Cara Therapeutics (Nasdaq: CARA) and Tvardi Therapeutics, a private clinical-stage biopharmaceutical company, recently announced a definitive merger agreement. This all-stock transaction will result in a Nasdaq-listed company focused on developing novel treatments for fibrosis-driven diseases by targeting STAT3. The combined company will operate under the name Tvardi Therapeutics, Inc. and trade under the ticker symbol “TVRD”.
Merger Details and Financial Implications of Cara Stock
Upon completion of the merger, former Cara Stockholders are expected to own approximately 17% of the combined company, while Tvardi investors will own roughly 83%. This distribution is subject to adjustments based on Cara’s net cash balance at closing and the issuance of shares from Tvardi’s recent $28 million private financing. This financing, along with existing cash reserves from both companies, is projected to fund operations into the second half of 2026.
Concurrent with the merger, Cara entered into an asset purchase agreement with Vifor Fresenius Medical Care Renal Pharma, Ltd. (“CSL Vifor”). Cara will sell certain assets and rights related to Korsuva®/Kapruvia® (difelikefalin) to CSL Vifor for $900,000, along with a $3,000,000 payment to offset future expenses for CSL Vifor.
Tvardi’s Promising Pipeline and STAT3 Inhibition
The combined company will prioritize Tvardi’s pipeline of novel, oral, small molecule therapies targeting STAT3, a key driver in fibrosis-driven diseases. This approach offers a potential breakthrough in treating conditions with significant unmet needs.
TTI-101: Leading the Charge in Fibrosis Treatment
Tvardi’s lead candidate, TTI-101, is currently in Phase 2 trials for idiopathic pulmonary fibrosis (IPF) and a Phase 1b/2 trial for hepatocellular carcinoma (HCC). TTI-101 functions as an orally bioavailable, small-molecule inhibitor of STAT3. By inhibiting STAT3 activation, TTI-101 aims to address the underlying causes of fibrosis without disrupting essential biological functions.
The REVERTIPF trial is evaluating TTI-101 in IPF patients, both alone and in combination with nintedanib. Topline data is expected in the second half of 2025. Similarly, the REVERTLIVER CANCER trial is assessing TTI-101 in HCC patients, including in combination with standard treatments like pembrolizumab or atezolizumab and bevacizumab. Preliminary data from this trial is also anticipated in the second half of 2025.
TTI-109: Expanding the STAT3 Inhibitor Portfolio
Tvardi’s second candidate, TTI-109, is structurally related to TTI-101 but designed for enhanced STAT3 targeting. An Investigational New Drug (IND) application for TTI-109’s first human study is expected in the first half of 2025.
Leadership and Future Direction
Post-merger, the company will be headquartered in Houston, Texas, under the leadership of Tvardi’s CEO, Imran Alibhai, Ph.D., and his management team. The board will consist of six directors from Tvardi and one from Cara.
The merger, pending stockholder and regulatory approvals, is expected to close in the first half of 2025. This strategic move positions the new Tvardi Therapeutics as a key player in developing innovative therapies for fibrosis-driven diseases, offering potential long-term value for investors currently holding Cara stock. The focus on STAT3 inhibition, coupled with a robust pipeline, presents a compelling investment thesis in the biopharmaceutical space.
