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 6, 2024, 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, 2024. A copy of the press release is furnished hereto as Exhibit 99.1 and is incorporated herein by reference.
The information contained herein and in the accompanying exhibits 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.
The Company’s website and any information contained on the Company’s website are not incorporated into this Current Report on Form 8-K.
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: |
August 6, 2024 |
By: |
/s/ Lloyd M. Segal |
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Lloyd M. Segal |
Exhibit 99.1
Repare Therapeutics Provides Business and Clinical Update and Reports Second Quarter 2024 Financial Results
Reiterated guidance on data readout from MYTHIC trial evaluating lunresertib and camonsertib in patients with platinum-resistant ovarian and endometrial cancers in Q4 2024
Granted Fast Track designation by the FDA for lunresertib in combination with camonsertib in platinum-resistant ovarian cancer
Presented positive initial data from Phase 1 MINOTAUR clinical trial evaluating lunresertib in combination with FOLFIRI in heavily pretreated patients with gastrointestinal cancers at ESMO GI Congress 2024
Dosed first patient in camonsertib monotherapy NSCLC expansion of Phase 1/2 TRESR clinical trial
CAMBRIDGE, Mass. & MONTREAL (BUSINESS WIRE)—August 6, 2024— 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, 2024.
“We continued to make meaningful progress across our clinical programs in the second quarter and we look forward to a catalyst-rich second half of 2024 that includes the release of data from our ongoing MYTHIC dose expansion clinical trial evaluating the promising combination of lunresertib and camonsertib at the recommended Phase 2 dose. This combination therapy has the potential to be a new treatment paradigm in genomically-defined platinum-resistant ovarian cancer and second-line endometrial cancer. We remain on track to deliver this data in the fourth quarter of this year, with the potential to begin a registrational trial in 2025,” said Lloyd M. Segal, President and CEO of Repare. “As we prepare for potential near-term registrational clinical programs, we are thrilled that Dr. Steven H. Stein has joined Repare’s Board of Directors. He brings extensive experience in global pivotal trial development and will chair our Science and Technology Committee. He replaces Dr. Briggs Morrison, who has been instrumental in building Repare into a leading, precision oncology company. We are grateful for Dr. Morrison’s seven years of service, his substantial contributions to our company, and for his longstanding and ongoing support.”
Second Quarter 2024 and Recent Portfolio Highlights:
Second Quarter 2024 Financial Results:
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 1/2 clinical development; camonsertib (also known as RP-3500), a potential leading ATR inhibitor currently in Phase 1/2 clinical development; RP-1664, a Phase 1 PLK4 inhibitor; RP-3467, a preclinical Polθ ATPase inhibitor program; as well as additional, undisclosed preclinical programs. For more information, please visit www.reparerx.com and follow @Reparerx on X (formerly Twitter) and LinkedIn.
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 design, objectives, initiation, timing, progress and results of current and future preclinical studies and clinical trials of the Company’s product candidates, including the expansion of its Phase 2 MYTHIC trial evaluating lunresertib in combination with camonsertib in patients with platinum-resistant ovarian and endometrial cancers, its ongoing Phase 1 MINOTAUR trial evaluating lunresertib in combination with FOLFIRI, the expansion of its Phase 2 TRESR trial of camonsertib in patients with ATMm, its Phase 1 LIONS trial of RP-1664, its Phase 1 trial of RP-3467; a potential registrational trial in 2025; the tolerability, efficacy and clinical progress of camonsertib, lunresertib, RP-1664 and RP-3467; the potential of RP-3467 as a best-in-class Polθ ATPase inhibitor; the potential of lunresertib in combination with camonsertib as a new treatment platinum-resistant ovarian cancer and second-line endometrial cancer; the Company’s anticipated cash runway; and the benefits and ability to discover further targets and clinical candidates from the Company’s discovery platform. 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 potential that success in preclinical testing and earlier clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate; the impacts of macroeconomic conditions, including the conflict in Ukraine and the conflict in the Middle East, heightened 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; the Company’s ability to realize the benefits of its collaboration and license agreements; 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 June 30, 2024 filed with the Securities and Exchange Commission (“SEC”) and the Québec Autorité des Marchés Financiers ("AMF") on August 6, 2024. 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 X (formerly 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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2024 |
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2023 |
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ASSETS |
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CURRENT ASSETS: |
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Cash and cash equivalents |
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$ |
79,820 |
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$ |
111,268 |
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Marketable securities |
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128,303 |
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112,359 |
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Income tax receivable |
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11,072 |
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10,813 |
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Other current receivables |
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3,571 |
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4,499 |
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Prepaid expenses |
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5,773 |
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4,749 |
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Total current assets |
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228,539 |
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243,688 |
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Property and equipment, net |
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3,226 |
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4,215 |
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Operating lease right-of-use assets |
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2,195 |
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3,326 |
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Income tax receivable |
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1,077 |
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2,276 |
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Other assets |
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307 |
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396 |
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TOTAL ASSETS |
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$ |
235,344 |
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$ |
253,901 |
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LIABILITIES AND SHAREHOLDERS’ EQUITY |
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CURRENT LIABILITIES: |
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Accounts payable |
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$ |
7,182 |
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$ |
2,400 |
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Accrued expenses and other current liabilities |
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22,310 |
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24,057 |
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Operating lease liability, current portion |
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1,957 |
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2,400 |
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Deferred revenue, current portion |
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— |
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10,222 |
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Total current liabilities |
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31,449 |
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39,079 |
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Operating lease liability, net of current portion |
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218 |
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1,010 |
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Deferred revenue, net of current portion |
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— |
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1,730 |
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TOTAL LIABILITIES |
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31,667 |
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41,819 |
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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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486,375 |
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483,350 |
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Additional paid-in capital |
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72,157 |
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61,813 |
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Accumulated other comprehensive (loss) income |
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(134 |
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28 |
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Accumulated deficit |
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(354,721 |
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(333,109 |
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Total shareholders’ equity |
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203,677 |
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212,082 |
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TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
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$ |
235,344 |
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$ |
253,901 |
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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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Six Months Ended |
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2024 |
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2023 |
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2024 |
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2023 |
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Revenue: |
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Collaboration agreements |
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$ |
1,073 |
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$ |
30,249 |
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$ |
53,477 |
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$ |
35,927 |
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Operating expenses: |
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Research and development, net of tax credits |
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30,075 |
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33,788 |
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63,045 |
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65,618 |
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General and administrative |
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8,317 |
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8,719 |
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16,935 |
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17,248 |
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Total operating expenses |
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38,392 |
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42,507 |
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79,980 |
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82,866 |
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Loss from operations |
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(37,319 |
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(12,258 |
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(26,503 |
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(46,939 |
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Other income (expense), net |
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Realized and unrealized gain (loss) on foreign exchange |
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6 |
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(41 |
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37 |
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(97 |
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Interest income |
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2,894 |
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3,489 |
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5,862 |
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6,916 |
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Other expense |
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(29 |
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(26 |
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(53 |
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(41 |
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Total other income, net |
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2,871 |
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3,422 |
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5,846 |
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6,778 |
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Loss before income taxes |
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(34,448 |
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(8,836 |
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(20,657 |
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(40,161 |
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Income tax expense |
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(326 |
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(3,110 |
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(955 |
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(6,726 |
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Net loss |
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$ |
(34,774 |
) |
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$ |
(11,946 |
) |
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$ |
(21,612 |
) |
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$ |
(46,887 |
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Other comprehensive (loss) income: |
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Unrealized (loss) gain on available-for-sale marketable |
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$ |
(21 |
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$ |
(189 |
) |
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$ |
(162 |
) |
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$ |
4 |
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Total other comprehensive (loss) income |
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(21 |
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(189 |
) |
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(162 |
) |
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4 |
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Comprehensive loss |
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$ |
(34,795 |
) |
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$ |
(12,135 |
) |
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$ |
(21,774 |
) |
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$ |
(46,883 |
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Net loss per share attributable to common shareholders - basic |
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$ |
(0.82 |
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$ |
(0.28 |
) |
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$ |
(0.51 |
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$ |
(1.11 |
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Weighted-average common shares outstanding - basic and diluted |
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42,445,462 |
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42,089,530 |
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42,339,732 |
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42,065,237 |
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Investor Relations & Media Contact:
Robin Garner
Vice President and Head of Investor Relations
Repare Therapeutics Inc.