– 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
HAYWARD, Calif.–(BUSINESS WIRE)–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.
-
AB928 in combination with Doxil® in triple negative breast 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.
-
AB928 in combination with carboplatin/pemetrexed and pembrolizumab
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
|
43,508,592 | 9,488,352 | ||||||||
Contacts
Katherine Bock
(415) 533-5670
kbock@arcusbio.com
Nicole Arndt
(510) 284-4728
narndt@arcusbio.com