**Tvardi Therapeutics, Inc. Reports 2025 Financial Results and Provides Business Update**

Tvardi Therapeutics, Inc. (Nasdaq: TVRD), a clinical-stage biopharmaceutical company, today announced its financial results for the year ended December 31, 2025. The company, which was formed through a reverse merger with Cara Therapeutics, Inc. in April 2025, reported a net loss of $18.2 million for 2025, compared to a net loss of $29.4 million for 2024. The decrease in net loss was primarily driven by a $5.6 million decrease in research and development expenses, partially offset by a $4.3 million increase in general and administrative expenses. Tvardi has not generated any revenue to date.

Research and development expenses totaled $18.0 million in 2025, a decrease from $23.7 million in 2024. This decrease was mainly due to reduced spending on the TTI-101 program, specifically in hepatocellular carcinoma (HCC), idiopathic pulmonary fibrosis (IPF), and metastatic breast cancer (mBC) trials. These decreases were partially offset by a $4.2 million increase in TTI-109 related CMC and clinical operations costs. General and administrative expenses increased to $8.7 million in 2025 from $4.5 million in 2024, primarily due to higher professional fees associated with the merger and increased insurance costs. Interest income increased to $1.4 million in 2025 from $0.7 million in 2024, reflecting interest earned on cash, cash equivalents, and short-term investments. Other income, net, was $7.2 million for 2025, primarily due to a $12.8 million remeasurement gain on convertible notes, partially offset by a $4.9 million remeasurement loss recorded during the first quarter of 2025, as well as a total of $0.7 million in interest accrued on the Convertible Notes during those respective periods.

Key operational developments included the initiation of a Phase 1 clinical trial for TTI-109 in healthy volunteers following FDA acceptance of the Investigational New Drug (IND) application in June 2025. The company also extended the timing of the anticipated data readout from the REVERT LIVER CANCER Phase 1b/2 clinical trial of TTI-101 in patients with HCC from the first half of 2026 to the second half of 2026 in order to allow the data to mature. As of December 31, 2025, Tvardi had 12 full-time employees, with 8 dedicated to research and development activities.

Looking ahead, Tvardi expects to report topline data from the TTI-109 Phase 1 trial in the second quarter of 2026 and announce the clinical indication for Phase 2 development thereafter. The company also anticipates reporting topline data from the REVERT LIVER CANCER trial in the second half of 2026. Tvardi Therapeutics, Inc. had cash and cash equivalents and short-term investments of $20.7 million and $10.1 million, respectively, as of December 31, 2025. The company anticipates that it will need to raise additional capital to fund its operations and complete its ongoing and planned clinical trials.

About Tvardi Therapeutics, Inc.

Cara Therapeutics is a biopharmaceutical company focused on developing and commercializing therapies for chronic pruritus. Its lead product, difelikefalin, is approved for treating pruritus associated with advanced chronic kidney disease in multiple countries. The company engages in licensing, collaboration, and royalty arrangements, with a business model centered on drug development, strategic partnerships, and out-licensing to maximize global reach and shareholder value.

This description was generated via AI from an annual report. Updated 8 months ago.

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