Immune-based blood diagnostics for cancer and neurologic disease - Corporate Presentation June 2019 OTC TOMDF - Investor Relations | Todos Medical
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
Immune-based blood diagnostics for cancer and
neurologic disease
Corporate Presentation
June 2019
OTC TOMDF
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. More detailed information about the risks and uncertainties affecting the
company is contained in Todos Medical Ltd.’s Annual Report on Form 20-F for the fiscal year
ended December 31, 2018 filed in March 29, 2019 with the U.S. Securities and Exchange
Commission (“SEC”) and available on the SEC's website, www.sec.gov. and in the Company’s
periodic reports filed with the SEC.
2
Todos Medical - Overview
• A clinical-stage diagnostics company and leader in Immuno-Diagnostic
space focused on the development of blood-based tests for the early
detection of cancers and neurodegenerative (ND) diseases
• Portfolio
− The TBIA Platform –for the diagnostic Todos Breast Screens (TM-B1,
TM-B2) and Todos Colon Screen (TM-C1)
o “Total Biochemical Infrared Analysis” (TBIA) method, a
proprietary method for screening of solid tumors using peripheral
blood spectroscopy analysis
− LymPro Test® for Alzheimer’s disease (possibly additional ND diseases)
o “Lymphocyte Proliferation test” (LymPro Test) measures immune
markers that are directly linked to well established cell
proliferation processes
3
Investment Thesis
Todos is positioned to become a leader in the Immuno-Diagnostic space
• Strong IP portfolio relating to harnessing the immune system to diagnose
disease
Focusing on high unmet medical need in early diagnosis of cancers
• Aiding in the screening of patients with dense breast tissue
• Colon cancer screening with simple blood test
• First blood-based screening test for lung cancer
Positive data supporting Todos’ blood test to diagnose early stage
Neurodegenerative disease – first of its kind in:
• Alzheimer’s Disease
• Chronic Traumatic Encephalopathy (CTE)
4
Current Pipeline
Marker RUO IUO CE Mark CLIA US FDA
TM-B1: Breast Cancer CE mark received
TM-B2: Breast Cancer
TM-C1: Colorectal Cancer
LymPro Test®: Alzheimer’s disease
TM-B1 TM-B2 TM-C1 LymPro
Breast Cancer Breast Cancer Colorectal Cancer Alzheimer’s Disease
• TM-B1 is a test designed • TM-B2 designed for early • TM-C1 designed for • The LymPro test is a
specifically for breast detection of breast early detection of validated blood-based
cancer screening. cancer. colorectal cancer. It is lymphocyte assay that
• It is indicated for indicated for men and can assist research
• It is indicated for women
women 25 years and women, aged 50 years professionals in
25 years and older
older without a and older, without a differentiating between
without a diagnosis of
diagnosis of diagnosis of non-AD subjects and
inflammatory or
inflammatory or autoimmune disease and inflammatory or those with prodromal
autoimmune disease. who were diagnosed as autoimmune disease. AD, mild cognitive
presenting with BI-RADS impairment (MCI) due to
• TM-B1 is to be used as a AD or dementia due to
score of 3 or 4 (or
screening method to AD.
equivalent). TM-B2 is to
indicate whether a be used to further assess
malignancy is present. if a malignancy is
present.
Todos Cancer Screens - The Biological Rational
• Different cancers influence the immune system differently
• Same TBIA method with varying algorithms can detect different
cancers
Breast cancer Colon cancer
Ladoire et al. Cancer Immunology, Immunotherapy 60.7 (2011): 909-918.
6
Todos Cancer Screens - The Unmet Need
• Cancer screening tests, Breast cancer
especially those for Mammography has significant limits with average
breast and colorectal sensitivity of just 70% and even lower among
have well known women with dense breast tissue, which is present
limitations and in a majority of women under the age of 50.
compliance shortcomings Mammography is operator dependent and an
due to their invasiveness uncomfortable procedure for many women.
and significant expense. Outside of the US and EU, mammograms are not as
• Many of the effective readily available.
screening methods
remain too expensive for Colorectal Cancer
adoption as screening Colonoscopy is the current standard in CRC
tests for all those at risk screening. While accurate, the procedure is
and are often used too invasive, operator dependent and expensive,
rarely and too late. contributing to low compliance among patients.
• Early cancer diagnosis Cologuard, a recently approved fecal-based test
saves 50% in costs -
by Exact Sciences, is a major advance in CRC
Cancer costs expected to
screening. However, the expensive test is unable
reach over $150B in
to detect precancerous polyps and has only 50%
2020.
patient compliance.
7
Todos Cancer Screens - Workflow
Standard Mononuclear FTIR
Blood Draw Cells & Analysis Results
with Todos Plasma with Todos Reported to
Kit Separated Algorithm Doctor
15 min 2 hr 30min/ 1min
patient
6 hr Can be 1min
kept
frozen up
to
3 weeks
8
Todos Breast Cancer Screens - Latest Clinical Trial Results
Date of Published Results
March 22, 2018
About the TM-B1 Assay
The TM-B1 assay is indicated for women aged 25 years and older without a
diagnosis of inflammatory disease. The assay is intended to be used as a
diagnostic method to indicate whether a breast malignancy is present or not. The
trial was prospective, two arms, unblinded and consisted of 220 female subjects
Results of Trial
• Sensitivity of 86% & Specificity 98% for breast cancer detection
• Positive Predictive Value (PPV) was 95.1% & Negative Predictive Data was 93.5%
• Dense breast tissue (BIRADS categories 3&4) were present in 55% of subjects
• For dense breast patients, specificity was 99% and sensitivity was 83%
• No Major differences in accuracy based on patients age
• Abstract presented at SABCS 2018
9
Todos Breast Cancer Screen Go To Market Strategy
Received approval from the Israeli Ministry of Health (AMAR) to market
and sell its breast cancer tests TM-B1 and TM-B2.
• Signed an exclusive distribution rights and sales agreement of TM-B2
blood tests for breast cancer screening within the State of Israel
Initial sales efforts to focus on the European Union as CE mark has been
granted
• Initial pilot studies are expected to begin in Q3 2019 in Europe
Entering the U.S. market
• FDA will accept European scientific data for portion of the data package
• Evaluating CLIA pathway in parallel with FDA process
10Todos Medical
LymPro ® Alzheimer’s
Assay
11Alzheimer's: $250B Market Growing to $1.2T by 2050
✓ 1 in 9 Americans over 65 has AD
Healthcare Spend on
Alzheimer’s ✓ 5.2 million Americans have AD
$ Billions ✓ 500,000 new diagnoses per year
✓ $250B market in the US
1200 ✓ 10% of healthcare spending
✓ Projected $1.2T market in US by 2050
✓ Key unmet need: accurate early diagnostic
• Pre-screening of patients to reduce pharma
patient acquisition cost 50%+
• Data generated will add validity to test while
203 building commercial story
• Mechanisms of fundamental disease biology:
Emerging Therapeutic Targets
2013 2050
• $1B IUO market opportunity dominated by PET
imaging
12Cell Cycle Dysregulation & Alzheimer’s
• Adult Neurons are terminally
differentiated but in AD, neurons
quiescent inappropriately re-enter cell cycle (cell
G0 division process)
• Cell cycle dysregulation (CCD) linked to
expression of toxic misfolded proteins
amyloid and tau in the brain
Gap-1
Mitosis • Occurs early in disease (MCI or earlier)
Gap-2
Synthesis
MGS1
G • Leads to early neuron death
2
• Dysregulation seen in peripheral tissues
including lymphocytes, fibroblasts
• CCD in lymphocytes is measured via
flow cytometer
Stieler, J., Lederer, C., BruÈckner, M., Wolf, H., Holzer, M., Gertzand, H., Arendt, T., 21 December 2001, Impairment of mitogenic activation of
peripheral blood lymphocytes in Alzheimer's disease. Neuroreport, 12 :18; 3969-3972
Peipei Li, Lee Marshall, Gabriel Oh, Jennifer L. Jakubowski, Daniel Groot, Yu He, Ting Wang, Arturas Petronis, & Viviane Labrie Epigenetic
dysregulation of enhancers in neurons is associated with Alzheimer’s disease pathology and cognitive symptoms NATURE COMMUNICATIONS |
(2019)10:2246 | https://doi.org/10.1038/s41467-019-10101-7
13Immediate Use Cases Prior to AD Drug on Market
Pre-Screen for enrollment in Alzheimer’s clinical trials
• Use LymPro to stratify population at lower cost prior to advancing to PET
imaging or CSF amyloid/tau biomarker evaluation
Companion Diagnostic
• Potential for development as a companion diagnostic for monitoring
efficacy of drugs with certain CCD related mechanisms of action
• Ultimately needed to identify AD for payors to justify drug therapy cost
Diagnostic
• Assist physicians in diagnosing AD patients from those with other
dementing conditions
14LymPro Test - Go To Market Strategy
• File new IP based on data from ongoing trials at University of
Leipzig in Germany
• Initial sales efforts Pharmaceutical clinical trials
• Pilot studies are expected to begin in 2020
• Ex-US strategy to be implemented, CE mark, etc.
15Todos Medical – Upcoming Catalysts
TM-B1 and TM-B2
• Ex-US commercial partnership
• Publish clinical utility data
• Commercial launch in Europe & evaluate US CLIA pathway
LymPro Test®
• File IP based on new Data from Leipzig University
• Leipzig Data publication
• CLIA Pathway & evaluate European 510(k)
16Management Team
Dr. Herman Weiss, MD, MBA, FACOG – President & CEO
Former VP, Medical Affairs and Clinical Development of Juniper Pharmaceuticals Inc.
Former Global Medical Director of Women’s Health and Bone Health at Teva Pharmaceutical Industries.
Dr. Udi Zelig, PhD – CTO
Scientific founder of Todos Medical & Senior at Ben Gurion University
Former Chief Technology Officer at Crow Technologies
Michael T. Ropacki, PHD - Chief Medical Advisor, LymPro for Alzheimer’s
SVP Clinical Development at MedAvante-ProPhase
Former Global Medical Affairs Leader, Head of Late-Stage Development at Janssen Alzheimer's
Immunotherapy
Brian E. Harvey, MD, PHD - Chief Regulatory Advisor
Former Vice President of U.S Regulatory Strategy at Pfizer
Former Vice President of Regulatory Policy at Sanofi
Mr. David Ben Naim, MBA, CPA - CFO
Former CFO at Insuline Medical Inc (TASE – INSL), Crow Technologies (OTCQB – CRWTF), Ilex Medical
Limited (TASE), Microbot Medical (NASDAQ – MBOT) and Vonetize PLC (TASE – VNTZ).
Advisors:
Gerald Commissiong: President & CEO of Amarantus Bioscience Holdings, In
17Capital Structure Snapshot May 2019
• Market Cap of 19M
• $4.4M raised to date
− $2.8M common Equity
− $1.6M in debt raised in February 2019
• 93.5 Million shares outstanding (founders, early investors and JV)
• 158 Million fully diluted shares after pending acquisition with Market Cap
of 30M
• Outstanding warrants
− 6.7 Million warrants outstanding at $.50
− 4 Million bridge financing warrants
• Quoted on the OTC April 2017
• Float of approximately 45 Million shares
• Nasdaq listing targeted for Q3/19
18Todos Medical
Appendix
19Clinical Validation in Breast & Colorectal Cancer Screening
Four Peer Reviewed Publications
• Barlev, E., Zelig, U., Bar, O., Segev, C., Mordechai, S., Kapelushnik, J., ... & Madhala-
Givon, O. (2016). A novel method for screening colorectal cancer by infrared
spectroscopy of peripheral blood mononuclear cells and plasma. Journal of
gastroenterology, 51(3), 214-221.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
20Early cancer diagnosis saves 50% in Costs
7. Conclusions
The above rough estimate for cost-savings from early cancer diagnosis, $26B, is only about 17% of
the total estimated expenditures (see Table 11) and appears to be reasonable despite various built-
in (conservative) extrapolations. If we take breast, lung, prostate and colorectal cancers and
melanoma, which are top five cancers by incidence with the total 859,110 estimated new cases in
2017, which amounts to 50.87% of all 1,688,780 estimated new cases across all cancer sites, 19 the
estimated costs add up to over $67B (or about 43.87% of costs for all sites), ad the corresponding
estimated cost-savings from early diagnosis add up to over $10.7B (or about 41.49% of cost-savings
for all sites). Again, these figures should be considered keeping in mind the caveats we discuss
above. Even assuming only 50%, the cost savings are staggering.20
21Thank You!
For Additional Information:
Herman Weiss, MD MBA
CEO Chairman
Telephone: +972-58-444-7873, +1-617-483-5956| Main Office: +972-8-633-3964
herman.w@todosmedical.comYou can also read
