Company: TVRD
Filing Date: 2025-10-07
Form Type: S-1/A
Source: 0001104659-25-097519
Chunk: 37

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-10-07
Form: S-1/A
Chunk 37
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 outcome, liability claims may result in:

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

| ● | decreased demand for the Company products; |

| ● | injury to the Company’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 the Company’s capital resources; |

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

| ● | decline in the Company’s share price. |

22

The Company’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. The Company 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, the Company 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. The Company’s insurance policies may also have various exclusions, and the Company may be subject to a product liability claim for which it has no coverage. The Company 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 the Company may not have, or be able to obtain, sufficient capital to pay such amounts. Even if the Company’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, Healthcare Regulations and Ongoing Regulatory Compliance

The regulatory approval process is highly uncertain, and the Company may be unable to obtain, or may be delayed in obtaining, U.S. or foreign regulatory approval and, as a result, unable to commercialize TTI-101, TTI-109 or any current or future product candidates. Even if the Company believes its current, or planned clinical trials are successful, regulatory authorities may not agree that they provide adequate data on safety or efficacy.

TT