Compugen Ltd. (CGEN) Q4 FY2025 Earnings Call Transcript & Summary

Ladies and gentlemen, thank you for joining us today. Welcome to Compugen's Fourth Quarter and Full Year 2025 Results Conference Call. [Operator Instructions] An audio webcast of this call is available in the Investors 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 results and time lines 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, 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.

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 nondilutive transaction with AstraZeneca tied to Rilve, 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 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 Rilve royalties to AstraZeneca. This deal is important today and for the long term because it added $65 million in upfront nondilutive capital from AstraZeneca, extend 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 royalty 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 Rilve 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 Rilve, a potentially multibillion-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 III 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 we had 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 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 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 these 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 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 the continued execution of the MAIA-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 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 for a potential backbone for drug combination in this population, while also enabling potential broader clinical development plan across ovarian cancer lines of treatments and in other indications where clinical signals were seen for COM701. 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 we 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 I 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 III Rilve 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. So let me explain. On format, Rilve 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 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. 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 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. So 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 2 validating partnerships with AstraZeneca and Gilead, representing approximately up to $1 billion in potential milestones plus royalties. And 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 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, 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 31, 2025, we had approximately $145.6 million in cash, 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 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 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 G&A 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 Instructions] The first question is from Daina Graybosch of Leerink Partners.

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? And then the follow-up to that is, can you help us understand the time line and what is required for that path to registration that you mentioned in the call?

Michelle, do you want to take it?

Sure. I'm happy to take it. Thanks for the question. So the current trial is an adaptive trial design, and we anticipate that there will be data maturation in 1Q of 2027. And regarding the time line 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 discussion. Not at this point in time, ready to disclose.

Yes. 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 -- clinically continue to path for the [indiscernible] monotherapy, it can open a path for combination strategies in that population. And of course, because we know that [indiscernible] and other indication, a positive monotherapy signal in this trial also open many other options. But I guess our first steps will be in that specific population following a positive readout.

The next question is from Josh Nickerson of Stifel.

This is Josh on for Stifel. 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.

David, do you want to take it?

Yes, sure. Josh, thank you for the question. Yes, 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're already entitled to. So going forward, we will still be entitled to $195 million in milestone from AstraZeneca, the rilvegostomig deal.

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

Absolutely.

So maybe speakers just disconnected. We'll move to the next question. The next question is from Swayampakula Ramakanth of H.C. Wainwright.

This is RK from H.C. Wainwright. So trying to think through the ovarian trial. Previously, you had stated that you will have some -- the interim analysis done in the second half of '26. 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?

Yes. 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 was not only Compugen issue, but again, for us, it was a bit slower opening of the major academical 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 AstraZeneca group, which actually have experience 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 '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 we continue to be in Q1 '27 as we report also in the last quarter. So no change in this quarter for that.

Okay. 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 COM902-derived TIGIT in additional multi-specific formats within the AstraZeneca portfolio?

So AstraZeneca controlling rilvegostomig, we don't discuss with them their own plans. I mean we did see recently that -- and this is again, 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 ClinicalTrial.gov. So this would be when it's activated the 11th Phase III trial. So 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 you can leverage in other collaborations, probably AstraZeneca with rilvegostomig, they will move with that one and not with COM902.

And then the last question for 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? And will we see more than just initial safety?

So we initiated 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. But for now, we are not making any commitment because it will need to be in alignment with Gilead.

The next question is from Leland Gershell of Oppenheimer.

Eran, just wondering as we await the update on 701 in about a year from now, first quarter of '27, I 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?

So 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 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 MAIA study readout, which is an important one.

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