Q1 2025 Compugen Ltd Earnings Call
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Unknown Executive: Ladies and gentlemen, thank you for joining us today. Welcome to Compugen's first quarter 2025 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, www.cgen.com. As a reminder, today's call is being recorded.
Ladies and gentlemen, thank you for joining us today welcome to coffee brands first quarter 2025 results conference call at.
At this time, all participants are in listen only mode and the audio webcast of this call is available on the investors section of coffee Jones website Www Dot C. Gen Dot com.
As a reminder, today's call is being recorded.
Yvonne Naughton: I would now like to introduce Yvonne Naughton, Vice President, Head of Investor Relations and Corporate Communications. Yvonne, please go ahead.
I would now like to introduce Yvonne Naughton, Vice President head of Investor Relations and corporate communications.
Speaker Change: Please go ahead.
Yvonne Naughton: Thank you, operator, and thank you all for joining us on the call today.
Speaker Change: Thank you operator, and thank you all for joining us on the call today, joining me for comprehensive prepared remarks, our doctor not Colin Dyer, President and Chief Executive Officer, and David <unk>, Chief Financial Officer, Dr. Michelle mother, Chief Medical Officer, and Dr. <unk>, Chief Scientific officer will join us for the Q&A.
Yvonne Naughton: Joining me from Compugen for the prepared remarks are Dr. Anat Cohen Dayag, President and Chief Executive Officer, and David Silberman, Chief Financial Officer.
Yvonne Naughton: Dr. Michelle Mahler, Chief Medical Officer, and Dr. Eran Ophir, Chief Scientific Officer, will join us for the Q&A.
Yvonne Naughton: Before we begin, we would 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 programmes, 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, but 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 20F.
Speaker Change: Before we begin we'd like to remind you that during this call. The company may make projections or forward looking statements regarding future events.
Speaker Change: Development efforts under potential outcome, the company's discovery platform anticipated progress, sometimes there's always some timelines bar program financial and accounting related matters as well as statements regarding our cash position and cash runway.
Speaker Change: We wish to caution you that such statements reflect only the company's current beliefs expectations and assumptions, but actual results performance or achievements of the company may differ materially.
Speaker Change: 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.
Yvonne Naughton: The company undertakes no obligation to update projections and forward-looking statements in the future.
Speaker Change: Company undertakes no obligation to update projections and forward looking statements in the future and with that I'll turn the call over to enough.
Yvonne Naughton: And with that, I'll turn the call over to Anat.
Anat Cohen: Thank you, Yvonne, and a warm welcome to everyone joining our call today. To start, I would like to refer to the announcement we shared a few days ago regarding key leadership transitions at Compugen. After 15 years as President and CEO of the company, I am very happy to be assuming the newly created position of Executive Chair and to be handing the reins over to the very capable hands of Eran Ophir. Over the past year, we have accomplished a lot, including inventing our innovative clinical immunotherapy pipeline, establishing strategic collaborations, building a robust foundation with talented management teams, and ensuring a cash runway into 2027.
Speaker Change: Thank you Yvonne and a warm welcome to everyone joining our call today.
Speaker Change: To start I would like to refer to the announcements with shared few days ago regarding key leadership transitions at the computer.
Speaker Change: Just 15 year, President and CEO of the company I'm very happy to be assuming the newly created position of executive chair.
Speaker Change: And to be handing the reins over to the very capable hands Serrano sphere.
Speaker Change: Over the past year, we have accomplished a lot.
Speaker Change: Including advancing our innovative clinical immunotherapy pipeline, establishing strategic collaboration.
Speaker Change: Do you get a robust foundation with talented management team and ensuring our cash runway into 2027.
Anat Cohen: This is the right moment to pass the leadership to Eran, who has been my trusted partner and competent scientific leader for the past five years. We believe this combination of leadership ensures a solid foundation for the company's next phase of growth.
Speaker Change: This is the right moment to pass the leadership to Iran.
Iran: It's been my trusted partner.
Iran: In college and scientific leader for the past five years.
Iran: We believe this combination of leadership ensured the solid foundation for the company's next phase of growth.
Anat Cohen: I would also like to thank Paul Secri, who after 8 years will step down as Chair of the Board. Paul has been a great mentor to me and contributed significantly to the success we have achieved at Compugen.
Iran: I would also like to thank all exactly.
Iran: Oh after eight years, we stepped down as chair of the board.
Iran: Paul has been a great mentor to me and contributed significantly to the success we've achieved at Capri Jen.
Anat Cohen: On the call today, I will provide an update on progress we have made this quarter in our mission to transform the lives of cancer patients. In the first quarter of 2025, we continue to advance our early stage in clinical immuno-oncology pipeline. Starting with our potential first-in-class anti-PVRID antibody COM701, we initiated the first sub-trial of our adaptive platform trial comparing COM701 maintenance therapy to placebo in 60 patients with relapsed platinum-sensitive ovarian cancer. The patients progressing post-PARP inhibitors and or bevacizumab or who are not candidates for such treatments represent an area of unmet medical needs with no treatment options.
Iran: On the call today I will provide an update on progress. We have made this quarter you know our mission to transform the lives of cancer patients.
Iran: In the first quarter of 2025, we continue to advance our early stage and clinical immuno oncology pipeline.
Iran: I think with a potential first in class N P. P. B R. A G antibody com 701, we.
Iran: We initiated the first trial of our adaptive platform trial, comparing concept in one maintenance therapy to placebo.
Iran: In 60 patients with relapsed platinum sensitive ovarian cancer.
Iran: The patients progressing post stopping he'd be tour and all with a single mob.
Iran: Who are not candidates for such treatment.
Iran: Represents an area of unmet medical needs.
Iran: No treatment option.
Anat Cohen: Our study focuses on helping these women. With the support of our investigators, we are engaged with the site activation and are working diligently to proceed dosing the first patient. We intend to share interim analysis from this sub-trial in the second half of 2020 states. The clinical trial landscape is evolving following the success of ADCs in platinum-resistant ovarian cancer. And ADCs are also being evaluated now, earlier in the disease course, in patients with platinum-sensitive ovarian cancer, as replacements to chemotherapy and added to chemotherapy. We believe that advancing COM701 in the maintenance setting of platinum-sensitive ovarian cancer is where COM701 may present its potential advantages in terms of tolerability and durability.
Iran: Our study.
Iran: Of course, that's on helping D women.
Iran: With the support of our investigators were engaged with the site activation and are working diligently supersede dosing the first patient.
Iran: We intend to share interim analyses from desktop trial in the second half of 2026.
Iran: The clinical trial landscape is evolving following the successful phase D C in platinum resistant ovarian cancer.
Iran: And a D. C are also being evaluated now earlier in the disease course in patients with platinum sensitive ovarian cancer.
Iran: Platelets to chemotherapy.
Iran: And added to chemotherapy.
Iran: We believe that advancing concept that no one in the maintenance setting of platinum sensitive ovarian cancer.
Iran: We're confident in the one they presented potential advantages in terms of deliverability and durability.
Anat Cohen: As previously communicated, we believe that showing a three-month improvement over the median progression-free survival of the placebo would be clinically meaningful. Positive data has the potential to serve as a key catalyst in advancing a broader clinical development program to address the significant unmet medical needs.
Iran: As previously communicated we believe that showing a three month improvement over the median progression free survival of the placebo.
Iran: Would be clinically meaningful.
Iran: Positive data.
Iran: Has the potential to serve as a key catalyst in advancing our broader clinical development program to address significant unmet medical need.
Anat Cohen: Moving next to the Physic Landscape. Despite failures in the TGIT space, it is notable that companies with FC-inactive anti-TGIT, like AstraZeneca and Arcus Gilead, are advancing their program. We have consistently advocated that SPE-inactive antibodies may serve as the better antibody format for targeting tick-borne diseases. In line with this, current clinical trials suggest that FDA-inactive anti-TG may have a safety advantage in certain patient populations, which could support a potential efficacy advantage due to patient durability on study treatment.
Iran: Moving next to the digital landscape.
Iran: Despite failure in the <unk> space.
Iran: It is notable that companies with SC enact events at T. G I.
Iran: Astrazeneca and August Gilead are advancing their programs.
Iran: We have consistently advocated did ask the inactive antibodies may serve as the better antibody format or targeting T. G.
Iran: In line with this time.
Iran: Clinical trials suggest that S. The inactive and T. J may have a safety advantage in certain patient populations, which could support.
Iran: Attention of secrecy advantage.
Iran: Patients' durability on study treatment.
Anat Cohen: With the multiple phase three failures in TGIT studies, despite positive phase two randomized studies, we believe that only a success in one of the upcoming phase three trials could validate the TGIT antibodies as a drug class, change the market sentiment, and open new opportunities for us as one of the few companies that have an FTE-inactive clinical stage TGIT antibody. Clinically, we continue to believe that TGPD1 blockade may need to be combined with a PVRIG inhibitor to expand their use to lessen flame PD-L1 low tumors. So positive TGP-1 data by others may present additional opportunities for us.
Iran: With the multiple phase three failures and ticket studies.
Iran: Despite pause if you'd face to randomized studies, we believe it's only a success in one of the upcoming phase III trial.
Iran: But if they did tejas antibodies as a drug class.
Iran: Change the market sentiment and open new opportunities for us as one of the few companies that have an F. C. In active clinical stage T. D N G gauzy.
Iran: Clinically.
Iran: Continue to believe the PD, one blockade may need to be combined with a few here igene he'd Ito judge Fender you less inflamed PDL one low tumor.
Iran: So positive T. G PD, one data by either May present additional opportunities for them.
Anat Cohen: In addition, our partner AstraZeneca has the largest ongoing phase 3 program in the TG space. They have most recently initiated their 10th phase 3 clinical trial with Rilzagast-Omic, their PD-1-TG-Bi-specific, the TG component of which is derived from RCOM-903. Since our last report in March 2025, AstraZeneca has initiated three additional phase three trials in Lung, Gastric, and now also in a Neutromer type and Dometrial. These new tribes are evaluating real vagostomy gizmonotherapy and combination therapy. The potential commercial opportunity for Real Vegas to make is substantial, with AstraZeneca estimating non-risk-adjusted PQ revenue targets of more than $5 billion.
Iran: In addition, our partner Astrazeneca has the largest ongoing phase III program in the did you say.
Iran: They have most recently initiated their 10th Phase III clinical trials with really the golf to make their PD one teaching bispecific.
Iran: The ticket component of which is derived from our 902.
Iran: Since our last report in March 2020 five.
Iran: Then it got has initiated.
Iran: Additionally, phase III trials in lung gastric and now also in a neutral more tight endometrial.
Iran: These new trials are evaluating rid of Augusta League as monotherapy.
Iran: <unk> combination therapy.
Iran: The potential commercial opportunity for with regards to make its abstention with astrazeneca estimating non risk adjusted PQ revenue target with more than $5 billion.
Anat Cohen: In lung cancer alone, the eligible lung cancer patient population across G7, based on 2025 epi data, is estimated by AstraZeneca to be over half a million patients. AstraZeneca's broad development strategy for rilvigastamib to replace existing PD-1, PD-L1 inhibitors represents a significant potential revenue source for us as we're eligible for both future months on payment and meet single-digit tiered royalties on future sales. Coming up at ASCO 2025, AstraZeneca plans to present, as a poster, the first rilvigastamig ADC combination data from the Phase II Tropion Lung O4 trial, evaluating frontline rilvigastamig in combination with datadxd in non-swollen cancer.
Iran: In lung cancer alone.
Iran: Eligible lung cancer patient population across G. Seven.
Iran: Based on 2020 fives Etsy data he estimated by astrazeneca to be over half a million patients.
Iran: Astrazeneca broad development strategy for we've begun to make to replace existing PD. One PDL one inhibitor represents a significant potential revenue source for us as we're eligible for both future milestone payments and mixing as D. G tiered royalties on future sales.
Iran: Coming up at a school 2025, Astrazeneca plans to present a poster. The first really regard for me gave you see combination data from the phase two truck young lung Oh four trials.
Iran: Aging frontline will begun to me in combination with death, a D V in non small cell lung cancer.
Anat Cohen: AstraZeneca also plans to present a poster with the first data from the Phase II Gemini hepatobiliary trial evaluating frontline Rilzagastamig in combination with chemotherapy in treatment-naive biliary tract cancer.
Iran: Astrazeneca also plans to present, a poster with the first data from the phase two Gemini Hepatobiliary trial if.
Iran: Evaluating frontline reads Augusta League in combination with chemotherapy in treatment naive biliary tract cancer.
Anat Cohen: Moving next to GF0321, formerly known as COM503, a potential first-in-class anti-IL-18 binding protein antibody, likeness to Gilead. GS0321 represents a novel way to harness IL-18 pathway biology for the treatment of cancer, potentially avoiding the challenges presented by administration of therapeutic cytokines. The Phase I trial is progressing as planned.
Iran: Moving next to G. S 0321, formerly known as contextual free a potential first in class anti Ige binding protein antibody licensed to Gilead.
Iran: Jean Bua for each one represents a novel way to harness the IL 18 pathway biology.
Iran: For the treatment of cancer potentially avoiding the challenges presented but ministration of therapeutics cytokine.
Iran: The phase one trial is progressing as planned.
Anat Cohen: Finally, beyond our clinical stage program, our teams are committed to progressing our extensive, innovative, and differentiated early-stage pipeline focused on potential first-in-class drugs and novel mechanisms of action aiming to address various mechanisms to enhance anti-cancer immunity. With a diverse pipeline and strong focus on execution in 2025, we believe Compugen is well positioned for growth.
Iran: Finally.
Iran: Beyond our clinical stage program.
Iran: Teams are committed to progressing our extensive innovative and differentiated early stage pipeline.
Iran: Pakistan potential first in class drugs and novel mechanisms of action aiming to address various mechanism.
Iran: Hence anti cancer immunity.
Iran: We did diverse pipeline and strong focus on execution in 2025, we believe comprehend is well positioned for growth.
Anat Cohen: KESS Runway, assuming no further cash inflows, is expected to fund our operating plans into 2027, and we anticipate using this runway to advance our COM71 platinum-sensitive ovarian cancer trials and to support the progression of GS0321 in the clinic, together with continuing investment in our early-stage research pipeline. Of course, none of this would be possible without our highly committed, talented team here at Compugen, who continuously perform at the highest levels of excellence.
Iran: Cash runway assuming no further cash inflow is expected to fund our operating plan into 2027, and we anticipate using this runway for advent theyre called seven one platinum sensitive ovarian cancer trial and to support the progression of G. S zero three to one.
Iran: In the clinic together with continued investment in our early stage research pipeline.
Iran: Of course, none of this would be possible without our highly committed talented team here at the coffee Jin Hui.
Iran: Who continuously.
Iran: At the highest level of excellence.
Anat Cohen: I'm excited for 2025 to be another year of advancing our efforts to make a meaningful impact on cancer patients' lives.
Iran: I'm excited for 2025 to be another year of advancing our efforts to make a meaningful impact on cancer patients' lives.
David Silberman: With that, I will hand over to David for the financial update before we open the floor for Q&A. Thank you, Anat. I am delighted to say that we are advancing into 2025 with a solid balance sheet with no debt and with a cash runway to support our operating plans into 2027. Our cash runway takes into account the planned development of our clinical assets and continued investment in our early innovative pipeline and does not include any additional potential cash inflow.
Iran: With that I will hand over to David for the financial update before we open the floor for Q&A.
David: Thank you and that I am delighted to say that we're advancing in 2025 with a solid balance sheet with no debt and we as a cash runway to support our operating plan into 2027.
David: Our cash runway takes into accounts the plane developmental forward clinical assets and continued investment in our early innovative pipeline and does not include any additional potential cash inflows.
David Silberman: Going into the details, I will start with our cash balance. As of March 31st, 2025, we had approximately $103.7 million in cash, cash equivalents, short-term bank deposits, and investment in marketable securities. Revenues for the first quarter of 2025 were approximately $2.3 million, compared to approximately $2.6 million of revenue for the comparable period in 2024. The revenues in the first quarter of 2025 reflect the recognition of portions of both the upfront payment and the milestone payment from the license agreement with Gilead, while in the first quarter of 2024, they reflect portions of the upfront payment from the license agreement with Gilead.
David: Going into the details I will start with our cash balance as of March 31, 2025, we had approximately $203.7 million in cash cash equivalents told him bank deposits and investments in marketable securities.
David: Revenues for the first quarter of 2025 were approximately $2 $3 million compared to approximately $2 $6 million of revenue for the comparable period in 2024 the.
David: The revenues in the first quarter of 2025 reflects the recognition of portions of both of the upfront payments and milestone payments from the license agreement with Gilead, while in the first quarter also in 'twenty four they reflect a portion of the upfront Big man from the license agreement with Gilead.
David Silberman: Expenses for the first quarter of 2025 were in line with our plan. R&D expenses for the first quarter of 2025 were approximately $5.8 million compared to approximately $6.4 million in the first quarter of 2024. Our DNA expenses for both the first quarter of 2025 and 2024 were approximately $2.4 million. For the first quarter of 2025, our net loss was approximately $7.2 million or 8 cents per basic and diluted share compared to a net loss of approximately $7.3 million or 8 cents per basic and diluted share in the first quarter of 2024.
David: Expenses for the first quarter of 2025 were in line with our plan.
David: R&D expenses for the first quarter of 2025 were approximately five points.
David: This compares to approximately $6 $4 million in the first quarter of 2024.
David: Our G&A expenses for both the first quarter of going 'twenty, five and 'twenty 'twenty four were approximately $2 $4 million.
David: For the first quarter of 2025, our net loss was approximately $7 $2 million or eight cents per basic and diluted share compared to a net loss of approximately seven $3 million or eight cents per basic and diluted share in the first quarter of 'twenty 'twenty four with that I will hand over to the operator to open the call for <unk>.
Unknown Executive: With that, I will hand over to the operator to open the call for questions. Thank you. Ladies and gentlemen, at this time, we will begin the question and answer session. If you have a question, please press star 1. If you wish to decline from the polling process, please press star 2. If you are using speaker equipment, kindly lift the handset before pressing the numbers. Please stand by while we poll for your questions.
David: Sure.
Speaker Change: 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.
David: Please standby, while we poll for your questions.
David: The first question is from Dana Gray, which from Leerink partners.
Daina Graybosch: The first question is from Daina Graybosch from Learinc Partners. Daina.
David: Saying that I'm.
Daina Graybosch: Two questions for me, more on the competitive landscape. Merck recently announced that Keynote B96, which is a trial phase 3 studying pembrolizumab and platinum-resistant ovarian cancer was successful and hit on overall survival in patients that have tumors that express PD-L1.
Speaker Change: Two questions for me more on the competitive landscape, Merck recently announced that cannot be nine six.
David: Which is a trial phase III studying pampa was a mab.
David: And resistant ovarian cancer or successful and hit on overall survival in patients that have tumors that express PDL, one I wonder if you could talk about that success and how.
Michelle Mahler: I wonder if you could talk about that success and how that could impact if, you know, we haven't seen the results, if they ultimately launch Pembro in that setting, your strategy in ovarian cancer, and then I have a follow-up.
David: How that could impact it.
David: We haven't seen the results if they ultimately launch hambro in that setting.
David: Our strategy in ovarian cancer, and then I have a follow up.
Michelle Mahler: Michelle, would you like to refer to this? Sure. I'd be happy to refer to it.
David: Michelle would you like to refer to this sure.
Michelle: Sure I'd be happy to to referred to it. Thanks for the question Dana Yes. So the study is in platinum resistant ovarian cancer. It's insured line. So it is in an earlier stage setting of patients in the disease process, whereas all studies and in platinum sensitive, but we're also looking at secondary.
Michelle Mahler: Thanks for the question, Daina. Yes, so this study is in platinum-resistant ovarian cancer. It's in third line. So it is in an earlier stage setting of patients in the disease process, whereas our studies in platinum-sensitive, but we're also looking at second and third line patients. So I'm quite encouraged by their announcement, because it means that there is benefit being seen by adding an immune checkpoint inhibitor to standard of care agents. And in the event that our study demonstrates activity, it opens up additional opportunities to be able to combine ALCOM 701 in these settings and also help drive taking it further to a broader population.
Michelle: And third line patients so I'm quite encouraged by their announcement because it means that there is benefit being seeing by adding an immune checkpoint inhibitor to a standard of care agents and in the event that our study demonstrates activity it opens up.
Michelle: Additional opportunities to be able to combine.
Michelle: The outcome 701 in these settings and also helped drive taking it further to a broader population.
Unknown Executive: Great.
Speaker Change: Great and then I Wonder you know you talked about changes in our Chicago complex that I Wonder if you could talk about your interpretation of Roche's skyscraper one data what about the data specifically.
Unknown Executive: And then I wonder, you know, we talked about TIGIT and FC-competent or incompetent.
Unknown Executive: I wonder if you could talk about your interpretation of Roche's Skyscraper 1 data. What about the data specifically gives you confidence that the failure of that TIGIT was due to its FC-competency and not simply that TIGIT antagonism adds incremental clinical benefit?
Michelle: Gives you.
Michelle: I'm confident that the failure of that change was due to its F C competency and not simply that country antagonism adds incremental clinical benefit.
Unknown Executive: Okay, so I'm going to make, oh, you're going to take it, Eran. Okay, go ahead. No, I'd go after you. Sure.
Michelle: Yes, Okay. So I'm gonna make Oh, you Gotta taken everyone's Okay go ahead.
Michelle: No I'd go off to you.
Eran Ophir: So, yeah, what we see is, I think, what we tend to see from this did you try with the FCX. we see that even in this trial, even all the complication of the FCA active and high disconsideration rate, we still see activity. We definitely see numerical activity. But overall, in this study, in the patient population that they chose, also they had higher rate of brain metastasis in this patient compared to previous trials and CT-SCAPE, for example.
Michelle: Sure.
Michelle: Yeah, what we see is I think what we tend to see from this to Detroit.
Michelle: See you.
Michelle: Even in this trial, even though the complication of their CX, even high discontinuation rates, we still see activity, we definitely see numerical activity, but overall in this study in the patient population that they chose also they had higher rates of brain metastasis anticipations compared to previous trials.
Michelle: And cityscape for example.
Michelle: The.
Eran Ophir: the statistical plan maybe was a bit challenging, maybe also the number of patients. So I think, no, we know that TIGIT, in contrast to mice, TIGIT blockade is not causing to complete melting of all tumors. But we know it's active.
Michelle: The statistical plan, maybe it was a bit challenging maybe also the number of patients. So I think we know the digits in contrast to mice digits bouquet is not causing to complete multiple tumors.
Michelle: But we know it's active.
Eran Ophir: And now, the details matter. So if you have an active FC and you have a high discontinuation rate, it matters. As a reminder, ourself, AstraZeneca, our goods have a non-active FC.
Patrick: This is Patrick so do you have an active C diff.
Speaker Change: Consideration right it's matters.
Speaker Change: And Oh self Astrazeneca argues that the known occupancy and then also if any.
Eran Ophir: and then also if the right patient population is critically important, the statistical design. So I think what you are encouraged to see, again, definitely an activity of digits that when it's added to PD-1, we see numerically that there is longer overall survival, longer PFS, higher ORR. It was not sufficient in this study, in this size, in this patient population, and with the high discontinuation rate, typical to have active digits, to lead to approval. And we definitely are eager to see how the coming trials with FC non-active digits will turn out.
Speaker Change: Our tissue population is critically important the statistical design. So I think what you are encouraged to see again.
Speaker Change: <unk> seen activity of digits that we need to edit to PD, one we've seen numerically the deltas longer over survival longer PFS high although it was not sufficient in this study and this size and this patient population and it was the high discontinuation rates typical.
Speaker Change: To lead to approval and we definitely are used to see how the coming trials with FCA not uptick digits will turn up.
Michelle Mahler: Michelle. Yeah, so I agree with also. Yeah, so I was going to agree with what Eran said. And I think that they are definite nuggets in terms of the type of patients between the Cityscape study and the Skyscraper study. And I think the populations were not different, sorry, were not the same. So the activity seen in the one study did not translate into the second study. So I think there's still more to be learned. And again, I think that the discontinuation rate in Skyscraper one, as well as the number of patients with metastases to the brain and liver, probably also, you know, impacted their their data and outcome.
Speaker Change: Sure.
Speaker Change: Yeah.
Yeah right.
Speaker Change: Greg was also.
Speaker Change: Yeah. So it is going to agree with what Aaron said and I think that they are definite nuggets in terms of the type of patients between the cityscape study and the <unk> skyscraper studying I think the populations went up different Oh, sorry. It went up the same so the activities seen in the one study did not translate into the second.
Speaker Change: Studies, So I think there's still more to be learned and again I think that the discontinuation rate in skyscraper one as well as the number of patients with metastasis to the brain and liver are probably also you know impacted their their data and outcomes.
Michelle Mahler: And I'll add just one more thing, that I think, you know, that the safety or the tolerability of the FC disabled may also turn these assets, it may not only affect the, you know, the discontinuation and then the efficacy, but it may also turn them to be more combinable. And I think that with the next studies that are being done, testing also combinations with chemo, combinations with ADCs, that may be very relevant.
Speaker Change: And I'll add just one more thing that I think you know that the safety or tolerability of the SC disabled may also turn visa. So it's not that it may not fully affect that you know the discontinuation and then the efficacy.
Speaker Change: But it also turns out to be more people buying a buzz and I think then we didn't have studies that are being done testing also combinations with chemo combinations with ADC.
Speaker Change: Maybe very relevant and on this front I think that only phase III data, we'll make a difference in the field and I think that we have a long phase two data that are that are showing and randomized studies that are showing just.
Michelle Mahler: And on this front, I think that only phase 3 data will make a difference in this field. And I think that we have a lot of phase 2 data that are showing in randomized studies that are showing that the TG addition to PD-1 adds value. And I think that the only thing that will matter is to see a very good phase 3 data. Hopefully, with the FC disabled, either from ARCWS first and then from AstraZeneca beyond 26, only positive data will change the sentiment, I believe.
Speaker Change: The teachers to different opinion, one adds value and I think that the only thing that we measure is to see very good phase III data.
Speaker Change: Hopefully we need Fcb's abled, either from the August 1st and then Tom I suppose I call it beyond 'twenty six.
Speaker Change: The positive data we changed the sentiment I believe.
Speaker Change: Great. Thank you guys.
Speaker Change: Yeah.
Rohan Mathur: The next question is from Rohan Mathur of Oppenheimer. Please go ahead. Hi, thanks for taking the question.
Speaker Change: The next question is from ROA in Mysore of Oppenheimer. Please go ahead.
Hi, Thanks for taking the question. This is rolling on for leasing there. So just a couple for me.
Rohan Mathur: This is Rohanan for Leading Your Show. of Platinum Resistance. What would you like to see from a clinically meaningful perspective on PFS benefits? So to answer your first question, we will definitely be collecting data to be able to evaluate the tumor microenvironment. We do have a biomarker plan, but I'm not going to comment further on the details since it's not in the public domain. And regarding the maintenance setting, so in platinum sensitive, which is where our maintenance study is taking place, we do know from multiple phase three benchmark studies, both for bevacizumab as well as for the POP inhibitors, the progression-free survival in patients on all of those placebo arms, whether they were in second line treatment or third line treatment, tended to range between 5.4 months and 5.8 months.
Speaker Change: One of them do you plan to collect data on the tumor microenvironment features from the 701 study like PD lone expression or send signatures and the other would be.
Speaker Change: Are you thinking about the maintenance setting for platinum resistant patients what would you like to see it from a clinically meaningful meaningful perspective on PFS benefit. Thank you.
Speaker Change: So the first to answer your first question, we will definitely be collecting data to be able to evaluate.
Speaker Change: The tumor microenvironment, we do have a biomarker planned, but I'm not going to comment further on the detail since it's not in the public domain and regarding the maintenance setting so in platinum sensitive, which is where our maintenance study is taking place we do know from <unk>.
Speaker Change: Poems stage three benchmark studies, both for Bevacizumab as well as for the PARP inhibitors, the progression free survival in patients on all of those placebo arms, whether they were in second line treatment or third line treatment tended to range between 5.4 months and.
Speaker Change: The five eight months there was one outlier of 3.8 months, which had to do with the baseline genetic makeup of the patient population. So you know, we feel that and improvement that exceeds around three months would be clinically.
Rohan Mathur: There was one outlier of 3.8 months, which had to do with the baseline genetic makeup of the patient population. So, you know, we feel that an improvement that exceeds around three months would be clinically meaningful. Great, thank you.
Speaker Change: Meaningful.
Speaker Change: Great. Thank you.
Asthika Goonewardene: The next question is from Asthika Goonewardene of Truist, please go ahead. Hey, guys. Good morning. Thanks for taking my questions. Just want to tag on to Daina's question about B9-6. Can you remind us, does 701 work with that? Have you seen specifically activity in PD-L1 positive patients? Just wondering if, I know B9-6 is in the platinum resistance setting, but I'm just wondering if you had seen that and maybe we can make some read-throughs as to what the combinability would look like in the event that, you know, it gets PD-L1 approved in the late-life setting, too.
Speaker Change: The next question is from Asti cargo in awarding of Truest. Please go ahead.
Speaker Change: Yeah.
Speaker Change: Hey, guys. Good morning, Thanks for taking my questions just wanted to tack onto that last question about B nine six.
Speaker Change: Can you remind us.
Speaker Change: This does seminal one.
Speaker Change: I work with that have you seen specifically activity in PD lone positive patients just wondering if I know there have been actually sits in the platinum resistant setting, but I'm. Just wondering if you had seen that and maybe you could make some read through into what the.
Speaker Change: Combinability would look like and given that you might get some PD one approved in this setting and the late.
Speaker Change: Turning to secondly, PD, one VEGF vis vis vis a lot of interest at these days.
Asthika Goonewardene: Secondly, PD-L1 VEGF, I suppose there is a lot of interest these days. I have a multi-part question for you on that, if I may. One, have you looked at what adding VEGF does to TGPlus PD-L1? And can you talk about any synergies that you've observed? Does the FC inactive strategy make sense here, too? And have you discussed any of this data with your partners at AZ? Thank you.
The multi part question for you on gas.
Speaker Change: Alright.
Speaker Change: Have you looked at what adding that Jeff does strategic plus PD one.
Speaker Change: And can.
Speaker Change: Can you talk about any synergies that you've observed does the F. C inactive strategy makes sense you too.
Speaker Change: And have you discussed to get this data with your partners.
Speaker Change: Thank you.
Michelle Mahler: So, I will take some of your questions and then defer to Eran for further input. So, to start with the question about activity in patients that are PD-L1, whether they are positive or negative. So, in our platinum-resistant data, we have presented in the past that we see activity both in PD-L1 positive and negative patients, and it's one of the reasons why we believe that when we use COM-701, it tends to be a PBRG-mediated activity because traditionally single-agent PD-L1 inhibition in platinum-resistant patients has not been very effective.
Speaker Change: So I will take some of your question and then deferred to Iran. Full further input so to start with the question about activity in patients that are PD L. One whether they're positive or negative so in our.
Speaker Change: Platinum resistant data, we have presented in the past that we see activity both in PDL, one positive and negative patients.
Speaker Change: And it's one of the reasons why we believe that when we use comes 701 it tends to be a P. B R. G mediated activity because traditionally single agent PD one inhibition in platinum resistant patients has not been very effective as far as the PD, one veg F I'm Gonna have Iran comment.
Eran Ophir: As far as the PD-L1 VEGF, I'm going to have Eran comment. Yeah, thank you, Michelle, and thank you, Asthika, for the question. So just to add a bit about the PD-L1, so what is really interesting and what we have shown quite extensively that PVRG biology is very different from PD-L1, from TIGIT, and other checkpoints. And that is the reason why we think that we see this unique activity in places where checkpoints are typically not working, including in PD-L1-negative patients. We even have a monotherapy activity of COM-7-1 alone in a patient with a PD-L1-negative tumor microenvironment.
Speaker Change: <unk>.
Thank you Michelle and thank you Oscar for the question. So just to add a bit about the PD. One so what is really interesting and what we have shown quite extensively that people at your biology is very different for PD, one from teachers and other checkpoints and that is the reason why we think that we see this unique activity in places where checkpoints are typically not working.
Speaker Change: Clothing, and PDL, one negative patients who had been up a monotherapy activity of consumer non alone in a patient with a PDL one negative but to a macro environments. So definitely we think that this would explain why you could be active and now when we have some signal of activity.
Eran Ophir: So definitely we think that this will explain why PVRG could be active.
Eran Ophir: And now when we have some signal of activity of a PD-L1 blockade in the last line in combination with chemo, we definitely think that it could be that when COM-7-1 would be added, potentially also to PD-L1, we can now treat also patients with PD-L1-negative that would not respond properly to go to PD-L1 alone. About the PD-L1 VEGF, so VEGF in general has a mechanism in addition to the anti-angiogenic effect to increase this infiltration. So mechanistically, point of view, this could definitely, it goes along with the biology of PVRG blockade that increase this infiltration with other mechanisms. We didn't publish any data on this regard, but we definitely could be a mechanism that would complement specifically PVRG biology in addition to the other activities it is doing with any other checkpoints.
Speaker Change: PD one blockade in the last line with combination with chemo, we definitely think that it could be that when it comes to than one would it be at the potential also to PD. One we can now treat also patient with triple negative that would not respond to probably go to PD one alone about the PD one VEGF. So.
Speaker Change: But just in general it has a mechanism in addition to the until the identical effect to increase T cell infiltration. So mechanistically point of view this could definitely it goes along with the village of bigger a duplicate that increase T cell infiltration with other mechanism. We didn't publish any data on this will go but we definitely could.
Speaker Change: Be a mechanism that would complement specifically <unk>. In addition to the other activities is doing with any other checkpoints and I don't think specifically the active or not active will master mechanistically.
Eran Ophir: And I don't think specifically the FC-active or non-active will matter mechanistically. But since the FC active have, again, some safety challenges, and since it's yet to be seen if the PD-1 VEGF by specific indeed really solves the BEV side effects. So the combination of what could be still some toxic agent like PD-1 VEGF with another a bit toxic agent like FC active digits could be challenging.
Speaker Change: But since the F C active have again some safety challenges.
Speaker Change: Since it's yet to be seen if the PD one view just by specific indeed really solves the.
Speaker Change: The Bev.
Speaker Change: Side effects. So the combination of what could be still some toxic agent like they do on vgs within.
Speaker Change: Another a bit toxic agent like uptick digits could be challenging. So we think that soon as well it would prefer them to combine.
Eran Ophir: So I think that here as well, it will be preferable to combine any kind of this agent, including PD-1 VEGF with an FC non-active digit.
Speaker Change: Any kind of these agents, including one PD, one VEGF with an FC known active digits.
Unknown Executive: This concludes the Q&A session and Compugen's investor conference call. Thank you for your participation. You may go ahead and disconnect.
Speaker Change: This concludes the Q&A session and coffee Jones Investor Conference call. Thank you for your participation you May go ahead and disconnect.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: [music].
Unknown Executive: Thanks for watching!
Speaker Change: Okay.
Speaker Change: [music].