Core Insights - Metsera, Inc. is making significant progress in its clinical pipeline for obesity and metabolic diseases, with key data releases and clinical milestones expected in the coming years [2][3][4] Pipeline Highlights and Upcoming Milestones - MET-097i: Data from VESPER-1 and interim VESPER-3 trials are expected to be released in September 2025, with Phase 3 initiation on track for late 2025 [4][6] - MET-233i: This once-monthly amylin analog has shown promising Phase 1 results, including an 8.4% weight loss over five weeks and a 19-day half-life, with 12-week monotherapy data anticipated in late 2025 [5][6] - Co-administration data for MET-233i and MET-097i is expected by the end of 2025 or early 2026 [8] - Oral peptide programs are progressing, with four-week data for selected leads expected in late 2025 [9] Financial Overview - As of June 30, 2025, the company reported cash and cash equivalents of $530.9 million, an increase from $352.4 million at the end of 2024, providing a runway into 2027 [9][18] - Research and development expenses for Q2 2025 were $60.5 million, up from $20.9 million in Q2 2024, driven by product candidate development costs [10][20] - General and administrative expenses for Q2 2025 were $11.5 million, compared to $5.6 million in Q2 2024, primarily due to personnel-related expenses [11][20] - The net loss for Q2 2025 was $68.7 million, compared to $26.7 million in Q2 2024, reflecting increased operating expenses [12][20]

Core Insights - Metsera, Inc. announced positive topline data from the Phase 1 clinical trial of MET-233i, showing up to 8.4% mean placebo-subtracted weight loss at Day 36, supporting its potential as a once-monthly monotherapy and in combination with MET-097i [1][2][4] - The trial demonstrated favorable tolerability with no safety signals, indicating a promising profile for MET-233i as a potential best-in-class amylin analog [2][4] Group 1: Clinical Trial Results - The Phase 1 trial was randomized, placebo-controlled, and double-blind, involving 80 participants with overweight or obesity without type 2 diabetes, evaluating doses from 0.15 mg to 2.4 mg [2][3] - Body weight loss was dose-dependent, with a mean of 8.4% at Day 36 after five weekly doses of 1.2 mg, and individual responses reached as high as 10.2% [4] - The pharmacokinetics showed a 19-day half-life, supporting once-monthly dosing and indicating the most durable profile among known amylin analogs [4] Group 2: Safety and Tolerability - Gastrointestinal adverse events were mild and primarily occurred in the first week, suggesting rapid tolerance development [4] - Anticipated starting doses of 0.15 mg and 0.3 mg showed tolerability results comparable to placebo [4] - No severe or serious adverse events were reported during the trial [4] Group 3: Future Developments - Metsera plans to advance MET-233i as a monotherapy and in combination with MET-097i, with topline data from an ultra-long acting GIP receptor agonist, MET-034i, expected in late 2025 [5][12] - The company is pursuing regulatory approval for the combination of MET-233i and MET-097i via the FDA biologic pathway [7] Group 4: Technology and Platform - MET-233i is developed using Metsera's HALO™ platform, which enhances peptide stability and allows for a longer half-life, potentially enabling monthly dosing [8] - The HALO™ platform is designed to improve tolerability and scalability of peptide therapies [8]