Check-cap Ltd. · NASDAQ:MBAI
Check-cap — Investor Presentation (January 2019)
24 slides from Check-cap's investor presentation, Jan 7, 2019
Slide 1: Corporate Presentation January 2019
www.check-cap.com • Ticker: CHEK (NASDAQ) Colon 3DImaging Capsule CORPORATE PRESENTATIONJANUARY 2019
Slide 2: Forward-Looking Statements
Forward-Looking StatementsThis presentation contains forward-looking statements about our expectations, beliefs or intentions regarding, among other things, our ongoing and planned product development and clinical trials; the timing of, and our ability to make, regulatory filings and obtain and main
Slide 3: Our Mission
Our Mission To prevent colon cancer through the first and only preparation-free Capsule based screening methodfor precancerous polyp detection 3
Slide 4: Check-Cap at a Glance
Check-Cap at a Glance 4 * January 4, 2019 ** September 30, 2018 Advancing C-Scan® - a patient-friendly Colon 3D Imaging system NASDAQ: CHEKHeadquarters: Isfiya, IsraelMarket cap: $12.8M*Cash and equivalents: $17.6M**Received CE Mark approvalApproved for sale in Israel
Slide 5: CRC is the Third Most Commonly Diagnosed Cancer
CRC is the Third Most Commonly Diagnosed Cancer 5 Most Commonly Diagnosed Cancers 2.1 2.1 1.8* 1.3 1.0 Lung Breast Colorectal Prostate Stomach Sources:1. http://gco.iarc.fr/today/data/factsheets/cancers/10_8_9-Colorectum-fact-sheet.pdf2. https://gut.bmj.com/content/66/4/6833. https://www.cancer.org/
Slide 6: But Is Also Highly Preventable With Screening
But Is Also Highly Preventable With Screening 6 ~10 Year Prevention Opportunity Source: https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/detection.html FROM HEALTHY INDIVIDUAL WITH PRE-CANCEROUS POLYPS… …TO CANCER PATIENT Cancerous Polyp
Slide 7: Global Screening Rates Remain Low
Global Screening Rates Remain Low 7 Ages ≥50 U.S Germany 80% goal by 20181 China FOBT FIT Colonoscopy Sources:1. 2018 goal, ages 50-75 years, https://www.cdc.gov/cancer/dcpc/research/articles/crc_screening_model.htm2. Relates to ages 50 years and older, as of 2015. For colonoscopy, this includes adu
Slide 8: Barriers to Colonoscopy Screening in U.S.
Barriers to Colonoscopy Screening in U.S. 8 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?” https://www.mayoclinicproceedings.org/article/S0025-6196(11)61185-3/fulltext
Slide 9: CRC Screening Market Opportunity
CRC Screening Market Opportunity 9 American Cancer Society (ACS) concluded that new cases of CRC are increasing among younger adults, from 6% in 1990 to 11% in 20131In 2018, the ACS announced revised guidelines recommending average risk population to begin screening at age of 45 instead of 502 Sourc
Slide 10: Our Solution: C-Scan Preparation-Free Colon Screening
Our Solution: C-Scan® Preparation-Free Colon Screening 10 C-Scan® Cap C-Scan® Track Biocompatible patch worn on patient's back for Capsule Control, Tracking, and Data Recording C-Scan® View The first and only preparation-free ingestible scanning capsuleDetects precancerous polypsGenerates Imaging an
Slide 11: C-Scan: Preparation-Free Colon Screening
C-Scan®: Preparation-Free Colon Screening 11 Compton Back-scattering X-Ray Fluorescence Capsule scanning over a polyp Disruptive Imaging TechnologyAs the capsule moves naturally, it scans the inner lining of the colon in a 360-degree arc, scanning only when in motion Exclusive Motility AnalysisCapsu
Slide 12: Autonomous, Prep-Free Procedure Can Increase Adherence
Autonomous, Prep-Free Procedure Can Increase Adherence 12 STEP 1:INGESTION STEP 2:NORMAL DAILY ROUTINE Patch attached to patient’s backCapsule ingested - No special dietContrast agent + Fibers (1 tablespoon) with each meal STEP 3:EXCRETION Single use capsulePatient is notified once capsule is excret
Slide 13: C-Scan: Increasing Adherence, detecting pre-cancerous polyps
13 HIGH Sensitivity for pre-cancerous polyps LOW Sensitivity for pre-cancerous polyps C-Scan® ColonoscopyCTCCapsule Endoscopy FOBT, FITStool DNA Liquid Biopsy Sources: AGA Institute Guidelines for the Early Detection of Colorectal Cancer and Adenomatous Polyps.American Cancer Society. Colorectal Can
Slide 14: C-Scan Advantages
PHYSICIAN HOSPITAL PAYER C-Scan® Advantages 14 Proposed Solution for patients refusing or cannot undergo colonoscopyAnalysis anywhere – Portal based analysis suiteAugmented polyp removal NO need for anesthesiaNO operating roomMinimal staff involved Reduces CRC incidents and mortalitySaves treatment
Slide 15: C-Scan: Positive Interim Results - Ongoing Post-CE Approval Study
* Post CE interim results (September 2018) using version 3 of the C-Scan system compared to final results (September 2017) of earlier version of the C-Scan system used in support of CE submission ** Using the full patient population with a gender-based analysis.†P=0.0038; interim data. Final study r
Slide 16: Compelling Clinical Value: Strong Support From KOLs
Compelling Clinical Value: Strong Support From KOLs 16 “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 bowel preparation through which it eliminates barriers for scr
Slide 17: Efficient Pathway to Commercialization
Efficient Pathway to Commercialization 17 >300 capsules ingested: no reported SAEsEU - CE mark attainedFDA IDE conditional approval granted for U.S. Pilot Study Prominent U.S. hospital to conduct U.S. Pilot Study1Israeli Ministry of Health (“AMAR”) approval obtained2 U.S. – Regulatory Pathway ongoin
Slide 18: Robust Intellectual Property
Robust Intellectual Property 18 Core patents granted in major jurisdictions 36 Granted 1 Allowed 20 Pending worldwide Exploring potential new applications for C-Scan®, including:Gastrointestinal physiological data analysisLocalized drug deliveryOther potential GI tract monitoring capabilities
Slide 19: Executive Management and Board of Directors
EXECUTIVE MANAGEMENT 19 Alex Ovadia CEODr. Yoav KimchyFounder & CTO Lior Torem CFO & VP OperationsBoaz ShpigelmanVP R&D *Member of the BOD of Check-Cap US Inc., our U.S Subsidiary. Steve Hanley ChairmanDr. Walt Robb*Yuval YanaiDr. Mary Jo GormanXQ LinClara Ezed Management and Board experienced in me
Slide 20: Near-Term Major Milestones
Near-Term major Milestones 20 H2/18 H1/20E Manufacturing line at GE readyU.S. Pilot Study initiation1Post CE approval study final results Sales initiation in Israel2,3,4,5Sales initiation in EEA2,3,4 U.S. Pivotal Study initiation2,3,6 1. Pending IRB approval2. Pending strategic partnership.3. Pendin
Slide 21: Investment Summary
Investment Summary 21 C-Scan®: a potential paradigm shift in CRC screening Prep-free screening method for precancerous polyp detectionPatient-friendly and addresses legacy aversion to colonoscopy Significant unmet need in colorectal cancer (CRC) screening ~881,000 deaths and ~1.8M new cases globally
Slide 22: Appendix
te Appendix |
Slide 23: Reimbursement for Screening Methods
Reimbursement for Screening Methods 23 Colonoscopy Medicare $1,2121 (Out of pocket private sector $2,100 – $3,7642)Cologuard (Stool DNA, Exact) $5093Capsule Endoscopy (Medtronic) $763*4 *83,100 JPY in 2014 or $763US (based on Jan 2, 2019 rates).Sources:1. Relates to estimated average cost with biops
Slide 24: X-ray Exposure Control
X-ray Exposure Control 24 mSv Comparison of approximate effective radiation dose in adults for several radiology procedures Very Low Radiation Exposure STANDBY MODE SCAN MODE Source: https://www.radiologyinfo.org/en/info.cfm?pg=safety-xray 0.05 0.1 6 8 10