BURLINGAME, Calif., Nov. 02, 2017 (GLOBE NEWSWIRE) -- 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 third quarter ended September 30, 2017, and provided a business update.
“We continue to advance the clinical development of our lead product candidate, CPI-444, and other product candidates in our
pipeline,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “We continue to enroll
patients with renal cell cancer (RCC) and non-small cell lung cancer in expansion cohorts of our Phase 1/1b trial for both single
agent and combination therapy with atezolizumab. For RCC, protocol-defined criteria for a second expansion to 48 patients
from 26 has been achieved. Updated clinical and biomarker data has been accepted for oral presentation at the upcoming
Society for Immunotherapy of Cancer (SITC) meeting in National Harbor, MD. in November.”
Recent Achievements and Upcoming Milestones
Clinical 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). For both single agent and combination RCC cohorts, the protocol-defined criteria
for a second expansion of the cohorts from 26 to 48 patients has been met.
- Additional data from the ongoing CPI-444 study will be presented by Jason J. Luke, M.D., FACP, Assistant Professor of
Medicine, University of Chicago Medicine at the Society for Immunotherapy of Cancer (SITC) 32nd Annual Meeting in November
2017.
- Expect initial patient enrollment in the fourth quarter 2017 in a previously announced second collaboration agreement with
Genentech to evaluate CPI-444 in combination with atezolizumab in a Phase 1b/2 clinical study as second- or third-line therapy in
patients with NSCLC who are resistant/refractory to prior anti-PD-(L)1 antibody therapy.
- Continued to progress the anti-CD73 antibody program toward Phase 1 study initiation, which is expected in the first half of
2018.
- Have selected oral ITK inhibitor lead candidate that is now in IND enabling studies.
Financial Results
At September 30, 2017, Corvus had cash, cash equivalents and marketable securities totaling $99.7 million 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 September 30, 2017, totaled $10.7 million compared to $7.7 million
for the same period in 2016. The increase of $3.0 million was primarily due to an increase of $2.8 million in outside clinical
trial costs associated with the Phase 1/1b clinical trial for CPI-444.
General and administrative expenses for the three months ended September 30, 2017, totaled $2.2 million compared to $2.8 million
for the same period in 2016. The decrease of $0.6 million was primarily due to a decrease of $0.6 million in patent and related
costs.
The net loss for the three months ended September 30, 2017, was $12.7 million compared to $10.3 million for the same period in
2016. Total stock compensation expense for the three months ended September 30, 2017, was $1.5 million compared to $1.3 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. In May 2015, Corvus and
Genentech entered into a second clinical trial collaboration under which Genentech is conducting a Phase 1b/2 clinical trial with
CPI-444 and atezolizumab as 2nd or 3rd line therapy for non-small cell lung cancer. 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 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. 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 September 30, 2017, filed with
the Securities and Exchange Commission on November 2, 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 accuracy of the Company’s estimates
relating to its or Genentech’s ability to initiate and/or complete clinical trials ; 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.
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
CORVUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
Nine Months Ended |
|
|
|
September
30, |
|
September
30, |
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
$ |
10,733 |
|
|
$ |
7,707 |
|
|
$ |
36,617 |
|
|
$ |
20,224 |
|
|
|
General and administrative |
|
2,211 |
|
|
|
2,769 |
|
|
|
7,718 |
|
|
|
5,502 |
|
|
|
Total operating expenses |
|
12,944 |
|
|
|
10,476 |
|
|
|
44,335 |
|
|
|
25,726 |
|
|
|
Loss from operations |
|
(12,944 |
) |
|
|
(10,476 |
) |
|
|
(44,335 |
) |
|
|
(25,726 |
) |
|
|
Interest income |
|
227 |
|
|
|
179 |
|
|
|
601 |
|
|
|
437 |
|
|
|
Net loss |
$ |
(12,717 |
) |
|
$ |
(10,297 |
) |
|
$ |
(43,734 |
) |
|
$ |
(25,289 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted |
$ |
(0.62 |
) |
|
$ |
(0.51 |
) |
|
$ |
(2.14 |
) |
|
$ |
(1.83 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute net loss per share, basic and diluted |
|
20,501,382 |
|
|
|
20,183,497 |
|
|
|
20,426,263 |
|
|
|
13,797,927 |
|
|
|
|
|
|
|
|
|
|
|
|
|
CORVUS PHARMACEUTICALS, INC. |
|
CONDENSED CONSOLIDATED BALANCE
SHEETS |
|
(in thousands) |
|
(unaudited) |
|
|
|
September 30, |
|
December 31, |
|
|
|
2017 |
|
2016 |
|
Assets |
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
99,700 |
|
$ |
134,896 |
|
Other assets |
|
|
5,088 |
|
|
5,254 |
|
Total assets |
$ |
104,788 |
|
$ |
140,150 |
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
Accounts payable and accrued liabilities and other
liabilities |
|
$ |
11,051 |
|
$ |
7,349 |
|
Stockholders' equity |
|
|
93,737 |
|
|
132,801 |
|
Total liabilities and stockholders’ equity |
$ |
104,788 |
|
$ |
140,150 |
|