Arcus Biosciences Announces First Quarter 2018 Financial Results and Recent Corporate Updates
-- Completed dosing in the Phase 1 trial for AB928 in healthy volunteers
-- Regulatory submissions underway to initiate combination trials for AB928 in patients
Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer
immunotherapies, today announced financial results and recent corporate updates for the first quarter ended March 31, 2018.
“The first quarter of 2018 was another exciting period for the Company, as our immuno-oncology pipeline continues to advance,”
said Terry Rosen, Ph.D., Chief Executive Officer at Arcus. “We have submitted regulatory filings to initiate our first combination
trials of AB928, our internally discovered dual adenosine receptor antagonist, with other anti-cancer agents, including our
anti-PD-1 antibody, AB122, and expect to initiate dosing in patients in mid-2018. We are also on track to submit regulatory filings
for our next two product candidates, AB154 and AB680 in the third quarter, and to end the year with four product candidates in
clinical development.”
Pipeline Updates and Upcoming Milestones
AB928 (dual A 2 R receptor antagonist)
- Initiated the submission of regulatory filings for three Phase 1/1b trials to evaluate
AB928 in combination with AB122 or chemotherapy. Each trial will evaluate AB928 in combination with AB122 and/or chemotherapy
in selected tumor types and will be conducted in both Australia and the U.S. The trial protocols were designed to allow for
the addition of other AB928 combinations over time, including triple combinations. There will be a dose-escalation portion which
will be followed by dose-expansion cohorts once the recommended dose of AB928 for each combination has been selected. In both the
dose-escalation portion and expansion cohorts, the Company will conduct significant biomarker analysis, designed to inform
patient selection in future trials. Data from the dose-escalation portion of these trials will be presented in the first half of
2019. The three trials will evaluate AB928 combinations in the following tumor types:
-- Gastrointestinal malignancies (initially colorectal and gastroesophageal cancers)
-- Breast and gynecological (initially ovarian) malignancies
-- Non-small cell lung cancer and renal cell carcinoma
- Completed dosing in the ongoing Phase 1 double-blinded, placebo-controlled trial in
healthy volunteers in April. Final results from this trial, including pharmacodynamic data for the 200 mg QD dosing cohort,
is expected to be released in mid-2018.
- Presented initial data from the Phase 1 trial in a poster presentation at the AACR
Annual Meeting in April. Data showed AB928 is safe and well tolerated at all doses evaluated (up to 200 mg QD) and achieves
near complete inhibition of adenosine 2a receptor (A2aR) activation.
- Presented preclinical data in a poster presentation at the AACR Annual Meeting in
April. Data demonstrated that AB928 in combination with doxorubicin or oxaliplatin results in greater immune activation and
tumor control than that of chemotherapy alone in two different tumor models.
AB122 (anti-PD-1 antibody)
- Initiated dosing of a third cohort in the ongoing Phase 1 dose-escalation trial in
cancer patients in Australia. The Company plans to present safety, pharmacokinetic, receptor occupancy and clinical activity
data from this trial in the second half of 2018.
- Presented preclinical data in a poster presentation at the AACR Annual Meeting in
April. Data demonstrated that AB122 is similar to nivolumab in terms of binding affinity, selectivity and anti-tumor activity
in an animal model.
AB154 (anti-TIGIT antibody)
- Continued to advance CMC activities and GLP toxicology studies. These studies are
being conducted in preparation for the first regulatory submission for AB154 expected in mid-2018.
AB680 (small molecule CD73 inhibitor)
- Presented preclinical discovery and characterization data in a poster presentation at
the AACR Annual Meeting in April. Data demonstrated that AB680 significantly enhanced the activity of anti-PD-1 and
anti-TIGIT antibodies (AB122 and AB154, respectively) in immune function assays demonstrating the potential of triple combination
therapy. This drug has a predicted half-life in humans of several days, which should allow for a dosing regimen of every two or
three weeks.
- Preparing to submit the first regulatory filing to initiate a Phase 1 trial to evaluate
AB680 in healthy volunteers. This trial, which is expected to start in the third quarter of 2018, is designed to evaluate the
safety, pharmacokinetic and pharmacodynamic profile of AB680 in healthy volunteers. Clinical testing of AB680 in cancer patients
is expected to begin in the first half of 2019.
Corporate Updates
- The Company completed an initial public offering in March, raising approximately $124.7 million in
net proceeds after deducting underwriter discounts and other offering-related costs through the sale of 9,200,000 shares of
common stock at a public offering price of $15.00 per share. Proceeds from this offering are currently expected to fund the
company into at least 2020.
First Quarter Financial Results:
- At March 31, 2018, cash, cash equivalents and investments were $290.8 million, compared to $175.7
million at December 31, 2017. The increase was primarily due to the receipt of $124.7 million in net proceeds from the Company’s
initial public offering, which was completed in March.
- Collaboration and license revenue for the first quarter ended March 31, 2018 was $1.3 million,
compared to no revenue for the same period in 2017. The increase in revenue was entirely due to revenue recognized from the
Option and License Agreement the Company entered into with Taiho Pharmaceutical Co., Ltd. in September 2017.
- Research and development expenses for the first quarter ended March 31, 2018 were $11.7 million,
compared to $5.8 million for the same period in 2017. The increase of $5.9 million was primarily due to an increase in
manufacturing and clinical costs to support our ongoing AB928 and AB122 clinical trials and an increase in R&D headcount to
support the Company’s other programs.
- General and administrative expenses for the first quarter ended March 31, 2018 were $2.9 million,
compared to $1.5 million for the same period in 2017. The increase of $1.4 million was primarily due to higher legal and
accounting fees and additional staff in key areas required to support a public company infrastructure, as well as increased
facilities and office expenses related to our expanded facility in Hayward.
- Net loss for the first quarter ended March 31, 2018 was $13.0 million, compared to $7.2 million for
the same period in 2017. The increase in net loss was primarily attributable to the increase in operating expenses noted
above.
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 and an anti-PD-1 antibody, both of which are in Phase 1 trials, as well as a small molecule inhibitor of CD73 and an
anti-TIGIT antibody, which are in IND-enabling studies. 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, 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; the applicability of the results described herein to Arcus’s clinical
development plans and subsequent clinical trials; risks associated with preliminary data; and 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. Risks and uncertainties facing Arcus are described more fully in Arcus’s quarterly report on Form 10-Q for the quarter
ended March 31, 2018 filed on May 9, 2018 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.
|
ARCUS BIOSCIENCES, INC. |
Condensed Consolidated Statement of Operations and Comprehensive
Loss |
(In thousands, except share and per share amounts) |
(unaudited) |
|
|
|
Three Months Ended |
|
|
|
March 31 |
|
|
|
|
2018 |
|
|
|
2017 |
|
Collaboration and license revenue |
|
|
$ |
1,250 |
|
|
$ |
— |
|
Operation expenses: |
|
|
|
|
|
Research and development |
|
|
|
11,652 |
|
|
|
5,804 |
|
General and administrative |
|
|
|
2,929 |
|
|
|
1,496 |
|
Total operating expenses |
|
|
|
14,581 |
|
|
|
7,300 |
|
Loss from operations |
|
|
|
(13,331 |
) |
|
|
(7,300 |
) |
Interest and other income, net |
|
|
|
377 |
|
|
|
100 |
|
Net loss |
|
|
|
(12,954 |
) |
|
|
(7,200 |
) |
Other comprehensive loss |
|
|
|
(55 |
) |
|
|
(8 |
) |
Comprehensive loss |
|
|
$ |
(13,009 |
) |
|
$ |
(7,208 |
) |
Net loss per share, basic and diluted |
|
|
$ |
(1.37 |
) |
|
$ |
(4.96 |
) |
Weighted-average number of shares used to compute basic and diluted net
loss per share |
|
|
|
9,488,352 |
|
|
|
1,452,215 |
|
|
ARCUS BIOSCIENCES, INC. |
Condensed Consolidated Balance Sheets |
(In thousands, except share and per share amounts) |
(unaudited) |
|
|
March 31, |
|
December 31, |
|
|
2018 |
|
2017(1)
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
198,116 |
|
|
$ |
98,426 |
|
Short-term investments |
|
|
82,064 |
|
|
|
77,277 |
|
Prepaid expenses and other current assets |
|
|
1,834 |
|
|
|
1,141 |
|
Amounts owed by a related party |
|
|
54 |
|
|
|
25 |
|
Total current assets |
|
|
282,068 |
|
|
|
176,869 |
|
Long-term investments |
|
|
10,595 |
|
|
|
- |
|
Property, plant and equipment-net |
|
|
11,813 |
|
|
|
11,230 |
|
Equity investment in related party |
|
|
515 |
|
|
|
682 |
|
Restricted cash |
|
|
203 |
|
|
|
203 |
|
Other long-term assets |
|
|
205 |
|
|
|
1,502 |
|
Total assets |
|
$ |
305,399 |
|
|
$ |
190,486 |
|
LIABILITIES |
|
|
|
|
Current liabilities |
|
|
|
|
Accounts payable |
|
$ |
3,920 |
|
|
$ |
3,820 |
|
Accrued liabilities |
|
|
3,610 |
|
|
|
3,137 |
|
Deferred revenue, current |
|
|
5,000 |
|
|
|
5,000 |
|
Other current liabilities |
|
|
1,732 |
|
|
|
769 |
|
Total current liabilities |
|
|
14,262 |
|
|
|
12,726 |
|
Deferred revenue, noncurrent |
|
|
17,337 |
|
|
|
18,587 |
|
Deferred rent |
|
|
4,655 |
|
|
|
4,740 |
|
Other long-term liabilities |
|
|
2,554 |
|
|
|
565 |
|
Total liabilities |
|
|
38,808 |
|
|
|
36,618 |
|
Convertible preferred stock |
|
|
— |
|
|
|
226,196 |
|
Stockholders’ equity (deficit): |
|
|
|
|
Common stock |
|
|
4 |
|
|
|
- |
|
Additional paid-in capital |
|
|
352,872 |
|
|
|
948 |
|
Accumulated deficit |
|
|
(86,188 |
) |
|
|
(73,234 |
) |
Accumulated other comprehensive loss |
|
|
(97 |
) |
|
|
(42 |
) |
Total stockholders’ equity (deficit) |
|
|
266,591 |
|
|
|
(72,328 |
) |
Total liabilities, convertible preferred stock
and stockholders’ equity (deficit) |
|
$ |
305,399 |
|
|
$ |
190,486 |
|
|
|
|
|
|
(1) Derived from the audited financial statements for the year ended
December 31, 2017, included in the Company's Prospectus filed with the Stock Exchange Commission, dated March 14, 2018. |
Arcus Biosciences
Jennifer Jarrett, 510-694-6261
jjarrett@arcusbio.com
or
Nicole Arndt, 510-284-4728
narndt@arcusbio.com
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