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BioRestorative Therapies(BRTX) - 2019 Q4 - Annual Report
BRTXBioRestorative Therapies(BRTX)2021-03-17 21:56

Financing and Funding - The company received aggregate equity and debt financing of 1,658,500and1,658,500 and 10,888,339 respectively during the year ended December 31, 2019[21]. - The company anticipates requiring approximately 12,000,000infinancingtocommenceandcompleteaPhase2clinicaltrialforBRTX−100andapproximately12,000,000 in financing to commence and complete a Phase 2 clinical trial for BRTX-100 and approximately 45,000,000 in further funding for additional clinical trials[43]. - The company received debtor-in-possession financing of 1,189,413duringitsChapter11reorganization[26].−Thecompanyiscurrentlyseekingvariousfinancingalternativestosupportfutureoperations,includingapotentialloanfromAuctusFund,LLC[209].ClinicalTrialsandProductDevelopment−ThecompanyplanstocommenceaPhase2clinicaltrialforBRTX−100inthethirdquarterof2021,pendingnecessaryfunding[33].−TheFDAauthorizedaPhase2clinicaltrialforBRTX−100inFebruary2017,withplanstocommencethetrialinQ32021,pendingnecessaryfunding[49][64].−ThePhase2clinicaltrialwillinvolve99patientsrandomized2:1forBRTX−100tocontrol,withaprimaryefficacyendpointat12monthsfocusingonfunctionimprovementandpainreduction[65].−ThecompanyanticipatesbeginningpreclinicalanimalstudiesforitstreatmentprotocolbyQ32021,pendingnecessaryfinancing[95].−ThecompanyispursuingitsDisc/SpineProgramwithitsleadcelltherapycandidateBRTX−100,havingreceivedFDAauthorizationtocommenceaPhase2clinicaltrial[201].ResearchandDevelopment−Thecompanyhasestablishedalaboratoryfacilitytofurtherdevelopcellular−basedtreatmentsandstemcell−relatedintellectualproperty[42].−Thecompanyhasenteredintomultipleresearchagreements,includinga1,189,413 during its Chapter 11 reorganization[26]. - The company is currently seeking various financing alternatives to support future operations, including a potential loan from Auctus Fund, LLC[209]. Clinical Trials and Product Development - The company plans to commence a Phase 2 clinical trial for BRTX-100 in the third quarter of 2021, pending necessary funding[33]. - The FDA authorized a Phase 2 clinical trial for BRTX-100 in February 2017, with plans to commence the trial in Q3 2021, pending necessary funding[49][64]. - The Phase 2 clinical trial will involve 99 patients randomized 2:1 for BRTX-100 to control, with a primary efficacy endpoint at 12 months focusing on function improvement and pain reduction[65]. - The company anticipates beginning preclinical animal studies for its treatment protocol by Q3 2021, pending necessary financing[95]. - The company is pursuing its Disc/Spine Program with its lead cell therapy candidate BRTX-100, having received FDA authorization to commence a Phase 2 clinical trial[201]. Research and Development - The company has established a laboratory facility to further develop cellular-based treatments and stem cell-related intellectual property[42]. - The company has entered into multiple research agreements, including a 250,000 initial payment and up to 525,000fromPfizerforajointstudyonhumanbrownadiposecellmodels[85].−ThecompanyhasestablishedalaboratoryinMelville,NewYork,forresearchandpotentialproductionofcell−basedproductcandidates[98].−ThecompanyhasenteredintoaResearchandDevelopmentAgreementwithRohtoPharmaceuticalCo.,Ltd.andaResearchAgreementwithPfizer,focusingonstemcelltechnologies[108].MarketPotentialandCompetition−Thecompanyhasidentifiedthatnearly25millionAmericanadultssufferfromchroniclowerbackpain,withapproximately12milliondiagnosedwithdiscdegeneration[46].−ThetotalannualhealthcareandlostproductivitycostsintheU.S.relatedtopainareestimatedtobe525,000 from Pfizer for a joint study on human brown adipose cell models[85]. - The company has established a laboratory in Melville, New York, for research and potential production of cell-based product candidates[98]. - The company has entered into a Research and Development Agreement with Rohto Pharmaceutical Co., Ltd. and a Research Agreement with Pfizer, focusing on stem cell technologies[108]. Market Potential and Competition - The company has identified that nearly 25 million American adults suffer from chronic lower back pain, with approximately 12 million diagnosed with disc degeneration[46]. - The total annual healthcare and lost productivity costs in the U.S. related to pain are estimated to be 600 billion, highlighting the potential market for BRTX-100[74]. - The company faces competition from larger pharmaceutical and biotechnology firms, which have significantly greater resources, making it challenging to predict market entry timelines for competing products[117]. Financial Performance - For the year ended December 31, 2019, the company generated revenues of 130,000,anincreasefrom130,000, an increase from 111,000 in 2018, representing a growth of approximately 17.1%[212]. - Total operating expenses for 2019 were 8,562,005,comparedto8,562,005, compared to 7,758,652 in 2018, indicating an increase of about 10.4%[211]. - The net loss for 2019 was 14,647,890,comparedtoanetlossof14,647,890, compared to a net loss of 12,517,803 in 2018, reflecting an increase in losses of approximately 17.0%[211]. - The accumulated deficit as of December 31, 2019, was 78,570,146,withastockholders′deficitof78,570,146, with a stockholders' deficit of 12,776,146 and a working capital deficiency of 13,651,716[204].RegulatoryEnvironment−ThecompanyissubjecttostringentFDAregulationsregardingthedevelopmentandmarketingofitsstemcellproducts,whichmayrequiresignificantresourcestocomplywithifnotclassifiedunderHCT/Pregulations[126][129].−TheFDArequirestwoadequateandwell−controlledPhase3clinicaltrialstodemonstratetheefficacyofaninvestigationaldrugorbiologic[142].−TheFDAmayrequireadditionalPhase4clinicaltrialsafteraproductisapprovedtoconfirmeffectivenessandprovidesafetyinformation[144].−TheapprovalprocessforaPMAcouldtakeonetofouryears,withnoguaranteeofultimateclearanceorapproval[163].IntellectualProperty−ThecompanyhasobtainedfourUnitedStatespatentsandsevenforeignpatentsrelatedtoitsThermoStemProgram[41].−ThecompanyhasmultiplepatentsrelatedtoitsThermoStemProgram,includingissuedpatentsintheUS,Australia,Japan,andEurope[93][94].−Thecompanyhassecuredregistrationsformultipletrademarks,includingapublishedapplicationforthetrademarkBRTX,whichiscrucialforprotectingitsproprietarytechnology[108][109].EmployeeandOperationalInformation−Thecompanycurrentlyhassixfull−timeemployeesandbelievesemployeerelationsaregood[182].−Theprincipalexecutiveofficesandlaboratoryoccupy6,800squarefeetofspaceunderaleaseexpiringinDecember2024,withannualbaserentalrangingfrom13,651,716[204]. Regulatory Environment - The company is subject to stringent FDA regulations regarding the development and marketing of its stem cell products, which may require significant resources to comply with if not classified under HCT/P regulations[126][129]. - The FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate the efficacy of an investigational drug or biologic[142]. - The FDA may require additional Phase 4 clinical trials after a product is approved to confirm effectiveness and provide safety information[144]. - The approval process for a PMA could take one to four years, with no guarantee of ultimate clearance or approval[163]. Intellectual Property - The company has obtained four United States patents and seven foreign patents related to its ThermoStem Program[41]. - The company has multiple patents related to its ThermoStem Program, including issued patents in the US, Australia, Japan, and Europe[93][94]. - The company has secured registrations for multiple trademarks, including a published application for the trademark BRTX, which is crucial for protecting its proprietary technology[108][109]. Employee and Operational Information - The company currently has six full-time employees and believes employee relations are good[182]. - The principal executive offices and laboratory occupy 6,800 square feet of space under a lease expiring in December 2024, with annual base rental ranging from 153,748 to $173,060[185].