Tvardi Therapeutics (TVRD) investor relations material

Executive summary

• Focused on developing oral STAT3 inhibitors (TTI-101, TTI-109) for inflammatory and proliferative diseases; TTI-101 in Phase 1b/2 for HCC, TTI-109 completed Phase 1 with positive results and selected for ulcerative colitis (UC) as initial indication.

• Reported topline results for next-generation STAT3 inhibitor TTI-109 in healthy volunteers, confirming prodrug design, improved tolerability, and reductions in disease-relevant immune cell populations.

• Progressed clinical development of STAT3 inhibitors, with TTI-109 showing promising immunomodulatory effects even in healthy volunteers.

• Net loss of $6.5M for Q2 2026 and $13.3M for the six months ended June 30, 2026; accumulated deficit reached $123.7M.

• No product revenue to date; substantial doubt exists about ability to continue as a going concern without additional funding.

Financial highlights

• Cash and cash equivalents were $15.8M as of June 30, 2026, down from $20.7M at year-end 2025.

• Research and development expenses for Q2 2026 were $4.0M, down from $5.8M in Q2 2025, mainly due to lower IPF trial costs and higher TTI-109 spending.

• General and administrative expenses were $2.6M for Q2 2026, down from $3.1M in Q2 2025, primarily due to lower professional fees post-merger.

• No revenue recognized; interest income was $0.2M for Q2 2026.

• Net loss for Q2 2026 was $6.5M, compared to net income of $4.2M in Q2 2025, which included a $12.7M non-cash gain from convertible notes.

Outlook and guidance

• Expects continued significant operating losses as investment in R&D continues; will require additional funding to support operations and clinical programs.

• Topline data for TTI-101 in HCC expected in Q4 2026; further development of TTI-109 in UC contingent on IND clearance and funding.

• KOL webinar on TTI-109 in UC scheduled for August 19, 2026.

• Clinical trial initiation for TTI-109 in UC planned for 2027, pending IND clearance and additional funding.

• Current cash runway expected to fund operations through HCC topline readout into Q3 2027; further advancement of TTI-109 will require more funding.