Vivani Medical, Inc. · NASDAQ:VANI
Vivani Medical — Investor Presentation (March 2025)
36 slides from Vivani Medical's investor presentation, Mar 31, 2025
Slide 1: Vivani Medical March 2025
Nasdaq: VANI www.vivani.com March 2025
Slide 2: Disclaimers
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 ha
Slide 3: Vivani Executive Leadership Team
Vivani Executive Leadership Team • 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 Adam Mendelsohn PhD – CEO/Dire
Slide 4: Vivani Medical, Inc.
Vivani Medical, Inc. 4 Lead programs include NPM-115 (high-dose exenatide) and NPM-139 (semaglutide). These miniature, subdermal, GLP-1 implants are under development for chronic weight management in obese and overweight individuals with once or twice-yearly dosing. Pipeline also includes IND-cleare
Slide 5: Company Pipeline
Company Pipeline If Approved, Vivani Products will Compete in Markets with Large Potential Indication Feasibility Pre-Clinical Clinical Market Size* Human Type 2 Diabetes Human Obesity NPM-119 exenatide >$60B NPM-139 >$60B Vivani * Estimated Market Sizes where Vivani products would compete, if appro
Slide 6: Drug Implants Proprietary Platform Technology
Drug Implants Proprietary Platform Technology
Slide 7: GLP-1 (exenatide) Implant and Applicator
GLP-1 (exenatide) Implant and Applicator 7 Approximate size of implant expected for type 2 diabetes indication
Slide 8: Designed to assure adherence
Designed to assure adherence Minimally-fluctuating and tunable delivery profiles Potential application with many molecular types
Slide 9: NanoPortal How it Works
NanoPortalTM How it Works...By precisely adjusting the nanotube pore size to slightly greater than the size of specific drug molecules, the interactions between the drug and nanotube walls can result in desirable release profiles over time, including near constant release
Slide 10: NanoPortal delivers near-constant / minimally-fluctuating drug release
NanoPortal delivers near-constant / minimallyfluctuating drug release 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. Fluctuations during each 2.5-h
Slide 11: NanoPortal is a Platform Technology
NanoPortalTM is a Platform Technology Broad Potential Application Can Support Portfolio of New Drug Implants Minimized Implant Size Extendable Implant Duration Tunable Delivery Rate Tunable Delivery Profile
Slide 12: NanoPortal implant technology designed to avoid earlier device challenges
(Intarcia) • FDA alleges that daily variations in drug release may be responsible for clinical safety signals which prevented regulatory approval • Larger Device (4mm x 45mm) • Insertion using larger 6-gauge needle • Minimally fluctuating drug release profile observed in pre-clinical studies directl
Slide 13: NanoPortal addresses key ITCA-650 release-rate variability issue
NanoPortal addresses key ITCA-650 release-rate variability issue flagged by FDA as root cause of non-approvability (Intarcia) Osmotic Pump, ITCA 650 NanoPortalTM (Vivani) 13 “The clinical data in the three pivotal clinical trials for ITCA 650 including the high rates of GI side effects, discontinuat
Slide 14: Vivani Lead Program NPM-115 High-Dose Exenatide Implant
Vivani Lead Program NPM-115 High-Dose Exenatide Implant for Chronic Weight Management Targeting the Rapidly Growing GLP-1 RA Market
Slide 15: Priority Program NPM-115: 6-Month Exenatide Implant for Chronic Weight Management
Priority Program NPM-115: Development of 6-Month Exenatide (Glucagon-like Peptide 1 Receptor Agonist) Implant for Chronic Weight Management in Obese or Overweight Patients • Tremendous unmet medical need in Obesity1 : • 764M people living with obesity • 15M (2%) taking an anti-obesity medication • G
Slide 16: Weight Loss Medicines Associated With Adherence Challenges
Weight Loss Medicines Associated With Adherence Challenges Recent retrospective cohort study (n=1,911) reported improved medication persistence with semaglutide of 40% after one year The remaining opportunity for an additional 60% improvement in persistence is significant and will translate to impro
Slide 17: GLP-1 Discontinuation Can Lead to Rapid Hunger-Induced Weight Rebound
GLP-1 Discontinuation Can Lead to Rapid HungerInduced Weight Rebound in Animals and Huma Sudden GLP-1 withdrawal produces immediate rebound hunger, leading to rapid weight regain mediated by greater food consumption
Slide 18: Exenatide implant associated with comparable weight loss to semaglutide
Exenatide implant associated with comparable weight loss to semaglutide in preclinical study 18 Weight loss in high fat diet-induced obese mice. (A) % weight change from baseline for a single administration of exenatide implant (~530 nmol/kg/day) vs weekly Ozempic injections (semaglutide, 2,700 nmol
Slide 19: Exenatide implant reduces liver fat by 82% in obese mice
Exenatide implant reduces liver fat by 82% in obese mice after 12 weeks 19 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. Liver fat % area is calculated using Oil Red O (ORO) staining. Values are
Slide 20: Exenatide with NanoPortal is associated with durable body weight effects
Exenatide delivered with NanoPortal technology is associated with durable body weight effects 20 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) correct
Slide 21: In vivo and in vitro performance of 12-week implant for LIBERATE-1
In vivo and in vitro performance of 12-week exenatide implant configuration to be studied in LIBERATE-1 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 ha
Slide 22: 6-Month exenatide implant preclinical proof-of-concept achieved
6-Month exenatide implant preclinical proof-of-concept achieved Implants removed * 22 Pharmacokinetics of 6-month exenatide implant in male Sprague-Dawley rats (n=6) Exenatide antibody-positive animals are not included in this data set. Values are mean ± SD. *2 of 6 implants are responsible for high
Slide 23: Proposed First-in-Human Trial: LIBERATE-1
Proposed First-in-Human Trial: LIBERATE-1 Primary Objectives: NPM-119 (N=8) 23 Safety/tolerability assessment and full pharmacokinetic characterization. Changes in weight will also be assessed. Key Inclusion/Exclusion Criteria: 18-55 years old; overweight or obese (BMI 27-40) Otherwise healthy (no T
Slide 24: NPM-115 Clinical + Regulatory Development Near-Term Plan
NPM-115 Clinical + Regulatory Development Near-Term Plan November 2023 – Vivani announced NPM-115 clinical program (high-dose exenatide implant) for chronic weight management. February 2024 – Company reported positive preclinical study results demonstrating comparable weight loss between exenatide i
Slide 25: NPM-119 Exenatide Implant for Type 2 Diabetes
NPM-119 Exenatide Implant for Type 2 Diabetes
Slide 26: Significant unmet need in Diabetes
Significant unmet need in Diabetes1 : • 537M people living with diabetes • ~ 15% in good control • Non-adherence is the primary reason for low, real-world effectiveness2,3 • Guaranteed adherence will produce significant healthcare cost savings4 • FDA indicated 505(b)(2) streamlined approval pathway
Slide 27: Current Drug Adherence Challenge
Current Drug Adherence Challenge "Drugs don't work in people that don't take them NPM-119* Designed to Enable 100% Adherence through Implant Duration Dual Incentive to Adopt Technology that Improves Adherence • Pharmaceutical revenue is increased • Healthcare costs are decreased Current Drug Adheren
Slide 28: Patient research indicates strong adoption potential
Patient research indicates strong adoption potential for a miniature, 6-month exenatide implant dQ&A insights reported market research during FDA Advisory Board to review ITCA 650 (exenatide implant) on September 21, 2023 28 56% of patients responded “likely” or “definitely” to get an exenatide impl
Slide 29: Prescriber and Payer research support a miniature 6-month exenatide implant
Prescriber and Payer research also provide strong support for a miniature, 6-month exenatide implant Rating: Overall, using a scale of 1 to 10, where 1 is not at all likely and 10 is extremely likely, how likely are you to prescribe NPM-119? Vivani sponsored qualitative market research, March 2020.
Slide 30: Once or twice-yearly Semaglutide Implant for Chronic Weight Management
Development of once or twice-yearly Semaglutide (Glucagon-like Peptide 1 Receptor Agonist) Implant for Chronic Weight Management in Obese or Overweight Patients Semaglutide products Ozempic® and Wegovy® generated ~$25B in sales in 2024 • More than half of patients regularly miss doses based on real-
Slide 31: Semaglutide implant preclinical proof-of-concept achieved
Semaglutide implant preclinical proof-of-concept achieved in ongoing study 31 Body weight measurements of semaglutide implant in male Sprague-Dawley rats (n=8) Weight difference versus control group in healthy Sprague-Dawley Rats. % weight change from baseline for NPM-139 (semaglutide implant) corre
Slide 32: Vivani Medical, Inc. Financial Information
Vivani Medical, Inc. Financial Information
Slide 33: Q4 2024: Income/(Loss) Statement
Vivani Medical, Inc. Q4 2024: Income/(Loss) Statement
Slide 34: Q4 2024: Balance Sheet
Vivani Medical, Inc. Q4 2024: Balance Sheet
Slide 35: Q4 2024: Cap Table
Vivani Medical, Inc. Q4 2024: Cap Table 35 As of December 31, 2024 Equity WAEP* Number of Shares Common Stock 59,234,688 Stock Options $2.52 6,809,230 RSUs - 695,000 Warrants $3.42 9,340,442 Fully Diluted Shares 76,079, 360 *Weighted Average Exercise Pric
Slide 36: Vivani Medical, Inc.
Vivani Medical, Inc. 36 Lead programs include NPM-115 (high-dose exenatide) and NPM-139 (semaglutide). These miniature, subdermal, GLP-1 implants are under development for chronic weight management in obese and overweight individuals with once or twice-yearly dosing. Pipeline also includes IND-clear