Ladies and gentlemen, thank you for standing by. Welcome to Compugen's Fourth Quarter and Full Year 2019 Results Conference Call. At this time, all participants are in a listen-only mode. An audio webcast of this call is available in the Investors section of Compugen's website www.cgen.com. As a reminder, today's call is being recorded. I would now like to introduce Elana Holzman, Compugen's Director of Investor Relations and Corporate Communications. Please, go ahead.

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 our future business outlook, our business model, our development and collaboration efforts and their outcome, our discovery platform, anticipated progress and time line for our existing and pipeline programs and financing and accounting-related matters, as well as statements regarding our cash position, cash resources and results of operation. We wish to caution you that such statements reflect only the company's current expectations, and involve known and unknown risks and uncertainties that may cause actual results, performance or achievements of the company to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. 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 March 21, 2019. The company undertakes no obligation to update projections or forward-looking statements in the future unless required by law. I will now turn the call over to Anat. Anat?

Thank you, Elana. Good morning and good afternoon, everyone, and welcome to our fourth quarter and full year 2019 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. Starting off, I’m very proud to be here today sharing our tremendous accomplishments throughout the past year. We have entered 2020 truly transformed, positioned to realign the potential of our computational predictive target discovery capabilities. These capabilities have enabled us to discover three new drug target for which antibodies have been developed into clinical programs that are being advanced internally by us or by pharma partner. Importantly, we now also have encouraging initial clinical data for COM701, our first internally developed and most advanced asset. These data combined with our overall science driven clinical strategy and an efficiently executed and extending clinical program proposed as forward to an exciting time in the evolution of Compugen. Before we go through some of our 2019 accomplishments and preview what’s to come, I would like to review how our discoveries on the DNAM immuno-oncology axis laid foundation for where we are today. With our computational discovery capabilities focused on the field of immuno-oncology our lead program COM701 stems from our discovery of PVRIG at the novel immune checkpoint and newly discovered inhibitory pathway in the DNAM axis. In addition, our data suggest that TIGIT and additional inhibitory pathway discovered previously by us and others, along with PVRIG are two parallel and complementary inhibitory pathways in the DNAM axis. Our view is that in certain tumor types in patient population where the two pathways are operative there may…

Thank you, Anat, and good afternoon and good morning to everyone. As Anat mentioned, we have made significant strides with our ongoing Phase 1 dose escalation study. The investigators continued to be entering the aspect of other clinical trial and remain encouraged by the initial clinical data disclosures at SITC in November 2019. As you know, the data presented were from our ongoing Phase I clinical trial designed to assess the safety and tolerability of escalating doses of COM701 monotherapy, as well as in combination with Bristol-Myers Squibb Opdivo in patients with advanced solid tumors who have exhausted all available standard therapies. The data prevented us from the 13 patients in Arm A, the first seven dose cohorts of the monotherapy dose escalation arm of the trial. From a safety and tolerability standpoint, COM701 was well-tolerated with no dose-limiting toxicities across all seven dose cohorts with dosing up to 10 milligrams per kilogram every three weeks. The patients treated Arm A of this trial were heavily pre-treated with the number of prior anticancer treatments for these 13 patients linked in from 2 to 15 with a median of 7. In addition to evaluating safety and tolerability, we also reported on preliminary anti-tumor activity of COM701 monotherapy. We and the investigators were encouraged to see initial signals of anti-tumor activity in this heavily pretreated patient population. The overwhelming majority of the patients enrolled 9 of the 13 patients, in other words 69% had the best time point anti-tumor activity of stable disease. As a reminder, based on the certain patients had prior treatment refractory disease leaving the best anti-tumor activity reported with a less therapy prior to enrolment on our study with progressive disease. On COM701 monotherapy, five of these patients have stable disease of their initial assessment. We’re encouraged by…

Thank you, Henry. Good morning and good afternoon to everyone. Our financial results for the fourth quarter and full-year of 2019 released this morning reflect the continued expenses associated with our Phase 1 study of COM701, as well as the restructuring process we implemented at the end of the first quarter of 2019. We’re pleased with the significant reduction of expenses we were able to achieve and with our improved financial position. Research and development expenses during the full-year 2019 decreased by approximately 35% in total $19.8 million, compared with $30.3 million in 2018. For the fourth quarter of 2019, research and development expenses were $4.3 million, compared with $7.5 million in the prior year period of 2018. The decrease in both cases attributed mostly to the restructuring process we announced at the end of the first quarter of 2019, as well as the clinical activities related to COM902 most of which will conclude that in 2018. This reduction was offset by an increase in expenses associated with the clinical related activities of COM701 Phase 1 trial, which began in the second half of 2018. Marketing and business development expenses during 2019 decreased by approximately 50% and total $0.7 million, compared with $1.6 million in 2018. The decrease is attributed mainly to the expenses associated with our revenues during 2018 and the temporary reduction in headcount during 2019. Net loss for 2019 was $27.3 million or $0.43 per basic and diluted share, compared with a net loss of $22.6 million or $0.41 per basic and diluted share for 2018. Net loss for the fourth quarter of 2019 was $6.5 million or $0.10 per basic and diluted share, compared with a net loss of $9.4 million of $0.16 per basic and diluted share for the comparable quarter of 2018. As of…

Thank you. Ladies and gentlemen, at this time, we will begin the question-and-answer session. [Operator Instructions] The first question is from Mark Breidenbach of Oppenheimer. Please go ahead.

Thanks for taking the questions and congrats on the progress. I think the triple combination trial makes a lot of sense and we’re excited about this one. Maybe let me start with one or two for Anat, and then, one for Henry to follow with. So, Anat, undoubtedly you’re aware of Roche Genentech’s investment in its TIGIT program and their announcement about the new SKYSCRAPER-02 trial, which is focusing on small cell lung cancer. I’m curious if Roche’s plans around their TIGIT antibody have in any way impacted your development plans for COM701? And is small cell lung cancer something where you would expect PVRL2, PVRIG to play an important role?

So, thank you Mark. Yes, we’re aware of the announcements by Roche. So, first, I’ll just say that with respect to TIGIT and its potential in this axis and together with PVRIG, we're talking about it for quite a long time. We’re expecting because Genetic is more advanced there. I think, we’re expecting to hear about their data or any hints about the TIGIT pathway being active, so we’re very happy with this because it is actually reinforcing what we’re saying for quite some time and we do believe that in certain patient populations where both the PVRIG and TIGIT pathways are complementary and are active that PVRIG will add to this activity. So, that’s our hope and this is what we’re focused to do. In terms of lung cancer, obviously when we were discussing the selected indications for COM701, we were selecting those that we think that the PVRIG pathway is more expressed and therefore patients are more likely to respond, and if you remember, we selected ovarian endometrial breast but also lung cancer and we think that the PVRIG pathway may have a role also in lung cancer and we’ll see. You know, we are positioned as the company that – you know the only company to the best of our knowledge with a clinical stage assets; we’re positioned to protect it. So, we’ll see.

Okay. And I also noticed that they are including chemotherapy in combination with their TIGIT and their PD-L1 antibody, is that something you consider down the road in your collaboration with Bristol-Myers Squibb?

So, it’s – we’re not rolling this out. Remember that our agreement with BMS allows us to test various type of combination, so it was from the beginning we didn’t only focus on COM701 and Opdivo; we will consider. Chemotherapy could be added based on their scientific rational for some of the indications and for others, it could be added just because this is the standard of care, and you want to be able to add your treatment to standard of care. And so, everything is open for us. For now, we’re clearly focused on the triple, which is the critical path for us to ultimately prove what we’re saying for quite a long time and we’re accelerating here with this expansion of the agreement our timelines forward together.

Okay. Okay, perfect. And a quick one for Henry, if I can, with regard to the two-dose escalation arms that are ongoing right now, can you – tell us how – you know with the 20 mig per kig Q4 weekly dosing arm, is that the last escalation arm for the monotherapy trial? And can you tell us how many more dose escalation cohorts you intent to enroll in the Opdivo-COM701 combination before wrapping up that trial?

Well, thank you very much Mark. At this point, it seems the trial is ongoing and enrolling patients. It would be premature to indicate if this will be the last dosing cohort we will have. We will be able to disclose additional information once we’re able to get all the data in that we’re looking at, so the data I’m referring to would be not just the clinical data, but also the laboratory data also, and most of it not just in the first – within the DLT window that’s the first cycle, but subsequent cycles also. So, we’ll see as the trial unfolds. Remember one of the things that we’re interested in there in the conduct of this trial is trying to figure out if we will be able to achieve a maximum tolerated dose. For most of the check points that have been developed, it doesn’t have PR2 days one. So, what I can tell you for certain now is, it will be premature to see if this will be the last dosing cohort for the monotherapy dose escalation. And also in terms of the monotherapy, the combination with Opdivo-COM701 plus Opdivo, also premature to indicate how many dose level cohorts we will test because, as you know, this is a Phase 1 study and we’re just interested in determining the safety and tolerability of the combination, and this will be very important for us because it will inform also what the projected toxicities will be for the triplet combination that Anat mentioned earlier during the call.

Okay, perfect.

Yes, and I just would like to add, and Henry, thank you very much on this, but I just would like add, Mark, in order to add some additional context on information that we already disclosed, so we did – we do anticipate to initiate enrollment for the monotherapy dose expansion arm in 2020 and to complete enrollment in 2020 and to release data in the first half of 2021 for the monotherapy expansion cohort. So, that gives you some time frame to what we’re looking for, and also for the dual dose escalation COM701 plus Opdivo, we already stated as well that we’re going to present data in the – that we aim to present data in the second half of 2020, so that also puts things in perspective while, as Henry said, the study is ongoing.

Right. And when you present the dual combination dose escalation result later this year, can we also expect may be extended follow-up from the monotherapy dose escalation cohorts as well?

Yes, it could be yes. We will present a data that we have available, yes.

Okay. Well, thank you very much for taking the questions and congrats again.

Thank you.

The next question is from Varun Kumar of Cantor Fitzgerald. Please go ahead.

Hi, good morning everyone, and thanks for taking the questions. First on triplet, you know, you specifically mentioned ovarian and endometrial as, you know, expansion cohort, which could come in future, so maybe first, what’s the rationale of these two cohorts in particular for the triplet regimen, maybe, Anat, if you can answer that?

Yes, sure. So, as we stated, ovarian and endometrial were selected for us also for the monotherapy on top of the fact that [indiscernible] to test breast and the lung cancer, and also we added recently colorectal based on the monotherapy dose escalation data. On the triplet, we wanted to make sure that we focused on indications that we also have the monotherapy expansion cohort. We selected ovarian and endometrial because of the high expression as in the other indications that we selected like breast and lung. The high expression of the PVRIG pathway, that’s a biomarker informed decision and that’s the reason these two indications are part of the triplet.

Thanks for the color.

Go ahead, sorry.

So, you know, wanted to have a follow up as well on, you know, the triplet. Now given you are having Bristol TIGIT in this study, I was trying to understand how strategically you are thinking about your own TIGIT. I understand you will have Phase I study with 902, but, you know, how strategically you will position your TIGIT molecule given you have now, you know, Bristol TIGIT in the clinical study?

So, first, you know, having Bristol TIGIT in the study is great and its win-win for both companies in terms of accelerating the timelines and making sure that we’re on the critical path to go ahead into these axis that also get observed more as focusing recently and just move on quickly. Our own TIGIT is actually – it’s a separate story. We develop our own TIGIT in order to make sure that we can test, execute on the overall COM701 clinical strategy. In this strategy, we would like to make sure that we can test COM701 plus COM902 in certain patient populations. We, as a small company, we need to make sure that we have access to everything that we need in order to move ahead and we are looking to extend our relationship with BMS, as much as possible and they are a great partner for us, but as a small company, it’s a clinical collaboration we need to make sure that COM701 is the key lead asset for Compugen, and we need to make sure that we have the component in order to move quickly forward as needed. In general, this strategy for COM902, on top of the fact of combination with COM701, obviously that’s a clinical stage asset now, and if TIGIT is a validated pathway as we think it should be then from our perspective, we have a clinical stage asset of a validated pathway and if there are any opportunities that are outside of TIGIT plus PVRIG, obviously we’re going to assess it in an ongoing manner, and decide whether we want to pursue our own TIGIT antibody in additional – on additional fronts in additional business and combination opportunity.

That’s very helpful, Anat. Maybe last question if I may on 701, now it’s really exciting to see that you – you know you’re driving the monotherapy as well and expansion cohorts looks like the data is still expected in first half next year, I just wanted to understand is a goal there with monotherapy 701, you know, is the idea to have it be more informative study? Or do you think there could be a path forward with single agent in terms of regulatory, you know, path as well, if you get some excited data there in solid tumor?

First, obviously, this is a completely new agent. As Henry is saying all the time, we need to know as much as we can on days on the safety profile, the tolerability and everything possible so that’s part of the reason for us to move forward. By personally I’ll tell you, that obviously our data is supportive of tumor growth envisioning preclinical models, up until now, checkpoints that were showing preclinical data other than PD-1 and CTLA4 did not show encouraging – maybe not all of the checkpoints, but most of them, encouraging clinical data, and hopefully TIGIT is bypassing this barrier now, but for COM701, you know that even in the dose escalation stage, where we had heavily pre-treated population, median of treatments of [seven] really exhausted patients and we were able to see some encouraging initial signs of – you know of possible activity and that’s the reason we added colorectal to the monotherapy. Look, we selected these indications because we thought, we think that these are the indications where this pathway should be more active. These patients and these indications are likely to respond and we’ll test it. Hopefully, we will be able to see also monotherapy, but I think that in general, in this space, if you want to hold your breath, I guess its combo, right? So, I'm not ruling out the monotherapy front obviously, but I think that – and we’re pushing forward as quickly as possible, but I think that with our theory about the three pathways, we look forward into getting data of combination study.

That’s very helpful. Thank you, Anat and Henry and Ari as well. Congrats on the progress.

Thank you.

Thank you.

And the next question is from Colin White of Jefferies. Please go ahead.

Hi, it’s Colin White from Jefferies here. So, on the recent Genentech call, they were discussing the possibility of combining an anti-TIGIT and an anti-PD-1 with [indiscernible] to help us in that NK cell expansion. You’re obviously testing your triplet, anti-TIGIT, anti-PD-1 and then COM701, so I was just wondering if you could share any thoughts on the possible advantages of your strategy and whether or not you can settle in combinations with [indiscernible]. Resolution?

I think that maybe just I’ll relate – in order to address your question, I’ll relate to the three pathway signs driven any positives that we have. So, we think that in different patient populations, there may be different need for different combinations, so – I’ll just elaborate, so, you know, that for patients where PD-1 pathway is more dominant, treating them with PD-1 blocker would probably get this patient to respond, but we think that in other patient populations where the PD-1 pathway is maybe less dominant and there are additional pathways or other pathways that are dominant, you would need to treat with additional or other agents and that’s our [indiscernible] reflected this triple pathway, and we’re going to test it that’s our clinical strategy. So, we think that there is room for TIGIT plus PD-1, but there is also obviously a room for TIGIT and PVRIG and that could be in different patient populations, in different cancer indications and even in – may be in overlapping for the treatment. So that’s our hypothesis and the clinical strategy. With respect to cytokines I think that it goes to a more broader question with respect to infiltrated tumors and excluded tumors and desert tumors where – you know where T-cells are not injected into the tumor microenvironment and that goes into how you release the immunosuppressive tumor microenvironment in order to be more permissive in our [indiscernible] and then you can treat them with checkpoint inhibitors, and obviously, there are different modalities that are being tested now that are dealing more with changing the inhibitory profile of the tumor microenvironment. And cytokines could well address this; you know we’ll see how this data is panning out.

Okay. Just a follow-up with one question about the [indiscernible] study design, I mean how will the study show the contribution of COM701, is that a part of the way the study is going to be designed?

So, specifically for the design, and Henry feel free to jump in if you want to, but specifically for the design, we – you know we’re – we’ll share more data after the study design is formalized, and you know, we need to submit a protocol and get clearance for the IND. So, we’ll share more data about the study design itself.

Okay, thanks.

Yes, I concur in that’s, and it’s a very good question Colin, which will start off internally also, but like Anat mentioned in her prepared address, that we’re trying to get to the core of this, which is evaluating the axis, the DNAM axis and blocking the various factors in this access. So that will answer the question. And then, trying to figure out the contribution of the relative – of the two or the three molecules then becomes a little bit easier to address versus that seeing the data come in. Let me segue a little bit back to the question that both Mark and Varun talked about, so here lies the reason why the COM701 monotherapy expansion will continue in the selected tumor types with high expression of PVRL2. That data will not just be informative in terms of the anti-tumor activity, but also satisfies regulatory criteria in trying to [indiscernible] what the contribution of COM701 is and will be, so that partially addresses that also.

That’s great. Thanks.

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?

Thank you. During 2019, we made significant progress in our clinical development plans for COM701, our leading immuno-oncology asset, and in 2020, we will be contacting in parallel three clinical studies, COM701 monotherapy; the treatment combination study of COM701 with Bristol’s Opdivo and TIGIT inhibitor; and COM902 dose escalation. Our ongoing clinical studies, with the support of Bristol-Myers Squibb will advance the clinical evaluation of our hypothesis regarding the potential role of the PVRIG pathway within the DNAM axis and PD-1 pathway. This is particularly exciting given the growing industry focus on this axis. We remain optimistic and with the hope to expand the reach of [indiscernible] therapy to new cancer types and patient populations. I’m extremely pleased with the progress we have made during 2019 and enthusiastic going into 2020 well positioned to execute. We look forward to sharing with you additional data during 2020 and in 2021. Thank you for joining us on the call today.

Thank you. This concludes the Compugen Ltd. fourth quarter and full-year 2019 financial results conference call. Thank you for your participation. You may go ahead and disconnect.