Tempest Therapeutics (TPST) Jefferies Global Healthcare Conference summary

Company overview and portfolio

• Oncology-focused with a diversified pipeline from early research to late-stage clinical programs.

• Two lead clinical assets: TPST-1120 (amezalpat, PPARα antagonist) and TPST-1495 (dual EP2/EP4 antagonist).

• All programs originated internally, except one in-licensed fibroblast program.

• Focus on novel targets with potential for significant impact in cancer treatment.

TPST-1120 (amezalpat) program highlights

• TPST-1120 is a PPARα antagonist with dual mechanism: direct tumor action and immune modulation.

• Strong preclinical and clinical data in HCC, RCC, and CCA; most advanced in first-line liver cancer.

• Phase II trial (in partnership with Roche) showed 30% ORR vs. 13% for control, with a 0.59 hazard ratio for OS.

• Efficacy consistent across PD-L1 status and enhanced in beta-catenin mutant HCC patients.

• Safety profile is favorable, with manageable toxicity and potential commercial advantage as an oral therapy.

Phase III plans and study design

• Phase III in first-line HCC planned to start late this year or early next, pending FDA feedback.

• Study will enroll ~700 patients globally, focusing on Asia (China, Japan) for key recruitment.

• Design mirrors successful phase II, with OS as the primary endpoint and powered for high-performing control arm.

• Strong investigator enthusiasm and CRO interest, with selection based on global capabilities and partnership fit.

• Decision to run independently or partner will depend on OS data and capital market conditions.