Check-cap Ltd. · NASDAQ:MBAI
Check-cap — IPO Roadshow (January 2015)
33 slides from Check-cap's IPO roadshow presentation, Jan 26, 2015
Slide 1: Issuer Free Writing Prospectus
Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Registration Statement No. 333-201250 Dated January 23, 2015 (To Preliminary Prospectus dated January 23, 2015) Free Writing Prospectus Check-Cap Ltd. Company Presentation This free writing prospectus relates to the proposed public offering o
Slide 2: Colon 3D imaging capsule for colorectal cancer screening
Colon 3D imaging capsule for colorectal cancer screening Company Presentation January 2015
Slide 3: Disclaimers and Forward-Looking Statements
Disclaimers This presentation highlights basic information about us and the offering. Because it is a summary, it does not contain all of the information you should consider before investing. Check-Cap Ltd. (the “Company”) has filed a registration statement (including a preliminary prospectus) with
Slide 4: Initial Public Offering Summary
Initial Public Offering Summary Issuer • Check-Cap Ltd. Exchange / Ticker • NASDAQ Capital Markets / CHEKU, CHEK, CHEKW Offering Shares Outstanding Over-Allotment Expected Price Range Use of Proceeds Joint Book-Running Managers • Chardan Capital Markets, LLC and Maxim Group LLC Co-Manager • Feltl an
Slide 5: Who We Are
Who We Are $37M Raised* - Rich IP Portfolio - 16 patents 23 patents pending Target Regulatory Clearance - Europe: 2016, U.S. & Japan: 2017 GE, Fosun, Pontifax, Jacobs, Counterpoint, Docor, BXR, Biomedix, others * Including $12M in pending Private Placement Founded - 2005 Located - Carmel, Israel Emp
Slide 6: Our First Product
Our First Product 1 st imaging capsule for colorectal cancer screening Designed for increased compliance No bowel cleansing required
Slide 7: Seasoned Management and Board of Directors
Dr. Yoav Kimchy Founder and Chief Technology Officer Tomer Kariv of Pontifax Venture Partners Guy Neev Chief Executive Officer Dr. Walt Robb Counterpoint Ventures Richard Stone Emigrant Savings Bank Alon Dumanis of Docor International Management Steve Hanley to join post-IPO (March 2015) Yuval Yanai
Slide 8: Colorectal Cancer
Colorectal Cancer “The most preventable, yet least prevented cancer.” New cases current Deaths current Treatment cost EU 471k ** 228k ** U.S. 137k * 50k * World-wide (1) 1.36m ** 694k ** $99b (2) At least 60% of lives could have been saved in the United States with appropriate screening *** *- Ameri
Slide 9: Screening compliance and goal of cancer prevention
Only about 65% of the recommended population in the United States is screened for CRC , * while less than 30% is screened in Europe. Our Goal: Cancer Prevention by Pre-cancerous Polyp Detection 1 2 Stage Stage 93% 78% *- Centers for Disease Control and Prevention Testing Compliance Key Highly Surviv
Slide 10: Patients Are Hesitant to Undergo Screening with Current Methods
Patient are Hesitant to Undergo Screening with the Current Methods ✓ Check-Cap imaging capsule designed to address all these concerns * Source: Mayo Clinic Proc. 2007;82(6):666-671. Figure 1, Most troubling part of colon testing. Responses to the question, “What do you feel is the most troublesome p
Slide 11: Compelling Market Size
291m 343m 635m 10 years Procedures per year 63m (1) Average price per capsule $500 Annual market opportunity $32b (2) Compelling Market Size* (1) Assumes one screening every 10 years. (2) Based on an average selling price of $500. * Source - U.S. Census Bureau; http://www.census.gov/population/inter
Slide 12: Current Screening Modalities
Current Screening Modalities Colonoscopy CTC Optic Capsules Fecal Occult Blood Test Stool DNA P - P P P P P P x x x x P - P - x x - Blood Tests P x Safety Comfort Efficacy * In clinical trials In clinical trials P
Slide 13: Innovative Low-dose X-ray Radar Technology
Innovative Low-dose X-ray Radar Technology Imaging Capsule travels naturally in the GI tract, propelled by peristalsis The capsule is continuously tracked, and transmits data to an external receiver Capsule detects CMT XRF (X-ray Fluorescence radiation) Flux attenuated by the colon contents in direc
Slide 14: Check-Cap Solution - Prep Free CRC Screening
Check-Cap Solution - Designed for Prep Free, Accurate, CRC Screening Video * The Check-Cap system is not available for sale or for any clinical use
Slide 15: Patients Continue with their Daily Routine
Patients Continue with their Daily Routine a disposable patch on lower back CPS During 1-5 days of test patients continue with their normal daily routine Patients are notified by a Check-App interface Capsule designed to travel naturally in the Colon, transmitting Data to CPS Receiver Unit Image for
Slide 16: Clinician Can Review Results in Minutes
Clinician can Review Results in Less than 10 Minutes Image for illustration only Data downloaded from CPS Patch to Check-Cap workstation for analysis: review time * The Check-Cap system is not available for sale or for any clinical use
Slide 17: Clinical Data Generation is On-track and Ongoing
Clinical Data Generation is On-track and Ongoing Germany 40-60 Israel (Netherlands to be launched) Ongoing Proof of Concept Israel FDA Pivotal Trial* 10 U.S. sites 5 EU sites OUS Registry* (post marketing) * Anticipated. Subject to regulatory approval
Slide 18: Polyp Detection - Lab Evidence
Polyp Detection - Lab Evidence 6mm polyp Tissue-equivalent phantom model Preprocessed Surface Data 8mm Polyp in silicon phantom 8mm polyp 7mm polyp 7mm polyp 8mm polyp
Slide 19: Polyp Detection - Pre-Clinical Evidence
10mm polyp 10mm polyp Polyp Detection - Pre-Clinical Evidence 10 mm Polyp in colon Polyp preparation Preprocessed Surface Data 10 mm Polyp preparation in Bovine Colon Phantom Preprocessed Surface Data Bovine Colon Phantom Autonomous capsule in Pig Colon
Slide 20: Polyp Detection - High/Low Capsule Velocity
Normal velocity High velocity Polyp Detection - High/Low Capsule Velocity (Lab) 0.6 mm/s 4.3 mm/s
Slide 21: Polyp Detection - Sensitivity and Specificity
Size / Shape Distinction True Positive vs. False Positive Polyp Detection - Sensitivity and Specificity (Lab) 100% TP 0% FP CMT XRF Fused % FP No polyp Polyp
Slide 22: Unlike an Optical Pill, Check-Cap Tracks the Capsule Route
Unlike an Optical Pill, Check Cap Tracks the Capsule Route in the Colon Actual clinical images
Slide 23: Proof of Imaging Concept - Clinical Study Data
Proof of Imaging Concept - Clinical Study data Colon full of content Clinical images from unprepped human colon
Slide 24: Strong Intellectual Property
Strong Intellectual Property Our granted patents (2010-11) are directed to an ingestible capsule with a radiation source and radiation detectors that, when used in conjunction with a radio opaque contrast agent, is adapted to detect clinically relevant findings in the colon Core patents granted in m
Slide 25: Product Development Roadmap
Product Development Roadmap Tissue Density Imaging Flat Polyp, Cancer Discrimination New system concepts Enhanced Low Cost Electronics & Mechanics Cad Capabilities Miniaturization IQ Enhancement X-Ray imaging Catheters Chronic Sinusitis Imaging & Sinus Drain Intervention Acute Artery Occlusion, Plaq
Slide 26: Target Milestones with a Well-defined Regulatory Pathway
Target Milestones with a Well-defined Regulatory Pathway Anticipated Financing Design Freeze CE Submission H H CE Mark Strategic Discussions EU Registry Pilot Launch 2 nd Pre-IDE Pivotal Protocol Submission Finalize EU Registry 1 st Release FDA Trial Launch Possible Launch in EU* FDA Trial Ongoing R
Slide 27: Summary
✓ ✓ ✓ ✓ ✓ ✓ ✓ Summary Innovative technology with potentially competitive advantage Attractive market opportunity Proof of concept clinically demonstrated Well-defined regulatory pathway Core patents granted in major jurisdictions Seasoned management and advisory teams Established funding history
Slide 28: Appendix
Appendix
Slide 29: Established Funding History
Established Funding History * $12M is kept in escrow pending investment in Private Placement. Terms of Private Placement will be based on IPO price and other terms.
Slide 30: Patent Application Table
Ref Application’ Application Re phate Tite Status Jurisdiction Priority mlication san Status NextStep Renewals sae torres ——-APAATUS ANE METHOS—Greyl——ak_~—~=~=*«NPWPOTRLIOTOS <2 ~~ Guo 7 sono [ooiais WHSHIITAaNeAs APPARATUS AND METHOD Gremsl EP _—_—NPoERCTILZONIOOES 447008 ‘ams Gradve Valdes edi DR
Slide 31: Patent Table
Re PRN Number Tite Status Juisicion Prints APpHCION sup stams NextStep Renewals ‘sui 23g CNERARIATION Feng % eibwa 69am 962m Aare rcs ‘sows? ——sanaig@—«EALEATE RADIATION rn ‘AerGnet ‘sousas miss“ EALEATERADIATION ots «UBS. 1592010 96I0LI Unter Benin a oe eM Fete ——<CA—~=CBHAT S920 SRO) Ahead REO a ‘
Slide 32: Very Low Radiation Exposure
Very Low Radiation Exposure mSv Typical Organ Radiation Doses from Various Radiologic Studies 0.04mSv
Slide 33: Proof of Concept Clinically Proven
Proof of Concept Clinically Proven Professor Nadir Arber, Head of Integrated Cancer Prevention Center Tel Aviv Sourasky Medical Center, Israel “These results underpin the great potential of Check-Cap imaging technology to become a very appealing tool for screening of pre-cancerous polyps and colorec