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Compugen Ltd. (CGEN 1.06%)
Q1Â 2020 Earnings Call
May 6, 2020, 8:30 a.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 First Quarter 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, 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; and Ari Krashin, CFO and COO. 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 and other forward-looking statements regarding future events, or future business outlook, our development efforts and their outcome, our discovery platform, anticipated progress and time line for our programs, financing 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 filed with the Securities and Exchange Commission, including the Company's most recent Annual Report on Form 20-F filed on February 24th, 2020. The company undertakes no obligation to update projections and 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 first quarter 2020 corporate and financial update. As Elana mentioned, today on the call, I have with me Dr. Henry Adewoye, our Chief Medical Officer, who will provide updates on our clinical progress. We also have Ari Krashin, our CFO and COO, who will review our financial statements and position.
In the past two months, we have experienced a new reality brought about by the COVID-19 pandemic, which impacted every aspects of our lives, both private and professional. Our highest priority during these times has been, and continues to be the safety and health of our employees, while doing our best to meet our goals. Most of our employees are currently working remotely, though, almost all of our lab scientists continue to work in our R&D laboratory under strict safety guidelines.
We have reviewed our most critical activities and implemented mitigation plans to minimize the impact on our clinical programs, which I will discuss in more detail shortly, as well as our early stage pipeline program. Simultaneously, we're preparing for escalating scenarios nationwide or Company wide. We're now implementing measures which are intended to allow for smooth and efficient recovery once normalization is declared. At this time, we're not experiencing significant delays in our plans, and despite the ongoing challenges associated with the COVID-19 global pandemic, the first quarter of 2020 has been one of significant and continued accomplishment for Compugen.
We reported additional encouraging data from our Phase 1 COM701 dose escalation study, both as monotherapy and in combination with Opdivo. These further support the potential of our overall science-driven clinical strategy. In addition, we have advanced COM902, our anti-TIGIT antibody to the clinic, announcing the first patient dose in April. This marks a third target program discovered computationally by us that is now in clinical studies.
Earlier in the quarter, we also announced an important strategic step by extending our ongoing collaboration with Bristol-Myers Squibb to include a Phase 1/2 triple combination study testing COM701 with BMS Opdivo and their investigational TIGIT inhibitor. This study will enable us to directly test our hypothesis of an intersection between the PVRIG, TIGIT and PD-1 pathways in which the simultaneous blockade of these three pathways has the potential to synergistically enhance anti-tumor immune response in selected patient population not responsive or refractory to PD-1 blockers alone.
As a brief reminder, our internal discoveries on the existence of two parallel and complementary pathways in the DNAM immuno-oncology aspect lay the foundation for our current progress. Our lead program, COM701, originated from our computational discovery of PVRIG as a novel immune checkpoint and newly discovered inhibitory pathway in the DNAM axis. This finding was added to a prior discovery by us and by others, suggesting that TIGIT, our COM902 target, is an additional inhibitory pathway that is part of the DNAM axis.
Our research and preclinical data indicate that these two pathways are parallel and complementary inhibitory pathways in the DNAM axis, and have further strengthened our belief that in certain tumor types and patient population where the two pathways are operative, there may be a need to block both PVRIG and TIGIT in order to enhance potent anti-tumor immune response.
In addition, our preclinical data supports recent scientific findings by others indicating a molecular intersection between the DNAM axis and the PD-1 pathway, thus suggesting that various drug combinations that address PVRIG, TIGIT, and PD-1 may be required to target these three pathways in different cancer patient population and in cancer indications. While in some of the patients, blocking the PD-1 pathway will be sufficient, in others, the blockade of one or two of the other inhibitory pathways with or without PD-1 blockade may be required to generate potent immunotherapy treatment responses.
Before Henry provides detailed clinical updates, I'd like to spend a little more time highlighting our accomplishments, and what is to come in 2020. Last week, we presented updated data at the AACR Virtual Meeting which further support the safety and anti-tumor activity of COM701 as a monotherapy, and expands our data to include also COM701 in combination with Opdivo. As before, we believe our results, which now include two confirmed partial responses in addition to the high percentage of disease control rate in some durable responses of over six months across treatment arm, are particularly compelling as they were achieved in a dose-escalation setting in a highly refractory patient population.
We have completed the monotherapy dose escalation, and we're now working on completing the combination dose escalation. And importantly, we look forward to beginning our biomarker-informed monotherapy expansion cohort which are expected in Q2. Our monotherapy expansion cohort will include indications we believe are most likely to respond to COM701 as these were selected based on our analysis of DNAM axis biomarker expression profile and our clinical data.
In this monotherapy expansion study, biopsies will be collected before and on COM701 treatment to allow retrospective analysis of our DNAM axis biomarker approach. Additionally, we remain on track to begin our Phase 1/2 triple combination study testing COM701 with BMS Opdivo and their investigational TIGIT inhibitor in the second half of this year.
Moving to our TIGIT program, we were pleased to announce first patient dose in our Phase 1 dose escalation trial of COM902 in patients with advanced malignancies. This would enable us to clinically evaluate dual blockage of PVRIG and TIGIT inhibitory pathways in the DNAM axis.
We are encouraged by the biopharma industry's increasing interest in TIGIT; the potential clinical validation of the TIGIT pathway, combined with our encouraging signals of anti-tumor activity of COM701 as a monotherapy and in combination with PD-1 inhibitor further substantiates our hypothesis of the relevance of the DNAM axis and the PVRIG pathway in immuno-oncology.
This also serves as evidence in our view of the potential power and validity of our computational discovery platform. Having access to the only clinical stage PVRIG asset to our knowledge, highly differentiates us on testing the clinical relevance of this axis. And we look forward to driving our three parallel clinical studies in 2020, COM701 immunotherapy, COM701 Opdivo and TIGIT inhibitor triple combination therapy, and COM902 dose escalation.
Furthermore, in early Q1, we provided certain anticipated milestones and data readouts. At this time, despite the COVID-19 pandemic, we do not expect delays in our earlier guidance. We still plan to initiate and complete enrollment in our COM701 monotherapy expansion cohort, with initial data expected to be disclosed in the first half of 2021, disclose initial data from our COM902 dose escalation studies in 2021, and initiate our triple combination study with BMS in the second half of 2020.
Having said that, we are monitoring the situation on an ongoing manner, and we will share with you any material changes in our outlook if this may arise. While some of our sites are directing resources to COVID-19, overall today, we have not observed significant impact on patient enrollment and monitoring.
This could be for a number of reasons. First, the patient population we are enrolling is comprised of patients with advanced disease who have exhausted all available standard of care therapies. And second, we are seeing stages in which we are recruiting a very small number of patients. In addition to these two aspects, we believe that the number of clinical sites participating in our studies, our careful selection of a mix of academic and dedicated Phase 1 clinical trial sites to see only patients with breast cancer, and the diligence of the clinical investigator, all contribute to our current position.
But again, this may change, and we are in daily communication with the sites and are actively monitoring the situation. We have also continued our steady progress in strengthening our intellectual property portfolio aiming to keep to position of our assets as strong as possible. Adding to our previously granted composition of matter and used patents the US and Europe, we announced in Q1 a European patent for the use of any anti-PVRIG antibody that activates T cells and/or NK cells in the treatment of cancer, an additional European composition of matter patent for COM701 and backup antibodies for using the treatment of cancer, and the US patent for methods of screening of anti-PVRIG antibody that's inhibit the binding of PVRIG and PVRL2.
We were proud to recently announce the publication of preclinical data originating from our collaboration with Bayer on BAY 1905254, a first-in-class immune-oncology therapeutic antibody targeting ILDR2, which we discovered computationally and which is currently being evaluated by Bayer in a Phase 1 study in advanced solid tumor.
We believe this also serves as important validation of the power of our platform to computationally identify and test drug target while also establishing ILDR2 as a new immune checkpoint and a drug target being pursued in clinical studies. The recent accomplishments have contributed to Compugen's dramatic evolution over the past several quarters. We transitioned to a clinical stage Company with a growing body of encouraging data that support our unique approach as a target discovery and drug development biotech Company employing cutting edge computational biology to discover new biological pathways and novel drug targets to develop first-in-class drug candidate.
This quarter and despite challenging market condition, we were pleased to announce an approximately $79 million public offering that we believe is testament to the growing confidence in our Company and the power of our approach and capabilities. Our strengthened cash balance empowers us to continue our strong execution, pursue our strategic clinical plans, and advance our early stage program to propel our Company forward.
Before turning the call over to Henry, I would like to add that I am very proud of our employees and grateful for their dedication. These recent accomplishments and our tremendous progress over the past several quarters were made possible due to their hard work, drive, faith, and commitment for which I am incredibly grateful, particularly given this extraordinary circumstances we are now facing.
Under these circumstances, we remain focused on advancing our pipeline program and maintain positive momentum to achieve our long-term goal. I look forward to providing updates throughout the year.
And with this, I will now turn the call over to Henry. Henry?
Henry Adewoye -- Senior Vice President and Chief Medical Officer
Thank you, Anat, and good afternoon and good morning to everyone. As Anat mentioned, we have continued to report encouraging data from the ongoing COM701 Phase 1 dose escalation study which now includes new data from the monotherapy arm COM701 20 mg/kg IV Q4 weeks, the combination arm with Nivolumab or Opdivo, and an update on the two patients that were ongoing study treatment in Arm A, COM701 monotherapy at our last data disclosure at SITC 2019.
Last week at AACR, we presented clinical data from our ongoing Phase 1 clinical study designed to assess the safety and tolerability of escalating doses of COM701 monotherapy, as well as in combination with Nivolumab in patients with advanced solid tumors, who have exhausted all available standard therapies. This data builds upon our prior dataset presented at SITC in 2019, which included 13 patients in a, in the first seven dose cohorts of the monotherapy dose escalation arm of the study.
The data we reported demonstrated that COM701 was well tolerated with no dose limiting toxicities across all seven dose cohorts with dosing up to 10 milligrams per kilogram IV every three weeks. In addition, the data provided initial encouraging signals of anti-tumor activity with nine of 13 patients or 69% having a best time point anti-tumor activity of stable disease. These results are particularly noteworthy given the highly refractory and all comer patient population who had received a minimum of seven and a maximum of 15 prior lines of therapy prior to enrollment on this study.
We also reported anti-tumor activity in patients with microsatellite stable colorectal cancer, a challenging tumor type that is typically unresponsive to checkpoint inhibitors and for which there are no approved therapies. We reported stable disease in five of six patients with MSS CRC or 83%. Three of the six patients with colorectal cancer had kras mutation, all three patients had stable disease on this study. The data informed our decision to include eligible patients with microsatellite stable colorectal cancer as an indication in our upcoming expansion cohorts.
In our oral virtual presentation at the AACR, we reported the completion of all eight dose level cohorts in monotherapy, which now includes data from 16 patients and the first three or four dose level cohorts in the combination arm with 12 patients. Importantly, COM701 was well tolerated with no dose limiting toxicity, through 20 milligrams per kilogram IV Q4 weeks as monotherapy, and 10 milligrams per kilogram IV Q4 weeks every in combination with Nivolumab.
None of the patients discontinued solid treatment due to the toxicity of any of the study drugs. The most frequent adverse events observed in either arm was fatigue reported in 59% of patients and all between grade one and grade two. Majority of the adverse events in the safety analysis as reported in the study on both arms were grade one to two adverse events in ten out of 18 patients or 56% in Arm A, and seven out of 13 patients or 54% in Arm B, demonstrating no increased toxicity with the combination of COM701 and Nivolumab.
We also reported preliminary PK data that is supportive of dosing of COM701 IV Q4 weeks at the doses evaluated. Having previously reported at SITC 2019 that the PK profile of COM701 monotherapy permits IV Q3 weeks dosing, this new data permits us flexibility with the schedule of dosing of COM701.
We continue to report encouraging anti-tumor activity of COM701 monotherapy and now in combination with Nivolumab. We report two patients with confirmed partial responses. The patient with microsatellite stable platinum resistant primary peritoneal cancer, ongoing study treatment for 25 weeks on Arm A, and another patient with microsatellite stable colorectal cancer with KRAS mutation on Arm B ongoing study treatment for 44 weeks.
Notably, these ongoing responses in the microsatellite stable colorectal cancer and primary peritoneal cancer, a type of ovarian cancer, are supportive of our biomarker-informed selection of indications for the monotherapy expansion cohorts. We also reported a high disease control rate in both monotherapy and combination therapy arms. 69% or 11 out of 16 patients in the monotherapy arm, and 75% or nine out of 12 patients for the combination arm. This means that 69% of patients enrolled in Arm A, and 75% of patients enrolled in Arm B derived some clinical benefits on the study.
We are encouraged by the durability of study treatment considering the patient population enrolled on the study, patients who have exhausted all available standard therapies. Across Arm A and Arm B, we observed durable responses of at least stable disease for over six months, in six of 28 that is 21% of patients. Of the 12 patients enrolled in Arm B, six remain on study with a number of patients on treatment for over 200 days, and some approaching the one-year mark.
Taken together, this data are encouraging and support our preclinical hypotheses that inhibition of PVRIG-enhanced activation of antitumor immune response leading to tumor growth inhibition. The next step in our COM701 clinical program is the monotherapy cohort expansion. This study arm will utilize a biomarker-informed strategy to focus on tumor types based on our preclinical PVRL2 expression data and dose escalation clinical results that we believe are most likely to respond to treatment with COM701.
The COM701 monotherapy cohort expansion will enroll approximately 20 patients with advanced non-small cell lung, ovarian, breast, endometrial, and microsatellite stable colorectal cancer, all of whom have exhausted all available standard therapies.
We also will be examining our DNAM axis biomarker approach in biopsies obtained from patients before ongoing treatment to conduct retrospective biomarker analysis to inform on treatment outcomes.
Operational aspects for this part of the study are under way. An important clinical milestone of the quarter was the initiation of our Phase 1 study of COM902, our proprietary TIGIT inhibitor. This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of COM902 in patients with advanced malignancies, who have exhausted currently available standard of care therapies.
We believe having a wholly owned and scientific antibody is important for our overall clinical development plan and a significant differentiator in this space. Enrollment of patients into the COM902 dose escalation study is ongoing.
We look forward to initiating our Phase 1/2 triple combination study of COM701 with Nivolumab and BMS-986207, Bristol-Myers Squibb's investigational TIGIT inhibitor. We believe this is an important step toward testing our overall hypothesis on the role of DNAM axis and other pathways that intersect with it such as PVRL2/PVRIG, PVR/TIGIT and PDL1/PD1.
Our objective is to hopefully demonstrate that disabling the DNAM axis and other pathways that intersect with it will translate to clinically meaningful treatment outcomes for patients, such as overall response rates, progression free survival, duration of response, and possibly overall survival.
This planned Phase 1/2 open label study will evaluate the safety, tolerability and store activity of COM701 in combination with Opdivo and BMS-986207 in selected tumor types, mainly ovarian cancer, endometrial cancer, and the biomarker driven arm of tumor types with high expression of PVRL2.
The study will dose escalate COM701 with fixed doses of Nivolumab and BMS-986207. We remain on track to begin the study in the second half of this year.
It is clear that these are exciting times at Compugen, and we thank the patients participating in our clinical studies and their families. We also thank the investigators and study site personnel whose dedication despite the unprecedented challenges of COVID-19 make our studies possible.
To date, the impact on our studies has been limited and as Anat mentioned, we are in daily communication with the clinical study site and are monitoring the situation very closely. We remain committed to the advancement of all our clinical programs and are increasingly hopeful that we will help address the significant unmet needs of so many cancer patients by expanding the population that may benefit from immunotherapies from code to care.
With that, I will turn the call over to Ari.
Ari Krashin -- Chief Financial and Operating Officer
Thank you, Henry. Good morning and good afternoon to everyone. The first quarter of 2020 was transformational for Compugen. Today, we're better positioned financially as reflected by our improved cash balance and leaner expense structure and are enjoying greater market recognition. We're now well-positioned to advance our pipeline, both clinical and early stage and achieve our corporate goals.
Our financial results for the first quarter of 2020 released this morning continue to reflect the expenses associated with our ongoing Phase 1 study for COM701 and initiation of the Phase 1 study for COM902 as well as our strong financial position derived from our recent public offering, with gross proceeds of approximately $79 million including approximately $4.3 million received from the exercise of the underwriters option, which occurred after the end of the first quarter.
R&D expenses for the first quarter of 2020 were $4.7 million, compared with $6.3 million for the same period of 2019. This decrease of over 25% is mostly attributed to the restructuring process we announced at the end of the first quarter of 2019 offset by increased clinical expenses associated with our growing clinical programs.
As a reminder, in the first quarter of 2019, our clinical expenses were related solely to the COM701 monotherapy dose escalation study, while today, they reflect costs associated with our extended clinical programs, which now also include the dose escalation of COM701 in combination with Opdivo and the dose escalation study for COM902. Net loss for the first quarter of 2020 was $7.1 million, or $0.10 per basic and diluted share, compared with a net loss of $8.4 million or $0.14 per basic and diluted share for the same period of 2019.
As of March 31st, 2020, we had approximately $121 million in cash and cash related accounts compared with approximately $44 million as of December 31st 2019. The Company had no debt in either period. The increase in our cash balances of approximately $77 million during the first quarter is mostly attributed to approximately $70 million of net proceeds received in a recent public offering approximately $5.2 million received from exercise of warrants and approximately $7.2 million received from exercise of employee options, offset by operating expenses and working capital.
As noted earlier, an additional amount of approximately $4 million of net proceeds related to the recent public offering was received after the end of the first quarter and is not reflected in the cash balances as of March 31st, 2020. Total cash expenditures on a full-year basis is still expected to be approximately $27 million. As Henry and Anat have indicated at the moment, we're not experiencing any significant impact from COVID-19 on our operations and as such, our cash expenditure outlook for the year has not changed at this time. It is important to note that the thoughtful approach in which we manage our cash resource in the past will continue. At the moment, based on our current plans, we do not expect to increase our level of expenditures in a significant way going forward.
Now, before opening the call for any questions, I would like to thank our investors for the continued support and confidence in Compugen. Thank you for joining us today, and on behalf of the entire Compugen family, we hope you stay safe and healthy.
Thank you. And with that, we will now open the call for questions.
Questions and Answers:
Operator
[Operator Instructions] The first question is from Mark Breidenbach of Oppenheimer. Please go ahead.
Matthew Biegler -- Oppenheimer -- Analyst
Hey, guys. This is Matt on for Mark. Thanks for taking our questions, and congrats on the recent progress. Anat, I apologize if I missed this, but I just wanted to clarify whether the triplet trial will be all-comers by design or if you are going to be deploying a biomarker-guided eligibility strategy?
Anat Cohen-Dayag -- President and Chief Executive Officer
Yes. Hi, Matt. So obviously, dose escalation is an all-comers study. But we designed for three arms. One is for ovarian, the other one for endometrial, and the third one is a biomarker driven PVRL2 high patient population; different type of indications.
Matthew Biegler -- Oppenheimer -- Analyst
OK, got it. That's very helpful. And then maybe if you could just provide more detail on the development strategies for 902, should we expect that Phase 1 trial to really look at lot like the COM701 trial did, and in the future, are you planning on using biomarker-guided expansion cohorts?
Anat Cohen-Dayag -- President and Chief Executive Officer
So right now, obviously, this is a study, it's the dose escalation as a monotherapy, and it is being designed to be tested in patients with advanced malignancies who have exhausted all available standard therapy. Going forward, I'll remind that we developed COM902 in order to make sure that, as a complementary asset to COM701, we want to make sure that we can execute on our COM701 strategy, and prove the hypothesis that we identified scientifically first computationally, and then by experimental procedures per clinically that TIGIT and PVRIG pathways are working in parallel and in complement. And for that we would like to advance COM902 to be able to test it in combination with COM701.
Obviously we are conducting a triplet study with Opdivo and the TIGIT inhibitor of BMS, which is great, and it's advancing our timelines, and it's a win-win for Compugen and BMS, but we want to make sure that we keep pushing our strategy forward and test COM902 plus COM701 also independent of PD-1, and that's important for us. Having said that, we have a clinical stage asset, there is interest in the industry with respect to TIGIT. And we're waiting to see the data and the efficacy for TIGIT. And we will make plans as we move forward for COM902, also independently of COM701. So the first priority is making sure that it's complimentary to COM701, but then we will make sure that we pursue the value of this asset as much as possible.
With respect to biomarker strategy, obviously TIGIT is part of the DNAM axis, and we as a company we were looking at all these axis -- all the different pathways and our approach looking at the different family members -- sorry, the different axis members, by meanings to chemistry, we will probably also extend it to the TIGIT study, but it's not at this stage, and we will share our biomarker strategy for our own COM902 program when we'll have it ready.
Matthew Biegler -- Oppenheimer -- Analyst
Got it, that makes sense. And then just maybe one more if I may. So just in terms of data readouts, are you still planning on providing data from the doublet combination dose escalation cohorts some time in the second-half?
Anat Cohen-Dayag -- President and Chief Executive Officer
So, we actually advanced timelines and presented data at AACR and most of the combination and dose escalation study is already shared with the public. Obviously we'll have more data, but we'll find the time to present it, the next data readout, as I stated in the prepared remarks, are starting in the first-half of 2021, and we'll find the time to combine these data as well in our next disclosure.
Matthew Biegler -- Oppenheimer -- Analyst
Great, thanks for taking our questions.
Operator
The next question is from Asthika Goonewardene of SunTrust Robinson Humphrey. Please go ahead.
Allen Donne -- SunTrust Robinson Humphrey -- Analyst
Hey, there. This is Allen on for Asthika. Thanks for taking my questions. So I guess following-up on the points that you had made on the biopharma interest in TIGIT and also taking a look at the potential efficacy of TIGIT with the Roche data coming up at ASCO, I guess we were curious on what you'd be looking for, I guess, a meaningful readout of that data, and I guess, would you be able to give us an idea of how that translate to either your triplet combination that's planned to start in the second-half or for just your COM902 program? Thanks.
Anat Cohen-Dayag -- President and Chief Executive Officer
So, obviously, we're not familiar with any of the data, and we will look to see -- I think the interest of the industry is mainly by the action for the announcement that Roche made, but we will wait to see. We don't put any threshold to what is an activity for the TIGIT. I think that it still remains to be seen what is the activity of TIGIT, from our perspective, we believe that the three pathways together blocking them in a situation wherein patient populations where the three pathways are operative, and we believe based on our data, the research and the preclinical data that this should enhance anti-tumor activity, and the relative contribution of TIGIT on this front, it remains to be seen, and we don't put any threshold on this. We will test it on our own. More than that, combining TIGIT and PVRIG may generate different outcome in a different patient population in different indications. So, we're not putting any threshold to the initiation of our studies.
We will start our studies, and we will show the relative value of each and how they're operating together. As a monotherapy for COM701, COM701 in combination with COM902, so blocking PVRIG and TIGIT, which by the way should also enhance DNAM, and blocking the triple pathway, which may block three next set of regulatory pathways and stimulate the stimulatory path which is DNAM. So, it's really looking at the full perspective. So currently no specific threshold, we will be very happy to see a clinical activity for TIGIT inhibitor for two reasons. Firstly, it will continue to support our hypothesis, but also remember we discovered it computationally and published it at the time the Genentech published it in 2009, so we're very proud if this will be clinically validated pathway, this will be great for us, but we're not putting any limits to start our own study.
Allen Donne -- SunTrust Robinson Humphrey -- Analyst
All right, guys, it's very helpful. And then one more if I may on COM902, I guess with the first patient dose already, how should we think about maybe the different dose cohorts that you'd be considering going forward?
Anat Cohen-Dayag -- President and Chief Executive Officer
I will let Henry relate it, but I think that you know, we take it one step at a time, data driven and we'll just -- but Henry, would you like to address it?
Henry Adewoye -- Senior Vice President and Chief Medical Officer
Yes, thank you so much Anat. Yes, we'll take it one step at a time. But we're going to follow what was typically done in dose escalations for most of these therapies. So it could be a rules based design. Rules based meaning, there are certain number of patients that are evaluated. We'll see over a predefined number of days, that's the first cycle, typically, to see if there are any DLTs. The number of patients that we are going to enroll will depend on how long each of this DLT evaluation periods for the number of subjects that will be enrolled will be. So, for example, if we enroll one subject, it's much faster than if you enroll three subjects. So the rules based that I'm talking about, is something similar to maybe a three plus three design or a single subject cohort, but essentially, the rules are based on the predefined items or parameters for DLT evaluation. So, its going to be similar to what we have on COM701 in brief.
Allen Donne -- SunTrust Robinson Humphrey -- Analyst
All right, got it. Thank you and congratulations on the progress.
Anat Cohen-Dayag -- President and Chief Executive Officer
Thank you, Allen [sic].
Operator
The next question is from Colin White of Jefferies. Please go ahead.
Colin White -- Jefferies -- Analyst
Hello. It's Colin White from Jefferies here. I have a couple of questions if I may on TIGIT. The first question I had was just about whether there was anything in any of the pre-clinical data or anything you've seen for your TIGIT, which in any way makes you think it maybe differentiated from any of the competitors TIGITs? And then the second question I have, just a follow on from the previous questions was, you've mentioned there that you saw -- with Roche's data clinical activity, that it would be good because it validates the TIGIT pathway. But should, in a scenario where the Roche data, which was to look underwhelming, would you say we should be cautious about reading too much through about the potential of your TIGIT or of your programs?
Anat Cohen-Dayag -- President and Chief Executive Officer
It's an interesting question. So just with respect to differentiation, our antibodies are ultra-high affinity antibodies. So that is a better and differentiating factor, but we don't know how it will to in the clinic. So I wouldn't think about our TIGIT test completely differentiating. I think the key differentiation for us at Compugen, is the fact that we have COM701, we have clinical stage PVRIG anti-body and we think that it is needed in specific patient populations, in specific cancer indications. So this is our key differentiator.
Talking about the data being overwhelming and our own TIGIT, as I said, I don't consider at this stage our TIGIT as a key differentiator for the company. But I do think and that's similar to what I was saying to Asthika, for us, the bar for TIGIT activity, will just serve as a starting point to show whether we can enhance with PVRIG and with PVRIG plus PD-1 blocker. So it's really from our perspective, it's a start, so -- no, I think that we still need to prove the DNAM axis hypothesis, the involvement of the three pathways, and the fact that the most we view as enhancement of anti-tumor activities really occurring. And I'll just say that our first set of data with monotherapy is -- and also with the combination in the dose escalation, is encouraging, because it supports what we're saying for quite some time. It's initial, but it's highly supportive.
Colin White -- Jefferies -- Analyst
That's great. Thank you.
Anat Cohen-Dayag -- President and Chief Executive Officer
Thank you, Colin.
Operator
The next question is from Tony Butler of ROTH Capital. Please go ahead.
Tashdid Hasan -- ROTH Capital -- Analyst
Good morning. This is Tasha in place for Tony. Thank you for taking my question; number one, is there a data on PVRIG and/or TIGIT mRNA in normal lymphocytes versus those found in the tumor?
Anat Cohen-Dayag -- President and Chief Executive Officer
Are you specifically interested in the mRNA or why is it specifically mRNA? I can answer about the protein level, which I think is more important. There is an over expression in the tumor microenvironment of the PVRIG as compared to normal cells.
Tashdid Hasan -- ROTH Capital -- Analyst
I mean, in the tumor microenvironment, things change. So, if there is a differentiating data whether it's your internal data or whether you would like me to -- like to point me toward an existing publication either/or is good enough?
Anat Cohen-Dayag -- President and Chief Executive Officer
Sure. So, as I said, in the tumor microenvironment the PVRIG levels are overexpressed as compared to normal cells, and I just referred to the fact that it's a protein level and not at the mRNA level. I am not sure that I know to answer the data for the mRNA level. But I think it's of less interest.
Tashdid Hasan -- ROTH Capital -- Analyst
Sure. And have you observed any changes in the tumor cell -- any changes in these biomarkers and tumor cells in response to external stress? For example, either -- let's say either radiation or application of chemo?
Anat Cohen-Dayag -- President and Chief Executive Officer
So, PVRIG is expressed on the T cell within the tumor microenvironment, and by the way, on the most exhausted CD8+ cells, if you express together with TIGIT and PD-1. I am not sure that I have the answer with respect to external stimuli offhand at this moment.
Tashdid Hasan -- ROTH Capital -- Analyst
No worries. Thank you for your time.
Anat Cohen-Dayag -- President and Chief Executive Officer
Thank you.
Operator
This concludes our question-and-answer session. I will 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. Our 2020 is off to a strong start. Our ongoing COM701, Phase 1 study is progressing well. We recently disclosed encouraging data from both the monotherapy and the combination dose escalation arms, and we are gearing up to initiate the next phase of the trial; the monotherapy extension cohort during this quarter. We are also on track to begin in the second half of 2020, the triple combination study for COM701, with BMS Opdivo and investigational anti-TIGIT inhibitor, which will allow us to directly test our hypothesis on the DNAM axis. With a stronger balance sheet, we are well positioned to continue executing on this expanded clinical development plan, investing in our early stage programs to drive our future therapeutic pipeline and maintain this positive momentum.
Thank you all for joining us today. We look forward to updating you on our progress through the year. Stay safe and healthy. Thank you.
Operator
[Operator Closing Remarks].
Duration: 51 minutes
Call participants:
Elana Holzman -- Director, 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
Matthew Biegler -- Oppenheimer -- Analyst
Allen Donne -- SunTrust Robinson Humphrey -- Analyst
Colin White -- Jefferies -- Analyst
Tashdid Hasan -- ROTH Capital -- Analyst
