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