Tvardi Therapeutics, Inc.

What they do

Tvardi develops oral small molecule therapies targeting STAT3 for inflammatory and proliferative diseases. Its pipeline consists of TTI-101, a first-generation direct STAT3 inhibitor in a Phase 1b/2 trial in hepatocellular carcinoma, and TTI-109, a phosphate prodrug of TTI-101 that completed a Phase 1 healthy volunteer trial in 2026. The company operates as Tvardi Therapeutics following the April 15, 2025 merger with Cara Therapeutics, in which Legacy Tvardi survived as a wholly-owned subsidiary and Cara was renamed Tvardi Therapeutics.

Revenue drivers

• Product sales — None; the company states it has no products approved for commercial sale and has not generated any revenue to date.
• TTI-101 (hepatocellular carcinoma) — Lead clinical asset in Phase 1b/2 development; would require marketing approval before generating any revenue.
• TTI-109 (ulcerative colitis) — Next-generation prodrug selected for UC as its initial indication; Phase 1 healthy volunteer data reported in July 2026, with a UC trial planned for 2027 subject to IND clearance and additional funding.
• Financing, not operations — Cash has come from equity and debt issuances: $28.3 million from convertible notes in December 2024, $83.4 million from preferred stock and historical convertible debt in 2018 and 2021, and approximately $23.9 million of net assets acquired in the Cara merger.

Recent performance

Second quarter 2026 research and development expenses were $4.0 million versus $5.8 million in the prior-year period, driven by lower TTI-101 clinical costs partly offset by higher TTI-109 development costs. General and administrative expenses were $2.6 million versus $3.1 million. Net loss for the quarter was $6.5 million compared with net income of $4.2 million in the second quarter of 2025, which included a $12.7 million non-cash gain on convertible notes. Cash, cash equivalents and short-term investments were $15.8 million as of June 30, 2026. Full-year 2025 net loss was $18.2 million with operating cash use of $23.5 million, after a $29.4 million net loss in 2024.

Strategy

The company is advancing TTI-109 as its next-generation STAT3 inhibitor, having reported topline healthy volunteer data in July 2026 that confirmed prodrug conversion, dose-proportional pharmacokinetics with exposures above the STAT3 IC50, and reductions of up to 60% in STAT3-driven immune cell populations. It selected ulcerative colitis as the initial TTI-109 indication and plans to initiate a UC clinical trial in 2027, subject to IND clearance and additional funding. TTI-101 remains in the REVERT LIVER CANCER Phase 1b/2 trial, with topline data across three cohorts now expected in the fourth quarter of 2026, after having been extended from the first half of 2026 to allow data to mature. The company also re-analyzed a 12-week subset of the failed Phase 2 IPF trial and reported greater reductions in certain exploratory fibrosis and inflammatory markers versus placebo.

Risks

• No revenue and recurring losses — The company has no approved products or revenue and reported net losses of $18.2 million in 2025 and $29.4 million in 2024, with an accumulated deficit of $110.5 million as of December 31, 2025.
• Limited cash runway — Cash, cash equivalents and short-term investments were $15.8 million as of June 30, 2026, against second-quarter operating costs of $6.6 million in R&D and G&A, and the planned 2027 TTI-109 UC trial is subject to additional funding.
• Clinical failure risk — The Phase 2 IPF trial of TTI-101 did not meet its goals in October 2025, and TTI-101 is only in Phase 1b/2 development in HCC.
• Data timing slippage — The TTI-101 HCC topline readout was extended from the first half of 2026 to the fourth quarter of 2026 to allow data to mature, including up to 15 additional monotherapy participants.

Outlook

Management points to a KOL webinar on TTI-109 in UC on August 19, 2026, TTI-101 Phase 1b/2 HCC topline data in the fourth quarter of 2026, and initiation of a TTI-109 UC clinical trial in 2027 subject to IND clearance and additional funding. The 10-Q states topline TTI-101 data across all three REVERT LIVER CANCER cohorts is expected in the fourth quarter of 2026. No product revenue is expected before approval, and the company states it will need substantial additional capital.