NovioGendix; ‘..learning by doing..’

Prof dr Jack A Schalken

Co-founder and CSO NovioGendix

Dr Willem Melchers

Co-founder and CEO NovioGendix

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..’

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

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…’

Pre-pre fase Business plan Founding NG Series A financing CEO/NG facility2000-2005 2006 11-2006 12-2007 5-2009

‘..Every large fluctuation is associated with (expectations of) PCA3..’All critical work including clinical studies weredone @RUMC

‘..Pre-valorisation era @ RUNMC..’Founding scientists seek business developer

TTT, Term sheet Tango a TroisBGV/PPM Oost-founders-RUNMC

‘my BV’

Most ‘entrepreneurial scientists regarded the new streamlined route towards a spin off as ‘quit an improvement’

NovioGendixWinnaar van

Mercator Award 2009 for

Knowledge-Based Entrepreneurship

Een spin-off van Radboudumc

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’)

• …

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)!

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.

NovioGendix Pipeline

Indication/Sub

strate2010 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

Prognosis/FFPE/L

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)

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

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

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

The next step;

‘’..Quattro becomes Select MDx..’’

©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 CancerProvides actionable results to help guide the decision for biopsy

©2015 All rights reserved

Prostate Cancer Test to Select Patients for Biopsy

Age 50

Elevated

PSAUrologist Urine Biopsy

DRE

October 13th 2015;

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

©2015 All rights reserved

Diagnostics for Urological Cancer

19

Prof. Dr. Jack Schalken