Tvardi Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Research and development expenses for the three months ended September 30, 2026, were $4.5 million, an increase from $3.6 million in the same period of 2025, driven by higher clinical costs associated with TTI-101.
• General and administrative expenses for the three months ended September 30, 2026, were $1.9 million, a decrease from $2.3 million in the comparable 2025 period, primarily due to lower professional fees.
• Net loss for the three months ended September 30, 2026, was $6.1 million, compared to a net loss of $5.5 million for the three months ended September 30, 2025.
• Basic and diluted net loss per share for the three months ended September 30, 2026, was $(0.48), compared to $(0.59) for the three months ended September 30, 2025.
• Cash and cash equivalents as of September 30, 2026, were $22.3 million, down from $30.8 million in cash, cash equivalents, and short-term investments as of December 31, 2025.
• Total operating expenses for the nine months ended September 30, 2026, were $20.0 million, compared to $19.2 million for the same period in 2025.
• Net loss for the nine months ended September 30, 2026, was $19.4 million, compared to $10.9 million for the nine months ended September 30, 2025.

Guidance and Future Outlook:

• Tvardi anticipates that existing cash and cash equivalents will be sufficient to fund operations into the third quarter of 2027, as currently planned.
• Advancement of TTI-109 into ulcerative colitis (UC) and additional indications remains subject to additional funding and Investigational New Drug (IND) clearance.
• The company expects to report topline data from the Phase 1b/2 REVERT LIVER CANCER study in the early first quarter of 2027.

Business Segments and Product Lines:

• TTI-109 (Ulcerative Colitis): Tvardi is advancing development plans for TTI-109 in UC following positive Phase 1 healthy volunteer results reported in July. The prodrug design confirmed TTI-109 delivers TTI-101-equivalent exposure with improved tolerability and demonstrated reductions in cellular and humoral immune populations correlating with UC disease severity.
• TTI-109 Preclinical Data: New findings published in the International Journal of Molecular Sciences showed TTI-101 achieved colon tissue exposure approximately eightfold higher than plasma, normalized disease-associated gene expression, muted colitis-associated gut microbiome changes, and prevented colon adenocarcinoma formation in a chronic colitis model.
• TTI-101 (Hepatocellular Carcinoma): The ongoing REVERT LIVER CANCER study is evaluating TTI-101 as monotherapy and in combination with established therapies in HCC patients.
• Pipeline Progress: Management confirmed positive Phase 1 results for TTI-109 strengthened confidence in the next-generation STAT3 inhibitor, with plans to initiate clinical trials in UC and potentially other inflammatory bowel diseases in 2027.

Market and Competitive Landscape:

• Tvardi focuses on developing novel, oral, small molecule therapies targeting STAT3 to treat inflammatory and proliferative diseases with significant unmet need.
• STAT3 is identified as a central mediator in signaling pathways driving immune dysregulation, inflammation, and proliferation, as well as a position integral to cancer cell survival and immune evasion.

Risks and Challenges:

• Advancing TTI-109 into UC and other indications is contingent upon IND clearance and the availability of additional funding.
• The company faces risks associated with clinical development and regulatory approval, including potential delays, safety complications, and the inability to replicate preclinical or early clinical trial results in later trials.
• Significant net losses have been incurred since inception, and the company may not be able to obtain additional capital on favorable terms or at all.
• Future results depend on the ability to attract, hire, and retain skilled personnel, protect intellectual property, and rely on third-party manufacturers and research organizations.

Management Commentary and Tone:

• Imran Alibhai, Ph.D., Chief Executive Officer, stated the company continues to make meaningful progress across its pipeline and remains encouraged by previously reported interim results for TTI-101.
• Management expressed confidence in TTI-109's potential while noting that future advancement is subject to funding availability.

Other Key Points:

• Shares issued and outstanding increased to 13,345,956 as of September 30, 2026, from 9,381,344 as of December 31, 2025.
• Short-term investments were $0 as of September 30, 2026, compared to $10.1 million as of December 31, 2025.
• Accumulated deficit increased to $(129.8) million as of September 30, 2026, from $(110.5) million as of December 31, 2025.
• The company is conducting a Phase 1b/2 clinical trial of TTI-101 in hepatocellular carcinoma under NCT05440708.