Vivani Medical Stock Price, News & Analysis

Vivani Medical (NASDAQ: VANI) has announced two significant milestones in its LIBERATE-1™ clinical trial: the successful first implant of its NPM-115 GLP-1 (exenatide) implant and full enrollment of 24 subjects within four weeks. The miniature, twice-yearly implant is being developed for chronic weight management.

The NPM-115 implant has shown comparable preclinical weight loss results to semaglutide injections (Ozempic®/Wegovy®). The first implant administration was well-tolerated, and top-line study results are expected in mid-2025.

The company's NanoPortal™ platform technology aims to address medication adherence challenges, as approximately 50% of patients regularly miss doses. The LIBERATE-1 study will explore NPM-115's pharmacokinetic profile, which has demonstrated consistent and minimally fluctuating drug release in preclinical studies. The implant could potentially be used for treating type 2 diabetes and other conditions where GLP-1 treatment shows clinical benefit.

Vivani Medical (NASDAQ: VANI) has announced plans to spin off its Cortigent neurostimulation business as an independent publicly-traded company. The spin-off, expected to complete by Q3 2025, aims to create two focused companies dedicated to their respective therapeutic areas.

Cortigent specializes in brain implant devices and is known for developing the Orion® artificial vision system and the FDA-authorized Argus® II Retinal Prosthesis System. The company recently completed a 6-year clinical study for Orion in 2024, showing promising safety and efficacy results. The technology is also being developed for recovery of arm and hand motion in stroke-related paralysis.

Post spin-off, Vivani will focus exclusively on developing miniature, ultra long-acting GLP-1 implants for chronic weight management and type 2 diabetes with once or twice-yearly administration. The transaction is intended to be tax-free for U.S. federal income tax purposes, with Vivani stockholders receiving shares in the new company.

Vivani Medical (NASDAQ: VANI) has initiated its first-in-human clinical trial, LIBERATE-1™, testing a novel GLP-1 (exenatide) implant for obesity and overweight treatment at two Australian centers. The trial marks the first clinical application of their proprietary NanoPortal™ drug implant technology, designed to provide comparable efficacy to semaglutide with twice-yearly administration.

The randomized trial will evaluate safety, tolerability, and pharmacokinetics in participants who will first undergo 8 weeks of semaglutide titration before being randomized into three groups: exenatide implant (n=8), weekly exenatide injections (n=8), or weekly semaglutide injections (n=8) for 9 weeks. Top-line data is expected in mid-2025.

Vivani Medical (NASDAQ: VANI) announced its participation in the Innovation in Obesity Therapeutics Summit West Coast in San Diego from December 10-12, 2024. CEO Adam Mendelsohn will engage in two key sessions:

1. A panel discussion on 'The Obesity Race on the Manufacturing Floor' on December 11 at 2:40 PM PT, addressing supply chain challenges for GLP-1 drugs alongside executives from Regor Therapeutics and Biolexis Therapeutics.

2. A presentation at 4:20 PM PT focusing on the company's NanoPortal™ implant technology and their lead program NPM-119, a six-month GLP-1 (exenatide) implant for chronic weight management. The implants are designed for once or twice-yearly dosing to improve medication adherence and patient tolerability. Clinical data from the LIBERATE-1 study is expected in 2025.

Vivani Medical reported Q3 2024 financial results and secured $5M equity financing through private stock sale at $1.26 per share. The company received regulatory approval to initiate LIBERATE-1, its first-in-human study of a miniature GLP-1 implant in Australia. Preclinical results showed 82% liver fat reduction in obese mice. Q3 financial highlights include: cash position of $21.0M, R&D expenses of $4.2M (down 5% YoY), G&A expenses of $2.1M (down 22% YoY), and net loss of $6.0M (improved from $6.8M YoY). The new financing extends runway into late 2025.

Vivani Medical (NASDAQ: VANI), a biopharmaceutical company developing miniaturized, ultra long-acting drug implants, has announced its participation in two upcoming events in October 2024:

1. Partnership Opportunities in Drug Delivery (PODD) in Boston on October 28-29, 2024. CEO Dr. Adam Mendelsohn will participate in a panel discussion on 'Targeted and Long Acting Delivery; Sustained Release Innovations to Reduce Patient Burden' on October 29 at 3:35 p.m. ET.

2. ThinkEquity Conference in New York on October 30, 2024. Dr. Mendelsohn will provide a company update at 2:30 p.m. ET. A webcast of this presentation will be available on Vivani's corporate website and via a provided link.

Both events offer opportunities for Vivani to showcase its innovative drug delivery technology and provide updates on its progress.

Vivani Medical (Nasdaq: VANI) has received regulatory approval to initiate its first human clinical trial for a GLP-1 (exenatide) implant in obese and overweight individuals in Australia. The trial, named LIBERATE-1™, will test the safety, tolerability, and pharmacokinetic profile of the implant, which is designed to provide comparable efficacy to semaglutide (Ozempic®/Wegovy®) with twice-yearly administration.

The study will involve 24 participants randomized into three groups: Vivani's exenatide implant, weekly exenatide injections, or weekly semaglutide injections. The trial is expected to start in Q4 2024, with data projected for 2025. This marks the first clinical application of Vivani's proprietary NanoPortal™ drug implant technology, aimed at addressing medication non-adherence and potentially improving treatment tolerability through steady drug delivery.

Vivani Medical (NASDAQ: VANI), a biopharmaceutical company developing miniaturized, ultra long-acting drug implants, will present at the Emerging Growth Conference on September 25, 2024. The interactive online event will feature a company overview by President and CEO Adam Mendelsohn, Ph.D., followed by a potential Q&A session.

Investors, advisors, and analysts are invited to attend the presentation scheduled for 1:10 p.m. Eastern Time, lasting 30 minutes. Attendees can register via the provided link to participate and receive updates. Questions can be submitted in advance to Questions@EmergingGrowth.com.

An archived webcast will be available after the conference on EmergingGrowth.com and the Emerging Growth YouTube channel.

Vivani Medical (Nasdaq: VANI) has reported positive preclinical liver fat results for its exenatide implant, a miniature, ultra long-acting GLP-1 drug delivery system. The implant demonstrated an 82% reduction in liver fat compared to a sham implant in an obese mouse model. This result complements previously announced 20% weight loss data, comparable to semaglutide injections.

The company's NPM-115 program, focusing on obesity and chronic weight management, is on track to begin clinical trials in Q4 2024. The LIBERATE-1™ study will evaluate the exenatide implant against weekly injections of exenatide and semaglutide in obese and overweight patients. Vivani aims to address medication non-adherence and improve tolerability with its implant technology.