Q3 2025 Compugen Ltd Earnings Call

Speaker #1: Ladies and gentlemen, thank you for joining us today. Welcome to the COMPUGEN third quarter 2025 results conference call. At this time, all participants are in a listen-only mode.

Speaker #1: 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. I would now like to introduce Yvonne Naughton, VP, Head of Investor Relations and Corporate Communications.

Speaker #1: Yvonne, please go ahead.

Speaker #2: Thank you, Operator, and thanks everyone for joining us today. Here with me from COMPUGEN team are Erano Fehr, our new President and CEO, and David Silberman, our Chief Financial Officer.

Speaker #2: Michelle Mahler, our Chief Medical Officer, will join us for the Q&A. Before we begin, we would like to remind you that during this call, the company may make projections of forward-looking statements regarding future events.

Speaker #2: Business outlook, development efforts, and the potential outcome. The company's discovery platform, anticipated progress and plans, results, and timelines for our programs, including disclosures of clinical data, financial and accounting-related matters, as well as statements regarding our cash position and cash runway.

Speaker #2: 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.

Speaker #2: These statements are subject to known and unknown risks and uncertainties, and we refer you to our SEC filing for more details on these risks, including the company's most recent annual report and Form 20F.

Speaker #2: The company undertakes no obligation to update projections and forward-looking statements in the future. With that, I'll turn the call over to Eran.

Speaker #3: Thanks, Yvonne. Good morning and good afternoon, everyone. I'm delighted to speak with you today as COMPUGEN's new President and CEO. I'm really energized stepping into this role as such pivotal time for our company.

Speaker #3: Having led our scientific strategy, in my former position as CSO, I've seen firsthand how our science has evolved, and I believe we can deliver significant value for patients.

Speaker #3: So where do we stand today? Our fundamentals are strong, and our strategy is clear. We are pioneers in computational drug target discovery, and we believe that our deep expertise in digital biology is now gaining clinical momentum.

Speaker #3: I think that now is a great time to highlight what makes us different in the digital drug development space and why you should be paying close attention to our differentiated FC-reduced anti-digit programs and their advantages over FC-active anti-digit antibodies.

Speaker #3: Reflecting on the history of drug development, one can appreciate that indeed choosing the right therapeutic target to cure disease is critically important, but choosing the right drug format which fits that specific target is just as important.

Speaker #3: We know that anti-digit antibodies with the FC-active format have not lived up to expectations, and most of these programs were discontinued. However, this did not surprise us because FC-active anti-digits can deplete digit-positive effector T cells and Tregs. This is not desired because, one, on efficacy, digit is present on effector T cells, so similar to the action of anti-PD-1s, you want to reinvigorate these exhausted cells and avoid their depletion.

Speaker #3: Two, on safety, digit is present on T regs, depleting peripheral T regs could result in immune-mediated side effects. FC-reduced anti-digits like our own common NO2, in contrast, preserve and reinvigorate effector T cells, avoid depletion of peripheral T regs, and therefore have the potential for improved immune activation and a better safety profile.

Speaker #3: It is notable that as early as Phase Two trials, with FC-active anti-digits, safety was a concern, with high rates of discontinuation due to adverse events.

Speaker #3: This was also even more evident in the phase three trials, for example, during recent ESMO meeting, the presenter highlighted that in SCRISE KRAPER 07 trial, adding FC-active digit to a TISO resulted in these patients only receiving median number of doses of 12 versus 17 in the TISO-only arm.

Speaker #3: As a result, the patients receiving digit PD-L1 combination received 30% less the PD-L1 antibody versus control. So safety really impacted the ability to administer treatment and therefore probably impacted the outcome.

Speaker #3: We've always advocated for the FC-reduced formats and we believe that the data starting to support our conviction. Not all anti-digit antibodies are the same.

Speaker #3: And we believe the market is missing this. We believe our assets are positioned to capture the upside, as new data emerges, with read-out anticipated from 2026.

Speaker #3: Provided our conviction proved correct. This moves us to our strategy, which is rooted in science and focused on patients. We have five key value drivers.

Speaker #3: Starting on FC-reduced digit programs, common NO2 is one of the only two clinical-stage FC-reduced anti-digit monoclonal antibodies currently in clinical development. Importantly, it's fully owned by COMPUGEN.

Speaker #3: Positive phase three data from Arcus Gilead with the only other known FC-reduced anti-digit monoclonal antibody is expected in 2026 and could be a real catalyst for common NO2.

Speaker #3: Notably, recent overall survival data from their Phase 2 frontline gastric cancer study, which is in the same setting as the Arcus-Gilead ongoing Phase 3 trial, was presented at ESMO recently and showed a median overall survival of 27 months versus 15 months or less for benchmarks.

Speaker #3: A meaningful signal for the FC-reduced class. Next is rivarugostamib, our partner AstraZeneca's FC-reduced anti-PD-1 digit bispecific, with the digit component derived from our FC-reduced high affinity common NO2.

Speaker #3: Interestingly, cooperative bispecific binding might provide even further efficacy into PD-1 and digit blockade, while in addition, potentially supporting an easier regulatory path. The potential commercial opportunity for real-based substantial with AstraZeneca estimating non-risk adjusted peak ERI revenue target of more than 5 billion.

Speaker #3: We understand that AstraZeneca's ambition is for real to replace PD-1, PD-L1 therapies and to service the backbone for future combination treatments. Their broad development program spanning 11 phase three trials across lung, gastrointestinal, and endometrial cancers represent a potential significant value drive for COMPUGEN as we're eligible for regulatory and commercial milestones and meet single digit tiered royalties payments.

Speaker #3: Moving to FC-reduced PVRIG, COM701. Fully owned and the only FC-reduced monoclonal anti-PVRIG antibody in the clinic, which, again, we believe is the right FC format.

Speaker #3: The biology here is truly differentiated from PD-1 and digit checkpoints, providing advantages that we believe could translate into clinical benefit for patients with platinum sensitive ovarian cancer.

Speaker #3: Positive data in our ongoing myoovarian platform trial could support a broader clinical development program aimed at addressing a significant unmet medical need. And finally, to our cool and smart potential first-in-class antibody program addressing cytokine biology.

Speaker #3: GS0321, previously COM503, is a potential first-in-class anti-iodine binding protein antibody, licensed to Gilead. GS0321 represents a novel antibody approach to harness iodine passed by biology for the treatment of cancer, potentially overcoming the limitations presented by administration of therapeutic cytokines.

Speaker #3: It represents another potential value driver for COMPUGEN as we're eligible to receive $758 million in milestone payments and single-digit to low double-digit tiered royalties.

Speaker #3: This program is the most recent example of how our AI ML power discovery engine is delivering new opportunities. And behind this, we have early pipeline of what we believe to be truly innovative research programs.

Speaker #3: As pioneers in the field, we're committed to delivering real breakthroughs, not just incremental therapies. And real innovation is never easy. It takes time, persistence, and willingness to tackle the toughest scientific challenges.

Speaker #3: But I believe deeply in what we are doing here, and we have the best talent and great tools to do this. I am truly excited about the potential of our early-stage programs.

Speaker #3: Next, turning to the progress we have made this quarter. The team was at ESMO in Berlin in October, where we presented the pooled analysis of our three previously reported Phase 1 trials reflecting the clinical benefit of COM701 as monotherapy and in combination in patients with heavily pretreated platinum-resistant ovarian cancer.

Speaker #3: The pooled analysis demonstrated that COM701 was well tolerated, 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 a potentially less immunosuppressive tumor microenvironment.

Speaker #3: The results of the analysis support the rationale for the ongoing randomized myoovarian platform trial evaluating COM701 as maintenance therapy in early lines of treatment.

Speaker #3: The myoovarian platform trial is progressing sites have been activated across the US, Israel, and France including major academical centers and multiple sites from the French oncology cooperative group Arcagi Gyneco, renowned for several recent platinum sensitive ovarian cancer trials.

Speaker #3: We now estimate the interim analysis in Q1 2027. We believe myoovarian is a significant opportunity to address an unmet need for maintenance therapy in platinum sensitive ovarian cancer.

Speaker #3: Next, our partner AstraZeneca which presented new relevant data at ESMO as part of two mini oral sessions. Out of my 01 follow-up showed that relevant was well tolerated with promising efficacy confirming its potential in checkpoint naive non-small cell lung cancer.

Speaker #3: Notably, the drug-related discontinuation rate of only 3% further support differentiation of the FC-reduced formats. The troponin pan-tumor O3 evaluating combinational relevant with data way showed promising efficacy and manageable safety underscoring the potential of next generation IO bispecific plus ADC.

Speaker #3: Moving next to Gero S0321, our novel antibody approach with Gilead that leverages cytokine biology the phase run trial is progressing as planned and represented last trial design at CC last week.

Speaker #3: We have strong conviction in our fully owned programs where validating partnerships with AstraZeneca and Gilead providing potential for over 1 billion in milestone plus royalties.

Speaker #3: Of course, none of this would be possible without our highly committed, talented team here at COMPUGEN who continuously performs at the highest level of excellence.

Speaker #3: With that, I will hand over to David for the financial update before we open the floor for Q&A.

Speaker #2: Thanks, Aron. I am pleased to say that we are advancing in 2025 with a solid balance sheet. Cash runway assuming no further cash inflows is expected to fund our operating plans into the third quarter of 2027, and we anticipate using this runway to advance our COM701 platinum sensitive ovarian cancer trial myoovarian and to support the progression of GS0321 in the clinic together with continued investment in our early stage pipeline.

Speaker #2: Going into the details, I will start with our cash balance. As of September 30th, 2025, we had approximately 86 million dollars in cash, cash equivalents, short-term bank deposits, and investment in marketable securities.

Speaker #2: In October 2025, subsequent to the financial results for the quarter ended September 30th, 2025, a total of approximately 0.8 million shares were sold through the company's ATM facility contributing to a net proceeds of approximately 1.6 million dollars.

Speaker #2: Revenues for the third quarter of 2025 were approximately 1.9 million dollars compared to approximately 17.1 million dollars of revenue for the comparable period in 2024.

Speaker #2: The revenues for the third quarters of 2025 and 2024 reflect the recognition of respective portions of both the upfront payment and the IND milestone payment from the license agreement with Gilead.

Speaker #2: Expenses for the third quarter of 2025 were in line with our plans. R&D expenses for the third quarter of 2025 were approximately $5.8 million compared to approximately $6.3 million in the third quarter of 2024.

Speaker #2: Our G&A expenses for the third quarter of 2025 were approximately 2.2 million dollars and approximately 2.6 million dollars for the same period in 2024.

Speaker #2: For the third quarter of 2025, our net loss was approximately 6.98 million dollars or 7 cents per basic and diluted share compared to a net profit of approximately 1.28 million dollars or 1 cent per basic and diluted share in the third quarter of 2024.

Speaker #2: With that, I will hand over to the operator to open the call for questions.

Speaker #3: Thank you. Ladies and gentlemen, at this time we will begin to question and answer session. If you have a question, please press star one.

Speaker #3: 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.

Speaker #3: Please stand by while we pull for your questions. The first question is from Stefan Wiley of Stifel. Please go ahead.

Speaker #4: Yeah, good morning. Thanks for taking the question. I was just curious to the extension of the MAIA in terminalysis from, I guess, the second half of 26 into the first quarter of 27.

Speaker #4: Is that just predicated on enrollment timelines and kind of what you're seeing just from an accrual perspective? Does that have anything to do with the accumulation of PFS events in the study that may be required to trigger the interim?

Speaker #4: Just curious as to what's kind of happening behind the scenes there. Thanks.

Thank you. It's a very good question. So this will be the first phase 3 readout for NFC reduced digital. Antibody the data. Look promising. But it was a single, our study, not many patients, but doubling almost doubling. The, the overall survival versus torque on control was reassuring. And now is the time to see how it evolves in the phase 3. And this is, of course, could be very meaningful for us.

And but it is only 1 trial. So obviously um if it's successful, this reflects directly on the F to reduce and what what we're saying about, the FC active, the safety issues, potential reduced, efficacy issues, and and this will show directly the deficit reduced our active insight to your results. But

even if this trial fails Arcus, gilad himself had additional Faith to Faith, retries additional 2 ones and

Aro has 2 additional advantages over the just a single monoclonal F reduced 1. Is they show that the revised specific has a potential more activity and actually show that in a very nice xvivo patient, direct material system and they have a Cooperative binding that allow um um Cooperative blockade of p p pd1 and digit on the same cell and the result was in that relatively translational system that it's more active than just P1 and P2 block.

and then,

Also, in some of the trials, the other potential regulatory Advantage is the way we will see it and looking just for the side of all the accumulating phase rituals for example, in run of the trials in the I believe the automate biller is 013 River.

Plus chemo. So just

and because it's by specific. Nobody can ask for a contribution of components as far as we understand it and therefore, you don't need to show that digit is active. Yes, you believe digit is active and they have to reduce, but even if the activity is not sufficient, in this case, having both enhanced efficacy due to the by specific formats and just using it as a IO, safe backbone to combine with chemo to compare with the skimo. This is definitely an advantage of device specific. They have some other trials doing the same.

And also have some trials, doing directly head-to-head versus pembro and we believe and think that they should have a window as well. But so they have multiple shots on goal with some advantages of the by specific indeed.

The next question is from.

The next question is from Leland of Oppenheimer. Let's go ahead.

Oh hey, good morning. Uh, thanks for the update. Um, and taking our question just wondering, um,

If you, as we look forward to the interim update from Myovant, could you remind us of any internal threshold or bar you're looking for from that intern, with respect to efficacy? Thank you.

Thank you.

So I will start and then over to Michelle. Um so again just to remind everyone we talk about a study, which have a 40 patients treated with scum 7 or an in maintenance settings, compared to 20% in Placebo, we're relying on uh, solid historical control and internal control, uh, comparing to Placebo. This is not a registration trial, but we are looking and we think this trial is well-built to allow us to understand if

From 71, there has been a monetary signal in this patient population after seeing a signal in the last line, Platinum resistance setting. And then upon success, this adaptive trial design will allow us to build and to continue to move forward, either to adding more arms to potentially accelerate approval. And Michelle, please add some color on that.

Okay, so the clinical trial is an exploratory study to allow us to determine the magnitude of the effect size of Khan. 71, it is very desirable for us to be able to demonstrate single aging activity, um, a an improvement of up to 3 months.

Looking forward to the totality of the data to be able to determine what next best steps would be.

Great. Thanks very much.

The next question is from esta, Gooden, Warden of St. Securities. Please. Go ahead.

Hey guys. Good morning. Thanks for taking my question. Um, so, uh, with Comm 902, this would test to be an unpartnered actually reduced digit antibody. Um, in the wake of, you know, new data coming up from uh the people we watching on Arcus and making read through here. So, uh, I know you've licensed the binder to AstraZeneca, but does that still give you flexibility to partner 902 with a separate company? Can you let us know about any restrictions or financial terms we should take into consideration?

Thanks Ashley. It's a great question.

So will license astrozen?

The right to use common 902 as part of their, by specific P1 and digits, and some other by specifics. But we fully own 902. We don't have any restrictions; we can either decide to move forward in our own trials, obviously, upon successful results by others to be a meaningful driver. We remind all of us that in the days, that the FC active digit initial, these were hundreds of millions of dollars of upfront deals.

And being the probably only monoclonal EPs reduced digit antibody, we believe that redos in 26 could bring meaningful interest back into digits, especially in the common 902. We have, again, we fully own it, so we can be fully opportunistic in whatever direction we would like to take this.

The next question is from Swamp of HC, when right? Please go ahead.

Good morning and David. Uh thanks for taking my questions. Um couple of quick questions. 1 is when we look at the tolerability profile of comp 71 you know um

How does that influence this potential use in combination therapies, especially in some of the less immune-inflamed tumors?

And uh, the other question is, uh, you know, when you saw the data from the P analysis, um, presented at as more. Um, there were some great 3 or higher uh treatment related Adverse Events about 16.7% or so. So how does how do you plan to, you know, uh, improve that safety um, in combination Therapies?

Sure sure. So firstly the tolerability of from 701 as a monotherapy is extremely well tolerated, in fact we didn't have any discontinuous due to Adverse Events and that pulled analysis when come 701 was used, as a single agent and in the, uh, triplet combination groups in the pulled analysis, the Adverse Events that were seen. That were grade 3 were in, in keeping, with the same frequency, seen in the respective, labels for both nalum and pin puzzle map. Um, given the tolerability of calm 71 on its own. We believe that it is very well set up for being able to be used as a monotherapy or as a combination with standard of care agents or with other novel, uh agents that are coming through the landscape.

Thank you. Thanks for taking the questions.

This concludes the Q&A session and competence investors conference call. Thank you for your participation. You may go ahead and disconnect.