Check-cap Ltd. · NASDAQ:MBAI
Check-cap — IPO Roadshow (April 2018)
27 slides from Check-cap's IPO roadshow presentation, Apr 18, 2018
Slide 1: Corporate Presentation April 2018
Corporate Presentation April 2018 www.check-cap.com
Slide 2: Safe Harbor Statement
This presentation highlights basic information about us. 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 on Form F-1 (including a preliminary prospectus) with the Securities and
Slide 3: Forward-Looking Statements
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 appear in a number of p
Slide 4: Experienced management team
4 Experienced management team Alex Ovadia CEO Dr. Yoav KimchyFounder & CTO Lior ToremCFO Boaz ShpigelmanVP R&D
Slide 5: Our Mission
5 Our Mission Colon cancer prevention through patient friendly screening
Slide 6: Colon Cancer - Screening is Key to Prevention
6 Colon Cancer - Screening is Key to Prevention Low screening adherence Mortality world-wide ~ 700K annuallyPrevention = Detection of Pre-cancerous polyps Our solution - Patient friendly prep-free screening
Slide 7: Colon Cancer Prevention Market Opportunity
7 Incidence Mortality U.S 135k 50k EU 471k 228k China 310k 149k Japan 113k 48k Expected to increase by 60% by 2030 Deaths world-wide ~ 700k Most lives could be saved $42.6B Colon Cancer Prevention Market Opportunity Sources: * - Population age +50 at average risk - United Nations DESA/ Population Di
Slide 8: Pathway to commercialization
8 Pathway to commercialization >200 capsules ingested, clear safety recordISO 13485 Certification and CE mark attainedU.S. clinical pathway realization in planningOngoing manufacturing line buildup at GERequest for marketing approval submitted in Israel Ongoing discussion with strategic partners
Slide 9: Robust Intellectual Property
9 Core patents granted in major jurisdictions Robust Intellectual Property 33 Granted 1 Allowed20 Pending worldwide
Slide 10: Multiple near term inflection points
10 Multiple near term inflection points Post CE approval study interim resultsC-Scan system approved for marketing in Israel Q3/18E Q4/18E Q2/19E Q4/19E IDE approvalManufacturing line at GE readyU.S. Pilot study initiation Post CE approval study final results Sales initiation in Israel (1,2) Sales i
Slide 11: Strong support from KOL's
11 Prof. Seth A. Gross “C-scan is a novel approach to improve colon cancer screening that can become an alternative to current screening methods. The device generates 3D colon mapping without the need for bowl preparation through which it eliminates barriers for screening noncompliance and has poten
Slide 12: Prevention Opportunity
12 ~10 years Prevention Opportunity From healthy individual with pre-cancerous polyps To cancer patient Early Detection Source: Gastro 1997;112:594-692 (Winawer) Cancerous Polyp Highly preventable form of cancer
Slide 13: Screening rates U.S, EU and China
13 Screening rates U.S EU and China Ages ≥ 50 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) Schreuders EH, et al. Gut 2015;0:1–13. doi:10.1136/gutjnl-2014-309086 60% 20-30% U.S
Slide 14: Barriers to Colonoscopy screening in U.S
14 Barriers to Colonoscopy screening in U.S Laxative preparation Insertion of endoscope Fasting requirements Other reasons Concern over pain Embarrassment Source: Mayo Clinic Proc. 2007;82(6):666-671 (Beebe)
Slide 15: Screening methods: adherence vs sensitivity
15 Prevention-Screening for cancer and polypsHigh sensitivity for pre-cancerous polyps Early Detection-Screening for cancer Low sensitivity for pre-cancerous polyps C-Scan focuses on increasing public’s willingness to screen C-Scan® CTC Colonoscopy Capsule Endoscopy FOBT, FIT Stool DNA Liquid Biopsy
Slide 16: C-Scan Advantages
16 C-Scan® Advantages Patient Payer Hospital and Physician NO laxatives NO boostersNO sedation NO need for anesthesiaNO operating roomMinimal staff involved GIs focused on polyp removal Analysis anywhere – Portal based analysis suite INCREASES screening adherenceINCREASES willingness to undergo colo
Slide 17: Correlation between scan imaging density and sensitivity
17 % Sensitivity r2 = 0.98 Scan imaging density Strong correlation between scan imaging density and sensitivity SensitivityAbility to identify polyps accuratelySpecificityAbility to identify lack of polypsScan imaging density Scans distribution along colon Specificity consistent around 89% 44% 55% 7
Slide 18: Financial Overview
18 Financial Overview Amounts raised: $25.5 million IPO with simultaneous private placement in 2015 $11.2 million total registered direct offerings in 2016-20171.6 million shares outstanding (4/4/2018)Trade on the NASDAQ: CHEK $7.0 million of cash, cash equivalents and short-term bank deposits (12/3
Slide 19: Investment Highlights
Investment Highlights Revolution in CRC screening market CE Mark approved in the European Union Strategic collaboration with GE Healthcare Robust intellectual property protection 0344 19 Commercialization pathway buildup Productive discussions with regulatory agencies
Slide 20: Appendix
20 Appendix
Slide 21: Milestones H2 2018E - 2021E
Post EU approval Study FundRaise U.S. Pilot Study Commercialization (Israel) Commercialization (EU) U.S. Pivotal Study Sales (U.S.) Cost Reduction, High Volume Manufacturing 21 2018E 2019E 2020E 2021E Reimbursement Strategic Partner Additional Capital Strategic Partner AMAR* IDE Sufficient Capital M
Slide 22: Reimbursement for screening methods
Reimbursement for screening methods 22 Colonoscopy (avg. including, anesthesia, biopsy, bowel prep) - Medicare $1,036 - Private sector $2,000 to $3,000CTC (Virtual colonoscopy) $436Cologuard (Stool DNA, Exact) $509 Capsule Endoscopy (Medtronic) 83,100 JPY ($776) using current exchange rate for year
Slide 23: X-ray Exposure Control
23 23 X-ray Exposure Control mSv Very Low Radiation Exposure Stand by mode Typical organ radiation doses from various radiologic studies 0.05mSv C-Scan Imaging Scan mode
Slide 24: Clinical development Highlights
24 Clinical development Highlights Israel; 100 patients, 2015 - 2016 Development, Clinical proof-of-concept Safety – ingestion and passage Radiation dosage of 0.06mSv (~chest X-ray) 3D colon map and capsule track Polyp identification validated by colonoscopy Clinical Feasibility Clinical Performance
Slide 25: Potential New applications
25 Potential New applications depending on potential strategic partnerships Exploring opportunities for C-Scan® technology spin offs Localized drug delivery capsuleGastro intestinal motility diagnostics capsuleSmall bowel video capsule combined with C-Scan® tracking system
Slide 26: Executive Management and BOD
26 Executive Management Alex Ovadia CEODr. Yoav KimchyFounder & CTO Lior Torem CFOBoaz ShpigelmanVP R&D BOD Dr. Walt Robb (1)Yuval YanaiDr. Mary Jo GormanXQ LiTomer KarivClara Ezed Member of the BOD of Check -Cap US Inc. our U.S Subsidiary Steve Hanley Chairman
Slide 27: C-Scan - Preparation-Free Colon Screening
27 C-Scan®- Preparation-Free Colon Screening The C-Scan System is not available for sale or clinical use in the US.