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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 reported Q3 2024 financial results and secured $5M equity financing through private stock sale at $1.26 per share. The company received regulatory approval to initiate LIBERATE-1, its first-in-human study of a miniature GLP-1 implant in Australia. Preclinical results showed 82% liver fat reduction in obese mice. Q3 financial highlights include: cash position of $21.0M, R&D expenses of $4.2M (down 5% YoY), G&A expenses of $2.1M (down 22% YoY), and net loss of $6.0M (improved from $6.8M YoY). The new financing extends runway into late 2025.
Vivani Medical (NASDAQ: VANI), a biopharmaceutical company developing miniaturized, ultra long-acting drug implants, has announced its participation in two upcoming events in October 2024:
1. Partnership Opportunities in Drug Delivery (PODD) in Boston on October 28-29, 2024. CEO Dr. Adam Mendelsohn will participate in a panel discussion on 'Targeted and Long Acting Delivery; Sustained Release Innovations to Reduce Patient Burden' on October 29 at 3:35 p.m. ET.
2. ThinkEquity Conference in New York on October 30, 2024. Dr. Mendelsohn will provide a company update at 2:30 p.m. ET. A webcast of this presentation will be available on Vivani's corporate website and via a provided link.
Both events offer opportunities for Vivani to showcase its innovative drug delivery technology and provide updates on its progress.
Vivani Medical (Nasdaq: VANI) has received regulatory approval to initiate its first human clinical trial for a GLP-1 (exenatide) implant in obese and overweight individuals in Australia. The trial, named LIBERATE-1™, will test the safety, tolerability, and pharmacokinetic profile of the implant, which is designed to provide comparable efficacy to semaglutide (Ozempic®/Wegovy®) with twice-yearly administration.
The study will involve 24 participants randomized into three groups: Vivani's exenatide implant, weekly exenatide injections, or weekly semaglutide injections. The trial is expected to start in Q4 2024, with data projected for 2025. This marks the first clinical application of Vivani's proprietary NanoPortal™ drug implant technology, aimed at addressing medication non-adherence and potentially improving treatment tolerability through steady drug delivery.
Vivani Medical (NASDAQ: VANI), a biopharmaceutical company developing miniaturized, ultra long-acting drug implants, will present at the Emerging Growth Conference on September 25, 2024. The interactive online event will feature a company overview by President and CEO Adam Mendelsohn, Ph.D., followed by a potential Q&A session.
Investors, advisors, and analysts are invited to attend the presentation scheduled for 1:10 p.m. Eastern Time, lasting 30 minutes. Attendees can register via the provided link to participate and receive updates. Questions can be submitted in advance to Questions@EmergingGrowth.com.
An archived webcast will be available after the conference on EmergingGrowth.com and the Emerging Growth YouTube channel.
Vivani Medical (Nasdaq: VANI) has reported positive preclinical liver fat results for its exenatide implant, a miniature, ultra long-acting GLP-1 drug delivery system. The implant demonstrated an 82% reduction in liver fat compared to a sham implant in an obese mouse model. This result complements previously announced 20% weight loss data, comparable to semaglutide injections.
The company's NPM-115 program, focusing on obesity and chronic weight management, is on track to begin clinical trials in Q4 2024. The LIBERATE-1™ study will evaluate the exenatide implant against weekly injections of exenatide and semaglutide in obese and overweight patients. Vivani aims to address medication non-adherence and improve tolerability with its implant technology.
Vivani Medical (Nasdaq: VANI), a biopharmaceutical company developing miniature, ultra long-acting, subdermal drug implants, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference from September 9-11, 2024 in New York. CEO Adam Mendelsohn will host one-on-one investor meetings and deliver a company overview presentation on September 11, 2024, at 10 a.m. ET in the Adams Room at Lotte New York Palace.
The presentation will be accessible via webcast and on Vivani's website. This event provides an opportunity for Vivani to showcase its innovative drug delivery technology to potential investors and industry professionals, potentially impacting its market position and investor relations.
Vivani Medical (Nasdaq: VANI) reported Q2 2024 financial results and provided a business update. Key highlights include:
- Initiation of NPM-115 clinical program expected in Q4 2024, evaluating a miniature, subdermal GLP-1 implant for obesity
- FDA clearance of IND for NPM-119, advancing the GLP-1 implant portfolio
- Cash position of $26.3 million, supporting operations into H2 2025
- Q2 2024 net loss of $5.3 million, down from $6.5 million in Q2 2023
- R&D expenses decreased 9% to $3.5 million, while G&A expenses reduced 31% to $2.2 million
The company aims to address medication non-adherence and improve tolerability in obesity and chronic weight management with its long-acting GLP-1 implants.
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.
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