Company: TVRD
Filing Date: 2025-03-11
Form Type: 10-K
Source: 0001558370-25-002705
Chunk: 20

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-03-11
Form: 10-K
Item: Item 1
Chunk 20
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Item 1. Business.

Overview

Cara is a biopharmaceutical company that has been focused on leading a new treatment paradigm to improve the lives of patients suffering from chronic pruritus. Cara has developed an IV formulation of difelikefalin, which is approved for the treatment of moderate-to-severe pruritus associated with advanced chronic kidney disease in adults undergoing hemodialysis in the United States, the European Union, or EU, and multiple other countries. The IV formulation is out-licensed worldwide. 

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On June 14, 2024, Cara’s Board of Directors approved a streamlined operating plan exploring strategic alternatives focused on maximizing shareholder value after Cara announced its decision to discontinue the clinical program in notalgia paresthetica, or NP, on June 12, 2024. Cara’s decision to discontinue the clinical program in NP followed the outcome from the dose-finding Part A of the KOURAGE-1 study evaluating the efficacy and safety of oral difelikefalin for moderate-to-severe pruritus in adult patients with NP in which oral difelikefalin did not demonstrate a meaningful clinical benefit at any dose compared to placebo. The decision was not related to any safety or medical issues, or negative regulatory feedback related to the NP program. In connection with the streamlined operating plan, Cara’s Board of Directors also approved a second reduction in Cara’s workforce by approximately 70%, which was substantially completed by June 30, 2024 (see Note 19 of Notes to Consolidated Financial Statements, Commitments and Contingencies – Restructuring Actions, in this Annual Report on Form 10-K.) 

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On December 30, 2024, Cara effected a one-for-twelve (12) reverse stock split and corresponding proportionate reduction in the total number of authorized shares of Cara’s common stock. All share and per share amounts in this Annual Report on Form 10-K, unless otherwise noted, reflect the reverse stock split (see Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations – Corporate Update).