Upload
tranmien
View
214
Download
1
Embed Size (px)
Citation preview
The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This document does notconstitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. This document has been prepared forinformational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendation to subscribe for or purchase any security andneither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does not purport to summarize all information that an investor shouldconsider when making an investment decision. It should be read in conjunction with the Offering Documents.
InvestorPresentationJanuary2018
The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This document does notconstitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. This document has been prepared forinformational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendation to subscribe for or purchase any security andneither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does not purport to summarize all information that an investor shouldconsider when making an investment decision. It should be read in conjunction with the Offering Documents.
Nextgenerationtherapeuticsforindicationssuchasatopicdermatitis
StrictlyPrivate&Confidential
2The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
DisclaimerandSafeHarborDisclaimerThis document is based on information provided by Hoth Therapeutics, Inc. (“Hoth” or the “Company”) and other sources the Company believes are reliable.Laidlaw & Company (UK) Ltd., the placement agent, makes no representation or warranty that the information in this document is accurate or complete and isnot responsible for this information. The placement agent has not acted on your behalf to independently verify the information in this document. Nothing inthis document is, or may be relied upon as, a promise or representation by the placement agent as to the past or the future.
The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant andRegistration Rights Agreement. This document does not constitute an offering document. Potential investors or shareholders should not rely on theinformation contained in this document before making an investment decision. This document has been prepared for informational purposes only. Thisdocument is being provided for the sole purpose of providing the recipients with background information about Protea’s business. This document, includingthe information contained in this disclaimer, does not constitute an offer, invitation or recommendation to subscribe for or purchase any security and neitherthe document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does not purport to summarize allinformation that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
The offer to invest in the securities and the sale thereof, discussed herein, has not been registered under the United States Securities Act of 1933, as amended,or any state securities laws. The securities are being offered and sold in reliance on exemptions from the registration requirements of such laws. Thesecurities are being offered and sold only to bona fide residents of states in which such exemption is available, who can meet certain requirements, includingnet worth and income requirements, and who purchase the securities without a view to distribution or resale. By accepting delivery, you acknowledge andagree that all of the information contained herein is of a confidential nature and that this document has been furnished to you by the Company solely for yourconfidential use for the purpose of providing you with background information about Protea’s business. You agree that you will treat such information in aconfidential manner, will not use such information for any purpose other than its intended use, and will not, directly or indirectly, disclose or permit youragents or affiliates to disclose any of such information without the prior written consent of the Company.
In making an investment decision regarding the securities offered by the Company, you must rely on your own examination of the Company and the terms ofthis offering as described in the Offering Documents, including, without limitation, the merits and risks involved. Neither the Company nor the placementagent does or can guarantee that purchase of the securities will result in any economic gain and, to the contrary, it must be stressed that an investment in theCompany involves significant risks and you may suffer the loss of your entire investment.
Safe Harbor StatementThis presentation contains "forward-looking statements" within the meaning of the “safe-harbor” provisions of the private securities litigation reform act of1995. Such statements involve known and unknown risks, uncertainties and other factors that could cause the actual results of the Company to differmaterially from the results expressed or implied by such statements, including changes from anticipated levels of revenues, future national or regionaleconomic and competitive conditions, difficulties in developing the Company’s technology platforms, retaining and expanding the Company’s customer base,fluctuations in consumer spending on the Company’s products and other factors. Accordingly, although the Company believes that the expectations reflectedin such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company has no obligationto update the forward-looking information contained in this presentation.
StrictlyPrivate&Confidential
3The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
• Development stage biopharmaceutical company focused on unique targetedtherapeutics for patients suffering from indications such as atopic dermatitis oreczema
• Proprietary platform technology combines two existing approved drugs enablingreliance on existing safety data for those drugs reducing expected time to marketfrom 10-12 years to 3-4 years
• Strong intellectual property position including issued patents in the United Statesand Europe
• Management team, board of directors and advisors with prominent financialservices and drug development experience
• According to National Eczema Association, estimated U.S. market opportunity foraesthetic dermatology conditions is $2.0 billion
InvestmentHighlights
StrictlyPrivate&Confidential
4The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
• Biofilms are matrices produced by bacterial colonies that shield the colony fromattack by the immune system and make the bacteria up to 1000 times moreresistant to antibiotics
• CDC data indicate that biofilms are implicated in over 2/3 of all skin infections
• Bacteria rely on Zn+2 ions to colonize and build biofilms to protect colonies
Biolexa PlatformTechnologyTopicalagentcombiningchelatingagentwithanantibiotictofightbacterialinfections
StrictlyPrivate&Confidential
5The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
• BioLexa platform technologycombines a chelating agent withan antibiotic to form asynergistic compoundcombination for inhibitingbiofilm formation and fightingbacterial infection
• BioLexa works by using DTPA tochelate the Zn+2 ions necessaryto form bacterial colonies andbiofilms while using gentamicin,a potent antibiotic, to fightexisting bacteria
CombiningChelatingAgentwithanAntibiotic
InterveneHere
Source:Image,BiofilmsinInfections,Dr.TVRAO,MDhttps://slideshare.net/doctorrao/biofilms-2172226
StrictlyPrivate&Confidential
6The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
DevelopmentBackground• Selectelementsofinitialproduct
– Targetbacteria:Staphaureus/Staphepidermidis
– Chelatingagent:CaDTPA– Antibiotic:Gentamicin0.1%
• Developtopicaldosageform– GRAScreamvehicleavailable
• Demonstrateproofofconcept– Selectappropriateanimalmodel– UniversityofMiami,contractforstudy
Biolexa DevelopmentStrategyTopicalcreamandexpandplatformtoincludegelandsprayable formulations
1st GenerationProduct• Immediatereleasetopicallyapplied• Unitdosedelivery• Neutralcreamformulation• 0.1%Gentamicinactiveantibiotic
2nd GenerationProduct• Gelandsprayable• Bio-resorbableocclusionproduct• Multipleantibioticsinbothtopicalandocclusionformats
StrictlyPrivate&Confidential
7The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
BioLexa DevelopmentTimeline
Activity Cost Partner 1Q 2Q 3Q 4Q Yr 2 Yr 3 Yr 4
Non-Clinical $125K UMiami
CMC:formulation,cGMP,stability $300K CMO
Pre-INDandIND $140K Legal,CRO
Phase 2bstudy $1.1M CRO
CMCforPhase 3 $900K CMO
Phase3trial1 $2.5M CRO
Phase 3trial2 $2.5M CRO
NDAprepandsubmission $1,250K CRO
FDAreviewandapproval $215K Reg,CRO
Totalinvestment* $9,015K
*Costsdonotincludeinternaloverhead
Consistentmilestonesexhibitsstrongmomentuminproductdevelopment
StrictlyPrivate&Confidential
8The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
IntellectualPropertyandLicenseTermsSummary
Country Patent Expiration IssueDate Issued Pending
EU Patentcoveringcompositionsandmethods 2028 October2014 ü
US& PCT
Allowedclaimscoveringformulation,manufacture andimpregnationofwounddressings,bandagesandclothing.
Estimated2033 2016
ü
BioLexa LicenseTerms• MasterLicensefromUniversityofCincinnati• Worldwide,exclusivelicensetodevelop,manufactureandsellwithrighttosub-
license• Nomilestones,minimalannuallicensefee• MinimalroyaltytotheUniversity
StrictlyPrivate&Confidential
9The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
Biolexa MarketOpportunity
Indication MedicalNeed TargetPatients US MarketOpportunity(USD)
Eczema andatopicdermatitis
Extend timebetweenflareup 32M1 $9.5B1
Aestheticdermatology
Improvehealing,improvecosmeticoutcomes
8.8M2 $1.9B2
Source:1.AccordingtotheNationalEczemaAssociation,thischronicskinconditionaffectsapproximately32millionAmericans,spending$300perannumperpatientonaverage,representsanapproximate$9.5billionmarketintheU.S.2.TheAmericanSocietyforAestheticPlasticSurgery(ASAPS)17thannualmulti-specialtystatisticaldata
StrictlyPrivate&Confidential
10The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
• By2021,approximately35Mpeoplewillbeaffectedbyeczema• 20%oftheexpectedpopulationwillbechildren• Weassumethatwiththefollowingdosespecifications,revenueprojectionsby
2026willbeapproximately$500M
EczemaUSMarketOpportunityAnalysis
Dosesize 15gramtube
CGS perdose $9.00
Retailperdose $45.00
Wholesale discount 35%
Wholesaleprice/dose $29.25
Doses/patient 6
2021 2022 2023 2024 2025 2026
Patientshare .05% .5% 1.0% 2.5% 5.0% 7.5%
Totaltreatedpatients 17.5K 177.9K 361.3K 916.9K 1,861.1K 2,833.6K
Totaldoses 105,213 1,067,915 2,167,867 5,500,964 11,186,956 17,001,680
Revenueatwholesale $3,077,489 $31,236,313 $63,410,121 $160,903,103 $326,633,461 $497,299,444
Source:NationalEczemaAssociation
StrictlyPrivate&Confidential
11The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
BioLexa FormulationManufacturedusingsimpleprocesscombininggentamicin,DTPAandcreambase
Gentamicinsulfate0.1%
Ca-DTPApowder
GRAS Cream Vehicle BioLexa
• TopicalcreammadeupofGlycerl Stearate/PEG-100Stearate,LanolinAlcohol,MineralOil,Sorbitol70%Solution,andactivecomponents;GentamicinandCa-DTPA,Gentamicin0.1%cream
• Broadspectrumantibioticexhibitingbactericidalactivityagainstbothgram-positiveandgram-negativebacteria
• FDAclearedforbothinternalandexternalapplicationsandprovideshighlyeffectivetopicaltreatmentinprimaryandsecondarybacterialinfectionsoftheskin
StrictlyPrivate&Confidential
12The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
• Eczemaisageneraltermformanytypesofskininflammationincludingatopicdermatitis,whichisthemostcommon
• Atopicdermatitisisachronicinflammatorydiseaseoftheskin,oftenreferredtoas‘childhoodeczema’involvingthebreakdownoftheskinbarrier
• Atopicdermatitisisthemostcommonformofpediatriceczema
• InastudyconductedbyDr.HerbertAllenofDrexelUniversityskinswabs,scrapings,andbiopsiesfromADpatients’inflamedskinwerecomparedtocontrolsampleswhereskinwasunaffected
– AllsamplestakenfromskinaffectedbyADhadmulti-drugresistantStaph(aureusandepidermidis)andallwerepositiveforbiofilmformation
EczemaDiseaseOverviewBiofilmsandstaphaureusinfectionscontributetoEczema
StrictlyPrivate&Confidential
13The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
• Staphaureusmakesup20%ofthebacteriaonskinand40%onlesions
• Exposuretowaterorsaltandslightperspirationpromptsbiofilmformationandclogsthesweatductswhichtriggersandimmuneresponse
• Immuneresponsecombinedwithgenedeficiencyresultsinitchingandrash
BiofilmsinEczema
Source:1.http://www.easeeczema.org/erc/symptoms_of_eczema.htm
StrictlyPrivate&Confidential
14The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
• ThirtyfivemillioneczemaandatopicdermatitispatientsintheUSand20%arepediatric1
• Currenttreatmentsforeczemaincludetopicalsteroids,OTCmoisturizers,oatmealbaths– Avoidingirritantsandsoapmayalleviatesymptoms
• Currenttreatmentslackefficacyinreducingsymptomsofeczema– Oftenmessyandexpensiveandcauseundesirablesideeffects
• Productsindevelopmenthaveseveralshortcomings– Systemicdeliverythatmayleadtopotentialsystemicsafetyrisks– Intendedtoonlytreatsymptomspostoccurrence– ComplexMOAsandcostly
UnmetMedicalNeedExistingtreatmentsforeczemaaremessy,expensive
Source:1.GrandRoundsNationCMEonReachMD.ThisistheNationalJewishHealthandProva Educationsegment,AssessingtheCurrentTreatmentofAtopicDermatitis:UnmetNeeds.ThefacultyforthisactivityisDonaldLeung,MD,PhD,ProfessorandHeadoftheDivisionofPediatricAllergyand ImmunologyintheDepartmentofPediatricsattheNationalJewishMedicalCenterinDenver,CO2.NationalEczemaInstitute– remainderofbulletsonslide
StrictlyPrivate&Confidential
15The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
• Topicallocalizeddelivery• Intendedtodelayorpreventflare-upsofsymptoms• Abilitytousejointlywithothertreatmentstomaximizepatientbenefit
BioLexa Solutions
StrictlyPrivate&Confidential
16The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
KeyPeople
Name&Title Background
RobbKniePresidentandCEO,Director
• GeneralpartnerofLifleline Ind.Inc,since1995• 20+yearsofequitymarketsexperience,semiconductorandtelecommunicationsanalystPAWPartners
• BoardpositionswithNASDAQlistedcompaniesandmanagementpositionswithAmericanExpressFinancialAdvisors
VadimMatsDirector
• CFO ofPointCapital,Inc.,andCFOofFWSCapitalLtd.• PreviouslyCFOofWhalehaven GroupofFunds,AssistantControlleratEtonParkCapitalManagement,andSeniorFundAccountantatBankofNewYorkMellon
• B.S.BusinessAdministrationcumlaude,M.S.Accounting,FinancefromZicklinSchoolofBusiness,BernardBaruchCollege
• CAIACharterholder andCPA
KennethRiceDirector
• PresidentandCFOofLikeMinds,Inc.• 25+yearsofexperienceinoperations,finance, marketingandsalesandbusinessdevelopmentinprivateandpubliclifesciencescompanies
• PreviouslyEVP,CFOandinhousecounselofAlseres Pharmaceuticals,Inc.,andwasalsowithAderis Pharmaceuticalsinasimilarcapacity
AnthonyHayesDirector
• President,CEOandDirectorofSpherix,Inc.,(Nasdaq:SPEX)• FounderandmanagingmemberofAtwaterPartnersofTexasLLCandformerpartneratNelsonMullinsRiley&ScarboroughLLP
• B.A.Economics,MaryWashingtonCollege,J.D.TulaneUniversitySchoolofLaw
StrictlyPrivate&Confidential
17The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
KeyPeople
Name&Title Background
Dr.Andrew HerrScientificAdvisoryBoard
• Dr. AndrewHerr,PhD,isanassociateprofessorintheDivisionofImmunobiology andCenterforSystemsImmunology,withanaffiliateappointmentintheDivisionofInfectiousDiseasesatCincinnatiChildren'sHospitalwithintheUCDepartmentofPediatrics.Dr.HerrcompletedhisthesisworkinmolecularbiophysicsfromWashingtonUniversity in St.Louis,andcompletedhispostdoctoralworkinstructuralimmunologyatthe CaliforniaInstituteofTechnology asaDamonRunyonResearchFellow.Hewasrecruitedtothe UniversityofCincinnati CollegeofMedicineasanOhioEminentScholarinStructuralBiologybeforemovingtoCincinnatiChildren'sHospital.
Dr.Richard GransteinScientificAdvisoryBoard
• RichardD.Granstein,M.D.istheGeorgeW.Hambrick,Jr.ProfessorandChairmanoftheDepartmentofDermatology.Dr.Granstein obtainedhisundergraduateeducationatthe MassachusettsInstituteofTechnology andhismedicaleducationattheUCLASchoolofMedicine.Aftercompletinghisinternshipin1979,hetrainedindermatologyatthe Massachusetts GeneralHospital.AsaResearchFellow,Dr.Granstein studiedimmunologyandtumorbiologyattheNationalCancerInstitute-FrederickCancerResearchFacilityandat HarvardMedicalSchool.Dr.Granstein joinedthefacultyoftheDepartmentofDermatologyat HarvardMedicalSchool andthe Massachusetts GeneralHospitalin1984.In1995heleft Harvard tobecomeChairmanoftheDepartmentofDermatologyatthe WeillMedicalCollegeofCornellUniversity andDermatologist-in-ChiefattheNewYork-Presbyterian/WeillCornellMedicalCenter.
StrictlyPrivate&Confidential
18The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
PlatformCompanies
Source:CapitalIQ,August10,2017http://fortune.com/2017/03/28/fda-eczema-drug-sanofi-regeneron/
Company TickerSymbolMarketCap$mm
RegeneronPharmaceuticals,Inc.
NASDAQ:REGN 50,537
Teligent,Inc. NASDAQ:TLGT 361.5
Pfizer,Inc. NYSE:PFE 199,624
Marketprecedentsupportspremiumvaluefordermatologyfocusedcompanies
StrictlyPrivate&Confidential
KeyCompanies • March2017– SanofiandRegeneronwinFDAapprovalfordupilumab(brandnameDupixent)totreatskinrashatopicdermatitis,akaeczema– Dupixent haspotentialfor$3Bin
annualsales• Teligent manufacturesandmarkets
generictopicalproductsintheUSandCanadaforeczema,dermatitis,psoriasis
• PfizeracquiredAnacor andsecuredmarketshareingrowingmarketforeczematreatments
• Limitedpubliccompanyexposuretoeczema,dermatitisindicationspresentsopportunity
StrictlyPrivate&Confidential
19The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
NotableTransactionsAcquisitionactivitycanbeasignificantdriverofvaluecreation
Source(s):1.http://www.pfizer.com/news/press-release/press-release-detail/pfizer_to_acquire_anacor;2.http://www.nytimes.com/2016/05/17/business/dealbook/pfizer-to-acquire-anacor-pharmaceuticals-for-5-2-billion.html;3.http://www.marketwatch.com/story/4-things-to-know-about-pfizers-52-billion-acquisition-target-anacor-2016-05-16;3.http://newsroom.mylan.com/2016-05-13-Mylan-to-Acquire-Renaissances-Leading-Topicals-Focused-Specialty-and-Generics-Business;4.http://www.genengnews.com/gen-news-highlights/allergan-acquires-topokine-therapeutics-for-85m-upfront/81252646/;5.http://www.genengnews.com/gen-news-highlights/leo-pharma-buys-astellas-dermatology-business-for-725m/81251969/
• Large pharmaceutical companies such as Pfizer recognize need for safe and noveltreatments in dermatology indications
• Attractive revenue potential for acquirers that is represented by a large andgrowing patient population with atopic dermatitis and eczema
AcquiredCompany
Acquirer TransactionSize Date TransactionDetails
AnacorPharmaceuticalsInc.
Pfizer,Inc.(NYSE:PFE)
$5.2B 5/13/2016 55% premiumoverAnacor sharepriceAnacor leadproduct,Crisaborole,topicaltreatmentformildtomoderateatopicdermatitis
RenaissanceAcquisitionHoldings,LLC
MylanN.V. $950M pluscontingentpaymentsupto$50M
5/13/2016 Announces acquisitionoftopicals-focusedspecialtyandgenericsbusiness
TopokineTherapeutics,Inc.
Allerganplc(NYSE:AGN)
$85Mupfrontpayment
4/22/2016 Topokine specializesintopicalcosmeticdermatology
Astellas Pharma,Inc. LEOPharma,Inc. $725M 11/12/2015 LEOPharmaacquiresAstellas’dermatologybusiness
StrictlyPrivate&Confidential
20The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
DevelopmentStrategyandRegulatoryPathway505(b)(2)strategyreducesdevelopmenttimeandcost
Regulation Description TimeNeeded Explanation
505(b)(1)NDA Newdrug 8-12years
Extensivenon-clinicalandclinicalstudiestodemonstratesafetyandefficacy ofagivendrugforthetargetindication.Significantdatarequirementsresultinlongdevelopmentcyclesandhighcosts
505(j)ANDA Genericdrug 1-2 years
Anabbreviatedapplicationfora“metoo”drugcontainingonlybioavailability/bioequivalencedatacomparingtheproposedproducttotheinnovatorproduct
505(b)(2)NDA
Newdrugcontaining
similaractiveingredient(s)as
previouslyapproveddrug
3years
Modifiedversionofapreviously approvedproduct(s)thatrequiresadditionalnon-clinicalandclinicaltestingtodemonstratesafetyandefficacy.However,sponsorsareallowedtorelyonFDA”sfindingofsafetyandefficacyforthepreviouslyapprovedreferencedrug(s) therebydramaticallyshorteningtimeframesandloweringcosts
StrictlyPrivate&Confidential
21The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
• Development stage biopharmaceutical company focused on unique targetedtherapeutics for patients suffering from indications such as atopic dermatitis oreczema
• Proprietary platform technology combines two existing approved drugs enablingreliance on existing safety data for those drugs reducing expected time to marketfrom 10-12 years to 3-4 years
• Strong intellectual property position including issued patents in the United Statesand Europe
• Management team, board of directors and advisors with prominent financialservices and drug development experience
• According to National Eczema Association, estimated U.S. market opportunity foraesthetic dermatology conditions is $2.0 billion
InvestmentHighlights
StrictlyPrivate&Confidential
22The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
APPENDIX
StrictlyPrivate&Confidential
23The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
CompletedIn-VivoStudyOverview
• Demonstrateinarobustporcinedeeppartialthicknesswound“challenge”modelthatwhenCa-DTPAiscombinedwithGentamicin0.1%Staphaureus biofilmformationispreventedandplanktonicbacteriaareeliminated
• StudyconductedatUniversityofMiamiMillerSchoolofMedicineintheLaboratoryofDr.SteveDavisunderthedirectionofDr.RobertKirsner
StrictlyPrivate&Confidential
24The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
• Two(2)youngfemaleYorkshire/landraceswine• Forty-four(44)woundsperanimal• EachwoundinoculatedwithStaph aureus 106
• Multiplearms:– Vehicle– Untreated– VaryingconcentrationsofDTPAalone– Gentamicin0.1%alone– BioLexa creamwithvaryingdosesofDTPA
• Atconclusion:collectsamples,measurebiofilmandplanktonicbacteria
In-VivoStudyDesign
Time0 Time+24h Time+48h
• CultureStaph• Inoculate• Initialtreatment• occlude
• Secondtreatment
• Collectsamples• Culture• Measure
StrictlyPrivate&Confidential
25The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
In-vivoPorcinepartialthicknesswoundstudy
EitherAloneNotAdequate CombinationWorksBest
DTPA alone
Gentamicin alone Combination reduced
bacteria below LOD
Gentamicin alone marginally effective but combination far more so
SummaryResults
StrictlyPrivate&Confidential
26The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
• Non-clinical: • Stability studies from cGMP vendor• Porcine study to include systemic absorption measurements and wound closure rates• Guinea pig study for local irritation
• Clinical: • Two possible programs:
• Flare prevention in eczema• Outcome management in post-laser ablation
• Both initial programs utilize the same drug product• Additional indications to be pursued under sNDA provisions and/or 505(b)(2) depending on label and dosage form
KeyDevelopmentInformation
• FDA determination of safety and efficacy for gentamicin including Basis of Approval
• Published literature documenting safety and toxicity profile of gentamicin
• Published literature documenting safety and toxicity profile of DTPA
Key Data in IND
• Vehicle: GRAS components• DTPA: excipient concentration
limited to FDA levels in inactive ingredient list
• Gentamicin: 0.1% concentration as per long-approved product
Product Composition
• Utilize cGMP master vendor for:• Analytical methods development• Optimizing current cream
formulation• Developing a new and
proprietary cream formulation• Stability and shelf life
optimization• Production of cGMP batches• Full documentation set
Formulation and cGMP
BioLexa Clinical and Non-Clinical Development
StrictlyPrivate&Confidential
27The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
EczemaPhase2Development
Phase2b– Safety
Design • Double-blind,placebocontrolledstudytoevaluatethesafetyandefficacyoftopicalBioLexa Preparationinpatientswithatleasta2yearhistoryofEczemasymptom flare-ups.Allsubjectswillbetheirowncontrol
Sample size • 100pediatric subjects.Eachsubjecttoreceiveactiveproductononebodyareaandplaceboonanother
TreatmentSchedule • Oncedailytopical applicationdirectlyonskin,1mmthicknessfor2weekdurationofstudy
Endpoint 1 • Safety
Endpoint2 • Timetosymptomflare-up
Centers • 3
Inclusion • Pediatricsubjectswithatleast2yearhistoryofeczemasymptomsonmultiplebodyparts
Exclusion • Asperindication
Duration • 14daysactivephase
StrictlyPrivate&Confidential
28The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
EczemaPhase3Development
Phase 3PivotalStudy Phase3 ConfirmatoryStudy
Design • Double-blind,placebocontrolledstudytoevaluatethesafetyandefficacyoftopicalBioLexaPreparation inpatientswithrecurringeczemasymptoms
• Double-blind,placebocontrolledstudytoevaluatethesafetyandefficacyoftopicalBioLexaPreparation inpatientswithrecurringeczemasymptoms
Sample size • 150• 150 placebo• 150 active
• 150• 150 placebo• 150 active
Statisticalhypothesis • Timetosymptomoccurrenceimproved versusplacebo • Timetosymptomoccurrenceimproved versusplacebo
TreatmentSchedule • As perphase2bresults • As perphase2bresults
Endpoint 1 • Timetosymptomoccurrenceimproved versusplacebo • Timetosymptomoccurrenceimproved versusplacebo
Endpoint2 • TBD • TBD
Endpoint3 • TBD • TBD
Centers • 10 • 10
Inclusion • Patientswithatleast2yearhistoryofrecurring eczemasymptoms
• Patientswithatleast2yearhistoryofrecurring eczemasymptoms
Exclusion • Asperindication • Asperindication
Duration • 21daysactivephase • 21daysactivephase
StrictlyPrivate&Confidential
29The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
ECZEMAOPPORTUNITYALONE– PROGRAMVALUATION
$000 2016-20 2021 2022 2023 2024 2025 2026
Revenueatwholesale
n/a $3,077 $31,236 $63,410 $160,903 $326,633 $497,299
CGS n/a ($947) ($9,611) ($19,510) ($49,509) ($100,503) ($153,015)
GrossMargin n/a $2,130 $21,625 $43,900 $111,394 $226,130 $344,284
Royalties n/a ($200) ($2,030) ($4,121) ($10,458) ($21,231) ($32,324)
Development ($9,015)
G&A ($3,160) ($1,000) ($2,186) ($4,438) ($11,263) ($22,864) ($34,811)
Marketing& Sales ($500) ($923) ($9,370) ($19,023) ($48,271) ($97,990) ($149,190)
PTP ($12,675) $7 $8,039 $16,318 $41,402 $84,045 $127,959
Taxes n/a n/a ($3,215) ($6,526) ($16,561) ($33,618) ($51,184)
ATP ($12,675) $7 $4,824 $9,792 $24,841 $50,427 $76,775
Terminal Value(3x) $1,491,898
TotalCashflows ($12,675) $7 $4,824 $9,792 $24,841 $50,427 $1,568,673
Probability 95% 50% 50% 50% 50% 50% 50%
Risk Adjusted ($12,041) $4 $2,412 $4,896 $12,420 $25,213 $784,336
NPVat30% $43,216
StrictlyPrivate&Confidential
30The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
AestheticDermatology
Indication AnnualUSProcedures EstimatedProcedureRevenues(USD)
EstimatedUSBioLexaMarket(USD)
Laserskinresurfacing(laserdermalablation) 2.4M $5.3B $480M
Skincancer 3.0M $4.5B $450M
Acnescar repair 2.0M $2.0B $300M
Cosmeticplasticsurgery 1.4M $7.0B $750M
• Postprocedureinfectionrisk:• 4-6%ofpatientsundergoingaestheticdermatologyproceduresdevelopinfectionsandover40%oftheseinfectionsinvolveStaph
aureus• Forelectiveprocedures,post-procedureinfectiontreatmentisanaddedcosttothepatientthattheirinsurancewilllikelynot
reimburse• Timetohealing:
• Infectionsslowdownskinrepairandthereforeincreasinghealingtime• Infectionsoftenresultinsub-parskinregenerationpotentiallyjeopardizingtheoutcomesoftheaestheticprocedure• Typicaltimetocompleteclosureis10-15dayspost-procedure• Accelerationofcompleteclosureby2-3daysresultsinhighstatisticaldifferencesbetweentreatmentgroups
RevenueDrivers
BioLexa’sabilitytofightbacterialgrowthwillenabletheinnateimmunesystemtofocusonhealingqualityratherthanfightingpost-procedureinfection.
BioLexa willreducepost-procedureinfections,acceleratehealingandimproveclinicaloutcomesforpatientsundergoingaestheticdermatologyprocedures
StrictlyPrivate&Confidential
31The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
• LaserAblationpatientshave4-6%overallpost-procedureinfectionrates.• Infectionsdisruptoverallhealingtimeandimpactcosmeticoutcomes• Typicaltimetocompleteclosureis10-15dayspost-procedure• Accelerationofcompleteclosureby2-3daysresultsinhighstatisticaldifferences
betweentreatmentgroups• BioLexa’s modulationofbacterialgrowthwillenabletheinnateimmunesystemto
focusonhealingqualityinsteadoffightingpost-procedureinfection
LaserDermalAblation
StrictlyPrivate&Confidential
32The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
LaserAblationPhase2DevelopmentProgram:2DistinctTrials
Phase2a– PILOTSTUDY Phase2b– DOSERANGING
Design • Double-blind,placebocontrolledpilotstudytoevaluatethesafetyandefficacyoftopicalBioLexa Preparation inpatientsundergoingcarbondioxidelaserablationoftheface– 2a
• Double-blind,placebocontrolleddose-rangingstudytoevaluatethesafetyandefficacyoftopicalBioLexaPreparationinpatientsundergoingcarbondioxidelaserablationoftheface– 2b
Sample size • 12• 6PLA• 6active
• 60• 20 PLA• 20activeoncedailyfor5days• 20activeeveryotherdayfordurationofstudy
Statisticalhypothesis • Descriptivestatistics • TBD fromphase2a• Deltaintime-to-healing,incidenceofinfection,cosmetic
outcomes
TreatmentSchedule • Oncedailytopical applicationdirectlyoninjuredarea,1mmthicknessfordurationofstudy
• Oncedailytopical applicationdirectlyoninjuredarea,1mmthicknessfordurationofstudy
• Oncedailytopical applicationdirectlyoninjuredarea,1mmthicknessforinitial5daysafterlaserablation
Endpoint 1 • Adverse events • Time-to-healing, cosmeticoutcomes
Endpoint2 • Time-to-healing • Incidenceofinfection
Endpoint3 • Incidence ofinfection • Adverseevents
Centers • 2 • 4-6
Inclusion • Pts.Undergoingcarbon-dioxidelaserablation • Pts.Undergoingcarbon-dioxidelaserablation
Exclusion • Asperindication • Asperindication
Duration • 21daysactivephase• 6weekcontrolvisit(safetyoutcomes)
• 21daysactivephase• 6weekcontrolvisit(cosmeticoutcomes)
StrictlyPrivate&Confidential
33The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
LaserAblationPhase3Development
Phase 3PivotalStudy Phase3 ConfirmatoryStudy
Design • Double-blind,placebocontrolledstudytoevaluatethesafetyandefficacyoftopicalBioLexapreparation inpatientsundergoingcarbondioxidelaserablationoftheface
• Double-blind,placebocontrolledstudytoevaluatethesafetyandefficacyoftopicalBioLexapreparation inpatientsundergoingcarbondioxidelaserablationoftheface
Sample Size • 300• 150 PLA• 150 active
• 300• 150 PLA• 150 active
StatisticalHypothesis
• Cosmetic outcomesimprovedvs.PLAaftermonth3and6(FitzpatrickWrinkleScale)
• Cosmetic outcomesimprovedvs.PLAaftermonth3and6(FitzpatrickWrinkleScale)
TreatmentSchedule
• As perphase2bresults • As perphase2results
Endpoint 1 • Cosmetic outcomesimprovedvs.PLAaftermonth3and6(FitzpatrickWrinkleScale)
• Cosmetic outcomesimprovedvs.PLAaftermonth3and6(FitzpatrickWrinkleScale)
Endpoint2 • TBD • TBD
Endpoint3 • TBD • TBD
Centers • 10-20 • 10-20
Inclusion • Pts.Undergoingcarbon-dioxidelaserablation • Pts.Undergoingcarbon-dioxidelaserablation
Exclusion • Asperindication • Asperindication
Duration • 21daysactivephase• 6weekcontrolvisit(safetyoutcomes)
• 21daysactivephase• 6weekcontrolvisit(cosmeticoutcomes)
StrictlyPrivate&Confidential
34The Offering Documents consist of the Private Placement Memorandum, Unit Purchase Agreement, Subscription Agreement, Form of Warrant and Registration Rights Agreement. This documentdoes not constitute an offering document. Potential investors or shareholders should not rely on the information contained in this document before making an investment decision. Thisdocument has been prepared for informational purposes only. This document, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendationto subscribe for or purchase any security and neither the document, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does notpurport to summarize all information that an investor should consider when making an investment decision. It should be read in conjunction with the Offering Documents.
OverallDevelopmentTimelineandCost:LaserDermalAblation
Activity Cost Partner 1Q 2Q 3Q 4Q Year2 Yr.3 Yr.4
CMC:formulation,cGMP,stability $250K CMO
Pre-INDandIND $125K Legal,CRO
Phase2a PilotStudy $200K CRO
Phase2bdoseranging $500K CRO
CMCforPhase 3 $750K CRO
Phase3trial1 $2M CRO
Phase 3trial2 $2M CRO
NDAprepandsubmission $750K CRO
FDAreviewandapproval $150K Reg,CRO
Totalinvestment* $6.275M
*Costsdonotincludeinternaloverhead
DevelopmentofBioLexainlaserdermalablationwillcostapproximately$6.3M.FDAapprovalinfirstindicationisplannedfor3yearsfromstart.