Compugen Ltd. (CGEN) Earnings Call Transcript

Ladies and gentlemen, thank you for joining us today. Welcome to Compugen's Second Quarter 2026 Results Conference Call. [Operator Instructions] 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 Second 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 Eran.

Thank you, Lindsey, and good morning, everyone. Q2 was a quarter of steady advancement and I'm pleased with the progress we have made across every part of the company. Our science continues to advance in the clinic and our partnerships are advancing on strong footing. Our MAIA-ovarian trial in platinum-sensitive ovarian cancer is progressing is on track for the interim analysis by Q1 2027. We're encouraged to see AstraZeneca continue to build momentum behind rilvogostamig by initiating a new Phase III trial in urothelial carcinoma and with new data at ASCO from the GEMINI study in hepatobilaric cancer and the investigator-initiated I-SPY trial in breast cancer. Lastly, our collaboration with Gilead on GS 031 continue to progress as planned. And underpinning all of this is the same disciplined, data-driven approach that has always defined Compugen. Now, let me take each program 1 by one, starting with our only on program COM701, a potential first-in-class anti-peg antibody. We continue to make good progress with MAIA-ovarian, our sponson randomized, placebo-controlled adaptive platform trial evaluating COM701 as maintenance monotherapy in patients with second and third line relapsed platinum-sensitive ovarian cancer in a setting with no approved maintenance treatment option and significant unmet needs. We anticipate the interim analysis with median progression-free survival data by the first quarter of 2027. During this quarter, we are pleased to present a trialing progress poster on my ovarian at the ESMO Gynecological Cancer Congress in Copenhagen. The poster underscores the strong biological and clinical rationale for valid in COM701 in this population, including the differentiated biology of the PVRIG pathway versus other checkpoints like PD-1 and TIGIT, it's high expression in ovarian cancer and the durable responses previously observed with COM701 in mono and combination therapy in heavily pretreated platinum-resistant patients. As we prepare for the MAIA-ovarian interim analysis, we have been keeping close tabs on the emerging external data to keep our own expectations incurred in the current clinical context. Two recent clinical trials in relapsed platinum-sensitive ovarian cancer that included patients who have been pretreated with PARP inhibitors or bevacizumab or both have shown median progression-free survival for the control arm of less than 3 months. While the patient population of these 2 trials is not identical and more heavily pretreated than the MAIA-ovarian population, based on these data, we estimate the median PFS of the placebo control group in our trial to be approximately 4 months. As a reminder, patients with a ovarian cancer are divided into either platinum-sensitive or platinum-resistant categories with the difference being the duration of their platinum-free interval. If a patient relapses in less than 6 months following platinum-based chemotherapy, they move into platinum-resistant category, where further platinum therapy is generally no longer proceed effective and treatment ships to nonplatinum options. For the interim analysis, we define clinically meaningful success as COM701 helping patients remain progression-free for at least 6 months after platinum-based chemotherapy. Achieving these thresholds maintains patient platinum sensitive for longer, delays their transition to platinum-resistant disease and give patients a valuable recovery rate for the intensity of chemotherapy, thereby improving quality of life, while preserving additional treatment options and potentially changing their disease course. Overall, we believe COM701's antitumor activity will be best assessed by the totality of the data comparing the treatment effects against our blinded, randomized control arm. MAIA is an exploratory trial designed to evaluate monotherapy and the magnitude of its effect. It is not a registrational trial power to demonstrate a statistical difference between the treatment groups. Nevertheless, we believe that comparing COM701 as a monotherapy against a placebo controlled will allow us to draw clear conclusions about its clinical activity. Looking ahead, we believe that clear prolongation of PFS in these patients could inform a registration path for COM701 and establish it as 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 where clinical signals were previously seen for COM701. Turning to Rilvegostomig, the PD-1-TIGIT bispecific antibody being advanced by our partner, AstraZeneca. The TIGIT component of which is derived from our fully owned Covenant program. In the last week, AZ has added a 12th Phase III trial to the overall program in participants with high-risk muscle-invasive urothelial carcinoma. In this trial, will be combined with Data, their approved TROP2 ADC and tested in adjuvant settings against out of care. This new Phase III trial, topioneuroterial 04 follows the Phase II tropism03 study in which rilve plus datocombo, showed an encouraging efficacy and a manageable safety profile in metastatic urothelial carcinoma. We're also encouraged by the addition of rilve data, AstraZeneca presented at 2026 ASCO Annual Meeting, which we believe continues to support the differentiated profile of this bispecific and its potential as an immuno-oncology backbone across multiple tumor types. In advanced pillar treat cancer, AstraZeneca presented an updated analysis from the GEMINI hepatroboliBLyRI study of Rilvi in combination with chemotherapy in the first-line setting. This was the first overall survival data result from Rilvi. And as AstraZeneca highlights in their ASCO investor call, the 16.8 months of overall survival was a clear example of prolonged stabilization of responses seen with relay across clinical trials, and the profile continues to support real combination potential. In comparison, historical trial for first-line BTC showed over survival duration of less than 13 months. The data showed encouraging efficacy together with manageable safety profile, both of which we view as promising signals in the settings of high unmet needs while recognizing that longer follow-up and customized data from the ongoing Phase III trial in this setting will ultimately be needed to validate this finding. As AstraZeneca continues to advance with Rilvegostomig, across its broad late-stage program, we believe this sustained investment reflects ongoing confidence in liprocostomyn. As a reminder, AZ has previously guided that rilvi has a nonrisk-adjusted peak year revenue potential of over $5 billion, a new remain eligible for future milestones of $195 million and up to mid-single-digit tied to Rilvegostomig progress and success. Moving to GS-0321, formerly known, our potential first-in-class anti-IL-13 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 continues to progress as planned. As a reminder, we have received $90 million so far from Gilead on these assets, and we are eligible to receive up to $758 million in additional milestones payment plus single digits to low double-digit tiered royalties. Now, moving to our early pipeline fueled via UniGen, our RI machine learning powered computational discovery platform, which has been developed and refined for more than a decade to identify novel drug targets and biological pathways rounded in human disease biology. As we have said before, our focus is not on using AI to optimize non-biology, but on uncovering innovative opportunities to activate the immune system against cancer. UNIGEN has already discovered the targets of COM701, COM902 and GS-0321, and we remain committed to identifying and advancing the next generation of immuno-oncology innovation. With that, I will turn the call over to David to review the financials.

Thanks, Eran, and thank you all for joining us today. We finished the first half of 2026 with a solid balance sheet and financial flexibility. Cash runway, assuming no further cash inflows, is expected to fund our operating plan 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. . Going into the details, I will start with our cash balance. As of June 30, 2026, we had approximately $125.3 million in cash, cash equivalents, short-term bank deposits and investment in marketable securities. Revenues for the second quarter of 2026 were approximately $2.6 million compared to approximately $1.3 million of revenue for the comparable period in 2025. The revenues in the second quarters of 2026 and 2025 reflect the recognition of portions of both the upfront payment and the IND milestone payment from the license agreement with Gilead. Expenses for the second quarter of 2026 were in line with our plans. R&D expenses for the second quarter of 2026 were approximately $6.3 million compared to approximately $5.6 million in the second quarter of 2025. Our G&A expenses were approximately $2.3 million for the second quarter of 2026 compared to $2.2 million for the second quarter of 2025. For the second quarter of 2026, our net loss was approximately $7 million or $0.07 per basic and diluted share compared to a net loss of approximately $7.3 million or $0.08 per basic and diluted share in the second 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 Stephen Willey of Stifel.

I was just curious, so it sounds like you've taken down your control arm assumption in the MAIA trial by maybe about 1.5 months. What do you know about the patient population from these 2 trials that you cited with respect to things like liver metastasis status that has been, I guess, just general patient eligibility criteria. And I would just be curious to get a better understanding as to your level confidence now around this revised 4-month number.

Michelle, do you want to take this? .

Yes, I'm happy doing. So the 2 trials that we are referring to are European studies. One is to Dova recently presented at ASCO. And the other trial is a trial called OREO. Both trials are run in Europe and had so the patient populations because they enroll patients with platinum-sensitive ovarian cancer and were treated in the maintenance setting. However, the patient population was not identical because the trials did not kept the prior lines of treatment. They included patients that had stable disease as well, which we don't. They also included patients who have liver metastases. And so they also could have had multiple attempts of being treated with both bevacizumab or POP inhibitors. So due to this, these patients were actually more heavily pretreated than our MAIA-ovarian trial. And their placebo control arm had a median PFS of 2.8 months. We anticipate that the actual benchmark is somewhere in between the historical data sets, which we took from the original registration trials for the PARP inhibitors, which was approximately 5.5 months and these new updated trials who have a similar patient population. And therefore, we've adjusted it to approximately 4 months. As such, we currently don't know who is allocated to which arm because our trial is blinded. So we're making these adjustments based on emerging data.

And maybe I could add that eventually, the approximation is roughly around 4 months. But I think eventually, what is most important for this trial is that, that's why we have an internal randomized controlled placebo arm, and eventually, we are comparing COM701 40 patients treated in monotherapy versus placebo arm of 20 patients, whatever antitumor activity you see, in the treatment arm. It's COM7-ondriven. It's not a combination study. And the assumptions for the placebo control are important, but eventually the critical is the actual data on the trial comparing placebo to COM701 treatment. .

Okay. And then maybe just quickly on GS-0. I guess you've been dose escalating now for, I guess, around 18 months or so. Have you had a conversation with Gilead about presenting some of the dose escalation data or you move into dose expansion? And is it safe to assume that you are now dose escalating both in combination with the PD-1 inhibitor and, I guess, monotherapy as well.

Yes. So typical with this kind of pharma companies, we cannot say much. I would just remind that as you -- this said, we have dose escalation in mono and in combination with PD-1. We also have backfill cores in the monotherapy, meaning more patients in the higher doses, and then, the expansion phase. So we're looking at benchmark studies in this stage. Yes, I think it's reasonable to assume that everything is moving forward as planned. That's been probably we are already doing combinations and other expansions. But for sure in the backfill cost, I would say. But we cannot say precisely where we are and in which state we'll disclose data. I think it's still early. I mean, if you look at other benchmark studies, Phase I studies 18 months into the study, it's a bit early for reporting data.

The next question is from Milan Gersha of Opening.

Just 2 questions for me. Just wondering with respect to the MAIA-ovarian on the guidance for the data. Just wondering, given the nature of the kind of changing assumptions and event-driven nature, could you see -- could you send to the extent possible readout that might come before the end of the year? And also I want to ask, are there any particular biomarkers that you'll be looking at alongside the clinical PFS?