Summary of Septerna's Conference Call Company Overview - Company: Septerna - Focus: G protein-coupled receptors (GPCRs) and small molecule discovery using the Native Complex platform - Financial Position: Well-capitalized with an operating cash runway into at least 2029 [2][2][2] Key Programs 1. SEP479 Program - Target: Parathyroid hormone receptor agonist for hyperparathyroidism - Clinical Development: Anticipated entry into the clinic in the first half of next year [3][3][9] - Pharmacodynamics: Demonstrated ability to normalize serum calcium and phosphate levels in preclinical studies with low dosing (0.15 mg/kg) [7][7][8] - Safety Profile: Improved pharmaceutical properties compared to previous candidate SEP786, which was discontinued due to safety issues related to bilirubin levels [6][14][15] - Half-Life: Predicted human half-life of 40-80 hours, supporting once-daily dosing [7][17][17] 2. SEP631 Program - Target: MRGPRX2 negative allosteric modulator for mast cell-driven diseases, including chronic spontaneous urticaria - Clinical Development: Currently in phase one trial, with data expected in early 2026 [9][12][25] - Pharmacodynamics: Demonstrated complete inhibition of extravasation in preclinical models [11][11] - Differentiation: Unique profile as an insurmountable negative allosteric modulator, potentially offering a long duration of action [10][19] 3. Thyroid-Stimulating Hormone Receptor Program - Target: Graves' disease and thyroid eye disease - Market Opportunity: Significant unmet need with a large market size; current treatments are outdated [26][26][27] - Mechanism: Utilizing an insurmountable negative allosteric modulator approach to inhibit receptor activation by various antibodies [27][28] Collaborations and Financials - Collaboration with Novo Nordisk: Announced a significant collaboration in May, including $195 million upfront and full support for R&D costs [4][4] Market Context and Competitive Landscape - Mast Cell Indications: Potential to target multiple mast cell-driven diseases, with chronic spontaneous urticaria as the initial focus [21][21] - Competitive Landscape: Acknowledgment of a crowded market for chronic spontaneous urticaria treatments, with a focus on differentiating SEP631 from existing therapies [22][22][19] Future Outlook - Pipeline Expansion: The platform has broader applications for GPCRs, with potential for a deep pipeline of products targeting various therapeutic areas [29][30] - Clinical Trials: Plans to initiate trials for SEP631 in chronic spontaneous urticaria following successful phase one results [25][25] Conclusion - Overall Sentiment: Positive outlook on the progress of Septerna's programs, with a focus on advancing clinical development and addressing significant market needs in the biopharma space [30][30]
Septerna (NasdaqGM:SEPN) FY Conference Transcript