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 August 4, 2022, Repare Therapeutics Inc. (the “Company”) issued a press release announcing its recent business highlights and financial results for the three and six months ended June 30, 2022. 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 thereunto duly authorized.
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REPARE THERAPEUTICS INC. |
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Date: |
August 4, 2022 |
By: |
/s/ Lloyd M. Segal |
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Lloyd M. Segal |
Repare Therapeutics Provides Business Update and Reports Second Quarter 2022 Financial Results
Signed worldwide license and collaboration agreement with Roche for the development and commercialization of camonsertib (also known as RP-3500)
Repare received a $125 million upfront payment in July 2022 as part of the collaboration agreement with Roche, and is eligible to receive up to an additional $1.172 billion in potential development, regulatory, commercial and sales milestones, plus royalties on global net product sales
Early Phase 1 clinical data readout for RP-6306 is now expected in the first half of 2023 for monotherapy and potentially for combination therapies
Initiated IND-enabling studies for the polymerase theta, or Polθ, inhibitor, now designated as RP-2119
CAMBRIDGE, Mass. & MONTREAL (BUSINESS WIRE)—August 4, 2022—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, 2022.
“The worldwide license and collaboration agreement we signed with Roche this quarter represents a major step in the broad global development and commercialization of camonsertib, and validates our strategy to build value into our pipeline by developing innovative drugs that target specific synthetic-lethal genomic alterations as we recently demonstrated at AACR,” said Lloyd M. Segal, President and Chief Executive Officer of Repare. “We have made substantial progress in our Phase 1 clinical trial evaluating RP-6306 as a monotherapy and in combination with camonsertib and two chemotherapy agents for the treatment of molecularly selected advanced solid tumors. We have also advanced our polymerase theta inhibitor, RP-2119, to IND-enabling studies. We look forward to providing an initial clinical data readout from the Phase 1 RP-6306 trial in the first half of 2023.”
Second Quarter 2022 Review and Operational Updates:
Second Quarter 2022 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 camonsertib (also known as RP-3500), a potential leading ATR inhibitor currently in Phase 1/2 clinical development partnered with Roche; RP-6306, a PKMYT1 inhibitor currently in Phase 1 clinical development; RP-2119, a Polθ inhibitor program in ongoing IND-enabling studies; as well as several additional, undisclosed preclinical programs. For more information, please visit reparerx.com.
SNIPRx® is a registered trademark of Repare Therapeutics Inc.
Forward-Looking Statement
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 clinical and preclinical development of the Company’s pipeline and its research and development programs, including the anticipated timing, anticipated patient enrollment or trial outcomes of its Phase 1 clinical trials of RP-6306 and its IND-enabling studies of RP-2119; the impact of COVID-19 pandemic on the trial site activation and patient enrollment in clinical trials; Repare’s collaboration with Roche, including the risk that Repare may not realize the potential benefits of this collaboration with Roche, potential milestone payments to be received under the collaboration and the discovery, development and potential commercialization of potential product candidates using Repare’s SNIPRx® platform technology under the collaboration agreement; and the Company’s anticipated cash runway guidance. 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 the COVID-19 pandemic 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 filed with the Securities and Exchange Commission (“SEC”) and the Québec Autorité des Marchés Financiers ("AMF") on May 5, 2022, and its other documents subsequently filed with or furnished to the SEC and AMF, including the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2022. 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.
Repare Therapeutics Inc.
Condensed 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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2022 |
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2021 |
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ASSETS |
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CURRENT ASSETS: |
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Cash and cash equivalents |
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$ |
275,834 |
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$ |
334,427 |
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Marketable securities |
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6,255 |
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7,439 |
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Research and development tax credits receivable |
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2,598 |
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2,580 |
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Income tax receivable |
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799 |
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— |
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Other receivables |
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1,010 |
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654 |
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Prepaid expenses |
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3,242 |
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6,314 |
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Total current assets |
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289,738 |
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351,414 |
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Property and equipment, net |
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5,124 |
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5,604 |
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Operating lease right-of-use assets |
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6,456 |
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7,491 |
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Other assets |
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497 |
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586 |
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Deferred tax assets |
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6,229 |
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3,620 |
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TOTAL ASSETS |
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$ |
308,044 |
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$ |
368,715 |
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LIABILITIES AND SHAREHOLDERS’ EQUITY |
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CURRENT LIABILITIES: |
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Accounts payable |
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$ |
4,991 |
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$ |
2,302 |
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Accrued expenses and other current liabilities |
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20,459 |
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18,622 |
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Operating lease liability, current portion |
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2,135 |
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1,721 |
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Deferred revenue, current portion |
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11,855 |
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11,921 |
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Income tax payable |
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— |
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523 |
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Total current liabilities |
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39,440 |
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35,089 |
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Operating lease liability, net of current portion |
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4,495 |
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5,592 |
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Deferred revenue, net of current portion |
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38,592 |
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39,613 |
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TOTAL LIABILITIES |
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82,527 |
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80,294 |
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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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481,380 |
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480,699 |
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Additional paid-in capital |
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27,253 |
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17,988 |
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Accumulated deficit |
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(283,116 |
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(210,266 |
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Total shareholders’ equity |
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225,517 |
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288,421 |
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TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
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$ |
308,044 |
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$ |
368,715 |
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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)
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Three Months Ended |
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Six Months Ended |
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2022 |
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2021 |
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2022 |
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2021 |
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Revenue: |
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Collaboration agreements |
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$ |
679 |
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$ |
279 |
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$ |
1,087 |
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$ |
445 |
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Operating expenses: |
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Research and development, net of tax credits |
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31,475 |
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20,205 |
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57,933 |
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36,714 |
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General and administrative |
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7,938 |
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6,741 |
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16,717 |
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11,978 |
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Total operating expenses |
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39,413 |
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26,946 |
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74,650 |
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48,692 |
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Loss from operations |
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(38,734 |
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(26,667 |
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(73,563 |
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(48,247 |
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Other income (expense), net |
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Realized and unrealized gain (loss) on foreign exchange |
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141 |
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(94 |
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124 |
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(125 |
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Interest income |
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544 |
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38 |
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673 |
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102 |
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Other expense |
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(11 |
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(7 |
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(19 |
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(14 |
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Total other income (expense), net |
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674 |
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(63 |
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778 |
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(37 |
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Loss before income taxes |
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(38,060 |
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(26,730 |
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(72,785 |
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(48,284 |
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Income tax recovery (expense) |
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(33 |
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421 |
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(65 |
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558 |
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Net loss and comprehensive loss |
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$ |
(38,093 |
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$ |
(26,309 |
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$ |
(72,850 |
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$ |
(47,726 |
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Net loss attributable to common shareholders—basic |
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$ |
(38,093 |
) |
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$ |
(26,309 |
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$ |
(72,850 |
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$ |
(47,726 |
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Net loss per share attributable to common |
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$ |
(0.91 |
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$ |
(0.71 |
) |
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$ |
(1.74 |
) |
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$ |
(1.29 |
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Weighted-average common shares outstanding—basic |
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41,899,509 |
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37,036,683 |
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41,880,666 |
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36,977,040 |
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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