Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 157

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 157
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 safe harbor laws exist, and then use the information learned from such activities to develop competitive products for sale in its major commercial markets; |

| ● | ownership of Tvardi’s patent portfolio may be challenged by third parties; |

| ● | the patents of third parties or pending or future applications of third parties, if issued, may have an adverse effect on its business; |

| ● | patent enforcement is expensive and time-consuming and difficult to predict; thus, Tvardi may not be able to enforce any of its patents against a competitor; and |

| ● | Tvardi may choose not to file a patent application for certain inventions, instead choosing to rely on trade secret protection, and a third party may subsequently file a patent covering such intellectual property. |

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Should any of these events occur, they could significantly
harm Tvardi’s business, financial condition, results of operations and prospects.

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Risks Related to Tvardi’s Reliance on Third Parties

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Tvardi relies on third parties to conduct certain aspects of its preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, Tvardi may not be able to obtain regulatory approval of or commercialize any potential product candidates.

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Tvardi depends upon third parties to conduct certain
aspects of its preclinical studies and clinical trials, under agreements with universities, medical institutions, CROs, strategic collaborators
and others. Tvardi expects to have to negotiate budgets and contracts with such third parties, which may result in delays to its development
timelines and increased costs.

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Tvardi will rely especially heavily on third parties
over the course of its clinical trials, and, as a result, will have limited control over the clinical investigators and limited visibility
into their day-to-day activities, including with respect to their compliance with the approved clinical protocol. Nevertheless, Tvardi
is responsible for ensuring that each of its clinical trials is conducted in accordance with the applicable protocol, legal and regulatory
requirements and scientific standards, and Tvardi’s reliance on third parties does not relieve Tvardi of its regulatory responsibilities.
Tvardi and these third parties are required to comply with Good Clinical Practice (GCP), requirements, which are regulations and guidelines
enforced by the FDA and comparable foreign regulatory authorities for product candidates in clinical development. Regulatory authorities
enforce these GCP requirements through periodic