Loading...
•
Mar 31, 2023
Tempest Q1 2023 Earnings Report
Reported financial results for the first quarter of 2023 and provided a corporate update.
Key Takeaways
Tempest Therapeutics reported a net loss of $7.6 million, with cash and cash equivalents totaling $22.9 million at the end of the quarter. The company highlighted positive early data from its TPST-1120 study in HCC patients and presented new data on its TREX1 inhibitor program.
Reported unconfirmed responses of 30% for the TPST-1120 triplet arm (12/40) vs. 17.2% for the active control arm (5/29), demonstrating a 74.4% relative improvement in objective response rate (ORR).
Reported confirmed responses of 17.5% for the TPST-1120 triplet arm (7/40) vs. 10.3% for the active control arm (3/29), demonstrating a 69.9% relative improvement in confirmed ORR.
47.5% (19/40) of the TPST-1120 arm patients are on treatment vs. 23.3% (7/30) in the control arm.
Ended the quarter with $22.9 million in cash and cash equivalents.
Tempest
Tempest
Forward Guidance
Tempest anticipates updated data from the TPST-1120 HCC study from Roche and plans to report data from the TPST-1495 trial at ASCO 2023, with further data on the endometrial cancer arm in 2024. The company also expects to advance its TREX1 inhibitor program.
Positive Outlook
- Expect to receive updated data from the ongoing global randomized first-line Phase 1b/2 study in patients with HCC from Roche for TPST-1120.
- Plan to report data from the Phase 1 dose and schedule optimization trial studying monotherapy and combination therapy with an anti-PD1 therapy, pembrolizumab, at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting for TPST-1495.
- Plan to report data from a separate combination arm at the two highest TPST-1495 doses in patients with advanced endometrial cancer in 2024.
- Expect to advance new proprietary small molecule series TREX1 inhibitors generated through insights resulting from human TREX1-inhibitor co-crystal structures.
- Based on the current cash position and operating plan, Tempest expects to have sufficient resources to fund operations through the second quarter of 2024.
Challenges Ahead
- Unexpected safety or efficacy data observed during preclinical or clinical trials.
- Clinical trial site activation or enrollment rates that are lower than expected.
- Changes in expected or existing competition.
- Changes in the regulatory environment.
- Unexpected litigation or other disputes.