Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 103

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 103
---
 make decisions on the allocation of resources to certain programs and product candidates; these decisions may prove to be wrong and may adversely affect its business.

​

Tvardi has limited financial and human resources
and intends to initially focus on research programs and product candidates for a limited set of indications. As a result, it may forgo
or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater commercial potential
or a greater likelihood of success. In addition, Tvardi seeks to accelerate its development timelines, including by initiating certain
clinical trials of its product candidates before earlier-stage studies have been completed. This approach may cause Tvardi to commit significant
resources to prepare for and conduct later-stage clinical trials for one or more product candidates that subsequently fail earlier-stage
clinical testing. Therefore, resource allocation decisions may cause Tvardi to fail to capitalize on viable commercial products or profitable
market opportunities or expend resources on product candidates that are not viable.

​

There can be no assurance that Tvardi will ever
be able to identify additional therapeutic opportunities for its product candidates or to develop suitable potential product candidates
through internal research programs, which could materially adversely affect its future growth and prospects. Tvardi may focus its efforts
and resources on potential product candidates or other potential programs that ultimately prove to be unsuccessful.

​

Tvardi may in the future conduct clinical trials for current or future product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such clinical trials.

​

Tvardi may in the future choose to conduct one or
more clinical trials outside the United States. The acceptance of study data from clinical trials conducted outside the United States
or another jurisdiction by the FDA or comparable foreign regulatory authority may be subject to certain conditions or may not be accepted
at all. In cases where data from foreign clinical trials are intended to serve as the basis for marketing approval in the United States,
the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the U.S. population
and U.S. medical practice, (ii) the clinical trials were performed by clinical investigators of recognized competence and (iii) the data
may be considered valid without the need for an on-site inspection by the FDA, or, if the FDA considers such an inspection to be necessary,
the FDA is able to validate the

<div align='center'>62</div>

Table of Contents

data through an on-site inspection or other appropriate means