Septerna (SEPN) investor relations material

Key presentations and announcements

• Highlighted two lead programs: SEP-479, an oral small molecule for hypoparathyroidism, and SEP-631, a negative allosteric modulator targeting mast cell diseases, both advancing in clinical trials.

• SEP-479 recently began a phase I trial, with results expected late this year or early next; SEP-631 showed promising phase I data and is moving to phase II for chronic spontaneous urticaria.

• Additional pipeline includes a TSH receptor program for Graves' disease and incretin receptor agonists partnered with Novo, with further updates anticipated later in the year.

• The Native Complex Platform enables novel GPCR drug discovery, allowing structural biology at scale and identification of new binding pockets.

• Financially well-capitalized, with a cash runway into 2029.

Clinical and scientific insights

• SEP-479 demonstrated potent, selective oral activity, with preclinical models supporting once-daily dosing and a favorable safety profile; phase I focuses on safety, PK, and translational markers.

• SEP-631’s unique mechanism locks the receptor in an inactive state, with phase I showing strong safety, PK, and efficacy in a human skin challenge model.

• Plans for SEP-631 include phase II studies in urticaria and exploration of other mast cell-related indications such as atopic dermatitis and asthma.

• TSH receptor program uses a similar negative allosteric modulator approach for Graves' disease, with a development candidate expected later this year.

Industry context and strategic outlook

• The platform’s ability to reconstitute functional GPCRs outside cells enables rapid structural analysis and compound screening, providing a competitive edge in early drug discovery.

• Discovery of novel and cryptic binding pockets has led to breakthroughs in small molecule agonists and allosteric modulators for peptide GPCRs.

• The company’s strategy targets well-validated GPCRs with early clinical readouts, aiming for efficient development and de-risked pipelines.

• Collaboration with Novo on incretin receptor agonists is progressing well, expanding the reach of the platform.