Brainstorm Cell Therapeutics Inc. (BCLI) Corporate MidYear Update on NurOwn Program (Transcript)

BrainstormCellTherapeuticsInc.(NASDAQ:BCLI)CorporateMid-YearUpdateonNurOwnProgramJuly8,20248:00AMET CompanyParticipants JoyceLonergan-LifeSciAdvisors ChaimLebovits-PresidentandChiefExecutiveOfficer HaroHartounian-ExecutiveVicePresident,ChiefOperatingOfficerBobDagher-ExecutiveVicePresident,ChiefMedicalOfficer ConferenceCallParticipants JasonMcCarthy-MaximGroup DavidBautz-ZachsSmallCapResearch Operator GreetingsandwelcometotheBrainstormCellTherapeuticsMid-Year2024ConferenceCall.Atthistime,allparticipantsareinalisten-onlymode.Asareminder,thiscallisbeingrecorded. AndIwouldnowliketointroduceyourhostfortoday'scall,JoyceLonerganofLifeSciAdvisors.Ms.Lonergan,youmaybegin. JoyceLonergan Thankyou,Holly.Goodmorning,andthankyouforjoiningustoday.Beforepassingthecallofftocompanymanagementforpreparedremarks,Iwouldliketoremindlistenersthatthisconferencecallwillcontainnumerousstatements,descriptions,forecasts,andprojectionsregardingBrainstormCellTherapeuticsanditspotentialforfuturebusinessoperationsandperformance.StatementsregardingthemarketpotentialforthetreatmentofneurodegenerativedisorderssuchasALS;thesufficiencyofthecompany'sexistingcapitalresourcesforcontinuingoperationsin2024andbeyond;thesafetyandclinicalefficacyoftheNurOwntechnologyplatform;clinicaltrialsofNurOwnandrelatedclinicaldevelopmentprograms;andthecompany'sabilitytodevelopstrategiccollaborationsandpartnershipstosupporttheirbusinessplanningefforts. Forward-lookingstatementsaresubjecttonumerousrisksanduncertainties,manyofwhicharebeyond BrainstormÂ’scontrol,includingtherisksanduncertaintiesdescribedfromtime-to-timeinitsSECfilings.Thecompany'sresultsmaydiffermateriallyfromthoseprojectedontoday'scall.Thecompanyundertakesnoobligationtopubliclyupdateanyforward-lookingstatements. JoiningusonthecalltodaywillbeChaimLebovits,PresidentandCEOofBrainstorm;Dr.HaroHartounian,ChiefOperatingOfficer;Dr.BobDagher,ChiefMedicalOfficerisalsoonthelineandwillbeavailableforQ&A. IwouldnowliketoturnthecallovertoMr.Lebovits,pleasegoahead. ChaimLebovits Thankyou,Joyce.Thankyoutoallofyouwhohavejoinedusthismorning.IwouldliketoupdateyouonanumberofpositiverecentdevelopmentsforBrainstormandourNurOwnDevelopmentProgram. OurpriorityistoinitiatethePhase3btrialinALS.OnJune24,wehadaface-to-faceTypeCmeetingwiththeFDAtodiscussthechemistry,manufacturing,andcontrolsaspectsofthePhase3trial.IampleasedtosaythatthiswasaconstructivemeetingandthatwearenowalignedwiththeagencyonresolvingpreviouslyoutstandingCMCquestionsraised.TheFDAcontinuestobesupportiveandwearegratefulfortheirinputandadvice. Asyoumayknow,CMCisalwayspartofanFDAreviewprocess.However,itrequiresspecialconsiderationforanycelltherapyproduct,includingNurOwn.Theseproductshaveadditionalcomplexities,andinthemanufacturingprocess,it'simportantthattheFDAisinvolvedatvariousstepsduringtheregulatoryprocess,includingpriortoinitiatingatrial.Thisin-personTypeCmeetingfollowstheSPAagreementgrantedbythe FDA,whichweannouncedinApril.TheSPAoutlinesimportantdetailsoftheplannedPhase3btrial,includingitsoverallobjectives,design,endpoints,statisticalanalysis,andothersupportiveclinicaltrialdocuments. Assumingthetrialmeetsexpectations,theagreementensuresthatthedatawillbeacceptedbytheFDAasacentralpartofaBLAforNurOwn. WehaverecentlysignedacontractwithaleadingClinicalResearchOrganizationorCROtosupporttheinitiationandexecutionofthePhase3btrial.ThisCROisinternationallyrecognizedforitsexpertiseinALSandinmanagingcomplexclinicaltrials,includinginthefieldofcelltherapy.Theywillprovideuswitha comprehensiveandfullrangeofservicestofullyexecuteonallaspectsofthetrialwiththehighestqualityandspeed.They'vealreadylinedupanumberofclinicalsitesforthestudyandareworkingonallprojectplans, systems,andcontactsinordertoproceedwithdozingourfirstpatient,hopefullybeforetheendoftheyear. Wealsoannouncedlastweekthatweenteredintoatransactionwithasingleinstitutionalinvestorforthesaleofcommonstockandwarrants,raisinggrossproceedsof$4million.Wearemindfulofourbalancesheetandwanttomakesurethecompanyisfundedappropriately.Thisamountwillnot,ofcourse,besufficienttofundthe entirePhase2bstudy,butit'sexpectedtotakeusthroughimportantnear-termmilestones.Wecontinuetoexploreotherfinancingoptions,includingnon-dilutivegrants,aswehavedoneinthepast. TheotherimportantrecentdevelopmentwasourappointmentofDr.HaroHartounianasourChiefOperatingOfficer.Harobringsadistinguishedtrackrecordwithover32-yearsofexperienceinthebiopharmaceuticalindustrywithaparticularfocusoncellandgenetherapy.Harohasbeensuccessfulatachievinggoalsatlargebiopharmaceuticalcompanies,contractdevelopmentandmanufacturingorganizations,aswellasstartupbiotechnologycompanies.Hiscareerhighlightsincludefoundingabiocentric,astate-of-the-artcellandgenetherapyCDMOfacility,andheledthatcompanythroughasuccessfulacquisitionin2022. Inhisnewrole,Dr.HartounianwilloverseealloperationalaspectsofBrainstorm,includingCMCandcommercialization.We'rehonoredtohavehimjointhecompanyatthismoment,andhewillhavetheopportunitytosayafewintroductorywordsonthecalltoday. Insummary,weareexcitedtomoveforwa