Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F:
On November 9, 2026, Compugen Ltd. (the “Company”)
issued a press release reporting the Company’s 2026 third quarter results (the “Press Release”), a copy of which
is furnished as Exhibit 99.1 to this Report on Form 6-K.
With the exception of the quotes attributable
to Eran Ophir, Ph.D., information contained in the Press Release is hereby incorporated by reference into the Company’s Registration
Statement on Form F-3, File No. 333-295989.
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Exhibit 99.1
Compugen Reports
Third Quarter 2026 Results
MAIA-ovarian fully enrolled; results expected
by end of Q1 2027
Phase 3 rilvegostomig high-level
results from partner AstraZeneca anticipated in H2 2027
from ARTEMIDE-Biliary01 trial
UnigenX™ designed to expand AI-powered
discovery engine into tumor-associated antigens for
targeted immune activation modalities
Cash runway expected into 2029
HOLON, Israel, November 9, 2026 /PRNewswire/ - Compugen Ltd.
(NASDAQ: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational drug target discovery powered
by AI, today reported financial results for the third quarter of 2026 and provided a corporate update.
“During the third quarter, we continued to advance COM701 and
GS-0321 in the clinic, as well as build the next generation of our pipeline,” said Eran Ophir, Ph.D., President and Chief Executive
Officer of Compugen. “MAIA-ovarian is now fully enrolled, and we remain on track to report results by the end of the first quarter
of 2027.We are also excited to see partner AstraZeneca continue to progress rilvegostomig, with Phase 3 high-level trial results from
ARTEMIDE-Biliary01 anticipated in the second half of 2027. In addition, we introduced UnigenX™, which expands our discovery
capabilities into novel tumor-associated antigens, that could enable specific tumor targeting of potent therapeutic modalities such as
T cell engagers. With cash runway expected into 2029, we believe we are well positioned to execute on our strategy and look forward to
2027, which we expect to be a data-rich year.”
COM701
Compugen has completed enrollment in its MAIA-ovarian, its global,
randomized, placebo-controlled adaptive platform trial evaluating COM701, a potential first-in-class anti-PVRIG antibody, as maintenance
monotherapy in patients with second- and third-line relapsed platinum-sensitive ovarian cancer. The Company remains on track to report
results by the end of the first quarter of 2027.
The blinded trial enrolled 62 patients randomized two to one to receive
either COM701 or placebo. MAIA-ovarian was designed to evaluate COM701 in a setting with no approved maintenance treatment option and
significant unmet need.
At Compugen’s October 5, 2026, virtual key opinion leader event,
Dr. Yeku of Harvard Medical School and Massachusetts General Hospital discussed the importance of extending the platinum-free interval
in patients with relapsed platinum-sensitive ovarian cancer, the limitations of currently available maintenance options and the need to
balance efficacy, tolerability and treatment sequencing.
In evaluating the MAIA-ovarian trial, Compugen intends to consider
the totality of the data, including the magnitude and durability of separation between the COM701 and placebo arms and the proportion
of patients remaining progression-free at six months. COM701 has the potential to serve as an important maintenance option for patients
with relapsed platinum sensitive ovarian cancer who currently have very limited therapeutic alternatives.
Rilvegostomig
Rilvegostomig is an AstraZeneca-owned PD-1/TIGIT bispecific antibody
whose TIGIT component is derived from Compugen's COM902. Compugen is eligible to receive up to $195 million in additional regulatory and
commercial milestone payments, as well as up to mid-single- digit tiered royalties on future sales, under its license agreement with AstraZeneca.
In September 2026, AstraZeneca reported the first overall survival
data from the Phase 2 ARTEMIDE-01 trial in first-line, checkpoint inhibitor- and chemotherapy-naïve patients with PD-L1-positive
non-small cell lung cancer. Median overall survival compared favorably with historical controls.
The Phase 3 high-level results from the clinical trial ARTEMIDE-Biliary01
studying rilvegostomig are now anticipated in the second half of 2027. ARTEMIDE-Biliary01 is assessing rilvegostomig plus investigator’s
choice of chemotherapy compared to chemotherapy only as adjuvant treatment in 760 participants with biliary tract cancer who are at risk
of recurrence after resection with curative intent. Rilvegostomig is being evaluated in 12 ongoing Phase 3 trials across indications including
non-small cell lung cancer, biliary tract cancer and gastric cancer.
GS-0321
GS-0321, formerly known as COM503, is a potential first-in-class anti-IL-18
binding protein antibody licensed to Gilead. The program is designed to harness cytokine biology for the treatment of cancer while potentially
overcoming limitations associated with direct cytokine administration.
The ongoing Phase 1 dose-escalation trial is continuing to advance.
Compugen has received gross payments totaling $90 million from Gilead
under the license agreement and is eligible to receive up to $758 million in additional milestone payments, plus tiered royalties ranging
from single digits to low double digits.
Early Pipeline
Unigen™ is Compugen’s AI-powered discovery engine
for identifying novel immuno-oncology drug targets by connecting computational prediction, biological validation and clinical learning.
Unigen™ has enabled the discovery of TIGIT, PVRIG and IL-18BP as drug targets, which have all progressed to clinical stage.
At its October 5, 2026, investor event, Compugen introduced UnigenX™,
a strategic expansion into targeted immune activation modalities such as T cell engagers, which can identify single targets and target
pairs. Compugen intends to apply UnigenX™ to discover novel tumor-associated antigens that could enable more selective immune
targeting of tumor cells.
This expanded capability is intended to support the next generation
of Compugen’s early-stage pipeline.
Third Quarter 2026 Financial Highlights
| · | Cash: As of September 30, 2026, Compugen had approximately $117.5
million in cash, cash equivalents, short-term bank deposits and investments in marketable securities. Compugen expects its cash and cash-related
balances to be sufficient to fund its operating plans into 2029. This does not include any additional cash inflows. |
| · | Revenues for the third quarter of 2026 were approximately $3.8 million,
compared with approximately $1.9 million for the comparable period in 2025. Revenues in the third quarters of 2026 and 2025 reflect the
recognition of portions of both the upfront payment and the investigational new drug milestone payment under the license agreement with
Gilead. |
| · | Research and development expenses were approximately $5.8 million
for each of the third quarters of 2026 and 2025. |
| · | General and administrative expenses for the third quarter of 2026
were approximately $2.3 million, compared with approximately $2.2 million in the third quarter of 2025. |
| · | Net loss for the third quarter of 2026 was approximately $5.8 million,
or $0.06 per basic and diluted share, compared with a net loss of approximately $7.0 million, or $0.07 per basic and diluted share, in
the third quarter of 2025. |
Conference Call and Webcast Information
The Company will hold a conference call today, November 9, 2026, at
8:30 AM ET to review its third quarter 2026 results. To access the conference call by telephone, please dial 1-866-744-5399 from the United
States, 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 Unigen™, its AI-powered computational discovery platform, to identify novel drug targets and to develop therapeutics
in the field of cancer immunotherapies. Compugen's innovative immuno-oncology pipeline consists of COM701, rilvegostomig and GS-0321
(previously COM503). COM701, a potential first-in-class anti-PVRIG antibody, is currently being evaluated in a blinded randomized ovarian
cancer adaptive platform trial as a single agent in maintenance therapy in relapsed platinum-sensitive ovarian cancer (named MAIA-ovarian
trial). Rilvegostomig, a PD-1/TIGIT bispecific antibody with a TIGIT component that is derived from COM902, Compugen's anti-TIGIT antibody,
is being developed by AstraZeneca pursuant to an exclusive license agreement between Compugen and AstraZeneca and is being evaluated
in multiple Phase 3, Phase 2 and Phase 1 clinical trials. GS-0321 (previously COM503), Compugen's potential first-in-class high affinity
antibody, which blocks the interaction between IL-18 binding protein and IL-18, is licensed to Gilead and is being evaluated in
a Phase 1 clinical trial that Compugen is conducting. In addition, Compugen has an early-stage immuno-oncology pipeline that consists
of research programs aiming to address various mechanisms to enhance anti-cancer immunity. 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. These forward-looking statements are based on the current beliefs, expectations
and assumptions of Compugen.
Forward-looking statements can be identified by terminology such as
“will,” “may,” “expects,” “anticipates,” “believes,” “potential,”
“plans,” “goal,” “estimate,” “likely,” “should,” “confident,”
“intends” and similar expressions 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 the expected timing of data from MAIA-ovarian and ARTEMIDE-Biliary01; the potential clinical activity, benefits and development
opportunities for COM701; assumptions regarding progression-free survival in the placebo arm of MAIA-ovarian; AstraZeneca’s advancement
of rilvegostomig and the expected reporting of additional clinical data; the advancement of the Phase 1 trial for Gilead-partnered GS-0321;
potential milestone and royalty payments under Compugen’s agreements with AstraZeneca and Gilead; the potential of Unigen™
and UnigenX™ to identify novel targets and support future pipeline programs; and Compugen’s expectation that its cash
and cash-related balances will be sufficient to fund its operating plans into 2029.
These forward-looking statements involve known and unknown risks and
uncertainties that may cause Compugen’s actual results, performance or achievements to differ materially from any future results,
performance or achievements expressed or implied by such statements. Among these risks are that clinical trials of product candidates
that Compugen or its collaborators may develop may fail to satisfactorily demonstrate safety and efficacy to applicable regulatory authorities;
Compugen or its collaborators may incur additional costs or experience delays in completing, or ultimately be unable to complete, the
development and commercialization of product candidates; Compugen’s business model is substantially dependent on 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 therapeutic discovery is based on proprietary computational discovery capabilities that remain subject to
scientific and clinical validation; general market, political and economic conditions in the countries in which Compugen operates, including
Israel, may adversely affect its business; and Compugen may not be able to discover and develop additional product candidates or products
of commercial value.
These and other risks are more fully discussed in the “Risk Factors”
section of Compugen’s most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission, as well as other
documents that may subsequently be filed by Compugen with the SEC.
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
Lindsey Trickett
Head of Investor Relations and Corporate Communications
Email: lindseyt@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 | | |
Nine Months Ended | |
| | |
September 30, | | |
September 30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| | |
Unaudited | | |
Unaudited | | |
Unaudited | | |
Unaudited | |
| | |
| | |
| | |
| | |
| |
| Revenues | |
| 3,821 | | |
| 1,891 | | |
| 8,599 | | |
| 5,432 | |
| Cost of revenues | |
| 2,400 | | |
| 1,650 | | |
| 6,918 | | |
| 5,715 | |
| Gross profit (loss) | |
| 1,421 | | |
| 241 | | |
| 1,681 | | |
| (283 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Operating expenses | |
| | | |
| | | |
| | | |
| | |
| Research and development expenses | |
| 5,842 | | |
| 5,800 | | |
| 19,087 | | |
| 17,214 | |
| Marketing and business development expenses | |
| 150 | | |
| 139 | | |
| 463 | | |
| 419 | |
| General and administrative expenses | |
| 2,275 | | |
| 2,195 | | |
| 6,831 | | |
| 6,801 | |
| Total operating expenses | |
| 8,267 | | |
| 8,134 | | |
| 26,381 | | |
| 24,434 | |
| | |
| | | |
| | | |
| | | |
| | |
| Operating loss | |
| (6,846 | ) | |
| (7,893 | ) | |
| (24,700 | ) | |
| (24,717 | ) |
| Financial and other income, net | |
| 1,054 | | |
| 954 | | |
| 4,245 | | |
| 3,269 | |
| Loss before taxes on income | |
| (5,792 | ) | |
| (6,939 | ) | |
| (20,455 | ) | |
| (21,448 | ) |
| Tax benefit (expense) | |
| (8 | ) | |
| (40 | ) | |
| (20 | ) | |
| (54 | ) |
| Net loss | |
| (5,800 | ) | |
| (6,979 | ) | |
| (20,475 | ) | |
| (21,502 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Basic and diluted net loss per ordinary share | |
| (0.06 | ) | |
| (0.07 | ) | |
| (0.22 | ) | |
| (0.23 | ) |
| Weighted average number of ordinary shares used in computing basic and diluted net loss per share | |
| 94,768,232 | | |
| 93,538,565 | | |
| 94,655,052 | | |
| 93,124,558 | |
| COMPUGEN LTD. |
| CONDENSED CONSOLIDATED BALANCE SHEETS DATA |
| (U.S. dollars, in thousands) |
| |
|
|
|
| | |
September 30, | | |
December 31, | |
| | |
2026 | | |
2025 | |
| | |
Unaudited | | |
| |
| ASSETS | |
| | | |
| | |
| | |
| | | |
| | |
| Current assets | |
| | | |
| | |
| Cash and cash equivalents | |
| 7,061 | | |
| 90,597 | |
| Short-term bank deposits | |
| 95,194 | | |
| 45,759 | |
| Investment in marketable securities | |
| 15,273 | | |
| 9,284 | |
| Other accounts receivable and prepaid expenses | |
| 3,247 | | |
| 2,382 | |
| Total current assets | |
| 120,775 | | |
| 148,022 | |
| | |
| | | |
| | |
| Non-current assets | |
| | | |
| | |
| Restricted long-term bank deposit | |
| 456 | | |
| 410 | |
| Long-term prepaid expenses | |
| 1,321 | | |
| 1,293 | |
| Severance pay fund | |
| 4,009 | | |
| 3,643 | |
| Operating lease right to use asset | |
| 2,299 | | |
| 2,521 | |
| Property and equipment, net | |
| 674 | | |
| 681 | |
| Total non-current assets | |
| 8,759 | | |
| 8,548 | |
| | |
| | | |
| | |
| Total assets | |
| 129,534 | | |
| 156,570 | |
| | |
| | | |
| | |
| LIABILITIES AND SHAREHOLDERS’ EQUITY | |
| | | |
| | |
| | |
| | | |
| | |
| Current liabilities | |
| | | |
| | |
| Trade payables | |
| 1,369 | | |
| 2,353 | |
| Short-term deferred revenues | |
| 12,846 | | |
| 10,970 | |
| Current maturity of operating lease liability | |
| 613 | | |
| 521 | |
| Accrued expenses | |
| 6,475 | | |
| 5,676 | |
| Employees and related accruals | |
| 3,353 | | |
| 3,050 | |
| Total current liabilities | |
| 24,656 | | |
| 22,570 | |
| | |
| | | |
| | |
| Non-current liabilities | |
| | | |
| | |
| Long-term deferred revenues | |
| 15,183 | | |
| 24,943 | |
| Long-term operating lease liability | |
| 2,177 | | |
| 2,439 | |
| Accrued severance pay | |
| 4,155 | | |
| 3,887 | |
| Total non-current liabilities | |
| 21,515 | | |
| 31,269 | |
| | |
| | | |
| | |
| Total shareholders' equity | |
| 83,363 | | |
| 102,731 | |
| | |
| | | |
| | |
| Total liabilities and shareholders' equity | |
| 129,534 | | |
| 156,570 | |
