Earnings release
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TERNS PHARMACEUTICALS Terns Pharmaceuticals Reports Third Quarter 2021 Financial Results and Corporate Highlights November 15 , 2021 -Top - line data readout from TERN - 201 ( VAP - 1 ) clinical trial in NASH expected in 1Q 2022 -Positive top - line data from TERN - 501 ( THR - ẞ ) demonstrated clinical proof of concept , enabling the planned initiation of NASH trial in 1H 2022 -Multiple abstracts detailing positive clinical data for TERN - 101 and TERN - 501 presented at AASLD 2021 -Cash and equivalents of $ 177 million provides runway into 2024 FOSTER CITY , Calif . , Nov. 15 , 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 to address serious diseases such as non - alcoholic steatohepatitis ( NASH ) , today reported financial results for the third quarter ended September 30 , 2021 and corporate highlights . " Recent positive clinical data for TERN - 101 and TERN - 501 presented at AASLD validate part one of Terns ' strategy , which is demonstrating monotherapy proof of concept . Notably , TERN - 501 produced significant and dose - dependent changes in sex hormone binding globulin ( SHBG ) , a marker of target engagement linked to NASH efficacy , suggesting that it has potential to be a best - in - class THR - ẞ agonist . We look forward to the top - line data readout from the AVIATION Trial of TERN - 201 in the first quarter of 2022 , which could mark our third clinical candidate with promising monotherapy data , " said Senthil Sundaram , chief executive officer at Terns . " I am proud of the quality of execution at Terns and the momentum with which we are advancing our pipeline towards the second part of our strategy : achieving compelling and differentiated efficacy results in studies involving multiple clinically validated mechanisms of action . With this goal in mind , we are excited to move towards the planned initiation in the first half of 2022 of Terns ' first clinical trial in NASH patients including both monotherapy and combination arms of TERN - 101 and TERN - 501 . " Recent Developments and Anticipated Milestones TERN - 201 : Vascular adhesion protein - 1 ( VAP - 1 ) inhibitor • Fully enrolled Part 1 of Phase 1b AVIATION Trial in NASH in September 2021 • Top - line data from AVIATION Part 1 expected in 1Q 2022 , including : • Key efficacy readout in corrected T1 ( CT1 ) levels , an imaging marker of liver inflammation and fibrosis linked to clinical outcomes • Safety , tolerability and plasma VAP - 1 activity TERN - 501 : Thyroid hormone receptor - beta ( THR - B ) agonist • Reported positive top - line data from Phase 1 proof of concept clinical trial in November 2021 , including a presentation at AASLD 2021 demonstrating : • Significant , dose - dependent effects on SHBG , a key pharmacodynamic marker of THR - ẞ engagement linked to NASH histologic efficacy • TERN - 501 was generally safe and well - tolerated with a predictable pharmacokinetic ( PK ) profile with low variability o Significant , dose - dependent reductions in atherogenic lipids including low - density lipoprotein ( LDL ) cholesterol and apolipoprotein B ( Apo - B ) in all TERN - 501 dose groups compared to placebo • The safety , PK and PD results support continued development of TERN - 501 and indicate that it is well - suited for co - formulation with other small molecule NASH agents as an oral , once - daily fixed dose combination • Data support plans to initiate in 1H 2022 Terns ' first NASH trial of a THR - ẞ agonist ( TERN - 501 ) alone and in combination with a farnesoid X receptor ( FXR ) agonist ( TERN - 101 ) TERN - 101 : Liver - distributed FXR agonist • Presented positive data from Phase 2a LIFT clinical trial in NASH at AASLD's The Liver Meeting® Digital Experience 2021 , which demonstrated : o CT1 declined significantly as early as Week 6 with persistent decreases through Week 12 in all TERN - 101 groups compared to placebo , with cT1 changes at Week 6 strongly correlated with changes at Week 12 • TERN - 101 treatment led to study population shifts to cT1 categories associated with lower risk of clinical events in chronic liver disease patients o In 10 and 15 mg groups of TERN - 101 , numerical reductions in alanine aminotransferase ( ALT ) and MRI protein density fat fraction ( MRI - PDFF ) were observed , with significant reductions in gamma glutamyl transferase ( GGT ) in