Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 188

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 188
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 including the right to correct personal information and
affording opt-out rights for certain uses of sensitive information, and imposes additional data protection obligations on covered businesses,
including additional limitations on data uses and new audit requirements for higher risk sensitive information. The CPRA also established
the California Privacy Protection Agency which is authorized to issue substantive regulations and could result in increased privacy and
information security enforcement. Other states have also passed comprehensive privacy laws, and similar laws are being considered in several
other states, as well as at the federal and local levels. While these state privacy laws, like the CCPA, may or do exempt some data processed
in the context of clinical trials, these laws could have potentially conflicting requirements that further complicate compliance efforts,
and increase legal risk and compliance costs for Tvardi and the third parties upon whom it relies.

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In the event that Tvardi is subject to or affected
by HIPAA, the CCPA, the CPRA or other domestic privacy and data protection laws, any liability from failure to comply with the requirements
of these laws could adversely affect its financial condition. In addition to government activity, privacy advocacy groups and technology
and other industries are considering various new, additional or different self-regulatory standards that may place

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additional burdens on Tvardi. In addition to data privacy and security
laws, Tvardi is also bound by other contractual obligations related to data privacy and security, and its efforts to comply with such
obligations may not be successful.

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Each of these laws, rules, regulations and contractual
obligations relating to data privacy and security, and any other such changes or new laws, rules, regulations or contractual obligations
could impose significant limitations on Tvardi’s business, require changes to Tvardi’s business, or restrict its collection,
use, storage or processing of personal information, which may increase its compliance expenses and make its business more costly or less
efficient to conduct. In addition, any such changes could compromise Tvardi’s ability to develop an adequate marketing strategy
and pursue its growth strategy effectively or even prevent Tvardi from providing certain products in jurisdictions in which it currently
operates and in which Tvardi may operate in the future or incur potential liability in an effort to comply with such legislation, which,
in turn, could adversely affect its business, financial condition, results of operations and prospects.

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Complying with these numerous, complex and often
changing obligations is expensive