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ForwardLookingStatements
Thispresenta'onmaycontainforward lookingstatementswithrespecttothefinancialcondi'on, resultsandbusinessachievements/performanceofBiotronLimited (ACN086399144)andcertainof theplansandobjec'vesofitsmanagement.Thesestatementsarestatementsthatarenot historicalfacts.Wordssuchas“should”,“expects”,“an'cipates”,“es'mates”,“believes”orsimilar expressions,astheyrelateto Biotron Limited, are intended to iden'fy forward lookingstatements. By their nature, forward lookingstatements involve risk and uncertainty because they reflect Biotron’s current expecta'ons andassump'onsastofutureeventsandcircumstancesthatmaynot proveaccurate.Thereisnoguaranteethat the expected events, trends or results will actually occur. Any changes in such assump'ons orexpecta'onscouldcauseactualresultstodiffermateriallyfromcurrentexpecta'ons.
InvestmentHighlights
• Biotronisdesigning,developingandcommercialisingaplaUormofan'viraldrugswithanovelmodeofac'on–abletotargetawidevarietyofviralinfec'ons
• Pipelineofprogramsinhighvalue,highneedmarkets• Progressinclinicalleadprogram(BIT225)providesstrongvalida'onforen'replaUorm
BiotronLimited–SnapShot
BROADPLATFORMWITHNEWCLASSOFANTIVIRALDRUGS
HIV-1ERADICATION HBV&EARLYSTAGEPROGRAMSHEPATITISCVIRUS(HCV)
- Targe'ngHIV-1inlong-livedreservoirs
- Phase2trialinprogressduring2017;dosingcomplete
- NewclassofHCVdrug
- Phase2completed
- SeekingpartnershipsinChina
- Pipelineofearlystageprograms,including:
- Hepa''sBvirus
- Respiratoryviruses
- Flaviviruses(e.g.Dengue)
ROBUSTCLINICALVALIDATION–COMPLETED8CLINICALTRIALSWITH
STRONGSAFETY&EFFICACYOUTCOMES
KeyAchievementsFY2017
• CommencedPhase2clinicaltrialofBIT225andCombina'onAn'retroviralTherapy(cART)inFeb’17
• FullyrecruitedinJuly‘17;DosingwithBIT225/placebocompleted;datapending
• Demonstratedsignificantandacceleratedreduc'oninHIV-1viralloadfollowingaddi'onofBIT225inhumanisedmousestudyinFeb‘17
• IndependentNaturepublica'onvalidatedBiotron’sapproachoftarge'ngHIV-1inmacrophagesasakeystepinHIV-1eradica'oninMay’17
• AppointedLynxFinancialasCorporateAdvisorforChina–assis'ngwithexecu'ngHCVregionalpartneringstrategyinJune‘17
• Raised$1.56millionviarightsissueinJune‘17
• Received$1.6millionR&DtaxrefundinNov‘17(post-endofFY)
CommercialisaUon–KeyFocus
• Threetac'calpriori'es:• Partneringleadclinicalprogram-BIT225forHIV-1eradica'on
• Partneringoneormorepreclinicalprograms–e.g.HBV
• ExecutearegionallicensingdealinChina-HCVprogramremainsagreatopportunity
HIV-1EradicaUon
MarioStevensonScien.ficAmerican299,78-83(2008)
CurrentdrugsdonoteradicateHIV-1virus
WhyisHIV-1eradicaUonnecessary?• Long-termhealthimplica'onse.g.HAND,immuneac'va'on,etc• Costoftreatment
• ~$20billionp.a.worldwide• Majorburdenonhealthcaresystems
BIT225haspotenUaltobeusedincombinaUonwithotherdrugsto
eradicateHIV-1reservoirs
• HIV-1remainshiddeninreservoirs,leadingtochronic,life-longinfec'on• Invisibletobody’simmunedefenses• Notsensi'vetoan'-HIV-1drugs
• Newmodeofac'onsdrugsareneededtoeradicateorcureHIV-1infec'on
HIV-1EradicaUon:BIT225-009Trial
• 36HIV-1+ve,treatment-naïvesubjectscommencingART• Randomised2:1(drug:placebo)
BIT225orplaceboaddedtoART
• BIT225orplaceboaddedtoARTforfirst12weeksoftreatment• Read-out
• Impactonviruslevels;reduc'onofimmuneac'va'onmarkers• Fullyrecruited;completeddosingwithBIT225/placebo;infollow-upperiod(ARTalone)
HIV-1EradicaUon:BIT225-009Trial
• FullyrecruitedJuly;lastpa'ent,lastdoseinmid-October
• Threemonthfollow-upperiodpost-dosingwithBIT225/placebo
• Addi'onalsamplescollectedfrompa'entsthroughoutthisnext3monthperiod
• Post-triallaboratoryanalysesonsamplesfromtreatmentperiodareinprogress:
• VirologicalOutcomes
• ImmunologicalOutcomes
• Post-dosingsampledataalsorequiredtocompletetheanalyses
• E.g.Anyreboundorchangeinparametersoncedrugceased?
• Alldataisnecessarytodetermineoutcomeofthetrial
CommercialisaUon:BIT225HIV-1EradicaUon
• Severalpharmaceu'calcompanieshaveac'veHIV-1“Cure”Programs• Iden'fiedandqualifiedpoten'alpartners
• Posi'veoutcomes–BIT225clinicaltrial-keytoprogressingcommercialisa'ondiscussions
• Poten'alpartnershavedefinedtheirsuccesscriteria–wearealigned!
• Communica'ngtrialdataassoonasavailable
• Followupmee'ngswithpoten'alpartnerscon'nue
CommercialisaUon:PreclinicalPrograms–HBV
• Hepa''sBvirus(HBV)therapeu'cspacehassignificantinterestfrompharma&biotechcompanies
• Biotron’sHBVprogramiselici'ngearlyinterestfrompoten'alpartners
• Invitrodataonseveralcandidatecompoundsincludesevidenceofreduc'onofindustryrecognisedmarkers
• Novelmechanismisveryasrac'veincombina'onapproachestotreatmentofHBV
• ExpandsBiotron’spartneringopportuni'es–poten'alforearlystageco-development/collabora'onagreement
CommercialisaUon:RegionalLicensing–China,HCVProgram
• ThenewHCVdrugs(e.g.Solvadi)maycausereac'va'onofHBVinHCV/HBVcoinfectedpa'ents
• ResultedinUSFDA“BlackBox”WarningonnewHCVdrugs
• 30millionHCV-infectedpeopleinChina,comparedto3-5millioninUSA
• 93millionchronicallyinfectedwithHBVinChina,comparedto2.2millioninUSA
• HighHCV/HBVco-infec'onrateinChina(es'matedtobe10million)
• Reac'va'onofHBVinpeopleundergoingHCVtreatmentwiththesenewHCVdrugshaspoten'altobeamajorhealth&economicissueinChina
• BIT225hasbeenshowninclinicaltrialstosignificantlyimproveclinicaloutcomeinHCVGT1-infectedpa'entsincombina'onwithInterferon&Ribavirin(IFN/RBV)
• IFN/RBVhaveseveralpoten'aladvantagesovernewHCVdrugsinsomesevngs
• IFN/RBVissignificantlycheaperthanthenewHCVdrugs
• HBVreac'va'onislesscommonandlesssevereinHCV/HBVco-infectedpa'entswithIFN/RBV
• Seekingpartnershipsforcommercialisa'onofBIT225forthetreatmentofHCVinChina
• AppointedaShanghai-basedcorporateadvisorwithextensiveexperienceincross-border
transac'onsinthehealthcarespace
• Developedawellqualifiedprospectlist
• Presentedtopoten'allicensees–allwithcapacitytofinalisecommercialdevelopmentand
launchofBIT225inChina
• Discussionsareon-going
CommercialisaUon:RegionalLicensing–China,HCVProgram
UnlockingValueforOtherVirusTargets
Libraryofcompoundsdesignedtotargetviroporinsfoundinsomeviruses:Ini'ally>250compoundsdesignedandsynthesised;librarynow~350OTHER“HITS”INLIBRARYinclude:• InfluenzaAandB• Hepa''sBvirus(HBV)• Coronaviruses(IncludingSARS)• Epstein-Barrvirus(EBV)• Zikavirus• others
X-axis:compoundIDY-axis:virusZ-axis:strengthofhit
UnlockingValueforOtherVirusTargetsBiotron’sViroporinapproachenablesthetarge'ngofawiderangeofviraldiseases;examplesinclude:• RespiratoryVirusessuchasRespiratorySyncy'alVirus(RSV),Influenza,&Coronaviruses(leadingcauseof
“commoncold”)• FlavivirusessuchasZikaVirusandDengue• TransplantvirusessuchasBKvirus• EpsteinBarrvirus(EBV)-par'cularinterestinAsiawhereitiscausa'veagentofNasopharyngeal
Carcinoma
Biotron’sViroporinplacormhasthepotenUaltobecomeanimportanttoolinthe
developmentofanUviraltherapies
PotenUalforestablishingearlystagecollaboraUonswithpharmaceuUcalcompaniesuUlisingBiotron’sapproach
Summary
• HIVEradicaUon• Engagedwiththerightpoten'alpartners• Wai'ngfordatafromtrialbutcon'nuetoengagewithpharma
• PreclinicalPrograms• HBVhaspromiseasapreclinicalcandidateforjointdevelopment.HBVtherapeu'cspaceisveryhot.• BIT225resultsvalidatetheplaUorm;poten'altofacilitatefundeddevelopmentsbypartnersfor
“other”viraldiseases• RegionalLicensing
• HCVinChinaremainsasignificantdevelopmentopportunity–“cost-conscious”marketcombinedwiththehighrateofco-infec'onHCV&HBVrequiresdifferentapproachthanusedintheUSA
Successinanyorallofthesestrategieswillbea“companymaker”increasingthevaluefor
Biotronstakeholders