Core Insights - Septerna, Inc. has selected SEP-479 as its next-generation oral PTH1R agonist development candidate for hypoparathyroidism and is currently conducting a Phase 1 clinical trial for SEP-631 targeting MRGPRX2 for mast cell-driven diseases [2][3] - The company reported a robust financial position with cash, cash equivalents, and marketable securities totaling $561.6 million, expected to support operations at least into 2029 [1][13] Business Updates - SEP-479 demonstrated robust, dose-dependent increases in serum calcium and decreases in endogenous parathyroid hormone levels in a seven-day study in healthy cynomolgus monkeys, with plans to initiate a Phase 1 clinical trial in the first half of 2026 [7][3] - The ongoing Phase 1 clinical trial for SEP-631 is evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics, with initial data expected in the first half of 2026 [4][2] - Septerna is advancing its TSHR NAM program aimed at developing a potential oral treatment for Graves' disease and thyroid eye disease [8] Financial Performance - Revenue for the quarter ended September 30, 2025, was $21.5 million, a significant increase from $0.2 million in the same quarter of 2024, driven by the amortization of the $195 million upfront payment from Novo Nordisk [13] - Research and development expenses were $24.3 million for the quarter, compared to $17.8 million in the same quarter of 2024, while general and administrative expenses rose to $7.1 million from $4.9 million [13] - The company reported a net income of $8.2 million for the quarter, a turnaround from a net loss of $20.5 million in the same quarter of 2024 [13]
Septerna Highlights Company Progress and Reports Third Quarter 2025 Financial Results