Close

Form 6-K Renalytix plc For: Jun 30

June 30, 2022 7:02 AM EDT

Get instant alerts when news breaks on your stocks. Claim your 1-week free trial to StreetInsider Premium here.
6-K
--06-300001811115false0.080001811115rnlx:MilestoneOneMemberrnlx:JoslinLicenseMember2022-03-310001811115us-gaap:AdditionalPaidInCapitalMember2021-10-012021-12-310001811115rnlx:KantaroBioSciencesLlcMember2021-07-012022-03-310001811115us-gaap:ParentMember2021-01-012021-03-310001811115us-gaap:GeneralAndAdministrativeExpenseMemberrnlx:AdvisoryAgreementMemberrnlx:KantaroBioSciencesLlcMember2021-01-012021-03-310001811115us-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMember2021-06-300001811115us-gaap:ResearchAndDevelopmentExpenseMember2021-01-012021-03-310001811115us-gaap:ParentMemberus-gaap:IPOMember2020-07-012020-09-300001811115rnlx:AdvisoryAgreementMemberrnlx:KantaroBioSciencesLlcMember2021-07-012022-03-310001811115us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-01-012022-03-310001811115rnlx:SafeharborplanMember2020-07-012021-03-310001811115us-gaap:ParentMember2020-10-012020-12-310001811115rnlx:IcahnSchoolOfMedicineAtMountShenaiMember2022-03-310001811115rnlx:MountSinaiMember2021-07-012022-03-310001811115us-gaap:AdditionalPaidInCapitalMember2021-07-012021-09-300001811115rnlx:AdvisoryAgreementMemberrnlx:KantaroBioSciencesLlcMember2022-01-012022-03-310001811115rnlx:IcahnSchoolOfMedicineAtMountShenaiMember2021-01-012021-03-310001811115rnlx:KantaroBioSciencesLlcMember2020-07-012021-03-310001811115rnlx:OtherServicesRevenueMemberus-gaap:TransferredAtPointInTimeMember2021-01-012021-03-310001811115us-gaap:RetainedEarningsMember2021-03-310001811115us-gaap:GeneralAndAdministrativeExpenseMember2022-01-012022-03-310001811115rnlx:SafeharborplanMember2022-01-012022-03-310001811115us-gaap:FurnitureAndFixturesMember2022-03-310001811115rnlx:EquityIncentivePlanMember2022-03-310001811115rnlx:RenalytixAiPlcShareOptionPlanMember2022-03-310001811115us-gaap:RetainedEarningsMember2020-07-012020-09-300001811115rnlx:VericiDxLimitedMember2020-07-012021-03-3100018111152022-04-300001811115us-gaap:NoncontrollingInterestMember2020-10-012020-12-3100018111152020-12-310001811115rnlx:MountSinaiMemberus-gaap:CapitalUnitClassAMember2022-03-310001811115rnlx:MountSinaiMemberrnlx:ISSMSAndSRAMember2022-01-012022-03-3100018111152022-06-302022-06-300001811115rnlx:AdvisoryAgreementMemberrnlx:KantaroBioSciencesLlcMember2021-01-012021-03-310001811115us-gaap:AdditionalPaidInCapitalMember2021-06-300001811115rnlx:EkfDiagnosticsMember2021-01-012021-03-310001811115us-gaap:AdditionalPaidInCapitalMember2020-07-012020-09-300001811115rnlx:MasterCareCoordinationServicesAgreementMemberrnlx:DavitaIncMember2021-01-312021-01-310001811115us-gaap:ValuationTechniqueDiscountedCashFlowMemberrnlx:AdvisoryAgreementMemberus-gaap:CapitalUnitClassAMemberus-gaap:FairValueInputsLevel3Memberrnlx:KantaroBioSciencesLlcMember2022-03-310001811115us-gaap:RetainedEarningsMember2020-12-310001811115us-gaap:ParentMember2021-03-310001811115us-gaap:CommonStockMember2021-12-310001811115us-gaap:AdditionalPaidInCapitalMember2021-12-310001811115rnlx:EmployeeSharePurchasePlanmemberMember2022-03-310001811115us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-09-300001811115rnlx:MountSinaiMembersrt:MinimumMemberrnlx:ISSMSAndSRAMemberrnlx:MilestoneThreeMember2021-07-012022-03-310001811115srt:MaximumMemberrnlx:EmployeeSharePurchasePlanmemberMember2021-07-012022-03-310001811115rnlx:MountSinaiMemberrnlx:MilestoneOneMemberrnlx:ISSMSAndSRAMember2022-03-310001811115rnlx:MountSinaiMemberrnlx:MountSinaicovid19sponsoredResearchAgreementMemberrnlx:MulticenterAssessmentOfSurvivorsForKidneyDiseaseAftercovid19studyMember2020-07-012021-03-310001811115us-gaap:NoncontrollingInterestMember2020-07-012020-09-300001811115us-gaap:SoftwareAndSoftwareDevelopmentCostsMember2022-03-310001811115us-gaap:CommonStockMemberus-gaap:IPOMember2020-07-012020-09-3000018111152022-04-012022-04-300001811115rnlx:SafeharborplanMember2021-07-012022-03-310001811115us-gaap:AccumulatedOtherComprehensiveIncomeMember2020-10-012020-12-310001811115us-gaap:GeneralAndAdministrativeExpenseMember2020-07-012021-03-310001811115rnlx:JoslinLicenseMemberrnlx:MilestoneThreeMember2021-07-012022-03-310001811115rnlx:VericiDxLimitedMember2020-10-012021-06-3000018111152021-01-012021-03-310001811115us-gaap:NoncontrollingInterestMember2020-09-300001811115us-gaap:NoncontrollingInterestMember2021-03-310001811115rnlx:AdvisoryAgreementMemberrnlx:KantaroBioSciencesLlcMember2022-03-310001811115us-gaap:ParentMember2020-06-300001811115us-gaap:AdditionalPaidInCapitalMember2021-01-012021-03-310001811115rnlx:MountSinaiMemberrnlx:MountSinaicovid19sponsoredResearchAgreementMemberrnlx:MulticenterAssessmentOfSurvivorsForKidneyDiseaseAftercovid19studyMember2022-01-012022-03-310001811115rnlx:MountSinaiMemberrnlx:MilestoneTwoMemberrnlx:ISSMSAndSRAMember2021-07-012022-03-310001811115us-gaap:GeneralAndAdministrativeExpenseMember2021-07-012022-03-310001811115us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-06-300001811115rnlx:EquityIncentivePlanMemberrnlx:OneTwelvethVestOnTheOneYearAnniversaryMemberus-gaap:RestrictedStockMember2021-07-012022-03-310001811115us-gaap:AccumulatedOtherComprehensiveIncomeMember2020-07-012020-09-300001811115srt:MaximumMember2022-03-310001811115us-gaap:ParentMember2020-07-012020-09-3000018111152021-10-012021-12-310001811115us-gaap:ResearchAndDevelopmentExpenseMember2020-07-012021-03-310001811115rnlx:MountSinaiMemberrnlx:ISSMSAndSRAMember2021-01-012021-03-310001811115rnlx:MountSinaiMemberrnlx:ISSMSAndSRAMember2021-07-012022-03-310001811115us-gaap:CommonStockMember2020-09-300001811115us-gaap:AdditionalPaidInCapitalMember2020-10-012020-12-3100018111152022-01-012022-03-310001811115rnlx:KantaroBioSciencesLlcMember2021-06-300001811115us-gaap:RetainedEarningsMember2021-10-012021-12-310001811115rnlx:VericiDxLimitedMember2021-07-012022-03-310001811115us-gaap:ConstructionInProgressMember2021-06-300001811115us-gaap:ValuationTechniqueDiscountedCashFlowMemberrnlx:AdvisoryAgreementMemberus-gaap:FairValueInputsLevel3Memberrnlx:KantaroBioSciencesLlcMember2022-03-310001811115us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-03-310001811115us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-07-012021-09-300001811115rnlx:AmericanDepositarySharesMember2022-04-012022-04-300001811115us-gaap:MachineryAndEquipmentMember2021-06-300001811115us-gaap:RetainedEarningsMember2021-12-310001811115us-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMember2022-03-310001811115rnlx:MountSinaiMemberrnlx:KantaroBioSciencesLlcMember2022-03-310001811115rnlx:VericiDxLimitedMember2022-01-012022-03-310001811115us-gaap:AdditionalPaidInCapitalMember2022-01-012022-03-3100018111152020-06-302021-06-300001811115rnlx:MilestoneTwoMemberrnlx:JoslinLicenseMemberrnlx:LicensedProductsMember2021-07-012022-03-310001811115us-gaap:GeneralAndAdministrativeExpenseMemberrnlx:EmployeeSharePurchasePlanmemberMember2022-01-012022-03-310001811115us-gaap:CommonStockMember2020-06-300001811115rnlx:MountSinaiMemberrnlx:MilestoneTwoMemberrnlx:ISSMSAndSRAMember2022-03-310001811115us-gaap:ResearchAndDevelopmentExpenseMember2022-01-012022-03-3100018111152021-09-300001811115rnlx:EquityIncentivePlanMemberus-gaap:RestrictedStockMember2021-07-012022-03-310001811115us-gaap:ResearchAndDevelopmentExpenseMember2021-07-012022-03-3100018111152021-03-310001811115rnlx:SafeharborplanMember2021-01-012021-03-310001811115us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-10-012021-12-310001811115us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2022-03-310001811115rnlx:PharmaceuticalServicesRevenueMemberus-gaap:TransferredAtPointInTimeMember2021-07-012022-03-3100018111152021-07-012022-03-310001811115us-gaap:RetainedEarningsMember2020-06-300001811115rnlx:MountSinaiMemberrnlx:MountSinaicovid19sponsoredResearchAgreementMemberrnlx:MulticenterAssessmentOfSurvivorsForKidneyDiseaseAftercovid19studyMember2022-03-312022-03-310001811115us-gaap:CommonStockMember2021-10-012021-12-310001811115us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-03-310001811115us-gaap:RetainedEarningsMember2021-09-300001811115us-gaap:AdditionalPaidInCapitalMember2021-09-300001811115rnlx:AdvisoryAgreementMemberus-gaap:GeneralAndAdministrativeExpenseMemberrnlx:KantaroBioSciencesLlcMember2022-01-012022-03-310001811115us-gaap:AdditionalPaidInCapitalMember2021-03-310001811115rnlx:AdvisoryAgreementMemberus-gaap:GeneralAndAdministrativeExpenseMemberrnlx:KantaroBioSciencesLlcMember2021-07-012022-03-310001811115us-gaap:CommonStockMember2021-03-310001811115rnlx:MountSinaiMembersrt:MinimumMemberrnlx:ISSMSAndSRAMember2021-07-012022-03-310001811115rnlx:MountSinaiMembersrt:MaximumMemberrnlx:ISSMSAndSRAMemberrnlx:MilestoneThreeMember2021-07-012022-03-310001811115rnlx:OtherServicesRevenueMemberus-gaap:TransferredAtPointInTimeMember2020-07-012021-03-310001811115rnlx:MasterCareCoordinationServicesAgreementMemberrnlx:DavitaIncMember2021-07-012022-03-310001811115rnlx:MountSinaiMemberrnlx:MountSinaicovid19sponsoredResearchAgreementMemberrnlx:MulticenterAssessmentOfSurvivorsForKidneyDiseaseAftercovid19studyMember2021-07-012022-03-310001811115us-gaap:AdditionalPaidInCapitalMember2020-09-300001811115us-gaap:ParentMember2020-12-3100018111152022-03-310001811115us-gaap:OfficeEquipmentMember2021-06-300001811115us-gaap:CommonStockMember2021-01-012021-03-310001811115rnlx:VericiDxLimitedMember2022-03-310001811115rnlx:AdvisoryAgreementMemberus-gaap:ResearchAndDevelopmentExpenseMemberrnlx:KantaroBioSciencesLlcMember2021-01-012021-03-310001811115rnlx:KantaroBioSciencesLlcMember2022-03-310001811115us-gaap:GeneralAndAdministrativeExpenseMemberrnlx:EmployeeSharePurchasePlanmemberMember2020-07-012021-03-310001811115rnlx:TestingServicesRevenueMemberus-gaap:TransferredAtPointInTimeMember2022-01-012022-03-310001811115us-gaap:EmployeeStockOptionMember2020-07-012021-03-310001811115rnlx:VericiDxLimitedMember2021-06-300001811115rnlx:KantaroBioSciencesLlcMember2022-01-012022-03-310001811115rnlx:PharmaceuticalServicesRevenueMemberus-gaap:TransferredAtPointInTimeMember2021-01-012021-03-310001811115rnlx:PharmaceuticalServicesRevenueMemberus-gaap:TransferredAtPointInTimeMember2020-07-012021-03-310001811115rnlx:ProfessionalServicesRevenueMemberus-gaap:TransferredAtPointInTimeMember2021-07-012022-03-310001811115us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2021-06-300001811115us-gaap:EmployeeStockOptionMember2021-07-012022-03-310001811115rnlx:EkfDiagnosticsMember2022-01-012022-03-310001811115rnlx:IcahnSchoolOfMedicineAtMountShenaiMember2022-01-012022-03-310001811115rnlx:PharmaceuticalServicesRevenueMemberus-gaap:TransferredAtPointInTimeMember2022-01-012022-03-310001811115us-gaap:FurnitureAndFixturesMember2021-06-300001811115us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-01-012021-03-310001811115us-gaap:AdditionalPaidInCapitalMember2020-06-300001811115us-gaap:AdditionalPaidInCapitalMember2020-12-310001811115us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-12-310001811115us-gaap:RetainedEarningsMember2020-10-012020-12-310001811115us-gaap:IPOMember2020-07-012020-09-300001811115rnlx:KantaroBioSciencesLlcMemberrnlx:CommitmentToLendAdditionalAmountMember2022-03-310001811115us-gaap:AdditionalPaidInCapitalMember2022-03-310001811115us-gaap:LeaseholdImprovementsMember2022-03-310001811115us-gaap:CommonStockMember2021-09-300001811115us-gaap:MachineryAndEquipmentMember2022-03-3100018111152021-06-300001811115us-gaap:LeaseholdImprovementsMember2021-06-3000018111152020-07-012020-09-300001811115rnlx:MilestoneTwoMemberrnlx:JoslinLicenseMember2022-03-310001811115rnlx:MountSinaiMemberrnlx:MilestoneOneMemberrnlx:ISSMSAndSRAMember2021-07-012022-03-310001811115us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2022-03-310001811115rnlx:AmericanDepositarySharesMember2022-04-300001811115rnlx:AdvisoryAgreementMemberus-gaap:ResearchAndDevelopmentExpenseMemberrnlx:KantaroBioSciencesLlcMember2021-07-012022-03-310001811115us-gaap:GeneralAndAdministrativeExpenseMemberrnlx:EmployeeSharePurchasePlanmemberMember2021-07-012022-03-310001811115us-gaap:CommonStockMember2022-03-310001811115us-gaap:ConstructionInProgressMember2022-03-3100018111152021-07-012021-09-300001811115rnlx:RenalytixAiPlcShareOptionPlanMember2020-07-012021-03-310001811115rnlx:RenalytixAiPlcShareOptionPlanMember2021-07-012022-03-310001811115rnlx:ProfessionalServicesRevenueMemberus-gaap:TransferredAtPointInTimeMember2022-01-012022-03-3100018111152020-10-012020-12-310001811115us-gaap:SoftwareAndSoftwareDevelopmentCostsMember2021-06-300001811115rnlx:TestingServicesRevenueMemberus-gaap:TransferredAtPointInTimeMember2021-07-012022-03-310001811115rnlx:AdvisoryAgreementMemberrnlx:KantaroBioSciencesLlcMember2020-07-012021-03-3100018111152020-07-012021-03-310001811115rnlx:EkfDiagnosticsMember2020-07-012021-03-310001811115rnlx:AdvisoryAgreementMemberus-gaap:CapitalUnitClassAMemberrnlx:KantaroBioSciencesLlcMember2022-03-3100018111152020-09-300001811115rnlx:TestingServicesRevenueMemberus-gaap:TransferredAtPointInTimeMember2020-07-012021-03-310001811115us-gaap:CommonStockMember2021-07-012021-09-300001811115us-gaap:AccumulatedOtherComprehensiveIncomeMember2020-06-300001811115us-gaap:ParentMember2020-09-300001811115us-gaap:AccumulatedOtherComprehensiveIncomeMember2020-12-310001811115srt:MinimumMemberrnlx:EmployeeSharePurchasePlanmemberMember2021-07-012022-03-310001811115rnlx:MilestoneOneMemberrnlx:JoslinLicenseMemberrnlx:LicensedProductsMember2021-07-012022-03-310001811115us-gaap:RetainedEarningsMember2020-09-300001811115us-gaap:RetainedEarningsMember2021-06-300001811115rnlx:CompoundedMonthlyMemberrnlx:KantaroBioSciencesLlcMember2022-01-012022-03-310001811115rnlx:TestingServicesRevenueMemberus-gaap:TransferredAtPointInTimeMember2021-01-012021-03-3100018111152021-01-012021-06-300001811115us-gaap:AccumulatedOtherComprehensiveIncomeMember2020-09-300001811115us-gaap:AdditionalPaidInCapitalMemberus-gaap:IPOMember2020-07-012020-09-300001811115rnlx:EmployeeSharePurchasePlanmemberMember2021-07-012022-03-310001811115rnlx:AdvisoryAgreementMemberus-gaap:ResearchAndDevelopmentExpenseMemberrnlx:KantaroBioSciencesLlcMember2022-01-012022-03-310001811115rnlx:VericiDxLimitedMember2021-01-012021-03-310001811115rnlx:EkfDiagnosticsMember2021-07-012022-03-310001811115rnlx:KantaroBioSciencesLlcMember2021-01-012021-03-310001811115us-gaap:RetainedEarningsMember2022-03-310001811115rnlx:IcahnSchoolOfMedicineAtMountShenaiMember2020-07-012021-03-310001811115rnlx:IcahnSchoolOfMedicineAtMountShenaiMember2021-07-012022-03-310001811115us-gaap:RetainedEarningsMember2021-01-012021-03-310001811115us-gaap:GeneralAndAdministrativeExpenseMemberrnlx:AdvisoryAgreementMemberrnlx:KantaroBioSciencesLlcMember2020-07-012021-03-3100018111152021-12-3100018111152020-06-300001811115rnlx:JoslinLicenseMember2022-03-310001811115rnlx:MountSinaiMemberrnlx:MountSinaicovid19sponsoredResearchAgreementMemberrnlx:MulticenterAssessmentOfSurvivorsForKidneyDiseaseAftercovid19studyMember2021-01-012021-03-310001811115rnlx:MountSinaiMemberrnlx:ISSMSAndSRAMember2020-07-012021-03-310001811115us-gaap:GeneralAndAdministrativeExpenseMemberrnlx:EmployeeSharePurchasePlanmemberMember2021-01-012021-03-310001811115rnlx:MountSinaiMembersrt:MaximumMemberrnlx:ISSMSAndSRAMember2021-07-012022-03-310001811115us-gaap:GeneralAndAdministrativeExpenseMember2021-01-012021-03-310001811115us-gaap:CommonStockMember2020-12-310001811115rnlx:JoslinLicenseMember2021-07-012022-03-310001811115us-gaap:CommonStockMember2021-06-300001811115us-gaap:RetainedEarningsMember2021-07-012021-09-3000018111152020-07-012021-06-300001811115us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2021-06-300001811115us-gaap:RetainedEarningsMember2022-01-012022-03-310001811115rnlx:AdvisoryAgreementMemberus-gaap:ResearchAndDevelopmentExpenseMemberrnlx:KantaroBioSciencesLlcMember2020-07-012021-03-310001811115us-gaap:OfficeEquipmentMember2022-03-31xbrli:pureiso4217:GBPxbrli:sharesxbrli:sharesiso4217:USDxbrli:sharesiso4217:USD

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 6-K

 

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

Date of report: June 30, 2022

Commission File Number: 001-39387

 

 

Renalytix plc

(Translation of registrant’s name into English)

 

 

Finsgate

5-7 Cranwood Street

London EC1V 9EE

United Kingdom

(Address of principal executive office)

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F: ☒ Form 20-F ☐ Form 40-F

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐

 

 

 

 


 

INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K

On June 30, 2022 Renalytix plc issued a press release regarding its financial results as of and for the three and nine months ended March 31, 2022, which is furnished as Exhibit 99.1 to this Report on Form 6-K.

EXHIBIT INDEX

Exhibit

 

Description

 

 

99.1

 

Press release dated June 30, 2022.

 

101

 

The following materials from this Report on Form 6-K are formatted in XBRL (eXtensible Business Reporting Language): (i) Condensed Consolidated Balance Sheets (Unaudited) as of March 31, 2022 and June 30, 2021, (ii) Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) for the Three and Nine Months Ended March 31, 2022 and 2021, (iii) Condensed Consolidated Statements of Shareholders’ Equity (Unaudited) for the Three and Nine Months Ended March 31, 2022 and 2021, (iv) Condensed Consolidated Statements of Cash Flows (Unaudited) for the Nine Months Ended March 31, 2022 and 2021, and (v) Notes to Condensed Consolidated Financial Statements (Unaudited).

 

104

 

Cover page Interactive Data File (embedded with the Inline XBRL document)

 

 


SIGNATURES

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

 

RENALYTIX PLC

 

 

By:

 

/s/ James McCullough

 

 

James McCullough

 

 

Chief Executive Officer

Date: June 30, 2022


Exhibit 99.1

Renalytix plc

(“Renalytix” or the “Company”)

 

Renalytix Reports Financial Results for Third Quarter of Fiscal Year 2022

 

LONDON and SALT LAKE CITY, June 30, 2022 – Renalytix plc (NASDAQ: RNLX) (LSE: RENX), an artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney disease to drive improved patient outcomes and advance value-based care, today reported financial results for the quarter ended March 31, 2022.

 

Recent Highlights (including post period events)

Successful completion of $30.0 million financing package ($26.8 million gross proceeds)
Multiple data presentations at the American Diabetes Association (ADA) 82nd Scientific Sessions® meeting
Focused on the value of KidneyIntelX testing in patients with type 2 diabetes (T2D) and early-stage chronic kidney disease (CKD):
o
KidneyIntelX ability to assess risk of heart failure hospitalization and death in large international diabetic kidney disease patient cohort (also published in Kidney360)
o
KidneyIntelX testing in 1,112 adult diabetic kidney disease (DKD) patients at Mount Sinai Health System demonstrated utility in driving guideline appropriate use of therapies, including SGLT-2 inhibitors and RAAS inhibitor use, and timely consultation to specialists in high-risk patients.
Continued KidneyIntelX testing volume growth
Over 3,000 KidneyIntelX risk scores generated for Mount Sinai Health System patients and over 300 at Wake Forest Baptist Health
33 state Medicaid programs contracted to date
New coverage for KidneyIntelX by the largest private payer in Illinois with 8.1 million members
KidneyIntelX coverage from the largest independent provider network in North Carolina, South Carolina and Virginia, with over 100,000 health care providers in-network

Third Quarter 2022 Financial Results

During the three months ended March 31, 2022, the Company recognized $0.8 million of revenue (Q3 FY21: $0.6 million). Cost of revenue for the three months ended March 31, 2022 was $0.7 million (Q3 FY21: $0.2 million).

Operating expense for the three months ended March 31, 2022 was $14.7 million compared to $8.5 million during the prior year period.

Within operating expenses, research and development expenses were $3.9 million for the three months ended March 31, 2022, an increase of $0.8 million, from $3.1 million for the three months ended March 31, 2021. The increase was driven by employee related expenses, lab supplies and professional fees associated with the utility studies at Mount Sinai, Wake Forest and University of Utah.

General and administrative expenses were $10.8 million for the three months ended March 31, 2022, increasing by $5.3 million from $5.5 million for the three months ended March 31, 2021. The increase was primarily due to a $4.3 million increase in compensation, reimbursable expenses and related benefits, including share-based payments, due to increased headcount, a $0.7 million increase in consulting and professional fees including marketing expense, a $0.2 million increase in computers, software and IT costs, and a $0.1 million increase in other operating expenses.

Net loss attributable to ordinary shareholders was $14.7 million for the three months ended March 31, 2022 compared to $8.8 million for the prior year period.

Cash and cash equivalents totaled $32.4 million as of March 31, 2022. This was prior to the completion of the $26.8 million (gross) financing package, further details of which were announced on March 31, 2022, which completed post-period end on April 8, 2022.

The Company also intends to file with the Securities and Exchange Commission a shelf registration statement on Form F-3 pursuant to which the Company may offer and sell up to $300 million of its ordinary shares, ordinary shares in the form of ADSs, debt securities and warrants, including the intention to enter into a sales agreement with a sales agent pursuant to which the Company may sell, from time to time, at its option, up to $50 million of ADSs through the sales agent in “at the market” transactions on Nasdaq.


The Company will host a corresponding conference call and live webcast today to discuss the financial results and key topics including business strategy, partnerships and regulatory and reimbursement processes, at 8:30 a.m. (ET) / 1:30 p.m. (GMT).

Conference Call Details:
US/Canada Participant Toll-Free Dial-In Number: (833) 614-1551
US/Canada Participant International Dial-In Number: (914) 987-7290
United Kingdom International Dial-In Number: 0800 0288 438
United Kingdom Local Dial-In Number: 0203 1070 289
Conference ID: 1546327

Webcast Registration link: https://edge.media-server.com/mmc/p/y3zwhkuk

For further information, please contact:

 

Renalytix plc

www.renalytix.com

James McCullough, CEO

Via Walbrook PR

 

 

Stifel (Nominated Adviser, Joint Broker)

Tel: 020 7710 7600

Alex Price / Nicholas Moore

 

 

 

Investec Bank plc (Joint Broker)

Tel: 020 7597 4000

Gary Clarence / Daniel Adams

 

 

 

Walbrook PR Limited

Tel: 020 7933 8780 or [email protected]

Paul McManus / Lianne Applegarth / Alice Woodings

Mob: 07980 541 893 / 07584 391 303 / 07407 804 654

 

 

CapComm Partners

 

Peter DeNardo

 

Tel: 415-389-6400 or [email protected]

 

About Renalytix

Renalytix (LSE: RENX) (NASDAQ: RNLX) is the global founder and leader in the new field of bioprognosis™ for kidney health. The company has engineered a new solution that enables early-stage chronic kidney disease progression risk assessment. The Company’s lead product, KidneyIntelX™, has been granted Breakthrough Designation by the U.S. Food and Drug Administration and is designed to help make significant improvements in kidney disease prognosis, transplant management, clinical care, patient stratification for drug clinical trials, and drug target discovery (visit www.kidneyintelx.com). For more information, visit www.renalytix.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Examples of these forward-looking statements include statements concerning: the commercial prospects of KidneyIntelX, including whether KidneyIntelX will be successfully adopted by physicians and distributed and marketed, the rate of testing with KidneyIntelX in health care systems, expectations and timing of announcement of real-world testing evidence, the potential for KidneyIntelX to be approved for additional indications, our expectations regarding regulatory and reimbursement decisions, the ability of KidneyIntelX to curtail costs of chronic and end-stage kidney disease, optimize care delivery and improve patient outcomes, and our expectations and guidance related to partnerships, testing volumes and revenue for future periods. Words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “plans,” “seeks,” and similar expressions are intended to identify forward-looking statements. We may not actually achieve the plans and objectives disclosed in the forward-looking statements, and you should not place undue reliance on our forward-looking statements. Any forward-looking statements are based on management’s current views and assumptions and involve risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, among others: that KidneyIntelX is based on novel artificial intelligence technologies that are rapidly evolving and potential acceptance, utility and clinical practice remains uncertain; we have only recently commercially launched KidneyIntelX; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises. These and other risks are described more fully in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our annual report on Form 20-F filed with the SEC on October 21, 2021, and other filings we make with the SEC from time to time. All information in this press release is as of the date of the release, and we undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.

 


RENALYTIX PLC

 

Operational Update and Financial Results for the three and nine months ended March 31, 2022

 

Unless otherwise indicated, all references in this report, to the terms “Renalytix,” “Renalytix plc,” “the company,” “we,” “us” and “our” refer to Renalytix plc together with its subsidiaries. We recommend that you read the discussion below together with our audited financial statements and the notes thereto, which appear in our Annual Report on Form 20-F for the year ended June 30, 2021, filed with the Securities and Exchange Commission on October 21, 2021 (our “Annual Report”).

The statements in this discussion regarding our expectations regarding our market opportunity, partnerships, reimbursement, regulatory approval, cash runway, revenue guidance, capital requirements and future performance, as well as all other non-historical statements are forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of our Annual Report and any subsequent reports that we file with the SEC. See also the section titled “Forward-Looking Statements” above.

OPERATIONAL REVIEW

About Renalytix

At Renalytix, we are helping lead the charge to introduce simple, more accurate prognosis and effective care management for the estimated 850 million people worldwide with chronic kidney disease. In the United States alone, chronic kidney disease affects close to an estimated 37 million people and is responsible for one of the largest cost drivers in the national medical system. Early identification, prognosis and treatment beginning with primary care physicians is essential if we are to stem the growing social cost and suffering associated with kidney disease.

With our lead product, KidneyIntelX, our goal is to shift the conversation from kidney disease to kidney health through a more accurate understanding of early-stage risk. With the deployment of KidneyIntelX this year, Renalytix has become a global leader in the new field of bioprognosis, a biology-driven approach to risk assessment that relies on integrating information from a simple blood draw and a patient’s health record to produce an accurate picture of kidney health. A doctor can use KidneyIntelX results to act on patients at high risk of kidney disease progression or failure at an early stage where active management and therapeutics have the best opportunity to impact outcomes and cost before it is too late.

We have crossed key data, reimbursement and regulatory hurdles during a relatively short time-period since we began operations in 2018 through a public listing on AIM, a market of the London Stock Exchange. We subsequently expanded our capital base by raising a further $17 million in July 2019, $85 million through a listing on the Nasdaq Global Market in July 2020, and $26.8 million through an equity and convertible note financing in April 2022. The commercial roll-out of our kidney health solution, KidneyIntelX, is underscored by:

A 10-year government-wide contract with the U.S. General Services Administration at $950 per test
Hiring of sales, medical science liaison, and customer service support for national coverage
Joint program with American Diabetes Association® to improve overall kidney health in patients with type 2 diabetes
The Centers for Medicare & Medicaid Services awarding a national price of $950 per test
33 state Medicaid program authorization contracts
Launch of myIntelX national provider access portal for on-line ordering of KidneyIntelX
Partnerships announced with the Mount Sinai Health System, University of Utah, Atrium Health, Wake Forest Baptist Health, Capital District Physicians’ Health Plan (CDPHP), St. Joseph's Health and Singing River Health System
New York State Department of Health approval
A distinct Common Procedural Terminology (CPT) Code for reimbursement granted by the American Medical Association
26 private payor coverage determinations
Multi-center, peer reviewed clinical studies validating the clinical effectiveness and utility dynamics of KidneyIntelX for identifying patients at high risk for rapid kidney disease progression and/or kidney failure in the earliest stages of kidney disease

About KidneyIntelX

Our novel platform, KidneyIntelX, uses a machine-learning enabled algorithm to process predictive blood biomarkers with key features from a patient’s health record to generate an early and accurate kidney health risk score. The score identifies those patients at the most risk for kidney disease progression and/or failure and further guides ongoing clinical decisions.

KidneyIntelX is initially indicated for use with adults who have diagnosed kidney disease and diabetes – diabetic kidney disease or DKD. Future KidneyIntelX products in development intend to expand the indicated uses to include broader chronic kidney disease, health equity strategies and kidney health monitoring through treatment. Diabetes is the leading cause of chronic kidney disease, accounting for more than 40% of new cases, and DKD patients are the highest contributors to emergency room dialysis. Unfortunately, many DKD patients are unaware that they either have kidney disease or that their disease has been progressing, often uncontrolled, for many years and now find themselves making difficult decisions about late-stage treatments. We believe this predicament is largely avoidable and have built the KidneyIntelX care model to ultimately provide the estimated 210,000 primary care physicians in the United States with a comprehensive suite of information and guidelines driven follow-on action.

KidneyIntelX was designed as an expandable platform which is able to add indicated uses and a monitoring capability, all within an FDA regulated framework. Potential expansion may include extending into additional populations of chronic kidney disease patients beyond those with diabetes, including patients of African ancestry with the APOL1 high-risk genotype. We also intend to develop solutions for use in other large chronic disease patient populations, like cardiovascular disease.

Operational Progress

Renalytix is pleased to report continued KidneyIntelX testing volume growth under a backdrop of increasing insurance coverage and new medical systems coming on-line. In our New York launch market, KidneyIntelX utilization has continued to accelerate through the end of March. We have now provided integrated advanced risk assessment services for over 3,000 patients with kidney disease and diabetes. In addition, over the past six months KidneyIntelX clinical testing has now been brought on-line within the Veterans Health Administration, our Albany New York physician led payor partner, Atrium Health and Wake Forest Baptist Health in the Southeast. We estimate our current serviceable patient population with insurance payment availability for KidneyIntelX testing at greater than one million patients.

Our commercial focus in calendar year 2022 remains on regions where our health system partnerships provide a base for adoption of KidneyIntelX testing. As of the end of March 2022, we have four regional sales managers and 12 account executives focused on the Veterans Health Administration. We have also added a regional manager and three sales executives focused on the New York market. This sales effort is being complemented by a medical education effort led by a team of seven medical liaisons and our partnership with the National Kidney Foundation to offer chronic kidney disease education nationally. We expect additional health providers to be brought on-line in the next few months, including recently announced St. Josephs Health in central New York State, and now expect to exceed 20 health centers running KidneyIntelX patient risk assessment in calendar 2022.

Reimbursement and Regulatory

Insurance payment remains the biggest factor to driving KidneyIntelX adoption and revenue growth. Over the past year, we have consistently demonstrated that we can secure payment for KidneyIntelX from a diverse set of insurance sources. To date, we have received 26 private insurance coverage contracts, and contracted with 33 state Medicaid programs. Our $950 reportable pricing structure has been established by National Medicare and a 10-year government contract covering, among others, payment for patient testing in the Veterans Health Administration Medical system.

Under our real-world evidence study program with Mount Sinai Health System, several metrics are pointing to greater efficiencies being achieved with KidneyIntelX physician onboarding, including the fact that time to first KidneyIntelX order from education/training has dropped to three days currently from eleven days in our fiscal second quarter.

Our partnership model with Mount Sinai Health System under our real-world evidence study program is validating the engagement of population health departments and KidneyIntelX electronic health record integration to improving primary care physician access to advanced prognosis in kidney disease. The advantages of an integrated KidneyIntelX solution in a large hospital system include 1) broad physician education and care pathway support, 2) electronic test ordering and reporting, 3) advanced data analytics and 4) patient education and support.

Our laboratory testing infrastructure and personnel include the capacity to scale efficiently as distribution opportunities expand in fiscal 2022 and 2023. We have now achieved CAP Accreditation and ISO Certification for both Salt Lake City and New York City laboratories, all important parts to expand testing services and qualify for certain reimbursement.

Continuing to build a robust peer-reviewed published data pool is a compelling driver for payer and market adoption. In January, data was published in American Journal of Nephrology demonstrating the value of KidneyIntelX for monitoring patient response to new drug therapy in 1,325 multinational clinical trial cohort patients. And in February, at the World Congress of Nephrology, we provided results demonstrating KidneyIntelX provides robust prognostic information to better predict the future rate of decline in kidney function compared with current standard diagnostics in patients with early-stage chronic kidney disease and type 2 diabetes.


Current trading and outlook

We reported testing revenues of $0.8 million in our fiscal third quarter, compared to $0.7 million in Q2 and $0.5 million in Q1. Volumes with Mount Sinai continued to increase in Q3 and, while the first half of Q4 saw an initial reduction in these due to temporary changes in procedures and automation systems at Mount Sinai, the second half of Q4 has seen a return to Q3 levels. We anticipate that continued increasing Mount Sinai volumes, coupled with additional hospital systems coming on-line in fiscal 2023, will result in corresponding increases in testing volumes. Based on information available as of today, we anticipate Renalytix’s revenue for the 2022 fiscal year ending June 30, 2022 to be approximately $2.9 million (of which $2.7 million is testing revenue), up from $1.5 million in FY 2021, of which $0.4 million was testing revenue.

In the fiscal second quarter, we made a number of one-time investments pertaining to the recruiting, equipping, training and deploying of our salesforce, and associated marketing and other expenses to enable them to be most successful in the field. We are pleased with the sales infrastructure we now have in place to pursue the large Veterans Health Administration and commercial hospital opportunities that are available to us. As we grow the business, we plan to exercise continued prudent cash discipline.

FINANCIAL REVIEW

Financial review of the three-month period ended March 31, 2022 and comparison to prior year period

Our operating loss for the three months ended March 31, 2022, was $14.5 million (March 31, 2021: $8.1 million) and the net loss attributable to ordinary shareholders for the three months ended March 31, 2022, was $14.7 million (March 31, 2021: $8.8 million).

Revenue

During the three months ended March 31, 2022, we recognized $0.8 million of revenue related to KidneyIntelX testing. There was $0.1 million of revenue related to KidneyIntelX testing and $0.6 million of professional services revenue for the three months ended March 31, 2021.

Cost of Revenue

During the three months ended March 31, 2022, cost of revenue consisted of $0.7 million primarily attributable to KidneyIntelX testing, including labor and materials costs directly related to revenue generating activities. There was $0.2 million of cost of revenue for the three months ended March 31, 2021.

Research and Development Costs

Research and development expenses increased by $0.8 million, from $3.1 million for the three months ended March 31, 2021 to $3.9 million for the three months ended March 31, 2022. The increase was driven by employee related expenses, lab supplies and professional fees associated with the utility studies at Mount Sinai, Wake Forest and University of Utah.

General and Administrative Costs

General and administrative expenses increased by $5.3 million, from $5.5 million for the three months ended March 31, 2021 to $10.8 million for the three months ended March 31, 2022. The increase was primarily due to a $4.3 million increase in compensation, reimbursable expenses and related benefits, including share-based payments, due to increased headcount, a $0.7 million increase in consulting and professional fees including marketing expense, a $0.2 million increase in computers, software and IT costs, and a $0.1 million increase in other operating expenses.

Performance of Contract Liability to Affiliate

In May 2020, we and the Icahn School of Medicine at Mount Sinai entered into an operating agreement to form a joint venture, Kantaro Biosciences LLC, or Kantaro, for the purpose of developing and commercializing laboratory tests for the detection of antibodies against SARS-CoV-2 originally developed by Mount Sinai. During the three months ended March 31, 2022, we recognized $0.03 million of expense related to the performance of our contract liability with Kantaro compared to $0.1 million during the three months ended March 31, 2021. This represents the allocation of costs related to performing services on behalf of Kantaro.

Foreign Currency Loss

During the three months ended March 31, 2022, we recorded an unrealized foreign exchange gain of $2.4 million primarily attributable to intercompany loans and cash balances denominated in currencies other than the functional currency. We recorded an unrealized foreign currency loss of $1.1 million during the three months ended March 31, 2021.

Fair Value Adjustments to VericiDx Investment

We account for our investment in VericiDx using the equity method of accounting and have elected to use the fair value option to value the investment. During the three months ended March 31, 2022, we recorded a loss of $2.6 million to adjust the VericiDx investment to fair value. We recorded a gain of $0.3 million during the three months ended March 31, 2021.


Financial review of the nine months ended March 31, 2022 and comparison to prior year period

Our operating loss for the nine months ended March 31, 2022, was $40.1 million (March 31, 2021: $22.1 million) and the net loss attributable to ordinary shareholders for the nine months ended March 31, 2022, was $40.1 million (March 31, 2021: $24.9 million).

Revenue

During the nine months ended March 31, 2022, we recognized $1.9 million of revenue related to KidneyIntelX and $0.2 million of revenue related to services performed for AstraZeneca. During the nine months ended March 31, 2021, we recognized $0.4 million of pharmaceutical services revenue related to the statement of work with AstraZeneca, $0.6 million of services revenue related to work performed for Mount Sinai and $0.1 million of KidneyIntelX testing revenue.

Cost of Revenue

During the nine months ended March 31, 2022, cost of revenue consisted of $1.4 million primarily attributable to KidneyIntelX testing, including labor and materials costs directly related to revenue generating activities. There was $0.4 million of cost of revenue for the nine months ended March 31, 2021.

Research and Development Costs

Research and development expenses increased by $4.7 million, from $7.3 million for the nine months ended March 31, 2021 to $12.0 million for the nine months ended March 31, 2022. The increased R&D expense was driven by employee related expenses and professional fees associated with the utility studies at Mount Sinai, Wake Forest and University of Utah.

General and Administrative Costs

General and administrative expenses increased by $12.7 million, from $16.3 million for the nine months ended March 31, 2021 to $29.0 million for the nine months ended March 31, 2022. The increase was primarily due to a $8.7 million increase in compensation, reimbursable expenses and related benefits, including share-based payments, due to increased headcount, a $2.7 million increase in consulting and professional fees including marketing expense, a $1.0 million increase in computers, software and IT costs and a $0.3 million increase in other operating expenses.

Performance of Contract Liability to Affiliate

In May 2020, we and the Icahn School of Medicine at Mount Sinai entered into an operating agreement to form a joint venture, Kantaro Biosciences LLC, or Kantaro, for the purpose of developing and commercializing laboratory tests for the detection of antibodies against SARS-CoV-2 originally developed by Mount Sinai. During the nine months ended March 31, 2022, we recognized $0.2 million of expense related to the performance of our contract liability with Kantaro compared to $0.9 million during the nine months ended March 31, 2021. This represents the allocation of costs related to performing services on behalf of Kantaro.

Foreign Currency Gain (Loss)

During the nine months ended March 31, 2022, we recorded an unrealized foreign exchange gain of $4.6 million primarily attributable to intercompany loans and cash balances denominated in currencies other than the functional currency. We recorded an unrealized foreign currency loss of $8.8 million during the nine months ended March 31, 2021.

Fair Value Adjustments to VericiDx Investment

We account for our investment in VericiDx using the equity method of accounting and have elected to use the fair value option to value the investment. During the nine months ended March 31, 2022, we recorded a loss of $4.6 million to adjust the VericiDx investment to fair value. We recorded a gain of $5.4 million during the nine months ended March 31, 2021.

Liquidity and Capital Resources

Since our inception, we have incurred net losses. As of March 31, 2022, we had an accumulated deficit of $127.6 million.

We expect to incur additional losses in the near future, and we expect our expenses to increase in connection with our ongoing activities, particularly as we continue to commercialize and scale KidneyIntelX, particularly as we conduct our ongoing and planned clinical utility and other studies for KidneyIntelX for its commercial launch, develop and refine our artificial intelligence technology platform, seek regulatory clearances or approvals for KidneyIntelX or any other product we develop, establish and maintain partnerships with healthcare systems, pursue our coverage and reimbursement strategy and continue to invest in our infrastructure to support our manufacturing and other activities. In addition, we expect to incur additional costs associated with operating as a public company in the United States. The timing and amount of our operating expenditures will depend largely on:

the cost, progress and results of our ongoing and planned validation studies and health economic studies;
the cost, timing and outcome of entering into and maintaining partnership agreements with healthcare systems for the commercial sale of KidneyIntelX;
the cost of manufacturing clinical and commercial supply of KidneyIntelX;

the cost, timing and outcome of regulatory review of KidneyIntelX, including any post-marketing studies that could be required by regulatory authorities;
the cost, timing and outcome of identified and potential future commercialization activities, including manufacturing, marketing, sales and distribution, for KidneyIntelX;
the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims, including any claims by third parties that we are infringing upon their intellectual property rights;
the timing and amount of future revenue, if any, received from commercial sales of KidneyIntelX;
the sales price and availability of adequate third-party coverage and reimbursement for KidneyIntelX;
the effect of competing technological and market developments; and
the extent to which we acquire or invest in businesses, products and technologies, such as Kantaro, although we currently have no other commitments or agreements to complete any such transactions.

To date, we have primarily financed our operations through equity and debt financings. As of March 31, 2022, we had cash and cash equivalents of $32.4 million. We believe that our pre-financing cash balance together with the aggregate $26.8 million of gross proceeds raised in April 2022 will enable us to fund our current operating plan for at least the next 12 months. We have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect.

Until such time, if ever, as we can generate substantial revenue from sales of KidneyIntelX tests, we expect to finance our cash needs through a combination of securities offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements with third parties. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our shareholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our shareholders. Historically, we have not obtained traditional bank debt financing. EKF provided short-term debt financing that was repaid in November 2018 and we received a loan in an aggregate principal amount of $255,000 pursuant to the Paycheck Protection Program (the “PPP”) under the Coronavirus Aid, Relief, and Economic Security (CARES) Act and implemented by the U.S. Small Business Administration. In April 2022, we announced that we had closed a fundraising transaction comprising (1) an $8.8 million equity subscription at $7.25 per ADS ($3.625 per ordinary share) and (2) a $21.2 million aggregate principal amount of convertible bonds with an issue price of 85 per cent of the principal amount (resulting in net cash proceeds of $18.02 million), 5.5% coupon (payable in cash or shares at the Company’s option) and a 5-year term. This transaction is further described in our Report on Form 6-K filed on April 1, 2022. See Note 13 to our financial statements found elsewhere in this report.

Cash Flows

Net cash used in operating activities

During the nine months ended March 31, 2022, net cash used in operating activities was $31.8 million and was primarily attributable to our $40.1 million net loss including a $4.7 million net change in our operating assets and liabilities and $3.7 million in noncash charges. The change in our operating assets and liabilities was primarily attributable to a $7.0 million increase in accrued expenses and other current liabilities, driven by a $4.0 million current liability related to funds received from the Icahn School of Medicine at Mount Sinai ahead of the April equity investment, offset by a $2.9 million decrease in prepaid expenses and other current assets. Noncash charges were primarily related to $2.9 million in share-based compensation and the $4.6 million fair value adjustment of our Verici securities, offset by a $4.2 million unrealized foreign exchange gain.

During the nine months ended March 31, 2021, we used $23.3 million of cash in operating activities primarily attributable to our net loss of $25.5 million. This use of cash was partially offset by $2.2 million in noncash items such as depreciation and amortization, share-based compensation, equity losses in Kantaro, change in fair value of our VericiDx investment and foreign exchange remeasurement losses. The net cash outflow from changes in our operating assets and liabilities remained relatively unchanged.

Net cash used in investing activities

During the nine months ended March 31, 2022, net cash used in investing activities was $0.7 million, primarily attributable to $0.6 million for purchases of lab and office equipment and $0.1 million in software development costs.

During the nine months ended March 31, 2021, net cash used in investing activities was $0.5 million and primarily attributable to $1.0 million in proceeds from short-term investments. This was offset by $0.9 million for the purchase of lab and office equipment, $0.4 million of software development costs and an increase of $0.2 million related to our note receivable from a related party. In addition, cash decreased by $0.06 million due to the deconsolidation of VericiDx.

Net cash used in financing activities

During the nine months ended March 31, 2022, net cash provided by financing activities was $0.3 million and was primarily attributable to $0.1 million in proceeds from the issuance of ordinary shares under our employee stock purchase program as well as $0.2 million in proceeds from the exercise of stock options.


During the nine months ended March 31, 2021, net cash provided by financing activities was $76.9 million and was primarily attributable to $79.2 million of proceeds from our IPO on the Nasdaq Global Market which was partially offset by offering costs of $2.3 million associated with the IPO that were paid in the period.

Cash and Cash Equivalents

We had cash and cash equivalents of $32.4 million as of March 31, 2022, which decreased from $65.2 million as of June 30, 2021 due to normal operations as we continue to commercialize KidneyIntelX and grow our business. This was prior to the completion of the $26.8 million (gross) financing package, further details of which were announced on March 31, 2022, which completed post-period end on April 8, 2022.

Critical accounting policies and significant judgments and estimates

Our management's discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which we have prepared in accordance with generally accepted accounting principles in the United States, "U.S. GAAP". The preparation of our unaudited condensed consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our unaudited condensed consolidated financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.

There have been no material changes to our critical accounting policies from those described in "Management's Discussion and Analysis of Financial Condition and Results of Operations" included in our Annual Report.

Recent accounting pronouncements

See Note 3 to our financial statements found elsewhere in this report for a description of recent accounting pronouncements applicable to our financial statements.

JOBS Act transition period

In April 2012, the JOBS Act was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended, for complying with new or revised accounting standards. An emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to take advantage of the extended transition period for complying with new or revised accounting standards and, as a result, our financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates. We are in the process of evaluating the benefits of relying on other exemptions and reduced reporting requirements under the JOBS Act. Subject to certain conditions, as an emerging growth company, we may rely on certain of these exemptions, including without limitation exemptions to the requirements for (1) providing an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (2) complying with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We will remain an emerging growth company until the earlier to occur of (a) the last day of the fiscal year (1) following the fifth anniversary of the completion of our U.S. IPO, (2) in which we have total annual gross revenues of at least $1.07 billion or (3) in which we are deemed to be a “large accelerated filer” under the rules of the SEC, which means the market value of our ordinary shares and ADSs that are held by non-affiliates exceeds $700.0 million as of the prior December 31, or (b) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.


 


Renalytix plc

Condensed Consolidated balance sheets (Unaudited)

(in thousands, except share and per share data)

 

March 31, 2022

 

 

June 30, 2021

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

32,361

 

 

$

65,128

 

Accounts receivable

 

 

1,009

 

 

 

594

 

Prepaid expenses and other current assets

 

 

3,837

 

 

 

993

 

Note receivable from Kantaro

 

 

75

 

 

 

75

 

Receivable from affiliates

 

 

1

 

 

 

1

 

Total current assets

 

 

37,283

 

 

 

66,791

 

Property and equipment, net

 

 

2,850

 

 

 

2,490

 

Investment in VericiDx

 

 

4,322

 

 

 

9,295

 

Investment in Kantaro

 

 

11

 

 

 

Total assets

 

$

44,466

 

 

$

78,576

 

 

 

 

 

 

 

 

Liabilities and Shareholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

2,056

 

 

$

1,403

 

Accounts payable – related party

 

 

1,007

 

 

 

361

 

Accrued expenses and other current liabilities

 

 

6,689

 

 

 

4,602

 

Accrued expenses – related party

 

 

5,031

 

 

 

224

 

Deferred revenue

 

 

67

 

 

 

122

 

Payable to affiliate – current

 

 

187

 

 

 

350

 

Total current liabilities

 

 

15,037

 

 

 

7,062

 

Other liabilities

 

 

14

 

 

 

53

 

Total liabilities

 

 

15,051

 

 

 

7,115

 

 

 

 

 

 

 

 

Commitments and contingencies (Note 8)

 

 

 

 

 

 

 

 

 

 

 

 

 

Shareholders’ equity:

 

 

 

 

 

 

Ordinary shares, £0.0025 par value per share: 76,869,831 shares
   authorized;
72,308,930 and 72,197,286 shares issued and
   outstanding at March 31, 2022 and June 30, 2021, respectively

 

 

220

 

 

 

220

 

Additional paid-in capital

 

 

153,604

 

 

 

150,407

 

Accumulated other comprehensive income

 

 

3,156

 

 

 

8,276

 

Accumulated deficit

 

 

(127,565

)

 

 

(87,442

)

Total shareholders’ equity

 

 

29,415

 

 

 

71,461

 

Total liabilities and shareholders’ equity

 

$

44,466

 

 

$

78,576

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.


Renalytix plc

Condensed Consolidated statements of operations and comprehensive loss (Unaudited)

 

 

Three Months Ended

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

Nine Months Ended

 

(in thousands, except share data)

 

March 31, 2022

 

 

March 31, 2021

 

 

March 31, 2022

 

 

March 31, 2021

 

Revenue

 

$

812

 

 

$

619

 

 

$

2,139

 

 

$

1,019

 

Cost of revenue

 

 

685

 

 

 

169

 

 

 

1,404

 

 

 

426

 

Gross profit

 

 

127

 

 

 

450

 

 

 

735

 

 

 

593

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

3,887

 

 

 

3,104

 

 

 

12,019

 

 

 

7,311

 

General and administrative

 

 

10,809

 

 

 

5,547

 

 

 

29,012

 

 

 

16,258

 

Performance of contract liability to affiliate

 

 

(32

)

 

 

(130

)

 

 

(163

)

 

 

(889

)

Total operating expenses

 

 

14,664

 

 

 

8,521

 

 

 

40,868

 

 

 

22,680

 

Loss from operations

 

 

(14,537

)

 

 

(8,071

)

 

 

(40,133

)

 

 

(22,087

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Equity in net (losses) earnings of affiliate

 

 

(26

)

 

 

(8

)

 

 

11

 

 

 

(229

)

Foreign currency gain (loss), net

 

 

2,447

 

 

 

(1,095

)

 

 

4,587

 

 

 

(8,783

)

Fair value adjustment to VericiDx investment

 

 

(2,575

)

 

 

337

 

 

 

(4,596

)

 

 

5,355

 

Other (expense) income, net

 

 

(4

)

 

 

61

 

 

 

8

 

 

 

228

 

Net loss

 

 

(14,695

)

 

 

(8,776

)

 

 

(40,123

)

 

 

(25,516

)

Net loss attributable to noncontrolling interest

 

 

 

 

 

 

 

 

 

 

 

(611

)

Net loss attributable to ordinary shareholders

 

 

(14,695

)

 

 

(8,776

)

 

 

(40,123

)

 

 

(24,905

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

Foreign exchange translation adjustment

 

 

(2,632

)

 

 

1,163

 

 

 

(5,120

)

 

 

9,504

 

Comprehensive loss

 

 

(17,327

)

 

 

(7,613

)

 

 

(45,243

)

 

 

(16,012

)

Comprehensive loss attributable to noncontrolling
   interest

 

 

 

 

 

 

 

 

 

 

 

(72

)

Comprehensive loss attributable to Renalytix

 

$

(17,327

)

 

$

(7,613

)

 

$

(45,243

)

 

$

(15,940

)

Net loss per ordinary share—basic and diluted

 

$

(0.20

)

 

$

(0.12

)

 

$

(0.56

)

 

$

(0.35

)

Weighted average ordinary shares—basic and
   diluted

 

 

72,297,309

 

 

 

72,035,126

 

 

 

72,274,979

 

 

 

71,294,883

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.


Renalytix plc

Condensed Consolidated statements of shareholders’ equity (Unaudited)

 

 

Ordinary shares

 

 

Additional
paid-in

 

 

Accumulated
other
comprehensive

 

 

Accumulated

 

 

Total
shareholders’

 

(in thousands, except share and per share data)

 

Shares

 

 

Amount

 

 

capital

 

 

income (loss)

 

 

deficit

 

 

equity

 

Balance at July 1, 2021

 

 

72,197,286

 

 

$

220

 

 

$

150,407

 

 

$

8,276

 

 

$

(87,442

)

 

$

71,461

 

Shares issued under the employee share
   purchase plan

 

 

10,920

 

 

 

 

 

 

120

 

 

 

 

 

 

 

 

 

120

 

Exercise of stock options

 

 

32,500

 

 

 

 

 

 

86

 

 

 

 

 

 

 

 

 

86

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

997

 

 

 

 

 

 

 

 

 

997

 

Currency translation adjustments

 

 

 

 

 

 

 

 

 

 

 

(2,585

)

 

 

 

 

 

(2,585

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(10,106

)

 

 

(10,106

)

Balance at September 30, 2021

 

 

72,240,706

 

 

$

220

 

 

$

151,610

 

 

$

5,691

 

 

$

(97,548

)

 

$

59,973

 

Exercise of stock options

 

 

68,224

 

 

 

 

 

 

111

 

 

 

 

 

 

 

 

 

111

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

941

 

 

 

 

 

 

 

 

 

941

 

Currency translation adjustments

 

 

 

 

 

 

 

 

 

 

 

97

 

 

 

 

 

 

97

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(15,322

)

 

 

(15,322

)

Balance at December 31, 2021

 

 

72,308,930

 

 

$

220

 

 

$

152,662

 

 

$

5,788

 

 

$

(112,870

)

 

$

45,800

 

Exercise of stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

942

 

 

 

 

 

 

 

 

 

942

 

Currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

(2,632

)

 

 

 

 

 

(2,632

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(14,695

)

 

 

(14,695

)

Balance at March 31, 2022

 

 

72,308,930

 

 

$

220

 

 

$

153,604

 

 

$

3,156

 

 

$

(127,565

)

 

$

29,415

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 


Renalytix plc

Condensed Consolidated statements of shareholders’ equity (Unaudited)

 

 

Ordinary shares

 

 

Additional
paid-in

 

 

Accumulated other comprehensive

 

 

Accumulated

 

 

Total
shareholders’
(deficit) equity
attributable to

 

 

Noncontrolling

 

 

Total
shareholders’

 

(in thousands, except share and per share data)

 

Shares

 

 

Amount

 

 

capital

 

 

income (loss)

 

 

deficit

 

 

Renalytix

 

 

interests

 

 

equity

 

Balance at July 1, 2020

 

 

59,416,134

 

 

$

179

 

 

$

69,650

 

 

$

(1,200

)

 

$

(52,717

)

 

$

15,912

 

 

$

 

 

$

15,912

 

Sale of ordinary shares in initial public offering on Nasdaq, net of offering costs and underwriting fees of $9,007

 

 

12,613,500

 

 

 

40

 

 

 

76,094

 

 

 

 

 

 

 

 

 

76,134

 

 

 

 

 

 

76,134

 

VericiDx distribution in specie

 

 

 

 

 

 

 

1,638

 

 

 

(25

)

 

 

 

 

 

1,613

 

 

 

(1,613

)

 

 

 

Share-based compensation expense

 

 

 

 

 

 

 

501

 

 

 

 

 

 

 

 

 

501

 

 

 

 

 

 

501

 

Currency translation adjustments

 

 

 

 

 

 

 

 

 

 

2,255

 

 

 

 

 

 

2,255

 

 

 

(67

)

 

 

2,188

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

(7,221

)

 

 

(7,221

)

 

 

(393

)

 

 

(7,614

)

Balance at September 30, 2020

 

 

72,029,634

 

 

$

219

 

 

$

147,883

 

 

$

1,030

 

 

$

(59,938

)

 

$

89,194

 

 

$

(2,073

)

 

$

87,121

 

VericiDx noncontrolling interest upon
   deconsolidation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,296

 

 

 

2,296

 

Share-based compensation expense

 

 

 

 

 

 

 

525

 

 

 

 

 

 

 

 

 

525

 

 

 

 

 

 

525

 

Currency translation adjustments

 

 

 

 

 

 

 

 

 

 

6,086

 

 

 

 

 

 

6,086

 

 

 

(5

)

 

 

6,081

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

(8,908

)

 

 

(8,908

)

 

 

(218

)

 

 

(9,126

)

Balance at December 31, 2020