On March 30, 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 fourth quarter and full year ended December 31, 2020 and provided a corporate update (Press release, Terns Pharmaceuticals, MAR 30, 2021, View Source [SID1234577361]).

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2020 Business Highlights and Recent Developments

TERN-101 – Liver-distributed farnesoid X receptor (FXR) agonist

Completed patient enrollment in the Phase 2a LIFT study in January 2021; reported final results from a Phase 1 clinical trial, which confirmed sustained liver FXR activation and a favorable tolerability profile
TERN-201 – Vascular adhesion protein-1 (VAP-1) inhibitor

Reported positive results from the completed Phase 1 SAD/MAD clinical trial that demonstrated robust and sustained target engagement and tolerability
TERN-501 – Thyroid hormone receptor-beta (THR-β) agonist

Initiated dosing in a first-in-human Phase 1 SAD/MAD clinical trial
Expanded board of directors

Appointed three industry leaders to the board of directors: David Fellows, most recently Chief Executive Officer (CEO) of Nightstar Therapeutics, Jeff Kindler, CEO of Centrexion Therapeutics and former CEO of Pfizer, and Jill M. Quigley Chief Operating Officer at Passage Bio
Key management team appointments

Added Senthil Sundaram, formerly Chief Financial Officer (CFO) of Nightstar Therapeutics, as CEO and Board Director, Mark Vignola, Ph.D., formerly CFO of Applied Therapeutics, as CFO, and Bryan Yoon, formerly Chief Administrative Officer, General Counsel and Secretary of LogicBio Therapeutics, as Chief Operating Officer and General Counsel, and promoted Erin Quirk, M.D., to President
Strengthened balance sheet

Closed an $87 million Series C financing led by Deerfield Management Company alongside a strategic equity investment from Eli Lilly and Company in December 2020 and completed an upsized $147 million initial public offering in February 2021
Anticipated 2021 Milestones

TERN-101

Report top-line data from the ongoing Phase 2a LIFT study in NASH patients in July 2021
TERN-201

Initiate 12-week Phase 1b clinical trial in NASH patients in 1H21 with expected top-line data in 1H22
TERN-501

Report top-line data from the ongoing Phase 1 trial in 2H21
GLP1-R agonist (oral):

Nominate a final candidate for further development in NASH in 2H21
"2020 was a year of significant growth and momentum at Terns, during which the team made tremendous progress advancing our pipeline of single-agent and combination NASH therapies which in turn allowed us to significantly strengthen our financial position," said Senthil Sundaram, CEO at Terns. "With the recent initiation of our Phase 1 clinical trial of TERN-501, we now have three clinical-stage NASH programs focused on clinically validated targets. As we look ahead to 2021 and 2022, we anticipate data readouts for all three of our ongoing clinical programs and look forward to initiating our first combination clinical trial of TERN-101 and TERN-501 – all with the goal of developing best-in-class therapies we hope can change the lives of people with NASH."

Full Year and Fourth Quarter Financial Results

Cash, Cash Equivalents and Investments Position: As of December 31, 2020, cash, cash equivalents and investments were $74.9 million as compared with $19.7 million as of December 31, 2019. Based on its current operating plan, Terns expects its cash and cash equivalents will be sufficient to fund its planned operating expenses into 2024.
Research and Development (R&D) Expenses: R&D expenses were $7.8 million and $28.0 million for the quarter and year ended December 31, 2020, respectively, as compared with $7.6 million and $61.5 million for the quarter and year ended December 31, 2019, respectively.
General and Administrative (G&A) Expenses: G&A expenses were $1.0 million and $9.0 million for the quarter and year ended December 31, 2020, respectively, as compared with $2.4 million and $8.7 million for the quarter and year ended December 31, 2019, respectively.
Net Loss: Net loss was $9.9 million and $40.6 million for the quarter and year ended December 31, 2020, respectively, as compared with $10.0 million and $68.8 million for the quarter and year ended December 31, 2019, respectively.