Tempest Therapeutics, Inc. announced new positive data from the ongoing global randomized Phase 1b/2 clinical study in which amezalpat (TPST-1120), Tempest?s PPAR? antagonist, delivered a six-month improvement in median overall survival (?OS?) advantage when combined with atezolizumab and bevacizumab in a comparison to atezolizumab and bevacizumab alone in the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma (?HCC?). At the cutoff date of February 14, 2024, the new data from 40 patients randomized to the amezalpat arm and 30 patients randomized to the control arm show: 21 month median OS for the amezalpat arm versus 15 month for the control arm, a six-month survival advantage; 20/40 patients remain in survival follow up in the amezalpat arm, compared to 9/30 patients in the control arm; 0.65 hazard ratio (?HR?) for OS, revealing a stable HR since the top-line analysis 10 months earlier when the HR was 0.59; Manageable safety profile consistent with Phase 1 data.

The earlier top-line data analysis, dated April 20, 2023, had a median follow up of 9.2 and 9.9 months for the amezalpat and control arms, respectively, and showed: Confirmed objective response rate (?cORR? or ?confirmed ORR?) of 30% for the amezalpat arm versus 13.3% for the control arm; Biomarker subpopulation findings were consistent with the mechanism of action of amezalpat; Patients with b-catenin activating mutations (21% in this study (n=7)) showed a cORR of 43% and a disease control rate (?DCR?) of 100% in the amezalpat arm.