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ALAMEDA, Calif. - Vivani Medical, Inc. (NASDAQ: VANI), a biopharmaceutical company with a market capitalization of $61.6 million, has announced the successful administration of its GLP-1 (exenatide) implant in the first patient of the LIBERATE-1 clinical trial, signaling progress in the treatment of chronic weight management and type 2 diabetes. According to InvestingPro data, the company’s stock currently trades at $1.04, near its 52-week low, while analyst price targets range from $3 to $8, suggesting potential upside if the trial succeeds. The company also reported rapid enrollment for the trial, with all 24 participants beginning the 8-week run-in period promptly, indicating strong interest in the new six-month, subdermal implant. Top-line results from the study are expected in mid-2025.
The LIBERATE-1 trial, conducted at two centers in Australia, is a Phase 1 study aimed at assessing the safety, tolerability, and pharmacokinetics of the NPM-115 implant. Participants were titrated on semaglutide injections before being randomized to receive either the exenatide implant, weekly exenatide injections, or weekly semaglutide injections for nine weeks. The implant has shown comparable preclinical weight loss to semaglutide, the active ingredient in Ozempic®/Wegovy®.
Vivani’s CEO, Dr. Adam Mendelsohn, emphasized the potential of their technology to improve medication adherence, which is a significant issue in managing chronic diseases. The NanoPortal™ platform is designed to release medication steadily over extended periods, which could enhance efficacy and minimize side effects caused by missed doses. This innovative approach could redefine treatment paradigms by offering a more convenient alternative to daily or weekly dosing.
The company’s research may benefit from the Australian government’s R&D incentives and rebates, and the data generated is expected to be acceptable to the U.S. Food and Drug Administration and other regulatory authorities. Vivani plans to use the clinical data to support regulatory submissions in various geographies, including the United States.
Vivani Medical is leveraging its proprietary technology to develop a portfolio of biopharmaceutical implants for chronic diseases, with a focus on chronic weight management and type 2 diabetes. Their lead program, NPM-115, is under development alongside other implants, including NPM-139 for chronic weight management with the potential for once-yearly administration. With the next earnings report due on March 27, 2025, investors can gain deeper insights into the company’s progress through InvestingPro, which offers exclusive financial metrics and 8 additional ProTips about Vivani’s market position and financial health.
This article is based on a press release statement from Vivani Medical, Inc.
In other recent news, Vivani Medical, Inc. has announced its intention to spin off its division, Cortigent, Inc., into a separate publicly traded company. This strategic move is designed to streamline operations and maximize shareholder value by allowing each entity to focus on distinct strategic goals. Cortigent, which focuses on neurostimulation technology, has completed a six-year clinical study showing promising results, and its CEO, Jonathan Adams, will continue to lead the company post-spin-off. Vivani plans to file a Form 10 registration statement with the SEC, aiming for the spin-off to be completed by the third quarter of 2025, with Vivani stockholders receiving shares in the new entity.
In parallel, Vivani has commenced the LIBERATE-1 clinical trial in Australia for its exenatide implant, marking a significant advancement in obesity treatment. The trial will assess the safety, tolerability, and pharmacokinetics of the implant, with top-line data expected by mid-2025. H.C. Wainwright has reiterated a Buy rating on Vivani, with a price target of $3.00, reflecting confidence in the potential market impact of Vivani’s developments. The firm highlights the convenience of Vivani’s biannual administration, which could offer efficacy comparable to widely used treatments like semaglutide. Vivani is leveraging Australian government incentives to offset some trial costs and plans to use the data to support regulatory submissions in various regions.
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