Q1/2018 Non Confidential Investor Presentation - Todos Medical
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Non Confidential Investor Presentation
Q1/2018
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)
TODOS Medical Company Vision
Creating a better and more affordable way of cancer
screening to improve treatment and reduce mortality.
3
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
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
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
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
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
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
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
10Rising 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
11Application 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.
12Application 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.
13Large & 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
14Todos 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
15Cloud 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
16Innovative 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
17The Technology
Combined FTIR Analysis of PBMC and Plasma
Combined Plasma and PBMCs analysis results in high sensitivity & specificity test
18Challenges 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
19Challenges 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
20The 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 trialsComparable 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 MedicalA 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
23Publications 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
24Intellectual 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.
25Thank You!
For Additional Information:
Rami Zigdon
CEO
Telephone: +972-54-638-0666 | Main Office: +972-8-633-3964
rami@todosmedical.comYou can also read
