HOLON, Israel, May 20, 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 first
quarter ended March 31, 2019.
"2019 continues to be marked by strong execution and we
anticipate reaching additional important milestones in the second
half of the year," said Anat
Cohen-Dayag, Ph.D., President and CEO of Compugen. "Patient
recruitment and site engagement in our Phase 1 study for COM701 are
progressing as planned, and we now have 10 leading sites
participating in our study. Enrollment in the monotherapy dose
escalation arm is expected to be completed by the end of the third
quarter, clearing the way for us to begin enrolling patients in the
monotherapy expansion cohorts later this year. In addition, based
on the progress made in the COM701 monotherapy dose escalation
arm, we are confident in moving forward with
the combination dose escalation arm of the study for which we
expect to complete enrollment this year."
"In parallel, we are also advancing our earlier stage pipeline
focused on first-in-class molecules modulating immuno-suppressive
cells in the tumor microenvironment, mainly cells from the myeloid
lineage, as well as pursuing discovery efforts targeted at
identifying proteins and pathways which are involved
in immune resistance mechanisms to PD-1 therapies. Our goal is
to generate a sustainable pipeline to ensure we have high potential
first-in-class assets in addition to COM701, both for internal
development as well as for additional partnering
opportunities."
Recent Corporate Highlights
- Dosed first patient in the combination arm of Phase 1 study,
combining escalating doses of COM701 with a fixed dose of
Opdivo® (nivolumab) in patients with advanced solid
tumors. Combination arms of the study are conducted under the
clinical collaboration agreement signed with Bristol-Myers Squibb
in October 2018.
- Presented trial-in-progress posters at the ASCO-SITC Clinical
Immuno-Oncology Symposium in January and the 2019 AACR annual
meeting in April. At AACR, the Company reported that the fifth dose
level patient cohort of COM701 monotherapy has been completed and
that no dose-limiting toxicities were found. Clinical and
laboratory assessment for safety and tolerability are ongoing for
this and earlier dose level patient cohorts.
- Awarded by the U.S. Patent and Trademark Office U.S. Patent No.
10,213,505, which covers the composition comprising the COM701 and
the backup antibodies and U.S. Patent No. 10,227,408, which covers
composition comprising an anti-PVRIG antibody having CDRs of COM701
and backup antibodies.
- Published two peer-reviewed papers in Cancer Immunology
Research demonstrating the role of PVRIG as a novel immune
checkpoint target for cancer immunotherapy.
Financial Results
Revenues for the first quarter of 2019 were $0, compared with $10
million in the comparable period of 2018. The revenues for
the first quarter of 2018 reflect the upfront payment of
$10 million from the license agreement with
MedImmune/AstraZeneca.
R&D expenses for the first quarter ended March 31, 2019 were $6.3
million, compared with $7.1
million for the comparable period in 2018. The decrease in
R&D expenses is attributed to the cost reduction measures
announced by the Company during the first quarter of 2019. Further
reduction in expenses will be reflected over the course of
2019.
Net loss for the first quarter of 2019 was $8.4 million, or $0.14 per basic and diluted share, compared with
a net income of $0.1 million, or
$0.0 per basic and diluted share, in
the comparable period of 2018.
As of March 31, 2019, cash, cash
related accounts, short-term and long-term bank deposits totaled
$38.2 million, compared with
$45.7 million at December 31, 2018. During the three months ended
March 31, 2019, the Company sold
approximately 961,000 ordinary shares under its "at-the-market"
(ATM) facility pursuant to a sales agreement entered into with
Cantor Fitzgerald & Co. in May
2018 for aggregate proceeds of $3.4
million, net of commissions to Cantor and expenses related
to the offering. The Company has no debt.
Conference Call and Webcast Information
Compugen will hold a conference call to discuss its first
quarter 2019 results today, May 20,
2019, at 8:30 a.m. ET. To
access the live conference call by telephone, please dial
1-888-668-9141 from the U.S., or +972-3-918-0687 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.
About Compugen
Compugen is a clinical-stage, therapeutic discovery and
development company utilizing its broadly applicable computational
discovery platforms 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
computationally, including T cell immune checkpoints and other
early-stage immuno-oncology programs focused largely on myeloid
targets. Compugen's business model is to 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 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. 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.
(Tables to follow)
COMPUGEN
LTD.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(U.S. dollars in
thousands, except for share and per-share amounts)
|
|
|
|
|
Three Months
Ended
|
|
|
|
March
31,
|
|
|
|
2019
|
|
2018
|
|
|
|
Unaudited
|
|
Unaudited
|
|
|
|
|
|
|
Revenues
|
|
-
|
|
10,000
|
Cost of
revenues
|
|
-
|
|
350
|
Gross
profit
|
|
-
|
|
9,650
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
Research and
development expenses, net
|
6,335
|
|
7,068
|
Marketing and
business development expenses
|
213
|
|
378
|
General and
administrative expenses
|
1,966
|
|
2,089
|
Total operating
expenses
|
8,514
|
|
9,535
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income
(loss)
|
|
(8,514)
|
|
115
|
Financing and other
income (expenses), net
|
106
|
|
(11)
|
|
|
|
|
Income (loss)
before taxes on income
|
(8,408)
|
|
104
|
Taxes on
income
|
-
|
|
-
|
Net income
(loss)
|
(8,408)
|
|
104
|
|
|
|
|
|
|
|
Basic and diluted net
income (loss) per ordinary share
|
(0.14)
|
|
0.00
|
Weighted average
number of ordinary shares used in computing basic net income (loss)
per share
|
60,016,734
|
|
51,782,470
|
Weighted average
number of ordinary shares used in computing diluted net income
(loss) per share
|
60,016,734
|
|
51,975,785
|
COMPUGEN
LTD.
CONDENSED
CONSOLIDATED BALANCE SHEETS DATA
|
(U.S. dollars, in
thousands)
|
|
|
|
|
March 31,
|
December
31,
|
|
|
|
2019
|
|
2018
|
|
|
|
Unaudited
|
|
Audited
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
Cash, cash
equivalents, short-term bank deposits and restricted
cash
|
38,154
|
|
45,675
|
Other accounts
receivable and prepaid expenses
|
1,528
|
|
903
|
Total current
assets
|
39,682
|
|
46,578
|
|
|
|
|
|
|
Non-current
assets
|
|
|
|
Long-term prepaid
expenses
|
779
|
|
776
|
Severance pay
fund
|
|
2,585
|
|
2,454
|
Right to use
Asset
|
|
4,758
|
|
-
|
Property and
equipment, net
|
3,081
|
|
3,372
|
Total non-current
assets
|
11,203
|
|
6,602
|
|
|
|
|
|
|
Total
assets
|
|
50,885
|
|
53,180
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
Other account
payables, accrued expenses and trade payables
|
5,571
|
|
8,900
|
Current maturity of
lease liability
|
1,142
|
|
-
|
Short term deferred
participation in R&D expenses
|
1,053
|
|
1,089
|
Total current
liabilities
|
7,766
|
|
9,989
|
|
|
|
|
|
|
Non-current
liabilities
|
|
|
|
Long term deferred
participation in R&D expenses
|
2,936
|
|
3,003
|
Lease of premises and
vehicles - long term
|
3,799
|
|
-
|
Accrued severance
pay
|
3,103
|
|
2,945
|
Total non-current
liabilities
|
9,838
|
|
5,948
|
|
|
|
|
|
|
Total
shareholders' equity
|
33,281
|
|
37,243
|
Total liabilities
and shareholders' equity
|
50,885
|
|
53,180
|
|
|
|
|
|
|
|
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-first-quarter-2019-results-300853047.html
SOURCE Compugen Ltd.