RPTX Repare Therapeutics Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
RP-3500
Solid tumors
|
Phase 1/2
Phase 1/2
|
Phase 1/2 dosing of first patient announced July 29, 2020.
|
Latest News
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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 announced that Lloyd M. Segal, President and Chief Executive Officer, will participate in a fireside chat at the Piper Sandler 32nd Annual Virtual Healthcare Conference, being held November 30 – December 3, 2020.
A recording of the fireside chat is currently available in the Investor section of the Company's website at https://ir.reparerx.com/news-and-events/events. A replay of the webcast will be archived on the Company's website for 90 days.
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, as well as RP-6306, it's CCNE1-SL inhibitor and Polθ inhibitor programs. For more information, please visit reparerx.com.
SNIPRx® is a registered trademark of Repare Therapeutics Inc.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201123005588/en/
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– 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
$82,496 as of September 30, 2020 and December 31, 2019, respectively—
82,248
TOTAL CONVERTIBLE PREFERRED SHARES
—
135,997
SHAREHOLDERS' EQUITY (DEFICIT)
Preferred shares, no par value per share; unlimited shares and 0 shares authorized
as of September 30, 2020 and December 31, 2019, respectively; 0 shares issued
and outstanding as of September 30, 2020 and December 31, 2019, respectively—
—
Common shares, no par value per share; unlimited shares authorized as of
September 30, 2020 and December 31, 2019; 36,765,013 and 1,528,374 shares
issued and outstanding as of September 30, 2020, and December 31, 2019,
respectively383,852
1
Additional paid-in capital
5,041
3,811
Accumulated deficit
(88,095
)
(49,941
)
Total shareholders' equity (deficit)
300,798
(46,129
)
TOTAL LIABILITIES, CONVERTIBLE PREFERRED SHARES AND
SHAREHOLDERS' EQUITY (DEFICIT)$
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
$
—
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Repare Therapeutics Inc. ("Repare" or the "Company") (NASDAQ:RPTX), a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics, today announced that Lloyd M. Segal, President and Chief Executive Officer, will participate in a virtual fireside chat at the Morgan Stanley Annual Global Healthcare Conference on Tuesday, September 15 at 10:15 a.m. ET.
A live webcast of the fireside can be accessed in the Investor section of the Company's website at https://ir.reparerx.com/news-and-events/events. A replay of the webcast will be archived on the Company's website for 30 days following the fireside chat.
About Repare Therapeutics, Inc.
Repare Therapeutics is a leading 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200909005307/en/
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Repare Therapeutics Inc. ("Repare") (NASDAQ:RPTX), a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics, today reported financial results for the second quarter ended June 30, 2020, as well as recent operational highlights.
"We set out in 2016 to become the leading precision oncology company focused on synthetic lethality in genomic instability and DNA damage repair, and have since built a strong pipeline of product candidates based upon our proprietary genome-wide, CRISPR enabled SNIPRx platform," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "With the successful completion of our initial public offering in June and our entry into a strategic collaboration with Bristol Myers Squibb in May, we have established a strong cash position to advance our pipeline. I am proud of our entire team and the remarkable progress they have made."
Operational Highlights:
- Initiated a phase 1/2 clinical trial evaluating RP-3500 as a monotherapy and in combination with Pfizer's PARPi, talazoparib. In July 2020, the Company received acceptance from the U.S. Food and Drug Administration (FDA) of an investigational new drug (IND) application and commenced dosing for the first patient in the Phase 1/2 clinical trial of RP-3500.
- Completed initial public offering (IPO). In June 2020, Repare closed an upsized IPO of 12,650,000 of its common shares, including the exercise in full of the underwriters' option to purchase up to an additional 1,650,000 common shares, at a public offering price of $20.00 per share. The net proceeds to Repare, after deducting underwriting commissions and offering expenses, were $232 million.
- Bristol Myers Squibb collaboration. In May 2020, Repare entered into an exclusive, worldwide target discovery collaboration with Bristol Myers Squibb. Repare received an upfront payment from Bristol Myers Squibb of $65 million in Q2 2020, which included a $15 million equity investment in Repare in the form of a warrant that automatically exercised into 750,000 common shares at the public offering price of $20.00 per share upon IPO. In addition, Repare will be eligible to receive additional contingent payments of up to approximately $3 billion in the form of license fees, discovery, development, regulatory and sales-based milestones, in addition to royalty payments on net sales of each product commercialized by Bristol Myers Squibb.
- Appointed new director. In June 2020, Repare appointed Ann D. Rhoads to its Board of Directors and as Chairperson of its Audit Committee.
Second Quarter 2020 Financial Results:
- Cash and restricted cash: Cash and restricted cash as of June 30, 2020 were $370.1 million.
- Research and development expenses, net of tax credits (Net R&D): Net R&D expenses were $9.0 million and $17.6 million for the three and six month periods ended June 30, 2020, respectively, as compared to $4.9 million and $8.6 million in the same periods in the prior year, respectively. Increases in R&D for the three and six month periods ended June 30, 2020 were primarily due to increases in development costs related to Repare's RP-3500 and CCNE1-SL 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 $3.4 million and $5.4 million for the three and six month periods ended June 30, 2020, respectively, as compared to $1 million and $2.1 million in the same periods in the prior year, respectively. Increases in G&A for the three and six month periods ended June 30, 2020 were due to increases in payroll and personnel costs as well as increases in legal, professional and D&O insurance costs, which in turn increased as a result of our recent IPO.
- Net loss: Net loss was $11.8 million, or $2.45 per share in the second quarter of 2020 and $24.4 million, or $7.56 per share, in the first half 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 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 Company's collaboration with Bristol Myers Squibb; the discovery of potential product candidates using SNIPRx® platform; and the clinical development of the Company's pipeline and its research and development programs. 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 final prospectus dated June 18, 2020 and filed with the Securities and Exchange Commission pursuant to Rule 424(b) promulgated under the U.S. Securities Act of 1933, as amended. 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
June 30,
As of
December 31,
2020
2019
ASSETS
CURRENT ASSETS:
Cash
$
369,933
$
94,797
Research and development tax credits receivable
1,414
1,080
Other receivables
2,621
1,976
Prepaid expenses and other current assets
3,296
719
Total current assets
377,264
98,572
Property and equipment, net
2,453
2,390
Restricted cash
199
208
Operating lease right-of-use assets
729
1,034
Other assets
894
359
Deferred tax assets
192
132
TOTAL ASSETS
$
381,731
$
102,695
LIABILITIES, CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS' EQUITY (DEFICIT)
CURRENT LIABILITIES:
Accounts payable
$
3,576
$
2,127
Accrued expenses and other current liabilities
5,262
1,276
Operating lease liability, current portion
608
625
Income tax payable
351
218
Total current liabilities
9,797
4,246
Operating lease liability, net of current portion
136
439
Deferred revenue
58,142
8,142
TOTAL LIABILITIES
68,075
12,827
Series A convertible preferred shares, no par value per share; 0 shares and unlimited shares authorized as of June 30, 2020 and December 31, 2019, respectively; 0 shares and 11,090,135 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively; liquidation and redemption value of $0 and $52,750 as of June 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 June 30, 2020 and December 31, 2019, respectively; 0 shares and 10,468,258 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively; liquidation and redemption value of $0 and $82,496 as of June 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 June 30, 2020 and December 31, 2019, respectively; 0 shares issued and outstanding as of June 30, 2020 and December 31, 2019
—
—
Common shares, no par value per share; unlimited shares authorized as of June 30, 2020 and December 31, 2019; 36,753,454 and 1,528,374 shares issued and outstanding as of June 30, 2020, and December 31, 2019, respectively
383,818
1
Additional paid-in capital
4,182
3,811
Accumulated deficit
(74,344
)
(49,941
)
Total shareholders' equity (deficit)
313,656
(46,129
)
TOTAL LIABILITIES, CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS' EQUITY (DEFICIT)
$
381,731
$
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
June 30,
Six Months Ended
June 30,
2020
2019
2020
2019
Operating expenses:
Research and development, net of tax credits
$
8,951
$
4,853
$
17,583
$
8,556
General and administrative
3,372
1,032
5,555
2,108
Total operating expenses
12,323
5,885
23,138
10,664
Loss from operations
(12,323
)
(5,885
)
(23,138
)
(10,664
)
Other income (expense), net
Realized and unrealized gain (loss) on foreign exchange
595
227
(1,136
)
299
Change in fair value of Series A preferred share tranche obligation
—
(680
)
—
(700
)
Other expense
(4
)
(1
)
(6
)
(3
)
Total other income (expense), net
591
(454
)
(1,142
)
(404
)
Loss before income taxes
(11,732
)
(6,339
)
(24,280
)
(11,068
)
Income tax expense
(70
)
(20
)
(123
)
(129
)
Net loss and comprehensive loss
$
(11,802
)
$
(6,359
)
$
(24,403
)
$
(11,197
)
Net loss attributable to common shareholders—basic and diluted
$
(11,802
)
$
(6,359
)
$
(24,403
)
$
(11,197
)
Net loss per share attributable to common shareholders—basic and diluted
$
(2.45
)
$
(4.16
)
$
(7.56
)
$
(7.33
)
Weighted-average common shares outstanding—basic and diluted
4,825,214
1,528,374
3,229,635
1,528,374
Repare Therapeutics Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(Amounts in thousands of U.S. dollars)
Six Months Ended
June 30,
2020
2019
Cash Flows From Operating Activities:
Net loss and comprehensive loss for the period
$
(24,403
)
$
(11,197
)
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
Share-based compensation expense
660
186
Depreciation expense
403
262
Change in fair value of the Series A preferred shares tranche obligation
—
700
Non-cash lease expense
305
86
Foreign exchange loss (gain)
1,162
(522
)
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
(2,577
)
(155
)
Research and development tax credits receivable
(381
)
(246
)
Other receivables
(725
)
(566
)
Deferred tax asset
(60
)
(42
)
Other non-current assets
(535
)
(15
)
Accounts payable
915
260
Accrued expenses and other current liabilities
2,371
(119
)
Operating lease liability, current portion
(9
)
15
Income tax payable
133
72
Operating lease liability, net of current portion
(292
)
(93
)
Deferred revenue
50,000
8,142
Net cash provided by (used in) operating activities
26,967
(3,232
)
Cash Flows From Investing Activities:
Purchase of property and equipment
(43
)
(380
)
Net cash used in investing activities
(43
)
(380
)
Cash Flows From Financing Activities:
Proceeds from issuance of Series A preferred shares, net
—
20,995
Proceeds from exercise of stock options
488
—
Proceeds from issuance of warrant
15,000
—
Net proceeds from issuance of common shares in initial public offering
233,760
—
Net cash provided by financing activities
249,248
20,995
Effect of exchange rate fluctuations on cash held
(1,045
)
482
Net Increase In Cash And Restricted Cash
275,127
17,865
Cash and restricted cash at beginning of period
95,005
10,929
Cash and restricted cash at end of period
$
370,132
$
28,794
Reconciliation Of Cash And Restricted Cash
Cash
$
369,933
$
28,588
Restricted cash
199
206
Total cash and restricted cash
$
370,132
$
28,794
Supplemental Disclosure Of Cash Flow Information:
Property and equipment purchases in accounts payable
$
423
$
14
Initial public offering costs in accounts payable
$
102
Initial public offering costs in accruals and other current liabilities
$
1,615
$
—
Conversion of Series A and B convertible 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/20200813005641/en/
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- RP-3500 is a potent and selective oral small molecule inhibitor of ATR being developed for the treatment of solid tumors with selected genomic alterations -
- Multi-center trial will evaluate RP-3500 as a monotherapy and in combination with Pfizer's PARP inhibitor, talazoparib (Talzenna®) -
Repare Therapeutics Inc. ("Repare" or the "Company") (NASDAQ:RPTX), a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics, today announced the first patient has been dosed in the 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 with specific genome instability-related genomic alterations including those in ATM gene (ataxia teleangectasia mutated kinase). The multi-center trial will enroll patients with advanced solid tumors of any histology that harbor gene alterations that suggest sensitivity to ATR inhibition as discovered by Repare's proprietary SNIPRx® platform. Dosing follows acceptance by the U.S. Food and Drug Administration (FDA) of the Company's investigational new drug (IND) application earlier this month.
"The TRESR (Treatment Enabled by SNIPRx) study of RP-3500 as a monotherapy or in combination with talazoparib is a promising targeted approach for a range of difficult-to-treat cancers in patients with tumors harboring genetic alterations we have identified and we believe could predict response," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "The RP-3500 development plan reflects our strategy to develop differentiated oncology treatments in highly targeted tumors."
The Phase 1/2 clinical trial is a multi-center, open-label, dose-escalation and expansion trial that is expected to enroll approximately 230 patients with advanced solid tumors of any histology that harbor gene alterations determined pre-clinically to suggest sensitivity to RP-3500 alone or in combination with the PARP inhibitor, talazoparib. The primary outcome measure in the Phase 1 part of the study will be an assessment of safety and tolerability and determination of a dose for the Phase 2 portion of the trial. The Phase 2 monotherapy portion of the trial is expected to further evaluate the efficacy of RP-3500 in biomarker-selected tumors. Additional objectives include assessments of anti-tumor activity, pharmacokinetics (PK), pharmacodynamics (PD) and confirmation of the predictive biomarkers. The first patient dosing took place at The University of Texas MD Anderson Cancer Center ("MDACC") under the direction of the principal investigator Timothy Yap, M.D., Ph.D., Associate Professor in the Department of Investigational Cancer Therapeutics at MDACC. Additional centers in the United States, Canada, and Europe are anticipated to be opened in the near-term for patient recruitment.
RP-3500 has shown substantial anti-tumor activity in multiple preclinical models of solid tumors at doses below the maximum tolerated dose. In preclinical studies, sustained responses were associated with the presence of specific molecular alterations that will be tested in clinical studies. RP-3500 has also shown pre-clinical anti-tumor activity in combination with several PARP inhibitors in the presence of specifically identified genetic alterations. Repare selected talazoparib to test in combination with RP-3500 in collaboration with Pfizer. Talazoparib is being provided by Pfizer to Repare for the purposes of the clinical trial.
About Repare's 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 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 response. 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 www.reparerx.com.
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. All statements other than statements of historical facts are "forward-looking statements," including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as "may," "might," "will," "should," "expect," "plan," "anticipate," "project," "believe," "estimate," "predict," "potential," "intend" or "continue," the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. 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. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the clinical development and therapeutic potential of RP-3500 and the Company's Phase 1/2 clinical trial of RP-3500 including the design of the trial, patient enrollment, clinical site activation and locations. 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 final prospectus dated June 18, 2020 and filed with the Securities and Exchange Commission pursuant to Rule 424(b) promulgated under the U.S. Securities Act of 1933, as amended. Except as required by law, the Company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200729005109/en/