Corvus Pharmaceuticals Reports Second Quarter 2017 Financial Results and Provides Business Update
August 03 2017 - 4:10PM
Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage
biopharmaceutical company focused on the development and
commercialization of novel immuno-oncology therapies, today
announced financial results for the second quarter ended June 30,
2017, and provided a business update.
“We continue to make significant progress in advancing the
clinical development of our lead product candidate, CPI-444, and
other product candidates in our immuno-oncology pipeline,” said
Richard A. Miller, M.D., co-founder, president and chief executive
officer of Corvus. “We presented results from our ongoing Phase
1/1b study at the recent ASCO Annual Meeting, demonstrating
promising clinical activity with CPI-444 in patients with non-small
cell lung cancer and renal cell cancer who are resistant or
refractory to prior anti-PD-(L)1 therapy. This is a
difficult-to-treat and growing patient population, as there are
very few treatment options for patients who have been given
checkpoint inhibitor therapy, but whose disease has either
continued to advance or has returned. With CPI-444 and other
product candidates in our pipeline targeting the adenosine pathway,
we now have several novel agents focused on this important new
target in immuno-oncology.”
Recent Achievements and Upcoming
MilestonesClinical and Preclinical
- Continued enrolling patients in four expansion cohorts in the
ongoing disease-specific expansion part of the Phase 1/1b clinical
study of CPI-444, the Company’s lead oral checkpoint inhibitor. The
expanded cohorts include treatment with CPI-444 both as a single
agent and in combination with atezolizumab (Tecentriq®), an
anti-PD-L1 antibody, in renal cell cancer (RCC) and non-small cell
lung cancer (NSCLC). Corvus plans to present additional data from
this study at the Society for Immunotherapy of Cancer (SITC) 32nd
Annual Meeting in November 2017.
- Presented interim safety and efficacy data from 75 patients
with RCC or NSCLC enrolled in the Phase 1/1b study in an oral
presentation at the American Society of Clinical Oncology (ASCO)
2017 Annual Meeting. The data showed that treatment with CPI-444
both as a single agent and in combination with atezolizumab
resulted in anti-tumor activity in patients resistant or refractory
to prior treatment with anti-PD-(L)1 antibodies and in patients
with PD-L1 negative tumors.
- Entered into a second collaboration agreement with Genentech to
evaluate CPI-444 in combination with atezolizumab in a Phase 1b/2
clinical study as second-line therapy in patients with NSCLC who
are resistant/refractory to prior anti-PD-(L)1 antibody therapy.
Genentech and Corvus will share the costs of the trial that is
expected to be initiated in the fourth quarter of 2017.
- Continued to progress the anti-CD73 antibody program toward
Phase 1 study initiation in the first half of 2018.
- Continued to progress both A2B receptor antagonist and ITK
inhibitor programs. Preclinical findings with a candidate A2B
receptor antagonist indicate that it may enhance immune responses
to certain tumors. These findings, which suggest the possible
use of A2A receptor and A2B receptor antagonists in combination
therapy, may lead to selection of a lead clinical candidate A2B
receptor antagonist in 2018.
- Initiated development of an in-licensed antibody-based product
candidate that inhibits a novel target in the adenosine
pathway.
Corporate
- Held an R&D Day titled “The Adenosine Pathway: Extending
the Reach of Cancer Immunotherapy.” An archive of the webcast is
available in the “Investors” section of the Company’s website.
- Licensed global rights to an undisclosed novel immuno-oncology
program, which includes a lead product candidate, from Monash
University.
Financial ResultsAt June 30, 2017, Corvus had
cash, cash equivalents and marketable securities totaling
$110.3 million. This compared to cash, cash equivalents and
marketable securities of $134.9 million at December 31, 2016.
Research and development expenses for the three months ended
June 30, 2017, totaled $12.4 million compared to $7.1 million for
the same period in 2016. The increase of $5.3 million was primarily
due to an increase of $3.0 million in outside clinical trial and
contracted research costs associated with the Phase 1/1b clinical
trial for CPI-444, an increase of $1.2 million in drug
manufacturing costs for the anti-CD73 antibody program, and an
increase of $0.7 million in drug manufacturing costs for the ITK
program.
General and administrative expenses for the three months ended
June 30, 2017, totaled $2.8 million compared to $1.7 million for
the same period in 2016. The increase of $1.1 million was primarily
due to an increase of $0.4 million in personnel and associated
costs, primarily due to an increase in headcount, a $0.3 million
increase in legal and accounting costs, and an increase of $0.3
million in costs associated with being a public company.
The net loss for the three months ended June 30, 2017, was $15.0
million compared to $8.6 million for the same period in 2016. Total
stock compensation expense for the three months ended June 30,
2017, was $1.5 million compared to $1.1 million for the same period
in 2016.
About Corvus Pharmaceuticals Corvus
Pharmaceuticals is a clinical-stage biopharmaceutical company
focused on the development and commercialization of small molecule
and antibody agents that target the immune system to treat patients
with cancer. These agents block or modify crucial immune
checkpoints and reprogram immune T-cells. Corvus’ lead product,
CPI-444, is a checkpoint inhibitor that is designed to disable a
tumor’s ability to subvert attack by the immune system by
inhibiting adenosine in the tumor microenvironment. CPI-444 is a
small molecule that is taken orally. CPI-444 is currently being
evaluated in a multicenter Phase 1/1b clinical trial in patients
with various solid tumors. This successive expansion cohort trial
is examining the activity of CPI-444 both as a single agent and in
combination with Genentech’s atezolizumab, an anti-PD-L1
antibody. Corvus is conducting the trial with Genentech, a
member of the Roche Group, under a clinical trial collaboration the
two companies entered into in October 2015. For more information,
visit: www.corvuspharma.com.
Tecentriq® (atezolizumab) is a registered trademark of
Genentech.
Forward-Looking Statements This press release
contains forward-looking statements, including statements related
to the potential safety and efficacy of CPI-444, both as a single
agent and in combination with anti-PD-1 or anti-PD-L1, the
Company’s or Genentech’s ability to develop and advance product
candidates into and successfully complete clinical trials,
including the Company’s Phase 1/1b clinical trial of CPI-444, and
Genentech’s expected Phase 1b/2 clinical trial of CPI-444 in
combination with atezolizumab, and the timing of any future
clinical trials; and the potential utility of preclinical findings
in the selection of product candidates. All statements other than
statements of historical fact contained in this press release are
forward-looking statements. These statements often include words
such as “believe,” “expect,” “anticipate,” “intend,” “plan,”
“estimate,” “seek,” “will,” “may” or similar expressions.
Forward-looking statements are subject to a number of risks and
uncertainties, many of which involve factors or circumstances that
are beyond the Company’s control. The Company’s actual results
could differ materially from those stated or implied in
forward-looking statements due to a number of factors, including
but not limited to, risks detailed in the Company’s Quarterly
Report on Form 10-Q for the three months ended June 30, 2017, filed
with the Securities and Exchange Commission on August 3, 2017, as
well as other documents that may be filed by the Company from time
to time with the Securities and Exchange Commission. In particular,
the following factors, among others, could cause results to differ
materially from those expressed or implied by such forward-looking
statements: the Company’s ability to demonstrate evidence of
efficacy and safety for CPI-444 during its Phase 1/1b clinical
trial; the accuracy of the Company’s estimates relating to its or
Genentech’s ability to initiate and/or complete clinical trials o
the ability of Genentech to demonstrate evidence of efficacy and
safety for CPI-444 during its expected Phase 1b/2 clinical trial;
the results of preclinical findings and early clinical trials may
not be predictive of future results; the unpredictability of the
regulatory process; and regulatory developments in the United
States and foreign countries. Although the Company believes that
the expectations reflected in the forward-looking statements are
reasonable, it cannot guarantee that the events and circumstances
reflected in the forward-looking statements will be achieved or
occur, and the timing of events and circumstances and actual
results could differ materially from those projected in the
forward-looking statements. Accordingly, you should not place undue
reliance on these forward-looking statements. All such statements
speak only as of the date made, and the Company undertakes no
obligation to update or revise publicly any forward-looking
statements, whether as a result of new information, future events
or otherwise.
CORVUS PHARMACEUTICALS,
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (in thousands, except share and per share
data)(unaudited) |
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
|
|
|
June 30, |
|
June 30, |
|
|
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research
and development |
$ |
12,386 |
|
|
$ |
7,119 |
|
|
$ |
25,884 |
|
|
$ |
12,517 |
|
|
|
General
and administrative |
|
2,788 |
|
|
|
1,706 |
|
|
|
5,507 |
|
|
|
2,734 |
|
|
|
Total operating
expenses |
|
15,174 |
|
|
|
8,825 |
|
|
|
31,391 |
|
|
|
15,251 |
|
|
|
Loss from
operations |
|
(15,174 |
) |
|
|
(8,825 |
) |
|
|
(31,391 |
) |
|
|
(15,251 |
) |
|
|
Interest income |
|
193 |
|
|
|
180 |
|
|
|
374 |
|
|
|
259 |
|
|
|
Net loss |
$ |
(14,981 |
) |
|
$ |
(8,645 |
) |
|
$ |
(31,017 |
) |
|
$ |
(14,992 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted |
$ |
(0.73 |
) |
|
$ |
(0.43 |
) |
|
$ |
(1.52 |
) |
|
$ |
(1.42 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute
net loss per share, basic and diluted
|
|
20,426,849 |
|
|
|
19,959,459 |
|
|
|
20,388,820 |
|
|
|
10,568,562 |
|
|
|
|
|
|
|
|
|
|
|
|
|
CORVUS PHARMACEUTICALS,
INC. |
|
CONDENSED CONSOLIDATED BALANCE
SHEETS |
|
(in thousands) |
|
(unaudited) |
|
|
|
June 30, |
|
December 31, |
|
|
|
2017 |
|
2016 |
|
Assets |
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
110,326 |
|
$ |
134,896 |
|
Other assets |
|
|
5,161 |
|
|
5,254 |
|
Total
assets |
$ |
115,487 |
|
$ |
140,150 |
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
Accounts payable and accrued liabilities and other
liabilities |
|
$ |
10,705 |
|
$ |
7,349 |
|
Stockholders' equity |
|
|
104,782 |
|
|
132,801 |
|
Total
liabilities and stockholders’ equity |
$ |
115,487 |
|
$ |
140,150 |
|
Investor Contact:
Leiv Lea
Chief Financial Officer
650-900-4522
LLea@corvuspharma.com
Media Contact:
Julie Normart, W2O Group
415-946-1087
jnormart@w2ogroup.com
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