- Ended 2018 with four molecules in clinical
development, including AB928, the Company’s dual A2aR/A2bR receptor
antagonist, which is being evaluated in several dose-escalation
trials in combination with chemotherapy or AB122 (anti-PD-1
antibody)
- Also ongoing are a Phase 1 trial of AB154
(anti-TIGIT antibody) in patients with advanced solid tumors, alone
and in combination with AB122, as well as a trial of AB680 (CD73
inhibitor) in healthy volunteers
- Ended 2018 with $259.7 million in cash and
investments
Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage
biopharmaceutical company focused on creating innovative cancer
immunotherapies, today announced financial results for the fourth
quarter and full year 2018. The Company also provided updates on
its clinical programs.
“Throughout 2018, we made substantial progress on multiple
programs, ending the year with four product candidates in the
clinic,” said Terry Rosen, Ph.D., Chief Executive Officer at Arcus.
“Enrollment continues in our first three dose-escalation trials for
AB928, in which we are evaluating AB928 in combination with either
immunogenic chemotherapies or our anti-PD-1 antibody, AB122, across
a number of tumor types. We plan to present early data on safety,
pharmacokinetic/pharmacodynamic profile, biomarker analysis and
clinical activity for the AB928 combinations in mid-2019. Following
our IPO last year, we have a strong balance sheet, and we are
well-positioned to execute on our research and clinical development
plans into 2021.”
Pipeline Updates
AB928 (dual A2aR/A2bR
antagonist)
- The Company continues to enroll
patients in the first three AB928 combination trials:
- 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
- AB928 in combination with AB122 in
advanced solid tumors.
- The Company expects to initiate its
fourth AB928 combination trial in patients in the coming months:
- AB928 in combination with
carboplatin/pemetrexed with or without pembrolizumab in non-small
cell lung cancer (NSCLC) after failing tyrosine kinase inhibitor
(TKI) therapy.
AB122 (anti-PD-1 antibody)
- The Company is enrolling the final
cohort of 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 different doses and dosing schedules.
AB154 (anti-TIGIT antibody)
- Enrollment continues 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.
- The Company received clearance from the
FDA of its Investigational New Drug (IND) application for AB154,
which enables incorporation of U.S. sites in the ongoing Phase 1
trial.
AB680 (small-molecule CD73 inhibitor)
- Continued dosing in the healthy
volunteer trial of AB680 (i.v. formulation) in Australia. This
trial is primarily designed to determine the safety, tolerability,
pharmacokinetic and pharmacodynamic profile of AB680 prior to
initiating clinical testing of AB680 in cancer patients.
- IND-enabling studies for an oral
formulation of AB680 have continued to progress.
Corporate Updates
- In January 2019, Arcus announced the
transition and appointment of Jennifer Jarrett to its Board of
Directors. Ms. Jarrett currently serves as Vice President,
Corporate Development and Capital Markets at Uber.
Upcoming Milestones
In mid-2019, the Company expects to:
- Present initial data from the
dose-escalation portion of the AB928 combination trials, which will
include data on safety, pharmacokinetic/pharmacodynamic profile,
biomarker analysis and clinical activity for the combinations.
- Initiate the first of the
dose-expansion cohorts for the AB928 combination trials.
- Initiate a dose-expansion cohort to
evaluate AB122 as a monotherapy to confirm that the activity of
AB122 is similar to that of the approved anti-PD-1 antibodies.
- Report safety, tolerability,
pharmacokinetic and pharmacodynamic data from the Phase 1 trial of
AB680 in healthy volunteers.
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 Phase 1 trial for AB680 in
patients with advanced solid tumors.
- Report initial data on the safety,
tolerability, pharmacokinetic, pharmacodynamic and clinical
activity of AB154 as monotherapy and in combination with
AB122.
Fourth Quarter and Full Year 2018
Financial Results
- Cash Position: At December 31,
2018, cash and investments (which include cash equivalents and both
short-term and long-term investments) were $259.7 million, compared
to $175.7 million at December 31, 2017. The increase was primarily
due to $124.7 million in net proceeds from the Company’s initial
public offering in March, offset by cash utilized to support its
operations in 2018.
- Revenues: Collaboration and
license revenues for the fourth quarter ended December 31, 2018
were $1.6 million, compared to $1.3 million for the same period in
2017. For the full year 2018, collaboration and license revenues
were $8.4 million, compared to $1.4 million for the same period in
2017. The increase in revenues for both periods was attributable to
revenues recognized from the Option and License Agreement into
which the Company entered with Taiho Pharmaceutical Co., Ltd in
September 2017.
- R&D Expenses: Research and
development expenses for the fourth quarter ended December 31, 2018
were $11.4 million, compared to $12.1 million for the same period
in 2017. The decrease was due to licensing milestone costs of $3.8
million paid to WuXi Biologics and Abmuno Therapeutics in the
fourth quarter ended December 31, 2017, which were offset by
increased clinical and manufacturing costs related to the Company’s
four clinical-stage development programs, increased R&D
headcount to support the Company’s clinical operations and other
programs, and an increase in stock-based compensation expense. For
the full year 2018, research and development expenses were $49.6
million, compared to $47.2 million for the same period in
2017.
- G&A Expenses: General and
administrative expenses for the fourth quarter ended December 31,
2018 were $3.6 million, compared to $2.4 million for the same
period in 2017. The increase was primarily due to higher legal and
accounting fees and additional staff in key areas required to
support a public company infrastructure, higher stock-based
compensation expense, as well as increased facilities and office
expenses related to our expanded facility in Hayward. For the full
year 2018, general and administrative expenses were $13.6 million,
compared to $7.6 million for the same period of 2017.
- Net Loss: Net loss for the
fourth quarter ended December 31, 2018 was $12.3 million, compared
to $13.2 million for the same period in 2017. The decrease in net
loss was primarily attributable to the increase in revenue and
changes in operating expenses noted above as well as an increase in
interest income. For the full year 2018, net loss was $49.6
million, compared to $53.1 million for the same period in
2017.
Based on its current operating plan, the Company expects that
its cash and investments as of December 31, 2018 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 clinical
development plans, biomarker activities, milestones and 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, and the emergence of adverse events or
other undesirable side effects. Risks and uncertainties facing
Arcus are described more fully in Arcus’s Annual Report on Form
10-K for the year ended December 31, 2018 filed on March 5, 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. Consolidated Balance
Sheets (In thousands, except share and per share
amounts) December
31,2018 December 31,2017 ASSETS
Current assets: Cash and cash equivalents $ 71,064 $ 98,426
Short-term investments 185,480 77,277 Prepaid expenses and other
current assets 2,321 1,141 Amounts owed by a related party
83 25 Total current assets 258,948 176,869
Long-term investments 3,181 — Property and equipment, net 11,107
11,230 Equity investment in related party 1,202 682 Restricted cash
203 203 Other long-term assets 284 1,502
Total assets $ 274,925 $ 190,486
LIABILITIES Current liabilities Accounts payable $ 3,102 $
3,820 Accrued liabilities 6,023 3,137 Deferred revenue, current
6,250 5,000 Other current liabilities 1,560
769 Total current liabilities 16,935
12,726 Deferred revenue, noncurrent 16,984 18,587 Deferred
rent 4,272 4,740 Other long-term liabilities 1,792
565 Total liabilities 39,983
36,618 Convertible preferred stock — 226,196 Stockholders’
equity (deficit): Common stock 4 — Additional paid-in capital
357,873 948 Accumulated deficit (122,828 ) (73,234 ) Accumulated
other comprehensive loss (107 ) (42 ) Total
stockholders’ equity (deficit) 234,942 (72,328
) Total liabilities, convertible preferred stock and stockholders’
equity $ 274,925 $ 190,486
ARCUS
BIOSCIENCES, INC. Consolidated Statements of Operations and
Comprehensive Loss (In thousands, except share and per share
amounts) (unaudited)
Three Months Ended December 31, Years Ended
December 31, 2018 2017 2018
2017 Collaboration and license revenue $ 1,562 $ 1,250 $
8,353 $ 1,413 Operation expenses: Research and development 11,436
12,146 49,646 47,218 General and administrative 3,610
2,448 13,566 7,636 Total
operating expenses 15,046 14,594
63,212 54,854 Loss from operations (13,484 )
(13,344 ) (54,859 ) (53,441 ) Non-operating income (expense):
Interest and other income (expense), net 1,512 290 4,922 775 Gain
on deemed sale from equity method investee — — 1,229 — Share of
loss from equity method investee (323 ) (156 )
(886 ) (416 ) Total non-operating income, net 1,189
134 5,265 359 Net
loss (12,295 ) (13,210 ) (49,594 )
(53,082 ) Other comprehensive loss 1 (32 ) (65 ) (16 )
Comprehensive loss $ (12,294 ) $ (13,242 ) $ (49,659 ) $ (53,098 )
Net loss per share, basic and diluted $ (0.28 ) $ (5.98 ) $ (1.43 )
$ (29.03 )
Weighted-average number of shares used to
compute basic and diluted net loss per share
43,163,412 2,208,065 34,618,237
1,828,262
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version on businesswire.com: https://www.businesswire.com/news/home/20190305005834/en/
Nicole Arndt(510) 284-4728narndt@arcusbio.com
Arcus Biosciences (NYSE:RCUS)
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