HOLON, Israel, Nov. 7, 2018 /PRNewswire/ -- Compugen Ltd.
(Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a
leader in predictive target discovery, today reported financial
results for the third quarter ended September 30, 2018.
"The last few months have been highly productive for Compugen,
with strong execution marked by multiple key accomplishments. In
September, we dosed the first patient in our Phase 1 COM701 study,
which continues to progress as planned. Shortly thereafter, we
signed a clinical collaboration agreement with Bristol-Myers
Squibb, providing for the supply of Opdivo® for the combination
arms of the trial, as well as establishing the opportunity to
accelerate the clinical evaluation of COM701 through other
combination studies," said Anat
Cohen-Dayag, Ph.D., President and CEO of Compugen. "With
Bayer's first patient dosing in their Phase 1 study of BAY 1905254
this quarter, there are now two ongoing clinical trials addressing
novel targets we discovered through computer prediction; further
evidence of the power and value of our computational discovery
platform."
"Our preclinical data demonstrate that PVRIG and TIGIT are the
primary inhibitory components of the foundational immuno-oncology
DNAM axis, and that PVRIG is a key missing piece for cancer
immunotherapy approaches that involve solely targeting the TIGIT
pathway in this axis. Our research demonstrates that targeting
PVRIG will be necessary to maximize the anti-tumor activity of
TIGIT inhibitors, with or without PD-1 inhibitors, in various
cancer types and patient populations. This is supported by initial
clinical data released by others that show encouraging but modest
effects of anti-TIGIT antibodies in Phase 1 clinical trials."
"As the only anti-PVRIG drug candidate currently available for
clinical testing, COM701 stands out in the crowded field of
immuno-oncology and offers a compelling opportunity to counteract
the inhibition of the DNAM axis and potentially address the
significant unmet medical need of cancer patients who are relapsed
or refractory to other immunotherapies. Moreover, this program
illustrates our differentiated approach to drug discovery and
development; one that is guided by three principals – a focus on
new pathways aimed at addressing a significant unmet need, a
science-driven approach to select optimal drug combinations; and a
robust rationale and strategy for patient selection based on a deep
scientific understanding of the new pathways."
"We are confident that this differentiated approach will
continue to produce high-potential, first-in-class therapeutic
candidates in our earlier stage immuno-oncology programs," Dr.
Cohen-Dayag concluded.
Recent highlights:
- Entered into a clinical trial collaboration with Bristol-Myers
Squibb. The collaboration includes the supply of Opdivo® for the
Phase 1 dual combination arm of COM701 and Opdivo® and a framework
for expansion to additional combination studies, such as PVRIG and
TIGIT blockers. In addition, Bristol-Myers Squibb made a
$12 million equity investment in
Compugen.
- First patient dosed in the Phase 1 study for COM701.
- First patient dosed in the Phase 1 study for BAY 1905254 which
triggered a milestone payment of $7.8
million from Bayer.
Financial Results
Revenues for the third quarter of 2018 were $7.8 million, compared with $0 in the comparable period of 2017. The revenues
for the quarter reflect the milestone achieved from Bayer AG in
connection with the dosing of the first patient in the Phase 1
study of BAY 1905254.
R&D expenses for the third quarter ended September 30, 2018, were $7.8 million, compared with $7.6 million for the comparable period in
2017. R&D expenses continue to reflect pre-clinical expenses
associated with COM902 in preparation of the IND application filing
anticipated in 2019 and clinical expenses associated with the
COM701 Phase 1 trial which was initiated in September 2018.
Net loss for the third quarter of 2018 was $3.1 million, or $0.05 per diluted share, compared with a net loss
of $9.9 million, or $0.19 per diluted share, in the comparable period
of 2017.
As of September 30, 2018, cash,
cash related accounts, short-term and long-term bank deposits
totaled $34.9 million, compared with
$30.4 million at December 31, 2017. The quarter-end cash balance
does not include the $12 million
equity investment by Bristol-Myers Squibb or the $7.8 million for the milestone from Bayer
AG. The Company has no debt.
Conference Call and Webcast Information
Compugen will hold a conference call to discuss its third
quarter 2018 results today, November 7, 2018, at 8:30 a.m. ET. To access the live conference call
by telephone, please dial 1-888-407-2553 from the U.S., or
+972-3-918-0644 internationally. The conference 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 www.cgen.com.
(Tables to follow)
About Compugen
Compugen is a clinical-stage therapeutic discovery and
development company utilizing its broadly applicable predictive
discovery infrastructure to identify novel drug targets and develop
first-in-class therapeutics in the field of cancer immunotherapy.
The Company's therapeutic pipeline consists of immuno-oncology
programs against novel drug targets it has discovered, including T
cell immune checkpoints and myeloid target programs. Compugen's
business model is to selectively enter into collaborations for its
novel targets and related drug product candidates at various stages
of research and development. The Company is headquartered in
Israel with R&D facilities in
both Israel and South San Francisco, CA. Compugen's ordinary
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.
Forward-Looking Statement
This press release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements can be identified by the use of
terminology such as "will," "may," "expects," "anticipates,"
"believes," "potential," "plan," "goal," "estimate," "likely,"
"should," "confident," and "intends," and describe opinions about
possible future events. 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: 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. Moreover, the
development and commercialization of therapeutic candidates involve
many inherent risks, including failure to progress to clinical
trials or, if they progress to or enter clinical trials, failure to
receive regulatory approval. These and other factors, including the
ability to finance the Company, 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.
COMPUGEN
LTD.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
(U.S. dollars in
thousands, except for share and per share amounts)
|
|
|
Three Months
Ended
|
Nine Months
Ended
|
|
September
30,
|
September
30,
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
Unaudited
|
|
Unaudited
|
|
Unaudited
|
|
Unaudited
|
|
|
|
|
|
|
|
|
Revenues
|
7,800
|
|
-
|
|
17,800
|
|
-
|
Cost of
revenues
|
684
|
|
-
|
|
1,034
|
|
-
|
Gross
profit
|
7,116
|
|
-
|
|
16,766
|
|
-
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
|
|
|
Research and
development expenses
|
7,759
|
|
7,620
|
|
22,854
|
|
21,413
|
Marketing and
business development expenses
|
692
|
|
289
|
|
1,389
|
|
898
|
General and
administrative expenses
|
1,997
|
|
2,070
|
|
6,074
|
|
5,708
|
Total operating
expenses
|
10,448
|
|
9,979
|
|
30,317
|
|
28,019
|
|
|
|
|
|
|
|
|
Operating
loss
|
(3,332)
|
|
(9,979)
|
|
(13,551)
|
|
(28,019)
|
Financial and other
income, net
|
221
|
|
108
|
|
351
|
|
263
|
Loss before taxes
on income
|
(3,111)
|
|
(9,871)
|
|
(13,200)
|
|
(27,756)
|
Taxes on
income
|
-
|
|
-
|
|
-
|
|
-
|
Net
loss
|
(3,111)
|
|
(9,871)
|
|
(13,200)
|
|
(27,756)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per ordinary share
|
(0.05)
|
|
(0.19)
|
|
(0.25)
|
|
(0.54)
|
Weighted average
number of ordinary shares
used in computing basic and diluted net loss
per share
|
57,207,077
|
|
51,163,404
|
|
53,855,582
|
|
51,142,277
|
|
|
|
|
|
|
|
|
COMPUGEN
LTD.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS DATA
|
|
(U.S. dollars in
thousands)
|
|
|
September
30,
|
December
31,
|
|
2018
|
|
2017
|
|
Unaudited
|
|
Audited
|
ASSETS
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
Cash, cash
equivalents, short-term bank deposits and restricted
cash
|
34,901
|
|
30,438
|
Trade
Receivable
|
7,800
|
|
-
|
Other accounts
receivable and prepaid expenses
|
1,789
|
|
741
|
Total current
assets
|
44,490
|
|
31,179
|
|
|
|
|
Non-current
assets
|
|
|
|
Long-term prepaid
expenses
|
235
|
|
110
|
Severance pay
fund
|
2,641
|
|
2,810
|
Property and
equipment, net
|
3,656
|
|
4,647
|
Total non-current
assets
|
6,532
|
|
7,567
|
|
|
|
|
Total
assets
|
51,022
|
|
38,746
|
|
|
|
|
|
|
|
|
LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
Other accounts
payable, accrued expenses and trade payables
|
9,658
|
|
6,194
|
Total current
liabilities
|
9,658
|
|
6,194
|
|
|
|
|
Non-current
liabilities
|
|
|
|
Accrued severance
pay
|
3,197
|
|
3,255
|
Total non-current
liabilities
|
3,197
|
|
3,255
|
|
|
|
|
Total
shareholders' equity
|
38,167
|
|
29,297
|
Total liabilities
and shareholders' equity
|
51,022
|
|
38,746
|
|
|
|
|
Company contact:
Elana Holzman
Director, Investor Relations and Corporate Communications
Compugen Ltd.
Email: elanah@cgen.com
Tel: +972 (3) 765-8124
Investor Relations contact:
Burns McClellan, Inc.
Jill Steier
Email: jsteier@burnsmc.com
Tel: 212-213-0006
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content:http://www.prnewswire.com/news-releases/compugen-reports-third-quarter-2018-results-300745551.html
SOURCE Compugen Ltd.