Tvardi reports healthy volunteer data for TTI-109, picks ulcerative colitis as lead indication

Tvardi Therapeutics reported second quarter 2026 results on August 14, 2026, along with topline data from a healthy volunteer study of its next-generation STAT3 inhibitor, TTI-109. The company said the study confirmed prodrug design, improved tolerability and pharmacodynamic evidence of STAT3 target engagement.¹ Tvardi reported that TTI-109 produced exposure equivalent to TTI-101 while showing better tolerability, and across the active dose range it reduced immune cell populations, both cellular and antibody-related, that have been linked to how severe ulcerative colitis becomes.¹

Based on these results, Tvardi selected ulcerative colitis (UC) as the initial disease indication for TTI-109, based on its ability to modulate multiple pathogenic pathways downstream of STAT3 simultaneously.¹ The company is scheduled to hold a KOL webinar on the clinical potential of TTI-109 in UC featuring Randy Longman, MD, PhD of Weill Cornell Medicine, on August 19, 2026, at 11:00 a.m. ET.¹

On the pipeline timeline, Tvardi listed fourth quarter 2026 topline data from the TTI-101 Phase 1b/2 hepatocellular carcinoma (HCC) trial, and a 2027 start for a clinical trial of TTI-109 in UC, subject to clearance of an Investigational New Drug (IND) application and additional funding.¹

On finances, research and development expenses fell to $4.0 million for the quarter from $5.8 million a year earlier, which the company attributed to lower spending tied to the TTI-101 program, partly offset by increased spending on developing TTI-109.¹ Net loss was $6.5 million for the quarter, compared with net income of $4.2 million in the same period of 2025, a difference the company linked to a $12.7 million non-cash gain recorded in the prior year from a change in the value of convertible notes that turned into common stock when Tvardi merged with Cara Therapeutics in April 2025.¹ Tvardi reported cash, cash equivalents and short-term investments of $15.8 million as of June 30, 2026, down from $30.8 million at the end of 2025.¹ The company said it expects existing cash to fund operations, as currently planned, through the HCC topline readout into the third quarter of 2027.¹ It added that advancing TTI-109 into UC and additional indications will require additional funding and IND clearance.¹