10-Q
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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 March 31, 2024

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.)

7171 Frederick-Banting, Building 2, Suite 270

St-Laurent, Québec, Canada

H4S 1Z9

(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 May 3, 2024, there were 42,445,406 of the registrant’s common shares, no par value per share, outstanding.

 

 


 

Table of Contents

 

Page

SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS

1

PART I.

FINANCIAL INFORMATION

3

Item 1.

Financial Statements (Unaudited)

3

Condensed Consolidated Balance Sheets

3

Condensed Consolidated Statements of Operations and Comprehensive Income (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

16

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

28

Item 4.

Controls and Procedures

29

PART II.

OTHER INFORMATION

30

Item 1.

Legal Proceedings

30

Item 1A.

Risk Factors

30

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

30

Item 3.

Defaults Upon Senior Securities

30

Item 4.

Mine Safety Disclosures

30

Item 5.

Other Information

30

Item 6.

Exhibits

31

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 lunresertib, camonsertib 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;
the evolving impact of macroeconomic events, including health pandemics, changes in inflation, the U.S. Federal Reserve raising interest rates, disruptions in access to bank deposits or lending commitments due to bank failures and the Russia-Ukraine and Middle-East conflicts, on our operations, supply chains, general economic conditions, our ability to raise additional capital, and the continuity of our business, including our preclinical studies and clinical trials;
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 ongoing clinical trials of lunresertib, camonsertib and RP-1664;
the expected timing of filings with regulatory authorities for any product candidates that we develop;
our expectations regarding the potential market size and the rate and degree of market acceptance for any current or future product candidates that we develop;
our ability to receive any milestone or royalty payments under our collaboration and license agreements;
the anticipated impact of the termination of our collaboration with Hoffmann-La Roche Inc. and F. Hoffmann-La Roche Ltd for the development and commercialization of camonsertib, including our expectations regarding the development of camonsertib following the transition of commercial and development rights in camonsertib back to us;
our ability to realize the benefits of the collaboration compounds retained by us following the termination of our collaboration with F. Hoffmann-La Roche Ltd and Hoffman-La Roche Inc.;
the effects of competition with respect to lunresertib, camonsertib, 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 and elsewhere in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the Securities and Exchange Commission (the “SEC”) on February 28, 2024.

 

 


 

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 macroeconomic events 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.

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
March 31,

 

 

As of
December 31,

 

 

 

2024

 

 

2023

 

ASSETS

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

 

Cash and cash equivalents

 

$

103,217

 

 

$

111,268

 

Marketable securities

 

 

133,784

 

 

 

112,359

 

Income tax receivable

 

 

10,829

 

 

 

10,813

 

Other current receivables

 

 

3,377

 

 

 

4,499

 

Prepaid expenses

 

 

3,463

 

 

 

4,749

 

Total current assets

 

 

254,670

 

 

 

243,688

 

Property and equipment, net

 

 

3,714

 

 

 

4,215

 

Operating lease right-of-use assets

 

 

2,763

 

 

 

3,326

 

Income tax receivable

 

 

1,630

 

 

 

2,276

 

Other assets

 

 

307

 

 

 

396

 

TOTAL ASSETS

 

$

263,084

 

 

$

253,901

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

 

Accounts payable

 

$

6,825

 

 

$

2,400

 

Accrued expenses and other current liabilities

 

 

20,454

 

 

 

24,057

 

Operating lease liability, current portion

 

 

2,218

 

 

 

2,400

 

Deferred revenue, current portion

 

 

1,073

 

 

 

10,222

 

Total current liabilities

 

 

30,570

 

 

 

39,079

 

Operating lease liability, net of current portion

 

 

561

 

 

 

1,010

 

Deferred revenue, net of current portion

 

 

 

 

 

1,730

 

TOTAL LIABILITIES

 

 

31,131

 

 

 

41,819

 

SHAREHOLDERS’ EQUITY

 

 

 

 

 

 

Preferred shares, no par value per share; unlimited shares authorized
   as of March 31, 2024 and December 31, 2023, respectively;
0 shares issued
   and outstanding as of March 31, 2024, and December 31, 2023, respectively

 

 

 

 

 

 

Common shares, no par value per share; unlimited shares authorized as of
   March 31, 2024 and December 31, 2023;
42,445,406 and 42,176,041 shares
   issued and outstanding as of March 31, 2024 and December 31, 2023, respectively

 

 

486,375

 

 

 

483,350

 

Additional paid-in capital

 

 

65,638

 

 

 

61,813

 

Accumulated other comprehensive (loss) income

 

 

(113

)

 

 

28

 

Accumulated deficit

 

 

(319,947

)

 

 

(333,109

)

Total shareholders’ equity

 

 

231,953

 

 

 

212,082

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

 

$

263,084

 

 

$

253,901

 

 

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 Income (Loss)

(Unaudited)

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

 

 

 

Three Months Ended
March 31,

 

 

 

2024

 

 

2023

 

Revenue:

 

 

 

 

 

 

Collaboration agreements

 

$

52,404

 

 

$

5,678

 

Operating expenses:

 

 

 

 

 

 

Research and development, net of tax credits

 

 

32,970

 

 

 

31,830

 

General and administrative

 

 

8,618

 

 

 

8,529

 

Total operating expenses

 

 

41,588

 

 

 

40,359

 

Income (loss) from operations

 

 

10,816

 

 

 

(34,681

)

Other income (expense), net

 

 

 

 

 

 

Realized and unrealized gain (loss) on foreign exchange

 

 

31

 

 

 

(56

)

Interest income

 

 

2,968

 

 

 

3,427

 

Other expense

 

 

(24

)

 

 

(15

)

Total other income, net

 

 

2,975

 

 

 

3,356

 

Income (loss) before income taxes

 

 

13,791

 

 

 

(31,325

)

Income tax expense

 

 

(629

)

 

 

(3,616

)

Net income (loss)

 

$

13,162

 

 

$

(34,941

)

Other comprehensive (loss) income:

 

 

 

 

 

 

Unrealized (loss) gain on available-for-sale marketable securities

 

$

(141

)

 

$

193

 

Total other comprehensive (loss) income

 

 

(141

)

 

 

193

 

Comprehensive income (loss)

 

$

13,021

 

 

$

(34,748

)

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

 

 

 

 

 

 

Basic

 

$

0.31

 

 

$

(0.83

)

Diluted

 

$

0.30

 

 

$

(0.83

)

Weighted-average common shares outstanding:

 

 

 

 

 

 

Basic

 

 

42,234,001

 

 

 

42,040,674

 

Diluted

 

 

44,024,198

 

 

 

42,040,674

 

 

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

 

 

Accumulated
Other Comprehensive

 

 

Accumulated

 

 

Total
Shareholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

Balance,
   December 31, 2022

 

 

42,036,193

 

 

$

482,032

 

 

$

37,226

 

 

$

(428

)

 

$

(239,313

)

 

$

279,517

 

Share-based compensation
   expense

 

 

 

 

 

 

 

 

6,062

 

 

 

 

 

 

 

 

 

6,062

 

Exercise of stock options

 

 

2,000

 

 

 

7

 

 

 

(3

)

 

 

 

 

 

 

 

 

4

 

Issuance of common shares
   under the 2020 Employee
   Share Purchase Plan

 

 

41,703

 

 

 

638

 

 

 

(229

)

 

 

 

 

 

 

 

 

409

 

Other comprehensive
   income

 

 

 

 

 

 

 

 

 

 

 

193

 

 

 

 

 

 

193

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(34,941

)

 

 

(34,941

)

Balance, March 31, 2023

 

 

42,079,896

 

 

$

482,677

 

 

$

43,056

 

 

$

(235

)

 

$

(274,254

)

 

$

251,244

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance,
   December 31, 2023

 

 

42,176,041

 

 

$

483,350

 

 

$

61,813

 

 

$

28

 

 

$

(333,109

)

 

$

212,082

 

Share-based compensation
   expense

 

 

 

 

 

 

 

 

6,475

 

 

 

 

 

 

 

 

 

6,475

 

Exercise of stock options

 

 

8,485

 

 

 

27

 

 

 

(10

)

 

 

 

 

 

 

 

 

17

 

Issuance of common shares
   on vesting of restricted
   share units

 

 

200,262

 

 

 

2,488

 

 

 

(2,488

)

 

 

 

 

 

 

 

 

 

Issuance of common shares
   under the 2020 Employee
   Share Purchase Plan

 

 

60,618

 

 

 

510

 

 

 

(152

)

 

 

 

 

 

 

 

 

358

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(141

)

 

 

 

 

 

(141

)

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

13,162

 

 

 

13,162

 

Balance, March 31, 2024

 

 

42,445,406

 

 

$

486,375

 

 

$

65,638

 

 

$

(113

)

 

$

(319,947

)

 

$

231,953

 

 

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

5


 

Repare Therapeutics Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(Amounts in thousands of U.S. dollars)

 

 

 

Three Months Ended
March 31,

 

 

 

2024

 

 

2023

 

Cash Flows From Operating Activities:

 

 

 

 

 

 

Net income (loss) for the period

 

$

13,162

 

 

$

(34,941

)

Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:

 

 

 

 

 

 

Share-based compensation expense

 

 

6,475

 

 

 

6,062

 

Depreciation expense

 

 

501

 

 

 

441

 

Non-cash lease expense

 

 

563

 

 

 

541

 

Foreign exchange (gain) loss

 

 

(22

)

 

 

66

 

Net accretion of marketable securities

 

 

(1,245

)

 

 

(1,839

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses

 

 

1,286

 

 

 

1,330

 

Other current receivables

 

 

1,110

 

 

 

(2,741

)

Other non-current assets

 

 

89

 

 

 

89

 

Accounts payable

 

 

4,431

 

 

 

2,016

 

Accrued expenses and other current liabilities

 

 

(3,587

)

 

 

(4,203

)

Operating lease liability, current portion

 

 

(153

)

 

 

35

 

Income taxes

 

 

630

 

 

 

3,616

 

Operating lease liability, net of current portion

 

 

(429

)

 

 

(581

)

Deferred revenue

 

 

(10,879

)

 

 

(1,677

)

Net cash provided by (used in) operating activities

 

 

11,932

 

 

 

(31,786

)

Cash Flows From Investing Activities:

 

 

 

 

 

 

Purchases of property and equipment

 

 

 

 

 

(475

)

Proceeds from maturities of marketable securities

 

 

69,015

 

 

 

92,500

 

Purchase of marketable securities

 

 

(89,331

)

 

 

(98,711

)

Net cash used in investing activities

 

 

(20,316

)

 

 

(6,686

)

Cash Flows From Financing Activities:

 

 

 

 

 

 

Proceeds from exercise of stock options

 

 

17

 

 

 

4

 

Proceeds from issuance of common stock under the 2020 Employee Share Purchase Plan

 

 

358

 

 

 

409

 

Net cash provided by financing activities

 

 

375

 

 

 

413

 

Effect of exchange rate fluctuations on cash held

 

 

(42

)

 

 

(1

)

Net Decrease In Cash And Cash Equivalents

 

 

(8,051

)

 

 

(38,060

)

Cash and cash equivalents at beginning of period

 

 

111,268

 

 

 

159,521

 

Cash and cash equivalents at end of period

 

$

103,217

 

 

$

121,461

 

 

 

 

 

 

 

Supplemental Disclosure Of Cash Flow Information:

 

 

 

 

 

 

Property and equipment purchases incurred but not yet paid

 

$

 

 

$

1,134

 

Right-of-use asset obtained in exchange for new operating lease liability

 

$

 

 

$

146

 

 

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

6


 

REPARE THERAPEUTICS INC.

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Amounts in U.S. dollars, unless otherwise specified)

1. Organization and Nature of Business

Repare Therapeutics Inc. (“Repare” or the “Company”) is a precision medicine oncology company focused on the development of synthetic lethality-based therapies for patients with cancer. The Company is governed by the Business Corporations Act (Québec). The Company’s common shares are listed on the Nasdaq Global Select Market under the ticker symbol “RPTX”.

2. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and as amended by Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”).

The unaudited condensed consolidated financial statements have been prepared on the same basis as the audited annual consolidated financial statements as of and for the year ended December 31, 2023, and, in the opinion of management, reflect all adjustments, consisting of normal recurring adjustments, necessary for the fair presentation of the Company’s consolidated financial position as of March 31, 2024, the consolidated results of its operations for the three months ended March 31, 2024 and 2023, its statements of shareholders’ equity for the three months ended March 31, 2024 and 2023 and its consolidated cash flows for the three months ended March 31, 2024 and 2023.

These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the accompanying notes for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission (the “SEC”) on February 28, 2024 (the “Annual Report”). The condensed consolidated balance sheet data as of December 31, 2023 presented for comparative purposes was derived from the Company’s audited consolidated financial statements but does not include all disclosures required by U.S. GAAP. The results for the three months ended March 31, 2024 are not necessarily indicative of the operating results to be expected for the full year or for any other subsequent interim period.

The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2023 included in the Annual Report. There have been no changes to the Company's significant accounting policies since the date of the audited consolidated financial statements for the year ended December 31, 2023 included in the Annual Report.

Principles of Consolidation

These unaudited condensed consolidated financial statements of the Company include the accounts of the Company and its wholly-owned subsidiary, Repare Therapeutics USA Inc. (“Repare USA”), which was incorporated under the laws of Delaware on June 1, 2017. The financial statements of Repare USA are prepared for the same reporting period as the parent company, using consistent accounting policies. All intra-group transactions, balances, income, and expenses are eliminated in full upon consolidation.

Use of Estimates

The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in consolidated financial statements and accompanying notes. Significant estimates and assumptions reflected in these unaudited condensed consolidated financial statements include, but are not limited to, estimates related to revenue recognition, accrued research and development expenses, share-based compensation and income taxes. The Company bases its estimates on historical experience and other market specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results could differ from those estimates. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known.

Recently Issued Accounting Pronouncements Not Yet Adopted

In November 2023, the FASB amended the guidance in ASU 280, Segment Reporting, to require a public entity to disclose significant segment expenses and other segment items on an annual and interim basis and provide in interim periods all disclosures about a reportable segment’s profit or loss and assets that are currently required annually. Public entities with a single reportable segment

7


 

are required to provide the new disclosures and all the disclosures currently required under ASC 280. The new guidance is effective for public entities in fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. The Company is currently assessing the impact of this amendment on its consolidated financial statements.

In December 2023, the FASB amended the guidance in ASU 740, Income Taxes, to provide disaggregated income tax disclosures on the rate reconciliation and income taxes paid. The new guidance is effective for public entities in fiscal years beginning after 15 December 2024. Early adoption is permitted. The Company is currently assessing the impact of this amendment on its consolidated financial statements.

3. Cash and Cash Equivalents and Marketable Securities

Cash and cash equivalents and marketable securities were comprised of the following:

 

 

Amortized Cost

 

 

Unrealized Gains

 

 

Unrealized Losses

 

 

Fair Value

 

 

 

(in thousands)

 

As of March 31, 2024

 

 

 

 

 

 

 

 

 

 

 

 

 Cash and cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

 Cash

 

$

48,706

 

 

$

 

 

$

 

 

$

48,706

 

 Money market funds

 

 

44,558

 

 

 

 

 

 

 

 

 

44,558

 

 Commercial paper

 

 

9,954

 

 

 

 

 

 

(1

)

 

 

9,953

 

 Total cash and cash equivalents:

 

$

103,218

 

 

$

 

 

$

(1

)

 

$

103,217

 

 Marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

 Commercial paper

 

$

117,197

 

 

$

16

 

 

$

(113

)

 

$

117,100

 

 Corporate debt securities

 

 

16,699

 

 

 

 

 

 

(15

)

 

 

16,684

 

 Total marketable securities

 

$

133,896

 

 

$

16

 

 

$

(128

)

 

$

133,784

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As of December 31, 2023

 

 

 

 

 

 

 

 

 

 

 

 

 Cash and cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

 Cash

 

$

44,462

 

 

$

 

 

$

 

 

$

44,462

 

 Money market funds

 

 

36,991

 

 

 

 

 

 

 

 

 

36,991

 

 Commercial paper

 

 

29,811

 

 

 

4

 

 

 

 

 

 

29,815

 

 Total cash and cash equivalents:

 

$

111,264

 

 

$

4

 

 

$

 

 

$

111,268

 

 Marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

 U.S. Treasury and government-sponsored enterprises

 

$

22,434

 

 

$

 

 

$

(25

)

 

$

22,409

 

 Commercial paper

 

 

89,901

 

 

 

60

 

 

 

(11

)

 

 

89,950

 

 Total marketable securities

 

$

112,335

 

 

$

60

 

 

$

(36

)

 

$

112,359

 

Interest receivable was $0.4 million and $0.4 million as of March 31, 2024 and December 31, 2023, respectively, and is included in other current receivables.

The Company held available-for-sale marketable securities with an aggregate fair value of $109.3 million and $58.6 million that were in an immaterial, unrealized loss position as of March 31, 2024 and December 31, 2023, respectively, as shown in the table above. These marketable securities have been in an unrealized loss position for less than twelve months. The unrealized losses as of March 31, 2024 and December 31, 2023, were not attributed to credit risk but were primarily associated with changes in interest rates and market liquidity. The Company does not intend to sell these securities and it is more likely than not that it will hold these investments for a period of time sufficient to recover the amortized cost. As a result, the Company did not record an allowance for credit losses or other impairment charges for its marketable securities for the three months ended March 31, 2024 and 2023.

The Company recognized a net unrealized loss of $0.1 million and a net unrealized gain of $0.2 million in other comprehensive (loss) income in the three months ended March 31, 2024 and 2023, respectively, in relation to its cash and cash equivalents and marketable securities.

The maturities of the Company’s marketable securities as of March 31, 2024 and December 31, 2023 are less than one year.

8


 

4. Fair Value Measurements

Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:

Level 1 – Quoted prices in active markets for identical assets or liabilities.
Level 2 – Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.
Level 3 – Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.

The following table presents information about the Company’s financial assets measured at fair value on a recurring basis and indicates the level of the fair value hierarchy utilized to determine such fair values:

Description

 

Financial Assets

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

 

(in thousands)

 

As of March 31, 2024

 

 

 

 

 

 

 

 

 

 

 

 

 Assets

 

 

 

 

 

 

 

 

 

 

 

 

 Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

 Money market funds

 

$

44,558

 

 

$

44,558

 

 

$

 

 

$

 

 Commercial paper

 

 

9,953

 

 

 

 

 

 

9,953

 

 

 

 

 Total cash equivalents

 

 

54,511

 

 

 

44,558

 

 

 

9,953

 

 

 

 

 Marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

 Commercial paper

 

 

117,100

 

 

 

 

 

 

117,100

 

 

 

 

 Corporate debt securities

 

 

16,684

 

 

 

 

 

 

16,684

 

 

 

 

 Total marketable securities

 

 

133,784

 

 

 

 

 

 

133,784

 

 

 

 

 Total financial assets

 

$

188,295

 

 

$

44,558

 

 

$

143,737

 

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As of December 31, 2023

 

 

 

 

 

 

 

 

 

 

 

 

 Assets

 

 

 

 

 

 

 

 

 

 

 

 

 Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

 Money market funds

 

$

36,991

 

 

$

36,991

 

 

$

 

 

$

 

 Commercial paper

 

 

29,815

 

 

 

 

 

 

29,815

 

 

 

 

 Total cash equivalents

 

 

66,806

 

 

 

36,991

 

 

 

29,815

 

 

 

 

 Marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

 U.S. Treasury and government-sponsored enterprises

 

 

22,409

 

 

 

 

 

 

22,409

 

 

 

 

 Commercial paper

 

 

89,950

 

 

 

 

 

 

89,950

 

 

 

 

 Total marketable securities

 

 

112,359

 

 

 

 

 

 

112,359

 

 

 

 

 Total financial assets

 

$

179,165

 

 

$

36,991

 

 

$

142,174

 

 

$

 

When developing fair value estimates, the Company maximizes the use of observable inputs and minimizes the use of unobservable inputs. When available, the Company uses quoted market prices to measure the fair value. In determining the fair values at each date presented above, the Company relied on quoted prices for similar securities in active markets or using other inputs that are observable or can be corroborated by observable market data.

During the three months ended March 31, 2024, there were no transfers between fair value measure levels.

9


 

5. Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities as of March 31, 2024 and December 31, 2023 consisted of the following:

 

 

March 31,
2024

 

 

December 31,
2023

 

 

 

(in thousands)

 

Accrued research and development expense

 

$

16,443

 

 

$

16,251

 

Accrued compensation and benefits

 

 

2,739

 

 

 

6,981

 

Accrued professional services

 

 

671

 

 

 

631

 

Other

 

 

601

 

 

 

194

 

Total accrued expenses and other current liabilities

 

$

20,454

 

 

$

24,057

 

 

6. Collaborative Arrangements

Debiopharm Clinical Study and Collaboration Agreement

In January 2024, the Company entered into a clinical study and collaboration agreement with Debiopharm International S.A. (“Debiopharm”), a privately-owned, Swiss-based biopharmaceutical company, with the aim to explore the synergy between the Company’s compound, lunresertib, and Debiopharm’s compound, Debio 0123, a WEE1 inhibitor (the “Debio collaboration agreement”). The Company and Debiopharm are collaborating on the development of a combination therapy, with the Company sponsoring the global study, and will share all costs equally. The Company and Debiopharm are each supplying their respective drugs and retain all commercial rights to their respective compounds, including as monotherapy or as combination therapies. The activities associated with the collaboration are coordinated by a joint steering committee, which is comprised of an equal number of representatives from the Company and Debiopharm.

Based on the terms of the Debio collaboration agreement, the Company concluded that the Debio collaboration agreement meets the requirements of a collaboration within the guidance of ASC 808, Collaborative Arrangements, as both parties are active participants in the combination trial and are exposed to significant risks and rewards depending on the success of the combination trial. Accordingly, the net costs associated with the co-development are expensed as incurred and recognized within research and development expenses in the consolidated statement of operations and comprehensive income (loss).

During the three-month period ended March 31, 2024, the Company recognized $0.5 million in net research and development costs with regards to the Debio collaboration agreement and recorded a receivable from Debiopharm of $0.5 million in other current receivables, reflecting the 50/50 cost sharing terms.

7. Revenue recognition from Collaboration and License Agreements

The following table presents revenue from collaboration agreements:

 

 

Three Months Ended
March 31,

 

 

 

2024

 

 

2023

 

 

 

(in thousands)

 

Roche Collaboration and License Agreement

 

$

49,815

 

 

$

5,312

 

Bristol-Myers Squibb Collaboration and License Agreement

 

 

2,589

 

 

 

366

 

Total revenue

 

$

52,404

 

 

$

5,678

 

The Company’s revenue recognition accounting policy, as well as additional information on the Company’s collaboration and license agreements are disclosed in the audited consolidated financial statements for the year ended December 31, 2023 included in the Annual Report.

Roche Collaboration and License Agreement

In June 2022, the Company entered into a collaboration and license agreement (the “Roche Agreement”) with Hoffmann-La Roche Inc. and F. Hoffmann-La Roche Ltd (collectively, “Roche”) regarding the development and commercialization of the Company’s product candidate camonsertib (also known as RP-3500) and specified other Ataxia-Telangiectasia and Rad3-related protein kinase (“ATR”) inhibitors (the “Licensed Products”) which became effective July 13, 2022 (the “Effective Date”). Pursuant to the Roche Agreement, the Company granted Roche a worldwide, perpetual, exclusive, sublicensable license to develop, manufacture, and

10


 

commercialize the Licensed Products, as well as a non-exclusive, sublicensable license to certain related companion diagnostics. The Company agreed to complete specified ongoing clinical trials in accordance with the development plan in the Roche Agreement, as well as ongoing investigator sponsored trials (together, the “Continuing Trials”) at the Company’s expense. Roche assumed all subsequent development of camonsertib with the potential to expand development into additional tumors and multiple combination studies. The Company retained the right to conduct specified clinical trials (the “Repare Trials”) of camonsertib in combination with the Company’s PKMYT1 compound, lunresertib (also known as RP-6306). The Roche Agreement provided the Company, at its sole discretion, with the ability to opt-in to a 50/50 U.S. co-development and profit share arrangement, including participation in U.S. co-promotion if U.S. regulatory approval was received. If the Company chose to exercise its co-development and profit share option, it would continue to be eligible to receive certain clinical, regulatory, commercial and sales milestone payments, in addition to full ex-U.S. royalties.

On February 7, 2024, the Company received written notice from Roche of their election to terminate the Roche Agreement following a review of Roche’s pipeline and evolving external factors. The termination became effective May 7, 2024, at which time the Company regained global development and commercialization rights for camonsertib from Roche.

In March 2024, the Company received a payment of $4.0 million for revisions to the clinical development plan under the Roche Agreement, of which $2.1 million was previously recorded as a receivable at December 31, 2023. The transaction price was updated for this additional consideration received, as well as other adjustments of $0.5 million pursuant to the termination of the agreement.

In February 2024, the Company further received a $40.0 million milestone payment from Roche that was earned upon dosing of the first patient with camonsertib in Roche’s Phase 2 TAPISTRY trial in January 2024.

Deferred revenue pertaining to the Roche Agreement

 

Completion of Continuing Trials

 

 

 

(in thousands)

 

Balance as of December 31, 2023

 

$

9,463

 

Increase in collaboration revenue

 

 

41,425

 

Recognition as revenue, as the result of performance obligations satisfied

 

 

(49,815

)

Balance as of March 31, 2024

 

$

1,073

 

Classified as short-term

 

$

1,073

 

The Company recognized $49.8 million and $5.3 million for the three months ended March 31, 2024 and 2023, respectively as revenue associated with the Roche Agreement in relation to (i) the recognition of revenue upon the $40.0 million milestone achievement in the first quarter of 2024, as well as (ii) the partial recognition of deferred revenue for research and development services performed towards the completion of the Continuing Trials during the period.

As of March 31, 2024, there was $1.1 million (December 31, 2023 - $9.4 million) of deferred revenue related to the Roche Agreement, of which $1.1 million (December 31, 2023 - $7.7 million) was classified as current and nil (December 31, 2023 - $1.7 million) was classified as non-current in the condensed consolidated balance sheet based on the period the services to complete the Continuing Trials are expected to be performed. All deferred revenue related to the Roche Agreement is expected to be recognized in the second quarter of 2024 pursuant to the termination.

Bristol-Myers Squibb Collaboration and License Agreement

In May 2020, the Company entered into a collaboration and license agreement (the “BMS Agreement”) with Bristol-Myers Squibb Company (“Bristol-Myers Squibb”), pursuant to which the Company and Bristol-Myers Squibb have agreed to collaborate in the research and development of potential new product candidates for the treatment of cancer. The Company provided Bristol-Myers Squibb access to a selected number of its existing screening campaigns and novel campaigns. The Company was responsible for carrying out early-stage research activities directed to identifying potential targets for potential licensing by Bristol-Myers Squibb, in accordance with a mutually agreed upon research plan, and was solely responsible for such costs. The collaboration consisted of programs directed to both druggable targets and to targets commonly considered undruggable to traditional small molecule approaches. Upon Bristol-Myers Squibb’s election to exercise its option to obtain exclusive worldwide licenses for the subsequent development, manufacturing and commercialization of a program, Bristol-Myers Squibb will then be solely responsible for all such worldwide activities and costs.

Although the collaboration term expired in November 2023, the BMS Agreement will not expire until, on a licensed product-by-licensed product and country-by-country basis, the expiration of the applicable royalty term and in its entirety upon expiration of the last royalty term. Either party may terminate earlier upon an uncured material breach of the agreement by the other party, or the

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insolvency of the other party. Additionally, Bristol-Myers Squibb may terminate the BMS Agreement for any or no reason on a program-by-program basis upon specified written notice.

The Company is entitled to receive up to $301.0 million in total milestones on a program-by-program basis, consisting of $176.0 million in the aggregate for certain specified research, development and regulatory milestones and $125.0 million in the aggregate for certain specified commercial milestones. The Company is further entitled to a tiered percentage royalty on annual net sales ranging from high-single digits to low-double digits, subject to certain specified reductions.

Deferred revenue pertaining to the BMS Agreement

 

Options to license undruggable targets

 

 

 

(in thousands)

 

Balance as of December 31, 2023

 

$

2,489

 

Increase in collaboration revenue

 

 

100

 

Recognition as revenue, as the result of performance obligations satisfied

 

 

(2,589

)

Balance as of March 31, 2024

 

$

 

In March 2024, Bristol-Myers Squibb exercised its one remaining option for an undruggable target. As a result, the Company recognized $2.6 million as revenue related to undruggable targets, including the option fee payment of $0.1 million.

8. Leases

The Company has historically entered into lease arrangements for its facilities. As of March 31, 2024, the Company had four operating leases with required future minimum payments. The Company’s leases generally do not include termination or purchase options.

Operating Leases

The following tables contain a summary of the lease costs recognized under ASC 842 and other information pertaining to the Company’s operating leases:

 

 

Three Months Ended
March 31,

 

 

 

2024

 

 

2023

 

 

 

(in thousands)

 

Operating Leases - Lease Costs

 

 

 

 

 

 

Operating lease costs

 

$

594

 

 

$

592

 

Short-term lease costs

 

 

19

 

 

 

14

 

Variable lease costs

 

 

85

 

 

 

40

 

Total lease costs

 

$

698

 

 

$

646

 

 

 

 

Three Months Ended
March 31,

 

 

 

2024

 

 

2023

 

 

 

(in thousands, except as specified otherwise)

 

Other Operating Lease Information

 

 

 

 

 

 

Operating cash flows used for operating leases

 

$

613

 

 

$

599

 

Right-of-use assets obtained in exchange for new operating lease liability

 

$

 

 

$

146

 

Weighted-average remaining lease term (in years)

 

 

1.23

 

 

 

2.19

 

Weighted-average discount rate

 

 

4.2

%

 

 

4.1

%

 

9. Share-Based Compensation

2020 Employee Share Purchase Plan

In June 2020, the Company’s board of directors adopted, and the Company’s shareholders approved the 2020 Employee Share Purchase Plan (“ESPP”). The number of shares reserved and available for issuance under the ESPP will automatically increase each January 1, beginning on January 1, 2021 and each January 1 thereafter through January 31, 2030, by the lesser of (1) 1.0% of the total number of common shares outstanding on December 31 of the preceding calendar year, (2) 3,300,000 common shares, or (3) such

12


 

smaller number of common shares as the Company’s board of directors may designate. As of March 31, 2024, the number of common shares that may be issued under the ESPP is 1,772,568.

The ESPP enables eligible employees to purchase common shares of the Company at the end of each offering period at a price equal to 85% of the fair market value of the shares on the first business day or the last business day of the offering period, whichever is lower. Participation in the ESPP is voluntary. Eligible employees become participants in the ESPP by enrolling in the plan and authorizing payroll deductions. At the end of each offering period, accumulated payroll deductions are used to purchase the Company’s shares at the discounted price. The Company makes no contributions to the ESPP. A participant may withdraw from the ESPP or suspend contributions to the ESPP. If the participant elects to withdraw during an offering, all contributions are refunded as soon as administratively practicable. If a participant elects to withdraw or suspend contributions, they will not be able to re-enroll in the current offering but may elect to participate in future offerings. A participant may only purchase whole shares of the Company’s common shares in the ESPP. ESPP offering periods are offered on a rolling six-month basis.

The Company issued 60,618 common shares under the ESPP for the three months ended March 31, 2024, at a weighted-average price per share of $5.91, for aggregate proceeds of $0.4 million.

Option Plan and 2020 Plan

In December 2016, as further amended in December 2017 and September 2019, the Company adopted the Repare Therapeutics Inc. Option Plan (the “Option Plan”) for the issuance of stock options and other share-based awards to directors, officers, employees or consultants. The Option Plan authorized up to 4,074,135 shares of the Company’s common shares to be issued.

In June 2020, the Company’s board of directors adopted, and the Company’s shareholders approved the 2020 Equity Incentive Plan (the “2020 Plan”). The 2020 Plan became effective on the effective date of the IPO, at which time the Company ceased making awards under the Option Plan. The 2020 Plan allows the Company’s compensation committee to make equity-based and cash-based incentive awards to the Company’s officers, employees, directors and consultants including but not limited to stock options and restricted share units. The aggregate number of common shares reserved and available for issuance under the 2020 Plan has automatically increased on January 1 of each year beginning on January 1, 2021 and will continue to increase on January 1 of each year through and including January 1, 2030, by 5% of the outstanding number of common shares on the immediately preceding December 31, or such lesser number of shares as determined by the Company’s board of directors. As of March 31, 2024, the number of common shares reserved for issuance under the 2020 Plan is 12,136,183.

The exercise price per share of a stock option must be at least equal to the fair value of the common shares on the date of grant, as determined by the Company’s compensation committee or the Company’s board of directors. Stock options awarded under the 2020 Plan expire 10 years after the grant. Unless otherwise stated in a stock option agreement, options generally have vesting conditions of 25% of the shares subject to an option grant typically vesting upon the first anniversary of the vesting start date and thereafter at the rate of one forty-eighth of the option shares per month as of the first day of each month after the first anniversary.

Inducement Plan

In April 2024, the Company’s board of directors approved the adoption of the 2024 Inducement Plan (the “Inducement Plan”), to be used exclusively for grants of awards to individuals who were not previously employees or directors (or following a bona fide period of non-employment) as a material inducement to such individuals’ entry into employment with the Company, pursuant to Nasdaq Listing Rule 5635(c)(4). The terms and conditions of the Inducement Plan are substantially similar to those of the 2020 Plan. 350,000 common shares have been reserved for issuance under the Inducement Plan.

Stock Options

The following table summarizes the Company’s stock options activity:

 

 

Number of
shares

 

 

Weighted
average
exercise price

 

Outstanding, January 1, 2024

 

 

10,097,771

 

 

$

13.77

 

Granted

 

 

1,376,682

 

 

$

6.95

 

Exercised

 

 

(8,485

)

 

$

1.99

 

Cancelled or forfeited

 

 

(145,179

)

 

$

16.74

 

Outstanding, March 31, 2024

 

 

11,320,789

 

 

$

12.91

 

 

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During the three months ended March 31, 2024, an aggregate of 8,485 options were exercised at a weighted-average exercise price of $1.99 per share.

The fair value of stock options, and the assumptions used in the Black Scholes option-pricing model to determine the grant date fair value of stock options granted to employees and non-employees were as follows, presented on a weighted average basis:

 

 

Three Months Ended
March 31,

 

 

 

2024

 

 

2023

 

 

 

 

 

 

 

 

Fair value of stock options

 

$

5.08

 

 

$

8.85

 

Risk-free interest rate

 

 

4.19

%

 

 

3.65

%

Expected terms (in years)

 

 

6.08

 

 

 

6.08

 

Expected volatility

 

 

82.99

%

 

 

81.77

%

Expected dividend yield

 

 

0.00

%

 

 

0.00

%

Restricted Share Units

The following table summarizes the Company’s restricted share unit activity:

 

 

Number of
shares

 

 

Weighted
average
grant date fair value

 

Outstanding, January 1, 2024

 

 

603,685

 

 

$

12.42

 

Awarded

 

 

527,273

 

 

$

6.95

 

Vested and released

 

 

(200,262

)

 

$

12.42

 

Forfeited

 

 

(3,392

)

 

$

12.42

 

Outstanding, March 31, 2024

 

 

927,304

 

 

$

9.31

 

The fair value of each restricted share unit is estimated on the date of grant based on the fair value of our common shares on that same date.

Share-Based Compensation

Share-based compensation expense for all awards was allocated as follows:

 

 

Three Months Ended
March 31,

 

 

 

2024

 

 

2023

 

 

 

(in thousands)

 

Research and development

 

$

3,419

 

 

$

3,219

 

General and administrative

 

 

3,056

 

 

 

2,843

 

Total share-based compensation expense

 

$

6,475

 

 

$

6,062

 

Share-based compensation expense by type of award was as follows:

 

 

Three Months Ended
March 31,

 

 

 

2024

 

 

2023

 

 

 

(in thousands)

 

Stock options

 

$

5,685

 

 

$

5,537

 

Restricted share units

 

 

709

 

 

 

425

 

ESPP

 

 

81

 

 

 

100

 

Total share-based compensation expense

 

$

6,475

 

 

$

6,062

 

As of March 31, 2024, there was $38.6 million and $8.1 million of unrecognized share-based compensation expense to be recognized over a weighted average period of 1.6 years and 2.5 years related to unvested stock options and unvested restricted share units, respectively.

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11. Net Income (Loss) per Share

The following table summarizes the computation of basic and diluted net income (loss) per share attributable to common shareholders of the Company:

 

 

Three Months Ended
March 31,

 

 

 

2024