Septerna, Inc. (SEPN), a biotechnology company pioneering small molecule therapies targeting G protein-coupled receptors or GPCRs, will present at the Jefferies Global Healthcare Conference on June 5, 2025, at 3:45 p.m. ET in New York.
The company is preparing to initiate a Phase 1 trial of SEP-631, a selective oral MRGPRX2 negative allosteric modulator or NAM, in the third quarter of 2025.
SEP-631 is being developed for mast cell diseases such as chronic spontaneous urticaria. The upcoming trial will assess safety, tolerability, pharmacokinetics, and pharmacodynamics using an icatibant skin challenge.
Septerna is also advancing a next-generation oral PTH1R agonist for hypoparathyroidism.
The program features compounds with distinct chemical structures and pharmacokinetics optimized for once- or twice-daily dosing, aiming for full-day calcium control.
Candidate selection remains on track for the second half of 2025.
The company continues progress on its TSHR NAM program for Graves' disease and thyroid eye disease, with lead optimization ongoing toward development candidate nomination.
On May 14, 2025, Septerna announced a global collaboration with Novo Nordisk to discover and develop oral small molecule therapies for obesity, type 2 diabetes, and cardiometabolic diseases.
The deal includes more than $200 million in upfront and near-term milestones, with total potential value up to $2.2 billion.
Septerna is eligible for tiered royalties on global sales and retains a one-time profit-sharing option for one program. Novo Nordisk will fully fund research and development for all partnered programs.
Q1 Performance:
The company reported a net loss of $21.5 million for the first quarter of 2025, compared to $14.2 million in the same period last year.
R&D expenses rose to $19.3 million from $13.2 million in the first quarter 2024, reflecting pipeline expansion and preclinical activities.
General and administrative expenses increased to $6.9 million, up from $2.7 million, driven by growth and operational scale-up.
Cash Position:
Septerna ended the quarter with $398.2 million in cash, cash equivalents, and marketable securities. The recent Novo Nordisk partnership is expected to significantly extend its cash runway beyond early 2028. Updated financial guidance will be provided following the transaction closing.
Currently, SEPN is trading at $9.91, up by 7.13 percent on the Nasdaq.
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