On November 15, 2021 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), reported financial results for the third quarter ended September 30, 2021 and corporate highlights (Press release, Terns Pharmaceuticals, NOV 15, 2021, View Source [SID1234595605]).

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"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-β 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-β) 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-β engagement linked to NASH histologic efficacy
TERN-501 was generally safe and well-tolerated with a predictable pharmacokinetic (PK) profile with low variability
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-β 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:
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
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 all dose groups
TERN-101 was overall safe and well-tolerated at all doses studied with no discontinuations due to adverse events, including pruritus
In 5 and 10 mg groups of TERN-101, no differences from placebo in LDL cholesterol and high-density lipoprotein (HDL) cholesterol percentage change from baseline to Week 12 were observed
GLP1-R: Oral, small-molecule glucagon-like peptide-1 (GLP1) receptor agonist

Driven by computational interaction mapping, chemical synthesis and in vitro characterization of approximately 100 GLP-1R agonist compounds; lead candidates currently undergoing higher species in vivo profiling
Synthetic GLP-1 peptides have been approved for indication such as diabetes and obesity, which are conditions often accompanying NASH
Development candidate anticipated to be designated as TERN-601 in 4Q 2021
Key Appointments

Ann E. Taylor, M.D. joined the Board of Directors in September 2021, bringing more than 35 years of experience in drug development, having served most recently as chief medical officer of AstraZeneca plc
Pamela Danagher joined Terns as vice president and head of regulatory affairs in August 2021, bringing more than 20 years of experience in the pharmaceutical and biotechnology sectors
Third Quarter Financial Results

Cash Position: As of September 30, 2021, cash, cash equivalents and marketable securities were $177.2 million as compared with $74.9 million as of December 31, 2020. Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2024.
Research and Development (R&D) Expenses: R&D expenses were $7.2 million for the quarter ended September 30, 2021, as compared with $5.4 million for the quarter ended September 30, 2020
General and Administrative (G&A) Expenses: G&A expenses were $4.7 million for the quarter ended September 30, 2021, as compared with $3.3 million for the quarter ended September 30, 2020
Net Loss: Net loss was $11.8 million for the quarter ended September 30, 2021, as compared with $11.6 million for the quarter ended September 30, 2020