Transcript diagnostics inc - Biomark Diagnostics

BioMark DIAGNOSTICS
INC
A Next Generation Company Powered by Metabolomics
Rodman & Renshaw Global Investment Conference
September 9, 2015
OTC: BMKDF
www.biomarkdiagnostics.com
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics
1
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
2
Company Overview
Why 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
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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
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Global Cancer Diagnostics Market
Size of Next-Generation* Cancer Diagnostic
to Total Diagnostic Market, 2014 - 2019
Next-Generation Cancer Diagnostic
Market Growth Projections
$157.5
Billion
$117.6
Billion
$10 B
$1.8 B
2014
2019
*Genetic screening; protein biomarkers; molecular biology;
bioinformatics and metabolomics
U.S. Dollars in Billions
12
10
8
6
40%
CAGR
10 B
4
2
1.8 B
0
2019
2014
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics
Year
Source: Criterion Bioscience
Report 2015
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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 chromatographymass 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
Allows physicians to detect carcinomas before they are symptomatic and visible
*Spermidine/Spermine Acetyltransferase
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics
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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 postsymptomatic stages
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics
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Methods of Amantadine Detection
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
Amantadine is the preferred substrate for SSAT
(activity of SSAT to substrate)
Pancreatic
Cancer Cells
Normal
Pancreatic
Cells
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
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Signatures Diagnostic Assay
SSAT1 Breast Cancer – Various Grades and Stages
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 Glioblastoma – Various Grades and Stages
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics
Source: BioMark Diagnostics Inc.
9
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 SSAT1Amantadine assay
Future detection of various stages of breast,
prostate, colorectal, glioblastoma, and ovarian
cancers
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics
Source: BioMark results conducted at BRI Canada
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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
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Product Development Pipeline
Up to 6 months
Planning
Development
U.S.
Approval
Market
SSAT-Amantadine Assay using LC/MS
Data points collected and validated
Transferable to FDA
SSAT-Amantadine Assay using ELISA Kit
In collaboration with
Kestrel Sciences to begin validation
SSAT-Amantadine Assay using
Raman
Polyamine
Pathway
Validation
Lung Cancer Metabolic
Fingerprint
Other Cancer
Fingerprints
Developing N-acetylamantadine
separation chemistry
Data collection - all lung cancer stages
Prostate, Breast, Cervical,
Ovarian, CRC, GI in architecture
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics
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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
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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
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Regulatory Timelines – Health Canada and FDA
Trials
Expected Timing
220 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
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Competitive Landscape – Ultra-Early Detection
Company
BioMark
Diagnostics
Biomarker
Cancer Diagnostic
Pre-Visible
Tumor
Detection
PreSymptomatic
Tumors
Development
Stage
Broad coverage
N-acetylamantadine
Lung, breast, melanoma,
GI, prostate
YES
YES
Market
NA
YES
Preclinical
YES
YES
Liver: Market in
2016
YES
NO
Preclinical
NA
NA
U.S. Market
Broad coverage
Cellmid Ltd.
Midkine
Matrix-Bio
VermarkerTM Liver
VeraMarkerTM Colon
Prostate, GI, stromal,
bladder, colorectal,
esophageal, thyroid,
pancreatic, bile duct
Broad coverage
Liver and Colon
Panacea
BioInformatics/
Analytical Approach –
Nuvera
Genetic, protein and
Broad coverage
(CRO) BioMark DIAGNOSTICS INC
metabolites
expression
profiles Powered by Metabolomics
A Next Generation
Company
16
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
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Strategy to Build U.S. Presence
• 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
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics
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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
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Scientific and Supporting Board
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
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
20
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
BioMark DIAGNOSTICS INC
A Next Generation Company Powered by Metabolomics
21