Metsera Reports First Quarter 2025 Financial Results and Continued Portfolio Progress

MET-097i, a fully biased, monthly, ultra-long acting GLP-1 receptor agonist, is in three ongoing VESPER Phase 2b trials, with data from VESPER-1 expected in mid-2025

MET-233i, a monthly, ultra-long acting amylin analog, is in Phase 1 trials as a monotherapy and co-administered with MET-097i, with five-week monotherapy data expected in Q2 2025

MET-097(o) (,) an oral formulation of MET-097i, has been accelerated and alternate oral candidate MET-224(o) is on track, with four-week data for selected lead expected in late 2025

$588 million cash and cash equivalents support runway into 2027

NEW YORK, May 12, 2025 (GLOBE NEWSWIRE) -- Metsera, Inc. (Nasdaq: MTSR), a clinical-stage biopharmaceutical company accelerating the next generation of medicines for obesity and metabolic diseases, today reported first quarter 2025 financial results and continued portfolio progress.

"The first quarter of 2025 was a period of focused execution and acceleration at Metsera," said Whit Bernard, Chief Executive Officer of Metsera. "We remain on track to deliver on all of our committed clinical milestones for 2025, including five-week data for our ultra-long acting amylin analog MET-233i in Q2, 28-week data for our ultra-long acting GLP-1 RA MET-097i by mid-year, and multiple additional clinical readouts of our injectable and oral programs by year-end."

Chris Visioli, Chief Financial Officer, added: "In the first quarter of 2025, we successfully completed a $316 million IPO and continued to build on our track record of efficient and disciplined capital deployment. We believe we have sufficient cash on hand to fund operations into 2027."

Pipeline Highlights and Upcoming Milestones

MET-097i: Phase 2b program on track, with Phase 3 initiation planned in late 2025

   -- MET-097i is a fully biased, monthly, ultra-long acting, subcutaneously 
      injectable GLP-1 receptor agonist $(RA)$. In early 2025, we disclosed 
      competitive body weight loss and differentiated tolerability data for 
      MET-097i after twelve weekly doses, with favorable tolerability and 
      continued weight loss up to 14.2% after a thirteenth, potential monthly 
      dose. We plan to release additional results from this trial at the 
      American Diabetes Association's $(ADA.AU)$ 85th Scientific Sessions, in 
      addition to several other presentations focused on MET-097i. 
 
   -- The VESPER program includes three ongoing Phase 2b trials designed to 
      further evaluate the differentiated profile of MET-097i, and enable rapid 
      transition into Phase 3 clinical trials: 
 
          -- VESPER-1 is designed to assess weight loss of different weekly 
             doses of MET-097i over 28 weeks in participants with obesity or 
             overweight without type 2 diabetes. The trial was fully enrolled 
             as of end-2024, and preliminary results are expected in mid-2025. 
 
          -- VESPER-2 is designed to assess weight loss and tolerability of 
             different weekly doses of MET-097i over 28 weeks in participants 
             with type 2 diabetes and obesity or overweight. Preliminary 
             results are expected in early 2026. 
 
          -- VESPER-3 is designed to assess weight loss and tolerability of 
             multiple monthly doses of MET-097i after 12 initial weekly doses 
             in individuals with obesity or overweight without type 2 diabetes. 
             Preliminary results are expected by year-end 2025 or in early 
             2026. 
 
   -- Pending VESPER-1 results, we remain on track to initiate a Phase 3 
      program of MET-097i in late 2025. 

MET-233i: Five-week monotherapy data readout expected in Q2 2025, with additional monotherapy and co-administration readouts planned in late 2025

   -- MET-233i is a monthly, ultra-long acting, subcutaneously injectable 
      amylin analog in ongoing Phase 1 trials as a monotherapy and 
      co-administered with MET-097i. 
 
   -- Preliminary five-week weight loss, tolerability, and pharmacokinetic data 
      from the monotherapy Phase 1 trial are expected in Q2 2025, and 12-week 
      data from this trial are expected in late 2025. 
 
   -- Preliminary five-week weight loss, tolerability, and pharmacokinetic data 
      from the Phase 1 co-administration trial are expected in late 2025. 

Oral peptide platform: MET-097(o) oral program accelerated and alternate oral candidate MET-224(o) on track; four-week data for selected lead expected in late 2025

   -- MET-097o and MET-224o are oral, fully biased, ultra-long acting GLP-1 
      receptor agonists in development for the treatment of obesity and 
      overweight. 
 
   -- Our ongoing Phase 1 formulation optimization study using prototype oral 
      GLP-1 receptor agonist MET-002o is on track. 
 
   -- Promising preclinical oral exposure data for MET-097o, combined with the 
      compelling clinical profile of injectable MET-097i, have led us to 
      accelerate MET-097o as a potential lead oral candidate. 
 
   -- We plan to initiate Phase 1 trials of MET-097o and MET-224o in mid-2025, 
      and to select and advance the best-performing oral candidate based on the 
      Phase 1 clinical data. Preliminary four-week weight loss, tolerability, 
      and pharmacokinetic data for the selected lead candidate are expected in 
      late 2025. 

First Quarter 2025 Financial Results

Cash Position: Cash and cash equivalents were $588.3 million as of March 31, 2025, after taking into account proceeds from the IPO, compared to $352.4 million as of December 31, 2024. Based on current operating plans, Metsera estimates its existing cash and cash equivalents will be sufficient to fund projected operating expenses, working capital and capital expenditure needs into 2027.

R&D Expenses: Research and development (R&D) expenses were $57.2 million for the quarter ended March 31, 2025, compared to $17.8 million for the quarter ended March 31, 2024. R&D expenses increased primarily due to product candidate development costs related to preclinical, clinical and contract manufacturing.

G&A Expenses: General and administrative (G&A) expenses were $8.6 million for the quarter ended March 31, 2025, compared to $4.1 million for the quarter ended March 31, 2024. G&A expenses increased primarily due to personnel-related expenses, including stock-based compensation.

Net Loss: Net loss was $76.6 million for the quarter ended March 31, 2025, compared to $19.9 million for the quarter ended March 31, 2024. For the three months ended March 31, 2025, net loss consisted of R&D and G&A expenses totaling $65.8 million and a change in fair value of contingent consideration of $14.0 million. Net cash used in operating activities was $54.3 million.

Manufacturing Updates

Amneal strategic collaboration advancing as part of Metsera's broader supply network: Construction of new Amneal facilities in India with Metsera-dedicated lines for peptide synthesis and sterile fill-finish manufacturing remains on track. Amneal also maintains extensive US manufacturing capabilities, with additional investments planned to expand this footprint. We plan to work actively with Amneal to optimize our commercial stage manufacturing footprint across Amneal's US and global network.

Organizational Updates

Jon P. Stonehouse appointed Director: The Board of Directors of Metsera appointed Jon P. Stonehouse as a Class III director and member of the Audit Committee. Mr. Stonehouse is the Chief Executive Officer and Director of BioCryst Pharmaceuticals, Inc., a commercial stage biotechnology company, which he joined in January 2007. He has an extensive background in executive leadership roles in the biopharmaceutical industry.

Matthew Lang appointed Chief Legal Officer: Metsera appointed Matthew Lang as Chief Legal Officer and Secretary. Mr. Lang most recently served as the Chief Business Officer and Chief Legal Officer and Corporate Secretary of Lyell Immunopharma, Inc. from July 2023 to April 2025. Before joining Lyell, Mr. Lang held several executive officer positions at Myovant Sciences, Inc. between 2017 and 2023, most recently as Chief Administrative and Legal Officer. Earlier in his career Mr. Lang held roles of increasing seniority at Gilead Sciences, and was an attorney at Dechert, LLP. He received his B.A. in Classical Studies from Queen's University at Kingston, Canada and his J.D. from the University of Pennsylvania Law School.

About Metsera

Metsera is a clinical-stage biopharmaceutical company accelerating the next generation of medicines for obesity and metabolic diseases. Metsera is advancing a broad portfolio of oral and injectable incretin, non-incretin and combination therapies with potential best-in-class profiles to address multiple therapeutic targets and meet the future needs of a rapidly evolving weight loss treatment landscape. Metsera was founded in 2022 and is based in New York City. For more information, please visit us at www.metsera.com and follow us on LinkedIn and X.

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Forward-Looking Statements

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May 12, 2025 07:00 ET (11:00 GMT)