Core Insights - Septerna, Inc. is advancing its next-generation oral small molecule PTH1R agonist program for hypoparathyroidism, with plans to select a development candidate in Q3 2025 and initiate a Phase 1 clinical trial in H1 2026 [2][3] - The company is also initiating a Phase 1 clinical trial for SEP-631, an oral small molecule for mast cell diseases, in Q3 2025 [7] - Septerna's cash position is strong, with $379.2 million in cash and equivalents as of June 30, 2025, and an expected cash runway extending into 2029 following a $195 million upfront payment from Novo Nordisk [12][15] PTH1R Agonist Program - The PTH1R agonist program aims to provide full-day calcium control for patients with hypoparathyroidism, with a development candidate selection expected in Q3 2025 [3] - A Phase 1 clinical trial is planned to commence in the first half of 2026 after successful preclinical development [3] SEP-631 MRGPRX2 NAM Program - SEP-631 is a selective oral small molecule MRGPRX2 negative allosteric modulator for mast cell diseases, with a Phase 1 trial to assess safety and tolerability in healthy volunteers starting in Q3 2025 [7] Collaboration with Novo Nordisk - A global collaboration and license agreement with Novo Nordisk became effective on July 1, 2025, focusing on the discovery and development of oral small molecule therapies for obesity, type 2 diabetes, and other cardiometabolic diseases [7] - Septerna received a $195 million upfront payment as part of this collaboration [7] Business Highlights - The company continues to progress its TSHR NAM program, moving multiple lead compounds closer to development candidate selection for treating Graves' disease and thyroid eye disease [7] - Septerna's discovery-stage programs are advancing across various therapeutic areas utilizing its Native Complex Platform™ [7] Financial Results - For Q2 2025, Septerna reported R&D expenses of $22.2 million, up from $15.0 million in Q2 2024, and G&A expenses of $6.9 million, compared to $3.4 million in the same period [12] - The net loss for Q2 2025 was $24.8 million, compared to a net loss of $16.4 million in Q2 2024 [12][14]