Company: TVRD
Filing Date: 2025-05-30
Form Type: S-1
Source: 0001104659-25-054853
Chunk: 26

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-05-30
Form: S-1
Chunk 26
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 or distribution; |

| ● | the Company, or any future collaborators, may be required to recall the product, change the way such product is administered to patients or conduct additional clinical trials; |

| ● | additional restrictions may be imposed on the marketing of, or the manufacturing processes for, the particular product; |

| ● | regulatory authorities may require additional warnings on the label, such as a “black box” warning or a contraindication, or impose distribution or use restrictions; |

| ● | the Company, or any future collaborators, may be required to create a Risk Evaluation and Mitigation Strategy (“REMS”), which could include a medication guide outlining the risks of such side effects for distribution to patients, a communication plan for healthcare providers and/or other elements to assure safe use; |

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

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

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

| ● | the Company’s reputation may suffer. |

Any of the foregoing could prevent the Company 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 the Company’s financial condition, results of operations or the market price of its common stock. The Company 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 the Company is pursuing. The Company intends to evaluate its product candidates in combination with other compounds, specifically the standard of care for the indications that the Company is pursuing. The use of the Company’s product candidates in combination with such other compounds may subject it to risks that the Company 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 the Company experiences efficacy or safety issues in its clinical trials in which its product candidates are being administered with other compounds, the Company may not receive regulatory approval for its product candidates, which could prevent it from ever generating revenue or achieving profitability. The Company 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. The Company may experience delays