Business
Vivani Medical Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results
Strategic shift prioritizes the development of GLP-1 implants for the treatment of obesity and chronic weight management Positive NPM-115 (exenatide implant)
About this update from Vivani Medical, Inc.
[{"type":"text","content":"\nStrategic shift prioritizes the development of GLP-1 implants for the treatment of obesity and chronic weight management\n\n\nPositive NPM-115 (exenatide implant) preclinical weight loss data comparable to semaglutide, active ingredient in Ozempic®/Wegovy®\n\n\n$15 million financing round enables acceleration of priority development programs and secures operations into the second half of 2025\n\n\n ALAMEDA, Calif.--(BUSINESS WIRE)--\nVivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”), a biopharmaceutical company developing miniaturized, long-term drug implants including its lead asset NPM-115 for chronic weight management in obese or overweight patients with one or more risk factors, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.\n\n\nAdam Mendelsohn, Ph.D., Vivani’s Chief Executive Officer, stated, “2023 was another remarkable year for Vivani as we shifted our strategic focus to our obesity portfolio and announced that our lead program NPM-115 – a six-month GLP-1 implant for obesity – generated preclinical weight loss data comparable to semaglutide, the active ingredient in Ozempic® and Wegovy®. We also disclosed semaglutide as the active pharmaceutical ingredient in NPM-139, a miniature, subdermal GLP-1 implant in development for chronic weight management, with the added potential benefit of once-yearly administration. In March, we raised funding to support operations into the second half of 2025. Additionally, we moved into a dedicated facility in Alameda, California, capable of supporting the manufacturing of large-scale clinical trial materials and, ultimately, commercial supply.”\n\n\nDr. Mendelsohn added, “We are on track to submit a new Investigational New Drug Application for NPM-115, our high-dose exenatide implant for chronic weight management in obese and overweight patients with one or more risk factors, later this year. We also remain on track to provide the U.S. Food and Drug Administration with the requested NPM-119 Chemistry, Manufacturing and Controls information in the first half of this year, with the goal of obtaining an Investigational New Drug Application clearance of NPM-119 to initiate clinical development. The considerable work we have done to prepare NPM-119 for clinical development will be leveraged as we mo...