Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 8

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 8
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 and convenient oral dosing. The Company’s
lead product candidate, TTI-101, is currently in Phase 2 clinical development for hepatocellular carcinoma (HCC). The Company’s
second product candidate, TTI-109, is also an oral, small molecule STAT3 inhibitor that is structurally related to, yet chemically distinct
from, TTI-101 and is designed to enhance the Company’s ability to target STAT3. The Company submitted an Investigational New Drug
application for TTI-109 in June 2025. A Phase 1 trial of TTI-109 in healthy volunteers to evaluate safety, tolerability, and pharmacokinetics,
as well as bioequivalence to TTI-101 is ongoing.

Merger

On December 17, 2024, the Delaware corporation
formerly known as Tvardi Therapeutics, Inc. (Legacy Tvardi) entered into an agreement and plan of merger and reorganization (the Merger
Agreement) with Cara Therapeutics, Inc. (Cara), and CT Convergence Merger Sub, Inc., a wholly-owned subsidiary of Cara (Merger
Sub), pursuant to which Merger Sub merged with and into Legacy Tvardi, with Legacy Tvardi surviving the Merger as a wholly-owned subsidiary
of Cara (such transaction, the Merger). Upon the closing of the Merger on April 15, 2025, Cara changed its corporate name to Tvardi Therapeutics,
Inc. and Legacy Tvardi’s business continued as the business of the Company. Unless otherwise indicated or the context otherwise requires, references in these notes to condensed consolidated financial statements to “Tvardi” and “the Company” refer to the business and operations of Legacy Tvardi prior to the Merger and to Tvardi Therapeutics, Inc. and its consolidated subsidiaries following the Merger. See Note 3, Merger Agreement, for additional information on the
Merger.

Risks and Uncertainties

The Company is subject to risks and uncertainties
common to early-stage companies in the biopharmaceutical industry, including, but not limited to, successful development of TTI-101 and
TTI-109, the development of new technological innovations by competitors, dependence on key personnel, the ability to attract and retain
qualified employees, protection of proprietary technology, compliance with governmental regulations and the ability to secure additional
capital to fund operations and commercial success of TTI-101 and TTI-109. There