Septerna (SEPN) Q1 2026 earnings summary

Executive summary

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

• Initiated first-in-human Phase 1 trial for SEP-479, an oral PTH1R agonist for hypoparathyroidism, with data expected late 2026 or early 2027.

• Advanced TSHR NAM program toward candidate selection for Graves' disease and thyroid eye disease.

• Revenue for Q1 2026 was $26.5M, driven by the Novo Nordisk collaboration; net loss narrowed to $8.6M from $21.5M year-over-year.

• Chief Medical Officer transition announced, with advisory support during the search for a successor.

Financial highlights

• Q1 2026 revenue: $26.5M (vs. $0.2M Q1 2025), all from Novo collaboration.

• Operating expenses rose to $39.8M (from $26.1M), mainly due to increased R&D and G&A costs.

• R&D expenses increased to $29.5M from $19.3M year-over-year; G&A expenses rose to $10.3M from $6.9M.

• Net loss: $8.6M (improved from $21.5M); EPS: $(0.19) vs. $(0.49) year-over-year.

• Cash, cash equivalents, and marketable securities totaled $522.1M as of March 31, 2026, expected to fund operations into 2029.

Outlook and guidance

• Cash runway projected at least into 2029, supporting ongoing R&D and clinical programs.

• SEP-479 Phase 1 data anticipated late 2026 or early 2027; SEP-631 Phase 2b trial in CSU planned for H2 2026.

• Expects continued net losses as pipeline advances and clinical trials expand.

• No product revenue expected until successful commercialization of candidates.

• Continued advancement of discovery-stage programs and collaborations.