Vivani Medical, Inc. · NASDAQ:VANI
Vivani Medical — Investor Presentation (March 2023)
27 slides from Vivani Medical's investor presentation, Mar 21, 2023
Slide 1: Vivani Medical, Inc. Guaranteed Adherence. Better Outcomes.
Vivani Medical, Inc. Guaranteed Adherence. Better Outcomes. Nasdaq: VANI March 21, 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 Nano Precision Medical 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 Mende
Slide 4: Vivani Medical, Inc.
Vivani Medical, Inc. Lead program NPM - 119 is a miniature, 6 - month, GLP - 1 implant for the treatment of patients with Type 2 Diabetes. A Phase 2 clinical study of NPM - 119 in patients is planned to initiate in 2023. In March, we announced the proposed initial public offering of our Neuromodulat
Slide 5: Company Pipeline
Company Pipeline If Approved, Vivani Candidates will Compete in Markets with Large Potential * Estimated Market Sizes where Vivani candidates would compete, if approved; Does not represent future sales or revenue estim ate s of Vivani candidates ** In Partnership with Okava Pharmaceuticals, Inc. ***
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 and Minimally-Fluctuating Release
0 20 40 60 80 100 120 0 30 60 90 120 150 In Vitro Release - Rate ( µ g/day)* Time (days) High-Dose (n=6) Low-Dose (n=6) 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 -
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-RA Market
Targeting the Rapidly Growing GLP - 1 RA Market $13B in 2020 & $23B Expected in 2026 Vivani’s Lead Program NPM - 119
Slide 12: 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: ~$23B GLP-1 Market Opportunity Expected 2026
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 25 20 15 10 5 0 Expected 2026 ~$23B GLP - 1 Market Opportunity* World - wide Sales ($Billions) * Evaluate Pharma 08 June 2021 13
Slide 14: Current Drug Adherence Challenge
Januvia Trulicity Invokana NPM - 119* 100% 75% 50% 25% 0% DPP - 4 inhibitors, daily pills Polonsky et al.,2016 GLP - 1 weekly injections Modyet al., 2018 SGLT - 2 daily pills Cai et al., 2017 GLP - 1 implant every 6 months • Orals and injectables do not guarantee adherence • Approximately 50% of pat
Slide 15: Guaranteed adherence is expected to deliver improved health outcomes
• Varying levels of adherence are associated with different health outcomes • Different health outcomes may not be attributable to drug substance alone • The American Diabetes Association (ADA) Standard of Care guidelines encourage treatment options that address adherence Guaranteed adherence is exp
Slide 16: Intarcia's ITCA as a relevant value analog
Intarcia’s 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 lead
Slide 17: NanoPortal vs. Osmotic Pump device comparison
(Intarcia) • FDA has concerns about daily variations in release being responsible for clinical safety issues • Larger Device (4mm x 45mm) • Insertion using larger 6 - gauge needle • Minimally fluctuating release profile observed in pre - clinical studies • Smaller Device (2.2mm x 21.5mm) • Insertion
Slide 18: Clinical and Regulatory Pathway
NPM - 119 Clinical and Regulatory Pathway
Slide 19: Proposed First in Human Trial: LIBERATE-1
Proposed First in Human Trial: LIBERATE - 1 Randomize 12 Weeks Key Inclusion/Exclusion Criteria • T2DM and HbA1c ≥6.5% and <10.0% • On non - exenatide GLP - 1 therapy (discontinued upon enrollment) • May be taking their GLP - 1 in combination with up to 2 of the following: metformin, TZD, SGLT - 2 i
Slide 20: Clinical + Regulatory Development Near-Term Plan
NPM - 119 Clinical + Regulatory Development Near - Term Plan Year(s) Milestone Status 2020 FDA Pre - IND Meeting Completed Mid - 2023 File IND to support Ph 2 (LIBERATE - 1) clinical study On - Track 2024 Deliver LIBERATE - 1 top - line results Projected We expect to utilize the 505(b)(2) pathway, w
Slide 21: 12-Week PK for LIBERATE-1
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 for LIBERATE - 1 (n=8) * Exenatide antib
Slide 22: 6-Month 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 23: Vivani Medical, Inc. Financial Information
Vivani Medical, Inc. Financial Information
Slide 24: Pro-Forma P&L Statement
Vivani Medical, Inc. Pro - Forma P&L Statement 24 In Thousands, except Share Data Sep. 30, 2022 Sep. 30, 2021 Sep. 30, 2022 Sep. 30, 2021 Operating expenses: Research and development, net of grants 3,855$ 2,868$ 9,738$ 8,027$ Clinical and regulatory, net of grants 4 — 4 — General and administrative
Slide 25: Pro-forma Balance Sheet
Vivani Medical, Inc. Vivani Medical, Inc. Pro - forma Balance Sheet In Thousands Sep. 30, 2022 Dec. 31, 2021 ASSETS Current assets: Cash and cash equivalents 51,684$ 2,178$ Prepaid expenses and other current assets 2,779 291 Total current assets 54,463$ 2,469$ Total assets 57,022$ 5,453$ LIABILITIES
Slide 26: Post Merger Cap Table
Vivani Medical, Inc. Post Merger Cap Table As of September 30, 2022 Equity WAEP* Number of Shares Common Stock 50,735,770 Options $3.21 5,026,987 Warrants** $5.29 10,310,543 Fully Diluted Shares 66,073,300 * Weighted Average Exercise Price ** Actual warrants total 15, 431,169 including 7,680,938 for
Slide 27: Vivani Medical, Inc.
Vivani Medical, Inc. Lead program NPM - 119 is a miniature, 6 - month, GLP - 1 implant for the treatment of patients with Type 2 Diabetes. A Phase 2 clinical study of NPM - 119 in patients is planned to initiate in 2023. In March, we announced the proposed initial public offering of our Neuromodulat