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Repare Therapeutics Reports Third Quarter 2020 Financial Results and Operational Highlights

·13 min read

– Initiated GLP toxicology studies for newly designated RP-6306, the Company’s CCNE-1 synthetic-lethal inhibitor program

– Phase 1 clinical trial for RP-6306 is anticipated to commence in Q3 2021, reflecting an accelerated timeline from prior guidance

– Initiated a Phase 1/2 clinical trial for RP-3500 as a monotherapy and in combination with talazoparib in patients with solid tumors as previously reported

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 third quarter ended September 30, 2020, as well as recent business highlights.

"Since the closing of our IPO in June, we have made substantial and consistent progress to advance the development of our lead RP-3500 program, entering the clinic in July following the opening of a Phase 1/2 US IND for use as a monotherapy and in combination with talazoparib, all in patients with solid tumors," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "We also expect to initiate a Phase 1 clinical trial for RP-6306 in the third quarter of 2021, ahead of our previously conveyed timeline where we anticipated an IND filing in the second half of 2021. We believe that our work in advancing a first-in-class product candidate into the clinic further validates our progress in identifying new synthetic lethal pairs and developing potent and selective inhibitors."

Third Quarter 2020 Review and Operational Updates:

  • Advanced CCNE-1 synthetic lethal inhibitor (now designated RP-6306) program into Good Laboratory Practice (GLP) toxicology studies ahead of original timeline. The Company anticipates initiating a Phase 1 clinical trial for RP-6306 in the third quarter of 2021, which is ahead of its original guidance of an IND filing in the second half of 2021.

  • Initiated a Phase 1/2 clinical trial evaluating RP-3500 as a monotherapy and in combination with Pfizer's PARP inhibitor, talazoparib, in patients with solid tumors. In July 2020, the Company began dosing in a Phase 1/2 clinical trial of RP-3500, a potent and selective oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase) for the treatment of solid tumors in patients with specific genome instability-related genetic alterations, including those in the ATM gene (ataxia telangiectasia mutated kinase). RP-3500 will be evaluated as a monotherapy and in combination with Pfizer’s PARP inhibitor, talazoparib. Topline results are expected to be reported in the second half of 2021.

  • Inaugurated a newly expanded laboratory and office facility in Montreal, Quebec. In September 2020, the Company materially expanded its research footprint with the addition of 17,000 square feet of combined laboratory and office space in a newly built facility. The new facility more than doubled the Company’s laboratory capacity for its CRISPR-enabled genome-wide synthetic lethal target platform, SNIPRx®, including dedicated space for work related to accelerating all of Repare’s preclinical assets, including those under its research collaboration with Bristol Myers Squibb.

  • Appointed new executive officer. In October 2020, Repare appointed Dr. Laurence F. Akiyoshi as its Executive Vice-President, Organizational and Leadership Development. Dr. Akiyoshi has joined Repare’s executive team after having served as an independent consultant to the Company for the past two years. In addition to his work with Repare, Dr. Akiyoshi has operated a private organizational development consulting practice that has advised numerous companies on scaling their organizations to support rapid growth. His clients have included leadership teams at Apple, LinkedIn, CrowdStrike and Box. Dr. Akiyoshi will be principally focused on organization design, leadership development, and attracting and retaining key team members necessary for Repare’s achievement of its corporate objectives.

Third Quarter 2020 Financial Results:

  • Cash and restricted cash: Cash and restricted cash as of September 30, 2020 were $348.1 million.

  • Research and development expenses, net of tax credits (Net R&D): Net R&D expenses were $10.1 million and $27.7 million for the three and nine month periods ended September 30, 2020, respectively, as compared to $5.6 million and $14.2 million in the same periods in the prior year, respectively. Increases in R&D for the three and nine month periods ended September 30, 2020 were primarily due to increases in development costs related to Repare’s RP-3500 and RP-6306 programs, as well as increases in personnel-related expenses and certain other R&D expenses.

  • General and administrative (G&A) expenses: G&A expenses were $4.0 million and $9.6 million for the three and nine month periods ended September 30, 2020, respectively, as compared to $1.3 million and $3.4 million in the same periods in the prior year, respectively. Increases in G&A for the three and nine month periods ended September 30, 2020 were due to increases in payroll and personnel costs as well as increases in legal, professional and D&O insurance costs in connection with preparations for becoming and now operating as a public company.

  • Net loss: Net loss was $13.8 million, or $0.37 per share in the third quarter of 2020 and $38.2 million, or $2.63 per share, in the first nine months of 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 patients most likely to achieve clinical benefit from resulting product candidates.

About Repare Therapeutics, Inc.

Repare Therapeutics is a leading clinical-state 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, as well as CCNE1-SL inhibitor and Polθ inhibitor 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 discovery of potential product candidates using SNIPRx® platform; and the clinical development of the Company’s pipeline and its research and development programs, including the anticipated timing of its clinical trials of RP-3500 and RP-6306; and the development of preclinical assets pursuant to the Company’s collaboration with Bristol Myers Squibb. 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 period ended June 30, 2020 filed with the Securities and Exchange Commission (the "SEC") on August 13, 20202, and its subsequent filings with the SEC. 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
September 30,

As of
December 31,

2020

2019

ASSETS

CURRENT ASSETS:

Cash

$

347,872

$

94,797

Research and development tax credits receivable

1,637

1,080

Other receivables

3,232

1,976

Prepaid expenses and other current assets

8,524

719

Total current assets

361,265

98,572

Property and equipment, net

3,246

2,390

Restricted cash

203

208

Operating lease right-of-use assets

5,022

1,034

Other assets

288

359

Deferred tax assets

218

132

TOTAL ASSETS

$

370,242

$

102,695

LIABILITIES, CONVERTIBLE PREFERRED SHARES AND

SHAREHOLDERS’ EQUITY (DEFICIT)

CURRENT LIABILITIES:

Accounts payable

$

1,843

$

2,127

Accrued expenses and other current liabilities

4,923

1,276

Operating lease liability, current portion

794

625

Deferred revenue, current portion

2,150

Income tax payable

483

218

Total current liabilities

10,193

4,246

Operating lease liability, net of current portion

3,259

439

Deferred revenue, net of current portion

55,992

8,142

TOTAL LIABILITIES

69,444

12,827

Series A convertible preferred shares, no par value per share; 0 shares and unlimited
shares authorized as of September 30, 2020 and December 31, 2019, respectively; 0
shares and 11,090,135 shares issued and outstanding as of September 30, 2020 and
December 31, 2019, respectively; liquidation and redemption value of $0 and
$52,750 as of September 30, 2020 and December 31, 2019, respectively

53,749

Series B convertible preferred shares, no par value per share; 0 shares and unlimited
shares authorized as of September 30, 2020 and December 31, 2019, respectively; 0
shares and 10,468,258 shares issued and outstanding as of September 30, 2020 and
December 31, 2019, respectively; liquidation and redemption value of $0 and
$82,496 as of September 30, 2020 and December 31, 2019, respectively

82,248

TOTAL CONVERTIBLE PREFERRED SHARES

135,997

SHAREHOLDERS’ EQUITY (DEFICIT)

Preferred shares, no par value per share; unlimited shares and 0 shares authorized
as of September 30, 2020 and December 31, 2019, respectively; 0 shares issued
and outstanding as of September 30, 2020 and December 31, 2019, respectively

Common shares, no par value per share; unlimited shares authorized as of
September 30, 2020 and December 31, 2019; 36,765,013 and 1,528,374 shares
issued and outstanding as of September 30, 2020, and December 31, 2019,
respectively

383,852

1

Additional paid-in capital

5,041

3,811

Accumulated deficit

(88,095

)

(49,941

)

Total shareholders’ equity (deficit)

300,798

(46,129

)

TOTAL LIABILITIES, CONVERTIBLE PREFERRED SHARES AND
SHAREHOLDERS’ EQUITY (DEFICIT)

$

370,242

$

102,695

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
September 30,

Nine Months Ended
September 30,

2020

2019

2020

2019

Operating expenses:

Research and development, net of tax credits

$

10,091

$

5,618

$

27,674

$

14,174

General and administrative

3,996

1,250

9,551

3,358

Total operating expenses

14,087

6,868

37,225

17,532

Loss from operations

(14,087

)

(6,868

)

(37,225

)

(17,532

)

Other income (expense), net

Realized and unrealized gain (loss) on foreign

exchange

290

(152

)

(846

)

147

Change in fair value of Series A preferred share

tranche obligation

(637

)

(1,337

)

Interest income

156

156

Other expense

(4

)

(2

)

(10

)

(5

)

Total other income (expense), net

442

(791

)

(700

)

(1,195

)

Loss before income taxes

(13,645

)

(7,659

)

(37,925

)

(18,727

)

Income tax expense

(106

)

(29

)

(229

)

(158

)

Net loss and comprehensive loss

$

(13,751

)

$

(7,688

)

$

(38,154

)

$

(18,885

)

Net loss attributable to common shareholders—basic and

diluted

$

(13,751

)

$

(7,688

)

$

(38,154

)

$

(18,885

)

Net loss per share attributable to common

shareholders—basic and diluted

$

(0.37

)

$

(5.03

)

$

(2.63

)

$

(12.36

)

Weighted-average common shares outstanding—basic

and diluted

36,756,694

1,528,374

14,486,896

1,528,374

Repare Therapeutics Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(Amounts in thousands of U.S. dollars)

Nine Months Ended
September 30,

2020

2019

Cash Flows From Operating Activities:

Net loss and comprehensive loss for the period

$

(38,154

)

$

(18,885

)

Adjustments to reconcile net loss to net cash provided by (used in) operating activities:

Share-based compensation expense

1,531

313

Depreciation expense

610

416

Change in fair value of the Series A preferred shares tranche obligation

1,350

Non-cash lease expense

520

191

Foreign exchange loss (gain)

835

(432

)

Interest income

(36

)

Changes in operating assets and liabilities:

Prepaid expenses and other current assets

(8,834

)

(142

)

Research and development tax credits receivable

(584

)

(398

)

Other receivables

(1,247

)

(964

)

Deferred tax asset

(86

)

(83

)

Other non-current assets

71

(4

)

Accounts payable

(1,120

)

1,157

Accrued expenses and other current liabilities

3,540

318

Operating lease liability, current portion

(97

)

29

Income tax payable

265

132

Operating lease liability, net of current portion

(351

)

(223

)

Deferred revenue

50,000

8,142

Net cash provided by (used in) operating activities

6,863

(9,083

)

Cash Flows From Investing Activities:

Purchases of property and equipment

(516

)

(561

)

Net cash used in investing activities

(516

)

(561

)

Cash Flows From Financing Activities:

Proceeds from issuance of Series A preferred shares, net

20,995

Proceeds from issuance of Series B preferred shares, net

82,248

Proceeds from exercise of stock options

510

Proceeds from issuance of warrant

15,000

Net proceeds from issuance of common shares in initial public offering

232,043

Net cash provided by financing activities

247,553

103,243

Effect of exchange rate fluctuations on cash held

(830

)

407

Net Increase In Cash And Restricted Cash

253,070

94,006

Cash and restricted cash at beginning of period

95,005

10,929

Cash and restricted cash at end of period

$

348,075

$

104,935

Reconciliation Of Cash And Restricted Cash

Cash

$

347,872

$

104,731

Restricted cash

203

204

Total cash and restricted cash

$

348,075

$

104,935

Supplemental Disclosure Of Cash Flow Information:

Cash interest received

$

120

$

Property and equipment purchases in accounts payable and accrued expenses and

other current liabilities

$

950

$

542

Right-of-use asset obtained in exchange for new operating lease liability

$

4,516

$

1,074

Conversion of Series A and B preferred shares into common shares

$

135,997

$

Conversion of warrant into common shares

$

15,000

$

View source version on businesswire.com: https://www.businesswire.com/news/home/20201111005846/en/

Contacts

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