- Both domvanalimab-containing arms demonstrated differentiated
clinical activity compared to that of zimberelimab alone in a
second interim analysis of ARC-7, our randomized Phase 2 study in
first-line metastatic non-small cell lung cancer (NSCLC)
- Gilead Sciences has initiated its opt-in review process for our
anti-TIGIT program
- If the option is exercised and closed, Arcus would receive a
$275 million opt-in payment, and the parties would share equally
R&D expenses related to the anti-TIGIT program
- A decision is expected prior to the end of 2021
- Updated data from ARC-8, a Phase 1 study of quemliclustat, our
small molecule anti-CD73 inhibitor for pancreatic cancer, is
planned for fall 2021
- Arcus ended the quarter with $743 million of cash and
investments and funding through at least 2023
Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global
biopharmaceutical company focused on developing differentiated
molecules and combination therapies for people with cancer, today
reported financial results for the third quarter ended September
30, 2021 and provided an update on the ARC-7 study of domvanalimab.
Gilead Sciences has initiated its opt-in review process to
potentially obtain rights to the Arcus anti-TIGIT program. If the
option is exercised and closed, Gilead would obtain rights to both
domvanalimab and AB308, a second and differentiated anti-TIGIT
antibody in the Arcus portfolio. A decision is expected prior to
the end of 2021.
“The initiation of Gilead’s opt-in review process for our
anti-TIGIT program is an important step towards our shared
commitment to develop differentiated combination therapies for
people with cancer,” said Terry Rosen, Ph.D., Chief Executive
Officer of Arcus. “We expect to continue our strong momentum of
significant program advancement and milestone achievement starting
with an update this fall from our Phase 1 study of quemliclustat,
our first-in-class small molecule CD73 inhibitor, in development
for pancreatic cancer, an area of enormous unmet need.
Quemliclustat is a central component of our late-stage development
strategy for 2022 and beyond.”
Corporate & Partnership
Updates
- Gilead initiated the opt-in review process for our
anti-TIGIT program. A decision is expected prior to the end of
2021. If Gilead exercises its option, and subject to receipt of
applicable anti-trust approvals:
- Arcus would receive a $275 million opt-in payment, and the
parties would co-develop and share equally the global development
costs related to the anti-TIGIT program.
- Gilead would obtain rights to both domvanalimab, our Fc-silent
anti-TIGIT antibody currently being evaluated in Phase 2 and Phase
3 studies, and AB308, our Fc-enabled anti-TIGIT antibody currently
in a Phase 1 study in advanced malignancies.
- If approved, Arcus and Gilead would co-commercialize and
equally share profits and losses to both anti-TIGIT antibodies in
the United States. Gilead would receive exclusive rights outside
the U.S., subject to any rights of Arcus’s existing partners, and
Gilead would pay to Arcus tiered royalties ranging from the high
teens to low twenties.
- Our collaboration partner Taiho initiated a Phase 1 platform
study evaluating zimberelimab (our anti-PD1 antibody) with
Taiho’s intra-portfolio combinations targeting oncology
indications. The TARP (Taiho-Arcus Platform) study is currently
enrolling. Further details can be found at
https://clinicaltrials.gov Trial Identifier: NCT04999761.
- Zimberelimab was approved in China as a second-line
treatment for recurrent/refractory classical Hodgkin lymphoma
(CHL); Gloria Biosciences holds all rights to zimberelimab in China
and conducts its development of zimberelimab independent of Arcus’s
activities.
Anti-TIGIT program
Recent Highlights
- Arcus conducted a second interim analysis (IA2) for
ARC-7, our open-label randomized Phase 2 study evaluating the
safety and efficacy of domvanalimab plus zimberelimab vs.
zimberelimab alone vs. domvanalimab plus zimberelimab and
etrumadenant (dual adenosine A2a/A2b receptor antagonist) as a
first-line treatment for PD-L1 ≥ 50% and EGFR/ALK wild-type,
metastatic NSCLC. The study has a target total enrollment of 150
patients who are being randomized 1:1:1 across three study arms and
treated until disease progression or loss of clinical benefit. The
timing of this interim analysis was pre-specified in the protocol
to occur when a certain number of patients were randomized and had
at least two disease evaluations.
Summary of Efficacy Observations from IA2:
- Both domvanalimab-containing arms demonstrated differentiated
clinical activity compared to that of zimberelimab alone.
- Zimberelimab alone continued to demonstrate activity similar to
that of other marketed anti-PD-1 antibodies in the setting.
- As expected with immunotherapy treatments, continued deepening
of response and greater tumor shrinkage were observed in patients
with longer follow-up in both domvanalimab-containing arms.
- Since the previous interim analysis, the doublet continued to
show encouraging activity relative to the monotherapy, and the
triplet continued to numerically outperform the doublet.
- As of the data cut-off date for this interim analysis, data for
progression-free survival (PFS) was immature but indicated that
fewer events of progression or death had occurred in the
domvanalimab-containing arms compared to zimberelimab alone.
Summary of Safety Observations from IA2:
- No unexpected safety signals were observed; the current safety
profile for each molecule in the study appeared to be consistent
with known and published immune checkpoint inhibitors in this
setting.
- Early safety data from this interim analysis showed a lower
incidence of infusion reactions relative to published numbers from
other anti-TIGIT plus anti-PD-(L)1 clinical studies.
- Arcus initiated enrollment of five expansion cohorts in the
Phase 1b portion of the ARC-12 study evaluating AB308 plus
zimberelimab in advanced malignancies. This study is designed
to evaluate the safety, tolerability, pharmacokinetic,
pharmacodynamic and clinical activity of AB308 plus zimberelimab in
tumor types believed to be potentially responsive to anti-TIGIT
antibodies.
Upcoming anti-TIGIT
Milestones:
- ARC-7 is expected to be fully enrolled by mid-2022, and we
anticipate a data presentation later in 2022, which will include
progression-free survival data.
- ARC-10, an ongoing registrational Phase 3 study in first-line,
locally advanced or metastatic PD-L1≥50% NSCLC, continues to enroll
and, if positive, is intended to support the potential approvals of
both zimberelimab monotherapy and domvanalimab plus
zimberelimab.
- AstraZeneca and Arcus remain on track to initiate the PACIFIC-8
registrational Phase 3 study to evaluate domvanalimab plus
durvalumab, an anti-PD-L1 antibody, in unresectable Stage 3 NSCLC
with curative intent, where durvalumab is standard of care, by the
end of 2021.
- We are planning several additional clinical studies of
domvanalimab-based combinations, including two additional Phase 3
studies anticipated to start in mid-2022.
Quemliclustat (small molecule anti-CD73
inhibitor)
Upcoming Milestones:
- An update on ARC-8, our Phase I study of quemliclustat plus
zimberelimab and gemcitabine/nab-paclitaxel in first-line
metastatic pancreatic ductal adenocarcinoma (PDAC), is planned for
this fall. This update includes data on approximately 30 patients
treated at the 100mg and 125mg dose of quemliclustat.
- We expect the randomized portion of ARC-8 to complete
enrollment by the end of this month. This 90-patient cohort is
evaluating quemliclustat plus zimberelimab and
gemcitabine/nab-paclitaxel vs. quemliclustat plus
gemcitabine/nab-paclitaxel to determine whether zimberelimab adds
clinical benefit to the combination.
- We anticipate landmark six-month PFS data from the randomized
portion of ARC-8 in mid-2022. These results will inform the design
of our planned Phase 3 study with the goal of starting this first
registrational study for quemliclustat in 2022.
Etrumadenant (A2a/A2b adenosine
receptor antagonist)
Upcoming Milestones:
- ARC-4, our randomized Phase 1b study in EGFR+ NSCLC: we expect
initial randomized data, including overall response rates and PFS,
to be presented in 1H22. ARC-4 is evaluating etrumadenant plus
zimberelimab and chemotherapy vs. zimberelimab plus chemotherapy in
EGFRmut tyrosine kinase inhibitor (TKI)-relapsed and refractory
NSCLC.
- ARC-6, our Phase 1b/2 platform study in metastatic
castration-resistant prostate cancer: we anticipate initial results
in 2022 from the randomized cohort that is evaluating docetaxel
versus docetaxel plus etrumadenant and zimberelimab.
Discovery Programs:
Upcoming Milestones:
- AB308 (Fc-enabled anti-TIGIT antibody) poster presentation at
the 2021 Society for Immunotherapy of Cancer’s (SITC) Annual
Meeting, November 10-14, 2021.
- Poster #258, Title: AB308 is an Anti-TIGIT Antibody That
Enhances Immune Activation and Anti-tumor Immunity Alone and in
Combination with Other I-O Therapeutic Agents.
- AB521 (HIF-2α inhibitor): we expect to initiate Phase 1
clinical development in the fourth quarter of 2021. This first
study is in healthy volunteers and is designed to expeditiously
characterize the pharmacokinetic and safety profile of AB521 and to
identify the starting dose for the planned Phase 1/1b study in
oncology patients.
Financial Results for the Third Quarter
2021
- Cash, cash equivalents and
investments were $743.4 million as of September 30,
2021, compared to $735.1 million as of December 31, 2020. The
increase was primarily due to gross proceeds of $220.4 million
received upon the closing of the private placement of common stock
under the Amended and Restated Stock Purchase Agreement with Gilead
in February 2021, partially offset by cash utilized for our
operations. We expect cash, cash equivalents and marketable
securities on hand to be sufficient to fund operations at least
through 2023.
- Revenues: Collaboration and license revenues were $9.5
million for the three months ended September 30, 2021, compared to
$64.5 million for the same period in 2020. In the three months
ended September 30, 2021, we recognized $7.7 million in
collaboration revenue related to Gilead’s ongoing rights to access
our research and development pipeline in accordance with the Gilead
collaboration agreement, as well as $1.8 million related to the
Taiho collaboration agreement. In the three months ended September
30, 2020, we recognized $55.1 million in revenue related to
Gilead's license to zimberelimab and $7.7 million in collaboration
revenue related to their access to our research and development
pipeline, as well as $1.8 million related to the Taiho
collaboration agreement. Collaboration and license revenues were
$28.4 million for the nine months ended September 30, 2021,
compared to $68.0 million for the same period in 2020.
- R&D Expenses: Research and development expenses were
$71.3 million for the three months ended September 30, 2021,
compared to $51.8 million for the same period in 2020. The increase
was primarily driven by costs incurred to support our expanded
clinical and development activities including increased
compensation costs related to a larger employee base, increased
clinical trial costs, and increased early-stage research costs.
Approximately $4.9 million of the increase in compensation costs is
related to non-cash stock-based compensation. The overall increase
in research and development expenses is partially offset by a
decrease in milestone expenses incurred. Research and development
expenses were $206.4 million for the nine months ended September
30, 2021, compared to $110.6 million for the same period in
2020.
- G&A Expenses: General and administrative expenses
were $16.3 million for the three months ended September 30, 2021,
compared to $11.2 million for the same period in 2020. The increase
was driven by the increased complexity of supporting our expanding
clinical pipeline and collaboration obligations, as well as
compliance costs associated with our growth. Our growing employee
base and 2021 stock awards drove an increase in employee
compensation costs, including approximately $3.7 million of
increased non-cash stock-based compensation. The overall increase
was partially offset by decreases in legal, accounting and
consulting expenses due to costs related to the transaction with
Gilead and other corporate development activities incurred in 2020.
General and administrative expenses were $49.0 million for the nine
months ended September 30, 2021, compared to $29.6 million for the
same period in 2020.
- Net Loss: Net loss was $78.0 million for the three
months ended September 30, 2021, compared to net income of $1.8
million for the same period in the prior year. Net loss was $226.5
million for the nine months ended September 30, 2021, compared to
$71.0 million for the same period in 2020.
Arcus Clinical Study Overview
Trial Name
Arms
Setting
Status
NCT No.
ARC-4
etruma + zim + carbo/pem vs. zim
+ carbo/pem
TKI R/R EGFRmut NSCLC
Ongoing Randomized Phase 1/2
NCT03846310
ARC-6
etruma + zim + SOC vs. SOC
2L/3L CRPC
Ongoing Randomized Phase 2
NCT04381832
ARC-7
zim vs. zim + dom vs. zim + dom +
etruma
1L NSCLC (PD-L1 ≥ 50%)
Ongoing Randomized Phase 2
NCT04262856
ARC-8
quemli + zim + gem/nab-pac vs.
quemli + gem/nab-pac
1L PDAC
Ongoing Randomized Phase 1/1b
NCT04104672
ARC-9
etruma + zim + mFOLFOX vs.
SOC
2L/3L/3L+ CRC
Ongoing
Randomized Phase 2
NCT04660812
ARC-10
chemo vs. zim mono vs. zim +
dom
1L NSCLC (PD-L1 ≥ 50%)
Ongoing Registrational
NCT04736173
ARC-12
AB308 + zim
Advanced Malignancies
Ongoing
Phase 1/1b
NCT04772989
ARC-14
AB521
Healthy Volunteer
Planned
Phase 1
NA
PACIFIC-8
durva ± dom
Curative-Intent Stage 3 NSCLC
Planned Registrational
NA
Carbo/pem: carboplatin/pemetrexed; dom: domvanalimab; durva:
durvalumab; etruma: etrumadenant; gem/nab-pac:
gemcitabine/nab-paclitaxel; quemli: quemliclustat; SOC: standard of
care; zim: zimberelimab CRC: colorectal cancer; CRPC:
castrate-resistant prostate cancer; NSCLC: non-small cell lung
cancer; PDAC: pancreatic ductal adenocarcinoma
About domvanalimab and AB308
Domvanalimab, Arcus’s most advanced anti-TIGIT candidate, is an
Fc-silent investigational monoclonal antibody that binds to TIGIT,
a protein receptor on immune cells that acts as a brake on the
immune response. Cancer cells can exploit TIGIT to avoid detection
by the immune system. Domvanalimab binds to TIGIT to free up immune
activating pathways and activate immune cells to attack and kill
cancer cells.
Treatment with domvanalimab, an Fc-silent antibody, has not been
associated with the depletion of peripheral regulatory T-cells. We
believe this may result in fewer infusion reactions relative to
what has been reported for other anti-TIGIT-containing
regimens.
Arcus is developing a second anti-TIGIT candidate, AB308, an
Fc-enabled investigational monoclonal antibody. AB308 is currently
in a Phase I study for advanced malignancies.
About the Gilead Collaboration
In May 2020, Gilead and Arcus entered into a 10-year
collaboration that provided Gilead immediate rights to zimberelimab
and the right to opt in to all other Arcus programs arising during
the collaboration term. For clinical programs in existence at the
date of the agreement, Gilead’s opt-in payment ranges from $200
million to $275 million per program. For all other programs that
enter clinical development thereafter, the opt-in payments are $150
million per program. Gilead’s option, on a program-by-program
basis, expires after a prescribed period of time following the
achievement of a development milestone for such program and Arcus’s
delivery to Gilead of the requisite qualifying data package.
Concurrent with the collaboration agreement, Gilead and Arcus
entered into a stock purchase agreement under which Gilead made a
$200 million equity investment in Arcus. That stock purchase
agreement was amended and restated in February 2021 in connection
with Gilead’s increased equity stake in Arcus from 13% to 19.5%,
with an additional $220 million investment.
About Arcus Biosciences
Arcus Biosciences is a clinical-stage, global biopharmaceutical
company developing differentiated molecules and combination
medicines for people with cancer. In partnership with industry
partners, patients and physicians around the world, Arcus is
expediting the development of first- or best-in-class medicines
against well characterized biology and pathways and studying novel,
biology-driven combinations that have the potential to help people
with cancer live longer. Founded in 2015, the company has expedited
the development of six investigational medicines into clinical
studies, including new combination approaches that target TIGIT,
PD-1, the adenosine axis (CD73 and dual A2a/A2b) and most recently,
HIF-2alfa. For more information about Arcus Biosciences’ clinical
and pre-clinical programs, please visit www.arcusbio.com or follow
us on Twitter.
Forward-Looking Statements
This press release contains forward-looking statements. All
statements regarding events or results to occur in the future
contained herein, including, but not limited to, statements
regarding the potential exercise, timing and receipt of payments
upon an exercise by Gilead of its option to our anti-TIGIT program,
upcoming milestone and associated timing for our programs,
including those statements under the captions “Upcoming Milestones”
above and expected enrolment in the studies and cohorts described
herein, and our expectation that our cash, cash equivalents and
marketable securities on-hand will be sufficient to fund operations
through at least 2023, are forward-looking statements reflecting
the current beliefs and expectations of management made pursuant to
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. All forward-looking statements involve known
and unknown risks and uncertainties and other important factors
that may cause our actual results, performance or achievements to
differ significantly from those expressed or implied by the
forward-looking statements. Factors that could cause or contribute
to such differences include, but are not limited to: the ability to
obtain regulatory approval for any exercise by Gilead of its
option; risks associated with preliminary and interim data; the
unexpected emergence of adverse events or other undesirable side
effects; the inherent uncertainty associated with the COVID-19
pandemic, including the duration and/or severity of the pandemic
and actions by government authorities to contain or slow the spread
of the virus; the inherent uncertainty associated with
pharmaceutical product development and clinical trials; delays in
our clinical trials due to difficulties or delays in the regulatory
process, enrolling subjects or manufacturing or supplying product
for such clinical trials; our dependence on our collaboration with
Gilead for the successful development and commercialization of our
investigational products; and changes in the competitive landscape
for our programs. Risks and uncertainties facing us are described
more fully in our quarterly report on Form 10-Q for the quarter
ended September 30, 2021 filed on November 8, 2021 with the SEC.
You are cautioned not to place undue reliance on the
forward-looking statements, which speak only as of the date of this
press release. We disclaim any obligation or undertaking to update,
supplement or revise any forward-looking statements contained in
this press release.
The Arcus name and logo are trademarks of Arcus. All other
trademarks belong to their respective owners.
Source: Arcus Biosciences
ARCUS BIOSCIENCES,
INC.
Consolidated Statements of
Operations and Comprehensive Loss
(unaudited)
(In thousands, except share
and per share amounts)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2021
2020
2021
2020
Revenues:
License revenue
$
-
$
55,096
$
-
$
55,096
Collaboration revenue
9,461
9,434
28,383
12,934
Total revenues
9,461
64,530
28,383
68,030
Operating expenses:
Research and development
71,254
51,801
206,412
110,636
General and administrative
16,343
11,177
48,990
29,617
Total operating expenses
87,597
62,978
255,402
140,253
Income (loss) from operations
(78,136
)
1,552
(227,019
)
(72,223
)
Non-operating income (expense):
Interest and other income, net
161
270
481
1,218
Gain on deemed sale from equity method
investee
-
-
-
613
Share of loss from equity method
investee
-
-
-
(613
)
Total non-operating income, net
161
270
481
1,218
Net loss
(77,975
)
1,822
(226,538
)
(71,005
)
Other comprehensive income (loss)
(46
)
(63
)
(136
)
17
Comprehensive loss
$
(78,021
)
$
1,759
$
(226,674
)
$
(70,988
)
Net income (loss) per share, basic
$
(1.11
)
$
0.03
$
(3.28
)
$
(1.37
)
Weighted-average number of shares used to
compute basic net income (loss) per share
70,110,138
62,599,193
68,990,290
51,852,247
Net income (loss) per share, diluted
$
(1.11
)
$
0.03
$
(3.28
)
$
(1.37
)
Weighted-average number of shares used to
compute diluted net income (loss) per share
70,110,138
65,145,707
68,990,290
51,852,247
Selected Consolidated Balance
Sheet Data
(unaudited)
(In thousands)
September 30,
2021
December 31,
2020(1)
Cash, cash equivalents and investments in
marketable securities
$
743,372
$
735,086
Total assets
839,290
772,292
Total liabilities
296,683
269,988
Total stockholders’ equity
542,607
502,304
(1) Derived from the audited financial statements for the year
ended December 31, 2020, included in the Company's Annual Report on
Form 10-K filed with the Securities and Exchange Commission on
February 25, 2021.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211108006055/en/
Investor and Media Inquiries: Holli Kolkey VP of
Corporate Communications (650) 922-1269 hkolkey@arcusbio.com
Arcus Biosciences (NYSE:RCUS)
Gráfico Histórico do Ativo
De Mar 2024 até Abr 2024
Arcus Biosciences (NYSE:RCUS)
Gráfico Histórico do Ativo
De Abr 2023 até Abr 2024