Compugen (CGEN) Q2 FY26 earnings call: guidance and Q&A

What is known about the patient population in the cited trials that led to the revised 4-month PFS assumption for the MAIA-ovarian placebo arm, and what is the confidence level in this new estimate?

The two European trials (Dova, OREO) included more heavily pretreated patients with liver metastases, resulting in a 2.8-month median PFS. The 4-month estimate for MAIA-ovarian's placebo arm is an adjustment between historical data (5.5 months) and these new findings. Management emphasizes the internal randomized control arm will provide definitive comparison.

“So due to this, these patients were actually more heavily pretreated than our MAIA-ovarian trial. And their placebo control arm had a median PFS of 2.8 months. We anticipate that the actual benchmark is somewhere in between the historical data sets, which we took from the original registration trials for the PARP inhibitors, which was approximately 5.5 months and these new updated trials who have a similar patient population. And therefore, we've adjusted it to approximately 4 months.”

asked by Stephen Willey · answered by Michelle Mahler

Has Gilead discussed presenting dose escalation data for GS-0321, and is the trial currently dose escalating in combination with a PD-1 inhibitor and monotherapy?

Due to pharma confidentiality, specific details cannot be disclosed. However, it was confirmed that dose escalation is occurring in both monotherapy and combination with PD-1, with backfill cohorts and an expansion phase. It is considered early for data reporting, 18 months into a Phase I study.

“I would just remind that as you -- this said, we have dose escalation in mono and in combination with PD-1. We also have backfill cores in the monotherapy, meaning more patients in the higher doses, and then, the expansion phase. So we're looking at benchmark studies in this stage. Yes, I think it's reasonable to assume that everything is moving forward as planned.”

asked by Stephen Willey · answered by Michelle Mahler

Could the MAIA-ovarian data readout occur before year-end, and are there specific biomarkers being evaluated alongside clinical PFS?

The guidance for the readout remains by Q1 2027, despite the adjusted placebo PFS estimate. The primary readout is progression-free survival, and there is no specific biomarker selection strategy other than patient characteristics (e.g., excluding liver metastases). An exploratory biomarker analysis plan will be executed once data is unblinded.

“So we're -- our primary readout is progression-free survival. We don't get -- we don't have a specific biomarker selection strategy other than patient characteristics where we have excluded patients with liver metastases. And the other thing to note is that in our earlier data, we did see activity in patients who were both PD-L1 positive and PD-L1 negative.”

asked by Milan Gersha · answered by Michelle Mahler

Have there been interactions with the FDA regarding the MAIA-ovarian trial supporting an expedited or accelerated approval path?

No meeting with the FDA has occurred yet. However, the trial design incorporates FDA guidelines, including those from Project Frontrunner. The company is confident that robust data will enable productive engagement with the FDA regarding potential approval paths.

“So at this point in time, we have not had a meeting with the FDA. Once the trial reads out, we will follow all the appropriate regulatory steps. What I will say to you is we incorporated a lot of the guidelines from the FDA in designing the trial, and it's definitely in line with their guidance on project frontrunner, which is 1 of the reasons why we did go into an earlier line of treatment as well as using the trial design, which is, again, part of the FDA guardlines that have recently come out.”

asked by Swayampakula Ramakanth · answered by Michelle Mahler

With 12 Phase III studies for rilvegostamig, when can the earliest readout be expected, and does the new trial impact outstanding milestones?

The new Phase III trial does not change the milestone terms. AstraZeneca's formal guidance for Phase III results is after 2027, meaning 2028, although earlier analyses are possible. AstraZeneca continues to report Phase II data at conferences.

“So we could refer only to what AstraZeneca was saying. And while they are reporting continuously data on Phase II studies in ASCO and in the conferences, the Phase III results according to their guidance is after '27, meaning '28. It doesn't mean that it couldn't be earlier to analysis and other options, but the actual formal guidelines are after '27 for the Phase III studies.”

asked by Swayampakula Ramakanth · answered by Eran Ophir