Vivani Medical, Inc. · NASDAQ:VANI
Vivani Medical — Investor Presentation (May 2024)
34 slides from Vivani Medical's investor presentation, May 13, 2024
Slide 1: Vivani Medical, Inc. Guaranteed Adherence, Better Outcomes
Nasdaq: VANI www.vivani.com Vivani Medical, Inc. Guaranteed Adherence, Better Outcomes. May 2024
Slide 2: Disclaimers
Disclaimers The following slides and any accompanying oral presentation contain forward-looking statements within the meaning of Section 27Aof 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 harb
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/Director •
Slide 4: Vivani Medical, Inc.
Vivani Medical, Inc. 4 An innovative, biopharmaceutical company developing a portfolio of miniature, long-term, drug implants to treat chronic diseases. Our NanoPortal™ platform technology enables the design of implants aimed at improving medication non-adherence and tolerability. Lead programs NPM-
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 * Estimat
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 NanoPortalTM: 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 NanoPortalTM: How it Works... Pore too small: No release Pore target size: Near constant release 8 Pore too large: Burst
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 1sthour 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 interval are within
Slide 10: NanoPortal is a Platform Technology
Minimized Implant Size Extendable Implant Duration Tunable Delivery Rate Tunable Delivery Profile NanoPortalTMis a Platform Technology Broad Potential Application Can Support Portfolio of New Drug Implants 10
Slide 11: Lead Program NPM-115 High-Dose Exenatide Implant
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 for Chronic Weight Management
•Tremendous unmet medical need in Obesity1: •764M people living with obesity •15M (2%) taking an anti-obesity medication •GLP-1 monotherapy may provide adequate weight loss for the majority of patients2 •Preclinical data with NPM-115 has demonstrated similar magnitude of weight loss for exenatide an
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) reported i
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 nmol/kg/
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 implant).
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 demonstrating
Slide 17: Lead Program NPM-119 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 NPM-119 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 Diabetes1: •537M people living with diabetes •~ 15% in good control •Non-adherence is the primary reason for low, real-world effectiveness2,3 •Guaranteed adherence will produce significan
Slide 19: NPM-119 Implant and Applicator
NPM-119 Implant and Applicator 19
Slide 20: NPM-119 Designed to Enable 100% Adherence
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% of patients
Slide 21: Intarcia ITCA 650 may be a relevant value analog for NPM-119
Intarcia’s1ITCA 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 22: NPM-119 well-positioned to avoid ITCA 650 device 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 releaseprofile observed in pre-clinical studies •SmallerDevice (2.2mm x 21.5mm) •Insertion using
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” or
Slide 24: Prescriber and Payer research support miniature exenatide implant
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 not at all likely
Slide 25: 6-Month NPM-119 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 exenatide concentr
Slide 26: NPM-119 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 (discontinued
Slide 28: NPM-119 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 –FDA provid
Slide 29: 12-Week NPM-119 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 estimated exenatide EC
Slide 30: Vivani Medical, Inc. Financial Information
Vivani Medical, Inc. Financial Information
Slide 31: Q1 2024: P&L Statement
Vivani Medical, Inc.Q1 2024: P&L Statement 31In Thousands, except per Share DataMar. 31, 2024Mar. 31, 2023Operating expenses:Research and development, net of grants3,726$ 3,955$ General and administrative, net of grants2,5012,646Total operating expenses6,2276,601Loss from operations(6,227)(6,601)Oth
Slide 32: Q1 2024: Balance Sheet
Vivani Medical, Inc. Vivani Medical, Inc.Q1 2024: Balance Sheet 32In ThousandsMar. 31, 2024Dec. 31, 2023ASSETSCash and cash equivalents29,648$ 20,654$ Prepaid expenses and other current assets1,8542,408Total current assets31,50223,062Property and equipment, net1,6891,729Right-of-use assets19,21219,6
Slide 33: Q1 2024: Cap Table
Vivani Medical, Inc.Q1 2024: Cap Table 33As of March 31, 2024 Equity WAEP* Number of Shares Common Stock 54,978,465 Stock Options $2.67 5,880,343 RSUs - 402,500 Warrants $3.38 10,961,248 Fully Diluted Shares 72,222,556
Slide 34: Vivani Medical, Inc.
Vivani Medical, Inc. 34 An innovative, biopharmaceutical company developing a portfolio of miniature, long-term, drug implants to treat chronic disease. Our NanoPortal™ platform technology enables the design of implants aimed at improving medication non-adherence and tolerability. Lead programs NPM-