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We are an advanced clinical-stage biotechnology company focused on elevating the next era of obesity care by advancing a diversified pipeline to provide options for people living with obesity no matter where they are in their treatment journey. Obesity is a chronic, progressive and debilitating disease that impacts over 1 billion people globally and requires long-term comprehensive treatment. Since obesity is the driving factor for more than 200 comorbidities and represents a significant contributor to increased morbidity and mortality, our vision is to deliver category-leading obesity management medications that give people the power to restore their health and transform their lives. With our obesity-first focus, we have built a diversified pipeline of product candidates specifically designed to address critical needs in the current therapeutic landscape with a lead product candidate that we believe offers the potential for the greatest weight loss. We are rapidly progressing four clinical-stage product candidates, leveraging multiple glucagon-like peptide-1, or GLP-1, based mechanisms of action and routes of administration. Our lead product candidate, ribupatide (also known as KAI-9531), is currently being evaluated in global Phase 3 trials as a once-weekly injectable GLP-1/glucose-dependent insulinotropic polypeptide, or GIP, receptor dual agonist peptide that we believe offers the potential for the greatest weight loss compared to all obesity management medications currently marketed or in development with a tolerability profile that is class-like or better. We are expanding our ribupatide franchise by developing a once-daily oral tablet formulation, oral ribupatide, based on the same peptide as injectable ribupatide, to provide a convenient oral option with the potential for highly differentiated tolerability with compelling weight loss among oral treatments. Additionally, we are advancing a second oral product candidate, KAI-7535, a once-daily small molecule GLP-1 receptor agonist with the potential to improve on the clinical profile of existing oral treatments. Finally, we are developing KAI-4729, a once-weekly injectable GLP-1/GIP/glucagon receptor tri-agonist, that leverages an incremental mechanism to potentially deliver compelling weight loss, improved liver fat reduction and a differentiated tolerability profile. KAI-4729 is based on a different peptide than injectable ribupatide and oral ribupatide. Obesity is a chronic, complex disease characterized by the accumulation of excessive body fat, resulting in significant negative impacts on health and quality of life. The most severely impacted patient population, people with a body mass index, or BMI, of 35 kg/m2 or greater, which we refer to as a BMI of 35+, represents the fastest growing and largest segment of this population, with half of U.S. adults with obesity expected to have a BMI of 35+ by 2030. While the approvals of GLP-1-based obesity management medications have changed the landscape of obesity management, there remains a critical need for medications offering greater weight loss, especially for those living with a higher BMI. For example, in the SURMOUNT-1 Phase 3 clinical trial, the majority of patients who had a baseline BMI of 35+ and were treated with tirzepatide, the most prescribed weight loss medicine today, were still living with obesity at the end of treatment. Both physicians and patients have identified expected weight loss as a primary treatment goal, with the magnitude of weight reduction serving as a crucial driver in therapy selection. We believe that injectable treatments will remain foundational for patients needing significant weight reduction. Meanwhile, for patients with a lower BMI, lower incidences of gastrointestinal side effects may be needed to achieve optimal weight loss and treatment persistence, and we believe oral treatments can unlock adoption for those with more modest weight loss needs, while also supporting the chronic treatment journey of those living with higher BMIs. We were originally incorporated under the laws of the State of Delaware on May 8, 2024 under the name Hercules CM Newco, Inc. We changed our name to Kailera Therapeutics, Inc. on August 22, 2024. Our principal executive offices are located in Waltham, Massachusetts.
