Infant Bacterial Therapeutics AB (publ), (IBT) Interim...

Press Release 19 August 2016

Infant Bacterial Therapeutics AB (“IBT”) is a pharmaceutical company based in Stockholm that develops drugs that meet the needs of the premature infant. IBT’s current focus is on clinical development of IBP-

9414, a drug candidate containing Lactobacillus reuteri, in the prevention of necrotizing enterocolitis (“NEC”), a fatal disease that affects premature infants. IBT is listed on Nasdaq First North with Erik

Penser Bank as Certified Adviser. www.ibtherapeutics.com

Infant Bacterial Therapeutics AB (publ), (IBT) Interim report January 1 – June 30 2016 Message from the CEO “In June we announced that the first premature infant had been enrolled and dosed in the Company´s Phase ll clinical trial. This Phase ll trial is a randomized, double blind, parallel group, dose escalation, placebo-controlled multicenter study to investigate the safety and tolerability of IBP-9414 administered in preterm infants. The multicenter trial is being conducted in a number of neonatal intensive care units in the US and will enroll 120 premature infants in total. The first planned independent Data Safety Monitoring Board (DSMB) evaluation of safety data was performed on August 12th. The DSMB concluded that there were no objections to dose escalation based on the information provided to the DSMB. We are very pleased that the trial has begun and is progressing according to plan. This is another major milestone in the development of a new pharmaceutical for this very sensitive group of patients.” Staffan Strömberg, Chief Executive Officer Financial summary

SEK 000’s 2016 Jan-Jun

2015 Jan-Jun

Net sales

- - Net profit/loss

-16 078 -9 673

Result after tax

-16 284 -9 680 Total assets

133 127 15 917

Cash flow for the period

71 973 463 Cash

116 384 1 517

Earnings per share, weighted average, before and after dilution (SEK)

-6,4 -5,4

Equity per share (SEK)

23,1 207,0 Equity ratio (%)

95% 65%

Press Release 19 August 2016

Infant Bacterial Therapeutics AB (“IBT”) is a pharmaceutical company based in Stockholm that develops drugs that meet the needs of the premature infant. IBT’s current focus is on clinical development of IBP-

9414, a drug candidate containing Lactobacillus reuteri, in the prevention of necrotizing enterocolitis (“NEC”), a fatal disease that affects premature infants. IBT is listed on Nasdaq First North with Erik

Penser Bank as Certified Adviser. www.ibtherapeutics.com

Significant events during the first six months • The Annual General Meeting decided on 8 February on repayment of conditional shareholder

contributions by offsetting previously received group contributions by SEK 20.6m • BioGaia AB (publ) distributed its entire holding (94.5 % of shares and 96 % of votes) in IBT to

BioGaia’s shareholders • IBT’s shares were listed on Nasdaq First North • IBT completed a guaranteed share issue which generated approximately SEK 89m after deduction

of issue costs • The first premature infant has been enrolled and dosed in the Company’s Phase ll clinical trial

Significant events after the reporting period • There were no significant events after the reporting period prior to the date of publication of this

interim report For additional information please contact Staffan Strömberg, CEO, phone: +46 8 410 145 55 Peter Rothschild, Chairman of the Board, phone: +46 8 410 145 55 Infant Bacterial Therapeutics AB Bryggargatan 10 111 21 Stockholm Phone: +46 8 410 145 55 [email protected] Publication The information in this Interim Report is such which IBT is obliged to make public pursuant to the EU Market Abuse Regulation and which is to be made public according to the Nasdaq regulations for companies listed on Nasdaq First North. The information was submitted for publication, by the CEO stated above, at 08.00 a.m. CET on 19 August, 2016.

Infant Bacterial Therapeutics (publ) Interim Report January-June 2016

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InterimReport January1–June30,2016Significanteventsduringthefirstsixmonths• TheAnnualGeneralMeetingdecidedon8Februaryonrepaymentofconditionalshareholder

contributionsbyoffsettingpreviouslyreceivedgroupcontributionsbySEK20.6m• BioGaiaAB(publ)distributeditsentireholding(94.5%ofsharesand96%ofvotes)inIBTto

BioGaia’sshareholders• IBT’sshareswerelistedonNasdaqFirstNorth• IBTcompletedaguaranteedshareissuewhichgeneratedapproximatelySEK89mafterdeductionof

issuecosts• ThefirstprematureinfantshavebeenenrolledanddosedintheCompany’sphasellclinicaltrial

Significanteventsafterthereportingperiod• Therewerenosignificanteventsafterthereportingperiodpriortothedateofpublicationofthis

interimreport

Financialsummary SEK000’s 2016

Jan-Jun2015

Jan-Jun2015

Jan-Dec

Netsales

- - -

Netprofit/loss

-16078 -9673 -20615Resultaftertax

-16284 -9680 -23

Totalassets

133127 15917 82543Cashflowfortheperiod

71973 463 43357

Cash

116384 1517 44411

Earningspershare,weightedaverage,beforeandafterdilution(SEK)

-6,4 -5,4 0,0

Equitypershare(SEK)

23,1 207,0 831,2

Equityratio(%)

95% 65% 91%

IBTinbriefInfantBacterialTherapeuticsAB(IBT)isapublicCompanydomiciledinStockholm.TheCompany’sB-sharesaretradedonNasdaqFirstNorthinStockholm(IBTB)since29March,2016.IBTisapharmaceuticalcompanywithavisiontodevelopdrugstotreatrarediseasesaffectingprematureinfants.Currently,IBT’sfocusisondevelopingadrug,IBP-9414,usingLactobacillusreuteritopreventnecrotizingenterocolitis(”NEC”),afataldiseasethataffectsprematureinfants.


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MessagefromtheCEOThreeyearshavepassedsinceI,togetherwithBioGaiaandHeadofResearchandDevelopment,EamonnConnolly,commencedtheoperationsofIBTasasubsidiarytoBioGaia.Wearepursuingademandingyetexcitingdevelopmentandgrowthplaninthecompany,aimingatdevelopingadrugforprematureinfants.Ourcurrentfocusistopreventoneoftheleadingcausesofdeathamongprematureinfants,theintestinalillnessnecrotizingenterocolitis(NEC).ThetechnologicalplatformofouroperationsisbasedonthebacterialspeciesthatBioGaiahassuccessfullyworkedwiththroughoutseveraldecades.Thankstothefantasticeffortofallcolleagues,wereceived,attheendoflastyear,notificationfromtheAmericanFoodandDrugAdministration(FDA)thatourInvestigationalNewDrug(IND)applicationhadbecomeeffectiveandthatwecouldproceedwithclinicaltrialsintheUS.Concurrently,theSwedishMedicalProductsAgency(Sw.Lakemedelsverket)gaveuspermissiontoproceedwithclinicaltrialsinSwedenonprematureinfants,themostvulnerableindividualsimaginable.ThiswasamajormilestoneforIBT.Ourintentionistosuccessfullycompletetheforthcomingclinicaltrialsinanumberofclinicsandhospitalsin,primarily,theUSandthereafterreceiveallnecessarymarketapprovalsforthedrug.Alldrugdevelopmentrequiressignificantcapital,andourprojectisnoexception.TheshareissueinMayprovidedthecapitalnecessarytofundthefirstclinicaltrial.Afuturecommercializationoftheproductcanbecompletedinseveraldifferentways:bylicensingtheproduct,bysellingtherightsoftheprojectorbyusbringingtheproducttothemarket.InJuneweannouncedthatthefirstprematureinfanthadbeenenrolledanddosedintheCompany´sPhasellclinicaltrial.ThisPhaselltrialisarandomized,doubleblind,parallelgroup,doseescalation,placebo-controlledmulticenterstudytoinvestigatethesafetyandtolerabilityofIBP-9414administeredinpreterminfants.ThemulticentertrialisbeingconductedinanumberofneonatalintensivecareunitsintheUSandwillenroll120prematureinfantsintotal.ThefirstplannedindependentDataSafetyMonitoringBoard(DSMB)evaluationofsafetydatawasperformedonAugust12th.TheDSMBconcludedthattherewerenoobjectionstodoseescalationbasedontheinformationprovidedtotheDSMB.Weareverypleasedthatthetrialhasbegunandisprogressingaccordingtoplan.Thisisanothermajormilestoneinthedevelopmentofanewpharmaceuticalforthisverysensitivegroupofpatients.Wehaveagreatdealofworkaheadofus,butIamconfidentthatwehavethecapacityandcompetencenecessarytocompletethetasksuccessfully.IamproudandhappythatIBTsinceMarchisalistedcompany,andmyhopeisthatallshareholderswanttojoinusonourexcitingjourney.Ialsohopethatwecanattractnewownersandlicensingpartnerswhoseethepotentialintheproject.Itisoftheutmostimportancethatwehaveourshareholders’confidenceinordertosecurefuturecapitalneeds,whichwillbenecessarytocompleteourambitionsofprovidingthemarketwithadrugthatsavesthelivesofprematureinfants.StaffanStromberg,ChiefExecutiveOfficer


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DescriptionofIBT’sdevelopmentprojectIBP-9414IBThasdevelopedtheproductionprocessfordrugcandidateIBP-9414whichisacomplexprocessinvolvingmanystepsincludingfermentation,purificationandlyophilizationtoobtainthefinalproduct.Therisksforimpuritiesareidentified,minimizedandcontrolled.IBTintendstoconductaclinicalprogramconsistingoftwoclinicaltrials.ThefirststudyisaphaseIIsafetyandtolerabilitystudyfortwodifferentdoselevelsofIBP-9414in120prematureinfantsintotalwithbirth-weightrangingfrom500to2,000g.ThestudywasinitiatedinMay,2016.TheaimistoassessthesafetyandtolerabilityofthedrugcandidateIBP-9414administeredinprematureinfants.TheincidenceofNECwillalsobeobserved.ThebudgetforthefirstclinicalstudyisapproximatelySEK45million.Resultsfromtheongoingphasellclinicaltrialareexpectedduringthefourthquarterof2017.ThesubsequentphaseIIIpivotalstudywillbedesignedtodemonstrateanddocumentefficacyofIBP-9414overplacebointhepreventionofNECinpreterminfantswithabirth-weight≤1,500g.Thisstudywillalsoincludesafetyevaluationinthelargercohort.Giventheurgencytoprovideaneffectivepreventativetherapytothisunmetmedicalneed,IBTplanstoutilizetheavailableFDAandEMAexpeditedprogramstoreachthemarketassoonaspossible. History2013• InfantBacterialTherapeuticsAB(IBT)commenceditsactivitiesandstartedthedevelopmentofa

preventivetherapy(IBP-9414)againstNECusingLactobacillusreuteri• IBTisgrantedOrphanDrugDesignationbytheFDAforLactobacillusreuteriforthepreventionofNEC

inprematureinfants• U.S.FoodandDrugAdministration(FDA)providesscientificinputforIBT’sdevelopmentplans

2014• PharmaceuticaldevelopmentdefiningtheformulationandmanufacturingprocessforIBP-9414• TheEuropeanMedicinesAgencyprovidesscientificinputforIBT’sdevelopmentplans

2015• IBP-9414isgrantedOrphanDrugDesignationbytheEuropeanCommissionforLactobacillusreuteri

forthepreventionofNECinprematureinfants• ProductionofdrugcandidateIBP-9414accordingtoallapplicablepharmaceuticalchemistry-

manufacture-controlregulationsforclinicalphaseIItrial• IBTreceivedapprovalfromtheSwedishMedicalProductsAgencytoconductaclinicaltrialinSweden

2016

• BioGaiadistributesitssharesinIBTtoBioGaia’sshareholders• TheCompany’ssharesarelistedonNasdaqFirstNorth• IBTreceivesRarePediatricDiseaseDesignationfromFDAforIBP-9414• IBTcompletedashareissuewhichgeneratedapproximatelySEK89m• AllBoardmembers,theCEOandHeadofResearchandDevelopmentsubscribedtosharesinthe

CompanyintheRightsIssuecompletedinMay,2016• IBTannouncedthatthefirstprematureinfanthasbeenenrolledanddosedintheCompany’sphasell

clinicaltrialintheUSA


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Risksanduncertaintiesinsummary

ThevalueoftheCompanyislargelydependentonsuccessintheCompany’sdevelopmentofIBP-9414andthesuccessfulcompletionofclinicaltrialsandthegrantofmarketingauthorizationbytheUSFoodandDrugAdministration(”FDA”)and/ortheEuropeanMedicinesAgency(”EMA”).IBT’sclinicaldevelopmentisatanearlystageandthereisariskthatIBP-9414willnotdemonstratetherequiredeffect.IfthedevelopmentonIBP-9414isunsuccessful,IBTmaytrytofocusonotherprojectsbutthereisariskthatsuchprojectswillnotbesuccessful.

InadditiontothecompletedShareIssueinMay,2016,therewillbesignificantcapitalneedsforfurtherclinicaltrials.TheCompanyhasnotgeneratedanyrevenue,whichmeansthatIBTwillrequireaccesstocapitalinthefuturebeforeitscashflowturnspositive.AccesstocapitalmaybelimitedattimeswhenneededbytheCompany.TheCompanyestimates,basedonitscurrentdevelopmentplan,thatadditionalcapitalofSEK300mto600mwillberequiredforthedevelopmentofIBP-9414andsubmissionforregulatoryapproval.

ApredominantshareofIBT’sdevelopmentcostsarecommitmentsinforeigncurrencies.ShouldtheSEKdepreciateinvalueversusthespecificcurrency,itcouldhaveasignificantimpactontheCompany’sfinancialpositionandresults.

FurtherinformationonrisksanduncertaintiesisavailableinIBT’sRightsIssueProspectusontheCompany’shomepagewww.ibtherapeutics.com

Relatedpartytransactions

TheCompanywasasubsidiaryofBioGaiaAB(publ)until23March,2016.TherewerenosignificantrelatedpartytransactionswithBioGaiauntil23March,2016.BioGaiaissuedasubscriptionguaranteeintheRightsIssueinMay,2016,forwhichtheCompanypaidaguaranteefeeinJune2016amountingtoapproximatelySEK1.3m.Norelatedpartytransactionshaveoccurred.

Financialcalendar

Year–endReport2016:14February2017

AnnualReport2016:April2017

CertifiedAdviser

TheCompany’sCertifiedAdviserisErikPenserBank,tel.+4684638000

Contactpersons

StaffanStromberg,CEO,telephone:+46841014555PeterRothschild,Chairman,telephone:+46841014555

ContactinformationInfantBacterialTherapeuticsAB(Reg.no.556873-8586)Bryggargatan1011121Stockholm,SwedenTelephone:[email protected]


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PublicationTheinformationinthisInterimReportissuchwhichIBTisobligedtomakepublicpursuanttotheEUMarketAbuseRegulationandwhichistobemadepublicaccordingtotheNasdaqregulationsforcompanieslistedonNasdaqFirstNorth.Theinformationwassubmittedforpublication,bytheCEOstatedabove,at08.00a.m.CETon19August,2016.Financialdevelopment–commentstodevelopmentduringthefirsthalfyear2016AmountsarereportedinKSEK(SEKinthousands).Amountsinparenthesisrefertothesameperiodinthepreviousyearunlessstatedotherwise.CostsOperationalcostsamountedto16078(9673)KSEKofwhichcostsfortheongoingIBP-9414clinicaltrialamountedto10009(4582)KSEK.Personnelcostsamountedto3326(3334)KSEK.Otherexternalcostsamountedto2743(1757)KSEK.ShareissuecostsamountedtoSEK11,0(0,0)mwhichwaschargedtoshareholdersequity.ResultandfinancialpositionOperational result amounted to -16078(-9673)KSEKandresultafterfinancialitemsamountedto-16284(-9680)KSEK.Resultaftertaxamountedto-16284(-9680)KSEK.Resultpershareamountedto-6,35(-5,39)SEK.Cashflowfortheperiodamountedto71973(463)KSEK.Thecashflowincludedashareissueamountingto89123(0,0)KSEK.TheCompany’scashbalanceon30June,2016,amountedto116384comparedto44411KSEKon31December,2015.TheCompany’sshareholdersequityon30June,2016,amountedto127048comparedto74809KSEKon31December,2015.Shareholdersequitypershareamountedto23,08comparedto831,21SEKon31December,2015.TheCompany’sequityratioamountedto95comparedto91%on31December,2015.PersonnelTheaveragenumberofemployeesduringthefirsthalfyearamountedtofour(four)persons.SharesThetotalnumberofsharesonJanuaryI,2016,amountedto90000.Theshareswerespliton12February,2016,afterwhichthetotalnumberofsharesamountedto1834546(calculationofresultpershareisrestatedasifaveragenumberofsharesweresplitonJanuary1,2015).Atotalnumberof3669092sharewereissuedinanewshareissueinMay,2016.On30June,2016,totalnumberofsharesamountedto5503638ofwhich222198classA-sharescarryingtenvotesand5281440classB–sharescarryingonevote.IBT’sclassB–sharewaslistedonNasdaqFirstNorthon29March,2016.Board’sassurance

TheBoardofDirectorsandCEOherebycertifythatthehalf-yearinterimreportgivesatrueandfairpresentationoftheCompany’soperations,financialpositionandresultofoperations,anddescribesmaterialrisksanduncertaintiesfacingtheCompany.

Stockholm,19August,2016

PeterRothschild JanAnnwall AndersEkblom MargaretaHagman StaffanStrömbergChairman Director Director Director CEO

ThisinterimreporthasnotbeensubjecttoreviewbytheCompany’sauditors.

Nb:ThisisatranslationoftheSwedishinterimhalf-yearreport.Ifanydiscrepanciesexist,theSwedishversionshallprevail.


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Condensedincomestatement

SEK000 2016

Jan-Jun2015

Jan-Jun2015

jan-dec

Netsales - - -

Revenue 0 0 0 Sellingexpenses 0 0 -2600

Researchanddevelopmentexpenses -16078 -9673 -17974

Otheroperatingexpenses -41

Operatingloss -16078 -9673 -20615 Resultfromfinancialitems

Interestincomeandsimilarprofit/lossitems 0 0 0

Interestexpenseandsimilarprofit/lossitems -206 -7 -9

Resultafterfinancialitems -16284 -9680 -20624 Appropriations

Groupcontribution 0 0 20601

Resultbeforetaxes -16284 -9680 -23

Tax 0 0 0

Resultfortheperiod -16284 -9680 -23

Resultpershare

SEK

Resultpershare,beforeandafterdilution*

-6,35 -5,39 -0,01

Numberofshares,weightedaverage* 2564310 1794546 1806382

Numberofsharesatendofperiod** 5503638 50000 90000

*Weightedaverage2015restatedduetosplit2016.Nodilutioneffectsexist

**Onjune30,2016,allocationofemittedsharesamountedto222198A-sharescarrying10votespershareand5281440B-sharescarrying1votepershare


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Condensedbalancesheet

SEK000 30Jun2016 30jun2015 31Dec2015 ASSETS

Non-currentassets Intangiblenon-currentassets

Activateddevelopmentexpenses 16225 13775 16225

Totalnon-currentassets 16225 13775 16225

CurrentassetsCurrentreceivables

Receivablefromparentcompany 0 0 20420Otherreceivables 464 519 535Prepaidexpensesandaccruedincome 54 106 952

Totalcurrentassets 518 625 21907Cashandcashequivalents 116384 1517 44411

Totalcurrentassets 116902 2142 66318

TOTALASSETS 133127 15917 82543

EQUITYANDLIABILITIESEquity

Restrictedequity Sharecapital 1500 50 500

Unrestrictedequity Sharepremiumreserve 140473 0 52350

Accumulatedlosses 1359 19981 21981Netlossfortheperiod -16284 -9680 -22

Totalequity 127048 10351 74809

LiabilitiesCurrentliabilities

Accountspayable 269 1356 518Othercurrentliabilities 187 193 137Accruedexpensesandprepaidincome 5623 4017 7079

Totalcurrentliabilities 6079 5566 7734Totalliabilities 6079 5566 7734

TOTALEQUITYANDLIABILITIES 133127 15917 82543


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Condensedstatementofcashflows

SEK000 2016

Jan-Jun2016

Jan-Jun2015

Jan-Dec Operatingactivities

Operatingprofit/loss -16078 -9673 -20615Financialitems,net -206 -7 -9

Cashflowfromoperatingactivitiesbeforechangesinworkingcapital -16284 -9680 -20624

CashflowfromchangesinworkingcapitalIncrease(-)/Decrease(+)inoperatingreceivables 789 6715 -628

Increase(+)/Decrease(-)inoperatingliabilities -1655 2128 4228

Cashflowfromoperatingactivities -17150 -837 -17024

Investmentactivities Acquisitionofimmaterialassets -7700 -10150

Financingactivities Conditionalshareholdercontributions 9000 11000

Groupcontribution

6731

Shareissue 89123 0 52800

Cashflowfromfinancingactivities 89123 9000 70531

71973 463 43357Cashflowfortheperiod

Cashandcashequivalentsatthebeginningoftheyear 44411 1054 1054

CASHANDCASHEQUIVALENTSATTHEENDOFTHEPERIOD 116384 1517 44411

Condensedstatementofchangesinequity

SEK000

Restrictedequity Unrestrictedequity

Sharecapital Sharepremiumreserve

Accumulatedlossesincl.lossfor

theperiod

Totalequity

Openingequityat1Jan2015 50 0 10981 11031Shareholdercontribution 9000 9000Netlossfortheperiod -9680 -9680Closingequityat30Jun2015 50 0 10301 10351 Openingequityat1Jul2015 50 0 10301 10351Shareholdercontribution

2000 2000

Shareissue 40 52760 52800Bonusissue 410 -410 0Netlossfortheperiod

-10943 -10943

Groupcontribution 20601 20601Closingequityat31Dec2015 500 52350 21959 74809 Openingequityat1Jan2016 500 52350 21959 74809Repaymentofshareholdercontribution -20600 -20600Shareissue 1000 99166 0 100166Shareissuecosts -11043 0 -11043Netprofit/lossfortheyear -16284 -16284Closingequityat30Jun2016 1500 140473 -14925 127048


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Accountingprinciples

TheinterimreporthasbeenissuedinaccordancewiththeAnnualAccountsAct(Årsredovisningslagen)andregulationsapplicabletocompanieslistedonNasdaqFirstNorth.

IBTappliestheAnnualAccountsActandgeneralrecommendationsBFNAR2012:1Årsredovisningochkoncernredovisning(K3)byBokföringsnämnden.

TheCompany’saccountingprinciplesaredescribedinitslatestpublishedAnnualReport(2015).ThesameaccountingprinciplesandcalculationmethodsusedintheAnnualReportwereappliedintheinterimreport.

AmountsarereportedinKSEK(SEKinthousands).Amountsinparenthesisrefertothesameperiodinthepreviousyearunlessstatedotherwise.

FinancialdefinitionsNumberofshares:Numberofsharesattheendoftheperiod

TotalAssets:Totalassetsattheendoftheperiod

Shareholdersequity/share:Totalshareholdersequitydividedbythenumberofsharesattheendoftheperiod

Averagenumberofshares:Averagenumberofsharesduringthereportingperiod(splitin2016restatedfor

comparativefigures)

Netsales:Salesfortheperiod

Reportingperiod:Firsthalfyear2016

Resultpershare:Resultfortheperioddividedbyaveragenumberofshares

Equityratio:Totalshareholdersequityasapercentageoftotalassets

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