Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 165

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 165
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 terms that it agrees upon may not be favorable
to it, and it may not be able to maintain such strategic collaborations if, for example, development or approval of a product candidate
is delayed or sales of an approved product are disappointing. Any delay in entering into new strategic collaboration agreements related
to Tvardi’s product candidates could delay the development and commercialization of its product candidates and reduce their competitiveness
even if they reach the market.

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The operations of Tvardi’s suppliers, some of which are located outside of the United States, are subject to additional risks that are beyond Tvardi’s control and that could harm its business, financial condition, results of operations and prospects.

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Currently, some of Tvardi’s suppliers are
located outside of the United States. As a result of its global suppliers, Tvardi is subject to risks associated with doing business abroad,
including:

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| ● | political unrest, terrorism, labor disputes and economic instability resulting in the disruption of trade from foreign countries in which Tvardi’s products are manufactured; |

| ● | the imposition of new laws and regulations, including those relating to labor conditions, quality, and safety standards, imports, duties, taxes and other charges on imports, as well as trade restrictions and |

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| restrictions on currency exchange or the transfer of funds, particularly new or increased tariffs imposed on imports from countries where Tvardi’s suppliers operate; |

| ● | greater challenges and increased costs with enforcing and periodically auditing or reviewing Tvardi’s suppliers’ and manufacturers’ compliance with cGMPs or status acceptable to the FDA, EMA or comparable foreign regulatory authorities; |

| ● | reduced protection for intellectual property rights, including trademark protection, in some countries; |

| ● | disruptions in operations due to global, regional or local public health crises or other emergencies or natural disasters; |

| ● | disruptions or delays in shipments; and |

| ● | changes in local economic conditions in countries where Tvardi’s manufacturers or suppliers are located. |

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These and other factors beyond Tvardi’s control
could interrupt Tvardi’s suppliers’ production, influence the ability of Tvardi’s suppliers to export its clinical supplies
cost-effectively or at all, and inhibit Tvardi’s suppliers’ ability to procure certain materials, any of which could harm
its business, financial condition, results of operations and prospects.

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Tvardi’s suppliers and any future collaborators may need assurances that