COM701 MAIA-ovarian trial progressing as planned with median progression-free survival data from the interim analysis expected by Q1 2027
Trial-in-progress poster on MAIA-ovarian presented at the ESMO Gynaecological Cancers Congress 2026, reinforcing the biological and clinical rationale for evaluating COM701 in platinum-sensitive ovarian cancer
Partner AstraZeneca presented new data at ASCO 2026, including the first overall survival readout from the GEMINI-Hepatobiliary study in first-line biliary tract cancer
Gilead-partnered GS-0321 Phase 1 trial continues to progress as planned
Solid financial position with cash runway expected to fund operations into 2029
HOLON, Israel, Aug. 3, 2026 /PRNewswire/ -- Compugen Ltd. $(CGEN)$ (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational drug target discovery powered by AI/ML, today reported financial results for the second quarter of 2026 and provided a corporate update.
"Q2 2026 reflects continued execution across the business," said Eran Ophir, Ph.D., President and CEO of Compugen. "Our MAIA-ovarian trial in platinum-sensitive ovarian cancer remains on track for the interim analysis with median progression-free survival data expected by the first quarter of 2027, which would mark a potential inflection point for COM701 in a patient population with a significant unmet need. Our partnered programs also advanced during the quarter, with AstraZeneca initiating an additional Phase 3 trial with rilvegostomig and presenting new rilvegostomig data at ASCO 2026, and the Gilead-partnered GS-0321 Phase 1 trial progressing as planned. With cash runway expected into 2029, we believe we are well positioned to advance our immuno-oncology pipeline."
COM701
Compugen continues to advance MAIA-ovarian, its sponsored, 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, a setting with no approved treatment option. The Company anticipates the interim analysis with median progression-free survival data by the first quarter of 2027.
During the quarter, Compugen presented a trial-in-progress poster on MAIA-ovarian at the ESMO Gynaecological Cancers Congress in Copenhagen. The poster underscored the strong biological and clinical rationale for evaluating COM701 in this population, including the differentiated biology of the PVRIG pathway versus other checkpoints such as PD-1 and TIGIT, its high expression in ovarian cancer, and the durable responses previously observed with COM701 as mono- and combination therapy in heavily pre-treated platinum-resistant patients. The Company believes that clear prolongation of PFS in these patients versus placebo could inform a registration path for COM701 and establish it as a potential backbone for drug combinations. Clinically meaningful success could also enable a broader clinical development plan across earlier and later lines of ovarian cancer and other indications where clinical signals were previously observed.
Rilvegostomig
Rilvegostomig is a PD-1/TIGIT bispecific antibody being advanced by Compugen's partner AstraZeneca, the TIGIT component of which is derived from Compugen's fully owned COM902 program. At the 2026 ASCO Annual Meeting, AstraZeneca presented an updated analysis from the GEMINI-Hepatobiliary study of rilvegostomig in combination with chemotherapy in the first-line setting. This was the first overall survival readout for rilvegostomig, with median overall survival of 16.8 months, versus less than 13 months in historical first-line biliary tract cancer trials. The data showed encouraging efficacy together with a manageable safety profile in a setting of high unmet need, while longer follow-up and randomized data from the ongoing Phase 3 trial will ultimately be needed to validate these findings. AstraZeneca continues to advance rilvegostomig across its broad late-stage program in 12 ongoing Phase 3 trials, including the recently initiated trial of rilvegostomig in combination with Datroway in urothelial carcinoma.
GS-0321
GS-0321, formerly known as COM503, is a potential first-in-class anti-IL-18 binding protein antibody licensed to Gilead that represents a novel antibody approach to harness cytokine biology for the treatment of cancer, potentially overcoming the limitations of direct cytokine administration. The ongoing Phase 1 dose-escalation trial continues to progress as planned.
Early Pipeline
Compugen continues to leverage Unigen$(TM)$, its AI/ML-powered computational discovery platform, to identify novel drug targets and biological pathways grounded in human disease biology. Unigen has already discovered the targets of COM701, COM902, and GS-0321 and we remain committed to identifying and advancing the next generation of immuno-oncology innovation.
Second Quarter 2026 Financial Highlights
-- Cash: As of June 30, 2026, Compugen had approximately $125.3 million in
cash, cash equivalents, short-term bank deposits, and investment in
marketable securities. Compugen expects that its cash and cash-related
balances will be sufficient to fund its operating plans into 2029. This
does not include any additional cash inflows. The Company has no debt.
-- Revenues for the second quarter of 2026 were approximately $2.6 million,
compared to approximately $1.3 million for the comparable period in 2025.
Revenues in the second quarters of 2026 and 2025 reflect the recognition
of portions of both the upfront payment and the IND milestone payment
from the license agreement with Gilead.
-- R&D expenses for the second quarter of 2026 were approximately $6.3
million, compared to approximately $5.6 million in the second quarter of
2025.
-- G&A expenses for the second quarter of 2026 were approximately $2.3
million, compared to approximately $2.2 million in the second quarter of
2025.
-- Net loss for the second quarter of 2026 was approximately $7.0 million,
or $0.07 per basic and diluted share, compared to a net loss of
approximately $7.3 million, or $0.08 per basic and diluted share, in the
second quarter of 2025.
Full financial tables are included below.
Conference Call and Webcast Information
The Company will hold a conference call today, August 3, 2026, at 8:30 AM ET to review its second 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(TM), its AI/ML 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. 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 expectations for COM701 MAIA-ovarian to have median progression-free survival data at the interim analysis by Q1 2027; statements regarding the biological and clinical rationale for evaluating COM701 in platinum-sensitive ovarian cancer and the potential of clear prolongation of PFS in these patients versus placebo to inform a registration path, serve as a backbone for combinations; statements regarding the potential clinical meaningful success of the MAIA-Ovarian trial to enable a broader clinical development across ovarian cancer and other indications; statements regarding AstraZeneca's advancement of its rilvegostomig program; statements regarding the advancement of Phase 1 trial for Gilead-partnered GS-0321; statements to the effect that our cash and cash-related balances will be sufficient to fund our operating plans into 2029. 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: the clinical trials of any product candidates that Compugen, or any current or future collaborators, may develop may fail to satisfactorily demonstrate safety and efficacy to the FDA, and Compugen, or any collaborators, may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of these product candidates; 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; Compugen's approach to the discovery of therapeutic products is based on its proprietary computational target discovery infrastructure, which is unproven clinically; general market, political and economic conditions in the countries in which Compugen operates, including Israel; the effect of the evolving nature of the recent war in Israel; and Compugen does not know whether it will be able to discover and develop additional potential product candidates or products of commercial value. 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.
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 Six Months Ended
June 30, June 30,
---------------------- ----------------------
2026 2025 2026 2025
---------- ---------- ---------- ----------
Unaudited Unaudited Unaudited Unaudited
---------- ---------- ---------- ----------
Revenues 2,602 1,257 4,778 3,541
Cost of revenues 2,694 1,665 4,518 4,065
---------- ---------- ---------- ----------
Gross profit (loss) (92) (408) 260 (524)
---------- ---------- ---------- ----------
Operating expenses
Research and development
expenses 6,308 5,641 13,245 11,414
Marketing and business
development expenses 179 141 313 280
General and
administrative
expenses 2,258 2,239 4,556 4,606
---------- ---------- ---------- ----------
Total operating expenses 8,745 8,021 18,114 16,300
---------- ---------- ---------- ----------
Operating loss (8,837) (8,429) (17,854) (16,824)
Financial and other
income, net 1,838 1,070 3,191 2,315
---------- ---------- ---------- ----------
Loss before taxes on
income (6,999) (7,359) (14,663) (14,509)
Tax benefit (expense) (7) 17 (12) (14)
---------- ---------- ---------- ----------
Net loss (7,006) (7,342) (14,675) (14,523)
========== ========== ========== ==========
Basic and diluted net
loss per ordinary
share (0.07) (0.08) (0.16) (0.16)
Weighted average number
of ordinary shares used
in computing basic and
diluted net loss per
share 94,640,696 93,526,884 94,598,696 92,917,554
COMPUGEN LTD.
CONDENSED CONSOLIDATED BALANCE SHEETS DATA
(U.S. dollars in thousands)
June 30, December 31,
--------- ------------
2026 2025
--------- ------------
Unaudited
---------
ASSETS
Current assets
Cash and cash equivalents 10,280 90,597
Short-term bank deposits 75,338 45,759
Investment in marketable securities 39,682 9,284
Accounts receivable 680 -
Other accounts receivable and prepaid expenses 3,429 2,382
--------- ------------
Total current assets 129,409 148,022
--------- ------------
Non-current assets
Restricted long-term bank deposit 448 410
Long-term prepaid expenses 1,314 1,293
Severance pay fund 4,082 3,643
Operating lease right to use asset 2,422 2,521
Property and equipment, net 690 681
--------- ------------
Total non-current assets 8,956 8,548
--------- ------------
Total assets 138,365 156,570
========= ============
LIABILITIES AND SHAREHOLDERS EQUITY
Current liabilities
Trade payables 2,155 2,353
Short-term deferred revenues 11,456 10,970
Current maturity of operating lease liability 623 521
Accrued expenses 5,255 5,676
Employees and related accruals 3,144 3,050
--------- ------------
Total current liabilities 22,633 22,570
--------- ------------
Non-current liabilities
Long-term deferred revenues 20,360 24,943
Long-term operating lease liability 2,400 2,439
Accrued severance pay 4,238 3,887
--------- ------------
Total non-current liabilities 26,998 31,269
--------- ------------
Total shareholders' equity 88,734 102,731
--------- ------------
Total liabilities and shareholders' equity 138,365 156,570
========= ============
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SOURCE Compugen Ltd.
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