IMMUNEPHARMACEUTICALS:BuildinganImmuno-InflammationFranchisefocusedonImmuno-Dermatology

April2017

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FORWARDLOOKINGSTATEMENT

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EXECUTIVESUMMARY• ImmunePharmaceuticalsisdevelopinginnovative,highlytargetedtherapeuticsinthe

treatmentofinflammatorydiseases,withaprimaryfocusontheimmuno-dermatologyspace.

Bertilimumabindermatologicalindicationsbullouspemphigoid(orphan)andatopicdermatitis;withanoptionalityininflammatoryconditionslikeIBD

– Positivepreliminarysignalfromopen-labelbullouspemphigoidtrialdemonstratedsignificantreductionindiseaseactivityindex(84%),steroidtaperingtobelow10mgandexcellentsafety

– TwoongoingPhaseIIstudiesinbullouspemphigoid(“BP”)andulcerativecolitis(“UC”),studyinatopicdermatitisinplanning

– FullyhumanmAbdevelopedbyCambridgeAntibodyTechnology(AstraZeneca)

– Novel,first-in-classMOAthattargetsandneutralizeseotaxin-1

– BPsalesworthupto~$500M;currenttherapiesareassociatedwithseverecomplications

– LargepotentialinemergingbiologicmarketformoderatetosevereAD

Nano-cyclosporineisa+1Bopportunitytocompetebothagainstnon-steroids(e.g.Eucrisa)inatopicdermatitisandbiologicsinmoderatepsoriasis,witha505(b)accelerateddevelopmenttrack

• Twospinoffstobefundedseparately:CytoviaOncologyfortheimmuno-oncologyassetsandMaximPharmaceuticalsfocusedonpainandneurology.

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EXECUTIVELEADERSHIPTEAM

DanielTeper,PharmD,MBACEONovartis,GSK,Sanofi,Bionest

MonicaLuchi,MD,MBAEVP,ChiefMedicalOfficerNovartis,Incyte,Mesoblast

MiriBen-Ami,MDPresident,InternationalTeva,Aposense

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Crohn’s&Colitis~$1-2+BPeakSales

DoubleBlindPlacebo(42UCPatients)

MayoDiseaseIndexandmucosalinjury

Ongoingenrollment7sitesinIsrael,1inMoldova,6inRussia

Bullous Pemphigoid~$500MPeakSales

OpenLabel(10-15Patients)Safety,BPDAIImprovement,

andsteroidreduction

Ongoingenrollment2sitesinIsrael,6intheUS(includingCaseWestern,

MountSinai,Duke)

SevereAtopicDermatitis

$1-2+BPeakSales

DoubleBlind(20-30Patients)

PlanningphaseIIinNorthAmerica

BERTILIMUMABISMOVINGFORWARDINPHASEII

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BERTILIMUMAB

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FIRST-IN-CLASSMOAHASSTRONGSCIENTIFICRATIONALEINVARIOUSDISEASESOver1500ScientificPublicationstoDate

• UlcerativeColitis• Crohn’sDisease• Non-AlcoholicSteatohepatitis(NASH)• PrimarySclerosing Cholangitis*• Eonsiophilic gastroenteritis*

• SevereeosinophilicAsthma• Chronicobstructivepulmonarydisorder• Neurodegenerative dseases• Age-relatedmaculardegeneration• Churg andStrauss*• Hypereosinophilic syndrome*• Ovariancancerandothers

• SevereAtopicDermatitis/Eczema• BullousPemphigoid:*rareanddebilitating

blisteringskindisease

Eotaxin-1:Anappropriatedrugtarget

fortreatingmanyinflammatorydisordersBasedon>1500scientific

publications

IMMUNO-DERMATOLOGY

GASTROENTEROLOGY

OTHERDISEASES

Bertilimumab:Firstdrugto

specificallytargetandneutralizeeotaxin-1

• Autoimmunediseasecausingsevereskinblistering

• Estimatedpopulationof60,000intheU.S.andE.U.

• Lackoftreatmentleadstoseverecomplications,

e.g.life-threateningsepsis;BPiscorrelatedwith

twicethemortalityrateofthegeneralelderly

population

• Currenttreatment(highdoseoralsteroidsandhigh

potencytopicalsteroids) associatedwithsevereside

effectssuchasdiabetesandosteoporosis

• Steroidsparingoptionshavetoxicityissues:

immuno- suppressants,IVIgG,Rituxan,andXolair

BULLOUSPEMPHIGOID:ORPHANDISEASEWITHUNMETMEDICALNEED

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Source:Dr.Niel Korman andChardan CapitalMarketsResearch(InitiatingCoverageMarch9,2015).

• Bertilimumabistheonlynovelclinicaldrugcandidatein BP

• Encouragingpreliminarydatafromopen-labelBPtrialdemonstratedsignificant

reductionindiseaseactivityindex(84%),steroidtaperingtobelow10mgandexcellent

safety

• ImmunewilluseinterimresultstosupportanOrphanDrugDesignationapplicationand

toincreasethenumberofpatientseligibleforthetrial

• U.S.andE.U.marketsizecurrentlyestimatedat60,000patients;expectedtoreach

90,000by2025duetopopulationagingandincreaseddiagnosis

• Initialadoptionexpectedinmoderatetoseverepatientsegment(approximatelyone-

thirdoftheBPmarket)

• Closepartnershipwithpatientadvocacygroup,InternationalPemphigoidPemphigus

Foundation(IPPF),willhelpdriveadoption

~$500MOFPEAKSALESINANORPHANINDICATION

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TrialDesign

• Open-labelsinglearmstudy

• 10-15newlydiagnosedandexistingmoderatetosevereBPpatients(recentamendment)

• Drugadministrationof10mg/kg(30min.IVinfusion)ondays0,14,and28andfollow-upuntilday60

PrimaryEndpoint • Safety

SecondaryEfficacyEndpoints

• BPDiseaseAreaIndex(“BPDAI”)• ProportionofpatientswhoachieveareductioninBPDAI

scoreof≥50%atday60comparedtobaseline• Proportionofpatientswho have tapered toprednisonedoseof≤10mg/dayat

day60

SteroidDosage • Concomitantlowdoseoralsteroid(prednisone)startingat30mg/day• Forcedtaperingregime,accordingtoclinicalresponse

Note:StudyNCT02226146.

PHASEIIPROOFOFCONCEPTTRIALOVERVIEWPrimaryEndpoints:Safety,BDPAIandSteroidReduction

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BERTLIMUMABBULLOUSPEMPHIGOIDCASESTUDY:SUBJECT02-01• 66yearoldwhitemale,newlydiagnosedwithBP• Medicalhistoryofdiabetes,diverticulosis,gastroduodenitis,anemia,hyperlipidemia• Concomitantmedicationsincludealongactinginsulin(Lantus),sitagliptin,protonpumpinhibitor

(lansoprazole) andironsupplement• Version3oftheprotocol,only2infusionsbertilimumabgiven• Priortreatment:

– 60mgprednisonex4days,off2days,40mg2days,washedoutfor2weeks

• BPDAIatDay0=58;BPDAIatDay60=3• Patient’slastvisitday60at10mgprednisone,taperedto5mgday67

Bertilmumab CouldPotentiallybeOntheMarketin2020-21fortheBullousPemphigoidIndication• Potential tomove directly into multinationalBPPhase IIb /III registration studyif data is

sufficiently robust

– Tobe initiated on2018andcompleted byendof2019;Potential approval ~2020-1

• 12yearsofregulatoryexclusivityintheU.S.and10yearsintheE.U.

• OpportunityforsevenyearsofexclusivityfromorphandrugdesignationinBP

Dupixent(dupilumab)justapprovedforadultADbytheFDA• Launchpriceof$37K/yearand$3Binpeakannualsales(industryanalysts)• SimilarpathwaytoBertilimumab:bothhumanmAbs;Dupilumabtargetsthe

IL-4andIL-13receptors,knowninducersofeotaxin-1• Significantshiftintreatmentparadigmfollowingpsoriasis,injectablesenterthe

marketformoderate-severeAD

ImmuneisplanningapilotphaseIIstudyofBertilimumabin20-30ADpatients

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SignificantNeedforNewTherapiesinAtopicDermatitisBERTILIMUMAB:OptimalandCompetitiveBiologicinDevelopment

ADaffects15-20%ofchildrenand1-3%ofadultsworldwide

Significanteffectonqualityoflife;sleepdisordersduetoitch,depression,cardiovascular

Currentdrugs(emollients,topicalcorticosteroids,calcineurin inhibitors)havelimitedefficacy,lackofspecificityandnegativesideeffectprofile

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INVESTMENTHIGHLIGHTS

• PhaseIIclinicaltrialsongoingintwoindications

– Encouragingpreliminarydatafromopen-labelbullouspemphigoidtrialdemonstratedsignificantreductionindiseaseactivityindex(84%),steroidtaperingtobelow10mgandexcellentsafety

• OngoingplanningforaphaseIIstudyinatopicdermatitis

• Firstinclass,fullyhumanbiologicwithnovelMOA

• Personalizedmedicineapproach:patientselectionbasedoneotaxin-1levelshasthepotentialtoimproveoutcomes

• Initialindicationstargetingorphandiseases,andmultibillionmarketswithunmetmedicalneed

• Cleancapstructure(nopreferredandlimiteddebt)

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NANOCYCLOSPORINE

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TopicalNano-Cyclosporine:$1-2+BMarketOpportunityinModerateAtopicDermatitis(AD)andModeratePsoriasis

InventedbyProfessorSimonBenita,DirectoroftheInstituteforDrugresearchandHeadoftheSchoolofPharmacy,SchoolofMedicine,HebrewUniversityofJerusalem

• Game-changingtopicalformulationofgoldstandardoralCyA

• Excellentdermalpenetration• Long-termformulationstability• Efficacycomparabletohighpotencysteroid

clobetasolinhumanskinmodelofAD• Nano-TechnologyandProductPatentssupport

exclusivityto2036• 505(b)2accelerateddevelopment• PfizeracquiredAnacorin$5.2Bdealtoaddthe

eczemageltoitsportfolio.