- Triple blockade of PVRIG/TIGIT/PD-1 may be required to optimize
clinical responses
- COM701, a unique check point inhibitor, with potential to
recruit additional T cells to the TME
- COM902 has the potential to be a best-in-class anti-TIGIT
antibody
- On track to deliver clinical data from the cohort expansion
study of COM701/nivolumab in MSS CRC in Q4 2022
- Enrollment continues in the Phase 1 clinical studies for COM701
and COM902
- Cash balance of $107 million
affirms focus on capital efficiency with bold execution on
Compugen's DNAM-1 axis hypothesis
HOLON, Israel, May 16, 2022
/PRNewswire/ -- Compugen Ltd. (NASDAQ: CGEN), a clinical-stage
cancer immunotherapy company and a pioneer in computational target
discovery, announced today financial results for the first quarter
ended March 31, 2022 and provided a
corporate update on key events since the start of 2022.
"I am excited about the outlook of Compugen's immune checkpoint
inhibitors based on their unique characteristics, encouraging
preliminary clinical data and our differentiated clinical
development strategy," said Anat
Cohen-Dayag, Ph.D., President, and Chief Executive Officer
of Compugen. We are the first to evaluate the triple blockade of
the DNAM-1 axis, targeting PVRIG, TIGIT and PD-1 in the clinic.
Based on the totality of the data we have to date on the PVRIG
pathway, we believe triple blockade of PVRIG/TIGIT/PD-1 may be
required for optimizing clinical responses in both inflamed and
less inflamed tumors where other checkpoint inhibitors have so far
been unsuccessful. Our Phase 1 clinical data demonstrated durable
disease control rates, consistent immune activation, and good
tolerability. With COM902, we are the first company to present
clinical data with an IgG4 anti-TIGIT antibody, with low
Fc-effector function. Having over a decade of expertise in this
space, we believe this is the optimal design for an anti-TIGIT
antibody. COM902 achieved a disease control rate of 50%. Unlike
some other anti-TIGIT antibodies, to date studies have shown that
COM902 avoids depletion of the CD8+ T cells, crucial for efficacy
and we believe the IgG4 backbone may come with additional safety
benefits. We look forward to proving our DNAM-1 axis hypothesis
through our robust differentiated clinical strategy with studies
designed to maximize the potential of COM701."
Dr. Cohen-Dayag also commented, "Continuing on our excellent
track record in execution, our first quarter of 2022 has been
focused on execution of our differentiated clinical strategy to
further enhance our leadership in DNAM-1 axis evaluation.
Enrollment continues in our well designed, comprehensive Phase 1
clinical studies with our pioneering immunotherapy drug candidates
COM701, targeting PVRIG, and COM902, targeting TIGIT. In addition,
we continue to be data-driven, invest in cutting edge research and
innovate as reflected by presentations at the AACR and Keystone
Symposium as well as expansion of COM701 intellectual property
portfolio with a new U.S. patent covering triple combination use
with anti-PD-1 and anti-TIGIT antibodies. Our $107 million cash balance affirms our financial
discipline, with bold execution on our DNAM-1 axis hypothesis."
Dr. Cohen-Dayag continued, "Our clinical program is comprised of
three ongoing cohort expansion combination studies, with
overlapping indications, in patients with relapsed disease and
indications so far insensitive to immunotherapy. The program was
designed to focus on patients with limited treatment options and
indications with greatest unmet need to efficiently demonstrate
proof-of-concept for our novel immune therapies. Our intention is
to report data from fully enrolled cohorts of each of these
studies, taking into consideration that certain cohorts/indications
enroll faster than others. We are on track to provide results from
these studies starting with the microsatellite stable colorectal
cancer, COM701/nivolumab combination expansion cohort, in the
fourth quarter of 2022. We are also planning to report results from
the other cohorts throughout 2023. The data from these studies will
guide our regulatory strategy on a cohort-by-cohort basis."
Dr. Cohen-Dayag concluded, "We are committed and we look forward
to updating the medical and investment communities with our
progress."
Financial Results
As of March
31, 2022, cash, cash equivalents, short-term bank deposits
and restricted cash totaled approximately $107 million, compared with approximately
$118 million as of December 31, 2021. The Company expects its
existing cash and cash related balances to be sufficient to fund
its operating plan into 2024, at the current rate of expenses.
Compugen does not have any debt.
R&D expenses for the first quarter ended March 31, 2022, were approximately $7.2 million compared with approximately
$7.3 million for the comparable
period in 2021.
General and administrative expenses for the first quarter ended
March 31, 2022, were approximately
$2.6 million compared with
approximately $2.7 million for the
comparable period in 2021.
Net loss for the first quarter ended March 31, 2022, was approximately $9.7 million, or $0.11 per basic and diluted share, compared with
a net loss of approximately $9.9
million, or $0.12 per basic
and diluted share, in the comparable period of 2021.
About Compugen
Compugen is a clinical-stage
therapeutic discovery and development company utilizing its broadly
applicable predictive computational discovery capabilities to
identify new drug targets and biological pathways for
developing cancer immunotherapies. Compugen has developed two
proprietary product candidates: COM701, a potential first-in-class
anti-PVRIG antibody, for the treatment of solid tumors,
in Phase 1 as a single agent and in dual, and triple
combinations; COM902, a potential best-in-class monoclonal
antibody targeting TIGIT for the treatment of solid and
hematological tumors, undergoing Phase 1 studies as a single agent
and in dual combination with COM701. Partnered programs include
bapotulimab, an antibody targeting ILDR2, in Phase 1 development,
licensed to Bayer under a research and discovery collaboration and
license agreement, and a TIGIT/PD-1 bispecific derived from COM902
(AZD2936) in Phase 1/2 development by AstraZeneca through a license
agreement for the development of bispecific and multi-specific
antibodies. In addition, the Company's therapeutic pipeline of
early-stage immuno-oncology programs consists of programs
aiming to address various mechanisms of immune resistance,
including 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.
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 regarding our belief that triple blockade of
PVRIG/TIGIT/PD-1 may be required for optimizing clinical responses
in both inflamed and less inflamed tumors where other
checkpoint inhibitors have so far been unsuccessful; our belief
that IgG4 anti-TIGIT antibody is the optimal design for an
anti-TIGIT antibody; our belief that the IgG4 backbone may express
additional safety benefits in addition to preventing the depletion
of the CD8+ T cells; and our expectation that existing cash and
cash related balances will be sufficient to fund our operating
plan into 2024. 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: In
the near term, Compugen is highly dependent on the success of
COM701 and of COM902; Compugen may not be able to advance its
internal clinical stage programs through clinical development or
manufacturing or successfully partner or commercialize them, or
obtain marketing approval, either alone or with a collaborator, or
may experience significant delays in doing so; 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 trials for any specific product or may not be
able to conduct or complete its trials on the timelines it expects;
Compugen has limited experience in the development of therapeutic
product candidates, and it may be unable to implement its business
strategy. 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.
Investor Relations contact:
Yvonne Naughton, Ph.D.
Head of Investor Relations and Corporate Communications Compugen
Ltd.
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
|
|
|
|
March
31,
|
|
|
|
2022
|
|
2021
|
|
|
|
Unaudited
|
|
Unaudited
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
|
Research and
development expenses
|
7,170
|
|
7,326
|
|
|
Marketing and business
development
expenses
|
223
|
|
224
|
|
|
General and
administrative expenses
|
2,603
|
|
2,714
|
|
|
Total operating
expenses
|
9,996
|
|
10,264
|
|
|
Financial and other
income, net
|
286
|
|
359
|
|
|
Loss before taxes on
income
|
(9,710)
|
|
(9,905)
|
|
|
Taxes on
income
|
-
|
|
-
|
|
|
Net
loss
|
(9,710)
|
|
(9,905)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per ordinary share
|
(0.11)
|
|
(0.12)
|
|
|
Weighted average number
of ordinary shares
used in computing basic and diluted net loss
per share
|
86,454,510
|
|
83,680,332
|
|
|
|
|
|
|
|
|
|
|
COMPUGEN
LTD.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS DATA
|
(U.S. dollars, in
thousands)
|
|
|
|
|
|
March
31,
|
|
December
31,
|
|
|
2022
|
|
2021
|
|
|
Unaudited
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
Cash, cash equivalents,
short-term bank deposits and restricted cash
|
106,821
|
|
117,762
|
|
Other accounts
receivable and prepaid expenses
|
5,302
|
|
5,460
|
|
Total current
assets
|
112,123
|
|
123,222
|
|
|
|
|
|
|
Non-current
assets
|
|
|
|
|
Long-term prepaid
expenses
|
1,917
|
|
1,911
|
|
Severance pay
fund
|
3,110
|
|
3,125
|
|
Operating lease right
to use asset
|
2,118
|
|
2,247
|
|
Property and equipment,
net
|
1,665
|
|
1,658
|
|
Total non-current
assets
|
8,810
|
|
8,941
|
|
|
|
|
|
|
Total
assets
|
120,933
|
|
132,163
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
SHAREHOLDERS EQUITY
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
Other accounts payable,
accrued expenses and trade payables
|
11,446
|
|
12,699
|
|
Current maturity of
operating lease liability
|
764
|
|
768
|
|
Short-term deferred
participation in R&D expenses
|
3,493
|
|
3,629
|
|
Total current
liabilities
|
15,703
|
|
17,096
|
|
|
|
|
|
|
Non-current
liabilities
|
|
|
|
|
Long-term deferred
participation in R&D expenses
|
1,651
|
|
2,715
|
|
Long-term operating
lease liability
|
1,772
|
|
1,982
|
|
Accrued severance
pay
|
3,657
|
|
3,677
|
|
Total non-current
liabilities
|
7,080
|
|
8,374
|
|
|
|
|
|
|
Total shareholders'
equity
|
98,150
|
|
106,693
|
|
|
|
|
|
|
Total liabilities
and shareholders' equity
|
120,933
|
|
132,163
|
|
|
|
|
|
|
View original
content:https://www.prnewswire.com/news-releases/compugen-reports-first-quarter-2022-results-301547696.html
SOURCE Compugen Ltd.