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Repare Therapeutics Provides Business Update and Reports Second Quarter 2023 Financial Results

Presented initial camonsertib-PARPi combination Phase 1/2 clinical data at AACR 2023 demonstrating durable clinical benefit across tumor types, genomic alterations, PARPi choice or platinum resistance

Roche has included a camonsertib-based arm in its Phase 2 TAPISTRY study and its Phase 1/2 Morpheus Lung study of multiple combinations in metastatic non-small cell lung cancer

Reported clinical proof of concept for lunresertib (RP-6306) in June 2023 including achievement of monotherapy safety and tolerability primary endpoints and identification of two proposed dose/schedules

Presented early lunresertib combination response data in June 2023, and expects to present further Phase 1 MYTHIC Module 2 data at a medical conference in the fourth quarter of this year

Granted FDA Fast Track designation for lunresertib in combination with camonsertib for the treatment of adult patients with CCNE1 amplified, or FBXW7 or PPP2R1A mutated endometrial cancer in August

Initiated IND-enabling studies for newly designated Polθ inhibitor RP-3467

CAMBRIDGE, Mass. & MONTREAL–(BUSINESS WIRE)–Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today reported financial results for the second quarter ended June 30, 2023.

“During the second quarter we made great progress advancing our clinical programs and presenting novel findings from our ongoing clinical trials, including reporting on camonsertib’s combination with three PARP inhibitors and initial clinical proof of concept for lunresertib,” said Lloyd M. Segal, President and Chief Executive Officer of Repare. “While these clinical programs move towards Phase 2 studies, we continue to support our preclinical pipeline, for example with the designation of our Polθ inhibitor, RP-3467. We look forward to reporting initial combination data of lunresertib with camonsertib in the fourth quarter of this year as we continue advancing our differentiated, synthetic lethal-based oncology pipeline.”

Second Quarter 2023 Review and Operational Updates:

Second Quarter 2023 Financial Results:

About Repare Therapeutics’ SNIPRx® Platform

Repare’s SNIPRx® platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company’s therapies based on the genetic profile of their tumors. Repare’s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx® screening, in order to selectively target those tumors in patients most likely to achieve clinical benefit from resulting product candidates.

About Repare Therapeutics, Inc.

Repare Therapeutics is a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s pipeline includes lunresertib (also known as RP-6306), a PKMYT1 inhibitor currently in Phase 1 clinical development; camonsertib (also known as RP-3500 or RG6526), a potential leading ATR inhibitor currently in Phase 1/2 clinical development and partnered with Roche; RP-3467, a preclinical Polθ inhibitor program; as well as several additional, undisclosed preclinical programs, including RP-1664. For more information, please visit reparerx.com.

SNIPRx® is a registered trademark of Repare Therapeutics Inc.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and securities laws in Canada. All statements in this press release other than statements of historical facts are “forward-looking statements. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the safety, efficacy and clinical progress of the Company’s clinical programs, including lunresertib (RP-6306) and camonsertib; the clinical and preclinical development of the Company’s pipeline and its research and development programs, including the anticipated timing, anticipated patient enrollment, trial outcomes or associated costs of its clinical trials of lunresertib and camonsertib; and the status of clinical trials (including, without limitation, expectations regarding the data that is being presented, the expected timing of data releases and development, as well as completion of clinical trials) and development timelines for the Company’s product candidates. These forward-looking statements are based on the Company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause the Company’s clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Many factors may cause differences between current expectations and actual results, including: the impacts of macroeconomic conditions, including the COVID-19 pandemic, the conflict in Ukraine, rising inflation, and uncertain credit and financial markets on the Company’s business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; and unexpected litigation or other disputes. Other factors that may cause the Company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are identified in the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the Securities and Exchange Commission (“SEC”) and the Québec Autorité des Marchés Financiers (“AMF”) on February 28, 2023, and its other documents subsequently filed with or furnished to the SEC and AMF. The Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. For more information, please visit reparerx.com and follow Repare on Twitter at @RepareRx and on LinkedIn at https://www.linkedin.com/company/repare-therapeutics/.

 

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,

 

 

 

2023

 

 

2022

 

ASSETS

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

 

Cash and cash equivalents

 

$

115,544

 

 

$

159,521

 

Marketable securities

 

 

165,148

 

 

 

184,420

 

Income tax receivable

 

 

1,751

 

 

 

 

Other current receivables

 

 

5,281

 

 

 

4,323

 

Prepaid expenses

 

 

4,201

 

 

 

5,715

 

Total current assets

 

 

291,925

 

 

 

353,979

 

Property and equipment, net

 

 

4,821

 

 

 

4,228

 

Operating lease right-of-use assets

 

 

4,434

 

 

 

5,371

 

Other assets

 

 

408

 

 

 

497

 

TOTAL ASSETS

 

$

301,588

 

 

$

364,075

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

 

Accounts payable

 

$

4,893

 

 

$

461

 

Accrued expenses and other current liabilities

 

 

21,628

 

 

 

21,645

 

Operating lease liability, current portion

 

 

2,320

 

 

 

2,171

 

Deferred revenue, current portion

 

 

24,412

 

 

 

53,102

 

Income tax payable

 

 

 

 

 

1,240

 

Total current liabilities

 

 

53,253

 

 

 

78,619

 

Operating lease liability, net of current portion

 

 

2,226

 

 

 

3,257

 

Deferred revenue, net of current portion

 

 

695

 

 

 

2,682

 

TOTAL LIABILITIES

 

 

56,174

 

 

 

84,558

 

SHAREHOLDERS’ EQUITY

 

 

 

 

 

 

Preferred shares, no par value per share; unlimited shares authorized

as of June 30, 2023 and December 31, 2022, respectively; 0 shares issued

and outstanding as of June 30, 2023, and December 31, 2022, respectively

 

 

 

 

 

 

Common shares, no par value per share; unlimited shares authorized as of

June 30, 2023 and December 31, 2022; 42,093,946 and 42,036,193 shares

issued and outstanding as of June 30, 2023 and December 31, 2022, respectively

 

 

482,739

 

 

 

482,032

 

Additional paid-in capital

 

 

49,299

 

 

 

37,226

 

Accumulated other comprehensive loss

 

 

(424

)

 

 

(428

)

Accumulated deficit

 

 

(286,200

)

 

 

(239,313

)

Total shareholders’ equity

 

 

245,414

 

 

 

279,517

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

 

$

301,588

 

 

$

364,075

 

 

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,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

Collaboration agreements

 

$

30,249

 

 

$

679

 

 

$

35,927

 

 

$

1,087

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development, net of tax credits

 

 

33,788

 

 

 

31,475

 

 

 

65,618

 

 

 

57,933

 

General and administrative

 

 

8,719

 

 

 

7,938

 

 

 

17,248

 

 

 

16,717

 

Total operating expenses

 

 

42,507

 

 

 

39,413

 

 

 

82,866

 

 

 

74,650

 

Loss from operations

 

 

(12,258

)

 

 

(38,734

)

 

 

(46,939

)

 

 

(73,563

)

Other income (expense), net

 

 

 

 

 

 

 

 

 

 

 

 

Realized and unrealized (loss) gain on foreign exchange

 

 

(41

)

 

 

141

 

 

 

(97

)

 

 

124

 

Interest income

 

 

3,489

 

 

 

544

 

 

 

6,916

 

 

 

673

 

Other expense

 

 

(26

)

 

 

(11

)

 

 

(41

)

 

 

(19

)

Total other income, net

 

 

3,422

 

 

 

674

 

 

 

6,778

 

 

 

778

 

Loss before income taxes

 

 

(8,836

)

 

 

(38,060

)

 

 

(40,161

)

 

 

(72,785

)

Income tax expense

 

 

(3,110

)

 

 

(33

)

 

 

(6,726

)

 

 

(65

)

Net loss

 

$

(11,946

)

 

$

(38,093

)

 

$

(46,887

)

 

$

(72,850

)

Other comprehensive (loss) gain:

 

 

 

 

 

 

 

 

 

 

 

 

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

securities

 

$

(189

)

 

$

 

 

$

4

 

 

$

 

Total other comprehensive (loss) gain

 

 

(189

)

 

 

 

 

 

4

 

 

 

 

Comprehensive loss

 

$

(12,135

)

 

$

(38,093

)

 

$

(46,883

)

 

$

(72,850

)

Net loss per share attributable to common shareholders – basic and

diluted

 

$

(0.28

)

 

$

(0.91

)

 

$

(1.11

)

 

$

(1.74

)

Weighted-average common shares outstanding – basic and diluted

 

 

42,089,530

 

 

 

41,899,509

 

 

 

42,065,237

 

 

 

41,880,666

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contacts

Repare Contact:
Steve Forte

Executive Vice-President and Chief Financial Officer

Repare Therapeutics Inc.

investor@reparerx.com

Investors:
Matthew DeYoung

Argot Partners

repare@argotpartners.com

Media:
David Rosen

Argot Partners

david.rosen@argotpartners.com
212-600-1902

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