Vivani Medical, Inc. · NASDAQ:VANI
Vivani Medical — Investor Presentation (September 2022)
26 slides from Vivani Medical's investor presentation, Sep 23, 2022
Slide 1: Vivani Medical, Inc. combination of Nano Precision Medical and Second Sight
Vivani Medical, Inc. combination of Nano Precision Medical and Second Sight Medical Products Nasdaq: VANI September 22, 2022
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
3 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 Men
Slide 4: Vivani Medical, Inc. overview
Vivani Medical, Inc. 4 BioPharm Division (formerly Nano Precision Medical) develops drug implant candidates to address medication non - adherence, a leading cause of poor clinical outcomes, leveraging its proprietary NanoPortal technology. NPM - 119 (GLP - 1 implant) is the priority focus of Vivani.
Slide 5: Combined Company Pipeline
Combined 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,
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: NanoPortal is a Platform Technology
Minimized Implant Size Extendable Implant Duration Tunable Delivery Rate Tunable Delivery Profile 9 NanoPortal TM is a Platform Technology Broad Potential Application Can Support Portfolio of New Drug Implants
Slide 10: 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 11: Lead Product: 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 • 5 months of in vivo pre - clinical verification; 6 - month product candidate in development •
Slide 12: GLP-1 Market Opportunity
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 25 20 15 10 5 0 12 Expected 2026 ~$23B GLP - 1 Market Opportunity* World - wide Sales ($Billions) * Evaluate Pharma 08 June 2021
Slide 13: 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 14: Guaranteed adherence 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 15: 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 $4.0B (2017) Intarcia’s lead
Slide 16: NanoPortal vs. Osmotic Pump device comparison
(Intarcia) • FDA has concerns about daily variations in release • Larger Device (4mm x 45mm) • Insertion using larger 6 - gauge needle • Minimally fluctuating release profile observed in pre - clinical studies • Smaller Device (2.2mm x 21.5mm) • Insertion using smaller 11 - gauge needle NPM - 119 we
Slide 17: Clinical and Regulatory Pathway
NPM - 119 Clinical and Regulatory Pathway
Slide 18: Proposed First in Human Trial: LIBERATE-1
Proposed First in Human Trial: LIBERATE - 1 Randomize 12 Weeks Key Inclusion/Exclusion Criteria • T2DM and HbA1c ≥6.5% and <10.0% • On non - exenatide GLP - 1 therapy (discontinued upon enrollment) • May be taking their GLP - 1 in combination with up to 2 of the following: metformin, TZD, SGLT - 2 i
Slide 19: Clinical + Regulatory Development Near-Term Plan
NPM - 119 Clinical + Regulatory Development Near - Term Plan 19 Year(s) Milestone Status 2020 FDA Pre - IND Meeting Completed 4Q2022 / 1Q2023 File IND to support Ph 2 (LIBERATE - 1) clinical study On - Track 2023 Deliver LIBERATE - 1 top - line results Projected We expect to utilize the 505(b)(2) pa
Slide 20: Neuromodulation Division ORION II
Neuromodulation Division ORION II Neurostimulation Implant Technology to Treat Blindness
Slide 21: Orion II Current Activities and Future Considerations
Orion II Current Activities and Future Considerations • Initial clinical pilot study at UCLA and Baylor College of Medicine; 3 - year data encouraging • Confirming regulatory pathway with FDA • Patient Preference Study – Part one – informs potential adoption; encouraging results obtained • Market Ac
Slide 22: Vivani Medical, Inc. Financial Information
Vivani Medical, Inc. Financial Information
Slide 23: Pro-Forma P&L Statement
Vivani Medical, Inc. Pro - Forma P&L Statement 23 Historical Pro forma Pro forma ($ 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 op
Slide 24: Pro-forma Balance Sheet
Vivani Medical, Inc. Vivani Medical, Inc. Pro - forma Balance Sheet 24 ($ 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 2,96
Slide 25: 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 26: Vivani Medical, Inc. summary
Vivani Medical, Inc. 26 BioPharm Division (formerly Nano Precision Medical) develops drug implant candidates to address medication non - adherence, a leading cause of poor clinical outcomes, leveraging its proprietary NanoPortal technology. NPM - 119 (GLP - 1 implant) is the priority focus of Vivani
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