10-Q
0001808158 Unlimited00-0000000Q3UnlimitedfalseUnlimited A8Unlimited --12-310001808158rptx:TwoThousandTwentyEmployeeSharePurchasePlanMember2021-07-012021-09-300001808158rptx:CollaborationAndLicenseAgreementMemberrptx:BristolMyersSquibbCompanyMember2022-09-300001808158rptx:TwoThousandTwentyEmployeeSharePurchasePlanMember2022-09-300001808158rptx:CombinedLicensesMemberrptx:HoffmannLaRocheIncAndFHoffmannLaRocheLtdMember2022-09-300001808158us-gaap:FairValueInputsLevel1Memberus-gaap:USTreasuryNotesSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2022-09-300001808158rptx:BristolMyersSquibbCompanyMemberrptx:CollaborationAndLicenseAgreementMember2022-01-012022-09-300001808158us-gaap:USTreasurySecuritiesMember2022-09-300001808158us-gaap:ResearchAndDevelopmentExpenseMember2021-07-012021-09-300001808158us-gaap:AdditionalPaidInCapitalMember2022-09-300001808158rptx:MoneyMarketFundsIncludedInCashAndCashEquivalentsMember2022-09-300001808158rptx:TwoThousandTwentyEmployeeSharePurchasePlanMember2022-07-012022-09-3000018081582021-03-310001808158us-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2022-09-300001808158us-gaap:CommonStockMember2020-12-310001808158us-gaap:CommonStockMember2021-04-012021-06-300001808158rptx:TwoThousandTwentyEmployeeSharePurchasePlanMember2022-01-012022-09-300001808158us-gaap:AdditionalPaidInCapitalMember2021-03-310001808158us-gaap:USTreasurySecuritiesMember2021-12-310001808158us-gaap:AdditionalPaidInCapitalMember2022-07-012022-09-300001808158us-gaap:USTreasuryNotesSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2022-09-300001808158rptx:ResearchActivitiesMemberrptx:BristolMyersSquibbCompanyMember2022-09-300001808158srt:MaximumMemberrptx:TwoThousandTwentyEquityIncentivePlanMember2020-06-300001808158us-gaap:CommonStockMember2021-06-300001808158us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-09-300001808158us-gaap:AdditionalPaidInCapitalMember2022-04-012022-06-3000018081582022-03-310001808158us-gaap:RetainedEarningsMember2022-06-300001808158us-gaap:AccumulatedOtherComprehensiveIncomeMember2022-07-012022-09-300001808158us-gaap:CommonStockMember2022-09-300001808158rptx:BristolMyersSquibbCompanyMember2022-09-300001808158us-gaap:AdditionalPaidInCapitalMember2021-12-310001808158us-gaap:RetainedEarningsMember2022-01-012022-03-310001808158us-gaap:EmployeeStockOptionMember2021-07-012021-09-300001808158rptx:OptionsToPurchaseCommonSharesMember2021-01-012021-09-300001808158us-gaap:RetainedEarningsMember2021-03-310001808158us-gaap:CommonStockMemberrptx:TwoThousandTwentyEmployeeSharePurchasePlanMember2021-07-012021-09-300001808158us-gaap:USTreasuryBillSecuritiesMemberus-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2022-09-3000018081582021-01-012021-03-310001808158rptx:TwoThousandTwentyEmployeeSharePurchasePlanMember2020-06-012020-06-300001808158rptx:CompletionOfContinuingTrialsMemberrptx:HoffmannLaRocheIncAndFHoffmannLaRocheLtdMember2022-09-300001808158rptx:CollaborationAndLicenseAgreementMemberrptx:HoffmannLaRocheIncAndFHoffmannLaRocheLtdMember2022-01-012022-09-300001808158rptx:ResearchAndDevelopmentServicesMemberrptx:CollaborationAndLicenseAgreementMemberrptx:HoffmannLaRocheIncAndFHoffmannLaRocheLtdMember2022-07-012022-09-300001808158rptx:TwoThousandTwentyEmployeeSharePurchasePlanMember2021-01-012021-09-3000018081582022-07-012022-09-300001808158rptx:EstimatedSharesIssuableUnderTheEsppMember2022-01-012022-09-300001808158rptx:CollaborationAndLicenseAgreementMemberrptx:BristolMyersSquibbCompanyMember2020-05-012020-05-300001808158rptx:TwoThousandTwentyEmployeeSharePurchasePlanMember2022-01-012022-03-310001808158rptx:TwoThousandTwentyEquityIncentivePlanMember2022-09-300001808158rptx:OptionsToPurchaseCommonSharesMember2022-01-012022-09-300001808158rptx:RepareTherapeuticsIncorporationOptionPlanMember2020-06-300001808158us-gaap:RetainedEarningsMember2021-06-300001808158rptx:TwoThousandTwentyEmployeeSharePurchasePlanMember2021-07-012021-09-3000018081582022-06-300001808158us-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001808158srt:MaximumMemberrptx:ResearchDevelopmentAndRegulatoryMilestonesMemberrptx:CollaborationAndLicenseAgreementMemberrptx:BristolMyersSquibbCompanyMember2020-05-310001808158us-gaap:CommonStockMemberrptx:RepareTherapeuticsIncorporationOptionPlanMember2020-06-3000018081582021-12-310001808158rptx:CollaborationAndLicenseAgreementMemberrptx:BristolMyersSquibbCompanyMember2021-01-012021-09-300001808158us-gaap:FairValueInputsLevel1Memberus-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2022-09-300001808158us-gaap:EmployeeStockOptionMember2021-01-012021-09-300001808158us-gaap:AdditionalPaidInCapitalMember2022-06-300001808158us-gaap:USTreasuryBillSecuritiesMember2022-09-300001808158us-gaap:CommonStockMember2022-03-310001808158rptx:ClinicalTrialMaterialsMemberrptx:CollaborationAndLicenseAgreementMemberrptx:HoffmannLaRocheIncAndFHoffmannLaRocheLtdMember2022-09-300001808158rptx:OptionsToPurchaseCommonSharesMember2022-07-012022-09-300001808158rptx:CollaborationAndLicenseAgreementMemberrptx:BristolMyersSquibbCompanyMember2022-07-012022-09-300001808158rptx:HoffmannLaRocheIncAndFHoffmannLaRocheLtdMemberrptx:CollaborationAndLicenseAgreementMember2021-12-310001808158us-gaap:RetainedEarningsMember2021-12-310001808158rptx:EstimatedSharesIssuableUnderTheEsppMember2021-07-012021-09-300001808158srt:MaximumMemberrptx:TwoThousandTwentyEquityIncentivePlanMember2020-06-012020-06-300001808158us-gaap:CommonStockMemberrptx:TwoThousandTwentyEmployeeSharePurchasePlanMember2022-01-012022-03-310001808158us-gaap:CommonStockMember2021-12-310001808158rptx:OptionsToPurchaseCommonSharesMember2021-07-012021-09-300001808158rptx:CombinedLicensesMemberrptx:HoffmannLaRocheIncAndFHoffmannLaRocheLtdMemberrptx:CollaborationAndLicenseAgreementMember2022-07-012022-09-300001808158us-gaap:ResearchAndDevelopmentExpenseMember2022-01-012022-09-300001808158rptx:CollaborationAndLicenseAgreementMemberrptx:HoffmannLaRocheIncAndFHoffmannLaRocheLtdMember2022-10-012022-10-310001808158rptx:AdditionalClinicalDevelopmentPlanMemberrptx:CollaborationAndLicenseAgreementMemberrptx:HoffmannLaRocheIncAndFHoffmannLaRocheLtdMember2022-09-300001808158rptx:BristolMyersSquibbCompanyMemberrptx:CollaborationAndLicenseAgreementMember2021-10-012021-12-310001808158us-gaap:FairValueInputsLevel2Memberus-gaap:USTreasuryBillSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2022-09-300001808158us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001808158us-gaap:FairValueMeasurementsRecurringMember2021-12-310001808158us-gaap:RetainedEarningsMember2021-09-300001808158us-gaap:AdditionalPaidInCapitalMemberrptx:TwoThousandTwentyEmployeeSharePurchasePlanMember2022-07-012022-09-300001808158rptx:ClinicalTrialMaterialsMemberrptx:HoffmannLaRocheIncAndFHoffmannLaRocheLtdMemberrptx:CollaborationAndLicenseAgreementMember2022-01-012022-09-300001808158us-gaap:AdditionalPaidInCapitalMember2021-06-300001808158us-gaap:CommonStockMember2022-06-3000018081582021-01-012021-09-300001808158us-gaap:AdditionalPaidInCapitalMember2021-01-012021-03-310001808158us-gaap:FairValueInputsLevel1Memberus-gaap:FairValueMeasurementsRecurringMember2022-09-300001808158us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001808158rptx:TwoThousandTwentyEmployeeSharePurchasePlanMember2022-07-012022-09-300001808158rptx:ClinicalTrialMaterialsMemberrptx:CollaborationAndLicenseAgreementMemberrptx:HoffmannLaRocheIncAndFHoffmannLaRocheLtdMember2022-07-012022-09-300001808158rptx:CombinedLicensesMemberrptx:HoffmannLaRocheIncAndFHoffmannLaRocheLtdMemberrptx:CollaborationAndLicenseAgreementMember2022-01-012022-09-300001808158rptx:BristolMyersSquibbCompanyMemberrptx:CollaborationAndLicenseAgreementMember2021-07-012021-09-300001808158rptx:EstimatedSharesIssuableUnderTheEsppMember2022-07-012022-09-300001808158us-gaap:FairValueInputsLevel2Memberus-gaap:USTreasuryNotesSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2022-09-300001808158rptx:TwoThousandTwentyEmployeeSharePurchasePlanMember2022-01-012022-09-300001808158us-gaap:FairValueInputsLevel2Memberus-gaap:FairValueMeasurementsRecurringMember2022-09-300001808158rptx:CollaborationAndLicenseAgreementMemberrptx:HoffmannLaRocheIncAndFHoffmannLaRocheLtdMember2022-07-012022-09-300001808158us-gaap:RetainedEarningsMember2020-12-310001808158us-gaap:RetainedEarningsMember2022-07-012022-09-3000018081582022-10-310001808158us-gaap:AdditionalPaidInCapitalMemberrptx:TwoThousandTwentyEmployeeSharePurchasePlanMember2022-01-012022-03-310001808158us-gaap:AdditionalPaidInCapitalMember2022-01-012022-03-310001808158rptx:EstimatedSharesIssuableUnderTheEsppMember2021-01-012021-09-300001808158us-gaap:AdditionalPaidInCapitalMember2021-09-300001808158srt:MaximumMemberrptx:CommercialMilestonesMemberrptx:BristolMyersSquibbCompanyMemberrptx:CollaborationAndLicenseAgreementMember2020-05-310001808158us-gaap:RetainedEarningsMember2021-07-012021-09-3000018081582021-07-012021-09-3000018081582021-06-300001808158rptx:CollaborationAndLicenseAgreementMemberrptx:BristolMyersSquibbCompanyMember2021-12-310001808158us-gaap:AdditionalPaidInCapitalMember2021-07-012021-09-300001808158us-gaap:RetainedEarningsMember2021-04-012021-06-300001808158rptx:TwoThousandTwentyEmployeeSharePurchasePlanMember2020-06-300001808158us-gaap:CommonStockMember2021-01-012021-03-310001808158srt:MaximumMemberrptx:BristolMyersSquibbCompanyMemberrptx:CollaborationAndLicenseAgreementMember2020-05-310001808158us-gaap:RetainedEarningsMember2022-03-310001808158us-gaap:FairValueInputsLevel1Memberus-gaap:USTreasuryNotesSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2021-12-3100018081582022-01-012022-09-300001808158us-gaap:RetainedEarningsMember2021-01-012021-03-310001808158us-gaap:GeneralAndAdministrativeExpenseMember2021-07-012021-09-300001808158rptx:MoneyMarketFundsIncludedInCashAndCashEquivalentsMember2021-12-310001808158us-gaap:FairValueMeasurementsRecurringMember2022-09-300001808158us-gaap:CommonStockMember2022-01-012022-03-310001808158us-gaap:CommonStockMember2021-07-012021-09-300001808158us-gaap:GeneralAndAdministrativeExpenseMember2021-01-012021-09-300001808158us-gaap:USTreasuryBillSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2022-09-300001808158us-gaap:AdditionalPaidInCapitalMember2020-12-310001808158us-gaap:CommonStockMember2021-03-310001808158us-gaap:CommonStockMember2021-09-3000018081582021-04-012021-06-300001808158us-gaap:RetainedEarningsMember2022-04-012022-06-300001808158us-gaap:AdditionalPaidInCapitalMember2021-04-012021-06-3000018081582020-12-3100018081582022-01-012022-03-310001808158us-gaap:FairValueInputsLevel2Memberus-gaap:USTreasuryNotesSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2021-12-3100018081582021-09-300001808158us-gaap:GeneralAndAdministrativeExpenseMember2022-07-012022-09-3000018081582021-01-012021-12-310001808158us-gaap:ResearchAndDevelopmentExpenseMember2022-07-012022-09-300001808158rptx:OptionToLicenseDruggableTargetLesionsMemberrptx:BristolMyersSquibbCompanyMember2022-09-300001808158us-gaap:AdditionalPaidInCapitalMemberrptx:TwoThousandTwentyEmployeeSharePurchasePlanMember2021-07-012021-09-300001808158us-gaap:FairValueInputsLevel1Memberus-gaap:MoneyMarketFundsMemberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001808158us-gaap:RetainedEarningsMember2022-09-300001808158us-gaap:CommonStockMemberrptx:TwoThousandTwentyEmployeeSharePurchasePlanMember2022-07-012022-09-300001808158rptx:TransferOfClinicalTrialMaterialsMemberrptx:HoffmannLaRocheIncAndFHoffmannLaRocheLtdMember2022-09-300001808158us-gaap:EmployeeStockOptionMember2022-07-012022-09-300001808158rptx:ResearchAndDevelopmentServicesMemberrptx:CollaborationAndLicenseAgreementMemberrptx:HoffmannLaRocheIncAndFHoffmannLaRocheLtdMember2022-01-012022-09-300001808158rptx:BristolMyersSquibbCompanyMember2022-01-012022-09-3000018081582022-09-300001808158rptx:HoffmannLaRocheIncAndFHoffmannLaRocheLtdMember2022-09-300001808158rptx:CollaborationAndLicenseAgreementMemberrptx:BristolMyersSquibbCompanyMember2020-06-012020-06-300001808158us-gaap:GeneralAndAdministrativeExpenseMember2022-01-012022-09-300001808158rptx:OptionsToLicenseUndruggableTargetMemberrptx:BristolMyersSquibbCompanyMember2022-09-3000018081582022-04-012022-06-300001808158us-gaap:CommonStockMember2022-07-012022-09-300001808158rptx:CommercialMilestonesMemberrptx:CollaborationAndLicenseAgreementMemberrptx:HoffmannLaRocheIncAndFHoffmannLaRocheLtdMember2022-01-012022-09-300001808158rptx:HoffmannLaRocheIncAndFHoffmannLaRocheLtdMemberrptx:CollaborationAndLicenseAgreementMember2022-07-012022-07-310001808158srt:MaximumMemberrptx:TwoThousandTwentyEmployeeSharePurchasePlanMember2020-06-300001808158us-gaap:USTreasuryNotesSecuritiesMemberus-gaap:FairValueMeasurementsRecurringMember2021-12-310001808158rptx:HoffmannLaRocheIncAndFHoffmannLaRocheLtdMemberrptx:CollaborationAndLicenseAgreementMember2022-09-300001808158us-gaap:ResearchAndDevelopmentExpenseMember2021-01-012021-09-300001808158us-gaap:EmployeeStockOptionMember2022-01-012022-09-300001808158us-gaap:AdditionalPaidInCapitalMember2022-03-310001808158us-gaap:CommonStockMember2022-04-012022-06-300001808158rptx:BristolMyersSquibbCompanyMemberrptx:CollaborationAndLicenseAgreementMember2020-05-310001808158rptx:HoffmannLaRocheIncAndFHoffmannLaRocheLtdMember2022-01-012022-09-30xbrli:pureiso4217:USDxbrli:sharesxbrli:sharesiso4217:USDrptx:Lease

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

(Mark One)

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

For the quarterly period ended September 30, 2022

OR

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

For the transition period from _________________ to ___________________

Commission File Number: 001-39335

 

Repare Therapeutics Inc.

(Exact Name of Registrant as Specified in its Charter)

 

 

Québec

Not applicable

(State or other jurisdiction of

incorporation or organization)

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

7210 Frederick-Banting, Suite 100

St-Laurent, Québec, Canada

H4S 2A1

(Address of principal executive offices)

(Zip Code)

 

Registrant’s telephone number, including area code: (857) 412-7018

 

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 shares, no par value

 

RPTX

 

The Nasdaq Stock Market LLC

 

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, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

 

 

Accelerated filer

 

 

 

 

 

Non-accelerated filer

 

 

Smaller reporting company

 

 

 

 

 

 

 

 

 

 

 

 

Emerging growth company

 

 

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

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

As of October 31, 2022, there were 41,961,510 of the registrant’s common shares, no par value per share, outstanding.

 

 


 

Table of Contents

 

 

 

Page

SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS

1

SUMMARY RISK FACTORS

2

PART I.

FINANCIAL INFORMATION

3

Item 1.

Financial Statements (Unaudited)

3

 

Condensed Consolidated Balance Sheets

3

 

Condensed Consolidated Statements of Operations and Comprehensive Loss

4

 

Condensed Consolidated Statements of Shareholders’ Equity

5

 

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

18

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

31

Item 4.

Controls and Procedures

31

PART II.

OTHER INFORMATION

33

Item 1.

Legal Proceedings

33

Item 1A.

Risk Factors

33

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

82

Item 3.

Defaults Upon Senior Securities

82

Item 4.

Mine Safety Disclosures

82

Item 5.

Other Information

82

Item 6.

Exhibits

83

Signatures

 

 

i


 

SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future financial condition, future operations, research and development costs, plans and objectives of management, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “positioned,” “potential,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report on Form 10-Q, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain.

The forward-looking statements in this Quarterly Report on Form 10-Q include, among other things, statements about:

the initiation, timing, progress and results of our current and future preclinical studies and clinical trials and related preparatory work and the period during which the results of the trials will become available, as well as our research and development programs;
our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
our ability to obtain regulatory approval of RP-6306 and any of our other current and future product candidates that we develop;
our ability to identify and develop additional product candidates using our SNIPRx platform;
business disruptions affecting the initiation, patient enrollment, development and operation of our clinical trials, including a public health emergency or pandemic, such as the coronavirus disease, or COVID-19 pandemic;
the evolving impact of the COVID-19 pandemic and any variants on our operations, the continuity of our business, including our preclinical studies and clinical trials, supply chains, general economic conditions and our ability to raise additional capital;
our ability to enroll patients in clinical trials, to timely and successfully complete those trials and to receive necessary regulatory approvals;
the timing of completion of enrollment and availability of data from our current preclinical studies and clinical trials, including our Phase 1 clinical trials of RP-6306;
the expected timing of filings with regulatory authorities for any product candidates that we develop, including RP-2119;
our expectations regarding the potential market size and the rate and degree of market acceptance for any product candidates that we develop;
the effects of competition with respect to RP-6306, camonsertib, RP-2119 or any of our other current or future product candidates, as well as innovations by current and future competitors in our industry;
our ability to fund our working capital requirements;
our intellectual property position, including the scope of protection we are able to establish, maintain and enforce for intellectual property rights covering our product candidates;
our financial performance and our ability to effectively manage our anticipated growth;
our ability to obtain additional funding for our operations; and
other risks and uncertainties, including those listed under the section titled “Risk Factors” in this Quarterly Report.

 

Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth, and involve known and unknown risks, uncertainties and other factors including, without limitation, risks, uncertainties and assumptions regarding the impact of the COVID-19 pandemic on our business, operations, strategy, goals and anticipated timelines, our ongoing and planned preclinical activities, our ability to initiate, enroll, conduct or complete ongoing and planned clinical trials, our timelines for regulatory submissions and our financial position that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You are urged to carefully review the disclosures we make concerning these risks and other factors that may affect our business and operating results in this Quarterly Report on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this document. Except as required by law, we do not intend, and undertake no obligation, to update any forward-looking information to reflect events or circumstances.

1


 

SUMMARY RISK FACTORS

Investing in our common shares involves numerous risks, including the risks described in “Part II—Item 1A. Risk Factors” of this Quarterly Report on Form 10-Q. Below are some of our principal risks, any one of which could materially adversely affect our business, financial condition, results of operations, and prospects:

Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
We will require substantial additional funding to finance our operations. If we are unable to raise capital when needed, we could be forced to delay, reduce, or terminate certain of our product development programs or other operations.
We are very early in our development efforts. If we are unable to advance our product candidates into and through clinical development, obtain regulatory approval and ultimately commercialize any of our product candidates, or experience significant delays in doing so, our business will be materially harmed.
Our business substantially depends upon the successful development of product candidates generated through the application of our SNIPRx platform, and in particular, our initial product candidates, camonsertib and RP-6306. If we, or our collaborators, are unable to obtain regulatory approval for, and successfully commercialize, products developed through the application of our SNIPRx platform, our business may be materially harmed.
The effects of health epidemics, including the ongoing COVID-19 pandemic, in regions where we, or the third parties on which we rely, have business operations could adversely impact our business, including our preclinical studies and clinical trials. The COVID-19 pandemic could materially affect our operations, including at our offices in Montréal and in the Boston Metro Area, and at our clinical trial sites, as well as the business or operations of our CROs or other third parties with whom we conduct business.
The successful development of targeted therapeutics, including our portfolio of synthetic lethality small molecule inhibitors, as well as any related diagnostics, is highly uncertain.
The regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, on a timely basis or at all, our business will be substantially harmed.
Synthetic lethality represents an emerging class of precision medicine targets, and negative perceptions of the efficacy, safety, or tolerability of this class of targets, including any that we develop, could adversely affect our ability to conduct our business, advance our product candidates or obtain regulatory approvals.
We may not be successful in applying our SNIPRx platform to discover synthetic lethality targets with therapeutic and commercial potential or in the discovery and development of commercially viable product candidates for us or our collaborators.
Difficulty in enrolling patients could delay or prevent clinical trials of our product candidates. We may find it difficult to enroll patients in our ongoing and planned clinical trials with the genomic alterations that these trials are designed to target.
We face substantial competition, which may result in others developing or commercializing drugs before or more successfully than us.
Our current and future collaborations will be important to our business. If we are unable to enter into new collaborations, or if these collaborations are not successful, our business could be adversely affected.
We rely on third parties to supply and manufacture our product candidates, and we expect to continue to rely on third parties to manufacture our products, if approved. The development of such product candidates and the commercialization of any products, if approved, could be stopped, delayed, or made less profitable if any such third party fails to provide us with sufficient quantities of product candidates or products, or fails to do so at acceptable quality levels or prices, or fails to maintain or achieve satisfactory regulatory compliance.
Our success depends in part on our ability to obtain intellectual property rights for our proprietary technologies and product candidates, as well as our ability to protect our intellectual property. It is difficult and costly to protect our proprietary rights and technology, and we may not be able to ensure their protection.
Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
The trading price of our common shares has been and is likely to continue to be volatile and fluctuate substantially.

2


 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

Repare Therapeutics Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

(Amounts in thousands of U.S. dollars, except share data)

 

 

 

As of
September 30,

 

 

As of
December 31,

 

 

 

2022

 

 

2021

 

ASSETS

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

 

Cash and cash equivalents

 

$

155,191

 

 

$

334,427

 

Marketable securities

 

 

215,162

 

 

 

7,439

 

Research and development tax credits receivable

 

 

2,907

 

 

 

2,580

 

Income tax receivable

 

 

629

 

 

 

 

Collaboration revenue receivable

 

 

9,626

 

 

 

 

Other receivables

 

 

1,447

 

 

 

654

 

Prepaid expenses

 

 

5,635

 

 

 

6,314

 

Total current assets

 

 

390,597

 

 

 

351,414

 

Property and equipment, net

 

 

4,683

 

 

 

5,604

 

Operating lease right-of-use assets

 

 

5,904

 

 

 

7,491

 

Other assets

 

 

497

 

 

 

586

 

Deferred tax assets

 

 

7,477

 

 

 

3,620

 

TOTAL ASSETS

 

$

409,158

 

 

$

368,715

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

 

Accounts payable

 

$

9,345

 

 

$

2,302

 

Accrued expenses and other current liabilities

 

 

15,615

 

 

 

18,622

 

Operating lease liability, current portion

 

 

2,127

 

 

 

1,721

 

Deferred revenue, current portion

 

 

34,784

 

 

 

11,921

 

Income tax payable

 

 

 

 

 

523

 

Total current liabilities

 

 

61,871

 

 

 

35,089

 

Operating lease liability, net of current portion

 

 

3,767

 

 

 

5,592

 

Deferred revenue, net of current portion

 

 

37,744

 

 

 

39,613

 

TOTAL LIABILITIES

 

 

103,382

 

 

 

80,294

 

SHAREHOLDERS’ EQUITY

 

 

 

 

 

 

Preferred shares, no par value per share; unlimited shares authorized
   as of September 30, 2022 and December 31, 2021, respectively;
0 shares issued
   and outstanding as of September 30, 2022, and December 31, 2021, respectively

 

 

 

 

 

 

Common shares, no par value per share; unlimited shares authorized as of
   September 30, 2022 and December 31, 2021;
41,961,510 and 41,850,162 shares
   issued and outstanding as of September 30, 2022 and December 31, 2021, respectively

 

 

481,782

 

 

 

480,699

 

Additional paid-in capital

 

 

32,173

 

 

 

17,988

 

Accumulated other comprehensive loss

 

 

(524

)

 

 

 

Accumulated deficit

 

 

(207,655

)

 

 

(210,266

)

Total shareholders’ equity

 

 

305,776

 

 

 

288,421

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

 

$

409,158

 

 

$

368,715

 

 

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

3


 

Repare Therapeutics Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

(Amounts in thousands of U.S. dollars, except share and per share data)

 

 

 

Three Months Ended
September 30,

 

 

Nine Months Ended
September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

Collaboration agreements

 

$

112,545

 

 

$

278

 

 

$

113,632

 

 

$

723

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development, net of tax credits

 

 

31,242

 

 

 

25,361

 

 

 

89,175

 

 

 

62,075

 

General and administrative

 

 

7,904

 

 

 

6,596

 

 

 

24,621

 

 

 

18,574

 

Total operating expenses

 

 

39,146

 

 

 

31,957

 

 

 

113,796

 

 

 

80,649

 

Income (loss) from operations

 

 

73,399

 

 

 

(31,679

)

 

 

(164

)

 

 

(79,926

)

Other income (expense), net

 

 

 

 

 

 

 

 

 

 

 

 

Realized and unrealized gain (loss) on foreign exchange

 

 

126

 

 

 

33

 

 

 

250

 

 

 

(92

)

Interest income

 

 

2,027

 

 

 

53

 

 

 

2,700

 

 

 

155

 

Other expense

 

 

(37

)

 

 

(7

)

 

 

(56

)

 

 

(21

)

Total other income, net

 

 

2,116

 

 

 

79

 

 

 

2,894

 

 

 

42

 

Income (loss) before income taxes

 

 

75,515

 

 

 

(31,600

)

 

 

2,730

 

 

 

(79,884

)

Income tax recovery (expense)

 

 

(54

)

 

 

708

 

 

 

(119

)

 

 

1,266

 

Net income (loss)

 

$

75,461

 

 

$

(30,892

)

 

$

2,611

 

 

$

(78,618

)

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized loss on available-for-sale marketable securities

 

$

(524

)

 

$

 

 

$

(524

)

 

$

 

Total other comprehensive loss

 

 

(524

)

 

 

 

 

 

(524

)

 

 

 

Comprehensive income (loss)

 

$

74,937

 

 

$

(30,892

)

 

$

2,087

 

 

$

(78,618

)

Net income (loss) per share attributable to common
   shareholders:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

1.80

 

 

$

(0.83

)

 

$

0.06

 

 

$

(2.12

)

Diluted

 

$

1.71

 

 

$

(0.83

)

 

$

0.06

 

 

$

(2.12

)

Weighted-average common shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

41,945,617

 

 

 

37,122,668

 

 

 

41,902,554

 

 

 

37,026,116

 

Diluted

 

 

44,177,376

 

 

 

37,122,668

 

 

 

44,160,481

 

 

 

37,026,116

 

 

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

4


 

Repare Therapeutics Inc.

Condensed Consolidated Statements of Shareholders’ Equity

(Unaudited)

(Amounts in thousands of U.S. dollars, except share data)

 

 

 

Common Shares

 

 

Additional
Paid-in
Capital

 

 

Accumulated
Other Comprehensive Loss

 

 

Accumulated
Deficit

 

 

Total
Shareholders’
Equity

 

 

 

Shares

 

 

Amount

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2020

 

 

36,902,924

 

 

$

384,313

 

 

$

5,875

 

 

$

 

 

$

(103,358

)

 

$

286,830

 

Exercise of stock options

 

 

87,786

 

 

 

297

 

 

 

(114

)

 

 

 

 

 

 

 

 

183

 

Share-based compensation expense

 

 

 

 

 

 

 

 

2,057

 

 

 

 

 

 

 

 

 

2,057

 

Net loss and comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(21,417

)

 

 

(21,417

)

Balance, March 31, 2021

 

 

36,990,710

 

 

$

384,610

 

 

$

7,818

 

 

$

 

 

$

(124,775

)

 

$

267,653

 

Exercise of stock options

 

 

115,497

 

 

 

731

 

 

 

(282

)

 

 

 

 

 

 

 

 

449

 

Share-based compensation expense

 

 

 

 

 

 

 

 

3,183

 

 

 

 

 

 

 

 

 

3,183

 

Issuance of common shares

 

 

3,299

 

 

 

113

 

 

 

 

 

 

 

 

 

 

 

 

113

 

Net loss and comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(26,309

)

 

 

(26,309

)

Balance, June 30, 2021

 

 

37,109,506

 

 

$

385,454

 

 

$

10,719

 

 

$

 

 

$

(151,084

)

 

$

245,089

 

Exercise of stock options

 

 

14,489

 

 

 

129

 

 

 

(49

)

 

 

 

 

 

 

 

 

80

 

Share-based compensation expense

 

 

 

 

 

 

 

 

3,693

 

 

 

 

 

 

 

 

 

3,693

 

Issuance of common shares under the
   2020 Employee Share Purchase Plan

 

 

9,943

 

 

 

407

 

 

 

(124

)

 

 

 

 

 

 

 

 

283

 

Net loss and comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(30,892

)

 

 

(30,892

)

Balance, September 30, 2021

 

 

37,133,938

 

 

$

385,990

 

 

$

14,239

 

 

$

 

 

$

(181,976

)

 

$

218,253

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2021

 

 

41,850,162

 

 

$

480,699

 

 

$

17,988

 

 

$

 

 

$

(210,266

)

 

$

288,421

 

Exercise of stock options

 

 

12,235

 

 

 

46

 

 

 

(18

)

 

 

 

 

 

 

 

 

28

 

Share-based compensation expense

 

 

 

 

 

 

 

 

4,755

 

 

 

 

 

 

 

 

 

4,755

 

Issuance of common shares under the
   2020 Employee Share Purchase Plan

 

 

16,807

 

 

 

303

 

 

 

(90

)

 

 

 

 

 

 

 

 

213

 

Net loss and comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(34,757

)

 

 

(34,757

)

Balance, March 31, 2022

 

 

41,879,204

 

 

$

481,048

 

 

$

22,635

 

 

$

 

 

$

(245,023

)

 

$

258,660

 

Exercise of stock options

 

 

44,268

 

 

 

332

 

 

 

(127

)

 

 

 

 

 

 

 

 

205

 

Share-based compensation expense

 

 

 

 

 

 

 

 

4,745

 

 

 

 

 

 

 

 

 

4,745

 

Net loss and comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(38,093

)

 

 

(38,093

)

Balance, June 30, 2022

 

 

41,923,472

 

 

$

481,380

 

 

$

27,253

 

 

$

 

 

$

(283,116

)

 

$

225,517

 

Exercise of stock options

 

 

16,930

 

 

 

80

 

 

 

(30

)

 

 

 

 

 

 

 

 

50

 

Share-based compensation expense

 

 

 

 

 

 

 

 

5,053

 

 

 

 

 

 

 

 

 

5,053

 

Issuance of common shares under the
   2020 Employee Share Purchase Plan

 

 

21,108

 

 

 

322

 

 

 

(103

)

 

 

 

 

 

 

 

 

219

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(524

)

 

 

 

 

 

(524

)

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

75,461

 

 

 

75,461