slide ’tle - biotron

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Page 1: Slide ’tle - Biotron

Slide'tle

Page 2: Slide ’tle - Biotron

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.

Page 3: Slide ’tle - Biotron

InvestmentHighlights

•  Biotronisdesigning,developingandcommercialisingaplaUormofan'viraldrugswithanovelmodeofac'on–abletotargetawidevarietyofviralinfec'ons

•  Pipelineofprogramsinhighvalue,highneedmarkets•  Progressinclinicalleadprogram(BIT225)providesstrongvalida'onforen'replaUorm

Page 4: Slide ’tle - Biotron

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

Page 5: Slide ’tle - Biotron

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)

Page 6: Slide ’tle - Biotron

CommercialisaUon–KeyFocus

•  Threetac'calpriori'es:•  Partneringleadclinicalprogram-BIT225forHIV-1eradica'on

•  Partneringoneormorepreclinicalprograms–e.g.HBV

•  ExecutearegionallicensingdealinChina-HCVprogramremainsagreatopportunity

Page 7: Slide ’tle - Biotron

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

Page 8: Slide ’tle - Biotron

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)

Page 9: Slide ’tle - Biotron

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

Page 10: Slide ’tle - Biotron

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

Page 11: Slide ’tle - Biotron

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

Page 12: Slide ’tle - Biotron

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

Page 13: Slide ’tle - Biotron

•  Seekingpartnershipsforcommercialisa'onofBIT225forthetreatmentofHCVinChina

•  AppointedaShanghai-basedcorporateadvisorwithextensiveexperienceincross-border

transac'onsinthehealthcarespace

•  Developedawellqualifiedprospectlist

•  Presentedtopoten'allicensees–allwithcapacitytofinalisecommercialdevelopmentand

launchofBIT225inChina

•  Discussionsareon-going

CommercialisaUon:RegionalLicensing–China,HCVProgram

Page 14: Slide ’tle - Biotron

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

Page 15: Slide ’tle - Biotron

UnlockingValueforOtherVirusTargetsBiotron’sViroporinapproachenablesthetarge'ngofawiderangeofviraldiseases;examplesinclude:•  RespiratoryVirusessuchasRespiratorySyncy'alVirus(RSV),Influenza,&Coronaviruses(leadingcauseof

“commoncold”)•  FlavivirusessuchasZikaVirusandDengue•  TransplantvirusessuchasBKvirus•  EpsteinBarrvirus(EBV)-par'cularinterestinAsiawhereitiscausa'veagentofNasopharyngeal

Carcinoma

Biotron’sViroporinplacormhasthepotenUaltobecomeanimportanttoolinthe

developmentofanUviraltherapies

PotenUalforestablishingearlystagecollaboraUonswithpharmaceuUcalcompaniesuUlisingBiotron’sapproach

Page 16: Slide ’tle - Biotron

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