Novio gendix - jack schalken 25032010

From ‘science in practise’ to ’science in business’ Jack A Schalken

AMBITION M2M concentrates all expertise and facilities needed for imaging (molecule-to-man) and translational innovation (bench-to-bed)A) Imaging from molecule-to-man B)Translational research – from bench-to-bedsmall molecule virus ribosome animal cell drosophila mouse Basic Pre- science & Proof of Clinical Globular protein bacterium plant cell mosquito homo clinical sapiens discovery concept Trials testing 10nm 100nm 10 μ 100 μ 1cm 1dm 1m Individualized Production 1 3 Small scale GMP- medicine & Chemical evidence production & synthesis based practice labeling 2 4 Imaging Preclinical imaging Clinical imaging (in vitro / in vivo) (volunteers, patients) Molecular (Sub)cellular Organ & body imaging imaging imaging

New biomarkers for prostate cancer are ‘ready for prime time’Biomarker Substrate Phase 1 Phase 2 Phase 3 Phase 4 Phase 5 Phase 6GSTP1+ Urine/Bx yes yes ongoing ongoing yes nomethylationPCA3DD3 Urine yes yes yes yes End 2006 2007/2008 PROGENSATM PROGENSATM Gen-Probe Gen-Probe CE-markedT2-erg Urine yes yes yes ongoing yes no

Cells inProstatic urethra DRE

‘..Molecular Uroscopy..’Progensa PCA3

2003 •Unique biomarker and urine as specimen (can be obtained non invasively)

‘Science in practise’ (1996-2003)‘Science to business’ (2003-2006) •Diagnocure (2000; PCA3 license from RUNMC) •Genprobe (2003; sublicense PCA3 based molecular diagnostics) •2007; Progensa PCA3 launched

What now? • PCA3 is a ‘specialty’ test • Expertise • Dedicated personel • Facilities • NL needs an Oncology Specialty Lab!! • Solution: found one yourselves • Opportunity meets ambition

‘Times they are a changin’Knowledge valorisation ‘95 & ‘06 • Ad hoc, often attenuating •Pro-active, enabling

NoviogendixA spin off from the Radboud University Nijmegen Medical Center

Noviogendix • Founded November 2006 by two RUNMC scientists and a business developer • First round financing Dec 2007 (Biogeneration Ventures, PPM Oost) • Clear terms between Radboud & Noviogendix • Full transparency • Clearly defined • Negotiations took 6 months (much better than average)

Molecular Diagnostics‘core business’ •Specialty Oncology Laboratory • Extensive panel for infectious diseases • First on the EC market with PrCa marker, -Progensa PCA3- • Expanding prostate cancer test panel • Expanding in other GU(genito-urinary) diseases •Research • Marker IP portfolio GU • Molecular profiling PrCa, RCC, TCC • Target validation (well annotated biorespositories)

Technology & fields ofexpertise • Core technology: molecular/gene based diagnostics •Real time PCR (Roche) •NASBA (Biomerieux) •APTIMA DTS 400 (Genprobe) • Disease focus • Oncology •GU(genito-urinary) • Infectious diseases

Noviogendix y • Good functioning management team (founders) • Efficient and effective marketing and sales team (2) • Key personel for research • 10 people in total • Milestones • > 2000 tests sold • New IPR • Health kennis clusterregeling gemeente Nijmegen • Co-applicant for CTMM & PIDON

Noviogendix OncologySpecialty Laboratory • Netherlands • UK • Germany • Belgium • France • Sweden • Italy • Misc. Overseas (incl south America and Australia)

Noviogendix OncologySpecialty Laboratory

Noviogendix Research

•RU(NMC) together with Health valley and the city of Nijmegen provide good soil for biotechnological initiatives•Growing entrepreneurial spirit at RUNMC•Noviogendix can be ‘launched’ in 2009

Noviogendix Challenges • Strengthen the management team • Be prepared for a second round of financing • Oncology Specialty Laboratory • Move to new facility and get certification • Develop strategy to increase sales • Extend test portfolio • Research • Validation of markers • Explore the licensing opportunities (in- and out-)

Novio gendix - jack schalken 25032010

by UMC St Radboud

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