Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 139

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 139
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 Competition
and Patent Term Restoration Act of 1984 permits a Patent Term Extension (PTE), of up to five years beyond the normal expiration of the
patent to compensate patent owners for loss of enforceable patent term due to the lengthy regulatory approval process. A PTE grant cannot
extend the remaining term of a patent beyond a total of 14 years from the date of the product approval. Further, PTE may only be applied
once per product, and only with respect to an approved indication - in other words, only one patent (for example, covering
the product itself, an approved use of said product, or a method of manufacturing said product) can be extended by PTE. Tvardi anticipates
applying for PTE in the United States. Similar extensions may be available in other countries where Tvardi is prosecuting patents, and
Tvardi likewise anticipates applying for such extensions.

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In the United States, Tvardi’s broadest patent,
8,779,001, which protects the use of TTI-101 for inhibiting STAT3, is set to expire on November 13, 2030. Tvardi may potentially apply
PTE and Orphan Drug Exclusivity to the 8,779,001 patent, extending the patent term of the 8,779,001 patent by up to seven years. After
expiration of the 8,779,001 patent, Tvardi’s commercial use of TTI-101 will be protected by formulation patents and manufacturing
patents that Tvardi owns; however these patents provide narrower protection than the 8,779,001 patent. If a competitor designs a formulation
of TTI-101 that is not covered by any of Tvardi’s formulation or manufacturing patents, then Tvardi may not be able to prevent them
from selling their formulation of TTI-101 to inhibit STAT3.

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The granting of patent term extensions is not guaranteed
and is subject to numerous requirements. Tvardi might not be granted an extension because of, for example, failure to apply within applicable
periods, failure to apply prior to the expiration of relevant patents or otherwise failure to satisfy any of the numerous applicable requirements.
In addition, to the extent Tvardi wishes to pursue patent term extension based on a patent that it has in-licensed from BCM or another
third party, Tvardi would need the cooperation of BCM or the other third party. Moreover, the applicable authorities, including the FDA