Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 123

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 123
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 and abuse or other healthcare laws and regulations. If Tvardi’s
operations are found to be in violation of any such requirements, it may be subject to significant penalties, including civil, criminal
and administrative penalties, damages, fines, disgorgement, imprisonment, the curtailment or restructuring of its operations, loss of
eligibility to obtain approvals from the FDA, exclusion from participation in government contracting, healthcare reimbursement or other
government programs, including Medicare and Medicaid, integrity oversight and reporting obligations or reputational harm, any of which
could adversely affect its financial results. These risks cannot be entirely eliminated. Any action against Tvardi for an alleged or suspected
violation could cause it to incur significant legal expenses and could divert management’s attention from the operation of its business,
even if the defense is successful. In addition, achieving and sustaining compliance with applicable laws and regulations may be costly
to Tvardi in terms of money, time and resources.

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If Tvardi fails to comply with environmental, health and safety laws and regulations, it could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of its business.

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Tvardi is subject to numerous environmental, health
and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal
of hazardous materials and wastes. Tvardi’s research and development activities involve the use of biological and hazardous materials
and produce hazardous waste products. Tvardi generally contracts with third parties for the disposal of these materials and wastes. Tvardi
cannot eliminate the risk of contamination or injury from these materials, which could cause an interruption of its commercialization
efforts, research and development efforts and business operations, environmental damage resulting in costly clean-up and liabilities under
applicable laws and regulations governing the use, storage, handling and disposal of these materials and specified waste products. Although
Tvardi believes that the safety procedures utilized by its third-party manufacturers for handling and disposing of these materials generally
comply with the standards prescribed by these laws and regulations, it cannot guarantee that this is the case or eliminate the risk of
accidental contamination or injury from these materials. In such an event, Tvardi may be held liable for any resulting damages and such
liability could exceed its resources and state or federal or other applicable authorities may curtail its use of certain materials and/or
interrupt its business operations. Furthermore, environmental laws and regulations are complex, change frequently and have tended