Septerna Earnings Call Transcripts
Fiscal Year 2026
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The meeting saw the election of two directors and ratification of the auditor, with all proposals approved. Key pipeline programs advanced, including SEP-479 and SEP-631, and strong financials were reported with $522 million in cash. Strategic partnerships and future clinical milestones were highlighted.
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Two lead GPCR-targeting programs are advancing in clinical trials, with SEP-479 in phase I for hypoparathyroidism and SEP-631 moving to phase II for urticaria. The proprietary platform enables rapid discovery of novel drug candidates, and the pipeline includes additional programs for Graves' disease and incretin agonists.
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SEP-631 showed robust phase I results and will enter a 12-week, dose-ranging phase II trial for chronic spontaneous urticaria in the second half of the year. SEP-479, an oral PTH agonist, is set to begin phase I trials soon, with titration and monitoring strategies to be refined in later phases.
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SEP-631 demonstrated a favorable safety profile and robust, dose-dependent inhibition of MRGPRX2 signaling in a phase I trial, supporting once-daily oral dosing without food restrictions. These results validate clinical proof of mechanism and support advancement into phase II studies for chronic spontaneous urticaria and other mast cell-driven diseases.
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The presentation highlighted rapid GPCR drug discovery enabled by the Native Complex Platform, with SEP-479 and SEP-631 advancing in clinical development for hypoparathyroidism and mast cell diseases, respectively. Strong market opportunities, robust IP, and strategic collaborations support a well-capitalized, diversified pipeline.
Fiscal Year 2025
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The company presented progress on its GPCR-focused pipeline, highlighting SEP-479 for hyperparathyroidism and SEP-631 for mast cell diseases, both advancing toward key clinical milestones in 2024. A TSHR NAM program is also progressing, with Graves' disease as the initial target.
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The summit highlighted progress on two lead programs: SEP-631, a once-daily oral MRGPRX2 inhibitor in phase I for mast cell diseases, and SEP-479, a PTH1 receptor agonist for hypoparathyroidism expected to enter the clinic next year. Additional pipeline and partnership updates were shared.
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A novel GPCR drug discovery platform is advancing multiple programs, including SEP-479 for hyperparathyroidism and SEP-631 for mast cell diseases, both with strong preclinical and early clinical progress. A major Novo Nordisk collaboration and robust cash position support continued pipeline growth.
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SEP-479, a next-generation PTH receptor agonist, showed strong preclinical efficacy and safety, with phase one trials planned for next year. SEP-631, targeting MRGPRX2, is in phase one with a broad indication strategy. A major Novo Nordisk partnership supports expansion into metabolic diseases.
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The presentation highlighted a robust GPCR-focused drug discovery platform, major updates on SEP-479 for hypoparathyroidism with improved efficacy and safety, and progress on SEP-631 for mast cell diseases. Strong financials and strategic partnerships support a broad, advancing pipeline.
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The presentation highlighted a robust GPCR-focused drug discovery platform, with multiple programs advancing in endocrinology, immunology, and metabolic disease. Next-generation candidates are progressing toward clinical trials, and a major Novo Nordisk collaboration strengthens financial runway and R&D capacity.
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A proprietary platform enables rapid GPCR drug discovery, advancing four programs targeting major unmet needs. Lead asset SEP786, an oral PTH receptor agonist, is in phase 1 with mid-year data expected, while SEP631 and other programs progress toward the clinic.