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- Departure of CMO (new) — Chief Medical Officer is leaving for another opportunity as the company advances two clinical programs; successor search underway with advisory transition planned.
Septerna reports Q1 2026 results with $522M cash, Phase 1 SEP-631 data, and CMO departure
Filed May 11, 2026 · Period ending May 11, 2026 · ~1 min read
Key Changes
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high
Q1 2026 net loss narrowed to $8.6M from $21.5M year-ago on $26.5M collaboration revenue (vs. $0.2M prior year); $522M cash extends runway into 2029
Exhibit 99.1 view on EDGAR → -
high
Phase 1 data for SEP-631 (MRGPRX2 inhibitor) showed good tolerability, once-daily dosing profile, and dose-dependent wheal suppression; Phase 2b trial in chronic urticaria planned for H2 2026
Exhibit 99.1 view on EDGAR → -
high
Phase 1 trial initiated for SEP-479 (oral PTH1R agonist) in hypoparathyroidism; data expected late 2026 or early 2027
Exhibit 99.1 view on EDGAR → -
medium
Chief Medical Officer Jae Kim departing to pursue opportunity in Southern California; will serve as advisor during transition while company searches for successor
Exhibit 99.1 view on EDGAR → -
medium
Novo Nordisk collaboration generated $26.5M Q1 revenue including $15.7M amortized upfront payment, $0.5M milestone achievement, and $10.3M research services
Exhibit 99.1 view on EDGAR →
Summary
Septerna reported Q1 2026 results showing improved financial performance and clinical progress across its GPCR-targeted pipeline. The company's net loss narrowed to $8.6 million from $21.5 million in the prior-year quarter, driven primarily by $26.5 million in collaboration revenue from Novo Nordisk (versus $0.2 million from Vertex a year earlier).
With $522 million in cash and marketable securities, Septerna expects to fund operations into 2029. On the clinical front, the company presented positive Phase 1 data for SEP-631, its oral MRGPRX2 inhibitor for chronic spontaneous urticaria, demonstrating good tolerability, once-daily dosing potential, and dose-dependent efficacy in suppressing skin wheal formation.
A Phase 2b trial is planned for the second half of 2026 pending completion of long-term toxicology studies. Separately, Septerna initiated a Phase 1 trial for SEP-479, an oral PTH1R agonist for hypoparathyroidism, with data expected in late 2026 or early 2027. The departure of Chief Medical Officer Jae Kim introduces a leadership transition concern as the company advances two clinical programs simultaneously. Dr. Kim is leaving to pursue an opportunity closer to his Southern California residence and will serve in an advisory capacity while the company searches for a successor. The timing of this executive departure warrants monitoring given the planned Phase 2b initiation and ongoing Phase 1 readout.
Section-by-Section Diff
Event · Exhibit 99.1
Septerna reports Q1 2026 results, Phase 1 data for SEP-631, Phase 1 initiation for SEP-479, and CMO departure; cash runway extends into 2029.
Added in current filing · view on EDGAR →
Cash, cash equivalents, and marketable securities totaled $522.1 million as of March 31, 2026. Septerna expects its existing cash runway to fund operations at least into 2029. ... Revenue from the Novo Nordisk collaboration was $26.5 million for the quarter ended March 31, 2026, compared to $0.2 million from Vertex for the quarter ended March 31, 2025. ... Research and development (R&D) expenses were $29.5 million for the quarter ended March 31, 2026, compared to $19.3 million for the quarter ended March 31, 2025. ... General and administrative (G&A) expenses were $10.3 million for the quarter ended March 31, 2026, compared to $6.9 million for the quarter ended March 31, 2025. ... Net loss was $8.6 million for the quarter ended March 31, 2026, compared to $21.5 million for the quarter ended March 31, 2025.
Revenue was $26.5 million (primarily from Novo Nordisk collaboration), R&D expenses were $29.5 million, G&A expenses were $10.3 million, and net loss was $8.6 million. The net loss improved significantly from $21.5 million in Q1 2025, driven by higher collaboration revenue.
Added in current filing · view on EDGAR →
In March 2026, Septerna presented positive Phase 1 clinical results for SEP-631, its oral small molecule MRGPRX2 negative allosteric modulator (NAM), supporting advancement into Phase 2 development. SEP-631 was well tolerated, demonstrated a pharmacokinetic profile supportive of once-daily oral dosing and produced robust, dose-dependent suppression of icatibant-induced skin wheal formation. ... Septerna continues preparations to initiate a Phase 2b trial of SEP-631 in chronic spontaneous urticaria (CSU) in the second half of 2026 following completion of long-term toxicology studies.
Septerna disclosed positive Phase 1 data for SEP-631 in March 2026, showing good tolerability, once-daily dosing potential, and dose-dependent efficacy in suppressing skin wheal formation. The company plans to initiate a Phase 2b trial in chronic spontaneous urticaria in the second half of 2026, pending completion of long-term toxicology studies.
Added in current filing · view on EDGAR →
Revenue for the quarter ended March 31, 2026 included the amortization of $15.7 million of the $195.0 million from the upfront payment and $0.5 million from the achievement of $2.0 million in research milestones in addition to $10.3 million for research services associated with the collaboration.
Q1 2026 revenue of $26.5 million from the Novo Nordisk collaboration included $15.7 million in amortized upfront payment, $0.5 million from achieving $2.0 million in research milestones, and $10.3 million for research services. This represents a significant increase from $0.2 million in Q1 2025.
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Figures/quotes linked to EDGAR · Narrative written by AI · Jul 9, 2026 · How we verify