Offering Statement for ZENII, LLC (“Intrommune Therapeutics”) · product commercialization,...
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Paul Riss: Jeanne Rockman: Jonathan Mason: Offering Statement for ZENII, LLC (“Intrommune Therapeutics”) This document is generated by a website that is operated by Netcapital Systems, LLC ("Netcapital"), which is not a registered broker-dealer. Netcapital does not give investment advice, endorsement, analysis or recommendations with respect to any securities. All securities listed here are being offered by, and all information included in this document are the responsibility of, the applicable issuer of such securities. Netcapital has not taken any steps to verify the adequacy, accuracy or completeness of any information. Neither Netcapital nor any of its officers, directors, agents and employees makes any warranty, express or implied, of any kind whatsoever related to the adequacy, accuracy or completeness of any information in this document or the use of information in this document. All Regulation CF offerings are conducted through Netcapital Funding Portal Inc. ("Portal"), an affiliate of Netcapital, and a FINRA/SEC registered funding-portal. For inquiries related to Regulation CF securities activity, contact Netcapital Funding Portal Inc.: [email protected] All non-Regulation CF securities-related activity on netcapital.com, including, but not limited to private placement offerings under Regulation D and A, are conducted by Livingston Securities, LLC ("Livingston"), a non-affiliate of Netcapital, and a registered broker-dealer, and member FINRA/SIPC, located at 626 RexCorp Plaza, 6th floor, West Tower, Uniondale, NY 11556. For inquiries related to non- Regulation CF securities activity, contact Livingston Securities: [email protected] [email protected] Netcapital, Portal and Livingston do not make investment recommendations and no communication, through this website or in any other medium, should be construed as a recommendation for any security offered on or off this investment platform. Equity crowdfunding investments in private placements, Regulation A, D and CF offerings, and start-up investments in particular are speculative and involve a high degree of risk and those investors who cannot afford to lose their entire investment should not invest in start-ups. Companies seeking startup investments through equity crowdfunding tend to be in earlier stages of development and their business model, products and services may not yet be fully developed, operational or tested in the public marketplace. There is no guarantee that the stated valuation and other terms are accurate or in agreement with the market or industry valuations. Additionally, investors may receive illiquid and/or restricted stock that may be subject to holding period requirements and/or liquidity concerns. In the most sensible investment strategy for start-up investing, start-ups should only be part of your overall investment portfolio. Further, the start-up portion of your portfolio may include a balanced portfolio of different start-ups. Investments in startups are highly illiquid and those investors who cannot hold an investment for the long term (at least 5-7 years) should not invest. The information contained herein includes forward-looking statements. These statements relate to future events or to future financial performance, and involve known and unknown risks, uncertainties, and other factors, that may cause actual results to be materially different from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties, and other factors, which are, in some cases, beyond the company’s control and which could, and likely will, materially affect actual results, levels of activity, performance, or achievements. Any forward-looking statement reflects the current views with respect to future events and is subject to these and other risks, uncertainties, and assumptions relating to operations, results of operations, growth strategy, and liquidity. No obligation exists to publicly update or revise these forward- looking statements for any reason, or to update the reasons actual results could differ materially from
Transcript of Offering Statement for ZENII, LLC (“Intrommune Therapeutics”) · product commercialization,...
PaulRiss:
JeanneRockman:
JonathanMason:
OfferingStatementforZENII,LLC(“IntrommuneTherapeutics”)ThisdocumentisgeneratedbyawebsitethatisoperatedbyNetcapitalSystems,LLC("Netcapital"),whichisnotaregisteredbroker-dealer.Netcapitaldoesnotgiveinvestmentadvice,endorsement,analysisorrecommendationswithrespecttoanysecurities.Allsecuritieslistedherearebeingofferedby,andallinformationincludedinthisdocumentaretheresponsibilityof,theapplicableissuerofsuchsecurities.Netcapitalhasnottakenanystepstoverifytheadequacy,accuracyorcompletenessofanyinformation.NeitherNetcapitalnoranyofitsofficers,directors,agentsandemployeesmakesanywarranty,expressorimplied,ofanykindwhatsoeverrelatedtotheadequacy,accuracyorcompletenessofanyinformationinthisdocumentortheuseofinformationinthisdocument.
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Netcapital,PortalandLivingstondonotmakeinvestmentrecommendationsandnocommunication,throughthiswebsiteorinanyothermedium,shouldbeconstruedasarecommendationforanysecurityofferedonoroffthisinvestmentplatform.Equitycrowdfundinginvestmentsinprivateplacements,RegulationA,DandCFofferings,andstart-upinvestmentsinparticulararespeculativeandinvolveahighdegreeofriskandthoseinvestorswhocannotaffordtolosetheirentireinvestmentshouldnotinvestinstart-ups.Companiesseekingstartupinvestmentsthroughequitycrowdfundingtendtobeinearlierstagesofdevelopmentandtheirbusinessmodel,productsandservicesmaynotyetbefullydeveloped,operationalortestedinthepublicmarketplace.Thereisnoguaranteethatthestatedvaluationandothertermsareaccurateorinagreementwiththemarketorindustryvaluations.Additionally,investorsmayreceiveilliquidand/orrestrictedstockthatmaybesubjecttoholdingperiodrequirementsand/orliquidityconcerns.Inthemostsensibleinvestmentstrategyforstart-upinvesting,start-upsshouldonlybepartofyouroverallinvestmentportfolio.Further,thestart-upportionofyourportfoliomayincludeabalancedportfolioofdifferentstart-ups.Investmentsinstartupsarehighlyilliquidandthoseinvestorswhocannotholdaninvestmentforthelongterm(atleast5-7years)shouldnotinvest.
Theinformationcontainedhereinincludesforward-lookingstatements.Thesestatementsrelatetofutureeventsortofuturefinancialperformance,andinvolveknownandunknownrisks,uncertainties,andotherfactors,thatmaycauseactualresultstobemateriallydifferentfromanyfutureresults,levelsofactivity,performance,orachievementsexpressedorimpliedbytheseforward-lookingstatements.Youshouldnotplaceunduerelianceonforward-lookingstatementssincetheyinvolveknownandunknownrisks,uncertainties,andotherfactors,whichare,insomecases,beyondthecompany’scontrolandwhichcould,andlikelywill,materiallyaffectactualresults,levelsofactivity,performance,orachievements.Anyforward-lookingstatementreflectsthecurrentviewswithrespecttofutureeventsandissubjecttotheseandotherrisks,uncertainties,andassumptionsrelatingtooperations,resultsofoperations,growthstrategy,andliquidity.Noobligationexiststopubliclyupdateorrevisetheseforward-lookingstatementsforanyreason,ortoupdatethereasonsactualresultscoulddiffermateriallyfrom
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TheCompany
1. Whatisthenameoftheissuer?
ZENII,LLC
Eligibility
2. ThefollowingaretrueforZENII,LLC:
Organizedunder,andsubjectto,thelawsofaStateorterritoryoftheUnitedStatesortheDistrictofColumbia.
NotsubjecttotherequirementtofilereportspursuanttoSection13orSection15(d)oftheSecuritiesExchangeActof1934.
NotaninvestmentcompanyregisteredorrequiredtoberegisteredundertheInvestmentCompanyActof1940.
NotineligibletorelyonthisexemptionunderSection4(a)(6)oftheSecuritiesActasaresultofadisqualificationspecifiedinRule503(a)ofRegulationCrowdfunding.(Formoreinformationaboutthesedisqualifications,seeQuestion30ofthisQuestionandAnswerformat).
HasfiledwiththeCommissionandprovidedtoinvestors,totheextentrequired,theongoingannualreportsrequiredbyRegulationCrowdfundingduringthetwoyearsimmediatelyprecedingthefilingofthisofferingstatement(orforsuchshorterperiodthattheissuerwasrequiredtofilesuchreports).
Notadevelopmentstagecompanythat(a)hasnospecificbusinessplanor(b)hasindicatedthatitsbusinessplanistoengageinamergeroracquisitionwithanunidentifiedcompanyorcompanies.
3. HastheissueroranyofitspredecessorspreviouslyfailedtocomplywiththeongoingreportingrequirementsofRule202ofRegulationCrowdfunding?
No.
Directors,OfficersandPromotersoftheCompany
4. Thefollowingindividuals(orentities)representthecompanyasadirector,officerorpromoteroftheoffering:
MichaelNelson
MichaelNelsonhasbeentheFounderorCo-FounderandChiefExecutiveOfficerorChiefFinancialOfficerofseveralearlystagehealthcarecompanies.Mr.NelsonhasservedasChiefExecutiveOfficerofIntrommuneTherapueticssinceDecember2013.Mr.NelsonhasservedtheChiefFinancialOfficerofImmunovent,LLC,acompanydevelopinganovelallergydiagnostic,sinceFebruary2013,andasChiefFinancialOfficerofAllovate,LLC,fromwhichIntrommuneislicensingitsfoodallergyoralmucosalimmunotherapyplatform,sinceFebruary2012.Mr.NelsonisaperiodicadvisortoWestwoodCapital,LLCwithover20yearsofinvestmentbanking,legal,managementandinvesting
experience.Mr.Nelsonhasbeeninvolvedasanadvisororinvestorwithmergersandacquisitions,initialandsubsequentpublicofferingsofcommonstock,preferredstock,contingentvaluerights,andseniorandsubordinateddebt.Hehasrepresentedandadvisedbothdebtorsandcreditorsofanumberofdistressedcompanies,bothinsideandoutsideofbankruptcy.Mr.NelsonwasanAssociateDirectoratBarclaysCapital,wherehehelpedmanagea$2billionproprietaryportfoliofocusedonspecialsituations,includingriskarbitrage,andthehealthcaresector.Mr.NelsonwasalsoVicePresidentatINGCapitalLLC,wherehehelpedmanagea$400millionportfolio.Mr.NelsonwasaninvestmentbankerinthehealthcareinvestmentbankinggroupatCIBCWorldMarkets,wherehespecializedinhealthcareservicesandinformationandpharmaceuticaltechnologyforprivateandpublicofferingsandM&A.Inthisrolehemanagedtheexecutionofsuchtransactionsandraisedacombinedtotalinexcessof$325millionforseveralcompaniesinthehealthcaresector.Mr.NelsonbeganhiscareerasanattorneywiththelawfirmofWillkieFarr&GallagherintheBankruptcy&BusinessReorganizationdepartmentspecializingindebtorandcreditorrepresentationandstructuredfinancecounselinginthesecuritizationandstructuredfinancearea.Mr.NelsonalsopracticedlawasaseniorassociatewithDeweyBallantine.Mr.NelsonreceivedaB.S.inBiologyfromCornellUniversityandaJ.D.fromNewYorkUniversitySchoolofLaw.HeworksandisadmittedtopracticeinNewYork.
ErickBerglund
ThroughouthisprofessionalcareerDr.Berglundhashadastronginterestindevelopinglifesciencestechnologiestosolvehumanhealthcareproblemsandtomeetunmetmedicalneeds.Since2012hehasbeeninvolvedwithnucleatingandgrowingacommercialframeworktodeveloporalmucosalimmunotherapy(OMIT)fortreatingvariousallergicdiseases.IntrommuneTherapeuticsisakeypartofthisframeworkthatfocussesonOMITtreatmentofpeanutandotherfoodallergies.SinceAugust2013,Dr.BerglundhasservedastheChiefScientificOfficerofIntrommuneTherapuetics.FromFebruary2013toOctober2015,Dr.BerglundservedastheChiefExecutiveOfficerofImmunovent,LLC,acompanydevelopinganovelallergydiagnostic,andsinceFebruary2012hehasservedastheChiefExecutiveOfficerofAllovate,LLC,fromwhichIntrommuneislicensingitsfoodallergyoralmucosalimmunotherapyplatform.FromJuly2011untilAugust2013,Dr.BerglundworkedforH4B,astand-alonemedicalcommunicationsfirm.Dr.BerglundreceivedhisscientifictrainingasaPhDstudentintheBiochemistryDepartmentoftheJohann-Wolfgang-GoetheUniversitätinFrankfurt,Germany.HisthesisworkwascarriedoutasanexternaldoctoralcandidatewhileworkinginthecommercialR&DlaboratoriesofHoechstMarionRoussel(nowSanofi)inFrankfurt.HisthesisworkinvolvedthedevelopmentofaninvitrosystemforidentifyingcompoundsthatactdirectlyatthelevelofDNAtranscription.Priortothat,heearnedhisMSdegreeinBiochemistryfromBostonUniversityMedicalSchoolresearchingtheregulatorymechanismofcelldifferentiationandcell-specificgeneexpression.Asaco-founderandCSOofIntrommune,Dr.Berglundhasbeendirectlyinvolvedwithstrategiclicensing,partnering,anddevelopmentoftherelevantpatentportfolio.PriortoworkingonIntrommuneTherapeutics,Dr.Berglundheldaseriesofcorporatepositionswithlifesciencecompaniesthat,together,requireddevelopmentofabroadrangeofskillsrangingfrombiotechnologypatentstrategy,fosteringdevelopmentpartnerships,andstrategicmedicalcommunication.SincebeginningworkwiththeOMITplatformfortreatingallergicdisorders,Dr.Berglundhascometoappreciatetheenormousunmethealthcareneedsinthisarea,particularlyforfoodallergies.
AnthonyRobinson
Mr.Robinsonhasspent25yearsinthelifesciencesincluding:healthcare,medical,pharmaceutical,biotech,andconsultingservicesexecutingclinicalandbusinessoperations,productdevelopment,productcommercialization,sales,businessdevelopment,finance,andcorporatedevelopment.SinceJanuary2015,Mr.RobinsonhasservedastheChiefOperatingOfficerofIntrommuneTherapeutics.PriortoestablishingBarclayConsultingLLCin2014,Mr.RobinsonworkedwithinResearchandDevelopmentatShire,2006-2014andCovanceInc.,2001-2006.Mr.RobinsonhasaMaster’sinSciencefromMCPHahnemann(DrexelUniversity),aMaster’sinBusinessAdministrationfromPennsylvaniaStateUniversity,andaBachelor’sinSciencefromCornellUniversity.
MichaelNelsonSecurities:
Class:
VotingPower:
ErickBerglundSecurities:
Class:
VotingPower:
PrincipalSecurityHolders
5. Providethenameandownershiplevelofeachperson,asofthemostrecentpracticabledate,whoisthebeneficialownerof20percentormoreoftheissuer’soutstandingvotingequitysecurities,calculatedonthebasisofvotingpower.Tocalculatetotalvotingpower,includeallsecuritiesforwhichthepersondirectlyorindirectlyhasorsharesthevotingpower,whichincludesthepowertovoteortodirectthevotingofsuchsecurities.Ifthepersonhastherighttoacquirevotingpowerofsuchsecuritieswithin60days,includingthroughtheexerciseofanyoption,warrantorright,theconversionofasecurity,orotherarrangement,orifsecuritiesareheldbyamemberofthefamily,throughcorporationsorpartnerships,orotherwiseinamannerthatwouldallowapersontodirectorcontrolthevotingofthesecurities(orshareinsuchdirectionorcontrol—as,forexample,aco-trustee)theyshouldbeincludedasbeing“beneficiallyowned.”Youshouldincludeanexplanationofthesecircumstancesinafootnotetothe“NumberofandClassofSecuritiesNowHeld.”Tocalculateoutstandingvotingequitysecurities,assumealloutstandingoptionsareexercisedandalloutstandingconvertiblesecuritiesconverted.
5,040,600
ClassAMembershipUnits
33.6%
4,040,700
ClassAMembershipUnits
26.9%
BusinessandAnticipatedBusinessPlan
6. Describeindetailthebusinessoftheissuerandtheanticipatedbusinessplanoftheissuer.
IntrommuneTherapeuticsisdevelopinganoveltherapeuticplatformfortreatingfoodallergy.Thetherapyworkssimultaneouslyasusersbrushtheirteethwithaspecializedtoothpaste,calledoralmucosalimmunotherapy(OMIT).TheleadproductcandidateisINT-301forpeanutallergy,whichaddressesanunmetmedicalneedformillionsofpeopleworldwide(includingupwardsof3millionAmericans)withapotentiallydeadlyallergytopeanut.INT-301willallowuserstoseamlesslyintegratedisease-modifyingtreatmentforpeanutallergyintotheireverydayroutine.Withlong-termconsistentuseoftheproduct,itisexpectedthatpeoplewithpeanutallergywillfundamentallydecreasetheirsensitivitytopeanutandbeabletolivefreefromtheconstantfearofseriousallergicreactions.IntrommuneispursuingastraightFDA-approvalpathwayforINT-301forpeanutallergy,followedbyproductdevelopmentforseveralotherkeyfoodallergies.OnceapprovedbytheFDA,itisexpectedthatinsurancepayorswillcoverthecostoftherapytofoodallergysufferers.Duringthedevelopmentphase,severalsignificantvalueinflectionsareexpected,openingthedoortoexitsandmonetizationsthatarecommoninthepharmafield,includingco-developmentandpartnership,acquisition,andIPO.
RiskFactors
Acrowdfundinginvestmentinvolvesrisk.Youshouldnotinvestanyfundsinthisofferingunlessyoucanaffordtoloseyourentireinvestment.
Inmakinganinvestmentdecision,investorsmustrelyontheirownexaminationoftheissuerandthetermsoftheoffering,includingthemeritsandrisksinvolved.Thesesecuritieshavenotbeenrecommendedorapprovedbyanyfederalorstatesecuritiescommissionorregulatoryauthority.Furthermore,theseauthoritieshavenotpassedupontheaccuracyoradequacyofthisdocument.
TheU.S.SecuritiesandExchangeCommissiondoesnotpassuponthemeritsofanysecuritiesofferedorthetermsoftheoffering,nordoesitpassupontheaccuracyorcompletenessofanyofferingdocumentorliterature.
Thesesecuritiesareofferedunderanexemptionfromregistration;however,theU.S.SecuritiesandExchangeCommissionhasnotmadeanindependentdeterminationthatthesesecuritiesareexemptfromregistration.
7. MaterialfactorsthatmakeaninvestmentinZENII,LLCspeculativeorrisky:
1. Ourshortoperatinghistorymaymakeitdifficultforyoutoevaluatethesuccessofourbusinesstodateandourfutureviability.Start-upinvestingisrisky.Investinginearly-stagecompaniesisveryrisky,highlyspeculative,andshouldnotbemadebyanyonewhocannotaffordtolosetheirentireinvestment.Weareadevelopmentstagebiopharmaceuticalcompanywithaverylimitedoperatinghistory.Developingandcommercializingourcurrentproductcandidateandanyfutureproductcandidateswillrequiresignificantpre-clinicalandclinicaltesting,aswellasregulatoryapprovalsforcommercializationandmarketingbeforewewillbeallowedtobeginanysignificantproductsales.Inaddition,commercializationofourproductcandidateslikelywouldrequireustoestablishasalesandmarketingorganizationandcontractualrelationshipstoenableproductmanufacturingandotherrelatedactivities.Consequently,itmaybedifficultforyoutomakeanypredictionsaboutourfuturesuccessorviability.
2. Wehaveincurredsignificantlossessinceinception.Weexpecttocontinuetoincurlossesfortheforeseeablefutureandmayneverachieveormaintainprofitability.Wehaveincurredlossesineachyearsinceinceptionandexpecttocontinuetoexperiencelossesoverthenextseveralyears.AsofDecember31,2017,wehadanaccumulateddeficitofapproximately$193,023.Ourprincipalintellectualpropertyislicensedfromanaffiliatedcompany,Allovate,LLC,asdescribedunder“RelatedPartyTransactions.”ThelicenseagreementwithAllovateprovidesforlicensepaymentsontheachievementofspecifiedmilestones,includingmilestonepaymentsbeforeregulatoryapprovalisreceivedtosellanylicensedproduct,andtheassumptionof$500,000ofindebtedness,plusinterest,incurredbyAllovateinacquiringsomeofthelicensedpatentrights.Further,wearerequiredtoannuallyspendnotlessthan$4,000,000forthedevelopmentoflicensedproductsduringthefirstfiveyearsoftheagreement.Weexpecttocontinuetoincursignificantoperatingexpensesandanticipatethatourexpensesandlosseswillincreaseintheforeseeablefutureasweseekto:•gainregulatoryapprovalsforourproductsthatsuccessfullycompleteclinicaltrials;•maintain,expandandprotectourintellectualpropertyportfolio;•seektocommercializeourproducts;•hireadditionalclinical,regulatory,qualitycontrol,scientificandmanagementpersonnel;and•addoperational,financial,accounting,facilitiesengineering,manufacturingandinformationsystemspersonnel,consistentwithexpandingouroperations.Tobecomeandremainprofitable,wemustsucceedindevelopingandeventuallycommercializingproductswithsignificantmarketpotential.Thiswillrequireustobesuccessfulinarangeofchallengingactivities,includingsuccessfullycompletingpreclinicaltestingandclinicaltrialsofourproducts,obtainingregulatoryapprovalforourproductsandmanufacturing,marketingandsellingourproducts.Weareonlyinthepreliminarystagesofmanyoftheseactivities.Wemayneversucceedintheseactivitiesandmaynevergeneraterevenuesthataresignificantorlargeenoughtoachieveprofitability.Evenifwedoachieveprofitability,wemaynotbeabletosustainorincreaseprofitabilityonaquarterlyorannualbasis.Ourfailuretobecomeandremainprofitablewoulddepressthepriceofourequitysecuritiesandcouldimpairourabilitytoraisecapital,expandourbusinessorcontinueouroperations.
3. Wewillneedsubstantialadditionalfundingandmaybeunabletoraisecapitalwhenneeded,whichwouldforceustodelay,reduceoreliminateourproductdevelopmentprogramsor
commercializationefforts.Weareapre-clinicalstagecompanyfocusedonthedevelopmentofanoralmucosalimmunotherapyplatformforthetreatmentoffoodallergies.Weanticipatethatourproductcandidateswillnotbecommerciallyavailableforseveralyears,ifatall.
4. Weexpectthatourresearchanddevelopmentexpenseswillcontinuetoincreaseinconnectionwithourongoingactivities,particularlyaswecommenceclinicaldevelopmentforourproducts.Wewillneedtoraiseadditionalfundstocompleteourplannedclinicaltrialprograms.Iftheearlystageclinicaltrialsofourproductsproducepositiveresults,wemayneedtoenterintooneormorecollaborationagreementswithoneormorethirdpartiestoconductandfundlarger,later-stageclinicaltrials,includingpotentialpivotalPhase3clinicaltrials.Ifwearenotabletoenterintocollaborationagreementsontermsthatareacceptabletous,wewillneedtoraiseadditionalcapitaltofundthesetrialsordelayorabandonthetrials.Inaddition,weexpecttoincursignificantcommercializationexpensesforproductsalesandmarketing.Accordingly,weexpectthatwewillneedsubstantialadditionalfundingandmaybeunabletoraisecapitalwhenneededoronattractiveterms,whichwouldforceustodelay,reduceoreliminateourresearchanddevelopmentprogramsorcommercializationefforts.Ourfuturecapitalrequirementswilldependonmanyfactors,including:•thescope,progressandresultsofourresearchandpreclinicaldevelopmentprograms;•thescope,progress,results,costs,timingandoutcomesoftheclinicaltrialsofourproducts;•thetimingofenteringinto,andthetermsof,oneormorecollaborationagreementswithoneormorethirdpartiesforourproducts;•thetimingofandthecostsinvolvedinobtainingregulatoryapprovalsforourproducts;•thecostsofoperating,expandingandenhancingmanufacturingfacilitiesandcapabilitiestosupportourclinicalactivitiesandourcommercializationactivities;•thecostsofmaintaining,expandingandprotectingourintellectualpropertyportfolio,includingpotentiallitigationcostsandliabilities;•revenuesreceivedfromsalesofourproducts;and•thecostsofadditionalgeneralandadministrativepersonnel,includingaccountingandfinance,legalandhumanresourcesemployees.Asaresultoftheseandotherfactors,weexpectthatwewillseekadditionalfundinginthefuture.Wewouldlikelyseeksuchfundingthroughdebtorequityfinancingsorsomecombinationofthetwo.Wewillalsolikelyseekfundingthroughcollaborativearrangementsifwedeterminethemtobenecessaryorappropriate.Additionalfundingmaynotbeavailableonacceptableterms,oratall.Ifweobtaincapitalthroughcollaborativearrangements,thesearrangementscouldrequireustorelinquishrightstoourtechnologyorproductsandcouldresultinusreceivingonlyaportionoftherevenuesassociatedwiththepartneredproduct.Ifweraisecapitalthroughthesaleofequity,orsecuritiesconvertibleintoequity,itwouldresultindilutiontoourthenexistingequityholders.Ifweraiseadditionalcapitalthroughtheincurrenceofindebtedness,wewouldlikelybecomesubjecttocovenantsrestrictingourbusinessactivities,andholdersofdebtinstrumentswouldhaverightsandprivilegesseniortothoseofourequityinvestors.Inaddition,servicingtheinterestandprincipalrepaymentobligationsunderdebtfacilitiescoulddivertfundsthatwouldotherwisebeavailabletosupportresearchanddevelopment,clinicalorcommercializationactivities.Ifweareunabletoobtainadequatefinancingonatimelybasisinthefuture,wewouldlikelyberequiredtodelay,reduceoreliminateoneormoreproductdevelopmentprograms.
5. Ifwefailtosuccessfullymanageourgrowth,ourbusinesscouldbeadverselyaffected.Weanticipateincreasingthescaleofouroperationsaswedevelopourproducts.Ifweareunabletomanageourgrowtheffectively,ouroperationsandfinancialconditioncouldbeadverselyaffected.Themanagementofourgrowthwilldepend,amongotherthings,uponourabilitytodevelopandimproveouroperational,financialandmanagementcontrols,reportingsystemsandprocedures.Furthermore,wemayhavetomakeinvestmentsinandhireandtrainadditionalpersonnelforouroperations,whichwouldresultinadditionalburdensonoursystemsandresourcesandrequireadditionalcapitalexpenditures.
6. Ourproductdevelopmentprogramswillbebasedonnoveltechnologiesandareinherentlyrisky.Wewillbesubjecttotherisksoffailureinherentinthedevelopmentofproductsbasedonnewtechnologies.Thenovelnatureofouroralmucosalimmunotherapyplatformforthetreatmentoffoodallergiescreatessignificantchallengeswithrespecttoproductdevelopmentandoptimization,manufacturing,governmentregulationandapproval,third-partyreimbursementandmarketacceptance.TherearecurrentlynooralimmunotherapyproductsapprovedbytheFDAforthetreatmentoffoodallergies,increasingtheuncertaintyofanyfutureregulatoryapprovalofourproducts.TheFDAmaynotapproveourproductsormayapprovethemwithcertainrestrictionsthatmaylimitourabilitytomarketourproducts,andour
productsmaynotbesuccessfullycommercialized,ifatall.7. Ourclinicaltrialsmaynotbesuccessful.Weintendtoconductclinicalstudies.Preclinicaland
clinicaltestingisexpensive,difficulttodesignandimplementandcantakemanyyearstocomplete.Afailureofoneormoreofourpreclinicalstudiesorclinicaltrialscanoccuratanystageoftesting.Wemayexperiencenumerousunforeseeneventsduring,orasaresultof,preclinicaltestingandtheclinicaltrialprocessthatcoulddelayorpreventourabilitytoobtainregulatoryapprovalorcommercializeourproducts,including:•ourpreclinicaltestsorclinicaltrialsmayproducenegativeorinconclusiveresults,andwemaydecide,orregulatorsmayrequireus,toconductadditionalpreclinicaltestingorclinicaltrialsorwemayabandonprojectsthatwecurrentlyexpecttobepromising;•regulatorsorinstitutionalreviewboardsmaynotauthorizeustocommenceaclinicaltrialorconductaclinicaltrialataprospectivetrialsite;•enrollmentinclinicaltrialsmaytakelongerthanexpectedortheclinicaltrialsasdesignedmaynotallowforsufficientpatientaccrualtocompleteenrollmentofthetrial;•conditionsimposedbytheFDAoranynon-USregulatoryauthorityregardingthescopeordesignofourclinicaltrialsmayrequireustosubmitinformationtoregulatoryauthorities,ethicscommitteesorothersforreviewandapproval;•thenumberofpatientsrequiredforourclinicaltrialsmaybelargerthananticipatedorparticipantsmaydropoutofclinicaltrialsatahigherratethananticipated;•thirdpartycontractorsorclinicalinvestigatorsmayfailtocomplywithregulatoryrequirementsorfailtomeettheircontractualobligationsinatimelymanner;•wemayhavetosuspendorterminateclinicaltrialsifwe,regulatorsorinstitutionalreviewboardsdeterminethattheparticipantsarebeingexposedtounacceptablehealthrisks;•wemaynotbeabletodemonstratethatourproductsprovideanadvantageovercurrentstandardofcareorfuturecompetitivetherapiesindevelopment;•regulatorsorinstitutionalreviewboardsmayrequireustohold,suspendorterminateclinicalresearchforvariousreasons,includingnoncompliancewithregulatoryrequirements;•thecostofclinicaltrialsmaybegreaterthananticipated;•thesupplyorqualityofthematerialsnecessarytoconductclinicaltrialsmaybeinsufficientorinadequateorwemaynotbeabletoreachagreementsonacceptabletermswithprospectiveclinicalresearchorganizations;and•theeffectsofourformulationsmaynotbethedesiredeffectsormayincludeundesirablesideeffects.Wehavelimitedexperienceinconductingandmanagingthepreclinicaldevelopmentactivitiesandclinicaltrialsnecessarytoobtainregulatoryapprovals,includingapprovalbytheFDA.Ourlimitedexperiencemightpreventusfromsuccessfullydesigningorimplementingaclinicaltrial.Wehavelimitedexperienceinconductingandmanagingtheapplicationprocessnecessarytoobtainregulatoryapprovalsandmightnotbeabletodemonstratethatourproductsmeettheappropriatestandardsforregulatoryapproval.Ifwearenotsuccessfulinconductingandmanagingourpreclinicaldevelopmentactivitiesorclinicaltrialsorobtainingregulatoryapprovals,wemightnotbeabletocommercializeourproducts,ormightbesignificantlydelayedindoingso,whichwillmateriallyharmourbusiness.
8. Ifwearenotabletoretainqualifiedmanagementandscientificpersonnel,wemayfailtodevelopourtechnologiesandproductcandidates.Ourfuturesuccessdependstoasignificantextentontheskills,experienceandeffortsoftheprincipalmembersofourscientificandmanagementpersonnel.ThesemembersincludeMichaelNelson,ErickBerglund,PhDandAnthonyRobinson.Thelossofanyoneofthesepeoplecouldharmourbusinessandmightsignificantlydelayorpreventtheachievementofresearch,developmentorbusinessobjectives.Competitionforpersonnelisintense.Wemayfinditdifficulttoretainqualifiedmanagementandscientificpersonnel.Wemaybeunabletoretainourcurrentpersonnelorattractorintegrateotherqualifiedmanagementandscientificpersonnelinthefuture.
9. Wemaynotbeabletosecureandmaintainrelationshipswithresearchinstitutionsandclinicalinvestigatorsthatarecapableofconductingandhaveaccesstonecessarypatientpopulationsfortheconductourclinicaltrials.Wewillrelyonresearchinstitutionsandclinicalinvestigatorstoconductourclinicaltrials.Ourrelianceuponresearchinstitutions,includinghospitalsandclinics,providesuswithlesscontroloverthetimingandcostofclinicaltrialsandtheabilitytorecruitsubjects.Ifweareunabletoreachagreementwithsuitableresearchinstitutionsandclinicalinvestigatorsonacceptableterms,orifanyresultingagreementisterminatedbecause,forexample,theresearchinstitutionand/orclinicalinvestigatorslosetheirlicensesorpermitsnecessarytoconductourclinicaltrials,wemaybeunabletoquicklyreplacetheresearchinstitutionand/orclinicalinvestigatorwithanotherqualifiedresearchinstitutionand/orclinicalinvestigatoronacceptableterms.Wemaynotbeabletosecureandmaintainagreementwith
suitableresearchinstitutionstoconductourclinicaltrials.10. Developmentsbycompetitorsmayrenderourproductsortechnologiesobsoleteornon-
competitive.Thebiotechnologyandpharmaceuticalindustriesareintenselycompetitiveandsubjecttorapidandsignificanttechnologicalchange.Ouroralmucosalimmunotherapyplatformforthetreatmentoffoodallergieshastocompetewithexistingtreatments.Inaddition,companiesarepursuingthedevelopmentofpharmaceuticalsthattargetthesameconditionsthatwearetargeting.WefacecompetitionfrompharmaceuticalandbiotechnologycompaniesintheUnitedStatesandabroad.Inaddition,companiespursuingdifferentbutrelatedfieldsrepresentsubstantialcompetition.Manyoftheseorganizationscompetingwithushavesubstantiallygreatercapitalresources,largerresearchanddevelopmentstaffsandfacilities,longerproductdevelopmenthistoryinobtainingregulatoryapprovalsandgreatermanufacturingandmarketingcapabilitiesthanwedo.Theseorganizationsalsocompetewithustoattractqualifiedpersonnelandpartiesforacquisitions,jointventuresorothercollaborations.
11. Ourproductsmaynotgainmarketacceptance,whichwouldhaveanegativeimpactonoursales.Ourproductsmaynotgainmarketacceptancebyphysicians,patients,third-partypayorsandothersinthemedicalcommunity.Iftheproductsdonotachieveanadequatelevelofacceptance,wemaynotgeneratesignificantproductrevenueandmaynotbecomeprofitable.Thedegreeofmarketacceptanceofourproductswilldependonanumberoffactors,including:•Theprevalenceandseverityofanysideeffects,includinganylimitationsorwarningscontainedinapprovedlabeling;•Theefficacyandpotentialadvantagesoveralternativetreatmentsoravoidance,suchasoralimmunotherapy,epicutaneousimmunotherapyandallergymedications;•Productpricing;•Thewillingnessofthetargetpatientpopulationtotrynewtherapiesandofphysicianstoprescribethesetherapies;•Thestrengthofmarketinganddistributionsupportandtimingofmarketintroductionofcompetitiveproducts;•Publicityconcerningusorcompetingproductsandtreatments;and•Sufficientthird-partyinsurancecoverageorreimbursement.Oureffortstoeducatethemedicalcommunityandthird-partypayorsonthebenefitsofourproductsmayrequiresignificantresourcesandmayneverbesuccessful.Sucheffortstoeducatethemarketplacemayrequiremoreresourcesthanarerequiredbytheconventionaltechnologiesmarketedbyourcompetitors.
12. Wemaynotbeabletodevelopthecollaborativerelationshipsthatwemayneedtodevelopandmarketourproducts.Wewillseektopursuepartnershipopportunities,licensingrelationshipsandothercollaborativerelationshipsthatwillexpandandenhanceourproductdevelopmentplans,including,amongotherthings,partnersthatwouldprovideuswithexpertiseinstabilizingallergenformulationsandpermitourlong-termaccesstovalidatedallergensources.Relianceonpartnerships,licensesandcollaborativerelationshipsposesanumberofrisks,however,includingthefollowing:•Wemayfacesignificantcompetitioninseekingappropriatecollaboratorsandlicensees;•Collaborationandlicensingarrangementsarecomplexandtimeconsumingtonegotiate,documentandimplement;•Wemaynotbesuccessfulinoureffortstoestablishandimplementcollaborations,licensesorotheralternativearrangementsthatwemightpursueonfavorableterms;•Wemaynotbeabletoeffectivelycontrolwhetherourpartnerswilldevotesufficientresourcestoourprogramsorproducts;•Disputesmayariseinthefuturewithrespecttotheownershipofrightstotechnologydevelopedwith,licensedtoorlicensedfrompartners;•Disagreementswithpartnersandlicenseesaredifficulttoresolveandcouldresultinlossofintellectualpropertyrights,delayorterminatetheresearch,developmentorcommercializationofproductcandidatesorresultinlitigationorarbitration;•Contractswithpartnersandlicensesmayfailtoprovidesufficientprotectionofourintellectualproperty;and•Wemayhavedifficultyenforcingthecontractsifoneofthesepartnersorlicenseesfailstoperform.Agreatdealofuncertaintyexistsregardingthesuccessofanycollaborativeefforts.Failureoftheseeffortscoulddelay,impairorpreventthedevelopmentandcommercializationofourproductsandadverselyaffectourbusiness,financialcondition,resultsofoperationsandprospects.
13. Ifproductliabilitylawsuitsarebroughtagainstus,wemayincursubstantialliabilitiesandmayberequiredtolimitcommercializationofourproductcandidates.Themanufactureandsaleofhumantherapeuticproductsinvolvesaninherentriskofproductliabilityclaimsandassociatedadversepublicity.Wefaceproductliabilityexposurerelatedtothetestingofourproductcandidatesinhumanclinicaltrials,andclaimscouldbebroughtagainstusifuseormisuseofoneofourproductcandidatescauses,ormerelyappearstohavecaused,personalinjuryordeath.Weintendtoobtainproductliabilityinsuranceforourproductsanddevelopment
program,butwedonotknowifwewillbeabletocontinuetoobtainproductliabilityinsuranceonacceptabletermsorwithadequatecoverageagainstpotentialliabilitiesinthefuture.Thistypeofinsuranceisexpensiveandmaynotbeavailableonacceptableterms.Ifweareunabletomaintainsufficientinsurancecoverageonreasonabletermsortootherwiseprotectagainstpotentialproductliabilityclaims,wemaybeunabletocommercializeourproducts.Asuccessfulproductliabilityclaimbroughtagainstusinexcessofitsinsurancecoverage,ifany,mayrequirepaymentofsubstantialamountsandhaveamaterialadverseeffectonourbusiness,financialcondition,resultsofoperationsorfutureprospects.
14. Ifweareunabletoprotectourintellectualproperty,ourcompetitivenessandbusinessprospectsmaybemateriallydamaged.Oursuccesswilldependinpartonourabilitytoprotectproprietarytechnologyandtoobtainpatentprotectionforourproducts,preventthirdpartiesfrominfringingonourpatentsandrefrainfrominfringingonthepatentsofothers,bothdomesticallyandinternationally.Webelievethatwehaveaccesstothematerialintellectualpropertythatweneedtodevelopandcommercializeourproductcandidatesascurrentlycontemplated,butinthefuturewemayneedaccesstoadditionalintellectualpropertyifourplanschangeorunforeseencircumstancesarise.Anyarrangementwithrespecttosuchintellectualpropertyrightsmayresultindilutiontoourequityholdersandadditionaldebtandroyaltyobligationsandotherpaymentobligationsforus.Inaddition,thepatentsituationinthefieldofbiotechnologyandpharmaceuticalsgenerallyishighlyuncertainandinvolvescomplexlegal,technical,scientificandfactualquestions.Weintendtoactivelypursuepatentprotectionforproductsresultingfromourresearchanddevelopmentactivitiesthathavesignificantpotentialcommercialvalue.Wemaynotbeabletoobtainissuedpatentsrelatingtoourtechnologyorproducts.Evenifissued,patentsissuedtousorourlicensorsmaybechallenged,narrowed,invalidated,heldtobeunenforceableorcircumvented,whichcouldlimitourabilitytostopcompetitorsfrommarketingsimilarproductsorreducethetermofpatentprotectionwemayhaveforourproducts.Therecanbenoassurancethatanypatentsobtainedwillafforduswithadequateprotectionorprovideuswithanymeaningfulcompetitiveadvantagesagainstthesecompetitors.ChangesineitherpatentlawsorininterpretationsofpatentlawsintheUSandothercountriesmaydiminishthevalueofourintellectualpropertyornarrowthescopeofourpatentprotection.Inaddition,anypatentsweprocuremayrequirecooperationwithcompaniesholdingrelatedpatentsandwemayhavedifficultyformingasuccessfulrelationshipwithsuchothercompanies.Thirdpartiesmayclaimthatweareinfringinguponorhavemisappropriatedtheirproprietaryrights.Wecangivenoassurancesastowhetheranyissuedpatents,orpatentsthatmaylaterissuetothirdparties,wouldaffectourcontemplatedcommercializationofourproductcandidates.Wecangivenoassurancesthatsuchpatentscanbeavoided,invalidatedorlicensed.Withrespecttoanyinfringementclaimassertedbyathirdparty,wecangivenoassurancesthatwewillbesuccessfulinthelitigationorthatsuchlitigationwouldnothaveamaterialadverseeffectonourbusiness,financialcondition,resultsofoperationorprospects.Intheeventofasuccessfulclaimagainstusforinfringementormisappropriationofathirdparty’sproprietaryrights,wemayberequiredto:•Paydamages,includinguptotrebledamages,andtheotherparty’sattorneys’fees,whichmaybesubstantial;•Ceasethedevelopment,manufacture,marketingandsaleofproductsoruseofprocessesthatinfringetheproprietaryrightsofothers;•Expendsignificantresourcestoredesignourproductsorourprocessessothattheydonotinfringetheproprietaryrightsofothers,whichmaynotbepossible;•Redesignourproductsorprocessestoavoidthird-partyproprietaryrights,whichmeanswemaysuffersignificantregulatorydelaysassociatedwithconductingadditionalclinicaltrialsorotherstepstoobtainregulatoryapproval;and•Obtainoneormorelicensesarisingoutofasettlementoflitigationorotherwisefromthirdpartiesfortheinfringedproprietaryrights,whichmaynotbeavailabletousonacceptabletermsoratall.Furthermore,litigationwithanythirdparty,eveniftheallegationsarewithoutmerit,wouldlikelybeexpensiveandtime-consuminganddivertmanagement’sattention.Inaddition,wemayhavetoundertakecostlylitigationtoenforceanypatentsissuedorlicensedtousortodeterminethescopeandvalidityofanotherparty’sproprietaryrights.Anadverseoutcomeinlitigationorinterferenceorotherproceedinginanycourtorpatentofficecouldmateriallyadverselyaffectourabilitytodevelopandcommercializeourproducts.Inadditiontopatents,weandourpartnersalsorelyontradesecretsandproprietaryknow-how.Althoughwehavetakenstepstoprotectourtradesecretsandunpatentedknow-how,includingenteringintoconfidentialityagreementswiththirdparties,andconfidentialinformationandinventionsagreementswithemployees,consultantsand
advisors,thirdpartiesmaystillobtainthisinformationorcomeuponthissameorsimilarinformationindependently.Ifanyoftheseeventsoccurs,orweotherwiseloseprotectionforourtradesecretsorproprietaryknow-how,thevalueofthisinformationmaybegreatlyreduced.
15. Ifweareunabletosuccessfullymanageourgrowth,ourbusinessmaybeharmed.Oursuccesswilldependupontheexpansionofouroperationsandtheeffectivemanagementofourgrowth,whichwillplaceasignificantstrainonourmanagementandonouradministrative,operationalandfinancialresources.Tomanagethisgrowth,wemustexpandourfacilities,augmentouroperational,financialandmanagementsystemsandhireandtrainadditionalqualifiedpersonnel.Ifweareunabletomanageourgrowtheffectively,ourbusinesswouldbeharmed.
16. Certainofourbusinesspracticesaresubjecttoscrutinybyregulatoryauthorities,aswellastolawsuitsbroughtbyprivatecitizensunderfederalandstatelaws.Failuretocomplywithapplicablelaworanadversedecisioninlawsuitsmayresultinadverseconsequencestous.ThelawsgoverningourconductintheUnitedStatesareenforceablebycriminal,civilandadministrativepenalties.ViolationsoflawssuchastheFederalFood,DrugandCosmeticAct,theFalseClaimsActandtheAnti-KickbackLawandthePublicHealthServiceAct,andanyregulationspromulgatedundertheirauthority,mayresultinjailsentences,finesorexclusionfromfederalandstateprograms,asmaybedeterminedbyMedicare,MedicaidandtheDepartmentofDefenseandotherregulatoryauthoritiesaswellasbythecourts.Therecanbenoassurancethatouractivitieswillnotcomeunderthescrutinyofregulatorsandothergovernmentauthoritiesorthatourpracticeswillnotbefoundtoviolateapplicablelaws,rulesandregulationsorpromptlawsuitsbyprivatecitizen“relators”underfederalorstatefalseclaimslaws.
17. Wecurrentlyhaveonlyoneproductcandidate,whichisatanearlystageofdevelopmentandmaynotbesuccessfullydevelopedorcommercialized.Wecurrentlyhaveoneproductcandidate,whichisintheearlystageofdevelopmentandwillrequiresubstantialfurthercapitalexpenditures,development,testing,andregulatoryclearancespriortocommercialization.Ofthelargenumberofdrugsindevelopment,onlyasmallpercentagesuccessfullycompletetheFDAregulatoryapprovalprocessandarecommercialized.Accordingly,evenifweareabletoobtaintherequisitefinancingtofundourdevelopmentprograms,wecannotassureyouthatourcurrentproductcandidateoranyfutureproductcandidateswillbesuccessfullydevelopedorcommercialized.Ifweareunabletodeveloporunabletoreceiveregulatoryapprovalfororunsuccessfullycommercializeourproductcandidates,wewillnotbeabletogenerateproductrevenues.
18. Becausetheresultsofpreclinicalstudiesandearlyclinicaltrialarenotnecessarilypredictiveoffutureresults,theadvancementofourproductcandidatesintoclinicaltrialsmaynothavefavorableresultsinlaterclinicaltrials,ifany,orreceiveregulatoryapproval.Pharmaceuticalorbiologicdevelopmenthasinherentrisk.Wewillberequiredtodemonstratethroughwell-controlledclinicaltrialsthatourproductcandidatesareeffectivewithafavorablebenefit-riskprofileforuseintheirtargetindicationsbeforewecanseekregulatoryapprovalsfortheircommercialsale.Successinearlyclinicaltrialsdoesnotmeanthatlaterclinicaltrialswillbesuccessfulasaproductcandidateinlater-stagedclinicaltrialsmayfailtodemonstratesufficientsafetyorefficacydespitehavingprogressedthroughinitialclinicaltesting.Companiesfrequentlysuffersignificantsetbacksinadvancedclinicaltrials,evenafterearlierclinicaltrialshaveshownpromisingresults.Inaddition,onlyasmallpercentageofdrugsunderdevelopmentresultinsubmissionofaBLAtotheFDAandevenfewerareapprovedforcommercialization.
19. Anyproductcandidatewemayadvanceintoclinicaldevelopmentissubjecttoextensiveregulation,whichcanbecostlyandtimeconsuming,causeunanticipateddelaysorpreventthereceiptoftherequiredapprovalstocommercializeourproductcandidates.Theclinicaldevelopment,manufacturing,labeling,storage,record-keeping,advertising,promotion,import,export,marketinganddistributionofourcurrentproductcandidateoranyfutureproductcandidateissubjecttoextensiveregulationbytheFDAintheUnitedStatesandbycomparablehealthauthoritiesinforeignmarkets.IntheUnitedStates,wearenotpermittedtomarketanyproductcandidatesuntilwereceiveapprovalofaBLAfromtheFDA.TheprocessofobtainingBLAapprovalisexpensive,oftentakesmanyyearsandcanvarysubstantiallybaseduponthetype,complexityandnoveltyoftheproductsinvolved.ApprovalpoliciesorregulationsmaychangeandtheFDAhassubstantialdiscretioninthepharmaceuticalapprovalprocess,includingtheabilitytodelay,limitordenyapprovalofaproductcandidateformanyreasons.
Despitethetimeandexpenseinvestedinclinicaldevelopmentofproductcandidates,regulatoryapprovalisneverguaranteed.TheFDAorandotherregulatoryagenciescandelay,limitordenyapprovalofaproductcandidateformanyreasons,including:·theFDAorcomparableforeignregulatoryauthoritiesmaydisagreewiththedesignorimplementationofourclinicaltrials;·wemaybeunabletodemonstratetothesatisfactionoftheFDAthataproductcandidateissafeandeffectiveforanyindication;·theFDAmaynotacceptclinicaldatafromtrialswhichareconductedbyindividualinvestigatorsorincountrieswherethestandardofcareispotentiallydifferentfromtheUnitedStates;·theresultsofclinicaltrialsmaynotmeetthelevelofstatisticalsignificancerequiredbytheFDAforapproval;·wemaybeunabletodemonstratethataproductcandidate’sclinicalandotherbenefitsoutweighitssafetyrisks;·theFDAmaydisagreewithourinterpretationofdatafrompreclinicalstudiesorclinicaltrials;·theFDAmayfailtoapprovethemanufacturingprocessesorfacilitiesofthird-partymanufacturerswithwhichweorourcollaboratorscontractforclinicalandcommercialsupplies;or·theapprovalpoliciesorregulationsoftheFDAmaysignificantlychangeinamannerrenderingourclinicaldatainsufficientforapproval.Withrespecttoforeignmarkets,approvalproceduresvaryamongcountries,and,inadditiontotheaforementionedrisks,caninvolveadditionalproducttesting,administrativereviewperiodsandagreementswithpricingauthorities.Anydelayinobtaining,orinabilitytoobtain,applicableregulatoryapprovalswouldpreventusfromcommercializingourproductcandidates.
20. Anyproductcandidatesweadvanceintoclinicaltrialsmaycauseunacceptableadverseeventsorhaveotherpropertiesthatmaydelayorpreventtheirregulatoryapprovalorcommercializationorlimittheircommercialpotential.Unacceptableadverseeventscausedbyanyproductcandidatethatweadvanceintoclinicaltrialscouldcauseusorregulatoryauthoritiestointerrupt,delayorhaltclinicaltrialsandcouldresultinthedenialofregulatoryapprovalbytheFDAorotherregulatoryauthoritiesforanyoralltargetedindicationsandmarkets.Thisinturn,couldpreventusfromcommercializingtheaffectedproductcandidateandgeneratingrevenuesfromitssale.Wehavenotyetbegunclinicaltestingofanyproductcandidateforthetreatmentoftheindicationsforwhichweintendtoseekproductapprovalinhumans,andwecurrentlydonotknowtheextentofadverseevents,ifany,thatwillbeobservedinpatientswhomayreceiveourcurrentproductcandidateoranyfutureproductcandidates.Ifanyofourproductcandidatescausesunacceptableadverseeventsinclinicaltrials,wemaynotbeabletoobtainregulatoryapprovalorcommercializesuchproduct.
21. Wemayexperiencedelaysinthecommencementofourclinicaltrialsorinthereceiptofdatafromthirdparties,whichcouldresultinincreasedcostsanddelayourabilitytopursueregulatoryapproval.Delaysinthecommencementofclinicaltrialsanddelaysinthereceiptofdatafrompreclinicalorclinicaltrialsconductedbythirdpartiescouldsignificantlyimpactourproductdevelopmentcostsandthetimerequiredtocommercializeourproducts.BeforewecaninitiateclinicaltrialsintheUnitedStatesforanyproductcandidate,weneedtosubmittheresultsofpreclinicaltestingtotheFDAaspartofanIND,alongwithotherinformationincludinginformationaboutproductchemistry,manufacturingandcontrolsandourproposedclinicaltrialprotocol.Wecurrentlyplantorelyonpreclinical,clinicalandqualitydatafromthirdpartiesfortheINDsubmissionforourcurrentproductcandidateandanyfutureproductcandidates.Ifweareunabletousesuchdataforanyreason,includingreasonsoutsideofourcontrol,itwilldelayourplansforINDfilings,andclinicaltrialplans.Ifthosethirdpartiesdonotmakethisdataavailabletous,wewilllikely,onourown,havetodevelopallthenecessarypreclinicalandclinicaldatawhichwillleadtoadditionaldelaysandincreasethecostsofourdevelopmentofproductcandidates.Inaddition,theFDAmayrequireustoconductadditionalpreclinicaltestingforanyproductcandidatebeforeitallowsustoinitiatetheclinicaltestingunderanyIND,whichmayleadtoadditionaldelaysandincreasethecostsofourpreclinicaldevelopment.EvenassuminganactiveINDforaproductcandidate,clinicaltrialscanbedelayedforavarietyofreasons,includingdelaysin:·obtainingregulatoryclearancetocommenceaclinicaltrial;·identifying,recruitingandtrainingsuitableclinicalinvestigators;·reachingagreementonacceptabletermswithprospectivecontractresearchorganizations(“CROs”)andtrialsites,thetermsofwhichcanbesubjecttoextensivenegotiation,maybesubjecttomodificationfromtimetotimeandmayvarysignificantlyamongdifferentCROsandtrialsites;·obtainingsufficientquantitiesofaproductcandidateforuseinclinicaltrials;·obtainingIRBorethicscommitteeapprovaltoconductaclinicaltrialataprospectivesite;·identifying,recruitingandenrollingpatientstoparticipateinaclinicaltrial;and·retaining
patientswhohaveinitiatedaclinicaltrialbutmaywithdrawduetoadverseeventsfromthetherapy,insufficientefficacy,fatiguewiththeclinicaltrialprocessorpersonalissues.Anydelaysinthecommencementofourclinicaltrialswilldelayourabilitytopursueregulatoryapprovalforourproductcandidates.Inaddition,manyofthefactorsthatcause,orleadto,adelayinthecommencementofclinicaltrialsmayalsoultimatelyleadtothedenialofregulatoryapprovalofaproductcandidate.
22. Delaysinthecompletionofclinicaltestingcouldresultinincreasedcoststousanddelayourabilitytogenerateproductrevenues.Onceaclinicaltrialhasbegun,patientrecruitmentandenrollmentmaybeslowerthanweanticipate.Clinicaltrialsmayalsobedelayedasaresultofambiguousornegativeinterimresults.Further,aclinicaltrialmaybesuspendedorterminatedbyus,anIRB,anethicscommitteeoraDataMonitoringCommitteeoverseeingtheclinicaltrial,anyofourclinicaltrialsiteswithrespecttothatsiteortheFDAorotherregulatoryauthoritiesduetoanumberoffactors,including:·failuretoconducttheclinicaltrialinaccordancewithregulatoryrequirementsorourclinicalprotocols;·inspectionoftheclinicaltrialoperationsorclinicaltrialsitebytheFDAorotherregulatoryauthoritiesresultingintheimpositionofaclinicalhold;·unforeseensafetyissuesoranydeterminationthattheclinicaltrialpresentsunacceptablehealthrisks;and·lackofadequatefundingtocontinuetheclinicaltrial.Changesinregulatoryrequirementsandguidancealsomayoccurandwemayneedtoamendclinicaltrialprotocolstoreflectthesechanges.AmendmentsmayrequireustoresubmitourclinicaltrialprotocolstoIRBsforre-examination,whichmayimpactthecosts,timingandthelikelihoodofasuccessfulcompletionofaclinicaltrial.Ifweexperiencedelaysinthecompletionof,orifwemustterminate,anyclinicaltrialofanyproductcandidate,ourabilitytoobtainregulatoryapprovalforthatproductcandidatewillbedelayedandthecommercialprospects,ifany,fortheproductcandidatemaysufferasaresult.Inaddition,manyofthesefactorsmayalsoultimatelyleadtothedenialofregulatoryapprovalofaproductcandidate.
23. Weintendtorelyonthirdpartiestoconductourclinicaltrials.Ifthesethirdpartiesdonotmeetourdeadlinesorotherwiseconductthetrialsasrequired,ourclinicaldevelopmentprogramscouldbedelayedorunsuccessfulandwemaynotbeabletoobtainregulatoryapprovalfororcommercializeourproductcandidateswhenexpectedoratall.Wedonothavetheabilitytoconductallaspectsofourpreclinicaltestingorclinicaltrialsourselves.WeintendtouseCROstoconductourplannedclinicaltrialsandwillrelyuponmedicalinstitutions,clinicalinvestigatorsandcontractresearchorganizationsandconsultantstoconductourtrialsinaccordancewithourclinicalprotocols.OurfutureCROs,investigatorsandotherthirdpartiesplayasignificantroleintheconductofthesetrialsandthesubsequentcollectionandanalysisofdatafromtheclinicaltrials.ThereisnoguaranteethatanyCROs,investigatorsandotherthirdpartiesuponwhichwerelyforadministrationandconductofourclinicaltrialswilldevoteadequatetimeandresourcestosuchtrialsorperformascontractuallyrequired.Ifanyofthesethirdpartiesfailtomeetexpecteddeadlines,failtoadheretoourclinicalprotocolsorotherwiseperforminasubstandardmanner,ourclinicaltrialsmaybeextended,delayedorterminated.Ifanyofourclinicaltrialsitesterminateforanyreason,wemayexperiencethelossoffollow-upinformationonpatientsenrolledinourongoingclinicaltrialsunlessweareabletotransferthecareofthosepatientstoanotherqualifiedclinicaltrialsite.Inaddition,principalinvestigatorsforourclinicaltrialsmayserveasscientificadvisorsorconsultantstousfromtimetotimeandreceivecashorequitycompensationinconnectionwithsuchservices.Iftheserelationshipsandanyrelatedcompensationresultinperceivedoractualconflictsofinterest,theintegrityofthedatageneratedattheapplicableclinicaltrialsitemaybejeopardized.
24. Ifourcompetitorsdeveloptreatmentsforthetargetindicationsofourproductcandidatesthatareapprovedmorequickly,marketedmoresuccessfullyordemonstratedtobemoreeffectivethanourproductcandidates,ourcommercialopportunitywillbereducedoreliminated.Weoperateinhighlycompetitivesegmentsofthebiotechnologyandbiopharmaceuticalmarkets.Wefacecompetitionfrommanydifferentsources,includingcommercialpharmaceuticalandbiotechnologyenterprises,academicinstitutions,governmentagencies,andprivateandpublicresearchinstitutions.Ourcurrentproductcandidate,ifsuccessfullydevelopedandapproved,willcompetewithestablishedtherapies,aswellasnewtreatmentsthatmaybeintroducedbyourcompetitors.Manyofourcompetitorshavesignificantlygreaterfinancial,productdevelopment,manufacturingandmarketingresourcesthanus.Largepharmaceuticalcompanieshaveextensiveexperienceinclinicaltestingandobtainingregulatoryapprovalfordrugs.Inaddition,manyuniversitiesandprivateandpublicresearchinstitutesareactivein
medicalresearch,someindirectcompetitionwithus.Wealsomaycompetewiththeseorganizationstorecruitmanagement,scientistsandclinicaldevelopmentpersonnel.Smallerorearly-stagecompaniesmayalsoprovetobesignificantcompetitors,particularlythroughcollaborativearrangementswithlargeandestablishedcompanies.Newdevelopments,includingthedevelopmentofotherpharmaceuticaltechnologiesandmethodsoftreatingdisease,occurinthepharmaceuticalandlifesciencesindustriesatarapidpace.Developmentsbycompetitorsmayrenderourproductcandidatesobsoleteornoncompetitive.Wewillalsofacecompetitionfromthesethirdpartiesinrecruitingandretainingqualifiedpersonnel,establishingclinicaltrialsitesandpatientregistrationforclinicaltrialsandinidentifyingandin-licensingnewproductcandidates.
25. Werelycompletelyonthirdpartiestomanufactureourpreclinicalandclinicalpharmaceuticalsuppliesandexpecttocontinuetorelyonthirdpartiestoproducecommercialsuppliesofanyapprovedproductcandidate,andourdependenceonthirdpartysupplierscouldadverselyimpactourbusiness.Wearecompletelydependentonthirdpartymanufacturersforproductsupply.Ifathirdpartybecomesunableorunwillingtodeliversufficientquantitiesofaproductcandidatetousonatimelybasisandinaccordancewithapplicablespecificationsandotherregulatoryrequirements,therecouldbeasignificantinterruptionofoursupply,whichwouldadverselyaffectclinicaldevelopmentandcommercializationoftheproduct.Furthermore,ifathird-partysupplieroranyothercontractmanufacturerscannotsuccessfullymanufacturematerialthatconformstoourspecificationsandwithFDAregulatoryrequirements,wewillnotbeabletosecureand/ormaintainFDAapprovalforourproductcandidates.Wewillalsorelyonourmanufacturerstopurchasefromthird-partysuppliersthematerialsnecessarytoproduceourproductcandidatesforouranticipatedclinicaltrials.Thereareasmallnumberofsuppliersforcertaincapitalequipmentandrawmaterialsthatareusedtomanufactureourproductcandidates.Wedonothaveanycontrolovertheprocessortimingoftheacquisitionoftheserawmaterialsbyourmanufacturers.Moreover,wecurrentlydonothaveanyagreementsforthecommercialproductionoftheserawmaterials.Anysignificantdelayinthesupplyofaproductcandidateortherawmaterialcomponentsthereofforanongoingclinicaltrialcouldconsiderablydelaycompletionofourclinicaltrials,producttestingandpotentialregulatoryapprovalofourproductcandidates.Wedonotexpecttohavetheresourcesorcapacitytocommerciallymanufactureanyofourproposedproducts,ifapproved,andwilllikelycontinuetobedependentuponthirdpartymanufacturers.Ourdependenceonthirdpartiestomanufactureandsupplyuswithclinicaltrialmaterialsandanyapprovedproductsmayadverselyaffectourabilitytodevelopandcommercializeourproductsonatimelybasis.
26. Ifweareunabletoestablishsalesandmarketingcapabilitiesorfailtoenterintoagreementswiththird-partiestomarketandsellanyproductswemaysuccessfullydevelop,wemaynotbeabletoeffectivelymarketandsellanysuchproductsandgenerateproductrevenue.Wedonotcurrentlyhavetheinfrastructureforthesales,marketinganddistributionofanyproductcandidates,andmustbuildthisinfrastructureormakearrangementswiththirdpartiestoperformthesefunctionsinordertocommercializeanyproductsthatwemaysuccessfullydevelop.Theestablishmentanddevelopmentofasalesforce,eitherbyusorjointlywithadevelopmentpartner,ortheestablishmentofacontractsalesforcetomarketanyproductswemaydevelopwillbeexpensiveandtime-consumingandcoulddelayanyproductlaunch.Ifwe,orourdevelopmentpartners,areunabletoestablishsalesandmarketingcapabilityoranyothernon-technicalcapabilitiesnecessarytocommercializeanyproductswemaysuccessfullydevelop,wewillneedtocontractwiththirdpartiestomarketandsellsuchproducts.Wemaynotbeabletoestablisharrangementswiththird-partiesonacceptableterms,ifatall.
27. Ifanyproductcandidatethatwesuccessfullydevelopdoesnotachievebroadmarketacceptanceamongphysicians,patients,healthcarepayorsandthemedicalcommunity,therevenuesthatitgeneratesfromtheirsaleswillbelimited.Evenifourproductcandidatesreceiveregulatoryapproval,theymaynotgainmarketacceptanceamongphysicians,patients,healthcarepayorsandthemedicalcommunity.Coverageandreimbursementofourproductcandidatesbythird-partypayors,includinggovernmentpayors,generallyisalsonecessaryforcommercialsuccess.Thedegreeofmarketacceptanceofanyapprovedproductswilldependonanumberoffactors,including:·theefficacyandsafetyasdemonstratedinclinicaltrials;·theclinicalindicationsforwhichtheproductisapproved;·acceptancebyphysicians,majoroperatorsofhospitalsandclinicsandpatientsoftheproductasasafeandeffectivetreatment;·thepotentialandperceivedadvantagesofproductcandidatesoveralternativetreatments;·thesafetyofproductcandidates
seeninabroaderpatientgroup,includingitsuseoutsidetheapprovedindications;·thecostoftreatmentinrelationtoalternativetreatments;·theavailabilityofadequatereimbursementandpricingbythirdpartiesandgovernmentauthorities;·relativeconvenienceandeaseofadministration;·theprevalenceandseverityofadverseevents;·theeffectivenessofoursalesandmarketingefforts;and·unfavorablepublicityrelatingtotheproduct.Ifanyproductcandidateisapprovedbutdoesnotachieveanadequatelevelofacceptancebyphysicians,hospitals,healthcarepayorsandpatients,wemaynotgeneratesufficientrevenuefromtheseproductsandmaynotbecomeorremainprofitable.
28. Healthcarereformandrestrictionsonreimbursementsmaylimitourfinancialreturns.Ourabilityortheabilityofourcollaboratorstocommercializeanyofourproductcandidatesthatmayreceivetherequisiteregulatoryapprovalmaydepend,inpart,ontheextenttowhichgovernmenthealthadministrationauthorities,privatehealthinsurersandotherorganizationswillreimburseconsumersforthecostoftheseproducts.Thesethirdpartiesareincreasinglychallengingboththeneedforandthepriceofnewdrugproducts.Significantuncertaintyexistsastothereimbursementstatusofnewlyapprovedtherapeutics.Adequatethird-partyreimbursementmaynotbeavailableforourproductcandidatestoenableusorourcollaboratorstomaintainpricelevelssufficienttorealizeanappropriatereturnontheirandourinvestmentsinresearchandproductdevelopment.
29. Weusebiologicalmaterialsandmayusehazardousmaterials,andanyclaimsrelatingtoimproperhandling,storageordisposalofthesematerialscouldbetimeconsumingorcostly.Wemayusehazardousmaterials,includingchemicalsandbiologicalagentsandcompoundsthatcouldbedangeroustohumanhealthandsafetyortheenvironment.Ouroperationsalsoproducehazardouswasteproducts.Federal,stateandlocallawsandregulationsgoverntheuse,generation,manufacture,storage,handlinganddisposalofthesematerialsandwastes.Compliancewithapplicableenvironmentallawsandregulationsmaybeexpensive,andcurrentorfutureenvironmentallawsandregulationsmayimpairourproductdevelopmentefforts.Inaddition,wecannotentirelyeliminatetheriskofaccidentalinjuryorcontaminationfromthesematerialsorwastes.Wedonotcarryspecificbiologicalorhazardouswasteinsurancecoverageandourpropertyandcasualtyandgeneralliabilityinsurancepoliciesspecificallyexcludecoveragefordamagesandfinesarisingfrombiologicalorhazardouswasteexposureorcontamination.Accordingly,intheeventofcontaminationorinjury,wecouldbeheldliablefordamagesorpenalizedwithfinesinanamountexceedingourresources,andourclinicaltrialsorregulatoryapprovalscouldbesuspended.
30. YoumaynotbeabletosellortransferyourClassAUnits.Youshouldnotplanonbeingabletoreadilytransferand/orresellyourClassAUnits.CurrentlythereisnomarketorliquidityfortheClassAUnitsandtheCompanydoesnothaveanyplanstolisttheClassAUnitsoranyotherequitysecuritiesonanexchangeorothersecondarymarket.TheClassAUnitshavenotbeenregisteredundertheSecuritiesActof1933,asamended,norisanysuchregistrationcontemplated.ThesaleortransferofClassAUnitsissubjecttocertaincontractualrestrictionscontainedintheCompany’sOperatingAgreement.Investorsmaynotbeabletoliquidatetheirinvestmentintheeventofemergencyorforanyotherreason.PurchaseofClassAUnitsissuitableonlyforindividualsandentitiesthathavenoneedforliquiditywithrespecttotheirinvestment.
31. OurManagingMembersmayhavelimitsonthetimetheyhavetodevotetotheCompany.ThesuccessoftheCompanywilldependinpartupontheskillandexpertiseoftheManagingMembers.TheManagingMembersandtheiraffiliatesmayhaveconflictsofinterestinallocatingmanagementandadministrativetime,services,andfunctionsamongvariousfutureentities,aswellasotherbusinessventuresinwhichtheyareormaybecomeinvolved.TheManagingMembersandtheiraffiliateswilldevoteonlysomuchoftheirtimetothebusinessoftheCompanyasintheirjudgmentisreasonablyrequired.AllmaterialactionswithrespecttotheCompanywillrequiretheconsentofbothManagingMembers,whichmayleadtodeadlocksanddelayorimpedeimportantcompanyactionsanddecisions.
32. Anyforecastswemakeaboutouroperationsmayprovetobeinaccurate.Wemust,amongotherthings,determineappropriaterisks,rewards,andlevelofinvestmentinourproductcandidates,respondtoeconomicandmarketvariablesoutsideofourcontrol,respondtocompetitivedevelopmentsandcontinuetoattract,retain,andmotivatequalifiedemployees.Therecanbenoassurancethatwewillbesuccessfulinmeetingthesechallengesandaddressingsuchrisksandthefailuretodosocouldhaveamateriallyadverseeffectonourbusiness,resultsof
operations,andfinancialcondition.Ourprospectsmustbeconsideredinlightoftherisks,expenses,anddifficultiesfrequentlyencounteredbycompaniesintheearlystageofdevelopment.Asaresultoftheserisks,challenges,anduncertainties,thevalueofyourinvestmentcouldbesignificantlyreducedorcompletelylost.InformationprovidedconcerningthisOfferingandtheCompany’sbusinessmaycontainforward-lookingstatements,whichcanbeidentifiedby,amongotherthings,theuseofforward-lookinglanguage,suchasthewords“plans,”“intends,”“believes,”“expects,”“anticipates,”“estimates,”“projects,”“potential,”“may,”“will,”“would,”“could,”“should,”“seeks,”or“scheduledto,”orothersimilarwords,orbydiscussionofstrategyorintentions.Suchforwardlookingstatementsreflectmanagement’scurrentviewwithrespecttofutureeventsandtheCompany’sperformance.Suchforward-lookingstatementsmayincludeprojectionswithrespecttoproductdevelopment,marketsizeandacceptance,revenuesandearnings,marketingandsalesstrategies,andbusinessoperations.TheCompanyoperatesinahighlycompetitivebusinessenvironment.TheCompany’sbusinessisandwillcontinuetobeaffectedbygovernmentregulation,economic,politicalandsocialconditions,responseofthemedicalcommunitytoourproducts,technologicaldevelopmentsand,particularlyinviewofnewtechnologies,theabilitytoprotectintellectualpropertyrights.TheCompany’sactualresultscoulddiffermateriallyfrommanagement’sexpectationsbecauseofchangesinsuchfactors.Otherfactorsandriskscouldalsocauseactualresultstodifferfromthosecontainedinforward-lookingstatements.Duetosuchuncertaintiesandtheriskfactorssetforthherein,prospectiveinvestorsarecautionednottoplaceunduerelianceuponsuchforward-lookingstatements.
TheOffering
ZENII,LLC(“Company”)isofferingsecuritiesunderbothRegulationD,throughLivingstonSecurities,LLC(“Livingston”)andRegulationCF,throughNetcapitalFundingPortalInc.(“Portal”).Livingstonisaregisteredbroker-dealer,andmemberFINRA/SIPC.Livingstonwillreceivecashcompensationequalto4.9%ofthevalueofthesecuritiessoldthroughRegulationD.PortalisaFINRA/SECregisteredfundingportalandwillreceivecashcompensationequalto4.9%ofthevalueofthesecuritiessoldthroughRegulationCF.InvestmentsmadeunderbothRegulationDandRegulationCFinvolveahighdegreeofriskandthoseinvestorswhocannotaffordtolosetheirentireinvestmentshouldnotinvest.
Thisofferingisconsideredaside-by-sideoffering,meaningthattheCompanyisraisingcapitalundertwoofferingtypes.TheCompanyplanstoraisebetween$10,000and$2,000,100throughconcurrentofferingsunderRegulationCFandRegulationD–Rule506(c).Specifically,ifwereachthetargetofferingamountof$10,000,wemayconductthefirstofmultipleorrollingclosingsoftheofferingearlyifweprovidenoticeaboutthenewofferingdeadlineatleastfivebusinessdayspriortosuchnewofferingdeadline(absentamaterialchangethatwouldrequireanextensionoftheofferingandreconfirmationoftheinvestmentcommitment).Oversubscriptionswillbeallocatedonafirstcome,firstservedbasis.Changestotheoffering,materialorotherwise,occurringafteraclosing,willonlyimpactinvestmentswhichhaveyettobeclosed.
IntheeventTheCompanyfailstoreachthecombinedofferingtargetof$10,000,anyinvestmentsmadeundereitherofferingwillbecancelledandtheinvestmentfundswillbereturnedtotheinvestor.
TheCompanymayraiseupto$1,070,000fromnon-accreditedinvestorsunderRegulationCF.
AccreditedinvestorswhohaveprovedtheiraccreditationstatustoPortal,willautomaticallyinvestundertheRegulationD-Rule506(c)offeringtype.AllotherinvestorswillinvestundertheRegulationCFofferingtype.AnaccreditedinvestorwhoprovestheiraccreditationstatuswiththePortalpriorto48hoursoftheofferingclosing,canauthorizetheirinvestmenttobewithdrawnfromtheRegulationCFofferingandautomaticallyreinvestedintheRegulationDoffering.YoumustbeanaccreditedinvestortoinvestunderRegulationD.
8. Whatisthepurposeofthisoffering?
IntrommunewillallocateproceedstowardsResearchandDevelopment,specificallypre-clinicalandclinicaldevelopmentandinvestigations,Chemistry,ManufacturingandControls,StabilityTestingandFDAregulatoryrequirementssuchaspre-INDinteractionsandINDfilings.
9. Howdoestheissuerintendtousetheproceedsofthisoffering?
IfTargetOfferingAmountSold
IfMaximumAmountSold
TotalProceeds $10,000 $2,000,100
Less:OfferingExpenses $490 $98,005
NetProceeds $9,510 $1,902,095
ResearchandDevelopment $9,510 $1,090,000
Chemistry,ManufacturingandControls
$0 $250,000
Regulatory $0 $50,000
Operatingcosts $0 $512,096
TotalUseofNetProceeds $9,510 $1,902,096
10. Howwilltheissuercompletethetransactionanddeliversecuritiestotheinvestors?
InenteringintoanagreementontheNetcapitalFundingPortaltopurchasesecurities,bothinvestorsandZENII,LLCmustagreethatatransferagent,whichkeepsrecordsofouroutstandingClassAMembershipUnits(the"Securities"),willissuedigitalSecuritiesintheinvestor’sname(apapercertificatewillnotbeprinted).Similartootheronlineinvestmentaccounts,thetransferagentwillgiveinvestorsaccesstoawebsitetoseethenumberofSecuritiesthattheyowninourcompany.TheseSecuritieswillbeissuedtoinvestorsafterthedeadlinedateforinvestinghaspassed,aslongasthetargetedofferingamounthasbeenreached.Thetransferagentwillrecordtheissuancewhenwehavereceivedthepurchaseproceedsfromtheescrowagentwhoisholdingyourinvestmentcommitment.
11. Howcananinvestorcancelaninvestmentcommitment?
Youmaycancelaninvestmentcommitmentforanyreasonuntil48hourspriortothedeadlineidentifiedintheofferingbyloggingintoyouraccountwithNetcapital,browsingtotheInvestmentsscreen,andclickingtocancelyourinvestmentcommitment.Netcapitalwillnotifyinvestorswhenthetargetofferingamounthasbeenmet.Iftheissuerreachesthetargetofferingamountpriortothedeadlineidentifiedintheofferingmaterials,itmayclosetheofferingearlyifitprovidesnoticeaboutthenewofferingdeadlineatleastfivebusinessdayspriortosuchnewofferingdeadline(absentamaterialchangethatwouldrequireanextensionoftheofferingandreconfirmationoftheinvestmentcommitment).Ifaninvestordoesnotcancelaninvestmentcommitmentbeforethe48-hourperiodpriortotheofferingdeadline,thefundswillbereleasedtotheissueruponclosingoftheofferingandtheinvestorwillreceivesecuritiesinexchangeforhisorherinvestment.Ifaninvestordoesnotreconfirmhisorherinvestmentcommitmentafteramaterialchangeismadetotheoffering,theinvestor’sinvestmentcommitmentwillbecancelledandthecommittedfundswillbereturned.
12. CantheCompanyperformmultipleclosingsorrollingclosingsfortheoffering?
Ifwereachthetargetofferingamountpriortotheofferingdeadline,wemayconductthefirstofmultipleclosingsoftheofferingearly,ifweprovidenoticeaboutthenewofferingdeadlineatleastfivebusinessdaysprior(absentamaterialchangethatwouldrequireanextensionoftheofferingandreconfirmationoftheinvestmentcommitment).Thereafter,wemayconductadditionalclosingsuntiltheofferingdeadline.WewillissueSecuritiesinconnectionwitheachclosing.
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Oversubscriptionswillbeallocatedonafirstcome,firstservedbasis.Changestotheoffering,materialorotherwise,occurringafteraclosing,willonlyimpactinvestmentswhichhaveyettobeclosed.
OwnershipandCapitalStructure
TheOffering
13. Describethetermsofthesecuritiesbeingoffered.
WeareissuingSecuritiesatanofferingpriceof$1.00pershare.
14. Dothesecuritiesofferedhavevotingrights?
TheSecuritiesarebeingissuedwithvotingrights.However,sothatthecrowdfundingcommunityhastheopportunitytoacttogetherandcastavoteasagroupwhenavotingmatterarises,acustodianwillcastyourvoteforyou.Pleaserefertothecustodianagreementthatyousignbeforeyourpurchaseiscomplete.
15. Arethereanylimitationsonanyvotingorotherrightsidentifiedabove?
Youaregivingyourvotingrightstothecustodian,whowillvotetheSecuritiesonbehalfofallinvestorswhopurchasedSecuritiesontheNetcapitalcrowdfundingportal.
16. Howmaythetermsofthesecuritiesbeingofferedbemodified?
Wemaychoosetomodifythetermsofthesecuritiesbeforetheofferingiscompleted.However,ifthetermsaremodified,andwedeemittobeamaterialchange,weneedtocontactyouandyouwillbegiventheopportunitytoreconfirmyourinvestment.Yourreconfirmationmustbecompletedwithinfivebusinessdaysofreceiptofthenoticeofamaterialchange,andifyoudonotreconfirm,yourinvestmentwillbecanceledandyourmoneywillbereturnedtoyou.
RestrictionsonTransferoftheSecuritiesOffered
Thesecuritiesbeingofferedmaynotbetransferredbyanypurchaserofsuchsecuritiesduringtheone-yearperiodbeginningwhenthesecuritieswereissued,unlesssuchsecuritiesaretransferred:
totheissuer;
toanaccreditedinvestor;
aspartofanofferingregisteredwiththeU.S.SecuritiesandExchangeCommission;or
toamemberofthefamilyofthepurchaserortheequivalent,toatrustcontrolledbythepurchaser,toatrustcreatedforthebenefitofamemberofthefamilyofthepurchaserortheequivalent,orinconnectionwiththedeathordivorceofthepurchaserorothersimilarcircumstance.
Theterm“accreditedinvestor”meansanypersonwhocomeswithinanyofthecategoriessetforthinRule501(a)ofRegulationD,orwhothesellerreasonablybelievescomeswithinanyofsuchcategories,atthetimeofthesaleofthesecuritiestothatperson.Theterm“memberofthefamilyofthepurchaserortheequivalent”includesachild,stepchild,grandchild,parent,stepparent,grandparent,spouseorspousalequivalent,sibling,mother-in-law,father-in-law,son-in-law,daughter-in-law,brother-in-law,orsister-in-lawofthepurchaser,andincludesadoptiverelationships.Theterm“spousalequivalent”meansacohabitantoccupyingarelationshipgenerallyequivalenttothatofaspouse.
DescriptionofIssuer’sSecurities
17. Whatothersecuritiesorclassesofsecuritiesoftheissuerareoutstanding?Describethematerialtermsofanyotheroutstandingsecuritiesorclassesofsecuritiesoftheissuer.
Securities
ClassofSecurity
AmountAuthorized
AmountOutstanding
VotingRights
OtherRights
ClassAMembershipUnits
17,000,100 15,000,000 Yes ClassAUnitsareentitledtopriorityondistributionsorifanduponliquidationwithrespecttotheircapitalaccountbalances.
ClassBMembershipUnits
0 0 No AftersatisfyingClassAUnitcapitalaccountbalances,distributions,includingthoseifanduponliquidation,areallocatedtoallunitholdersratably.
Options,WarrantsandOtherRights
None.
18. Howmaytherightsofthesecuritiesbeingofferedbemateriallylimited,dilutedorqualifiedbytherightsofanyotherclassofsecurities?
Wecurrentlyhavenoconvertibledebt,andcurrentlytherearenowarrants,options,orotherconvertibleinstrumentsoutstanding,whichifexercised,wouldbedilutivetotheinvestorsthatpurchaseClassAUnitsinthisoffering.
19. Arethereanydifferencesnotreflectedabovebetweenthesecuritiesbeingofferedandeachotherclassofsecurityoftheissuer?
TheCompanygrantstoanyinvestorthatparticipatesinthiscrowdfundingoffering,aperpetualwaiverfromtheprovisionsthatlimitandrestricttheabilityofamembertotransferunits,pursuanttoArticle2.2oftheCompany’sOperatingAgreement.ExistingmembersthatownClassAMembershipUnitsarerestrictedbytheprovisionsofArticle2.2.
20. HowcouldtheexerciseofrightsheldbytheprincipalownersidentifiedinQuestion5aboveaffectthepurchasersofSecuritiesbeingoffered?
ZENIILLC(referredtointheseriskfactorsas“Intrommune”,“we”,“us”,“our”orthe“Company”)hastwoManagingMemberswhohaveexclusivecontroloverouractivities.InvestorswillhavethestatusofMembersholdingClassAUnits(“ClassAMembers”)andwillhavenovoiceorcontrolintheday-to-daymanagementorconductoftheaffairsoftheCompany.TheManagingMemberswillhavethesoleandabsoluterightandauthoritytoactforandonbehalfoftheCompanyinconnectionwithallaspectsofourbusiness.
21. Howarethesecuritiesbeingofferedbeingvalued?Includeexamplesofmethodsforhowsuchsecuritiesmaybevaluedbytheissuerinthefuture,includingduringsubsequentcorporateactions.
Comparablesanddiscussionswithnumerouspotentialinvestorswithhealthcareand/orfoodallergyfocus.
22. Whataretheriskstopurchasersofthesecuritiesrelatingtominorityownershipintheissuer?
TheManagingMemberswillhavethesoleandabsoluterightandauthoritytoactforandonbehalfoftheCompanyinconnectionwithallaspectsofourbusiness.TheClassAMemberswillbeboundbyallagreementsmadebytheManagingMembersonbehalfoftheCompany.Accordingly,nopersonshouldinvestunlessheorsheiswillingtoentrustallaspectsofthemanagementoftheCompanytotheManagingMembersandhasevaluatedandissatisfiedwiththeManagingMembers’
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DateofOffering:
Exemption:
SecuritiesOffered:
AmountSold:
UseofProceeds:
DateofOffering:
Exemption:
SecuritiesOffered:
AmountSold:
UseofProceeds:
DateofOffering:
Exemption:
SecuritiesOffered:
AmountSold:
UseofProceeds:
capabilitiestoperformsuchfunctions.
23. Whataretheriskstopurchasersassociatedwithcorporateactionsincluding:
additionalissuancesofsecurities,
issuerrepurchasesofsecurities,
asaleoftheissuerorofassetsoftheissueror
transactionswithrelatedparties?
Theissuanceofadditionalmembershipinterestunitswilldilutetheownershipofthecrowdfundinginvestors.Asaresult,ifweachieveprofitableoperationsinthefuture,ournetincomeperunitwillbereducedbecauseofdilution,andthemarketpriceofourmembershipinterestunits,ifthereisamarketprice,coulddeclineasaresultoftheadditionalissuanceofsecurities.Ifwerepurchasesecurities,sothattheaboveriskismitigated,andtherearefewermembershipunitsoutstanding,wemaynothaveenoughcashavailableformarketingexpenses,growth,oroperatingexpensestoreachourgoals.Ifwedonothaveenoughcashtooperateandgrow,weanticipatethemarketpriceofourmembershipinterestunitswoulddecline.Asaleofourcompanyoroftheassetsofourcompanymayresultinanentirelossofyourinvestment.Wecannotpredictthemarketvalueofourcompanyorourassets,andtheproceedsofasalemaynotbecash,butinstead,unmarketablesecurities,oranassumptionofliabilities.Wemayneedtonegotiatewitharelatedpartyforadditionalcapital.Noassurancecanbegiventhatsuchfundswillbeavailableor,ifavailable,willbeoncommerciallyreasonabletermssatisfactorytous.Evenifsuchfinancingisavailable,itmaybeontermsthataremateriallyadversetoyourinterestswithrespecttodilutionofbookvalue,dividendpreferences,liquidationpreferences,orotherterms.Noassurancecanbegiventhatsuchfundswillbeavailableor,ifavailable,willbeoncommerciallyreasonabletermssatisfactorytous.Therecanbenoassurancethatwewillbeabletoobtainfinancingifandwhenitisneededontermswedeemacceptable.Ifweareunabletoobtainfinancingonreasonabletermswecouldbeforcedtodiscontinueouroperations.Weanticipatethatanytransactionswithrelatedpartieswillbevettedandapprovedbyexecutivesunaffiliatedwiththerelatedparties.
24. Describethematerialtermsofanyindebtednessoftheissuer:
Notapplicable.
25. WhatotherexemptofferingshasZENII,LLCconductedwithinthepastthreeyears?
04/2017
Section4(a)(2)
MembershipUnits
$2,405
Generalandadministrativeexpenses
11/2016
Section4(a)(2)
MembershipUnits
$1,476
Generalandadministrativeexpenses
01/2016
Section4(a)(2)
MembershipUnits
$35,577
Generalandadministrativeexpenses
CPAReviewReport:
26. Wasoristheissueroranyentitiescontrolledbyorundercommoncontrolwiththeissuerapartytoanytransactionsincethebeginningoftheissuer’slastfiscalyear,oranycurrentlyproposedtransaction,wheretheamountinvolvedexceedsfivepercentoftheaggregateamountofcapitalraisedbytheissuerinrelianceonSection4(a)(6)oftheSecuritiesActduringthepreceding12-monthperiod,includingtheamounttheissuerseekstoraiseinthecurrentoffering,inwhichanyofthefollowingpersonshadoristohaveadirectorindirectmaterialinterest:1. anydirectororofficeroftheissuer;2. anypersonwhois,asofthemostrecentpracticabledate,thebeneficialownerof20percentor
moreoftheissuer’soutstandingvotingequitysecurities,calculatedonthebasisofvotingpower;
3. iftheissuerwasincorporatedororganizedwithinthepastthreeyears,anypromoteroftheissuer;or
4. anyimmediatefamilymemberofanyoftheforegoingpersons.
No.
FinancialConditionoftheIssuer
27. Doestheissuerhaveanoperatinghistory?
Yes.
28. Describethefinancialconditionoftheissuer,including,totheextentmaterial,liquidity,capitalresourcesandhistoricalresultsofoperations.
Sinceinception,theCompanyhasfinanceditsoperationsprimarilythroughadvancesfromrelatedparties.AsofDecember31,2017,theCompanyhadamembers’deficitof$192,268.DuringtheyearsendedDecember31,2017and2016,theCompanyincurrednetlossesof$137,567and$52,833,respectively,usedcashinoperatingactivitiesof$58,396and$12,050duringtheyearsendedDecember31,2017and2016,respectively,andhadcurrentliabilitiesinexcessofcurrentassetsby$192,268asofDecember31,2017.TheseconditionsraisesubstantialdoubtabouttheCompany'sabilitytocontinueasagoingconcern.Fromtimetotime,theCompany’smembersandaffiliatedpartiesadvancemoneytofundoperationsandvariousrelatedpersonsandentitieshaveprovidedservicestotheCompany.AsofDecember31,2017and2016,relatedpartypayablestotaled$70,514and$12,313,respectively.Inaddition,WilliamReisacher,MD,arelatedpartyandunitholder,servesasseniorscientificadvisortotheCompanyandaccruescompensationforsuchservicesatarateof$1,000permonth.AsofDecember31,2017and2016,thetotalaccruedcompensationpayabletoDr.Reisacherforsuchservicesis$24,000and$12,000(includedintherelatedpartypayablesdisclosedabove),forresearchanddevelopmentexpensesof$12,000peryearforeachDecember31,2017and2016.FortheyearendedDecember31,2017,generalandadministrativeexpensesamountedto$118,753,anincreaseof$102,108overexpensesof$16,645fortheyearendedDecember31,2016.FortheyearendedDecember31,2017,researchanddevelopmentexpensesamountedto$18,814,adecreaseof$17,374overexpensesof$36,188fortheyearendedDecember31,2016.
FinancialInformation
29. Includethefinancialinformationspecifiedbyregulation,coveringthetwomostrecentlycompletedfiscalyearsortheperiod(s)sinceinceptionifshorter.
Seeattachments:
reviewletter.pdf
30. Withrespecttotheissuer,anypredecessoroftheissuer,anyaffiliatedissuer,anydirector,officer,generalpartnerormanagingmemberoftheissuer,anybeneficialownerof20percentormoreof
theissuer’soutstandingvotingequitysecurities,calculatedinthesameformasdescribedinQuestion6ofthisQuestionandAnswerformat,anypromoterconnectedwiththeissuerinanycapacityatthetimeofsuchsale,anypersonthathasbeenorwillbepaid(directlyorindirectly)remunerationforsolicitationofpurchasersinconnectionwithsuchsaleofsecurities,oranygeneralpartner,director,officerormanagingmemberofanysuchsolicitor,priortoMay16,2016:1. Hasanysuchpersonbeenconvicted,within10years(orfiveyears,inthecaseofissuers,their
predecessorsandaffiliatedissuers)beforethefilingofthisofferingstatement,ofanyfelonyormisdemeanor:1. inconnectionwiththepurchaseorsaleofanysecurity?2. involvingthemakingofanyfalsefilingwiththeCommission?3. arisingoutoftheconductofthebusinessofanunderwriter,broker,dealer,municipal
securitiesdealer,investmentadviser,fundingportalorpaidsolicitorofpurchasersofsecurities?
2. Isanysuchpersonsubjecttoanyorder,judgmentordecreeofanycourtofcompetentjurisdiction,enteredwithinfiveyearsbeforethefilingoftheinformationrequiredbySection4A(b)oftheSecuritiesActthat,atthetimeoffilingofthisofferingstatement,restrainsorenjoinssuchpersonfromengagingorcontinuingtoengageinanyconductorpractice:1. inconnectionwiththepurchaseorsaleofanysecurity?;2. involvingthemakingofanyfalsefilingwiththeCommission?3. arisingoutoftheconductofthebusinessofanunderwriter,broker,dealer,municipal
securitiesdealer,investmentadviser,fundingportalorpaidsolicitorofpurchasersofsecurities?
3. Isanysuchpersonsubjecttoafinalorderofastatesecuritiescommission(oranagencyorofficerofastateperforminglikefunctions);astateauthoritythatsupervisesorexaminesbanks,savingsassociationsorcreditunions;astateinsurancecommission(oranagencyorofficerofastateperforminglikefunctions);anappropriatefederalbankingagency;theU.S.CommodityFuturesTradingCommission;ortheNationalCreditUnionAdministrationthat:1. atthetimeofthefilingofthisofferingstatementbarsthepersonfrom:
1. associationwithanentityregulatedbysuchcommission,authority,agencyorofficer?2. engaginginthebusinessofsecurities,insuranceorbanking?3. engaginginsavingsassociationorcreditunionactivities?
2. constitutesafinalorderbasedonaviolationofanylaworregulationthatprohibitsfraudulent,manipulativeordeceptiveconductandforwhichtheorderwasenteredwithinthe10-yearperiodendingonthedateofthefilingofthisofferingstatement?
4. IsanysuchpersonsubjecttoanorderoftheCommissionenteredpursuanttoSection15(b)or15B(c)oftheExchangeActorSection203(e)or(f)oftheInvestmentAdvisersActof1940that,atthetimeofthefilingofthisofferingstatement:1. suspendsorrevokessuchperson’sregistrationasabroker,dealer,municipalsecurities
dealer,investmentadviserorfundingportal?2. placeslimitationsontheactivities,functionsoroperationsofsuchperson?3. barssuchpersonfrombeingassociatedwithanyentityorfromparticipatinginthe
offeringofanypennystock?
IfYestoanyoftheabove,explain:
5. IsanysuchpersonsubjecttoanyorderoftheCommissionenteredwithinfiveyearsbeforethefilingofthisofferingstatementthat,atthetimeofthefilingofthisofferingstatement,ordersthepersontoceaseanddesistfromcommittingorcausingaviolationorfutureviolationof:1. anyscienter-basedanti-fraudprovisionofthefederalsecuritieslaws,includingwithout
limitationSection17(a)(1)oftheSecuritiesAct,Section10(b)oftheExchangeAct,Section15(c)(1)oftheExchangeActandSection206(1)oftheInvestmentAdvisersActof1940oranyotherruleorregulationthereunder?
2. Section5oftheSecuritiesAct?
6. Isanysuchpersonsuspendedorexpelledfrommembershipin,orsuspendedorbarredfromassociationwithamemberof,aregisterednationalsecuritiesexchangeoraregistered
nationaloraffiliatedsecuritiesassociationforanyactoromissiontoactconstitutingconductinconsistentwithjustandequitableprinciplesoftrade?
7. Hasanysuchpersonfiled(asaregistrantorissuer),orwasanysuchpersonorwasanysuchpersonnamedasanunderwriterin,anyregistrationstatementorRegulationAofferingstatementfiledwiththeCommissionthat,withinfiveyearsbeforethefilingofthisofferingstatement,wasthesubjectofarefusalorder,stoporder,orordersuspendingtheRegulationAexemption,orisanysuchperson,atthetimeofsuchfiling,thesubjectofaninvestigationorproceedingtodeterminewhetherastoporderorsuspensionordershouldbeissued?
8. IsanysuchpersonsubjecttoaUnitedStatesPostalServicefalserepresentationorderenteredwithinfiveyearsbeforethefilingoftheinformationrequiredbySection4A(b)oftheSecuritiesAct,orisanysuchperson,atthetimeoffilingofthisofferingstatement,subjecttoatemporaryrestrainingorderorpreliminaryinjunctionwithrespecttoconductallegedbytheUnitedStatesPostalServicetoconstituteaschemeordeviceforobtainingmoneyorpropertythroughthemailbymeansoffalserepresentations?
ZENII,LLCanswers'NO'toalloftheabovequestions.
OtherMaterialInformation
31. InadditiontotheinformationexpresslyrequiredtobeincludedinthisForm,include:anyothermaterialinformationpresentedtoinvestors;andsuchfurthermaterialinformation,ifany,asmaybenecessarytomaketherequiredstatements,inthelightofthecircumstancesunderwhichtheyaremade,notmisleading.
TheCompany’sprincipalofficeislocatedinspaceleasedbyAllovate,LLC,d/b/aAllovateTherapeutics(“Allovate”),anaffiliateundercommoncontrolwiththeCompany.AsofDecember31,2017,thevalueoftherentandassociatedutilitiesfortheportionofthespaceutilizedbyIntrommuneisdeminimis.TheCompanyenteredanexclusivelicenseagreementwithAllovate,forcertainpatentrightsandassociatedtechnologyrelatedtothecommercialdevelopment,use,andsaleofproductsinthefieldoffoodallergen-specificimmunotherapyforhumanswithfoodallergies.Theagreement’seffectivedateisonthedateofthefirstlicensefeepayment.TheagreementobligestheCompanytothefollowingpayments:•Licenseissuefeeof$2,000,000,payableas10%oftheequityfundingtotheCompanyafterraising$1,000,000andupto$10,000,000,then5%ofequityfundingtotheCompanyonthenext$20,000,000raised,andtheassumptionofa$500,000notepayablebearinginterestat5%commencingDecember14,2015andmaturedNovember27,2017.•Licensemaintenancefeesof$100,000atthefirstanniversaryoftheeffectivedateoftheagreementandincreasingby$100,000annuallythereafter,payableoneachsucceedinganniversaryuntiltheCompanyiscommerciallysellingaproducedlicensedundertheagreement.•Milestonepaymentsuponachievementofvariousregulatoryapprovalsandfundinggoals,includinga$25,000,000milestonepaymentuponreceiptofregulatoryapprovaltosellaproductlicensedundertheagreement.•Royaltypaymentsonnetsales(asdefinedintheagreement).•SublicensefeesonanysublicensefeesandroyaltiesreceivedbytheCompany.•Theroyaltypaymentsandsublicensefeesaresubjecttoacombinedminimumof$500,000fromthefirstcalendaryearofcommercialsalesofaproductundertheagreement.•CertainpatentcostsaretobeobligationsoftheCompany,andtheCompanyisrequiredtoreimburseAllovateforanysuchpatentcostsincurred.OnDecember31,2017,theCompanyandAllovateagreedtoanamendmenttotheagreement,withamendmentsincluding:•Decreasingthelicenseissuefeeto$20dueupontheCompanyreceivingequityfinancingofatleast$10,000,whichinrequiredtooccurbyDecember31,2018.•Increasingtheinterestrateofthe$500,000notepayabletobeassumedbytheCompanyto10%,effectiveNovember27,2017.•Defersa$500,000milestonepaymentuntiltheCompanyhasraisedaggregategrossequityfinancingof$20,000,000.VariousadvisorstotheCompanyhavedeferredpaymentarrangementsthattriggerpaymentuponsecuring$1,000,000offinancing.TheCompanydenotesitsownershipinterestsinmembershipunits,andhasauthorizedtwoclassesofmembershipunits:ClassAUnitsandClassBUnits.TheCompanyhad100,000and97,595ClassAUnitsissuedandoutstandingasofDecember31,2017and2016,respectively.NoClassBUnitshavebeenissuedasofDecember31,2017or2016.ClassAUnitsareentitledtopriorityondistributionsorifanduponliquidationwithrespecttotheircapitalaccountbalances.Aftersatisfying
Governance:
CertificateofFormation:
OperatingAgreement:
Opportunity:
OfferingPageJPG:
PitchDeck:
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ClassAUnitcapitalaccountbalances,distributions,includingthoseifanduponliquidation,areallocatedtoallunitholdersratably.Aftertheissuanceofanindependentaccountant'sreviewreportoftheCompany'sfinancialstatementsfortheyearsendedDecember31,2017and2016,onApril9,2018,theCompanysplititsunits150to1.Asofthedateofthisoffering,15,000,000ClassAMembershipUnitsareoutstanding.OfferingPageVideoTranscript:Peanutallergy,themostcommonfoodallergyinkidshastripledinthepast10years.Familiesdealingwithpeanutallergyoftenliveinfearandmanykidsreportfeelingisolatedfromtheirfriends.TodayherearenoFDAapprovedtreatmentsforpeanutallergy.Here,atIntrommuneTherapeuticswearedevelopingagroundbreakingtoothpastetotreatpeanutallergy-ourtoothpastedeliverspharmaceuticalactiveingredientstothemouth,whichretraintheimmunesystem.Ourresearchpredictsthatovertimetheimmunesystemwilllearntostopattackingpeanutsandallergicreactionswillbecomelesssevere.Justlikeyourregulartoothpaste,ourskeepsteethcleanandfightscavities.WithIntrommune'ssimpletreatmentpeoplewithpeanutallergywillabletolivewithoutfear.OurNewYorkCityteamofexperiencedentrepreneursandresearchers,successfullytestedthetoothpastelastyearandnowwearebeggingsafetyandefficacytestingtoseekFDAApproval.Yoursupportwillallowustoresearch,testandmoveforwardwithasolutionsothatnormaliswithinreachformillionsofpeanutallergysufferers.Forinformationonhowtoinvest,clickhere!
Thefollowingdocumentsarebeingsubmittedaspartofthisoffering:
certificateofformation.pdf
operatingagreement.pdf
offeringpage.jpg
pitchdeck.pdf
OngoingReporting
32. TheissuerwillfileareportelectronicallywiththeSecurities&ExchangeCommissionannuallyandpostthereportonitswebsite,nolaterthan120daysaftertheendofeachfiscalyearcoveredbythereport:
Onceposted,theannualreportmaybefoundontheissuer’swebsiteat:www.intrommune.com
Theissuermustcontinuetocomplywiththeongoingreportingrequirementsuntil:
theissuerisrequiredtofilereportsunderSection13(a)orSection15(d)oftheExchangeAct;
theissuerhasfiledatleastoneannualreportpursuanttoRegulationCrowdfundingandhasfewerthan300holdersofrecordandhastotalassetsthatdonotexceed$10,000,000;
theissuerhasfiledatleastthreeannualreportspursuanttoRegulationCrowdfunding;
theissueroranotherpartyrepurchasesallofthesecuritiesissuedinrelianceonSection4(a)(6)oftheSecuritiesAct,includinganypaymentinfullofdebtsecuritiesoranycompleteredemptionofredeemablesecurities;or
theissuerliquidatesordissolvesitsbusinessinaccordancewithstatelaw.
