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Tempest Reports Third Quarter 2021 Financial Results and Provides Corporate Highlights November 10 , 2021 • First patients dosed in first line , randomized , global Phase 1b / 2 hepatocellular carcinoma ( " HCC " ) study of TPST - 1120 combination regimen , in collaboration with F. Hoffmann La Roche TEMPEST THERAPEUTICS • Exclusive rights to novel oncology target in - licensed from the lab of Russell Vance , Ph.D. , at the University of California at Berkeley ( " U.C. Berkeley " ) SOUTH SAN FRANCISCO , Calif . , Nov. 10 , 2021 ( GLOBE NEWSWIRE ) -- Tempest Therapeutics , Inc. ( Nasdaq : TPST ) , a clinical - stage oncology company developing potentially first - in - class therapeutics that combine both targeted and immune - mediated mechanisms , today reported financial results and provided a corporate update for the third quarter ended September 30 , 2021 . " The third quarter of 2021 saw continued execution and progress in our programs , including the opening of a collaborative clinical trial with Roche in first line HCC patients comparing TPST - 1120 in combination with atezolizumab and bevacizumab to the standard of care regimen , atezolizumab and bevacizumab , " said Stephen R. Brady , chief executive officer of Tempest . " In the fourth quarter of this year and the first half of 2022 , we plan to continue this focused approach as our second clinical program , TPST - 1495 , is poised to move into a set of studies that select patients predicated on strong mechanistic rationale , genetically - defined histologies , and a potential mutation - based biomarker . " Recent Highlights ● T - 1495 ( clinical dual EP2 / 4 prostaglandin receptor antagonist ) : continued enrollment in monotherapy towards recommended Phase 2 dose ( " RP2D " ) . • TPST - 1120 ( clinical PPARa antagonist ) : ( i ) after completion of monotherapy dose escalation , continued enrollment in combination dose escalation towards RP2D ; and ( ii ) commencement of first line , randomized global Phase 1b / 2 study in HCC patients , under a collaboration with F. Hoffmann La Roche . optimization • New Drug Discovery Program : entered into an exclusive license with U.C. Berkeley for intellectual property covering a new drug target discovered in the laboratory of Russell Vance , Ph.D. , professor of molecular and cell biology at U.C. Berkeley and a Howard Hughes Medical Institute investigator . • Advisory Board : announced the appointment of Dr. Vance to Tempest's Advisory Board , joining a distinguished roster consisting of Toni Choueiri , M.D. , Benjamin Cravatt , Ph.D. , Raymond DuBois , M.D. , Ph.D. , Jason Luke , M.D. , Drew Pardoll , M.D. , and Peppi Prasit , Ph.D. Planned Near - Term Milestones • TPST - 1495 ( clinical dual EP2 / 4 prostaglandin receptor antagonist ) : ( i ) selection of monotherapy RP2D expected in the first half of 2022 ; ( ii ) commencement of a combination study with anti - PD - 1 checkpoint inhibitor expected prior to the end of 2021 ; and ( iii ) commencement of monotherapy expansion in targeted indications and biomarker - selected patient populations expected in the first half of 2022 . • TPST - 1120 ( clinical PPAR¤ antagonist ) : ( i ) identification of RP2D of TPST - 1120 in combination with nivolumab expected prior to the end of 2021 ; and ( ii ) presentation of Phase 1 monotherapy and combination data in mid 2022 . Financial Results • TREX - 1 Inhibitor ( preclinical tumor - selective STING pathway activator ) : planned selection of development candidate in the first half of 2022 . Third Quarter • Tempest ended the third quarter of 2021 with $ 59.8 million in cash and cash equivalents and short - term restricted cash , compared to $ 18.8 million in December 31 , 2020. The increase was primarily due to the merger and concurrent PIPE , which closed in June 2021 . • Net loss and net loss per share for the third quarter of 2021 were $ 8.1 million and $ 1.21 , respectively , compared to $ 5.4 million and $ 11.22 , respectively , for the third quarter of 2020. The increase was primarily due to an increase in compensation expense and professional fees associated with the merger . • Research and development expenses for the third quarter of 2021 were $ 4.6 million , compared to $ 4.3 million for the same