2. SAFE HARBOUR STATEMENT
The statements made in this presentation or in response to
questions that are not historical facts are forward‐looking
i h hi i l f forward‐l ki
f d
statements that involve risks and uncertainties, including but not
limited to: risks associated with the uncertainty of product
to:
development and commercialization; the impact of competitive
commercialization;
products;
products; intellectual property; the risk of unanticipated delays
property;
in research and development efforts; the risks and uncertainties
efforts;
associated with the regulation of our tests; our ability to obtain
tests;
capital when needed; our history of operating losses; and other
needed; losses;
risks and uncertainties, including those detailed from time to
time in periodic reports, including the Annual and Quarterly
Reports filed by DiagnoCure with the Canadian Securities
Regulatory Authorities.
Authorities.
2
3. EMPOWERING ONCOLOGY DECISIONS
DiagnoCure develops and
Di C d l d
commercializes more
reliable cancer diagnostic
tests to better support clinicians
and patients in making decisions about
d ti t i ki d i i b t
clinical interventions.
3
4. GLOBAL MARKET FOR
CANCER DIAGNOSTICS
CANCER DIAGNOSTICS
$25.7 Bn
Cancer diagnostics is
projected to double in 5 years
projected to double in 5 years
propelled by converging
trends.
16.20%
CAGR • Growing elderly population
$12.2 Bn • Increased adoption of molecular
testing
• Integration of quantitative assays
in laboratory and clinical settings
• Growing number of joint ventures
and investments by major
2008 2013 biopharma players
Note: this excludes Biopharma collaborations
revenues from academic, Lab services
government and NGO
grants Dx products
Source: The Sharma Group & TSG Partners 4
5. TWO REVENUE GENERATING
PRODUCTS
• Assay to help identify risk of having prostate
cancer
• Licensed to Gen‐Probe in 2003
• Launched in Europe and partly in the US
• Increasing royalty payments
• Approved in Europe and Canada
• Submitted to the FDA in September 2010
• Potential of 20 million tests worldwide
• Colorectal cancer staging test to better assess
the risk of recurrence
• Launched in 2008
• Licensed to Signal Genetics in June 2011
• Reached 3% of U.S. North East market
• Potential of 69,300 tests in North America
5
6. RECENT DEVELOPMENT
R&D agreement with
& h
Licensed Previstage
Sold US lab to Signal Genetics to
GCC to Signal Genetics
Signal Genetics advance certain
Min. US$5.1M first
Min US$5 1M first genomic tests
US$5.7M
US$5 7M 5 years
US$2.5M
Strengthened fi
S h d financial position
i l ii
With two cash annuity tests, DiagnoCure will continue to build on its
core expertise in developing clinically relevant and robust tests in cancer
6
7. PIPELINE –
PIPELINE – CLINICALLY RELEVANT
ONCOLOGY TESTS
Gen-Probe
Prostate / USA(ASR) 20 million
EU (CE)
PCA3* Canada
tests (W ld)
t t (World)
Colorectal / Signal Genetics
CLIA lab
69,300 tests
Previstage GCC* USA USA & CAN
Lung / 600,000 tests
Diagnostic test (USA & EU)
Other R&D
* DiagnoCure receives royalties on net sales realized by its partners.
g y y p
ASR: Analyte Specific Reagent 7
9. PCA3
(PROSTATE CANCER GENE 3)
ROSTATE CANCER
ROSTATE CANCER GENE 3)
CANCER GENE 3)
Prostate‐specific, PCA3 Assay:
non‐coding RNA1
non‐coding RNA Direct detection of PCA3 in urine
Tumor BPH Normal
PCA3
PSA
Studies have shown that PCA3 RNA is overexpressed,
relative to benign cells, by 60 to 100‐fold in more than
90% of prostate tumors.
1Bussemakers, et al (1999) Canc Res 59:5975-5979
9
10. PCA3: SOLVING THE PROSTATE
CANCER DILEMMA
CANCER DILEMMA
The Problem: PCA3 test sold worldwide
• Serum PSA: a standard test for
Serum PSA: a standard test for by Gen‐Probe
by Gen Probe
screening Prostate Cancer is not
specific! Detects prostate cancer not BPH
• PSA has a false positive rate of 67%
PSA h f l iti t f 67%
Reduces the number of
• Biopsy is costly and can be unnecessary biopsies
associated with considerable
gg
Can assess the aggressiveness of
anxiety, discomfort, pain and
i t di f t i d
the cancer to guide treatment
complications decision
• A large population of men with
Over 80 peer‐reviewed
Over 80 peer‐
p
f l l l t d PSA h d
falsely elevated PSA has emerged publications
over the years
Protected until 2027 under 11 U S patents (iss es or filed)
ntil 2027 nder 11 U.S. patents (issues or filed)
2027 under 11 U.S. patents (issues or filed
10
11. PCA3 PREDICTS
PCA3 PREDICTS RISK OF POSITIVE BIOPSY
OF POSITIVE BIOPSY
AFTER A PREVIOUSLY NEGATIVE BIOPSY
A PREVIOUSLY
□ 2,400 patients from PCA3 and Prostate Biospy Results
2 arms of GSK’s
2 arms of GSK’s (N= 1072 placebo men in REDUCE)
(N 1072 l b i REDUCE)
REDUCE trial on
dutasteride 35
Cut-
Cut-off
PCA3 can help decide
decide
about repeat
about repeat prostate
biopsies
PCA3 scores correlate
with Gleason Score, and
can predict cancer
di
Source: J. Groskopf, et al, Validation of the PCA3 molecular urine test for
severity predicting repeat prostate biopsy outcome in the placebo arm of the
dutasteride REDUCE trial, (ASCO GU), March 2010
11
12. MULTI‐
MULTI‐CENTER EUROPEAN STUDY:
PCA3 BEFORE THE FIRST BIOPSY
COULD AVOID 40% OF BIOPSIES
COULD AVOID 40% OF BIOPSIES
40%
Source: EAU et AUA 2011
12
13. THE PCA3 MARKET POTENTIAL
ROYALTIES TO DIAGNOCURE:
PSA testing
45 million worldwide
orld ide currently 8 %;
currently
currently 8 %;
16% beyond US$60M of cumulative sales
High PSA Physician may decide
Negative
not to do biopsy
d bi
5 million PCA3 test
Initial
I ii l 2 out of 3 biopsies
indication end up NEGATIVE1
Reduce number of
1.8 million Do I need a
Do I need a biopsies by 60%
biopsy?
Worldwide market Expanded market
opportunity opportunity
1.8 million @ $100 20 million @ $100
$180 million $2 billion
$2 billion
(initial claim only)
1) PSA specificity: less than 30% 13
PCA3 specificity: 70-75%
14. POTENTIAL ROYALTIES BASED ON
MARKET PENETRATION LEVEL
MARKET PENETRATION LEVEL
PCA3 after 1st biopsy
$14
$12
$10
Millions $
$8
$6
$4
$2
$0
5% 10% 25% 50%
Assumptions:
PCA3: 16% on sales from Gen‐Probe, US and EU markets
PCA3: 16% on sales from Gen Probe US and EU markets
Nb of tests: 1.8M if only after 1st biopsy / 20M if used before 1st biopsy
14
15. POTENTIAL ROYALTIES BASED ON
MARKET PENETRATION LEVEL
MARKET PENETRATION LEVEL
PCA3 after 1st biopsy +PCA3 before 1st biopsy
$160
$140
$120
Millions $
$100
$80
$60
$40
$20
$0
5% 10% 25% 50%
Assumptions:
PCA3: 16% on sales from Gen‐Probe, US and EU markets
PCA3: 16% on sales from Gen Probe US and EU markets
Nb of tests: 1.8M if only after 1st biopsy / 20M if used before 1st biopsy
15
16. COMMERCIALIZATION
OF PCA3
OF PCA3
□ Successful commercial efforts
USA: 13 labpratoires offer the ASR version
– Submitted for approval for the FDA
Europe over 40 laboratoires and collection sites offer the
Europe over 40 laboratoires and collection sites offer the
PROGENSA PCA3 test (CE marked)
Approuved by Health Canada (2011)
□ Second‐generation
Second‐
fully automated assay on
PANTHER around 2013
PANTHER around 2013
16
17. (Licensed to Signal Genetics)
The PrevistageTM GCC Colorectal Cancer Staging Test is a laboratory-developed test. It is now offered by
Signal Genetics, a laboratory certified under CLIA regulation as high-complexity laboratory.
17
18. COLORECTAL CANCER STAGING
165,000 CRC cases each year in North America
Stage I • Lymph node NEGATIVE
and II
d II • Chemotherapy??
h h ??
• Lymph node POSITIVE
Stage III • Chemotherapy
• Metastatic disease
Stage IV • Chemotherapy
18
19. HISTOPATHOLOGY VS.
PREVISTAGETM GCC
Accurate staging is the single most important prognostic factor to
predict disease recurrence and survival.1,2
Histopathology Previstage™ GCC
Sensitivity 1 cancer cell in 200 normal cells 1 cancer cell in 10 million normal
cells (100,000x improvement)
ll (100 000 i t)
Sample Size <1% of lymph node tissue >50% of the submitted lymph
node tissue (375x improvement)
Process Manual, subjective Automated measurement using
measurement of lymph node ultra‐sensitive RT‐qPCR
metastases
Analytical sensitivity of 92% and specificity of 98%
Protected by 11 U.S. patents/applications until 2030
Protected by 11 U.S. patents/applications until 2
Protected by 11 U S patents/applications until 22030
1. Joseph, NE et al., Ann Surg Oncol. 2003; 10(3):213‐8 19
2. Iddings, D et al, Ann Surg Oncol. 2006;13(11):1386‐92.
20. VITAR STUDY RESULTS:
PREDICTION OF RISK OF RECURRENCE IN
PATIENTS WITH STAGE II COLON CANCER
PATIENTS WITH STAGE II COLON CANCER
SELECTED SUBSET OF 181 PATIENTS
WITH T3 TUMOR ≥ 12 LYMPH NODES
TUMOR,
PrevistageTM GCC can
stratify the risk of 60%
recurrence in stage II 26.9%
Risk of Colon Canceer
colon cancer
ence at 5yrs
45%
patients:
30%
High risk patients
High risk patients
Recurre
C
have 6 times greater 4.0%
15%
likelihood of
recurrence than low
recurrence than low 0%
risk patients Low Risk High Risk
(GCC LNR ≤0.1) (GCC LNR >0.1)
n= 117 n = 64
Sargent, D J, et al., Evaluation of Guanylyl
Sargent D J et al Evaluation of Guanylyl Cyclase C Lymph Node Status for
C Lymph for
Colon Cancer Staging and Prognosis, Ann Surg Oncol., 2011 May 1
20
21. PREVISTAGE™ GCC
PREVISTAGE™ GCC
MARKET POTENTIAL
MARKET POTENTIAL
Treatment
Pathology Treatment
Stage IV
Pathology Metastatic Stage III
34,700 61,000 Adjuvant
Diagnosis CANCER SPREAD TO chemotherapy
165,000 in North LYMPH NODES
America*
A i *
Surgeries
Europe1: 280,000 130,300 GCC NEGATIVE—No
Japan: 94,500 evidence of metastases
Stage I & II
Has my cancer 69 300
69,300 GCC POSITIVE—
spread? CANCER “CONFINED” Evidence of metastases
equal to Stage III pN1,
pN2
ROYALTIES TO
ROYALTIES TO
DIAGNOCURE: NA market opportunity: Patient may be
69,300 @ $3,000 considered Stage III
High single digit % $200 million by physician
* Sources: Various cancer societies 21
1. European Economic Union
22. POTENTIAL ROYALTIES BASED ON
ROYALTIES BASED
MARKET PENETRATION LEVEL
Previstage GCC
$8
$6
Millions $
$4
$2
$0
5% 10% 25% 50%
Assumptions:
GCC: High single digit percentage
GCC: High single digit percentage from Signal Genetics
Signal Genetics
Nb of tests: 69,900 (North America only)
22
24. LUNG CANCER PROGRAM
□ DiagnoCure is resuming its lung cancer program
DiagnoCure is
Leverage it past investments in Lung Cancer R&D
Leverage its core expertise in molecular test development
Develop Multiplex PCR diagnostic test for
Multiplex PCR diagnostic test for
Lung Cancer on bronchial aspirates
Market potential: $600M +
24
25. LUNG CANCER DIAGNOSTIC TEST
□ Increasing number of cases of lung cancer
of cases of lung
221,100 new cases and 157,000 deaths each year in the U.S.
221 100 new cases and 157 000 deaths in the U S
(2011)
1.6 million new cases and 1.3 million deaths each year worldwide
First cause of cancer death
□ Unmet clinical need
Diagnosis: bronchoscopy followed by a histology or cytology test
Results: 50% negative or inconclusive
50% of these have lung cancer but it is not detected
by the initial tests (low sensitivity)
by the initial tests (low sensitivity)
25
26. LUNG CANCER DIAGNOSTIC TEST
MARKET POTENTIAL
MARKET POTENTIAL
Initial Investigation
50% of bronchoscopy result1
are a positive diagnosis
Chest X‐Ray Bronchoscopy
and/or CT Scan diagnosis
50% of bronchoscopy result
are negative or inconclusive
Do I have
Lung Cancer?
Lung Cancer?
Is it really negative?
ll ?
What is it exactly?
Expanded market Limited market
opportunity (US & Europe) opportunity (US & Europe)
600,000 @ $1000 300,000 @ $1000
$600 million $300 million
1Roth et al, BMC Pulmonary Medicine, 2008, 8:2 26
27. FINANCIAL HIGHLIGHTS
Common Shares O/S (July 31,
Common Shares O/S (J l 31 2011) 42.9 million
42 9 million
Preferred Shares O/S (July 31, 2011) 4.9 million
Market Cap (August 24, 2011)
M k C (A 24 2011) $42.6 illi
$42 6 million
Cash on hand (July 31 2011)
on hand (July 31, 2011) $8.8 million
$8 8 million
Employees (July 31, 2011) 15 (R&D: 8)
27
28. MANAGEMENT TEAM
Independent Board Members
• Michel E. Côté • Alain G. Michel • Mario Thomas, Ph.D.
Corporate Director Chairman of the Board, Senior Vice‐President
Cari‐All Group Ontario Centres of Excellence
• Paul Gobeil FCA
Paul Gobeil, FCA • Louise Proulx Ph D
Louise Proulx, Ph.D. • Vincent R Zurawski Jr Ph D
Vincent R. Zurawski, Jr., Ph.D.
L:ead Director, DiagnoCure, Inc. Vice President, Research and Chairman of the Board and Chief
Vice Chairman of the Board, Development, Executive Officer, Avraham
Metro Inc. Vertex Pharmaceuticals (Canada) Pharmaceuticals Ltd.
Management Team
• Yves Fradet, M.D., FRCS(c) • Chantal Miklosi, MBA • Paule De Blois, MBA
Chairman of the Board Chief Financial Officer Senior Vice President,
President and
President and o JMP Securities
JMP Securities Operations
Chief Medical Officer o Orrick, Herrington & o Mercer Consulting
o Founder of DiagnoCure Sutcliffe LLP o Aon Consulting
o CHUQ‐ Hôtel Dieu de o Versata o Desjardins Financial
Québec Securities
28
29. INVESTMENT IN DIAGNOCURE
□ Focused strategy on genomic tests for
on genomic
personalized medicine
li d di i
Market expected to double to $7B over the next few years
□ Proprietary tests and pipeline
tests and pipeline
□ 2 revenue‐generating tests
2 revenue‐
□ Proven track record
High complexity molecular assay development
Regulatory strategies (FDA, CE mark, CLIA)
Clinical studies
Academic and commercial partnerships
□ Sufficient cash to reach profitability
cash to reach
29
