On May 10, 2023 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-classi therapeutics that combine both targeted and immune-mediated mechanisms, reported its financial results for the quarter ended March 31, 2023 and provided a corporate update (Press release, Tempest Therapeutics, MAY 10, 2023, View Source [SID1234631402]).
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"The first few months of 2023 set the pace for what we believe will be a transformative year for Tempest," said Stephen Brady, chief executive officer of Tempest. "Recently, we announced exciting early data showing that TPST-1120, the company’s PPAR⍺ antagonist, combined with standard of care in first-line HCC patients demonstrated clinically meaningful improvement in multiple categories, including RECIST responses, over standard of care alone in an ongoing global randomized Phase 1b/2 study. Additionally, at AACR (Free AACR Whitepaper), we presented data highlighting new translational biomarker findings for TPST-1120, as well as the first-of-its-kind co-crystal structures of human TREX1 enzyme and a TREX1 inhibitor, which we believe is an important step forward towards systemic modulation of the STING pathway. We are excited to continue this momentum with multiple potential catalysts this year and in 2024, including more later-stage and biomarker data from the HCC study with TPST-1120."
Recent Highlights
TPST-1120 (clinical PPARα antagonist): (i) presented new biomarker data from Phase 1 patients at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting and Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2023 Spring Scientific Meeting; (ii) disclosed the completion of enrollment in the global randomized first-line Phase 1b/2 study in patients with hepatocellular carcinoma (HCC), under a collaboration with F. Hoffmann La Roche (Roche); and (iii) announced positive early results from the randomized HCC study, demonstrating clinically meaningful improvements in multiple categories and a favorable safety profile when combined with the standard-of-care regimen of atezolizumab and bevacizumab, compared head-to-head to standard-of-care alone, including:
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);
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; and
80% (32/40) of the TPST-1120 arm patients are on study vs. 50% (15/30) in the control.ii
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) continued enrollment of a study evaluating combination dose and schedule optimization with the anti-PD-1 checkpoint inhibitor, pembrolizumab; and (ii) enrolled first patient in an endometrial cancer-specific arm investigating the two highest doses of TPST-1495 in combination with pembrolizumab.
TREX1 Inhibitor (preclinical tumor-selective STING pathway activator): presented data, including human TREX1 enzyme—TREX1 inhibitor X-ray co-crystal structures, at the 2023 AACR (Free AACR Whitepaper) Annual Meeting.
Potential Upcoming Milestones
TPST-1120 (clinical PPARα antagonist): we expect to receive updated data from the ongoing global randomized first-line Phase 1b/2 study in patients with HCC from Roche.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): we plan to report data from (i) 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) (Free ASCO Whitepaper) Annual Meeting, and (ii) a separate combination arm at the two highest TPST-1495 doses in patients with advanced endometrial cancer in 2024.
TREX1 Inhibitor (preclinical tumor-selective STING pathway activator): we expect to advance new proprietary small molecule series TREX1 inhibitors generated through insights resulting from human TREX1-inhibitor co-crystal structures.
Financial Results
First Quarter 2023
Tempest ended the first quarter with $22.9 million in cash and cash equivalents, compared to $31.2 million on December 31, 2022.
Net loss and net loss per share for the quarter ended March 31, 2023 were $7.6 million and $0.55, respectively, compared to $8.5 million and $1.18, respectively, for the same period in 2022.
Research and development expenses for the quarter ended March 31, 2023 were $4.7 million compared to $5.1 million for the same period in 2022. The decrease was primarily due to a decrease in research and development costs incurred from contract research organizations and third-party vendors, offset by an increase in personnel costs, as well as facilities expenses.
General and administrative expenses for the quarter ended March 31, 2023 were $2.9 million compared to $3.1 million for the same period in 2022. The decrease was primarily due to a decrease in consulting and professional services.
Based on the current cash position and operating plan, Tempest expects to have sufficient resources to fund operations through the second quarter of 2024.