Septerna Picks TSHR Candidate, Plans Phase 1 in 2027

The Tip Desk · November 12, 2026 · 3 min read

Cash, cash equivalents and marketable securities reached $565.2 million as of September 30, 2026, and the company said the position is expected to fund operations at least into mid-2029.

Septerna, Inc. (SEPN), a clinical-stage biotechnology company developing oral GPCR medicines, selected SEP-204 as its oral TSHR negative allosteric modulator development candidate for Graves’ disease and thyroid eye disease and said it anticipates starting a Phase 1 trial in healthy volunteers in the first quarter of 2027.

The selection, announced with the American Thyroid Association annual meeting, marked a step beyond the company’s prior posture of progressing toward development-candidate selection. Preclinical data presented at ATA showed SEP-204 potently and selectively inhibited TSHR, restored normal thyroid hormone T4 levels and reduced thyroid enlargement and orbital proptosis in Graves’ disease animal models. The company said SEP-204 was generally well tolerated in 28-day GLP toxicology studies and showed a pharmacokinetic profile it anticipated would support once-daily oral dosing in humans.

SEP-479, an oral PTH1R agonist for hypoparathyroidism, remained in a Phase 1 single-ascending and multiple-ascending dose study in healthy volunteers, with data still expected in the first quarter of 2027. Chief Executive Officer Jeffrey Finer said the company is building momentum across the portfolio with that upcoming SEP-479 milestone and the SEP-204 selection.

Revenue for the quarter ended September 30, 2026 was $18.9 million, down from $26.7 million in the prior quarter and $26.5 million in the quarter before that. The Novo Nordisk collaboration accounted for $2.7 million of amortization of the $195.0 million upfront payment, $5.2 million from research milestones and $11.0 million for research services.

Novo Nordisk recently assumed responsibility for a development candidate delivered by Septerna’s research team and initiated IND-enabling toxicology studies. The company said it has achieved a total of $13 million in research milestones under the collaboration, which began in July 2025 and covers oral small-molecule programs in obesity, type 2 diabetes and other cardiometabolic diseases.

Research and development expenses were $36.6 million, compared with $24.3 million a year earlier. General and administrative expenses were $9.6 million. Net loss was $26.6 million, or $0.57 a share, versus net income of $8.2 million, or $0.18 a share, in the year-ago quarter, which included a $12.5 million gain on sale of a non-financial asset.

Cash, cash equivalents and marketable securities were $565.2 million as of September 30, 2026, versus $516.5 million at June 30, 2026 and $522.1 million at March 31, 2026. Septerna said the cash position is expected to support operations at least into mid-2029.

SEP-631, an oral MRGPRX2 NAM, continues to be evaluated in capital-efficient, signal-finding clinical studies in mast cell-driven diseases after positive Phase 1 results reported in March 2026. The company also continues wholly owned discovery programs, including a PTH1R agonist for osteoporosis. In August 2026 it appointed Rajiv Patni, M.D., as Chief Medical Officer, following the first-quarter announcement that Chief Medical Officer Jae Kim was departing.