Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage
biopharmaceutical company focused on the development and
commercialization of precisely targeted oncology therapies, today
announced financial results for the first quarter ended March 31,
2018, and provided a business update.
“We made important progress in advancing our clinical programs
and building our pipeline, with several notable developments in the
first quarter that reinforce our continued leadership in the
development of therapies targeting the adenosine pathway,” said
Richard A. Miller, M.D., co-founder, president and chief executive
officer of Corvus. “We are now enrolling patients in our Phase 1/1b
trial evaluating CPI-006 as a monotherapy, in combination with
CPI-444 and in combination with Keytruda® (pembrolizumab). We
believe this is the first human clinical trial in oncology to
evaluate the effect of dual-blockade of the adenosine pathway by
inhibiting both CD73 and the A2A receptor. With the
initiation of this new trial and our ongoing Phase 1/1b clinical
trial with our A2A receptor antagonist CPI-444, we continue to have
one of the most advanced programs addressing the adenosine pathway.
Our clinical trials with CPI-444 are expanding in both renal cell
and lung cancer and are designed to evaluate its use in earlier
lines of therapy.”
Recent AchievementsCPI-444: A2A Receptor
Antagonist of Adenosine
- Amended the clinical trial protocol for the ongoing Phase 1/1b
clinical trial evaluating CPI-444, the Company’s lead product
candidate, administered alone and in combination with Genentech’s
Tecentriq® (atezolizumab), an anti-PD-L1 antibody, in up to 50
patients with renal cell cancer (RCC) who have failed no more than
two prior treatment regimens, which must have included an
anti-PD-(L)1 and a tyrosine kinase inhibitor. Prior to this
amendment, RCC patients were eligible and enrolled with up to five
(median three) prior treatments regimens.
- Continued enrolling patients in the Phase 1b/2 trial, being
conducted by Genentech as part of their MORPHEUS platform, which is
evaluating CPI-444 and Tecentriq in up to 60 patients with
non-small cell lung cancer (NSCLC) who have failed no more than two
prior regimens.
CPI-006: Anti-CD73 Antibody
- As recently announced, initiated the Phase 1/1b clinical trial
evaluating CPI-006, the Company’s anti-CD73 antibody, as a single
agent and in combination with CPI-444, and in combination with
pembrolizumab. The trial is anticipated to enroll up to 350
patients and is designed to select the dose and evaluate the
safety, pharmacokinetics, immune biomarkers and efficacy in
patients with NSCLC, RCC, and other cancers who have failed
standard therapies.
Preclinical
- Advanced Investigational New Drug (IND) enabling studies and
additional preclinical trials in spontaneous canine T-cell lymphoma
for the Company’s interleukin-2–inducible kinase (ITK) inhibitor
and progressed scale-up manufacturing activities in preparation for
an anticipated IND filing in late 2018.
Corporate
- Raised $64.9 million in net proceeds in March 2018 through an
underwritten public offering, broadening our investor base.
Financial ResultsAt March 31, 2018, Corvus had
cash, cash equivalents and marketable securities totaling
$143.9 million. This compared to cash, cash equivalents
and marketable securities of $90.1 million at December 31, 2017.
Research and development expenses for the three months ended
March 31, 2018 totaled $12.1 million compared to $13.5 million for
the same period in 2017. The decrease of $1.4 million was primarily
due to the payment of a $3.0 million milestone related to CPI-444
in the first quarter of 2017, partially offset by an increase of
$0.5 million in drug manufacturing costs for CPI-006 and an
increase of $0.7 million in personnel costs.
General and administrative expenses for the three months ended
March 31, 2018 totaled $2.5 million compared to $2.7 million for
the same period in 2017. The decrease of $0.2 million was primarily
due to a decrease of $0.4 million in patent and public company
expenses, offset by an increase of $0.2 million in personnel
costs.
The net loss for the three months ended March 31, 2018 was $14.3
million compared to $16.0 million for the same period in 2017.
Total stock compensation expense for the three months ended March
31, 2018 was $1.8 million compared to $1.5 million for the same
period in 2017.
About Corvus Pharmaceuticals Corvus
Pharmaceuticals is a clinical-stage biopharmaceutical company
focused on the development and commercialization of precisely
targeted oncology therapies. Corvus’ lead product candidate,
CPI-444, a small molecule inhibitor of the A2A receptor, 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. In May 2017, Corvus
and Genentech expanded the collaboration and are now conducting a
trial of CPI-444 and atezolizumab in patients with NSCLC who have
failed prior therapies with anti-PD-(L)1 and platinum based
chemotherapy. Corvus is evaluating a second product candidate,
CPI-006, a humanized monoclonal antibody directed against CD73, in
a multicenter Phase 1/1b clinical trial in patients with various
solid tumors. For more information, visit www.corvuspharma.com.
Tecentriq® is a registered trademark of Genentech.Keytruda® is a
registered trademark of Merck.
About CPI-444 CPI-444 is a small molecule,
oral, checkpoint inhibitor designed to disable a tumor’s ability to
subvert attack by the immune system by blocking the binding of
adenosine in the tumor microenvironment to the A2A receptor.
Adenosine, a metabolite of ATP (adenosine tri-phosphate), is
produced within the tumor microenvironment where it may bind to the
adenosine A2A receptor present on immune cells and block their
activity. CD39 and CD73 are enzymes on the surface of tumor cells
and immune cells. These enzymes work in concert to convert ATP to
adenosine. In vitro and preclinical studies have shown that dual
blockade of CD73 and the A2A receptor may be synergistic.
About CD73 and AdenosineCD73 is a cell surface
enzyme whose function is to convert adenosine monophosphate (AMP)
to adenosine by removing phosphate from AMP. CD73 is expressed
on cells of the immune system, including T-cells and B-cells. CD73
is also present on many tumors, including lung, renal, melanoma,
colon, prostate, breast and others. In the tumor microenvironment,
CD73 produces adenosine, which binds to the adenosine A2A receptor
on immune cells and inhibits various immune responses including
those directed against the tumor. Tumors utilize this
immunosuppressive mechanism to escape attack by the immune
system.
About CPI-006CPI-006 is a potent humanized
monoclonal antibody that reacts with the active site of CD73,
blocking the conversion of AMP to adenosine. In vitro studies of
CPI-006 have shown it is capable of substantially inhibiting the
production of adenosine by blocking the CD73 enzyme.
Forward-Looking Statements This press release
contains forward-looking statements, including statements related
to the potential safety and efficacy of CPI-144 and CPI-006, the
Company’s ability to develop and advance product candidates into
and successfully complete preclinical studies and clinical trials,
including the Company’s Phase 1/1b clinical trial of CPI-444, the
Company’s Phase 1/1b clinical trial of CPI-006 and the Company’s
IND-enabling studies of its ITK inhibitor, the basis for and the
timing of any future clinical trials of the Company’s ITK inhibitor
and the utility of biomarker data collected and the suitability of
dosing regimen selected for clinical trials. 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 quarter ended March 31, 2018, filed
with the Securities and Exchange Commission on May 3, 2018, 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 sufficient
evidence of efficacy and safety in its clinical trials of CPI-144
and CPI-006; the accuracy of the Company’s estimates relating to
its ability to initiate and/or complete preclinical studies and
clinical trials; the Company’s ability to demonstrate sufficient
evidence of efficacy and safety in its preclinical studies of its
ITK inhibitor; the Company’s ability to utilize biomarker data and
select a suitable dosing regimen; the results of preclinical
studies 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.
INVESTOR CONTACT:Guillermo Elias,
Ph.D.Director, Business DevelopmentCorvus Pharmaceuticals,
Inc.+1-650-900-4511gelias@corvuspharma.com
MEDIA CONTACT:Julie Normart, W2O Group
415-946-1087jnormart@w2ogroup.com
|
CORVUS PHARMACEUTICALS, INC.CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share
and per share data)(unaudited) |
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
|
|
2018 |
|
|
|
2017 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
|
|
|
|
$ |
12,103 |
|
|
$ |
13,497 |
|
General
and administrative |
|
|
|
|
|
|
2,541 |
|
|
|
2,720 |
|
Total operating
expenses |
|
|
|
|
|
|
14,644 |
|
|
|
16,217 |
|
Loss from
operations |
|
|
|
|
|
|
(14,644 |
) |
|
|
(16,217 |
) |
Interest income |
|
|
|
|
|
|
343 |
|
|
|
181 |
|
Net loss |
|
|
|
|
|
$ |
(14,301 |
) |
|
$ |
(16,036 |
) |
Net loss per share,
basic and diluted |
|
|
|
|
|
$ |
(0.63 |
) |
|
$ |
(0.79 |
) |
Shares used to compute
net loss per share, basic and diluted |
|
|
|
|
|
|
22,580,620 |
|
|
|
20,349,391 |
|
|
|
|
|
|
|
|
|
|
CORVUS PHARMACEUTICALS, INC.CONDENSED
CONSOLIDATED BALANCE SHEETS (in thousands)(unaudited) |
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
|
|
|
|
2018 |
|
2017 |
Assets |
|
|
|
|
|
|
|
|
Cash,
cash equivalents and marktable securities |
|
|
|
|
|
$ |
143,933 |
|
$ |
90,055 |
Other
assets |
|
|
|
|
|
|
4,756 |
|
|
4,720 |
Total assets |
|
|
|
|
|
$ |
148,689 |
|
$ |
94,775 |
Liabilities and
stockholders' equity |
|
|
|
|
|
|
|
|
Accounts
payable and accrued liabilities and other liabilities |
|
|
|
|
|
$ |
11,461 |
|
$ |
9,940 |
Stockholders' equity |
|
|
|
|
|
|
137,228 |
|
|
84,835 |
Total liabilities and
stockholders' equity |
|
|
|
|
|
$ |
148,689 |
|
$ |
94,775 |
|
|
|
|
|
|
|
|
|
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