biomark diagnostics inc a next generation company powered by metabolomics 1 biomark diagnostics inc...

BioMark DIAGNOSTICS INC

A Next Generation Company Powered by Metabolomics 1


A Next Generation Company Powered by Metabolomics

Rodman & Renshaw Global Investment Conference

September 9, 2015

OTC: BMKDFwww.biomarkdiagnostics.com



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.



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



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



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 - 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 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



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



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.



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



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



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



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



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



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



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



Potential Revenue Streams

Sales of products / supplies

Royalty on lab analysis (per test)

Licensing – Territorial and distribution licensing

Services• CDx for drug companies



• 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



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



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



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 1 biomark diagnostics inc...

Documents

generation company

combiomark diagnostics

new cancer therapeutics

biomark new paradigm

ultraearly cancer detection

company overviewwhy

oncologyfocused company

total diagnostic market