EMPOWERINGEMPOWERINGEMPOWERING EMPOWERING ONCOLOGY ONCOLOGY
DECISIONSDECISIONSDECISIONSDECISIONS
CORPORATECORPORATEPRESENTATIONSEPTEMBER 2011
SAFESAFE HARBOURHARBOUR STATEMENTSTATEMENT
TheThe statementsstatements mademade inin thisthis presentationpresentation oror inin responseresponse totoii hh hi i lhi i l ff f df d l kil kiquestionsquestions thatthat areare notnot historicalhistorical factsfacts areare forwardforward‐‐lookinglooking
statementsstatements thatthat involveinvolve risksrisks andand uncertainties,uncertainties, includingincluding butbut notnotlimitedlimited toto:: risksrisks associatedassociated withwith thethe uncertaintyuncertainty ofof productproductdevelopmentdevelopment andand commercializationcommercialization;; thethe impactimpact ofof competitivecompetitiveproductsproducts;; intellectualintellectual propertyproperty;; thethe riskrisk ofof unanticipatedunanticipated delaysdelaysinin researchresearch andand developmentdevelopment effortsefforts;; thethe risksrisks andand uncertaintiesuncertaintiesassociatedassociated withwith thethe regulationregulation ofof ourour teststests;; ourour abilityability toto obtainobtaincapitalcapital whenwhen neededneeded;; ourour historyhistory ofof operatingoperating losseslosses;; andand otherotherrisksrisks andand uncertainties,uncertainties, includingincluding thosethose detaileddetailed fromfrom timetime tototimetime inin periodicperiodic reports,reports, includingincluding thethe AnnualAnnual andand QuarterlyQuarterlyReportsReports filedfiled byby DiagnoCureDiagnoCure withwith thethe CanadianCanadian SecuritiesSecuritiesRegulatoryRegulatory AuthoritiesAuthorities..
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EMPOWERING ONCOLOGY DECISIONSEMPOWERING ONCOLOGY DECISIONS
Di C d l dDi C d l dDiagnoCure develops andDiagnoCure develops and
commercializes morecommercializes more
reliable cancer diagnosticreliable cancer diagnostic
tests to better support clinicians tests to better support clinicians
d ti t i ki d i i b td ti t i ki d i i b tand patients in making decisions about and patients in making decisions about
clinical interventions.clinical interventions.
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GLOBAL MARKET FORGLOBAL MARKET FORCANCER DIAGNOSTICSCANCER DIAGNOSTICSCANCER DIAGNOSTICSCANCER DIAGNOSTICS
$25.7 Bn Cancer diagnostics is projected to double in 5 years
16.20%
projected to double in 5 years propelled by converging trends.
CAGR
$12.2 Bn
• Growing elderly population
• Increased adoption of molecular testing
• Integration of quantitative assays in laboratory and clinical settings
• Growing number of joint ventures
2008 2013Note: this excludes
revenues from academic, Biopharma collaborationsLab services
and investments by major biopharma players
government and NGO grants
Source: The Sharma Group & TSG Partners
Lab servicesDx products
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TWO REVENUE GENERATING TWO REVENUE GENERATING PRODUCTSPRODUCTSPRODUCTSPRODUCTS
• Assay to help identify risk of having prostate cancercancer
• 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
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RECENTRECENT DEVELOPMENTDEVELOPMENT
& hSold US lab toSignal Genetics
US$5 7M
Licensed PrevistageGCC to Signal Genetics
Min US$5 1M first
R&D agreement withSignal Genetics to advance certain genomic testsUS$5.7M Min. US$5.1M first
5 yearsgenomic tests
US$2.5M
S h d fi i l i iStrengthened financial positionWith two cash annuity tests, DiagnoCure will continue to build on its
core expertise in developing clinically relevant and robust tests in cancer
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PIPELINE PIPELINE –– CLINICALLYCLINICALLY RELEVANT RELEVANT ONCOLOGYONCOLOGY TESTSTESTSONCOLOGYONCOLOGY TESTSTESTS
Prostate / Gen-ProbeUSA(ASR)
EU (CE)20 million
t t (W ld)PCA3* EU (CE)Canada
tests (World)
Colorectal /Previstage GCC*
Signal GeneticsCLIA lab
USA69,300 testsUSA & CAN
Lung /Diagnostic test
600,000 tests (USA & EU)
Other R&D
* DiagnoCure receives royalties on net sales realized by its partners.
ASR: Analyte Specific Reagent
g y y p
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PCA3 FOR PROSTATE CANCERPCA3 FOR PROSTATE CANCER((licensedlicensed toto GenGen‐‐Probe)Probe)((licensedlicensed to to GenGen Probe)Probe)
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PCA3PCA3((PPROSTATEROSTATE CACANCER GENE 3)NCER GENE 3)
PCA3 Assay:Direct detection of PCA3 in urine
((PPROSTATE ROSTATE CACANCER GENE 3)NCER GENE 3)
Prostate‐specific,non‐coding RNA1 Direct detection of PCA3 in urine
Tumor BPH Normal
non‐coding RNA
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.
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1Bussemakers, et al (1999) Canc Res 59:5975-5979
PCA3: SOLVING THE PROSTATEPCA3: SOLVING THE PROSTATECANCER DILEMMACANCER DILEMMACANCER DILEMMA CANCER DILEMMA
The Problem:The Problem:• Serum PSA: a standard test for
The Problem:The Problem:• Serum PSA: a standard test for
PCA3 test sold worldwideby Gen Probe• Serum PSA: a standard test for
screening Prostate Cancer is not specific!
PSA h f l iti t f 67%
• Serum PSA: a standard test for screening Prostate Cancer is not specific!
PSA h f l iti t f 67%
by Gen‐Probe
Detects prostate cancer not BPHDetects prostate cancer not BPH• PSA has a false positive rate of 67%
• Biopsy is costly and can be associated with considerable
i t di f t i d
• PSA has a false positive rate of 67%
• Biopsy is costly and can be associated with considerable
i t di f t i d
Reduces the number of unnecessary biopsies
Can assess the aggressiveness of
Reduces the number of unnecessary biopsies
Can assess the aggressiveness of anxiety, discomfort, pain and complications
• A large population of men with f l l l t d PSA h d
anxiety, discomfort, pain and complications
• A large population of men with f l l l t d PSA h d
ggthe cancer to guide treatment decision
Over 80 peerOver 80 peer‐‐reviewed reviewed
ggthe cancer to guide treatment decision
Over 80 peerOver 80 peer‐‐reviewed reviewed falsely elevated PSA has emerged over the yearsfalsely elevated PSA has emerged over the years
pppublicationspublications
pppublicationspublications
ProtectedProtected ntilntil 20272027 ndernder 11 U S patents (iss es or11 U S patents (iss es or filedfiled))
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ProtectedProtected untiluntil 2027 2027 underunder 11 U.S. patents (issues or 11 U.S. patents (issues or filedfiled))
PCA3 PCA3 PREDICTSPREDICTS RISKRISK OF POSITIVE OF POSITIVE BIOPSYBIOPSYAFTERAFTER A A PREVIOUSLYPREVIOUSLY NEGATIVENEGATIVE BIOPSYBIOPSY
□ 2,400 patients from2 arms of GSK’s
PCA3 and Prostate Biospy Results(N 1072 l b i REDUCE)2 arms of GSK’s
REDUCE trial on dutasteride
(N= 1072 placebo men in REDUCE)
3535
PCA3 can help decidedecideabout about repeatrepeat prostate prostate biopsiesbiopsies
CutCut--offoff
biopsiesbiopsies
PCA3 scores correlatewith Gleason Score, and
didicancan predictpredict cancer cancer severityseverity
Source: J. Groskopf, et al, Validation of the PCA3 molecular urine test for predicting repeat prostate biopsy outcome in the placebo arm of the dutasteride REDUCE trial, (ASCO GU), March 2010
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MULTIMULTI‐‐CENTER EUROPEAN STUDY: CENTER EUROPEAN STUDY: PCA3 BEFORE THE FIRST BIOPSYPCA3 BEFORE THE FIRST BIOPSYCOULD AVOID 40% OF BIOPSIESCOULD AVOID 40% OF BIOPSIESCOULD AVOID 40% OF BIOPSIESCOULD AVOID 40% OF BIOPSIES
40%
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Source: EAU et AUA 2011
THE PCA3 MARKET POTENTIALTHE PCA3 MARKET POTENTIAL
PSA testing45 million orld ide
ROYALTIES TO DIAGNOCURE:ROYALTIES TO DIAGNOCURE:currentlycurrently 8 %;45 million worldwide
High PSA Negative Physician may decide d bi
currently currently 8 %;16% beyond US$60M of cumulative sales
High PSA5 million
2 out of 3 biopsiesI i i l
NegativePCA3 test not to do biopsy
2 out of 3 biopsies end up NEGATIVE1
1.8 million Do I need Do I need aabiopsy?biopsy?
Initial indication Reduce number of Reduce number of
biopsies by 60%biopsies by 60%
Expanded market opportunity
20 million @ $100$2 billion
Worldwide market opportunity
1.8 million @ $100$180 million
131) PSA specificity: less than 30%PCA3 specificity: 70-75%
$2 billion(initial claim only)
POTENTIAL ROYALTIES BASED ON POTENTIAL ROYALTIES BASED ON MARKET PENETRATION LEVELMARKET PENETRATION LEVELMARKET PENETRATION LEVELMARKET PENETRATION LEVEL
PCA3 after 1st biopsy
$10
$12
$14
$6
$8
$10
Millions $
$0
$2
$4
Assumptions: PCA3: 16% on sales from Gen Probe US and EU markets
$0
5% 10% 25% 50%
PCA3: 16% on sales from Gen‐Probe, US and EU marketsNb of tests: 1.8M if only after 1st biopsy / 20M if used before 1st biopsy
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POTENTIAL ROYALTIES BASED ON POTENTIAL ROYALTIES BASED ON MARKET PENETRATION LEVELMARKET PENETRATION LEVELMARKET PENETRATION LEVELMARKET PENETRATION LEVEL
$160
PCA3 after 1st biopsy +PCA3 before 1st biopsy
$120
$140
$160
$60
$80
$100
Millions $
$0
$20
$40
$0
5% 10% 25% 50%
Assumptions: PCA3: 16% on sales from Gen Probe US and EU markets
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PCA3: 16% on sales from Gen‐Probe, US and EU marketsNb of tests: 1.8M if only after 1st biopsy / 20M if used before 1st biopsy
COMMERCIALIZATIONCOMMERCIALIZATIONOF PCA3OF PCA3OF PCA3OF PCA3
□□ SuccessfulSuccessful commercial effortscommercial effortsUSA: 13 labpratoires offer the ASR version
– Submitted for approval for the FDA
Europe over 40 laboratoires and collection sites offer theEurope over 40 laboratoires and collection sites offer the PROGENSA PCA3 test (CE marked)
Approuved by Health Canada (2011)
□□ SecondSecond‐‐generationgenerationfully automated assay onfully automated assay onPANTHER around 2013PANTHER around 2013PANTHER around 2013PANTHER around 2013
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(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.
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COLORECTAL CANCER STAGINGCOLORECTAL CANCER STAGING
165,000 CRC cases each year in North America
• Lymph node NEGATIVEh h ??
Stage I d II • Chemotherapy??and II
• Lymph node POSITIVE• Lymph node POSITIVE• Chemotherapy
Stage III
• Metastatic disease• Chemotherapy
Stage IV
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HISTOPATHOLOGY VS.HISTOPATHOLOGY VS.PREVISTAGEPREVISTAGETMTM GCCGCCPREVISTAGEPREVISTAGE GCCGCC
Accurate staging is the single most important prognostic factor to predict disease recurrence and survival.1,2
Histopathology
1 cancer cell in 200 normal cellsSensitivity
Previstage™ GCC
1 cancer cell in 10 million normal ll (100 000 i t)
<1% of lymph node tissueSample Size
cells (100,000x improvement)
>50% of the submitted lymph node tissue (375x improvement)
Manual, subjective measurement of lymph node metastases
Process Automated measurement using ultra‐sensitive RT‐qPCR
metastases
Analytical sensitivity of 92% and specificity of 98%
ProtectedProtected by 11 U S patents/applicationsby 11 U S patents/applications until 2until 2030
1. Joseph, NE et al., Ann Surg Oncol. 2003; 10(3):213‐82. Iddings, D et al, Ann Surg Oncol. 2006;13(11):1386‐92.
Protected Protected by 11 U.S. patents/applications by 11 U.S. patents/applications until 2until 2030
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VITAR STUDY RESULTS:VITAR STUDY RESULTS:PREDICTION OF RISK OF RECURRENCE IN PREDICTION OF RISK OF RECURRENCE IN PATIENTS WITH STAGE II COLON CANCERPATIENTS WITH STAGE II COLON CANCERPATIENTS WITH STAGE II COLON CANCERPATIENTS WITH STAGE II COLON CANCER
SELECTED SUBSET OF 181 PATIENTSWITH T3 TUMOR ≥ 12 LYMPH NODES
26.9%
60%
WITH T3 TUMOR, ≥ 12 LYMPH NODES
er
PrevistageTM GCC can stratify the risk of
recurrence in stage II
30%
45%C
olon
Can
ceen
ce a
t 5yr
scolon cancer patients:
High risk patients4.0%
15%
Ris
k of
CR
ecur
reHigh risk patients have 6 times greater
likelihood of recurrence than low
0%High Risk
(GCC LNR >0.1)n = 64
Low Risk (GCC LNR ≤0.1)
n= 117
recurrence than low risk patients
Sargent D J et al Evaluation of Guanylyl Cyclase C Lymph Node Status forSargent, D J, et al., Evaluation of Guanylyl Cyclase C Lymph Node Status for Colon Cancer Staging and Prognosis, Ann Surg Oncol., 2011 May 1
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PREVISTAGEPREVISTAGE™ GCC™ GCCMARKET POTENTIALMARKET POTENTIALMARKET POTENTIALMARKET POTENTIAL
TreatmentPathology Treatment
Diagnosis165,000 in North
A i *
Stage IVMetastatic
34,700Stage III61,000
CANCER SPREAD TO LYMPH NODES
Adjuvantchemotherapy
PathologyPathology Treatment
GCC NEGATIVE—No evidence of metastases
America*Surgeries130,300
Stage I & II
69 300
Europe1: 280,000Japan: 94,500
GCC POSITIVE—Evidence of metastases equal to Stage III pN1,
pN2
69,300CANCER “CONFINED”
Has my cancer spread?
ROYALTIES TOROYALTIES TOPatient may be
considered Stage III by physician
NA market opportunity:NA market opportunity:69,300 @ $3,00069,300 @ $3,000
$200 million$200 million
ROYALTIES TO ROYALTIES TO DIAGNOCURE:DIAGNOCURE:
High single digit %High single digit %
21* Sources: Various cancer societies 1. European Economic Union
POTENTIALPOTENTIAL ROYALTIES ROYALTIES BASEDBASED ON ON MARKETMARKET PENETRATIONPENETRATION LEVELLEVELMARKETMARKET PENETRATIONPENETRATION LEVELLEVEL
$8
Previstage GCC
$6
$8
$4
Millions $
$0
$2
Assumptions: GCC: High single digit percentage from Signal Genetics
$0
5% 10% 25% 50%
GCC: High single digit percentage from Signal GeneticsNb of tests: 69,900 (North America only)
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Lung CancerLung CancerDiagnostic TestDiagnostic TestDiagnostic TestDiagnostic Test
(in development)
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LUNG CANCER PROGRAMLUNG CANCER PROGRAM
□□ DiagnoCure DiagnoCure isis resumingresuming itsits lunglung cancer programcancer programLeverage it past investments in Lung Cancer R&D
Leverage its core expertise in molecular test development
Develop Multiplex PCR diagnostic test forDevelop Multiplex PCR diagnostic test forLung Cancer on bronchial aspirates
Market potential: $600M +
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LUNG CANCER DIAGNOSTIC TESTLUNG CANCER DIAGNOSTIC TEST
□□ IncreasingIncreasing numbernumber of cases of of cases of lunglung cancercancer221 100 new cases and 157 000 deaths each year in the U S221,100 new cases and 157,000 deaths each year in the U.S. (2011)1.6 million new cases and 1.3 million deaths each year worldwideFirst cause of cancer death
□□ UnmetUnmet clinicalclinical needneedDiagnosis: 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)
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by the initial tests (low sensitivity)
LUNG CANCER DIAGNOSTIC TESTLUNG CANCER DIAGNOSTIC TESTMARKET POTENTIALMARKET POTENTIALMARKET POTENTIALMARKET POTENTIAL
Initial Investigation
BronchoscopyChest X‐Ray
50% of bronchoscopy result1are a positive diagnosis
diagnosisand/or CT Scan50% of bronchoscopy result are negative or inconclusive
Do I haveDo I haveLung Cancer?Lung Cancer? ll ?ll ?Lung Cancer?Lung Cancer? Is it really negative?Is it really negative?
What is it exactly?What is it exactly?
Expanded market opportunity (US & Europe)
600,000 @ $1000$600 million
Limited marketopportunity (US & Europe)
300,000 @ $1000$300 million
261Roth et al, BMC Pulmonary Medicine, 2008, 8:2
FINANCIAL HIGHLIGHTSFINANCIAL HIGHLIGHTS
Common Shares O/S (J l 31 2011) 42 9 millionCommon Shares O/S (July 31, 2011)Preferred Shares O/S (July 31, 2011)
42.9 million4.9 million
M k C (A 24 2011) $42 6 illiMarket Cap (August 24, 2011) $42.6 million
Cash on hand (July 31 2011) $8 8 millionCash on hand (July 31, 2011) $8.8 million
Employees (July 31, 2011) 15 (R&D: 8)
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MANAGEMENT TEAMMANAGEMENT TEAM
Independent Board Members
• Alain G. MichelChairman of the Board, Cari‐All Group
• Louise Proulx Ph D
• Mario Thomas, Ph.D.Senior Vice‐PresidentOntario Centres of Excellence
• Vincent R Zurawski Jr Ph D
• Michel E. CôtéCorporate Director
• Paul Gobeil FCA • Louise Proulx, Ph.D.Vice President, Research and Development,Vertex Pharmaceuticals (Canada)
• Vincent R. Zurawski, Jr., Ph.D.Chairman of the Board and Chief Executive Officer, AvrahamPharmaceuticals Ltd.
• Paul Gobeil, FCAL:ead Director, DiagnoCure, Inc.Vice Chairman of the Board,Metro Inc.
Management Team
• Chantal Miklosi, MBAChief Financial Officero JMP Securities
• Paule De Blois, MBASenior Vice President, Operations
• Yves Fradet, M.D., FRCS(c)Chairman of the BoardPresident and o JMP Securities
o Orrick, Herrington &Sutcliffe LLP
o Versata
Operationso Mercer Consultingo Aon Consultingo Desjardins Financial
Securities
President and Chief Medical Officero Founder of DiagnoCureo CHUQ‐ Hôtel Dieu de
Québec
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INVESTMENT IN DIAGNOCUREINVESTMENT IN DIAGNOCURE
□□ FocusedFocused strategystrategy on on genomicgenomic tests fortests forli dli d di idi ipersonalizedpersonalized medicinemedicine
Market expected to double to $7B over the next few years
□□ ProprietaryProprietary tests and pipelinetests and pipeline□□ ProprietaryProprietary tests and pipelinetests and pipeline□□ 2 revenue2 revenue‐‐generatinggenerating teststests□□ ProvenProven tracktrack recordrecord
High complexity molecular assay developmentRegulatory strategies (FDA, CE mark, CLIA)Clinical studiesClinical studiesAcademic and commercial partnerships
□□ SufficientSufficient cash to cash to reachreach profitabilityprofitability
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