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CONFIDENTIAL Not to be Used or Distributed Without Immune’s Permission IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) Elliot Maza, President & CEO January 10, 2018

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Page 1: IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) · IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) Elliot Maza, President & CEO January 10, 2018. 2 ... § 20 years’ experience in preclinical/early

CONFIDENTIALNottobeUsedorDistributedWithoutImmune’s Permission

IMMUNEPHARMACEUTICALS(NASDAQ:IMNP)ElliotMaza,President&CEO

January10,2018

Page 2: IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) · IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) Elliot Maza, President & CEO January 10, 2018. 2 ... § 20 years’ experience in preclinical/early

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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

Page 3: IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) · IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) Elliot Maza, President & CEO January 10, 2018. 2 ... § 20 years’ experience in preclinical/early

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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

Page 4: IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) · IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) Elliot Maza, President & CEO January 10, 2018. 2 ... § 20 years’ experience in preclinical/early

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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

Page 5: IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) · IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) Elliot Maza, President & CEO January 10, 2018. 2 ... § 20 years’ experience in preclinical/early

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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

Page 6: IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) · IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) Elliot Maza, President & CEO January 10, 2018. 2 ... § 20 years’ experience in preclinical/early

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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

Page 7: IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) · IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) Elliot Maza, President & CEO January 10, 2018. 2 ... § 20 years’ experience in preclinical/early

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TargetingEotaxin-1– AValidatedRationale

Eotaxin-1isresponsibleforrecruitingeosinophilcellstowardsitesofinjuryorinflammationwheretheyreleaseinflammatorysubstances

Targetingeosinophil-relatedcytokinesisaclinicallyandcommerciallyvalidatedsolution

§ ThreeantibodiestargetingIL-5oritsreceptorapprovedfortreatingasthma

§ Dupilumab approvedforAD,blocksIL-4andIL-13signaling

Butmanypatientsdonotrespondtotheseagents

Page 8: IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) · IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) Elliot Maza, President & CEO January 10, 2018. 2 ... § 20 years’ experience in preclinical/early

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Targetingeotaxin-1isadistinctandnovelapproachtomodulatingeosinophil-mediatedinflammation

BertilimumabwasinitiallydevelopedbyCATandwelicenseditfromIco Therapeutics

Blockseotaxin-mediatedeosinophilmigration;activeinanimalmodels

Over100subjectsexposedtodate:over60IV;8intranasal;46ocularwithoutanytreatment-associatedSAEs

Excellentsafetyandtolerabilityprofile

PKprofileconsistentwithbiweeklydosing

Bertilimumab– ANovelApproach

Page 9: IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) · IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) Elliot Maza, President & CEO January 10, 2018. 2 ... § 20 years’ experience in preclinical/early

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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

Page 10: IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) · IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) Elliot Maza, President & CEO January 10, 2018. 2 ... § 20 years’ experience in preclinical/early

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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

Page 12: IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) · IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) Elliot Maza, President & CEO January 10, 2018. 2 ... § 20 years’ experience in preclinical/early

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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

Page 13: IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) · IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) Elliot Maza, President & CEO January 10, 2018. 2 ... § 20 years’ experience in preclinical/early

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Over3.5millionpatientswithIBDintheUSandEU

PatientswithmoderatetoseverediseasecyclethroughbiologicssuchasRemicade® (infliximab)andEntyvio® (vedolizumab)

§ Demandforadditionaltreatmentoptions

Eotaxin-1stronglyimplicatedasatargetinIBD

§ Tissueeotaxin-1levelsarecorrelatedwithdiseaseseverity

Eotaxin-1blockadeeffectiveinanimalmodelsofIBD

InflammatoryBowelDisease(IBD)

ControlmAb Anti-eotaxin-1

Page 14: IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) · IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) Elliot Maza, President & CEO January 10, 2018. 2 ... § 20 years’ experience in preclinical/early

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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

Page 15: IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) · IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) Elliot Maza, President & CEO January 10, 2018. 2 ... § 20 years’ experience in preclinical/early

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Completeongoingclinicaltrials

§ BP– endofphase2meetingin2018;willproposesinglepivotalphase2/3registrationstudy

§ UC– ifPoC studypositive,willmovetolargerphase2btrial

Atopicdermatitis

§ Developingsubcutaneousformulation

Asthma

§ Positiveanimaldata

§ ExploringcombinationofbertilimumabwithIL-5blockers

Otherindicationstomoveintoactivepreclinicaldevelopmentin2018

BertilimumabDevelopmentPlans

Page 16: IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) · IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) Elliot Maza, President & CEO January 10, 2018. 2 ... § 20 years’ experience in preclinical/early

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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

Page 18: IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) · IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) Elliot Maza, President & CEO January 10, 2018. 2 ... § 20 years’ experience in preclinical/early

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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

Page 19: IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) · IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) Elliot Maza, President & CEO January 10, 2018. 2 ... § 20 years’ experience in preclinical/early

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InvestmentProfile

Factor IMNP

Broadproductpipeline § Bert:Morethan13diseasetargets§ NanoCyclo:PsoriasisandAD

Successinclinicaltrials § Twophase2trialsongoing§ 2phase2trialscompleted§ Positiveinterim BPresults§ Over100subjectsexposed

Timelinetoprofitability § Bertilumumab: AimingtolaunchBPpivotaltrialin2019withFDAapprovalin2022

§ NanoCyclo: AimingtolaunchpivotalpsoriasisandAD trialsin2019withFDAapprovalin2023

Page 20: IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) · IMMUNE PHARMACEUTICALS (NASDAQ: IMNP) Elliot Maza, President & CEO January 10, 2018. 2 ... § 20 years’ experience in preclinical/early

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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