Compugen Q4 2025 Earnings Call - AstraZeneca Monetization Buys Runway into 2029 While Preserving Majority Royalties

Operator: Ladies and gentlemen, thank you for joining us today. Welcome to Compugen’s fourth quarter and full year 2025 results conference call. At this time, all participants are in listen-only mode. An audio webcast of this call is available in the investor section of Compugen’s website, www.cgen.com. As a reminder, today’s call is being recorded. With us from the Compugen team are Dr. Eran Ophir, President and CEO, and David Silberman, Chief Financial Officer. Dr. Michelle Mahler, Chief Medical Officer, will join for the Q&A.

Before we begin, we would like to remind you that during this call, the company may make projections or forward-looking statements regarding future events, business outlook, development efforts and their potential outcome, the company’s discovery platform, anticipated progress and plans, results and timelines for our programs, including disclosure of clinical data, financial and accounting related matters, as well as statements regarding our cash position and cash runway. We wish to caution you that such statements reflect only the company’s current beliefs, expectations and assumptions. Actual results, performance or achievements of the company may differ materially. These statements are subject to known and unknown risks and uncertainties. We refer to you our SEC filings for more details on these risks, including the company’s most recent annual report on Form 20-F. The company undertakes no obligation to update projections and forward-looking statements in the future.

With that, I now turn the call over to Eran.

Dr. Eran Ophir, President and CEO, Compugen: Thank you, operator. Welcome to everyone joining our call today. In 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 COM-902, 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 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 COM-701 and our potential first-in-class anti-IL-18 binding protein antibody GS-0321 licensed to Gilead. We also advanced our clinical footprints, opening sites in the U.S., Israel and France in our COM-701 clinical trial. In addition, we presented clinical updates at ESMO and SITC conferences for COM-701 and GS-0321 respectively. 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 million in upfront non-dilutive capital from AstraZeneca, extend their expected cash runway into 2029. It provides an additional $25 million at the next milestone payment, which is BLA acceptance, thereby increases our total remaining milestones to up to $195 million from $170 million previously. We retain the majority of our royalty interest, leaving our economics fundamentally intact. Both before and after the deal, we remain eligible for up to mid-single-digit tiered royalties from rilvegostomig sales. We believe this deal allowed us to unlock value today to continue advancing our innovative immune oncology pipeline, including COM-701, GS-0321, and our early-stage pipeline, it allows us to reach both internal and partners catalysts.

All of this without compromising our long-term upside in rilvegostomig, a potentially multi-billion-dollar asset. To put this into context, rilvegostomig is being advanced by AstraZeneca in a broad late-stage development program, including 10 active phase 3 trials. AstraZeneca previously estimated a non-risk adjusted peak annual revenue potential of more than $5 billion for rilvegostomig. Next, let me briefly touch on the leadership transition. I’m 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 next phase of growth. Turning now to clinical execution, starting with COM-701.

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 in Israel. I also want to highlight the data represented at ESMO last year from the COM-701 pooled analysis of phase 1 clinical data in platinum-resistant ovarian cancer. The pooled analysis demonstrated that COM-701 was well-tolerated and showed consistent durable responses in patients with heavily pre-treated platinum-resistant ovarian cancer, particularly in those without liver metastasis, representing patients with lower disease burden and potentially less immunosuppressive tumor macroenvironment. We believe this data support the rationale for advancing COM-701 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 1 dose escalation and expansion trial and subsequently presented the trial in progress update at SITC. Overall, we believe that our achievements in 2025 set the stage for continued execution in 2026. transitions me nicely to our 2026 strategic priorities, which includes the continued execution of the MAIA-ovarian adaptive trial. The first subtrial is a randomized trial comparing COM-701 monotherapy to placebo in the maintenance settings of platinum-sensitive ovarian cancer, a setting where there is a significant unmet medical needs 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 for a potential backbone for drug combination in this population.

We’re also enabling potential broader clinical development plan across ovarian cancer lines of treatments and in other indications where clinical signals were seen for COM-701. In parallel, we’re executing on our phase I trial with GS-0321. Where 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’s new and a cool mechanism, and based on preclinical data, this approach may offer advantages on both safety and efficacy. Gilead has already paid $60 million upfront and an additional $30 million when it successfully achieved IND clearance.

We’re eligible to receive up to additional $758 million in future milestones and single-digit to low double-digit tiered royalties. The ongoing phase 1 constitutes 2 parts. Part 1, dose escalation, and Part 2, dose expansion. In addition, we continue to track our partner AstraZeneca’s progress very closely as they execute on their broad phase 3 rilvegostomig program. Given the recent history in the TIGIT field, it’s 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. Let me explain. On format, rilvegostomig is an anti-PD-1/TIGIT bispecific antibody that has a 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 ADC combinations when tested in ex vivo patients 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. To summarize, our confidence in REALVI is based on its differentiation at different drug formats 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. Unigen is the AI machine learning-based computational engine that generated COM-701, COM-902, and GS-0321. We remain committed to investing in this differentiated discovery platform. Stepping back, let me summarize where we are today. We have a unique positioning, solid financial outlook that enable us to continue and leverage our computational drug target discovery engine to deliver the next generation of novel immune oncology assets. We have a clinical pipeline grounded in potential first-in-class immune oncology science. We have two validating partnerships with AstraZeneca and Gilead, representing approximately up to $1 billion 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 for your dedication. With that, let me turn it over to David for the financial update before we open the call for questions.

David Silberman, Chief Financial Officer, Compugen: Thanks, Eran. I am pleased to say that we are advancing in 2026 with a solid balance sheet. Cash runway, assuming no further cash inflows, is expected to fund our operating plans into 2029. We anticipate using this runway as planned to advance our COM-701 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 December 31st, 2025, we had approximately $145.6 million in cash equivalents, short-term bank deposits and investments in marketable securities.

The cash balance at the end of 2025 included the $65 million upfront payment from AstraZeneca for the monetization of a small portion of rilvegostomig future royal deals. On the revenues front, we reported approximately $67.3 million in revenues for the fourth quarter of 2025 and approximately $72.8 million for the year ended December 31st, 2025, compared to approximately $1.5 million and $27.9 million in revenues for each of the comparable periods in 2024. Revenues for 2025 include the upfront payment of $65 million 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 the portion of the upfront payment and the IND milestone payment from the license agreement with Gilead and the $5 million clinical milestone payment from AstraZeneca. Moving to expenses. R&D expenses for the fourth quarter of 2025 and for the year ended December 31, 2025 were approximately $5.5 million and $22.8 million, respectively, compared with approximately $5.9 million and $24.8 million 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 GN expenses for the fourth quarter of 2025 and for the year ended December 31, 2025, were approximately $2.1 million and $8.9 million, respectively, compared with approximately $2.2 million and $9.4 million for the comparable periods in 2024. Finally, on net profit. For the fourth quarter of 2025, we reported a net profit of approximately $56.8 million or approximately $0.60 per basic and diluted share, compared to a net loss of approximately $6.1 million or approximately $0.07 per basic and diluted share in the comparable period of 2024.

Net profit for the year ended December 31, 2025, was approximately $35.3 million or approximately $0.38 per basic and diluted share, compared with a net loss of approximately $14.2 million 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, at this time we will begin the question and answer session. If you have a question, please press star one. If you wish to decline from the polling process, please press star two. If you are using speaker equipment, kindly leave the handset before pressing the numbers. Please stand by while we poll for your questions. The first question is from Daina Graybosch of Leerink Partners. Please go ahead.

Roni Tamari, Analyst, Leerink Partners: Hi, this is Roni Tamari on for Daina Graybosch. First question I would have is, can you help us level set on what to expect in the 1Q 2027 update with COM-701 in terms of what we expect to see in that update? 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.

David Silberman, Chief Financial Officer, Compugen: Michelle, do you want to take it?

Dr. Michelle Mahler, Chief Medical Officer, Compugen: Sure. I’m happy to take it. Thanks for the question. The current trial is an adaptive trial design, we anticipate that there will be data maturation in 1Q of 2027. Regarding the timeline and what will be required for registration, it’s gonna 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’re still in discussion and not at this point in time ready to disclose.

David Silberman, Chief Financial Officer, Compugen: Yeah. I think we can say high level, as we said in the past, that there are a few opportunities here. I mean, one is to continue if the data indeed is, has meaningful clinical, clinically, it can continue to fast forward the monotherapy. It can open a path for combination strategies in that population. Of course, because we know the trial signal also in pro and under education, a positive monotherapy signal in this trial also open many other options. I guess the, our first steps will be in that specific population following the positive results.

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

Josh Nickerson / Leland Gerschel, Analyst, Stifel / Oppenheimer: Hey, team. This is Josh on for Steve. Could you just remind us the cadence of potential outlying milestones for rilvegostomig, and maybe just provide some color on the next trigger for milestone payment upcoming? Thank you.

Dr. Eran Ophir, President and CEO, Compugen: David, do you want to take it?

David Silberman, Chief Financial Officer, Compugen: 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 million on top of what we’re already entitled to. Going forward, we’ll still be entitled to $195 million in milestone from AstraZeneca on the rilvegostomig deal.

Operator: We’re having some technical issues. Just a moment, please. Eran, can you hear us?

Dr. Eran Ophir, President and CEO, Compugen: Absolutely.

Operator: Okay. Maybe, the speaker just disconnected. We’ll move to the next question. Next question is from Swayampakula Ramakanth of H.C. Wainwright. Please go ahead.

Swayampakula Ramakanth (RK), Analyst, H.C. Wainwright: Thank you. This is RK from H.C. Wainwright. Good morning, Eran. trying to think through the ovarian trial, you know, previously you had stated you will have some the interim analysis done in the second half of 2026. Now it’s moved to the first quarter of 2027. I’m just trying to understand the shift. Is it, is it, is it more because you’re adding additional centers, or is it because, you know, you see a slower accumulation of events, than what you initially modeled for?

Dr. Eran Ophir, President and CEO, Compugen: Yeah. Thanks, RK. We reported that shift already in the previous quarter, and the reason back then was a bit slower. By the way, it was not only Compugen issue, but again, for us it was a bit slower opening of the major academic U.S. sites, which we’re very glad that now all of them are open. Actually, now all the sites are open. All 28 sites are open. We mitigate for that. We are gladly we were approached by the ARCAGY-GINECO group, which are actually have experience in very, 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, like in any trial, we need to see that the events are accumulating as expected. Other than that, everything is on track, and we continue to be in Q1 2027 as we report also in the last quarter. No change in this quarter for that.

Swayampakula Ramakanth (RK), Analyst, H.C. Wainwright: Okay. Thanks for that. Then in terms of the AstraZeneca relationship, obviously the 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 COM-902 derived TIGIT in additional multi-specific formats, you know, within the AstraZeneca portfolio?

Dr. Eran Ophir, President and CEO, Compugen: AstraZeneca are controlling rilvegostomig. We don’t discuss with them their own plans. I mean, we did see recently they, and this is again, I think, illustrating the commitment for the program. We did see recently a new phase 3 trial now in gastric in combination with CLDN AT point 2 ADC, which is now in ClinicalTrials.gov. This would be, when it’s activated, the 11th phase 3 trial. They are expanding rilvegostomig. It’s not specifically COM-902, but rilvegostomig, which contains COM-902. For COM-902 specifically, we fully own it, and obviously it’s a different opportunity that we can leverage in other collaborations. Probably AstraZeneca, with the rilvegostomig, they will move with that one and not this COM-902.

Swayampakula Ramakanth (RK), Analyst, H.C. Wainwright: The last question from me is on the GS-0321. You know, you, in terms of the data that’s expected, you know, would that be in any of the medical conferences, or where would we see that data? Will we see more than just initial safety?

Dr. Eran Ophir, President and CEO, Compugen: you know. The first patient was dosed at the beginning of 2025. By our agreement with Gilead, obviously when we report data, it has to be fully aligned with them. For now, we don’t 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. For now we are not making any commitments because it will need to be in alignment with Gilead.

Swayampakula Ramakanth (RK), Analyst, H.C. Wainwright: Thank you. Thanks for taking all my questions.

Dr. Eran Ophir, President and CEO, Compugen: Thank you, RK.

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

Josh Nickerson / Leland Gerschel, Analyst, Stifel / Oppenheimer: Hey, good morning, and thanks for taking our question. Eran, just wondering as we await the update on COM-701 in, you know, about a year from now, first quarter of 2027, just wanted to ask what you may plan to be presenting at the various oncology meetings this year, you know, ESMO, SITC, and so forth. Can you give us a flavor of what we might see out of Compugen through 2026? Thank you.

Dr. Eran Ophir, President and CEO, Compugen: Overall, from what we currently disclose, and obviously along the year we might update it. From what we currently disclose, we, for the, Gilead, as just mentioned, we don’t have any specific guidelines, but it could be along medical conference along the year. AstraZeneca’s, and again, it’s AstraZeneca program and AstraZeneca decision, but they do have some clinical readouts this year, and they might report it in some of the scientific conference. They didn’t disclose yet when. This is basically what we disclosed for this year, and obviously next year will be the MAIA-ovarian study readout, which is an important one.

Josh Nickerson / Leland Gerschel, Analyst, Stifel / Oppenheimer: Great. Thank you.