IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) · IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) Elliot Maza,...
Transcript of IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) · IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) Elliot Maza,...
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CONFIDENTIALNottobeUsedorDistributedWithoutImmune’s Permission
IMMUNEPHARMACEUTICALS(NASDAQ:IMNP)ElliotMaza,President&CEO
January10,2018
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This presentation and oral statements made by representatives of the Companymay contain forward-looking statements regarding future events or the futurefinancial performance of the Company. These statements are based on ourcurrent expectations and are subject to risks and uncertainties that could causeactual results or developments to be materially different from historical resultsor from any future results expressed or implied by such forward-lookingstatements. Factors that may cause actual results or developments to differmaterially include, but are not limited to, the risk that our product candidatesthat appeared promising in early research and clinical trials do not demonstratesafety and/or efficacy in larger-scale or later-stage clinical trials and the risk thatwe will not obtain approval to market any of our product candidates. There canbe no assurance that the Company will ever successfully complete the proposedspin-off of Cytovia Inc., or that the Company will capitalize on strategicalternatives, develop its assets, and generate value for shareholders. Please seeImmune’s filings with the Securities and Exchange Commission for a discussionof important risk factors that could cause actual events or results to differmaterially from those in projections or other forward-looking statements.
ForwardLookingStatement
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Focus:immunologicandinflammatorydiseases
Bertilimumab– Ongoingphase2intwoindications: fullyhuman,anti-eotaxin-1mAb forbullouspemphigoid,ulcerativecolitisandotherindications
NanoCyclo– Late-stagepreclinical: nano-encapsulatedtopicalformulationofcyclosporineforatopicdermatitisandpsoriasis
Newmanagementteam;completed$18MfinancinginQ42017
Spin-outofoncologyassets(Cytovia)inprogress
ExecutiveSummary
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ElliotMaza,JD,CPA,PresidentandCEO
§ Extensiveandsuccessfulexperienceinmanagingmicro-capbiotechanddrugmanufacturingcompanies
TonyFiorino,MD,PhD,CMO/COO
§ Broadexperienceinleadingclinical-stagebiotechcompaniesandaformerfundmanagerwell-versedinfinance
JohnZhang,MD,PhD,VPofR&D
§ 20years’experienceinpreclinical/earlyclinicaldrugdevelopmentinpharmaceutical/biotechindustry
SupportedbyexperiencedconsultantsandKOLsforkeydevelopmentandmanufacturingprograms
NewManagementFocusedonExecution
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ClinicalStagePipelinewithMultipleShotsonGoal
Program Indication Preclinical Phase1 Phase2 Phase3
Bertilimumab
BullousPemphigoid Ongoing
UlcerativeColitis Ongoing
AllergicRhinitis Completed
AllergicConjunctivitis Completed
AtopicDermatitis Phase2ready
Otherinflammatoryconditions Phase2ready
NanocycloAtopicDermatitis Ongoing
Psoriasis Ongoing
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Gastroenterology
Ulcerative Colitis
Crohn’s DiseasePrimary Sclerosing Cholangitis (PSC)Eosinophilic Esophagitis
Re spi ra toryAsthmaChronic obstructive pulmonary disease (COPD)
OphthalmologyVernal Keratoconjunctivitis (VKC) Atopic Keratoconjunctivitis (AKC)Age Related Macular Degeneration (AMD)
De rma tol ogyBullous Pemphigoid Atopic DermatitisCutaneous Drug Eruptions
OncologyGlioblastoma, Prostate and Ovarian CancerCutaneous T-Cell Lymphoma (CTCL)
Neurol ogy Age Related Cognitive Decline
Eotaxin-1ImplicatedinManyInflammatoryDiseases
Eotaxin-1attractseosinophilstositesof
inflammation
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TargetingEotaxin-1– AValidatedRationale
Eotaxin-1isresponsibleforrecruitingeosinophilcellstowardsitesofinjuryorinflammationwheretheyreleaseinflammatorysubstances
Targetingeosinophil-relatedcytokinesisaclinicallyandcommerciallyvalidatedsolution
§ ThreeantibodiestargetingIL-5oritsreceptorapprovedfortreatingasthma
§ Dupilumab approvedforAD,blocksIL-4andIL-13signaling
Butmanypatientsdonotrespondtotheseagents
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Targetingeotaxin-1isadistinctandnovelapproachtomodulatingeosinophil-mediatedinflammation
BertilimumabwasinitiallydevelopedbyCATandwelicenseditfromIco Therapeutics
Blockseotaxin-mediatedeosinophilmigration;activeinanimalmodels
Over100subjectsexposedtodate:over60IV;8intranasal;46ocularwithoutanytreatment-associatedSAEs
Excellentsafetyandtolerabilityprofile
PKprofileconsistentwithbiweeklydosing
Bertilimumab– ANovelApproach
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BertilimumabClinicalStatus
Randomized,placebo-controlled,double-blind
(target42,IV)MayoDiseaseIndex,mucosalinjury
Ongoingenrollment5Israeli&6Russiansites
Open-label,single-arm(target10-15,IV)
Safety,BPDAIimprovement,andsteroidreduction
Ongoingenrollment3Israeli&6USsites
85%reductioninBPDAITotalActivityIndex
Bullous PemphigoidPhase2
UlcerativeColitisPhase2
Randomized,dose-ascending,placebo-controlled,masked(62randomized,ocular)
Safety,suppressionofocularitch,othermeasures
Noefficacyobservedforocularadministration
Randomized,dose-ascending,placebo-controlled,double-blind
(35intranasal,17IV)Changeinnasalcross-sectional
area,othermeasures
Significanteffectsforintranasalapplicationbut
notIV
AllergicRhinitisPhase2
AllergicConjunctivitisPhase2
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Orphanskinconditionthatcauseslarge,fluid-filledblisters;mostcommoninpeopleolderthan60;severediseasecanbelife-threatening
Estimated30,000patients(USandEU)
Typicallytreatedwithhigh-doseprednisonetaperedover6-12months
Second-lineimmuno-suppressantssuchasazathioprine,methotrexateandrituximab(Rituxan®)havetoxicityissues
Largeunmetmedicalneedforasteroid-sparingadjunctiveoralternativetherapy
BullousPemphigoid
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InterimResultsfromOngoingPhase2Study
ActualPrednisoneDose
ExpectedPrednisoneDose(basedonJolyetal,2002)
Subjectsreceivedonaverage2,555mglessprednisone
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Resultsfromfirstsixofintended10-15patients
85%reductioninBPDAITotalActivityIndex(p=0.0096)
Allsubjectsachieveda>50%improvement;4/6with>90%improvement
Excellentsafetyandtolerabilityof3IVbertilimumabdoses(days0and14and28)
Meaninitialprednisonedosewasjust26mg,taperedtoameanof9mgbythelastvisit(p=0.0145)
Subjectssparedover2,500mgprednisoneover84days
Potentialtomovedirectlyintoapivotal,registrationtrial
PositiveInterimPhase2Data
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Over3.5millionpatientswithIBDintheUSandEU
PatientswithmoderatetoseverediseasecyclethroughbiologicssuchasRemicade® (infliximab)andEntyvio® (vedolizumab)
§ Demandforadditionaltreatmentoptions
Eotaxin-1stronglyimplicatedasatargetinIBD
§ Tissueeotaxin-1levelsarecorrelatedwithdiseaseseverity
Eotaxin-1blockadeeffectiveinanimalmodelsofIBD
InflammatoryBowelDisease(IBD)
ControlmAb Anti-eotaxin-1
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Randomized,double-blind,placebo-controlledtrial
42subjects;2:1randomization(23enrolled)
Subjectsscreenedforbaselineeotaxin-1levels
3IVbertilimumabdoses(days0and14and28)
Primaryendpointisclinicalresponse(UCMayoClinicIndex)
Multipleadditionalsafetyandefficacymeasuresbeingassessed
Expectenrollmentthroughmid-2018andun-blindinglate2018-early2019
UlcerativeColitisProof-of-ConceptPhase2
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Completeongoingclinicaltrials
§ BP– endofphase2meetingin2018;willproposesinglepivotalphase2/3registrationstudy
§ UC– ifPoC studypositive,willmovetolargerphase2btrial
Atopicdermatitis
§ Developingsubcutaneousformulation
Asthma
§ Positiveanimaldata
§ ExploringcombinationofbertilimumabwithIL-5blockers
Otherindicationstomoveintoactivepreclinicaldevelopmentin2018
BertilimumabDevelopmentPlans
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Developednewcelllinetoproducebertilimumabinahighlyefficientandscalableprocess
Processdevelopmentlargelycomplete
Requestingproposalsfromcontractmanufacturers
InitiationoftechtransferQ2/2018
Willdevelopsubcutaneousformulationinparallel
GMPproduction-readytargetedforlate2018-early2019at500L-1000Lscale
Pursuingsubstantialnewpatentapplicationsaroundnewmanufacturingprocess
BertilimumabManufacturing
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Alternativestotopicalsteroidsarehighlydesiredforatopicdermatitisandpsoriasis
§ Topicalcalcineurin inhibitors(Protopic andElidel)haveablackboxwarning
§ Topicalcyclosporineneverdevelopedbecauseofinadequateskinpenetration
Ourproprietarynano-encapsulatedformulationenhancesskinpenetrationofcyclosporine
§ AnimalandinvitrodatashowefficacyonparwithtopicalsteroidsorProtopic
WebelieveNanoCycloiseligiblefor505(b)(2)regulatorypathway
FinalformulationselectiontooccurQ1/18,followedbytoxicitystudyandlaunchofclinicalproofofconceptstudyinH2/18
NanoCyclo– NovelTopicalCyclosporine
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2018MilestonesTimeline Event
Q1 Form10filingforCytoviaspin-off
Q1 Patent filingfornewbertilimumabmanufacturingprocess
Q1-Q2 CompleteenrollmentandreportadditionalbertilimumabBPdata
Q2 Begin techtransferofnewmanufacturingprocesstoCMO
Q2 Launchclinic-enablingNanoCyclotoxicitystudy
Mid-2018 Bertilimumabendofphase2FDAmeeting
Mid-2018 CompleteenrollmentinUC study
H2 Launch NanoCyclopsoriasisPoC clinical trial
H2 Completescale-upofnewbertilimumab manufacturingprocess
YE Un-blindbertilimumabUCstudy
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InvestmentProfile
Factor IMNP
Broadproductpipeline § Bert:Morethan13diseasetargets§ NanoCyclo:PsoriasisandAD
Successinclinicaltrials § Twophase2trialsongoing§ 2phase2trialscompleted§ Positiveinterim BPresults§ Over100subjectsexposed
Timelinetoprofitability § Bertilumumab: AimingtolaunchBPpivotaltrialin2019withFDAapprovalin2022
§ NanoCyclo: AimingtolaunchpivotalpsoriasisandAD trialsin2019withFDAapprovalin2023
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InvestmentProfileFactor IMNP
Markets § BP:$500M§ UCandothers:>$1Bn§ NanoCyclo:$500M
Competitive Profile § BP:noapprovedtherapy§ UCandothers:targetpatientswith
higheotaxin-1§ NanoCyclo:safety
Market Exclusivity Multipleissuedpatentswithnewapplicationspendingandtobefiled
FinanceUpdate Completed$18MfinancinginOctober2017
OtherConsiderations Participationinplannedspin-offofCytoviaOncology,Inc.viadividend