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October 2016 NEXT GENERATION CANCER SCREENING MEDICAL

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Page 1: October 2016 - Todos Medicaltodosmedical.com/wp-content/.../03/...2016-FINAL-non-confidential.pdf · Note: Based on Todos ... (FTIR) spectroscopy leveraged to detect changes in immune

October 2016

NEXT

GENERATION

CANCER

SCREENING

MEDICAL

Page 2: October 2016 - Todos Medicaltodosmedical.com/wp-content/.../03/...2016-FINAL-non-confidential.pdf · Note: Based on Todos ... (FTIR) spectroscopy leveraged to detect changes in immune

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

Page 3: October 2016 - Todos Medicaltodosmedical.com/wp-content/.../03/...2016-FINAL-non-confidential.pdf · Note: Based on Todos ... (FTIR) spectroscopy leveraged to detect changes in immune

MEDICAL

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Blood test as first line method and standard of care for cancer screening

OUR VISION

Page 4: October 2016 - Todos Medicaltodosmedical.com/wp-content/.../03/...2016-FINAL-non-confidential.pdf · Note: Based on Todos ... (FTIR) spectroscopy leveraged to detect changes in immune

MEDICAL

4 4

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)

Page 5: October 2016 - Todos Medicaltodosmedical.com/wp-content/.../03/...2016-FINAL-non-confidential.pdf · Note: Based on Todos ... (FTIR) spectroscopy leveraged to detect changes in immune

MEDICAL

5 5

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

Page 6: October 2016 - Todos Medicaltodosmedical.com/wp-content/.../03/...2016-FINAL-non-confidential.pdf · Note: Based on Todos ... (FTIR) spectroscopy leveraged to detect changes in immune

MEDICAL

6 6

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

Page 7: October 2016 - Todos Medicaltodosmedical.com/wp-content/.../03/...2016-FINAL-non-confidential.pdf · Note: Based on Todos ... (FTIR) spectroscopy leveraged to detect changes in immune

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

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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

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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

Page 10: October 2016 - Todos Medicaltodosmedical.com/wp-content/.../03/...2016-FINAL-non-confidential.pdf · Note: Based on Todos ... (FTIR) spectroscopy leveraged to detect changes in immune

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

Page 11: October 2016 - Todos Medicaltodosmedical.com/wp-content/.../03/...2016-FINAL-non-confidential.pdf · Note: Based on Todos ... (FTIR) spectroscopy leveraged to detect changes in immune

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

Page 12: October 2016 - Todos Medicaltodosmedical.com/wp-content/.../03/...2016-FINAL-non-confidential.pdf · Note: Based on Todos ... (FTIR) spectroscopy leveraged to detect changes in immune

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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

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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

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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)

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MEDICAL

15 15 16

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

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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

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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

Page 18: October 2016 - Todos Medicaltodosmedical.com/wp-content/.../03/...2016-FINAL-non-confidential.pdf · Note: Based on Todos ... (FTIR) spectroscopy leveraged to detect changes in immune

MEDICAL

18 18

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

Page 19: October 2016 - Todos Medicaltodosmedical.com/wp-content/.../03/...2016-FINAL-non-confidential.pdf · Note: Based on Todos ... (FTIR) spectroscopy leveraged to detect changes in immune

19

Rami Zigdon CEO

Telephone: +972-54-638-0666 | Fax: +972-8-633-3964

[email protected]

Thank You!

For Additional Information:

NEXT

GENERATION

CANCER

SCREENING

MEDICAL