1. NovioGendix;
‘..learning by doing..’
Prof dr Jack A Schalken
Co-founder and CSO NovioGendix
Dr Willem Melchers
Co-founder and interim CEO NovioGendix

2. S’thing about me
Jack A Schalken
Background
Current job
Research director (‘86)and Professor of
experimental urology
(2001)
CSO Noviogendix (2006)
CSO Oncodrone (2013)
Ambition…
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…’
• Profit for investors, science, RUMC and founders

4. The PCA 3 trail…
Discovery in well annotated Validation clinical specimens (POP)
Clinical study cohort 1 2007
HQ PrCa samples
Validation in sample pre-Bx (test cohort)
(urine)/ proof of principle
1994-1999
Clinical study cohort 2008
2003
(verification/validation
cohort)
CE marked test 2007
FDA pivotal studies 2010
FDA PMA approval 2012
Radboudumc
CUR
Hologic Genprobe

5. An important ‘clinical unmet need’ in PrCa
•
•
11% ; life time risk to be
diagnosed with prostate cancer!
Early diagnostics
• ‘Unmet need’ ; A test that
identifies men with potentially
lethal cancer early in the
disease

6. The Biomarker Pipeline
‘..discovery to clinical validation..’
Clinical unmet need; intended use
Discovery in well annotated
HQ PrCa samples
Validation clinical specimens (POP)
Validation in relevant clinical
sample
-Urine
-Blood
-Tissue
Clinical study cohort 1
(test cohort)
Clinical study cohort 2
(verification/validation cohort)
Test format; RUO/LDT
~ 12 Months
~ 6 Months
~18 Months

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

8. NovioGendix
Winnaar van
Mercator Award 2009 for
Knowledge-Based Entrepreneurship
Een spin-off van Radboudumc

9. 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,
your ‘dead’)
• …

10. 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
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)!

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

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

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

14. 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