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Makingbonemarrowtransplantationssaferandmoreeffective

Patientspecificcell-basedimmunotherapyproducts,asadjunctivetreatmenttohaploidenticalhematopoieticstemcelltransplantation(HSCT),forthetreatmentofbloodcancersandinheritedblooddisorders

Companypresentation,May182017

Amsterdam,TheNetherlandsEuronext(KDS)

Disclaimer

Theseslidesandtheaccompanyingoralpresentationcontainforward-lookingstatementsandinformation.Forward-lookingstatementsaresubjecttoknownandunknownrisks,uncertainties,andotherfactorsthatmaycauseourorourindustry’sactualresults, levelsoractivity,performanceorachievementstobemateriallydifferentfromthoseanticipatedbysuchstatements.Theuseofwordssuchas“may”,“might”,“will”,“should”,“could”,“expect”,“plan”,“anticipate”,“believe”,“estimate”,“project”,“intend”,“future”, “potential”or“continue”,andothersimilarexpressionsareintendedtoidentifyforwardlookingstatements.Forexample,allstatements we makeregarding(i)theinitiation,timing,cost,progressandresultsofourpreclinicalandclinicalstudiesandourresearchanddevelopmentprograms,(ii)ourabilitytoadvanceproductcandidatesinto,andsuccessfullycomplete,clinicalstudies,(iii)thetimingorlikelihoodofregulatoryfilingsandapprovals,(iv)ourabilitytodevelop,manufactureandcommercializeourproductcandidatesandtoimprovethemanufacturingprocess,(v)therateanddegreeofmarketacceptanceofourproductcandidates,(vi)thesizeandgrowthpotentialofthemarketsforourproductcandidatesandourabilitytoservethosemarkets,and(vii)ourexpectationsregardingourabilitytoobtainandmaintainintellectualpropertyprotectionforourproductcandidates,areforwardlooking.Allforward-lookingstatementsarebasedoncurrentestimates,assumptionsandexpectationsbyourmanagementthat,althoughwebelievetobereasonable,areinherentlyuncertain.Allforward-lookingstatementsaresubjecttorisksanduncertaintiesthatmaycauseactualresultstodiffermateriallyfromthosethatweexpected.Anyforward-lookingstatementspeaksonlyasofthedateonwhichitwasmade.Weundertakenoobligationtopubliclyupdateorreviseanyforward-lookingstatement,whetherasaresultofnewinformation,futureeventsorotherwise,exceptasrequiredbylaw.Thispresentationisnot,andnothinginitshouldbeconstruedas,anoffer,invitationorrecommendationinrespectofoursecurities,oranoffer,invitationorrecommendationtosell,orasolicitationofanoffertobuy,anyofoursecuritiesinanyjurisdiction.Neitherthispresentationnoranythinginitshallformthebasisofanycontractorcommitment.Thispresentation isnotintendedtoberelieduponasadvicetoinvestorsorpotentialinvestorsanddoesnottakeintoaccounttheinvestmentobjectives,financialsituationorneedsofanyinvestor.

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Kiadis:companyataglance

• BasedinAmsterdam,TheNetherlands

• NewCEOandCOOaddbusinessandsupplychaintrackrecord

• Strongteam,exCrucell,J&J,Organon,Wyeth,McKinsey,DSM,Sanquin

• EuronextAmsterdam/Brussels,listedin2015raising€35M

• Majorshareholders:LSP,DraperEsprit,Alta

• Analystcoverage:KBCSecurities,Kempen,Edison,RothCapital

• Marketcap:€115M(15May2017)

• YE2016cash:€14.6million

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TEAM

SHARE-HOLDERS

FINANCIALS

Kiadis:neartermandlargeopportunityinHSCT

• IPprotectedpatientspecificcelltherapyproductasadjunctivetohaploidenticalhematopoieticstemcelltransplantation(HSCT)

• OrphanDrugdesignationsUSandEU;targetpopulation28,700patientswithbloodcancersandinheritedblooddisorders

• PhaseII1yeardatasuperiortoliteratureforalternatives,includingPTCy/BaltimoreandZalmoxis(Molmed,EMAapproved)

• FiledwithEMAbasedonPhaseII,(conditional)approvalexpectedH22018;PhaseIIIagainstPTCy/BaltimoreinitiatedforFDA

• Efficient5daymanufacturing,withoutgeneticengineering;easilyintegratedintoexistingtransplantationcenterprocesses

4

BLOCKBUSTER POTENTIAL

SUPERIOR DATA

IN EU MARKET EXPECTED 2019

EFFICIENT SUPPLY CHAIN

UNIQUE PLATFORM

AllogeneicHematopoieticStemCellTransplantation(HSCT)

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Harvestingofdonorstemcellsandimmunecellstoengraftnewbloodand

immunesystem

Conditioningofpatient to

destroydiseasedbloodandimmune

system

Hematopoieticstemcelltransplantation(HSCT):replacetheorgancausingthediseasewithahealthonefromadonor

AllogeneicHSCT:mostlybloodcancers

6Passweg BMT2017(Europe)

Bloodcancers

• Acuteleukemia• Chronicleukemia• Lymphoma• Multiplemyeloma• MDS

Inheritedblooddisorders

• Thalassemia• Sicklecellanemia

Inheritedimmunedisorders

• SCID• Wiskott-Aldrich

Trade-offwithHSCT:needmatureT-cells,yetavoidGVHD

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MaturepotentT-cellsneededforimmediateprotection

MaturepotentT-cellsattackpatienttissue

Reconstitutionofimmunesystemfromdonorstemcells:• NK/B-cells:1-2months• T-cells:6-12months

InfusionofHSCTgraft

GraftVersusHostDisease(GVHD)

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AcuteGVHD

• GradeI/II:manageable

• GradeIII/IV:lifethreatening

ChronicsevereGVHD

• Increasedriskofinfections

• Severelydebilitating,persistsyears

Affectedorgans:• Skin,mouth,eyes,liver,

gastrointestinaltract,lungs

Manifestations:• Rash,scleroderma,ulceration,

erythema,cirrhosis,immunodeficiency

Treatment:• Immunosuppression(e.g.

corticosteroids),anti-infectives

Matureallo-reactiveT-cellsfromdonorattackantigenicallyforeignepithelialtissuesofpatient(MHCclassIIproteins)

HaploidenticalHSCT:donorsavailable,ifGVHDcontrolled

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65%37,000waiting,ofwhich13,000inUS,

manyneverfinddonor

Availability

Historicalstandard:Geneticallymatchedrelated/

unrelateddonors,tolimitGVHD

95%Allparentsandchildrencanbe

donor

Availability

Emergingalternative:Half-matchedhaploidenticaldonors,

yethighinherentGVHDrisk

Moreallo-reactiveT-cells

Source:Lancet2015;DefinedHealth2013

GrowthinhaploidenticalHSCT,duetoPTCy/Baltimore

10

1985 1995 2005 2015

1,000

2,000

3,000

4,000

0

MatchedrelatedMRDMatchedUnrelatedMUDCordbloodHaploidenticalHID

1995 2005 2015

9,000

1,000

3,000

5,000

7,000

0

MatchedrelatedMRDHaploidenticalHIDMatchedunrelatedMUDcordblood

Source:EBMT,CIBMTR

Growthinhaploidenticalatexpenseofmatchedunrelatedandcordblood

US Europe

StrategytoGVHD

HaploidenticalHSCT

Adjunctivedose(afterHSCT)

GVHDtreatment/prophylaxis

ATIR(Kiadis) Prevention(exvivo)

T-celldepleted(‘Safe’HSCT)

Subset ofT-cells:depletedofGVHDcausingT-cells(‘Safe’T-cells)

Noprophylacticimmunosuppressantneeded

Zalmoxis(MolMed)BPX-501(Bellicum)

Treatment(exvivo/inpatient)

T-celldepletedT-cellsgeneticallyengineeredwithsuicideswitch

IfGVHDoccurssuicideagentinfusedtoeliminateT-cells(ganciclovir,rimiducid)

PTCy (‘Baltimoreprotocol’)

Treatment(inpatient)

T-cellreplete(stemcellsandallimmunecells)

None

Post-TransplantCyclophosphamide(PTCy)&immunosuppressanttocontrolalloreactiveT-cellresponse

EnablinghaploidenticalHSCT:depleteT-cellsthatcauseGVHD

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ATIR:adjunctiveinfusionof‘safe’T-cells,28-32dayspostHSCT

12

Step 1 (Day 1–4)

Patient cells inactivated by radiation

Healthy donor

Patient

Immune cells are collected and mixed

Step 3 (Day 5)Step 2 (Day 5)donor

patient

`

InactivateT-cellsfrompatientbyradiation

``

ATIR:remainingdonorimmunecells,infusedonday28-32afterHSCT

AddTH9402*,whichaccumulatesonlyinactivatedT-cells,duetolackofPgP pump

function

GVHDcausingT-cellsdepletedby‘causingGVHDexvivo’;immunecellsagainsttumorandinfectionsretained

*TH9402– proprietaryselectiverhodaminederivative,modifiedtobecomecytotoxicundergreenlight

Mixpatient&donorimmunecells:alloreactiveT-cellsbecomeactivated(MixedLymphocyte

Reaction)

Exposetogreenlight,TH9402becomestoxic:activated

alloreactiveT-cellsarekilled

Knowhow,issuedpatents(till2021),pendingpatents(estimatedtill2036)

Pipeline:ATIR101forbloodcancers,ATIR201forthalassemia

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ATIR201Inheritedblooddisorders

ATIR101Bloodcancers

PhaseI/II PhaseII PhaseIIITrialdesigns- CR-GVH-001(dosefinding)

- CR-AIR-006(historiccontrol)

- CR-AIR-007(efficacy)

- CR-AIR-008(2nd dose)

- CR-AIR-009(randomized,controlled)

- Adultacuteleukemia

- Myeloablativeconditioning

- CD34+stemcell

- CR-BD-001(dosefinding)

- Pediatric βthalassemia

- Myeloablativeconditioning

- αβ T-celldepleted

ATIR101:potentmatureT-cells,yetlowGVHD(1yr)

• noacutegradeIII/IV• 3acutegradeII(13%)• 1chronic(4%)

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ImprovedOverallSurvivalwithATIR

61%

21%

007:CD34+plussingledoseATIR

• Openlabelsinglearm2013-16• 23patients:AML/ALL• 4sitesinCanadaandEU

006:CD34+

• Historicalobservationalcohort2006-13• 34patients,matchedindications/sites• BasedonEMAscientificadvice

CD34+withATIR(007)

CD34+withoutATIR(006)

LowGVHDrelatedtoATIR

ATIRdepletioneffective:potentT-cellsprovidingprotection,yetlowGVHD

ATIR101:filingEMAMarketingAuthorizationApplication(MAA)

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ATMPcertificateApril2015forqualityandnon-clinicaldata

OrphanDrugDesignation(allHSCTindications)

Pediatric InvestigationPlanagreedwithEMA

RapporteursacceptedPhaseIIdatawithhistoricalcontrolforfilingandreview

EMAMAAsubmittedApril2017basedonPhaseII(likeEMAapprovedZalmoxis)(Conditional)approvaltobeexpected2nd half2018

ATIR101:superiorvsEMAapprovedproductZalmoxis(1yr)

HigherSurvival LowerRelapse

9%

30%

42%

20%

Relapse NonRelapseMortality

61%

51%

OverallSurvival

4%7% 6%

AcuteGVHDIII/IV

ChronicGVHD

LowerGVHD

Note:NOTbasedonrandomizedcontrolledtrials*CHMPAssessmentreport(exceptforaGVHD III/IV);CD34+HSCT;74%AML;10%ALL;16%MDS/NHL/HD,

ATIRPhaseII(007),n=23

Zalmoxis(Molmed)PhaseIIdatainEMAfiling,n=36*

Zalmoxis:EUconditionallyapprovedJune2016basedonPhaseIIdataandmatchedhistorical

control

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0%

Objectives:demonstratesuperiorclinicalbenefitandcollectpharmacoeconomical data(cost,daysinhospital,incidenceofsevereinfectionsandqualityoflife)

ATIR101PhaseIII(009)initiated:ATIRversusPTCy/Baltimore

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R

RandomizedControlled(1:1)

Kiadisprotocol:CD34+HSCT+singledoseATIR101

PTCy/Baltimoreprotocol:post-HSCTcyclophosphamide&immunosuppressant

Primaryendpoint:GVHDandRelapseFreeSurvival(GRFS**)

Secondaryendpoints:OS,ProgressionFreeSurvival,RelapseRelatedMortality,TransplantRelatedMortality

Eventdriven:Primaryanalysisat93GRFSevents

195patients*withacuteleukemia45sitesinUS,CanadaandEU

ProtocolandGRFSasendpointalignedwithEMAandFDA(EndofPhaseIImeeting)Trialapprovedinseveralcountries,liningupsites

*Designedandpoweredfor20%differenceinGRFS**SurvivalwithoutchronicGVHDrequiringimmunosuppression,acutegradeIII/IVGVHDandrelapse

ATIR101:superiorGRFSvsliteratureforPTCy (1yr)

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HigherGVHDandRelapseFreeSurvival(GRFS)

Survivalwithout:• ChronicGVHDrequiring

immunosuppression• AcutegradeIII/IVGVHD• Relapse

Compositeendpoint:survival,qualityoflife,futureprognosis

Note:NOTbasedonrandomizedcontrolledtrials*Solh 2016(Atlanta;DRInormalizedGRFS30%;n=128);McCurdy2017(JohnsHopkins;DRInormalizedGRFS38%;n=372);DRIGRFShazardinpublications

57%

36%

GRFSATIRPhaseII(n=23)

PTCy/BaltimoreDRInormalized*

(n=500)PTCy:resultsfromJohnsHopkins(Baltimore)and

Northside (Atlanta)

ATIR101:superiorOSvsliteratureforallogeneicHSCT(1yr)

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HigherOverallSurvival(OS)

Note:NOTbasedonrandomizedcontrolledtrials*Armandetal,Blood2014

9849HSCTpatients(CIBMTR2008-2010):• MRD,non-MRD,MUD,mismatched• PB,BM,cord• Leukaemia,lymphoma,MM,etc• Myeloablative,RIC

Conclusion:DiseaseRiskIndex(DRI)strongestprognosticfactor

61%55%

GRFSATIR101PhaseII(n=23)

AllogeneicHSCT*DRInormalized

(n=9848)

OverallSurvival(Armand2014)

0 6 12 18 24Monthsfromtransplantation

0

20

40

60

80

100

OverallSurvival(%

)

P<0.0001

ATIR101:superiorvsliteratureforPTCy (1yr)

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Note:NOTbasedonrandomizedcontrolledtrial*Ciurea2015(CIBMTRdata);Piemontese2017(EBMTdata),Salomon2012(Atlanta),Ciurea2012;Devillier2016;DiStasi2014;Esquirol2016;Sugita2015**Ciurea2015(CIBMTRdata);McCurdy2017(Baltimore),Devillier2016,Sugita2015(DRInormalizationbasedonArmand2014)

HigherSurvival(OS) ATIRPhaseII(007),n=23

PTCy/BaltimoreAtleast50%AML/ALL*(n=571)

LowerRelapse

9%

30%29%

22%

Relapse NonRelapseMortality

PTCy:resultsfromEBMT/CIBMTRdatabases,JohnsHopkins(Baltimore)andNorthside (Atlanta)

61% 60%57%

OverallSurvival

PTCy/BaltimoreNormalizedforDiseaseRiskIndex**n=158

0%

4%5%

24%

AcuteGVHDIII/IV

ChronicGVHD

LowerGVHD

OverallSurvival Relapse ChronicGVHD

CD34+stemcells(PhaseII)

9% 4%

αβ-T-cellDepleted(literature*)

40% 6%

PTCy(literature**) 29% 24%

Futuretrials:ATIR101asadjunctivetoαβ-TCDand/orPTCy

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+ATIR21%

+ATIR56%

+ATIR57%

…tofurtherimproveOverallSurvival…

…byloweringrelapse…

…withlikelylowimpactonGvHD

Futuretrial

*VerylimitedpublisheddataavailableforadultAML/ALL:EBMT2017poster,Preziosa etal**DRInormalizedCiurea2015(CIBMTRdata);McCurdy2017(JohnsHopkins),Devilier2016,Sugita2015

Futuretrial

Startwithhigherbaseline…

61%

Disease• Anemia duetodefectsinhaemoglobinandredbloodcells• Transfusiondependencyandironoverload,leadingtohighmortality

HSCT• Potentialcureofbloodformingsystem• ATIR201asadjunctivetoaαβ T-celldepletedhaploidenticalHSCT

Trialdesign• Pediatricpatientswithβ-thalassemia major• 10patients

Status• Centers:Regensburg,Tubingen,Manchester,Birmingham,London• TrialapprovedbyauthoritiesinUK&Germany

ATIR201PhaseI/IIinitiated:β-thalassemia

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ATIR:efficientcentralmanufacturing

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Efficientmanufacturingprocess:

5dayprocess;only2operatingdays

Nogeneticengineering

Disposablebags

Modestfacilityrequirements,no/lowcapex:

SimplecleanroomwithLAFcabinets,noviralvectors

OnesiteforUS/CanadaandEuropeeach

SignificantlylowerCOGSandmanufacturingfootprintthangeneticallyengineeredcelltherapyproducts

ATIR:easyfitintoroutinetransplantationcenterprocedures

Apheresis ShiptoKiadis

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Patient&donormaterial42hourholdtime(HypoThermosol)

Finalproductfrozeninliquidnitrogen(>12monthstability)

CentralKiadismanufacturing

Doseatbedside

Shiptohospital

14daysbeforeHSCTconditioning

28- 32daysafterHSCT

Routinelydoneforbonemarrowgraftsandproductsfrombloodbanks

5dayprocess

Annualpotentialfor(improved)haploidenticalHSCT

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1,200 2,000

4,200

8,300

8,400

-

2,000

4,000

6,000

8,000

10,000

12,000

14,000

16,000

18,000

20,000

US Europe

10,000

18,700*

Source:EBMT,CIBMTR,Passweg BMT2017,Besse JOnc Pract 2015,Lancet2015;*IfonlyEU:16,200**Calculationbasedon35%ofpatientsnotfindingamatcheddonor,onlyUSandEU

4,600

Currenthaploidentical

EligibleforHSCT,butnotyettreated**

CurrentMUD&cordblood

ATIRpatentprotection(owned/licensed)

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Seewordfile

Topic Family ClaimedPriorityDate LatestExpirydate

Devicewhichisusedfor photodynamictreatmentintheATIRprocess P014 July19,1996 June18,2017

MethodsoftreatmentforreducingorpreventingGVHDandapharmaceuticalcompositiontobeusedinthismethod

P015 October5,1999 October18,2021

Useoffragmentsorsupernatantfromphotodynamicallytreatedcells forpreparingvaccinesagainsthematologicaltumorsorfortreatinganimmunologicaldisorder

P016 December5,2003

December 2,2024(ifgranted)

Morerhodamine derivatives,theirsynsthesis anduse P019 April2,2001 January 28,2024

ImprovedphotodynamicprocessleadingtoATIRwithimprovedproperties P040 February19,

2015February19,2036(ifgranted)

Kiadiskeyexpectedmilestones

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SubmissiontoEMAofATIR101formarketingauthorizationapproval(done)Updatesonenrollmentandonopeningnewclinicalsites

2017

(Conditional)marketingauthorizationapprovalATIR101inEUInitiateATIR101asadjunctivetoPTCy and/orαβ T-celldepletedHSCTUpdatesonenrollmentandonopeningnewclinicalsites

2018

CommerciallaunchATIR101inEU(Interim)dataonthevariousclinicaltrialsforATIR101andATIR201

2019

Kiadis:neartermandlargeopportunityinHSCT

• Blockbusterpotential,targetpopulation28,700patients

• EUfilesubmitted,launchexpected2019(basedonPhaseII)

• PhaseIIIinitiatedforUSFDAapproval(superiorGRFStoPTCy)

• Upsidepotentialforsurvival(adjunctivetoαβTCDorPTCy)

• Efficientsupplychain

• Experiencednewteamwithbusinessandsupplychaincapabilities

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29

…sothatmanymorepatientswithotherwiseincurablediseaseswillhaveareasonablechanceoflongsurvivalandcure

Dr.E.Donnall ThomasestablishedbonemarrowtransplantationasatreatmentforleukemiaNobelLecture|1990

Additionalinformation

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ATIRproductcharacteristics

Clinicaltrialinformation(April2017)• CR-GVH-001• CR-AIR-007• CR-AIR-008

Other

ATIR101:alloreactiveT-cellsdepleted,potencyretained

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:Finalproductmanufacturedfromdonor:Cellsfromthedonor/startingmaterial

Typical example in CR-AIR-007

Proli

fera

tion

Inde

x (PI

)

Donor Recipient 3rd party CD3/281.0

1.2

1.4

1.6

468

10DonorATIR

Control:nodonorreactivity

Safety:depleted

allo-reactivity

Potency:otherreactivity

retained

FunctionalreleaseassaybasedonQualityTargetProductProfile&CriticalQualityAttributes

ATIR101:T-cellsreactiveagainstinfections&tumorretained

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Donor

ATIR Control

Myb628multimer

CD8T-cells

EBV CMV

CollaborationwithProf.AngelaKrackhardt,Medizinische Klinik III,Klinikum Rechts derIsar,TUMunich,Munich,Germany

ATIR101:T-cellsreactiveagainstEBVretained– examples

ExamplesoftwopatientsinclinicalstudywithATIR:

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EBVreactivationtriggeredresponseof(viralspecific)T-cellsinseveralpatients• IncreaseinCD3+T-cellsdetectedin

peripheralblood• EBVcopynumbersreducedafter

increaseinCD3+T-cells,indicatingeffectiveimmunologicalT-cellresponse.

PhaseICR-GVH-001:OverallSurvival(5year)

Patients:

19withadvancedhematologicalmalignancies(15notinremissionattransplant)

ATIR101doses:

10kcells/kgto5mln cells/kg;30daysafterHSCT

Results:

• 67%OverallSurvivalatmiddledoselevelafter5years

• NoacutegradeIII/IVGVHDrelatedtoATIR101atanydose

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OverallSurvival(OS)

DoseL1-L3

DoseL4-L6

DoseL7

0%

20%

40%

60%

80%

100%

0 6 12 18 24 30 36 42 48 54 60

TimeafterHSCT(months)

3patients;2,6-5Mcells/kg)

7patients,10-130kcells/kg

9patients,320k-2Mcells/kg

Note:un-manipulatedhaplo-identicalDonorLymphocyteInfusioncancausegradeIII/IVGVHDat50kcells/kg.

PhaseIICR-AIR-007:trialcharacteristics&endpoints

Design:open-label,singlearm,multi-center study

Patientpopulation:• AMLorALLinfirstremissionwithhigh-

riskfeaturesorinsecondorhigherremission

• Nosuitablematcheddonor• Haploidentical family

Locations:CA,BE,DE,UK(8sitesintotal)

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Primaryendpoint:• TransplantRelatedMortality(TRM)at6months

Secondaryendpoints:• AcuteandchronicGVHD• Immunereconstitution• Infections• TRM,relapse,OverallSurvival(OS)

Patientfollow-up(per28november 2016):• Median485days(range110– 742)

PhaseIICR-AIR-007:patient &donorcharacteristics

Patientanddonors• N=23patients(HSCT+ATIR101)• Medianpatientage(range):

41years(21-64)• Gender:13female,10male• Mediandonorage(range):33years(21- 61)

Diagnosis

AML:n=16(70%):• 11inCR1• 5inCR2

ALL:n=7(30%):• 4inCR1• 3inCR2

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Riskclassification

Cytogeneticriskprofile1:• Favorable 0• Intermediate 9(39%)• Adverse 14(61%)

Disease-riskindex2:• Lowriskindex 0• Intermediateriskindex 10(43%)• Highriskindex 13(57%)

1Mrozek K,etal.JCO2012,30(36):4515-45232ArmandP,etal.Blood2014,123(23):3664-3671

PhaseIICR-AIR-007:HSCTcharacteristics

Myeloablative conditioning

• TBI(1200cGy;n=11)ormelphalan(120mg/m2;n=12)

• Thiotepa (10mg/kg),fludarabine (30mg/m2

x5d)andATG(2.5mg/kgx4d)

HSCT

• CliniMACS® CD34isolationsystem(MiltenyiBiotec)

• Target:8-11x106 CD34+cells/kg,withmax.of3x104 CD3+cells/kg

Prophylaxis

• NoGVHDprophylaxis

• CMV/EBVmonitoring

• Prophylacticganciclovir/foscarnet (CMV+recipient/donor)

ATIR101infusion

• Day28postHSCT(median)

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PhaseIICR-AIR-007:causesofdeath(April2017)

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PeriodpostHSCT Classification No.ofpts Classificationofcauseofdeath

<6months

Relapse 1

TRM– Infections 2 AdenovirusandJCvirusinfections

TRM– Other 1 Pulmonaryembolism

6-12months

Relapse 1

TRM– Infections 3 Respiratory/pulmonaryinfections/distress

TRM– Other 1 Multi-organfailure

12-24months(ongoing**)

Relapse 2

TRM-Infections 3* Pneumonia/Sepsis/Septicshock

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*All3patientsimmunosuppressed,subsequentlycontractedinfections,leadingtodeath:2patientswhoreceivedun-manipulatedDLI’sandsubsequentlydevelopedsevereGVHD;1patientwithchronicGVHD**Onepatientstillinactivefollowup

Objective: Extendthelengthofprotection(furtherimproveTRM);investigateflexibilityforphysicians(insteadofun-manipulatedDLI)

Design: HSCTfollowedwithATIR101atday30,andadditionaldoseofATIR101atday72

Enrollment: 11outof15patientsenrolledandtreatedwithATIR101:5patientsreceivedonedoseofATIR101and6patientsreceivedtwodoses

Results:Confirmingsafety/efficacyfindingsin001/007withasingledose,notwithtwodoses- Singledose:nogradeIII/IVGVHD(median137daysfollowup)- Twodoses:gradeIII/IVGVHDinsomepatients

Continuation: Remaining4patientstobeenrolledandtreatedwithasingledose,accordingtoprotocol

PhaseIICR-AIR-008:studywithseconddose(April2017)

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Bellicum BPX-501:datainAML/ALL

Caspallo trial(Zhou2014)• 10pts• Pediatric,aged3-17• MostALL• CD34+HSCT• 3outof4patientstreatedwith

rimiducid totreatGVHDdiedfromrelapse(day57,158,552)

Otherpublicdatamostlynon-malignancies,children(GVHDlower)andmixCD34+andαβTCD

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ArthurLahr(April2017)ChiefExecutiveOfficer

• ChiefStrategyOfficerCrucell (NASDAQ/Euronext);headBD,M&AandM&SUS/EU

• BoardSanquin (Dutchbloodbank)• McKinsey&Co,Unilever

Robbert vanHeekerenChiefFinancialOfficer • HeadGlobalFinance&ControlOrganon

JanFeijen (April2017)ChiefOperationsOfficer

• Headoperations&supplychainJ&Jvaccines,Crucell andAvebe

• DevelopmentatGist-Brocades

Jeroen RoversChiefMedicalOfficer

• ChiefMedicalOfficerCeronco Biosciences• DirectorClinicalDevelopmentOrganon

MargotHoppeGeneralCounsel

• 20+yearsincorporatelegalaffairs,includingGist-BrocadesandDSM

Kiadismanagement:industryexperience,allfunctions

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