C OMMERCIALIZING P ROTEIN M ICROARRAY D IAGNOSTICS C ALENDAR Q2 2014 - - PowerPoint PPT Presentation

COMMERCIALIZING PROTEIN MICROARRAY DIAGNOSTICS

CALENDAR Q2 2014

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

• perations. 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

• f 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.

DISCLAIMER AND FORWARD LOOKING STATEMENTS

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TSX-Venture: SQD Shares outstanding: 56,336,058 Market Cap: ~27 M 52 week high/low: $1.14 - $0.42 Expected burn: ~$4M in F2014

SQI DIAGNOSTICS

Unique dual-layer protein microarray tests Growing test menu with FDA pedigree Products address critical issues

• f Global Pharmaceutical

companies 4 Global Pharmas signed on as customers in 2013

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SQI Diagnostics was founded in 1999 on the simple idea that the number of blood tests performed to diagnose a patient was large and growing and that reducing the effort to complete these multiple tests would create a significant benefit. SQI has invested over $45 million dollars to develop products and automated systems that enable customers to produce many test results simultaneously saving them time and money (“multiplexing”) while delivering the technical performance they demand. SQI targets two large markets: (1) Diagnostic testing laboratories and (2) Drug development companies (Global pharmaceutical companies and biotechnology companies) Our target pharmaceutical development customers have publically presented the superior technical performance of our products and compared this performance to competing and current test technologies. Our tests significantly decrease the total cost of delivery for drug development programs and diagnostics testing laboratories by running numerous test simultaneously, reducing total labour costs. Since mid-2013 we have signed four Master Service Agreements with some of the globe’s largest pharmaceutical companies to evaluate our drug development testing products. We have completed prototypes under each of these agreements, each in a matter of weeks. We have since converted two of these initial evaluations into paying customers and are confident of converting the remaining two as we also continue to make progress winning new customers. We continue to develop and file for approval of our in vitro diagnostic tests targeting diagnostic testing labs. We estimate that labour reductions alone could decrease the cost-base of processing tests using our products by much as 40% in a market comprised of mare than 1,000 US-based labs.

SQI Overview

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sqid™ Analyzers and Ig_plex™ Protein Microarrays

SQI DIAGNOSTICS

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We sell a range of fully automated analyzers (sqid-lite above), standardized and custom products as well as product development and testing services

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

COMPLEX PROTEIN ANALYSIS DEMANDS BETTER TOOLS

Does the patient have low estrogen? Today’s customers are demanding more…more test, more data. What are the patient’s levels of testosterone, estrogen (estradiol, estrone, estriol), progesterone, prolactin, IGF-1, homocysteine, cortisol/cortisone ,follicle stimulating hormone, luteinizing hormone, human growth hormone. What if these could be done all at the same time - one test, many results?

From qualitative tests…

ELISA

(enzyme-linked immunosorbent assay)

The gold-standard manual test for protein detection currently performed as single tests today – one test, one result

…to quantitative panels

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SQI CAN - SIGNIFICANT LABOUR AND TIME SAVINGS Saved time and decreased costs, with superior technical performance

Standard ELISA

(manual operation)

SQiDlite

(fully automated – multiplexed results) 32 Minutes of Labour / Patient to produce 8 results 30 Seconds of Labour / Patient to produce 8 results

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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

• Nearly eliminates labour
• 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 CUSTOMERS

Shift to multiplexed, automated tests significantly reduces time and labour

Example: Clinical Immunogenicity Test for Global Pharma/CRO:

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30 employees x 20 days 2 employees x 5 days

IG_PLEX™ BMS ANTI-DRUG ANTIBODY ASSAY

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Reference: 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

SQID ANALYZERS SIZED TO MEET DEMAND

SQiDworks SQiDlite SQiD-X Throughput 1000+ results / hour 300+ results / hour 200+ results / hour Size Foot Print 36" x 66" Bench Top 20" x 48" Bench Top 18" x 24" Target Customer Top 1,000 high volume reference laboratories Top 5,000 laboratories Research / non-IVD laboratories Hands-on Time for 1 Plate 15 minutes 15 minutes 45 minutes

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Drug Development Companies

SQI’S COMMERCIALIZATION STRATEGY

Four Global Pharma agreements signed in 2013

• 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 drug developers

• Provide “CRO”

services

• Develop increasingly

proprietary and valuable tests

• Develop companion

diagnostics

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RAPID COMMERCIALIZATION SUCCESS IN 2013

Agreement Drug candidates Global Pharma 1

• Master agreement signed
• 11-plex ADA assay development complete; evaluation

complete

• 21-plex Epitope Mapping assay under PAID development

in first half of 2014 1 of 33 Global Pharma 2

• Master agreement signed
• 21-plex ADA assay development complete
• 8-plex cytokine assay development complete; evaluation

underway 1 of 25 Global Pharma 3

• Master agreement signed Q4 2013
• 6-plex ADA assay development and evaluation complete;
• 2nd phase agreement being finalized to run pre-clinical

samples at SQI (current quarter) 1 of 20 ISIS

• Master agreement signed Q4 2013
• 8-plex ADA assay evaluation complete;
• Currently finalizing first commercial contract with its CRO

1 of 34

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POTENTIAL SOURCES OF PHARMA CUSTOMER REVENUE

Development Services Platform purchases Validation test purchase Pre-clinical test purchases Clinical test purchases Potential revenue unique to each drug under development; path to additional drug candidates Platform purchases Validation test purchase Clinical test purchases High volume tests conducted at central labs; potential revenue per customer Custom ADA panels and Epitope Mapping panels Biomarker panels (Cytokines, etc.)

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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 Quantitiative Test Anti-tissue transglutaminase IgA & IgG Anti-deamidated gliadin IgA & IgG FDA Filed Cleared by Health Canada 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 15

EXPERIENCED EXECUTIVE TEAM

Name Title Previous Affiliations

Andrew Morris CEO James Smith VP, Corporate Development Kate Smith VP, Technology Jaymie Sawyer VP, Assay R&D Russ Peloquin VP, Sales & Marketing Patricia Lie Director, Finance & Admin Peter Lea Founder

45 Publications; 40 Patents

Claude Ricks Chairman /BDO

LIFE SCIENCES

WWW.SQIDIAGNOSTICS.COM

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