false Q3 --12-31 0001799011 0001799011 2024-01-01 2024-09-30 0001799011 2024-09-30 0001799011 2024-11-08 0001799011 2023-12-31 0001799011 us-gaap:SeriesBPreferredStockMember 2024-09-30 0001799011 LUCD:SeriesBOnePreferredStockMember 2024-09-30 0001799011 us-gaap:SeriesAPreferredStockMember 2023-12-31 0001799011 LUCD:SeriesAOnePreferredStockMember 2023-12-31 0001799011 2024-07-01 2024-09-30 0001799011 2023-07-01 2023-09-30 0001799011 2023-01-01 2023-09-30 0001799011 us-gaap:PreferredStockMember 2024-06-30 0001799011 us-gaap:CommonStockMember 2024-06-30 0001799011 us-gaap:AdditionalPaidInCapitalMember 2024-06-30 0001799011 us-gaap:RetainedEarningsMember 2024-06-30 0001799011 2024-06-30 0001799011 us-gaap:PreferredStockMember 2023-12-31 0001799011 us-gaap:CommonStockMember 2023-12-31 0001799011 us-gaap:AdditionalPaidInCapitalMember 2023-12-31 0001799011 us-gaap:RetainedEarningsMember 2023-12-31 0001799011 us-gaap:PreferredStockMember 2023-06-30 0001799011 us-gaap:CommonStockMember 2023-06-30 0001799011 us-gaap:AdditionalPaidInCapitalMember 2023-06-30 0001799011 us-gaap:RetainedEarningsMember 2023-06-30 0001799011 2023-06-30 0001799011 us-gaap:PreferredStockMember 2022-12-31 0001799011 us-gaap:CommonStockMember 2022-12-31 0001799011 us-gaap:AdditionalPaidInCapitalMember 2022-12-31 0001799011 us-gaap:RetainedEarningsMember 2022-12-31 0001799011 2022-12-31 0001799011 us-gaap:PreferredStockMember 2024-07-01 2024-09-30 0001799011 us-gaap:CommonStockMember 2024-07-01 2024-09-30 0001799011 us-gaap:AdditionalPaidInCapitalMember 2024-07-01 2024-09-30 0001799011 us-gaap:RetainedEarningsMember 2024-07-01 2024-09-30 0001799011 us-gaap:PreferredStockMember 2024-01-01 2024-09-30 0001799011 us-gaap:CommonStockMember 2024-01-01 2024-09-30 0001799011 us-gaap:AdditionalPaidInCapitalMember 2024-01-01 2024-09-30 0001799011 us-gaap:RetainedEarningsMember 2024-01-01 2024-09-30 0001799011 us-gaap:PreferredStockMember 2023-07-01 2023-09-30 0001799011 us-gaap:CommonStockMember 2023-07-01 2023-09-30 0001799011 us-gaap:AdditionalPaidInCapitalMember 2023-07-01 2023-09-30 0001799011 us-gaap:RetainedEarningsMember 2023-07-01 2023-09-30 0001799011 us-gaap:PreferredStockMember 2023-01-01 2023-09-30 0001799011 us-gaap:CommonStockMember 2023-01-01 2023-09-30 0001799011 us-gaap:AdditionalPaidInCapitalMember 2023-01-01 2023-09-30 0001799011 us-gaap:RetainedEarningsMember 2023-01-01 2023-09-30 0001799011 us-gaap:PreferredStockMember 2024-09-30 0001799011 us-gaap:CommonStockMember 2024-09-30 0001799011 us-gaap:AdditionalPaidInCapitalMember 2024-09-30 0001799011 us-gaap:RetainedEarningsMember 2024-09-30 0001799011 us-gaap:PreferredStockMember 2023-09-30 0001799011 us-gaap:CommonStockMember 2023-09-30 0001799011 us-gaap:AdditionalPaidInCapitalMember 2023-09-30 0001799011 us-gaap:RetainedEarningsMember 2023-09-30 0001799011 2023-09-30 0001799011 LUCD:MSAFeesMember 2023-12-31 0001799011 LUCD:ERCPayrollBenefitsMember 2023-12-31 0001799011 LUCD:OBOPaymentsMember 2023-12-31 0001799011 LUCD:MSAFeesMember 2024-01-01 2024-09-30 0001799011 LUCD:ERCPayrollBenefitsMember 2024-01-01 2024-09-30 0001799011 LUCD:OBOPaymentsMember 2024-01-01 2024-09-30 0001799011 LUCD:MSAFeesMember 2024-09-30 0001799011 LUCD:ERCPayrollBenefitsMember 2024-09-30 0001799011 LUCD:OBOPaymentsMember 2024-09-30 0001799011 LUCD:PavmedIncMember srt:MinimumMember 2023-01-01 2023-09-30 0001799011 LUCD:PavmedIncMember srt:MaximumMember 2023-01-01 2023-09-30 0001799011 LUCD:PavmedIncMember 2023-01-01 2023-09-30 0001799011 LUCD:PavmedIncMember 2024-07-01 2024-09-30 0001799011 LUCD:ManagementServicesAgreementMember 2024-01-26 2024-01-26 0001799011 LUCD:PavmedIncMember 2024-01-26 2024-01-26 0001799011 2024-09-27 2024-09-27 0001799011 LUCD:PavmedIncMember LUCD:ManagementServicesAgreementMember us-gaap:SellingAndMarketingExpenseMember 2024-07-01 2024-09-30 0001799011 LUCD:PavmedIncMember LUCD:ManagementServicesAgreementMember us-gaap:SellingAndMarketingExpenseMember 2023-07-01 2023-09-30 0001799011 LUCD:PavmedIncMember LUCD:ManagementServicesAgreementMember us-gaap:SellingAndMarketingExpenseMember 2024-01-01 2024-09-30 0001799011 LUCD:PavmedIncMember LUCD:ManagementServicesAgreementMember us-gaap:SellingAndMarketingExpenseMember 2023-01-01 2023-09-30 0001799011 LUCD:PavmedIncMember LUCD:ManagementServicesAgreementMember us-gaap:GeneralAndAdministrativeExpenseMember 2024-07-01 2024-09-30 0001799011 LUCD:PavmedIncMember LUCD:ManagementServicesAgreementMember us-gaap:GeneralAndAdministrativeExpenseMember 2023-07-01 2023-09-30 0001799011 LUCD:PavmedIncMember LUCD:ManagementServicesAgreementMember us-gaap:GeneralAndAdministrativeExpenseMember 2024-01-01 2024-09-30 0001799011 LUCD:PavmedIncMember LUCD:ManagementServicesAgreementMember us-gaap:GeneralAndAdministrativeExpenseMember 2023-01-01 2023-09-30 0001799011 LUCD:PavmedIncMember LUCD:ManagementServicesAgreementMember us-gaap:ResearchAndDevelopmentExpenseMember 2024-07-01 2024-09-30 0001799011 LUCD:PavmedIncMember LUCD:ManagementServicesAgreementMember us-gaap:ResearchAndDevelopmentExpenseMember 2023-07-01 2023-09-30 0001799011 LUCD:PavmedIncMember LUCD:ManagementServicesAgreementMember us-gaap:ResearchAndDevelopmentExpenseMember 2024-01-01 2024-09-30 0001799011 LUCD:PavmedIncMember LUCD:ManagementServicesAgreementMember us-gaap:ResearchAndDevelopmentExpenseMember 2023-01-01 2023-09-30 0001799011 LUCD:PavmedIncMember LUCD:ManagementServicesAgreementMember 2024-07-01 2024-09-30 0001799011 LUCD:PavmedIncMember LUCD:ManagementServicesAgreementMember 2023-07-01 2023-09-30 0001799011 LUCD:PavmedIncMember LUCD:ManagementServicesAgreementMember 2024-01-01 2024-09-30 0001799011 LUCD:PavmedIncMember LUCD:ManagementServicesAgreementMember 2023-01-01 2023-09-30 0001799011 LUCD:DefensiveTechnologyMember 2024-09-30 0001799011 LUCD:DefensiveTechnologyMember 2023-12-31 0001799011 LUCD:LaboratoryInformationManagementSoftwareMember 2024-09-30 0001799011 LUCD:LaboratoryInformationManagementSoftwareMember 2023-12-31 0001799011 LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember us-gaap:FairValueInputsLevel1Member 2024-09-30 0001799011 LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember us-gaap:FairValueInputsLevel2Member 2024-09-30 0001799011 LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember us-gaap:FairValueInputsLevel3Member 2024-09-30 0001799011 LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember 2024-09-30 0001799011 us-gaap:FairValueInputsLevel1Member 2024-09-30 0001799011 us-gaap:FairValueInputsLevel2Member 2024-09-30 0001799011 us-gaap:FairValueInputsLevel3Member 2024-09-30 0001799011 LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember us-gaap:FairValueInputsLevel1Member 2023-12-31 0001799011 LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember us-gaap:FairValueInputsLevel2Member 2023-12-31 0001799011 LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember us-gaap:FairValueInputsLevel3Member 2023-12-31 0001799011 LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember 2023-12-31 0001799011 us-gaap:FairValueInputsLevel1Member 2023-12-31 0001799011 us-gaap:FairValueInputsLevel2Member 2023-12-31 0001799011 us-gaap:FairValueInputsLevel3Member 2023-12-31 0001799011 LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember 2023-03-21 0001799011 LUCD:MeasurementInputRequiredRateOfReturnMember LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember 2024-09-30 0001799011 LUCD:MeasurementInputRequiredRateOfReturnMember LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember 2023-12-31 0001799011 us-gaap:MeasurementInputConversionPriceMember LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember 2024-09-30 0001799011 us-gaap:MeasurementInputConversionPriceMember LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember 2023-12-31 0001799011 us-gaap:MeasurementInputSharePriceMember LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember 2024-09-30 0001799011 us-gaap:MeasurementInputSharePriceMember LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember 2023-12-31 0001799011 LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember us-gaap:MeasurementInputExpectedTermMember 2024-01-01 2024-09-30 0001799011 LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember us-gaap:MeasurementInputExpectedTermMember 2023-01-01 2023-12-31 0001799011 LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember us-gaap:MeasurementInputPriceVolatilityMember 2024-09-30 0001799011 LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember us-gaap:MeasurementInputPriceVolatilityMember 2023-12-31 0001799011 LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember us-gaap:MeasurementInputRiskFreeInterestRateMember 2024-09-30 0001799011 LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember us-gaap:MeasurementInputRiskFreeInterestRateMember 2023-12-31 0001799011 LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember us-gaap:MeasurementInputExpectedDividendRateMember 2024-09-30 0001799011 LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember us-gaap:MeasurementInputExpectedDividendRateMember 2023-12-31 0001799011 LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember 2024-01-01 2024-09-30 0001799011 LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember 2023-01-01 2023-12-31 0001799011 LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember 2024-06-30 0001799011 us-gaap:OtherOperatingIncomeExpenseMember 2024-06-30 0001799011 LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember 2024-07-01 2024-09-30 0001799011 us-gaap:OtherOperatingIncomeExpenseMember 2024-07-01 2024-09-30 0001799011 us-gaap:OtherOperatingIncomeExpenseMember 2024-09-30 0001799011 us-gaap:OtherOperatingIncomeExpenseMember 2023-12-31 0001799011 us-gaap:OtherOperatingIncomeExpenseMember 2024-01-01 2024-09-30 0001799011 LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember 2023-06-30 0001799011 us-gaap:OtherOperatingIncomeExpenseMember 2023-06-30 0001799011 LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember 2023-07-01 2023-09-30 0001799011 us-gaap:OtherOperatingIncomeExpenseMember 2023-07-01 2023-09-30 0001799011 LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember 2023-09-30 0001799011 us-gaap:OtherOperatingIncomeExpenseMember 2023-09-30 0001799011 LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember 2022-12-31 0001799011 us-gaap:OtherOperatingIncomeExpenseMember 2022-12-31 0001799011 LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember 2023-01-01 2023-09-30 0001799011 us-gaap:OtherOperatingIncomeExpenseMember 2023-01-01 2023-09-30 0001799011 LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember 2023-03-13 0001799011 LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember 2023-03-21 2023-03-21 0001799011 LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember 2023-09-21 2023-09-21 0001799011 2023-03-01 2023-03-31 0001799011 2023-03-31 0001799011 us-gaap:SubsequentEventMember LUCD:MarchTwoThousandAndTwentyThreeSeniorSecuredConvertibleNoteMember 2024-11-08 2024-11-08 0001799011 LUCD:NovemberTwoThousandTwentyFourSeniorConvertibleNotesMember us-gaap:SubsequentEventMember 2024-11-08 0001799011 us-gaap:SubsequentEventMember LUCD:November2024SeniorConvertibleNotesMember 2024-10-01 2024-11-12 0001799011 LUCD:TwoThousandEighteenLongTermIncentiveEquityPlanMember 2024-09-30 0001799011 LUCD:OutsideOfTwoThousandEighteenPlanMember 2024-01-01 2024-09-30 0001799011 us-gaap:RestrictedStockMember LUCD:OutsideOfTwoThousandEighteenPlanMember 2024-01-01 2024-09-30 0001799011 LUCD:TwoThousandEighteenLongTermIncentiveEquityPlanMember 2024-01-31 0001799011 LUCD:EmployeesMember 2024-02-22 2024-02-22 0001799011 LUCD:EmployeesMember 2024-02-22 0001799011 us-gaap:RestrictedStockMember LUCD:TwoThousandEighteenEquityPlanMember 2024-05-01 2024-05-31 0001799011 LUCD:TwoThousandEighteenLongTermIncentiveEquityPlanMember us-gaap:EmployeeStockOptionMember 2024-01-01 2024-09-30 0001799011 LUCD:TwoThousandEighteenLongTermIncentiveEquityPlanMember us-gaap:EmployeeStockOptionMember 2023-01-01 2023-09-30 0001799011 LUCD:EmployeeStockPurchasePlanMember 2024-01-01 2024-03-31 0001799011 LUCD:EmployeeStockPurchasePlanMember 2023-01-01 2023-03-31 0001799011 LUCD:EmployeeStockPurchasePlanMember 2024-07-01 2024-09-30 0001799011 LUCD:EmployeeStockPurchasePlanMember 2023-07-01 2023-09-30 0001799011 LUCD:EmployeeStockPurchasePlanMember 2024-09-30 0001799011 LUCD:EmployeeStockPurchasePlanMember 2024-01-01 2024-01-31 0001799011 2023-01-01 2023-12-31 0001799011 LUCD:OutsideOfTwoThousandEighteenPlanMember 2023-01-01 2023-12-31 0001799011 us-gaap:RestrictedStockMember 2023-12-31 0001799011 us-gaap:RestrictedStockMember 2024-01-01 2024-09-30 0001799011 us-gaap:RestrictedStockMember 2024-09-30 0001799011 LUCD:TwoThousandEighteenLongTermIncentiveEquityPlanMember LUCD:CostOfRevenueMember 2024-07-01 2024-09-30 0001799011 LUCD:TwoThousandEighteenLongTermIncentiveEquityPlanMember LUCD:CostOfRevenueMember 2023-07-01 2023-09-30 0001799011 LUCD:TwoThousandEighteenLongTermIncentiveEquityPlanMember LUCD:CostOfRevenueMember 2024-01-01 2024-09-30 0001799011 LUCD:TwoThousandEighteenLongTermIncentiveEquityPlanMember LUCD:CostOfRevenueMember 2023-01-01 2023-09-30 0001799011 LUCD:TwoThousandEighteenLongTermIncentiveEquityPlanMember us-gaap:SellingAndMarketingExpenseMember 2024-07-01 2024-09-30 0001799011 LUCD:TwoThousandEighteenLongTermIncentiveEquityPlanMember us-gaap:SellingAndMarketingExpenseMember 2023-07-01 2023-09-30 0001799011 LUCD:TwoThousandEighteenLongTermIncentiveEquityPlanMember us-gaap:SellingAndMarketingExpenseMember 2024-01-01 2024-09-30 0001799011 LUCD:TwoThousandEighteenLongTermIncentiveEquityPlanMember us-gaap:SellingAndMarketingExpenseMember 2023-01-01 2023-09-30 0001799011 LUCD:TwoThousandEighteenLongTermIncentiveEquityPlanMember us-gaap:GeneralAndAdministrativeExpenseMember 2024-07-01 2024-09-30 0001799011 LUCD:TwoThousandEighteenLongTermIncentiveEquityPlanMember us-gaap:GeneralAndAdministrativeExpenseMember 2023-07-01 2023-09-30 0001799011 LUCD:TwoThousandEighteenLongTermIncentiveEquityPlanMember us-gaap:GeneralAndAdministrativeExpenseMember 2024-01-01 2024-09-30 0001799011 LUCD:TwoThousandEighteenLongTermIncentiveEquityPlanMember us-gaap:GeneralAndAdministrativeExpenseMember 2023-01-01 2023-09-30 0001799011 LUCD:TwoThousandEighteenLongTermIncentiveEquityPlanMember us-gaap:ResearchAndDevelopmentExpenseMember 2024-07-01 2024-09-30 0001799011 LUCD:TwoThousandEighteenLongTermIncentiveEquityPlanMember us-gaap:ResearchAndDevelopmentExpenseMember 2023-07-01 2023-09-30 0001799011 LUCD:TwoThousandEighteenLongTermIncentiveEquityPlanMember us-gaap:ResearchAndDevelopmentExpenseMember 2024-01-01 2024-09-30 0001799011 LUCD:TwoThousandEighteenLongTermIncentiveEquityPlanMember us-gaap:ResearchAndDevelopmentExpenseMember 2023-01-01 2023-09-30 0001799011 LUCD:PAVmedIncTwoThousandFourteenEquityPlanMember LUCD:CostOfRevenueMember 2024-07-01 2024-09-30 0001799011 LUCD:PAVmedIncTwoThousandFourteenEquityPlanMember LUCD:CostOfRevenueMember 2023-07-01 2023-09-30 0001799011 LUCD:PAVmedIncTwoThousandFourteenEquityPlanMember LUCD:CostOfRevenueMember 2024-01-01 2024-09-30 0001799011 LUCD:PAVmedIncTwoThousandFourteenEquityPlanMember LUCD:CostOfRevenueMember 2023-01-01 2023-09-30 0001799011 LUCD:PAVmedIncTwoThousandFourteenEquityPlanMember us-gaap:SellingAndMarketingExpenseMember 2024-07-01 2024-09-30 0001799011 LUCD:PAVmedIncTwoThousandFourteenEquityPlanMember us-gaap:SellingAndMarketingExpenseMember 2023-07-01 2023-09-30 0001799011 LUCD:PAVmedIncTwoThousandFourteenEquityPlanMember us-gaap:SellingAndMarketingExpenseMember 2024-01-01 2024-09-30 0001799011 LUCD:PAVmedIncTwoThousandFourteenEquityPlanMember us-gaap:SellingAndMarketingExpenseMember 2023-01-01 2023-09-30 0001799011 LUCD:PAVmedIncTwoThousandFourteenEquityPlanMember us-gaap:GeneralAndAdministrativeExpenseMember 2024-07-01 2024-09-30 0001799011 LUCD:PAVmedIncTwoThousandFourteenEquityPlanMember us-gaap:GeneralAndAdministrativeExpenseMember 2023-07-01 2023-09-30 0001799011 LUCD:PAVmedIncTwoThousandFourteenEquityPlanMember us-gaap:GeneralAndAdministrativeExpenseMember 2024-01-01 2024-09-30 0001799011 LUCD:PAVmedIncTwoThousandFourteenEquityPlanMember us-gaap:GeneralAndAdministrativeExpenseMember 2023-01-01 2023-09-30 0001799011 LUCD:PAVmedIncTwoThousandFourteenEquityPlanMember us-gaap:ResearchAndDevelopmentExpenseMember 2024-07-01 2024-09-30 0001799011 LUCD:PAVmedIncTwoThousandFourteenEquityPlanMember us-gaap:ResearchAndDevelopmentExpenseMember 2023-07-01 2023-09-30 0001799011 LUCD:PAVmedIncTwoThousandFourteenEquityPlanMember us-gaap:ResearchAndDevelopmentExpenseMember 2024-01-01 2024-09-30 0001799011 LUCD:PAVmedIncTwoThousandFourteenEquityPlanMember us-gaap:ResearchAndDevelopmentExpenseMember 2023-01-01 2023-09-30 0001799011 us-gaap:EmployeeStockOptionMember LUCD:TwoThousandEighteenLongTermIncentiveEquityPlanMember 2024-09-30 0001799011 us-gaap:RestrictedStockMember LUCD:TwoThousandEighteenLongTermIncentiveEquityPlanMember 2024-09-30 0001799011 us-gaap:RestrictedStockMember LUCD:TwoThousandEighteenLongTermIncentiveEquityPlanMember 2024-01-01 2024-09-30 0001799011 us-gaap:EmployeeStockOptionMember LUCD:PAVmedIncTwoThousandFourteenEquityPlanMember 2024-09-30 0001799011 us-gaap:EmployeeStockOptionMember LUCD:PAVmedIncTwoThousandFourteenEquityPlanMember 2024-01-01 2024-09-30 0001799011 LUCD:TwoThousandEighteenLongTermIncentiveEquityPlanMember 2024-01-01 2024-09-30 0001799011 LUCD:TwoThousandEighteenLongTermIncentiveEquityPlanMember 2023-01-01 2023-09-30 0001799011 LUCD:SeriesBOnePreferredStockMember 2024-03-13 2024-03-13 0001799011 us-gaap:SeriesBPreferredStockMember 2024-03-13 0001799011 us-gaap:SeriesAPreferredStockMember 2024-03-13 2024-03-13 0001799011 us-gaap:SeriesAPreferredStockMember 2024-03-13 0001799011 LUCD:SeriesAOnePreferredStockMember 2024-03-13 2024-03-13 0001799011 LUCD:SeriesAOnePreferredStockMember 2024-03-13 0001799011 us-gaap:SeriesBPreferredStockMember 2024-03-13 2024-03-13 0001799011 LUCD:SeriesAOnePreferredStockMember us-gaap:InvestorMember 2024-03-13 2024-03-13 0001799011 LUCD:SeriesAOnePreferredStockMember us-gaap:InvestorMember 2024-03-13 0001799011 us-gaap:CommonStockMember srt:MinimumMember 2024-03-13 0001799011 LUCD:SeriesBOnePreferredStockMember 2024-05-06 0001799011 LUCD:SeriesBOnePreferredStockMember 2024-05-05 2024-05-06 0001799011 us-gaap:SeriesAPreferredStockMember 2023-03-07 0001799011 us-gaap:SeriesAPreferredStockMember 2023-03-07 2023-03-07 0001799011 LUCD:SeriesAOnePreferredStockMember 2023-10-17 0001799011 LUCD:SeriesAOnePreferredStockMember 2023-10-17 2023-10-17 0001799011 LUCD:SeriesBConvertiblePreferredStockMember 2024-01-01 2024-09-30 0001799011 LUCD:SeriesAAndAOneConvertiblePreferredStockMember 2024-03-13 2024-03-13 0001799011 LUCD:SeriesAAndAOneConvertiblePreferredStockMember 2024-03-13 0001799011 us-gaap:CommonStockMember 2024-07-01 2024-07-31 0001799011 LUCD:PavmedIncMember 2024-09-30 0001799011 LUCD:CantorFitzgeraldMember LUCD:CommitedEquityFacilityMember 2022-03-28 0001799011 LUCD:CantorFitzgeraldMember LUCD:CommitedEquityFacilityMember 2024-09-30 0001799011 LUCD:CommitedEquityFacilityMember LUCD:CantorFitzgeraldMember 2024-01-01 2024-09-30 0001799011 LUCD:ControlledEquityOfferingAgreementMember LUCD:CantorFitzgeraldMember 2022-11-30 0001799011 LUCD:ControlledEquityOfferingAgreementMember LUCD:CantorFitzgeraldMember 2024-09-30 0001799011 LUCD:ControlledEquityOfferingAgreementMember LUCD:CantorFitzgeraldMember 2024-01-01 2024-09-30 0001799011 2024-03-13 2024-03-13 0001799011 us-gaap:EmployeeStockOptionMember 2024-01-01 2024-09-30 0001799011 us-gaap:EmployeeStockOptionMember 2023-01-01 2023-09-30 0001799011 LUCD:UnvestedRestrictedStockAwardsMember 2024-01-01 2024-09-30 0001799011 LUCD:UnvestedRestrictedStockAwardsMember 2023-01-01 2023-09-30 0001799011 us-gaap:PreferredStockMember 2024-01-01 2024-09-30 0001799011 us-gaap:PreferredStockMember 2023-01-01 2023-09-30 iso4217:USD xbrli:shares iso4217:USD xbrli:shares xbrli:pure

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

FORM 10-Q

 

(Mark One)

 

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

 

For the quarterly period ended September 30, 2024

 

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: 001-40901

 

LUCID DIAGNOSTICS INC.

(Exact Name of Registrant as Specified in Its Charter)

 

Delaware   82-5488042
(State or Other Jurisdiction of   (IRS Employer
Incorporation or Organization)   Identification No.)
     
360 Madison Avenue    
25th Floor    
New York, NY   10017
(Address of Principal Executive Offices)   (Zip Code)

 

(917) 813-1828

(Registrant’s Telephone Number, Including Area Code)

 

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

 

Title of each Class   Trading Symbol(s)   Name of each Exchange on which Registered
Common Stock, $0.001 par value per share   LUCD   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 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 filed
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(c) 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 September 30, 2024 and November 8, 2024 there were 55,495,158 and 59,342,479, respectively, shares of the registrant’s Common Stock, par value $0.001 per share, issued and outstanding (with such number of shares inclusive of shares of common stock underlying unvested restricted stock awards granted under the Lucid Diagnostics Inc. 2018 Long-Term Incentive Equity Plan as of such date).

 

 

 

 
 

 

TABLE OF CONTENTS

 

  Part I - Financial Information Page
     
Item 1. Financial Statements  
  Condensed Consolidated Balance Sheets (unaudited) as of September 30, 2024 and December 31, 2023 1
  Condensed Consolidated Statements of Operations (unaudited) for the three and nine months ended September 30, 2024 and 2023 2
  Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficit) (unaudited) for the three and nine months ended September 30, 2024 and 2023 3
  Condensed Consolidated Statements of Cash Flows (unaudited) for the nine months ended September 30, 2024 and 2023 5
  Notes to Unaudited Condensed Consolidated Financial Statements 6
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 24
Item 4. Controls and Procedures 34
     
  Part II - Other Information  
     
Item 1. Legal Proceedings 35
Item 5. Other Information 35
Item 6. Exhibits 35
  Signature 36
  Exhibit Index 37

 

i
 

 

Part I - Financial Information

 

Item 1. Financial Statements

 

LUCID DIAGNOSTICS INC.

and SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands except number of shares and per share data - unaudited)

 

   September 30, 2024   December 31, 2023 
Assets:          
Current assets:          
Cash  $14,489   $18,896 
Accounts receivable   39    45 
Inventory   651    278 
Prepaid expenses, deposits, and other current assets   1,645    2,854 
Total current assets   16,824    22,073 
Fixed assets, net   940    1,334 
Operating lease right-of-use assets   2,860    1,307 
Intangible assets, net   842    1,424 
Other assets   1,132    1,132 
Total assets  $22,598   $27,270 
Liabilities, Preferred Stock and Stockholders’ Equity (Deficit)          
Current liabilities:          
Accounts payable  $1,135   $1,146 
Accrued expenses and other current liabilities   2,006    3,841 
Operating lease liabilities, current portion   855    1,106 
Senior Secured Convertible Note - at fair value   10,200    13,950 
Due To: PAVmed Inc. - MSA Fee and operating expenses   53    9,339 
Total current liabilities   14,249    29,382 
Operating lease liabilities, less current portion   2,011    199 
Total liabilities   16,260    29,581 
Commitments and contingencies   -    - 
Stockholders’ Equity:          
Preferred stock, $0.001 par value, 20,000,000 shares authorized; Series B and Series B-1 Convertible Preferred Stock, issued and outstanding 55,919 at September 30, 2024 and Series A and Series A-1 Convertible Preferred Stock, shares issued and outstanding 18,625 at December 31, 2023   55,919    18,625 
Common stock, $0.001 par value, 300,000,000 and 200,000,000 shares authorized as of September 30, 2024 and December 31, 2023, respectively; 51,597,718 and 42,329,864 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively   52    42 
Additional paid-in capital   142,592    129,763 
Accumulated deficit   (192,225)   (150,741)
Total Stockholders’ Equity (Deficit)   6,338    (2,311)
Total Liabilities and Stockholders’ Equity (Deficit)  $22,598   $27,270 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

1
 

 

LUCID DIAGNOSTICS INC.

and SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands except number of shares and per share data - unaudited)

 

   2024   2023   2024   2023 
  

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

 
   2024   2023   2024   2023 
Revenue  $1,172   $783   $3,149   $1,388 
Operating expenses:                    
Cost of revenue   1,684    1,634    4,954    4,522 
Sales and marketing   4,056    3,837    12,459    11,996 
General and administrative   5,355    4,320    14,292    15,049 
Amortization of acquired intangible assets   105    505    582    1,516 
Research and development   1,666    1,615    4,539    5,334 
Total operating expenses   12,866    11,911    36,826    38,417 
Operating loss   (11,694)   (11,128)   (33,677)   (37,029)
Other income (expense):                    
Interest income   81    116    256    330 
Interest expense   (1)   (149)   (19)   (405)
Change in fair value - Senior Secured Convertible Note   (322)   (3,021)   568    (3,520)
Loss on issue and offering costs - Senior Secured Convertible Note               (1,186)
Debt extinguishments loss - Senior Secured Convertible Note   (435)   (26)   (1,116)   (26)
Other income (expense), net   (677)   (3,080)   (311)   (4,807)
Loss before provision for income tax   (12,371)   (14,208)   (33,988)   (41,836)
Provision for income taxes                
Net loss attributable to Lucid Diagnostics Inc.  $(12,371)  $(14,208)  $(33,988)  $(41,836)
Less: Deemed dividend on Series A and Series A-1 Convertible Preferred Stock           (7,496)    
Net loss attributable to Lucid Diagnostics Inc. common stockholders  $(12,371)  $(14,208)  $(41,484)  $(41,836)
Net loss per share attributable to Lucid Diagnostics Inc. common stockholders - basic and diluted  $(0.25)  $(0.34)  $(0.87)  $(1.01)
Weighted average common shares outstanding, basic and diluted   50,374,146    41,862,805    47,876,015    41,558,979 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

2
 

 

LUCID DIAGNOSTICS INC.

and SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)

for the THREE AND NINE MONTHS ENDED September 30, 2024

(in thousands except number of shares and per share data - unaudited)

 

   Shares   Amount   Shares   Amount   Additional Paid-In Capital   Accumulated Deficit   Total 
   Preferred Stock   Common Stock             
   Shares   Amount   Shares   Amount   Additional Paid-In Capital   Accumulated Deficit   Total 
Balance as of June 30, 2024   55,919    55,919    49,344,945   $49   $139,865   $(179,854)  $15,979 
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan                   1,185        1,185 
Stock-based compensation - PAVmed Inc. 2014 Equity Plan                   43        43 
Conversions - Senior Secured Convertible Note           2,116,717    3    1,755        1,758 
Purchase - Employee Stock Purchase Plan           136,056        94        94 
Transfer of intellectual property from PAVmed Inc.   

    

    

    

    

(350

)       

(350

)
Net loss                       (12,371)   (12,371)
Balance as of September 30, 2024   55,919   $55,919    51,597,718   $52   $142,592   $(192,225)  $6,338 

 

   Shares   Amount   Shares   Amount   Additional Paid-In Capital   Accumulated Deficit   Total 
   Preferred Stock   Common Stock             
   Shares   Amount   Shares   Amount   Additional Paid-In Capital   Accumulated Deficit   Total 
Balance as of December 31, 2023   18,625   $18,625    42,329,864   $42   $129,763   $(150,741)  $(2,311)
Exercise - stock options - Lucid Diagnostics Inc. 2018 Equity Plan           3,333        4        4 
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan                   3,034        3,034 
Stock-based compensation - PAVmed Inc. 2014 Equity Plan                   329        329 
Vest - restricted stock awards           26,912                 
Conversions - Senior Secured Convertible Note           4,777,898    6    4,293        4,299 
Purchase - Employee Stock Purchase Plan           647,940    1    446        447 
Issuance - Series A-1 Preferred Stock   5,670    5,670                    5,670 
Exchange - Series A and Series A-1 Preferred Stock   (24,295)   (24,295)               (7,496)   (31,791)
Issuance through exchange - Series B and Series B-1 Preferred Stock   31,790    31,790                    31,790 
Issuance through sale- Series B and Series B-1 Preferred Stock   

24,129

    

24,129

    

    

    

    

    24,129 
Issuance - Due To: PAVmed Inc. Settlement in Common Stock           3,331,771    3    4,672        4,675 
Issue common stock - vendor service agreement           480,000         401        401 
Transfer of intellectual property from PAVmed Inc.   

    

    

    

    

(350

)   

    (350)
Net loss                       (33,988)   (33,988)
Balance as of September 30, 2024   55,919   $55,919    51,597,718   $52   $142,592   $(192,225)  $6,338 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

3
 

 

LUCID DIAGNOSTICS INC.

and SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)

for the THREE AND NINE MONTHS ENDED September 30, 2023

(in thousands except number of shares and per share data - unaudited)

 

   Shares   Amount   Shares   Amount   Additional Paid-In Capital   Accumulated Deficit   Total 
   Preferred Stock   Common Stock             
   Shares   Amount   Shares   Amount   Additional Paid-In Capital   Accumulated Deficit   Total 
Balance as of June 30, 2023   13,625    13,625    41,853,603   $42   $127,107   $(125,703)  $15,071 
Exercise - stock options - Lucid Diagnostics Inc. 2018 Equity Plan                            
Stock-based compensation - Lucid Diagnostics Inc.                   1,032        1,032 
Stock-based compensation - PAVmed Inc.                   220        220 
Vest - restricted stock awards           84,660                 
Conversions - Senior Secured Convertible Note           115,388        166        166 
CapNostics, LLC                            
APA-RDx - Installment Payment                            
Issuance - Committed Equity Facility, net of deferred financing charges                            
Purchase - Employee Stock Purchase Plan           276,213        275        275 
Issue common stock - vendor service agreement                            
Net loss                       (14,208)   (14,208)
Balance as of September 30, 2023   13,625   $13,625    42,329,864   $42   $128,800   $(139,911)  $2,556 

 

   Shares   Amount   Shares   Amount   Additional Paid-In Capital   Accumulated Deficit   Total 
   Preferred Stock   Common Stock             
   Shares   Amount   Shares   Amount   Additional Paid-In Capital   Accumulated Deficit   Total 
Balance as of December 31, 2022      $    40,518,792   $41   $121,081   $(98,075)  $23,047 
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan                   5,014        5,014 
Stock-based compensation - PAVmed Inc. 2014 Equity Plan                   845        845 
Vest - restricted stock awards           303,980                 
Conversions - Senior Secured Convertible Note           115,388        166        166 
Issuance common stock - APA-RDx - Termination payment           553,436        713        713 
Issuance - At-The-Market Facility, net of financing charges           230,068    1    283        284 
Purchase - Employee Stock Purchase Plan           508,200        551        551 
Issuance - Series A Preferred Stock   13,625    13,625                    13,625 
Issue common stock - vendor service agreement           100,000        147        147 
Net loss                       (41,836)   (41,836)
Balance as of September 30, 2023   13,625   $13,625    42,329,864   $42   $128,800   $(139,911)  $2,556 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

4
 

 

LUCID DIAGNOSTICS INC.

and SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands except number of shares and per share data - unaudited)

 

   2024   2023 
   Nine Months Ended September 30, 
   2024   2023 
Cash flows from operating activities          
Net loss  $(33,988)  $(41,836)
           
Adjustments to reconcile net loss to net cash used in operating activities          
Depreciation and amortization expense   945    1,870 
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan   3,034    5,014 
Stock-based compensation - PAVmed Inc. 2014 Equity Plan   329    845 
Change in fair value - Senior Secured Convertible Note   (568)   3,520 
Loss on issue - Senior Secured Convertible Note       1,111 
Debt extinguishment loss - Senior Secured Convertible Note   1,116    26 
APA-RDx: Issue common stock - termination payment       713 
Amortization of common stock payment for vendor service agreement   248    23 
Changes in operating assets and liabilities:          
Accounts receivable   7    (4)
Prepaid expenses and other current assets   1,065    (1,262)
Accounts payable   (10)   (62)
Accrued expenses and other current liabilities   (1,836)   1,878 
Due To: PAVmed Inc. - operating expenses, employee related costs, MSA Fee   (4,611)   5,326 
Net cash flows used in operating activities   (34,269)   (22,838)
           
Cash flows from investing activities          
Purchase of equipment   (37)   (46)
Purchase of intellectual property from PAVmed Inc.   (350)    
Net cash flows used in investing activities   (387)   (46)
           
Cash flows from financing activities          
Proceeds – issue of preferred stock   29,798    13,625 
Proceeds – issue of Senior Convertible Note       10,000 
Proceeds – issue of common stock – At-The-Market Facility       284 
Proceeds – exercise of stock options   4     
Proceeds – issue common stock – Employee Stock Purchase Plan   447    551 
Net cash flows provided by financing activities   30,249    24,460 
           
Net increase (decrease) in cash   (4,407)   1,576 
Cash, beginning of period   18,896    22,474 
Cash, end of period  $14,489   $24,050 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

5
 

 

LUCID DIAGNOSTICS INC.

and SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(amounts in these accompanying notes are presented in thousands, except number of shares and per-share amounts.)

 

Note 1 — The Company

 

Description of the Business

 

Lucid Diagnostics Inc. (“Lucid”, “Lucid Diagnostics” or the “Company”) is a commercial-stage, cancer prevention medical diagnostics technology company focused on the millions of patients with gastroesophageal reflux disease (“GERD”), also known as chronic heartburn, acid reflux or simply reflux, who are at risk of developing esophageal precancer and cancer, specifically highly lethal esophageal adenocarcinoma (“EAC”). Lucid is a non-consolidated subsidiary of PAVmed Inc. (“PAVmed”).

 

The Company believes that its flagship product, the EsoGuard Esophageal DNA Test, performed on samples collected with the EsoCheck Esophageal Cell Collection Device, constitutes the first and only commercially available diagnostic test capable of serving as a widespread testing tool for the early detection of esophageal precancer in at-risk GERD patients.

 

EsoGuard is a bisulfite-converted next-generation sequencing (NGS) DNA assay performed on surface esophageal cells collected with EsoCheck. Cell samples, including those collected with EsoCheck, as discussed below, are sent to our laboratory, for testing and analyses using our proprietary EsoGuard NGS DNA assay.

 

EsoCheck is a FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells in a less than a five-minute office procedure. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from which a soft silicone balloon with textured ridges emerges, when inflated, to gently swab surface esophageal cells. When vacuum suction is applied, the balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted region during device withdrawal. The Company believes that this proprietary Collect+Protect™ technology makes EsoCheck the only noninvasive esophageal cell collection device capable of such anatomically targeted and protected sampling.

 

EsoGuard and EsoCheck are based on patented technology licensed by Lucid from Case Western Reserve University (“CWRU”). EsoGuard and EsoCheck have been developed to provide an accurate, non-invasive, patient-friendly test for the early detection of EAC and Barrett’s Esophagus (“BE”), including dysplastic BE and related precursors to EAC in patients with chronic GERD.

 

Note 2 — Liquidity and Going Concern

 

The Company’s management is required to assess an entity’s ability to continue as a going concern within one year of the date of the financial statements being issued. In each reporting period, including interim periods, an entity is required to assess conditions known and reasonably knowable as of the financial statement issuance date to determine whether it is probable an entity will not meet its financial obligations within one year from the financial statement issuance date. Substantial doubt about an entity’s ability to continue as a going concern exists when conditions and events, considered in the aggregate, indicate it is probable the entity will be unable to meet its financial obligations as they become due within one year after the date the financial statements are issued.

 

The Company has financed its operations principally through public and private issuances of its common stock, preferred stock, and debt. The Company is subject to all of the risks and uncertainties typically faced by medical device and diagnostic companies that devote substantially all of their efforts to the commercialization of their initial product and services and ongoing research and development activities and conducting clinical trials. The Company generated $1.2 million and $3.1 million of revenues for the three and nine month periods ended September 30, 2024, respectively, however the Company expects to continue to experience recurring losses and to generate negative cash flows from operating activities in the near future.

 

The Company incurred a net loss attributable to Lucid Diagnostics Inc common stockholders of approximately $41.5 million and had net cash flows used in operating activities of approximately $34.3 million for the nine month period ended September 30, 2024. As of September 30, 2024, the Company had working capital of approximately $2.6 million, with such working capital inclusive of the Senior Secured Convertible Note classified as a current liability of approximately $10.2 million and approximately $14.5 million of cash.

 

The Company’s ability to continue operations 12 months beyond the issuance of the financial statements, will depend upon generating substantial revenue that is conditioned upon obtaining positive third-party reimbursement coverage for its EsoGuard Esophageal DNA Test from both government and private health insurance providers, increasing revenue through contracting directly with self-insured employers, and on its ability to raise additional capital through various potential sources including equity and/or debt financings or refinancing existing debt obligations. These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the accompanying unaudited condensed consolidated financial statements are issued.

 

6
 

 

Note 3 — Summary of Significant Accounting Policies

 

Significant Accounting Policies

 

The Company’s significant accounting policies are as disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 as filed with the SEC on March 25, 2024, except as otherwise noted herein below.

 

Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements of the Company and its subsidiaries have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”), and applicable rules and regulations of the United States Securities and Exchange Commission (“SEC”), and include the accounts of the Company and its wholly-owned subsidiaries. All intercompany transactions and balances have been eliminated in consolidation. The Company is a non-consolidated subsidiary of PAVmed, which has the ability to exercise significant influence over the Company. The Company manages its operations as a single operating segment for the purposes of assessing performance and making operating decisions.

 

As permitted under SEC rules, certain footnotes or other financial information normally required by U.S. GAAP have been condensed or omitted. The balance sheet as of December 31, 2023 has been derived from audited consolidated financial statements at such date. The accompanying unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements, and in the opinion of management, include all adjustments, consisting only of routine recurring adjustments, necessary for a fair statement of the Company’s unaudited condensed consolidated financial information.

 

The unaudited condensed consolidated results of operations for the three and nine months ended September 30, 2024 are not necessarily indicative of the consolidated results to be expected for the year ending December 31, 2024 or for any other interim period or for any other future periods. The accompanying unaudited condensed consolidated financial statements and related unaudited condensed consolidated financial information should be read in conjunction with the Company’s audited consolidated financial statements and related notes thereto as of and for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K as filed with the SEC on March 25, 2024.

 

All amounts in the accompanying unaudited condensed consolidated financial statements and the notes thereto are presented in thousands of dollars, if not otherwise noted as being presented in millions of dollars, except for shares and per share amounts.

 

Use of Estimates

 

In preparing the unaudited condensed consolidated financial statements in conformity with U.S. GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and the determination of corresponding carrying value reserves, if any, and liabilities and the disclosure of contingent losses, as of the date of the unaudited condensed consolidated financial statements, as well as the reported amounts of revenue and expenses during the reporting period. Significant estimates in these unaudited condensed consolidated financial statements include those related to the estimated fair value of debt obligations, stock-based equity awards and intangible assets. Other significant estimates include the estimated incremental borrowing rate, the provision or benefit for income taxes and the corresponding valuation allowance on deferred tax assets. Additionally, management’s assessment of the Company’s ability to continue as a going concern involves the estimation of the amount and timing of future cash inflows and outflows. On an ongoing basis, the Company evaluates its estimates and assumptions. The Company bases its estimates on historical experience and on various other assumptions believed to be reasonable. Due to inherent uncertainty involved in making estimates, actual results reported in future periods may be affected by changes in these estimates.

 

Revenue Recognition

 

Revenues are recognized when the satisfaction of the performance obligation occurs, in an amount that reflects the consideration the Company expects to collect in exchange for those services. The Company’s revenue is primarily generated by its laboratory testing services utilizing its EsoGuard Esophageal DNA tests. The services are completed upon release of a patient’s test result to the ordering healthcare provider. Revenue recognized is inclusive of both variable consideration in connection with an individual patient’s third-party insurance coverage policy and fixed consideration in connection with a contracted services arrangement with an unrelated third party legal entity. To determine revenue recognition for the arrangements that the Company determines are within the scope of ASC 606, Revenue from Contracts with Customers, the Company performs the following five steps: (1) identify the contract(s) with a customer, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract and (5) recognize revenue when (or as) the entity satisfies a performance obligation.

 

7
 

 

Note 3 — Summary of Significant Accounting Policies - continued

 

The key aspects considered by the Company include the following:

 

Contracts—The Company’s customer is primarily the patient, but the Company does not enter into a formal reimbursement contract with a patient. The Company establishes a contract with a patient in accordance with other customary business practices, which is the point in time an order is received from a provider and a patient specimen has been returned to the laboratory for testing. Payment terms are a function of a patient’s existing insurance benefits, including the impact of coverage decisions with Center for Medicare & Medicaid Services (“CMS”) and applicable reimbursement contracts established between the Company and payers. However, when a patient is considered self-pay, the Company requires payment from the patient prior to the commencement of the Company’s performance obligations. The Company’s consideration can be deemed variable or fixed depending on the structure of specific payer contracts, and the Company considers collection of such consideration to be probable to the extent that it is unconstrained.

 

Performance obligations—A performance obligation is a promise in a contract to transfer a distinct good or service (or a bundle of goods or services) to the customer. The Company’s contracts have a single performance obligation, which is satisfied upon rendering of services, which culminates in the release of a patient’s test result to the ordering healthcare provider. The Company elects the practical expedient related to the disclosure of unsatisfied performance obligations, as the duration of time between providing testing supplies, the receipt of a sample, and the release of a test result to the ordering healthcare provider is far less than one year.

 

Transaction price—The transaction price is the amount of consideration that the Company expects to collect in exchange for transferring promised goods or services to a customer, excluding amounts collected on behalf of third parties (for example, some sales taxes). The consideration expected to be collected from a contract with a customer may include fixed amounts, variable amounts, or both.

 

If the consideration derived from the contracts is deemed to be variable, the Company estimates the amount of consideration to which it will be entitled in exchange for the promised goods or services. The Company limits the amount of variable consideration included in the transaction price to the unconstrained portion of such consideration. In other words, the Company recognizes revenue up to the amount of variable consideration that is not subject to a significant reversal until additional information is obtained or the uncertainty associated with the additional payments or refunds is subsequently resolved.

 

When the Company does not have significant historical experience or that experience has limited predictive value, the constraint over estimates of variable consideration may result in no revenue being recognized upon delivery of patient EsoGuard test results to the ordering healthcare provider. As such, the Company recognizes revenue up to the amount of variable consideration not subject to a significant reversal until additional information is obtained or the uncertainty associated with additional payments or refunds, if any, is subsequently resolved. Differences between original estimates and subsequent revisions, including final settlements, represent changes in estimated expected variable consideration, with the change in estimate recognized in the period of such revised estimate. With respect to a contracted service arrangement, the fixed consideration revenue is recognized on an as-billed basis upon delivery of the laboratory test report with realization of such fixed consideration deemed probable based upon actual historical experience.

 

Allocate transaction price—The transaction price is allocated entirely to the performance obligation contained within the contract with a customer on the basis of the relative standalone selling prices of each distinct good or service.

 

Practical Expedients—The Company does not adjust the transaction price for the effects of a significant financing component, as at contract inception, the Company expects the collection cycle to be one year or less.

 

Fair Value Option (“FVO”) Election

 

Under a Securities Purchase Agreement dated March 13, 2023, the Company issued a Senior Secured Convertible Note dated March 21, 2023, referred to herein as the “March 2023 Senior Convertible Note”, which is accounted under the “fair value option election” as discussed below.

 

Under Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 815, Derivative and Hedging, (“ASC 815”), a financial instrument containing embedded features and/or options may be required to be bifurcated from the financial instrument host and recognized as separate derivative asset or liability, with the bifurcated derivative asset or liability initially measured at estimated fair value as of the transaction issue date and then subsequently remeasured at estimated fair value as of each reporting period balance sheet date.

 

Alternatively, FASB ASC Topic 825, Financial Instruments, (“ASC 825”) provides for the “fair value option” (“FVO”) election. In this regard, ASC 825-10-15-4 provides for the FVO election (to the extent not otherwise prohibited by ASC 825-10-15-5) to be afforded to financial instruments, wherein the financial instrument is initially measured at estimated fair value as of the transaction issue date and then subsequently remeasured at estimated fair value as of each reporting period balance sheet date, with changes in the estimated fair value recognized as other income (expense) in the statement of operations. The estimated fair value adjustment of the March 2023 Senior Convertible Note, including the component related to accrued interest, is presented in a single line item within other income (expense) in the accompanying unaudited condensed consolidated statement of operations (as provided for by ASC 825-10-50-30(b)). Further, as required by ASC 825-10-45-5, to the extent a portion of the fair value adjustment is attributed to a change in the instrument-specific credit risk, such portion would be recognized as a component of other comprehensive income (“OCI”) (for which there was no such adjustment with respect to the March 2023 Senior Convertible Note).

 

See Note 9, Financial Instruments Fair Value Measurements, with respect to the FVO election; and Note 10, Debt, for a discussion of the March 2023 Senior Convertible Note.

 

8
 

 

Note 3 — Summary of Significant Accounting Policies - continued

 

Recent Accounting Standards Updates Not Yet Adopted

 

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740)—Improvements to Income Tax Disclosures (“ASU 2023-09”), which is intended to enhance the transparency and decision usefulness of income tax disclosures. The amendments in ASU 2023-09 provide for enhanced income tax information primarily through changes to the rate reconciliation and income taxes paid information. ASU 2023-09 is effective for the Company prospectively to all annual periods beginning after December 15, 2024. Early adoption is permitted. The Company does not expect the standard to have a significant impact on its unaudited condensed consolidated financial statements.

 

In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280)—Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which require public companies disclose significant segment expenses and other segment items on an annual and interim basis and to provide in interim periods all disclosures about a reportable segment’s profit or loss and assets that are currently required annually. The guidance is effective for public entities for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. The guidance is applied retrospectively to all periods presented in the financial statements, unless it is impracticable. The Company is currently evaluating the impact this update will have on its unaudited condensed consolidated financial statements and disclosures, however the company does not expect the standard to have a significant impact.

 

In October 2023, the FASB issued ASU No. 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative. This update modifies the disclosure or presentation requirements of a variety of topics in the Accounting Standards Codification to conform with certain SEC amendments in Release No. 33-10532, Disclosure Update and Simplification. The amendments in this update should be applied prospectively, and the effective date for each amendment will be the date on which the SEC’s removal of that related disclosure from Regulation S-X or S-K becomes effective. However, if the SEC has not removed the related disclosure from its regulations by June 30, 2027, the amendments will be removed from the Codification and not become effective. Early adoption is prohibited. The Company is currently evaluating the impact this update will have on its unaudited condensed consolidated financial statements and disclosures.

 

Note 4 — Revenue from Contracts with Customers

 

Revenue Recognized

 

In the three and nine month periods ended September 30, 2024, the Company recognized revenue of $1,172 and $3,149, respectively, resulting from the delivery of patient EsoGuard test results. Revenue recognized from customer contracts deemed to include a variable consideration transaction price is limited to the unconstrained portion of the variable consideration. The Company’s revenue for the three and nine month periods ended September 30, 2023 was $783 and $1,388, respectively, resulting from the delivery of patient EsoGuard test results.

 

Cost of Revenue

 

The cost of revenues principally includes the costs related to the Company’s laboratory operations (excluding estimated costs associated with research activities), the costs related to the EsoCheck cell collection device, cell sample mailing kits and license royalties.

 

In the three and nine month periods ended September 30, 2024, the cost of revenue was $1,684 and $4,954, respectively, primarily related to costs for our laboratory operations and EsoCheck device supplies. The Company’s cost of revenue for the three and nine month periods ended September 30, 2023 was $1,634 and $4,522, respectively, primarily related to costs for our laboratory operations and EsoCheck device supplies.

 

9
 

 

Note 5 — Related Party Transactions

 

The aggregate Due To: PAVmed Inc. for the period indicated is summarized as follows:

 

                 
   MSA Fees   Employee-Related Costs   PAVmed Inc. OBO Payments   Total 
Balance - December 31, 2023  $6,150   $3,163   $26   $9,339 
MSA fees   8,150            8,150 
ERC - Benefits       1,411        1,411 
On Behalf Of (OBO) activities           598    598 
Cash payments to PAVmed Inc.   (12,650)   (1,537)   (583)   (14,770)
Payment to PAVmed Inc. settled in LUCD stock   (1,650)   (3,025)       (4,675)
Balance - September 30, 2024  $   $12   $41   $53 

 

PAVmed - Management Services Agreement

 

The Company’s daily operations are also managed in part by personnel employed by PAVmed, for which the Company incurs a service fee, referred to as the “MSA Fee”, according to the provisions of a Management Services Agreement (“MSA”) with PAVmed. The MSA does not have a termination date, but may be terminated by the Company’s board of directors. The MSA Fee is charged on a monthly basis and is subject-to periodic adjustment corresponding with changes in the services provided by PAVmed personnel to the Company, with any such change in the MSA Fee being subject to approval of the boards of directors of each of the Company and PAVmed. In March 2024, PAVmed and the Company were authorized by their respective boards of directors to enter, and they did enter, into an eighth amendment to the MSA. Under this amendment, the monthly fee due from the Company to PAVmed was increased from $750 to $833, effective January 1, 2024. In August 2024, PAVmed and the Company were authorized by their respective boards of directors to enter, and they did enter, into a ninth amendment to the MSA. Under this amendment, the monthly fee due from the Company to PAVmed was increased from $833 to $1,050, effective July 1, 2024. During the nine months ended September 30, 2023, MSA fees were $750 per month.

 

On January 26, 2024, PAVmed elected to receive payment of $4,675 of fees and reimbursements due from Lucid, through the issuance of 3,331,771 shares of Lucid Diagnostics common stock.

 

The MSA Fee expense classification in the unaudited condensed consolidated statement of operations for the periods noted is as follows:

 

   2024   2023   2024   2023 
  

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

 
   2024   2023   2024   2023 
Sales & Marketing   164    109   $417   $218 
General & Administrative   2,253    1,554    5,860    3,108 
Research & Development   733    587    1,873    1,174 
Total MSA Fee  $3,150   $2,250   $8,150   $4,500 

 

The classification of the MSA Fee as presented above is based on the PAVmed classification of employee salary expense and other operating expenses. In this regard, PAVmed classifies employee salary expense as sales and marketing expenses for employees performing sales, sales support and marketing activities, research and development expenses for those employees who are engaged in product and services engineering development and design and /or clinical trials activities, and other employees and activities classified as general and administrative.

 

Transfer of Intellectual Property from PAVmed

 

On September 27, 2024, the Company entered into an Assignment of Patent Rights with PAVmed, pursuant to which PAVmed assigned certain patent rights to the Company related to the EsoCheck device. In consideration of the assignment the Company agreed to pay PAVmed a $350 assignment fee.

 

Note 6 — Prepaid Expenses, Deposits, and Other Current Assets

 

Prepaid expenses and other current assets consisted of the following as of:

 

   September 30, 2024   December 31, 2023 
Advanced payments to service providers and suppliers  $389   $266 
Prepaid insurance   49    607 
Deposits   1,207    1,981 
Total prepaid expenses, deposits and other current assets  $1,645   $2,854 

 

10
 

 

Note 7 — Leases

 

During the nine months ended September 30, 2024, the Company entered into additional lease agreements that have commenced and are classified as operating leases, including in June 2024, the Company exercised a renewal option to extend the lease term on its central laboratory in California for an additional three years, through December 31, 2027. The aggregate (undiscounted) rent payments are approximately $2.6 million over the extended lease term.

 

The Company’s future lease payments as of September 30, 2024, which are presented as operating lease liabilities, current portion and operating lease liabilities, less current portion on the Company’s unaudited condensed consolidated balance sheets are as follows:

 

      
2024 (remainder of year)  $266 
2025   1,025 
2026   979 
2027   940 
2028   19 
Total lease payments  $3,229 
Less: imputed interest   (363)
Present value of lease liabilities  $2,866 

 

Supplemental disclosure of cash flow information related to the Company’s cash and non-cash activities with its leases are as follows:

 

   2024   2023 
   Nine Months Ended September 30, 
   2024   2023 
Cash paid for amounts included in the measurement of lease liabilities          
Operating cash flows from operating leases  $889   $894 
Non-cash investing and financing activities          
Right-of-use assets obtained in exchange for new operating lease liabilities  $2,347   $380 
Weighted-average remaining lease term - operating leases (in years)   3.17    1.58 
Weighted-average discount rate - operating leases   7.875%   7.875%

 

As of September 30, 2024 and December 31, 2023, the Company’s right-of-use assets from operating leases were $2,860 and $1,307, respectively, which are reported in operating lease right-of-use assets in the unaudited condensed consolidated balance sheets. As of September 30, 2024 and December 31, 2023, the Company had outstanding operating lease obligations of $2,866 and $1,305, respectively, of which $855 and $1,106, respectively, are reported in operating lease liabilities, current portion and $2,011 and $199, respectively, are reported in operating lease liabilities less current portion in the Company’s unaudited condensed consolidated balance sheets. The Company calculates its incremental borrowing rates for specific lease terms, used to discount future lease payments, as a function of the financing terms the Company would likely receive on the open market.

 

11
 

 

Note 8 — Intangible Assets, net

 

Intangible assets, less accumulated amortization, consisted of the following as of:

 

   Estimated Useful Life  September 30, 2024   December 31, 2023 
Defensive technology  60 months  $2,105   $2,105 
Laboratory licenses and certifications and laboratory information management software  24 months   3,200   $3,200 
Total Intangible assets      5,305    5,305 
Less Accumulated Amortization      (4,463)   (3,881)
Intangible Assets, net     $842   $1,424 

 

Amortization expense of the intangible assets discussed above was $105 and $505 for the three month periods ended September 30, 2024 and 2023, respectively, and $582 and $1,516 for the nine month periods ended September 30, 2024 and 2023, respectively, and is included in amortization of acquired intangible assets in the accompanying unaudited condensed consolidated statements of operations. As of September 30, 2024, the estimated future amortization expense associated with the Company’s finite-lived intangible assets for each of the five succeeding fiscal years is as follows:

 

      
2024 (remainder of year)  $105 
2025   421 
2026   316 
Total  $842 

 

Note 9 — Financial Instruments Fair Value Measurements

 

Recurring Fair Value Measurements

 

The fair value hierarchy table for the reporting date noted is as follows:

 

   Fair Value Measurement on a Recurring Basis at Reporting Date Using1 
   Level-1 Inputs   Level-2 Inputs   Level-3 Inputs   Total 
September 30, 2024                    
March 2023 Senior Convertible Note  $   $   $10,200   $10,200 
Totals  $   $   $10,200   $10,200 

 

   Level-1 Inputs   Level-2 Inputs   Level-3 Inputs   Total 
December 31, 2023                    
March 2023 Senior Convertible Note  $   $   $13,950   $13,950 
Totals  $   $   $13,950   $13,950 

 

1There were no transfers between the respective Levels during the nine months ended September 30, 2024.

 

As discussed in Note 10, Debt, the Company issued a Senior Secured Convertible Note dated March 21, 2023 with a $11.1 million face value principal (“March 2023 Senior Convertible Note”). The convertible note is accounted for under the ASC 825-10-15-4 fair value option (“FVO”) election, wherein, the financial instrument is initially measured at its issue date estimated fair value and subsequently remeasured at estimated fair value on a recurring basis at each reporting period date.

 

12
 

 

Note 9 — Financial Instruments Fair Value Measurements - continued

 

The estimated fair value of the financial instruments classified within the Level 3 category was determined using both observable inputs and unobservable inputs. Unrealized gains and losses associated with liabilities within the Level 3 category include changes in fair value attributable to both observable (e.g., changes in market interest rates) and unobservable (e.g., changes in unobservable long- dated volatilities) inputs.

 

The estimated fair value of the March 2023 Senior Convertible Note as of each of September 30, 2024 and December 31, 2023 were computed using a Monte Carlo simulation of the present value of its cash flows using a synthetic credit rating analysis and a required rate-of-return, using the following assumptions:

 

   March 2023 Senior Convertible Note:
September 30, 2024
   March 2023 Senior Convertible Note:
December 31, 2023
 
Fair Value  $10,200   $13,950 
Face value principal payable  $8,669   $11,019 
Required rate of return   9.20%   10.00%
Conversion Price  $5.00   $5.00 
Value of common stock  $0.82   $1.41 
Expected term (years)   0.47    1.22 
Volatility   60.00%   60.00%
Risk free rate   4.33%   4.56%
Dividend yield   %   %

 

The estimated fair values reported utilized the Company’s common stock price along with certain Level 3 inputs (as discussed in the table above), in the development of Monte Carlo simulation models, discounted cash flow analyses, and /or Black-Scholes valuation models. The estimated fair values are subjective and are affected by changes in inputs to the valuation models and analyses, including the Company’s common stock price, the Company’s dividend yield, the risk-free rates based on U.S. Treasury security yields, and certain other Level-3 inputs including, assumptions regarding the estimated volatility in the value of the Company’s common stock price and the volatility of similar entities within the medical device industry. Changes in these assumptions can materially affect the estimated fair values.

 

Note 10 — Debt

 

The fair value and face value principal outstanding of the March 2023 Senior Convertible Note as of the dates indicated are as follows:

 

   Contractual Maturity Date  Stated Interest Rate   Conversion Price per Share   Face Value Principal Outstanding   Fair Value 
March 2023 Senior Convertible Note  March 21, 2025   7.875%  $5.00   $8,669   $10,200 
Balance as of September 30, 2024               $8,669   $10,200 

 

   Contractual Maturity Date  Stated Interest Rate   Conversion Price per Share   Face Value Principal Outstanding   Fair Value 
March 2023 Senior Convertible Note  March 21, 2025   7.875%  $5.00   $11,019   $13,950 
Balance as of December 31, 2023               $11,019   $13,950 

 

13
 

 

Note 10 — Debt - continued

 

The changes in the fair value of debt during the three and nine month periods ended September 30, 2024 is as follows:

 

   March 2023 Senior Convertible Note   Other Income (expense) 
Fair Value - June 30, 2024  $11,200   $ 
Installment repayments – common stock   (1,142)    
Non-installment payments – common stock   (180)    
Change in fair value   322    (322)
Fair Value at September 30, 2024  $10,200    - 
Other Income (Expense) - Change in fair value – three months ended September 30, 2024       $(322)

 

   March 2023 Senior Convertible Note   Other Income (expense) 
Fair Value - December 31, 2023  $13,950   $ 
Installment repayments – common stock   (2,350)    
Non-installment payments – common stock   (832)    
Change in fair value   (568)   568 
Fair Value at September 30, 2024  $10,200    - 
Other Income (Expense) - Change in fair value – nine months ended September 30, 2024       $568 

 

The changes in the fair value of debt during the three and nine month periods ended September 30, 2023 is as follows:

 

   March 2023 Senior Convertible Note   Other Income (expense) 
Fair Value - June 30, 2023  $11,610   $ 
Installment repayments – common stock   (92)    
Non-installment payments – common stock   (49)    
Change in fair value   3,021    (3,021)
Fair Value at September 30, 2023  $14,490    - 
Other Income (Expense) - Change in fair value – three months ended September 30, 2023       $(3,021)

 

   March 2023 Senior Convertible Note   Other Income (expense) 
Fair Value - December 31, 2022  $   $ 
Face value principal – issue date   11,111   $ 
Fair value adjustment – issue date   789    (789)
Installment repayments – common stock   (92)    
Non-installment payments – common stock   (49)    
Change in fair value   2,731    (2,731)
Fair Value at September 30, 2023  $14,490    - 
Other Income (Expense) - Change in fair value – nine months ended September 30, 2023       $(3,520)

 

14
 

 

Note 10 — Debt - continued

 

March 2023 Senior Secured Convertible Note

 

Lucid Diagnostics entered into a Securities Purchase Agreement (“SPA”) dated March 13, 2023, with an accredited institutional investor (“Investor”, “Lender”, and /or “Holder”), wherein Lucid agreed to sell, and the Investor agreed to purchase, an aggregate of $11.1 million face value principal of debt.

 

Under the SPA, Lucid issued in a registered direct offering under its effective shelf registration statement a Senior Secured Convertible Note dated March 21, 2023, referred to herein as the “March 2023 Senior Convertible Note”, with such note having a $11.1 million face value principal, a 7.875% annual stated interest rate, a contractual conversion price of $5.00 per share of the Company’s common stock (subject to standard adjustments in the event of any stock split, stock dividend, stock combination, recapitalization or other similar transaction), and a contractual maturity date of March 21, 2025. The March 2023 Senior Convertible Note may be converted into shares of common stock of the Company at the Holder’s election.

 

The March 2023 Senior Convertible Note proceeds were $9.925 million after deducting a $1.186 million lender fee and offering costs. The lender fee and offering costs were recognized as of the March 21, 2023 issue date as a current period expense in other income (expense) in the Company’s unaudited condensed consolidated statement of operations.

 

During the period from March 21, 2023 to September 20, 2023, the Company was required to pay interest expense only (on the $11.1 million face value principal), at 7.875% per annum, computed on a 360 day year. The Company paid cash interest expense of $149 and $391 for the three and nine months ended September 30, 2023, respectively.

 

Commencing September 21, 2023, and then on each of the successive first and tenth trading day of each month thereafter through to and including March 14, 2025 (each referred to as an “Installment Date”); and on the March 21, 2025 maturity date, the Company will be required to make a principal repayment of $292 together with accrued interest thereon, with such 38 payments referred to herein as the “Installment Amount”, settled in shares of common stock of the Company, subject to customary equity conditions, including minimum share price and volume thresholds, or at the election of the Company, in cash, in whole or in part.

 

In addition to the Installment Amount repayments, the Holder may elect to accelerate the conversion of future Installment Amount repayments, and interest thereon, subject to certain restrictions, as defined, utilizing the then current conversion price of the most recent Installment Date conversion price.

 

The payment of all amounts due and payable under this senior convertible note is guaranteed by all of Lucid Diagnostics’ subsidiaries; and the obligations under this senior convertible note are secured by all of the assets of Lucid Diagnostics and its subsidiaries.

 

Lucid is subject to certain customary affirmative and negative covenants regarding the rank of the note, along with the incurrence of further indebtedness, the existence of liens, the repayment of indebtedness and the making of investments, the payment of cash in respect of dividends, distributions or redemptions, the transfer of assets, the maturity of other indebtedness, and transactions with affiliates, among other customary matters.

 

Lucid is subject to financial covenants requiring: (i) a minimum of $5.0 million of available cash at all times; (ii) the ratio of (a) the outstanding principal amount of the total senior convertible notes outstanding, accrued and unpaid interest thereon and accrued and unpaid late charges to (b) the Company’s average market capitalization over the prior ten trading days, as of the last day of any fiscal quarter commencing with September 30, 2023, to not exceed 30%; and (iii) the Company’s market capitalization to at no time be less than $30 million. As of September 30, 2024, the Company was in compliance, and as of the date hereof, the Company is in compliance, with the Financial Tests.

 

The March 2023 Senior Convertible Note installment payments may be made in shares of Lucid Diagnostics common stock at a conversion price that is the lower of the contractual conversion price and 82.5% of the two lowest VWAPs during the last 10 trading days preceding the date of conversion, subject to a conversion price floor of $0.30. The notes are also subject to certain provisions that may require redemption upon the occurrence of an event of default, a change of control, or certain equity issuances.

 

In the three and nine month periods ended September 30, 2024, approximately $1,142 and $2,350, respectively, of principal repayments along with approximately $180 and $832, respectively, of interest expense thereon, were settled through the issuance of 2,116,717 and 4,777,898 shares, respectively, of common stock of the Company, with such shares having a fair value of approximately $1,755 and $4,293, respectively, (with such fair value measured as the respective conversion date quoted closing price of the common stock of the Company). The conversions resulted in debt extinguishment losses of $435 and $1,116 in the three and nine month periods ended September 30, 2024, respectively. Subsequent to September 30, 2024, as of November 8, 2024, approximately $2,415 of principal repayments along with approximately $63 of interest expense thereon, were settled through the issuance of 3,847,321 shares of common stock of the Company, with such shares having a fair value of approximately $3,680 (with such fair value measured as the respective conversion date quoted closing price of the common stock of the Company).

 

15
 

 

Note 10 — Debt - continued

 

March 2023 Senior Convertible Note Refinancing

 

On November 8, 2024, the Company gave notice to the holder of the March 2023 Senior Convertible Note that it was exercising its right pursuant to such note to redeem the same for the redemption price specified in such note (the “Optional Redemption Price”). Pursuant to the terms of the March 2023 Senior Convertible Note, the Company has not less than ten business days, and not more than twenty business days, from the date of the notice (the “Optional Redemption Notice Period”) to pay the Optional Redemption Price.

 

To finance the payment of the Optional Redemption Price, the Company has entered into a securities purchase agreement with certain accredited investors (the “2024 Note Investors”). Under the agreement, subject to customary closing conditions, the Company has agreed to issue, and each 2024 Note Investor has agreed to purchase, 12.0% senior secured convertible notes due 2029 (collectively, the “November 2024 Senior Convertible Notes”). As of the date hereof, the aggregate commitments of the 2024 Note Investors exceed the Lucid Optional Redemption Price. Subsequent to September 30, 2024, as of the date hereof, the Company has received cash proceeds of $7.7 million to date related to subscription agreements for the November 2024 Senior Convertible Notes.

 

The Company expects to complete the issuance of the November 2024 Senior Convertible Notes and the redemption of the March 2023 Senior Convertible Note on or prior to the end of the Optional Redemption Notice Period.

 

16
 

 

Note 11 — Stock-Based Compensation

 

Lucid Diagnostics 2018 Long-Term Incentive Equity Plan

 

The Lucid Diagnostics Inc. 2018 Long-Term Incentive Equity Plan (“Lucid Diagnostics 2018 Equity Plan”) is separate and apart from the PAVmed 2014 Equity Plan discussed below. The Lucid Diagnostics 2018 Equity Plan is designed to enable Lucid Diagnostics to offer employees, officers, directors, and consultants, an opportunity to acquire shares of common stock of Lucid Diagnostics. The types of awards that may be granted under the Lucid Diagnostics 2018 Equity Plan include stock options, stock appreciation rights, restricted stock, and other stock-based awards subject to limitations under applicable law. All awards are subject to approval by the Lucid Diagnostics compensation committee.

 

A total of 14,324,038 shares of common stock of Lucid Diagnostics are reserved for issuance under the Lucid Diagnostics 2018 Equity Plan, with 850,672 shares available for grant as of September 30, 2024. The share reservation is not diminished by a total of 523,300 stock options and 50,000 restricted stock awards granted outside the Lucid Diagnostics 2018 Equity Plan, as of September 30, 2024. In January 2024, the number of shares available for grant was increased by 2,680,038 in accordance with the evergreen provisions of the plan.

 

Lucid Diagnostics Stock Options

 

Lucid Diagnostics stock options granted under the Lucid Diagnostics 2018 Equity Plan and stock options granted outside such plan are summarized as follows:

 

   Number of Stock Options   Weighted Average Exercise Price   Remaining Contractual Term (Years)   Intrinsic Value(2) 
Outstanding stock options at December 31, 2023   5,504,383   $2.00    8.5   $765 
Granted(1)   3,604,000   $1.22           
Exercised   (3,333)  $1.31           
Forfeited   (442,501)  $1.63           
Outstanding stock options at September 30, 2024(3)   8,662,549   $1.69    8.3   $197 
Vested and exercisable stock options at September 30, 2024   3,654,937   $2.19    7.2   $197 

 

(1)Stock options granted under the Lucid Diagnostics 2018 Equity Plan and those granted outside such plan generally vest one-third in one year then ratably over the next eight quarters, and have a ten-year contractual term from date-of-grant.
(2)The intrinsic value is computed as the difference between the quoted price of the Lucid Diagnostics common stock on each of September 30, 2024 and December 31, 2023 and the exercise price of the underlying Lucid Diagnostics stock options, to the extent such quoted price is greater than the exercise price.
(3)The outstanding stock options presented in the table above are inclusive of 523,300 stock options granted outside the Lucid Diagnostics 2018 Equity Plan, as of September 30, 2024 and December 31, 2023.

 

On February 22, 2024, the company granted 2,895,000 stock options to employees and directors under the Lucid Diagnostics Inc 2018 Equity Plan with a weighted average exercise price of $1.25. Each option will vest one-third after one year then ratably over the next eight quarters.

 

17
 

 

Note 11 — Stock-Based Compensation - continued

 

Lucid Diagnostics Restricted Stock Awards

 

Lucid Diagnostics restricted stock awards granted under the Lucid Diagnostics 2018 Equity Plan and restricted stock awards granted outside such plan are summarized as follows:

 

   Number of Restricted Stock Awards   Weighted Average Grant Date Fair Value 
Unvested restricted stock awards as of December 31, 2023   2,337,440   $8.99 
Granted   1,600,000    1.03 
Vested   (26,912)   4.56 
Forfeited   (13,088)   4.56 
Unvested restricted stock awards as of September 30, 2024   3,897,440   $5.77 

 

In May 2024, a total of 1,600,000 restricted stock awards were granted to management under the Lucid Diagnostics 2018 Equity Plan, with such restricted stock awards having an aggregate fair value of approximately $1.5 million, which was measured using the grant date quoted closing price per share of Lucid Diagnostics Inc. common stock, with the fair value recognized as stock-based compensation expense ratably on a straight-line basis over the vesting period, which is commensurate with the service period. The vesting of the restricted stock awards vest on a single vest date of May 20, 2026. The restricted stock awards are subject to forfeiture if the requisite service period is not completed.

 

PAVmed Inc. 2014 Equity Plan

 

The PAVmed 2014 Long-Term Incentive Equity Plan (the “PAVmed 2014 Equity Plan”), is separate and apart from the Lucid Diagnostics 2018 Equity Plan (as such equity plan is discussed above).

 

Stock-Based Compensation Expense

 

The stock-based compensation expense recognized by the Company for both the Lucid Diagnostics 2018 Equity Plan and the PAVmed 2014 Equity Plan, for the periods indicated, was as follows:

 

   2024   2023   2024   2023 
  

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

 
   2024   2023   2024   2023 
Lucid Diagnostics 2018 Equity Plan – cost of revenue  $30   $16   $88   $44 
Lucid Diagnostics 2018 Equity Plan – sales and marketing   328    228    925    697 
Lucid Diagnostics 2018 Equity Plan - general and administrative   699    721    1,635    4,069 
Lucid Diagnostics 2018 Equity Plan - research and development   128    67    386    204 
PAVmed 2014 Equity Plan - cost of revenue   11    10    33    26 
PAVmed 2014 Equity Plan - sales and marketing   23    106    141    359 
PAVmed 2014 Equity Plan - general and administrative   1    7    5    170 
PAVmed 2014 Equity Plan - research and development   8    97    150    290 
Total stock-based compensation expense  $1,228   $1,252   $3,363   $5,859 

 

The stock-based compensation expense, as presented above, is inclusive of: stock options and restricted stock awards granted under the Lucid Diagnostics 2018 Equity Plan to employees of PAVmed, the physician inventors of the technology licensed under the Amended CWRU License Agreement, and members of the board of directors of Lucid Diagnostics, as well as the stock options granted under the PAVmed 2014 Equity Plan to the physician inventors.

 

18
 

 

Note 11 — Stock-Based Compensation - continued

 

As of September 30, 2024, unrecognized stock-based compensation expense and weighted average remaining requisite service period with respect to stock options and restricted stock awards issued under each of the Lucid Diagnostics 2018 Equity Plan and the PAVmed 2014 Equity Plan, as discussed above, is as follows:

 

   Unrecognized Expense   Weighted Average Remaining Service Period (Years) 
Lucid Diagnostics 2018 Equity Plan          
Stock Options  $3,798    2.0 
Restricted Stock Awards  $1,935    1.6 
PAVmed 2014 Equity Plan          
Stock Options  $109    1.7 

 

Stock-based compensation expense recognized with respect to stock options granted under the Lucid Diagnostics 2018 Equity Plan was based on a weighted average estimated fair value of such stock options of $0.79 per share and $0.88 per share during the nine month periods ended September 30, 2024 and 2023, respectively, calculated using the following weighted average Black-Scholes valuation model assumptions:

 

   2024   2023 
   Nine Months Ended September 30, 
   2024   2023 
Expected term of stock options (in years)   5.7    5.6 
Expected stock price volatility   73%   75%
Risk free interest rate   4.3%   3.7%
Expected dividend yield   %   %

 

Lucid Diagnostics Inc Employee Stock Purchase Plan (“Lucid ESPP”)

 

A total of 511,884 shares and 231,987 shares of common stock of Lucid Diagnostics were purchased for proceeds of approximately $353 and $276 on March 31, 2024 and 2023, respectively, under the Lucid ESPP. A total of 136,056 and 276,213 shares of common stock of Lucid Diagnostics were purchased for proceeds of approximately $94 and $275 on September 30, 2024 and 2023, respectively, under the Lucid ESPP. The Lucid ESPP has a total reservation of 1,500,000 shares of common stock of which 259,830 shares are available for issue as of September 30, 2024. In January 2024, our board authorized an increase in the number of shares available for issue by 500,000.

 

Note 12 — Stockholders’ Equity

 

Series B Preferred Stock Offering and Exchange

 

On March 13, 2024, the Company entered into subscription agreements (each, a “Series B Subscription Agreement”) and exchange agreements (each, a “Series B Exchange Agreement”) with certain accredited investors (collectively, the “Series B Investors”), which agreements provided for (i) the sale to the Series B Investors of 12,495 shares of newly designated Series B Convertible Preferred Stock, par value $0.001 per share (the “Series B Preferred Stock”), at a purchase price of $1,000 per share, and (ii) the exchange by the Series B Investors of 13,625 shares of Lucid Series A Convertible Preferred Stock, par value $0.001 per share (the “Series A Preferred Stock”), and 10,670 shares of Lucid Series A-1 Convertible Preferred Stock, par value $0.001 per share (the “Series A-1 Preferred Stock”), held by them for 31,790 shares of Series B Preferred Stock (collectively, the “Series B Offering and Exchange”). Prior to the execution of the Series B Subscription Agreements and the Series B Exchange Agreements, the Company entered into subscription agreements with certain of the Series B Investors providing for the sale to such investors of 5,670 shares of Series A-1 Preferred Stock, at a purchase price of $1,000 per share, which shares the investors immediately agreed to exchange for shares of Series B Preferred Stock pursuant to the Series B Exchange Agreements (and are included in the 10,670 shares of Series A-1 Preferred Stock set forth above). Each share of the Series B Preferred Stock has a stated value of $1,000 and a conversion price of $1.2444. The terms of the Series B Preferred Stock also include a one times preference on liquidation and a right to receive dividends equal to 20% of the number of shares of our common stock into which such Series B Preferred Stock is convertible, payable on the one-year and two-year anniversary of the issuance date. The holders of the Series B Preferred Stock also will be entitled to dividends equal, on an as-if-converted to shares of common stock basis, to and in the same form as dividends actually paid on shares of the common stock when, as, and if such dividends are paid on shares of the common stock. The Series B Preferred Stock is a voting security. The aggregate gross proceeds of these transactions were $18.1 million (inclusive of $5.7 million of aggregate gross proceeds from the sale of the Series A-1 Preferred Stock that was immediately exchanged for Series B Preferred Stock in the transactions).

 

19
 

 

Note 12 — Stockholders' Equity - continued

 

As a result of 100% of the then-outstanding shares of Series A Preferred Stock and Series A-1 Preferred Stock being exchanged for shares of Series B Preferred Stock in the Series B Offering and Exchange, no shares of Series A Preferred Stock or Series A-1 Preferred Stock remain outstanding.

 

In connection with the issuance, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of the Series B Preferred Stock with the Secretary of State of the State of Delaware (the “Certificate of Designation”). The key terms of the Series B Preferred Stock are as follows:

 

Each share of Series B Preferred Stock is convertible at the option of the holder, subject to certain beneficial ownership limitations into such number of shares of the Company’s common stock, equal to the number of Series B Preferred Shares to be converted, multiplied by the stated value of $1,000 (the “Stated Value”), divided by the conversion price in effect at the time of the conversion. The initial conversion price is $1.2444, subject to adjustment in the event of stock splits, stock dividends, and similar transactions. The Series B Preferred Stock is convertible into shares of our common stock at any time at the option of the holder from and after the six-month anniversary of its issuance, and automatically converts into shares of our common stock on March 13, 2026, the second anniversary of its issuance at a conversion price of $1.2444, and the Series B Preferred Stock is a voting security (subject to applicable ownership limitations). In addition, the Series B Preferred Stock issued in exchange for Series A Preferred Stock and Series A-1 Preferred Stock may be converted, at the election of the Company at any time after the six-month anniversary of the issuance of such shares of Series B Preferred Stock, upon written notice given to the holders of such shares, if the volume weight average price of our common stock has been at least $8.00 per share (subject to adjustment in the event of stock splits, stock dividends, and similar transactions) on 20 out of 30 consecutive trading days ending within 15 trading days prior to the date on which such notice is given (subject to certain limited exceptions) (a “VWAP-Based Mandatory Conversion”).

 

The Series B Preferred Stock will be senior to the Common Stock and any other class of the Company’s capital stock that is not by its terms senior to or pari passu with the Series B Preferred Stock.

 

The holders of Series B Preferred Stock will be entitled to dividends payable as follows: (i) a number of shares of Common Stock equal to 20% of the number of shares of Common Stock issuable upon conversion of the Series B Preferred Stock then held by such Holder on March 13, 2025, and (ii) a number of shares of Common Stock equal to 20% of the number of shares of Common Stock issuable upon conversion of the Series B Preferred Stock then held by such Holder on March 13, 2026. A holder that voluntarily converts its Series B Preferred Stock prior to March 13, 2025 or March 13, 2026, as the case may be, will not receive the dividend that accrues on such date with respect to such converted Series B Preferred Stock. The holders of the Series B Preferred Stock also will be entitled to dividends equal, on an as-if-converted to shares of Common Stock basis, to and in the same form as dividends actually paid on shares of the Common Stock when, as, and if such dividends are paid on shares of the Common Stock.

 

In the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company (or any Deemed Liquidation Event as defined in the Certificate of Designation), the holders of shares of Series B Preferred Stock then outstanding will be entitled to be paid out of the assets of the Company available for distribution to its stockholders, before any payment shall be made to the holders of Common Stock by reason of their ownership thereof, an amount per share equal to the greater of (i) the Stated Value, plus any dividends accrued but unpaid thereon, or (ii) such amount per share as would have been payable had all shares of Series B Preferred Stock been converted into Common Stock immediately prior to such event.

 

The Series B Preferred Stock is a voting security (subject to applicable ownership limitations).

 

The Company will not effect any conversion of the Series B Preferred Stock, and a holder will not have the right to receive dividends or convert any portion of the Series B Preferred Stock, to the extent that, after giving effect to the receipt of dividends or the conversion, the holder (together with such holder’s affiliates, and any persons acting as a group together with such holder or any of the holder’s affiliates) would beneficially own in excess of 4.99% of the Company’s outstanding common stock (or, upon election of the holder, 9.99% of the Company’s outstanding common stock).

 

The Company and the investors in the offering also executed a registration rights agreement (the “Series B Registration Rights Agreement”), pursuant to which the Company agreed to file a registration statement covering the resale of the shares of Common Stock issuable pursuant to the Series B Preferred Stock. The Company filed such registration statement on Form S-3 with the SEC (file number 333-280650), which filing became effective on July 18, 2024, covering the resale of the shares of Common Stock issuable pursuant to the Series B and Series B-1 Preferred Stock.

 

Series B-1 Preferred Stock Offering

 

On May 6, 2024, the Company issued approximately 11,634 shares of newly designated Series B-1 Convertible Preferred Stock (the “Series B-1 Preferred Stock”). The terms of the Series B-1 Preferred Stock are substantially identical to the terms of the Series B Preferred Stock, except that the Series B-1 Preferred Stock has a conversion price of $0.7228 and is not subject to a VWAP-Based Mandatory Conversion. The aggregate gross proceeds from the sale of shares in such offering were $11.6 million.

 

20
 

 

Note 12 — Stockholders' Equity - continued

 

Series A Preferred Stock Offering

 

On March 7, 2023, the Company issued 13,625 shares of newly designated Series A Convertible Preferred Stock, par value $0.001 per share (the “Series A Preferred Stock”). The terms of the Series A Preferred Stock were substantially identical to the terms of the Series B-1 Preferred Stock, except that the Series A Preferred Stock had a conversion price of $1.394 and was not a voting security. The aggregate gross proceeds from the sale of shares in such offering were $13.6 million.

 

As noted above, on March 13, 2024, 100% of the then-outstanding shares of Series A Preferred Stock were exchanged for shares of Series B Preferred Stock in the Series B Preferred Stock Offering and Exchange. As a result, no shares of Series A Preferred Stock remain outstanding.

 

Series A-1 Preferred Stock Offering

 

On October 17, 2023, the Company issued 5,000 shares of newly designated Series A-1 Convertible Preferred Stock (the “Series A-1 Preferred Stock”). The terms of the Series A-1 Preferred Stock were substantially identical to the terms of the Series A Preferred Stock, except that the Series A-1 Preferred Stock has a conversion price of $1.2592. The aggregate gross proceeds from the sale of shares in such offering were $5.0 million.

 

On March 13, 2024, the Company issued an additional 5,670 shares of Series A-1 Preferred Stock.

 

As noted above, on March 13, 2024, 100% of the then-outstanding shares of Series A-1 Preferred Stock were exchanged for shares of Series B Preferred Stock in the Series B Preferred Stock Offering and Exchange. As a result, no shares of Series A-1 Preferred Stock remain outstanding.

 

Deemed Dividend on Series A and Series A-1 Convertible Preferred Stock Exchange Offer

 

The fair value of the consideration given in the form of the issue of 31,790 shares of Series B Convertible Preferred Stock, with such fair value recognized as the carrying value of such issued shares of Series B Convertible Preferred Stock, as compared to the carrying value of the extinguished Series A and Series A-1 Convertible Preferred Stock (carrying value of $24,294), resulting in an excess of fair value of $7.5 million recognized as a deemed dividend charged to accumulated deficit in the unaudited condensed consolidated balance sheet on March 13, 2024, with such deemed dividend included as a component of net loss attributable to common stockholders, summarized as follows:

 

Series B Convertible Preferred Stock Issuance and Series A/A-1 Exchange Offer  March 13, 2024 
     
Fair Value - 31,790 shares of Series B Preferred Stock issued in exchange for Series A and Series A-1 Preferred Stock  $31,790 
Less: Carrying value related to Series A and Series A-1 Preferred Stock Exchanged for Series B Preferred Stock (of 24,295 shares)   (24,294)
Deemed Dividend Charged to Accumulated Deficit  $7,496 

 

Lucid Diagnostics Common Stock

 

In July 2024, the Company received shareholder approval to amend its certificate of incorporation, as amended, to increase the total number of shares of common stock the Company is authorized to issue by 100 million shares from 200 million shares to 300 million shares. An amendment effecting such change was filed with the Secretary of State of Delaware on July 23, 2024.

 

Additionally in July 2024, the Company’s shareholders approved, for purposes of Listing Rule 5635 of The Nasdaq Stock Market LLC (“Nasdaq”) the issuance of shares of the Company’s common stock under the Series B Convertible Preferred Stock (“Series B Preferred Stock”) sold by the Company in a private offering in March 2024 and the Series B-1 Convertible Preferred Stock (“Series B-1 Preferred Stock”) sold by the Company in a private offering in May 2024. Each of the Series B and Series B-1 Preferred Stock is a voting security. On any matter to be acted upon or considered by the stockholders of the Company, each holder shall be entitled to vote on an “as converted” basis after applying the beneficial ownership limitations described in the Series B and B-1 Preferred Stock Offering above.

 

As of September 30, 2024 and December 31, 2023, there were 51,597,718 and 42,329,864 shares of common stock issued and outstanding, respectively. On September 10, 2024, following preferred equity transactions completed by the Company earlier in 2024 and the termination of voting proxies entered into between PAVmed and certain shareholders of the Company, PAVmed’s voting interest in the Company was reduced to less than 50.0%, resulting in the loss of a controlling financial interest. However, PAVmed retains the ability to exercise significant influence over Lucid. As of September 30, 2024, PAVmed holds 31,302,444 shares.

 

On January 26, 2024, PAVmed elected to receive payment of $4,675 of fees and reimbursements due from Lucid, through the issuance of 3,331,771 shares of Lucid Diagnostics common stock. Substantially all of such shares were distributed by PAVmed to its shareholders on February 15, 2024.

 

21
 

 

Note 12 — Stockholders' Equity - continued

 

On June 21, 2024, the Company received a notice from the Listing Qualifications Department of Nasdaq stating that, for the prior 30 consecutive business days (through June 20, 2024), the closing bid price of the Company’s common stock had been below the minimum of $1 per share required for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). The notification letter stated that the Company would be afforded 180 calendar days (until December 18, 2024) to regain compliance, and that the Company could be eligible for additional time. The Company intends to consider all available options to regain compliance with the Nasdaq listing standards.

 

In the nine months ended September 30, 2024, the Company issued 480,000 shares of common stock to vendors in exchange for $401 of agreed upon services, which is included in general and administrative operating expenses on the Company’s unaudited condensed consolidated statement of operations.

 

Committed Equity Facility and ATM Facility

 

On March 28, 2022, the Company entered into a committed equity facility with an affiliate of Cantor Fitzgerald (“Cantor”). Under the terms of the committed equity facility, Cantor has committed to purchase up to $50 million of the Company’s common stock from time to time at the request of the Company. While there are distinct differences, the facility is structured similarly to a traditional at-the-market equity facility, insofar as it allows the Company to raise primary equity capital on a periodic basis at prices based on the existing market price. Cumulatively a total of 680,263 shares of Lucid Diagnostics’ common stock were issued for net proceeds of approximately $1.8 million, after a 4% discount, as of September 30, 2024.

 

In November 2022, the Company entered into an “at-the-market offering” (“ATM”) for up to $6.5 million of its common stock that may be offered and sold under a Controlled Equity Offering Agreement between the Company and Cantor. Cumulatively a total of 230,068 shares of Lucid Diagnostics’ common stock were issued through the at-the-market equity facility for net proceeds of approximately $0.3 million, after payments of 3% commissions, as of September 30, 2024.

 

22
 

 

Note 13 — Net Loss Per Share

 

The Net loss per share basic and diluted for the respective periods indicated is as follows:

 

   2024   2023   2024   2023 
  

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

 
   2024   2023   2024   2023 
Numerator                
Net loss  $(12,371)  $(14,208)  $(33,988)  $(41,836)
Deemed dividend on Series A and Series A-1 Convertible Preferred Stock           (7,496)    
Net loss attributable to Lucid Diagnostics Inc. common stockholders  $(12,371)  $(14,208)  $(41,484)  $(41,836)
                     
Denominator                    
Weighted average common shares outstanding, basic and diluted   50,374,146    41,862,805    47,876,015    41,558,979 
                     
Net loss per share (1)                    
Net loss per share - basic and diluted  $(0.25)  $(0.34)  $(0.87)  $(1.01)

 

(1) - Convertible Preferred Stock would potentially be considered a participating security under the two-class method of calculating net loss per share. However, the Company has incurred net losses to-date, and as such holders are not contractually obligated to share in the losses, there is no impact on the Company’s net loss per share calculation for the periods indicated.

 

Basic weighted-average number of shares of common stock outstanding for the nine month periods ended September 30, 2024 and 2023 include the shares of the Company issued and outstanding during such periods, each on a weighted average basis. The basic weighted average number of shares common stock outstanding excludes common stock equivalent incremental shares, while diluted weighted average number of shares outstanding includes such incremental shares. However, as the Company was in a loss position for all years presented, basic and diluted weighted average shares outstanding are the same, as the inclusion of the incremental shares would be anti-dilutive. The common stock equivalents excluded from the computation of diluted weighted average shares outstanding are as follows:

 

   2024   2023 
   September 30, 
   2024   2023 
         
Stock options   8,662,549    4,957,215 
Unvested restricted stock awards   3,897,440    1,787,440 
Preferred stock   51,682,378    13,683,647 
Total   64,242,367    20,428,302 

 

 

23
 

 

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

 

The following discussion and analysis of our unaudited condensed consolidated financial condition and results of operations should be read together with our Annual Report on Form 10-K for the year ended December 31, 2023 (the “Form 10-K”), as filed with the Securities and Exchange Commission (the “SEC”).

 

Unless the context otherwise requires, (i) “we”, “us”, and “our”, and the “Company”, “Lucid” and “Lucid Diagnostics” refer to Lucid Diagnostics Inc. and its subsidiaries LucidDx Labs Inc. (“LucidDx Labs”) and CapNostics, LLC (“CapNostics”), (ii) “FDA” refers to the Food and Drug Administration, (iii) “510(k)” refers to a premarket notification, submitted to the FDA by a manufacturer pursuant to § 510(k) of the Food, Drug and Cosmetic Act and 21 CFR § 807 subpart E, (iv) “CLIA” refers to the Clinical Laboratory Improvement Amendments of 1988 and associated regulations set forth in 42 CFR § 493, (v) “CE Mark” refers to a “Conformité Européenne” Mark, a mark indicating that a product such as a medical device conforms to the essential requirements of the relevant European directive, and (vi) “LDT” refers to a diagnostic test, defined by the FDA as “an IVD that is intended for clinical use and designed, manufactured and used within a single laboratory,” which is generally subject only to self-certification of analytical validity under the CMS CLIA program.

 

FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q (this “Form 10-Q”), including the following discussion and analysis of our unaudited condensed consolidated financial condition and results of operations, contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Form 10-Q, including statements regarding our future results of operations and financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. The words “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements are not guarantees of future performance and the Company’s actual results may differ significantly from those expressed or implied in the forward-looking statements. Factors that might cause such differences include, but are not limited to, those discussed in Item 1A of Part I of the Form 10-K under the heading “Risk Factors.”

 

Important factors that may affect our actual results include:

 

our limited operating history;
our financial performance, including our ability to generate revenue;
our ability to obtain regulatory approval for the commercialization of our products;
the risk that the FDA will cease to exercise enforcement discretion with respect to LDTs, like EsoGuard;
the ability of our products to achieve market acceptance;
our success in retaining or recruiting, or changes required in, our officers, key employees or directors;
our potential ability to obtain additional financing when and if needed;
our ability to protect our intellectual property;
our ability to complete strategic acquisitions;
our ability to manage growth and integrate acquired operations;
the potential liquidity and trading of our securities;
our regulatory and operational risks;
cybersecurity risks;
risks related to the COVID-19 pandemic and other health-related emergencies;
risks related to our relationship with PAVmed; and
our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.

 

In addition, our forward-looking statements do not reflect the potential impact of any future financing, acquisitions, mergers, dispositions, joint ventures or investments we may make.

 

We may not actually achieve the results, plans and/or objectives disclosed in our forward-looking statements, and the intended or expected developments and/or other events disclosed in our forward-looking statements may not actually occur, and accordingly you should not place undue reliance on our forward-looking statements. You should read this Form 10-Q and the documents we have filed as exhibits to this Form 10-Q and the Form 10-K completely and with the understanding our actual future results may be materially different from what we expect. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

 

24
 

 

Overview

 

We are a commercial-stage, cancer prevention medical diagnostics technology company focused on the millions of patients who are at risk of developing esophageal precancer and cancer, specifically highly lethal esophageal adenocarcinoma (“EAC”).

 

We believe that our flagship product, the EsoGuard Esophageal DNA Test, performed on samples collected with the EsoCheck Esophageal Cell Collection Device, constitutes the first and only commercially available diagnostic test capable of serving as a widespread tool for the early detection of esophageal precancer, including Barrett’s Esophagus (“BE”), in at-risk patients. Early detection of esophageal precancer allows patients to undergo appropriate monitoring and treatment, as indicated by clinical practice guidelines, in an effort to prevent progression to esophageal cancer.

 

EsoGuard is a bisulfite-converted targeted next-generation sequencing (NGS) DNA assay performed on surface esophageal cells collected with EsoCheck. It quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1). The assay has been evaluated in multiple studies, demonstrating sensitivity of ~90% for detecting disease along the full esophageal precancer to cancer spectrum, with a negative predictive value (NPV) of ~99%. Sensitivity and NPV remain very high even for detecting early precancer, which is unprecedented for a molecular diagnostic test.

 

EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells in a less than five-minute office procedure. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from which a soft silicone balloon with textured ridges emerges to gently swab surface esophageal cells. When vacuum suction is applied, the balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted region during device withdrawal. We believe this proprietary Collect+Protect™ technology makes EsoCheck the only noninvasive esophageal cell collection device capable of such anatomically targeted and protected sampling.

 

EsoGuard and EsoCheck are based on patented technology licensed by Lucid from Case Western Reserve University (“CWRU”). EsoGuard and EsoCheck have been developed to provide an accurate, non-invasive, patient-friendly test for the early detection of EAC and BE, including dysplastic BE and related precursors to EAC in patients with gastroesophageal reflux disease (“GERD”), commonly known as chronic heartburn, acid reflux, or just reflux.

 

Recent Developments

 

Business

 

American Journal of Gastroenterology Publication

 

On November 7, 2024, the Company announced that its manuscript for its multi-center ESOGUARD BE-1 study has been accepted for publication in The American Journal of Gastroenterology, the official journal of the American College of Gastroenterology (ACG). This is the fourth publication presenting clinical validation data for the Company’s EsoGuard® Esophageal DNA Test, and the second to demonstrate its performance in an intended-use screening population. Consistent with previous studies, EsoGuard showed high sensitivity and negative predictive value in detecting esophageal precancer (Barrett’s Esophagus or BE). With the acceptance for publication, the Company believes we now have a complete clinical evidence package to submit our data to the MolDX program and formally seek Medicare coverage.

 

The prospective, multi-center study presented data from a cohort of patients who met ACG guideline criteria for esophageal precancer screening and underwent non-endoscopic EsoGuard testing followed by traditional upper endoscopy. EsoGuard sensitivity and negative predictive value for detecting BE were approximately 88% and 99%, respectively. Specificity and positive predictive value were approximately 81% and 30%, respectively. No serious adverse events were reported.

 

Intercompany Agreements with PAVmed

 

On August 6, 2024, PAVmed and the Company entered into a ninth amendment to the management services agreement between PAVmed and Lucid (“MSA”) to increase the monthly fee thereunder from $0.83 million per month to $1.05 million per month, effective as of July 1, 2024.

 

On March 22, 2024, PAVmed and the Company entered into an eighth amendment to the MSA to increase the monthly fee thereunder from $0.75 million per month to $0.83 million per month, effective as of January 1, 2024. The amendment also reset the maximum number of shares issuable under the agreement to 19.99% of the shares outstanding as of the date of the amendment.

 

On January 26, 2024, in accordance with the MSA and the payroll, benefits and expense reimbursement agreement between PAVmed and Lucid (“PBERA”), PAVmed elected to receive payment of approximately $4.7 million of fees and reimbursements accrued under the MSA and the PBERA through the issuance of 3,331,771 shares of Lucid’s common stock.

 

FDA Enforcement Discretion

 

In April 2024, FDA published the final rule under which FDA intends to phase out its general enforcement discretion approach for LDTs so that IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs (the proposed rule was published in October 2023). In the final rule, FDA has expanded the categories of LDTs that will be eligible for continued enforcement discretion, which categories include LDTs first marketed prior to May 6, 2024 and LDTs approved by New York State’s Clinical Laboratory Evaluation Program (“NYS CLEP”). As EsoGuard was marketed prior to the cutoff date, and is also NYS CLEP-approved, EsoGuard will remain under continued enforcement discretion from FDA’s premarket review requirements and quality systems requirements (except for record-keeping). As such, there is no immediate impact from the final rule on Lucid’s regulatory strategy.

 

Appointment of Dennis Matheis to Board of Directors

 

On May 6, 2024, the board of directors of the Company appointed Dennis Matheis as a Class C director of the Company (and he was subsequently re-elected to the board, together with the incumbent Class C directors of the Company, at the Company’s annual shareholders meeting held on July 23, 2024). In connection with his joining the board, Mr. Matheis received a grant of an option to acquire 241,500 shares of the Company’s common stock pursuant to the Company’s Amended and Restated 2018 Long-Term Incentive Equity Plan in accordance with the Company’s existing compensation policy for non-employee directors.

 

25
 

 

Recent Developments - continued

 

Business - continued

 

NASDAQ Notice

 

On June 21, 2024, the Company received a notice from the Listing Qualifications Department of Nasdaq stating that, for the prior 30 consecutive business days (through June 20, 2024), the closing bid price of the Company’s common stock had been below the minimum of $1 per share required for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). The notification letter stated that the Company would be afforded 180 calendar days (until December 18, 2024) to regain compliance, and that the Company could be eligible for additional time. The Company intends to consider all available options to regain compliance with the Nasdaq listing standards.

 

Authorized Shares Increase

 

On July 23, 2024, the Company filed an amendment to its Certificate of Incorporation to effectuate an increase in its authorized shares from 200,000,000 to 300,000,000. Such increase was approved at the annual meeting of the Company’s stockholders held the same day.

 

Lucid IP Matters

 

On October 15, 2024, the Company announced that it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a patent application covering its proprietary method of using methylation of the cyclin-A1 (CCNA1) gene to help detect esophageal precancer and cancer, a key component of its EsoGuard® Esophageal DNA Test.

 

EsoGuard utilizes next-generation sequencing (NGS) to assess DNA methylation at 31 sites on two genes, vimentin (VIM) and cyclin-A1 (CCNA1). Such methylation has been shown to be strongly associated with conditions along the spectrum from early esophageal precancer (non-dysplastic Barrett’s Esophagus or BE), to late precancer (dysplastic BE), to cancer (esophageal adenocarcinoma). Although VIM methylation had been previously associated with gastrointestinal neoplasias, the association of CCNA1 methylation with esophageal neoplasia is novel and appears to be more specific.

 

Financing

 

March 2023 Senior Convertible Note Refinancing

 

On November 8, 2024, the Company gave notice to the holder of the March 2023 Senior Convertible Note that it was exercising its right pursuant to such note to redeem the same for the redemption price specified in such note (the “Optional Redemption Price”). Pursuant to the terms of the March 2023 Senior Convertible Note, the Company has not less than ten business days, and not more than twenty business days, from the date of the notice (the “Optional Redemption Notice Period”) to pay the Optional Redemption Price.

 

To finance the payment of the Optional Redemption Price, the Company has entered into a securities purchase agreement with certain accredited investors (the “2024 Note Investors”). Under the agreement, subject to customary closing conditions, the Company has agreed to issue, and each 2024 Note Investor has agreed to purchase, 12.0% senior secured convertible notes due 2029 (collectively, the “November 2024 Senior Convertible Notes”). As of the date hereof, the aggregate commitments of the 2024 Note Investors exceed the Optional Redemption Price.

 

The Company expects to complete the issuance of the November 2024 Senior Convertible Notes and the redemption of the March 2023 Senior Convertible Note on or prior to the end of the Optional Redemption Notice Period, although there can be no assurance that such issuance and redemption will be completed during such period, if at all.

 

Series B and Series B-1 Preferred Stock Offerings

 

On March 13, 2024, we entered into subscription agreements (each, a “Series B Subscription Agreement”) and exchange agreements (each, a “Series B Exchange Agreement”) with certain accredited investors (collectively, the “Series B Investors”), which agreements provided for (i) the sale to the Series B Investors of 12,495 shares of our newly designated Series B Convertible Preferred Stock, par value $0.001 per share (the “Series B Preferred Stock”), at a purchase price of $1,000 per share, and (ii) the exchange by the Series B Investors of 13,625 shares of our Series A Convertible Preferred Stock, par value $0.001 per share (the “Series A Preferred Stock”), and 10,670 shares of our Series A-1 Convertible Preferred Stock, par value $0.001 per share (the “Series A-1 Preferred Stock”), held by them for 31,790 shares of Series B Preferred Stock (collectively, the “Series B Offering and Exchange”). Prior to the execution of the Series B Subscription Agreements and the Series B Exchange Agreements, we entered into subscription agreements with certain of the Series B Investors providing for the sale to such investors of 5,670 shares of Series A-1 Preferred Stock, at a purchase price of $1,000 per share, which shares the investors immediately agreed to exchange for shares of Series B Preferred Stock pursuant to the Series B Exchange Agreements (and are included in the 10,670 shares of Series A-1 Preferred Stock set forth above). Each share of the Series B Preferred Stock has a stated value of $1,000 and a conversion price of $1.2444. The terms of the Series B Preferred Stock also include a one times preference on liquidation and a right to receive dividends equal to 20% of the number of shares of our common stock into which such Series B Preferred Stock is convertible, payable on the one-year and two-year anniversary of the issuance date. The holders of the Series B Preferred Stock also will be entitled to dividends equal, on an as-if-converted to shares of common stock basis, to and in the same form as dividends actually paid on shares of the common stock when, as, and if such dividends are paid on shares of the common stock. The Series B Preferred Stock is a voting security. The aggregate gross proceeds of these transactions were $18.16 million (inclusive of $5.67 million of aggregate gross proceeds from the sale of the Series A-1 Preferred Stock that was immediately exchanged for Series B Preferred Stock in the transactions).

 

As a result of 100% of the then-outstanding shares of Series A Preferred Stock and Series A-1 Preferred Stock being exchanged for shares of Series B Preferred Stock in the Series B Offering and Exchange, no shares of Series A Preferred Stock or Series A-1 Preferred Stock remain outstanding.

 

On May 6, 2024, the Company issued approximately 11,634 shares of newly designated Series B-1 Convertible Preferred Stock (the “Series B-1 Preferred Stock”). The terms of the Series B-1 Preferred Stock are substantially identical to the terms of the Series B Preferred Stock, except that the Series B-1 Preferred Stock has a conversion price of $0.7228. The aggregate gross proceeds from the sale of shares in such offering were $11.6 million.

 

The aggregate gross proceeds from the issuances of the Series B Preferred Stock and Series B-1 Preferred Stock were approximately $29.8 million.

 

26
 

 

Results of Operations

 

Overview

 

Revenue

 

The Company recognized revenue resulting from the delivery of patient EsoGuard test results when the Company considered the collection of such consideration to be probable to the extent that it is unconstrained.

 

Cost of revenue

 

Cost of revenues recognized from the delivery of patient EsoGuard test results includes costs related to EsoCheck device usage, shipment of test collection kits, royalties and the cost of services to process tests and provide results to physicians. We incur expenses for tests in the period in which the activities occur, therefore, gross margin as a percentage of revenue may vary from quarter to quarter due to costs being incurred in one period that relate to revenues recognized in a later period.

 

We expect that the gross margin for our services will continue to fluctuate and be affected by EsoGuard test volume, our operating efficiencies, patient compliance rates, payer mix, the levels of reimbursement, and payment patterns of payers and patients.

 

Sales and marketing expenses

 

Sales and marketing expenses consist primarily of salaries and related costs for employees engaged in sales, sales support and marketing activities, as well as the portion of the MSA Fee (as defined in Note 5, Related Party Transactions, to our accompanying unaudited condensed consolidated financial statements) allocated to sales and marketing expenses, which are principally costs related to PAVmed employees who are performing services for the Company. We anticipate our sales and marketing expenses will increase in the future, to the extent we expand our commercial sales and marketing operations as resources permit and insurance reimbursement coverage for our EsoGuard test expands.

 

General and administrative expenses

 

General and administrative expenses consist primarily of professional fees for accounting, tax, audit and legal services (including those fees incurred as a result of our being a public company), consulting fees, expenses associated with obtaining and maintaining patents within our intellectual property portfolio, and certain employee costs, along with the portion of the MSA Fee allocated to general and administrative expenses.

 

We anticipate our general and administrative expenses will increase in the future to the extent our business operations grow. Furthermore, we anticipate continued expenses related to being a public company, including fees and expenses for audit, legal, regulatory, tax-related services, insurance premiums and investor relations costs associated with maintaining compliance as a public company.

 

Research and development expenses

 

Research and development expenses are recognized in the period they are incurred and consist principally of internal and external expenses incurred for the development of our technologies and conducting clinical trials, including:

 

costs associated with regulatory filings;
patent license fees;
cost of laboratory supplies and acquiring, developing, and manufacturing preclinical prototypes; and
the portion of the MSA Fee allocated to research and development.

 

We plan to incur research and development expenses for the foreseeable future as we continue the development of our existing products as well as new innovations. Our research and development activities, including our clinical trials, are focused principally on facilitating insurer reimbursement, encouraging physician adoption and developing product improvements or extending the utility of the lead products in our pipeline, including EsoCheck and EsoGuard.

 

Other Income and Expense, net

 

Other income and expense, net, consists principally of changes in fair value of our convertible note and losses on extinguishment of debt upon repayment of such convertible note.

 

Presentation of Dollar Amounts

 

All dollar amounts in this Management’s Discussion and Analysis of Financial Condition and Results of Operations are presented as dollars in millions, except for share and per share amounts.

 

27
 

 

Results of Operations - continued

 

The three months ended September 30, 2024 as compared to the three months ended September 30, 2023

 

Revenue

 

In the three months ended September 30, 2024, revenue was $1.2 million as compared to $0.8 million for the corresponding period in the prior year. The $0.4 million increase principally relates to the increase in volume of our EsoGuard Esophageal DNA Tests performed in our CLIA laboratory for the period and the consideration received for the performance of the EsoGuard Esophageal DNA Tests.

 

Cost of revenue

 

In the three months ended September 30, 2024, the cost of revenue was approximately $1.7 million as compared to $1.6 million for the corresponding period in the prior year. The net increase of $0.1 million was principally related to:

 

approximately $0.2 million decrease in manufacturing costs associated with the EsoCheck devices and EsoGuard Esophageal DNA Tests;
approximately $0.2 million increase in third party professional and IT related expenses; and
approximately $0.1 million increase in compensation and stock-based compensation costs.

 

Sales and marketing expenses

 

In the three months ended September 30, 2024, sales and marketing costs were approximately $4.1 million as compared to $3.8 million for the corresponding period in the prior year. The net increase of $0.3 million was principally related to:

 

approximately $0.3 million increase in compensation and stock-based compensation costs.

 

General and administrative expenses

 

In the three months ended September 30, 2024, general and administrative costs were approximately $5.4 million as compared to $4.3 million for the corresponding period in the prior year. The net increase of $1.1 million was principally related to:

 

approximately $0.6 million increase related to the amended MSA with PAVmed due to the growth and expansion of our business and the services incurred through PAVmed;
approximately $0.4 million increase in compensation related costs; and
approximately $0.1 million increase in third-party professional services related to investor relations and other third-party professional services.

 

Research and development expenses

 

In the three months ended September 30, 2024, research and development costs were approximately $1.7 million, compared to $1.6 million for the corresponding period in the prior year. The net increase of $0.1 million was principally related to:

 

approximately $0.1 million increase in development costs, particularly in clinical trial activities and outside professional and consulting fees.

 

Amortization of Acquired Intangible Assets

 

The amortization of acquired intangible assets was approximately $0.1 million in the three months ended September 30, 2024, as compared to $0.5 million for the corresponding period in the prior year. The decrease of $0.4 million in the current period was due to certain acquired intangible assets being fully amortized in February 2024.

 

Other Income and Expense

 

Change in fair value of convertible debt

 

In the three months ended September 30, 2024, the change in the fair value of our convertible note was approximately $0.3 million of expense, related to the March 2023 Senior Convertible Note (as defined in Note 10, Debt, to our accompanying unaudited condensed consolidated financial statements). The March 2023 Senior Convertible Note was initially measured at its issue-date estimated fair value and subsequently remeasured at estimated fair value as of each reporting period date. The Company initially recognized a $0.8 million fair value non-cash expense on the issue date.

 

28
 

 

Results of Operations - continued

 

The three months ended September 30, 2024 as compared to three months ended September 30, 2023 - continued

 

Loss on Debt Extinguishment

 

In the three months ended September 30, 2024, a debt extinguishment loss in the aggregate of approximately $0.4 million was recognized in connection with our March 2023 Senior Convertible Note as discussed below.

 

In the three months ended September 30, 2024, approximately $1.1 million of principal repayments along with approximately $0.2 million of interest expense thereon, were settled through the issuance of 2,116,717 shares of common stock of the Company, with such shares having a fair value of approximately $1.8 million (with such fair value measured as the quoted closing price of the common stock of the Company on the respective conversion date). The conversions resulted in a debt extinguishment loss of $0.4 million in the three months ended September 30, 2024. The Company incurred less than $0.1 million of debt extinguishment losses in the three months ended September 30, 2023.

 

See Note 10, Debt, to our accompanying unaudited condensed consolidated financial statements, for additional information with respect to the March 2023 Senior Convertible Note.

 

The nine months ended September 30, 2024 as compared to nine months ended September 30, 2023

 

Revenue

 

In the nine months ended September 30, 2024, revenue was $3.1 million as compared to $1.4 million for the corresponding period in the prior year. The $1.7 million increase principally relates to the revenue for our EsoGuard Esophageal DNA Test performed in our CLIA laboratory for the period and the consideration received for the performance of the EsoGuard Esophageal DNA Test.

 

Cost of revenue

 

In the nine months ended September 30, 2024, the cost of revenue was approximately $5.0 million as compared to $4.5 million for the corresponding period in the prior year. The $0.5 million increase was principally related to:

 

approximately $0.3 million decrease in manufacturing costs associated with the EsoCheck devices and EsoGuard Esophageal DNA Tests;
approximately $0.3 million increase in compensation related costs, including stock-based compensation;
approximately $0.3 million increase in third party professional fees and IT services; and
approximately $0.2 million increase in the CLIA laboratory supplies required to perform the EsoGuard Esophageal DNA tests and in royalty costs for the test.

 

Sales and marketing expenses

 

In the nine months ended September 30, 2024, sales and marketing costs were approximately $12.5 million as compared to $12.0 million for the corresponding period in the prior year. The net increase of $0.5 million was principally related to:

 

approximately $0.4 million increase in compensation related costs principally as a result of changes in headcount and bonus structure and travel expenses; and
approximately $0.1 million increase related to the amended MSA with PAVmed due to the growth and expansion of our business and the services incurred through PAVmed.

 

General and administrative expenses

 

In the nine months ended September 30, 2024, general and administrative costs were approximately $14.3 million as compared to $15.0 million for the corresponding period in the prior year. The net decrease of $0.7 million was principally related to:

 

approximately $2.6 million decrease in stock-based compensation;
approximately $1.1 million increase related to the amended MSA with PAVmed due to the growth and expansion of our business and the services incurred through PAVmed;
approximately $0.9 million increase in compensation costs; and
approximately $0.1 million decrease in third-party professional fees, expenses related to the termination of the management services agreement with our former laboratory provider, and expenses for finance and legal services.

 

Research and development expenses

 

In the nine months ended September 30, 2024, research and development costs were approximately $4.5 million, compared to $5.3 million for the corresponding period in the prior year. The net decrease of $0.8 million was principally related to:

 

approximately $0.8 million decrease in development costs, particularly in clinical trial activities and outside professional and consulting fees.

 

29
 

 

Results of Operations - continued

 

The nine months ended September 30, 2024 as compared to nine months ended September 30, 2023 - continued

 

Amortization of Acquired Intangible Assets

 

The amortization of acquired intangible assets was approximately $0.6 million in the nine months ended September 30, 2024, as compared to $1.5 million for the corresponding period in the prior year. The decrease of $0.9 million in the current period was due to certain acquired intangible assets being fully amortized in February 2024.

 

Other Income and Expense

 

Change in fair value of convertible debt

 

In the nine months ended September 30, 2024, the change in the fair value of our convertible note was approximately $0.6 million of income, related to the March 2023 Senior Convertible Note (as defined in Note 10, Debt, to our accompanying unaudited condensed consolidated financial statements). The March 2023 Senior Convertible Note was initially measured at its issue date estimated fair value and subsequently remeasured at estimated fair value as of each reporting period date. The Company initially recognized a $0.8 million fair value remeasurement as a non-cash expense on the issue date.

 

Loss on Issue and Offering Costs - Senior Secured Convertible Note

 

In the nine months ended September 30, 2023, in connection with the issue of the March 2023 Senior Convertible Note, we recognized a total of approximately $1.2 million of lender fee and offering costs paid by us. The Company did not incur lender fees and offering costs in the nine months ended September 30, 2024.

 

Loss on Debt Extinguishment

 

In the nine months ended September 30, 2024, a debt extinguishment loss in the aggregate of approximately $1.1 million was recognized in connection with our March 2023 Senior Convertible Note as discussed below.

 

In the nine months ended September 30, 2024, approximately $2.4 million of principal repayments along with approximately $0.8 million of interest expense thereon, were settled through the issuance of 4,777,898 shares of common stock of the Company, with such shares having a fair value of approximately $4.3 million (with such fair value measured as the quoted closing price of the common stock of the Company on the respective conversion date). The conversions resulted in a debt extinguishment loss of $1.1 million in the nine months ended September 30, 2024. The Company incurred less than $0.1 million of debt extinguishment losses in the nine months ended September 30, 2023.

 

See Note 10, Debt, to our accompanying unaudited condensed consolidated financial statements, for additional information with respect to the March 2023 Senior Convertible Note.

 

Deemed Dividend on Series A and Series A-1 Convertible Preferred Stock Exchange Offer

 

The fair value of the consideration given in the form of the issue of 31,790 shares of Series B Convertible Preferred Stock, with such fair value recognized as the carrying value of such issued shares of Series B Convertible Preferred Stock, as compared to the carrying value of the extinguished Series A and Series A-1 Convertible Preferred Stock (carrying value of $24.3 million), resulting in an excess of fair value of $7.5 million recognized as a deemed dividend charged to accumulated deficit in the unaudited condensed consolidated balance sheet on March 13, 2024, with such deemed dividend included as a component of net loss attributable to common stockholders, summarized as follows:

 

Series B Convertible Preferred Stock Issuance and Series A/A-1 Exchange Offer  March 13, 2024 
     
Fair Value - 31,790 shares of Series B Preferred Stock issued in exchange for Series A and Series A-1 Preferred Stock  $31,790 
Less: Carrying value related to Series A and Series A-1 Preferred Stock Exchanged for Series B Preferred Stock (of 24,295 shares)   (24,294)
Deemed Dividend Charged to Accumulated Deficit  $7,496 

 

30
 

 

Liquidity and Capital Resources

 

Our current operational activities are principally focused on the commercialization of EsoGuard. We are pursuing commercialization across multiple sales channels, including: the communication to and education of medical practitioners and clinicians regarding EsoGuard; the establishment of Lucid Test Centers for the collection of cell samples using EsoCheck; use of our mobile testing unit; ongoing #CheckYourFoodTube testing days; and our direct contracting strategic initiative (including in the concierge medicine and employer markets sectors). Additionally, we are developing expanded clinical evidence to support insurance reimbursement adoption by government and private insurers. Further, as resources permit, the Company also intends to pursue development of other products and services.

 

Our ability to generate revenue depends upon our ability to successfully advance the commercialization of EsoGuard, including significantly expanding insurance reimbursement coverage, while also completing the clinical studies, product and service development, and necessary regulatory approval thereof. There are no assurances, however, we will be able to obtain an adequate level of financial resources required for the long-term commercialization and development of our products and services.

 

We are subject to all of the risks and uncertainties typically faced by medical device and diagnostic companies that devote substantially all of their efforts to the commercialization of their initial products and services, to ongoing research and development activities, and to conducting clinical trials. We experienced a net loss of approximately $34.0 million and used approximately $34.3 million of cash in operations during the nine month period ended September 30, 2024. Financing activities provided $30.2 million of cash during the nine month period ended September 30, 2024. We ended the quarter with cash on-hand of $14.5 million as of September 30, 2024. We expect to continue to experience recurring losses and negative cash flow from operations, and will continue to fund our operations with debt and/or equity financing transactions, which in accordance with management’s plans may include conversions of our existing debt to equity and refinancing our existing debt obligations to extend the maturity date. The Company’s ability to continue operations 12 months beyond the issuance of the financial statements will depend upon generating substantial revenue that is conditioned on obtaining positive third-party reimbursement coverage for its EsoGuard Esophageal DNA Test from both government and private health insurance providers, increasing revenue through contracting directly with self-insured employers, and upon raising additional capital through various potential sources including equity and/or debt financings or refinancing existing debt obligations. These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the accompanying unaudited condensed consolidated financial statements are issued.

 

Preferred Stock Offerings

 

On March 13, 2024, we entered into the Series B Subscription Agreements and Series B Exchange Agreements with the Series B Investors, which agreements provided for (i) the sale to the Series B Investors of 12,495 shares of our newly designated Series B Preferred Stock, at a purchase price of $1,000 per share, and (ii) the exchange by the Series B Investors of 13,625 shares of our Series A Preferred Stock and 10,670 shares of our Series A-1 Preferred Stock held by them for 31,790 shares of Series B Preferred Stock. Prior to the execution of the Series B Subscription Agreements and the Series B Exchange Agreements, we entered into subscription agreements with certain of the Series B Investors providing for the sale to such investors of 5,670 shares of Series A-1 Preferred Stock, at a purchase price of $1,000 per share, which shares the investors immediately agreed to exchange for shares of Series B Preferred Stock pursuant to the Series B Exchange Agreements (and are included in the 10,670 shares of Series A-1 Preferred Stock set forth above). Each share of the Series B Preferred Stock has a stated value of $1,000 and a conversion price of $1.2444. The terms of the Series B Preferred Stock also include a one times preference on liquidation and a right to receive dividends equal to 20% of the number of shares of our common stock into which such Series B Preferred Stock is convertible, payable on the one-year and two-year anniversary of the issuance date. The holders of the Series B Preferred Stock also will be entitled to dividends equal, on an as-if-converted to shares of common stock basis, to and in the same form as dividends actually paid on shares of the common stock when, as, and if such dividends are paid on shares of the common stock. The Series B Preferred Stock is a voting security. The aggregate gross proceeds of these transactions were $18.16 million (inclusive of $5.67 million of aggregate gross proceeds from the sale of the Series A-1 Preferred Stock that was immediately exchanged for Series B Preferred Stock in the transactions).

 

As a result of 100% of the then-outstanding shares of Series A Preferred Stock and Series A-1 Preferred Stock being exchanged for shares of Series B Preferred Stock in the Series B Offering and Exchange, no shares of Series A Preferred Stock or Series A-1 Preferred Stock remain outstanding.

 

On May 6, 2024, the Company issued approximately 11,634 shares of newly designated Series B-1 Preferred Stock. The terms of the Series B-1 Preferred Stock are substantially identical to the terms of the Series B Preferred Stock, except that the Series B-1 Preferred Stock has a conversion price of $0.7228. The aggregate gross proceeds from the sale of shares in such offering were $11.6 million.

 

Private Placement - Securities Purchase Agreement

 

Effective as of March 13, 2023, we entered into a Securities Purchase Agreement (the “Note SPA”) with an accredited institutional investor, pursuant to which we agreed to sell, and the investor agreed to purchase the March 2023 Senior Convertible Note with a face value principal of $11.1 million. We issued the March 2023 Senior Convertible Note on March 21, 2023 pursuant to the Note SPA. The March 2023 Senior Convertible Note proceeds were $9.925 million after deducting a $1.186 million lender fee and offering costs.

 

31
 

 

Liquidity and Capital Resources - continued

 

The March 2023 Senior Convertible Note has a 7.875% annual stated interest rate, a contractual conversion price of $5.00 per share of the Company’s common stock (subject to standard adjustments in the event of any stock split, stock dividend, stock combination, recapitalization or other similar transaction), and a contractual maturity date of the two-year anniversary of the date of issuance. The principal of the March 2023 Senior Convertible Note and accrued interest thereon is convertible at the option of the holder into the Company’s common stock at the contractual conversion price. In addition, the principal of the March 2023 Senior Convertible Note amortizes over 18 months commencing six months after its issuance. The amortization payments and accrued interest on the March 2023 Senior Convertible Note are payable in shares of the Company’s common stock (subject to the satisfaction of certain customary equity conditions and except for interest payable prior to September 21, 2023), at prices based on the then current market price.

 

Under the March 2023 Senior Convertible Note, the Company is subject to certain customary affirmative and negative covenants regarding the incurrence of indebtedness, the existence of liens, the repayment of indebtedness and the making of investments, the payment of cash in respect of dividends, distributions or redemptions, the transfer of assets, the maturity of other indebtedness, and transactions with affiliates, among other customary matters. Under the March 2023 Senior Convertible Note, the Company is also subject to financial covenants requiring that (i) the amount of the Company’s available cash shall equal or exceed $5.0 million at all times, (ii) the ratio of (a) the outstanding principal amount of the notes issued under the Note SPA, accrued and unpaid interest thereon and accrued and unpaid late charges, as of the last day of any fiscal quarter commencing with September 30, 2023 to (b) the Company’s average market capitalization over the prior ten trading days, shall not exceed 30%, and (iii) the Company’s market capitalization shall at no time be less than $30 million (the “Financial Tests”). As of September 30, 2024, the Company was in compliance, and as of the date hereof, the Company is in compliance, with the Financial Tests.

 

During the nine month period ended September 30, 2024, approximately $2.4 million of principal repayments along with approximately $0.8 million of interest expense thereon, were settled through the issuance of 4,777,898 shares of common stock of the Company, with such shares having a fair value of approximately $4.3 million (with such fair value measured as the respective conversion date quoted closing price of the common stock of the Company).

 

March 2023 Senior Convertible Note Refinancing

 

On November 8, 2024, the Company gave notice to the holder of the March 2023 Senior Convertible Note that it was exercising its right pursuant to such note to redeem the same for the Optional Redemption Price specified in such note. Pursuant to the terms of the March 2023 Senior Convertible Note, the Company has not less than ten business days, and not more than twenty business days, from the date of the notice (which we sometimes refer to as the “Optional Redemption Notice Period”) to pay the Optional Redemption Price.

 

To finance the payment of the Optional Redemption Price, the Company has entered into a securities purchase agreement with the 2024 Note Investors. Under the agreement, subject to customary closing conditions, the Company has agreed to issue, and each 2024 Note Investor has agreed to purchase, the November 2024 Senior Convertible Notes, which are 12.0% senior secured convertible notes due 2029. As of the date hereof, the aggregate commitments of the 2024 Note Investors exceed the Lucid Optional Redemption Price.

 

The Company expects to complete the issuance of the November 2024 Senior Convertible Notes and the redemption of the March 2023 Senior Convertible Note on or prior to the end of the Optional Redemption Notice Period, although there can be no assurance that such issuance and redemption will be completed during such period, if at all

 

32
 

 

Liquidity and Capital Resources - continued

 

The Company expects to complete the issuance of the November 2024 Senior Convertible Notes and the redemption of the March 2023 Senior Convertible Note on or prior to the end of the Optional Redemption Notice Period, although there can be no assurance that such issuance and redemption will be completed during such period, if at all.

 

Committed Equity Facility and ATM Facility

 

In March 2022, we entered into a committed equity facility with a Cantor affiliate. Under the terms of the committed equity facility, the Cantor affiliate has committed to purchase up to $50 million of our common stock from time to time at our request. While there are distinct differences, the committed equity facility is structured similarly to a traditional at-the-market equity facility, insofar as it allows us to raise primary equity capital on a periodic basis at prices based on the existing market price. Cumulatively, a total of 680,263 shares of common stock of the Company have been issued through our committed equity facility for net proceeds of approximately $1.8 million, after a 4% discount, as of September 30, 2024.

 

In November 2022, Lucid Diagnostics also entered into an “at-the-market offering” for up to $6.5 million of its common stock that may be offered and sold under a Controlled Equity Offering Agreement between Lucid Diagnostics and Cantor. Cumulatively, a total of 230,068 shares of the Company have been issued through our at-the-market equity facility for net proceeds of approximately $0.3 million, after payment of 3% commissions, as of September 30, 2024.

 

Intercompany Agreements with PAVmed

 

From our inception in May 2018 through our initial public offering in October 2021, our operations were funded by PAVmed providing working capital cash advances and by PAVmed paying certain operating expenses on our behalf. Additionally, our daily operations have been and continue to be conducted in part by personnel employed by PAVmed, for which we incur an MSA Fee expense. The MSA Fee is charged on a monthly basis and is subject to periodic adjustment corresponding with changes in the services provided by PAVmed personnel to the Company, with any such change in the MSA Fee being subject to approval of the Company and PAVmed boards of directors. In March 2024, PAVmed and the Company were authorized by their respective boards of directors to enter, and they did enter, into a eighth amendment to the MSA. Under this amendment, the monthly fee due from the Company to PAVmed was increased from $750 to $833, effective Janaury 1, 2024. In August 2024, PAVmed and the Company were authorized by their respective boards of directors to enter, and they did enter, into a ninth amendment to the MSA. Under this amendment, the monthly fee due from the Company to PAVmed was increased from $833 to $1,050, effective July 1, 2024. Pursuant to the MSA, as amended, PAVmed may elect to receive payment of the monthly MSA Fee in cash or in shares of our common stock, with such shares valued at the volume weighted average price (“VWAP”) during the final ten trading days of the applicable month (subject to a floor price of $0.70 per share). However, in no event will PAVmed be entitled to receive under the MSA, as amended, from and after the date of the eighth amendment to the MSA, more than 9,644,135 shares of our common stock (representing 19.99% of our outstanding shares of common stock as of immediately prior to the execution of the eighth amendment).

 

As of September 30, 2024, we had a Due To: PAVmed Inc. payment obligation liability of approximately $0.1 million, which liability is primarily comprised of our obligations under a payroll and benefit expense reimbursement agreement (the “PBERA”) and the MSA, as well other operating expenses paid by PAVmed on our behalf. See our accompanying unaudited condensed consolidated financial statements Note 5, Related Party Transactions. In accordance with the MSA and the PBERA, on January 26, 2024, PAVmed elected to receive payment of approximately $4.7 million of fees and reimbursements accrued under the MSA and the PBERA through the issuance of 3,331,771 shares of the Company’s common stock.

 

33
 

 

Critical Accounting Estimates

 

The discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the amounts reporting in our unaudited condensed consolidated financial statements and accompanying notes. On an ongoing basis, we evaluate our estimates and judgements. In accordance with U.S. GAAP, we base our estimates on historical experience and on various other factors that are believed to be appropriate under the circumstances. Actual results may differ from these estimates under different assumptions or conditions. Our critical accounting policies are as disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 as filed with the SEC on March 25, 2024. There have been no material changes to our critical accounting policies and estimates in the nine months ended September 30, 2024.

 

Item 4. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

Our management, with the participation of our principal executive officer and our principal financial officer, evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2024. Based on such evaluation, our principal executive officer and principal financial officer concluded our disclosure controls and procedures (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) were effective as of such date to provide reasonable assurance the information required to be disclosed by us in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure information required to be disclosed by us in the reports we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.

 

Changes to Internal Controls Over Financial Reporting

 

There has been no change in internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during our fiscal quarter ended September 30, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

34
 

 

Part II - Other Information

 

Item 1. Legal Proceedings

 

In the ordinary course of our business, particularly as it begins commercialization of its products, the Company may be subject to certain other legal actions and claims, including product liability, consumer, commercial, tax and governmental matters, which may arise from time to time. The Company is not aware of any such pending legal or other proceedings that are reasonably likely to have a material impact on the Company. Notwithstanding, legal proceedings are subject to inherent uncertainties, and an unfavorable outcome could include monetary damages, and excessive verdicts can result from litigation, and as such, could result in a material adverse impact on the Company’s business, financial position, results of operations, and /or cash flows. Additionally, although the Company has specific insurance for certain potential risks, the Company may in the future incur judgments or enter into settlements of claims which may have a material adverse impact on the Company’s business, financial position, results of operations, and /or cash flows.

 

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

 

On May 29, 2024, the Company approved the issuance to an investor relations firm it had engaged 150,000 unregistered shares of the Company’s common stock. The offer and sale of the shares of common stock is exempt from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”), pursuant to Section 4(a)(2) of the Securities Act, as a transaction not involving a public offering.

 

Except as set forth above and as previously disclosed in our current reports on Form 8-K filed prior to the date of this Form 10-Q and in the Annual Report, we did not sell any unregistered securities or repurchase any of our securities during the three months ended September 30, 2024.

 

See Part I, Item 2 under the caption “Liquidity and Capital Resources” for a description of limitations on the payment of dividends.

 

Item 5. Other Information

 

During the fiscal quarter ended September 30, 2024, none of our directors or officers (as defined in Rule 16a-1 under the Exchange Act) adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement” (as those terms are defined in Item 408 of Regulation S-K).

 

The information set forth in Part I, Item 2 in the first paragraph under the caption “Recent Developments — Business — Intercompany Agreements with PAVmed” is incorporated herein by reference.

 

The information set forth in Part I, Item 2 under the caption “Recent Developments — Financing — March 2023 Senior Convertible Note Refinancing” is incorporated herein by reference.

 

Item 6. Exhibits

 

The exhibits filed as part of this Quarterly Report on Form 10-Q are set forth in the “Exhibit Index” below.

 

35
 

 

SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) 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.

 

  Lucid Diagnostics Inc.
     
November 12, 2024 By: /s/ Dennis M McGrath
    Dennis M McGrath
    Chief Financial Officer
    (Principal Financial and Accounting Officer)

 

36
 

 

EXHIBIT INDEX

 

        Incorporation by Reference
Exhibit No.   Description   Form   Exhibit No.   Date
3.1   Form of Certificate of Designation of Preferences, Rights and Limitations of Series B-1 Preferred Stock.   8-K   3.1   5/7/2024
3.2   Certificate of Amendment to Certificate of Incorporation, dated July 23, 2024.   8-K   3.1   7/23/2024
10.1   Ninth Amendment to Management Services Agreement, dated as of August 6, 2024, by and between PAVmed Inc. and Lucid Diagnostics Inc.   10-Q   10.2   8/12/2024
31.1   Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.   *        
31.2   Certification of Principal Financial and Accounting Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.   *        
32.1   Certification of Principal 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 Principal Financial and Accounting Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.   *        
                 
101.INS   Inline XBRL Instance Document   *        
101.CAL   Inline XBRL Taxonomy Extension Schema   *        
101.DEF   Inline XBRL Taxonomy Extension Calculation Linkbase   *        
101.LAB   Inline XBRL Taxonomy Extension Label Linkbase   *        
101.PRE   Inline XBRL Taxonomy Extension Presentation Linkbase   *        
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)   *        

 

* Filed herewith.

 

37

 

Exhibit 31.1

 

CERTIFICATION BY PRINCIPAL EXECUTIVE OFFICER

 

I, Lishan Aklog, M.D., certify that:

 

1 I have reviewed this Quarterly Report on Form 10-Q of Lucid Diagnostics Inc. and Subsidiaries;
   
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 (the registrant’s fourth fiscal quarter in the case of an annual report) 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 (or persons performing the equivalent functions):

 

  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: November 12, 2024 By: /s/ Lishan Aklog, M.D.
   

Lishan Aklog, M.D., Chief Executive Officer

(Principal Executive Officer)

 

 

 

 

Exhibit 31.2

 

CERTIFICATION BY PRINCIPAL FINANCIAL OFFICER

 

I, Dennis M. McGrath, certify that:

 

1 I have reviewed this Quarterly Report on Form 10-Q of Lucid Diagnostics Inc. and Subsidiaries;
   
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 (the registrant’s fourth fiscal quarter in the case of an annual report) 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 (or persons performing the equivalent functions):

 

  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: November 12, 2024 By: /s/ Dennis M. McGrath
   

Dennis M. McGrath

Chief Financial Officer

(Principal Financial and 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 on Form 10-Q of Lucid Diagnostics Inc. and Subsidiaries (the “Company”) for the quarter ended September 30, 2024 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned, Lishan Aklog, M.D., Chief Executive Officer of the Company, hereby certifies, pursuant to 18 U.S.C. Section 1350, that to his knowledge:

 

(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: November 12, 2024 By: /s/ Lishan Aklog, M.D.
   

Lishan Aklog, 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 on Form 10-Q of Lucid Diagnostics Inc. and Subsidiaries (the “Company”) for the quarter ended September 30, 2024 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned, Dennis M. McGrath, President and Chief Financial Officer of the Company, hereby certifies, pursuant to 18 U.S.C. Section 1350, that to his knowledge:

 

(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: November 12, 2024 By: /s/ Dennis M. McGrath
   

Dennis M. McGrath

Chief Financial Officer

(Principal Financial and Accounting Officer)

 

 

 

 

v3.24.3
Cover - $ / shares
9 Months Ended
Sep. 30, 2024
Nov. 08, 2024
Cover [Abstract]    
Document Type 10-Q  
Amendment Flag false  
Document Quarterly Report true  
Document Transition Report false  
Document Period End Date Sep. 30, 2024  
Document Fiscal Period Focus Q3  
Document Fiscal Year Focus 2024  
Current Fiscal Year End Date --12-31  
Entity File Number 001-40901  
Entity Registrant Name LUCID DIAGNOSTICS INC.  
Entity Central Index Key 0001799011  
Entity Tax Identification Number 82-5488042  
Entity Incorporation, State or Country Code DE  
Entity Address, Address Line One 360 Madison Avenue  
Entity Address, Address Line Two 25th Floor  
Entity Address, City or Town New York  
Entity Address, State or Province NY  
Entity Address, Postal Zip Code 10017  
City Area Code (917)  
Local Phone Number 813-1828  
Title of 12(b) Security Common Stock, $0.001 par value per share  
Trading Symbol LUCD  
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  
Elected Not To Use the Extended Transition Period false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding 55,495,158 59,342,479
Entity Listing, Par Value Per Share $ 0.001  
v3.24.3
Condensed Consolidated Balance Sheets (Unaudited) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Current assets:    
Cash $ 14,489 $ 18,896
Accounts receivable 39 45
Inventory 651 278
Prepaid expenses, deposits, and other current assets 1,645 2,854
Total current assets 16,824 22,073
Fixed assets, net 940 1,334
Operating lease right-of-use assets 2,860 1,307
Intangible assets, net 842 1,424
Other assets 1,132 1,132
Total assets 22,598 27,270
Current liabilities:    
Accounts payable 1,135 1,146
Accrued expenses and other current liabilities 2,006 3,841
Operating lease liabilities, current portion 855 1,106
Senior Secured Convertible Note - at fair value 10,200 13,950
Due To: PAVmed Inc. - MSA Fee and operating expenses 53 9,339
Total current liabilities 14,249 29,382
Operating lease liabilities, less current portion 2,011 199
Total liabilities 16,260 29,581
Commitments and contingencies
Stockholders’ Equity:    
Preferred stock, $0.001 par value, 20,000,000 shares authorized; Series B and Series B-1 Convertible Preferred Stock, issued and outstanding 55,919 at September 30, 2024 and Series A and Series A-1 Convertible Preferred Stock, shares issued and outstanding 18,625 at December 31, 2023 55,919 18,625
Common stock, $0.001 par value, 300,000,000 and 200,000,000 shares authorized as of September 30, 2024 and December 31, 2023, respectively; 51,597,718 and 42,329,864 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively 52 42
Additional paid-in capital 142,592 129,763
Accumulated deficit (192,225) (150,741)
Total Stockholders’ Equity (Deficit) 6,338 (2,311)
Total Liabilities and Stockholders’ Equity (Deficit) $ 22,598 $ 27,270
v3.24.3
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares
Sep. 30, 2024
Dec. 31, 2023
Preferred stock, par value $ 0.001 $ 0.001
Preferred stock, shares authorized 20,000,000 20,000,000
Common stock, par value $ 0.001 $ 0.001
Common stock, shares authorized 300,000,000 200,000,000
Common stock, shares issued 51,597,718 42,329,864
Common stock, shares outstanding 51,597,718 42,329,864
Series B Preferred Stock [Member]    
Preferred stock, shares issued 55,919  
Preferred stock, shares outstanding 55,919  
Series B-1 Preferred Stock [Member]    
Preferred stock, shares issued 55,919  
Preferred stock, shares outstanding 55,919  
Series A Preferred Stock [Member]    
Preferred stock, shares issued   18,625
Preferred stock, shares outstanding   18,625
Series A-1 Preferred Stock [Member]    
Preferred stock, shares issued   18,625
Preferred stock, shares outstanding   18,625
v3.24.3
Condensed Consolidated Statements of Operations (Unaudited) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Income Statement [Abstract]        
Revenue $ 1,172 $ 783 $ 3,149 $ 1,388
Operating expenses:        
Cost of revenue 1,684 1,634 4,954 4,522
Sales and marketing 4,056 3,837 12,459 11,996
General and administrative 5,355 4,320 14,292 15,049
Amortization of acquired intangible assets 105 505 582 1,516
Research and development 1,666 1,615 4,539 5,334
Total operating expenses 12,866 11,911 36,826 38,417
Operating loss (11,694) (11,128) (33,677) (37,029)
Other income (expense):        
Interest income 81 116 256 330
Interest expense (1) (149) (19) (405)
Change in fair value - Senior Secured Convertible Note (322) (3,021) 568 (3,520)
Loss on issue and offering costs - Senior Secured Convertible Note (1,186)
Debt extinguishments loss - Senior Secured Convertible Note (435) (26) (1,116) (26)
Other income (expense), net (677) (3,080) (311) (4,807)
Loss before provision for income tax (12,371) (14,208) (33,988) (41,836)
Provision for income taxes
Net loss attributable to Lucid Diagnostics Inc. (12,371) (14,208) (33,988) (41,836)
Less: Deemed dividend on Series A and Series A-1 Convertible Preferred Stock (7,496)
Net loss attributable to Lucid Diagnostics Inc. common stockholders $ (12,371) $ (14,208) $ (41,484) $ (41,836)
Net loss per share - basic [1] $ (0.25) $ (0.34) $ (0.87) $ (1.01)
Net loss per share - diluted [1] $ (0.25) $ (0.34) $ (0.87) $ (1.01)
Weighted average common shares outstanding, basic 50,374,146 41,862,805 47,876,015 41,558,979
Weighted average common shares outstanding, diluted 50,374,146 41,862,805 47,876,015 41,558,979
[1] - Convertible Preferred Stock would potentially be considered a participating security under the two-class method of calculating net loss per share. However, the Company has incurred net losses to-date, and as such holders are not contractually obligated to share in the losses, there is no impact on the Company’s net loss per share calculation for the periods indicated.
v3.24.3
Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit) (Unaudited) - USD ($)
$ in Thousands
Preferred Stock [Member]
Common Stock [Member]
Additional Paid-in Capital [Member]
Retained Earnings [Member]
Total
Balance at Dec. 31, 2022 $ 41 $ 121,081 $ (98,075) $ 23,047
Balance, shares at Dec. 31, 2022 40,518,792      
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan 5,014 5,014
Stock-based compensation - PAVmed Inc. 2014 Equity Plan 845 845
Conversions - Senior Secured Convertible Note 166 166
Conversions - Senior Secured Convertible Note, shares   115,388      
Purchase - Employee Stock Purchase Plan 551 551
Purchase - Employee Stock Purchase Plan, shares   508,200      
Net loss (41,836) (41,836)
Vest - restricted stock awards
Vest - restricted stock awards, shares   303,980      
Issue common stock - vendor service agreement 147 147
Issue common stock - vendor service agreement, shares   100,000      
Issuance common stock - APA-RDx - Termination payment 713 713
Issuance common stock - APA-RDx - Termination payment, shares   553,436      
Issuance - At-The-Market Facility, net of financing charges $ 1 283 284
Issuance - At-The-Market Facility, net of financing charges, shares   230,068      
Issuance - Series A Preferred Stock $ 13,625 13,625
Issuance - Series A Preferred Stock, shares 13,625        
Balance at Sep. 30, 2023 $ 13,625 $ 42 128,800 (139,911) 2,556
Balance, shares at Sep. 30, 2023 13,625 42,329,864      
Balance at Jun. 30, 2023 $ 13,625 $ 42 127,107 (125,703) 15,071
Balance, shares at Jun. 30, 2023 13,625 41,853,603      
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan 1,032 1,032
Stock-based compensation - PAVmed Inc. 2014 Equity Plan 220 220
Conversions - Senior Secured Convertible Note 166 166
Conversions - Senior Secured Convertible Note, shares   115,388      
Purchase - Employee Stock Purchase Plan 275 275
Purchase - Employee Stock Purchase Plan, shares   276,213      
Net loss (14,208) (14,208)
Exercise - stock options - Lucid Diagnostics Inc. 2018 Equity Plan
Vest - restricted stock awards
Vest - restricted stock awards, shares   84,660      
Issue common stock - vendor service agreement
CapNostics, LLC
APA-RDx - Installment Payment
Issuance - Committed Equity Facility, net of deferred financing charges
Balance at Sep. 30, 2023 $ 13,625 $ 42 128,800 (139,911) 2,556
Balance, shares at Sep. 30, 2023 13,625 42,329,864      
Balance at Dec. 31, 2023 $ 18,625 $ 42 129,763 (150,741) (2,311)
Balance, shares at Dec. 31, 2023 18,625 42,329,864      
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan 3,034 3,034
Stock-based compensation - PAVmed Inc. 2014 Equity Plan 329 329
Conversions - Senior Secured Convertible Note $ 6 4,293 4,299
Conversions - Senior Secured Convertible Note, shares   4,777,898      
Purchase - Employee Stock Purchase Plan $ 1 446 447
Purchase - Employee Stock Purchase Plan, shares   647,940      
Transfer of intellectual property from PAVmed Inc. (350) (350)
Net loss         (33,988)
Exercise - stock options - Lucid Diagnostics Inc. 2018 Equity Plan 4 $ 4
Exercise - stock options - Lucid Diagnostics Inc. 2018 Equity Plan, shares   3,333     3,333
Vest - restricted stock awards
Vest - restricted stock awards, shares   26,912      
Issuance - Series A-1 Preferred Stock $ 5,670 5,670
Issuance - Series A-1 Preferred Stock, shares 5,670        
Exchange - Series A and Series A-1 Preferred Stock $ (24,295) (7,496) (31,791)
Exchange - Series A and Series A-1 Preferred Stock, shares (24,295)        
Issuance through exchange - Series B and Series B-1 Preferred Stock $ 31,790 31,790
Issuance through exchange - Series B and Series B-1 Preferred Stock, shares 31,790        
Issuance through sale- Series B and Series B-1 Preferred Stock $ 24,129 24,129
Issuance through sale- Series B and Series B-1 Preferred Stock, shares 24,129        
Issuance - Due To: PAVmed Inc. Settlement in Common Stock $ 3 4,672 4,675
Issuance - Due To: PAVmed Inc. Settlement in Common Stock, shares   3,331,771      
Issue common stock - vendor service agreement   401 $ 401
Issue common stock - vendor service agreement, shares   480,000     480,000
Balance at Sep. 30, 2024 $ 55,919 $ 52 142,592 (192,225) $ 6,338
Balance, shares at Sep. 30, 2024 55,919 51,597,718      
Balance at Jun. 30, 2024 $ 55,919 $ 49 139,865 (179,854) 15,979
Balance, shares at Jun. 30, 2024 55,919 49,344,945      
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan 1,185 1,185
Stock-based compensation - PAVmed Inc. 2014 Equity Plan 43 43
Conversions - Senior Secured Convertible Note $ 3 1,755 1,758
Conversions - Senior Secured Convertible Note, shares   2,116,717      
Purchase - Employee Stock Purchase Plan 94 94
Purchase - Employee Stock Purchase Plan, shares   136,056      
Transfer of intellectual property from PAVmed Inc. (350) (350)
Net loss (12,371) (12,371)
Balance at Sep. 30, 2024 $ 55,919 $ 52 $ 142,592 $ (192,225) $ 6,338
Balance, shares at Sep. 30, 2024 55,919 51,597,718      
v3.24.3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
$ in Thousands
9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Cash flows from operating activities    
Net loss $ (33,988) $ (41,836)
Adjustments to reconcile net loss to net cash used in operating activities    
Depreciation and amortization expense 945 1,870
Stock-based compensation - Lucid Diagnostics Inc. 2018 Equity Plan 3,034 5,014
Stock-based compensation - PAVmed Inc. 2014 Equity Plan 329 845
Change in fair value - Senior Secured Convertible Note (568) 3,520
Loss on issue - Senior Secured Convertible Note 1,111
Debt extinguishment loss - Senior Secured Convertible Note 1,116 26
APA-RDx: Issue common stock - termination payment 713
Amortization of common stock payment for vendor service agreement 248 23
Changes in operating assets and liabilities:    
Accounts receivable 7 (4)
Prepaid expenses and other current assets 1,065 (1,262)
Accounts payable (10) (62)
Accrued expenses and other current liabilities (1,836) 1,878
Due To: PAVmed Inc. - operating expenses, employee related costs, MSA Fee (4,611) 5,326
Net cash flows used in operating activities (34,269) (22,838)
Cash flows from investing activities    
Purchase of equipment (37) (46)
Purchase of intellectual property from PAVmed Inc. (350)
Net cash flows used in investing activities (387) (46)
Cash flows from financing activities    
Proceeds – issue of preferred stock 29,798 13,625
Proceeds – issue of Senior Convertible Note 10,000
Proceeds – issue of common stock – At-The-Market Facility 284
Proceeds – exercise of stock options 4
Proceeds – issue common stock – Employee Stock Purchase Plan 447 551
Net cash flows provided by financing activities 30,249 24,460
Net increase (decrease) in cash (4,407) 1,576
Cash, beginning of period 18,896 22,474
Cash, end of period $ 14,489 $ 24,050
v3.24.3
Pay vs Performance Disclosure - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Pay vs Performance Disclosure [Table]        
Net Income (Loss) $ (12,371) $ (14,208) $ (33,988) $ (41,836)
v3.24.3
Insider Trading Arrangements
3 Months Ended
Sep. 30, 2024
Insider Trading Arrangements [Line Items]  
Rule 10b5-1 Arrangement Adopted false
Non-Rule 10b5-1 Arrangement Adopted false
Rule 10b5-1 Arrangement Terminated false
Non-Rule 10b5-1 Arrangement Terminated false
v3.24.3
The Company
9 Months Ended
Sep. 30, 2024
Accounting Policies [Abstract]  
The Company

Note 1 — The Company

 

Description of the Business

 

Lucid Diagnostics Inc. (“Lucid”, “Lucid Diagnostics” or the “Company”) is a commercial-stage, cancer prevention medical diagnostics technology company focused on the millions of patients with gastroesophageal reflux disease (“GERD”), also known as chronic heartburn, acid reflux or simply reflux, who are at risk of developing esophageal precancer and cancer, specifically highly lethal esophageal adenocarcinoma (“EAC”). Lucid is a non-consolidated subsidiary of PAVmed Inc. (“PAVmed”).

 

The Company believes that its flagship product, the EsoGuard Esophageal DNA Test, performed on samples collected with the EsoCheck Esophageal Cell Collection Device, constitutes the first and only commercially available diagnostic test capable of serving as a widespread testing tool for the early detection of esophageal precancer in at-risk GERD patients.

 

EsoGuard is a bisulfite-converted next-generation sequencing (NGS) DNA assay performed on surface esophageal cells collected with EsoCheck. Cell samples, including those collected with EsoCheck, as discussed below, are sent to our laboratory, for testing and analyses using our proprietary EsoGuard NGS DNA assay.

 

EsoCheck is a FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells in a less than a five-minute office procedure. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from which a soft silicone balloon with textured ridges emerges, when inflated, to gently swab surface esophageal cells. When vacuum suction is applied, the balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted region during device withdrawal. The Company believes that this proprietary Collect+Protect™ technology makes EsoCheck the only noninvasive esophageal cell collection device capable of such anatomically targeted and protected sampling.

 

EsoGuard and EsoCheck are based on patented technology licensed by Lucid from Case Western Reserve University (“CWRU”). EsoGuard and EsoCheck have been developed to provide an accurate, non-invasive, patient-friendly test for the early detection of EAC and Barrett’s Esophagus (“BE”), including dysplastic BE and related precursors to EAC in patients with chronic GERD.

 

v3.24.3
Liquidity and Going Concern
9 Months Ended
Sep. 30, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Liquidity and Going Concern

Note 2 — Liquidity and Going Concern

 

The Company’s management is required to assess an entity’s ability to continue as a going concern within one year of the date of the financial statements being issued. In each reporting period, including interim periods, an entity is required to assess conditions known and reasonably knowable as of the financial statement issuance date to determine whether it is probable an entity will not meet its financial obligations within one year from the financial statement issuance date. Substantial doubt about an entity’s ability to continue as a going concern exists when conditions and events, considered in the aggregate, indicate it is probable the entity will be unable to meet its financial obligations as they become due within one year after the date the financial statements are issued.

 

The Company has financed its operations principally through public and private issuances of its common stock, preferred stock, and debt. The Company is subject to all of the risks and uncertainties typically faced by medical device and diagnostic companies that devote substantially all of their efforts to the commercialization of their initial product and services and ongoing research and development activities and conducting clinical trials. The Company generated $1.2 million and $3.1 million of revenues for the three and nine month periods ended September 30, 2024, respectively, however the Company expects to continue to experience recurring losses and to generate negative cash flows from operating activities in the near future.

 

The Company incurred a net loss attributable to Lucid Diagnostics Inc common stockholders of approximately $41.5 million and had net cash flows used in operating activities of approximately $34.3 million for the nine month period ended September 30, 2024. As of September 30, 2024, the Company had working capital of approximately $2.6 million, with such working capital inclusive of the Senior Secured Convertible Note classified as a current liability of approximately $10.2 million and approximately $14.5 million of cash.

 

The Company’s ability to continue operations 12 months beyond the issuance of the financial statements, will depend upon generating substantial revenue that is conditioned upon obtaining positive third-party reimbursement coverage for its EsoGuard Esophageal DNA Test from both government and private health insurance providers, increasing revenue through contracting directly with self-insured employers, and on its ability to raise additional capital through various potential sources including equity and/or debt financings or refinancing existing debt obligations. These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the accompanying unaudited condensed consolidated financial statements are issued.

 

 

v3.24.3
Summary of Significant Accounting Policies
9 Months Ended
Sep. 30, 2024
Accounting Policies [Abstract]  
Summary of Significant Accounting Policies

Note 3 — Summary of Significant Accounting Policies

 

Significant Accounting Policies

 

The Company’s significant accounting policies are as disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 as filed with the SEC on March 25, 2024, except as otherwise noted herein below.

 

Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements of the Company and its subsidiaries have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”), and applicable rules and regulations of the United States Securities and Exchange Commission (“SEC”), and include the accounts of the Company and its wholly-owned subsidiaries. All intercompany transactions and balances have been eliminated in consolidation. The Company is a non-consolidated subsidiary of PAVmed, which has the ability to exercise significant influence over the Company. The Company manages its operations as a single operating segment for the purposes of assessing performance and making operating decisions.

 

As permitted under SEC rules, certain footnotes or other financial information normally required by U.S. GAAP have been condensed or omitted. The balance sheet as of December 31, 2023 has been derived from audited consolidated financial statements at such date. The accompanying unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements, and in the opinion of management, include all adjustments, consisting only of routine recurring adjustments, necessary for a fair statement of the Company’s unaudited condensed consolidated financial information.

 

The unaudited condensed consolidated results of operations for the three and nine months ended September 30, 2024 are not necessarily indicative of the consolidated results to be expected for the year ending December 31, 2024 or for any other interim period or for any other future periods. The accompanying unaudited condensed consolidated financial statements and related unaudited condensed consolidated financial information should be read in conjunction with the Company’s audited consolidated financial statements and related notes thereto as of and for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K as filed with the SEC on March 25, 2024.

 

All amounts in the accompanying unaudited condensed consolidated financial statements and the notes thereto are presented in thousands of dollars, if not otherwise noted as being presented in millions of dollars, except for shares and per share amounts.

 

Use of Estimates

 

In preparing the unaudited condensed consolidated financial statements in conformity with U.S. GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and the determination of corresponding carrying value reserves, if any, and liabilities and the disclosure of contingent losses, as of the date of the unaudited condensed consolidated financial statements, as well as the reported amounts of revenue and expenses during the reporting period. Significant estimates in these unaudited condensed consolidated financial statements include those related to the estimated fair value of debt obligations, stock-based equity awards and intangible assets. Other significant estimates include the estimated incremental borrowing rate, the provision or benefit for income taxes and the corresponding valuation allowance on deferred tax assets. Additionally, management’s assessment of the Company’s ability to continue as a going concern involves the estimation of the amount and timing of future cash inflows and outflows. On an ongoing basis, the Company evaluates its estimates and assumptions. The Company bases its estimates on historical experience and on various other assumptions believed to be reasonable. Due to inherent uncertainty involved in making estimates, actual results reported in future periods may be affected by changes in these estimates.

 

Revenue Recognition

 

Revenues are recognized when the satisfaction of the performance obligation occurs, in an amount that reflects the consideration the Company expects to collect in exchange for those services. The Company’s revenue is primarily generated by its laboratory testing services utilizing its EsoGuard Esophageal DNA tests. The services are completed upon release of a patient’s test result to the ordering healthcare provider. Revenue recognized is inclusive of both variable consideration in connection with an individual patient’s third-party insurance coverage policy and fixed consideration in connection with a contracted services arrangement with an unrelated third party legal entity. To determine revenue recognition for the arrangements that the Company determines are within the scope of ASC 606, Revenue from Contracts with Customers, the Company performs the following five steps: (1) identify the contract(s) with a customer, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract and (5) recognize revenue when (or as) the entity satisfies a performance obligation.

 

 

Note 3 — Summary of Significant Accounting Policies - continued

 

The key aspects considered by the Company include the following:

 

Contracts—The Company’s customer is primarily the patient, but the Company does not enter into a formal reimbursement contract with a patient. The Company establishes a contract with a patient in accordance with other customary business practices, which is the point in time an order is received from a provider and a patient specimen has been returned to the laboratory for testing. Payment terms are a function of a patient’s existing insurance benefits, including the impact of coverage decisions with Center for Medicare & Medicaid Services (“CMS”) and applicable reimbursement contracts established between the Company and payers. However, when a patient is considered self-pay, the Company requires payment from the patient prior to the commencement of the Company’s performance obligations. The Company’s consideration can be deemed variable or fixed depending on the structure of specific payer contracts, and the Company considers collection of such consideration to be probable to the extent that it is unconstrained.

 

Performance obligations—A performance obligation is a promise in a contract to transfer a distinct good or service (or a bundle of goods or services) to the customer. The Company’s contracts have a single performance obligation, which is satisfied upon rendering of services, which culminates in the release of a patient’s test result to the ordering healthcare provider. The Company elects the practical expedient related to the disclosure of unsatisfied performance obligations, as the duration of time between providing testing supplies, the receipt of a sample, and the release of a test result to the ordering healthcare provider is far less than one year.

 

Transaction price—The transaction price is the amount of consideration that the Company expects to collect in exchange for transferring promised goods or services to a customer, excluding amounts collected on behalf of third parties (for example, some sales taxes). The consideration expected to be collected from a contract with a customer may include fixed amounts, variable amounts, or both.

 

If the consideration derived from the contracts is deemed to be variable, the Company estimates the amount of consideration to which it will be entitled in exchange for the promised goods or services. The Company limits the amount of variable consideration included in the transaction price to the unconstrained portion of such consideration. In other words, the Company recognizes revenue up to the amount of variable consideration that is not subject to a significant reversal until additional information is obtained or the uncertainty associated with the additional payments or refunds is subsequently resolved.

 

When the Company does not have significant historical experience or that experience has limited predictive value, the constraint over estimates of variable consideration may result in no revenue being recognized upon delivery of patient EsoGuard test results to the ordering healthcare provider. As such, the Company recognizes revenue up to the amount of variable consideration not subject to a significant reversal until additional information is obtained or the uncertainty associated with additional payments or refunds, if any, is subsequently resolved. Differences between original estimates and subsequent revisions, including final settlements, represent changes in estimated expected variable consideration, with the change in estimate recognized in the period of such revised estimate. With respect to a contracted service arrangement, the fixed consideration revenue is recognized on an as-billed basis upon delivery of the laboratory test report with realization of such fixed consideration deemed probable based upon actual historical experience.

 

Allocate transaction price—The transaction price is allocated entirely to the performance obligation contained within the contract with a customer on the basis of the relative standalone selling prices of each distinct good or service.

 

Practical Expedients—The Company does not adjust the transaction price for the effects of a significant financing component, as at contract inception, the Company expects the collection cycle to be one year or less.

 

Fair Value Option (“FVO”) Election

 

Under a Securities Purchase Agreement dated March 13, 2023, the Company issued a Senior Secured Convertible Note dated March 21, 2023, referred to herein as the “March 2023 Senior Convertible Note”, which is accounted under the “fair value option election” as discussed below.

 

Under Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 815, Derivative and Hedging, (“ASC 815”), a financial instrument containing embedded features and/or options may be required to be bifurcated from the financial instrument host and recognized as separate derivative asset or liability, with the bifurcated derivative asset or liability initially measured at estimated fair value as of the transaction issue date and then subsequently remeasured at estimated fair value as of each reporting period balance sheet date.

 

Alternatively, FASB ASC Topic 825, Financial Instruments, (“ASC 825”) provides for the “fair value option” (“FVO”) election. In this regard, ASC 825-10-15-4 provides for the FVO election (to the extent not otherwise prohibited by ASC 825-10-15-5) to be afforded to financial instruments, wherein the financial instrument is initially measured at estimated fair value as of the transaction issue date and then subsequently remeasured at estimated fair value as of each reporting period balance sheet date, with changes in the estimated fair value recognized as other income (expense) in the statement of operations. The estimated fair value adjustment of the March 2023 Senior Convertible Note, including the component related to accrued interest, is presented in a single line item within other income (expense) in the accompanying unaudited condensed consolidated statement of operations (as provided for by ASC 825-10-50-30(b)). Further, as required by ASC 825-10-45-5, to the extent a portion of the fair value adjustment is attributed to a change in the instrument-specific credit risk, such portion would be recognized as a component of other comprehensive income (“OCI”) (for which there was no such adjustment with respect to the March 2023 Senior Convertible Note).

 

See Note 9, Financial Instruments Fair Value Measurements, with respect to the FVO election; and Note 10, Debt, for a discussion of the March 2023 Senior Convertible Note.

 

 

Note 3 — Summary of Significant Accounting Policies - continued

 

Recent Accounting Standards Updates Not Yet Adopted

 

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740)—Improvements to Income Tax Disclosures (“ASU 2023-09”), which is intended to enhance the transparency and decision usefulness of income tax disclosures. The amendments in ASU 2023-09 provide for enhanced income tax information primarily through changes to the rate reconciliation and income taxes paid information. ASU 2023-09 is effective for the Company prospectively to all annual periods beginning after December 15, 2024. Early adoption is permitted. The Company does not expect the standard to have a significant impact on its unaudited condensed consolidated financial statements.

 

In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280)—Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which require public companies disclose significant segment expenses and other segment items on an annual and interim basis and to provide in interim periods all disclosures about a reportable segment’s profit or loss and assets that are currently required annually. The guidance is effective for public entities for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. The guidance is applied retrospectively to all periods presented in the financial statements, unless it is impracticable. The Company is currently evaluating the impact this update will have on its unaudited condensed consolidated financial statements and disclosures, however the company does not expect the standard to have a significant impact.

 

In October 2023, the FASB issued ASU No. 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative. This update modifies the disclosure or presentation requirements of a variety of topics in the Accounting Standards Codification to conform with certain SEC amendments in Release No. 33-10532, Disclosure Update and Simplification. The amendments in this update should be applied prospectively, and the effective date for each amendment will be the date on which the SEC’s removal of that related disclosure from Regulation S-X or S-K becomes effective. However, if the SEC has not removed the related disclosure from its regulations by June 30, 2027, the amendments will be removed from the Codification and not become effective. Early adoption is prohibited. The Company is currently evaluating the impact this update will have on its unaudited condensed consolidated financial statements and disclosures.

 

v3.24.3
Revenue from Contracts with Customers
9 Months Ended
Sep. 30, 2024
Revenue from Contract with Customer [Abstract]  
Revenue from Contracts with Customers

Note 4 — Revenue from Contracts with Customers

 

Revenue Recognized

 

In the three and nine month periods ended September 30, 2024, the Company recognized revenue of $1,172 and $3,149, respectively, resulting from the delivery of patient EsoGuard test results. Revenue recognized from customer contracts deemed to include a variable consideration transaction price is limited to the unconstrained portion of the variable consideration. The Company’s revenue for the three and nine month periods ended September 30, 2023 was $783 and $1,388, respectively, resulting from the delivery of patient EsoGuard test results.

 

Cost of Revenue

 

The cost of revenues principally includes the costs related to the Company’s laboratory operations (excluding estimated costs associated with research activities), the costs related to the EsoCheck cell collection device, cell sample mailing kits and license royalties.

 

In the three and nine month periods ended September 30, 2024, the cost of revenue was $1,684 and $4,954, respectively, primarily related to costs for our laboratory operations and EsoCheck device supplies. The Company’s cost of revenue for the three and nine month periods ended September 30, 2023 was $1,634 and $4,522, respectively, primarily related to costs for our laboratory operations and EsoCheck device supplies.

 

 

v3.24.3
Related Party Transactions
9 Months Ended
Sep. 30, 2024
Related Party Transactions [Abstract]  
Related Party Transactions

Note 5 — Related Party Transactions

 

The aggregate Due To: PAVmed Inc. for the period indicated is summarized as follows:

 

                 
   MSA Fees   Employee-Related Costs   PAVmed Inc. OBO Payments   Total 
Balance - December 31, 2023  $6,150   $3,163   $26   $9,339 
MSA fees   8,150            8,150 
ERC - Benefits       1,411        1,411 
On Behalf Of (OBO) activities           598    598 
Cash payments to PAVmed Inc.   (12,650)   (1,537)   (583)   (14,770)
Payment to PAVmed Inc. settled in LUCD stock   (1,650)   (3,025)       (4,675)
Balance - September 30, 2024  $   $12   $41   $53 

 

PAVmed - Management Services Agreement

 

The Company’s daily operations are also managed in part by personnel employed by PAVmed, for which the Company incurs a service fee, referred to as the “MSA Fee”, according to the provisions of a Management Services Agreement (“MSA”) with PAVmed. The MSA does not have a termination date, but may be terminated by the Company’s board of directors. The MSA Fee is charged on a monthly basis and is subject-to periodic adjustment corresponding with changes in the services provided by PAVmed personnel to the Company, with any such change in the MSA Fee being subject to approval of the boards of directors of each of the Company and PAVmed. In March 2024, PAVmed and the Company were authorized by their respective boards of directors to enter, and they did enter, into an eighth amendment to the MSA. Under this amendment, the monthly fee due from the Company to PAVmed was increased from $750 to $833, effective January 1, 2024. In August 2024, PAVmed and the Company were authorized by their respective boards of directors to enter, and they did enter, into a ninth amendment to the MSA. Under this amendment, the monthly fee due from the Company to PAVmed was increased from $833 to $1,050, effective July 1, 2024. During the nine months ended September 30, 2023, MSA fees were $750 per month.

 

On January 26, 2024, PAVmed elected to receive payment of $4,675 of fees and reimbursements due from Lucid, through the issuance of 3,331,771 shares of Lucid Diagnostics common stock.

 

The MSA Fee expense classification in the unaudited condensed consolidated statement of operations for the periods noted is as follows:

 

   2024   2023   2024   2023 
  

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

 
   2024   2023   2024   2023 
Sales & Marketing   164    109   $417   $218 
General & Administrative   2,253    1,554    5,860    3,108 
Research & Development   733    587    1,873    1,174 
Total MSA Fee  $3,150   $2,250   $8,150   $4,500 

 

The classification of the MSA Fee as presented above is based on the PAVmed classification of employee salary expense and other operating expenses. In this regard, PAVmed classifies employee salary expense as sales and marketing expenses for employees performing sales, sales support and marketing activities, research and development expenses for those employees who are engaged in product and services engineering development and design and /or clinical trials activities, and other employees and activities classified as general and administrative.

 

Transfer of Intellectual Property from PAVmed

 

On September 27, 2024, the Company entered into an Assignment of Patent Rights with PAVmed, pursuant to which PAVmed assigned certain patent rights to the Company related to the EsoCheck device. In consideration of the assignment the Company agreed to pay PAVmed a $350 assignment fee.

 

v3.24.3
Prepaid Expenses, Deposits, and Other Current Assets
9 Months Ended
Sep. 30, 2024
Prepaid Expenses Deposits And Other Current Assets  
Prepaid Expenses, Deposits, and Other Current Assets

Note 6 — Prepaid Expenses, Deposits, and Other Current Assets

 

Prepaid expenses and other current assets consisted of the following as of:

 

   September 30, 2024   December 31, 2023 
Advanced payments to service providers and suppliers  $389   $266 
Prepaid insurance   49    607 
Deposits   1,207    1,981 
Total prepaid expenses, deposits and other current assets  $1,645   $2,854 

 

 

v3.24.3
Leases
9 Months Ended
Sep. 30, 2024
Leases  
Leases

Note 7 — Leases

 

During the nine months ended September 30, 2024, the Company entered into additional lease agreements that have commenced and are classified as operating leases, including in June 2024, the Company exercised a renewal option to extend the lease term on its central laboratory in California for an additional three years, through December 31, 2027. The aggregate (undiscounted) rent payments are approximately $2.6 million over the extended lease term.

 

The Company’s future lease payments as of September 30, 2024, which are presented as operating lease liabilities, current portion and operating lease liabilities, less current portion on the Company’s unaudited condensed consolidated balance sheets are as follows:

 

      
2024 (remainder of year)  $266 
2025   1,025 
2026   979 
2027   940 
2028   19 
Total lease payments  $3,229 
Less: imputed interest   (363)
Present value of lease liabilities  $2,866 

 

Supplemental disclosure of cash flow information related to the Company’s cash and non-cash activities with its leases are as follows:

 

   2024   2023 
   Nine Months Ended September 30, 
   2024   2023 
Cash paid for amounts included in the measurement of lease liabilities          
Operating cash flows from operating leases  $889   $894 
Non-cash investing and financing activities          
Right-of-use assets obtained in exchange for new operating lease liabilities  $2,347   $380 
Weighted-average remaining lease term - operating leases (in years)   3.17    1.58 
Weighted-average discount rate - operating leases   7.875%   7.875%

 

As of September 30, 2024 and December 31, 2023, the Company’s right-of-use assets from operating leases were $2,860 and $1,307, respectively, which are reported in operating lease right-of-use assets in the unaudited condensed consolidated balance sheets. As of September 30, 2024 and December 31, 2023, the Company had outstanding operating lease obligations of $2,866 and $1,305, respectively, of which $855 and $1,106, respectively, are reported in operating lease liabilities, current portion and $2,011 and $199, respectively, are reported in operating lease liabilities less current portion in the Company’s unaudited condensed consolidated balance sheets. The Company calculates its incremental borrowing rates for specific lease terms, used to discount future lease payments, as a function of the financing terms the Company would likely receive on the open market.

 

 

v3.24.3
Intangible Assets, net
9 Months Ended
Sep. 30, 2024
Goodwill and Intangible Assets Disclosure [Abstract]  
Intangible Assets, net

Note 8 — Intangible Assets, net

 

Intangible assets, less accumulated amortization, consisted of the following as of:

 

   Estimated Useful Life  September 30, 2024   December 31, 2023 
Defensive technology  60 months  $2,105   $2,105 
Laboratory licenses and certifications and laboratory information management software  24 months   3,200   $3,200 
Total Intangible assets      5,305    5,305 
Less Accumulated Amortization      (4,463)   (3,881)
Intangible Assets, net     $842   $1,424 

 

Amortization expense of the intangible assets discussed above was $105 and $505 for the three month periods ended September 30, 2024 and 2023, respectively, and $582 and $1,516 for the nine month periods ended September 30, 2024 and 2023, respectively, and is included in amortization of acquired intangible assets in the accompanying unaudited condensed consolidated statements of operations. As of September 30, 2024, the estimated future amortization expense associated with the Company’s finite-lived intangible assets for each of the five succeeding fiscal years is as follows:

 

      
2024 (remainder of year)  $105 
2025   421 
2026   316 
Total  $842 

 

v3.24.3
Financial Instruments Fair Value Measurements
9 Months Ended
Sep. 30, 2024
Fair Value Disclosures [Abstract]  
Financial Instruments Fair Value Measurements

Note 9 — Financial Instruments Fair Value Measurements

 

Recurring Fair Value Measurements

 

The fair value hierarchy table for the reporting date noted is as follows:

 

   Fair Value Measurement on a Recurring Basis at Reporting Date Using1 
   Level-1 Inputs   Level-2 Inputs   Level-3 Inputs   Total 
September 30, 2024                    
March 2023 Senior Convertible Note  $   $   $10,200   $10,200 
Totals  $   $   $10,200   $10,200 

 

   Level-1 Inputs   Level-2 Inputs   Level-3 Inputs   Total 
December 31, 2023                    
March 2023 Senior Convertible Note  $   $   $13,950   $13,950 
Totals  $   $   $13,950   $13,950 

 

1There were no transfers between the respective Levels during the nine months ended September 30, 2024.

 

As discussed in Note 10, Debt, the Company issued a Senior Secured Convertible Note dated March 21, 2023 with a $11.1 million face value principal (“March 2023 Senior Convertible Note”). The convertible note is accounted for under the ASC 825-10-15-4 fair value option (“FVO”) election, wherein, the financial instrument is initially measured at its issue date estimated fair value and subsequently remeasured at estimated fair value on a recurring basis at each reporting period date.

 

 

Note 9 — Financial Instruments Fair Value Measurements - continued

 

The estimated fair value of the financial instruments classified within the Level 3 category was determined using both observable inputs and unobservable inputs. Unrealized gains and losses associated with liabilities within the Level 3 category include changes in fair value attributable to both observable (e.g., changes in market interest rates) and unobservable (e.g., changes in unobservable long- dated volatilities) inputs.

 

The estimated fair value of the March 2023 Senior Convertible Note as of each of September 30, 2024 and December 31, 2023 were computed using a Monte Carlo simulation of the present value of its cash flows using a synthetic credit rating analysis and a required rate-of-return, using the following assumptions:

 

   March 2023 Senior Convertible Note:
September 30, 2024
   March 2023 Senior Convertible Note:
December 31, 2023
 
Fair Value  $10,200   $13,950 
Face value principal payable  $8,669   $11,019 
Required rate of return   9.20%   10.00%
Conversion Price  $5.00   $5.00 
Value of common stock  $0.82   $1.41 
Expected term (years)   0.47    1.22 
Volatility   60.00%   60.00%
Risk free rate   4.33%   4.56%
Dividend yield   %   %

 

The estimated fair values reported utilized the Company’s common stock price along with certain Level 3 inputs (as discussed in the table above), in the development of Monte Carlo simulation models, discounted cash flow analyses, and /or Black-Scholes valuation models. The estimated fair values are subjective and are affected by changes in inputs to the valuation models and analyses, including the Company’s common stock price, the Company’s dividend yield, the risk-free rates based on U.S. Treasury security yields, and certain other Level-3 inputs including, assumptions regarding the estimated volatility in the value of the Company’s common stock price and the volatility of similar entities within the medical device industry. Changes in these assumptions can materially affect the estimated fair values.

 

v3.24.3
Debt
9 Months Ended
Sep. 30, 2024
Debt Disclosure [Abstract]  
Debt

Note 10 — Debt

 

The fair value and face value principal outstanding of the March 2023 Senior Convertible Note as of the dates indicated are as follows:

 

   Contractual Maturity Date  Stated Interest Rate   Conversion Price per Share   Face Value Principal Outstanding   Fair Value 
March 2023 Senior Convertible Note  March 21, 2025   7.875%  $5.00   $8,669   $10,200 
Balance as of September 30, 2024               $8,669   $10,200 

 

   Contractual Maturity Date  Stated Interest Rate   Conversion Price per Share   Face Value Principal Outstanding   Fair Value 
March 2023 Senior Convertible Note  March 21, 2025   7.875%  $5.00   $11,019   $13,950 
Balance as of December 31, 2023               $11,019   $13,950 

 

 

Note 10 — Debt - continued

 

The changes in the fair value of debt during the three and nine month periods ended September 30, 2024 is as follows:

 

   March 2023 Senior Convertible Note   Other Income (expense) 
Fair Value - June 30, 2024  $11,200   $ 
Installment repayments – common stock   (1,142)    
Non-installment payments – common stock   (180)    
Change in fair value   322    (322)
Fair Value at September 30, 2024  $10,200    - 
Other Income (Expense) - Change in fair value – three months ended September 30, 2024       $(322)

 

   March 2023 Senior Convertible Note   Other Income (expense) 
Fair Value - December 31, 2023  $13,950   $ 
Installment repayments – common stock   (2,350)    
Non-installment payments – common stock   (832)    
Change in fair value   (568)   568 
Fair Value at September 30, 2024  $10,200    - 
Other Income (Expense) - Change in fair value – nine months ended September 30, 2024       $568 

 

The changes in the fair value of debt during the three and nine month periods ended September 30, 2023 is as follows:

 

   March 2023 Senior Convertible Note   Other Income (expense) 
Fair Value - June 30, 2023  $11,610   $ 
Installment repayments – common stock   (92)    
Non-installment payments – common stock   (49)    
Change in fair value   3,021    (3,021)
Fair Value at September 30, 2023  $14,490    - 
Other Income (Expense) - Change in fair value – three months ended September 30, 2023       $(3,021)

 

   March 2023 Senior Convertible Note   Other Income (expense) 
Fair Value - December 31, 2022  $   $ 
Face value principal – issue date   11,111   $ 
Fair value adjustment – issue date   789    (789)
Installment repayments – common stock   (92)    
Non-installment payments – common stock   (49)    
Change in fair value   2,731    (2,731)
Fair Value at September 30, 2023  $14,490    - 
Other Income (Expense) - Change in fair value – nine months ended September 30, 2023       $(3,520)

 

 

Note 10 — Debt - continued

 

March 2023 Senior Secured Convertible Note

 

Lucid Diagnostics entered into a Securities Purchase Agreement (“SPA”) dated March 13, 2023, with an accredited institutional investor (“Investor”, “Lender”, and /or “Holder”), wherein Lucid agreed to sell, and the Investor agreed to purchase, an aggregate of $11.1 million face value principal of debt.

 

Under the SPA, Lucid issued in a registered direct offering under its effective shelf registration statement a Senior Secured Convertible Note dated March 21, 2023, referred to herein as the “March 2023 Senior Convertible Note”, with such note having a $11.1 million face value principal, a 7.875% annual stated interest rate, a contractual conversion price of $5.00 per share of the Company’s common stock (subject to standard adjustments in the event of any stock split, stock dividend, stock combination, recapitalization or other similar transaction), and a contractual maturity date of March 21, 2025. The March 2023 Senior Convertible Note may be converted into shares of common stock of the Company at the Holder’s election.

 

The March 2023 Senior Convertible Note proceeds were $9.925 million after deducting a $1.186 million lender fee and offering costs. The lender fee and offering costs were recognized as of the March 21, 2023 issue date as a current period expense in other income (expense) in the Company’s unaudited condensed consolidated statement of operations.

 

During the period from March 21, 2023 to September 20, 2023, the Company was required to pay interest expense only (on the $11.1 million face value principal), at 7.875% per annum, computed on a 360 day year. The Company paid cash interest expense of $149 and $391 for the three and nine months ended September 30, 2023, respectively.

 

Commencing September 21, 2023, and then on each of the successive first and tenth trading day of each month thereafter through to and including March 14, 2025 (each referred to as an “Installment Date”); and on the March 21, 2025 maturity date, the Company will be required to make a principal repayment of $292 together with accrued interest thereon, with such 38 payments referred to herein as the “Installment Amount”, settled in shares of common stock of the Company, subject to customary equity conditions, including minimum share price and volume thresholds, or at the election of the Company, in cash, in whole or in part.

 

In addition to the Installment Amount repayments, the Holder may elect to accelerate the conversion of future Installment Amount repayments, and interest thereon, subject to certain restrictions, as defined, utilizing the then current conversion price of the most recent Installment Date conversion price.

 

The payment of all amounts due and payable under this senior convertible note is guaranteed by all of Lucid Diagnostics’ subsidiaries; and the obligations under this senior convertible note are secured by all of the assets of Lucid Diagnostics and its subsidiaries.

 

Lucid is subject to certain customary affirmative and negative covenants regarding the rank of the note, along with the incurrence of further indebtedness, the existence of liens, the repayment of indebtedness and the making of investments, the payment of cash in respect of dividends, distributions or redemptions, the transfer of assets, the maturity of other indebtedness, and transactions with affiliates, among other customary matters.

 

Lucid is subject to financial covenants requiring: (i) a minimum of $5.0 million of available cash at all times; (ii) the ratio of (a) the outstanding principal amount of the total senior convertible notes outstanding, accrued and unpaid interest thereon and accrued and unpaid late charges to (b) the Company’s average market capitalization over the prior ten trading days, as of the last day of any fiscal quarter commencing with September 30, 2023, to not exceed 30%; and (iii) the Company’s market capitalization to at no time be less than $30 million. As of September 30, 2024, the Company was in compliance, and as of the date hereof, the Company is in compliance, with the Financial Tests.

 

The March 2023 Senior Convertible Note installment payments may be made in shares of Lucid Diagnostics common stock at a conversion price that is the lower of the contractual conversion price and 82.5% of the two lowest VWAPs during the last 10 trading days preceding the date of conversion, subject to a conversion price floor of $0.30. The notes are also subject to certain provisions that may require redemption upon the occurrence of an event of default, a change of control, or certain equity issuances.

 

In the three and nine month periods ended September 30, 2024, approximately $1,142 and $2,350, respectively, of principal repayments along with approximately $180 and $832, respectively, of interest expense thereon, were settled through the issuance of 2,116,717 and 4,777,898 shares, respectively, of common stock of the Company, with such shares having a fair value of approximately $1,755 and $4,293, respectively, (with such fair value measured as the respective conversion date quoted closing price of the common stock of the Company). The conversions resulted in debt extinguishment losses of $435 and $1,116 in the three and nine month periods ended September 30, 2024, respectively. Subsequent to September 30, 2024, as of November 8, 2024, approximately $2,415 of principal repayments along with approximately $63 of interest expense thereon, were settled through the issuance of 3,847,321 shares of common stock of the Company, with such shares having a fair value of approximately $3,680 (with such fair value measured as the respective conversion date quoted closing price of the common stock of the Company).

 

 

Note 10 — Debt - continued

 

March 2023 Senior Convertible Note Refinancing

 

On November 8, 2024, the Company gave notice to the holder of the March 2023 Senior Convertible Note that it was exercising its right pursuant to such note to redeem the same for the redemption price specified in such note (the “Optional Redemption Price”). Pursuant to the terms of the March 2023 Senior Convertible Note, the Company has not less than ten business days, and not more than twenty business days, from the date of the notice (the “Optional Redemption Notice Period”) to pay the Optional Redemption Price.

 

To finance the payment of the Optional Redemption Price, the Company has entered into a securities purchase agreement with certain accredited investors (the “2024 Note Investors”). Under the agreement, subject to customary closing conditions, the Company has agreed to issue, and each 2024 Note Investor has agreed to purchase, 12.0% senior secured convertible notes due 2029 (collectively, the “November 2024 Senior Convertible Notes”). As of the date hereof, the aggregate commitments of the 2024 Note Investors exceed the Lucid Optional Redemption Price. Subsequent to September 30, 2024, as of the date hereof, the Company has received cash proceeds of $7.7 million to date related to subscription agreements for the November 2024 Senior Convertible Notes.

 

The Company expects to complete the issuance of the November 2024 Senior Convertible Notes and the redemption of the March 2023 Senior Convertible Note on or prior to the end of the Optional Redemption Notice Period.

 

 

v3.24.3
Stock-Based Compensation
9 Months Ended
Sep. 30, 2024
Share-Based Payment Arrangement [Abstract]  
Stock-Based Compensation

Note 11 — Stock-Based Compensation

 

Lucid Diagnostics 2018 Long-Term Incentive Equity Plan

 

The Lucid Diagnostics Inc. 2018 Long-Term Incentive Equity Plan (“Lucid Diagnostics 2018 Equity Plan”) is separate and apart from the PAVmed 2014 Equity Plan discussed below. The Lucid Diagnostics 2018 Equity Plan is designed to enable Lucid Diagnostics to offer employees, officers, directors, and consultants, an opportunity to acquire shares of common stock of Lucid Diagnostics. The types of awards that may be granted under the Lucid Diagnostics 2018 Equity Plan include stock options, stock appreciation rights, restricted stock, and other stock-based awards subject to limitations under applicable law. All awards are subject to approval by the Lucid Diagnostics compensation committee.

 

A total of 14,324,038 shares of common stock of Lucid Diagnostics are reserved for issuance under the Lucid Diagnostics 2018 Equity Plan, with 850,672 shares available for grant as of September 30, 2024. The share reservation is not diminished by a total of 523,300 stock options and 50,000 restricted stock awards granted outside the Lucid Diagnostics 2018 Equity Plan, as of September 30, 2024. In January 2024, the number of shares available for grant was increased by 2,680,038 in accordance with the evergreen provisions of the plan.

 

Lucid Diagnostics Stock Options

 

Lucid Diagnostics stock options granted under the Lucid Diagnostics 2018 Equity Plan and stock options granted outside such plan are summarized as follows:

 

   Number of Stock Options   Weighted Average Exercise Price   Remaining Contractual Term (Years)   Intrinsic Value(2) 
Outstanding stock options at December 31, 2023   5,504,383   $2.00    8.5   $765 
Granted(1)   3,604,000   $1.22           
Exercised   (3,333)  $1.31           
Forfeited   (442,501)  $1.63           
Outstanding stock options at September 30, 2024(3)   8,662,549   $1.69    8.3   $197 
Vested and exercisable stock options at September 30, 2024   3,654,937   $2.19    7.2   $197 

 

(1)Stock options granted under the Lucid Diagnostics 2018 Equity Plan and those granted outside such plan generally vest one-third in one year then ratably over the next eight quarters, and have a ten-year contractual term from date-of-grant.
(2)The intrinsic value is computed as the difference between the quoted price of the Lucid Diagnostics common stock on each of September 30, 2024 and December 31, 2023 and the exercise price of the underlying Lucid Diagnostics stock options, to the extent such quoted price is greater than the exercise price.
(3)The outstanding stock options presented in the table above are inclusive of 523,300 stock options granted outside the Lucid Diagnostics 2018 Equity Plan, as of September 30, 2024 and December 31, 2023.

 

On February 22, 2024, the company granted 2,895,000 stock options to employees and directors under the Lucid Diagnostics Inc 2018 Equity Plan with a weighted average exercise price of $1.25. Each option will vest one-third after one year then ratably over the next eight quarters.

 

 

Note 11 — Stock-Based Compensation - continued

 

Lucid Diagnostics Restricted Stock Awards

 

Lucid Diagnostics restricted stock awards granted under the Lucid Diagnostics 2018 Equity Plan and restricted stock awards granted outside such plan are summarized as follows:

 

   Number of Restricted Stock Awards   Weighted Average Grant Date Fair Value 
Unvested restricted stock awards as of December 31, 2023   2,337,440   $8.99 
Granted   1,600,000    1.03 
Vested   (26,912)   4.56 
Forfeited   (13,088)   4.56 
Unvested restricted stock awards as of September 30, 2024   3,897,440   $5.77 

 

In May 2024, a total of 1,600,000 restricted stock awards were granted to management under the Lucid Diagnostics 2018 Equity Plan, with such restricted stock awards having an aggregate fair value of approximately $1.5 million, which was measured using the grant date quoted closing price per share of Lucid Diagnostics Inc. common stock, with the fair value recognized as stock-based compensation expense ratably on a straight-line basis over the vesting period, which is commensurate with the service period. The vesting of the restricted stock awards vest on a single vest date of May 20, 2026. The restricted stock awards are subject to forfeiture if the requisite service period is not completed.

 

PAVmed Inc. 2014 Equity Plan

 

The PAVmed 2014 Long-Term Incentive Equity Plan (the “PAVmed 2014 Equity Plan”), is separate and apart from the Lucid Diagnostics 2018 Equity Plan (as such equity plan is discussed above).

 

Stock-Based Compensation Expense

 

The stock-based compensation expense recognized by the Company for both the Lucid Diagnostics 2018 Equity Plan and the PAVmed 2014 Equity Plan, for the periods indicated, was as follows:

 

   2024   2023   2024   2023 
  

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

 
   2024   2023   2024   2023 
Lucid Diagnostics 2018 Equity Plan – cost of revenue  $30   $16   $88   $44 
Lucid Diagnostics 2018 Equity Plan – sales and marketing   328    228    925    697 
Lucid Diagnostics 2018 Equity Plan - general and administrative   699    721    1,635    4,069 
Lucid Diagnostics 2018 Equity Plan - research and development   128    67    386    204 
PAVmed 2014 Equity Plan - cost of revenue   11    10    33    26 
PAVmed 2014 Equity Plan - sales and marketing   23    106    141    359 
PAVmed 2014 Equity Plan - general and administrative   1    7    5    170 
PAVmed 2014 Equity Plan - research and development   8    97    150    290 
Total stock-based compensation expense  $1,228   $1,252   $3,363   $5,859 

 

The stock-based compensation expense, as presented above, is inclusive of: stock options and restricted stock awards granted under the Lucid Diagnostics 2018 Equity Plan to employees of PAVmed, the physician inventors of the technology licensed under the Amended CWRU License Agreement, and members of the board of directors of Lucid Diagnostics, as well as the stock options granted under the PAVmed 2014 Equity Plan to the physician inventors.

 

 

Note 11 — Stock-Based Compensation - continued

 

As of September 30, 2024, unrecognized stock-based compensation expense and weighted average remaining requisite service period with respect to stock options and restricted stock awards issued under each of the Lucid Diagnostics 2018 Equity Plan and the PAVmed 2014 Equity Plan, as discussed above, is as follows:

 

   Unrecognized Expense   Weighted Average Remaining Service Period (Years) 
Lucid Diagnostics 2018 Equity Plan          
Stock Options  $3,798    2.0 
Restricted Stock Awards  $1,935    1.6 
PAVmed 2014 Equity Plan          
Stock Options  $109    1.7 

 

Stock-based compensation expense recognized with respect to stock options granted under the Lucid Diagnostics 2018 Equity Plan was based on a weighted average estimated fair value of such stock options of $0.79 per share and $0.88 per share during the nine month periods ended September 30, 2024 and 2023, respectively, calculated using the following weighted average Black-Scholes valuation model assumptions:

 

   2024   2023 
   Nine Months Ended September 30, 
   2024   2023 
Expected term of stock options (in years)   5.7    5.6 
Expected stock price volatility   73%   75%
Risk free interest rate   4.3%   3.7%
Expected dividend yield   %   %

 

Lucid Diagnostics Inc Employee Stock Purchase Plan (“Lucid ESPP”)

 

A total of 511,884 shares and 231,987 shares of common stock of Lucid Diagnostics were purchased for proceeds of approximately $353 and $276 on March 31, 2024 and 2023, respectively, under the Lucid ESPP. A total of 136,056 and 276,213 shares of common stock of Lucid Diagnostics were purchased for proceeds of approximately $94 and $275 on September 30, 2024 and 2023, respectively, under the Lucid ESPP. The Lucid ESPP has a total reservation of 1,500,000 shares of common stock of which 259,830 shares are available for issue as of September 30, 2024. In January 2024, our board authorized an increase in the number of shares available for issue by 500,000.

 

v3.24.3
Stockholders’ Equity
9 Months Ended
Sep. 30, 2024
Equity [Abstract]  
Stockholders’ Equity

Note 12 — Stockholders’ Equity

 

Series B Preferred Stock Offering and Exchange

 

On March 13, 2024, the Company entered into subscription agreements (each, a “Series B Subscription Agreement”) and exchange agreements (each, a “Series B Exchange Agreement”) with certain accredited investors (collectively, the “Series B Investors”), which agreements provided for (i) the sale to the Series B Investors of 12,495 shares of newly designated Series B Convertible Preferred Stock, par value $0.001 per share (the “Series B Preferred Stock”), at a purchase price of $1,000 per share, and (ii) the exchange by the Series B Investors of 13,625 shares of Lucid Series A Convertible Preferred Stock, par value $0.001 per share (the “Series A Preferred Stock”), and 10,670 shares of Lucid Series A-1 Convertible Preferred Stock, par value $0.001 per share (the “Series A-1 Preferred Stock”), held by them for 31,790 shares of Series B Preferred Stock (collectively, the “Series B Offering and Exchange”). Prior to the execution of the Series B Subscription Agreements and the Series B Exchange Agreements, the Company entered into subscription agreements with certain of the Series B Investors providing for the sale to such investors of 5,670 shares of Series A-1 Preferred Stock, at a purchase price of $1,000 per share, which shares the investors immediately agreed to exchange for shares of Series B Preferred Stock pursuant to the Series B Exchange Agreements (and are included in the 10,670 shares of Series A-1 Preferred Stock set forth above). Each share of the Series B Preferred Stock has a stated value of $1,000 and a conversion price of $1.2444. The terms of the Series B Preferred Stock also include a one times preference on liquidation and a right to receive dividends equal to 20% of the number of shares of our common stock into which such Series B Preferred Stock is convertible, payable on the one-year and two-year anniversary of the issuance date. The holders of the Series B Preferred Stock also will be entitled to dividends equal, on an as-if-converted to shares of common stock basis, to and in the same form as dividends actually paid on shares of the common stock when, as, and if such dividends are paid on shares of the common stock. The Series B Preferred Stock is a voting security. The aggregate gross proceeds of these transactions were $18.1 million (inclusive of $5.7 million of aggregate gross proceeds from the sale of the Series A-1 Preferred Stock that was immediately exchanged for Series B Preferred Stock in the transactions).

 

 

Note 12 — Stockholders' Equity - continued

 

As a result of 100% of the then-outstanding shares of Series A Preferred Stock and Series A-1 Preferred Stock being exchanged for shares of Series B Preferred Stock in the Series B Offering and Exchange, no shares of Series A Preferred Stock or Series A-1 Preferred Stock remain outstanding.

 

In connection with the issuance, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of the Series B Preferred Stock with the Secretary of State of the State of Delaware (the “Certificate of Designation”). The key terms of the Series B Preferred Stock are as follows:

 

Each share of Series B Preferred Stock is convertible at the option of the holder, subject to certain beneficial ownership limitations into such number of shares of the Company’s common stock, equal to the number of Series B Preferred Shares to be converted, multiplied by the stated value of $1,000 (the “Stated Value”), divided by the conversion price in effect at the time of the conversion. The initial conversion price is $1.2444, subject to adjustment in the event of stock splits, stock dividends, and similar transactions. The Series B Preferred Stock is convertible into shares of our common stock at any time at the option of the holder from and after the six-month anniversary of its issuance, and automatically converts into shares of our common stock on March 13, 2026, the second anniversary of its issuance at a conversion price of $1.2444, and the Series B Preferred Stock is a voting security (subject to applicable ownership limitations). In addition, the Series B Preferred Stock issued in exchange for Series A Preferred Stock and Series A-1 Preferred Stock may be converted, at the election of the Company at any time after the six-month anniversary of the issuance of such shares of Series B Preferred Stock, upon written notice given to the holders of such shares, if the volume weight average price of our common stock has been at least $8.00 per share (subject to adjustment in the event of stock splits, stock dividends, and similar transactions) on 20 out of 30 consecutive trading days ending within 15 trading days prior to the date on which such notice is given (subject to certain limited exceptions) (a “VWAP-Based Mandatory Conversion”).

 

The Series B Preferred Stock will be senior to the Common Stock and any other class of the Company’s capital stock that is not by its terms senior to or pari passu with the Series B Preferred Stock.

 

The holders of Series B Preferred Stock will be entitled to dividends payable as follows: (i) a number of shares of Common Stock equal to 20% of the number of shares of Common Stock issuable upon conversion of the Series B Preferred Stock then held by such Holder on March 13, 2025, and (ii) a number of shares of Common Stock equal to 20% of the number of shares of Common Stock issuable upon conversion of the Series B Preferred Stock then held by such Holder on March 13, 2026. A holder that voluntarily converts its Series B Preferred Stock prior to March 13, 2025 or March 13, 2026, as the case may be, will not receive the dividend that accrues on such date with respect to such converted Series B Preferred Stock. The holders of the Series B Preferred Stock also will be entitled to dividends equal, on an as-if-converted to shares of Common Stock basis, to and in the same form as dividends actually paid on shares of the Common Stock when, as, and if such dividends are paid on shares of the Common Stock.

 

In the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company (or any Deemed Liquidation Event as defined in the Certificate of Designation), the holders of shares of Series B Preferred Stock then outstanding will be entitled to be paid out of the assets of the Company available for distribution to its stockholders, before any payment shall be made to the holders of Common Stock by reason of their ownership thereof, an amount per share equal to the greater of (i) the Stated Value, plus any dividends accrued but unpaid thereon, or (ii) such amount per share as would have been payable had all shares of Series B Preferred Stock been converted into Common Stock immediately prior to such event.

 

The Series B Preferred Stock is a voting security (subject to applicable ownership limitations).

 

The Company will not effect any conversion of the Series B Preferred Stock, and a holder will not have the right to receive dividends or convert any portion of the Series B Preferred Stock, to the extent that, after giving effect to the receipt of dividends or the conversion, the holder (together with such holder’s affiliates, and any persons acting as a group together with such holder or any of the holder’s affiliates) would beneficially own in excess of 4.99% of the Company’s outstanding common stock (or, upon election of the holder, 9.99% of the Company’s outstanding common stock).

 

The Company and the investors in the offering also executed a registration rights agreement (the “Series B Registration Rights Agreement”), pursuant to which the Company agreed to file a registration statement covering the resale of the shares of Common Stock issuable pursuant to the Series B Preferred Stock. The Company filed such registration statement on Form S-3 with the SEC (file number 333-280650), which filing became effective on July 18, 2024, covering the resale of the shares of Common Stock issuable pursuant to the Series B and Series B-1 Preferred Stock.

 

Series B-1 Preferred Stock Offering

 

On May 6, 2024, the Company issued approximately 11,634 shares of newly designated Series B-1 Convertible Preferred Stock (the “Series B-1 Preferred Stock”). The terms of the Series B-1 Preferred Stock are substantially identical to the terms of the Series B Preferred Stock, except that the Series B-1 Preferred Stock has a conversion price of $0.7228 and is not subject to a VWAP-Based Mandatory Conversion. The aggregate gross proceeds from the sale of shares in such offering were $11.6 million.

 

 

Note 12 — Stockholders' Equity - continued

 

Series A Preferred Stock Offering

 

On March 7, 2023, the Company issued 13,625 shares of newly designated Series A Convertible Preferred Stock, par value $0.001 per share (the “Series A Preferred Stock”). The terms of the Series A Preferred Stock were substantially identical to the terms of the Series B-1 Preferred Stock, except that the Series A Preferred Stock had a conversion price of $1.394 and was not a voting security. The aggregate gross proceeds from the sale of shares in such offering were $13.6 million.

 

As noted above, on March 13, 2024, 100% of the then-outstanding shares of Series A Preferred Stock were exchanged for shares of Series B Preferred Stock in the Series B Preferred Stock Offering and Exchange. As a result, no shares of Series A Preferred Stock remain outstanding.

 

Series A-1 Preferred Stock Offering

 

On October 17, 2023, the Company issued 5,000 shares of newly designated Series A-1 Convertible Preferred Stock (the “Series A-1 Preferred Stock”). The terms of the Series A-1 Preferred Stock were substantially identical to the terms of the Series A Preferred Stock, except that the Series A-1 Preferred Stock has a conversion price of $1.2592. The aggregate gross proceeds from the sale of shares in such offering were $5.0 million.

 

On March 13, 2024, the Company issued an additional 5,670 shares of Series A-1 Preferred Stock.

 

As noted above, on March 13, 2024, 100% of the then-outstanding shares of Series A-1 Preferred Stock were exchanged for shares of Series B Preferred Stock in the Series B Preferred Stock Offering and Exchange. As a result, no shares of Series A-1 Preferred Stock remain outstanding.

 

Deemed Dividend on Series A and Series A-1 Convertible Preferred Stock Exchange Offer

 

The fair value of the consideration given in the form of the issue of 31,790 shares of Series B Convertible Preferred Stock, with such fair value recognized as the carrying value of such issued shares of Series B Convertible Preferred Stock, as compared to the carrying value of the extinguished Series A and Series A-1 Convertible Preferred Stock (carrying value of $24,294), resulting in an excess of fair value of $7.5 million recognized as a deemed dividend charged to accumulated deficit in the unaudited condensed consolidated balance sheet on March 13, 2024, with such deemed dividend included as a component of net loss attributable to common stockholders, summarized as follows:

 

Series B Convertible Preferred Stock Issuance and Series A/A-1 Exchange Offer  March 13, 2024 
     
Fair Value - 31,790 shares of Series B Preferred Stock issued in exchange for Series A and Series A-1 Preferred Stock  $31,790 
Less: Carrying value related to Series A and Series A-1 Preferred Stock Exchanged for Series B Preferred Stock (of 24,295 shares)   (24,294)
Deemed Dividend Charged to Accumulated Deficit  $7,496 

 

Lucid Diagnostics Common Stock

 

In July 2024, the Company received shareholder approval to amend its certificate of incorporation, as amended, to increase the total number of shares of common stock the Company is authorized to issue by 100 million shares from 200 million shares to 300 million shares. An amendment effecting such change was filed with the Secretary of State of Delaware on July 23, 2024.

 

Additionally in July 2024, the Company’s shareholders approved, for purposes of Listing Rule 5635 of The Nasdaq Stock Market LLC (“Nasdaq”) the issuance of shares of the Company’s common stock under the Series B Convertible Preferred Stock (“Series B Preferred Stock”) sold by the Company in a private offering in March 2024 and the Series B-1 Convertible Preferred Stock (“Series B-1 Preferred Stock”) sold by the Company in a private offering in May 2024. Each of the Series B and Series B-1 Preferred Stock is a voting security. On any matter to be acted upon or considered by the stockholders of the Company, each holder shall be entitled to vote on an “as converted” basis after applying the beneficial ownership limitations described in the Series B and B-1 Preferred Stock Offering above.

 

As of September 30, 2024 and December 31, 2023, there were 51,597,718 and 42,329,864 shares of common stock issued and outstanding, respectively. On September 10, 2024, following preferred equity transactions completed by the Company earlier in 2024 and the termination of voting proxies entered into between PAVmed and certain shareholders of the Company, PAVmed’s voting interest in the Company was reduced to less than 50.0%, resulting in the loss of a controlling financial interest. However, PAVmed retains the ability to exercise significant influence over Lucid. As of September 30, 2024, PAVmed holds 31,302,444 shares.

 

On January 26, 2024, PAVmed elected to receive payment of $4,675 of fees and reimbursements due from Lucid, through the issuance of 3,331,771 shares of Lucid Diagnostics common stock. Substantially all of such shares were distributed by PAVmed to its shareholders on February 15, 2024.

 

 

Note 12 — Stockholders' Equity - continued

 

On June 21, 2024, the Company received a notice from the Listing Qualifications Department of Nasdaq stating that, for the prior 30 consecutive business days (through June 20, 2024), the closing bid price of the Company’s common stock had been below the minimum of $1 per share required for continued listing on the Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). The notification letter stated that the Company would be afforded 180 calendar days (until December 18, 2024) to regain compliance, and that the Company could be eligible for additional time. The Company intends to consider all available options to regain compliance with the Nasdaq listing standards.

 

In the nine months ended September 30, 2024, the Company issued 480,000 shares of common stock to vendors in exchange for $401 of agreed upon services, which is included in general and administrative operating expenses on the Company’s unaudited condensed consolidated statement of operations.

 

Committed Equity Facility and ATM Facility

 

On March 28, 2022, the Company entered into a committed equity facility with an affiliate of Cantor Fitzgerald (“Cantor”). Under the terms of the committed equity facility, Cantor has committed to purchase up to $50 million of the Company’s common stock from time to time at the request of the Company. While there are distinct differences, the facility is structured similarly to a traditional at-the-market equity facility, insofar as it allows the Company to raise primary equity capital on a periodic basis at prices based on the existing market price. Cumulatively a total of 680,263 shares of Lucid Diagnostics’ common stock were issued for net proceeds of approximately $1.8 million, after a 4% discount, as of September 30, 2024.

 

In November 2022, the Company entered into an “at-the-market offering” (“ATM”) for up to $6.5 million of its common stock that may be offered and sold under a Controlled Equity Offering Agreement between the Company and Cantor. Cumulatively a total of 230,068 shares of Lucid Diagnostics’ common stock were issued through the at-the-market equity facility for net proceeds of approximately $0.3 million, after payments of 3% commissions, as of September 30, 2024.

 

 

v3.24.3
Net Loss Per Share
9 Months Ended
Sep. 30, 2024
Earnings Per Share [Abstract]  
Net Loss Per Share

Note 13 — Net Loss Per Share

 

The Net loss per share basic and diluted for the respective periods indicated is as follows:

 

   2024   2023   2024   2023 
  

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

 
   2024   2023   2024   2023 
Numerator                
Net loss  $(12,371)  $(14,208)  $(33,988)  $(41,836)
Deemed dividend on Series A and Series A-1 Convertible Preferred Stock           (7,496)    
Net loss attributable to Lucid Diagnostics Inc. common stockholders  $(12,371)  $(14,208)  $(41,484)  $(41,836)
                     
Denominator                    
Weighted average common shares outstanding, basic and diluted   50,374,146    41,862,805    47,876,015    41,558,979 
                     
Net loss per share (1)                    
Net loss per share - basic and diluted  $(0.25)  $(0.34)  $(0.87)  $(1.01)

 

(1) - Convertible Preferred Stock would potentially be considered a participating security under the two-class method of calculating net loss per share. However, the Company has incurred net losses to-date, and as such holders are not contractually obligated to share in the losses, there is no impact on the Company’s net loss per share calculation for the periods indicated.

 

Basic weighted-average number of shares of common stock outstanding for the nine month periods ended September 30, 2024 and 2023 include the shares of the Company issued and outstanding during such periods, each on a weighted average basis. The basic weighted average number of shares common stock outstanding excludes common stock equivalent incremental shares, while diluted weighted average number of shares outstanding includes such incremental shares. However, as the Company was in a loss position for all years presented, basic and diluted weighted average shares outstanding are the same, as the inclusion of the incremental shares would be anti-dilutive. The common stock equivalents excluded from the computation of diluted weighted average shares outstanding are as follows:

 

   2024   2023 
   September 30, 
   2024   2023 
         
Stock options   8,662,549    4,957,215 
Unvested restricted stock awards   3,897,440    1,787,440 
Preferred stock   51,682,378    13,683,647 
Total   64,242,367    20,428,302 

 

v3.24.3
Summary of Significant Accounting Policies (Policies)
9 Months Ended
Sep. 30, 2024
Accounting Policies [Abstract]  
Basis of Presentation

Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements of the Company and its subsidiaries have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”), and applicable rules and regulations of the United States Securities and Exchange Commission (“SEC”), and include the accounts of the Company and its wholly-owned subsidiaries. All intercompany transactions and balances have been eliminated in consolidation. The Company is a non-consolidated subsidiary of PAVmed, which has the ability to exercise significant influence over the Company. The Company manages its operations as a single operating segment for the purposes of assessing performance and making operating decisions.

 

As permitted under SEC rules, certain footnotes or other financial information normally required by U.S. GAAP have been condensed or omitted. The balance sheet as of December 31, 2023 has been derived from audited consolidated financial statements at such date. The accompanying unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements, and in the opinion of management, include all adjustments, consisting only of routine recurring adjustments, necessary for a fair statement of the Company’s unaudited condensed consolidated financial information.

 

The unaudited condensed consolidated results of operations for the three and nine months ended September 30, 2024 are not necessarily indicative of the consolidated results to be expected for the year ending December 31, 2024 or for any other interim period or for any other future periods. The accompanying unaudited condensed consolidated financial statements and related unaudited condensed consolidated financial information should be read in conjunction with the Company’s audited consolidated financial statements and related notes thereto as of and for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K as filed with the SEC on March 25, 2024.

 

All amounts in the accompanying unaudited condensed consolidated financial statements and the notes thereto are presented in thousands of dollars, if not otherwise noted as being presented in millions of dollars, except for shares and per share amounts.

 

Use of Estimates

Use of Estimates

 

In preparing the unaudited condensed consolidated financial statements in conformity with U.S. GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and the determination of corresponding carrying value reserves, if any, and liabilities and the disclosure of contingent losses, as of the date of the unaudited condensed consolidated financial statements, as well as the reported amounts of revenue and expenses during the reporting period. Significant estimates in these unaudited condensed consolidated financial statements include those related to the estimated fair value of debt obligations, stock-based equity awards and intangible assets. Other significant estimates include the estimated incremental borrowing rate, the provision or benefit for income taxes and the corresponding valuation allowance on deferred tax assets. Additionally, management’s assessment of the Company’s ability to continue as a going concern involves the estimation of the amount and timing of future cash inflows and outflows. On an ongoing basis, the Company evaluates its estimates and assumptions. The Company bases its estimates on historical experience and on various other assumptions believed to be reasonable. Due to inherent uncertainty involved in making estimates, actual results reported in future periods may be affected by changes in these estimates.

 

Revenue Recognition

Revenue Recognition

 

Revenues are recognized when the satisfaction of the performance obligation occurs, in an amount that reflects the consideration the Company expects to collect in exchange for those services. The Company’s revenue is primarily generated by its laboratory testing services utilizing its EsoGuard Esophageal DNA tests. The services are completed upon release of a patient’s test result to the ordering healthcare provider. Revenue recognized is inclusive of both variable consideration in connection with an individual patient’s third-party insurance coverage policy and fixed consideration in connection with a contracted services arrangement with an unrelated third party legal entity. To determine revenue recognition for the arrangements that the Company determines are within the scope of ASC 606, Revenue from Contracts with Customers, the Company performs the following five steps: (1) identify the contract(s) with a customer, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract and (5) recognize revenue when (or as) the entity satisfies a performance obligation.

 

 

Note 3 — Summary of Significant Accounting Policies - continued

 

The key aspects considered by the Company include the following:

 

Contracts—The Company’s customer is primarily the patient, but the Company does not enter into a formal reimbursement contract with a patient. The Company establishes a contract with a patient in accordance with other customary business practices, which is the point in time an order is received from a provider and a patient specimen has been returned to the laboratory for testing. Payment terms are a function of a patient’s existing insurance benefits, including the impact of coverage decisions with Center for Medicare & Medicaid Services (“CMS”) and applicable reimbursement contracts established between the Company and payers. However, when a patient is considered self-pay, the Company requires payment from the patient prior to the commencement of the Company’s performance obligations. The Company’s consideration can be deemed variable or fixed depending on the structure of specific payer contracts, and the Company considers collection of such consideration to be probable to the extent that it is unconstrained.

 

Performance obligations—A performance obligation is a promise in a contract to transfer a distinct good or service (or a bundle of goods or services) to the customer. The Company’s contracts have a single performance obligation, which is satisfied upon rendering of services, which culminates in the release of a patient’s test result to the ordering healthcare provider. The Company elects the practical expedient related to the disclosure of unsatisfied performance obligations, as the duration of time between providing testing supplies, the receipt of a sample, and the release of a test result to the ordering healthcare provider is far less than one year.

 

Transaction price—The transaction price is the amount of consideration that the Company expects to collect in exchange for transferring promised goods or services to a customer, excluding amounts collected on behalf of third parties (for example, some sales taxes). The consideration expected to be collected from a contract with a customer may include fixed amounts, variable amounts, or both.

 

If the consideration derived from the contracts is deemed to be variable, the Company estimates the amount of consideration to which it will be entitled in exchange for the promised goods or services. The Company limits the amount of variable consideration included in the transaction price to the unconstrained portion of such consideration. In other words, the Company recognizes revenue up to the amount of variable consideration that is not subject to a significant reversal until additional information is obtained or the uncertainty associated with the additional payments or refunds is subsequently resolved.

 

When the Company does not have significant historical experience or that experience has limited predictive value, the constraint over estimates of variable consideration may result in no revenue being recognized upon delivery of patient EsoGuard test results to the ordering healthcare provider. As such, the Company recognizes revenue up to the amount of variable consideration not subject to a significant reversal until additional information is obtained or the uncertainty associated with additional payments or refunds, if any, is subsequently resolved. Differences between original estimates and subsequent revisions, including final settlements, represent changes in estimated expected variable consideration, with the change in estimate recognized in the period of such revised estimate. With respect to a contracted service arrangement, the fixed consideration revenue is recognized on an as-billed basis upon delivery of the laboratory test report with realization of such fixed consideration deemed probable based upon actual historical experience.

 

Allocate transaction price—The transaction price is allocated entirely to the performance obligation contained within the contract with a customer on the basis of the relative standalone selling prices of each distinct good or service.

 

Practical Expedients—The Company does not adjust the transaction price for the effects of a significant financing component, as at contract inception, the Company expects the collection cycle to be one year or less.

 

Fair Value Option (“FVO”) Election

Fair Value Option (“FVO”) Election

 

Under a Securities Purchase Agreement dated March 13, 2023, the Company issued a Senior Secured Convertible Note dated March 21, 2023, referred to herein as the “March 2023 Senior Convertible Note”, which is accounted under the “fair value option election” as discussed below.

 

Under Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 815, Derivative and Hedging, (“ASC 815”), a financial instrument containing embedded features and/or options may be required to be bifurcated from the financial instrument host and recognized as separate derivative asset or liability, with the bifurcated derivative asset or liability initially measured at estimated fair value as of the transaction issue date and then subsequently remeasured at estimated fair value as of each reporting period balance sheet date.

 

Alternatively, FASB ASC Topic 825, Financial Instruments, (“ASC 825”) provides for the “fair value option” (“FVO”) election. In this regard, ASC 825-10-15-4 provides for the FVO election (to the extent not otherwise prohibited by ASC 825-10-15-5) to be afforded to financial instruments, wherein the financial instrument is initially measured at estimated fair value as of the transaction issue date and then subsequently remeasured at estimated fair value as of each reporting period balance sheet date, with changes in the estimated fair value recognized as other income (expense) in the statement of operations. The estimated fair value adjustment of the March 2023 Senior Convertible Note, including the component related to accrued interest, is presented in a single line item within other income (expense) in the accompanying unaudited condensed consolidated statement of operations (as provided for by ASC 825-10-50-30(b)). Further, as required by ASC 825-10-45-5, to the extent a portion of the fair value adjustment is attributed to a change in the instrument-specific credit risk, such portion would be recognized as a component of other comprehensive income (“OCI”) (for which there was no such adjustment with respect to the March 2023 Senior Convertible Note).

 

See Note 9, Financial Instruments Fair Value Measurements, with respect to the FVO election; and Note 10, Debt, for a discussion of the March 2023 Senior Convertible Note.

 

 

Note 3 — Summary of Significant Accounting Policies - continued

 

Recent Accounting Standards Updates Not Yet Adopted

Recent Accounting Standards Updates Not Yet Adopted

 

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740)—Improvements to Income Tax Disclosures (“ASU 2023-09”), which is intended to enhance the transparency and decision usefulness of income tax disclosures. The amendments in ASU 2023-09 provide for enhanced income tax information primarily through changes to the rate reconciliation and income taxes paid information. ASU 2023-09 is effective for the Company prospectively to all annual periods beginning after December 15, 2024. Early adoption is permitted. The Company does not expect the standard to have a significant impact on its unaudited condensed consolidated financial statements.

 

In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280)—Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which require public companies disclose significant segment expenses and other segment items on an annual and interim basis and to provide in interim periods all disclosures about a reportable segment’s profit or loss and assets that are currently required annually. The guidance is effective for public entities for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. The guidance is applied retrospectively to all periods presented in the financial statements, unless it is impracticable. The Company is currently evaluating the impact this update will have on its unaudited condensed consolidated financial statements and disclosures, however the company does not expect the standard to have a significant impact.

 

In October 2023, the FASB issued ASU No. 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative. This update modifies the disclosure or presentation requirements of a variety of topics in the Accounting Standards Codification to conform with certain SEC amendments in Release No. 33-10532, Disclosure Update and Simplification. The amendments in this update should be applied prospectively, and the effective date for each amendment will be the date on which the SEC’s removal of that related disclosure from Regulation S-X or S-K becomes effective. However, if the SEC has not removed the related disclosure from its regulations by June 30, 2027, the amendments will be removed from the Codification and not become effective. Early adoption is prohibited. The Company is currently evaluating the impact this update will have on its unaudited condensed consolidated financial statements and disclosures.

v3.24.3
Related Party Transactions (Tables)
9 Months Ended
Sep. 30, 2024
Related Party Transactions [Abstract]  
Schedule of Due To: PA Vmed Inc

The aggregate Due To: PAVmed Inc. for the period indicated is summarized as follows:

 

                 
   MSA Fees   Employee-Related Costs   PAVmed Inc. OBO Payments   Total 
Balance - December 31, 2023  $6,150   $3,163   $26   $9,339 
MSA fees   8,150            8,150 
ERC - Benefits       1,411        1,411 
On Behalf Of (OBO) activities           598    598 
Cash payments to PAVmed Inc.   (12,650)   (1,537)   (583)   (14,770)
Payment to PAVmed Inc. settled in LUCD stock   (1,650)   (3,025)       (4,675)
Balance - September 30, 2024  $   $12   $41   $53 
Schedule of MSA Fee Expense Classification in Statements of Operations

The MSA Fee expense classification in the unaudited condensed consolidated statement of operations for the periods noted is as follows:

 

   2024   2023   2024   2023 
  

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

 
   2024   2023   2024   2023 
Sales & Marketing   164    109   $417   $218 
General & Administrative   2,253    1,554    5,860    3,108 
Research & Development   733    587    1,873    1,174 
Total MSA Fee  $3,150   $2,250   $8,150   $4,500 
v3.24.3
Prepaid Expenses, Deposits, and Other Current Assets (Tables)
9 Months Ended
Sep. 30, 2024
Prepaid Expenses Deposits And Other Current Assets  
Schedule of Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following as of:

 

   September 30, 2024   December 31, 2023 
Advanced payments to service providers and suppliers  $389   $266 
Prepaid insurance   49    607 
Deposits   1,207    1,981 
Total prepaid expenses, deposits and other current assets  $1,645   $2,854 
v3.24.3
Leases (Tables)
9 Months Ended
Sep. 30, 2024
Leases  
Schedule of Future Lease Payments of Operating Lease Liabilities

The Company’s future lease payments as of September 30, 2024, which are presented as operating lease liabilities, current portion and operating lease liabilities, less current portion on the Company’s unaudited condensed consolidated balance sheets are as follows:

 

      
2024 (remainder of year)  $266 
2025   1,025 
2026   979 
2027   940 
2028   19 
Total lease payments  $3,229 
Less: imputed interest   (363)
Present value of lease liabilities  $2,866 
Schedule of Cash Flow Supplemental Information

Supplemental disclosure of cash flow information related to the Company’s cash and non-cash activities with its leases are as follows:

 

   2024   2023 
   Nine Months Ended September 30, 
   2024   2023 
Cash paid for amounts included in the measurement of lease liabilities          
Operating cash flows from operating leases  $889   $894 
Non-cash investing and financing activities          
Right-of-use assets obtained in exchange for new operating lease liabilities  $2,347   $380 
Weighted-average remaining lease term - operating leases (in years)   3.17    1.58 
Weighted-average discount rate - operating leases   7.875%   7.875%
v3.24.3
Intangible Assets, net (Tables)
9 Months Ended
Sep. 30, 2024
Goodwill and Intangible Assets Disclosure [Abstract]  
Schedule of Intangible Assets

Intangible assets, less accumulated amortization, consisted of the following as of:

 

   Estimated Useful Life  September 30, 2024   December 31, 2023 
Defensive technology  60 months  $2,105   $2,105 
Laboratory licenses and certifications and laboratory information management software  24 months   3,200   $3,200 
Total Intangible assets      5,305    5,305 
Less Accumulated Amortization      (4,463)   (3,881)
Intangible Assets, net     $842   $1,424 
Schedule of Future Amortization Expense

 

      
2024 (remainder of year)  $105 
2025   421 
2026   316 
Total  $842 
v3.24.3
Financial Instruments Fair Value Measurements (Tables)
9 Months Ended
Sep. 30, 2024
Fair Value Disclosures [Abstract]  
Schedule of Financial Liabilities Measured at Fair Value on Recurring Basis

The fair value hierarchy table for the reporting date noted is as follows:

 

   Fair Value Measurement on a Recurring Basis at Reporting Date Using1 
   Level-1 Inputs   Level-2 Inputs   Level-3 Inputs   Total 
September 30, 2024                    
March 2023 Senior Convertible Note  $   $   $10,200   $10,200 
Totals  $   $   $10,200   $10,200 

 

   Level-1 Inputs   Level-2 Inputs   Level-3 Inputs   Total 
December 31, 2023                    
March 2023 Senior Convertible Note  $   $   $13,950   $13,950 
Totals  $   $   $13,950   $13,950 

 

1There were no transfers between the respective Levels during the nine months ended September 30, 2024.
Schedule of Fair Value Assumption Used

The estimated fair value of the March 2023 Senior Convertible Note as of each of September 30, 2024 and December 31, 2023 were computed using a Monte Carlo simulation of the present value of its cash flows using a synthetic credit rating analysis and a required rate-of-return, using the following assumptions:

 

   March 2023 Senior Convertible Note:
September 30, 2024
   March 2023 Senior Convertible Note:
December 31, 2023
 
Fair Value  $10,200   $13,950 
Face value principal payable  $8,669   $11,019 
Required rate of return   9.20%   10.00%
Conversion Price  $5.00   $5.00 
Value of common stock  $0.82   $1.41 
Expected term (years)   0.47    1.22 
Volatility   60.00%   60.00%
Risk free rate   4.33%   4.56%
Dividend yield   %   %
v3.24.3
Debt (Tables)
9 Months Ended
Sep. 30, 2024
Debt Disclosure [Abstract]  
Summary of Outstanding Debt

The fair value and face value principal outstanding of the March 2023 Senior Convertible Note as of the dates indicated are as follows:

 

   Contractual Maturity Date  Stated Interest Rate   Conversion Price per Share   Face Value Principal Outstanding   Fair Value 
March 2023 Senior Convertible Note  March 21, 2025   7.875%  $5.00   $8,669   $10,200 
Balance as of September 30, 2024               $8,669   $10,200 

 

   Contractual Maturity Date  Stated Interest Rate   Conversion Price per Share   Face Value Principal Outstanding   Fair Value 
March 2023 Senior Convertible Note  March 21, 2025   7.875%  $5.00   $11,019   $13,950 
Balance as of December 31, 2023               $11,019   $13,950 
Schedule of Changes in Fair Value of Debt

The changes in the fair value of debt during the three and nine month periods ended September 30, 2024 is as follows:

 

   March 2023 Senior Convertible Note   Other Income (expense) 
Fair Value - June 30, 2024  $11,200   $ 
Installment repayments – common stock   (1,142)    
Non-installment payments – common stock   (180)    
Change in fair value   322    (322)
Fair Value at September 30, 2024  $10,200    - 
Other Income (Expense) - Change in fair value – three months ended September 30, 2024       $(322)

 

   March 2023 Senior Convertible Note   Other Income (expense) 
Fair Value - December 31, 2023  $13,950   $ 
Installment repayments – common stock   (2,350)    
Non-installment payments – common stock   (832)    
Change in fair value   (568)   568 
Fair Value at September 30, 2024  $10,200    - 
Other Income (Expense) - Change in fair value – nine months ended September 30, 2024       $568 

 

The changes in the fair value of debt during the three and nine month periods ended September 30, 2023 is as follows:

 

   March 2023 Senior Convertible Note   Other Income (expense) 
Fair Value - June 30, 2023  $11,610   $ 
Installment repayments – common stock   (92)    
Non-installment payments – common stock   (49)    
Change in fair value   3,021    (3,021)
Fair Value at September 30, 2023  $14,490    - 
Other Income (Expense) - Change in fair value – three months ended September 30, 2023       $(3,021)

 

   March 2023 Senior Convertible Note   Other Income (expense) 
Fair Value - December 31, 2022  $   $ 
Face value principal – issue date   11,111   $ 
Fair value adjustment – issue date   789    (789)
Installment repayments – common stock   (92)    
Non-installment payments – common stock   (49)    
Change in fair value   2,731    (2,731)
Fair Value at September 30, 2023  $14,490    - 
Other Income (Expense) - Change in fair value – nine months ended September 30, 2023       $(3,520)
v3.24.3
Stock-Based Compensation (Tables)
9 Months Ended
Sep. 30, 2024
Share-Based Payment Arrangement [Abstract]  
Schedule of Stock Options Issued and Outstanding Activities

Lucid Diagnostics stock options granted under the Lucid Diagnostics 2018 Equity Plan and stock options granted outside such plan are summarized as follows:

 

   Number of Stock Options   Weighted Average Exercise Price   Remaining Contractual Term (Years)   Intrinsic Value(2) 
Outstanding stock options at December 31, 2023   5,504,383   $2.00    8.5   $765 
Granted(1)   3,604,000   $1.22           
Exercised   (3,333)  $1.31           
Forfeited   (442,501)  $1.63           
Outstanding stock options at September 30, 2024(3)   8,662,549   $1.69    8.3   $197 
Vested and exercisable stock options at September 30, 2024   3,654,937   $2.19    7.2   $197 

 

(1)Stock options granted under the Lucid Diagnostics 2018 Equity Plan and those granted outside such plan generally vest one-third in one year then ratably over the next eight quarters, and have a ten-year contractual term from date-of-grant.
(2)The intrinsic value is computed as the difference between the quoted price of the Lucid Diagnostics common stock on each of September 30, 2024 and December 31, 2023 and the exercise price of the underlying Lucid Diagnostics stock options, to the extent such quoted price is greater than the exercise price.
(3)The outstanding stock options presented in the table above are inclusive of 523,300 stock options granted outside the Lucid Diagnostics 2018 Equity Plan, as of September 30, 2024 and December 31, 2023.
Schedule of Restricted Stock Award Activity

Lucid Diagnostics restricted stock awards granted under the Lucid Diagnostics 2018 Equity Plan and restricted stock awards granted outside such plan are summarized as follows:

 

   Number of Restricted Stock Awards   Weighted Average Grant Date Fair Value 
Unvested restricted stock awards as of December 31, 2023   2,337,440   $8.99 
Granted   1,600,000    1.03 
Vested   (26,912)   4.56 
Forfeited   (13,088)   4.56 
Unvested restricted stock awards as of September 30, 2024   3,897,440   $5.77 
Schedule of Stock-Based Compensation Expense

The stock-based compensation expense recognized by the Company for both the Lucid Diagnostics 2018 Equity Plan and the PAVmed 2014 Equity Plan, for the periods indicated, was as follows:

 

   2024   2023   2024   2023 
  

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

 
   2024   2023   2024   2023 
Lucid Diagnostics 2018 Equity Plan – cost of revenue  $30   $16   $88   $44 
Lucid Diagnostics 2018 Equity Plan – sales and marketing   328    228    925    697 
Lucid Diagnostics 2018 Equity Plan - general and administrative   699    721    1,635    4,069 
Lucid Diagnostics 2018 Equity Plan - research and development   128    67    386    204 
PAVmed 2014 Equity Plan - cost of revenue   11    10    33    26 
PAVmed 2014 Equity Plan - sales and marketing   23    106    141    359 
PAVmed 2014 Equity Plan - general and administrative   1    7    5    170 
PAVmed 2014 Equity Plan - research and development   8    97    150    290 
Total stock-based compensation expense  $1,228   $1,252   $3,363   $5,859 
Schedule of Unrecognized Compensation Expense and Weighted Average Remaining Service Period

As of September 30, 2024, unrecognized stock-based compensation expense and weighted average remaining requisite service period with respect to stock options and restricted stock awards issued under each of the Lucid Diagnostics 2018 Equity Plan and the PAVmed 2014 Equity Plan, as discussed above, is as follows:

 

   Unrecognized Expense   Weighted Average Remaining Service Period (Years) 
Lucid Diagnostics 2018 Equity Plan          
Stock Options  $3,798    2.0 
Restricted Stock Awards  $1,935    1.6 
PAVmed 2014 Equity Plan          
Stock Options  $109    1.7 
Schedule of Stock-based Compensation Valuation Assumptions

 

   2024   2023 
   Nine Months Ended September 30, 
   2024   2023 
Expected term of stock options (in years)   5.7    5.6 
Expected stock price volatility   73%   75%
Risk free interest rate   4.3%   3.7%
Expected dividend yield   %   %
v3.24.3
Stockholders’ Equity (Tables)
9 Months Ended
Sep. 30, 2024
Equity [Abstract]  
Schedule of Net Loss Attributable to Common Stockholders

 

Series B Convertible Preferred Stock Issuance and Series A/A-1 Exchange Offer  March 13, 2024 
     
Fair Value - 31,790 shares of Series B Preferred Stock issued in exchange for Series A and Series A-1 Preferred Stock  $31,790 
Less: Carrying value related to Series A and Series A-1 Preferred Stock Exchanged for Series B Preferred Stock (of 24,295 shares)   (24,294)
Deemed Dividend Charged to Accumulated Deficit  $7,496 
v3.24.3
Net Loss Per Share (Tables)
9 Months Ended
Sep. 30, 2024
Earnings Per Share [Abstract]  
Schedule of Net Loss Per Share Basic and Diluted

The Net loss per share basic and diluted for the respective periods indicated is as follows:

 

   2024   2023   2024   2023 
  

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

 
   2024   2023   2024   2023 
Numerator                
Net loss  $(12,371)  $(14,208)  $(33,988)  $(41,836)
Deemed dividend on Series A and Series A-1 Convertible Preferred Stock           (7,496)    
Net loss attributable to Lucid Diagnostics Inc. common stockholders  $(12,371)  $(14,208)  $(41,484)  $(41,836)
                     
Denominator                    
Weighted average common shares outstanding, basic and diluted   50,374,146    41,862,805    47,876,015    41,558,979 
                     
Net loss per share (1)                    
Net loss per share - basic and diluted  $(0.25)  $(0.34)  $(0.87)  $(1.01)

 

(1) - Convertible Preferred Stock would potentially be considered a participating security under the two-class method of calculating net loss per share. However, the Company has incurred net losses to-date, and as such holders are not contractually obligated to share in the losses, there is no impact on the Company’s net loss per share calculation for the periods indicated.
Schedule of Common Stock Equivalents Excluded from Computation of Diluted Earnings Per Share

 

   2024   2023 
   September 30, 
   2024   2023 
         
Stock options   8,662,549    4,957,215 
Unvested restricted stock awards   3,897,440    1,787,440 
Preferred stock   51,682,378    13,683,647 
Total   64,242,367    20,428,302 
v3.24.3
Liquidity and Going Concern (Details Narrative) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]          
Revenues $ 1,172 $ 783 $ 3,149 $ 1,388  
Net loss attributable to common stockholders 12,371 $ 14,208 41,484 41,836  
Net cash flows used in operating activities     34,269 $ 22,838  
Working capital 2,600   2,600    
Senior secured convertible note 10,200   10,200   $ 13,950
Cash $ 14,500   $ 14,500    
v3.24.3
Revenue from Contracts with Customers (Details Narrative) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Revenue from Contract with Customer [Abstract]        
Revenue from contract with customer $ 1,172 $ 783 $ 3,149 $ 1,388
Cost of revenue $ 1,684 $ 1,634 $ 4,954 $ 4,522
v3.24.3
Schedule of Due To: PA Vmed Inc (Details)
$ in Thousands
9 Months Ended
Sep. 30, 2024
USD ($)
Short-Term Debt [Line Items]  
Balance - December 31, 2023 $ 9,339
MSA fees 8,150
ERC - Benefits 1,411
On Behalf Of (OBO) activities 598
Cash payments to PAVmed Inc. (14,770)
Payment to PAVmed Inc. settled in LUCD stock (4,675)
Balance - September 30, 2024 53
MSA Fees [Member]  
Short-Term Debt [Line Items]  
Balance - December 31, 2023 6,150
MSA fees 8,150
ERC - Benefits
On Behalf Of (OBO) activities
Cash payments to PAVmed Inc. (12,650)
Payment to PAVmed Inc. settled in LUCD stock (1,650)
Balance - September 30, 2024
ERC Payroll Benefits [Member]  
Short-Term Debt [Line Items]  
Balance - December 31, 2023 3,163
MSA fees
ERC - Benefits 1,411
On Behalf Of (OBO) activities
Cash payments to PAVmed Inc. (1,537)
Payment to PAVmed Inc. settled in LUCD stock (3,025)
Balance - September 30, 2024 12
OBO Payments [Member]  
Short-Term Debt [Line Items]  
Balance - December 31, 2023 26
MSA fees
ERC - Benefits
On Behalf Of (OBO) activities 598
Cash payments to PAVmed Inc. (583)
Payment to PAVmed Inc. settled in LUCD stock
Balance - September 30, 2024 $ 41
v3.24.3
Schedule of MSA Fee Expense Classification in Statements of Operations (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Related Party Transaction [Line Items]        
Total MSA Fee     $ 8,150  
Pavmed Inc [Member] | Management Services Agreement [Member]        
Related Party Transaction [Line Items]        
Total MSA Fee $ 3,150 $ 2,250 8,150 $ 4,500
Pavmed Inc [Member] | Management Services Agreement [Member] | Selling and Marketing Expense [Member]        
Related Party Transaction [Line Items]        
Total MSA Fee 164 109 417 218
Pavmed Inc [Member] | Management Services Agreement [Member] | General and Administrative Expense [Member]        
Related Party Transaction [Line Items]        
Total MSA Fee 2,253 1,554 5,860 3,108
Pavmed Inc [Member] | Management Services Agreement [Member] | Research and Development Expense [Member]        
Related Party Transaction [Line Items]        
Total MSA Fee $ 733 $ 587 $ 1,873 $ 1,174
v3.24.3
Related Party Transactions (Details Narrative) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 27, 2024
Jan. 26, 2024
Sep. 30, 2024
Sep. 30, 2023
Related Party Transaction [Line Items]        
Assignment Fee $ 350      
Management Services Agreement [Member]        
Related Party Transaction [Line Items]        
Monthly payment owed for MSA fees   $ 4,675    
Pavmed Inc [Member]        
Related Party Transaction [Line Items]        
MSA fees per month       $ 750
Monthly fee     $ 1,050 833
Issuance of shares   3,331,771    
Pavmed Inc [Member] | Minimum [Member]        
Related Party Transaction [Line Items]        
MSA fees per month       750
Pavmed Inc [Member] | Maximum [Member]        
Related Party Transaction [Line Items]        
MSA fees per month       $ 833
v3.24.3
Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Prepaid Expenses Deposits And Other Current Assets    
Advanced payments to service providers and suppliers $ 389 $ 266
Prepaid insurance 49 607
Deposits 1,207 1,981
Total prepaid expenses, deposits and other current assets $ 1,645 $ 2,854
v3.24.3
Schedule of Future Lease Payments of Operating Lease Liabilities (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Leases    
2024 (remainder of year) $ 266  
2025 1,025  
2026 979  
2027 940  
2028 19  
Total lease payments 3,229  
Less: imputed interest (363)  
Present value of lease liabilities $ 2,866 $ 1,305
v3.24.3
Schedule of Cash Flow Supplemental Information (Details) - USD ($)
$ in Thousands
9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Leases    
Operating cash flows from operating leases $ 889 $ 894
Right-of-use assets obtained in exchange for new operating lease liabilities $ 2,347 $ 380
Weighted-average remaining lease term - operating leases (in years) 3 years 2 months 1 day 1 year 6 months 29 days
Weighted-average discount rate - operating leases 7.875% 7.875%
v3.24.3
Leases (Details Narrative) - USD ($)
$ in Thousands
9 Months Ended
Sep. 30, 2024
Dec. 31, 2023
Leases    
Rent payments $ 2,600  
Operating lease right of use asset 2,860 $ 1,307
Operating lease obligations 2,866 1,305
Operating lease liabilities, current 855 1,106
Operating lease liabilities, non-current $ 2,011 $ 199
v3.24.3
Schedule of Intangible Assets (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Finite-Lived Intangible Assets [Line Items]    
Total Intangible assets $ 5,305 $ 5,305
Less Accumulated Amortization (4,463) (3,881)
Intangible Assets, net 842 1,424
Defensive Technology [Member]    
Finite-Lived Intangible Assets [Line Items]    
Total Intangible assets $ 2,105 $ 2,105
Estimated useful life 60 months 60 months
Laboratory Information Management Software [Member]    
Finite-Lived Intangible Assets [Line Items]    
Total Intangible assets $ 3,200 $ 3,200
Estimated useful life 24 months 24 months
v3.24.3
Schedule of Future Amortization Expense (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Goodwill and Intangible Assets Disclosure [Abstract]    
2024 (remainder of year) $ 105  
2025 421  
2026 316  
Intangible Assets, net $ 842 $ 1,424
v3.24.3
Intangible Assets, net (Details Narrative) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Goodwill and Intangible Assets Disclosure [Abstract]        
Amortization of Intangible Assets $ 105 $ 505 $ 582 $ 1,516
v3.24.3
Schedule of Financial Liabilities Measured at Fair Value on Recurring Basis (Details) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Fair value of liability [1] $ 10,200 $ 13,950
Fair Value, Inputs, Level 1 [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Fair value of liability [1]
Fair Value, Inputs, Level 2 [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Fair value of liability [1]
Fair Value, Inputs, Level 3 [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Fair value of liability [1] 10,200 13,950
March 2023 Senior Convertible Note [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Fair value of liability [1] 10,200 13,950
March 2023 Senior Convertible Note [Member] | Fair Value, Inputs, Level 1 [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Fair value of liability [1]
March 2023 Senior Convertible Note [Member] | Fair Value, Inputs, Level 2 [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Fair value of liability [1]
March 2023 Senior Convertible Note [Member] | Fair Value, Inputs, Level 3 [Member]    
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]    
Fair value of liability [1] $ 10,200 $ 13,950
[1] There were no transfers between the respective Levels during the nine months ended September 30, 2024.
v3.24.3
Schedule of Fair Value Assumption Used (Details)
$ in Thousands
9 Months Ended 12 Months Ended
Sep. 30, 2024
USD ($)
$ / shares
Dec. 31, 2023
USD ($)
$ / shares
Jun. 30, 2024
USD ($)
Sep. 30, 2023
USD ($)
Jun. 30, 2023
USD ($)
Mar. 21, 2023
USD ($)
Mar. 13, 2023
USD ($)
Dec. 31, 2022
USD ($)
Fair Value Measurement Inputs and Valuation Techniques [Line Items]                
Fair value $ 10,200 $ 13,950            
Face value principal payable 8,669 11,019            
March 2023 Senior Convertible Note [Member]                
Fair Value Measurement Inputs and Valuation Techniques [Line Items]                
Fair value 10,200 13,950 $ 11,200 $ 14,490 $ 11,610    
Face value principal payable $ 8,669 $ 11,019       $ 11,100 $ 11,100  
March 2023 Senior Convertible Note [Member] | Measurement Input Required Rate of Return [Member]                
Fair Value Measurement Inputs and Valuation Techniques [Line Items]                
Fair value assumption measurement input 9.20 10.00            
March 2023 Senior Convertible Note [Member] | Measurement Input, Conversion Price [Member]                
Fair Value Measurement Inputs and Valuation Techniques [Line Items]                
Fair value assumption measurement input | $ / shares 5.00 5.00            
March 2023 Senior Convertible Note [Member] | Measurement Input, Share Price [Member]                
Fair Value Measurement Inputs and Valuation Techniques [Line Items]                
Fair value assumption measurement input | $ / shares 0.82 1.41            
March 2023 Senior Convertible Note [Member] | Measurement Input, Expected Term [Member]                
Fair Value Measurement Inputs and Valuation Techniques [Line Items]                
Expected term years 5 months 19 days 1 year 2 months 19 days            
March 2023 Senior Convertible Note [Member] | Measurement Input, Price Volatility [Member]                
Fair Value Measurement Inputs and Valuation Techniques [Line Items]                
Fair value assumption measurement input 60.00 60.00            
March 2023 Senior Convertible Note [Member] | Measurement Input, Risk Free Interest Rate [Member]                
Fair Value Measurement Inputs and Valuation Techniques [Line Items]                
Fair value assumption measurement input 4.33 4.56            
March 2023 Senior Convertible Note [Member] | Measurement Input, Expected Dividend Rate [Member]                
Fair Value Measurement Inputs and Valuation Techniques [Line Items]                
Fair value assumption measurement input            
v3.24.3
Financial Instruments Fair Value Measurements (Details Narrative) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Mar. 21, 2023
Mar. 13, 2023
Short-Term Debt [Line Items]        
Face value principal payable $ 8,669 $ 11,019    
March 2023 Senior Convertible Note [Member]        
Short-Term Debt [Line Items]        
Face value principal payable $ 8,669 $ 11,019 $ 11,100 $ 11,100
v3.24.3
Summary of Outstanding Debt (Details) - USD ($)
$ / shares in Units, $ in Thousands
9 Months Ended 12 Months Ended
Sep. 21, 2023
Mar. 21, 2023
Sep. 30, 2024
Dec. 31, 2023
Jun. 30, 2024
Sep. 30, 2023
Jun. 30, 2023
Mar. 31, 2023
Mar. 13, 2023
Dec. 31, 2022
Short-Term Debt [Line Items]                    
Conversion Price per Share               $ 0.30    
Face Value Principal Outstanding     $ 8,669 $ 11,019            
Fair Value     $ 10,200 $ 13,950            
March 2023 Senior Convertible Note [Member]                    
Short-Term Debt [Line Items]                    
Contractual Maturity Date Mar. 21, 2025 Mar. 21, 2025 Mar. 21, 2025 Mar. 21, 2025            
Stated Interest Rate   7.875% 7.875% 7.875%            
Conversion Price per Share   $ 5.00 $ 5.00 $ 5.00            
Face Value Principal Outstanding   $ 11,100 $ 8,669 $ 11,019         $ 11,100  
Fair Value     $ 10,200 $ 13,950 $ 11,200 $ 14,490 $ 11,610    
v3.24.3
Schedule of Changes in Fair Value of Debt (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Short-Term Debt [Line Items]        
Fair Value -Beginning Balance     $ 13,950  
Fair Value - Ending Balance $ 10,200   10,200  
Other Income (Expense) - Change in fair value 322 $ 3,021 (568) $ 3,520
Other Operating Income (Expense) [Member]        
Short-Term Debt [Line Items]        
Fair Value -Beginning Balance
Face value principal – issue date    
Fair value adjustment – issue date     (789)
Installment repayments – common stock
Non-installment payments – common stock
Change in fair value (322) (3,021) 568 (2,731)
Fair Value - Ending Balance
Other Income (Expense) - Change in fair value (322) (3,021) 568 (3,520)
March 2023 Senior Convertible Note [Member]        
Short-Term Debt [Line Items]        
Fair Value -Beginning Balance 11,200 11,610 13,950
Face value principal – issue date     11,111
Fair value adjustment – issue date     789
Installment repayments – common stock (1,142) (92) (2,350) (92)
Non-installment payments – common stock (180) (49) (832) (49)
Change in fair value 322 3,021 (568) 2,731
Fair Value - Ending Balance $ 10,200 $ 14,490 $ 10,200 $ 14,490
v3.24.3
Debt (Details Narrative) - USD ($)
$ / shares in Units, $ in Thousands
1 Months Ended 3 Months Ended 9 Months Ended 12 Months Ended
Nov. 08, 2024
Sep. 21, 2023
Mar. 21, 2023
Nov. 12, 2024
Mar. 31, 2023
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Mar. 13, 2023
Short-Term Debt [Line Items]                      
Face value principal payable           $ 8,669   $ 8,669   $ 11,019  
Conversion price         $ 0.30            
Proceeds from convertible debt               $ 10,000    
Contractual conversion price         82.50%            
Gain (Loss) on Extinguishment of Debt           435 $ 26 1,116 26    
March 2023 Senior Convertible Note [Member]                      
Short-Term Debt [Line Items]                      
Face value principal payable     $ 11,100     $ 8,669   $ 8,669   $ 11,019 $ 11,100
Stated interest rate     7.875%     7.875%   7.875%   7.875%  
Conversion price     $ 5.00     $ 5.00   $ 5.00   $ 5.00  
Debt instrument maturity date   Mar. 21, 2025 Mar. 21, 2025         Mar. 21, 2025   Mar. 21, 2025  
Proceeds from convertible debt     $ 9,925                
Debt fees amount     $ 1,186                
Interest expense             $ 149   $ 391    
Principal repayment   $ 292                  
Covenant description               (i) a minimum of $5.0 million of available cash at all times; (ii) the ratio of (a) the outstanding principal amount of the total senior convertible notes outstanding, accrued and unpaid interest thereon and accrued and unpaid late charges to (b) the Company’s average market capitalization over the prior ten trading days, as of the last day of any fiscal quarter commencing with September 30, 2023, to not exceed 30%; and (iii) the Company’s market capitalization to at no time be less than $30 million.      
Debt Instrument, Repaid, Principal           $ 1,142   $ 2,350      
Interest Paid, Including Capitalized Interest, Operating and Investing Activities           $ 180   $ 832      
Debt Conversion, Converted Instrument, Shares Issued           2,116,717   4,777,898      
Debt Conversion, Converted Instrument, Amount           $ 1,755   $ 4,293      
Gain (Loss) on Extinguishment of Debt           $ 435   $ 1,116      
March 2023 Senior Convertible Note [Member] | Subsequent Event [Member]                      
Short-Term Debt [Line Items]                      
Debt Instrument, Repaid, Principal $ 2,415                    
Interest Paid, Including Capitalized Interest, Operating and Investing Activities $ 63                    
Debt Conversion, Converted Instrument, Shares Issued 3,847,321                    
Debt Conversion, Converted Instrument, Amount $ 3,680                    
November 2024 Senior Convertible Notes [Member] | Subsequent Event [Member]                      
Short-Term Debt [Line Items]                      
Stated interest rate 12.00%                    
November 2024 Senior Convertible Notes [Member] | Subsequent Event [Member]                      
Short-Term Debt [Line Items]                      
Proceeds from Issuance of Long-Term Debt       $ 7,700              
v3.24.3
Schedule of Stock Options Issued and Outstanding Activities (Details) - USD ($)
$ / shares in Units, $ in Thousands
9 Months Ended 12 Months Ended
Sep. 30, 2024
Dec. 31, 2023
Share-Based Payment Arrangement [Abstract]    
Number of Stock Options, Outstanding 5,504,383  
Weighted Average Exercise Price, Outstanding $ 2.00  
Remaining Contractual Term (Years) 8 years 3 months 18 days [1] 8 years 6 months
Intrinsic Value, Outstanding [2] $ 765  
Number of Stock Options, Granted [3] 3,604,000  
Weighted Average Exercise Price, Granted [3] $ 1.22  
Number of Stock Options, Exercised (3,333)  
Weighted Average Exercise Price, Exercised $ 1.31  
Number of Stock Options, Forfeited (442,501)  
Weighted Average Exercise Price, Forfeited $ 1.63  
Number of Stock Options, Outstanding 8,662,549 [1] 5,504,383
Weighted Average Exercise Price, Outstanding $ 1.69 [1] $ 2.00
Intrinsic Value, Outstanding [2] $ 197 [1] $ 765
Number of Stock Options, Vested and exercisable stock options 3,654,937  
Weighted Average Exercise Price, Vested and exercisable stock options $ 2.19  
Remaining Contractual Term (Years), Vested and Exercisable stock options 7 years 2 months 12 days  
Intrinsic Value, Vested and exercisable stock options [2] $ 197  
[1] The outstanding stock options presented in the table above are inclusive of 523,300 stock options granted outside the Lucid Diagnostics 2018 Equity Plan, as of September 30, 2024 and December 31, 2023.
[2] The intrinsic value is computed as the difference between the quoted price of the Lucid Diagnostics common stock on each of September 30, 2024 and December 31, 2023 and the exercise price of the underlying Lucid Diagnostics stock options, to the extent such quoted price is greater than the exercise price.
[3] Stock options granted under the Lucid Diagnostics 2018 Equity Plan and those granted outside such plan generally vest one-third in one year then ratably over the next eight quarters, and have a ten-year contractual term from date-of-grant.
v3.24.3
Schedule of Stock Options Issued and Outstanding Activities (Details) (Paranthetical) - shares
9 Months Ended 12 Months Ended
Sep. 30, 2024
Dec. 31, 2023
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Stock option grants [1] 3,604,000  
Outside of 2018 Plan [Member]    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Stock option grants 523,300 523,300
[1] Stock options granted under the Lucid Diagnostics 2018 Equity Plan and those granted outside such plan generally vest one-third in one year then ratably over the next eight quarters, and have a ten-year contractual term from date-of-grant.
v3.24.3
Schedule of Restricted Stock Award Activity (Details) - Restricted Stock [Member]
9 Months Ended
Sep. 30, 2024
$ / shares
shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Number of Restricted Stock Awards, Outstanding | shares 2,337,440 [1]
Weighted Average Grant Date Fair Value, Outstanding | $ / shares $ 8.99 [1]
Number of Restricted Stock Awards, Granted | shares 1,600,000
Weighted Average Grant Date Fair Value, Granted | $ / shares $ 1.03
Number of Restricted Stock Awards, Vested | shares (26,912)
Weighted Average Grant Date Fair Value, Vested | $ / shares $ 4.56
Number of Restricted Stock Awards, Forfeited | shares (13,088)
Weighted Average Grant Date Fair Value, Forfeited | $ / shares $ 4.56
Number of Restricted Stock Awards, Outstanding | shares 3,897,440
Weighted Average Grant Date Fair Value, Outstanding | $ / shares $ 5.77
[1] - Convertible Preferred Stock would potentially be considered a participating security under the two-class method of calculating net loss per share. However, the Company has incurred net losses to-date, and as such holders are not contractually obligated to share in the losses, there is no impact on the Company’s net loss per share calculation for the periods indicated.
v3.24.3
Schedule of Stock-Based Compensation Expense (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]        
Total stock-based compensation expense $ 1,228 $ 1,252 $ 3,363 $ 5,859
2018 Long-Term Incentive Equity Plan [Member] | Cost Of Revenue [Member]        
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]        
Total stock-based compensation expense 30 16 88 44
2018 Long-Term Incentive Equity Plan [Member] | Selling and Marketing Expense [Member]        
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]        
Total stock-based compensation expense 328 228 925 697
2018 Long-Term Incentive Equity Plan [Member] | General and Administrative Expense [Member]        
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]        
Total stock-based compensation expense 699 721 1,635 4,069
2018 Long-Term Incentive Equity Plan [Member] | Research and Development Expense [Member]        
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]        
Total stock-based compensation expense 128 67 386 204
PAVmed Inc 2014 Equity Plan [Member] | Cost Of Revenue [Member]        
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]        
Total stock-based compensation expense 11 10 33 26
PAVmed Inc 2014 Equity Plan [Member] | Selling and Marketing Expense [Member]        
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]        
Total stock-based compensation expense 23 106 141 359
PAVmed Inc 2014 Equity Plan [Member] | General and Administrative Expense [Member]        
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]        
Total stock-based compensation expense 1 7 5 170
PAVmed Inc 2014 Equity Plan [Member] | Research and Development Expense [Member]        
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]        
Total stock-based compensation expense $ 8 $ 97 $ 150 $ 290
v3.24.3
Schedule of Unrecognized Compensation Expense and Weighted Average Remaining Service Period (Details)
$ in Thousands
9 Months Ended
Sep. 30, 2024
USD ($)
Share-Based Payment Arrangement, Option [Member] | 2018 Long-Term Incentive Equity Plan [Member]  
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Unrecognized Expense $ 3,798
Weighted Average Remaining Service Period (Years) 2 years
Share-Based Payment Arrangement, Option [Member] | PAVmed Inc 2014 Equity Plan [Member]  
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Unrecognized Expense $ 109
Weighted Average Remaining Service Period (Years) 1 year 8 months 12 days
Restricted Stock [Member] | 2018 Long-Term Incentive Equity Plan [Member]  
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
Unrecognized Expense $ 1,935
Weighted Average Remaining Service Period (Years) 1 year 7 months 6 days
v3.24.3
Schedule of Stock-based Compensation Valuation Assumptions (Details) - 2018 Long-Term Incentive Equity Plan [Member]
9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Expected term of stock options (in years) 5 years 8 months 12 days 5 years 7 months 6 days
Expected stock price volatility 73.00% 75.00%
Risk free interest rate 4.30% 3.70%
Expected dividend yield
v3.24.3
Stock-Based Compensation (Details Narrative) - USD ($)
$ / shares in Units, $ in Thousands
1 Months Ended 3 Months Ended 9 Months Ended 12 Months Ended
Feb. 22, 2024
May 31, 2024
Jan. 31, 2024
Sep. 30, 2024
Mar. 31, 2024
Sep. 30, 2023
Mar. 31, 2023
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]                    
Stock option grants [1]               3,604,000    
Aggregate fair value of RSA              
Proceeds for issuance       $ 94   $ 275   $ 447 $ 551  
Employees [Member]                    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]                    
Stock options granted 2,895,000                  
Weighted average exercise price $ 1.25                  
Restricted Stock [Member]                    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]                    
Restricted stock awards granted               1,600,000    
2018 Long-Term Incentive Equity Plan [Member]                    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]                    
Number of shares reserved       14,324,038       14,324,038    
Shares available for issue     2,680,038 850,672       850,672    
2018 Long-Term Incentive Equity Plan [Member] | Share-Based Payment Arrangement, Option [Member]                    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]                    
Weighted average estimated fair value               $ 0.79 $ 0.88  
Outside of 2018 Plan [Member]                    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]                    
Stock option grants               523,300   523,300
Outside of 2018 Plan [Member] | Restricted Stock [Member]                    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]                    
Restricted stock awards granted               50,000    
2018 Equity Plan [Member] | Restricted Stock [Member]                    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]                    
Restricted stock awards granted   1,600,000                
Aggregate fair value of RSA   $ 1,500                
Employee Stock Purchase Plan [Member]                    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]                    
Number of shares reserved       1,500,000       1,500,000    
Shares available for issue       259,830       259,830    
Number of common stock purchased       136,056 511,884 276,213 231,987      
Proceeds for issuance       $ 94 $ 353 $ 275 $ 276      
Increase in number of shares available-for-issue     500,000              
[1] Stock options granted under the Lucid Diagnostics 2018 Equity Plan and those granted outside such plan generally vest one-third in one year then ratably over the next eight quarters, and have a ten-year contractual term from date-of-grant.
v3.24.3
Schedule of Net Loss Attributable to Common Stockholders (Details)
$ in Thousands
Mar. 13, 2024
USD ($)
Equity [Abstract]  
Fair Value - 31,790 shares of Series B Preferred Stock issued in exchange for Series A and Series A-1 Preferred Stock $ 31,790
Less: Carrying value related to Series A and Series A-1 Preferred Stock Exchanged for Series B Preferred Stock (of 24,295 shares) (24,294)
Deemed Dividend Charged to Accumulated Deficit $ 7,496
v3.24.3
Schedule of Net Loss Attributable to Common Stockholders (Details) (Parenthetical)
Mar. 13, 2024
shares
Equity [Abstract]  
Fair value of series B preferred stock issued shares 31,790
Less carrying value related to series and series A1 preferred stock exchanged for series B preferred stock shares 24,295
v3.24.3
Stockholders’ Equity (Details Narrative) - USD ($)
$ / shares in Units, $ in Thousands
1 Months Ended 3 Months Ended 9 Months Ended
May 06, 2024
Mar. 13, 2024
Jan. 26, 2024
Oct. 17, 2023
Mar. 07, 2023
Jul. 31, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Jun. 30, 2024
Dec. 31, 2023
Jun. 30, 2023
Dec. 31, 2022
Nov. 30, 2022
Mar. 28, 2022
Class of Stock [Line Items]                              
Preferred stock, per share               $ 0.001     $ 0.001        
Common stock, shares issued               51,597,718     42,329,864        
Common stock, shares outstanding               51,597,718     42,329,864        
Number of new shares issued               480,000              
Number of common shares issued, value             $ 401 $ 147            
Management Services Agreement [Member]                              
Class of Stock [Line Items]                              
Costs and expenses related party     $ 4,675                        
Pavmed Inc [Member]                              
Class of Stock [Line Items]                              
Majority interest equity ownership shares               31,302,444              
Common Stock [Member]                              
Class of Stock [Line Items]                              
Authorized to issue shares description           the Company received shareholder approval to amend its certificate of incorporation, as amended, to increase the total number of shares of common stock the Company is authorized to issue by 100 million shares from 200 million shares to 300 million shares.                  
Majority interest equity ownership shares             42,329,864 51,597,718 42,329,864 49,344,945 42,329,864 41,853,603 40,518,792    
Number of new shares issued               480,000 100,000            
Number of common shares issued, value                          
Common Stock [Member] | Minimum [Member]                              
Class of Stock [Line Items]                              
Weighted average price of common stock   $ 8.00                          
Pavmed Inc [Member]                              
Class of Stock [Line Items]                              
Number of new shares issued     3,331,771                        
Cantor Fitzgerald [Member] | Commited Equity Facility [Member]                              
Class of Stock [Line Items]                              
Common stock authorized for sale                             $ 50,000
Number of shares issued in ATM offering               680,263              
Proceeds from issuance of common stock               $ 1,800              
Percentage of discount on sale of stock               4.00%              
Cantor Fitzgerald [Member] | Controlled Equity Offering Agreement [Member]                              
Class of Stock [Line Items]                              
Common stock authorized for sale                           $ 6,500  
Number of shares issued in ATM offering               230,068              
Proceeds from issuance of shares in ATM offering               $ 300              
Percentage of commission paid to broker               3.00%              
Series B-1 Preferred Stock [Member]                              
Class of Stock [Line Items]                              
Sale of shares   12,495                          
Conversion price $ 0.7228                            
Gross proceeds from the sale of shares $ 11,600                            
Preferred stock, shares issued 11,634             55,919              
Preferred stock shares outstanding               55,919              
Series B Preferred Stock [Member]                              
Class of Stock [Line Items]                              
Sale of shares   31,790                          
Preferred stock, per share   $ 0.001                          
Weighted average price of common stock   1,000                          
Preferred stock, stated value   1,000                          
Conversion price   $ 1.2444                          
Gross proceeds from the sale of shares   $ 18,100                          
Preferred stock dividend payment terms   The holders of Series B Preferred Stock will be entitled to dividends payable as follows: (i) a number of shares of Common Stock equal to 20% of the number of shares of Common Stock issuable upon conversion of the Series B Preferred Stock then held by such Holder on March 13, 2025, and (ii) a number of shares of Common Stock equal to 20% of the number of shares of Common Stock issuable upon conversion of the Series B Preferred Stock then held by such Holder on March 13, 2026. A holder that voluntarily converts its Series B Preferred Stock prior to March 13, 2025 or March 13, 2026, as the case may be, will not receive the dividend that accrues on such date with respect to such converted Series B Preferred Stock. The holders of the Series B Preferred Stock also will be entitled to dividends equal, on an as-if-converted to shares of Common Stock basis, to and in the same form as dividends actually paid on shares of the Common Stock when, as, and if such dividends are paid on shares of the Common Stock.                          
Conversion of stock, description   The Company will not effect any conversion of the Series B Preferred Stock, and a holder will not have the right to receive dividends or convert any portion of the Series B Preferred Stock, to the extent that, after giving effect to the receipt of dividends or the conversion, the holder (together with such holder’s affiliates, and any persons acting as a group together with such holder or any of the holder’s affiliates) would beneficially own in excess of 4.99% of the Company’s outstanding common stock (or, upon election of the holder, 9.99% of the Company’s outstanding common stock).                          
Preferred stock, shares issued               55,919              
Preferred stock shares outstanding               55,919              
Series A Preferred Stock [Member]                              
Class of Stock [Line Items]                              
Sale of shares   13,625                          
Preferred stock, per share   $ 0.001     $ 0.001                    
Conversion price         $ 1.394                    
Right to receive dividend percentage   20.00%                          
Gross proceeds from the sale of shares         $ 13,600                    
Preferred stock, shares issued         13,625           18,625        
Preferred stock shares outstanding                     18,625        
Series A-1 Preferred Stock [Member]                              
Class of Stock [Line Items]                              
Sale of shares   10,670                          
Preferred stock, per share   $ 0.001                          
Conversion price       $ 1.2592                      
Gross proceeds from the sale of shares       $ 5,000                      
Preferred stock, shares issued   5,670   5,000             18,625        
Preferred stock shares outstanding   0                 18,625        
Series A-1 Preferred Stock [Member] | Investor [Member]                              
Class of Stock [Line Items]                              
Sale of shares   5,670                          
Weighted average price of common stock   $ 1,000                          
Series B Convertible Preferred Stock [Member]                              
Class of Stock [Line Items]                              
Preferred Stock Dividends, Shares               31,790              
Series A and A-1 Convertible Preferred Stock [Member]                              
Class of Stock [Line Items]                              
Issuance exchange - majority-owned subsidiary preferred stock Series A and Series A one   $ 24,294                          
Fair value of deemed dividend   $ 7,500                          
v3.24.3
Schedule of Net Loss Per Share Basic and Diluted (Details) - USD ($)
$ / shares in Units, $ in Thousands
3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Earnings Per Share [Abstract]        
Net loss $ (12,371) $ (14,208) $ (33,988) $ (41,836)
Deemed dividend on Series A and Series A-1 Convertible Preferred Stock (7,496)
Net loss attributable to Lucid Diagnostics Inc. common stockholders $ (12,371) $ (14,208) $ (41,484) $ (41,836)
Weighted average common shares outstanding, basic 50,374,146 41,862,805 47,876,015 41,558,979
Weighted average common shares outstanding, diluted 50,374,146 41,862,805 47,876,015 41,558,979
Net loss per share - basic [1] $ (0.25) $ (0.34) $ (0.87) $ (1.01)
Net loss per common share - diluted [1] $ (0.25) $ (0.34) $ (0.87) $ (1.01)
[1] - Convertible Preferred Stock would potentially be considered a participating security under the two-class method of calculating net loss per share. However, the Company has incurred net losses to-date, and as such holders are not contractually obligated to share in the losses, there is no impact on the Company’s net loss per share calculation for the periods indicated.
v3.24.3
Schedule of Common Stock Equivalents Excluded from Computation of Diluted Earnings Per Share (Details) - shares
9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Total 64,242,367 20,428,302
Share-Based Payment Arrangement, Option [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Total 8,662,549 4,957,215
Unvested Restricted Stock Awards [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Total 3,897,440 1,787,440
Preferred Stock [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Total 51,682,378 13,683,647

Lucid Diagnostics (NASDAQ:LUCD)
過去 株価チャート
から 12 2024 まで 1 2025 Lucid Diagnosticsのチャートをもっと見るにはこちらをクリック
Lucid Diagnostics (NASDAQ:LUCD)
過去 株価チャート
から 1 2024 まで 1 2025 Lucid Diagnosticsのチャートをもっと見るにはこちらをクリック