one hollis st, suite 232 wellesley, ma 02482 · 2018-05-02 · mission & vision company...

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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

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Company Highlights

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Appendix


*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

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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

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Summary

Appendix


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

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Appendix


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NMI-900Dx:EnablingPrecisionGuidedTrialsStackingtheDeckinOne’sFavor

BloodCancers

SolidCancers

PrecisionMedicine:BloodCancersMostSensitivetoNMI-900

•  Over5,000cancerpatientshavebeenscreenedwiththeNMI-900Dx

•  Eachrepresentsasinglepatient

•  Resultssegregatedintodiscretecancerindications

•  “BloodCancers”showahighdegreeofsensitivitytoNMI-900(exampleinredbox)

•  SolidtumorsshowpromisingpotentialforcombinationtherapywithNMI-900

Nemucore Platform

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WorkingwithClinicalLeaders

•  Phase1b/2clinicaldevelopmentofNMI-900inAMLandHighRisk(HR)MDSo  PrincipalInvestigatorsatMoffittandMemorialSloan-KetteringCancerCenters

•  ExpansionofPhase2willincludePrincipleInvestigatorsfromo  MassachusettsGeneralHospital**andMasseyCancerCenters

Dr.AlanList Dr.DavidSallman

Dr.RossLevine Dr.EytanStein

Nemucore Platform

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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

Nemucore Platform

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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

Nemucore Platform

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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

Nemucore Platform

Mission & Vision

Company Highlights

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Summary

Appendix


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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.

Nemucore Platform

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Appendix


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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

Nemucore Platform

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CurrentTargetableMutationsinAMLIDH:Isocitratedehydrogenase&FLT3:fmsliketyrosinekinase3

Nemucore Platform

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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


Care+Midostaurin


Care

BiopsyrevealsIDH1mutation12%ofpatients

withAML


Care

PatientwithnewlydiagnosedAML

PatientreceivesEnasidenib

PatientreceivesIvosidenib

PatientreceivesMidostaurin

Patientreceivesdrugsnotpreviously

administered

Patient Treatment Paradigm Opportunity for NMI-900

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TargetingUnderservedPopulationswithSignificantCommercialPotential

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Appendix


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

Nemucore Platform

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FiveAreasofCapitalDeploymenttoBuildShareholderValue

Nemucore Platform

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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

Nemucore Platform

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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?

Nemucore Platform

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AMLSupportingData:Compelling45%ClinicalresponsetoAuroraBkinaseinhibitorAZD1152

Nemucore Platform

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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

one hollis st, suite 232 wellesley, ma 02482 · 2018-05-02 · mission & vision company...

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