NLRP3

A California biotech that began as an anti-aging company, then licensed an Amgen heart failure drug for $1 million upfront and repurposed it as a weight loss therapy, has lined up a $198 million IPO. BioAge Labs will begin trading as $BIOA on Thursday after pricing its Nasdaq debut at $18 per share, the midpoint of the $17-to-$19 range it proposed last week. Earlier Wednesday, the company upsized its IPO plans from 7.5 million shares to 10.5 million shares . The final pricing was upsized again to 11 million shares. The nine-year-old startup confidentially filed for its IPO in late May — just a few months after a $170 million Series D round. The market for new companies has been heating up following a long-awaited Federal Reserve interest rate cut, with upsized IPOs from Bicara, Zenas and MBX earlier this month. And Upstream Bio and CAMP4 Therapeutics have IPOs pending as well. BioAge wasn’t in desperate need of money — with cash and equivalents of $159 million at the end of June — but being a public company as it advances into critical Phase 2 trials could give it easier access to capital. BioAge’s experimental medicine, an oral apelin receptor agonist named azelaprag from Amgen, is one of many next-generation obesity medications being developed by biotechs looking to follow the success of market leaders Eli Lilly and Novo Nordisk. It’s pairing azelaprag with those first-generation blockbuster medications, and it recently entered Phase 2 in combination with Lilly’s tirzepatide, with plans for another Phase 2 that will pair azelaprag with Novo’s semaglutide. The startup also has an oral NLRP3 inhibitor in preclinical testing for metabolic disease and neuroinflammation. Sanofi invested in a Phase 2 NLRP3 biotech this week, and other drugmakers are exploring the target, including Novo and NodThera . The 60-employee company’s largest shareholder is its co-founder and CEO Kristen Fortney, who owned 9.82% prior to the IPO, according to an S-1 filing . Slightly behind her is a16z Bio + Health at 9.36%. Khosla Ventures, Sofinnova Investments, Longitude Venture Partners, RA Capital, Cormorant, Kaiser Permanente and Horsley Bridge are BioAge’s other main shareholders.

RICHMOND, Calif., Sept. 25, 2024 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. (“BioAge”) (Nasdaq: BIOA), a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases, such as obesity, by targeting the biology of aging, today announced the pricing of its upsized initial public offering of 11,000,000 shares of its common stock at a public offering price of $18.00 per share. All of the shares are being offered by BioAge. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be $198.0 million. The shares are expected to begin trading on the Nasdaq Global Select Market on September 26, 2024 under the ticker symbol “BIOA.” The offering is expected to close on September 27, 2024, subject to the satisfaction of customary closing conditions. In addition, BioAge has granted the underwriters a 30-day option to purchase up to an additional 1,650,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions. Goldman Sachs & Co. LLC, Morgan Stanley, Jefferies, and Citigroup are acting as joint book-running managers for the offering. Registration statements relating to these securities have been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on September 25, 2024. A copy of the registration statements can be accessed through the SEC's website at www.sec.gov. The offering is being made only by means of a prospectus forming part of the registration statements relating to these securities. A copy of the final prospectus, when available, may be obtained from Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, or by email at Prospectus-ny@ny.email.gs.com; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by email at prospectus@morganstanley.com; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at Prospectus_Department@Jefferies.com; Citigroup, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at 800-831-9146. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About BioAge Labs BioAge is a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases, such as obesity, by targeting the biology of human aging. BioAge’s lead product candidate, azelaprag, is an orally available small molecule agonist of APJ that has been well-tolerated in 265 individuals across eight Phase 1 clinical trials, including a Phase 1b clinical trial where decreased muscle atrophy, preservation of muscle quality and improved metabolism were observed in subjects treated with azelaprag over a 10-day period. In mid-2024, BioAge initiated a Phase 2 trial of azelaprag in combination with tirzepatide for the treatment of obesity in older adults. Azelaprag has potential as an oral regimen to improve weight loss and restore both body composition and muscle function in patients on obesity therapy with incretin drugs. BioAge is also developing orally available small molecule brain penetrant NLRP3 inhibitors for the treatment of diseases driven by neuroinflammation. BioAge’s preclinical programs, based on novel insights from the BioAge’s discovery platform built on human longevity data, also have the potential to address key pathways in metabolic aging. Forward-looking statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements." These statements include, but are not limited to, statements relating to the anticipated use of net proceeds from the offering, BioAge's expectations regarding the commencement of trading of its shares on the Nasdaq Global Select Market, the completion and timing of the closing of the offering and the anticipated gross proceeds from the offering. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to market conditions, the satisfaction of customary closing conditions related to the offering, the completion of the offering on the anticipated terms or at all, and other factors discussed in the "Risk Factors" section of the final prospectus that forms a part of the effective registration statement filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release are based on the current expectations of BioAge's management team and speak only as of the date hereof, and BioAge specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. ContactsPR: Chris Patil, media@bioagelabs.com IR: Elena Liapounova, ir@bioagelabs.com Partnering: partnering@bioagelabs.com

Interest in metabolic medicines is riding high, led by the popular class of weight management drugs known as GLP-1 agonists. BioAge Labs aims to help those medications work better with a lead drug candidate envisioned as a part of new GLP-1 combination therapies. With a key clinical trial already underway, BioAge has joined the public markets, raising more than $200 million to continue development of its lead program and others in its pipeline. Strong investor demand enabled BioAge to boost the size of its stock offering. After setting preliminary terms of offering 7.5 million shares in the range of $17 and $19 apiece, which would have raised $135 million at the pricing midpoint, the Richmond, California-based company on Wednesday revised those terms upward to 10.5 million shares. When BioAge finally priced its IPO late Wednesday, it ended up offering 11 million shares at the $18 pricing midpoint, raising $198 million. According to BioAge’s amended IPO filing, Sofinnova Venture Partners, an earlier investor in the company, agreed to purchase about $10.6 million worth of shares in a concurrent private placement. That additional investment brings BioAge’s cash haul to $208.6 million. BioAge shares now trade on the Nasdaq under the stock symbol “BIOA.” presented by Health IT Accelerating Claim Processing: Strategies to Shorten the Life of a Claim These strategies and practices can significantly shorten the life cycle of claims, leading to quicker resolutions and improved financial outcomes. By Greenway Health BioAge’s lead drug candidate, azelaprag, targets the apelin receptor, which plays a role in several physiological functions, including cardiovascular function and energy metabolism. By activating this receptor, BioAge aims to mimic many of the biological benefits of exercise at the protein level, according to the IPO filing. The oral small molecule was originally developed by Amgen, which had advanced it as far as Phase 1 testing as a potential treatment for heart failure. While trial results showed the drug was safe, Amgen decided against further development in cardiovascular applications. In 2021, BioAge licensed global rights to azelaprag for all indications. The biotech, which was founded to develop drugs that treat the biology of aging, initially tested the small molecule as a way to preserve muscle mass in elderly patients. In BioAge’s own Phase 1 test in healthy volunteers age 65 and older, results showed azelaprag prevented muscle atrophy. Though BioAge had planned a Phase 2 test in elderly intensive care unit patients, the company has also maintained this molecule has a wide range of potential applications. Preclinical research in mice found the pairing of azelaprag with Eli Lilly weight management drug Zepbound led to greater weight loss than Zepbound alone. Furthermore, BioAge reported the drug combination led to improvement in body composition and muscle function. That’s important because one ongoing issue with GLP-1 agonists (also known as incretin mimetics) is that the weight patients lose includes muscle as well as fat. “We believe combination of azelaprag and an incretin is a pharmacological parallel to diet and exercise; one mechanism relies largely on reducing energy intake, the other on increasing energy expenditure,” BioAge said in the filing. presented by Sponsored Post The Promise of Value-Based Care and MedTech Innovation Monica Vajani, Executive Director for mHUB’s MedTech Accelerator, discusses how mHUB is helping innovators transition healthcare towards value-based care. By Monica Vajani - mHUB Last fall, BioAge announced plans for a Phase 2 study testing oral azelaprag in combination with Lilly’s injectable obesity medication, Zepbound. The pharmaceutical giant is supplying its drug for the study. Chorus, an independent clinical research organization within Lilly, is assisting the clinical trial. The ongoing study is testing once-daily and twice-daily doses of azelaprag in combination with Zepbound compared to the Lilly drug alone. The main goal is measuring the percentage of weight lost at 24 weeks. Exploratory endpoints include assessing body composition, blood sugar control, and patient-reported outcomes such as quality of life. Preliminary results are expected in the third quarter of 2025. BioAge believes azelaprag will work across the class of GLP-1 drugs, not just Lilly’s Zepbound. The company is planning a second Phase 2 study evaluating its lead drug in combination with Novo Nordisk’s GLP-1 agonist, Wegovy. The main goal is measuring weight loss at 52 weeks; exploratory goals are similar to the Zepbound study. BioAge said it expects to begin this clinical trial in the first half of 2025. Preliminary results could come in the second half of 2026. In the filing, BioAge said it hopes the results from its Phase 2 tests will support the company’s ultimate goal of developing an all-oral combination product for obesity. The company did not specify whether the plan is to develop its own oral GLP-1 drug to pair with azelaprag or to pair the apelin receptor agonist with one of the oral GLP-1 drugs currently in development by other companies. BioAge was co-founded in 2015 by CEO Kristen Fortney, whose background is in aging science. The heart of the company is a technology platform that analyzes human datasets to reveal insights about the molecular changes that drive aging. With those insights, BioAge can then identify promising drug targets. This technology discovered apelin signaling as way to potentially preserve metabolic health. “We’re really data driven, human data driven,” Fortney said in a 2022 interview. “Aging is really complicated and the science is really new.” The BioAge technology has yielded an internally discovered small molecule that targets and blocks NLRP3, a protein complex associated with neuroinflammation. In the IPO filing, the company said NLRP3-driven neuroinflammation has been linked to both obesity and neurodegenerative disease. BioAge’s NLRP3 inhibitor, code-named BGE-100, is on track for an investigational new drug application in the second half of 2025. Fortney is BioAge’s largest shareholder with a 6.7% post-IPO stake, according to the filing. Andreesen Horowitz and Khosla Ventures own 6.2% and 5.3% respectively. Prior to the IPO, BioAge said it had raised $320.7 million. The most recent financing was a $170 million Series D round this past winter. As of the end of June, BioAge reported a cash position of $159.1 million. Following the IPO, BioAge plans to use about $140 for the Phase 2 tests of azelaprag. IPO proceeds will also support manufacturing of the drug for planned Phase 3 studies. BioAge has set aside $15 million for a test of azelaprag as a monotherapy, which could support expanding the drug to additional indications. Another $20 million is earmarked for an investigational new drug application submission and the start of Phase 1 testing of its NLRP3 inhibitor for neuroinflammation. BioAge estimates its capital will support the company into 2029.