Repare Therapeutics Provides Business Update and Reports First Quarter 2021 Financial Results

May 13, 2021

Introduced PKMYT1 as synthetic-lethal target for tumors with CCNE1 amplification or FBXW7 loss and highlighted program progress at RP-6306 Virtual Investor Day Event

Announced enrollment of first patient in RP-6306 Phase 1 clinical trial

Activated 10 clinical trial sites across North America and Europe for the PARP-inhibitor combination arm of the RP-3500 TRESR Phase 1/2 clinical trial

CAMBRIDGE, Mass. & MONTREAL--(BUSINESS WIRE)--May 13, 2021-- Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics, today reported financial results for the first quarter ended March 31, 2021.

“We have advanced the Phase 1/2 clinical development of our ATR inhibitor RP-3500, with initial results expected from the monotherapy arm of the trial in the second half of 2021. The PARP inhibitor and RP-3500 combination arm is now recruiting,” said Lloyd M. Segal, President and Chief Executive Officer of Repare. “We are pleased that the first patient has been dosed in our Phase 1 clinical trial of RP-6306, materially ahead of the timeline we disclosed at the time of our IPO last June.”

First Quarter 2021 Review and Operational Updates:

  • Highlighted program progress and introduced PKMYT1 as synthetic-lethal target to CCNE1 and FBXW7 at RP-6306 Virtual Investor Day Event.
    • In April 2021, the Company highlighted pre-clinical anti-tumor activity of RP-6306, a potential first-in-class small molecule product candidate targeting PKMYT1, which is synthetic lethal with CCNE1 amplification, FBXW7 loss, and potentially other genomic alterations.
  • Announced enrollment of first patient in RP-6306 Phase 1 clinical trial.
    • In April 2021, the Company dosed the first patient in its Phase 1 clinical trial of RP-6306.
    • The trial (NCT04855656) is expected to enroll approximately 60 patients with recurrent tumors characterized by genomic alterations predicted by the Company’s SNIPRx® CRISPR-based platform to be sensitive to RP-6306.
    • The trial objectives include assessment of safety, tolerability, dose and schedule (including the establishment of a recommended Phase 2 dose).
    • Subject to completion and review of the Phase 1 clinical trial, the Company expects to advance RP-6306, both as monotherapy and in combination with chemotherapies and other agents, into proof-of-concept trials in 2022 targeting a variety of patient populations, including those with tumors with CCNE1 amplification, FBXW7 loss or other undisclosed alterations identified through its proprietary STEP2 screen.
    • Prospective enrichment of patient trial populations will be guided by the Company’s ongoing efforts to develop patient selection, target engagement and functional biomarkers.
  • Initiated patient recruitment of PARP-inhibitor combination arm of the RP-3500 TRESR Phase 1/2 clinical trial.
    • Repare has activated 10 clinical trial sites across North America and Europe, and is actively recruiting patients to evaluate RP-3500 in a combination arm with Pfizer’s PARP inhibitor, talazoparib, in addition to a monotherapy arm.
    • Initial results are expected to be reported from the monotherapy arm of the trial in the second half of 2021.

First Quarter 2021 Financial Results:

  • Cash and cash equivalents, restricted cash and marketable securities: Cash and cash equivalents, restricted cash and marketable securities as of March 31, 2021 were $319.1 million.
  • Research and development expenses, net of tax credits (Net R&D): Net R&D expenses were $16.5 million and $8.6 million for the quarters ended March 31, 2021 and 2020, respectively. The increase in R&D expenses year-over-year was primarily due to increases in development costs related to the Company’s RP-3500 and RP-6306 programs, as well as increases in personnel related expenses, including stock-based compensation, and certain other R&D expenses.
  • General and administrative (G&A) expenses: G&A expenses were $5.2 million and $2.2 million for the quarters ended March 31, 2021 and 2020, respectively. The increase in G&A expenses year-over-year was due to increases in personnel related costs, including stock-based compensation, and D&O insurance which increased as a result of the Company’s transition to a public company.
  • Net loss: Net loss was $21.4 million, or $0.58 per share in the quarter ended March 31, 2021 and $12.6 million, or $7.71 per share, in the quarter ended March 31, 2020.

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 its lead product candidate 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 eight other 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, trial outcomes or associated costs of its clinical trials of RP-3500 and RP-6306; and the Company’s ability to advance RP-6306, both as monotherapy and in combination with chemotherapies and other agents, into proof-of-concept trials in 2022. 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, 2020 filed with the Securities and Exchange Commission (“SEC”) on March 4, 2021. 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)

 

 

 

As of
March 31,

 

 

As of
December 31,

 

 

 

2021

 

 

2020

 

ASSETS

 

 

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

311,399

 

 

$

326,184

 

Marketable securities

 

 

7,497

 

 

 

7,526

 

Research and development tax credits receivable

 

 

2,263

 

 

 

2,011

 

Other receivables

 

 

3,169

 

 

 

4,153

 

Prepaid expenses

 

 

3,882

 

 

 

6,678

 

Total current assets

 

 

328,210

 

 

 

346,552

 

Property and equipment, net

 

 

4,466

 

 

 

3,948

 

Restricted cash

 

 

215

 

 

 

212

 

Operating lease right-of-use assets

 

 

4,303

 

 

 

4,674

 

Other assets

 

 

288

 

 

 

288

 

Deferred tax assets

 

 

1,586

 

 

 

1,412

 

TOTAL ASSETS

 

$

339,068

 

 

$

357,086

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

 

 

 

Accounts payable

 

$

3,352

 

 

$

2,251

 

Accrued expenses and other current liabilities

 

 

6,389

 

 

 

5,975

 

Operating lease liability, current portion

 

 

568

 

 

 

697

 

Deferred revenue, current portion

 

 

2,081

 

 

 

2,073

 

Income tax payable

 

 

30

 

 

 

18

 

Total current liabilities

 

 

12,420

 

 

 

11,014

 

Operating lease liability, net of current portion

 

 

3,235

 

 

 

3,308

 

Deferred revenue, net of current portion

 

 

55,760

 

 

 

55,934

 

TOTAL LIABILITIES

 

 

71,415

 

 

 

70,256

 

SHAREHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

Preferred shares, no par value per share; unlimited shares authorized

as of March 31, 2021 and December 31, 2020, respectively; 0 shares issued

and outstanding as of March 31, 2021 and December 31, 2020, respectively

 

 

 

 

 

 

Common shares, no par value per share; unlimited shares authorized as of

March 31, 2021 and December 31, 2020; 36,990,710 and 36,902,924 shares

issued and outstanding as of March 31, 2021, and December 31, 2020,

respectively

 

 

384,610

 

 

 

384,313

 

Additional paid-in capital

 

 

7,818

 

 

 

5,875

 

Accumulated deficit

 

 

(124,775

)

 

 

(103,358

)

Total shareholders’ equity

 

 

267,653

 

 

 

286,830

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

 

$

339,068

 

 

$

357,086

 

 

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)

 

 

 

Three Months Ended
March 31,

 

 

 

2021

 

 

2020

 

Revenue:

 

 

 

 

 

 

 

 

Collaboration agreements

 

$

166

 

 

$

 

Operating expenses:

 

 

 

 

 

 

 

 

Research and development, net of tax credits

 

 

16,509

 

 

 

8,632

 

General and administrative

 

 

5,237

 

 

 

2,183

 

Total operating expenses

 

 

21,746

 

 

 

10,815

 

Loss from operations

 

 

(21,580

)

 

 

(10,815

)

Other income (expense), net

 

 

 

 

 

 

 

 

Realized and unrealized loss on foreign exchange

 

 

(31

)

 

 

(1,731

)

Interest income

 

 

64

 

 

 

 

Other expense

 

 

(7

)

 

 

(2

)

Total other income (expense), net

 

 

26

 

 

 

(1,733

)

Loss before income taxes

 

 

(21,554

)

 

 

(12,548

)

Income tax recovery (expense)

 

 

137

 

 

 

(53

)

Net loss and comprehensive loss

 

$

(21,417

)

 

$

(12,601

)

Net loss attributable to common shareholders—basic and diluted

 

$

(21,417

)

 

$

(12,601

)

Net loss per share attributable to common shareholders— basic and diluted

 

$

(0.58

)

 

$

(7.71

)

Weighted-average common shares outstanding—basic and diluted

 

 

36,916,734

 

 

 

1,634,056

 

 

Repare Contact:

Steve Forte
Chief Financial Officer
Repare Therapeutics Inc.
info@reparerx.com

Investors:

Kimberly Minarovich
Argot Partners
repare@argotpartners.com

Media:

David Rosen
Argot Partners
david.rosen@argotpartners.com
212-600-1902

Source: Repare Therapeutics Inc.