Earnings release
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Tempest Reports Second Quarter 2021 Financial Results and Provides Corporate Highlights August 12 , 2021 TEMPEST THERAPEUTICS • Closed merger transaction resulting in public listing ( TPST ) • Closed $ 30M PIPE , extending runway into Q1'23 Advancing TPST - 1495 and TPST - 1120 into targeted patient populations • Advanced TREX - 1 program to potent lead series with in vivo efficacy SOUTH SAN FRANCISCO , Calif . , Aug. 12 , 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 second quarter ended June 30 , 2021 . " The second quarter of 2021 was an exciting period as Tempest became a public company and the team drove progress in all three of our novel programs , " said Steve Brady , chief executive officer of Tempest . " We look forward to the planned opening of the TPST - 1120 randomized study in first line hepatocellular carcinoma in collaboration with Roche and the first combination study of TPST - 1495 , and remain focused on delivering potentially value - creating milestones over the next year and beyond . " Recent Highlights • Public Company Transition : successfully closed merger and concurrent PIPE financing , allowing Tempest to become a public company listed on the Nasdaq Capital Market , and extending runway into 2023 through multiple potential catalysts . • TPST - 1495 ( clinical dual EP2 / 4 prostaglandin receptor antagonist ) : continued enrollment in monotherapy dose optimization towards recommended Phase 2 dose ( " RP2D " ) . • TPST - 1120 ( clinical PPARa antagonist ) : ( i ) completed monotherapy dose escalation and selected 600mg BID as RP2D ; ( ii ) observed stable disease ( " SD " ) in 50 % of the monotherapy - treated patients , including prolonged SD in patients with refractory cholangiocarcinoma ; and ( iii ) observed a deep , confirmed partial response in a patient with checkpoint inhibitor refractory fourth line renal cell carcinoma in the combination study with nivolumab ( - > 60 % by RECIST 1.1 , durable through 4 scans and ongoing ) . • TREX - 1 Inhibitor ( preclinical , tumor - selective STING pathway activator ) : ( i ) progressed lead series to picomolar IC50 potency in biochemical assays ; and ( ii ) demonstrated significant proof of concept in a mouse tumor model with systemic delivery of a lead series molecule . • Board of Directors : Christine Pellizzari , J.D. , Geoff Nichol , M.B. , Ch.B. , M.B.A. , and Ronit Simantov , M.D. , joined the Board of Directors , bringing deeper financial , legal , and clinical development expertise to Tempest . 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 an 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 PPARα antagonist ) : ( i ) identification of RP2D of TPST - 1120 in combination with nivolumab expected prior to the end of 2021 ; and ( ii ) commencement of first line randomized Phase 1b / 2 study in hepatocellular carcinoma patients , under a collaboration with F. Hoffman La Roche , expected within the third quarter . • TREX - 1 Inhibitor ( preclinical tumor - selective STING pathway activator ) : planned selection of development candidate in the first half of 2022 . Financial Results Second Quarter • Tempest ended the second quarter of 2021 with $ 68.5 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 second quarter of 2021 were $ 7.1 million and $ 7.63 , respectively , compared to $ 5.2 million and $ 11.42 , respectively , for the second 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 second quarter of 2021 were $ 4.2 million , compared to $ 4.1 million for the