Forward Looking Statements - Immune Therapeutics
Transcript of Forward Looking Statements - Immune Therapeutics
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.
• 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
• 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
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
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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ORLANDOFLORIDAWWW.IMMUNTHERAPEUTICS.COM