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Dec 31, 2023
Tempest Q4 2023 Earnings Report
Tempest reported year-end financial results and provided a business update.
Key Takeaways
Tempest Therapeutics reported positive data for TPST-1120 in liver cancer and is preparing for a pivotal Phase 3 trial. The company ended the year with $39.2 million in cash and cash equivalents.
Announced positive randomized first-line HCC data showing superiority of TPST-1120 combination therapy across multiple study endpoints compared to standard of care.
Reported new biomarker data in two important subpopulations, PD-L1 negative and b-catenin mutant patients, consistent with MoA of TPST-1120.
Preparing to move TPST-1120 into a pivotal Phase 3 trial in HCC and TPST-1495 into a Phase 2 in FAP.
Tempest expected to have sufficient resources to fund operations into the second quarter of 2025.
Forward Guidance
Tempest plans to advance TPST-1120 into a registrational study in first-line liver cancer patients, subject to obtaining feedback from the FDA. Expect to report data from the combination arm at the two highest TPST-1495 doses in patients with advanced endometrial cancer in 2024.
Positive Outlook
- Expect to announce updated data from the ongoing randomized study in first-line liver cancer patients in 2024.
- Plan to advance TPST-1120 into a registrational study in first-line liver cancer patients, subject to obtaining feedback from the FDA.
- Plan to advance TPST-1495 into a Phase 2 study in patients with Familial Adenomatous Polyposis (“FAP”) under the auspices of the Cancer Prevention Clinical Trials Network and funded by the National Cancer Institute (“NCI”) Division of Cancer Prevention in 2024, subject to final approval of NCI.
- Expect to report data from the combination arm at the two highest TPST-1495 doses in patients with advanced endometrial cancer in 2024.
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