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October 2016
NEXT
GENERATION
CANCER
SCREENING
MEDICAL
MEDICAL
2 2
This presentation may contain forward-looking statements, including, without limitation, statements containing the words “believes”, “expects”, “plans”, ”estimates” and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition, performance or achievements of Todos Medical Ltd., or industry results, to be materially different from any future results, financial conditions, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, the audience is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as at the date of this presentation. Todos Medical Ltd. expressly disclaims any obligation to update any such forward-looking statements in this presentation to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless required by law or regulation.
Neither Todos Medical Ltd. nor any of its officers, employees, advisers, or agents makes any representation or warranty, express or implied, as to any matter or as to the truth, accuracy, or completeness of any statement made in this presentation, made in conjunction therewith or in any accompanying materials or made at any time, orally or otherwise, in connection with the matters referred to herein and all liability in respect of any such matter or statements is expressly excluded.
Disclaimer
MEDICAL
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Blood test as first line method and standard of care for cancer screening
OUR VISION
MEDICAL
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Accessible, Innovative Blood Test Technology Platform for Cancer Screening
Investment Highlights
Innovative, blood test based method for cancer screening
Non-invasive, rapid, and lower cost
Large, addressable global market
Relative accessibility of a blood test for cancer screening
Next generation platform technology
Fourier Transform Infra-Red (FTIR) spectroscopic analysis of the immune system‘s response to cancer
High performance
Targeting more than 80% sensitivity and more than 80% specificity1
CE Mark approved3
Facilitates commercialization in Europe and other CE regulated markets
First target indications for screening: breast and colon cancer
Compelling features: accessible, lower cost, early stage cancer screening tool
Scalable, platform technology - Planning additional indications to follow
Strong patent coverage - 3 patents pending covering FTIR diagnostic platform
Go-to-market strategy: High margin, low cost go to market strategy; partners with labs and potentially big pharma; no direct sales
1) Source: Based on four, published peer reviewed publications on Todos Medical’s technology platform 2) CE Mark approved for total biochemical infrared analysis (TBIA)
MEDICAL
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Proven Record for Results Delivery
Experienced Leadership
Todos Medical Ltd.
Rami Zigdon MBA, EENG, BSc CEO, Co-founder
• Over 25 years of R&D, Marketing, Sales and Management experience • Seasoned executive at technology companies • Country Manager, Hitachi Semiconductors, Renesas Technology, & Atmel • Product Manager, Scitex (now Kodak) • CTO, NI Medical: Responsible for FDA filings
Udi Zelig, PhD CTO, Co-founder
• Over 10 years in biomedical engineering R&D • Ben Gurion University and Medical School Instructor • Numerous medical and biophysics publications • PhD, Biomedical Engineering: Ben Gurion University
Uri Sher, CPA CFO
• 20 years of experience • Seasoned counsel to development stage companies • Advisor to a hedge fund focused on private placements for public companies
Todos Medical Singapore
Dr. Joseph Wee Managing Director
• Over 45 years as a Productivity and Business Management Consultant to SMEs, MNCs, Government Linked Companies and Government Agencies.
• Held senior management and directorship positions in over 20 companies, including 3 listed companies.
• Member of Advisory Committees appointed by the Government Agencies
MEDICAL
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Fast
Simple (blood test)
Low cost
Radiation free
Automated results
Robust platform with ability to screen for additional cancer types
Scalable
Driving Innovation at the Lab without Change to Current Physician Practices
Robust Cancer Screening from a Simple Blood Test
MEDICAL
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Standard Blood Draw with Todos Kit
Mononuclear Cells & Plasma Separated
FTIR1 Analysis with Todos Algorithm
Results Reported to Doctor
How it Works
Results from Standard Blood Test Delivered in 3 Hours
Note: Fourier Transform Infra-Red (FTIR) spectroscopic analysis of the immune system‘s response to cancer
MEDICAL
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Overall Market Opportunity
Total available market (TAM) estimated at more than 600M tests a year in 2021
Breast and colorectal cancer screening are initial applications
Additional indications planned to follow, with increasing penetration and adoption
Note: Based on Todos Medical calculations
MEDICAL
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First Line Program in Breast Cancer Screening
Mammography shortfalls in dense breast tissues • Tissue density challenges breast cancer screening
• 50% of women are poorly diagnosed (low sensitivity in BI-RADS 3 & 4)
• Higher prevalence of cancer in dense breasts
• Limited screening in Europe & Asia due to large capital equipment outlays, particularly for 3D mammography and MRI systems
Operator dependent sensitivity
MRIs, 3D mammography, and biopsies resolve issues, but result in costly follow up
Centralized Evaluation with Primary Physician for More Cost-Effective Work up
Low Sensitivity Limited System Availability Costly Follow up
Tissue Density Presents Cost-Efficiency Challenges in Breast Cancer Screening
MEDICAL
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Large Breast Cancer Screening Market
$2.2B Market for Breast Cancer Screening
U.S. E.U.
$1B
64 M2
$1.2B
50 M1
Eligible for Screening
Potential Market
1. American Cancer Society, 2009 Early Prevention & Early Detection Facts and Figures
2. Source: European Commission: 2008 Report, Cancer Screening in the EU
MEDICAL
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First Line Approach in Colorectal Cancer Screening
Colonoscopy – An effective prevention measure, but patient compliance is low • Colonoscopy requires fasting and an invasive procedure
• More than 60% of patients refuse colonoscopy, of which more than 80% adhere to blood test recomendations1
• Low compliance rates hinder early cancer prevention measures
Stool Tests – Relatively poor clinical results for early detection, with patient compliance low • Requires submission of fecal “stool” samples
• Only picks up 46% of precancerous polyps vis-à-vis successful results with colonoscopy intervention
• Fecal test compliance still only 50%2 as the test
Novel Blood Test Feature Sets for Increased Compliance and Prevention
Low Compliance Impedes Early Colon Cancer Prevention Measures
1) BMC Gastroenterology. 2014; 14: 183. 2) Gut 2011. British Society of Gastroenterology
Painful & Invasive Low Compliance Poor Early Detection in Stool
MEDICAL
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Large Colorectal Cancer Screening Market
$4.3B Market for Colorectal Cancer Screening
Eligible for Screening
Potential Market
$2B
U.S. E.U.
107 M2
$2.3B
94 M1
2. Source: European Commission: 2008 Report, Cancer Screening in the EU
1. American Cancer Society, 2009 Early Prevention & Early Detection Facts and Figures
MEDICAL
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FTIR Analysis of Chemical Composition of Plasma and PBMCs
Todos Medical Platform Solution
Immune response to tumors and cancer cells APCs, T cells, and B cells actively respond to cancer, resulting in biochemical changes
FTIR advancements facilitate distinction in biochemical compositions Fourier Transform Infra-Red (FTIR) spectroscopy leveraged to detect changes in immune system response to cancer
Differences in spectra of plasma and peripheral blood mononuclear cells (PBMCs) distinguish benign from malignant and healthy
FTIR allows observation of general immune response to distinct cancers Rather than looking for the tumor circulating cells or other markers in the blood
Plasma & PBMC Analysis with FTIR for Simple, Automated, Cost Effective Cancer Screening
MEDICAL
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Analysis of total biochemical changes of Plasma and PBMCs Quantity and conformation of the macro-molecules characterized
Biochemically distinct differences in cancer vs. healthy controls
Breast, colon, and other cancer types produce distinct biochemical changes
Over 1,000 clinical samples contribute to proprietary algorithms
Three patents pending
Todos Medical Platform Solution
Immune Response Acts as Body’s Sensor for Cancer
Beyer M and Schultze JL (2006)
MEDICAL
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Todos Medical Platform Solution
Clinical Results Show High Sensitivity & Specificity
Bre
ast
Can
cer
Scre
en
ing
Lig
ht
ab
so
rpti
on
1100 1080 1060 1040 1020 1000 980 960
-3.0x10-5
-2.0x10-5
-1.0x10-5
0.0
1.0x10-5
2.0x10-5
Wavenumber (cm-1)
Healthy
Benign
CRCCo
lon
Can
cer
Scre
en
ing
Lig
ht
ab
so
rpti
on
Light frequency
Light frequency
MEDICAL
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Publications on Clinical Results
Clinical Support for Feasibility in Breast and Colorectal Cancer Screening
Four Peer Reviewed Publications
Over 80% sensitivity and over 80% specificity achieved in most recent studies
• June 2015, Colorectal Cancer Screening: Barlev et al. Journal of Gastroenterology
• May 2015, Breast Cancer Screening: Zelig et al. BMC Cancer
• February 2013, Proof of concept for solid tumors: Ostrovsky et al. IEEE Transactions on Biomedical Engineering
• November 2005, Leukemia trial publication: Sahu et al. Journal of Leukemia Research
MEDICAL
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Europe(+ Israel) Singapore + Asia Plans for the US
CE Mark approved for European sales
For commercialization in Europe and other CE regulated markets
Breast cancer clinical trials in Singapore; colon cancer to follow
Planning and Pre-IDE meetings with the FDA
IDE filing and initiation of regulatory approval process
Large scale FDA clinical trials
Global Regulatory Plan
Multi-Pronged Development Plan
2016 Year to date Activities:
• Established a subsidiary in Singapore
• Signed a contract with Innovative Labs (Singapore)
• Signed a contract with CGH Hospital (Singapore)
• Started the first part of the trial with CGH
MEDICAL
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Accessible, Innovative Blood Test Technology Platform for Cancer Screening
Investment Conclusion
1) Source: Based on four, published peer reviewed publications on Todos Medical’s technology platform 2) CE Mark approved for total biochemical infrared analysis (TBIA)
Innovative, blood test based method for cancer screening
Non-invasive, rapid, and lower cost
Large, addressable global market
Relative accessibility of a blood test for cancer screening
Next generation platform technology
Fourier Transform Infra-Red (FTIR) spectroscopic analysis of the immune system‘s response to cancer
High performance
Targeting more than 80% sensitivity and more than 80% specificity1
CE Mark approved3
Facilitates commercialization in Europe and other CE regulated markets
First target indications for screening: breast and colon cancer
Compelling features: accessible, lower cost, early stage cancer screening tool
Scalable, platform technology - Planning additional indications to follow
Strong patent coverage - 3 patents pending covering FTIR diagnostic platform
Go-to-market strategy: High margin, low cost go to market strategy; partners with labs and potentially big pharma; no direct sales
19
Rami Zigdon CEO
Telephone: +972-54-638-0666 | Fax: +972-8-633-3964
Thank You!
For Additional Information:
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GENERATION
CANCER
SCREENING
MEDICAL