Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 161

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 161
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 order to comply with regulatory standards,
such as cGMPs. In the event that any of Tvardi’s manufacturers fails to comply with such requirements or to perform its obligations
to Tvardi in relation to quality, timing or otherwise, or if its supply of components or other materials becomes limited or interrupted
for other reasons, Tvardi may be forced to manufacture the materials itself, for which it currently does not have the capabilities or
resources, or enter into an agreement with another third party, which Tvardi may not be able to do on reasonable terms, if at all. In
some cases, the technical skills or technology required to manufacture Tvardi’s product candidates may be unique or proprietary
to the original manufacturer and Tvardi may have difficulty transferring such skills or technology to another third party and a feasible
alternative may not exist. These factors would increase Tvardi’s reliance on such manufacturer or require Tvardi to obtain a license
from such manufacturer in order to have another third party manufacture its product candidates. If Tvardi is required to change manufacturers
for any reason, it will be required to verify that the new manufacturer maintains facilities and procedures that comply with quality standards
and with all applicable regulations and guidelines. The delays associated with the verification of a new manufacturer could negatively
affect Tvardi’s ability to develop product candidates in a timely manner or within budget.

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Tvardi expects to continue to rely on third-party
manufacturers for commercial supply of drug product, if it receives regulatory approval for TTI-101, TTI-109 or any other product candidate.
To the extent that Tvardi has existing, or enters into future, manufacturing arrangements with third parties, it will depend on these
third parties to perform their obligations in a timely manner consistent with contractual and regulatory requirements, including those
related to quality control and assurance. If Tvardi is unable to obtain or maintain third-party manufacturing for product candidates,
or to do so on commercially reasonable terms, Tvardi may not be able to develop and commercialize its product candidates successfully.
Tvardi’s or a third party’s failure to execute on its manufacturing requirements and comply with cGMP could adversely affect
its business in a number of ways, including:

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| ● | an inability to initiate or continue clinical trials of product candidates under development; |

| ● | delay in submitting regulatory applications, or receiving regulatory approvals, for product candidates; |

| ● | loss of the cooperation of an existing or future