ALAMEDA, Calif. - Vivani Medical, Inc. (NASDAQ: VANI), a biopharmaceutical company, has received U.S. Food and Drug Administration (FDA) clearance to proceed with a Phase 1 clinical trial for its diabetes treatment implant, NPM-119. This trial, named LIBERATE-1, is set to explore the safety, tolerability, and pharmacokinetics of the implant, which provides a six-month steady delivery of the diabetes drug exenatide.
Today, Vivani Medical transitions into a clinical-stage company as it embarks on its first-in-human study of NPM-119. The trial also marks the debut of NanoPortal™, the company's proprietary implant technology, in clinical applications. According to Vivani's President and CEO, Adam Mendelsohn, Ph.D., the LIBERATE-1 study aims to translate promising preclinical pharmacokinetic profiles into human applications and will compare NPM-119 to the once-weekly exenatide active comparator, Bydureon BCise®.
The study will enroll patients with type 2 diabetes who have previously been treated with GLP-1 therapy, which will be discontinued before they receive either NPM-119 or the active comparator. LIBERATE-1 is a randomized, 12-week investigation that will provide comprehensive pharmacokinetic data.
Vivani is also developing other drug implants, including NPM-115 for chronic weight management, which has shown comparable weight loss to semaglutide injections in preclinical studies. Semaglutide is the active ingredient in the popular products Ozempic® and Wegovy®. Additionally, NPM-139, a semaglutide implant, is in the pipeline with the potential for once-yearly treatment duration.
The NanoPortal technology aims to ensure medication adherence and improve patient outcomes for chronic diseases such as type 2 diabetes and chronic weight management. Medication non-adherence is a significant issue, affecting roughly 50% of patients and contributing to substantial healthcare costs and preventable deaths annually in the U.S.
InvestingPro Insights
As Vivani Medical, Inc. (NASDAQ: VANI) steps into the clinical-stage with its FDA-approved Phase 1 trial for NPM-119, investors are closely monitoring the company's financial health and market performance. Here are some key insights based on the latest data from InvestingPro:
InvestingPro Data indicates a challenging financial landscape for Vivani Medical. With a market capitalization of $89.61 million and a negative P/E ratio of -3.31, reflecting its current non-profitable status, the company's financial metrics highlight the risks associated with investing in early-stage biopharmaceutical firms. Furthermore, the company's EBITDA for the last twelve months as of Q1 2024 stands at -$26.24 million, with an EBITDA growth of -20.22%, pointing towards a declining operational performance during this period.
Despite the financial hurdles, InvestingPro Tips suggest a silver lining. Vivani Medical holds more cash than debt on its balance sheet, which may provide some financial flexibility as it navigates the costly process of drug development and clinical trials. Additionally, the company's liquid assets exceed its short-term obligations, indicating a stable short-term financial position.
However, it's worth noting that analysts do not anticipate Vivani will be profitable this year, and the company is quickly burning through cash. Moreover, the lack of dividend payments to shareholders reflects the typical reinvestment strategy of growth-focused biotech companies, which may deter income-seeking investors.
For those considering an investment in Vivani Medical, it's essential to weigh the potential of the company's NanoPortal™ technology and drug implants against the financial realities presented. Interested investors can find additional insights and metrics on Vivani Medical by visiting https://www.investing.com/pro/VANI. To enhance your research experience, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription at InvestingPro, where 7 additional InvestingPro Tips are available to help guide investment decisions.
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