- Data were presented from the ongoing EDGE-Gastric Phase 2 study
in first-line upper GI cancers at the Annual Meeting of the
American Society of Clinical Oncology (ASCO) Plenary Series;
domvanalimab is the only Fc-silent anti-TIGIT antibody in Phase 3
for upper GI adenocarcinomas and has the potential to be
first-to-market for these cancers.
- Pharmacokinetic and pharmacodynamic data from the
dose-escalation phase of ARC-20, a Phase 1b study in cancer
patients of AB521, a potential best-in-class HIF-2a inhibitor, are
consistent with results seen in healthy volunteers; more details,
including preliminary signs of efficacy, are expected in early
2024.
- An analysis of efficacy and safety data from the Phase 1/1b
ARC-8 study of quemliclustat in advanced pancreatic cancer will be
presented in early 2024.
- With $950 million in cash, cash equivalents and marketable
securities and funding expected 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 third quarter ended September
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.
“As we continue to execute on our Phase 3 trials for
domvanalimab in lung and GI cancers, we have one of three important
near-term data readouts now behind us. Today’s presentation of data
from our Phase 2 EDGE-Gastric study provided important evidence to
support domvanalimab’s potential as a differentiated and
first-to-market anti-TIGIT antibody for the treatment of first-line
upper GI adenocarcinomas. We are also looking forward to sharing
more on our HIF-2a inhibitor, AB521, which continues to show a
potentially improved clinical profile, with PK/PD results in
patients consistent with those seen in healthy volunteers,” said
Terry Rosen, Ph.D., chief executive officer of Arcus. “Lastly, we
will be presenting mature OS data from our Phase 1/1b study of
quemliclustat in pancreatic cancer early next year; we are excited
to share next steps in the coming months.”
Pipeline Highlights:
Domvanalimab (Fc-silent anti-TIGIT
monoclonal antibody)
- Preliminary data from Arm A1 of the Phase 2 EDGE-Gastric study,
evaluating domvanalimab plus zimberelimab and chemotherapy in
patients with previously untreated, locally advanced unresectable
or metastatic upper gastrointestinal (GI) cancers, were presented
during the Annual Meeting of the American Society of Clinical
Oncology (ASCO) Plenary Series on November 7, 2023. These data were
from the cohort that includes a patient population and dosing
regimen similar to the ongoing Phase 3 study, STAR-221.
- Domvanalimab plus zimberelimab and
chemotherapy showed encouraging objective response rates (ORR) of
80% (confirmed ORR (cORR) of 73%) in patients with PD-L1-high
tumors (TAP ≥5%), 46% (all confirmed) in patients with PD-L1-low
tumors (TAP <5%) and 59% (cORR of 56%) for patients
overall.
- Six-month landmark progression-free survival
(PFS) was 93% for patients with PD-L1-high tumors (TAP ≥5%), 68%
for patients with PD-L1-low tumors (TAP <5%) and 77% for
patients overall.
- Mature PFS has not been reached and data are
expected in the second half of 2024.
- Domvanalimab plus zimberelimab and
chemotherapy was well tolerated, with a similar safety profile to
what has been reported for anti-PD-1 plus chemotherapy in this
setting.
- Domvanalimab is the only Fc-silent anti-TIGIT
antibody in Phase 3 for gastric, gastroesophageal junction and
esophageal adenocarcinoma and has the potential to be first to
market for these cancers. 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)
- Pharmacokinetic (PK) and pharmacodynamic (PD) data from the
dose-escalation phase of ARC-20, a Phase 1/1b study of AB521 in
cancer patients, are consistent with the results seen in healthy
volunteers to date.
- No dose-limiting toxicities have been observed to date in
ARC-20.
- Detailed PK, PD and safety data along with preliminary
anti-tumor activity from this stage of ARC-20 will be shared in
early 2024.
- Enrollment for the dose-expansion stage of ARC-20 in clear cell
renal cell carcinoma (ccRCC) patients is near completion. Efficacy
data from this stage of the ARC-20 study are expected later in
2024. The dose-expansion stage will include 30 patients on a 100-mg
daily dose, which Arcus believes has the potential to achieve
substantially greater HIF-2a inhibition than the approved dose of
the marketed competitor.
- A Phase 2 study evaluating AB521 in combination with a tyrosine
kinase inhibitor (TKI) is anticipated to begin in the fourth
quarter of 2023.
Quemliclustat (small-molecule CD73
inhibitor)
- Arcus conducted an analysis of mature OS data (minimum
follow-up of 18 months) 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, 122 patients in the study had received the
go-forward dose of 100 mg of quemliclustat; median follow-up time
was 21 months.
- These data will be presented in early 2024.
Etrumadenant (A2a/A2b adenosine
receptor antagonist)
- 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.
Early Clinical and Preclinical
Programs
- ARC-25, a Phase 1 trial in cancer patients for AB598, an
anti-CD39 antibody, is currently enrolling.
- Arcus initiated a Phase 1 study in healthy volunteers of AB801,
its potent and highly selective AXL inhibitor, and expects to
initiate a Phase 1 study in advanced cancer patients in the first
quarter of 2024.
- Arcus expects to select a new development candidate against
KIT, a target involved in multiple allergic and immune-mediated
diseases, by year end.
Financial Results for Third Quarter 2023:
- Cash, Cash Equivalents and Marketable Securities were
$950 million as of September 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 $25
million in proceeds from the issuance of 1.2 million shares of our
common stock. Arcus now expects cash utilization between $265
million and $290 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 $32 million for the third quarter 2023,
compared to $33 million for the same period in 2022. In the third
quarter 2023, Arcus recognized $22 million in license and
development service revenues related to the advancement of
programs, primarily 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 $86 million for the nine months ended September 30,
2023, compared to $78 million for the same period in 2022.
- Research and Development (R&D) Expenses were $82
million for the third quarter 2023, compared to $77 million for the
same period in 2022. The net increase of $5 million was primarily
driven by: $7 million of higher spend for Arcus programs not under
a cost-sharing collaboration due to our expanding clinical and
development activities; partially offset by a net decrease of $2
million in shared costs for programs optioned by our collaboration
partners, primarily from the Gilead collaboration. The net decrease
of $2 million was due to a decrease in shared collaboration costs
of $10 million primarily from the timing of clinical manufacturing;
with a corresponding decrease in reimbursements for shared expenses
of $8 million. Non-cash stock-based compensation expense was $8
million for each of the third quarter 2023 and 2022. R&D
expenses were $247 million for the nine months ended September 30,
2023, compared to $208 million for the same period in 2022. For
third quarter 2023 and 2022, Arcus recognized reimbursements of $33
million and $41 million, respectively, for shared expenses from its
collaborations, primarily the Gilead collaboration. Reimbursements
were $119 million for the nine months ended September 30, 2023,
compared to $111 million for the same period in 2022. R&D
expense by quarter may fluctuate due to the timing of clinical
manufacturing and standard-of-care therapeutic purchases with a
corresponding impact on reimbursements.
- General and Administrative (G&A) Expenses were $30
million for the third 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 $10 million for the third quarter 2023,
compared to $8 million for the same period in 2022. G&A
expenses were $88 million for the nine months ended September 30,
2023, compared to $76 million for the same period in 2022.
- Net Loss was $71 million for the third quarter 2023,
compared to $65 million for the same period in 2022. The increase
in net loss included an increase of $2 million in income tax
expense primarily due to an increase in taxable income compared to
the prior year. Net loss was $226 million for the nine months ended
September 30, 2023, compared to $200 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
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
ARC-26
AB801
Healthy Volunteers
Ongoing
NCT06004921
ARC-27
AB801
Advanced Malignancies
Planned
NCT06120075
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 established 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. Arcus and Gilead are co-developing five investigational
products, including zimberelimab (Arcus’s anti-PD-1 molecule),
domvanalimab (Arcus’s anti-TIGIT antibody), etrumadenant (Arcus’s
adenosine receptor antagonist) and quemliclustat (Arcus’s 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; whether data and
results from current studies support further development of a
program; whether any of Arcus’s investigational products will be
first-to-market in a given indication; the potential drug-treatable
population of any indications being pursued by Arcus’s programs;
the potential of AB521 to achieve substantially greater HIF-2a
inhibition than the approved dose of the marketed competitor;
selection of new development candidates, including the timeline for
making a selection; 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 the “Risk Factors” section of Arcus’s most recent
Quarterly Report on Form 10Q filed with the U.S. Securities and
Exchange Commission. 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
September 30,
Nine Months Ended
September 30,
2023
2022
2023
2022
Revenues:
License and development service
revenue
$
22
$
23
$
58
$
48
Other collaboration revenue
10
10
28
30
Total revenues
32
33
86
78
Operating expenses:
Research and development
82
77
247
208
General and administrative
30
26
88
76
Total operating expenses
112
103
335
284
Loss from operations
(80
)
(70
)
(249
)
(206
)
Non-operating income (expense):
Interest and other income, net
12
5
30
8
Effective interest on liability for sale
of future royalties
(1
)
—
(2
)
(1
)
Total non-operating income, net
11
5
28
7
Net loss before income taxes
(69
)
(65
)
(221
)
(199
)
Income tax expense
(2
)
—
(5
)
(1
)
Net loss
$
(71
)
$
(65
)
$
(226
)
$
(200
)
Net loss per share:
Basic and diluted
$
(0.94
)
$
(0.90
)
$
(3.07
)
$
(2.78
)
Shares used to compute net loss per
share:
Basic and diluted
74.6
72.2
73.6
71.8
Selected Consolidated Balance
Sheet Data
(unaudited)
(In millions)
September 30,
2023
December 31,
2022
Cash, cash equivalents and marketable
securities
$
950
$
1,138
Total assets
1,191
1,345
Total liabilities
671
688
Total stockholders’ equity
520
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/20231107114408/en/
Investor Inquiries: Pia Eaves 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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