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Page 1: s rm m y m y s ry x - dfon51l7zffjj.cloudfront.net€¦ · o : O J Clin 31, 2013 ( suppl ; t 2525) rm s m y m y s ry x y . 23 NMI-900 Diagnostic Score Calculation and Testing a Clinical

1

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

Clinical Program

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

Page 24: s rm m y m y s ry x - dfon51l7zffjj.cloudfront.net€¦ · o : O J Clin 31, 2013 ( suppl ; t 2525) rm s m y m y s ry x y . 23 NMI-900 Diagnostic Score Calculation and Testing a Clinical

24

AMLSupportingData:Compelling45%ClinicalresponsetoAuroraBkinaseinhibitorAZD1152

Nemucore Platform

Mission & Vision

Company Highlights

Clinical Program

Strategy

Team

Market Opportunity

Capital Deployment

Financials

Summary

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


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