Septerna Inc. (SEPN) is a clinical-stage biotechnology company revolutionizing drug discovery through its proprietary Native Complex Platform™, which unlocks the full therapeutic potential of G protein-coupled receptors (GPCRs). Headquartered in South San Francisco, California, Septerna leverages cutting-edge technology to develop oral small molecule therapies targeting GPCRs, addressing significant unmet medical needs in endocrinology, immunology and inflammation, and metabolic diseases.
Founded by leading experts in biochemistry, structural biology, and pharmacology, Septerna is driven by a mission to transform patient care with novel, disease-modifying therapies. The company’s robust pipeline includes innovative programs like SEP-786, an oral treatment for hypoparathyroidism currently in Phase 1 clinical trials, and SEP-631, targeting chronic spontaneous urticaria. With a strong financial foundation and a commitment to advancing life-changing medicines, Septerna is poised to redefine the future of GPCR-targeted drug development.
Transformative Technology Driving a Robust Pipeline
Septerna’s Native Complex Platform™ offers a breakthrough in GPCR-targeted drug discovery by enabling precise control over GPCR pharmacology. This platform has resulted in a diverse pipeline targeting key therapeutic areas, including endocrinology, immunology and inflammation, and metabolic diseases. Leading the pipeline is SEP-786, an oral small molecule agonist targeting the parathyroid hormone 1 receptor (PTH1R) for hypoparathyroidism. Preclinical data demonstrate its potential to provide full-day calcium control with a disease-modifying, convenient oral therapy. In September 2024, Septerna initiated a Phase 1 clinical trial for SEP-786, with results expected in mid-2025.
Beyond SEP-786, Septerna’s pipeline includes SEP-631, a negative allosteric modulator (NAM) targeting MRGPRX2 for chronic spontaneous urticaria and other mast cell-driven diseases. Another promising program focuses on developing thyroid-stimulating hormone receptor (TSHR) NAMs for Graves’ disease and thyroid eye disease (TED), demonstrating the ability to reverse hyperthyroidism and address TED-related symptoms in preclinical models. Additionally, Septerna’s Incretin Receptor Program is advancing next-generation therapies for metabolic diseases, including obesity and type 2 diabetes, with compounds showing significant glucose control and weight loss in preclinical studies.
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Strong Financial Position to Fuel Growth
Following its upsized initial public offering in October 2024, Septerna raised $302.6 million in net proceeds, resulting in a cash balance of $137.5 million as of September 30, 2024. These resources are projected to sustain the company’s operations into the second half of 2027, supporting clinical trials, pipeline expansion, and strategic initiatives. With a prudent approach to operational efficiency, Septerna reported research and development expenses of $17.8 million and general and administrative expenses of $4.9 million in Q3 2024, reflecting its commitment to advancing its clinical programs while maintaining financial discipline.
Clinical and Strategic Milestones
The successful initiation of clinical trials for SEP-786 marked Septerna’s transition to a clinical-stage company, a significant milestone celebrated alongside its public market debut. The company’s strategic hiring, including the appointment of Jae Kim, M.D., as Chief Medical Officer, strengthens its ability to navigate the clinical landscape effectively. Septerna’s commitment to early biomarker readouts and disease-modifying therapies underscores its focus on accelerating the path to market for its groundbreaking treatments.
Addressing High-Value Therapeutic Markets
GPCRs represent one of the most important target classes in drug discovery, with significant implications for a wide range of diseases. Septerna’s programs address high-value markets, such as hypoparathyroidism, mast cell-driven diseases, metabolic disorders, and autoimmune conditions. The unmet need in these areas provides substantial market opportunities, positioning Septerna to deliver innovative solutions that could transform patient care.
Positive Outlook and Market Potential
With its pioneering platform, a deep and diverse pipeline, and a strong financial foundation, Septerna is well-equipped to achieve its strategic goals. Analysts have noted the company’s potential to redefine GPCR drug development, leveraging its Native Complex Platform™ to produce best-in-class oral therapies that target previously inaccessible GPCRs. Septerna’s market potential is further underscored by its ability to address critical gaps in treatment options across therapeutic areas.
A Leader in GPCR Drug Discovery
Septerna Inc. is poised to become a transformative player in the biopharmaceutical industry. Its innovative approach to GPCR-targeted therapies, strong clinical and financial trajectory, and commitment to addressing unmet medical needs highlight its potential for sustained growth and long-term value creation. For investors seeking exposure to cutting-edge drug discovery with substantial market opportunities, Septerna offers a compelling and bullish investment case.
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