This document summarizes the history and development of NovioGendix, a biotech startup focused on liquid biopsy diagnostics for urological cancers. It describes how the company was founded in 2006 by Drs. Jack Schalken and Willem Melchers based on their expertise in prostate cancer biomarker discovery and clinical validation. Key milestones included developing the PCA3 test, launching products, completing financing rounds, and building a product pipeline. In 2015, NovioGendix was acquired by MDxHealth to further commercialization of its prostate cancer diagnostic tests. The founders view this as a logical step that allows the technology to have greater impact through an established company in the urology space.

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

2. S’thing about me
Jack A Schalken
Background Current job Ambition…
Research director (‘86)- and
Professor of experimental
urology (2001)
CSO Noviogendix (2007-2015)
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…’
• Profit for investors, science, RUMC and founders

4. Development of the Liquid Biopsy
Concept
PCA3 Discovery
1996 2002 2003 2007
Proof of Concept
Liquid Biopsy Concept
Integrate All Experience/
Expertise in NovioGendix,
Radboundmc Spin Off
PCA3 Launch
12 September 2002
‘ …history…’

5. 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’

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

7. 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 and
back …
• 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’)
• …

8. 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)!

9. Project: ‘..Quattro..’
CE IVD test to predict biopsy outcome, particularly the
presence of significant cancer
Three independent cohorts
• NG0901…discovery..published
• NG1201…validation..under review
• NG1401…CE IVD..june 2015
Quattro performs well in patients with low serum PSA
Best biomarker model1 …peek preview…AUC 0,87!
1 A biomarker is a characteristic that is objectively measured and evaluated as an indicator of normal biological
processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention.

10. NovioGendix Pipeline
Indication/Sub
strate
2010 2011 2012 2013 2014 2015 2016 2017 2018
Prostate Cancer
Early
Diagnosis/urine
Prostate cancer
Prognosis/FFPE/
LiqBx1
Bladder Cancer
Early
Diagnosis/urine
Bladder Cancer
Prognosis/FFPE/
LiqBx1
Renal Cancer
Early
Diagnosis/Urine
Renal Cancer
Discovery-1’Validation-Clinical Validation-LDT- CE-IVD
LDT Circulating RNA 2-BOSS-Companion Dx- Recruitment
Discovery-1’Validation-Clinical Validation LDT CE-IVD
Discovery-1’Validation-Clinical Validation LDT
Discovery-1’Validation-Clinical Validation LDT CE IVD
Program Planning Phase
1) FFPE, Formalin Fixed Paraffin Embedded derived nucleic acid Liq Bx, Liquid Biopsy, Blood derived nucleic acid
2) liquid Bx test for PrCa specific mRNAs in 3 clinical studies (Pharma sponsored)

11. The first product…time for….
J.P. Morgan 33rd Annual Healthcare Conference
When:
January 12, 2015 – January 15, 2015 (all-day)
Where:
San Francisco, CA, USA
Calendar:
Healthcare Investor Conferences

12. What does an entrepreneurial scientist do at J.P. Morgan
33rd Annual Healthcare Conference
• Target; licensee for product or ‘’exit’’
• Being the scientific appendix to BD (Edward van Wezel)
• Prepare Presentation –short, catchy
• Appointments (from our network)
• The days/weeks/months after
• FOLLOW UP !!! Active follow up ( telcon, in person when the opportunity is
there)
• March 22nd at EAU 2015 Madrid; meeting with CEO MDxHealth

13. Why MDx health ?
• Were they the only party that was interested ? No! (3/10
expressed serious interest)
• 100 % urology company
• Presence in the field (ConfirmDx)
• Product pipeline in urological oncology
• Quattro/SelectMDx fits in product portfolio
• ‘’seasonned’’ CEO; direct, pragmatic
• Good match with executive management
• Noviogendix/MDxHealth Nijmegen fits in MDx as RND
location
• MDxHealth and Radboudumc mutually beneficial partnership

14. The next step;
‘’..Quattro becomes Select MDx..’’

15. ©2015 All rights reserved
Serum PSA
>10 ng/ml
3-10 ng/ml
<3 ng/ml
Biopsy
PSA Follow Up
Bx
No Bx
Cut Off
Improve prognostic performance
SelectMDx for Prostate Cancer
Provides actionable results to help guide the decision for biopsy

16. ©2015 All rights reserved
Prostate Cancer Test to Select Patients for Biopsy
Age 50
Elevated
PSA
Urologist Urine Biopsy
DRE

17. October 13th 2015;

18. Conclusion
• 2007-2015; exciting 9 years
• Nijmegen has the infrastructure and experience to be a significant player
in health care start ups (environment is good!)
• Is there a ‘road map’ to success? I doubt that!
• Acquisition by MDxHealth was a logical step
• The team fully merged/blended in MDxHealth
• What is my role?
 I am further away from ‘day to day’ activities
 I thoroughly enjoy my new role (more strategic)
• This was the last presentation on a Noviogendix lay out

19. ©2015 All rights reserved
Diagnostics for Urological Cancer
19
Prof. Dr. Jack Schalken