false Q2 0000949858 --12-31 P30D P3Y P1Y P3Y P1Y P3Y P1Y P1Y P7Y true P4Y P4Y P5Y11M26D P5Y11M23D 0000949858 2021-01-01 2021-06-30 xbrli:shares 0000949858 2021-08-12 iso4217:USD xbrli:shares 0000949858 achv:SeriesBConvertiblePreferredStockMember 2021-06-30 0000949858 achv:SeriesBConvertiblePreferredStockMember 2020-12-31 0000949858 2021-06-30 0000949858 2020-12-31 0000949858 achv:SeriesAConvertiblePreferredStockMember 2021-06-30 0000949858 achv:SeriesAConvertiblePreferredStockMember 2020-12-31 iso4217:USD 0000949858 2021-04-01 2021-06-30 0000949858 2020-04-01 2020-06-30 0000949858 2020-01-01 2020-06-30 0000949858 achv:AprilTwoThousandTwentyPrivatePlacementMember 2020-01-01 2020-06-30 0000949858 achv:DecemberTwoThousandNineteenPublicOfferingMember 2020-01-01 2020-06-30 0000949858 achv:May2021PublicOfferingMember 2021-01-01 2021-06-30 0000949858 achv:LincolnParkCapitalFundLimitedLiabilityCompanyMember achv:PurchaseAgreementMember 2020-01-01 2020-06-30 0000949858 2019-12-31 0000949858 2020-06-30 0000949858 us-gaap:CommonStockMember 2020-12-31 0000949858 us-gaap:CommonStockIncludingAdditionalPaidInCapitalMember 2020-12-31 0000949858 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2020-12-31 0000949858 us-gaap:RetainedEarningsMember 2020-12-31 0000949858 us-gaap:CommonStockIncludingAdditionalPaidInCapitalMember 2021-01-01 2021-03-31 0000949858 2021-01-01 2021-03-31 0000949858 us-gaap:CommonStockMember 2021-01-01 2021-03-31 0000949858 us-gaap:RetainedEarningsMember 2021-01-01 2021-03-31 0000949858 us-gaap:CommonStockMember 2021-03-31 0000949858 us-gaap:CommonStockIncludingAdditionalPaidInCapitalMember 2021-03-31 0000949858 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2021-03-31 0000949858 us-gaap:RetainedEarningsMember 2021-03-31 0000949858 2021-03-31 0000949858 us-gaap:CommonStockIncludingAdditionalPaidInCapitalMember 2021-04-01 2021-06-30 0000949858 us-gaap:CommonStockMember 2021-04-01 2021-06-30 0000949858 us-gaap:CommonStockMember achv:May2021PublicOfferingMember 2021-04-01 2021-06-30 0000949858 us-gaap:CommonStockIncludingAdditionalPaidInCapitalMember achv:May2021PublicOfferingMember 2021-04-01 2021-06-30 0000949858 achv:May2021PublicOfferingMember 2021-04-01 2021-06-30 0000949858 us-gaap:RetainedEarningsMember 2021-04-01 2021-06-30 0000949858 us-gaap:CommonStockMember 2021-06-30 0000949858 us-gaap:CommonStockIncludingAdditionalPaidInCapitalMember 2021-06-30 0000949858 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2021-06-30 0000949858 us-gaap:RetainedEarningsMember 2021-06-30 0000949858 us-gaap:CommonStockMember 2019-12-31 0000949858 us-gaap:PreferredStockMember 2019-12-31 0000949858 us-gaap:CommonStockIncludingAdditionalPaidInCapitalMember 2019-12-31 0000949858 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2019-12-31 0000949858 us-gaap:RetainedEarningsMember 2019-12-31 0000949858 us-gaap:CommonStockIncludingAdditionalPaidInCapitalMember 2020-01-01 2020-03-31 0000949858 2020-01-01 2020-03-31 0000949858 us-gaap:CommonStockIncludingAdditionalPaidInCapitalMember achv:DecemberTwoThousandNineteenFinancingMember 2020-01-01 2020-03-31 0000949858 achv:DecemberTwoThousandNineteenFinancingMember 2020-01-01 2020-03-31 0000949858 us-gaap:CommonStockIncludingAdditionalPaidInCapitalMember achv:LincolnParkCapitalFundLLCMember 2020-01-01 2020-03-31 0000949858 achv:LincolnParkCapitalFundLLCMember 2020-01-01 2020-03-31 0000949858 us-gaap:CommonStockMember achv:SeriesBConvertiblePreferredStockMember 2020-01-01 2020-03-31 0000949858 us-gaap:PreferredStockMember achv:SeriesBConvertiblePreferredStockMember 2020-01-01 2020-03-31 0000949858 us-gaap:CommonStockIncludingAdditionalPaidInCapitalMember achv:SeriesBConvertiblePreferredStockMember 2020-01-01 2020-03-31 0000949858 us-gaap:RetainedEarningsMember 2020-01-01 2020-03-31 0000949858 us-gaap:CommonStockMember 2020-03-31 0000949858 us-gaap:CommonStockIncludingAdditionalPaidInCapitalMember 2020-03-31 0000949858 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2020-03-31 0000949858 us-gaap:RetainedEarningsMember 2020-03-31 0000949858 2020-03-31 0000949858 us-gaap:CommonStockIncludingAdditionalPaidInCapitalMember 2020-04-01 2020-06-30 0000949858 us-gaap:CommonStockIncludingAdditionalPaidInCapitalMember achv:LincolnParkCapitalFundLLCMember 2020-04-01 2020-06-30 0000949858 achv:LincolnParkCapitalFundLLCMember 2020-04-01 2020-06-30 0000949858 us-gaap:CommonStockMember 2020-04-01 2020-06-30 0000949858 us-gaap:CommonStockMember us-gaap:PrivatePlacementMember 2020-04-01 2020-06-30 0000949858 us-gaap:CommonStockIncludingAdditionalPaidInCapitalMember us-gaap:PrivatePlacementMember 2020-04-01 2020-06-30 0000949858 us-gaap:PrivatePlacementMember 2020-04-01 2020-06-30 0000949858 us-gaap:CommonStockMember us-gaap:ConvertiblePreferredStockMember 2020-04-01 2020-06-30 0000949858 us-gaap:CommonStockIncludingAdditionalPaidInCapitalMember us-gaap:ConvertiblePreferredStockMember 2020-04-01 2020-06-30 0000949858 us-gaap:RetainedEarningsMember 2020-04-01 2020-06-30 0000949858 us-gaap:CommonStockMember 2020-06-30 0000949858 us-gaap:CommonStockIncludingAdditionalPaidInCapitalMember 2020-06-30 0000949858 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2020-06-30 0000949858 us-gaap:RetainedEarningsMember 2020-06-30 0000949858 achv:VancouverOfficeOperatingLeaseMember 2021-01-01 2021-06-30 0000949858 2015-05-18 0000949858 2015-05-18 2015-05-18 0000949858 us-gaap:LicensingAgreementsMember 2021-06-30 0000949858 us-gaap:LicensingAgreementsMember 2020-12-31 0000949858 achv:UniversityOfBristolMember 2016-07-31 0000949858 achv:UniversityOfBristolMember achv:AmendmentToLicenseAgreementMember 2018-01-22 2018-01-22 0000949858 achv:UniversityOfBristolMember achv:AmendmentToLicenseAgreementMember 2018-01-22 0000949858 achv:UniversityOfBristolMember 2021-01-01 2021-06-30 0000949858 srt:MaximumMember 2021-01-01 2021-06-30 0000949858 us-gaap:MoneyMarketFundsMember us-gaap:FairValueInputsLevel1Member us-gaap:FairValueMeasurementsRecurringMember 2021-06-30 0000949858 us-gaap:MoneyMarketFundsMember us-gaap:FairValueMeasurementsRecurringMember 2021-06-30 0000949858 achv:RestrictedCashMember us-gaap:FairValueInputsLevel1Member us-gaap:FairValueMeasurementsRecurringMember 2021-06-30 0000949858 achv:RestrictedCashMember us-gaap:FairValueMeasurementsRecurringMember 2021-06-30 0000949858 us-gaap:FairValueInputsLevel1Member us-gaap:FairValueMeasurementsRecurringMember 2021-06-30 0000949858 us-gaap:FairValueMeasurementsRecurringMember 2021-06-30 0000949858 us-gaap:MoneyMarketFundsMember 2021-06-30 0000949858 achv:LincolnParkCapitalFundLimitedLiabilityCompanyMember 2020-03-12 xbrli:pure 0000949858 achv:LincolnParkCapitalFundLimitedLiabilityCompanyMember 2018-05-21 2018-05-22 0000949858 achv:LincolnParkCapitalFundLimitedLiabilityCompanyMember achv:UnitsMember 2017-09-12 2017-09-14 0000949858 achv:LincolnParkCapitalFundLimitedLiabilityCompanyMember achv:UnitsMember 2017-09-14 0000949858 achv:LincolnParkCapitalFundLimitedLiabilityCompanyMember achv:UnitsMember 2021-01-01 2021-06-30 0000949858 achv:LincolnParkCapitalFundLimitedLiabilityCompanyMember achv:OtherWarrantSharesMember 2017-09-14 0000949858 achv:LincolnParkCapitalFundLimitedLiabilityCompanyMember achv:PurchaseAgreementMember 2017-09-14 0000949858 achv:LincolnParkCapitalFundLimitedLiabilityCompanyMember 2017-09-14 0000949858 achv:LincolnParkCapitalFundLimitedLiabilityCompanyMember 2020-03-12 2020-03-12 0000949858 achv:LincolnParkCapitalFundLimitedLiabilityCompanyMember 2021-04-01 2021-06-30 0000949858 achv:LincolnParkCapitalFundLimitedLiabilityCompanyMember 2021-01-01 2021-06-30 0000949858 achv:LincolnParkCapitalFundLimitedLiabilityCompanyMember 2017-09-15 2021-06-30 0000949858 achv:LincolnParkCapitalFundLimitedLiabilityCompanyMember 2021-06-30 0000949858 us-gaap:PrivatePlacementMember 2020-04-27 2020-04-28 0000949858 us-gaap:PrivatePlacementMember 2020-04-28 0000949858 us-gaap:PrivatePlacementMember achv:PlacementAgentMember 2020-04-28 0000949858 us-gaap:PrivatePlacementMember achv:SubscriptionAgreementsExecutedOnAprilTwentySevenTwoThousandTwentyMember 2021-06-30 0000949858 us-gaap:PrivatePlacementMember achv:SubscriptionAgreementsExecutedOnAprilTwentyEightTwoThousandTwentyMember 2021-06-30 0000949858 us-gaap:PrivatePlacementMember 2021-01-01 2021-06-30 0000949858 achv:DirectOfferingMember us-gaap:CommonStockMember 2020-07-01 2020-07-01 0000949858 achv:DirectOfferingMember us-gaap:CommonStockMember 2020-07-01 0000949858 achv:DirectOfferingMember 2020-07-01 2020-07-01 0000949858 us-gaap:CommonStockMember achv:AugustTwoThousandTwentyPublicOfferingMember 2020-08-05 2020-08-06 0000949858 us-gaap:CommonStockMember us-gaap:OverAllotmentOptionMember 2020-08-05 2020-08-06 0000949858 achv:AugustTwoThousandTwentyPublicOfferingMember achv:PreFundedWarrantsMember 2020-08-06 0000949858 us-gaap:CommonStockMember achv:AugustTwoThousandTwentyPublicOfferingMember 2020-08-06 0000949858 us-gaap:CommonStockMember achv:AugustTwoThousandTwentyPublicOfferingMember achv:PreFundedWarrantsMember 2020-08-06 0000949858 achv:AugustTwoThousandTwentyPublicOfferingMember achv:PreFundedWarrantsMember us-gaap:CommonStockMember srt:MinimumMember 2020-08-05 2020-08-06 0000949858 achv:AugustTwoThousandTwentyPublicOfferingMember achv:PreFundedWarrantsMember us-gaap:CommonStockMember srt:MaximumMember 2020-08-05 2020-08-06 0000949858 achv:AugustTwoThousandTwentyPublicOfferingMember achv:PreFundedWarrantsMember us-gaap:CommonStockMember 2020-08-05 2020-08-06 0000949858 achv:AugustTwoThousandTwentyPublicOfferingMember 2020-08-05 2020-08-06 0000949858 us-gaap:CommonStockMember achv:DecemberTwoThousandTwentyPublicOfferingMember 2020-12-07 2020-12-07 0000949858 us-gaap:CommonStockMember us-gaap:OverAllotmentOptionMember 2020-12-07 2020-12-07 0000949858 us-gaap:CommonStockMember achv:DecemberTwoThousandTwentyPublicOfferingMember 2020-12-07 0000949858 achv:RepresentativesWarrantMember achv:DecemberTwoThousandTwentyPublicOfferingMember 2020-12-07 0000949858 achv:RepresentativesWarrantMember achv:DecemberTwoThousandTwentyPublicOfferingMember 2020-12-07 2020-12-07 0000949858 achv:DecemberTwoThousandTwentyPublicOfferingMember 2020-12-07 2020-12-07 0000949858 us-gaap:CommonStockMember achv:MayTwoThousandTwentyOnePublicOfferingMember 2021-05-27 2021-05-27 0000949858 us-gaap:CommonStockMember us-gaap:OverAllotmentOptionMember 2021-05-27 2021-05-27 0000949858 us-gaap:CommonStockMember achv:MayTwoThousandTwentyOnePublicOfferingMember 2021-05-27 0000949858 achv:MayTwoThousandTwentyOnePublicOfferingMember 2021-05-27 2021-05-27 0000949858 achv:TwoThousandAndEighteenEquityIncentivePlanMember us-gaap:EmployeeStockOptionMember 2021-06-30 0000949858 achv:TwoThousandAndEighteenEquityIncentivePlanMember 2021-06-30 0000949858 us-gaap:RestrictedStockUnitsRSUMember 2021-06-30 0000949858 achv:TwoThousandAndEighteenEquityIncentivePlanMember srt:MinimumMember achv:EmployeesAndConsultantsMember 2021-01-01 2021-06-30 0000949858 achv:TwoThousandAndEighteenEquityIncentivePlanMember srt:MaximumMember achv:EmployeesAndConsultantsMember 2021-01-01 2021-06-30 0000949858 achv:TwoThousandAndEighteenEquityIncentivePlanMember srt:MinimumMember achv:BoardOfDirectorsMember 2021-01-01 2021-06-30 0000949858 achv:TwoThousandAndEighteenEquityIncentivePlanMember srt:MaximumMember achv:BoardOfDirectorsMember 2021-01-01 2021-06-30 0000949858 achv:TwoThousandAndEighteenEquityIncentivePlanMember 2021-01-01 2021-06-30 0000949858 achv:TwoThousandsAndSeventeenEquityIncentivePlanMember us-gaap:EmployeeStockOptionMember 2021-06-30 0000949858 achv:TwoThousandsAndSeventeenEquityIncentivePlanMember achv:EmployeesAndConsultantsMember srt:MinimumMember 2021-01-01 2021-06-30 0000949858 achv:TwoThousandsAndSeventeenEquityIncentivePlanMember achv:EmployeesAndConsultantsMember srt:MaximumMember 2021-01-01 2021-06-30 0000949858 achv:TwoThousandsAndSeventeenEquityIncentivePlanMember achv:BoardOfDirectorsMember srt:MinimumMember 2021-01-01 2021-06-30 0000949858 achv:TwoThousandsAndSeventeenEquityIncentivePlanMember achv:BoardOfDirectorsMember srt:MaximumMember 2021-01-01 2021-06-30 0000949858 achv:TwoThousandsAndSeventeenEquityIncentivePlanMember 2021-01-01 2021-06-30 0000949858 achv:TwoThousandsAndTenPerformanceIncentivePlanMember us-gaap:EmployeeStockOptionMember 2021-06-30 0000949858 achv:TwoThousandsAndTenPerformanceIncentivePlanMember us-gaap:RestrictedStockUnitsRSUMember 2021-06-30 0000949858 achv:EmployeesAndConsultantsMember achv:TwoThousandsAndTenPerformanceIncentivePlanMember srt:MinimumMember 2021-01-01 2021-06-30 0000949858 achv:EmployeesAndConsultantsMember achv:TwoThousandsAndTenPerformanceIncentivePlanMember srt:MaximumMember 2021-01-01 2021-06-30 0000949858 achv:BoardOfDirectorsMember achv:TwoThousandsAndTenPerformanceIncentivePlanMember srt:MinimumMember 2021-01-01 2021-06-30 0000949858 achv:BoardOfDirectorsMember achv:TwoThousandsAndTenPerformanceIncentivePlanMember srt:MaximumMember 2021-01-01 2021-06-30 0000949858 achv:TwoThousandsAndTenPerformanceIncentivePlanMember 2021-01-01 2021-06-30 0000949858 us-gaap:EmployeeStockOptionMember achv:EmployeesAndConsultantsMember 2021-01-01 2021-06-30 0000949858 us-gaap:EmployeeStockOptionMember achv:BoardOfDirectorsMember srt:MinimumMember 2021-01-01 2021-06-30 0000949858 us-gaap:EmployeeStockOptionMember achv:BoardOfDirectorsMember srt:MaximumMember 2021-01-01 2021-06-30 0000949858 us-gaap:EmployeeStockOptionMember srt:MinimumMember 2021-01-01 2021-06-30 0000949858 us-gaap:EmployeeStockOptionMember srt:MaximumMember 2021-01-01 2021-06-30 0000949858 us-gaap:ResearchAndDevelopmentExpenseMember 2021-04-01 2021-06-30 0000949858 us-gaap:ResearchAndDevelopmentExpenseMember 2020-04-01 2020-06-30 0000949858 us-gaap:ResearchAndDevelopmentExpenseMember 2021-01-01 2021-06-30 0000949858 us-gaap:ResearchAndDevelopmentExpenseMember 2020-01-01 2020-06-30 0000949858 us-gaap:GeneralAndAdministrativeExpenseMember 2021-04-01 2021-06-30 0000949858 us-gaap:GeneralAndAdministrativeExpenseMember 2020-04-01 2020-06-30 0000949858 us-gaap:GeneralAndAdministrativeExpenseMember 2021-01-01 2021-06-30 0000949858 us-gaap:GeneralAndAdministrativeExpenseMember 2020-01-01 2020-06-30 0000949858 us-gaap:EmployeeStockOptionMember 2021-01-01 2021-06-30 0000949858 us-gaap:WarrantMember 2021-04-01 2021-06-30 0000949858 us-gaap:WarrantMember 2021-01-01 2021-06-30 0000949858 us-gaap:EmployeeStockOptionMember 2021-04-01 2021-06-30 0000949858 us-gaap:EmployeeStockOptionMember 2021-01-01 2021-06-30 0000949858 us-gaap:RestrictedStockUnitsRSUMember 2021-04-01 2021-06-30 0000949858 us-gaap:RestrictedStockUnitsRSUMember 2021-01-01 2021-06-30 0000949858 us-gaap:RestrictedStockUnitsRSUMember 2021-01-01 2021-06-30 0000949858 us-gaap:RestrictedStockUnitsRSUMember 2021-04-01 2021-06-30 0000949858 us-gaap:RestrictedStockUnitsRSUMember 2020-04-01 2020-06-30 0000949858 us-gaap:RestrictedStockUnitsRSUMember 2020-01-01 2020-06-30 0000949858 us-gaap:RestrictedStockUnitsRSUMember 2020-12-31 0000949858 achv:WarrantsIssuedInSeptemberTwoThousandSeventeenMember 2021-06-30 0000949858 achv:WarrantsIssuedInJuneTwoThousandEighteenMember 2021-06-30 0000949858 achv:WarrantsIssuedInOctoberTwoThousandEighteenMember 2021-06-30 0000949858 achv:WarrantsIssuedInMayTwoThousandNinteenMember 2021-06-30 0000949858 achv:WarrantsIssuedInDecemberTwoThousandNineteenMember 2021-06-30 0000949858 achv:WarrantsIssuedInAprilTwoThousandTwentyMember 2021-06-30 0000949858 achv:WarrantsIssuedInAprilTwoThousandTwenty1Member 2021-06-30 0000949858 achv:WarrantsIssuedInAprilTwoThousandTwenty2Member 2021-06-30 0000949858 achv:WarrantsIssuedInAugustTwoThousandTwentyMember 2021-06-30 0000949858 achv:WarrantsIssuedInDecemberTwoThousandTwentyMember 2021-06-30 0000949858 achv:WarrantsIssuedInSeptemberTwoThousandSeventeenMember 2021-01-01 2021-06-30 0000949858 achv:WarrantsIssuedInJuneTwoThousandEighteenMember 2021-01-01 2021-06-30 0000949858 achv:WarrantsIssuedInOctoberTwoThousandEighteenMember 2021-01-01 2021-06-30 0000949858 achv:WarrantsIssuedInMayTwoThousandNinteenMember 2021-01-01 2021-06-30 0000949858 achv:WarrantsIssuedInDecemberTwoThousandNineteenMember 2021-01-01 2021-06-30 0000949858 achv:WarrantsIssuedInAprilTwoThousandTwentyMember 2021-01-01 2021-06-30 0000949858 achv:WarrantsIssuedInAprilTwoThousandTwenty1Member 2021-01-01 2021-06-30 0000949858 achv:WarrantsIssuedInAprilTwoThousandTwenty2Member 2021-01-01 2021-06-30 0000949858 achv:WarrantsIssuedInDecemberTwoThousandTwentyMember 2021-01-01 2021-06-30 0000949858 achv:WarrantsIssuedInAprilTwoThousandTwentyFinancingMember 2021-06-30 0000949858 achv:WarrantsIssuedInAprilTwoThousandTwentyFinancingMember 2021-01-01 2021-06-30 0000949858 achv:WarrantsIssuedInDecemberTwoThousandNineteenMember 2020-06-30 0000949858 achv:WarrantsIssuedInDecemberTwoThousandNineteenMember 2020-01-01 2020-06-30 0000949858 achv:VancouverOfficeOperatingLeaseMember 2021-06-30 0000949858 stpr:CA-BC achv:VancouverOfficeOperatingLeaseMember 2018-11-18 2018-11-19 utr:sqft 0000949858 stpr:CA-BC achv:VancouverOfficeOperatingLeaseMember 2018-11-19 0000949858 stpr:CA-BC achv:VancouverOfficeOperatingLeaseMember 2021-01-01 2021-06-30 0000949858 achv:PikeMember achv:SeattleOfficeOperatingLeaseMember 2017-12-10 2017-12-11 0000949858 achv:PikeMember achv:SeattleOfficeOperatingLeaseMember 2021-01-01 2021-06-30 0000949858 achv:PikeMember achv:SeattleOfficeOperatingLeaseMember 2018-03-01 0000949858 achv:VancouverOfficeOperatingLeaseMember 2021-04-01 2021-06-30 0000949858 achv:SeattleOfficeOperatingLeaseMember 2021-04-01 2021-06-30 0000949858 achv:VancouverOfficeOperatingLeaseMember 2020-04-01 2020-06-30 0000949858 achv:SeattleOfficeOperatingLeaseMember 2020-04-01 2020-06-30 0000949858 achv:SeattleOfficeOperatingLeaseMember 2021-01-01 2021-06-30 0000949858 achv:VancouverOfficeOperatingLeaseMember 2020-01-01 2020-06-30 0000949858 achv:SeattleOfficeOperatingLeaseMember 2020-01-01 2020-06-30 0000949858 us-gaap:SubsequentEventMember achv:NationalInstituteOnDrugAbuseMember 2021-08-01 2021-08-01 0000949858 us-gaap:SubsequentEventMember achv:NationalInstituteOnDrugAbuseMember 2021-07-31 achv:Adult 0000949858 us-gaap:SubsequentEventMember achv:NationalInstituteOnDrugAbuseMember 2021-07-01 2021-07-31

 

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 033-80623

Achieve Life Sciences, Inc.

(Exact Name of Registrant as Specified in Its Charter)

 

Delaware

 

95-4343413

(State or Other Jurisdiction of

 

(I.R.S. Employer

Incorporation or Organization)

 

Identification Number)

1040 West Georgia Street, Suite 1030, Vancouver, British Columbia, Canada V6E 4H1

(Address of Principal Executive Offices)

(604) 210-2217

(Registrant’s telephone number, including area code)

 

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

 

Title of each class

Trading Symbol

Name of exchange on which registered

 

Common Stock, par value $0.001 per share

ACHV

The NASDAQ Capital 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  

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

As of August 12, 2021, there were 9,452,223 shares of the registrant’s Common Stock, $0.001 par value per share, outstanding.

 


 

Achieve Life Sciences, Inc.

Index to Form 10-Q

 

 

Page
Number

 

 

Part I.   Financial Information

3

 

 

 

Item 1

Consolidated Financial Statements (unaudited)

3

 

 

 

 

Consolidated Balance Sheets as of June 30, 2021 (unaudited) and December 31, 2020

3

 

 

 

 

Consolidated Statements of Loss and Comprehensive Loss (unaudited) for the three and six months ended June 30, 2021 and June 30, 2020

4

 

 

 

 

Consolidated Statements of Cash Flows (unaudited) for the six months ended June 30, 2021 and June 30, 2020

5

 

 

 

 

Consolidated Statements of Stockholders’ Equity (unaudited) for the six months ended June 30, 2021 and June 30, 2020

6

 

 

 

 

Notes to Consolidated Financial Statements (unaudited)

7

 

 

 

Item 2.

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

18

 

 

 

 

 

 

Item 4.

Controls and Procedures

27

 

 

Part II.   Other Information

28

 

 

 

Item 1A.

Risk Factors

29

 

 

 

Item 6.

Exhibits

53

 

 

Items 2, 3 and 4 are not applicable and therefore have been omitted.

 

 

 

Signatures

54

2


 

PART I. FINANCIAL INFORMATION

Item 1.

Consolidated Financial Statements

Achieve Life Sciences, Inc.

Consolidated Balance Sheets

(Unaudited)

(In thousands, except per share and share amounts) 

 

 

 

June 30,

 

 

December 31,

 

 

 

2021

 

 

2020

 

 

 

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents [note 5]

 

$

42,001

 

 

$

35,853

 

Prepaid expenses and other assets

 

 

430

 

 

 

1,122

 

Total current assets

 

 

42,431

 

 

 

36,975

 

Property and equipment, net

 

 

27

 

 

 

42

 

Right-of-use assets [note 7]

 

 

94

 

 

 

146

 

Other assets and restricted cash [note 5]

 

 

227

 

 

 

237

 

License agreement [note 3 and 4]

 

 

1,752

 

 

 

1,864

 

Goodwill [note 4]

 

 

1,034

 

 

 

1,034

 

Total assets

 

$

45,565

 

 

$

40,298

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

575

 

 

$

332

 

Accrued liabilities other

 

 

193

 

 

 

584

 

Accrued clinical liabilities

 

 

3,039

 

 

 

453

 

Accrued compensation

 

 

795

 

 

 

1,474

 

Current portion of long-term obligations [note 7]

 

 

68

 

 

 

92

 

Total current liabilities

 

 

4,670

 

 

 

2,935

 

Long-term obligations [note 7]

 

 

41

 

 

 

77

 

Total liabilities

 

 

4,711

 

 

 

3,012

 

Commitments and contingencies [note 7]

 

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

 

 

Series A convertible preferred stock, $0.001 par value, 9,158 shares designated, zero

issued and outstanding at June 30, 2021 and zero issued and outstanding at December 31, 2020.

 

 

 

 

 

 

Series B convertible preferred stock, $0.001 par value, 6,256 shares designated, zero

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

 

 

 

 

 

 

Common stock, $0.001 par value, 150,000,000 shares authorized, 9,452,223 issued and outstanding at June 30, 2021 and 6,111,735 issued and outstanding at December 31, 2020, respectively.

 

 

79

 

 

 

76

 

Additional paid-in capital

 

 

120,515

 

 

 

97,640

 

Accumulated deficit

 

 

(79,744

)

 

 

(60,434

)

Accumulated other comprehensive income

 

 

4

 

 

 

4

 

Total stockholders' equity

 

 

40,854

 

 

 

37,286

 

Total liabilities and stockholders' equity

 

$

45,565

 

 

$

40,298

 

Subsequent events [note 8]

 

 

 

 

 

 

 

 

 

See accompanying notes.

3


Achieve Life Sciences, Inc.

Consolidated Statements of Loss and Comprehensive Loss

(Unaudited)

(In thousands, except per share and share amounts)

 

 

 

Three Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

EXPENSES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

9,227

 

 

 

1,103

 

 

 

14,869

 

 

 

2,644

 

General and administrative

 

 

2,075

 

 

 

1,815

 

 

 

4,417

 

 

 

3,631

 

Total operating expenses

 

 

11,302

 

 

 

2,918

 

 

 

19,286

 

 

 

6,275

 

OTHER INCOME (EXPENSE)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

3

 

 

 

3

 

 

 

11

 

 

 

45

 

Other expenses

 

 

(12

)

 

 

(7

)

 

 

(35

)

 

 

(12

)

Total other income (expense)

 

 

(9

)

 

 

(4

)

 

 

(24

)

 

 

33

 

Net loss and comprehensive loss

 

$

(11,311

)

 

$

(2,922

)

 

 

(19,310

)

 

 

(6,242

)

Basic and diluted net loss per common share

 

$

(1.53

)

 

$

(1.68

)

 

$

(2.85

)

 

$

(3.79

)

Weighted average shares used in computation of basic and diluted net loss per common share

 

 

7,390,600

 

 

 

1,744,014

 

 

 

6,764,688

 

 

 

1,645,426

 

 

See accompanying notes.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4


 

Achieve Life Sciences, Inc.

Consolidated Statements of Cash Flows

(Unaudited)

(In thousands)

 

 

 

Six Months Ended

 

 

 

June 30,

 

 

 

2021

 

 

2020

 

Operating Activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(19,310

)

 

$

(6,242

)

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

 

 

 

 

 

 

 

 

Depreciation and amortization [note 3]

 

 

127

 

 

 

126

 

Stock-based compensation [note 6 [c] and note 6 [d]]

 

 

1,163

 

 

 

610

 

Shares issued as settlement with trade vendor

 

 

41

 

 

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Amounts receivable

 

 

 

 

 

8

 

Prepaid expenses and other assets

 

 

702

 

 

 

(142

)

Accounts payable

 

 

243

 

 

 

(336

)

Accrued liabilities other

 

 

(391

)

 

 

10

 

Accrued clinical liabilities

 

 

2,585

 

 

 

(314

)

Accrued compensation

 

 

(680

)

 

 

(381

)

Lease obligation [note 7]

 

 

(8

)

 

 

2

 

Net cash used in operating activities

 

 

(15,528

)

 

 

(6,659

)

Financing Activities:

 

 

 

 

 

 

 

 

Proceeds from the April 2020 private placement, net of issuance costs

 

 

 

 

 

1,579

 

Financing costs relating to December 2019 public offering

 

 

 

 

 

(34

)

Proceeds from exercise of warrants

 

 

331

 

 

 

589

 

Proceeds from the May 2021 public offering, net of issuance costs

 

 

21,343

 

 

 

 

Financing costs relating to purchase agreement with Lincoln Park Capital

 

 

 

 

 

(14

)

Net cash provided by financing activities

 

 

21,674

 

 

 

2,120

 

Investing Activities:

 

 

 

 

 

 

 

 

Purchase of property and equipment

 

 

 

 

 

(14

)

Net cash used in investing activities

 

 

 

 

 

(14

)

Effect of exchange rate changes on cash

 

 

2

 

 

 

 

Net increase (decrease) in cash, cash equivalents and restricted cash

 

 

6,148

 

 

 

(4,553

)

Cash, cash equivalents and restricted cash at beginning of the period

 

 

35,903

 

 

 

16,714

 

Cash, cash equivalents and restricted cash at end of the period

 

$

42,051

 

 

$

12,161

 

 

See accompanying notes.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5


 

 

 

Achieve Life Sciences, Inc.

 

Consolidated Statements of Stockholders’ Equity

(Unaudited)

(In thousands, except share amounts)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

Total,

 

 

 

Common Stock

 

 

Preferred Stock

 

 

Paid-in

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

Balance, December 31, 2020

 

 

6,111,735

 

 

$

76

 

 

 

 

 

$

 

 

$

97,640

 

 

$

4

 

 

$

(60,434

)

 

$

37,286

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

542

 

 

 

 

 

 

 

 

 

542

 

Shares issued on exercise of warrants

 

 

35,217

 

 

 

 

 

 

 

 

 

 

 

 

236

 

 

 

 

 

 

 

 

 

236

 

Shares issued as settlement with trade vendor

 

 

2,965

 

 

 

 

 

 

 

 

 

 

 

 

23

 

 

 

 

 

 

 

 

 

23

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(7,999

)

 

 

(7,999

)

Balance, March 31, 2021

 

 

6,149,917

 

 

$

76

 

 

 

 

 

$

 

 

$

98,441

 

 

$

4

 

 

$

(68,433

)

 

$

30,088

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

621

 

 

 

 

 

 

 

 

 

621

 

Shares issued on exercise of warrants

 

 

14,443

 

 

 

 

 

 

 

 

 

 

 

 

95

 

 

 

 

 

 

 

 

 

95

 

Shares issued - May 2021 public offering

 

 

3,285,714

 

 

 

3

 

 

 

 

 

 

 

 

 

21,340

 

 

 

 

 

 

 

 

 

21,343

 

Shares issued as settlement with trade vendor

 

 

2,149

 

 

 

 

 

 

 

 

 

 

 

 

18

 

 

 

 

 

 

 

 

 

18

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(11,311

)

 

 

(11,311

)

Balance, June 30, 2021

 

 

9,452,223

 

 

$

79

 

 

 

 

 

$

 

 

$

120,515

 

 

$

4

 

 

$

(79,744

)

 

$

40,854

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

 

Total,

 

 

 

Common Stock

 

 

Preferred Stock

 

 

Paid-in

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

Balance, December 31, 2019

 

 

1,474,258

 

 

$

41

 

 

 

1,121

 

 

$

 

 

$

63,709

 

 

$

4

 

 

$

(45,704

)

 

$

18,050

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

302

 

 

 

 

 

 

 

 

 

302

 

Costs relating to December 2019 financing

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(34

)

 

 

 

 

 

 

 

 

(34

)

Costs relating to purchase agreement with Lincoln Park Capital

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(13

)

 

 

 

 

 

 

 

 

(13

)

Shares issued on conversion of Series B preferred shares

 

 

93,379

 

 

 

2

 

 

 

(1,121

)

 

 

 

 

 

(2

)

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(3,320

)

 

 

(3,320

)

Balance, March 31, 2020

 

 

1,567,637

 

 

$

43

 

 

 

 

 

$

 

 

$

63,962

 

 

$

4

 

 

$

(49,024

)

 

$

14,985

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

308

 

 

 

 

 

 

 

 

 

308

 

Costs relating to purchase agreement with Lincoln Park Capital

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1

)

 

 

 

 

 

 

 

 

(1

)

Shares issued on exercise of warrants

 

 

89,281

 

 

 

 

 

 

 

 

 

 

 

 

589

 

 

 

 

 

 

 

 

 

589

 

Shares issued - April 2020 private placement

 

 

280,782

 

 

 

6

 

 

 

 

 

 

 

 

 

1,573

 

 

 

 

 

 

 

 

 

1,579

 

Shares issued on conversion of preferred shares

 

 

 

 

 

2

 

 

 

 

 

 

 

 

 

(2

)

 

 

 

 

 

 

 

 

 

Adjustment of fractional shares on reverse stock split

 

 

3

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(2,922

)

 

 

(2,922

)

Balance, June 30, 2020

 

 

1,937,703

 

 

$

51

 

 

 

 

 

$

 

 

$

66,429

 

 

$

4

 

 

$

(51,946

)

 

$

14,538

 

 

See accompanying notes.

 

6


 

Achieve Life Sciences, Inc.

Notes to Consolidated Financial Statements

(Unaudited)

 

 

1. NATURE OF BUSINESS, BASIS OF PRESENTATION AND LIQUIDITY RISK

Achieve Life Sciences, Inc. (referred to as “Achieve,” “we,” “us,” or “our”) is a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation. We were incorporated in the state of Delaware, and operate out of Vancouver, British Columbia and Seattle, Washington.

The unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP, for interim financial information and with the instructions to Form 10-Q.  Accordingly, they do not include all of the information and footnotes required to be presented for complete financial statements. The accompanying unaudited consolidated financial statements reflect all adjustments (consisting only of normal recurring items) which are, in the opinion of management, necessary for a fair presentation of the results for the interim periods presented. The accompanying consolidated Balance Sheet at December 31, 2020 has been derived from the audited consolidated financial statements included in our Annual Report on Form 10-K for the year then ended. The unaudited consolidated financial statements and related disclosures have been prepared with the assumption that users of the interim financial information have read or have access to the audited consolidated financial statements for the preceding fiscal year. Accordingly, these financial statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto included in the Annual Report on Form 10-K for the year ended December 31, 2020 and filed with the U.S. Securities and Exchange Commission, or the SEC, on March 11, 2021.

The consolidated financial statements include the accounts of Achieve and our wholly owned subsidiaries, Achieve Life Sciences Technologies Inc., Achieve Life Science, Inc., Extab Corporation, and Achieve Pharma UK Limited. All intercompany balances and transactions have been eliminated.

Liquidity

We have historically experienced recurring losses from operations and have incurred an accumulated deficit of $79.7 million through June 30, 2021. At June 30, 2021, we had cash and cash equivalents of $42.0 million and a positive working capital balance of $37.8 million. For the six months ended June 30, 2021, we incurred a net loss of $19.3 million and net cash used in operating activities was $15.5 million. We have historically financed our operations through equity financings. While we believe that we will be able to settle our commitments and liabilities in the normal course of business as they fall due during the next 12 months, as a development-stage company with no current sources of revenue, we are dependent on our ability to raise funds (through public or private securities offerings, debt financings, government funding or grants, or other sources, which may include licensing, collaborations or other strategic transactions or arrangements) to support the ongoing advancement of our clinical trials and corporate activities.

 

 

2. ACCOUNTING POLICIES

The preparation of financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect reported amounts and related disclosures. We have discussed those estimates that we believe are critical and require the use of complex judgment in their application in our audited financial statements for the year ended December 31, 2020 in our Annual Report on Form 10-K filed with the SEC, on March 11, 2021. Since December 31, 2020, there have been no material changes to our critical accounting policies or the methodologies or assumptions we apply under them. 

 

 

3. INTANGIBLES

All of our intangible assets are subject to amortization and are amortized using the straight-line method over their estimated useful life.

We acquired license and supply agreements in relation to cytisinicline upon the acquisition of Extab Corporation, or Extab, on May 18, 2015. The agreements were determined to have a fair value of $3.1 million with an estimated useful life of 14 years.

The components of intangible assets were as follows:

 

 

 

June 30, 2021

 

 

December 31, 2020

 

 

 

Gross Carrying

 

 

Accumulated