Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 145

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 145
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 its competitive position, Tvardi may become involved in lawsuits asserting
infringement of its own or in-licensed patents, or misappropriation or other violations of other of its intellectual property rights.
Litigation is expensive and time consuming and would likely divert the time and attention of its management and scientific personnel.
There can be no assurance that Tvardi will have sufficient financial or other resources to file and pursue such infringement claims, which
typically last for years before they are concluded. Even if Tvardi ultimately prevails in such claims, the monetary cost of such litigation
and the diversion of the attention of its management and scientific personnel could outweigh any benefit it receives as a result of the
proceedings.

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If Tvardi files a patent infringement lawsuit against
a perceived infringer, such a lawsuit could provoke the defendant to counterclaim that it infringes their patents and/or that its own
or in-licensed patents are invalid and/or unenforceable. In patent litigation in the United States, it is commonplace for a defendant
to counterclaim alleging invalidity and/or unenforceability. In any patent litigation there is a risk that a court will decide that the
asserted patents are invalid or unenforceable, in whole or in part, and that Tvardi does not have the right to stop the defendant from
using the invention at issue. With respect to a counterclaim of invalidity, Tvardi cannot be certain that there is no invalidating prior
art of which it and the patent examiner were unaware during prosecution. There is also a risk that, even if the validity of such patents
is upheld, the court will construe the patent claims narrowly or decide that Tvardi does not have the right to stop the other party from
using the invention at issue on the grounds that its patent claims do not cover the invention. If any of Tvardi’s own or in-licensed
patents are found invalid or unenforceable, or construed narrowly, its ability to stop the other party from launching a competitive product
would be materially impaired. Further, such adverse outcomes could limit Tvardi’s ability to assert those patents against future
competitors. Loss of patent protection would have a material adverse impact on its business.

​

Even if Tvardi establishes infringement of any of
its own or in-licensed patents by a competitive product, a court may decide not to grant an injunction against further infringing activity,
thus allowing the competitive product to continue to be