Zihipp Ltd.

Metsera, which is attempting to make long-acting obesity and metabolic disease medicines, has shared its first clinical data as a recently minted public company. The New York-based biotech said Monday morning that its amylin analog met expectations in a Phase 1 trial. The experimental injectable, called MET-233i, led to a weight loss of as much as 8.4% at day 36 following administration of five weekly 1.2 mg doses. Metsera said there were no severe or serious adverse events and that gastrointestinal side effects in the multiple ascending dose part of the study were mild and dose-dependent. The goal is to have “placebo-like tolerability,” Metsera medical chief Steve Marso said in an interview. The Phase 1 drug is not Metsera’s most advanced candidate. That title belongs to a long-acting GLP-1 receptor agonist known as MET-097i, which is in Phase 2b. But the results are an important moment for the biotech’s efforts to compete against other amylin drugs and to develop a long-acting therapy. After the success of GLP-1 drugs, biopharma companies have rushed into the amylin space to find the next breakout obesity drug, with Lilly, Novo Nordisk, Roche , AbbVie and others all vying for a spot. With clinical data on both MET-097i and MET-233i now in hand, Metsera has shown that its peptide engineering platform “really delivers,” CEO Whit Bernard said in an interview with Endpoints News . The company expects results from a 12-week monotherapy study of MET-233i in “late 2025.” The biotech is also running a 12-week trial testing MET-233i co-administered with MET-0971i. Those data are slated for “early 2026,” the company said. Metsera went public in a $275 million IPO in late January. It’s one of the few biotechs of the past few years to still be trading $MTSR above its IPO price. Prior to listing on the Nasdaq, Metsera conducted two major financings, acquired UK biotech Zihipp, did a deal for oral medicines with South Korea-based D&D Pharmatech and inked a critical manufacturing accord with Amneal.

Metsera, a well-funded biotech trying to angle toward the front of the obesity medicine pack, has proposed a $250 million IPO. That would be the size of net proceeds Metsera would gain from its Nasdaq debut if the company sells 17.18 million shares at the midpoint of a proposed $15 to $17 per share $MTSR range, according to an amended IPO document filed Monday. Another biotech, Maze Therapeutics, shared its IPO price range document earlier Monday, eyeing $113 million for its kidney disease drug. Metsera said it expects to use all $250 million from the planned IPO for an upcoming Phase 3 program of its most advanced candidate, an injectable GLP-1 receptor agonist called MET-097i. The money will bankroll late-stage topline results and milestone payments to Imperial College of Science, Technology and Medicine, according to Monday’s filing. Metsera devoted $20.2 million to the asset in the first nine months of 2024. MET-097i is being tested as a weekly option. The Phase 2b readout is slated for the middle of this year. Metsera also plans to begin a Phase 2b testing a monthly dosing regimen of the biologic. That study is expected to have results either at the end of this year or in early 2026, according to the S-1. Metsera got its hands on MET-097i by way of acquiring London startup Zihipp in 2023. Zihipp had the exclusive license to certain IP and products from Imperial College. Metsera could owe the college up to $26.1 million in development, regulatory and financial milestones, according to the S-1 filing. Metsera also must pay Imperial an annual license fee, plus low single-digit royalties if any of the products are approved. Beyond that lead candidate, Metsera has an amylin analog called MET-233i. Phase 1 data will arrive in the middle of this year. The biotech said it could eventually seek an NDA for the drug as a monotherapy, though Metsera is developing it “primarily” as a combo tool for MET-097i. Metsera leapt onto the scene last spring with a $290 million bet that it could quickly vie for a spot in the obesity drug world. It bought Zihipp and licensed a suite of assets from Korean biotech D&D Pharmatech. It then revealed early clinical data, signed a manufacturing partnership , promoted Whit Bernard to CEO and stapled together another nine-figure financing round .

Just seven months after unveiling with $290 million , obesity biotech Metsera is back with another $215 million. The New York-based company will use the Series B funds to support a recently started Phase 2 trial of a long-acting GLP-1 injectable and early-stage studies of a long-acting amylin analog injectable and an oral GLP-1 peptide, according to a new disclosure on Wednesday morning. The stakes are high and fast-paced for startups in obesity drug development. Shortly after Metsera broke cover in the spring, another $400 million biotech — Kailera — came out of stealth with drugs licensed from a partner in China and plans for Phase 3 studies. While Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound already dominate the GLP-1 market, some biotechs are looking to follow suit with improved versions of their own. Metsera is banking on making a once-monthly injectable as well as an oral option. Viking Therapeutics and AstraZeneca each presented more data about their oral GLP-1 candidates at the ObesityWeek conference in Texas last week. Amylin is also shaping up to be one of the prized next-generation bets in obesity. Biotechs think it could lead to less muscle loss and perhaps enhance the fat loss seen with GLP-1s. In Zealand Pharma’s eyes, it could also rid the need for GLP-1s for some patients. Metsera has solidified its strategy in recent months. It unveiled the first batch of data for its GLP-1 injectable , which showed about 7.5% weight loss from baseline at day 36. Then, last month, the company forged a manufacturing partnership with Amneal to shore up its supply capabilities for MET-097 in advance of a potential Phase 3 trial later next year. It also switched CEOs, replacing founder Clive Meanwell with Whit Bernard, a managing partner at Population Health Partners, Meanwell’s investment firm. Wellington Management and Venrock Healthcare led Metsera’s Series B. Fidelity, Janus Henderson, T. Rowe Price, Viking Global Investors and others also took part. The startup has now raised more than $500 million. Earlier this year, Metsera said it acquired London-based Zihipp and inked a licensing deal with Korea-based D&D Pharmatech. Meanwell said in September that Metsera’s shopping list of acquisition or licensing targets is at 200 companies and growing .