Initiated patient recruitment of PARP-inhibitor combination arm of
Initiated IND-enabling studies for
Phase 1 clinical trial for
Company to host Virtual Investor Day on
“We met or exceeded key business and program milestones in 2020. In the first half, we secured more than
2020 Highlights and 2021 Outlook:
-
Initiated a Phase 1/2 clinical trial evaluating
RP-3500 as a monotherapy and in combination with Pfizer's PARPi, talazoparib, in patients with solid tumors.-
In
July 2020 , the Company began dosing in a Phase 1/2 clinical trial ofRP-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). -
Repare has now activated 10 clinical trial sites across
North America andEurope , and is now actively screening patients to evaluateRP-3500 in a combination arm with Pfizer’s PARP inhibitor, talazoparib, in addition to monotherapy. - Initial results are expected to be reported in the monotherapy arm of the trial in the second half of 2021.
-
In
-
Advanced
RP-6306 , our CCNE-1 synthetic lethal inhibitor program, into IND enabling studies.-
The Company anticipates initiating a Phase 1 clinical trial for
RP-6306 in the second quarter of 2021, ahead of its previously announced guidance, and plans to host a Virtual Investor Day onThursday, April 8, 2021 to further discuss this program.
-
The Company anticipates initiating a Phase 1 clinical trial for
-
Advanced the development of our earlier stage discovery programs
- Repare is actively pursuing eight discovery pipeline initiatives in addition to its ongoing collaboration with Bristol Myers Squibb. Several of these synthetic lethal discovery targets have progressed into active chemistry programs.
- The Company is now expected to initiate IND enabling studies in H1 2022 for its third synthetic lethal asset, its Polθ inhibitor program, versus previously announced guidance of H2 2021.
-
Corporate Updates
-
In
December 2020 , the Company was added to the NASDAQ Biotechnology Index® (NASDAQ: ^NBI). Repare's addition to the NBI became effective onMonday, December 21, 2020 .
-
In
Fourth Quarter and Full Year 2020 Financial Results:
-
Cash and cash equivalents, restricted cash and marketable securities: Cash and cash equivalents, restricted cash and marketable securities as of
December 31, 2020 were$333.9 million .
-
Research and development expenses, net of tax credits (Net R&D): Net R&D expenses were
$40.1 million and$21.0 million for the years endedDecember 31, 2020 and 2019, respectively. The increase in R&D expenses year over year was primarily due to increases in development costs related to the Company’sRP-3500 andRP-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
$14.3 million and$5.4 million for the years endedDecember 31, 2020 and 2019, respectively. The increase in G&A expenses year over year was due to increases in payroll and personnel costs as well as increases in legal, professional and D&O insurance costs, all of which increased as a result of the Company’s recent IPO and transition to a public company.
-
Net loss: Net loss was
$53.4 million , or$2.66 per share in the year endedDecember 31, 2020 and$27.2 million , or$17.81 per share, in the year endedDecember 31, 2019 .
Conference Call Details for
-
Carol Aghajaian, MD – Chief, Gynecologic Medical Oncology Service, Professor of Medicine,
Weill Cornell Medical College ,Memorial Sloan Kettering Cancer Center ; and -
Timothy Yap , MBBS, PhD, FRCP,Department of Investigational Cancer Therapeutics ,Division of Cancer Medicine , MD Anderson Center
To access the conference call, please dial (833) 638-9655 or (602) 585-9856 (international) at least 10 minutes prior to the start time and refer to conference ID 1093819. Presentation slides will be available to download from the Company’s website.
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
SNIPRx® is a registered trademark of
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; 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
Consolidated Balance Sheets (Unaudited)
(Amounts in thousands of |
||||||||
|
|
As of |
|
|||||
|
|
2020 |
|
|
2019 |
|
||
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
326,184 |
|
|
$ |
94,797 |
|
Marketable securities |
|
|
7,526 |
|
|
|
— |
|
Research and development tax credits receivable |
|
|
2,011 |
|
|
|
1,080 |
|
Other receivables |
|
|
4,153 |
|
|
|
1,976 |
|
Prepaid expenses |
|
|
6,678 |
|
|
|
719 |
|
Total current assets |
|
|
346,552 |
|
|
|
98,572 |
|
Property and equipment, net |
|
|
3,948 |
|
|
|
2,390 |
|
Restricted cash |
|
|
212 |
|
|
|
208 |
|
Operating lease right-of-use assets |
|
|
4,674 |
|
|
|
1,034 |
|
Other assets |
|
|
288 |
|
|
|
359 |
|
Deferred tax assets |
|
|
1,412 |
|
|
|
132 |
|
TOTAL ASSETS |
|
$ |
357,086 |
|
|
$ |
102,695 |
|
LIABILITIES, CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS’ EQUITY (DEFICIT) |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,251 |
|
|
$ |
2,127 |
|
Accrued expenses and other current liabilities |
|
|
5,975 |
|
|
|
1,276 |
|
Operating lease liabilities, current portion |
|
|
697 |
|
|
|
625 |
|
Deferred revenue, current portion |
|
|
2,073 |
|
|
|
— |
|
Income tax payable |
|
|
18 |
|
|
|
218 |
|
Total current liabilities |
|
|
11,014 |
|
|
|
4,246 |
|
Operating lease liabilities, net of current portion |
|
|
3,308 |
|
|
|
439 |
|
Deferred revenue, net of current portion |
|
|
55,934 |
|
|
|
8,142 |
|
TOTAL LIABILITIES |
|
|
70,256 |
|
|
|
12,827 |
|
Series A convertible Preferred Shares, no par value per share; 0 shares and unlimited
shares authorized as of
11,090,135 shares issued and outstanding as of
respectively; liquidation and redemption value of
|
|
|
— |
|
|
|
53,749 |
|
Series B convertible Preferred Shares, no par value per share; 0 shares and unlimited
shares authorized as of
10,468,258 shares issued and outstanding as of
respectively; liquidation and redemption value of
|
|
|
— |
|
|
|
82,248 |
|
TOTAL CONVERTIBLE PREFERRED SHARES |
|
|
— |
|
|
|
135,997 |
|
SHAREHOLDERS’ EQUITY (DEFICIT): |
|
|
|
|
|
|
|
|
Preferred shares, no par value per share; unlimited shares authorized and 0 shares
authorized as
outstanding as of |
|
|
— |
|
|
|
— |
|
Common shares, no par value per share; unlimited shares authorized as
of
outstanding as of |
|
|
384,313 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
5,875 |
|
|
|
3,811 |
|
Accumulated deficit |
|
|
(103,358 |
) |
|
|
(49,941 |
) |
TOTAL SHAREHOLDERS’ EQUITY (DEFICIT) |
|
|
286,830 |
|
|
|
(46,129 |
) |
TOTAL LIABILITIES, CONVERTIBLE PREFERRED SHARES AND SHAREHOLDERS’ EQUITY (DEFICIT) |
|
$ |
357,086 |
|
|
$ |
102,695 |
|
Consolidated Statements of Operations and Comprehensive Loss (Unaudited)
(Amounts in thousands of |
||||||||||||
|
|
Three Months Ended
|
|
Year Ended
|
||||||||
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
||||
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration agreements |
|
$ |
135 |
|
$ |
- |
|
$ |
135 |
|
$ |
- |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development, net of tax credits |
|
|
12,417 |
|
|
6,821 |
|
|
40,091 |
|
|
20,995 |
General and administrative |
|
|
4,792 |
|
|
2,024 |
|
|
14,346 |
|
|
5,382 |
Total operating expenses |
|
|
17,209 |
|
|
8,845 |
|
|
54,437 |
|
|
26,377 |
Loss from operations |
|
|
(17,074) |
|
|
(8,845) |
|
|
(54,302) |
|
|
(26,377) |
Other (expense) income, net |
|
|
|
|
|
|
|
|
|
|
0 |
|
Realized and unrealized (loss) gain on foreign exchange |
|
|
181 |
|
|
565 |
|
|
(664) |
|
|
712 |
Change in fair value of Series A Preferred Share tranche obligation |
|
|
— |
|
|
(13) |
|
|
— |
|
|
(1,350) |
Interest income |
|
|
84 |
|
|
— |
|
|
240 |
|
|
— |
Other expense |
|
|
(6) |
|
|
(1) |
|
|
(16) |
|
|
(6) |
Total other income (expense), net |
|
|
259 |
|
|
551 |
|
|
(440) |
|
|
(644) |
Loss before income taxes |
|
|
(16,815) |
|
|
(8,294) |
|
|
(54,742) |
|
|
(27,021) |
Income tax benefit (expense) |
|
|
1,554 |
|
|
(37) |
|
|
1,325 |
|
|
(195) |
Net loss and comprehensive loss |
|
$ |
(15,261) |
|
$ |
(8,331) |
|
$ |
(53,417) |
|
$ |
(27,216) |
Net loss attributable to common shareholders —basic and diluted |
|
$ |
(15,261) |
|
$ |
(8,331) |
|
$ |
(53,417) |
|
$ |
(27,216) |
Net loss per share attributable to common shareholders —basic and diluted |
|
$ |
(0.41) |
|
$ |
(5.45) |
|
$ |
(2.66) |
|
$ |
(17.81) |
Weighted-average common shares outstanding —basic and diluted |
|
|
36,782,807 |
|
|
1,528,374 |
|
|
20,045,602 |
|
|
1,528,374 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20210304006076/en/
Repare Contact:
Chief Financial Officer
[email protected]
Investors:
[email protected]
Media:
[email protected]
212-600-1902
Source: