- Presented data from the ongoing ARC-7 Phase 2 trial in
non-small cell lung cancer at American Society of Clinical Oncology
(ASCO); Fc-silent anti-TIGIT monoclonal antibody domvanalimab
continued to demonstrate clinically meaningful improvements over
anti-PD-1 monotherapy across all measures evaluated, including
progression-free survival, overall response rate, and duration of
response
- Initiated the dose-expansion phase of the Phase 1b ARC-20 study
of AB521, a potential best-in-class HIF-2a inhibitor, in clear-cell
renal cell carcinoma patients (ccRCC) at a dose of 100 mg daily;
pharmacokinetic, pharmacodynamic and safety data, along with any
preliminary signs of anti-tumor activity from the dose-escalation
phase are expected in late 2023 or early 2024
- An analysis of data from the Phase 1/1b ARC-8 study of
quemliclustat was conducted; the overall survival (OS) data were
encouraging relative to historical benchmarks for chemotherapy
alone and will be submitted for presentation at a future scientific
conference
- Based on our most recent analysis of data from ARC-6, the
etrumadenant-based combination is not expected to demonstrate
sufficient clinical benefit in castrate resistant prostate cancer
to warrant further investment; ARC-9 data in colorectal cancer are
expected in the first half of 2024
- With $1.0 billion in cash, cash equivalents and marketable
securities and funding into 2026, Arcus is well positioned to
advance its pipeline.
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,
2023, and provided a pipeline update on its clinical-stage
investigational molecules – targeting TIGIT, the adenosine axis
(CD73 and A2a/A2b receptors), HIF-2a and PD-1 – across multiple
common cancers.
“Beyond our broad development program for domvanalimab, our
potentially best-in-class Fc-silent anti-TIGIT antibody, in lung
and upper GI cancers, our pipeline continues to mature with
multiple clinical-stage molecules being evaluated across common
cancers of high unmet need. In addition, our discovery platform is
expected to continue to generate at least one IND per year, and we
expect to advance two new molecules into the clinic prior to the
end of 2023,” said Terry Rosen, Ph.D., chief executive officer of
Arcus. “By early next year, we expect to present several key
datasets across our pipeline, including data from our Phase 2
EDGE-Gastric study (ARC-21) for domvanalimab in first-line gastric
cancer, overall survival data from ARC-8 for quemliclustat in
pancreatic cancer, and data from the Phase 1b ARC-20 study for
AB521, our HIF-2a inhibitor.”
Pipeline Highlights:
Domvanalimab (Fc-silent anti-TIGIT
monoclonal antibody)
- Arcus and Gilead presented interim data from the ongoing ARC-7
study at the American Society of Clinical Oncology (ASCO) Annual
Meeting in June 2023.
- At the time of data cutoff (DCO), February 7, 2023, safety and
efficacy were evaluated in all patients treated (n=150).
- With a median follow-up time of approximately 18 months, both
domvanalimab-containing study arms demonstrated sustained,
clinically meaningful improvements in progression-free survival
(PFS) compared to zimberelimab (Z) monotherapy, with a 33%
reduction in risk of disease progression or death for the doublet
and 28% for the triplet.
- As of the DCO, approximately twice as many participants
remained on study treatment in each of the domvanalimab-containing
arms compared to zimberelimab monotherapy. Preliminary duration of
response (DoR) analyses also substantially favored the
domvanalimab-containing arms.
- Consistent ORR and PFS improvements were observed for the
domvanalimab-containing arms in a post-hoc analysis of centrally
confirmed PD-L1-high patients.
- All treatment combinations were generally well tolerated; no
new safety signals were observed across the three study arms.
- Initial ORR data from the ongoing EDGE-Gastric (ARC-21) Phase 2
study of domvanalimab plus zimberelimab and chemotherapy in
first-line upper GI cancers are anticipated in the fourth quarter
of 2023. These data will be from the cohort that includes the same
patient population and dosing regimen as the ongoing Phase 3 study,
STAR-221.
- Domvanalimab has the potential to be first-to-market in this
indication, since it is currently the only anti-TIGIT antibody in
late-stage clinical development for gastric, esophageal, and
gastro-esophageal junction adenocarcinoma. These tumor types
represent a potential drug-treatable population of over 25,000 in
the US and over 100,000 in G-7 countries.
AB521 (HIF-2a inhibitor)
- Arcus has initiated the dose-expansion stage of ARC-20, a Phase
1/1b study of AB521 in ccRCC patients, evaluating a 100-mg daily
dose, which Arcus believes has the potential to achieve at least 3
times higher levels of the HIF-2a inhibitor than those equivalent
to the approved dose of the marketed competitor. No dose-limiting
toxicities have been observed to date in ARC-20.
- Initial pharmacokinetic (PK), pharmacodynamic (PD) and safety
data, along with any preliminary signs of anti-tumor activity from
the dose-escalation phase of ARC-20, are expected in late 2023 or
early 2024. Efficacy data from the dose-expansion stage of the
ARC-20 study are anticipated later in 2024.
- A Phase 2 study evaluating AB521 in combination with other
agents is anticipated to begin in the fourth quarter of 2023.
Quemliclustat (small-molecule CD73
inhibitor)
- Arcus conducted an analysis of data from the ongoing Phase 1/1b
ARC-8 trial evaluating quemliclustat plus chemotherapy with or
without zimberelimab in first-line pancreatic cancer.
- At this analysis, patients had a median follow-up time of 22
months, and the overall survival data were mature.
- These data were encouraging relative to historical benchmarks
for chemotherapy alone and will be submitted for presentation at a
future scientific conference.
Etrumadenant (A2a/A2b adenosine
receptor antagonist)
- Arcus and Gilead reviewed radiographic PFS (rPFS) data from the
randomized cohort of ARC-6, a Phase 1b/2 study evaluating
etrumadenant plus zimberelimab and docetaxel versus docetaxel in
metastatic castrate-resistant prostate cancer (mCRPC).
- While the trial will continue to completion, further
development of etrumadenant in mCRPC has been deprioritized.
- Data from ARC-9, a Phase 1b/2 study evaluating etrumadenant
plus zimberelimab plus chemotherapy in second-line and third-line
metastatic colorectal cancer (mCRC), which is fully enrolled, are
expected in the first half of 2024, due to a
slower-than-anticipated event rate.
Early Clinical and Preclinical
Programs
- Arcus initiated ARC-25, a Phase 1 trial in cancer patients for
AB598, its anti-CD39 antibody, in the second quarter of 2023.
- Arcus expects to initiate a Phase 1 study in healthy volunteers
of AB801, its potent and highly selective Axl inhibitor, in the
third quarter of 2023.
- Arcus has identified several chemotypes against KIT, a target
involved in multiple allergic and immune-mediated diseases.
Advanced molecules, with differentiated chemotypes relative to the
previously identified AB375, are undergoing characterization. Arcus
expects to select a new development candidate by year end.
Corporate Highlights:
- In May 2023, Arcus and Gilead expanded their previously
announced research collaboration focused on oncology to include
therapies for the treatment of inflammatory diseases.
- Under the terms of the expanded collaboration, Arcus received
an upfront payment of $35 million and will initiate research
programs against up to four targets jointly selected by the parties
that are applicable to inflammatory diseases.
- Gilead may exercise an option to license each program at two
separate, prespecified time points.
- If Gilead exercises its option at the earlier time point for
the first two target programs, Arcus would be eligible to receive
up to $420 million in option and milestone payments as well as
tiered royalties for each optioned program.
- For any other option exercise by Gilead for the four target
programs, the parties would have rights to co-develop and share
global development costs and to co-commercialize and share profits
in the United States for optioned programs.
- In June 2023, Arcus sold 1.0 million shares of common stock to
Gilead at a purchase price of $19.26 per share, increasing Gilead’s
ownership to 19.9%. Gross proceeds to Arcus from the transaction
were $19.5 million.
Financial Results for Second Quarter 2023:
- Cash, cash equivalents and marketable securities were
$1.0 billion as of June 30, 2023, compared to $1.1 billion as of
December 31, 2022. The decrease during the period is primarily due
to the use of cash in research and development activities,
partially offset by receipts of $35 million in upfront payments
from Gilead to initiate Arcus-led discovery and early development
activities on two jointly selected inflammation targets and $20
million in proceeds from their purchase of 1.0 million shares of
our common stock. Arcus now expects cash utilization between $290
million and $325 million for the year ended December 31, 2023.
Arcus continues to expect cash, cash equivalents and marketable
securities on-hand to be sufficient to fund operations into
2026.
- Revenues were $29 million for the second quarter 2023,
compared to $27 million for the same period in 2022. In the second
quarter 2023, Arcus recognized $19 million in license and
development service revenues related to the advancement of programs
under the Gilead collaboration as well as $10 million in other
collaboration revenue primarily related to Gilead’s ongoing rights
to access Arcus’s research and development pipeline in accordance
with the Gilead collaboration agreement. Revenues were $54 million
for the six months ended June 30, 2023, compared to $45 million for
the same period in 2022.
- Research and Development (R&D) Expenses were $84
million for the second quarter 2023, compared to $70 million for
the same period in 2022. Arcus’s expanding clinical and development
activities increased costs by $19 million, partially offset by $5
million in higher reimbursements for shared expenses from Arcus's
collaborations, primarily the Gilead collaboration. The net
increase was driven primarily by: increases in clinical costs due
to Arcus's expanding clinical and development activities as Arcus
enrolled more patients in its existing and new studies; increases
in net employee compensation costs due to our growing headcount;
partially offset by a decrease in net drug manufacturing costs due
to less manufacturing activity for domvanalimab. Non-cash
stock-based compensation expense was $9 million and $7 million for
the second quarter 2023 and 2022, respectively. R&D expenses
were $165 million for the six months ended June 30, 2023, compared
to $131 million for the same period in 2022. For second-quarter
2023 and 2022, Arcus recognized reimbursements of $44 million and
$39 million, respectively, for shared expenses from its
collaborations, primarily the Gilead collaboration. Reimbursements
were $86 million for the six months ended June 30, 2023, compared
to $70 million for the same period in 2022.
- General and Administrative (G&A) Expenses were $28
million for the second quarter 2023, compared to $26 million for
the same period in 2022. The increase was primarily driven by the
increased complexity of supporting Arcus's expanding clinical
pipeline and partnership obligations. Non-cash stock-based
compensation expense was $9 million for the second quarter 2023,
compared to $8 million for the same period in 2022. G&A
expenses were $58 million for the six months ended June 30, 2023,
compared to $50 million for the same period in 2022.
- Net Loss was $75 million for the second quarter 2023,
compared to $67 million for the same period in 2022. Net loss was
$155 million for the six months ended June 30, 2023, compared to
$135 million for the same period in 2022.
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
(Operationalized by AZ)
dom + durva vs. durva
Curative-Intent Stage 3 NSCLC
Ongoing Registrational Phase
3
NCT05211895
ARC-10
dom + zim vs. pembro
1L NSCLC (PD-L1 ≥ 50%)
Ongoing Registrational Phase
3
NCT04736173
STAR-121
(Operationalized by Gilead)
dom + zim + chemo vs. pembro +
chemo
1L NSCLC (PD-L1 all-comers)
Ongoing Registrational Phase
3
NCT05502237
EDGE-Lung
dom +/- zim +/- quemli +/-
chemo
1L/2L NSCLC (lung cancer platform
study)
Ongoing Randomized Phase 2
NCT05676931
VELOCITY-Lung
(Operationalized by Gilead)
dom +/- zim +/- etruma +/-
sacituzumab govitecan-hziy or other combos
1L/2L NSCLC (lung cancer platform
study)
Ongoing Randomized Phase 2
NCT05633667
Gastrointestinal Cancers
ARC-9
etruma + zim + mFOLFOX vs.
SOC
2L/3L/3L+ CRC
Ongoing
Randomized Phase 2
NCT04660812
EDGE-Gastric (ARC-21)
dom +/- zim +/- quemli +/-
chemo
1L/2L Upper GI Malignancies
Ongoing
Randomized Phase 2
NCT05329766
STAR-221
dom + zim + chemo vs. nivo +
chemo
1L Gastric, Gastroesophageal
Junction (GEJ), and Esophageal Adenocarcinoma (EAC)
Ongoing Registrational Phase
3
NCT05568095
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 (also
enrolling sacituzumab govitecan-hziy combination cohorts)
2L/3L CRPC
Ongoing Randomized Phase 2
NCT04381832
Renal Cancer
ARC-20
AB521
Cancer Patients / ccRCC
Ongoing Phase 1/1b
NCT05536141
Other
ARC-25
AB598
Advanced Malignancies
Ongoing
NCT05891171
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, Arcus entered into a 10-year collaboration with
Gilead to strategically advance our portfolio. Under this
collaboration, Gilead obtained time-limited exclusive option rights
to all of our clinical programs arising during the collaboration
term. We and Gilead are co-developing five investigational
products, including zimberelimab (our anti-PD-1 molecule),
domvanalimab (our anti-TIGIT antibody), etrumadenant (our adenosine
receptor antagonist) and quemliclustat (our CD73 inhibitor). The
collaboration was expanded in November 2021 to include research
directed to two targets for oncology, which research collaboration
was further expanded in May 2023 to add up to four targets for
inflammatory diseases.
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 multiple investigational
medicines into clinical studies, including new combination
approaches that target TIGIT, PD-1, the adenosine axis (CD73 and
dual A2a/A2b receptor) and HIF-2a. For more information about Arcus
Biosciences’ clinical and pre-clinical programs, please visit
www.arcusbio.com or follow us on Twitter.
Domvanalimab, etrumadenant, quemliclustat, and zimberelimab are
investigational molecules, and neither Gilead nor Arcus has
received approval from any regulatory authority for any use
globally, and their safety and efficacy have not been established.
AB521 and AB598 are also investigational molecules, and Arcus has
not received approval from any regulatory authority for any use
globally, and their safety and efficacy have not been
established.
Forward-Looking Statements
This press release contains forward-looking statements. All
statements regarding events or results to occur in the future
contained herein 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, including, but not limited to, the statements in Dr.
Rosen’s quote and statements regarding: Arcus’s expectation that
its cash, cash equivalents and marketable securities on-hand are
sufficient to fund operations into 2026; the timing and scope of
analyses, data disclosures and presentations; the potency, efficacy
or safety of Arcus’s investigational products; and the initiation
of and associated timing for future studies. 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; 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, 2023, filed on August 7, 2023 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
(unaudited)
(In millions, except per share
amounts)
Three Months Ended
Six Months Ended
June 30,
June 30,
2023
2022
2023
2022
Revenues:
License and development service
revenue
$
19
$
17
$
36
$
25
Other collaboration revenue
10
10
18
20
Total revenues
29
27
54
45
Operating expenses:
Research and development
84
70
165
131
General and administrative
28
26
58
50
Total operating expenses
112
96
223
181
Loss from operations
(83
)
(69
)
(169
)
(136
)
Non-operating income (expense):
Interest and other income, net
9
3
18
3
Effective interest on liability for sale
of future royalties
-
(1
)
(1
)
(1
)
Total non-operating income, net
9
2
17
2
Net loss before income taxes
(74
)
(67
)
(152
)
(134
)
Income tax expense
(1
)
-
(3
)
(1
)
Net loss
$
(75
)
$
(67
)
$
(155
)
$
(135
)
Net loss per share:
Basic and diluted
$
(1.04
)
$
(0.93
)
$
(2.13
)
$
(1.88
)
Shares used to compute net loss per
share:
Basic and diluted
73.2
71.8
73.1
71.5
Selected Consolidated Balance
Sheet Data
(unaudited)
(In millions)
June 30,
December 31,
2023
2022(1)
Cash, cash equivalents and
marketable securities
$
1,010
$
1,138
Total assets
1,220
1,345
Total liabilities
654
688
Total stockholders’ equity
566
657
(1) Derived from the audited financial statements for the
quarter ended December 31, 2022, included in the Company's Annual
Report on Form 10-K filed with the Securities and Exchange
Commission on February 28, 2023.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230807838881/en/
Investor Inquiries: Pia Eaves (Banerjee) Head of Investor
Relations & Strategy (617) 459-2006 peaves@arcusbio.com
Media Inquiries: Holli Kolkey VP of Corporate
Communications (650) 922-1269 hkolkey@arcusbio.com
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