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INVESTOR PRESENTATION 2015

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Page 1: INVESTOR PRESENTATION 2015 · 2020-01-06 · SOURCES OF PHARMA CUSTOMER REVENUE Development Services $50,000 -$400,000 Platform purchases $60,000 & $120,000 Validation test kit purchases

INVESTOR PRESENTATION 2015

Page 2: INVESTOR PRESENTATION 2015 · 2020-01-06 · SOURCES OF PHARMA CUSTOMER REVENUE Development Services $50,000 -$400,000 Platform purchases $60,000 & $120,000 Validation test kit purchases

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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Page 3: INVESTOR PRESENTATION 2015 · 2020-01-06 · SOURCES OF PHARMA CUSTOMER REVENUE Development Services $50,000 -$400,000 Platform purchases $60,000 & $120,000 Validation test kit purchases

SQI DIAGNOSTICS

3

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

Page 4: INVESTOR PRESENTATION 2015 · 2020-01-06 · SOURCES OF PHARMA CUSTOMER REVENUE Development Services $50,000 -$400,000 Platform purchases $60,000 & $120,000 Validation test kit purchases

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

4

Page 5: INVESTOR PRESENTATION 2015 · 2020-01-06 · SOURCES OF PHARMA CUSTOMER REVENUE Development Services $50,000 -$400,000 Platform purchases $60,000 & $120,000 Validation test kit purchases

5

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

Page 6: INVESTOR PRESENTATION 2015 · 2020-01-06 · SOURCES OF PHARMA CUSTOMER REVENUE Development Services $50,000 -$400,000 Platform purchases $60,000 & $120,000 Validation test kit purchases

CORE BUSINESS FOCUS

6

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

Page 7: INVESTOR PRESENTATION 2015 · 2020-01-06 · SOURCES OF PHARMA CUSTOMER REVENUE Development Services $50,000 -$400,000 Platform purchases $60,000 & $120,000 Validation test kit purchases

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

Page 8: INVESTOR PRESENTATION 2015 · 2020-01-06 · SOURCES OF PHARMA CUSTOMER REVENUE Development Services $50,000 -$400,000 Platform purchases $60,000 & $120,000 Validation test kit purchases

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

8

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

target revenue per platform is $1 to $2M

Page 9: INVESTOR PRESENTATION 2015 · 2020-01-06 · SOURCES OF PHARMA CUSTOMER REVENUE Development Services $50,000 -$400,000 Platform purchases $60,000 & $120,000 Validation test kit purchases

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

9

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

Page 10: INVESTOR PRESENTATION 2015 · 2020-01-06 · SOURCES OF PHARMA CUSTOMER REVENUE Development Services $50,000 -$400,000 Platform purchases $60,000 & $120,000 Validation test kit purchases

UNIQUE DUAL-LAYER PROTEIN MULTIPLEXING

IG_PLEX™

10

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

Page 11: INVESTOR PRESENTATION 2015 · 2020-01-06 · SOURCES OF PHARMA CUSTOMER REVENUE Development Services $50,000 -$400,000 Platform purchases $60,000 & $120,000 Validation test kit purchases

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 $$$$ $$$ $

Page 12: INVESTOR PRESENTATION 2015 · 2020-01-06 · SOURCES OF PHARMA CUSTOMER REVENUE Development Services $50,000 -$400,000 Platform purchases $60,000 & $120,000 Validation test kit purchases

COMMERCIALIZATION

Page 13: INVESTOR PRESENTATION 2015 · 2020-01-06 · SOURCES OF PHARMA CUSTOMER REVENUE Development Services $50,000 -$400,000 Platform purchases $60,000 & $120,000 Validation test kit purchases

CASE STUDY

SIGNIFICANT LABOUR AND TIME SAVINGS

13

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

Page 14: INVESTOR PRESENTATION 2015 · 2020-01-06 · SOURCES OF PHARMA CUSTOMER REVENUE Development Services $50,000 -$400,000 Platform purchases $60,000 & $120,000 Validation test kit purchases

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

1 of 33

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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Page 15: INVESTOR PRESENTATION 2015 · 2020-01-06 · SOURCES OF PHARMA CUSTOMER REVENUE Development Services $50,000 -$400,000 Platform purchases $60,000 & $120,000 Validation test kit purchases

Commercialization Scorecard

15

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)

Page 16: INVESTOR PRESENTATION 2015 · 2020-01-06 · SOURCES OF PHARMA CUSTOMER REVENUE Development Services $50,000 -$400,000 Platform purchases $60,000 & $120,000 Validation test kit purchases

“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

Page 17: INVESTOR PRESENTATION 2015 · 2020-01-06 · SOURCES OF PHARMA CUSTOMER REVENUE Development Services $50,000 -$400,000 Platform purchases $60,000 & $120,000 Validation test kit purchases

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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Page 18: INVESTOR PRESENTATION 2015 · 2020-01-06 · SOURCES OF PHARMA CUSTOMER REVENUE Development Services $50,000 -$400,000 Platform purchases $60,000 & $120,000 Validation test kit purchases

MANAGEMENT TEAM

Page 19: INVESTOR PRESENTATION 2015 · 2020-01-06 · SOURCES OF PHARMA CUSTOMER REVENUE Development Services $50,000 -$400,000 Platform purchases $60,000 & $120,000 Validation test kit purchases

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

Page 20: INVESTOR PRESENTATION 2015 · 2020-01-06 · SOURCES OF PHARMA CUSTOMER REVENUE Development Services $50,000 -$400,000 Platform purchases $60,000 & $120,000 Validation test kit purchases

BOARD OF DIRECTORS

20

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

Page 21: INVESTOR PRESENTATION 2015 · 2020-01-06 · SOURCES OF PHARMA CUSTOMER REVENUE Development Services $50,000 -$400,000 Platform purchases $60,000 & $120,000 Validation test kit purchases

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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Page 22: INVESTOR PRESENTATION 2015 · 2020-01-06 · SOURCES OF PHARMA CUSTOMER REVENUE Development Services $50,000 -$400,000 Platform purchases $60,000 & $120,000 Validation test kit purchases

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

22

Page 23: INVESTOR PRESENTATION 2015 · 2020-01-06 · SOURCES OF PHARMA CUSTOMER REVENUE Development Services $50,000 -$400,000 Platform purchases $60,000 & $120,000 Validation test kit purchases

CONTACT INFORMATION:

SQI DIAGNOSTICS INC.

36 METEOR DRIVE

TORONTO, CANADA M9W 1A4

[email protected]

416-674-9500