Vivani Medical, Inc. · NASDAQ:VANI
Vivani Medical — Investor Presentation (October 2022)
27 slides from Vivani Medical's investor presentation, Oct 17, 2022
Slide 1: Vivani Medical, Inc. combination of Nano Precision Medical and Second Sight Medical Products
Vivani Medical, Inc. combination of Nano Precision Medical and Second Sight Medical Products Nasdaq: VANI October 17, 2022 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 "safe ha
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 Mendelsohn P
Slide 4: Vivani Medical, Inc.
Vivani Medical, Inc. 4 Biopharm 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 focus.
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 estimates of Vivani candidates ** In Partnership with Okava Pharmaceuticals, I
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 rel
Slide 9: NanoPortal is a Platform Technology
Minimized Implant Size Extendable Implant Duration Tunable Delivery Rate Tunable Delivery Profile 9 NanoPortalTM is a Platform Technology Broad Potential Application Can Support Portfolio of New Drug Implants
Slide 10: Targeting the Rapidly Growing GLP-1 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 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 effectiveness1,2 •Guaranteed adherence will produce significant healthcare cost savings3 •FDA indicated 505(b)(2) streamlined approval pathway may be available •~$54M raised pre-merger from inv
Slide 12: Expected 2026 ~$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 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 patients do not
Slide 14: 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 expect
Slide 15: Intarcia's ITCA may be a relevant value analog for NPM-119
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 program
Slide 16: NPM-119 well-positioned to avoid Intarcia's device technology challenges
(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 well-positioned
Slide 17: 6-Month NPM 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 18: NPM-119 Clinical and Regulatory Pathway
NPM-119 Clinical and Regulatory Pathway
Slide 19: Proposed First in Human Trial: LIBERATE
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: NPM-119 Clinical + Regulatory Development Near-Term Plan
NPM-119 Clinical + Regulatory Development Near-Term Plan 20 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) pathway, which p
Slide 21: Neuromodulation Division ORION II Neurostimulation Implant Technology to Treat Blindness
Neuromodulation Division ORION II Neurostimulation Implant Technology to Treat Blindness
Slide 22: 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 Access,
Slide 23: Vivani Medical, Inc. Financial Information
Vivani Medical, Inc. Financial Information
Slide 24: Vivani Medical, Inc. Pro-Forma P&L Statement
Vivani Medical, Inc. Pro-Forma P&L Statement 24 HistoricalPro formaPro forma($ in 000s)Second SightNPMadjustmentscombinedFor 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 operations $
Slide 25: Vivani Medical, Inc. Pro-forma Balance Sheet
Vivani Medical, Inc. Vivani Medical, Inc. Pro-forma Balance Sheet 25 ($ in 000s)CombinedSecond SightNPM Merger pro formaFor the Period ending June 30, 2022HistoricalHistorical adjustmentsas adjustedAssetsCash and cash equivalents $ 56,377 $ 3,450 $ (1,624) $ 58,203 Other assets9,272 2,967 (8,000) 4,
Slide 26: Vivani Medical, Inc. 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 (Lockedup 180 Days) 21,942,231 2,214,791 9,310,573 33,467,595 Unrestricted Shares 28,784,098
Slide 27: Vivani Medical, Inc.
Vivani Medical, Inc. 27 Biopharm 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 focus.
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