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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 September 30, 2023

OR

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

For the transition period from _________________ to ___________________

Commission File Number: 001-39335

 

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 November 3, 2023, there were 42,129,651 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 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

19

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

33

Item 4.

Controls and Procedures

33

PART II.

OTHER INFORMATION

35

Item 1.

Legal Proceedings

35

Item 1A.

Risk Factors

35

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

37

Item 3.

Defaults Upon Senior Securities

37

Item 4.

Mine Safety Disclosures

37

Item 5.

Other Information

37

Item 6.

Exhibits

38

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 (also known as 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 macroeconomic events, including the COVID-19 pandemic, 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 Hamas-Israel wars, 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 our Phase 1 clinical trials of lunresertib;
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 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, 2022, filed with the Securities and Exchange Commission (the “SEC”) on February 28, 2023.

 

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, including 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.

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,

 

 

 

2023

 

 

2022

 

ASSETS

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

 

Cash and cash equivalents

 

$

107,369

 

 

$

159,521

 

Marketable securities

 

 

142,703

 

 

 

184,420

 

Income tax receivable

 

 

15,739

 

 

 

 

Other current receivables

 

 

3,731

 

 

 

4,323

 

Prepaid expenses

 

 

5,551

 

 

 

5,715

 

Total current assets

 

 

275,093

 

 

 

353,979

 

Property and equipment, net

 

 

4,722

 

 

 

4,228

 

Operating lease right-of-use assets

 

 

3,883

 

 

 

5,371

 

Income tax receivable

 

 

2,312

 

 

 

 

Other assets

 

 

397

 

 

 

497

 

TOTAL ASSETS

 

$

286,407

 

 

$

364,075

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

 

Accounts payable

 

$

5,438

 

 

$

461

 

Accrued expenses and other current liabilities

 

 

20,729

 

 

 

21,645

 

Operating lease liability, current portion

 

 

2,333

 

 

 

2,171

 

Deferred revenue, current portion

 

 

20,472

 

 

 

53,102

 

Income tax payable

 

 

 

 

 

1,240

 

Total current liabilities

 

 

48,972

 

 

 

78,619

 

Operating lease liability, net of current portion

 

 

1,591

 

 

 

3,257

 

Deferred revenue, net of current portion

 

 

2,476

 

 

 

2,682

 

TOTAL LIABILITIES

 

 

53,039

 

 

 

84,558

 

SHAREHOLDERS’ EQUITY

 

 

 

 

 

 

Preferred shares, no par value per share; unlimited shares authorized
   as of September 30, 2023 and December 31, 2022, respectively;
0 shares issued
   and outstanding as of September 30, 2023, and December 31, 2022, respectively

 

 

 

 

 

 

Common shares, no par value per share; unlimited shares authorized as of
   September 30, 2023 and December 31, 2022;
42,129,251 and 42,036,193 shares
   issued and outstanding as of September 30, 2023 and December 31, 2022, respectively

 

 

483,184

 

 

 

482,032

 

Additional paid-in capital

 

 

55,515

 

 

 

37,226

 

Accumulated other comprehensive loss

 

 

(252

)

 

 

(428

)

Accumulated deficit

 

 

(305,079

)

 

 

(239,313

)

Total shareholders’ equity

 

 

233,368

 

 

 

279,517

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

 

$

286,407

 

 

$

364,075

 

 

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,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

Collaboration agreements

 

$

2,159

 

 

$

112,545

 

 

$

38,086

 

 

$

113,632

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development, net of tax credits

 

 

32,709

 

 

 

31,242

 

 

 

98,327

 

 

 

89,175

 

General and administrative

 

 

7,868

 

 

 

7,904

 

 

 

25,116

 

 

 

24,621

 

Total operating expenses

 

 

40,577

 

 

 

39,146

 

 

 

123,443

 

 

 

113,796

 

(Loss) income from operations

 

 

(38,418

)

 

 

73,399

 

 

 

(85,357

)

 

 

(164

)

Other income (expense), net

 

 

 

 

 

 

 

 

 

 

 

 

Realized and unrealized (loss) gain on foreign exchange

 

 

(40

)

 

 

126

 

 

 

(137

)

 

 

250

 

Interest income

 

 

3,312

 

 

 

2,027

 

 

 

10,228

 

 

 

2,700

 

Other expense

 

 

(32

)

 

 

(37

)

 

 

(73

)

 

 

(56

)

Total other income, net

 

 

3,240

 

 

 

2,116

 

 

 

10,018

 

 

 

2,894

 

(Loss) income before income taxes

 

 

(35,178

)

 

 

75,515

 

 

 

(75,339

)

 

 

2,730

 

Income tax recovery (expense)

 

 

16,299

 

 

 

(54

)

 

 

9,573

 

 

 

(119

)

Net (loss) income

 

$

(18,879

)

 

$

75,461

 

 

$

(65,766

)

 

$

2,611

 

Other comprehensive (loss) gain:

 

 

 

 

 

 

 

 

 

 

 

 

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

 

$

172

 

 

$

(524

)

 

$

176

 

 

$

(524

)

Total other comprehensive gain (loss)

 

 

172

 

 

 

(524

)

 

 

176

 

 

 

(524

)

Comprehensive (loss) income

 

$

(18,707

)

 

$

74,937

 

 

$

(65,590

)

 

$

2,087

 

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

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.45

)

 

$

1.80

 

 

$

(1.56

)

 

$

0.06

 

Diluted

 

$

(0.45

)

 

$

1.71

 

 

$

(1.56

)

 

$

0.06

 

Weighted-average common shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

42,102,685

 

 

 

41,945,617

 

 

 

42,077,857

 

 

 

41,902,554

 

Diluted

 

 

42,102,685

 

 

 

44,177,376

 

 

 

42,077,857

 

 

 

44,160,481

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

Loss

 

 

Deficit

 

 

Equity

 

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

 

Balance, September 30, 2022

 

 

41,961,510

 

 

$

481,782

 

 

$

32,173

 

 

$

(524

)

 

$

(207,655

)

 

$

305,776

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2022

 

 

42,036,193

 

 

$

482,032

 

 

$

37,226

 

 

$

(428

)

 

$

(239,313

)

 

$

279,517

 

Exercise of stock options

 

 

2,000

 

 

 

7

 

 

 

(3

)

 

 

 

 

 

 

 

 

4

 

Share-based compensation expense

 

 

 

 

 

 

 

 

6,062

 

 

 

 

 

 

 

 

 

6,062

 

Issuance of common shares under the
   2020 Employee Share Purchase Plan

 

 

41,703

 

 

 

638

 

 

 

(229

)

 

 

 

 

 

 

 

 

409

 

Other comprehensive gain

 

 

 

 

 

 

 

 

 

 

 

193

 

 

 

 

 

 

193

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(34,941

)

 

 

(34,941

)

Balance, March 31, 2023

 

 

42,079,896

 

 

$

482,677

 

 

$

43,056

 

 

$

(235

)

 

$

(274,254

)

 

$

251,244

 

Exercise of stock options

 

 

14,050

 

 

 

62

 

 

 

(22

)

 

 

 

 

 

 

 

 

40

 

Share-based compensation expense

 

 

 

 

 

 

 

 

6,265

 

 

 

 

 

 

 

 

 

6,265

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(189

)

 

 

 

 

 

(189

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(11,946

)

 

 

(11,946

)

Balance, June 30, 2023

 

 

42,093,946

 

 

$

482,739

 

 

$

49,299

 

 

$

(424

)

 

$

(286,200

)

 

$

245,414

 

Exercise of stock options

 

 

1,400

 

 

 

6

 

 

 

(2

)

 

 

 

 

 

 

 

 

4

 

Share-based compensation expense

 

 

 

 

 

 

 

 

6,377

 

 

 

 

 

 

 

 

 

6,377

 

Issuance of common shares under the
   2020 Employee Share Purchase Plan

 

 

33,905

 

 

 

439

 

 

 

(159

)

 

 

 

 

 

 

 

 

280

 

Other comprehensive gain

 

 

 

 

 

 

 

 

 

 

 

172

 

 

 

 

 

 

172

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(18,879

)

 

 

(18,879

)

Balance, September 30, 2023

 

 

42,129,251

 

 

$

483,184

 

 

$

55,515

 

 

$

(252

)

 

$

(305,079

)

 

$

233,368

 

 

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)

 

 

 

Nine Months Ended
September 30,

 

 

 

2023

 

 

2022

 

Cash Flows From Operating Activities:

 

 

 

 

 

 

Net (loss) income for the period

 

$

(65,766

)

 

$

2,611

 

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

 

 

 

 

 

 

Share-based compensation expense

 

 

18,704

 

 

 

14,553

 

Depreciation expense

 

 

1,445

 

 

 

1,523

 

Non-cash lease expense

 

 

1,637

 

 

 

1,643

 

Foreign exchange loss (gain)

 

 

71

 

 

 

(230

)

Net (accretion)/amortization of marketable securities

 

 

(5,809

)

 

 

(733

)

Deferred tax

 

 

 

 

 

(3,857

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses

 

 

167

 

 

 

676

 

Other current receivables

 

 

559

 

 

 

(10,797

)

Other non-current assets

 

 

100

 

 

 

89

 

Accounts payable

 

 

4,587

 

 

 

7,066

 

Accrued expenses and other current liabilities

 

 

(916

)

 

 

(1,291

)

Operating lease liability, current portion

 

 

117

 

 

 

536

 

Income taxes

 

 

(19,291

)

 

 

(1,152

)

Operating lease liability, net of current portion

 

 

(1,771

)

 

 

(1,672

)

Deferred revenue

 

 

(32,836

)

 

 

20,994

 

Net cash (used in) provided by operating activities

 

 

(99,002

)

 

 

29,959

 

Cash Flows From Investing Activities:

 

 

 

 

 

 

Purchases of property and equipment

 

 

(1,540

)

 

 

(2,322

)

Proceeds from maturities of marketable securities

 

 

222,000

 

 

 

6,400

 

Purchase of marketable securities

 

 

(174,298

)

 

 

(213,914

)

Net cash provided by (used in) investing activities

 

 

46,162

 

 

 

(209,836

)

Cash Flows From Financing Activities:

 

 

 

 

 

 

Proceeds from exercise of stock options

 

 

48

 

 

 

283

 

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