Q1 2024 Compugen Ltd Earnings Call
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Operator: Ladies and gentlemen, thank you for joining us today. Welcome to Compugen's first quarter 2024 results conference call. At this time, all participants are in a listen-only mode. An audio webcast of this call is available in the investor section of Compugen's website, www.cgen.com. As a reminder, today's call is being recorded. I would now like to introduce Yvonne Naughton, Head of Investor Relations and Corporate Communications. Yvonne, please go ahead.
Speaker Change: Ladies and gentlemen, thank you for joining us today welcome to <unk> first quarter 2024 hours.
Speaker Change: <unk> conference call at this time, all participants are in a listen only mode on the audio webcast of this call is available in the investors section of <unk> website, Www Dot <unk> Dot com as a reminder, today's call is being recorded I would now like to introduce Yvonne Naughton head.
Yvonne Naughton: [noise] of Investor Relations and corporate Communications you bought please go ahead.
Yvonne Naughton: Thank you, Operator, and thank you all for joining us on the call today. Joining me from Compugen for the prepared remarks are Dr. Anat Cohen Dayag, President and Chief Executive Officer, and Alberto Sessa, Chief Financial Officer. Dr. Michel Malheur, Chief Medical Officer, and Dr. Eran Ophir, Chief Scientific Officer, will join us for the Q&A.
Yvonne Naughton: Thank you operator, and thank you all for joining us on the call today, joining me for <unk> for the prepared remarks, our doctor not Colin Dyer, President and Chief Executive Officer, and Alberto Sessa, Chief Financial Officer, After Michelle mother, Chief Medical Officer, and Dr. Iran Nuclear 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, the business outlook, development efforts and their potential outcome, the company's discovery platform, anticipated progress and plans, results and timelines for our programs, financial and accounting-related matters, as well as statements regarding our cash position. 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.
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 development efforts and the potential outcome. The company's discovery platform anticipated progress on planned results and time lines for our programs financial and accounting related matters as long as statements regarding our cash position.
Yvonne Naughton: These statements are subject to known and unknown risks and uncertainties, and we refer you to the SEC filings for more details on these risks, including the company's most recent annual report on Form 20F. The company undertakes no obligation to update projections and forward-looking statements in the future.
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 the SEC filings for more details on these risks, including the company's most recent annual report on.
Yvonne Naughton: Form 20-F.
Yvonne Naughton: The company undertakes no obligation to update projections and forward looking statements in the future.
Speaker Change: With that I'll now turn the call over to announce.
Anat Cohen: Thank you, Yvonne, and thank you, everyone, for joining us on our first quarterly 2024 call. Today, I will cover the significant progress we have made across our pipeline in the first quarter of this year, and I will then move to our planned catalyst through the rest of 2024. But before I go there, I thought I would start on a question which we frequently get asked.
Speaker Change: Thank you Yvonne.
Speaker Change: Thank you everyone for joining us on our first quarter 'twenty one forecast.
Speaker Change: Today I will cover the significant progress we have made across our pipeline in the first quarter update here and I will then move to our plans carefully through the rest of 2024.
Speaker Change: But before I go there I felt I would start on a question we frequently get asked.
Anat Cohen: Is Compugen an AI company? And the answer is yes. Compugen is a pioneer in computational discovery of novel drug targets, and not just in theory, but in practice, which is a significant differentiator. We successfully moved our newly discovered drug target from computer prediction to drug discovery to preclinical and clinical trials, continuously feeding our own pipeline with potential significant opportunities to address cancer immunotherapy resistance. The Gilead deal on COM503 highlights the most recent asset discovered through our computational discovery capability. Our Discovery Platform is a validated AI-powered platform.
Speaker Change: It can be again, an AI company and the answer is yes.
Speaker Change: <unk> is a pioneer in computational discovery of novel drug targets and not just in theory, but in practice, which is a significant differentiator.
Speaker Change: We successfully moved our newly discovered drug target from computer prediction to drug discovery through preclinical and clinical trials continuously seeking to our own pipeline with potential significant opportunity to address cancer immunotherapy resistance.
Speaker Change: The Gilead deal on call. So first three highlights the most recent aspen discovered through our computational discovery capabilities.
Speaker Change: Our discovery platform. He just validated AI and then power tax law.
Anat Cohen: This platform is the engine fueling our competitive advantage and pipeline and has already delivered multiple fully-owned clinical programs, multiple validating strategic partnerships, and multiple early-stage undisclosed assets, which are expected to feed our future pipeline and the opportunity to deliver long-term value creation. We plan to speak more about our Discovery Platform at future events, so now I will move to the focus of today's call. In the first quarter of the year, we again delivered on our promise.
Speaker Change: This platform is the engine fueling our competitive advantage in pipeline and has it already the labor.
I think that it's fully owned clinical programs multiple is validating strategic partnerships and multiple early stage undisclosed assets, which are expected to feed our future pipeline and the opportunity to deliver long term value creation.
Speaker Change: We plan to speak more on our discovery platform at future events. So now I will move to the focus of today's call.
Speaker Change: In the first cohort of the year, we again executed on our promises.
Anat Cohen: Firstly, at the annual ASCO conference in June, we will present preliminary anti-tumor activity of COM701 in combination with COM902 and Pembroli Dumab in patients with MSF-CFD and liver metastasis from our ongoing proof-of-concept study. Secondly, we completed enrollment of more than 20 patients in our platinum-resistant ovarian cancer study, and we're on track to report initial findings in Thirdly, the progress we have made unlocking the novel biology of new drug targets and in diversifying our approach to address cancer immunotherapy resistance was reflected in our presentations at the Ketone Symposium and the American Association of Cancer Research Conference in March and April this year, along with the publication of our COM503 and PVRG papers in cancer immunology research.
Speaker Change: Firstly at the annual <unk> Conference in June.
Speaker Change: Present preliminary antitumor activity of concept in a one in combination with continental tool and.
Speaker Change: Temporarily to lob in patients with MSS, CRC and lever them, it's tough to say from our ongoing proof of concept study.
Speaker Change: Secondly, we completed enrollment of more than 20 patients in platinum resistant ovarian cancer study and we're on track to report initial findings in the fourth quarter of this year.
Speaker Change: Thirdly, the progress we have made unlocking novel biology of new drug target.
Speaker Change: And in diversifying our approach to address cancer immunotherapy resistance was reflected by our presentation at the Keystone Symposium and the American Association of Cancer Research Conference in March and April each year, and along with the publication of our.
Speaker Change: Comm cycle, three and PV energy papers in cancer Immunology research.
Anat Cohen: At both conferences, we presented data supporting the unique biology of PVRIG, suggesting its role in sensitizing tumors to the other immune checkpoints, TG10PV1, and additionally, data supporting the therapeutic potential of our high-affinity, potential first-in-class anti-RLA-10 binding protein antibody, CONFYL-43, showing its activity is localized to the tumor macro environment with the potential advantage of a wider therapeutic window than systemically Finally, in the first quarter of 2024, our partner AstraZeneca continued to rapidly advance the development of ribvagostomy, and we are delighted that they are initiating a second phase 3 trial, tropion lung 10, in non-squamous non-small cell cancer.
Speaker Change: It's both conferences, we presented data supporting the unique biology of P. B R. A G SIB.
Troy: Thank you Troy and sensitizing tumors to the other immune checkpoints TJ can PD, one and additionally data supporting that that puts us potential of our high affinity potential first in class anti IL 18 binding proteins antibodies conflict free.
Knowing its activities localized to the tumor microenvironment with the potential advantage of the wider therapeutic window than systemically delivered cybercrime.
Troy: Finally in the first quarter of 2020 for our partner Astrazeneca continue to rapidly advance the development of friends Augusta Me.
Speaker Change: We're delighted that they are initiating a second phase III trial Trump you, who runs 10 in non squamous non small cell lung cancer.
Anat Cohen: The study will assess GAST-Omeg as monotherapy and in combination with DATO-DXD, a TROP2-directed ADC being developed in collaboration with Deichi Sankyo, compared to pembrolizumab as first-line treatment for patients with advanced or metastatic non-squamous lung cancer with high PD-L1 expression. As a reminder, we recently received a $10 million milestone payment upon dos Under this agreement, we are eligible to receive development milestone payments for the first and second indications.
Speaker Change: This study will assess where the gusto Mig as monotherapy and in combination we'd definitely be XD. It dropped to a directed ADC being developed in collaboration with Daiichi Sankyo Com.
Speaker Change: Compared to temporary labor laws as first line treatment for patients with advanced or metastatic non squamous lung cancer with high PDL one expression.
Speaker Change: As a reminder, we recently received a $10 million milestone payment upon dosing of the first patient in the phase III study off the first indication biliary tract cancer.
Speaker Change: Under this agreement we're eligible to receive development milestone payments for the first and second indication.
Anat Cohen: The progress into a second phase three trial addressing a major indication, such as non-squamous non-small cell cancer, reinforces our partnering strategy to broaden opportunities for our pipeline and brings us closer to realizing additional future milestone payments and royalties. As a reminder, the TGIC component of Rilvagastimig is derived from our potential best-in-class anti-TGIC COM902, and both Rilvaga Moving on now to what's planned for the rest of the year.
Speaker Change: The progress into a second phase III trials addressing a major indications such as non squamous non small cell lung cancer.
Speaker Change: Reinforces our partnering strategy to broaden opportunities for our pipeline.
Speaker Change: And brings us closer to realizing additional future milestone payments and royalties.
Speaker Change: As a reminder, the teacher component of the Gods to league is derived from our potential best in class anti Tejas comment or two.
Speaker Change: And both with regards to Megan Continental tool.
Speaker Change: In the extra reduced Ines dysfunction Kent.
Speaker Change: Moving on now to work planned for the rest of the year.
Anat Cohen: 2024 is planned to be a catalyst-rich year for us with multiple data readouts and updates expected from our diversified portfolio. At ASCO in June, we plan to present data from our ongoing proof-of-concept study in MSSCRC patients, including those with liver metastasis, who have been treated with the triple-IO combination of COM-701 and COM-902N pembrolizumab. MSSERC, and in particular, such patients with liver metastasis, represent significant unmet medical needs in the hard-to-treat patient population. Exited in 2022, we presented data from our first cohort of 22 patients, treated with a dual combination of Comter and Huanany volume up, and who were the first and only company to report responses to I.O.
Speaker Change: 'twenty 'twenty four is planned to be a catalyst rich year for us with multiple data readouts and updates expected from our diversified portfolio.
Speaker Change: It's actually in June we plan to present data from our ongoing proof of concept study in MSS CRC patients, including those with liver metastases, who have been treated with a triple I O combination of call seven or one comment at length embodies a lot.
Anat Cohen: in this population of patients with liver metastasis, reporting a 12% overall response rate and stable disease, in addition to immune activation supporting pvrg biology and COM701 mechanism of action. Although this indication was not initially selected based on dominant PPRRG pathway expression levels, following this encouraging clinical data and with an aim to assess the strength of our findings in liver metastasis patients in a larger cohort, we initiated our ongoing study in 20 patients with MSS series and added our anti-TGCOM902 to the drug combination to see if we could improve on the response seen with a dual combination. The response was rapid, reflecting the significant unmet need, and we enrolled the last patient in September.
Speaker Change: And if the CRC and in particular, such patients with liver metastasis represents significant unmet medical need and in hard to treat patient population.
Speaker Change: It's sitting in 2022 we presented data from our first cohort of 22 patients treated with the drug combination of college doesn't want any volume up.
Speaker Change: And who were the first and only company.
Speaker Change: So report responses to I O in this population of patients with liver metastasis.
Speaker Change: 14th at 1% overall response rate and stable disease.
Speaker Change: In addition to immune activation supporting Piggy argue biology and concept and the one mechanism of action.
Speaker Change: Although this indication was not initially selected based on dominant T V. R. G pathway expression levels.
Following this encouraging clinical data and we didn't aim to assess the strength of our findings in liver metastasis patient in a larger cohort we initiated our ongoing study in 20 patients with MSS CRC and ended our anti ticket continental's too to the drug.
Speaker Change: Combination to see if we could improve on their responses seen with the drug combination.
Recorded was rapid reflecting the significant unmet need and we enrolled the last patient in September 23.
Anat Cohen: The data will be presented at the upcoming ASCO on June 1st with a data cut-off date of April 5th, 2024, and remains supportive of COM71-mediated activity and safety, with some patients continuing treatment as the data cut-off date. However, with the totality of the data we have in hand, we believe that an IO-IO approach is not the way forward in this notoriously IO-resistant patient population of MS3- Yet another example:
Speaker Change: The data will be presented at the upcoming US call on June 1st we the data cutoff date.
Speaker Change: <unk> 24.
Speaker Change: Remain supportive of called seven one megawatts at the activity and safety.
Speaker Change: Some patients continuing treatment is the data cutoff date.
Speaker Change: However, with the totality of the data we have in hand, we believe than an Io Io approach is not the way forward. Indeed notoriously I always they send a patient population of fantasy series C with liver metastases.
Speaker Change: Yes.
Anat Cohen: The total clinical activity observed to date in the two evaluated cohorts suggests the effects are COM701-mediated and, due to the unique biology of PVR-IG, may warrant further evaluation of COM701 with other agents in the MSS series. Therefore, the door remains open for other COM-71 combinations in this patient population. However, this will not be the focus of our internal resources at this time.
Speaker Change: The total clinical activity observed to date in the trial evaluated cohorts suggest the effect our concept of one mandated and due to the unique biology of P. D. R. I G may warrant further evaluation of.
Speaker Change: <unk> 701 with other.
Speaker Change: Other agents in MSS CRC.
Speaker Change: Therefore, the door remains open for other combinations in this patient population.
Speaker Change: However, this would not be the focus of our internal resources at this time.
Anat Cohen: It is important to know that observations made in tumors which are biologically distinct from each other, such as MSSCRC and platinum-resistant ovarian cancer, are not considered indicative of each other. With this in mind, I will remind you that we have reported more dominant PVRIG pathway expression levels in ovarian cancer. This brings us to our next cut.
Speaker Change: It is important to note that observation, making sure we drive biologically distinct from each other such as Ana said CRC in platinum resistant ovarian cancer.
Speaker Change: I'm not considered indicative of each other.
Speaker Change: With this I want to remind you that we have reported more domino's pizza argued pathway expression levels in ovarian cancer.
Speaker Change: This brings us to our next catalyst.
Anat Cohen: The next catalyst for our triple combination will be the presentation of our data in platinum-resistant ovarian cancer, for which we have completed enrollment. Data presentation is on track for the fourth quarter of 2024, and our plan is to present this data at a medical conference. We believe the totality of the data we have reported to date in platinum-resistant ovarian cancer patients is encouraging compared to the current standard of care. Based on the data we reported at SMIO in December 2022 from the first cohort of 20 platinum-resistant ovarian cancer patients treated with triple combination.
Speaker Change: The next catalyst for a triple combination will be the presentation of our data in platinum resistant ovarian cancer for which we have completed enrollment.
Speaker Change: Data presentation is on track for the fourth quarter of 2024, and our plan is to present this data at a medical conference.
Speaker Change: We believe the totality of the data we have reported to date in platinum resistant ovarian cancer patients.
Encouraging compared to the current standard of care.
Speaker Change: Based on the data we reported at ESMO I O. In December 2022 from the first cohort of 20 platinum resistant ovarian cancer patients treated with triple combination.
Anat Cohen: Investigators were excited to report durable shrinking or stabilization of tumors in some of their patients who had previously progressed on all available treatment options. We presented a 20% overall response rate, with some patients responding for over 16 months, which is favorable, considering the median duration of response for single-agent chemotherapy is around three to four months, and for ADC, is around 6.9 months. Responses were achieved in hard-to-treat high-grade serous adenocarcinoma patients, along with a favorable safety profile.
Speaker Change: Investigators were excited to report Durbin shrinking or something they station of tumors in some of their patients who had previously progressed on all available treatment options.
Speaker Change: We presented a 20% overall response rate with some patients responding for older 16 months.
Speaker Change: Which is forever, but considering median duration of response for single agent chemotherapy is around three to four months.
Speaker Change: D C is around six nine months.
Responses were achieved in the half to treat high grade serous dental guards in all the patients.
Speaker Change: And along with the favorable safety profile.
Anat Cohen: We also presented preliminary biomarker data showing an association between PVRN2 expression and clinical benefits. Of note, we also previously presented data showing COM-701 monotherapy activity in a patient with ovarian cancer whose tumor microenvironment was an immune desert. This patient had a partial response of more than 18 months. For the ongoing study, we plan to present data in the fourth quarter of the year, including the baseline characteristics, safety, overall response rate, disease control rate, preliminary data on duration of responses, and potentially biomarker data. Data showing clinical benefit in platinum-resistant ovarian cancer is expected to allow us to pursue the next studies towards a path to registration, which, depending on data, may employ a predictive biomarker enrichment structure.
Speaker Change: We also presented preliminary biomarker data showing an association between T V already two expression and clinical benefit.
Speaker Change: Of note. We also previously presented data showing comps have been a lot of mono therapies TVT.
Speaker Change: In a patient with ovarian cancer, whose tumor microenvironment was immune desert.
Speaker Change: This patient had a partial response of more than 18 months.
Speaker Change: So the ongoing study we plan to present data in the fourth quarter of the year, including the based on characteristics safety overall response rate disease control rate preliminary data on duration of responses and potentially biomarker data.
Speaker Change: That is showing clinical benefit in platinum resistant ovarian cancer is expected to allow us to pursue the next study toward a path to registration, which depending on data mean purely a predictive biomarker enrichment strategy.
Anat Cohen: In addition, we're also on track to submit the IND for COM503 in the second half of this year and expect that IND clearance, for which we're eligible for 30 million dollars in maximum payments from Gilead, will be achieved in 2024. With that expectation, we're in the advanced stages of planning the Phase I study. Finally, in the second half of this year, AstraZeneca expects data from their Phase I-II Artemide I trial in non-small cell cancer in the front-line set.
Speaker Change: In addition, we're also on track to submit the I N D. So called FIFO suite in the second half of this year.
Speaker Change: We expect the time be clearance for which we're eligible for $30 million in milestone payments from Gilead will be achieved in 'twenty 'twenty four.
Speaker Change: We did expectation we're in advanced stages of planning the phase one study.
Speaker Change: Finally in the second half of this here Astrazeneca expects data from their phase one to optimize one trial in non small cell lung cancer in the frontline setting.
Anat Cohen: Before passing over to Alberto to go through the financials, I would like to take this opportunity to warmly thank him for his commitment and leadership since he joined us in 2020. Alberto has been a great partner to me and the rest of the team here at Compugen. David Silverman will take over the reins from Alberto as Chief Financial Officer effective August 15. David has experience in the healthcare industry as chief financial officer of a biotech company traded on the NASDAQ, and I'm looking forward to introducing you to David when he joins us.
Speaker Change: Before passing over it was better to go through the financials.
Speaker Change: I'd like to take this opportunity to warmly thank him for his commitment and leadership since he joined us in 2020 two.
Speaker Change: Alberta has been a great partner to me and the rest of the team here is concrete yet.
Speaker Change: David Silverman will take over the reins from Alberto as Chief Financial Officer effective August 15th.
Speaker Change: David has experience in the health care industry as Chief Financial Officer for biotech company traded on the NASDAQ and I'm looking forward to introducing you to David when he joins.
Anat Cohen: I also want to emphasize that while benefiting from our solid cash position to enhance and advance Compugen to additional milestones, we're also financially disciplined. We have two potential first or best-in-class unrestricted assets, along with multiple undisclosed early-stage assets, with the possibility to address a significant unmet need in immuno-oncology. In addition, we have two strong strategic pharma partners, Gilead and AstraZeneca, on Rilvigasumig and CONF503, respectively, from whom we are eligible to receive future milestone and royalty payments. With that, I will hand over to Alberto for the financial update.
Speaker Change: I also want to emphasize this was benefiting from our solid cash position to enhance an advance copy done two additional milestones will also financially disciplined.
Speaker Change: We have two potential first or best in class unrestricted assets and loan with multiple undisclosed early stage assets with the possibility to address a significant unmet need in immuno oncology.
Speaker Change: In addition, we have two strong validating strategic pharma partners get it and Astrazeneca on really begun to make in car types were three respectively and from whom we're eligible to receive future milestone and royalty payments.
Speaker Change: With that I will hand over to Alberto for the financial update.
Alberto Sessa: Thank you Ron.
Alberto Sessa: I'm happy to summarize our financial results. I will start with our cash balance. As of March 31st, 2024, we had approximately $101.3 million in cash compared with approximately $51.1 million as of December 31st, 2021. This cash balance includes $60 million from payment from Gilead related to the licensing of COM503, and $10 million milestone payment from AstraZeneca on dosing the first patient in the Phase III trial in biliary cancer. We recognize the importance of cash efficiency, and we are disciplined in how we deploy our cash reserves while making sure we focus on reaching K-Minds.
Alberto Sessa: To summarize our financial results.
Alberto Sessa: We have a cash runaway into 2027, taking into account the expected milestone payment of $30 million from Gilead for COM503 IND clearance expected in the second half of 2024. It is important to emphasize that this does not include any additional potential cash inflow from our partners. I remind you that the company has no debt. Revenue for Q1 2024 was approximately $2.6 million compared to no revenue for the comparable period in 2022.
Alberto Sessa: I will start with our cash balance.
Alberto Sessa: March 31st 2024, we had approximately $101.3 million in cash.
Alberto Sessa: Third with approximately $51 $1 million as of December 31st 2023.
Alberto Sessa: This cash balance includes $60 million upfront payment from Gilead related to the licensee of qualified victory and $10 million milestone payment from Astrazeneca on dosing the first patient in the phase III trial in biliary tract cancer.
Alberto Sessa: We recognize the importance of cash efficiency and we are disciplined in how we deploy our cash for years.
Alberto Sessa: While making sure we focus on reaching key milestones.
Alberto Sessa: With a customer or a weak into 2027, taking into account the expected milestones payments of $30 million from Gilead.
Alberto Sessa: 503.
Alberto Sessa: The clearance expected in the second half of 2024.
Alberto Sessa: It is important to emphasize that this does not include any additional potential cash inflow from our sponsors.
Alberto Sessa: I'll remind you that the company has no debt.
Alberto Sessa: The revenue reflects recognition of a portion of the upfront payment from the license agreement with Gilead. Expenses for the first quarter of 2024 were in line with our plan. R&D expenses for the first quarter of 2024 were $6.4 million, down from $7.4 million in the first quarter of 2022. Our G&A expenses for the first quarter of 2024 were $2.4 million, compared to $2.6 million in the first quarter of 2022. For the first quarter of 2024, the net loss was $7.3 million or $0.08 per basic and diluted share compared to a net loss of $9.3 million or $0.11 per basic and diluted share in the first quarter of 2023. With that, I will hand it back to Anat to summarize. Thank you, Alberto.
Alberto Sessa: Revenue for Q1, 2024 were approximately $2 $6 million compared to no revenue for the comparable period in 2023.
Alberto Sessa: Revenue reflects recognition of a portion of the upfront payment from the license agreement with Gilead.
Alberto Sessa: Expenses for the first quarter of 2024 were in line with our plans.
Alberto Sessa: R&D expenses for the first quarter of 2024 were $6 $4 million reduced from seven $4 million in the first quarter of 2023.
Alberto Sessa: Our G&A expenses for the first quarter of 2024 were $2 $4 million compared to $2 $6 million in the first quarter of 2023.
For the first quarter of 2024, net loss was $7 $3 million or eight cents per basic and diluted share compared to a net loss of $9 $3 million or <unk> 11 per basic and diluted share in the first quarter 'twenty to 'twenty three with that.
Speaker Change: I will hand back to summarize.
Speaker Change: To summarize.
Speaker Change: Thank you Alberto.
Anat Cohen: To summarize, Compugen stands out as a clinical stage immune oncology target discovery pioneer. We're differentiated by our validated discovery platform, which is powered by the mix of human expertise with AI and machine learning to fuel our first-in-class pipeline. We're on track to deliver a catalyst-rich 2024 across our diversified pipeline and planning to present data for our COM-71, COM-902 triple combinations at ASCO and MSF-CRC, as well as data from our platinum-resistant ovarian cancer at the end of the year.
Speaker Change: To summarize comprehend stands out as a clinical stage immune oncology target discovery pioneer we're differentiated by our validated discovery platform, which is powered by the mix of human expertise with AI and machine learning to fuel our first in class.
Speaker Change: Thanks.
Speaker Change: We're on track to deliver a catalyst rich 'twenty 'twenty four across our diversified pipeline and planning to present data for our content and one continental to triple combination it outgoing MSS CRC.
Speaker Change: Data from our platinum resistant ovarian cancer at the end of the year.
Anat Cohen: We're planning to submit Comp 503 for IND in the second half of this year and are advancing our planning for the initiation of phase one for this program. With a pipeline that is being advanced internally and by our partners, this is an exciting time for Compugen. And we believe that we have the fundamentals in place to bring value to our shareholders and cancer patients. I am proud of what we are accomplishing here at Compugen.
Speaker Change: We're planning to submit to qualify for a three or four <unk> in the second half of this year and advanced in our planning for the initiation of phase one for this program.
Speaker Change: We just pipeline that is being advanced in Tennessee.
Speaker Change: And by our partners. This is an exciting time for coffee again, and we believe that we have the fundamentals in place to win value to our shareholders in cancer patients.
Jan: I'm proud of what we're achieving here it's coffee Jan.
Anat Cohen: I would like to thank all our Compugen colleagues for their collaborative spirit and daily dedication, resulting in a well-executed first quarter of the year and setting us up for future success. With that, I will turn the call over to questions. Operator.
Speaker Change: I would like to thank all our competition colleagues for their collaborative spirit and daily dedication, resulting in a well executed first quarter of the year and setting us up for future success with that I will turn the call over for questions operator.
Jan: Okay.
Speaker Change: Thank you.
Operator: 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 speaking. If you are using speaker equipment, kindly lift the handset before pressing the numbers.
Speaker Change: 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 our polling process. Please press star two.
Speaker Change: Pure speak.
Speaker Change: If you are using speaker equipment in Congo, with the handset before pressing the numbers. Please standby, while we poll for your questions.
Operator: Please stand by while we poll for your question. The first question is from Stephen Wiley of Stiefel. Please go ahead.
Speaker Change: The first question is from.
Speaker Change: Stephen Wiley of Stifel. Please go ahead.
Speaker Change: Yeah.
Toveon: Hi guys, this is Toveon for Steve. Thank you for taking my question and congratulations on the progress. We just have two questions on our end. The first one is related to colorectal trials. So, I know that ASCO abstracts will be available this week, but when it comes to the actual presentation, how much additional incremental detail should we expect in the actual presentation versus the abstracts? And following this presentation, what would be a path forward for this study? And the second question would be related to ComPyWall3. Do you think you will disclose any clinical data following IND submission for these aspects? And so, maybe, thank you.
Toby: Hi, guys. This is Toby on for Steve. Thank you for taking my question and congrats on the progress.
Speaker Change: We just have two questions on our end the first one is where they could go colorectal trials. So I don't know Oscar I starts it will be available this week, but when it comes to the actual frequency isn't how much additional incremental detail should we expect in the actual presentation versus.
Toby: Abstract.
Speaker Change: All told we're in good position to award would be a path forward for this study and the second question would be related to come probably will see do you think you will disclose any pre clinical data of Halloween I. Indeed mission all towards exactly thank you.
Anat Cohen: And so, thank you, and maybe I'll start with the second question for COM 543. This decision to disclose clinical data from a Phase I study will be taken in collaboration with Gilead. This is an asset that was licensed to Gilead, and I cannot commit on their behalf, and we'll give some guidance when we know. But obviously, before that, we'll need to file the IND and initiate the study, which filing is expected in the second half of this year. And for the CRC data, yes, the abstract is going to be out this week, and the presentation of data will be June 1st for Compugen. It will be data worth 20 patients enrolled.
Speaker Change: And so maybe thank you and maybe I'll start with your second question for complex for free.
Speaker Change: This decision off disclosing clinical data from our phase one study.
Speaker Change: Would it be taken in collaboration with Gilead dishes and often that's what's licensed to Gilead.
Speaker Change: And I cannot commit on their behalf and we'll give some guidance when we know.
Speaker Change: But obviously for a desk with me two five D. I N V and initiate the study.
Speaker Change: Hey, rich filing is expected in the second half of this year.
Speaker Change: And for the CRC data yesterday abstract who's going to be out here. This week.
Speaker Change: And the presentation of data will be in June 1st for coffee Jan It would it be a data warehouse 20 patients enrolled and we sure are the antitumor T. G durability translational data safety a chance right obviously.
Anat Cohen: And we share the anti-tumor activity, durability, translational data, safety, et cetera, and obviously patient baseline characteristics. And as we've already stated, the data is supportive of the anti-tumor activity of COM701, and it is supportive of COM701's mechanism of action, PVRIG biology. But we believe, based on the data, and this is the guidance that we shared today; it was important for us to share the guidance at the time that we know what the decision that we've already taken is that we believe that IO-IO only combinations would not be the right way to target MSSCRC with the liver mass population, which, as you know, in this line consists of 70% of the patient population.
Speaker Change: And patient baseline characteristics.
Speaker Change: And as we as we've already stated the data is supportive of vantage and works feature of constant on a one you're supportive of constant and one mechanism of faction P. P. M D biology, and we believe based on the data and do you see the guidance that we shared today was important for us to share in the <unk>.
Speaker Change: And I said at the time that we know what the decisions that we've already took you start to believe that I O I O only combinations would not be derived way to target MSS CRC, we'd lever mass population, which as you know in this line consists of some 70% of the patient population.
Anat Cohen: We believe that that's not the right path, and we decide that while there could be a path forward for COM701 in MSSCRC with liver mass, maybe in other combinations, or maybe even in earlier lines, we're not taking this path forward at this point in time.
Speaker Change: <unk>, we believe that that's not the right path and do we decide that why there could be a path forward for constant or a new one.
NSS CRC, we'd lever Max maybe in other combinations or maybe even in earlier line, we're not taking dispatch for at this point in time.
Speaker Change: Yeah.
Speaker Change: Thank you.
Speaker Change: Thank you.
Operator: The next question is from Asthika Goonewardene of Truist Securities. Please go ahead.
Speaker Change: The next question is from a FICO good warden of Truest Securities. Please go ahead.
Speaker Change: Yeah.
Asthika Sarith Goonewardene: Hi guys, good morning, and thanks for taking my question.
Speaker Change: Hi, guys. Good morning, and thanks for taking my question so.
Anat Cohen: So, maybe we want to just dig in a little bit more here on colorectal, and I'd like for maybe you and Eran to comment on what you think is missing here. It sounds like you're resilient that 701 biology is active, but maybe if you can help us understand what you need more immune activation and less, maybe less checkpoint blockade, but maybe more debulking. I mean, what exactly is the missing link here, given the encouraging activity we saw earlier for this approach?
Speaker Change: And then wanted to just digging a little bit more share on colorectal and anal.
Speaker Change: Maybe you and neuron to comment on what do you think is missing here it sounds like Youre a resilient several one biology that here, but maybe if you can help us understand.
Speaker Change: What did you need more immune activation and less maybe less checkpoint blockade, but maybe more de bulking what exactly was.
Speaker Change: What is the missing a wheelchair given.
Given the.
Speaker Change: The encouraging activity we saw earlier.
Speaker Change: So this approach and then beyond ovarian for sort of one or two how should we think about the other avenues that you're going to pursue this combination.
Anat Cohen: And then, beyond ovarian cancer for 701, 902, how should we think about the other avenues that you're going to pursue this combination? Is there a next priority to maybe revive efforts in CRC, but with a different combination to maybe address what's missing? Or have you identified another tumor type that you would like to take this into? Thanks.
Speaker Change: Is there is your next priority to maybe revise efforts in CRC, but with a different.
A combination to maybe address what's missing or.
Speaker Change: Have you identified another tumor type.
Speaker Change: That that you would like to take the symptoms.
Eran Ophir: Okay, thanks Asthika. I'll start by saying that, look, we can't really get to the specifics of the data, and maybe this discussion will be worth having following the presentation on June 1st. Maybe Eran wants to add, but I'll just say that with IO only... We believe that what we see is not enough in order to pursue it. But maybe, Eran, do you want to say anything about it more than that? Yeah, so.
Speaker Change: Okay. Thanks.
Speaker Change: And I'll start by saying that look we can get really to the specifics of the data and maybe this discussion will be worth to be taken following that presentation in June 1st.
Speaker Change: Maybe around wants to add but I'd, just say that we I know only.
Speaker Change: We believe that and then what we see is not enough in order to pursue but maybe around you want to say anything about it more than that yes.
Eran Ophir: Yeah, so with the unique biology of PVRG and what we have seen previously, definitely, we see activity in places where normally checkpoints are not working in MSSCRC. We live in metastasis, immune modulation, increasing T cells, but we've seen it in part in the patients, right? And eventually, to move forward, you need to have sufficient activity in sufficient numbers of patients to really consider going towards approval. And as you understand, with what we see in the pure IO combination of the triplet in this very difficult and not immunogenic indication, what we have seen is not enough to convince ourselves to move forward as is.
Speaker Change: Yeah. So.
Speaker Change: These people again, what you have seen previously definitely we see activity in places where normally checkpoints on both working and I'm, a sister C with liver metastases immune modulation intrusive T cells, but we've seen it in part of the patients' rights and eventually to do forward you need to have sufficient activity in sufficient amount of the patients to really consider to go towards approval.
Speaker Change: And as you understand with what we've seen a few io combination or the triplet in this spirit difficult and not immunogenic indication.
Speaker Change: What you've seen is not enough to convince ourselves to move forward as is and this is discussed maybe not at this point in time, but there are other rational based combination that could be employed to increase activity. In this kind of difficult indication that there is something to consider for the future, but again not at this point in time.
Eran Ophir: And yes, as discussed, maybe not at this point in time, but there are other rational combinations that could be employed to increase IO activity in this kind of difficult indication, and this is something to consider for the future, but again, not at this point in time.
Speaker Change: Okay.
Anat Cohen: And that actually takes me to your second question about additional tumor types. I think that, with the data that we have in hand on COM701 activity, in non-inflamed tumor types, across indications where PD-1 is really not, the populations are not responsive to PD-1 inhibition or very, or only respond to a very low extent. We have data across indications, and COM701 is active. Other than putting our resources and focusing now on platinum-resistant ovarian cancer, which we really have a package of data and additional 20 or more than 20 patients' worth of data will really help us make decisions about how to move forward there, I think that the field is open for us to pursue different types of paths.
Speaker Change: And then sorry actually it takes me to your second question about additional any additional tumor types I seem to Dutch and you know we did data that we have in hand on cultural unwanted activity in non inflamed tumor types across indications, where PD, one is really and not to the population center.
Speaker Change: Not responsive to PD, one inhibition or very.
Speaker Change: And our Oh responses to a very low accident.
Speaker Change: We have Dan across indications and constant and one is exchange and.
Speaker Change: Other than putting our reshoots offence, focusing now on platinum resistant ovarian cancer, which we really haven't package of data and Additionally, as you know additional 20 or more than 20 patients and workshops data, we really hadn't phosphates makes it makes the decision about how to move forward there.
Speaker Change: I seem to destiny does to the field is open for us for different.
Speaker Change: Type a fan and patch aimed in noninterest indications.
Anat Cohen: In the non-inflamed indications, but also in the inflamed indications. Obviously, we've never tested inflamed indications, and we had a reason why we didn't do it. PVRIG Biology gave us an edge in these non-inflamed indications, and we could prove COM701 activity in combination in single-arm studies without asking the question, is it PD-1 inhibition that is generating this activity? And we could do all the work and show in biopsies that this is the mechanism of action.
Speaker Change: Also being flamed indications, obviously, we've never tested and claimed indication says and we had the reason why we didn't do anything PV argue biology gave us an edge in D C and non inflamed indications and we could move com seven one activity in combination and single arm studies.
Without asking the question easy PD, one inhibition that is generating do such D. G and we could do all of the work and showing bus seafood dishes constantly wrong mechanism of infection.
Anat Cohen: And also another path is to combine it with the non-ion combinations, but really... We are now at the state that we're focusing on platinum-resistant ovarian cancer, and we will make the decisions during the year about how we move forward in this indication. And maybe I would add that...
Speaker Change: And also another pass these two combined with the non I O combinations, but really.
Speaker Change: We are now and just take that we're focusing in platinum resistant ovarian cancer and we will make the decisions during the year and how we move forward then into syndication.
Speaker Change: And maybe I would add.
My questions guys.
Eran Ophir: So maybe I will just add that, in addition to what we're focusing on at the moment, you pre-identify a few indications which dominant P-vertebrate pathway. Ovarian is one of those, but there are other indications, for example, like non-spot cell anchors, as Anat mentioned, in more inflamed settings. So definitely, there are multiple opportunities, and combining this with the safety profile of COM-71, that really will enable us to make safe combinations, maybe in other indications, maybe in early lines. So again, the opportunities are there and are quite a few, but we are focusing now on ovarian cancer, for which we have C-19 now, quite promising data.
Speaker Change: So maybe I will just add that the evolution towards focusing on at the moment.
Speaker Change: We will present the final few indication was dominant Beavers Chipotle variant is one of those but there are other indications for example, like non small cell lung cancers are not mentioned more insulated settings. So definitely there are multiple opportunities and combining this with the safety profile of considering the ones that really will enable us safe combinations may be another indication maybe in Italy lines. So again the opportunities.
Speaker Change: On the dividend.
Speaker Change: There are quite a few but we are focusing now on the ovarian cancer, which rather seemingly quite promising data.
Speaker Change: Thanks, guys.
Operator: The next question is from Daina Graybosch of Lierink. Please go ahead.
The next question is from Dana Gray Bosch of Leerink. Please go ahead.
Daina Michelle Graybosch: Hi, thank you for the question. I'm going to continue this line of discussion on your strategy for PVRID going forward.
Speaker Change: Hi, Thank you for the question I'm going to continue this line of discussion on your strategy for P. B R. A T going forward and in ovarian and in particular I wonder how you're considering combining with other standard of care agents.
Speaker Change: Chemotherapy or veg F Bevacizumab and <unk>.
Speaker Change: Reflecting on the past and colorectal.
Speaker Change: You know there's one path that is feeding that you can get a pure I O therapy to work and there's another path. Other says hey taken in these difficult humorous to do combinations and of course to get that signal that takes a different kind of study and I wonder how you're considering that and it reminds me that at one point you had.
Speaker Change: Yeah.
Speaker Change: Planned a chemo combination I think in lung cancer.
Speaker Change: I'm not sure you ever started enrolling that.
Speaker Change: So again remind us why you didnt start enrolling that and what a path.
Speaker Change: Our specific task you would see in lung cancer.
Speaker Change: Should we get to that point. Thank you.
Anat Cohen: And in ovarian cancer, in particular, I wonder how you're considering combining with other standard of care agents, like chemotherapy or VEGF, as a mab. And just reflecting on the path in colorectal cancer, you know, there's one path that is seeing if you can get a pure IO therapy to work. And there's another path others have taken in these difficult tumors to combine them. And, of course, to get that signal, that takes a different kind of study.
Thank you Dana and I stopped in their own Michelle She did free to chime in I'll start with your variance first I would say that you've asked us about congregation and first I would say that we're focused on defense I O combination that we're pursuing now.
Speaker Change: And we get a package of data that we have and we did it at emission biomarker correlation we feel that if data where repeat itself, we see clinical benefits and.
Speaker Change: And there is a path forward for us they are targeting different type of patient.
Speaker Change: Patient population, so that those that are progressing governments.
Speaker Change: On a D C than does the star or standards of care and those are ineligible, but having said that it is true that combination with chemo Medrad a D C.
Speaker Change: Maybe Renaissance and this is really from based on the mechanism of action.
Speaker Change: P. J R. I G being combined we didn't change the toxic agent.
Speaker Change: And also from the safety profile is and I mentioned two to keep that so this is going to be a very front end.
Speaker Change: And then while we focus on ovarian and get the data from this study we can decide how we move forward.
Speaker Change: Taking into consideration the competitive landscape, obviously in ovarian cancer.
Speaker Change: And with fear see it and as I said, they're less air I'm, Shirley and she wants in each of the indications, but I'm sure. She is.
Speaker Change: I think that's why we see a possibility of moving forward and have you seen vacation.
Speaker Change: In combination with standard of care and again here Mechanistically and safety wise.
Speaker Change: Or in earlier nice I seem to death.
Speaker Change: Risk profile and this is for this stage of the company the risk profile in MSS CRC. We believe are unmatched and is the ease of profiles that we sold that at this time, we shouldn't we shouldn't focus and put our resources, but still decent door.
Speaker Change: Is open to being per student in the future. So desperately are suites.
Anat Cohen: And I wonder how you're considering that. And it reminds me that at one point you had planned a Chemo Combination, I think, in Lung Cancer. And I'm not sure you ever started enrolling that. So again, tell us why you didn't start enrolling that and what a specific path you would see in lung cancer should we get to that point. Thank you.
Speaker Change: And I have no idea I didn't ask about CRC I asked about non small cell lung cancer.
Anat Cohen: Thank you, Daina. I'll start, and Eran and Michelle, feel free to chime in. I'll start with the ovary. First, I'll say that you've asked us about combinations, and first, I'll say that we're focused on this I.O. combination that we're pursuing now. With the package of data that we have, with the initial biomarker correlations, we feel that if this data repeats itself, we'll see clinical benefits, and there is a path forward for us targeting different types of patient populations.
Speaker Change: What would be potential borrowers there.
Speaker Change: Yes, and and if it's correct than we planned at a certain point in time to move based on the data that we have just around mentioned it data in Ah patients. It's already experienced checkpoint blockade, we had very nice data seven page.
So that's very nice data.
Speaker Change: And we and social first J&J non small cell lung cancer, which we get chemotherapy.
Speaker Change: And as a small study.
And the reason that we decided to focus on the 19 changing Vacationship deangelis. Due date was the fact that we were.
Speaker Change: We did have communications that we had at that time, we decided to focus on indications, where we will not need large studies in order to prove that.
Speaker Change: The activity of constant NOI combinations.
Ed: And she did on our small studies that we can tease out the contribution of constant my wife would take and move forward and this is Ed on the table and as I said as a company generally were thinking evolved indications we can pursue in time.
Ed: Bye Bye ourself and indications we may pursue as I was saying all the time partner agents also a priority for us and larger indications that could be pursued.
Ed: And in partnerships.
Anat Cohen: So those that are progressing on ADCs or standards of care, and those that are ineligible, having said that, it is true that in combination with chemo, VEGF, ADCs may be relevant, and this is really based on the mechanism of action of PVR-IG being combined with a cytotoxic agent. And also from the safety profile, as Eran mentioned, to STICA. So this is on the ovarian front, and while we will focus on ovary cancer and get the data from this study, we can decide how we move forward.
Speaker Change: And Iran, Michelle anything dragging a variant and non small cell lung cancer combination.
Anat Cohen: Taking into consideration the competitive landscape, obviously in a very intense, And with CRC, and as I said, let's run Michelle and Ed if they want on each of the indications, but in CRC... I think that while we see a possibility of moving forward in this indication in combination with standards of care, again here mechanistically and safety-wise, And or in earlier lines, I think that the risk profile, this is for this stage of the company, the risk profile in MSS CRC, Wheatly Vermeer, and is a profile that we saw that at this time we shouldn't we shouldn't focus and put our resources but still this door is open to being pursued in the future.
Speaker Change: Oh.
Speaker Change: Okay.
Michelle Mother: I was just going to emphasize again, what you were saying and that's because when we look across the indications that we've presented data in we definitely do see.
Anat Cohen: Anat, I didn't ask about CRC; I asked about non-small cell lung cancer. And this is correct that we planned at a certain point in time to move, based on the data that we had that Eran mentioned, data in patients that had already experienced checkpoint blockade. We had very nice data, seven patients though, but very nice data, and we thought of pursuing non-small cell cancer with chemotherapy as a small study. And the reason that we decided to focus on the non-inflamed indications at the end of the day was the fact that we were with the test limitations that we had at that time; we decided to focus on indications where we would not need large studies in order to prove the activity of COM-701 combinations, a singular small study that we could tease out the contribution of COM71 quickly and move forward.
Speaker Change: A <unk> effect driven by call. It 701, so I think that they are opportunities.
Anat Cohen: And as I said, as a company in general, we're thinking about indications that we can pursue internally by ourselves, an indication that we may pursue, as I was saying all the time, partnering is also a priority for us, and larger indications that could be pursued in partnership, and Eran, Michelle, anything to add to ovarian and north Musseline cancer combinations?
Speaker Change: Even with in other indications like.
Speaker Change: The trail breath, when we presented data before and.
Speaker Change: We are considering a lot of different options to have them.
Speaker Change: More robust sort of strategy moving forward.
Speaker Change: <unk>.
Eran Ophir: And I think, you know, at this point in time, we're focusing on pure IO. We have strong data from preclinical to clinical. This is really a strong immune modulating regime that has an excellent safety profile. It's chemo-free, it's really attractive, and the data we've seen so far in ovarian and some of the other indications really pushes us to continue and explore this IO pure combination. But again, doing other combinations, if we need them, or maybe in some indication of when we'll need them, is definitely an approach, and there's a rationale for that.
Michelle: I was just going to emphasize again what you were saying, Anat, because when we look across the indications that we've presented data for, we definitely do see an effect driven by COM 701. So I think that there are opportunities, even within other indications like endometrial breadth where we've presented data before and we are considering a lot of different options to have a more robust sort of strategy moving forward. And I think, you know, at this point in time, we're focusing on pure IO.
Speaker Change: And I think you know at this point in time, we're focusing on the pure Yo nowhere strong data from preclinical to clinical it. This is really strong immune modulating regime.
Speaker Change: Excellent safety profile, it's chemo free its really attractive and in the data we've seen as you know in ovarian and it's all of the other indications really pushes us to to keep continuing to explore this this io.
Speaker Change: Combination but.
Speaker Change: Again doing other combinations, if we need or maybe in some indications in which we will need it is definitely an approach and there is the rationale for that.
Eran Ophir: I mean, the unique biology of PVRIG, the ability to prime new T-cells, is there is a rationale to combine it with ADCs of chemotherapy with the enhanced immunogenicity that they can enhance. There's a rationale to combine it with BEV with the effects of T-cell infiltration. So, moving forward, we definitely consider the data, the indication, and other rationale-based indications that we may consider in the future
Speaker Change: The unique biology physiology, the ability to prime new T cells is there was the Russia to combine with ADC the chemotherapy with the.
Speaker Change: Enhance immunogenicity that enhance the rationale to combine with bev with the effects of this infiltration. So moving forward, we definitely consider the data the indication another irrational based indication that we may consider in the future.
Speaker Change: Great. Thanks.
Operator: The next question is from Tony Butler of Rodman and Renshaw. Please go ahead.
Speaker Change: The next question is from Tony Butler of Rodman and Renshaw. Please go ahead.
Speaker Change: Yeah.
Unknown Executive: Good morning and thank you, Annette. With respect to the ovarian cancer data set that's forthcoming, will that data also include patients who are actually segmented by Positivity with PVR-L2? Part A of that question, number two is, you mentioned a biomarker strategy, I believe, for moving forward with a larger, potentially registrational trial. Have you settled on, and this may be for Eran, an H score, as I recall? Those individuals who had clinical benefit had scores that were, I guess, relatively high, 300 or so, and then the third point is, while I assume all ovarian cancer patients will have had BEV, is there a reason why you wouldn't, they would not want to stay on BEV, even if, in fact, it has, you know, marginal activity, certainly at single age. Thank you very much. Oh, and one last point; it's 20% the hurdle rate for which we should be looking forward toward the fourth quarter for that data set. Thanks.
Unknown Executive: Good morning, and thank you.
Unknown Executive: With respect to ovarian cancer.
Unknown Executive: Dataset that's forthcoming.
Unknown Executive: Data also in food.
Unknown Executive: Patients who are actually segmented bodies.
Speaker Change: <unk> positivity with P D R.
Speaker Change: I will too.
Speaker Change: That's part.
Speaker Change: Hey, I've got question number two is you mentioned a biomarker strategy I believe.
Speaker Change: For moving forward with a larger potentially registrational trial.
Speaker Change: Have you settled on.
Speaker Change: Maybe for Iran.
Speaker Change: Settled on an H scores on coal.
Speaker Change: Those individuals who had clinical benefit scores that were.
Speaker Change: It's relatively high 300 or so.
Speaker Change: And then the third point is.
Speaker Change: While I assume all ovarian cancer patients who have had.
Speaker Change: There a reason why you wouldn't they would not want to stay on that.
Speaker Change: Even if in fact, it has no marginal activity certainly the single agent.
Speaker Change: Thank you very much hope and one last point is 20% the hurdle rate.
Speaker Change: For which we should be looking toward full toward.
Speaker Change: Our fourth quarter for that dataset.
Anat Cohen: Thank you, Tony. So I'll let Michel answer the best question.
Unknown Executive: Thank you Tony and so I left hand shall answer that first question I'll start with that what you asked about the biomarker and lesser on related to the H score.
Anat Cohen: I'll start with what you asked about the biomarkers and later on relate to the age score. First, I'll say that in terms of data, yes, we present data that relates to activity, to the efficacy, the durability, translational, the data that we'll have in hand. We also anticipate to share PVRL2 or biomarker data, obviously, depending on the data, the work in progress now, and with the data that we'll have in hand, we'll present what we have in hand.
Speaker Change: And first I would say again in terms of the data and yes, we presented data that relates to the N. G. E X T V teacher secrecy that durability of translation and the data that we don't have in hand.
Speaker Change: And we also anticipate two sure P J Aron to biomarker data and obviously, depending on the data the work in progress now and and we debated it will having hence would prevent foresee having him and we say before I left are unrelated to the H score and we.
Anat Cohen: I will say, before I relate to the ACE score later on, I will say that we will look at the data, and different bars of data will allow us to make a decision: do we go with or without the biomarker? We're not limiting ourselves to a biomarker. This is an enrichment strategy that may help. It will depend on the data that we'll have in hand, but we're not ruling out a study that will not be biomarker-driven, maybe a study that will still continue to assess the biomarker findings. It really depends on the data that we'll have in hand. Eran, do you want to take the ACE score one? Yes. So, yes, Tony, you remembered correctly.
Speaker Change: I'd say that we will look at the data and and a different bar still stays time will allow us to make a decision do we go where we don't read all of the biomarker, we're knocking anything garces with biomarker. This is an enrichment strategy than they had before.
Speaker Change: We depend on the data that we'll have in hand, but were not willing go to study that we not be biomarker driven maybe you're starting to get we still continue to assess the biomarker are finding it really depends on the data that we have in hand.
Speaker Change: And Ron do you want to take the H score one.
Eran Ophir: Yes, so yeah, Tony, you remembered correctly. We made a very important observation from a previous study in which we showed that the patient who responded, had clinical benefit from the treatment of the COM7-1 combination, had a higher age score of PVRL2, and this opened the door for a potential biomarker, yes, to enrich for these patients who have long, durable responses and then, of course, to move to registration faster and all the benefits of having a biomarker.
Speaker Change: So yeah, Tony remembered correctly. This is a very important observation for a previous study which we.
Speaker Change: Showed that the patients who responded had clinical benefit from the treatment of the convertible non combination.
Speaker Change: It had a school people too and this open the door for a potential biomarkers to enrich for these patients who have long durable responses and then of course to move to recession faster and all the.
Speaker Change: The benefits of having the biomarker. So this work is ongoing also in this study to define the cutoff, obviously, we need to show also in this study that the phenomenon repeats itself. When it's really defined looking at now will have much more patients combining the studies together, we can really look at the totality of the data the response rate the correlation to the school and density.
Eran Ophir: So this work is ongoing in this study, too. To define the cutoff, obviously, we need to show also in this study that the phenomena of PC cells really need to be defined, looking, and now that we have many more patients combining the studies together, we can really look at the totality of the data, the response rate, the correlation to the age score, and then define the actual cutoff if and when we will move forward with a biomarker-selected study. So this is ongoing.
Speaker Change: Find the actual cutoff, if and when we would move forward with a biomarker selective study. So this is ongoing.
Speaker Change: Yeah.
Eran Ophir: Do you want me to comment on the birth? Yeah, Michelle, go ahead.
Speaker Change: Do you want me to comment on the best Yeah. Go ahead, yeah. So you know in the initial lines of treatment in these patients they do get bevacizumab together with platinum platinum so basically the mainstay of therapy in the ovarian cancer population generally.
Michelle: Yeah, so, in the initial lines of treatment in these patients, they do get bevacizumab together with platinums. Platinums are basically the mainstay of therapy in the ovarian cancer population. Generally, if a patient does relapse following a full regimen, which includes bevacizumab maintenance, they may get put on the PARP inhibitors as second line, or sometimes they'll do it the other way around. They generally are not repeated. You know, they might repeat BEV, but it's really more about repeating the platinum agents until the patient becomes resistant. So that's defined by a platinum-free interval of six months or less. And the patients that have been enrolled in our studies so far are the platinum-resistant patient population.
Speaker Change: If a patient does relapsed following a full regimen, which includes bevacizumab.
Speaker Change: Maintenance they may get put on to the pop inhibitors as second line or sometimes they'll do it any other way around the generally are not repeated they might peak beds, but it's really more repeating the platinum agents until the patients become resistant so that the five.
Speaker Change: And by a platinum free interval.
Speaker Change: Six months or less and then he patients have been enrolled on our studies. So far are the platinum resistant patient population.
Speaker Change: Okay.
Speaker Change: Thank you very much.
Speaker Change: Okay.
Speaker Change: Okay.
Operator: 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 comps you Jens Investor.
Speaker Change: Conference call. Thank you for your participation you May go ahead and disconnect.
Speaker Change: Yeah.
Speaker Change: Yeah.
Speaker Change: [music].
Speaker Change:
Speaker Change: Yeah.
Speaker Change: [music].