INVESTOR PRESENTATION 2014 · RAPID COMMERCIALIZATION SUCCESS IN 2014 Agreement Drug candidates...

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INVESTOR PRESENTATION 2014

Transcript of INVESTOR PRESENTATION 2014 · RAPID COMMERCIALIZATION SUCCESS IN 2014 Agreement Drug candidates...

Page 1: INVESTOR PRESENTATION 2014 · RAPID COMMERCIALIZATION SUCCESS IN 2014 Agreement Drug candidates Global Pharma 1 1. 11-plex ADA assay – evaluation complete 2. 21-plex Epitope Mapping

INVESTOR PRESENTATION 2014

Page 2: INVESTOR PRESENTATION 2014 · RAPID COMMERCIALIZATION SUCCESS IN 2014 Agreement Drug candidates Global Pharma 1 1. 11-plex ADA assay – evaluation complete 2. 21-plex Epitope Mapping

This presentation contains forward-looking statements. Forward-looking statements include statements

regarding the Company’s future financial position, business strategy, projected costs, strategic partnering,

regulatory actions, the capabilities of the Company’s platform, and plans and objectives of management for

future operations. These forward-looking statements are based on the Company’s current expectations and

beliefs, as well as a number of assumptions concerning future events. Typically, these statements contain

words such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan,” and similar

expressions. These statements are subject to risks, uncertainties, assumptions and other important factors,

many of which are outside of the Company’s control, that could cause actual results to differ materially from

the results discussed in the forward-looking statements – including, but not limited to, the extent of our future

losses, our ability to develop and market our products, development or commercialization of similar products

by our competitors, and our ability to comply with applicable governmental and securities regulations and

standards. You are cautioned not to place undue reliance on such forward-looking statements because actual

results may vary materially from those expressed or implied. All forward-looking statements are based on

information available to the Company on this date and, except as required under applicable law, the Company

assumes no obligation to, and expressly disclaims any obligation to, update or revise any forward-looking

statements, whether as a result of new information, future events or otherwise.

FORWARD LOOKING STATEMENTS

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Page 3: INVESTOR PRESENTATION 2014 · RAPID COMMERCIALIZATION SUCCESS IN 2014 Agreement Drug candidates Global Pharma 1 1. 11-plex ADA assay – evaluation complete 2. 21-plex Epitope Mapping

SQI DIAGNOSTICS

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mul·ti·plex ---- verb ---- /‘məl-tē -, pleks/ -to detect multiple analytes from a single biological specimen

one well one unit of effort multiple results

the pain is cost, the cure is multiplexing and automated analyzers from SQI

using only 15 minutes of labour, our products and systems

deliver full panels of up to 3,000 quantified results reducing labour by 90%

maintaining quality and performance in every result

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VALUE PROPOSITION:

SIGNIFICANT LABOUR AND TIME SAVINGS

Save time and reduce costs, with superior technical performance

Standard ELISA (manual operation)

sqidliteTM

32 Minutes / Patient 30 Seconds / Patient

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SQI’S CORE BUSINESS FOCUS

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Big Pharma / Big Biotech Custom and routine

high-volume assays for clinical drug development

Reference Laboratories Regulatory cleared

In-Vitro Diagnostic (IVD) assays for disease diagnosis

and monitoring

Our automated platforms, certified products and custom assay development services satisfy an unmet need in two distinct life sciences markets

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TSX-V: SQD

OTCQX:SQIDF

Shares outstanding: 56,336,058

Market Cap: ~$20 M

52 week high/low: $0.90 - $0.31

Expected burn: ~$4M in F2015

All figures in CAD unless otherwise stated.

SQI DIAGNOSTICS

Unique dual-layer protein microarray tests

Growing test menu with FDA

pedigree

Products address critical issues of Global Pharmaceutical

companies

5 Global Pharmaceutical

Companies signed on as customers

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Founded in 1999 on the simple idea that reducing the number of blood tests performed to diagnose a patient would create a significant benefit.

Invested over $45 million in Research and Development since then.

Target markets: (1) Diagnostic testing (Clinical and Animal Health) and (2) Diagnostic Tools and Services to Drug development companies.

Running our tests simultaneously could cut total costs by 40% in a market comprised of m0re than 1,000 US-based labs.

Six Master Service Agreements with some of the globe’s largest pharmaceutical companies.

Completed prototypes under each of these agreements, each in a matter of weeks.

We continue to develop and file for approval of our in vitro diagnostic tests targeting diagnostic testing labs.

SQI Diagnostics Overview

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Proteins are big, sticky, and don’t play well together

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UNIQUE DUAL-LAYER PROTEIN MULTIPLEXING

IG_PLEX™

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The world's first multiplexing methodology that allows simultaneous quantitation of immunoglobulin isotype and subclass for multiple proteins

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COMPLEX PROTEIN ANALYSIS DEMANDS BETTER TOOLS

from qualitative tests… …to quantitative panels

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Shift to multiplexed, automated tests significantly reduces time and labor

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30 employees x 20 days 2 employees x 10 days

CLINICAL IMMUNOGENICITY

Test for Pharma/CROs

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VALUE PROPOSITION

SIGNIFICANT LABOUR AND TIME SAVINGS

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Cost Structure

Current Effort to Complete Testing Using ELISA

-20,000 samples

-32 mins/sample

-8 hrs per EE day

30 EEs

44 Days

+ Development of Multiple Single Tests

+Test Consumable Costs

SQI Automated Ig_PLEX

-20,000 samples

-0.5 mins/sample

-8 hrs per EE day

2EEs

~10Days

+Test Consumable Costs

Savings to Laboratory Using SQI Ig_PLEX compared to current

~1300 man-days

>~$320,000

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RECENT EXPANSION INTO MOLECULAR DETECTION

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Partner-lead, opportunistic project

19 pathogen/31 probe panel is SQI’s first molecular product for human and animal health applications

Based on re-usable (low cost) 3D polymer microarray capable of detecting 384 targets

First contract to develop a proof of concept automated detection capability on sqidlite-dh has been successfully completed

Additional agreements expected to complete detection platform and scale-up of manufacturing

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Microbiology Culture

Direct PCR Sequencing & Gene Arrays

• Typically used as Gold Standard

• Forensics • Infectious disease • Higher order species

• Genome Mapping • Gene expression • Drug Discovery

Pathogen Array

• Few Targets • Low cost • Slow • Prone to No

Growths

• 1 target • Complex • High cost • Very Slow

• All targets in one well • Low cost • Very Fast

• Ideal for high volume • Polymicrobial & higher

order detection • Test can answer many

questions

• Few Targets • 1 target/reaction • Medium cost • Fast

PATHOGEN ARRAY POSITIONING

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SQI Advantage

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SQID ANALYZERS SIZED TO MEET DEMAND

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SQiDlite SQiD-X

Throughput 300+ results / hour 200+ results / hour

SizeBench Top20" x 48"

Bench Top18" x 24"

Target Customer

Top 5,000 laboratoriesResearch / non-IVD laboratories

Hands-on Time for 1 Plate

15 minutes 45 minutes

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COMPETITIVE OFFERINGS

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Traditional ELISA

Genalyte Meso Scale Discovery

Luminex SQI Advantage

Format Traditional ELISA

sandwich on plastic: chemi/fluor/color

An array of Microring Sensors constructed

from silicon photonics technology

Biotin/streptavadin capture sandwich spots on carbon: electrochemiluminescence

Capture sandwich spots on beads; fluorescence

Covalent capture assay sandwich spots on activated

glass; fluorescence

Multiplex capability

X None

√ - By capture protein only

- By capture protein only

√ By capture proteins,

isotypes, and subclass

Relative reproducibility

(CV%)

Benchmark X Worse

X Worse

X Worse

√ Equivalent or better

# of discrete replicate tests

X 128 (per consumable)

X X

None (too many; increases crosstalk)

√ +30 per well

(3,000 per consumable)

Biomarkers per well

X One

One √ Up to 10

√ Up to 100 (Qualitative)

√ Up to 30 (Quantitative)

In-well QC controls

X None

X None

X None

X None

√ Flexible and configurable

to customer requirements

# of tests to validate

X For each biomarker

unknown -

One per isotype or subclass

- One per isotype or

subclass

√ One

Relative cost per result

$ unknown $$$$ $$$ $

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COMMERCIALIZATION STRATEGY

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Drug Development Companies

SQI’S COMMERCIALIZATION STRATEGY

Six Pharma agreements signed in 2013/14

• IVD RA test establishes Ig_plex™ product line

• IVD clearances validate QA/QC, manufacturing

• Drive laboratory customer adoption with expanding US sales force

• Expand menu of approved reference laboratory tests

Reference Laboratories

• IVD pedigree brings credibility to pharmaceutical customers

2009 - 2012 2013 2014 2015

• Co-develop tests in partnership with 5 drug developers

• Provide “CRO” services

• Penetrate routine screening and testing segments (cytokines)

• Develop increasingly proprietary and valuable tests

• Develop companion diagnostics

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Target: 8+ active in 2015

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RAPID COMMERCIALIZATION SUCCESS IN 2014

Agreement Drug

candidates

Global Pharma 1

1. 11-plex ADA assay – evaluation complete 2. 21-plex Epitope Mapping assay – validation planning

1 of 33

Global Pharma 2

• 21-plex ADA assay development complete 1 of 25

Global Pharma 3

• 6-plex ADA assay development and evaluation complete; 2nd phase agreement signed

1 of 20

ISIS • 8-plex ADA assay evaluation complete; finalizing first

commercial contract with its CRO 1 of 34

Global Pharma 4

1. Two 3-plex ADA assays under development for evaluation 2. High Volume bridging / screening assay under development

32 late-stage

DNA Customer

• 19 pathogen panel in dev/automation with demo mid-Sept • Related human LDT panel – commercial potential H1 2015

1 of 2

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FDA GUIDANCE = SQI PHARMA BUSINESS MODEL

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Immunogenicity and ADA testing requirements

Epitope mapping or more complete characterization of

immunogenic responses

Drug Tolerance of ADA Assays

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IG_PLEX™ BMS ANTI-DRUG ANTIBODY ASSAY

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Ref: Bristol-Myers Squibb Presentation, Bioassays and Bioanalytical Method Development Conference in Berkeley, CA, Oct 8, 2013

• Adnectin Fc Immunogenicity assay developed

focused on high sensitivity and drug tolerance

• Plate based assay format showed significant

increase in drug tolerance

• Assay was successfully developed at SQI with

increased sensitivity and drug tolerance while

providing additional isotyping data

• SQI assay was automated and qualified with high

reproducibility

Summary and Conclusions

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Pharma and Biotech Drug Developers

Sales focus on leads generated through direct selling, AAPS and conferences

2 AAPS working groups

Establishing CRO footprint – Goal: add one/quarter in 2015

Expand/monetize existing agreements

Adding 8 new agreements in 2015

IVD Market

Targeting top 500 reference laboratories in North America

Growing IVD sales force in 2015 and exploring strategic partnerships

Added to sales team in 2014 (East US - West US)

Active discussions with large, content-rich market leaders

SQI 2014 COMMERCIALIZATION AND SALES STRATEGY

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Page 24: INVESTOR PRESENTATION 2014 · RAPID COMMERCIALIZATION SUCCESS IN 2014 Agreement Drug candidates Global Pharma 1 1. 11-plex ADA assay – evaluation complete 2. 21-plex Epitope Mapping

ROBUST IVD PIPELINE OF INCREASINGLY VALUABLE TESTS

Test Candidate

Panel Insight

Proof of Concept

Assay Dev.

Automation Validation FDA

Regulatory Status

IgXPLEX™ Rheumatoid Arthritis Test RF-IgA, RF-IgM and anti-CCP-IgG

FDA Cleared

IgXPLEX™ Celiac Disease Qualitative Test Anti-tissue transglutaminase IgG & IgA

FDA Cleared

Celiac 4-plex Quantitative Test Anti-tissue transglutaminase IgA & IgG Anti-deamidated gliadin IgA & IgG

FDA Cleared

Vasculitis 3-plex Quantitative Test Anti-Myeloperoxidase IgG Anti-Proteinase 3 IgG Anti-Glomerular Basement Membrane IgG

Lupus 12-plex Quantitative Test

IBD Crohn's / UC 8-plex Quantitative Test

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CELIAC PERFORMANCE

Analyte Sensitivity

(%) Specificity

(%)

tTG IgA 98.4 100.0

tTG IgG 46.9 98.8

DGP IgA 79.7 99.2

DGP IgG 89.1 99.6

Clinical Sensitivity and Specificity

Analyte

Range of Coefficient of Variation (%CV)

Intra-Assay

(n=12)

Inter-Assay (n=80)

Lot-to-Lot (n=30)

Multi-Instrument

(n=90)

tTG IgA 1.9 - 4.8 5.3 - 6.9 4.5 - 6.8 5.5 - 8.6

tTG IgG 2.7 - 5.2 6.2 - 9.1 6.6 - 9.5 8.6 - 10.1

DGP IgA 2.2 - 6.3 4.8 - 7.7 4.7 - 9.4 7.5 - 9.6

DGP IgG 2.1 - 3.8 4.6 - 7.3 4.5 - 6.7 6.0 - 9.3

Precision and Reproducibility

Analyte Positive

Agreement (%)

Negative Agreement

(%)

Overall Agreement

(%)

tTG IgA 100.0 87.9 92.9

tTG IgG 94.1 84.6 86.3

DGP IgA 93.3 95.1 94.3

DGP IgG 98.5 90.3 93.6

Predicate Method Agreement

Received FDA Clearance for our Ig_plex Celiac DGP Panel for Sale in the US in November 2014

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SIGNIFICANT IVD CUSTOMER COST REDUCTIONS

Celiac 4-Plex Vasc 3-Plex Lupus 12-Plex

CPT Reimbursement* $58.22 $43.50 $276.00

Traditional laboratory cost per test $40 $30 $120

Savings to laboratory per test with SQI

$17.27 $12.95 $53.52

SQI Revenue per test $20.00 $14.00 $64.00

Median tests per year

(for the top 500 NA laboratories) 23,400 15,600 35,100

Revenue to SQI per year per laboratory

$468,000 $218,400 $2,200,000

* CPT Billing Schedule

1000 Target Reference Laboratories in North America

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Customized and outsourced test development

• Classify and quantify complete patient immune responses in a single test

• Report on multiple proteins, multiple immunoglobulin isotypes and subclasses simultaneously

• Conduct a side-by-side analysis of therapeutic proteins, drug metabolites, subunits and oligonucleotides

Reduces labour expenses

• Shortens time to regulatory filing

• Reduces costs

• Reduces valuable blood needed

• Systems exceed all FDA and EMEA immunogenicity and biosimilar testing guidelines

SQI PROVIDES TANGIBLE BENEFITS TO PHARMA

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Page 28: INVESTOR PRESENTATION 2014 · RAPID COMMERCIALIZATION SUCCESS IN 2014 Agreement Drug candidates Global Pharma 1 1. 11-plex ADA assay – evaluation complete 2. 21-plex Epitope Mapping

POTENTIAL SOURCES OF PHARMA CUSTOMER REVENUE

Development Services

$50,000

-$400,000

Platform purchases

$120,000

Validation test purchase

$200-$400 per

sample

Pre-clinical test kit

purchases 100’s kits

Clinical test kit purchases

1,000 – 10,000

kits

Potential revenue unique

to each drug under

development; path to

additional drug candidates

Custom ADA panels and Epitope Mapping panels

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+ higher volume, “routine” panels cytokines, pk assays

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EXECUTIVE MANAGEMENT TEAM

Name Title Previous Affiliations

Andrew Morris President and CEO

Kate Smith VP, Technology

Jaymie Sawyer

VP, Research & Development

Russ Peloquin VP, Sales & Marketing

Patricia Lie Director, Finance & Admin

Peter Lea Founder 45 Publications; 40 Patents

LIFE SCIENCES

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Page 30: INVESTOR PRESENTATION 2014 · RAPID COMMERCIALIZATION SUCCESS IN 2014 Agreement Drug candidates Global Pharma 1 1. 11-plex ADA assay – evaluation complete 2. 21-plex Epitope Mapping

APPENDIX

Page 31: INVESTOR PRESENTATION 2014 · RAPID COMMERCIALIZATION SUCCESS IN 2014 Agreement Drug candidates Global Pharma 1 1. 11-plex ADA assay – evaluation complete 2. 21-plex Epitope Mapping

Estimated $9.0 billion global non-IVD market

SQI's Dx Tools and Diagnostics Services address 20%+ of the non-IVD Market

Leveraging Core IVD Platform to Target Complementary Markets

Strategic Focus for SQI Dx Tools Business is $2.0B in US / EU

US Focused Non-IVD Dx Tools Market Segmentation Estimate $3.7B

U.S.

$3,690 41%

EU

$2,160 24%

Asia

$1,890 21%

RoW

$1,260 14%

Immunoassay$885 24%

Molecular

$369 10%

Blood Testing$332 9%

Chemistry$1,365

37%

Pathology$184 5%

Other

$553 15%

Source: Kalorama, Test Services Commercialization, 2008

Non-IVD Dx Tools Market Segmentation Global Estimate $9.0B

Note: USD millions

Multi Billion Dollar DX Tools Market Opportunity

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Page 32: INVESTOR PRESENTATION 2014 · RAPID COMMERCIALIZATION SUCCESS IN 2014 Agreement Drug candidates Global Pharma 1 1. 11-plex ADA assay – evaluation complete 2. 21-plex Epitope Mapping

Autoimmune$1,500

Infectious

Disease$2,405

Allergen$595

Heart$1,235

Cancer$1,305

Other

$500

Drug Testing

$2,760

Multi Billion Dollar IVD Market Opportunity

Autoimmune

$1,500 Infectious Disease$2,405

Allergen

$595

65% or $3.0B is represented by NA and

Europe

Source: Freedonia IVD Market Demand 2011

2012 Immunoassay Dx Test Market Strategic Dx Market Focus – $4.5B

Targeting Technically Challenging Markets and Established Reimbursement

Note: USD millions

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Core IVD Platform to Target High Volume Reference Labs

Page 33: INVESTOR PRESENTATION 2014 · RAPID COMMERCIALIZATION SUCCESS IN 2014 Agreement Drug candidates Global Pharma 1 1. 11-plex ADA assay – evaluation complete 2. 21-plex Epitope Mapping

CONTACT INFORMATION:

SQI DIAGNOSTICS INC.

36 METEOR DRIVE

TORONTO, CANADA M9W 1A

[email protected]

416-674-9500