Seres Therapeutics(MCRB) - 2025 Q1 - Quarterly Results

Business Updates and Strategy Seres Therapeutics prioritizes SER-155 development, seeks partnerships, explores biotherapeutics for inflammatory diseases, and regained Nasdaq compliance SER-155 Program for Bloodstream Infection Prevention Seres prioritizes SER-155 for bloodstream infection prevention, preparing a Phase 2 study protocol after FDA feedback, and actively seeking a partner - Seres plans to submit a Phase 2 study protocol for SER-155 to the FDA in the coming weeks, following recent constructive feedback[1][3] - The planned Phase 2 study will be placebo-controlled, target 248 participants, and include an interim data analysis. A successful outcome could support advancing to a single Phase 3 study for registration[3][7] - Clinical results from the Phase 1b study showed a significant 77% relative risk reduction in bloodstream infections (BSIs)[1][17] - Seres is actively engaged in discussions to find a strategic partner to provide financial and other support for SER-155's development and commercialization[3][4] Development of Biotherapeutics for Inflammatory and Immune Diseases Seres explores biotherapeutics for inflammatory and immune diseases, leveraging SER-155 biomarker data for intestinal barrier and inflammation - Exploratory biomarker data from the SER-155 study reinforce its intended mechanisms, including promoting intestinal epithelial barrier integrity and reducing systemic inflammation, supporting potential use in inflammatory and immune diseases[6][8] - Seres presented data at the DDW conference identifying microbiome-based biomarkers for patient selection in clinical trials for ulcerative colitis, receiving a "Poster of Distinction" award[12] - The company is exploring options to advance its investigational live biotherapeutics in inflammatory and immune diseases, including ulcerative colitis and Crohn's disease[12] Recent Corporate Update Seres completed a 1-for-20 reverse stock split in April 2025 and regained Nasdaq listing compliance in May 2025 - On April 21, 2025, Seres implemented a 1-for-20 reverse stock split[9] - On May 6, 2025, Nasdaq confirmed that the company regained compliance with the Nasdaq Bid Price Requirement[9] Anticipated Upcoming Milestones Seres anticipates key milestones including SER-155 Phase 2 protocol submission, ASCO 2025 results, a Nestlé payment, and partnership updates - Submit SER-155 Phase 2 study protocol to the FDA in the coming weeks[12] - Present additional SER-155 clinical results at the ASCO 2025 conference (May 30 - June 3, 2025)[12] - Expect receipt of a $25 million installment payment from Nestlé in July 2025[12] - Provide updates regarding SER-155 partnership discussions[12] Q1 2025 Financial Results Seres reported Q1 2025 net income of $32.7 million from continuing operations, driven by a Nestlé payment and reduced operating expenses Financial Performance Summary Seres reported Q1 2025 net income of $32.7 million from continuing operations, driven by a $52.2 million gain on VOWST sale and reduced operating expenses Q1 2025 vs Q1 2024 Financial Highlights (Continuing Operations) | Financial Metric | Q1 2025 (in millions) | Q1 2024 (in millions) | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Net Income (Loss) | $32.7 | $(32.9) | +$65.6 | Primarily driven by $50M installment payment from Nestlé | | R&D Expenses | $11.8 | $19.5 | -$7.7 | Lower personnel expenses and platform investments | | G&A Expenses | $11.9 | $14.9 | -$3.0 | Lower personnel/contractor expenses and cost management | | Basic EPS | $3.76 | $(4.50) | +$8.26 | Reflects net income and share count changes | - The VOWST business has been classified under discontinued operations, with no ongoing activity in the current period[11] Cash Position and Runway Seres held $58.8 million in cash as of March 31, 2025, expecting to fund operations into Q1 2026 with an additional $25 million Nestlé payment - Cash and cash equivalents were $58.8 million as of March 31, 2025[13] - Current cash and the anticipated $25 million Nestlé payment are expected to fund operations into Q1 2026[13] Financial Statements Condensed consolidated financial statements detail Seres' Q1 2025 financial position, showing $164.2 million total assets and a shift to net income from continuing operations Condensed Consolidated Balance Sheets As of March 31, 2025, Seres' balance sheet shows total assets of $164.2 million, total liabilities of $113.7 million, and stockholders' equity of $50.5 million Balance Sheet Summary (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $58,849 | $30,793 | | Total current assets | $66,078 | $38,674 | | Total assets | $164,182 | $139,810 | | Total current liabilities | $31,323 | $41,222 | | Total liabilities | $113,717 | $126,026 | | Total stockholders' equity | $50,465 | $13,784 | Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) Seres reported Q1 2025 net income from continuing operations of $32.7 million, driven by a $52.2 million gain on VOWST sale, contrasting with a prior year loss Statement of Operations Summary (in thousands) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Total operating expenses | $27,236 | $34,438 | | Loss from operations | $(27,236) | $(34,438) | | Gain on sale of VOWST Business | $52,181 | $— | | Net income (loss) from continuing operations | $32,682 | $(32,903) | | Net (loss) from discontinued operations | $— | $(7,230) | | Net income (loss) | $32,682 | $(40,133) |