Compugen (NASDAQ:CGEN) said its second-quarter 2026 progress included continued enrollment in its MAIA-ovarian study of COM701, advancing partner-led programs with AstraZeneca and Gilead, and a cash runway projected to extend into 2029.
President and Chief Executive Officer Eran Ophir described the quarter as one of “steady advancement,” citing progress across the company’s clinical programs, collaborations and early-stage discovery activities.
MAIA-Ovarian Interim Analysis Targeted by First Quarter of 2027
The company expects an interim analysis containing median progression-free survival data by the first quarter of 2027. Ophir said Compugen presented a trial-in-progress poster at the ESMO Gynaecological Cancers Congress that outlined the biological and clinical rationale for COM701, including PVRIG’s differentiated biology relative to PD-1 and TIGIT, its expression in ovarian cancer, and prior observations of durable responses in heavily pretreated platinum-resistant patients.
Compugen now estimates that median progression-free survival in MAIA-ovarian’s placebo arm could be approximately four months. Chief Medical Officer Michelle Mahler said the estimate reflects emerging results from the European TADPOLE and ORION studies, whose placebo arms showed median progression-free survival of 2.8 months in more heavily pretreated patient populations.
Those external studies allowed patients with stable disease, liver metastases and multiple prior treatments with bevacizumab or PARP inhibitors, Mahler said. Compugen’s prior benchmark had been based on older PARP inhibitor registration studies, where median progression-free survival was approximately five and a half months.
Management said the MAIA-ovarian trial remains blinded and that the ultimate assessment will compare 40 patients receiving COM701 monotherapy with 20 patients in the placebo arm. The company defines clinically meaningful success at the interim analysis as helping patients remain progression-free for at least six months following platinum-based chemotherapy.
Ophir said a clear prolongation of progression-free survival could inform a registration path for COM701, though MAIA is exploratory and is not powered as a registrational trial to demonstrate a statistical difference between treatment groups.
During the question-and-answer session, Mahler said Compugen has not yet met with the FDA regarding whether MAIA-ovarian alone could support an expedited or accelerated approval path. She said the study design incorporated FDA guidance, including elements aligned with Project FrontRunner and Bayesian trial-design recommendations.
AstraZeneca Expands Rilvegostomig Development
AstraZeneca is advancing rilvegostomig, a PD-1/TIGIT bispecific antibody whose TIGIT component is derived from Compugen’s COM902 program. Ophir said AstraZeneca recently added a 12th phase III rilvegostomig trial, TROPION-Urothelial-04, in high-risk muscle-invasive urothelial carcinoma.
That trial will evaluate rilvegostomig combined with Dato-DXd in the adjuvant setting against standard of care. Compugen said the study follows phase II data from TROPION-PanTumor03, in which the combination showed encouraging efficacy and manageable safety in metastatic urothelial carcinoma.
Ophir also highlighted updated data from AstraZeneca’s GEMINI-Hepatobiliary study in first-line advanced biliary tract cancer. The reported overall survival figure was 16.8 months for rilvegostomig in combination with chemotherapy, compared with historical first-line studies cited by Compugen showing survival of less than 13 months. The company noted that longer follow-up and randomized phase III data will be needed to validate the findings.
AstraZeneca has previously guided to non-risk-adjusted peak-year revenue potential of more than $5 billion for rilvegostomig, according to Compugen. Compugen remains eligible for $195 million in future milestones and up to mid-single-digit tiered royalties. Management said AstraZeneca’s formal guidance places phase III readouts after 2027, while noting interim analyses could potentially occur earlier.
Gilead Program and Financial Position
Compugen said Gilead’s phase I dose-escalation study of GS-0321, formerly COM503, continues as planned. GS-0321 is an anti-IL-18 binding protein antibody licensed to Gilead. Ophir said the study includes monotherapy and PD-1 combination dose escalation, as well as monotherapy backfill cohorts.
Compugen has received $90 million from Gilead related to the asset and remains eligible for up to $758 million in additional milestone payments, plus single-digit to low-double-digit tiered royalties.
- Cash, cash equivalents, short-term bank deposits and marketable securities totaled approximately $125.3 million as of June 30, 2026.
- Second-quarter revenue was approximately $2.6 million, compared with $1.3 million a year earlier, reflecting recognition of portions of Gilead upfront and IND milestone payments.
- Research and development expense was approximately $6.3 million, up from $5.6 million in the prior-year period.
- General and administrative expense was approximately $2.3 million, compared with $2.2 million a year earlier.
- Net loss was approximately $7 million, or $0.07 per basic and diluted share, versus a loss of approximately $7.3 million, or $0.08 per share, in the second quarter of 2025.
Chief Financial Officer David Silberman said the company expects its cash runway, assuming no further cash inflows, to support operating plans into 2029, including MAIA-ovarian, GS-0321 clinical progress and investment 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.
