Metsera Inc(MTSR) - 2025 Q1 - Quarterly Results

Report Overview Metsera's Q1 2025 performance highlights a successful IPO and steady progress toward its clinical milestones First Quarter 2025 Highlights Metsera reported strong Q1 2025 execution, a successful IPO securing funding into 2027, and progress on clinical milestones - Successfully completed a $316 million IPO in Q1 2025, with sufficient cash and cash equivalents of $588 million to fund operations into 2027[2][4] - The company is on track to deliver on key 2025 clinical milestones, including data releases for MET-233i, MET-097i, and other programs[1][4] Pipeline Highlights and Upcoming Milestones The company is advancing its clinical pipeline, with key data readouts expected for its injectable and oral programs in 2025 MET-097i: Injectable GLP-1 RA The Phase 2b program for the monthly injectable GLP-1 RA is progressing, with key data expected mid-2025 to inform a Phase 3 start - MET-097i is a fully biased, monthly, ultra-long acting GLP-1 receptor agonist[1][5] - The VESPER Phase 2b program consists of three trials (VESPER-1, -2, -3) to evaluate MET-097i's efficacy and tolerability[5] VESPER Phase 2b Program Overview | Trial | Population | Primary Endpoint | Expected Data Release | | :--- | :--- | :--- | :--- | | VESPER-1 | Obesity/overweight (no T2D) | Weight loss at 28 weeks | Mid-2025 | | VESPER-2 | Obesity/overweight with T2D | Weight loss at 28 weeks | Early 2026 | | VESPER-3 | Obesity/overweight (no T2D) | Weight loss with monthly doses | Year-end 2025 / Early 2026 | - Pending results from VESPER-1, the company plans to initiate a Phase 3 program in late 2025[5] MET-233i: Injectable Amylin Analog Phase 1 trials for the monthly injectable amylin analog are ongoing, with initial monotherapy and combination data expected in 2025 - MET-233i is a monthly, ultra-long acting, subcutaneously injectable amylin analog currently in Phase 1 trials[6][7] - Upcoming data readouts include preliminary 5-week monotherapy data in Q2 2025, followed by 12-week monotherapy and 5-week co-administration data in late 2025[6][7] Oral Peptide Platform (MET-097o & MET-224o) The oral drug pipeline is advancing with Phase 1 trials for two candidates starting mid-2025, with initial data expected by year-end - The oral GLP-1 RA program includes MET-097o and MET-224o[6][7] - Development of MET-097o has been accelerated due to promising preclinical oral exposure data[7] - Phase 1 trials for both oral candidates are planned to start in mid-2025, with preliminary 4-week data for the selected lead candidate expected in late 2025[6][7] Financial Results The company's Q1 2025 financials show a widened net loss due to increased R&D spending, offset by a strong cash position post-IPO Financial Performance Summary Q1 2025 net loss grew to $76.6 million on higher R&D costs, while the post-IPO cash balance of $588.3 million ensures a runway into 2027 - Cash and cash equivalents increased to $588.3 million as of March 31, 2025, projecting a financial runway into 2027[8] Q1 Financial Highlights | Financial Metric (Q1) | 2025 | 2024 | Change Driver | | :--- | :--- | :--- | :--- | | R&D Expenses | $57.2M | $17.8M | Increased preclinical, clinical, and manufacturing costs | | G&A Expenses | $8.6M | $4.1M | Increased personnel-related expenses | | Net Loss | $76.6M | $19.9M | Higher operating expenses and change in fair value of contingent consideration | Corporate Updates The company is advancing its manufacturing collaboration with Amneal and has strengthened its leadership team and board Manufacturing Updates The strategic manufacturing partnership with Amneal is on track, with new dedicated facilities under construction in India - The strategic collaboration with Amneal is progressing, with construction of new facilities in India featuring Metsera-dedicated lines for peptide synthesis and sterile fill-finish manufacturing[12] - Metsera plans to work with Amneal to optimize its commercial manufacturing footprint across Amneal's US and global network[12] Organizational Updates Metsera strengthened its governance and legal functions with key appointments to its Board of Directors and executive team - Jon P. Stonehouse, CEO of BioCryst Pharmaceuticals, was appointed to the Board of Directors as a Class III director and a member of the Audit Committee[13] - Matthew Lang was appointed as Chief Legal Officer and Secretary, bringing experience from roles at Lyell Immunopharma and Myovant Sciences[14] Financial Statements The condensed consolidated financial statements reflect a strengthened balance sheet and increased operating expenses for Q1 2025 Condensed Consolidated Balance Sheets The balance sheet shows total assets grew to $690.7 million and stockholders' equity became positive, driven by IPO proceeds Condensed Consolidated Balance Sheets | (in thousands) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Total Current Assets | $594,738 | $359,133 | | Cash and cash equivalents | $588,335 | $352,447 | | Total Assets | $690,695 | $450,988 | | Total Current Liabilities | $90,741 | $67,307 | | Total Liabilities | $185,308 | $163,638 | | Total Stockholders' Equity (Deficit) | $505,387 | ($253,507) | Condensed Consolidated Statement of Operations The Q1 2025 statement of operations reveals a net loss of $76.6 million, widened by a significant year-over-year rise in R&D expenses Condensed Consolidated Statement of Operations | (in thousands, except per share data) | For the three months ended March 31, 2025 | For the three months ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $57,185 | $17,813 | | General and administrative | $8,603 | $4,075 | | Total operating expenses | $79,808 | $21,063 | | Loss from operations | ($79,808) | ($21,063) | | Net loss | ($76,588) | ($19,880) | | Net loss per share, basic and diluted | ($1.03) | ($1.44) |