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On Monday, H.C. Wainwright maintained a positive stance on Vivani Medical (TASE:BLWV), Inc. (NASDAQ: VANI), with analyst Yi Chen confirming a Buy rating and a stable price target of $4.00. The reaffirmation follows Vivani Medical’s announcement of its 2024 financial outcomes earlier this week. The company reported a net loss of $23.5 million, or $0.43 per share, which closely matched the expectations set by H.C. Wainwright at $23.4 million. With a current market capitalization of $58.64 million and trading at $0.99 per share, the stock has experienced a significant decline of over 50% in the past year. InvestingPro data reveals the company is rapidly burning through cash, a critical factor for investors to monitor.
Vivani Medical has recently reached a significant milestone in its clinical development. The company successfully completed full enrollment for its Phase 1 LIBERATE-1 trial of the exenatide implant NPM-115, with 24 participants across two clinical sites in Australia. This development is a critical step forward for the trial, which is slated to deliver topline results by mid-2025. InvestingPro analysis shows the company maintains a healthy current ratio of 3.41, indicating strong short-term liquidity to support its clinical programs. The platform’s Financial Health Score suggests fair operational stability despite development-stage challenges.
NPM-115, the focus of the LIBERATE-1 trial, is gaining attention due to its preclinical performance. The implant has shown weight loss effects comparable to semaglutide injections, the active component in well-known drugs Ozempic and Wegovy. The design of NPM-115 aims for twice-yearly administration, a feature that could enhance patient adherence to the medication regimen, potentially leading to better efficacy. Additionally, the less frequent dosing could minimize tolerability issues and reduce the burden of treatment compared to the daily oral or weekly injectable alternatives.
The successful advancement of NPM-115 through the LIBERATE-1 trial could pave the way for further clinical studies in the United States. Positive results would be a green light for the company to initiate additional trials, bringing the implant one step closer to potential market entry.
H.C. Wainwright’s reiteration of the Buy rating and the $4 price target reflects confidence in Vivani Medical’s progress and the prospects of NPM-115. The analyst’s commentary underscores the potential impact of the treatment on medication adherence and the overall treatment landscape for weight management therapies. According to InvestingPro analysis, the stock appears slightly undervalued at current levels, with additional ProTips and detailed financial metrics available to subscribers.
In other recent news, Vivani Medical, Inc. has raised approximately $8.25 million through a private placement of shares, intended to support the development of its semaglutide and exenatide implants, NPM-139 and NPM-115, respectively. These implants are part of Vivani’s efforts to provide long-acting solutions for chronic weight management and potentially improve medication adherence. In related developments, H.C. Wainwright maintained a Buy rating on Vivani Medical with a $4.00 price target, following positive preclinical data for NPM-139, which showed significant weight reduction in rats over 91 days. The study demonstrated that NPM-139 could maintain therapeutic levels of semaglutide for up to six months, with the potential for once-yearly dosing.
Vivani Medical also reported that its LIBERATE-1 clinical trial for the NPM-115 implant has successfully enrolled all participants, reflecting strong interest in the six-month subdermal implant. The trial aims to assess the safety and pharmacokinetics of the implant in overweight or obese subjects, with top-line results expected in mid-2025. Additionally, the company is benefiting from Australian R&D rebates to offset trial costs, anticipating that the data will be acceptable to regulatory bodies such as the U.S. Food and Drug Administration. Vivani’s CEO, Adam Mendelsohn, highlighted the potential of their NanoPortal technology to transform GLP-1 therapy by enhancing adherence and providing a more convenient treatment option.
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