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March 2016 INFECTIOUS DISEASE DIAGNOSTICS [email protected]

Fusion Genomics Summary for Public - 14-Mar-16

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Page 1: Fusion Genomics Summary for Public - 14-Mar-16

March 2016

I N F E C T I O U S D I S E A S E D I A G N O S T I C S

[email protected]

Page 2: Fusion Genomics Summary for Public - 14-Mar-16

The holy grail of infectious disease management

To prevent individual mortality while circumventing drug resistance (due to antibiotic overuse) for the local, national and global populations.

Current MDx for infectious diseases

Either lack sensitivity and require lengthy (up to 3 months) pathogen cultivation ORProvide inadequate genotype information further contributing to antibiotic misuse & drug overuse.

Fusion Genomic’s Mission

Develop highly sensitive and massively multiplex DNA/RNA sequencing based diagnostics. We seek to change the paradigm in both treatment of the individual (optimum genomic information for effective personalized therapy) and public health (reduction in antibiotic overuse; information for development of transmission dynamic models, outbreak predictions & optimal vaccines).

1. The Need and Our Mission

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2. Current MDx Limitations• Indirect Results

• Dozens of Tests

Accuracy

• Limited Multiplexing

• Weeks to Months

Time

• Ineffective Treatment

• Increased Hospitalizations

Cost

Infectious diseases are a major cause of global morbidity and mortality. Lack of timely and accurate laboratory diagnosis of the infectious agents contributes to increase in disease burden, hospitalizations, mortality and drug resistance. Diagnosis of infectious agents using current PCR based laboratory tests have their limitations:1. Require multiple rounds of PCR based tests run

simultaneously or complex diagnostic modalities caused by array of pathogens.

2. Lack the sensitivity to differentiate among strains, virulent or otherwise.

3. May be unable to identify the pathogen directly from bodily fluids (blood, sputum, swabs). Hence proper diagnosis requires weeks long microbial culturing in a Level III biohazard facility.

4. Similarly, they provide inadequate genomic information which may be needed for new therapies and/or are unable to detect antimicrobial resistance and require culturing.

• Limited Capacity

• No Disease Modeling

Information

Example: Influenza genotype testing standard requires 22 different tests, along with cumbersome Sanger sequencing.

Example: Tuberculosis test can only identify one resistance gene and thus requires culture.

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3. Our Solution - The ONETest Our ONETest system utilizes Next Generation

Sequencing (NGS) machines and consist of our patent pending DNA/RNA capture technology, called Quantum Probes, combined with Fusion Cloud for analysis.

ADVANTAGES: High Sensitivity – ability to detect disease

when it is present in minute quantity in the sample (less than 0.1ng). This enables a ONETest to detect disease direct from patient sample at a very early stage and also enables our assays to pick up environmental DNA.

High Specificity – diagnosis from direct reads of the disease vector. Diversity Capture – a ONETest can be developed to capture a wide variety of organisms,

strains and quasi-species. This enables indication based versus disease specific assays. Detailed Data – with large percentage of disease genomes captured and thus virulence /

resistance info provided. Epidemiology/Eradication – the detailed data from a ONETest can be combined with

other data (geo-tags, climate) for disease surveillance and eradication. Cost Effective - capture actionable data at par with meta-genomic sequencing at low cost.

• Direct DNA evidence• Multi-parameter testing• Faster• Standardized protocol• Cheaper• More relevant

information• Multiple diseases ONE

test

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4. ONETest ApplicationsO

NET

est (

Qua

ntum

Pr

obes

& F

usio

n Cl

oud)

Diversity Capture

Multiple Organisms ONETest

Human flu

Upper Respiratory viruses

Sepsis

Hemorrhagic fever

Identify Quasi-species & Latent

infectionsHepatitis C virus

High Sensitivity & Specificity

Reduce initial detection window

Blood screen

MDR/XDR TB

Human papilloma virus

Environmental screening

Bird flu

Soil microbiomes

Technology Advantages Applications Products

Govt./ Surveillance

Govt./ Surveillance

Govt./ Surveillance

Surveillance Commercial

Patient Diagnosis

Patient Diagnosis

Patient Diagnosis

Patient Diagnosis

Patient Diagnosis

Patient Diagnosis

Market

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5. A Data Driven Approach Fusion Genomics’ approach to

diagnostics begins with building a database of all published genomes of the disease(s) of interest. This database is annotated with all published research and augmented with rare genomes from our partner(s).

This proprietary database is then used to develop the machine-learning based Quantum Probes for the disease and the analysis algorithms for the Fusion Cloud.

The Quantum Probes are paired with various reagents and optimized to a fully developed ONETest.

The ONETest paired with the Fusion Cloud can detect and genotype the disease(s) with very high sensitivity and specificity thus enabling precision therapeutics.

The analyzed genomes can be paired with other data such as geo-tags and analyzed to provide transmission models and tracking.

The data also further augments our database for better probe design.

ProprietaryDatabase

Quantum Probe

Data Analytics (FusionCloud)

Precision Therapeutics

Transmission Dynamics &

Tracking

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Fusion Genomics Corp. Confidential

Technology Overview Quantum Probes are synthetic DNA

molecules engineered to capture highly variable DNA with maximum sensitivity (up to 1,000x existing MDx) and specificity (>99%).

The Fusion Cloud complements Fusion’s MDx by identifying pathogen and their sub-types with >99% accuracy.

The capture efficiency of a Quantum Probe and Fusion Cloud powered assay is demonstrated by the phylogenetic tree, right, showing the strain diversity of H1 in Influenza virus captured by Quantum Probes as compared to RT-PCR assay.

The Fusion Cloud data feeds back to our proprietary genomics databases and enable better probes design to enhance capture efficiency.

INTELLECTUAL PROPERTY (IP) STATUS As Quantum Probes are entirely

engineered and have no counterpart in nature, they can be covered under IP. A provisional ‘change of phase’ patent has been filed in the US covering Quantum Probes. The Fusion Cloud will be kept proprietary and will be available on cloud platform or ‘black box” basis only.

6. Technology Overview

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7. ONETest Sensitivity Experiment

approx. Ct = 32

approx. Ct = 32

Fusion Genomics Corp. Confidential

High sensitivity of Fusion’s technology is shown through a serial dilution experiment on the Influenza ONETest.

The graph to the right shows the mean read coverage of HA and NA segments of the Influenza genome based on starting material.

The serial dilution experiment proves that even with 0.1 nano-gram of material where RT-PCR begins to fail, the Fusion assay is giving 2,000+ reads.

The sensitivity of a ONETest thus approaches 1,000x of RT-PCR

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The Quantum Probes based Influenza ONETest identifies type A/B influenza, targets all 198 genotypes and provides detailed strain information and genomic data in one test for influenza surveillance & outbreak tracking.

Current influenza genotype testing standard requires 22 different tests, along with cumbersome Sanger sequencing.

The World Health Organization estimates – “the average global burden of inter-pandemic influenza may be on the order of ~1 billion cases of flu, ~3–5 million cases of severe illness and 300,000–500,000 deaths annually”. The more comprehensive data of the Influenza ONETest holds the

promise of a more effective vaccine. The total addressable market for an Influenza

surveillance genotyping test is over US$ 19 million per annum. The market is easy to capture compared to other clinical markets as there are only a small number of technically inclined buyers.

The test was developed in collaboration with and has been validated by a major reference lab in BC. The data proved that the Influenza ONETest is the is much more sensitive than existing PCR methods and gives detailed strain-level data.

The test is also undergoing a 100 sample pilot at a major European WHO reporting center.

9. Current Product: InfluenzaTable: Projected 2016 Worldwide Influenza Genotyping Tests

Test Volume

(Number)Rate

(USD/Test) Value (USD)USA 34,560 175 6,048,009Canada 12,367 150 1,855,091EU 12,209 175 2,136,649Rest of the World 61,789 150 9,268,376Total 120,926 19,308,126Source: WHO FLUNET Data and Fusion Estimates

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As part of a multi-million dollar pan-Canadian effort to detect and predict bird flu outbreaks, Fusion Genomics in collaboration with the Government organizations and a reference lab in Canada, tested our technology for the isolation and sequencing of bird flu RNA from wetland sediments in wild bird habitats.

The results showed that only Quantum Probes were able to capture and detect the bird flu HA and NA genes for sequencing. It should be noted that simultaneous testing by PCR based sequencing methods failed to give any results.

The project is now entering Phase II; to evaluate Avian Influenza eDNA ONETest and Fusion Cloud as a comprehensive testing regiment to be used by Canada and its international partners.

10. Current Product: Avian eDNA

The ability of ONETest to capture and sequence environmental/soil samples has major implication for use of such tests in agriculture. Soil based micro-biomes, which could be analyzed using our technology, are expected to play a major role in advancing food production.

Wild bird migratory paths requiring surveillance

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The Hepatitis C (HCV) ONETest has an estimated USD 1.5 billion plus global market. The assay is starting external validation and has been designed to give comprehensive genotyping and viral load data.

Current HCV PCR tests are sub-optimal as they do not give data on existing minority genotypes of HCV in patients, do not cover all sub-types or identify quasi-species and give inadequate data for public health purposes.

The Hepatitis C ONETest not only provides detailed clinically relevant information (quasi-species, minority strains) but also information that is essential to develop transmission dynamic models necessary for disease control and eradication efforts.

Using the test Fusion was able to capture an as yet un-reported Type 3b genome of Hepatitis C that demonstrates the power of the test.

Fusion’s Hepatitis C ONETest is being evaluated by the diagnostic division of a major multi-national.

Due to high sensitivity of Quantum Probes, the test is expected to be able to detect Hepatitis C at a very early stage of the disease that would be very helpful in screening blood donors and could also improve clinical outcomes.

11. Current Product: Hepatitis CTable: Estimated 2013 Hepatitis C Genotyping & Viral Load Tests

Test Volume

(Number) Rate (USD/Test) Value (USD)USA 489,435 110 53,837,850Canada 177,778 70 12,444,460EU 611,794 110 67,297,313Rest of the World 23,314,048 60 1,398,842,879Total 24,593,055 1,532,422,501Source: Howe Sound Research and Fusion Estimates

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The Fusion Cloud is based on a fully annotated proprietary database developed at Fusion Genomics and contains over 1.0 M infectious disease genomes as well as rare pathogen genomes from our partners and collaborators.

The cloud analysis software is able to identify thousands of genomic variants from NGS sequencing data.

A fully functional web-based GUI is expected by end-March 2016 with a finalized software launched in June 2016.

The software (with some modification) can form a standalone product for researchers & clinicians wishing to identify specific organisms in whole meta-genome data sets

The software address a significant barrier for the adoption of NGS based diagnostics by eliminating upfront costs for expensive computational biologist and infrastructure.

12. Cloud Analysis Products

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13. ONETest Product PipelineProduct Impact

Upper Respiratory Disease ONETest

Identify specific organism causing long running upper respiratory disease thus enabling tailored therapies.

Blood Screening Multiplex ONETest

Detection of blood borne diseases (eg HIV, HepC) at much earlier stages thus making blood supply even safer.

MDR/XDR Tuberculosis ONETest

Confirms Tuberculosis and identifies the drugs to which the disease is resistant. Quicker treatment of MDR/XDR variants and reduces overuse of standard TB drugs.

Human Papilloma ONETest

Identification of specific cancer causing strains of HPV earlier to drive a paradigm shift in cervical cancer incidence.

Sepsis ONETest Identification of exact strain causing sepsis and its resistance profile within 24 hours thus reducing mortality from hospital infections.

Leptospirosis ONETest

Identify all variants of Leptospirosis thus reduce mis-diagnosis of this disease which has a disproportionate impact on low income countries.

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The Influenza ONETest is undergoing a 100 patient pilot with a major reference center in the Netherlands for 2016 influenza season genotype reporting to the WHO. A successful pilot will lead to additional sales and EU-wide use of the test.

The recent pilot with the Government organizations in Canada proved that the technology is successful in genotyping bird flu from environmental samples. The pilot is now being expanded to full scale Canada-wide trial of using environmental DNA for surveillance of bird flu which involves sales of 3,000+ test kits. This could also lead to routine annual surveillance of bird flu using the Avian Influenza eDNA ONETest.

14. Market Validation & Traction

Fusion is also in talks with the a major reference lab in BC for a 2,000 sample retrospective study of Hepatitis C to generate data for regulatory approval.

Fusion Genomics is also leveraging Chinese angels who invested in the company to develop links with Chinese businesses. Fusion has had exploratory meeting with businesses in China, Hong Kong and Singapore.

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15. Key Management TeamDr. Mohammad Qadir, President & Chief Scientific OfficerLed the spinoff of Fusion from the BC Cancer Agency where he worked with world-renowned experts in genomics and drug development. Oversees all the scientific aspects of R&D at Fusion and serves as the interface for all collaborators.

Gregory W. Stazyk, Chief Technical OfficerHas over 25 years of experience and served as the IT lead of one of Canada’s largest bioinformatics platforms at the Genome Science Center where he expanded the infrastructure from a few dozen core-machines to over 10,000 in the core cluster in a CAP/CLIA environment.

Brian Kwok, VP Product DevelopmentHas over 10 years of experience in genomic technologies including leading edge NGS. He was actively involved in developing molecular diagnostic assays in leading labs in Netherlands and Canada. Brian is responsible for the development of Fusion’s new assays.

Shing Zhan, Bio-Informatics LeadHe has proven expertise in computational biology, especially in the analysis of NGS data, and in the development of bioinformatics and statistical methodologies with 13 scientific articles in journals such as Science and the American Journal of Human Genetics.

Akmal Jameel, CFA, Chief Financial OfficerHas over 25 years of experience in transaction support, PE & VC investments and fund raising. He has participated in over US$ 1 billion of transactions and has board level experience in a number of companies. Fin tech startup experience in frontier mkt as CEO.

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16. Contacts and DisclaimerAkmal Jameel, CFA Mohammed Qadir, PhD

Chief Financial Officer President and CSO

[email protected] [email protected]

Room 221-224, Discover 2, 8900 Nelson Way, Simon Fraser University, Burnaby, British Columbia, V5A 4W9, Canada

Tel: +1 (604) 428-7701

This document has been prepared by Fusion Genomics Corp. from sources believed to be reliable, however no representation or

warranty, express or implied, is made by Fusion Genomics, its affiliates or any other person as to its accuracy, completeness or

correctness. Neither the information provided nor any opinion expressed constitute an offer to sell or a solicitation of an offer to buy

any securities or to take any deposits or provide any financing. Investment in Fusion Genomics Corp. will be made by subscription in

accordance with the regulations and rules of the BC Securities Act. Past performance is not a guide to future performance, future

returns are not guaranteed, and a loss of original capital may occur. Prospective investors are advised to obtain independent legal,

accounting, tax and investment advice regarding the suitability of an investment in Fusion Genomics Corp.