Vivani Medical, Inc. · NASDAQ:VANI
Vivani Medical — Q3 2023 Earnings Presentation
33 slides from Vivani Medical's earnings presentation, Nov 14, 2023
Slide 1: Vivani Medical, Inc. Guaranteed Adherence. Better Outcomes.
Vivani Medical, Inc. Guaranteed Adherence. Better Outcomes. Nasdaq: VANI November 14, 2023 www.vivani.com
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 "s afe
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/
Slide 4: Vivani Medical, Inc. overview
Vivani Medical, Inc. Lead programs NPM - 119 and NPM - 115 are miniature, six - month, GLP - 1 implants under development for the treatment of type 2 diabetes and chronic weight management in obese or overweight patients, respectively. Vivani’s pipeline also contains NPM - 139, using an undisclosed
Slide 5: Company Pipeline
Feline Pre - Diabetes & Diabetes >$500M Human Obesity >$50B 5 Company Pipeline If Approved, Vivani Products will Compete in Markets with Large Potential Indication Feasibility Pre - Clinical Clinical Market Size* Human Type II Diabetes Human Obesity NPM - 119 exenatide >$20B >$50B NPM - 139** Vivani
Slide 6: Drug Implants Proprietary Platform Technology
Drug Implants Proprietary Platform Technology
Slide 7: NanoPortal: Innovative Delivery Technology
Potential application with many molecular types Designed to Assure Adherence Minimally - fluctuating and tunable delivery profiles NanoPortal: Innovative Delivery Technology Drug Reservoir Nanotube Membrane 7
Slide 8: NanoPortal: How it Works
By precisely adjusting nanotubes to molecule size, interactions between drug and nanotube walls can result in desirable release profiles over time, including near constant release NanoPortal : How it Works... Pore too small: No release Pore target size: Near constant release Pore too large: Burst re
Slide 9: In Vitro Release Rate: near-constant, minimally fluctuating release
0 20 40 60 80 100 120 98.0 98.5 99.0 99.5 100.0 In Vitro Release - Rate (ug/Day)* Time (days) Minimal Fluctuations with 2.5 - hour interval sampling Near - constant and minimally - fluctuating release *Release - rates include exenatide and related substances. Day 1 timepoint includes cumulative rele
Slide 10: NanoPortal is a Platform Technology
Minimized Implant Size Extendable Implant Duration Tunable Delivery Rate Tunable Delivery Profile NanoPortal TM is a Platform Technology Broad Potential Application Can Support Portfolio of New Drug Implants 10
Slide 11: Targeting the Rapidly Growing GLP-1RA Market: Lead Program NPM-119
Targeting the Rapidly Growing GLP - 1 RA Market Vivani’s Lead Program NPM - 119
Slide 12: Lead Product NPM-119: 6-Month Exenatide Implant for Type 2 Diabetes
1 Guo 2016 2 Carls et al., 2017 3 IMS 2013 Report • Non - adherence is the primary reason for low, real - world effectiveness 1,2 • Guaranteed adherence will produce significant healthcare cost savings 3 • FDA indicated 505(b)(2) streamlined approval pathway may be available • ~$54M raised pre - mer
Slide 13: NPM-119 Implant and Applicator
NPM - 119 Implant and Applicator 13
Slide 14: The GLP-1 Market is very large and growing rapidly
2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 40 20 15 10 5 0 Expected 2028 ~$37B The GLP - 1 Market is very large and growing rapidly World - wide Sales ($Billions)* • Adopted from Evaluate Pharma • JP Morgan a nalyst Richard Vosser estimates GLP - 1 Market to reach $71 bill
Slide 15: NPM-119 Designed to Enable 100% Adherence through Implant Duration
Ozempic Januvia Invokana NPM - 119* 100% 75% 50% 25% 0% GLP - 1 agonist, weekly injection Mody et al., 2022 DPP - 4 inhibitors, daily pills Polonsky et al.,2016 SGLT - 2 daily pills Cai et al., 2017 GLP - 1 implant every 6 months • Orals and injectables do not guarantee adherence • Approximately 50%
Slide 16: Intarcia's ITCA 650 as a value analog for NPM-119
Intarcia’s 1 ITCA 650 (6 - month exenatide implant) may be a relevant value analog for NPM - 119 2014 – Intarcia signed ITCA 650 deal with Servier (excluding US + Japan) $171M up - front, $880M milestones, and double - digit royalties – Financings valued Intarcia as high as $4.0B (2017); Intarcia’s
Slide 17: NPM-119 well-positioned to avoid ITCA 650's device challenges
(Intarcia) • FDA alleges that daily variations in drug release may be responsible for clinical safety signals • Larger Device (4mm x 45mm) • Insertion using larger 6 - gauge needle • Minimally fluctuating drug release profile observed in pre - clinical studies • Smaller Device (2.2mm x 21.5mm) • Ins
Slide 18: ITCA 650 and NPM-119 Intra-Device Daily In Vitro Release Fluctuation Comparison
ITCA - 650 and NPM - 119 Intra Device Daily In Vitro Release Fluctuation Comparison Data presented by FDA on September 21, 2023, ITCA 650 Advisory Board Hearing (first 6 of 12 devices) NanoPortal TM (NPM - 119, N=6) Osmotic Pump (ITCA 650, through Day 100) 0 25 50 75 100 0 20 40 5 0 20 40 4 3 1 6 2
Slide 19: Patient market research indicates strong adoption potential
19 Patient market research indicates strong market 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 19 Never taken a GLP - 1 RA 56% of patients responded “like
Slide 20: Prescriber and Payer research support a 6-month exenatide implant
0 2 4 6 8 10 Likely to Prescribe (1=not likely, 10=extremely likely) Primary Care Physicians (n=10) Prescribing Rating, Average 8.3 out of 10 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
Slide 21: 6-Month NPM-119 preclinical proof-of-concept achieved
0 100 200 300 400 500 600 700 0 2 4 6 8 10 12 14 16 0 30 60 90 120 150 Expected Exenatide Plasma Concentration in 85 kg Human ( pg /mL) Exenatide Plasma Concentration Normalized to 250g Rats (ng/mL) Time from initial initiation (days) 6-Month NPM-119 Prototype (n=6) 6 - Month NPM - 119 preclinical p
Slide 22: NPM-119 Clinical and Regulatory Pathway
NPM - 119 Clinical and Regulatory Pathway
Slide 23: Proposed First-in-Human Trial: LIBERATE-1
Proposed First - in - Human Trial: LIBERATE - 1* Primary Objectives: Safety/tolerability assessment and full PK characterization Secondary Objective: Evaluate change from baseline in glycemic control (HbA1c) Randomize 12 Weeks Key Inclusion/Exclusion Criteria • T2DM and HbA1c ≥6.5% and <9.5% • On no
Slide 24: NPM-119 Clinical and Regulatory Development Near-Term Plan
NPM - 119 Clinical + Regulatory Development Near - Term Plan Year(s) Milestone Status 2023 IND filed to support First - in - Human (LIBERATE - 1) clinical study July 14, 2023 2023 FDA provided Clinical Hold letter August 18, 2023 2023 Type A face - to - face meeting with FDA October 19, 2023 August
Slide 25: 12-Week NPM-119 PK in Rats
0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1 1.1 0 5 10 15 20 25 0 30 60 90 120 Expected Exenatide Plasma Concentration in 85 kg Human (ng/mL) Exenatide Plasma Concentration Normalized to 250g Rats (ng/mL) Time from initial initiation (days) 12 - Week NPM - 119 PK in Rats (n=8) * Exenatide antibody - pos
Slide 26: NPM-115: 6-Month Exenatide Implant for Chronic Weight Management
• Tremendous unmet medical need in Obesity 1 : • 764M people living with obesity • 15M (2%) taking an anti - obesity medication • GLP - 1 monotherapy may provide adequate weight loss for the majority of patients 2 • Preliminary pre - clinical data demonstrated similar magnitude of weight loss for ex
Slide 27: Exenatide comparable weight loss to semaglutide in preclinical studies
Exenatide is associated with comparable weight loss to semaglutide in preclinical studies Exenatide caused ~23% weight loss after 3 weeks in diet - induced obese mice when delivered at 30 nmol/kg/day 1 Semaglutide caused ~23% weight loss after 3 weeks in diet - induced obese mice when delivered at 3
Slide 28: GLP-1 monotherapy provides adequate weight loss for most obese patients
GLP - 1 monotherapy provides adequate weight loss for most obese patients GLP - 1 monotherapy is capable of enabling ~64% of obese population to become non - obese BMI=30 (Obese) BMI=35 ~64% of all obese individuals 28
Slide 29: Vivani Medical, Inc. Financial Information
Vivani Medical, Inc. Financial Information
Slide 30: Q3 2023: P&L Statement
Vivani Medical, Inc. Q3 2023: P&L Statement 30 In Thousands, except per Share Data Sep. 30, 2023 Sep. 30, 2022 Sep. 30, 2023 Sep. 30, 2023 Operating expenses: Research and development, net of grants 4,441$ 3,859$ 12,260$ 9,742$ General and administrative 2,703 1,585 8,488 3,709 Total operating expen
Slide 31: Q3 2023: Balance Sheet
Vivani Medical, Inc. Vivani Medical, Inc. Q3 2023: Balance Sheet 31
Slide 32: Q3 2023: Cap Table
Vivani Medical, Inc. Q3 2023: Cap Table 32 As of September 30, 2023 Equity WAEP* Number of Shares Common Stock 51,025,060 Stock Options $2.82 6,043,164 RSUs $3.15 402,500 Warrants ** $11.13 10,310,543 Fully Diluted Shares 67,781,267 *Weighted Average Exercise Price **Actual warrants total 15,437,918
Slide 33: Vivani Medical, Inc. contact information
Vivani Medical, Inc. Lead programs NPM - 119 and NPM - 115 are miniature, six - month, GLP - 1 implants under development for the treatment of type 2 diabetes and chronic weight management in obese or overweight patients, respectively. Vivani’s pipeline also contains NPM - 139, using an undisclosed