Cara and Tvardi Therapeutics Announce Merger Agreement

Cara Therapeutics, Inc. and Tvardi Therapeutics, Inc. have announced a definitive merger agreement to form a Nasdaq-listed biopharmaceutical company specializing in the development of treatments targeting STAT3 for fibrosis-driven diseases. Tvardi has recently completed a $28 million private financing, which, when combined with Cara's anticipated cash reserve, is expected to support the merged company's operations until the latter half of 2026.

The merger will result in Tvardi merging with a wholly owned subsidiary of Cara, and upon completion, Tvardi's investors are projected to own approximately 83% of the new entity, while Cara's stockholders will possess about 17%, subject to adjustments based on Cara's net cash at closing. The merged company will operate under the name Tvardi Therapeutics, Inc., trading under the ticker symbol "TVRD" on Nasdaq.

Tvardi is advancing its pipeline, focusing on STAT3 inhibitors to treat significant unmet needs in fibrosis-driven diseases. Their leading candidate, TTI-101, is in a Phase 2 trial for idiopathic pulmonary fibrosis (IPF) and a Phase 1b/2 trial for hepatocellular carcinoma (HCC). TTI-101 has demonstrated effectiveness in inhibiting STAT3 activation, showing promise in preclinical models of fibrosis-driven diseases.

The combined company will also work on TTI-109, another STAT3-targeting candidate, with an IND application expected in the first half of 2025. The merger is anticipated to close in the first half of 2025, following stockholder approvals and other customary conditions.

Concurrent with the merger, Cara has entered into an asset purchase agreement with Vifor Fresenius Medical Care Renal Pharma, Ltd., to sell certain assets related to the development and commercialization of Korsuva®/Kapruvia® for $900,000. Cara will compensate Vifor with $3 million for the expected future expenses associated with the asset transfer.

The management of the newly merged company will be led by Tvardi's CEO, Imran Alibhai, Ph.D., with the headquarters based in Houston, Texas. The combined board of directors will include six directors from Tvardi and one from Cara. This strategic merger is seen as an opportunity to leverage Tvardi's expertise in STAT3 inhibition with Cara's financial resources, potentially accelerating the development of innovative treatments for fibrosis-driven diseases.