s rm m y m y s ry x - dfon51l7zffjj.cloudfront.net€¦ · o : O J Clin 31, 2013 ( suppl ; t 2525)...
Transcript of s rm m y m y s ry x - dfon51l7zffjj.cloudfront.net€¦ · o : O J Clin 31, 2013 ( suppl ; t 2525)...
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OneHollisStreet,Suite232
Wellesley,MA02482
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Nemucore Platform
Mission & Vision
Company Highlights
Clinical Program
Strategy
Team
Market Opportunity
Capital Deployment
Financials
Summary
Appendix
Intellectual Property
Nemucore’sHistory
Majorityofcancerpatientshavediseasewithnoactionablegeneticalterations.
Nemucorewasfoundedin2008tocreatePrecisionMedicinesforthesepatients.
Nemucore’sVision
Eachindividual’scancerholdstheknowledgetoitsownelimination.
Nemucoreunlocksthisknowledge.
Nemucore’sMission
License,DevelopandCommercializeBest-in-Class
PrecisionMedicinesforHighlyLethalCancers
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• In-licensingtechnologyintegrationdrivenbusinessmodel–mitigatesR&Drisk
• OptiononglobalcommercialrightstoNMI-900and*companiondiagnostic
• Focusedon“PrecisionMedicine”developmentofNMI-900,leveragingsignificantinvestmentsbyGlaxoSmithKlineandCancerResearchUK
• NMI-900andcompaniondiagnosticaddressmultiplecancerindicationso AcuteMyeloidLeukemia(AML)o Myelodysplasticsyndromes(MDS)o Breastcancero Non-smallcelllungcancero Ovariancancer
• EvidenceofclinicalactivityandsafetydataNMI-900Phase1trial
• Potentialforclinicaltrialdataoverthenext18-36months
• RaisingfundstocompletesyndicationofSeriesBFinancing
CompanyHighlights
Nemucore Platform
Mission & Vision
Company Highlights
Clinical Program
Strategy
Team
Market Opportunity
Capital Deployment
Financials
Summary
Appendix
Intellectual Property
*CompanionDiagnosticoptiontermextensionbeingnegotiatedtomatchtheNMI-900term
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NMI-900:InhibitsAuroraBKinaseDisruptingCellDivision
AuroraBKinase
• StrongNMI-900bindingleadstosustainedAuroraBKinaseinhibition
• Stopscancercellsfromdividing,resultingincelldeath
• Potent,reversiblecompetitiveinhibitorofAuroraBKinase
• Synergisticwithchemotherapeutics,targetedandimmuno-therapies
NMI-900Best-in-ClassBindingtoAuroraBKinaseComparedtoOtherAuroraBKinaseInhibitors
NMI-900 CompetitorA CompetitorB CompetitorC
8to24hours <0.5hour <0.25hour <2.6hour
DividingCancerCell
Nemucore Platform
Mission & Vision
Company Highlights
Clinical Program
Strategy
Team
Market Opportunity
Capital Deployment
Financials
Summary
Appendix
Intellectual Property
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• Phase1trialdemonstrated61%clinicalactivity,thehighestrateamongAuroraKinaseInhibitors
o Patientpopulation-heavilypre-treatedsolidtumors
o Administered1-hourIVinfusionM-Feverythreeweeks
o 1patienthadpartialresponseand21patientshadstablediseaseo StudyrunbyleadingcancercentersintheUnitedKingdom
• Safeandwelltoleratedin36patientso Main3/4AdverseEvent(AE)neutropeniaandanemia
o AEswerereversible
• Classicaltrialdesign,performedwithNopatientselection
NMI-900:Phase1ClinicalTrialSummary
Nemucore Platform
Mission & Vision
Company Highlights
Clinical Program
Strategy
Team
Market Opportunity
Capital Deployment
Financials
Summary
Appendix
Intellectual Property
Note:SeeAppendixforadditionalinformation.
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• HolisticapproachtodeterminingsensitivitytoNMI-900
• MeasuresmultiplebiomarkersresponsibleforNMI-900sensitivityandresistance
• Uses“SystemsBiology”algorithmtocalculateanNMI-900DrugResponsePredictor(DRP™)scoreforanindividual’scancer
• Independentofmutationstatus
• Suitableforscreeningallcancerindications• PerformedonaAffymetrixchipinaclinicreadyCLIA-setting
• Enablesprecisionmedicineclinicaldevelopmentprogram
NMI-900:NovelCompanionDiagnosticHighlights
Nemucore Platform
Mission & Vision
Company Highlights
Clinical Program
Strategy
Team
Market Opportunity
Capital Deployment
Financials
Summary
Appendix
Intellectual Property
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NMI-900DRP™:EnablingPrecisionGuidedTrialsStackingtheDeckinOne’sFavor
BloodCancers
SolidCancers
PrecisionMedicine:Chosetheoptimaldrug
combinationtoachievesyntheticlethality
• Over5,000cancerpatientshavebeenscreenedwiththeNMI-900DRP™
• Eachrepresentsasinglepatient
• Resultssegregatedintodiscretecancerindications
• “BloodCancers”showahighdegreeofsensitivitytoNMI-900(exampleinredbox)
• SolidtumorsshowpromisingpotentialforcombinationtherapywithNMI-900
Nemucore Platform
Mission & Vision
Company Highlights
Clinical Program
Strategy
Team
Market Opportunity
Capital Deployment
Financials
Summary
Appendix
Intellectual Property
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WorkingwithClinicalLeaders
• Phase1b/2clinicaldevelopmentofNMI-900inAMLandHighRisk(HR)MDS
o PrincipalInvestigatorsatMoffittandMemorialSloan-KetteringCancerCenters
• ExpansionofPhase2willincludePrincipleInvestigatorsfrom
o MassachusettsGeneralHospital**andMasseyCancerCenters
Dr.AlanList Dr.DavidSallman
Dr.RossLevine Dr.EytanStein
Nemucore Platform
Mission & Vision
Company Highlights
Clinical Program
Strategy
Team
Market Opportunity
Capital Deployment
Financials
Summary
Appendix
Intellectual Property
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Arm1
StudyHighlights:
• 2armtrial
• Patientpopulation:Patientswithrecurrentdiseaseorthoseunsuitableforstandardtherapy
• Phase1Endpoints:Safety&Tolerability
• Phase2aEndpoint:Efficacy
o AMLresponsecriteria
o InternationalWorkingGroupCriteria
• AnalyzepatientbiopsiesforNMI-900DRP™signature
• NumberofpatientsperArm:~20
• TotalTrialbudget:$4M-$5.5M
• NMI-900IVtwiceweekly
• Doseescalation:12patients
• Expansionarmtotal:20+patients
• NMI-900IVweekly
• Doseescalation:12patients
• Expansionarmtotal:20+patients
Phase1b/2Trial
Arm2
**IncollaborationwithMoffittandMemorialSloan-KetteringCancerCenter**
ApplyforFastTrack,BreakthroughTherapyandOrphanDrugDesignations
SummaryAML/HR-MDSClinicalTrialPlan
Nemucore Platform
Mission & Vision
Company Highlights
Clinical Program
Strategy
Team
Market Opportunity
Capital Deployment
Financials
Summary
Appendix
Intellectual Property
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Year1
• ExerciseoptionsonNMI-900andDiagnostic
• AML/HR-MDSTrialinitiation–IND,clinical
materialsanddiagnostic
• InitiatePhase1btrialinAML/HR-MDSo Moffitt&MSKCCo PhysicianInvestigators:Drs.DavidSallman
(Moffitt)&EytanStein(MSKCC)o Safety,Schedule,EfficacyandSensitivity/
Predictivepowerofthediagnostic
• ApplyforOrphanDesignationinAMLand/or
MDS
• MDS-CMMLTrialinitiation–IND,clinical
materialsanddiagnostic
Year2
• ManufacturesecondbatchofNMI-900
• OpenPhase2ofAML/HR-MDStrialo EfficacyandSensitivity/Predictive
powerofthediagnostic
• InterimanalysisofAML/MDSdata
• OpenCombinationMDS–CMMLtrialo Moffitto PhysicianInvestigators:Drs.Eric
PadronandDavidSallmano Safety,Schedule,Efficacyand
Sensitivity/Predictivepowerofthediagnostic
• PreclinicalConfirmSolidTumorSynthetic
LethalCombinationsMGHCC
Year3
• ToplineanalysisofPhase2AML/
MDSdata
• Datawarranting,applyforFast
TrackapprovalinAMLand/orHR-
MDS
• OpenPhase3AMLand/orHR-
MDS
• InitiatePhase1bclinicaltrialin
Ovarian/BreastCancer/Lungo Combinationtrialo Safety,Schedule,Efficacyand
Sensitivity/Predictivepowerofthediagnostic
• ApplyforOrphanDesignationin
selectsolidtumorindications
ClinicalDevelopmentPlan
Nemucore Platform
Mission & Vision
Company Highlights
Clinical Program
Strategy
Team
Market Opportunity
Capital Deployment
Financials
Summary
Appendix
Intellectual Property
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StrategicSummary
• PursueFDAapprovalinindicationsthatNMI-900canbeutilizedasasingleagent
• WorkwithKeyOpinionLeaderstoidentifysolidtumorindicationswherecombinationwithNMI-900leadtosuccessfulFDAapproval
NMI-900andAML/highrisk(HR)-MDSpatients
• NMI-900’suniqueactivityandourbiomarkeranalysisindicateNMI-900couldbeveryeffectiveinAMLandhighrisk-MDSpatients.Plansaretohaveclinicaldatatosupportafast-trackdesignationin24-30months.
• NMI-900AML/HR-MDStrialswillbeconductedatMoffittandMemorialSloan-KetteringCancerCenterswithphase2expansionsitestoincludeMGH,MasseyandFoxChaseCancerCenters.
MilestonesAchieved
• Recruitedtoponcologisttoperformthedesignedclinicaltrials
• SecuredadiagnosticpartnerfortheperformanceoftheNMI-900DRP™companiondiagnostic
• NovellaClinical-AQuintilesCompanyselectedasCROpartnertooverseethetrialexecution
• Sigma-Aldrich,world-classmanufacturingpartnertocreatefuturebatchesofNMI-900
Strategy:UniquelyPositionNMI-900forCommercialSuccess
Nemucore Platform
Mission & Vision
Company Highlights
Clinical Program
Strategy
Team
Market Opportunity
Capital Deployment
Financials
Summary
Appendix
Intellectual Property
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• Exampleexit:CelatorPharmaceuticalsreformulationofstandardofcaretherapiesachieveddatasuperiortostandardofcare(47.7%vs.33.3%,respectively).TwomonthslaterJazzPharmaceuticalspurchasedCelatorfor$1.5B.Fourmonthspriortotheacquisition,Celatorwastradingat~$28Minmarketcapitalization.
• Examplevaluecreatedwithcompaniondiagnostic:June28th2016,TesaroannouncedNiraparib’sPhaseIIINOVOTrialshowedsignificantprogressionfreesurvivalina“stratified”ovariancancerpatientpopulation.Shareholdersgained$2.6Binmarketcapitalizationupontheannouncement.
• Examplevaluelostbecausenocompaniondiagnostic:August28th2016,Bristol-MyersSquibbannouncedtheOpvidoTMCheckmate-026Trialfailedtoachieveitsprimaryendpointina“broad”populationoflungcancerpatients.Shareholderslost$2.2Binmarketcapitalizationupontheannouncement.
• Examplefast-track:NovartiswonapprovalforMidostaurin,thefirsttargetedtherapyforAMLpatientswhocontainaFLT-3mutationwithin18monthsofafast-trackdesignation.
Strategy:UniquelyPositionNMI-900forCommercialSuccess
Nemucore Platform
Mission & Vision
Company Highlights
Clinical Program
Strategy
Team
Market Opportunity
Capital Deployment
Financials
Summary
Appendix
Intellectual Property
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• Careerfocusonmultidrugresistant(MDR)cancertherapydevelopment• Morethan15yearsofindustry,entrepreneurialandleadershipexperience• FormerManagerintheHealthcareAdvisoryPracticeatPwC• FounderandformerCEOofBioCachePharmaceuticals,Inc.
TimothyP.Coleman,PhD,MBA
ChairmanoftheBoard,Founder
President&ChiefExecutiveOfficer
• Morethan30yearsofpharmaceuticalindustryexperienceincludingseniormanagementrolesatWyethandMonsanto• Morethan10yearsofC-Levelexperienceinthecreationanddevelopmentofstart-upcompanies
William“Sandy”White,MBA*
ChiefOperatingOfficer
• FormerHeadofHealthcarePrivateEquityPlacementsatPiperJaffray• Extensiveexperienceinhealthcarefinancingandlaw
ChristopherSwenson,JD,MBA*
ChiefBusinessOfficer
• Senior-levelpharmaceuticalexperienceatAstraZenecaandMillennium• ChiefofNIHLaboratoryofWomen’sHealth• Extensiveoncology,toxicologyandpathologyexperience
BarbaraDavis,VMD,PhD,DACVP*
ChiefScientificOfficer
• Morethan25yearsofexperienceincGMPmanufacturing• ExperienceatEliLilly,Monsanto,Croptech,Chlorogen,andIntegratedProteinTechnologies
DavidWilliams,MS*
SeniorVicePresident,Operations
• Morethan15yearsofexperiencecaringforwomanwithmultidrugresistantcancers• EstablishedtheDivisionofGynecologicOncologyacrossamulti-hospitalnetworkinEasternMassachusetts
AllisonMorseMSN,SCM
DirectorofClinicalAffairs
ManagementTeam
*TodayNemucoreisvirtuallyorganizedwiththemanagementteamparticipatingwhentheirexpertiseisrequired.Compensatedinequity;cashcompensationuponraise.
Nemucore Platform
Mission & Vision
Company Highlights
Clinical Program
Strategy
Team
Market Opportunity
Capital Deployment
Financials
Summary
Appendix
Intellectual Property
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• Careerfocusonmultidrugresistant(MDR)cancertherapydevelopment• Morethan15yearsofindustry,entrepreneurialandleadershipexperience• FormerManagerintheHealthcareAdvisoryPracticeatPwC• FounderandformerCEOofBioCachePharmaceuticals,Inc.
TimothyP.Coleman,PhD,MBA
ChairmanoftheBoard,Founder
President&ChiefExecutiveOfficer
• Morethan35yearsofexecutiveleadershipandboardexperience• President,CEOandFounderofAmericanBaileyCorporation• ExecutiveChairmanoftheBoardofFuelTech,Inc.• FormerDirectorandCompensationCommitteeChair,Endocyte,Inc.
DouglasG.Bailey,SB,SM,ME,MBA
Director,Chairmanofthe
CompensationCommittee
• PartneratPwCformorethan25years• Co-Founderofabillion-dollarhealthcareadvisorypractice
BryanA.Costantino,MBA,MSPA
LeadDirector,Chairmanofthe
AuditCommittee
• Extensivecareerinprivateandpublicinvestmentandfinancesectors• FoundingPartnerTallOaksCapitalPartners;Initiated/oversawstart-ups• FormerAssistanttothePresidentforEconomicDevelopmentofVirginiaCommonwealthUniversity
JamesB.Farinholt,Jr.,BS
Director,Chairmanofthe
NominatingandGovernanceCommittee
• Morethan20yearsofexperienceasapracticingoncologist• CMOofMcKessonSpecialtyHealthandTheUSOncologyNetwork• FormerCEOandPresidentofFoxChaseCancerCenter
MichaelV.Seiden,MD,PhD
Director
LeadClinicalAdvisor
BoardofDirectors
Nemucore Platform
Mission & Vision
Company Highlights
Clinical Program
Strategy
Team
Market Opportunity
Capital Deployment
Financials
Summary
Appendix
Intellectual Property
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• ChiefMedicalOfficerofMcKessonSpecialtyHealthandTheUSOncologyNetwork
• FormerCEOandPresidentofFoxChaseCancerCenter
MichaelV.Seiden
MD,PhD
• ClinicalinstructorintheDept.ofMalignantHematology• Specializesinthedevelopmentofnovel,targetedtherapeuticstrategiesforpatientswithMDSandAML
DavidSallmanMD
• Hemotology-oncologyphysicianspecializinginLeukemias,myelodysplasticsyndromes,andmyeloproliferativeneoplasms
• ActiveclinicalresearcherdevelopingnewapproachestotreatingAML
EytanM.SteinMD
• LaurenceJosephDineenChairinLeukemiaResearch• Director,MSKCenterforHematologicMalignancies
RossL.LevineMD
• PresidentandCEOofMoffittCancerCenter• Internationallyrecognizedforcontributionsindevelopmentofnovel,moreeffectivetreatmentstrategiesforMDSandAML
AlanList
MD
ClinicalAdvisors
Nemucore Platform
Mission & Vision
Company Highlights
Clinical Program
Strategy
Team
Market Opportunity
Capital Deployment
Financials
Summary
Appendix
Intellectual Property
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• 21,290annualU.S.diagnoses,99,000worldwide• 14,180annualU.S.mortalities• 70%diagnosedwithadvanceddisease• Majorityrelapsewithin12-18monthswithPt-resistantdisease
OvarianCancer
• 20,830annualU.S.diagnoses• 10,460annualU.S.mortalities• 38%ofpatientsachieve5-yearsurvival;mediansurvivalis22.8months
AcuteMyeloidLeukemia(AML)
• 231,840annualU.S.diagnoses• 40,290annualU.S.mortalities• TNBCaccountsfor15%ofdiagnosedand25%ofmortalities
BreastCancer–TripleNegativeBreastCancer(TNBC)
• 224,000annualU.S.lungcancerdiagnoses• 80-85%areNSCLC• 10-15%areEGFR+inU.S.,50-90%EGFR+inAsia
Non-SmallCellLungCancer(NSCLC)
• 40-60,000inU.S.and300,000afflictedworldwide• 80-90%ofpatientsareoverageof60
MyelodysplasticSyndrome(MDS)
$1.5BMarket
$7.0BMarket
$1.0BMarket
$1.5BMarket
* “Cowen and Company. Therapeutic Categories Outlook. October 2014”, “SEER.Cancer.gov, Nov. 2015” & “Needham and Company. AML Drug Development Update, April 2016.”
$1.0BMarket
NMI-900ProductsAddressLargeUnmetClinicalNeeds
Nemucore Platform
Mission & Vision
Company Highlights
Clinical Program
Strategy
Team
Market Opportunity
Capital Deployment
Financials
Summary
Appendix
Intellectual Property
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• Compositionofmatterpatentsissued
o Twelveissuedpatentso GlobalprotectionUS,EUandJapan
• Useinthetreatmentofcancerissued
• Formulationpatentissued
• Coversentirefamilyofcandidates
• Diagnosticpatent• Additionalusepatentstobefiled
LicenseAgreementsWillContaintheFollowingIntellectualProperty
Nemucore Platform
Mission & Vision
Company Highlights
Clinical Program
Strategy
Team
Market Opportunity
Capital Deployment
Financials
Summary
Appendix
Intellectual Property
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AreasofCapitalDeploymenttoBuildShareholderValue
Nemucore Platform
Mission & Vision
Company Highlights
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Strategy
Team
Market Opportunity
Capital Deployment
Financials
Summary
Appendix
Intellectual Property
• Capitalwillbedeployedovera36-monthtimeframe
• DrugFinish,PackagingandLabellingo BaxterBioPharmaSolutions
• ClinicalTrials,RegulatoryandDiagnostico Pending:AML/HR-MDSPhase1b/2trialperformedatMoffittandMSKCCrunwithNMI’sCROPartner
o Future:MDS-CMMLPhase1b/2trialperformedatMoffittandMSKCCwithCROoversight
o Future:Ovarian/Breast/LungCancercombinationPhase1b/2trialperformedatMGH,FCCCandMassey
• ManufacturingAdditionalNMI-900o Sigma-Aldrich(SAFC)
• LicensingFeeso NMI-900Licensingfees:CRUK/GSK
o NMI-900DRP™DiagnosticLicensingFees:MedicalPrognosisInstitute
• OperationsandAdministration
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Select Financial Assumptions
Nemucore Platform
Mission & Vision
Company Highlights
Clinical Program
Strategy
Team
Market Opportunity
Capital Deployment
Financials
Summary
Appendix
Intellectual Property
• CurrentcapitalraisetosupportsyndicationofSeriesBFinancing• AML/MDSclinicaltrialsplannedforyears1and2
• AdditionalNMI-900Manufacturing
• AdditionaltrialsinMDS/CMMLaswellasOvarian/Breast/LungPlanned
• SeriesCorpublicofferingin24-36months
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CompanyHighlights
Nemucore Platform
Mission & Vision
Company Highlights
Clinical Program
Strategy
Team
Market Opportunity
Capital Deployment
Financials
Summary
Appendix
Intellectual Property
*CompanionDiagnosticoptiontermextensionbeingnegotiatedtomatchtheNMI-900term
• In-licensingdrivenbusinessmodel–mitigatesR&Drisk
• OptiononglobalcommercialrightstoNMI-900and*companiondiagnostic
• Focusedon“PrecisionMedicine”developmentofNMI-900,leveragingsignificantinvestmentsbyGlaxoSmithKlineandCancerResearchUK
• NMI-900andcompaniondiagnosticaddressmultiplecancerindicationso AcuteMyeloidLeukemia(AML)o Myelodysplasticsyndromes(MDS)o Breastcancero Non-smallcelllungcancero Ovariancancer
• EvidenceofclinicalactivityandsafetydataNMI-900Phase1trial
• Potentialforclinicaltrialdataoverthenext18-36months
• RaisingfundstocompletesyndicationofSeriesBFinancing
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TimothyColeman,PhD,MBAChairman,ChiefExecutiveOfficer,[email protected] NemucoreMedicalInnovations,Inc.OneHollisStreet,Suite232Wellesley,MA02482508-471-4647www.nemucore.com
ContactInformation
Nemucore Platform
Mission & Vision
Company Highlights
Clinical Program
Strategy
Team
Market Opportunity
Capital Deployment
Financials
Summary
Appendix
Intellectual Property
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• StudyHighlightso Earlyefficacysignals-61%clinicalactivity-superiortootherAuroraKinaseInhibitorso HighestresponserateamongAuroraKinaseInhibitorsincomparableclinicstudieso Safeandwelltoleratedo Mostprevalentsideeffectwaspredictableandtreatableneutropenia
• StudyrunbyleadingcancercentersinUK(May2010-June2013)o Sponsor:CancerResearchUK'sClinicalDevelopmentPartnerships(CDP)programo ClinicalTrialSites:LeedsCancerCentreatSt.James'sUniversityHospital,andBartsandThe
LondonSchoolofMedicine§ 36patientswithadvanced/metastaticsolidtumors;nostandardtherapyavailable
o ClinicalTrials.govIdentifier:NCT01118611o Presentedandpublished:ASCO2013;JClinOncology31,2013(suppl;abst2525)
NMI-900:SafeandClinicallyActiveinCancerPatients
Nemucore Platform
Mission & Vision
Company Highlights
Clinical Program
Strategy
Team
Market Opportunity
Capital Deployment
Financials
Summary
Appendix
Intellectual Property
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NMI-900DiagnosticScoreCalculationandTestingaClinicalTrialPatient’sCancer
DiagnosticScore
2. Testcancerpatient’sgeneticmaterial
1. “Program”Affy-chipwithNMI-900diagnosticsignature
NMI-900SensitivityGenes NMI-900ResistanceGenes
3. Calculatepatient’scancerspecificNMI-900DiagnosticScore
4. HowsensitiveisapatientscancertoNMI-900?
Nemucore Platform
Mission & Vision
Company Highlights
Clinical Program
Strategy
Team
Market Opportunity
Capital Deployment
Financials
Summary
Appendix
Intellectual Property
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AMLSupportingData:Compelling45%ClinicalresponsetoAuroraBkinaseinhibitorAZD1152
Nemucore Platform
Mission & Vision
Company Highlights
Clinical Program
Strategy
Team
Market Opportunity
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Appendix
Intellectual Property
• ResponsedurationtoAZD1152vsLDACisillustrated1• Majorissue:Dailydosingx7days(24hourinfusion)
o Cancer.2013Jul15;119(14):2611-9.doi:10.1002/cncr.28113.Epub2013Apr19
ReformulatedAZD1152=AZD2811
AML/HrMDS NCT03217838 July2017
SolidTumor NCT02579226 Oct2015