Q2 2026 Compugen Ltd Earnings Call

August 3, 2026

Speaker #1: Ladies and gentlemen, thank you for joining us today. Welcome to COMPUGEN's second quarter 2026 results conference call. At this time, all participants are in listen-only mode.

Operator: Ladies and gentlemen, thank you for joining us today. Welcome to Compugen's Q2 2026 Results Conference Call. At this time, all participants are in listen-only mode. 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.

Speaker #1: 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.

Speaker #1: I will now hand the call over to Lindsay Trickett, Head of Investor Relations and Corporate Communications, to begin. Lindsay, please go ahead.

Speaker #2: 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.

Lindsey Trickett: Thank you, operator. Good morning and good afternoon, everyone, and welcome to Compugen's Q2 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.

Speaker #2: 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 outcomes.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: These statements are subject to known and unknown risks and uncertainties. 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.

Lindsey Trickett: These statements are subject to known and unknown risks and uncertainties. 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.

Speaker #2: 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.

Speaker #3: Thank you, Lindsay, 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.

Eran Ophir: Thank you, Lindsey. Good morning, everyone. Q2 was a quarter of steady advancement. I am pleased with the progress we have made across every part of the company. Our science continues to advance in the clinic. 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 with new data at ASCO from the GEMINI-Hepatobiliary study in hepatobiliary cancer and the investigator-initiated I-SPY trial in breast cancer. Lastly, our collaboration with Gilead on GS-0321 continued to progress as planned. 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.

Speaker #3: Our science continues to advance in the clinic, and our partnerships are advancing on strong footing. Our Myovarine trial in platinum-sensitive ovarian cancer is progressing and on track for the interim analysis by Q1 2027.

Speaker #3: We're encouraged to see AstraZeneca continue to build momentum behind Rilvegostamib by initiating a new Phase 3 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.

Speaker #3: Lastly, our collaboration with Gilead on GS-0321 continued to progress as planned, and underpinning all of this is the same disciplined, data-driven approach that has always defined Compugen.

Speaker #3: Now let me take each program one by one, starting with our Holyhorn program, COMP701—a potential first-in-class anti-PVRG antibody. We continue to make good progress with MyOvarian, our sponsored, randomized, placebo-controlled adaptive platform trial evaluating COMP701 as maintenance monotherapy in patients with second- and third-line relapsed platinum-sensitive ovarian cancer.

Eran Ophir: 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 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 need. We anticipate the interim analysis with median progression-free survival data by Q1 2027. During this quarter, we were pleased to present a trial-in-progress poster on MAIA-ovarian at the ESMO Gynaecological Cancers Congress in Copenhagen. The poster underscored 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 mono and combination therapy in heavily pretreated platinum-resistant patients.

Speaker #3: In a setting with no approved maintenance treatment option and significant unmet need, we anticipate the interim analysis with median progression-free survival data by the first quarter of 2027.

Speaker #3: During this quarter, we were pleased to present a trial-in-progress poster on myovarian at the ESMO Gynecological Cancers Congress in Copenhagen. The poster underscored the strong biological and clinical rationale for evaluating COMP701 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 favorably observed with COMP701 in mono and combination therapy in heavily pretreated, platinum-resistant patients.

Speaker #3: As we prepare for the MyOvarian interim analysis, we have been keeping close tabs on the emerging external data to keep our own expectations anchored in the current clinical context.

Eran Ophir: 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 three months. While the patient population of these two trials is not identical and more heavily pretreated than the MAYA trial population, based on these data, we estimate the median PFS of the placebo control group in our trial to be approximately four 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.

Speaker #3: Two recent clinical trials in relapsed platinum-sensitive ovarian cancer, which included patients who have been pretreated with PARP inhibitors, bevacizumab, or both, have shown median progression-free survival for the control arm of less than three months.

Speaker #3: While the patient population of these two trials is not identical and is more heavily pretreated than the Maya trial population, based on these data, we estimate the median PFS of the placebo control group in our trial to be approximately four months.

Speaker #3: 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.

Speaker #3: If a patient relapses in less than six 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.

Eran Ophir: If a patient relapses in less than six months following platinum-based chemotherapy, they move into 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 six months after platinum-based chemotherapy. Achieving this threshold 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. MAYA is an exploratory trial designed to evaluate COM701 monotherapy and the magnitude of its effects.

Speaker #3: For the interim analysis, we define clinically meaningful success as COMP701 helping patients remain progression-free for at least six months after platinum-based chemotherapy. Achieving this threshold 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.

Speaker #3: Thereby improving quality of life, while preserving additional treatment options and potentially changing their disease course. Overall, we believe COMP701's anti-tumor activity will be best assessed by the totality of the data, comparing the treatment effects against our blinded, randomized control arm.

Speaker #3: Maya is an exploratory trial designed to evaluate COMP701 monotherapy and the magnitude of its effects. It is not a registrational trial powered to demonstrate a statistical difference between the treatment groups.

Eran Ophir: It is not a registrational trial powered to demonstrate a statistical difference between the two 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.

Speaker #3: Nevertheless, we believe that comparing COMP701 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 COMP701 and establish it as a potential backbone for drug combinations in this population.

Speaker #3: 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 COMP701.

Speaker #3: Turning to Rilvegostamib, 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.

Speaker #3: In the last week, AZ has added a 12th Phase 3 trial to the overall RILVE program, in participants with high-risk muscle-invasive urothelial carcinoma. In this trial, Rilvegostamib will be combined with Datroway, their approved TROP2 ADC, and tested in adjuvant settings against non-standard of care.

Eran Ophir: In the last week, AZ has added a 12th phase III trial to the overall rilve program in participants with high-risk muscle-invasive urothelial carcinoma. In this trial, rilvegostomig will be combined with Dato-DXd, their approved TROP2 ADC, and tested in adjuvant settings against standard of care. This new phase III trial, TROPiCS-04, follows the phase II TROPION-PanTumor03 study, in which rilve plus dato combo showed an encouraging efficacy and a manageable safety profile in metastatic urothelial carcinoma. We're also encouraged by the additional 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 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 readout from rilvegostomig.

Speaker #3: This new Phase 3 trial, TROPION Urothelial-04, follows the Phase 2 TROPION Pan-Tumor-03 study, in which the Rilve plus Datro combo showed encouraging efficacy and a manageable safety profile in metastatic urothelial carcinoma.

Speaker #3: We are also encouraged by the additional Rilve 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.

Speaker #3: In advanced biliary tract cancer, AstraZeneca presented an updated analysis from the JIMINI hepatobiliary study of Rilve in combination with chemotherapy in the first-line setting.

Speaker #3: This was the first overall survival data readout from Rilve, 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 Rilve across clinical trials. The profile continues to support Rilve combination potential. In comparison, historical trials for first-line BTC showed overall survival duration of less than 13 months. The data showed encouraging efficacy together with a manageable safety profile.

Eran Ophir: 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 RILVE across clinical trials, and the profile continues to support RILVE combination potential. In comparison, historical trial for first-line BTC showed overall 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 randomized data from the ongoing phase III trial in this setting will ultimately be needed to validate these findings. As AstraZeneca continues to advance rilvegostomig across its broad late-stage program, we believe this sustained investment reflects ongoing confidence in rilvegostomig.

Speaker #3: Both of which we view as promising signals in a setting of high unmet needs, while recognizing that longer follow-up and randomized data from the ongoing Phase 3 trial in this setting will ultimately be needed to validate these findings.

Speaker #3: As AstraZeneca continues to advance Rilvegostamib across its broad late-stage program, we believe this sustained investment reflects ongoing confidence in Rilvegostamib. As a reminder, AZ has previously guided that Rilve has a non-risk-adjusted peak-year revenue potential of over $5 billion, and we remain eligible for future milestones of $1.95 million and up to mid-single-digit tiered royalties tied to Rilvegostamib progress and success.

Eran Ophir: As a reminder, AZ has previously guided that RILVE has a non-risk adjusted peak year revenue potential of over $5 billion and we 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 milestones payment, plus single digit to low double digit tiered royalties.

Speaker #3: Moving to GS0321, formerly known as COMP503, our potential first-in-class anti-IL-18 binding protein antibody licensed to Gilead. GS0321 represents a novel antibody approach to harness cytokine biology for the treatment of cancer, potentially overcoming the limitations of direct cytokine administration.

Speaker #3: The ongoing Phase 1 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.

Speaker #3: Now, moving to our early pipeline fueled by Unigen, our AI and 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.

Eran Ophir: 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 known 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 in immuno-oncology innovation. With that, I will turn the call over to David to review the financials.

Speaker #3: As we have said before, our focus is not on using AI to optimize known biology, but on uncovering innovative opportunities to activate the immune system against cancer.

Speaker #3: Unigen has already discovered the targets of COMP701, COM902, and GS0321, and we remain committed to identifying and advancing the next generation of immuno-oncology innovation.

Speaker #3: With that, I will turn the call over to David to review the financials.

Speaker #1: 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.

David Silberman: Thanks, Eran, and thank you all for joining us today. We finished the H1 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 continuous investment in our early stage pipeline. Going into the details, I will start with our cash balance. As of 30 June 2026, we had approximately $125.3 million in cash equivalents, short-term bank deposits, and investment in marketable securities. Revenues for the Q2 2026 were approximately $2.6 million compared to approximately $1.3 million of revenue for the comparable period in 2025.

Speaker #1: 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 COMP701 platinum-sensitive ovarian cancer trial, MyOvarian, and to support the progression of GS0321 in the clinic, together with continued investment in our early-stage pipeline.

Speaker #1: 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.

Speaker #1: 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.

David Silberman: The revenues in Q2 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 Q2 2026 were in line with our plans. R&D expenses for Q2 2026 were approximately $6.3 million compared to approximately $5.6 million in Q2 2025. Our G&A expenses were approximately $2.3 million for Q2 2026 compared to $2.2 million for Q2 2025. For Q2 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 Q2 2025. With that, I will hand over to the operator to open the call for questions.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: With that, I will hand over to the operator to open the call for questions.

Speaker #2: Thank you. Ladies and gentlemen, at this time we will begin the question-and-answer session. If you have a question, please press star one.

Operator: Thank you. Ladies and gentlemen, at this time we will begin the question and answer session. If you have a question, please press star one. 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. Please stand by while we poll for your questions. The first question is from Stephen Willey of Stifel. Please go ahead.

Speaker #2: 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 #2: Please stand by while we pull up your questions. The first question is from Steven Wiley of Stifel. Please go ahead.

Speaker #1: Yeah, good morning. Thanks for taking the questions. I was just curious—it sounds like you've taken down your control arm assumption in the Maya trial by maybe about a month and a half.

Stephen Willey: Yeah, good morning. Thanks for taking the questions. Was just curious, so it sounds like you've taken down your control arm assumption in the MAIA-ovarian trial by maybe about a month and a half. 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? Would just be curious to get a better understanding as to your level of confidence now around this revised four-month number.

Speaker #1: 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? I would just be curious to get a better understanding as to your level of confidence now around this revised formal number.

Stephen Willey: 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? Would just be curious to get a better understanding as to your level of confidence now around this revised four-month number.

Speaker #3: Thanks, Michelle. Do you want to take this?

Eran Ophir: Thank you. Michelle, do you want to take this?

Speaker #4: Yeah, I'm happy to take it. Hi Steve, how are you doing? So, the two trials that we are referring to are European studies. One is TODOVA, recently presented at ASCO, and the other trial is a trial called OREO.

Michelle Mahler: Yeah, I'm happy to take it. Hi, Steve. How are you doing? The two trials that we are referring to are European studies. The one is TADOVA, recently presented at ASCO, and the other trial is a trial 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 population was 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. They also could have had multiple attempts of being treated with both bevacizumab or PARP inhibitors.

Speaker #4: Both trials were run in Europe and had similar patient populations, because they enrolled patients with platinum-sensitive ovarian cancer and were treated in the maintenance setting.

Speaker #4: However, the patient population was 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.

Speaker #4: They also included patients who have liver metastases, and so they also could have had multiple attempts at being treated with both bevacizumab or PARP inhibitors.

Speaker #4: So, due to this, these patients were actually more heavily pretreated than our MyOvarian trial, and their placebo control arms had a median PFS of 2.8 months.

Michelle Mahler: Due to this, these patients were actually more heavily pretreated than our MAIA-ovarian trial, and their placebo control arms 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 five and a half months, and these new updated trials who have a similar patient population. 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. We're making these adjustments based on emerging data.

Speaker #4: We anticipate that the actual benchmark is somewhere in between the historical data sets which we took from the original registration trials for the POP 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.

Speaker #4: 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.

Speaker #3: And maybe I could add that, you know, eventually we changed—the approximation is roughly around four months. But I think eventually what is most important for this trial is that that's why we have an internal randomized control placebo arm, and eventually we are comparing COMP701—40 patients treated in monotherapy—versus a placebo arm of 20 patients.

Eran Ophir: Maybe I could add that eventually, the approximation is roughly around 4 months. I think eventually, what is most important for this trial, that's why we have an internal randomized control placebo arm. Eventually, we're comparing COM701, 40 patients treated in monotherapy versus 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 eventually, the critical is the actual data on the trial comparing placebo to COM701 treatment.

Speaker #3: Whatever antitumor activity we see in the treatment arm is COMP701-driven. It's not a combination study. The assumptions for the placebo control are important, but eventually the critical point is the actual data from the trial comparing placebo to COMP701 treatment.

Speaker #1: Okay, and then maybe just quickly on GS0321. 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?

Stephen Willey: Yeah. 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? 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?

Speaker #1: And I guess monotherapy as well?

Speaker #3: Yes. So typically, with this kind of arrangement with pharma companies, we cannot say much. I would just remind you that, as you indeed said, we have dose escalation in mono, and in combination with PD-1. We also have backfill cohorts in the monotherapy, meaning more patients in the higher doses.

Eran Ophir: Yeah. It's typical with this kind of arrangement with pharma companies, we cannot say much. I would just remind that, as you indeed said, we have dose escalation in mono 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. We're looking in benchmark studies in this stage. I think it's reasonable to assume that everything is moving forward as planned. That means that probably we are already doing combinations and other expansions, for sure the backfill course, I would say. We cannot say precisely where we are and in which stage we'll disclose data. I think it's still early. Even if you look at other benchmark studies, phase I studies, 18 months into the study, it's a bit early for reporting data.

Speaker #3: And then the expansion phase. So, looking in benchmark studies, in this stage, yes, I think it's reasonable to assume that, you know, everything is moving forward as planned.

Speaker #3: That means that probably we are already doing combinations and other expansions, but for sure in the backfill course, I would say. But we cannot say precisely where we are and in which stage we'll disclose data.

Speaker #3: I think it's still early. I mean, even if you look at other benchmark studies, phase one studies, 18 months into the study—it's a bit early for reporting data.

Speaker #2: The next question is from Milan Gershel of Oppenheimer. Please go ahead.

Operator: The next question is from Mark Gersch of Oppenheimer. Please go ahead.

Operator: The next question is from [inaudible] of Oppenheimer. Please go ahead.

Speaker #5: Hi, good morning. Thanks, Eran, and the team. Just two questions for me. Just wondering, you know, with respect to the MyOvarian trial and the guidance for the data, just wondering, given the nature of the kind of, you know, changing assumptions and event-driven nature, could you see to the extent possible a readout that might come before the end of the year?

Mark Gersch: Hi. Good morning. Thanks, Eran and the team. Just two questions from me. Just wondering with respect to the MAIA-ovarian trial and the guidance for the data, just wondering, given the nature of the kind of changing assumptions and event-driven nature, could you see, to the extent possible, a readout that might come before the end of the year? Also want to ask, are there any particular biomarkers that you'll be looking at alongside the clinical PFS out-

[Analyst] (Oppenheimer): Hi. Good morning. Thanks, Eran and the team. Just two questions from me. Just wondering with respect to the MAIA-ovarian trial and the guidance for the data, just wondering, given the nature of the kind of changing assumptions and event-driven nature, could you see, to the extent possible, a readout that might come before the end of the year? Also want to ask, are there any particular biomarkers that you'll be looking at alongside the clinical PFS out-

Speaker #5: And I also want to ask, are there any particular biomarkers that you'll be looking at alongside the, you know, the clinical PFS outcome for future studies?

Eran Ophir: Thanks, Milan.

Eran Ophir: Thanks.

Mark Gersch: In future studies.

[Analyst] (Oppenheimer): In future studies.

Speaker #5: Thank you. Thank you.

Eran Ophir: Thank you.

Mark Gersch: Thank you.

[Analyst] (Oppenheimer): Thank you.

Speaker #3: Thanks, Milan. So for the first question, yes, the PFS of the placebo is now a bit shorter, but we are not changing our guidelines. And eventually, that's why we say the results will be by Q1 '27.

Eran Ophir: Thanks, Mark. For the first question, yes, the PFS of the placebo is now a bit shorter, but we're not changing our guidelines, and eventually, that's why we say the results will be by 2027. It is depending on the actual data on the study, and obviously, we will report it when the data is mature enough. Michelle want to add something for the second question about the biomarkers and other readouts you look at the study?

Eran Ophir: Thanks, [inaudible]. For the first question, yes, the PFS of the placebo is now a bit shorter, but we're not changing our guidelines, and eventually, that's why we say the results will be by 2027. It is depending on the actual data on the study, and obviously, we will report it when the data is mature enough. Michelle want to add something for the second question about the biomarkers and other readouts you look at the study?

Speaker #3: It is depending on the actual data from the study, and obviously, we will 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 you look at in the study?

Speaker #4: Sure. So, you know, 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.

Michelle Mahler: Sure. Our primary readout is progression-free survival. We don't 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. 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 unblind the data.

Speaker #4: 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 unblind the data.

Speaker #1: All right, terrific. Thanks very much.

Mark Gersch: All right, terrific. Thanks very much.

[Analyst] (Oppenheimer): All right, terrific. Thanks very much.

Speaker #2: The next question is from RK of HCM Remite. Please go ahead.

Operator: The next question is from RK of H.C. Wainwright. Please go ahead.

Speaker #5: Thank you. Good afternoon, Eran and team. This is RK from HCM Remite. One quick question: have you had any interactions with the FDA to see if the MyOvarian 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?

[Analyst] (H.C. Wainwright): Thank you. Good afternoon, 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 that we don't really have a drug approved?

Speaker #3: Thanks, RK.

Eran Ophir: Thanks, RK.

Speaker #4: 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.

Michelle Mahler: Okay, sure. 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 to you 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 again, part of the FDA guidelines that have recently come out. We're confident that with robust data, we will be able to have good engagements with the FDA.

Speaker #4: What I will say to you 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 Front Runner, 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, again, part of the FDA guidelines that have recently come out.

Speaker #4: So we're confident that, with robust data, we will be able to have good engagements with the FDA.

Speaker #5: Good, thanks. Is it possible for me to ask another question?

[Analyst] (H.C. Wainwright): Good, thanks. Is it possible for me to ask another question?

Speaker #3: Sure.

Eran Ophir: Sure.

Speaker #4: Sure.

[Analyst] (H.C. Wainwright): Sure. On the partnership with AstraZeneca, now that they have 12 clinical studies going on, I mean, 12 phase III studies going on, do you have an idea of what we should expect in terms of the earliest phase III readout that we could see? Also, this inclusion of the new trial, does it change either the schedule or composition of the $95 million in a milestone outstanding?

Speaker #5: On the on the on the partnership with AstraZeneca now that they have 12 clinical studies going on and 12 phase three studies going on, you know, do you have an idea of what we should expect in terms of the earliest phase three readout that we could see?

Speaker #5: And also, does this inclusion of the new trial—does it change, you know, either the schedule or composition of the $95 million, you know, milestone outstanding?

Speaker #3: So we'll start with the second question. This doesn't change; I mean, it's just another short-term goal in a new indication, in combination with ADC, which is again very promising, also based on what we have seen from the Phase 2 study.

Eran Ophir: We'll start with the second question. This doesn't change. I mean, just another shot on goal in a new indication in combination with ADC, which is again, very promising, also based on what you have seen from the phase II study. This goes for the agreement terms. Can you repeat the first question, please, RK?

Speaker #3: So this goes for the agreement terms. Comparing with the first question, please. Okay.

Speaker #5: You know, do you have any idea of, you know, which of the phase three studies we could see data from and, you know, anything on either the timing or what, you know, what data we could be seeing or from which study we could be seeing data?

[Analyst] (H.C. Wainwright): Do you have any idea of which of the phase III studies we could see data from? Anything on either the timing or what data we could be seeing, or from which study we could be seeing data?

Speaker #3: So, we could refer only to what AstraZeneca are saying. While they are continuously reporting data on phase two studies, as we see here in ASCO and at conferences, the phase three readouts, according to their guidelines, are after 27, meaning 28 and on.

Eran Ophir: We could refer only to what AstraZeneca are saying. While they are reporting continuously data on phase II studies with ADC in ASCO and in conferences, the phase III readouts according to their guidance is after 2027, meaning 2028. It doesn't mean that there couldn't be earlier interim analysis and other options, but the actual formal guidelines are after 2027 for the phase III studies.

Speaker #3: It doesn't mean that it couldn't be earlier interim analysis and other options, but the actual formal guidelines are after 27 for the phase three studies.

Speaker #5: Okay, thank you. Thanks for taking all my questions.

[Analyst] (H.C. Wainwright): Okay. Thank you. Thanks for taking all my questions.

Operator: This concludes the Q&A session and Compugen's Investor Conference Call. Thank you for your participation. You may go ahead and disconnect.

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