Tvardi Therapeutics (TVRD) Q3 2025 earnings summary

Executive summary

• Completed a reverse merger with Cara Therapeutics in April 2025, resulting in a new public entity and $23.9 million in net assets acquired.

• Lead candidate TTI-101 in Phase 2 for HCC, with topline data expected in H1 2026; Phase 2 IPF trial did not meet goals, with high discontinuation rates due to GI adverse events and further analyses ongoing.

• TTI-109, a prodrug of TTI-101, entered Phase 1 in 2025 to address tolerability issues; healthy volunteer study initiated with results anticipated in H1 2026.

• No revenue generated; operations funded by equity, convertible notes, and merger proceeds.

• Cash runway projected to fund operations into Q4 2026.

Financial highlights

• Net loss of $5.5 million for Q3 2025 and $10.9 million for the nine months ended September 30, 2025, compared to $5.5 million and $16.7 million for the same periods in 2024.

• Cash, cash equivalents, and short-term investments totaled $36.5 million as of September 30, 2025.

• Accumulated deficit reached $103.2 million as of September 30, 2025.

• Operating expenses increased 10.7% year-over-year for the nine-month period, driven by higher G&A costs post-merger.

• $7.8 million net gain from fair value changes in convertible notes recognized in 2025.

Outlook and guidance

• Topline data from ongoing REVERT Liver Cancer Phase 1b/2 trial of TTI-101 and healthy volunteer study of TTI-109 expected in H1 2026.

• Substantial doubt exists about the ability to continue as a going concern; additional funding required to support operations and clinical programs.

• Plans to seek further capital through equity, debt, or strategic partnerships.

• Expects continued operating losses as R&D investment persists.

• Current cash position expected to fund operations into Q4 2026.