Vivani Medical, Inc. · NASDAQ:VANI
Vivani Medical — Investor Presentation (February 2023)
28 slides from Vivani Medical's investor presentation, Feb 17, 2023
Slide 1: Vivani Medical, Inc. Guaranteed Adherence. Better Outcomes.
Vivani Medical, Inc. Guaranteed Adherence. Better Outcomes. Nasdaq: VANI February 16, 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. overview
Vivani Medical, Inc. B iopharm Division (formerly Nano Precision Medical) develops tiny, drug implants that provide therapeutic levels of medicine over extended periods of time, guaranteeing medication adherence. NPM - 119 (6 - month GLP - 1 implant candidate for Type 2 Diabetes) is Vivani’s main fo
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: Biopharm Division Drug Implants Proprietary Platform Technology
Biopharm Division 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 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 release over
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: Lead Product
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
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: Positioned to avoid Intarcia's device technology challenges
(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: 6-Month Preclinical Proof-of-Concept Achieved
6 - Month NPM - 119 Preclinical Proof - of - Concept Achieved EC 50 * Exenatide antibody - positive animals are not included in this data set. **2 of 6 implants are responsible for higher Day 1 exenatide concentrations. Additional optimization ongoing to yield consis ten t gradual initial PK profile
Slide 19: Clinical and Regulatory Pathway
NPM - 119 Clinical and Regulatory Pathway
Slide 20: 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 21: Clinical + Regulatory Development Near-Term Plan
NPM - 119 Clinical + Regulatory Development Near - Term Plan Year(s) Milestone Status 2020 FDA Pre - IND Meeting Completed 1H2023 File IND to support Ph 2 (LIBERATE - 1) clinical study On - Track 2023 Deliver LIBERATE - 1 top - line results Projected We expect to utilize the 505(b)(2) pathway, which
Slide 22: Neuromodulation Division ORION II Neurostimulation Implant Technology
Neuromodulation Division ORION II Neurostimulation Implant Technology to Treat Blindness
Slide 23: Orion II Current Activities and Future Considerations
Orion II Current Activities and Future Considerations • Initial clinical pilot study at UCLA and Baylor College of Medicine; 3 - year data encouraging • Confirming regulatory pathway with FDA • Patient Preference Study – Part one – informs potential adoption; encouraging results obtained • Market Ac
Slide 24: Vivani Medical, Inc. Financial Information
Vivani Medical, Inc. Financial Information
Slide 25: Pro-Forma P&L Statement
Vivani Medical, Inc. Pro - Forma P&L Statement Historical Pro forma Pro forma ($ in 000s) Second Sight NPM adjustments combined For the six months ended June 30, 2022: Net sales $ - $ - $ - $ - Cost of sales - - - Gross profit - - - Total operating expenses 5,345 7,995 (1,615) 11,725 Loss from opera
Slide 26: Pro-forma Balance Sheet
Vivani Medical, Inc. Vivani Medical, Inc. Pro - forma Balance Sheet ($ in 000s) Combined Second Sight NPM Merger pro forma For the Period ending June 30, 2022 Historical Historical adjustments as adjusted Assets Cash and cash equivalents $ 56,377 $ 3,450 $ (1,624) $ 58,203 Other assets 9,272 2,967 (
Slide 27: Post Merger Cap Table
As of August 30, 2022 Name Common (CS) Options Outstanding (1) Common Warrants (2) Total Shares, Options & Warrants Total Shares Outstanding 50,726,329 4,609,642 10,310,539 65,646,510 Total Restricted Shares (Locked- up 180 Days) 21,942,231 2,214,791 9,310,573 33,467,595 Unrestricted Shares 28,784,0
Slide 28: Vivani Medical, Inc. overview
Vivani Medical, Inc. B iopharm Division (formerly Nano Precision Medical) develops tiny, drug implants that provide therapeutic levels of medicine over extended periods of time, guaranteeing medication adherence. NPM - 119 (6 - month GLP - 1 implant candidate for Type 2 Diabetes) is Vivani’s main fo
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