Company: TVRD
Filing Date: 2025-05-13
Form Type: 10-Q
Source: 0001558370-25-007575
Chunk: 20

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-05-13
Form: 10-Q
Item: Item 8
Chunk 20
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 Legacy Tvardi’s founder’s seminal work and deep understanding of the transcription factor, STAT3, the Combined Company has designed an innovative approach to directly inhibit STAT3, a highly validated, yet historically undruggable target. Leveraging this expertise, the Combined Company is developing a pipeline of STAT3 inhibitors with a differentiated mechanism of action and convenient oral dosing. Tvardi’s 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”). Tvardi’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 Tvardi’s ability to target STAT3. Tvardi expects to submit an Investigational New Drug application for TTI-109 in the first half of 2025.The unaudited interim financial statements included in this Quarterly Report on Form 10-Q are representative of Cara’s operations prior to the closing of the Merger, the adoption of the Company’s business plan and the commencement of conducting Company’s business. Unless the context otherwise requires, references to the “Company” or “Tvardi” refer to Tvardi Therapeutics, Inc. after completion of the Merger. In addition, references to “Cara” refer to the Company prior to the completion of the Merger.Nasdaq Continued Listing Rules​On February 1, 2024, Cara received a letter from The Nasdaq Stock Market (“Nasdaq”) notifying it that, for the previous 30 consecutive business day periods prior to the date of the letter, the closing bid price for Cara’s common