Check-cap Ltd. · NASDAQ:MBAI
Check-cap — Investor Presentation (August 2020)
26 slides from Check-cap's investor presentation, Aug 26, 2020
Slide 1: Redefining Colorectal Cancer Screening & Prevention
Check-CapRedefining Colorectal Cancer Screening & Prevention CORPORATE PRESENTATION August 2020 check-cap.com NASDAQ : CHEK
Slide 2: Safe Harbor Statement
Safe Harbor Statement 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 filin
Slide 3: The Check-Cap Mission
3 The Check-Cap Mission Prevent Colorectal Cancer through Precancerous Polyp Detection
Slide 4: Check-Cap at a Glance
Check-Cap at a Glance Prep-free capsule-based screening option for the health-conscious population and those that currently avoid other screening procedures Target to improve global screening adherence and detection of polyps before they may turn into cancerDesigned to address unmet needs in a multi
Slide 5: Why wait for cancer?
Source:1. Can Colorectal Polyps and Cancer Be Found Early? American Cancer Society.2. Pickhardt et al. Glin. Gatro. And Hep. 2010; 8; 610 Why wait for cancer? ~ 0.5% present cancerous polyps ~ 75%present No polyps ~ 25%present benign polyps Average risk population ages 50-75 0% 0.9% 6.1% Crucial Pre
Slide 6: CRC: Third Most Diagnosed, Yet Least Prevented Cancer
CRC: Third Most Diagnosed, Yet Least Prevented Cancer 6 Source:1. World Health Organization GLOBOCAN database. Accessed in January 20202. Arnold M, et al. Gut 2017;66:683–691. 3. American Society of Cancer. Cancer Facts and Figures 20204. National Cancer Institute. Cancer Trends Progress Report. Acc
Slide 7: Screening Rates - Global Unmet Need
Screening Rates - Global Unmet Need Source:1. Relates to ages 50 years and older, as of 2015. For colonoscopy, this includes adults that had a colonoscopy in the past 10 years or sigmoidoscopy in the past 5 years. For FIT this includes adults that had FIT or FOBT in the past year. https://www.cancer
Slide 8: Multi-Billion Dollar Market Opportunity
Multi-Billion Dollar Market Opportunity Revised ACS guidelines recommending average risk population to begin screening earlier, at age of 45 95M ~$9B 231M ~$23B 419M ~$41B UNITED STATES EUROPE CHINA 8 Potential Population For Screening* Market Opportunity** Source:*Population age groups 50-74. Unite
Slide 9: Our Solution: Prep-Free Polyp Detection
C-Scan® is not available for sale or clinical use in the U.S. Our Solution: Prep-Free Polyp Detection 9 First and only patient-friendly preparation-free test to detect polyps before they may transform into cancerPotential to help millions of busy, active people stay healthy through preventive polyp
Slide 10: Capsule Based C-Scan System
C-Scan® View C-Scan® Track C-Scan® Cap C-Scan® is not available for sale or clinical use in the U.S. Capsule Based C-Scan® system 10 Natural passageUltra-low dose X-ray scanning technology Autonomous control positioning and recording Cloud based analysis suiteMaps of colon’s inner surface
Slide 11: Polyp Presence Confirmed by Colonoscopy
Polyp Presence Confirmed by Colonoscopy Slice profiles 3D map of colon inner surface 11 Sessile polyps C-Scan polyp presence detection analysis tools Colonoscopy findings + images Height map of colon inner surface Single sessile polyp Single polyp Polyp size measured by Colonoscopy 5-10mm 10-20 mm 2
Slide 12: C-Scan: A Prep-Free Patient-Friendly Test
C-Scan: A Prep-Free Patient-Friendly Test Capsule ingestionC-Scan® Track attached to patient’s back No special dietContrast agent + fiber with each mealTest takes 2-3 daysPatient is notified once capsule is excreted naturally Clinical data downloaded from Track to C-Scan® View cloudPre - Analysis an
Slide 13: C-Scan Advantages
PhysicianPotential for improved adherence - alternative for patients refusing or unable to undergo colonoscopyPotential for increased treatment volumesCloud-based analysis toolNO operating room required to perform the screening C-Scan® Advantages 13 PatientOpportunity for preventive polyp screening
Slide 14: Clinical Evidence of C-Scan Performance
Clinical Evidence of C-Scan ® Performance 14 Post CE approval study* results1 for precancerous polyp detection 76% Sensitivity** 82% Specificity *90 patients evaluated of 142 enrolled, evaluation was obtained implementing a gender-based motility analysis. Results of both C-Scan and FIT were compared
Slide 15: U.S. Pilot Study Demonstrating Safety and Patient Satisfaction
Agreement between C-Scan and colonoscopy in detection of polyps for evaluable patients was consistent with data from the post-CE approval study2,3 U.S. Pilot Study Demonstrating Safety and Patient Satisfaction 15 Source:1. Prepless Colon Capsule Technology: New Research Examines This Less Invasive A
Slide 16: Operations Ramp Up
Operations Ramp Up 16 Enhancing infrastructure including investments in manufacturing equipment and personnelBuilding out global supply chainHot line assembly of C-Scan for U.S. pivotal trial being conducted in collaboration with GE HealthcareOngoing evaluation of post-pivotal trial manufacturing sc
Slide 17: Global Regulatory Pathway
Global Regulatory Pathway 17 Pivotal study initiation planned in 2021* *Assuming the COVID-19 pandemic does not cause further interruptions in the Company's operations Israeli Ministry of Health (“AMAR”) approval obtainedOngoing additional clinical data collection Israel EU CE Mark granted United St
Slide 18: Strong Global Intellectual Property Franchise
Strong Global Intellectual Property Franchise 18 42Granted 3Allowed 15Pending Core patents granted in major jurisdictions C-Scan Core Patents X-ray capsule medical imaging3D Real-time tracking3D Recon algorithms Future potential applications Drug delivery capsuleMicrobiome sampling capsuleCatheter-b
Slide 19: Management Team
Management Team 19 Boaz Shpigelman Chief Executive Officer Alex Ovadia VP of Operations Joshua Belkar Founder & CTO Yoav Kimchy, Ph.D. Chief Financial Officer Mira Rosenzweig VP of Clinical Affairs Vardit Segal, Ph.D. VP of Research & Development VP QA&RA Israel Hershko Director of Human Resources N
Slide 20: Board of Directors
Board of Directors Extensive Experience in Medical Technology Development and Commercialization XQ Lin Clara Ezed Steve Hanley Chairman Dr. Mary Jo Gorman Yuval Yanai
Slide 21: Strategic Path Forward
Strategic Path Forward IDE submission Initiation of U.S. Pivotal Study1,2,3 Completion of U.S. Pivotal Study1,2,3File with FDA1,2,3FDA Approval1,2,3 2021E 2022E-2023E 21 Pending sufficient capitalAssuming de novo classification, no PMA and no additional clinical studies requiredPending successful re
Slide 22: Investment Summary
Significant Market Potential ~881,000 CRC deaths ~1.8M new cases of CRC globally in 2018Multibillion-dollar addressable market C-Scan® Value Proposition Preparation-free test to detect polyps before they may transform into cancerOpportunity for patients to take control of their health through preven
Slide 23: Appendix
APPENDIX
Slide 24: Reimbursement for Screening Methods
United States Colonoscopy Out of pocket private sector $1,2121 ($2,100 – $3,7642) Cologuard(Stool DNA, Exact) $5093 Reimbursement for Screening Methods Source:1. Relates to estimated average cost with biopsies in 2015 https://link.springer.com/article/10.1007/s00261-015-0538-1 2. https://aspe.hhs.go
Slide 25: X-Ray Exposure Control
X-Ray Exposure Control 25 mSv Comparison of approximate effective radiation dose in adults for several radiology procedures Very Low Radiation ExposureProximity of the capsule to the scanning target allows for the use of an ultra-low dose radiation Low Environmental ImpactSource half lifetime 15.4 d
Slide 26: C-Scan: Preparation-Free Colon Screening
C-Scan®: Preparation-Free Colon Screening 26 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