Tempest Therapeutics (TPST) H.C. Wainwright 26th Annual Global Investment Conference 2024 summary

Key presentations and announcements

• Tempest Therapeutics presented positive phase 2 data for amezalpat in first-line hepatocellular carcinoma, showing a 35% reduction in risk of death and a six-month improvement in median overall survival compared to standard of care.

• The company received broad FDA agreement on its phase 3 registrational trial design, with plans to initiate the pivotal study early next year.

• Amezalpat demonstrated consistent benefit across all patient subgroups, including those with immune-negative tumors and poor prognostic factors.

• The safety profile of the amezalpat combination was similar to standard of care, with no increase in high-grade or serious adverse events.

• Additional pipeline assets include TPST-1495, set for a phase 2 study in FAP syndrome, and ongoing research into novel cancer targets.

Industry analysis and strategic outlook

• Hepatocellular carcinoma remains a major unmet need globally, with over 230,000 patients treated annually in the first-line setting.

• Amezalpat's oral formulation offers potential market advantages in cost and patient preference over intravenous therapies.

• The phase 3 trial is designed to closely replicate the successful phase 2, with increased size and statistical power for regulatory approval.

• Expansion into renal cell carcinoma and cholangiocarcinoma is planned, supported by favorable early data and external funding.

• The company maintains full control and ownership of its assets, positioning itself as a diversified and potentially undervalued player in oncology.

Research highlights and clinical insights

• Amezalpat targets PPAR-alpha, a key regulator of fatty acid oxidation, impacting tumor metabolism, angiogenesis, and immune suppression.

• The drug improved outcomes even in immune-cold tumors, a group typically resistant to immunotherapy.

• Efficacy endpoints, including objective response rate and progression-free survival, favored the amezalpat combination.

• The triplet regimen (amezalpat plus standard of care) showed broad and consistent benefit across all analyzed subgroups.

• Ongoing discovery efforts aim to identify additional novel cancer targets for future clinical development.