Tvardi Therapeutics, Inc. (TVRD) reported fourth-quarter and full-year 2025 financial results and highlighted progress across its STAT3-targeted pipeline, including upcoming data readouts for both its next-generation inhibitor TTI-109 and its lead candidate TTI-101.
The company said its cash runway is expected to support operations into the fourth quarter of 2026, carrying it through multiple clinical milestones.
Financial Results
For the fourth quarter of 2025, Tvardi posted a net loss of $7.3 million, or $(0.78) per diluted share, an improvement from $12.7 million, or $(4.94) per diluted share, in the same period of 2024.
For the full year, net loss narrowed to $18.2 million, or $(3.26) per diluted share attributable to common stockholders, as compared to a net loss of $29.4 million, or $(11.42) per diluted share attributable to common stockholders, in 2024.
Clinical and Pipeline Progress
The company's pipeline includes TTI-109, TTI-101 for hepatocellular carcinoma, and TTI-101 for idiopathic pulmonary fibrosis, each advancing toward key clinical milestones in 2026.
Tvardi continues to advance its portfolio of oral STAT3 inhibitors, which are designed to block activated STAT3- a key driver of inflammation, fibrosis, and cancer progression.
TTI-109 the company's next-generation STAT3 inhibitor, is being evaluate in a Phase 1 healthy volunteer study. Topline results remain on track for the second quarter of 2026.
TTI-101, being studied in hepatocellular carcinoma in the REVERT LIVER CANCER Phase 1b/2 trial, is now expected to report topline results in the second half of 2026, allowing additional time for data maturation, durability assessments, and dose-optimization analyses. Interim results have already shown clinically meaningful activity both as monotherapy and in combination with standard anti-cancer agents.
TTI-101, is also being studied in idiopathic pulmonary fibrosis in the REVERT IPF Phase 2 trial, demonstrated a 9.4% reduction in fibrosis score versus 2.4% with placebo, along with a 4.5-fold greater decline in IL-6, a key STAT3-driven inflammatory cytokine. These findings support the therapeutic potential of STAT3 inhibition in fibrotic lung disease.
CEO Imran Alibhai, Ph.D., said the company enters 2026 with "line-of-sight to two significant clinical milestones"- the TTI-109 healthy volunteer data and the TTI-101 HCC Phase 1b/2 readout. He added that deeper analysis of the IPF dataset strengthens confidence in the broader STAT3 program and the potential for improved tolerability with TTI-109.
Tvardi ended 2025 with $30.8 million in cash, cash equivalents, and short-term investments. The company expects this to fund operations into Q4 2026, including its upcoming clinical readouts.
The company implemented a 1-for-3 reverse stock split on April 14, 2025.
TVRD Tuesday's trading at $3.18, down 0.62%.
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