Check-cap Ltd. · NASDAQ:MBAI
Check-cap — Investor Presentation (September 2019)
25 slides from Check-cap's investor presentation, Sep 6, 2019
Slide 1: Check-Cap: Redefining Colorectal Cancer Prevention
Check-CapRedefining Colorectal Cancer Prevention CORPORATE PRESENTATION September 2019 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 alternative targeted to reduce global CRC incidenceDesigned to address unmet needs in a multibillion-dollar marketCE Mark granted, approved for sale in IsraelPositive clinical data from post-CE approval studyU.S. clinical study underwayGlobal manufacturi
Slide 5: Precancerous Polyp Detection – Key for CRC Prevention
Precancerous Polyp Detection – Key for CRC Prevention 5 ~10 years Prevention Opportunity1 <10 10 - 19 20 - 29 ≥30 Malignancy Rate* Polyp Size (mm) 0% 0.9% 6.1% 38.1% Source:1. https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/detection.html. * Pickhardt et al. Glin. Gatro
Slide 6: Global Screening Rates Remain Low
Global Screening Rates Remain Low Ages ≥50 60% ~ 7% ~ 20-30% ~ 15% Low Rates 2 3 4 Source: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 adults that had a colon
Slide 7: CRC: Third Most Diagnosed, Yet Least Prevented Cancer
CRC: Third Most Diagnosed, Yet Least Prevented Cancer 7 Source:1. http://gco.iarc.fr/today/data/factsheets/cancers/10_8_9-Colorectum-fact-sheet.pdf2. https://gut.bmj.com/content/66/4/683.3. https://progressreport.cancer.gov/after/economic_burden4. https://www.medscape.com/viewarticle/727459 Annual I
Slide 8: Multi-Billion Dollar Market Opportunity
Multi-Billion Dollar Market Opportunity Revised ACS guidelines recommending average risk population to begin screening at age of 45 89M ~$9B 220M ~$20B 348M ~$30B UNITED STATES EUROPE CHINA 8 Screening Population* Market Opportunity** Source:*Population age groups 50-74. United Nations DESA/ Populat
Slide 9: Our Solution: Prep-Free Polyp Detection
C-Scan® View C-Scan® Track C-Scan® Cap The C-Scan® System is not available for sale or clinical use in the U.S. Our Solution: Prep-Free Polyp Detection 9 Natural passageUltra-low dose X-ray scanning technology Autonomous control positioning and recording Post processing suite2D/3D maps of colon’s in
Slide 10: Patient-Friendly Procedure
Patient-Friendly Procedure C-Scan® Track attached to patient’s back No special dietContrast agent + Fiber with each mealProcedure takes 2-3 daysPatient is notified once capsule is excreted naturally Clinical data downloaded from patch to C-Scan® ViewAnalysis and report 10 Normal Daily Routine 1 Phys
Slide 11: C-Scan Advantages
PhysicianImproved adherence - alternative for patients refusing or unable to undergo colonoscopyPotential for increased treatment volumesEnhanced analysis toolNO operating room required C-Scan® Advantages 11 PatientNO bowel preparationNON-invasive procedureNO sedation, pain or discomfortNO interrupt
Slide 12: Clinical Value for CRC Prevention
Clinical Value for CRC Prevention 12 Post CE approval study* results1 for precancerous polyps 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 to col
Slide 13: Post-CE Case Study - Agreement with Colonoscopy
Post-CE Case Study - Agreement with Colonoscopy 13
Slide 14: Advancing Global Positioning
Advancing Global Positioning 14 U.S. Ongoing pilot study GE Healthcare manufacturing line completed Pivotal study initiation planned in 2020Sales and MFG following FDA clearance EUCE Mark grantedPilot sales initiation planned in 2021 Israel Israeli Ministry of Health (“AMAR”) approval obtainedOngoin
Slide 15: Global Manufacturing Footprint
Global Manufacturing Footprint 15 Completion of Manufacturing Line Transfer Implementation and Qualification by GE Healthcare MFG Infrastructure Adhering to Worldwide Regulatory and Safety Standards
Slide 16: Headway to Commercialization
Headway to Commercialization 16 Strategic Suppliers MFG Center Of Excellence Reimbursement Strategy Strategic Partnership Engagements Capacity & Quality Ramp Up
Slide 17: Strong Global Intellectual Property Franchise
Strong Global Intellectual Property Franchise 17 41Granted 22 Pending Core patents granted in major jurisdictions C-Scan Core Patents Future potential applications X-ray capsule medical imaging3D Real-time tracking3D Recon algorithms Drug delivery capsuleMicrobiome sampling capsuleCatheter-based X-r
Slide 18: Management Team
Founder & CTO Management Team 18 Chief Financial Officer Mira Rosenzweig Chief Executive Officer Alex Ovadia VP of Research & Development Boaz Shpigelman VP of Operations Joshua Belkar Yoav Kimchy, Ph.D VP QA&RA Israel Hershko
Slide 19: Board of Directors
Board of Directors 19 Dr. Walt Robb XQ Lin Steve Hanley Chairman Yuval Yanai Clara Ezed Dr. Mary Jo Gorman Member of the BOD of Check-Cap US Inc., our U.S Subsidiary Extensive Experience in Medical Technology Development and Commercialization
Slide 20: Near-Term Major Milestones
Near-Term Major Milestones Positive Final Results from Post CE Approval StudyManufacturing Line at GE ReadyCompletion of U.S. Pilot Study Initiation of U.S. Pivotal Study2,5,6Pilot Sales Initiation in Israel1,2,4 Completion of U.S. Pivotal Study2,5,6File with FDA2,5,6FDA Approval2,5,6Pilot Sales Ini
Slide 21: 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 Prep-free screening method for precancerous polyp detectionPatient-friendly and addresses major barriers to colonoscopyPositive clinical data Globa
Slide 22: Appendix
APPENDIX
Slide 23: 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 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 6 8 10 0.1 0.05
Slide 25: C-Scan: Preparation-Free Colon Screening
C-Scan®: Preparation-Free Colon Screening 25 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