On August 8, 2022 Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology, obesity and non-alcoholic steatohepatitis (NASH), reported financial results for the second quarter ended June 30, 2022 and corporate highlights (Press release, Terns Pharmaceuticals, AUG 8, 2022, View Source [SID1234617791]).
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"During the second quarter, Terns saw significant progress in advancing three of our internally discovered, small-molecule product candidates towards key clinical readouts in chronic myeloid leukemia, obesity and NASH," said Sen Sundaram, chief executive officer at Terns. "We look forward to assessing the differentiation of these three product candidates, each of which target clinically validated mechanisms of action."
Recent Developments and Anticipated Milestones
TERN-701: Oral, allosteric BCR-ABL tyrosine kinase inhibitor (TKI) for chronic myeloid leukemia
In May 2022, Hansoh Pharmaceutical Group Company Limited (Hansoh) initiated dosing of TERN-701 in a Phase 1 dose-escalation and dose-expansion trial in approximately 100 patients with CML (NCT05367700)
The objectives of this trial are to evaluate the tolerability, efficacy, and pharmacokinetics of TERN-701 in CML
TERN-701 is Terns’ proprietary, allosteric BCR-ABL TKI, designed to target the ABL myristoyl pocket, for the treatment of chronic myeloid leukemia (CML)
TERN-701 aims to address limitations of the only FDA-approved allosteric BCR-ABL TKI with the goal of achieving improved tumor suppression through a combination of: (1) potent activity against CML including a broad range of mutations, (2) improved PK to enable potential once-daily dosing, and (3) minimal food or fasting requirements
TERN-701 is out-licensed to Hansoh for development in the greater China region. Hansoh is responsible for all development costs in China, including the ongoing Phase 1 trial
Terns retains all worldwide development and commercialization rights outside of greater China, as well as access to data generated by Hansoh in China
Terns is exploring options for the development and commercialization of TERN-701 outside of China, including potential internal development and/or additional strategic partnerships
TERN-601: Oral, small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist for obesity
IND-enabling activities for TERN-601, Terns’ lead GLP-1R development candidate, are proceeding on-track with the goal of initiating a first-in-human clinical trial in 2023
The Phase 1 clinical program for TERN-601 is expected to include a single ascending dose trial and a multiple ascending dose proof-of-concept trial assessing potential endpoints such as body weight and HbA1c
TERN-601 is a Terns’ proprietary orally-administered small-molecule glucagon-like peptide-1 receptor (GLP-1R) agonist for the treatment of obesity
Terns screened more than 20,000 molecular permutations through its proprietary quantitative structure activity relationship (QSAR) model to identify suitable small-molecule scaffolds with potentially improved properties relative to other GLP-1-based approaches
Terns has identified structures believed to be suitable for oral administration as a single-agent or in combination with other drug candidates within its pipeline
TERN-501: Oral, thyroid hormone receptor-beta (THR-β) agonist for NASH
In July 2022, Terns initiated dosing in the DUET Phase 2a clinical trial of TERN-501 (THR-β agonist) alone and in combination with TERN-101 (FXR agonist) in approximately 140 adult patients with presumed NASH (NCT05415722)
Primary endpoint is the relative change from baseline in liver fat content as measured by MRI-PDFF at Week 12 for TERN-501 monotherapy compared with placebo
Secondary endpoints include assessment of changes in MRI-PDFF (combination vs. placebo) and MRI cT1 (TERN-501 monotherapy vs. placebo as well as 501+101 combination vs. placebo)
Top-line data expected in the second half of 2023
Key Appointments
Radhika Tripuraneni, M.D., M.P.H. joined the Company’s Board of Directors in July 2022. Dr. Tripuraneni serves as the Chief Development Officer of Prothena Corporation plc and brings to the Terns Board of Directors more than 15 years of experience in drug development
Kerry Russell, M.D., Ph.D. joined the Company as Chief Medical Officer in June 2022. Dr. Russell was most recently vice president of late clinical development at Dicerna Pharmaceuticals, Inc. and was previously an associate professor at Yale University School of Medicine for over 13 years
Upcoming Investor Events
Terns will present at the Canaccord Genuity 42nd Annual Growth Conference on Thursday, August 11, 2022 at 11:30am ET. A live webcast of the event will be available on the investor relations page of the Terns Pharmaceuticals website at View Source A replay of the webcast will be archived on Terns’ website for 30 days following the presentation.
Second Quarter 2022 Financial Results
Cash Position: As of June 30, 2022, cash, cash equivalents and marketable securities were $139.8 million as compared with $166.0 million as of December 31, 2021. Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2025, including through the expected proof-of-concept clinical readouts for TERN-701, TERN-601 and TERN-501
Research and Development (R&D) Expenses: R&D expenses were $8.7 million for the quarter ended June 30, 2022, as compared with $6.0 million for the quarter ended June 30, 2021
General and Administrative (G&A) Expenses: G&A expenses were $5.4 million for the quarter ended June 30, 2022, as compared with $4.9 million for the quarter ended June 30, 2021
Net Loss: Net loss was $13.9 million for the quarter ended June 30, 2022, as compared with $10.7 million for the quarter ended June 30, 2021