INVESTOR PRESENTATION 2015
This presentation may contain certain statements including, without limitation, the words “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect”, “believe”, “in the process”, “benefits”, “leading to”, “possible”, “is subject to” and other similar expressions which may constitute “forward-looking statements” within the meaning of applicable securities laws.
Forward-looking statements reflect the Company's current expectations and assumptions, and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated. Readers are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements involve risks and uncertainties including, but not limited to: our ability to market and sell our products including our novel multiplexing technologies and detection platforms; our ability to maintain any technical or product advantages; the success of our Diagnostic Tools and Services business and our intent to build near-term revenue streams from this business; the successful regulatory filing and receipt of regulatory approvals for our later stage quantitative diagnostic kits; adverse changes in general economic conditions; international risk and currency exchange fluctuations; competitor activity; technology changes; regulatory approvals and the impact of healthcare reform legislation; and, SQI's ability to raise additional funds in the future.
Such statements, risks and uncertainties are detailed in the Company’s ongoing filings with the securities regulatory authorities, and are available to the public at www.sedar.com. The Company undertakes no obligation to publicly update or revise any forward-looking statements either as a result of new information, future events or otherwise, except as required by applicable securities laws.
FORWARD LOOKING STATEMENTS
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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 costs by 90%
maintaining quality and performance in every result
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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Anti-Drug-Antibody Screen
Anti-Drug-Antibody Isotype
Epitope Map
Vaccines - Efficacy
Vaccines – Serotype Map
Animal Health Diagnostics
Human Autoimmune Dx
Human Allergy Dx
Human Infectious Disease (DNA)
Animal Infectious Disease (DNA)
Autoantibody Dx
Biomarkers
Multiplexing
Human Diagnostic Multiplexing
FDA Cleared Qualitative & Quantitative Products
Pharma Drug Development & Custom Diagnostics
MULTIPLEX PLATFORM DEVELOPMENT
Combination Drug -pK
CORE BUSINESS FOCUS
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Diagnostics Tools and Services
Big Pharma / Big Biotech
Custom and routine
high-volume assays for
clinical drug development
IVD
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
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
US AND EU TREND IS PROVOKING MORE TESTING
SOURCES OF PHARMA CUSTOMER REVENUE
Development Services
$50,000
-$400,000
Platform purchases
$60,000
& $120,000
Validation test kit
purchases
Pre-clinical test kit
purchases 10’s of kits
or $200-$400 per sample
Clinical test kit purchases
100’s – 1,000’s
kits ~$1,800+
per kit
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, biomarkers
target revenue per platform is $1 to $2M
Device and Method for Analysing a Biological Sample
Methods for Multiplex Analyte Detection and Quantification
Method to Measure Dynamic Internal Calibration True Dose Response Curves
Array Fluorescence Equalization Method
SQI- CORE PATENT ESTATE
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Method and Device to Optimize Analyte and Antibiody Substrate
Method for Substrate Coated Micro-Array Supports
Methods and Device to Remove Fluid and Vapor
Dryer for Analyzer/Drying Mulit-well Assay Device
Core Multiplexing
Multiplexing Devices - Microarrays
Microarrays – Processing Arrays
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
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 $$$$ $$$ $
COMMERCIALIZATION
CASE STUDY
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
RAPID COMMERCIALIZATION SUCCESS IN 2014
Agreement Drug
candidates
Global Pharma 1
1. 11-plex ADA assay – evaluation complete 2. 21-plex Epitope Mapping assay complete 3. Platform delivery complete – evaluation on-going 4. 2-3 additional drug projects in work-planning stage
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Global Pharma 2
• 21-plex ADA assay development complete/holding 1 of 25
Global Pharma 3
• 6-plex ADA assay development and evaluation complete; • 2nd phase agreement signed • CRO services started in Q2
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 3. Planning additional projects for 2015 (ADA, vaccine and pK)
32 late-stage
DNA Customer
• 19 pathogen panel in dev/automation • sqidlite-DH proof of concept complete, 6th dev agreement pending • Related human & 31 plex panel – commercial potential in 2016
2 of 2
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Commercialization Scorecard
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Prospect
Sales
Meetings
Project
Work
Plan
Proof of
Concept &
Test DevelopmentPlatform
Automation
Pre-Clinical
Testing
Services /
Kit Sales
Platform
Placement
Evaluation Pu
rch
ase
On-Going
Kit Sales
Global Pharma Customer 1
Project 1 : 11-PLEX ADA
Project 2 : 21-PLEX Epitope Map
Project 3 : ADA ProjectProject 3 : West Coast ADA Project
Global Pharma Customer 2
Project 1 : 21-PLEX ADA
Global Pharma Customer 3
Project 1 : 6-PLEX ADA
Project 2 : ADA
Global Pharma Customer 4
Project 1 : 3-PLEX ADA Screening agreement pending
Project 2 : 3-PLEX ADA
Project 4 : 6-Plex Pk Combination Tx
Project 3 : 24-PLEX Vaccine
ISIS/Algorithme
Project 1 : 8-PLEX ADA
Global Animal Health Diagnostic Customer
Project 1 : 3-PLEX Viral Proof of Concept
Project 2 : XX-PLEX Viral Panel
DNA Diagnostic Customer 2
Project 1 (Human Infection - DNA)
Project 2 (Animal Infection - DNA)
“Emerging Technologies Focus on Immunogenicity,” at National Biotech Conference 2014, by Valerie Theobold, Sanofi
“Immunogenicity Assay Considerations,” at Bioassays and Bioanalytical Development Conference 2013, by Jochem Gokemeijer, Bristol-Myers Squibb-Adnexus
“Impact of Circulating Drug on Measuring Anti-Drug Antibodies,” at Immunogenicity & Immunotoxicity Conference 2015, by Xiao-Yan Cai, Merck & Co.
“SQI: Application of SQI Multiplex Platform in immunogenicity Testing - Epitope Mapping and Isotyping,” WRIB April 2015, by Renuka Pillutla, Bristol-Myers Squibb
“Understanding the impact of Immunogenicity: Assessment, Effects on biotherapeutics and strategy for Immunogenicity Testing,” WRIB April 2015, by Linlin Luo, Bristol-Myers Squibb
“Understanding the Impact of Immunogenicity: Assessment, Effects on Biotherapeutics and Strategy for Immunogenicity Testing,” Immunogenicity for Biotherapeutics Conference, by Lora Hamuro, Bristol-Myers Squibb, April 2015
Emerging Technologies Matrix Interference Task Force paper, 2015, American Association of Pharmaceutical Scientists (AAPS) – SQI is a task force member
Emerging Technologies Action Program – Immunogenicity and Multiplexing , 2014/2015 American Association of Pharmaceutical Scientists (AAPS) - SQI is a working group member
INDUSTRY VALIDATION
IVD PIPELINE OF INCREASINGLY VALUABLE TESTS
Test Candidate
Panel Insight
Proof of Concept
Assay Dev.
Automation Validation FDA
Regulatory Status
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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MANAGEMENT TEAM
EXPERIENCED EXECUTIVE TEAM
Name Title Previous Affiliations
Andrew Morris CEO
Jaymie Sawyer VP, Assay R&D
Russ Peloquin VP, Sales & Marketing
Aye Nyein San Director, Platform Engineering
Lennie Ryer CFO
Peter Lea Founder 45 Publications; 40 Patents
LIFE SCIENCES
BOARD OF DIRECTORS
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Name Title Affiliations
Clive Beddoe Chairman of the Board Founder and Chairman of WestJet Airlines
Wil Matthews Director Past Vice-Chairman and Director BMO Nesbitt Burns; current Director WestJet Airlines
Gerald Connor Director Chairman, Cumberland Private Wealth Management
Cameron Prange Director, Chair Audit Committee
Founder and President Kingsdale Capital Markets
Claude Ricks Director Past CEO SQI, currently COO gshift labs
Eric Schneider Director Partner, Miller Thompson
Andrew Morris President and CEO, Director 11 years with SQI
TSX-V: SQD
OTCQX:SQIDF
Shares outstanding: 56,386,058
Market Cap: ~$30 M
52 week high/low: $0.27 - $0.71
Expected burn: ~$5.5M in Fiscal 2015
Significant Shareholders
All figures in CAD unless otherwise stated.
SQI- CORPORATE FINANCE
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SQI Provides Tangible Benefits to Pharma
Reduce labour expenses
Shortens time to regulatory filing/to a “no go” decision
Reduces total cost of delivery
Reduces valuable blood needed
Systems exceed all FDA and EMEA immunogenicity and biosimilar testing guidelines
Report on multiple proteins, multiple immunoglobulin isotypes and subclasses simultaneously
Provide technology platform to leverage investment for running routine products / biomarker tests
SQI Commercialization Milestones
Place sqidlite/sqid-X platforms and generate commercial revenues in Pharma & Custom Dx
Add 8 New Agreements
Generate sustainable revenues sufficient to transition to a lower “cost of capital” business model and reduce exposure to capital markets
SQI Diagnostics- Investment Summary
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CONTACT INFORMATION:
SQI DIAGNOSTICS INC.
36 METEOR DRIVE
TORONTO, CANADA M9W 1A4
416-674-9500