Reported initial camonsertib data from ongoing
Phase 1/2 TRESR and Phase 1b/2 ATTACC clinical trials in a plenary
oral presentation at 2023 AACR Annual Meeting
Camonsertib combination therapy showed 48% CBR
across tumor types regardless of choice of PARP inhibitor or
platinum resistance, with a favorable safety and tolerability
profile
Company on track to report initial RP-6306
monotherapy data from Phase 1 MYTHIC clinical trial in June
2023
Announced the appointment of Susan Molineaux,
Ph.D., and departure of Jerel Davis, Ph.D. on our Board of
Directors, as well as the addition of Daniel Belanger to the senior
leadership team
Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq:
RPTX), a leading clinical-stage precision oncology company, today
reported financial results for the first quarter ended March 31,
2023.
“We continue to execute clinically and across our pipeline
programs, including presenting initial clinical data of camonsertib
in combination with various PARP inhibitors from the ongoing TRESR
and ATTACC trials at this year’s AACR conference,” said Lloyd M.
Segal, President and Chief Executive Officer of Repare. “These
findings are consistent with our preclinical data demonstrating
that low, intermittent dosing of the camonsertib and PARP inhibitor
combinations appears well tolerated and exhibited antitumor
activity, most notably in advanced ovarian cancer. In addition, we
are on track to present initial Phase 1 monotherapy data for
RP-6306 in June.”
First Quarter 2023 Review and Operational Updates:
- Announced initial clinical data from the Phase 1/2 TRESR and
ATTACC trials evaluating camonsertib (RP-3500/RG6526, partnered
with Roche), a potent and selective oral small molecule inhibitor
of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase), in
combination with three poly (ADP-ribose) polymerase (PARP)
inhibitors in a Clinical Trials Plenary Session at the 2023
American Association for Cancer Research (AACR) Annual Meeting.
- Camonsertib combinations appear to be well tolerated. Dose
limiting toxicity in 68 patients treated with the proposed
combination doses were related to myelotoxicity (Grade 3+ anemia
3%, thrombocytopenia 6%, neutropenia 7%, and febrile neutropenia
3%). No prophylactic growth factors were required when
administering the PARP inhibitors at evaluated doses.
- Camonsertib combination resulted in durable clinical benefit
across tumor types and genomic alterations, regardless of choice of
PARP inhibitor and presence of platinum resistance. Overall
clinical benefit rate (CBR) for all patients was 48%. Patients with
platinum-resistant tumors had an overall response rate (ORR) of 12%
and CBR of 49% and benefited similarly to non-platinum-resistant
tumors (ORR 13%, CBR 46%).
- Compelling results were observed particularly in patients with
advanced ovarian cancer (n = 19). In these patients, overall
response was 32%, CBR was 58% and median progression-free survival
was approximately 7 months with treatment greater than 16 weeks and
ongoing in 9 patients.
- Early circulating tumor DNA molecular responses in 66% (31/47)
of evaluable patients confirm antitumor activity of low dose,
intermittent PARP inhibitor + ATR inhibitor therapy. The molecular
response rate (MRR) was significantly higher in patients with
clinical benefit (83%) compared to those without (48%; p=0.015) and
significantly higher than camonsertib monotherapy that was also
administered at higher doses (43% or 27/63; p=0.02). Molecular
responses were also observed in patients with prior PARP inhibitor
exposure (57%) and platinum resistance (64%).
- Repare is conducting dose optimization and efficacy assessments
in tumor specific expansions in the ATTACC study in collaboration
with Roche to support future clinical development plans for
camonsertib combinations with PARP inhibitors.
- Evaluating RP-6306, a first-in-class, oral PKMYT1 inhibitor
as a monotherapy and in combinations in multiple early clinical
studies.
- Repare presented two poster presentations for RP-6306 at the
2023 AACR Annual Meeting regarding the co-mutation landscape in
CCNE1 amplifications and the tumor heterogeneity of copy number in
ovarian and uterine cancers. Additionally, several collaborators
presented preclinical findings on the potential benefits of
combining a Wee1 inhibitor with RP-6306 and the effect of RP-6306
in triple negative breast cancer.
- Repare expects to report initial Phase 1 monotherapy clinical
data for RP-6306 for the treatment of molecularly selected advanced
solid tumors (MYTHIC) in June 2023. The Company expects to report
initial Phase 1 combination therapy clinical data for RP-6306 for
the treatment of molecularly selected advanced solid tumors in the
fourth quarter of the year.
- Repare is working with clinical investigators to initiate
clinical testing, as part of an investigator-sponsored trial (IST),
of a fourth RP-6306 combination with carboplatin, with first
patient dosing expected this year.
- Repare is collaborating with the Canadian Cancer Trials Group
for a basket Phase 2 IST to evaluate RP-6306 in patients with
selected, advanced cancers receiving standard agents that is
expected to begin this year. A sub-study under the master clinical
trial protocol will evaluate RP-6306 in combination with
gemcitabine in patients with CD4/6i-resistant ER+/HER2- metastatic
breast cancer.
- Advancing preclinical programs into clinical
development.
- Repare initiated IND-enabling studies in the first half of this
year for a small molecule, now designated RP-1664, against an
undisclosed target with potential to enter the clinic in late 2023
or early 2024.
- Repare is also pursuing development of an inhibitor of
polymerase theta (Polθ) that is expected to enter the clinic in
2024.
- In April 2023, Repare announced the appointment of Susan
Molineaux, Ph.D., to its Board of Directors, effective as of the
date of the Company’s upcoming annual meeting of shareholders in
June 2023. Concurrent with Dr. Molineaux’s appointment as of the
date of the annual meeting, Jerel Davis, Ph.D., Managing Director
at Versant Ventures and a founding member of Repare’s Board of
Directors, will step down from the Board. Additionally, Repare has
expanded the senior leadership team with the appointment of Daniel
Belanger as EVP Human Resources in May 2023.
First Quarter 2023 Financial Results:
- Cash and cash equivalents and marketable securities:
Cash and cash equivalents and marketable securities as of March 31,
2023 were $314.1 million.
- Revenue from collaboration agreements: Revenue from
collaboration agreements were $5.7 million and $0.4 million for the
three months ended March 31, 2023 and 2022, respectively. The
year-over-year increase in revenue was due to revenue recognized
from our collaboration and license agreement with Roche.
- Research and development expenses, net of tax credits (Net
R&D): Net R&D expenses were $31.8 million and $26.5
million for the three months ended March 31, 2023 and 2022,
respectively. The year-over-year increase in Net R&D expenses
was primarily due to higher personnel related costs from headcount
in support of our development activities, and direct external costs
related to the advancement of preclinical programs into
IND-enabling studies.
- General and administrative (G&A) expenses: G&A
expenses were $8.6 million and $8.8 million for three months ended
March 31, 2023 and 2022, respectively. The year-over-year decrease
in G&A was primarily due to lower professional fees associated
with our collaboration and license agreement with Roche and lower
D&O insurance premiums, offset by higher personnel related
costs.
- Net loss: Net loss was $34.9 million, or $0.83 per
share, in the three months ended March 31, 2023, and $34.8 million,
or $0.83 per share in the three months ended March 31, 2022.
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 tumors in patients most likely to achieve clinical benefit
from resulting product candidates.
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 pipeline includes RP-6306, a PKMYT1
inhibitor currently in Phase 1 clinical development; camonsertib
(also known as RP-3500 or RG6526), a potential leading ATR
inhibitor currently in Phase 1/2 clinical development and partnered
with Roche; a preclinical Polθ inhibitor program; as well as
several undisclosed preclinical programs, including RP-1664. For
more information, please visit reparerx.com.
SNIPRx® is a registered trademark of Repare Therapeutics
Inc.
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 safety,
efficacy and clinical progress of the Company’s clinical programs,
including RP-6306 and camonsertib; the clinical and preclinical
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 RP-6306 and camonsertib and ongoing preclinical
studies and future clinical trials of the Company's RP-1664 and
Polθ inhibitor programs; the Company’s continued development of
camonsertib in partnership with Roche; the status of clinical
trials (including, without limitation, expectations regarding the
data that is being presented, the expected timing of data releases
and development, as well as the completion of clinical trials) and
development timelines for the Company’s product candidates; ; and
the expected benefits of the Company’s collaborations and
partnerships. 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 evolving impact of
macroeconomic events, including the COVID-19 pandemic, rising
inflation, the U.S. Federal Reserve raising interest rates, recent
disruptions in access to bank deposits or lending commitments due
to bank failures and the Russia-Ukraine war, 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 Annual Report on
Form 10-K for the year ended December 31, 2022 filed with the
Securities and Exchange Commission (“SEC”) and the Québec Autorité
des Marchés Financiers ("AMF") on February 28, 2023, 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. For more
information, please visit reparerx.com and follow Repare on Twitter
at @RepareRx and on LinkedIn at
https://www.linkedin.com/company/repare-therapeutics/.
Repare Therapeutics
Inc.
Consolidated Balance
Sheets
(Unaudited)
(Amounts in thousands of U.S.
dollars, except share data)
As of March 31,
As of December 31,
2023
2022
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
121,461
$
159,521
Marketable securities
192,663
184,420
Research and development tax credits
receivable
1,659
1,280
Collaboration revenue receivable
3,996
1,525
Other receivables
1,358
1,518
Prepaid expenses
4,389
5,715
Total current assets
325,526
353,979
Property and equipment, net
5,396
4,228
Operating lease right-of-use assets
4,976
5,371
Other assets
408
497
TOTAL ASSETS
$
336,306
$
364,075
LIABILITIES AND SHAREHOLDERS’
EQUITY
CURRENT LIABILITIES:
Accounts payable
$
3,620
$
461
Accrued expenses and other current
liabilities
17,442
21,645
Operating lease liability, current
portion
2,257
2,171
Deferred revenue, current portion
52,760
53,102
Income tax payable
4,856
1,240
Total current liabilities
80,935
78,619
Operating lease liability, net of current
portion
2,780
3,257
Deferred revenue, net of current
portion
1,347
2,682
TOTAL LIABILITIES
85,062
84,558
SHAREHOLDERS’ EQUITY
Preferred shares, no par value per share;
unlimited shares authorized as of March 31, 2023 and December 31,
2022, respectively; 0 shares issued and outstanding as of March 31,
2023, and December 31, 2022, respectively
—
—
Common shares, no par value per share;
unlimited shares authorized as of March 31, 2023 and December 31,
2022; 42,079,896 and 42,036,193 shares issued and outstanding as of
March 31, 2023 and December 31, 2022, respectively
482,677
482,032
Additional paid-in capital
43,056
37,226
Accumulated other comprehensive loss
(235
)
(428
)
Accumulated deficit
(274,254
)
(239,313
)
Total shareholders’ equity
251,244
279,517
TOTAL LIABILITIES AND SHAREHOLDERS’
EQUITY
$
336,306
$
364,075
Repare Therapeutics
Inc.
Consolidated Statements of
Operations and Comprehensive Loss
(Unaudited)
(Amounts in thousands of U.S.
dollars, except share and per share data)
Three Months Ended March
31,
2023
2022
Revenue:
Collaboration agreements
$
5,678
$
408
Operating expenses:
Research and development, net of tax
credits
31,830
26,458
General and administrative
8,529
8,779
Total operating expenses
40,359
35,237
Loss from operations
(34,681
)
(34,829
)
Other income (expense), net
Realized and unrealized loss on foreign
exchange
(56
)
(17
)
Interest income
3,427
129
Other expense
(15
)
(8
)
Total other income, net
3,356
104
Loss before income taxes
(31,325
)
(34,725
)
Income tax expense
(3,616
)
(32
)
Net loss
$
(34,941
)
$
(34,757
)
Other comprehensive gain:
Unrealized gain on available-for-sale
marketable securities
$
193
$
—
Total other comprehensive gain
193
—
Comprehensive loss
$
(34,748
)
$
(34,757
)
Net loss per share attributable to common
shareholders - basic and diluted
$
(0.83
)
$
(0.83
)
Weighted-average common shares outstanding
- basic and diluted
42,040,674
41,861,613
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230509006025/en/
Repare Contact: Robin Garner Executive Director and Head
of Investor Relations Repare Therapeutics Inc.
investor@reparerx.com
Investors: Matthew DeYoung Argot Partners
repare@argotpartners.com
Media: David Rosen Argot Partners
david.rosen@argotpartners.com 212-600-1902
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