1. ..the entrepreneurial scientist…or
..the scientific entrepreneur..
Learning by doing!

2. S’thing about me
Jack A Schalken
Background Current job Ambition…
Research director (‘86)-
and Professor of
experimental urology
(2001)
CSO Noviogendix (2006)
CSO Oncodrone (2013)
Make a difference in
diagnosis and
treatment
‘..personalized medicine..’

3. Why NovioGendix ?
• Co-founders were early developers and users of
(molecular) Dx
• Gap between research-(RUO), LDT- and IVD-clinical test
• Co-founders combined respective expertise of discovery
and clinical validation with - implementation
• Growing support in the market
• ‘…the PCA3 case…’
• Logical extension of translational R&D activities at RUMC
• Profit for investors, science, RUMC and founders

4. Pre-pre fase Business plan Founding NG Series A financing CEO/NG facility
2000-2005 2006 11-2006 12-2007 5-2009
‘..Every large fluctuation is associated with
(expectations of) PCA3..’
All critical work including clinical studies were
done @RUMC
‘..Pre-valorisation era @ RUNMC..’
Founding scientists seek
business developer
TTT, Term sheet Tango a Trois
BGV/PPM Oost-founders-RUNMC
‘my BV’
Most ‘entrepreneurial scientists regarded the new streamlined
route towards a spin off as ‘quit an improvement’

5. NovioGendix
Winnaar van
Mercator Award 2009 for
Knowledge-Based Entrepreneurship

6. Critical steps
• Negotiate and settle terms with Radboudumc (‘..we were front
runners..’)
• Dedicated lab space (pre-NovioTech ..)
• Hand picked and committed employees/employees on NG contracts
• From founding management team to an MT led by new full time CEO
• From ’green rookies’ to entrepreneurial scientists with their first
experiences gained and illusions lost, like..
• If you don’t deliver you dilute
• No ‘freebies’ in this business
• Learn the language of Business Administration
• E.g. an ‘EXIT’ is not synonymous with ‘The End’
• A bridge financing is like a life support system (i.e. if you pull the plug,
you’re ‘dead’)
• …

7. The money thing….
• Take ‘€ burn rate’ seriously
• Anticipate to (additional) financing needs
• Prepare well for the discussion with the existing share holders
• Understand relative position of the partners (VCs, founders, RUMC)
• Understand the financing instruments (CLA, new shares..)
• Financial planning should be realistic rather than optimistic
• Take advantage of ‘grants’
• WBSO
• CTMM/PCMM partner
• ETB/ARIBCA partner
• EFRO/UltrasenseMR partner
• Only do so when they fit within business plan of the company (since,
usually the grants require in kind and/or cash contribution from SME)!

8. Clinical Study
1 2 3 4
2009
1 2 3 4
2010
1 2 3 4
2011
1 2 3 4
2012
1 2 3 4
2013
1 2 3 4
2014
1 2 3 4
2015
1 2 3 4
2008
Quarter
Year
Service laboratory
NovioGendix Pipeline
PCa early detection
(urine)
PCa tissue panel
BCa early detection
(urine)
BCa tissue panel
Kidney cancer
1 2 3 4
2009
1 2 3 4
2010
1 2 3 4
2011
1 2 3 4
2012
1 2 3 4
2013
1 2 3 4
2014
1 2 3 4
2015
1 2 3 4
2008
Quarter
Year
Biomarker discovery Validation Clinical StudyLDT
ValidationBiomarker discovery LDT Clinical Study
PCA3
Service facility
Validation
Biomarker
discovery
LDT Clinical Study CE-test
Biomarker
discovery
Validation LDT Clinical Study CE-test
Biomarker
discovery
Validation LDT CE-test
Abbreviations: LDT: Laboratory Developed Test; CE-test: Conformité Européenne-marked test
Licensing Activities Product
Launch
PC-Quattro Quattro

9. Clinical Study
1 2 3 4
2009
1 2 3 4
2010
1 2 3 4
2011
1 2 3 4
2012
1 2 3 4
2013
1 2 3 4
2014
1 2 3 4
2015
1 2 3 4
2008
Quarter
Year
Service laboratory
Pipeline
PCa early detection
(urine)
PCa tissue panel
BCa early detection
(urine)
BCa tissue panel
Kidney cancer
1 2 3 4
2009
1 2 3 4
2010
1 2 3 4
2011
1 2 3 4
2012
1 2 3 4
2013
1 2 3 4
2014
1 2 3 4
2015
1 2 3 4
2008
Quarter
Year
Biomarker discovery Validation Clinical StudyLDT
ValidationBiomarker discovery LDT Clinical Study
PCA3
Service facility
Validation
Biomarker
discovery
LDT Clinical Study CE-test
Biomarker
discovery
Validation LDT Clinical Study CE-test
Biomarker
discovery
Validation LDT CE-test
Abbreviations: LDT: Laboratory Developed Test; CE-test: Conformité Européenne-marked test
Business Devpt Activities Product
Launch
PC-Quattro Quattro
Goal; discovery and clinical validation
of PrCa test (Quattro)
(400 patient prospective multicenter
study incl PCA3 as comparator)
Big Dx
Platform
Comp
New
Strategy
Times they are a
changin’

10. Oncodrone Est 2013

11. Identification of
compounds
(hits) from
compound
libraries
Screening and
selection of
compounds in
in-vitro ‘EMT
assays’
Determination of the
toxicity for each selected
compound to facilitate
follow-up clinical research
Efficacy of the selected
compounds with in
vivo animal models for
the targets of EMT
Synthesizing analogous
tested in the same in-vitro
assays, resulting in
superior efficacy and
affinity
From concept to drug
Q4 2013
Oncodrone

12. Result of long-standing PP partnership
PRIMA FP6 project
2004-2009
Three targets
PRO-
NET
II project
2010-2013
Compound
development
NGI-
Preseed
Company
Formation
2011-2013
ONCODRONE

13. Vehicle
(DMSO control)
OCD155
5mg/kg/d, i.p.
dorsal ventral
Results Bone Metastasis Model

14. What did I learn from
‘..dossier NovioGendix..’
• Work with an experienced team
• Take maximal advantage of funding for PP interactions
• Appropriate timing of launching the company
• I knew ‘’more or less’what I was talking about at the BA level

15. Conclusions
• We were and are still enthusiastic
• Academic spin offs can create ’win win’ situations
• Being an entrepreneurial scientist does not threaten your
scientific output (rather the opposite is true)
• You have to acquire BA ‘skills’
• A constructive relation with the investors is beneficial for
the company as a whole
• The Nijmegen campus is now fully ‘equiped’ to house and
launch biotech companies
• It is mighty helpful if you are like a sheep with five legs