presentation to investors - biotron limited · presentation to investors i attach a powerpoint...

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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

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Page 1: Presentation to Investors - Biotron Limited · PRESENTATION TO INVESTORS I attach a PowerPoint presentation as presented by Biotron Limited's Managing Director, Dr Michelle Miller,

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

Page 2: Presentation to Investors - Biotron Limited · PRESENTATION TO INVESTORS I attach a PowerPoint presentation as presented by Biotron Limited's Managing Director, Dr Michelle Miller,

BIOTRONLIMITED(ASX:BIT)InvestorUpdateOctober2017

Page 3: Presentation to Investors - Biotron Limited · PRESENTATION TO INVESTORS I attach a PowerPoint presentation as presented by Biotron Limited's Managing Director, Dr Michelle Miller,

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.

Page 4: Presentation to Investors - Biotron Limited · PRESENTATION TO INVESTORS I attach a PowerPoint presentation as presented by Biotron Limited's Managing Director, Dr Michelle Miller,

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

Page 5: Presentation to Investors - Biotron Limited · PRESENTATION TO INVESTORS I attach a PowerPoint presentation as presented by Biotron Limited's Managing Director, Dr Michelle Miller,

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

Page 6: Presentation to Investors - Biotron Limited · PRESENTATION TO INVESTORS I attach a PowerPoint presentation as presented by Biotron Limited's Managing Director, Dr Michelle Miller,

Viroporins

•  Smallhydrophobicproteinswithion

channelac4vity•  Formhydrophilicporesinhostcell

membranes•  Keystagesoftheviralcyclesuchas

virusuncoa4ng,transportandmatura4onareion-influencedprocessesinmanyviralspecies

•  Crucialforviralpathogenicityduetoinvolvementinvariousstepsofviruslifecycles

•  Idealtherapeu4ctargets

NatureReviewsMicrobiology10,563-574

Page 7: Presentation to Investors - Biotron Limited · PRESENTATION TO INVESTORS I attach a PowerPoint presentation as presented by Biotron Limited's Managing Director, Dr Michelle Miller,

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)

Page 8: Presentation to Investors - Biotron Limited · PRESENTATION TO INVESTORS I attach a PowerPoint presentation as presented by Biotron Limited's Managing Director, Dr Michelle Miller,

•  BIT225inhibitsassemblyandbuddingofnewvirusinmacrophagereservoirs

•  Phase1b/2atrial(004)demonstratedthatBIT225canreduceHIV-1levelsinmacrophagecellsinvivo,parallelinginvitrostudies(Wilkinsonetal,JAn4microbChemother.2015)

•  Phase2trial(009)iscurrentlyinprogresstodemonstrateaclinicalbenefitoverandabovecurrentanE-HIVdrugs

BIT225TargetsHIV-1inVirusReservoirs

A B

(A)UntreatedControls (B)BIT225treatedcells

Page 9: Presentation to Investors - Biotron Limited · PRESENTATION TO INVESTORS I attach a PowerPoint presentation as presented by Biotron Limited's Managing Director, Dr Michelle Miller,

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

Page 10: Presentation to Investors - Biotron Limited · PRESENTATION TO INVESTORS I attach a PowerPoint presentation as presented by Biotron Limited's Managing Director, Dr Michelle Miller,

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

Page 11: Presentation to Investors - Biotron Limited · PRESENTATION TO INVESTORS I attach a PowerPoint presentation as presented by Biotron Limited's Managing Director, Dr Michelle Miller,

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

Page 12: Presentation to Investors - Biotron Limited · PRESENTATION TO INVESTORS I attach a PowerPoint presentation as presented by Biotron Limited's Managing Director, Dr Michelle Miller,

UnlockingValueinCompoundLibrary

•  Renewedindustryinterestintarge4ngviraldiseasesincluding

•  Respiratorydiseasese.g.Respiratorysyncy4alvirus(RSV)&Influenza

•  Hepa44sBvirus

•  TropicaldiseasesincludingDengue

•  Influenza,Ebola,ZikaandMERS-CoVoutbreakshavecausedpublichealthissuesworldwide

•  BIT225hasdemonstratedtherobustnessofBiotron’sapproachwithtargeEngviroporinproteins

•  Compoundswithac4vityagainstotherkeyviruseshavebeeniden4fied;secondaryscreeningisinprogress,withtheaimofiden4fyingpoten4alclinicalcandidates

•  MainfocusremainsoncommercialisingtheCompany’sHIV-1andHCVprograms,butessen4althatotheropportuni4esaredeveloped

Page 13: Presentation to Investors - Biotron Limited · PRESENTATION TO INVESTORS I attach a PowerPoint presentation as presented by Biotron Limited's Managing Director, Dr Michelle Miller,

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

Page 14: Presentation to Investors - Biotron Limited · PRESENTATION TO INVESTORS I attach a PowerPoint presentation as presented by Biotron Limited's Managing Director, Dr Michelle Miller,

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

Page 15: Presentation to Investors - Biotron Limited · PRESENTATION TO INVESTORS I attach a PowerPoint presentation as presented by Biotron Limited's Managing Director, Dr Michelle Miller,

15 20

REPORT ANNUAL

BIOTRON

41

DrMichelleMillerManagingDirector+61412313329mmiller@biotron.com.auwww.biotron.com.au