Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 46

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 46
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 study was primarily driven by gastrointestinal adverse events, with higher rates of events and discontinuations
among patients on concurrent nintedanib.

Our second product candidate, TTI-109, is an oral, small-molecule, prodrug of, and mechanistically identical to, TTI-101. TTI-109 itself does not inhibit STAT3 but rapidly converts to TTI-101 in the blood. TTI-109 is designed to rapidly convert to TTI-101 and lessen the
exposure of the active drug to the intestinal lining. We therefore believe that TTI-109 enhances our ability to target STAT3 with a more efficient delivery vehicle for TTI-101 that has the potential to improve tolerability. 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 and Tvardi expects to report out topline data from this trial in the first half of 2026.

Reverse Merger

On December 17, 2024, Legacy Tvardi entered
into an agreement and plan of merger and reorganization (the Merger Agreement) with Cara and CT Convergence Merger Sub, Inc., a wholly-owned
subsidiary of Cara (Merger Sub), pursuant to which, on April 15, 2025, Merger Sub merged with and into Legacy Tvardi, with Legacy
Tvardi surviving as a wholly-owned subsidiary of Cara (the Merger). Upon completion of the Merger, Cara changed its name to Tvardi Therapeutics, Inc.,
and Legacy Tvardi’s business continued as the business of Tvardi.

Pursuant to the terms and conditions of the Merger
Agreement, at the effective time of the Merger (the Effective Time):

| ● | the outstanding shares of Legacy Tvardi’s common stock (including the shares of common stock issuable upon conversion of all shares of Legacy Tvardi’s preferred stock prior to the Merger), $0.001 par value per share (Legacy Tvardi common stock), were converted into 6,539,404 shares of Tvardi’s common stock, $0.001 par value per share (Tvardi common stock) in the aggregate, based on an exchange ratio calculated in accordance with the Merger Agreement (the Exchange Ratio); |

| ● | Tvardi acquired approximately $23.9 million in net assets in accordance with