On August 16, 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 for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases, reported financial results for the second quarter ended June 30, 2021 and corporate highlights (Press release, Terns Pharmaceuticals, AUG 16, 2021, View Source [SID1234586635]).

"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."

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Recent Developments and Anticipated Upcoming Milestones

TERN-501: Thyroid hormone receptor-beta (THR-β) 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-β engagement in the liver linked to NASH efficacy, including sex hormone binding globulin (SHBG) and low-density lipoprotein (LDL) cholesterol
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:
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-β 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 sufficient to support its planned operating expenses into 2024
Research and Development (R&D) Expenses: R&D expenses were $6.0 million for the quarter ended June 30, 2021, as compared with $7.6 million for the quarter ended June 30, 2020
General and Administrative (G&A) Expenses: G&A expenses were $4.9 million for the quarter ended June 30, 2021, as compared with $2.5 million for the quarter ended June 30, 2020
Net Loss: Net loss was $10.7 million for the quarter ended June 30, 2021, as compared with $9.7 million for the quarter ended June 30, 2020