Compugen’s 2026 Q2 Earnings Call: Shifting PFS Benchmarks, Delayed Trial Timelines, and Uncertain FDA Path Spark Contradictions

Date of Call: Aug 3, 2026

Financials Results

• Revenue: $2.6M, compared to $1.3M in the comparable period in 2025
• EPS: $0.07 loss per basic and diluted share, compared to $0.08 loss per basic and diluted share in the second quarter of 2025

Guidance:

• Cash runway expected to fund operating plans into 2029.
• MAIA-ovarian interim analysis with median progression-free survival data anticipated by Q1 2027.
• Continued advancement of COM701 in platinum-sensitive ovarian cancer trial and progression of GS-0321 in the clinic.

Business Commentary:

Clinical Trial Progress and Interim Analysis:

• Compugen's MAIA-ovarian trial for COM701 is progressing and is on track for an interim analysis by Q1 2027.
• The trial is evaluating COM701 as a maintenance monotherapy in patients with relapsed platinum-sensitive ovarian cancer, a setting with significant unmet medical need.

Adjustment of Control Arm Assumption:

• Based on recent clinical trials, the estimated median progression-free survival for the placebo control group in the MAIA trial was adjusted to approximately four months.
• This adjustment reflects the more heavily pretreated patient populations in the referenced trials, which had shorter progression-free survival durations.

Financial Stability and Cash Runway:

• As of June 30, 2026, Compugen had approximately $125.3 million in cash equivalents, short-term bank deposits, and investments in marketable securities.
• The company's cash runway, assuming no further cash inflows, is expected to fund operating plans into 2029, providing financial flexibility to advance clinical trials and invest in the pipeline.

Partnership and Collaborative Efforts:

• Compugen's collaboration with AstraZeneca on rilvegostomig continues to advance, with AstraZeneca initiating a new phase III trial in urothelial carcinoma.
• The partnership with Gilead on GS-0321 (formerly COM503) is progressing as planned, with the potential for significant milestone and royalty payments.

Sentiment Analysis:

Overall Tone: Positive

• CEO stated 'Q2 was a quarter of steady advancement, I’m pleased with the progress we have made across every part of the company.' Also noted 'We are encouraged by the additional rilve data... which we believe continues to support the differentiated profile of this bispecific and its potential as an immune oncology backbone.'

Q&A:

• Question from Stephen Willey (Stephens): I was just curious, it sounds like you’ve taken down your control arm assumption in the MAIA trial by maybe about a month and a half. What do you know about the patient population from these two trials that you cited with respect to things like liver metastasis status and I guess just general patient eligibility criteria? I would just be curious to get a better understanding as to your level of confidence now around this revised four-month number.
  Response: The two European trials had more heavily pretreated patients than MAIA-ovarian, including liver metastases and multiple prior treatments, leading to a shorter placebo control PFS of ~2.8 months. The adjusted assumption of ~4 months is between this and historical PARP inhibitor trial data; the actual trial data will be critical.

• Question from Stephen Willey (Stephens): Maybe just quickly on GS-0321. I guess you’ve been dose escalating now for, I guess, around 18 months or so. Have you had a conversation with Gilead about presenting some of the dose escalation data before you move into dose expansion? Is it safe to assume that you are now dose escalating both in combination with the PD-1 inhibitor and I guess monotherapy as well?
  Response: Dose escalation is proceeding in both monotherapy and combination with PD-1, including a backfill course in monotherapy. It is reasonable to assume the study is moving forward as planned, but specific data disclosure timing is not yet determined.

• Question from Leland Gershell (Oppenheimer): Just wondering with respect to the MAIA-ovarian trial, the guidance for the data. Just wondering, given the nature of the changing assumptions and event-driven nature, could you see, to the extent possible, a readout that might come before the end of the year? Also want to ask, are there any particular biomarkers that you’ll be looking at alongside the clinical PFS out-
  Response: The Q1 2027 timeline for the interim analysis is maintained; the readout depends on data maturity. The primary readout is progression-free survival; no specific biomarker selection strategy is used, but exploratory analysis will be conducted post-unblinding.

• Question from RK (H.C. Wainwright): Have you had any interactions with the FDA to see if the MAIA-ovarian trial alone could support either an expedited or an accelerated path for approval, especially in this setting that we don’t really have a drug approved?
  Response: No FDA meeting has been held; regulatory steps will follow post-trial readout. The trial design incorporates FDA guidelines (e.g., Project FrontRunner, Bayesian design), providing confidence for future engagements.

• Question from RK (H.C. Wainwright): On the partnership with AstraZeneca, now that they have 12 clinical studies going on and 12 phase III studies going on, do you have an idea of what we should expect in terms of the earliest phase III readout that we could see? Also, this inclusion of the new trial, does it change either the schedule or composition of the $95 million in a milestone outstanding?
  Response: The new phase III trial in urothelial carcinoma does not change the agreement terms; it is an additional opportunity. AstraZeneca's formal phase III readouts are guided to be after 2027 (2028), though earlier interim data could be possible.

Contradiction Point 1

Assumed Control Arm PFS in MAIA-ovarian Trial

Inconsistent benchmark for placebo control arm progression-free survival (PFS).

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2026Q2: The current assumption for MAIA-ovarian placebo control is approximately four months, adjusted between the historical PARP inhibitor trial data (~5.5 months) and these newer, more heavily pretreated trials. - Dr. Michelle Mahler(CMO)

What is your confidence level in the revised four-month control arm assumption for the MAIA trial, considering the patient population details such as liver metastasis status and eligibility criteria from the two trials you cited? - Swayampakula Ramakanth (H.C. Wainwright & Co, LLC)

2026Q1: The trial is exploratory; the control arm benchmark PFS is ~5.5 months (range 3.8-5.8 months). A 3-month improvement over this benchmark would be considered meaningful single-agent activity for COM701. - Michelle Mahler(CMO)

Contradiction Point 2

Potential for MAIA-ovarian Trial Design Adjustments

Contradiction on whether interim data could lead to trial design changes.

Leland Gershell (Oppenheimer) - Leland Gershell (Oppenheimer)

2026Q2: The Q1 2027 timeline for the interim analysis is maintained; the readout depends on actual data maturity and will be reported when ready. - Dr. Eran Ophir(CEO)

With respect to the MAIA-ovarian trial, could you provide an update on the potential timeline for readout, including any possibility before the end of the year, and discuss the biomarkers that will be evaluated alongside clinical PFS in future studies? - Leland Gershell (Oppenheimer & Co. Inc.)

2026Q1: Interim data in Q1 2027 could lead to design adjustments (e.g., adding arms), depending on data totality and regulatory discussions. - Michelle Mahler(CMO) and Eran Ophir(CEO)

Contradiction Point 3

MAIA-Ovarian Trial Interim Analysis Timeline

The anticipated timeline for the MAIA trial readout has shifted from H2 2026 to Q1 2027.

Leland Gershell (Oppenheimer) - Leland Gershell (Oppenheimer)

2026Q2: The Q1 2027 timeline for the interim analysis is maintained. - Dr. Eran Ophir(CEO)

Given the changing assumptions and event-driven nature of the MAIA-ovarian trial, could a readout occur before year-end, and what biomarkers will be evaluated alongside clinical PFS in future studies? - Swayampakula Ramakanth (H.C. Wainwright & Co, LLC)

2025Q4: The shift to a Q1 2027 readout was due to a slower-than-expected opening of major U.S. academic sites. - Eran Ophir(CEO)

Contradiction Point 4

FDA Regulatory Path Discussion for MAIA-Ovarian

Contradiction on whether discussions with the FDA regarding an expedited approval path have taken place.

What are RK's earnings call highlights as covered by H.C. Wainwright? - RK (H.C. Wainwright)

2026Q2: No FDA meeting has been held regarding regulatory path yet. - Dr. Michelle Mahler(CMO)

Have you discussed with the FDA whether the MAIA-ovarian trial could support expedited or accelerated approval, given the lack of approved drugs in this setting? - Rabib Chaudhury (Leerink Partners LLC)

2025Q4: The timeline and requirements for registration will depend on the totality of the data. A positive monotherapy signal could open a path for combination strategies... - Michelle Mahler(CMO), Eran Ophir(CEO)

Contradiction Point 5

Confidence in Placebo Control Arm PFS Estimate

Inconsistent portrayal of the certainty behind the key trial assumption.

Stephen Willey (Stephens) - Stephen Willey (Stephens)

2026Q2: The current assumption for MAIA-ovarian placebo control is approximately four months, adjusted between the historical PARP inhibitor trial data (~5.5 months) and these newer, more heavily pretreated trials. The actual placebo control PFS will be determined by the blinded trial data. - Dr. Michelle Mahler(CMO)

What do you know about the patient population from the two trials cited regarding liver metastasis status and general eligibility criteria? - Leland Gershell (Oppenheimer & Co. Inc.)

2025Q3: Demonstrating single-agent activity with an improvement of up to 3 months in progression-free survival (PFS) above placebo would be clinically meaningful. The totality of the data will guide next steps... - Dr. Eran Ophir(CEO) and Dr. Michelle Mahler(CMO)