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Arraygenomics bp may 2012

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Presentation of Arraygenomics and the products developped for cancer research and medical treatment
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ArrayGenomics ArrayGenomics 1 Corporate Presentation May 2011 ArrayGenomics, an innovative molecular diagnostics company with new, high performance, cancer specific assays on multiple advanced diagnostic platforms
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Page 1: Arraygenomics bp may 2012

ArrayGenomics

ArrayGenomics 1

Corporate Presentation

May 2011

ArrayGenomics, an innovativemolecular diagnostics companywith new, high performance, cancerspecific assays on multiple advanced diagnostic platforms

Page 2: Arraygenomics bp may 2012

ArrayGenomics

ArrayGenomics 2

Array Genomics S.A. was founded in 2003 and is based in the Parisian technology hub of Voisins le Bretonneux . Since inception Array Genomics has leveraged strategic partnerships and internal Research and Development to provide and distribute array-based technologies to the academic research sector as well as the clinical diagnostics arena. The company is privately held by founders/friends but is now seeking to raise external equity financing of Euros >20M to grow the company.

Objectives

• To outline our patented, clinician-designed, disease specific “Back-Up” range of arrays for bladder cancer with kidney, prostate cancers with other cancer tests in the development pipeline( lung)

• Focus on our first test - bladder cancer diagnosis and monitoring assay (BCA oligo) with an initial RUO version launched Q2 2012, with concomitant clinical impact and financial opportunities. Following planned clinical trials FDA and IVD approval will allow the company to access a >$3billion dollar market

• The company is committed to launching their range of specific cancer arrays and plan an IPO over the next 12-18 months

Objectives of Meeting and Presentation

Page 3: Arraygenomics bp may 2012

ArrayGenomics

ArrayGenomics 3

Technology

DNA Extraction

HybridationOn a DNA array

Scanner Optical analysisOf the signal

Red Spot=Fit

RNA/DNACancerCells

Normal Cells

Fluorescent labelred

FluorescentLabelgreen

ADNc

ADNc

Labelling ofsamples

Samplesmixed

Green Spot =

No ARN/ADN

Sources : BioStrategic Options, Millicell, Arrayit, Combimatrix

DNA array

Our business model allows us to transpose our unique design based on the company’s patented zones of interest in Bladder, Kidney, Prostate and Lung cancer onto various technologies, initially using an oligonucleotide Comparative Genomic Hybridisation (CGH) array from Agilent

The technology is easily automated, highly sensitive, non-invasive and answers the urologist/oncologist demands not presently met by traditional or existing commercial biomarker products available for use in clinical laboratories around the world

Page 4: Arraygenomics bp may 2012

ArrayGenomics

ArrayGenomics 4

Business Model

Agilent /Affysupplier/logistics/

distribution partner

Clinical labs

ArrayGenomics:R & D

Clinical trialsSales key customers

• Using its patented technology, ArrayGenomics has initially embedded its design onto an Agilent oligonucleotide array exclusively manufactured for the Company by Agilent

• Agilent has agreed to manufacture , deliver and support the ArrayGenomics array worldwide

• Array Genomics will sell its proprietary in-house designed array through genomic providers and large institutes and hospitals using the RUO test to be followed once clinical trials have been run as a FDA approved diagnostic product

NB :- ArrayGenomics is presently negotiating to extend its array offering and its patented design to other diagnostic platforms.

Page 5: Arraygenomics bp may 2012

ArrayGenomics

ArrayGenomics 5

Product pipeline / Market opportunity

Target Indications

Biomarker Identification

Prroof of Clinical concept

ValidationRUO/CLIA

USA

Prototypeof test

.Clin. Dev.&

Regulatory.USA

CEMark

FDA 510k

Bladder Cancer Monitoring

Kidney Cancer

Prostate Cancer

Screening Lung Cancer

Screening

Screening

Incidence(New cases

per year)

Total market (est.)

Bladder monitoring $1,5 BillionBladder Screening $2,0 BillionProstate $2,0 BillionKidney $0,5 BllionLung $3,5 Billion

Total $10 Billion

Marketpotential

(Nb of tests p.a.)

ScreeningHematuria

383,000 (World)74,000 (USA/Can.)119,000 (Europe)

84 -173 millions (World)*

6 - 8 millions (USA/Can.)*

14 - 37 millions (Europe)*

208,000 (World) 58,000 (USA/Can.)

61,000 (Europe)

679,000 (World)204,000 (USA/Can.)

202,000 (Europe)

1,3 millions (World)235,000 (USA/Can.)

381,000 (Europe)

1,5 millions (World) 296,000 (USA/Can.)

476,000 (Europe)

13 - 41 millions (World)3 - 4 millions

(USA/Can.)6 - 15 millions (Europe)

625,000 (World)174,000 (USA/Can.)

184,000 (Europe)

2 millions (World)612,000 (USA/Can.)

606,000 (Europe)

4 millions (World)705,000(USA/Can.)1 million (Europe)

AH
BCA-1 or BCA oligo?
AH
What about Breast?
Page 6: Arraygenomics bp may 2012

ArrayGenomics

ArrayGenomics 6

Our “BaKuP” range of arrays are already embedded with our proprietary biomarkers for 3 applications which are Bladder, Kidney and Prostate cancers

Each array, manufactured for us presently by Agilent, can run 8 patients per array with a total of 60K oligonucleotides per patient giving unprecedented coverage and resolution of the critical genomic hotspots

The first application in this “BaKuP” range we are launching is for Bladder cancer detection and monitoring which is called the BCA.

Clinicians in Europe and the USA are not satisfied with either traditional testing methods and/or with new and existing commercial biomarkers as they do not offer either non-invasiveness or high sensitivity for aggressive cancers. The concern of the clinician is to replace or add to the panoply of tests, a test that can let them sleep at night reassured that they will not miss an aggressive or ” bad” cancer

Our first BAC array application offers:-

- Non-invasive test ( urine based)

- Unparalleled sensitivity (98% on aggressive cancers and 90% on low grade cancers)

- User friendly, robust arrays, made to the highest USA manufacturing standards

Key points for our “BaKuP” range of arrays

Page 7: Arraygenomics bp may 2012

ArrayGenomics

ArrayGenomics 7

Bladder cancer diagnostics:

Competition /Comparison of BCA oligo Test to other methods

BCA oligo is the only non-invasive commercial test that compares in sensitivity with the Gold standard, invasive cystoscopy.Sensitivity is a major issue for clinicians especially for aggressive cancers where the BCA app has >98% sensitivity

Page 8: Arraygenomics bp may 2012

ArrayGenomics

ArrayGenomics 8

New competitors

Predictive Biosciences Low sensitivity 34% Run in conjunction with several other tests Complicated scoring process Can only be run in-house by their CLIA lab

Company Issue

Leading Edge Low sensitivity - 40% per molecule so with2nd molecule they can only get to 75% Mrna test that requires amplification which caneasily include bacterial infection Complicated protocol so test can only be run in-house by their CLIA lab

Page 9: Arraygenomics bp may 2012

ArrayGenomics

ArrayGenomics 9

Exact Sciences USA (Colon cancer) Market estimated at $2Billion in 2005.

Genomic Health USA( breast cancer) Market estimated at $3Billion in 2007

Comparables

Page 10: Arraygenomics bp may 2012

ArrayGenomics

ArrayGenomics 10

Scientific Advisory Board

ArrayGenomics has a Scientific Advisory Board comprised of

internationally recognised opinion leaders:

• Professor Olivier CUSSENOT, M.D., Ph.D.

Urology/Oncology – HP Tenon/APHP – France

• Professor Freddie HAMDY, M.D.

Urology/Oncology – Nuffield Dept of Surgery, Univ. of Oxford – RU

* Once USA clinical trials work begins

Page 11: Arraygenomics bp may 2012

ArrayGenomics

ArrayGenomics 11

• Ian Jones founded Array Genomics in 2003. He has previously founded several companies and has over 30 years experience running multinational companies in the molecular diagnostics arena. He obtained his M.B.A. from London University

• Dr Brian Hewitt - Brian obtained his PhD from the University of Montpellier. He has more than 30 years experience in senior management in both medical research and in running 3M healthcare businesses in Europe and in the United States

• A.Karim Sighar *- Karim obtained his Master in Biological Engineering and Molecular Biology Specialisation from the CNAM,Paris. He has over 12 years experience in Microbiology and Molecular Biology laboratories and was formerly responsible for cDNA Bank and BioChips production (2004-2007 Biogemma) and the comparative study of gene expression in plants (1999-2004 RhôBio)

• Dr Stéphane Larré is Senior Clinical Lecturer and Locum Consultant Urological Surgeon at the Nuffield Department of Surgery, University of Oxford UK. He has also worked at the Academic Urology Unit, University of Sheffield, UK and the Urology Department, Hopital Tenon, Paris

• Dr Mansoor Mohammed, a recognised world opinion leader in microarrays, obtained his Phd ‘s from the University of Guelph, Canada and University of California, USA in Genomics. He has held CSO postions in Spectral Genomics( Baylor), Quest and most recently as CEO and CSO CBMX, California. He will facilitate the introduction of the arrays into the US market.

* Direct employee

Key People

Page 12: Arraygenomics bp may 2012

ArrayGenomics

ArrayGenomics 12

Contact

ArrayGenomics S.A.

Ian Jones

20 Avenue Jean Bart – BP 5178960 Voisins le Bretonneux - France

Tel : +33 (0)1 39 44 15 35 Fax : +33 (0)1 39 44 15 [email protected]


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