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  • 1. ..theentrepreneurial scientistor ..thescientific entrepreneur.. Learning by doing!

2. Sthing about me Jack A Schalken Background Current job Ambition Research director (86)- and Professor of experimental urology (2001) CSO Noviogendix (2006) 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 Logical extension of translational R&D activities at RUMC Profit for investors, science, RUMC and founders 4. Preprefase BusinessplanFoundingNG SeriesAfinancingCEO/NGfacility 20002005 2006 112006 12200752009 ..Everylargefluctuationisassociatedwith (expectationsof)PCA3.. Allcriticalworkincludingclinicalstudieswere done@RUMC ..Prevalorisation era@RUNMC.. Foundingscientistsseek businessdeveloper TTT,TermsheetTangoaTrois BGV/PPMOostfoundersRUNMC myBV Mostentrepreneurialscientistsregardedthenewstreamlined routetowardsaspinoffasquitanimprovement 5. NovioGendix Winnaar van MercatorAward2009for KnowledgeBasedEntrepreneurship 6. 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, youre dead) 7. 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)! 8. Clinical Study 1 2 3 4 2009 1 2 3 4 2010 1 2 3 4 2011 1 2 3 4 2012 1 2 3 4 2013 1 2 3 4 2014 1 2 3 4 2015 1 2 3 4 2008 Quarter Year Service laboratory NovioGendix Pipeline PCa early detection (urine) PCa tissue panel BCa early detection (urine) BCa tissue panel Kidney cancer 1 2 3 4 2009 1 2 3 4 2010 1 2 3 4 2011 1 2 3 4 2012 1 2 3 4 2013 1 2 3 4 2014 1 2 3 4 2015 1 2 3 4 2008 Quarter Year Biomarker discovery Validation Clinical StudyLDT ValidationBiomarker discovery LDT Clinical Study PCA3 Service facility Validation Biomarker discovery LDT Clinical Study CE-test Biomarker discovery Validation LDT Clinical Study CE-test Biomarker discovery Validation LDT CE-test Abbreviations: LDT: Laboratory Developed Test; CE-test: Conformit Europenne-marked test Licensing Activities Product Launch PC-Quattro Quattro 9. Clinical Study 1 2 3 4 2009 1 2 3 4 2010 1 2 3 4 2011 1 2 3 4 2012 1 2 3 4 2013 1 2 3 4 2014 1 2 3 4 2015 1 2 3 4 2008 Quarter Year Service laboratory Pipeline PCa early detection (urine) PCa tissue panel BCa early detection (urine) BCa tissue panel Kidney cancer 1 2 3 4 2009 1 2 3 4 2010 1 2 3 4 2011 1 2 3 4 2012 1 2 3 4 2013 1 2 3 4 2014 1 2 3 4 2015 1 2 3 4 2008 Quarter Year Biomarker discovery Validation Clinical StudyLDT ValidationBiomarker discovery LDT Clinical Study PCA3 Service facility Validation Biomarker discovery LDT Clinical Study CE-test Biomarker discovery Validation LDT Clinical Study CE-test Biomarker discovery Validation LDT CE-test Abbreviations: LDT: Laboratory Developed Test; CE-test: Conformit Europenne-marked test Business Devpt Activities Product Launch PC-Quattro Quattro Goal; discovery and clinical validation of PrCa test (Quattro) (400 patient prospective multicenter study incl PCA3 as comparator) BigDx Platform Comp New Strategy Times they are a changin 10. Oncodrone Est2013 11. Identification of compounds (hits)from compound libraries Screening and selection of compounds in in- vitro EMT assays Determinationofthe toxicity foreachselected compoundtofacilitate followupclinicalresearch Efficacyoftheselected compoundswithin vivo animalmodelsfor thetargetsofEMT Synthesizinganalogous testedinthesameinvitro assays,resultingin superiorefficacyand affinity Fromconcepttodrug Q4 2013 Oncodrone 12. Result of long-standing PP partnership PRIMA FP6project 20042009 Threetargets PRO NET IIproject 20102013 Compound development NGI Preseed Company Formation 20112013 ONCODRONE 13. Vehicle (DMSOcontrol) OCD155 5mg/kg/d,i.p. dorsal ventral Results Bone Metastasis Model 14. What did Ilearn from ..dossierNovioGendix.. Work with an experienced team Take maximal advantage offunding for PPinteractions Appropriate timingoflaunching thecompany Iknew moreor lesswhat Iwastalking about attheBAlevel 15. 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