HOLON, Israel, Feb. 26, 2019 /PRNewswire/ -- Compugen Ltd.
(NASDAQ: CGEN), a leader in predictive discovery and development of
first-in-class therapeutics for cancer immunotherapy, today
reported financial results for the fourth quarter and full year
ended December 31, 2018.
Compugen also announced a corporate restructuring to reduce
costs by consolidating and streamlining R&D operations.
Anticipated cost reductions are expected to extend the Company's
cash runway through mid-2020 to enable the planned expansion of the
ongoing Phase 1 study for COM701, a first-in-class immunotherapy
antibody targeting the PVRIG checkpoint, which continues to
progress as planned. In addition, the Company will maintain
investment in its proprietary computational discovery platform and
will continue to advance its earlier stage immuno-oncology pipeline
programs, which are the Company's two long-term core value
drivers.
"2018 was a pivotal year for Compugen in which two clinical
trials were initiated for our computationally-discovered
immuno-oncology programs, COM701 and BAY 1905254, and we
partnered with Bristol-Myers Squibb and AstraZeneca," said
Anat Cohen-Dayag, Ph.D., President
and CEO of Compugen. "After reaching these important inflection
points in our corporate development, the management team and Board
undertook a strategic review of the Company's operations and cost
structure to ensure effective use of capital in support of the
Company's long-term objectives."
"This restructuring will allow us to focus the necessary
resources to execute the COM701 study, including the initiation of
combination studies with Opdivo®. Of equal importance is the
decision to consolidate and streamline our R&D infrastructure
and continue investing in our two long-term core value drivers.
These difficult decisions are necessary to effectively use our
capital to ensure our future growth and the achievement of our
strategic objectives. We will implement these organizational
changes with the utmost respect for our employees, who I thank for
their dedication and significant contributions made to our
organization."
Corporate Restructuring
The restructuring includes:
- Consolidation of R&D activities in one location
(Israel). Positions and operations
eliminated will also reduce overlapping R&D and G&A
activities in Israel and
the United States;
- A 35% workforce reduction (approximately 35 employees), the
majority of which is in R&D;
- Certain preclinical activities will be outsourced to
third-party service providers;
- IND filing for COM902 in 2019 will proceed as planned.
Initiation of the Phase 1 trial for this program will be dependent
on the drug combination trials pursued under the collaboration with
Bristol-Myers Squibb as well as available resources to support this
trial;
- Clinical development and business development activities will
continue to operate in the United
States; and
- Compugen anticipates savings of up to $10 million on an annual basis. Cash expenditures
for 2019 including one-time restructuring related costs, are
expected to be in the range of $27 to
$29 million, with the full effect of the savings reflected in
2020.
Recent Corporate Highlights
- Published two peer-reviewed papers in Cancer Immunology
Research demonstrating the role of PVRIG as a novel immune
checkpoint target for cancer immunotherapy;
- Awarded U.S. patent No. 10,124,061 from the U.S. Patent and
Trademark Office for the method of using COM902, an anti-TIGIT
monoclonal antibody, for activating T cells in cancer patients
under the Cancer Moonshot program;
- Signed a clinical trial collaboration with Bristol-Myers Squibb
for a Phase 1 combination study of COM701 and Opdivo;
- Received a $12 million investment
from Bristol-Myers Squibb as part of the collaboration;
- Initiated the COM701 monotherapy dose escalation Phase 1
clinical trial in advanced solid tumor patients; and
- Bayer initiated a Phase 1 study for BAY 1905254, its
first-in-class therapeutic antibody program targeting ILDR2,
computationally-discovered by Compugen.
Financial Results
Revenues for the year ended December 31,
2018 were $17.8 million,
compared with $0 in the comparable
period of 2017. The revenues for 2018 reflect the upfront
payment of $10 million from the license agreement with
AstraZeneca and the $7.8 million
milestone payment 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 fourth quarter and year ended
December 31, 2018 were $7.5 million and $30.3
million, respectively, compared with $7.2 million and $28.6
million for the comparable periods in 2017. The increase
reflects the expenses associated with the ongoing Phase 1 study of
COM701.
Net loss for the fourth quarter of 2018 was $9.4 million, or $0.16 per diluted share, compared with a net loss
of $9.3 million, or $0.18 per diluted share, in the comparable period
of 2017. Net loss for the year ended December 31, 2018 was $22.6 million, or $0.41 per diluted share, compared with a net loss
of $37.1 million, or $0.72 per diluted share, for the year ended
December 31, 2017.
As of December 31, 2018, cash,
cash related accounts, short-term and long-term bank deposits
totaled $45.7 million, compared with
$30.4 million at December 31, 2017. The Company has no debt.
Based on current cash and anticipated savings resulting from
restructuring activities, the Company expects its cash runway to
extend through mid-2020, not including potential cash inflow from
existing or new business development arrangements.
Conference Call and Webcast Information
Compugen will hold a conference call to discuss its fourth
quarter and full year 2018 results today, February 26, 2019, 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 +972-3-918-0610
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.
(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 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, including
statements regarding the potential benefits and consequences from
our corporate restructuring and anticipated cash expenditures and
savings through 2020. 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
drug target candidates and their related therapeutic product
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
|
|
Year
Ended
|
|
|
|
December
31,
|
|
December
31,
|
|
|
|
2018
|
|
2017
|
|
2018
|
2017
|
|
|
|
Unaudited
|
|
Unaudited
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
-
|
|
-
|
|
17,800
|
|
-
|
|
Cost of
revenues
|
|
-
|
|
-
|
|
1,034
|
|
-
|
|
Gross
profit
|
|
-
|
|
-
|
|
16,766
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
Research and
development expenses
|
7,464
|
|
7,170
|
|
30,318
|
|
28,583
|
|
Marketing and
business development expenses
|
245
|
|
291
|
|
1,634
|
|
1,189
|
|
General and
administrative expenses
|
1,967
|
|
1,925
|
|
8,041
|
|
7,633
|
|
Total operating
expenses
|
9,676
|
|
9,386
|
|
39,993
|
|
37,405
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
(9,676)
|
|
(9,386)
|
|
(23,227)
|
|
(37,405)
|
|
Financial and other
income, net
|
277
|
|
76
|
|
628
|
|
339
|
|
Loss before taxes
on income
|
(9,399)
|
|
(9,310)
|
|
(22,599)
|
|
(37,066)
|
|
Taxes on
income
|
|
-
|
|
-
|
|
-
|
|
-
|
|
Net
loss
|
(9,399)
|
|
(9,310)
|
|
(22,599)
|
|
(37,066)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per ordinary share
|
(0.16)
|
|
(0.18)
|
|
(0.41)
|
|
(0.72)
|
|
Weighed average
number of ordinary shares
|
|
|
|
|
|
|
|
|
used in computing
basic and diluted net loss
|
|
|
|
|
|
|
|
|
per share
|
59,542,963
|
|
51,290,725
|
|
55,277,428
|
|
50,179,694
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COMPUGEN
LTD.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS DATA
|
(U.S. dollars in
thousands)
|
|
|
|
|
December
31,
|
December
31,
|
|
|
|
2018
|
|
2017
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
Cash, cash
equivalents, short-term bank deposits
and restricted cash
|
45,675
|
|
30,438
|
Other accounts
receivable and prepaid expenses
|
903
|
|
741
|
Total current
assets
|
46,578
|
|
31,179
|
|
|
|
|
|
|
Non-current
assets
|
|
|
|
Long-term prepaid
expenses
|
776
|
|
110
|
Severance pay
fund
|
|
2,454
|
|
2,810
|
Property and
equipment, net
|
3,372
|
|
4,647
|
Total non-current
assets
|
6,602
|
|
7,567
|
|
|
|
|
|
|
Total
assets
|
|
53,180
|
|
38,746
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
Other accounts
payable, accrued expenses
and trade payables
|
8,900
|
|
6,194
|
Deferred
participation in R&D expenses
|
1,089
|
|
-
|
Total current
liabilities
|
9,989
|
|
6,194
|
|
|
|
|
|
|
Non-current
liabilities
|
|
|
|
Long-term deferred
participation in R&D expenses
|
3,003
|
|
-
|
Accrued severance
pay
|
2,945
|
|
3,255
|
Total non-current
liabilities
|
5,948
|
|
3,255
|
|
|
|
|
|
|
Total
shareholders' equity
|
37,243
|
|
29,297
|
Total liabilities
and shareholders' equity
|
53,180
|
|
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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SOURCE Compugen Ltd.