intellectual property rights, including patent infringement actions brought by third parties against Tvardi or its product candidates; |

| ● | the effect of competing technological and market developments; |

| ● | the cost and timing of completion of commercial-scale outsourced manufacturing activities; and |

| ● | the cost of establishing sales, marketing and distribution capabilities for any product candidates for which Tvardi may receive regulatory approval in regions where it chooses to commercialize its products on its own. |

A change in the outcome of any of these or other
variables with respect to the development of any of Tvardi’s current and future product candidates could significantly change the
costs and timing associated with the development of that product candidate. See the section titled “Risk Factors” set forth
in this Quarterly Report for additional risks associated with T