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
Date of Report (Date of earliest event reported): |
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: |
|
(Former Name or Former Address, if Changed Since Last Report)
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:
|
|
Trading |
|
|
|
|
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 February 28, 2024, Repare Therapeutics Inc. (the "Company") issued a press release announcing its recent business highlights and financial results for the three and twelve months ended December 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 |
|
|
No. |
|
Description |
99.1 |
|
|
104 |
|
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.
|
|
|
REPARE THERAPEUTICS INC. |
|
|
|
|
Date: |
February 28, 2024 |
By: |
/s/ Lloyd M. Segal |
|
|
|
Lloyd M. Segal |
Exhibit 99.1
Repare Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results
CAMBRIDGE, Mass. & MONTREAL (BUSINESS WIRE)—February 28, 2024— Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today reported financial results for the fourth quarter and full year ended December 31, 2023.
“2023 was a year of substantial progress for Repare. We advanced each of the four programs in our portfolio and set the stage for meaningful data readouts and new clinical trial starts this year,” said Lloyd M. Segal, President and Chief Executive Officer of Repare. “In particular and as leaders and innovators in PKMYT1 inhibition, we look forward to data readouts across all ongoing lunresertib clinical trials in 2024 and are excited to begin a lunresertib and WEE1 combination clinical trial in partnership with Debiopharm.”
2023 and Recent Portfolio Highlights:
2024 Outlook:
Fourth Quarter and Full Year 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 1/2 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 its Phase 1 MYTHIC trial evaluating lunresertib alone and in combination with camonsertib, its MINOTAUR trial evaluating lunresertib in combination with FOLFIRI, its MAGNETIC trial evaluating lunresertib in combination with gemcitabine, its Phase 1/1b trial of Debio 0123 and lunresertib in partnership with Debiopharm, its Phase 1 trial of RP-1664, its Phase 1 trial of RP-3467, and its additional clinical development plans for camonsertib beyond the TRESR and ATTACC clinical trials; 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 synergy of Debio 0123 and lunresertib and potential benefits of the collaboration; 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 Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission (“SEC”) and the Québec Autorité des Marchés Financiers ("AMF") on February 28, 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 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)
|
|
As of December 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
ASSETS |
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
111,268 |
|
|
$ |
159,521 |
|
Marketable securities |
|
|
112,359 |
|
|
|
184,420 |
|
Income tax receivable |
|
|
10,813 |
|
|
|
— |
|
Other current receivables |
|
|
4,499 |
|
|
|
4,323 |
|
Prepaid expenses |
|
|
4,749 |
|
|
|
5,715 |
|
Total current assets |
|
|
243,688 |
|
|
|
353,979 |
|
Property and equipment, net |
|
|
4,215 |
|
|
|
4,228 |
|
Operating lease right-of-use assets |
|
|
3,326 |
|
|
|
5,371 |
|
Income tax receivable |
|
|
2,276 |
|
|
|
— |
|
Other assets |
|
|
396 |
|
|
|
497 |
|
TOTAL ASSETS |
|
$ |
253,901 |
|
|
$ |
364,075 |
|
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
2,400 |
|
|
$ |
461 |
|
Accrued expenses and other current liabilities |
|
|
24,057 |
|
|
|
21,645 |
|
Operating lease liabilities, current portion |
|
|
2,400 |
|
|
|
2,171 |
|
Deferred revenue, current portion |
|
|
10,222 |
|
|
|
53,102 |
|
Income tax payable |
|
|
— |
|
|
|
1,240 |
|
Total current liabilities |
|
|
39,079 |
|
|
|
78,619 |
|
Operating lease liabilities, net of current portion |
|
|
1,010 |
|
|
|
3,257 |
|
Deferred revenue, net of current portion |
|
|
1,730 |
|
|
|
2,682 |
|
TOTAL LIABILITIES |
|
|
41,819 |
|
|
|
84,558 |
|
Commitments and Contingencies |
|
|
|
|
|
|
||
SHAREHOLDERS’ EQUITY: |
|
|
|
|
|
|
||
Preferred shares, no par value per share; unlimited shares authorized as |
|
|
— |
|
|
|
— |
|
Common shares, no par value per share; unlimited shares authorized as |
|
|
483,350 |
|
|
|
482,032 |
|
Additional paid-in capital |
|
|
61,813 |
|
|
|
37,226 |
|
Accumulated other comprehensive loss |
|
|
28 |
|
|
|
(428 |
) |
Accumulated deficit |
|
|
(333,109 |
) |
|
|
(239,313 |
) |
TOTAL SHAREHOLDERS’ EQUITY |
|
|
212,082 |
|
|
|
279,517 |
|
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
$ |
253,901 |
|
|
$ |
364,075 |
|
Repare Therapeutics Inc.
Consolidated Statements of Operations
(Unaudited)
(Amounts in thousands of U.S. dollars, except share and per share data)
|
|
Year Ended |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
Revenue: |
|
|
|
|
|
|
||
Collaboration agreements |
|
$ |
51,133 |
|
|
$ |
131,830 |
|
Operating expenses: |
|
|
|
|
|
|
||
Research and development, net of tax credits |
|
|
133,593 |
|
|
|
119,066 |
|
General and administrative |
|
|
33,764 |
|
|
|
32,560 |
|
Total operating expenses |
|
|
167,357 |
|
|
|
151,626 |
|
Loss from operations |
|
|
(116,224 |
) |
|
|
(19,796 |
) |
Other income (expense), net |
|
|
|
|
|
|
||
Realized and unrealized (loss) gain on foreign exchange |
|
|
(170 |
) |
|
|
308 |
|
Interest income |
|
|
13,334 |
|
|
|
5,631 |
|
Other expense, net |
|
|
(119 |
) |
|
|
(43 |
) |
Total other income, net |
|
|
13,045 |
|
|
|
5,896 |
|
Loss before income taxes |
|
|
(103,179 |
) |
|
|
(13,900 |
) |
Income tax benefit (expense) |
|
|
9,383 |
|
|
|
(15,147 |
) |
Net loss |
|
$ |
(93,796 |
) |
|
$ |
(29,047 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
||
Unrealized gain (loss) on available-for-sale marketable securities |
|
|
456 |
|
|
|
(428 |
) |
Total other comprehensive income (loss) |
|
$ |
456 |
|
|
$ |
(428 |
) |
Comprehensive loss |
|
$ |
(93,340 |
) |
|
$ |
(29,475 |
) |
Net loss per share attributable to common shareholders—basic and diluted |
|
$ |
(2.23 |
) |
|
$ |
(0.69 |
) |
Weighted-average common shares outstanding—basic and diluted |
|
|
42,093,293 |
|
|
|
41,922,042 |
|
|
|
Three Months Ended |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
Key financial highlights: |
|
|
|
|
|
|
||
Revenues from collaboration agreements |
|
$ |
13,047 |
|
|
$ |
18,198 |
|
Research and development, net of tax credits |
|
$ |
35,266 |
|
|
$ |
29,891 |
|
General and administrative |
|
$ |
8,648 |
|
|
$ |
7,939 |
|
Net loss |
|
$ |
(28,030 |
) |
|
$ |
(31,658 |
) |
Net loss per share attributable to common shareholders—basic and diluted |
|
$ |
(0.67 |
) |
|
$ |
(0.75 |
) |
Weighted-average common shares outstanding—basic and diluted |
|
|
42,139,096 |
|
|
|
41,979,869 |
|
Repare Contact:
Robin Garner
Vice President and Head of Investor Relations
Repare Therapeutics Inc.
Investors:
Matthew DeYoung
Argot Partners
Media:
David Rosen
Argot Partners
212-600-1902