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Nasdaq: VANI Guaranteed Adherence. Better Outcomes. www.vivani.com Vivani Medical, Inc.
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Nasdaq: VANI 2 Disclaimers The following slides and any accompanying oral presentation contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be covered by the "safe harbor" created by those sections. All statements in this release that are not based on historical fact are "forward looking statements." These statements may be identified by words such as "estimates," "anticipates," "projects," "plans" or "planned," "strategy," “goal," "seeks," "may," "will," "expects," "intends," "believes," "should," and similar expressions, or the negative versions thereof, and which also may be identified by their context. All statements that address operating performance or events or developments that Vivani Medical, Inc. ("Vivani", the "Company", "we" or "us”) expects or anticipates will occur in the future, such as stated objectives or goals, our products and their therapeutic potential and planned development, the indications that we intend to target, our technology, our business and strategy, milestones, addressable markets, or that are not otherwise historical facts, are forward-looking statements. While management has based any forward-looking statements included in this presentation on its current expectations, the information on which such expectations were based may change. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements as a result of various factors. These risks and uncertainties include, but are not limited to, that we may fail to commence our planned future clinical trials for products under development; conduct any pre-clinical activities of our other products; our products may not demonstrate safety or efficacy in clinical trials; we may fail to secure marketing approvals for our products; there may be delays in regulatory approval or changes in regulatory framework that are out of our control; our estimation of addressable markets of our products may be inaccurate; we may fail to timely raise additional required funding; more efficient competitors or more effective competing treatment may emerge; we may be involved in disputes surrounding the use of our intellectual property crucial to our success; we may not be able to attract and retain key employees and qualified personnel; earlier study results may not be predictive of later stage study outcomes; and we are dependent on third-parties for some or all aspects of our product manufacturing, research and preclinical and clinical testing. Additional risks and uncertainties are described in our Annual Report on Form 10-K filed on March 31, 2025, and our subsequent filings with the U.S. Securities and Exchange Commission. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto, or any change in events, conditions, or circumstances on which any such statement is based. Certain information contained in this presentation relates to or is based on studies, publications, surveys and other data obtained from third party sources and the Company’s own internal estimates and research. While we believe these third-party sources to be reliable as of the date of this presentation, we have not independently verified, and make no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. Finally, while we believe our own internal research is reliable, such research has not been verified by any independent source. All of our therapies are still investigational and have not been approved by any regulatory authority for any use.
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Nasdaq: VANI 3 The obesity market is evolving What will it take to be successful in the future? In addition to the approved products on the market, there are over 50 in clinical development. All of these are injectables or orals. A differentiated route of administration presents opportunities to access untapped segments of this market, transition experienced patients to a longer-acting option, and help patients struggling with adherence to have access to a guaranteed-adherence option. Implants uniquely offer both longer duration and reversibility. 3 FDA-approved GLP-1 injectables 1 FDA-approved GLP-1 orals >50 Clinical-stage injectables or orals for obesity 1 Clinical-stage subdermal implant
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Nasdaq: VANI 4 Vivani’s differentiated product candidates are designed to address unmet needs and expand the market Market Challenges Suboptimal outcomes Poor medication adherence (<50%) leads to loss of efficacy and rapid weight rebound Tolerability issues Dose fluctuations and pharmacokinetic (PK) variability provoke side effects The NanoPortal Promise Convenient, guaranteed adherence Maintains therapeutic effect and delivers medical and pharmacoeconomic outcomes Stable delivery Expected to reduce side effects associated with fluctuating drug plasma levels Pricing & access challenges 13+ devices/year drive higher cost of goods, reducing pricing flexibility with subcutaneous (SC) dosing 1-2 devices/year results in lower cost of goods vs. SC dosing, providing greater pricing flexibility Lower costs and pricing flexibility Differentiated modality Infrequent, in-office administration by primary care professionals reaches underserved populations Underserved & unaddressed populations Current options not ideal for hard-to-reach, difficult-to- manage, discretion- or convenience-seeking patients
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Nasdaq: VANI 5 Vivani Medical, Inc. A clinical stage innovator uniquely positioned to address the future challenges and opportunities of an evolving obesity market Nasdaq: VANI Cash runway through key milestones and into 2027 NPM-139 clinical program initiation in 1H 2026 Manufacturing & operations in Alameda, CA GLP-1 Market expected to grow to $139B by 2030* Our focus: Enhance patient outcomes and GLP-1 market uptake in chronic diseases via unique route of administration, improved patient adherence, tolerability, and convenience Technology: NanoPortal ultra long-acting, miniature drug implants designed to enable dosing every 6 to 12 months Lead program: NPM-139 is a miniature, subdermal, semaglutide implant for chronic weight management in obese and overweight individuals Clinical success: LIBERATE-1 first-in-human study achieved the primary objectives including positive safety, tolerability and device performance Platform Proof of Concept: Preclinical weight loss of ~20% sustained at 7 months in an ongoing study *TD Cowen (M. Nedelcovych, S. Scala, C. Rhyee, Y. Werber, E. McAllister), “GLP-1 Market: The Pipeline Expands.” March 2025.
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Nasdaq: VANI 6 Company pipeline utilizing NanoPortal platform If approved, Vivani products may compete in markets with large commercial potential Indication Feasibility Pre-Clinical Clinical Market Size** Partnered Vivani Obesity/Weight Management >$60B NPM-139* semaglutide Obesity/Weight Management >$60B NPM-115 exenatide Type 2 Diabetes >$60B NPM-133 semaglutide *Feasibility recently established with semaglutide, supporting priority development. **Estimated Market Sizes where Vivani products would compete, if approved. Does not represent future sales or revenue estimates of Vivani pipeline products. TD Cowen estimates $139B in GLP-1 sales by 2030. We assume >$60B for Obesity/Chronic Weight Management and >$60B for Type 2 Diabetes by 2030. *** In Partnership with Okava Pharmaceuticals, Inc. Market size estimate based on Okava internal analysis. Canine & Feline Obesity >$2B OKV-119*** exenatide
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Nasdaq: VANI 7 Good things come in small packages ✓ Simple administration, in-office procedure to insert the implant comfortably under the skin for twice- yearly dosing designed to produce Wegovy®-level efficacy ✓ Designed to assure adherence ✓ Long-term delivery ✓ Stable and tunable release profile 01GLP-1 implant & applicator 02NanoPortal device elements 03NanoPortal technology ✓ Nanotube pore size is precisely tunable to achieve near-constant release profiles Reservoir Medication Nanotubes No release Pore too small Constant release rate Target pore size Rapid release Pore too large
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Nasdaq: VANI 8 NanoPortal delivers smooth, near-constant drug release *Release-rates include exenatide and related substances. In vitro release-rate of exenatide implant (n=6). Day 1 timepoint includes cumulative release over the first day including a separately measured 1st hour of release, which was ~7 µg for the high-dose and ~4 µg for the low-dose. Values are mean ± SD.
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Nasdaq: VANI 9 In vitro and in vivo performance of 12-week GLP-1 implant configuration In vivo pharmacokinetics of 12-week exenatide implant and sham implant in high fat diet-induced obese mice (n=7 per group). Values are mean ± SE. Day 56 values reported as measured, but sample handling error suspected to have occurred. In vitro release-rate of exenatide implant (n=17). Individual values are included for each timepoint. Each week consists of two 24-hour intervals and a 5-day interval. Values are mean ± 1 SD (bold) and ± 2 SD. Release-rates include exenatide and related substances.
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Nasdaq: VANI 10 GLP-1 NanoPortal implant reduced liver fat by 82% in preclinical study Liver fat reduction in high fat diet-induced obese mice. Liver fat % area for exenatide implant vs sham implant 12 weeks after a single administration. Values are mean ± SE. Sham Implant (n=7) Exenatide Implant (n=7) 0.0 5.0 10.0 15.0 20.0 25.0 30.0 35.0 Liver fat (% Area)
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Nasdaq: VANI 11 Preclinical GLP-1 NanoPortal implant is associated with durable body weight effects * A B Weight difference from control in healthy Sprague-Dawley Rats. % weight change from baseline for a single administration of exenatide implant in a study associated with NPM-119 (~320 nmol/kg/day) corrected to control (vehicle implant). (A) All animals measured through 105 days of treatment; (B) 5 animals measured in each group through 112 days of treatment followed by a 28-day recovery period. Values are mean ± SE.
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Nasdaq: VANI 12 First-in-human GLP-1 NanoPortal clinical trial: LIBERATE-1 Primary Objectives Safety/tolerability assessment and full pharmacokinetic characterization. Key Inclusion/Exclusion Criteria 18-55 years old; overweight or obese (BMI 27-40) Otherwise healthy (no T2D, normal renal function) T2D = Type 2 Diabetes; EOT = End of Treatment; EOS = End of Study
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Nasdaq: VANI 13 Primary study objectives were met: Implant safety, tolerability, and PK No clinically meaningful initial burst No evidence of dose dumping Implant well-tolerated No serious adverse events in the study Encouraging release profile Potential for durable long-term delivery confirmed Further NanoPortal clinical development supported LIBERATE-1 topline results summary
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Nasdaq: VANI Vivani Lead Program: NPM-139 Semaglutide Implant for Chronic Weight Management Targeting the Rapidly Growing GLP-1 Market
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Nasdaq: VANI 15 15 Priority clinical development program: NPM-139 Development of once- or twice-yearly semaglutide implant for chronic weight management in obese or overweight patients GLP-1 products generated >$14B in sales in 2024 for chronic weight management. The obesity market is expected to grow at ~32% CAGR.1 Based on real-world adherence and persistence data, >50% of patients regularly miss doses; >50% discontinue by year 1 and ~75% discontinue by year 22 The initial program activities are being designed to support additional semaglutide applications such as type 2 diabetes (NPM-133), CKD in type 2 diabetes, MASH, alcohol addiction, etc. 1 Grand View Research. (2023, November). GLP-1 agonists weight loss drugs market size, share & trends analysis by drugs (Semaglutide (Wegovy), Tirzepatide (Zepbound)), by route of administration, by distribution channel, by region, and segment forecasts, 2025 - 2030. Grand View Research. https://www.grandviewresearch.com/industry-analysis/glp-1-agonists-weight-loss-drugs-market-report 2 Gleason, P. P., Urick, B. Y., Marshall, L. Z., Friedlander, N., Qiu, Y., & Leslie, R. S. (2024). Real-world persistence and adherence to glucagon-like peptide-1 receptor agonists among obese commercially insured adults without diabetes. Journal of managed care & specialty pharmacy, 30(8), 860–867. https://doi.org/10.18553/jmcp.2024.23332
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Nasdaq: VANI 16 Persistence and adherence are critical to securing desired long-term health outcomes Persistence data comparing obesity therapies suggest room for improvement across the board, including for semaglutide. Large Retrospective Cohort Study* (N=1,911) 100% 75% 50% 25% 0% Percent Remaining on Therapy ** Implant not included in this Large Retrospective Cohort Study, included for illustrative purposes only; assumes full replacement at 6 months 6 months 12 months * Published in Obesity, December 8, 2023 The opportunity for an additional 60% improvement in persistence for semaglutide is significant and could translate to improved patient outcomes Semaglutide implant is designed to guarantee adherence during the entire once- or twice-yearly dosing interval
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Nasdaq: VANI 17 Semaglutide discontinuation leads to rapid hunger- induced weight rebound STEP 1 Extension: Semaglutide Withdrawal Wilding et al., 2022, Diabetes, Obesity, and Metabolism Wilding et al., 2022, Diabetes, Obesity, and Metabolism
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Nasdaq: VANI 18 Semaglutide implant successfully delivers durable weight loss in preclinical model for >7 months Weight difference versus control group in healthy Sprague-Dawley rats. % weight change from baseline for NPM-139 (semaglutide implant) corrected to control (sham implant). Implants from 4 animals were removed on each of Day 21, Day 84, and Day 168 for characterization. Values are mean ± SE.
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Nasdaq: VANI 19 Patient and prescriber research indicates strong adoption potential for a miniature, 6-month GLP-1 implant 11% 33% 42% 14% Currently on a GLP-1 therapy (n=324) 17% 36% 35% 12% Ex-GLP-1 therapy (n=178) 17% 39% 34% 10% GLP-1 therapy naïve (n=319) Definitely not Unlikely Likely Definitely 56% of GLP-1 patients responded “likely” or “definitely” to get a GLP-1 implant if FDA approved, prescriber recommended, and covered by insurance dQ&A Insights reported market research during FDA Advisory Board to review ITCA 650 (exenatide implant) on September 21, 2023. Research conducted in patients with T2D Average prescriber rating of 8.3 on a 10- point scale regarding likelihood of prescribing a long-acting GLP-1 implant Vivani sponsored qualitative (n=10) market research of diabetes treating primary care physicians, March 2020. ~90% of patients receive treatment in primary care Nexplanon demonstrates commercial potential for a subdermal implant in primary care (~$1B in annual sales)
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Nasdaq: VANI 20 NPM-139 clinical and regulatory development: Near-term plan builds on recent wins Milestone Status Announced LIBERATE-1 completed and met the primary study objectives August 2025 Reported positive weight loss in preclinical study with semaglutide implant August 2025 Disclosed proposed clinical program including Phase 1 PK and Phase 2 dose-ranging weight maintenance studies September 2025 Initiate NPM-139 clinical program 1H 2026 (projected)
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Nasdaq: VANI 21 Proposed NPM-139 Phase 1 study design Primary Objectives Safety/tolerability assessment and full pharmacokinetic characterization. Key Inclusion/Exclusion Criteria 18-55 years old; overweight or obese (BMI 27-40) Otherwise healthy (no T2D, normal renal function). NPM-139 (semaglutide implant, ~0.25 mg/week, n=8-10) Wegovy® (semaglutide injection, 0.25 mg/week, n=8-10) Screen and Randomize (~14 days) EOT 1Week 2 Treatment (4 Weeks) 3 4 T2D = Type 2 Diabetes; EOT = End of Treatment 5 Primary Objectives Safety/tolerability assessment and pharmacokinetic characterization Key Inclusion/Exclusion Criteria 18-55 years old; overweight or obese (BMI 27-40) Otherwise healthy (no T2D)
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Nasdaq: VANI 22 Proposed NPM-139 Phase 2 study design Semaglutide Implant Dose 3 Semaglutide Implant Dose 1 Placebo (sham implant) Semaglutide 0.25 mg 0.5 mg 1.0 mg 1.7 mg 2.4 mg Semaglutide Implant Dose 2 Run-In (20 weeks) Randomized Treatment Period (16 or 24 weeks) Dose escalation at 4-week intervals Randomize Wegovy® (semaglutide injection, 2.4 mg/week)* *unblinded
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Nasdaq: VANI 23 The Vivani executive leadership team Adam Mendelsohn PhD CEO/Director ✓ Co-founder/Co-inventor of Vivani technology ✓ PhD Bioengineering (UCSF/UC Berkeley) ✓ Management of Technology Certificate at Haas School of Business ✓ Research focused on diabetes treatment ✓ Formerly at Boston Scientific and MiniMed Donald Dwyer, MBA Chief Business Officer ✓ Former Executive Director at AstraZeneca with leadership roles in regulatory affairs, drug development, commercial and business development ✓ Former Vivani Board observer for AZ ✓ Former PhaseBio Board observer for AZ (prior to IPO) ✓ Former Director at Cephalon and Rhone Poulenc Rorer Truc Le, MBA Chief Operations Officer ✓ Numerous COO and Executive Positions at Device and Drug-Device Companies, including: ✓ CTO at Dance BioPharm, COO at Avid Bio ✓ Exec VP at Prima Biomed, Sr. VP at Nektar Therapeutics (responsible for Exubera approval), and Worldwide VP at Johnson & Johnson Lisa Porter, MD Chief Medical Officer ✓ Former Chief Medical Officer for Eiger BioPharmaceuticals and Dance BioPharm ✓ Former VP of Medical Development for Amylin ✓ Former Director at GSK, Global Head of Clinical Strategy for Avandia ✓ Former Board member of ViaCyte, Inc. Anthony Baldor, MS, MBA Chief Financial Officer ✓ Former CFO and Head of Business Development at Diakonos Oncology ✓ Former VP Corporate Strategy and Development at 4DMT ✓ Former Research Analyst at Jefferies ✓ Former Venture Capital Principal at BioInnovation Capital and Associate at RMI Partners
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Nasdaq: VANI 24 Vivani headquarters and GMP manufacturing facility
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Nasdaq: VANI 25 Guaranteed adherence. Improved outcomes. Only GLP-1 implant in development Unique modality designed to expand the market by reaching underserved & unaddressed populations Convenient once- or twice-yearly dosing expected to address GLP-1 adherence and tolerability challenges
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Nasdaq: VANI www.vivani.com Thank You Company Contact: Donald Dwyer, Chief Business Officer info@vivani.com Investor Relations Contact: Jami Taylor, Investor Relations Advisor investors@vivani.com