- Selected 150 mg for the dose expansion trial
for AB928, the Company’s dual A2a/A2b receptor antagonist, in
combination with AB122, the Company’s anti-PD-1 antibody
- Ended the first quarter 2019 with $243.1
million in cash and investments, which the Company continues to
expect will fund operations into 2021
Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage
biopharmaceutical company focused on creating innovative cancer
immunotherapies, today announced financial results for the first
quarter 2019. The Company also provided updates on its clinical
programs.
“In the first quarter of 2019, we advanced our lead molecule
AB928, a potential best-in-class dual A2a/A2b receptor antagonist,
specifically designed for oncology indications, by selecting 150 mg
for dose expansion studies in combination with AB122, the Company’s
anti-PD-1 antibody. The Company also began enrollment in the fourth
combination dose-escalation trial evaluating AB928 in non-small
cell lung carcinoma patients,” said Terry Rosen, Ph.D., Chief
Executive Officer of Arcus. “Operationally, we recently rounded out
our management team with two key additions, Rekha Hemrajani as
Chief Operating and Financial Officer and Dr. Bill Grossman as
Chief Medical Officer. Both bring extensive expertise from the
biotechnology and cancer immunotherapy spaces. Together, we are
eager to work towards translating our unique science into
life-changing therapies for patients.”
Pipeline Updates
AB928 (dual A2aR/A2bR
antagonist)
- Selected 150 mg for the dose-expansion
portion of the trial of AB928 in combination with its anti-PD-1
antibody AB122 in advanced solid tumors.
- Continued to enroll patients in these
combination dose-escalation trials of AB928 in combination with
chemotherapy:
- AB928 in combination with Doxil® in
triple negative breast cancer (TNBC) and ovarian cancer.
- AB928 in combination with mFOLFOX in
colorectal cancer and gastroesophageal cancer.
- Began enrolling the fourth AB928
combination dose-escalation trial:
- AB928 in combination with
carboplatin/pemetrexed and pembrolizumab in non-small cell lung
cancer (NSCLC) after failing tyrosine kinase inhibitor (TKI)
therapy.
AB680 (small-molecule CD73 inhibitor)
- Continued to dose patients in the
healthy volunteer trial of AB680 (i.v. formulation) in Australia.
This trial is primarily designed to determine the safety,
tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profile
of AB680 prior to initiating clinical testing of AB680 in cancer
patients.
- Continued to progress IND-enabling
studies for an oral formulation of AB680.
AB122 (anti-PD-1 antibody)
- Continued to enroll patients in the
Phase 1 dose-escalation trial for AB122. Based on data generated to
date, the Company selected 240 mg as the dose for the Q2W (every 2
weeks) regimen for AB122. The Company continues to evaluate
alternative doses and dosing schedules.
AB154 (anti-TIGIT antibody)
- Continued to enroll patients in the
dose-escalation portion of the ongoing Phase 1 trial for AB154 in
Australia, which is evaluating AB154 as a monotherapy and in
combination with AB122 in advanced solid tumors. The
dose-escalation portion will be followed by the initiation of
dose-expansion cohorts in solid tumors associated with high levels
of TIGIT and/or CD155, the primary ligand for TIGIT, once the
recommended doses for AB154 as a monotherapy and in combination
with AB122 have been identified.
Recent Corporate Updates
- In March 2019, Arcus announced the
appointment of Rekha Hemrajani to Chief Operating and Financial
Officer following the transition of Jennifer Jarrett, the Company’s
former Chief Operating and Financial Officer.
- In May 2019, Arcus announced the
appointment of William Grossman, M.D., Ph.D., to Chief Medical
Officer.
- In May 2019, Arcus entered into a
clinical development collaboration with Strata Oncology utilizing
Strata’s precision drug development platform and proprietary
biomarkers to evaluate AB122 in a basket trial including tumor
types that are generally not responsive to anti-PD-1 therapy.
Upcoming Clinical
Presentations
- Arcus to present a poster on
preliminary results from the ongoing Phase 1 studies of AB928 in
combination with chemotherapy or AB122 in patients with advanced
tumors at the 2019 American Society of Clinical Oncology (ASCO)
Annual Meeting on June 1, 2019 in Chicago, IL.
- Arcus to host an investor and analyst
call at the end of June to provide an update on its clinical
programs.
Upcoming Milestones
By the end of the second quarter 2019, the Company expects
to:
- Present initial safety, PK/PD profile,
biomarker analysis and clinical activity data from the
dose-escalation portion of the AB928 combination trials.
- Initiate a dose-expansion study for
AB928 in combination with AB122 in patients with renal cell cancer
(RCC).
In the second half of 2019, the Company expects to:
- Present additional data from the
dose-escalation portion of the AB928 combination trials.
- Initiate a dose-expansion study for
AB928 in combination with AB122 in patients with metastatic
castration-resistant prostate cancer (mCRPC).
- Report initial safety, tolerability and
PK/PD data from the Phase 1 trial of AB680 in healthy
volunteers.
- Initiate a Phase 1 trial for AB680 in
patients with advanced solid tumors.
- Report initial data on the safety,
tolerability, PK/PD and clinical activity of AB154 as monotherapy
and in combination with AB122.
- Initiate a basket trial to evaluate
AB122 in molecularly defined patient populations, that are
generally not responsive to anti-PD-1 therapy, utilizing the Strata
Precision Oncology Network and proprietary biomarkers.
Financial Results for the First Quarter
2019
- Cash, cash equivalents and both
short-term and long-term investments were $243.1 million as of
the first quarter ended March 31, 2019, compared to $259.7 million
at December 31, 2018. The decrease was primarily due to the
utilization of cash to fund our operations.
- Revenues: Collaboration and
license revenues for the first quarter ended March 31, 2019 were
$1.8 million, compared to $1.3 million for the same period in 2018.
The increase in revenue was primarily attributable to the adoption
of Accounting Standards Codification Topic 606, Revenue from
Contracts with Customers (ASC 606). Under ASC 606, additional
revenue was recognized as a result of a higher initial transaction
price from the Option and License Agreement, which the Company
entered into with Taiho Pharmaceutical Co., Ltd in September
2017.
- R&D Expenses: Research and
development expenses for the first quarter ended March 31, 2019
were $15.6 million, compared to $11.7 million for the same period
in 2018. The increase in research and development expenses was
primarily due to an increase in clinical activities for our four
ongoing clinical programs and increase in headcount, which was
partially offset due to a decrease in manufacturing costs.
- G&A Expenses: General and
administrative expenses for the first quarter ended March 31, 2019
were $5.0 million, compared to $2.9 million for the same period in
2018. Higher general and administrative expenses were primarily due
to an increase in headcount and related costs, as well as costs
related to activities as a public company.
- Net Loss: Net loss for the first
quarter ended March 31, 2019 was $17.7 million, compared to $13.0
million for the same period in 2018. The increase in net loss was
primarily attributable to changes in operating expenses noted above
offset by the increase in revenues and an increase in interest
income.
Based on its current operating plan, the Company expects that
its cash and investments as of March 31, 2019 will enable the
Company to fund its anticipated operating expenses and capital
expenditure requirements into 2021.
About Arcus Biosciences
Arcus Biosciences is a clinical-stage biopharmaceutical company
focused on creating innovative cancer immunotherapies. Arcus
has several programs targeting important immuno-oncology pathways,
including a dual adenosine receptor antagonist, AB928, which is in
a Phase 1/1b program to evaluate AB928 in combination with other
agents in multiple tumor types, and an anti-PD-1 antibody, AB122,
which is being evaluated in a Phase 1 trial and is being tested in
combination with Arcus’s other product candidates. Arcus’s other
programs include AB154, an anti-TIGIT antibody, which is being
evaluated in a Phase 1 trial as monotherapy and in combination with
AB122, and AB680, a small-molecule inhibitor of CD73, which is in a
Phase 1 healthy volunteer study. Arcus has extensive in-house
expertise in medicinal chemistry, immunology, biochemistry,
pharmacology and structural biology. For more information about
Arcus Biosciences, please visit www.arcusbio.com.
Forward-Looking Statements
This press release contains forward-looking statements. All
statements other than statements of historical facts contained
herein, including, but not limited to, Arcus’s expectations
regarding the advancement and potential of its clinical development
programs, milestones, timelines, and anticipated operating expenses
and capital expenditure requirements, 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,
uncertainties and other important factors that may cause Arcus’s
actual results, performance or achievements to differ significantly
from those expressed or implied. Factors that could cause or
contribute to such differences include, but are not limited to, the
inherent uncertainty associated with pharmaceutical product
development and clinical trials, difficulties or delays in
developing and validating biomarkers and related assays, 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, the emergence of adverse events or other
undesirable side effects, and changes in the competitive landscape
for our programs. Risks and uncertainties facing Arcus are
described more fully in Arcus’s quarterly report on Form 10-Q for
the quarter ended March 31, 2019 filed on May 2, 2019 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.
Doxil® is a registered trademark of Alza Corporation.
ARCUS BIOSCIENCES, INC. Condensed Consolidated
Balance Sheets (In thousands, except share and per share
amounts) (unaudited) March 31,
December 31,
2019
2018(1)
ASSETS Current assets: Cash and cash equivalents $ 68,499 $
71,064 Short-term investments 173,436 185,480 Prepaid expenses and
other current assets 3,080 2,321 Amounts owed by a related party
- 83 Total current assets 245,015
258,948 Long-term investments 1,201 3,181 Property and equipment,
net 11,026 11,107 Equity investment in related party 770 1,202
Restricted cash 203 203 Other long-term assets 315
284 Total assets $ 258,530 $ 274,925
LIABILITIES Current liabilities Accounts payable $ 2,829 $
3,102 Accrued liabilities 7,629 6,023 Deferred revenue, current
7,000 6,250 Other current liabilities 1,545
1,560 Total current liabilities 19,003
16,935 Deferred revenue, noncurrent 12,272 16,984 Deferred
rent 4,145 4,272 Other long-term liabilities 1,543
1,792 Total liabilities 36,963
39,983 Stockholders’ equity: Common stock 4 4 Additional
paid-in capital 359,820 357,873 Accumulated deficit (138,286 )
(122,828 ) Accumulated other comprehensive income (loss) 29
(107 ) Total stockholders’ equity 221,567
234,942 Total liabilities, convertible
preferred stock and stockholders’ equity $ 258,530 $ 274,925
(1) Derived from the audited financial statements for
the year ended December 31, 2018, included in the Company's Annual
Report on Form 10-K filed with the Securities and Exchange
Commission, dated March 5, 2019.
ARCUS BIOSCIENCES,
INC. Condensed Consolidated Statements of Operations and
Comprehensive Loss (In thousands, except share and per share
amounts) (unaudited)
Three Months Ended March 31, 2019 2018
Collaboration and license revenue $ 1,750 $ 1,250 Operation
expenses: Research and development 15,554 11,652 General and
administrative 4,969 2,929 Total
operating expenses 20,523 14,581 Loss
from operations (18,773 ) (13,331 ) Non-operating income (expense):
Interest and other income (expense), net 1,534 603 Share of loss
from equity method investee (431 ) (226 ) Total
non-operating income, net 1,103 377 Net
loss (17,670 ) (12,954 ) Other comprehensive income
(loss) 136 (55 ) Comprehensive loss $ (17,534 ) $ (13,009 ) Net
loss per share, basic and diluted $ (0.41 ) $ (1.37 )
Weighted-average number of shares used to
compute basic and diluted net loss per share
43,508,592 9,488,352
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version on businesswire.com: https://www.businesswire.com/news/home/20190502005279/en/
Katherine Bock(415) 533-5670kbock@arcusbio.com
Nicole Arndt(510) 284-4728narndt@arcusbio.com
Arcus Biosciences (NYSE:RCUS)
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