Executive Summary This section summarizes Septerna's clinical advancements, financial strengthening, and key leadership changes Key Business Progress and Milestones Septerna is actively advancing its clinical pipeline, initiating a Phase 1 trial for SEP-631 for mast cell diseases and progressing its PTH1R agonist program towards development candidate selection and a Phase 1 trial in early 2026 - Initiating Phase 1 Trial for SEP-631, MRGPRX2 NAM Program, for Mast Cell Diseases in Q3 2025 237 - Advancing selection of a next-generation oral small molecule PTH1R Agonist for clinical development in Q3 2025, with a Phase 1 trial planned for H1 2026 237 Financial Outlook and Strategy The company's financial position has been significantly bolstered by the effective collaboration with Novo Nordisk, extending its cash runway well into 2029 - Updated cash runway expected to support operating plans at least into 2029, bolstered by the Novo Nordisk collaboration 2314 Corporate Overview and Program Updates This section covers Septerna's leadership, Novo Nordisk collaboration, and pipeline program advancements Leadership Update Septerna announced the promotion of Liz Bhatt, MS, MBA, to President, effective August 1, 2025, recognizing her instrumental role in strategic partnerships and company growth - Liz Bhatt, COO, promoted to President, effective August 1, 2025 6 - Ms. Bhatt was instrumental in securing the multi-billion-dollar strategic partnership with Novo Nordisk and guiding Septerna through a successful IPO in 2024 9 Collaboration with Novo Nordisk The global collaboration and license agreement with Novo Nordisk became effective on July 1, 2025, initiating joint R&D efforts for cardiometabolic diseases and resulting in a $195 million upfront payment to Septerna - Global collaboration and license agreement with Novo Nordisk became effective on July 1, 2025, focusing on oral small molecule therapies for obesity, type 2 diabetes, and other cardiometabolic diseases 7 - Septerna received a $195 million upfront payment in July 2025 in connection with the agreement's effectiveness 7 Pipeline Program Updates Septerna provided updates on its key pipeline programs, including the initiation of a Phase 1 trial for SEP-631, progress towards a development candidate for its PTH1R agonist, and advancement of its TSHR NAM and discovery programs SEP-631 MRGPRX2 NAM Program Septerna is initiating a Phase 1 clinical trial for SEP-631, an oral small molecule for mast cell diseases, in healthy volunteers during Q3 2025 - Initiating a Phase 1 clinical trial for SEP-631 in healthy volunteers in Q3 2025 to assess safety, tolerability, pharmacokinetics, and pharmacodynamics 7 - SEP-631 is a selective oral small molecule MRGPRX2 negative allosteric modulator (NAM) for mast cell diseases, including chronic spontaneous urticaria 7 PTH1R Agonist Program The PTH1R agonist program for hypoparathyroidism is on track to select a next-generation development candidate in Q3 2025, with a Phase 1 clinical trial planned for H1 2026 - Tracking towards selection of a next-generation PTH1R agonist development candidate in Q3 2025 7 - Plans to commence a Phase 1 clinical trial in H1 2026, following successful completion of preclinical development activities 7 - Goal is to provide full-day calcium control in hypoparathyroidism patients 7 TSHR NAM Program Septerna is making progress on its TSHR NAM program, moving multiple lead compounds closer to development candidate selection for Graves' disease and thyroid eye disease - Progressing multiple lead compounds closer to development candidate selection for a potential disease-modifying oral treatment for Graves' disease and thyroid eye disease 7 Discovery Programs The company continues to advance its discovery-stage programs across multiple therapeutic areas, leveraging its Native Complex Platform™ - Advancing discovery-stage programs utilizing its Native Complex Platform™ across multiple therapeutic areas 7 Second Quarter 2025 Financial Results This section details Septerna's Q2 2025 financial results, including key highlights, statements of operations, and balance sheet Summary Financial Highlights Septerna reported a net loss of $24.8 million for Q2 2025, with increased R&D and G&A expenses compared to the prior year, while its cash position was strengthened by the Novo Nordisk upfront payment Key Financial Highlights (Q2 2025 vs. Q2 2024) | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | Change (YoY) | | :----------------------- | :------------------ | :------------------ | :------------ | | Cash, cash equivalents, and marketable securities (as of June 30) | $379.2 | N/A | N/A | | R&D Expenses | $22.2 | $15.0 | +48.0% | | G&A Expenses | $6.9 | $3.4 | +102.9% | | Net Loss | $(24.8) | $(16.4) | +51.2% | - Cash, cash equivalents, and marketable securities totaled $379.2 million as of June 30, 2025. Following receipt of the $195.0 million upfront payment from Novo Nordisk in July, Septerna now expects its cash runway to extend at least into 2029 14 Condensed Statements of Operations The condensed statements of operations show a net loss of $24.8 million for the three months ended June 30, 2025, an increase from $16.4 million in the prior year, driven by higher R&D and G&A expenses Condensed Statements of Operations (Unaudited, In thousands) | | Three Months Ended June 30, | | Six Months Ended June 30, | | :------------------------------------------ | :--- | :--- | :--- | :--- | | | 2025 | 2024 | 2025 | 2024 | | Revenue | $119 | $370 | $338 | $687 | | Operating expenses: | | | | | | Research and development | 22,188 | 15,035 | 41,459 | 28,188 | | General and administrative | 6,909 | 3,400 | 13,767 | 6,054 | | Total operating expenses | 29,097 | 18,435 | 55,226 | 34,242 | | Loss from operations | (28,978) | (18,065) | (54,888) | (33,555) | | Interest and other income, net | 4,140 | 1,515 | 8,574 | 2,746 | | Benefit for income taxes | — | 109 | — | 202 | | Net loss attributable to common stockholders | $(24,838) | $(16,441) | $(46,314) | $(30,607) | | Net loss per share attributable to common stockholders, basic and diluted | $(0.56) | $(7.03) | $(1.05) | $(13.40) | | Weighted-average shares outstanding, basic and diluted | 44,165,168 | 2,337,585 | 44,051,918 | 2,284,414 | Condensed Balance Sheets As of June 30, 2025, Septerna reported total assets of $415.2 million and total stockholders' equity of $377.6 million, with cash, cash equivalents, and marketable securities at $379.2 million Condensed Balance Sheets (Unaudited, In thousands) | | June 30, | | December 31, | | :------------------------------------------ | :--- | :--- | :--- | :--- | | | 2025 | | 2024 | | Cash, cash equivalents and marketable securities | $379,194 | | $420,789 | | Working capital | 319,014 | | 343,975 | | Total assets | 415,231 | | 456,554 | | Total liabilities | 37,674 | | 36,507 | | Additional paid-in capital | 542,024 | | 538,321 | | Accumulated deficit | (164,688) | | (118,374) | | Total stockholders' equity | 377,557 | | 420,047 | About Septerna This section describes Septerna's company profile, Native Complex Platform™, and GPCR drug discovery focus Company Profile and Platform Septerna is a biotechnology company focused on G protein-coupled receptor (GPCR) drug discovery, utilizing its proprietary Native Complex Platform™ to develop oral small molecule therapies across endocrinology, immunology and inflammation, and metabolic diseases - Septerna, Inc. is a biotechnology company pioneering a new era of GPCR drug discovery 11 - Utilizes its proprietary Native Complex Platform™ to discover and develop a deep pipeline of oral small molecule product candidates 11 - Initial therapeutic areas of focus include endocrinology, immunology and inflammation, and metabolic diseases 11 Forward-Looking Statements This section outlines disclaimers for forward-looking statements, emphasizing risks and uncertainties for future results Disclaimer and Risk Factors This section serves as a disclaimer for forward-looking statements, highlighting that actual results may differ materially due to various risks and uncertainties, including those related to clinical trials, regulatory approvals, intellectual property, and economic conditions - The press release contains forward-looking statements regarding Septerna's beliefs and expectations, including program advancements, clinical trial initiations, and financial outlook 12 - These statements are subject to risks, uncertainties, and important factors that may cause actual events or results to differ materially 13 - Risks include uncertainties related to the Novo Nordisk collaboration, product candidates entering clinical trials, regulatory approvals, clinical development outcomes, intellectual property, and general economic conditions 13
Septerna, Inc.(SEPN) - 2025 Q2 - Quarterly Results