Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 109

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 109
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, negligence,
strict liability or a breach of warranties. Claims could also be asserted under state consumer

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protection acts. If Tvardi cannot successfully defend itself against
product liability claims, it may incur substantial liabilities or be required to limit commercialization of its product candidates. Even
successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability
claims may result in:

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| ● | inability to bring a product candidate to the market; |

| ● | decreased demand for Tvardi products; |

| ● | injury to Tvardi’s reputation; |

| ● | withdrawal of clinical trial participants and inability to continue clinical trials; |

| ● | initiation of investigations by regulators; |

| ● | fines, injunctions or criminal penalties; |

| ● | costs to defend the related litigation; |

| ● | diversion of management’s time and its resources; |

| ● | substantial monetary awards to trial participants; |

| ● | product recalls, withdrawals or labeling, marketing or promotional restrictions; |

| ● | loss of revenue; |

| ● | exhaustion of any available insurance and Tvardi’s capital resources; |

| ● | the inability to commercialize any product candidate, if approved; and |

| ● | decline in Tvardi’s share price. |

​

Tvardi’s inability to obtain sufficient product
liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization
of products it develops. Tvardi will need to obtain additional insurance for clinical trials as TTI-101 and TTI-109 continue clinical
development. However, Tvardi may be unable to obtain, or may obtain on unfavorable terms, clinical trial insurance in amounts adequate
to cover any liabilities from any of its clinical trials. Tvardi’s insurance policies may also have various exclusions, and Tvardi
may be subject to a product liability claim for which it has no coverage. Tvardi may have to pay any amounts awarded by a court or negotiated
in a settlement that exceed its coverage limitations or that are not covered by its insurance, and Tvardi may not have, or be able to
obtain, sufficient capital to pay such amounts. Even if Tvardi’s agreements with any future corporate collaborators entitle it to
indemnification against losses, such indemnification may not be available or adequate should any claim arise.

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Risks Related to Marketing