管理層發言
Ladies and gentlemen, thank you for joining us today. Welcome to Compugen's Second 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 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 timelines 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 rilvegostomig by initiating a new Phase III trial in urothelial carcinoma and with new data at ASCO from the GEMINI study in hepatobiliary cancer and the investigator-initiated I-SPY trial in breast cancer. Lastly, our collaboration with Gilead on GS-0321 continues 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 one by one, starting with our wholly-owned program COM701, a potential first-in-class anti-PVRIG antibody. We continue to make good progress with MAIA-ovarian, our sponsored, 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 trial-in-progress poster on MAIA-ovarian at the ESMO Gynecological Cancers Congress in Copenhagen. The poster underscores the strong biological and clinical rationale for evaluating COM701 in this population, including the differentiated biology of the PVRIG pathway versus other checkpoints like PD-1 and TIGIT, its high expression in ovarian cancer and the durable responses previously observed with COM701 in monotherapy 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 anchored 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 two trials is not identical and more heavily pretreated than the MAIA trial 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 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 the platinum-resistant category, where further platinum therapy is generally no longer considered effective and treatment shifts to non-platinum 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 patients as platinum-sensitive for longer, delays their transition to platinum-resistant disease and gives patients a valuable recovery break from 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 COM701 monotherapy and the magnitude of its effect. It is not a registrational trial powered to demonstrate a statistical difference between the treatment groups. Nevertheless, we believe that comparing COM701 as a monotherapy against a placebo control 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 COM902 program. In the last week, AstraZeneca has added a 12th Phase III trial to the overall rilvegostomig program in participants with high-risk muscle-invasive urothelial carcinoma. In this trial, rilvegostomig will be combined with Datroway, their approved TROP2 ADC, and tested in adjuvant settings against standard of care. This new Phase III trial, TROPION-Urothelial04, follows the Phase II TROPION-PanTumor 03 study in which rilvegostomig plus Datroway combination showed encouraging efficacy and a manageable safety profile in metastatic urothelial carcinoma. We're also encouraged by the rilvegostomig data AstraZeneca presented at the 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 biliary tract cancer, AstraZeneca presented an updated analysis from the GEMINI-hepatobiliary study of rilvegostomig in combination with chemotherapy in the first-line setting. This was the first overall survival data result from rilvegostomig. 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 rilvegostomig across clinical trials, and the profile continues to support rilvegostomig combination potential. In comparison, historical trials for first-line biliary tract cancer showed overall survival duration of less than 13 months. The data showed encouraging efficacy together with a manageable safety profile, both of which we view as promising signals in settings of high unmet need while recognizing that longer follow-up and randomized data from the ongoing Phase III trial in this setting will ultimately be needed to validate this finding. As AstraZeneca continues to advance rilvegostomig across its broad late-stage program, we believe this sustained investment reflects ongoing confidence in rilvegostomig. As a reminder, AstraZeneca has previously guided that rilvegostomig has a non-risk-adjusted peak year revenue potential of over $5 billion and will remain eligible for future milestones of $195 million and up to mid-single-digit tiered royalties tied to rilvegostomig progress and success. 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 continues to progress as planned. As a reminder, we have received $90 million so far from Gilead on this asset, and we are eligible to receive up to $758 million in additional milestone payments plus single-digit to low-double-digit tiered royalties. Now, moving to our early pipeline fueled by Unigen, our AI/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 grounded 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 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. 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 investments 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.
分析師問答
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 two trials that you cited with respect to things like liver metastasis status, and I guess, just general patient eligibility criteria. And I would just be curious to get a better understanding as to your level of confidence now around this revised 4-month number.
Thank you. Michelle, do you want to take this?
Yes, I'm happy to take this. So the two trials that we are referring to are European studies. One is TEDOVA, recently presented at ASCO. The other trial is called OReO. Both trials are run in Europe and had similar patient populations because they enrolled patients with platinum-sensitive ovarian cancer and were treated in the maintenance setting. However, the patient populations were not identical because the trials did not cap 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 could have had multiple treatments with both bevacizumab or PARP inhibitors. 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 that have a similar patient population. 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.
Maybe I could add that the approximation is roughly around 4 months. But what is most important for this trial is that we have an internal randomized controlled placebo arm, and eventually we are comparing COM701 — 40 patients treated in monotherapy — versus a placebo arm of 20 patients. Whatever antitumor activity we see in the treatment arm is COM701-driven. It's not a combination study. The assumptions for the placebo control are important, but the critical element is the actual data on the trial comparing placebo to COM701 treatment.
Okay. And then maybe just quickly on GS-0321. 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 before 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. Typically, with this kind of arrangement with pharma companies, we cannot say much. I would just remind you that we have dose escalation in monotherapy and in combination with PD-1. We also have backfill cohorts 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. It's reasonable to assume that everything is moving forward as planned. That means that probably we are already doing combinations and other expansions, including backfill cohorts. But we cannot say precisely where we are and at which stage we'll disclose data. I think it's still early; even looking at other benchmark Phase I studies, 18 months into the study, it's a bit early for reporting data.
The next question is from Leland Gershell of Oppenheimer.
Just two questions for me. Just wondering with respect to the MAIA-ovarian trial and the guidance for the data. Given the nature of the changing assumptions and event-driven nature, could you see, to the extent possible, a 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 outcome for future studies?
Thanks, Leland. So for the first question, the PFS of the placebo is now a bit shorter, but we are not changing our guidance. We expect the results by Q1 2027. It depends on the actual data on the study, and obviously we're going to report it when the data is mature enough. Michelle, do you want to add something for the second question about the biomarkers and other readouts to look at in the study?
Sure. Our primary readout is progression-free survival. We don't yet have a specific biomarker selection strategy other than patient characteristics where we have excluded patients with liver metastases. The other thing to note is that in our earlier data, we did see activity in patients who were both PD-L1 positive and PD-L1 negative. So other than trying to enrich for more clinical attributes, we don't have a specific biomarker, and we do have an exploratory plan that we will analyze when we unwind the data.
The next question is from RK of H.C. Wainwright.
Eran and team, this is RK from H.C. Wainwright. One quick question. Have you had any interactions with the FDA to see if the MAIA-ovarian trial alone could support either an expedited or an accelerated path for approval, especially in this setting where we don't really have a drug approved?
Thanks, RK. Michelle?
Okay. Sure. So at this point in time, we have not had a meeting with the FDA. Once the trial reads out, we will follow all the appropriate regulatory steps. What I will say is we incorporated a lot of the guidelines from the FDA in designing the trial, and it's definitely in line with their guidance on Project FrontRunner, which is one of the reasons why we did go into an earlier line of treatment as well as using the Bayesian trial design, which is part of the FDA guidance that has recently come out. So we are confident that with robust data, we will be able to have good engagements with the FDA.
Is it possible for me to ask another question?
Sure.
Sure.
On the partnership with AstraZeneca, now that they have 12 clinical studies going and 12 Phase III studies ongoing, do you have an idea of what we should expect in terms of the earliest Phase III readout that we could see? And also, does this inclusion of the new trial change either the schedule or composition of the $95 million milestone outstanding?
I will start with the second question. This doesn't change. It's another short-term goal in a new indication in combination with an ADC, which is also very promising based on what we've seen from the Phase II study. So this does not change the agreement terms. Can you remind me the first question, please, RK?
Do you have any idea of which of the Phase III studies we could see data from and anything on either the timing? Or what data we could be seeing or from which study you could be seeing data?
We can refer only to what AstraZeneca is saying. While they are reporting continuously on Phase II studies this year at ASCO and in conferences, their guidance for Phase III results is after 2027, meaning 2028. That doesn't preclude earlier interim analyses or other options, but the formal guidance is after 2027 for the Phase III studies.
This concludes the Q&A session and Compugen's investor conference call. Thank you for your participation. You may go ahead and disconnect.