Metsera, Inc.

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 .

Aardvark Therapeutics filed for an IPO Thursday night, making it the sixth biotech in line this year for a potential listing on the Nasdaq. The San Diego biotech is trying to break into the obesity field from a different angle, by targeting hunger signals rather than suppressing appetite like megablockbuster GLP-1s. “Most folks will conceptualize appetite and hunger as, ‘Aren’t they just different extremes along the same continuum?’” Aardvark CEO Tien Lee told Endpoints News in May 2024, after the company raised an $85 million Series C . “But they’re actually two different neurologic drives.” Its lead drug, ARD-101, is being tested in Prader-Willi syndrome-associated hyperphagia, a rare genetic disease that can cause unrelenting feelings of hunger. The experimental drug goes after a bitter taste receptor agonist called TAS2R, and Aardvark expects to have Phase 3 data in early 2026, according to the securities filing. ARD-101 will also enter Phase 2 in hypothalamic obesity-associated hyperphagia in the second half of this year, according to the filing. Around that same time, Aardvark will also start a Phase 2 trial of another oral TAS2R agonist, ARD-201, in combination with a DPP-4 inhibitor in people with obesity. Aardvark is far from the only young company seeking a piece of an obesity market that’s currently dominated by Eli Lilly and Novo Nordisk. And competing won’t be cheap. Investors have funneled $400 million into two new obesity companies in recent months, and several others are already publicly listed. Companies in the space have found themselves investing early in manufacturing and trial data to separate themselves from the pack. Aardvark would trade under the ticker $AARD . It joins obesity biotech Metsera , kidney disease drug developer Maze, cystic fibrosis company Sionna and immunology startup Odyssey with IPO plans. And Hong Kong Stock Exchange-listed Ascentage Pharma will get about $126 million from its dual listing in the US on Friday. Lee founded the company in 2017. He and his spouse, Jane Wu Lee, are the largest shareholders in Aardvark, holding a combined 19.1%, according to the filing. Decheng Capital is the second largest shareholder at 17.2%. Vickers Venture Fund is 0.1% behind. In the interview last May, the CEO told Endpoints an “IPO is on the table if the market conditions are reasonable, but we’re not necessarily having that as our only plan.” At the time, the biotech was “having meaningful conversations with more than one large pharma company that are exploring possibilities for licensing or partnership.” Aardvark didn’t disclose how much it seeks to raise in the IPO. The 18-employee company spent $9.3 million on R&D in the first nine months of 2024. It had $82.3 million in cash, equivalents and short-term investments at the end of September. It has also tested another asset, ARD-501, for autism spectrum disorder. Its pipeline also includes an oral candidate for overactive bladder, a topical for inflammatory skin disorders and an abuse deterrent.

Dive Brief:Ascentage Pharma, a cancer drug developer based in Suzhou, China, on Thursday raised just over $126 million in the first U.S. initial public offering by a biotechnology company this year.The company, which is already publicly traded in Hong Kong, sold 7,325,000 American depositary shares at $17.25 apiece, a lower price than it had projected earlier this week. Shares will begin trading on the Nasdaq Stock Exchange Friday under the ticker symbol AAPG.Ascentage will use the proceeds to develop treatments for cancer, among them a leukemia drug called olverembatinib thats approved in China. Its IPO comes amid increased dealmaking involving drugs from China, a trend industry watchers expect to continue this year. Ascentage is one such beneficiary, having licensed olverembatinib to Takeda last year.Dive Insight:Ascentages Wall Street debut is a test of U.S. investors interest in the progress Chinas biotech sector has made.Efforts by the Chinese government to boost the countrys capabilities have produced a burgeoning ecosystem of drug companies, many of which are trying to improve on medicines either on the market or in development. That, combined with tight funding in biotech, has led to a flurry of licensing deals.Though relatively few China-based biotechs have reached public markets in the U.S., some, like oncology-focused drug developers Legend Biotech and BeiGene, have prospered.Ascentage is developing small molecule drugs that block or degrade protein targets implicated in cancer. Its most advanced prospect is olverembatinib, which is cleared in China for certain people with chronic myeloid leukemia. Its in multi-country Phase 3 trials in CML, as well as for two other forms of cancer.Though similar drugs, such as Novartis Gleevec and Scemblix, are available, there is room for improvement, as CML can be stubbornly resistant to approved therapies, Ascentage said in its IPO prospectus.A second Ascentage drug, lisaftoclax, is in late-stage testing for blood cancers including chronic lymphocytic leukemia and acute myeloid leukemia and is under regulatory review in China. Ascentage claims it has the potential to become a backbone molecule for combination regimens.Three additional drugs are in clinical testing for a variety of other tumors.Ascentage was formed in Hong Kong in 2009, and has headquarters in Suzhou as well as in Rockville, Maryland. The company generated 877 million yuan in revenue, or about $125 million, over the first nine months of 2024, according to its IPO filing. Most came from the $100 million Takeda paid to license olverembatinib.The IPO could be the first of several to price in the coming weeks. Five companies Maze Therapeutics, Metsera, Aardvark Therapeutics, Sionna Therapeutics and Odyssey Therapeutics outlined IPO plans in January.Overall, however, biotech IPOs have remained stagnant since 2022, with only around two dozen companies going public in each of the past three years, according to BioPharma Dive data. Most trade below their debut price. '