Check-cap Ltd. · NASDAQ:MBAI
Check-cap — Investor Presentation (July 2015)
26 slides from Check-cap's investor presentation, Jul 21, 2015
Slide 1: 3D Diagnostic Imaging for Colorectal Cancer Screening
3D Diagnostic I maging for Colorectal C ancer S creening Corporate Presentation July 2015
Slide 2: Disclaimers: Forward-Looking Statements
Disclaimers 2 Forward - Looking Statements This 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
Slide 3: Our Mission
Our Mission 3 We are developing the world’s first non - invasive system for cleanse - free imaging of the colon to identify precancerous polyps and cancers. By removing significant barriers to screening and increasing patient acceptance and access to structural colon examinations, our technology enc
Slide 4: About Check-Cap
About Check - Cap 4 Founded – 2005 Located – Israel, Boston Employees – 50 Clinical trials ongoing in Israel/Europe; Plan to initiate U.S. pivotal trial in 2016 Technology consists of imaging capsule, tracking system, processing software Clinical Stage Medical Diagnostics for Colorectal Cancer Nasda
Slide 5: Imaging System
Check - Cap Imaging System 5 • High sensitivity to polyps and cancers • Cleanse - free bowel preparation Designed For: • Patient Acceptability • Affordability • Patient Accessibility • Fast results The Check - Cap Imaging System is not available for sale or for any clinical use in the U.S.
Slide 6: Investment Highlights
Investment Highlights 6 ✓ ✓ ✓ ✓ ✓ ✓ Leading - edge technology Significant market opportunity Experienced management and advisory teams Proof of concept clinically demonstrated Established regulatory and reimbursement pathway Core patents granted in major jurisdictions Investment Highlights 6
Slide 7: Experienced Management and Board of Directors
Experienced Management and Board of Directors 7 Board of Directors Dr. Walt Robb Steve Hanley Yuval Yanai Dr . Mary Jo Gorman Richard Stone Alon Dumanis Tomer Kariv Guy Neev Dr. Yoav Kimchy Executive Team Guy Neev – Chief Executive Officer 14 years of executive management experience. Chief Executive
Slide 8: Colorectal Cancer: A Major Public Health Problem
Colorectal Cancer: A Major Public Health Problem 8 Global treatment costs estimated at $ 99 bn. U.S. treatment costs projected to be $ 20 bn in 2020 . New cases current Deaths current U.S. 137k 50k EU 471k 228k China 253k 139k Japan 113k 48k World - wide 1.36m 694k Source: American Cancer Society Wo
Slide 9: Colorectal Cancer is Highly Preventable
Colorectal Cancer is Highly Preventable 9 From 2001 to 2010 in the U.S., decreases were achieved in colorectal cancer incidence (3.4%/year) and death (~3%/year) Small Adenomatous Polyp (< 1 cm) Cancer ~10 years Colorectal cancer exists in a lengthy precancerous phase where it is readily detectable b
Slide 10: Only 65% of U.S. Adults are Current with Screening Guidelines
Only 65% U.S. Adults are Current with Screening Guidelines 10 Structural 61.7% current compliance Colonoscopy CT Colonography Optical Capsule Enable detection of advanced adenomas and cancer Biomarkers 10.4% current compliance Stool & Stool DNA Blood Enable detection of cancer A literature review of
Slide 11: Barriers to Screening
Barriers to Screening 11 Source : Mayo Clinic Proc. 2007 ; 82 ( 6 ): 666 - 671 (Beebe) Other reasons Embarrassment Concern over pain Fasting requirements Insertion of tube Laxative preparation Standard Colonoscopy CTC Optical Capsule ✓ Check - Cap Imaging System is designed to address all these conc
Slide 12: Compelling Market Opportunity
Compelling Market Opportunity 12 Keys Total Population Total Population 50 - 75 years old 635mn U.S., EU, Japan, China 57 mn/year 2008 ACS /USMSTF/ ACR guidelines for screening with colonoscopy Individuals at medium risk screened once every 10 years $34bn At average Check - Cap Imaging System price
Slide 13: Screening Tests for Colorectal Cancer
Screening Tests for Colorectal Cancer 13 * Detection of advanced adenomas > 50 % Structural Biomarkers Colonoscopy CTC Optic Capsules Fecal Occult Blood Test Stool DNA P - P P P P P P x x x P - P -- x x - Blood Tests P x Efficacy* Risk Comfort In clinical trials P P -
Slide 14: Ultra-Low Dose X-Ray Imaging Capsule
Ultra - Low Dose X - Ray Imaging Capsule 14 Patients drink a small amount of contrast agent with each meal during capsule passage As the capsule moves naturally, it images the inner surface of the colon in a 360 degree circle, only scanning when in motion The capsule is excreted naturally and the pa
Slide 15: Patients Continue with their Daily Routine
Patients Continue with t heir Daily Routine 15 CPS During 1 - 5 days of passage, patients continue with their normal daily routine As the capsule travels, it transmits Data to the Capsule Positioning System , mapping the structure of the colon a disposable patch on lower back Image for illustration
Slide 16: Physician Review in Less than Minutes
Physician Review in Less t han 10 Minutes 16 Data is downloaded from the CPS to the Workstation, which combines the 3 D Surface with the 3 D Path to create a 3 D image of the colon for physician review: 7 mm polyp 8mm polyp Tissue - equivalent phantom model The Check - Cap Imaging System is not avai
Slide 17: Polyp Detection – Sensitivity and Specificity (Lab)
Polyp Detection – Sensitivity and Specificity (Lab) 17 True Positive vs. False Positive 100 % TP 0 % FP CMT XRF Fused % TP % FP Size / Shape Distinction No polyp P olyp Width (mm) Height(mm)
Slide 18: Clinical Data Generation
Clinical Data Generation 18 1 st c linical cases of the Imaging Capsule Motility Trial 60 Germany CE Mark Trial (Preliminary Efficacy) 40 - 60 3 Israel sites 1 EU site Ongoing Proof of Concept 10 Israel FDA Pivotal Trial* 10 U.S. sites 5 EU sites EU Registry* (post marketing) * Anticipated. Subject
Slide 19: CE Mark Trial Accomplishments
CE Mark Trial Accomplishments • Goal is demonstration of Preliminary Efficacy and algorithm/component optimization • Opened 3 rd clinical site in Israel, initiating EU site • Progress towards Preliminary Efficacy – Capability to image • Both pedunculated and sessile polyps • Polyps in various segm
Slide 20: A Case Study of a Polyp Detected in the Ascending Colon
A Case S tudy of a Polyp D etected in the Ascending C olon 20 Images taken during colonoscopy of a a 4 mm sessile polyp on a haustra in the ascending colon A segment of the ascending colon where a polyp was visualized is marked by a dotted blue line A 3 D map of the colon as measured by the capsule
Slide 21: A Case Study of a Polyp Detected in the Sigmoid Colon
A case study of a polyp detected in the sigmoid colon 21 A Case S tudy of a Polyp D etected in the Sigmoid C olon A segment of the sigmoid colon where a polyp was visualized is marked by a dotted blue line Fillet - type reconstruction of the sigmoid colon section. The polyp is clearly visible Tube -
Slide 22: Potential Screening Benefit
Potential Screening Benefit of Check - Cap 22 Source: J Clin Gastroenterol 2014 Jan; 48 ( 1 ): 52 - 4 ( Chatrath ) Survey of 502 patients in a primary care setting: - 62 % had prior colonoscopy, 38 % had not Patients not willing to undergo future colonoscopy (n= 218 ) Patients with preference (n=135
Slide 23: Strong Intellectual Property Position
Strong Intellectual Property Position 23 18 granted, 1 allowed, and 29 pending from major jurisdictions including the U.S . PTO, European Patent Organisation, China, Japan , & India covering the core technology: • Intra - Lumen P olyp Detection – system and method for an ingestible capsule with an X
Slide 24: Target Milestones
Check - Cap Target Milestones 24 All timelines are subject to regulatory approvals 2015 2016 - Initial Public Offering - Demonstrate Preliminary Efficacy - CE Mark Trial Completion - CE Mark Submission - EU Registry Study - C ommercial Launch in EU* - U.S. Pivotal Trial I nitiation * Capital depende
Slide 25: Financial & Corporate Summary
Financial & Corporate Summary 25 Financial position • $ 19 million cash as of June 30 , 2015 • Cash runway through 2016 Capital structure • Traded on the NASDAQ: CHEK • Warrants traded on the NASDAQ: CHEKW • US IPO: February 2015 • 10 . 8 million ordinary shares outstanding • Insider ownership: 31 %
Slide 26: Investment Summary
Investment Summary 26 ✓ ✓ ✓ ✓ ✓ ✓ Leading - edge technology Significant market opportunity Experienced management and advisory teams Proof of concept clinically demonstrated Established regulatory and reimbursement pathway Core patents granted in major jurisdictions Investment Summary 26