Company: TVRD
Filing Date: 2025-05-30
Form Type: S-1
Source: 0001104659-25-054853
Chunk: 125

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-05-30
Form: S-1
Chunk 125
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 March 31, 2025 is set forth below.

While the legal acquirer in the Merger was Cara, for financial accounting and reporting purposes under U.S. GAAP, Legacy Tvardi was the accounting acquirer and the Merger was accounted for as a “reverse recapitalization.” A reverse recapitalization (i.e., a capital transaction involving the issuance of stock by Cara for Legacy Tvardi’s stock) does not result in a new basis of accounting, and the consolidated financial statements of the combined entity will represent the continuation of the financial statements of Legacy Tvardi in many respects. Accordingly, the assets, liabilities and results of operations of Legacy Tvardi became the historical financial statements of the Company, and Cara’s assets, liabilities and results of operations were consolidated with those of Legacy Tvardi beginning on the acquisition date. Operations prior to the Merger will be presented as those of Legacy Tvardi in future reports. Cara’s assets and liabilities will be measured and recognized at their fair values as of the effective time of the Merger.

#### Overview
We are a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat fibrosis-driven diseases with significant unmet need. Based upon our founder’s seminal work and deep understanding of the transcription factor STAT3, we have designed an innovative approach to directly inhibit STAT3, a highly validated, yet historically undruggable target. Leveraging this expertise, we are developing a pipeline of STAT3 inhibitors with a differentiated mechanism of action and convenient oral dosing. Our lead product candidate, TTI-101, is currently in Phase 2 clinical development for the treatment of fibrosis-driven diseases, with an initial focus on idiopathic pulmonary fibrosis (“IPF”), and hepatocellular carcinoma (“HCC”). We expect to report unblinded data from our Phase 2 IPF clinical trial in the fourth quarter of 2025 and anticipate preliminary topline data from our Phase 1b/2 HCC clinical trial in the first half of 2026. Our 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 our ability to target STAT3. We expect to submit an Investigational New Drug (“IND”) application for TTI-109 in the first half of 2025.

Since commencing operations in 2017, we