Q1/2018 Non Confidential Investor Presentation - Todos Medical

 
Q1/2018 Non Confidential Investor Presentation - Todos Medical
Non Confidential Investor Presentation

              Q1/2018
Q1/2018 Non Confidential Investor Presentation - Todos Medical
Safe Harbor
     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.

                                                                                                           2
Todos Medical (OTCQB: TOMDF)
Q1/2018 Non Confidential Investor Presentation - Todos Medical
TODOS Medical Company Vision

 Creating a better and more affordable way of cancer
 screening to improve treatment and reduce mortality.

                                                        3
Q1/2018 Non Confidential Investor Presentation - Todos Medical
Company Mission

•   Blood test as first line method and standard of care for cancer screening.
•   Provide a simple and reliable cancer screening methods based on a blood sample.

                     The Need                                              The Vision
    There is currently no low cost and simple cancer      Todos Medical aims to develop and bring to market
    detection method for many of the main cancers. The    its revolutionary blood tests for cancer detection.
    existing screening methods have at least one of the   Our new cancer test will add a layer to currently
    following significant drawbacks:                      available cancer screening and diagnostics. Our
    • Expensive                                           goal is to help save lives through early detection
    • Low sensitivity or specificity                      while being minimally invasive to the patient.
    • Not comfortable for use (low compliance)
    • Not accessible to the mass population                • Todos Medical’s vision is to become the
    • Requires specialists for interpreting the results      standard of care in the way people are
    • Risk involved (Radiation, Invasive tests…)             routinely checked for cancer (early detection).
    Many people who need to be checked regularly for
    cancer skip the check due to price, availability or    • The new method is easy to implement and at a
    comfort.                                                 low cost, currently targeting the mass
                                                             population as the first choice for cancer
                                                             detection.

                                                           • The technology is a platform, and we are
                                                             investigating methods for using our platform
                                                             on other types of cancers (as a start we are
                                                             focused on breast and colon cancers).
                                                                                                                4
                                                                                                                4
Q1/2018 Non Confidential Investor Presentation - Todos Medical
Executive Summary

TODOS Medical has developed a new cancer detection method that we believe will change the way cancers will be screened
in the future. The method is low cost with high specificity and sensitivity. It is based on optical/biochemical inspection of blood
components. Only 10cc of peripheral blood is needed to run the test. The method is based on optical measurement of the
blood sample and computerized analysis. Our method provide a way for early detection of cancer hence saving lives and
reducing the payers costs.

Customers: Health Insurance companies, Private Clinique - Labs and Governments.
Milestones:
•   We have got CE mark for sales in Europe.
•   Run large scale validation trials
•   Start evaluating FDA approval process
•   Commercialize our method (first sales planned for the mid 2019)
•   Find commercial and strategic partners in Europe, Israel, North America and far east
•   First sales for Breast cancer (TB) in Europe and the far east

TODOS Medical was founded on April 2010. Ben Gurion University (BGU) and Soroka Medical Center located in Israel
developed the core technology which serves as the foundation of this venture. TODOS Medical has the worldwide exclusive
rights on this technology. Three patents granted and more pending.

                                                                                                                                  5
Q1/2018 Non Confidential Investor Presentation - Todos Medical
Investment Highlights

                         Innovation:
                     Blood test based
    Platform:                                Strong IP
                         on the total
   Scalable and                 Scalable     Portfolio:
                        biochemical
     easy to                                 3 patents
                     infra-red analysis
                                Platform
  implement for                             granted and
                       of the immune
 new indications                            more pending
                         system and
                           plasma

Global Presence:          Scientific
Singapore office                             Regulatory
                        publications:
and partnerships                                path:
                          results of
 in Germany &                               CE approved,
                      clinical trials for
developing new                              CLIA and FDA
                         breast and
ones in Asia and                              pathways
                      colorectal tests
 North America

    MEDICAL
Q1/2018 Non Confidential Investor Presentation - Todos Medical
Our Value Proposition

A robust cancer screening from a simple blood test that utilizes
Total Biochemical Infrared Analysis (TBIA): in-vitro diagnostic
method (IVD) based on spectral analysis of peripheral blood
components
 –   Quick
 – Simple (blood test)
 – Non invasive & radiation free
 – Automated results
 – Robust platform with ability to screen for additional cancer types
 – IP Coverage: 3 granted, more pending patents
 – Previous clinical trials present promising results with high accuracy
 – CE mark and ISO 13485 approved; U.S. regulatory process in-progress

                                                                           7
Q1/2018 Non Confidential Investor Presentation - Todos Medical
Company Products

    Todos Breast Screens                            Todos Colon Screen
      TM-B1 & TM-B2                                       TM-C1
Our breast cancer blood Test is targeting a     Colonoscopy is the current standard in
large population of women that need to be       Colorectal Cancer (CRC) testing. Our
checked regularly for breast cancer, whether    proprietary TM-C1 cancer test is targeting the
that is because of a high risk group or at an   detection of colorectal cancers at an early
age that women are routinely screened.          stage. A large percentage (40% or higher) of
Usually all women above 40 years old            patients who have been recommended to
undergo a breast testing. The                   undergo a colonoscopy do not get one
recommended testing protocol using              (mainly due to discomfort and cost). Our TM-
Mammography and Ultrasound have their           C1 test is a groundbreaking cancer test that
limitations and discomfort. Our proprietary
                                                will indicate the presence of colon cancer. As
TM-B1 cancer test will support current
                                                it is a blood test, it is minimally invasive and
cancer diagnostic protocols in their weak
points (like dense breast tissue and young      affordable. If colon cancer is detected, the
woman) and give a simple and low-cost           physician can then determine appropriate
solution for early detection. Our proprietary   next steps. TM-C1 is not intended to replace
TM-B2 cancer screen will allow health care      colonoscopies or other standard diagnostic
providers to distinguish between benign and     methods. Our goal is to incorporate our TM-
malignant breast tumors.                        C1 test into the current colon cancer
                                                screening protocols in order to save lives by
                                                improving early detection.

                                                                                                   8
Q1/2018 Non Confidential Investor Presentation - Todos Medical
Leadership

                                      • Vice President of Medical Affairs and Clinical Development at Juniper Pharmaceuticals in Boston, MA since 2016.
                                      • Senior Director of Clinical Development for Women's Health and Global Head of Women's Health Medical Affairs
                                        at Teva Pharmaceuticals.
Dr. Herman Weiss                      • Chief Medical Officer at FibroControl, an Israeli medical device company focused on women's health.
Chairman, BoD                         • Practiced medicine in NY for 8 years, opening up a bladder health center and a female medical imaging center.
                                      • Board certified and a Diplomate of The American College of Obstetricians & Gynecologists.
                                      • MD, The Ohio State University College of Medicine; MBA from George Washington University
                                      • Over 25 years experience in management, marketing, sales and R&D
                                      • Seasoned executive at technology companies:
Rami Zigdon, MBA, EENG, BSc                • Country Manager, Hitachi Semiconductors, Renesas Technology, & Atmel
Co-Founder and CEO                         • Product Manager, Scitex (now HP)
                                           • CTO, NI Medical
                                      •   Over 10 years in biomedical engineering R&D
Dr. Udi Zelig                         •   Ben Gurion University and Medical School Instructor
Co-Founder and CTO                    •   Numerous medical and biophysics publications
                                      •   PhD, Biomedical Engineering: Ben Gurion University
                                      •   Over twenty years experience in healthcare and life sciences, include ten years total with Siemens Medical
Dr. Meir Silver                           Systems and Philips Medical Systems
VP Clinical Research and Regulatory   •   Extensive experience in oncology therapeutics, diagnostics and imaging.
                                      •   Over forty peer-reviewed publications and presentations.
Affairs                               •   Ph.D. in EECS from The Johns Hopkins University

Dr. Joseph Wee                        •   Over 45 years experience as a Productivity and Business Management Consultant to SMEs, MNCs, Government
                                          Linked Companies and Government Agencies
Managing Director                     •   Senior management and directorship positions in over 20 companies, including 3 listed companies
Todos Medical Singapore               •   Member of Advisory Committees appointed by a Singapore government agency

                                                                                                                                                       9
Q1/2018 Non Confidential Investor Presentation - Todos Medical
Global Cancer Diagnostics Market Overview

                           2015 Market Snapshot
                                     (USD Billions)                                                 •   The global cancer diagnostics market
                                                                                                        was valued at $114.5 billion USD in
                                                                                                        2015.

                                                                                                    •   By Screening Types:
                                                                                                        Imaging ($28.3B), Genetic Tests
                                                                                                    ($25.8B), and Laboratory Tests
                                                                                                    ($25.7B) each account for about a
                                                                                                    fourth of the market.

                                                                                                    •   By Application:
                                                                                                        Breast Cancer ($15.1B), Lung
                                                                                                    Cancer ($13.8B), Blood Cancer
                                                                                                    ($11.6B), and Colorectal Cancer
                                                                                                    ($11.3B) top the market.

Source: Cancer Diagnostics Market Analysis and Segment Forecast to 2025, Grand View Research 2016

                                                                                                                                           10
Rising Incidence
 Market Driver Analysis (1 of 4)                                                                                            of Cancer

 •     Cancer is a leading cause of death worldwide. According to the National Cancer Institute at the
       National Institutes of Health, around 8.2 million cancer deaths and 14 million new cases were
       registered in 2012.
 •     The following chart depicts estimated cases of most common cancer types in 2016:

                                  Cancer Cases by Type, 2016
                                                                                            ~250,000

                                                                                                       WHO claimed that cancer is the
                                                                                                       second most common cause of
                                                            ~150,000                                   death in the US, and accounts for
                                                                                                       nearly 1 of every 4 deaths in the
                                                                                                       region.

Source: Cancer Diagnostics Market Analysis and Segment Forecast to 2025, Grand View Research 2016

                                                                                                                                            11
Application Movement Analysis: Breast Cancer

•     Breast cancer has the largest prevalence rate. About 1 in 8 U.S. women develop invasive breast cancer as
      per the U.S. breast cancer statistics. It also reports that 246,660 new cases of invasive breast cancer are
      expected to occur in 2016.
•     Most of the times the symptoms of cancer are not identified in early stages and thus, screening tests are
      important for early diagnosis of the disease.
•     Imaging tests used for diagnosis of breast cancer are mammography, breast ultrasound, and magnetic
      resonance imaging (MRI). This imaging gives pictures of inside body structures, functions, as well as
      abnormalities that are caused due to presence of cancer.

                                                                  Breast Cancer Market
                                                                2014 – 2025 (USD Billion)

        The breast cancer
    segment of the market is
     expected to grow at the
      fastest CAGR of 8.8%
     over the forecast period
    and to reach $35.6 billion
             in 2025.

                                                                                                                    12
Application Movement Analysis: Colorectal Cancer

•   Colorectal cancer is a malignant type of cancer arising from the inner wall of large intestine.
•   According to National Cancer Institute, it is third most common type of cancer in men and women in the U.S.
•   Colorectal cancer can be hereditary in a family caused by colon polyps or by long standing ulcerative colitis. This
    cancer develops from colon polyps, thus, its removal can prevent cancer. However, colon polyps and early colon
    cancer show no symptoms, therefore regular screening is important.
•   Diagnosis and regular screening of cancer can be done using endoscopic methods such as colonoscopies and
    sigmoidoscopies. For further confirmation for presence of cancer, biopsy can be performed.
•   The treatment of colorectal cancer depends on its size, location, and extent of its spread. Thus, its early detection
    and regular screening is of high importance.

                                                                   Colorectal Cancer Market
                                                                   2014 – 2025 (USD Billion)

     The colorectal cancer
     segment of the market
    is expected to grow at a
      CAGR of 6% over the
     forecast period and to
      reach $20.7 billion in
             2025.

                                                                                                                            13
Large & Growing Addressable Market

 •        In women, breast cancer has the highest incidence rate
 •        In women and men, colorectal cancer has the 3rd highest incidence rate

                       Breast Cancer Screening                                                         Colorectal Cancer Screening
                           Eligible Candidates Market                                                        Eligible Candidates Market
                                                  In the EU,
              In the U.S.,                         64 M or                        In Asia, 50 M   In the U.S., 94 M    In the EU,     In Asia 64 M
            50 M or $1.0 B                          $1.2 B                          or $2.5 B         or $2.0 B         107M or         or $3.2 B
                                                                                                                         $2.3 B

                                               $4.7B TAM                                                              $7.5B TAM

Sources:
1)   American Cancer Society, 2009 Early Prevention & Early Detection Facts and Figures
2)   European Commission 2008 Report, Cancer Screening in the EU
3)   United Nations Department of Economic and Social Affairs
4)   IARC, 150 Cours Albert Thomas, 69372 Lyon CEDEX 08, France

                                                                                                                                                     14
Todos Medical Solution

•      No change to the standard practices for blood tests

•      Proprietary technology to analyze blood and detect the presence of various cancers

•      Todos Kit – specially prepared kit, including special glass slide and salt solution needed for the blood
       separation process, to ensure accurate and reliable TBIA

                                 Process in the Clinic or Lab
                                                                                                          Todos Cloud Server
                               Same process for all indications

      Standard Blood                        Mononuclear Cells &                     FTIR1 Analysis with   Results Reported to
    Draw with Todos Kit                      Plasma Separated                        Todos Algorithm            Doctor

1) Fourier Transform Infra-Red (FTIR) spectroscopic analysis of the immune system‘s response to cancer

                                                                                                                                15
Cloud Based Solution

                             Todos Medical
                            Data Warehouse

                             Todos Sell a Kit to
                              the lab or clinic

  Patient Data from lab +
                                                   Results
   FTIR Spectrum File

                            Hematologic Lab

                                                             16
Innovative Technology (Immune respond and FTIR)

•   Total Biochemical Infrared Analysis (TBIA) – FTIR spectroscopic analysis of cancers’ impact
    on the immune system
    – Most biomarkers’ assays depend upon a single or several markers which are directly related to
      the tumor
    – TBIA observes the biochemical composition of the plasma and peripheral blood mononuclear
      cells (PBMCs) and learns patterns in the biochemical snapshot which are characteristics of
      cancer patients
    – Multidimensional analysis characterizes each cancer and its stage according to different
      biochemical profiles, or “fingerprints”

                         Plasma & PBMC Analysis with FTIR:
              Simple, Automated, Cost Effective Early Cancer Detection
                                                                                                      17
The Technology
Combined FTIR Analysis of PBMC and Plasma

      Combined Plasma and PBMCs analysis results in high sensitivity & specificity test

                                                                                          18
Challenges With Current Detection Methods

Breast Cancer –
•   Mammography
                                                                            Low
    – Cost: approx. $200                                                 Sensitivity
    – Approx. 50% of women are poorly diagnosed                             and
    – Indeterminate mammograms require follow-up                         Specificity
      with MRI, 3D mammography and biopsies
    – High false positive cancer diagnosis rate
      (casing many un needed biopsies)                     Limited
    – Operator and equipment dependent
                                                          Availability
    – Limited access to current cancer screening
      methods in Eastern Europe, Asia and Africa due to
      the high cost of diagnostic imaging equipment
      outlays
                                                                           Costly
•   Genetic testing (BRACA I & II) requires follow-up
    with MRI, 3D mammography and biopsies
                                                                         Follow-up
    – Costly in time and money

                                                                                       19
Challenges with Detection Methods (Cont.)

Colorectal Cancer –
•   Colonoscopy
    – Cost: ~$1,000
    – Difficult preparation process; fasting and
      invasive procedure
    – Approx. 60% of patients refuse to undergo a
                                                         Poor Early
      colonoscopy; and about 80% adhere to blood         Detection
      test
    – Low patience compliance contributes to
      increased cancer incidence
                                                                         Low
• Stool Tests                                                         Compliance
    –   Cost: $5 to $500 (different performances)
    –   Poor clinical results for pre-malignant stages
    –   Requires submission of fecal “stool” samples
    –   Low patient compliance
                                                             Painful &
                                                             Invasive

                                                                                   20
The Solution Trifecta

•   Todos’ solution is a triple win appealing to all three participants

                                       Patient
                                - Simple blood test
                                - Early cancer detection

                       Payer                               Physician
            - Low cost test
                                                      - Patient compliance
            - Saving on expensive treatment
                                                      - Fast detection for
                                                        early stages

                                                                                                               21
                                                                        1)   Based on latest clinical trials
Comparable Companies

                    Todos Medical        Exact Science         Volition RX   Epigenomics     Provista
                       TOMDF                EXAS                 VNRX          EPGNF       Diagnostics
                    IVD / CRC+ Breast        Stool / CRC           IVD CRC     IVD CRC       IVD Breast

Early Stage
Detection
                       PPP                     P                 PP              P              NA

Sensitivity &
Specificity in         PPP                  PPP                  PP             PP          PPP
advanced cancer
Target Population      PPP                     P                     NA
                                                                                 P              NA

Cost
                       PPP                     P                 PP             PP              NA

Scalable platform
                       PPP                     P                 PP              P           PP
Maturity
                         PP                 PPP                  PP            PPP           PP
Market cap *                                    $6B                 $80M        $120M
~ USD

                                Note: Q1/2018; According to Todos Medical
A Superior Solution

                                                              Competing Tests

•   Immune system indication
     –   The only test that looks at the immune system to
         identify the presence of cancer
•   Results
     –   Early stage cancer detection
     –   Sensitivity and specificity in advanced cancer
     –   Increased compliance and prevention
•   Simple Process
     –   Simple blood test with fast indication for high or
         or low risk
•   Low Cost / Cost-effective Method
     –   Centralized evaluation
     –   Same process used for many tests

                                                                                23
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

                                                                                                                      24
Intellectual Property (IP) Portfolio

•       TODOS Medical has the exclusive worldwide rights to use the IP for commercial and R&D
        purposes. Three patents are currently granted:

               Patent Number                                                Description                                       Issue Date   Exp. Date

    Category I: These applications relate to analysis of an IR spectrum of a PBMC sample. Claims are generally directed to
    indicating the presence of a solid tumor based on analysis of an IR spectrum of a PBMC sample.
    US Patent 9,606,057                     Method. Presence of a solid tumor in breast tissue based on analysis of an        28-Mar-17     1-Jun-31
                                            IR spectrum of a PBMC sample.
    Continuation of U.S. Patent 9,606,057   Presence of a solid tumor in tissue of a gastrointestinal tract based on                        1-Jun-31
                                            analysis of an IR spectrum of a PBMC sample.

    Category II: These applications relate to analysis of an IR spectrum of a blood plasma sample. Claims are generally directed
    to indicating the presence of a solid tumor based on analysis of an IR spectrum of a blood plasma sample.
    US Patent 9,719,937                      Method (process), a system, and for a computer program product. The               1-Aug-17    10-May-32
                                            claims in this application are generally directed to indicating the presence of
                                            a solid tumor in a gastrointestinal tract based on analysis of an IR spectrum
                                            of a blood plasma sample.

    Continuation of US Patent 9,719,937.    This has claims for a method (process), a system, and for a computer                           10-May-32
                                            program product.

    Category III: Application relates to analysis of an IR spectrum of a blood plasma sample and PBMC samples.
    US Patent 9,804,145                     The claims in this application are generally directed to (i) analysis of an        31-Oct-17   14-Nov-33
                                            infrared (“IR”) spectrum of a peripheral blood mononuclear cells (“PBMC”)
                                            to indicate the presence of a benign tumor in breast tissue and in the
                                            gastrointestinal tract, and (ii) analysis of an infrared (“IR”) spectrum of a
                                            blood plasma sample to indicate the presence of a benign tumor.

                                                                                                                                                       25
Thank You!

For Additional Information:

                                Rami Zigdon
                                        CEO

              Telephone: +972-54-638-0666 | Main Office: +972-8-633-3964
                               rami@todosmedical.com
You can also read
Next slide ... Cancel