HOLON, Israel, July 28, 2021 /PRNewswire/ -- Compugen
Ltd. (NASDAQ: CGEN), a clinical-stage cancer immunotherapy
company and a leader in predictive target discovery, today reported
financial results for the second quarter ended June 30, 2021.
"Our continued execution in the clinic, which includes the
recent initiation of three clinical studies, further strengthens
Compugen's leadership position in the DNAM axis space," said
Anat Cohen-Dayag, Ph.D., President
and CEO of Compugen. "These new studies expand our comprehensive
evaluation of the DNAM axis and leave us uniquely positioned as the
only company, in a clinical setting, evaluating anti-PVRIG,
anti-TIGIT and anti-PD-1 combinations, which is our key
differentiator in the TIGIT space. We expect the remainder of the
year to include data readouts from our triple combination study in
collaboration with Bristol Myers Squibb and COM902 monotherapy
study, which we expect to expand the foundation of our clinical
data generated to date."
Dr. Cohen-Dayag continued, "The updated data from our COM701
Phase 1 combination and monotherapy studies presented at ASCO
support our continued excitement in our science and potential
benefit it may bring to patients, showing durable responses and
disease control in patients not eligible for or typically not
responding to checkpoint inhibitors including those with prior
progression. In addition, we shared our first preliminary
pharmacodynamic biomarker data indicating that treatment with
COM701 leads to immune activation and has the potential to drive
anti-tumor activity in non-inflamed tumors as evidenced by activity
in selected PD-L1 low, PVRL2 positive patients. Our
combination strategy around our wholly owned assets targeting PVRIG
and TIGIT give us a strong first mover advantage, and we look
forward to continued progress through 2021 as we work to elucidate
the potential of the DNAM axis pathways in
immunotherapy."
Recent and Second Quarter 2021 Corporate Highlights
- Presented updated data from the COM701 monotherapy and
combination with Opdivo® (nivolumab) studies at the ASCO 2021
Annual Meeting including:
- Durable responses beyond one year, including one
complete response, in tumor types typically unresponsive to
checkpoint inhibitors
- Preliminary biomarker data reveal immune
activation evidenced by a trend of increased proliferation of
peripheral immune cells and IFNγ. IFNγ increased with increasing
doses of COM701, suggesting the observed activity is likely derived
from the combination treatment and not Opdivo® alone
- Preliminary anti-tumor activity in PD-L1 low,
PVRL2 positive patients, with non-inflamed tumor
microenvironment/immune desert phenotype
- Dosed the first patient in the Phase 1b cohort expansion study of COM701 in
combination with Opdivo® in patients with ovarian, breast,
endometrial and microsatellite-stable colorectal cancers
- Dosed the first patient in the Phase 1 dual combination study
of COM902 and COM701 in patients with advanced malignancies, the
first clinical study of dual blockade of TIGIT and PVRIG
independent of anti-PD-1
- Dosed the first patient in the Phase 1/2 triple combination
cohort expansion of COM701 with Opdivo® and Bristol Myers Squibb's
anti-TIGIT antibody, BMS-986207
- Presented research at the Society for Immunotherapy of Cancer
(SITC) Targets for Cancer Immunotherapy: A Deep Dive Seminar
Series, supporting PVRIG as a novel and differentiated checkpoint
in the DNAM axis
Financial Results
R&D expenses for the second quarter ended June 30, 2021, were $6.8
million compared with $4.4
million for the comparable period in 2020. The
increase in R&D expenses reflects the strong execution and
expansion of the Phase 1 clinical programs.
General and administrative expenses for the second quarter ended
June 30, 2021, were $2.7 million compared with $2.1 million for the comparable period in 2020.
The increase in expenses is attributed mainly to corporate related
expenses.
Net loss for the second quarter of 2021 was $9.5 million, or $0.11 per basic and diluted share, compared with
a net loss of $6.2 million, or
$0.08 per basic and diluted share, in
the comparable period of 2020.
As of June 30, 2021, cash, cash
related accounts, short-term and long-term bank deposits totaled
approximately $111 million, compared
with approximately $124 million on
December 31, 2020. The Company has no
debt.
Conference Call and Webcast Information
The Company will hold a conference call today, July 28, 2021, at 8:30 AM
ET to review its second quarter 2021 results. To access the
live conference call by telephone, please dial 1-866-744-5399 from
the U.S., or +972-3-918-0644 internationally. The call will also be
available via live webcast through Compugen's website, located at
the following link. Following the live audio webcast, a replay will
be available on the Company's website.
About Compugen
Compugen is a clinical-stage therapeutic discovery and
development company utilizing its broadly applicable, predictive
computational discovery platforms to identify novel drug targets
and develop therapeutics in the field of cancer
immunotherapy. Compugen's lead product candidate, COM701,
a first-in-class anti-PVRIG antibody, for the treatment of solid
tumors, is undergoing Phase 1 single, dual, and
triple combination studies. In addition,
COM902, Compugen's antibody targeting TIGIT, is in a
Phase 1 clinical study. Compugen's therapeutic pipeline
also includes early-stage immuno-oncology programs
focused largely on myeloid targets. Compugen is
headquartered in Israel, with
offices in South San Francisco, CA. Compugen's shares are
listed on Nasdaq and the Tel Aviv Stock Exchange under the
ticker symbol CGEN. For additional information, please
visit Compugen's corporate website
at www.cgen.com.
Opdivo® is a registered trademark of Bristol Myers Squibb.
Forward-Looking Statement
This press release contains "forward-looking statements" within
the meaning of the Securities Act of 1933 and the Securities
Exchange Act of 1934, as amended, and the safe-harbor provisions of
the Private Securities Litigation Reform Act of 1995. Such
forward-looking statements are based on the current
beliefs, expectations, and assumptions of Compugen.
Forward-looking statements can be
identified using terminology such as "will," "may,"
"expects," "anticipates," "believes," "potential," "plan," "goal,"
"estimate," "likely," "should," "confident," and "intends," and
similar expressions that are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. Forward-looking statements include,
but are not limited to, statements relating to our expectations
regarding the timing and readouts of data from our escalation,
triple combination and monotherapy studies and our expectation that
such readouts from the triple combination and monotherapy studies
would expand the foundation of clinical data generated to date with
COM701, statements to the effect that treatment with COM701 leads
to immune activation and has the potential to drive anti-tumor
activity in non-inflamed tumors, statements that preliminary
biomarker data reveal immune activation suggesting the observed
activity is derived from the combination treatment of COM701
together with Opdivo® and not Opdivo® alone and statements that
suggest that COM701 may drive anti-tumor activity also in
non-inflamed tumors. These forward-looking statements involve
known and unknown risks and uncertainties that may cause the actual
results, performance, or achievements
of Compugen to be materially different from any future
results, performance or achievements expressed or implied by such
forward-looking statements. Among these risks: the effect of
the global COVID-19 pandemic may continue to
negatively impact the global economy and may also adversely
affect Compugen's business; clinical development
involves a lengthy and expensive process, with an uncertain outcome
and Compugen may encounter substantial delays or even an
inability to begin clinical studies for any specific product, or
may not be able to conduct or complete its studies on the timelines
it expects; Compugen relies and expects to continue to
rely on third parties to conduct its clinical studies and these
third parties may not successfully carry out their
contractual duties, comply with regulatory requirements or meet
expected deadlines, and Compugen may experience
significant delays in the conduct of its clinical studies as
well as significant increased
expenditures; Compugen's business model is substantially
dependent on entering into collaboration agreements with third
parties and Compugen may not be successful in generating
adequate revenues or commercializing aspects of its business
model; Compugen's approach to the discovery of
therapeutic products is based on its proprietary computational
target discovery infrastructure, which is unproven clinically;
and Compugen does not know whether it will be able to
discover and develop additional potential product candidates or
products of commercial value. These risks and other risks are
more fully discussed in the "Risk Factors" section
of Compugen's most recent Annual Report on Form 20-F as
filed with the Securities and Exchange Commission (SEC) as well as
other documents that may be subsequently filed
by Compugen from time to time with the SEC. In addition,
any forward-looking statements represent Compugen's views
only as of the date of this release and should not be relied upon
as representing its views as of any subsequent
date. Compugen does not assume any obligation to update
any forward-looking statements unless required by law.
Company contact:
Yvonne Naughton, PhD
Head of Investor Relations and Corporate Communications
Email: ir@cgen.com
Tel: +1 (628) 241-0071
COMPUGEN
LTD.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(U.S. dollars in
thousands, except for share and per share amounts)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Six
Months Ended,
|
|
June
30,
|
|
June
30,
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
Unaudited
|
|
Unaudited
|
|
Unaudited
|
|
Unaudited
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
|
|
|
Research and
development expenses
|
6,797
|
|
4,447
|
|
14,123
|
|
9,159
|
Marketing and
business development expenses
|
241
|
|
204
|
|
465
|
|
414
|
General and
administrative expenses
|
2,659
|
|
2,131
|
|
5,373
|
|
4,607
|
Total operating
expenses
|
9,697
|
|
6,782
|
|
19,961
|
|
14,180
|
Financial and other
income, net
|
200
|
|
536
|
|
559
|
|
806
|
Loss before taxes
on income
|
(9,497)
|
|
(6,246)
|
|
(19,402)
|
|
(13,374)
|
Taxes on
income
|
-
|
|
-
|
|
-
|
|
-
|
Net
loss
|
(9,497)
|
|
(6,246)
|
|
(19,402)
|
|
(13,374)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per ordinary
share
|
(0.11)
|
|
(0.08)
|
|
(0.23)
|
|
(0.18)
|
Weighted average
number of ordinary shares
used in computing basic and diluted net loss
per share
|
83,799,634
|
|
81,273,240
|
|
83,739,983
|
|
75,774,881
|
|
|
|
|
|
|
|
|
COMPUGEN
LTD.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS DATA
|
(U.S. dollars, in
thousands)
|
|
|
|
|
|
June
30,
|
|
December
31,
|
|
|
2021
|
|
2020
|
|
|
Unaudited
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
Cash, cash
equivalents, short-term bank deposits
and restricted cash
|
111,092
|
|
124,432
|
|
Trade
receivables
|
|
|
2,000
|
|
Other accounts
receivable and prepaid expenses
|
2,662
|
|
2,658
|
|
Total current
assets
|
113,754
|
|
129,090
|
|
|
|
|
|
|
Non-current
assets
|
|
|
|
|
Long-term prepaid
expenses
|
1,906
|
|
1,880
|
|
Severance pay
fund
|
3,017
|
|
2,863
|
|
Operating lease right
to use asset
|
2,415
|
|
2,772
|
|
Property and
equipment, net
|
1,724
|
|
1,711
|
|
Total non-current
assets
|
9,062
|
|
9,226
|
|
|
|
|
|
|
Total
assets
|
122,816
|
|
138,316
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
SHAREHOLDERS EQUITY
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
Other accounts
payable, accrued expenses
and trade payables
|
10,484
|
|
9,216
|
|
Current maturity of
operating lease liability
|
706
|
|
639
|
|
Short-term deferred
participation in R&D expenses
|
660
|
|
668
|
|
Total current
liabilities
|
11,850
|
|
10,523
|
|
|
|
|
|
|
Non-current
liabilities
|
|
|
|
|
Long-term deferred
participation in R&D expenses
|
1,798
|
|
1,968
|
|
Long-term operating
lease liability
|
2,141
|
|
2,527
|
|
Accrued severance
pay
|
3,606
|
|
3,516
|
|
Total non-current
liabilities
|
7,545
|
|
8,011
|
|
|
|
|
|
|
Total
shareholders' equity
|
103,421
|
|
119,782
|
|
|
|
|
|
|
Total liabilities
and shareholders' equity
|
122,816
|
|
138,316
|
|
|
|
|
|
|
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SOURCE Compugen Ltd.