Ladies and gentlemen, thank you for standing by. Welcome to Compugen's First Quarter 2020 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 Web site 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, 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 24, 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?

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 recent activity and implemented mitigation plans to minimize the impact on our clinical programs, which I will be discussing more details shortly, as well as our early-stage pipeline program. Simultaneously, we're preparing for escalating scenarios nationwide or companywide. 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 program discovered computationally…

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 in combination 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 in 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 or available standard therapies. This data builds upon our prior dataset presented at SITC in 2019, which included 13 patients in the first seven days course 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 9 of 13 patients or 69% having the best time point anti-tumor activity of stable disease. These resolved are particularly noteworthy given the highly refractory and all patient population who had received immediate 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. It challenging to what that is typically unresponsive to checkpoint inhibitors and for which there are no approved therapies. We reported stable disease in five or six patients with MSS CRC or 83%. Three of the six patients…

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 release 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 a recent public offering, with gross proceeds of approximately $79 million including approximately $4.3 million received from the exercise of the underwriters option, which appeared 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 31 2020, we had approximately $121 million in cash and cash related accounts compared with approximately…

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

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?

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.

Okay, 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?

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 and all the different pathways. And our approach looking at the different family members -- sorry, at the different axis members [indiscernible] 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.

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?

So we actually advanced timelines and presented data at AACR. And most of the combination 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.

Great, thanks for taking our questions.

The next question is from Asthika Goonewardene of SunTrust Robinson Humphrey. Please go ahead.

Hey, there. This is [Allen] [Ph] 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.

So, obviously, we're not familiar with any of the data, and we will look to see -- it's only -- 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.

All right, guys, it's very helpful. And then one more if I may on COM902, I guess for the first patient dose already, how should we think about maybe the different dose cohorts that you'd be considering going forward?

I will let Henry relate it, but I think that we take it one step at a time, data driven and we'll just but Henry, would you like to address it?

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 rules based design, rules based meaning, a 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're any DLTs. The number of patients that we're going to enroll will depend on how long each of this DLT evaluation periods for the number of subjects that will be enrolled. So, for example, if we enroll one subject, it's much faster than if you enroll three subjects. So, the loose space that I'm talking about is something similar to maybe three plus three design or singles subject cohort, but essentially, the rules are based on the predefined items or parameters for DLT evaluation. So, it can be similar to what we have on COM701 in brief.

All right, got it. Thank you and congratulations on the progress.

Thank you, Allen.

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

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 is anything in any of the pre-clinical data or anything that you've seen for your TIGIT, which in any way makes you think it maybe differentiated from any of the competitors TIGIT. And then the second question I have just to follow on from the previous questions was, you've mentioned there that you saw 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 the loop underwhelming, would you say we should be cautious about reading too much through about the potential of your TIGIT or your programs?

It's an interesting question. So, just with respect to differentiation, our antibodies are ultra-high affinity antibodies. So that is a differentiating factor, but we don't know how it will translate to in the clinic. So I wouldn't think about our TIGIT test completely differentiating. I think that the key differentiation for us to comprehend is the fact that we have COM701, we have a 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 in that similar to what I was saying to a speaker. It for us, the bar for TIGIT activity, and we 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 this, our first set of data with the monotherapy is, and also with the combination in the dose escalation, it's encouraging, because it supports what we're saying for quite some time. It's initial, but it's highly supportive.

That's great. Thank you.

Thanks, Colin.

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

Good morning. This is [indiscernible] 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?

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, and -- of the PVRIG as compared to normal cells.

I mean in the tumor microenvironment environment, 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 towards an existing publication either is good enough.

Sure. So, as I said, in the tumor microenvironment the PVRIG levels are over expressed as compared to normal cells, and I just referred to the fact that it's a protein level and not the mRNA level. I am not sure that I know to answer the data for the mRNA level, but I think it's reflecting to it.

Sure. And have you observed any changes in the tumor cells -- 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?

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.

No worries. Thank you for your time.

Thank you.

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?

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 arm, 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 being in the second half of 2020, the triple combination study for COM701 with BMS Opdivo and investigational anti-TIGIT inhibitor which will allow a hypothesis on the DNAM axis. With a stronger balance sheet, we are well positioned to continue executing on this expanded clinical development plan, investing our early stage programs to drive our future therapeutic pipeline and maintain the 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.

Thank you. This concludes the Compugen Ltd. first quarter 2020 financial results conference call. Thank you for your participation. You may go ahead and disconnect.