– 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
CAMBRIDGE, Mass. & MONTREAL–(BUSINESS WIRE)–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. (Read more…)
- 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. |
||||||||
|
|
|
As of |
|
|
As of |
|
||
|
|
|
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 |
|
|
— |
|
|
|
53,749 |
|
|
Series B convertible preferred shares, no par value per share; 0 shares and unlimited |
|
|
— |
|
|
|
82,248 |
|
|
TOTAL CONVERTIBLE PREFERRED SHARES |
|
|
— |
|
|
|
135,997 |
|
|
SHAREHOLDERS’ EQUITY (DEFICIT) |
|
|
|
|
|
|
|
|
|
Preferred shares, no par value per share; unlimited shares and 0 shares authorized |
|
|
— |
|
|
|
— |
|
|
Common shares, no par value per share; unlimited shares authorized as of |
|
|
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 |
|
$ |
370,242 |
|
|
$ |
102,695 |
|
|
Repare Therapeutics Inc. |
||||||||||||||||
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
|
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. |
||||||||
|
|
|
Nine Months Ended |
||||||
|
|
|
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 |
|
|
$ |
— |
|
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