biomark diagnostics inc · 2016. 7. 10. · biomark diagnostics inc a next generation company...

BioMark DIAGNOSTICS INC

A Next Generation Company Powered by Metabolomics 1


A Next Generation Company Powered by Metabolomics

June 2016

OTC: BMKDF

CSE: BUX

www.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 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



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



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



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




• 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



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



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 - 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 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



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



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



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’s Clinical Utility



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



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



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



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



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)



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



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




• 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

biomark diagnostics inc · 2016. 7. 10. · biomark diagnostics inc a next generation company...

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