On March 14, 2024 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 and obesity, reported financial results for the fourth quarter and full year ended December 31, 2023 and provided corporate updates (Press release, Terns Pharmaceuticals, MAR 14, 2024, View Source [SID1234641172]).

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"I joined Terns last month at a pivotal stage in the company’s growth as we advance towards initial data readouts from our Phase 1 clinical programs for TERN-601, our oral small molecule GLP-1 agonist for obesity, and TERN-701, our allosteric BCR-ABL inhibitor for CML. Importantly, our global Phase 1 trial of TERN-701 allows for the enrollment of second line CML patients, which makes the study attractive for participants given that there is no allosteric inhibitor currently approved for 2L CML patients," said Amy Burroughs, chief executive officer of Terns. "Terns made meaningful progress throughout 2023, as highlighted by the initiation of these two clinical programs, the positive Phase 2 data readout from our potentially best in class THR-β and the advances in discovery for our small-molecule GIPR modulators for obesity."

Recent Pipeline Developments and Anticipated Milestones

TERN-701: Oral, allosteric BCR-ABL tyrosine kinase inhibitor (TKI) for chronic myeloid leukemia (CML)

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Global Phase 1 CARDINAL trial initiated in fourth quarter 2023 and is progressing
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CARDINAL is a global, multicenter, open-label, two-part Phase 1 clinical trial to evaluate the safety, pharmacokinetics (PK) and efficacy of TERN-701 in patients with previously treated CML
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The study design leverages insights from the ongoing Phase 1 trial in China, which support a starting dose that appears safe and clinically active based on emerging early clinical data
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The CARDINAL trial design provides multiple opportunities to potentially differentiate TERN-701 in the CML treatment landscape
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Opportunity to efficiently develop TERN-701 as a dose-optimized allosteric inhibitor for CML
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Inclusion of second-line (2L) chronic phase CML patients, which better positions Terns to potentially move directly into a 2L (or earlier line) pivotal study
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Reduced competition for trial enrollment as no allosteric inhibitor is currently approved for 2L CML patients
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Interim data from initial CARDINAL dose escalation cohorts expected in the second half of 2024
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In March 2024, the United States Food and Drug Administration (FDA) granted Orphan Drug Designation for TERN-701 for the treatment of chronic myeloid leukemia
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Terns plans to host a virtual KOL event in mid-2024 to focus on the interpretation of early CML datasets

TERN-601: Oral, small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist for obesity

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Phase 1 clinical trial of Terns’ lead oral GLP-1 receptor agonist in healthy obese or overweight participants is ongoing
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Primary endpoints include safety and tolerability assessments
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Secondary and exploratory endpoints include PK and change in body weight over 28 days
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Top-line data, including 28-day body weight loss, expected in the second half of 2024
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Terns continues preclinical efforts to identify promising oral, small-molecule combination candidates for obesity (e.g., GLP-1 + THR-β, GLP-1 + GIPR agonist / antagonist)

TERN-501: Oral, thyroid hormone receptor-beta (THR-β) agonist

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Terns continues to evaluate opportunities for TERN-501 in metabolic diseases
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Based on non-clinical studies, THR-β is an orthogonal mechanism to GLP-1, potentially providing broader metabolic and liver benefits in addition to increased weight loss
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Non-clinical data suggests that TERN-501 may augment the weight loss effects of a GLP-1 receptor agonist, as demonstrated in a diet-induced obese mouse model
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Terns has decided to limit spend in MASH given the current regulatory and clinical development requirements for the indication

TERN-800 Series: Oral, small-molecule glucose-dependent insulinotropic polypeptide receptor (GIPR) modulators

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Discovery efforts are ongoing for the TERN-800 series of small molecule GIPR modulators for obesity
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GIPR modulators (agonists and antagonists) have the potential for combination with GLP-1 receptor agonists, such as TERN-601

Corporate Updates

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In February 2024, Terns announced the appointment of Amy Burroughs as chief executive officer and board member of Terns

Fourth Quarter and Full Year 2023 Financial Results

Cash Position: As of December 31, 2023, cash, cash equivalents and marketable securities were $263.4 million, as compared with $283.1 million as of December 31, 2022. Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2026.

Research and Development (R&D) Expenses: R&D expenses were $17.5 million and $63.5 million for the quarter and year ended December 31, 2023, respectively, as compared with $10.7 million and $39.6 million for the quarter and year ended December 31, 2022, respectively.

General and Administrative (G&A) Expenses: G&A expenses were $6.6 million and $39.1 million for the quarter and year ended December 31, 2023, respectively, as compared with $6.2 million and $22.4 million for the quarter and year ended December 31, 2022, respectively.

Net Loss: Net loss was $21.0 million and $90.2 million for the quarter and year ended December 31, 2023, respectively, as compared with $15.8 million and $60.3 million for the quarter and year ended December 31, 2022, respectively.