Metsera Inc(US:MTSR)2025-07-28 20:15Key Highlights Metsera reported significant progress in its clinical pipeline for obesity and metabolic diseases, with key data releases for its leading candidates MET-097i and MET-233i expected in late 2025. The company is well-capitalized with $530.9 million in cash, providing a financial runway into 2027 - The company has a strong cash position of $530.9 million, which is expected to fund operations into 20271 Upcoming Clinical Milestones | Candidate/Program | Milestone | Expected Timing | | :--- | :--- | :--- | | MET-097i | VESPER-1 & interim VESPER-3 data release | September 2025 | | MET-097i | Phase 3 initiation | Late 2025 | | MET-233i | 12-week monotherapy data | Late 2025 | | MET-233i + MET-097i | 12-week co-administration data | Year-end 2025 or early 2026 | | Oral Peptide Program | 4-week data for selected lead | Late 2025 | Pipeline Highlights and Upcoming Milestones Metsera is advancing a robust pipeline of injectable and oral therapies for obesity. Key programs like MET-097i (GLP-1 RA) and MET-233i (amylin analog) are progressing rapidly, with multiple clinical data readouts and a Phase 3 trial initiation scheduled for the second half of 2025. The company is also developing combination therapies and oral peptides to address the evolving treatment landscape - CEO Whit Bernard highlighted rapid progress across the pipeline, including positive Phase 1 data for MET-233i and accelerated enrollment for MET-097i studies3 MET-097i (Monthly GLP-1 RA) MET-097i, a once-monthly injectable GLP-1 receptor agonist, is on track for a major data release in September 2025 from its Phase 2b VESPER-1 and VESPER-3 trials. These results will inform the dosing for the global Phase 3 program, which is set to begin in late 2025 - MET-097i is a fully biased, monthly, ultra-long acting, subcutaneously injectable GLP-1 receptor agonist (RA)4 - Topline data from the VESPER-1 trial and interim data from the VESPER-3 trial are expected in September 20254 - The company is on track to initiate the Phase 3 program for MET-097i in late 20258 MET-233i (Monthly Amylin Analog) MET-233i, a once-monthly amylin analog, demonstrated class-leading Phase 1 results with significant weight loss and favorable tolerability. Its 19-day half-life enables a potential monthly combination therapy with MET-097i. Further 12-week monotherapy data is anticipated in late 2025 - Phase 1 results showed mean placebo-subtracted weight loss of up to 8.4% at Day 36 with placebo-like tolerability58 - The drug demonstrated a 19-day observed half-life, matching the pharmacokinetics of MET-097i for a potential monthly combination therapy8 - Topline 12-week data from the MET-233i monotherapy trial is expected in late 20258 MET-233i + MET-097i Combination The company is evaluating the co-administration of its monthly amylin analog (MET-233i) and GLP-1 RA (MET-097i). Topline 12-week data from this combination trial is expected by the end of 2025 or in early 2026 - Topline 12-week data from the co-administration trial of MET-233i and MET-097i is expected by year-end 2025 or in early 20266 Oral Peptide Platform Metsera is developing oral GLP-1 receptor agonists, MET-097o and MET-224o. The company plans to release preliminary four-week weight loss, tolerability, and pharmacokinetic data for the selected lead candidate in late 2025 - The oral platform includes MET-097o and MET-224o, which are oral, fully biased, ultra-long acting GLP-1 receptor agonists8 - Four-week topline data for the selected lead candidate is expected in late 20257 Additional Key Pipeline Programs The company is also advancing other candidates, including MET-034 (GIP RA) for combination therapy and MET-815, a prodrug of MET-097i with potential for quarterly dosing. Clinical milestones for these programs are expected in late 2025 and early 2026 - Preliminary data from the co-administration of MET-034 (GIP RA) with MET-097i are expected in late 20258 - IND-enabling studies are progressing for MET-815, a prodrug of MET-097i, with clinical trial initiation planned for year-end 2025 or early 20268 Second Quarter 2025 Financial Results For the second quarter of 2025, Metsera reported a strong cash position of $530.9 million, ensuring a financial runway into 2027. Operating expenses increased significantly, with R&D expenses rising to $60.5 million and G&A expenses to $11.5 million, driven by pipeline advancement and public company costs. This resulted in a net loss of $68.7 million for the quarter Financial Summary (Q2 2025 vs Q2 2024) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | R&D Expenses | $60.5M | $20.9M | | G&A Expenses | $11.5M | $5.6M | | Net Loss | $68.7M | $26.7M | - Cash and cash equivalents were $530.9 million as of June 30, 2025, which is estimated to be sufficient to fund operations into 20277 R&D Expenses Research and development expenses increased substantially to $60.5 million for the second quarter and $117.7 million for the first six months of 2025. The rise was primarily due to costs related to product candidate development, manufacturing, and increased personnel expenses R&D Expense Comparison (in millions) | Period | 2025 | 2024 | | :--- | :--- | :--- | | Three months ended June 30 | $60.5 | $20.9 | | Six months ended June 30 | $117.7 | $38.7 | - Increases were driven by product development costs for preclinical and clinical candidates, contract manufacturing, and higher personnel-related expenses, including stock-based compensation9 G&A Expenses General and administrative expenses for the second quarter and first six months of 2025 were $11.5 million and $20.1 million, respectively. The increase was mainly attributed to higher personnel-related costs and professional fees associated with operating as a public company G&A Expense Comparison (in millions) | Period | 2025 | 2024 | | :--- | :--- | :--- | | Three months ended June 30 | $11.5 | $5.6 | | Six months ended June 30 | $20.1 | $9.7 | - The increase was primarily due to personnel-related expenses (including stock-based compensation) and professional fees associated with being a public company10 Net Loss The company's net loss widened to $68.7 million for the second quarter and $145.3 million for the first six months of 2025. The higher loss reflects the significant ramp-up in R&D and G&A spending to advance its clinical pipeline Net Loss Comparison (in millions) | Period | 2025 | 2024 | | :--- | :--- | :--- | | Three months ended June 30 | $(68.7) | $(26.7) | | Six months ended June 30 | $(145.3) | $(46.6) | - Net cash used in operating activities for the six months ended June 30, 2025 was $113.3 million11 Financial Statements This section presents the unaudited condensed consolidated financial statements as of June 30, 2025, and for the three and six-month periods then ended. It includes the Balance Sheets and the Statement of Operations, providing a detailed view of the company's financial position and performance Condensed Consolidated Balance Sheets As of June 30, 2025, Metsera's balance sheet showed total assets of $639.7 million, a significant increase from $451.0 million at the end of 2024. This was driven by a rise in cash and cash equivalents to $530.9 million. Total liabilities stood at $190.4 million, and total stockholders' equity was $449.2 million Condensed Consolidated Balance Sheets (in thousands) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $530,919 | $352,447 | | Total current assets | $538,076 | $359,133 | | Total assets | $639,660 | $450,988 | | Liabilities and Stockholders' Equity | | | | Total current liabilities | $102,308 | $67,307 | | Total liabilities | $190,428 | $163,638 | | Total stockholders' equity (deficit) | $449,232 | $(253,507) | | Total liabilities and stockholders' equity | $639,660 | $450,988 | Condensed Consolidated Statement of Operations For the three months ended June 30, 2025, Metsera reported a net loss of $68.7 million, or ($0.66) per share, compared to a net loss of $26.7 million, or ($1.86) per share, for the same period in 2024. The increased loss was driven by a near tripling of R&D expenses and a doubling of G&A expenses Condensed Consolidated Statement of Operations (in thousands, except per share data) | | Three Months Ended June 30 | Six Months Ended June 30 | | :--- | :--- | :--- | :--- | :--- | | | 2025 | 2024 | 2025 | 2024 | | Research and development | $60,511 | $20,855 | $117,697 | $38,668 | | General and administrative | $11,482 | $5,643 | $20,085 | $9,718 | | Total operating expenses | $71,123 | $28,005 | $150,932 | $49,068 | | Loss from operations | $(71,123) | $(28,005) | $(150,932) | $(49,068) | | Net loss | $(68,715) | $(26,728) | $(145,303) | $(46,608) | | Net loss per share, basic and diluted | $(0.66) | $(1.86) | $(1.62) | $(3.31) |