Full Press Release Details
Repare Therapeutics Announces Portfolio Re-Prioritization,
Partnering Initiatives and Cost Reductions
Realigning resources to extend runway to mid-2027
Focus on clinical development of RP-1664 (PLK4 inhibitor) and
RP-3467 (Pol ATPase inhibitor), with initial clinical readouts expected beginning in Q3 2025
Exploring partnerships for continued development of Lunre+Camo and other assets
CAMBRIDGE, Mass. & MONTREAL (BUSINESS WIRE) Jan. 9, 2025 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 (Pol 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:
RP-3467: Potential best-in-class Pol 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:
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.
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.
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 Pol 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 Qu bec Autorit des
March s 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.
Investor Relations & Media Contact:
Vice President and Head of Investor Relations