0001571934--12-312023Q2falseSynaptogenix, Inc.P3YP30D4110000001571934us-gaap:MeasurementInputExpectedTermMembersnpx:ConsultingAgreementWithKatalystSecuritiesLlcMember2023-06-300001571934us-gaap:MeasurementInputExpectedTermMembersnpx:ConsultingAgreementWithGpNurmenkariIncMember2023-06-300001571934us-gaap:MeasurementInputExpectedDividendRateMembersnpx:ConsultingAgreementWithKatalystSecuritiesLlcMember2023-06-300001571934us-gaap:MeasurementInputExpectedDividendRateMembersnpx:ConsultingAgreementWithGpNurmenkariIncMember2023-06-300001571934us-gaap:MeasurementInputRiskFreeInterestRateMember2023-06-300001571934us-gaap:MeasurementInputPriceVolatilityMember2023-06-300001571934us-gaap:MeasurementInputExpectedTermMember2023-06-300001571934us-gaap:MeasurementInputExpectedDividendRateMember2023-06-300001571934us-gaap:MeasurementInputRiskFreeInterestRateMembersnpx:November2022PrivatePlacementMember2022-12-310001571934us-gaap:MeasurementInputExpectedTermMembersnpx:November2022PrivatePlacementMember2022-12-310001571934us-gaap:MeasurementInputExpectedDividendRateMembersnpx:November2022PrivatePlacementMember2022-12-310001571934snpx:MeasurementInputEstimatedEquityVolatilityMembersnpx:November2022PrivatePlacementMember2022-12-310001571934us-gaap:RestrictedStockMemberus-gaap:MeasurementInputRiskFreeInterestRateMembersnpx:ConsultingAgreementWithSherwoodVenturesLlcMember2022-11-300001571934us-gaap:RestrictedStockMemberus-gaap:MeasurementInputPriceVolatilityMembersnpx:ConsultingAgreementWithSherwoodVenturesLlcMember2022-11-300001571934us-gaap:MeasurementInputRiskFreeInterestRateMembersnpx:AdvisoryAgreementsMember2022-11-220001571934us-gaap:MeasurementInputPriceVolatilityMembersnpx:AdvisoryAgreementsMember2022-11-220001571934us-gaap:MeasurementInputExpectedDividendRateMembersnpx:AdvisoryAgreementsMember2022-11-220001571934snpx:AdvisoryAgreementsMember2023-06-300001571934snpx:November2022PrivatePlacementMember2022-12-310001571934us-gaap:RetainedEarningsMember2023-03-310001571934us-gaap:PreferredStockMember2023-03-310001571934us-gaap:CommonStockMember2023-03-310001571934us-gaap:AdditionalPaidInCapitalMember2023-03-3100015719342023-03-310001571934us-gaap:RestrictedStockMembersnpx:ConsultingAgreementWithSherwoodVenturesLlcMember2022-11-012022-11-3000015719342023-08-102023-08-1000015719342023-07-132023-07-130001571934us-gaap:RetainedEarningsMember2023-06-300001571934us-gaap:AdditionalPaidInCapitalMember2023-06-300001571934us-gaap:RetainedEarningsMember2022-12-310001571934us-gaap:AdditionalPaidInCapitalMember2022-12-310001571934us-gaap:RetainedEarningsMember2022-06-300001571934us-gaap:AdditionalPaidInCapitalMember2022-06-300001571934us-gaap:RetainedEarningsMember2022-03-310001571934us-gaap:AdditionalPaidInCapitalMember2022-03-3100015719342022-03-310001571934us-gaap:RetainedEarningsMember2021-12-310001571934us-gaap:AdditionalPaidInCapitalMember2021-12-310001571934us-gaap:PreferredStockMember2023-06-300001571934us-gaap:CommonStockMember2023-06-300001571934us-gaap:PreferredStockMember2022-12-310001571934us-gaap:CommonStockMember2022-12-310001571934us-gaap:PreferredStockMember2022-06-300001571934us-gaap:CommonStockMember2022-06-300001571934us-gaap:PreferredStockMember2022-03-310001571934us-gaap:CommonStockMember2022-03-310001571934us-gaap:PreferredStockMember2021-12-310001571934us-gaap:CommonStockMember2021-12-310001571934snpx:BoardMembersOfficersAndEmployeesMember2023-03-290001571934snpx:BoardMembersOfficersAndEmployeesMembersnpx:EquityIncentivePlan2020Member2022-11-150001571934snpx:EquityIncentivePlan2020Member2022-10-1100015719342022-10-110001571934us-gaap:RestrictedStockUnitsRSUMember2021-07-130001571934snpx:EquityIncentivePlan2020Member2021-04-0700015719342021-04-070001571934snpx:EquityIncentivePlan2020Member2020-12-070001571934snpx:ShareBasedPaymentArrangementNonemployeeDirectorsMembersnpx:DirectorCompensationPolicyMember2023-03-290001571934snpx:ShareBasedPaymentArrangementNewlyAppointedDirectorsMembersnpx:DirectorCompensationPolicyMember2023-03-290001571934srt:ChiefExecutiveOfficerMembersnpx:EquityIncentivePlan2020Member2022-02-162022-02-160001571934us-gaap:RestrictedStockUnitsRSUMemberus-gaap:ShareBasedPaymentArrangementEmployeeMember2021-07-132021-07-130001571934us-gaap:RestrictedStockUnitsRSUMembersrt:ChiefFinancialOfficerMember2021-07-132021-07-130001571934us-gaap:RestrictedStockUnitsRSUMembersnpx:ShareBasedPaymentArrangementNonemployeeDirectorsMember2021-07-132021-07-130001571934us-gaap:RestrictedStockMembersnpx:ConsultingAgreementWithSherwoodVenturesLlcMember2023-06-072023-06-070001571934us-gaap:RestrictedStockMembersnpx:ConsultingAgreementWithSherwoodVenturesLlcMember2023-03-222023-03-220001571934us-gaap:RestrictedStockMembersnpx:ConsultingAgreementWithSherwoodVenturesLlcMember2023-01-052023-01-050001571934us-gaap:RestrictedStockMembersnpx:ConsultingAgreementWithSherwoodVenturesLlcMember2022-12-072022-12-070001571934us-gaap:RestrictedStockMember2022-10-082022-10-080001571934us-gaap:RestrictedStockMember2022-09-082022-09-080001571934us-gaap:RestrictedStockMember2022-07-082022-07-080001571934us-gaap:RestrictedStockMember2022-06-072022-06-070001571934us-gaap:RestrictedStockMember2022-03-142022-03-140001571934us-gaap:RestrictedStockMember2022-02-152022-02-150001571934snpx:ShareBasedPaymentArrangementNewlyAppointedDirectorsMembersnpx:DirectorCompensationPolicyMemberus-gaap:ShareBasedCompensationAwardTrancheTwoMember2023-03-292023-03-290001571934snpx:ShareBasedPaymentArrangementNewlyAppointedDirectorsMembersnpx:DirectorCompensationPolicyMemberus-gaap:ShareBasedCompensationAwardTrancheOneMember2023-03-292023-03-290001571934snpx:ShareBasedPaymentArrangementNewlyAppointedDirectorsMembersnpx:DirectorCompensationPolicyMember2023-03-292023-03-290001571934us-gaap:RestrictedStockUnitsRSUMemberus-gaap:ShareBasedCompensationAwardTrancheTwoMember2022-12-312022-12-310001571934us-gaap:RestrictedStockUnitsRSUMemberus-gaap:ShareBasedCompensationAwardTrancheOneMember2022-09-152022-09-150001571934us-gaap:StockOptionMember2023-01-012023-06-300001571934snpx:ServicesAgreement2022Member2023-04-012023-06-300001571934snpx:ServicesAgreement2020Member2023-04-012023-06-300001571934snpx:NationalInstitutesOfHealthMembersnpx:ServicesAgreement2022Member2023-01-012023-06-300001571934snpx:ServicesAgreement2022Member2023-01-012023-06-300001571934snpx:ServicesAgreement2020Member2023-01-012023-06-300001571934snpx:ServicesAgreement2020Member2022-04-012022-06-300001571934snpx:ServicesAgreement2022Member2022-01-012022-12-310001571934snpx:ServicesAgreement2020Member2022-01-012022-06-300001571934srt:MinimumMember2023-06-300001571934srt:MaximumMember2023-06-300001571934us-gaap:WarrantMember2022-01-012022-06-300001571934us-gaap:SeriesBPreferredStockMembersnpx:November2022PrivatePlacementMember2022-01-012022-12-310001571934srt:MaximumMembersnpx:AgreementsWithBryologyxMember2020-06-092020-06-090001571934snpx:AgreementsWithBryologyxMember2023-01-012023-06-300001571934us-gaap:FairValueInputsLevel3Memberus-gaap:WarrantMemberus-gaap:FairValueMeasurementsRecurringMember2023-06-300001571934us-gaap:FairValueInputsLevel3Memberus-gaap:EmbeddedDerivativeFinancialInstrumentsMemberus-gaap:FairValueMeasurementsRecurringMember2023-06-300001571934us-gaap:FairValueInputsLevel3Memberus-gaap:WarrantMemberus-gaap:FairValueMeasurementsRecurringMember2022-12-310001571934us-gaap:FairValueInputsLevel3Memberus-gaap:EmbeddedDerivativeFinancialInstrumentsMemberus-gaap:FairValueMeasurementsRecurringMember2022-12-310001571934snpx:NationalInstitutesOfHealthMembersnpx:ServicesAgreement2020Member2021-04-300001571934us-gaap:WarrantMember2023-06-300001571934us-gaap:EmbeddedDerivativeFinancialInstrumentsMember2023-06-300001571934us-gaap:WarrantMember2022-12-310001571934us-gaap:EmbeddedDerivativeFinancialInstrumentsMember2022-12-310001571934us-gaap:WarrantMember2023-01-012023-06-300001571934us-gaap:EmbeddedDerivativeFinancialInstrumentsMember2023-01-012023-06-300001571934us-gaap:WarrantMember2022-01-012022-12-310001571934us-gaap:EmbeddedDerivativeFinancialInstrumentsMember2022-01-012022-12-310001571934snpx:November2022PrivatePlacementMember2023-04-012023-06-300001571934snpx:AdvisoryAgreementsMember2023-04-012023-06-300001571934snpx:AdvisoryAgreementsMember2023-01-012023-06-300001571934snpx:AdvisoryAgreementsMember2022-11-012022-11-300001571934snpx:November2022PrivatePlacementMember2022-04-012022-06-300001571934snpx:November2022PrivatePlacementMember2022-01-012022-06-300001571934us-gaap:RestrictedStockUnitsRSUMember2023-06-300001571934us-gaap:RestrictedStockUnitsRSUMember2022-12-310001571934us-gaap:MeasurementInputRiskFreeInterestRateMembersnpx:November2022PrivatePlacementMember2023-06-300001571934us-gaap:MeasurementInputExpectedTermMembersnpx:November2022PrivatePlacementMember2023-06-300001571934us-gaap:MeasurementInputExpectedDividendRateMembersnpx:November2022PrivatePlacementMember2023-06-300001571934us-gaap:MeasurementInputDefaultRateMembersnpx:November2022PrivatePlacementMember2023-06-300001571934snpx:MeasurementInputPenaltyDividendRateMembersnpx:November2022PrivatePlacementMember2023-06-300001571934snpx:MeasurementInputEstimatedTradedVolatilityMembersnpx:November2022PrivatePlacementMember2023-06-300001571934snpx:MeasurementInputEstimatedEquityVolatilityMembersnpx:November2022PrivatePlacementMember2023-06-300001571934us-gaap:MeasurementInputSharePriceMemberus-gaap:SeriesBPreferredStockMembersnpx:November2022PrivatePlacementMember2022-11-170001571934us-gaap:MeasurementInputRiskFreeInterestRateMemberus-gaap:SeriesBPreferredStockMembersnpx:November2022PrivatePlacementMember2022-11-170001571934us-gaap:MeasurementInputExpectedTermMemberus-gaap:SeriesBPreferredStockMembersnpx:November2022PrivatePlacementMember2022-11-170001571934us-gaap:MeasurementInputExpectedDividendRateMemberus-gaap:SeriesBPreferredStockMembersnpx:November2022PrivatePlacementMember2022-11-170001571934us-gaap:MeasurementInputDefaultRateMemberus-gaap:SeriesBPreferredStockMembersnpx:November2022PrivatePlacementMember2022-11-170001571934snpx:MeasurementInputPenaltyDividendRateMemberus-gaap:SeriesBPreferredStockMembersnpx:November2022PrivatePlacementMember2022-11-170001571934snpx:MeasurementInputEstimatedTradedVolatilityMemberus-gaap:SeriesBPreferredStockMembersnpx:November2022PrivatePlacementMember2022-11-170001571934snpx:MeasurementInputEstimatedEquityVolatilityMemberus-gaap:SeriesBPreferredStockMembersnpx:November2022PrivatePlacementMember2022-11-170001571934snpx:November2022PrivatePlacementMember2023-06-300001571934us-gaap:SeriesBPreferredStockMembersnpx:November2022PrivatePlacementMember2022-12-310001571934us-gaap:SeriesBPreferredStockMemberus-gaap:PreferredStockMembersnpx:November2022PrivatePlacementMember2022-11-170001571934snpx:AdvisoryAgreementsMember2022-11-220001571934snpx:PlacementAgentsMembersnpx:November2022PrivatePlacementMember2022-11-170001571934us-gaap:RestrictedStockMember2022-07-080001571934snpx:SeriesGWarrantsMember2022-06-300001571934snpx:SeriesEWarrantsMember2022-06-300001571934snpx:ConsultingAgreementWithKatalystSecuritiesLlcMember2022-01-030001571934snpx:ConsultingAgreementWithGpNurmenkariIncMember2022-01-030001571934snpx:AdvisoryAgreementsMember2022-01-030001571934snpx:ConsultingAgreementWithKatalystSecuritiesLlcMember2021-10-010001571934snpx:ConsultingAgreementWithGpNurmenkariIncMember2021-10-010001571934snpx:ConsultingAgreementWithKatalystSecuritiesLlcMember2021-07-010001571934snpx:ConsultingAgreementWithGpNurmenkariIncMember2021-07-010001571934snpx:ConsultingAgreementWithKatalystSecuritiesLlcMember2021-04-010001571934snpx:ConsultingAgreementWithGpNurmenkariIncMember2021-04-010001571934snpx:ConsultingAgreementWithKatalystSecuritiesLlcMember2021-02-160001571934snpx:ConsultingAgreementWithGpNurmenkariIncMember2021-02-1600015719342022-06-3000015719342021-12-310001571934us-gaap:WarrantMember2023-04-012023-06-300001571934us-gaap:EmployeeStockOptionMember2023-04-012023-06-300001571934us-gaap:ConvertiblePreferredStockMember2023-04-012023-06-300001571934us-gaap:WarrantMember2023-01-012023-06-300001571934us-gaap:EmployeeStockOptionMember2023-01-012023-06-300001571934us-gaap:ConvertiblePreferredStockMember2023-01-012023-06-300001571934us-gaap:WarrantMember2022-04-012022-06-300001571934us-gaap:RestrictedStockUnitsRSUMember2022-04-012022-06-300001571934us-gaap:EmployeeStockOptionMember2022-04-012022-06-300001571934us-gaap:WarrantMember2022-01-012022-06-300001571934us-gaap:RestrictedStockUnitsRSUMember2022-01-012022-06-300001571934us-gaap:EmployeeStockOptionMember2022-01-012022-06-300001571934us-gaap:ResearchAndDevelopmentExpenseMembersnpx:EquityIncentivePlan2020Member2023-04-012023-06-300001571934us-gaap:GeneralAndAdministrativeExpenseMembersnpx:EquityIncentivePlan2020Member2023-04-012023-06-300001571934snpx:EquityIncentivePlan2020Member2023-04-012023-06-300001571934us-gaap:ResearchAndDevelopmentExpenseMembersnpx:EquityIncentivePlan2020Member2023-01-012023-06-300001571934us-gaap:GeneralAndAdministrativeExpenseMembersnpx:EquityIncentivePlan2020Member2023-01-012023-06-300001571934us-gaap:RestrictedStockUnitsRSUMember2023-01-012023-06-300001571934snpx:EquityIncentivePlan2020Member2023-01-012023-06-300001571934us-gaap:ResearchAndDevelopmentExpenseMembersnpx:EquityIncentivePlan2020Member2022-04-012022-06-300001571934us-gaap:GeneralAndAdministrativeExpenseMembersnpx:EquityIncentivePlan2020Member2022-04-012022-06-300001571934us-gaap:RestrictedStockUnitsRSUMember2022-04-012022-06-300001571934snpx:EquityIncentivePlan2020Member2022-04-012022-06-300001571934us-gaap:ResearchAndDevelopmentExpenseMembersnpx:EquityIncentivePlan2020Member2022-01-012022-06-300001571934us-gaap:GeneralAndAdministrativeExpenseMembersnpx:EquityIncentivePlan2020Member2022-01-012022-06-300001571934us-gaap:RestrictedStockUnitsRSUMember2022-01-012022-06-300001571934snpx:EquityIncentivePlan2020Member2022-01-012022-06-300001571934us-gaap:CommonStockMember2023-04-012023-06-300001571934us-gaap:CommonStockMember2023-01-012023-06-300001571934us-gaap:RetainedEarningsMember2022-04-012022-06-300001571934us-gaap:PreferredStockMember2022-04-012022-06-300001571934us-gaap:CommonStockMember2022-04-012022-06-300001571934us-gaap:AdditionalPaidInCapitalMember2022-04-012022-06-300001571934us-gaap:RetainedEarningsMember2022-01-012022-06-300001571934us-gaap:CommonStockMember2022-01-012022-06-300001571934us-gaap:SeriesBPreferredStockMember2022-01-012022-12-310001571934snpx:EquityIncentivePlan2020Member2023-06-300001571934us-gaap:RestrictedStockMember2022-10-080001571934us-gaap:RestrictedStockMember2022-02-1500015719342023-06-302023-06-300001571934snpx:November2022PrivatePlacementMember2023-01-012023-06-300001571934us-gaap:RestrictedStockMembersnpx:ConsultingAgreementWithSherwoodVenturesLlcMember2022-11-3000015719342023-07-130001571934srt:MinimumMembersnpx:November2022PrivatePlacementMember2022-11-172022-11-170001571934srt:MaximumMembersnpx:November2022PrivatePlacementMember2022-11-172022-11-170001571934snpx:November2022PrivatePlacementMember2022-11-170001571934snpx:November2022PrivatePlacementMember2022-11-172022-11-170001571934snpx:ServicesAgreement2022Member2022-05-122022-05-120001571934us-gaap:AdditionalPaidInCapitalMember2022-01-012022-06-3000015719342023-08-010001571934us-gaap:PreferredStockMember2022-01-012022-06-300001571934us-gaap:RestrictedStockUnitsRSUMember2022-01-012022-12-310001571934srt:MinimumMembersnpx:Mt.SinaiLicenseAgreementMember2017-01-192017-01-190001571934srt:MaximumMembersnpx:StanfordLicenseAgreementsMember2017-01-192017-01-190001571934snpx:NetSalesUpToDollars250MillionMembersnpx:Mt.SinaiLicenseAgreementMember2014-07-142014-07-140001571934snpx:NetSalesOverDollarsMillionMembersnpx:Mt.SinaiLicenseAgreementMember2014-07-142014-07-140001571934snpx:StanfordLicenseAgreementsMember2014-05-122014-05-120001571934snpx:NationalInstitutesOfHealthMembersnpx:ServicesAgreement2020Member2020-04-012020-04-300001571934srt:MinimumMemberus-gaap:SeriesBPreferredStockMembersnpx:November2022PrivatePlacementMember2023-04-142023-04-140001571934snpx:PlacementAgentsMembersnpx:November2022PrivatePlacementMember2022-11-172022-11-170001571934snpx:AgreementsWithBryologyxMember2020-06-090001571934us-gaap:SeriesBPreferredStockMembersnpx:November2022PrivatePlacementMember2022-11-172022-11-170001571934srt:MaximumMemberus-gaap:SeriesBPreferredStockMembersnpx:November2022PrivatePlacementMember2023-05-112023-05-110001571934us-gaap:SeriesBPreferredStockMembersnpx:November2022PrivatePlacementMember2023-05-112023-05-110001571934srt:MaximumMemberus-gaap:SeriesBPreferredStockMembersnpx:November2022PrivatePlacementMember2023-04-142023-04-140001571934us-gaap:SeriesBPreferredStockMember2023-04-142023-04-1400015719342023-06-0100015719342022-04-012022-06-300001571934snpx:SeriesGWarrantsMember2022-01-012022-06-300001571934snpx:SeriesEWarrantsMember2022-01-012022-06-3000015719342022-01-012022-12-3100015719342021-01-012021-12-310001571934us-gaap:RestrictedStockUnitsRSUMemberus-gaap:ShareBasedPaymentArrangementEmployeeMember2021-07-130001571934us-gaap:RestrictedStockUnitsRSUMember2022-11-302022-11-300001571934us-gaap:RestrictedStockUnitsRSUMember2021-07-132021-07-130001571934snpx:BoardMembersOfficersAndEmployeesMember2023-03-292023-03-290001571934snpx:BoardMembersOfficersAndEmployeesMembersnpx:EquityIncentivePlan2020Member2022-11-152022-11-1500015719342023-04-240001571934snpx:Mt.SinaiLicenseAgreementMember2023-01-012023-06-300001571934srt:MaximumMembersnpx:StanfordLicenseAgreementsMember2014-05-122014-05-120001571934snpx:Mt.SinaiLicenseAgreementMember2014-07-142014-07-140001571934us-gaap:SeriesBPreferredStockMembersnpx:November2022PrivatePlacementMember2023-04-142023-04-1400015719342022-01-012022-06-300001571934snpx:NationalInstitutesOfHealthMembersnpx:ServicesAgreement2020Member2020-07-230001571934snpx:ServicesAgreement2020Member2020-07-2300015719342023-07-310001571934us-gaap:RetainedEarningsMember2023-04-012023-06-300001571934us-gaap:PreferredStockMember2023-04-012023-06-300001571934us-gaap:AdditionalPaidInCapitalMember2023-04-012023-06-300001571934us-gaap:RetainedEarningsMember2023-01-012023-06-300001571934us-gaap:PreferredStockMember2023-01-012023-06-300001571934us-gaap:AdditionalPaidInCapitalMember2023-01-012023-06-3000015719342023-04-012023-06-300001571934snpx:ConsultingAgreementWithKatalystSecuritiesLlcMember2022-01-012022-01-010001571934snpx:ConsultingAgreementWithGpNurmenkariIncMember2022-01-012022-01-010001571934snpx:ConsultingAgreementWithGpNurmenkariIncMember2021-07-012021-07-010001571934snpx:ConsultingAgreementWithKatalystSecuritiesLlcMember2021-01-012021-01-010001571934snpx:ConsultingAgreementWithGpNurmenkariIncMember2021-01-012021-01-010001571934snpx:ConsultingAgreementWithSmCapitalManagementLlcMember2023-04-012023-06-300001571934snpx:ConsultingAgreementWithKatalystSecuritiesLlcMember2023-04-012023-06-300001571934snpx:ConsultingAgreementWithGpNurmenkariIncMember2023-04-012023-06-300001571934snpx:ConsultingAgreementWithSmCapitalManagementLlcMember2023-01-012023-06-300001571934snpx:ConsultingAgreementWithKatalystSecuritiesLlcMember2023-01-012023-06-300001571934snpx:ConsultingAgreementWithGpNurmenkariIncMember2023-01-012023-06-300001571934snpx:ConsultingAgreementWithSmCapitalManagementLlcMember2022-04-012022-06-300001571934snpx:ConsultingAgreementWithKatalystSecuritiesLlcMember2022-04-012022-06-300001571934snpx:ConsultingAgreementWithGpNurmenkariIncMember2022-04-012022-06-300001571934snpx:ConsultingAgreementWithSmCapitalManagementLlcMember2022-01-012022-06-300001571934snpx:ConsultingAgreementWithKatalystSecuritiesLlcMember2022-01-012022-06-300001571934snpx:ConsultingAgreementWithGpNurmenkariIncMember2022-01-012022-06-300001571934snpx:StanfordLicenseAgreementsMember2017-01-192017-01-190001571934snpx:ClevelandClinicAgreementMember2023-02-232023-02-230001571934snpx:StanfordLicenseAgreementsMember2023-01-012023-06-300001571934snpx:NemoursAgreementMember2021-05-082021-05-080001571934snpx:NemoursAgreementMember2023-01-012023-06-300001571934snpx:ServicesAgreement2020Member2022-02-102022-02-1000015719342023-06-3000015719342022-12-310001571934us-gaap:LicenseMembersnpx:StanfordLicenseAgreementsMember2017-01-192017-01-190001571934snpx:EmploymentAgreementWithAlanJ.TuchmanM.dMember2020-12-070001571934snpx:ConsultingAgreementWithSmCapitalManagementLlcMember2016-08-042016-08-040001571934snpx:NationalInstitutesOfHealthMembersnpx:ServicesAgreement2020Member2023-01-012023-06-300001571934snpx:NationalInstitutesOfHealthMembersnpx:ServicesAgreement2020Member2020-07-232020-07-230001571934snpx:ServicesAgreement2020Member2022-02-100001571934snpx:ServicesAgreement2020Member2022-01-220001571934snpx:EmploymentAgreementWithAlanJ.TuchmanM.dMember2020-12-072020-12-070001571934snpx:Mt.SinaiLicenseAgreementMember2014-07-140001571934snpx:EmploymentAgreementWithAlanJ.TuchmanM.dMember2022-08-042022-08-040001571934snpx:ServicesAgreement2022Member2023-06-300001571934snpx:ServicesAgreement2020Member2023-06-3000015719342023-08-1000015719342023-01-012023-06-30snpx:Votesnpx:installmentsnpx:Yxbrli:sharesiso4217:USDxbrli:pureiso4217:USDxbrli:sharessnpx:itemsnpx:Dsnpx:directorsnpx:employeesnpx:agreement

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2023

or

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from __________________ to __________________

Commission File Number: 001-40458

SYNAPTOGENIX, INC.

(Exact name of registrant as specified in its charter)

Delaware

46-1585656

(State or other jurisdiction of incorporation or

(I.R.S. Employer

organization)

Identification No.)

1185 Avenue of the Americas, 3rd Floor

New York, New York

10036

(Address of principal executive offices)

(Zip code)

(973) 242-0005

(Registrant’s telephone number, including area code)

(Former name, former address and former fiscal year, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

    

Trading Symbol(s)

    

Name of each exchange on
which registered

Common Stock, $0.0001 par value per share

    

SNPX

    

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes   No 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes   No 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act) Yes  No 

As of August 10, 2023, there were 10,164,529 shares of the registrant’s common stock, $0.0001 par value per share, issued and outstanding.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION

Certain statements in this report contain or may contain forward-looking statements. These statements, identified by words such as “plan,” “anticipate,” “believe,” “estimate,” “should,” “expect” and similar expressions, include our expectations and objectives regarding our future financial position, operating results and business strategy. These statements are subject to known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. These forward-looking statements were based on various factors and were derived utilizing numerous assumptions and other factors that could cause our actual results to differ materially from those in the forward-looking statements. These factors include, but are not limited to, the significant length of time associated with drug development and related insufficient cash flows and resulting illiquidity, our patent portfolio, our inability to expand our business, significant government regulation of pharmaceuticals and the healthcare industry, lack of product diversification, availability of our raw materials, existing or increased competition, stock volatility and illiquidity, and our failure to implement our business plans or strategies. Most of these factors are difficult to predict accurately and are generally beyond our control. You should consider the areas of risk described in connection with any forward-looking statements that may be made herein. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this report. You should carefully review this report in its entirety, including but not limited to our financial statements and the notes thereto and the risks described in Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the Securities and Exchange Commission (the “SEC”) on March 21, 2023. We advise you to carefully review the reports and documents we file from time to time with the SEC including our current reports on Form 8-K. Except for our ongoing obligations to disclose material information under securities laws, we undertake no obligation to publicly release any revisions to any forward-looking statements, to report events or to report the occurrence of unanticipated events.

1

TABLE OF CONTENTS

Page

Part I – FINANCIAL INFORMATION

3

 

Item 1. Financial Statements (Unaudited)

3

 

Condensed Balance Sheets as of June 30, 2023 and December 31, 2022

3

 

Condensed Statements of Operations for the three and six months ended June 30, 2023 and 2022

4

 

Condensed Statements of Changes in Stockholders’ Equity for the three and six months ended June 30, 2023 and 2022

5

 

Condensed Statements of Cash Flows for the six months ended June 30, 2023 and 2022

7

 

Notes to Condensed Financial Statements

8

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

27

 

Item 3. Quantitative and Qualitative Disclosures about Market Risk

34

 

Item 4. Controls and Procedures

35

 

Part II – OTHER INFORMATION

36

 

Item 1. Legal Proceedings

36

 

Item 1A. Risk Factors

36

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

36

 

Item 3. Defaults upon Senior Securities

36

 

Item 4. Mine Safety Disclosures

36

 

Item 5. Other Information

36

 

Item 6. Exhibits

37

 

Signatures

38

2

PART I

FINANCIAL INFORMATION

Item 1. Financial Statements.

Synaptogenix, Inc.

Condensed Balance Sheets

(Unaudited)

June 30, 

December 31, 

    

2023

    

2022

ASSETS

CURRENT ASSETS

Cash and cash equivalents

$

32,899,410

$

37,478,480

Prepaid Clinical trial expenses

 

130,548

367,714

Prepaid expenses and other current assets

 

385,769

739,467

TOTAL CURRENT ASSETS

 

33,415,727

 

38,585,661

 

 

Fixed assets, net of accumulated depreciation

 

21,438

 

22,145

 

 

TOTAL ASSETS

$

33,437,165

$

38,607,806

 

  

 

  

 

  

 

  

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

  

 

  

 

  

 

  

CURRENT LIABILITIES

 

  

 

  

Accounts payable

$

439,147

$

660,206

Accrued expenses

 

68,137

 

536,714

Dividend payable

115,890

Accrued Series B Convertible Preferred payments payable

2,265,375

 

 

TOTAL CURRENT LIABILITIES

 

2,772,659

 

1,312,810

Warrant liability

1,129,000

1,510,000

Derivative liability

2,628,000

370,300

TOTAL LIABILITIES

6,529,659

3,193,110

 

  

 

  

Commitments and contingencies

 

  

 

  

 

  

 

  

Series B Convertible redeemable preferred stock, $.0001 par value and $1,000 face value, 1,000,000 shares authorized; 14,000 and 15,000 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively. Liquidation preference of $14,000,000 plus dividends accrued at 7% per annum of $165,375 as of June 30, 2023.

2,077,379

2,721,723

STOCKHOLDERS' EQUITY

Common stock - 150,000,000 shares authorized, $0.0001 par value; 7,365,280 shares issued and outstanding as of June 30, 2023 and 7,267,032 shares issued and outstanding as of December 31, 2022.

738

728

Additional paid-in capital

56,849,293

52,523,762

Accumulated deficit

(32,019,904)

(19,831,517)

TOTAL STOCKHOLDERS’ EQUITY

 

24,830,127

 

32,692,973

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

$

33,437,165

$

38,607,806

See accompanying notes to condensed financial statements.

3

Synaptogenix, Inc.

Condensed Statements of Operations

(Unaudited)

    

Three Months Ended

    

Three Months Ended

    

Six Months Ended

    

Six Months Ended

June 30, 

June 30, 

June 30, 

June 30, 

2023

2022

2023

2022

OPERATING EXPENSES:

Research and development

 

$

307,211

$

1,941,101

$

1,184,928

$

3,427,175

General and administrative

 

1,522,502

 

1,855,290

 

3,566,726

 

3,651,748

 

  

 

 

  

 

TOTAL OPERATING EXPENSES

 

1,829,713

 

3,796,391

 

4,751,654

 

7,078,923

 

  

 

 

  

 

OTHER INCOME (EXPENSE):

 

Interest income

 

427,159

 

44,487

 

823,516

 

49,097

Change in fair value of warrant liability

(207,000)

381,000

Change in fair value of derivative liability

(2,484,400)

(2,258,600)

TOTAL OTHER INCOME (EXPENSE)

 

(2,264,241)

 

44,487

 

(1,054,084)

 

49,097

Net loss before income taxes

 

4,093,954

 

3,751,904

 

5,805,738

 

7,029,826

 

 

 

  

 

Provision for income taxes

 

 

 

 

Net loss

4,093,954

3,751,904

5,805,738

7,029,826

Preferred Stock dividends

423,575

689,649

Deemed dividend - preferred stock extinguishment

5,693,000

5,693,000

 

 

 

  

 

Net loss attributable to common stockholders

$

10,210,529

$

3,751,904

$

12,188,387

$

7,029,826

 

 

 

 

PER SHARE DATA:

 

 

 

 

 

 

 

 

Basic and diluted loss per common share

$

1.39

$

0.54

$

1.66

$

1.01

 

 

 

 

Basic and diluted weighted average common shares outstanding

 

7,361,300

 

6,959,400

 

7,356,600

 

6,949,400

See accompanying notes to condensed financial statements.

4

Synaptogenix, Inc.

Condensed Statements of Changes in Stockholders’ Equity

 

(Unaudited)

    

Three Months Ended June 30, 2022

Additional

Preferred Stock

Common Stock

Paid-In

Accumulated

    

Shares

    

Amount

  

  

Shares

    

Amount

    

Capital

    

Deficit

    

Total

 

  

 

  

 

  

 

  

 

  

 

  

 

  

Balance April 1, 2022

 

$

6,809,647

$

682

$

49,102,898

$

(17,419,592)

$

31,683,988

 

  

 

  

  

 

  

 

  

 

  

 

Stock based compensation

 

 

 

 

1,016,690

 

 

1,016,690

 

  

 

  

  

 

  

 

  

 

  

 

Issuance of warrants for consulting fees

 

 

 

 

 

 

 

  

 

  

  

 

  

 

  

 

 

Issuance of common stock for consulting fees

679

4,499

4,499

Exercise of common stock warrants

Net loss

 

 

 

 

 

(3,751,904)

 

(3,751,904)

 

  

 

  

  

 

  

 

  

 

  

 

Balance June 30, 2022

 

$

$

6,810,326

$

682

$

50,124,087

$

(21,171,496)

$

28,953,273

    

Three Months Ended June 30, 2023

Additional

Preferred Stock

Common Stock

Paid-In

Accumulated

   

Shares

   

Amount

  

  

Shares

   

Amount

   

Capital

   

Deficit

   

Total

Balance April 1, 2023

 

15,000

$

2,721,723

7,359,871

$

737

$

53,273,034

$

(21,809,375)

$

31,464,396

Stock based compensation

 

 

 

 

334,416

 

 

334,416

Issuance of common stock for consulting fees

 

 

5,409

 

1

 

4,499

 

 

4,500

Accrued preferred stock dividends

(423,575)

(423,575)

Preferred stock dividends paid

(423,575)

Reclassification of accrued dividends upon probable redemption of preferred stock

165,375

Deemed dividend - preferred stock extinguishment

423,575

5,693,000

(5,693,000)

Preferred stock redemptions

(1,000)

(1,000,000)

Accrual of preferred stock and dividend redemption

(2,265,375)

Preferred stock accretion

2,455,656

(2,455,656)

(2,455,656)

Net loss

 

 

 

 

 

(4,093,954)

 

(4,093,954)

Balance June 30, 2023

14,000

$

2,077,379

7,365,280

$

738

$

56,849,293

$

(32,019,904)

$

24,830,127

5

    

Six Months Ended June 30, 2022

Additional

Preferred Stock

Common Stock

Paid-In

Accumulated

    

Shares

    

Amount

    

Shares

    

Amount

    

Capital

    

Deficit

    

Total

Balance January 1, 2022

 

$

 

6,730,180

$

674

$

47,670,744

$

(14,141,670)

$

33,529,748

Stock based compensation

 

 

 

 

 

1,728,248

 

 

1,728,248

Issuance of warrants for consulting fees

 

 

 

 

 

71,603

 

 

71,603

Issuance of common stock for consulting fees

 

 

 

15,146

 

1

 

100,349

 

 

100,350

Exercise of common stock warrants

 

 

 

65,000

 

7

 

553,143

 

 

553,150

Net loss

 

 

 

 

 

 

(7,029,826)

 

(7,029,826)

Balance June 30, 2022

$

$

6,810,326

$

682

$

50,124,087

$

(21,171,496)

$

28,953,273

    

Six Months Ended June 30, 2023

Additional

Preferred Stock

Common Stock

Paid-In

Accumulated

    

Shares

    

Amount

    

Shares

    

Amount

    

Capital

    

Deficit

    

Total

 

  

 

  

 

  

 

  

 

  

 

  

 

  

Balance January 1, 2023

 

15,000

$

2,721,723

 

7,267,032

$

728

$

52,523,762

$

(19,831,517)

$

32,692,973

Stock based compensation

 

 

 

 

 

979,197

 

 

979,197

Issuance of common stock for consulting fees

98,248

10

108,990

109,000

Accrued preferred stock dividends

(689,649)

(689,649)

Preferred stock dividends paid

(689,649)

Reclassification of accrued dividends upon probable redemption of preferred stock

165,375

Deemed dividend - preferred stock extinguishment

689,649

5,693,000

(5,693,000)

Preferred stock redemptions

(1,000)

(1,000,000)

Accrual of preferred stock and dividend redemption

(2,265,375)

Preferred stock accretion

2,455,656

(2,455,656)

(2,455,656)

Net loss

 

 

 

 

 

 

(5,805,738)

 

(5,805,738)

Balance June 30, 2023

 

14,000

$

2,077,379

 

7,365,280

$

738

$

56,849,293

$

(32,019,904)

$

24,830,127

See accompanying notes to condensed financial statements.

6

Synaptogenix, Inc.

Condensed Statements of Cash Flows

(Unaudited)

    

Six Months Ended

    

Six Months Ended

June 30, 2023

June 30, 2022

CASH FLOW USED IN OPERATING ACTIVITIES

Net loss

$

(5,805,738)

$

(7,029,826)

Adjustments to reconcile net loss to net cash used by operating activities

Stock based compensation

979,197

1,728,248

Change in fair value of warrant liability

(381,000)

Change in fair value of derivative liability

2,258,600

Consulting services paid by issuance of common stock

 

109,000

 

100,349

Consulting services paid by issuance of common stock warrants

71,603

Depreciation expense

 

3,414

 

2,697

Change in assets and liabilities:

Decrease in prepaid expenses

 

590,864

 

486,372

Decrease in accounts payable

 

(221,059)

 

(1,015,640)

Decrease in accrued expenses

 

(468,577)

 

(353,292)

Total adjustments

 

2,870,439

 

1,020,337

 

 

Net Cash Used in Operating Activities

 

(2,935,299)

 

(6,009,489)

CASH FLOWS USED IN INVESTING ACTIVITIES

Purchase of fixed assets

(2,707)

(3,029)

Net Cash Used in Investing Activities

(2,707)

(3,029)

 

 

CASH FLOWS FROM FINANCING ACTIVITIES

 

 

Proceeds from exercise of investor warrants

553,150

Redemption of Series B Convertible Preferred Stock

(1,000,000)

Dividends on Series B Convertible Preferred Stock

(641,064)

Net Cash Provided by Financing Activities

 

(1,641,064)

 

553,150

 

 

NET DECREASE IN CASH AND EQUIVALENTS

 

(4,579,070)

 

(5,459,368)

 

 

CASH AND EQUIVALENTS AT BEGINNING OF PERIOD

 

37,478,480

 

34,213,989

 

 

CASH AND EQUIVALENTS AT END OF PERIOD

$

32,899,410

$

28,754,621

DISCLOSURES OF NON-CASH FINANCING ACTIVITIES:

Accrual of Series B Convertible Preferred Stock Dividends

$

689,649

$

115,890

Accretion of Series B Convertible Preferred Stock to redemption value

$

2,455,656

$

Deemed dividend for Series B Convertible Preferred Stock modification

$

5,693,000

$

Accrual of Series B Convertible Preferred Stock and Dividend Redemption

$

2,265,375

$

See accompanying notes to condensed financial statements.

7

SYNAPTOGENIX, INC.

NOTES TO FINANCIAL STATEMENTS

(UNAUDITED)

Unless the context otherwise indicates, references in these Notes to the accompanying financial statements to “we,” “us,” “our” and “the Company” refer to Synaptogenix, Inc. (formerly known as Neurotrope Bioscience, Inc.), a Delaware corporation. References to “Neurotrope”, “Parent Company” or “Parent” refer to Neurotrope, Inc., a Nevada corporation.

Note 1 – Organization, Business, Risks and Uncertainties:

Organization and Business

On May 17, 2020, Neurotrope, Inc. (“Neurotrope” or “the Parent”) announced plans for the complete legal and structural separation of its wholly owned subsidiary, Neurotrope Bioscience, Inc., from Neurotrope (the “Spin-Off”). Under the Separation and Distribution Agreement, Neurotrope planned to distribute all of its equity interest in this wholly owned subsidiary to Neurotrope’s stockholders. Following the Spin-Off, Neurotrope does not own any equity interest in the Company, and the Company operates independently from Neurotrope. On December 7, 2020, the Company became an independent company, Synaptogenix, Inc., a Delaware corporation (formerly known as Neurotrope Bioscience, Inc.) (the “Company” or “Synaptogenix”) when the Company filed an amended and restated certificate of incorporation which, among other things, changed its name to Synaptogenix, Inc. The Company’s shares of common stock, par value $0.0001 per share (the “Common Stock”), are listed on The Nasdaq Capital Market under the symbol “SNPX.”

Neurotrope Bioscience, Inc. was incorporated in Delaware on October 31, 2012 to advance new therapeutic and diagnostic technologies in the field of neurodegenerative disease, primarily Alzheimer’s disease (“AD”). The Company is collaborating with Cognitive Research Enterprises, Inc. (formerly known as the Blanchette Rockefeller Neurosciences Institute, or BRNI) (“CRE”), a related party, in this process. The exclusive rights to certain technology were licensed by CRE to the Company on February 28, 2013 (see Note 4 - Related Party Transactions).

In connection with the separation from Neurotrope, the Company entered into a Separation and Distribution Agreement and several other ancillary agreements. These agreements govern the relationship between the parties after the separation and allocate between the parties’ various assets, liabilities, rights and obligations following the separation, including employee benefits, intellectual property, information technology, insurance and tax-related liabilities.

On December 16, 2022, the Company issued a press release announcing that an extended confirmatory Phase 2 study of Bryostatin-1 in moderate to severe AD (Study #204) did not achieve statistical significance on the primary endpoint, which was changed from baseline to Week 13 in the Severe Impairment Battery (“SIB”) total score assessment obtained after completion of the second seven-dose course of treatment (week 28 of trial). On March 7, 2023, the Company announced results of its analysis of secondary endpoints and post hoc analysis from our Phase 2 study of Bryostatin-1. In the secondary endpoint analysis, changes from baseline at Weeks 9, 20, 24, 30, and 42 in the SIB (Severe Impairment Battery) total score were not statistically significant in the total patient population, and no pre-specified secondary endpoints were met with statistical significance in the low-to-moderately severe AD patient stratum. However, nearly all pre-specified secondary endpoints in the most advanced and severe AD (Mini Mental State Exam 2 (“MMSE”) (baseline scores: 10-14) patient population, with baseline MMSE-2 (Mini-Mental State Examination, 2nd Edition) scores of 10-14, were achieved with statistical significance (p = <0.05, 2-tailed). Data also showed statistical significance in exploratory secondary endpoints for the MMSE-2 10-14 stratum, and post hoc analysis was positive.

On April 24, 2023, the Company received a written notice from the Listing Qualifications Department of the Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that for the preceding 30 consecutive business days, the Company’s common stock did not maintain a minimum closing bid price of $1.00 per share as required by Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has a grace period of 180 calendar days, or until October 23, 2023, to regain compliance with Nasdaq Listing Rule 5550(a)(2). Compliance can be achieved automatically and without further action if the closing bid price of the Company’s stock is at or above $1.00 for a minimum of 10 consecutive business days at any time during the 180-day compliance period, in which case Nasdaq will notify the Company of its compliance and the matter will be closed. If, however, the Company does not achieve compliance with the Minimum Bid Price Requirement by October 23, 2023, the Company may be eligible for additional time to comply.

8

Liquidity Uncertainties

As of June 30, 2023, the Company had approximately $32.9 million in cash and cash equivalents as compared to $37.5 million at December 31, 2022. The Company expects that its current cash and cash equivalents, approximately $32.5 million as of the date of this Quarterly Report on Form 10-Q, will be sufficient to support its projected operating requirements and financial commitments for at least the next 12 months from this date. The operating requirements include the current development plans for Bryostatin-1, our novel drug candidate targeting the activation of Protein Kinase C Epsilon and other development projects. The financial commitments include the potential redemption of the Series B Convertible Preferred Stock for cash.

The Company expects to need additional capital in order to initiate and pursue potential additional development projects, including the continuing development beyond the ongoing Phase 2 trial of Bryostatin-1. Any additional equity financing, if available, may not be on favorable terms and would likely be significantly dilutive to the Company’s current stockholders, and debt financing, if available, may involve restrictive covenants. If the Company is able to access funds through collaborative or licensing arrangements, it may be required to relinquish rights to some of its technologies or product candidates that the Company would otherwise seek to develop or commercialize on its own, on terms that are not favorable to the Company. The Company’s ability to access capital when needed is not assured and, if not achieved on a timely basis, will likely have a materially adverse effect on our business, financial condition and results of operations.

Other Risks and Uncertainties

 

The Company operates in an industry that is subject to rapid technological change, intense competition, and significant government regulation. The Company’s operations are subject to significant risk and uncertainties including financial, operational, technological and regulatory. Such factors include, but are not necessarily limited to, the results of clinical testing and trial activities, the ability to obtain regulatory approval, the limited supply of raw materials, the ability to obtain favorable licensing, manufacturing or other agreements, including risk associated with our CRE licensing agreement, and the ability to raise capital to achieve strategic objectives.

CRE has entered into a material transfer agreement with the National Cancer Institute of the National Institutes of Health (“NCI”), pursuant to which the NCI has agreed to supply bryostatin required for the Company’s pre-clinical research and clinical trials. This agreement does not provide for a sufficient amount of bryostatin to support the completion of all of the clinical trials that the Company is required to conduct in order to seek U.S. Food and Drug Administration (“FDA”) approval. Therefore, CRE or the Company would have to enter into one or more subsequent agreements with the NCI for the supply of additional amounts of bryostatin. If CRE or the Company were unable to secure such additional agreements, or if the NCI otherwise discontinues the supply, the Company would have to either secure another source of bryostatin or discontinue its efforts to develop and commercialize Bryostatin-1 for the treatment of AD. In June 2020, the Company entered into a supply agreement (the “Supply Agreement”) with BryoLogyx Inc. (“BryoLogyx”), pursuant to which BryoLogyx agreed to be the Company’s exclusive supplier of synthetic bryostatin. Pursuant to the terms of the Supply Agreement, the Company received its initial order of one gram of synthetic bryostatin. See Note 3.

The Company also faces the ongoing risk that the coronavirus pandemic may slow, for an unforeseeable period, the conduct of the Company’s future trials. In order to prioritize patient health and that of the investigators at clinical trial sites, we will monitor enrollment of new patients in our future clinical trials. In addition, some patients may be unwilling to enroll in our trials or be unable to comply with clinical trial protocols if quarantines or travel restrictions impede patient movement or interrupt healthcare services. These and other factors outside of our control could delay our ability to conduct clinical trials or release clinical trial results. In addition, the effects of a pandemic resurgence may also increase non-trial costs such as insurance premiums, increase the demand for and cost of capital, increase loss of work time from key personnel, and negatively impact our key clinical trial vendors and suppliers.

9

Note 2 – Summary of Significant Accounting Policies:

Basis of Presentation:

The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial reporting and with the instructions to Form 10-Q and Article 10 of Regulation S-X. In the opinion of management, the unaudited condensed financial statements included herein contain all adjustments necessary to present fairly the Company’s financial position and the results of its operations and cash flows for the interim periods presented. Such adjustments are of a normal recurring nature. The results of operations for the three and six months ended June 30, 2023 may not be indicative of results for the full year. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and the notes to those statements for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 21, 2023.

Use of Estimates:

The preparation of financial statements in conformity with GAAP requires management to make significant estimates that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Management evaluates its estimates on an ongoing basis using historical experience and other factors, including the general economic environment and actions it may take in the future. The Company adjusts such estimates when facts and circumstances dictate. However, these estimates may involve significant uncertainties and judgments and cannot be determined with precision. In addition, these estimates are based on management’s best judgment at a point in time and as such these estimates may ultimately differ from actual results.

Comprehensive Income (Loss)

The Company follows FASB ASC 220 in reporting comprehensive income (loss). Comprehensive income (loss) is a more inclusive financial reporting methodology that includes disclosure of certain financial information that historically has not been recognized in the calculation of net income (loss). Since the Company has no items of other comprehensive income (loss), comprehensive loss is equal to net loss for all periods presented.

Net Earnings or Loss per Share:

Net earnings or loss per share is computed by dividing net income or loss by the weighted-average number of shares of common stock outstanding during the period, excluding shares subject to redemption or forfeiture. The Company presents basic and diluted net earnings or loss per share. Diluted net earnings or loss per share reflect the actual weighted average of shares of common stock issued and outstanding during the period, adjusted for potentially dilutive securities outstanding. Potentially dilutive securities are excluded from the computation of the diluted net earnings or loss per share if their inclusion would be anti-dilutive.

As all potentially dilutive securities are anti-dilutive as of June 30, 2023 and 2022, diluted net loss per share is the same as basic net loss per share for the three and six months ended June 30, 2023 and 2022.

The weighted average dilutive securities that have been excluded from the calculation of diluted net loss per share for the three and six months ended June 30, 2023 and 2022 respectively, because to do so would be anti-dilutive (in Common Stock equivalents), are as follows:

For the Three Months Ended

For the Six Months Ended

    

June 30,

 

June 30,

2023

2022

2023

2022

Common Stock Options

 

741,850

 

130,000

703,183

128,428

Restricted Stock Units

 

 

495,000

495,000

Convertible Preferred Stock

17,876,707

17,876,707

Common Stock Warrants

 

7,179,919

 

5,487,927

7,179,919

5,855,262

Total

 

25,798,476

 

6,112,927

25,759,809

6,478,690

10

Cash and Cash Equivalents and Concentration of Credit Risk:

The Company considers all highly liquid cash investments with an original maturity of three months or less when purchased to be cash equivalents. At June 30, 2023, the Company’s cash balances that exceed the current insured amounts under the Federal Deposit Insurance Corporation (“FDIC”) were approximately $2.2 million. In addition, approximately $30.7 million included in cash and cash equivalents were invested in a money market fund, which is not insured under the FDIC.

Fair Value of Financial Instruments:

The carrying amounts reflected in the balance sheets for payables approximate fair value due to the short maturities of these instruments. The carrying amounts for warrant liability and derivative liability approximate fair value based on level 3 of the fair value hierarchy.

Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy:

Level 1 — Quoted prices in active markets for identical assets or liabilities.

Level 2 — Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable markets.

Level 3 — Unobservable inputs which are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.

Fixed Assets and Leases:

The Company has two leases, one of which has a term of two years during the respective reporting periods. The Company has deemed the two year lease immaterial and has not recorded it as an obligation on the balance sheet nor a right-of-use asset.  The total future expense relating to this lease is approximately $50,000 per year.

Fixed assets are stated at cost less accumulated depreciation. Depreciation is computed on a straight line basis over the estimated useful life of the asset, which is deemed to be between three and ten years.

Research and Development Costs:

All research and development costs, including costs to maintain or expand the Company’s patent portfolio licensed from CRE are expensed when incurred. Non-refundable advance payments for research and development are capitalized because the right to receive those services represents an economic benefit. Such capitalized advances will be expensed when the services occur and the economic benefit is realized. There were no capitalized research and development services, other than non-refundable advance payments as mentioned below for Worldwide Clinical Trials, Inc. (“WCT”), at June 30, 2023 and December 31, 2022.

Income Taxes:

The Company accounts for income taxes using the asset and liability approach which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and amounts reportable for income tax purposes under the “Separate return method.” Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more-likely-than-not that some portion or all of the deferred tax assets will not be realized.

11

The Company applies the provisions for accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold and measurement process for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The Company has determined that there are no significant uncertain tax positions requiring recognition in the accompanying financial statements. The tax period that is subject to examination by major tax jurisdictions is generally three years from the date of filing.

The Company had federal and state net operating loss carryforwards for income tax purposes of approximately $93.4 million for the period from October 31, 2012 (inception) through June 30, 2023. The net operating loss carryforwards resulted in Federal and state deferred tax asset of approximately $27.4 million at June 30, 2023. Income tax effects of share-based payments are recognized in the financial statements for those awards that will normally result in tax deductions under existing tax law. However, the deferred tax asset is offset by a full valuation allowance.

The Company may be subject to significant U.S. federal income tax-related liabilities with respect to the Spin-Off if there is a determination that the Spin-Off is taxable for U.S. federal income tax purposes. In connection with the Spin-Off, the Company believes that, among other things, the Spin-Off should qualify as a tax-free transaction for U.S. federal income tax purposes under Section 355 and Section 368(a)(1)(D) of the Internal Revenue Code of 1986 (the “Code”). If the conclusions of the tax opinions are not correct, or if the Spin-Off is otherwise ultimately determined to be a taxable transaction, the Company would be liable for U.S. federal income tax related liabilities. Pursuant to the Separation and Distribution Agreement and the Tax Matters Agreement, Neurotrope agreed to indemnify Synaptogenix for certain liabilities, and Synaptogenix agreed to indemnify Neurotrope for certain liabilities, in each case for uncapped amounts. Indemnities that Synaptogenix may be required to provide Neurotrope are not subject to any cap, may be significant and could negatively impact Synaptogenix’s business, particularly with respect to indemnities provided in the Tax Matters Agreement. Third parties could also seek to hold Synaptogenix responsible for any of the liabilities that Neurotrope has agreed to retain. Further, the indemnity from Neurotrope may not be sufficient to protect Synaptogenix against the full amount of such liabilities, and Neurotrope may not be able to fully satisfy its indemnification obligations. Moreover, even if Synaptogenix ultimately succeeds in recovering from Neurotrope any amounts for which Synaptogenix is held liable, Synaptogenix may be temporarily required to bear these losses. At June 30, 2023 and as of the date of financial statement issuance date, the Company does not have any indemnification liabilities.

Under Section 382 of the Code, as amended, changes in the Company’s ownership may limit the amount of its net operating loss carryforwards that could be utilized annually to offset future taxable income, if any. This limitation would generally apply in the event of a cumulative change in ownership of the Company of more than 50% within a three-year period. In addition, the significant historical operating losses incurred by the Company may limit the amount of its net operating loss carryforwards that could be utilized annually to offset future taxable income, if any. The Company believes that operating loss carryforwards are limited under Section 382 limitations although Section 382 studies have not been conducted to determine the actual limitations.

Expense Reimbursement for Grant Award:

The Company reduces its research and development expenses by funding received or receivable from an NIH grant during the period that the expenses are incurred. The Company recognized grant related expense reductions during the six months ended June 30, 2023 of $0 and approximately $100,000 for the three and six months ended June 30, 2022. See Note 5, “Other Commitments – Clinical Trial Services Agreements.”

Of the total $2.7 million available from the NIH grant, the Company has received the maximum reimbursements under the grant as of June 30, 2023.

Recent Accounting Pronouncements:

In August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2020-06, which reduces the number of accounting models for convertible instruments, amends diluted earnings per share calculations for convertible instruments and allows more contracts to qualify for equity classification. ASU 2020-06 will be effective for interim and annual periods beginning after December 15, 2021. The Company has adopted ASU 2020-06 as of January 1, 2022.

12

In June 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). This standard establishes an impairment model (known as the current expected credit loss (“CECL”) model) that is based on expected losses rather than incurred losses. Under the new guidance, an entity recognizes as an allowance its estimate of expected credit losses, which is intended to result in a timelier recognition of losses. Under the CECL model, entities will estimate credit losses over the entire contractual term of the instrument (considering estimated prepayments, but not expected extensions or modifications) from the date of initial recognition of the financial instrument. Measurement of expected credit losses are to be based on relevant forecasts that affect collectability. The scope of financial assets within the CECL methodology is broad and includes trade receivables from certain revenue transactions and certain off-balance sheet credit exposures. Different components of the guidance require modified retrospective or prospective adoption.

In November 2018, the FASB issued ASU No. 2018-19, Codification Improvements to Topic 326, Financial Instruments-Credit Losses. ASU 2018-19 clarifies that receivables arising from operating leases are not within the scope of the credit losses standard. Instead, entities would need to apply other U.S. GAAP, namely Topic 842 (Leases), to account for changes in the collectability assessment for operating leases. Other than operating lease receivables, Partnership trade receivables include receivables from finance leases and equipment sales. Under Topic 606 (Revenue from Contracts with Customers), revenue is recognized when, among other criteria, it is probable that the entity will collect the consideration to which it is entitled for goods or services transferred to a customer. At the point that finance lease receivables are recorded, they become subject to the CECL model and estimates of expected credit losses over their contractual life will be required to be recorded at inception based on historical information, current conditions, and reasonable and supportable forecasts. Trade receivables derived from equipment sales are of short duration and there is not a material difference between incurred losses and expected losses.

In April 2019, the FASB issued ASU 2019-04, Codification Improvements to Topic 326, Financial Instruments-Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments, which amends and clarifies several provisions of Topic 326. In May 2019, the FASB issued ASU 2019-05, Financial Instruments-Credit Losses (Topic 326): Targeted Transition Relief, which amends Topic 326 to allow the fair value option to be elected for certain financial instruments upon adoption. ASU 2019-10 extended the effective date of ASU 2016-13 until December 15, 2022. The Company adopted this new guidance, including the subsequent updates to Topic 326, on January 1, 2023 and the adoption did not have a material impact on the Company’s financial statements and related disclosures.

Note 3– Collaborative Agreements and Commitments:

Stanford License Agreements

On May 12, 2014, the Company entered into a license agreement (the “Stanford Agreement”) with The Board of Trustees of The Leland Stanford Junior University (“Stanford”), pursuant to which Stanford has granted to the Company a revenue-bearing, world-wide right and exclusive license, with the right to grant sublicenses (on certain conditions), under certain patent rights and related technology for the use of bryostatin structural derivatives, known as “bryologs,” for use in the treatment of central nervous system disorders, lysosomal storage diseases, stroke, cardio protection and traumatic brain injury, for the life of the licensed patents. The Company is required to use commercially reasonable efforts to develop, manufacture and sell products (“Licensed Products”) in the Licensed Field of Use (as defined in the Stanford Agreement) during the term of the licensing agreement which expires upon the termination of the last valid claim of any licensed patent under this agreement. In addition, the Company must meet specific product development milestones, and upon meeting such milestones, make specific milestone payments to Stanford. The Company must also pay Stanford royalties of 3% of net sales, if any, of Licensed Products (as defined in the Stanford Agreement) and milestone payments of up to $3.7 million dependent upon stage of product development. As of June 30, 2023, no royalties nor milestone payments have been required.

13

On January 19, 2017, the Company entered into a second license agreement with Stanford, pursuant to which Stanford has granted to the Company a revenue-bearing, world-wide right and exclusive license, with the right to grant sublicenses (on certain conditions), under certain patent rights and related technology for the use of “Bryostatin Compounds and Methods of Preparing the Same,” or synthesized bryostatin, for use in the treatment of neurological diseases, cognitive dysfunction and psychiatric disorders, for the life of the licensed patents. The Company paid Stanford $70,000 upon executing the license and is obligated to pay an additional $10,000 annually as a license maintenance fee. In addition, based upon certain milestones that include product development and commercialization, the Company will be obligated to pay up to an additional $2.1 million and between 1.5% and 4.5% royalty payments on certain revenues generated by the Company relating to the licensed technology. On November 9, 2021, the Company revised the existing licensing agreement with Stanford. The revisions extended all the required future product development and commercialization milestones. The Company is currently in full compliance with the revised agreement and is moving forward on its commitments. As of June 30, 2023, no royalties nor milestone payments have been earned or made.

The Company has advanced the development of synthetic bryostatin by demonstrating the equivalence of the synthetic to the natural bryostatin product. The estimated cost to initiate and produce sufficient quantities of the synthetic bryostatin drug product is approximately $1.5 million. The Company is evaluating production alternatives at this time.

Mt. Sinai License Agreement

On July 14, 2014, the Company entered into an Exclusive License Agreement (the “Mount Sinai Agreement”) with the Icahn School of Medicine at Mount Sinai (“Mount Sinai”). Pursuant to the Mount Sinai Agreement, Mount Sinai granted the Company (a) a revenue-bearing, world-wide right and exclusive license, with the right to grant sublicenses (on certain conditions), under Mount Sinai’s interest in certain joint patents held by the Company and Mount Sinai (the “Joint Patents”) as well as in certain results and data (the “Data Package”) and (b) a non-exclusive license, with the right to grant sublicenses on certain conditions, to certain technical information, both relating to the diagnostic, prophylactic or therapeutic use for treating diseases or disorders in humans relying on activation of Protein Kinase C Epsilon (“PKC ε”), which includes Niemann-Pick Disease (the “Mount Sinai Field of Use”). The Mount Sinai Agreement allows the Company to research, discover, develop, make, have made, use, have used, import, lease, sell, have sold and offer certain products, processes or methods that are covered by valid claims of Mount Sinai’s interest in the Joint Patents or an Orphan Drug Designation Application covering the Data Package (“Mount Sinai Licensed Products”) in the Mount Sinai Field of Use (as such terms are defined in the Mount Sinai Agreement).

The Company is required to pay Mt. Sinai milestone payments of $2.0 million upon approval of a new drug application (“NDA”) in the United States and an additional $1.5 million for an NDA approval in the European Union or Japan. In addition, the Company is required to pay Mt. Sinai royalties on net sales of licensed product of 2.0% for up to $250 million of net sales and 3.0% of net sales over $250 million. Since inception, the Company has paid Mt. Sinai approximately $200,000 consisting of licensing fees of $125,000 plus development costs and patent fees of approximately $75,000. As of June 30, 2023, no royalties nor milestone payments have been required.

Agreements with BryoLogyx

On June 9, 2020, the Company entered into a supply agreement (the “Supply Agreement”) with BryoLogyx Inc. (“BryoLogyx”), pursuant to which BryoLogyx agreed to serve as the Company’s exclusive supplier of synthetic bryostatin. Pursuant to the terms of the Supply Agreement, the Company placed an initial order and subsequently received one gram of current good manufacturing practice (“cGMP”) synthetic bryostatin as an active pharmaceutical ingredient to be used in a drug product (“API”). The Company may place additional orders for API beyond the initial order by making a written request to BryoLogyx no later than six months prior to the requested delivery date. The Company is not currently using synthetic bryostatin for its current Phase 2 clinical trial and will determine when to incorporate the synthetic into the clinical trial process.

14

In connection with the Supply Agreement, on June 9, 2020, the Company entered into a transfer agreement (the “Transfer Agreement”) with BryoLogyx. Pursuant to the terms of the Transfer Agreement, the Company agreed to assign and transfer to BryoLogyx all of the Company’s right, title and interest in and to that certain Cooperative Research and Development Agreement, dated as of January 29, 2019 (the “CRADA”), by and between the Company and the U.S. Department of Health and Human Services, as represented by the NCI, under which Bryostatin-1’s ability to modulate CD22 in patients with relapsed/refractory CD22+ disease has been evaluated to date. Pursuant to guidance provided by NCI, the Company CRADA has been cancelled and BryoLogyx has initiated a request for a new CRADA in its name. BryoLogyx will be filing its own investigational new drug application (“IND”) for CD22 with the FDA. As consideration for the transfer of rights to the CRADA, BryoLogyx has agreed to pay to the Company 2% of the gross revenue received in connection with the sale of bryostatin products, up to an aggregate payment amount of $1 million. No such revenues have been earned as of June 30, 2023.

Nemours Agreement

On September 5, 2018, we announced a collaboration with Nemours A.I. DuPont Hospital (“Nemours”), a premier U.S. children’s hospital, to initiate a clinical trial in children with Fragile X syndrome, a genetic disorder. In addition to the primary objective of safety and tolerability, measurements will be made of working memory, language and other functional aspects such as anxiety, repetitive behavior, executive functioning, and social behavior. On August 5, 2021, the Company announced its memorandum of understanding with Nemours to initiate a clinical trial using Bryostatin-1, under Orphan Drug Status, to treat Fragile X. The Company intends to provide the Bryostatin-1 and obtain the IND, and Nemours intends to provide the clinical site and attendant support for the trial. The Company and Nemours, jointly, will develop the trial protocol. The Company estimates its total trial and IND cost to be approximately $2.0 million. As of June 30, 2023, the Company has incurred cumulative expenses associated with this agreement of approximately $100,000.

The Company has filed an IND with the FDA. The FDA has placed the development of the IND on clinical hold pending completion of further analytics relating to drug pharmacokinetics and pharmacodynamics. The Company is currently evaluating its plans to advance Fragile X development.

Cleveland Clinic

On February 23, 2022, the Company announced its collaboration with the Cleveland Clinic to pursue possible treatments for Multiple Sclerosis (“MS”), and on July 19, 2023, the Company announced that it had entered into an agreement with Cleveland Clinic to conduct a Phase 1 trial of Bryostatin-1 in MS. Cleveland Clinic will manage the clinical trial’s implementation, including an IND submission to the FDA and patient enrollment. The total estimated costs associated with this collaboration are approximately $2.0 million.

Cognitive Research Enterprises, Inc. (“CRE”)

Effective October 31, 2012, the Company executed a Technology License and Services Agreement (the “TLSA”) with CRE, a related party, and NRV II, LLC (“NRV II”), another affiliate of CRE, which was amended by Amendment No. 1 to the TLSA as of August 21, 2013, as amended and restated on February 4, 2015 (the “CRE License Agreement”). Pursuant to the CRE License Agreement, CRE and NRV II provide research services and have granted the Company the exclusive and nontransferable world-wide, royalty-bearing right, with a right to sublicense (in accordance with the terms and conditions described below), under CRE’s and NRV II’s respective right, title and interest in and to certain patents and technology owned by CRE or licensed to NRV II by CRE as of or subsequent to October 31, 2012, to develop, use, manufacture, market, offer for sale, sell, distribute, import and export certain products or services for therapeutic applications for AD and other cognitive dysfunctions in humans or animals (the “Field of Use”). Additionally, the CRE License Agreement specifies that all patents that issue from a certain patent application shall constitute licensed patents and all trade secrets, know-how and other confidential information claimed by such patents constitute licensed technology under the CRE License. The CRE License Agreement terminates on the later of the date (a) the last of the licensed patent expires, is abandoned, or is declared unenforceable or invalid or (b) the last of the intellectual property enters the public domain.

After Neurotrope’s initial Series A Stock financing, the CRE License Agreement required the Company to enter into scope of work agreements with CRE as the preferred service provider for any research and development services or other related scientific assistance and support services. There were no such statements of work agreements entered into during the years ended December 31, 2022 and 2021, respectively, or during the six months ended June 30, 2023.

15

In addition, on November 10, 2018, the Company and CRE entered into a second amendment (the “Second Amendment”) to the TLSA pursuant to which CRE granted certain patent prosecution and maintenance rights to the Company. Under the Second Amendment, the Company will have the sole and exclusive right and the obligation, to apply for, file, prosecute and maintain patents and applications for the intellectual property licensed to the Company, and pay all fees, costs and expenses related to the licensed intellectual property.

Note 4- Related Party Transactions:

On August 4, 2016, Neurotrope entered into a consulting agreement with SM Capital Management, LLC (“SMCM”), a limited liability company owned and controlled by the Company’s Chairman of the Board, Mr. Joshua N. Silverman (the “Consulting Agreement”). Pursuant to the Consulting Agreement, SMCM shall provide consulting services which shall include, but not be limited to, providing business development, financial communications and management transition services, for a one-year period, subject to annual review thereafter. SMCM’s annual consulting fee is $120,000, payable by the Company in monthly installments of $10,000. This contract was assigned to the Company as of December 1, 2020. For the three and six months ended June 30, 2023 and 2022, $30,000 and $60,000 is reflected in the Company’s statements of operations, respectively.

Note 5 – Other Commitments:

Clinical Trial Services Agreements

On July 23, 2020, the Company entered into the 2020 Services Agreement with WCT. The 2020 Services Agreement relates to services for the current Phase 2 clinical trial assessing the safety, tolerability and long-term efficacy of Bryostatin-1 in the treatment of moderately severe AD subjects not receiving memantine treatment (the “2020 Study”).On January 22, 2022, the Company executed a change order with WCT to accelerate trial subject recruitment totaling approximately $1.4 million. In addition, on February 10, 2022, the Company signed an additional agreement with a third-party vendor to assist with the increased trial recruitment retention totaling approximately $1.0 million which was subsequently canceled with no charges incurred by the Company. The updated total estimated budget for the current trial services, including pass-through costs, was approximately $11.0 million. As noted below, Neurotrope was granted a $2.7 million award from the National Institutes of Health, which award was used to support the Phase 2 Study, resulting in an estimated net budgeted cost of the Phase 2 Study to Neurotrope of $9.3 million. Synaptogenix may terminate the 2020 Services Agreement without cause upon 60 days prior written notice.

The Company was awarded a $2.7 million grant from the NIH, which will be used to support the 2020 Study, resulting in an estimated net budgeted cost of the 2020 Study to the Company of $8.3 million. The NIH grant provided for funds in the first year, which began in April 2020, of approximately $1.0 million and funding in year two, which began April 2021, of approximately $1.7 million. As of February 22, 2022, virtually all of the NIH grant has been received and offset against the clinical trial costs. The Company incurred approximately $10.5 million of cumulative expenses associated with the current Phase 2 clinical trial as of June 30, 2023. Of the total $10.5 million incurred for the trial as of June 30, 2023, approximately $77,000 and $0.4 million is reflected in the statement of operations for the three and six months ended June 30, 2023, respectively, and approximately $1.2 million and $4.6 million is reflected in the statement of operations for the three and six months ended June 30, 2022, respectively. As of June 30, 2023 included in the Company’s balance sheet, approximately $131,000 of WCT prepayments is included as a prepaid expense and other current assets. In addition, approximately $171,000 is included in accounts payable and accrued expenses.

On May 12, 2022, the Company entered into a services agreement with WCT (the “2022 Services Agreement”). The 2022 Services Agreement related to services for a Phase 2 “open label,” dose ranging study, clinical trial assessing the safety, tolerability and efficacy of Bryostatin-1 administered via infusion in the treatment of moderately severe to severe AD subjects not receiving memantine treatment (the “2022 Study”).

Pursuant to the terms of the 2022 Services Agreement, WCT provided services to enroll approximately twelve 2022 Study subjects. The first 2022 Study site was initiated during the third quarter of 2022. The total estimated budget for the services, including pass-through costs, is currently approximately $2.0 million. The Company terminated the 2022 Services Agreement in December 2022.

16

The Company incurred approximately $1.6 million of cumulative expenses associated with the current 2022 Study as of June 30, 2023. Of the total $1.6 million incurred for the trial as of June 30, 2023, approximately $33,000 and $157,000 is reflected in the statement of operations for the three and six months ended June 30, 2023, respectively and $0 for the comparable periods in 2022. As of June 30, 2023, $0 of WCT 2022 Study prepayments is included as a prepaid expense and other current assets in the Company’s balance sheet. In addition, approximately $55,000 is included in accounts payable and accrued expenses as of June 30, 2023.

Other Consulting Agreements

Effective as of January 1, 2021, the Company entered into an amended consulting agreement with Katalyst Securities LLC (“Katalyst”) reducing the cash payment to $20,000 per month. Effective as of January 1, 2022, the Company entered into an additional amended consulting agreement with Katalyst reducing the cash payment to $10,000 per month beginning February 1, 2022 through December 31, 2022 and eliminating any further warrant issuances. In addition, on February 16, 2021, Katalyst was granted warrants to purchase 25,000 shares of Common Stock at $11.46 per share; on April 1, 2021, was granted warrants to purchase an additional 4,500 shares of Common Stock at $8.80 per share; on July 1, 2021, was granted warrants to purchase an additional 4,500 shares of Common Stock at $9.76 per share; on October 1, 2021, was granted warrants to purchase an additional 4,500 shares of Common Stock at $9.30 per share; and on January 3, 2022, was granted warrants to purchase an additional 4,500 shares of Common Stock at $8.69 per share. For the three and six months ended June 30, 2023, $0 and $0 is reflected in the Company’s statements of operations, respectively and, for the three and six months ended June 30, 2022, $30,000 and $111,283 is reflected in the Company’s statements of operations, respectively. The Company uses the Black Scholes method to value its warrant issuances to Katalyst. All warrants assume a 0% dividend rate, have a term of five years and are expensed at fair value upon issuance. The Company terminated the Katalyst Agreement in December 2022.

Effective as of January 1, 2021, the Company entered into an amended consulting agreement with GP Nurmenkari, Inc. (“GPN”) (the “GPN Agreement”) reducing the cash payment to $12,000 per month. Effective as of July 1, 2021, the Company entered into a second amended consulting agreement with GPN increasing the cash payment to $20,000 per month and increasing warrants issued for each three-month period beginning July 1, 2021 to 5,800, with the last issuance on October 1, 2021. Effective as of January 1, 2022, the Company entered into an additional amended consulting agreement with GPN reducing the cash payment to $10,000 per month beginning February 1, 2022 through December 31, 2022 and eliminating any further warrant issuances. In addition, on February 16, 2021, GPN was granted warrants to purchase 10,000 shares of Common Stock at $11.46 per share; on April 1, 2021, was granted warrants to purchase an additional 2,500 shares of Common Stock at $8.80 per share; on July 1, 2021, was granted warrants to purchase an additional 5,800 shares of Common Stock at $9.76 per share; on October 1, 2021, was granted warrants to purchase an additional 5,800 shares of Common Stock at $9.30 per share; and on January 3, 2022, was granted warrants to purchase an additional 5,800 shares of Common Stock at $8.69 per share. For the three and six months ended June 30, 2023, $0 and $0 is reflected in the Company’s statements of operations, respectively and, for the comparable periods in 2022, $30,000 and $120,320 is reflected in the Company’s statements of operations, respectively. The Company uses the Black Scholes method to value its warrant issuances to GPN. All warrants assume a 0% dividend rate, have a term of five years and are expensed at fair value upon issuance. The Company terminated the GPN Agreement in December 2022.

Employment Agreements

On December 7, 2020, the Company entered into an offer letter (the “Offer Letter”) with Alan J. Tuchman, M.D., pursuant to which Dr. Tuchman agreed to serve as the Company’s Chief Executive Officer, commencing on December 7, 2020. In addition, in connection with his appointment as the Company’s Chief Executive Officer, Dr. Tuchman was appointed to the board of directors of the Company. Dr. Tuchman receives an annual base salary of $222,000, with an annual discretionary bonus of up to 50% of his base salary then in effect.

The term of Dr. Tuchman’s employment pursuant to the Offer Letter is one year, which shall be extended automatically for six-month periods unless either party gives timely written notice. Dr. Tuchman’s agreement was previously extended until December 7, 2022. On August 4, 2022, the Company entered into an amendment (the “Second Amendment”) to the Offer Letter to extend the term of Dr. Tuchman’s employment through June 7, 2023, and such term shall be extended for an additional six months upon Dr. Tuchman’s written notice to the Company at least 30 days prior to June 7, 2023. Pursuant to the Amendment, if Dr. Tuchman is terminated without Cause (as defined in the Offer Letter), Dr. Tuchman shall be entitled to severance equal to six months of Dr. Tuchman’s annual base salary. Effective June 7, 2023, the Company entered into an additional amendment to the Offer Letter to extend the term of Dr. Tuchman’s employment through June 7, 2024, with automatic monthly renewals thereafter unless earlier terminated in accordance with the terms of the Second Amendment.

17

Other Commitments and Agreements

See Notes 3 and 4 for Collaboration and License Agreement related commitments. 

Contingencies

Pursuant to the Separation Agreement and Tax Matters Agreement with Neurotrope, Neurotrope agreed to indemnify Synaptogenix for certain liabilities, and Synaptogenix agreed to indemnify Neurotrope for certain liabilities, in each case for uncapped amounts. Indemnities that Synaptogenix may be required to provide Neurotrope are not subject to any cap, may be significant and could negatively impact Synaptogenix’s business, particularly with respect to indemnities provided in the Tax Matters Agreement. Third parties could also seek to hold Synaptogenix responsible for any of the liabilities that Neurotrope has agreed to retain. Further, the indemnity from Neurotrope may not be sufficient to protect Synaptogenix against the full amount of such liabilities, and Neurotrope may not be able to fully satisfy its indemnification obligations. Moreover, even if Synaptogenix ultimately succeeds in recovering from Neurotrope any amounts for which Synaptogenix is held liable, Synaptogenix may be temporarily required to bear these losses ourselves. As of the reporting date, there are no claims relating to the indemnification agreement.

Note 6 – Stockholders’ Equity:

The Company’s certificate of incorporation authorizes it to issue 150,000,000 shares of Common Stock and 1,000,000 shares of preferred stock, par value $0.0001 per share.

The holders of Common Stock are entitled to receive dividends out of assets or funds legally available for the payment of dividends at such times and in such amounts as the Board from time to time may determine. To date, the Company has not paid dividends on its Common Stock. Holders of Common Stock are entitled to one vote for each share held on all matters submitted to a vote of stockholders. There is no cumulative voting of the election of directors then standing for election. The Common Stock is not entitled to pre-emptive rights and is not subject to conversion or redemption. Upon liquidation, dissolution or winding up of the Company, the assets legally available for distribution to stockholders are distributable ratably among the holders of Common Stock after payment of liabilities, accrued dividends and liquidation preferences, if any. Each outstanding share of Common Stock is duly and validly issued, fully paid and non-assessable.

November 2022 Private Placement

On November 17, 2022, the Company entered into a Securities Purchase Agreement (as amended on May 11, 2023, the “November Purchase Agreement”) with certain accredited investors (the “November Investors”), pursuant to which it agreed to sell to the November Investors (i) an aggregate of 15,000 shares of the Company’s newly-designated Series B convertible preferred stock with a stated value of $1,000 per share (the “Series B Preferred Stock”), initially convertible into up to 1,935,485 shares of Common Stock at a conversion price of $7.75 per share (the “Series B Preferred Shares”), and (ii) warrants to acquire up to an aggregate of 1,935,485 shares of Common Stock (the “November Warrants”) (collectively, the “November Private Placement”). On May 12, 2023, the Company filed an amendment (the “CoD Amendment”) to the Certificate of Designations with the Secretary of State for the State of Delaware, pursuant to which the Company amended the terms of the Series B Preferred Stock by removing all references to the “Make-Whole Amount”.  In connection with the CoD Amendment, on May 11, 2023, the Company entered into an amendment to the November Purchase Agreement pursuant to which it agreed to extend the investors’ right of participation in a subsequent financing until the one year anniversary following the later of (x) such time that the Preferred Shares are no longer outstanding and (y) the maturity date of the Series B Preferred Stock.

18

The terms of the Series B Preferred Stock are as set forth in the Certificate of Designations for the Series B Preferred Stock (as amended on March 17, 2023 and May 12, 2023, the “Certificate of Designations”). The Series B Preferred Stock will be convertible into Series B Preferred Shares at the election of the holder at any time at an initial conversion price of $7.75 (the “Conversion Price”). The Conversion Price is subject to customary adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based adjustment in the event of any issuances of Common Stock, or securities convertible, exercisable or exchangeable for Common Stock, at a price below the then-applicable Conversion Price (subject to certain exceptions). The Company will be required to redeem the Series B Preferred Stock in 15 equal monthly installments, commencing on June 1, 2023. The amortization payments due upon such redemption are payable, at the Company’s election, in cash, or subject to certain limitations, in shares of Common Stock valued at the lower of (i) the Conversion Price then in effect and (ii) the greater of (A) a 15% discount to the average of the three lowest closing prices of the Common Stock during the thirty trading day period immediately prior to the date the amortization payment is due or (B) the lower of $1.25 and $0.172, which equals 20% of the Minimum Price (as defined in Rule 5635 of the Rule of the Nasdaq Stock Market) on April 14, 2023, the date of receipt of Nasdaq Stockholder Approval (as defined below); provided that if the amount set forth in clause B is the lowest effective price, the Company will be required to pay the amortization payment in cash. The Company may require holders to convert their Series B Preferred Stock into Series B Preferred Shares if the closing price of the Common Stock exceeds $11.625 per share for 20 consecutive trading days and the daily trading volume of the Common Stock exceeds 100,000 shares per day during the same period and certain equity conditions described in the Certificate of Designations are satisfied.

The holders of the Series B Preferred Stock will be entitled to dividends of 7% per annum, compounded monthly, which will be payable in cash or shares of Common Stock at the Company’s option, in accordance with the terms of the Certificate of Designations. Upon the occurrence and during the continuance of a Triggering Event (as defined in the Certificate of Designations), the Series B Preferred Stock will accrue dividends at the rate of 15% per annum. The holders of Series B Preferred Stock have no voting rights on account of the Series B Preferred Stock, other than with respect to certain matters affecting the rights of the Series B Preferred Stock.

Notwithstanding the foregoing, the Company’s ability to settle conversions and make amortization payments using shares of Common Stock is subject to certain limitations set forth in the Certificate of Designations, including a limit on the number of shares that may be issued until the time, if any, that the Company’s stockholders have approved the issuance of more than 19.9% of the Company’s outstanding shares of Common Stock in accordance with Nasdaq listing standards (the “Nasdaq Stockholder Approval”). The Company agreed to seek stockholder approval of these matters at a meeting to be held no later than June 1, 2023, and such approval was obtained at the Company’s special meeting of stockholders held on April 14, 2023. Further, the Certificate of Designations contains a certain beneficial ownership limitation after giving effect to the issuance of shares of Common Stock issuable upon conversion of, or as part of any amortization payment under, the Certificate of Designations or November Warrants.

The Certificate of Designations includes certain Triggering Events (as defined in the Certificate of Designations), including, among other things, the failure to file and maintain an effective registration statement covering the sale of the holder’s securities registrable pursuant to the November Registration Rights Agreement (defined below) and the Company’s failure to pay any amounts due to the holders of the Series B Preferred Stock when due. In connection with a Triggering Event, each holder of Series B Preferred Stock will be able to require the Company to redeem in cash any or all of the holder’s Series B Preferred Stock at a premium set forth in the Certificate of Designations.

The Company will be subject to certain affirmative and negative covenants regarding the incurrence of indebtedness, acquisition and investment transactions, the existence of liens, the repayment of indebtedness, the payment of cash in respect of dividends (other than dividends pursuant to the Certificate of Designations), distributions or redemptions, and the transfer of assets, among other matters.

The November Warrants are exercisable for Warrant Shares immediately at an exercise price of $7.75 per share (the “Exercise Price”) and expire five years from the date of issuance. The Exercise Price is subject to customary adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based adjustment, on a “full ratchet” basis, in the event of any issuances of Common Stock, or securities convertible, exercisable or exchangeable for Common Stock, at a price below the then-applicable Exercise Price (subject to certain exceptions). There is no established public trading market for the November Warrants and the Company does not intend to list the November Warrants on any national securities exchange or nationally recognized trading system.

19

In connection with the November Purchase Agreement, the Company and the November Investors entered into a Registration Rights Agreement (the “November Registration Rights Agreement”) on November 17, 2022. Under the terms of the November Registration Rights Agreement, the Company agreed to register 200% of the Series B Preferred Shares, the Warrant Shares and the shares of Common stock issuable as amortization payments as well as any shares of Common stock paid as dividends. The Company filed a registration statement for the resale of such securities on December 16, 2022. The Company also agreed to other customary obligations regarding registration, including indemnification and maintenance of the effectiveness of the registration statement.

In connection with the November Private Placement, pursuant to an Engagement Letter, between the Company and Katalyst Securities LLC (the “November Placement Agent”), the Company paid the November Placement Agent (i) a cash fee equal to 7% of the gross proceeds from any sale of securities in the November Private Placement and (ii) warrants to purchase shares of Common Stock equal to 3% of the number of shares of Common stock that the Series B Preferred Shares are initially convertible into, with an exercise price of $7.75 per share and a five-year term.

On June 1, 2023, the Company paid the holders of the Series B Preferred Stock approximately $1.64 million to satisfy the first amortization payment due. On June 30, 2023, the holders of the Series B Preferred Stock elected to defer the cash payment due on July 1, 2023 of approximately $1.14 million to August 1, 2023.  On July 13, 2023, the holders of the Series B Preferred Stock elected to convert cash payments due on August 1, 2023 of approximately $2.16 million into 3,125,907 shares of Common Stock. On July 31, 2023, the holders of the Series B Preferred Stock elected to defer cash payments due on August 1, 2023 of approximately $953,000 to September 1, 2023. On August 1, 2023, the Company provided notice to the Series B Preferred Stock investors that it would issue 1,680,675 shares of pre-amortization Common Stock to satisfy the amortization payment due September 1, 2023. As of August 10, 2023, 2,799,249 total shares of Common Stock have been issued to the holders of the Series B Preferred Stock.

Accounting Treatment of November Private Placement

Series B Preferred Shares

Effective April 14, 2023, the Company amended the Certificate of Designations of Series B Convertible Preferred Stock. The amendment modified (i) the definition of Floor Price to mean the lower of (i) $1.25 and (ii) 20% of the “Minimum Price” (as defined in Rule 5635 of the Rule of the Nasdaq Stock Market) on the date of receipt of Stockholder Approval (as defined in the Agreement), (ii) the definition of Installment Date to mean June 1, 2023, and thereafter, the first Trading Day of each calendar month immediately following the previous Installment Date until the Maturity Date, and the Maturity Date, and (iii) the definition of Maturity Date to mean August 31, 2023. In accordance with ASC 470-50 and 470-60, the Company has made an accounting policy election to account for amendments of the Series B Preferred Stock as modifications or extinguishments based on the change in fair value of the instrument immediately before and immediately after the amendment. The Company accounted for the amendment as an extinguishment as the change in fair value of the Series B Preferred Stock was 34% (greater than ten percent (10%)) immediately before and immediately after. In accordance with ASC 260-10-S99-2, the Company recognized the $5.7 million increase in fair value as a deemed dividend on the statement of operations.

On May 11, 2023, the Company amended the Certificate of Designations of Series B Convertible Preferred Stock. The amendment removed the definition of Make-Whole Amount (as was previously defined in the Agreement) and modified the definition of the Conversion Amount so as to remove the Make-Whole Amount from said definition. In accordance with ASC 470-50 and 470-60, the Company accounted for the amendment as a modification as the change in fair value of the Series B Preferred Stock was 0.05% (less than ten percent (10%)) immediately before and immediately after. The Company analogized to the share-based payments model for the appropriate modification accounting and did not recognize a deemed dividend as the fair value decreased upon modification.

20

The Series B Preferred Shares were determined to be more akin to a debt-like host than an equity-like host. The Company identified the following embedded features that are not clearly and closely related to the debt host instrument: 1) make-whole interest upon a contingent redemption event, 2) make-whole interest upon a conversion event, 3) an installment redemption upon an Equity Conditions Failure (as defined in the Certificate of Designation), and 4) variable share-settled installment conversion. These features were bundled together, assigned probabilities of being affected and measured at fair value. Subsequent changes in fair value of these features are recognized in the Consolidated Statement of Operations. The Company estimated the $2.2 million fair value of the bifurcated embedded derivative at issuance using a Monte Carlo simulation model, with the following inputs: the fair value of our Common stock of $6.52 on the issuance date, estimated equity volatility of 85.0%, estimated traded volume volatility of 255.0%, the time to maturity of 1.61 years, a discounted market interest rate of 7.3%, dividend rate of 7%, a penalty dividend rate of 15.0%, and probability of default of 8.2%. The fair value of the bifurcated derivative liability was estimated utilizing the with and without method which uses the probability weighted difference between the scenarios with the derivative and the plain vanilla maturity scenario without a derivative.

The discount to the fair value is included as a reduction to the carrying value of the Series B Preferred Shares. During 2022, the Company recorded a total discount of approximately $12.3 million upon issuance of the Series B Preferred Shares, which was comprised of the issuance date fair value of the associated embedded derivative of approximately $2.2 million, stock issuance costs of approximately $0.5 million and the fair value of the Warrants of approximately $9.6 million. During the three months ended June 30, 2023, it was deemed probable that the Series B Preferred Shares will be redeemed for cash upon Installment Redemptions (as defined the Certificate of Designation). As such, the Company recognized $2,455,656 to additional paid-in capital to accrete the Series B Preferred Shares to redemption amount pursuant to ASC 480-10-S99-3A with a corresponding increase in the carrying value of the Series B Preferred Shares.

During the three and six months ended June 30, 2023, the Company recorded a loss of $2,484,400 and $2,258,600, respectively, and $0 for the comparable periods in 2022, related to the change in fair value of the derivative liability which is recorded in other income (expense) on the Statements of Operations. The Company estimated the $2,628,000 fair value of the bifurcated embedded derivative at June 30, 2023 using a Monte Carlo simulation model, with the following inputs: the fair value of our Common stock of $0.93 per share on the valuation date, estimated equity volatility of 145%, estimated traded volume volatility of 240%, the time to maturity of 1.7 years, a discounted market interest rate of 6.5%, dividend rate of 7%, a penalty dividend rate of 15.0%, and probability of default of 0.9%.

Common Stock Warrants

Pursuant to the Private Placement, the Company issued to investors Warrants and, pursuant to its advisory agreements, the Company issued to its advisor additional Warrants with the same terms. The Broker Warrants are within the scope of ASC 718 pursuant to ASC 718-10-20 but are subject to liability classification as they would be required to be classified as liabilities in accordance with ASC 480.

The Warrants were determined to be within the scope of ASC 480-10 as they are puttable to the Company at Holders’ election upon the occurrence of a Fundamental Transaction (as defined in the agreements). As such, the Company recorded the Warrants as a liability at fair value with subsequent changes in fair value recognized in earnings. The Company utilized the Black Scholes Model to calculate the value of these warrants issued during the year ended December 31, 2022. The fair value of the Warrants of approximately $9.9 million was estimated at the date of issuance using the following weighted average assumptions: dividend yield 0%; expected term of five years; equity volatility of 105%; and a risk-free interest rate of 3.97%.

Transaction costs incurred attributable to the issuance of the Warrants of $0.9 million were immediately expensed in accordance with ASC 480.

During the three and six months ended June 30, 2023 and 2022, the Company recorded a loss of $207,000 and a gain of $381,000, respectively, and $0 for comparable periods in 2022, related to the change in fair value of the warrant liability which is recorded in other income (expense) on the Statements of Operations. The fair value of the Warrants of approximately $1,129,000 was estimated at June 30, 2023 utilizing the Black Scholes Model using the following weighted average assumptions: dividend yield 0%; remaining term of 4.38 years; equity volatility of 130%; and a risk-free interest rate of 4.24%.

21

Note 7 – Stock Based Compensation:

 

2020 Equity Incentive Plan

 

Upon completion of the Spin-Off, the Company’s 2020 Equity Incentive Plan (the “2020 Plan”) became effective on December 7, 2020. The total number of securities available for grant under the 2020 Plan was 250,000 shares of Common Stock, subject to adjustment. On April 7, 2021, the Company held a special meeting of stockholders at which the Company’s stockholders approved an amendment to the Company’s 2020 Plan to increase the total number of shares of Common Stock from 250,000 to an aggregate of 625,000. On October 11, 2022, the Company held its annual meeting of stockholders at which the Company’s stockholders approved an amendment to the Company’s 2020 Plan to increase the total number of shares of Common Stock authorized for issuance from 625,000 to an aggregate of 1,375,000 shares.

The Compensation Committee of the Company’s board of directors (the “Committee”) administers the 2020 Plan and has full power to grant stock options and Common Stock, construe and interpret the 2020 Plan, establish rules and regulations and perform all other acts, including the delegation of administrative responsibilities, as it believes reasonable and proper. The Committee, in its absolute discretion, may award Common Stock to employees, consultants, and directors of the Company, and such other persons as the Committee may select, and permit holders of options to exercise such options prior to full vesting.

Stock and Option Grants

The following is a summary of stock option activity under the stock option plans for the three months ended June 30, 2023:

    

    

    

Weighted-

    

Average

Aggregate

Weighted-

Remaining

Intrinsic

Number

Average

Contractual

Value

of

Exercise

Term

(in

Shares

Price

(Years)

millions)

Options outstanding at January 1, 2023

 

661,850

$

7.27

 

9.5

$

Options granted

 

80,000

$

0.87

 

10.0

 

Less options forfeited

 

$

 

 

Less options expired/cancelled

 

$

 

 

Less options exercised

 

$

 

 

Options outstanding at June 30, 2023

 

741,850

$

6.15

 

9.1

$

Options exercisable at June 30, 2023

 

661,850

$

6.08

 

9.0

$

The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying awards and the closing stock price of $0.923 for the Company’s common shares on June 30, 2023 and the closing stock price of $1.16 for the Company’s common shares on December 31, 2022.

As of June 30, 2023, the Company had unrecognized stock option expense of approximately $45,000 and a remaining weighted average period for recognition of 0.75 years.

On February 16, 2022, pursuant to its 2020 Plan, the Company granted stock options to purchase an aggregate of 6,150 shares of Common Stock to its Chief Executive Officer. The stock options have an exercise price of $7.29 per share and an expiration date that is ten years from the date of issuance. As of February 16, 2023, these stock options are fully vested. The Company used the Black Scholes valuation method to determine the fair value of the options assuming the following: implied volatility of 112.75%, a risk free interest rate of 2.05% and a fair value of $42,108. The options were expensed over the one-year vesting period from date of issuance.

On November 15, 2022, pursuant to its 2020 Plan, the Company granted stock options to six Board members, including two officers who are also Board members, and two employees to purchase an aggregate of 531,850 shares of Common Stock. The stock options have an exercise price of $6.07 per share and an expiration date that is ten years from the date of issuance. 50% of the options vest upon issuance with the remaining 50% vesting on May 15, 2023. The Company used the Black Scholes valuation method to determine the fair value of the options assuming the following: implied volatility of 107.05%, a risk free interest rate of 3.93% and have a fair value of $2,570,328. The options are being expensed 50% at date of issuance and the remaining 50% expensed on a straight line basis over the six-month vesting period from date of issuance.

22

On March 29, 2023, Synaptogenix granted stock options to four Board members to purchase an aggregate of 80,000 shares of common stock. The stock options have an exercise price of $.87 per share and an expiration date of ten years. They vest on the one-year anniversary from the date of the grant. The Company used the Black Scholes valuation method to determine the fair value of the options assuming the following: implied volatility of 123.92%, a risk free interest rate of 3.66% and have a fair value of $59,763.

Director’s Compensation Policy

On March 29, 2023, Synaptogenix adopted an amended and restated non-employee director compensation policy (the “Director Compensation Policy”). The Director Compensation Policy provides for the annual automatic grant of nonqualified stock options to purchase up to 20,000 shares of Synaptogenix’s Common Stock to each of Synaptogenix’s non-employee directors. Such grants shall occur annually on the fifth business day after the filing of Synaptogenix’s Annual Report on Form 10-K, if available under the Plan, and shall vest on the one-year anniversary from the date of grant, subject to the director’s continued service on the Board of Directors on the vesting date. Each newly appointed or elected director will also receive 20,000 options, and such options shall vest 50% on the grant date, 25% on the first anniversary of the grant date and 25% on the second anniversary of the grant date, subject to the director’s continued service on the Board of Directors on each vesting date.

The Company recorded total expenses relating to the outstanding stock options of $334,416 and $979,207 for the three and six months ended June 30, 2023, and $11,544 and $47,918 for the three and six months ended June 30, 2022, respectively.

Restricted Stock Unit Grants

On July 13, 2021, the Company granted a total of 495,000 restricted stock units (RSUs), of which 425,000 were granted to seven Board members (including two executives), 60,000 to the Company’s CFO and 10,000 to two employees. On November 30, 2022, one director and one officer forfeited a total of 86,000 RSUs to satisfy the 2020 Plan limitation of total issuances per year to any individual holder. The Company reversed approximately $370,000 of expense resulting from the forfeited RSUs. The RSUs were amended on January 12, 2022, to vest 100% on September 15, 2022 and then further amended on June 20, 2022 to vest 100% on the earlier of release of Phase 2 clinical trial top line data or December 31, 2022. Top line data was announced on December 16, 2022, and so the RSUs vested on such date.

As of December 31, 2022, 100% of the 411,000 RSUs vested and were exercised. As of June 30, 2023 and December 31, 2022, the Company had unrecognized stock option and RSU expense of approximately $0 and $2.56 million, respectively. The fair value of the RSUs issued was based upon the closing trading price of the Company’s Common stock on the grant date of $9.75 per share. The grant date fair value of the RSUs granted was approximately $4.8 million. The Company recorded total expense, using straight line method over the vesting period of the RSUs, of $0 for the six months ended June 30, 2023 and $1,005,146 and $1,680,330 relating to the RSUs for the three and six months ended June 30, 2022, respectively.

Restricted Stock Issuances

On February 15, 2022, the Company granted 13,775 shares of restricted stock to two consultants that were engaged to provide investor relations services with a total fair market value on date of issuance of $91,429. On March 14, 2022, the Company granted 692 shares of restricted stock to a consultant that was engaged to provide investor relations services with a total fair market value on date of issuance of $4,500. On June 7, 2022, the Company granted 679 shares of restricted stock to a consultant that was engaged to provide investor relations services with a total fair market value on date of issuance of $4,500. On July 8, 2022, the Company granted 30,303 shares of restricted stock to a consultant that was engaged to provide investor relations services with a total fair market value on date of issuance of $150,000 and warrants to purchase 15,459 shares of Common Stock with an exercise price of $13.26 per share for a period of five years from the date of issuance. The Company used the Black Scholes valuation method to determine fair value assuming the following: implied volatility of 112.75%, a risk free interest rate of 3.05% and a fair value of $75,000. The warrants are expensed over the three-month term of the consulting agreement. On September 8, 2022, the Company issued 540 shares of restricted stock to a consultant that was engaged to provide investor relations services with a total fair market value on date of issuance of $4,500. All stock issuances are expensed upon issuance.

On October 8, 2022, the Company issued 6,878 shares of restricted stock to a consultant that was engaged to provide investor relations services with a total fair market value on date of issuance of $50,000 and warrants to purchase 4,659 shares of Common Stock with an exercise price of $14.54 per share for a period of five years from the date of issuance. The Company used the Black Scholes valuation method to determine fair value assuming the following: implied volatility of 112.75%, a risk free interest rate of 4.14%, a fair

23

value of $25,000 and are expensed upon issuance. During November 2022, the Company issued to Sherwood 7,092 shares of restricted Common Stock valued at $50,000 and were expensed when issued, and warrants to purchase 4,795 shares of Common Stock, with an exercise price of $14.10 per share. The Company used the Black Scholes valuation method to determine fair value assuming the following: implied volatility of 112.75%, a risk free interest rate of 4.39% and a fair value of $25,000. The warrants are expensed when issued. On December 7, 2022, the Company issued 893 shares of restricted stock to a consultant that was engaged to provide investor relations services with a total fair market value on date of issuance of $4,501, expensed upon issuance.

On January 5, 2023, the Company issued 88,339 shares of restricted stock to a consultant that was engaged to provide investor relations services with a total fair market value on date of issuance of $100,000. On March 22, 2023, the Company issued 4,500 shares of restricted stock to a consultant that was engaged to provide investor relations services with a total fair market value on date of issuance of $4,500, expensed upon issuance. On June 7, 2023, the Company issued 5,409 shares of restricted stock to a consultant that was engaged to provide investor relations services with a total fair market value on date of issuance of $4,500, expensed upon issuance.

Stock Compensation Expense

Total stock-based compensation for the three and six months ended June 30, 2023 was $334,416 and 979,197, respectively, of which $49,863 and $149,589, respectively, was classified as research and development expense, and $284,553 and $829,608 was classified as general and administrative expense, respectively. Total stock-based compensation for the three and six months ended June 30, 2022 was $1,016,690 and $1,728,248, respectively, of which $172,601 and $293,651, respectively, was classified as research and development expense, and $844,089 and $1,434,597 was classified as general and administrative expense, respectively.

The Company currently estimates, beginning at the closing date of the November Private Placement, implied volatility factor for all options and warrants based upon a blend of the Parent Company’s and Company’s historical volatility. Up until November 21, 2022, the Company computed implied volatility based upon a blend of the Parent Company’s and Company’s historical volatility along with the volatility of selected comparable publicly traded companies as, at that time, the Company lacked sufficient historical stock trading activity. It incorporated the historical volatility of the Parent Company as the Parent Company’s historical volatility provides a good estimation of the Company’s volatility since its operations were identical to the Company’s prior to the spin-out.

Note 8 – Common Stock Warrants:

 

As of June 30, 2023, the Company had warrants outstanding consisting of the following:

    

Number

of shares

Warrants outstanding January 1, 2022

 

6,265,525

Warrants issued

 

2,028,762

Warrants exercised

 

(65,000)

Warrants expired

(1,049,368)

Warrants outstanding and exercisable December 31, 2022 and June 30, 2023

 

7,179,919

On January 3, 2022, pursuant to its advisory agreements, the Company issued warrants to purchase 10,300 shares of Common Stock, with an exercise price of $8.96 per share, for a period of five years from the issuance date. The Company used the Black-Scholes valuation model to calculate the value of these warrants issued to advisors during the year ended December 31, 2022. The fair value of the warrants was estimated at the date of issuance using the following weighted average assumptions: Dividend yield 0%; Expected term five years; weighted average implied volatility of 111.8%; and a weighted average Risk-free interest rate of 2.38%. The total expense recorded during the three and six months ended June 30, 2023 was $0 and $71,603, respectively.

On November 22, 2022, pursuant to the November Private Placement (See Note 6 above), the Company issued warrants to purchase 1,993,485 shares of Common Stock, immediately exercisable with at an exercise price of $7.75 per share and expiring five years from the date of issuance. The Exercise Price is subject to customary adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based adjustment, on a “full ratchet” basis, in the event of any issuances of Common Stock, or securities convertible, exercisable or exchangeable for Common Stock, at a price below the then-applicable Exercise Price (subject to certain exceptions). The fair value of the warrants was estimated at the date of issuance using the following weighted average assumptions: Dividend yield 0%, Expected term five years; weighted average implied volatility of 105% and a weighted average Risk-free interest

24

rate of 3.97%. The total value recorded during the year period, classified as a liability on the Company’s balance sheet in November 2022, is approximately $9.6 million. As of June 30, 2023, the liability is $1,129,000.

As of June 30, 2023, the weighted average exercise price and the weighted average remaining life of the total warrants were $11.79 per warrant and 3.17 years, respectively. The intrinsic value of the warrants as of June 30, 2023 was approximately $134,800. The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying awards and the closing stock price of $0.928 for the Company’s common shares on June 30, 2023.

During the six months ended June 30, 2022, three affiliated warrant holders exercised 50,000 Series E Warrants to purchase 50,000 shares of Common Stock at $8.51 per share and one holder exercised 15,000 Series G Warrants to purchase 15,000 shares of Common Stock at $8.51 per share. During the three months ended June 30, 2022, no warrant holders exercised warrants. Total cash proceeds from these warrant exercises was $553,150. During the three and six months ended June 30, 2023, no warrant holders exercised warrants.

Note 9 - Fair Value Measurements

Fair value measurements discussed herein are based upon certain market assumptions and pertinent information available to management as of and during the six months ended June 30, 2023 and 2022. The carrying amounts of cash equivalents, accounts receivable, other current assets, other assets, accounts payable, and accrued expenses approximated their fair values as of June 30, 2023 and December 31, 2022 due to their short-term nature. The fair value of the bifurcated embedded derivative related to the convertible preferred stock was estimated using a Monte Carlo simulation model, which uses as inputs the fair value of our Common stock and estimates for the equity volatility and traded volume volatility of our Common stock, the time to maturity of the convertible preferred stock, the risk-free interest rate for a period that approximates the time to maturity, dividend rate, a penalty dividend rate, and our probability of default. The fair value of the warrant liability was estimated using the Black Scholes Model which uses as inputs the following weighted average assumptions, as noted above: dividend yield, expected term in years, equity volatility, and risk-free interest rate.

Fair Value on a Recurring Basis

The Company follows the guidance in ASC 820 for its financial assets and liabilities that are re-measured and reported at fair value at each reporting period, and non-financial assets and liabilities that are re-measured and reported at fair value at least annually. The estimated fair value of the warrant liability and bifurcated embedded derivatives represent Level 3 measurements. The following table presents information about the Company’s liabilities that are measured at fair value on a recurring basis at June 30, 2023 and December 31, 2022, and indicates the fair value hierarchy of the valuation inputs the Company utilized to determine such fair value:

June 30,

December 31,

Description

    

Level

    

2023

    

2022

Liabilities:

 

  

 

  

 

  

Warrant liability (Note 6)

 

3

$

1,129,000

$

1,510,000

Bifurcated embedded derivative liability (Note 6)

 

3

$

2,628,000

$

370,300

The following table sets forth a summary of the change in the fair value of the warrant liability that is measured at fair value on a recurring basis:

    

December 31, 2022

Balance on December 31, 2021

$

Issuance of warrants

 

9,915,000

Change in fair value of warrant liability

 

(8,405,000)

Balance on December 31, 2022

$

1,510,000

Change in fair value of warrant liability

 

(381,000)

Balance on June 30, 2023

$

1,129,000

The following table sets forth a summary of the change in the fair value of the bifurcated embedded derivative liability that is measured at fair value on a recurring basis:

25

    

December 31, 2022

Balance on December 31, 2021

$

Issuance of convertible preferred stock with bifurcated embedded derivative

 

2,191,300

Change in fair value of bifurcated embedded derivative

 

(1,821,900)

Balance on December 31, 2022

$

369,400

Change in fair value of warrant liability

 

2,258,600

Balance on June 30, 2023

$

2,628,000

Note 10 – Subsequent Events

See Note 6 above.

26

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes appearing elsewhere in this report. In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those discussed in the section titled “Risk Factors” included elsewhere in this report and our annual report on Form 10-K for the year ended December 31, 2022.

The following discussion highlights our results of operations and the principal factors that have affected our financial condition as well as our liquidity and capital resources for the periods described, and provides information that management believes is relevant for an assessment and understanding of the statements of financial condition and results of operations presented herein. The following discussion and analysis are based on the unaudited financial statements contained in this report, which we have prepared in accordance with United States generally accepted accounting principles. You should read the discussion and analysis together with such financial statements and the related notes thereto.

Basis of Presentation

The unaudited financial statements for the six months ended June 30, 2023 and 2022 include a summary of our significant accounting policies and should be read in conjunction with the discussion below and our financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q. In the opinion of management, all material adjustments necessary to present fairly the results of operations for such periods have been included in the financial statements. All such adjustments are of a normal recurring nature.

Overview

We are a biopharmaceutical company with product candidates in pre-clinical and clinical development. We began operations in October 2012. We are principally focused on developing a product platform based upon a drug candidate called Bryostatin-1 for the treatment of Alzheimer’s disease, which is in the clinical testing stage. We are also evaluating Bryostatin-1 for other neurodegenerative or cognitive diseases and dysfunctions, such as Fragile X syndrome, Multiple Sclerosis, and Niemann-Pick Type C disease, which have undergone pre-clinical testing.

Neurotrope, our predecessor company, had been a party to a technology license and services agreement with the original Blanchette Rockefeller Neurosciences Institute (which has been known as Cognitive Research Enterprises, Inc. since October 2016), and its affiliate NRV II, LLC, which we collectively refer to herein as “CRE,” pursuant to which we now have an exclusive non-transferable license to certain patents and technologies required to develop our proposed products. We were formed for the primary purpose of commercializing the technologies initially developed by BRNI for therapeutic applications for AD or other cognitive dysfunctions. These technologies have been under development by BRNI since 1999 and, until March 2013, had been financed through funding from a variety of non-investor sources (which include not-for-profit foundations, the NIH, which is part of the U.S. Department of Health and Human Services, and individual philanthropists). From March 2013 forward, development of the licensed technology has been funded principally through us in collaboration with CRE.

November 2022 Private Placement

On November 17, 2022, we entered into the November Purchase Agreement with the November Investors, pursuant to which we agreed to sell to the November Investors (i) an aggregate of 15,000 shares of Series B Preferred Stock and (ii) November Warrants to acquire up to an aggregate of 1,935,485 shares of Common Stock. We received total gross proceeds of approximately $15 million from the November Private Placement.

27

The terms of the Series B Preferred Stock are as set forth in the Certificate of Designations. The Series B Preferred Stock will be convertible into Series B Preferred Shares at the election of the holder at any time at the Conversion Price. The Conversion Price is subject to customary adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based adjustment in the event of any issuances of Common Stock, or securities convertible, exercisable or exchangeable for Common Stock, at a price below the then-applicable Conversion Price (subject to certain exceptions). We will be required to redeem the Series B Preferred Stock in 15 equal monthly installments, commencing on June 1, 2023. The amortization payments due upon such redemption are payable, at our election, in cash, or subject to certain limitations, in shares of Common Stock valued at the lower of (i) the Conversion Price then in effect and (ii) the greater of (A) a 15% discount to the average of the three lowest closing prices of the Common Stock during the thirty trading day period immediately prior to the date the amortization payment is due or (B) the lower of $1.25 and $0.172, which is equal to 20% of the Minimum Price (as defined in Rule 5635 of the Rule of the Nasdaq Stock Market) on April 14, 2023, the date of receipt of Nasdaq Stockholder Approval (as defined below); provided that if the amount set forth in clause B is the lowest effective price, we will be required to pay the amortization payment in cash. We may require holders to convert their Series B Preferred Stock into Series B Preferred Shares if the closing price of the Common Stock exceeds $11.625 per share for 20 consecutive trading days and the daily trading volume of the Common Stock exceeds 100,000 shares per day during the same period and certain equity conditions described in the Certificate of Designations are satisfied.

The holders of the Series B Preferred Stock are entitled to dividends of 7% per annum, compounded monthly, which are payable in cash or shares of Common Stock at our option, in accordance with the terms of the Certificate of Designations. Upon the occurrence and during the continuance of a Triggering Event (as defined in the Certificate of Designations), the Series B Preferred Stock will accrue dividends at the rate of 15% per annum. The holders of Series B Preferred Stock have no voting rights on account of the Series B Preferred Stock, other than with respect to certain matters affecting the rights of the Series B Preferred Stock.

Notwithstanding the foregoing, our ability to settle conversions and make amortization payments using shares of Common Stock is subject to certain limitations set forth in the Certificate of Designations, including a limit on the number of shares that may be issued until the time, if any, that our stockholders have approved the issuance of more than 19.9% of our outstanding shares of Common Stock in accordance with Nasdaq listing standards (the “Nasdaq Stockholder Approval”). We agreed to seek stockholder approval of these matters at a meeting to be held no later than June 1, 2023, and such approval was obtained at the Company’s special meeting of stockholders held on April 14, 2023. Further, the Certificate of Designations contains a certain beneficial ownership limitation after giving effect to the issuance of shares of Common Stock issuable upon conversion of, or as part of any amortization payment under, the Certificate of Designations or November Warrants.

The Certificate of Designations includes certain Triggering Events (as defined in the Certificate of Designations), including, among other things, the failure to file and maintain an effective registration statement covering the sale of the holder’s securities registrable pursuant to the November Registration Rights Agreement (defined below) and our failure to pay any amounts due to the holders of the Series B Preferred Stock when due. In connection with a Triggering Event, each holder of Series B Preferred Stock will be able to require us to redeem in cash any or all of the holder’s Series B Preferred Stock at a premium set forth in the Certificate of Designations.

We are subject to certain affirmative and negative covenants regarding the incurrence of indebtedness, acquisition and investment transactions, the existence of liens, the repayment of indebtedness, the payment of cash in respect of dividends (other than dividends pursuant to the Certificate of Designations), distributions or redemptions, and the transfer of assets, among other matters.

The November Warrants are exercisable for Warrant Shares immediately at an exercise price of $7.75 per share (the “Exercise Price”) and expire five years from the date of issuance. The Exercise Price is subject to customary adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based adjustment, on a “full ratchet” basis, in the event of any issuances of Common Stock, or securities convertible, exercisable or exchangeable for Common Stock, at a price below the then-applicable Exercise Price (subject to certain exceptions).

In connection with the November Purchase Agreement, we and the November Investors entered into a Registration Rights Agreement (the “November Registration Rights Agreement”) on November 17, 2022. Under the terms of the November Registration Rights Agreement, we agreed to register 200% of the Series B Preferred Shares, the Warrant Shares and the shares of Common stock issuable as amortization payments as well as any shares of Common stock paid as dividends. We filed a registration statement for the resale of such securities on December 16, 2022. We also agreed to other customary obligations regarding registration, including indemnification and maintenance of the effectiveness of the registration statement.

28

In connection with the November Private Placement, pursuant to an Engagement Letter, between the Company and Katalyst Securities LLC (the “November Placement Agent”), the Company paid the November Placement Agent (i) a cash fee equal to 7% of the gross proceeds from any sale of securities in the November Private Placement and (ii) warrants to purchase shares of Common Stock equal to 3% of the number of shares of Common stock that the Series B Preferred Shares are initially convertible into, with an exercise price of $7.75 per share and a five-year term.

On June 1, 2023, the Company paid the holders of the Series B Preferred Stock approximately $1.64 million to satisfy the first amortization payment due. On June 30, 2023, the holders of the Series B Preferred Stock elected to defer the cash payment due on July 1, 2023 of approximately $1.14 million to August 1, 2023.  On July 13, 2023, the holders of the Series B Preferred Stock elected to convert cash payments due on August 1, 2023 of approximately $2.16 million into 3,125,907 shares of Common Stock. On July 31, 2023, the holders of the Series B Preferred Stock elected to defer cash payments due on August 1, 2023 of approximately $953,000 to September 1, 2023. On August 1, 2023, the Company provided notice to the Series B Preferred Stock investors that it would issue 1,680,675 shares of pre-amortization Common Stock to satisfy the amortization payment due September 1, 2023. As of August 10, 2023, 2,799,249 total shares of Common Stock have been issued to the holders of the Series B Preferred Stock.

Results of Most Recent Extended Confirmatory Phase 2 Clinical Trial

On July 23, 2020, we entered into the 2020 Services Agreement with WCT. The 2020 Services Agreement relates to services for our Phase 2 clinical study assessing the safety, tolerability and long-term efficacy of Bryostatin-1 in the treatment of moderately severe AD subjects not receiving memantine treatment. On January 22, 2022, the Company executed a change order with WCT to accelerate trial subject recruitment totaling approximately $1.4 million.  The updated total estimated budget for the services, including pass-through costs, is approximately $11.0 million. As previously disclosed, on January 22, 2020, we were granted a $2.7 million award from the NIH, which award is being used to support the 2020 Study, resulting in a current estimated net budgeted cost of the 2020 Study to us of $8.3 million. Of the $2.7 million grant, virtually all has been received as of February 22, 2022.

As of June 30, 2023, we incurred cumulative expenses of approximately $10.5 million associated with services provided by WCT and certain pass-through expenses incurred by WCT, which was offset by NIH reimbursements recognized of $2.7 million and, for the three and six months ended June 30, 2023, we incurred expenses of approximately $77,000 and $400,000 associated with services provided by WCT and certain pass-through expenses incurred by WCT.

On December 16, 2022, we issued a press release announcing that an extended confirmatory Phase 2 study of Bryostatin-1 in moderate to severe AD (Study #204) did not achieve statistical significance on the primary endpoint, which was change from baseline to Week 13 in the SIB total score assessment obtained after completion of the second seven-dose course of treatment (week 28 of trial). On March 7, 2023, we announced results of our analysis of secondary endpoints and post hoc analysis from our Phase 2 study of Bryostatin-1. In the secondary endpoint analysis, changes from baseline at Weeks 9, 20, 24, 30, and 42 in the SIB (Severe Impairment Battery) total score were not statistically significant in the total patient population, and no pre-specified secondary endpoints were met with statistical significance in the low-to-moderately severe AD patient stratum. However, nearly all pre-specified secondary endpoints in the most advanced and severe AD (MMSE: 10-14) patient population, with baseline MMSE-2 (Mini-Mental State Examination, 2nd Edition) scores of 10-14, were achieved with statistical significance (p = <0.05, 2-tailed). Data also showed statistical significance in exploratory secondary endpoints for the MMSE-2 10-14 stratum, and post hoc analysis was positive.

Open Label Dose Ranging Clinical Trial

On May 12, 2022, the Company entered into a services agreement with WCT (the “2022 Services Agreement”). The 2022 Services Agreement relates to services for a Phase 2 “open label,” dose ranging study, clinical trial assessing the safety, tolerability and efficacy of Bryostatin-1 administered via infusion in the treatment of moderately severe to severe AD subjects not receiving memantine treatment (the “2022 Study”).

Pursuant to the terms of the 2022 Services Agreement, WCT provided services to enroll approximately 12 2022 Study subjects. The first 2022 Study site was initiated during the third quarter of 2022. The total estimated budget for the services, including pass-through costs, is currently approximately $1.5 million. Either party may terminate the 2022 Services Agreement without cause upon 90 days prior written notice. Furthermore, in the event of a material breach by the other party, which breach is not cured by the breaching party, the other party may terminate the agreement upon 30 days’ prior written notice. The Company terminated the 2022 Services Agreement in December 2022.

29

The Company incurred approximately $1.6 million of cumulative expenses associated with the current 2022 Study as of June 30, 2023. Of the total $1.6 million incurred for the trial as of June 30, 2023, approximately $33,000 and $157,000 is reflected in the statement of operations, respectively and $0 for the comparable 2022 periods. As of June 30, 2023, $0 of WCT 2022 Study prepayments is included as a prepaid expense and other current assets in the Company’s balance sheet. In addition, approximately $55,000 is included in accounts payable and accrued expenses as of June 30, 2023.

Other Development Projects

To the extent resources permit, we may pursue development of selected technology platforms with indications related to the treatment of various disorders, including neurodegenerative disorders such as AD, based on our currently licensed technology and/or technologies available from third party licensors or collaborators.

Nemours Agreement

On September 5, 2018, we announced a collaboration with Nemours, a premier U.S. children’s hospital, to initiate a clinical trial in children with Fragile X. In addition to the primary objective of safety and tolerability, measurements will be made of working memory, language and other functional aspects such as anxiety, repetitive behavior, executive functioning, and social behavior. On August 5, 2021, the Company announced its memorandum of understanding with Nemours A.I. DuPont Hospital (“Nemours”) to initiate a clinical trial using Bryostatin-1, under Orphan Drug Status, to treat Fragile X. We intend to provide the Bryostatin-1 drug product candidate and obtain the IND and Nemours intends to provide the clinical site and attendant support for the trial. We and Nemours, jointly, will develop the trial protocol. We currently estimate our total trial and IND cost to be approximately $2 million. As of June 30, 2023, we have incurred cumulative expenses associated with this agreement of approximately $100,000.

We have filed for an IND with the FDA. The FDA has placed the development of the IND on clinical hold pending completion of further analytics relating to drug pharmacokinetics and pharmacodynamics. We are currently evaluating its plans to advance Fragile X development.

Cleveland Clinic

On February 23, 2022, we announced our collaboration with the Cleveland Clinic to pursue possible treatments for Multiple Sclerosis, and on July 19, 2023, we announced that we had entered into an agreement with Cleveland Clinic to conduct a Phase 1 trial of Bryostatin-1 in MS. Cleveland Clinic will manage the clinical trial’s implementation, including an IND submission to the FDA and patient enrollment. The total estimated costs associated with this collaboration are approximately $2.0 million.

Results of Operations

Comparison of the six months ended June 30, 2023 and 2022

The following table summarizes our results of operations for the six months ended June 30, 2023 and 2022:

Six Months ended

 

June 30,

Dollar

 

    

2023

    

2022

    

Change

    

% Change

 

Operating Expenses:

 

  

 

  

 

  

 

  

Research and development expenses

$

1,184,928

$

3,427,175

$

(2,242,247)

(65.4)

%

General and administrative expenses

$

3,566,726

$

3,651,748

$

(85,022)

(2.3)

%

Other income (loss), net

$

(1,054,084)

$

49,097

$

(1,103,181)

(2,246.9)

%

Net loss

$

5,805,738

$

7,029,826

$

(1,224,088)

(17.4)

%

30

Operating Expenses

Overview

Total operating expenses for the six months ended June 30, 2023 were $4,751,654 as compared to $7,078,923 for the six months ended June 30, 2022, a decrease of approximately 32.9%. The decrease in total operating expenses is due to the decrease in research and development activities and general and administrative expenses.

Research and Development Expenses

For the six months ended June 30, 2023, we incurred $1,184,928 in research and development expenses as compared to $3,427,175 for the six months ended June 30, 2022, a decrease of approximately 65.4%. These expenses were incurred primarily pursuant to developing the potential AD therapeutic product, specifically expenses relating to our ongoing Phase 2 clinical trial for AD. Of these expenses, for the six months ended June 30, 2023, $842,756 was incurred principally relating to our current confirmatory clinical trial and our Phase 2 dose ranging study and related storage of drug product, $155,868 for clinical consulting services, $10,247 of amortization of prepaid licensing fees relating to the Stanford License Agreement and Mount Sinai Agreement, $26,468 for development of alternative drug supply with Stanford University and $149,589 of non-cash stock options compensation expense; comparatively, for the six months ended June 30, 2022, $2,943,402 was incurred principally relating to our confirmatory clinical trial and related storage of drug product, $152,658 for clinical consulting services, $14,931 of amortization of prepaid licensing fees relating to the Stanford License Agreement and Mount Sinai Agreement, $23,481 for development of alternative drug supply with Stanford University and $292,703 of non-cash stock options compensation expense.

Our research and development expenses are leveling off as our current Phase 2 clinical trial for AD was materially concluded by the end of 2022 and our Phase 2 dose ranging study was discontinued. Other development expenses might increase, as our resources permit, in order to advance our potential products. We are continuing to determine how to proceed with respect to our other current development programs for Bryostatin-1.

General and Administrative Expenses

We incurred $3,566,726 and $3,651,748 of general and administrative expenses for the six months ended June 30, 2023 and 2022, respectively, a decrease of approximately 2.3%. During the six months ended June 30, 2023, $648,092 was incurred primarily for wages, bonuses, vacation pay, severance, taxes and insurance, versus $601,507 for the six months ended June 30, 2022; $493,316 was incurred for legal expenses versus $207,019 for the 2022 comparable period. The increase in legal fees for 2023 is based upon the increased fees for special stockholder vote requirements and for regulatory compliance; $472,815 was incurred for outside operations consulting services during the six months ended June 30, 2023, versus $589,454 for the comparable period in 2022. The decrease for the 2023 period is based upon a decrease in non-cash compensation paid; $74,048 was incurred for travel expenses during the six months ended June 30, 2023, versus $39,131 for the comparable period in 2022 as post-COVID travel has increased; $240,628 was incurred for investor relations services during the six months ended June 30, 2023, versus $133,569 for the comparable period in 2022, with the increase for the current period based upon engaging additional consultants to assist with Company communications; $185,209 was incurred for professional fees associated with auditing, financial, accounting and tax advisory services during the six months ended June 30, 2023, versus $109,725 for the comparable period in 2022. The increase for the current period is primary attributable to additional audit work for the November Private Placement and auditor change; $387,164 was incurred for insurance during the six months ended June 30, 2023, versus $365,544 for the comparable period in 2022; $235,846 was incurred for utilities, supplies, license fees, filing costs, rent, advertising and other during the six months ended June 30, 2023, versus $170,254 for the comparable period in 2022, with the increase for 2023 primary attributable to recognizing Delaware franchise tax quarterly; and $829,608 was recorded as non-cash stock options compensation expense during the six months ended June 30, 2023, versus $1,435,545 for the comparable period in 2022.

Other Income / Expense

We recognized a total other loss of $1,054,084 for the six months ended June 30, 2023 as compared to a total gain of $49,097 for the six months ended June 30, 2022, which consisted, for 2023, of interest income on funds deposited in interest bearing money market accounts and changes in fair value of warrant liability and derivative liability versus interest income only for 2022. The increase in interest income of $774,419 is primarily attributable to the increase in money market interest income rates and increase in cash balances. The total decrease is primarily attributable to the increase in fair value of derivative liability of $2,258,600 and the increase in fair value of warrant liability of $381,000 partially offset by the increase in interest income.

31

Net loss

We incurred losses of $5,805,738 and $7,029,826 for the six months ended June 30, 2023 and 2022, respectively. The decreased loss was primarily attributable to the decrease in net research and development expenses associated with our current Phase 2 confirmatory clinical trial and general and administrative expenses and other income.

Comparison of the three months ended June 30, 2023 and 2022

The following table summarizes our results of operations for the three months ended June 30, 2023 and 2022:

Three Months ended

 

June 30,

Dollar

 

    

2023

    

2022

    

Change

    

% Change

 

Operating Expenses:

 

 

 

 

Research and development expenses

$

307,211

$

1,941,101

$

(1,633,890)

 

(84.2)

%

General and administrative expenses

$

1,522,502

$

1,855,290

$

(332,788)

 

(17.9)

%

Other income (loss), net

$

(2,264,241)

$

44,487

$

136,372

 

306.5

%

Net loss

$

4,093,954

$

3,751,904

$

342,050

 

9.1

%

Operating Expenses

Overview

Total operating expenses for the three months ended June 30, 2023 were $1,829,713 as compared to $3,796,391 for the three months ended June 30, 2022, a decrease of approximately 51.8%. The decrease in total operating expenses is due to the decrease in research and development activities and general and administrative expenses.

Research and Development Expenses

For the three months ended June 30, 2023, we incurred $307,211 in research and development expenses as compared to $1,941,101 for the three months ended June 30, 2022, a decrease of approximately 84.2%. These expenses were incurred primarily in connection with developing the potential AD therapeutic product, specifically expenses relating to our ongoing Phase 2 clinical trial for AD. Of these expenses, for the three months ended June 30, 2023, $167,495 was incurred principally relating to our current confirmatory clinical trial and our Phase 2 dose ranging study and related storage of drug product, $74,121 for clinical consulting services, $4,986 of amortization of prepaid licensing fees relating to the Stanford License Agreement and Mount Sinai Agreement, $10,746 for development of alternative drug supply with Stanford University and $49,863 of non-cash stock options compensation expense; comparatively, for the three months ended June 30, 2022, $1,680,918 was incurred principally relating to our confirmatory clinical trial and related storage of drug product, $73,113 for clinical consulting services, $7,479 of amortization of prepaid licensing fees relating to the Stanford License Agreement and Mount Sinai Agreement, $7,938 for development of alternative drug supply with Stanford University and $35,763 of non-cash stock options compensation expense.

Our research and development expenses have significantly decreased as our current Phase 2 clinical trial for AD was materially concluded by the end of 2022 and our Phase 2 dose ranging study was discontinued. Other development expenses might increase, as our resources permit, in order to advance our potential products. We are continuing to determine how to proceed with respect to our other current development programs for Bryostatin-1.

32

General and Administrative Expenses

We incurred $1,522,502 and $1,855,290 of general and administrative expenses for the three months ended June 30, 2023 and 2022, respectively, a decrease of approximately 17.9%. During the three months ended June 30, 2023, $328,330 was incurred primarily for wages, bonuses, vacation pay, severance, taxes and insurance, versus $307,603 for the three months ended June 30, 2022; $211,635 was incurred for legal expenses versus $77,804 for the 2022 comparable period. The increase in legal fees for 2023 is based upon the prior year’s increased fees for special stockholder vote requirements and for regulatory compliance; $222,515 was incurred for outside operations consulting services during the three months ended June 30, 2023, versus $193,250 for the comparable period in 2022; $51,151 was incurred for travel expenses during the three months ended June 30, 2023, versus $24,479 for the comparable period in 2022 as post-COVID travel has increased; $55,967 was incurred for investor relations services during the three months ended June 30, 2023, versus $61,355 for the comparable period in 2022; $63,885 was incurred for professional fees associated with auditing, financial, accounting and tax advisory services during the three months ended June 30, 2023, versus $87,677 for the comparable period in 2022; $193,441 was incurred for insurance during the three months ended June 30, 2023, versus $181,236 for the comparable period in 2022; $111,025 was incurred for utilities, supplies, license fees, filing costs, rent, advertising and other during the three months ended June 30, 2023, versus $76,849 for the comparable period in 2022; and $284,553 was recorded as non-cash stock options compensation expense during the three months ended June 30, 2023, versus $845,037 for the comparable period in 2022.

Other Income / Expense

We recognized a total other loss of $2,264,241 for the three months ended June 30, 2023 as compared to a total other gain of $44,487 for the three months ended June 30, 2022, which consisted, for 2023, of interest income on funds deposited in interest bearing money market accounts and changes in fair value of warrant liability and derivative liability versus interest income only for 2022. The increase in interest income of $382,672 is primarily attributable to the increase in money market interest income rates and increase in cash balances. The total decrease is primarily attributable to the increase in fair value of warrant liability of $207,000 and increase in fair value of derivative liability of $2,484,400 partially offset by the increase in interest income.

Net loss

We incurred losses of $4,093,954 and $3,751,904 for the three months ended June 30, 2023 and 2022, respectively. The increased loss was primarily attributable to the increase in other losses mostly offset by both the decreases in net research and development expenses associated with our current Phase 2 confirmatory clinical trial and general and administrative expenses.

Financial Condition, Liquidity and Capital Resources

Cash and Working Capital

Since inception, we have incurred negative cash flows from operations. As of June 30, 2023, we had working capital of $30,643,068 as compared to working capital of $37,272,851 as of December 31, 2022. The $6,629,783 decrease in working capital was primarily attributable to approximately $5.3 million of operating expenses, preferred stock dividends of approximately $0.7 million and sources of cash of approximately $2.0 million partially offset by non-cash expenses of approximately $0.6 million and interest income of approximately $0.8 million.

We expect that our current cash and cash equivalents of approximately $32.5 million will be sufficient to support our projected operating requirements for at least the next 12 months from the date of this Quarterly Report on Form 10-Q, which would include the continuing development of Bryostatin-1, our novel drug candidate targeting the activation of PKCε, our initiation and possible development of a therapeutic for MS and other possible therapeutics.

33

We expect to require additional capital in order to initiate, pursue and complete all potential AD clinical trials and obtain regulatory approval of one or more therapeutic candidates. However, additional future funding may not be available to us on acceptable terms, or at all. If we are unable to access additional funds when needed, we may not be able to initiate, pursue and complete all planned clinical trials or continue the development of our product candidates or we could be required to delay, scale back or eliminate some or all of our development programs and operations. Any additional equity financing, if available, may not be available on favorable terms, would most likely be significantly dilutive to our current stockholders and debt financing, if available, and may involve restrictive covenants. If we are able to access funds through collaborative or licensing arrangements, we may be required to relinquish rights to some of our technologies or product candidates that we would otherwise seek to develop or commercialize on our own, on terms that are not favorable to us. Our ability to access capital when needed is not assured and, if not achieved on a timely basis, would likely materially harm our business and financial condition.

Sources and Uses of Liquidity

We expect to continue to incur expenses, resulting in losses and negative cash flows from operations, over at least the next several years as we continue to develop AD and other therapeutic products. We anticipate that this development may include clinical trials in addition to our current ongoing clinical trial and additional research and development expenditures.

Six Months Ended June 30,

    

2023

    

2022

Cash used in operating activities

$

2,935,299

$

6,009,489

Cash used in investing activities

2,707

3,029

Cash used in (provided by) financing activities

 

1,641,064

(553,150)

Net Cash Used in Operating Activities

Cash used in operating activities was $2,935,299 for the six months ended June 30, 2023, compared to $6,009,489 for the six months ended June 30, 2022. The $3,074,190 decrease primarily resulted from the decrease in net loss of approximately $1.2 million, the decrease in prepaid expenses of approximately $0.1 million and the increase in accounts payable and accrued expenses of approximately $0.7 million, and the changes in fair value of non-cash warrant and derivative liabilities totaling approximately $1.9 partially offset by an increase in non-cash stock-based compensation of approximately $0.8 million.

Net Cash Used in Investing Activities

Net cash used in investing activities was $2,707 for the six months ended June 30, 2023 compared to $3,029 for the six months ended June 30, 2022. The cash used in investing activities for the six months ended June 30, 2023 was for capital expenditures.

Net Cash Used in / Provided by Financing Activities

Net cash used in financing activities was $1,641,064 for the six months ended June 30, 2023 compared to cash provided by financing activities of $553,150 for the six months ended June 30, 2022. The net cash used in financing activities for the 2023 period was for paying dividends and redeeming part of the investment made by investors in the November Private Placement.  Funds provided by financing activities for the comparable 2022 period resulted from the exercise of investor warrants issued in 2021.

Item 3. Quantitative and Qualitative Disclosures about Market Risk

Not applicable to a smaller reporting company.

34

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

An evaluation was performed under the supervision and with the participation of our Chief Executive Officer and our Chief Financial Officer, our principal executive officer and principal financial and accounting officer, respectively, of the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) or 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of the end of the period covered by this report. Based on their evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures are not effective due to: inadequate segregation of duties consistent with control objectives in the areas over certain payroll and banking systems and user access controls; ineffective processes over period end financial disclosure and reporting including documentation of GAAP disclosure and reporting reviews supporting the financial reporting process and changes to chart of accounts; and ineffective information technology (IT) general computing controls including lack of risk and design assessments supporting IT security policies and procedures, user access, and IT controls within third party contracts. These weaknesses may affect management’s ability to determine if errors or inappropriate actions have taken place. Management is required to apply its judgment in evaluating the cost-benefit relationship of possible changes in our disclosure controls and procedures.

We previously disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, that our management, including our Chairman of the Board, principal executive officer and principal financial and accounting officer, assessed the effectiveness of our internal control over financial reporting based on the criteria for effective internal control over financial reporting established in the 2013 Internal Control— Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) and SEC guidance on conducting such assessments. Based on that evaluation, they concluded that, during the period covered by the Annual Report on Form 10-K for the fiscal year ended December 31, 2022, such internal controls and procedures were not effective to detect the inappropriate application of US generally accepted accounting principles.

Based on management’s review, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were ineffective as of June 30, 2023. Notwithstanding the material weaknesses described above, our management, including the Chief Executive Officer and Chief Financial Officer, has concluded that financial statements, and other financial information included in this Quarterly Report on Form 10-Q, fairly present in all material respects our financial condition, results of operations, and cash flows as of and for the periods presented in this Quarterly Report on Form 10-Q.

Changes in Internal Controls over Financial Reporting

There was no change in our internal controls over financial reporting that occurred during the period covered by this Quarterly Report on Form 10-Q, which has materially affected, or is reasonably likely to materially affect, our internal controls over financial reporting.

35

PART II

OTHER INFORMATION

Item 1. Legal Proceedings.

None.

Item 1A. Risk Factors.

You should carefully review and consider the information regarding certain factors that could materially affect our business, consolidated financial condition or results of operations set forth under Item 1A. Risk Factors in our 2022 Annual Report on Form 10-K. There have been no material changes from the risk factors disclosed in our 2022 Annual Report on Form 10-K. We may disclose changes to risk factors from time to time in our future filings with the SEC.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

On June 7, 2023, we issued 5,409 shares of Common Stock to Neil Cataldi in exchange for investor relations services.

The foregoing transaction did not involve any underwriters or any public offering. The sale of the above securities were deemed to be exempt from registration under the Securities Act in reliance on Section 4(a)(2) of the Securities Act (and Regulation D promulgated thereunder) or Rule 701 promulgated under Section 3(b) of the Securities Act as transactions by an issuer not involving any public offering. The recipient of the securities in the transaction represented their intentions to acquire the securities for investment only and not with a view to, or for sale in connection with, any distribution thereof, and appropriate legends were affixed to the securities issued in these transactions. The recipient received or had, through his relationships with us, adequate access to information about us.

Item 3. Defaults upon Senior Securities.

None.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

Rule 10b5-1 Trading Plans

During the fiscal quarter ended June 30, 2023, none of our directors or executive officers adopted, modified or terminated any contract, instruction or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) or any “non-Rule 10b5-1 trading arrangement.”

36

Item 6. Exhibits.

Exhibit
Number

    

 

 

 

 

10.1#

Amendment to the offer letter, dated June 16, 2023, by and between the Company and Alan J. Tuchman, M.D. (incorporated by reference from Exhibit 10.1 to the Current Report on Form 8-K filed on June 22, 2023).

31.1**

 

Certification of the President and Chief Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2**

 

Certification of the Chief Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

32.1*

 

Certification of the President and Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

32.2*

 

Certification of the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

101

 

The following financial information from this Quarterly Report on Form 10-Q for the period ended June 30, 2023, formatted in iXBRL (Inline Extensible Business Reporting Language): (i) the Condensed Statements of Operations; (ii) the Condensed Balance Sheets; (iii) the Condensed Statements of Cash Flows; and (iv) the Notes to Financial Statements, tagged as blocks of text.

104

Cover Page Interactive Data File (Embedded within the Inline XBRL document and included in Exhibit)

* The certifications attached as Exhibit 32.1 and Exhibit 32.2 that accompany this Quarterly Report on Form 10-Q are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of Synaptogenix, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of such Form 10-Q), irrespective of any general incorporation language contained in such filing.

**Filed herewith

# Management contract or compensatory plan or arrangement.

37

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

Synaptogenix, Inc.

 

 

Date: August 14, 2023

By:

/s/ Alan J. Tuchman, M.D.

 

 

Alan J. Tuchman, M.D.

 

 

Chief Executive Officer

 

 

(principal executive officer)

 

 

Date: August 14, 2023

By:

/s/ Robert Weinstein

 

 

Robert Weinstein

 

 

Chief Financial Officer, Executive Vice President, Secretary and Treasurer

38

Exhibit 31.1

CERTIFICATION

OF

ALAN J. TUCHMAN, M.D.

CHIEF EXECUTIVE OFFICER

OF

SYNAPTOGENIX, INC.

I, Alan J. Tuchman, M.D., Chief Executive Officer of Synaptogenix, Inc., certify that:

1. I have reviewed this quarterly report on Form 10-Q of Synaptogenix, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors:

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: August 14, 2023

/s/ Alan J. Tuchman, M.D.

Alan J. Tuchman, M.D.

Chief Executive Officer

(principal executive officer)


Exhibit 31.2

CERTIFICATION

OF

ROBERT WEINSTEIN

CHIEF FINANCIAL OFFICER

OF

SYNAPTOGENIX, INC.

I, Robert Weinstein, Chief Financial Officer of Synaptogenix, Inc., certify that:

1. I have reviewed this quarterly report on Form 10-Q of Synaptogenix, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant's board of directors:

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: August 14, 2023

/s/ Robert Weinstein

Robert Weinstein

Chief Financial Officer, Executive Vice President, Secretary and Treasurer

(principal financial officer and principal accounting officer)


Exhibit 32.1

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Synaptogenix, Inc. (the “Company”) on Form 10-Q for the period ending June 30, 2023, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Alan J. Tuchman, M.D., Chief Executive Officer of the Company, state and certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: August 14, 2023

/s/ Alan J. Tuchman, M.D.

Alan J. Tuchman, M.D.

Chief Executive Officer

(principal executive officer)


Exhibit 32.2

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Synaptogenix, Inc. (the “Company”) on Form 10-Q for the period ending June 30, 2023, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Robert Weinstein, Chief Financial Officer of the Company, state and certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: August 14, 2023

/s/ Robert Weinstein

Robert Weinstein

Chief Financial Officer, Executive Vice President, Secretary and Treasurer

(principal financial officer and principal accounting officer)

(principal financial officer)


v3.23.2
Document and Entity Information - shares
6 Months Ended
Jun. 30, 2023
Aug. 10, 2023
Document and Entity Information    
Document Type 10-Q  
Document Quarterly Report true  
Document Period End Date Jun. 30, 2023  
Document Transition Report false  
Entity File Number 001-40458  
Entity Registrant Name Synaptogenix, Inc.  
Entity Incorporation, State or Country Code DE  
Entity Tax Identification Number 46-1585656  
Entity Address, Address Line One 1185 Avenue of the Americas  
Entity Address, Address Line Two 3rd Floor  
Entity Address, City or Town New York  
Entity Address, State or Province NY  
Entity Address, Postal Zip Code 10036  
City Area Code 973  
Local Phone Number 242-0005  
Title of 12(b) Security Common Stock, $0.0001 par value per share  
Trading Symbol SNPX  
Security Exchange Name NASDAQ  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Non-accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company true  
Entity Ex Transition Period false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   10,164,529
Entity Central Index Key 0001571934  
Current Fiscal Year End Date --12-31  
Document Fiscal Year Focus 2023  
Document Fiscal Period Focus Q2  
Amendment Flag false  
v3.23.2
Condensed Balance Sheets - USD ($)
Jun. 30, 2023
Dec. 31, 2022
CURRENT ASSETS    
Cash and cash equivalents $ 32,899,410 $ 37,478,480
Prepaid Clinical trial expenses 130,548 367,714
Prepaid expenses and other current assets 385,769 739,467
TOTAL CURRENT ASSETS 33,415,727 38,585,661
Fixed assets, net of accumulated depreciation 21,438 22,145
TOTAL ASSETS 33,437,165 38,607,806
CURRENT LIABILITIES    
Accounts payable 439,147 660,206
Accrued expenses 68,137 536,714
Dividend payable   115,890
Accrued Series B Convertible Preferred payments payable 2,265,375  
TOTAL CURRENT LIABILITIES 2,772,659 1,312,810
Warrant liability 1,129,000 1,510,000
Derivative liability 2,628,000 370,300
TOTAL LIABILITIES 6,529,659 3,193,110
Commitments and contingencies
Series B Convertible redeemable preferred stock, $.0001 par value and $1,000 face value, 1,000,000 shares authorized; 14,000 and 15,000 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively. Liquidation preference of $14,000,000 plus dividends accrued at 7% per annum of $165,375 as of June 30, 2023. 2,077,379 2,721,723
STOCKHOLDERS' EQUITY    
Common stock - 150,000,000 shares authorized, $0.0001 par value; 7,365,280 shares issued and outstanding as of June 30, 2023 and 7,267,032 shares issued and outstanding as of December 31, 2022. 738 728
Additional paid-in capital 56,849,293 52,523,762
Accumulated deficit (32,019,904) (19,831,517)
TOTAL STOCKHOLDERS' EQUITY 24,830,127 32,692,973
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 33,437,165 $ 38,607,806
v3.23.2
Condensed Balance Sheets (Parenthetical) - USD ($)
6 Months Ended 12 Months Ended
Jun. 30, 2023
Dec. 31, 2022
Condensed Balance Sheets    
Series B Convertible redeemable preferred stock, par value per share $ 0.0001 $ 0.0001
Series B Convertible redeemable preferred stock, face value per share $ 1,000 $ 1,000
Series B Convertible redeemable preferred stock, Shares authorized 1,000,000 1,000,000
Series B Convertible redeemable preferred stock, Shares issued 14,000 15,000
Series B Convertible redeemable preferred stock, Shares outstanding 14,000 15,000
Series B Convertible redeemable preferred stock, Liquidation preference value $ 14,000,000  
Series B Convertible redeemable preferred stock, Liquidation preference, percentage of accrued dividends 7.00%  
Series B Convertible redeemable preferred stock, Liquidation preference, amount of accrued dividends $ 165,375  
Common stock, shares authorized 150,000,000 150,000,000
Common stock, par value $ 0.0001 $ 0.0001
Common stock, shares issued 7,365,280 7,267,032
Common stock, shares outstanding 7,365,280 7,267,032
v3.23.2
Condensed Statements of Operations - USD ($)
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
OPERATING EXPENSES:        
Research and development $ 307,211 $ 1,941,101 $ 1,184,928 $ 3,427,175
General and administrative 1,522,502 1,855,290 3,566,726 3,651,748
TOTAL OPERATING EXPENSES 1,829,713 3,796,391 4,751,654 7,078,923
OTHER INCOME (EXPENSE):        
Interest income 427,159 44,487 823,516 49,097
Change in fair value of warrant liability (207,000)   381,000  
Change in fair value of derivative liability (2,484,400) 0 (2,258,600) 0
TOTAL OTHER INCOME (EXPENSE) (2,264,241) 44,487 (1,054,084) 49,097
Net loss before income taxes 4,093,954 3,751,904 5,805,738 7,029,826
Net loss 4,093,954 3,751,904 5,805,738 7,029,826
Preferred Stock dividends 423,575   689,649  
Deemed dividend - preferred stock extinguishment 5,693,000   5,693,000  
Net loss attributable to common stockholders $ 10,210,529 $ 3,751,904 $ 12,188,387 $ 7,029,826
PER SHARE DATA:        
Basic loss per common share $ 1.39 $ 0.54 $ 1.66 $ 1.01
Diluted loss per common share $ 1.39 $ 0.54 $ 1.66 $ 1.01
Basic weighted average common shares outstanding 7,361,300 6,959,400 7,356,600 6,949,400
Diluted weighted average common shares outstanding 7,361,300 6,959,400 7,356,600 6,949,400
v3.23.2
Condensed Statements of Changes in Stockholders' Equity - USD ($)
Common Stock
Preferred Stock
Additional Paid-In Capital
Accumulated Deficit
Total
Balance, Beginning at Dec. 31, 2021 $ 0 $ 674 $ 47,670,744 $ (14,141,670) $ 33,529,748
Balance, Beginning (in shares) at Dec. 31, 2021 0 6,730,180      
Stock based compensation $ 0 $ 0 1,728,248 0 1,728,248
Issuance of warrants for consulting fees     71,603   71,603
Issuance of common stock for consulting fees   $ 1 100,349   100,350
Issuance of common stock for consulting fees (in shares)   15,146      
Exercise of common stock warrants   $ 7 553,143   553,150
Exercise of common stock warrants (in shares)   65,000      
Net loss       (7,029,826) (7,029,826)
Balance, Ending at Jun. 30, 2022 $ 682 $ 682 50,124,087 (21,171,496) 28,953,273
Balance, Ending (in shares) at Jun. 30, 2022 6,810,326 6,810,326      
Balance, Beginning at Mar. 31, 2022 $ 682 $ 0 49,102,898 (17,419,592) 31,683,988
Balance, Beginning (in shares) at Mar. 31, 2022 6,809,647 0      
Stock based compensation $ 0 $ 0 1,016,690 0 1,016,690
Issuance of common stock for consulting fees     4,499   4,499
Issuance of common stock for consulting fees (in shares) 679        
Net loss       (3,751,904) (3,751,904)
Balance, Ending at Jun. 30, 2022 $ 682 $ 682 50,124,087 (21,171,496) 28,953,273
Balance, Ending (in shares) at Jun. 30, 2022 6,810,326 6,810,326      
Balance, Beginning at Dec. 31, 2022 $ 728 $ 2,721,723 52,523,762 (19,831,517) 32,692,973
Balance, Beginning (in shares) at Dec. 31, 2022 7,267,032 15,000      
Beginning balance at Dec. 31, 2022         $ 2,721,723
Beginning balance (in shares) at Dec. 31, 2022         15,000
Stock based compensation $ 0 $ 0 979,197 0 $ 979,197
Issuance of common stock for consulting fees $ 10   108,990   109,000
Issuance of common stock for consulting fees (in shares) 98,248        
Accrued preferred stock dividends       (689,649) (689,649)
Preferred stock dividends paid   (689,649)     (689,649)
Reclassification of accrued dividends upon probable redemption of preferred stock   165,375      
Deemed dividend - preferred stock extinguishment   689,649 5,693,000 (5,693,000)  
Preferred stock redemptions   $ (1,000,000)      
Preferred stock redemptions (in shares)   (1,000)      
Accrual of preferred stock and dividend redemption   $ (2,265,375)     2,265,375
Preferred stock accretion   2,455,656 (2,455,656)   (2,455,656)
Net loss       (5,805,738) (5,805,738)
Balance, Ending at Jun. 30, 2023 $ 738 $ 2,077,379 56,849,293 (32,019,904) 24,830,127
Balance, Ending (in shares) at Jun. 30, 2023 7,365,280 14,000      
Beginning balance at Mar. 31, 2023 $ 737 $ 2,721,723 53,273,034 (21,809,375) 31,464,396
Beginning balance (in shares) at Mar. 31, 2023 7,359,871 15,000      
Stock based compensation $ 0 $ 0 334,416 0 334,416
Issuance of common stock for consulting fees $ 1   4,499   4,500
Issuance of common stock for consulting fees (in shares) 5,409        
Accrued preferred stock dividends       (423,575) (423,575)
Preferred stock dividends paid   (423,575)     (423,575)
Reclassification of accrued dividends upon probable redemption of preferred stock   165,375      
Deemed dividend - preferred stock extinguishment   423,575 5,693,000 (5,693,000)  
Preferred stock redemptions   $ (1,000,000)      
Preferred stock redemptions (in shares)   (1,000)      
Accrual of preferred stock and dividend redemption   $ (2,265,375)      
Preferred stock accretion   2,455,656 (2,455,656)   (2,455,656)
Net loss       (4,093,954) (4,093,954)
Balance, Ending at Jun. 30, 2023 $ 738 $ 2,077,379 $ 56,849,293 $ (32,019,904) $ 24,830,127
Balance, Ending (in shares) at Jun. 30, 2023 7,365,280 14,000      
v3.23.2
Condensed Statements of Cash Flows - USD ($)
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2023
Jun. 30, 2022
CASH FLOW USED IN OPERATING ACTIVITIES      
Net loss $ (4,093,954) $ (5,805,738) $ (7,029,826)
Adjustments to reconcile net loss to net cash used by operating activities      
Stock based compensation   979,197 1,728,248
Change in fair value of warrant liability 207,000 (381,000)  
Change in fair value of derivative liability   2,258,600  
Consulting services paid by issuance of common stock   109,000 100,349
Consulting services paid by issuance of common stock warrants     71,603
Depreciation expense   3,414 2,697
Change in assets and liabilities:      
Decrease in prepaid expenses   590,864 486,372
Decrease in accounts payable   (221,059) (1,015,640)
Decrease in accrued expenses   (468,577) (353,292)
Total adjustments   2,870,439 1,020,337
Net Cash Used in Operating Activities   (2,935,299) (6,009,489)
CASH FLOWS USED IN INVESTING ACTIVITIES      
Purchase of fixed assets   (2,707) (3,029)
Net Cash Used in Investing Activities   (2,707) (3,029)
CASH FLOWS FROM FINANCING ACTIVITIES      
Proceeds from exercise of investor warrants     553,150
Redemption of Series B Convertible Preferred Stock   (1,000,000)  
Dividends on Series B Convertible Preferred Stock   (641,064)  
Net Cash Provided by Financing Activities   (1,641,064) 553,150
NET DECREASE IN CASH AND EQUIVALENTS   (4,579,070) (5,459,368)
CASH AND EQUIVALENTS AT BEGINNING OF PERIOD   37,478,480 34,213,989
CASH AND EQUIVALENTS AT END OF PERIOD 32,899,410 32,899,410 28,754,621
DISCLOSURES OF NON-CASH FINANCING ACTIVITIES:      
Accrual of Series B Convertible Preferred Stock Dividends   689,649 $ 115,890
Accretion of Series B Convertible Preferred Stock to redemption value $ 2,455,656 2,455,656  
Deemed dividend for Series B Convertible Preferred Stock modification   5,693,000  
Accrual of Series B Convertible Preferred Stock and Dividend Redemption   $ 2,265,375  
v3.23.2
Organization, Business, Risks and Uncertainties:
6 Months Ended
Jun. 30, 2023
Organization, Business, Risks and Uncertainties  
Organization, Business, Risks and Uncertainties:

Note 1 – Organization, Business, Risks and Uncertainties:

Organization and Business

On May 17, 2020, Neurotrope, Inc. (“Neurotrope” or “the Parent”) announced plans for the complete legal and structural separation of its wholly owned subsidiary, Neurotrope Bioscience, Inc., from Neurotrope (the “Spin-Off”). Under the Separation and Distribution Agreement, Neurotrope planned to distribute all of its equity interest in this wholly owned subsidiary to Neurotrope’s stockholders. Following the Spin-Off, Neurotrope does not own any equity interest in the Company, and the Company operates independently from Neurotrope. On December 7, 2020, the Company became an independent company, Synaptogenix, Inc., a Delaware corporation (formerly known as Neurotrope Bioscience, Inc.) (the “Company” or “Synaptogenix”) when the Company filed an amended and restated certificate of incorporation which, among other things, changed its name to Synaptogenix, Inc. The Company’s shares of common stock, par value $0.0001 per share (the “Common Stock”), are listed on The Nasdaq Capital Market under the symbol “SNPX.”

Neurotrope Bioscience, Inc. was incorporated in Delaware on October 31, 2012 to advance new therapeutic and diagnostic technologies in the field of neurodegenerative disease, primarily Alzheimer’s disease (“AD”). The Company is collaborating with Cognitive Research Enterprises, Inc. (formerly known as the Blanchette Rockefeller Neurosciences Institute, or BRNI) (“CRE”), a related party, in this process. The exclusive rights to certain technology were licensed by CRE to the Company on February 28, 2013 (see Note 4 - Related Party Transactions).

In connection with the separation from Neurotrope, the Company entered into a Separation and Distribution Agreement and several other ancillary agreements. These agreements govern the relationship between the parties after the separation and allocate between the parties’ various assets, liabilities, rights and obligations following the separation, including employee benefits, intellectual property, information technology, insurance and tax-related liabilities.

On December 16, 2022, the Company issued a press release announcing that an extended confirmatory Phase 2 study of Bryostatin-1 in moderate to severe AD (Study #204) did not achieve statistical significance on the primary endpoint, which was changed from baseline to Week 13 in the Severe Impairment Battery (“SIB”) total score assessment obtained after completion of the second seven-dose course of treatment (week 28 of trial). On March 7, 2023, the Company announced results of its analysis of secondary endpoints and post hoc analysis from our Phase 2 study of Bryostatin-1. In the secondary endpoint analysis, changes from baseline at Weeks 9, 20, 24, 30, and 42 in the SIB (Severe Impairment Battery) total score were not statistically significant in the total patient population, and no pre-specified secondary endpoints were met with statistical significance in the low-to-moderately severe AD patient stratum. However, nearly all pre-specified secondary endpoints in the most advanced and severe AD (Mini Mental State Exam 2 (“MMSE”) (baseline scores: 10-14) patient population, with baseline MMSE-2 (Mini-Mental State Examination, 2nd Edition) scores of 10-14, were achieved with statistical significance (p = <0.05, 2-tailed). Data also showed statistical significance in exploratory secondary endpoints for the MMSE-2 10-14 stratum, and post hoc analysis was positive.

On April 24, 2023, the Company received a written notice from the Listing Qualifications Department of the Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that for the preceding 30 consecutive business days, the Company’s common stock did not maintain a minimum closing bid price of $1.00 per share as required by Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has a grace period of 180 calendar days, or until October 23, 2023, to regain compliance with Nasdaq Listing Rule 5550(a)(2). Compliance can be achieved automatically and without further action if the closing bid price of the Company’s stock is at or above $1.00 for a minimum of 10 consecutive business days at any time during the 180-day compliance period, in which case Nasdaq will notify the Company of its compliance and the matter will be closed. If, however, the Company does not achieve compliance with the Minimum Bid Price Requirement by October 23, 2023, the Company may be eligible for additional time to comply.

Liquidity Uncertainties

As of June 30, 2023, the Company had approximately $32.9 million in cash and cash equivalents as compared to $37.5 million at December 31, 2022. The Company expects that its current cash and cash equivalents, approximately $32.5 million as of the date of this Quarterly Report on Form 10-Q, will be sufficient to support its projected operating requirements and financial commitments for at least the next 12 months from this date. The operating requirements include the current development plans for Bryostatin-1, our novel drug candidate targeting the activation of Protein Kinase C Epsilon and other development projects. The financial commitments include the potential redemption of the Series B Convertible Preferred Stock for cash.

The Company expects to need additional capital in order to initiate and pursue potential additional development projects, including the continuing development beyond the ongoing Phase 2 trial of Bryostatin-1. Any additional equity financing, if available, may not be on favorable terms and would likely be significantly dilutive to the Company’s current stockholders, and debt financing, if available, may involve restrictive covenants. If the Company is able to access funds through collaborative or licensing arrangements, it may be required to relinquish rights to some of its technologies or product candidates that the Company would otherwise seek to develop or commercialize on its own, on terms that are not favorable to the Company. The Company’s ability to access capital when needed is not assured and, if not achieved on a timely basis, will likely have a materially adverse effect on our business, financial condition and results of operations.

Other Risks and Uncertainties

 

The Company operates in an industry that is subject to rapid technological change, intense competition, and significant government regulation. The Company’s operations are subject to significant risk and uncertainties including financial, operational, technological and regulatory. Such factors include, but are not necessarily limited to, the results of clinical testing and trial activities, the ability to obtain regulatory approval, the limited supply of raw materials, the ability to obtain favorable licensing, manufacturing or other agreements, including risk associated with our CRE licensing agreement, and the ability to raise capital to achieve strategic objectives.

CRE has entered into a material transfer agreement with the National Cancer Institute of the National Institutes of Health (“NCI”), pursuant to which the NCI has agreed to supply bryostatin required for the Company’s pre-clinical research and clinical trials. This agreement does not provide for a sufficient amount of bryostatin to support the completion of all of the clinical trials that the Company is required to conduct in order to seek U.S. Food and Drug Administration (“FDA”) approval. Therefore, CRE or the Company would have to enter into one or more subsequent agreements with the NCI for the supply of additional amounts of bryostatin. If CRE or the Company were unable to secure such additional agreements, or if the NCI otherwise discontinues the supply, the Company would have to either secure another source of bryostatin or discontinue its efforts to develop and commercialize Bryostatin-1 for the treatment of AD. In June 2020, the Company entered into a supply agreement (the “Supply Agreement”) with BryoLogyx Inc. (“BryoLogyx”), pursuant to which BryoLogyx agreed to be the Company’s exclusive supplier of synthetic bryostatin. Pursuant to the terms of the Supply Agreement, the Company received its initial order of one gram of synthetic bryostatin. See Note 3.

The Company also faces the ongoing risk that the coronavirus pandemic may slow, for an unforeseeable period, the conduct of the Company’s future trials. In order to prioritize patient health and that of the investigators at clinical trial sites, we will monitor enrollment of new patients in our future clinical trials. In addition, some patients may be unwilling to enroll in our trials or be unable to comply with clinical trial protocols if quarantines or travel restrictions impede patient movement or interrupt healthcare services. These and other factors outside of our control could delay our ability to conduct clinical trials or release clinical trial results. In addition, the effects of a pandemic resurgence may also increase non-trial costs such as insurance premiums, increase the demand for and cost of capital, increase loss of work time from key personnel, and negatively impact our key clinical trial vendors and suppliers.

v3.23.2
Summary of Significant Accounting Policies:
6 Months Ended
Jun. 30, 2023
Summary of Significant Accounting Policies  
Summary of Significant Accounting Policies:

Note 2 – Summary of Significant Accounting Policies:

Basis of Presentation:

The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial reporting and with the instructions to Form 10-Q and Article 10 of Regulation S-X. In the opinion of management, the unaudited condensed financial statements included herein contain all adjustments necessary to present fairly the Company’s financial position and the results of its operations and cash flows for the interim periods presented. Such adjustments are of a normal recurring nature. The results of operations for the three and six months ended June 30, 2023 may not be indicative of results for the full year. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and the notes to those statements for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 21, 2023.

Use of Estimates:

The preparation of financial statements in conformity with GAAP requires management to make significant estimates that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Management evaluates its estimates on an ongoing basis using historical experience and other factors, including the general economic environment and actions it may take in the future. The Company adjusts such estimates when facts and circumstances dictate. However, these estimates may involve significant uncertainties and judgments and cannot be determined with precision. In addition, these estimates are based on management’s best judgment at a point in time and as such these estimates may ultimately differ from actual results.

Comprehensive Income (Loss)

The Company follows FASB ASC 220 in reporting comprehensive income (loss). Comprehensive income (loss) is a more inclusive financial reporting methodology that includes disclosure of certain financial information that historically has not been recognized in the calculation of net income (loss). Since the Company has no items of other comprehensive income (loss), comprehensive loss is equal to net loss for all periods presented.

Net Earnings or Loss per Share:

Net earnings or loss per share is computed by dividing net income or loss by the weighted-average number of shares of common stock outstanding during the period, excluding shares subject to redemption or forfeiture. The Company presents basic and diluted net earnings or loss per share. Diluted net earnings or loss per share reflect the actual weighted average of shares of common stock issued and outstanding during the period, adjusted for potentially dilutive securities outstanding. Potentially dilutive securities are excluded from the computation of the diluted net earnings or loss per share if their inclusion would be anti-dilutive.

As all potentially dilutive securities are anti-dilutive as of June 30, 2023 and 2022, diluted net loss per share is the same as basic net loss per share for the three and six months ended June 30, 2023 and 2022.

The weighted average dilutive securities that have been excluded from the calculation of diluted net loss per share for the three and six months ended June 30, 2023 and 2022 respectively, because to do so would be anti-dilutive (in Common Stock equivalents), are as follows:

For the Three Months Ended

For the Six Months Ended

    

June 30,

 

June 30,

2023

2022

2023

2022

Common Stock Options

 

741,850

 

130,000

703,183

128,428

Restricted Stock Units

 

 

495,000

495,000

Convertible Preferred Stock

17,876,707

17,876,707

Common Stock Warrants

 

7,179,919

 

5,487,927

7,179,919

5,855,262

Total

 

25,798,476

 

6,112,927

25,759,809

6,478,690

Cash and Cash Equivalents and Concentration of Credit Risk:

The Company considers all highly liquid cash investments with an original maturity of three months or less when purchased to be cash equivalents. At June 30, 2023, the Company’s cash balances that exceed the current insured amounts under the Federal Deposit Insurance Corporation (“FDIC”) were approximately $2.2 million. In addition, approximately $30.7 million included in cash and cash equivalents were invested in a money market fund, which is not insured under the FDIC.

Fair Value of Financial Instruments:

The carrying amounts reflected in the balance sheets for payables approximate fair value due to the short maturities of these instruments. The carrying amounts for warrant liability and derivative liability approximate fair value based on level 3 of the fair value hierarchy.

Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy:

Level 1 — Quoted prices in active markets for identical assets or liabilities.

Level 2 — Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable markets.

Level 3 — Unobservable inputs which are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.

Fixed Assets and Leases:

The Company has two leases, one of which has a term of two years during the respective reporting periods. The Company has deemed the two year lease immaterial and has not recorded it as an obligation on the balance sheet nor a right-of-use asset.  The total future expense relating to this lease is approximately $50,000 per year.

Fixed assets are stated at cost less accumulated depreciation. Depreciation is computed on a straight line basis over the estimated useful life of the asset, which is deemed to be between three and ten years.

Research and Development Costs:

All research and development costs, including costs to maintain or expand the Company’s patent portfolio licensed from CRE are expensed when incurred. Non-refundable advance payments for research and development are capitalized because the right to receive those services represents an economic benefit. Such capitalized advances will be expensed when the services occur and the economic benefit is realized. There were no capitalized research and development services, other than non-refundable advance payments as mentioned below for Worldwide Clinical Trials, Inc. (“WCT”), at June 30, 2023 and December 31, 2022.

Income Taxes:

The Company accounts for income taxes using the asset and liability approach which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and amounts reportable for income tax purposes under the “Separate return method.” Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more-likely-than-not that some portion or all of the deferred tax assets will not be realized.

The Company applies the provisions for accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold and measurement process for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The Company has determined that there are no significant uncertain tax positions requiring recognition in the accompanying financial statements. The tax period that is subject to examination by major tax jurisdictions is generally three years from the date of filing.

The Company had federal and state net operating loss carryforwards for income tax purposes of approximately $93.4 million for the period from October 31, 2012 (inception) through June 30, 2023. The net operating loss carryforwards resulted in Federal and state deferred tax asset of approximately $27.4 million at June 30, 2023. Income tax effects of share-based payments are recognized in the financial statements for those awards that will normally result in tax deductions under existing tax law. However, the deferred tax asset is offset by a full valuation allowance.

The Company may be subject to significant U.S. federal income tax-related liabilities with respect to the Spin-Off if there is a determination that the Spin-Off is taxable for U.S. federal income tax purposes. In connection with the Spin-Off, the Company believes that, among other things, the Spin-Off should qualify as a tax-free transaction for U.S. federal income tax purposes under Section 355 and Section 368(a)(1)(D) of the Internal Revenue Code of 1986 (the “Code”). If the conclusions of the tax opinions are not correct, or if the Spin-Off is otherwise ultimately determined to be a taxable transaction, the Company would be liable for U.S. federal income tax related liabilities. Pursuant to the Separation and Distribution Agreement and the Tax Matters Agreement, Neurotrope agreed to indemnify Synaptogenix for certain liabilities, and Synaptogenix agreed to indemnify Neurotrope for certain liabilities, in each case for uncapped amounts. Indemnities that Synaptogenix may be required to provide Neurotrope are not subject to any cap, may be significant and could negatively impact Synaptogenix’s business, particularly with respect to indemnities provided in the Tax Matters Agreement. Third parties could also seek to hold Synaptogenix responsible for any of the liabilities that Neurotrope has agreed to retain. Further, the indemnity from Neurotrope may not be sufficient to protect Synaptogenix against the full amount of such liabilities, and Neurotrope may not be able to fully satisfy its indemnification obligations. Moreover, even if Synaptogenix ultimately succeeds in recovering from Neurotrope any amounts for which Synaptogenix is held liable, Synaptogenix may be temporarily required to bear these losses. At June 30, 2023 and as of the date of financial statement issuance date, the Company does not have any indemnification liabilities.

Under Section 382 of the Code, as amended, changes in the Company’s ownership may limit the amount of its net operating loss carryforwards that could be utilized annually to offset future taxable income, if any. This limitation would generally apply in the event of a cumulative change in ownership of the Company of more than 50% within a three-year period. In addition, the significant historical operating losses incurred by the Company may limit the amount of its net operating loss carryforwards that could be utilized annually to offset future taxable income, if any. The Company believes that operating loss carryforwards are limited under Section 382 limitations although Section 382 studies have not been conducted to determine the actual limitations.

Expense Reimbursement for Grant Award:

The Company reduces its research and development expenses by funding received or receivable from an NIH grant during the period that the expenses are incurred. The Company recognized grant related expense reductions during the six months ended June 30, 2023 of $0 and approximately $100,000 for the three and six months ended June 30, 2022. See Note 5, “Other Commitments – Clinical Trial Services Agreements.”

Of the total $2.7 million available from the NIH grant, the Company has received the maximum reimbursements under the grant as of June 30, 2023.

Recent Accounting Pronouncements:

In August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2020-06, which reduces the number of accounting models for convertible instruments, amends diluted earnings per share calculations for convertible instruments and allows more contracts to qualify for equity classification. ASU 2020-06 will be effective for interim and annual periods beginning after December 15, 2021. The Company has adopted ASU 2020-06 as of January 1, 2022.

In June 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). This standard establishes an impairment model (known as the current expected credit loss (“CECL”) model) that is based on expected losses rather than incurred losses. Under the new guidance, an entity recognizes as an allowance its estimate of expected credit losses, which is intended to result in a timelier recognition of losses. Under the CECL model, entities will estimate credit losses over the entire contractual term of the instrument (considering estimated prepayments, but not expected extensions or modifications) from the date of initial recognition of the financial instrument. Measurement of expected credit losses are to be based on relevant forecasts that affect collectability. The scope of financial assets within the CECL methodology is broad and includes trade receivables from certain revenue transactions and certain off-balance sheet credit exposures. Different components of the guidance require modified retrospective or prospective adoption.

In November 2018, the FASB issued ASU No. 2018-19, Codification Improvements to Topic 326, Financial Instruments-Credit Losses. ASU 2018-19 clarifies that receivables arising from operating leases are not within the scope of the credit losses standard. Instead, entities would need to apply other U.S. GAAP, namely Topic 842 (Leases), to account for changes in the collectability assessment for operating leases. Other than operating lease receivables, Partnership trade receivables include receivables from finance leases and equipment sales. Under Topic 606 (Revenue from Contracts with Customers), revenue is recognized when, among other criteria, it is probable that the entity will collect the consideration to which it is entitled for goods or services transferred to a customer. At the point that finance lease receivables are recorded, they become subject to the CECL model and estimates of expected credit losses over their contractual life will be required to be recorded at inception based on historical information, current conditions, and reasonable and supportable forecasts. Trade receivables derived from equipment sales are of short duration and there is not a material difference between incurred losses and expected losses.

In April 2019, the FASB issued ASU 2019-04, Codification Improvements to Topic 326, Financial Instruments-Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments, which amends and clarifies several provisions of Topic 326. In May 2019, the FASB issued ASU 2019-05, Financial Instruments-Credit Losses (Topic 326): Targeted Transition Relief, which amends Topic 326 to allow the fair value option to be elected for certain financial instruments upon adoption. ASU 2019-10 extended the effective date of ASU 2016-13 until December 15, 2022. The Company adopted this new guidance, including the subsequent updates to Topic 326, on January 1, 2023 and the adoption did not have a material impact on the Company’s financial statements and related disclosures.

v3.23.2
Collaborative Agreements and Commitments
6 Months Ended
Jun. 30, 2023
Collaborative Agreements and Commitments  
Collaborative Agreements and Commitments

Note 3– Collaborative Agreements and Commitments:

Stanford License Agreements

On May 12, 2014, the Company entered into a license agreement (the “Stanford Agreement”) with The Board of Trustees of The Leland Stanford Junior University (“Stanford”), pursuant to which Stanford has granted to the Company a revenue-bearing, world-wide right and exclusive license, with the right to grant sublicenses (on certain conditions), under certain patent rights and related technology for the use of bryostatin structural derivatives, known as “bryologs,” for use in the treatment of central nervous system disorders, lysosomal storage diseases, stroke, cardio protection and traumatic brain injury, for the life of the licensed patents. The Company is required to use commercially reasonable efforts to develop, manufacture and sell products (“Licensed Products”) in the Licensed Field of Use (as defined in the Stanford Agreement) during the term of the licensing agreement which expires upon the termination of the last valid claim of any licensed patent under this agreement. In addition, the Company must meet specific product development milestones, and upon meeting such milestones, make specific milestone payments to Stanford. The Company must also pay Stanford royalties of 3% of net sales, if any, of Licensed Products (as defined in the Stanford Agreement) and milestone payments of up to $3.7 million dependent upon stage of product development. As of June 30, 2023, no royalties nor milestone payments have been required.

On January 19, 2017, the Company entered into a second license agreement with Stanford, pursuant to which Stanford has granted to the Company a revenue-bearing, world-wide right and exclusive license, with the right to grant sublicenses (on certain conditions), under certain patent rights and related technology for the use of “Bryostatin Compounds and Methods of Preparing the Same,” or synthesized bryostatin, for use in the treatment of neurological diseases, cognitive dysfunction and psychiatric disorders, for the life of the licensed patents. The Company paid Stanford $70,000 upon executing the license and is obligated to pay an additional $10,000 annually as a license maintenance fee. In addition, based upon certain milestones that include product development and commercialization, the Company will be obligated to pay up to an additional $2.1 million and between 1.5% and 4.5% royalty payments on certain revenues generated by the Company relating to the licensed technology. On November 9, 2021, the Company revised the existing licensing agreement with Stanford. The revisions extended all the required future product development and commercialization milestones. The Company is currently in full compliance with the revised agreement and is moving forward on its commitments. As of June 30, 2023, no royalties nor milestone payments have been earned or made.

The Company has advanced the development of synthetic bryostatin by demonstrating the equivalence of the synthetic to the natural bryostatin product. The estimated cost to initiate and produce sufficient quantities of the synthetic bryostatin drug product is approximately $1.5 million. The Company is evaluating production alternatives at this time.

Mt. Sinai License Agreement

On July 14, 2014, the Company entered into an Exclusive License Agreement (the “Mount Sinai Agreement”) with the Icahn School of Medicine at Mount Sinai (“Mount Sinai”). Pursuant to the Mount Sinai Agreement, Mount Sinai granted the Company (a) a revenue-bearing, world-wide right and exclusive license, with the right to grant sublicenses (on certain conditions), under Mount Sinai’s interest in certain joint patents held by the Company and Mount Sinai (the “Joint Patents”) as well as in certain results and data (the “Data Package”) and (b) a non-exclusive license, with the right to grant sublicenses on certain conditions, to certain technical information, both relating to the diagnostic, prophylactic or therapeutic use for treating diseases or disorders in humans relying on activation of Protein Kinase C Epsilon (“PKC ε”), which includes Niemann-Pick Disease (the “Mount Sinai Field of Use”). The Mount Sinai Agreement allows the Company to research, discover, develop, make, have made, use, have used, import, lease, sell, have sold and offer certain products, processes or methods that are covered by valid claims of Mount Sinai’s interest in the Joint Patents or an Orphan Drug Designation Application covering the Data Package (“Mount Sinai Licensed Products”) in the Mount Sinai Field of Use (as such terms are defined in the Mount Sinai Agreement).

The Company is required to pay Mt. Sinai milestone payments of $2.0 million upon approval of a new drug application (“NDA”) in the United States and an additional $1.5 million for an NDA approval in the European Union or Japan. In addition, the Company is required to pay Mt. Sinai royalties on net sales of licensed product of 2.0% for up to $250 million of net sales and 3.0% of net sales over $250 million. Since inception, the Company has paid Mt. Sinai approximately $200,000 consisting of licensing fees of $125,000 plus development costs and patent fees of approximately $75,000. As of June 30, 2023, no royalties nor milestone payments have been required.

Agreements with BryoLogyx

On June 9, 2020, the Company entered into a supply agreement (the “Supply Agreement”) with BryoLogyx Inc. (“BryoLogyx”), pursuant to which BryoLogyx agreed to serve as the Company’s exclusive supplier of synthetic bryostatin. Pursuant to the terms of the Supply Agreement, the Company placed an initial order and subsequently received one gram of current good manufacturing practice (“cGMP”) synthetic bryostatin as an active pharmaceutical ingredient to be used in a drug product (“API”). The Company may place additional orders for API beyond the initial order by making a written request to BryoLogyx no later than six months prior to the requested delivery date. The Company is not currently using synthetic bryostatin for its current Phase 2 clinical trial and will determine when to incorporate the synthetic into the clinical trial process.

In connection with the Supply Agreement, on June 9, 2020, the Company entered into a transfer agreement (the “Transfer Agreement”) with BryoLogyx. Pursuant to the terms of the Transfer Agreement, the Company agreed to assign and transfer to BryoLogyx all of the Company’s right, title and interest in and to that certain Cooperative Research and Development Agreement, dated as of January 29, 2019 (the “CRADA”), by and between the Company and the U.S. Department of Health and Human Services, as represented by the NCI, under which Bryostatin-1’s ability to modulate CD22 in patients with relapsed/refractory CD22+ disease has been evaluated to date. Pursuant to guidance provided by NCI, the Company CRADA has been cancelled and BryoLogyx has initiated a request for a new CRADA in its name. BryoLogyx will be filing its own investigational new drug application (“IND”) for CD22 with the FDA. As consideration for the transfer of rights to the CRADA, BryoLogyx has agreed to pay to the Company 2% of the gross revenue received in connection with the sale of bryostatin products, up to an aggregate payment amount of $1 million. No such revenues have been earned as of June 30, 2023.

Nemours Agreement

On September 5, 2018, we announced a collaboration with Nemours A.I. DuPont Hospital (“Nemours”), a premier U.S. children’s hospital, to initiate a clinical trial in children with Fragile X syndrome, a genetic disorder. In addition to the primary objective of safety and tolerability, measurements will be made of working memory, language and other functional aspects such as anxiety, repetitive behavior, executive functioning, and social behavior. On August 5, 2021, the Company announced its memorandum of understanding with Nemours to initiate a clinical trial using Bryostatin-1, under Orphan Drug Status, to treat Fragile X. The Company intends to provide the Bryostatin-1 and obtain the IND, and Nemours intends to provide the clinical site and attendant support for the trial. The Company and Nemours, jointly, will develop the trial protocol. The Company estimates its total trial and IND cost to be approximately $2.0 million. As of June 30, 2023, the Company has incurred cumulative expenses associated with this agreement of approximately $100,000.

The Company has filed an IND with the FDA. The FDA has placed the development of the IND on clinical hold pending completion of further analytics relating to drug pharmacokinetics and pharmacodynamics. The Company is currently evaluating its plans to advance Fragile X development.

Cleveland Clinic

On February 23, 2022, the Company announced its collaboration with the Cleveland Clinic to pursue possible treatments for Multiple Sclerosis (“MS”), and on July 19, 2023, the Company announced that it had entered into an agreement with Cleveland Clinic to conduct a Phase 1 trial of Bryostatin-1 in MS. Cleveland Clinic will manage the clinical trial’s implementation, including an IND submission to the FDA and patient enrollment. The total estimated costs associated with this collaboration are approximately $2.0 million.

Cognitive Research Enterprises, Inc. (“CRE”)

Effective October 31, 2012, the Company executed a Technology License and Services Agreement (the “TLSA”) with CRE, a related party, and NRV II, LLC (“NRV II”), another affiliate of CRE, which was amended by Amendment No. 1 to the TLSA as of August 21, 2013, as amended and restated on February 4, 2015 (the “CRE License Agreement”). Pursuant to the CRE License Agreement, CRE and NRV II provide research services and have granted the Company the exclusive and nontransferable world-wide, royalty-bearing right, with a right to sublicense (in accordance with the terms and conditions described below), under CRE’s and NRV II’s respective right, title and interest in and to certain patents and technology owned by CRE or licensed to NRV II by CRE as of or subsequent to October 31, 2012, to develop, use, manufacture, market, offer for sale, sell, distribute, import and export certain products or services for therapeutic applications for AD and other cognitive dysfunctions in humans or animals (the “Field of Use”). Additionally, the CRE License Agreement specifies that all patents that issue from a certain patent application shall constitute licensed patents and all trade secrets, know-how and other confidential information claimed by such patents constitute licensed technology under the CRE License. The CRE License Agreement terminates on the later of the date (a) the last of the licensed patent expires, is abandoned, or is declared unenforceable or invalid or (b) the last of the intellectual property enters the public domain.

After Neurotrope’s initial Series A Stock financing, the CRE License Agreement required the Company to enter into scope of work agreements with CRE as the preferred service provider for any research and development services or other related scientific assistance and support services. There were no such statements of work agreements entered into during the years ended December 31, 2022 and 2021, respectively, or during the six months ended June 30, 2023.

In addition, on November 10, 2018, the Company and CRE entered into a second amendment (the “Second Amendment”) to the TLSA pursuant to which CRE granted certain patent prosecution and maintenance rights to the Company. Under the Second Amendment, the Company will have the sole and exclusive right and the obligation, to apply for, file, prosecute and maintain patents and applications for the intellectual property licensed to the Company, and pay all fees, costs and expenses related to the licensed intellectual property.

v3.23.2
Related Party Transactions
6 Months Ended
Jun. 30, 2023
Related Party Transactions  
Related Party Transactions

Note 4- Related Party Transactions:

On August 4, 2016, Neurotrope entered into a consulting agreement with SM Capital Management, LLC (“SMCM”), a limited liability company owned and controlled by the Company’s Chairman of the Board, Mr. Joshua N. Silverman (the “Consulting Agreement”). Pursuant to the Consulting Agreement, SMCM shall provide consulting services which shall include, but not be limited to, providing business development, financial communications and management transition services, for a one-year period, subject to annual review thereafter. SMCM’s annual consulting fee is $120,000, payable by the Company in monthly installments of $10,000. This contract was assigned to the Company as of December 1, 2020. For the three and six months ended June 30, 2023 and 2022, $30,000 and $60,000 is reflected in the Company’s statements of operations, respectively.

v3.23.2
Other Commitments
6 Months Ended
Jun. 30, 2023
Other Commitments  
Other Commitments

Note 5 – Other Commitments:

Clinical Trial Services Agreements

On July 23, 2020, the Company entered into the 2020 Services Agreement with WCT. The 2020 Services Agreement relates to services for the current Phase 2 clinical trial assessing the safety, tolerability and long-term efficacy of Bryostatin-1 in the treatment of moderately severe AD subjects not receiving memantine treatment (the “2020 Study”).On January 22, 2022, the Company executed a change order with WCT to accelerate trial subject recruitment totaling approximately $1.4 million. In addition, on February 10, 2022, the Company signed an additional agreement with a third-party vendor to assist with the increased trial recruitment retention totaling approximately $1.0 million which was subsequently canceled with no charges incurred by the Company. The updated total estimated budget for the current trial services, including pass-through costs, was approximately $11.0 million. As noted below, Neurotrope was granted a $2.7 million award from the National Institutes of Health, which award was used to support the Phase 2 Study, resulting in an estimated net budgeted cost of the Phase 2 Study to Neurotrope of $9.3 million. Synaptogenix may terminate the 2020 Services Agreement without cause upon 60 days prior written notice.

The Company was awarded a $2.7 million grant from the NIH, which will be used to support the 2020 Study, resulting in an estimated net budgeted cost of the 2020 Study to the Company of $8.3 million. The NIH grant provided for funds in the first year, which began in April 2020, of approximately $1.0 million and funding in year two, which began April 2021, of approximately $1.7 million. As of February 22, 2022, virtually all of the NIH grant has been received and offset against the clinical trial costs. The Company incurred approximately $10.5 million of cumulative expenses associated with the current Phase 2 clinical trial as of June 30, 2023. Of the total $10.5 million incurred for the trial as of June 30, 2023, approximately $77,000 and $0.4 million is reflected in the statement of operations for the three and six months ended June 30, 2023, respectively, and approximately $1.2 million and $4.6 million is reflected in the statement of operations for the three and six months ended June 30, 2022, respectively. As of June 30, 2023 included in the Company’s balance sheet, approximately $131,000 of WCT prepayments is included as a prepaid expense and other current assets. In addition, approximately $171,000 is included in accounts payable and accrued expenses.

On May 12, 2022, the Company entered into a services agreement with WCT (the “2022 Services Agreement”). The 2022 Services Agreement related to services for a Phase 2 “open label,” dose ranging study, clinical trial assessing the safety, tolerability and efficacy of Bryostatin-1 administered via infusion in the treatment of moderately severe to severe AD subjects not receiving memantine treatment (the “2022 Study”).

Pursuant to the terms of the 2022 Services Agreement, WCT provided services to enroll approximately twelve 2022 Study subjects. The first 2022 Study site was initiated during the third quarter of 2022. The total estimated budget for the services, including pass-through costs, is currently approximately $2.0 million. The Company terminated the 2022 Services Agreement in December 2022.

The Company incurred approximately $1.6 million of cumulative expenses associated with the current 2022 Study as of June 30, 2023. Of the total $1.6 million incurred for the trial as of June 30, 2023, approximately $33,000 and $157,000 is reflected in the statement of operations for the three and six months ended June 30, 2023, respectively and $0 for the comparable periods in 2022. As of June 30, 2023, $0 of WCT 2022 Study prepayments is included as a prepaid expense and other current assets in the Company’s balance sheet. In addition, approximately $55,000 is included in accounts payable and accrued expenses as of June 30, 2023.

Other Consulting Agreements

Effective as of January 1, 2021, the Company entered into an amended consulting agreement with Katalyst Securities LLC (“Katalyst”) reducing the cash payment to $20,000 per month. Effective as of January 1, 2022, the Company entered into an additional amended consulting agreement with Katalyst reducing the cash payment to $10,000 per month beginning February 1, 2022 through December 31, 2022 and eliminating any further warrant issuances. In addition, on February 16, 2021, Katalyst was granted warrants to purchase 25,000 shares of Common Stock at $11.46 per share; on April 1, 2021, was granted warrants to purchase an additional 4,500 shares of Common Stock at $8.80 per share; on July 1, 2021, was granted warrants to purchase an additional 4,500 shares of Common Stock at $9.76 per share; on October 1, 2021, was granted warrants to purchase an additional 4,500 shares of Common Stock at $9.30 per share; and on January 3, 2022, was granted warrants to purchase an additional 4,500 shares of Common Stock at $8.69 per share. For the three and six months ended June 30, 2023, $0 and $0 is reflected in the Company’s statements of operations, respectively and, for the three and six months ended June 30, 2022, $30,000 and $111,283 is reflected in the Company’s statements of operations, respectively. The Company uses the Black Scholes method to value its warrant issuances to Katalyst. All warrants assume a 0% dividend rate, have a term of five years and are expensed at fair value upon issuance. The Company terminated the Katalyst Agreement in December 2022.

Effective as of January 1, 2021, the Company entered into an amended consulting agreement with GP Nurmenkari, Inc. (“GPN”) (the “GPN Agreement”) reducing the cash payment to $12,000 per month. Effective as of July 1, 2021, the Company entered into a second amended consulting agreement with GPN increasing the cash payment to $20,000 per month and increasing warrants issued for each three-month period beginning July 1, 2021 to 5,800, with the last issuance on October 1, 2021. Effective as of January 1, 2022, the Company entered into an additional amended consulting agreement with GPN reducing the cash payment to $10,000 per month beginning February 1, 2022 through December 31, 2022 and eliminating any further warrant issuances. In addition, on February 16, 2021, GPN was granted warrants to purchase 10,000 shares of Common Stock at $11.46 per share; on April 1, 2021, was granted warrants to purchase an additional 2,500 shares of Common Stock at $8.80 per share; on July 1, 2021, was granted warrants to purchase an additional 5,800 shares of Common Stock at $9.76 per share; on October 1, 2021, was granted warrants to purchase an additional 5,800 shares of Common Stock at $9.30 per share; and on January 3, 2022, was granted warrants to purchase an additional 5,800 shares of Common Stock at $8.69 per share. For the three and six months ended June 30, 2023, $0 and $0 is reflected in the Company’s statements of operations, respectively and, for the comparable periods in 2022, $30,000 and $120,320 is reflected in the Company’s statements of operations, respectively. The Company uses the Black Scholes method to value its warrant issuances to GPN. All warrants assume a 0% dividend rate, have a term of five years and are expensed at fair value upon issuance. The Company terminated the GPN Agreement in December 2022.

Employment Agreements

On December 7, 2020, the Company entered into an offer letter (the “Offer Letter”) with Alan J. Tuchman, M.D., pursuant to which Dr. Tuchman agreed to serve as the Company’s Chief Executive Officer, commencing on December 7, 2020. In addition, in connection with his appointment as the Company’s Chief Executive Officer, Dr. Tuchman was appointed to the board of directors of the Company. Dr. Tuchman receives an annual base salary of $222,000, with an annual discretionary bonus of up to 50% of his base salary then in effect.

The term of Dr. Tuchman’s employment pursuant to the Offer Letter is one year, which shall be extended automatically for six-month periods unless either party gives timely written notice. Dr. Tuchman’s agreement was previously extended until December 7, 2022. On August 4, 2022, the Company entered into an amendment (the “Second Amendment”) to the Offer Letter to extend the term of Dr. Tuchman’s employment through June 7, 2023, and such term shall be extended for an additional six months upon Dr. Tuchman’s written notice to the Company at least 30 days prior to June 7, 2023. Pursuant to the Amendment, if Dr. Tuchman is terminated without Cause (as defined in the Offer Letter), Dr. Tuchman shall be entitled to severance equal to six months of Dr. Tuchman’s annual base salary. Effective June 7, 2023, the Company entered into an additional amendment to the Offer Letter to extend the term of Dr. Tuchman’s employment through June 7, 2024, with automatic monthly renewals thereafter unless earlier terminated in accordance with the terms of the Second Amendment.

Other Commitments and Agreements

See Notes 3 and 4 for Collaboration and License Agreement related commitments. 

Contingencies

Pursuant to the Separation Agreement and Tax Matters Agreement with Neurotrope, Neurotrope agreed to indemnify Synaptogenix for certain liabilities, and Synaptogenix agreed to indemnify Neurotrope for certain liabilities, in each case for uncapped amounts. Indemnities that Synaptogenix may be required to provide Neurotrope are not subject to any cap, may be significant and could negatively impact Synaptogenix’s business, particularly with respect to indemnities provided in the Tax Matters Agreement. Third parties could also seek to hold Synaptogenix responsible for any of the liabilities that Neurotrope has agreed to retain. Further, the indemnity from Neurotrope may not be sufficient to protect Synaptogenix against the full amount of such liabilities, and Neurotrope may not be able to fully satisfy its indemnification obligations. Moreover, even if Synaptogenix ultimately succeeds in recovering from Neurotrope any amounts for which Synaptogenix is held liable, Synaptogenix may be temporarily required to bear these losses ourselves. As of the reporting date, there are no claims relating to the indemnification agreement.

v3.23.2
Stockholders' Equity
6 Months Ended
Jun. 30, 2023
Stockholders' Equity  
Stockholders' Equity

Note 6 – Stockholders’ Equity:

The Company’s certificate of incorporation authorizes it to issue 150,000,000 shares of Common Stock and 1,000,000 shares of preferred stock, par value $0.0001 per share.

The holders of Common Stock are entitled to receive dividends out of assets or funds legally available for the payment of dividends at such times and in such amounts as the Board from time to time may determine. To date, the Company has not paid dividends on its Common Stock. Holders of Common Stock are entitled to one vote for each share held on all matters submitted to a vote of stockholders. There is no cumulative voting of the election of directors then standing for election. The Common Stock is not entitled to pre-emptive rights and is not subject to conversion or redemption. Upon liquidation, dissolution or winding up of the Company, the assets legally available for distribution to stockholders are distributable ratably among the holders of Common Stock after payment of liabilities, accrued dividends and liquidation preferences, if any. Each outstanding share of Common Stock is duly and validly issued, fully paid and non-assessable.

November 2022 Private Placement

On November 17, 2022, the Company entered into a Securities Purchase Agreement (as amended on May 11, 2023, the “November Purchase Agreement”) with certain accredited investors (the “November Investors”), pursuant to which it agreed to sell to the November Investors (i) an aggregate of 15,000 shares of the Company’s newly-designated Series B convertible preferred stock with a stated value of $1,000 per share (the “Series B Preferred Stock”), initially convertible into up to 1,935,485 shares of Common Stock at a conversion price of $7.75 per share (the “Series B Preferred Shares”), and (ii) warrants to acquire up to an aggregate of 1,935,485 shares of Common Stock (the “November Warrants”) (collectively, the “November Private Placement”). On May 12, 2023, the Company filed an amendment (the “CoD Amendment”) to the Certificate of Designations with the Secretary of State for the State of Delaware, pursuant to which the Company amended the terms of the Series B Preferred Stock by removing all references to the “Make-Whole Amount”.  In connection with the CoD Amendment, on May 11, 2023, the Company entered into an amendment to the November Purchase Agreement pursuant to which it agreed to extend the investors’ right of participation in a subsequent financing until the one year anniversary following the later of (x) such time that the Preferred Shares are no longer outstanding and (y) the maturity date of the Series B Preferred Stock.

The terms of the Series B Preferred Stock are as set forth in the Certificate of Designations for the Series B Preferred Stock (as amended on March 17, 2023 and May 12, 2023, the “Certificate of Designations”). The Series B Preferred Stock will be convertible into Series B Preferred Shares at the election of the holder at any time at an initial conversion price of $7.75 (the “Conversion Price”). The Conversion Price is subject to customary adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based adjustment in the event of any issuances of Common Stock, or securities convertible, exercisable or exchangeable for Common Stock, at a price below the then-applicable Conversion Price (subject to certain exceptions). The Company will be required to redeem the Series B Preferred Stock in 15 equal monthly installments, commencing on June 1, 2023. The amortization payments due upon such redemption are payable, at the Company’s election, in cash, or subject to certain limitations, in shares of Common Stock valued at the lower of (i) the Conversion Price then in effect and (ii) the greater of (A) a 15% discount to the average of the three lowest closing prices of the Common Stock during the thirty trading day period immediately prior to the date the amortization payment is due or (B) the lower of $1.25 and $0.172, which equals 20% of the Minimum Price (as defined in Rule 5635 of the Rule of the Nasdaq Stock Market) on April 14, 2023, the date of receipt of Nasdaq Stockholder Approval (as defined below); provided that if the amount set forth in clause B is the lowest effective price, the Company will be required to pay the amortization payment in cash. The Company may require holders to convert their Series B Preferred Stock into Series B Preferred Shares if the closing price of the Common Stock exceeds $11.625 per share for 20 consecutive trading days and the daily trading volume of the Common Stock exceeds 100,000 shares per day during the same period and certain equity conditions described in the Certificate of Designations are satisfied.

The holders of the Series B Preferred Stock will be entitled to dividends of 7% per annum, compounded monthly, which will be payable in cash or shares of Common Stock at the Company’s option, in accordance with the terms of the Certificate of Designations. Upon the occurrence and during the continuance of a Triggering Event (as defined in the Certificate of Designations), the Series B Preferred Stock will accrue dividends at the rate of 15% per annum. The holders of Series B Preferred Stock have no voting rights on account of the Series B Preferred Stock, other than with respect to certain matters affecting the rights of the Series B Preferred Stock.

Notwithstanding the foregoing, the Company’s ability to settle conversions and make amortization payments using shares of Common Stock is subject to certain limitations set forth in the Certificate of Designations, including a limit on the number of shares that may be issued until the time, if any, that the Company’s stockholders have approved the issuance of more than 19.9% of the Company’s outstanding shares of Common Stock in accordance with Nasdaq listing standards (the “Nasdaq Stockholder Approval”). The Company agreed to seek stockholder approval of these matters at a meeting to be held no later than June 1, 2023, and such approval was obtained at the Company’s special meeting of stockholders held on April 14, 2023. Further, the Certificate of Designations contains a certain beneficial ownership limitation after giving effect to the issuance of shares of Common Stock issuable upon conversion of, or as part of any amortization payment under, the Certificate of Designations or November Warrants.

The Certificate of Designations includes certain Triggering Events (as defined in the Certificate of Designations), including, among other things, the failure to file and maintain an effective registration statement covering the sale of the holder’s securities registrable pursuant to the November Registration Rights Agreement (defined below) and the Company’s failure to pay any amounts due to the holders of the Series B Preferred Stock when due. In connection with a Triggering Event, each holder of Series B Preferred Stock will be able to require the Company to redeem in cash any or all of the holder’s Series B Preferred Stock at a premium set forth in the Certificate of Designations.

The Company will be subject to certain affirmative and negative covenants regarding the incurrence of indebtedness, acquisition and investment transactions, the existence of liens, the repayment of indebtedness, the payment of cash in respect of dividends (other than dividends pursuant to the Certificate of Designations), distributions or redemptions, and the transfer of assets, among other matters.

The November Warrants are exercisable for Warrant Shares immediately at an exercise price of $7.75 per share (the “Exercise Price”) and expire five years from the date of issuance. The Exercise Price is subject to customary adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based adjustment, on a “full ratchet” basis, in the event of any issuances of Common Stock, or securities convertible, exercisable or exchangeable for Common Stock, at a price below the then-applicable Exercise Price (subject to certain exceptions). There is no established public trading market for the November Warrants and the Company does not intend to list the November Warrants on any national securities exchange or nationally recognized trading system.

In connection with the November Purchase Agreement, the Company and the November Investors entered into a Registration Rights Agreement (the “November Registration Rights Agreement”) on November 17, 2022. Under the terms of the November Registration Rights Agreement, the Company agreed to register 200% of the Series B Preferred Shares, the Warrant Shares and the shares of Common stock issuable as amortization payments as well as any shares of Common stock paid as dividends. The Company filed a registration statement for the resale of such securities on December 16, 2022. The Company also agreed to other customary obligations regarding registration, including indemnification and maintenance of the effectiveness of the registration statement.

In connection with the November Private Placement, pursuant to an Engagement Letter, between the Company and Katalyst Securities LLC (the “November Placement Agent”), the Company paid the November Placement Agent (i) a cash fee equal to 7% of the gross proceeds from any sale of securities in the November Private Placement and (ii) warrants to purchase shares of Common Stock equal to 3% of the number of shares of Common stock that the Series B Preferred Shares are initially convertible into, with an exercise price of $7.75 per share and a five-year term.

On June 1, 2023, the Company paid the holders of the Series B Preferred Stock approximately $1.64 million to satisfy the first amortization payment due. On June 30, 2023, the holders of the Series B Preferred Stock elected to defer the cash payment due on July 1, 2023 of approximately $1.14 million to August 1, 2023.  On July 13, 2023, the holders of the Series B Preferred Stock elected to convert cash payments due on August 1, 2023 of approximately $2.16 million into 3,125,907 shares of Common Stock. On July 31, 2023, the holders of the Series B Preferred Stock elected to defer cash payments due on August 1, 2023 of approximately $953,000 to September 1, 2023. On August 1, 2023, the Company provided notice to the Series B Preferred Stock investors that it would issue 1,680,675 shares of pre-amortization Common Stock to satisfy the amortization payment due September 1, 2023. As of August 10, 2023, 2,799,249 total shares of Common Stock have been issued to the holders of the Series B Preferred Stock.

Accounting Treatment of November Private Placement

Series B Preferred Shares

Effective April 14, 2023, the Company amended the Certificate of Designations of Series B Convertible Preferred Stock. The amendment modified (i) the definition of Floor Price to mean the lower of (i) $1.25 and (ii) 20% of the “Minimum Price” (as defined in Rule 5635 of the Rule of the Nasdaq Stock Market) on the date of receipt of Stockholder Approval (as defined in the Agreement), (ii) the definition of Installment Date to mean June 1, 2023, and thereafter, the first Trading Day of each calendar month immediately following the previous Installment Date until the Maturity Date, and the Maturity Date, and (iii) the definition of Maturity Date to mean August 31, 2023. In accordance with ASC 470-50 and 470-60, the Company has made an accounting policy election to account for amendments of the Series B Preferred Stock as modifications or extinguishments based on the change in fair value of the instrument immediately before and immediately after the amendment. The Company accounted for the amendment as an extinguishment as the change in fair value of the Series B Preferred Stock was 34% (greater than ten percent (10%)) immediately before and immediately after. In accordance with ASC 260-10-S99-2, the Company recognized the $5.7 million increase in fair value as a deemed dividend on the statement of operations.

On May 11, 2023, the Company amended the Certificate of Designations of Series B Convertible Preferred Stock. The amendment removed the definition of Make-Whole Amount (as was previously defined in the Agreement) and modified the definition of the Conversion Amount so as to remove the Make-Whole Amount from said definition. In accordance with ASC 470-50 and 470-60, the Company accounted for the amendment as a modification as the change in fair value of the Series B Preferred Stock was 0.05% (less than ten percent (10%)) immediately before and immediately after. The Company analogized to the share-based payments model for the appropriate modification accounting and did not recognize a deemed dividend as the fair value decreased upon modification.

The Series B Preferred Shares were determined to be more akin to a debt-like host than an equity-like host. The Company identified the following embedded features that are not clearly and closely related to the debt host instrument: 1) make-whole interest upon a contingent redemption event, 2) make-whole interest upon a conversion event, 3) an installment redemption upon an Equity Conditions Failure (as defined in the Certificate of Designation), and 4) variable share-settled installment conversion. These features were bundled together, assigned probabilities of being affected and measured at fair value. Subsequent changes in fair value of these features are recognized in the Consolidated Statement of Operations. The Company estimated the $2.2 million fair value of the bifurcated embedded derivative at issuance using a Monte Carlo simulation model, with the following inputs: the fair value of our Common stock of $6.52 on the issuance date, estimated equity volatility of 85.0%, estimated traded volume volatility of 255.0%, the time to maturity of 1.61 years, a discounted market interest rate of 7.3%, dividend rate of 7%, a penalty dividend rate of 15.0%, and probability of default of 8.2%. The fair value of the bifurcated derivative liability was estimated utilizing the with and without method which uses the probability weighted difference between the scenarios with the derivative and the plain vanilla maturity scenario without a derivative.

The discount to the fair value is included as a reduction to the carrying value of the Series B Preferred Shares. During 2022, the Company recorded a total discount of approximately $12.3 million upon issuance of the Series B Preferred Shares, which was comprised of the issuance date fair value of the associated embedded derivative of approximately $2.2 million, stock issuance costs of approximately $0.5 million and the fair value of the Warrants of approximately $9.6 million. During the three months ended June 30, 2023, it was deemed probable that the Series B Preferred Shares will be redeemed for cash upon Installment Redemptions (as defined the Certificate of Designation). As such, the Company recognized $2,455,656 to additional paid-in capital to accrete the Series B Preferred Shares to redemption amount pursuant to ASC 480-10-S99-3A with a corresponding increase in the carrying value of the Series B Preferred Shares.

During the three and six months ended June 30, 2023, the Company recorded a loss of $2,484,400 and $2,258,600, respectively, and $0 for the comparable periods in 2022, related to the change in fair value of the derivative liability which is recorded in other income (expense) on the Statements of Operations. The Company estimated the $2,628,000 fair value of the bifurcated embedded derivative at June 30, 2023 using a Monte Carlo simulation model, with the following inputs: the fair value of our Common stock of $0.93 per share on the valuation date, estimated equity volatility of 145%, estimated traded volume volatility of 240%, the time to maturity of 1.7 years, a discounted market interest rate of 6.5%, dividend rate of 7%, a penalty dividend rate of 15.0%, and probability of default of 0.9%.

Common Stock Warrants

Pursuant to the Private Placement, the Company issued to investors Warrants and, pursuant to its advisory agreements, the Company issued to its advisor additional Warrants with the same terms. The Broker Warrants are within the scope of ASC 718 pursuant to ASC 718-10-20 but are subject to liability classification as they would be required to be classified as liabilities in accordance with ASC 480.

The Warrants were determined to be within the scope of ASC 480-10 as they are puttable to the Company at Holders’ election upon the occurrence of a Fundamental Transaction (as defined in the agreements). As such, the Company recorded the Warrants as a liability at fair value with subsequent changes in fair value recognized in earnings. The Company utilized the Black Scholes Model to calculate the value of these warrants issued during the year ended December 31, 2022. The fair value of the Warrants of approximately $9.9 million was estimated at the date of issuance using the following weighted average assumptions: dividend yield 0%; expected term of five years; equity volatility of 105%; and a risk-free interest rate of 3.97%.

Transaction costs incurred attributable to the issuance of the Warrants of $0.9 million were immediately expensed in accordance with ASC 480.

During the three and six months ended June 30, 2023 and 2022, the Company recorded a loss of $207,000 and a gain of $381,000, respectively, and $0 for comparable periods in 2022, related to the change in fair value of the warrant liability which is recorded in other income (expense) on the Statements of Operations. The fair value of the Warrants of approximately $1,129,000 was estimated at June 30, 2023 utilizing the Black Scholes Model using the following weighted average assumptions: dividend yield 0%; remaining term of 4.38 years; equity volatility of 130%; and a risk-free interest rate of 4.24%.

v3.23.2
Stock Based Compensation
6 Months Ended
Jun. 30, 2023
Stock Based Compensation  
Stock Based Compensation

Note 7 – Stock Based Compensation:

 

2020 Equity Incentive Plan

 

Upon completion of the Spin-Off, the Company’s 2020 Equity Incentive Plan (the “2020 Plan”) became effective on December 7, 2020. The total number of securities available for grant under the 2020 Plan was 250,000 shares of Common Stock, subject to adjustment. On April 7, 2021, the Company held a special meeting of stockholders at which the Company’s stockholders approved an amendment to the Company’s 2020 Plan to increase the total number of shares of Common Stock from 250,000 to an aggregate of 625,000. On October 11, 2022, the Company held its annual meeting of stockholders at which the Company’s stockholders approved an amendment to the Company’s 2020 Plan to increase the total number of shares of Common Stock authorized for issuance from 625,000 to an aggregate of 1,375,000 shares.

The Compensation Committee of the Company’s board of directors (the “Committee”) administers the 2020 Plan and has full power to grant stock options and Common Stock, construe and interpret the 2020 Plan, establish rules and regulations and perform all other acts, including the delegation of administrative responsibilities, as it believes reasonable and proper. The Committee, in its absolute discretion, may award Common Stock to employees, consultants, and directors of the Company, and such other persons as the Committee may select, and permit holders of options to exercise such options prior to full vesting.

Stock and Option Grants

The following is a summary of stock option activity under the stock option plans for the three months ended June 30, 2023:

    

    

    

Weighted-

    

Average

Aggregate

Weighted-

Remaining

Intrinsic

Number

Average

Contractual

Value

of

Exercise

Term

(in

Shares

Price

(Years)

millions)

Options outstanding at January 1, 2023

 

661,850

$

7.27

 

9.5

$

Options granted

 

80,000

$

0.87

 

10.0

 

Less options forfeited

 

$

 

 

Less options expired/cancelled

 

$

 

 

Less options exercised

 

$

 

 

Options outstanding at June 30, 2023

 

741,850

$

6.15

 

9.1

$

Options exercisable at June 30, 2023

 

661,850

$

6.08

 

9.0

$

The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying awards and the closing stock price of $0.923 for the Company’s common shares on June 30, 2023 and the closing stock price of $1.16 for the Company’s common shares on December 31, 2022.

As of June 30, 2023, the Company had unrecognized stock option expense of approximately $45,000 and a remaining weighted average period for recognition of 0.75 years.

On February 16, 2022, pursuant to its 2020 Plan, the Company granted stock options to purchase an aggregate of 6,150 shares of Common Stock to its Chief Executive Officer. The stock options have an exercise price of $7.29 per share and an expiration date that is ten years from the date of issuance. As of February 16, 2023, these stock options are fully vested. The Company used the Black Scholes valuation method to determine the fair value of the options assuming the following: implied volatility of 112.75%, a risk free interest rate of 2.05% and a fair value of $42,108. The options were expensed over the one-year vesting period from date of issuance.

On November 15, 2022, pursuant to its 2020 Plan, the Company granted stock options to six Board members, including two officers who are also Board members, and two employees to purchase an aggregate of 531,850 shares of Common Stock. The stock options have an exercise price of $6.07 per share and an expiration date that is ten years from the date of issuance. 50% of the options vest upon issuance with the remaining 50% vesting on May 15, 2023. The Company used the Black Scholes valuation method to determine the fair value of the options assuming the following: implied volatility of 107.05%, a risk free interest rate of 3.93% and have a fair value of $2,570,328. The options are being expensed 50% at date of issuance and the remaining 50% expensed on a straight line basis over the six-month vesting period from date of issuance.

On March 29, 2023, Synaptogenix granted stock options to four Board members to purchase an aggregate of 80,000 shares of common stock. The stock options have an exercise price of $.87 per share and an expiration date of ten years. They vest on the one-year anniversary from the date of the grant. The Company used the Black Scholes valuation method to determine the fair value of the options assuming the following: implied volatility of 123.92%, a risk free interest rate of 3.66% and have a fair value of $59,763.

Director’s Compensation Policy

On March 29, 2023, Synaptogenix adopted an amended and restated non-employee director compensation policy (the “Director Compensation Policy”). The Director Compensation Policy provides for the annual automatic grant of nonqualified stock options to purchase up to 20,000 shares of Synaptogenix’s Common Stock to each of Synaptogenix’s non-employee directors. Such grants shall occur annually on the fifth business day after the filing of Synaptogenix’s Annual Report on Form 10-K, if available under the Plan, and shall vest on the one-year anniversary from the date of grant, subject to the director’s continued service on the Board of Directors on the vesting date. Each newly appointed or elected director will also receive 20,000 options, and such options shall vest 50% on the grant date, 25% on the first anniversary of the grant date and 25% on the second anniversary of the grant date, subject to the director’s continued service on the Board of Directors on each vesting date.

The Company recorded total expenses relating to the outstanding stock options of $334,416 and $979,207 for the three and six months ended June 30, 2023, and $11,544 and $47,918 for the three and six months ended June 30, 2022, respectively.

Restricted Stock Unit Grants

On July 13, 2021, the Company granted a total of 495,000 restricted stock units (RSUs), of which 425,000 were granted to seven Board members (including two executives), 60,000 to the Company’s CFO and 10,000 to two employees. On November 30, 2022, one director and one officer forfeited a total of 86,000 RSUs to satisfy the 2020 Plan limitation of total issuances per year to any individual holder. The Company reversed approximately $370,000 of expense resulting from the forfeited RSUs. The RSUs were amended on January 12, 2022, to vest 100% on September 15, 2022 and then further amended on June 20, 2022 to vest 100% on the earlier of release of Phase 2 clinical trial top line data or December 31, 2022. Top line data was announced on December 16, 2022, and so the RSUs vested on such date.

As of December 31, 2022, 100% of the 411,000 RSUs vested and were exercised. As of June 30, 2023 and December 31, 2022, the Company had unrecognized stock option and RSU expense of approximately $0 and $2.56 million, respectively. The fair value of the RSUs issued was based upon the closing trading price of the Company’s Common stock on the grant date of $9.75 per share. The grant date fair value of the RSUs granted was approximately $4.8 million. The Company recorded total expense, using straight line method over the vesting period of the RSUs, of $0 for the six months ended June 30, 2023 and $1,005,146 and $1,680,330 relating to the RSUs for the three and six months ended June 30, 2022, respectively.

Restricted Stock Issuances

On February 15, 2022, the Company granted 13,775 shares of restricted stock to two consultants that were engaged to provide investor relations services with a total fair market value on date of issuance of $91,429. On March 14, 2022, the Company granted 692 shares of restricted stock to a consultant that was engaged to provide investor relations services with a total fair market value on date of issuance of $4,500. On June 7, 2022, the Company granted 679 shares of restricted stock to a consultant that was engaged to provide investor relations services with a total fair market value on date of issuance of $4,500. On July 8, 2022, the Company granted 30,303 shares of restricted stock to a consultant that was engaged to provide investor relations services with a total fair market value on date of issuance of $150,000 and warrants to purchase 15,459 shares of Common Stock with an exercise price of $13.26 per share for a period of five years from the date of issuance. The Company used the Black Scholes valuation method to determine fair value assuming the following: implied volatility of 112.75%, a risk free interest rate of 3.05% and a fair value of $75,000. The warrants are expensed over the three-month term of the consulting agreement. On September 8, 2022, the Company issued 540 shares of restricted stock to a consultant that was engaged to provide investor relations services with a total fair market value on date of issuance of $4,500. All stock issuances are expensed upon issuance.

On October 8, 2022, the Company issued 6,878 shares of restricted stock to a consultant that was engaged to provide investor relations services with a total fair market value on date of issuance of $50,000 and warrants to purchase 4,659 shares of Common Stock with an exercise price of $14.54 per share for a period of five years from the date of issuance. The Company used the Black Scholes valuation method to determine fair value assuming the following: implied volatility of 112.75%, a risk free interest rate of 4.14%, a fair

value of $25,000 and are expensed upon issuance. During November 2022, the Company issued to Sherwood 7,092 shares of restricted Common Stock valued at $50,000 and were expensed when issued, and warrants to purchase 4,795 shares of Common Stock, with an exercise price of $14.10 per share. The Company used the Black Scholes valuation method to determine fair value assuming the following: implied volatility of 112.75%, a risk free interest rate of 4.39% and a fair value of $25,000. The warrants are expensed when issued. On December 7, 2022, the Company issued 893 shares of restricted stock to a consultant that was engaged to provide investor relations services with a total fair market value on date of issuance of $4,501, expensed upon issuance.

On January 5, 2023, the Company issued 88,339 shares of restricted stock to a consultant that was engaged to provide investor relations services with a total fair market value on date of issuance of $100,000. On March 22, 2023, the Company issued 4,500 shares of restricted stock to a consultant that was engaged to provide investor relations services with a total fair market value on date of issuance of $4,500, expensed upon issuance. On June 7, 2023, the Company issued 5,409 shares of restricted stock to a consultant that was engaged to provide investor relations services with a total fair market value on date of issuance of $4,500, expensed upon issuance.

Stock Compensation Expense

Total stock-based compensation for the three and six months ended June 30, 2023 was $334,416 and 979,197, respectively, of which $49,863 and $149,589, respectively, was classified as research and development expense, and $284,553 and $829,608 was classified as general and administrative expense, respectively. Total stock-based compensation for the three and six months ended June 30, 2022 was $1,016,690 and $1,728,248, respectively, of which $172,601 and $293,651, respectively, was classified as research and development expense, and $844,089 and $1,434,597 was classified as general and administrative expense, respectively.

The Company currently estimates, beginning at the closing date of the November Private Placement, implied volatility factor for all options and warrants based upon a blend of the Parent Company’s and Company’s historical volatility. Up until November 21, 2022, the Company computed implied volatility based upon a blend of the Parent Company’s and Company’s historical volatility along with the volatility of selected comparable publicly traded companies as, at that time, the Company lacked sufficient historical stock trading activity. It incorporated the historical volatility of the Parent Company as the Parent Company’s historical volatility provides a good estimation of the Company’s volatility since its operations were identical to the Company’s prior to the spin-out.

v3.23.2
Common Stock Warrants
6 Months Ended
Jun. 30, 2023
Common Stock Warrants  
Common Stock Warrants

Note 8 – Common Stock Warrants:

 

As of June 30, 2023, the Company had warrants outstanding consisting of the following:

    

Number

of shares

Warrants outstanding January 1, 2022

 

6,265,525

Warrants issued

 

2,028,762

Warrants exercised

 

(65,000)

Warrants expired

(1,049,368)

Warrants outstanding and exercisable December 31, 2022 and June 30, 2023

 

7,179,919

On January 3, 2022, pursuant to its advisory agreements, the Company issued warrants to purchase 10,300 shares of Common Stock, with an exercise price of $8.96 per share, for a period of five years from the issuance date. The Company used the Black-Scholes valuation model to calculate the value of these warrants issued to advisors during the year ended December 31, 2022. The fair value of the warrants was estimated at the date of issuance using the following weighted average assumptions: Dividend yield 0%; Expected term five years; weighted average implied volatility of 111.8%; and a weighted average Risk-free interest rate of 2.38%. The total expense recorded during the three and six months ended June 30, 2023 was $0 and $71,603, respectively.

On November 22, 2022, pursuant to the November Private Placement (See Note 6 above), the Company issued warrants to purchase 1,993,485 shares of Common Stock, immediately exercisable with at an exercise price of $7.75 per share and expiring five years from the date of issuance. The Exercise Price is subject to customary adjustments for stock dividends, stock splits, reclassifications and the like, and subject to price-based adjustment, on a “full ratchet” basis, in the event of any issuances of Common Stock, or securities convertible, exercisable or exchangeable for Common Stock, at a price below the then-applicable Exercise Price (subject to certain exceptions). The fair value of the warrants was estimated at the date of issuance using the following weighted average assumptions: Dividend yield 0%, Expected term five years; weighted average implied volatility of 105% and a weighted average Risk-free interest

rate of 3.97%. The total value recorded during the year period, classified as a liability on the Company’s balance sheet in November 2022, is approximately $9.6 million. As of June 30, 2023, the liability is $1,129,000.

As of June 30, 2023, the weighted average exercise price and the weighted average remaining life of the total warrants were $11.79 per warrant and 3.17 years, respectively. The intrinsic value of the warrants as of June 30, 2023 was approximately $134,800. The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying awards and the closing stock price of $0.928 for the Company’s common shares on June 30, 2023.

During the six months ended June 30, 2022, three affiliated warrant holders exercised 50,000 Series E Warrants to purchase 50,000 shares of Common Stock at $8.51 per share and one holder exercised 15,000 Series G Warrants to purchase 15,000 shares of Common Stock at $8.51 per share. During the three months ended June 30, 2022, no warrant holders exercised warrants. Total cash proceeds from these warrant exercises was $553,150. During the three and six months ended June 30, 2023, no warrant holders exercised warrants.

v3.23.2
Fair Value Measurements
6 Months Ended
Jun. 30, 2023
Fair Value Measurements  
Fair Value Measurements

Note 9 - Fair Value Measurements

Fair value measurements discussed herein are based upon certain market assumptions and pertinent information available to management as of and during the six months ended June 30, 2023 and 2022. The carrying amounts of cash equivalents, accounts receivable, other current assets, other assets, accounts payable, and accrued expenses approximated their fair values as of June 30, 2023 and December 31, 2022 due to their short-term nature. The fair value of the bifurcated embedded derivative related to the convertible preferred stock was estimated using a Monte Carlo simulation model, which uses as inputs the fair value of our Common stock and estimates for the equity volatility and traded volume volatility of our Common stock, the time to maturity of the convertible preferred stock, the risk-free interest rate for a period that approximates the time to maturity, dividend rate, a penalty dividend rate, and our probability of default. The fair value of the warrant liability was estimated using the Black Scholes Model which uses as inputs the following weighted average assumptions, as noted above: dividend yield, expected term in years, equity volatility, and risk-free interest rate.

Fair Value on a Recurring Basis

The Company follows the guidance in ASC 820 for its financial assets and liabilities that are re-measured and reported at fair value at each reporting period, and non-financial assets and liabilities that are re-measured and reported at fair value at least annually. The estimated fair value of the warrant liability and bifurcated embedded derivatives represent Level 3 measurements. The following table presents information about the Company’s liabilities that are measured at fair value on a recurring basis at June 30, 2023 and December 31, 2022, and indicates the fair value hierarchy of the valuation inputs the Company utilized to determine such fair value:

June 30,

December 31,

Description

    

Level

    

2023

    

2022

Liabilities:

 

  

 

  

 

  

Warrant liability (Note 6)

 

3

$

1,129,000

$

1,510,000

Bifurcated embedded derivative liability (Note 6)

 

3

$

2,628,000

$

370,300

The following table sets forth a summary of the change in the fair value of the warrant liability that is measured at fair value on a recurring basis:

    

December 31, 2022

Balance on December 31, 2021

$

Issuance of warrants

 

9,915,000

Change in fair value of warrant liability

 

(8,405,000)

Balance on December 31, 2022

$

1,510,000

Change in fair value of warrant liability

 

(381,000)

Balance on June 30, 2023

$

1,129,000

The following table sets forth a summary of the change in the fair value of the bifurcated embedded derivative liability that is measured at fair value on a recurring basis:

    

December 31, 2022

Balance on December 31, 2021

$

Issuance of convertible preferred stock with bifurcated embedded derivative

 

2,191,300

Change in fair value of bifurcated embedded derivative

 

(1,821,900)

Balance on December 31, 2022

$

369,400

Change in fair value of warrant liability

 

2,258,600

Balance on June 30, 2023

$

2,628,000

v3.23.2
Subsequent Events
6 Months Ended
Jun. 30, 2023
Subsequent Events  
Subsequent Events

Note 10 – Subsequent Events

See Note 6 above.

v3.23.2
Summary of Significant Accounting Policies (Policies)
6 Months Ended
Jun. 30, 2023
Summary of Significant Accounting Policies  
Basis of Presentation

Basis of Presentation:

The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial reporting and with the instructions to Form 10-Q and Article 10 of Regulation S-X. In the opinion of management, the unaudited condensed financial statements included herein contain all adjustments necessary to present fairly the Company’s financial position and the results of its operations and cash flows for the interim periods presented. Such adjustments are of a normal recurring nature. The results of operations for the three and six months ended June 30, 2023 may not be indicative of results for the full year. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and the notes to those statements for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 21, 2023.

Use of Estimates

Use of Estimates:

The preparation of financial statements in conformity with GAAP requires management to make significant estimates that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Management evaluates its estimates on an ongoing basis using historical experience and other factors, including the general economic environment and actions it may take in the future. The Company adjusts such estimates when facts and circumstances dictate. However, these estimates may involve significant uncertainties and judgments and cannot be determined with precision. In addition, these estimates are based on management’s best judgment at a point in time and as such these estimates may ultimately differ from actual results.

Comprehensive Income (Loss)

Comprehensive Income (Loss)

The Company follows FASB ASC 220 in reporting comprehensive income (loss). Comprehensive income (loss) is a more inclusive financial reporting methodology that includes disclosure of certain financial information that historically has not been recognized in the calculation of net income (loss). Since the Company has no items of other comprehensive income (loss), comprehensive loss is equal to net loss for all periods presented.

Net Earnings or Loss per Share

Net Earnings or Loss per Share:

Net earnings or loss per share is computed by dividing net income or loss by the weighted-average number of shares of common stock outstanding during the period, excluding shares subject to redemption or forfeiture. The Company presents basic and diluted net earnings or loss per share. Diluted net earnings or loss per share reflect the actual weighted average of shares of common stock issued and outstanding during the period, adjusted for potentially dilutive securities outstanding. Potentially dilutive securities are excluded from the computation of the diluted net earnings or loss per share if their inclusion would be anti-dilutive.

As all potentially dilutive securities are anti-dilutive as of June 30, 2023 and 2022, diluted net loss per share is the same as basic net loss per share for the three and six months ended June 30, 2023 and 2022.

The weighted average dilutive securities that have been excluded from the calculation of diluted net loss per share for the three and six months ended June 30, 2023 and 2022 respectively, because to do so would be anti-dilutive (in Common Stock equivalents), are as follows:

For the Three Months Ended

For the Six Months Ended

    

June 30,

 

June 30,

2023

2022

2023

2022

Common Stock Options

 

741,850

 

130,000

703,183

128,428

Restricted Stock Units

 

 

495,000

495,000

Convertible Preferred Stock

17,876,707

17,876,707

Common Stock Warrants

 

7,179,919

 

5,487,927

7,179,919

5,855,262

Total

 

25,798,476

 

6,112,927

25,759,809

6,478,690

Cash and Cash Equivalents and Concentration of Credit Risk

Cash and Cash Equivalents and Concentration of Credit Risk:

The Company considers all highly liquid cash investments with an original maturity of three months or less when purchased to be cash equivalents. At June 30, 2023, the Company’s cash balances that exceed the current insured amounts under the Federal Deposit Insurance Corporation (“FDIC”) were approximately $2.2 million. In addition, approximately $30.7 million included in cash and cash equivalents were invested in a money market fund, which is not insured under the FDIC.

Fair Value of Financial Instruments

Fair Value of Financial Instruments:

The carrying amounts reflected in the balance sheets for payables approximate fair value due to the short maturities of these instruments. The carrying amounts for warrant liability and derivative liability approximate fair value based on level 3 of the fair value hierarchy.

Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy:

Level 1 — Quoted prices in active markets for identical assets or liabilities.

Level 2 — Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable markets.

Level 3 — Unobservable inputs which are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.

Fixed Assets and Leases

Fixed Assets and Leases:

The Company has two leases, one of which has a term of two years during the respective reporting periods. The Company has deemed the two year lease immaterial and has not recorded it as an obligation on the balance sheet nor a right-of-use asset.  The total future expense relating to this lease is approximately $50,000 per year.

Fixed assets are stated at cost less accumulated depreciation. Depreciation is computed on a straight line basis over the estimated useful life of the asset, which is deemed to be between three and ten years.

Research and Development Costs

Research and Development Costs:

All research and development costs, including costs to maintain or expand the Company’s patent portfolio licensed from CRE are expensed when incurred. Non-refundable advance payments for research and development are capitalized because the right to receive those services represents an economic benefit. Such capitalized advances will be expensed when the services occur and the economic benefit is realized. There were no capitalized research and development services, other than non-refundable advance payments as mentioned below for Worldwide Clinical Trials, Inc. (“WCT”), at June 30, 2023 and December 31, 2022.

Income Taxes

Income Taxes:

The Company accounts for income taxes using the asset and liability approach which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and amounts reportable for income tax purposes under the “Separate return method.” Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more-likely-than-not that some portion or all of the deferred tax assets will not be realized.

The Company applies the provisions for accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold and measurement process for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The Company has determined that there are no significant uncertain tax positions requiring recognition in the accompanying financial statements. The tax period that is subject to examination by major tax jurisdictions is generally three years from the date of filing.

The Company had federal and state net operating loss carryforwards for income tax purposes of approximately $93.4 million for the period from October 31, 2012 (inception) through June 30, 2023. The net operating loss carryforwards resulted in Federal and state deferred tax asset of approximately $27.4 million at June 30, 2023. Income tax effects of share-based payments are recognized in the financial statements for those awards that will normally result in tax deductions under existing tax law. However, the deferred tax asset is offset by a full valuation allowance.

The Company may be subject to significant U.S. federal income tax-related liabilities with respect to the Spin-Off if there is a determination that the Spin-Off is taxable for U.S. federal income tax purposes. In connection with the Spin-Off, the Company believes that, among other things, the Spin-Off should qualify as a tax-free transaction for U.S. federal income tax purposes under Section 355 and Section 368(a)(1)(D) of the Internal Revenue Code of 1986 (the “Code”). If the conclusions of the tax opinions are not correct, or if the Spin-Off is otherwise ultimately determined to be a taxable transaction, the Company would be liable for U.S. federal income tax related liabilities. Pursuant to the Separation and Distribution Agreement and the Tax Matters Agreement, Neurotrope agreed to indemnify Synaptogenix for certain liabilities, and Synaptogenix agreed to indemnify Neurotrope for certain liabilities, in each case for uncapped amounts. Indemnities that Synaptogenix may be required to provide Neurotrope are not subject to any cap, may be significant and could negatively impact Synaptogenix’s business, particularly with respect to indemnities provided in the Tax Matters Agreement. Third parties could also seek to hold Synaptogenix responsible for any of the liabilities that Neurotrope has agreed to retain. Further, the indemnity from Neurotrope may not be sufficient to protect Synaptogenix against the full amount of such liabilities, and Neurotrope may not be able to fully satisfy its indemnification obligations. Moreover, even if Synaptogenix ultimately succeeds in recovering from Neurotrope any amounts for which Synaptogenix is held liable, Synaptogenix may be temporarily required to bear these losses. At June 30, 2023 and as of the date of financial statement issuance date, the Company does not have any indemnification liabilities.

Under Section 382 of the Code, as amended, changes in the Company’s ownership may limit the amount of its net operating loss carryforwards that could be utilized annually to offset future taxable income, if any. This limitation would generally apply in the event of a cumulative change in ownership of the Company of more than 50% within a three-year period. In addition, the significant historical operating losses incurred by the Company may limit the amount of its net operating loss carryforwards that could be utilized annually to offset future taxable income, if any. The Company believes that operating loss carryforwards are limited under Section 382 limitations although Section 382 studies have not been conducted to determine the actual limitations.

Expense Reimbursement for Grant Award

Expense Reimbursement for Grant Award:

The Company reduces its research and development expenses by funding received or receivable from an NIH grant during the period that the expenses are incurred. The Company recognized grant related expense reductions during the six months ended June 30, 2023 of $0 and approximately $100,000 for the three and six months ended June 30, 2022. See Note 5, “Other Commitments – Clinical Trial Services Agreements.”

Of the total $2.7 million available from the NIH grant, the Company has received the maximum reimbursements under the grant as of June 30, 2023.

Recent Accounting Pronouncements

Recent Accounting Pronouncements:

In August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2020-06, which reduces the number of accounting models for convertible instruments, amends diluted earnings per share calculations for convertible instruments and allows more contracts to qualify for equity classification. ASU 2020-06 will be effective for interim and annual periods beginning after December 15, 2021. The Company has adopted ASU 2020-06 as of January 1, 2022.

In June 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). This standard establishes an impairment model (known as the current expected credit loss (“CECL”) model) that is based on expected losses rather than incurred losses. Under the new guidance, an entity recognizes as an allowance its estimate of expected credit losses, which is intended to result in a timelier recognition of losses. Under the CECL model, entities will estimate credit losses over the entire contractual term of the instrument (considering estimated prepayments, but not expected extensions or modifications) from the date of initial recognition of the financial instrument. Measurement of expected credit losses are to be based on relevant forecasts that affect collectability. The scope of financial assets within the CECL methodology is broad and includes trade receivables from certain revenue transactions and certain off-balance sheet credit exposures. Different components of the guidance require modified retrospective or prospective adoption.

In November 2018, the FASB issued ASU No. 2018-19, Codification Improvements to Topic 326, Financial Instruments-Credit Losses. ASU 2018-19 clarifies that receivables arising from operating leases are not within the scope of the credit losses standard. Instead, entities would need to apply other U.S. GAAP, namely Topic 842 (Leases), to account for changes in the collectability assessment for operating leases. Other than operating lease receivables, Partnership trade receivables include receivables from finance leases and equipment sales. Under Topic 606 (Revenue from Contracts with Customers), revenue is recognized when, among other criteria, it is probable that the entity will collect the consideration to which it is entitled for goods or services transferred to a customer. At the point that finance lease receivables are recorded, they become subject to the CECL model and estimates of expected credit losses over their contractual life will be required to be recorded at inception based on historical information, current conditions, and reasonable and supportable forecasts. Trade receivables derived from equipment sales are of short duration and there is not a material difference between incurred losses and expected losses.

In April 2019, the FASB issued ASU 2019-04, Codification Improvements to Topic 326, Financial Instruments-Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments, which amends and clarifies several provisions of Topic 326. In May 2019, the FASB issued ASU 2019-05, Financial Instruments-Credit Losses (Topic 326): Targeted Transition Relief, which amends Topic 326 to allow the fair value option to be elected for certain financial instruments upon adoption. ASU 2019-10 extended the effective date of ASU 2016-13 until December 15, 2022. The Company adopted this new guidance, including the subsequent updates to Topic 326, on January 1, 2023 and the adoption did not have a material impact on the Company’s financial statements and related disclosures.

v3.23.2
Summary of Significant Accounting Policies (Tables)
6 Months Ended
Jun. 30, 2023
Summary of Significant Accounting Policies  
Schedule of anti-dilutive securities excluded from calculation

For the Three Months Ended

For the Six Months Ended

    

June 30,

 

June 30,

2023

2022

2023

2022

Common Stock Options

 

741,850

 

130,000

703,183

128,428

Restricted Stock Units

 

 

495,000

495,000

Convertible Preferred Stock

17,876,707

17,876,707

Common Stock Warrants

 

7,179,919

 

5,487,927

7,179,919

5,855,262

Total

 

25,798,476

 

6,112,927

25,759,809

6,478,690

v3.23.2
Stock Based Compensation (Tables)
6 Months Ended
Jun. 30, 2023
Stock Options  
Stock Based Compensation  
Summary of stock option activity under the stock option plans

    

    

    

Weighted-

    

Average

Aggregate

Weighted-

Remaining

Intrinsic

Number

Average

Contractual

Value

of

Exercise

Term

(in

Shares

Price

(Years)

millions)

Options outstanding at January 1, 2023

 

661,850

$

7.27

 

9.5

$

Options granted

 

80,000

$

0.87

 

10.0

 

Less options forfeited

 

$

 

 

Less options expired/cancelled

 

$

 

 

Less options exercised

 

$

 

 

Options outstanding at June 30, 2023

 

741,850

$

6.15

 

9.1

$

Options exercisable at June 30, 2023

 

661,850

$

6.08

 

9.0

$

v3.23.2
Common Stock Warrants (Tables)
6 Months Ended
Jun. 30, 2023
Common Stock Warrants  
Schedule of warrants outstanding

    

Number

of shares

Warrants outstanding January 1, 2022

 

6,265,525

Warrants issued

 

2,028,762

Warrants exercised

 

(65,000)

Warrants expired

(1,049,368)

Warrants outstanding and exercisable December 31, 2022 and June 30, 2023

 

7,179,919

v3.23.2
Fair Value Measurements (Tables)
6 Months Ended
Jun. 30, 2023
Fair Value Measurements  
Schedule of liabilities that are measured at fair value on a recurring basis

June 30,

December 31,

Description

    

Level

    

2023

    

2022

Liabilities:

 

  

 

  

 

  

Warrant liability (Note 6)

 

3

$

1,129,000

$

1,510,000

Bifurcated embedded derivative liability (Note 6)

 

3

$

2,628,000

$

370,300

Summary of the change in the fair value of the liabilities that is measured at fair value on a recurring basis

    

December 31, 2022

Balance on December 31, 2021

$

Issuance of warrants

 

9,915,000

Change in fair value of warrant liability

 

(8,405,000)

Balance on December 31, 2022

$

1,510,000

Change in fair value of warrant liability

 

(381,000)

Balance on June 30, 2023

$

1,129,000

    

December 31, 2022

Balance on December 31, 2021

$

Issuance of convertible preferred stock with bifurcated embedded derivative

 

2,191,300

Change in fair value of bifurcated embedded derivative

 

(1,821,900)

Balance on December 31, 2022

$

369,400

Change in fair value of warrant liability

 

2,258,600

Balance on June 30, 2023

$

2,628,000

v3.23.2
Organization, Business, Risks and Uncertainties: (Details)
Jun. 30, 2023
USD ($)
$ / shares
Apr. 24, 2023
D
$ / shares
Dec. 31, 2022
USD ($)
$ / shares
Organization, Business, Risks and Uncertainties      
Common stock, par value | $ / shares $ 0.0001   $ 0.0001
Cash and cash equivalents | $ $ 32,899,410   $ 37,478,480
Cash and cash equivalents expected amount at financial reporting date | $ $ 32,500,000    
Number of preceding consecutive business failed to maintain minimum closing bid price | D   30  
Minimum closing bid price failed to be maintained in the preceding 30 consecutive business days | $ / shares   $ 1.00  
Number of calendar days given as grace period to attain minimum bid price requirement | D   180  
Stock price to be maintained for minimum 10 consecutive business days in the grace period to achieve compliance | $ / shares   $ 1.00  
Number of minimum nonconsecutive business days in the grace period to maintain the bid price requirement to achieve compliance | D   10  
v3.23.2
Summary of Significant Accounting Policies: (Details) - USD ($)
6 Months Ended
Jul. 23, 2020
Jun. 30, 2023
Jun. 30, 2022
Dec. 31, 2022
Summary Of Significant Accounting Policies:        
Cash balance of insured FDIC amount   $ 2,200,000    
Cash balance of uninsured amount   $ 30,700,000    
Lease term   2 years    
Total future expense relating to the lease   $ 50,000    
Capitalized research and development services   0   $ 0
Net operating loss carryforwards   93,400,000    
Expense related to grants recognized   $ 0 $ 100,000  
Maximum        
Summary Of Significant Accounting Policies:        
Estimated useful life (years)   10 years    
Minimum        
Summary Of Significant Accounting Policies:        
Estimated useful life (years)   3 years    
National Institutes of Health | 2020 Services Agreement        
Summary Of Significant Accounting Policies:        
Amount of award received $ 2,700,000 $ 2,700,000    
v3.23.2
Summary of Significant Accounting Policies: - Anti-dilutive Securities (Details) - shares
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
Summary of Significant Accounting Policies        
Antidilutive securities 25,798,476 6,112,927 25,759,809 6,478,690
Common stock options        
Summary of Significant Accounting Policies        
Antidilutive securities 741,850 130,000 703,183 128,428
Restricted stock units        
Summary of Significant Accounting Policies        
Antidilutive securities   495,000   495,000
Convertible Preferred Stock        
Summary of Significant Accounting Policies        
Antidilutive securities 17,876,707   17,876,707  
Common stock warrants        
Summary of Significant Accounting Policies        
Antidilutive securities 7,179,919 5,487,927 7,179,919 5,855,262
v3.23.2
Summary of Significant Accounting Policies - Significant components of deferred tax assets and liabilities (Details)
$ in Millions
Jun. 30, 2023
USD ($)
Significant components of the Company's deferred tax assets and liabilities  
Net operating loss carryforward $ 27.4
v3.23.2
Collaborative Agreements and Commitments (Details)
6 Months Ended 12 Months Ended
Feb. 23, 2023
USD ($)
May 08, 2021
USD ($)
Jun. 09, 2020
USD ($)
Jan. 19, 2017
USD ($)
Jul. 14, 2014
USD ($)
May 12, 2014
USD ($)
Jun. 30, 2023
USD ($)
agreement
Dec. 31, 2022
agreement
Dec. 31, 2021
agreement
Collaborative Arrangement and Arrangement Other than Collaborative                  
Number of statements of work agreements entered | agreement             0 0 0
Stanford License Agreements                  
Collaborative Arrangement and Arrangement Other than Collaborative                  
Royalty payment percentage           3.00%      
Payments for royalties             $ 0    
Commitment to pay additional fee       $ 2,100,000          
Estimated cost             1,500,000    
Mt. Sinai License Agreement                  
Collaborative Arrangement and Arrangement Other than Collaborative                  
Milestone payments made             0    
Payments for royalties             0    
Additional milestone payments         $ 1,500,000        
Total amount paid         200,000        
Licensing fees         125,000        
Development costs and patent fees         75,000        
Payable of milestone payments         $ 2,000,000.0        
Mt. Sinai License Agreement | Net sales up to $250 million                  
Collaborative Arrangement and Arrangement Other than Collaborative                  
Royalty payment percentage         2.00%        
Threshold net sales         $ 250,000,000        
Mt. Sinai License Agreement | Net sales over $250 million                  
Collaborative Arrangement and Arrangement Other than Collaborative                  
Royalty payment percentage         3.00%        
Threshold net sales         $ 250,000,000        
Agreements with BryoLogyx                  
Collaborative Arrangement and Arrangement Other than Collaborative                  
Percentage of gross revenue     2.00%            
Other income             0    
Nemours Agreement                  
Collaborative Arrangement and Arrangement Other than Collaborative                  
Estimated cost   $ 2,000,000.0              
Cumulative expenses incurred             $ 100,000    
Cleveland Clinic                  
Collaborative Arrangement and Arrangement Other than Collaborative                  
Estimated cost $ 2,000,000.0                
License | Stanford License Agreements                  
Collaborative Arrangement and Arrangement Other than Collaborative                  
Aggregate amount paid       70,000          
Annual license maintenance fee       $ 10,000          
Minimum | Mt. Sinai License Agreement                  
Collaborative Arrangement and Arrangement Other than Collaborative                  
Royalty payment percentage       1.50%          
Maximum | Stanford License Agreements                  
Collaborative Arrangement and Arrangement Other than Collaborative                  
Royalty payment percentage       4.50%          
Milestone payments made           $ 3,700,000      
Maximum | Agreements with BryoLogyx                  
Collaborative Arrangement and Arrangement Other than Collaborative                  
Payments for royalties     $ 1,000,000            
v3.23.2
Related Party Transactions (Details) - Consulting Agreement with SM Capital Management, LLC - USD ($)
3 Months Ended 6 Months Ended
Aug. 04, 2016
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
Related Party Transaction          
Contract payments, term 1 year        
Annual consulting fee $ 120,000        
Monthly installment of annual consulting fee $ 10,000        
Consultancy fees   $ 30,000 $ 60,000 $ 30,000 $ 60,000
v3.23.2
Other Commitments (Details)
1 Months Ended 3 Months Ended 6 Months Ended 12 Months Ended
Aug. 04, 2022
May 12, 2022
item
Feb. 10, 2022
USD ($)
Jan. 01, 2022
USD ($)
Jul. 01, 2021
USD ($)
$ / shares
shares
Jan. 01, 2021
USD ($)
Dec. 07, 2020
USD ($)
Jul. 23, 2020
USD ($)
Aug. 04, 2016
USD ($)
Apr. 30, 2020
USD ($)
Jun. 30, 2023
USD ($)
Y
$ / shares
Jun. 30, 2022
USD ($)
Jun. 30, 2023
USD ($)
Y
$ / shares
shares
Jun. 30, 2022
USD ($)
Dec. 31, 2022
USD ($)
Jan. 22, 2022
USD ($)
Jan. 03, 2022
$ / shares
shares
Oct. 01, 2021
$ / shares
shares
Apr. 30, 2021
USD ($)
Apr. 01, 2021
$ / shares
shares
Feb. 16, 2021
$ / shares
shares
Other Commitments                                          
Clinical trial expenses                     $ 307,211 $ 1,941,101 $ 1,184,928 $ 3,427,175              
Exercise price of warrants | $ / shares                     $ 11.79   $ 11.79                
Number of options granted | shares                         80,000                
Options exercisable period                         9 years                
Volatility                                          
Other Commitments                                          
Warrants, measurement input                     1.118   1.118                
Risk-free interest rate                                          
Other Commitments                                          
Warrants, measurement input                     0.0238   0.0238                
Expected term                                          
Other Commitments                                          
Warrants, measurement input | Y                     5   5                
Dividend yield                                          
Other Commitments                                          
Warrants, measurement input                     0   0                
Consulting Agreement with Katalyst Securities LLC                                          
Other Commitments                                          
Monthly installment of annual consulting fee       $ 10,000   $ 20,000                              
Consultancy fees                     $ 0 30,000 $ 0 111,283              
Warrants to purchase shares of common stock | shares         4,500                       4,500 4,500   4,500 25,000
Exercise price of warrants | $ / shares         $ 9.76                       $ 8.69 $ 9.30   $ 8.80 $ 11.46
Consulting Agreement with Katalyst Securities LLC | Expected term                                          
Other Commitments                                          
Warrants, measurement input | Y                     5   5                
Consulting Agreement with Katalyst Securities LLC | Dividend yield                                          
Other Commitments                                          
Warrants, measurement input                     0   0                
Consulting Agreement with GP Nurmenkari, Inc                                          
Other Commitments                                          
Monthly installment of annual consulting fee       $ 10,000 $ 20,000 $ 12,000                              
Consultancy fees                     $ 0 30,000 $ 0 120,320              
Warrants to purchase shares of common stock | shares         5,800                       5,800 5,800   2,500 10,000
Warrants term following the effective date         3 months                                
Exercise price of warrants | $ / shares         $ 9.76                       $ 8.69 $ 9.30   $ 8.80 $ 11.46
Consulting Agreement with GP Nurmenkari, Inc | Expected term                                          
Other Commitments                                          
Warrants, measurement input | Y                     5   5                
Consulting Agreement with GP Nurmenkari, Inc | Dividend yield                                          
Other Commitments                                          
Warrants, measurement input                     0   0                
2020 Services Agreement                                          
Other Commitments                                          
Amount funded against the total trial cost     $ 1,000,000.0                         $ 1,400,000          
Total estimated budget for the services               $ 9,300,000     $ 11,000,000.0   $ 11,000,000.0                
Clinical trial expenses                     77,000 1,200,000 400,000 4,600,000              
WCT prepayments included as a prepaid expense and other current assets                     131,000   131,000                
WCT payments included in accounts payable                     171,000   171,000                
Charges Incurred     $ 0                                    
2020 Services Agreement | National Institutes of Health                                          
Other Commitments                                          
Total estimated budget for the services               $ 8,300,000                          
Threshold period of prior written notice to terminate agreement               60 days                          
Amount of award received               $ 2,700,000         2,700,000                
Funding received                   $ 1,000,000.0                      
Funding receivable in year two                                     $ 1,700,000    
Clinical trial expenses                         10,500,000                
2022 Services Agreement                                          
Other Commitments                                          
Target enrollment of study subjects | item   12                                      
Total estimated budget for the services                     2,000,000.0   2,000,000.0                
Clinical trial expenses                     33,000   157,000   $ 0            
WCT prepayments included as a prepaid expense and other current assets                     0   0                
WCT payments included in accounts payable                     55,000   55,000                
2022 Services Agreement | National Institutes of Health                                          
Other Commitments                                          
Clinical trial expenses                         1,600,000                
Employment agreement with Alan J. Tuchman, M.D                                          
Other Commitments                                          
Initial annual base salary             $ 222,000                            
Annual discretionary bonus payable (as a percent)             50.00%                            
Term of agreement             1 year                            
Extension periods of agreement             6 months                            
Additional extension period of agreement 6 months                                        
Consulting Agreement with SM Capital Management, LLC                                          
Other Commitments                                          
Contract payments, term                 1 year                        
Annual consulting fee                 $ 120,000                        
Monthly installment of annual consulting fee                 $ 10,000                        
Consultancy fees                     $ 30,000 $ 60,000 $ 30,000 $ 60,000              
v3.23.2
Other Commitments - Warrants Measurement Input and Fair Value (Details)
Jun. 30, 2023
Y
Dividend yield  
Other Commitments  
Warrants, measurement input 0
Volatility  
Other Commitments  
Warrants, measurement input 1.118
Risk-free interest rate  
Other Commitments  
Warrants, measurement input 0.0238
Expected term  
Other Commitments  
Warrants, measurement input 5
Consulting Agreement with Katalyst Securities LLC | Dividend yield  
Other Commitments  
Warrants, measurement input 0
Consulting Agreement with Katalyst Securities LLC | Expected term  
Other Commitments  
Warrants, measurement input 5
Consulting Agreement with GP Nurmenkari, Inc | Dividend yield  
Other Commitments  
Warrants, measurement input 0
Consulting Agreement with GP Nurmenkari, Inc | Expected term  
Other Commitments  
Warrants, measurement input 5
v3.23.2
Stockholders' Equity (Details)
6 Months Ended
Jun. 30, 2023
Vote
$ / shares
shares
Dec. 31, 2022
shares
Stockholders' Equity    
Common stock, shares authorized 150,000,000 150,000,000
Preferred stock, shares authorized 1,000,000  
Preferred stock, par value (in dollars per share) | $ / shares $ 0.0001  
Votes per share of common stock | Vote 1  
v3.23.2
Stockholders' Equity - Additional Information (Details)
3 Months Ended 6 Months Ended 12 Months Ended
Aug. 10, 2023
shares
Jul. 13, 2023
USD ($)
shares
May 11, 2023
Apr. 14, 2023
USD ($)
$ / shares
Nov. 17, 2022
USD ($)
$ / shares
Y
item
installment
D
shares
Jun. 30, 2023
USD ($)
Y
$ / shares
Jun. 30, 2022
USD ($)
$ / shares
shares
Jun. 30, 2023
USD ($)
Y
$ / shares
Jun. 30, 2022
USD ($)
$ / shares
shares
Dec. 31, 2022
USD ($)
$ / shares
Aug. 01, 2023
shares
Jul. 31, 2023
USD ($)
Jun. 01, 2023
USD ($)
Stockholders' Equity                          
Series B Preferred Stock, face value per share | $ / shares               $ 1,000   $ 1,000      
Warrants exercise price | $ / shares           $ 11.79   $ 11.79          
Fair value of warrants           $ 1,129,000   $ 1,129,000   $ 1,510,000      
Change in fair value of derivative liability           (2,484,400) $ 0 (2,258,600) $ 0        
Gain on change in fair value of the warrant liability           207,000   (381,000)          
Payment of temporary equity to satisfy first amortization payment due                         $ 1,640,000
Deferred cash payment           $ 1,140,000   $ 1,140,000       $ 953,000  
Cash payments elected to convert into commons stock   $ 2,160,000                      
Common stock shares issued | shares 2,799,249 3,125,907                      
Pre-amortization Common Stock to satisfy amortization payment | shares                     1,680,675    
Series E Warrants                          
Stockholders' Equity                          
Warrants to purchase shares of common stock | shares             50,000   50,000        
Warrants exercise price | $ / shares             $ 8.51   $ 8.51        
Series G Warrants                          
Stockholders' Equity                          
Warrants to purchase shares of common stock | shares             15,000   15,000        
Warrants exercise price | $ / shares             $ 8.51   $ 8.51        
Dividend yield                          
Stockholders' Equity                          
Warrants, measurement input           0   0          
Expected term                          
Stockholders' Equity                          
Warrants, measurement input | Y           5   5          
Volatility                          
Stockholders' Equity                          
Warrants, measurement input           1.118   1.118          
Risk-free interest rate                          
Stockholders' Equity                          
Warrants, measurement input           0.0238   0.0238          
Series B Preferred Stock                          
Stockholders' Equity                          
Percentage of changes in fair value convertible preferred stock       34.00%                  
Additional paid-in capital to accrete the preferred shares to redemption value                   2,455,656      
November 2022 Private Placement                          
Stockholders' Equity                          
Number of Series B Preferred Stock issued | shares         15,000                
Series B Preferred Stock, face value per share | $ / shares         $ 1,000                
Preferred shares issuable upon conversion of Series B Preferred Stock | shares         1,935,485                
Series B Preferred Stock, conversion price per share | $ / shares         $ 7.75                
Warrants to purchase shares of common stock | shares         1,935,485                
Number of equal monthly installments to redeem Series B Preferred Stock | installment         15                
Percentage of discount on average closing share prices considered for determination of amortization payments         15.00%                
Number of lowest closing share prices considered for determination of amortization payments | item         3                
Trading day period considered for determination of amortization payments         30 days                
Percentage of minimum price, considered for determination of amortization payments         20.00%                
Series B Preferred Stock, Stock price trigger for conversion | $ / shares         $ 11.625                
Series B Preferred Stock, Threshold Consecutive trading days considered for conversion | D         20                
Series B Preferred Stock, Daily trading volume of the Common Stock trigger for conversion | shares         100,000                
Series B Preferred Stock, dividend rate         7.00%                
Series B Preferred Stock, dividend rate during the continuance of a Triggering Event         15.00%                
Warrants exercise price | $ / shares         $ 7.75                
Term of warrants         5 years                
Issuance date fair value of the associated embedded derivative           $ 2,628,000   $ 2,628,000          
Bifurcated embedded derivative, measurement input | $ / shares           0.93   0.93          
Fair value of warrants           $ 1,129,000   $ 1,129,000   $ 9,900,000      
Warrant Issuance Costs               900,000          
Gain on change in fair value of the warrant liability           $ 207,000 $ 0 $ 381,000 $ 0        
November 2022 Private Placement | Minimum                          
Stockholders' Equity                          
Per share value of Common stock, considered for determination of amortization payments | $ / shares         $ 1.25                
November 2022 Private Placement | Maximum                          
Stockholders' Equity                          
Per share value of Common stock, considered for determination of amortization payments | $ / shares         0.172                
November 2022 Private Placement | Placement Agents                          
Stockholders' Equity                          
Warrants exercise price | $ / shares         $ 7.75                
Term of warrants         5 years                
Percentage of offering fees in cash         7.00%                
Percentage of offering fees in warrants         3.00%                
November 2022 Private Placement | Dividend yield                          
Stockholders' Equity                          
Bifurcated embedded derivative, measurement input           0.07   0.07          
Warrants, measurement input                   0      
November 2022 Private Placement | Expected term                          
Stockholders' Equity                          
Bifurcated embedded derivative, measurement input | Y           1.7   1.7          
Warrants, measurement input           4.38   4.38   5      
November 2022 Private Placement | Risk-free interest rate                          
Stockholders' Equity                          
Bifurcated embedded derivative, measurement input           0.065   0.065          
Warrants, measurement input           0.0424   0.0424   0.0397      
November 2022 Private Placement | Estimated equity volatility                          
Stockholders' Equity                          
Bifurcated embedded derivative, measurement input           1.45   1.45          
Warrants, measurement input           1.30   1.30   1.05      
November 2022 Private Placement | Estimated traded volume volatility                          
Stockholders' Equity                          
Bifurcated embedded derivative, measurement input           2.40   2.40          
November 2022 Private Placement | Penalty dividend rate                          
Stockholders' Equity                          
Bifurcated embedded derivative, measurement input           0.150   0.150          
November 2022 Private Placement | Probability of default                          
Stockholders' Equity                          
Bifurcated embedded derivative, measurement input           0.009   0.009          
Warrants, measurement input           0   0          
November 2022 Private Placement | Series B Preferred Stock                          
Stockholders' Equity                          
Percentage of common stock shares, agreed to register under the November registration rights agreement         200.00%                
Issuance date fair value of the associated embedded derivative                   $ 2,200,000      
Total discount upon issuance of Preferred Shares                   12,300,000      
Stock issuance costs                   500,000      
Fair value of warrants                   $ 9,600,000      
Percentage of preferred share floor price       20.00%                  
Percentage of changes in fair value convertible preferred stock     0.05%                    
Increase in fair value of deemed dividend on preferred stock       $ 5,700,000                  
November 2022 Private Placement | Series B Preferred Stock | Minimum                          
Stockholders' Equity                          
Floor price | $ / shares       $ 1.25                  
November 2022 Private Placement | Series B Preferred Stock | Maximum                          
Stockholders' Equity                          
Percentage of changes in fair value convertible preferred stock     10.00% 10.00%                  
November 2022 Private Placement | Series B Preferred Stock | Dividend yield                          
Stockholders' Equity                          
Bifurcated embedded derivative, measurement input         0.07                
November 2022 Private Placement | Series B Preferred Stock | Expected term                          
Stockholders' Equity                          
Bifurcated embedded derivative, measurement input | Y         1.61                
November 2022 Private Placement | Series B Preferred Stock | Risk-free interest rate                          
Stockholders' Equity                          
Bifurcated embedded derivative, measurement input         0.073                
November 2022 Private Placement | Series B Preferred Stock | Fair value of our common stock                          
Stockholders' Equity                          
Bifurcated embedded derivative, measurement input | $ / shares         6.52                
November 2022 Private Placement | Series B Preferred Stock | Estimated equity volatility                          
Stockholders' Equity                          
Bifurcated embedded derivative, measurement input         0.850                
November 2022 Private Placement | Series B Preferred Stock | Estimated traded volume volatility                          
Stockholders' Equity                          
Bifurcated embedded derivative, measurement input         2.550                
November 2022 Private Placement | Series B Preferred Stock | Penalty dividend rate                          
Stockholders' Equity                          
Bifurcated embedded derivative, measurement input         0.150                
November 2022 Private Placement | Series B Preferred Stock | Probability of default                          
Stockholders' Equity                          
Bifurcated embedded derivative, measurement input         0.082                
November 2022 Private Placement | Preferred Stock | Series B Preferred Stock                          
Stockholders' Equity                          
Issuance date fair value of the associated embedded derivative         $ 2,200,000                
v3.23.2
Stock Based Compensation (Details)
1 Months Ended 3 Months Ended 6 Months Ended 12 Months Ended
Jun. 07, 2023
USD ($)
shares
Mar. 29, 2023
USD ($)
item
$ / shares
shares
Mar. 22, 2023
USD ($)
shares
Jan. 05, 2023
USD ($)
shares
Dec. 31, 2022
USD ($)
$ / shares
Dec. 07, 2022
USD ($)
shares
Nov. 30, 2022
USD ($)
director
$ / shares
shares
Nov. 15, 2022
USD ($)
item
$ / shares
shares
Oct. 08, 2022
USD ($)
$ / shares
shares
Sep. 15, 2022
Sep. 08, 2022
USD ($)
shares
Jul. 08, 2022
USD ($)
$ / shares
shares
Jun. 07, 2022
USD ($)
shares
Mar. 14, 2022
USD ($)
shares
Feb. 16, 2022
$ / shares
shares
Feb. 15, 2022
USD ($)
shares
Jul. 13, 2021
USD ($)
director
employee
shares
Nov. 30, 2022
USD ($)
$ / shares
shares
Jun. 30, 2023
USD ($)
$ / shares
Jun. 30, 2022
USD ($)
Jun. 30, 2023
USD ($)
$ / shares
shares
Jun. 30, 2022
USD ($)
Dec. 31, 2022
USD ($)
$ / shares
shares
Oct. 11, 2022
shares
Apr. 07, 2021
shares
Dec. 07, 2020
shares
Stock Based Compensation                                                    
Stock option grant authorized for service on a committee of the Board of Directors                                               625,000 625,000  
Closing stock price | $ / shares         $ 1.16                           $ 0.923   $ 0.923   $ 1.16      
Unrecognized compensation costs | $                                     $ 45,000   $ 45,000          
Total unrecognized compensation costs expected to be recognized over a weighted average period                                         9 months          
Number of options granted                                         80,000          
Exercise price | $ / shares                                         $ 0.87          
Fair value of stock options | $         $ 0                           0   $ 0   $ 0      
Stock options expense | $                                     $ 334,416 $ 11,544 $ 979,207 $ 47,918        
Number of awards exercised                                         65,000          
Warrants exercise price | $ / shares                                     $ 11.79   $ 11.79          
Volatility                                                    
Stock Based Compensation                                                    
Warrants, measurement input                                     1.118   1.118          
Risk-free interest rate                                                    
Stock Based Compensation                                                    
Warrants, measurement input                                     0.0238   0.0238          
Board members, officers and employees                                                    
Stock Based Compensation                                                    
Number of options granted   80,000                                                
Exercise price | $ / shares   $ 0.87                                                
Volatility   123.92%                                                
Risk-free interest rate   3.66%                                                
Vesting period   1 year                                                
Number of board members to whom stock options were granted | item   4                                                
Expiration period   10 years                                                
Fair value of stock options | $   $ 59,763                                                
Equity Incentive Plan 2020                                                    
Stock Based Compensation                                                    
Stock option grant authorized for service on a committee of the Board of Directors                                               1,375,000 250,000 250,000
Volatility                                         112.75%          
Risk-free interest rate                                         2.05%          
Fair value portion of warrants | $                                     $ 42,108   $ 42,108          
Vesting period                                         1 year          
Stock options expense | $                                     334,416 1,016,690 $ 979,197 1,728,248        
Equity Incentive Plan 2020 | Research And Development                                                    
Stock Based Compensation                                                    
Stock options expense | $                                     49,863 172,601 149,589 293,651        
Equity Incentive Plan 2020 | General And Administrative                                                    
Stock Based Compensation                                                    
Stock options expense | $                                     284,553 844,089 829,608 1,434,597        
Equity Incentive Plan 2020 | Chief Executive Officer                                                    
Stock Based Compensation                                                    
Number of options granted                             6,150                      
Exercise price | $ / shares                             $ 7.29                      
Expected term                             10 years                      
Equity Incentive Plan 2020 | Board members, officers and employees                                                    
Stock Based Compensation                                                    
Number of options granted               531,850                                    
Exercise price | $ / shares               $ 6.07                                    
Volatility               107.05%                                    
Risk-free interest rate               3.93%                                    
Vesting period               6 months                                    
Number of board members to whom stock options were granted | item               6                                    
Number of officers to whom stock options were granted | item               2                                    
Number of employees to whom stock options were granted | item               2                                    
Expiration period               10 years                                    
Vesting percentage               50.00%                                    
Fair value of stock options | $               $ 2,570,328                                    
Percentage of expensing at the date of issuance               50.00%                                    
Percentage of expensing over the vesting period               50.00%                                    
Unvested restricted stock units                                                    
Stock Based Compensation                                                    
Stock option grant authorized for service on a committee of the Board of Directors                                 495,000                  
Stock options expense | $                                       $ 1,005,146 0 $ 1,680,330        
Number of director | director                                 7                  
Number of executive directors | director                                 2                  
Number of directors who forfeited the award | director             1                                      
Number of officers who forfeited the award | director             1                                      
Number of awards forfeited             86,000                                      
Reversal of allocated share-based compensation expense | $                                 $ 370,000                  
Percentage of awards vested and exercised                                             100.00%      
Number of awards vested                                             411,000      
Number of awards exercised                                             411,000      
Total unrecognized compensation costs | $         $ 2,560,000                           $ 0   $ 0   $ 2,560,000      
Grant date fair value of RSU's issued (per share) | $ / shares                                         $ 9.75          
Grant date fair value of RSU's issued | $                                         $ 4,800,000          
Restricted Stock                                                    
Stock Based Compensation                                                    
Volatility                 112.75%             112.75%                    
Risk-free interest rate                 4.14%             3.05%                    
Fair value portion of warrants | $                 $ 25,000             $ 75,000                    
Number of shares granted                 6,878   540 30,303 679 692   13,775                    
Fair market value of shares issued | $                 $ 50,000   $ 4,500 $ 150,000 $ 4,500 $ 4,500   $ 91,429                    
Warrants to purchase shares of common stock                 4,659     15,459                            
Warrants exercise price | $ / shares                 $ 14.54     $ 13.26                            
Warrants term                 5 years     5 years                            
Non employee directors | Director Compensation Policy                                                    
Stock Based Compensation                                                    
Number of securities available for grant   20,000                                                
Non employee directors | Unvested restricted stock units                                                    
Stock Based Compensation                                                    
Number of shares granted                                 425,000                  
Newly appointed director | Director Compensation Policy                                                    
Stock Based Compensation                                                    
Vesting percentage   50.00%                                                
Number of securities available for grant   20,000                                                
Employee | Unvested restricted stock units                                                    
Stock Based Compensation                                                    
Number of shares granted                                 10,000                  
Entity number of employees | employee                                 2                  
CFO | Unvested restricted stock units                                                    
Stock Based Compensation                                                    
Number of shares granted                                 60,000                  
Consulting Agreement With Sherwood Ventures LLC | Restricted Stock                                                    
Stock Based Compensation                                                    
Number of shares granted 5,409   4,500 88,339   893                                        
Fair market value of shares issued | $ $ 4,500   $ 4,500 $ 100,000   $ 4,501                                        
Warrants to purchase shares of common stock             4,795                     4,795                
Warrants exercise price | $ / shares             $ 14.10                     $ 14.10                
Number of restricted shares issued                                   7,092                
Amount of restricted shares issued | $                                   $ 50,000                
Fair value of issuance | $             $ 25,000                     $ 25,000                
Consulting Agreement With Sherwood Ventures LLC | Restricted Stock | Volatility                                                    
Stock Based Compensation                                                    
Warrants, measurement input             1.1275                     1.1275                
Consulting Agreement With Sherwood Ventures LLC | Restricted Stock | Risk-free interest rate                                                    
Stock Based Compensation                                                    
Warrants, measurement input             0.0439                     0.0439                
First anniversary from Start Date | Unvested restricted stock units                                                    
Stock Based Compensation                                                    
Vesting percentage                   100.00%                                
First anniversary from Start Date | Newly appointed director | Director Compensation Policy                                                    
Stock Based Compensation                                                    
Vesting percentage   25.00%                                                
Second anniversary from Start Date | Unvested restricted stock units                                                    
Stock Based Compensation                                                    
Vesting percentage         100.00%                                          
Second anniversary from Start Date | Newly appointed director | Director Compensation Policy                                                    
Stock Based Compensation                                                    
Vesting percentage   25.00%                                                
v3.23.2
Stock Based Compensation - Stock option activity under the stock option plans (Details) - USD ($)
$ / shares in Units, $ in Millions
6 Months Ended 12 Months Ended
Jun. 30, 2023
Dec. 31, 2022
Number of Shares    
Options outstanding at the beginning 661,850  
Options granted 80,000  
Options outstanding at the end 741,850 661,850
Options exercisable at the end 661,850  
Weighted-Average Exercise Price    
Options outstanding at the beginning (in dollars per share) $ 7.27  
Options granted (in dollars per share) 0.87  
Options outstanding at the end (in dollars per share) 6.15 $ 7.27
Options exercisable at the end (in dollars per share) $ 6.08  
Weighted-Average Remaining Contractual Term (Years)    
Options granted (in years) 10 years  
Options outstanding at the end (in years) 9 years 1 month 6 days 9 years 6 months
Options exercisable at the end (in years) 9 years  
Aggregate Intrinsic Value    
Options outstanding at the beginning (in dollars) $ 0  
Options outstanding at the end (in dollars) 0 $ 0
Options exercisable at the end (in dollars) $ 0  
v3.23.2
Common Stock Warrants - Common stock warrant outstanding (Details)
6 Months Ended
Jun. 30, 2023
shares
Common Stock Warrants  
Warrants outstanding January 1 6,265,525
Warrants issued 2,028,762
Warrants expired (1,049,368)
Warrants exercised (65,000)
Warrants outstanding December 31 7,179,919
v3.23.2
Common Stock Warrants - Additional Information (Details)
1 Months Ended 3 Months Ended 6 Months Ended
Jun. 30, 2023
USD ($)
Y
$ / shares
Nov. 30, 2022
USD ($)
Jun. 30, 2023
USD ($)
Y
item
$ / shares
Jun. 30, 2022
USD ($)
$ / shares
shares
Jun. 30, 2023
USD ($)
Y
item
$ / shares
Jun. 30, 2022
USD ($)
item
$ / shares
shares
Dec. 31, 2022
USD ($)
Nov. 22, 2022
$ / shares
shares
Jan. 03, 2022
$ / shares
shares
Common Stock Warrants                  
Warrants to purchase shares of common stock | $ / shares $ 0.928   $ 0.928   $ 0.928        
Warrants exercise price | $ / shares $ 11.79   $ 11.79   $ 11.79        
Change in fair value of warrant liability     $ 207,000   $ (381,000)        
Warrant liability $ 1,129,000   1,129,000   1,129,000   $ 1,510,000    
Weighted average remaining life of warrants 3 years 2 months 1 day                
Intrinsic value of the warrants $ 134,800   $ 134,800   $ 134,800        
Number of warrant holders who exercised their warrants     0 0 0        
Proceeds from warrant exercises           $ 553,150      
Warrant [Member]                  
Common Stock Warrants                  
Proceeds from warrant exercises           $ 553,150      
Series E Warrants                  
Common Stock Warrants                  
Warrants to purchase shares of common stock | shares       50,000   50,000      
Warrants exercise price | $ / shares       $ 8.51   $ 8.51      
Number of warrant holders who exercised their warrants | item           3      
Warrants outstanding | shares       50,000   50,000      
Series G Warrants                  
Common Stock Warrants                  
Warrants to purchase shares of common stock | shares       15,000   15,000      
Warrants exercise price | $ / shares       $ 8.51   $ 8.51      
Number of warrant holders who exercised their warrants | item           1      
Warrants outstanding | shares       15,000   15,000      
Dividend yield                  
Common Stock Warrants                  
Warrants, measurement input 0   0   0        
Expected term                  
Common Stock Warrants                  
Warrants, measurement input | Y 5   5   5        
Volatility                  
Common Stock Warrants                  
Warrants, measurement input 1.118   1.118   1.118        
Risk-free interest rate                  
Common Stock Warrants                  
Warrants, measurement input 0.0238   0.0238   0.0238        
Advisory Agreements                  
Common Stock Warrants                  
Warrants to purchase shares of common stock | shares               1,993,485 10,300
Warrants exercise price | $ / shares               $ 7.75 $ 8.96
Warrants term               5 years 5 years
Change in fair value of warrant liability   $ 9,600,000 $ 0   $ 71,603        
Warrant liability $ 1,129,000   $ 1,129,000   $ 1,129,000        
Advisory Agreements | Dividend yield                  
Common Stock Warrants                  
Warrants, measurement input               0  
Advisory Agreements | Volatility                  
Common Stock Warrants                  
Warrants, measurement input               1.05  
Advisory Agreements | Risk-free interest rate                  
Common Stock Warrants                  
Warrants, measurement input               0.0397  
v3.23.2
Fair Value Measurements (Details) - Recurring - Fair Value, Inputs, Level 3 - USD ($)
Jun. 30, 2023
Dec. 31, 2022
Warrant liability    
Fair Value Measurements    
Liabilities, fair value $ 1,129,000 $ 1,510,000
Bifurcated embedded derivative liability    
Fair Value Measurements    
Liabilities, fair value $ 2,628,000 $ 370,300
v3.23.2
Fair Value Measurements - Change in the fair value (Details) - USD ($)
6 Months Ended 12 Months Ended
Jun. 30, 2023
Dec. 31, 2022
Warrant liability    
Change in the fair value of the liability    
Beginning balance $ 1,510,000  
Issuance   $ 9,915,000
Change in fair value of warrant liability (381,000) (8,405,000)
Ending balance 1,129,000 1,510,000
Bifurcated embedded derivative liability    
Change in the fair value of the liability    
Beginning balance 369,400  
Issuance   2,191,300
Change in fair value of warrant liability 2,258,600 (1,821,900)
Ending balance $ 2,628,000 $ 369,400

Synaptogenix (NASDAQ:SNPX)
Historical Stock Chart
From Mar 2024 to Apr 2024 Click Here for more Synaptogenix Charts.
Synaptogenix (NASDAQ:SNPX)
Historical Stock Chart
From Apr 2023 to Apr 2024 Click Here for more Synaptogenix Charts.