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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
June 2016
OTC: BMKDF
CSE: BUX
www.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 Overview
Why We Are
•To provide universal access to 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 exclusively licensed from the University of Manitoba in Canada. FTO status ;
-Collaborated with Dr. David Wishart at TMIC University of Alberta
TMIC : The Metabolomics Innovation Centre
-Multiple IPs generated in detection and quantitation of metabolites
-Hand-picked, proven, global enterprise team of scientists, engineers and medical
professionals
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 4
Executive Team
Rashid Ahmed – Founder, Chief Executive Officer
Dr. Thomas Malcolm – President & Chief Scientific Officer USA
Dr. Bram Ramjiawan – Clinical Trial and Regulatory Expertise
Brian Cheng – Chief Technical Officer
Abbey Abdiye – Chief Financial Officer
Dr. Kenneth Kohn – Patent Attorney USA
Gina Huang – Project Director
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 5
Scientific and Supporting Board
Research / Scientific / Clinical
Dr. 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 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 / USA
Dr. Debra Hoffman – Lung Oncology Surgeon / USA
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 6
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
• Rapid growth in retail health spurring need for better
diagnostics
• Launching new paradigm for early cancer detection based on
metabolites with potential to become new standard of care
- Levels of detection magnified compared with traditional biomarkers
- High percentage of cancers are curable when caught at very early
stage* • * WHO “Cancer” Feb. 2014
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 7
Investment Highlights
• Lead technology features non-invasive approach with high
specificity and sensitivity
• Planned submission for Health Canada in 2Q/Q3 2016 –
approval expected in 6-9 months pending results; FDA
submission to follow
• 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 8
Global Cancer Diagnostics Market
Size of Next-Generation* Cancer Diagnostic
to Total Diagnostic Market, 2014 - 2019
$117.6
Billion
$1.8 B
2014
$157.5
Billion
$10 B
2019
0
2
4
6
8
10
12
2014 2019
U.S
. D
olla
rs in
Bill
ion
s
Year
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 9
Current Cancer Detection Methods • Imaging
• CT ( Computed Tomography)
• Mammograms
• MRI
• Fluorescent
Challenge: There is limit to its sensitivity, as tumors that are less than 1 cm can be detected
only on rare occasions
• Endoscopy – Typically detected late
• Cell Morphology – biopsy or cytology – Gold standard
Challenge: Very subjective
• Cancer Biomarkers (DNA; mRNA; Protein and Metabolites)
Challenge: Insensitive and non specific (e.g. PSA)
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 10
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
*Spermidine/Spermine Acetyltransferase
Allows physicians to detect carcinomas before they are symptomatic and visible
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 11
BioMark Advantage – early and better detection
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 12
Methods of Amantadine Detection – Developed and owned by BioMark
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 6-9
months post trial results
•Accurate detection from urine
•In vitro point-of-care testing
•Completed validation of highly specific monoclonal antibodies
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 13
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 using new imprinted
polymers (current development)
• Enhancing signal on the substrate for actual urine samples
Methods of Amantadine Detection – Developed and owned by BioMark
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 14
Metabolite Fingerprint Diagnostic Assays - In Development and Revalidation Stage
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 potential 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 15
BioMark’s Clinical Utility
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 16
Target Market Focus
Market Focus
Lung Cancer: Response to
Treatment – Surgical and
Chemo
Red alert monitoring for
cancer recurrence
Low cost screening tool for
high risk lung cancer – ex
smokers
Surrogate biomarker
(CDx )for Phase 1 drug trial
Completed Phase 3 clinical
trials in Canada and
Bangladesh.
Conduct possible trials in
U.S. and India in late 2016
Market Potential
Lung Cancer Diagnostic Global -
$1.2 Billion
15 million cancer survivors in
North America
> 2 billion patients globally
Source: Global Data MediPoint May 2014
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 17
Product Development Pipeline
SSAT-Amantadine Assay using LC/MS
SSAT-Amantadine Assay using
Raman
Lung Cancer Metabolic Fingerprints
Other Cancer
Fingerprints
SSAT-Amantadine Assay using ELISA Kit
Development Validation U.S.
Approval Market Planning
Internal standards developed and data
points collected and to be validated.
Transferable to FDA
In collaboration with Kestrel Sciences
to begin validation post trial results
Developing N-acetylamantadine
separation chemistry
Data collection - revalidation and assay
optimization lung cancer
Prostate, Breast, Cervical,
Ovarian, CRC, GI in architecture
Polyamine
and other
Pathways
Up to 6 months
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 18
Regulatory Trials Planned Timelines – Health Canada and FDA
Trials Expected Timing
220 Patient Trial
Internal Standards developed Data Readout and Analysis Completed
Health Canada Submission 3Q16
Health Canada Approval Decision 2016/17
FDA Submission/Approval 2H17
Response to Treatment - Chemotherapeutic and Surgical Intervention
Trial approvals and initiate enrollment 2Q16
Data Readout 4Q16
Health Canada and FDA approval for study expansion 1Q17
Lung Fingerprint; Breast and other Fingerprints
Expand sample size and analyze data for staging 2Q16
Optimize assay for revalidation at TMIC and
Present data to Health Canada and FDA 2H16
Complete pilot study and expand sample size 2H16
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 19
Competitive Landscape
Company Biomarker Cancer Diagnostic Pre-Visible
Tumor
Detection
Pre-
Symptomatic
Tumors
Development
Stage
BioMark
Diagnostics N-acetylamantadine
Broad coverage
Lung, breast, prostate
YES YES Lung Cancer
Near to Market
Cellmid Ltd. Midkine
Broad coverage
Prostate, GI, stromal,
bladder, colorectal,
esophageal, thyroid,
pancreatic, bile duct
NA YES Preclinical
Matrix-Bio VermarkerTM Liver
VeraMarkerTM Colon
Broad coverage
Liver and Colon YES YES
Liver
Near to Market
Panacea YES NO Preclinical
Nuvera
(CRO)
BioInformatics/
Analytical Approach –
Genetic, protein and
metabolites
expression profiles
Broad coverage NA NA Preclinical
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 20
Potential Revenue Streams
Sales of products / supplies (kits and internal standards)
Royalty on lab analysis (per test)
Licensing – Territorial and distribution licensing
Services
• Monitoring
• CDx for drug companies (Surrogate Biomarker)
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 21
Share Structure
• Share Summary
- Shares: 53,345,776 / Tradable Share: 23,345,776
- Warrants: 1,363,181
• Private Placement
• November 2014: at 25 cents, raised $ 530,000, no warrants.
• February 2015: at 50 cents, raised $ 750,000, warrants expired.
• March 2016: at 15 cents, raised $ 408,954, with half warrants at 30 cents
planned to raise a total of $ 950,000 by August 2016
• Financial
• Year-End: March 31, 2015
• Quarter-End: December 31, 2015 (the latest reports)
* Reported under IFRS international reporting standard
• Counsel: Bacchus Law Group
• Auditors: Manning Elliott LLP
• Information Sources: sedar. com & thecse.ca
LISTING:
- CSE: BUX CANADA - OTCQB: BMKDF U.S.A
- FSE: 20B GERMANY
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 22
Proposed Use of Proceeds
‣ Complete protocol development, submissions to Health Canada and
commence studies for to lung cancer chemo and resection studies
‣ Assay optimization and re-validation and Kit development for lung cancer
fingerprints (TMIC)
‣ Patent fillings and support
‣ Data Compilation and Follow up trials
‣ Investor relation and market support
‣ Market and promotion support
‣ Health Canada Application and Filing fees
‣ Working Capital and business development
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics 23
Investment Highlights
• Addressing global next-generation cancer diagnostics market expected to
reach $10 billion by 2019
• Launching new paradigm for early cancer detection based on metabolites
with potential to become new standard of care
• Cost reduction in medical care or improved productivity
• New consumer health propelling disruption in existing model
• 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