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Compugen Ltd. (NASDAQ:CGEN)
Q4 2020 Earnings Call
Feb 26, 2021, 8:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Ladies and gentlemen, thank you for standing by. Welcome to Compugen's Fourth Quarter and Full-Year 2020 Results Conference Call. [Operator Instructions] An audio webcast of this call is available in the Investors section of Compugen's website, www.cgen.com. [Operator Instructions]

I would now like to introduce Elana Holzman, Compugen's Director of Investor Relations and Corporate Communications. Please go ahead.

Elana Holzman -- Director of Investor Relations and Corporate Communications

Thank you, operator and thank you for joining us today. With me from Compugen are Dr. Anat Cohen-Dayag, President and CEO; Dr. Henry Adewoye, Chief Medical Officer; Ari Krashin, CFO and COO; and Dr. Eran Ophir, VP, Research and Drug Discovery. Anat will provide corporate highlights, after which Henry will review the data we disclosed earlier today, and Ari will review our financial statement and position. Anat, Henry, Ari and Eran will be available for the Q&A session.

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, anticipated progress and the timeline of 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 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 files with the Securities and Exchange Commission, including the company's most recent Annual Report filed on Form 20-F with the Securities and Exchange Commission. The company undertakes no obligation to update projections or forward-looking statements in the future.

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

Anat Cohen-Dayag -- President and Chief Executive Officer

Thank you, Elana. Good morning and good afternoon, everyone, and welcome to our fourth quarter and full-year 2020 corporate and financial update. 2020 was another important year of execution and progress at Compugen in which we strengthened our positioning in the cancer immunotherapy space and solidified our standing as the leader in targeting DNAM axis signaling pathways.

Based on our years of research of this axis, we are executing a strategic and comprehensive clinical development program to evaluate our internally discovered and wholly owned anti-PVRIG and TIGIT assets across settings and combination regimens to elucidate 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 PD-1 pathway. Importantly, our data suggests that these three inhibitory pathways have different dominance in different tumor types and patient populations, which means certain patient populations may require the blockade of different combinations of the three pathways in order to induce effective antitumor immune responses. This is the underlying rationale for our comprehensive clinical program designed to develop new treatment solutions.

Earlier today, we shared data from the combination arm of the Phase 1 dose escalation study of COM701 in combination with Bristol Myers Squibb's nivolumab as well as follow-up on our monotherapy dose escalation study and data from the COM701 monotherapy cohort expansion. While Henry will provide a more detailed review of the data later in the call, I would like to present a high level overview of our data and highlight certain results, which we view as particularly encouraging. We plan to present updated data along with initial correlative data from patient samples at ASCO 2021 to which an abstract was submitted.

Starting with the combination arm dose escalation data, the updated data disclosed today now include complete data from all five dose levels in the study, which we believe are highly encouraging. Overall, we see a disease control rate of approximately 67%, which given the highly refractory nature of this population, is a meaningful accomplishment. We observed durable responses, including the partial response we reported at AACR last year with two patients still remaining on the study since our last data presentation in April 2020 for approximately 10 additional months.

In addition, and most excitingly, one of these two patients, who progressed on an immune checkpoint inhibitor prior to enrolling to our study has converted to a confirmed complete response. Based on this data, we're excited to expand our collaboration with BMS to include a Phase 1b cohort expansion combination study, evaluating COM701 with nivolumab in parallel to our ongoing triplet study. This dual combination expansion study will continue our clinical momentum and will add an additional layer to our clinical strategy, expanding this potentially promising combination regimen as a possible unique and effective treatment opportunity.

It will also provide additional insights to the contribution of the different components of the DNAM axis across our ongoing and future COM701 studies and specifically, our ongoing triplet study. We're also happy that the amendment of our agreement with BMS was revised to include a specific date for the expiration of the exclusivity period, so that it ends at the earlier of six months after the study's completion or on December 31st, 2023. This will ensure termination of exclusivity period in the event that the ongoing dual and triple studies continue beyond their currently expected time frame.

This doublet expansion study is expected to begin in the second quarter of 2021 and will enroll patients with ovarian, breast, endometrial and microsatellite-stable colorectal cancers. Our recent results, including the complete response in a patient, who relapsed on PD-1 therapy increase our confidence that there are certain patient sub-populations, which are likely to respond to a PVRIG PD-1 dual blockade in a clinical setting including those progressed on immune checkpoint blockers.

We also shared initial data from our COM701 monotherapy cohort expansion. While this study was designed as a safety and tolerability study, we used a biomarker informed strategy to select tumor types likely to respond to treatment alone or in combination 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.

In this study of 20 patients for which enrollment was completed in Q4 2020, we had six patients with the best response of stable disease across endometrial, non-small cell lung, and ovarian cancer. We also had durable antitumor activity in two patients on treatment as of the data cut. The combined data of this cohort expansion study with data from previously reported monotherapy dose escalation study that includes a patient with a durable confirmed partial response still on study treatment for more than a year, demonstrate signals of antitumor activity of COM701 treatment in patients with highly refractory disease and in tumor types typically unresponsive to immune checkpoint inhibitors as previously suggested by us. While information from a small monotherapy study may be limited, this data supports the potential role of PVRIG inhibition in patients, who have exhausted all available standard therapies and sets the basis for our next combination studies.

We're now performing correlative assessments based on data from patient samples to gain insights relating to COM701 in the PVRIG, PVRL2 pathway biology, particularly in indications, that are typically not responsive to PD-1. This will allow us to further learn about COM701 activity, as well as to inform our COM701 and COM902 clinical program development path in indications with preliminary encouraging signals of antitumor activity. Our initial assessment of patients' peripheral blood samples suggest that COM701 may enhance immune activation in cancer patients alone or in combination with nivolumab. These initial findings assessing for the first time PVRIG blockade effect in even biological samples are encouraging. Data analysis is still ongoing and is planned to be presented at ASCO 2021 to which an abstract was submitted.

In summary, the data derived from our various studies is an important milestone in our overall clinical strategy, which demonstrate that COM701 and thus PVRIG blockade is presenting signals of antitumor activity in a clinical setting, the conservative basis for our next studies.

The patients enrolled in these studies had diverse tumor types and were treated with various doses of COM701 with or without nivolumab, but the indications in which we observed the responses, as well as the number of highly durable stable diseases, our indications, which are typically PD-L1 low or negative and generally have low response rates to a valuable immune checkpoint inhibitor. Since immunotherapy has been most transformative in PD-L1 positive patients, to see these first signals in indications with such high unmet need that generally do not respond to immune checkpoint inhibitors is encouraging and strengthens our conviction in our approach.

Moving to the next stage of executing our broad clinical strategy, our studies now include our ongoing triplet study of COM701 with nivolumab and BMS TIGIT inhibitor and the planned initiation of both the doublet expansion study of COM701 with nivolumab and a doublet study of COM701 and COM902 later this year. In addition, the comprehensive biomarker assessment from the various cohort expansion studies will provide us insights into the PVRIG PVRL2 pathway biology and shed light on specific contributors to antitumor activity, which may guide us to specific expanded tumor indications. This next phase of our comprehensive clinical program will allow us to quickly generate multiple data readouts and maintain our competitive edge in developing DNAM axis based new cancer immunotherapy treatments.

With our initial supportive clinical data for PVRIG and clinical validation of TIGIT by others, we are excited to witness what we believe is a growing interest in the biopharma industry in both PVRIG and TIGIT, which we discovered independently as new immunotherapy target. We believe that our leadership position in the DNAM axis, our clinical programs, our initial clinical data, and perhaps most importantly, our ability to execute on these broad combination clinical strategy, testing the synergy of these two pathways and in combination with PD-1 places us in a differentiated position in the crowded space of immuno-oncology.

Specifically, we're the only company with wholly owned clinical stage assets targeting both PVRIG and TIGIT, and thus we're the only company capable of evaluating TVRIG monotherapy, dual blockade of PVRIG with PD1 or TIGIT, and triple blockade of PVRIG with PD1 and TIGIT. With our expanded collaboration with BMS, we are rapidly advancing our clinical programs and we believe that we will be the first to generate data which will maintain our position in developing DNAM axis-based new cancer immunotherapy treatments.

Moving next to a brief overview of the status of our ongoing clinical trials and our expected clinical milestones in 2021. Starting with our COM701 monotherapy cohort expansion, additional clinical data and the initial correlative assessments based on data from patient samples collected in our clinical studies are planned to be presented at ASCO 2021. Our recently announced Phase 1b cohort expansion combination study evaluating COM701 with nivolumab is planned to begin during the second quarter of 2021.

Our Phase 1/2 triple combination study evaluating the safety, tolerability, and preliminary antitumor activity of COM701 in combination with BMS TIGIT antibody and nivolumab is currently enrolling patients, and we expect to share initial data from this study in the fourth quarter of 2021. This study rapidly prepares forward the evaluation of our triple-blockade hypothesis, which we believe is an ultimate way to test our hypothesis that blocking the three intersecting pathways has the potential to synergistically enhance antitumor immune responses in selected patient populations, not responsive or refractory to PD-1 blockers alone.

And finally, touching upon our COM902 monotherapy dose escalation study, where there are currently other clinical programs evaluating TIGIT inhibitors, we have always believed 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 include TIGIT in the clinic. COM902 enables us to advance this strategy and our study is currently on track with enrollment. We expect to provide initial data from this study in the fourth quarter of 2021.

Importantly, as we disclosed on our last call, we also intend to begin studies evaluating COM701 in combination with COM902 in the second half of 2021. This study will further expand the breadth of our combination programs, allowing us to evaluate the dual blockade of PVRIG and TIGIT, which we believe may enhance antitumor immune responses in a subset of patients. We look forward to providing additional details on this study in the coming months.

Before we move on, I'd like to briefly touch upon the characteristics and biology that underlies our two clinical assets. As I mentioned earlier, it is our clinical programs combined with our deep scientific expertise and preclinical data that position us as leaders in the DNAM axis immunotherapy space. As a reminder, both COM701 and COM902 were discovered and developed in-house giving us the unique opportunity to rationally design these candidates in ways we believe will position them to be successful in the clinic. There has been a fair amount of scientific debate regarding the role of the isotypes of therapeutic checkpoint antibodies and the function of their respective Fc portions.

Our position has been and remains that an antibody with the sector function carries the risk to deplete CD-8 plus T-cells, which we know are crucial for driving immuno responses in the tumor setting. Because of this, both COM701 and COM902 were developed as IgG4 antibodies, which have reduced Fc effect of function.

So starting with COM701, we know that PVRIG is highly expressed in CD-8 plus T-cells and NK cells and thus we believe moving forward with IgG4 was important to avoid the potential risk of depleting the target cell population which you want to reactivate. Our initial clinical data even in patients with highly refractory disease, who are not expected to respond to checkpoint inhibitors suggest the TVRIG antibody with an IgG4 isotype is active in the clinic. However, it is yet to be demonstrated in the clinic with a potential additional modulatory effects of effector function active antibodies will outweigh possible depletion of CD-8 plus T-cells required for activity.

It is important to highlight that the underlying clinical strategy of choosing IgG1 antibodies is largely driven by preclinical data in mice, where we know the biology of Fc receptors differ significantly from humans. In fact, we have seen multiple examples where this preclinical activity did not translate to the clinic, specifically in the case of both CTLA4 and PD-L1 antibodies for which preclinical activity of antibodies with effector function did not translate clinically.

The story of TIGIT becomes a bit more complicated as opposed to PVRIG. TIGIT and PVRIG are expressed on different cell populations, specifically with TIGIT on Tregs which may be a target for anti-TIGIT depleting antibodies. While there is activity in the clinic with IgG1 antibodies that do have effector function, our hypothesis is that enhancing CD-8 plus T-cell activity not depleting Tregs will ultimately be responsible for driving activity of anti-TIGIT antibodies.

Based on our strong conviction that enhancing CD-8 plus T-cell activity is critical in driving antitumor immune responses, we have advance IgG4 candidates for both PVRIG and TIGIT. We believe this will enable the reactivation of CD-8 plus T-cell function in the tumor setting. However, it is yet to be demonstrated whether such antibodies will prevent superior activity in the clinic.

Next, I'd like to highlight some corporate accomplishments outside of our scientific and clinical progress. In 2020, we continued to invest in our early stage pipeline, which serves as our growth engine. Our early stage pipeline consists of multiple programs targeting the immunosuppressive tumor microenvironment via various mechanisms of action, including myeloid biology. These are early stage programs, but as they progress some may serve as the future of our preclinical and clinical programs. This past year, we were also granted multiple patents to protect our pipeline candidates and we now have composition of matter and use patents protecting COM902 and COM701 in the US, Europe, and other jurisdictions such as COM902 in China, as well as a patent covering the use of anti-PVRIG antibody that activates T-cells and/or NK cells for using treatment of cancer in Europe and other jurisdictions.

We're pleased to announce the first preclinical milestones through our ongoing license agreement with AstraZeneca for the development of bispecific and multi-specific antibodies. As a reminder, we provided an exclusive license to AstraZeneca for the development of bispecific and multi-specific antibody products based on one of our pipeline programs and with AstraZeneca responsible for all research, development, and commercial activities. In connection with these first milestone, we received a $2 million payment from AstraZeneca.

Last quarter, we also updated that Bayer decided to focus on treating IO naive first line head and neck squamous cell carcinoma patients with the combination of BAY 1905254 and Keytruda in the Phase 1 study. This antibody against ILDR2 was licensed by us to Bayer and is targeting the third novel immunotherapy target we discovered computationally. We're proud to partner with three global pharmaceutical companies and believe that the agreements we have in place serve as a validation of the power of our internal discovery and development capabilities. These agreements reflect our strategy of collaborating with biopharma to monetize pipeline candidates, while also advancing drug candidates internally to develop novel cancer immunotherapies.

Finally, before turning the call over to Henry, I would like to very briefly touch upon the ongoing COVID-19 pandemic. As in previous quarters, we are incredibly fortunate to have avoided significant impact on our activities in 2020 with prior guidance for enrollment and data across our studies unchanged. I remain proud of the commitment and dedication showed by our team at Compugen, who together have enabled our continued steady progress throughout this notable year. In addition, we are grateful to our partners, investigators, and shareholders and look forward to continued progress.

And with that. I'll turn the call over to Henry to provide additional details on our recently presented data.

Henry Adewoye -- Senior Vice President and Chief Medical Officer

Thank you, Anat, and good day to everyone. As Anat reviewed this morning, we disclosed data from the combination of COM701 with nivolumab and COM701 monotherapy expansion cohorts. In April 2020, at AACR, we reported data in patients enrolled with dose escalation arms of the ongoing Phase 1 study of COM701 monotherapy, in combination with the nivolumab in patients with advanced solid tumors. This included data from all monotherapy dose escalation cohorts through 20 milligrams per kilogram IV Q4 weeks, and four of the five dose levels from the dual combination dose escalation arm.

We were encouraged we booked the preliminary acceptable safety and tolerability profile and preliminary anti-tumor activity of COM701 monotherapy and in combination with nivolumab. Notably, there were two durable partial responses. One partial response in the combination arm of a patient with colorectal cancer, that's microsatellite-stable with treatments ongoing for more than 10 months. Typically patients with colorectal cancer that has MSS are only responsive to immune checkpoint inhibitors and published data demonstrates a median PFS of approximately eight weeks in this patient population.

We reported another partial response in the monotherapy arm of a patient with primary peritoneal cancer that is also platinum-resistant and with microsatellite-stable status, with treatment ongoing at 24 weeks at the time of the presentation. Overall, we were encouraged with the durability of anti-tumor activity and responses with the number of patients in the combination arm remaining on study for over 200 days.

I can share that there were no reported dose limiting toxicities in dose level five of the dual combination dose escalation arm of COM701, 20 milligrams per kilogram body weight plus nivolumab for 80 milligrams both IV Q4 weeks and there were no new safety findings at this dose. Additionally, the PK profile of COM701 was similar to what we previously reported at the COM701 20 milligrams per kilogram IV Q4 weeks dose in the monotherapy dose escalation cohorts.

Today, we announced the results of all 15 patients, who were enrolled in the combination dose escalation cohorts. Two of the patients had a clinical response of CR or PR, and the disease control rate, i.e., based ten point assessment of -- or better was reported in 10 of 15 patients namely 67%. This preliminary antitumor activity is encouraging considering this is an all-comer heavily pre-treated patient population with a median of five private therapies. In addition, five of 15 patients or 33% had durable response of stable disease of six months or greater.

I would also like to report some additional findings from individual patients in the combination dose escalation arm. Starting first with patients with anal squamous cell carcinoma, with initial assessments of confirmed stable disease at AACR last year for over a year on 0.3 milligrams per kilogram IV Q3 weeks, plus nivolumab 360 milligrams IV Q3 weeks. We are encouraged to share this patient now has confirmed complete response on imaging and is continuing on study treatment at more than eighteen months.

Before enrolling in our ongoing study, this patient received last prior treatment with nivolumab achieving a confirmed complete response and then progressed well on nivolumab. This confirmed complete response following progression on our immune checkpoint inhibitor suggests that treatment with COM701 may broadly target patient population for COM701 therapy. In addition, this complete response, along with the rest of this combination study data also supports our underlying hypothesis that dual inhibition with COM701 and PD-1 inhibitor may offer increased clinical benefit versus monotherapy with our immune checkpoint inhibitor in certain tumor types by inhibiting two parallel non-redundant checkpoint pathways. Specifically, anal squamous cell carcinoma is an orphan cancer and an indication of high unmet medical need for new treatment options.

In addition to this complete response and a previously reported confirmed partial response in a patient with colorectal cancer with microsatellite-stable status, we reported stable disease in eight of 15 patients, 53%. Of note, three patients with durable stable disease, one patient with renal cell carcinoma, who remains on combination treatment at over 13 months. The patients with squamous cell lung cancer with prior with PD-1, PD-L1 and CTLA4 inhibitors, who was on study treatment with COM701 plus nivolumab for over eight months and a patient with endometrial cancer, who was on study treatment over 10 months.

Taking together, this data suggests that COM701 in combination with nivolumab may provide meaningful and durable clinical benefit to patients, including in tumor types typically unresponsive to immune checkpoint inhibitors such as ovarian cancer and colorectal cancer, specifically microsatellite-stable and in patients who have had prior treatment with immune checkpoint inhibitors. These results further support our ongoing combination strategy for the triple combination study and our recently announced dual COM701 plus nivolumab cohort expansion.

Before reviewing the initial data from the monotherapy cohort expansion, I would like to provide additional follow-up data from the monotherapy dose escalation cohorts that we reported at AACR last year. The patients with primary peritoneal cancer, a type of ovarian cancer that is also platinum-resistant and microsatellite-stable status remains and started treatment with confirmed partial response ongoing for more than 14 months. Typically, in this patient population, with standard-of-care treatment with chemotherapy, we reported median PFS or progression free survival is approximately four months, with a reported median overall survival of approximately 12 months.

And patients with pancreatic adenocarcinoma with confirmed stable disease who was on study treatment for seven months, these patients was refractory to all three prior lines of standard-of-care therapies. These data are encouraging, considering that the anti-tumor activity reported with COM701 monotherapy is in a tumor type that is typically unresponsive to the new checkpoint inhibitors, which represents a high unmet medical need for new treatment options and also in efficient refractory to multiple lines of prior therapy. The time on study treatment with COM701 20 milligrams per kilogram IV Q4 weeks in this patient until disease progression is significantly longer than the time on solid treatment for each line of prior therapy that the patient received and was refractory to.

Moving next to preliminary results from the COM701 monotherapy cohort expansion which enrolled a total of 20 patients with advanced solid tumors, including advanced non-small cell lung cancer, ovarian, breast, endometrial, and colorectal cancer, who have exhausted all available standard therapies. The key objective of the study was to evaluate the safety and tolerability of COM701 at the recommended dose for expansion of COM701, that is 20 milligrams per kg IV Q4 weeks. And additional exploratory objective is the preliminary evaluation of the antitumor activity of COM701 monotherapy at the recommended dose for expansion.

I can report that six of 20 patients or 30% of the patients had best assessment of stable disease with one patient with endometrial cancer, three patients with non-small cell lung cancer, and two patients with ovarian cancer. Two patients with stable disease remain on study as of the data cut of December 14th, 2020. One patient with non-small cell lung cancer, with treatment ongoing at six months and a patient with ovarian cancer with treatment ongoing at 20-weeks.

Particularly noteworthy is the patients with non-small cell lung cancer, who remains on treatment and have received more than three prior lines of therapy including prior immune checkpoint inhibitors. Two additional patients, who are still on the study have not reached their first assessment at the time of the data cuts. 12 patients have stopped study treatment with the majority due to progressive disease. There were no new safety findings at this dose. Overall, the disease control rate in the monotherapy dose escalation and expansion cohort was 47% with best responses of durable anti-tumor activity including a partial response. Further analysis of this study data is ongoing.

As Anat mentioned, we are now performing correlative study patient samples including preliminary assessment of blood cytokines and immunophenotyping with the objective of complementing our research on how COM701 modulates the tumor microenvironment, particularly in indications that are typically not responsive to PD-1 to further learn about COM701 activity, which will inform on additional studies to be conducted in indications with preliminary encouraging signals of anti-tumor activity.

As Anat indicated, our initial assessments of patients' peripheral blood samples suggests that COM701 may enhance immune activations in terms of patients alone or in combination with nivolumab. Initial data from these assessments along with updated data are planned to be presented at ASCO 2021 for which an abstract has been submitted.

In conclusion, in the ongoing patient study evaluating COM701 monotherapy and in combination with nivolumab, we have now reported encouraging signals of anti-tumor activity in patients that are heavily pretreated, in patient who have received prior immune checkpoint treatment, in patients refractory to prior treatment and in tumor types typically unresponsive to immune checkpoint inhibitors. This signals of anti-tumor activity across our studies include stable disease, including durable stable disease, confirmed partial responses, and confirmed complete response in diverse tumor types such as primary peritoneal cancer/ovarian cancer, anal squamous cell cancer, endometrial cancer, non-small cell lung cancer, pancreatic cancer, colorectal cancer that is microsatellite-stable status, renal cell cancer and adenoid cystic cancer and cervical cancer.

For the most part, this will answer the questions that at this stage of the study we have demonstrated that COM701 monotherapy and in combination with nivolumab has an acceptable safety and tolerability profile. Additionally, at this stage, we have preliminary evidence of anti-tumor activity. We will continue to test our hypothesis that driving robust immune responses will require combinatory blockade of PVRIG with PD-1, TIGIT, or all three together and we are still advancing clinical programs that explore each of these combinations.

Following the evaluation of correlative assessments based on data from the patient samples collected in our study's expansion cohorts, the next steps may include the selection of target indications for additional studies, including combinations with standard-of-care agents. We look forward to continued progress in our triple combination Phase 1/2 open label study, which is evaluating the safety, tolerability, and preliminary anti-tumor activity of COM701 in combination with nivolumab and Bristol Myers Squibb's anti-TIGIT antibody in selected tumor types, mainly ovarian cancer, endometrial cancer, as well as a biomarker driven arm of tumor types with high expression of PVRL2.

Additionally, in order to maintain our leadership position and independence to evaluate various combination regimens, we also have continued to advance our Phase 1 dose escalation trial of COM902 and look forward to advancing the clinical program for our fully owned TIGIT blocker also in a combination study with COM701, whereby evaluating the PD-1/PD-L1 free regimen.

And finally, before turning the call over to Ari, I would like to express my gratitude that the Compugen team, our investigators and of course, our patients and families who have played integral roles as we advance our clinical programs to expand into new immuno therapies. Thank you.

Ari Krashin -- Chief Financial and Operating Officer

Thank you, Henry. Good morning and good afternoon to everyone. Our financial results for the fourth quarter and the full-year of 2020 released this morning reflect the continued expenses associated with our ongoing various clinical programs. Our revenue for the fourth quarter and full-year of 2020 were $2 million, representing the first development milestone from our license agreement with AstraZeneca announced during the fourth quarter.

Research and development expenses during the full-year of 2020 were $22.8 million, an increase of approximately 15%, compared with $19.8 million in 2019. For the fourth quarter of 2020, research and development expenses were $8.1 million, an increase of 88%, compared with $4.3 million in the prior year period of 2019.

The increase in both cases is attributed mostly to higher clinical studies, related expenses, as well as CMC related activities, specifically manufacturing for additional drug supply of both COM701 and COM902 to support the planned expansion of our various clinical trials.

Net loss for the full-year of 2020 was $29.7 million or $0.37 per basic and diluted share, compared with a net loss of $27.3 million or $0.43 per basic and diluted share for 2019. Net loss for the fourth quarter of 2020 was $8.6 million or $0.10 per basic and diluted share, compared with a net loss of $6.5 million or $0.10 per basic and diluted share for the prior year period.

As of December 31st, 2020, we had approximately $124 million in cash and cash-related accounts, compared with approximately $44 million at the end of the prior year. We have no debt. The increase in our cash balances is mostly attributed to approximately $74 million of net proceeds received in our public offering last March, approximately $18 million received from exercise of warrants and approximately $16 million received from exercise of employee options offset by operating expenses and working capital of approximately $28 million.

Going into 2021, we expect to have gross cash expenditures 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 collaboration.

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 Chris Howerton of Jefferies. Please go ahead.

Chris Howerton -- Jefferies -- Analyst

Hey, good morning, and thanks for taking the questions. So, I guess, first of all, obviously great to see another complete response. But I guess, I am curious about the monotherapies arms, what, at least by your eyes, the expansion cohort seem to have at least flatter or slightly less efficacy. So, I am curious to see Henry or Anat what your explanations might be in terms of what could explain the differences between those two patient populations or subjects in those two different study arms? So, that's one question.

The second question would be, with respect to the CR it's such a low dosage of 0.3 mg, what do you think is going on there? And then I guess that is kind of tacking on to my third question, which is how -- could you give us a little more color on kind of the biomarker strategy? And how is it that you are going to try and elucidate what is it, like prospectively, what are the tumor types or patients that could respond to mono, double or triple therapies? Thank you.

Anat Cohen-Dayag -- President and Chief Executive Officer

Sure. Hi, Chris. And I'll start by just a few remarks and then I'll turn to Henry answer the questions. But I think that in general for the monotherapy, we are trying not to compare it to portions of the studies with different patients, etc, we look at the totality of the data and the directionality of the data that we generated, the dose escalation, as well as the monotherapy expansion. I'll let Henry related to the CR and then we'll get back to the biomarker strategy. Henry?

Henry Adewoye -- Senior Vice President and Chief Medical Officer

Yes. Thank you very much, Anat. And thank you very much for your questions, Chris. Yes, we looked at the data also, but the key takeaway from what I would like to say here is that, the two different ways to look at this data and you'll come to the same conclusion and the conclusion you'll come to is there is preliminary antitumor activity with COM701 monotherapy and also in combination with nivolumab.

And if you were to look at the dose escalation cohorts, the objective of that of the study was just to establish what the safety and tolerability profile and DLTs with COM701 starting at a very low dose. For the expansion cohort, the primary objective of this cohort was simply to establish what the safety and tolerability of COM701 is at the recommended dose for expansion which is 20 mg per kilogram body weight IV Q four weeks. So we've been able to demonstrate this from what we've been able to show and therefore that's the only assessment one should be able to take from it. And in addition remember that in patients who are also on therapy on the COM701 20 mg per kilogram body weight dose, we have highlighted that at least a third of those patients, right, six out of the 20 have stable disease during the course of the -- in my prepared remarks.

So, that's the way we will look at it and it will be very, very difficult to start comparing dose escalation with DLTs as an endpoints with safety and tolerability in the expansion cohorts, even though you do still see the same antitumor activity for both. Right. So, let me go to the second question with the confirmed complete response. Yes, so, remember, Chris, that we presented data at SITC with regards to receptor occupancy for COM701 and in that data, we said that the dose, the absolute bottom at 75% receptor occupancy of rituximab 0.3 and above one you have 90% or higher. So we think that possibly a reason for this, it takes a while in addition that is multiply treated with several prior lines of therapy for actually -- for COM701 to possibly inhibit the activity of all the cancer cells within the tumor itself.

So that's one reason that possibility and that -- for one takes such a long time in this patient. But the ultimate thing for that patient, remember, Chris, is that, the complete response was observed again after relapse while on nivolumab. I think that's the key thing here. So the biomarker strategy, I am sure and I should probably want to continue with this, but what we intend to do is to evaluate in patients in the expansion cohort pre samples that were obtained before study treatment and samples obtained during the course of study treatment in terms of the biomarkers are injected primarily through PD-IL2 to be able to see the -- any correlation, we've already presented preliminary -- we've looked at preliminary data in terms of the cytokines in the blood to see if there is any correlation with some of the antitumor activity that we've observed and you have seen that in my prepared remarks. So, I'll just stop there and see if that answers your question or if you have additional comments.

Chris Howerton -- Jefferies -- Analyst

Yes. No. That's really helpful. And then, so, I guess, with respect to the CR, basically the -- I mean, my assumption with respect to the biology is there was obviously some escape with respect to nivolumab's mechanism of action and that the 75% receptor occupancy you feel is enough to get the blockade of the rest of the pathway, I guess, is kind of the message you are saying, Henry?

Henry Adewoye -- Senior Vice President and Chief Medical Officer

Yes. But remember, the receptor occupancy I'm talking about is peripheral, it's not within the tumor.

Chris Howerton -- Jefferies -- Analyst

Yes. That's [Speech Overlap]

Henry Adewoye -- Senior Vice President and Chief Medical Officer

And therefore -- yes. And therefore, Chris, remember again that the reason we went as high as the dose that was selected is because of the patient population that we intend to explore. That's one. And then, number two, one of the patients, I think, 20 milligrams per kilogram body weight dose, that's the patient that has a tumor type that is typically unresponsive to immune checkpoints. That's the patient with primary peritoneal cancer.

At the very first assessment for that patient, the patient had the partial response. We presented that patient's data and images that were captured by the investigator at AACR last year. So the partial response actually deepened with 20 milligrams per kilogram body weight dose and that patient has held onto that response for more than a year now. So, it shows that you -- probably within the tumor cell and especially in patients who have been treated previously with maybe immune checkpoints or several lines of chemotherapy, you need to achieve sufficient penetration into the tumor itself.

The other patient I would like to bring up also that is also peritoneal -- the patient with microsatellite-stable colorectal cancer. It's the same thing that we observed in that patient. Remember that was patient that we presented also at AACR. And for that patient -- that patient had four prior lines of treatment and they were on COM701 on the combination with nivo at -- nivo was 360 milligrams IV Q3 weeks and COM701 was 0.3 milligrams per kilogram body weight dose. That patient was on study treatment and confirmed stable disease up until about seven months before they then had a PR partial response that then was confirmed several times afterwards. So that's the totality and the interpretation of that data.

Chris Howerton -- Jefferies -- Analyst

Yes. Okay. All right. That's great. I don't know, Anat, if you wanted to add anything to Henry's comments with respect to the biomarker strategy, but I appreciate the response.

Anat Cohen-Dayag -- President and Chief Executive Officer

Yes, sure. Yes, I'll just add. I'll let Eran relate to the biomarker strategy, but I'll just say that just in terms of looking at the totality of the data and that will be of the monotherapy and that will be a segue to the biomarker discussion. We also stated that we see immune activation in our initial correlative assessments in that sample. And that's in the single agent and also in combination. In a single, when you look at the story of what the antitumor activity, when you look at the totality of the data as well as the fact that there was immune activation, any different tumor types and durable antitumor activity, for us it serves as the basis in order to take it to the next stage.

We think that the data points to the fact that COM701 is active. We will continue to look at the monotherapy setting, the patient is still on study. We'll continue to do some additional correlation studies, additional biomarker work, Eran will relate to it. And we'll make the decisions with respect to monotherapy, specifically as we have the full data. But now, it serves us well in order to move forward into the combinations and to expand our strategy for combination treatment.

So, Eran, would you like to relate to the biomarker?

Eran Ophir -- Vice President, Research and Drug Discovery

Yes. So, as Henry mentioned, we are looking at pre and post samples. We're looking at the expression of the DNAM axis, try to correlate response with the expression of the axis. We're looking at the immunomodulatory activity of COM701. We do that by looking at peripheral blood and we already stated today that you see that COM701 probably enhances immunity in patients, which is very important to see. And there we are also going to look in tumor microenvironment with different sequences, methods to try to see a modulation of tumor microenvironment in addition to what we've already seen in peripheral blood by COM701 but that will try to link all of it with response and indication and patient selection.

Chris Howerton -- Jefferies -- Analyst

Got it. Okay. And the pre, post biopsy analysis particularly for the DNAM axis, is that anticipated to be at ASCO this year around?

Anat Cohen-Dayag -- President and Chief Executive Officer

At this stage, we stated that initial correlative assessments will be presented -- in general will be presented at ASCO. If we are accepted -- we didn't give guidance yet to the DNAM axis biomarkers, the immunohistochemistry. This is work-in-progress and we'll for sure share the data, but we didn't give guidance yet.

Chris Howerton -- Jefferies -- Analyst

Okay. Wonderful to see the progress. And again, thank you very much for taking the questions and your answers.

Anat Cohen-Dayag -- President and Chief Executive Officer

Thank you.

Operator

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

Stephen Willey -- Stifel -- Analyst

Yes, good morning. Thanks for taking the question. And I was jumping around a bit. So forgive me if I ask something that was already discussed. But can you maybe just provide a little bit more color around the kinetics of the CR patient in the doublet cohort? How long was that patient confirmed to have stable disease before they flipped to a CR?

And I guess I ask the question because I know that there is three other patients who are still in the midst of confirmed stable disease for some pretty long durations. And I'm just trying to get sense as to whether or not those patients could also become responders at some point based upon the kinetics of the CR that was observed.

Anat Cohen-Dayag -- President and Chief Executive Officer

Henry, I guess you will take it?

Henry Adewoye -- Senior Vice President and Chief Medical Officer

Yes, I will. Hi, Steve. So, the patients with the confirmed complete response with anal squamous cell carcinoma was on study treatment for nine months until we observed the complete response. And I've been saying that the complete response, like I mentioned, has not been confirmed repeatedly.

Stephen Willey -- Stifel -- Analyst

Okay. And for those remaining patients that are on -- that are still in the midst of a confirmed stable disease, I guess, for six-plus months, are those patients also at a 20 mg per kg dose? Have you been able to dose escalate those patients as you cleared in various dose levels or have you kept those patients at their pre-specified dose level?

Eran Ophir -- Vice President, Research and Drug Discovery

Yes. So, for those patients who were at the dose escalation for both the monotherapy and for the combination dose escalation, with the exception of maybe the first two dose cohorts, there was no subject dose escalation. So they will remain at the doses that they are on, if they are still on the study. So, for example, the patients that is at the 20 milligrams per kilogram body weight dose with pancreatic cancer, which we have, the investigation that's ongoing at that dose, in the dose in arm A, that patient will remain at that dose, so we can collect safety and tolerability. But the previous data we disclosed, we didn't have any dose intrasubject dose escalation but for one patient, which was at a very, very low dose at that point.

Stephen Willey -- Stifel -- Analyst

Okay. And then, have you mentioned or can you discuss at this point, I guess, how many patients you're intending to enroll within each of the doublet dose expansion cohorts? Should we anticipate that this is going to be kind of like monotherapy dose expansion where you had a small number of patients over kind of a fairly heterogeneous spectrum of tumor types or should we expect more patient numbers to be represented by each tumor type?

Anat Cohen-Dayag -- President and Chief Executive Officer

So we did say -- go ahead, Henry.

Henry Adewoye -- Senior Vice President and Chief Medical Officer

Yes. So, if you go on clinical trials with government, do you say that [Phonetic] for the expansion cohort, the dual combination, we're going to have more patients. So, remember, for the monotherapy expansion, we really had four patients per tumor types, we had five tumor types: lung, ovarian, breast, endometrial and colorectal which is microsatellite-stable colorectal. For the expansion cohort, for the dual combination, we'll have more patients, up to about 20 patients in each of the tumor types that are of interest to us.

Stephen Willey -- Stifel -- Analyst

Okay. So you have up to 20 patients on a per tumor type basis?

Henry Adewoye -- Senior Vice President and Chief Medical Officer

That is correct.

Stephen Willey -- Stifel -- Analyst

Okay. And then, I believe there is plans also to look at COM701 with COM902. I guess, is that a correct assumption and in pursuing that dose escalation, would you be specifying tumor types of interest to serve as the basis of an initial trial there?

Anat Cohen-Dayag -- President and Chief Executive Officer

Henry?

Henry Adewoye -- Senior Vice President and Chief Medical Officer

Yes, Stephen. Yes, you can see how compelling that strategy is because now that we've shown preliminary anti-tumor activity of COM701 alone in patients who are refractory to standard of care therapies, including the new checkpoints and also in combination with nivo in patients who have relapsed following nivo therapy, you can see that we will be interested in testing a strategy a regimen that is PD-1 or PD-L1 free, just based on the hypothesis that we have. So we haven't eliminated the tumor types yet, but it will be in tumor types that we think will have the high probability of having activity with the inhibition of the two non-redundant parallel pathways.

Anat Cohen-Dayag -- President and Chief Executive Officer

And Steve, we'll initiate this study. The study is expected to be initiated in the second half of this year.

Stephen Willey -- Stifel -- Analyst

Wonderful. Thank you for taking the questions. And congratulations on the progress.

Anat Cohen-Dayag -- President and Chief Executive Officer

Thank you.

Operator

The next question is from Mark Breidenbach of Oppenheimer. Please go ahead.

Mark Breidenbach -- Oppenheimer -- Analyst

Hey. Thanks for taking my questions. And congrats on the very encouraging clinical update. This might be a little bit of a rephrasing of one of the questions that was earlier in the queue. But I'm trying to get a sense for if you have any predictions about specific biomarkers that might indicate cases where the doublet combination might be more suitable than the triplet combination. And I'm also wondering if the doublet expansion cohorts will test -- will include non-small cell lung cancer, which I believe is being included in the triplet study?

Anat Cohen-Dayag -- President and Chief Executive Officer

So, I'll start but then I'll let Eran. I'll just say that in general, you were looking from the indications perspective. But in general, from our perspective, the triplet study is the ultimate way for us to test our hypothesis. But now being in the situation that we're the first to move ahead with the PVRIG and now with the data that we have and some initial data supporting the hypothesis for us now is the time to move ahead and broaden the clinical strategy and test all the different combinations that are relevant out of these three pathways story.

So we think, based on our data and Eran will relate it to it, that different patient populations, with different dominance of these pathways may respond differently, but it is also important for us to have some overlapping indications. And this is in order to be able to do some biomarker work and better understand the biology of the PVRIG access, the contribution of the components, how the different patient subsets are responding. So, I think that when you think about the strategy and you think about the different combinations, an array of combinations that we're going to execute and about the different indications, we're also rationally designing how we're going to collect the information out of this patient population and make eventually decisions about specific subsets that would fit different combinations.

So with that, I'll let Eran discuss specifically the doublet versus triplet translational data.

Eran Ophir -- Vice President, Research and Drug Discovery

Yes. So basically all the three pathways has multiple approach to look them. We have the ligands, we have the receptors, we have the expression, but different cell types for each of those. And at the end of the day, we do identify some indications and even inside the specific indications, some patients which have different dominance across cell types of different pathways. And yes, there could be patients in which the PD-1 and PVRIG pathways are more dominant and we expect to see more dominant response in these patients even in the absence of TIGIT blockades.

So when you look at this in the trial, when you look also at biomarkers, the DNAM axis, etc. And so again, to formulate, if we see any responses specifically in this patient that we anticipated response even in the absence of TIGIT blockade.

Mark Breidenbach -- Oppenheimer -- Analyst

Okay. That's helpful. Just another question related to kinetics response maybe for Henry. Just can you remind us what the average time to response has been across the various cohorts, combination or monotherapy cohorts that you've seen responses in, excluding the one complete response that developed at nine months in? Thanks.

Henry Adewoye -- Senior Vice President and Chief Medical Officer

Yes. So, Mark, like I said, the complete response, the patient with anal squamous cell carcinoma was nine months in until we observed the first complete response. The patient with colorectal cancer microsatellite-stable was seven months immune until we saw the first partial response in that patient. Remember, the doses here is 0.3 milligrams per kilogram body weight and 360 milligrams IV Q3 weeks of nivolumab.

For the patients with primary peritoneal cancer on the monotherapy arm, the partial response was observed at the very first imaging assessment, which was at eight weeks. So you can see that -- that's why I mentioned previously that perhaps it takes much longer in a patient population that is multiply treated, for there to the penetration into the tumor itself and that's where we probably observe that partial response at the very first at the outset with the patient with primary peritoneal cancer and a detail of that exactly also [Phonetic]. So those are ones we've seen.

For the patients with stable disease, it's obviously at the very first disease assessment and for those who have confirmed stable disease, that stable disease just shows if you look at the patients with target lesions, continuous stabilization in most of these patients. And that's all I can say at this point.

Mark Breidenbach -- Oppenheimer -- Analyst

Okay. Fair enough. That's very helpful.

Anat Cohen-Dayag -- President and Chief Executive Officer

I'll just add for everyone that the corporate presentation is updated with few slides describing this clinical data.

Mark Breidenbach -- Oppenheimer -- Analyst

Okay. Terrific. Thanks so much for taking my questions.

Operator

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

Reni Benjamin -- JMP Securities -- Analyst

Hey. Good morning, guys. Thanks for taking the questions and congrats on the update. Maybe just a couple of questions. One, can you just comment on what the median duration of responses across maybe the monotherapy and the combination studies are separately? Also, is there any way outside of the biomarker data to try to narrow down the indications to focus on? I guess I'm trying to get a sense as to how you might be thinking about a registration strategy going forward. And you mentioned other combinations outside of COM701 plus Opdivo, wanted to just get your thoughts on what sort of combinations you might be thinking about and when you might start those?

Anat Cohen-Dayag -- President and Chief Executive Officer

Henry, I guess you will take this one?

Henry Adewoye -- Senior Vice President and Chief Medical Officer

Yes, I'll take the first one. Hi, Reni. Thank you for your question. Yes. So with respect to the median duration of response, we actually haven't even reached a median -- I mean, it's still ongoing, because none of the patients, with the exception of the patients with microsatellite-stable colorectal cancer that was on for 44 weeks, right, the other two patients are ongoing. So, statistically the only way to interpret that kind of data is just to say that it is still not estimable in terms of what the median will be, because we have one patient that's been solid treatment now with the complete-complete response -- with the confirmed complete response that's ongoing for 18 months. And then we have the other patients with primary peritoneal cancer that's ongoing now for 14 months.

So, you're going to see that because of the data, it's heavily skewed toward the patients that are ongoing. It is still too early to know what the median duration of the response will be. However, what one can see from this data is, it's going to be much longer. It looks like it's going to be much longer than at least a year. So that's just the preliminary way to look at that in terms of the responders on the study, all right.

And then, Reni, the other question you asked was, what is our thinking with regards to biomarkers for the indications. That is something that really Anat and I will probably contribute a little too. We will look at what's the expression of this candidate biomarkers are to see if there is any correlation and that will then guide, based on that, what's the tumor types, whether it's going to be a basket trial or other kind of innovative trial.

With respect to my comments on additional testing outside of its new checkpoint, I think that's a valid way to look at in totality of the safety, the preliminary safety and tolerability profile of COM701. It's tolerable at the doses that we've gone as high as 20 milligrams per kilogram body weight IV Q4 weeks. It is tolerable at that dose with nivo at standard doses for 80 milligrams IV Q4 weeks. I think, I don't foresee if we combined, for example, with standard of care therapies in any of the tumor types that we've enumerated any safety findings. So it's still an open question with regards to what those combinations will be and what these tumor types will be.

And once we get full information, Anat would be able to provide that to you.

Anat Cohen-Dayag -- President and Chief Executive Officer

Right. Yes. I think that just in terms of the -- we're now focusing on the combinations in specific indications and this is why there is some overlap between the indications. We want to make sure that we covered these indications that were raised by our DNAM axis hypothesis and the translational data. But obviously focusing on specific indications and taking a path to registrational is also something in our mind. And as Henry said, as we move forward, when we formulate this at path forward, we'll share it with the investors.

Reni Benjamin -- JMP Securities -- Analyst

Okay. And just as a follow-up, we tend to do biomarker analysis and quite a bit of analysis on the patients that are responding. Any work that you guys are doing on the patients that aren't responding and any learnings that you're obtaining from those that are not responding that you might be able to utilize as an exclusion criteria?

Eran Ophir -- Vice President, Research and Drug Discovery

Yes. So we're looking obviously at all the patients. Actually it's very important, as you mentioned, to look also in non-responding patients. And we are correlating all parameters from -- again, from within all the analysis to all the patients and for all the samples that we have to enforce this. And we're going to correlate biomarkers to response. And of course, we're going to also identify the non-responder population, try to understand which patient we should not treat.

Reni Benjamin -- JMP Securities -- Analyst

Got it. Thanks for taking the questions.

Operator

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

Asthika Goonewardene -- Truist Securities -- Analyst

Hi. Good afternoon, guys. And congrats on the updates that you provided in the call today. Really exciting to see that. I just wanted -- maybe just another rephrasing of the previous question, but maybe asked in a different way here. Could you discuss the translational data that gave you the confidence that the doublet COM701-Opdivo has sufficient activity in breast, ovarian, endometrial and CRC. I'm specifically wondering what is it that you saw in the data that made you pull the trigger? I've got a couple of follow-ups after that.

Eran Ophir -- Vice President, Research and Drug Discovery

So, in terms of translational data, what we start to see is that COM701 is probably inducing enhanced immunity in this regard in the peripheral blood. You can see increase in cytokines, T-cell proliferation, etc, indicating activity. You can see this is in monotherapy, which is of course very important to relate the activity to COM701 itself. We also see this in the combination. Again, the COM701 in combination with Opdivo can enhance immune activity. And taking this with the clinical data and the clinical response that we've seen in the doublet specifically, probably all of this together is strongly hinting for a signal in doublets but should further be explored in clinical studies.

Asthika Goonewardene -- Truist Securities -- Analyst

Got it. Thank you, Eran. And then, maybe to Henry, in the expansion study in the tumor types, I know that the details are going to be hopefully at ASCO, but I just wonder if you could entertain us here. How many of these FTEs were in PD-L1 low or PD-L1 negative tumors? Can you just maybe give us some sort of a sense to that? And perhaps if any of them were -- and if the three non-small cell lung cancer patients were PD-L1 low and negative too?

Henry Adewoye -- Senior Vice President and Chief Medical Officer

Yes. Yes, we will provide that data at ASCO. But I think the key takeaway -- so I will not be able to disclose to you now what the analysis in terms of the breakdown with the number of prior therapies, the PD-1, PD-L1 percentage is and in terms of patients with refractory diseases and so on. This breakdown we will provide in the subsequent release when we update the data.

I think what is exciting for us is that, especially in the patient population that we enrolled on this study in the monotherapy expansion, these are patients who have exhausted all available standard of care therapies. So it's not like a first-line or second-line, they're just at everything in terms of what the eligibility we have in the protocol. Now, it's also important to note that, like I mentioned, of the 20 patients that we have, six have at least stable disease at the time of doing this presentation. So, the breakdown, we will provide when we update the data.

Asthika Goonewardene -- Truist Securities -- Analyst

Got it. And then, lastly, I was wondering if you could maybe tell us a little bit about when we could see more on your myeloid program and maybe other new applications of your discovery platform. Thanks a lot.

Anat Cohen-Dayag -- President and Chief Executive Officer

Sure. So, first, I'll just make sure that everyone also heard the fact that we are anticipating to disclose additional data also beyond ASCO for the triplet dose escalation in Q4 and also for our COM902 program in Q4. With respect to the myeloid programs as well as discovery capabilities, we didn't give any guidance. The guidance is the following for the myeloid programs. And for the other programs in our early stage pipeline, it's not only including myeloid. But we would like -- these are novel programs -- we would like to have the science deepen in a way that we can push this program forward and know that we have a path to the clinic and that we can protect these programs also business-wise. And that's what's directing our decisions when and what we're going to disclose. So, we did -- I know that this is of interest to investors and we will share data as soon as we will get to this point that I just defined.

For the computational discovery capabilities, I can only say that we continue to enhance these capabilities. Obviously there is a huge interest in the computational biology field in the industry. We continue to enhance our capabilities in order to continue to feed our own pipeline. And usually we're not sharing data with respect to new drug targets that we discover at this point in time. So I think that only sharing the type of platforms that we discover, etc, but I guess that with respect to new drug targets that we discovered, that will need to be -- remain undisclosed from a corporate strategy.

Asthika Goonewardene -- Truist Securities -- Analyst

Thank you very much guys.

Anat Cohen-Dayag -- President and Chief Executive Officer

Thank you.

Operator

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

Tony Butler -- ROTH Capital -- Analyst

Thanks very much. Just three brief questions, if I may. Number one is, when you combine COM701 and/or nivo with COM902, COM902 -- when you -- in the future do that, COM902 as you've laid out is dosed Q3 and obviously the other two could be dosed Q4. So I'm curious how you think about that if at all today.

Number two is, you've made comments about some tumor types, including breast, which I assume is HER2 negative breast, but what's interesting I think is that COM701 has activity obviously -- or has been demonstrated in PD-L1 low, PD-L1 negative cohorts. It's interesting to note that certain triple-negative breast that only PD-1 can be utilized in PD-L1 high. So I was just curious if you've given any thought about TNBC because in combination you may have some real nice responses certainly in PD-L1 negative patients. And then finally, when you present data at -- or when data are presented later at ASCO, have you considered having a call or a meeting in conjunction with those data to perhaps expand on the total presentation? Thanks very much.

Anat Cohen-Dayag -- President and Chief Executive Officer

Thank you. With respect to ASCO, obviously we first need to be accepted and we'll see how we present data as part of the ASCO. So that still remains to be -- first need to be accepted. With respect to the breast -- question with respect to breast or triple-negative breast, I will just let Henry address it. Henry?

Henry Adewoye -- Senior Vice President and Chief Medical Officer

Thank you very much, Anat. Yes, thank you so much, Anat. I was on mute. Yes, patients who have triple-negative breast cancer are eligible for enrollment on to this study. So it's open to them. And I'm aware -- we are all aware of the data with the PD-1 and PD-L1 inhibitors in this patient population. So that patients are eligible for enrollment on to the study.

Yes, the other question you asked had to do with the dosing strategy in terms of the PK. So, I'll just take you back a little bit, so we have looked at COM701 and this data is already released at both AACR most recently last year, on looking at Q3 dosing and Q4 dosing for COM701. And we're able to dose COM701 at any of these Q3 weeks or Q4 weeks. For now, the dosing for COM902 is Q3 weeks, but obviously, we will look to see, as we accumulate more data, whether dosing can be spaced out to Q4 or any other dosing strategy. And this results -- and what we will do will be based on what the PK data actually shows, which we will obtain and then be able to dose. But having said that, do recall that, even if there is a difference in terms of dosing Q3 weeks, Q4 for any of the therapies, you can still do evaluation for -- during dose escalation, even if the dosing doesn't match. You can see many regimens with chemotherapy or even with some of the new checkpoints where they combine with other agents to employ that strategy. But yes, it is a little bit more convenient for patients if we choose two or more agents I administrate [Phonetic] have the same schedule in terms of IV dosing.

Tony Butler -- ROTH Capital -- Analyst

Henry, thank you very much and I appreciate it.

Operator

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

Anat Cohen-Dayag -- President and Chief Executive Officer

Yes, thank you. We are enthusiastic by the steady progress and execution across multiple clinical programs, which we believe solidifies Compugen as the leader in DNAM axis immunotherapy. We're excited by the COM701 data we disclosed earlier today, which reinforced our conviction with respect to our clinical development strategy. We look forward to expanding our clinical program to explore additional combination regimens as well as important data readouts across our ongoing clinical programs evaluating the single, dual and triple blockade of DNAM axis members.

2021 is expected to provide meaningful insights into the underlying biology and potentially further substantiating the clinical relevance of this axis. And with our wholly owned PVRIG and TIGIT assets, we're uniquely capable of developing potentially transformative cancer immunotherapies. Thank you for joining us today and your continued support. Stay safe and healthy.

Operator

[Operator Closing Remarks]

Duration: 83 minutes

Call participants:

Elana Holzman -- Director of Investor Relations and Corporate Communications

Anat Cohen-Dayag -- President and Chief Executive Officer

Henry Adewoye -- Senior Vice President and Chief Medical Officer

Ari Krashin -- Chief Financial and Operating Officer

Eran Ophir -- Vice President, Research and Drug Discovery

Chris Howerton -- Jefferies -- Analyst

Stephen Willey -- Stifel -- Analyst

Mark Breidenbach -- Oppenheimer -- Analyst

Reni Benjamin -- JMP Securities -- Analyst

Asthika Goonewardene -- Truist Securities -- Analyst

Tony Butler -- ROTH Capital -- Analyst

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