Vivani Medical, Inc. · NASDAQ:VANI
Vivani Medical — Investor Presentation (August 2023)
27 slides from Vivani Medical's investor presentation, Aug 29, 2023
Slide 1: Vivani Medical, Inc. Guaranteed Adherence. Better Outcomes.
Vivani Medical, Inc. Guaranteed Adherence. Better Outcomes. Nasdaq: VANI August 28, 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 under development for the treatment of patients with type 2 diabetes (T2D) and obesity. Vivani’s First In Human Phase 2 clinical study of NPM - 119 in T2D patients, named LIBERATE - 1, was placed on Clinical Hold
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: Near-Constant and 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-RA Market
Targeting the Rapidly Growing GLP - 1 RA Market >$20B in 2022 & >$35B Expected in 2028 Vivani’s Lead Program NPM - 119
Slide 12: 6-Month Exenatide Implant for Type 2 Diabetes and Obesity
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: 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 13 35 30 25
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 may be 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 le
Slide 17: Well-positioned to avoid Intarcia's device technology 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: 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 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 <10.0% • On non -
Slide 20: Clinical + Regulatory Development Near-Term Plan
NPM - 119 Clinical + Regulatory Development Near - Term Plan Year(s) Milestone Status 2023 IND filed to support Ph 2a (LIBERATE - 1) clinical study July 14, 2023 2023 FDA provided Clinical Hold letter and CMC deficiencies August 18, 2023 2023 Vivani submitted Complete Response to Clinical Hold Augus
Slide 21: 12-Week 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 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: Financial Information
Vivani Medical, Inc. Financial Information
Slide 24: Q2 2023: P&L Statement
Vivani Medical, Inc. Q2 2023: P&L Statement 24 In Thousands, except Share Data Jun. 30, 2023 Jun. 30, 2022 Jun. 30, 2023 Jun. 30, 2022 Operating expenses: Research and development, net of grants 3,864 3,203 7,819 5,883 General and administrative 3,139 884 5,785 2,112 Total operating expenses 7,003 4
Slide 25: Q2 2023: Balance Sheet
Vivani Medical, Inc. Vivani Medical, Inc. Q2 2023: Balance Sheet 25 In Thousands Jun. 30, 2023 Dec. 31, 2022 ASSETS Current assets: Cash and cash equivalents 32,486$ 45,076$ Prepaid expenses and other current assets 3,669 2,452 Total current assets 36,155 47,528 Property and equipment, net 1,142 1,1
Slide 26: Q2 2023: Cap Table
Vivani Medical, Inc. Q2 2023: Cap Table 26 As June 30, 2023 Equity WAEP* Number of Shares Common Stock 50,798,799 Stock Options $2.79 6,139,233 RSUs $3.15 402,500 Warrants ** $11.13 10,310,543 Fully Diluted Shares 67,651,075 *Weighted Average Exercise Price **Actual warrants total 15,437,918 includi
Slide 27: Vivani Medical, Inc.
Vivani Medical, Inc. Lead program NPM - 119 is a miniature, 6 - month, GLP - 1 implant under development for the treatment of patients with type 2 diabetes (T2D) and obesity. Vivani’s First In Human Phase 2 clinical study of NPM - 119 in T2D patients, named LIBERATE - 1, was placed on Clinical Hold