false Q2 --12-31 0001718852 0.1 true true true true true true true P6M P6M 0.1 P4Y P7Y P10Y P4Y P5Y 28063500 28001000 3500000 3500000 5000000 5000000 12000 P9Y P9Y2M12D P9Y3M18D P8Y8M12D P8Y8M12D P6Y8M12D P6Y1M6D P6Y1M6D 0.010 0.006 0.005 0.011 0.011 0.014 0.730 0.730 0.615 0.742 0.952 0.681 P5Y9M18D P5Y9M18D P6Y1M6D P6Y1M6D 86775740 73763000 7219560 6144000 0001718852 2021-01-01 2021-06-30 xbrli:shares 0001718852 2021-08-09 iso4217:USD 0001718852 2021-06-30 0001718852 2020-12-31 iso4217:USD xbrli:shares 0001718852 2021-04-01 2021-06-30 0001718852 2020-04-01 2020-06-30 0001718852 2020-01-01 2020-06-30 0001718852 us-gaap:ConvertiblePreferredStockMember 2020-12-31 0001718852 us-gaap:CommonStockMember 2020-12-31 0001718852 us-gaap:AdditionalPaidInCapitalMember 2020-12-31 0001718852 us-gaap:RetainedEarningsMember 2020-12-31 0001718852 rxdx:SeriesDTwoConvertiblePreferredStockMember 2021-01-01 2021-03-31 0001718852 us-gaap:ConvertiblePreferredStockMember 2021-01-01 2021-03-31 0001718852 us-gaap:CommonStockMember 2021-01-01 2021-03-31 0001718852 us-gaap:AdditionalPaidInCapitalMember 2021-01-01 2021-03-31 0001718852 2021-01-01 2021-03-31 0001718852 us-gaap:RetainedEarningsMember 2021-01-01 2021-03-31 0001718852 us-gaap:CommonStockMember 2021-03-31 0001718852 us-gaap:AdditionalPaidInCapitalMember 2021-03-31 0001718852 us-gaap:RetainedEarningsMember 2021-03-31 0001718852 2021-03-31 0001718852 us-gaap:AdditionalPaidInCapitalMember 2021-04-01 2021-06-30 0001718852 us-gaap:CommonStockMember 2021-04-01 2021-06-30 0001718852 us-gaap:RetainedEarningsMember 2021-04-01 2021-06-30 0001718852 us-gaap:CommonStockMember 2021-06-30 0001718852 us-gaap:AdditionalPaidInCapitalMember 2021-06-30 0001718852 us-gaap:RetainedEarningsMember 2021-06-30 0001718852 us-gaap:SeriesCPreferredStockMember 2020-01-01 2020-03-31 0001718852 us-gaap:ConvertiblePreferredStockMember 2019-12-31 0001718852 us-gaap:CommonStockMember 2019-12-31 0001718852 us-gaap:AdditionalPaidInCapitalMember 2019-12-31 0001718852 us-gaap:RetainedEarningsMember 2019-12-31 0001718852 2019-12-31 0001718852 us-gaap:CommonStockMember 2020-01-01 2020-03-31 0001718852 us-gaap:AdditionalPaidInCapitalMember 2020-01-01 2020-03-31 0001718852 2020-01-01 2020-03-31 0001718852 us-gaap:RetainedEarningsMember 2020-01-01 2020-03-31 0001718852 us-gaap:ConvertiblePreferredStockMember 2020-03-31 0001718852 us-gaap:CommonStockMember 2020-03-31 0001718852 us-gaap:AdditionalPaidInCapitalMember 2020-03-31 0001718852 us-gaap:RetainedEarningsMember 2020-03-31 0001718852 2020-03-31 0001718852 us-gaap:SeriesCPreferredStockMember 2020-04-01 2020-06-30 0001718852 us-gaap:CommonStockMember 2020-04-01 2020-06-30 0001718852 us-gaap:AdditionalPaidInCapitalMember 2020-04-01 2020-06-30 0001718852 us-gaap:RetainedEarningsMember 2020-04-01 2020-06-30 0001718852 us-gaap:ConvertiblePreferredStockMember 2020-06-30 0001718852 us-gaap:CommonStockMember 2020-06-30 0001718852 us-gaap:AdditionalPaidInCapitalMember 2020-06-30 0001718852 us-gaap:RetainedEarningsMember 2020-06-30 0001718852 2020-06-30 0001718852 us-gaap:SeriesDPreferredStockMember 2021-01-01 2021-06-30 0001718852 rxdx:SeriesDTwoConvertiblePreferredStockMember 2021-01-01 2021-06-30 0001718852 us-gaap:SeriesCPreferredStockMember 2020-01-01 2020-06-30 xbrli:pure 0001718852 2020-01-01 2020-12-31 0001718852 2021-03-05 2021-03-05 0001718852 us-gaap:IPOMember 2021-03-16 2021-03-16 0001718852 us-gaap:OverAllotmentOptionMember 2021-03-16 2021-03-16 0001718852 us-gaap:IPOMember 2021-03-16 0001718852 us-gaap:ConvertiblePreferredStockMember us-gaap:CommonStockMember 2021-03-16 2021-03-16 0001718852 us-gaap:ConvertiblePreferredStockMember 2021-03-16 0001718852 rxdx:ConvertiblePreferredStockWarrantLiabilityMember us-gaap:CommonStockMember 2021-03-16 2021-03-16 0001718852 2021-03-16 0001718852 us-gaap:ConvertiblePreferredStockMember 2020-01-01 2020-06-30 0001718852 rxdx:CommonStockOptionsIssuedAndOutstandingMember 2021-01-01 2021-06-30 0001718852 rxdx:CommonStockOptionsIssuedAndOutstandingMember 2020-01-01 2020-06-30 0001718852 rxdx:WarrantsToPurchaseCommonStockMember 2021-01-01 2021-06-30 0001718852 rxdx:WarrantsToPurchaseConvertiblePreferredStockOutstandingMember 2020-01-01 2020-06-30 0001718852 us-gaap:EmployeeStockMember 2021-01-01 2021-06-30 0001718852 us-gaap:AccountingStandardsUpdate201602Member 2021-06-30 0001718852 us-gaap:AccountingStandardsUpdate201613Member 2021-06-30 0001718852 rxdx:AccountingStandardsUpdate202006Member 2021-06-30 0001718852 rxdx:ConvertiblePreferredStockWarrantLiabilityMember 2021-03-16 0001718852 rxdx:ConvertiblePreferredStockWarrantLiabilityMember 2020-12-31 0001718852 us-gaap:MeasurementInputRiskFreeInterestRateMember rxdx:ConvertiblePreferredStockWarrantLiabilityMember 2021-03-16 0001718852 us-gaap:MeasurementInputRiskFreeInterestRateMember rxdx:ConvertiblePreferredStockWarrantLiabilityMember 2020-12-31 0001718852 us-gaap:MeasurementInputPriceVolatilityMember rxdx:ConvertiblePreferredStockWarrantLiabilityMember 2021-03-16 0001718852 us-gaap:MeasurementInputPriceVolatilityMember rxdx:ConvertiblePreferredStockWarrantLiabilityMember 2020-12-31 0001718852 us-gaap:MeasurementInputExpectedTermMember rxdx:ConvertiblePreferredStockWarrantLiabilityMember 2021-03-16 0001718852 us-gaap:MeasurementInputExpectedTermMember rxdx:ConvertiblePreferredStockWarrantLiabilityMember 2020-12-31 0001718852 us-gaap:MeasurementInputRiskFreeInterestRateMember 2020-12-31 0001718852 rxdx:MeasurementInputTrancheMember 2020-12-31 0001718852 us-gaap:MeasurementInputPriceVolatilityMember 2020-12-31 0001718852 rxdx:ConvertiblePreferredStockWarrantLiabilityMember 2020-12-31 0001718852 rxdx:SeriesDConvertiblePreferredStockWarrantLiabilityMember 2020-12-31 0001718852 rxdx:ConvertiblePreferredStockWarrantLiabilityMember 2021-01-01 2021-06-30 0001718852 rxdx:SeriesDConvertiblePreferredStockWarrantLiabilityMember 2021-01-01 2021-06-30 0001718852 rxdx:ConvertiblePreferredStockWarrantLiabilityMember 2021-06-30 0001718852 rxdx:SeriesDConvertiblePreferredStockWarrantLiabilityMember 2021-06-30 0001718852 rxdx:LaboratoryEquipmentMember 2021-06-30 0001718852 rxdx:LaboratoryEquipmentMember 2020-12-31 0001718852 us-gaap:OfficeEquipmentMember 2021-06-30 0001718852 us-gaap:OfficeEquipmentMember 2020-12-31 0001718852 rxdx:CedarsSinaiAgreementMember rxdx:CedarsSinaiMedicalCenterMember rxdx:VestedCommonStockMember 2017-09-30 0001718852 rxdx:CedarsSinaiAgreementMember rxdx:CedarsSinaiMedicalCenterMember rxdx:UnvestedRestrictedCommonStockMember 2017-09-30 0001718852 rxdx:CompanionDiagnosticsDevelopmentAndCollaborationAgreementMember rxdx:TakedaPharmaceuticalCompanyLimitedMember 2019-03-01 2019-03-31 0001718852 rxdx:CompanionDiagnosticsDevelopmentAndCollaborationAgreementMember rxdx:TakedaPharmaceuticalCompanyLimitedMember srt:MaximumMember 2019-03-31 0001718852 rxdx:CompanionDiagnosticsDevelopmentAndCollaborationAgreementMember rxdx:TakedaPharmaceuticalCompanyLimitedMember 2021-04-01 2021-06-30 0001718852 rxdx:CompanionDiagnosticsDevelopmentAndCollaborationAgreementMember rxdx:TakedaPharmaceuticalCompanyLimitedMember 2020-04-01 2020-06-30 0001718852 rxdx:CompanionDiagnosticsDevelopmentAndCollaborationAgreementMember rxdx:TakedaPharmaceuticalCompanyLimitedMember 2021-01-01 2021-06-30 0001718852 rxdx:CompanionDiagnosticsDevelopmentAndCollaborationAgreementMember rxdx:TakedaPharmaceuticalCompanyLimitedMember 2020-01-01 2020-06-30 0001718852 rxdx:CompanionDiagnosticsDevelopmentAndCollaborationAgreementMember rxdx:TakedaPharmaceuticalCompanyLimitedMember 2021-06-30 0001718852 rxdx:CompanionDiagnosticsDevelopmentAndCollaborationAgreementMember rxdx:TakedaPharmaceuticalCompanyLimitedMember 2020-12-31 0001718852 rxdx:CompanionDiagnosticsDevelopmentAndCollaborationAgreementMember rxdx:TakedaPharmaceuticalCompanyLimitedMember 2021-07-01 2021-06-30 0001718852 2021-07-01 rxdx:CompanionDiagnosticsDevelopmentAndCollaborationAgreementMember 2021-06-30 0001718852 rxdx:CoDevelopmentAndManufacturingAgreementMember rxdx:DrFalkPharmaGMBHMember 2020-07-01 2020-07-31 rxdx:Milestone 0001718852 rxdx:CoDevelopmentAndManufacturingAgreementMember rxdx:DrFalkPharmaGMBHMember 2020-07-31 0001718852 rxdx:CoDevelopmentAndManufacturingAgreementMember rxdx:DrFalkPharmaGMBHMember 2020-12-01 2020-12-31 0001718852 rxdx:CoDevelopmentAndManufacturingAgreementMember rxdx:DrFalkPharmaGMBHMember 2021-06-01 2021-06-30 0001718852 rxdx:CoDevelopmentAndManufacturingAgreementMember rxdx:DrFalkPharmaGMBHMember 2021-04-01 2021-06-30 0001718852 rxdx:CoDevelopmentAndManufacturingAgreementMember rxdx:DrFalkPharmaGMBHMember 2021-01-01 2021-06-30 0001718852 rxdx:CoDevelopmentAndManufacturingAgreementMember rxdx:DrFalkPharmaGMBHMember 2021-06-30 0001718852 rxdx:CoDevelopmentAndManufacturingAgreementMember rxdx:DrFalkPharmaGMBHMember 2020-12-31 0001718852 rxdx:CoDevelopmentAndManufacturingAgreementMember rxdx:DrFalkPharmaGMBHMember 2021-07-01 2021-06-30 0001718852 2021-07-01 rxdx:CoDevelopmentAndManufacturingAgreementMember 2021-06-30 0001718852 rxdx:CompanionDiagnosticsDevelopmentAndCollaborationAgreementMember 2020-12-31 0001718852 rxdx:CompanionDiagnosticsDevelopmentAndCollaborationAgreementMember 2021-01-01 2021-06-30 0001718852 rxdx:CompanionDiagnosticsDevelopmentAndCollaborationAgreementMember 2021-06-30 0001718852 rxdx:PrometheusLaboratoriesIncMember 2019-06-30 0001718852 rxdx:PrometheusLaboratoriesIncMember 2019-06-30 2019-06-30 0001718852 rxdx:PrometheusLaboratoriesIncMember rxdx:SeriesCConvertiblePreferredStockMember 2019-06-30 2019-06-30 0001718852 rxdx:PrometheusLaboratoriesIncMember 2020-06-01 2020-06-30 0001718852 rxdx:PrometheusLaboratoriesIncMember rxdx:SeriesCConvertiblePreferredStockMember 2020-06-01 2020-06-30 0001718852 rxdx:PrometheusLaboratoriesIncMember 2020-10-01 2020-10-31 0001718852 rxdx:PrometheusLaboratoriesIncMember rxdx:SeriesDConvertiblePreferredStockMember 2020-10-01 2020-10-31 0001718852 rxdx:PrometheusLaboratoriesIncMember rxdx:SeriesDTwoConvertiblePreferredStockMember 2021-01-01 2021-01-31 0001718852 rxdx:PrometheusLaboratoriesIncMember 2021-06-30 0001718852 rxdx:PrometheusLaboratoriesIncMember 2020-12-31 0001718852 rxdx:PrometheusLaboratoriesIncMember us-gaap:DiscontinuedOperationsDisposedOfByMeansOtherThanSaleSpinoffMember 2020-12-31 utr:sqft 0001718852 rxdx:PrometheusLaboratoriesIncMember us-gaap:DiscontinuedOperationsDisposedOfByMeansOtherThanSaleSpinoffMember 2020-01-01 2020-12-31 0001718852 rxdx:PrometheusLaboratoriesIncMember us-gaap:DiscontinuedOperationsDisposedOfByMeansOtherThanSaleSpinoffMember 2020-04-01 2020-06-30 0001718852 rxdx:PrometheusLaboratoriesIncMember us-gaap:DiscontinuedOperationsDisposedOfByMeansOtherThanSaleSpinoffMember 2020-01-01 2020-06-30 0001718852 rxdx:OxfordFinanceLLCMember 2020-01-31 0001718852 rxdx:OxfordFinanceLLCMember 2020-01-01 2020-01-31 0001718852 rxdx:OxfordFinanceLLCMember 2021-06-30 0001718852 rxdx:OxfordFinanceLLCMember rxdx:SeriesCConvertiblePreferredStockMember 2020-01-31 0001718852 rxdx:OxfordFinanceLLCMember rxdx:SeriesCConvertiblePreferredStockMember 2021-03-16 2021-03-16 0001718852 rxdx:OxfordFinanceLLCMember rxdx:SeriesCConvertiblePreferredStockMember 2021-03-16 0001718852 rxdx:OxfordFinanceLLCMember rxdx:SeriesCConvertiblePreferredStockMember 2020-01-01 2020-01-31 0001718852 us-gaap:SubsequentEventMember rxdx:OxfordFinanceLLCMember 2021-07-08 2021-07-08 0001718852 us-gaap:SubsequentEventMember rxdx:OxfordFinanceLLCMember 2021-07-08 0001718852 rxdx:SeriesCConvertiblePreferredStockMember 2020-03-01 2020-03-31 0001718852 rxdx:SeriesDOneConvertiblePreferredStockMember 2020-10-01 2020-10-31 0001718852 rxdx:SeriesDOneConvertiblePreferredStockMember 2020-10-31 0001718852 rxdx:SeriesDTwoConvertiblePreferredStockMember 2020-10-01 2020-10-31 0001718852 rxdx:SeriesDTwoConvertiblePreferredStockMember 2020-10-31 0001718852 us-gaap:SeriesDPreferredStockMember 2020-10-31 0001718852 rxdx:SeriesDTwoConvertiblePreferredStockMember 2021-01-01 2021-01-31 0001718852 rxdx:SeriesDTwoConvertiblePreferredStockMember 2021-04-01 2021-06-30 0001718852 us-gaap:SeriesAPreferredStockMember 2020-12-31 0001718852 us-gaap:SeriesBPreferredStockMember 2020-12-31 0001718852 rxdx:SeriesCConvertiblePreferredStockMember 2020-12-31 0001718852 rxdx:SeriesDOneConvertiblePreferredStockMember 2020-12-31 0001718852 rxdx:SeriesDTwoConvertiblePreferredStockMember 2020-12-31 0001718852 rxdx:TwoThousandAndSeventeenEquityIncentivePlanMember 2017-12-31 0001718852 rxdx:TwoThousandAndSeventeenEquityIncentivePlanMember 2017-01-01 2017-12-31 0001718852 rxdx:TwoThousandAndSeventeenEquityIncentivePlanMember us-gaap:ShareBasedCompensationAwardTrancheOneMember 2017-01-01 2017-12-31 0001718852 rxdx:TwoThousandAndTwentyOneIncentiveAwardPlanMember 2021-02-28 0001718852 rxdx:TwoThousandAndTwentyOneIncentiveAwardPlanMember 2021-06-30 0001718852 rxdx:TwoThousandAndTwentyOneIncentiveAwardPlanMember 2021-02-01 2021-02-28 0001718852 srt:MinimumMember 2021-04-01 2021-06-30 0001718852 srt:MinimumMember 2021-01-01 2021-06-30 0001718852 srt:MaximumMember 2021-04-01 2021-06-30 0001718852 srt:MaximumMember 2021-01-01 2021-06-30 0001718852 us-gaap:EmployeeStockMember 2021-02-01 2021-02-28 0001718852 us-gaap:EmployeeStockMember 2021-02-28 0001718852 us-gaap:EmployeeStockMember 2020-01-01 2020-06-30 0001718852 us-gaap:EmployeeStockMember 2021-06-30 0001718852 us-gaap:ResearchAndDevelopmentExpenseMember 2021-04-01 2021-06-30 0001718852 us-gaap:ResearchAndDevelopmentExpenseMember 2020-04-01 2020-06-30 0001718852 us-gaap:ResearchAndDevelopmentExpenseMember 2021-01-01 2021-06-30 0001718852 us-gaap:ResearchAndDevelopmentExpenseMember 2020-01-01 2020-06-30 0001718852 us-gaap:GeneralAndAdministrativeExpenseMember 2021-04-01 2021-06-30 0001718852 us-gaap:GeneralAndAdministrativeExpenseMember 2020-04-01 2020-06-30 0001718852 us-gaap:GeneralAndAdministrativeExpenseMember 2021-01-01 2021-06-30 0001718852 us-gaap:GeneralAndAdministrativeExpenseMember 2020-01-01 2020-06-30 0001718852 us-gaap:SegmentDiscontinuedOperationsMember 2020-04-01 2020-06-30 0001718852 us-gaap:SegmentDiscontinuedOperationsMember 2020-01-01 2020-06-30 0001718852 rxdx:PrometheusLaboratoriesIncMember 2020-12-30 2020-12-31 0001718852 rxdx:PrometheusLaboratoriesIncMember 2021-01-01 2021-06-30 0001718852 rxdx:PrometheusLaboratoriesIncMember 2020-01-01 2020-12-31 0001718852 rxdx:OfficeAndLaboratorySpaceSanDiegoMember 2021-03-01 2021-03-31 0001718852 srt:MaximumMember rxdx:OfficeAndLaboratorySpaceSanDiegoMember 2021-03-01 2021-03-31 0001718852 rxdx:OfficeAndLaboratorySpaceSanDiegoMember 2021-01-01 2021-06-30 0001718852 rxdx:OfficeAndLaboratorySpaceSanDiegoMember 2021-06-30 0001718852 rxdx:CedarsSinaiMedicalCenterMember rxdx:CedarsSinaiAgreementMember rxdx:VestedCommonStockMember 2017-09-30 0001718852 rxdx:CedarsSinaiMedicalCenterMember rxdx:CedarsSinaiAgreementMember rxdx:UnvestedRestrictedCommonStockMember 2017-09-30 rxdx:Employee 0001718852 rxdx:NestleMember 2020-12-31 0001718852 us-gaap:SpinoffMember rxdx:TransitionServicesAgreementMember 2020-12-31 0001718852 us-gaap:SpinoffMember rxdx:TransitionServicesAgreementMember 2020-01-01 2020-12-31 0001718852 rxdx:TransitionServicesAgreementMember 2021-04-01 2021-06-30 0001718852 rxdx:TransitionServicesAgreementMember 2021-01-01 2021-06-30

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

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

For the quarterly period ended June 30, 2021

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: 001-40187

 

PROMETHEUS BIOSCIENCES, INC.

(Exact name of Registrant as specified in its charter)

 

 

Delaware

 

82-4282653

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

 

 

9410 Carroll Park Drive

San Diego, California

 

92121

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (858) 684-1300

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

 

Title of each class

 

Trading Symbol(s)

 

Name of each exchange on which registered

Common Stock, $0.0001 par value per share

 

RXDX

 

Nasdaq Global Select 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 August 9, 2021, the registrant had 38,865,986 shares of common stock ($0.0001 par value) outstanding.

 

 

 


 

 

TABLE OF CONTENTS

 

PART I. FINANCIAL INFORMATION

 

Item 1

 

Unaudited Condensed Consolidated Financial Statements

2

 

 

Unaudited Condensed Consolidated Balance Sheets

2

 

 

Unaudited Condensed Consolidated Statements of Operations

3

 

 

Unaudited Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)

4

 

 

Unaudited Condensed Consolidated Statements of Cash Flows

6

 

 

Notes to Unaudited Condensed Consolidated Financial Statements

7

Item 2

 

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

22

Item 3

 

Quantitative and Qualitative Disclosures About Market Risk

33

Item 4

 

Controls and Procedures

33

 

PART II. OTHER INFORMATION

 

Item 1

 

Legal Proceedings

34

Item 1A

 

Risk Factors

34

Item 2

 

Unregistered Sales of Equity Securities and Use of Proceeds

34

Item 3

 

Defaults Upon Senior Securities

34

Item 4

 

Mine Safety Disclosures

34

Item 5

 

Other Information

34

Item 6

 

Exhibits

35

 

 

Exhibit Index

 

 

 

Signatures

36

 

 

1

 


 

PART I. FINANCIAL INFORMATION

Item 1.Financial Statements (unaudited)

 

PROMETHEUS BIOSCIENCES, INC.

Unaudited Condensed Consolidated Balance Sheets

(in thousands, except share and par value amounts)

 

 

 

June 30,

2021

 

 

December 31,

2020

 

Assets

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

304,389

 

 

$

54,201

 

Accounts receivable

 

 

217

 

 

 

1,086

 

Prepaid expenses and other current assets

 

 

6,983

 

 

 

2,169

 

Total current assets

 

 

311,589

 

 

 

57,456

 

Equipment, net

 

 

1,109

 

 

 

447

 

Deferred financing costs

 

 

 

 

 

1,730

 

Other assets

 

 

468

 

 

 

 

Total assets

 

$

313,166

 

 

$

59,633

 

Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit)

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

 

Accounts payable

 

$

2,250

 

 

$

958

 

Accrued compensation

 

 

2,398

 

 

 

2,722

 

Accrued expenses and other current liabilities

 

 

2,735

 

 

 

2,894

 

Amounts due to Nestlé, current—related party

 

 

 

 

 

5,675

 

Payable to PLI

 

 

233

 

 

 

1,130

 

Deferred revenue

 

 

2,686

 

 

 

1,876

 

      Long-term debt, net - current portion

 

 

7,396

 

 

 

 

Total current liabilities

 

 

17,698

 

 

 

15,255

 

Long-term debt, net

 

 

 

 

 

7,399

 

Deferred revenue, non-current

 

 

13,040

 

 

 

4,597

 

Preferred stock purchase right liability

 

 

 

 

 

3,900

 

Total liabilities

 

 

30,738

 

 

 

31,151

 

Commitments and contingencies (Note 9)

 

 

 

 

 

 

 

 

Convertible preferred stock—$0.0001 par value; No shares and 254,983,985 shares

   authorized at June 30, 2021 and December 31, 2020, respectively; No shares and

   160,864,434 shares issued and outstanding at June 30, 2021 and December 31,

   2020, respectively; liquidation preferences of $0 and $130,487 at June 30, 2021

   and December 31, 2020, respectively

 

 

 

 

 

126,023

 

Stockholders’ equity (deficit):

 

 

 

 

 

 

 

 

Preferred stock—$0.0001 par value; 40,000,000 shares and no shares authorized

   at June 30, 2021 and December 31, 2020, respectively; No shares issued

   and outstanding at June 30, 2021 and December 31, 2020

 

 

 

 

 

 

Common stock—$0.0001 par value; 400,000,000 shares and 325,000,000 shares

   authorized as of June 30, 2021 and December 31, 2020, respectively; 38,865,986

   shares and 1,768,325 shares issued at June 30, 2021 and December 31, 2020,

   respectively; 38,835,067 shares and 1,713,622 shares outstanding at June 30,

   2021 and December 31, 2020, respectively;

 

 

4

 

 

 

 

Additional-paid in capital

 

 

414,514

 

 

 

1,605

 

Accumulated deficit

 

 

(132,090

)

 

 

(99,146

)

Total stockholders’ equity (deficit)

 

 

282,428

 

 

 

(97,541

)

Total liabilities, convertible preferred stock and stockholders’ equity (deficit)

 

$

313,166

 

 

$

59,633

 

 

See accompanying notes.

2

 


 

PROMETHEUS BIOSCIENCES, INC.

Unaudited Condensed Consolidated Statements of Operations

(in thousands, except share and per share amounts)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Collaboration revenue

 

$

326

 

 

$

179

 

 

$

1,086

 

 

$

407

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

13,554

 

 

 

4,923

 

 

 

21,312

 

 

 

9,188

 

General and administrative

 

 

5,618

 

 

 

1,810

 

 

 

10,840

 

 

 

4,197

 

Total operating expense

 

 

19,172

 

 

 

6,733

 

 

 

32,152

 

 

 

13,385

 

Loss from operations

 

 

(18,846

)

 

 

(6,554

)

 

 

(31,066

)

 

 

(12,978

)

Other income (expense), net:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

37

 

 

 

3

 

 

 

55

 

 

 

5

 

Interest expense

 

 

(190

)

 

 

(595

)

 

 

(848

)

 

 

(1,129

)

Change in fair value of preferred stock purchase right liability

 

 

 

 

 

 

 

 

(980

)

 

 

 

Change in fair value of preferred stock warrant liability

 

 

 

 

 

(5

)

 

 

(105

)

 

 

(3

)

Total other income (expense), net

 

 

(153

)

 

 

(597

)

 

 

(1,878

)

 

 

(1,127

)

Loss from continuing operations

 

 

(18,999

)

 

 

(7,151

)

 

 

(32,944

)

 

 

(14,105

)

Loss from discontinued operations

 

 

 

 

 

(1,289

)

 

 

 

 

 

(7,463

)

Net loss

 

$

(18,999

)

 

$

(8,440

)

 

$

(32,944

)

 

$

(21,568

)

Net loss per share, basic and diluted:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Continuing operations

 

$

(0.49

)

 

$

(5.02

)

 

$

(1.39

)

 

$

(10.08

)

Discontinued operations

 

 

 

 

 

(0.90

)

 

 

 

 

 

(5.34

)

Net loss per share, basic and diluted

 

$

(0.49

)

 

$

(5.93

)

 

$

(1.39

)

 

$

(15.42

)

Weighted average shares outstanding, basic and diluted

 

 

38,813,865

 

 

 

1,424,445

 

 

 

23,660,559

 

 

 

1,398,748

 

 

See accompanying notes.

3


 

PROMETHEUS BIOSCIENCES, INC.

Unaudited Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)

(in thousands, except share amounts)

 

 

 

Convertible

Preferred Stock

 

 

 

Common Stock

 

 

Additional

Paid-in

 

 

Accumulated

 

 

Total

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Deficit

 

Balance at December 31, 2020

 

 

160,864,434

 

 

$

126,023

 

 

 

 

1,713,622

 

 

$

 

 

$

1,605

 

 

$

(99,146

)

 

$

(97,541

)

Issuance of Series D-2 convertible preferred

   stock for cash, net of issuance costs of $94

 

 

86,775,740

 

 

 

73,763

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of Series D-2 convertible preferred

   stock for settlement of deferred purchase

   price

 

 

7,219,560

 

 

 

6,144

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Reclassification of convertible preferred stock

   purchase right liability

 

 

 

 

 

4,880

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conversion of convertible preferred stock into

   common stock at initial public offering

 

 

(254,859,734

)

 

 

(210,810

)

 

 

 

25,485,955

 

 

 

3

 

 

 

210,807

 

 

 

 

 

 

210,810

 

Issuance of shares of common stock in initial

   public offering for cash, net of issuance

   costs of $18,662

 

 

 

 

 

 

 

 

 

11,500,000

 

 

 

1

 

 

 

199,837

 

 

 

 

 

 

199,838

 

Reclassification of convertible preferred stock

   warrants

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

169

 

 

 

 

 

 

169

 

Issuance of common stock in exchange for

   services

 

 

 

 

 

 

 

 

 

500

 

 

 

 

 

 

3

 

 

 

 

 

 

3

 

Issuance of common stock upon exercise of

   stock options

 

 

 

 

 

 

 

 

 

56,645

 

 

 

 

 

 

64

 

 

 

 

 

 

64

 

Vesting of early exercised stock options

 

 

 

 

 

 

 

 

 

12,981

 

 

 

 

 

 

9

 

 

 

 

 

 

9

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

792

 

 

 

 

 

 

792

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(13,945

)

 

 

(13,945

)

Balance at March 31, 2021

 

 

 

 

$

-

 

 

 

 

38,769,703

 

 

$

4

 

 

$

413,286

 

 

$

(113,091

)

 

$

300,199

 

Issuance costs related to initial public offering

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(46

)

 

 

 

 

 

(46

)

Issuance of common stock upon exercise of

   stock options

 

 

 

 

 

 

 

 

 

54,561

 

 

 

 

 

 

62

 

 

 

 

 

 

62

 

Vesting of early exercised stock options

 

 

 

 

 

 

 

 

 

10,803

 

 

 

 

 

 

9

 

 

 

 

 

 

9

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,203

 

 

 

 

 

 

1,203

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(18,999

)

 

 

(18,999

)

Balance at June 30, 2021

 

 

 

 

$

-

 

 

 

 

38,835,067

 

 

$

4

 

 

$

414,514

 

 

$

(132,090

)

 

$

282,428

 

4


 

 

 

 

 

Convertible

Preferred Stock

 

 

 

Common Stock

 

 

Additional

Paid-in

 

 

Accumulated

 

 

Total

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Deficit

 

Balance at December 31, 2019

 

 

58,145,867

 

 

$

43,740

 

 

 

 

1,351,380

 

 

$

 

 

$

483

 

 

$

(37,451

)

 

$

(36,968

)

Issuance of Series C convertible preferred

   stock for cash, net of issuance costs of $62

 

 

28,063,500

 

 

 

28,001

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vesting of common shares issued to founders

 

 

 

 

 

 

 

 

 

18,281

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock upon exercise of

   stock options

 

 

 

 

 

 

 

 

 

23,750

 

 

 

 

 

 

12

 

 

 

 

 

 

12

 

Vesting of early exercised stock options

 

 

 

 

 

 

 

 

 

8,800

 

 

 

 

 

 

3

 

 

 

 

 

 

3

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

147

 

 

 

 

 

 

147

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(13,128

)

 

 

(13,128

)

Balance at March 31, 2020

 

 

86,209,367

 

 

$

71,741

 

 

 

 

1,402,211

 

 

$

-

 

 

$

645

 

 

$

(50,579

)

 

$

(49,934

)

Issuance of Series C convertible preferred stock

   upon release of escrow of acquisition-related

   contingent consideration

 

 

3,500,000

 

 

 

3,500

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of Series C convertible preferred stock

   for deferred purchase price

 

 

5,000,000

 

 

 

5,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Series C convertible preferred stock issuance

   costs

 

 

 

 

 

(12

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vesting of common shares issued to founders

 

 

 

 

 

 

 

 

 

18,281

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock upon exercise of

   stock options

 

 

 

 

 

 

 

 

 

51,666

 

 

 

 

 

 

48

 

 

 

 

 

 

48

 

Vesting of early exercised stock options

 

 

 

 

 

 

 

 

 

8,609

 

 

 

 

 

 

3

 

 

 

 

 

 

3

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

164

 

 

 

 

 

 

164

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(8,440

)

 

 

(8,440

)

Balance at June 30, 2020

 

 

94,709,367

 

 

$

80,229

 

 

 

 

1,480,767

 

 

$

-

 

 

$

860

 

 

$

(59,019

)

 

$

(58,159

)

 

See accompanying notes.

 

 

5


 

PROMETHEUS BIOSCIENCES, INC.

Unaudited Condensed Consolidated Statements of Cash Flows

(in thousands)

 

 

 

Six Months Ended

June 30,

 

 

 

2021

 

 

2020

 

Cash flows from operating activities

 

 

 

 

 

 

 

 

Net loss

 

$

(32,944

)

 

$

(21,568

)

Loss from continuing operations

 

 

(32,944

)

 

 

(14,105

)

Loss from discontinued operations, net of income taxes

 

 

 

 

 

(7,463

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

95

 

 

 

49

 

Stock-based compensation expenses

 

 

1,995

 

 

 

264

 

Change in fair value of preferred stock purchase right liability

 

 

980

 

 

 

 

Change in fair value of preferred stock warrant liability

 

 

105

 

 

 

3

 

Common stock issued in exchange for services

 

 

3

 

 

 

 

Noncash interest expense

 

 

540

 

 

 

865

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable

 

 

869

 

 

 

(178

)

Prepaid expenses and other current assets

 

 

(4,815

)

 

 

(1,022

)

Other assets

 

 

(468

)

 

 

213

 

Accounts payable

 

 

1,143

 

 

 

(442

)

Accrued compensation

 

 

(325

)

 

 

191

 

Accrued expenses and other current liabilities

 

 

114

 

 

 

399

 

Payments made to PLI

 

 

 

 

 

(2,067

)

Payable to PLI

 

 

(897

)

 

 

 

Deferred revenue

 

 

9,254

 

 

 

253

 

Net cash used in operating activities – continuing operations

 

 

(24,351

)

 

 

(15,577

)

Net cash used in operating activities – discontinued operations

 

 

 

 

 

(2,584

)

Net cash used in operating activities

 

 

(24,351

)

 

 

(18,161

)

Cash flows from investing activities

 

 

 

 

 

 

 

 

Purchase of property and equipment

 

 

(580

)

 

 

(186

)

Net cash used in investing activities – continuing operations

 

 

(580

)

 

 

(186

)

Net cash used in investing activities – discontinued operations

 

 

 

 

 

(942

)

Net cash used in investing activities

 

 

(580

)

 

 

(1,128

)

Cash flows from financing activities

 

 

 

 

 

 

 

 

Proceeds from issuance of convertible preferred stock, net of issuance costs

 

 

73,749

 

 

 

27,991

 

Proceeds from issuance of long-term debt, net of issuance costs

 

 

 

 

 

7,338

 

Proceeds from sale of common stock in initial public offering

 

 

218,500

 

 

 

 

Payment of financing costs

 

 

(17,256

)

 

 

 

Proceeds from issuance of common stock upon stock option exercises

 

 

126

 

 

 

57

 

Net cash provided by financing activities

 

 

275,119

 

 

 

35,386

 

Net increase in cash and cash equivalents

 

 

250,188

 

 

 

16,097

 

Cash and cash equivalents at beginning of period – continuing operations

 

 

54,201

 

 

 

4,450

 

Cash and cash equivalents at beginning of period – discontinued operations

 

 

 

 

 

3,921

 

Cash and cash equivalents cash at end of period

 

 

304,389

 

 

 

24,468

 

Cash and cash equivalents at end of period – discontinued operations

 

 

 

 

 

394

 

Cash and cash equivalents at end of period – continuing operations

 

$

304,389

 

 

$

24,074

 

Supplemental schedule of non-cash investing and financing activities

 

 

 

 

 

 

 

 

Conversion of convertible preferred stock into common stock upon completion of

   initial public offering

 

$

210,810

 

 

$

 

Reclassification of preferred stock purchase right liability to equity due to issuance of

   Series D convertible preferred stock

 

$

4,880

 

 

$

 

Reclassification of warrant liability to equity due to conversion from preferred stock

   warrant to common stock warrant upon completion of initial public offering

 

$

169

 

 

$

 

Issuance of Series D-2 convertible preferred stock for the settlement of deferred purchase price

 

$

6,144

 

 

$

 

Acquisition-related consideration held in escrow

 

$

 

 

$

(3,500

)

Issuance of Series C convertible preferred stock for deferred purchase price

 

$

 

 

$

5,000

 

Vesting of unvested issued common stock

 

$

18

 

 

$

6

 

Financing costs incurred, but not paid, included in accrued expenses and accounts payable

 

$

 

 

$

2

 

Costs incurred, but not paid, in connection with capital expenditures included in accounts payable

 

$

208

 

 

$

6

 

 

See accompanying notes.

 

6

 


 

PROMETHEUS BIOSCIENCES, INC.

Notes to Unaudited Condensed Consolidated Financial Statements

1.

Organization

Prometheus Biosciences, Inc. (the Company) was incorporated in the state of Delaware on October 26, 2016 under the name Precision IBD, Inc. and is headquartered in San Diego, California. The Company changed its name to Prometheus Biosciences, Inc. on October 1, 2019. The Company’s business is focused on the discovery, development and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases, starting first with inflammatory bowel disease (IBD).

In June 2019, the Company acquired Prometheus Laboratories, Inc. (PLI) and the related intangible assets used by PLI. PLI was wholly owned by Nestlé Health Science US Holdings, Inc. and the related intangible assets were owned by Societé Des Produits Nestlé S.A (together, Nestlé) (see Note 6). PLI markets and conducts several laboratory developed tests useful to gastroenterologists in monitoring their IBD patients’ disease state and informing their therapeutic decisions.

On December 31, 2020, the Company completed the spinoff of PLI by making an in-kind distribution of 100% of its interest in PLI to the Company’s stockholders of record on December 30, 2020 (see Note 6).

Reverse Stock Split

On March 5, 2021, the Company effected a one-for-ten reverse stock split of the Company’s common stock (the Reverse Stock Split). The par value and the authorized shares of the common stock were not adjusted as a result of the Reverse Stock Split. All issued and outstanding common stock and the conversion prices and ratio of the convertible preferred stock have been retroactively adjusted to reflect this Reverse Stock Split for all periods presented.

Initial Public Offering

On March 16, 2021, the Company completed its initial public offering (IPO) with the sale of 11,500,000 shares of common stock, which included the exercise in full by the underwriters of their option to purchase 1,500,000 additional shares, at an initial public offering price of $19.00 per share and received gross proceeds of $218.5 million, which resulted in net proceeds to the Company of approximately $199.8 million, after deducting underwriting discounts and commissions of approximately $15.3 million and offering-related transaction costs of approximately $3.4 million.

In addition, in connection with the completion of the IPO, all outstanding shares of convertible preferred stock were converted into 25,485,955 shares of the Company’s common stock; outstanding warrants to purchase 148,848 shares of convertible preferred stock were converted into warrants to purchase 14,884 shares of the Company’s common stock; and the Company’s certificate of incorporation was amended and restated to authorize 400,000,000 shares of common stock and 40,000,000 shares of undesignated preferred stock.

Liquidity

The Company has incurred net losses since inception, experienced negative cash flows from operations, and as of June 30, 2021, has an accumulated deficit of $132.1 million. The Company has historically financed its operations primarily through private placements of convertible preferred stock. The Company expects operating losses and negative cash flows from operations to continue for the foreseeable future. The Company believes its current capital resources will be sufficient for the Company to continue as a going concern for at least one year from the issuance date of these condensed consolidated financial statements.

The Company will be required to raise additional capital, however, there can be no assurance as to whether additional financing will be available on terms acceptable to the Company, if at all. If sufficient funds on acceptable terms are not available when needed, it would have a negative impact on the Company’s financial condition and could force the Company to delay, limit, reduce, or terminate product development or future commercialization efforts or grant rights to develop and market product candidates or testing products that the Company would otherwise plan to develop.

2.

Summary of Significant Accounting Policies

Basis of Presentation and Use of Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States (GAAP) requires management to make estimates and assumptions that impact the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities in the Company’s condensed consolidated financial statements and

7

 


 

accompanying notes. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may materially differ from these estimates and assumptions.

On December 31, 2020, the Company completed the spinoff of PLI. The results of operations for the three and six months ended June 30, 2020 have been presented as discontinued operations in the accompanying condensed consolidated financial statements in accordance with Accounting Standards Codification (ASC) 205-20, Presentation of Financial Statements—Discontinued Operations. Unless otherwise noted, discussion within these notes to the condensed consolidated financial statements relates to continuing operations (see Note 6 for additional information on discontinued operations).

On an ongoing basis, management evaluates its estimates, primarily related to revenue recognition, stock-based compensation, accrued research and development costs, and for periods prior to its IPO, the fair value of common stock, the fair value of the convertible preferred stock, and the fair value of the preferred stock purchase right liability. These estimates are based on historical data and experience, as well as various other factors that management believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Estimates relating to the valuation of stock require the selection of appropriate valuation methodologies and models, and significant judgment in evaluating ranges of assumptions and financial inputs.

Unaudited Interim Financial Information

The unaudited financial statements at June 30, 2021, and for the three and six months ended June 30, 2021 and 2020, have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (SEC), and with GAAP applicable to interim financial statements. These unaudited financial statements have been prepared on the same basis as the audited financial statements and include all adjustments, consisting of only normal recurring accruals, which in the opinion of management are necessary to present fairly the Company’s financial position as of the interim date and results of operations for the interim periods presented. Interim results are not necessarily indicative of results for a full year or future periods. The preparation of financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ materially from those estimates. These unaudited financial statements should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2020, included in the Prospectus dated March 11, 2021 filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, with the SEC on March 12, 2021.

Principles of Consolidation

The condensed consolidated financial statements include the accounts of the Company and until December 31, 2020, the date at which the spinoff was completed, its wholly-owned subsidiary, PLI, and have been prepared in conformity with GAAP. All intercompany accounts and transactions have been eliminated in consolidation.

Segment Reporting

The Company’s Chief Executive Officer, who is considered to be the chief operating decision maker (CODM), reviews financial information presented on a consolidated basis, accompanied by information about operating segments for purposes of making operating decisions and assessing financial performance. Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated regularly by the CODM in deciding how to allocate resources and in assessing performance.

Prior to the spinoff of PLI in December 2020, the Company determined its operating segments to be the therapeutics and diagnostic services businesses. The therapeutics business derives substantially all of its revenue from collaboration agreements and devotes all of its efforts to development of product candidates and companion diagnostics in the IBD space. The diagnostic services business, which is recorded as discontinued operations, derived its revenue from diagnostic services in the IBD space generated from the conduct of laboratory developed tests. Since the spinoff, the Company has operated solely within the therapeutics segment. The Company operates solely in the United States.

Cash and Cash Equivalents

The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. The cash and cash equivalents balance at June 30, 2021 and December 31, 2020 represents cash in readily available checking and money market accounts.

8


 

Concentration of Credit Risk

Financial instruments, which potentially subject the Company to concentration of credit risk, consist primarily of cash, cash equivalents, and accounts receivable. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. Management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held.

Deferred Financing Costs

At December 31, 2020, financing costs, consisting of legal, accounting, printer and filing fees related to the Company’s IPO, totaled $1.7 million.  Upon the completion of the IPO in March 2021, all of these expenses were offset against the proceeds from the IPO.

Revenue Recognition

The Company recognizes revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers (ASC 606). In accordance with ASC 606, the Company performs the following steps in determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of these agreements: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when, or as, the Company satisfies each performance obligation. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

To date, all of the Company’s collaboration revenue has been derived from its collaboration agreement with Millennium Pharmaceuticals, Inc., a subsidiary of Takeda Pharmaceutical Company Limited (collectively, Takeda) and its collaboration agreement with Dr. Falk Pharma GmbH as described in Note 5. The terms of these arrangements include the following types of payments to the Company: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; payments for research and development services provided by the Company; and royalties on net sales of licensed products. At the initiation of an agreement, the Company analyzes whether each unit of account results in a contract with a customer under ASC 606 or in an arrangement with a collaborator subject to guidance under ASC 808, Collaborative Arrangements (ASC 808).

The Company considers a variety of factors in determining the appropriate estimates and assumptions under these arrangements, such as whether the elements are distinct performance obligations, whether there are observable stand-alone prices, and whether any licenses are functional or symbolic. The Company evaluates each performance obligation to determine if it can be satisfied and recognized as revenue at a point in time or over time. Typically, license fees, non-refundable upfront fees, and funding of research activities are considered fixed, while milestone payments are identified as variable consideration which must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price. The Company estimates the amount of variable consideration using the most likely amount, as milestone payments typically only have two possible outcomes. The Company recognizes revenue for sales-based royalty promised in exchange for the license of intellectual property only when the subsequent sale occurs.

The Company may allocate transaction price using a number of methods including estimating standalone selling price of performance obligations and using the residual approach when the standalone selling price of the license is highly variable or uncertain, and observable standalone selling prices exist for the other goods or services promised in the contract.

The Company receives payments from its collaborators based on terms established in each contract. Upfront payments and other payments may require deferral of revenue recognition to a future period until the Company is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the payment by the customer is akin to a deposit for research and development services.

Research and Development and Clinical Trial Accruals

Research and development costs are charged to expense as incurred. Research and development expenses include certain payroll and personnel expenses, laboratory supplies, consulting costs, external contract research and development expenses, and allocated overhead, including rent, equipment depreciation and utilities. Advance payments for goods or services for future research and development activities are deferred and expensed as the goods are delivered or the related services are performed.

9


 

The Company estimates preclinical studies and clinical trial expenses based on the services performed pursuant to contracts with research institutions and clinical research organizations that conduct and manage preclinical studies and clinical trials on the Company’s behalf. In addition, clinical study and trial materials are manufactured by contract manufacturing organizations. In accruing for these services, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. These estimates are based on communications with the third-party service providers and the Company’s estimates of accrued expenses and on information available at each balance sheet date. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly.

Fair Value Measurements

Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability.

Stock-Based Compensation

The Company expenses stock-based compensation to employees and non-employees over the requisite service period (usually the vesting period) on a straight-line basis, net of actual forfeitures during the period, based on the estimated grant-date fair value of the awards. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model, and the assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment.

Valuation of Common Stock

Prior to the IPO, given the absence of a public trading market for the Company’s common stock, its board of directors exercised their judgment and considered a number of objective and subjective factors to determine the best estimate of the fair value of the Company’s common stock, such as: contemporaneous valuations performed by independent third-party specialists, its stage of development, including the status of its research and development efforts of its product candidates, the material risks related to its businesses and industry, its results of operations before discontinued operations and financial position, including its levels of capital resources, the prices at which its sold shares of its convertible preferred stock, the rights, preferences and privileges of its convertible preferred stock relative to those of its common stock, the conditions in the biotechnology industry and the economy in general, the stock price performance and volatility of comparable life sciences public companies, as well as recently completed mergers and acquisitions of peer companies, the likelihood of achieving a liquidity event for the holders of its common stock or convertible preferred stock, such as an IPO or a sale of the Company given prevailing market conditions, trends and developments in its industry, external market conditions affecting the life sciences and biotechnology sectors, and the lack of liquidity of its common stock, among other factors.

After the completion of the IPO, the fair value of each share of common stock is based on the closing price of the Company’s common stock as reported by Nasdaq.

Preferred Stock Purchase Right Liabilities

From time to time, the Company enters into convertible preferred stock financings where, in addition to the initial closing, investors agree to buy, and the Company agrees to sell, additional shares of that convertible preferred stock at a fixed price in the event that certain conditions are met or agreed upon milestones are achieved. The Company evaluates this purchase right and assesses whether it meets the definition of a freestanding instrument and, if so, determines the fair value of the purchase right liability and records it on the balance sheet with the remainder of the proceeds raised allocated to convertible preferred stock. The preferred stock purchase right liability is revalued at each reporting period with changes in the fair value of the liability recorded as change in fair value of preferred stock purchase right liability in the statements of operations. Upon the issuance of the shares of Series D-2 convertible preferred stock in January 2021, the preferred stock purchase right liability no longer required liability accounting and the then fair value of the preferred stock purchase right liability was reclassified into stockholders’ equity.

The Company performed the final remeasurement of the preferred stock purchase right liability as of the issuance of the shares of Series D-2 convertible preferred stock and recorded a $1.0 million change in fair value into other income (expense) for the six months ended June 30, 2021.

10


 

Net Loss Per Share

Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common stock equivalents outstanding for the period determined using the treasury-stock method. The Company has excluded 35,369 and 41,654 weighted-average shares subject to repurchase or forfeiture from the weighted-average number of common shares outstanding for the three and six months ended June 30, 2021, respectively, and 185,333 and 200,027 weighted-average shares subject to repurchase or forfeiture from the weighted-average number of common shares outstanding for the three and six months ended June 30, 2020, respectively. Dilutive common stock equivalents are comprised of convertible preferred stock and options outstanding under the Company’s stock option plan.

Basic and diluted net loss attributable to common holders per share is presented in conformity with the two- class method required for participating securities as the convertible preferred stock are considered participating securities. The Company’s participating securities do not have a contractual obligation to share in the Company’s losses. As such, the net loss was attributed entirely to common stockholders. Accordingly, for three and six months ended June 30, 2021 and 2020, there is no difference in the number of shares used to calculate basic and diluted shares outstanding.

Potentially dilutive securities not included in the calculation of diluted net loss per share because to do so would be anti-dilutive are as follows (in common stock equivalent shares):

 

 

 

June 30,

 

 

 

2021

 

 

2020

 

Convertible preferred stock outstanding

 

 

 

 

 

9,470,926

 

Common stock options issued and outstanding

 

 

5,190,989

 

 

 

1,538,211

 

Warrants to purchase common stock

 

 

14,884

 

 

 

 

Warrants to purchase convertible preferred stock outstanding

 

 

 

 

 

11,250

 

ESPP shares pending issuance

 

 

12,536

 

 

 

 

Total

 

 

5,218,409

 

 

 

11,020,387

 

Recent Accounting Standards

From time to time, new accounting standards are issued by the Financial Accounting Standards Board (FASB) or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s financial position or results of operations upon adoption.

In April 2012, the Jump-Start Our Business Startups Act (the JOBS Act) was signed into law. The JOBS Act contains provisions that, among other things, reduce certain reporting requirements for an emerging growth company. As an emerging growth company, the Company may elect to adopt new or revised accounting standards when they become effective for non-public companies, which typically is later than when public companies must adopt the standards. The Company has elected to take advantage of the extended transition period afforded by the JOBS Act and, as a result, will comply with new or revised accounting standards on the relevant dates on which adoption of such standards is required for emerging growth companies, which are the dates included below.

Adoption of New Accounting Standards

 

In February 2016, the FASB issued Accounting Standards Update (ASU) 2016-02, Leases (Topic 842), which supersedes FASB ASC Topic 840, Leases (Topic 840), and provides principles for the recognition, measurement, presentation and disclosure of leases for both lessees and lessors. The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method for finance leases or on a straight-line basis over the term of the lease for operating leases. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than 12 months regardless of classification. The Company early adopted this standard on January 1, 2021 by applying the modified retrospective approach (see Note 9).  The Company made accounting policy elections to exclude leases with terms of 12 months or less from the recognition requirements and to not separate lease and non-lease components.

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses: Measurement of credit Losses on Financial Instruments (ASU 2016-13), which amends the impairment model by requiring entities to use a forward looking approach

11


 

based on expected losses to estimate credit losses on certain types of financial instruments, including trade receivables and available-for sale debt securities. The Company early adopted this standard on January 1, 2021 by applying the modified retrospective approach and determined there was no cumulative-effect transition adjustment required to the opening balance of accumulated deficit for the recognition of additional credit losses upon adoption of this standard based on its outstanding accounts receivable, the composition and credit quality of its short-term investments, and current economic conditions as of that date.

In August 2020, the FASB issued ASU No. 2020-06, Debt – Debt with Conversion and Other options (Subtopic 470-20) and Derivative and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40). The amendments in this ASU reduce the number of accounting models for convertible debt instruments and convertible preferred stock, as well as, amend the guidance for the derivatives scope exception for contracts in an entity’s own equity to reduce form-over-substance-based accounting conclusion. In addition, this ASU improves and amends the related EPS guidance. The amendments in this ASU are effective for the Company on January 1, 2024, including interim periods within those fiscal years. The Company early adopted this standard on January 1, 2021 by applying the modified retrospective approach.  The adoption of ASU 2020-06 had no material impact on the Company’s condensed financial statements and accompanying footnotes.

3.

Fair Value Measurements and Fair Value of Financial Instruments

The accounting guidance defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:

 

 

 

 

Level 1

 

Quoted prices in active markets for identical assets or liabilities.

 

 

Level 2

 

Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

 

 

Level 3

 

Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

 

Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability.

The carrying amounts of cash and cash equivalents, prepaid and other assets, accounts payable and accrued liabilities are considered to be representative of their respective fair values because of the short-term nature of those instruments. Based on the borrowing rates currently available to the Company for loans with similar terms, which is considered a Level 2 input, the Company believes that the fair value of long-term debt approximates its carrying value.

The Company’s financial instruments that are carried at fair value consist of Level 3 liabilities. There were no transfers within the hierarchy during the three and six months ended June 30, 2021 and 2020. At December 31, 2020, Level 3 liabilities that were measured at fair value on a recurring basis consisted of warrants to purchase shares of convertible preferred stock and a preferred stock purchase right liability. The Company had no Level 3 liabilities at June 30, 2021 as the liabilities for the warrants to purchase shares of convertible preferred stock and the preferred stock purchase right was remeasured and reclassified to stockholders’ equity upon the closing of the Company’s IPO in March 2021 and the issuance of shares of Series D-2 convertible preferred stock in January 2021, respectively.

Convertible Preferred Stock Warrant Liability

The convertible preferred stock warrant liability was recorded at fair value utilizing the Black-Scholes option pricing model using significant unobservable inputs consistent with the inputs used for the Company’s stock-based compensation expense adjusted for the preferred stock warrants’ expected term and the fair value of the underlying preferred stock.

12


 

The assumptions used in the Black-Scholes option pricing model to determine the fair value of the convertible preferred stock warrant liability at the date of the IPO and December 31, 2020 were as follows:

 

 

 

IPO Date

 

 

December 31,

2020

 

Fair value of underlying preferred stock

 

$

1.90

 

 

$

0.83

 

Risk-free interest rate

 

 

1.70

%

 

 

1.70

%

Expected volatility

 

 

70.00

%

 

 

70.00

%

Expected term (in years)

 

 

9.0

 

 

 

9.2

 

Expected dividend yield

 

—%

 

 

—%

 

 

Preferred Stock Purchase Right Liability

At December 31, 2020, the preferred stock purchase right liability was determined using a valuation model that considered: (i) the risk-free rate commensurate with the expected milestone timing of 0.09%; (ii) the probability of the Series D-2 tranche of 80.0%; (iii) volatility of 80.0%; (iv) consideration received for the Series D-1 preferred stock; (v) the number of shares to be issued to satisfy the preferred stock purchase right and at what price; and (vi) certain implied and provided assumptions needed to calibrate the Series D-1 value and the Series D-2 purchase right. Upon the issuance of the shares of Series D-2 convertible preferred stock in January 2021, the liability was remeasured and as a result of closing the sale of shares of Series D-2 convertible preferred stock, a charge of $1.0 million was recorded in the statement of operations for the six months ended June 30, 2021.  

Activity of Liabilities Using Fair Value Level 3 Measurements

The following table summarizes the activity of the financial instruments valued using Level 3 inputs (in thousands):

 

 

 

Convertible

Preferred

Stock Warrant

Liability

 

 

Series D

Convertible

Preferred

Stock Purchase

Right Liability

 

Balance at December 31, 2020

 

$

64

 

 

$

3,900

 

Change in fair value

 

 

105

 

 

 

980

 

Conversion/Settlement during 2021

 

 

(169

)

 

 

(4,880

)

Balance at June 30, 2021

 

$

 

 

$

 

 

4.

Balance Sheet Details

Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consist of the following (in thousands):

 

 

 

June 30,

2021

 

 

December 31,

2020

 

Prepaid research and development

 

 

4,806

 

 

 

1,894

 

Other prepaid expenses

 

 

2,177

 

 

 

275

 

Total

 

$

6,983

 

 

$

2,169

 

 

Equipment, Net

Equipment, net, consist of the following (in thousands):

 

 

 

June 30,

2021

 

 

December 31,

2020

 

Laboratory equipment

 

$

1,329

 

 

$

572

 

Office equipment and furniture

 

 

24

 

 

 

24

 

 

 

 

1,353

 

 

 

596

 

Less accumulated depreciation

 

 

(244

)

 

 

(149

)

Total

 

$

1,109

 

 

$

447

 

 

13


 

 

Depreciation expense related to property and equipment was $0.1 million and $27,000 for the three months ended June 30, 2021 and 2020, respectively, and $0.1 million and $49,000 for the six months ended June 30, 2021 and 2020, respectively.

    

Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consist of the following (in thousands):

 

 

 

June 30,

 

 

December 31,

 

 

 

2021

 

 

2020

 

Accrued research and development

 

$

2,076

 

 

$

1,940

 

Accrued legal expenses

 

 

188

 

 

 

490

 

Unvested early exercise liability

 

 

49

 

 

 

67

 

Accrued other

 

 

422

 

 

 

397

 

Total

 

$

2,735

 

 

$

2,894

 

 

5.

Collaboration and License Agreements

Cedars-Sinai Medical Center

In September 2017, the Company entered into an Exclusive License Agreement with Cedars-Sinai Medical Center (Cedars-Sinai), a related party, as amended and restated (the Cedars-Sinai Agreement). Under the terms of the Cedars-Sinai Agreement, Cedars-Sinai granted the Company an exclusive, worldwide, royalty bearing license with respect to certain patent rights, information and materials related to therapeutic targets and companion diagnostic products, in each case to conduct research, develop, and commercialize therapeutic and diagnostic products for human use. The licensed technology includes information and materials arising out of Cedars-Sinai’s database and biobank, as well as exclusive access to this database and biobank, which is an integral part of the Company’s Prometheus360 platform.  In August 2021, the Company and Cedars-Sinai amended and restated the Cedars-Sinai Agreement to, among other things, add a joint steering committee and cover new intellectual property.

As consideration for the license rights, in September 2017 the Company issued (i) 257,500 shares of fully vested common stock, and (ii) 335,000 shares of unvested restricted common stock, all of which is vested as of December 31, 2020. The fair value of all of the shares were measured at the date of issuance. Additionally, the Company is obligated to pay Cedars-Sinai low- to mid-single digit percentage royalties on net sales of products covered under the Cedars-Sinai Agreement. In 2017, the Company and Cedars-Sinai also entered into Research agreements, under which the parties can provide research services to each other at pricing specified in individual statements of work. During the three and six months ended June 30, 2021 and 2020, no services were provided under the agreements.

Collaboration Agreement with Millennium Pharmaceuticals, Inc., a subsidiary of Takeda Pharmaceutical Company Limited

In March 2019, the Company entered into a Companion Diagnostics Development and Collaboration Agreement (the Takeda Agreement) with Millennium Pharmaceuticals, Inc., a wholly-owned subsidiary of Takeda, pursuant to which the Company agreed to develop a companion diagnostic product for certain drug targets selected by Takeda, and Takeda agreed to develop and commercialize any therapeutic clinical candidates that it develops directed against any selected drug targets for the treatment of IBD (Takeda Drugs).

In consideration of the rights granted to Takeda under the Takeda Agreement, the Company received a one-time upfront payment of $1.5 million and is eligible to receive, for any targets selected by Takeda, future development and regulatory milestone payments of up to $47.9 million, commercial milestone payments of up to $25.0 million, sales milestone payments of up to $75.0 million, and low-single digit percentage royalties on net sales of all Takeda Drugs, subject to the terms and conditions set forth in the Takeda Agreement. 

At inception and through June 30, 2021, the Company has identified one performance obligation per each target for all the deliverables under the agreement since the delivered elements are not distinct within the context of the contract. Accordingly, the Company will recognize revenue for the transaction price in an amount proportional to the collaboration expenses incurred and the total estimated collaboration expenses over the four-year period over which it expects to satisfy its performance obligations. The Company included one milestone in the transaction price as it was deemed not probable of significant reversal at the inception of the agreement. Due to the uncertainty in the achievement of the developmental and commercial milestones, the variable consideration associated with these future milestone payments has been fully constrained (excluded) from the transaction price until such time that the Company concludes that it is probable that a significant reversal of previously recognized revenue will not occur. These estimates will be re-assessed at each reporting period. In connection with the Takeda Agreement, the Company recognized revenue of $0.1 million and $0.2 million for the three months ended June 30, 2021 and 2020, respectively, and $0.3 million and $0.4 million for the six months ended June 30, 2021 and 2020, respectively, and had deferred revenue of $1.3 million, $1.7 million as of June 30, 2021 and December 31, 2020, respectively. The Company expects to recognize $0.3 million of the deferred revenue balance during the remainder of 2021.

14


 

 

Dr. Falk Pharma GmbH Collaboration Agreement

In July 2020, the Company entered into a Co-Development and Manufacturing Agreement (the Falk Agreement) with Dr. Falk Pharma GMBH (Falk), pursuant to which the parties agreed to co-develop and commercialize, exclusively in their respective territories, therapeutic product candidates targeting members of the TNF super family for the treatment of UC and CD under the Company’s PR600 program. Under the Falk Agreement, the Company is responsible for regulatory approvals and commercialization of any products in the United States and the rest of the world, other than the Falk territory. Falk is responsible for regulatory approvals and commercialization of any products in the European Union, United Kingdom, Switzerland, the countries of the European Economic Area (excluding Malta and the Republic of Cyprus), Australia and New Zealand (Falk territory).

In consideration of the rights granted to Falk under the Falk Agreement, the Company received a one-time upfront payment of $2.5 million upon execution of the Falk Agreement in July 2020, and has received two subsequent pre-clinical development milestone payments of $2.5 million and $10.0 million. The first development milestone payment was paid when the underlying development plan was finalized in December 2020. The second development milestone payment was paid upon selection of a clinical candidate for the Company’s PR600 program in June 2021.  The Company remains eligible to receive an additional pre-clinical development milestone payment of $5.0 million and low-single to low-double digit percentage royalties on net sales of all products incorporating antibodies covered by the agreement in the Falk territory, subject to the terms of the Falk Agreement. The Company agreed to pay Falk a low-single digit royalty on net sales for such products in the Company’s territory. Falk agreed to fund 25% of the Company’s third-party development costs set forth in the development plan. 

 

At inception and through June 30, 2021, the Company has identified one performance obligation for all the deliverables under the Falk Agreement. Accordingly, the Company is recognizing revenue for the transaction price allocated to the performance obligation in an amount proportional to the collaboration expenses incurred and the total estimated collaboration expenses over the seven year period over which it expects to satisfy its performance obligation. The Company included the upfront payment and all milestone payments in the transaction price as it was deemed not probable of significant reversal at the inception of the agreement. In connection with the Falk Agreement, the Company recognized revenue of $0.3 million and $0.8 million for the three and six months ended June 30, 2021, respectively, and had deferred revenue of $14.4 million and $4.8 million as of June 30, 2021 and December 31, 2020, respectively. This deferred revenue balance is expected to be recognized proportionally as expenses are incurred over the estimated seven-year term. The Company expects to recognize $0.7 million of the deferred revenue balance during the remainder of 2021.

A reconciliation of deferred revenue related to the Takeda Agreement and the Falk Agreement for the six months ended June 30, 2021 is as follows (in thousands):

 

 

 

Takeda

Agreement

 

 

Falk

Agreement

 

 

Total

 

Balance at December 31, 2020

 

$

1,710

 

 

$

4,763

 

 

$

6,473

 

Amounts received in 2021

 

 

(150

)

 

 

10,489

 

 

 

10,339

 

Revenue recognized in 2021

 

 

(267

)

 

 

(819

)

 

 

(1,086

)

Balance at June 30, 2021

 

$

1,293

 

 

$

14,433

 

 

$

15,726

 

 

6.

Discontinued Operations

On June 30, 2019, the Company acquired 100% of the common stock of PLI and the related intangible assets used by PLI for total consideration of approximately $31.7 million, consisting of the issuance of 16.5 million shares of the Company’s Series C convertible preferred stock with a fair value of $16.5 million, the present value of $15.0 million in deferred cash payments due as follows: $5.0 million due on June 30, 2020 and $10.0 million due on June 30, 2021, and acquisition-related contingent consideration consisting of 3,500,000 shares of the of the Company’s Series C convertible preferred stock with a fair value of $3.5 million. The deferred cash payments totaling $15.0 million were not contingent upon any event and to reflect the interest component were discounted at 12%. In June 2020, $5.0 million of deferred cash payments were converted to 5,000,000 shares of Series C convertible preferred stock and in October 2020, $3.8 million of deferred cash payments were converted to 5,088,851 shares of Series D convertible preferred stock. In addition, in January 2021, $6.1 million of deferred cash payments were converted to 7,219,560 shares of Series D-2 shares of convertible preferred stock. As of June 30, 2021 and December 31, 2020, a total of $0 and $5.7 million, respectively, is recorded as Amounts due to Nestlé, current—related party in the accompanying condensed consolidated balance sheets. The acquisition-related contingent consideration stipulated certain revenue thresholds for the Anser® test during the first calendar year following the acquisition. The shares were released from escrow on June 30, 2020.

15


 

In December 2020, in order to achieve the Company’s strategic objectives, the Company’s board of directors approved the spinoff of PLI by making an in-kind distribution of 100% of its interest in PLI to the Company’s stockholders of record on December 30, 2020.

In connection with the spinoff, which was effected on December 31, 2020, the Company assigned PLI specific intellectual property to PLI; entered into a transition services agreement whereby the Company agreed to provide PLI with certain transition services including general and administrative, finance and clinical operations support; and entered into a sublease agreement under which the Company will continue to occupy approximately 40,000 square feet in the PLI facility for a term of one year, with an option to renew for an additional year.

Post spinoff, the Company retained obligations under the Oxford Loan (see Note 7) and for the deferred cash payments to Nestlé.

The major line items constituting the loss of PLI for the three and six months ended June 30, 2020, which are reflected in the accompanying condensed consolidated statements of operations as discontinued operations, are as follows:

 

 

 

Three Months Ended June 30, 2020

 

 

Six Months Ended June 30, 2020

 

Diagnostic services revenue

 

$

7,890

 

 

$

17,940

 

Operating expenses:

 

 

 

 

 

 

 

 

Cost of diagnostic services revenue

 

 

3,127

 

 

 

6,736

 

Research and development

 

 

1,152

 

 

 

2,808

 

Sales and marketing

 

 

2,178

 

 

 

7,141

 

General and administrative

 

 

2,434

 

 

 

5,844

 

Restructuring

 

 

(12

)

 

 

2,274

 

Amortization of intangible assets

 

 

300

 

 

 

600

 

Total operating expenses

 

 

9,179

 

 

 

25,403

 

Loss from discontinued operations

 

$

(1,289

)

 

$

(7,463

)

 

Commitments and Contingencies

At the acquisition date, PLI was involved with several legal proceedings and claims against it. All claims against PLI remained obligations of PLI and effective upon the spinoff, the Company has no remaining obligations with respect to these claims.

7.

Long Term Debt

As of June 30, 2021, long-term debt, net, current portion, consists of the following (in thousands):

 

Long-term debt

 

$

7,500

 

Final payment

 

 

300

 

 

 

 

7,800

 

Less debt discount

 

 

(404

)

Long-term debt, net, current portion

 

$

7,396

 

 

In January 2020, the Company entered into a Loan and Security Agreement with Oxford Finance LLC and its affiliates (Oxford) (the Oxford Loan) which provided for total borrowings of up to $25.0 million, of which $7.5 million was drawn upon execution of the agreement. Interest accrued at an annual rate at the greater of (a) the 30-day U.S. LIBOR rate reported the last business day of the month that immediately precedes the month in which the interest will accrue, or (b) 2.01%, plus 5.98%, with a minimum annual rate of 7.99%. From March 1, 2020 through February 28, 2023, the Company was required to make interest only payments. Beginning March 1, 2023, in addition to interest payments, the monthly payments were to include an amount equal to the outstanding principal divided by 24 months. At maturity (or earlier prepayment), the Company was also required to make a final payment equal to 4.0% of the original principal amount borrowed and 3% of the future amount to be funded. At June 30, 2021, no amounts remain available for borrowing under the Oxford Loan due to the expiration of the provision that allowed for additional borrowings.

The Oxford Loan was collateralized by a first priority security interest in substantially all of the Company’s current and future assets, other than its intellectual property, and contains customary conditions of borrowing, events of default and covenants, including

16


 

covenants that restricted the Company’s ability to dispose of assets, merge with or acquire other entities, incur indebtedness and make distributions to holders of the Company’s capital stock. Should an event of default occur, including the occurrence of a material adverse change, the Company could have been liable for immediate repayment of all obligations under the Oxford Loan. In December 2020, the Oxford Loan Agreement was amended to allow the PLI spinoff and to release PLI from all obligations pursuant to the Oxford Loan.

In addition, warrants to purchase 112,500 shares of Series C convertible preferred stock were issued to Oxford in conjunction with the execution of the agreement at an exercise price of $1.00 per share. The warrants have a ten-year life and are exercisable immediately. The warrant became exercisable for an aggregate of 14,884 shares of the Company’s common stock at an exercise price of $7.558 per share upon the completion of the IPO. The fair value of the warrant, the debt issuance costs and the final payment totaling approximately $0.6 million are being amortized to interest expense using the effective interest method over the term of the debt.

On July 8, 2021, the Company voluntarily prepaid the aggregate outstanding principal balance of $7.5 million plus an additional $0.5 million consisting of the prepayment penalty and accrued interest due under the terms of the Oxford Loan, and therefore classified the Oxford Loan as a current liability as of June 30, 2021 in the consolidated condensed balance sheets.

 

 

8.

Stockholders’ Equity (Deficit)

Amended Certificate of Incorporation

In March 2021, the Company amended its Certificate of Incorporation to authorize 400,000,000 shares of common stock and 40,000,000 shares of preferred stock.

Convertible Preferred Stock

In connection with the completion of the Company’s IPO on March 16, 2021, all outstanding shares of convertible preferred stock were converted into 25,485,955 shares of the Company’s common stock and outstanding warrants to purchase 148,848 shares of convertible preferred stock were converted into warrants to purchase 14,884 shares of the Company’s common stock.

As of December 31, 2020, the Company’s convertible preferred stock was classified as temporary equity on the accompanying balance sheet in accordance with authoritative guidance for the classification and measurement of potentially redeemable securities whose redemption is based upon certain change in control events outside of the Company’s control.

Series C Convertible Preferred Stock

In March 2020, the Company sold 28,063,500 shares of Series C convertible preferred stock and received net cash proceeds totaling $28.0 million.

Series D Convertible Preferred Stock

In October 2020, the Company entered into a Series D convertible preferred stock purchase agreement (Series D SPA) under which it issued 61,066,216 shares of Series D-1 convertible preferred stock, for cash, at a price of $0.7558 per share, for net proceeds of $46.2 million (the Initial Series D Closing). In addition, 5,088,851 shares of Series D-1 convertible preferred stock were issued to Nestlé in satisfaction of a deferred purchase price obligation of $3.8 million. The Series D SPA contained provisions that potentially obligated the Company to issue an additional 94,007,051 shares of Series D-2 convertible preferred stock at $0.8510 per share in an additional closing, 7,231,311 of which was issuable to Nestlé for satisfaction of deferred purchase price obligations of $6.2 million, upon the approval by the Company’s board of directors, or at the option of the investors who participated in the Initial Series D Closing, or upon the achievement of certain milestones as defined in the Series D SPA, which purchase right terminates upon certain specified events, including an initial public offering of the Company, if any.

The Company determined its obligation to issue additional shares of the Company’s Series D-2 convertible preferred stock in the Initial Series D Closing represented a freestanding financial instrument that required liability accounting. This freestanding preferred stock purchase right liability for the additional closing was recorded at fair value, with changes in fair value recognized in the statements of operations. As of the Initial Series D Closing, the estimated fair value of the preferred stock purchase right liability was $3.9 million. In January 2021, 93,995,300 shares of Series D-2 convertible preferred stock were issued, of which, 7,219,560 were issued to Nestlé for the satisfaction of deferred purchase price obligations of $6.1 million.  Upon the closing of the sale of these shares, the preferred stock purchase right liability was remeasured to fair value and the change in fair value of $1.0 million was recorded in

17


 

the statement of operations for the three and six months ended June 30, 2021.  The liability was then reclassified to stockholders’ equity.

The authorized, issued and outstanding shares of convertible preferred stock as of December 31, 2020 consist of the following (in thousands, except share and per share amounts):

 

 

 

Shares

Authorized

 

 

Shares

Issued and

Outstanding

 

 

Per Share

Original

Issue Price

 

 

Liquidation

Value

 

 

Carrying

Value

 

Series A

 

 

14,979,200

 

 

 

14,979,200

 

 

$

0.50

 

 

$

7,490

 

 

$

7,391

 

Series B

 

 

26,666,667

 

 

 

26,666,667

 

 

 

0.75

 

 

 

20,000

 

 

 

19,901

 

Series C

 

 

53,176,000

 

 

 

53,063,500

 

 

 

1.00

 

 

 

53,064

 

 

 

52,937

 

Series D-1

 

 

66,155,067

 

 

 

66,155,067

 

 

 

0.76

 

 

 

49,933

 

 

 

45,794

 

Series D-2

 

 

94,007,051

 

 

 

 

 

 

 

 

 

 

 

 

 

Total

 

 

254,983,985

 

 

 

160,864,434

 

 

 

 

 

 

$

130,487

 

 

$

126,023

 

Equity Incentive Plans

In 2017, the Company adopted the 2017 Equity Incentive Plan (the 2017 Plan), which as amended, had 5,524,354 shares of common stock reserved for issuance. Under the 2017 Plan, the Company could grant stock options, stock appreciation rights, restricted stock, restricted stock units and other awards to individuals who are employees, non-employee directors or consultants of the Company or its subsidiaries. The maximum term of the options granted under the 2017 Plan was no more than ten years. Grants generally vested at 25% one year from the vesting commencement date and ratably each month thereafter for a period of 36 months, subject to continuous service. The 2017 Plan allowed for the early exercise of all stock options granted if authorized by the board of directors at the time of grant.

In February 2021, the board of directors adopted, and the Company’s stockholders approved, the 2021 Incentive Award Plan (the 2021 Plan), which became effective in connection with the IPO. Pursuant to the 2021 Plan, the Company ceased granting awards under the 2017 Plan. Under the 2021 Plan, the Company may grant stock options, restricted stock, dividend equivalents, restricted stock units, stock appreciation rights, and other stock or cash-based awards to individuals who are then employees, officers, non-employee directors or consultants of the Company. The number of shares initially available for issuance under awards granted pursuant to the 2021 Plan is the sum of (1) 3,600,000 shares of common stock, plus (2) any shares subject to outstanding awards under the 2017 Plan as of the effective date of the 2021 Plan that become available for issuance under the 2021 Plan thereafter in accordance with its terms. In addition, the number of shares of common stock available for issuance under the 2021 Plan will be increased annually on the first day of each fiscal year during the term of the 2021 Plan, beginning with the 2022 fiscal year, by an amount equal to the lesser of (a) 5% of the shares of common stock outstanding on the final day of the immediately preceding calendar year or (b) such smaller number of shares as determined by the Company’s board of directors. At June 30, 2021, 3,326,085 shares remain available for issuance under the 2021 Plan.

The Company’s stock option activity for the six months ended June 30, 2021 is summarized in the following table:

 

 

 

Number

 

 

Weighted-

Average

Exercise

Price

 

 

Weighted-

Average

Remaining

Contractual

Term (in Years)

 

 

Weighted-

Average

Grant Date

(Fair Value)

 

 

Aggregate

Intrinsic

Value

(in thousands)

 

Outstanding at December 31, 2020

 

 

2,930,246

 

 

$

2.90

 

 

 

9.3

 

 

 

 

 

 

$

2,290

 

Granted

 

 

2,402,370

 

 

$

8.11

 

 

 

 

 

 

$

5.93

 

 

 

 

 

Exercised

 

 

(111,206

)

 

$

1.13

 

 

 

 

 

 

 

 

 

 

 

 

 

Cancelled/forfeited

 

 

(30,421

)

 

$

2.65

 

 

 

 

 

 

 

 

 

 

 

 

 

Outstanding at June 30, 2021

 

 

5,190,989

 

 

$

5.18

 

 

 

8.7

 

 

 

 

 

 

$

95,946

 

Vested or expected to vest at June 30, 2021

 

 

5,190,989

 

 

$

5.18

 

 

 

8.7

 

 

 

 

 

 

$

95,946

 

Exercisable at June 30, 2021

 

 

750,367

 

 

$

2.25

 

 

 

6.7

 

 

 

 

 

 

$

16,669

 

 

The total intrinsic value of options exercised during the three months ended June 30, 2021 and 2020 was $1.2 million and $48,000, respectively. The total intrinsic value of options exercised during the six months ended June 30, 2021 and 2020 was $1.3 million and $0.1 million, respectively.  The total intrinsic value of options vested during the three months ended June 30, 2021

18


 

and 2020 was $2.0 million and $0.1 million, respectively.  The total intrinsic value of options vested during the six months ended June 30, 2021 and 2020 was $4.3 million and $0.1 million, respectively.

The grant date fair value of stock options was determined using the Black-Scholes option pricing model with the following assumptions:

 

 

 

Three Months Ended

June 30,

 

Six Months Ended

June 30,

 

 

2021

 

2020

 

 

2021

 

2020

Risk-free interest rate

 

1.0 – 1.1%

 

0.5%

 

 

0.6 – 1.1%

 

0.5 – 1.4%

Expected volatility

 

73.0 – 74.2%

 

68.1%

 

 

73.0 – 95.2%

 

61.5 – 68.1%

Expected term (in years)

 

5.8 – 6.1

 

6.1

 

 

5.8 – 6.1

 

6.1

Expected dividend yield

 

—%

 

—%

 

 

—%

 

—%

 

Expected Term—The expected term of options granted represents the period of time that the options are expected to be outstanding. Due to the lack of historical exercise history, the expected term of the Company’s employee stock options has been determined utilizing the simplified method for awards that qualify as plain-vanilla options.

Expected Volatility—The estimated volatility was based on the historical volatility of the common stock of a group of publicly traded companies deemed comparable to the Company.

Risk-Free Interest Rate—The risk-free interest rate is the implied yield in effect at the time of the option grant based on U.S. Treasury securities with contract maturities similar to the expected term of the Company’s stock options.

Dividend Rate—The Company has not paid any cash dividends on common stock since inception and does not anticipate paying any dividends in the foreseeable future. Consequently, an expected dividend yield of zero was used.

Early Exercise Liability

The unvested shares of the early-exercised options are held in escrow until the stock option becomes fully vested or until the employee’s termination, whichever occurs first. The right to repurchase these shares lapses over the four-year vesting period. As of June 30, 2021 and December 31, 2020, the early exercise liability was $49,000 and $0.1 million, respectively. For accounting purposes, the early exercise of options is not considered to be a substantive exercise until the underlying awards vest.

The following table summarizes the activity of the unvested common stock issued pursuant to an early exercise of stock option awards for the six months ended June 30, 2021:

 

Unvested at beginning of period

 

 

54,703

 

Vested or cancelled during the period

 

 

(23,784

)

Unvested at end of period

 

 

30,919

 

 

Employee Stock Purchase Plan

In February 2021, the Company’s board of directors approved the 2021 Employee Stock Purchase Plan (the ESPP), which became effective upon the pricing of the Company’s IPO on March 16, 2021. The ESPP permits participants to purchase common stock through payroll deductions of up to 20% of their eligible compensation. Initially, a total of 360,000 shares of common stock was reserved for issuance under the ESPP. In addition, the number of shares of common stock available for issuance under the ESPP will be annually increased on the first day of each fiscal year during the term of the ESPP, beginning with the 2022 fiscal year, by an amount equal to the lessor of: (i) 1% of the total number of shares of common stock outstanding on December 31st of the preceding calendar year; or (ii) such other amount as the Company’s board of directors may determine. Stock compensation expense for the three and six months ended June 30, 2021 related to the ESPP was immaterial.  As of June 30, 2020, the Company has not issued any shares under the ESPP.  The Company had an outstanding liability of $0.2 million at June 30, 2021, which is included in accrued compensation on the balance sheet, for employee contributions to the ESPP for shares pending issuance at the end of the offering period.

19


 

Stock-Based Compensation Expense

The following table summarizes the components of stock-based compensation expense recognized in the accompanying statements of operations (in thousands):

 

 

 

Three Months Ended

June 30,

 

 

Six Months Ended

June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Research and development

 

$

267

 

 

$

16

 

 

$

438

 

 

$

30

 

General and administrative

 

 

936

 

 

 

134

 

 

 

1,557

 

 

 

234

 

Discontinued operations

 

 

 

 

 

14

 

 

 

 

 

 

47

 

Total stock-based compensation

 

$

1,203

 

 

$

164

 

 

$

1,995

 

 

$

311

 

 

The total unrecognized compensation cost related to unvested stock-based awards as of June 30, 2021 was $16.3 million and is expected to be recognized over a weighted average period of 3.4 years.

9.

Commitments and Contingencies

Leases

As a result of the PLI spinoff on December 31, 2020, the Company entered into a sublease agreement with PLI for approximately 40,000 square feet currently occupied in the PLI facility. The sublease agreement is for one year with an option to renew for an additional year. The monthly payment is $80,000 and total remaining payment obligations at June 30, 2021 and December 31, 2020 are $0.5 million and $1.0 million, respectively.

In March 2021, the Company executed a non-cancellable lease agreement for office and laboratory space in San Diego, California. The lease has an initial term of ten years, following the commencement date with an option to extend the lease for an additional five-year term. The lease provides for initial monthly rental payments of approximately $0.2 million with rent escalation and the Company is also responsible for certain operating expenses and taxes throughout the lease term. In addition, the Company is entitled to up to $6.3 million of tenant improvement allowance, of which the Company received $0.2 million as of June 30, 2021. The Company expects the lease to commence by the first quarter of 2022. At June 30, 2021, as the Company had not taken control of the space and the lease term had not yet commenced, no operating lease right-of-use assets or operating lease liabilities for the space has been recorded.

Litigation

From time to time, the Company may become involved in legal proceedings or be subject to claims arising in the ordinary course of its business. Regardless of outcome, legal proceedings or claims can have an adverse impact on the company because of defense and settlement costs, diversion of resources and other factors, and there can be no assurances that favorable outcomes will be obtained.

Indemnification Agreements

In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breech of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with officers and members of its board of directors that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. At June 30, 2021, no claims exist under indemnification arrangements and accordingly, no amounts have been accrued in its condensed consolidated financial statements as of June 30, 2021.

 

10.

Related Party Transactions

As discussed in Note 5, in September 2017, the Company entered into the Cedars-Sinai Agreement. As consideration for the license rights, the Company issued (i) 257,500 common stock shares at par value of $0.0001 per share, and (ii) 335,000 unvested restricted common stock shares at par value of $0.0001 per share. The parties also entered into additional license agreements as well as research agreements, under which the parties can provide research services to each other at pricing specified in the individual statements of work. During the three and six months ended June 30, 2021 and 2020, no services were provided under the research agreements.

20


 

During the three and six months ended June 30, 2021, the Company incurred compensation related expenses for one employee who is an immediate family member of a former member of the Company’s board of directors. These expenses totaled $0.2 million and $0.3 million for the three and six months ended June 30, 2021, respectively, which is included in in research and development expenses in the accompanying condensed consolidated statement of operations. During the three and six months ended June 30, 2020, the Company incurred compensation related expenses for two employees, each of whom is an immediate family member of a different former member of the Company’s board of directors. These expenses totaled $0.3 million and $0.5 million for the three and six months ended June 30, 2020, respectively, of which $0.2 million and $0.2 million are included in general and administrative expenses in the accompanying condensed consolidated statement of operations and $0.1 million and $0.3 million are included in research and development expenses, respectively.

As of December 31, 2020, the Company has a $5.7 million liability recorded within Amounts due to Nestlé, current—related party in the condensed consolidated balance sheet. As disclosed in Notes 6 and 8, this amount relates to deferred consideration for the acquisition of PLI and was satisfied with the issuance of 7,219,560 shares of Series D-2 convertible preferred stock in January 2021.

The Company has an ongoing collaboration with Regents of the University of California, where a former member of its board of directors is employed. During the three and six months ended June 30, 2021, the Company incurred $0.1 million and $0.2 million, respectively, in expense related to this collaboration that was recorded in research and development expenses in the accompanying condensed consolidated statement of operations for the three and six months ended June 30, 2021.  During the three and six months ended June 30, 2020, the Company incurred $0.1 million and $0.2 million, respectively, in expense related to this collaboration that was recorded in Loss from discontinued operations in the accompanying condensed consolidated statements of operations for the three and six months ended June 30, 2020.

As a result of the PLI spinoff on December 31, 2020, the Company entered into a transition services agreement under which it assumed a $1.1 million liability related to the payout of PLI employee bonuses for the year ended December 31, 2020. This amount is included in the amount payable to PLI in the accompanying condensed consolidated balance sheets. Additionally, pursuant to this agreement, the Company will be providing PLI certain transitional services, including general and administrative, finance and clinical operations support, and PLI is providing the Company with certain transitional services, including providing for the use of facilities under a sublease, in each case for specified monthly service fees. The initial term of the agreement is for one year, subject to earlier termination and extension thereafter. During the three and six months ended June 30, 2021, the Company paid PLI $0.7 million and $2.2 million, respectively, in accordance with the terms of this agreement.

11.

401(K) Plan

Effective January 1, 2018, the Company maintains a defined contribution 401(k) plan available to eligible employees. Employee contributions are voluntary and are determined on an individual basis, limited to the maximum amount allowable under federal tax regulations. The Company, at its discretion, may make certain contributions to the 401(k) plan. Company contributions made during the three months ended June 30, 2021 and 2020 were $0.1 million and $0, respectively.  Company contributions made during the six months ended June 30, 2021 and 2020 were $0.1 million and $46,000, respectively.

12.

COVID-19 Pandemic

The current COVID-19 pandemic, which is impacting worldwide economic activity, poses the risk that the Company or its employees, contractors, suppliers, and other partners may be prevented from conducting business activities for an indefinite period of time, including due to shutdowns that may be requested or mandated by governmental authorities. The extent to which the COVID-19 pandemic will impact the Company’s business will depend on future developments that are highly uncertain and cannot be predicted at this time.

13.  Subsequent Events

On July 8, 2021, the Company voluntarily prepaid the aggregate outstanding principal balance of $7.5 million plus an additional $0.5 million consisting of the prepayment penalty and accrued interest due under the terms of the Oxford Loan.

21


 

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

The following discussion and analysis and the unaudited interim condensed consolidated financial statements included in this Quarterly Report on Form 10-Q should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2020 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in the Prospectus dated March 11, 2021 filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended (the Securities Act), with the Securities and Exchange Commission (SEC) on March 12, 2021 (the Prospectus).

Forward-Looking Statements

This Quarterly Report on Form 10-Q (Quarterly Report) contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act). All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our future results of operations and financial position, business strategy, research and development plans, the anticipated timing, costs, design and conduct of our ongoing and planned preclinical studies and clinical trials for our product candidates, our plans to use our Prometheus360 product platform to expand our pipeline of product candidates and develop marketable products, the anticipated timing and costs of our development of companion diagnostics, the potential benefits from our collaboration arrangements with third parties and our plans to enter into additional arrangements, the timing and likelihood of regulatory filings and approvals for our product candidates and companion diagnostics, our ability to commercialize our product candidates, if approved, the impact of COVID-19 on our business, the pricing and reimbursement of our product candidates, if approved, and testing products, the potential to develop future product candidates, the timing and likelihood of success, plans and objectives of management for future operations, and future results of anticipated product development efforts, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important 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 the forward-looking statements.

In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this Quarterly Report are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this Quarterly Report and are subject to a number of risks, uncertainties and assumptions, including those described in Part II, Item 1A, “Risk Factors” of this report. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Overview

We are a clinical-stage biotechnology company pioneering a precision medicine approach to the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases, starting first with inflammatory bowel disease (IBD). We leverage our proprietary precision medicine platform, Prometheus360, which includes one of the world’s largest GI bioinformatics databases, to identify novel therapeutic targets and develop therapeutic candidates to engage those targets. In parallel, we are developing companion diagnostic tests designed to identify patients more likely to respond to our therapeutic candidates. We have a robust pipeline of therapeutic development programs for the treatment of IBD. Our goal is to revolutionize the treatment of IBD with a precision medicine approach for patients with significant unmet medical needs.

Our lead product candidate, PRA023, is an IgG1 humanized mAb that has been shown to block TL1A, a target associated with both intestinal inflammation and fibrosis that was clinically validated in a third-party Phase 2a clinical trial in UC. PRA023 has the potential to substantially improve outcomes for moderate-to-severe IBD patients predisposed to increased TL1A expression. We are developing PRA023 for the treatment of ulcerative colitis (UC) and Crohn’s disease (CD). In June 2021, we completed the dosing phase of the Phase 1a clinical trial of PRA023, a single center, double-blind, placebo-controlled study to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRA023 in normal healthy volunteers. Topline results from the Phase 1a trial of PRA023 are expected in the fourth quarter of 2021. In July 2021, we initiated a Phase 2 randomized placebo-controlled clinical trial of PRA023 in patients with moderate-to-severe UC (ARTEMIS-UC) and an open-label Phase 2a clinical trial in patients with moderate-to-severe CD (APOLLO-CD), with topline results from both of these clinical trials expected in the fourth quarter of 2022.  

22


 

We have also been considering potential additional indications for PRA023 in other immune-mediated diseases, beyond IBD, and plan to provide an update in the fourth quarter of 2021.

Our PR600 program targets a member of the TNF super family. It has been shown that blocking this target inhibits disease in multiple third-party IBD animal models. We have identified multiple genetic variants linked to patient subpopulations with a complicated course of disease and intend to leverage Prometheus360 in combination with functional assays to identify patients with these genetic variants. In June 2021, we selected a clinical candidate for PR600 and initiated investigational new drug application (IND) enabling studies. We expect to submit an IND for this clinical candidate in the third quarter of 2022. Our PR300 program targets an orphan G-protein coupled receptor (GPCR) expressed predominantly in the gastrointestinal (GI) tract that we believe has important functions underlying intestinal epithelial integrity and innate immune cell function.

In addition, we have several additional discovery programs with different mechanisms of action targeting UC and/or CD that are in the discovery stage of development. We also continue to evaluate numerous other drug targets identified through Prometheus360 for therapeutic utility for potential drug discovery development. The research and development of therapeutic product candidates and companion diagnostics comprises our therapeutics business segment.

On June 30, 2019, we acquired from Nestlé Prometheus Laboratories, Inc. (PLI), which markets and conducts several laboratory developed tests useful to gastroenterologists in monitoring their IBD patients’ disease state. Prior to our acquisition of PLI in June 2019, we had devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, developing our Prometheus360 platform, discovering and identifying potential product candidates, establishing our intellectual property portfolio and conducting research and preclinical studies, and providing other general and administrative support for these operations.

On December 31, 2020, we completed the spinoff of PLI by making an in-kind distribution of 100% of our interest in PLI to our stockholders of record on December 30, 2020. Except as specifically indicated, the discussion of our operations excludes the operations of PLI, which are reported as a discontinued operation in the accompanying condensed consolidated financial statements included elsewhere in this Quarterly Report and in the following discussion.

We do not expect to generate any revenue from therapeutic product sales until we successfully complete development and obtain regulatory approval for one or more of our therapeutic product candidates and companion diagnostics, which we expect will take a number of years and may never occur.

We have incurred operating losses in each year since inception. Our net losses, including those generated from PLI, were $29.7 million and $37.1 million for the years ended December 31, 2019 and 2020, respectively, and $19.0 million and $32.9 million for the three and six months ended June 30, 2021, respectively. As of June 30, 2021, we had an accumulated deficit of $132.1 million. We expect our expenses and operating losses will increase substantially as we conduct our ongoing and planned preclinical studies and clinical trials, continue our research and development activities, develop and validate companion diagnostics, utilize third parties to manufacture our product candidates and related raw materials, hire additional personnel, protect our intellectual property and incur additional costs associated with being a public company, including audit, legal, regulatory, and tax-related services associated with maintaining compliance with exchange listing and SEC requirements, director and officer insurance premiums, and investor relations costs. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our preclinical studies and clinical trials and our expenditures on other research and development activities, as well as the generation of any services and collaboration revenue.

From inception and to the date of our initial public offering (IPO) in March 2021, we had raised a total of $175.6 million to fund our operations from gross proceeds from the sale and issuance of convertible preferred stock and $7.5 million from proceeds under our loan and security agreement (the Loan Agreement) with Oxford Finance LLC and its affiliates (Oxford). In March 2021, we completed our IPO with the sale of 11,500,000 shares of common stock, which included the exercise in full by the underwriters of their option to purchase 1,500,000 additional shares, at an initial public offering price of $19.00 per share and received net of approximately $199.8 million.  As of June 30, 2021, we had cash and cash equivalents of $304.4 million.

If we obtain regulatory approval for any of our therapeutic product candidates and companion diagnostics, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. As we continue to advance our pipeline of diagnostic products, we expect to incur additional costs associated with conducting clinical studies to demonstrate the utility of our products and support reimbursement efforts. Accordingly, until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including potential additional collaborations, licenses and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into such other arrangements when needed would have a negative impact on our financial condition and could force us to delay, limit,

23


 

reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

COVID-19

The current COVID-19 worldwide pandemic has presented substantial public health and economic challenges and is affecting our employees, patients, physicians and other healthcare providers, communities and business operations, as well as the U.S. and global economies and financial markets. International and U.S. governmental authorities in impacted regions are taking actions in an effort to slow the spread of COVID-19, including issuing varying forms of “stay-at-home” orders, and restricting business functions outside of one’s home. While it is not possible at this time to estimate the impact that COVID-19 could have on our business in the future, particularly as we advance our product candidates to clinical development, the continued spread of COVID-19 and the measures taken by the governmental authorities could disrupt the supply chain and the manufacture or shipment of drug substances and finished drug products for our product candidates for use in our research, preclinical studies and clinical trials, delay, limit or prevent our employees and CROs from continuing research and development activities, impede our clinical trial initiation and recruitment and the ability of patients to continue in clinical trials, impede testing, monitoring, data collection and analysis and other related activities, any of which could delay our preclinical studies and clinical trials and increase our development costs, and have a material adverse effect on our business, financial condition and results of operations. The COVID-19 outbreak could also potentially affect the business of the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) or other regulatory authorities, which could result in delays in meetings related to our ongoing and planned clinical trials. The COVID-19 pandemic and mitigation measures have had and may continue to have an adverse impact on global economic conditions which could have an adverse effect on our business and financial condition, including impairing our ability to raise capital when needed. The extent to which the COVID-19 pandemic impacts our results will depend on future developments that are highly uncertain and cannot be predicted, including new information that may emerge concerning the virus and the actions to contain its impact.

License and Collaboration Agreements

Our Collaboration with Cedars-Sinai Medical Center

In September 2017, we entered into an exclusive license agreement with Cedars-Sinai Medical Center (Cedars-Sinai), as amended and restated (the Cedars-Sinai Agreement), pursuant to which Cedars-Sinai granted us an exclusive, worldwide license with respect to certain patents, information and materials related to therapeutic targets and companion diagnostic products, to conduct research, develop, and commercialize therapeutic and diagnostic products for human use. The licensed technology includes information and materials arising out of Cedars-Sinai’s database and biobank, as well as exclusive access to this database and biobank, which is an integral part of our Prometheus360 platform. As upfront consideration for the license agreement, we issued to Cedars-Sinai 257,500 shares of fully vested common stock and 335,000 shares of restricted common stock, which shares fully vested in September 2020. We are obligated to pay Cedars-Sinai low- to mid-single digit percentage royalties on net sales of therapeutic and diagnostic products covered under the agreement, including any related companion diagnostic products, subject to the terms and conditions set forth in the Cedars-Sinai Agreement.  In August 2021, we amended and restated the Cedars-Sinai Agreement to, among other things, add a joint steering committee and cover new intellectual property.

Our Collaboration with Takeda

In March 2019, we entered into a companion diagnostics development and collaboration agreement (the Takeda Agreement) with Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (Takeda). Pursuant to this agreement, we agreed to develop a companion diagnostic product for certain drug targets selected by Takeda and Takeda agreed to develop and commercialize any therapeutic clinical candidate that it develops directed against any selected drug targets for the treatment of IBD (Takeda Drugs).  The Company received a one-time upfront payment of $1.5 million and is also eligible to receive, for any targets selected by Takeda, certain contingent development and regulatory milestone payments, commercial milestone payments, sales milestone payments, and low-single digit percentage royalties on net sales of all Takeda Drugs, subject to the terms and conditions set forth in the Takeda Agreement.  

Our Collaboration with Dr. Falk Pharma

In July 2020, we entered into a co-development and manufacturing agreement (the Falk Agreement) with Dr. Falk Pharma GmbH (Falk), pursuant to which we will co-develop and commercialize, exclusively in our respective territories, therapeutic product candidates targeting members of the TNF super family for the treatment of UC and CD under our PR600 development program. We are responsible for regulatory approvals and commercialization of any products in the United States and the rest of the world, other than the Falk territory. Falk is responsible for regulatory approvals and commercialization of any products in the European Union, United Kingdom, Switzerland, the countries of the European Economic Area (excluding Malta and the Republic of Cyprus), Australia

24


 

and New Zealand (Falk territory). Under the Falk Agreement, Falk agreed to fund 25% of our third party development costs. In addition, Falk is obligated to make future development milestone payments, and a mid-single digit to low-double digit royalty on net sales of all products incorporating antibodies covered by the agreement in the Falk territory and we agreed to pay Falk a low-single digit royalty on net sales of such products in our territory, subject to the terms and conditions set forth in the Falk Agreement.  In June 2021, we received a $10.0 million milestone payment from Falk upon our selection of a clinical candidate for our PR600 program.

For additional information regarding the Cedars-Sinai Agreement, Takeda Agreement and Falk Agreement, as well as other agreements pursuant to which we in-license certain intellectual property rights, see “Business—License and Collaboration Agreements” in our Prospectus.

Components of Results of Operations

Revenue

Collaboration revenue

We currently derive all of our revenue from our collaboration agreements. For the foreseeable future, we expect to generate revenue from services performed under the Takeda Agreement and Falk Agreement. We may receive a combination of upfront payments and milestone payments under our current and/or future collaboration agreements.

We do not expect to generate any revenue from the sale of therapeutic products unless and until such time that our therapeutic product candidates and companion diagnostics have advanced through clinical development and regulatory approval, if ever. We expect that any revenue we generate, if at all, will fluctuate from quarter-to-quarter as a result of the timing and amount of payments relating to such services and milestones and the extent to which any of our therapeutic product candidates are approved and successfully commercialized. If we fail to complete preclinical and clinical development of therapeutic product candidates or obtain regulatory approval for them, our ability to generate future revenues, and our results of operations and financial position would be adversely affected.

Operating Expenses

Research and Development

Research and development expenses consist of external and internal costs associated with our research and development activities, including our discovery and research efforts, the preclinical and clinical development of our product candidates and the development and validation of our companion diagnostics. Our research and development expenses include:

 

external costs, including expenses incurred under arrangements with third parties, such as CROs, contract manufacturers, consultants and our scientific advisors; and

 

internal costs, including:

 

employee-related expenses, including salaries, benefits, and stock-based compensation; the costs of laboratory supplies and acquiring, developing and manufacturing preclinical study materials; and

 

facilities, information technology and depreciation, which include direct and allocated expenses for rent and maintenance of facilities and depreciation of equipment.

The following table summarizes our research and development expenses by product candidate for the periods indicated (in thousands):

 

 

 

Three Months Ended

June 30,

 

 

Six Months Ended

June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

PRA023

 

$

10,462

 

 

$

4,671

 

 

$

15,787

 

 

$

8,154

 

PR600

 

 

1,433

 

 

 

180

 

 

 

3,204

 

 

 

345

 

Other preclinical programs

 

 

1,659

 

 

 

72

 

 

 

2,321

 

 

 

689

 

Total research and development

 

$

13,554

 

 

$

4,923

 

 

$

21,312

 

 

$

9,188

 

 

We expect our research and development expenses to increase for the foreseeable future as we commence and continue to progress our Phase 2 clinical trials of PRA023 globally, advance PR600 into IND-enabling studies, develop companion diagnostics, and continue to advance several pre-clinical research and development programs. The process of conducting preclinical studies and

25


 

clinical trials necessary to obtain regulatory approval is costly and time consuming. We may never succeed in achieving marketing approval for any of our product candidates.

The timelines and costs with research and development activities are uncertain and can vary significantly for each product candidate and development program and are difficult to predict. We anticipate we will make determinations as to which programs to pursue and how much funding to direct to each program on an ongoing basis in response to preclinical and clinical results, regulatory developments, ongoing assessments as to each program’s commercial potential, and our ability to maintain or enter into new collaborations, to the extent we determine the resources or expertise of a collaborator would be beneficial for a given program. We will need to raise substantial additional capital in the future. In addition, we cannot forecast which development programs may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.

Our development costs may vary significantly based on factors such as:

 

the number and scope of preclinical and IND-enabling studies;

 

per patient trial costs;

 

the number of trials required for approval;

 

the number of sites included in the trials;

 

the countries in which the trials are conducted;

 

the length of time required to enroll eligible patients;

 

the number of patients that participate in the trials;

 

the number of doses that patients receive;

 

the drop-out or discontinuation rates of patients;

 

the number, costs and timing of developing companion diagnostics and scope of validation studies;

 

potential additional safety monitoring requested by regulatory agencies;

 

the duration of patient participation in the trials and follow-up;

 

the cost and timing of manufacturing our product candidates;

 

the phase of development of our product candidates; and

 

the efficacy and safety profile of our product candidates and effectiveness of our companion diagnostics.

General and Administrative

General and administrative expenses consist primarily of employee-related expenses, including salaries, benefits and stock-based compensation, for employees in our finance, accounting, legal, business development and support functions. Other general and administrative expenses include allocated facility, information technology and depreciation related costs not otherwise included in research and development expenses and professional fees for auditing, tax, intellectual property and legal services. Costs related to filing and pursuing patent applications are recognized as general and administrative expenses as incurred since recoverability of such expenditures is uncertain.

We expect our general and administrative expenses will increase for the foreseeable future to support our increased research and development activities and increased costs of operating as a public company. These increased costs will likely include increased expenses related to audit, legal, regulatory and tax services associated with maintaining compliance with exchange listing and SEC requirements, director and officer insurance premiums and investor relations costs associated with operating as a public company.

Interest and Other Income (Expense)

Interest income

Interest income consists primarily of interest earned on our cash and cash equivalents.

26


 

Interest expense

Interest expense consists of interest expense incurred in connection with our borrowings under the Loan Agreement and non-cash interest expense associated with the deferred purchase payments for PLI.

Change in fair value of preferred stock purchase liability

In connection with the issuance of our Series D convertible preferred stock in 2020, the investors agreed to buy, and we agreed to sell, additional shares of such preferred convertible stock at the original issue price upon the achievement of pre-defined milestones. These contractual obligations were required to be accounted for as liabilities and remeasured to fair value at each reporting date, with any change in the fair value reported as a component of other income (expense). In January 2021, with the issuance of the Series D-2 convertible preferred stock, this contractual obligation was settled and the preferred stock purchase right liability was remeasured to fair value on the purchase date and reclassified to permanent equity.

Change in fair value of preferred stock warrant liability

Changes in the fair value of preferred stock warrant liabilities relates to warrants for the purchase of convertible preferred stock issued in connection with our Loan Agreement. These warrants were converted into warrants for the purchase of common stock in connection with our IPO and were reclassified into stockholders’ equity.  Accordingly, no further fair value adjustments for these warrants are expected.

Loss From Discontinued Operations

On December 31, 2020, we completed the spinoff of PLI by making an in-kind distribution of 100% of our interest in PLI to our stockholders of record on December 30, 2020. The results of PLI have been classified as discontinued operations for the three and six months ended June 30, 2020.

Results of Operations

Comparison of the Three Months Ended June 30, 2021 and 2020

The following table summarizes our results of operations for the three months ended June 30, 2021 and 2020 (in thousands):

 

 

 

Three Months Ended

June 30,

 

 

 

 

 

 

 

2021

 

 

2020

 

 

Change

 

Collaboration revenue

 

$

326

 

 

$

179

 

 

$

147

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

13,554

 

 

 

4,923

 

 

 

8,631

 

General and administrative

 

 

5,618

 

 

 

1,810

 

 

 

3,808

 

Total operating expenses

 

 

19,172

 

 

 

6,733

 

 

 

12,439

 

Loss from operations

 

 

(18,846

)

 

 

(6,554

)

 

 

(12,292

)

Other income (expense), net:

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

37

 

 

 

3

 

 

 

34

 

Interest expense

 

 

(190

)

 

 

(595

)

 

 

405

 

Change in fair value of preferred stock warrant liability

 

 

 

 

 

(5

)

 

 

5

 

Total other income (expense), net

 

 

(153

)

 

 

(597

)

 

 

444

 

Loss from continuing operations

 

 

(18,999

)

 

 

(7,151

)

 

 

(11,848

)

Loss from discontinued operations

 

 

 

 

 

(1,289

)

 

 

1,289

 

Net loss

 

$

(18,999

)

 

$

(8,440

)

 

$

(10,559

)

 

Revenue

Revenue was $0.3 million for the three months ended June 30, 2021 compared to $0.2 million for the three months ended June 30, 2020 due to additional revenue generated from the Falk Agreement.

27


 

Research and Development Expenses

Research and development expenses were $13.6 million for the three months ended June 30, 2021 compared to $4.9 million for the three months ended June 30, 2020. The increase of $8.7 million for the three months ended June 30, 2021 compared to the three months ended June 30, 2020 was primarily driven by a $4.7 million increase in expenses related to the initiation of our global Phase 2 clinical trials for PRA023, $3.0 million increase in expenses related to research and development expenses for our other pre-clinical development programs and a $1.0 million increase in expenses related to personnel costs due to increased headcount to support increased development activities.

General and Administrative Expenses

General and administrative expenses were $5.6 million for the three months ended June 30, 2021 compared to $1.8 million for the three months ended June 30, 2020. The increase of $3.8 million for the three months ended June 30, 2021 compared to the three months ended June 30, 2020 was primarily driven by $2.1 million increase in expenses related to operating as a public company and $1.7 million increase in expenses related to personnel costs due to expansion of our executive team.

Other Income (Expense), Net

Interest expense

Interest expense was $0.2 million for the three months ended June 30, 2021 compared to interest expense of $0.6 million for the three months ended June 30, 2020. The decrease of $0.4 million for the three months ended June 30, 2021 compared to the three months ended June 30, 2020 was primarily related to reduction of non-cash interest expense incurred in connection with the deferred purchase price of PLI that was settled through conversion into Series D-2 preferred stock in January 2021.

Loss from discontinued operations

For the for the three months ended June 30, 2020, revenue from PLI totaled $7.9 million and total operating expenses totaled $9.2 million.

 

Comparison of the Six Months Ended June 30, 2021 and 2020

The following table summarizes our results of operations for the six months ended June 30, 2021 and 2020 (in thousands):

 

 

 

Six Months Ended

June 30,

 

 

 

 

 

 

 

2021

 

 

2020

 

 

Change

 

Collaboration revenue

 

$

1,086

 

 

$

407

 

 

$

679

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

21,312

 

 

 

9,188

 

 

 

12,124

 

General and administrative

 

 

10,840

 

 

 

4,197

 

 

 

6,643

 

Total operating expenses

 

 

32,152

 

 

 

13,385

 

 

 

18,767

 

Loss from operations

 

 

(31,066

)

 

 

(12,978

)

 

 

(18,088

)

Other income (expense), net:

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

55

 

 

 

5

 

 

 

50

 

Interest expense

 

 

(848

)

 

 

(1,129

)

 

 

281

 

Change in fair value of preferred stock purchase right liability

 

 

(980

)

 

 

 

 

 

(980

)

Change in fair value of preferred stock warrant liability

 

 

(105

)

 

 

(3

)

 

 

(102

)

Total other income (expense), net

 

 

(1,878

)

 

 

(1,127

)

 

 

(751

)

Loss from continuing operations

 

 

(32,944

)

 

 

(14,105

)

 

 

(18,839

)

Loss from discontinued operations

 

 

 

 

 

(7,463

)

 

 

7,463

 

Net loss

 

$

(32,944

)

 

$

(21,568

)

 

$

(11,376

)

 

Revenue

Revenue was $1.1 million for the six months ended June 30, 2021 compared to $0.4 million for the three months ended June 30, 2020 due to additional revenue generated from the Falk Agreement.

28


 

Research and Development Expenses

Research and development expenses were $21.3 million for the six months ended June 30, 2021 compared to $9.2 million for the six months ended June 30, 2020. The increase of $12.1 million for the six months ended June 30, 2021 compared to the six months ended June 30, 2020 was primarily driven by a $6.8 million increase in expenses related to the initiation of our global Phase 2 clinical trials for PRA023, $2.9 million increase in expenses related to research and development expenses for our other pre-clinical development programs and a $1.8 million increase in expenses related to personnel costs due to increased headcount to support increased development activities.

General and Administrative Expenses

General and administrative expenses were $10.8 million for the six months ended June 30, 2021 compared to $4.2 million for the six months ended June 30, 2020. The increase of $6.6 million for the six months ended June 30, 2021 compared to the six months ended June 30, 2020 was primarily driven by $1.7 million increase in expenses related to personnel costs due to expansion of our executive team, with the remainder due to increases in expenses related to operating as a public company, including one-time transaction costs indirectly related to our IPO of $1.8 million.

Other Income (Expense), Net

Interest expense

Interest expense was $0.8 million for the six months ended June 30, 2021 compared to interest expense of $1.0 million for the six months ended June 30, 2020. The decrease of $0.3 million for the six months ended June 30, 2021 compared to the six months ended June 30, 2020 was primarily related to reduction of non-cash interest expense incurred in connection with the deferred purchase price of PLI that was settled through conversion into Series D-2 preferred stock in January 2021.

Change in Fair Value of Convertible Preferred Stock Purchase Right Liability

The change in fair value of convertible preferred stock purchase right liability increased $1.0 million due to the increase in the fair value of the outstanding Series D-2 preferred stock purchase right liability as a result of closer time proximity to achieving different outcome scenarios and higher probabilities of occurrence. Upon the exercise of the preferred stock purchase right with the issuance of Series D-2 convertible preferred stock in January 2021, we remeasured the Series D-2 preferred stock purchase right liability to fair value and reclassified the resulting value to temporary equity on the balance sheet.

Loss from discontinued operations

For the for the six months ended June 30, 2020, revenue from PLI totaled $17.9 million and total operating expenses totaled $25.4 million.

Liquidity and Capital Resources

Sources of Liquidity

From our inception and to the date of our IPO, we received aggregate gross proceeds of $175.6 million from the sale of convertible preferred stock, $7.5 million from borrowings under our Loan Agreement with Oxford and $8.2 million from amounts received under the Takeda and Falk Agreements. In March 2021, we completed our IPO with the sale of 11,500,000 shares of common stock, which included the exercise in full by the underwriters of their option to purchase 1,500,000 additional shares, at an initial public offering price of $19.00 per share and received gross proceeds of $218.5 million, which resulted in net proceeds to us of approximately $199.8 million, after deducting underwriting discounts and commissions of approximately $15.3 million and offering-related transaction costs of approximately $3.4 million.  As of June 30, 2021, we had cash and cash equivalents of $304.4 million.

Oxford Loan and Security Agreement

In January 2020, we entered into the Loan Agreement with Oxford, which provided for total borrowings of up to $25.0 million, of which $7.5 million was drawn upon execution of the agreement. No additional amounts remain available for borrowing. Interest accrued at an annual rate equal to the sum of (I) the greater of (a) the 30-day U.S. LIBOR rate reported the last business day of the month that immediately preceded the month in which the interest will accrue, and (b) 2.01%, plus (II) 5.98%. Notwithstanding the foregoing, the annual rate was at no time to be less than 7.99%. From March 1, 2020 through February 28, 2023, we were required to make interest only payments. Beginning March 1, 2023, in addition to interest payments, the monthly payments were to include an

29


 

amount equal to the outstanding principal divided by 24 months. At maturity (or earlier prepayment), we were also required to make a final payment equal to 4.0% of the original principal amount borrowed and 3% of the future amount to be funded.

The Loan Agreement was collateralized by substantially all of our assets, excluding intellectual property, which is subject to a negative pledge. The Loan Agreement contained customary affirmative and negative covenants and events of default applicable to us. The affirmative covenants included, among others, covenants requiring us to maintain governmental approvals, deliver certain financial reports, maintain insurance coverage and protect material intellectual property. The negative covenants included, among others, restrictions on us transferring collateral, incurring additional indebtedness, engaging in mergers or acquisitions, paying cash dividends or making other distributions, making investments, creating liens, selling assets and making any payment on subordinated debt, in each case subject to certain exceptions.

On July 8, 2021, the Company voluntarily prepaid the aggregate outstanding principal balance of $7.5 million plus an additional $0.5 million consisting of the prepayment penalty and accrued interest due under the terms of the Loan Agreement.

In connection with execution of the Loan Agreement, we issued Oxford a warrant to purchase 112,500 shares of our Series C convertible preferred stock at an exercise price of $1.00 per share, exercisable at any time following issuance. The preferred stock warrant has a term of ten years. The warrant became exercisable for an aggregate of 14,884 shares of our common stock at an exercise price of $7.558 per share upon the completion of our IPO.

Future Capital Requirements

As of June 30, 2021, we had cash and cash equivalents in the amount of $304.4 million. Based upon our current operating plans, we believe that our existing cash and cash equivalents, will be sufficient to fund our operations for at least the next 24 months. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward looking statement that involves risks and uncertainties, and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect. Additionally, the process of conducting preclinical studies and testing product candidates in clinical trials is costly, and the timing of progress and expenses in these studies and trials is uncertain.

Our future capital requirements are difficult to forecast and will depend on many factors, including but not limited to:

 

the type, number, scope, progress, expansions, results, costs and timing of, discovery, preclinical studies and clinical trials of our product candidates which we are pursuing or may choose to pursue in the future;

 

the costs and timing of manufacturing for our product candidates and commercial manufacturing if any product candidate is approved;

 

the costs, timing and outcome of regulatory review of our product candidates;

 

the costs and timing of developing our companion diagnostics, and the outcome of regulatory review;

 

the success of our current and any future collaborations, including the timing and amount of the milestone or other payments made to us under the Takeda Agreement, the Falk Agreement or any future collaboration agreements;

 

the costs of obtaining, maintaining and enforcing our patents and other intellectual property rights;

 

the additional costs we may incur as a result of operating as a public company, including our efforts to enhance operational systems and hire additional personnel, including enhanced internal controls over financial reporting;

 

the timing and amount of payments that we must make to the licensors and other third parties from whom we have in-licensed intellectual property rights related to our Prometheus360 platform and product candidates;

 

the costs associated with hiring additional personnel and consultants as our preclinical and clinical activities increase;

 

the costs and timing of maintaining our sales and marketing capabilities and any expansion thereof, including if any product candidate is approved;

 

our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products and companion diagnostics;

 

the terms and timing of establishing and maintaining collaborations, licenses and other similar arrangements; and

 

costs associated with any products or technologies that we may in-license or acquire.

30


 

 

Other than our collaboration agreements, we have no other committed sources of capital. Until we can generate a sufficient amount of product revenue to finance our cash requirements, if ever, we expect to finance our future cash needs primarily through equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Any future debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through other collaborations or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or commercialization efforts or grant rights to develop and market product candidates to third parties that we would otherwise prefer to develop and market ourselves.

Cash Flows

The following table shows a summary of our cash flows for the periods presented (in thousands):

 

 

 

Six Months Ended

June 30,

 

 

 

2021

 

 

2020

 

Net cash provided by (used in)

 

 

 

 

 

 

 

 

Operating activities from continuing operations

 

$

(24,351

)

 

$

(15,577

)

Operating activities from discontinued operations

 

 

 

 

 

(2,584

)

Investing activities from continuing operations

 

 

(580

)

 

 

(186

)

Investing activities from discontinued operations

 

 

 

 

 

(942

)

Financing activities

 

 

275,119

 

 

 

35,386

 

Net increase in cash and cash equivalents

 

$

250,188

 

 

$

16,097

 

 

Operating Activities

Cash used by operating activities from continuing operations was $24.4 million during the six months ended June 30, 2021 as compared to cash used in operating activities of $15.6 million during the six months ended June 30, 2020. The increase of $8.8 million was primarily the result of the increase in net loss between the two periods of $18.8 million and increased payments in connection with an increase in research and development activities, our expansion of our executive team and us becoming a public company.

Investing Activities

Including the operations of PLI, net cash used by investing activities was $0.6 million during the six months ended June 30, 2021 as compared to net cash used in investing activities $1.1 million during the six months ended June 30, 2020, due to purchases of property and equipment.

Financing Activities

Net cash provided by financing activities was $275.1 million during the six months ended June 30, 2021 as compared to $35.4 million during the six months ended June 30, 2020. During the six months ended June 30, 2021, we received proceeds of $201.2 million from the sale of our common stock in our IPO, net of issuance costs paid during the period, and proceeds of $73.7 million from the sale of shares of our Series D-2 convertible preferred stock, net of issuance costs. During the six months ended June 30, 2020, we received $28.0 million from the issuance of our Series C convertible preferred stock, net of issuance costs, and $7.3 million from proceeds under the Loan Agreement with Oxford.

Critical Accounting Polices and Estimates

This management discussion and analysis of financial condition and results of operations is based on our financial statements, which have been prepared in accordance with GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities revenue and expenses.

31


 

On an ongoing basis, we evaluate these estimates and judgments. We base our estimates on historical experience and on various assumptions that we believe to be reasonable under the circumstances. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities and the recording of revenue and expenses that are not readily apparent from other sources. Actual results may differ materially from these estimates.

Our significant accounting policies are described in more detail in Note 2 to our consolidated financial statements included in the Prospectus dated March 11, 2021 filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, with the SEC on March 12, 2021 and in Note 2 to our condensed consolidated financial statements included elsewhere in this Quarterly Report.  We believe that the accounting policies related to revenue recognition, stock-based compensation and accrued research and development costs are the most critical to understanding and evaluating our historical and future performance.

Recent Accounting Pronouncements

See Note 2 to our condensed consolidated financial statements included elsewhere in this Quarterly Report for a description of recent accounting pronouncements.

Contractual Obligations and Commitments

During the six months ended June 30, 2021, other than the two items discussed below, there have been no material changes outside of the ordinary course of business in the composition of these contractual obligations or commitments as discussed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Contractual Obligations and Commitments” in the Prospectus.

 

In March 2021, the Company executed a non-cancellable lease agreement for office and laboratory space in San Diego, California. The lease has an initial term of ten years, following the commencement date with an option to extend the lease for an additional five-year term. The lease provides for initial monthly rental payments of approximately $0.2 million with rent escalation and the Company is also responsible for certain operating expenses and taxes throughout the lease term. The Company expects the lease to commence by the first quarter of 2022 (see Note 9 to our condensed consolidated financial statements included elsewhere in this Quarterly Report).  The table included in the Prospectus as of December 31, 2020 does not include amounts for the payment obligations entered into in connection with this lease agreement.

 

On July 8, 2021, the Company voluntarily prepaid the aggregate outstanding principal balance of $7.5 million plus an additional $0.5 million consisting of the prepayment penalty and accrued interest due under the terms of the Loan Agreement.

Off-Balance Sheet Arrangements

During the periods presented we did not have, nor do we currently have, any off-balance sheet arrangements as defined under the rules and regulations of the SEC.

JOBS Act

As an emerging growth company under the Jumpstart Our Business Startups Act of 2012 (JOBS Act), we can take advantage of an extended transition period for complying with new or revised accounting standards. This allows an emerging growth company to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves of this exemption from new or revised accounting standards and, therefore, will not be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies. We intend to rely on other exemptions provided by the JOBS Act, including without limitation, not being required to comply with the auditor attestation requirements of Section 404(b) of Sarbanes-Oxley. 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 will remain an emerging growth company until the earliest of (i) the last day of the fiscal year following the fifth anniversary of the consummation of our IPO, (ii) the last day of the fiscal year in which we have total annual gross revenue of at least $1.07 billion, (iii) the last day of the fiscal year in which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of our common stock held by non-affiliates exceeded $700.0 million as of the last business day of the second fiscal quarter of such year, or (iv) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period.

 

32


 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk  

Not required.

Item 4.

Controls and Procedures

Conclusion Regarding the Effectiveness of Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed by us in our reports that we file or submit pursuant to the Securities Exchange Act of 1934, as amended (the Exchange Act), is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow for timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Under the supervision and with participation of our management, including our Chief Executive Officer and our Chief Financial Officer, we carried out an evaluation of the effectiveness of our disclosure controls and procedures (as such term is defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered by this report. Based on this evaluation and the material weakness previously identified and further discussed below, our Company’s Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were not effective at the reasonable level of assurance.

 

Material Weakness in Internal Control over Financial Reporting

We identified deficiencies in our internal controls over financial reporting related to a lack of controls in the financial closing and reporting process, including a lack of segregation of duties and the documentation and design of formalized processes and procedures in the revenue cycle. In February 2021, we reported these deficiencies to the Audit Committee of our Board of Directors and a material weakness related to these deficiencies existed at December 31, 2020.

Remediation Efforts related to the Material Weakness During 2020 and 2021

The material weakness in our internal controls over financial reporting relates to a lack of controls in the financial closing and reporting process, including a lack of segregation of duties and the documentation and design of formalized processes and procedures in the revenue cycle that existed as a result of our limited number of accounting personnel.  This resulted in a reasonable possibility that a material misstatement of our annual or interim financial statements may not be prevented or detected on a timely basis. To remediate the deficiencies described above and prevent similar deficiencies in the future, we began to take steps to address the material weakness through our remediation plan, which included the hiring of additional personnel and the engagement of external advisors to provide financial accounting assistance in the short term. We have hired additional personnel to improve the segregation of duties in our financial closing and reporting process and engaged external advisors to evaluate and document the design and operating effectiveness of our internal controls and assist with the remediation and implementation of our internal controls as required.

Although we have begun the implementation of these remediation efforts, the deficiencies will not be considered fully remediated until the applicable remedial controls operate for a sufficient period of time and management has concluded, through testing, that these controls are operating effectively. Any actions we have taken or may take to remediate these deficiencies are subject to continued management review supported by testing, as well as oversight by the Audit Committee of our Board of Directors.

 

We cannot provide complete assurance that other material weaknesses or significant deficiencies will not occur in the future or that we will be able to remediate such weaknesses or deficiencies in a timely manner. The occurrence of such material weaknesses or our inability to remediate these deficiencies could impair our ability to accurately and timely report our financial position, results of operations or cash flows.

 

Changes in Internal Control over Financial Reporting

Other than in connection with implementing a plan to remediate the material weakness described above, there has been no change in our internal control over financial reporting identified in connection with the evaluation required by paragraph (d) of Rules 13a-15 or 15d-15 under the Exchange Act that occurred during the three months ended June 30, 2021, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

33


 

PART II. OTHER INFORMATION

Item 1.

We are not currently subject to any material legal proceedings. From time to time, we may be involved in legal proceedings or subject to claims incident to the ordinary course of business. Regardless of the outcome, such proceedings or claims can have an adverse impact on us because of defense and settlement costs, diversion of resources and other factors, and there can be no assurances that favorable outcomes will be obtained.

Item 1A.

Risk Factors

There have been no material changes to the risk factors disclosed in Part II, Item 1A, “Risk Factors” of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2021.

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

Unregistered Sales of Equity Securities

None.

Use of Proceeds

On March 11, 2021, our registration statement on Form S-1 (File No. 333-253323) was declared effective by the SEC for our IPO. At the closing of the offering on March 16, 2021, we sold 11,500,000 shares of common stock, which included the exercise in full by the underwriters of their option to purchase 1,500,000 additional shares, at an initial public offering price of $19.00 per share and received gross proceeds of $218.5 million, which resulted in net proceeds to us of approximately $199.8 million, after deducting underwriting discounts and commissions of approximately $15.3 million and offering-related transaction costs of approximately $3.4 million. None of the expenses associated with the initial public offering were paid to directors, officers, persons owning ten percent or more of any class of equity securities, or to their associates, or to our affiliates. SVB Leerink LLC and Credit Suisse Securities (USA) LLC acted as joint book-running managers for the offering.

As of June 30, 2021, we have not used any of the proceeds from our IPO.  There has been no material change in the planned use of proceeds from our initial public offering from that described in the Prospectus.

Issuer Repurchases of Equity Securities

None.

Item 3.

Defaults Upon Senior Securities

Not Applicable.

Item 4.

Mine Safety Disclosures

Not Applicable.

Item 5.

Other Information

None.

34


 

Item 6.

Exhibits

 

Exhibit

Number

 

Exhibit Description

 

Incorporated by Reference

 

Filed

Herewith

 

 

 

 

Form

 

Date

 

Number

 

 

3.1

 

Amended and Restated Certificate of Incorporation

 

8-K

 

3/17/2021

 

3.1

 

 

 

 

 

 

 

 

 

 

 

 

 

3.2

 

Amended and Restated Bylaws

 

8-K

 

3/17/2021

 

3.2

 

 

 

 

 

 

 

 

 

 

 

 

 

4.1

 

Specimen stock certificate evidencing the shares of common stock

 

S-1/A

 

3/8/21

 

4.1

 

 

 

 

 

 

 

 

 

 

 

 

 

4.2

 

Amended and Restated Investors’ Rights Agreement, dated October 30, 2020, by and among the Registrant and certain of its stockholders

 

S-1

 

2/19/21

 

4.2

 

 

 

 

 

 

 

 

 

 

 

 

 

4.3

 

Warrant issued to Oxford Finance LLC, dated January 24, 2020

 

S-1

 

2/19/21

 

4.3

 

 

 

 

 

 

 

 

 

 

 

 

 

10.1

 

Amended and Restated Exclusive License Agreement, dated August 6, 2021, by and between Cedars-Sinai Medical Center and the Registrant

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

31.1

  

Certification of Chief Executive Officer of Prometheus Biosciences, Inc., as required by Rule 13a-14(a) or Rule 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

31.2

  

Certification of Chief Financial Officer of Prometheus Biosciences, Inc., as required by Rule 13a-14(a) or Rule 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

 32.1*

  

Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

 32.2*

  

Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

  101.INS

 

Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document.

 

 

 

 

 

 

 

X

  101.SCH

 

Inline XBRL Taxonomy Extension Schema Document

 

 

 

 

 

 

 

X

  101.CAL

 

Inline XBRL Taxonomy Extension Calculation Linkbase Document

 

 

 

 

 

 

 

X

  101.DEF

 

Inline XBRL Taxonomy Extension Definition Linkbase Document

 

 

 

 

 

 

 

X

  101.LAB

 

Inline XBRL Taxonomy Extension Label Linkbase Document

 

 

 

 

 

 

 

X

  101.PRE

 

Inline XBRL Taxonomy Extension Presentation Linkbase Document

 

 

 

 

 

 

 

X

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

 

 

 

 

 

*

This certification is deemed not filed for purpose of section 18 of the Exchange Act or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.

35


 

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.

 

 

 

PROMETHEUS BIOSCIENCES, INC.

 

 

 

 

Date:

August 11, 2021

By:

/s/ Mark C. McKenna

 

 

 

Mark C. McKenna

 

 

 

President and Chief Executive Officer

 

 

 

(Principal Executive Officer)

 

 

 

 

Date:

August 11, 2021

By:

/s/ Keith W. Marshall, Ph.D.

 

 

 

Keith W. Marshall, Ph.D.

 

 

 

Chief Financial Officer

 

 

 

(Principal Financial and Accounting Officer)

 

36

Exhibit 10.1

 

[***] Certain information in this document has been excluded pursuant to Regulation S-K,

Item 601(b)(10). Such excluded information is not material and would likely cause

competitive harm to the registrant if publicly disclosed.

AMENDED AND RESTATED EXCLUSIVE LICENSE AGREEMENT

This Amended and Restated Exclusive License Agreement (“Agreement”) is entered into as of August 6, 2021 (“A&R Effective Date”) by and between Cedars-Sinai Medical Center, a California nonprofit public benefit corporation (“CSMC”), with offices at 8700 Beverly Boulevard, Los Angeles, California 90048-1865, and Prometheus Biosciences, Inc., a Delaware corporation (“Licensee”), with offices at 9410 Carroll Park Drive, California 92121.

R E C I T A L S

A.CSMC owns and/or is entitled to grant license rights with respect to certain Patent Rights (as defined below) and Technology (as defined below) invented, collected or otherwise developed in the conduct of inflammatory bowel disease research at CSMC, including through the operation of its Inflammatory Bowel Disease Drug Discovery and Development Unit.

B.CSMC desires to have the Patent Rights and the Technology developed, used and commercialized in the Field of Use (as defined below) by Licensee, and Licensee desires an exclusive, worldwide license to conduct research in the Field of Use, and to develop, manufacture, use and sell Products (as defined below) in the Field of Use, using the Patent Rights and Technology in accordance with the terms of this Agreement.  CSMC and Licensee entered into an Exclusive License Agreement, effective as of September 1, 2017 (the “Effective Date”), as amended by Amendment Number One to Exclusive License Agreement effective as of March 22, 2019, to effect the foregoing (such agreement, as amended, the “Original Agreement”).  

C.CSMC and Licensee desire to amend and restate the Original Agreement to reflect the agreements of the parties to be effective as of the Effective Date or, as otherwise expressly set forth in this Agreement, on the A&R Effective Date, all on the terms and conditions set forth below.

D.CSMC and Licensee intend that the execution, delivery and performance of this Agreement by each party, and the consummation of the transactions contemplated hereunder, shall not at any time threaten CSMC’s tax-exempt status under Section 501(c)(3) of the Internal Revenue Code and Section 23701d of the California Revenue and Taxation Code, or cause CSMC to be in default under any of CSMC’s issued and outstanding tax-exempt bonds.  Other than the rights expressly granted by CSMC hereunder within the Field of Use, Licensee acknowledges that CSMC shall retain all other rights with respect to the Patent Rights and the Technology.

Now, Therefore, in consideration of the mutual covenants and premises herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are

 


 

hereby acknowledged, the parties hereto hereby agree, effective as of the Effective Date or, as otherwise expressly set forth in this Agreement to be effective on the A&R Effective Date, as follows:

1.

Definitions

1.1“Affiliate” or “Affiliates” shall mean any corporation, person or entity which controls, is controlled by, or is under common control with, a party to this Agreement without regard to stock or other equity ownership.  For purposes hereof, the terms “control” and “controls” mean the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a corporation, person or entity, whether through the ownership of voting securities, by contract or otherwise.

1.2“Commercially Reasonable Efforts” shall mean, with respect to the performance of development or commercialization activities with respect to a Product by Licensee, the carrying out of such activities using efforts and resources comparable to the efforts and resources a similarly situated company in the research-based bio-pharmaceutical industry for compounds or products of similar commercial and scientific potential at a similar stage in development or product life, taking into account relevant factors, including without limitation the competitive landscape, the nature and extent of market exclusivity (including without limitation patent coverage and regulatory exclusivity), the likelihood, timing or existence of generic products, technical, legal, scientific, and medical factors, such Product’s safety and efficacy, its time and cost to develop, the likelihood of regulatory approval, its reasonably expected or actual labeling, its reasonably expected or actual profitability, the amounts of marketing and promotional expenditures with respect to the Product, its reasonably expected or actual pricing, reimbursement and formulary status, and the cost of any studies necessary or reasonably useful to obtain favorable pricing, reimbursement or formulary status for the Product.  “Commercially Reasonable Efforts” may be determined with reference to specific markets or group of markets.

1.3“Confidential Information” shall mean any confidential or proprietary information furnished by one party (the “Disclosing Party”) to the other party (the “Receiving Party”) in connection with this Agreement, including, without limitation, all specifications, know‑how, trade secrets, technical information, drawings, software, models, business information and patent applications pertaining to the Patent Rights and Technology, and as further provided in Section 10 hereof.

1.4“FDA” shall mean the United States Food and Drug Administration, or any successor agency thereof.

1.5“Field of Use” shall mean products and services for human use, including but not limited to the diagnosis, prognosis, prophylaxis and/or treatment of diseases and disorders in humans.  

1.6“Funding Agencies” shall mean any public or private granting agencies which have provided funding to CSMC or to any of the Inventors for the development of any of the Patent Rights or Technology prior to the Effective Date.  

 

2


 

1.7“Future Patent Rights” shall mean any patents and/or patent applications claiming Inventions invented after the Effective Date through any use of the Patent Rights and Technology licensed hereunder arising from work conducted or overseen by the Inventors in connection with their employment by CSMC, and any patents and/or patent applications (including provisional patent applications) in any other country corresponding to any of the foregoing, and all divisions, continuations, continuations-in-part, reissues, reexaminations, supplementary protection certificates and extensions thereof, whether domestic or foreign, and any patent that issues thereon; provided that only those patents and patent applications which are owned or controlled by CSMC shall be deemed to be “Future Patent Rights”. Notwithstanding anything to the contrary in the foregoing, “Future Patent Rights” shall not include any patent right included in the Patent Rights, including any patents and/or patent applications which claim or cover any Related Invention(s).

1.8“Invention” shall mean all unpatented, patentable and patented inventions, discoveries, designs, apparatuses, systems, machines, methods, processes, uses, devices, models, composition of matter, technical information, trade secrets, know-how, codes, programs or configurations of any kind which are in or can otherwise be applied to the Field of Use.

1.9“Inventors” shall mean [***].

1.10“Licensee Compound” shall mean a proprietary compound which is owned by Licensee or a third party and which was not developed through any use of CSMC’s Technology or Patent Rights.

1.11“Milestones” shall mean any and all milestones set forth in Schedule B of this Agreement.  

1.12“MIRIAD Biobank” shall mean CSMC’s Mucosal Immunology Repository for Inflammatory and Digestive Diseases, a specialized biobank for advancing research in inflammatory diseases, which includes a biorepository collection of samples obtained from research subjects, which samples it uses, among other things, in the research and development of diagnostic and therapeutic products for the treatment of inflammatory diseases, and in the development of a database of information, including without limitation information relating to target identification and validation, patient stratification, and prediction of clinical efficacy.

1.13“Net Sales” shall mean the gross amount actually received or invoiced (in accordance with Section 4.2(f)(i)) for all sales of Products to third parties (other than Sublicensees) by Licensee, its Affiliates, Sublicensees, and affiliates of Sublicensees less [***].  If a Product is sold or provided as part of a system, package, or combination product or service that involve one or more products or services not covered by the Patent Rights (each, a “Combination Product”), Net Sales shall be calculated by [***].  In the event that no market price is available for the Product included in such Combination Product when supplied or priced separately, [***].  

1.14“Patent Rights” shall mean (a) the patents and/or patent applications which are described on Schedule A of this Agreement, (b) any patents and/or patent applications which claim or cover any Related Invention(s), and (c) all patents and/or patent applications (including provisional patent applications) in any other country corresponding to any of the foregoing, and all divisions, continuations, continuations-in-part, reissues, reexaminations, supplementary

 

3


 

protection certificates and extensions thereof, whether domestic or foreign, all claims of continuations-in-part that are entitled to the benefit of the priority date of any of the foregoing, and any patent that issues thereon.  

1.15“Product” or “Products” shall mean any Diagnostic Product or Therapeutic Product.  

“Diagnostic Product” shall mean any product and/or service in the Field of Use that: (a) (i) except for the license granted hereunder, would infringe a Valid Claim, or (ii) is wholly or partially developed through any use of the Technology, including targets selected using the Technology, and (b) that is marketed, indicated, approved and/or used for diagnostic or prognostic purposes, including without limitation the screening of patients for potential responsiveness to a particular therapeutic, prophylactic or other clinical intervention.

“Therapeutic Product” shall mean any product and/or service in the Field of Use that: (a) (i) except for the license granted hereunder, would infringe a Valid Claim, or (ii) is wholly or partially developed through any use of the Technology and (b) that is marketed, indicated, approved and/or used for therapeutic, prophylactic or preventative purposes.

For the sake of clarity, in the event that Licensee develops a therapeutic product and related diagnostic product that is wholly or partially developed through any use of the Technology, such therapeutic product of Licensee shall be deemed a Therapeutic Product and such related diagnostic product of Licensee shall be deemed a separate and distinct Diagnostic Product; provided that “Therapeutic Product” shall not include (a) any product or service for which the sole contribution of a Product to its development is use of a Diagnostic Product to select patients for research, development, clinical trials, and/or commercialization of a product, (b) any product that is developed solely through the use of targets selected using the Technology; provided, that any such product may be considered a “Diagnostic Product” hereunder, (c) any Licensee Compounds that are used in accordance with Section 2.8, and/or (d) any Licensee Compounds that are used by Licensee (acting on its own or through consultants and without any involvement of CSMC, whether through the MRSA, the MRCA, Consulting Agreements, or otherwise) along with the Technology licensed under this Agreement solely to potentially assist in the development of Diagnostic Products to select patients for research, development, clinical trials and/or commercialization of such Licensee Compounds; provided further that to the extent that Licensee develops any Diagnostic Products through its use of the Technology and such Licensee Compounds, Licensee shall be obligated to pay CSMC the Diagnostic Product Royalty Rate with respect to such Diagnostic Products.  

If a Product meets the definition of both a Diagnostic Product and a Therapeutic Product under this Section 1.15, then the Product shall be deemed a Therapeutic Product.

1.16“Related Inventions” shall mean any and all Inventions which (i) result from the services performed under the following agreements:  (a) any consulting agreement between Licensee and any employee of CSMC, including without limitation any Inventor, (such consulting agreements collectively, the “Consulting Agreements”), (b) the Master Collaborative Research Agreement between CSMC and Licensee, effective as of the Effective Date (“Master Collaborative Research Agreement”), and/or (c) the Master Research Services Agreement between CSMC and Licensee, effective as of the Effective Date (“Master Research Services

 

4


 

Agreement”), as each may be amended; (ii) would have been reasonably anticipated at the outset of such services, as applicable, to be developed; (iii) are related to the Technology and/or patents and/or patent applications described on Schedule A of this Agreement; and (iv) with respect to which CSMC owns or otherwise controls intellectual property rights.    

1.17“Technology” shall mean information and materials in the Field of Use that (a) are included in and relate to the MIRIAD Biobank, (b) result from CSMC’s analysis of the MIRIAD Biobank, including any associated proprietary algorithms, or (c) identify single nucleotide polymorphisms, serological markers or any combination thereof and/or targets obtained through such analysis, which information and materials are provided by or otherwise made available by CSMC to Licensee under this Agreement. “Technology” shall further include any additional information and materials developed by any of the Inventors in the conduct of their research in connection with CSMC’s Inflammatory Bowel Disease Drug Discovery and Development Unit or that is incorporated in any Related Invention, including, but not limited to, know-how, trade secrets, unpublished patent applications, clinical or research data, software, bioinformatics, unpatented technology, technical information, statistical information and analyses, biological materials, chemical reagents, preclinical and clinical information, which information and materials are provided by CSMC to Licensee under this Agreement or any of the Agreements described in Section 1.17(i)(b) or (c).  With the exception of the information and materials that are included in and relate to the MIRIAD Biobank, for purposes of the definition of “Product,” “Technology” shall not include any information or materials developed after the Effective Date that, at the time of disclosure to Licensee, has already been first disclosed or made available to a third party, including, for example, any commercially available assays.  As between the parties, the Technology is all owned by CSMC, except as otherwise set forth in Section 2.8.  

1.18“Territory” shall mean the entire world.

1.19“Valid Claim” shall mean a claim of an issued patent included within the Patent Rights, which claim has not (a) lapsed, been canceled or become abandoned, (b) been declared invalid or unenforceable by a non-appealable decision or judgment of a court or other appropriate body or authority of competent jurisdiction, or (c) been admitted to be invalid or unenforceable through reissue, disclaimer or otherwise.  The term Valid Claim shall also include the claims of a pending patent application within the Patent Rights for a period of [***] years from the actual filing date of that patent application.

1.20“Work Order” shall mean any Work Order under the Master Collaborative Research Agreement or the Master Research Services Agreement (each as defined in Section 1.16 hereof), as may be amended.

2.License

2.1Grant of Exclusive Rights.  Subject to the terms of this Agreement, CSMC hereby grants to Licensee, and Licensee hereby accepts from CSMC, the exclusive license, with the right to grant sublicenses (subject to the terms of Section 2.2 hereof), under CSMC’s right, title and interest in and to the Patent Rights and to the Technology, during the Agreement Term (as provided in Section 6 hereof) to conduct research and development in the Field of Use and/or to make, have made, use, import, offer for sale, have offered for sale, sell and/or have sold Products in the Field

 

5


 

of Use in the Territory.  The foregoing grant of exclusivity is made expressly subject to the following:

(a)All applicable laws and regulations, including, without limitation, the requirements of federal law as pertains to the manufacture of products within the United States;

(b)All applicable rules of the Funding Agencies;

(c)The rights of any co-owners of any Patent Rights and/or Technology, if any, which rights are set forth on Schedule A of this Agreement, as applicable;  

(d)The following non-exclusive rights to the Patent Rights and Technology, which are retained by CSMC within the Field of Use:

(i)subject to Licensee’s right to prior review as set forth herein, the right to submit for publication the scientific findings from research conducted by or through CSMC or its investigators (including the Inventors) related to the Patent Rights and Technology; provided, that no such publications shall include any Confidential Information of Licensee.  Licensee shall have the right to review any proposed publication of (A) the scientific findings from research conducted by CSMC related to the Patent Rights on which an Inventor is named as a lead author; and/or (B) jointly-owned Study Data (as such term is defined in the Master Collaborative Research Agreement and the Master Research Services Agreement) (“Covered Publication”).  CSMC shall deliver to Licensee a copy of the Covered Publication at least [***] days prior to submission for publication.  Licensee may then, within [***] days of the delivery of such Covered Publication to Licensee:  (a) require the deletion of any Confidential Information of Licensee which is included in the Covered Publication; or (b) request in writing from CSMC an reasonable extension of Licensee’s review period for a mutually agreed upon additional time period (of no more than [***] days from the date of such request unless otherwise agreed to by CSMC), provided that such delay is requested by Licensee to protect patentable subject matter; and

(ii)the right (A) to exploit the Patent Rights, the Technology and any tangible or intangible information contained therein for CSMC’s research, internal teaching and other educationally-related, clinical and non-commercial clinical study purposes, where clinical use does not involve a third party funding grant to commercialize such information, and (B) to obtain research funding for further study and development thereof from governmental and other nonprofit organizations (including grant applications).

(e)Notwithstanding any other provision hereof to the contrary, all rights to the Patent Rights and Technology outside of the Field of Use are retained by CSMC.

2.2Sublicensing.

(a)Permitted Sublicensing.  Licensee shall have the right to grant sublicenses under any or all of the rights granted hereunder to its Affiliates and to (i) public companies listed on the NYSE or NASDAQ stock exchanges or any foreign equivalent thereof; (ii) private companies having at least $[***] in annual sales or cash on its balance sheet at the time the sublicense is entered into; (iii) Prometheus Laboratories Inc. or (iv) entities which have been approved in writing by CSMC (such consent not to be unreasonably withheld, delayed, or

 

6


 

conditioned); provided that, in the event that CSMC has not responded to any request for approval from Licensee within [***] days of receiving such request, such request shall be deemed approved (each, a “Sublicensee”).  Without limiting the generality of the foregoing, it shall be unreasonable for CSMC to withhold approval of a potential sublicensee if such potential sublicensee has a level of science, management and investors commensurate with or greater than Licensee or which is otherwise of a reasonably sufficient level to carry out the rights and obligations being sublicensed to it. In any business transaction that results, in whole or in part, with a third party selling any Product for which Licensee would owe CSMC Royalties pursuant to this Agreement if Licensee sold such Product, then Licensee shall grant a sublicense to such third party memorializing such grant of rights, any such third party shall be deemed to be a “Sublicensee” hereunder, and Royalties shall be due and payable by Licensee with respect to any and all sales of Products by such Sublicensee.  

(b)Sublicensing Generally.  Any Sublicensee shall be subject in all respects to the provisions contained in this Agreement and Licensee will remain primarily liable to CSMC for, and shall be responsible for monitoring and enforcing, performance of all of Licensee’s obligations hereunder by any such Sublicensee.  Without limiting the generality of the foregoing, as an express condition of any such sublicense, any such Sublicensee shall be required to agree in writing to be bound by commercially reasonable reporting and record keeping, indemnification and inspection provisions, and the applicable provisions of this Agreement, including, without limitation, those pertaining to the payment of Royalties, use of CSMC’s name and marks, indemnification of CSMC and the use of CSMC’s Confidential Information.  Sublicensees may further sublicense the rights granted hereunder to (a) public companies listed on the NYSE or NASDAQ stock exchanges or any foreign equivalent thereof; (b) private companies having at least $[***] in annual sales or cash on its balance sheet at the time the sublicense is entered into; and (c) entities which have been approved in writing by CSMC (such consent not to be unreasonably withheld, delayed, or conditioned); provided that, in the event that CSMC has not responded to any request for approval from such Sublicensee within [***] days of receiving such request, such request shall be deemed approved.  Without limiting the generality of the foregoing, it shall be unreasonable for CSMC to withhold approval of a potential subsublicensee if such potential subsublicensee has a level of science, management and investors commensurate with or greater than Licensee or which is otherwise of a reasonably sufficient level to carry out the rights and obligations being sublicensed to it.  Licensee shall promptly forward to CSMC a copy of any and all fully executed sublicense agreements and subsublicense agreements, any subsequent amendments, and all copies of Sublicensees’ profit sharing or royalty reports, in no event more than [***] days following execution or receipt thereof, as applicable.  Licensee shall also keep CSMC reasonably informed with respect to the progress of any relations entered into with any Sublicensees.  If Licensee shall conduct one or more audits of its Sublicensees hereunder during the term hereof, Licensee shall provide copies of any audit report indicating an underpayment or overpayment to CSMC on a timely basis.  The covenants pertaining to the payment of Royalties, the use of CSMC’s name and marks, the indemnification of CSMC and the use of CSMC’s Confidential Information in any sublicense or assignment shall run for the benefit of CSMC, who shall be expressly stated as being a third-party beneficiary thereof with respect to the covenants set forth in this Agreement.  Licensee understands and agrees that none of its permitted sublicenses hereunder shall reduce in any manner any of its obligations set forth in this Agreement.

 

7


 

2.3 Subject (a) to the applicable rules of the Funding Agencies and (b) to the extent it would not impair or jeopardize any efforts of CSMC to obtain domestic or foreign rights thereto, CSMC shall promptly (but no later than [***] days after CSMC’s Technology Transfer Office receives an invention disclosure form with respect thereto) notify Licensee in writing and in adequate detail of any Inventions which constitute Future Patent Rights and associated Technology (the “Future Patent Right Notification”); provided that CSMC’s obligations with respect to Future Patent Rights set forth in this Section 2.3 shall be subject to any and all legal obligations of CSMC that exist as of the Effective Date.  Such disclosures shall be deemed the Confidential Information of CSMC. Subject to the Funding Agency Rules, Licensee shall have, for a period of [***] days (the “Negotiation Period”) after receipt of the future Patent Right Notification, the exclusive first right to negotiate with CSMC to obtain one or more exclusive licenses in the Field of Use and the Territory to the Future Patent Rights and Technology set forth in such Future Patent Right Notification upon such terms and conditions as shall be agreed by the parties hereto, which terms and conditions shall include provisions for fair market value consideration for the grant of any such licenses.  If Licensee declines or fails to pursue, or if the parties fail to execute an amendment to this Agreement to include such Future Patent Rights in the Field of Use during the [***] day period specified above, then CSMC shall have the right to commence discussions with any other party (the “Proposed Transaction”) concerning such Future Patent Rights and Technology, provided that such transaction shall (i) not conflict with any of Licensee’s rights and/or CSMC’s obligations under this Agreement and (ii) be on terms and conditions no more favorable to such third party than those last offered by CSMC to Licensee during the Negotiation Period.  Subject to the provisions of this Section 2.3, Licensee acknowledges and agrees that CSMC expressly retains and reserves any and all right, title and interest in and to the Future Patent Rights, whether or not in the Field of Use and, accordingly, no license to any Future Patent Rights is granted to Licensee under this Agreement unless and until an amendment to this Agreement is executed with respect thereto by the parties, and upon such execution such Future Patent Rights shall be deemed Patent Rights.  

2.4Diligent Commercialization. Licensee acknowledges that it is important to CSMC, and a requirement of the United States Government under Title 35, Section 203 of the United States Code, that Licensee pursue the development, commercialization and marketing of Products.  Without limiting the foregoing, Licensee shall use Commercially Reasonable Efforts to develop and make Products commercially available to the public as soon as commercially practicable within the Territory.  As part of Licensee’s obligation to use such Commercially Reasonable Efforts, CSMC and Licensee shall agree on the Milestones set forth in Schedule B of this Agreement, and Licensee shall use Commercially Reasonable Efforts to achieve such Milestones.  Licensee’s failure to achieve any particular Milestone shall not, in and of itself, signify that Licensee failed to exercise Commercially Reasonable Efforts.  Within [***] days after each anniversary of the Effective Date, Licensee shall prepare and deliver to CSMC an annual written report describing the development and commercialization activities it has performed, or caused to be performed, since the preceding report.  Each such report shall contain information reasonably required by CSMC to evaluate Licensee’s performance under this Agreement, including Licensee’s progress toward achievement of the Milestones.  

2.5Preference for United States Industry.  To the extent that any of the Patent Rights have been developed using funding from the United States Government, Licensee agrees that any

 

8


 

Products claimed by such Patent Rights that are made, used or sold in the United States shall be manufactured substantially in the United States, to the extent required under applicable law.

2.6 Access to Biobank and Biological Materials.  CSMC maintains as of the Effective Date, and will continue to develop during the Agreement Term, the MIRIAD Biobank. Subject to availability and CSMC’s institutional policies and procedures for the transfer of biological materials, including the terms and conditions of the Material Transfer Terms (attached as Schedule C of this Agreement), CSMC shall make available to Licensee during the Agreement Term the MIRIAD Biobank.

2.7Collaboration.

(a)Governance.  The parties agree that this Agreement forms part of a collaborative effort between the parties to develop technologies and products pursuant to the rights licensed under this Agreement, including activities that may be performed under the Master Collaborative Research Agreement, the Master Research Services Agreement or any of the Consulting Agreements (the “Collaboration”).  Accordingly, as of the A&R Effective Date, the parties desire to establish a joint steering committee (the “JSC”) to oversee the interactions between the parties with respect to such efforts and shall do so within [***] days after the A&R Effective Date.  The JSC will have the following roles:

(i)discuss overall strategy for the research and development of Products;

(ii)facilitate communications, discussion, and the exchange of information between the parties, with respect to potential projects under consideration by Licensee;

(iii)discuss any proposed collaborative research and development studies to be conducted by CSMC and Licensee under the Master Collaborative Research Agreement or any proposed research services to be performed by CSMC under the Master Research Services Agreement, including without limitation [***];

(iv)oversee, coordinate, and monitor the progress of the work to be done by each of the Parties under Work Orders, including without limitation receiving regular reports from each of the parties detailing its respective activities and discuss the results of such activities, and any proposed amendments or revisions to Work Orders;

(v)coordinate the transfer of and/or access to Technology and Study Data between the parties, including data and/or samples from the MIRIAD Biobank, in accordance with Sections 2.1, 2.2, 2.6 and 2.8;

(vi)receive updates regarding Licensor’s efforts to maintain and update the MIRIAD Biobank pursuant to Section 2.6 and Licensee’s efforts to develop and enhance its access to samples obtained and data generated independently of CSMC;

(vii)discuss potential publications of Study Data, the timing thereof and intellectual property topics relating thereto, including proposed publications submitted to Licensee pursuant to Section 2.1(a)(i);

 

9


 

(viii)discuss intellectual property strategy and oversee intellectual property protection with respect to Related Inventions;

(ix)seek to resolve technical issues and disputes; and

(x)such other functions as may be assigned to it by the parties from time to time.

(b)Delegation; Authority; JSC Cessation.    The JSC may establish project teams comprised of representatives of the parties to take on projects and other tasks related to the Collaboration. The JSC and any such project team shall have only the powers assigned expressly to it in this Section 2.7 and elsewhere in this Agreement, and shall not have any power to amend, modify or waive compliance with this Agreement or any other agreement between the parties.  In furtherance thereof, each party shall retain the rights, powers and discretion granted to it under this Agreement and no such rights, powers or discretion shall be delegated or vested in the JSC or project team unless such delegation or vesting of rights is expressly provided for in this Agreement or the parties expressly so agree in writing.  For the avoidance of doubt, the rights of the JSC and any project team to discuss, comment, review or monitor (and other similar activities) shall not require any party or designee thereof to act or be bound in any respect by such discussion, comment, review, or monitoring.  Notwithstanding anything to the contrary in this Agreement, in no event will any action of the JSC or either party’s actions through the JSC constitute a breach or default of this Agreement that would result in a termination right pursuant to Section 6.2(b), (c), or (d).  The JSC shall remain in existence unless terminated by mutual written agreement of the parties or upon written notice from Licensee upon the cessation of activities performed by the parties under Collaboration; and, for clarity, no termination of the JSC shall result in termination or expiration of this Agreement.  

(c)Members of the JSC.  Each of Licensee and CSMC shall initially appoint three (3) representatives to the JSC, each of whom will be an officer or employee of the applicable party having sufficient seniority within such party to make decisions arising within the scope of the JSC’s responsibilities. The JSC may change its size from time to time by mutual consent of its members, and each party may replace its representatives at any time upon written notice to the other party; provided, that each party shall ensure that at all time during the existence of the JSC, its representatives on the JSC are appropriate in terms of expertise and seniority. The JSC shall have a chairperson, who shall be selected by Licensee. The role of the chairperson shall be to convene and preside at the meeting of the JSC and to ensure the preparation of meeting minutes, but the chairperson shall have no additional powers or rights beyond those held by other JSC representatives. For clarity, each party’s representatives shall comply with the obligations of confidentiality set forth in Section 10 of this Agreement.

(d)JSC Meetings.  The JSC shall meet at least [***] during the Agreement Term unless the parties mutually agree in writing to a different frequency for such meetings. Prior to any meeting of the JSC, the chairperson of the JSC shall prepare and circulate an agenda for such meeting; provided, however, that either party may propose additional topics to be included on such agenda, either prior to or in the course of such meeting. The JSC may meet in person or by teleconference, provided however, at least [***] meetings per Calendar Year shall be in person. In-person JSC meetings shall be held at locations alternately selected by CSMC and by Licensee. Each party shall bear the expense of its respective JSC members’ participation in JSC meetings.

 

10


 

Meetings of the JSC shall be effective only if at least one (1) representative of each party is present or participating in such meeting.  The JSC chairperson shall prepare and circulate for review and approval of the JSC minutes of each meeting.  The JSC shall agree on the minutes of each meeting as promptly as practicable following such meeting; provided that if no comments are received on such minutes within [***] days after a Party’s receipt of such minutes, such minutes will be deemed to be approved by such Party.

(e)JSC Decision-Making.  The JSC shall act by consensus. The representatives from each party will have, collectively, one (1) vote on behalf of that party. The JSC shall strive to seek consensus in its actions and decision making process. If after reasonable discussion and good faith consideration of each party’s view on a particular matter before the JSC, the JSC is still unable after a period of [***] days to reach a unanimous decision on such matter, then either party may refer such matter to the parties’ designative representatives who shall be the Chief Executive Officer of Licensee or his/her designee and the [***] of CSMC or his/her designee (the “Executive Officers”) for attempted resolution by good faith negotiation within [***] days after such matter has been referred to the Executive Officers. If the Executive Officers are not able to resolve such matter within such [***] day period, then Licensee’s Executive Officer shall have the right to decide such matter consistent with the terms of this Agreement and in good faith, provided that Licensee’s Executive Officer shall not have the power to [***].  For clarity, any controversy, claim, or dispute arising between the parties with respect to the enforcement or interpretation of this Agreement or any specific terms and provisions set forth in this Agreement outside of the scope of the JSC’s authority shall be handled in accordance with the procedures set forth in Section 13.3 and not by the JSC.

2.8Technology Developed Under MCRA and MRSA.  The parties acknowledge and agree that in accordance with the Master Collaborative Research Agreement and the Master Research Services Agreement, any and all Study Data (as defined therein) shall be jointly owned by CSMC and Licensee or solely owned by Licensee to the extent expressly set forth in the applicable Work Order.  The parties agree that all references to the License Agreement in the Master Collaborative Research Agreement, the Master Research Services Agreement, and any Consulting Agreement shall refer to this Agreement.  For purposes of Sections 2.1, 2.2 and 4.2, such jointly owned Study Data shall be deemed to be “Technology” as defined in Section 1.17 hereof. Furthermore, to the extent expressly set forth in the applicable Work Order, certain Inventions that necessarily use or necessarily incorporate any Licensee Compound provided by Licensee under the Work Order shall be owned, as between the parties, solely by Licensee, and CSMC hereby assigns to Licensee all right, title, and interest in and to any such inventions and all intellectual property rights therein.  The parties acknowledge and agree that (i) if, under any Work Order, any Licensee Compound is used in connection with the Technology solely to potentially assist in the development of Diagnostic Product(s) to select patients for research, development, clinical trials, and/or commercialization of such Licensee Compound(s), then in accordance with Section 1.15 of this Agreement, such Licensee Compound shall not be deemed to be a “Therapeutic Product” for purposes of this Agreement; (ii) regardless of the fact that certain Study Data is co-owned by Licensee and CSMC, to the extent that Licensee develops any Products through the use of such jointly-owned Study Data, Licensee shall be obligated to pay CSMC the applicable Royalty set forth in Section 4.2 of this Agreement with respect to such Products; and (iii) regardless of the fact that certain Study Data and/or Inventions are solely owned by Licensee as described in the applicable Work Order, to the extent that Licensee develops any Diagnostic Products through the

 

11


 

use of such Licensee-owned Study Data and/or Inventions, Licensee shall be obligated to pay CSMC the Diagnostic Product Royalty Rate with respect to such Diagnostic Products.

2.9Key Persons.  The following individuals are designated as “Key Persons” with respect to this Agreement: [***].  In the event that the services of any Key Person are lost to the projects covered by this Agreement (including, without limitation, the research conducted under any Work Order) for any reason, the applicable party hereto shall notify the other party in writing, and may propose substitute personnel to such other party.  The other party’s approval of such proposed substitute personnel shall not be withheld, conditioned or delayed unreasonably.  In the event that the parties are unable to identify mutually acceptable substitute personnel within [***] days of the provision of such written notice, then the parties may terminate this Agreement in accordance with Section 6.2(f) hereof.  

3.

Representations And Warranties

3.1Rights to Technology.  Except for the rights, if any, of the Funding Agencies or the United States Government, CSMC represents and warrants to Licensee that, to the best of its actual knowledge (without investigation outside of CSMC as to such representations and warranties) as of the Effective Date and the A&R Effective Date: (a) other than those Patent Rights that CSMC has designated in Schedule A as being co-owned by CSMC and Licensee or CSMC and a third party, CSMC exclusively owns all right, title and interest in and to and is the rightful assignee of the Patent Rights and/or Technology, (b) CSMC has the power and authority to enter into this Agreement and has the right to grant the licenses set forth in this Agreement, (c) CSMC has not granted licenses to the Patent Rights and/or Technology to any other party that would restrict or otherwise conflict with the rights granted hereunder except as stated herein, (d) no holding, decision, or judgment has been rendered in any action or proceeding before any court or administrative authority denying the validity of CSMC’s right to register, or CSMC’s rights to own, use or license, any Patent Rights and/or Technology, (e) there are no claims, judgments or settlements to be paid by CSMC with respect the Patent Rights and/or Technology or pending claims or litigation relating to the Patent Rights and/or Technology.  Except for the rights, if any, of the Funding Agencies or the United States Government, CSMC represents and warrants to Licensee that, to the best of the current, actual knowledge of the Inventors (without investigation outside of CSMC as to such representations and warranties), as of the Effective Date and the A&R Effective Date: (i) the Patent Rights are valid and enforceable, and (ii) no third party is infringing upon or otherwise misappropriating any Patent Rights and/or Technology.  Except for any potential or actual rights of Funding Agencies, CSMC is not aware that any additional rights or licenses are necessary for Licensee to exercise its licensed rights granted by CSMC under this Agreement.  CSMC covenants and agrees that if at any time during the Agreement Term it becomes aware that any of the representations and/or warranties set forth in this Section 3.1 are no longer true or correct had they been given after the Effective Date, it shall notify Licensee in writing of the facts or circumstances thereof within [***] days of discovery.

3.2Limited Warranty; LIMITATION OF LIABILITY.  

(a)Limited Warranty.  CSMC makes no representation or warranty other than those expressly specified in this Agreement.  Except as otherwise expressly set forth in this Agreement, Licensee accepts the Patent Rights and the Technology on an “AS-IS” basis.  Except as OTHERWISE EXPRESSLY SET FORTH in this Agreement, CSMC MAKES NO WARRANTIES CONCERNING PATENT RIGHTS OR TECHNOLOGY COVERED BY THIS AGREEMENT, INCLUDING WITHOUT LIMITATION, ANY EXPRESS OR IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AS TO PATENT RIGHTS, TECHNOLOGY OR ANY PRODUCT.  Except as OTHERWISE EXPRESSLY SET FORTH in this Agreement, CSMC MAKES NO WARRANTY OR REPRESENTATION AS TO THE VALIDITY OR SCOPE OF PATENT RIGHTS, OR THAT ANY PRODUCT WILL BE FREE FROM AN INFRINGEMENT ON PATENTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES, OR THAT NO THIRD PARTIES ARE IN ANY WAY INFRINGING PATENT RIGHTS COVERED BY THIS AGREEMENT.

 

12


 

(b)LIMITATION OF LIABILITY.  EXCEPT FOR THE BREACH OF THE CONFIDENTIALITY PROVISIONS IN SECTION 10 OR IN ACCORDANCE WITH THE OBLIGATION TO INDEMNIFY SET FORTH IN SECTION 8, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF PROFITS OR EXPECTED SAVINGS OR OTHER ECONOMIC LOSSES, OR FOR INJURY TO PERSONS OR PROPERTY) ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT OR ITS SUBJECT MATTER, REGARDLESS OF WHETHER SUCH PARTY KNOWS OR SHOULD KNOW OF THE POSSIBILITY OF SUCH DAMAGES.  EXCEPT FOR THE BREACH OF THE CONFIDENTIALITY PROVISIONS IN SECTION 10 OR IN ACCORDANCE WITH THE OBLIGATION TO INDEMNIFY SET FORTH IN SECTION 8, CSMC’S AGGREGATE LIABILITY FOR ALL DAMAGES OF ANY KIND RELATING TO THIS AGREEMENT OR ITS SUBJECT MATTER SHALL NOT EXCEED THE GREATER OF (1) [***] ($[***]) OR (2) [***].  THE FOREGOING EXCLUSIONS AND LIMITATIONS SHALL APPLY TO ALL CLAIMS AND ACTIONS OF ANY KIND, WHETHER BASED ON CONTRACT, TORT (INCLUDING, BUT NOT LIMITED TO NEGLIGENCE), OR ANY OTHER GROUNDS.

3.3Rights Retained by Funding Agencies.  Licensee acknowledges that to the extent that the Patent Rights and Technology have been developed in part under one or more funding agreements (“Funding Agreements”) with one or more Funding Agencies, such Funding Agencies have certain statutory, non-exclusive rights relative thereto for use for government purposes as well as regulatory or statutory “march-in rights” (collectively, “Statutory Rights”).  This Agreement is explicitly made subject to such Statutory Rights and, to the extent of any conflict between any such Statutory Rights and this Agreement, such Statutory Rights shall prevail.  CSMC has included in Schedule A of this Agreement information regarding any and all such Funding Agreements that exist as of the Effective Date.

4.

Consideration

In consideration of the execution and delivery by CSMC of this Agreement, Licensee agrees as follows:  

4.1Equity Grants.  

(a)As an upfront, nonrefundable payment, after the Effective Date, Licensee issued to CSMC two million five hundred seventy-five thousand (2,575,000) shares of Licensee’s

 

13


 

common stock, which was equal, in the aggregate, to [***] percent ([***]%) of the then outstanding shares of the capital stock of Licensee on a Fully Diluted Basis (as defined hereafter) (and, together with the shares issued to CSMC pursuant to Section 4.1(b) below, was equal to [***] percent ([***]%) of the outstanding shares of the capital stock of Licensee on a Fully Diluted Basis), as of the Effective Date.  For the purposes of this Agreement, “Fully Diluted Basis” shall include all of the issued and outstanding shares of common stock, preferred stock and other capital stock of the Licensee (calculated on an as-converted to common stock basis) (including the shares to be issued to CSMC pursuant to this Section 4.1 and Section 4.1(b) below) plus any then issued and outstanding options and warrants to purchase common stock (calculated on an as-exercised, as converted to common stock basis).  As of the Effective Date, there were no unissued but reserved shares of common stock of Licensee for future issuance as options or stock grants under a stock incentive plan of Licensee.

(b)As additional consideration for CSMC’s obligations under this Agreement, Licensee issued to CSMC three million three hundred fifty thousand (3,350,000) shares of Licensee’s common stock, as of the Effective Date.    

4.2Royalties.  

(a)Running Royalties for Products.  Licensee agrees to pay and shall pay to CSMC the following non-refundable running royalties (each, a “Royalty”) in the amounts set forth below:

(i)a running royalty of [***] on Net Sales of Diagnostic Products made, used or sold by Licensee, its Affiliates or any Sublicensee hereunder (“Diagnostic Product Royalty Rate”); and

(ii)a running royalty of [***] on Net Sales of Therapeutic Products made, used or sold by Licensee, its Affiliates or any Sublicensee hereunder (“Therapeutic Product Royalty Rate”).

(b)Permitted Deductions.  

(i)For any portion of the Royalty Term for a Diagnostic Product in a country during which there is no Valid Claim that covers such Diagnostic Product in such country, the Diagnostic Product Royalty Rate applicable to such Diagnostic Product in such country shall be reduced by [***].

(ii)For any portion of the Royalty Term for a Therapeutic Product in a country during which there is no Valid Claim that covers the composition of matter of such Therapeutic Product in such country, the Therapeutic Product Royalty Rate applicable to such Therapeutic Product in such country shall be reduced by [***].

(iii)If Licensee is required to make any payment to a third party to obtain a license for the manufacture, use, sale or import of a Product or otherwise exploit the Patent Rights, Licensee shall be entitled to deduct up to [***] of such third party payments made in a particular calendar quarter against Royalties payable to CSMC for that quarter; provided, however, that in no event shall the Royalties payable to CSMC hereunder for any calendar quarter be reduced by

 

14


 

operation of this Section 4.2(b)(iii) by more than [***]; provided, further, that any unused deduction earned in any calendar quarter may be carried forward from such calendar quarter to the subsequent calendar quarters and may be used in such subsequent calendar quarters, subject to the [***] limitation set forth in the immediately preceding proviso.

(c)Challenge of Patent Rights.  Should Licensee, its Affiliate or any Sublicensee bring, directly or through a third party indirectly, an action challenging the validity, scope or enforceability of any Patent Rights, Licensee, the Affiliate or the Sublicensee will first provide CSMC with at least [***] days’ prior written notice that it intends so to do before filing such a challenge.  Following the giving of such notice, Licensee, the Affiliate or the Sublicensee will continue to pay to CSMC any Royalties due hereunder at the applicable rate during the pendency of such action.  Should the outcome of an action described in the first sentence of this Section 4.2(c) determine that any contested claim of a patent challenged by Licensee, the Affiliate or the Sublicensee is valid and infringed and enforceable against a Product, Licensee or the Affiliate or Sublicensee bringing the challenge, as applicable, will thereafter (i) pay to CSMC the Royalties due hereunder at the rate of [***] the applicable rate for all Products sold that would infringe such claim; and (ii) reimburse CSMC for all costs actually incurred by CSMC in connection with the applicable legal proceedings.  In the event that a challenge of Patent Rights brought by Licensee, an Affiliate or a Sublicensee is partially or entirely successful, Licensee, the Affiliate and the Sublicensee will have no right to recoup any Royalties or other amounts paid before or during the period of the challenge.  Notwithstanding anything to the contrary, this Section 4.2(c), above, shall not apply with respect to challenges that arise in connection with any arguments, or any other statements or allegations, made by or on behalf of Licensee, its Affiliate or any Sublicensee that (A) distinguish the inventions claimed in patents or patent applications owned or controlled (except by virtue of this Agreement) by Licensee, its Affiliate or any Sublicensee from those claimed in the Patent Rights (1) in the ordinary course of prosecution of such patents or patent applications owned or controlled by Licensee, its Affiliate or any Sublicensee, including any reissue or reexamination patents or patent applications or (2) in inter partes, post grant review proceedings, oppositions, nullity proceedings, reissue proceedings, reexamination  proceedings, and other similar proceedings before the U.S. Patent and Trademark Office or other agency or tribunal in any jurisdiction, or in any arbitration or litigation, wherein such patents or patent applications owned or controlled by Licensee, its Affiliate or any Sublicensee have been challenged; and/or (B) challenge the validity, scope or enforceability of any Patent Right (1) as the result of a breach of CSMC’s representations, warranties or obligations hereunder, (2) as a result of any inequitable conduct of any individual associated with the filing and/or Prosecution of the application for such Patent Right, and/or (3) pursuant to a petition to the relevant governmental authority, made with the written approval of CSMC, in order to request the re-examination or re-issuance of a Patent Right in the course of maintaining such Patent Right.  Notwithstanding anything to the contrary, this Section 4.2(c), above, shall not apply with respect to any patent challenges that arise in connection with any agreements, or any other statements or allegations, made by or on behalf of Licensee, its Affiliate or any Sublicensee after Licensee ceases to maintain its original license rights to such Patent Right (e.g., as a result of the termination or expiration of this Agreement).

(d)Arm’s-Length Transactions.  On sales of Products which are made in other than an arms’-length transaction, the value of the Net Sales attributed under this Section 4.2

 

15


 

to such a transaction shall be that which would have been received in an arms’-length transaction, based on sales of like quality and quantity products on or about the time of such transaction.

(e)Duration of Royalty Obligations.  The royalty obligations of Licensee as to each Product shall terminate on a country-by-country and Product-by-Product basis on the later of: (1) for any Product that infringes on a Valid Claim, concurrently with the last to expire of a Valid Claim that covers such Product, including any term extensions thereof, and (2) for any Product that does not infringe on a Valid Claim, ten (10) years from the date of First Commercial Sale of such Product in the applicable country (each, a “Royalty Term”).  

(f)Payment and Accounting.

(i)Reports. Each payment of Royalties shall be accompanied by a report in the form attached as Schedule D of this Agreement, which sets forth in reasonable detail the number and each type of Product sold and the calculation of Net Sales applicable thereto, and such additional details as may be reasonably requested by CSMC for the determination of Royalties payable hereunder.  Products shall be considered as being sold for the purpose of the calculation of Royalties under this Agreement as of the earlier of (a) the date on which the gross amounts for the sale of such Products are actually received, or (b) the date that is [***] days after the Products have been invoiced.  Royalties shall be payable by Licensee quarterly, within [***] days after the end of each calendar quarter, based upon revenues accrued (in accordance with the foregoing sentence) during the immediately preceding calendar quarter.  All copies of reports under this Section 4.2(f)(i) shall be sent by electronic mail to [***].  Except as otherwise provided herein, all amounts due hereunder shall be paid in United States dollars and shall be made without set off and free and clear of (and without any deduction or withholding for) any taxes, duties, levies, imposts or similar fees or charges. Licensee agrees to pay and shall pay to CSMC, or cause its Sublicensees to pay to CSMC, all Royalties resulting from the activities of its Sublicensees, within [***] days after the end of each calendar quarter.  

(ii)Wire Transfer Instructions.  All payments due hereunder shall be made by Licensee to CSMC in accordance with the following wire transfer instructions:

[***]

(iii)Records and Audits.  Licensee shall create and maintain complete and accurate records and documentation concerning all sales of Products by Licensee, its Affiliates and Sublicensees, in sufficient detail to enable the Royalties that are payable hereunder to be determined.  Licensee shall retain such records and documentation for not less than [***] years from the date of their creation.  During the Agreement Term and for a period of [***] years thereafter, CSMC and its representatives shall have the right to audit such records and documentation as shall pertain to the determination and payment of.  Such examiners shall have reasonable access during regular business hours to Licensee’s offices and the relevant records, files and books of account, and shall have the right to examine any other records reasonably necessary to determine the accuracy of the calculations provided by Licensee.  The costs of any such audit shall be borne by CSMC, unless as a result of such inspection it is determined that the amounts payable by Licensee for any period are in error by greater than [***], in which case the costs of such audit shall be borne by Licensee.  CSMC shall report the results of any such audit to Licensee within [***] days of completion.  Thereafter, Licensee agrees it shall promptly pay to

 

16


 

CSMC the amount of any underpayment discovered in such audit, or CSMC shall credit to Licensee against future Royalty payments the amount of any overpayment discovered in such audit, as the case may be.  In addition, Licensee shall pay interest on any underpayment at the rate that is the lower of (i) [***] over the rate of interest announced by Bank of America in Los Angeles, California (or any successor in interest thereto or any commercially equivalent financial institution if no such successor exists) to be its “prime rate”, or (ii) the highest rate permitted by applicable law, from the date such amount was underpaid to the date payment is actually received.

(iv)Currency Transfer Restrictions. If any restrictions on the transfer of currency exist in any country or other jurisdiction so as to prevent Licensee from making payments to CSMC, Licensee shall take all commercially reasonable steps to obtain a waiver of such restrictions or to otherwise enable Licensee to make such payments.  If Licensee is unable to do so, Licensee shall make such payments to CSMC in a bank account or other depository designated by CSMC in such country or jurisdiction, which payments shall be in the local currency of such country or jurisdiction, unless payment in United States dollars is permitted.  Any payment by Licensee to CSMC in currencies other than United States dollars shall be calculated using the appropriate foreign exchange rate for such currency quoted in the California edition of The Wall Street Journal for the close of business of the last banking day of the calendar quarter in which such payment is being made.

(v)Late Charges.  A service charge at the rate that is the lower of (i) [***] over the rate of interest announced by Bank of America in Los Angeles, California (or any successor in interest thereto or any commercially equivalent financial institution if no such successor exists) to be its “prime rate”, or (ii) the highest rate permitted by applicable law, shall be payable by Licensee on any portion of Licensee’s outstanding undisputed amounts payable by Licensee hereunder that are not paid to CSMC within [***] days past the due date.

(vi)Taxes.  Licensee shall pay, or cause to be paid, any and all taxes required to be paid or withheld on any sales, licenses or other transfers for value of Products or Patent Rights (other than taxes imposed on the income or revenues of CSMC).  Licensee shall secure and send to CSMC proof of any such taxes withheld and paid by Licensee, its Affiliates or Sublicensees.

5.

Patent Rights

5.1Prosecution.  Subject to Section 4.2(c), commencing on the Effective Date and continuing until the termination of the Agreement, Licensee shall assume, in coordination with CSMC through the JSC, full responsibility for, and shall use Commercially Reasonable Efforts to pursue, the application, maintenance, reexamination, reissue, opposition and prosecution of any kind (collectively “Prosecution”) relating to the Patent Rights, including, but not limited to, payment of all costs, fees and expenses related thereto.  Subject to the approval of CSMC (which approval shall not be unreasonably withheld), Licensee shall have the right to select counsel with respect to the responsibility assumed by Licensee in this Section 5.1.  For all purposes of the patent Prosecution, CSMC shall be the named “client” of such patent counsel.  Each party shall provide the other with copies of any and all material or communications with the United States Patent and Trademark Office, or any foreign patent office, and CSMC and Licensee shall be afforded the opportunity of prior review and comment on such action or paper.

 

17


 

(a)Foreign Filings.  Should Licensee elect not to file for patent protection for the Patent Rights in a certain national jurisdiction in the Territory, Licensee shall notify the JSC of such election (with a copy to CSMC’s Technology Transfer Office by electronic mail at [***]) at least [***] days before a final due date which would result in the bar of patent protection for the Patent Rights in such national jurisdiction. In such event, CSMC may, at its sole option and expense, file for patent protection for the Patent Rights in the applicable national jurisdiction, and Licensee’s license under this Agreement with respect to such national jurisdiction shall terminate, allowing CSMC to freely dispose of its Patent Rights in the applicable national jurisdiction as it sees fit in its sole discretion, and such patent shall no longer be deemed to be Patent Rights for purposes of this Agreement.    

(b)Abandonment, Disclaimers, etc.  Licensee shall obtain the prior written consent of CSMC (which consent shall not be unreasonably withheld), prior to abandoning, disclaiming, withdrawing, seeking reissue, seeking reexamination or allowing to lapse any patent or patent application within the Patent Rights.  In the event that Licensee shall elect to abandon the Prosecution (including the payment of maintenance fees or annuities) of any patent or patent application included in the Patent Rights, Licensee shall notify CSMC of such election at least [***] days before a final due date which would result in abandonment or bar of patentability of the patent or patent application.  In such event, CSMC may, at its sole option and expense, continue Prosecution of the patent application or patent; the patent application or patent shall no longer be deemed part of the Patent Rights under this Agreement; and all rights in the patent application or patent shall revert to CSMC.  Licensee further agrees that it shall not file any continuation-in-part application relating to the Patent Rights without the prior written consent of CSMC, not to be unreasonably withheld, delayed, or conditioned, unless the additional disclosure or material to be included in the continuation-in-part application is necessary or appropriate to support the patentability of a claim recited in a parent application on which the continuation-in-part application is based.

5.2Expenses.  Except as otherwise expressly set forth herein, Licensee shall pay all expenses resulting from its obligations in Section 5.1 hereof.  CSMC shall exercise reasonable efforts to cause the Inventors (to the extent they are available and on CSMC’s staff as employees) to cooperate fully with Licensee with respect to the Prosecution of the Patent Rights, and CSMC shall be reimbursed for all reasonable out‑of‑pocket expenses as such expenses are incurred.

5.3CREATE Act.  Licensee shall not invoke the Cooperative Research and Technology Enhancement Act of 2004, as set forth under Title 35, Section 102(c) of the United States Code (the “CREATE Act”), with respect to the Patent Rights without first obtaining the prior written consent of CSMC.  

5.4Patent Schedule.  Schedule A of this Agreement shall be updated under the direction of the JSC from time to time, but not less frequently than [***], upon mutual agreement of the parties hereto, such agreement not to be unreasonably withheld, delayed, or conditioned, to include (a) Patent Rights filed on new Related Inventions; (b) changes to the patents and/or patent applications set forth on Schedule A of this Agreement made in the ordinary course of prosecution and maintenance of such patents and/or patent applications; and (c) subject to the provisions set forth in Section 2.3 of this Agreement, any Future Patent Rights which the parties have agreed

 

18


 

pursuant to good faith negotiations to add to this Agreement.  Each such update shall be made in writing, executed by duly authorized representatives of each of the parties hereto.  

6.

Term And Termination

6.1Term.  Unless earlier terminated as provided in Section 6.2 hereof, the term of this Agreement shall commence on the Effective Date and shall expire, on a country-by-country basis, upon the last to expire Royalty Term (the “Agreement Term”).  Upon the expiration of this Agreement in accordance with this Section 6.1 (but not the earlier termination of this Agreement in accordance with Section 6.2), the license set forth in Section 2.1 shall become fully paid-up, irrevocable, and perpetual, provided that, in the event that Licensee breaches any of its surviving obligations under this Agreement as set forth in Section 13.13, then such license may be terminated by CSMC in accordance with Section 6.2(c).

6.2Termination.  Except as provided by Section 6.3 and/or 6.8 hereof, this Agreement shall terminate upon the earliest to occur of the following:

(a)Automatically if Licensee shall enter into a liquidating bankruptcy, be adjudged insolvent, liquidate, dissolve and/or if the business of Licensee shall be placed in the hands of a receiver, assignee, or trustee, whether by voluntary act of Licensee or otherwise; provided, however, that, if any such action is involuntary, termination shall not take place unless the action is not reversed within [***] days.  Further, Licensee shall give CSMC at least [***] days’ prior written notice before Licensee initiates any bankruptcy proceeding, and CSMC shall have the right to terminate this Agreement immediately upon receipt of such notice;

(b)Upon [***] days written notice of CSMC to Licensee if the performance by either party to this Agreement of any term, covenant, condition or provision hereof (i) shall jeopardize (A) the licensure of CSMC, (B) CSMC’s participation in the Medicare, Medi-Cal or other reimbursement or payment programs, (C) the full accreditation of CSMC by The Joint Commission or any other state or nationally recognized accreditation organization, or (D) CSMC’s tax-exempt status; or (ii) is deemed illegal or unethical by any recognized governmental agency or body.  Upon the occurrence of any of the items set forth in this subparagraph (b), CSMC shall provide written notice to Licensee setting forth the reason for such termination and the parties shall promptly discuss in good faith reasonable means of avoiding such termination, including without limitation any required amendments to this Agreement, provided that, if termination cannot be avoided, such termination shall be effected at the end of such [***] day period;

 

(c)Upon [***] days’ written notice from CSMC if, within such [***] day period, Licensee shall fail to cure fully any breach or default of any material obligation under this Agreement as described in such written notice detailing the facts of such breach with reasonable specificity, which breach or default may include, without limitation, Licensee’s failure to use Commercially Reasonable Efforts to develop and make Products commercially available to the public in accordance with Section 2.4; provided, however, that Licensee may avoid such termination if, before the end of such [***]-day period, such breach or default has been cured by

 

19


 

Licensee; and provided further that this termination right shall not apply to breaches of Section 4.2(c), the exclusive remedy for which is set forth therein;

(d)Upon [***] days’ written notice from Licensee if, within such [***] day period, CSMC shall fail to cure fully any breach or default of any material obligation under this Agreement as described in such written notice detailing the facts of such breach with reasonable specificity; provided, however, that CSMC may avoid such termination if, before the end of such [***] day period, such breach or default has been cured by CSMC;

(e)By Licensee upon [***] days’ written notice to CSMC in the event that Licensee has determined that it would not be commercially reasonable to continue to develop and/or commercialize Products, including without limitation as a result of: (i) failure to secure adequate capital commitment within a commercially reasonable timeframe; (ii) failure to initiate a Phase I, Phase II or Phase III clinical trial for at least [***] Product within a commercially reasonable timeframe due to the following reasons: (A) regulatory restrictions, prohibitions, or adverse decisions; (B) lack of sufficient funding to complete the clinical trials and/or obtain supplies of Products; (C) lack of interest from clinical investigators; or (D) difficulties in patient accrual; (iii) scientific or technical reasons; (iv) the approved labeling for the Product; (v) competitive products then being developed and/or commercialized; (v) manufacturing concerns, including costs of goods and materials; (vi) intellectual property protection; (vii) obligations imposed by regulatory authorities; and (viii) pricing concerns; provided that, such written notice to CSMC under this Section 6.2(e) must provide CSMC with a reasonable explanation for Licensee’s termination under this Section 6.2(e).

(f)Upon the mutual written agreement of the parties hereto (such termination to be effective as of the date mutually agreed upon in such written agreement).

6.3Obligations Upon Termination. Upon any termination of this Agreement pursuant to Section 6.2 hereof, nothing herein shall be construed to release any party from any liability for any obligation incurred through the effective date of termination (e.g., confidentiality, reimbursement of patent expenses incurred prior to such date, etc.) or for any breach of this Agreement prior to the effective date of such termination.  Licensee may, for a period of [***] year after the effective date of such termination, sell all tangible Products customarily classified as “inventory” that it has on hand at the date of termination, subject to payment by Licensee to CSMC of the applicable Royalty; provided, however, that any such action by Licensee does not subject CSMC to any of the occurrences set forth in Section 6.2(b) hereof.

6.4Effect of Termination.  In the event of any termination of this Agreement pursuant to Section 6.2, where such termination has not been caused by any action or inaction on the part of any Sublicensee of Licensee or by any breach by such Sublicensee of its obligations under its sublicense from Licensee, such termination shall be without prejudice to the rights of each non‑breaching Sublicensee of Licensee and each non‑breaching Sublicensee shall be deemed to be a licensee of CSMC under this Agreement, as applicable, at such Sublicensee’s written request, and CSMC shall be entitled to all rights and subject to all obligations under this Agreement (to the extent provided for in such sublicense).  This Section 6.4, however, shall not be applicable if this Agreement has been terminated under Section 6.2(b) under circumstances where the application of this Section 6.4 would subject CSMC to any of the occurrences set forth in Section 6.2(b).

 

20


 

6.5Right to Institute Legal Actions. Notwithstanding the provisions of Section 6.2 hereof, CSMC, on the one hand, and Licensee, on the other hand, may institute any other legal action or pursue any other remedy against the other party permitted by applicable law if the other party does not substantially cure any breach or default of any material obligation as provided herein.

6.6Reversion of Rights. Notwithstanding anything to the contrary set forth herein (including, but not limited to, Section 5 hereof), full responsibility for Prosecution of the terminated Patent Rights shall, at CSMC’s sole expense from the date of reversion, revert to CSMC upon any termination of this Agreement.

6.7Return of Data.  In the event of any termination or expiration of this Agreement, Licensee shall, upon the request of CSMC, negotiate in good faith with CSMC for a reasonable period regarding the terms and conditions under which CSMC would receive copies of data, information and materials obtained or generated by or on behalf of Licensee in the course of conducting research and developing Products using the Patent Rights and the Technology.

6.8Dispute.  If either party reasonably and in good faith disagrees as to whether the other party has a basis for terminating this Agreement pursuant to Section 6.2, the non-terminating party may contest the allegation in accordance with Section 13.3.  During the pendency of such a dispute, all of the terms and conditions of this Agreement shall remain in effect, and the parties shall continue to perform all of their respective obligations and retain their respective rights under this Agreement.  

7.

Infringement By Third Parties

The parties agree as follows:

7.1Enforcement. The parties shall notify each other in writing of any suspected or actual infringement of any Patent Rights by a third party and shall provide the other party with any available evidence thereof.  After such notification, CSMC and Licensee shall consult for a period not to exceed [***] days whether enforcement of the Patent Rights by Licensee against such third party infringer is reasonably warranted, by determining whether a reasonably prudent licensee would institute litigation to enforce the patent in question in light of all relevant business and economic factors (including, but not limited to, the projected cost of such litigation, the likelihood of success on the merits, the probable amount of any damage award, the prospects for satisfaction of any judgment against the alleged infringer, the possibility of counterclaims against the parties hereto, the impact of any possible adverse outcome on Licensee and the effect any publicity might have on the parties’ respective reputations and goodwill).  If, upon the expiration of such [***] day period, it is mutually determined by the parties that a suit should be filed by Licensee, Licensee shall have the right and the obligation to enforce, at its sole expense, the Patent Rights against infringement by such third party infringer.  If, upon the expiration of such [***] day period, the parties have not agreed that a suit should be filed by Licensee, Licensee shall have the right, but not the obligation, to enforce, at its sole expense, the Patent Rights against infringement by such third party infringer or commence settlement negotiations with respect thereto.  Upon Licensee’s undertaking to pay all expenditures reasonably incurred by CSMC, CSMC shall reasonably cooperate in any such enforcement and, as necessary, join as a party therein.  Licensee shall reimburse CSMC for all expenses, including reasonable attorneys’ fees, incurred in connection with any such enforcement.  In the event that Licensee does not file suit against or commence

 

21


 

settlement negotiations with the infringer within [***] days of the expiration of the [***] day consultation period described above, then CSMC shall have the right, at its own expense, to enforce the Patent Rights licensed hereunder on behalf of itself and Licensee.  Any damages or other recovery from an infringement action undertaken by Licensee shall first be used to reimburse the parties, on a pro rata pari passu basis, for the costs and expenses incurred in such action, and shall thereafter be allocated between the parties as follows: (a) [***] to Licensee and (b) [***] to CSMC.  If Licensee fails to prosecute any such action to completion, then any damages or other recovery from an infringement action undertaken or assumed by CSMC shall first be used to reimburse the parties, on a pro rata pari passu basis, for the costs and expenses incurred in such action, and shall thereafter be allocated between the parties as follows: (a) [***] to CSMC and (b) [***] to Licensee.  

7.2Defense Of Patent Rights. In the event that any Patent Rights are the subject of a legal action seeking declaratory relief or of any reexamination or opposition proceeding instituted by a third party, the parties agree to promptly consult with each other concerning the defense of such actions or proceedings.  If the parties agree that such defense should be undertaken, then Licensee shall bear the expenses, including attorneys’ fees, associated with such defense and in any recoupment of expenses.  If the parties disagree, then the party desiring to defend the action or proceeding may proceed with such defense and will bear its own expenses, and be entitled to all sums recovered.

8.

Indemnification

8.1Indemnification by Licensee. Subject to Section 8.2 hereof, Licensee shall hold harmless, defend and indemnify CSMC and each of its officers, directors, employees (including the Inventors), and agents (each, an “Indemnified Party”, and collectively, the “Indemnified Parties”) from and against any and all claims, damages, losses, liabilities, costs and expenses (including reasonable attorneys’ fees and expenses) suffered or incurred by any of the Indemnified Party in any action, suit, litigation, arbitration or dispute of any kind brought by a third party (“Action”) arising or resulting from any negligence or willful acts or omissions on the part of Licensee, its Affiliates or Sublicensees in connection with (a) their use of the Patent Rights or Technology and/or (b) the exercise of their rights hereunder or under any sublicense, including, but not limited to (i) the preclinical development and clinical testing of Products, and (ii) the manufacture, sale, use, marketing, or other disposition of Products developed, manufactured, sold, marketed, used or otherwise disposed of under this Agreement; except to the extent any of the foregoing arise out of or result from (i) CSMC’s breach of any covenant, obligation, representation or warranty under this Agreement and/or (ii) the negligent or willful acts or omissions of any Indemnified Party.

8.2Indemnification Procedure.  CSMC shall promptly notify Licensee in writing of any claim or Action or material threat thereof brought against any Indemnified Party in respect of which indemnification may be sought and, to the extent allowed by applicable law, shall reasonably cooperate with Licensee in defending or settling any such claim or Action (at Licensee’s expense).  Subject to this Section 8, Licensee shall defend any Action brought by a third party against any of the Indemnified Parties for which Licensee is obligated to indemnify pursuant to Section 8.1, provided that Licensee shall have the sole right to control the defense and/or settlement of any such Action with counsel of Licensee’s own choosing and reasonably acceptable to CSMC.  No settlement of any Action against the Indemnified Party for which CSMC intends to seek indemnification (for itself or on behalf of any other Indemnified Party) shall be

 

22


 

made without the prior joint written approval of Licensee and CSMC, which approval shall not be unreasonably withheld, delayed, or conditioned by either party, provided that Licensee shall have the right to settle any Action without the need to obtain CSMC’s approval, if such settlement is solely monetary in nature and admits no wrongdoing on the part of CSMC or the Indemnified Party.  If CSMC or any other Indemnified Party does not permit Licensee to exclusively control the defense of any such Action, or if CSMC or any other Indemnified Party does not obtain the approval of Licensee to settle such Action, Licensee shall have no obligation to defend or indemnify the CSMC or any other Indemnified Party hereunder.  

8.3 Insurance. Licensee shall obtain and maintain insurance policies (including products liability and general liability policies at such time as is appropriate) which are reasonable and necessary to cover its activities and to comply with the indemnification obligations set forth above.  Such insurance policies shall name CSMC as an additional insured party and shall provide a minimum of $[***] in coverage per occurrence, and $[***] in the aggregate.  Upon initiation of any human clinical studies of Diagnostic Products, Licensee shall have first increased its insurance coverage to a minimum of $[***] in the aggregate, and upon initiation of any human clinical studies of Therapeutic Products, Licensee shall have first increased its insurance coverage to a minimum of $[***] in the aggregate.  Licensee shall provide CSMC with prompt written notice of any material change in coverage under such policies.  If the parties determine that evidence of Licensee’s insurance coverage is necessary and appropriate, within [***] days of the Effective Date (subject to extension if reasonably required) and annually thereafter, Licensee shall provide CSMC with a certificate of insurance issued by the appropriate insurance company evidencing the insurance coverage required by this Section 8.3, together with copies of the endorsement which specifies CSMC as an additional insured and the declarations page for each such insurance policy.  The certificate of insurance, endorsements and declarations pages (and any renewals or replacements thereof), if required, shall be sent to CSMC’s Technology Transfer Office by electronic mail at [***].  

9.

Use Of Names

9.1CSMC Names and Marks.  Licensee shall not, unless as required by any law or governmental regulation, use the name of CSMC, and/or any of its trademarks, service marks, trade names or fictitious business names or the name of any CSMC officer, faculty member, employee, student or volunteer (collectively, “CSMC Names and Marks”) without express prior written consent of the Vice President for Public Relations and Marketing of CSMC.  Further, except as otherwise required by applicable law, prior to any reference by Licensee to CSMC Names and Marks in any manner, Licensee shall provide CSMC with a writing reflecting the proposed reference so that CSMC can review the reference within a reasonable period of time prior to the proposed use thereof by Licensee.  Except as otherwise required by applicable law, including the rules and regulations of the Securities and Exchange Commission, this limitation includes, but is not limited to, use by Licensee in any regulatory filing, advertising, offering circular, prospectus, sales presentation, news release or trade publication.  In addition, certain specific language may be mutually agreed upon by the parties for Licensee’s use in certain contexts and with respect to certain topics, and once agreed upon, may be utilized by Licensee in connection with the approved contexts and topics without further permission of the applicable Licensor.  Subject to compliance by Licensee with the foregoing, which shall be deemed conditions precedent to any use of CSMC Names and Marks by Licensee, Licensee shall ensure that the CSMC Names and Marks are used

 

23


 

as scientifically or academically appropriate in the “byline” of any article, abstract, manuscript or any other publication related to the subject matter hereof.

9.2No Endorsements by CSMC.  By entering into this Agreement, CSMC does not directly or indirectly endorse any product or service provided, or to be provided, by Licensee whether directly or indirectly related to this Agreement. Licensee shall not state or imply that this Agreement is an endorsement by CSMC.

10.

Confidentiality

10.1Non-Disclosure.  The parties hereto shall keep the terms of this Agreement and all business and scientific discussions relating to the business of the parties confidential except as otherwise set forth in this Agreement.  All patient information to which a party is given access by the other party shall be subject to the provisions of the Confidentiality of Medical Information Act (Cal. Civ. Code §§56, et seq.) and the Health Insurance Portability and Accountability Act of 1996, and all regulations promulgated thereunder.  It may, from time to time, be necessary for the parties, in connection with performance under this Agreement, to disclose Confidential Information (including know-how) to each other.  The Receiving Party (as defined in Section 1.3 hereof) shall keep in confidence the Confidential Information of the Disclosing Party (as defined in Section 1.3 hereof), using the standard of care it normally uses for information of like character, and shall not disclose the Confidential Information to any third party or use it except as expressly authorized by the prior written consent of the Disclosing Party or as otherwise permitted by this Agreement.  Notwithstanding the foregoing, (a) Licensee may disclose the Confidential Information received from CSMC, and also may provide a copy of this Agreement, to its Affiliates, officers, directors, employees, accountants, attorneys, consultants, agents, and potential or actual Sublicensees as shall be reasonably necessary to carry out the intent of this Agreement or any sublicense granted by Licensee as contemplated by this Agreement and (b) Licensee may provide a copy of this Agreement to its Affiliates, officers, directors, employees, accountants, attorneys, consultants, agents, and potential or actual Sublicensees, investors, acquirers, lenders, or other financial partners, for purposes of a potential business transaction or obtaining professional advice, if, but only if, with respect to each of (a) and (b) above, (i) such entity or person is subject to confidentiality obligations no less restrictive than those confidentiality provisions contained in this Section 10 and (ii) Licensee shall be fully responsible and liable for any action of such third party recipient which would constitute a breach of this Agreement if committed by Licensee as if Licensee had committed such action itself.  Furthermore, Licensee may include a copy of this Agreement in legally required regulatory filings; provided that Licensee will seek confidential treatment of all financial terms of this Agreement in all such legally required regulatory filings.  The Receiving Party’s obligations hereunder shall not apply to Confidential Information that the Receiving Party can show:

(a)Is or later becomes part of the public domain through no fault or neglect of the Receiving Party;

(b)Is received in good faith from a third party having no obligations of confidentiality to the Disclosing Party, provided that the Receiving Party complies with any restrictions imposed by the third party;

 

24


 

(c)Is independently developed by the Receiving Party without use of the Disclosing Party’s Confidential Information; or

(d)Is required by law or regulation to be disclosed (including, without limitation, in connection with FDA filings, filings with another government agency or as required under the California Public Records Act), provided that the Receiving Party uses reasonable efforts to restrict disclosure and to obtain confidential treatment.

10.2Limits on Permitted Disclosures.  Each party agrees that any disclosure or distribution of the other party’s Confidential Information within its own organization shall be made only as is reasonably necessary to carry out the intent of this Agreement.  The parties further agree that all of their respective officers, employees, agents, representatives or approved sublicensees to whom any Confidential Information is disclosed or distributed shall have agreed to maintain its confidentiality.  

10.3Legally Required Disclosures.  If a subpoena or other legal process concerning Confidential Information is served upon any party hereto pertaining to the subject matter hereof, the party served shall notify the other party immediately, the other party shall cooperate with the party served, at the other party’s expense, in any effort to contest the validity of such subpoena or other legal process.  This Section 10.3 shall not be construed in any way to limit any party’s ability to satisfy any disclosure of its relationship with the other party required by any governmental authority.

10.4Patent Rights and Technology as Confidential Information.  The Patent Rights are understood by Licensee to be the Confidential Information of CSMC to the extent “unpublished” as such term is construed under the United States Patent Laws.  As such, Licensee’s confidentiality obligations hereunder automatically extend to any and all Technology and to any and all patent applications of CSMC relating to any Patent Rights, and to any and all communications with the United States Patent and Trademark Office, and any foreign patent office relating to any Patent Rights.

10.5Return of Confidential Information.  In the event of any termination of this Agreement, the Receiving Party shall promptly return all Confidential Information and any copies made thereof previously made available to the Receiving Party by the Disclosing Party.

10.6Remedies.  Both parties acknowledge and agree that it would be difficult to measure damages for breach by either party of the covenants set forth in this Section 10, and that injury from any such breach would be incalculable, and that money damages would therefore be an inadequate remedy for any such breach.  Accordingly, either party shall be entitled, in addition to all other remedies available hereunder or under law or equity, to injunctive or such other equitable relief as a court may deem appropriate to restrain or remedy any breach of such covenants.

10.7Term of Confidentiality.  The obligations of confidentiality and nonuse set forth in this Section 10 shall survive for a period of [***] years beyond the termination or expiration of this Agreement.

11.

Information Exchange

 

25


 

In addition to the Patent Rights and Technology, the parties shall cooperate to exchange such non‑confidential information as may be appropriate and necessary to facilitate Licensee’s development and commercialization of Products incorporating any Patent Rights or Technology.

12.

Patent Marking

Licensee shall use Commercially Reasonable Efforts to actually or virtually mark all Products made, sold or otherwise disposed of by or on behalf of it or any of its Affiliates and Sublicensees as set forth under Title 35, Section 287(a) of the United States Code and shall respond to any request or disclosure under Title 35, Section 287(b)(4)(B) of the United States Code by only notifying CSMC of the request for disclosure.

13.

Miscellaneous

13.1Notices. Any notice, request, instruction or other document required by this Agreement shall be in writing and shall be deemed to have been given (a) if mailed with the United States Postal Service by prepaid, first class, certified mail, return receipt requested, at the time of receipt by the intended recipient, or (b) if sent by Federal Express or other overnight carrier, signature of delivery required, at the time of receipt by the intended recipient, addressed as follows:

In the case of CSMC to:

Cedars-Sinai Medical Center
8700 Beverly Boulevard
Los Angeles, California  90048-1865
Attention:  Executive Vice President for Finance & Treasurer

with a copy to Vice President, Intellectual Property

or in the case of Licensee to:

Prometheus Biosciences, Inc.

9410 Carroll Park Drive

San Diego, California 92121

Attention: Chief Executive Officer

with a copy to General Counsel

or to such other address or to such other person(s) as may be given from time to time under the terms of this Section 13.1.

13.2Compliance with Laws. Each party shall comply with all applicable federal, state and local laws and regulations in connection with its activities pursuant to this Agreement.

13.3Dispute Resolution.

(a)Governing Law.  For any dispute between the parties to this Agreement which arises from or relates to this Agreement (“Dispute”), the Agreement shall be construed and

 

26


 

enforced in accordance with the laws of the United States of America and of the State of California, irrespective of choice of laws provisions.

(b)Arbitration.  The parties shall settle any Dispute by submitting the matter to binding arbitration to be held in Los Angeles, California, if Licensee initiates such arbitration, and in San Diego, California, if CSMC initiates such arbitration, in accordance with the Commercial Arbitration Rules of the American Arbitration Association.  The arbitration shall be held in the English language. In any such arbitration, the arbitrator shall be appointed by agreement of both parties or, if no agreement can be reached, by the American Arbitration Association pursuant to its rules, which arbitrator, in each case, shall be an experienced lawyer or judge (or retired lawyer or judge).  The decision of the arbitrator shall be final and binding on all parties to this Agreement, and judgment upon the award may be entered in any court having jurisdiction.  All or a portion of the costs of the arbitration proceeding, including attorneys’ fees, may be awarded by the arbitrator to the party against whom the arbitrator rules.

13.4Waiver. Failure of any party to enforce a right under this Agreement shall not act as a waiver of that right or the ability to assert that right relative to the particular situation involved.

13.5Enforceability. If any provision of this Agreement shall be found by a court of competent jurisdiction to be void, invalid or unenforceable, the same shall be reformed to comply with applicable law or stricken if not so conformable, so as not to affect the validity or enforceability of the remainder of this Agreement.

13.6Modification. No change, modification, or addition or amendment to this Agreement, or waiver of any term or condition of this Agreement, is valid or enforceable unless in writing and signed and dated by the authorized officers of the parties to this Agreement.

13.7Entire Agreement. This Agreement and the Schedules hereto (which are incorporated herein by this reference as if fully set forth herein) constitute the entire agreement between the parties with respect to the subject matter hereof and thereof, and replace and supersede as of the date hereof and thereof any and all prior or contemporaneous agreements and understandings, whether oral or written, between the parties with respect to the subject matter of such agreements.  

13.8Construction. This Agreement has been prepared, examined, negotiated and revised by each party and their respective attorneys, and no implication shall be drawn and no provision shall be construed against any party to this Agreement by virtue of the purported identity of the drafter of this Agreement or any portion thereof.

13.9Counterparts. This Agreement may be executed simultaneously in one or more counterparts, each of which shall constitute one and the same instrument.  This Agreement may be executed in .pdf format.

13.10Attorneys’ Fees. In the event of any action at law or in equity between the parties hereto to enforce any of the provisions hereof, the unsuccessful party to such litigation shall pay to the successful party all reasonable costs and expenses, including reasonable attorneys’ fees, incurred therein by such successful party; and if such successful party shall recover a judgment in

 

27


 

any such action or proceeding, such reasonable costs, expenses and attorneys’ fees may be included in and as part of such judgment.

13.11Assignment; Successors.

(a)Neither this Agreement, nor any of the rights or obligations of a party may be assigned, in whole or in part, without the prior written consent of the other party, which consent may not be unreasonably withheld, delayed, or conditioned; provided, however, that either party may assign this Agreement, without the obligation to obtain the prior written consent of the other party, to an Affiliate, and, subject to Section 13.11(b), Licensee may transfer or assign this Agreement, without the obligation to obtain the prior written consent of CSMC, as part of a sale, regardless of whether such a sale occurs through an asset sale, stock sale, merger or other combination, or any other transfer of Licensee’s entire business, or that part of Licensee’s business that exercises all rights granted under this Agreement; and provided further that CSMC shall have the right to assign this Agreement, without the obligation to obtain the prior written consent of Licensee, as part of any reorganization or bond financing.  Any attempt to transfer or assign this Agreement by either party that is inconsistent with this Section 13.11(a), above, shall be null and void.  In the event of a bankruptcy, assignment is permitted only to a party that can provide adequate assurance of future performance, including diligent development and sales, of Products.  

(b)Prior to any assignment, the new assignee must agree in writing to CSMC to be bound by this Agreement.

(c)Subject to the limitations on assignment herein, this Agreement shall be binding upon and inure to the benefit of any successors in interest and assigns of CSMC and Licensee.  

(d)Notwithstanding anything to the contrary herein, Licensee shall be permitted to pledge and grant a security interest in any of Licensee’s rights, licenses and interests under this Agreement and upon any foreclosure of such security interest, Licensee’s rights, licenses and interests under this Agreement shall inure to the benefit of the holder of such security interest.  For the avoidance of doubt, Licensee shall have no right to pledge or grant a security interest in any of CSMC’s property or assets, including without limitation, the Patent Rights, Technology or MIRIAD Biobank.

13.12Further Assurances. At any time and from time to time after the Effective Date, each party shall do, execute, acknowledge and deliver, and cause to be done, executed, acknowledged or delivered, all such further acts, transfers, conveyances, assignments or assurances as may be reasonably required to consummate the transactions contemplated by this Agreement.

13.13Survival. The following sections shall survive any expiration or earlier termination of this Agreement:  4.2, 6.4, 6.5, 8, 9, 10 (for the period set forth in Section 10.7), 12 and 13.

[signature page follows]

 

 

28


 

 

In Witness Whereof, the parties have caused their duly authorized representatives to execute this Agreement as of the date first above written.

 

“LICENSEE”:

 

 

Prometheus Biosciences, Inc.,

a Delaware corporation

 

 

By:

/s/ Mark McKenna

Mark McKenna

President & Chief Executive Officer

 

Date:  August 6, 2021

 

 

 

 

“CSMC”:

 

 

 

Cedars-Sinai Medical Center,

a California nonprofit public benefit corporation

 

 

By:

/s/ Edward M. Prunchunas

Edward M. Prunchunas

Executive Vice President, Finance & Treasurer

 

Date:  August 6, 2021

 

 

By:

/s/ Nirdesh Gupta

Nirdesh K. Gupta, Ph.D.

Executive Director, Technology and Venture Affairs

 

 

Date:  August 5, 2021

 

 


 

 

Schedule A

Patent Rights

[***]

 

 

Exhibit 31.1

CERTIFICATION PURSUANT TO

RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Mark C. McKenna, certify that:

1.

I have reviewed this Quarterly Report on Form 10-Q, of Prometheus Biosciences, Inc.;

2.

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

3.

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

4.

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

 

(a)

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

 

(b)

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

 

(c)

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

 

(d)

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

5.

The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

 

(a)

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

 

(b)

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

 

Date:  August 11, 2021

 

By:

/s/ Mark C. McKenna

 

 

 

Mark C. McKenna

 

 

 

President and Chief Executive Officer

 

 

 

Exhibit 31.2

CERTIFICATION PURSUANT TO

RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Keith W. Marshall, Ph.D., certify that:

1.

I have reviewed this Quarterly Report on Form 10-Q, of Prometheus Biosciences, Inc.;

2.

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

3.

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

4.

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

 

(a)

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

 

(b)

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

 

(c)

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

 

(d)

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

5.

The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

 

(a)

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

 

(b)

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

 

Date: August 11, 2021

 

By:

/s/ Keith W. Marshall, Ph.D.

 

 

 

Keith W. Marshall, Ph.D.

 

 

 

Chief Financial Officer

 

 

 

Exhibit 32.1

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Prometheus Biosciences, Inc. (the “Company”) on Form 10-Q for the period ending June 30, 2021, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

 

(1)

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

 

(2)

The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.

 

Date: August 11, 2021

 

By:

 

/s/ Mark C. McKenna

 

 

 

 

Mark C. McKenna

 

 

 

 

President and Chief Executive Officer

 

 

 

Exhibit 32.2

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Prometheus Biosciences, Inc. (the “Company”) on Form 10-Q for the period ending June 30, 2021, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

 

(1)

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

 

(2)

The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.

 

Date: August 11, 2021

 

By:

 

/s/ Keith W. Marshall, Ph.D.

 

 

 

 

Keith W. Marshall, Ph.D.

 

 

 

 

Chief Financial Officer