00-00000000001808158false00018081582022-05-052022-05-05

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 05, 2022

 

 

Repare Therapeutics Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Quebec			001-39335	Not applicable
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
7210 Frederick-Banting, Suite 100
St-Laurent, Quebec, Canada				H4S 2A1
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 857 412-7018

 

(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:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common shares, no par value		RPTX		The NASDAQ Stock Market LLC

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. ☐

 

 

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Item 2.02 Results of Operations and Financial Condition.

On May 5, 2022, Repare Therapeutics Inc. (the “Company”) issued a press release announcing its recent business highlights and financial results for the three months ended March 31, 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
No.		Description
99.1		Press Release dated May 5, 2022
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

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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.

			REPARE THERAPEUTICS INC.
Date:	May 5, 2022	By:	/s/ Lloyd M. Segal
			Lloyd M. Segal President and Chief Executive Officer

 

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Exhibit 99.1

 

Repare Therapeutics Provides Business Update and Reports First Quarter 2022 Financial Results

Oral presentation of clinical data from the Phase 1/2 TRESR Trial of camonsertib (also known as RP-3500) monotherapy in solid tumors at 2022 AACR Annual Meeting

Results demonstrated robust activity in ovarian cancer with a 75% CBR, 25% ORR and 35 weeks mPFS

Results also show 43% CBR in solid tumors across genotypes and tumor types, potential best-in-class safety and tolerability, and encouraging data in other genotypes beyond ATM

Publication of preclinical data in Nature demonstrated the potential of PKMYT1 inhibitor RP-6306 in tumors with CCNE1 amplification

Cambridge, MA & Montreal, QC, May 5, 2022 (BUSINESS WIRE)-- 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, 2022.

“The first quarter was marked by significant progress in our RP-3500 program, including the comprehensive new dataset from the TRESR trial which was part of the featured oral presentation at the AACR conference this year, and that the United States Adopted Names (USAN) council has adopted 'camonsertib' as the nonproprietary (generic) name in the United States, and the International Nonproprietary Names (INN) council has accepted 'camonsertib' as proposed INN for RP-3500," said Lloyd M. Segal, President and Chief Executive Officer of Repare. “The findings continue to demonstrate camonsertib’s promising clinical benefit given as monotherapy in patients with solid tumors with multiple genotypes and potential best-in-class safety and tolerability profile for ATR inhibitors. Beyond ATM, encouraging data in other genotypes suggest further validation of our STEP2 platform to identify other synthetic lethalities as we expand TRESR and develop our pipeline of synthetic lethal candidates. We look forward to providing updates on the potential of camonsertib as monotherapy and initial data of camonsertib in combination with PARP inhibitors or gemcitabine expected in the second half of this year.”

First Quarter 2022 Review and Operational Updates:

 

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First 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

 

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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 its lead product candidate camonsertib (also known as RP-3500), a potential leading ATR inhibitor currently in Phase 1/2 clinical development, its second clinical candidate, RP-6306, a PKMYT1 inhibitor currently in Phase 1 clinical development, a Polθ inhibitor program, as well as several early-stage, pre-clinical 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. 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 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 1/2 TRESR clinical trial of camonsertib (also known as RP-3500). 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 Annual Report on Form 10-K for the year ended December 31, 2021 filed with the Securities and Exchange Commission (“SEC”) and the Québec Autorité des Marchés Financiers ("AMF") on March 1, 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 March 31, 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.

 

 

 

 

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Repare Therapeutics Inc.

Consolidated Balance Sheets

(Unaudited)

(Amounts in thousands of U.S. dollars, except share data)

 

		As of March 31,				As of December 31,
		2022				2021
ASSETS
CURRENT ASSETS:
Cash and cash equivalents		$	305,136			$	334,427
Marketable securities			6,528				7,439
Research and development tax credits receivable			2,986				2,580
Other receivables			663				654
Prepaid expenses			3,915				6,314
Total current assets			319,228				351,414
Property and equipment, net			5,397				5,604
Operating lease right-of-use assets			7,003				7,491
Other assets			586				586
Deferred tax assets			4,935				3,620
TOTAL ASSETS		$	337,149			$	368,715
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable		$	1,546			$	2,302
Accrued expenses and other current liabilities			16,936				18,622
Operating lease liability, current portion			1,857				1,721
Deferred revenue, current portion			11,874				11,921
Income tax payable			1,870				523
Total current liabilities			34,083				35,089
Operating lease liability, net of current portion			5,154				5,592
Deferred revenue, net of current portion			39,252				39,613
TOTAL LIABILITIES			78,489				80,294
SHAREHOLDERS’ EQUITY
Preferred shares, no par value per share; unlimited shares authorized    as of March 31, 2022 and December 31, 2021, respectively; 0 shares issued    and outstanding as of March 31, 2022, and December 31, 2021, respectively			—				—
Common shares, no par value per share; unlimited shares authorized as of    March 31, 2022 and December 31, 2021; 41,879,204 and 41,850,162 shares    issued and outstanding as of March 31, 2022 and December 31, 2021, respectively			481,048				480,699
Additional paid-in capital			22,635				17,988
Accumulated deficit			(245,023	)			(210,266	)
Total shareholders’ equity			258,660				288,421
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY		$	337,149			$	368,715

 

 

 

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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)

 

		Three Months Ended March 31,
		2022				2021
Revenue:
Collaboration agreements		$	408			$	166
Operating expenses:
Research and development, net of tax credits			26,458				16,509
General and administrative			8,779				5,237
Total operating expenses			35,237				21,746
Loss from operations			(34,829	)			(21,580	)
Other income (expense), net
Realized and unrealized loss on foreign exchange			(17	)			(31	)
Interest income			129				64
Other expense			(8	)			(7	)
Total other income (expense), net			104				26
Loss before income taxes			(34,725	)			(21,554	)
Income tax recovery (expense)			(32	)			137
Net loss and comprehensive loss		$	(34,757	)		$	(21,417	)
Net loss attributable to common shareholders—basic    and diluted		$	(34,757	)		$	(21,417	)
Net loss per share attributable to common    shareholders—basic and diluted		$	(0.83	)		$	(0.58	)
Weighted-average common shares outstanding—basic   and diluted			41,861,613				36,916,734

 

 

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Repare Contact:

Steve Forte

Chief Financial Officer

Repare Therapeutics Inc.

[email protected]

Investors:

Kimberly Minarovich
Argot Partners

[email protected]

Media:

David Rosen

Argot Partners

[email protected]

212-600-1902

 

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