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Vivani Medical, Inc. (symbol: VANI) is a preclinical-stage biopharmaceutical company specializing in the development of advanced drug and device implants. Leveraging its proprietary NanoPortal technology, Vivani focuses on creating miniaturized, subdermal implants designed to deliver medicines at a near-constant rate over extended periods. This innovative approach aims to address chronic diseases with significant unmet medical needs, ensuring consistent therapeutic effects while enhancing patient compliance.
The company's lead asset, npm-119 (exenatide implant), exemplifies its cutting-edge capabilities. Npm-119 targets the treatment of chronic illnesses, offering a promising solution for patients requiring long-term medication. By providing a steady release of exenatide, npm-119 aims to improve the management of conditions such as diabetes, potentially revolutionizing patient care.
Vivani operates through two main segments: the Biopharm Division and the Neuromodulation Division. The Biopharm Division focuses on the development of drug implants utilizing the NanoPortal technology, while the Neuromodulation Division is dedicated to creating devices that modulate neural activity for therapeutic purposes.
Recent achievements include advancements in their preclinical trials, strategic partnerships to enhance research capabilities, and securing funding to support ongoing projects. These developments underscore Vivani's commitment to pioneering medical innovations that address critical health challenges.
With its robust portfolio and strategic focus, Vivani Medical, Inc. is well-positioned to make significant strides in the biopharmaceutical industry, offering hope to patients with chronic conditions worldwide.
Vivani Medical has announced plans to begin the first clinical study for its NPM-115 program, focused on a 6-month GLP-1 (exenatide) implant for chronic weight management in obese or overweight patients, in Q4 2024 in Australia, pending regulatory approval. The study, named LIBERATE-1, will test the safety, tolerability, and pharmacokinetic profile of the implant. Patients will receive weekly semaglutide injections for 8 weeks before randomization into three treatment groups. Results are expected in 2025. The company has prioritized obesity treatment due to significant medical need and market demand. Positive preclinical data and FDA clearance for a related program (NPM-119) support the initiative.
Vivani Medical has received FDA clearance for its Investigational New Drug Application (IND) and the lifting of a clinical hold on NPM-119, enabling the initiation of the LIBERATE-1 Phase 1 clinical trial. This trial will assess the safety, tolerability, and pharmacokinetics of NPM-119, a miniature six-month GLP-1 implant for type 2 diabetes. The LIBERATE-1 trial will be the first clinical application of Vivani's NanoPortal™ implant technology in humans. NPM-119 aims to address medication non-adherence and improve tolerability issues associated with oral and injectable type 2 diabetes medications. Vivani is also developing NPM-115 and NPM-139 for chronic weight management. The company anticipates starting the LIBERATE-1 trial in the second half of the year.
Vivani Medical (Nasdaq: VANI) announced positive data on its OKV-119 exenatide implant for feline weight loss, published in BMC Veterinary Research. The study highlights that a single OKV-119 implant delivers exenatide over 3 months, leading to significant weight loss in cats. This reinforces the potential of Vivani's NanoPortal™ technology for addressing obesity in both humans and animals. Vivani's development partner, Okava Pharmaceuticals, is exploring the use of OKV-119 for pre-diabetes, diabetes, and obesity in companion felines. The promising results support further clinical evaluations of the implant for chronic weight management in humans.
Vivani Medical (Nasdaq: VANI) has provided a business update and first quarter 2024 financial results. The company is advancing the development of GLP-1 implants for chronic weight management and type 2 diabetes. Key highlights include the initiation of preclinical activities for NPM-115 and the expected IND submission by year-end. A $15-million stock offering in March will fund operations until the second half of 2025. Vivani reported a cash balance of $31.0 million as of March 31, 2024, a net loss of $6.0 million, and a slight reduction in R&D and administrative expenses compared to the previous year.
Vivani Medical, Inc. (Nasdaq: VANI) will present at the TIDES Conference 2024 in Boston to discuss its lead asset NPM-115 for chronic weight management and NPM-119 for type 2 diabetes. The presentation will cover the Company's NanoPortal™ platform and updates on its programs.
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