Prepared remarks
Ladies and gentlemen, thank you for joining us today. Welcome to Compugen's First Quarter 2026 Results Conference Call. An audio webcast of this call is available in the Investors section of Compugen's website at www.cgen.com. 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. Lindsey, 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. Eran Ophir, President and Chief Executive Officer; and David Silberman, Chief Financial Officer. Dr. Michelle Mahler, 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. Eran Ophir, President and CEO.
Thank you, Lindsey, and good morning and good afternoon, everyone. Before I turn to our business update, I want to take a moment to formally welcome Lindsey, our new Head of Investor Relations and Corporate Communications to Compugen. Lindsey joined us with strong experience in Investor Relations, and we are thrilled to have her leading our communication with the investor community. Welcome, Lindsey, and we are 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 targeting PVRIG, which is an immune checkpoint with unique biology, much differentiated from other checkpoints, including PD-1 and TIGIT. 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, we presented a pooled analysis of clinical data showing that COM701 in monotherapy and combinations was well tolerated and showed consistent durable responses in patients with heavily pretreated platinum-resistant 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 earlier line patients with lower tumor burden, less compromised immune system and by that, increase the likelihood of these patients to benefit from COM701 unique mode of action. For this purpose, we initiated the MAIA-ovarian adaptive platform trial. In substudy 1 of this trial, COM701 is randomized as maintenance monotherapy versus placebo in patients with relapsed platinum-sensitive ovarian 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 the U.S. and Israel as well as sites from the ARCAGY-GINECO French cooperative group gives us confidence in our ability to complete enrollment on schedule for having the MAIA-ovarian median PFS data at interim analysis by Q1 2027. This patient population comprised of those progressing post PARP inhibitors and/or bevacizumab or who are not candidates for such treatments represent a significant unmet medical need with no current standard of care. We believe that clear prolongation of PFS in these patients could inform a registration path 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 later lines 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 rilvegostomig program. We remain confident in rilvegostomig's potential based on a differentiated bispecific antibody format in addition to its clinical and combination strategies. Last month, AstraZeneca presented multiple abstracts featuring rilvegostomig at the AACR Annual Meeting in San Diego, reinforcing our confidence in a differentiated design and growing potential. This includes preclinical data demonstrating potential opportunities for rilvegostomig as an IO backbone for combinations and also late-breaking data from the DESTINY-Gastric03 Phase II trial evaluating rilvegostomig in combination with a blockbuster ADC in HER2 and chemotherapy as first-line treatment for HER2-positive gastric cancers. This data showed promising antitumor activity and also demonstrated combinability of rilvegostomig from a safety perspective. Overall, these AACR publications continue to reinforce our confidence in rilvegostomig as AstraZeneca continues to advance it along 11 Phase III trials across multiple indications, including the recently opened trial in gastric in combination with the Claudin 18.2 ADC. With that, we are looking forward to the release of additional clinical data on rilvegostomig along the year, including at the next ASCO meeting at the end of the month. As a reminder, AstraZeneca previously estimated a non-risk-adjusted peak annual revenue potential of more than $5 billion for rilvegostomig and we are eligible for additional $195 million in future regulatory and commercial milestone payments plus mid-single-digit tiered royalties on sales. Moving to GS-0321, formerly known as COM503, our potential first-in-class anti-IL-18 binding protein antibody licensed to Gilead. GS-0321 represents a novel antibody approach to harness cytokine biology for the treatment of cancer, potentially overcoming the limitations of direct cytokine administration. The ongoing Phase I dose escalation trial continued to progress as we planned. As a reminder, we received to date $90 million from Gilead for these assets and are eligible to receive up to $758 million in additional milestone payments plus up to double-digit tiered royalties. Now to the early-stage pipeline and Unigen 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 and GS-0321. 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 AstraZeneca through which we received $65 million in nondilutive capital by monetizing only a small portion of our future rilvegostomig royalties. Our financial stability allows us to fully focus on advancing our pipeline and reaching key value-creating milestones with both our internal and partnered programs. And throughout all of this, we continue to benefit from a deeply talented and highly committed team here at Compugen. I'm proud of what we have built and energized by the opportunities ahead. With that, let me hand over to David for the financial update before we open the floor for Q&A.
Thank you, Eran, and I would like to add my own warm welcome to Lindsey as well. It is a pleasure to have you join the Compugen team, Lindsey, and we look forward to working together. I am pleased to say that we continue to advance into 2026 with a solid balance sheet and financial flexibility. Cash runway, assuming no further cash inflows, is expected to fund our operating plans into 2029. We anticipate using this runway to continue advancing 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. 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-term bank deposits and investments in marketable securities. Revenues for the first quarter of 2026 were approximately $2.2 million compared to approximately $2.3 million of revenue for the comparable period in 2025. The revenues in the first quarters of 2026 and 2025 reflect the recognition of both the upfront payment and the IND milestone payments from the license agreement with Gilead. 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 $5.8 million in the first quarter of 2025. The increase is mainly due to an increase in clinical expenses related to the MAIA-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 in 2025. For the first quarter of 2026, our net loss was approximately $7.7 million or $0.08 per basic and diluted share compared to a net loss of approximately $7.2 million 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.
Questions and answers
The first question is from Daina Graybosch of Leerink Partners.
Lindsey, welcome. Nice to see you here. Going into ASCO, I wonder if you could talk about more specifically the data sets Astra is going to present with rilvegostomig and help set the context for what we should expect to see? And are there benchmarks that we should be keeping in mind when we review the data set?
Sure. Thanks, Daina. So we're talking about two data sets, clinical data. Obviously, the actual data is not released yet, and I would be cautious on setting expectations on behalf of AstraZeneca. But overall, we talk about around the I-SPY trial testing rilvegostomig in adjuvant settings with Enhertu, which is by itself a blockbuster drug, which is very exciting to see these combinations. Again, I would be cautious about setting expectations, but I think looking again — and this is a platform trial — so really trying to look across not a randomized study, but trying to look about rilvegostomig versus other data sets. The combinability is again going to be very important to show, again, how the Fc-reduced format of rilvegostomig is easier to combine with such ADCs. And then the second set is the GEMINI-Hepatobiliary, which is in combination with chemotherapy. And here again, it will be good to see. I think it's a bit of a longer follow-up from what was reported before. So it'd be interesting to see about the long-term effect, how the PFS, how — 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 trial, there's an ongoing Phase III study ongoing. So I guess the comparison to historical control should be with caution and still probably is going to be made.
The next question is from Stephen Willey of Stifel.
Maybe you can just talk a little bit about how you're thinking about disclosing future development candidates that are discovered off the Unigen 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 one which continue to work to bring additional innovative assets like COM503, which is called today GS-0321. Specifically for that asset, it was right for this asset and for Compugen at these times to out-license it in preclinical 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 you're quoting on early assets only when it's ready for IND or only on the selection. 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 of the IL-18 binding protein other than the fact that it was another demonstration of how our computational platform can bring such innovative approaches, in that case, not only a first-in-class asset, but a first-in-class approach to harness cytokine biology for the treatment of cancer. And we are looking into different mechanisms of action, not necessarily similar to that, to bring, again, another innovative option that could really make a difference to patients.
The next question is from Leland Gershell of Oppenheimer.
Wondering if — could you remind us if the MAIA-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, given that this is an adaptive trial, would that mean that the interim data could inform some change to your design? Or would you simply keep going as planned?
Thank you, Leland. I think Michelle can take this one.
I'm happy to take this one, yes. So the MAIA-ovarian trial actually is not stratified according to PD-L1 subgroup. We are stratified by second versus third line of treatment. And in 1Q '27, when it reads out, 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 is going to depend on the totality of the data and also plans towards engaging with the regulators and steps towards a pivotal trial.
So comment regarding the PD-L1 stratification. I would like to remind you that PVRIG, probably because of its unique biology, we saw — in other indications, specifically ovarian cancer, we saw responses across PD-L1 positive and PD-L1 negative patients. So for now, we didn't see that necessarily like for other checkpoints that the PD-L1 subset is the one responding to COM701. And again, I think this is because that's unique biology, very much differentiated from TIGIT and PD-1. So again, not necessarily PD-L1 stratification is a typical discriminator here.
The next question is from RK of H.C. Wainwright.
So a couple more questions on the ovarian cancer trial. So now that you have all the sites active, any commentary on the enrollment status itself? And also because this is an event-driven trial, any commentary on the required events that needs to happen for the interim analysis? And the third question is, what are you assuming for the control arm PFS? And what sort of a hazard ratio do you need to see to consider that as a win?
Thanks, RK. Michelle, do you want to take it?
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 for 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, 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. So 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 three months or greater improvement over the benchmark PFS.
This concludes the Q&A session and Compugen's investor conference call. Thank you for your participation. You may go ahead and disconnect.