Vivani Medical Stock Price, News & Analysis

Vivani Medical (Nasdaq: VANI) has announced plans to initiate clinical trials for NPM-139, their semaglutide implant for chronic weight management. The company plans to begin a Phase 1 study in the first half of 2026, pending regulatory clearance, followed by a Phase 2 study.

The NPM-139 implant, utilizing NanoPortal™ technology, aims to provide Wegovy®-level efficacy with just once or twice-yearly administration. The Phase 1 study will evaluate safety, tolerability, and pharmacokinetics in GLP-1 naïve obese or overweight subjects, with low-dose Wegovy as control. The subsequent Phase 2 study will be a randomized, placebo-controlled, dose-ranging investigation over 4-6 months.

Vivani Medical (NASDAQ: VANI), a clinical-stage biopharmaceutical company, announced that CEO Adam Mendelsohn will present at the H.C. Wainwright 27th Annual Global Investment Conference on September 10, 2025, in New York.

The presentation will showcase Vivani's portfolio of miniature, ultra long-acting drug implants powered by their proprietary NanoPortal™ technology. The company's focus is on addressing medication adherence in chronic disease management, with particular emphasis on NPM-139, a novel semaglutide implant scheduled for clinical development in 2026, pending regulatory approval.

Vivani Medical (NASDAQ: VANI) announced significant developments including a $10M equity financing through a private placement of 7.9M shares at $1.26 per share. The company reported promising results for its semaglutide implant NPM-139, which demonstrated ~20% weight loss maintained over six months in preclinical studies. The financing extends their runway into H2 2026.

Key developments include positive results from the LIBERATE-1 Phase 1 clinical study of NPM-115, plans to initiate NPM-139 clinical trials in 2026, and the upcoming spin-off of Cortigent as an independent public company. Q2 2025 financial results showed a cash balance of $8.1M, with R&D expenses increasing 35% to $4.8M and a net loss of $7.1M.

Vivani Medical (NASDAQ:VANI) reported significant progress in its drug implant development programs. The company announced positive results from two key studies: the LIBERATE-1 Phase 1 clinical study of NPM-115 (exenatide implant) and preclinical data for NPM-139 (semaglutide implant).

The LIBERATE-1 study met its primary objectives, demonstrating safety and tolerability of the NanoPortal™ implant technology. More notably, the NPM-139 preclinical study showed approximately 20% weight loss maintained for over 6 months with a single implant administration, suggesting potential for annual dosing.

Based on these results, Vivani is prioritizing the development of NPM-139, with clinical trials expected to begin in 2026. The decision is supported by the strong commercial performance of semaglutide-based products, which generated over $29B in sales in 2024.

Vivani Medical (NASDAQ: VANI), a clinical-stage biopharmaceutical company focused on miniature drug implants, has appointed Anthony Baldor as its new Chief Financial Officer, replacing retiring CFO Brigid A. Makes. Baldor brings over 20 years of biotech financial management experience, having previously served as CFO at Diakonos Oncology and VP of Corporate Strategy at 4D Molecular Therapeutics. His track record includes successful fundraising through Series financings, IPO execution, and strategic partnerships. Baldor holds an MBA and Master of Data Science from UC Berkeley. Makes, who played a crucial role in Vivani's merger with Second Sight Medical Products and advancement of clinical strategy, will remain as an advisor during the transition period.

Vivani Medical (NASDAQ: VANI) announced that CEO Adam Mendelsohn will present at the 2025 BIO International Convention in Boston on June 18, 2025. The presentation will showcase Vivani's NanoPortal™ drug implant technology, which focuses on developing miniature, ultra long-acting drug implants to improve medication adherence in chronic disease management. The company's leading product, NPM-115, is a six-month GLP-1 implant using exenatide for chronic weight management in obese or overweight individuals. Results from their first human clinical trial, LIBERATE-1™, are anticipated later in 2025.

Vivani Medical (NASDAQ: VANI) has announced plans to spin off its neurostimulation subsidiary, Cortigent, as an independent Nasdaq-listed company in Q3 2025. Cortigent has filed a Form 10 registration statement with the SEC for this purpose. The spin-off will create two focused companies: Cortigent will develop brain implant devices, including the Orion® Visual Cortical Prosthesis System for the blind and the Stroke Recovery System for post-stroke paralysis recovery. Vivani will focus on developing NanoPortal™ drug implants, specifically GLP-1 implants for weight management and type 2 diabetes. Cortigent's Orion system has FDA Breakthrough Device designation and completed a six-year Early Feasibility Study in March 2025. The transaction aims to provide investors with greater visibility into each company's operations and create long-term value through dedicated management teams and focused strategic priorities.

Vivani Medical (NASDAQ: VANI) reported Q1 2025 financial results and secured additional funding through equity financing. The company raised $3M at $1.03 per share, following an earlier $8.25M raise at $1.12 per share, extending their financial runway into mid-2026. Their LIBERATE-1™ study, testing NPM-115 (exenatide implant) in obese/overweight individuals, achieved successful implant insertions with top-line results expected mid-2025. Vivani released promising pre-clinical data for NPM-139 (semaglutide implant) and expanded their collaboration with Okava Pharmaceuticals to include dogs. The company plans to spin off Cortigent, Inc., their brain implant division, as a separate public company. Q1 2025 financials show a cash balance of $14.3M, with a net loss of $6.3M compared to $6.0M in Q1 2024. R&D expenses increased 13% to $4.2M, while G&A expenses decreased 6% to $2.3M.

Vivani Medical (NASDAQ: VANI) announced its CEO Adam Mendelsohn's upcoming participation in the American Association of Pharmaceutical Scientists' virtual workshop "Beyond GLP1s: Where the Science will Take Business Next" on May 13-14, 2025. Dr. Mendelsohn will present on "Addressing Patient Adherence: Advances in Drug Delivery" on May 14 at 11:15 am ET, focusing on Vivani's miniature drug implants and their proprietary NanoPortal™ technology.

The company's lead program, NPM-115, is a six-month GLP-1 (exenatide) implant for weight management, with results from the LIBERATE-1™ human study expected this year. Dr. Mendelsohn will also participate in a panel discussion at 2:00 pm ET about key hurdles and trends in GLP-1 drug class development.