Tvardi Therapeutics Announces Third Quarter 2026 Results and Provides Business Update

(NASDAQ:TVRD) Tvardi Therapeutics, Inc. reported its financial and operating results for the third quarter ended September 30, 2026, and provided a business update. The company is advancing development plans for TTI-109 in ulcerative colitis (UC), building on positive Phase 1 healthy volunteer results reported in July and the subsequent selection of UC as its initial target indication. Tvardi is preparing to advance TTI-109 into clinical development in UC, subject to clearance of its Investigational New Drug (IND) application and additional funding. Phase 1 results confirmed the prodrug design, with TTI-109 delivering TTI-101-equivalent exposure with improved tolerability and demonstrated reductions in immune populations correlated with UC disease severity, providing pharmacodynamic evidence of STAT3 target engagement. Additional preclinical data published in the International Journal of Molecular Sciences showed that TTI-101 achieved colon tissue exposure approximately eightfold higher than in plasma, normalized disease-associated changes in colon gene expression, muted colitis-associated changes in the gut microbiome, and prevented the formation of colon adenocarcinomas in a preclinical model of chronic colitis. These findings build on prior preclinical studies in which TTI-101 and TTI-109 significantly reduced disease activity across three acute colitis models. The company is also advancing the Phase 1b/2 REVERT LIVER CANCER study evaluating TTI-101 as monotherapy and in combination with established therapies in patients with hepatocellular carcinoma (HCC), with topline data expected early in the first quarter of 2027. Key upcoming milestones include the initiation of a clinical trial of TTI-109 in UC in 2027, subject to IND clearance and additional funding, and the reporting of TTI-101 Phase 1b/2 HCC topline data in early first quarter of 2027. Research and development expenses for the three months ended September 30, 2026, were $4.5 million, compared to $3.6 million for the same period in 2025, primarily due to higher clinical costs associated with TTI-101. General and administrative expenses were $1.9 million for the three months ended September 30, 2026, compared to $2.3 million for the same period in 2025, primarily due to lower professional fees. Net loss for the three months ended September 30, 2026, was $6.1 million, compared to $5.5 million for the same period in 2025. Basic and diluted net loss per share attributable to common stockholders for the three months ended September 30, 2026, were both $(0.48), compared to $(0.59) for the same period in 2025. Cash and cash equivalents as of September 30, 2026, were $22.3 million, compared to $30.8 million as of December 31, 2025. Tvardi anticipates that its existing cash and cash equivalents will be sufficient to fund operations, as currently planned, into the third quarter of 2027. Advancing TTI-109 into UC and additional indications remains subject to additional funding and IND clearance. The company is conducting a Phase 1b/2 clinical trial of TTI-101 in hepatocellular carcinoma (NCT05440708). Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi, commented on the progress across the pipeline and the company's confidence in TTI-109 and TTI-101.