Cara Therapeutics and Tvardi Therapeutics to Merge, Forming New Biopharma Leader

Key Points:
– Cara Therapeutics and Tvardi Therapeutics announce an all-stock merger, set to create a Nasdaq-listed biopharmaceutical company.
– Tvardi’s recent $28 million financing strengthens the combined company’s financial outlook, funding operations into 2026.
– The new entity will focus on developing STAT3 inhibitors for fibrosis-driven diseases, with Phase 2 data expected in 2025.

Cara Therapeutics (Nasdaq: CARA) and Tvardi Therapeutics have announced a definitive merger agreement, marking a significant step in the development of innovative treatments for fibrosis-driven diseases. The all-stock transaction will combine Cara’s resources with Tvardi’s promising pipeline, including its lead candidate, TTI-101, a small-molecule STAT3 inhibitor. The combined entity will be Nasdaq-listed under the name Tvardi Therapeutics, Inc. and is expected to trade under the ticker symbol “TVRD” once the deal closes in the first half of 2025, subject to regulatory and shareholder approvals.

The merger will give pre-merger Cara stockholders an estimated 17% stake in the new company, while Tvardi investors will own around 83%, assuming Cara’s cash balance at closing falls within the expected range. This transaction comes after Tvardi completed a $28 million private financing round, which, alongside the combined company’s cash, will provide funding into 2026, supporting clinical development through critical data readouts expected in 2025.

Tvardi’s pipeline, which is focused on fibrosis-driven diseases, will be the cornerstone of the merged company’s future. The lead candidate, TTI-101, is currently in Phase 2 trials for idiopathic pulmonary fibrosis (IPF) and Phase 1b/2 trials for hepatocellular carcinoma (HCC). The drug is designed to inhibit STAT3, a central transcription factor involved in the progression of these diseases. Early-stage data from the clinical trials is expected to be reported in the second half of 2025, potentially marking significant inflection points for the company.

In addition to TTI-101, Tvardi is developing TTI-109, another STAT3 inhibitor that is set to enter clinical trials in 2025. Tvardi’s innovative approach to targeting STAT3 positions the combined company as a key player in addressing serious, chronic diseases with significant unmet medical need.

The new company will be headquartered in Houston, Texas, and led by Tvardi CEO Imran Alibhai, Ph.D. The board will consist of members from both Cara and Tvardi, with six directors from Tvardi and one from Cara. This leadership structure is expected to ensure a seamless transition as the combined company moves forward with its mission to develop novel, oral therapies for fibrosis-driven diseases.

This merger comes at a time when the biopharmaceutical sector is increasingly focused on addressing complex diseases with limited treatment options. With a strong financial foundation, a promising pipeline, and a leadership team well-versed in the challenges of drug development, the combined company is poised to make significant strides in the field.

As the merger progresses, investors and industry watchers will be closely monitoring upcoming clinical trial results and further developments in the company’s pipeline, which could position Tvardi Therapeutics as a leader in the treatment of fibrosis-driven diseases.

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