Terns Pharmaceuticals(US:TERN)2022-05-16 20:43Drug Development - The company is developing a portfolio of small-molecule therapies targeting serious diseases such as non-alcoholic steatohepatitis (NASH), obesity, and cancer, with a focus on THR-β and FXR mechanisms [117]. - TERN-501, a THR-β agonist, showed positive Phase 1 trial results, demonstrating safety and tolerability with no serious adverse events reported [118]. - The FDA cleared the IND application for TERN-501 and TERN-101, leading to a Phase 2a trial expected to enroll approximately 140 NASH patients, with top-line data anticipated in the second half of 2023 [119]. - The company aims to develop TERN-601, an oral GLP-1R agonist for obesity, with a first-in-human clinical trial planned for 2023 after identifying suitable small-molecule scaffolds [120]. - TERN-101 demonstrated significant improvements in liver inflammation and fibrosis markers in a Phase 2a study, indicating its potential in combination therapies for NASH [121]. - TERN-201, an inhibitor of VAP-1, met primary safety endpoints in a Phase 1b trial, but did not show meaningful changes in NASH biomarkers, leading to limited further investment in this candidate [123]. - TERN-701, a BCR-ABL TKI for chronic myeloid leukemia, is in development in China, with a Phase 1 trial initiated by Hansoh Pharmaceuticals [124]. - The company has prioritized resources towards TERN-501 and TERN-601, expecting cash reserves to fund operations into 2025, including key data readouts [125]. Financial Performance - The company has not generated any revenue from product sales and will not do so until successful clinical development and regulatory approval of its therapy candidates [126]. - For the three months ended March 31, 2022, total operating expenses were $13,825,000, an increase of 4% from $13,296,000 in the same period of 2021 [130]. - Research and development expenses decreased by $599,000 to $8,136,000, primarily due to a $2.0 million decrease in clinical program expenses [130][133]. - General and administrative expenses increased by $1,128,000 to $5,689,000, driven by a $0.8 million increase in personnel-related expenses [130][136]. - The net loss for the three months ended March 31, 2022, was $13,773,000, compared to a net loss of $13,337,000 for the same period in 2021, reflecting a 3.3% increase in losses [130]. - As of March 31, 2022, the company had an accumulated deficit of $195.8 million and cash, cash equivalents, and marketable securities totaling $151.3 million [144]. - The company expects to incur net operating losses for at least the next several years and anticipates significant research and development expenses [142][149]. - Net cash used in operating activities during the three months ended March 31, 2022, was $13.3 million, compared to $14.3 million in the same period of 2021 [153][154]. - Net cash provided by investing activities for the three months ended March 31, 2022, was $9.5 million, primarily from the sale and maturity of investments [155]. - The company entered into a Sales Agreement in March 2022 to offer shares of common stock with an aggregate offering price of up to $75.0 million [147]. - The company will need substantial additional funding to support ongoing operations and research activities, which may come from equity or debt financings [149][151]. Operational Challenges - The ongoing COVID-19 pandemic continues to pose uncertainties regarding the company's operations and development timelines [129].