Vivani Medical: Unlocking Chronic Care Potential With NanoPortal Implants (NASDAQ:VANI) - VANI Stock Research Report

## Executive Summary / Key Takeaways * Vivani Medical is strategically focused on its proprietary NanoPortal technology to develop ultra long-acting, subdermal drug implants addressing significant unmet needs in chronic disease management, particularly medication non-adherence. * The company's lead programs, NPM-115 (exenatide) and NPM-139 (semaglutide), target the massive and growing chronic weight management market, aiming to offer superior adherence and potentially improved tolerability compared to existing daily or weekly injectables. * Recent milestones include successful first implant and full enrollment in the first-in-human LIBERATE-1 trial for NPM-115, with top-line data anticipated in mid-2025, and positive preclinical data for NPM-139 supporting potential once-yearly dosing. * Vivani is pursuing a spin-off of its Neurostimulation division (Cortigent) by Q3 2025 to sharpen focus on the Biopharm pipeline. * Recent equity financings, including approximately $8.25 million in March 2025 and $3.0 million in May 2025, are expected to extend the company's cash runway into the second quarter of 2026, providing capital for ongoing R&D and clinical activities. ## The Silent Epidemic: Medication Non-Adherence and Vivani's Implant Solution Chronic diseases represent a significant global health burden, and a leading cause of poor clinical outcomes is a silent epidemic: medication non-adherence. According to the U.S. CDC, approximately 50% of patients do not take their medicines as prescribed in the real world, a statistic that holds true for both daily oral and weekly injectable therapies. This pervasive issue contributes to over $500 billion in annual avoidable healthcare costs and tragically, 125,000 potentially preventable deaths annually in the U.S. alone. Within this landscape, the market for GLP-1 receptor agonists, used for conditions like type 2 diabetes and chronic weight management, has exploded, with products containing semaglutide alone generating $25 billion in 2024. Yet, even with highly effective weekly injectables like Wegovy (semaglutide), studies show alarming discontinuation rates – 64% within the first year and 76% by the second year. Discontinuation can quickly reverse health benefits. Vivani Medical ($VANI) is a clinical-stage biopharmaceutical company aiming to revolutionize the treatment of chronic diseases by directly addressing this adherence challenge. Formed in August 2022 through the merger of Second Sight Medical Products and Nano Precision Medical (NPM), Vivani inherited both legacy neurostimulation assets and NPM's core NanoPortal drug implant technology. The company has since strategically pivoted to prioritize the development of its Biopharm pipeline, leveraging the NanoPortal platform. Vivani's core technological differentiator is its proprietary NanoPortal implant technology. This platform is designed to enable ultra long-acting, near constant-rate delivery of a broad range of medicines via miniaturized, subdermal implants. The tangible benefits are clear: by providing therapeutic drug levels for up to six months or longer with a single administration, these implants are designed to guarantee medication adherence, effectively eliminating missed doses inherent with oral or injectable regimens. Furthermore, the technology aims to minimize fluctuations in patients' drug levels, which could potentially improve the tolerability profiles for medicines, including GLP-1 receptor agonists, that can cause side effects associated with fluctuating blood concentrations. The strategic "so what" for investors is the potential for NanoPortal technology to carve out a significant niche in large, established markets dominated by less adherent delivery methods. While the GLP-1 landscape is crowded with over 50 new molecular entities in development from pharmaceutical giants like Novo Nordisk (TICKER:NVO) and Eli Lilly (TICKER:LLY), Vivani believes its highly differentiated approach offers a compelling value proposition for patients, prescribers, and payers by improving real-world effectiveness through guaranteed adherence and potentially better tolerability. ## Strategic Focus and Pipeline Advancement Vivani's main priority is the further development of its miniature, ultra long-acting drug implant portfolio, particularly focusing on the obesity market. The company operates two reporting segments: the Biopharm Division and the Neurostimulation Division. As of March 31, 2025, the Biopharm Division represented the substantial majority of the company's assets ($34.70 million out of $35.452 million total assets) and operating expenses ($6.0 million out of $6.557 million total operating expenses for Q1 2025), reflecting its primary strategic focus. Neither segment is currently revenue-producing, and both contribute to the company's net loss. The Neurostimulation Division, which includes assets from the legacy Second Sight business focused on pioneering neurostimulation systems, is undergoing a strategic change. In March 2025, Vivani announced its intent to spin off Cortigent, Inc., its wholly owned subsidiary housing these assets, into a fully independent, publicly traded company. This move, planned for completion during or before Q3 2025, aims to create two focused companies dedicated to driving value in their respective therapeutic areas. Within the prioritized Biopharm division, Vivani is advancing a portfolio of NanoPortal-based drug implant candidates: * NPM-115: A miniature, six-month, high-dose exenatide implant for chronic weight management. This is Vivani's lead program and is currently in clinical-stage testing. * NPM-139: A semaglutide implant also in development for chronic weight management. Preclinical data reported in March 2025 showed nearly 20% placebo-adjusted weight loss in healthy rats from a single administration over 91 days, with pharmacokinetic data demonstrating continuous and steady semaglutide exposure. In vitro stability data exceeding one year indicates the potential for once-yearly administration, a significant differentiator in the market. * NPM-119: An exenatide implant in development for the treatment of type 2 diabetes. An IND was initially placed on clinical hold in August 2023 but the hold was lifted in June 2024 after Vivani provided additional CMC information. * OKV-119: Another GLP-1 based implant in development for cardiometabolic disorders in cats and dogs, in collaboration with animal health partner Okava Pharmaceuticals. This collaboration was expanded in April 2025 to include dogs. The strategic shift to prioritize obesity programs in February 2024 was underpinned by positive preclinical data for the exenatide implant (NPM-115) that showed weight loss comparable to semaglutide in an obese mouse model. Further preclinical data in September 2024 demonstrated significant liver fat reduction (82% adjusted reduction) with the exenatide implant in an obese mouse model, consistent with published semaglutide results. ## Clinical Progress and Upcoming Catalysts A key operational focus has been the advancement of the LIBERATE-1 clinical trial for NPM-115. This first-in-human study, initiated in Australia at the end of 2024, was redesigned to evaluate the safety, tolerability, and pharmacokinetic profile of the exenatide implant in obese and overweight individuals. The trial design involves an 8-week titration period on weekly semaglutide injections before randomization to receive either Vivani's exenatide implant, weekly exenatide injections, or weekly 1 mg semaglutide injections for a 9-week treatment duration, with changes in weight being measured. A significant milestone was achieved in March 2025 with the successful administration of the first NPM-115 implant and the rapid full enrollment of the LIBERATE-1 study within just four weeks. This rapid enrollment signals potential early interest in the six-month subdermal GLP-1 implant concept. Consistent with previous guidance, top-line results from the LIBERATE-1 study are anticipated to be reported in mid-2025. This represents a critical near-term catalyst for the company, providing the first human data on the NanoPortal technology and informing the future development path for both NPM-115 and NPM-139. ## Financial Performance and Liquidity As a clinical-stage biopharmaceutical company with no revenue, Vivani has incurred recurring operating losses and negative operating cash flows since inception. For the three months ended March 31, 2025, the company reported a net loss of $6.302 million, compared to $6.039 million for the same period in 2024. Operating expenses totaled $6.557 million in Q1 2025, a 5% increase from $6.227 million in Q1 2024. This increase was primarily driven by a 13% rise in research and development expenses ($4.217 million vs. $3.726 million), reflecting the increased focus and investment in the Biopharm pipeline, partially offset by a 6% decrease in general and administrative expenses ($2.340 million vs. $2.501 million).

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\ Cash used in operating activities for the three months ended March 31, 2025, was $5.163 million, an increase from $4.512 million in the prior year period, consistent with the increase in R&D spend. As of March 31, 2025, cash and cash equivalents stood at $13.008 million, down from $18.352 million at December 31, 2024. Vivani's operations have historically been funded through equity sales. The company has actively raised capital to support its development programs. This includes $13.7 million in net proceeds from a registered direct offering in March 2024, $5.0 million from a private sale transaction in November 2024, approximately $8.25 million expected from a private placement announced in March 2025, and approximately $3.0 million expected from a private sale transaction announced in May 2025. The March 2025 financing is expected to extend the company's cash runway into the second quarter of 2026.

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\ While the company estimates currently available cash provides sufficient funds for at least the next twelve months, its ability to continue as a going concern is dependent on its ability to raise additional capital and/or develop profitable operations. Operating expenses are expected to increase significantly as clinical trials progress and R&D activities expand. ## Competitive Landscape and Risks Vivani operates in highly competitive biopharmaceutical and medical device markets. In the chronic weight management and type 2 diabetes space, it competes with large pharmaceutical companies like Novo Nordisk (TICKER:NVO) and Eli Lilly (TICKER:LLY) that dominate the market with established injectable GLP-1 products. While these competitors possess vast resources, global distribution networks, and significant market share (NVO and LLY together hold a substantial portion of the GLP-1 market), Vivani's competitive edge lies in its NanoPortal technology's potential to offer superior medication adherence and potentially improved tolerability through steady drug delivery. This technological differentiation could allow Vivani to capture market share among patients struggling with adherence or experiencing side effects from fluctuating drug levels, despite its current preclinical/early clinical stage and lack of scale compared to these giants. Other medical device companies like Medtronic (TICKER:MDT) and Abbott Laboratories (TICKER:ABT) also operate in implantable device markets, but Vivani's specific focus on long-acting drug delivery via miniaturized subdermal implants using NanoPortal technology provides a distinct approach compared to their broader device portfolios (e.g., insulin pumps, neural prostheses). Vivani's patent portfolio related to its NanoPortal technology offers a degree of protection in its niche. However, Vivani faces significant risks inherent to its stage of development. The need for substantial additional financing is ongoing, and there is no assurance that capital will be available on favorable terms or at all, which could force delays or termination of development programs. Clinical trials are time-consuming, expensive, and uncertain, and there is no guarantee that the LIBERATE-1 trial or future studies will generate sufficient data for regulatory approval. Even if approved, commercial success is not assured, and the company would face significant expenses for sales, marketing, and distribution infrastructure. Operating as a public company in a regulated industry also incurs substantial costs. Furthermore, the company is involved in ongoing litigation related to a terminated MOU with Pixium Vision SA, which, while not currently deemed to have a material effect on financial statements, adds legal risk and potential costs. Global economic and geopolitical factors could also adversely impact operations and financing capabilities. ## Conclusion Vivani Medical is at a pivotal stage, having strategically focused its resources on the promising NanoPortal drug implant technology, particularly within the high-value chronic weight management market. The core investment thesis hinges on the NanoPortal platform's potential to address the critical issue of medication non-adherence and potentially improve tolerability, offering a differentiated solution in a market dominated by injectables with known adherence challenges. The successful initiation and full enrollment of the LIBERATE-1 trial for NPM-115 and the positive preclinical data for NPM-139 underscore the progress being made. The anticipated top-line data from LIBERATE-1 in mid-2025 represents a key near-term catalyst that will provide crucial insights into the platform's performance in humans. Coupled with the strategic spin-off of the Neurostimulation business and recent financings extending the cash runway, Vivani is positioning itself to advance its prioritized Biopharm pipeline. While significant risks remain, particularly concerning future financing needs and clinical trial outcomes, the potential for the NanoPortal technology to disrupt chronic disease treatment by ensuring adherence presents a compelling long-term opportunity for investors willing to accept the risks of a clinical-stage biotechnology company.