HRS-9531

– Developing a broad, advanced, and differentiated portfolio of clinical-stage injectable and oral therapies for the treatment of obesity and related conditions – – Lead clinical program, KAI-9531, an injectable GLP-1/GIP receptor dual agonist, demonstrated compelling results in Phase 2 trials in obesity and type 2 diabetes – – Ron Renaud, Chief Executive Officer, will lead seasoned executive team with deep industry expertise; Industry veteran John F. Milligan named Chair of the Board – – Financing co-led by Atlas Venture, Bain Capital Life Sciences, and RTW Investments, with participation from Lyra Capital – BOSTON, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Kailera Therapeutics, Inc. (“Kailera” or “the Company”), today announced its launch as a clinical-stage biopharmaceutical company focused on advancing a broad pipeline of next-generation therapies for the treatment of obesity and related conditions. Kailera launches with a $400 million Series A financing co-led by Atlas Venture, Bain Capital Life Sciences, and RTW Investments, with participation from Lyra Capital. The Company is developing several clinical-stage injectable and oral therapies that have demonstrated potential as best-in-class treatments for chronic weight management. Kailera acquired exclusive rights for global development and commercialization of a portfolio of four metabolic disease assets outside of greater China from Jiangsu Hengrui Pharmaceuticals Co., Ltd (Hengrui), a leading global pharmaceutical company, in May 2024. Kailera’s most advanced program, KAI-9531 (in development as HRS9531 in China) is an injectable GLP-1/GIP (glucagon-like peptide-1, glucose-dependent insulinotropic polypeptide) receptor dual agonist that demonstrated compelling results in Phase 2 trials in obesity and type 2 diabetes in China. The Company is also advancing a diversified pipeline leveraging several mechanisms and routes of delivery, including KAI-7535, a clinical-stage oral small molecule GLP-1 receptor agonist, KAI-9531 formulated as a once-daily oral tablet, and KAI-4729, an injectable GLP-1/GIP/glucagon receptor tri-agonist. “In this period of rapid innovation in the metabolic space, I believe that Kailera is poised to make an impact beyond the current market leaders. We have an incredible opportunity to develop next-generation treatments for chronic weight management, helping people reclaim their health and live their lives to the fullest,” said Ron Renaud, Chief Executive Officer, Kailera Therapeutics. "With a clinically-advanced, differentiated pipeline, a talented and experienced team with a track record for building companies with lasting impact, and the support of a world-class investor syndicate, we are uniquely positioned to advance innovative therapies that have the potential to meaningfully impact both quality of life and overall health for many people.” Mr. Renaud brings more than 25 years of biotech leadership to Kailera, with deep expertise in executive leadership, finance, and operations. As CEO of Cerevel Therapeutics, he guided the company through significant milestones, culminating in its acquisition by AbbVie in 2024. Previously, Mr. Renaud spearheaded Translate Bio’s growth from an early-stage startup to a publicly traded company, establishing it as a leader in mRNA technology. As CEO of Idenix Pharmaceuticals, he streamlined operations and built a robust promising portfolio of potential treatments for hepatitis C. In conjunction with the launch, the Company also announced several key leadership appointments. Kailera’s seasoned management team brings deep industry experience and will be responsible for establishing operational infrastructure and driving critical milestones. The initial Kailera executive leadership team appointments include: Doug Bakan, Ph.D., Chief Technology Officer, formerly of Ventyx Biosciences, Arena Pharmaceuticals, and Medicis PharmaceuticalPaul Burgess, Chief Operating Officer and Chief Business Officer, formerly of Cerevel Therapeutics, Translate Bio, and CivitasPaula Cloghessy, Chief People Officer, formerly of Seres Therapeutics, Translate Bio, and Joule Unlimited TechnologiesScott Wasserman, M.D., Chief Medical Officer, formerly of Frazier Life Sciences, Latigo Biotherapeutics, and Amgen Additionally, John F. Milligan, Ph.D., has joined the Board of Directors as Chair. Dr. Milligan previously served as the President and Chief Executive Officer of Gilead Sciences, where he was instrumental in transforming the company from an early-stage private company into a global, multi-billion-dollar leader in biopharmaceuticals. Over the course of his three-decade tenure, he helped establish Gilead’s global presence and played a key role in the development and commercialization of over 25 innovative therapies, including the development of groundbreaking treatments for HIV and HCV. “I’m thrilled to join Kailera in their commitment to deliver next-generation therapies for obesity and related conditions,” said Dr. Milligan. “I look forward to working with the Kailera team to advance therapies with the potential to more comprehensively meet patients’ needs in short and long-term weight management and metabolic diseases, with a focus on improved efficacy and tolerability.” About Kailera TherapeuticsKailera Therapeutics (Kailera) is developing a broad, advanced, and differentiated portfolio of clinical-stage injectable and oral therapies for the treatment of obesity and related conditions. Kailera’s most advanced program, KAI-9531 (being developed in China as HRS9531), is an injectable GLP-1/GIP receptor dual agonist that demonstrated positive results in Phase 2 trials in obesity and type 2 diabetes in China. The Company is also advancing a diversified pipeline leveraging several mechanisms and routes of delivery, including oral administration. Kailera’s mission is to develop next-generation weight management therapies that give people the power to transform their lives and elevate their overall health. The Company is based in Waltham, MA and San Diego, CA. For more information, visit www.kailera.com and follow us on LinkedIn and X. Contact Information Maura GavaghanVice President, Corporate Communications and Investor Relationsmaura.gavaghan@kailera.com

There’s major money behind efforts to speed the next significant obesity company to the market. First, it was Metsera, which launched in April with $290 million and a busy pipeline. Now it’s Kailera Therapeutics, with $400 million from Bain Capital Life Sciences, Atlas Venture, RTW and Lyra Capital. Kailera isn’t a startup in the eyes of CEO Ron Renaud, who led a hepatitis C biotech , an mRNA startup and a neuroscience drug developer to multibillion-dollar sales to pharmaceutical companies. “People are going to say, ‘Oh it’s another startup,’” said Renaud, who took the CEO role last month. “This isn’t a startup. It’s going to be a new company, but we’ve got an advanced, a truly advanced, clinically-validated portfolio of next-generation therapies for the treatment of obesity and obesity-related disorders.” Kailera has snagged the exclusive rights for a suite of four experimental drugs for obesity and related conditions from Jiangsu Hengrui Pharmaceuticals, and the Boston-based drug developer will use Jiangsu Hengrui’s work in China to move straight into a global Phase 3 study in obesity. Endpoints News first reported on the deal between the two companies in May, when Kailera was known as Hercules CM. Its lead drug is an injectable GLP-1/GIP dual agonist, formerly known as HRS9531, which has already been in Phase 2 in obesity and type 2 diabetes in China. Kailera renamed the drug KAI-9531. Kailera will work “as quickly” as it can to get the global Phase 3 up and running, Renaud said, but declined to disclose specific timelines. The company needs to speak with international regulators about the trial design, he said, including whether the trial will need to be a head-to-head against Novo Nordisk’s semaglutide, Eli Lilly’s tirzepatide, or both. Many of the large pharmaceutical companies and a cohort of smaller biotechs are looking to get into the obesity market through GLP-1-based regimens or with next-generation drugs using different mechanisms. With Novo and Lilly’s GLP-1s already deeply entrenched, it will likely be a steep challenge for newer entrants like Kailera and Metsera, which released its first Phase 1 data on a long-acting GLP-1 injectable last week. Metsera plans to begin a Phase 2b by the end of this year and could get into Phase 3 by the end of 2025, former CEO Clive Meanwell has told Endpoints. Both Metsera and Kailera believe there’s still a chance for newer entrants. “This is a massive market that is still not completely addressed,” Renaud said. Renaud is familiar with the high stakes. He led Cerevel as it worked on a similar schizophrenia drug as Karuna Therapeutics. Bristol Myers Squibb bought Karuna for $14 billion a few weeks after AbbVie said it would acquire Cerevel. The FDA approved Bristol Myers’ drug last week. Beyond the GLP-1 injectable, Kailera has an oral GLP-1 receptor agonist, a GLP-1/GIP/glucagon tri-agonist (or triple-G) and an oral form of its lead injectable from Hengrui. Hengrui is slated to begin a healthy volunteer study of the triple-G in early 2025, and Kailera anticipates starting its own trial of the drug (KAI-4729) on a “similar time frame,” Renaud said. Kailera is working with external contract drug manufacturers and “all options are on the table” as it heads toward Phase 3 and potentially commercialization. That could include building or buying manufacturing sites, he said. Novo and Lilly have spent billions to buy and build sites as their Wegovy and Zepbound franchises have outstripped supply. While the company has $400 million in commitments, Renaud acknowledged the obesity drug development landscape is “not an inexpensive endeavor.” Kailera paid $110 million to Hengrui. Whether an IPO is the next financing step has not been determined yet, he said. The 25-employee company will quickly double or triple in staff by the second quarter of next year, the CEO said. Renaud’s C-suite already includes chief medical officer Scott Wasserman , who was previously CEO of pain drug developer Latigo. It also includes technical chief Doug Bakan, operating and business chief Paul Burgess (also from Cerevel and Translate Bio), and chief people officer Paula Cloghessy. Ex-Gilead CEO John Milligan is the chair.