Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 85

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 85
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 profitable would decrease the value of the Company and could impair its ability to raise capital, maintain
research and development efforts, expand its business or continue its operations.

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Table of Contents

Tvardi’s financial condition raises substantial doubt as to its ability to continue as a going concern.

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As a result of the Merger, Cara’s historic
business operations ceased, and Tvardi’s go-forward business operations are Legacy Tvardi’s. Tvardi’s primary uses of
cash are to fund its operations, which consist primarily of research and development costs related to the development of its product candidates,
and, to a lesser extent, general and administrative costs. Tvardi’s net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of its clinical development activities and other research and development activities. Tvardi expects to continue to incur significant operating losses for the foreseeable future and may never become profitable. Losses are expected to continue as Tvardi continues to invest in research and development activities. The assessment of Tvardi’s ability to meet its future obligations is inherently judgmental, subjective and susceptible to change. Given the inherent uncertainties in the forecast, Tvardi considered both quantitative and qualitative factors that are known or reasonably knowable as of the date that these condensed consolidated financial statements are issued and concluded that there are conditions present in the aggregate that raise substantial doubt about Tvardi’s ability to continue as a going concern. Tvardi has based this estimate on assumptions that
may prove to be wrong.

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In April 2025, as further discussed above, Tvardi
completed its Merger with Cara, through which it acquired approximately $23.9 million in net assets. Tvardi will require additional funding in order to finance operations and complete its ongoing and planned clinical trials. Tvardiplans to
seek additional funding through equity offerings or debt financings, credit or loan facilities, and strategic alliances and licensing
arrangements. However, there can be no assurance that such funding will be available to Tvardi, will be obtained on terms favorable to
Tvardi, or will provide Tvardi with sufficient funds to meet its objectives.

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Tvardi will require substantial additional capital to fund its operations. If Tvardi is unable to raise such capital when needed, or on acceptable terms, it may be forced to delay, reduce and/or eliminate one or more of its research and drug development programs, future commercialization