Septerna (SEPN) Q4 2025 earnings summary

Executive summary

• Achieved positive Phase 1 results for SEP-631, supporting advancement to Phase 2b in chronic spontaneous urticaria in H2 2026.

• SEP-479 completed IND-enabling studies, with Phase 1 initiation planned for H1 2026.

• Expanded pipeline with ongoing discovery-stage programs and progress in TSHR NAM for Graves' disease.

• Appointed new chief legal officer in January 2026.

Financial highlights

• Cash, cash equivalents, and marketable securities totaled $548.7M as of Dec 31, 2025, up from $420.8M a year prior.

• Revenue was $24.1M for Q4 2025 and $46.0M for FY 2025, compared to $0.2M and $1.1M in the prior year.

• R&D expenses were $31.9M for Q4 2025 and $97.6M for FY 2025, up from $19.3M and $65.3M year-over-year.

• Net loss was $10.7M for Q4 2025 and $48.9M for FY 2025, improved from $20.7M and $71.8M in the prior year.

• Received $195M upfront from Novo Nordisk and $12.5M milestone from Vertex in 2025.

Outlook and guidance

• Cash runway expected to fund operations at least into 2029.

• Phase 2b trial for SEP-631 in CSU planned for H2 2026, pending long-term toxicology results.

• SEP-479 Phase 1 trial initiation targeted for H1 2026.