Terns Pharmaceuticals(TERN) - 2025 Q1 - Quarterly Results

Terns Pharmaceuticals First Quarter 2025 Report Corporate and Clinical Highlights The company advanced its lead CML and obesity programs, anticipating key data in H2 2025 while maintaining a cash runway into 2028 - Initiated the dose expansion portion of the Phase 1 CARDINAL trial for TERN-701 in Chronic Myeloid Leukemia (CML)[1][2] - The Phase 2 FALCON trial for TERN-601 in obesity is enrolling well, with top-line 12-week weight loss data expected in Q4 2025[1][2] - TERN-701 demonstrated a highly encouraging safety profile with no dose-limiting toxicities up to the maximum 500 mg dose in the dose escalation phase[2] - The company confirms its cash runway is sufficient to fund operations into 2028[2] Clinical Pipeline Developments The company detailed progress for its CML and obesity programs and outlined discovery efforts for its TERN-800 series and TERN-501 TERN-701 for CML The Phase 1 CARDINAL study advanced to dose expansion, with key 6-month MMR efficacy data expected in Q4 2025 - The first patient was enrolled in the dose expansion portion of the Phase 1 CARDINAL study in April 2025[3] - Patients in the expansion phase will be randomized to either a 320 mg or 500 mg once-daily (QD) dose, with up to 40 patients per arm[3] - Additional safety and efficacy data, including 6-month MMR rates, are planned for release in Q4 2025 to inform the path to a pivotal trial[3] - Interim data from December 2024 showed an encouraging safety profile with no dose-limiting toxicities or treatment discontinuations due to adverse events[3] TERN-601 for Obesity The Phase 2 FALCON trial is enrolling patients, with top-line 12-week weight loss data expected in Q4 2025 - The primary endpoint of the Phase 2 FALCON trial is the percent change from baseline in body weight compared to placebo over 12 weeks[6] - The trial is evaluating four active cohorts (250 mg, 500 mg, 500 mg slow titration, 750 mg) against a placebo, with 30 patients per cohort[6] - Top-line 12-week data from the FALCON trial is anticipated in Q4 2025[6] Other Pipeline Programs The company is advancing its TERN-800 GIPR antagonist program and positions TERN-501 as a complementary therapy to GLP-1 - TERN-800 Series: The company is prioritizing the nomination of a glucose-dependent insulinotropic polypeptide receptor (GIPR) antagonist for obesity treatment, potentially in combination with a GLP-1 agonist[6] - TERN-501: This oral thyroid hormone receptor-beta (THR-β) agonist is considered a complementary mechanism to GLP-1, potentially offering additional metabolic, liver, and weight loss benefits[6] Corporate Updates Senior leadership will participate in two key investor conferences in June 2025 - Management will participate in the Jefferies Global Healthcare Conference (June 3-5, 2025) and the Goldman Sachs 46th Annual Global Healthcare Conference (June 9-11, 2025)[6] First Quarter 2025 Financial Results The company reported a Q1 net loss of $23.9 million and ended the quarter with $334.3 million in cash, sufficient into 2028 - Cash, cash equivalents, and marketable securities were $334.3 million as of March 31, 2025, sufficient to fund planned operating expenses into 2028[7] Key Financial Metrics The company's Q1 2025 net loss increased to $23.9 million, driven by higher G&A expenses while R&D costs remained stable Q1 2025 vs Q1 2024 Financial Comparison | Metric | Q1 2025 ($M) | Q1 2024 ($M) | | :--- | :--- | :--- | | R&D Expenses | $18.7 | $18.6 | | G&A Expenses | $8.7 | $6.9 | | Net Loss | $23.9 | $22.4 | Cash Position Comparison | Metric | March 31, 2025 ($M) | December 31, 2024 ($M) | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $334.3 | $358.2 | Condensed Consolidated Statements of Operations Total operating expenses of $27.4 million resulted in a net loss of $23.9 million, or ($0.26) per share, for Q1 2025 Terns Pharmaceuticals, Inc. Condensed Consolidated Statements of Operations (Unaudited; in thousands except share and per share amounts) | | Three Months Ended March 31, | | | :--- | :--- | :--- | | | 2025 | 2024 | | Operating expenses: | | | | Research and development | $18,720 | $18,587 | | General and administrative | $8,707 | $6,859 | | Total operating expenses | $27,427 | $25,446 | | Loss from operations | ($27,427) | ($25,446) | | Interest income | $3,643 | $3,182 | | Other expense, net | ($36) | ($12) | | Loss before income taxes | ($23,820) | ($22,276) | | Income tax expense | ($88) | ($97) | | Net loss | ($23,908) | ($22,373) | | Net loss per share, basic and diluted | ($0.26) | ($0.30) | | Weighted average common stock outstanding | 91,473,948 | 74,399,378 | Selected Balance Sheet Data Total assets were $339.3 million and stockholders' equity was $326.0 million as of March 31, 2025 Terns Pharmaceuticals, Inc. Selected Balance Sheet Data (Unaudited; in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $334,264 | $358,164 | | Total assets | $339,315 | $363,929 | | Total liabilities | $13,272 | $18,059 | | Total stockholders' equity | $326,043 | $345,870 | Company Information and Disclosures About Terns Pharmaceuticals The company is a clinical-stage biopharmaceutical firm developing small-molecule candidates for oncology and obesity - The company's pipeline includes an allosteric BCR-ABL inhibitor (TERN-701), a small-molecule GLP-1 receptor agonist (TERN-601), a THR-β agonist (TERN-501), and a preclinical GIPR modulator discovery program[11] Cautionary Note Regarding Forward-Looking Statements The report includes forward-looking statements regarding clinical trials, product potential, and financial runway that involve significant risks - Forward-looking statements relate to expectations for clinical trials (CARDINAL, FALCON), potential of product candidates (TERN-701, TERN-601, TERN-800 Series, TERN-501), and the company's cash runway[12] - Investors are cautioned not to place undue reliance on these statements as they are based on current expectations and are subject to risks detailed in the company's SEC filings[12]