Tempest Therapeutics (TPST) Piper Sandler 36th Annual Healthcare Conference summary

Key scientific and clinical insights

• Amezalpat targets PPAR-alpha, inhibiting fat metabolism crucial for tumor and immune suppressor cell growth in liver cancer.

• Combination with Tecentriq and Avastin in first-line liver cancer improved all efficacy endpoints, including doubling objective response rate and extending median overall survival by six months.

• Safety profile of the triplet regimen was consistent and manageable, with adverse events similar to standard of care.

• Efficacy was observed across PD-L1 negative and beta-catenin mutated subpopulations, with no need for companion diagnostics.

• Oral administration and ease of use were highlighted as additional advantages.

Phase III trial design and strategy

• Phase III will closely mirror the successful Phase II design, expanding patient numbers for statistical significance.

• The trial is global, randomized against Tecentriq and Avastin, and includes early efficacy and futility analyses.

• Enrollment is expected to complete in 24 months, with primary data 12 months after last patient in; early efficacy analysis could shorten the timeline.

• Real-world performance of standard of care may further accelerate study completion.

• Financing options for Phase III include capital markets, business development, and royalty financing, with regional deals in Asia considered due to large patient populations.

Pipeline and future development

• Signals of activity in renal cell carcinoma and cholangiocarcinoma suggest potential for expansion beyond liver cancer.

• Focus remains on liver cancer, but first-line renal cancer is a future target.

• TPST-1495 is in Phase I for endometrial cancer and will enter an NCI-funded Phase II for FAP syndrome, providing non-dilutive funding.

• The FAP study will use established endpoints and could lead to pivotal trials if proof of concept is achieved.

• Long-term goal is to move TPST-1495 into pre-colectomy FAP patients.