Proceeds to enable completion of a U.S. FDA pivotal trial for a weight loss indication and commercialization readiness activities, as well as initiation of human studies for a second product focused on glycemic control
BOSTON, Massachusetts, December 18, 2015: Gelesis, a clinical stage biotechnology company focused on the development of first-in-class products to safely induce weight loss and improve glycemic control, announced today that it has closed a $31.5 million growth financing round. New institutional investors, including Cormorant Asset Management, joined current investors Invesco Asset Management, PureTech and the Priztker/Vlock Family Office in this financing round. The financing brings the total capital raised since inception to over $90 million.
Gelesis plans to use the proceeds from the financing to enable completion of a six-month U.S. Food and Drug Administration (FDA) pivotal trial of Gelesis100 with topline data expected to be available in the first half of 2017, as well as to support commercial readiness activities in preparation for a potential launch.
Gelesis100 is a first-in-class, orally administered capsule containing small hydrogel particles designed to employ multiple mechanisms of action along the gastrointestinal tract to safely induce weight loss and improve glycemic control in overweight and obese patients.
In a multicenter, double-blind, placebo-controlled proof-of-concept study, Gelesis100 showed statistically significant weight loss in overweight and obese subjects, with particularly dramatic weight loss in prediabetics. In July 2015, Gelesis announced the expansion of the Gelesis100 GLOW study to multiple U.S. sites, allowing it to serve as a U.S. pivotal trial. The expansion of the GLOW study accelerated the clinical timeline by approximately one year, and Gelesis anticipates enrolling patients in U.S. sites in 2016 and filing for FDA approval in the first half of 2017.
Funds will also be used for the expected completion of first-in-human studies of its glycemic control product, Gelesis200, with anticipated read-out of a three-month proof-of-concept study expected in the second half of 2016. Gelesis200 was created with the same proprietary technology platform as Gelesis100 and its properties are optimized to improve glycemic control in patients with prediabetes and type 2 diabetes who may or may not require weight loss.
“We appreciate the support of Gelesis’ new and existing investors as we aim to bring novel therapies to the market to address the obesity and diabetes epidemics,” said Yishai Zohar, Founder and Chief Executive Officer of Gelesis. “We look forward to completing our U.S. pivotal trial of Gelesis100 and, if approved, we believe it has the potential to address the significant unmet need for an orally dosed, safe and efficacious therapy to induce weight loss and improve glycemic control.”
Gelesis is a clinical stage biotechnology company focused on the development of novel therapies to induce weight loss and improve glycemic control in overweight and obese patients, including those with prediabetes and diabetes. Gelesis100, one of the company’s product candidates and a first-in-class therapeutic, is currently being evaluated in a six-month pivotal study. Gelesis is also developing Gelesis200, created from the same proprietary technology platform as Gelesis100, as a product optimized to improve glycemic control in prediabetics and type 2 diabetics who may or may not require weight loss.
The Gelesis executive and advisory team includes leading experts in obesity and its related comorbidities, clinical research and development, and advanced biomaterials, including Caroline Apovian, M.D., Professor of Medicine and Pediatrics at Boston University School of Medicine; Louis J. Aronne, M.D., FACP, Director of the Comprehensive Weight Control Program at New York-Presbyterian Hospital/Weill Cornell Medical Center; Arne Astrup, M.D., Head of Department of Nutrition, Exercise and Sports at University of Copenhagen; Ken Fujioka, M.D., Director of the Nutrition and Metabolic Research Center and the Center for Weight Management at the Scripps Clinic; Allan Geliebter, Ph.D., Senior Attending Psychologist, St. Luke’s-Roosevelt Hospital; James Hill, Ph.D., Professor of Medicine & Pediatrics, University of Colorado; Lee M. Kaplan, MD, Ph.D., Director of the Obesity, Metabolism & Nutrition Institute, Bennett Shapiro, M.D., Co-founder and Non-Executive Director at PureTech and former Executive Vice President of Research for Merck; and Angelo Tremblay, Ph,D., professor, Department of Kinesiology at Laval University.
Gelesis investors include Cormorant Asset Management, PureTech Health PLC (LSE: PRTC), Invesco Asset Management, the Priztker/Vlock Family Office, and other prominent biotech and finance investors.
PureTech, +1 617 226 4819
Julie DiCarlo, Senior Vice President, Communications and Investor Relations