On November 8, 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 financial results for the third quarter ended September 30, 2023 and provided a corporate update (Press release, Tempest Therapeutics, NOV 8, 2023, View Source [SID1234637283]).
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"We were extremely pleased to see the pronounced external validation of the new data showing the clear benefit of TPST-1120 combination therapy compared to standard of care in first-line liver cancer," said Stephen Brady, president and chief executive officer of Tempest. "The data have not only improved since the earlier interim analysis, but also include exciting new biomarker results showing that the addition of TPST-1120 effectively rescues the standard of care in PD-L1 negative patients, as well as producing an increased response rate in patients with a b-catenin mutation. Armed with these data and a stronger balance sheet, we are engaged in discussions with potential partners and intend to move TPST-1120 forward in liver cancer, as well as potentially in other indications like kidney cancer given positive signals observed in earlier studies."
Recent Highlights
TPST-1120 (clinical PPARα antagonist): Reported data demonstrating superiority of TPST-1120 across multiple study endpoints in first-line hepatocellular carcinoma. The ongoing randomized trial is evaluating TPST-1120 combined with the standard-of-care regimen of atezolizumab and bevacizumab compared to standard of care alone. Data from 40 patients randomized to the TPST-1120 arm and 30 patients randomized to the control arm, with a median follow-up of 9.2 and 9.9 months, respectively, showed:
Confirmed objective response rate ("cORR" or "confirmed ORR") of 30% for the TPST-1120 triplet arm (an increase from 17% in the earlier interim analysis), as compared to 13.3% for the atezolizumab + bevacizumab control arm; duration of response ("DoR") not yet reached.
Hazard ratio favors the TPST-1120 arm for key survival endpoints
Progression free survival ("PFS"): median PFS of 7 mo (5.6 mo, 13.8 mo) for TPST-1120 arm versus 4.27 mo (2.8 mo, 7.3 mo) for the control arm; HR of 0.7 favors TPST-1120 arm and is not yet mature
Overall survival ("OS"): median OS not reached for the TPST-1120 arm (10.84 mo, NE) versus 15.1 mo (7.49 mo, NE) for the control arm; HR 0.59 favors TPST-1120 arm and is not yet mature
40% of the patients in the TPST-1120 arm were on treatment (16/40) compared to 16.7% in the atezolizumab + bevacizumab control arm (5/30)
72.5% of the patients on the TPST-1120 arm were on study (29/40), compared to 46.7% on the atezolizumab + bevacizumab control arm (14/30)
TPST-1120 remains well tolerated, with safety data comparable between the two arms
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): Continued enrollment of an endometrial cancer-specific arm investigating the two highest doses of TPST-1495 in combination with pembrolizumab.
Stockholder Rights Plan: Adopted a limited duration stockholder rights plan on October 10, 2023 to enable all Tempest stockholders to realize the long-term value of their investment. The rights plan is intended to reduce the likelihood that any person or group gains control of Tempest through open market accumulation without paying stockholders an appropriate control premium or without providing the Board sufficient time to make informed judgments and take actions that are in the best interests of all stockholders.
Potential Future Milestones
TPST-1120 (clinical PPARα antagonist): Plan to advance TPST-1120 into a registrational study in first-line liver cancer patients, likely in connection with a partnership.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): Expect to report data from the 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): Plan to advance new proprietary small molecule series TREX1 inhibitors generated through insights resulting from human TREX1-inhibitor co-crystal structures with the goal to select a lead or development candidate by the end of 2023 or early 2024.
Interim Cash Guidance
As of November 7, 2023, preliminary cash and cash equivalents were $32.8 million, which reflects $23.9 million of net proceeds raised pursuant to the Company’s at-the-market (ATM) program. The results for the quarter-to-date period are preliminary, unaudited and are not necessarily indicative of the results that may be expected for the full quarter or year ending December 31, 2023.
New capital plus the cash and cash equivalents as of the end of the third quarter of 2023 extends the Company’s cash runway into 2025.
Financial Results
Third Quarter 2023
Cash and cash equivalents at the end of the third quarter were $11.1 million, compared to $31.2 million on December 31, 2022.
Net loss and net loss per share for the quarter ended September 30, 2023 were $6.8 million and $0.48, respectively, compared to $8.9 million and $0.66, respectively, for the same period in 2022.
Research and development expenses for the quarter ended September 30, 2023 were $4.2 million compared to $6.0 million for the same period in 2022. The $1.8 million decrease was primarily due to a decrease in costs incurred from contract research organizations and third-party vendors.
General and administrative expenses for the quarter ended September 30, 2023 were $2.4 million compared to $2.8 million for the same period in 2022. The decrease was primarily due to a decrease in consulting and professional expenses and personnel costs.
Year-to-Date
Net cash used in operations for the nine months ended September 30, 2023 was $21.2 million.
Net loss and net loss per share for the nine months ended September 30, 2023 were $22.0 million and $1.57, respectively, compared to $26.6 million and $2.46, respectively, for the same period in 2022.
Research and development expenses for the nine months ended September 30, 2023 were $13.3 million compared to $16.7 million for the same period in 2022. The $3.4 million decrease was primarily due to a decrease in costs incurred from contract research organizations and third-party vendors, partially offset by an increase in facilities expenses.
General and administrative expenses for the nine months ended September 30, 2023 were $8.3 million compared to $9.0 million for the same period in 2022. The $0.7 million decrease was primarily due to a decrease in consulting and professional expenses.