On March 31, 2026 Tvardi Therapeutics, Inc. ("Tvardi") (NASDAQ: TVRD), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat inflammatory and proliferative diseases, reported its financial and operating results for the fourth quarter and full-year ended December 31, 2025, and provided a business update.
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Recent Highlights:
Additional analysis from the REVERT IPF Phase 2 trial demonstrated that TTI-101 was associated with a 9.4% baseline-weighted reduction in fibrosis score compared to 2.4% for placebo, as well as a 4.5-fold greater decline in IL-6, a central STAT3-driven inflammatory cytokine. These findings are consistent with preclinical data demonstrating reductions in established fibrosis and inflammatory signaling across multiple validated disease models.
The healthy volunteer study of its next-generation STAT3 inhibitor, TTI-109, is ongoing, with topline data anticipated in the second quarter of 2026.
The ongoing Phase 1b/2 REVERT LIVER CANCER trial will report topline results in the second half of 2026 to allow the data additional time to mature. This timing adjustment is intended to enhance the depth of insights gleaned from the program, including longitudinal and translational assessments, characterization of durability and dose optimization (including the addition of up to 15 participants in the monotherapy arm to explore once-a-day dosing), to better inform subsequent development and regulatory strategy.
Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi, stated, "We entered 2026 with line-of-site to two significant clinical milestones: 1) healthy volunteer data from our next-generation STAT3 inhibitor, TTI-109, in the second quarter of this year, and 2) topline data from our ongoing Phase 2 trial of TTI-101 in HCC, which we anticipate in the second half."
"Further analysis of data from our Phase 2 IPF trial of TTI-101 that we announced in October revealed compelling trends. These data give us optimism for TTI-109, which has been developed to enhance TTI-101’s ability to target STAT3 as a more efficient delivery vehicle with the potential to improve tolerability."
"At the same time, we eagerly await data from our ongoing Phase 2 REVERT LIVER CANCER trial, with a data readout expected in the second half of this year to allow for further data maturation. Interim results from this study have already shown clinically meaningful activity of TTI-101 both as monotherapy and in combination with established anti-cancer agents across treatment lines, and we believe the broader dataset will better position us to define the optimal development path and regulatory strategy for this important program."
"I believe we are well positioned to continue to advance these promising molecules, potentially offering new hope to patients requiring new, more effective treatment options while creating enduring value for our company," Dr. Alibhai concluded.
Upcoming Milestones:
Preliminary topline data from a healthy volunteer study of the company’s next-generation STAT3 inhibitor, TTI-109, anticipated in the second quarter of 2026
Preliminary topline data from the company’s ongoing REVERT LIVER CANCER Phase 1b/2 clinical trial of TTI-101, anticipated in the second half of 2026
Fourth Quarter and Full-Year 2025 Financial Results
Research and development expenses for the three months ended December 31, 2025, were $5.5 million as compared to $8.6 million for the comparable period in 2024. For the full year 2025, research and development expenses were $18.0 million, as compared to $23.7 million for the full year 2024. The decrease was primarily driven by declining clinical costs associated with TTI-101 offset by an increase in TTI-109 developmental costs.
General and administrative expenses were $2.1 million for the three months ended December 31, 2025, as compared to $2.2 million for the three months ended December 31, 2024. For the full year 2025, general and administrative expenses were $8.7 million, as compared to $4.5 million for the full year 2024. The increase was primarily driven by increases in professional fees, attributable to increased legal, accounting and audit fees incurred as a result of the merger with Cara Therapeutics and subsequent filings as a public company.
Net loss for the three months ended December 31, 2025, was $7.3 million, as compared to a net loss of $12.7 million for the comparable period in 2024. For the full year 2025, net loss was $18.2 million, as compared to a net loss of $29.4 million for the full year 2024.
Basic and diluted net loss per share attributable to common shareholders for the three months ended December 31, 2025, were a net loss of $(0.78) on a basic and diluted basis, compared to a net loss of $(4.94) on a basic and diluted basis for the comparable period in 2024. For the full year 2025, basic and diluted net loss attributable to common stockholders were $(2.46) and $(3.26), respectively, as compared to basic and diluted loss attributable to common stockholders of $(11.42) for the full year 2024.
Cash, cash equivalents and short-term investments as of December 31, 2025, were $30.8 million, as compared to $31.6 million as of December 31, 2024. Tvardi anticipates that its current cash runway is sufficient to fund operations, as currently planned, through clinical readouts and into the fourth quarter of 2026.
(Press release, Tvardi Therapeutics, MAR 31, 2026, View Source [SID1234664107])