On March 29, 2022 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-class1 therapeutics that combine both targeted and immune-mediated mechanisms, reported financial results for the year ended December 31, 2021 and provided a corporate update (Press release, Tempest Therapeutics, MAR 29, 2022, View Source [SID1234611109]).

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"We are excited by the numerous achievements the Tempest team made in 2021, including emerging as a public company from a competitive merger process and establishing the collaboration with Roche that moved TPST-1120 into a first-line global, randomized HCC study," said Stephen R. Brady, chief executive officer of Tempest. "This and the broader progress made in the pipeline positions Tempest for a potentially transformative 2022. Our first clinical data presentation planned for ASCO (Free ASCO Whitepaper) in June is the first in a series of planned data releases over the course of the next 12-18 months, including initial ORR data from both our ongoing randomized TPST-1120 study with our partner Roche and the first monotherapy and combination therapy data from TPST-1495, our dual EP2/EP4 antagonist. We are excited about this ongoing positive evolution of Tempest, and we will continue to work to develop what we believe to be is a robust and diversified pipeline of novel cancer programs with the potential to treat a wide range of patients."

1 If approved by the FDA

Recent Highlights

TPST-1120 (clinical PPARα antagonist): (i) completed Phase 1 monotherapy arm and nearing completion of the anti-PD-1 checkpoint inhibitor, nivolumab, combination dose escalation arms, and selected recommended Phase 2 dose ("RP2D"); and (ii) continued enrollment in first-line, randomized global Phase 1b/2 study in patients with hepatocellular carcinoma (HCC), under a collaboration with F. Hoffmann La Roche.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) continued enrollment in a Phase 1 study evaluating monotherapy dose and schedule optimization towards establishing an RP2D; and (ii) commenced enrollment of a study evaluating combination dose and schedule optimization study with the anti-PD-1 checkpoint inhibitor, pembrolizumab.
SITC Presentation: at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting, presented new preclinical efficacy data demonstrating that dual inhibition pf the EP2 and EP4 receptors with TPST-1495 is an optimal approach for targeting the prostaglandin pathway in cancer.
Expansion of Patent Portfolio: the U.S. Patent and Trademark Office issued patents covering composition of matter for our therapeutic product candidate TPST-1495.
Planned Near-Term Milestones

TPST-1120 (clinical PPARα antagonist): (i) if accepted to present, presentation of Phase 1 monotherapy and combination data at ASCO (Free ASCO Whitepaper) 2022; and (ii) reporting of objective response data from the first 40 HCC patients in the first-line randomized study expected by year end or early 2023.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist): (i) selection of monotherapy RP2D expected in the first half of 2022; and (ii) data from Phase 1 monotherapy and combination dose and schedule optimization arms expected by year end or early 2023.
TREX1 Inhibitor (preclinical tumor-selective STING pathway activator): (i) presentation of the first data demonstrating therapeutic benefit in tumor-bearing mice treated with systemically-administered proprietary targeted molecules at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting; and (ii) planned selection of development candidate in the second half of 2022.
Financial Results

Year End 2021

Tempest ended the year 2021 with $51.8 million in cash and cash equivalents, compared to $18.8 million at December 31, 2020. The increase was primarily due to the merger and concurrent PIPE financing, which closed in June 2021.
Net cash used in operations for the year ended December 31, 2021 was $26.0 million.
Net loss and net loss per share for the year ended December 31, 2021 were $28.3 million and $7.47, respectively, compared to $19.2 million and $41.03, respectively, for the same period in 2020.
Research and development expenses for the year ended December 31, 2021 were $17.2 million compared to $14.4 million for the same period in 2020. The $2.8 million increase was primarily attributable to expanded research and development efforts and increased fees for consulting services and compensation expenses.
For the year ended December 31, 2021, general and administrative expenses were $9.8 million compared to $4.9 million for the same period in 2020. The increase of $4.9 million was primarily due to increased fees for audit and tax services and compensation expenses.
Based on current cash position and operating plan, Tempest expects to have sufficient resources to fund operations into the second half of 2023.