10-Q
--12-31Q30001659352false0001659352us-gaap:FairValueInputsLevel3Member2022-09-300001659352us-gaap:RetainedEarningsMember2021-03-310001659352us-gaap:ResearchAndDevelopmentExpenseMember2022-07-012022-09-300001659352cdak:KaylaTherapeuticsSASMembercdak:KaylaLicenseAgreementMembersrt:MaximumMembercdak:PhaseOneOrTwoClinicalTrialMember2018-11-060001659352us-gaap:CommonStockMember2021-09-300001659352cdak:CollaborationMembercdak:SareptaTherapeuticsMember2021-07-012021-09-300001659352us-gaap:CommonStockMember2021-07-012021-09-300001659352cdak:SareptaResearchAgreementMember2022-01-012022-09-300001659352cdak:CollaborationMembercdak:SareptaTherapeuticsMember2022-01-012022-09-300001659352us-gaap:RetainedEarningsMember2021-01-012021-03-310001659352us-gaap:WarrantMember2022-07-012022-09-300001659352us-gaap:RetainedEarningsMember2022-09-300001659352us-gaap:RestrictedStockUnitsRSUMember2022-01-012022-09-300001659352cdak:JazzPharmaceuticalsIrelandLimitedMember2022-01-012022-09-300001659352cdak:TermLoanMembercdak:HerculesCapitalIncMembercdak:LoanAndSecurityAgreementMembercdak:FirstTrancheMember2020-07-242020-07-240001659352cdak:MDAndersonCancerCenterMembercdak:PatentAndTechnologyLicenseAgreementMember2021-09-300001659352us-gaap:AdditionalPaidInCapitalMember2022-06-3000016593522021-12-310001659352us-gaap:RetainedEarningsMember2021-04-012021-06-300001659352us-gaap:GrantMember2022-01-012022-09-300001659352cdak:TermLoanMembercdak:ThirdTrancheMembercdak:HerculesCapitalIncMembercdak:AmendedLoanAndSecurityAgreementMember2019-09-302019-09-300001659352cdak:FourHartwellPlaceMember2021-11-150001659352cdak:SareptaResearchAgreementMember2021-07-012021-09-300001659352cdak:MDAndersonCancerCenterMembercdak:PatentAndTechnologyLicenseAgreementMember2022-09-3000016593522022-08-012022-08-310001659352us-gaap:FairValueMeasuredAtNetAssetValuePerShareMemberus-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001659352us-gaap:CommonStockMember2022-06-300001659352cdak:LonzaRocklandIncorporationMembercdak:ManufacturingServicesAgreementMember2022-09-300001659352us-gaap:AdditionalPaidInCapitalMember2020-12-310001659352cdak:OneTimeTerminationBenefitsAndContractualTerminationBenefitsMember2022-01-012022-09-300001659352us-gaap:RetainedEarningsMember2021-07-012021-09-300001659352cdak:CollaborationMember2021-07-012021-09-300001659352us-gaap:AdditionalPaidInCapitalMembercdak:WarrantsMember2022-07-012022-09-300001659352us-gaap:ShareBasedPaymentArrangementNonemployeeMember2022-07-012022-09-300001659352cdak:ThirtyFiveCambridgeParkDriveMemberus-gaap:LetterOfCreditMember2022-09-300001659352cdak:AmendedLoanAndSecurityAgreementMember2022-09-300001659352cdak:TwoThousandTwentyStockOptionAndIncentivePlanMember2020-10-310001659352us-gaap:RetainedEarningsMember2022-01-012022-03-310001659352us-gaap:RetainedEarningsMember2021-09-300001659352us-gaap:CommonStockMember2021-12-310001659352cdak:TermLoanMembercdak:HerculesCapitalIncMembercdak:SecondTrancheMembercdak:AmendedLoanAndSecurityAgreementMember2019-09-302019-09-300001659352us-gaap:AdditionalPaidInCapitalMembercdak:AtTheMarketOfferingMember2022-01-012022-03-3100016593522022-04-012022-06-300001659352cdak:CollaborationMember2022-07-012022-09-300001659352us-gaap:ResearchAndDevelopmentExpenseMember2021-07-012021-09-300001659352cdak:TwoThousandTwentyEmployeeStockPurchasePlanMember2022-09-300001659352us-gaap:GeneralAndAdministrativeExpenseMember2021-01-012021-09-3000016593522022-06-300001659352cdak:AtTheMarketOfferingMemberus-gaap:CommonStockMember2022-01-012022-03-310001659352us-gaap:RetainedEarningsMember2021-12-310001659352cdak:KaylaTherapeuticsSASMembercdak:KaylaLicenseAgreementMember2022-01-012022-09-300001659352us-gaap:RetainedEarningsMember2022-06-300001659352us-gaap:WarrantMember2022-01-012022-09-300001659352cdak:MDAndersonCancerCenterMembercdak:PatentAndTechnologyLicenseAgreementMember2022-01-012022-09-300001659352cdak:FourHartwellPlaceMember2019-03-052019-03-050001659352cdak:FourHartwellPlaceMember2022-01-012022-09-300001659352cdak:JazzPharmaceuticalsIrelandLimitedMembercdak:CollaborationAndLicenseAgreementMember2021-12-310001659352cdak:ThirtyFiveCambridgeParkDriveMember2021-07-012021-07-010001659352cdak:TherapeuticProductsMembersrt:MaximumMembercdak:MDAndersonCancerCenterMembercdak:PatentAndTechnologyLicenseAgreementMember2015-11-300001659352us-gaap:FairValueInputsLevel3Membercdak:MeasurementInputStrikePriceMember2022-09-300001659352us-gaap:RetainedEarningsMember2021-06-300001659352us-gaap:RestrictedStockUnitsRSUMember2022-09-3000016593522022-03-310001659352cdak:JazzPharmaceuticalsIrelandLimitedMembercdak:CollaborationAndLicenseAgreementMember2022-04-012022-06-300001659352cdak:JazzPharmaceuticalsIrelandLimitedMembercdak:CollaborationMember2021-01-012021-09-300001659352us-gaap:AdditionalPaidInCapitalMember2021-09-300001659352srt:MinimumMembercdak:MDAndersonCancerCenterMembercdak:PatentAndTechnologyLicenseAgreementMember2015-11-012021-02-010001659352cdak:TermLoanMembercdak:HerculesCapitalIncMembercdak:FirstTrancheMembercdak:AmendedLoanAndSecurityAgreementMember2019-09-302019-09-300001659352us-gaap:CommonStockMemberus-gaap:IPOMember2021-01-012021-03-310001659352us-gaap:CommonStockMember2022-03-310001659352us-gaap:EmployeeStockOptionMember2021-07-012021-09-300001659352cdak:TermLoanMembercdak:HerculesCapitalIncMembercdak:LoanAndSecurityAgreementMember2019-09-300001659352cdak:LonzaRocklandIncorporationMember2021-11-150001659352us-gaap:FairValueMeasurementsRecurringMember2022-09-300001659352cdak:TwoThousandTwentyStockOptionAndIncentivePlanMember2022-09-300001659352us-gaap:AdditionalPaidInCapitalMember2021-12-310001659352cdak:TermLoanMembercdak:HerculesCapitalIncMembercdak:AmendedLoanAndSecurityAgreementMember2022-01-012022-09-3000016593522020-12-3100016593522022-01-012022-03-310001659352cdak:TermLoanMembercdak:HerculesCapitalIncMembercdak:LoanAndSecurityAgreementMembercdak:FirstTrancheMember2019-09-302019-09-300001659352us-gaap:MeasurementInputSharePriceMemberus-gaap:FairValueInputsLevel3Member2022-09-300001659352cdak:JazzPharmaceuticalsIrelandLimitedMembercdak:CollaborationAndLicenseAgreementMember2021-06-302021-06-300001659352us-gaap:AdditionalPaidInCapitalMembercdak:AtTheMarketOfferingMember2022-07-012022-09-300001659352cdak:HerculesCapitalIncMembercdak:AmendedTermLoanMembercdak:AmendedLoanAndSecurityAgreementMember2021-09-172021-09-170001659352cdak:ThirtyFiveCambridgeParkDriveMember2022-01-012022-09-300001659352us-gaap:CommonStockMember2020-12-310001659352cdak:TermLoanMembersrt:MaximumMembercdak:LoanAndSecurityAgreementMembercdak:HerculesCapitalIncMember2019-09-300001659352us-gaap:AdditionalPaidInCapitalMember2021-06-300001659352cdak:ThirtyFiveCambridgeParkDriveMemberus-gaap:OtherIncomeMember2022-07-012022-09-300001659352us-gaap:CommonStockMember2021-06-300001659352us-gaap:EmployeeStockOptionMember2022-07-012022-09-300001659352us-gaap:FairValueInputsLevel3Memberus-gaap:WarrantMemberus-gaap:FairValueMeasurementsRecurringMember2022-09-300001659352us-gaap:EmployeeStockOptionMember2022-01-012022-09-300001659352us-gaap:RetainedEarningsMember2022-04-012022-06-3000016593522021-02-170001659352cdak:TermLoanMembercdak:LoanAndSecurityAgreementMembercdak:HerculesCapitalIncMember2022-09-3000016593522022-10-270001659352cdak:CollaborationMembercdak:SareptaTherapeuticsMember2021-01-012021-09-300001659352us-gaap:AdditionalPaidInCapitalMember2021-07-012021-09-300001659352us-gaap:AdditionalPaidInCapitalMember2022-04-012022-06-300001659352us-gaap:CommonStockMember2021-04-012021-06-300001659352cdak:AtTheMarketOfferingMemberus-gaap:CommonStockMember2022-07-012022-09-300001659352srt:MaximumMembercdak:DiagnosticProductsMembercdak:MDAndersonCancerCenterMembercdak:PatentAndTechnologyLicenseAgreementMember2015-11-300001659352us-gaap:RestrictedStockUnitsRSUMember2022-07-012022-09-300001659352us-gaap:ShareBasedPaymentArrangementNonemployeeMember2021-01-012021-09-3000016593522021-02-172021-02-170001659352us-gaap:FairValueMeasuredAtNetAssetValuePerShareMemberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001659352cdak:TermLoanMembercdak:HerculesCapitalIncMembercdak:AmendedLoanAndSecurityAgreementMember2021-07-012021-09-300001659352us-gaap:IPOMember2021-01-012021-03-310001659352cdak:CoalitionForEpidemicPreparednessInnovationsMemberus-gaap:GrantMember2022-01-012022-09-300001659352us-gaap:LetterOfCreditMembercdak:FourHartwellPlaceMember2022-09-3000016593522021-01-012021-09-300001659352us-gaap:GeneralAndAdministrativeExpenseMember2022-01-012022-09-300001659352us-gaap:AdditionalPaidInCapitalMemberus-gaap:IPOMember2021-01-012021-03-310001659352us-gaap:CommonStockMembercdak:WarrantsMember2022-07-012022-09-300001659352cdak:FourHartwellPlaceMember2021-11-152021-11-150001659352cdak:OneTimeTerminationBenefitsAndContractualTerminationBenefitsMember2022-07-012022-09-300001659352cdak:AtTheMarketOfferingMember2022-01-012022-03-310001659352cdak:TermLoanMembercdak:HerculesCapitalIncMembercdak:LoanAndSecurityAgreementMembercdak:SecondTrancheMember2019-09-300001659352cdak:LonzaRocklandIncorporationMember2022-09-300001659352cdak:JazzPharmaceuticalsIrelandLimitedMembercdak:CollaborationMember2021-07-012021-09-300001659352us-gaap:ShareBasedPaymentArrangementNonemployeeMember2021-07-012021-09-300001659352cdak:ThirtyFiveCambridgeParkDriveMemberus-gaap:LetterOfCreditMember2020-04-270001659352cdak:FourHartwellPlaceMember2021-09-300001659352us-gaap:CommonStockMember2021-01-012021-03-310001659352cdak:TermLoanMembercdak:HerculesCapitalIncMembercdak:AmendedLoanAndSecurityAgreementMember2022-07-012022-09-300001659352us-gaap:GrantMember2022-07-012022-09-300001659352cdak:SareptaTherapeuticsMember2022-01-012022-09-300001659352cdak:ThirtyFiveCambridgeParkDriveMember2020-04-270001659352us-gaap:MeasurementInputExpectedTermMemberus-gaap:FairValueInputsLevel3Member2022-09-300001659352cdak:JazzPharmaceuticalsIrelandLimitedMembercdak:CollaborationAndLicenseAgreementMember2021-07-012021-09-300001659352us-gaap:FairValueMeasurementsRecurringMember2021-12-310001659352cdak:JazzPharmaceuticalsIrelandLimitedMembercdak:CollaborationAndLicenseAgreementMember2022-01-012022-09-300001659352cdak:TermLoanMembercdak:HerculesCapitalIncMembercdak:LoanAndSecurityAgreementMember2019-09-302019-09-300001659352us-gaap:AdditionalPaidInCapitalMember2021-03-3100016593522022-09-300001659352cdak:TermLoanMembercdak:ThirdTrancheMembercdak:LoanAndSecurityAgreementMembercdak:HerculesCapitalIncMember2019-09-300001659352cdak:JazzPharmaceuticalsIrelandLimitedMembercdak:CollaborationMember2022-07-012022-09-300001659352us-gaap:WarrantMemberus-gaap:FairValueMeasurementsRecurringMember2022-09-300001659352cdak:JazzPharmaceuticalsIrelandLimitedMembercdak:CollaborationAndLicenseAgreementMember2022-07-012022-09-300001659352cdak:HerculesCapitalIncMembercdak:AmendedTermLoanMembercdak:AmendedLoanAndSecurityAgreementMember2021-09-170001659352cdak:JazzPharmaceuticalsIrelandLimitedMembercdak:CollaborationAndLicenseAgreementMember2019-01-022019-01-0200016593522021-01-012021-03-310001659352cdak:HerculesCapitalIncMembercdak:AmendedTermLoanMembercdak:AmendedLoanAndSecurityAgreementMember2022-01-012022-09-300001659352cdak:FourHartwellPlaceMember2019-03-050001659352cdak:KaylaTherapeuticsSASMembercdak:KaylaLicenseAgreementMembercdak:PhaseOneOrTwoClinicalTrialMember2018-11-060001659352us-gaap:AdditionalPaidInCapitalMember2022-01-012022-03-3100016593522021-07-012021-09-300001659352cdak:HerculesCapitalIncMembercdak:AmendedTermLoanMembercdak:FourthTrancheMembercdak:AmendedLoanAndSecurityAgreementMember2021-09-170001659352us-gaap:GeneralAndAdministrativeExpenseMember2022-07-012022-09-300001659352us-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001659352cdak:AtTheMarketOfferingMember2022-07-012022-09-300001659352cdak:LonzaRocklandIncorporationMembercdak:ManufacturingServicesAgreementMember2022-01-012022-09-300001659352cdak:TermLoanMembercdak:HerculesCapitalIncMembercdak:AmendedLoanAndSecurityAgreementMember2021-01-012021-09-300001659352us-gaap:ShareBasedPaymentArrangementEmployeeMember2021-07-012021-09-300001659352srt:MaximumMembercdak:TwoThousandTwentyStockOptionAndIncentivePlanMember2020-10-310001659352cdak:JazzPharmaceuticalsIrelandLimitedMembercdak:CollaborationAndLicenseAgreementMember2022-09-300001659352srt:MaximumMembercdak:MDAndersonCancerCenterMembercdak:PatentAndTechnologyLicenseAgreementMember2015-11-3000016593522021-06-300001659352cdak:CoalitionForEpidemicPreparednessInnovationsMember2022-09-300001659352cdak:CoalitionForEpidemicPreparednessInnovationsMember2022-07-010001659352cdak:AtTheMarketOfferingMember2022-01-012022-09-300001659352us-gaap:GeneralAndAdministrativeExpenseMember2021-07-012021-09-300001659352cdak:MeasurementInputCommonStockVolatilityMemberus-gaap:FairValueInputsLevel3Member2022-09-300001659352us-gaap:RetainedEarningsMember2022-07-012022-09-3000016593522022-01-012022-09-300001659352cdak:KaylaTherapeuticsSASMembercdak:KaylaLicenseAgreementMember2022-09-300001659352us-gaap:RetainedEarningsMember2022-03-310001659352cdak:TwoThousandTwentyStockOptionAndIncentivePlanMember2022-01-010001659352cdak:TermLoanMembercdak:LoanAndSecurityAgreementMembercdak:HerculesCapitalIncMember2021-09-1600016593522020-10-162020-10-160001659352us-gaap:RetainedEarningsMember2020-12-310001659352us-gaap:ShareBasedPaymentArrangementEmployeeMember2021-01-012021-09-300001659352us-gaap:EmployeeStockOptionMember2021-01-012021-09-300001659352cdak:JazzPharmaceuticalsIrelandLimitedMembercdak:CollaborationMember2022-01-012022-09-300001659352cdak:WarrantsMember2022-07-012022-09-3000016593522022-09-152022-09-150001659352us-gaap:CommonStockMember2022-04-012022-06-300001659352us-gaap:FairValueInputsLevel3Member2022-01-012022-09-300001659352cdak:SareptaResearchAgreementMember2021-12-032021-12-030001659352us-gaap:ShareBasedPaymentArrangementEmployeeMember2022-01-012022-09-300001659352cdak:KaylaTherapeuticsSASMembercdak:KaylaLicenseAgreementMembercdak:PhaseOneOrTwoClinicalTrialMember2022-01-012022-09-300001659352us-gaap:AdditionalPaidInCapitalMember2022-03-310001659352cdak:SareptaResearchAgreementMember2021-10-012021-10-010001659352us-gaap:AdditionalPaidInCapitalMember2021-01-012021-03-310001659352cdak:KaylaTherapeuticsSASMembercdak:KaylaLicenseAgreementMembercdak:PhaseOneOrTwoClinicalTrialMember2020-01-012020-12-310001659352us-gaap:MeasurementInputRiskFreeInterestRateMemberus-gaap:FairValueInputsLevel3Member2022-09-300001659352cdak:CollaborationMember2021-01-012021-09-300001659352us-gaap:ResearchAndDevelopmentExpenseMember2021-01-012021-09-300001659352us-gaap:ShareBasedPaymentArrangementNonemployeeMember2022-01-012022-09-300001659352cdak:LonzaRocklandIncorporationMembercdak:ManufacturingServicesAgreementMember2021-11-152021-11-150001659352us-gaap:LetterOfCreditMembercdak:FourHartwellPlaceMember2021-12-310001659352cdak:TermLoanMembercdak:HerculesCapitalIncMembercdak:LoanAndSecurityAgreementMember2020-07-240001659352cdak:TermLoanMembercdak:HerculesCapitalIncMembercdak:LoanAndSecurityAgreementMembercdak:FourthTrancheMember2019-09-300001659352us-gaap:CommonStockMember2022-07-012022-09-300001659352us-gaap:CommonStockMember2021-03-310001659352us-gaap:RestrictedStockUnitsRSUMember2022-01-012022-09-3000016593522020-10-3100016593522020-10-160001659352cdak:KaylaTherapeuticsSASMembercdak:KaylaLicenseAgreementMembercdak:PhaseOneOrTwoClinicalTrialMember2018-11-062018-11-060001659352us-gaap:AdditionalPaidInCapitalMember2022-09-300001659352us-gaap:ShareBasedPaymentArrangementEmployeeMember2022-07-012022-09-300001659352cdak:AssetPurchaseAgreementMembercdak:LonzaRocklandIncorporationMember2021-11-150001659352cdak:CollaborationMember2022-01-012022-09-300001659352cdak:LicenseAndCollaborationAgreementMembercdak:LonzaRocklandIncorporationMember2022-01-012022-09-300001659352srt:MaximumMembercdak:HerculesCapitalIncMembercdak:FifthTrancheMembercdak:AmendedTermLoanMembercdak:AmendedLoanAndSecurityAgreementMember2021-09-170001659352us-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMember2022-09-300001659352cdak:JazzPharmaceuticalsIrelandLimitedMembercdak:CollaborationAndLicenseAgreementMember2021-01-012021-09-3000016593522021-03-3100016593522021-04-012021-06-300001659352cdak:ThirtyFiveCambridgeParkDriveMember2020-04-272020-04-270001659352cdak:ThirtyFiveCambridgeParkDriveMember2022-09-300001659352cdak:ThirtyFiveCambridgeParkDriveMemberus-gaap:LetterOfCreditMember2021-12-310001659352cdak:SareptaResearchAgreementMember2021-01-012021-09-300001659352cdak:SareptaResearchAgreementMember2022-01-012022-09-300001659352cdak:ThirtyFiveCambridgeParkDriveMember2019-03-220001659352cdak:TermLoanMembercdak:HerculesCapitalIncMembercdak:AmendedLoanAndSecurityAgreementMember2019-09-302019-09-300001659352cdak:SubleaseAgreementMembercdak:LonzaRocklandIncorporationMember2021-11-152021-11-150001659352us-gaap:ResearchAndDevelopmentExpenseMember2022-01-012022-09-300001659352cdak:JazzPharmaceuticalsIrelandLimitedMembercdak:CollaborationAndLicenseAgreementMember2022-03-310001659352cdak:ThirdTrancheMembercdak:HerculesCapitalIncMembercdak:AmendedTermLoanMembercdak:AmendedLoanAndSecurityAgreementMember2021-09-170001659352us-gaap:AdditionalPaidInCapitalMember2022-07-012022-09-300001659352cdak:ThirtyFiveCambridgeParkDriveMember2019-03-222019-03-220001659352cdak:JazzPharmaceuticalsIrelandLimitedMembercdak:CollaborationAndLicenseAgreementMember2021-04-012021-04-300001659352cdak:HerculesCapitalIncMembercdak:FifthTrancheMembercdak:AmendedTermLoanMembercdak:AmendedLoanAndSecurityAgreementMember2021-09-170001659352cdak:CoalitionForEpidemicPreparednessInnovationsMemberus-gaap:GrantMember2022-07-012022-09-300001659352us-gaap:AdditionalPaidInCapitalMember2021-04-012021-06-3000016593522021-09-300001659352us-gaap:PrimeRateMembercdak:HerculesCapitalIncMembercdak:AmendedTermLoanMembercdak:AmendedLoanAndSecurityAgreementMember2021-09-172021-09-170001659352cdak:TermLoanMembercdak:HerculesCapitalIncMembercdak:LoanAndSecurityAgreementMember2021-12-3100016593522022-07-012022-09-300001659352cdak:ThirtyFiveCambridgeParkDriveMember2021-07-0100016593522021-01-012021-12-310001659352us-gaap:CommonStockMember2022-09-3000016593522022-09-15cdak:Targetcdak:Officeiso4217:USDxbrli:sharesxbrli:pureutr:sqftxbrli:sharescdak:Renewalcdak:Milestoneiso4217:USDcdak:Tranche

 

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, 2022

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: 001-39615

 

CODIAK BIOSCIENCES, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

47-4926530

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer Identification No.)
 

 

35 CambridgePark Drive, Suite 500

Cambridge, MA

02140

(Address of principal executive offices)

(Zip Code)

(617) 949-4100

(Registrant’s telephone number, including area code)

 

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

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common Stock, par value $0.0001 per share

 

CDAK

 

Nasdaq Global Market

 

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

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

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

 

Large accelerated filer

 

 

Accelerated filer

 

 

 

 

 

Non-accelerated filer

 

 

Smaller reporting company

 

 

 

 

 

 

 

 

 

 

 

 

Emerging growth company

 

 

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

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

As of October 27, 2022, the registrant had 36,829,626 shares of common stock, $0.0001 par value per share, outstanding.

 


Table of Contents

 

 

 

Page

PART I.

 

 

Item 1.

Financial Statements (Unaudited)

4

 

Condensed Consolidated Balance Sheets as of September 30, 2022 and December 31, 2021

4

 

Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2022 and 2021

5

 

Condensed Consolidated Statements of Stockholders' Equity for the three and nine months ended September 30, 2022 and 2021

6

 

Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2022 and 2021

7

 

Notes to Condensed Consolidated Financial Statements

8

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

28

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

49

Item 4.

Controls and Procedures

49

PART II.

 

50

Item 1.

Legal Proceedings

50

Item 1A.

Risk Factors

50

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

52

Item 3.

Defaults Upon Senior Securities

52

Item 4.

Mine Safety Disclosures

52

Item 5.

Other Information

53

Item 6.

Exhibits

54

Signatures

55

 

 

i


 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q contains express or implied forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or our future operational or financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements contained in this Quarterly Report on Form 10-Q include, but are not limited to, statements about:

 

our ability to obtain sufficient funding for our operations, including funding necessary to complete the further development and commercialization of our product candidates and to continue our operations;

 

the success, cost and timing of our product development activities, preclinical studies and clinical trials, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs;

 

the effects on our business of our program reprioritization and restructuring of our operations;

 

the design and conduct of our clinical trials of exoASO-STAT6;

 

our ability to successfully advance any of our engEx product candidates into and through clinical trials, or obtain marketing approval;

 

the potential and capabilities of our engEx Platform, engEx product candidates and engEx discovery programs;

 

the potential and capability of our engEx Platform to generate additional engEx product candidates;

 

our ability to secure from Lonza Rockland, Inc. (“Lonza”), under our manufacturing arrangement with them, sufficient supply of our product candidates for, clinical trials or commercial use, if approved;

 

our ability to successfully procure from third parties sufficient supply of our product candidates for preclinical studies, clinical trials or commercial use, if approved;

 

our ability to utilize our engEx Platform to engineer exosomes to carry various biologically active drug molecules, target specific cell types or cellular pathways or enhance the value of existing drug modalities;

 

the potential indications that we may be able to target with engineered exosomes generated from our engEx Platform;

 

the size, composition and growth potential of the patient populations and markets we intend to target with our engEx product candidates and our ability to develop and commercialize engEx product candidates to address those patient populations and markets;

 

the ability and willingness of our current and future collaborators to continue research and development activities relating to our engEx exosomes;

 

our ability to maintain regulatory approval, if obtained, of any of our current or future engEx product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate;

 

our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates;

 

our ability to license intellectual property relating to our product candidates and to comply with our existing license and collaboration agreements;

 

our ability to commercialize our products, if approved, in light of the intellectual property rights of others;

 

developments relating to the use of exosomes to develop therapeutics;

1


 

 

the success of competing therapies that are or become available;

 

the commercialization of our product candidates, if approved;

 

our plans to research, develop and commercialize our engEx product candidates and enhance the capabilities of our engEx Platform;

 

our ability to attract collaborators with development, regulatory and commercialization expertise;

 

future agreements with third parties in connection with the commercialization of our product candidates and any other approved product;

 

the rate and degree of market acceptance of our product candidates, if approved;

 

regulatory developments in the United States and foreign countries;

 

our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;

 

our ability to attract and retain key scientific or management personnel;

 

our shares of common stock could be delisted from the Nasdaq Global Market which could result in, among other things, a decline in the price of our common stock and less liquidity for holders of shares of our common stock;

 

our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act (the "JOBS Act");

 

the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;

 

the impact of laws and regulations; and

 

the direct or indirect impact of the COVID-19 pandemic on our business, operations, development timelines and the markets and communities in which we and our partners, collaborators, vendors and customers operate.

 

In some cases, you can identify forward-looking statements by terminology such as “may,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue” or the negative of these terms or other comparable terminology. These statements are only predictions. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, which are, in some cases, beyond our control and which could materially affect results. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under “Summary of the Material Risks Associated with Our Business” and under the section titled “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021 ("2021 Annual Report"), and elsewhere in this Quarterly Report on Form 10-Q. If one or more of these risks or uncertainties occur, or if our underlying assumptions prove to be incorrect, actual events or results may vary significantly from those implied or projected by the forward-looking statements. No forward-looking statement is a guarantee of future performance. You should read this Quarterly Report on Form 10-Q and the documents that we reference in this Quarterly Report on Form 10-Q and have filed with the Securities and Exchange Commission as exhibits hereto completely and with the understanding that our actual future results may be materially different from any future results expressed or implied by these forward-looking statements.

 

2


 

The forward-looking statements in this Quarterly Report on Form 10-Q represent our views as of the date of this Quarterly Report on Form 10-Q. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should therefore not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this Quarterly Report on Form 10‑Q.

 

This Quarterly Report on Form 10-Q also contains estimates, projections and other information concerning our industry, our business and the markets for our product candidates. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances that may differ materially from events and circumstances that are assumed in this information. Unless otherwise expressly stated, we obtained this industry, business, market, and other data from our own internal estimates and research as well as from reports, research surveys, studies, and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources. While we are not aware of any misstatements regarding any third-party information presented in this Quarterly Report on Form 10-Q, their estimates, in particular as they relate to projections, involve numerous assumptions, are subject to risks and uncertainties and are subject to change based on various factors, including those discussed under the section titled “Risk Factors” and elsewhere in our 2021 Annual Report, and this Quarterly Report on Form 10-Q.

 

NOTE REGARDING COMPANY REFERENCES

 

Unless the context otherwise requires, the terms “Codiak,” “the Company,” “we,” “us,” and “our” in this Form 10-Q refer to Codiak BioSciences, Inc. and its consolidated subsidiaries.

3


 

 

Item 1. Financial Statements

 

CODIAK BIOSCIENCES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited, in thousands, except share and per share data)

 

 

 

SEPTEMBER 30,

 

 

DECEMBER 31,

 

 

 

2022

 

 

2021

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

51,762

 

 

$

76,938

 

Prepaid manufacturing services

 

 

6,727

 

 

 

7,315

 

Prepaid expenses and other current assets

 

 

2,744

 

 

 

5,918

 

Total current assets

 

 

61,233

 

 

 

90,171

 

Property and equipment, net of accumulated depreciation of $14,990 and $11,809

 

 

20,538

 

 

 

23,479

 

Restricted cash

 

 

4,170

 

 

 

4,170

 

Operating right-of-use assets

 

 

20,955

 

 

 

21,957

 

Prepaid manufacturing services, net of current portion

 

 

27,500

 

 

 

31,893

 

Total assets

 

$

134,396

 

 

$

171,670

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

1,956

 

 

$

1,838

 

Accrued expenses

 

 

8,126

 

 

 

9,703

 

Deferred revenue

 

 

1,363

 

 

 

12,963

 

Operating lease liabilities

 

 

3,011

 

 

 

2,661

 

Total current liabilities

 

 

14,456

 

 

 

27,165

 

Long-term liabilities:

 

 

 

 

 

 

Deferred revenue, net of current portion

 

 

17,317

 

 

 

30,686

 

Note payable, net of discount

 

 

25,693

 

 

 

25,430

 

Derivative liability - warrants

 

 

5,428

 

 

 

 

Operating lease liabilities, net of current portion

 

 

32,573

 

 

 

34,884

 

Total liabilities

 

 

95,467

 

 

 

118,165

 

Commitments and contingencies (Note 7)

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Common stock, $0.0001 par value; 150,000,000 shares authorized as of September 30, 2022 and December 31, 2021; 36,829,626 and 22,383,830 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively

 

 

4

 

 

 

2

 

Additional paid-in capital

 

 

398,253

 

 

 

378,750

 

Accumulated deficit

 

 

(359,328

)

 

 

(325,247

)

Total stockholders’ equity

 

 

38,929

 

 

 

53,505

 

Total liabilities and stockholders’ equity

 

$

134,396

 

 

$

171,670

 

 

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

4


 

CODIAK BIOSCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited, in thousands, except share and per share data)

 

 

 

THREE MONTHS ENDED
SEPTEMBER 30,

 

 

NINE MONTHS ENDED
SEPTEMBER 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

Collaboration revenue

 

$

28

 

 

$

1,157

 

 

$

25,877

 

 

$

15,238

 

Grant revenue

 

494

 

 

 

 

 

494

 

 

 

 

Total revenue

 

 

522

 

 

 

1,157

 

 

 

26,371

 

 

 

15,238

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

10,847

 

 

 

15,467

 

 

 

37,893

 

 

 

47,436

 

General and administrative

 

 

6,563

 

 

 

7,186

 

 

 

20,634

 

 

 

20,711

 

Impairment of prepaid manufacturing services

 

 

4,508

 

 

 

 

 

 

4,508

 

 

 

 

Total operating expenses

 

 

21,918

 

 

 

22,653

 

 

 

63,035

 

 

 

68,147

 

Loss from operations

 

 

(21,396

)

 

 

(21,496

)

 

 

(36,664

)

 

 

(52,909

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(758

)

 

 

(689

)

 

 

(2,007

)

 

 

(2,091

)

Interest income

 

 

119

 

 

 

4

 

 

 

157

 

 

 

18

 

Other income

 

 

35

 

 

 

479

 

 

 

1,711

 

 

 

1,163

 

Change in fair value of derivative liability - warrants

 

 

2,722

 

 

 

 

 

 

2,722

 

 

 

 

Total other income (expense), net

 

 

2,118

 

 

 

(206

)

 

 

2,583

 

 

 

(910

)

Net loss

 

$

(19,278

)

 

$

(21,702

)

 

$

(34,081

)

 

$

(53,819

)

Net loss per share attributable to common stockholders, basic and diluted

 

$

(0.77

)

 

$

(0.97

)

 

$

(1.46

)

 

$

(2.49

)

Weighted average common shares outstanding, basic and diluted

 

 

25,159,757

 

 

 

22,325,334

 

 

 

23,373,684

 

 

 

21,599,405

 

 

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

5


 

CODIAK BIOSCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2022 AND 2021

(Unaudited, in thousands, except share data)

 

 

 

COMMON
STOCK

 

 

ADDITIONAL
PAID-IN

 

 

ACCUMULATED

 

 

TOTAL
STOCKHOLDERS

 

 

 

SHARES

 

 

AMOUNT

 

 

CAPITAL

 

 

DEFICIT

 

 

EQUITY

 

Balance at December 31, 2021

 

 

22,383,830

 

 

$

2

 

 

$

378,750

 

 

$

(325,247

)

 

$

53,505

 

Stock-based compensation

 

 

 

 

 

 

 

 

2,349

 

 

 

 

 

 

2,349

 

Issuance of common stock in at-the-market offering, net of issuance costs of $17

 

 

110,037

 

 

 

 

 

 

553

 

 

 

 

 

 

553

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(8,028

)

 

 

(8,028

)

Balance at March 31, 2022

 

 

22,493,867

 

 

 

2

 

 

 

381,652

 

 

 

(333,275

)

 

 

48,379

 

Common stock issued under Employee Stock Purchase Plan (ESPP)

 

 

51,664

 

 

 

 

 

 

126

 

 

 

 

 

 

126

 

Stock-based compensation

 

 

 

 

 

 

 

 

2,668

 

 

 

 

 

 

2,668

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(6,775

)

 

 

(6,775

)

Balance at June 30, 2022

 

 

22,545,531

 

 

 

2

 

 

 

384,446

 

 

 

(340,050

)

 

 

44,398

 

Stock-based compensation

 

 

 

 

 

 

 

 

2,287

 

 

 

 

 

 

2,287

 

Issuance of common stock in at-the-market offering, net of issuance costs of $12

 

 

126,266

 

 

 

 

 

 

384

 

 

 

 

 

 

384

 

Issuance of common stock, net of issuance costs of $491 and warrant $8,150

 

 

14,027,665

 

 

 

2

 

 

 

11,136

 

 

 

 

 

 

11,138

 

Issuance of common stock from restricted stock units

 

 

130,164

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(19,278

)

 

 

(19,278

)

Balance at September 30, 2022

 

 

36,829,626

 

 

$

4

 

 

$

398,253

 

 

$

(359,328

)

 

$

38,929

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

COMMON
STOCK

 

 

ADDITIONAL
PAID-IN

 

 

ACCUMULATED

 

 

TOTAL
STOCKHOLDERS

 

 

 

SHARES

 

 

AMOUNT

 

 

CAPITAL

 

 

DEFICIT

 

 

EQUITY

 

Balance at December 31, 2020

 

 

18,787,579

 

 

$

2

 

 

$

302,655

 

 

$

(288,090

)

 

$

14,567

 

Exercise of options to purchase common stock

 

 

46,807

 

 

 

 

 

 

316

 

 

 

 

 

 

316

 

Stock-based compensation

 

 

 

 

 

 

 

 

2,273

 

 

 

 

 

 

2,273

 

Issuance of common stock upon public offering, net of issuance costs of $560

 

 

3,162,500

 

 

 

 

 

 

61,868

 

 

 

 

 

 

61,868

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(10,308

)

 

 

(10,308

)

Balance at March 31, 2021

 

 

21,996,886

 

 

 

2

 

 

 

367,112

 

 

 

(298,398

)

 

 

68,716

 

Exercise of options to purchase common stock

 

 

276,089

 

 

 

 

 

 

2,454

 

 

 

 

 

 

2,454

 

Stock-based compensation

 

 

 

 

 

 

 

 

2,690

 

 

 

 

 

 

2,690

 

Issuance costs related to common stock

 

 

 

 

 

 

 

 

(187

)

 

 

 

 

 

(187

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(21,809

)

 

 

(21,809

)

Balance at June 30, 2021

 

 

22,272,975

 

 

 

2

 

 

 

372,069

 

 

 

(320,207

)

 

 

51,864

 

Exercise of options to purchase common stock

 

 

88,330

 

 

 

 

 

 

752

 

 

 

 

 

 

752

 

Stock-based compensation

 

 

 

 

 

 

 

 

3,092

 

 

 

 

 

 

3,092

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(21,702

)

 

 

(21,702

)

Balance at September 30, 2021

 

 

22,361,305

 

 

$

2

 

 

$

375,913

 

 

$

(341,909

)

 

$

34,006

 

 

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

6


 

CODIAK BIOSCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited, in thousands)

 

 

 

NINE MONTHS ENDED
SEPTEMBER 30,

 

 

 

2022

 

 

2021

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(34,081

)

 

$

(53,819

)

Adjustments to reconcile net loss to net cash from operating activities:

 

 

 

 

 

 

Stock-based compensation expense

 

 

7,304

 

 

 

8,055

 

Change in fair value of derivative liability - warrants

 

 

(2,722

)

 

 

 

Impairment of prepaid manufacturing services

 

 

4,508

 

 

 

 

Non-cash interest expense

 

 

308

 

 

 

392

 

Depreciation and amortization expense

 

 

3,181

 

 

 

4,205

 

Non-cash manufacturing expense

 

 

462

 

 

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

2,949

 

 

 

(651

)

Prepaid manufacturing services

 

 

12

 

 

 

 

Operating right-of-use assets

 

 

1,003

 

 

 

745

 

Accounts payable

 

 

175

 

 

 

206

 

Accrued expenses

 

 

(1,725

)

 

 

1,118

 

Deferred revenue

 

 

(