Check-cap Ltd. · NASDAQ:MBAI
Check-cap — Investor Presentation (July 2018)
25 slides from Check-cap's investor presentation, Jul 6, 2018
Slide 1: Corporate Presentation July 2018
Corporate Presentation July 2018 www.check-cap.com
Slide 2: Forward-Looking Statements
Forward-Looking StatementsThis presentation contains certain statements that may be deemed to be “forward looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. Forward looking statements appear in a number of p
Slide 3: Our Mission
3 Our Mission Colon cancer prevention through patient friendly screening
Slide 4: Colon Cancer - Screening is Key to Prevention
4 Colon Cancer - Screening is Key to Prevention Low screening adherence Mortality world-wide ~ 700K annuallyPrevention = Detection of Pre-cancerous polyps Our solution - Patient friendly prep-free screening
Slide 5: C-Scan - Preparation-Free Colon Screening
5 C-Scan®- Preparation-Free Colon Screening C-Scan® Cap C-Scan® Track Biocompatible patch worn on patient's back for Capsule Control, Tracking and Data Recording C-Scan® View Ingestible scanning capsuleGenerating Imaging Data+ Positioning Data Positioning 3D Display The C-Scan® System is not availab
Slide 6: C-Scan - Preparation-Free Colon Screening
6 C-Scan®- Preparation-Free Colon Screening As the capsule moves naturally, it scans the inner lining of the colon in a 360 degree arc, scanning only when in motion Disruptive Photon Counting Technology Compton Back-scattering X-Ray Fluorescence Stand by mode Scan mode –Capsule scanning over a polyp
Slide 7: Ingestion, Daily Routine, Excretion
7 Step I - Ingestion Patient friendly procedure Step II – Normal daily routine (2-3 days) Capsule ingestedPatch attached to patient’s back No special dietContrast agent + Fibers (1 tablespoon) with each meal Step III - Excretion Single use Capsule Patient is notified once capsule is excreted natural
Slide 8: Colon Cancer Incidence, Mortality and Market Opportunity
8 Incidence Mortality U.S 135k 50k EU 471k 228k China 310k 149k Japan 113k 48k Expected to increase by 60% by 2030 Deaths world-wide ~ 700k Most lives could be saved $42.6B Colon Cancer Prevention Market Opportunity Sources: * - Population age +50 at average risk - United Nations DESA/ Population Di
Slide 9: Prevention Opportunity
9 ~10 years Prevention Opportunity From healthy individual with pre-cancerous polyps To cancer patient Early Detection Source: Gastro 1997;112:594-692 (Winawer) Cancerous Polyp Highly preventable form of cancer
Slide 10: Screening Rates U.S, EU, China
10 Screening Rates U.S, EU, China Ages ≥ 50 Sources: CDC NHIS survey results as published in the CDC’s MMWR between 2006 and 2017 Radiology,. 2017, Ahead of Print, https://doi.org/10.1148/radiol.2017170924 (Smith) Schreuders EH, et al. Gut 2015;0:1–13. doi:10.1136/gutjnl-2014-309086 60% 20-30% U.S G
Slide 11: Barriers to Colonoscopy screening in U.S
11 Barriers to Colonoscopy screening in U.S Laxative preparation Insertion of endoscope Fasting requirements Other reasons Concern over pain Embarrassment “What do you feel is the most troubling part of colon testing?” Mayo Clinic Proc. 2007;82(6):666-671
Slide 12: Screening methods: sensitivity versus adherence
12 Prevention-Screening for cancer and polypsHigh sensitivity for pre-cancerous polyps Early Detection-Screening for cancer Low sensitivity for pre-cancerous polyps C-Scan focuses on increasing public’s willingness to screen C-Scan® CTC Colonoscopy Capsule Endoscopy FOBT, FIT Stool DNA Liquid Biopsy
Slide 13: Pathway to commercialization
13 Pathway to commercialization >200 capsules ingested, clear safety recordISO 13485 Certification and CE mark attainedU.S. clinical pathway realization in planningOngoing manufacturing line buildup at GERequest for marketing approval submitted in Israel Ongoing discussion with strategic partners
Slide 14: Strong support from KOL's
14 Prof. Seth A. Gross “C-scan is a novel approach to improve colon cancer screening that can become an alternative to current screening methods. The device generates 3D colon mapping without the need for bowl preparation through which it eliminates barriers for screening noncompliance and has poten
Slide 15: Strong correlation between scan imaging density and sensitivity
15 % Sensitivity r2 = 0.98 Scan imaging density Strong correlation between scan imaging density and sensitivity SensitivityAbility to identify polyps accuratelySpecificityAbility to identify lack of polypsScan imaging density Scans distribution along colon Specificity consistent around 89% 44% 55% 7
Slide 16: C-Scan Advantages
16 C-Scan® Advantages Patient Payer Hospital and Physician NO laxatives NO boostersNO sedation NO need for anesthesiaNO operating roomMinimal staff involved GIs focused on polyp removal Analysis anywhere – Portal based analysis suite INCREASES screening adherenceINCREASES willingness to undergo colo
Slide 17: Multiple near term inflection points
17 Multiple near term inflection points Post CE approval study interim resultsC-Scan system approved for marketing in Israel Q3/18E Q4/18E Q2/19E Q4/19E IDE approvalManufacturing line at GE readyU.S. Pilot study initiation Post CE approval study final results Sales initiation in Israel (1,2) Sales i
Slide 18: Robust Intellectual Property
18 Core patents granted in major jurisdictions Robust Intellectual Property 33 Granted 1 Allowed20 Pending worldwide
Slide 19: Financial Overview
19 Financial Overview Amounts raised: $25.5 million IPO with simultaneous private placement in 2015 $11.2 million total registered direct offerings in 2016-2017$20.2 million underwritten public offering in May 20185.3 million shares outstanding (6/30/2018)Trade on the NASDAQ: CHEK, CHEKW, CHEKZ $4.6
Slide 20: Executive Management
20 Executive Management Alex Ovadia CEODr. Yoav KimchyFounder & CTO Lior Torem CFOBoaz ShpigelmanVP R&D BOD Dr. Walt Robb (1)Yuval YanaiDr. Mary Jo GormanXQ LiClara Ezed Member of the BOD of Check -Cap US Inc. our U.S Subsidiary Steve Hanley Chairman
Slide 21: Investment Highlights
Investment Highlights Revolution in CRC screening market CE Mark approved in the European Union Strategic collaboration with GE Healthcare Robust intellectual property protection 0344 21 Commercialization pathway buildup Productive discussions with regulatory agencies
Slide 22: Appendix
Appendix
Slide 23: Reimbursement for screening methods
Reimbursement for screening methods 23 Colonoscopy (avg. including, anesthesia, biopsy, bowel prep) - Medicare $1,036 - Private sector $2,000 to $3,000CTC (Virtual colonoscopy) $436Cologuard (Stool DNA, Exact) $509 Capsule Endoscopy (Medtronic) 83,100 JPY ($776) using current exchange rate for year
Slide 24: X-ray Exposure Control
24 24 X-ray Exposure Control mSv Very Low Radiation Exposure Typical organ radiation doses from various radiologic studies 0.05mSv C-Scan Imaging Stand by mode Scan mode
Slide 25: Potential New applications
25 Potential New applications depending on potential strategic partnerships Exploring opportunities for C-Scan® technology spin offs Localized drug delivery capsuleGastro intestinal motility diagnostics capsuleSmall bowel video capsule combined with C-Scan® tracking system