Vivani Medical, Inc. · NASDAQ:VANI
Vivani Medical — Second Sight Medical Products — Merger or Acquisition (February 2022)
25 slides from Vivani Medical's merger presentation, Feb 8, 2022
Slide 1: Second Sight Medical Products Proposed Merger With Nano Precision Medical
February 8, 2022 Second Sight Medical Products Proposed Merger With Nano Precision Medical
Slide 2: Forward Looking Statement
Forward Looking Statement The following slides and any accompanying oral presentation contain forward - looking statements within the meaning of Section 27 A of the Securities Act of 1933 , as amended, and Section 21 E of the Securities Exchange Act of 1934 , as amended, which are intended to be cov
Slide 3: Transaction Overview
Additional Financing • None associated with this transaction Transaction Overview Transaction Highlights • Nano Precision Medical (NPM) becomes a wholly - owned subsidiary of Second Sight Medical Products (Nasdaq: EYES)* • Second Sight will issue ~ 134M shares to acquire full ownership in NPM. Secon
Slide 4: Company Overview
Company Overview 4 Combined product pipeline addresses over $50 billion market opportunity Solid cash position of $69M+ enables advancement of lead program NPM - 119 and continued exploration of the Orion II business opportunity Experienced leadership team capable of bringing drugs, medical devices,
Slide 5: Combined Company Pipeline Addressing Indications with Significant Multi-Billion Dollar Market Opportunities
Combined Company Pipeline Addressing Indications with Significant Multi - Billion Dollar Market Opportunities *In Partnership with Okava Pharmaceuticals, Inc. **Feasibility in progress with two non - exenatide compounds with two separate top 5 diabetes - focused pharma companies. Indication Feasibil
Slide 6: Business Overview
Business Overview
Slide 7: NanoPortal: Innovative Delivery Technology
Works with many molecular types Adherence assured 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 be utilized to achieve desirable release profiles over time, including near constant release NanoPortal : How it Works... Pore too small: No release Pore target sized: Near constant release Pore too l
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: Addressing the Rapidly Growing GLP-RA Market
Addressing the Rapidly Growing GLP - 1 RA Market $13B in 2020 & $23B Expected in 2026 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 effectiveness 1,2 • Guaranteed adherence will produce significant value 3 • 4 months of in vivo verification; 6 months in development • FDA - confirmed feasibility of 505(b)(2) streamlined approval path
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 ~$23B GLP - 1 Market Opportunity Data consolidated by Evaluate. World - wide Sales ($Billions)
Slide 13: Current Drug Adherence Challenge
Januvia Trulicity Invokana Implant 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 patie
Slide 14: Best-in-Class Adherence, Best-in-Class Outcomes
• Most GLP - 1 products demonstrate good clinical outcomes • Varying levels of adherence are responsible for different clinical outcomes • Different outcomes are not attributable to drug substance Best - in - Class Adherence Best - in - Class Outcomes Drug Substance + Drug Device = Drug Product NPM
Slide 15: Intarcia's Proven Potential Value
Intarcia's Proven Potential Value is Relevant to NPM - 119 Servier’s Intarcia deal: ⚬ Rights outside the U.S. and Japan (1/3 of world market) sold to Servier for $171M up - front, $880M in milestone payments, and double - digit royalties Intarcia financings: ⚬ 2017 financing pre - submission valued
Slide 16: Intarcia's Device Technology Challenges are Not Relevant to NanoPortal
(Intarcia) • FDA has concerns about daily variations in release • Larger Device (4mm x 45mm) • Insertion using larger 6 - gauge needle • Minimally fluctuating release profile • Smaller Device (2.2mm x 21.5mm) • Insertion using smaller 11 - gauge needle Intarcia's Device Technology Challenges are Not
Slide 17: Clinical and Regulatory Pathway
Clinical and Regulatory Pathway
Slide 18: First in Human Trial: LIBERATE
First in Human Trial: LIBERATE - 1 Randomize 12 Weeks • HbA1c ≤8.5% • On any of the following alone or in combination: metformin, DPP - 4, SGLT2 • Excluded: GLP - 1, SU, insulin • HbA1c >6.5 ܽ ݊ ݀ ≤9.0% • On any of the following alone or in combination: metformin, DPP - 4, SGLT2 • Must be on non - e
Slide 19: Clinical + Regulatory Development Plan
NPM - 119 Clinical + Regulatory Development Plan 2020 2021 2024 2025 First - In - Human (FIH) Development Regulatory & Milestones 2022 2023 2026 Pre - clinical & Other Development Pivotal Development 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q FDA Meeting PK/T
Slide 20: Neurostimulation Implant Technology to Treat Blindness: ORION II
Neurostimulation Implant Technology to Treat Blindness ORION II
Slide 21: Argus II and Orion Implant Highlights
21 Argus II Developed, Approved, and Commercialized Argus II and Orion Implant Highlights Orion Leverages Argus II Technology Platform • Orion II is an electronic brain implant (potential for much broader patient population) • Early clinical results are encouraging • Exploring the best path towards
Slide 22: Orion Platform - Potential to Treat Virtually All Forms of Blindness
Orion ® Platform - Potential to Treat Virtually All Forms of Blindness Orion II Initial addressable market represents $1 billion+ opportunity 1 500,000+ Legally Blind 50,000 - 100,000 with Light Perception or worse Legally blind due to glaucoma, diabetic retinopathy, optic nerve disease, eye trauma
Slide 23: Orion II Potential Path Forward
Orion II Potential Path Forward Regulatory, Clinical and Commercialization Considerations • Initial clinical pilot study at UCLA and Baylor College of Medicine on - going; 3 - year data encouraging • Argus II learnings will inform development programs • Patient Preference Study – Part one – informs
Slide 24: Executive Leadership Team
24 Executive Leadership Team • Co - founder/Co - inventor of NPM 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 PhD – CEO/Directo
Slide 25: Summary of Proposed Merger
25 Summary of Proposed Merger Combined product pipeline addresses over $50 billion market opportunity Solid cash position of $69M+ enables advancement of lead program NPM - 119 and continued exploration of the Orion II business opportunity Experienced leadership team capable of bringing drugs, medic
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