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SalvaRxGroupplc
(“SalvaRx”,“theCompany”or“theGroup”)
FinalResultsChairman’sStatementI ampleased topresent the audited final results for SalvaRx. As a reminder, inMarch2016, SalvaRx Limitedbecameawhollyownedsubsidiaryof3Legsviaareversetakeover(“RTO”),aspartofourplantocreateamulti-productdrugdevelopmentportfoliocompanyfocusedoncancerimmunotherapy.3LegsalsochangeditsnametoSalvaRxGroupplc(“SalvaRx”)andwasre-admittedtotradingontheAlternativeInvestmentMarket(“AIM”)oftheLondonStockExchange(AIM:SALV),on22March2016.Sincethen,theteamhasexecuteduponitsstrategytogrowapipelineofnoveltreatmentsforcancer.Thecancerimmunotherapymarketcontinuestobearapidlygrowingtherapeuticarea.Asoftoday,therearefiveapprovedanti-PD1agentsintheUnitedStates.Thisisthefirsttimeintheoncologyfieldwherefiveofthelargecappharmacompanies(Pfizer,Merck,BMS,AstraZeneca,andRoche)arecompetingwithsimilardrugs.Giventhelackofdifferentiation,eachcompanyisstrivingtocreatenovelcombinationswithsecondagentstocompetewith one another. BMS is in the lead in this areawith their proprietary combination of Opdivo and Yervoy.Collectively,largecappharmacompaniesarerunninghundredsofotherstudieslookingatcombinationsofnewagentswiththeirPD1products.FormerBMSexecutivescreatedSalvaRxwithaspecificstrategytodevelopstateoftheartcombinationagentsforthesePD1productsandtoseekexitswiththesepharmacompaniesearlyon.SincetheRTO,SalvaRxhascontinueddeliveringitsmissionbyadvancingitsproductsintotheclinicandacquiringexcitingadditionalproductsintheimmunotherapysector.TheGrouphasreviewedhundredsofopportunities,andhasnowinvestedinfourexcitingplatformcompanieswhereitisactivelyhelpingdrivestrategyandexecution.Asofthepublishingofthisreport,SalvaRxportfoliocompanieshaveatotalofeightproductsindevelopmentwithoneintheclinic.Thisistrulyremarkablegiventhetotalcapitalinvestedandreflectscreativedealmakingandstrongutilisationofnon-dilutivecapital.The loss for the year ended 31 December 2016 was £2,445,000 (2015: £466,000). This reflects continuedinvestmentinresearchanddevelopmentof£693,000(2015:£260,000)andexceptionalcostsrelatedtotheRTOof£871,000.Sincetheyearend,theCompanyhasraised$3mintheformofloannotes,ofwhich$2mhascomefromGregBaileyandmyself.Thisadditionalfundingwillhelpustosupportourcurrentbusinessandaddselectivelytoourportfolio whenwe identify the right opportunities. It is our intention to provide further financial support ifrequired.Iamencouragedbytheprogressthathasbeenmadeandamconfidentthatfurtheradvanceswillbemadeinthecurrentfinancialyear. Itwillbequiteexcitingtotracktheperformanceofourtreatments inadvancedcancerpatients.Bythistimenextyear,manymorepatientswillbegivennewoptionstohelpcombattheirdisease.TheSalvaRxteamcontinuestoinnovateandseekouttheworld’sbesttechnologiestobringtocancerpatients.JimMellonNon-executiveChairman29June2017
Enquiries
SalvaRxGroupPLC
IanWalters(ChiefExecutive) Tel:+12034415451
NorthlandCapitalPartnersLimited
NominatedAdviserandBroker
Tel:+44(0)2038616625
MatthewJohnson/EdwardHutton(CorporateFinance)
JohnHowes(CorporateBroking)
PeterhouseCorporateFinanceLimited
JointBroker
LucyWilliams/DuncanVasey
Tel:+44(0)2074690932
CEO’sStrategicReportInitssecondyearofoperations,SalvaRxhascontinuedtoexecuteonitsstrategytogrowitspipelineofproductsandhelpdevelopinnovativemedicinesforthetreatmentofcancer.Thisreportcoversactivitybothduringtheperiodunderreviewandpostperiodendandhighlightsourabilitytoadvancedrugsthroughthedevelopmentandregulatoryprocesstobegintestingonhumans. Ultimatelyourgoal is tohelpasmanycancerpatientsaspossiblewithourmedicines,andwehavebeenabletogrowourinnovativepipelinetoeightproducts.Wearecontinuing to reviewnewopportunities aswell as interfacingwith big pharma companies to discuss possiblestrategiccollaborations.iOxTherapeutics(60.49%subsidiaryundertaking)iOxhasbeenprogressingitstwoproductsthroughpreclinicaldevelopmentandmanufacturing.AlthoughtherehavebeensomechallengeswiththemanufacturingprocessforleadproductIMM60,themanagementteamanditsexpertadvisershaveresolvedtheissuesandiOxisnowprogressingtolargescalemanufacturingforclinicaltrialuse. Therearemanyactivitiesgoingoninparalleltoenablethefirsthumanpatienttobetreatedinthenearfuture.In parallel, the PRECIOUS team, a consortium of academic experts from five leading European universities,continuestomakeprogressinthedevelopmentofoursecondproduct,IMM65,acombinationofIMM60withatumorvaccine(NY-ESO1).ThesedevelopmentactivitiesarefullyfundedthroughaHorizon2020grantwiththeresultbeingthatthereisscopetomakesignificantprogresswithnocosttoiOx.WeannouncedinAugust2016thatTheLudwigInstitutehasgrantediOxtherightstousetheirNY-ESO1cancervaccineonacommercialscale,ifthegrant-fundedclinicaltrialprovestheefficacyofthenewcombinationproduct.iOxcontinuestoprosecuteandprogressitspatentapplicationsandin2016,aUSpatentwasissuedforitsleadprogram.UnderUSPatentNumber9,365,496,IMM60iscoveredasastandalonetreatment,alongwithadditionalusesinaco-formulationwithatumourvaccineorgivenasacombinationtherapyalongsideanimmunomodulatoryagent,includingPD-1pathwayinhibitors.PD-1drugswerepartofthenewvanguardofcancertherapies,allowingthehuman immunesystemtofightcancer, insteadof traditionalchemical treatments,andtherearenowfiveapprovedanti-PD1therapies.iOx’sclinicalprogramsallexploretheiriNKTtechnologyaloneandincombinationwithananti-PD1agent.Itisourgoaltoimprovetheanti-tumorimmuneresponsebytargetingmanycomponentsoftheimmunesystem.IntensityTherapeutics($2millioninvestment,representing8.5%equity)IntensityhasbeenreleasingdataoverthepastyearatmultipleinternationalcongressesalongwithitspartnersattheNationalCancer Institute (adivisionof theNational InstitutesofHealth). Most importantly, thecompanysubmittedanapplicationtobegintestingitsleadproductINT230-6incancerpatientsinbothUnitedStatesandCanada.Intensityannouncedon30May2017thatithasstartedtotreatitsfirstpatientintheclinicaltrial.ThisisanexcitingmilestonewhichrepresentsthepositiveassessmentbytheFDAofresultsofthetrialscarriedoutonanimalsandtherelatedsafetyprocedures,andvalidatestheintegrityofIntensity’smanufacturingprocedures.NewActivitiesin2017Inordertocontinueexecutingourplanstoinvestandoperateotherexcitingopportunitiesinimmunotherapy,inMarch2017SalvaRxLimitedannouncedtheissueofadebtinstrumentforupto$5million.Todateapproximately$3millionhasbeenraised,andIamdelightedtoreportthecontinuingsupportoftwoofourdirectors,GregBaileyand JimMellon,whohaveeach subscribed for$1million. Inaddition, theCompanyeffecteda reorganizationwherebyallitsinterestswereintegratedunderSalvaRxLimited,anditisanticipatedthatthisstructurewillopenadditional avenues for fundraising in the future. Thenew investment into theCompanyhas alreadyenabledSalvaRxLimitedtocompletetwonewinvestments,namelyNekonalOncologyandRiftBiotherapeutics.NekonalOncology
InFebruary2017,weannouncedajointinvestmentwithNekonalSARL,calledNekonalOncology.NekonalwasfoundedbyaformerHarvardprofessorNalânUtku,MDwhowasexploringauniqueantibodyforautoimmunediseases.Latershediscoveredthattheoppositeantibodyheldpromiseforuseinoncologyindications.SalvaRxscientificandbusinessleadershiphasjoinedforceswithDr.UtkutostartNekonalOncologywithalicencetotwooncologyantibodies.Nekonalwasabletorecruitaveryseniorbiotechexecutive,JohnEdwards,chairmanoftwoothercancerimmunotherapycompaniestojointheboardofNekonalOncology.RiftBiotherapeuticsWeadvancedtoRiftBiotherapeuticsInc.(“Rift”)bywayofconvertiblenotestotalamountof$90,000betweenDecember 2016 and January 2017 and further invested $1million in March 2017 for an initial holding ofapproximately 30% in Rift. Rift has a lab in SanDiego California, and has brought the SalvaRx portfolio newcapabilitiesinantibodyengineering.ItsmanagementteamhasbeenstrengthenedbytheappointmentofBriggsMorrison,MDtotheboard.BriggsistheCEOofSyndax(NASDAQ:SNDX)andamanagingdirectorofMPMCapital,ahealthcare-focusedventurecapitalfirmandpreviouslyheldseniorpositionsatAstraZeneca,Pfizer’sandMerck.Rift develops novel antibodies which modulate numerous suppressive factors that exist in the tumormicroenvironment.ThereissomesynergyandpossibilityforcollaborationwiththeNekonalOncologyteam.Inadditiontotheinitialequityinvestment,SalvaRxhastheoptiontoinvestanadditional$1.5millionatthesamevaluationandtoacquirealltheoutstandingsharesofRiftfornewsharesinSalvaRxonthesamebasis.OutlookWeexpectthatour iOxsubsidiaryandinvestmentswillallcontinuetheirmanufacturingandpreclinicaltestingduringtherestoftheyear.WeareanticipatingiOxtostartnewclinicaltrialsin2018andwearealsoexpectingpreliminary clinical trial data from Intensity’shuman studies also in2018. At theSalvaRx corporate level,wecontinuetoidentifypotentialinvestmentsoracquisitions.Weexpecttogrowfurtherbyacquisition,investmentorlicensingarrangementsasweidentifynovelcancerimmunotherapies.Ourhardworkispayingoff,asadvancedcancerpatientscannowparticipateinclinicaltrialsofIntensity’sfirstproduct(INT230-6).Manypeoplearestillsufferingwiththeirdiseaseandhavelimitedoptionsfortreatment.Wearestrivingtoexpediteaccesstoournovelmedicinesbyworkingcloselywithhealthauthoritiesandinnovatinghowweprepareproductsforhumantesting.WebelievethatoverthenexttwoyearsSalvaRxwillseetherewardsoftheseefforts.Thankyouforyourcontinuedsupportaswetrytoimprovethecareforpeoplewithcancer.DrIanWaltersChiefExecutiveOfficer
29June2017
Directors’reportIntroductionTheDirectorspresenttheirreportandfinancialstatementsofSalvaRxGroupPLC(“theGroup”)fortheyearended31December2016.PrincipalactivityTheGroup’sprincipalactivityisthatofdrugdiscoveryanddevelopment,focusedonimmune-oncology.BusinessandfinancialreviewandfuturedevelopmentsTheplansforthefuturearesetoutintheChairman’sStatementandCEO’sStrategicReport.ResultsanddividendsTheGroup’slossfortheyearaftertaxation,netofnon-controllinginterestwas£2.10million(2015:lossof£0.4million).TheDirectorsdonotrecommendthepaymentofadividendfortheyear.Directors TheDirectorsoftheGroupthatservedduringtheyearandsubsequentlywereasfollows:JimMellon,Non-ExecutiveChairmanDrIanWalters,ChiefExecutiveOfficer(appointed22March2016)KamShah,ChiefFinancialOfficer(appointed22March2016)DrGregBailey,Non-ExecutiveDirectorRichardArmstrong,Non-ExecutiveDirectorColinWeinberg,Non-ExecutiveDirectorBiographicaldetailsofservingDirectorscanbefoundintheBoardofDirectorssection.AnnualGeneralMeetingandre-electionofDirectorsTheAnnualGeneralMeetingwillbeheldon31July2017.Directors’InterestsThe table below sets out theDirectors interests in theCompany’sOrdinary Shares, including their connectedpersons,togetherwithdetailsofoptionsheldbythedirectorsoverNewOrdinarySharesoftheCompany:
DirectorNumberofOrdinaryshares
Percentageofissued
sharecapital
NumberofOptions
ExercisePrice
NumberofoptionsiniOx*
Exerciseprice
£
JMellon 13,320,291 36.53% 86,230 23.2p - -
GBailey 13,320,291 36.53% 86,230 23.2p - -
IWalters - - 428,786 35.5p 389 120
KShah - - 364,666 35.5p 130 120
RArmstrong 64,635 0.18% 86,230 23.2p - -
RArmstrong - - 91,166 35.5p - -
CWeinberg 43,103 0.12% 86,230 23.2p - -
CWeinberg - - 91,166 35.5p - -
26,748,320 1,320,704 519 *iOxTherapeuticsLtdisasubsidiary,inwhichtheCompanyholds60.49%equity.Note:optionswithanexercisepriceof23.2pareexercisableatanytimeuntil16February2021.Optionswithanexercisepriceof35.5pareexercisableinthreeequalannualtranchesfrom22March2017,exceptsuchoptionsgrantedtoRichardArmstrongandColinWeinbergwhichareexercisableimmediatelyineventthattheystepdownfromtheBoardinduecourseontheappointmentofnewnon-executivedirectors.
TheinterestsofJimMelloninthetableaboveincludeOrdinarySharesintheCompanyheldbyPortErinBiopharmaInvestmentsLimitedandGallowayLimited.JimMellonholdscontrollinginterestsinthesecompanies.On21April2016,theCompanyissuedatotalofUS$1millionofzerocouponConvertibleLoanNotestoJimMellonandDr.GregBailey.TheLoanNoteshadatermofthreeyearsandwereconvertibleattheNoteholders’discretionatapriceof35.5pperOrdinaryshare.However,inFebruary2017,theentireloannoteliabilitywastransferredtoSalvaRxLimitedandtheNoteholdersagreedtoaccept4,000ordinarysharesofSalvaRxLimitedinfullsettlementoftheLoanNotes.Directors’insuranceandindemnityprovisionsSubjecttotheconditionssetoutintheIsleofManCompaniesAct2006andtheCompany’sArticlesofAssociation,theCompanyhasarrangedappropriateDirectors’insurancetoindemnifytheDirectorsagainstliabilityinrespectofproceedingsbroughtbythirdparties.TheannualcostofthecoverisnotmaterialtotheGroup.SignificantshareholdersOtherthantheDirectors’interestsshownabove,asat23June2017,theCompanyhadbeennotifiedthatthefollowingwereholdersof3%ormoreoftheCompany’sissuedOrdinarySharecapital: NumberofShares %Hon&CoHoldingsLimited 2,122,676 5.79
SharecapitalDetailsoftheissuedsharecapital,togetherwithdetailsofthemovementinissuedsharecapitalduringtheyear,areshowninnote20tothefinancialstatements.PrincipalrisksanduncertaintiesTheprincipalrisksfacedbytheCompanyandtheactionstakentomitigatethem,areshowninthetablebelow:
Risk/Description PrincipalmitigationIntellectualproperty:In common with other companies engaged inpharmaceuticaldevelopment,theCompanyfacestherisk that intellectual property rights necessary toexploititsresearchanddevelopmenteffortsmaynotbe adequately secured or defended. The Group’sintellectual property may also become obsolete,preventingcommercialexploitation.
The Company and its partners actively manage allintellectualproperty(IP)rights,engagingwithspecialiststo apply for and defend IP rights in appropriateterritories.
Researchanddevelopment:The Company may not generate further attractivedrug candidates and candidates already indevelopmentmayfailclinicaltrialsbecauseoflackofefficacy,unacceptablesideeffects,orinsurmountablechallengesinconductingstudiesadequatetosupportregulatoryapprovals.Practicalissues,suchasinabilityto devise acceptable formulations for products orinability to manufacture products at an acceptablecost, may also lead to failure of candidates indevelopment.
Theleadproductcandidatehassuccessfullycompletedacomprehensivepreclinicaldevelopmentprogrammeandthe safety and efficacy profile is well understood. Theclinicaltrialswillbedesignedbasedonthedatafromthedevelopmentprogrammecompletedtodate.
Risk/Description PrincipalmitigationRegulatory:Drug development is a highly regulated activitygoverned by different regulatory authorities indifferentjurisdictions.Itcanbedifficulttopredicttheexact requirements of different regulatory bodies.Decisions by regulators may lead to delays indevelopment and approval of drugs or lack ofmarketingauthorisationsinsomeorallterritories
The Company’s and its partners’ drug developmentteamsincludespecialistsinregulatoryaffairswhoconsultwith other experts to ensure that internal controlprocesses and clinical trial design meet currentregulatory requirements. The Company also engagesdirectlywithregulatoryauthoritieswhenappropriate.
Financial:ThesuccessfuldevelopmentoftheCompany’sassetsrequires financial investment which can come fromrevenues,commercialpartners,orinvestors.Failuretogenerate additional funding from these sourcesmaycompromise the Company’s ability to execute itsbusinessplansortocontinueinbusiness.
The Company has successfully partnered with theUniversityofOxford,whichwillconducttheclinicaltrialswithoutanychargetotheCompany.The Company has raised sufficient additionaldevelopment capital which is considered sufficient tofundcurrentplans.TheGroupoperatesrobustcontrolsoverexpendituresincludingbudgetingandauthorisationofindividualexpenditures.
Commercialandeconomic:The Company may be unable to effectivelycommercialise or license its products to partners ormaynotbeabletoexecutelicensingdealsthatprovidesignificant revenues. Development of alternativetechnologies or products may undermine theCompany’scapacitytogeneraterevenueflowingfromcommercialisationofitsassets.IftheCompany’sdrugsarecommercialised,theymaynotgeneratesignificantrevenuesiftheiruseandsaleisrestrictedbyregulatorsorbyfailureofhealthcarepayorstoprovideadequatereimbursementofdrugcosts.
The Company consults with commercial, clinical, andscientific experts to assess the payer and prescriberenvironment and the potential impact of competingproducts or changes in the economic landscapepertaining to hospital infections. The managementactively monitors performance of key competitors interms of pricing, market share, and prescribingbehaviour.
Operational:The Companymay not be able to recruit and retainappropriately qualified staff. Facilities and otherresourcesmaybecomeunavailable.
The Company’s recruitment processes are tailored toidentifyandattractthebestcandidatesforspecificroles.TheCompanyaimstoprovidecompetitiverewardsandincentives to staff and directors, and informallybenchmarksthelevelofbenefitsprovidedtoitspeopleagainstsimilarcompanies.
KeyPerformanceIndicatorsAtthisstage,thesuccessoftheGroupisdependentuponthesuccessoffutureclinicaltrials.Whentheoutcomesof these trialsareknown, ifandwhen theCompanymoves intoproduction, financial,operational,healthandsafetyandenvironmentalKPIswillbecomerelevantandbemeasuredandreportedaccordingly.PoliticaldonationsTherewerenopoliticaldonationsmadebytheGroupinthecurrentorprioryear.CharitabledonationsTherewerenocharitabledonationsmadebytheGroupinthecurrentorprioryear.GoingconcernTheDirectorshaveareasonableexpectationthattheGrouphasadequateresourcestocontinueinexistencefortheforeseeablefuture,basedonthecashraisedsubsequenttotheyear-end.Thisisexpectedtomeetthenexttwelvemonthsprojectionsoftheoperationalandresearchanddevelopmentactivitiestobecarriedout.
At31December2016,theGrouphadcashandcashequivalentsofapproximately£1.0million.Subsequenttothebalancesheetdate,theGroup’ssubsidiary,SalvaRxLimitedraisedapproximately£2.4million(US$3million)throughdebtfinancing.TheBoardhasevaluatedthecashflowandproposedbudgetandhasreachedtheconclusionthereissufficientfundingforthecurrentworkloadprojecteduntilJune2018.ThisbudgetincludessomeestimationoftheR&DtaxcreditsthatareavailabletotheGroup.Thereissomeminorriskastothetimingandtotalamountofthiscashflow,buttheboardhasconsideredtheavailabilityoffuturefunding,costdeferralandthatexistingshareholdershaveindicatedtheirintentiontoprovidefurtherfundingshouldthisberequired.Thatbeingsaid,majorcostsofdrugdevelopmentgoingforwardarecoveredbyexternalnon-dilutivefunding(collaborativeresearchagreementsandgrants).TheGroupbelievesthattheseavailableresourceswillbesufficienttomeetitscashrequirementsthroughtotheclinicaltrial,foritsoperational,portfolioexpansionthroughstrategicacquisitionsandinvestmentsinentitiesengagedinimmunotherapyandresearchanddevelopmentactivities.AstheGroupcontinuestoincurlosses,transitiontoprofitabilityisdependentuponachievingalevelofrevenuesadequatetosupporttheGroup’scoststructureandunless,anduntildoingso,intendstofundfutureoperationsthroughadditionaldebtorequityofferings.Therecanbenoassurance,however,thatadditionalfundingwillbeavailableontermsacceptabletotheGroup,ifatall.TheDirectorsthereforeconsideritappropriatetopreparethefinancialstatementsonagoingconcernbasis.PaymentofsuppliersItistheGroup’spolicythatpaymentstosuppliersaremadeinaccordancewithtermsandconditionsagreedbetweentheGroupanditssuppliers.Theaveragepaymentperiodforcreditorsfortheyearwas40days(2015:31days).PostbalancesheeteventsEventsafterthebalancesheetdatehavebeendisclosedinnote27tothefinancialstatements.StatementastodisclosureofinformationtotheauditorEachDirectorinofficeatthedateofthisreporthasconfirmed,asfarasheisaware,thatthereisnorelevantauditinformationofwhichtheauditorisunaware.EachsuchDirectorhasconfirmedthathehastakenallthestepsthatheoughttohavetakenasaDirectorinordertomakehimselfawareofanyrelevantauditinformationandtoestablishthattheauditorisawareofthatinformation.AuditorAresolutiontoreappointRSMUKAuditLLPasauditor,atafeetobeagreed,willbeproposedbytheBoard.TheDirectors’ReportwasapprovedbytheBoardofDirectorsandsignedonitsbehalfby:KamShahDirector29June2017
CorporateGovernanceStatementTheDirectorsrecognisetheimportanceoftheFinancialReportingCouncil’sUKCorporateGovernanceCode(compliancewithwhichisnotmandatoryforcompaniesadmittedtotradingonAIM)andintendtocomplywithitsprinciplessofarasispracticableandappropriategiventhenatureandsizeoftheCompanyandthesizeandconstitutionoftheBoard.TheDirectorsalsointendtocomplywiththeprinciplesoftheCorporateGovernanceGuidelinesforAIMCompaniespublishedbytheQuotedCompaniesAlliancein2010,totheextentthattheyconsideritappropriateandhavingregardtotheCompany’ssize,boardstructure,stageofdevelopmentandresources.TheDirectorsholdregularboardmeetingsandareresponsibleforformulating,reviewingandapprovingtheCompany’sstrategy,budgetandmajoritemsofcapitalexpenditure.Anauditcommittee,aremunerationcommitteeandanominationcommitteeareinplacewithformallydelegatedrulesandresponsibilities.Eachofthesecommitteesmeetsasandwhenappropriatesaveinthecaseoftheremunerationandauditcommitteeswhichmeetatleasttwiceeachyear.TheAuditCommitteecomprisesRichardArmstrong(Chairman),JimMellonandDrGregBailey.TheAuditCommittee,interalia,determinesandexaminesmattersrelatingtothefinancialaffairsoftheCompanyincludingthetermsofengagementoftheCompany’sauditorsand,inconsultationwiththeauditor,thescopeoftheaudit.ItreceivesandreviewsreportsfrommanagementandtheCompany’sauditorsrelatingtothehalfyearlyandauditedannualaccountsandtheaccountingandtheinternalcontrolsystemsinusethroughouttheEnlargedGroup.TheRemunerationCommitteecomprisesJimMellon(Chairman),RichardArmstrong,DrGregBaileyandColinWeinberg.TheRemunerationCommitteereviewsandmakesrecommendationsinrespectoftheDirectors’remunerationandbenefitspackages,includingshareoptionsandthetermsoftheirappointment.TheRemunerationCommitteealsomakerecommendationstotheBoardconcerningtheallocationofOptionsunderthePlan.TheNominationCommitteecomprisesColinWeinberg(Chairman),JimMellonandRichardArmstrong.TheNominationCommitteemonitorsthesizeandcompositionoftheBoardandtheotherBoardcommitteesandisresponsibleforidentifyingsuitablecandidatesforBoardmembership.
StatementofDirectors’ResponsibilitiesThedirectorsareresponsibleforpreparingtheDirectors’Reportandthefinancialstatementsinaccordancewithapplicablelawandregulations.Companylawrequiresthedirectorstopreparegroupfinancialstatementsinaccordancewithgenerallyacceptedaccountingprinciples.ThedirectorsarerequiredbytheAIMRulesoftheLondonStockExchangetopreparegroupfinancialstatementsinaccordancewithInternationalFinancialReportingStandards(“IFRS”)asadoptedbytheEuropeanUnion(“EU”).Thefinancialstatementsofthegrouparerequiredbylawtogiveatrueandfairviewofthestateofthegroup’saffairsattheendofthefinancialyearendandoftheprofitorlossofthegroupforthatperiodandarerequiredbyIFRSasadoptedbytheEUtopresentfairlythefinancialpositionofthegroupandthefinancialperformanceofthegroup.Inpreparingthestatements,thedirectorsshould:
• selectsuitableaccountingpoliciesandthenapplythemconsistently;• makejudgementsandaccountingestimatesthatarereasonableandprudent;• statewhethertheyhavebeenpreparedinaccordancewithIFRSadoptedbytheEU;and• preparethefinancialstatementsonagoingconcernbasisunlessitisinappropriatetopresumethatthe
groupwillcontinueinbusiness.
Thedirectorsareresponsibleforkeepingreliableaccountingrecordswhichcorrectlyexplainthegroup’stransactionsandenablethemtodetermine,withreasonableaccuracy,thefinancialpositionofthegroupatanytimeandallowfinancialstatementstobeprepared.Theyarealsoresponsibleforsafeguardingtheassetsofthegroupandhencefortakingreasonablestepsforthepreventionanddetectionoffraudandotherirregularities.ThedirectorsareresponsibleforthemaintenanceandintegrityofthecorporateandfinancialinformationincludedontheSalvaRxGroupPLCwebsite.LegislationinIsleofMangoverningthepreparationanddisseminationoffinancialstatementsmaydifferfromlegislationinotherjurisdictions.
SALVARXGROUPPLCINDEPENDENTAUDITOR’SREPORTTOTHEMEMBERSOFSALVARXGROUPPLC
OpiniononfinancialstatementsWehaveauditedthegroupfinancialstatements(“thefinancialstatements”)whichcomprisetheConsolidatedStatementofComprehensiveIncome,ConsolidatedBalanceSheet,ConsolidatedCashFlowStatement,ConsolidatedStatementofChangesinEquityandtherelatednotes.ThefinancialreportingframeworkthathasbeenappliedintheirpreparationisapplicablelawandInternationalFinancialReportingStandards(IFRSs)asadoptedbytheEuropeanUnion.Inouropinion,thefinancialstatements:• giveatrueandfairviewofthestateoftheGroup’saffairsasat31December2016andoftheGroup’sloss
fortheyearthenended;• havebeenproperlypreparedinaccordancewithIFRSsasadoptedbytheEuropeanUnion;and• havebeenproperlypreparedinaccordancewiththerequirementsoftheIsleofManCompaniesAct2006.OthermatterDuetotheapplicationofreverseacquisitionaccounting(asexplainedinnote3),theconsolidatedcomparativefiguresareunaudited.ScopeoftheauditofthefinancialstatementsAdescriptionofthescopeofanauditof financialstatementsarisingfromtherequirementsof InternationalStandards on Auditing (UK and Ireland) is provided on the Financial Reporting Council’s website athttp://www.frc.org.uk/auditscopeukprivateRespectiveresponsibilitiesofdirectorsandauditorAs more fully explained in the Directors’ Responsibilities Statement set out on page 13, the directors areresponsibleforthepreparationofthefinancialstatementsandforbeingsatisfiedthattheygiveatrueandfairview. Our responsibility is to audit and express an opinion on the financial statements in accordancewithapplicablelawandInternationalStandardsonAuditing(UKandIreland).ThosestandardsrequireustocomplywiththeAuditingPracticesBoard’s(APB’s)EthicalStandardsforAuditors.We read the other financial and non-financial information contained in the annual report and consider theimplicationsforourreportifwebecomeawareofanymaterialinconsistencywiththefinancialstatementsorwithknowledgeacquiredbyusinthecourseofperformingtheaudit,oranymaterialmisstatementoffactwithintheotherinformation.Wealsoreadtheinformationinthedirectors'reportandconsidertheimplicationsforourreportifwebecomeawareofanymaterialinconsistencywiththefinancialstatements.Thisreportismadesolelyinaccordancewithsection80CoftheIsleofManCompaniesAct2006.Ourauditworkhasbeenundertakensothatwemightstatetothecompany’smembersthosematterswearerequiredtostatetotheminanauditor’sreportandfornootherpurpose.Tothefullestextentpermittedbylaw,wedonotacceptorassumeresponsibilitytoanyoneotherthanthecompanyandthecompany’smembersasabody,forourauditwork,forthisreport,orfortheopinionswehaveformed.
MICHAELTHORNTON(SeniorStatutoryAuditor)ForandonbehalfofRSMUKAUDITLLP,StatutoryAuditorCharteredAccountants2WhitehallQuayLeedsLS14HG29June2017
ConsolidatedStatementofComprehensiveIncomeFortheyearended31December2016
*Inaccordancewithnote3,andtheadoptionofreservetakeoveraccountingprinciples,comparativesarefortheconsolidatedresultsofSalvaRxLimited
Notes
Yearended31December
2016£’000
Unaudited
*6May2015to31
December2015£’000
Researchanddevelopment (693) (260)Exceptionalitems 7 (871) -Otheroperatingcosts (913) (221) Operatingloss 8 (2,477) (481) Financingincome 17 1 - Lossbeforetax (2,476) (481)Tax 11 31 15 Lossandcomprehensivelossfortheyear (2,445) (466) Lossandcomprehensivelossattributableto: Equityholdersoftheparent (2,038) (326)Non-controllinginterest (407) (140) ___________ __________ (2,445) (466) Lossperordinaryshare Basicanddiluted,pencepershare 12 (0.06p) (0.01p)
ConsolidatedBalanceSheetAsat31December2016
Notes
2016£’000
Unaudited2015*£’000
Assets Non-currentassets Investments 13 1,431 -Intangibleassets 14 1,184 1,366 2,615 1,266 Currentassets Tradeandotherreceivables 15 34 236Cashandcashequivalents 16 967 567 1,001 803 Totalassets 3,616 2,169 Liabilities Currentliabilities Tradeandotherpayables 18 (295) (244) (295) (244) Non-currentliabilities Equityoptiononconvertibleloan 17 (78) -Convertibleloannotes 17 (616) -Deferredtaxliabilities 11 (201) (232) ________ _________ (895) (232) ________ _________Totalliabilities (1,190) (476)
Netassets 2,426 1,693 Equity Sharecapital 20 911 155Sharepremiumaccount 22 - 52,533Reverseacquisitionreserve 23 3,065 (51,748)Ownshares 21 (215) -Share-basedpaymentreserves 24 382 25Accumulateddeficit (2,364) (326) Equityattributabletoequityholdersoftheparent 1,779 639Non-controllinginterests 647 1,054 _________ __________Totalequity
2,426
1,693
*Inaccordancewithnote3,andtheadoptionofreversetakeoveraccountingprinciples,comparativesarefortheconsolidatedfinancialpositionofSalvaRxLimited.
ThefinancialstatementsofSalvaRXGroupplcwereapprovedbytheBoardofDirectorsandauthorisedforissueon29June2017.Theyweresignedonitsbehalfby:
KamShahChiefFinancialOfficer
Notes1to27formpartofthesefinancialstatements.
ConsolidatedCashFlowStatementFortheyearended31December2016
Yearended31December
2016£'000
Unaudited*6May2015
to31December
2015£'000
Lossfortheyear (2,445) (466)
Adjustmentsfor: Deferredtaxation (31) (15)Amortisation 182 91Share-basedpayments 357 25Financecost (1) -Noncashexceptionalitems(note7) 563 -
Operatingcashflowsbeforemovementsinworkingcapital (1,375) (365)
Decrease/(increase)inreceivables 202 (237)
(Decrease)/increaseinpayables (332) 229
Cashusedinoperations (1,505) (373)
Taxationpaid - -
Netcashoutflowfromoperatingactivities (1,505) (373)
Investingactivities
Cashacquiredthroughreverseacquisition 2,564 -Purchaseoftradinginvestment (1,431) -
Netcashobtainedininvestingactivities 1,133 -
Financingactivities
Proceedsfromtheissueofsharecapital - 940
Proceedsonissueofconvertibleloannotes 760 -
Netcashfromfinancingactivities 760 940
Netincreaseincashandcashequivalents 388 567
Cashandcashequivalentsatbeginningofyear 567 -
Effectofexchangerateoncashflow 12 -
Cashandcashequivalentsatendofyear 967 567
*Inaccordancewithnote3,andtheadoptionofreversetakeoveraccountingprinciples,comparativesarefortheconsolidatedcashflowsofSalvaRxLimited.
ConsolidatedStatementofChangesinEquityFortheyearended31December2016
Equityattributabletoequityholdersoftheparent
Sharecapital(note20)
Sharepremium(note22)
Reverseacquisition
reserve(note23)
Ownshares(note21)
Share-based
paymentreserves
Accumulateddeficit Total
Non-controlling
interest
Totalequity
£’000 £’000 £’000 £’000 £’000 £’000 £’000 £’000 £’000At1January2016 155
52,533 (51,748)
-
25
(326) 639
1,054
1,693
Netlossoftheyear - - - - - (2,038) (2,038) (407) (2,445)
Totalcomprehensiveincome - - - - - (2,364) (1,399) 647 (752)
Transactionswithownersintheircapacityasowners:
-Issueofequityforcash 136 1,813 (1,949) - - - - - - -Costofshareissue - (173) 173 - - - - - --Reverseacquisition 620
8,180 (5,764)
(215)
-
- 2,821
-
2,821
Cancellationofsharepremiumaccount - (62,353) 62,353 - - - - - - Sharebasedpaymentcharge - - - - 357 - 357 - 357
Totaltransactionswithownersintheircapacityasowners 756
(52,533) 54,813
(215)
357
- 3,178
-
3,178
At31December2016 911 - 3,065 (215) 382 (2,364) 1,779 647 2,426
Equityattributabletoequityholdersoftheparent
Sharecapital(note20)
Sharepremium(note22)
Reverseacquisition
reserve(note23)
Ownshares(note21)
Share-based
paymentreserves
Accumulateddeficit Total
Non-controlling
interest
Totalequity
£’000 £’000 £’000 £’000 £’000 £’000 £’000 £’000 £’000 Balanceasat6May2015 155 52,533 (52,688) - - - - - - Netlossfortheperiod - - - - - (326) (326) (140) (466)
Totalcomprehensiveincome - - - - - (326) (326) (140) (466)
Transactionswithownersintheircapacityasowners:
-SharecapitalissuedbySalvaRxLimited - - 940 - - - 940 - 940-Non-controllinginterestarisingonacquisitionofiOxTherapeuticsLimited(note14) -
- -
-
-
- -
1,194
1,194-Share-basedpaymentcharge -
- -
-
25
- 25
-
25
Totaltransactionswithownersintheircapacityasowners -
- 940
-
25
- 965
1,194
2,159
At31December2015 155 52,533 (51,748) - 25 (326) 639 1,054 1,693
NotestotheconsolidatedfinancialstatementsFortheyearended31December2016
1 GeneralinformationSalvaRxGroupPLC(the‘Company’and,togetherwithitssubsidiaries,the‘Group’)isincorporatedintheIsleofMan,BritishIslesundertheIsleofManCompaniesAct2006.TheaddressoftheregisteredofficeisCommerceHouse,1BowringRoad,Ramsey,IsleofMan,BritishIsles,IM82LQ.On22March2016,theCompanyacquiredthe88.9%ofthesharecapitalofSalvaRxLimitednotalreadyownedbyitforaconsiderationof£8.8msatisfiedbytheissueof24,788,732NewOrdinaryShares.TheAcquisitionwasofsufficientsizetoconstituteareversetakeoverundertheAIMRulesandisaccountedforasareverseacquisitionin these financial statements (note3).As a result, SalvaRx Limited is anaccountingacquirer and comparativefiguresprovidedinthesefinancialstatementsarethoseofSalvaRxLimited.Inconjunctionwiththeabove,thenameoftheCompanywaschangedtoSalvaRxGroupPLC,theshareswereconsolidatedon thebasisof1newOrdinaryShare forevery100OrdinaryShares, and therewasaplacingof5,492,958newOrdinarySharesatapriceof35.5ppersharetoraise£1.95mbeforeexpenses.The principal activity of the Group is drug development, pre-clinical development with particular focus ondevelopingseriesofcompoundsforcancerimmunotherapy.Thesefinancialstatementsarepresentedinpoundssterling,whichistheGroup’sfunctionalandpresentationalcurrency,andallvaluesareroundedtothenearestthousands(£’000)exceptlossperordinaryshareandcertainfiguresinthenotes.2 AdoptionofnewandrevisedStandardsStandardsaffectingpresentationanddisclosureFor the preparation of these consolidated financial statements, the following newor amended standards aremandatoryforthefirsttimeforthefinancialyearbeginning1January2016:• AmendmentstoIAS1titledDisclosureInitiative(issuedinDecember2014)–Theamendments,applicableto
annual periods beginning on or after 1 January 2016, clarify guidance onmateriality and aggregation, thepresentationofsubtotals,thestructureoffinancialstatementsandthedisclosureofaccountingpolicies.TheamendmentshadnomaterialeffectontheGroup’sconsolidatedfinancialstatements.
• AmendmentstoIAS27titledEquityMethodinSeparateFinancialStatements(issuedinAugust2014)–The
amendments,applicabletoannualperiodsbeginningonorafter1January2016,reinstatetheequitymethodoptionallowingentitiestousetheequitymethodtoaccountforinvestmentsinsubsidiaries,jointventuresandassociates in their separate financial statements. This amendment has no effect on consolidated financialstatements.
• Amendment to IFRS 5 (Annual Improvements to IFRSs 2012–2014 Cycle, issued in September 2014) - The
amendment,applicableprospectivelytoannualperiodsbeginningonorafter1January2016,addsspecificguidancewhenanentityreclassifiesanasset(oradisposalgroup)fromheldforsaletoheldfordistributiontoowners,orviceversa,andforcaseswhereheld-for-distributionaccountingisdiscontinued.ThisamendmenthadnoeffectontheGroup’sconsolidatedfinancialstatements.
• Amendment to IFRS 7 (Annual Improvements to IFRSs 2012–2014 Cycle, issued in September 2014) - The
amendment, applicable to annual periods beginning on or after 1 January 2016, adds guidance to clarifywhetheraservicingcontractiscontinuinginvolvementinatransferredasset.TheamendmenthadnoeffectontheGroup’sconsolidatedfinancialstatements.
2 AdoptionofnewandrevisedStandards(continued)• AmendmentstoIFRS10,IFRS12andIAS28titledInvestmentEntities:ApplyingtheConsolidationException
(issuedinDecember2014)–Theamendments,applicabletoannualperiodsbeginningonorafter1January2016,clarifytheapplicationoftheconsolidationexceptionforinvestmententitiesandtheirsubsidiaries.The
amendmentshadnoeffectontheGroup’sconsolidatedfinancialstatements.
Atthedateofauthorisationofthefinancialstatements,thefollowingStandardsandInterpretationswhichhavenotbeenappliedinthefinancialstatementswereinissuebutnotyeteffective(andinsomecaseshadnotyetbeenadoptedbytheEU):• Amendments to IAS7 titledDisclosure Initiative (issued in January2016)–Theamendments,applicable to
annualperiodsbeginningonorafter1January2017.• AmendmentstoIAS12titledRecognitionofDeferredTaxAssetsforUnrealisedLosses(issuedinJanuary2016)
–Theamendments,applicabletoannualperiodsbeginningonorafter1January2017.• AmendmentstoIFRS2titledClassificationandMeasurementofShare-basedPaymentTransactions(issuedin
June2016)-Theamendments,applicabletoannualperiodsbeginningonorafter1January2018.• IFRS 9 Financial Instruments (issued in July 2014) – This standardwill replace IAS 39 (and all theprevious
versionsofIFRS9)effectiveforannualperiodsbeginningonorafter1January2018.• AmendmentstoIFRS10andIAS28titledSaleorContributionofAssetsbetweenanInvestoranditsAssociate
orJointVenture(issuedinSeptember2014).Theeffectivedateoftheamendments, initiallysetforannualperiods beginning on or after 1 January 2016, is now deferred indefinitely but earlier application is stillpermitted.
• IFRS15RevenuefromContractswithCustomers(issuedinMay2014andamendedforclarificationsinApril2016)-Thenewstandard,effectiveforannualperiodsbeginningonorafter1January2018,replacesIAS11,IAS18andtheirinterpretations.
• IFRS16Leases(issuedinJanuary2016)-Thenewstandard,effectiveforannualperiodsbeginningonorafter1January2019,replacesIAS17anditsinterpretations.
TheDirectorsdonotexpectthattheadoptionoftheseStandardsorInterpretationsinfutureperiodswillhaveamaterialimpactonthefinancialstatementsoftheGroup.3 ReverseacquisitiontransactionOn30September2015,theCompanyacquired11.14%oftheissuedsharecapitalofSalvaRxLimited(“SalvaRx”),aprivatecompanyincorporatedintheBritishVirginIslands.On22March2016,theCompanyacquiredtheremaining issuedsharecapitalofSalvaRxby issuing24,788,732ordinarysharesoftheCompany.
AlthoughthetransactionresultedinSalvaRxbecomingawhollyownedsubsidiaryoftheCompany,thetransactionconstitutes a reverse acquisition in asmuch as the shareholders of SalvaRxowna substantialmajority of theoutstandingordinarysharesoftheCompanyandfouroutofsixmembersoftheBoardofDirectorsoftheCompanyareSalvaRxshareholdersandmanagement.
Insubstance,theshareholdersofSalvaRxacquiredacontrollinginterest intheCompanyandthetransactionhasthereforebeenaccountedforasareverseacquisitioninaccordancewithguidanceprovidedinIFRS2Share-basedpaymentandIFRS3BusinessCombinations.AstheCompanypreviouslydiscontinueditsinvestmentactivitiesandwasengagedinacquiringSalvaRxandraisingequityfinancingtoprovidetherequiredfundingfortheoperationsoftheproposedacquisitionandre-listingonAIM,itdidnotmeetthedefinitionofabusinessaccordingtothedefinitioninIFRS3.Accordingly,thisreverseacquisitiondoesnotconstituteabusinesscombinationandinaccordancewithIFRICguidancethedifferencebetweentheequityvaluegivenupbytheSalvaRxshareholdersandtheshareofthefairvalueofnetassetsgainedbytheSalvaRxshareholdersischargedtothestatementofcomprehensiveincomerepresentingthecostofacquiringanAIMquotedlisting.Inaccordancewithreverseacquisitionaccountingprinciples,theseconsolidatedfinancialstatementsrepresentacontinuationoftheconsolidatedfinancialstatementsofSalvaRxandinclude:a. TheassetsandliabilitiesofSalvaRxandiOxTherapeuticsLimited(its60.49%ownedsubsidiaryacquiredon24
June2015)(“iOx”)attheirpre-acquisitioncarryingamountsandtheirresultsforbothperiods;andb. Theassetsand liabilitiesof theCompanyasat31December2016and it’s results from23March2016to31
December2016,
ThefairvalueofnetassetsoftheCompanyacquiredbySalvaRxwasasfollows: £’000 Cash 2,564Otherassets 14Liabilities (309) 2,269
ThedeemedcostoftheacquisitionrepresentsthedifferencebetweenthefairvalueoftheshareholdinggivenupbySalvaRxLimitedshareholdersandtheshareofthefairvalueoftheassetsandliabilitiesoftheCompanygainedbythoseshareholders.Whilstthedeemedcostofacquisitionisrecordedinequity,thesharecapitalandsharepremiummustreflectthatoftheCompanyandthereforethedifferencearisingisrecordedinthereverseacquisitionreserve(note23).Consequently,basedonanassessmentofthepurchaseconsiderationforan88.9%holdinginSalvaRxof£8.8m,thedeemedcostoftheacquisitionoftheCompanybySalvaRxis£2,832,000.Thedifferencebetweenthisdeemedcostandthefairvalueofthenetassetsacquired(above)of£563,000hasbeenexpensedinaccordancewithIFRS2,Sharebasedpayments,reflectingtheeconomiccosttotheSalvaRxshareholdersofacquiringaquotedentity.Givenitssignificance,thiscosthasbeentreatedasanexceptionalitem(note7).Atthepointofacquisition,thenetassetsofthecompanyincludeda£215,000investmentinSalvaRxLimited.AsSalvaRxLimitedistheacquirerunderreverseaccountingprinciples,thisinvestmenthasbeentreatedasapurchaseofownsharesandrecordedinequity(note21).4 SummaryofsignificantaccountingpoliciesBasisofaccountingThe financial statements have been prepared in accordancewith International Financial Reporting Standards(“IFRSs”)as issuedby the InternationalAccountingStandardsBoard (“IASB”)andasadoptedby theEuropeanUnion(“EU”),andthereforetheGroupfinancialstatementscomplywithArticle4oftheEUIASRegulation.Thefinancialstatementshavebeenpreparedonthehistoricalcostconventionbasisexceptfortherevaluationofcertain financial instruments. Historic cost is generally based on the fair value of the consideration given inexchangefortheassets.Theprincipalaccountingpoliciesadoptedaresetoutbelow.GoingconcernTheGroup’sbusinessactivities,togetherwiththefactorslikelytoaffectitsfuturedevelopmentandposition,aresetoutintheDirectors’Report.TheconsolidatedfinancialstatementsofthegrouphavebeenpreparedonabasiswhichassumesthattheGroupwillcontinueasagoingconcern,whichcontemplatestherealisationofassetsandsatisfactionofliabilitiesandcommitmentsinthenormalcourseofbusiness.At31December2016,theGrouphadcashandcashequivalentofapproximately£1.0million.Subsequenttothebalance sheetdate, theGroup’s subsidiary, SalvaRxLimited raisedapproximately£2.4million (US$3.0million)throughdebtfinancing.TheBoardhasevaluatedthecashflowandproposedbudgetandhasreachedtheconclusionthereissufficientfundingforthecurrentworkloadprojecteduntilJune2018.ThisbudgetincludessomeestimationoftheR&DtaxcreditsthatareavailabletotheGroup.Thereissomeminorrisktothetimingandtotalamountofthiscashflow,buttheboardhasconsideredtheavailabilityoffuturefunding,costdeferralandthatexistingshareholdershaveindicatedtheirintentiontoprovidefurtherfundingshouldthisberequired.Thatbeingsaid,majorcostsofdrugdevelopmentgoingforwardarecoveredbyexternalnon-dilutivefunding(collaborativeresearchagreementsandgrants).TheGroupbelievesthattheseavailableresourceswillbesufficienttomeetitscashrequirementsthroughtotheclinical trial, for its operational, portfolio expansion through strategic acquisitions and investments in entitiesengagedinimmunotherapyandresearchanddevelopmentactivities.
AstheGroupcontinuestoincurlosses,transitiontoprofitabilityisdependentuponachievingalevelofrevenuesadequatetosupporttheGroup’scoststructureandunlessanduntildoingso,intendstofundfutureoperationsthroughadditionaldebtorequityofferings.Therecanbenoassurance,however,thatadditionalfundingwillbeavailableontermsacceptabletotheGroup,ifatall.BasisofconsolidationTheconsolidatedfinancialstatementsincorporatethefinancialstatementsoftheCompanyandentitiescontrolledbytheCompany(itssubsidiaries)madeupto31Decembereachyear.ControlisachievedwheretheCompanyhasthepowertogovernthefinancialandoperatingpoliciesofan investeeentitysoastoobtainbenefitsfromitsactivities.The results of subsidiaries acquired or disposed of during the year are included in the consolidated incomestatementfromtheeffectivedateofacquisitionoruptotheeffectivedateofdisposal,asappropriate.Wherenecessary,adjustmentsaremadetothefinancialstatementsofsubsidiariestobringaccountingpoliciesusedintolinewiththoseusedbytheGroup.Allintra-Grouptransactions,balances,incomeandexpensesareeliminatedonconsolidation.TheseconsolidatedfinancialstatementsincludetheaccountsoftheCompanyand:i. SalvaRxLimited,(“SalvaRx”)incorporatedon6May2015intheBritishVirginIslands.SalvaRxisawhollyowned
subsidiaryoftheCompany.ii iOxTherapeuticsLimited(“iOx”)incorporatedintheU.K.asaprivatecompany(CompanyNumber9430782)
undertheCompaniesAct2006on10February,2015.SalvaRxholds60.49%equityiniOx.Theseconsolidatedfinancialstatementshavebeenpreparedusingreverseacquisition,asdetailedinnote3.SignificantaccountingpoliciesResearchandDevelopmentExpenses(i) ResearchanddevelopmentExpenditureonresearchactivities,undertakenwiththeprospectofgainingnewscientificortechnicalknowledgeandunderstanding,isrecognisedinprofitorlossasincurred.Developmentactivitiesinvolveaplanordesignfortheproductionofneworsubstantiallyimprovedproductsandprocesses.Developmentexpendituresare capitalisedonly ifdevelopment costs canbemeasured reliably, theproduct or process is technically and commercially feasible, future economic benefits are probable, and theCompany intends to, and has sufficient resources to, complete development and to use or sell the asset.Nodevelopmentcostshavebeencapitalisedtodate.Researchanddevelopmentexpensesincludealldirectandindirectoperatingexpensessupportingtheproductsindevelopment(ii) SubsequentexpenditureSubsequent expenditure is capitalized only when it increases the future economic benefits embodied in thespecificassettowhichitrelates.Allotherexpendituresarerecognizedinprofitorlossasincurred.(iii) ClinicaltrialexpensesClinicaltrialexpensesareacomponentoftheCompany’sresearchanddevelopmentcosts.Theseexpensesincludefeespaid to contract researchorganizations, clinical sites, andotherorganizationswho conductdevelopmentactivitiesontheCompany’sbehalf.Theamountofclinicaltrialexpensesrecognizedinaperiodrelatedtoclinicalagreementsarebasedonestimatesoftheworkperformedusinganaccrualbasisofaccounting.Theseestimatesincorporatefactorssuchaspatientenrolment,servicesprovided,contractualterms,andpriorexperiencewithsimilarcontracts.(iv) GovernmentgrantsGovernmentgrantsrelatetofinancialgrantsfromgovernments,publicauthorities,andsimilarlocal,nationalorinternationalbodies.ThesearerecognisedwhenthereisareasonableassurancethattheCompanywillcomplywiththeconditionsattachingtothem,andthatthegrantwillbereceived.Governmentgrantsrelatingtoresearchanddevelopmentareoff-setagainsttherelevantcosts.
BusinessCombinationsTheCompanyapplies the acquisitionmethod to account for all acquiredbusinesses,whereby the identifiableassetsacquiredandtheliabilitiesassumedaremeasuredattheiracquisition-datefairvalues(withfewexceptionsasrequiredbyIFRS3BusinessCombinations).Theconsiderationtransferredinabusinesscombinationismeasuredatfairvalue,whichiscalculatedasthesumoftheacquisition-datefairvaluesoftheassetstransferred,theliabilitiesincurredandtheequityinterestsissuedbytheCompany.Acquisition-relatedcosts(e.g.finder’sfees,consultingfees,administrativecosts)arerecognizedasexpensesintheperiodsinwhichthecostsareincurredandtheservicesarereceived.Onacquisitiondate,goodwillismeasuredas theexcessof theaggregateofconsideration transferred,anynon-controlling interests in theacquiree,andacquisition-date fair value of the Company's previously held equity interest in the acquiree (if businesscombinationachievedinstages)overthenetoftheacquisition-dateamountsoftheidentifiableassetsacquiredandtheliabilitiesassumed.If,afterappropriatereassessment, theamountascalculatedabove isnegative, it is recognized immediately inprofitorlossasabargainpurchasegain.Atacquisitiondate,non-controllinginterestsintheacquireethatarepresentownershipinterestsandentitletheirholderstoaproportionateshareoftheentity'snetassetsintheeventofliquidationaremeasuredateitherfairvalueor thepresentownership instruments’proportionateshare in the recognizedamountsof theacquiree'sidentifiable net assets. This choice ofmeasurement ismade separately for each business combination.Othercomponents of non-controlling interests are measured at their acquisition-date fair values, unless otherwiserequiredbyIFRS.The acquisition-date fair value of any contingent consideration is recognised as part of the considerationtransferredbytheCompanyinexchangefortheacquiree.Changesinthefairvalueofcontingentconsiderationthatresultfromadditionalinformationobtainedduringthemeasurementperiod(maximumoneyearfromtheacquisitiondate)aboutfactsandcircumstancesthatexistedattheacquisitiondateareadjustedretrospectivelyagainstgoodwill.IntangibleAssetsAcquiredinbusinesscombinationsIntangible assets acquired in a business combination and recognised separately from goodwill are initiallyrecognisedattheirfairvalueattheacquisitiondate(whichisregardedastheircost).Subsequenttoinitialrecognition,intangibleassetsacquiredinabusinesscombinationarereportedatcostlessaccumulatedamortisationandaccumulated impairment loses,on the samebasisas intangibleassets thatareacquiredseparately.ForeigncurrenciesTheindividualfinancialstatementsofeachGroupcompanyarepresentedinthecurrencyoftheprimaryeconomicenvironment in which it operates (its functional currency). For the purpose of the consolidated financialstatements,theresultsandfinancialpositionofeachGroupcompanyareexpressedinpoundsterling,whichisthefunctionalcurrencyoftheCompany,andthepresentationcurrencyfortheconsolidatedfinancialstatements.In preparing the financial statements of the individual companies, transactions in currencies other than thefunctionalcurrencyofeachGroupcompany(“foreigncurrencies”)arerecordedinthefunctionalcurrencyattheratesofexchangeprevailingonthedatesofthetransactions.Ateachbalancesheetdate,monetaryassetsandliabilities thataredenominated in foreigncurrenciesare retranslated into the functionalcurrencyat theratesprevailingonthebalancesheetdate.Non-monetaryassetsandliabilitiescarriedatfairvaluethataredenominatedinforeigncurrenciesaretranslatedattheratesprevailingatthedatewhenthefairvaluewasdetermined.Non-monetaryitemsthataremeasuredintermsofhistoricalcostinaforeigncurrencyarenotretranslated.Forthepurposeofpresentingconsolidatedfinancialstatements,theassetsandliabilitiesofthegroup’sforeignoperationsaretranslatedatexchangeratesprevailingonthebalancesheetdate.Incomeandexpenseitemsaretranslatedattheaverageexchangeratesfortheperiod,unlessexchangeratesfluctuatesignificantlyduringtheperiod,inwhichcasetheexchangeratesatthedateoftransactionsareused.Exchangedifferencesarising,ifany,arerecognisedinothercomprehensiveincomeandaccumulatedinequity(attributedtonon-controllinginterestasappropriate).
TaxationThetaxexpenserepresentsthesumofthetaxcurrentlypayableanddeferredtax.Thetaxcurrentlypayableisbasedontaxableprofitfortheyear.Taxableprofitdiffersfromnetprofitasreportedintheincomestatementbecauseitexcludesitemsofincomeorexpensethataretaxableordeductibleinotheryears,anditfurtherexcludesitemsthatarenevertaxableordeductible.TheGroup’sliabilityforcurrenttaxiscalculatedusingtaxratesthathavebeenenactedorsubstantivelyenactedbythebalancesheetdate.Deferredtaxisthetaxexpectedtobepayableorrecoverableondifferencesbetweenthecarryingamountsofassets and liabilities in the financial statements and the corresponding tax bases used in the computation oftaxableprofit,andisaccountedforusingthebalancesheetliabilitymethod.Deferredtaxliabilitiesaregenerallyrecognisedforalltaxabletemporarydifferences,anddeferredtaxassetsarerecognisedtotheextentthatit isprobablethattaxableprofitswillbeavailableagainstwhichdeductibletemporarydifferencescanbeutilised.Suchassetsandliabilitiesarenotrecognisedifthetemporarydifferencearisesfromtheinitialrecognitionofgoodwill,orfromtheinitialrecognition(otherthaninabusinesscombination)ofotherassetsandliabilitiesinatransactionthataffectsneitherthetaxprofitnortheaccountingprofit.Deferredtaxliabilitiesarerecognisedfortaxabletemporarydifferencesarisingoninvestmentsinsubsidiariesandassociates,andinterestsinjointventures,exceptwheretheGroupisabletocontrolthereversalofthetemporarydifferenceanditisprobablethatthetemporarydifferencewillnotreverseintheforeseeablefuture.Thecarryingamountofdeferredtaxassetsisreviewedateachbalancesheetdateandreducedtotheextentthatit is no longer probable that sufficient taxable profitswill be available to allow all or part of the asset to berecovered.Deferredtaxiscalculatedatthetaxratesthatareexpectedtoapplyintheperiodwhentheliabilityissettledortheassetisrealised.Deferredtaxischargedorcreditedintheincomestatement,exceptwhenitrelatestoitemschargedorcrediteddirectlytoequity,inwhichcasethedeferredtaxisalsodealtwithinequity.DeferredtaxassetsandliabilitiesareoffsetwhenthereisalegallyenforceablerighttosetoffcurrenttaxassetsagainstcurrenttaxliabilitiesandwhentheyrelatetoincometaxesleviedbythesametaxationauthorityandtheGroupintendstosettleitscurrenttaxassetsandliabilitiesonanetbasis.FinancialinstrumentsRecognitionoffinancialassetsandfinancialliabilitiesFinancialassetsandfinancial liabilitiesarerecognisedontheGroup’sbalancesheetwhentheGroupbecomespartytothecontractualprovisionsoftheinstrument.DerecognitionoffinancialassetsandfinancialliabilitiesTheGroupderecognisesafinancialassetonlywhenthecontractualrightstocashflowsfromtheassetexpire,orit transfers the financialassetandsubstantiallyall therisksandrewardsofownershipof theasset toanotherentity.IftheGroupneithertransfersnorretainssubstantiallyalltherisksandrewardsofownershipandcontinuestocontrolthetransferredasset,theGrouprecognisesitsretainedinterestintheassetandanassociatedliabilityfortheamountitmayhavetopay.TheGroupderecognisesfinancialliabilitieswhentheGroup’sobligationsaredischarged,cancelledorexpired.Financialassetsa)Investments-AvailableforsalefinancialassetsAFS financial assets are non-derivatives that are not classified as loans and receivables, held-to-maturityinvestmentsorfinancialassetsatfairvaluethroughprofitorloss.TheGroup’sAFSinvestmentdoesnothaveaquotedmarketpriceinanactivemarketandtheDirectorsareoftheopinionthatfairvaluecannotbereliablybemeasured.Theinvestmentisthereforemeasuredatcost,lessanyidentifiedimpairmentloss.b)LoansandreceivablesTradeandotherreceivablesTradeandotherreceivablesaremeasuredatinitialrecognitionatfairvalue,andaresubsequentlymeasuredatamortisedcostlessanyprovisionforimpairment.
CashandcashequivalentsCashandcashequivalentscomprisecash inhandandon-demanddeposits,andothershort-termhighly liquidinvestments that are readily convertible to a known amount of cashwith threemonths or less remaining tomaturityandaresubjecttoaninsignificantriskofchangesinvalue.FinancialliabilitiesTradeandotherpayablesTradepayablesareinitiallymeasuredatfairvalue,andaresubsequentlymeasuredatamortisedcost,usingtheeffectiveinterestratemethod.ConvertibleloannotesThe component parts of compound instruments (convertible loan notes) issued by the Group are classifiedseparatelybetweentheloanandequityoptionelements.TheGrouphasoneconvertibleloannoteinissuewhichisdenominatedinacurrencydifferenttothecurrencyoftheequityoptionandaccordinglyatinceptiontheequityoptionistreatedasanembeddedderivativeandrecordedatfairvalueasafinancialliability(the“equityoption”)andthefairvalueoftheinstrumentasawholelessthevalueoftheequityoptionisrecordedasafinancialliability(the“loanelement”).Atsubsequentbalancesheetdatesthefairvalueoftheequityoptionisremeasuredwithmovementsinfairvaluebeingrecordedintheincomestatement.Theloanelementisrecordedatamortisedcostandissubjecttoanotionalinterestchargeineachreportingperiodwhichisrecordedintheincomestatement.Share-basedpaymentsTheGrouphasappliedtherequirementsofIFRS2Share-basedPaymentforallgrantsofequityinstruments.TheGroupoperates an equity-settled share optionplan to certain shareholders. The fair valueof the servicereceivedinexchangeforthegrantofoptionsandwarrantsisrecognisedasanexpense.Equity-settledshare-basedpaymentsaremeasuredatfairvalue(excludingtheeffectofnon-marketbasedvestingconditions)atthedateofgrant.Thefairvaluedeterminedatthegrantdateofequity-settledshare-basedpaymentisexpensedonagradedvesting basis over the vesting period, based on the Group’s estimate of shares that will eventually vest andadjustedfortheeffectofnon-marketbasedvestingconditions.FairvalueismeasuredbyuseoftheBlack-Scholesmodel.Theexpectedlifeusedinthemodelshasbeenadjusted,basedonmanagement’sbestestimate,fortheeffectsofnon-transferability,exerciserestrictions,andbehaviouralconsiderations.SegmentalreportingOperating segments are reported in a manner consistent with the internal reporting provided to the chiefoperatingdecisionmaker.Thechiefoperatingdecisionmaker,who is responsible forallocating resourcesandassessingperformanceoftheoperatingsegmentsandmakingstrategicdecision,hasbeenidentifiedastheBoardofDirectors.5 CriticalaccountingjudgementsandkeysourcesofestimationanduncertaintyIntheapplicationoftheGroup’saccountingpolicies,whicharedescribedinnote4,theDirectorsarerequiredtomakejudgements,estimatesandassumptionsaboutthecarryingamountsoftheassetsandliabilitiesthatarenotreadilyapparentfromothersources.Theestimatesandassociatedassumptionsarebasedonhistoricalexperienceandotherfactorsthatareconsideredtoberelevant.Actualresultsmaydifferfromtheseestimates.Theestimatesandunderlyingassumptionsarereviewedonanongoingbasis.Revisionstoaccountingestimatesarerecognisedintheperiodinwhichtheestimateisrevisediftherevisionaffectsonlythatperiodorintheperiodoftherevisionandfutureperiodsiftherevisionaffectsboththecurrentandfutureperiods.ThefollowingarethecriticaljudgementsandestimationsthattheDirectorshavemadeintheprocessofapplyingthe Group’s accounting policies and that have the most significant effect on the amounts recognised in thefinancialstatements:Convertibleloannotes(note17)Theconvertiblenoteshaveanembeddedderivativeintheformofequityconversionrights.Thefairvalueofderivativesisdeterminedbyusingappropriatevaluationtechniquesandinputstothemodel.TheGrouphasdeterminedthatitisappropriatetousetheBlack-Scholesmodeforthisoptiongiventhattheinstrumenthasbeenconvertedaftertheyearendon2March2017.Thekeyassumptionsmadeindrawingthisconclusionrelatetoforeignexchangeandtimetoexercise.Furtherdetailsaresetoutinnote17.
Share-basedpaymentsTheGrouphasanequity-settledshareoptionschemeavailabletocertainDirectorsandconsultants.Inaccordancewith IFRS2Share-basedpayment, indeterminingthe fairvalueofoptionsgranted, theGrouphasappliedtheBlack-Scholesmodel.Asaresult,theGroupmakesassumptionsforexpectedvolatilityandexpectedlife.Thefairvalueofoptionsgrantedintheyearsreportedisshowninnote24.6 BusinessandgeographicalsegmentsThroughouttheyear,theDirectorsconsidertheretobeonlyonebusinessandoperatingsegmentfromcontinuingoperations,namelyresearchanddevelopment.TheGrouphasnorevenueandthereforenogeographicalanalysisispresented.7 Exceptionalitems
Yearended
31December2016
£’000
Unaudited6May2015
to31December
2015£’000
Excessofdeemedcostoverfairvalueofassetsacquiredunderreversetakeovertransaction(Note3)
(563)
-
Legalandotherprofessionalfeesrelatingtoreversetakeovertransaction (308) - (871) - 8 OperatinglossTheoperatinglosshasbeenarrivedatafter(crediting)/charging:
Yearended31December
2016£’000
Unaudited6May2015
to31December
2015£’000
Researchanddevelopmentcosts 693 260Amortisationofintangibleassets 182 91Staffcosts(note10) 203 80Share-basedpayments(note24) 357 25Auditfees(note9) 37 -Netforeignexchange(gains)/losses (95) 1
9 Auditor’sremuneration
AmountspayabletoRSMUKAuditLLPanditsassociatesinrespectofbothauditandnon-auditservices:AmountspayabletoRSMUKAuditLLPandit’sassociates
Yearended31December
2016£’000
Unaudited6May2015
to31December
2015£’000
Auditfees FeespayabletotheGroup’sauditorforthestatutoryauditoftheGroup’sannualaccounts
29
-
Feespayabletothegroup’sauditorforthestatutoryauditofsubsidiaryundertakings
8
-
Totalauditfees 37 - Non-auditfees Taxservices 2 -Otherassuranceservices - - Totalnon-auditfees 2 -
10 Staffcosts
Theaveragemonthlynumberofemployeesandseniormanagement(includingExecutiveDirectors)was:
Yearended31December
2016£’000
Unaudited6May2015
to31December
2015£’000
Non-executiveDirectors 4 2ExecutiveDirectorsofGroupcompanies 2 - 6 2
Theaggregateremunerationcomprised:
Yearended31December
2016£’000
Unaudited6May2015
to31December
2015£’000
Salariesandconsultingfee 203 80Share-basedpayments(note24) 138 25Non-Executivedirectorsfee 52 - 393 105
Directorsremuneration(allrepresentingfees)
Yearended31December
2016£’000
Unaudited6May2015
to31December
2015£’000
JMellon(from22March2016) 8 -GBailey(from22March2016) 8 -RArmstrong(from22March2016) 26 -CWeinberg(from22March2016) 26 -IWalters(from1January2016) 220 -KShah(from22March2016) 105 - 393 -
DetailsofsharesandoptionsheldbytheDirectorsaredisclosedintheDirectors’report.
11 TaxThetaxcreditfortheyearof£31,000(2015:£15,000)relatesentirelytothereleaseofdeferredtaxliabilitiesinrespectofintangibleassets.ThetaxassessedfortheyearisatthestandardrateofcorporationtaxintheIsleofManof0%(2015:0%)andiscalculatedasfollows:
Yearended31December
2016£’000
Unaudited6May2015
to31December
2015£’000
Lossonordinaryactivitiesbeforetax (2,476) (481) Lossonordinaryactivitiesbythestandardrateoftax - -Foreigntax - -Releaseofdeferredtaxrelatedtosubsidiariesoperatinginotherjurisdictions (31) (15)
Taxcreditfortheyear (31) (15) TheCompany’ssubsidiary,iOXTherapeuticsltd(“IOX”)issubjecttotaxintheUK.Thereisnotaxchargeforthereportingperiodsduetolosses.
IOXhaspotentialresearchanddevelopmentcashcreditsofapproximately£244,000consistingof£53,000for2015and£191,000for2016.ThecreditswillberecognisedwhentheyareacceptedbytheUKtaxauthorities,giventhatthesearethefirstclaimsmadebythecompany.DeferredTaxationAsat31December2016,iOxtaxlosseswereapproximately£1,045,000(2015:£54,000).Taxlosseswillbecarriedforward and are potentially available for utilisation against taxable profits in future years. The Group has notrecognisedadeferredtaxassetinrespectofthesetaxlossesasthereisinsufficientevidenceofsuitablefutureprofitbeingavailableagainstwhich these lossescanbeoffset.Theassetwillbe recognised in futureperiodswhen itsrecovery(againstappropriatetaxableprofits)isconsideredprobable.At31December2016theGrouphadadeferredtaxliabilityof£201,000(2015:£232,000)recognisedinrespectofintangibleassetsarisingontheacquisitionofiOx.TheintangibleassetrelatestoinprocessresearchresidingintheUKandthereforedeferredtaxhasbeenrecordedat17%beingtherateapplicableinthatcountry.TheGrouphasnootherprovidedorunprovideddeferredtaxliabilities.Thereductionintheliabilityintheyearof£31,000(2015:£15,000)hasbeenrecordedinfullintheincomestatement
12 LossperOrdinaryShare
Basic lossperOrdinaryShare iscalculatedbydividingthenet loss for theyearattributabletoOrdinaryequityholders of the parent by theweighted average number of Ordinary Shares outstanding during the year. ThecalculationofthebasicanddilutedlossperOrdinaryShareisbasedonthefollowingdata:
Theweightedaveragenumberofsharesisadjustedfortheimpactofthereverseacquisitionasfollows:
• Priortothereversetakeover,thenumberofsharesisbasedonSalvaRxLimited,adjustedusingtheshareexchangeratioarisingonthereversetakeover;and
• Fromthedateofthereversetakeover,thenumberofshareisbasedontheCompany.
DilutivelossperOrdinaryShareequalsbasiclossperOrdinaryShareas,duetothelossesincurredin2016and2015,thereisnodilutiveeffectfromthesubsistingshareoptions.
13 Investments
2016£’000
Unaudited2015£’000
Available-for-saleinvestmentsInvestmentinIntensity(i)
1,395
-
Loanreceivableatamortisedcost RIFTloan(ii) 36 - 1,431 - (i) On 22 April 2016, the Company acquired 1million Series A preferred stock in Intensity Therapeutics Inc., a
Delawarecorporation(“Intensity”)forUS$2mincash.AllSeriesAPreferredstockisconvertibleintoequalnumberofcommonsharesinIntensity.TheCompany’sholdingsrepresentlessthan10%oftheequityofIntensity.
13 Investments(continued)
(ii)On13December2016,SalvaRxLimited,awhollyownedsubsidiaryoftheCompany,investedUS$45,000incash
inconvertiblepromissorynote issuedbyRiftBiotherapeutics Inc.,aDelawarecorporation (“Rift”). TheNotecarriesinterestat5%andmaturesontheearliestof31December2017andachangeincontrolatRift.SalvaRx
Yearended31December
2016£’000
Unaudited6May2015
to31December
2015£’000
LossesLossforthepurposesofbasiclosspersharebeingnetlossattributabletoequityholdersoftheparent
2,038
326 NumberWeightedaveragenumberofOrdinarySharesforthepurposesofbasiclosspershare
Number
34,561,950
Number
27,883,852 2016
£2015
£LossperOrdinaryShare Basicanddiluted,pencepershare (0.06p) (0.01p)
Limitedmadefurther investments intoRiftsubsequenttothebalancesheetdateandagreedtoconvert intoequityinRiftasexplainedinnote27(a).
Asat31December2016,theCompanyhasdeterminedthattherewasnoevidenceofanyimpairmentinthecarryingvalueofinvestmentsandasaresultnoadjustmentwasconsiderednecessaryinitscarryingvalue.14 Intangibleassets Inprocess
research£’000
Cost At6May2015 -Additions 1,457 At31December2015and2016 1,457 Amortisation At1January2016 -Chargefortheyear (91) At31December2015 (91) Chargefortheyear (182) At31December2016 (273) Carryingamounts At6May2015 - At31December2015 1,366 At31December2016 1,184 On1July2015,SalvaRxacquired15,313newSeedPreferredSharesiniOxatapriceof£120perSeedPreferredShare,whichrepresents60.49%.equityiniOxfor£1,837,560.ExceptforapreferenceoverOrdinarySharesonwindingup,SeedPreferredShareshavethesamevotingrightsasOrdinarySharesandareconvertibleintoequalnumberofordinaryshares.SalvaRxhasamajorityequityinterestandalsohassignificantcontroloverthemanagementofiOx.Asaresult,managementhaveconcludedthatiOxisasubsidiaryundertakingandthesefinancialstatementsincluderesultsofoperationsforiOxfortheyearended31December2016andassetsandliabilitiesasat31December2016andcomparativefiguresincluderesultsofoperationsforIOXfrom1July2015to31December2015andassetsandliabilitiesasatDecember2015.14 Intangibleassets(continued)Thenon-controllinginterestiniOxonthedateofacquisitionwasvaluedat£1.2million,basedontheir39.51%equitybeingvaluedonthebasisofthepriceSalvaRxpaidfor60.49%equityiniOx.Asat1July2015,netassetsacquiredweredeterminedasperIFRS3–businesscombinations,asfollows: £’000 £’000 Intangibleassets 1,458Othernetassets Liabilityassumed (10) Assetsassumed* 1,838
1,828Deferredtaxliability(note11) (248) Netassetsacquired 3,038 Allocatedto Cashconsiderationpaidforcompany’sinterest 1,838Non-controllinginterest(39.51%)** 1,200 3,038 *ConsiderationwaspaidfornewSeedPreferredSharesiniOx.AsSalvaRxhascontroloveriOxandtheconsiderationpaidbySalvaRxwillremainwithintheGroup,thenetcashimpactoftheacquisitionontheGroupis£nil.**Non-controllinginteresthasbeenvaluedbasedon39.51percent.ofthegrossedupconsiderationpaidbySalvaRx((£1,837,560/60.49percent.)x39.51percent.)Aspartofthisbusinesscombination,andalsoon1July2015,iOxTherapeuticsLimited(“iOx”)enteredintoanInvestmentAgreementwithTheUniversityofOxford, ISIS, theLudwig Institute,SalvaRxLimitedandProfessorCerundolo. As part of this agreement, iOx also entered into a Clinical Trials Sponsorship agreementwith TheUniversityofOxfordandalsoentered intoa licenceagreementwiththeLudwig Institutetoaccess intellectualpropertyrightsandknow-howrelatingtocellagonists.Accordingly,theDirectorshavedeterminedthattheexcessofconsiderationoveridentifiableassetsandliabilitiesrelatesentirelytoanin-processresearchintangibleasset.Theintangibleassetthusarisingisbeingamortisedover8years,beingtheDirectorsassessmentoftheperiodoverwhichthetechnologiesarelikelytobedevelopedandattheendofwhichcommercialproductswillhopefullybeavailable for sale. The remaining life of the intangible asset is 6.5 years. Given that the progress of iOx issatisfactory,thereisnoindicationofimpairment.
15 Tradeandotherreceivables
2016£’000
Unaudited2015£’000
VATrecoverable 5 6Prepaymentsandotherreceivables 29 230 34 236 16 Cashandcashequivalents
Cash and cash equivalents as at 31 December 2016 of approximately £1.0million (As at 31 December 2015(unaudited):£0.6million)comprisecashheldbytheGroup.
17 ConvertibleLoanNotes
2016£’000
Unaudited2015£’000
Convertibleloannotes
(616)
-
Equityoptiononconvertibleloan (78) - (694) - On21April 2016, the Company issuedUS$1million of zero coupon convertible unsecured loan notes (“LoanNotes”)toJimMellon,theNon-ExecutiveChairmanandGregBailey,aNon-ExecutiveDirector(“theNoteholders”),whoarebothsubstantialshareholdersintheCompany.MrMellonandDrBaileysubscribedforUS$0.5millionofLoanNoteseach.TheLoanNoteshaveatermofthreeyears,withazerocouponandmaybeconvertedinwholeorinpartattheNoteholder’sdiscretionatapriceof35.5pperordinaryshare.TheNoteholdershaveundertakennot toconvert their LoanNotes incircumstanceswhere (i) theconversionwould result in theConcertParty’s
holdingintheCompanyexceeding74.66%onafullydilutedbasisor(ii)thepercentageofsharesinpublichandswouldfallbelow10%.On2March2017,TheNote liabilitywastransferredtoSalvaRxLimitedandthenoteholdersagreedtoaccept4,000sharesofSalvaRxLimitedatapriceof$250pershareinsettlementoftheloannotes,whichwouldgivethem5.85%equityinSalvaRxLimited.Therecognitionofthisinvestment,andthemovementstothebalancesheetdate,canbesummarisedasfollows: EquityOption
£’000Loan£’000
Onissue–21April2016(Credit)/chargetofinanceincomeMovementinfairvalueNotionalinterest
211
(133)-
484-
46Foreignexchangeloss - 86 At31December2016 78 616 ThesenoteshaveanembeddedderivativeintheformoftheequityconversionrightswhosevaluewasdefinedduetotheconversionintoSalvaRxLimitedsharessubsequenttothebalancesheetdateasexplainedabove.ThefairvalueofthederivativehasbeenestimatedusingaBlack-Scholespricingmodelwiththefollowingassumptions: 21April
201631December
2016Riskfreeinterestrate 1% 1%Expecteddividend Nil NilExpectedvolatility 102.75% 102.75%Expectedlife 315days 61daysMarketprice £0.32 £0.31
TheCompanyhasthereforedeterminedthefairvalueofthederivativeatthebalancesheetdatetobe£78,094.Thedifferenceinderivativevaluefromthepreviousvalueof£211,267atthedateofinceptionhasbeencreditedtotheincomestatementasafinancingcost.TheDirectorshavevaluedtheoptionusingtheBlackScholesmodel.IndeterminingthevaluationtheDirectorshaveassumed:
• Anoptionlifeconsistentwiththeactualexercisedateof2March2017reflectingtheiroriginalassessmentoftimetoexercise,and
• SpotFXrateatbothmeasurementdate.Inmakingthisassumption,theDirectorshaveconsideredtheimpactonthevaluationofareasonablerangeofpossibleexchangeratesandnotedthattheimpactonvaluationisreasonablysmall.
Thevalueoftheoptionatissuehasbeendeductedfromtheoverallfairvalueoftheconvertibleloannoteandisaccountedforseparatelyonthebalancesheet.ItwillbesubjecttorevaluationoneachbalancesheetdatethroughtheincomestatementinaccordancewithIAS39.Theresidualloanbalanceof£484,000atinceptionisheldatamortisedcostandissubjecttoanotionalinterestat12.83%,whichfortheyearto31December2016was£46,000.Theinterestamountisexpensedasfinancecostandincludedwithintheloanbalance.Theloanbalanceissubjecttorevaluationatthespotexchangerate.18 Tradeandotherpayables
2016£’000
Unaudited2015£’000
Tradepayables 224 244Accruals 71 - 295 244
Tradepayablesandaccrualsprincipallycompriseamountsoutstandingfortradepurchasesandon-goingcosts.The average credit period taken for trade purchases is 40 days (2015: 31 days). The Group has financial riskmanagementpoliciestoensurethatallpayablesarepaidwithinthecredittimeframe.TheDirectorsconsiderthatthecarryingamountoftradeandotherpayablesapproximatestotheirfairvalue.Nointerestisgenerallychargedonbalancesoutstanding.19 FinancialinstrumentsCapitalriskmanagementTheGroupmanagesitscapitalresourcessoastoensurethatentitiesintheGroupwillbeabletocontinueasagoingconcern,whilemaximisingthereturntoshareholders.Untilitachievespositivecash-flow,theGroupexpectstofunditsoperationsthroughacombinationofequitycapitalraisedfromthemarketand,whereappropriate,debtfinance.ThecapitalresourcesoftheGroupconsistofcashandcashequivalentsarisingfromequityattributabletoequityholdersoftheparent,comprisingissuedcapital,reservesandretainedearningsasdisclosedintheConsolidatedStatementofChangesinEquity.ExternallyimposedcapitalrequirementTheGroupisnotsubjecttoexternallyimposedcapitalrequirements.Categoriesoffinancialinstruments
2016£’000
Unaudited2015£’000
Financialassets:AvailableforsaleInvestments
1,395
-
Financialassets:LoansandReceivables InvestmentsCashandcashequivalents
36967
-567
Tradeandotherreceivables - 215 2,398 782 Financialliabilities:Atamortisedcost
Tradeandotherpayables 295 244Convertibleloannotes 616 - FinancialLiabilities:Atfairvaluethroughprofitorloss Equityoptiononconvertibleloan 78 - 989 244
FinancialriskmanagementobjectivesManagementprovidesservicestothebusiness,co-ordinatesaccesstodomesticandinternationalfinancialmarkets,andmonitorsandmanagesthefinancialrisksrelatingtotheoperationsoftheGroup.Theserisksincludeforeigncurrencyrisk,creditriskandliquidityrisk.TheGroupdoesnotenterintoortradefinancialinstruments,includingderivativefinancialinstruments,forspeculativepurposesandanycurrencyhedgingtransactions.Inordertoeffectivelymanagetheserisks,theBoardofDirectorshasapprovedstrategiesforthemanagementoffinancialrisks,whichareinlinewithcorporateobjectives.ThesestrategiessetupguidelinesfortheshorttermandlongtermobjectivesandactiontobetakeninordertomanagethefinancialrisksthattheGroupfaces.Themajorguidelinesarethefollowing:
• Maximise the use of “natural hedge” favouring asmuch as possible the natural off-setting of costs,
payablesandreceivablesdenominatedinthesamecurrency.• AllfinancialriskmanagementactivitiesarecarriedoutandmonitoredcentrallevelanddiscussedatBoard
level.• TheGroupwillnotinvesttemporaryexcessliquidityinsharesorsimilarinstrumentsunlessauthorisedby
theBoardofDirectors.ForeignexchangeriskandforeigncurrencyriskmanagementTheGroupisexposedtocurrencyrisksinceitsmainsourceoffundingisinBritishpoundswhileasignificantpartofitsexpensesareinUSdollars.WhiletheGroupaimstominimiseexposuretoforeignexchangeriskbymatchingthecurrencyofincomeandrelatedexpenditureflowswherepossible,fluctuationsintheexchangeratebetweenthesetwocurrenciescanhavesignificanteffect.Financialassetsbycurrency:
Investments
Tradeand
otherreceivable
Cashand
cashequivalent
Total
£’000 £’000 £’000 £’000Currency Britishpounds - - 729 729USdollars 1,431 - 238 1,669 Balanceat31December2016 1,431 - 967 2,398 Currency Britishpounds - 215 567 782USdollars - - - - Balanceat31December2015 - 215 567 782 Financialliabilitiesbycurrency:
Borrowings
Tradeand
otherpayables
Total £’000 £’000 £’000Currency Britishpounds - 78 78USdollars 694 217 911 Balanceat31December2016 694 295 989 Currency Britishpounds - 134 134USdollars - 110 110 Balanceat31December2015 - 244 244
SensitivityanalysisA10%increase/decreaseinexchangerateoftheBritishPoundagainsttheUSDwouldreduce/increasethelossaftertaxby£67,300.
CreditriskmanagementCreditriskreferstotheriskthatacounterpartywilldefaultonitscontractualobligations,resultinginfinanciallosstotheGroup.TheGrouphasminimaltradeandotherreceivablesattheyearend.TheGroupmakesallowancesforimpairmentofreceivableswherethereisanidentifiedeventwhich,basedonpreviousexperience,isevidenceofareductionintherecoverabilityofcashflows.The credit risk on liquid funds (cash) is considered to be limited because the counterparties are financialinstitutions with good credit ratings assigned by international credit-rating agencies. The carrying amount offinancialassetsrecordedinthefinancialstatementsrepresentstheGroup’smaximumexposuretocreditrisk.Therearenosignificantconcentrationsofcreditrisk.Thecredit riskarising in respectof investments is inevitablyhigher risk.Thenatureof theGroup’sbusiness isdeveloping innovative solutions for the treatment of cancer and there is no guarantee that any individualinvestmentwillbesuccessful.ThisriskispartlymitigatedthroughrepresentationonitsBoardofDirectorsandtheGroup’sCEOmonitorsitsprogressonaregularbasis.ThemaximumcreditrisktowhichtheGroupisexposedissummarisedinthefollowingtable.
2016£’000
Unaudited2015£’000
Investments 1,431 -Cashandcashequivalents
967 567
Tradeandotherreceivables - 215 Balanceat31December 2,398 782
Asexplainedinnote16,cashandcashequivalentsbalancesrepresentbankbalances.TheGroupdoesnotholdcollateralforanyofitsreceivables.Therewerenopastduereceivables.InvestmentsareintheformofequityinvestmentinprivatecompaniesinwhichtheGroupisrepresentedonitsBoardofDirectorsandtheGroup’sCEOmonitorsitsprogressonaregularbasis.LiquidityriskmanagementUltimate responsibility for liquidity risk management rests with the Board of Directors, which has built anappropriateliquidityriskmanagementframeworkforthemanagementoftheGroup’sshort,mediumandlong-termfundingandliquiditymanagementrequirements.TheGroupmanagesliquidityriskbymaintainingadequatecashreservesandbycontinuouslymonitoringforecastandactualcashflows.AllfinancialliabilitiesheldbytheGrouparenon-interestbearing.Thefollowingtablesanalysefinancialliabilitiesbyremainingcontractualmaturity.Financialliabilitiesbycontractualmaturity
Convertibleloannote
Tradeandother
payables
Total £’000 £’000 £’000 Lessthan1year - 295 2951–3years 694 - 694
Balanceat31December2016 694 295 989 Lessthan1year - 244 2441–3years - - - Balanceat31December2015 - 244 244
With the exception of the convertible loan note, the Group expects to pay all liabilities at their contractualmaturity.Asdescribedinnote27(c),theconvertibleloannotewasconvertedintoequityshortlyaftertheyearend.However,asabiotechcompanyatanearlystageofdevelopmentandwithoutsignificantinternallygeneratedcashflows,thereareinherentliquidityrisks,includingthepossibilitythatadditionalfinancingmaynotbeavailabletotheCompany,orthatactualdrugdevelopmentexpendituresmayexceedthoseplanned.Thecurrentuncertaintyin global markets could have an impact on the Company’s future ability to access capital on terms that areacceptabletotheCompany.TherecanbenoassurancethatrequiredfinancingwillbeavailabletotheCompany.20 SharecapitalAuthorisedandissuedequitysharecapital
2016Unaudited
2015
Number’000
£’000
Number’000
£’000
Authorised OrdinarySharesof2.5peach(2015:0.025p) 80,000 2,000 1,040,000 260 Issuedandfullypaid OrdinarySharesof2.5peach(2015:0.025p) 36,467 911 618,493 155 TheCompanyhasoneclassofOrdinaryShares,whichcarrynorighttofixedincome.Movementsduringtheyear:
Yearended31December2016
Unaudited6May2015
to31December2015
Number’000
£’000
Number’000
£’000
Balanceatbeginningofyear 618,493 155 618,493 155Shareconsolidation (612,308) - - -Issuedduringtheyearforcash 5,493 136 - -Issuedonreverseacquisition(note3) 24,789 620 - - Issuedandfullypaid OrdinarySharesof2.5peach 36,467 911 618,493 155 InMarch2016,theCompanycompletedashareconsolidationonthebasisof1newOrdinaryShareforevery100OrdinaryShares.
InMarch2016,theCompanyraisedapproximately£1.9millionbeforeexpensesinaprivateplacementinvolvingissuanceof5,492,958ordinarysharesatapriceof35.5ppershare.InMarch2016, theCompany issued24,788,732 sharesatamarketpriceof35.5p inexchange fora88.9%ofSalvaRxLimited.Thisresultedinthereversetakeoverdescribedinnote3.21 Equity,purchaseofownsharesInSeptember2015,theCompanysubscribed£215,000toacquire11.1%oftheissuedsharecapitalofSalvaRx.InMarch2016,TheCompanyacquired the remaining issuedsharecapitalofSalvaRx throughshareexchange,whichwasconsideredareversetakeovertransactionasexplainedinNote3.Asaresult,theexistinginvestmentof£215,000hasbeentransferredtoequityandtreatedasapurchaseofownshares.22 Sharepremium £’000 At6May2015andat31December2015 52,533IssueofOrdinarySharesinaprivateplacement(note20) 1,813IssueofOrdinarySharesinareversetakeovertransaction(note3) 8,180CostsdirectlyrelatedtoissueofOrdinaryShares (173) -------------CancellationofSharePremiumaccount
62,353(62,353)
At31December2016 -
The shareholders of the Company in theirmeeting of 4 August 2016 approved the cancellation of the sharepremiumaccount.WhilstthisgaverisetodistributablereservesfortheCompany,inthesefinancialstatementsthecreditentryisrecordedinthereverseacquisitionreserve.
23 Reverseacquisitionreserve
£’000 At6May2015¹ (52,688)CapitalofSalvaRxtransferredtoreverseacquisitionreserve² 940
At31December2015 (51,748)IssueofequitybyCompany(netofcosts)³ (1,776)Reverseacquisition4 (5,764)Sharepremiumcancellation(note22)5 62,353 At31December2016 3,065
ThemovementsontheReverseacquisitionreserveareasfollows:
1) TheseconsolidatedfinancialstatementspresentthelegalcapitalstructureoftheCompany.However,underreverseacquisitionaccountingrules,theCompanywasnotacquireduntil21March2016andthereforetheentryaboveisrequiredtoeliminatetheinitialequityoftheCompany.
2) SalvaRxLimitedwasincorporatedon6May2015andonthisdateissuedsharecapitalofequivalentto£940,000.Asthesefinancialstatementspresentthecapitalstructureoftheparententity,theissueofequitybySalvaRxLimitedhasbeenrecordedinthisreserve.
3) Immediatelypriortothereverseacquisition,theCompanyraised£1,776,000throughaplacing(netofcostsof£173,000).AstheCompanywasnotpartoftheconsolidatedSalvarRxLimitedgroupatthattime,theaboveentryisrequiredtoeliminatethebalancesheetimpactofthistransaction.
4) Thereverseacquisitionaccountingisdescribedindetailinnote3.TheentryaboverepresentsthedifferencebetweenthevalueoftheequityissuedbytheCompany,andthedeemedconsiderationgivenbySalvaRxLimitedtoacquiretheCompany.
5) Asdescribedinnote22,theCompanycancelledtheSharePremiumaccountatthe2016AGM.WhistthisgivesrisetodistributablereservesoftheCompany,itisnotdistributablewithintheseconsolidatedfinancialstatementsandthereforethecreditentryhasbeenrecordedwithinthisreserve.
24 Share-basedpaymentreserves
Shareoptionsoutstandingareasfollows:
SalvaRxGroupplc 2016 2015
Options’000
Weightedaverageexerciseprice£
Options’000
Weightedaverageexerciseprice£
Outstandingat1January/6May 474 23.2p - Grantedduringtheyear 2,752 37.9p 474 23.2p Outstandingat31December 3,226 35.74p 474 23.2p
iOxTherapeuticsLimited 2016 2015
Options
’000
Weightedaverageexerciseprice£
Options’000
Weightedaverageexerciseprice£
Outstandingat1January/6May
0.7
120
-
-
Grantedduringtheyear 0.6 120 0.7 120 Outstandingat31December 1.3 120 0.7 120
24 Share-basedpaymentreserves(continued)
The Company and its subsidiary do not operate a formal stock option scheme, however certain options tosubscribefortheCompany’soritssubsidiary’sshareshavebeengrantedtoselectedDirectorsandconsultantsonanadhocbasispursuanttoindividualoptionagreements(the‘Non-PlanOptions’).
(A)iOxTherapeuticsLtdDetailsoftheOptionsareasfollows:Dateofgrant
Dateofexpiry
Exerciseprice£
Vestingterms
#ofOptions
Valuebasedon
Black-Scholesoptionpricingmodel£’000
Gradedvestingin2016£’000
Gradedvestingin
2015£’000
14-Dec-15 14-Dec-20 120 25%ongrantand25%eachanniversary 675 57
23 25
28-Nov-16 28-Nov-21 120 vested 649 60 60 -
1,324 117
83 25
(B)TheCompany
Dateofgrant
Dateofexpiry
Exerciseprice£
Vestingterms
#ofOptions
Valuebasedon
Black-Scholesoptionpricingmodel£’000
Gradedvestingin2016£’000
Gradedvestingin
2015£’000
April2015toJuly2015
16-Feb-21 0.232 vested 431,153* -- -
16-Feb-15 16-Feb-18 0.232 vested 43,115* - - -
22-Mar-16 22-Mar-21 0.355
Threeequaltranches-1ston22March2017,2ndon22March2018and3rdon22March
2019
2,508,777 509
233 -
22-Mar-16 22-Mar-21 0.71 vested 182,333 31 31 -22-Mar-16 22-Mar-19 0.355 vested 60,563 10 10 -
3,225,941 550
274 -
*TheseoptionsintheCompanyvestedinfullpriortothereversetakeoverandaccordinglythereisnosharebasedpaymentchargefortheseoptionsinthesefinancialstatements.
24 Share-basedpaymentreserves(continued)
TheaboveOptionsinclude519OptionsiniOxand1,320,704OptionsintheCompanygrantedtothedirectors.
ThefairvalueoftheoptionshasbeencalculatedusingtheBlackScholesmodel.ThesignificantinputsintothemodelfortheIFRS2valuationwereasfollows:
Grants 14
December2015
28November
2016
22March
2016
22March
2016 #ofOptions 675 649 2,691,110 60,563Riskfreeinterestrate 1% 1% 1% 1%Expectedvolatility 91.60% 106.48% 92.91% 94.33%Expectedlifeindays 1,850 1,825 1,825 1,095Marketprice £120 £120 £0.30 £0.30
25 Relatedpartytransactions
Transactions between the Company and its subsidiary, which are related parties, have been eliminated onconsolidationandarenotdisclosedinthisnote.
Paymentstokeymanagementpersonnel
TheremunerationoftheNon-ExecutiveDirectors,ExecutiveDirectorsandseniormanagement,whoarethekeymanagementpersonneloftheGroup,issetoutbelowinaggregateforeachofthecategoriesspecifiedinIAS24RelatedPartyDisclosures.
Yearended31December
2016£’000
Unaudited6May2015
to31December
2015£’000
Salaryandconsultingfee 203 80Sharebasedpayments 138 25Non-Executivedirectorsfee 52 - 393 105
26 Non-controllinginterest
TheCompany’smaterialnon-controllinginterests(“NCI”)at31December2016and2015wereassociatedwithTherapeuticsLimited(“iOx”) inwhichtheNCI is39.51%.Therewerenodividendspaidby iOxduring2016and2015.
ThemovementintheNCIisasfollows:
£’000At6May2015 -Onacquisition 1,194LossattributabletoNCI (140)
At31December2015 1,054LossattributabletoNCI (407) At31December2016 647
Summarisedfinancial informationbasedonthoseamountsincludedintheseconsolidatedfinancialstatementsforiOxisasfollows:
Statementoffinancialposition:
Yearended31December
2016£’000
Unaudited6May2015
to31December
2015£’000
Currentassets 263 412Currentliabilities (217) (172) Netassets 47 240
Statementofcomprehensiveloss:
Yearended31December
2016£’000
Unaudited6May2015
to31December
2015£’000
Researchanddevelopment (815) (260)Otheroperatingcosts (63) (20) Netlossandcomprehensiveloss (878) (280)
26 Non-controllinginterest(continued)
Statementofcashflows:
Yearended31December
2016£’000
Unaudited6May2015
to31December
2015£’000
Cashflowsusedforoperations (566) (105)Cashflowsfromfinancingactivities 430 510 Net(decrease)/increaseincashandcashequivalent (147) 405
27 Eventsafterthebalancesheetdate
a. On9February2017,SalvaRxLimitedadvancedafurtherUS$45,000andon16March2016,SalvaRxLimitedannouncedaninvestmentofUS$1millioninRIFTBiotechnologiesInc.Total investmentofUS$1,090,000inRIFTistobeconvertedintoanequityofapproximately30%inRIFT.
b. On28February2017,SalvaRxLimitedagreedtoinvest€300,000convertibleloaninNekonalSARLtoparticipateinthefundingofitsauto-immuneprogramsanda€300,000equityinvestmentinNekonalOncologyInc.,whichwillbeajointventurebetweenSalvaRxLimitedandNekonalSARL.
c. On2March2017, theCompany announced that its investment in Intensity Therapeutics Inc. andConvertiblenotesofUS$1millionwere transferred toSalvaRxLimited.Theconvertible loannoteswere converted into shares of SalvaRx Limited at a price of US$250 a share, thus reducing theCompany’sinterestinSalvaRxLimitedto94.2%.
d. On2March2017, theCompanyalsoannouncedanofferingbySalvaRxLimitedofunsecured loannotesofuptoUS$5million,carryingcouponof7%andrepayableinfouryears.TheholdersoftheloanwillbeissuedUS$7,500ofWarrantinrespectofeachUS$10,000ofloannotes.TheWarrantswillvestintheeventofaqualifyingtransactionandareexercisableatapriceofthehigherofUS$250pershareandapricereflectingdiscounttotheimpliedvaluationofSalvaRxLimited.SalvaRxLimitedhassofarraisedUS$3millioninunsecuredloannotes.