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 June 30, 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 August 2, 2024, there were 42,445,533 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

16

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

30

Item 4.

Controls and Procedures

30

PART II.

OTHER INFORMATION

32

Item 1.

Legal Proceedings

32

Item 1A.

Risk Factors

32

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

33

Item 3.

Defaults Upon Senior Securities

33

Item 4.

Mine Safety Disclosures

33

Item 5.

Other Information

33

Item 6.

Exhibits

34

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
June 30,

 

 

As of
December 31,

 

 

 

2024

 

 

2023

 

ASSETS

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

 

Cash and cash equivalents

 

$

79,820

 

 

$

111,268

 

Marketable securities

 

 

128,303

 

 

 

112,359

 

Income tax receivable

 

 

11,072

 

 

 

10,813

 

Other current receivables

 

 

3,571

 

 

 

4,499

 

Prepaid expenses

 

 

5,773

 

 

 

4,749

 

Total current assets

 

 

228,539

 

 

 

243,688

 

Property and equipment, net

 

 

3,226

 

 

 

4,215

 

Operating lease right-of-use assets

 

 

2,195

 

 

 

3,326

 

Income tax receivable

 

 

1,077

 

 

 

2,276

 

Other assets

 

 

307

 

 

 

396

 

TOTAL ASSETS

 

$

235,344

 

 

$

253,901

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

 

Accounts payable

 

$

7,182

 

 

$

2,400

 

Accrued expenses and other current liabilities

 

 

22,310

 

 

 

24,057

 

Operating lease liability, current portion

 

 

1,957

 

 

 

2,400

 

Deferred revenue, current portion

 

 

 

 

 

10,222

 

Total current liabilities

 

 

31,449

 

 

 

39,079

 

Operating lease liability, net of current portion

 

 

218

 

 

 

1,010

 

Deferred revenue, net of current portion

 

 

 

 

 

1,730

 

TOTAL LIABILITIES

 

 

31,667

 

 

 

41,819

 

SHAREHOLDERS’ EQUITY

 

 

 

 

 

 

Preferred shares, no par value per share; unlimited shares authorized
   as of June 30, 2024 and December 31, 2023, respectively;
0 shares issued
   and outstanding as of June 30, 2024, and December 31, 2023, respectively

 

 

 

 

 

 

Common shares, no par value per share; unlimited shares authorized as of
   June 30, 2024 and December 31, 2023;
42,445,533 and 42,176,041 shares
   issued and outstanding as of June 30, 2024 and December 31, 2023, respectively

 

 

486,375

 

 

 

483,350

 

Additional paid-in capital

 

 

72,157

 

 

 

61,813

 

Accumulated other comprehensive (loss) income

 

 

(134

)

 

 

28

 

Accumulated deficit

 

 

(354,721

)

 

 

(333,109

)

Total shareholders’ equity

 

 

203,677

 

 

 

212,082

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

 

$

235,344

 

 

$

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 Loss

(Unaudited)

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

 

 

 

Three Months Ended
June 30,

 

 

Six Months Ended
June 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

Collaboration agreements

 

$

1,073

 

 

$

30,249

 

 

$

53,477

 

 

$

35,927

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development, net of tax credits

 

 

30,075

 

 

 

33,788

 

 

 

63,045

 

 

 

65,618

 

General and administrative

 

 

8,317

 

 

 

8,719

 

 

 

16,935

 

 

 

17,248

 

Total operating expenses

 

 

38,392

 

 

 

42,507

 

 

 

79,980

 

 

 

82,866

 

Loss from operations

 

 

(37,319

)

 

 

(12,258

)

 

 

(26,503

)

 

 

(46,939

)

Other income (expense), net

 

 

 

 

 

 

 

 

 

 

 

 

Realized and unrealized gain (loss) on foreign exchange

 

 

6

 

 

 

(41

)

 

 

37

 

 

 

(97

)

Interest income

 

 

2,894

 

 

 

3,489

 

 

 

5,862

 

 

 

6,916

 

Other expense

 

 

(29

)

 

 

(26

)

 

 

(53

)

 

 

(41

)

Total other income, net

 

 

2,871

 

 

 

3,422

 

 

 

5,846

 

 

 

6,778

 

Loss before income taxes

 

 

(34,448

)

 

 

(8,836

)

 

 

(20,657

)

 

 

(40,161

)

Income tax expense

 

 

(326

)

 

 

(3,110

)

 

 

(955

)

 

 

(6,726

)

Net loss

 

$

(34,774

)

 

$

(11,946

)

 

$

(21,612

)

 

$

(46,887

)

Other comprehensive (loss) income:

 

 

 

 

 

 

 

 

 

 

 

 

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

 

$

(21

)

 

$

(189

)

 

$

(162

)

 

$

4

 

Total other comprehensive (loss) income

 

 

(21

)

 

 

(189

)

 

 

(162

)

 

 

4

 

Comprehensive loss

 

$

(34,795

)

 

$

(12,135

)

 

$

(21,774

)

 

$

(46,883

)

Net loss per share attributable to common shareholders - basic
   and diluted

 

$

(0.82

)

 

$

(0.28

)

 

$

(0.51

)

 

$

(1.11

)

Weighted-average common shares outstanding - basic and diluted

 

 

42,445,462

 

 

 

42,089,530

 

 

 

42,339,732

 

 

 

42,065,237

 

 

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

 

Share-based compensation
   expense

 

 

 

 

 

 

 

 

6,265

 

 

 

 

 

 

 

 

 

6,265

 

Exercise of stock options

 

 

14,050

 

 

 

62

 

 

 

(22

)

 

 

 

 

 

 

 

 

40

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

Share-based compensation
   expense

 

 

 

 

 

 

 

 

6,519

 

 

 

 

 

 

 

 

 

6,519

 

Exercise of stock options

 

 

127

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(21

)

 

 

 

 

 

(21

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(34,774

)

 

 

(34,774

)

Balance, June 30, 2024

 

 

42,445,533

 

 

$

486,375

 

 

$

72,157

 

 

$

(134

)

 

$

(354,721

)

 

$

203,677

 

 

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)

 

 

 

Six Months Ended
June 30,

 

 

 

2024

 

 

2023

 

Cash Flows From Operating Activities:

 

 

 

 

 

 

Net loss for the period

 

$

(21,612

)

 

$

(46,887

)

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

 

 

 

 

 

 

Share-based compensation expense

 

 

12,994

 

 

 

12,327

 

Depreciation expense

 

 

989

 

 

 

947

 

Non-cash lease expense

 

 

1,131

 

 

 

1,086

 

Foreign exchange (gain) loss

 

 

(27

)

 

 

60

 

Net accretion of marketable securities

 

 

(2,908

)

 

 

(3,928

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses

 

 

(1,024

)

 

 

1,518

 

Other current receivables

 

 

910

 

 

 

(988

)

Other non-current assets

 

 

89

 

 

 

89

 

Accounts payable

 

 

4,785

 

 

 

4,429

 

Accrued expenses and other current liabilities

 

 

(1,731

)

 

 

(17

)

Operating lease liability, current portion

 

 

(401

)

 

 

72

 

Income taxes

 

 

940

 

 

 

(2,991

)

Operating lease liability, net of current portion

 

 

(765

)

 

 

(1,172

)

Deferred revenue

 

 

(11,952

)

 

 

(30,677

)

Net cash used in operating activities

 

 

(18,582

)

 

 

(66,132

)

Cash Flows From Investing Activities:

 

 

 

 

 

 

Purchases of property and equipment

 

 

 

 

 

(1,540

)

Proceeds from maturities of marketable securities

 

 

89,015

 

 

 

169,000

 

Purchase of marketable securities

 

 

(102,213

)

 

 

(145,796

)

Net cash (used in) provided by investing activities

 

 

(13,198

)

 

 

21,664

 

Cash Flows From Financing Activities:

 

 

 

 

 

 

Proceeds from exercise of stock options

 

 

17

 

 

 

44

 

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

 

 

358

 

 

 

409

 

Net cash provided by financing activities

 

 

375

 

 

 

453

 

Effect of exchange rate fluctuations on cash held

 

 

(43

)

 

 

38

 

Net Decrease In Cash And Cash Equivalents

 

 

(31,448

)

 

 

(43,977

)

Cash and cash equivalents at beginning of period

 

 

111,268

 

 

 

159,521

 

Cash and cash equivalents at end of period

 

$

79,820

 

 

$

115,544

 

 

 

 

 

 

 

Supplemental Disclosure Of Cash Flow Information:

 

 

 

 

 

 

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

 

$

 

 

$

149

 

 

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 June 30, 2024, the consolidated results of its operations for the three and six months ended June 30, 2024 and 2023, its statements of shareholders’ equity for the three and six months ended June 30, 2024 and 2023 and its consolidated cash flows for the six months ended June 30, 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 and six months ended June 30, 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.

Smaller Reporting Company

Repare qualifies as a “smaller reporting company” under the Exchange Act as of June 30, 2024 because the market value of its common shares held by non-affiliates was less than $200 million as of June 30, 2024. As a smaller reporting company, Repare may rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. For so long as the Company remains a smaller reporting company, it is permitted and intends to rely on such exemptions from certain disclosure and other requirements that are applicable to other public companies that are not smaller reporting companies.

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

7


 

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 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 December 15, 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 June 30, 2024

 

 

 

 

 

 

 

 

 

 

 

 

 Cash and cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

 Cash

 

$

44,565

 

 

$

 

 

$

 

 

$

44,565

 

 Money market funds

 

 

35,255

 

 

 

 

 

 

 

 

 

35,255

 

 Total cash and cash equivalents:

 

$

79,820

 

 

$

 

 

$

 

 

$

79,820

 

 Marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

 Commercial paper

 

$

109,240

 

 

$

5

 

 

$

(106

)

 

$

109,139

 

 Corporate debt securities

 

 

19,198

 

 

 

 

 

 

(34

)

 

 

19,164

 

 Total marketable securities

 

$

128,438

 

 

$

5

 

 

$

(140

)

 

$

128,303

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 June 30, 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 $103.5 million and $58.6 million that were in an immaterial, unrealized loss position as of June 30, 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 June 30, 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 six months ended June 30, 2024 and 2023.

8


 

The Company recognized a net unrealized loss of nil and $0.2 million in other comprehensive (loss) income in the three months ended June 30, 2024 and 2023, respectively, and a net unrealized loss of $0.2 million and nil in the six months ended June 30, 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 June 30, 2024 and December 31, 2023 are less than one year.

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 June 30, 2024

 

 

 

 

 

 

 

 

 

 

 

 

 Assets

 

 

 

 

 

 

 

 

 

 

 

 

 Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

 Money market funds

 

$

35,255

 

 

$

35,255

 

 

$

 

 

$

 

 Total cash equivalents

 

 

35,255

 

 

 

35,255

 

 

 

 

 

 

 

 Marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

 Commercial paper

 

 

109,139

 

 

 

 

 

 

109,139

 

 

 

 

 Corporate debt securities

 

 

19,164

 

 

 

 

 

 

19,164

 

 

 

 

 Total marketable securities

 

 

128,303

 

 

 

 

 

 

128,303

 

 

 

 

 Total financial assets

 

$

163,558

 

 

$

35,255

 

 

$

128,303

 

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 six months ended June 30, 2024, there were no transfers between fair value measure levels.

9


 

5. Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following:

 

 

As of
June 30,
2024

 

 

As of
December 31,
2023

 

 

 

(in thousands)

 

Accrued research and development expense

 

$

17,044

 

 

$

16,251

 

Accrued compensation and benefits

 

 

4,376

 

 

 

6,981

 

Accrued professional services

 

 

555

 

 

 

631

 

Other

 

 

335

 

 

 

194

 

Total accrued expenses and other current liabilities

 

$

22,310

 

 

$

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 Debio Collaboration Agreement 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 loss.

During the three and six months ended June 30, 2024, the Company recognized $0.9 million and $1.4 million, respectively, in net research and development costs with regards to the Debiopharm portion of the 50/50 cost sharing terms in the Debio Collaboration Agreement, and recorded a receivable from Debiopharm of $0.7 million as of June 30, 2024 in other current receivables.

7. Revenue recognition from Collaboration and License Agreements

The following table presents revenue from collaboration agreements:

 

 

Three Months Ended
June 30,

 

 

Six Months Ended
June 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 

 

(in thousands)

 

Roche Collaboration and License Agreement

 

$

1,073

 

 

$

4,825

 

 

$

50,888

 

 

$

10,137

 

Bristol-Myers Squibb Collaboration and License Agreement

 

 

 

 

 

14,951

 

 

 

2,589

 

 

 

15,317

 

Ono Collaboration Agreement

 

 

 

 

 

10,473

 

 

 

 

 

 

10,473

 

Total revenue

 

$

1,073

 

 

$

30,249

 

 

$

53,477

 

 

$

35,927

 

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

10


 

Agreement, the Company granted Roche a worldwide, perpetual, exclusive, sublicensable license to develop, manufacture, and 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 February 2024, the Company 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.

In March 2024, the Company received a further 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.

 

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

 

 

(50,888

)

Balance as of June 30, 2024

 

$

-

 

The Company recognized $1.1 million and $4.8 million for the three months ended June 30, 2024 and 2023, respectively, and $50.9 million and $10.1 million for the six months ended June 30, 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 recognition of all remaining deferred revenue for research and development services performed towards the completion of the Continuing Trials during the period.

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 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

11


 

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 June 30, 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.

Ono Collaboration Agreement

In January 2019, the Company entered into a research services, license and collaboration agreement, (the “Ono Agreement”), with Ono Pharmaceutical Company Ltd., or (“Ono”), pursuant to which the Company and Ono agreed to collaborate in the research of potential product candidates targeting Polθ and the development of the Company’s small molecule Polθ inhibitor program. In June 2023, the Company and Ono determined not to further extend the term of the Ono Agreement. As a result, no product candidate would be licensed to Ono pursuant to the terms of the Ono Agreement. The Company recognized approximately $10.5 million as revenue for the three and six months ended June 30, 2023 with regards to the performance obligation under the Ono Agreement. The Company did not recognize any revenue pursuant to the Ono Agreement during the three and six months ended June 30, 2024.

8. Leases

The Company has historically entered into lease arrangements for its facilities. As of June 30, 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
June 30,

 

 

Six Months Ended
June 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 

 

(in thousands)

 

Operating Leases - Lease Costs