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BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 1
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics
Rodman & Renshaw Global Investment Conference
September 9, 2015
OTC: BMKDFwww.biomarkdiagnostics.com
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 2
Forward-Looking Statements
Certain statements or projections contained in this presentation are forward-
looking statements, including those that discuss strategies, goals, outlook or
other non-historical matters; or project revenues, income, product
development, regulatory approval, returns or other financial measures.
These forward-looking statements speak only as of the date on which they are
made, and BioMark Diagnostics Inc. or any of its subsidiaries undertakes no
obligation to update or revise any forward-looking statements. These forward-
looking statements are subject to risks and uncertainties that may cause
actual results to differ materially from those contained in the statements.
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 3
Company OverviewWhy We Are
• To provide universal access to ultra-early cancer detection through a new paradigm in cancer diagnostics using metabolomics
Who We Are
• Oncology-focused company with advanced near-to-market diagnostic technologies
• Core IP licensed from the University of Manitoba in Canada
• Hand-picked, proven, global enterprise team of scientists, engineers and medical professionals
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 4
Investment Highlights• Addressing global next-generation cancer diagnostics market expected
to reach $10 billion by 2019
• Growth fueled by new cancer therapeutics, monitoring and companion diagnostics – era of personalized medicine
• Launching new paradigm for ultra-early cancer detection based on metabolites with potential to become new standard of care
• Levels of detection magnified compared with traditional biomarkers
• 90% of cancers are curable when caught at very early stage*
• Lead technology features non-invasive approach with high specificity and sensitivity
• Planned submission for Health Canada in 1Q 2016 – approval expected in 6-9 months; FDA approval within 1 year following Health Canada
• Potential to generate multiple revenue streams from product supply, royalties, licensing and services
• World-class team and capital-efficient business model * WHO “Cancer” Feb. 2014
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 5
Global Cancer Diagnostics Market
Size of Next-Generation* Cancer Diagnostic to Total Diagnostic Market, 2014 - 2019
$117.6Billion
$1.8 B
2014
$157.5Billion
$10 B
2019
0
2
4
6
8
10
12
2014 2019
U.S
. D
ollars
in
Billion
sYear
40% CAGR
Next-Generation Cancer Diagnostic Market Growth Projections
10 B
1.8 B
*Genetic screening; protein biomarkers; molecular biology; bioinformatics and metabolomics
Source: Criterion Bioscience Report 2015
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 6
BioMark - New Paradigm in Cancer Diagnostics • Portfolio of cancer diagnostic technologies based on metabolites
• Detection of over-expression of an enzyme SSAT1*
• Subject ingests FDA-approved drug amantadine which is converted into acetylated form
• Detecting by-product of SSAT1 reaction - safe, stable indicator healthy vs. cancerous cells making for an ideal biomarker
• SSAT1 highly expressed in breast, lung, melanoma, GI and prostate cancers
• First diagnostic tests using urine with detection through liquid chromatography-mass spectrometry (LC/MS) and ELISA kits
• Developing additional cancer detection methods specific to cancer types
• SSAT1 signature expression diagnostic assays for lung, breast and other types of cancers
• Metabolite fingerprint diagnostic assays for lung, breast and other types of cancers
*Spermidine/Spermine Acetyltransferase
Allows physicians to detect carcinomas before they are symptomatic and visible
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 7
BioMark Advantage
BioMark Metabolite Approach
Traditional Biomarkers
Detection through accumulated by-product
of enzyme reaction
Limited levels of biomarkers create
detection challenges
Levels of detection many times better than traditional biomarkers
Typically limited to detection at post-
symptomatic stages
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 8
Methods of Amantadine Detection
Amantadine is the preferred substrate for SSAT(activity of SSAT to substrate)
NormalPancreatic Cells
Pancreatic Cancer Cells
LC/MS –Gold Standard• Highly sensitive detection from urine • Secured Investigational and Testing Authorization
from Health Canada 2014
ELISA Kit – project started with Kestrel; prototype expected in 6 months
• Accurate detection from urine• In vitro point-of-care testing• Completed validation of highly specific monoclonal
antibodies
IVD Kit• Home antibody test for detection in urine • Use by cancer survivors for monitoring or cancer-free
progression status
Surface-enhanced Raman Spectroscopy (SERS)• Highly accurate photonic approach using urine • Compact, simple to use, inexpensive, potential for
significant market penetration• Not as sensitive as LC/MS but can be improved• Enhancing signal on the substrate for actual urine
samples
Source: Dr. Horacio, UBC Proteomic Centre 2015
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 9
Signatures Diagnostic Assay
Resolving unique SSAT1 expression signatures for breast, lung, colorectal, glioblastoma, prostate and ovarian cancers
• Measure SSAT1 levels in cancer vs. healthy cells
• SSAT1 levels vary in different cancer types/stages
• Slightly more invasive and requires collection of blood or tissues
• As more data is collected, the mean level of SSAT1 in each cancer will be accurately defined
Signatures used for secondary follow-up assays to original SSAT1-Amantadine assay
SSAT1 Breast Cancer – Various Grades and Stages
SSAT1 Glioblastoma – Various Grades and Stages
Source: BioMark Diagnostics Inc.
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 10
Metabolite Fingerprint Diagnostic Assays
Resolving metabolite fingerprints for lung cancer in various stages • Measure levels of various empirically chosen
metabolites in urine associated with lung cancer
• Non-invasive
• Metabolites measured using LC/MS and DI-MS (Direct flow Injection) with high reproducibility
• As more data is collected, the mean level of metabolites per stage will be accurately defined
Use in secondary follow-up assays to SSAT1-Amantadine assay
Future detection of various stages of breast, prostate, colorectal, glioblastoma, and ovarian cancers
Source: BioMark results conducted at BRI Canada
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 11
Target Market Focus
Market Focus
Lung Cancer: response to treatment
Red alert for cancer recurrence
General cancer screening
Plan to conduct Phase 3 clinical trials in Canada and Bangladesh, possibly in U.S. in late 2016
Market Potential
Lung Cancer Diagnostic Global - $1.2 Billion
15 million cancer survivors in North America
>4 billion patients globally
Source: Global Data MediPoint May 2014
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 12
Product Development Pipeline
SSAT-Amantadine Assay using LC/MS
SSAT-Amantadine Assay using Raman
Lung Cancer Metabolic Fingerprint
Other Cancer Fingerprints
SSAT-Amantadine Assay using ELISA Kit
Development ValidationU.S.
ApprovalMarketPlanning
Data points collected and validatedTransferable to FDA
In collaboration withKestrel Sciences to begin validation
Developing N-acetylamantadineseparation chemistry
Data collection - all lung cancer stages
Prostate, Breast, Cervical, Ovarian, CRC, GI in architecture
PolyaminePathway
Up to 6 months
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 13
Transferable Clinical Trials Data
• Trials registered at www.clinicaltrials.gov
• Protocols developed under Health Canada guidelines and approved by Canadian and Bangladesh ethics boards
• Completed >200 patient screening trial - lung, breast and GI cancer
• Obtained extension of study from Health Canada for additional 300 patients – for lung, breast and GI cancers
• Data can be used for submission to Health Canada and FDA
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 14
Clinical Trials • 220 patients in Canada and Bangladesh
• Lung, breast, GI cancers against healthy control using LC/MS
• Samples are collected and sent to labs for validation
• 4Q15 - Data analysis and readout
• 1Q16 - Submission to Health Canada
• 300 patient extension from Health Canada• Allows for more quantification
• Could speed up approval process
• 40 patient study assessing surgical intervention in lung cancer• Conducted by Dr. James Bond, Chief of Surrey Memorial Hospital Thoracic Surgery Team
• Protocols established; waiting for final approval
• 1Q16 – Data readout and analysis
• 20 patient response to chemotherapeutic treatment study• Conducted at CancerCare Manitoba
• 1Q16 – data readout and analysis
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 15
Regulatory Timelines – Health Canada and FDA
Trials Expected Timing220 Patient Trial Data Readout and Analysis
4Q15
Health Canada Submission 1Q16
Health Canada Approval Decision 3Q16
FDA Submission/Approval 2H17
Response to Treatment - Chemotherapeutic and Surgical Intervention
Trial approvals and initiate enrollment 4Q15
Data Readout 1Q16
Health Canada and FDA approval for study expansion 3Q16
Lung Fingerprint; Breast and other Fingerprints
Expand sample size and analyze data for staging 4Q15
Present data to Health Canada and FDA 1H16
Complete pilot study and expand sample size 1H16
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 16
Competitive Landscape – Ultra-Early Detection
Company
Biomarker Cancer Diagnostic Pre-Visible Tumor Detection
Pre-Symptomatic Tumors
Development Stage
BioMark Diagnostics
N-acetylamantadine
Broad coverage
Lung, breast, melanoma, GI, prostate
YES YES Market
Cellmid Ltd.
Midkine
Broad coverage
Prostate, GI, stromal, bladder, colorectal, esophageal, thyroid, pancreatic, bile duct
NA YES Preclinical
Matrix-BioVermarkerTM LiverVeraMarkerTM
Colon
Broad coverageLiver and Colon
YES YESLiver: Market in 2016
Panacea YES NO Preclinical
Nuvera (CRO)
BioInformatics/Analytical Approach – Genetic, protein and metabolites expression profiles
Broad coverage NA NA U.S. Market
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 17
Potential Revenue Streams
Sales of products / supplies
Royalty on lab analysis (per test)
Licensing – Territorial and distribution licensing
Services• CDx for drug companies
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 18
• Establishing U.S. headquarters in the Maryland biotechnology center
• Appointed Dr. Thomas Malcolm as Chief Scientific Officer and Head of U.S. Operations
• Plan to submit SSAT-1 Acetyl Amantadine assay for regulatory approval to FDA
Strategy to Build U.S. Presence
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 19
Executive Team
Rashid Ahmed Founder, Chief Executive Officer
Dr. Thomas Malcolm President & Chief Scientific Officer
Brian Cheng Chief Technical Officer
Abbey Abdiye Chief Financial Officer (Canada)
Neal Kaplan Chief Financial Officer (U.S.)
Jim Elliott Downstream Technology Advisor and QMS Support North American Management
Dr. Kenneth Kohn Patent Attorney
Gina Huang Project Director
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 20
Scientific and Supporting BoardDr. Daniel S. Sitar Principal Scientific Advisor/Consultant
Dr. John Yoo Clinical Oncologist - Co-Chair CancerCare Ontario Head and Neck; Professor, Dept. of Oncology, Schulich School of Medicine & Dentistry, Western Ontario
Dr. John Schrader Antibody Development - Chair of Biomedical, Research Centre, University of British Columbia
Dr. Horacio Bach Faculty Manager of Immunity and Infection Research Centre Antibody Engineering and Proteomics Facility Department of Medicine, Division of Infectious Diseases University of British Columbia, Jack Bell Research Centre
Dr. Safieddin Safavi-Naeini
NSERC/BlackBerry Industrial Research Chair, University of Waterloo
Supporting
Dr. Reuven Gordon and Dr. Fraser Hof – Canadian Research Chairs, University of Victoria
Dr. Andrew Maksymiuk – University of Manitoba and Manitoba Cancer Care
Dr. James Bond – Chief of Surrey Hospital Thoracic Surgery Team
Dr. Dwight De Risi – Breast Oncology Surgeon
Dr. Debra Hoffman – Lung Oncology Surgeon
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 21
Investment Highlights
• Addressing global next-generation cancer diagnostics market expected to reach $10 billion by 2019
• Launching new paradigm for ultra-early cancer detection based on metabolites with potential to become new standard of care
• Lead technology features non-invasive approach with high specificity and sensitivity
• Planned submissions for Health Canada and FDA approvals
• Generating current revenue from product supply with multiple future revenue streams from royalties, licensing and services
• World-class team and capital-efficient business model