Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 107

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 107
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 Tvardi may face competition with respect to any product candidates that it seeks to develop or commercialize
in the future from major biopharmaceutical companies, specialty biopharmaceutical companies and biotechnology companies worldwide. Potential
competitors also include academic institutions, government agencies and other public and private research organizations that conduct research,
seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization.

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Table of Contents

There are a number of biopharmaceutical and biotechnology
companies that are currently pursuing the development of products for the treatment of fibrosis-driven diseases. Companies that Tvardi
is aware of that are targeting the treatment of various fibrosis indications include companies with significantly more financial resources
such as AbbVie Inc., AstraZeneca plc, Bristol Myers Squibb Co., Merck & Co., Inc., Novartis AG, Scholar Rock Inc. and Takeda Pharmaceutical
Company. Companies that Tvardi is aware of that are targeting the treatment of the HCC indication include large companies such as Novartis
AG, Bristol Myers Squibb Co., Roche AG, AstraZeneca plc, AbbVie Inc. and Bayer AG.

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Many of Tvardi’s current or potential competitors,
either alone or with their strategic partners, have significantly greater financial resources and expertise in research and development,
manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than Tvardi
does.

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Mergers and acquisitions in the biopharmaceutical
and biotechnology industries may result in even more resources being concentrated among a smaller number of competitors. Smaller or early-stage
companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.
These competitors also compete with Tvardi in recruiting and retaining qualified scientific and management personnel and establishing
clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary
for, its programs. Tvardi’s commercial opportunity could be reduced or eliminated if competitors develop and commercialize products
that are safer, more effective, more convenient or less expensive than any products that Tvardi may develop. Furthermore, products currently
approved for other indications could be discovered to be effective treatments of fibrosis as well, which could give such products significant
regulatory and market timing advantages over TTI-101, TTI-109 or other product candidates that Tvardi may identify.