Vivani Medical Updates Business and Reports Q2 2024 Financials

Vivani Medical, Inc., a biopharmaceutical company specializing in miniaturized, long-acting drug implants, has announced its financial results for the second quarter ending June 30, 2024. The company also provided updates on its business progress and future plans.

CEO Adam Mendelsohn, Ph.D., noted significant strides in the development of Vivani’s GLP-1 implants designed for obesity and chronic weight management. These advancements included addressing the FDA’s requests for further information and receiving clearance for the NPM-119 Investigational New Drug Application. The company is preparing to begin its first human clinical study in the fourth quarter of 2024.

Vivani is developing a unique portfolio of long-acting GLP-1 implants, which could overcome challenges related to medication adherence and tolerability. Notably, around 50% of patients with chronic diseases fail to adhere to their prescribed medication regimens. Moreover, a recent study indicates that a significant percentage of patients using Wegovy (semaglutide) for weight management discontinue the therapy within the first two years, often leading to a rapid reversal of health benefits.

Recent business highlights include the announcement of positive weight loss data for OKV-119, a GLP-1 implant for veterinary use in cats, reported in BMC Veterinary Research. This development underscores the promise of Vivani’s NanoPortal™ implant technology in managing obesity in animals. Additionally, the FDA has cleared the Investigational New Drug Application for NPM-119, a six-month subdermal GLP-1 implant aimed at addressing medication non-adherence in type 2 diabetes patients. The forthcoming first-in-human clinical study will evaluate the safety and efficacy of the exenatide implant compared to marketed injectables.

Vivani is also prioritizing the development of its obesity and chronic weight management programs. The company plans to evaluate its GLP-1 implant in a study named LIBERATE-1, which will include patients who are obese or overweight. Participants will initially receive weekly semaglutide before being randomized to different treatment groups for a nine-week period. This study is expected to commence in Australia in the fourth quarter of 2024, pending regulatory approval, with results anticipated in 2025.

The company has outlined several anticipated milestones. These include obtaining approval from an Australian Human Research Ethics Committee to start its first human study for the NPM-115 obesity implant program and participating in various industry and investor conferences such as the H.C. Wainwright conference in September 2024 and Maxim’s Virtual Healthcare Summit in October 2024.

Financially, as of June 30, 2024, Vivani held $26.3 million in cash, cash equivalents, and restricted cash, down from $31.0 million as of March 31, 2024. The reduction in cash was largely due to a net loss of $5.4 million for the quarter. Research and development expenses decreased by 9% to $3.5 million compared to the same period in 2023, while general and administrative expenses saw a notable reduction of 31% to $2.2 million. This decrease was primarily due to staffing reductions and lowered reliance on external services. The net loss for the quarter was $5.3 million, compared to $6.5 million in the same quarter of the previous year.

Vivani Medical, leveraging its proprietary NanoPortal platform, aims to develop drug implants that deliver medication consistently over extended periods, thereby improving patient adherence and treatment efficacy. Its leading program, NPM-115, is a six-month subdermal GLP-1 (exenatide) implant for chronic weight management in obese or overweight patients. The company's pipeline also includes NPM-139, a semaglutide implant potentially offering once-yearly administration for chronic weight management, and NPM-119 for type 2 diabetes treatment.

Vivani’s wholly-owned subsidiary, Cortigent, Inc., focuses on precision neurostimulation systems to aid patients in regaining crucial bodily functions. Noteworthy developments include the Orion system for artificial vision and a new device to enhance recovery of arm and hand functions post-stroke.

Overall, Vivani Medical is poised to make significant strides in the field of biopharmaceutical implants, with several promising developments on the horizon aimed at improving patient outcomes in chronic disease management.