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Vivani Medical Announces Positive NPM-115 Preclinical Weight Loss Data Comparable to Ozempic®/Wegovy® and Discloses NPM-139 as Semaglutide as Strategy Shifts to Prioritize Obesity Portfolio

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Vivani Medical, Inc. (VANI) announces positive preclinical data on NPM-115, a miniature exenatide implant for chronic weight management, showing significant weight loss comparable to semaglutide with twice-yearly dosing. NPM-139, with semaglutide as the active ingredient, offers potential once-yearly dosing. The company aims to prioritize obesity implants for improved health outcomes.
Positive
  • Positive preclinical data on NPM-115 showing significant weight loss in comparison to semaglutide with twice-yearly dosing
  • Disclosed NPM-139 with semaglutide as the active ingredient for potential once-yearly dosing
  • Strategic shift to focus on high-dose GLP-1 implants for obesity treatment based on emerging data
  • Proprietary NanoPortal™ implant technology aims to enhance medication adherence and tolerability
  • Plans to advance development of NPM-115, NPM-139, and other obesity implants for broader potential
Negative
  • None.

The recent preclinical data on Vivani Medical's NPM-115 and NPM-139 implants suggest a significant step forward in chronic weight management treatments. The comparison of NPM-115's weight loss effects to injectable semaglutide, a well-known GLP-1 therapy, indicates a competitive efficacy profile. The twice-yearly and once-yearly dosing regimens for these implants, respectively, could revolutionize patient compliance, addressing one of the major hurdles in chronic disease management.

Furthermore, the use of semaglutide as the active ingredient in NPM-139 aligns with current trends in obesity treatment, where semaglutide has shown substantial benefits. The proprietary NanoPortal™ implant technology could potentially minimize the dosing frequency and improve tolerability, likely leading to better patient outcomes. This technology's success could disrupt the current market for obesity medications, which is characterized by lower adherence rates.

It's important to note that these are preclinical results and the efficacy and safety profile of these implants in humans remain to be seen. The transition from animal models to human trials is complex and unpredictable. However, the potential market impact is significant, considering the high prevalence of obesity and the demand for more convenient treatment options.

Vivani Medical's strategic shift towards obesity implants is a direct response to the burgeoning demand for effective weight management solutions. The obesity treatment market is expanding and the introduction of long-term drug implants could capture a substantial market share, especially if they prove to be more effective or convenient than existing therapies.

The company's focus on medication adherence and tolerability is particularly noteworthy, as these factors are key determinants of a drug's commercial success. The potential for NPM-115 and NPM-139 to offer smooth and steady delivery of GLP-1 therapy could position Vivani Medical as a leader in the sector, pending regulatory approval and successful commercialization.

Investors should monitor the progress of these implants through clinical development, as their success could lead to significant shifts in the competitive landscape of the obesity medication market. The preclinical data may also attract partnerships or funding opportunities, which could further influence Vivani's stock performance and market valuation.

The significance of the preclinical data for NPM-115 and NPM-139 lies in the pharmacological innovation they represent. GLP-1 therapies like semaglutide are already established for weight management, but the challenge of frequent dosing and adherence remains. Vivani's approach, using subdermal implants to deliver these drugs, could enhance the pharmacokinetic profile by ensuring consistent drug levels over extended periods.

From a pharmacological perspective, the supratherapeutic doses used in preclinical studies are designed to maximize weight loss potential. This approach, if translated successfully to human applications, could provide a more pronounced therapeutic effect. However, the safety profile at these higher exposure levels will be crucial to evaluate in future clinical trials.

The potential of these implants to maintain steady drug release profiles could also mitigate the side effects associated with peak-trough fluctuations in drug levels. This steadier release could improve the overall tolerability of GLP-1 therapy, an important consideration for chronic treatments.

NPM-115 (exenatide implant) generated significant weight loss comparable to injectable semaglutide (Ozempic®/Wegovy®) from a single administration with expected twice-yearly dosing

Vivani discloses semaglutide as the active pharmaceutical ingredient in NPM-139, with the added potential benefit of once-yearly dosing

NPM-115 and NPM-139 are miniature, subdermal implants in development for chronic weight management designed to guarantee medication adherence and potentially improve treatment tolerability by providing smooth and steady delivery of GLP-1 therapy

ALAMEDA, Calif.--(BUSINESS WIRE)-- Vivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”), an innovative, preclinical-stage biopharmaceutical company developing novel, long-term drug implants, today announced positive preclinical data on weight loss effects for NPM-115, the Company’s miniature, twice-yearly, exenatide implant under development for the treatment of chronic weight management. The Company also disclosed that semaglutide is the active pharmaceutical ingredient in NPM-139, a miniature, subdermal GLP-1 implant in development for chronic weight management, with the added potential benefit of once-yearly administration. These developments are part of a strategic shift to prioritize the Company’s obesity implants based on emerging data regarding the potential for high-dose GLP-1 products to improve health outcomes for obese and overweight patients.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240228342864/en/

Weight difference from control in healthy Sprague-Dawley Rats. % weight change from baseline for NPM-119 (exenatide) corrected to control (vehicle implant). Values are mean ± SE. (Photo: Business Wire)

Weight difference from control in healthy Sprague-Dawley Rats. % weight change from baseline for NPM-119 (exenatide) corrected to control (vehicle implant). Values are mean ± SE. (Photo: Business Wire)

“In response to tremendous medical need and unprecedented market demand, we are prioritizing the development of our GLP-1 implants for the treatment of obesity and chronic weight management. Since a high-dose GLP-1 implant for obesity would likely also be able to address our previous type 2 diabetes focus, the recently generated compelling weight loss data from NPM-115 naturally supports a shift in focus towards an indication with even broader potential. We believe the primary expected advantages of our proprietary NanoPortal™ implant technology, improving medication adherence and medication tolerability, have the potential to transform and advance the adoption of GLP-1 therapy in the future.” said Adam Mendelsohn, Ph.D., Vivani President and Chief Executive Officer. “The potential for long-term GLP-1 implants becomes even more compelling when you consider that the improved adherence and persistence of Ozempic and Wegovy over prior obesity medications is still only 40% as recently reported in a large retrospective cohort study published in the research journal Obesity. Collectively, the potential for improvement in medication adherence, tolerability and real-world patient outcomes motivates us to rapidly advance the development of NPM-115, NPM-139 and the balance of our portfolio.”

In a study in high-fat diet-induced obese mice, NPM-115 generated weight loss of approximately 20% compared to a sham implant control after a 28-day treatment duration, comparable to weight loss observed in mice treated with semaglutide injections (Ozempic/Wegovy) in the same study. The supratherapeutic doses provided for both NPM-115 (single administration delivering exenatide at ~530 nmol/kg/day), and semaglutide (weekly injections of ~2,700 nmol/kg/week), were selected to maximize the weight-loss potential of both exenatide and semaglutide.

In a second study in healthy rats, a single administration of the Company’s exenatide implant NPM-119, in development for the treatment of type 2 diabetes, resulted in body weights that were approximately 25% lower than a vehicle implant control after 15 weeks of treatment with an expected duration of effect of six months. NPM-119 delivered exenatide at a rate of approximately 320 nmol/kg/day and has demonstrated smooth, non-fluctuating release of exenatide in both in vitro and in vivo studies. NPM-119 has previously demonstrated pharmacokinetic data exhibiting continuous and therapeutic exenatide exposure levels over a six-month duration in healthy rats. Since NPM-115 is a higher-dose version of an otherwise similar product as NPM-119, the durability of the effect on weight demonstrated in this study is expected to translate to future studies utilizing NPM-115.

These preclinical data provide further evidence that the weight loss potential of exenatide treatment in humans may be comparable to other GLP-1 molecules such as semaglutide assuming adequate exposure levels are achieved and maintained. The weight loss potential of exenatide in humans has not been fully evaluated in the currently marketed exenatide products Byetta® (twice-daily injection) and Bydureon® (weekly injection) potentially due to limitations associated with adherence and dosing. NPM-115 directly addresses these limitations. It is designed to improve adherence by enabling patients to receive continuous dosing over a six-month interval from a single administration. NPM-115 is planned to maximize exenatide’s weight loss effect in humans, pending further development and regulatory clearance, by evaluating exenatide exposure levels higher than previously explored.

Dr. Mendelsohn will present study results on May 17 at the TIDES USA 2024 conference in Boston.

About Vivani Medical, Inc.

Leveraging its proprietary NanoPortal™ platform, Vivani Medical develops biopharmaceutical implants designed to deliver drug molecules steadily over extended periods of time with the goal of guaranteeing adherence, and potentially to improve medication tolerability. Vivani’s NPM-115 and NPM-119 are miniature, six-month, GLP-1 implants in development for the treatment of chronic weight management in obese or overweight patients and type 2 diabetes, respectively. Both NPM-115 and NPM-119 are exenatide based products with a higher-dose associated with NPM-115 for the treatment of chronic weight management in obese or overweight patients. An IND for NPM-119’s first-in-human study LIBERATE-1 has been submitted and is on clinical hold pending requests by the FDA for additional chemistry, manufacturing, and controls (CMC) information. Vivani anticipates submitting the requested CMC information to the FDA in the first half of 2024. LIBERATE-1 is a randomized, 12-week investigation of the safety, tolerability, and full pharmacokinetic profile of NPM-119 in patients with type 2 diabetes. Vivani is also preparing to submit an IND for a first-in-human study with NPM-115 for the treatment of chronic weight management later this year. These NanoPortalTM implants are designed to provide patients with the opportunity to realize the full potential benefit of their medication by avoiding the challenges associated with the daily or weekly administration of orals and injectables. Medication non-adherence occurs when patients do not take their medication as prescribed. This affects an alarming number of patients, approximately 50%, including those taking daily pills. Medication non-adherence, which contributes to more than $500 billion in annual avoidable healthcare costs and 125,000 potentially preventable deaths annually in the U.S. alone, is a primary and daunting reason why obese or overweight patients, and patients taking type 2 diabetes or other chronic disease medications face significant challenges in achieving positive real-world effectiveness.

Vivani’s wholly owned subsidiary Cortigent is developing targeted neurostimulation systems intended to help patients recover critical body functions. Investigational devices include Orion®, designed to provide artificial vision to people who are profoundly blind, and a new system intended to accelerate the recovery of arm and hand function in patients who are partially paralyzed due to stroke. Vivani continues to assess strategic options for advancing Cortigent’s pioneering technology.

Forward-Looking Statements

This press release contains certain “forward-looking statements” within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “target,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” and other similar expressions that in this press release, including statements regarding our business, products in development, including the therapeutic potential thereof, plans to address any requests from the FDA related to the agency’s current clinical hold on NPM-119, the initiation of the LIBERATE-1 trial and reporting of trial results, the planned development therefor, our emerging development plans for NPM-115, NPM-139, or our plans with respect to Cortigent and its proposed initial public offering, technology, strategy, cash position and financial runway. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations, and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results and outcomes to differ materially from those indicated in the forward-looking statements include, among others, risks related to the development and commercialization of our products, including NPM-115 and NPM-119; delays and changes in the development of our products, including our ability to address any requests from the FDA related to LIBERATE-1 and to commence clinical development of NPM-119, including as a result of applicable laws, regulations and guidelines, potential delays in submitting and receiving regulatory clearance or approval to conduct our development activities, risks related to the initiation, enrollment and conduct of our planned clinical trials and the results therefrom; our history of losses and our ability to access additional capital or otherwise fund our business; market conditions and the ability of Cortigent to complete its initial public offering. There may be additional risks that the Company considers immaterial, or which are unknown. A further list and description of risks and uncertainties can be found in the Company’s most recent Annual Report on Form 10-K filed with the SEC filed on March 31, 2023, as updated by our subsequent Quarterly Reports on Form 10-Q. Any forward-looking statement made by us in this press release is based only on information currently available to the Company and speaks only as of the date on which it is made. The Company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of added information, future developments or otherwise, except as required by law.

Company Contact:

Donald Dwyer

Chief Business Officer

info@vivani.com

(415) 506-8462



Investor Relations Contact:

Brigid A. Makes

Chief Financial Officer

investors@vivani.com

(415) 506-8462



Media Contact:

Sean Leous

ICR Westwicke

Sean.Leous@westwicke.com

(646) 866-4012

Source: Vivani Medical, Inc.

The ticker symbol for Vivani Medical, Inc. is VANI.

NPM-115 is a miniature exenatide implant for chronic weight management showing significant weight loss comparable to semaglutide with twice-yearly dosing.

Semaglutide is the active pharmaceutical ingredient in NPM-139, a subdermal GLP-1 implant for chronic weight management.

NPM-139 offers the potential benefit of once-yearly dosing for chronic weight management.

The company is prioritizing obesity implants based on emerging data regarding high-dose GLP-1 products for improved health outcomes.
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About VANI

vivani leverages proprietary technologies to develop and commercialize drug and device implants, including its lead asset npm-119 (exenatide implant), which seeks to treat patients with chronic diseases with high unmet medical need.