Apelin

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.

BioAge touts lead candidate azelaprag, an oral drug designed to pair well with GLP-1 drugs, boosting weight loss while preserving muscle mass.  After raising $170 million back in February, metabolic disease-focused BioAge Labs has filed to debut on the public market.The Eli Lilly-partnered biotech hopes to list on the Nasdaq under the symbol “BIOA,” according to documents filed with the Securities and Exchange Commission. The company has not publicly shared an expected monetary amount for the offering.The clinical-stage company touts lead candidate azelaprag, an orally delivered small molecule slated to enter phase 2 testing in combo with semaglutide—sold by Novo Nordisk under brand name Wegovy for weight loss—in the first half of next year. Semaglutide is also sold as Ozempic and Rybelsus by Novo for diabetes.Apelin receptor agonist azelaprag is designed to combine well with GLP-1 drugs, boosting weight loss while preserving muscle mass. The investigational drug was found to be well-tolerated among 265 individuals across eight phase 1 trials, according to BioAge."BioAge's IPO could serve as a bellwether for the sector, potentially catalyzing further investment and innovation," Kazi Helal, Ph.D., senior biotech analyst at PitchBook, told Fierce Biotech in an emailed statement. Other notable players in the space include Metsera, Hercules CM NewCo and SixPeaks Bio, according to Helal. Previously, BioAge garnered the support of Lilly to run a trial combining azelaprag with the Big Pharma’s GLP-1/GIP receptor agonist tirzepatide, which is marketed for diabetes as Mounjaro and Zepbound for weight loss. The partners are currently conducting a phase 2 trial of azelaprag and tirzepatide, with topline results expected in the third quarter of 2025.The biotech is also planning an insulin sensitivity proof-of-concept trial assessing azelaprag as a monotherapy in the first half of next year to support potential indication expansion. Furthermore, the company plans to ask the FDA for permission in the second half of 2025 to launch human testing for an NLRP3 inhibitor targeting metabolic diseases and neuroinflammation.BioAge’s anticipated move to the public market follows a slight uptick in planned biotech IPOs from Bicara Therapeutics and Zenas Biopharma. Zooming out, the recent IPO landscape is a “mixed picture,” with high-quality companies still debuting on the public markets, just in decreased numbers, according to PitchBook."As a phase 2 biotech entering the public market, BioAge will face increased scrutiny while navigating clinical trials and regulatory approvals," Helal said. "However, the current market enthusiasm for obesity treatments may provide a favorable environment for their debut."Editor's note: This story was updated at 4 pm on Sept. 4 to include analyst commentary.