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. Sthing about me Jack A Schalken BackgroundCurrent jobResearch director (86)and Professor of experimental urology (2001) CSO Noviogendix (2006) CSO Oncodrone (2013)AmbitionMake 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 trailDiscovery 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 2012Radboudumc CURHologic 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 samplesValidation clinical specimens (POP)Validation in relevant clinical sample -Urine -Blood -TissueClinical 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 2000-2005Business plan 2006Founding NG 11-2006Series A financing 12-2007TTT, Term sheet Tango a Trois BGV/PPM Oost-founders-RUNMCMost 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 @RUMCCEO/NG facility 5-2009 8. NovioGendix Winnaar van Mercator Award 2009 for Knowledge-Based EntrepreneurshipEen 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 dont 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 Quarter12008 2 341Biomarker discoveryPCa early detection2009 2 3412010 2 341412012 2 3412013 2 341Licensing ActivitiesClinical StudyLDTValidation2011 2 32014 2 342015 2 314Product LaunchCE-test(urine) Biomarker discoveryValidationLDTClinical StudyPCa tissue panel Biomarker discoveryBCa early detectionLDTValidationCE-testClinical Study(urine) Biomarker discoveryBCa tissue panel Kidney cancerBiomarker discoveryLDTValidationValidationLDTClinical StudyCE-testClinical StudyService laboratory Year Quarter12008 2 3412009 2 341PCA3PC-Quattro Abbreviations: LDT: Laboratory Developed Test; CE-test: Conformit Europenne-marked test2010 2 3412011 2 3412012 2 3412013 2 3412014 2 3412015 2 3Service facilityQuattro4 12. Pipeline Year Quarter12008 2 341Biomarker discoveryPCa early detection2009 2 3412010 2 341412012 2 3412013 2 341Licensing ActivitiesClinical StudyLDTValidation2011 2 32014 2 342015 2 314Product LaunchCE-test(urine) Biomarker discoveryValidationLDTClinical StudyPCa tissue panel Biomarker discoveryBCa early detectionLDTValidationCE-testClinical Study(urine) Biomarker discoveryBCa tissue panel Kidney cancerBiomarker discoveryLDTValidationValidationLDTClinical StudyCE-testClinical StudyService laboratory Year Quarter12008 2 3412009 2 341PCA3PC-Quattro Abbreviations: LDT: Laboratory Developed Test; CE-test: Conformit Europenne-marked test2010 2 3412011 2 3412012 2 3412013 2 3412014 2 3412015 2 3Service facilityQuattro4 13. Pipeline Year Quarter12008 2 341Biomarker discoveryPCa early detection2009 2 3412010 2 341412012 2 3412013 2 34Business Devpt ActivitiesClinical StudyLDTValidation2011 2 312014 2 342015 2 314Product LaunchCE-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 ValidationPCa tissue panelBCa early detection (urine) BCa tissue panel Kidney cancerBiomarker discoveryCE-testLDTClinical StudyCE-testBig DxService laboratory Year QuarterClinical StudyPlatform Study Clinical CompLDTValidationLDT12008 2 3412009 2 341PCA3PC-Quattro Abbreviations: LDT: Laboratory Developed Test; CE-test: Conformit Europenne-marked test2010 2 3412011 2 3412012 2 3412013 2 3412014 2 3412015 2 3Service facilityQuattro4 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