Slide 1: A New Vision for Colorectal Cancer Prevention
A New Vision for Colorectal Cancer Prevention Corporate Presentation October 2015
Slide 2: Disclaimers
Disclaimers ForwarceLooking Statements This presentation contains certain statements that may be deemedtobe “forward looking statements’ within the meaning of Section 27A of the Secutities Act and Section 21E ofthe Securities Exchange Act of 1934, as amended. Forward ooking statements appearin a num
Slide 3: Our Mission
Our Mission We are developing the world’s first diagnostic system for cleanse-free examination of the colon to identify precancerous polyps and cancers. By removing significant patient-related and logistical barriers to screening, our technology encourages early polyp detection and colorectal cancer
Slide 4: About Check-Cap
About Check-Cap Clinical trials ongoing in Israel/Europe; Plan to initiate U.S. pivotal trial in 2016 Technology consists of ingestible X-ray scanning capsule, tracking system, processing software GE, Fosun Pharma, Pontifax, Counterpoint Founded - 2005 Located - Israel, Boston Employees - 57 Nasdaq:
Slide 5: The Check-Cap System
The Check-Cap System • High sensitivity to polyps and cancers • Cleanse-free colon scanning Designed For: • Patient Acceptability • Affordability • Patient Accessibility • Fast results The Check-Cap System is not available for sale or for any clinical use in the U.S.
Slide 6: Investment Highlights
Investment Highlights Clear strategy Leading-edge technology Extensive expertise within management and advisory teams Proof of concept clinically demonstrated Established regulatory and reimbursement pathway Robust IP portfolio Significant market opportunity
Slide 7: Experienced Management and Board of Directors
Experienced Management and Board of Directors Dr. Walt Robb Steve Hanley Yuval Yanai Dr. Mary Jo Gorman Richard Stone Alon Dumanis XQ Lin Tomer Kariv Bill Densel Dr. Yoav Kimchy Dr. Board of Directors Executive Team Bill Densel - Chief Executive Officer 23 years of healthcare industry experience, in
Slide 8: Colorectal Cancer: A Major Public Health Problem
Colorectal Cancer: A Major Public Health Problem New cases current Deaths current U.S. 137k 50k EU 471k 228k China 253k 139k Japan 113k 48k World-wide 1.36m 694k Global treatment costs estimated at $99bn. U.S. treatment costs projected to be $20bn in 2020. Source: American Cancer Society World Healt
Slide 9: Colorectal Cancer is Highly Preventable
Colorectal Cancer is Highly Preventable ~10 years 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 (< 1cm) Cancer Colorectal cancer exists in a lengthy precancerous phase where it is readily detectable by s
Slide 10: Only 65% U.S. Adults are Current with Screening Guidelines
Only 65% U.S. Adults are Current with Screening Guidelines 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 Enable detection of cancer Source: CDC. BRFSS Survey Data 20
Slide 11: Barriers to Screening
Barriers to Screening ✓ The Check-Cap System is designed to address all of these concerns Source: Mayo Clinic Proc. 2007;82(6):666-671 (Beebe) Standard Colonoscopy CTC Optical Capsule 32% 21% 15% 13% 11% 8% P P P P P P “We found that the laxative preparation represents…a formidable barrier to screen
Slide 12: Compelling Market Opportunity
Compelling Market Opportunity Keys Total Population Total Population 50-75 years old 635mn U.S., EU, Japan, China 57mn/year 2008 ACS/USMSTF/ACR guidelines for screening with colonoscopy Individuals at medium risk screened once every 10 years $34bn At average Check-Cap System price of $600 Annual mar
Slide 13: Patients drink a small amount of contrast agent with each meal
Patients drink a small amount of contrast agent with each meal during capsule passage The capsule is excreted naturally and the patient is notified Increased CMT = Decreased distance to colon surface Increased XRF = Increased distance to colon surface CMT (X-ray Fluorescence) The Check-Cap System is
Slide 14: Patients Continue with their Daily Routine
Patients Continue with their Daily Routine CPS During 1-5 days of passage, patients continue with their normal daily routine As the capsule travels naturally, it transmits Scanning and Location Data to the Capsule Positioning System , mapping the structures of the internal colon Image for illustrati
Slide 15: Physician Review in Less than Minutes
Physician Review in Less than 10 Minutes Data is downloaded from the CPS to the Workstation, which combines the 3D Surface with the 3D Path to create a 3D image of the colon for physician review The Check-Cap System is not available for sale or for any clinical use in the U.S. Image for illustration
Slide 16: System Performance - Sensitivity and Specificity (Lab)
System Performance - Sensitivity and Specificity (Lab) True Positive vs. False Positive Size / Shape Distinction Polyp 100% TP 0% FP CMT XRF Fused % FP No polyp Height(mm)
Slide 17: Clinical Data Generation
Clinical Data Generation 1 st clinical scanning capsule • Safety • Dynamic Sensing Germany Preliminary Efficacy • Image polyps of various: • Size • Shape • Location • Image polyps in varying contrast concentrations • Image polyps in a range of speed of capsule movement • Creation of clinical atlas 6
Slide 18: A Case Study of a Polyp Detected in the Sigmoid Colon
A Case Study of a Polyp Detected in the Sigmoid Colon 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-type reconstruction of the sigmoid colon section. The polyp is
Slide 19: A Case Study of a Polyp Detected in the Ascending Colon
A Case Study of a Polyp Detected in the Ascending Colon Images taken during colonoscopy of a 4mm 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 Fillet-type reconstruction of the ascending colon section.
Slide 20: Potential Screening Benefit of Check-Cap
Potential Screening Benefit of Check-Cap 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
Slide 21: Robust Intellectual Property Portfolio
Robust Intellectual Property Portfolio 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 Polyp Detection - system and method for an ingestible capsule with an X-ray so
Slide 22: Target Milestones
Target Milestones - Initial Public Offering - Demonstrate Preliminary Efficacy - CE Mark Clinical Evaluation Completed - CE Mark Submission - EU Registry Study - Commercial Launch in EU* - U.S. Pivotal Trial Initiation - Preliminary Efficacy Trial ongoing - Imaging of polyps and creation of clinical
Slide 23: Financial & Corporate Summary
Financial & Corporate Summary Financial position • $16.5 million cash as of September 30, 2015 • Cash runway through 2016 Capital structure • US IPO: February 2015 • Traded on the NASDAQ: CHEK • Warrants traded on the NASDAQ: CHEKW • 10.8 million ordinary shares outstanding • Insider ownership: 31%
Slide 24: Investment Highlights
Investment Highlights Clear strategy Leading-edge technology Extensive expertise within management and advisory teams Proof of concept clinically demonstrated Established regulatory and reimbursement pathway Robust IP portfolio Significant market opportunity
Slide 25: A New Vision for Colorectal Cancer Prevention
A New Vision for Colorectal Cancer Prevention Corporate Presentation October 2015