Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 126

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 126
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Inadequate funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of Tvardi’s business may rely, which could negatively impact its business.

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The ability of the FDA to review and approve new
products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel
and accept the payment of user fees and statutory, regulatory and policy changes. Average review times at the agency have fluctuated in
recent years as a result. In addition, government funding of the FDA and other government agencies on which Tvardi’s operations
may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid
and unpredictable.

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Disruptions at the FDA and other agencies may also
slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect Tvardi’s
business. For example, over the last several years, the U.S. government has shut down several times and certain regulatory agencies, such
as the FDA and the SEC, have had to furlough critical employees and stop critical activities, including the most recent shutdown in October
and November 2025. If another prolonged government shutdown occurs, or if global health concerns prevent the FDA or other regulatory authorities
from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA
to timely review and process Tvardi’s regulatory submissions, which could have a material adverse effect on Tvardi’s business.
Further, in Tvardi’s operations as a public company, future government shutdowns could impact its ability to access the public markets
and obtain necessary capital in order to properly capitalize and continue its operations.

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Tvardi is subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions and other trade laws and regulations. Tvardi can face serious consequences for violations.

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Among other matters, U.S. and foreign anti-corruption,
anti-money laundering, export control, sanctions and other trade laws and regulations, which are collectively referred to as Trade Laws,
prohibit companies and their employees, agents, contract research organizations, legal counsel, accountants, consultants, contractors
and other partners from authorizing, promising