Compugen Ltd. ($CGEN)

Ladies and gentlemen, thank you for joining us today. Welcome to Compugen's First Quarter 2026 Results Conference Call. [Operator Instructions] As a reminder, today's call is being recorded. I will now hand the call over to Lindsey Trickett, Head of Investor Relations and Corporate Communications to begin. Lindsay, please go ahead.

Thank you, operator. Good morning and good afternoon, everyone, and welcome to Compugen's First Quarter 2026 Financial Results Conference Call. With us today are Dr. Aron Ofer, President and Chief Executive Officer; David Silverman, Chief Financial Officer. Dr. Michelle Miller, Chief Medical Officer, will join us for the Q&A portion of the call. Before we begin, I'd 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 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 and that 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 you to 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'll now turn the call over to Dr. Erin Ofer, President and CEO.

Thank you, Lindsay. And good morning and good afternoon, everyone. Before I turn to our business update, I want to take a moment to formally welcome Lindsay, our new Head of Investor Relations and Corporate Communications to Compugen. Lindsay joined us with strong experience in Investor Relations, and we are thrilled to hover leading our communication with the investment community. Welcome, Lindsay, and we're glad to have you on board. Now let's start with our business update. 2026 is shaping up to be a significant year for Compugen, and I'm pleased to share our progress in the first quarter of 2026 as we continue executing on our strategic priorities. Starting with our fully owned clinical program, COM701, a potential first-in-class antibody target PVRIG, which is an immune checkpoint with unique biology much differentiated from other checkpoints, including PD-1 and agent. We believe this unique biology underlies the clinical activity demonstrated for COM701 in less inflamed indications such as ovarian cancer. As a reminder, at ESMO last year, represented the full analysis of clinical data showing that COM701 in monotherapy and combinations was well tolerated and showed consistent, durable responses in patient with heavily pretreated platinum-resistant of ovarian cancer. Based on these results, we decided to progress the development of COM701 and test it in earlier settings of ovarian cancer as a maintenance therapy in patients with relapsed platinum-sensitive ovarian cancer that responded to their most recent line of chemotherapy. The rationale is to allow COM701 to induce its antitumor activity in early relying patients with lower tumor burden, less compromised immune system and by that, increase the likelihood of these patients to benefit for COM701 unique mode of action. For this purpose, we initiated the marioviroAdaptiv platform trial. In such study 1 of this trial, Comsebralis randomized is maintenance monotherapy versus placebo in patients with relapsed platinum-sensitive or bearing cancer. We're actively enrolling patients in clinical sites across the United States, Israel and France. Having all sites open and enrolling, spanning leading academic centers in U.S. and Israel, as well aside from the cage Ginko French corporative group gives us confidence in our ability to complete enrollment on schedule for having the Mivan median PFS data at interim analysis by Q1 2027. This patient population comprised of those progressing post PARP inhibitors and/or EM overall lot candidates for sustreatment represent a significant unmet medical need with no current standard of care. We believe that clear prologation of PFS in these patients could inform a registration task for COM701 and make it a potential backbone for drug combinations in this population while also enabling a potential broader clinical development plan across earlier and netilize of ovarian cancer treatment as well as in other indications for clinical signals previously seen for COM701. In addition, we're happy to see our partner AstraZeneca's progress on their broad rilvugosomic program. We remain confident in real potential based on its differentiated bispecific antibody formats in addition to clinical and combination strategies. Last month, AstraZeneca presented multiple abstracts featuring yield at the AACR Annual Meeting in San Diego, reinforcing our confidence in the differentiated design and growing potential. This includes preclinical data demonstrating potential opportunities for Velvet as an IO backbone for combination and also laboring data from the Destiny gastric 3 Phase II trial evaluating relevant combination with the blockbuster ADC and HER-2 and chemotherapy as first-line treatment for HER2-positive gastric cancers. These data showed promising antitumor activity and also demonstrated combinability of real from a safety perspective. Overall, these ACR publications continue to reinforce our confidence in Relday as AZ continue to advance it along 11 Phase III trials across multiple indications, including the recently opened trial in gastric in combination with the closing 18.2 ADC. With that, we are looking forward to the release of additional clinical data along the year, including at the next ASCO meeting at the end of the month. As a reminder, AstraZeneca's previously estimated a nonrisk-adjusted peak annual revenue potential of more than $5 billion per Wheeler and were eligible for additional $95 million in future regulatory and commercial milestone payments plus mid-single-digit tiered royalties on sales. Moving to GS-0321, formally known as Confio, our potential first-in-class anti-IL-1 binding protein antibody licensed to Gilead. GS-0321, a novel antibody approach to any cytokine biology for the treatment of cancer, potentially overcoming the limitations of direct cytokine administration. The ongoing Phase I dotscalation trial continues to progress as we planned. As a reminder, we received to date $90 million from Gilead of this asset, on eligible to receive up to $758 million in additional milestone payments plus up to double-digit tildalties. Now to the early-stage pipeline, and enogen discovery engine. Beyond our clinical assets, we continue to invest in our early-stage immuno-oncology pipeline. UNIGEN our AI-powered computational target discovery platform has already discovered the targets of COM701, COM902, NGS. We remain committed to identifying and advancing the next wave of innovative programs, grounded in novel mechanism of action designed to activate the immune system against cancer. Importantly, we have a solid financial position with a cash runway expected into 2029 following the December 2025 transaction with AZ, through which we received $65 million in nondiluted capital by monetizing only a small portion of our future rebroalties. Our financial stability allows us to fully focus on advancing our pipeline and reaching key value-creating buystones with both our internal and partnered programs. And throughout all of this, we continue to benefit from a deeply talented and highly committed tumor Compugen I am proud of what we have built and energized but opportunities ahead. With that, let's hand over to David for the financial update before we open the floor for Q&A.

Thank you, Evan. And I would like to add my own warm welcome to Lindsay as well. It is a pleasure to have you join the Compugen Ltd. and Team Lindsey, and we look forward to working together. I am pleased to say that we continue to advance in 2026 with a solid balance sheet and financial flexibility. Cash runway, assuming no further cash inflows is expected to fund our parity plans into 2029. We anticipate using this runway to continue advancing our COM701 platinum-sensitive ovarian cancer trials, may ovarian and to support the progression of GS-0321 in the clinic, together with continued investment in our early-stage pipeline. Now going into the details, I will start with our cash balance. As of March 31, 2026, we had approximately $134.9 million in cash, cash equivalents, short and bank deposits and investments in marketable security. Revenues for the first quarter of 2026 were approximately $2.2 million compared to approximately $2.3 million of revenue for the comparable period 2025. The revenues in the third quarter of 2026 and 2025 reflects the recognition of posted of both the upfront payment and the IND milestone payments from the license agreement with inlet. Expenses for the first quarter of 2026 were in line with our plans. R&D expenses for the first quarter of 2026 were approximately $6.9 million compared to approximately in the first quarter of 2025. The increase is mainly due to an increase in clinical expenses related to my ovarian trial as well as higher drug supply costs supporting our trials. Our G&A expenses for the first quarter of 2026 were approximately $2.3 million compared to approximately $2.4 million for the comparable period 2025. For the first quarter of 2026, our net loss was approximately $7.7 million or $0.08 per basic can be look a share compared to a net loss of approximately $7.2 mill or $0.08 per basic and diluted share in the first quarter of 2025. With that, I will hand over to the operator to open the call for questions.

[Operator Instructions] The first question is from Lana Grab of [indiscernible] Partners.

Thank you for the question. Lindsay, welcome. Nice to see you here. Going into ASCO, I wonder if you could talk about more specifically the data sets going to prevent witruvagostimig? And helps set the context for what we should expect to see? And are there benchmarks that would -- that we should be keeping in mind when we review the data set?

Sure. Thanks, Dana. So we're talking about 2 DAS assets, clinical data. Obviously, the actual data is not released yet, and I would be cautious on setting expectations AstraZeneca but over, we talk about on the I-SPY trial in the testing will be cost to me in elegant settings with Synet, which is by itself a blockbuster drug, which is very exciting to see these combinations. . Again, I would be cautious about the expectation. But I think looking again, and this is a platform trial, so really trying to look across the nutrandomize study, but trying to look about driver versus other data sets. The combinability is again going to be very important and to show again how the Fc reduced format of rivagostamig is easy to combine with such ADCs. And then the second set is the Gimi which is in combination with chemotherapy. And here again, we'll be good to see. I think it's a bit of a longer follow-up from what was reported before. So we to see about the long-term effect of the PSS -- I'm not sure if there will be an OS data, but how the long-term effects are shaping, including the long-term safety in combination with chemo, having in mind that there is -- for this trade, there's an ongoing Phase III study ongoing. So I guess the comparison to sterocontrol should be with caution and still probably is going to be made.

The next question is from Stephen Wiley of St.

Maybe you can just talk a little bit about how you're thinking about disclosing future development candidates that are discovered off the Inogen platform. I think the IL-18 binding protein antibody wasn't announced until it was ready for clinical development. Is that kind of how we should expect incremental assets to emerge out of the pipeline once they're ready for an IND submission?

Thanks, Steve. So I think it's really dependent. Eventually, definitely, the biggest group in Compugen is the 1 that continue to work to bring additional innovative assets like COM, which is called today 031 -- specifically for that asset, it was right for this asset and for Compugen at these times to out license it in the clinical stage. So this also influenced the stage in which we disclosed it. It was relatively early. But it doesn't mean necessarily that we have any specific guidelines that we are porting on early assets only when it's ready for IND or only on its election. It really depends on the actual assets on the stage of derisking in which you want to start comment and committing. So again, I wouldn't learn too much from the story filing by the protein other than the fact that it was another demonstration of our competition platform can bring such innovative approaches in that case, not only first-in-class asset, but the first-in-class approach to highlight cytokinebology for equites cancer and we are looking into different MOAs not necessarily similar to that to bring again another innovative options that could really make difference to patients.

The next question is from Renan GershofOpeneier.

Wondering if -- could you remind us if the ovarian trial, is that stratifying for patients who are PD-L1 or PD-1 expression status. And I also want to ask when we see the interim data in the first quarter, will given that this is an adaptive trial, would that mean that the interim data could inform some change your design? Or would you simply keep going as planned?

Thank you, Live I think Michel can take this one. .

I think to take this one, yes. So the mylovarian trial actually is not stratified according to PD-L1 subgroup. We are stratified by second versus third-line treatment. And in '17. When a result, we have multiple options ahead of us in terms of adjustments to the trial. So we would consider adding additional arms and a lot of it's going to depend on the totality of the data and also plans towards engaging with the regulators and steps towards a pivotal trial.

Equal additional comment a little about the PDL1 certification, I would like to remind you that FIBRA probably because it's unique biology, we saw in other indications, specifically in ovarian cancer, we saw responses at pro-PD1-pst and PD-L1-negative patients. So for now, we didn't see not necessarily like for other checkpoints that the PD-L1 subset is the 1 responding to COM701. And again, I think this is because that unit biology, very much differentiated from PD-1 so again, not necessarily PD-L1 certification here.

The next question is from RK of H.C. Wainright.

So a couple of more questions on the ovarian cancer trial. So now that you have all these sites active, what is -- any commentary on the enrollment status itself and also because this is an event-driven trial, and any commentary on required events that needs to happen for the interim analysis? And the third question is, what -- what are you assuming for the control on PFS? And what sort of hazard ratio do you need to see to consider that as a win?

Michel, do you want to take .

Yes, sure. So firstly, with respect to enrollment, we're not commenting at this point in time, but I will say to you that we are on track our interim analysis as planned in the first quarter of 2027. And our participating investigators have a high level of engagement and are working really well with us. Regarding the events and the benchmarking. So the trial is an exploratory trial. And so at this point in time, we don't know the full magnitude of benefit, but the benchmark for the control arm from prior clinical trials in the second line and third line of maintenance in those trials where patients did not get treatment. The same patient population had a benchmark of approximately 5.5 months, although there was a range. So in some studies, it was as low as 3.8 months and others as high as 5.8 months. we're hoping to be able to show that there is meaningful single-agent clinical activity of COM701 and we've hypothesized that we would like to see a 3-month or greater improvement of the benchmark PFS.

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