Tvardi Therapeutics (TVRD) investor relations material

Executive summary

• Focused on developing oral STAT3 inhibitors for inflammatory and proliferative diseases, with lead candidates TTI-101 (in Phase 1b/2 for HCC) and TTI-109 (in Phase 1 for healthy volunteers); topline results for TTI-109 expected June 2026 and TTI-101 HCC data in 2H 2026.

• Reported topline data from a Phase 2 trial in IPF for TTI-101 did not meet primary goals, but subset analysis showed promising exploratory biomarker reductions, including a 9.4% reduction in fibrosis score versus 2.4% for placebo and a 4.5-fold greater decline in IL-6 levels.

• Merger with Cara Therapeutics completed in April 2025, resulting in a new public entity, recapitalization, and conversion of preferred stock and $28.3 million in convertible notes to common stock.

• Interim findings from the REVERT LIVER CANCER trial demonstrated clinically meaningful activity for TTI-109, which is positioned as a next-generation STAT3 inhibitor with potential for improved tolerability and broader application.

• Cash runway projected to fund operations through clinical readouts and into Q4 2026.

Financial highlights

• Net loss for Q1 2026 was $6.8 million, a 29% improvement from $9.6 million in Q1 2025.

• Operating expenses increased 62% year-over-year to $7.1 million, driven by higher R&D and G&A costs.

• R&D expenses for Q1 2026 were $4.9 million, up from $3.1 million in Q1 2025, mainly due to higher TTI-109 development costs.

• G&A expenses rose to $2.1 million from $1.2 million year-over-year, driven by higher personnel and professional fees.

• Cash, cash equivalents, and short-term investments totaled $25.0 million as of March 31, 2026, down from $30.8 million at year-end 2025.

Outlook and guidance

• Expects continued significant operating losses and negative cash flows as R&D investment continues.

• Substantial doubt exists about ability to continue as a going concern without additional funding.

• Plans to seek additional capital through equity, debt, or strategic partnerships; filed a $200 million shelf registration in May 2026.

• Topline data for TTI-109 healthy volunteer study and clinical development strategy expected in June 2026; TTI-101 Phase 1b/2 HCC topline data anticipated in 2H 2026.

• Current cash runway expected to support operations through clinical milestones and into Q4 2026.