Presented positive initial data from ongoing
Phase 1 MYTHIC clinical trial evaluating lunresertib alone and in
combination with camonsertib, including an overall RECIST response
rate of 50% in patients with heavily pre-treated gynecological
tumors
Repare to host conference call and webcast to
discuss latest data from its preclinical programs and overall
pipeline, November 15th, 2023 at 8:00 a.m. ET
Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq:
RPTX), a leading clinical-stage precision oncology company, today
reported financial results for the third quarter ended September
30, 2023.
“We substantially advanced our pipeline during the third
quarter, particularly our Phase 1 MYTHIC trial evaluating
lunresertib as a monotherapy and in combination with camonsertib.
The initial data that was presented in a plenary session at the
AACR-NCI-EORTC International Conference on Molecular Targets and
Cancer Therapeutics in October 2023 showed early efficacy signals
across multiple tumor types and in each genotype selected, most
notably in gynecological tumors, along with a favorable safety and
tolerability profile,” said Lloyd M. Segal, President and Chief
Executive Officer of Repare. “Additionally, we look forward to
hosting an investor event focused on our preclinical programs,
RP-1664 and RP-3467, next week, on November 15th, where we will
showcase the strength of our growing pipeline.”
Third Quarter 2023 Review and Operational Updates:
- Advancing lunresertib (RP-6306), a first-in-class,
oral PKMYT1 inhibitor, for the treatment of molecularly selected
advanced solid tumors.
- Presented initial positive data from Modules 1 and 2 of its
ongoing Phase 1 MYTHIC trial evaluating lunresertib alone and in
combination with camonsertib in patients with advanced solid tumors
harboring CCNE1 amplification or FBXW7 or PPP2R1A deleterious
alternations (NCT04855656) at the 2023 AACR-NCI-EORTC International
Conference and additional data from a later cut-off date in a
virtual webcast event hosted by Repare.
- As of the September 5, 2023 data cut-off date as presented
during the company virtual webcast event, the Company reported that
67 patients were enrolled in Module 1 (monotherapy) and 59 patients
in Module 2 (combination therapy).
- In the Module 2 cohort at the combination preliminary
recommended Phase 2 dose (RP2D):
- Protocol-defined overall response (OR) (RECIST or GCIG CA-125
responses) was observed to be 33.3% (N=18). Clinical benefit rate
(CBR) (overall response or stable disease of at least 16 weeks
without tumor progression) was 50.0%.
- In the cohort of patients with gynecologic tumors, the RECIST
response was 50%, OR was 60%, and CBR was 70%. These patients also
had a median of 3 and up to 9 prior lines of therapy, before
administration of lunresertib.
- In all evaluable patients in the trial, across all doses
(N=55), OR was 23.6% and CBR was 41.8%.
- RECIST responses in this ongoing combination trial included 8
confirmed and 3 unconfirmed partial responses (PR). Additionally, 3
patients with ovarian tumors had cancer antigen 125 (CA-125)
responses.
- Encouraging and highly manageable safety and tolerability was
observed for the combination therapy arm of the trial (N=59). The
most common treatment-related adverse event (TRAE) was anemia, with
Grade 3 occurring in 42% of patients enrolled in the trial:
- 35% of patients did not develop anemia at the preliminary RP2D.
Generally, those with Grade 3 anemia had the lowest hemoglobin
values at the time of trial enrollment, were intensely pretreated
with greater than 4 prior therapies and were of advanced age.
- The anemia reported by patients in the trial usually improved
after a one-week treatment interruption and standard supportive
care, and did not lead to any therapy discontinuations for patients
who received treatment at the preliminary RP2D.
- There were no Grade 4 or Grade 5 TRAEs reported at the
preliminary RP2D.
- This data indicates that anemia management can be
individualized and alleviated with simple patient monitoring. This
approach is now being tested in the expansion cohorts of the MYTHIC
trial.
- Repare expects to report additional combination therapy data
from the expansion cohorts of the MYTHIC trial in the second half
of 2024.
- Repare expects to report initial data from its ongoing Phase 1
MINOTAUR trial evaluating lunresertib in combination with FOLFIRI
(NCT05147350) in the first half of 2024. Additionally, the Company
expects to report initial updated data from its ongoing Phase 1
MAGNETIC trial evaluating lunresertib in combination with
gemcitabine (NCT05147272) in the second half of 2024.
- Repare is collaborating with Princess Margaret Cancer Center to
initiate clinical testing, as part of an investigator-sponsored
trial (IST), of a fourth lunresertib combination with carboplatin
and paclitaxel for the treatment of recurrent gynecological
malignancies, with first patient dosing expected to take place by
the end of this year.
- Repare is also collaborating with the Canadian Cancer Trials
Group in an ongoing basket Phase 2 IST that is enrolling patients
with selected, advanced cancers receiving lunresertib as
combination with gemcitabine (NCT05605509), and in a second active
trial that will evaluate lunresertib in combination with
gemcitabine in patients with CDK4/6 inhibitor treated ER+/HER2-
metastatic breast cancer (NCT05601440).
- Advancing camonsertib (RP-3500 / RG6526), a potent
and selective oral small molecule inhibitor of ATR
(Ataxia-Telangiectasia and Rad3-related protein kinase) for the
treatment of tumors with specific synthetic lethal genomic
alterations in partnership with Roche.
- Roche has included a camonsertib-based arm in its Phase 2,
global, multicenter, open-label, multi-cohort TAPISTRY trial
(NCT04589845) and its Phase 1/2 study of multiple
immunotherapy-based treatment combinations in participants with
metastatic non-small cell lung cancer (Morpheus Lung; NCT03337698).
Repare is eligible to receive a milestone payment of $40 million
upon enrollment of the first patient with camonsertib in the
TAPISTRY trial, which is expected by year-end, and could be
eligible for an additional $15 million milestone payment if this
study becomes registrational.
- Repare is continuing to conduct dose optimization and efficacy
assessments in tumor specific expansions in the ATTACC clinical
trial in collaboration with Roche to support future clinical
development plans for camonsertib combinations with PARP
inhibitors.
- Repare also presented clinical and preclinical data from its
ongoing Phase 1b TRESR clinical trial evaluating camonsertib in
combination with gemcitabine in patients with solid tumors with ATR
inhibitor sensitizing mutations at the AACR-NCI-EROTC conference.
The latest data cut from the trial continues to show the benefits
of combination therapy, which has led to anti-tumor activity in
heavily pretreated patients, including 7 patients (N=28) with
confirmed or unconfirmed PRs per RECIST, or GCIG CA-125 responses
(N=28), with responses observed primarily in patients with
gynecologic cancers. Overall molecular response rate (MRR) of 57%,
along with 82% decrease in circulating tumor DNA (ctDNA). The
combination therapy was found to be safe and well-tolerated to
date, with no drug-drug interactions observed. Efficacy assessment
is ongoing at the proposed RP2D in patients with ovarian
cancer.
- Advancing preclinical programs into clinical
development.
- RP-1664 IND-enabling studies, which began in the first quarter
of 2023, are nearing completion and Repare expects to initiate a
clinical trial in the first half of 2024.
- RP-3467 is Repare’s wholly-owned Polθ inhibitor, currently in
IND-enabling studies, which began in the second quarter of 2023 and
remain ongoing. Repare expects to initiate a clinical trial in the
second half of 2024.
Third Quarter 2023 Financial Results:
- Cash and cash equivalents and marketable securities:
Cash and cash equivalents and marketable securities as of September
30, 2023 were $250.1 million, which Repare believes will be
sufficient to fund its planned operations into 2026.
- Revenue from collaboration agreements: Revenue from
collaboration agreements were $2.2 million and $38.1 million for
the three and nine months ended September 30, 2023, respectively,
as compared to $112.5 million and $113.6 million for the three and
nine months ended September 30, 2022. The decrease in revenue for
the three- and nine-month periods were primarily due to a decrease
in revenue recognized under the Roche collaboration mainly as a
result of the $108.0 million revenue recognized in the third
quarter of 2022 pursuant to the satisfaction of our performance
obligations for the issuance of the combined licenses and the
clinical trial materials transferred. The decrease in the
nine-month period was partially offset by higher deferred revenue
recognized from the Roche collaboration, the BMS collaboration and
the Ono collaboration.
- Research and development expenses, net of tax credits (Net
R&D): Net R&D expenses were $32.7 million and $98.3
million for the three and nine months ended September 30, 2023,
respectively, as compared to $31.2 million and $89.2 million for
the three and nine months ended September 30, 2022. The increase in
Net R&D expenses for the three- and nine-month periods were
primarily due to higher personnel-related costs and direct external
costs related to the progress of our lunresertib clinical program,
as well as the advancement of preclinical programs into
IND-enabling studies.
- General and administrative (G&A) expenses: G&A
expenses were $7.9 million and $25.1 million for the three and nine
months ended September 30, 2023, respectively, compared to $7.9
million and $24.6 million for the three and nine months ended
September 30, 2022. The increase in G&A was primarily due to
higher personnel related costs, offset by lower D&O insurance
premiums and lower professional fees.
- Net income (loss): Net loss was $18.9 million, or $0.45
per share, and $65.8 million, or $1.56 per share, in the three and
nine months ended September 30, 2023, respectively, and net income
was $75.5 million, or $1.71 per share, and $2.6 million, or $0.06
per share, in the three and nine months ended September 30, 2022,
respectively.
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 lunresertib (also
known as 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; RP-3467, a preclinical Polθ
inhibitor program; as well as several additional, undisclosed
preclinical programs, including RP-1664. For more information,
please visit reparerx.com and follow @Reparerx on X (formerly
Twitter) and LinkedIn.
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
initiation, timing, progress and results of the Company’s current
and future preclinical studies and clinical trials and related
preparatory work and the period during which the results of the
trials will become available, as well as our research and
development programs; the safety, efficacy and clinical progress of
the Company’s clinical programs, including specifically the
continued further development of lunresertib (also known as
RP-6306) and camonsertib; the timing of the expected combination
therapy data from the expansion cohorts of the MYTHIC trial; the
timing of availability or disclosure of data from the other
clinical trials of lunresertib (also known as RP-6306) and
camonsertib as well as the Phase 1 MINOTAUR trial and ongoing IST
studies; the anticipated initiation of clinical trials of RP-1664
and RP-3467; the ability for the TAPISTRY trial to be deemed a
registrational trial; the Company’s ability to enroll patients in
clinical trials, to timely and successfully complete those trials
and to receive necessary regulatory approvals; the timing of
planned regulatory submissions for lunresertib, camonsertib or the
Company’s other product candidates; the potential for lunresertib,
camonsertib or the Company’s other product candidates to receive
regulatory approval from the FDA or equivalent foreign regulatory
agencies; and the Company’s ability to achieve milestones and
receive associated milestone payments pursuant to the terms of its
collaboration agreements, including pursuant to the Roche
collaboration. 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: 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
COVID-19 pandemic, the conflict in Ukraine, the Hamas-Israel
conflict, rising 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;
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, including
the Company’s Quarterly Report on Form 10-Q for the quarter ended
September 30, 2023 filed with the SEC on November 9, 2023. 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.
Condensed Consolidated Balance
Sheets
(Unaudited)
(Amounts in thousands of U.S.
dollars, except share data)
As of September 30,
As of December 31,
2023
2022
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
107,369
$
159,521
Marketable securities
142,703
184,420
Income tax receivable
15,739
—
Other current receivables
3,731
4,323
Prepaid expenses
5,551
5,715
Total current assets
275,093
353,979
Property and equipment, net
4,722
4,228
Operating lease right-of-use assets
3,883
5,371
Income tax receivable
2,312
—
Other assets
397
497
TOTAL ASSETS
$
286,407
$
364,075
LIABILITIES AND SHAREHOLDERS’
EQUITY
CURRENT LIABILITIES:
Accounts payable
$
5,438
$
461
Accrued expenses and other current
liabilities
20,729
21,645
Operating lease liability, current
portion
2,333
2,171
Deferred revenue, current portion
20,472
53,102
Income tax payable
—
1,240
Total current liabilities
48,972
78,619
Operating lease liability, net of current
portion
1,591
3,257
Deferred revenue, net of current
portion
2,476
2,682
TOTAL LIABILITIES
53,039
84,558
SHAREHOLDERS’ EQUITY
Preferred shares, no par value per share;
unlimited shares authorized as of September 30, 2023 and December
31, 2022, respectively; 0 shares issued and outstanding as of
September 30, 2023, and December 31, 2022, respectively
—
—
Common shares, no par value per share;
unlimited shares authorized as of September 30, 2023 and December
31, 2022; 42,129,251 and 42,036,193 shares issued and outstanding
as of September 30, 2023 and December 31, 2022, respectively
483,184
482,032
Additional paid-in capital
55,515
37,226
Accumulated other comprehensive loss
(252
)
(428
)
Accumulated deficit
(305,079
)
(239,313
)
Total shareholders’ equity
233,368
279,517
TOTAL LIABILITIES AND SHAREHOLDERS’
EQUITY
$
286,407
$
364,075
Repare Therapeutics
Inc.
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,
2023
2022
2023
2022
Revenue:
Collaboration agreements
$
2,159
$
112,545
$
38,086
$
113,632
Operating expenses:
Research and development, net of tax
credits
32,709
31,242
98,327
89,175
General and administrative
7,868
7,904
25,116
24,621
Total operating expenses
40,577
39,146
123,443
113,796
(Loss) income from operations
(38,418
)
73,399
(85,357
)
(164
)
Other income (expense), net
Realized and unrealized (loss) gain on
foreign exchange
(40
)
126
(137
)
250
Interest income
3,312
2,027
10,228
2,700
Other expense
(32
)
(37
)
(73
)
(56
)
Total other income, net
3,240
2,116
10,018
2,894
(Loss) income before income taxes
(35,178
)
75,515
(75,339
)
2,730
Income tax recovery (expense)
16,299
(54
)
9,573
(119
)
Net (loss) income
$
(18,879
)
$
75,461
$
(65,766
)
$
2,611
Other comprehensive (loss)
gain:
Unrealized gain (loss) on
available-for-sale marketable securities
$
172
$
(524
)
$
176
$
(524
)
Total other comprehensive gain (loss)
172
(524
)
176
(524
)
Comprehensive (loss) income
$
(18,707
)
$
74,937
$
(65,590
)
$
2,087
Net (loss) income per share
attributable to common shareholders:
Basic
$
(0.45
)
$
1.80
$
(1.56
)
$
0.06
Diluted
$
(0.45
)
$
1.71
$
(1.56
)
$
0.06
Weighted-average common shares
outstanding:
Basic
42,102,685
41,945,617
42,077,857
41,902,554
Diluted
42,102,685
44,177,376
42,077,857
44,160,481
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231109943377/en/
Repare Contact: Steve Forte Executive Vice-President and
Chief Financial Officer 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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