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Septerna Provides Corporate Overview and Reports Fourth Quarter and Full Year 2024 Financial Results
Preclinical Work Advancing with Plans to Select a Next-Generation Oral Small Molecule PTH1R Agonist to Accelerate Toward the Clinic Later This Year Phase 1
About this update from Septerna, Inc.
[{"type":"text","content":"Preclinical Work Advancing with Plans to Select a Next-Generation Oral Small Molecule PTH1R Agonist to Accelerate Toward the Clinic Later This Year Phase 1 Trial for SEP-631, MRGPRX2 NAM Program for Mast Cell Diseases, Expected to Initiate in 2025 Well-Capitalized with $420.8M Balance Sheet as of YE 2024 to Support Operating Runway into Early 2028 SOUTH SAN FRANCISCO, Calif., March 27, 2025 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today provided a corporate overview complete with upcoming milestones and reported fourth quarter and full year 2024 financial results. “Our Native Complex Platform™ continues to produce a deep pipeline of oral small molecule programs,” said Jeffrey Finer, M.D., Ph.D., chief executive officer and co-founder of Septerna. “Following the recent decision to discontinue our SEP-786 program, we remain focused on the opportunity to transform treatment for patients with hypoparathyroidism and are rapidly advancing multiple promising next-generation PTH1R agonists with the potential to select a next-generation candidate to advance toward the clinic later this year. In addition, SEP-631, our selective MRGPRX2 NAM for mast cell diseases, is on track to enter the clinic this year. We also continue to make good progress with our TSHR program for Graves’ disease and thyroid eye disease, as well as our single- and multi-acting incretin receptor agonist programs for metabolic diseases. With an experienced team, powerful platform and strong balance sheet, we believe we are well positioned to execute on our mission to develop multiple impactful GPCR medicines.” Corporate Overview and Anticipated Milestones PTH1R Agonist Program: In February 2025, Septerna discontinued its Phase 1 clinical trial of SEP-786, an oral small molecule agonist of the parathyroid hormone 1 receptor (PTH1R) in development for hypoparathyroidism, following the observation of two unanticipated events of elevated unconjugated bilirubin in the multiple ascending dose (MAD) portion of the trial. The Grade 3 bilirubin elevations were reversible, without elevations in ALT, AST, and GGT liver enzyme levels and without liver injury, cholestasis or hemolysis. Non-clinical studies are underway to investigate the underlying mechanism of the observed e...