Company: TVRD
Filing Date: 2025-01-27
Form Type: S-4/A
Source: 0001104659-25-006050
Chunk: 167

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-01-27
Form: S-4/A
Chunk 167
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, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. Claims could also be asserted under state consumer 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:

| ● | 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 continues clinical development and as additional product candidates, including TTI-109, enter the clinic. 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,

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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.

Risks Related to Marketing, Reimbursement,