Compugen (NASDAQ:CGEN) said it remains on track to report interim progression-free survival data in the first quarter of 2027 from its MAIA-ovarian study, as the clinical-stage immuno-oncology company outlined first-quarter 2026 results and updates across its internal and partnered programs.
On the company’s first-quarter earnings call, President and Chief Executive Officer Dr. Eran Ophir said 2026 is “shaping up to be a significant year” for Compugen as it advances COM701, its wholly owned antibody targeting PVRIG, and monitors progress on partnered assets with AstraZeneca and Gilead.
COM701 enrollment underway in ovarian cancer maintenance study
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Compugen’s lead wholly owned clinical program, COM701, is being evaluated in the MAIA-ovarian adaptive platform trial as maintenance monotherapy compared with placebo in patients with relapsed platinum-sensitive ovarian cancer who responded to their most recent line of chemotherapy.
Ophir said the company initiated the study based on prior data presented at ESMO, where pooled clinical data showed COM701, as monotherapy and in combinations, was well-tolerated and produced “consistent, durable responses” in heavily pretreated patients with platinum-resistant ovarian cancer.
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The company is now testing COM701 in an earlier ovarian cancer setting, with the rationale that patients may have lower tumor burden and a less compromised immune system, potentially improving the likelihood of benefit from COM701’s mechanism of action.
Ophir said all clinical sites are open and enrolling across the United States, Israel and France. He said that gives the company confidence in its ability to complete enrollment on schedule for interim median progression-free survival data in the first quarter of 2027.
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Chief Medical Officer Dr. Michelle Mahler said during the question-and-answer session that Compugen is not currently commenting on specific enrollment numbers, but remains “on track” for the planned interim analysis. She said the study is stratified by second-line versus third-line treatment, not by PD-L1 status.
Ophir added that prior clinical signals with COM701 have been seen in both PD-L1-positive and PD-L1-negative patients, saying PD-L1 stratification may not be the critical factor for the PVRIG-targeting approach.
Mahler said the benchmark progression-free survival for the control arm, based on prior second- and third-line maintenance studies in similar untreated patient populations, is about 5.5 months, with a range from 3.8 months to 5.8 months. She said Compugen hopes to show “meaningful single agent clinical activity” and has hypothesized that a three-month or greater improvement over benchmark progression-free survival would be meaningful.
Mahler also said the adaptive trial could allow for adjustments after the interim readout, including the possibility of adding arms, depending on the totality of the data and engagement with regulators on potential steps toward a pivotal trial.
AstraZeneca rilvegostomig program continues to expand
Compugen also highlighted progress by AstraZeneca on rilvegostomig, a bispecific antibody program connected to Compugen’s partnered pipeline economics. Ophir said AstraZeneca presented multiple rilvegostomig abstracts at the AACR annual meeting, including preclinical data supporting potential use as an immuno-oncology backbone for combinations and late-breaking data from the DESTINY-Gastric03 phase 2 trial.
That trial evaluated rilvegostomig in combination with ENHERTU and chemotherapy as a first-line treatment for HER2-positive gastric cancers. Ophir said the data showed “promising antitumor activity” and supported the safety combinability of rilvegostomig.
Ophir said AstraZeneca is advancing rilvegostomig in 11 phase 3 trials across multiple indications, including a recently opened gastric cancer trial in combination with a claudin 18.2 antibody-drug conjugate. He also said Compugen expects additional clinical data from AstraZeneca during the year, including at the upcoming ASCO meeting.
In response to an analyst question, Ophir said two clinical datasets are expected at ASCO: one from the I-SPY trial evaluating rilvegostomig in an adjuvant setting with ENHERTU, and another from a German hepatobiliary study in combination with chemotherapy. He cautioned against setting expectations on behalf of AstraZeneca, but said safety and combinability would be important areas to watch.
Compugen said AstraZeneca has previously estimated non-risk-adjusted peak annual revenue potential of more than $5 billion for rilvegostomig. Compugen is eligible for up to $995 million in additional regulatory and commercial milestone payments, plus mid-single-digit tiered royalties on sales.
Gilead-partnered GS-0321 remains in phase 1
Ophir said GS-0321, formerly known as COM503, continues to progress as planned in an ongoing phase 1 dose-escalation trial. The asset is a potential first-in-class anti-IL-18 binding protein antibody licensed to Gilead.
Compugen has received $90 million to date from Gilead for the program and remains eligible for up to $758 million in additional milestone payments, plus up to double-digit tiered royalties, according to the company.
Ophir said GS-0321 reflects Compugen’s strategy of using its AI-powered computational discovery platform, Unigen, to identify novel immuno-oncology approaches. He said Unigen discovered the targets for COM701, COM902 and GS-0321.
First-quarter financial results
Chief Financial Officer David Silberman said Compugen ended the first quarter with about $134.9 million in cash equivalents, short-term bank deposits and investments in marketable securities as of March 31, 2026.
The company said its cash runway, assuming no further cash inflows, is expected to fund operating plans into 2029. Ophir and Silberman both referenced a December 2025 transaction with AstraZeneca that brought in $65 million in non-dilutive capital through the monetization of a small portion of future rilvegostomig royalties.
Revenue: First-quarter 2026 revenue was approximately $2.2 million, compared with approximately $2.3 million in the prior-year period. The revenue in both periods reflected recognition related to the upfront payment and R&D milestone payment from the Gilead license agreement.
Research and development expenses: R&D expenses were approximately $6.9 million, up from approximately $5.8 million in the first quarter of 2025, mainly due to higher clinical expenses related to the MAIA-ovarian trial and drug supply costs.
General and administrative expenses: G&A expenses were approximately $2.3 million, compared with approximately $2.4 million a year earlier.
Net loss: The company reported a net loss of approximately $7.7 million, or $0.08 per basic and diluted share, compared with a net loss of approximately $7.2 million, or $0.08 per basic and diluted share, in the first quarter of 2025.
Silberman said the company expects to use its runway to advance the COM701 MAIA-ovarian study, support the progression of GS-0321 with Gilead and continue investing in its early-stage pipeline.
About Compugen (NASDAQ:CGEN)
Compugen Ltd. (NASDAQ: CGEN) is a clinical-stage therapeutic discovery company that leverages proprietary computational discovery platforms to identify novel immuno-oncology targets and biomarkers. The company combines large-scale biological datasets with machine learning algorithms to generate and validate new therapeutic and diagnostic candidates. Founded in 1993 and headquartered in Tel Aviv, Israel, Compugen also maintains a presence in the United States to support its clinical development and commercial collaborations.
Compugen’s predictive discovery engine scans complex biological systems in silico to reveal previously unrecognized pathways and immune checkpoints involved in cancer progression.
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