Compugen Ltd.

Thank you for joining us today. Welcome to CompuGent's fourth quarter and full year 2025 Revolve Council's call. At this time, all participants are in listen-only mode. An audio webcast of this call is available in the investor section of CompuGent's website, www.cgen.com. As a reminder, today's call is being recorded. With us from the CompuGent team are Dr. Erana Fil, 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 program, including disclosure of clinical data, financial and accounting-related matters, as well as statements regarding our cash position and cash runways. We wish to caution you that such statements reflect only the company's current beliefs, expectations, and assumptions, but actual results, performance, or achievements of the company may differ materially. These statements are subject to known and unknown risks and uncertainties, and we refer to you our SEC filing for more details on these risks, including the company's most recent annual report on Form 28. 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.

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 runaway into 2029, assuming no further cash inflows, through a non-dilutive transaction with AstraZeneca. Sites are relevant. They're differentiated, PD1-tigit by specific, the digit 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 I transitioned to executive chair. On the clinical side, we advance our clinical programs, initiate new clinical trials with our fully-owned potential first-in-class anti-fever GCOM701 and our potential first-in-class anti-AL18 binding protein antibody GS0321, licensed to Gilead. We also advance our clinical footprints, opening sites in the U.S., Israel, and France in our GCOM701 clinical trial. We presented clinical updates at ESMO and CC conferences for COM701 and GS0321, 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 real-world 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, extended our expected cash runway into 2029. It provides an additional $25 million at the next milestone payment, which is BLA acceptance, and thereby increases our total remaining milestones to up to $195 million from $170 million previously. And we retained the majority of our relative interest. levering our economics fundamentally intact. So both before and after the deal, we remain eligible for up to mid-single-digit tiered royalties from real vessels. We believe this deal allowed us to unlock value today, to continue advancing our innovative immune oncology pipeline, including COM701, GS0321, and our early-stage pipeline, and it allows us to reach both internal and partner catalysts. All of this without compromising our long-term upside in Rilve, a potentially multi-billion dollar asset. And to put this into context, Rilve 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 Rilve. 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 he has a leadership structure that combines operational focus and strategic continuity, a strong foundation for COMPOGEN's next phase of growth. Turning now to clinical execution. starting with COM701. In the Mayo Ovarian Clinical Trial, in the platinum-sensitive ovarian cancer, we initiated dosing and expanded our trial footprint globally by opening trial sites in the US, France, and in Israel. I also want to highlight the data we presented at ESMO last year from the COM701 pooled analysis of phase one clinical data in platinum-resistant ovarian cancer. The pooled analysis demonstrated that COM7-1 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 supports the rationale for advancing COM7-1 in the early-reliance settings as maintenance therapy in platinum-sensitive ovarian cancer. These programs underscore our commitment to pioneering innovative biology. Regarding GS0321, our parted program with Gilead, we initiated dosing in a phase one dose escalation and expansion trial, and subsequently presented a trial in progress update at CITI. 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 includes the continued execution of the Maya Ovarian Adaptive Trial. The first sub-trial is a randomized trial comparing Comstevoran monotherapy to placebo in the maintenance settings 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 past registration and for a potential backbone for drug combination in this population. We're also enabling potential broader clinical development plan across ovarian cancer line of treatment and in other indications where clinical signals were seen for COM701. In parallel, we're executing on our phase one trial with GS0321. As a reminder, the first patient was those in January 2025. GS0321 is our potential first in class anti-IL-18 binding protein antibody licensed to Gilead. We believe that the key differentiator of GS0321 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 will offer advantages on both safety and efficacy. Gillette 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 one constitutes two parts. Part one, load escalation, and part two, In addition, we continue to track our partner, AstraZeneca's progress very closely as they execute on their broad phase three RILVE program. Given the recent history in the fidget 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. So let me explain. On formats, RILVE is an anti-PD1 TGIT bispecific antibody that has a reduced FC functionality. This design delivers coordinated inhibition of both PD1 and TGIT on the same immune effector cells with cooperative binding resulting in greater efficacy than anti-PD1 plus anti-TGIT single adi combinations when tested in ex vivo patients derived models of non-small cell lung cancer. In addition, this form of 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' digit trials, and also include novel combinations like ADCs that have not been tested thus far. So to summarize, our confidence in RILVE is based on its differentiation, a different drug format, and a different clinical trial and combination strategy. Lastly, turning to our early-stage pipeline, with our current cache 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 COM701, COM902, and GS0321, and we remain committed to investing in this differentiated discovery platform. So, stepping back, let me summarize where we are today. We have a unique positioning, solid financial outlook, that enables 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, that's Rosenica and Gilead. representing approximately up to $1 billion in potential milestones plus . And 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.

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, and we anticipate using this runway as planned to advance our COM701 platinum-sensitive ovarian cancer trial, Maya Ovarian, and to support the progression of GS0321 in the clinic, together with continued investment in our early-stage pipelines. 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 investment in marketable securities. The cash balance at the end of 2025 included the $65 million up from payment from AstraZeneca for the monetization of a small portion of River Gosling's future royalties. 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 31, 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 a 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 31st, 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 Mayo variant trial initiated in 2025. Our G&E 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 profits. 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 cents per basic and diluted share, compared with a net loss of approximately $14.2 million, or approximately 16 cents 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.

Thank you. Ladies and gentlemen, at this time, we will begin to question and answer sessions. If you have a question, please press star 1. If you wish to decline from the polling process, please press star 2. If you are using speaker equipment, kindly lift the handset before pressing the numbers. Please stand by while we pull for your questions. The first question is from Diana Grayburt of Learning Partners. Please go ahead.

Hi, this is Rabib on for Dana. First question I would have is can you help us level set on what to expect in the 1Q27 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.

Michelle, do you want to take it?

Sure. I'm happy to take it. Thanks for the question. The current trial is an adaptive trial line, and we anticipate that there will be data maturation in 1Q of 2027. And regarding the timeline and what will be required for registration is going to really depend on the totality of the data. And we are planning for success and would have to consider other subsequent plans or trials, which we are still in discussion with. not at this point in time ready to disclose.

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 has meaningful clinical, if you can continue to pass for depression and 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 under education, a positive monotherapy signal in this trial also open many other options. But I guess our first steps would be in that specific population following a positive result.

The next question is from Josh Nickerson of Stiffer. Please go ahead.

Could you just remind us the cadence of potential outlying milestones for Robogostomeg and maybe just provide some color on the next trigger for milestone payment upcoming? Thank you.

David, do you want to take it?

Yeah, sure. Hi, Joe. Thank you for the question. Yeah, as a reminder, so we did the deal with AstraZeneca in December. And we disclosed our next milestone will be BLA acceptance, on which we will be entitled to an additional $25 million, on top of what we were already entitled to. So going forward, we will still be entitled to $195 million in milestone from AstraZeneca on the river cost to make deal.

We're having some technical issues. Just a moment, please. Can you hear us?

Absolutely.

Okay, so maybe the speaker just disconnected. We'll move to the next question. The next question is from . Please go ahead.

Thank you. This is from . Good morning. So trying to think through the ovarian trial, you know, previously you had stated you will have the interim analysis done in the second half of 26. to the first quarter of 27. Just trying to understand the shift. 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?

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's 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're glad that we were approached by the group which actually have experience in that specific patient population, and they approached us to contribute to the study, so gladly they joined as well. Now we have all the sites open, fully on track to have the readout in Q127. Obviously, like in any trial, we need to see that the events are accumulating as expected, But other than that, everything is on track and it will continue to be in Q127 as we report also in the last quarter. So no change in this quarter for that.

Okay. Thanks for that. And 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 con902-derived TGET in an additional multi-specific format, you know, within the AstraZeneca portfolio?

So, AstraZeneca controlling Gylbergostomy, we don't discuss with them their own plans. I mean, we did see recently, and this is again, I think, illustrating the commitment for the program. We did see recently a new phase three trial now in gastric in combination with 18.2 ADC, which is now in clinicaltrial.gov. So this would be when it's activated, the 11th phase three trial. So they are expanding . It's not specifically COM902, but which contains COM902. For COM902 specifically, we fully own it, and obviously it's a different opportunity that you can leverage in other collaborations, probably AstraZeneca And with the , they will move with that one and not with COM902.

And then the last question for me is on the 0321. You know, 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 and will we see more than just initial safety?

So, you know, we initiated the first patient with dogs at the beginning of 25. 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. But for now, we are not making any commitments because it will need to be in alignment with Gilead.

Thank you. Thanks for taking all my questions.

Thank you, Arkadiy.

The next question is from Leland Gershel of Oppenheimer. Please go ahead.

Hi, good morning. Thanks for taking our question. I'm just wondering as we await the update on 701 in June, about a year from now, first quarter of 27, just wanted to ask what you may plan to be presenting at the various oncology meetings this year, you know, ESMO, CITC, and so forth. Can you give us a flavor of what we might see out of Compugen through 26? Thank you.

Overall, from what we currently disclose, and obviously along the year we might update it, from what we currently disclose, For the just mentioned, we don't have any specific guidelines, but it could go along medical conference along the year. AstraZeneca, 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. And this is basically what we disclosed for this year, and obviously next year will be the Maya study readout, which is an important one.

Great. Thank you.

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