UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
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. ☐
Item 2.02 Results of Operations and Financial Condition.
On May 9, 2023, Repare Therapeutics Inc. (the "Company") issued a press release announcing its recent business highlights and financial results for the three months ended March 31, 2023. A copy of the press release is furnished hereto as Exhibit 99.1 and is incorporated herein by reference.
The information in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section. The information contained herein and in the accompanying exhibit is not incorporated by reference in any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
Exhibit |
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No. |
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Description |
99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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REPARE THERAPEUTICS INC. |
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Date: |
May 9, 2023 |
By: |
/s/ Lloyd M. Segal |
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Lloyd M. Segal |
Exhibit 99.1
Repare Therapeutics Provides Business Update and Reports First Quarter 2023 Financial Results
Reported initial camonsertib data from ongoing Phase 1/2 TRESR and Phase 1b/2 ATTACC clinical trials in a plenary oral presentation at 2023 AACR Annual Meeting
Camonsertib combination therapy showed 48% CBR across tumor types regardless of choice of PARP inhibitor or platinum resistance, with a favorable safety and tolerability profile
Company on track to report initial RP-6306 monotherapy data from Phase 1 MYTHIC clinical trial in June 2023
Announced the appointment of Susan Molineaux, Ph.D., and departure of Jerel Davis, Ph.D. on our Board of Directors, as well as the addition of Daniel Belanger to the senior leadership team
CAMBRIDGE, Mass. & MONTREAL (BUSINESS WIRE)—May 9, 2023— Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today reported financial results for the first quarter ended March 31, 2023.
“We continue to execute clinically and across our pipeline programs, including presenting initial clinical data of camonsertib in combination with various PARP inhibitors from the ongoing TRESR and ATTACC trials at this year’s AACR conference,” said Lloyd M. Segal, President and Chief Executive Officer of Repare. “These findings are consistent with our preclinical data demonstrating that low, intermittent dosing of the camonsertib and PARP inhibitor combinations appears well tolerated and exhibited antitumor activity, most notably in advanced ovarian cancer. In addition, we are on track to present initial Phase 1 monotherapy data for RP-6306 in June.”
First Quarter 2023 Review and Operational Updates:
First 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 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; a preclinical Polθ inhibitor program; as well as several 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 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 RP-6306 and camonsertib and ongoing preclinical studies and future clinical trials of the Company's RP-1664 and Polθ inhibitor programs; the Company’s continued development of camonsertib in partnership with Roche; 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 the completion of clinical trials) and development timelines for the Company’s product candidates; ; and the expected benefits of the Company’s collaborations and partnerships. 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 evolving impact of macroeconomic events, including the COVID-19 pandemic, rising inflation, the U.S. Federal Reserve raising interest rates, recent disruptions in access to bank deposits or lending commitments due to bank failures and the Russia-Ukraine war, 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.
Consolidated Balance Sheets
(Unaudited)
(Amounts in thousands of U.S. dollars, except share data)
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As of |
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As of |
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2023 |
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2022 |
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ASSETS |
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CURRENT ASSETS: |
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Cash and cash equivalents |
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$ |
121,461 |
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$ |
159,521 |
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Marketable securities |
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192,663 |
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184,420 |
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Research and development tax credits receivable |
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1,659 |
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1,280 |
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Collaboration revenue receivable |
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3,996 |
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1,525 |
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Other receivables |
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1,358 |
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1,518 |
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Prepaid expenses |
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4,389 |
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5,715 |
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Total current assets |
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325,526 |
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353,979 |
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Property and equipment, net |
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5,396 |
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4,228 |
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Operating lease right-of-use assets |
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4,976 |
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5,371 |
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Other assets |
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408 |
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497 |
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TOTAL ASSETS |
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$ |
336,306 |
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$ |
364,075 |
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LIABILITIES AND SHAREHOLDERS’ EQUITY |
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CURRENT LIABILITIES: |
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Accounts payable |
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$ |
3,620 |
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$ |
461 |
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Accrued expenses and other current liabilities |
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17,442 |
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21,645 |
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Operating lease liability, current portion |
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2,257 |
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2,171 |
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Deferred revenue, current portion |
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52,760 |
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53,102 |
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Income tax payable |
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4,856 |
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1,240 |
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Total current liabilities |
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80,935 |
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78,619 |
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Operating lease liability, net of current portion |
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2,780 |
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3,257 |
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Deferred revenue, net of current portion |
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1,347 |
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2,682 |
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TOTAL LIABILITIES |
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85,062 |
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84,558 |
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SHAREHOLDERS’ EQUITY |
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Preferred shares, no par value per share; unlimited shares authorized |
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— |
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— |
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Common shares, no par value per share; unlimited shares authorized as of |
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482,677 |
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482,032 |
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Additional paid-in capital |
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43,056 |
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37,226 |
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Accumulated other comprehensive loss |
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(235 |
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(428 |
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Accumulated deficit |
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(274,254 |
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(239,313 |
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Total shareholders’ equity |
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251,244 |
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279,517 |
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TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
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$ |
336,306 |
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$ |
364,075 |
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Repare Therapeutics Inc.
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(Amounts in thousands of U.S. dollars, except share and per share data)
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Three Months Ended |
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2023 |
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2022 |
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Revenue: |
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Collaboration agreements |
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$ |
5,678 |
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$ |
408 |
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Operating expenses: |
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Research and development, net of tax credits |
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31,830 |
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26,458 |
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General and administrative |
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8,529 |
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8,779 |
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Total operating expenses |
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40,359 |
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35,237 |
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Loss from operations |
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(34,681 |
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(34,829 |
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Other income (expense), net |
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Realized and unrealized loss on foreign exchange |
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(56 |
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(17 |
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Interest income |
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3,427 |
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129 |
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Other expense |
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(15 |
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(8 |
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Total other income, net |
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3,356 |
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104 |
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Loss before income taxes |
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(31,325 |
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(34,725 |
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Income tax expense |
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(3,616 |
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(32 |
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Net loss |
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$ |
(34,941 |
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$ |
(34,757 |
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Other comprehensive gain: |
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Unrealized gain on available-for-sale marketable securities |
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$ |
193 |
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$ |
— |
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Total other comprehensive gain |
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193 |
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— |
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Comprehensive loss |
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$ |
(34,748 |
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$ |
(34,757 |
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Net loss per share attributable to common shareholders - basic and diluted |
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$ |
(0.83 |
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$ |
(0.83 |
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Weighted-average common shares outstanding - basic and diluted |
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42,040,674 |
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41,861,613 |
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Repare Contact:
Robin Garner
Executive Director and Head of Investor Relations
Repare Therapeutics Inc.
Investors:
Matthew DeYoung
Argot Partners
Media:
David Rosen
Argot Partners
212-600-1902