Compugen (CGEN) Q4 2025 Earnings Call Transcript

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Date

Monday, March 2, 2026 at 8:30 a.m. ET

Call participants

• Chief Executive Officer — Eran Ophir
• Executive Chair — Anat Cohen-Dayag
• Chief Financial Officer — David Silberman
• Chief Development Officer — Michelle Mahler

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Takeaways

• Cash position -- $145.6 million in cash, cash equivalents, short-term bank deposits, and marketable securities as of Dec. 31, 2025, which includes a $65 million upfront payment from AstraZeneca (NASDAQ:AZN).
• Cash runway extension -- Expected cash runway extended into 2029, assuming no further cash inflows, supported by the non-dilutive AstraZeneca transaction.
• Q4 revenue -- $67.3 million reported for the quarter ended Dec. 31, 2025, compared to $1.5 million in Q4 2024; increase driven primarily by AstraZeneca and Gilead (NASDAQ:GILD) payments.
• Full-year revenue -- $72.8 million for 2025, up from $27.9 million in 2024, reflecting new royalty monetization and milestone receipts.
• R&D expenses -- $5.5 million in Q4 and $22.8 million for 2025, down from $5.9 million and $24.8 million in the prior-year periods, primarily due to winding down earlier trials and increased expenses for the new MAIA trial.
• G&A expenses -- $2.1 million in Q4 and $8.9 million for the full year, slightly below 2024 levels ($2.2 million for Q4 and $9.4 million for the year).
• Q4 net profit -- $56.8 million, or $0.60 per basic and diluted share, reversing a loss of $6.1 million ($0.07 per share) reported in Q4 2024.
• Annual net profit (2025) -- $35.3 million, or $0.38 per basic and diluted share, versus a net loss of $14.2 million ($0.16 per share) in 2024.
• AstraZeneca royalty monetization -- December 2025 transaction monetized a portion of future rilvegostomig royalties, adding $65 million upfront and entitling Compugen Ltd. (NASDAQ:CGEN) to $25 million upon BLA acceptance. Aggregate remaining potential milestones from the partnership increased to $195 million, with Compugen Ltd. retaining eligibility for mid-single-digit tiered royalties.
• Gilead milestones -- Gilead paid €60 million upfront and $30 million for IND clearance related to GS-0321, with up to $758 million in future milestones and royalty potential.
• COM701 clinical development -- The MAIA ovarian trial for platinum-sensitive ovarian cancer initiated dosing and opened 28 clinical sites in the U.S., France, and Israel, with interim analysis expected in the first quarter of 2027.
• GS-0321 development activities -- Patient dosing initiated in the Phase I trial in January 2025; trial design encompasses both dose escalation and dose expansion phases.
• Strategic leadership changes -- Eran Ophir became CEO in September 2025, with Anat Cohen-Dayag transitioning to Executive Chair to enhance operational focus and strategic continuity.
• Early-stage pipeline investment -- Continued focus on early-stage immuno-oncology, managed by the largest internal team, and ongoing investment in the Unicigen computational drug discovery platform.
• Rilvegostomig clinical activity -- AstraZeneca advancing rilvegostomig in 10 active Phase III trials, with a new eleventh trial in gastric cancer combining with a claudin 18.2 ADC to be activated.
• MAIA trial population note -- Pooled analysis for COM701 highlighted consistent, durable responses and favorable tolerability in heavily pretreated platinum-resistant ovarian cancer, especially without liver metastasis.
• Conference milestones -- Clinical updates for COM701 presented at ESMO and trial-in-progress updates for GS-0321 presented at SITC; further data disclosures will occur in alignment with respective partners.
• Partnered program upside -- Compugen Ltd. positions its AstraZeneca and Gilead partnerships as representing up to $1 billion in aggregate milestones plus tiered royalties.

Summary

Compugen Ltd. (NASDAQ:CGEN) reported a major financial inflection, transforming a previous annual net loss into a net profit on significant non-dilutive inflows from AstraZeneca and Gilead. Management emphasized having extended its operating runway into 2029, providing strategic flexibility for continued pipeline development without additional funding. Leadership changes were completed with Eran Ophir assuming the CEO role, contributing to perceived operational stability. The MAIA trial for platinum-sensitive ovarian cancer reached the intended clinical site activation, and interim efficacy data are expected in the first quarter of 2027, while GS-0321 trials progress under Gilead’s partnership. AstraZeneca’s commitment to rilvegostomig is evidenced by the initiation of additional Phase III studies, potentially expanding future milestones and royalty flows for Compugen Ltd..

• Gilead’s upfront and IND milestone payments, together with future milestone eligibility for GS-0321, provide diversified, multi-year external funding sources.
• Partner statements repeatedly cited eligibility for new milestone tranches at BLA acceptance and beyond, reinforcing future cash inflow expectations tied to regulatory progress.
• Eran Ophir said, "All 28 sites are open," emphasizing resolution of prior site activation delays in the MAIA trial, which could de-risk near-term clinical timelines compared to previous quarters.

Industry glossary

• Rilvegostomig: A bispecific antibody targeting PD-1 and TIGIT, developed by AstraZeneca with a component sourced from Compugen Ltd.’s COM902 antibody.
• BLA (Biologics License Application): The regulatory submission to the FDA for permission to market a biologic product.
• MAIA trial: Compugen Ltd.'s adaptive, global clinical trial investigating COM701 in platinum-sensitive ovarian cancer.
• PROC: Platinum-resistant ovarian cancer, a highly challenging, relapsed ovarian cancer population.
• Unicigen: Compugen Ltd.’s artificial intelligence and machine learning–driven computational drug discovery platform.
• ADC (Antibody–Drug Conjugate): A targeted therapy that links a monoclonal antibody to a potent cytotoxic drug, allowing targeted delivery to cancer cells.
• IND (Investigational New Drug): An application to the FDA seeking approval to begin clinical trials of a new drug in humans.

Full Conference Call Transcript

Eran Ophir: Thank you, operator. And welcome to everyone joining our call today. On today's call, I would like to highlight some of our key achievements in 2025 and outline our planned strategic priorities for 2026. During 2025, we made progress across our business—scientifically, operationally, and financially—including the following key highlights: we extended our expected cash runway into 2029, assuming no further cash inflows, through a non-dilutive transaction with AstraZeneca tied to rilvegostomig, their differentiated PD-1/TIGIT bispecific, the TIGIT component of which is derived from COM902, our fully owned Fc-reduced anti-TIGIT antibody. We also diversified our leadership team as I stepped into the CEO role in September 2025, and Anat Cohen-Dayag transitioned to Executive Chair.

On the clinical side, we advanced our clinical programs, initiating new clinical trials with our wholly owned potential first-in-class anti-PVRIG COM701 and our potential first-in-class anti–IL-18 binding protein antibody GS-0321, licensed to Gilead. We also advanced our clinical footprint, opening sites in the U.S., Israel, and France in our COM701 clinical trial. In addition, we presented clinical updates at ESMO and SITC conferences for COM701 and GS-0321, respectively. So let me elaborate on each of these highlights, starting with the most recent update—our December 2025 strategic transaction with our partner AstraZeneca, where we monetized a small portion of our future rilvegostomig royalties to AstraZeneca.

This deal is important today and for the long term because it added $65,000,000 in upfront non-dilutive capital from AstraZeneca to extend our expected cash runway into 2029. It provides an additional $25,000,000 at the next milestone payment, which is BLA acceptance, and thereby increases our total remaining milestones to up to $195,000,000 from $170,000,000 previously, and we retained the majority of our royalty interest, leaving our economics fundamentally intact. So both before and after the deal, we remain eligible for up to mid-single-digit tiered royalties from rilvegostomig.

We believe this deal allowed us to unlock value today, continue advancing our innovative immuno-oncology pipeline including COM701, GS-0321, and our early-stage pipeline, and it allows us to reach both internal and partnered catalysts, all of this without compromising our long-term upside in rilvegostomig, a potentially multibillion-dollar asset. And to put this into context, rilvegostomig is being advanced by AstraZeneca in a broad late-stage development program, including 10 active Phase III trials. AstraZeneca previously estimated a non-risk-adjusted peak annual revenue potential of more than $5,000,000,000 for rilvegostomig. Next, let me briefly touch on the leadership transition. I am excited and privileged to have had the opportunity to step into the role of President and CEO in September 2025.

With Anat now serving as Executive Chair, we believe we have a leadership structure that combines operational focus and strategic continuity, a strong foundation for Compugen Ltd.'s next phase of growth. Turning now to clinical execution, starting with COM701. In the MAIA ovarian clinical trial in platinum-sensitive ovarian cancer, we initiated dosing and expanded our trial footprint globally by opening trial sites in the U.S., France, and Israel. I also want to highlight the data we presented at ESMO last year from the COM701 pooled analysis of Phase I clinical data in platinum-resistant ovarian cancer.

The pooled analysis demonstrated that COM701 was well tolerated and showed consistent durable responses in patients with heavily pretreated platinum-resistant ovarian cancer, particularly in those without liver metastasis, representing patients with lower disease burden and potentially less immunosuppressive tumor microenvironment. We believe this data supports the rationale for advancing COM701 in the earlier-line settings as maintenance therapy in platinum-sensitive ovarian cancer. These programs underscore our commitment to pioneering innovative biology. Regarding GS-0321, our partnered program with Gilead, we initiated dosing in a Phase I dose-escalation and expansion trial and subsequently presented a trial-in-progress update at SITC.

Overall, we believe that our achievements in 2025 set the stage for continued execution in 2026, which transitions me nicely to our 2026 strategic priorities, which include continued execution of the MAIA ovarian adaptive trial. The first sub-trial is a randomized trial comparing COM701 monotherapy to placebo in the maintenance setting of platinum-sensitive ovarian cancer, a setting where there is a significant unmet medical need and no current standard of care. We are on track to have an interim analysis in Q1 2027. This data could lead to maintenance monotherapy path-to-registration and form a potential backbone for drug combinations in this population.

We are also enabling a potential broader clinical development plan across ovarian cancer lines of treatment and in other indications where clinical signals were seen for COM701. In parallel, we are executing on our Phase I trial with GS-0321. As a reminder, the first patient was dosed in January 2025. GS-0321 is our potential first-in-class anti–IL-18 binding protein antibody licensed to Gilead. We believe that the key differentiator of GS-0321 is that it is not a cytokine, but an antibody harnessing cytokine biology for the treatment of cancer. It is a new and unique mechanism, and based on preclinical data, this approach may offer advantages on both safety and efficacy.

Gilead has already paid €60,000,000 upfront and an additional $30,000,000 when we successfully achieved IND clearance. We are eligible to receive up to an additional $758,000,000 in future milestones and single-digit to low double-digit tiered royalties. The ongoing Phase I constitutes two parts: part one, dose escalation, and part two, dose expansion. In addition, we continue to track our partner AstraZeneca's progress very closely as they execute on their broad Phase III rilvegostomig program. Given the recent history in the TIGIT field, it is worth taking a moment to explain why we maintain confidence. For us, the answer is clear: antibody format matters, and clinical and combination strategy matters. So let me explain.

On formats, rilvegostomig is an anti–PD-1/TIGIT bispecific antibody that has reduced Fc functionality. This design delivers coordinated inhibition of both PD-1 and TIGIT on the same immune effector cells, with cooperative binding resulting in greater efficacy than anti–PD-1 plus anti-TIGIT single-agent combination when tested in ex vivo patient-derived models of non-small cell lung cancer. In addition, this format, using reduced Fc functionality, may reduce the unwanted depletion of immune effector cells and maintain a favorable safety profile. On clinical strategy, AstraZeneca's trials are designed differently from some other companies' TIGIT trials and also include novel combinations like ADCs that have not been tested thus far.

So to summarize, our confidence in rilvegostomig is based on its differentiation as a different drug format and a different clinical trial and combination strategy. Lastly, turning to our early-stage pipeline. With our current cash runway expected into 2029, 2026 will be a year of continued focus on our early-stage pipeline, which is managed by the largest team within Compugen Ltd. Unicigen is the AI/machine-learning-based computational engine that generated COM701, COM902, and GS-0321, and we remain committed to investing in this differentiated discovery platform. Before stepping back, let me summarize where we are today.

We have a unique positioning and solid financial outlook that enable us to continue and leverage our computational drug target discovery engine to deliver the next generation of novel immuno-oncology assets. We have a clinical pipeline grounded in potential first-in-class immuno-oncology science, and we have two validating partnerships—AstraZeneca and Gilead—representing approximately up to $1,000,000,000 in potential milestones plus royalties. Our team is consistently striving to deliver at the highest levels. I am incredibly proud of what our team has delivered and equally excited about the opportunities ahead. Thank you to everyone at Compugen Ltd. for your dedication. I will now turn the call over to David for the financial update before we open the call for questions.

Operator: Thanks, Eran.

David Silberman: I am pleased to say that we are advancing in 2026 with a solid balance sheet and cash runway, assuming no further cash inflows, expected to fund our operating plans into 2029, and we anticipate using this runway as planned to advance our COM701 platinum-sensitive ovarian cancer trial, MAIA ovarian, and to support the progression of GS-0321 in the clinic, together with continued investment in our early-stage pipeline. Going into the details, I will start with our cash balance. As of 12/31/2025, we had approximately $145,600,000 in cash, cash equivalents, short-term bank deposits, and marketable securities. The cash balance at year-end 2025 included the $65,000,000 upfront payment from AstraZeneca for the monetization of a small portion of rilvegostomig future royalties.

On the revenues front, we reported approximately $67,300,000 in revenues for the quarter ended 12/31/2025, and approximately $72,800,000 for the year ended 12/31/2025, compared to approximately $1,500,000 and $27,900,000 in revenues for each of the comparable periods in 2024. Revenues for 2025 include the upfront payment of $65,000,000 from AstraZeneca and a portion of the upfront payment and the IND milestone payment from the license agreement with Gilead, while the revenues for 2024 reflect a portion of the upfront payment and the IND milestone payment from the license agreement with Gilead and the $5,000,000 clinical milestone payment from AstraZeneca.

Moving to expenses, R&D expenses for the quarter ended 12/31/2025 and for the year ended 12/31/2025 were approximately $5,500,000 and $22,800,000, respectively, compared with approximately $5,900,000 and $24,800,000 for the comparable periods in 2024. The decrease in 2025 was mainly due to lower clinical expenses resulting from winding down prior clinical trials, partially offset by an increase in clinical expenses related to the MAIA ovarian trial initiated in 2025. Our G&A expenses for the quarter ended 12/31/2025 and for the year ended 12/31/2025 were approximately $2,100,000 and $8,900,000, respectively, compared with approximately $2,200,000 and $9,400,000 for the comparable periods in 2024.

Finally, on net profit, for the quarter ended 12/31/2025, we reported a net profit of approximately $56,800,000, or approximately $0.60 per basic and diluted share, compared to a net loss of approximately $6,100,000, or approximately $0.07 per basic and diluted share in the comparable period of 2024. Net profit for the year ended 12/31/2025 was approximately $35,300,000, or approximately $0.38 per basic and diluted share, compared with a net loss of approximately $14,200,000, or approximately $0.16 per basic and diluted share in the comparable period of 2024. With that, I will hand over to the operator to open the call for questions.

Operator: Thank you. Ladies and gentlemen, we will now open for questions. If you wish to decline from the polling process, please press the appropriate key. If you are using speaker equipment, kindly lift the handset before pressing the numbers. The first question is from Daina Graybosch of Ernek Partners. Please go ahead.

Rabeeb (for Daina Graybosch, Ernek Partners): Hi. This is Rabeeb on for Daina. First question I would have is, can you help us level-set on what to expect in the Q1 2027 update with COM701 in terms of what we expect to see in that update? And then the follow-up to that is, can you help us understand the timeline and what is required for that path to registration that you mentioned in the call? Thank you.

Eran Ophir: Michelle, do you want to take it?

Michelle Mahler: Sure. I am happy to take it. Thanks for the question. So the current trial is an adaptive trial design, and we expect that there will be data maturation in 2027, and regarding the timeline and what will be required for registration, it is going to really depend on the totality of the data. We are planning for success and would have to consider other subsequent plans or trials, which we are still in discussion on and not at this point in time ready to disclose.

Eran Ophir: Yes, I think we can say at a high level, as we said in the past, that there are a few opportunities here. One is to continue if the data indeed is meaningful clinically. That can continue the path for the treatment as monotherapy. It can open a path for combination strategies in that population, and of course, because we know the trial signal also in PROC and other indications, a positive monotherapy signal in this trial also opens many other options. But I guess our first steps would be in that specific population following a positive readout.

Operator: The next question is from Josh Nicholson of Stifel. Please go ahead.

Josh Nicholson (for Steve, Stifel): Hey, team. This is Josh on for Steve. Could you just remind us of the cadence of potential outlying milestones for rilvegostomig and maybe just provide some color on the next trigger for a milestone payment upcoming? Thank you. David, do you want to take it?

David Silberman: Yes, sure. Hi, Josh. Thank you for the question. As a reminder, we did the deal with AstraZeneca in December. We disclosed that our next milestone will be BLA acceptance, on which we will be entitled to an additional $25,000,000 on top of what we are already entitled to. So going forward, we will still be entitled to $195,000,000 in milestones from AstraZeneca under the rilvegostomig deal.

Operator: We are having some technical issues. Just a moment, please. Hello? Can you hear us?

Eran Ophir: Absolutely.

Operator: Okay. So maybe the speakers just disconnected. We will move to the next question. The next question is from Swayampakula Ramakantha of HC Wainwright. Please go ahead.

Swayampakula Ramakantha (HC Wainwright): Thank you. This is RK from HC Wainwright. Good morning, Eran. So I am trying to think through the ovarian trial. Previously you had stated you will have some interim analysis done in 2026. Now it has moved to 2027. I am just trying to understand the shift. Is it because you are adding additional centers, or is it because you see a slower accumulation of events than what you initially modeled for?

Eran Ophir: Yeah. Thanks, RK. So we reported that shift already in the previous quarter, and the reason back then was a bit slower—by the way, it is not only a Compugen Ltd. issue—but again, for us, it was a bit slower opening of the major academic U.S. sites, which we are very glad that now all of them are open. Actually, now all the sites are open—all 28 sites are open. We mitigated for that. Gladly, we were approached by the Akaji Giniko group, which actually has experience in that specific patient population, and they approached us to contribute to the study. So gladly, they joined as well.

We now have all the sites open, fully on track to have the readout in Q1 2027. Obviously, in any trial, we need to see that the events are accumulating as expected. Other than that, everything is on track, and the readout will continue to be in Q1 2027, as we reported also in the last quarter. So no change in this quarter for that.

Swayampakula Ramakantha (HC Wainwright): Okay. And then in terms of the AstraZeneca relationship, obviously, recent monetization speaks to the alignment, to the deep alignment, that AstraZeneca wants to have with the drug. Are there any discussions of expanding the use of the COM902-derived TIGIT in an additional multispecific format within the AstraZeneca portfolio?

Eran Ophir: So AstraZeneca controls rilvegostomig. We do not discuss with them their own plans. I mean, we did see recently—and this is, I think, illustrating the commitment for the program—we did see recently a new Phase III trial now in gastric in combination with claudin 18.2 ADC, which is now in clinicaltrials.gov. So this would be, when it is activated, the eleventh Phase III trial. So they are expanding with rilvegostomig. It is not specifically COM902, but rilvegostomig, which contains COM902. For COM902 specifically, we fully own it, and, obviously, it is a different opportunity that we can leverage in other collaborations. Probably AstraZeneca, with rilvegostomig, will move that one and not specifically COM902.

Swayampakula Ramakantha (HC Wainwright): And then the last question from me is on the 0321. In terms of the data that is expected, would that be in any of the medical conferences? Or where would we see that data? And will we see more than just initial safety?

Eran Ophir: So we initiated—the first patient was dosed in 2025. By our agreement with Gilead, obviously, when we report data, it has to be fully aligned with them. For now, we do not have guidelines, but typically—and also, I think what Gilead will do themselves—is to report it in a scientific conference, and typically it will include activity plus safety. But for now, we are not making any commitment because it will need to be in alignment with Gilead. Thank you.

Operator: The next question is from Leland Gershell of Oppenheimer. Please go ahead.

Leland Gershell (Oppenheimer): Hey, good morning. Thanks for taking our question. I am just wondering, as we await the update on 701 in about a year from now, 2027, just wanted to ask what you may plan to be presenting at the various oncology meetings this year—ESMO, SITC, and so forth. Can you give us a flavor of what we might see out of Compugen Ltd. through 2026? Thank you.

Eran Ophir: Overall, from what we currently disclosed—and obviously, during the year, we might update it—from what we currently disclose, for the Gilead program, as I have just mentioned, we do not have any specific guidelines, but it could go along medical conferences along the year. AstraZeneca—and again, it is AstraZeneca's program and AstraZeneca's decision—but they do have some clinical readouts this year, and they might report them in some of the scientific conferences. They did not disclose yet when. And this is basically what we disclosed for this year. And, obviously, next year would be the MAIA study, which is an important one. Great. Thank you.

Operator: This concludes the Q&A session and Compugen Ltd.'s investor call. Thank you for your participation. You may go ahead and disconnect.

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