Terns Reports First Quarter 2021 Financial Results and Provides Corporate Update

On May 13, 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 first quarter ended March 31, 2021 and provided a corporate update (Press release, Terns Pharmaceuticals, MAY 13, 2021, View Source [SID1234579932]).

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"Our development team has continued to rapidly advance our NASH clinical programs, with top-line data for the Phase 2a LIFT study of FXR agonist TERN-101 in NASH now accelerated into June 2021. In the LIFT study, in addition to safety and tolerability, we are assessing multiple non-invasive endpoints, including MRI-PDFF (proton density fat fraction), a marker of steatosis, as well as ELF (enhanced liver fibrosis) and cT1 (MRI corrected T1) which are markers of fibrosis and/or inflammation linked to clinical outcomes and histological improvements in chronic liver diseases," said Senthil Sundaram, CEO at Terns. "In March, we initiated our first clinical trial of TERN-501 and look forward to announcing top-line data in the second half of 2021 that we hope will provide clinical confirmation of its high metabolic stability and differentiated pharmacokinetic profile."

Recent Developments and Anticipated 2021 Milestones
TERN-101: Liver-distributed farnesoid X receptor (FXR) agonist

Completed patient enrollment in the Phase 2a LIFT study in NASH patients in January 2021
Expecting top-line data from the Phase 2a LIFT study in June 2021
TERN-501: Thyroid hormone receptor-beta (THR-β) agonist

Initiated dosing in a first-in-human Phase 1 SAD/MAD clinical trial in March 2021
Expecting top-line data from the ongoing Phase 1 trial in 2H21
Composition of matter claims allowed by USPTO
TERN-201: Vascular adhesion protein-1 (VAP-1) inhibitor

Expecting to initiate dosing in 12-week Phase 1b clinical trial in NASH patients in 1H21 with expected top-line data in 1H22
GLP1-R: Oral, small-molecule receptor agonist

Expecting to nominate a final candidate in 2H21 for further development
Strengthened balance sheet

Completed an oversubscribed and upsized $147 million initial public offering in February 2021
Cash and equivalents support operations into 2024
Terns also announced today that Erin Quirk, M.D., will assume the position of Head of Research & Development, in addition to President and Chief Medical Officer, effective immediately. Weidong Zhong, Ph.D. will be leaving his position as Chief Scientific Officer and board member, effective as of July 2, 2021. In the interim, Dr. Zhong will continue to support Dr. Quirk to ensure a smooth transition.

Mr. Sundaram continued, "On behalf of our board and our entire team, I would like to thank Weidong for all of the contributions he made in founding Terns but also in successfully building and advancing our diverse NASH pipeline. At the same time, we are pleased to expand Erin’s title in recognition of her ongoing role in leading our research, development and manufacturing teams, which she has done since 2020. With Erin’s leadership, I am confident that we are well positioned to continue to advance our current and future pipeline candidates through all stages of research and development."

First Quarter Financial Results

Cash Position: As of March 31, 2021, cash, cash equivalents and marketable securities were $195.6 million as compared with $74.9 million as of December 31, 2020. Based on its current operating plan, Terns expects these will be sufficient to fund its planned operating expenses into 2024.
Research and Development (R&D) Expenses: R&D expenses were $8.7 million for the quarter ended March 31, 2021, as compared with $7.2 million for the quarter ended March 31, 2020.
General and Administrative (G&A) Expenses: G&A expenses were $4.6 million for the quarter ended March 31, 2021, as compared with $2.2 million for the quarter ended March 31, 2020.
Net Loss: Net loss was $13.3 million for the quarter ended March 31, 2021, as compared with $9.2 million for the quarter ended March 31, 2020.