Septerna, Inc.
21.94-0.38 (-1.7%)
Oct 29, 4:00:01 PM EDT · NasdaqGM · SEPN · USD
Key Stats
Market Cap
978.20MP/E (TTM)
-Basic EPS (TTM)
-7.58Dividend Yield
0%Recent Filings
8-K
Septerna appoints biotech leader to board
Septerna expanded its board to eight members on September 25, 2025, appointing Keith Gottesdiener, M.D., a biotech veteran with over 30 years advancing therapies from discovery to approval, as a Class I director. Effective September 26, he joins the Compensation Committee and chairs the new R&D Committee, bringing expertise in regulatory strategy and clinical development to guide Septerna's GPCR pipeline, including the PTH1R program for hypoparathyroidism. His addition bolsters oversight at this pivotal stage. Yet risks in clinical trials persist.
8-K
Septerna pipeline updates
Septerna updated its corporate presentation on September 3, 2025, highlighting pipeline progress in GPCR-targeted oral small molecules. SEP-631's Phase 1 trial in healthy volunteers kicked off in August 2025, with initial safety and efficacy data due in the first half of 2026; SEP-479 advances toward Phase 1 initiation then too, after preclinical success normalizing calcium in hypoparathyroidism models. Backed by a Novo Nordisk collaboration yielding $195 million upfront, cash funds operations into 2029. Yet risks linger in clinical translation.
8-K
Septerna doses first in SEP-631 trial
Septerna kicked off dosing in its Phase 1 trial of SEP-631, an oral small molecule targeting MRGPRX2 to curb mast cell activation in chronic spontaneous urticaria and related diseases. The randomized, placebo-controlled study in up to 150 healthy volunteers assesses safety, tolerability, pharmacokinetics, and pharmacodynamics via single- and multiple-ascending doses. This advances Septerna's GPCR platform toward oral options for unmet needs. Trial enrollment proceeds amid clinical risks.
8-K
Septerna advances pipeline, bolsters cash
Septerna reported Q2 2025 net loss of $24.8 million, up from $16.4 million last year, as R&D expenses climbed to $22.2 million amid pipeline advances. The Novo Nordisk collaboration kicked off July 1 with a $195 million upfront payment, extending cash runway into 2029. Key moves include selecting a PTH1R agonist candidate this quarter for hypoparathyroidism and launching SEP-631's Phase 1 trial soon for mast cell diseases. Liz Bhatt steps up to President, fueling growth. Clinical timelines hinge on preclinical success.
10-Q
Q2 FY2025 results
Septerna's Q2 FY2025 results showed revenue dipping to $0.1M from $0.4M y/y, driven by winding down Vertex research services, while R&D expenses climbed 47.6% to $22.2M y/y on pipeline advances like SEP-631 and PTH1R agonists, pushing operating loss to $29.0M from $18.1M. Net loss widened to $24.8M or $0.56/share from $16.4M or $7.03/share y/y, reflecting higher stock-based comp and G&A costs post-IPO, yet interest income surged to $4.2M from $1.5M on a larger cash pile. Cash burn hit $43.6M YTD, leaving $379.2M in cash and marketable securities at quarter-end, bolstered by the recent $195M Novo Nordisk upfront for GPCR metabolic programs. No debt weighs on the balance sheet. Regulatory hurdles in biotech pipelines loom large.
ALT
Altimmune, Inc.
4.00-0.06
CRNX
Crinetics Pharmaceuticals, Inc.
42.90+0.84
GPCR
Structure Therapeutics Inc.
29.57+0.62
LPCN
Lipocine Inc.
2.69-0.06
LTRN
Lantern Pharma Inc.
3.82-0.16
MNPR
Monopar Therapeutics Inc.
84.16+4.24
MTSR
Metsera, Inc.
52.21-0.21
SEPSF
ASEP Medical Holdings Inc.
0.39+0.00
TCRT
Alaunos Therapeutics, Inc.
2.72+0.03
TERN
Terns Pharmaceuticals, Inc.
8.02-0.57