Compugen Ltd.

Compugen Ltd.

627.50
ILA
-25.10
(-3.85%)
110.54EPS
5.79P/E
60.69BMarket Cap
Nov 16Next Earn

Q4 FY2025 · Earnings Call TranscriptMarch 2, 2026

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 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 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.

Eran Ophir

Thank you, operator, and 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 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 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 footprints, opening sites in the US, 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.

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, extending 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. We retained the majority of our royalty interests, 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 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. 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's next phase of growth.

Turning now to clinical execution, starting with COM701. In the MAYA ovarian clinical trial in 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 1 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 support 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 1 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: the continued execution of the MAYA ovarian adaptive trial.

The first sub-trial is a randomized trial comparing COM701 monotherapy to placebo in the maintenance settings of platinum-sensitive ovarian cancer, a settings 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 for a potential backbone for drug combination in this population. We are also enabling 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're executing on our Phase 1 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 a 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 are 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 two 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 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-antibody combinations 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. To summarize, our confidence in rilvegostomig 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 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 COM701, COM902, and GS-0321, and 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 immuno-oncology assets. We have a clinical pipeline grounded in potential first-in-class immuno-oncology science, and 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'm incredibly proud of what our team has delivered and equally excited about the opportunities ahead.

Thank you to everyone at Compugen for dedication. With that, let me turn it over to David for the financial update before we open the call for questions.

David Silberman

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 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, cash equivalents, short-term bank deposits, and investment 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 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 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 a portion of the upfront payment and the IND milestone payment from the license agreement with Gilead and a $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 MAYA ovarian trial initiated in 2025. Our G&A expenses for the fourth quarter of 2025 and for the year ended December 31st, 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 60 cents per basic and diluted share, compared to a net loss of approximately $6.1 million, or approximately 7 cents per basic and diluted share, in the comparable period of 2024.

Net profit for the year ended December 31st, 2025, was approximately $35.3 million, or approximately 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.

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 lift the handset before pressing the numbers. Please stand by while we pool for your questions.

The first question is from Diana Graybosch of Leerink Partners. Please go ahead.

Rabib Chaudhury

Hi, this is Rabib on for Daina. First question I would have is: can you help us level set on what to expect in the 1Q '27 update with COM701 in terms of what we expect to see in that update?

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'm happy to take it. Thanks for the question.

The current trial is an adaptive trial design, and we anticipate that there will be data maturation in 1Q of 2027. Regarding the timeline and what will be required for registration, it's 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 discussions in, not at this point in time ready to disclose.

Eran Ophir

I think we can say high level, as we've said in the past, that there are a few opportunities here. One is you can continue to fast forward the trial as monotherapy.

It can open a path for combination strategies in that population. Of course, because we know that we had signal also in PROC and other indications, a positive monotherapy signal in this trial also open many other options.

I guess our first steps would be in that specific population following a positive readout.

Operator

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

Joshua Nickerson

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 a milestone payment upcoming?

Thank you.

Eran Ophir

David, do you want to take it?

David Silberman

Sure. Hi, Josh.

Thank you for the question. As a reminder, we did the deal with AstraZeneca in December, and we disclosed our next milestone would 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 will still be entitled to $195 million in milestones from AstraZeneca on the rilvegostomig deal.

Operator

We're having some technical issues, just a moment, please. Eran, can you hear us?

Eran Ophir

Absolutely.

Operator

Maybe the speaker just disconnected. We'll move to the next question.

The next question is from Swayampakula Ramakanth of H.C. Wainwright.

Please go ahead.

Swayampakula Ramakanth

Thank you. This is RK from H.C.

Wainwright. Good morning, Eran.

Trying to think through the ovarian trial, previously, you had stated you will have the interim analysis done in the second half of '26, and now it's moved to the first quarter of '27. I'm just trying to understand the shift.

Is it more because you're adding additional centers, or is it because you see a slower accumulation of events than what you initially modeled for?

Eran Ophir

Thanks, RK. Sure, 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 academical US 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, gladly we were approached by the Arcagy GINECO group, which are actually have experience in that specific patient population, and they approached us to contribute to the study, gladly they joined as well.

Now have all the sites open, fully on track to have the readout in Q1 '27. 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 continue to be in Q1 '27, as we reported also in the last quarter.

No change this quarter for that.

Swayampakula Ramakanth

Thanks for that. Then in terms of the AstraZeneca relationship, obviously, the recent monetization speaks 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 additional multispecific formats within the AstraZeneca portfolio?

Eran Ophir

AstraZeneca controlling rilvegostomig, we don't discuss with them their own plans. 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 claudin 18.2 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 COM902, but rilvegostomig which contains COM902.

For COM902 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 with COM902.

Then

Swayampakula Ramakanth

the last question from me is on the 0321. In terms of the data that's expected, would that be in any of the medical conferences, or where would we see that data?

Will we see more than just initial safety?

Eran Ophir

The first patient was dosed 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. For now, we are not making any commitments because it will need to be in alignment with Gilead.

Swayampakula Ramakanth

Thank you. Thanks for taking all my questions.

Eran Ophir

Thank you, RK.

Operator

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

Leland Gerschel

Hey, good morning and thanks for taking our question. Eran, just wondering, as we await the update on 701 in about a year from now, first quarter of '27, just want 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 through '26? Thank you.

Eran Ophir

Overall, from what we currently disclose, and obviously along the year we might update this, for the Gilead, as just mentioned, we don't have any specific guidelines, but it could be along medical conferences along the year. AstraZeneca, then 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 conferences.

They didn't disclose yet when. This is basically what we disclose for this year, and obviously next year will be the MAYA study readout, which is an important one.

Leland Gerschel

Great, thank you.