Check-cap Ltd. · NASDAQ:MBAI
Check-cap — Investor Presentation (October 2017)
27 slides from Check-cap's investor presentation, Oct 10, 2017
Slide 1: Corporate Presentation October 2017
Corporate Presentation October 2017 *
Slide 2: Safe Harbor Statement
Safe Harborstatement 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 app
Slide 3: Our Mission
Our Mission 3 Provide A New Vision for Colorectal Cancer Prevention That improves the patient experience and maximizes the number screened
Slide 4: About Check-Cap
C-Scan® system designed to meet CRC screening needs of average-risk populationIngestible capsule-based system with innovative X-ray technology eliminates screening barriers, such as bowel preparation, invasiveness, and sedation AboutCheck-Cap 4 CRCPrevention (pre-cancerous polyp detection) Patient c
Slide 5: C-Scan System
C-Scan®System C-Scan® Cap -Ingestible scanning capsule 1 C-Scan® Track - Biocompatible unit worn on patient's back for capsule control, tracking and data recording 2 C-Scan® View –application used to process and display structural information 3 Imaging Data + Positioning Data Data upload The Check-C
Slide 6: Investment Highlights
Investment Highlights Compelling, large market need for a preparation free alternative that fosters compliance with colorectal cancer screening guidelinesEncouraging C-Scan clinical performance data supporting CE Mark registration filingNear term EU & US market activities: 1H18 EU post market and US
Slide 7: Management
Management 7 Dr. Yoav KimchyFounder & CTO Alex Ovadia COO Dr. Walt Robb(1) Steve Hanley Yuval Yanai Dr. Mary Jo Gorman XQ LinTomer Kariv Clara Ezed Bill Densel CEO Lior Torem CFO BOD (1) Check-Cap US Inc.
Slide 8: Colorectal Cancer a major public health problem
Colorectal Cancer a major public health problem 8 137k50k Source: American Cancer Society World Health Organization J Natl Cancer Inst. 2011; 103:1-12 (Mariotto) 135k50k 471k228k 253k139k 113k48k 1.36m694k Annual new cases world-wide -Annual deaths world-wide - Second leading cause of cancer deaths
Slide 9: Colorectal Cancer highly preventable
Colorectal Cancer highly preventable 9 Source: Gastro 1997;112:594-692 (Winawer) WEO Atlas, NCI Small Adenomatous Polyp (< 1cm) Colorectal Cancer Pre-cancerous phase, readily detectable by structural examinations of the colon Asymptomatic patient Cancer patient ~10 years
Slide 10: National Polyp Study: CRC incidence and mortality reduction
* National Polyp Study:CRC incidence and mortality reduction Source: Winawer et al., NEJM (1993) Zauber et al., NEJM, 2012 number of CRC cases over 7 years
Slide 11: CRC screening tests: cancer prevention and cancer detection
Source: AGA Institute Guidelines for the Early Detection of Colorectal Cancer and Adenomatous Polyps American Cancer Society. Colorectal Cancer Facts & Figures 2017-2019. Atlanta: American Cancer Society; 2017 USPSTF, JAMA. 2016;315(23):2564-2575. doi:10.1001/jama.2016.5989 CRC screening testscancer
Slide 12: Screening in the U.S. and EU a substantially underused strategy
Screening in the U.S. and EUa substantially underused strategy 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) goal Screening rates Ages ≥ 50 EU U.S. *
Slide 13: Removal of prep may increase screening rates
Removal of prepmay increase screening rates 13 86% of respondents would be much or somewhat more likely to undergo screening if laxative prep were to be removed. Source: Mayo Clinic Proc. 2007;82(6):666-671 (Beebe) Laxative preparation Fasting requirements Other reasons Concern over pain Embarrassme
Slide 14: Compelling market opportunity
Compelling market opportunity 14 $4B annual U. S. market opportunity** Source: * - population between ages 50-84 at average risk, U.S. Census Bureau, Pop. Division, 2014, company estimates ** - For patients screened once every 5 years at average Check-Cap System price of $600 J Clin Gastroenterol 20
Slide 15: Ultra-low dose X-ray scanning capsule
Ultra-low dose X-ray scanning capsule 15 Patented technology detects photons XRF CMT from Compton Back-scattering and X-Ray Fluorescence As the capsule moves naturally, it scans the inner lining of the colon in a 360 degree arc, scanning only when in motion Patients drink a small amount of contrast
Slide 16: Patients continue their daily routine
Patientscontinue their daily routine 16 As C-Scan® Cap travels naturally, it transmits scanning and location data to the C-Scan® Track, mapping the structures of the internal colon. The capsule is excreted naturally and the patient is notified. Capsule route in colon C-Scan® Track Image for illustra
Slide 17: Physician review of clinical images
Physician reviewof clinical images 17 Images for illustration only
Slide 18: Intellectual Property robust portfolio
Intellectual Property robust portfolio 18 Core patents granted in major jurisdictions 30 granted, 2 allowed, and 27 pending worldwide including the U.S. PTO, European Patent Organization, China, Japan, & India covering the core technology: Intra-Lumen Polyp Detection – system and method for an inges
Slide 19: Clinical development
Clinical development 19 Source: Gut. 2016 Mar;65(3):371-3 (Gluck) Capsule Motility Evaluation of natural movement of capsule Safety – capsule swallow and passage Normal motility Germany/Israel; 75 patients, 2010 Development, Clinical proof-of-concept Safety – capsule swallow and passage Radiation do
Slide 20: Clinical Performance Study
* Clinical Performance Study Study parameters Device technology C-Scan system Objectives SafetyClinical performance of preparation-free C-Scan system detection of patients with polyps Subjects 66 patients enrolled 43 with un-resected polyps23 average-risk Site locations Israel (3 sites) Procedures 6
Slide 21: Clinical Performance Study Results: Safety
Clinical Performance StudyResults 52 ± 32 hours average transit time with no change in routine or diet0.05 mSv average radiation dosageNo device related serious adverse eventsMinor anticipated adverse events * Safety √ √ √ √
Slide 22: Clinical Performance Study Results
Clinical Performance StudyResults All analyzed subjects (45) >50% (19) Sensitivity & Specificity 44% * Colon Coverage >20% (35) >70% (12) 55% 78% 100% r2 = 0.98 89% 89% 90% 86% Clinical PerformanceStrong correlation between scanning coverage and polyp detection
Slide 23: Advanced C-Scan Version: short-term development and clinical objectives
Advanced C-Scan VersionShort-term development and clinical objectives Continue clinical & system optimization program to achieve consistently high colon scanning coverageAdvanced C-Scan version underway in clinical evaluationH118: EU post-market study initiationH118: US Pilot study initiationEvaluat
Slide 24: Development milestones
Developmentmilestones * Capital and strategic partner dependent Initiate clinical study for CE Marking - safety and clinical performance CE Mark submission U.S. Pilot Trial H117 H217 U.S. Pivotal Trial initiation - safety and effectiveness OUS Post Market Study EU launch* H118 H218 √ √ * H119
Slide 25: Financial profile
Financial profile 25 Amounts raised: $25.5 million IPO with simultaneous private placement in 2015; $8.7 million total registered direct offerings in 2016-201717.0 million shares outstanding (6/30/17)$31M market cap (9/30/17)Trade on the NASDAQ: CHEKSeries A warrants trade on the NASDAQ: CHEKW$9.2 m
Slide 26: Investment Highlights
Investment Highlights Compelling, large market need for a preparation free alternative that fosters compliance with colorectal cancer screening guidelinesEncouraging C-Scan clinical performance data supporting CE Mark registration filingNear term EU & US market activities: 1H18 EU post market and US
Slide 27: A New Vision For Colorectal Cancer Prevention
A New Vision For Colorectal Cancer Prevention *