Core Insights - Septerna, Inc. has reported positive Phase 1 results for SEP-631, a drug targeting MRGPRX2, which supports its advancement to Phase 2b development in chronic spontaneous urticaria (CSU) in the second half of 2026 [2][8] - The company is also progressing SEP-479, a PTH1R agonist, towards Phase 1 initiation in the first half of 2026 [4] - Septerna's cash runway is expected to support its operations at least into 2029, with cash, cash equivalents, and marketable securities totaling $548.7 million as of December 31, 2025 [12][16] Pipeline Progress and Milestones - SEP-631 has shown a well-tolerated safety profile and robust pharmacodynamics, achieving complete inhibition of wheal formation at doses as low as 10 mg once daily [8] - SEP-479 is on track for Phase 1 clinical trials, having completed IND-enabling studies [4] - The TSHR NAM program is progressing towards candidate selection for potential treatments for Graves' disease and thyroid eye disease [5] - Discovery-stage programs are advancing across multiple therapeutic areas utilizing the Native Complex Platform [6] Financial Highlights - Revenue for Q4 2025 was $24.1 million, a significant increase from $0.2 million in Q4 2024, and $46.0 million for the full year 2025 compared to $1.1 million in 2024 [12][15] - R&D expenses for Q4 2025 were $31.9 million, up from $19.3 million in Q4 2024, and $97.6 million for the full year 2025 compared to $65.3 million in 2024 [12][15] - General and administrative expenses for Q4 2025 were $8.3 million, compared to $5.6 million in Q4 2024, and $29.2 million for the full year 2025 compared to $16.6 million in 2024 [12][15] - The net loss for Q4 2025 was $10.7 million, an improvement from a net loss of $20.7 million in Q4 2024, and the full year net loss was $48.9 million compared to $71.8 million in 2024 [12][15]
Septerna Highlights Pipeline Progress and Reports Fourth Quarter and Full Year 2025 Financial Results