Tempest Therapeutics (TPST) Earnings Call Presentation

Amezalpat (TPST-1120) in HCC - Amezalpat randomized Phase 2 data in first-line HCC showed superiority to the Standard of Care (SoC) arm[6] - Overall Survival (OS) data revealed a six-month improvement with a stable hazard ratio of 0.65 compared to the control arm[6, 32, 35, 58] - Confirmed Objective Response Rate (ORR) in the ITT population was 30% in the Amezalpat + atezolizumab + bevacizumab arm compared to 13.3% in the atezolizumab + bevacizumab arm[32] - In PD-L1 negative patients, the confirmed ORR was 27% in the Amezalpat arm versus 7% in the SoC arm[32] - In patients with β-catenin mutations, the confirmed ORR in the Amezalpat arm was 43% with 100% Disease Control Rate (DCR)[32] Clinical Development and Regulatory - The FDA and EMA have agreed on a Phase 3 plan for Amezalpat[4, 48] - A pivotal Phase 3 study is designed with over 700 subjects and a 1:1 randomization[49] - The Phase 3 study has a critical hazard ratio of <0.805 for primary efficacy and <0.729 for early efficacy[49] - FDA granted Orphan Drug Designation in December 2024 and Fast Track Designation in January 2025[52] Market Opportunity - First-Line HCC is a large market, with 234,785 treated cases across the US, EU5, and China[54]