Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 10

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 10
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’s ability to meet its future obligations is inherently judgmental, subjective and susceptible to change.
Given the inherent uncertainties in the forecast, the Company 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 the Company’s ability to continue as a going concern.

To date, the Company has no products approved for
marketing and sale and it has not yet recorded any revenue from product sales. The Company’s ability to achieve profitability is
dependent on its ability to successfully develop its compounds, conduct clinical trials, obtain regulatory approvals, and support commercialization
activities for its product candidates. Any products developed will require approval of the U.S. Food and Drug Administration (FDA) or
a foreign regulatory authority prior to commercial sale.

Since inception, the Company has relied primarily
on sales of redeemable convertible preferred stock and issuance of convertible debt to fund its operations. The Company’s product
candidates are still in the early stages of development, and substantial additional financing will be needed by the Company to fund its
operations and ongoing research and development efforts prior to the commercialization of its product candidates.

The Company also completed the Merger in April 2025.
Significant additional funding is necessary to maintain current operations and to advance the Company’s research and development
activities. The Company plans to seek additional funding through equity offerings or debt financings, credit or loan facilities, and strategic
alliances and licensing arrangements. The Company’s ability to access capital when and in the amount needed is not assured. As a
result, the Company has concluded that management’s plans do not alleviate substantial doubt about the Company’s ability to
continue as a going concern.

The accompanying condensed consolidated financial
statements do not reflect any adjustments relating to the recoverability and reclassifications of assets and liabilities that might be
necessary if the Company is unable to continue as a going concern.

Basis of Presentation

The accompanying condensed consolidated financial
statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America
(GAAP). The accompanying condensed consolidated financial statements represent the accounts of the Company as a result of the consummation
of the Merger in April 2025. All intercompany balances and transactions have been eliminated.

The condensed consolidated financial statements
reflect all adjustments (consisting of normal recurring adjustments) necessary to present fairly the financial position of the Company
as of September 30,