10-Q
Q2--12-310001832038false0001832038us-gaap:TreasuryStockMember2022-12-310001832038us-gaap:InProcessResearchAndDevelopmentMember2022-01-012022-06-300001832038us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2022-12-310001832038us-gaap:ResearchAndDevelopmentExpenseMember2023-04-012023-06-300001832038us-gaap:FairValueInputsLevel3Memberivvd:FederalAgencySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2023-06-300001832038us-gaap:EmployeeStockOptionMember2023-01-012023-06-300001832038ivvd:MithrilGroupMember2023-06-300001832038ivvd:EquityIncentivePlanMember2023-01-012023-06-300001832038us-gaap:FairValueInputsLevel3Memberus-gaap:USTreasurySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2022-12-3100018320382023-02-012023-02-2800018320382023-04-012023-06-3000018320382022-01-012022-03-310001832038us-gaap:AdditionalPaidInCapitalMember2022-03-310001832038ivvd:TwoThousandAndTwentyOneEmployeeStockPurchasePlanMembersrt:MaximumMember2023-01-012023-06-300001832038us-gaap:TreasuryStockMember2022-09-300001832038us-gaap:RetainedEarningsMember2022-12-310001832038ivvd:TheScrippsResearchInstituteMember2023-01-012023-06-300001832038us-gaap:RetainedEarningsMember2023-03-310001832038us-gaap:CommonStockMember2022-01-012022-03-310001832038us-gaap:CommonStockMember2021-12-310001832038us-gaap:TreasuryStockMember2022-06-300001832038ivvd:AdimabAssignmentAgreementMembersrt:MaximumMember2023-01-012023-06-300001832038ivvd:AAndRCommercialManufacturingAgreementMember2022-04-300001832038us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-01-012023-03-310001832038srt:MaximumMemberivvd:TwoThousandsTwentyOneEquityIncentivePlanMember2021-07-310001832038ivvd:PopulationHealthPartnersMember2023-04-012023-06-300001832038ivvd:TwoThousandAndTwentyTwoEmployeeStockPurchasePlanMember2023-06-300001832038us-gaap:AccumulatedOtherComprehensiveIncomeMember2021-12-310001832038us-gaap:FairValueInputsLevel3Memberus-gaap:CashAndCashEquivalentsMemberivvd:FederalAgencySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2023-06-300001832038ivvd:AdimabMember2023-06-300001832038ivvd:FifteenNovemberTwoThousandTwentyNineMemberivvd:PhpWarrantMember2023-01-012023-06-300001832038us-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMember2023-06-300001832038us-gaap:CommonStockMember2022-03-310001832038us-gaap:TreasuryStockMember2022-06-302022-06-300001832038ivvd:AdimabCollaborationAgreementMember2022-04-012022-06-300001832038us-gaap:TreasuryStockMember2023-03-012023-03-3100018320382021-09-140001832038us-gaap:InProcessResearchAndDevelopmentMember2023-01-012023-06-300001832038us-gaap:FairValueInputsLevel1Memberus-gaap:CashAndCashEquivalentsMemberivvd:FederalAgencySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2023-06-300001832038us-gaap:FairValueInputsLevel2Memberus-gaap:USTreasurySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2022-12-310001832038us-gaap:ResearchAndDevelopmentExpenseMember2023-01-012023-06-300001832038ivvd:AdimabCollaborationAgreementMember2023-04-012023-06-300001832038ivvd:AAndRCommercialManufacturingAgreementMember2023-06-300001832038ivvd:PopulationHealthPartnersMember2022-11-300001832038us-gaap:GeneralAndAdministrativeExpenseMember2023-01-012023-06-300001832038us-gaap:FairValueInputsLevel2Memberus-gaap:CashAndCashEquivalentsMemberivvd:FederalAgencySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2023-06-3000018320382022-01-012022-06-300001832038us-gaap:TreasuryStockMember2022-02-282022-02-2800018320382022-03-310001832038us-gaap:FairValueInputsLevel3Memberus-gaap:USTreasurySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2023-06-300001832038us-gaap:FairValueInputsLevel1Memberus-gaap:USTreasurySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2022-12-310001832038us-gaap:AdditionalPaidInCapitalMember2023-03-310001832038ivvd:PhpWarrantsOutstandingMember2023-06-300001832038ivvd:ResearchDevelopmentAndRegulatoryMilestoneMemberivvd:AdimabPlatformTransferAgreementMember2023-01-012023-06-300001832038us-gaap:EmployeeStockOptionMember2023-01-012023-06-300001832038us-gaap:RetainedEarningsMember2022-03-310001832038us-gaap:ResearchAndDevelopmentExpenseMember2022-01-012022-06-300001832038srt:MaximumMember2023-06-300001832038us-gaap:ResearchAndDevelopmentExpenseMember2022-04-012022-06-300001832038us-gaap:FairValueInputsLevel1Memberivvd:FederalAgencySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2023-06-3000018320382022-11-300001832038us-gaap:ConvertiblePreferredStockMember2022-01-012022-06-300001832038us-gaap:TreasuryStockMember2021-12-3100018320382022-06-302022-06-300001832038ivvd:AdimabAssignmentAgreementMemberus-gaap:ResearchAndDevelopmentExpenseMember2022-01-012022-06-300001832038ivvd:AdimabMember2022-12-310001832038ivvd:FederalAgencySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2022-12-310001832038us-gaap:USTreasurySecuritiesMember2023-01-012023-06-300001832038us-gaap:USTreasurySecuritiesMember2022-01-012022-12-3100018320382023-06-012023-06-300001832038us-gaap:ResearchAndDevelopmentExpenseMemberivvd:AdimabCollaborationAgreementMember2022-01-012022-06-300001832038ivvd:AdimabAssignmentAgreementMemberus-gaap:ResearchAndDevelopmentExpenseMember2022-04-012022-06-3000018320382022-12-310001832038ivvd:AdimabCollaborationAgreementMember2022-01-012022-06-300001832038us-gaap:ResearchAndDevelopmentExpenseMemberivvd:AdimabCollaborationAgreementMember2022-04-012022-06-300001832038us-gaap:EmployeeStockOptionMemberivvd:TwoThousandsTwentyOneEquityIncentivePlanMember2023-06-300001832038us-gaap:GeneralAndAdministrativeExpenseMember2022-04-012022-06-300001832038ivvd:PhpWarrantsOutstandingMember2023-04-012023-06-300001832038us-gaap:FairValueInputsLevel1Memberus-gaap:CashAndCashEquivalentsMemberus-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2023-06-300001832038ivvd:TwoThousandAndTwentyOneEmployeeStockPurchasePlanMember2023-06-300001832038us-gaap:EmployeeStockOptionMember2023-04-012023-06-300001832038ivvd:PhpMember2023-06-3000018320382021-07-310001832038us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-12-310001832038ivvd:AdimabAssignmentAgreementMemberus-gaap:ResearchAndDevelopmentExpenseMember2023-04-012023-06-300001832038us-gaap:GeneralAndAdministrativeExpenseMember2022-01-012022-06-300001832038ivvd:AdimabAssignmentAgreementMemberivvd:SecondProductMember2020-07-012020-07-310001832038ivvd:AdimabAssignmentAgreementMembersrt:MaximumMemberus-gaap:ResearchAndDevelopmentExpenseMember2023-04-012023-06-300001832038ivvd:TwoThousandsTwentyOneEquityIncentivePlanMember2022-01-012022-01-010001832038us-gaap:ResearchAndDevelopmentArrangementMember2022-01-012022-06-300001832038us-gaap:RetainedEarningsMember2022-01-012022-03-310001832038us-gaap:AdditionalPaidInCapitalMember2023-01-012023-03-310001832038us-gaap:ResearchAndDevelopmentArrangementMember2023-01-012023-06-3000018320382022-04-300001832038us-gaap:CashAndCashEquivalentsMemberus-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2023-06-300001832038us-gaap:ResearchAndDevelopmentArrangementMember2023-04-012023-06-300001832038us-gaap:TreasuryStockMember2022-03-310001832038us-gaap:RetainedEarningsMember2023-04-012023-06-300001832038us-gaap:FairValueInputsLevel3Memberus-gaap:CashAndCashEquivalentsMemberus-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2023-06-300001832038ivvd:PhpWarrantsOutstandingMember2022-11-012022-11-300001832038ivvd:TwoThousandAndTwentyOneEmployeeStockPurchasePlanMembersrt:MaximumMember2023-04-012023-06-300001832038us-gaap:FairValueInputsLevel3Memberus-gaap:MoneyMarketFundsMemberus-gaap:CashAndCashEquivalentsMemberus-gaap:FairValueMeasurementsRecurringMember2022-12-310001832038us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-04-012023-06-300001832038us-gaap:EmployeeStockOptionMember2022-01-012022-06-3000018320382021-12-310001832038ivvd:TheScrippsResearchInstituteMember2023-04-012023-06-300001832038ivvd:VydTwoHundredTwentyTwoDrugsubstanceMember2023-06-300001832038ivvd:FederalAgencySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2023-06-3000018320382023-08-0300018320382022-09-282022-09-280001832038us-gaap:USTreasurySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2023-06-300001832038us-gaap:AdditionalPaidInCapitalMember2022-06-300001832038ivvd:AdimabAssignmentAgreementMembersrt:MaximumMemberus-gaap:ResearchAndDevelopmentExpenseMember2023-01-012023-06-300001832038us-gaap:FairValueInputsLevel1Memberus-gaap:CashAndCashEquivalentsMemberus-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2022-12-310001832038ivvd:TheScrippsResearchInstituteMember2021-08-012021-08-310001832038us-gaap:AdditionalPaidInCapitalMember2021-12-310001832038ivvd:AdimabPlatformTransferAgreementMember2023-01-012023-06-300001832038ivvd:AdimabAssignmentAgreementMember2022-01-012022-12-310001832038us-gaap:FairValueInputsLevel1Memberivvd:FederalAgencySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2022-12-310001832038us-gaap:FairValueMeasurementsRecurringMember2022-12-310001832038us-gaap:TreasuryStockMember2023-04-012023-06-300001832038us-gaap:CommonStockMember2022-12-310001832038us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2023-06-300001832038us-gaap:InProcessResearchAndDevelopmentMember2022-04-012022-06-3000018320382023-01-012023-06-300001832038ivvd:TwoThousandsTwentyOneEquityIncentivePlanMember2021-07-310001832038us-gaap:AdditionalPaidInCapitalMember2023-04-012023-06-300001832038us-gaap:GeneralAndAdministrativeExpenseMember2023-04-012023-06-300001832038us-gaap:RetainedEarningsMember2021-12-310001832038ivvd:TwoThousandsTwentyOneEquityIncentivePlanMember2023-06-300001832038us-gaap:ResearchAndDevelopmentExpenseMemberivvd:AdimabCollaborationAgreementMember2023-04-012023-06-300001832038ivvd:AdimabAssignmentAgreementMember2023-01-012023-03-310001832038us-gaap:FairValueInputsLevel2Memberivvd:FederalAgencySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2023-06-300001832038us-gaap:FairValueInputsLevel2Memberus-gaap:CashAndCashEquivalentsMemberus-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2022-12-310001832038us-gaap:RestrictedStockMember2023-01-012023-06-300001832038ivvd:AdimabAssignmentAgreementMembersrt:MaximumMember2020-07-012020-07-310001832038ivvd:TwoThousandAndTwentyOneEmployeeStockPurchasePlanMember2021-07-310001832038ivvd:FourHundredOneKPlanMember2022-04-012022-06-300001832038ivvd:AdimabAssignmentAgreementMemberus-gaap:ResearchAndDevelopmentExpenseMember2023-01-012023-06-300001832038us-gaap:RetainedEarningsMember2023-06-300001832038ivvd:FourHundredOneKPlanMember2023-04-012023-06-300001832038ivvd:ResearchDevelopmentAndRegulatoryMilestoneMember2023-01-012023-06-300001832038ivvd:AdimabAssignmentAgreementMemberivvd:InProcessResearchAndDevelopmentExpenseMember2023-04-012023-06-300001832038ivvd:FifteenNovemberTwoThousandThirtyMemberivvd:PhpWarrantMember2023-01-012023-06-300001832038ivvd:PhpMemberus-gaap:ResearchAndDevelopmentExpenseMember2023-01-012023-06-3000018320382021-07-012021-07-310001832038ivvd:TheScrippsResearchInstituteMember2022-04-012022-06-300001832038us-gaap:FairValueInputsLevel2Memberivvd:FederalAgencySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2022-12-3100018320382023-01-012023-03-310001832038ivvd:ADG20DrugSubstanceMember2023-06-300001832038us-gaap:FairValueInputsLevel2Memberus-gaap:MoneyMarketFundsMemberus-gaap:CashAndCashEquivalentsMemberus-gaap:FairValueMeasurementsRecurringMember2023-06-300001832038ivvd:TwoThousandAndTwentyEmployeeStockPurchasePlanMember2023-06-300001832038us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-03-3100018320382022-06-300001832038us-gaap:AdditionalPaidInCapitalMember2022-12-310001832038us-gaap:CommonStockMember2022-06-300001832038ivvd:FirstProductMemberivvd:AdimabAssignmentAgreementMember2020-07-012020-07-310001832038ivvd:PhpMemberus-gaap:ResearchAndDevelopmentExpenseMember2023-04-012023-06-300001832038us-gaap:TreasuryStockMember2023-05-312023-05-310001832038ivvd:MithrilGroupMemberus-gaap:ResearchAndDevelopmentExpenseMember2022-01-012022-12-310001832038us-gaap:ConvertiblePreferredStockMember2023-01-012023-06-300001832038ivvd:PopulationHealthPartnersMember2023-01-012023-06-3000018320382023-03-310001832038us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-01-012022-03-310001832038us-gaap:FairValueMeasurementsRecurringMember2023-06-300001832038us-gaap:FairValueInputsLevel2Memberus-gaap:USTreasurySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2023-06-300001832038us-gaap:EmployeeStockOptionMember2022-04-012022-06-300001832038us-gaap:TreasuryStockMember2022-04-012022-06-300001832038us-gaap:ResearchAndDevelopmentArrangementMember2022-04-012022-06-300001832038us-gaap:RetainedEarningsMember2022-04-012022-06-300001832038us-gaap:CommonStockMember2023-03-310001832038ivvd:EquityIncentivePlanMembersrt:MinimumMember2023-01-012023-06-300001832038ivvd:EquityIncentivePlanMember2023-06-300001832038ivvd:TheScrippsResearchInstituteMember2022-01-012022-06-300001832038us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2023-06-300001832038us-gaap:FairValueInputsLevel1Memberus-gaap:USTreasurySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2023-06-300001832038ivvd:AAndRCommercialManufacturingAgreementMemberus-gaap:SubsequentEventMemberivvd:VydTwoHundredTwentyTwoDrugsubstanceMember2023-07-310001832038ivvd:TwoThousandsTwentyOneEquityIncentivePlanMember2021-07-012021-07-310001832038us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-06-300001832038us-gaap:CommonStockMember2023-04-012023-06-3000018320382022-09-302022-09-300001832038us-gaap:CommonStockMember2022-04-012022-06-300001832038us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-06-300001832038us-gaap:AdditionalPaidInCapitalMember2022-01-012022-03-310001832038ivvd:PopulationHealthPartnersMember2023-06-300001832038srt:MaximumMember2022-12-310001832038ivvd:AdimabPlatformTransferAgreementMember2023-04-012023-06-300001832038us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2022-12-310001832038us-gaap:CommonStockMember2023-06-300001832038ivvd:WuXiCellLineLicenseAgreementMember2023-04-012023-06-300001832038us-gaap:TreasuryStockMember2023-06-3000018320382022-01-012022-12-310001832038us-gaap:TreasuryStockMember2022-01-012022-03-310001832038us-gaap:TreasuryStockMember2023-03-310001832038ivvd:FourHundredOneKPlanMember2023-01-012023-06-300001832038ivvd:AdimabAssignmentAgreementMemberivvd:InProcessResearchAndDevelopmentExpenseMember2023-01-012023-06-300001832038us-gaap:RetainedEarningsMember2022-06-300001832038us-gaap:RetainedEarningsMember2023-01-012023-03-310001832038us-gaap:AccumulatedOtherComprehensiveIncomeMember2023-03-3100018320382022-04-012022-06-300001832038us-gaap:AgencySecuritiesMember2023-01-012023-06-300001832038ivvd:FifteenNovemberTwoThousandTwentyEightMemberivvd:PhpWarrantMember2023-01-012023-06-300001832038ivvd:AdimabAssignmentAgreementMember2023-01-012023-06-3000018320382023-06-300001832038ivvd:AdimabCollaborationAgreementMember2023-01-012023-06-300001832038ivvd:FourHundredOneKPlanMember2022-01-012022-06-300001832038us-gaap:CashAndCashEquivalentsMemberivvd:FederalAgencySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2023-06-300001832038ivvd:PhpWarrantsOutstandingMember2022-11-300001832038ivvd:PhpWarrantsOutstandingMember2023-01-012023-06-300001832038us-gaap:EmployeeStockOptionMember2022-01-012022-06-300001832038ivvd:TwoThousandAndTwentyEmployeeStockPurchasePlanMemberus-gaap:EmployeeStockOptionMember2023-06-300001832038us-gaap:RestrictedStockMember2022-01-012022-06-300001832038us-gaap:USTreasurySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2022-12-3100018320382021-09-142021-09-140001832038us-gaap:MoneyMarketFundsMemberus-gaap:CashAndCashEquivalentsMemberus-gaap:FairValueMeasurementsRecurringMember2022-12-310001832038ivvd:WuXiCellLineLicenseAgreementMember2023-01-012023-06-300001832038us-gaap:FairValueInputsLevel3Memberus-gaap:FairValueMeasurementsRecurringMember2022-12-310001832038us-gaap:InProcessResearchAndDevelopmentMember2023-04-012023-06-300001832038us-gaap:AgencySecuritiesMember2022-01-012022-12-310001832038us-gaap:CommonStockMember2023-01-012023-03-310001832038us-gaap:ResearchAndDevelopmentExpenseMemberivvd:AdimabCollaborationAgreementMember2023-01-012023-06-300001832038us-gaap:AdditionalPaidInCapitalMember2023-06-300001832038us-gaap:FairValueInputsLevel3Memberivvd:FederalAgencySecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2022-12-310001832038us-gaap:TreasuryStockMember2023-01-012023-03-310001832038ivvd:AdimabAssignmentAgreementMembersrt:MinimumMember2023-01-012023-06-300001832038us-gaap:AdditionalPaidInCapitalMember2022-04-012022-06-30xbrli:pureutr:sqftxbrli:sharesivvd:Installmentiso4217:USDxbrli:sharesiso4217:USD

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

(Mark One)

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

For the quarterly period ended June 30, 2023

OR

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

For the transition period from ___________________ to ___________________

Commission File Number: 001-40703

 

INVIVYD, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

85-1403134

(State or other jurisdiction of

incorporation or organization)

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

1601 Trapelo Road, Suite 178
Waltham, MA

02451

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (781) 819-0080

 

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

 

IVVD

 

The Nasdaq Global Market

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

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

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

 

Large accelerated filer

 

Accelerated filer

 

 

 

 

Non-accelerated filer

 

Smaller reporting company

 

 

 

 

 

 

 

 

 

 

 

Emerging growth company

 

 

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

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

As of August 3, 2023, the registrant had 109,755,624 shares of common stock, $0.0001 par value per share, outstanding.

 

 


Table of Contents

Page

PART I.

FINANCIAL INFORMATION

1

Item 1.

Financial Statements (Unaudited)

1

Condensed Consolidated Balance Sheets

1

Condensed Consolidated Statements of Operations and Comprehensive Loss

2

Condensed Consolidated Statements of Stockholders’ Equity (Deficit)

3

Condensed Consolidated Statements of Cash Flows

5

Notes to Unaudited Condensed Consolidated Financial Statements

6

Item 2.

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

25

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

38

Item 4.

Controls and Procedures

38

PART II.

OTHER INFORMATION

39

Item 1.

Legal Proceedings

39

Item 1A.

Risk Factors

39

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

39

Item 5.

Other Information

39

Item 6.

Exhibits

40

Signatures

41

 

i


PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

INVIVYD, INC.

Condensed Consolidated Balance Sheets

(UNaudited)

(In thousands, except share and per share amounts)

 

 

June 30,
2023

 

 

December 31,
2022

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

121,947

 

 

$

92,076

 

Marketable securities

 

 

176,483

 

 

 

279,915

 

Prepaid expenses and other current assets

 

 

11,556

 

 

 

4,926

 

Total current assets

 

 

309,986

 

 

 

376,917

 

Property and equipment, net

 

 

2,123

 

 

 

2,282

 

Operating lease right-of-use assets

 

 

3,014

 

 

 

3,777

 

Other non-current assets

 

 

291

 

 

 

191

 

Total assets

 

$

315,414

 

 

$

383,167

 

Liabilities, Preferred Stock and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

4,112

 

 

$

1,517

 

Accrued expenses

 

 

26,744

 

 

 

21,911

 

Operating lease liabilities, current

 

 

1,611

 

 

 

1,559

 

Other current liabilities

 

 

38

 

 

 

44

 

Total current liabilities

 

 

32,505

 

 

 

25,031

 

Operating lease liabilities, non-current

 

 

1,346

 

 

 

2,165

 

Early-exercise liability

 

 

 

 

 

1

 

Total liabilities

 

 

33,851

 

 

 

27,197

 

Commitments and contingencies (Note 9)

 

 

 

 

 

 

Stockholders’ equity (deficit):

 

 

 

 

 

 

        Preferred stock (undesignated), $0.0001 par value; 10,000,000 shares
           authorized and
no shares issued and outstanding at June 30, 2023
           and December 31, 2022

 

 

 

 

 

 

        Common stock, $0.0001 par value; 1,000,000,000 shares authorized,
           
109,570,333 shares issued and outstanding at June 30, 2023;
           
109,044,046 shares issued and outstanding at December 31, 2022

 

 

11

 

 

 

11

 

Additional paid-in capital

 

 

900,549

 

 

 

889,657

 

Accumulated other comprehensive loss

 

 

(22

)

 

 

(272

)

Accumulated deficit

 

 

(618,975

)

 

 

(533,426

)

Total stockholders’ equity

 

 

281,563

 

 

 

355,970

 

Total liabilities, preferred stock and stockholders’ equity

 

$

315,414

 

 

$

383,167

 

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

1


INVIVYD, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(UNaudited)

(In thousands, except share and per share amounts)

 

 

Three Months Ended June 30,

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development(1)

 

$

43,618

 

 

$

37,129

 

 

$

70,819

 

 

$

129,164

 

Acquired in-process research and development(2)

 

 

150

 

 

 

 

 

 

975

 

 

 

 

Selling, general and administrative

 

 

10,107

 

 

 

14,620

 

 

 

21,152

 

 

 

23,324

 

Total operating expenses

 

 

53,875

 

 

 

51,749

 

 

 

92,946

 

 

 

152,488

 

Loss from operations

 

 

(53,875

)

 

 

(51,749

)

 

 

(92,946

)

 

 

(152,488

)

Other income:

 

 

 

 

 

 

 

 

 

 

 

 

Other income

 

 

3,647

 

 

 

759

 

 

 

7,397

 

 

 

832

 

Total other income

 

 

3,647

 

 

 

759

 

 

 

7,397

 

 

 

832

 

Net loss

 

 

(50,228

)

 

 

(50,990

)

 

 

(85,549

)

 

 

(151,656

)

Other comprehensive income (loss)

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain on available-for-sale securities, net of tax

 

 

93

 

 

 

 

 

 

250

 

 

 

8

 

Comprehensive loss

 

$

(50,135

)

 

$

(50,990

)

 

$

(85,299

)

 

$

(151,648

)

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

 

$

(0.46

)

 

$

(0.47

)

 

$

(0.78

)

 

$

(1.40

)

Weighted-average common shares outstanding, basic and diluted

 

 

109,450,071

 

 

 

108,166,890

 

 

 

109,119,630

 

 

 

108,019,051

 

(1)
Includes related-party amounts of $2,258 and $5,218 for the three and six months ended June 30, 2023, respectively, and $2,285 and $4,285 for the three and six months ended June 30, 2022, respectively (see Note 15).
(2)
Includes related-party amounts of $0 and $375 for the three and six months ended June 30, 2023, respectively, and includes no related-party amounts for both the three and six months ended June 30, 2022 (see Note 15).

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

2


 

INVIVYD, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)

(UNAUDITED)

(In thousands, except share amounts)

 

 

 

Common Stock

 

 

Treasury Stock

 

 

Additional
Paid-in

 

 

Accumulated Other Comprehensive

 

 

Accumulated

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity (Deficit)

 

Balances at December 31, 2021

 

 

110,782,909

 

 

$

11

 

 

 

468,751

 

 

$

 

 

$

850,125

 

 

$

(8

)

 

$

(292,109

)

 

$

558,019

 

Vesting of restricted common stock from early-exercised options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1

 

 

 

 

 

 

 

 

 

1

 

Exercise of stock options

 

 

50,353

 

 

 

 

 

 

 

 

 

 

 

 

47

 

 

 

 

 

 

 

 

 

47

 

Repurchase of unvested restricted common stock

 

 

(1,158,089

)

 

 

 

 

 

1,158,089

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Retirement of treasury stock

 

 

 

 

 

 

 

 

(1,626,840

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,983

 

 

 

 

 

 

 

 

 

1,983

 

Unrealized gain on available-for-sale securities, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8

 

 

 

 

 

 

8

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(100,666

)

 

 

(100,666

)

Balances at March 31, 2022

 

 

109,675,173

 

 

$

11

 

 

 

 

 

$

 

 

$

852,156

 

 

$

 

 

$

(392,775

)

 

$

459,392

 

Exercise of stock options

 

 

98,000

 

 

 

 

 

 

 

 

 

 

 

 

76

 

 

 

 

 

 

 

 

 

76

 

Repurchase of unvested restricted common stock

 

 

(992,648

)

 

 

 

 

 

992,648

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6,361

 

 

 

 

 

 

 

 

 

6,361

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(50,990

)

 

 

(50,990

)

Balances at June 30, 2022

 

 

108,780,525

 

 

 

11

 

 

 

992,648

 

 

 

 

 

 

858,593

 

 

 

 

 

 

(443,765

)

 

 

414,839

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

 

Treasury Stock

 

 

Additional
Paid-in

 

 

Accumulated Other Comprehensive

 

 

Accumulated

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity (Deficit)

 

Balances at December 31, 2022

 

 

109,044,046

 

 

$

11

 

 

 

 

 

$

 

 

$

889,657

 

 

$

(272

)

 

$

(533,426

)

 

$

355,970

 

Vesting of restricted common stock from early-exercised options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1

 

 

 

 

 

 

 

 

 

1

 

Exercise of stock options

 

 

423,203

 

 

 

 

 

 

 

 

 

 

 

 

459

 

 

 

 

 

 

 

 

 

459

 

Repurchase of unvested restricted common stock

 

 

(206,802

)

 

 

 

 

 

206,802

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Retirement of treasury stock

 

 

 

 

 

 

 

 

(206,802

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5,400

 

 

 

 

 

 

 

 

 

5,400

 

Issuance of common stock under the employee stock purchase plan

 

 

55,779

 

 

 

 

 

 

 

 

 

 

 

 

83

 

 

 

 

 

 

 

 

 

83

 

Unrealized gain on available-for-sale securities, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

157

 

 

 

 

 

 

157

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(35,321

)

 

 

(35,321

)

Balances at March 31, 2023

 

$

109,316,226

 

 

$

11

 

 

$

 

 

$

 

 

$

895,600

 

 

$

(115

)

 

$

(568,747

)

 

$

326,749

 

Vesting of restricted common stock from early-exercised options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1

 

 

 

 

 

 

 

 

 

1

 

Exercise of stock options

 

 

255,440

 

 

 

 

 

 

 

 

 

 

 

 

215

 

 

 

 

 

 

 

 

 

215

 

Repurchase of unvested restricted common stock

 

 

(46,600

)

 

 

 

 

 

46,600

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Retirement of treasury stock

 

 

 

 

 

 

 

 

(46,600

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4,677

 

 

 

 

 

 

 

 

 

4,677

 

Issuance of common stock under the employee stock purchase plan

 

 

45,267

 

 

 

 

 

 

 

 

 

 

 

 

56

 

 

 

 

 

 

 

 

 

56

 

Unrealized gain on available-for-sale securities, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

93

 

 

 

 

 

 

93

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(50,228

)

 

 

(50,228