Forward Looking Statements - Immune Therapeutics

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Transcript of Forward Looking Statements - Immune Therapeutics

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ForwardLookingStatementsThisMemorandumincludes statementsthatare,ormaybedeemedtobe,“forwardlookingstatements,”asdefinedinthePrivate SecuritiesReformActof1995.Theseforward-lookingstatementscanbeidentifiedbytheuseofforwardlookingterminology,includingtheterms“believes,”“estimates,”“anticipates,”“projects,” “expects,” “intends,” “may,”“will,” “seeks” or“should” or,ineachcase, theirnegativeorothervariationsorcomparableterminology,orinrelationtodiscussionsofstrategy,plans,objectives,goals,futureeventsorintentions.Theseforwardlookingstatementsincludemattersthatarenothistoricalfacts.TheyappearinanumberofplacesthroughoutthisPrivatePlacementMemorandumandincludestatementsregardingIssuer’scurrent intentions,beliefsorexpectationsconcerning, amongotherthings,theIssuer’sfutureplansforthe Project,resultsofoperations,financialcondition, prospects,growth,strategiesandthemarketsinwhichtheIssuerintendstooperate.

Bytheirnature,forward-lookingstatementsinvolverisksanduncertaintiesbecause theyrelatetoeventsanddependoncircumstancesthatmayormaynotoccurinthefuture.Forward-lookingstatementsarenotanassuranceoffutureperformance.TheIssuer’sactualresultsofoperationsandfinancialcondition maydiffermateriallyfromthosesuggestedbytheforwardlookingstatementscontainedinthisdocument. Inaddition, eveniftheIssuer’sfutureresultsofoperationsandfinancialconditionareconsistentwiththeforwardlookingstatementscontained inthisdocument,those resultsordevelopmentsmaynotbeindicativeofresultsordevelopmentsinsubsequentperiods.TheinformationinthisPrivatePlacementMemorandum,including, butnotlimitedtotheinformationunder“RiskFactors,”identifiesimportantfactorsthatcouldcausesuchdifferences(including, butnotlimitedto,achangeinoveralleconomicconditions intheUnitedStates,achangeintheIssuer’s financialcondition, changes intaxlawortheinterpretationthereof, interestratefluctuationsandothermarketconditions,andtheeffectofnewlegislationorgovernmentdirectives).

Forwardlookingstatementsinclude,butarenotlimitedto,informationconcerningpossibleorassumedfutureresultsoftheIssuer’soperations setforthunderthesectionentitled“BusinessoftheIssuer”.Such statements,estimatesandprojectionsreflectvariousassumptionsbytheIssuerconcerning anticipatedresultsand aresubjecttosignificantbusiness, financing,economicandcompetitiveuncertaintiesandcontingencies, manyofwhicharebeyondthecontroloftheIssuerandarebaseduponassumptionswithrespecttofuturebusiness decisions thataresubject tochange.Accordingly, therecanbenoassurance thatsuchstatements,estimatesandprojectionswillberealizedor thatactualresultswillnotvaryconsiderablyfromthoseanticipated, expectedorprojected.TheIssuer, itsaccountants, itslegaladvisersanditsagentsoraffiliatesdonotmakeany representationsastotheaccuracyorcompletenessofsuchstatements,estimatesandprojections,orthatanyforecastswillbeachieved.

TheIssuer isnotobligedto,anddoesnotintend to,updateorreviseanyforwardlookingstatementsmadeinthisPrivatePlacementMemorandumwhetherasaresultofnewinformation,futureeventsorotherwise.AllsubsequentwrittenforwardlookingstatementsattributabletotheIssuer,orpersonsactingonbehalfoftheIssuer,areexpresslyqualifiedintheirentiretybythecautionarystatementscontainedthroughout thisPrivatePlacementMemorandum.Asaresultoftheserisks,prospectivepurchasersoftheSharesshouldnotplaceundue relianceontheseforwardlookingstatements.Neithertheforward-lookingstatementsnortheunderlyingassumptionshavebeenverifiedorauditedbyanythirdparty.

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• ImmuneTherapeuticsInc.,wasformedbypatientstoprovideaffordable therapiestotreatchronicoften life-threateningdiseasesthrough theactivationandmobilization ofthebody’s immunesystem.

• TheCompany’sdevelopmentapproachisdesigned tocommercializeourimmunotherapies byprovidingaffordablenon-toxictherapies:utilizingexistingclinicaltrialdata.

About Us:

Corporate Overview

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Lodonal &MENK

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TheCompany's technology platformisbuiltsurrounding twodifferentimmunotherapies, Lodonal™ (LowDoseNaltrexone- LDN)andMethionine-Enkephalin (MENK)

Theseeffortswerepioneeredbyworldrenownedimmunologists: Dr.Nicholas Plotnikoff, Dr.RonaldHerberman,Dr.BernardBihari,AngusDalgleish,IanS.Zagon,Dr.Jill Smith,Dr.BruceCree,Dr.JaredYounger,PatriciaMcLaughlin,andDr.JaquelynMcCandless etc.

Boththerapieshavebeendecadesinthemaking,overfortyclinicaltrialsrun byinstitutions such asthePennsylvania StateUniversityMedicalSchoolatHershey,University ofChicago,StateUniversityofNewYork,andMultipleSclerosis CenteratUCSF.

TechnologyPlatform

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• LODONAL™:Naltrexoneisanopiateantagonist andwhenused initslowdose form,it exhibitsanovelandparadoxeffectsbyreducinginflammationandoxidativestress,activatingorrebalancingtheimmunesystemandinhibitingcancercellproliferation.

• Suppressautoimmunereactions; decreaseinflammatorycytokines.

• SlowsgrowthofmalignantcellsandIncreasesproduction ofT-Cell,Helper,NK,CD4 cells

• Inadditionto its antagonisteffectonthe opiatereceptors,LDNsimultaneouslyhasanantagonisteffectonnon-opioidreceptors.

• Toll-LikereceptorTRL4andTRL9aswellaspreceptors.

• LDNworksonthebody’snaturalopioidsystemtorestoreimmunebalance byShiftingTh1(pro-inflammatory)toTh2(anti-inflammatory)

Lodonal™

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• Methionine-Enkephalin (MENK):asyntheticpeptidethatactivatesnaturalkiller(“NK”)cellsoftheimmunesystemtoseekanddestroycancercells anditsanitit isasmallpeptidenormallymadebynervecellsandimmunecells.

• ProofofconceptestablishedinHIV/AIDS.

• ClinicalTrialsshowedactivityinKaposi’s, lung,melanoma,pancreaticandrenalcancers

• Highsafetyprofile/with improvedqualityoflife

• CostEffectiveTreatment

Methionine-Enkephalin (MENK)

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Compound( Indication( Preclinical( IND4Track( Phase(I( Phase(II( Phase(III( Regulatory(Approval(

Commercialization(Rights(

IRT4101(MENK/OGF(

(Pancreatic(Cancer(

( ( ( ((((((((

( ( TNIB(

(Ovarian(Cancer(

Hepatocellular(Cancer(HIV/AIDS(

IRT4103(LDN(

MS((

( ( ( ((((((((((((

((((((((

( TNIB(

Crohn’s(((UC((Fibromyalgia((Advanced(Cancers((HIV((

! 1 MENK/OGF=MethionineEnkephalin/Opioid Growth Factor2 Tobedosed± gemcitabineinpatientswithpancreatic cancer3 LDN=LowDoseNaltrexone4 Tobedosedincombination withantiviralsinasymptomaticHIVpatients

PIPELINEFORONCOLOGY&IMMUNOLOGY

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• EmergingmarketsaredrivingthetransformationofthepharmaceuticalindustrywithAfrica consideredthefinalfrontierofemergingmarkets.ThebiggesthealthburdeninemergingnationsarecommunicablediseasessuchasHIV/AIDS,malaria,andtuberculosis. Additionally, emergingnationsarenowalsoexperiencingariseinnon-communicablediseases,whichincludecancer,diabetesandinflammatorydiseases.

• Evenwhendrugsareavailableinemergingnations,manyofthedrugsaretooexpensive,toocomplextoadministerandstore,causesignificantsideeffects,andrequireregularmedicaltestingtobeusedsafely.

• ExistingtreatmentforHIV/AIDS,Cancer,andautoimmunediseasessuppressthebody’s immunesystemwhileourimmunotherapyactivates and/orrebalances theimmunesystem.

• Lodonal™; isanon-toxic,affordableandeasytoadministertherapy.

EmergingNations

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• Africahasthefastestgrowingeconomyintheworldtoday.Infact,sixcountriesfromthecontinentmadeitonthelistofthe10fastest-growingeconomiesintheworldtoday.

• AfricahasacombinedGDPof$2.9trilliondollarsandranksfifthintheworld— behindGermany,butaheadofFranceandBrazil.

• TheAfricanpharmaceutical marketisexpected toachieveayear-on-yeargrowthrateof10.6,resulting inpharmaceutical salesof$45billionby2020.

• SouthAfricaandNigeriaboastGDPspercapitabetween$6,000and$11,000.

• MinisterofHealthyandRegulatoryauthoritiesacrossAfricaandotheremergingnationshaveopenedthedoorforlocaldrugapprovalbasedonexisting late stageclinical datawherebothsafetyandefficacyhavebeenshown.

WhyAfrica?

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• HIV/AIDSstillremainsoneofthethreeglobalpublichealththreats.Thisdiseaseresults insubstantialmorbidity,mortality,negativesocioeconomicconsequences,andhumansuffering.

• Thereareanestimated24.7millionpeoplelivingwithHIVinsub-SaharanAfrica,nearly71%oftheglobaltotal.Tencountries—Ethiopia,Kenya,Malawi,Mozambique,Nigeria,South Africa,Uganda,theUnitedRepublicofTanzania,ZambiaandZimbabwe—account for81%ofallpeoplelivingwithHIVintheregionand50%ofthose areinonlytwocountries—NigeriaandSouth Africa.

WhyHIV/AIDS?

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• Twenty-twomillion,orthreeoffivepeople livingwithHIVarestillnotaccessingantiretroviraltherapy.Theproportions ofpeoplewhodonothaveaccesstotreatmentare58%,inSouthAfrica, and80%inNigeria.

• Lodonal™canprovideanaffordablenon-toxicstandaloneoradjuncttreatmentforimprovinggeneralhealthandprognosis inHIV+patientswithadecreaseofopportunistic infectionsforlessthen$.90centsaday.Thereforeimprovingthequalityoflifeofpeoplesufferingfromthischronicdisease.

WhyHIV/AIDS?

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• Cancer isnowoneoftheleadingcausesofdeathindevelopingcountries.Alreadytherearemoredeathsintheworldfromcancer thanfromAIDS,TBandMalariacombined3.

• Itisestimated thatsub-SaharanAfricawillseeapproximatelya1,000,000newcancercasesthisyear2016anditispredicted thatthenumberofnewcaseswilldoublewithinthenextdecade.

• Evenifthecancersweredetected intheearlystages,thereisinadequateaccesstoeffective treatment.

• Therefore, thereisanurgentneed tobosttheimmunityinorderfortheothertherapies ,suchaschemotherapy, tobemoreeffective

• LodonalTM andMENKcanprovideanaffordablenon-toxicstandaloneoradjuncttreatment forimprovinggeneralhealthandprognosisofpatientswithcancer.

WhyCancer?

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• SignedManufacturingAgreementwithLaboratoriesRamoslocatedinManagua,NicaraguaAugust2013• Receivedapproval toexportLodonalTM

issuedfromtheMinistryofHealthfortheRepublicofNicaraguaforthetreatmentofCancer,HIV/AIDSandautoimmune diseases,

• CGMPapproved facility• IssuedCertificateofFreeSalestoExport:

November2013/renewed• TheFederalRepublic ofNigeria• RepublicofEquatorialGuinea• RepublicofMalawi• GaboneseRepublic

ManufacturingMilestones

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NationalAgencyforFoodandDrugAdministrationandControl

06-2014NAFDACgrantedapproval11/6/2014fora90daybridgingtrial“LODONAL™INTHETREATMENTOFSUBJECTSWITHHUMANIMMUNODEFICIENCYVIRUS:TrialNo:89519615

04-2014Submitted Drug Registration ApplicationsAugust 2014 to National Agency for Foodand Drug Administration and Control(NAFDAC)

BridgingTrialApproval

NAFDACRegistration

2014

RegulatoryApprovalNigerianBridgingTrial

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8-2015NAFDAC Grants Import License forLodonal™

5-2015NAFDAC approved 90-Day Bridgingtrial starts enrollment process .

ImportLicense

TrialStart

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12-2015NAFDAC approved 90-Day Bridgingtrial Day-90 concluded.http://nctr.nhrec.net search.phpsearch=Lodonal&submit=Search

09-2015NAFDAC approved 90-Day Bridgingtrial Day-1 initiated.

2014

FirstDosing

NAFDACTrialEnds

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SubmittedDrugRegistrationApplications

11-2015Sixmonth trialasanadjuncttoVIA/Cryotherapy treatmentapprovedNovember20,2015 (estimatedstartdate2/1/2016)

8-2014Product License PMPB/PL432/2 issued byPharmacy, Medicine and Poisons Ministryof Health.

AdjunctTrialApproved

ProductLicense

2016

2014

RepublicofMalawi

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SubmittedDrugRegistrationApplications

2ndQtr-201690dayclinicaltrialestimatedstartdate

12-2014Ministry of Health Approval Lodonal™ forthe treatment of Cancer, HIV Infections,Multiple Sclerosis, etc subject to budgetapproval.

90dayClinicalTrial

ProductLicense

2014

2016

RepublicofEquatorialGuinea

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• SignedDistributorAgreement• GBPharmaHoldings: Africa• AHARPharma:Nigeria,Kenya,Namibia,

Zambia• FidsonHealthcare:Nigeria[LOI]• QianjiangHubeiRepublicofChinaPKand

ToxicologystudiesforMENKforpancreaticandlivercancer.• Estimatedcompletion FirstQuarter

2016• TheBrewerGroup:Egypt,SirLanka

DistributionMilestones

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Lodonal™MarketSize

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LOCALREGULATORYAPPROVAL

GUARANTEES5-10YearExclusivity

HIGHLYEFFICIENTPATHTO

COMMERCIALIZA-TIONANDREVENUE

AFFORDABLE/SAFE/NON-

TOXICTHERAPIES

COLLABORATIONNGO/FOUNDATION/

HMOLOCALDISTRIBUTION

PRICINGWORKINGCLOSELY

WITHLOCALREGULATORYAGENCIES

PROMISINGPIPELINE HIV/AIDS,

OPPORTUNISTICINFECTIONS,CANCER

ImmuneTherapeuticsLeversforSuccessEmergingNations

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CompanyName ImmuneTherapeutics, Inc.Formed April2012Ticker: IMUNSharePrice $.21MarketCap $35,700,000AverageVolume 171,000Float 6,758,000TotalIssued&Outstanding 170,000,000 (insidershold

86%oftheIMUNStock)

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StockOverview

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37NORTHORANGEAVESUTIE#607

ORLANDOFLORIDAWWW.IMMUNTHERAPEUTICS.COM