Company: TVRD
Filing Date: 2025-01-27
Form Type: S-4/A
Source: 0001104659-25-006050
Chunk: 261

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-01-27
Form: S-4/A
Chunk 261
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holder value, Cara was a biopharmaceutical company focused on leading a new treatment paradigm to improve the lives of patients suffering from chronic pruritus. Since 2004, Cara has been focused on organizing and staffing itself, developing its lead product and product candidates, including conducting preclinical studies and clinical trials of difelikefalin-based product candidates, and raising capital. As part of the ongoing consideration and evaluation of its long-term prospects and strategies, the Cara Board frequently reviews, with Cara’s management and outside advisors, strategic and financial alternatives, considering developments in Cara’s business, the sectors in which it competes, the economy generally and financial markets, all with the goal of enhancing value for its stockholders. As part of this process, from time to time, members of Cara’s management and its advisors have engaged in business development and strategic discussions with industry participants, including strategic out-licensing and collaboration arrangements.

On May 7, 2024, the Cara Board held a teleconference meeting with representatives of management and representatives of Cara’s regular outside legal counsel at Cooley LLP also attending. At this meeting, the Cara Board discussed what strategic options Cara would have in the event of negative data from the KOURAGE-1 Part A clinical trial, including prospects for remaining as a standalone company, financing options, dissolution or insolvency and a sale of Cara. The Cara Board discussed its fiduciary duties in connection with each of the discussed options available to Cara in that scenario.

On June 10, 2024, the Cara Board, representatives of Cara management and representatives of Cara’s regular outside legal counsel held separate videoconference meetings with two prospective financial advisors, including Piper Sandler. The representatives of each prospective financial advisor separately presented to the Cara Board regarding the M&A industry landscape and M&A possibilities for Cara, as well as their capabilities with respect to such potential strategic alternatives.

On June 11, 2024, the Cara Board held a videoconference meeting with representatives of Cara management and representatives of Cara’s regular outside legal counsel also attending. The Cara Board reviewed 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 notalgia paresthetica (NP) in which oral difelikefalin did not demonstrate a meaningful clinical benefit at any dose compared to placebo. At this same meeting, the Cara Board discussed again the go-forward strategic options for Cara in light