Realigning resources to extend runway to
mid-2027
Focus on clinical development of RP-1664 (PLK4
inhibitor) and RP-3467 (Polθ ATPase inhibitor), with initial
clinical readouts expected beginning in Q3 2025
Exploring partnerships for continued
development of Lunre+Camo and other assets
Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq:
RPTX), a leading clinical-stage precision oncology company, today
announced a re-alignment of resources and a re-prioritization of
its clinical portfolio to focus on the continued advancement of its
Phase 1 clinical programs, RP-1664 (PLK4 inhibitor) and RP-3467
(Polθ ATPase inhibitor). Repare also announced its
intention to seek partnering opportunities across its portfolio,
including for lunresertib and camonsertib (“Lunre+Camo”) prior to
any start of pivotal development. The consequent savings of
late-stage clinical funding combined with planned cost and
headcount reductions are expected to extend Repare’s cash runway
into mid-2027.
“While Lunre+Camo demonstrated positive results from our Phase 1
clinical trial, after careful consideration we have decided to
progress this program into pivotal trials contingent on securing a
strategic partner to fund further development. We are focused on
achieving near-term inflection points for our Phase 1 clinical
assets, RP-1664 and RP-3467, both of which have the potential to
address significant unmet patient needs and deliver important
catalysts in 2025,” said Lloyd M. Segal, President and Chief
Executive Officer of Repare. “Combined with other initiatives,
these changes, which we will implement later this quarter, provide
the foundation for meaningful value creation.”
Recent Pipeline Progress & Upcoming Milestones of
Prioritized Clinical Programs:
RP-1664: First-in-class, highly selective, oral inhibitor of
PLK4
Repare is evaluating RP-1664 as a monotherapy in the Phase 1
LIONS clinical trial in adult and adolescent patients with
TRIM37-high solid tumors.
Upcoming Expected Milestones:
- Q3 2025: Initiation of a Phase 1/2 expansion trial in pediatric
neuroblastoma
- Q4 2025: Initial topline safety, tolerability and early
efficacy data from the LIONS trial
- Mid-2026: Trial completion, final trial readout for
proof-of-concept from the LIONS trial
RP-3467: Potential best-in-class Polθ ATPase
inhibitor
Repare is dosing patients in the Phase 1 POLAR clinical trial
evaluating RP-3467 alone and in combination with the poly-ADP
ribose polymerase (PARP) inhibitor, olaparib. This trial is
enrolling patients with locally advanced or metastatic epithelial
ovarian cancer, metastatic breast cancer, metastatic
castration-resistant prostate cancer, or pancreatic
adenocarcinoma.
Upcoming Expected Milestones:
- Q3 2025: Topline safety, tolerability and early efficacy data
from the POLAR trial in monotherapy and in combination with
olaparib.
Lunresertib and Camonsertib
Repare recently reported positive efficacy and safety data from
the Phase 1 MYTHIC gynecologic expansion clinical trial evaluating
the combination of lunresertib and camonsertib (Lunre+Camo) at the
recommended Phase 2 dose (RP2D) in patients with endometrial cancer
(EC) and platinum-resistant ovarian cancer (PROC). Nearly half of
patients with gynecologic cancers maintained progression-free
survival (PFS) at 24 weeks, comparing favorably to PFS for current
standard of care. Repare intends to seek partnering opportunities
for this program as a condition to advancing the program into
planned and regulatory-supported pivotal development.
Repare is currently evaluating lunresertib in combination with
Debio 0123, a highly selective, brain-penetrant, clinical WEE1
inhibitor, in patients with advanced solid tumors harboring CCNE1
amplification or FBXW7 or PPP2R1A deleterious alterations as part
of an ongoing 50/50 cost sharing collaboration with Debiopharm.
The Company will not continue to develop lunresertib or
camonsertib in other studies, including the ongoing camonsertib
non-small cell lung cancer expansion study, absent securing a
partnership with a development partner.
Upcoming Expected Milestone:
- Q2 2025: Enrollment completion of MYTHIC trial evaluating
lunresertib in combination with Debio 0123 (WEE1 inhibitor)
Cash Position and Financial Guidance:
Repare ended 2024 with approximately $153 million in cash, cash
equivalents and marketable securities, which is anticipated with
the implementation of the cost-saving measures announced above to
fund the Company’s streamlined operations into mid-2027.
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 clinical-stage pipeline includes
RP-1664, a Phase 1 PLK4 inhibitor; RP-3467, a Phase 1 Polθ ATPase
inhibitor; and lunresertib, a PKMYT1 inhibitor, and camonsertib, a
potential leading ATR inhibitor. For more information, please visit
reparerx.com and follow @Reparerx on X (formerly Twitter) and
LinkedIn.
Forward-Looking Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of 1995
and securities laws in Canada. 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 plans for re-prioritization of its portfolio and the
implementation of other cost saving measures, and the expected
impact of such actions; the Company’s preliminary unaudited balance
of cash, cash equivalents and marketable securities as of the end
of 2024 and the Company’s anticipated cash runway; the Company’s
plans to secure a partner to fund further clinical development of
camonsertib and lunresertib; the potential, tolerability, efficacy
and clinical progress of the Company’s product candidates; and the
design, objectives, initiation, timing, progress and results of
current and future preclinical studies and clinical trials of the
Company’s product candidates. 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
potential that success in preclinical testing and earlier clinical
trials does not ensure that later clinical trials will generate the
same results or otherwise provide adequate data to demonstrate the
efficacy and safety of a product candidate; the impacts of
macroeconomic conditions, including the conflict in Ukraine and the
conflict in the Middle East, fluctuations in inflation and
uncertain credit and financial markets, 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 Company’s ability to realize the benefits
of its collaboration and license agreements; 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 quarter ended
September 30, 2024 filed with the Securities and Exchange
Commission (“SEC”) and the Québec Autorité des Marchés Financiers
("AMF") on November 7, 2024. 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. For more information, please visit reparerx.com and follow
Repare on X (formerly Twitter) at @RepareRx and on LinkedIn at
https://www.linkedin.com/company/repare-therapeutics/.
Preliminary Financial Information
Repare’s audited consolidated financial statements at and for
the year ended December 31, 2024 are not yet available. As a
result, the financial information described in this press release
is preliminary and unaudited, represents management’s estimate as
of the date hereof and is subject to completion of Repare’s
financial closing procedures for the fourth quarter and fiscal year
ended December 31, 2024. This preliminary financial information may
materially differ from the actual results that will be reflected in
Repare’s audited consolidated financial statements when such
financial statements are completed and publicly disclosed. Repare’s
independent registered public accounting firm has not conducted an
audit or review of, and does not express an opinion or any other
form of assurance with respect to, Repare’s preliminary
results.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250109975129/en/
Investor Relations & Media: Robin Garner Vice
President and Head of Investor Relations Repare Therapeutics Inc.
investor@reparerx.com
Repare Therapeutics (NASDAQ:RPTX)
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