- Four registrational Phase 3 trials evaluating
domvanalimab-based combinations are ongoing or expected to start by
year-end; Arcus and Gilead Sciences continue to expand their
late-stage clinical program for domvanalimab with the goal of
establishing a best-in-class anti-TIGIT antibody regimen in
multiple cancers.
- An interim analysis was conducted for the ongoing Phase 1/1b
ARC-8 trial of quemliclustat plus chemotherapy, with or without
zimberelimab, in pancreatic ductal adenocarcinoma (PDAC); based on
the results, Arcus and Gilead plan to wait for mature
progression-free survival (PFS) and overall survival (OS) data,
expected in 2023, to inform next steps for the PDAC program.
- On track to initiate ARC-20, a Phase 1/1b study to evaluate
AB521, Arcus’s HIF-2a inhibitor, in cancer patients in Q3 2022;
data from the ongoing healthy volunteer study enable Arcus to start
dose escalation in patients at a pharmacologically relevant dose
level.
- Arcus nominated a new development candidate, AB801 (an AXL
inhibitor), in the second quarter; and at least two new molecules
are expected to advance into the clinic in 2023.
- Arcus is well positioned to advance its expanding programs and
portfolio, with $1.3 billion in cash, and cash equivalents and
funding into 2026.
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 second quarter ended June 30,
2022 and provided a pipeline update on its six clinical-stage
molecules – targeting TIGIT, the adenosine axis (CD73 and A2a/A2b),
HIF-2a and PD-1 – across multiple common cancers. Arcus and Gilead
continue to rapidly advance Arcus’s broad and diverse pipeline, and
the companies remain on track to have four ongoing registrational
Phase 3 trials of domvanalimab-based combinations in non-small cell
lung cancer (NSCLC) and gastrointestinal (GI) cancers by year-end.
Topline disclosure from the Phase 2 ARC-7 study is expected in the
second half of 2022 with a planned presentation of the data at a
medical conference in 2023. Arcus continues to advance its next
wave of novel molecules, with at least two INDs expected in
2023.
“This is a transformational year in the evolution of Arcus, as
we expand the scope of our global clinical programs to include four
registrational Phase 3 trials with domvanalimab-based
combinations,” said Terry Rosen, Ph.D., chief executive officer of
Arcus. “The data we have generated in our Phase 2 ARC-7 study
support our conviction in the initiation of two new registrational
Phase 3 trials with our domvanalimab plus zimberelimab anti-TIGIT /
anti-PD-1 doublet regimen, and we intend to be the leader in
bringing anti-TIGIT-based therapies to patients. Our strong cash
position and strategic collaborations enable us to maintain
competitive positioning and execute efficiently in disease areas
with significant patient populations and high unmet need, including
lung and upper GI cancers.”
Anti-TIGIT program (domvanalimab and
AB308)
Update on Domvanalimab:
- Arcus is on track to complete enrollment in Q3 2022 of 150
patients for ARC-7, a randomized Phase 2 study evaluating the
safety and efficacy of zimberelimab alone vs. domvanalimab plus
zimberelimab vs. domvanalimab plus zimberelimab and etrumadenant in
first-line PD-L1≥50% metastatic NSCLC.
- Arcus and Gilead are pursuing a broad development program for
domvanalimab-based combinations in NSCLC, with three ongoing or
soon-to-be initiated registrational Phase 3 trials:
- STAR-121, evaluating the combination of domvanalimab plus
zimberelimab and chemotherapy versus pembrolizumab with
chemotherapy in first-line NSCLC PD-L1 all-comers, is expected to
achieve first site initiation in the third quarter and is being
operationalized by Gilead.
- ARC-10 is evaluating domvanalimab plus zimberelimab vs.
zimberelimab alone vs. chemotherapy in first-line PD-L1≥50% locally
advanced or metastatic NSCLC.
- PACIFIC-8, operationalized by AstraZeneca, is evaluating
domvanalimab plus durvalumab, an anti-PD-L1 antibody, in
unresectable Stage III NSCLC.
- The companies are also advancing the study of domvanalimab plus
zimberelimab-based combinations with two new studies in GI cancers,
which are on track to start by year-end:
- ARC-21, a Phase 2 trial evaluating domvanalimab plus
zimberelimab-based combinations in upper GI cancers, is open for
enrollment and is intended to support the registrational Phase 3
trial STAR-221.
- STAR-221, a randomized Phase 3 study, will evaluate a
domvanalimab plus zimberelimab-based combination in upper GI
cancers.
Upcoming Anti-TIGIT Milestones:
- Topline disclosure from the Phase 2 ARC-7 study is expected in
the second half of 2022 with a planned presentation of the data at
a medical conference in 2023.
- Arcus and Gilead expect to initiate two Phase 2 platform lung
studies evaluating novel domvanalimab-based combinations, including
domvanalimab plus zimberelimab-based triplet combinations with
etrumadenant, Trodelvy® (sacituzumab govitecan-hziy), and/or
quemliclustat, by year-end.
Etrumadenant (A2a/A2b adenosine
receptor antagonist)
Upcoming Etrumadenant Milestones:
- Topline disclosure from the Phase 2 ARC-7 study is expected in
the second half of 2022 with a planned presentation of the data at
a medical conference in 2023.
- Data from the randomized cohort of ARC-6 evaluating
etrumadenant plus zimberelimab and docetaxel versus docetaxel in
second-line metastatic castrate-resistant prostate cancer (CRPC)
are anticipated in-house in the second half of 2022 with a
presentation of results expected in 2023.
- Data from ARC-9, a Phase 1b/2 study evaluating
etrumadenant-based combinations in second-line and third-line
metastatic colorectal cancer (mCRC), are expected in the first half
of 2023.
Quemliclustat (small-molecule CD73
inhibitor)
Update on ARC-8:
- The ARC-8 study includes two stages: the first stage is a
dose-escalation and dose-expansion stage evaluating quemliclustat
plus a chemotherapy doublet and zimberelimab (the quad) followed by
the second stage, a randomized cohort comparing the quad versus
quemliclustat plus a chemotherapy doublet in first-line PDAC.
- Arcus conducted an interim analysis for ARC-8, which included
patients from the first stage of the trial and the initial
two-thirds of patients from the second stage.
- At this interim analysis, we continued to observe encouraging
data from patients treated in the first stage of ARC-8. However,
data from patients treated in the randomized portion were similar
to historical benchmarks for chemotherapy alone.
- At the time of data cut off, no unexpected safety signals were
observed.
- The companies plan to wait for more mature PFS and overall
survival data from all 90 patients in the randomized cohort to
inform next steps for the PDAC program. These data are expected in
the first half of 2023.
Upcoming Quemliclustat Milestones:
- As mentioned above, Arcus and Gilead expect to initiate a Phase
2 platform study to evaluate domvanalimab and quemliclustat
combinations in NSCLC by year-end. We also expect to explore
quemliclustat-based combinations in GI cancers in the ARC-21
study.
AB521 (HIF-2a inhibitor)
AB521 Update:
- Arcus is on track to initiate ARC-20, a Phase 1/1b study to
explore the safety and clinical activity of AB521 in cancer
patients in Q3 2022. Data from the ongoing healthy volunteer study
enable Arcus to start dose escalation in patients at a
pharmacologically relevant dose level. Pharmacokinetic
(PK)/pharmacodynamic (PD) data for AB521 in healthy volunteers
demonstrate its potential to have an improved clinical profile
compared to the approved HIF-2a inhibitor.
Discovery Programs:
- AB598 (anti-CD39 antibody) continues to progress through
preclinical development, and we expect to file an Investigational
New Drug (IND) application and initiate a Phase 1 trial in cancer
patients in the first half of 2023.
- Arcus nominated a new small molecule development candidate,
AB801, a potent and selective AXL inhibitor, which has the
potential to address various treatment-resistant tumor types, such
as STK11-mutant NSCLC.
- Arcus expects to nominate a potential first-in-class small
molecule candidate designed to treat a wide range of inflammatory
conditions in the second half of 2022.
- As part of Arcus’s and Gilead’s research collaboration, the
companies have now selected targets for the two drug discovery
programs in oncology. Upon completion of certain IND-enabling
activities, Gilead has the right to exercise its option for a
payment of $60 million for each program.
Financial Results for the Second
Quarter 2022
- Cash, cash equivalents and investments: were $1,271.1
million as of June 30, 2022, compared to $681.3 million as of
December 31, 2021. The increase was primarily due to the receipt of
$725 million from Gilead in January 2022. Arcus expects cash, cash
equivalents and marketable securities on-hand to be sufficient to
fund operations into 2026.
- Revenues: Collaboration and license revenues were $26.8
million for the three months ended June 30, 2022, compared to $9.5
million for the same period in 2021. In the three months ended June
30, 2022, Arcus recognized $16.7 million in license and development
service revenues for all programs optioned by Gilead, based on
estimates of progress made toward satisfying the related
performance obligations, $8.3 million in collaboration revenue
related to Gilead’s ongoing rights to access Arcus's research and
development pipeline in accordance with the Gilead collaboration
agreement, as well as $1.8 million related to the collaboration
agreement with Taiho. In the three months ended June 30, 2021,
Arcus recognized $7.7 million in other collaboration revenue
related to Gilead's access to Arcus's research and development
pipeline, as well as $1.8 million related to the Taiho
collaboration agreement. Collaboration and license revenues were
$44.8 million for the six months ended June 30, 2022, compared to
$18.9 million for the same period in 2021.
- R&D Expenses: Research and development expenses were
$69.9 million for the three months ended June 30, 2022, compared to
$68.8 million for the same period in 2021. Arcus’s expanding
clinical and development activities for domvanalimab and
zimberelimab drove increases in manufacturing and clinical costs.
Arcus’s growing employee base and 2022 stock awards drove an
increase in employee compensation costs, including a $0.7 million
increase in non-cash stock-based compensation to approximately $7.7
million. The above increases in research and development costs were
mostly offset by increased cost-sharing reimbursements compared to
the same quarter in the prior year. The increase in cost-sharing
reimbursements was driven by the four programs optioned by Gilead
in the current quarter, compared to a single program in the same
quarter of the prior year. Research and development expenses were
$131.1 million for the six months ended June 30, 2022, compared to
$135.2 million for the same period in 2021.
- G&A Expenses: General and administrative expenses
were $25.8 million for the three months ended June 30, 2022,
compared to $16.8 million for the same period in 2021. The increase
was driven by the increased administrative costs to support the
growing size and complexity of Arcus's clinical development
organization associated with Arcus's expanding clinical pipeline
and collaboration obligations. Arcus's growing employee base and
2022 stock awards drove increases in employee compensation costs
and facilities expense, including a $1.6 million increase in
non-cash stock-based compensation to approximately $8.0 million for
the three months ended June 30, 2022 compared to the prior year
period. General and administrative expenses were $49.8 million for
the six months ended June 30, 2022, compared to $32.6 million for
the same period in 2021.
- Net Loss: Net loss was $66.6 million for the three
months ended June 30, 2022, compared to a net loss of $76.0 million
for the same period in the prior year. Net loss was $134.6 million
for the six months ended June 30, 2022, compared to a net loss of
$148.6 million for the same period in the prior year.
Arcus Ongoing and Announced Clinical Studies
Trial Name
Arms
Setting
Status
NCT No.
Lung Cancer
ARC-7
zim vs. dom + zim vs. etruma +
dom + zim
1L NSCLC (PD-L1 ≥ 50%)
Ongoing Randomized Phase 2
NCT04262856
PACIFIC-8
(AZ)
dom + durva vs. durva
Curative-Intent Stage 3 NSCLC
Ongoing Registrational Phase
3
NCT05211895
ARC-10
dom + zim vs. zim vs. chemo
1L NSCLC (PD-L1 ≥ 50%)
Ongoing Registrational Phase
3
NCT04736173
STAR-121
(GILD)
dom + zim + chemo vs pembro +
chemo
1L NSCLC (PD-L1 all-comers)
Planned Registrational Phase
3
TBD
EDGE-Lung
dom + zim +/- quemli
1L/2L NSCLC (lung cancer platform
study)
In Planning Phase 2
TBD
Lung Platform (GILD)
dom + zim +/- etruma or
sacituzumab govitecan (Trodelvy) or other combos
1L/2L NSCLC (lung cancer platform
study)
In Planning Phase 2
TBD
Gastrointestinal Cancers
ARC-9
etruma + zim + mFOLFOX vs.
SOC
2L/3L/3L+ CRC
Ongoing
Randomized Phase 2
NCT04660812
ARC-21
dom + zim ± chemo
1L/2L Upper GI Malignancies
Ongoing
Phase 2
NCT05329766
STAR-221
dom + zim + chemo vs. nivo +
chemo
GI Malignancies
Planned Registrational Phase
3
TBD
Pancreatic Cancer
ARC-8
quemli + zim + gem/nab-pac vs.
quemli + gem/nab-pac
1L, 2L PDAC
Ongoing Randomized Phase 1/1b
NCT04104672
Prostate Cancer
ARC-6
etruma + zim + SOC vs. SOC
(Adding sacituzumab govitecan (Trodelvy) combination cohorts)
2L/3L CRPC
Ongoing Randomized Phase 2
NCT04381832
Various
ARC-12
AB308 + zim
Advanced Malignancies
Ongoing
Phase 1/1b
NCT04772989
ARC-14
AB521
Healthy Volunteers
Ongoing
NCT05117554
ARC-20
AB521
Cancer Patients / ccRCC
Planned Phase 1/1b
TBD
dom: domvanalimab; durva: durvalumab; etruma: etrumadenant;
gem/nab-pac: gemcitabine/nab-paclitaxel; nivo: nivolumab; pembro:
pembrolizumab; quemli: quemliclustat; SOC: standard of care; zim:
zimberelimab; ccRCC: clear-cell renal cell carcinoma
CRC: colorectal cancer; CRPC: castrate-resistant prostate
cancer; GI: gastrointestinal; NSCLC: non-small cell lung cancer;
PDAC: pancreatic ductal adenocarcinoma
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 into all other Arcus programs arising during
the collaboration term. In November 2021, Gilead and Arcus amended
the collaboration in connection with Gilead’s option exercise for
three of Arcus’s then-clinical stage programs. For all other
programs that are in clinical development or new 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 specified 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 May 2020 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.
Gilead and Arcus are co-developing and equally share global
development costs for five clinical candidates, including
domvanalimab, an Fc-silent anti-TIGIT antibody, etrumadenant, a
dual adenosine A2a/A2b receptor antagonist, quemliclustat, a small
molecule inhibitor of CD73, and zimberelimab, an anti-PD1
antibody.
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 biological targets 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 receptor) and most recently, HIF-2a. 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, the statements in
Dr. Rosen’s quote, Arcus’s expectation that its cash, cash
equivalents and marketable securities on-hand are sufficient to
fund operations into 2026, future data disclosures and
presentations, the projected achievement of clinical study
milestones and their associated timing (including under the
captions “Upcoming Anti-TIGIT Milestones,” “Upcoming Etrumadenant
Milestones,” “Upcoming Quemliclustat Milestones,” “AB521 Update,”
and “Discovery Programs”), and additional clinical studies in
planning or expected to be initiated this year 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 Arcus’s
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: risks associated with preliminary and
interim data not being guarantees that future data will be similar;
the unexpected emergence of adverse events or other undesirable
side effects; difficulties or delays in initiating or conducting
clinical trials due to difficulties or delays in the regulatory
process, enrolling subjects or manufacturing or supplying product
for such clinical trials, all of which may be exacerbated by the
COVID-19 pandemic; Arcus’s dependence on the collaboration with
Gilead for the successful development and commercialization of its
optioned molecules; difficulties associated with the management of
the collaboration activities or expanded clinical programs; changes
in the competitive landscape for Arcus’s programs; and the inherent
uncertainty associated with pharmaceutical product development and
clinical trials. Risks and uncertainties facing Arcus are described
more fully in its Quarterly Report on Form 10-Q for the quarter
ended June 30, 2022, filed on August 3, 2022 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.
Arcus disclaims any obligation or undertaking to update, supplement
or revise any forward-looking statements contained in this press
release except to the extent required by law.
The Arcus name and logo are trademarks of Arcus Biosciences,
Inc. All other trademarks belong to their respective owners.
ARCUS BIOSCIENCES,
INC.
Consolidated Statements of
Operations and Comprehensive Loss
(unaudited)
(In thousands, except share
and per share amounts)
Three Months Ended
Six Months Ended
June 30,
June 30,
2022
2021
2022
2021
Revenues:
License and development service
revenue
$
16,693
$
-
$
24,632
$
-
Other collaboration revenue
10,066
9,461
20,132
18,922
Total revenues
26,759
9,461
44,764
18,922
Operating expenses:
Research and development
69,905
68,771
131,116
135,158
General and administrative
25,836
16,826
49,810
32,647
Total operating expenses
95,741
85,597
180,926
167,805
Loss from operations
(68,982
)
(76,136
)
(136,162
)
(148,883
)
Non-operating income (expense):
Interest and other income, net
2,861
166
3,443
320
Effective interest on liability for sale
of future royalties
(511
)
-
(902
)
-
Total non-operating income, net
2,350
166
2,541
320
Net loss before income taxes
(66,632
)
(75,970
)
(133,621
)
(148,563
)
Income tax expense
-
-
(1,004
)
-
Net loss
(66,632
)
(75,970
)
(134,625
)
(148,563
)
Other comprehensive loss
(2,584
)
(44
)
(5,983
)
(90
)
Comprehensive loss
$
(69,216
)
$
(76,014
)
$
(140,608
)
$
(148,653
)
Net loss per share, basic and diluted
$
(0.93
)
$
(1.09
)
$
(1.88
)
$
(2.17
)
Weighted-average number of shares used to
compute basic and diluted net loss per share
71,814,232
69,745,297
71,506,216
68,421,086
Selected Consolidated Balance
Sheet Data
(unaudited)
(In thousands)
June 30,
December 31,
2022
2021(1)
Cash, cash equivalents and investments in
marketable securities
$
1,271,105
$
681,298
Total assets
1,476,773
1,591,898
Total liabilities
729,387
750,448
Total stockholders’ equity
747,386
841,450
(1) Derived from the audited financial statements for the year
ended December 31, 2021, included in the Company's Annual Report on
Form 10-K filed with the Securities and Exchange Commission on
February 23, 2022.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220803005357/en/
Investor Inquiries: Pia
Banerjee Head of Investor
Relations & Strategy (617) 459-2006 pbanerjee@arcusbio.com
Media Inquiries: Holli Kolkey VP of Corporate
Communications (650) 922-1269 hkolkey@arcusbio.com
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