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ArrayGenomics
ArrayGenomics 1
Corporate Presentation
May 2011
ArrayGenomics, an innovativemolecular diagnostics companywith new, high performance, cancerspecific assays on multiple advanced diagnostic platforms
ArrayGenomics
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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
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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
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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.
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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)
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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
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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
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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
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Exact Sciences USA (Colon cancer) Market estimated at $2Billion in 2005.
Genomic Health USA( breast cancer) Market estimated at $3Billion in 2007
Comparables
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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
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• 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
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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]