UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 11, 2020
Repare Therapeutics Inc.
(Exact Name of Registrant as Specified in Its Charter)
|
|
|
|
|
|
|
Québec |
|
001-39335 |
|
Not applicable |
|
(State or Other Jurisdiction of Incorporation) |
|
(Commission File Number) |
|
(I.R.S. Employer Identification No.) |
|
|
|
|||
|
7210 Frederick-Banting, Suite 100 St-Laurent, Québec, Canada |
|
H4S 2A1 |
||
|
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: (857) 412-7018
Not Applicable
(Former Name or Former Address, if Changed Since Last Report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
|
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
|
|
|
|
|
|
|
Title of each class |
|
Trading Symbol |
|
Name of each exchange on which registered |
|
Common shares, no par value |
|
RPTX |
|
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
On November 11, 2020, Repare Therapeutics Inc. (the “Company”) issued a press release announcing its recent business highlights and financial results for the three and nine months ended September 30, 2020. A copy of the press release is furnished hereto as Exhibit 99.1 and is incorporated herein by reference.
The information in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section. The information contained herein and in the accompanying exhibit is not incorporated by reference in any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.
|
Item 9.01 |
Financial Statements and Exhibits. |
(d) Exhibits
|
Exhibit |
|
|
|
No. |
|
Description |
|
99.1 |
|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
REPARE THERAPEUTICS INC. |
||
|
|
|
|
|
By: |
|
/s/ Lloyd M. Segal |
|
|
|
Lloyd M. Segal President and Chief Executive Officer |
Dated: November 12, 2020
Exhibit 99.1
Repare Therapeutics Reports Third Quarter 2020 Financial Results and Operational Highlights
– 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, MA & Montreal, QC, November 11, 2020 (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. |
|
|
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 From 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 Contact:
Steve Forte
Chief Financial Officer
Repare Therapeutics Inc.
Investors:
Kimberly Minarovich
Argot Partners
Media:
David Rosen
Argot Partners
212-600-1902
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 |
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
$ |
— |
|