Upload
others
View
2
Download
0
Embed Size (px)
Citation preview
INVESTOR PRESENTATION 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 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
2
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 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
4
SQI’S CORE BUSINESS FOCUS
5
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
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
6
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
7
DNA Message
Proteins Function
PROTEINS TELL THE REAL STORY
DNA IS LESS CHALLENGING TO
WORK WITH
Antibodies Hormones Antigens Peptides Kinases
Cytokines Etc…
8
Proteins are big, sticky, and don’t play well together
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
COMPLEX PROTEIN ANALYSIS DEMANDS BETTER TOOLS
from qualitative tests… …to quantitative panels
11
Shift to multiplexed, automated tests significantly reduces time and labor
12
30 employees x 20 days 2 employees x 10 days
CLINICAL IMMUNOGENICITY
Test for Pharma/CROs
VALUE PROPOSITION
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
RECENT EXPANSION INTO MOLECULAR DETECTION
14
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
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
15
SQI Advantage
SQID ANALYZERS SIZED TO MEET DEMAND
16
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
COMPETITIVE OFFERINGS
17
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 STRATEGY
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
19
Target: 8+ active in 2015
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
20
FDA GUIDANCE = SQI PHARMA BUSINESS MODEL
21
Immunogenicity and ADA testing requirements
Epitope mapping or more complete characterization of
immunogenic responses
Drug Tolerance of ADA Assays
IG_PLEX™ BMS ANTI-DRUG ANTIBODY ASSAY
22
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
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
23
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
24
25
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
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
26
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
27
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
29
+ higher volume, “routine” panels cytokines, pk assays
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
30
APPENDIX
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
32
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
33
Core IVD Platform to Target High Volume Reference Labs
CONTACT INFORMATION:
SQI DIAGNOSTICS INC.
36 METEOR DRIVE
TORONTO, CANADA M9W 1A
416-674-9500