Vivani Medical, Inc. · NASDAQ:VANI
Vivani Medical — Investor Presentation (March 2024)
34 slides from Vivani Medical's investor presentation, Mar 26, 2024
Slide 1: www.vivani.com March 2024
Nasdaq: VANI www.vivani.com March 2024
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 Vivani 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/
Slide 4: Vivani Medical, Inc.
Vivani Medical, Inc. 4 Lead programs NPM - 115 and NPM - 119 are miniature, six - month, GLP - 1 (exenatide) implants under development for the treatment of chronic weight management in obese or overweight patients and type 2 diabetes, respectively. NPM - 139 (semaglutide implant) is also under deve
Slide 5: Company Pipeline
Feline Pre - Diabetes & Diabetes >$0.5B Human Obesity >$50B 5 Company Pipeline If Approved, Vivani Products will Compete in Markets with Large Potential Indication Feasibility Pre - Clinical Clinical Market Size* Human Type II Diabetes Human Obesity NPM - 119 exenatide >$20B >$50B NPM - 139 Vivani *
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 TM : 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 TM : How it Works... Pore too small: No release Pore target size: Near constant release 8 Pore too large: Bur
Slide 9: Near-constant and minimally-fluctuating release
Near - constant and minimally - fluctuating release Day 1 timepoint includes cumulative release over the first day including a separately measured 1 st hour of release, which was ~7 µg for the high - dose and ~4 µg for the low - dose. Values are mean ± SD. Fluctuations during each 2.5 - hour interva
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: NPM-115 for Chronic Weight Management
Targeting the Rapidly Growing GLP - 1 RA Market Vivani Lead Program NPM - 115 High - Dose Exenatide Implant for Chronic Weight Management
Slide 12: Lead Product NPM-115: 6-Month Exenatide Implant for Chronic Weight Management
• Tremendous unmet medical need in Obesity 1 : • 764M people living with obesity • 15M (2%) taking an anti - obesity medication • GLP - 1 monotherapy may provide adequate weight loss for the majority of patients 2 • Preliminary preclinical data with NPM - 115 has demonstrated similar magnitude of we
Slide 13: Weight Loss Medicines Associated With Adherence Challenges
100% 75% 50% 25% 0% • The remaining opportunity for an additional 60% improvement in persistence is significant and will translate to improved patient outcomes • NPM - 115 (exenatide implant) is designed to guarantee adherence for 6 months / implant Recent retrospective cohort study (n=1,911) report
Slide 14: NPM-115 comparable weight loss to semaglutide in preclinical studies
NPM - 115 is associated with comparable weight loss to semaglutide in preclinical studies 14 Weight loss in high fat diet - induced obese mice. (A) % weight change from baseline for a single administration of NPM - 115 (exenatide, ~530 nmol/kg/day) vs weekly Ozempic injections (semaglutide, 2,700 nm
Slide 15: Exenatide with NanoPortal associated with durable body weight effects
Exenatide delivered with NanoPortal™ technology is associated with durable body weight effects 15 Weight difference from control in healthy Sprague - Dawley Rats. % weight change from baseline for a single administration of NPM - 119 (exenatide, ~320 nmol/kg/day) corrected to control (vehicle implan
Slide 16: NPM-115 Clinical + Regulatory Development Near-Term Plan
NPM - 115 Clinical + Regulatory Development Near - Term Plan November 2023 – Vivani announced the designation of NPM - 115 (high - dose exenatide implant) and initiation of the development program for chronic weight management. February 2024 – Company reported positive preclinical study results demo
Slide 17: Targeting the Rapidly Growing GLP-RA Market: Exenatide Implant for Type 2 Diabetes
Targeting the Rapidly Growing GLP - 1 RA Market Vivani Lead Program NPM - 119 Exenatide Implant for Type 2 Diabetes
Slide 18: Lead Product: 6-Month Exenatide Implant for Type 2 Diabetes
1 2023 Novo Nordisk Annual Report 2 Guo 2016 2,3 Carls et al., 2017 4 IMS 2013 Report • Significant unmet need in Diabetes 1 : • 537M people living with diabetes • ~ 15% in good control • Non - adherence is the primary reason for low, real - world effectiveness 2,3 • Guaranteed adherence will produc
Slide 19: Implant and Applicator
NPM - 119 Implant and Applicator 19
Slide 20: Current Drug Adherence Challenge
Ozempic Januvia Invokana NPM - 119* 100% 75% 50% 25% 0% GLP - 1 agonist, weekly injection Mody et al., 2022 DPP - 4 inhibitors, daily pills Polonsky et al.,2016 SGLT - 2 daily pills Cai et al., 2017 GLP - 1 implant every 6 months • Orals and injectables do not guarantee adherence • Approximately 50%
Slide 21: Intarcia's ITCA 650 as a relevant value analog
Intarcia’s 1 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
Slide 22: Positioned to avoid ITCA 650'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 23: Patient market research indicates strong adoption potential
Never taken a GLP - 1 RA Patient market research indicates strong market adoption potential for a miniature, 6 - month exenatide implant dQ&A insights reported market research during FDA Advisory Board to review ITCA 650 (exenatide implant) on September 21, 2023 23 56% of patients responded “likely”
Slide 24: Prescriber and payer research support a 6-month exenatide implant
0 2 4 6 8 10 Likely to Prescribe (1=not likely, 10=extremely likely) Primary Care Physicians (n=10) Prescribing Rating, Average 8.3 out of 10 Prescriber and Payer research also provide strong support for a miniature, 6 - month exenatide implant Rating : Overall, using a scale of 1 to 10, where 1 is
Slide 25: 6-month preclinical proof-of-concept achieved
6 - Month NPM - 119 preclinical proof - of - concept achieved Implants removed * 25 Pharmacokinetics of 6 - month NPM - 119 in male Sprague - Dawley rats Exenatide antibody - positive animals are not included in this data set. Values are mean ± SD. *2 of 6 implants are responsible for higher Day 1 e
Slide 26: Clinical and Regulatory Pathway
NPM - 119 Clinical and Regulatory Pathway
Slide 27: Proposed First-in-Human Trial: LIBERATE-1
Proposed First - in - Human Trial: LIBERATE - 1 Primary Objectives: Safety/tolerability assessment and full PK characterization Glycemic control (HbA1c) and weight will also be assessed Randomize 12 Weeks Key Inclusion/Exclusion Criteria • T2DM and HbA1c <8.5% • On non - exenatide GLP - 1 therapy (d
Slide 28: Clinical + Regulatory Development Near-Term Plan
NPM - 119 Clinical + Regulatory Development Near - Term Plan July 14, 2023 – Vivani submitted an Investigational New Drug to support a proposed First in Human study also know as LIBERATE - 1 to explore the full pharmacokinetic profile of NPM - 119 in patients with type 2 diabetes. August 18, 2023 –
Slide 29: 3-Month PK in Rats
12 - Week NPM - 119 PK in Rats Intended for explant at 12 weeks in LIBERATE - 1, implants left in place for this study 29 Pharmacokinetics of 3 - month NPM - 119 in male Sprague - Dawley rats Exenatide antibody - positive animals are not included in this data set. Values are mean ± SD. * The estimat
Slide 30: Vivani Medical, Inc. Financial Information
Vivani Medical, Inc. Financial Information
Slide 31: Q4 2023: P&L Statement
Vivani Medical, Inc. Q4 2023: P&L Statement 31 In Thousands, except per Share Data Dec. 31, 2023 Dec. 31, 2022 Dec. 31, 2023 Dec. 31, 2022 Operating expenses: Research and development, net of grants 4,708$ 4,427$ 16,968$ 14,169$ General and administrative, net of grants 1,509 3,363 9,997 7,072 Total
Slide 32: Q4 2023: Balance Sheet
Vivani Medical, Inc. Vivani Medical, Inc. Q4 2023: Balance Sheet 32 In Thousands Dec. 31, 2023 Dec. 31, 2022 ASSETS Cash and cash equivalents 20,654$ 45,076$ Prepaid expenses and other current assets 2,408 2,452 Total current assets 23,062 47,528 Property and equipment, net 1,729 1,182 Right-of-use
Slide 33: Q4 2023: Cap Table
Vivani Medical, Inc. Q4 2023: Cap Table 33 As of December 31, 2023 Equity WAEP* Number of Shares Common Stock 51,031,097 Stock Options $2.60 6,090,617 RSUs - 402,500 Warrants** $11.60 9,733,068 Fully Diluted Shares 67,257,282 *Weighted Average Exercise Price
Slide 34: Vivani Medical, Inc.
Vivani Medical, Inc. 34 Lead programs NPM - 115 and NPM - 119 are miniature, six - month, GLP - 1 (exenatide) implants under development for the treatment of chronic weight management in obese or overweight patients and type 2 diabetes, respectively. NPM - 139 (semaglutide implant) is also under dev