ALAMEDA, Calif. - Vivani Medical, Inc. (NASDAQ: VANI), a biopharmaceutical company, received approval from the Bellberry Human Research Ethics Committee and acknowledgment from the Therapeutic Goods Administration in Australia for its first-in-human clinical trial. This trial will test the safety and pharmacokinetics of a new GLP-1 (exenatide) implant in overweight and obese individuals.
The trial, named LIBERATE-1, is set to begin in the fourth quarter of 2024 and will evaluate the implant's safety, tolerability, and pharmacokinetic profile. This represents the first clinical application of Vivani's NanoPortal drug implant technology, which aims to offer twice-yearly administration to improve patient adherence to medication regimes.
The study will enroll participants who will initially undergo 8 weeks of weekly semaglutide injections before being randomized to receive either the exenatide implant, weekly exenatide injections, or continued semaglutide injections for 9 weeks. The primary focus will be on changes in weight, with results expected in 2025.
Vivani's President and CEO, Adam Mendelsohn, Ph.D., expressed confidence in the potential of the GLP-1 implant to match the efficacy of semaglutide, currently found in Ozempic® and Wegovy®, but with the added convenience of less frequent dosing. The company plans to leverage Australian research incentives to offset trial costs and anticipates using the data for regulatory submissions in other regions, including the United States.
Vivani's pipeline includes other long-acting implants, such as the NPM-139 (semaglutide) implant, which may offer annual administration, and the NPM-119 for Type 2 Diabetes management. These developments are part of Vivani's strategy to address the widespread issue of medication non-adherence, which poses significant health and economic burdens.
This announcement contains forward-looking statements and the company cautions reliance on these projections. The information is based on a press release statement by Vivani Medical, Inc.
In other recent news, Vivani Medical has been making significant advancements. The company's Annual Meeting of Stockholders resulted in the re-election of six directors, and the ratification of BPM LLP as its independent registered public accounting firm for the fiscal year ending December 31, 2024. Among the elected directors are Gregg Williams, Aaron Mendelsohn, Dean Baker, Alexandra Larson, Adam Mendelsohn, and Daniel Bradbury.
In addition to these corporate decisions, Vivani Medical has also made progress in its clinical endeavors. The company has received FDA approval for Phase 1 clinical trial of its diabetes treatment implant, NPM-119. This development marks the company's transition into a clinical-stage company and the debut of its NanoPortal™ technology in clinical applications.
The LIBERATE-1 study, which will use the NPM-119 implant, aims to improve treatment for patients with type 2 diabetes. Furthermore, Vivani Medical is also developing other drug implants, including NPM-115 for chronic weight management, and NPM-139, a semaglutide implant, for potential once-yearly treatment duration. These are the recent developments in Vivani Medical's pursuit of innovative treatments for chronic diseases.
InvestingPro Insights
As Vivani Medical, Inc. embarks on its pioneering clinical trial for the new GLP-1 implant, investors and industry watchers are keeping a close eye on the company's financial health and market performance. According to InvestingPro data, Vivani Medical has a market capitalization of $65.15 million, reflecting its current standing in the market. The company's P/E ratio stands at -2.53, indicating that investors are willing to incur losses in anticipation of future growth.
InvestingPro Tips highlight that Vivani Medical is quickly burning through cash and suffers from weak gross profit margins, which could be areas of concern for potential investors. The company's stock price movements have been quite volatile, with a 1-month price total return of -12.59%, showcasing the market's reaction to recent events and announcements. On a more positive note, Vivani's liquid assets exceed its short-term obligations, suggesting the company has a cushion for its immediate financial needs.
For those interested in a deeper analysis, InvestingPro offers additional tips on Vivani Medical, Inc. These tips provide insights into the company's operational and financial nuances, which could be crucial in making informed investment decisions. To explore these further, visit https://www.investing.com/pro/VANI, where you'll find a comprehensive list of additional tips to guide your investment strategy.
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