- Arcus and Gilead announced an additional equity investment of
$320 million into Arcus and modifications to their domvanalimab +
zimberelimab clinical program to focus on the highest unmet medical
needs and largest market opportunities
- Pharmacokinetic (PK), pharmacodynamic (PD), safety and early
efficacy data, including initial observations from the expansion
cohort, from ARC-20, support potential for casdatifan (AB521) to
result in greater HIF-2a inhibition than the marketed competitor;
expansion cohort data expected to be presented in the second half
of 2024
- Multiple datasets expected to be presented in the first half of
2024 including EDGE-Gastric for domvanalimab + zimberelimab +
chemotherapy at ASCO and two randomized datasets for
etrumadenant
- $1.2 billion in pro forma cash, cash equivalents and marketable
securities and funding into 2027 to support Phase 3 trials for 3
different molecules and launch preparations
- Conference call today at 2:00 PM PT / 5:00 PM ET
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 fourth quarter and full year
ended December 31, 2023, and provided a pipeline update on its
clinical-stage investigational molecules – targeting TIGIT, the
adenosine axis (CD73 and A2a/A2b receptors), HIF-2a, AXL and PD-1 –
across multiple common cancers.
“By the beginning of next year, we expect to have six ongoing
Phase 3 trials for three distinct programs: domvanalimab plus
zimberelimab, our Fc-silent anti-TIGIT antibody and anti-PD-1
antibody combination; casdatifan (AB521), our HIF-2a inhibitor; and
quemliclustat, our CD73 inhibitor. Two of our Phase 3 trials
(STAR-121 and STAR-221) for domvanalimab plus zimberelimab are
expected to complete enrollment this year, and we are beginning
preparations for regulatory filings,” said Terry Rosen, Ph.D.,
chief executive officer of Arcus. “We now have cash runway into
2027, enabling us to accelerate our multiple late-clinical stage
studies and support our highly productive discovery engine.”
Corporate Update:
- In January 2024, Gilead and Arcus announced an amendment to
their collaboration agreement and a separate equity investment,
raising Gilead’s ownership stake to 33%. In connection with the
announcement, Gilead’s Chief Commercial Officer, Johanna Mercier,
joined Arcus’s board.
- In December 2023, Arcus and Exelixis announced a clinical trial
collaboration for STELLAR-009, a Phase 1b/2 trial evaluating
casdatifan in combination with zanzalintinib in patients with
advanced solid tumors, including clear cell renal cell carcinoma
(ccRCC). The trial is currently enrolling.
Pipeline Highlights:
Domvanalimab (Fc-silent anti-TIGIT
monoclonal antibody) plus Zimberelimab (anti-PD-1
antibody)
Domvanalimab-zimberelimab Updates:
- Arcus and Gilead announced strategic changes and enrollment
updates to their domvanalimab + zimberelimab clinical program to
focus on settings with the highest unmet medical need and where the
Fc-silent design of domvanalimab has the potential for
differentiation in both efficacy and safety.
- Enrollment was discontinued for the Phase 3 study ARC-10
evaluating domvanalimab plus zimberelimab compared to pembrolizumab
in first-line PD-L1-high NSCLC. This enables a potential
acceleration of the Phase 3 study STAR-121 in the all-comer
first-line NSCLC setting.
- Arcus and Gilead plan to initiate STAR-131, a registrational
Phase 3 study in perioperative NSCLC.
- The companies also plan to initiate a Phase 2 trial to evaluate
domvanalimab plus zimberelimab in a new disease setting.
Upcoming Domvanalimab-Zimberelimab Milestones:
- Updated PFS and ORR data from the Phase 2 EDGE-Gastric trial
evaluating domvanalimab + zimberelimab + chemotherapy in first-line
upper GI cancers are expected to be presented at the ASCO Annual
Meeting in June 2024. This study is evaluating a similar regimen
and patient population as our STAR-221 phase 3 study.
- Data and insights from previously enrolled patients in the
ARC-10 study (Part 1) are expected to be shared at future
scientific conferences.
- The Phase 3 studies STAR-221 and STAR-121 are expected to
complete enrollment by year-end.
Casdatifan, also known as AB521
(HIF-2a inhibitor)
Casdatifan (AB521) Updates:
- Arcus shared PK, PD, safety, and early efficacy data from the
dose-escalation phase of ARC-20, a Phase 1/1b study of casdatifan
in cancer patients.
- PK, PD, and Safety Data:
- PD data demonstrated that a 20 mg daily dose of casdatifan
(one-fifth the selected Phase 3 dose of 100 mg) achieved a similar
level of HIF-2a-mediated EPO suppression as the 120 mg approved
dose of the marketed competitor, belzutifan.
- Dose-proportional PK were observed through the selected Phase 3
dose of 100 mg of casdatifan. By contrast, plasma levels of
belzutifan do not meaningfully increase above the approved dose of
120 mg.
- Together, the PK and PD profile observed suggests that the
selected dose of 100mg of casdatifan has the potential to achieve
substantially greater HIF-2a inhibition than the approved dose of
belzutifan.
- No dose-limiting toxicities have been observed to date in
ARC-20.
- To date, rates of adverse events, including anemia and hypoxia,
appear consistent with observations from historical trials of
belzutifan.
- Early efficacy data from the dose-escalation and 100 mg
dose-expansion cohorts will be discussed on today’s conference
call.
- Arcus intends to initiate a Phase 3 combination study in ccRCC
in early 2025.
Upcoming Casdatifan (AB521) Milestones:
- Efficacy data from the dose-expansion stage of the ARC-20 study
are expected to be presented at a medical conference in the second
half of 2024.
- The data will focus on the cohort of 30 patients treated with a
100 mg daily dose of casdatifan.
- In addition, a 50 mg daily expansion cohort is currently
enrolling and a to-be-determined higher dose expansion cohort is
planned; data from these cohorts will be shared at a later
date.
Quemliclustat (small-molecule CD73
inhibitor)
- Arcus presented overall survival data at the 2024 ASCO GI
conference from the ongoing Phase 1/1b ARC-8 trial evaluating
quemliclustat plus chemotherapy with or without zimberelimab in
patients with previously untreated metastatic pancreatic ductal
adenocarcinoma (mPDAC).
- Median Overall Survival (mOS) was 15.7 months for all patients
treated with 100 mg quemliclustat-based regimens (pooled analysis)
in the ARC-8 study, which exceeds the historical benchmark data for
chemotherapy alone.
- A 37% reduction in risk of death and a 5.9-month improvement in
mOS was observed for patients treated with quemliclustat-based
regimens when compared to a Synthetic Control Arm of 1:1 matched
patients who were treated with gemcitabine/nab-paclitaxel in Phase
2 and 3 clinical studies in a post hoc analysis.
- Initiation of a Phase 3 trial in pancreatic cancer is expected
to begin by early 2025.
Etrumadenant (A2a/A2b adenosine
receptor antagonist)
- Data from ARC-9, a randomized Phase 1b/2 study evaluating
etrumadenant plus zimberelimab plus chemotherapy versus regorafenib
in third-line metastatic colorectal cancer (mCRC) are expected to
be presented in the first half of 2024.
- Data from MORPHEUS-PDAC, a randomized Phase 2 platform study
operationalized by Roche evaluating etrumadenant plus atezolizumab
plus chemotherapy versus chemotherapy in first-line metastatic
pancreatic ductal adenocarcinoma, are expected to be presented in
the first half of 2024.
Early Clinical and Preclinical
Programs
- Arcus initiated ARC-27, a Phase 1 study of AB801, Arcus’s
potent and highly selective AXL inhibitor, in advanced cancer
patients and expects to initiate the first expansion cohort in
NSCLC in 2025.
- Arcus is conducting preclinical toxicity studies on multiple
development candidates against KIT, a target involved in multiple
allergic and immune-mediated diseases.
Financial Results for Fourth Quarter and Full Year
2023:
- Cash, Cash Equivalents and Marketable Securities were
$866 million as of December 31, 2023, compared to $1.1 billion as
of December 31, 2022. The decrease during the year is primarily due
to the use of cash in research and development activities,
partially offset by receipts totaling $49 million in upfront and
milestone payments from Gilead and Taiho, and $33 million in
proceeds from the issuance of 2.6 million shares of our common
stock including shares pursuant to an equity award plan. Together
with the $320 million we received from Gilead for their equity
investment in January 2024, our cash, cash equivalents and
marketable securities were $1.2 billion, which we believe will be
sufficient to fund our planned operations into 2027. Cash, cash
equivalents and marketable securities are expected to be between
$870 and $920 million at the end of 2024.
- Revenues were $31 million for the fourth quarter 2023,
compared to $34 million for the same period in 2022. In the fourth
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 $9 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 $117 million for the full year 2023, compared to $112 million
for the same period in 2022.
- Research and Development (R&D) Expenses were $93
million for the fourth quarter 2023, compared to $80 million for
the same period in 2022. The net increase of $13 million was
primarily driven by higher costs to support our late-stage
development program activities. Non-cash stock-based compensation
expense was $9 million for each of the fourth quarter 2023 and
2022. R&D expenses were $340 million for the full year 2023,
compared to $288 million for the same period in 2022. For fourth
quarter 2023 and 2022, Arcus recognized gross reimbursements of $42
million and $49 million, respectively, for shared expenses from its
collaborations, primarily the Gilead collaboration. Gross
reimbursements were $162 million for the full year 2023, compared
to $161 million for 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 $29
million for the fourth quarter 2023, compared to $28 million for
the same period in 2022. Non-cash stock-based compensation expense
was $9 million for the fourth quarter 2023, compared to $8 million
for the same period in 2022. G&A expenses were $117 million for
the full year 2023, compared to $104 million for 2022.
- Net Loss was $81 million for the fourth quarter 2023,
compared to $67 million for the same period in 2022. The increase
in net loss included an increase of $1 million in income tax
expense primarily due to an increase in taxable income compared to
the prior year. Net loss was $307 million for the full year 2023,
compared to $267 million for 2022.
Conference Call Information:
Arcus will host a conference call and webcast today, February
21, at 2:00 PM PT / 5:00 PM ET to discuss its fourth-quarter and
full-year 2023 financial results and pipeline updates. To access
the call, please dial (404) 975-4839 (local) or (833) 470-1428
(toll-free), using Access Code: 235272. To access the live webcast
and accompanying slide presentation, please visit the “Investors
& Media” section of the Arcus Biosciences website at
www.arcusbio.com. A replay of the webcast will be available
following the live event.
Arcus Ongoing and Announced Clinical Studies:
Trial Name
Arms
Setting
Status
NCT No.
Lung Cancer
PACIFIC-8
dom + durva vs. durva
Unresectable Stage 3 NSCLC
Ongoing Registrational Phase 3
NCT05211895
STAR-121
dom + zim + chemo vs. pembro + chemo
1L NSCLC (PD-L1 all-comers)
Ongoing Registrational Phase 3
NCT05502237
STAR-131
dom + zim + chemo; dom + zim
Perioperative NSCLC
Planned Registrational Phase 3
TBD
EDGE-Lung
dom +/- zim +/- quemli +/- chemo
1L/2L NSCLC (lung cancer platform
study)
Ongoing Randomized Phase 2
NCT05676931
VELOCITY-Lung
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
Kidney Cancer
ARC-20
cas
Cancer Patients / ccRCC
Ongoing Phase 1/1b
NCT05536141
STELLAR-009
cas + zanza
ccRCC
Ongoing Phase 1b/2
NCT06191796
Other
ARC-25
AB598
Advanced Malignancies
Ongoing
NCT05891171
ARC-26
AB801
Healthy Volunteers
Ongoing
NCT06004921
ARC-27
AB801
Advanced Malignancies
Ongoing
NCT06120075
cas: casdatifan; dom: domvanalimab; durva: durvalumab; etruma:
etrumadenant; gem/nab-pac: gemcitabine/nab-paclitaxel; nivo:
nivolumab; pembro: pembrolizumab; quemli: quemliclustat; SOC:
standard of care; zanza: zanzalintinib; 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 four 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, dual
A2a/A2b receptor and CD39), AXL 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.
Casdatifan, AB598 and AB801 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 2027 and support Phase 3 trials
for 3 different molecules and launch preparations; the timing and
scope of analyses, data disclosures and presentations; whether data
and results from current studies support further development of a
program; expected timing of clinical milestones, including the
completion of enrollment; our ability to accelerate the development
of our clinical pipeline; the potential of casdatifan to achieve
substantially greater HIF-2a inhibition than the approved dose of
the marketed competitor; the potency, efficacy or safety of Arcus’s
investigational products; and the initiation of and associated
timing for future studies, including STAR-131 and the Phase 3
studies in ccRCC and pancreatic cancer. 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 periodic report 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
December 31,
Years Ended December
31,
2023
2022
2023
2022
Revenues:
License and development service
revenue
$
22
$
26
$
80
$
74
Other collaboration revenue
9
8
37
38
Total revenues
31
34
117
112
Operating expenses:
Research and development
93
80
340
288
General and administrative
29
28
117
104
Total operating expenses
122
108
457
392
Loss from operations
(91
)
(74
)
(340
)
(280
)
Non-operating income (expense):
Interest and other income, net
11
8
41
16
Effective interest on liability for sale
of future royalties
—
(1
)
(2
)
(2
)
Total non-operating income, net
11
7
39
14
Net loss before income taxes
(80
)
(67
)
(301
)
(266
)
Income tax expense
(1
)
—
(6
)
(1
)
Net loss
$
(81
)
$
(67
)
$
(307
)
$
(267
)
Net loss per share:
Basic and diluted
$
(1.08
)
$
(0.93
)
$
(4.15
)
$
(3.71
)
Shares used to compute net loss per
share:
Basic and diluted
75.0
72.6
74.0
72.0
Selected Consolidated Balance
Sheet Data
(unaudited)
(In millions)
December 31,
2023
December 31,
2022
Cash, cash equivalents and marketable
securities
$
866
$
1,138
Total assets
1,095
1,345
Total liabilities
633
688
Total stockholders’ equity
462
657
Derived from the audited financial
statements included in the Company's Annual Report on Form 10-K
filed with the Securities and Exchange Commission on February 21,
2024.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240221004993/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
Arcus Biosciences (NYSE:RCUS)
Historical Stock Chart
From Apr 2024 to May 2024
Arcus Biosciences (NYSE:RCUS)
Historical Stock Chart
From May 2023 to May 2024