Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq:
CRVS), a clinical-stage biopharmaceutical company, today provided a
business update and reported financial results for the quarter
ended March 31, 2022.
“We are advancing our three clinical product candidates
according to a clear strategy focused on the interaction of tumors
with the immune system,” said Richard A. Miller, M.D., co-founder,
president and chief executive officer of Corvus. “Our product
candidates have demonstrated enhanced immune responses to a wide
range of solid and hematologic cancers and are designed to act
alone or in combinations. We are a leader in the modulation of CD73
and adenosine to affect tumor immunity, with mid-to-late stage
clinical trials for mupadolimab and ciforadenant on track for
initiation later this year. In addition, we have demonstrated
encouraging potential of our ITK inhibitor on T cell
differentiation, raising important new potential applications in
cancer and autoimmune diseases.”
2022 Key Areas of FocusCorvus is advancing
three clinical programs in 2022, including plans for a Phase 2
study for mupadolimab in front-line non-small cell lung cancer
(NSCLC), a Phase 1b/2 study for ciforadenant in front-line renal
cell cancer (RCC), and the ongoing Phase 1/1b study for CPI-818 in
T-cell lymphoma.
The Company will host an R&D Symposium on Tuesday, May 10,
2022 to provide an update on these clinical programs. The event
will take place in New York City from 9:00 – 11:30 am Eastern Time.
A webcast of the event will be available on the Corvus website at
www.corvuspharma.com.
Mupadolimab (anti-CD73)
- The Company continues to enroll its two Phase 1b/2 clinical
trial expansion cohorts of patients with (1) head and neck cancers
that have failed previous treatment with anti-PD-1 therapy and
chemotherapy and (2) relapsed refractory NSCLC who have failed
previous treatment with anti-PD(L)-1 therapy and chemotherapy. Up
to 15 patients will be enrolled in each expansion cohort and
treated with the combination of mupadolimab and pembrolizumab.
- The Company plans to initiate a randomized Phase 2 clinical
trial evaluating mupadolimab as a front-line therapy for the
treatment of patients with advanced NSCLC later this year. The
randomized, blinded clinical trial will compare standard
chemotherapy plus pembrolizumab (anti-PDL-1) with or without
mupadolimab. The Company intends to enroll approximately 150
patients with any tumor PDL-1 expression in the clinical trial,
potentially addressing a large patient population. The primary
endpoint for the study will be progression free survival and
secondary endpoints will evaluate objective response rate and
overall survival.
Ciforadenant (adenosine 2a receptor
antagonist)
- The Company plans to collaborate with the Kidney Cancer
Clinical Trials Consortium to initiate an open-label Phase 2
clinical trial evaluating ciforadenant as a first-line therapy for
metastatic RCC in combination with ipilimumab (anti-CTLA-4) and
nivolumab (anti-PD-1). The clinical trial, which is anticipated to
be initiated in the third quarter 2022, will enroll up to 60
patients and is intended to evaluate the potential for ciforadenant
to generate increased complete responses and deep responses in the
front-line setting. The Kidney Cancer Clinical Trials Consortium is
comprised of a group of leading cancer centers in the United States
led by investigators at MD Anderson. The trial design is based on
Corvus’ preclinical research published in 2018 in Cancer Immunology
Research that demonstrated impressive antitumor control and cures
in several animal models using ciforadenant in combination with
anti-CTLA4 and anti-PD1.
CPI-818 (selective ITK inhibitor)
- Corvus and its partner in China, Angel Pharmaceuticals, are
enrolling patients with relapsed T cell lymphomas in Phase 1/1b
trial evaluating single agent therapy with CPI-818. Angel
Pharmaceuticals is responsible for all expenses related to
conducting the clinical trial in China. Monitoring of immune
modulation of normal T cells as well as safety and anti-tumor
activity are being assessed in the clinical trial, with data
expected later this year. Based on interim results observed in
patients with peripheral T cell lymphoma (PTCL) in these Phase 1/1b
clinical trials, the Company believes such results could provide
the foundation for a potential global phase 2 clinical trial in
advanced PTCL.
Financial ResultsAs of March 31, 2022, Corvus
had cash, cash equivalents and marketable securities totaling
$62.9 million. This compared to cash, cash equivalents and
marketable securities of $69.5 million as of December 31, 2021.
Research and development expenses for the three months ended
March 31, 2022 totaled $5.1 million compared to $8.2 million for
the same period in 2021. The decrease of $3.1 million was primarily
due to lower outside clinical trial and personnel costs.
The net loss for the three months ended March 31, 2022 was $8.3
million compared to a net loss of $11.6 million for the same period
in 2021. Total stock compensation expense for the three months
ended March 31, 2022 was $0.7 million compared to $1.2 million for
the same period in 2021 and the non-cash loss from our equity
method investment in Angel Pharmaceuticals was $1.0 million for the
three months ended March 31, 2022 compared to $0.1 million in the
same period in 2021.
About Corvus PharmaceuticalsCorvus
Pharmaceuticals is a clinical-stage biopharmaceutical company.
Corvus’ lead product candidate is mupadolimab (CPI-006), a
humanized monoclonal antibody directed against CD73 that has
exhibited immunomodulatory activity and activation of immune cells
in preclinical and clinical studies. The Company’s second clinical
program, CPI-818, is an investigational, oral, small molecule drug
that selectively inhibited ITK in preclinical studies and is in a
multicenter Phase 1/1b clinical trial in patients with several
types of T-cell lymphomas. Its third clinical program, ciforadenant
(CPI-444), is an oral, small molecule inhibitor of the A2A
receptor. For more information, visit www.corvuspharma.com.
About MupadolimabMupadolimab (CPI-006) is an
investigational, potent humanized monoclonal antibody that is
designed to react with a specific site on CD73. In preclinical
studies, 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 and small molecules in development for
treatment of cancer, such agents react with a different region of
CD73. Mupadolimab is designed to react with a region of the
molecule that acts to stimulate B cells and block production of
immunosuppressive adenosine. Mupadolimab is being studied in
combination with pembrolizumab in a Phase 1b/2 clinical trial in
patients with advanced head and neck cancers and in patients with
NSCLC that have failed chemotherapy and anti-PD(L)1 therapy. It is
postulated that the activation of B cells will enhance immunity
within the tumors of these patients, leading to improved clinical
outcomes.
About CPI-818CPI-818 is an investigational
small molecule drug given orally that has selectively inhibited ITK
(interleukin-2-inducible T-cell kinase) in preclinical studies. It
was designed to possess dual properties: to block malignant T-cell
growth and to 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 Company believes
the inhibition of specific molecular targets in T-cells may be of
therapeutic benefit for patients with T-cell lymphomas and
leukemias and in patients with autoimmune diseases. The Company is
conducting a Phase 1/1b trial in patients with refractory T-cell
lymphomas that was designed to select the optimal dose of CPI-818
and evaluate its safety, PK, target occupancy, biomarkers and
efficacy. Interim data from the Phase 1/1b clinical trial of
CPI-818 for T cell lymphoma demonstrated tumor responses in very
advanced, refractory, difficult to treat T cell malignancies.
About CiforadenantCiforadenant (CPI-444) is an
investigational 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.
About Angel PharmaceuticalsAngel
Pharmaceuticals is a privately held biopharmaceutical company
developing a pipeline of precisely targeted investigational
medicines for cancer, autoimmune, infectious and other serious
diseases in China. Angel Pharmaceuticals was launched through
a collaboration with U.S.-based Corvus
Pharmaceuticals and investments from investors in China.
Angel Pharmaceuticals licensed the rights to develop and
commercialize Corvus’ three clinical-stage candidates –
mupadolimab, CPI-818 and ciforadenant – in
greater China and obtained global rights to Corvus’ BTK
inhibitor preclinical programs. Under the collaboration, Corvus
currently has a 49.7% equity stake in Angel Pharmaceuticals
excluding 7% of Angel’s equity reserved for issuance under the
Angel ESOP, and Corvus has designated three individuals on Angel’s
five-person Board of Directors. For more information,
visit www.angelpharma.com.
Forward-Looking Statements This press release
contains forward-looking statements, including statements related
to the potential safety and efficacy of mupadolimab, CPI-818 and
ciforadenant; the Company’s ability and Angel Pharmaceutical’s
ability, as well as the timing thereof, to develop and advance
product candidates into and successfully complete preclinical
studies and clinical trials, including the Company’s planned Phase
2 clinical trial of mupadolimab, the Company and Angel’s Phase 1/1b
clinical trials of CPI-818 as well as a potential global phase 2
study clinical trial in advanced PTCL and the Company’s plan to
initiate a Phase 2 clinical trial with ciforadenant in
collaboration with the Kidney Cancer Clinical Trials Consortium;
the timing of the availability and announcement of clinical data
and certain other product development milestones, including the
timing of initial results in the Phase 1b/2 clinical trial for
CPI-818; and the expected trial design and number of patients
enrolled in the Company’s upcoming planned 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, 2022, filed
with the Securities and Exchange Commission on or about the date
hereof, 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 mupadolimab, CPI-818 and ciforadenant; the
accuracy of the Company’s estimates relating to its ability to
initiate and/or complete preclinical studies and clinical trials;
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 other foreign countries;
regulatory developments in the United States, and other foreign
countries; the costs of clinical trials may exceed expectations;
and the Company’s ability to raise additional capital. 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. The Company’s results for
the quarter ended March 31, 2022 are not necessarily indicative of
its operating results for any future periods.
CORVUS PHARMACEUTICALS, INC.CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except
share and per share data) |
|
|
|
|
|
Three Months Ended March 31, |
|
|
2022 |
|
|
|
2021 |
|
|
(unaudited) |
Operating expenses: |
|
|
|
Research and development |
$ |
5,100 |
|
|
$ |
8,230 |
|
General and administrative |
|
2,313 |
|
|
|
3,253 |
|
Total operating expenses |
|
7,413 |
|
|
|
11,483 |
|
Loss from operations |
|
(7,413 |
) |
|
|
(11,483 |
) |
Interest income and other expense, net |
|
11 |
|
|
|
3 |
|
Sublease income - related party |
|
146 |
|
|
|
- |
|
Loss from equity method investment |
|
(1,041 |
) |
|
|
(100 |
) |
Net (loss) income |
$ |
(8,297 |
) |
|
$ |
(11,580 |
) |
Net (loss) income per share, basic and diluted |
$ |
(0.18 |
) |
|
$ |
(0.34 |
) |
Shares used to compute net (loss) income per share, basic and
diluted |
|
46,553,511 |
|
|
|
34,515,116 |
|
|
|
|
|
CORVUS PHARMACEUTICALS, INC.CONDENSED
CONSOLIDATED BALANCE SHEETS(in thousands) |
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2021 |
|
|
|
2021 |
|
|
(unaudited) |
|
|
Assets |
|
|
|
Cash, cash equivalents and marketable securities |
$ |
62,944 |
|
|
$ |
69,451 |
|
Operating lease right-of-use asset |
|
2,952 |
|
|
|
3,190 |
|
Other assets |
|
2,023 |
|
|
|
2,548 |
|
Investment in Angel Pharmaceuticals |
|
33,371 |
|
|
|
34,266 |
|
Total assets |
$ |
101,290 |
|
|
$ |
109,455 |
|
Liabilities and stockholders' equity |
|
|
|
Accounts payable and accrued liabilities and other liabilities |
$ |
8,175 |
|
|
$ |
8,646 |
|
Operating lease liability |
|
3,393 |
|
|
|
3,647 |
|
Stockholders' equity |
|
89,722 |
|
|
|
97,162 |
|
Total liabilities and stockholders' equity |
$ |
101,290 |
|
|
$ |
109,455 |
|
|
|
|
|
INVESTOR CONTACT:Leiv LeaChief Financial
OfficerCorvus Pharmaceuticals,
Inc.+1-650-900-4522llea@corvuspharma.com
MEDIA CONTACT:Sheryl SeapyReal
Chemistry+1-949-903-4750sseapy@realchemistry.com
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