TVRD News & Events

Tvardi Therapeutics provided further updates from its Phase 2 REVERT IPF clinical trial of TTI-101 in idiopathic pulmonary fibrosis, IPF. Preliminary results were announced on October 13, 2025. Additional analysis was conducted to interrogate the impact of STAT3 inhibition using TTI-101 on fibrosis, inflammatory markers and pulmonary function. In order to do so, the additional analysis was limited to patients who were exposed to study drug for 12 weeks. Upon interrogation of pharmacokinetics and adverse events, one patient was removed from the analysis due to receiving less than 60% of the expected dosing; two patients were removed due to no measurable TTI-101 observed in the blood as well as no reported adverse events; and one additional patient was removed as an outlier for the 12-week analysis as their pulmonary function initially improved on treatment, but was subsequently severely impacted by acute bronchitis deemed unrelated to study drug. This resulted in a dataset of 40 patients analyzed: 16 pooled patients treated with TTI-101, and 24 patients treated with placebo.

Cash, cash equivalents and short-term investments as of September 30, 2025, were $36.5 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, into the fourth quarter of 2026. Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi, stated, "While we continue to analyze the results from our REVERT IPF clinical trial to determine the most appropriate path forward, we remain confident in the potential of STAT3 inhibition to address fibrosis-driven diseases. We believe our lead program, TTI-101, has demonstrated encouraging clinical activity in oncology and continues to hold promise across a range of indications where STAT3 is a key driver. To that end, we eagerly await data from our ongoing Phase 2 REVERT Liver Cancer trial in the first half of next year. 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. At the same time, we are also advancing our next-generation STAT3 inhibitor, TTI-109, through a healthy volunteer study. TTI-109 is designed to rapidly convert to TTI-101 and lessen the exposure of the active drug to the intestinal lining. We believe TTI-109 strengthens our STAT3-targeted approach by providing a more efficient delivery mechanism for TTI-101 that has the potential to improve tolerability. With a balance sheet extending into the fourth quarter of next year, we remain focused on fully realizing the therapeutic potential of STAT3 inhibition across fibrotic diseases."