Check-cap Ltd. · NASDAQ:MBAI
Check-cap — Investor Presentation (September 2018)
25 slides from Check-cap's investor presentation, Sep 5, 2018
Slide 1: Corporate Presentation September 2018
Corporate Presentation September 2018 www.check-cap.com Ticker: CHEK (NASDAQ)
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
* Our Mission Colon cancer prevention through patient friendly screening
Slide 4: Overview
* Overview Headquarters: Isfiya, IsraelTicker: CHEK (NASDAQ)Employees: 50Shares outstanding: 5.3mn (6/30/18)Cash & equivalents: $20mn (6/30/18) Amounts raised: $25.5 million IPO With simultaneous private placement in 2015 $11.2 million totalRegistered direct offerings in 2016-2017$20.2 millionUnderw
Slide 5: Executive Management
* Executive Management Alex Ovadia CEODr. Yoav KimchyFounder & CTO Lior Torem CFO & VP OperationsBoaz ShpigelmanVP R&D BOD Dr. Walt RobbYuval YanaiDr. Mary Jo GormanXQ LiClara Ezed Member of the BOD of Check -Cap US Inc. our U.S Subsidiary Steve Hanley Chairman (1)
Slide 6: Colon Cancer - Screening is Key to Prevention
* Colon Cancer - Screening is Key to Prevention Low screening adherence Mortality world-wide ~ 700,000 annuallyPrevention = Detection of Pre-cancerous polyps Our solution - Patient friendly prep-free screening Source: GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2
Slide 7: C-Scan - Preparation-Free Colon Screening
* 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 8: C-Scan - Disruptive Imaging Technology
* C-Scan®- Preparation-Free Colon Screening Disruptive Imaging Technology Compton Back-scattering X-Ray Fluorescence Capsule scanning over a polyp Exclusive Motility Analysis + As the capsule moves naturally, it scans the inner lining of the colon in a 360 degree arc, scanning only when in motion Ca
Slide 9: Patient procedure steps
* 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 10: Colon Cancer Prevention Market Opportunity
10 China 310k 149k Japan 113k 48k Expected to increase by 60% by 2030 Deaths world-wide ~ 700k More lives could be saved Colon Cancer Prevention Market Opportunity Sources: * - Population age +50 at average risk - United Nations DESA/ Population Division – World Population Prospects 2017 (North Amer
Slide 11: Prevention Opportunity
* ~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 12: Screening Rates U.S, EU, China
* 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 Ge
Slide 13: Barriers to Colonoscopy screening in U.S
* 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 14: Screening methods: adherence vs sensitivity
14 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 15: Pathway to commercialization
* Pathway to commercialization >250 capsules ingested, clear safety recordISO 13485 Certification and CE mark attainedMarketing approval in Israel U.S. clinical pathway realization in planning Ongoing manufacturing line buildup at GE Discussion with potential strategic partners
Slide 16: Sensitivity and specificity study results
Sensitivity C-Scan prep free screening demonstrated promising results for detecting precancerous polyps Specificity CE Post CE * 89% 80% 44% 76% * Post CE study approval Interim results evaluated on full patient population with a gender based analysis Study results Multidimensional screening through
Slide 17: Strong support from KOLs
* 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 potent
Slide 18: Clinical Value of C-Scan
* Prof. Jan Tack Clinical Value of C-Scan “"I believe that the diagnostic yield of the C-Scan system, based on the combined diagnostic test, including scan imaging and gut motility, can be accepted as an important CRC screening tool following results‘ validation on a larger data base". Jan TackProfe
Slide 19: C-Scan Advantages
* 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 colon
Slide 20: Multiple near term inflection points
* Multiple near term inflection points C-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 (1,2,3) Sales initiation in EMEA (1,2)U.S. Pivotal s
Slide 21: Robust Intellectual Property
* Core patents granted in major jurisdictions Robust Intellectual Property 33 Granted 1 Allowed21 Pending worldwide Further IP enhancement based on recent technology breakthrough
Slide 22: Investment Highlights
Revolution in CRC screening market Promising results utilizing the C-Scan improved system in Post CE approval study Strategic collaboration with GE Healthcare Robust intellectual property protection * Commercialization pathway buildup Productive discussions with regulatory agencies Investment Highli
Slide 23: Appendix
Appendix a,
Slide 24: Reimbursement for screening methods
Reimbursement for screening methods 24 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 25: X-ray Exposure Control
25 25 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