Septerna (SEPN) investor relations material

Executive summary

• Advanced SEP-479 into Phase 1 clinical trial for hypoparathyroidism, with first participants dosed in April 2026 and Phase 1 SAD/MAD data expected in Q1 2027; observed pharmacokinetics support once-daily dosing.

• SEP-631, an oral MRGPRX2 NAM, showed positive Phase 1 results and is being evaluated for further development in mast cell-driven diseases, with a shift to capital-efficient, signal-finding studies.

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

• Revenue for the quarter and six months ended June 30, 2026, was $26.7M and $53.3M, respectively, driven by the Novo collaboration.

• Net loss for the six months ended June 30, 2026, was $21.7M, a significant improvement from $46.3M in the prior year period.

Financial highlights

• Revenue increased to $26.7M for Q2 2026 from $119K in Q2 2025, and to $53.3M for the six months from $338K in the prior year, due to Novo collaboration milestone and service revenue.

• Operating expenses rose to $43.6M for Q2 2026 (from $29.1M) and $83.4M for the six months (from $55.2M), reflecting higher R&D and G&A costs.

• R&D expenses were $35.1M for Q2 2026 (up from $22.2M); G&A expenses were $8.5M (up from $6.9M).

• Net loss for Q2 2026 was $13.0M, compared to $24.8M in Q2 2025; net loss per share improved to $(0.29) from $(0.56).

• Cash, cash equivalents, and marketable securities totaled $516.5M as of June 30, 2026, expected to fund operations into 2029.

Outlook and guidance

• Anticipates continued net operating losses as R&D and pipeline expansion efforts accelerate.

• Expects to report SEP-479 Phase 1 SAD/MAD data in Q1 2027; SEP-631 development strategy under review.

• Cash runway projected at least into 2029, with ongoing reliance on equity offerings, collaborations, and strategic alliances for funding.