Terns Pharmaceuticals(TERN) - 2024 Q4 - Annual Results

Report Overview and Key Highlights - Announced significant clinical progress in 2024 for its lead programs, TERN-701 in CML and TERN-601 in obesity, with key data readouts expected in 2025[2] - The dose expansion for the Phase 1 CARDINAL trial of TERN-701 (CML) is expected to start in Q2 2025, with additional data anticipated in Q4 2025[1] - The first patient was enrolled in the Phase 2 FALCON trial of TERN-601 (obesity), with 12-week data expected in Q4 2025[1] - The company reports a strong financial position with $358 million in cash, cash equivalents, and marketable securities, providing an expected operational runway into 2028[1] Pipeline Developments and Anticipated Milestones TERN-701 for Chronic Myeloid Leukemia (CML) TERN-701, an oral TKI for CML, completed Phase 1 dose escalation with compelling molecular responses and favorable safety, with dose expansion starting Q2 2025 and data expected Q4 2025 - Phase 1 dose escalation was completed in January 2025, with interim data showing compelling molecular responses and an encouraging safety profile in heavily pre-treated CML patients[3] - Positive drug-drug interaction (DDI) data indicates TERN-701 is not a clinically relevant inhibitor of CYP3A4 or OATP1B1/3, representing a key safety differentiation within its class[3] - The dose expansion part of the Phase 1 study is expected to start in Q2 2025, with additional safety and efficacy data anticipated in Q4 2025[3] TERN-601 for Obesity TERN-601, an oral GLP-1 agonist for obesity, enrolled its first Phase 2 FALCON patient; 12-week data expected Q4 2025, evaluating efficacy and safety with a slower titration schedule - The Phase 2 FALCON clinical trial enrolled its first patient in March 2025, with 12-week data expected in Q4 2025[6] - The trial's primary endpoint is the percent change from baseline in body weight compared to placebo over 12 weeks[6] - The Phase 2 trial will use a slower titration schedule (two to four weeks at each intermediate dose) to aim for competitive weight loss with best-in-class tolerability[6] Other Pipeline Programs (TERN-501 & TERN-800 Series) Terns evaluates TERN-501 for metabolic diseases, potentially with GLP-1s, and advances TERN-800 series GIPR modulators, prioritizing a GIPR antagonist for obesity combination therapies - TERN-501 (THR-β agonist): The company continues to evaluate opportunities for TERN-501 in metabolic diseases, noting its complementary mechanism to GLP-1 for potential broader benefits[6] - TERN-800 Series (GIPR modulators): Discovery efforts are ongoing, with a focus on nominating a GIPR antagonist candidate to combine with GLP-1 agonists like TERN-601 for obesity treatment[6] Corporate Updates Terns strengthened its leadership by appointing Andrew Gengos as CFO and adding Robert Azelby and Heather Turner to its board of directors - In February 2025, Andrew Gengos was appointed as Chief Financial Officer[11] - In February 2025, Robert Azelby was appointed to the board of directors[11] - In November 2024, Heather Turner was appointed to the board of directors[11] Fourth Quarter and Full Year 2024 Financial Results Financial Summary Terns ended 2024 with $358.2 million cash, providing runway into 2028; R&D increased, G&A decreased, and net loss narrowed to $88.9 million - Cash, cash equivalents, and marketable securities were $358.2 million as of Dec 31, 2024, compared to $263.4 million a year prior. The company expects these funds to be sufficient to support operations into 2028[8] Comparison of Key Financial Metrics (Full Year) | Metric | FY 2024 (Millions USD) | FY 2023 (Millions USD) | Change | | :--- | :--- | :--- | :--- | | R&D Expenses | $70.1 | $63.5 | +10.4% | | G&A Expenses | $31.8 | $39.1 | -18.7% | | Net Loss | $88.9 | $90.2 | -1.4% | Condensed Consolidated Statements of Operations The company reported a net loss of $21.8 million for Q4 2024 and $88.9 million for FY 2024, with full-year net loss per share improving to $(1.12) from $(1.27) in 2023 Statement of Operations Highlights (in thousands, except per share data) | Metric | Q4 2024 (Thousands USD) | Q4 2023 (Thousands USD) | FY 2024 (Thousands USD) | FY 2023 (Thousands USD) | | :--- | :--- | :--- | :--- | :--- | | R&D Expenses | $18,004 | $17,459 | $70,112 | $63,497 | | G&A Expenses | $7,945 | $6,599 | $31,759 | $39,061 | | Total Operating Expenses | $25,949 | $24,058 | $101,871 | $102,558 | | Net Loss | $(21,799) | $(21,019) | $(88,853) | $(90,210) | | Net Loss Per Share | $(0.24) | $(0.29) | $(1.12) | $(1.27) | Selected Balance Sheet Data As of December 31, 2024, Terns' cash, cash equivalents, and marketable securities significantly increased to $358.2 million from $263.4 million, with total assets growing to $363.9 million and stockholders' equity to $345.9 million Balance Sheet Highlights (in thousands) | Metric | Dec 31, 2024 (Thousands USD) | Dec 31, 2023 (Thousands USD) | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $358,164 | $263,440 | | Total assets | $363,929 | $268,517 | | Total liabilities | $18,059 | $13,150 | | Total stockholders' equity | $345,870 | $255,367 |