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20160126 smb novio gendix jack schalken

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Presentation SMB Meeting January 26, 2016 on Novio Tech Campus

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20160126 smb novio gendix jack schalken

  1. 1. NovioGendix; ‘..learning by doing..’ Prof dr Jack A Schalken Co-founder and CSO NovioGendix Dr Willem Melchers Co-founder and CEO NovioGendix
  2. 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. 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. 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. 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. 6. NovioGendix Winnaar van Mercator Award 2009 for Knowledge-Based Entrepreneurship Een spin-off van Radboudumc
  7. 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. 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. 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. 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. 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. 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. 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. 14. The next step; ‘’..Quattro becomes Select MDx..’’
  15. 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. 16. ©2015 All rights reserved Prostate Cancer Test to Select Patients for Biopsy Age 50 Elevated PSA Urologist Urine Biopsy DRE
  17. 17. October 13th 2015;
  18. 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. 19. ©2015 All rights reserved Diagnostics for Urological Cancer 19 Prof. Dr. Jack Schalken