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Level 2, 66 Hunter Street
Sydney NSW 2000
Tel: (61-2) 9300 3344
Fax: (61-2) 9221 6333
E-mail: [email protected]
Website: www.biotron.com.au
6 October 2017
The Manager Companies
ASX Limited
20 Bridge Street
Sydney NSW 2000 (15 pages by email)
Dear Madam
PRESENTATION TO INVESTORS
I attach a PowerPoint presentation as presented by Biotron Limited's Managing Director, Dr Michelle
Miller, to investors.
Yours sincerely
Peter J. Nightingale
Company Secretary
pjn9101
BIOTRONLIMITED(ASX:BIT)InvestorUpdateOctober2017
Forward Looking Statements
Thispresenta4onmaycontainforward-lookingstatementswithrespecttothefinancialcondi4on,resultsandbusinessachievements/performanceofBiotronLimited(ACN086399144)andcertainof the plans and objec4ves of its management. These statements are statements that are nothistoricalfacts.Wordssuchas“should”,“expects”,“an4cipates”,“es4mates”,“believes”orsimilarexpressions,astheyrelatetoBiotronLimited,areintendedtoiden4fyforward-lookingstatements.By their nature, forward-looking statements involve risk and uncertainty because they reflectBiotron’scurrentexpecta4onsandassump4onsastofutureeventsandcircumstancesthatmaynotprove accurate. There is no guarantee that the expected events, trends or results will actuallyoccur. Any changes in such assump4ons or expecta4ons could cause actual results to differmateriallyfromcurrentexpecta4ons.
BiotronLimited-InvestmentHighlights
• Infec4ousdiseasefocus
• Phase2clinicalprogram-HIV-1eradica4ontrialdataexpected4Q17
• Pipelineofearlierstagean4-viralprogramsincludingrespiratoryviruses,
Denguevirus,hepa44sBvirusandothers
• Severalnearterm,value-addingmilestonesan4cipatedovernextfewmonths
• SpunoutfromJohnCur4nSchoolofMedicalResearchattheAustralianNa4onalUniversity
• ListedonASX(ASX:BIT)
• HeadquarteredinSydney,Australia
BoardMichaelHoy Non-execu4veChairman
MichelleMiller ManagingDirector
SusanPond Non-execu4veDirector
RobThomas Non-execu4veDirector
DenisWade Non-execu4veDirector
Biotron–LeaderinAnEviralDrugDevelopment
• Exper4seisthedevelopmentofanewclassofan4viraldrugstarge4ngviral-encodedviroporinproteins
• Viroporinsarepresentinbroadrangeofviruses:Influenza(M2),HIV-1(Vpu),HCV(p7),DengueandWestNile(Mprotein),SARS(Eprotein)andothers
• Broadplaiorm:
• Rapid,proprietaryprimarybacterialcell-basedscreeningassaysfortargetproteins
• Focusedlibraryofcompoundsthattargettheseviralproteins
• Pipelineofinternally-generated,first-in-classsmallmoleculeviroporininhibitorsforkeymarkets
Viroporins
• Smallhydrophobicproteinswithion
channelac4vity• Formhydrophilicporesinhostcell
membranes• Keystagesoftheviralcyclesuchas
virusuncoa4ng,transportandmatura4onareion-influencedprocessesinmanyviralspecies
• Crucialforviralpathogenicityduetoinvolvementinvariousstepsofviruslifecycles
• Idealtherapeu4ctargets
NatureReviewsMicrobiology10,563-574
HIV-1EradicaEon
CurrentdrugsdonoteradicateHIV-1virus• HIV-1remainshiddeninreservoirs,leadingto
chronic,life-longinfec4on– Invisibletobody’simmunedefenses
– Notsensi4vetoan4-HIV-1drugs• Newmodeofac4onsdrugsareneededtoeradicate
orcureHIV-1infec4onWhyisHIV-1eradicaEonnecessary?
• Long-termhealthimplica4onse.g.HAND,immuneac4va4on,etc
• Costoftreatment– ~$20billionp.a.worldwide
– Majorburdenonhealthcaresystems
MarioStevensonScien6ficAmerican299,78-83(2008)
• BIT225inhibitsassemblyandbuddingofnewvirusinmacrophagereservoirs
• Phase1b/2atrial(004)demonstratedthatBIT225canreduceHIV-1levelsinmacrophagecellsinvivo,parallelinginvitrostudies(Wilkinsonetal,JAn4microbChemother.2015)
• Phase2trial(009)iscurrentlyinprogresstodemonstrateaclinicalbenefitoverandabovecurrentanE-HIVdrugs
BIT225TargetsHIV-1inVirusReservoirs
A B
(A)UntreatedControls (B)BIT225treatedcells
Phase 2 Trial – BIT225-009 In Progress
• 36HIV-1+ve,treatment-naïvesubjectscommencingART• Randomised2:1(drug:placebo)• BIT225orplaceboaddedtoARTforfirst12weeksoftreatment• Read-out
• Impactonviralloadkine4cs;reduc4onofimmuneac4va4onmarkers• Trialsites–HIV-NAT,Bangkok,andChiangMai,Thailand• Fullyrecruited;preliminarydataanEcipatedNov‘17
BIT225orplaceboaddedtoART
x xxxx x x
BIT225–FirstofaNewClassofHCVDAADrugs
• TargetsHCVp7protein-Inhibitsviralassemblyandinfec4vity
• Pan-genotypeac4vity:
• Ac4veinvitroagainstallmaingenotypes
• Clinicalac4vityagainstHCVGT1(1aand1b)andGT3demonstratedinPhase2atrials
• Seekingpartnershipsforfurtherdevelopment,inpar4cular,inAsia
• EmergingevidencethatInterferonsparingtherapiesmaycausereac4va4onofHepa44sB(HBV)
• Riskofreac4va4onofHBVhasresultedin‘blackbox’warningsbytheUSAFDAontherecentlyapprovedHCVdrugs
• 30–50millionHCV-infectedsubjectsinChina
• HighHCV/HBVco-infec4onrateinChina
• Alterna4vetreatmentstrategiesmayberequiredfortrea4ngdifferentpa4entpopula4onsacrossemergingmarketssuchasChina;BIT225wellposi4onedfortreatmentofHCVinthesepopula4ons
Core Technology Drives Rich Compound Library
Libraryofcompoundsdesignedtotargetviroporins:Ini4ally>250compoundsdesignedandsynthesised;librarynow~350OTHER“HITS”INLIBRARYinclude:• InfluenzaAandB• Hepa44sBvirus(HBV)• Coronaviruses(Including
SARS)• Epstein-Barrvirus(EBV)• Zikavirus• others
X-axis:compoundIDY-axis:virusZ-axis:strengthofhit
UnlockingValueinCompoundLibrary
• Renewedindustryinterestintarge4ngviraldiseasesincluding
• Respiratorydiseasese.g.Respiratorysyncy4alvirus(RSV)&Influenza
• Hepa44sBvirus
• TropicaldiseasesincludingDengue
• Influenza,Ebola,ZikaandMERS-CoVoutbreakshavecausedpublichealthissuesworldwide
• BIT225hasdemonstratedtherobustnessofBiotron’sapproachwithtargeEngviroporinproteins
• Compoundswithac4vityagainstotherkeyviruseshavebeeniden4fied;secondaryscreeningisinprogress,withtheaimofiden4fyingpoten4alclinicalcandidates
• MainfocusremainsoncommercialisingtheCompany’sHIV-1andHCVprograms,butessen4althatotheropportuni4esaredeveloped
CommercialisaEon:MulEplePartneringOpportuniEes
CommercialacEviEesfocusedonfindingpartnersforindividualtargetsorenErepla`orm
• HIV-1Program
• Significantvalueinflec4onexpectedinlate2017onbasisofPhase2data
• AimtopartneratconclusionofcurrentPhase2trial
• HCVProgram
• BIT225par4cularlywellsuitedtoAsia,withhighnumbersofHCV-infectedpa4entsincludingahighpropor4onofHCV/HBVco-infectedpa4ents
• FocusedonachievingaregionaldealforHCVinChinainlate2017/early2018
• Earlystagecollabora4onopportuni4esforpre-clinicaltargets,suchas:• Dengue• Hepa44sB• Influenza
• Addi4onaldevelopmentcollabora4onpoten4alfor“other”pharmatargets
InvestmentHighlights
Por`olioofpatentsandpatentapplicaEonsdirected to theCompany’s anE-viraldrugpor`olio
STRONGINTELLECTUALPROPERTYPOSITION
TargeEngviroporinproteinswitharapidscreeningproprietaryprimarybacterialcell-basedpla`orm-alibraryofover350compoundswithacEvityagainstarangeofviruses.
NOVELANTIVIRALPLATFORM
ClinicalandPreclinicalprogramsinindicaEonswithhighunmetclinicalneedorlargepaEentpopulaEonssuchasHIV-1,HCV,Dengue,HBV,respiratoryviruses,etc
BROADANTIVIRALPIPELINE
Completed7humanClinicalTrialswithpromisingsafetyandefficacyoutcomes;KEYPHASE2HIV-1TRIALDATAEXPECTED4Q17
ROBUSTCLINICALVALIDATION
15 20
REPORT ANNUAL
BIOTRON
41
DrMichelleMillerManagingDirector+61412313329mmiller@biotron.com.auwww.biotron.com.au