Tvardi Therapeutics (TVRD) Q1 2025 earnings summary

Executive summary

• Completed merger between Cara Therapeutics and Tvardi Therapeutics on April 15, 2025; Cara changed its name to Tvardi Therapeutics, Inc., and operations now focus on Tvardi's STAT3 inhibitor pipeline.

• Tvardi is a clinical-stage biopharmaceutical company developing oral STAT3 inhibitors for fibrosis-driven diseases, with lead candidate TTI-101 in Phase 2 trials for IPF and HCC; TTI-109 IND submission expected in H1 2025.

• Nasdaq listing increases visibility and potential access to capital.

• Approximately 9.4 million shares outstanding post-merger; pre-merger Cara equity holders own 15.4%, Tvardi equity holders 72.0%, and former convertible note holders 12.5% of the combined company.

• Cash position, including $23.8M from Cara and $28.3M from a December 2024 private placement, expected to fund operations into 2H 2026.

Financial highlights

• For Q1 2025, total revenue was $2.6M, up 20% year-over-year; collaborative revenue rose 52% to $1.2M, other revenue (non-cash royalties) increased 112% to $1.3M.

• Net loss for Q1 2025 was $4.9M, a significant improvement from $30.7M net loss in Q1 2024, primarily due to discontinued clinical programs and reduced R&D and G&A expenses.

• R&D expenses dropped 99% to $0.3M; G&A expenses decreased 32% to $4.6M; no restructuring expenses in Q1 2025 versus $2.4M in Q1 2024.

• Cash, cash equivalents, and short-term investments at closing anticipated to be sufficient to fund operations into the second half of 2026.

• As of April 30, 2025, combined company had $45.7M in cash and short-term investments.

Outlook and guidance

• Tvardi expects to report unblinded Phase 2 IPF data in H2 2025 and preliminary topline Phase 1b/2 HCC data in H1 2026.

• IND submission for second clinical candidate, TTI-109, planned for H1 2025.

• Substantial additional funding may be required to finance ongoing and planned clinical trials; company plans to seek capital through equity, debt, or strategic partnerships.

• Management has concluded that substantial doubt exists about the company's ability to continue as a going concern due to current liquidity and funding needs.