Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage
biopharmaceutical company, today provided a business update and
announced financial results for the second quarter ended June 30,
2020.
“In the second quarter, we advanced each of our three clinical
oncology programs, highlighted by the presentation of new data at
ASCO on the identification of a refined biomarker that enriches for
responding patients with renal cell cancer treated with our lead
candidate, ciforadenant,” said Richard A. Miller, M.D.,
president and chief executive officer of Corvus. “Based on this
data, we are planning to meet with the U.S. Food & Drug
Administration (FDA) to discuss the initiation of a pivotal study
of ciforadenant in renal cell cancer. For CPI-006 and CPI-818, we
have largely completed enrollment in the current portions of their
Phase 1/1b studies and expect to report updated results at medical
meetings later this year.”
“We also added a fourth program utilizing our novel
immunomodulatory antibody CPI-006 for treatment of patients with
mild-to-moderate COVID-19. Our unique approach is based on the
ability of CPI-006 to activate B cells, leading to the production
of anti-SARS-CoV-2 IgM and IgG antibodies and memory B cells, which
has the potential to shorten recovery time and improve long-term
protective immunity. The study is advancing on track with the first
cohort of five patients fully enrolled and four of five patients
now enrolled in the second cohort. We expect to report
anti-SARS-CoV-2 antibody and memory B cell results from our study
later this year.”
Recent Achievements
Ciforadenant (CPI-444): A2A Receptor Antagonist of Adenosine
- Presented updated data from the Phase 1b/2 clinical trial of
ciforadenant in patients with refractory renal cell carcinoma (RCC)
at the ASCO20 Virtual Scientific Program. The data covered 51
patients and showed an objective response rate (ORR) of 17% by
RECIST criteria in Adenosine Gene Signature positive patients
(n=31) and 0% ORR in the Adenosine Gene Signature negative group
(n=20). The ORR improved to 27% with a refined version of the
test, which is based on the measurement of CD68 positive myeloid
cells, the downstream target of adenosine.
CPI-006: Anti-CD73 Antibody with Immunomodulatory Activity
- Initiated an open-label, Phase 1 study of CPI-006 in COVID-19
patients with mild to moderate symptoms. Patients will receive a
single dose of CPI-006, with levels of 0.3, 1.0, 3.0 and 5.0 mg/kg,
escalating in four cohorts as the study progresses. Patients will
receive medications, therapies, and interventions per standard
treatment protocols for COVID-19 for the duration of the study. The
primary efficacy endpoint is the change in serum immunoglobulin
(IgM and IgG) anti-SARS-CoV-2 levels compared to baseline at day
28. The study will also examine safety and effects on anti-viral
memory B cells and other clinical endpoints, including time to
resolution of symptoms and duration of hospitalization.
- COVID-19 Study Update: Since the
announcement of the study and enrollment of the first cohort of
five patients in early July, four of five patients in the second
cohort have been enrolled in the study. As of the cutoff date of
July 30, 2020, no dose limiting toxicities had been noted and early
anti-SARS-CoV-2 antibody response data was encouraging with
relatively high titers of IgG and IgM to both spike and receptor
binding domain (RBD) viral proteins observed. In the first two
patients receiving the lowest dose of CPI-006 and tested at an
early Day 7 time point, IgG titers to spike protein were >
1:25,000 and > 1:50,000. One of these patients has
also completed Day 14 testing, which showed the titers to viral
spike protein and RBD had increased to > 1:100,000.
Significant levels of IgM antibodies were also detected. The
Company remains on track to report 28-day follow up results from
the Phase 1 study later this year.
- Completed enrollment in three dose escalation arms of the
CPI-006 Phase 1/1b cancer clinical trial: monotherapy, combination
with ciforadenant and combination with pembrolizumab and we
continue to enroll the triplet combination dose escalation arm with
ciforadenant and pembrolizumab. Updated clinical data from the
Phase 1/1b oncology clinical trial is targeted to be presented
later this year.
CPI-818: A small molecule ITK inhibitor
- Completed enrollment in the dose escalation portion (N=16) of
the CPI-818 Phase 1/1b clinical trial, which included patients with
several types of advanced, refractory T-cell lymphomas. Based on
results from this portion of the study, including a confirmed
complete response in one patient with peripheral T-cell lymphoma
(PTCL) who previously failed chemotherapy and high dose
chemotherapy with autologous bone marrow transplantation, the
Company selected the CPI-818 optimum dose and began the next
portion of the study with a focus on patients with PTCL and
cutaneous T-cell lymphoma (CTCL).
Anticipated Future Events
- Data from the Phase 1 trial of CPI-006 used to treat COVID-19
patients later this year.
- The Company plans to meet with the FDA to discuss the study
design and plans for a ciforadenant pivotal study in advanced
refractory RCC using the Adenosine Gene Signature as a
biomarker.
- Updated clinical data from the CPI-006 Phase 1/1b oncology
clinical trial is planned to be presented later this
year.
- Updated clinical data from the CPI-818 Phase 1/1b clinical
trial is planned to be presented at the American Society of
Hematology (ASH) annual meeting in December 2020.
Financial ResultsAt June 30, 2020, Corvus had
cash, cash equivalents and marketable securities totaling
$59.3 million, as compared to cash, cash equivalents and
marketable securities of $78.0 million at December 31, 2019.
Corvus expects net cash used in operating activities for the second
half of 2020 to be between $12 million and $14 million resulting in
a cash balance of between $47 million and $45 million at December
31, 2020.
Research and development expenses for the three months ended
June 30, 2020 totaled $7.9 million compared to $10.6 million for
the same period in 2019. The decrease of $2.7 million was primarily
due to a $0.5 million decrease in ciforadenant clinical trial
expenses, a $1.7 million decrease in CPI-006 drug manufacturing
costs, a $0.5 million decrease in CPI-818 drug manufacturing costs
and a $0.8 million decrease in outside service costs, partially
offset by a $1.1 million increase in CPI-006 clinical trial
expenses.
The net loss for the three months ended June 30, 2020 was $10.6
million, compared to a net loss of $13.0 million for the same
period in 2019. Total stock compensation expense for the three
months ended June 30, 2020 was $1.4 million compared to $1.9
million of total stock compensation expense for the same period in
2019.
Conference Call DetailsCorvus will host a
conference call and webcast today, Thursday, July 30, 2020, at 4:30
p.m. ET (1:30 p.m. PT), during which time management will provide a
business update and discuss the second quarter 2020 financial
results. The conference call can be accessed by dialing
1-855-327-6837 (toll-free domestic) or 1-631-891-4304
(international) and using the conference ID 10010533. The live
webcast may be accessed via the investor relations section of the
Corvus website. A replay of the webcast will be available on
Corvus' website for 90 days.
About Corvus Pharmaceuticals Corvus
Pharmaceuticals is a clinical-stage biopharmaceutical company.
Corvus’ lead product candidates are ciforadenant (CPI-444), a small
molecule inhibitor of the A2A receptor, and CPI-006, a humanized
monoclonal antibody directed against CD73 that exhibits
immunomodulatory activity and activation of immune cells. These
product candidates are being studied in ongoing Phase 1b/2 and
Phase 1/1b clinical trials in patients with a wide range of
advanced solid tumors. Ciforadenant is being evaluated in a
successive expansion cohort Phase 1b/2 trial examining its activity
both as a single agent and in combination with an anti-PD-L1
antibody. CPI-006 is being evaluated in a multicenter Phase 1/1b
clinical trial as a single agent, in combination with ciforadenant
and pembrolizumab. The Company’s third cancer clinical program,
CPI-818, an oral, small molecule drug that has been shown to
selectively inhibit ITK, is in a multicenter Phase 1/1b clinical
trial in patients with several types of T-cell lymphomas. The
Company is also evaluating CPI-006 as a treatment for COVID-19
patients. For more information, visit
www.corvuspharma.com.
About CiforadenantCiforadenant (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.
Adenosine Gene Signature and CD68+ Myeloid
CellsThe adenosine gene signature is a biomarker that
reflects adenosine induced immunosuppression in the tumor.
These genes express chemokines that recruit myeloid cells including
immunosuppressive tumor associated CD68+ myeloid cells, which are
thought to mediate resistance to anti-PD-(L)1 treatment. To date,
in our clinical trial of renal cell cancer, this biomarker has been
associated with a higher rate of response to ciforadenant. CD68+
cells can be enumerated using standard immunohistochemical
techniques that are routinely available in pathology
laboratories.
About CPI-006CPI-006 is a potent humanized
monoclonal antibody that reacts with a specific site on CD73. It
has demonstrated immunomodulatory activity resulting in activation
of lymphocytes, induction of antibody production from B cells and
effects on lymphocyte trafficking. While there are other anti-CD73
antibodies in development for treatment of cancer, such antibodies
have been reported to react with a different region of CD73 and are
designed to block production of adenosine, which is not involved in
the immunomodulatory processes seen with CPI-006.
About CPI-818CPI-818 is a small molecule drug
given orally that has been shown to selectively inhibit ITK
(interleukin-2-inducible T-cell kinase). It was developed to
possess dual properties: to block malignant T-cell growth and
modulate immune responses. ITK, an enzyme, is expressed
predominantly in T-cells and plays a role in T-cell and natural
killer (NK) cell lymphomas and leukemias, as well as in normal
immune function. Interference with ITK signaling can modulate
immune responses to various antigens. The inhibition of specific
molecular targets in T-cells may be of therapeutic benefit for
patients with T-cell lymphomas – similar to the role of Bruton’s
tyrosine kinase (BTK) in B-cells.
Forward-Looking Statements This press release
contains forward-looking statements, including statements related
to the potential safety and efficacy of ciforadenant, CPI-006, and
CPI-818, the Company’s ability to develop and advance product
candidates into and successfully complete preclinical studies and
clinical trials, including the Company’s Phase 1b/2 clinical trial
of ciforadenant, the Company’s Phase 1/1b clinical trial of
CPI-006, the Company’s Phase 1/1b clinical trial of CPI-818,
in each case, for certain cancers, as well as the Company’s Phase 1
trial of CPI-006 for COVID-19, the timing of the availability and
announcement of clinical data, the suitability of dosing regimen
selected for clinical trials, and the impact of COVID-19 and
related “shelter in place” orders and other public health guidance
measures on our clinical programs and business operations, and the
expected cash needs and operating expenses for the second half of
2020. 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 June 30, 2020, filed with
the Securities and Exchange Commission on July 30, 2020, 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
ciforadenant, CPI-006 and CPI-818; 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
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; regulatory
developments in the United States and foreign countries; the costs
of clinical trials may exceed expectations; the Company’s ability
to raise additional capital; and the effects of COVID-19 on the
Company’s clinical programs and business operations. 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:Leiv LeaChief
Financial OfficerCorvus Pharmaceuticals,
Inc.+1-650-900-4522llea@corvuspharma.com
MEDIA CONTACT:Zack KubowW2O pure+1
917-623-1995zkubow@purecommunications.com
CORVUS PHARMACEUTICALS,
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (in thousands, except share and per share
data)(unaudited)
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
$ |
7,857 |
|
|
$ |
10,640 |
|
|
$ |
18,020 |
|
|
$ |
20,059 |
|
|
General and administrative |
|
2,910 |
|
|
|
2,956 |
|
|
|
6,016 |
|
|
|
5,842 |
|
|
Total operating expenses |
|
10,767 |
|
|
|
13,596 |
|
|
|
24,036 |
|
|
|
25,901 |
|
|
Loss from operations |
|
(10,767 |
) |
|
|
(13,596 |
) |
|
|
(24,036 |
) |
|
|
(25,901 |
) |
|
Interest income and other expense, net |
|
156 |
|
|
|
618 |
|
|
|
490 |
|
|
|
1,280 |
|
|
Net loss |
$ |
(10,611 |
) |
|
$ |
(12,978 |
) |
|
$ |
(23,546 |
) |
|
$ |
(24,621 |
) |
|
Net loss per share, basic and diluted |
$ |
(0.36 |
) |
|
$ |
(0.44 |
) |
|
$ |
(0.80 |
) |
|
$ |
(0.84 |
) |
|
Shares used to compute net loss per share, basic and diluted |
|
29,428,249 |
|
|
|
29,309,150 |
|
|
|
29,419,741 |
|
|
|
29,301,505 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CORVUS PHARMACEUTICALS,
INC.CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
|
|
June 30, |
|
December 31, |
|
|
|
2020 |
|
|
|
2019 |
|
Assets |
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
59,258 |
|
|
$ |
77,982 |
|
Operating lease right-of-use asset |
|
|
1,996 |
|
|
|
2,327 |
|
Other assets |
|
|
2,923 |
|
|
|
3,337 |
|
Total assets |
|
$ |
64,177 |
|
|
$ |
83,646 |
|
Liabilities and stockholders' equity |
|
|
|
|
Accounts payable and accrued liabilities and other liabilities |
|
$ |
10,577 |
|
|
$ |
9,347 |
|
Operating lease liability |
|
|
2,760 |
|
|
|
3,188 |
|
Stockholders' equity |
|
|
50,840 |
|
|
|
71,111 |
|
Total liabilities and stockholders' equity |
|
$ |
64,177 |
|
|
$ |
83,646 |
|
Corvus Pharmaceuticals (NASDAQ:CRVS)
Historical Stock Chart
From Aug 2024 to Sep 2024
Corvus Pharmaceuticals (NASDAQ:CRVS)
Historical Stock Chart
From Sep 2023 to Sep 2024