Septerna, Inc.(SEPN) - 2025 Q1 - Quarterly Results

Business Highlights and Corporate Overview Septerna announced a landmark collaboration with Novo Nordisk, advanced its pipeline, and significantly extended its cash runway Key Business Updates and Milestones Septerna announced a landmark collaboration with Novo Nordisk, advanced its pipeline, and significantly extended its cash runway - Announced a global collaboration with Novo Nordisk to develop oral small molecules for metabolic diseases, with potential milestone payments exceeding $2.2 billion[2] - On track to select a next-generation oral small molecule PTH1R agonist candidate to advance toward the clinic by the end of 2025[2][3] - Expects to initiate a Phase 1 clinical trial for SEP-631, a program for mast cell diseases, in the third quarter of 2025[2][3] - Ended Q1 2025 with $398.2 million in cash, cash equivalents, and marketable securities. The Novo Nordisk collaboration is expected to significantly extend the prior cash runway guidance of early 2028[2] Pipeline Program Updates Septerna is advancing its wholly-owned pipeline, including PTH1R and SEP-631 programs, with key milestones expected in 2025 - PTH1R Agonist Program: Plans to select a next-generation candidate for hypoparathyroidism by the end of 2025, with compounds showing favorable PK profiles for potential once- or twice-daily dosing[6] - SEP-631 MRGPRX2 NAM Program: A Phase 1 clinical trial for this oral small molecule, targeting mast cell diseases, is anticipated to begin in Q3 2025[6] - TSHR NAM Program: The company is progressing several lead compounds designed as a disease-modifying treatment for Graves' disease and thyroid eye disease towards candidate selection[6] Collaboration Agreement with Novo Nordisk Septerna announced a global collaboration with Novo Nordisk for cardiometabolic diseases, securing over $200 million in upfront payments and R&D funding - The collaboration will initially focus on four R&D programs for small molecule therapies directed to GPCR targets like GLP-1, GIP, and glucagon receptors[6] Financial Terms of the Novo Nordisk Collaboration | Term | Details | | :--- | :--- | | Total Potential Value | Approx. $2.2 billion in upfront, research, development, and commercial milestones | | Upfront & Near-Term Payments | Over $200 million | | Royalties | Tiered royalties on global net sales of marketed products | | R&D Funding | Novo Nordisk will cover all R&D expenses for partnered programs | | Opt-in Right | Septerna can opt-in to a worldwide profit-share for one program in lieu of milestones and royalties | First Quarter 2025 Financial Results Septerna reported a net loss of $21.5 million in Q1 2025, driven by increased expenses, while maintaining a strong cash position significantly bolstered by the Novo Nordisk collaboration Financial Performance Summary Septerna reported a $21.5 million net loss in Q1 2025 due to increased expenses, maintaining a strong $398.2 million cash position extended by the Novo Nordisk deal - Cash, cash equivalents, and marketable securities totaled $398.2 million as of March 31, 2025[11] - The upfront payment from the Novo Nordisk collaboration is expected to significantly extend the prior cash runway guidance of early 2028[11] Q1 2025 vs. Q1 2024 Financial Comparison (In millions) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | R&D Expenses | $19.3 | $13.2 | | G&A Expenses | $6.9 | $2.7 | | Net Loss | $21.5 | $14.2 | Condensed Statements of Operations Septerna's Q1 2025 revenue was $0.2 million, resulting in a $21.5 million net loss, primarily due to increased operating expenses Condensed Statements of Operations (Unaudited, In thousands, except per share data) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Revenue | $219 | $317 | | Research and development | $19,271 | $13,153 | | General and administrative | $6,858 | $2,654 | | Total operating expenses | $26,129 | $15,807 | | Loss from operations | ($25,910) | ($15,490) | | Net loss | ($21,476) | ($14,166) | | Net loss per share, basic and diluted | ($0.49) | ($6.35) | Condensed Balance Sheets As of March 31, 2025, Septerna reported total assets of $434.0 million, with cash and equivalents at $398.2 million, and stockholders' equity at $400.3 million Condensed Balance Sheets (Unaudited, In thousands) | Metric | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $398,247 | $420,789 | | Total assets | $434,020 | $456,554 | | Total liabilities | $33,754 | $36,507 | | Total stockholders' equity | $400,266 | $420,047 | Company Information and Forward-Looking Statements Septerna is a biotechnology company focused on GPCR drug discovery, with forward-looking statements highlighting future collaborations, pipeline development, and financial projections subject to inherent risks About Septerna Septerna is a biotechnology company leveraging its Native Complex Platform™ for GPCR drug discovery, focusing on oral small molecule candidates across multiple therapeutic areas - The company's core technology is its proprietary Native Complex Platform™ for GPCR drug discovery[8] - Focuses on developing oral small molecule product candidates in three main therapeutic areas: endocrinology, immunology and inflammation, and metabolic diseases[8] Forward-Looking Statements Forward-looking statements cover the Novo Nordisk collaboration, pipeline development, and financial projections, subject to risks detailed in SEC filings - Forward-looking statements pertain to the Novo Nordisk collaboration, pipeline development, clinical trial timing, platform potential, and financial runway[9] - These statements involve significant risks and uncertainties, and actual results may differ materially from expectations[10] - The company directs readers to the 'Risk Factors' section of its Annual Report on Form 10-K for a more detailed description of these risks[10]