Item 7.01 Regulation FD Disclosure.
On January 7, 2022, Repare Therapeutics (the "Company") issued a press release
providing a business update and highlighting anticipated upcoming milestones
including anticipated data readouts from expansion cohorts of the Company's
clinical trials of RP-3500, the expected initiation of a monotherapy Phase 2
TRESR trial of RP-3500 in the first quarter of 2022, the expected initiation of
a Phase 1 pediatric module of TRESR trial of RP-3500 monotherapy in children in
the first quarter of 2022 and the expected initiation of IND-enabling studies in
the Company's Polq¸ inhibitor program in the first half of 2022. A copy of the
press release is furnished herewith as Exhibit 99.1.
As previously disclosed in December 2021, the Company has initiated its Phase 1
clinical trial of RP-6306 in combination with gemcitabine for the treatment of
molecularly selected advanced solid tumors. Additionally, the Company reaffirms
its previous guidance of reporting early clinical data for RP-6306 in the second
half of 2022.
Management of the Company will present at the upcoming 40th Annual J.P. Morgan
Healthcare Conference on Wednesday, January 13, 2022 at 3:45 p.m. ET. The
presentation will be webcast live and will be available by clicking on an
available link on the Investors section of the Company's website located at
https://ir.reparerx.com/news-and-events/events.
On January 10, 2022, the Company plans to post an updated corporate presentation
dated January 2022 providing a general business update as well as the
aforementioned updates regarding its anticipated upcoming milestones for 2022.
The corporate presentation will be available under the "News and Events" section
of the Company's website, located at
https://ir.reparerx.com/news-and-events/presentations. The Company intends to
use this presentation at the 40th Annual J.P. Morgan Healthcare Conference
beginning on January[10, 2022 as well as in future meetings with analysts,
investors and others from time to time.
The information contained in this Item 7.01, including Exhibit 99.1, is being
furnished and shall not be deemed "filed" for purposes of Section 18 of the
Exchange Act, or otherwise subject to the liabilities of that section, nor shall
such information be deemed incorporated by reference in any filing under the
Securities Act, or the Exchange Act, except as expressly set forth by specific
reference in such a filing.
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, as amended. All
statements in this Current Report on Form 8-K other than statements of
historical fact could be deemed forward looking including, but not limited to,
statements regarding the Company's clinical development plans and business
strategy including statements regarding the Company's plans and timelines for
the clinical development of RP-3500 and RP-6306 including plans and timelines
for pursuing development in any expansion phase(s) of clinical trials as well as
anticipated data readout dates; the potential therapeutic effects and
anticipated clinical benefits of RP-3500 and RP-6306, as a monotherapy and in
combination; and whether preclinical or early clinical results of
RP-3500, RP-6306 and the Company's Polq¸ inhibitor program will be predictive of
future clinical trials. Words such as "plans," "expects," "will," "shall,"
"anticipates," "continue," "expand," "advance," "believes," "guidance,"
"target," "may," "remain," "project," "outlook," "intend," "estimate," "could,"
"should," and other words and terms of similar meaning and expression are
intended to identify forward-looking statements, although not all
forward-looking statements contain such terms. The forward-looking statements
herein speak only as of the date of this Current Report on Form 8-K, and the
Company undertakes no obligation to update these forward-looking statements.
Forward-looking statements are based on management's current beliefs and
assumptions that are subject to risks and uncertainties and are not guarantees
of future performance. Actual results could differ materially from those
contained in any forward-looking statement as a result of various factors,
including, without limitation, 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, the
potential product candidates that the Company develops may not progress through
clinical development or receive required regulatory approvals within expected
timelines or at all, 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 Current Report on Form 8-K are identified
in the section titled "Risk Factors" in the Company's Quarterly Report on Form
10-Q for the quarter ended September 30, 2021 filed with the Securities and
Exchange Commission ("SEC") and the Québec
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Autorité des Marchés Financiers ("AMF") on November 10, 2021, and its other
documents subsequently filed with or furnished to the SEC and AMF. 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.
Item 9.01 Financial Statements and Exhibit.
(d) Exhibits
Exhibit
No. Description
99.1 Press release dated January 7, 2022.
104 Cover Page Interactive Data File (embedded within the Inline XBRL
document).
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