One Hollis St, Suite 232 Wellesley, MA 02482 · 2018-05-02 · Mission & Vision Company Highlights...
Transcript of One Hollis St, Suite 232 Wellesley, MA 02482 · 2018-05-02 · Mission & Vision Company Highlights...
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OneHollisSt,Suite232Wellesley,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’sVisionEachindividual’scancerholdstheknowledgetoitsownelimination.
Nemucoreunlocksthisknowledge.
Nemucore’sMissionLicense,DevelopandCommercializeBest-in-Class
PrecisionMedicinesforHighlyLethalCancers
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• In-licensingtechnologyintegrationdrivenbusinessmodel–mitigatesR&Drisk
• OptiononglobalcommercialrightstoNMI-900and*companiondiagnostic
• Focusedon“PrecisionMedicine”developmentofNMI-900,leveragingsignificantbigpharmainvestments
• NMI-900andcompaniondiagnosticaddressmultiplecancerindicationso AcuteMyeloidLeukemia(AML)o Myelodysplasticsyndromes(MDS)o Breastcancero Non-smallcelllungcancero Ovariancancer
• EvidenceofclinicalactivityandsafetydataNMI-900Phase1trial
• Potentialfor“Fast-trackEligible”clinicaltrialdataoverthenext18-36months
CompanyHighlights
Nemucore Platform
Mission & Vision
Company Highlights
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Strategy
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*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
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• Phase1trialdemonstrated61%clinicalactivity,thehighestrateamongAuroraKinaseInhibitors
o Patientpopulation–heavilypre-treatedsolidtumors
o Administeredone-hourIVinfusionM-Feverythreeweeks
o Onepatienthadpartialresponseand21patientshadstablediseaseo StudyrunbyleadingcancercentersintheUnitedKingdom
• Safeandwelltoleratedin36patientso Main3/4AdverseEvent(AE)neutropeniaandanemia
o AEswerereversible• Classicaltrialdesign,performedwithNopatientselection
NMI-900:Phase1ClinicalTrialSummary
Nemucore Platform
Mission & Vision
Company Highlights
Clinical Program
Strategy
Team
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Summary
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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
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NMI-900Dx:EnablingPrecisionGuidedTrialsStackingtheDeckinOne’sFavor
BloodCancers
SolidCancers
PrecisionMedicine:BloodCancersMostSensitivetoNMI-900
• Over5,000cancerpatientshavebeenscreenedwiththeNMI-900Dx
• Eachrepresentsasinglepatient
• Resultssegregatedintodiscretecancerindications
• “BloodCancers”showahighdegreeofsensitivitytoNMI-900(exampleinredbox)
• SolidtumorsshowpromisingpotentialforcombinationtherapywithNMI-900
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WorkingwithClinicalLeaders
• Phase1b/2clinicaldevelopmentofNMI-900inAMLandHighRisk(HR)MDSo PrincipalInvestigatorsatMoffittandMemorialSloan-KetteringCancerCenters
• ExpansionofPhase2willincludePrincipleInvestigatorsfromo MassachusettsGeneralHospital**andMasseyCancerCenters
Dr.AlanList Dr.DavidSallman
Dr.RossLevine Dr.EytanStein
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Arm1
StudyHighlights:• 2armtrial
• Patientpopulation:Patientswithrecurrentdiseaseorthoseunsuitableforstandardtherapy
• Phase1Endpoints:Safety&Tolerability
• Phase2aEndpoint:Efficacyo 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
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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
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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
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• Exampleexit:CelatorPharmaceuticalsreformulationofstandardofcaretherapiesachieveddatasuperiortostandardofcare(47.7%vs.33.3%,respectively).TwomonthslaterJazzPharmaceuticalspurchasedCelatorfor$1.5B.Fourmonthspriortotheacquisition,Celatorwastradingat~ $28Minmarketcapitalization.
• Examplevaluecreatedwithcompaniondiagnostic:OnJune28,2016TesaroannouncedNiraparib’sPhaseIIINOVOTrialshowedsignificantprogressionfreesurvivalina“stratified”ovariancancerpatientpopulation.Shareholdersgained$2.6Binmarketcapitalizationupontheannouncement.
• Examplevaluelostbecausenocompaniondiagnostic:OnAugust28,2016Bristol-MyersSquibbannouncedtheOpvidoTMCheckmate-026Trialfailedtoachieveitsprimaryendpointina“broad”populationoflungcancerpatients.Shareholderslost$2.2Binmarketcapitalizationupontheannouncement.
• Examplefast-track:NovartiswonapprovalforMidostaurin,thefirsttargetedtherapyforAMLpatientswhocontainaFLT-3mutationwithin18monthsofafast-trackdesignation.
Strategy:UniquelyPositionNMI-900forCommercialSuccess
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• Careerfocusonmultidrugresistant(MDR)cancertherapydevelopment• Morethan15yearsofindustry,entrepreneurialandleadershipexperience• FormerManagerintheHealthcareAdvisoryPracticeatPwC• FounderandformerCEOofBioCachePharmaceuticals,Inc.
TimothyP.Coleman,PhD,MBAChairmanoftheBoard,FounderPresident&ChiefExecutiveOfficer
• Morethan30yearsofpharmaceuticalindustryexperienceincludingseniormanagementrolesatWyethandMonsanto• Morethan10yearsofC-Levelexperienceinthecreationanddevelopmentofstart-upcompanies
William“Sandy”White,MBA*ChiefOperatingOfficerand
ChiefBusinessOfficer
• Morethan20yearsexperienceinlifesciences• Raisedmorethan$1Binequityanddebt
DanielGeffken,MBA*InterimChiefFinancialOfficer
• 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,SCMDirectorofClinicalAffairs
ManagementTeam
*TodayNemucoreisvirtuallyorganizedwiththemanagementteamparticipatingwhentheirexpertiseisrequired.Compensatedinequity;cashcompensationuponraise.
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• Careerfocusonmultidrugresistant(MDR)cancertherapydevelopment• Morethan15yearsofindustry,entrepreneurialandleadershipexperience• FormerManagerintheHealthcareAdvisoryPracticeatPwC• FounderandformerCEOofBioCachePharmaceuticals,Inc.
TimothyP.Coleman,PhD,MBAChairmanoftheBoard,FounderPresident&ChiefExecutiveOfficer
• Morethan35yearsofexecutiveleadershipandboardexperience• President,CEOandFounderofAmericanBaileyCorporation• FormerExecutiveChairman,PresidentandCEOofFuelTech,Inc.• FormerDirectorandCompensationCommitteeChair,Endocyte,Inc.
DouglasG.Bailey,SB,SM,ME,MBADirector,ChairmanoftheCompensationCommittee
• PartneratPwCformorethan25years• Co-Founderofabillion-dollarhealthcareadvisorypractice
BryanA.Costantino,MBA,MSPALeadDirector,Chairmanofthe
AuditCommittee
• Extensivecareerinprivateandpublicinvestmentandfinancesectors• FoundingPartnerTallOaksCapitalPartners;Initiated/oversawstart-ups• FormerAssistanttothePresidentforEconomicDevelopmentofVirginiaCommonwealthUniversity
JamesB.Farinholt,Jr.,BSDirector,Chairmanofthe
NominatingandGovernanceCommittee
• Morethan20yearsofexperienceasapracticingoncologist• CMOofMcKessonSpecialtyHealthandTheUSOncologyNetwork• FormerCEOandPresidentofFoxChaseCancerCenter
MichaelV.Seiden,MD,PhDDirector
LeadClinicalAdvisor
BoardofDirectors
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• ChiefMedicalOfficerofMcKessonSpecialtyHealthandPresidentTheUSOncologyNetwork
• FormerCEOandPresidentofFoxChaseCancerCenter
MichaelV.SeidenMD,PhD
• ClinicalinstructorintheDept.ofMalignantHematology• Specializesinthedevelopmentofnovel,targetedtherapeuticstrategiesforpatientswithMDSandAML
DavidSallmanMD
• Hematology-oncologyphysicianspecializinginLeukemias,myelodysplasticsyndromes,andmyeloproliferativeneoplasms
• ActiveclinicalresearcherdevelopingnewapproachestotreatingAML
EytanM.SteinMD
• LaurenceJosephDineenChairinLeukemiaResearch• Director,MSKCenterforHematologicMalignancies
RossL.LevineMD
• PresidentandCEOofMoffittCancerCenter• Internationallyrecognizedforcontributionsindevelopmentofnovel,moreeffectivetreatmentstrategiesforMDSandAML
AlanListMD
ClinicalAdvisors
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• 1,100annualU.S.diagnoses• PatientsprogresstoAML
ChronicMyelomonocyticLeukemia(CMML)Ultraorphandrugdesignation
• 20,830annualU.S.diagnoses• 10,460annualU.S.mortalities• 27%ofpatientsachieve5-yearsurvival;mediansurvivalis22.8months
AcuteMyeloidLeukemia(AML)Orphandrugdesignation
• 500,000annualU.S.diagnoses
Future:SolidTumor(Breast,Ovarian&NSCLCancers)
• 40-60,000inU.S.and300,000afflictedworldwide• 80-90%ofpatientsareoverageof60
MyelodysplasticSyndrome(MDS)Orphandrugdesignation
>$100MMarket
>$5BMarket
$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
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CurrentTargetableMutationsinAMLIDH:Isocitratedehydrogenase&FLT3:fmsliketyrosinekinase3
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Nemucore Platform
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NMI-900+CompanionDiagnosticremainsanoptiontoeachpatient
NMI-900isagnostictomutationstatus
BiopsyrevealsNOMUTATION60%ofpatients
withAML
BestSupportiveCareORClinicalTrial
TREATMENTFAILUREorRECURRENTDISEASE
PatientreceivesStandardof
Care
BiopsyrevealsFLT3mutation20%ofpatients
withAML
BiopsyrevealsIDH2mutation8%ofpatientswithAML
PatientreceivesStandardof
Care+Midostaurin
PatientreceivesStandardof
Care
BiopsyrevealsIDH1mutation12%ofpatients
withAML
PatientreceivesStandardof
Care
PatientwithnewlydiagnosedAML
PatientreceivesEnasidenib
PatientreceivesIvosidenib
PatientreceivesMidostaurin
Patientreceivesdrugsnotpreviously
administered
Patient Treatment Paradigm Opportunity for NMI-900
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TargetingUnderservedPopulationswithSignificantCommercialPotential
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AcuteMyeloidLeukemia
(AML)
MyelodysplasticSyndrome
(MDS)
ChronicMyelomonocyticLeukemia(CMML)
R/R1PatientswithdefinedNMI-900diagnosticscores
TargetPopulation
27% DependingonriskgroupRange:0.75-11.3years
10-20%Five-yearsurvival
15,3513~20,8302 ~1,1004Incidenceperyear
10,480 ProgresstoAML ProgresstoAMLDeathsperyear
40-55%
FLT-3Mutation1:Midostaurin25%reductioninriskofdeathIDH1Mutation:Ivosidenib
38%ORR1IDH2Mutation:Enasidenib
40%ORR
None None ApprovedforR/R
SOC1ResponseRate
1R/R=relapserefractorytostandardofcare;SOC=StandardofCare;ORR=Overallresponserate;%ofAMLpatientswithMutations:FLT-3~25%,IDH2~12%,IDH1~8%2NeedhamandCompany.AMLDrugDevelopmentUpdate,April20163https://www.lls.org/facts-and-statistics/facts-and-statistics-overview4https://www.cancer.org/cancer/chronic-myelomonocytic-leukemia/about/key-statistics.html
50% 50%
R/RPatientswithdefinedNMI-900diagnosticscores
R/RPatientswithdefinedNMI-900diagnosticscores
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• Compositionofmatterpatentsissuedo Twelveissuedpatentso GlobalprotectionUS,EUandJapan
• Useinthetreatmentofcancerissued
• Formulationpatentissued
• Coversentirefamilyofcandidates
• Diagnosticpatent• Additionalusepatentstobefiled
LicenseAgreementsWillContaintheFollowingIntellectualProperty
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FiveAreasofCapitalDeploymenttoBuildShareholderValue
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• 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
o NMI-900DiagnosticLicensingFees
• OperationsandAdministration
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KeyCapitalAssumptions
Ø Private,Pre-IPOCompany
Ø AML/MDSclinicaltrialsongoingduringYears1and2
Ø ManufacturingofadditionalNMI-900
Ø MDS-CMMLtrialexpansionplannedforQ2-Q3ofYear2
Ø Solidtumor“match”trialplannedforQ3-Q4ofYear2
Ø FuturefinancingwillbepursuedwithdatafromsuccessfulAML/MDStrial
SelectFinancialInformation
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CompanyHighlights
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*CompanionDiagnosticoptiontermextensionbeingnegotiatedtomatchtheNMI-900term
• In-licensingdrivenbusinessmodel–mitigatesR&Drisk
• OptiononglobalcommercialrightstoNMI-900and*companiondiagnostic
• Focusedon“PrecisionMedicine”developmentofNMI-900,leveragingsignificantBigPharmainvestments
• NMI-900andcompaniondiagnosticaddressmultiplecancerindicationso AcuteMyeloidLeukemia(AML)o Myelodysplasticsyndromes(MDS)o Breastcancero Non-smallcelllungcancero Ovariancancer
• EvidenceofclinicalactivityandsafetydataNMI-900Phase1trial
• Potentialforclinicaltrialdataoverthenext18-36months
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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
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NMI-900DiagnosticScoreCalculationandTestingaClinicalTrialPatient’sCancer
DxScore
2.Testcancerpatient’sgeneticmaterial
1.“Program”Affy-chipwithNMI-900DRPsignature
NMI-900SensitivityGenes NMI-900ResistanceGenes
3.Calculatepatient’scancerspecificNMI-900DRPScore
4.HowsensitiveisapatientscancertoNMI-900?OrCombination?
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AMLSupportingData:Compelling45%ClinicalresponsetoAuroraBkinaseinhibitorAZD1152
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• 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