Vivani Medical, Inc. · NASDAQ:VANI
Vivani Medical — Q2 2024 Earnings Presentation
33 slides from Vivani Medical's earnings presentation, Aug 13, 2024
Slide 1: Vivani Medical, Inc. – Guaranteed Adherence
www.vivani.com Vivani Medical, Inc. Guaranteed Adherence. Adherence Adherence. August 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 "safe ha
Slide 3: Vivani Executive Leadership Team
Vivani Executive Leadership Team Adam Mendelsohn PhD – CEO/Director 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 Donal
Slide 4: Vivani Medical, Inc.
Vivani Medical, Inc. An innovative, biopharmaceutical company developing a portfolio of ultra long-acting, miniature, drug implants to treat chronic diseases. NanoPortal™ platform technology enables the design of implants aimed at improving medication non-adherence and tolerability.Lead program NPM-
Slide 5: Company Pipeline
Company Pipeline If Approved, Vivani Products will Compete in Markets with Large Potential Indication Feasibility Pre-Clinical Clinical Market Size* Human Obesity NPM-115 high-dose exenatide >$60B Human Type 2 Diabetes NPM-119 exenatide >$60B Human Obesity NPM-139 semaglutide >$60B Feline Pre- Diabe
Slide 6: Drug Implants Proprietary Platform Technology
Drug Implants Proprietary Platform Technology .
Slide 7: NanoPortal: Innovative Delivery Technology
NanoPortalTM: Innovative Delivery Technology Designed to assure adherence Minimally-fluctuating and tunable delivery profiles Potential application with many molecular types Drug Reservoir Nanotube Membrane .
Slide 8: NanoPortal: How it Works
NanoPortalTM: 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 Pore too small: No release Pore target size: Near constant release Pore too large: Burst r
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 1st hour of release, which was ~7 µg for the high-dose and ~4 µg for the low-dose. Values are mean ± SD. *Release-rates include exenatide and related substan
Slide 10: NanoPortal is a Platform Technology
NanoPortalTM is a Platform Technology Broad Potential Application Can Support Portfolio of New Drug Implants Minimized Implant Size Extendable Implant Duration Tunable Delivery Rate Tunable Delivery Profile
Slide 11: Vivani Lead Program NPM-115 High-Dose Exenatide Implant
Vivani Lead Program NPM-115 High-Dose Exenatide Implant for Chronic Weight Management Targeting the Rapidly Growing GLP-1 RA Market .
Slide 12: Lead Product NPM-115: 6-Month Exenatide Implant
Lead Product NPM-115: 6-Month Exenatide (Glucagon-like Peptide 1 Receptor Agonist) Implant for Chronic Weight Management in Obese or Overweight Patients Tremendous unmet medical need in Obesity1: 764M people living with obesity 15M (2%) taking an anti-obesity medication GLP-1 monotherapy may provide
Slide 13: Weight Loss Medicines Associated With Adherence Challenges
Weight Loss Medicines Associated With Adherence Challenges Recent retrospective cohort study (n=1,911) reported improved medication persistence with semaglutide of 40% after one year The remaining opportunity for an additional 60% improvement in persistence is significant and will translate to impro
Slide 14: NPM-115 comparable weight loss to semaglutide in preclinical study
NPM-115 associated with comparable weight loss to semaglutide in preclinical study 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/week), c
Slide 15: Exenatide with NanoPortal associated with durable body weight effects
Exenatide delivered with NanoPortal™ technology is associated with durable body weight effects 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). (A)
Slide 16: Proposed First-in-Human Trial: LIBERATE-1
Proposed First-in-Human Trial: LIBERATE-1 Primary Objectives: Safety/tolerability assessment and full pharmacokinetic characterization. Changes in weight will also be assessed. Key Inclusion/Exclusion Criteria: 18-55 years old; overweight or obese (BMI 27-40) Otherwise healthy (no T2DM, normal renal
Slide 17: NPM-115 Clinical + Regulatory Development Near-Term Plan
NPM-115 Clinical + Regulatory Development Near-Term Plan Year(s) Milestone Status 2023 Announced Designation of NPM-115 (high dose exenatide) November 2023 2024 Reported Positive Weight Loss in Preclinical Study February 2024 2024 Submit Application to Human Research Ethics Committee to Study Exenat
Slide 18: NPM-119 Exenatide Implant for Type 2 Diabetes
NPM-119 Exenatide Implant for Type 2 Diabetes Targeting the Rapidly Growing GLP-1 RA Market .
Slide 19: NPM-119 Exenatide Implant for Type 2 Diabetes
NPM-119 Exenatide Implant for Type 2 Diabetes Targeting the Rapidly Growing GLP-1 RA Market Lead Product (NPM-119): 6-Month Exenatide (Glucagon-like Peptide 1 Receptor Agonist) Implant for Type 2 Diabetes 1 2023 Novo Nordisk Annual Report 2 Guo 2016 2, 3 Carls et al., 2017 4 IMS 2013 Report Signific
Slide 20: NPM-119 Implant and Applicator
NPM-119 Implant and Applicator .
Slide 21: Current Drug Adherence Challenge
Current Drug Adherence Challenge "Drugs don't work in people that don't take them" NPM-119* Designed to Enable 100% Adherence through Implant Duration Orals and injectables do not guarantee adherence Approximately 50% of patients do not meet glycemic targets primarily due to nonadherence Dual Incent
Slide 22: Intarcia's ITCA 650 may be a relevant value analog
Intarcia’s1 ITCA 650 (6-month exenatide implant) may be a relevant value analog for NPM-119 Value of long-term GLP-1 (exenatide) implant externally validated previously 2014 – Intarcia signed ITCA 650 deal with Servier (excluding US + Japan) $171M up-front, $880M milestones, and double-digit royalti
Slide 23: NanoPortal positioned to avoid ITCA 650 device challenges
NanoPortal is well-positioned to avoid ITCA 650’s device technology challenges Osmotic Pump (Intarcia) NanoPortalTM (NPM-119) 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 fl
Slide 24: Patient research indicates strong adoption potential
Patient research indicates strong adoption potential for a miniature, 6-month exenatide implant 56% of patients responded “likely” or “definitely” to get an exenatide implant if FDA approved, prescriber recommended, and covered by insurance dQ&A insights reported market research during FDA Advisory
Slide 25: Prescriber and Payer research support
Prescriber and Payer research also provide strong support for a miniature, 6-month exenatide implant Prescribing Rating, Average 8.3 out of 10 Rating: Overall, using a scale of 1 to 10, where 1 is not at all likely and 10 is extremely likely, how likely are you to prescribe NPM-119? Adherence = Lowe
Slide 26: 6-Month exenatide implant preclinical proof-of-concept achieved
6-Month exenatide implant preclinical proof-of-concept achieved Pharmacokinetics of 6-month exenatide implant in male Sprague-Dawley rats (n=6) 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 con
Slide 27: NPM-119 Clinical + Regulatory Development Near-Term Plan
NPM-119 Clinical + Regulatory Development Near-Term Plan Year(s) Milestone Status 2024 Clinical Hold Lifted; IND cleared June 2024 June 13, 2024 – Vivani announced that the FDA lifted the clinical hold, clearing the NPM-119 IND to enable the evaluation of its exenatide implant in patients with type
Slide 28: 12-Week exenatide implant PK in Rats
12-Week exenatide implant PK in Rats Pharmacokinetics of 3-month exenatide implant in male Sprague-Dawley rats (n=8) Exenatide antibody-positive animals are not included in this data set. Values are mean ± SD. * The estimated exenatide EC50 is 51.4 pg/mL when exenatide antibody titers are < 125 and
Slide 29: Financial Information
Vivani Medical, Inc. Financial Information .
Slide 30: Q2 2024: P&L Statement
Vivani Medical, Inc. Q2 2024: P&L Statement In Thousands, except Share Data Jun. 30, 2024 Jun. 30, 2023 Jun. 30, 2024 Jun. 30, 2023 Condensed Consolidated Statement of Operations 3 Months Ended 6 Months Ended Operating expenses: Research and development, net of grants 3,513 3,864 7,239 7,819 General
Slide 31: Q2 2024: Balance Sheet
Vivani Medical, Inc. Q2 2024: Balance Sheet Condensed Consolidated Balance Sheets (unaudited) In Thousands Jun. 30, 2024 Dec. 31, 2023 ASSETS Current assets: Cash and cash equivalents $ 24,919 $ 20,654 Prepaid expenses and other current assets 1,418 2,408 Total current assets 26,337 23,062 Property
Slide 32: Q2 2024: Cap Table
Vivani Medical, Inc. Q2 2024: Cap Table As of June 30, 2024 Equity Common Stock Stock Options RSUs Warrants Fully Diluted Shares WAEP* $2.55 - $3.39 Number of Shares 55,196,703 6,615,656 695,000 10,484,342 70,137,371 *Weighted Average Exercise Price .
Slide 33: Vivani Medical, Inc.
Vivani Medical, Inc. An innovative, biopharmaceutical company developing a portfolio of ultra long-acting, miniature, drug implants to treat chronic diseases. NanoPortal™ platform technology enables the design of implants aimed at improving medication non-adherence and tolerability. Lead program NPM