Earnings release
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TERNS PHARMACEUTICALS Terns Pharmaceuticals Reports Second Quarter 2021 Financial Results and Corporate Highlights August 16 , 2021 • Top - line data from ongoing Phase 1 proof of concept clinical trial of TERN - 501 expected in 4Q 2021 • Top - line data readout from Part 1 of ongoing AVIATION Trial of TERN - 201 expected in 1H 2022 • Cash and equivalents of $ 185.1 million provides runway into 2024 FOSTER CITY , Calif . , Aug. 16 , 2021 ( GLOBE NEWSWIRE ) -- Terns Pharmaceuticals , Inc. ( " Terns " or the " Company " ) ( Nasdaq : TERN ) , a clinical - stage biopharmaceutical company developing a portfolio of small - molecule single - agent and combination therapy candidates for the treatment of non - alcoholic steatohepatitis ( NASH ) and other chronic liver diseases , today reported financial results for the second quarter ended June 30 , 2021 and corporate highlights . " We are pleased to report significant progress across our clinical programs this quarter marked by several important achievements , including initiations of our Phase 1b AVIATION Trial of TERN - 201 and the multiple ascending dose ( MAD ) cohort of our TERN - 501 Phase 1 trial , as well as positive top - line data from our Phase 2a LIFT Study of TERN - 101 , " said Senthil Sundaram , Chief Executive Officer at Terns . “ These milestones highlight our commitment to rapidly advance our broad NASH pipeline . We look forward to proof of concept data for TERN - 501 later this year and for TERN - 201 in 2022. " Recent Developments and Anticipated Upcoming Milestones TERN - 501 : Thyroid hormone receptor - beta ( THR - B ) agonist • Initiated 14 - day multiple ascending dose ( MAD ) portion of Phase 1 trial in June 2021 • Top - line , proof of concept data readout expected in 4Q 2021 , including : • Pharmacodynamic markers of THR - ẞ engagement in the liver linked to NASH efficacy , including sex hormone binding globulin ( SHBG ) and low - density lipoprotein ( LDL ) cholesterol o Indicators of pharmacokinetic stability 。 Safety and tolerability • Received Fast Track Designation ( FTD ) from the U.S. FDA in June 2021 • Provides eligibility for more frequent FDA interactions , accelerated approval and priority review • TERN - 501 is Terns ' third development - stage compound with FTD for the treatment of NASH TERN - 201 : Vascular adhesion protein - 1 ( VAP - 1 ) inhibitor • Initiated 12 - week Phase 1b AVIATION Trial in NASH in June 2021 • Top - line results from Part 1 of AVIATION Trial expected in 1H 2022 , including : o Key efficacy readout in corrected T1 ( CT1 ) , an imaging marker of liver inflammation and fibrosis linked to clinical outcomes • Safety , tolerability and plasma VAP - 1 activity TERN - 101 : Liver - distributed farnesoid X receptor ( FXR ) agonist • Reported positive top - line data from 12 - week Phase 2a LIFT clinical trial in NASH in June 2021 , demonstrating three firsts : • First FXR agonist trial to demonstrate no discontinuations due to adverse events , including pruritus • First 12 - week placebo - controlled trial of an FXR agonist in NASH to show significant improvements in cT1 , an imaging marker of liver inflammation and fibrosis linked to clinical outcomes • First FXR agonist planned to be studied in combination with a THR - ẞ agonist ( TERN - 501 ) • Phase 1 data accepted for publication in Clinical Pharmacology in Drug Development GLP1 - R : Oral , small - molecule glucagon - like peptide - 1 ( GLP1 ) receptor agonist • Nomination of final candidate expected in 2H 2021 Second Quarter Financial Results • Cash Position : As of June 30 , 2021 , cash , cash equivalents and marketable securities were $ 185.1 million as compared with $ 74.9 million as of December 31 , 2020. Based on its current operating plan , Terns expects these funds will be