Compugen Ltd. (CGEN) Q1 2021 Earnings Call Transcript

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Compugen Ltd. (CGEN -3.54%)
Q1 2021 Earnings Call
May 13, 2021, 8:30 a.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Ladies and gentlemen, thank you for joining us today. Welcome to Compugen's First Quarter 2021 Results Conference Call. [Operator Instructions] With us from Compugen are Dr. Anat Cohen-Dayag; Ari Krashin, CFO and COO; and Dr. Henry Adewoye, Chief Medical Officer, who will be available for questions at the end of the call.

Before we begin, I would like to read the following regarding forward-looking statements. During the course of this conference call, the company may make projections or other forward-looking statements regarding future events or future business outlook, our development efforts and their outcome, our discovery platform, anticipated progress and timeline 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 on the company's current expectations and that actual events or results may differ materially. You are kindly referred to the risk factors and cautionary language contained in the documents the company filed with the Securities and Exchange Commission including the company's most recent annual report on Form 20-F filed on February 25, 2021. The company undertakes no obligation to update projections or forward-looking statements in the future.

I would now turn over the call to Anat. Anat?

Anat Cohen-Dayag -- President and Chief Executive Officer

Thank you, operator. Good morning and good afternoon everyone and welcome to our first quarter 2021 corporate and financial update. We have started 2021 from a strong position building on our timely execution for our 2020 guidance and plans. We believe 2021 is posed to be an important year for Compugen as we continue our efforts to build a robust clinical pipeline with multiple clinical studies, while further deepen the scientific foundation for our differentiated programs. We have developed a comprehensive clinical development program designed to systematically elucidate the role of our internally discovered and wholly owned anti-PVRIG and TIGIT assets across settings and combination regimens. With steady execution, we have made great progress, both clinically and research wise in understanding the role of the DNAM axis members, PVRIG and TIGIT, as potentially foundational immunotherapy checkpoint targets.

Our work has identified PVRIG and TIGIT as key parallel and complementary inhibitory pathways in the DNAM axis, which also intersect with the well-established PD-1 pathway. Together, our data suggest that these three inhibitory pathways have different dominance in different tumor types in patients, which means that in order to induce effective antitumor responses, certain patient populations may require the blockade of different combinations of these three pathways. With this in mind, we have established a science driven and data informed clinical program, which evaluates different combinations of these axis members across indications that we believe will be most relevant in the clinic.

On our last call, we shared data from the combination arm of the Phase I dose escalation study of COM701 in combination with Bristol Myers Squibbs nivolumab as well as follow-up data from our monotherapy dose escalation and cohort expansion study. For the combination arm dose escalation, we provided complete data from all five dose levels in the study. Our encouraging results showed a disease control rate of approximately 67% which is a significant accomplishment given the highly refractory, heavily pre-treated and advanced disease patient population. Equally important are the observed durable responses in multiple patients and across indications, which include patients with complete and partial responses, with patients on study treatment for almost a year or in some cases for more than a year.

An additional meaningful highlight from these updated data relates to the patient with the complete response, who prior to being enrolled in our study, had disease progression on a checkpoint inhibitor. This data suggests the dual blockade of PVRIG and PD-1 may be key to driving antitumor immune responses in certain patient populations. These readouts are particularly significant, given our latest announcement of our expanded clinical collaboration with Bristol Myers Squibb to initiate a Phase Ib dual combination expansion study of COM701 in combination with nivolumab which is expected to begin in the second quarter of 2021. This study will enroll patients with ovarian, breast, endometrial and microsatellite stable colorectal cancer and is an important addition to our clinical strategy expanding the potential reach of this combination regimen, while also providing insight toward the contribution of the different components of the DNAM axis across our ongoing and future COM701 studies and specifically our ongoing triplet study of COM701 with nivolumab and Bristol Myers Squibb's TIGIT inhibitor.

We also shared initial data from our COM701 monotherapy cohort expansion, a safety and tolerability study with a biomarker informed strategy to select tumor types most likely to respond to treatment based on pre-clinical expression data and clinical results from the dose escalation arm. These indications are endometrial, breast, ovarian, colorectal and non-small cell lung cancer. Enrollment of 20 patients in this study was completed in the fourth quarter of 2022. As of the data cut-off date, we presented last quarter six out of the 20 patients had the best response of stable disease across endometrial, non-small cell lung and ovarian cancer and two patients with durable antitumor activity continuing on treatment. This data combined with our COM701 dose escalation data provides signals of antitumor activity in a monotherapy setting in tumor types typically unresponsive to immune checkpoint inhibitors.

In addition, some of these single agent signals are durable including a patient with a confirmed partial response from the dose escalation study on treatment for over one year as of the data cut-off date presented last quarter. It should be noted that these were highly refractory patients. We exhausted all treatment options with tumor types that are typically non-responsive to checkpoint inhibitors including patients with prior progression on these treatments, which together suggests the PVRIG blockade may be an important untapped checkpoint that has the potential of driving antitumor immune responses.

The clinical data across the combination in monotherapy arms leaves us increasingly confident in our prediction that there are certain patient populations, which are likely to respond to PVRIG blockers and/or PVRIG and PD-1 dual blockade including those that have progressed on immune checkpoint blockers. Another angle to evaluate the activity of COM701 is the data analysis in progress from the COM701 monotherapy cohort expansion study that will include correlative assessments based on data from patient samples including cytokines, immunophenotyping and immunohistochemistry analysis. This data that will also be gathered from our dual and triple combination studies, will enable us to gain insights relating to COM701 and PVRIG, PVRL2 pathway biology particularly in indications that are typically not responsive to PD-1 blockade. Our initial assessments of patients peripheral blood samples suggest that COM701 may enhance immune activation in cancer patients alone or in combination with nivolumab.

These results provide for the first time an indication for the potential effect of PVRIG blockade in peripheral blood of cancer patients treated with COM701. We are excited to be providing updated data from the COM701 monotherapy in combination with nivolumab studies in our upcoming oral presentation at ASCO on June 7, 2021, and look forward to sharing the data following our oral presentation. We continue to invest in our clinical programs and have expanded our clinical strategy to include multiple clinical studies in order to maintain our leadership position in the evaluation of the DNAM axis pathway.

Moving forward in 2021, we expect to continue to execute across our broad clinical strategy, which includes the ongoing triplet study of COM701 with nivolumab and Bristol Myers Squibb's TIGIT inhibitor. The initiation of the doublet expansion study of COM701 with nivolumab in the second quarter of 2021, the ongoing dose escalation of COM902 our wholly owned TIGIT inhibitor and following the completion of the COM902 dose escalation, the initiation of the doublet study of COM701 and COM902 in the second half of this year.

With these studies in place, we are positioned to rapidly generate multiple data readouts that will be key for our development of DNAM axis based new cancer immunotherapy. Our Phase I/II triple combination study evaluating the safety, tolerability and preliminary antitumor activity of COM701 in combination with Bristol Myers Squibb's TIGIT antibody and nivolumab is currently enrolling patients and we expect to share initial data from the dose escalation portion of the study in the fourth quarter of this year. The purpose of this study is to allow the testing of our triple blockade hypothesis that blocking the three intersecting PVRIG, TIGIT and PD-1 pathways has the potential to synergistically enhance antitumor immune responses in selected patient populations not responsive or refractory to PD-1 blockers.

Another ongoing trial, the COM902 monotherapy dose escalation study is an important component of Compugen's overall strategy. We have seen the growing interest in TIGIT inhibitors, which now include multiple clinical stage programs and we're closely following the development in this space. We firmly believe it is important to pursue the development of our own candidate to maintain our control of what we believe are two key arms of the DNAM axis and our ability to independently evaluate multiple combination approaches, which includes TIGIT in the clinic. Advancing COM902 through dose escalation and future combination studies is important for our position in the PVRIG, TIGIT space. We expect to provide initial data from COM902 dose escalation study in the fourth quarter of this year and are on track to begin studies evaluating COM701 in combination with COM902 in the second half of this year.

The preclinical data we published in Cancer Immunology, Immunotherapy strengthened our confidence in our clinical approach providing important information on the underlying biology of TIGIT and its potential synergies with other immune checkpoints, which we can leverage in our clinical strategy. This data together with our internal PVRIG research allows us to focus and refine the indications we will pursue in the clinic to potentially maximize the probability of success of our combination strategy of COM701 and COM902.

In addition, our research further demonstrates the absence of T-cell depletion activity in vitro and in vivo with COM902 and therefore reinforces our COM902 approach which was designed to have reduced Fc receptor engagement to avoid potential depletion of TIGIT expressing effector T-cells. As you can see from our various scientific publications, we continue to invest in high-quality in-house research that feed our clinical pipeline strategy in order to keep it differentiated and competitive.

Our progress from target discovery, validation and preclinical development now through to a comprehensive clinical program has been remarkable. Our discovery of the previously unknown PVRIG pathway uncovered this immuno-oncology pathway and our research and clinical work have supported our position as leaders in the DNAM axis space, which has been highlighted by our status as the only company with a wholly owned clinical stage assets targeting both PVRIG and TIGIT and thus the only company currently capable of evaluating in the clinic PVRIG monotherapy, dual blockade of PVRIG with PD-1 or TIGIT and triple blockade of PVRIG with PD-1 and TIGIT.

We are highly enthusiastic about what's to come later in the year, most importantly initial data from our dose escalation triple combination study. Our Phase I/II triple combination study designed as a study in ovarian and endometrial cancers and additional tumor types with high PVRL2 expression is the ultimate test of our hypothesis and a true differentiator in the crowded immuno-oncology space. Beyond this exciting clinical progress, we are also continually driving forward our science, which has been the foundation that underlies our clinical progress. Our recent publications in Cancer Immunology, Immunotherapy and cancer discovery are testament to our scientific rigor and broader contributions to the fundamental biology of the DNAM axis. We will continue our efforts to drive the science forward, building upon our deep scientific heritage that we believe plays an integral role in our potential success. A key factor in driving our science forward involves the advancement of our early stage pipeline with multiple programs targeting the immunosuppressive tumor microenvironment including targeting the myeloid population, which we believe will fuel long-term growth and opportunity for Compugen. The expansion of our fruitful research collaboration with John Hopkins University to include focused research on a Compugen discovered novel myeloid target, reinforces our ability to further discover completely new drug targets and our continued focused research and development on early stage programs along our clinical development execution.

We are proud to continue this long standing collaboration addressing our multiple drug candidates with Dr. Drew Pardoll, who played an important role in the preclinical development of COM701 and look forward to collaborating with his incredible team to advance a novel immune oncology agent that has the potential to target tumor-associated macrophages in the tumor microenvironment. We are excited by this novel myeloid target, and although this is very early days, we hope that through rigorous and deep research, we will build a strong foundation that can ultimately translate this very early stage program to a first-in-class clinical candidate. And while our progress in the clinic has been a major focus, we have been in parallel advancing programs like this one, along with additional later stage programs to continue our science driven approach to discover and develop novel immuno-oncology targets. We will continue to push the science forward and look forward to maturing these programs to a stage where we will be able to disclose more information in terms of target and our future strategic path. Investing in our early stage programs in pipeline growth engine remains high priority for Compugen and we believe in the potential of our platform to uncover additional untapped novel immuno-oncology targets just as we did with the DNAM axis.

Finally, before turning the call over to Ari. I would like to thank the team at Compugen, our partners, investigators, shareholders and patients. The dedication and contributions across these groups are what have enabled us to continue our on-track execution and progress despite the still ongoing COVID-19 pandemic. We are proud to have our prior guidance for enrollment and data across our studies unchanged.

And with that, I will turn the call over to Ari to review our financials.

Ari Krashin -- Chief Financial and Operating Officer

Thank you, Anat. Good morning and good afternoon to everyone. Our financial results for the first quarter of 2021 released this morning continue to reflect a solid financial position with as expected increased research and development expenses due to our growing number of clinical trials. Research and development expenses for the first quarter of 2021 were $7.3 million compared with $4.7 million for the same period in 2020. This increase is attributed mostly to CMC related activities, specifically manufacturing cost for additional drug supply of COM701 to support the planned expansion of our various clinical trials as well as expanded clinical team located in the U.S., which brings additional expertise to the company to ensure the successful management and execution of our ongoing and soon to be initiated clinical trials. As a reminder, our clinical expenses reflect costs associated with our expanded clinical programs, which will now include COM701 in monotherapy dual and triple combination studies, as well as dose escalation study for COM902.

Net loss for the first quarter of 2021 was $9.9 million or $0.12 per basic and diluted share, compared with a net loss of $7.1 million or $0.10 per basic and diluted share for the same period in 2020. As of March 31, 2021, we had approximately $119 million in cash and cash related accounts compared with approximately $124 million as of December 31, 2020. The company has no debt. The decrease in our cash balances of approximately $5 million net during the first quarter represent approximately $9 million of gross cash expenditures offset by collection of $2 million from AstraZeneca related to the revenues recognized in the fourth quarter of last year and $2 million of working capital. As a reminder, we expect our gross cash expenditures for 2021 to be in the range between $40 million to $42 million without taking into consideration any potential cash inflows for the company from existing or new collaborations.

Thank you. And with that, we will now open the call for questions.

Questions and Answers:

Operator

Thank you. [Operator Instructions] The first question is from Mark Breidenbach of Oppenheimer. Please go ahead.

Mark Breidenbach -- Oppenheimer & CO -- Analyst

Hey guys, congrats on all the progress. And I hope everyone is staying safe on your end. Just a couple from me. First of all, should we be expecting any additional patients from either the monotherapy or nivolumab combination cohorts to be included in the analysis presented at ASCO versus what we saw in February or will it really just be the same set with more follow-up time? And you mentioned that there might be some correlative data presented at ASCO as well. I'm wondering if you were able to track any specific markers of DNAM-1 activation or will these correlative data really be more generalized indicators of immune activation and response.

Anat Cohen-Dayag -- President and Chief Executive Officer

So, I would take the corrective assessments and let Henry relate to the clinical on the correlative assessments. As we stated in our last quarterly call, we were able to track with very initial data obviously immune activation seen by COM701 treatment as monotherapy and also in combination with nivolumab. So this data will be presented. With respect to DNAM axis, this is really analysis in progress and if we'll show some data, it would be very, very initial. We will present the data as we will have it ready probably in additional later conference. Henry.

Henry Adewoye -- Senior Vice President and Chief Medical Officer

Thank you. So Mark, what we previously disclosed in February was a snapshot of the data. At ASCO, we'll present updated data including all the patients who have been enrolled on the dose escalation arms of the study. So monotherapy dose escalation, the combination dose escalation including follow-up. We'll also disclose data on the patients who have been enrolled on the monotherapy expansion cohorts including follow-up on those patients also. And particularly, we will disclose data on long-term patients who have been on the study and especially the ones that we've highlighted in the prior disclosure we had in February. So, it will be summary of all the data that's been previously disclosed and new data, specifically new data in the last dose cohort of COM701 in combination with nivolumab both [Phonetic] at the doses of 20 milligrams per kilogram body weight dose and for 80 milligrams IV Q4 weeks. So, there'll be a lot more of the safety data in dose cohorts.

Mark Breidenbach -- Oppenheimer & CO -- Analyst

All right. That's super helpful. Thanks for that. And just also wondering if you were able to collect any postmortem biopsies from patients in Phase I study who were on drug at the time of death just to be able to look for any evidence of target engagement and also do a little bit of PVRL2 expression profile in any of the Phase I patients? Thanks for taking my questions.

Henry Adewoye -- Senior Vice President and Chief Medical Officer

Yes, not mentioned in our script, there will be correlative data presented and I would give an opportunity to Anat to further expand it [Phonetic] on your question.

Anat Cohen-Dayag -- President and Chief Executive Officer

Yeah, we were collecting on the monotherapy expansion. We're collecting pre-treatment and on-treatment. I am not sure with respect to postmortem. I guess you will need to wait for the -- I'm not sure that we have postmortem for specific patients.

Mark Breidenbach -- Oppenheimer & CO -- Analyst

Okay, fair enough. All right. Thank. Thanks so much for taking the questions and we're looking forward to the ASCO presentation.

Anat Cohen-Dayag -- President and Chief Executive Officer

Thank you, Mark.

Operator

The next question is from Stephen Willey of Stifel. Please go ahead.

Stephen Willey -- Stifel -- Analyst

Yeah, good morning. Thanks for taking the questions. Maybe just a follow-up on the last question. Can you maybe just kind of ballpark with respect to, I guess, how much pre-treatment and on-treatment tumor biopsy data from patients we might see at ASCO? I know you talked about some of the peripheral blood markers of immune activation, but I think there has been some increased interest in the changes in CD8 TIL fraction that are in the tumor both pre-treatment and post-treatment. So just wondering if that's an assessment that we might see at ASCO?

Anat Cohen-Dayag -- President and Chief Executive Officer

So as you correctly stated, we did speak about the blood markers and with respect to liquid biopsies we obviously have from the dose escalation as well as from the expansion, so here we have a little bit more -- the number is a little bit higher. On the tumor biopsies if you remember, we had 20 patients in the monotherapy expansion. Obviously, we couldn't get biopsies from all of them as paired pre-treatment and on-treatment. So, it's only a portion of this group. And taking into consideration that, in some of them, obviously, we didn't see response. So I think that the data will be limited, its initial. The data that we have is pointing to some preliminary, as we stated preliminary activation upon COM701 treatment. What we are going to present will probably not be all the Immunohistochemistry data because this is in progress. We will present some of the data that we have. So just to address your question, it will be limited at this point in time, but we will make sure that we present all the data when we have it probably in a later conference.

Stephen Willey -- Stifel -- Analyst

Okay. That's actually quite helpful. And then maybe just to throw a question at you that we're getting a lot. I know that there is competitive trial readout, I think coming maybe later this quarter. One of the backbone agents in that regimen that's being evaluated is an Fc-silent TIGIT. So just kind of wondering what you're maybe expecting to see out of that? And I guess how you think that data might extrapolate out to what you're pursuing with COM902 right now? Thanks.

Anat Cohen-Dayag -- President and Chief Executive Officer

Yeah, it's a fair question that you know that will be the first data that is derived from an Fc inactive TIGIT inhibitor as opposed to the rest of the data that is out there. So obviously we're looking as well to see what the data will tell us. I guess that you are well familiar and not [Indecipherable], but also the community with our view about the need or -- or actually the no need from our perspective as we see based on our data on having an Fc-active. We hope this will support this view that we have, which is based on data we recently published, a paper on COM902, which is further strengthening what we were saying for quite some time. We have our own COM902 clinical study. This is now in dose escalation. We promise to show data in Q4. So, obviously our data will be outside as well. So, we're looking to see what the data will tell us from the other company, but also we are looking very carefully at our data as well. And we still didn't find in the public domain a reason to be concerned with our view with respect to Fc-inactive performance in clinical studies. So we'll see.

Stephen Willey -- Stifel -- Analyst

All right. I appreciate the answer. And congrats on the progress. Thank you.

Operator

The next question is from Dana Graybosch of SVB Leerink. Please go ahead.

Dana Graybosch -- SVB Leerink -- Analyst

All right, thank you for the question. A couple on the science side. I think we're seeing more companies talk about targeting Tactile or CD96, sort of the other member that you don't have a program against sort of the DNAM axis. And I wonder, the first question and then I'll have a follow-up. The first is, what do you think about CD96 and its role in DNAM signaling and whether you may need to target it in some patients or tumors as well?

Anat Cohen-Dayag -- President and Chief Executive Officer

Yeah, it's a good question. CD96 actually is a binding PVR, but in binds PVR with the lower affinity than TIGIT. So, we think that the contribution is not really clear. Definitely PVRIG is addressing a completely different node which is PVRIG PVRL2. We believe that the PVRIG PVRL2 and TIGIT PVR are the two pathways that needed to be blocked in order to generate full [Phonetic] antitumor activity. I'll say it that also the -- the CD96 is a positive co-stimulatory or negative co-stimulatory that's also a question at least in our hands and in some papers outside. So we'll see, we'll wait and see. But it doesn't change our hypothesis.

Dana Graybosch -- SVB Leerink -- Analyst

Helpful. And then a follow-up on the question that Stephen just asked on the competitor data. I wonder if you could remind us how similar are COM902 [Indecipherable] going to have the data. Any notable differences in addition to the similarity that we should consider when looking at that data?

Anat Cohen-Dayag -- President and Chief Executive Officer

So first with respect to our antibodies IgG4, I believe there is this IgG1 mutated, but still Fc-inactive. And in general, our antibody is a ultra high affinity antibody. That's an antibody that we've developed from day one to be complementary with COM701 and we tested it also benchmark to other TIGIT antibodies. We don't have a reason to believe that epitopes would play a role here, different epitopes like similarly to PD-1 but generally the difference is the ultra high affinity with respect to our antibody. So we'll see.

Dana Graybosch -- SVB Leerink -- Analyst

Helpful. Thank you very much.

Anat Cohen-Dayag -- President and Chief Executive Officer

Thank you.

Dana Graybosch -- SVB Leerink -- Analyst

The next question is from Ren Benjamin of JMP Securities. Please go ahead.

Reni Benjamin -- JMP Securities -- Analyst

Hey, good morning guys. Thanks for taking the questions. Anat you mentioned that the additional day in the four quarter of this year. Can you give us a sense as to how many patients worth of data, we might be seeing for both studies and would it be enough to make some reasonable conclusions about our path forward?

Anat Cohen-Dayag -- President and Chief Executive Officer

Henry, would you like to address this question.

Henry Adewoye -- Senior Vice President and Chief Medical Officer

Sure. So the two -- Ren, so the two key projected data that will be anticipated will be for the TIGIT antibody like Anat mentioned COM902. So for that, as you know, Reni, it's a design that has an accelerated portion to it. So, we have single dose [Phonetic] subject patient cohorts and also we have a three plus three subject dose level cohort. I cannot project for you now the total number of patients that we will expect to see, but certainly it would be at least more than four [Phonetic] patients that we'll enroll because we'll go past the single subject dose level cohorts. We continue to accumulate data on that study. So maybe at another presentation, we'll be able to hone in more on the absolute number of patients that were projected. Okay.

Reni Benjamin -- JMP Securities -- Analyst

Got it. And then the triple combo?

Henry Adewoye -- Senior Vice President and Chief Medical Officer

Yes. So for the triple combination, we also have that ongoing. It's a three plus three study design also. The projection, when we started that dose escalation study, is to go as high as 20 milligrams per kilogram body weight dose with COM701 in combination with the other two agents. So the other two agents are the BMS-986207, the BMS TIGIT antibody and nivolumab. We, so far, as we keep on, we're on track at a later teleconference, we'll be able to tell you how many patients we expect. But certainly, the reason we are projecting that we'll get up to 20 milligrams per kilogram body weight dose of COM701 in combination with the other two agents is because as you remember the dose that we've recommended for expansion for COM701 is the 20 milligram per kilogram body weight dose IV Q4 weeks. So as we go along, we'll be able to further refine how many patients that will present at that time.

Reni Benjamin -- JMP Securities -- Analyst

Got it. Okay. And then just regarding the biomarker data that you'll be disclosing at ASCO, as well as later on in the year, it seems to me that ultimately you are probably are in search of a patient signature or some sort of signature that might allow you identify patients that would respond right to either COM701 or the combination of COM701 and COM902. Am I thinking about that correctly that ultimately all these analysis will help you to identify the patients better or are you looking at these data more to boost the current clinical benefit rates that you're seeing to more of objective responses or do you kind of feel that [Indecipherable] right now are pretty good and you can get more people with stable diseases that would be just fine?

Anat Cohen-Dayag -- President and Chief Executive Officer

Actually both and also for better understanding the mechanism of action of COM701 treatment. The biomarker strategy is broad enough in order to address tumor biopsies and also information gathered from blood samples. We have the component of the retrospective analysis and you also know that we have the component of patient selection basket study in the triplet. We are looking to understand what the tumors are telling us following COM701 treatment, monotherapy or combination and whatever we can get to better understand what's going on in tumor microenvironment remodeling etc. So both goals that you mentioned, but also better understand the mechanism of action.

Reni Benjamin -- JMP Securities -- Analyst

Got it. I guess just one final question for me, I'd love to just kind of get your thoughts on the TIGIT landscape as you see it right now, how it's unfolded, what's the data that we've seen to date and kind of how COM902 might be able to sort of thread the needle in the space?

Anat Cohen-Dayag -- President and Chief Executive Officer

I'll let Henry address it, but I'll just say that currently the TIGIT studies that are ongoing across the different indications are mostly PD-L1 high as we stated for quite some time. We believe that PVRIG will be -- targeting PVRIG will be complementary and you can see that our clinical strategy is addressing the more the PD-L1 low and non-responsive patient population. With our TIGIT, obviously, the key differentiating factor is the fact that we can combine it with COM701, but I'll let Henry address more the landscape and our strategy with COM902.

Henry Adewoye -- Senior Vice President and Chief Medical Officer

Yeah. Thank you Anat. So, Reni, I think what's key here is that this provides opportunities for better treatment options for patients who have advanced disease. Most of the data that's been presented prior to the release by Roche-Genentech, was dose escalation by OncoMed-Mereo. Now, we have more data from Roche-Genentech and like Anat alluded to, this is more robust data because it's a randomized study in non-small cell lung cancer. And it appears that the activity of the combination of the TIGIT plus the PD-L1 inhibitor is better enhanced in patients who have high PD-L1 expression. The data from Merck also shows that the combination appears better results in combination with a PD-1 inhibitor. So that's good for patients. What is currently unknown at this time, I don't think personally speaking as an oncologist and looking at all the data that's been there, is whether there will be an impact with the kind of Fc [Phonetic] that one has, we're looking forward to data disclosures by Arcus as we've iterated that we will have an interim analysis of their data. But we believe like Anat has mentioned that COM902 will have anti-tumor activity and that it will as a pure blocker that it will -- probably which will show based on the signs that there should be no difference in terms of whether there is an Fc enhanced and non-Fc enhanced. However, this data all that we are collecting, all ongoing and we'll see what Arcus presents also. I would just like to add that Anat, I completely align with what Anat has said that what actually differentiates Compugen is that we are going to be testing a PD-1 and the PD-L1 free regimen, where it will be the combination of COM902 with COM701 and we'll see what the preliminary safety and tolerability and anti-tumor activity of the combination will be. But also remember that we have a triple combination study that's ongoing in collaboration with BMS, obviously, where we are testing the DNAM hypotheses of complete inhibition of the various aspects of the DNAM axis, so it's all incredible and exciting deal [Phonetic] that we hope to see over the next several months and before the end of the year and hopefully this will all lead to clinical benefit for patients who are desperately in need of better treatment options.

Reni Benjamin -- JMP Securities -- Analyst

Perfect. Thanks very much for taking the questions.

Operator

The next question is from Asthika Goonewardene of Truist Securities. Please go ahead.

Asthika Goonewardene -- Truist Securities -- Analyst

Hi guys, thanks for taking my questions. Can I, I want to revisit something here on the triple, can you tell me what dose level of COM701 that you will begin the escalation? I just want to clarify, are you starting that at a dose at -- with COM701 dose at 20 milligrams per kilograms or something maybe around that area? And then I have another question on the more complete IHC data that you alluded that you will follow-up at a later conference. Will that be something in the second half of 2021 as well that we can expect? Thanks so much.

Anat Cohen-Dayag -- President and Chief Executive Officer

So I'll start with IHC and then Henry will take the triplet dose escalation question. We did not share guidance, but as I said, this is in progress. Hopefully, we can present it this year, but we will give a specific guidance when we know more.

Henry Adewoye -- Senior Vice President and Chief Medical Officer

Okay, all right, thank you, Anat. So, Asthika with regards to the triplet combination what we've disclosed is that we'll will have approximately up to five dose level sequential dose escalation cohorts in combination with fixed doses of the BMS TIGIT antibody 986207 and nivolumab. So, inherently, that means that we will not be starting at 20 milligrams per kilogram body weight dose of COM701 in combination with the other two agents.

Asthika Goonewardene -- Truist Securities -- Analyst

Got it. Thanks guys.

Operator

The next question is from Roger Song of Jefferies. Please go ahead.

Roger Song -- Jefferies -- Analyst

Great. Yes. Congrats on the progress. And that most of my question are related to COM701 and COM902 has been raised and answered. So, I won't repeat. Maybe just a quick question related to John Hopkins collaboration. So, we know the myeloid target is one of the pillar of your competition and discovery platform. Maybe could you just provide some additional color in terms of the nature of the collaboration? And maybe more specifically, what are the steps and the timelines for the candidate nomination and the potential [Indecipherable]

Anat Cohen-Dayag -- President and Chief Executive Officer

Yes, sure. As much as we can relate it, we didn't disclose much, but I'll just say that the collaboration with Hopkins is -- it's very similar to how we conduct a collaboration for few years now. Hopkins is part of executing the research on the candidates. As I stated, they were also part on some of the preclinical work on COM701. So, this is the nature of the collaboration. Specifically for this myeloid target, this is a very early stage 1. It's still merits research in order to explore the therapeutic potential and we believe it's exciting, and as we disclosed, we've seen some tumor growth inhibition in generic depletion animal models. The mechanism seems interesting, but it requires a lot of research and this is why we thought that this is -- it will be good to go hand in hand with the laboratory of Drew Pardoll and his excellent team that we're used to work with them and do the work together. That's what I can say about this specific drug target.

Roger Song -- Jefferies -- Analyst

Great, thanks for the color. Yeah, I won't leave Ari out of this conversation. Maybe, Ari, I believe you could provide some kind of color around the opex and cash. Maybe just remind us to what is the current guidance around the cash runway.

Ari Krashin -- Chief Financial and Operating Officer

Hey, Roger. So, we ended the quarter with about $190 million. As we stated before, the yearly run rate for -- the yearly run rate expenditures would be roughly between $40 million to $42 million. So having said that, assuming we will not increase significantly the cash burn [Phonetic] rate, we are talking about at least cash sufficient through the end of 2023. Having said that, again, if we do decide based on our clinical strategy to expand and to increase the clinical trials, obviously, this estimation might change.

Roger Song -- Jefferies -- Analyst

Great, thank you. That's all. [Indecipherable] again.

Ari Krashin -- Chief Financial and Operating Officer

Thank you.

Operator

The next question is from Tony Butler of Roth Capital. Please go ahead.

Tony Butler -- Roth Capital Partners -- Analyst

Yes. Thanks very much, I appreciate you working me in here. Question, and that in Henry is around COM701 and COM902, the combination trial. Henry you alluded to the fact that for safety reasons, you would want to see that combination. But don't you actually get that with the triple? And I guess outside of dosing that is the amount that you would use optimally with COM701 with the optimal dose for COM902 what else might you actually define if anything for the two --for eliminating both co-inhibitors in the DNAM axis in the absence of a PD-1 antibody?

Henry Adewoye -- Senior Vice President and Chief Medical Officer

Yeah. Tony. Thank you for your question. Remember that in the process of doing a dose escalation study, the intent is to evaluate what the safety and tolerability of that combination that you're testing. So if you have three study drugs that you're combining as part of your dose escalation, it is impossible to be able to extricate what the contribution to safety of either one of the components or two of the components are. You can only speak to what that combination does in terms of safety and tolerability, especially within [Indecipherable] window that you've assigned for the course of the dose escalation and also intermediate and long-term toxicities [Phonetic]. All right. Now for the dual combination -- so, therefore, it will not be possible to lead completely to what TIGIT inhibitor does separately as part of a triple combination, and also remember that even though we get some data from what the combination of a TIGIT inhibitor does as part of that triplet combination of COM701 with [Indecipherable], it's a different TIGIT antibody. So the TIGIT antibody that we're using in the triplet combination is the TIGIT antibody from BMS-986207. It's not, you cannot mix the -- this is a separate entity itself. So it is -- you cannot transfer the safety and tolerability of one antibody to the other. You can get an idea of what the relative toxicity is, but you cannot transpose it to another antibody. So, therefore, there is a need since the two agents that will be combining to ours [Phonetic] COM701, we know the safety and tolerability of COM701, as you remember, Tony, we started at 0.01 milligrams per kilogram body weight dose and with dose escalated through 20 milligrams per kilogram body weight dose IV Q4 weeks. So, we have a lot of data on COM701. It's an unapproved agent. So, [Indecipherable] it's an antibody that we are still collecting data on, but we are relatively comfortable with what we see in terms of its preliminary anti-tumor activity and safety and tolerability. COM902 is another new agent, it's a TIGIT antibody, but remember that it has never been combined with COM701 which is another unapproved. So we have two unapproved agents. And as far as the regulations go in clinical practice and during conducting clinical trials, you have to be able to compile the safety information of those two agents separately without any other agents in combination, so just be the dual combination. The expectation is because we know what the safety profile of COM701 is very well tolerated, we do not expect to see anything that is out of the blue when we combine with COM902. But at any rate, that's why we are doing the clinical study. So even though the triplet will inform a little bit, it will still not be sufficient to fulfill our regulatory obligations with the combination of COM701 and COM902. I hope that answers your question.

Tony Butler -- Roth Capital Partners -- Analyst

It does, Henry, and thank you for the clarity. And please understand part of the rationale was would you find other information outside of safety, but I think you've made it very, very clear what the goal is and I appreciate it.

Operator

This concludes our Q&A session. I will now turn the call back to Compugen's President and CEO, Dr. Cohen-Dayag. Would you like to make your concluding statements.

Anat Cohen-Dayag -- President and Chief Executive Officer

Yes, thank you. Thank you all for joining the call today. The 2021 is poised to be an important year for Compugen with meaningful milestones and multiple data readouts. We will continue to push forward as leaders in the DNAM axis space advancing our wholly owned PVRIG and TIGIT assets to potentially drive cancer immunotherapy [Phonetic] responses in new and expanded patient population. Thank you for joining us today and your continued support. Stay safe and healthy.

Operator

[Operator Closing Remarks]

Duration: 59 minutes

Call participants:

Anat Cohen-Dayag -- President and Chief Executive Officer

Ari Krashin -- Chief Financial and Operating Officer

Henry Adewoye -- Senior Vice President and Chief Medical Officer

Mark Breidenbach -- Oppenheimer & CO -- Analyst

Stephen Willey -- Stifel -- Analyst

Dana Graybosch -- SVB Leerink -- Analyst

Reni Benjamin -- JMP Securities -- Analyst

Asthika Goonewardene -- Truist Securities -- Analyst

Roger Song -- Jefferies -- Analyst

Tony Butler -- Roth Capital Partners -- Analyst

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