Vivani Medical Achieves First Implant and Full Enrollment in the First-in-Human Clinical Trial of GLP-1 Implant NPM-115 in Obese or Overweight Adults

Rhea-AI Summary

Vivani Medical (NASDAQ: VANI) has announced two significant milestones in its LIBERATE-1™ clinical trial: the successful first implant of its NPM-115 GLP-1 (exenatide) implant and full enrollment of 24 subjects within four weeks. The miniature, twice-yearly implant is being developed for chronic weight management.

The NPM-115 implant has shown comparable preclinical weight loss results to semaglutide injections (Ozempic®/Wegovy®). The first implant administration was well-tolerated, and top-line study results are expected in mid-2025.

The company's NanoPortal™ platform technology aims to address medication adherence challenges, as approximately 50% of patients regularly miss doses. The LIBERATE-1 study will explore NPM-115's pharmacokinetic profile, which has demonstrated consistent and minimally fluctuating drug release in preclinical studies. The implant could potentially be used for treating type 2 diabetes and other conditions where GLP-1 treatment shows clinical benefit.

Positive

• Successful first implant administration with good tolerability
• Rapid full enrollment (24 subjects) achieved in just 4 weeks
• Preclinical results showed comparable weight loss to established GLP-1 drugs
• Potential to address 50% medication non-adherence rate in current treatments

Negative

• Top-line results not available until mid-2025
• Early-stage clinical trial with subject size (24 participants)
• No human efficacy data available yet

Insights

Medical Device/Biotechnology Expert

Vivani Medical's announcement represents significant milestone progress for their NPM-115 GLP-1 implant program, with both first human implantation and full enrollment of all 24 subjects in their LIBERATE-1 first-in-human trial. The rapid 4-week enrollment suggests strong clinical interest in this novel delivery approach.

The company's NanoPortal technology aims to solve a critical challenge in the $100+ billion GLP-1 market - patient adherence. Unlike daily pills or weekly injections, their twice-yearly implant could eliminate missed doses entirely. Their preclinical data showing weight loss comparable to semaglutide is particularly notable, though human efficacy remains to be demonstrated.

This advancement positions Vivani in the rapidly evolving metabolic disease space with a differentiated approach. While giants like Novo Nordisk dominate with injectable GLP-1s, the persistent adherence problem creates a potential opening. The pharmacokinetic focus of this trial is appropriate at this stage - establishing consistent, sustained drug delivery over 6 months will be important for their value proposition.

With a market cap of just $62 million, Vivani's valuation reflects both the enormous opportunity and significant development risks ahead. The estimated mid-2025 data readout will be pivotal, but represents just the first step in what would be a multi-year clinical development program.

Clinical Research & Regulatory Expert

The successful first implantation and completed enrollment in Vivani's LIBERATE-1 trial marks essential early progress in their clinical program. However, investors should understand this study's specific objectives - it's designed to evaluate pharmacokinetics (how the drug moves through the body), not yet efficacy endpoints like weight loss in humans.

Several aspects of this announcement merit attention. First, the 4-week enrollment period is impressively rapid for a first-in-human study, suggesting strong investigator interest. Second, the initial safety signal regarding tolerability is positive, though based on just a single patient so far.

The regulatory pathway for this implant adds complexity compared to traditional pharmaceuticals. Vivani will need to demonstrate both drug efficacy and device safety/reliability over the full six-month period. Their choice of exenatide (a well-established GLP-1 with known safety profile) is strategically sound from a regulatory perspective, potentially allowing a more streamlined development pathway than a novel compound.

The mid-2025 data timeframe aligns with typical Phase 1 study durations. If successful, the company would still need to conduct larger Phase 2/3 trials focused on efficacy and broader safety. The adherence advantage they highlight addresses a genuine clinical need, as studies show 40-60% of patients struggle with consistent medication use in chronic conditions.

Miniature, twice-yearly GLP-1 (exenatide) implant under development for chronic weight management

NPM-115 has demonstrated comparable preclinical weight loss to injections of semaglutide, the active ingredient in Ozempic®/Wegovy®

Rapid full study enrollment with all 24 subjects initiating the 8-week run-in period within four weeks; top-line study results expected in mid-2025

ALAMEDA, Calif.--(BUSINESS WIRE)-- Vivani Medical, Inc. (NASDAQ: VANI) (“Vivani” or the “Company”), a clinical-stage biopharmaceutical company developing miniature, ultra long-acting drug implants, today announced the successful administration of its first GLP-1 (exenatide) implant in the LIBERATE-1™ clinical trial. This milestone marks a critical step toward addressing one of healthcare’s most pressing challenges: medication adherence in metabolic diseases including chronic weight management and type 2 diabetes. The Company also announced full enrollment in the LIBERATE-1 study, which was achieved in just four weeks after enrollment of the first subject, signaling early potential interest for this six-month, subdermal GLP-1 implant and reaffirming previous estimates that top-line results should be available in mid-2025.

“We are excited to report that the first dose of the NPM-115 implant was successful. The insertion was well tolerated by the subject. Combined with the achievement of full enrollment in the study, this represents important progress in advancing our GLP-1 implant through clinical development,” said Vivani Chief Executive Officer Adam Mendelsohn, Ph.D. “With obesity affecting more than one billion people globally, our implants could redefine treatment paradigms by providing a convenient therapeutic alternative with significantly reduced dosing frequency compared to daily orals and weekly injectables.

“We also believe our innovative NanoPortal™ platform technology could improve medication adherence and thereby significantly improve patient outcomes,” explained Dr. Mendelsohn. “About half of people regularly miss doses as indicated by real-world medication adherence data. Missed doses not only lead to suboptimal efficacy but can also exacerbate tolerability issues. In fact, manufacturers of marketed, weekly injectable GLP-1 products recommend that a patient consider reinitiating GLP-1 therapy at the initial starting dose if two doses or more are missed, to avoid tolerability issues associated with rapid increases in GLP-1 exposure levels. We believe our miniature, ultra long-acting implants, designed to improve medication adherence, have the potential to improve efficacy and minimize tolerability issues.”

The LIBERATE-1 study is exploring the full pharmacokinetic profile of NPM-115, which has demonstrated consistently smooth and minimally fluctuating drug release both in vitro and in animal models. Successful translation to humans is expected to ultimately demonstrate greater effectiveness and tolerability in otherwise poorly adherent patients, potentially providing a transformative option for chronic weight management patients. Vivani expects these results to support the potential application of this GLP-1 (exenatide) implant in the treatment of type 2 diabetes and other diseases for which GLP-1 treatment has demonstrated, or will demonstrate, clinical benefit.

Bydureon BCise® is a registered trademark under license by AstraZeneca.
Ozempic® and Wegovy® are registered trademarks of Novo Nordisk A/S.

About LIBERATE-1

LIBERATE-1 is a Phase 1, first-in-human study of a miniature, ultra long-acting GLP-1 (exenatide) implant to investigate the safety, tolerability, and full pharmacokinetic profile in obese or overweight subjects. The trial will enroll participants who will be titrated on weekly semaglutide injections for 8 weeks (0.25 mg/week for 4 weeks followed by 0.5 mg/week for 4 weeks) before being randomized to receive a single administration of Vivani’s exenatide implant (NPM-115, n=8), weekly exenatide injections (Bydureon BCise®, n=8), or weekly 1 mg semaglutide injections (Wegovy®, n=8) for a 9-week treatment duration. Changes in weight will be measured. The study is currently on-going at two study centers in Australia and is fully enrolled. Top-line data from the study is anticipated to be available in mid-2025.

If available, Vivani intends to utilize research and development incentives and rebates from the Australian government to defray a portion of the costs from this clinical trial. Since clinical studies conducted in Australia comply with the International Conference on Harmonization guidelines, data generated in Australia generally are acceptable to the U.S. Food and Drug Administration and other regulatory authorities. Vivani anticipates use of relevant clinical data generated in Australia to support regulatory submissions in other geographies including the United States. Additional guidance regarding future regulatory submissions will be provided as new information becomes available.

About Vivani Medical, Inc.

Leveraging its proprietary NanoPortal^TM platform, Vivani develops biopharmaceutical implants designed to deliver drug molecules steadily over extended periods of time with the goal of guaranteeing adherence, and potentially to improve patient tolerance to their medication. Vivani’s lead program, NPM-115, is a six-month, subdermal, GLP-1 (exenatide) implant under development for chronic weight management in obese or overweight individuals. Vivani’s emerging pipeline includes NPM-139 (semaglutide implant) which is also under development for chronic weight management in obese and overweight individuals. The semaglutide implant has the added potential benefit of once-yearly administration. NPM-119 refers to the Company’s six-month, subdermal, GLP-1 (exenatide) implant under development for the treatment of type 2 diabetes. These NanoPortal 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 treatments, face significant challenges in achieving positive real-world effectiveness. While the current GLP-1 landscape includes over 50 new molecular entities under clinical stage development, Vivani remains confident that its highly differentiated portfolio of miniature long-acting GLP-1 implants have the potential to provide an attractive therapeutic option for patients, prescribers and payers. For more information, please visit www.vivani.com.

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 Vivani’s business, products in development, including the therapeutic potential thereof, the planned development therefor, the completion of the LIBERATE-1 trial and reporting of trial results, Vivani’s emerging development plans for NPM-115, NPM-139, NPM-119, or Vivani’s plans with respect to Cortigent and its 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 Vivani’s 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 Vivani’s 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 Vivani’s products, including NPM-115, NPM-139, and NPM-119; delays and changes in the development of Vivani’s products, including as a result of applicable laws, regulations and guidelines, potential delays in submitting and receiving regulatory clearance or approval to conduct Vivani’s development activities; risks related to the initiation, enrollment and conduct of Vivani’s planned clinical trials and the results therefrom; Vivani’s history of losses and Vivani’s ability to access additional capital or otherwise fund Vivani’s business; market conditions and the ability of Cortigent to complete its intended spin-off from the Company. 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 U.S. Securities and Exchange Commission filed on March 26, 2024, as updated by the Company’s subsequent Quarterly Reports on Form 10-Q. Any forward-looking statement made by Vivani 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250313070479/en/

Company:

Donald Dwyer

Chief Business Officer

info@vivani.com

(415) 506-8462

Investor Relations:

Jami Taylor

Investor Relations Advisor

investors@vivani.com

(415) 506-8462

Media:

Sean Leous

ICR Healthcare

Sean.Leous@ICRHealthcare.com

(646) 866-4012

Source: Vivani Medical, Inc.

FAQ

What are the key features of Vivani Medical's NPM-115 GLP-1 implant for weight management?

NPM-115 is a miniature, twice-yearly GLP-1 (exenatide) implant that showed comparable preclinical weight loss to semaglutide. It's designed to improve medication adherence through reduced dosing frequency compared to daily oral and weekly injectable alternatives.

How many participants are enrolled in VANI's LIBERATE-1 clinical trial for NPM-115?

The LIBERATE-1 trial achieved full enrollment with 24 subjects within four weeks of the first subject's enrollment.

When will Vivani Medical (VANI) release the top-line results for the NPM-115 implant trial?

Vivani Medical expects to release top-line results from the LIBERATE-1 trial in mid-2025.

What potential advantages does VANI's NPM-115 implant offer over current GLP-1 medications?

NPM-115 offers twice-yearly dosing versus daily/weekly alternatives, potentially improving medication adherence and reducing tolerability issues associated with missed doses of current GLP-1 medications.

How did the first NPM-115 implant procedure perform in VANI's clinical trial?

The first NPM-115 implant administration was reported as successful and well-tolerated by the subject.