Metsera, Inc. has made significant strides in its clinical development as it continues to advance its innovative treatments for obesity and metabolic disorders. The company’s pipeline includes several promising candidates, such as MET-097i, a long-acting GLP-1 receptor agonist, currently undergoing three Phase 2b trials. Initial data from VESPER-1 is anticipated by mid-2025. Additionally, MET-233i, an amylin analog, is in Phase 1 trials, both as a standalone treatment and in combination with MET-097i, with monotherapy results expected in the second quarter of 2025.
With a robust cash position of $588 million, Metsera is well-equipped to sustain its operations through 2027. The company has reported progress in its clinical trials and is committed to meeting its planned milestones for the year, including critical data releases for both injectable and oral therapies.
Pipeline Overview and Future Milestones
The Phase 2b trials for MET-097i are proceeding as scheduled, with plans to initiate Phase 3 trials by late 2025. This innovative drug is designed for subcutaneous injection and has demonstrated promising weight-loss results, showing up to a 14.2% reduction after extended dosing periods. Key findings are set to be presented at the upcoming American Diabetes Association conference, highlighting the unique benefits of MET-097i.
The ongoing VESPER program comprises three trials aimed at assessing the efficacy and safety of varying dosages of MET-097i. VESPER-1 focuses on weight loss in individuals with obesity without type 2 diabetes, with results expected in mid-2025. VESPER-2 targets patients with type 2 diabetes and obesity, while VESPER-3 evaluates multiple monthly doses following an initial weekly regimen. Both of these trials are projected to yield preliminary data by early 2026.
Updates on MET-233i and Oral Therapies
MET-233i, another promising candidate, is currently in Phase 1 trials. Data from the five-week monotherapy study is anticipated in Q2 2025, alongside further results from a combination study with MET-097i later in the year. This amylin analog aims to provide additional weight management options for patients.
In addition to its injectable therapies, Metsera is working on oral formulations, specifically MET-097o and MET-224o, both designed to treat obesity. The company has accelerated its development of MET-097o due to encouraging preclinical results and plans to commence Phase 1 trials in mid-2025, with initial data expected by late 2025.
Financial Performance in Q1 2025
As of March 31, 2025, Metsera reported cash and cash equivalents amounting to $588.3 million, a significant increase from the previous quarter. This financial stability is critical for supporting ongoing research and development activities, which incurred expenses of $57.2 million in the first quarter of 2025, up from $17.8 million in the same quarter last year.
General and administrative costs also rose, totaling $8.6 million, primarily due to increased personnel expenses. The company recorded a net loss of $76.6 million for the first quarter, reflecting its investment in various development initiatives.
Manufacturing and Organizational Developments
Metsera’s collaboration with Amneal is progressing, with new facilities being established in India dedicated to peptide synthesis and sterile manufacturing. This partnership will enhance Metsera’s production capabilities and optimize its supply chain.
Moreover, Metsera has appointed Jon P. Stonehouse to its Board of Directors and Matthew Lang as Chief Legal Officer. Both bring extensive experience in the biopharmaceutical industry, which will further strengthen the company’s leadership.
About Metsera
Founded in 2022 and headquartered in New York City, Metsera is a clinical-stage biopharmaceutical firm dedicated to developing next-generation therapies for obesity and metabolic diseases. The company is focused on a diverse portfolio of treatment options, including both oral and injectable therapies, aiming to establish itself as a leader in the rapidly evolving weight loss market.
Forward-Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties. These statements include expectations regarding clinical trial timelines, product development, and financial projections. Actual outcomes may differ significantly due to various factors, including regulatory challenges, market competition, and the company’s operational capabilities.
