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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