Septerna — Third Quarter 2026 Earnings Summary

Financial Performance:

• Revenue for the quarter ended September 30, 2026, was $18.9 million, a decrease from $21.5 million in the same period of 2025.
• Revenue composition included $2.7 million in amortization of the $195.0 million upfront payment from Novo Nordisk, $5.2 million from research milestones, and $11.0 million from research services.
• Research and development (R&D) expenses were $36.6 million for the quarter, compared to $24.3 million in the prior year period.
• General and administrative (G&A) expenses were $9.6 million for the quarter, compared to $7.1 million in the prior year period.
• Net loss for the quarter was $26.6 million, contrasting with a net income of $8.2 million in the prior year period.
• Cash, cash equivalents, and marketable securities totaled $565.2 million as of September 30, 2026, compared to $548.7 million as of December 31, 2025.
• Working capital was $402.5 million as of September 30, 2026, compared to $324.0 million as of December 31, 2025.
• Total assets were $619.4 million as of September 30, 2026, compared to $596.2 million as of December 31, 2025.
• Total liabilities were $191.5 million as of September 30, 2026, compared to $214.3 million as of December 31, 2025.
• Accumulated deficit increased to $(215.5) million as of September 30, 2026, from $(167.3) million as of December 31, 2025.

Guidance and Future Outlook:

• The company expects its existing cash runway to fund operations at least into mid-2029.
• Phase 1 single-ascending dose (SAD) and multiple-ascending dose (MAD) data for SEP-479 are expected in the first quarter of 2027.
• A Phase 1 clinical trial for the newly selected development candidate SEP-204 is anticipated to initiate in the first quarter of 2027.

Business Segments and Product Lines:

• SEP-479 (PTH1R Agonist): The Phase 1 clinical trial for hypoparathyroidism is ongoing in healthy volunteers.
• SEP-204 (TSHR NAM): Selected as the development candidate for Graves' disease and thyroid eye disease; preclinical data showed potent TSHR inhibition, restoration of T4 levels, and reduced thyroid enlargement in animal models. It demonstrated a favorable pharmacokinetic profile in 28-day GLP toxicology studies.
• SEP-631 (MRGPRX2 NAM): Following positive Phase 1 results in March 2026, the company is evaluating capital-efficient, signal-finding clinical studies for mast cell-driven diseases.
• Novo Collaboration: Under the global collaboration initiated in July 2025, Novo assumed responsibility for a development candidate and initiated IND-enabling toxicology studies for obesity, type 2 diabetes, and cardiometabolic diseases. Septerna has achieved $13 million in research milestones to date.
• Discovery Programs: Advancement continues on wholly owned discovery-stage programs using the Native Complex Platform®, including a PTH1R agonist for osteoporosis.

Market and Competitive Landscape:

• The company is pioneering G protein-coupled receptor (GPCR) drug discovery with a focus on differentiated oral medicines for significant unmet needs.
• SEP-204 is positioned as a potential disease-modifying treatment for Graves' disease and thyroid eye disease.
• SEP-631 targets mast cell-driven diseases with high unmet need.

Risks and Challenges:

• Forward-looking statements highlight risks related to product candidates successfully entering and advancing through clinical trials, including uncertainties regarding IND openings and regulatory approvals.
• Risks include unexpected safety or efficacy findings in clinical development and preclinical studies not being predictive of future outcomes.
• Risks involve the timing of initiating clinical studies and the future availability of clinical data.
• Risks include the scope of intellectual property protection for the Native Complex Platform® and product candidates.
• Risks include the ability to identify and enter into future license agreements and collaborations.

Management Commentary and Tone:

• CEO Jeffrey Finer, M.D., Ph.D., stated the company is "building momentum across our portfolio" and moving closer to realizing its ambition to translate GPCR expertise into differentiated oral medicines.
• Management highlighted the upcoming clinical milestone for SEP-479 and the selection of SEP-204 as key drivers for the pipeline.

Other Key Points:

• In August 2026, Septerna appointed Rajiv Patni, M.D., as Chief Medical Officer, bringing over 25 years of experience in research, development, regulatory, and medical affairs.
• The company disclosed material nonpublic information via its Investor Relations website and LinkedIn to comply with Regulation FD.
• The Novo collaboration involves a $195.0 million upfront payment, of which $2.7 million was amortized in Q3 2026.
• The company reported a gain on the sale of a non-financial asset of $12.5 million in the nine-month period ended September 30, 2025, with no such gain in the current period.