OPAL TECHNOLOGYAddressing market need for next-generation antimicrobials

Opal Biosciences Limited is an

innovative player in infectious

disease treatment. An Australian

biotechnology company committed to

tackling a serious global health threat.

ThemainassetofOpalBiosciencesLimited(“Opal”)isasmallmoleculethathasdemonstratedactivityagainstsomeofthehighestthreatgermstohumans.

OpalTechnology’spotentialtosuccessfullytreatamultitudeofinfectionsviaanarrayofapplicationsincludinginjections,eyedrops,creamsandtablets,suggeststhisscientificdiscoveryisavaluableone.

Withanexperiencedinternationalteamalreadyinplace,thefollowingproductdevelopmentisunderway.

• Opal-I,aninjectableproduct,and• Opal-T,whichcanbeappliedtoskin.

Introducing Opal Technology

OpalBiosciencesLimitedACN:605631963Level4,100AlbertRoad,SouthMelbourneVictoria3205Australia

Investment Potential

ANTIMICROBIAL

Thisprojectbringstogetherawealthofinternationalexpertise.ExplorationofthepotentialvalueofOpalTechnologyasaviableinfectiousdiseasetreatment-conductedatvariousresearchinstitutionsinAustraliaandtheUnitedStates,including:

• GriffithUniversity• UniversityofWesternSydney• SydneyUniversity• RMITUniversity• QueenslandInstituteofMedical

Research(QIMR)• U.S.ArmyMedicalResearch

InstituteofInfectiousDiseases(USAMRIID)

• U.S.NationalInstituteofAllergyandInfectiousDiseases(NIAID)1

1http://www.niaid.nih.gov/LabsAndResources/resources/dmid/invitro/Pages/invitro.aspxhttp://www.niaid.nih.gov/labsandresources/resources/dmid/animalmodels/Pages/default.aspx

THE TEAMOpal’smanagementteamisexperiencedinallphasesofpharmaceuticalproductdevelopment.

The management team includes:HughMMorganAC,ChairmanProfessorLarisaRudenko,Non Executive DirectorJuliePhillips,Managing DirectorMelanieLeydin,Company Secretary and Chief Financial OfficerCathyCropp,Project Manager

Commercial interest has already been expressed in Opal Technology pending the collection of specific data.

Opalisseekinganequityfundinginvestmenttodevelopitsproducts,Opal-IandOpal-T.Itscommercialobjectiveistoout-licenseorsellthetechnologiestoalargerpharmaceuticalcompanyforclinicaltrialsandmarketing.

ThisisauniqueopportunityforsophisticatedinvestorstogainastakeintheOpalTechnologyprojectatapivotaltime,withkeyresearchmilestonesexpectedtobereachedwithin2to3years.

Taking Opal Technology To The Next Stage

Global Collaborations

Effective new treatments to combat dangerous “superbugs” and antibiotic resistant bacteria and fungi could be on the near horizon, thanks to Opal Technology.

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Growing market:Duetoantibioticresistanceacrosstheglobethereisanurgentneedfornewtreatmentsforinfections.Theglobalanti-infectivesmarketiscurrentlyvaluedatUS$103billionandgrowing.

Few competitors:Thereareveryfewanti-infectivedrugsinthedevelopmentpipeline.

Government incentives: BoththeEUandUShaveintroducedincentivestohelpfacilitatethedevelopmentofanti-infectivedrugs;reducingriskandcostsformanufacturers.

Major pharmas returning to the sector: Theprevalenceofantibioticresistantgermshasspurredmultinationalpharmaceuticalcompaniestoreturntotheanti-infectivessector,andbuyupinnovationalongtheway.

Opal Technology’s potential: Activitydemonstratedagainstmanyseriouslifethreateninghumanmicrobesinthelaboratory(invitro).Basedontheseencouragingstudies,acleardevelopmentplanisinplace,whichinvolvespartnershipswithprominentinternationalresearchinstitutions.

Marketsizesref:GlobalAntifungalTherapeuticsMarket:TrendsandOpportunities(2014-2019)DaedalResearch,August2014;Anti-infectives–AGlobalStrategicBusinessReport,GlobalIndustryAnalysts,Inc.MCP-6156,February,2010.;AntibacterialDrugsMarket–AGlobalIndustryAnalysis,Size,Share,Growth,trendsandForecast,2013-2019,TransparencyMarketResearch,March2014

Risingantibioticresistanceisaseriousglobalhealththreatwithgovernmentsaroundtheworldrecognisingthereisanurgentneedfornewtreatments.Reasonsforgrowingconcerninclude:

• Increasing resistance seen to existing antibiotics. Thisisgivingriseto“superbugs”whicharenotasresponsiveorcompletelyresistanttocurrenttreatments.

• Infections that were rare are becoming common,suchasmulti-drugresistantstrainsofMRSA,commonlyknownasGoldenStaph.

• Patientswithreducedimmunityarelivinglonger(e.g.followingcancertreatment,therapyforHIV),andhighly susceptible to contracting infections.

• There are not enough new drugs in development.In2014,thePewtrustreported,“therearetoofewdrugsindevelopmenttomeetcurrentandanticipatedpatient’sneeds3”.

Thereforethesceneissetforthediscoveryanddevelopmentofnewanti-infectivetreatments.

2http://www.cdc.gov/drugresistance/threat-report-2013/3http://www.pewtrusts.org/en/research-and-analysis/issue-briefs/2014/03/12/tracking-the-pipeline-of-antibiotics-in-development

OPAL - I

OPAL - T

Product formulation

Product formulation

Skin penetration studies and stability testing

Opal-T manufacture

Tolerability studies Pharmaco

Kinetics Opal-I manufacture

July 2015 Jan - Jun 2017

Animal efficacy studies

Completionofanimalstudiesfor

Opal-I

CompletionofOpal-T-Final

Product

Opal Technology Development Plan (Indicative)

The Infectious Diseases Market - What You Need To Know

23,000 people die yearly from antibiotic resistant bacterial infections in

the U.S. and more than 2 million fall ill, according to the

Centers for Disease Control.2

Global antifungals

market, US$13.9 billion

Global antibacterials

market, US$45 billion

by 2019

Global anti-infectives

market, US$103 billion

by 2015

OpalBiosciencesLimitedACN:605631963Level4,100AlbertRoad,SouthMelbourneVictoria3205Australia

ANTIMICROBIAL

• Synthesis/batchmanufactureto“GLP”standardswithstabilityofdrugsubstanceupto3years;

• AntimicrobialscreeningconductedundercontracttoRMITUniversity,NIAID,USAMRIID,MonashUniversity,QIMR&UniversityofSydney;

• Mechanismofaction&resistancestudies:RMITUniversity,UniversityofWesternSydney,GriffithUniversity;Invivopilotwork:USAMRIID,NIAID,QIMR;

• Physicochemicalprofiling/preliminarydrugformulationstudiesforiv&oraladministration;Pharmacokinetics:clearancestudies,serumassaydevelopment,studiesinrat,mouse(oral,iv&ipadministration);

• PreliminaryToxicology:non-GLPstudiesinrat,nudemouse;GLPsingledosepoandivinrat,repeatdoseinrat;oneGLPgenetictoxicologystudy.

For further information please contact:Julie Phillips – Managing DirectorTel: + 61 3 9692 7240Email: jphillips@opalbiosciences.com

Work Already Undertaken• LoK,CornellH,NicolettiG,

JacksonN,andHugelH.AStudyofFluorinatedbeta-NitrostyrenesasAntimicrobialAgents,.Appl.Sci.2012,2,114-128.

• WhiteKS,NicolettiGandBorlandR,NitropropenylBenzodioxole,AnAnti-infectiveAgentwithActionasaProteinTyrosinePhosphateInhibitor,TheOpenMedicinalChemistryJournal.2014,8,1-6.

• WhiteKS,Theantimicrobialmechanismofactionof3,4-methylenedioxy-b-nitropropene,PhDthesis,RMIT,2009.

• CornellH,NguyenT,NicolettiG,JacksonN,andHugelH.ComparisonofHalogenatedbeta-NitrostyrenesasAntimicrobialAgents,.Appl.Sci.2014,4,380-389.

Growing concern about antibiotic resistance:Earlyin2014theWHOReport“AntimicrobialResistance:GlobalReportonSurveillance”wasreleased.Initsopeningpagesitstates:

“Antimicrobial resistance (AMR) within a wide range of infectious agents is a growing public health threat of broad concern to countries and multiple sectors. Increasingly, governments around the world are beginning to pay attention to a problem so serious that it threatens the achievements of modern medicine. A post-antibiotic era—in which common infections and minor injuries can kill—far from being an apocalyptic fantasy, is instead a very real possibility for the 21st century4.”

4http://www.who.int/drugresistance/documents/surveillancereport/en/

Disease Targets

Publications

DiseasescoveredbyOpalTechnology’scollectivepatents:

• Varietyofbacterialinfections

• Fungalinfections

• Sexuallytransmittedinfections

• Malaria

• MRSA(ahighprofilestrainof“GoldenStaph”)

• Tuberculosis

OpalTechnology-screenedasapotentialbiologicalweaponscounter-measure.