Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 68

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 68
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 each on the worldwide net sales of TTI-101 and any derivative formulations
(a Royalty Bearing Product). These royalty obligations last, on a country-by-country basis, for the later of (i) the date on which
the sale of Royalty Bearing Product is no longer covered by a Covered Patent (as defined below) in such country, or (ii) 15 years
after the first commercial sale of Royalty Bearing Product in such country. The timing of when Tvardi’s royalty payments will actually
be made is uncertain as the payments are contingent upon future activities, including the successful development, regulatory approval
and commercialization of Royalty Bearing Product. A Covered Patent means, subject to certain customary exceptions, an issued patent that
is owned by us or an affiliate, or for which all rights to develop and commercialize pharmaceutical products for the treatment of any
human disorder, are exclusively licensed to Tvardi or an affiliate by the owner of such patent, with Tvardi’s right or Tvardi’s
affiliate’s right to grant sublicenses.

Critical Accounting Estimates

Tvardi’s unaudited condensed consolidated
financial statements are prepared in accordance with U.S. GAAP. The preparation of the unaudited condensed consolidated financial statements
and related disclosures requires management to make estimates and judgments that affect the reported amounts of assets, liabilities and
expenses in Tvardi’s unaudited condensed consolidated financial statements. Tvardi bases its estimates on historical experience,
known trends and events and various other factors that management believes are reasonable under the circumstances, the results of which
form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.
Management evaluates estimates and assumptions on a periodic basis. Tvardi’s actual results may differ from these estimates.

While Tvardi’s significant accounting policies
are described in more detail in Note 2 to the unaudited condensed consolidated financial statements for the three and nine months
ended September 30, 2025 and 2024, included elsewhere within this Quarterly Report, management believes that the following accounting
policies are critical to understanding Tvardi’s historical and future performance, as the policies relate to the more significant
areas involving management’s judgments and estimates used in the preparation of the unaudited condensed consolidated financial statements.

Prepaid and Accrued Research and Development Costs

Accounting for preclinical studies and clinical
trials relating to activities performed by CROs and other external vendors requires management to exercise