Business
Vivani Medical Provides Business Update and Reports Second Quarter 2024 Financial Results
Initiation of the NPM-115 clinical program expected in the fourth quarter of 2024 with a first-in-human study evaluating a miniature, subdermal GLP-1
About this update from Vivani Medical, Inc.
[{"type":"text","content":"\nInitiation of the NPM-115 clinical program expected in the fourth quarter of 2024 with a first-in-human study evaluating a miniature, subdermal GLP-1 (exenatide) implant in obese or overweight patients\n\n\nFDA provided clearance of the Investigational New Drug Application for NPM-119, providing further confidence to advance the Company’s emerging portfolio of GLP-1 implants into clinical phase development\n\n\nSolid financial position supports operations into the second half of 2025 and potential delivery of key portfolio milestones\n\n\n ALAMEDA, Calif.--(BUSINESS WIRE)--\nVivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”), a biopharmaceutical company developing miniaturized, long-acting drug implants, today reported financial results for the second quarter ended June 30, 2024, and provided a business update.\n\n\nVivani’s Chief Executive Officer Adam Mendelsohn, Ph.D., stated, “During the second quarter we achieved significant progress toward advancing the development of our proprietary, GLP-1 implants for obesity and chronic weight management, and anticipate the initiation of our first-in-human clinical study in the fourth quarter of this year. After successfully addressing the FDA’s requests for additional Chemistry, Manufacturing and Controls information and securing clearance on our NPM-119 Investigational New Drug Application in the first half of this year, Vivani is now on the cusp of transitioning to a clinical-stage development phase biotechnology company, now in position to initiate clinical testing in the fourth quarter of this year.”\n\n\nDr. Mendelsohn added, “Our highly differentiated portfolio of miniature, ultra long-acting GLP-1 implants have the potential to directly address medication non-adherence and tolerability, two significant barriers to achieving optimal therapy for chronic weight management and other chronic diseases. An alarmingly high proportion of chronic disease patients, approximately 50%, do not take their medicine as prescribed in the real world, a statistic which holds for both daily orals as well as weekly injectables. In addition, a recent study has shown that 64% of patients taking the popular GLP-1 therapy Wegovy® (semaglutide for weight management) discontinue therapy within the first year, a number which increases to 76% by year two. Importantly, GLP-1 therapy discontinua...