Financing led by Wellington Management and Venrock, with participation from Fidelity Management & Research Company, T. Rowe Price, Janus Henderson and others to fund highly competitive, clinical-stage portfolio

Phase 2 trial of ultra-long acting, fully-biased injectable GLP-1 RA underway

Ultra-long acting amylin analog clinical trials initiated

Oral GLP-1 RA peptide program clinical trials initiated

November 13, 2024 07:00 AM Eastern Standard Time

NEW YORK–(BUSINESS WIRE)–Metsera, Inc., a clinical-stage biopharmaceutical company accelerating the next generation of medicines for obesity and metabolic diseases, today announced the close of a $215 million Series B financing to further advance its portfolio of highly differentiated, clinical-stage, Nutrient-Stimulated Hormone (NuSH) analog peptides.

“We are delighted to welcome our new Series B investors and thank existing investors for their continued support”Post this

Series B financing backed by leading mutual funds and healthcare investors

Wellington Management and Venrock Healthcare Capital Partners led the financing, with participation from new investors including Fidelity Management & Research Company, Janus Henderson Investors, funds and accounts advised by T. Rowe Price Associates, Inc. and by T. Rowe Price Investment Management, Inc., Viking Global Investors, Deep Track Capital, and RA Capital Management. Existing Metsera investors, including ARCH Venture Partners, Alpha Wave Ventures, GV, SoftBank Vision Fund 2, Newpath Partners, SymBiosis, and other undisclosed investors, also participated. Metsera has raised over $500 million to date.

Highly competitive, clinical-stage portfolio accelerating

Phase 2 trials of ultra-long acting, fully-biased injectable GLP-1 RA underway
Metsera recently reported significant and durable weight loss from the Phase 1/2 trial of MET-097i, a novel, fully-biased, potential once-monthly injectable GLP-1 RA engineered with Metsera’s HALO™ lipidation platform. MET-097i showed a 7.5% reduction in body weight from baseline at day 36 and a 380-hour half-life. Following this positive clinical data, Metsera initiated a randomized, 16-week Phase 2 trial of MET-097i in participants with obesity and overweight, with preliminary data expected in the first half of 2025. A 13-week randomized extension of the previously announced Phase 1/2 trial is also underway. If these trials are successful, Metsera expects to initiate Phase 3 trials of MET-097i shortly thereafter.

Ultra-long acting amylin analog clinical trial initiated
Metsera has initiated a single and multiple ascending dose clinical trial of MET-233i, an ultra-long acting injectable amylin analog designed for potential once-monthly dosing, in participants with obesity and overweight. MET-233i is the first of multiple next-generation NuSH analog peptides designed for combination and co-formulation with MET-097i, with matched solubility parameters and half-life. MET-233i and Metsera’s other next-generation NuSH analog peptides are also engineered with Metsera’s HALO™ lipidation platform.

Oral GLP-1 RA peptide program clinical trial initiated
Metsera has initiated a clinical trial of MET-002, an oral GLP-1 RA peptide. Metsera has developed its proprietary MOMENTUM™ platform to optimize oral delivery of NuSH analog peptides and is advancing multiple GLP-1 RA peptides with potential best-in-class bioavailability, and multiple potential first-in-class oral follow-on candidates targeting other NuSH pathways, to be developed alone and/or in combination with other NuSH analog peptides.

NuSH pipeline acceleration continues
Metsera continues to advance multiple candidates from its proprietary peptide library, built upon approximately 20,000 NuSH analog peptides and developed through twenty years of empirical biological research and advanced peptide engineering. These candidates include MET-034i, an ultra-long acting, HALO™ lipidated GIP RA, and candidates targeting other complementary NuSH pathways, including glucagon and PYY, as well as unimolecular multi-NuSH combinations. Metsera is also studying combinations of these candidates.

“We are excited to join a great investor syndicate to support Metsera’s differentiated portfolio of products for obesity,” said Nilesh Kumar, Head of Biotech Private Investments at Wellington Management. Nimish Shah, Partner at Venrock, added, “With an impressive management team, industry-leading peptide engineering capabilities, scaled manufacturing, and expert clinical execution, Metsera is positioned for significant value creation.”

“We are delighted to welcome our new Series B investors and thank existing investors for their continued support,” said Whit Bernard, Chief Executive Officer of Metsera. “Building on over twenty years of research, in the past two years Metsera has constructed a leading portfolio, initiated a large-scale manufacturing partnership, and assembled a high-performing, agile team. We now have three medicines in the clinic with more to come, based on a best-in-class half-life extension technology and a potential best-in-class oral peptide delivery platform. We look forward to continued acceleration of our pipeline.”

About MET-097i

MET-097i, Metsera’s most advanced product candidate, is a novel, fully-biased, potential once-monthly subcutaneously injectable GLP-1 RA. In September 2024, Metsera reported positive results from the Phase 1/2 trial of MET-097i. In the study, MET-097i demonstrated significant and durable weight loss, including 7.5% reduction in body weight from baseline at day 36. MET-097i, incorporating Metsera’s HALO™ platform technology, showed a 380-hour half-life, supporting the potential for once-monthly dosing and dosing regimens without titration. Weight loss continued for at least four weeks after the last dose was administered. MET-097i is being advanced into late-stage clinical trials as a monotherapy, as well as initial clinical trials in combination with MET-233i and other NuSH analog peptide injectables.

About Metsera’s HALO™ peptide lipidation platform

HALO™ is a novel peptide lipidation platform technology developed over 20 years of research and wholly owned by Metsera. The HALO™ approach enables peptides to bind simultaneously to albumin and to a drug target, resulting in a half-life approaching that of albumin and exceeding that of other NuSH peptides by two-to-threefold. This ultra-long half-life enables four key advantages: titration-free dosing, monthly dosing, improved tolerability, and improved scalability.

About Metsera’s MOMENTUM™ oral peptide delivery platform

MOMENTUM™ is a platform for scalable delivery of oral peptides. The platform integrates multiple proprietary technologies to deliver therapeutic effects at dose levels substantially lower than competitive NuSH oral peptides, unlocking the potential for injectable-like efficacy and tolerability with similar manufacturing scale advantages to non-peptide, small molecule approaches.

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. Founded in 2022 by Population Health Partners and ARCH Venture Partners, Metsera has raised over $500 million in financing from leading healthcare investors and is based in New York City. For more information, please visit us at www.metsera.com and follow us on LinkedIn and X.

Contacts

Media:
Dan Budwick
1AB
dan@1abmedia.com

Investors:
Matt Clawson
1AB
matt@1abmedia.com

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