Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 9

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 9
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 can be no assurance that the Company’s research
and development will be successfully completed, that adequate protection for the Company’s intellectual property will be maintained,
that any therapeutic products developed will obtain required regulatory approval or that any approved or consumer products will be commercially
viable. Even if the Company’s development efforts are successful, it is uncertain when, if ever, the Company will generate significant
product sales.

Additionally, the Company is subject to risks
and uncertainties as a result of global business, political and macroeconomic events and conditions, including increasing financial
market volatility and uncertainty, inflation, interest rate fluctuations, uncertainty with respect to the federal budget and debt ceiling,
as well as the potential for future potential government shutdowns related thereto, potential instability in the global banking system,
cybersecurity events, the impact of war or military conflict, including regional conflicts around the world, and public health pandemics.
The extent to which business, political and macroeconomic factors, including increasing financial market volatility and uncertainty, will
impact the Company’s business will depend on future developments that are highly uncertain and cannot be predicted at this time.

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Table of Contents

Liquidity and Going Concern

The accompanying condensed consolidated financial
statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets
and satisfaction of liabilities in the normal course of business.

As of September 30, 2025, the Company had cash
and cash equivalents and short-term investments of $21.4 million and $15.0 million, respectively, which included approximately $23.9 million
in net assets acquired from the consummation of the Merger Agreement (as further discussed in Note 3, Merger Agreement) in April
2025. Since inception, the Company has incurred net operating losses and negative cash flows from operations. During the three and nine
months ended September 30, 2025, the Company incurred net losses of $5.5 million and $10.9 million, respectively, and used $17.8
million of cash in operating activities during the nine months ended September 30, 2025. As of September 30, 2025, the Company had
an accumulated deficit of $103.2 million. The Company expects to continue to incur significant operating losses for the foreseeable future
and may never become profitable. Losses are expected to continue as the Company continues to invest in research and development activities.
The assessment of the Company