PRESENTATION OF PHASE 2 CLINICAL TRIAL RESULTS

18 December 2018 Phase 2b OA/BMEL Clinical Trial Results Presentation Disclaimer 2 This document, together with any information communicated by Paradigm Biopharmaceuticals Ltd (known as “Paradigm”, “Paradigm Biopharma” or “the Company”), in any presentation or discussion relating to this document (collectively, “Information”) is confidential, and has been prepared by the Company on the condition that it is for the exclusive information and use of the recipient. The Information is proprietary to Paradigm and may not be disclosed to any third party or used for any other purpose without the prior written consent of the Company. The Information is based upon management forecasts and reflects prevailing conditions, which are accordingly subject to change. In preparing the Information, the Company has relied upon and assumed, without independent verification, the accuracy and completeness of all information available from public sources, or which was otherwise reviewed by it. In addition, the analyses are not and do not purport to be appraisals of the assets, stock or business of the Company. Even when the Information contains a kind of appraisal, it shouldbe considered preliminary, suitable only for the purpose described herein and should not be disclosed or otherwise used without theprior written consent of Paradigm. The Information is provided on the understanding that unanticipated events and circumstances mayoccur which may have significant valuation and other effects. December 2018Results Presentation Corporate Overview 3 §ParadigmBiopharmaceuticalsLtdisanASX-listed biotechnologycompanyfocusedonrepurposing pentosanpolysulfatesodium(PPS),anFDA-approved drugthathasalongtrackrecordofsafelytreating inflammation §Drugrepurposingusesthe505(b)(2)pathway-lower cost, minimises risk and has accelerated developmenttimelines §Several clinical indications such as Osteoarthritis/BoneMarrowEdemaLesions,MPS, RossRivervirusandChikungunya,givesParadigm “multipleshotsongoal” §Strategyistoestablishcommercialpartnershipswith multipleleadingpharmaceuticalcompanies Financial Information Shareprice (13-December-2018) A$1.32 Number of shares 139.8m Market capitalisation A$184m Cash(Dec 2018) –no debt ~A$10.5m Shares (m) % Paul Rennie (Managing Director) 21.6 15.4% MJGD Nominees (technology vendor) 6.9 4.9% Other Board and management 7.1 5.1% Irwin Biotech (technology vendor) 6.3 4.5% J.P. Morgan Nominees Aust Pty Ltd 4.2 3.0% Citicorp Nominees Pty Ltd 3.2 2.3% Top shareholders1,2 Note: 1. Blue shading represents Board and management holdings 2. MJGD Nominees and Irwin Biotech are select vendors of Xosoma,which was acquired by Paradigm prior to listing Results Presentation Price ($)Volume (M) December 2018 0 0.5 1 1.5 2 0 0.5 1 1.5 2 12/13/ 20171/13/ 20182/13/ 20183/13/ 20184/13/ 20185/13/ 20186/13/ 20187/13/ 20188/13/ 20189/13/ 201810/13/ 201811/13/ 2018 Osteoarthritis Pain 4 Osteoarthritis –Facts and Figures § Mostcommonformofjointdiseaseandtheleadingcauseofdisabilityforpeoplegreaterthan65yearsofage1 § OAisaprogressivediseasestronglycorrelatedwithbonemarrowedemalesions(BMEL),affectingtheentire joint,includingsynovialinflammation,cartilagelossandboneremodelling § Blockbustermarket–31mAmericanshavebeendiagnosedwithOA-~10%ofthetotalpopulation2 § Significantcost–OAcurrentlycoststheUSeconomy~US128+billionperannum3 § Growingcrisis–DuetoanagingpopulationandhighobesityratesthenumberofOAsufferersintheUSis expectedtoexceed67m(116%growth)by20304 § Significantlimitations,inefficacy,tolerabilityandsafetyofavailabletreatmentsforpatientswithmoderate– severeOA § OpioidEpidemic–TheUSandAustraliaareexperiencingunprecedentedopioidaddictionandoverdoses.The FDAishighlysupportiveofnew,safeandeffective,non-opioidtreatmentsforpain § TimingofPhase3critical-Thereisatime-limitedmarketopportunityforsafeandeffectivenon-opioidnon- steroidaltherapiestotreatmoderate–severeOA. Results Presentation Osteoarthritis is the last frontier of blockbuster diseases with no treatment December 2018 1.Neogi T. (2013). The epidemiology and impact of pain in osteoarthritis.Osteoarthritis and cartilage,21(9), 1145-53.2. http://ard.bmj.com/content/annrheumdis/early/2017/07/12/annrheumdis-2017-211396.full.pdf 3. National Institute of Health; Emerging drugs for osteoarthritis; Hunter DJ and Matthews G 16(3): 479–491; 2011 September. 4. Neogi T. (2013). The epidemiology and impact of pain in osteoarthritis.Osteoarthritis and cartilage,21(9), 1145-53. Phase 2b Knee OA Clinical Trial Design Strategy 5 Results Presentation December 2018 §Paradigm Clinical team –extensive clinical trial experience with pain as a primary endpoint. §Ultimate objective of clinical development: To succeed in Phase 3 for successful marketing registration in Australia and abroad. §Previous clinical trial design experience allows Paradigm to identify pitfalls in conducting pain studies and the potential for clinically and statistically significant placebo effect in the clinical trial setting. Strategic Underpinning of Clinical Trial Design §To evaluate the effectiveness of injectable Pentosan Polysulfate Sodium (iPPS) on pain compared with baseline (clinical and statistical significance) in the controlled clinical trial settingieconfirm Therapeutic Goods Association Special Access Scheme (TGA SAS) data. §Toevaluatetheoptimaldesignforphase3clinicaltrial,including: -Targetpopulation:NumericRatingScore(NRS)stratagroups,4-6(moderate pain)and7-8(highpain) -Clinicalmeasurementsbestabletodemonstratestatisticallysignificantand clinicallymeaningfulbenefitsoverplacebo Phase 2b Knee OA –Clinical Trial Design 6 Results Presentation Trial Design Phase2b,randomiseddoubleblindplacebocontrolledmulticentrestudy Primary Endpoint ChangeinKneeinjuryandOsteoarthritisOutcomeScore(KOOS)(Pain Subscale)frombaselinetoDay53 Secondary Endpoints Safety,KOOSPain,KOOSSymptom,KOOSFunction,KOOSQualityofLife, BMELVolume,PatientGlobalImpressionofChange(PGIC) No. Participants 112completedstudyprotocol Active : Placebo Firststratifiedbybaselinepainscore: NRS4-6(moderatepain) NRS7-8(highpain) Thenrandomised1:1iPPS:Placebo Dosing 2mg/kgPentosanPolysulfateSodium(100mg/mlinjectablesolution), administeredbysubcutaneousinjection,twiceweeklyfor6weeks. Placebo Saline(0.9%salinesolution) Recruitment Sites 6sitesthroughoutAustralia(VIC,SA,WAandQLD) December 2018 The Phase 2b, placebo controlled clinical trial was conducted to evaluate the effects of injectable Pentosan Polysulfate sodium (iPPS) on the treatment of pain in subjects with osteoarthritis of the knee and concurrent subchondral bone marrow edema lesions Phase 2b Knee OA –Subject Population Baseline Statistics of Placebo and Treatment Arms Per Protocol Population iPPS Placebo Age,yrs(mean,(min,max)) 57.1(40, 74) 57.6(40, 75) Sex (M:F) M 36:F 19 M 38: F 19 Total (n) 55 57 NRS Pain Strata 4-6 (n) 39 40 NRS Pain Strata 7-8 (n) 16 17 Results Presentation December 2018 Key Inclusion Criteria §Subjects with a clinical diagnosis of osteoarthritis in one or both knees and a radiographic diagnosis of knee osteoarthritis showing a Kellgren-Lawrence score 2, 3 or 4 (i.e. moderate to severe Knee OA), andbaseline pain score of NRS 4-8 inclusive (stratified 4-6, 7-8) §Symptomatic pain for at least 6 months §Males and females aged 40 to 75 years §Body Mass Index (BMI) of 18 to 35.0 kg/m2 §Presence of subchondral bone marrow lesions as determined by MRI 7 Key outcomes from Osteoarthritis Clinical Trials The main goals of clinicians, patients and regulatory authorities of a phase 2 clinical trial for OA §Safety §Clinicallymeaningfulreductioninpain>50%andstatisticalsignificanceover placebo §Lookingforothersignsofmeaningfulclinicalimprovementssuchaspatient wellbeing,qualityoflifeandkneefunction §InformPhase3trialdesign Results Presentation December 20188 Top Line Report: Primary End point at Day 53 § PrimaryEndpointof“ChangeinKOOSpainfrombaseline”met,withstatistical andclinicalsignificancecomparedwithBaseline § DistributionofsubjectsintheNRSstratumof4-6was70%andsubjectsinthe NRSstratumof7-8was30%ofthetotalstudypopulation § NRSstratification4-6:ChangeinKOOSPainscorefrombaselinetoDay53 reachedstatisticalsignificancecomparedwithplaceboatday39and53(referto graphonpage10) § ThesecondaryEndpointofthePatientGlobalImpressionofChange(PGIC)from baselinetoDay53betweeniPPStreatmentandPlacebowasstatistically significantatp=0.0062 Results Presentation December 20189 iPPSTreatment Meets its Primary End Point 0 10 20 30 40 50 60Percentage of Subjects P<0.026 §iPPS treatment is statistically significant compared to placebo (Chi-square analysis) §iPPS treatment showed a clinically meaningful response to pain Placebo iPPS >50% Reduction from Baseline in pain as measured in KOOS Pain Score at Day 53(NRS: 4-6 stratum) Results Presentation December 201810 KOOS Pain Subscale –Clinically Meaningful Pain Reduction of >50% from Baseline §Statistically greater proportions of subjects with >50% reduction in pain from Baseline after iPPSas measured by KOOS Pain subscale (Chi-square analysis) §> 50% pain reduction corresponds to high reduction in pain (OARSI definition) P<0.026 Treatment period P<0.021 Results Presentation December 201811 KOOS Pain Subscale –NRS Stratification: 4-6 NRS Pain Score –Clinically Meaningful Pain Reduction of >50% from Baseline §Statistically greater proportions of subjects with >50% reduction in pain from Baseline after iPPSas measured by NRS pain score (Chi-square analysis) §> 50% pain reduction corresponds to high reduction in pain (OARSI definition) Results Presentation December 201812 P<0.0008 P<0.02 Treatment period NRS Pain Score –NRS Stratification: 4-6 Phase 2b OA Results –Conclusions §Clinicaltrialmettheprimaryendpoint-ChangeinKOOSpainscorefrombaseline atDay53 §ClinicallymeaningfulandstatisticallysignificantresultsbetweeniPPSandPlacebo inthetotalpopulation(p=0.031)andhighlyclinicallymeaningfulandhighly statisticallysignificantintheNRSpain=4-6strata §46.2%ofsubjectsreceivingiPPSshowedagreaterthan50%reductioninpain frombaselinecomparedto22.5%ofsubjectsreceivingPlacebo.Thisisstatistically significantatp=0.026andclinicallymeaningfuli.e.painreductionof50%ormore §DataareconsistentwithTGA-SASwithanaverageof51.4%reductionofpainfrom baselinewithNRSscoresreducedfrom6.3to3.1 §Safetyprofileconfirmed–ExpectedAE’smild/moderateseveritywithnolife threateningAE’s. §ConfirmedtargetpopulationforthePhase3clinicaltrial Results Presentation December 201813 §AsaresultofParadigm'sPhase2bresults,ParadigmintendstofileaNDA(with USAFDA)forapivotalPhase3inCY2019 §TodayParadigmreportedprimaryendpointdataandsecondaryendpointswillbe reportedoninQ1CY2019 §OutstandingPhase2bresultsarelikelytoreachhighereffectandstatistical significanceinlargerPhase3clinicaltrial §NRS=4-6stratadataveryconsistentwithTGASASdata Phase 2b Knee OA Results Key Outcome Inthetotalstudypopulation,iPPSachievedasafe,welltolerated,clinically meaningful,statisticallysignificantresultoverplaceboasdemonstratedbyhigher numberofsubjectswith>50%reductioninKOOSpainscorefrombaseline. NRSstrata4-6,producedhighlyclinicalandstatisticallysignificantresultsover placeboandisthetargetpopulationinourPhase3clinicaltrial. Results Presentation December 201814 2019 Objectives and Catalysts 15 üFileINDforPhase3trialinOA/BMELwiththepossibilityofbeinggranted “fasttrackstatus”forthePhase3trial üRossRiverPhase2atrialresultsrelease–Q1CY2019 üCY2019fileINDforrecentlyin-licensedMPSindication üDosefirstCompassionateUseOApatientintheUS üRecruitUSbasedmedicalandclin/regstaff üPossibilityofearlyrevenuein2019viareceiving‘ProvisionalApproval’from TGAtosellZilosul(iPPS) üOngoingreleaseofadditionalTGAspecialaccessschemeresults–Potential fornewjointsand/orneworthopaedicindications üUpcomingreleaseofpeerreviewscientificpaper/sinconjunctionwithPhase 2bsecondaryend-pointdata üDiscussionswithbigpharma Results Presentation December 2018 Paradigm is well positioned to execute many valuable milestones throughout CY19 Contacts 16 Office Level 2,517 Flinders Lane, Melbourne, VIC, 3000 [email protected] CORPORATE ENQUIRIES: Managing Director & CEO Paul Rennie [email protected] INVESTOR RELATIONS: Dirk van Dissel-Adelaide Equity Partners Ltd E: [email protected]: +61 408 326 367 Alastair Murray -Adelaide Equity Partners Ltd E: [email protected]: +61 415 629 977 Results Presentation December 2018

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