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Edited Transcript of CGEN.TA earnings conference call or presentation 20-May-19 12:30pm GMT

Q1 2019 Compugen Ltd Earnings Call

Tel Aviv May 28, 2019 (Thomson StreetEvents) -- Edited Transcript of Compugen Ltd earnings conference call or presentation Monday, May 20, 2019 at 12:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Anat Cohen-Dayag

Compugen Ltd. - CEO, President & Director

* Ari Krashin

Compugen Ltd. - Chief Financial & Operating Officer

* Elana Holzman

Compugen Ltd. - Director of IR & Corporate Communications

* Henry Adewoye

Compugen Ltd. - Chief Medical Officer

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Conference Call Participants

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* Edward Andrew Tenthoff

Piper Jaffray Companies, Research Division - MD & Senior Research Analyst

* Lucy-Emma Mary Sarah Codrington-Bartlett

Jefferies LLC, Research Division - Equity Analyst

* Mark Alan Breidenbach

Oppenheimer & Co. Inc., Research Division - Executive Director & Senior Analyst

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Presentation

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Operator [1]

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Ladies and gentlemen, thank you for standing by. Welcome to Compugen's First Quarter 2019 Results Conference Call. (Operator Instructions) 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.

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Elana Holzman, Compugen Ltd. - Director of IR & Corporate Communications [2]

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Thank you, operator. 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 or other forward-looking statements regarding future events or future business outlook, anticipated progress on Compugen's pipeline programs and financing-related matters as well as statements regarding its corporate restructuring and anticipated reduction in expenses and cash savings. 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 March 21, 2019. The company undertakes no obligation to update projections or forward-looking statements in the future.

I will now turn the call over to Anat.

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Anat Cohen-Dayag, Compugen Ltd. - CEO, President & Director [3]

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Thank you, Elana. Good morning, and good afternoon, everyone. I would like to welcome you to our first quarter 2019 corporate and financial update. As Elana mentioned, with me today are Dr. Henry Adewoye, our Chief Medical Officer, who will update you on our COM701 Phase I clinical study; and Ari Krashin, our CFO and COO, who will review our financials.

On today's call, I will discuss the progress we have made during 2019, which continues to be marked by strong execution and positive development. We continue to be encouraged by the advances made in the Phase I study of COM701, our leading immuno-oncology candidate, and we anticipate reaching additional key milestones in the second half of the year. In parallel, we also continue to invest in the company's long-term value drivers. These are our innovative earlier-stage immuno-oncology pipeline to follow behind COM701 and COM902 and our computational discovery capabilities, which are focused on addressing key challenges in the field of immuno-oncology.

Turning to COM701. We are very pleased with the execution thus far of our Phase I trial. The monotherapy dose escalation arm is advancing on schedule and we expect to complete enrollment by the end of the third quarter. The completion of this stage will allow us to begin enrolling patients in the monotherapy expansion cohorts later this year.

Based on the progress we have made in the COM701 monotherapy dose escalation arm, we recently dosed the first patient in the combination arm of the study in which we are evaluating escalating doses of COM701 with a fixed dose of Opdivo, Bristol-Myers Squibb PD-1 inhibitor. The combination arm of our study are conducted under the clinical trial collaboration with Bristol-Myers Squibb, which we announced last October. We expect to complete enrollment for this arm of the study this year.

Our Phase I trial is receiving considerable interest from the trial's investigator. This has enabled us to add new leading medical centers and high profile immuno-oncology investigators, reaching to a total of 10 centers. We believe this interest stems from the fact that the COM701 program, the only anti-PVRIG inhibitor currently in clinical testing, is backed by solid scientific rationale as is the biomarker strategy and drug combination approach, which is not prevalent among many other immuno-oncology combination trial.

In addition, we recently strengthened our intellectual property position with respect to COM701 with 2 new U.S. composition of matter patents covering COM701 and any anti-PVRIG antibody having CDRs of COM701, which are the fragments of COM701 antibody that specifically binds to PVRIG known as complementarity determining regions. These 2 composition of matter patents provide exclusivity on COM701 in the United States for any purpose and expand Compugen's intellectual property protection for COM701 beyond the therapeutic use patent we received in 2017. We are pursuing additional patents in the U.S. and elsewhere to further broaden our intellectual property position for our lead program.

And now turning to COM902, our next most advanced program, which is on track for an anticipated IND filing later this year. Our plans to advance this program to the clinic are still being formulated based on the competitive landscape and our plans under the Bristol collaboration. We will update you about our plans as these will be formulated.

While COM701, our near-term value driver, continues to advance, we are at the same time advancing our long-term core value drivers, our early stage immuno-oncology pipeline and proprietary computational target discovery infrastructure. These 2 core value drivers of the company are focused on identifying new therapeutics for patients who are refractory to current cancer immunotherapies or are relucting following such treatments. These patients represent the majority of patients across all cancer indications.

As with our COM701 program, our earlier-stage pipeline and ongoing discovery efforts are aimed to address this significant medical need. Our earlier-stage pipeline is focused on novel targets, modulating the immunosuppressive cells in the tumor microenvironment with the goal of targeting the immune inhibition processes occurring within the tumor microenvironment. These programs are addressing mainly immune cells from the myeloid lineage which possess strong immunosuppressive environment. Targeting such immune cells may inhibit the immunosuppressive mechanism and offers the potential for efficacy in patients with cancers not responding to current cancer immunotherapy.

We are working on a number of target candidates within our early-stage pipeline, performing various studies to allow for the selection of drug targets that we believe have the best potential to serve for the development of first-in-class cancer immunotherapy drugs. We are fortunate to have the dedicated support of our highly engaged SAB members who are key leaders in the immuno-oncology field to help us advance and prioritize our programs in this highly complex field of myeloid biology.

As these are early-stage programs, we have opted not to disclose these drug target programs. We believe in obtaining a thorough scientific understanding of these candidates with respect to their ability to serve for the development of cancer immunotherapy drug as we did for PVRIG and COM701. We will share more information on these programs as the science behind them deepen, when we have a robust package for preclinical development and when we feel it is the right time to do so in terms of the competitive landscape.

As for our discovery efforts, we have recently expanded these to include the discovery of drug target involved in driving mechanisms of immune resistance to PD-1 blocker. In many cases, anti-PD-1 antibodies are rendered ineffective due to the patient developing adaptive immune resistance following treatment. Therefore, with the increased use of PD-1 blocker in various cancer indications, we are starting to see many patients relucting following treatment.

Discovering new therapeutic solutions for these patients has become an area of high interest with extensive competition, but with no breakthrough so far. To this end, we are in the process of developing a new discovery platform to identify proteins and pathways which are driving immune resistance mechanisms to PD-1 therapy.

With the platform, we attempt to overcome certain challenges in the field, namely the limited publicly available data derived from cancer patients with clinical annotation as to their PD-1 response as well as the subtle molecular signals seen in many analytical approaches differentiating responders and nonresponders to PD-1 treatment. We aim that the new platform in development will provide us with new insight into such immune resistance mechanisms to enable the discovery of new potentially worthy drug targets. We will provide more information about this platform as we progress.

With COM701 progressing towards clinical data and COM902 nearing the IND filing, our goal is to generate a substantial pipeline to ensure we have additional high-potential assets following behind these 2 programs, both for internal development as well as for additional partnering opportunities on top of the 2 programs being advanced by our partners, Bayer and AstraZeneca. As such, we remain committed to our strategy and continue to pursue collaborative arrangement for our programs at various stages of development.

At this time, I'd like to take this opportunity to thank Kirk Christoffersen for his contributions while at Compugen and wish him much success as he decided to pursue a new opportunity. We are in the process, supported by the network and experience of our Board members, of finding the right person to lead our business development activity and expect to successfully complete this soon.

With that, I would like to turn the call over to Henry for a more detailed update on the COM701 trial. Henry?

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Henry Adewoye, Compugen Ltd. - Chief Medical Officer [4]

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Thank you, Anat, and good afternoon and good morning to everyone. Our team has remained focused and worked very diligently to execute on our clinical development strategy over the last several months, and I am very pleased to share good news and positive developments with you.

First, the ongoing Phase I clinical trial remains on track with enrollment of patients and opening of new clinical trial sites. In the first 5 months of the year, we added several new sites, all leading centers with extensive experience in conducting oncology clinical trials in general and in the field of immuno-oncology in particular. In total, we now have 10 sites participating in the study. These new sites include Columbia University, MD Anderson Cancer Center, Cleveland Clinic, University of California, Los Angeles and START Midwest. Having these 10 sites participate in our study going forward will help us meet our patient enrollment projections for the dual combination arm and expansion cohorts.

Secondly, there's keen interest and engagement by all the investigators involved in the clinical trial, including thought leaders in the field of immuno-oncology. This is understandable. As you're all aware, there's a high unmet medical need for novel agents for the treatment of patients with cancer who suffer a relapse following the treatments with currently approved checkpoint inhibitors or checkpoint inhibitors undergoing clinical testing. Our expectation is that our ongoing Phase I clinical trial with COM701 will hopefully meet that need.

Thirdly, our publication strategy to inform and educate our shareholders and members of the health care and scientific community remains on track. So far this year, we have presented 2 posters under the Trials in Progress category at 2 scientific conferences, the ASCO-SITC Clinical Immuno-Oncology Symposium in San Francisco in January and the AACR Annual Meeting in Atlanta, Georgia in early April.

While no clinical data were presented in keeping with the guidelines of these conferences, we provided information on the status of the ongoing Phase I clinical trial, the COM701 monotherapy dose escalation study and disclosed that we had observed no dose-limiting toxicities in the trial. In our last Trial in Progress poster presentation at AACR, we disclosed that the fifth dose level patient cohort of COM701 monotherapy has been completed with no dose-limiting toxicities reported. We also disclosed that clinical and laboratory assessment for safety and tolerability are ongoing for this and earlier dose level patient cohorts. Enrollment of patients into this arm of the study is ongoing and, as Anat mentioned, we expect to complete enrollment soon.

As COM701 is a novel first-in-class checkpoint inhibitor of PVRIG, our TIP presentations drew a significant audience at these scientific meetings. Our next TIP presentation is scheduled at the 2019 ASCO Annual Meeting, which will take place in Chicago in the next few weeks. Our poster presentation is scheduled for June 1.

As Anat has mentioned, we recently initiated the combination dose escalation arm of the study in which escalating doses of COM701 will be combined with a fixed dose of Opdivo using a 3 plus 3 study design. As previously indicated, we project completion of this arm of the study later in the year and plan on providing periodic updates through Trial in Progress abstract presentations at scientific conferences. As a reminder, the combination arms of this ongoing Phase I study is sponsored by Compugen in collaboration with Bristol-Myers Squibb.

In the second half of 2019, we project initiating enrollment of patients in the COM701 monotherapy dose expansion cohort at the recommended dose of COM701 monotherapy based on the clinical and laboratory data from the dose escalation arm of the study. The expansion arm will enroll patients with relapsed lung, ovarian, breast and endometrial cancer.

As we have previously disclosed, these tumor types were selected based on our preclinical data demonstrating high expression of PVRL2. COM701 inhibits PVRIG and its interaction with PVRL2, a member of the DNAM AXIS, leading to activation of T-cells in the tumor microenvironment, generating an antitumor immune response leading to tumor growth inhibition.

There's still a lot of work to be done on behalf of patients as we at Compugen and the clinical investigators advance this clinical trial. The good news is that Compugen is up to the task and we will remain focused on the execution of our clinical trial strategy.

I look forward to seeing you in the next few weeks in Chicago at our poster. My sincere thanks to all our patients, family members and investigators who have been instrumental to the progress of this clinical trial. We are excited about our ongoing clinical trial and the collaboration with BMS and look forward to sharing with you more good news and positive developments in the coming months ahead.

I'll hand the call over to Ari.

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Ari Krashin, Compugen Ltd. - Chief Financial & Operating Officer [5]

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Thank you, Henry. Good morning and good afternoon to everyone.

Our financial results for the first quarter of 2019 released this morning reflect the initial effect of the restructuring process we underwent at the end of the first quarter. The reduction in expenses will continue over the course of 2019 with the full effect of the savings expected to be reflected in 2020.

As of March 31, 2019, we had approximately $38 million in cash and cash-related accounts compared with approximately $46 million at the end of 2019. Our total cash expenditures for the full year of 2019 are expected to be in the range of $27 million to $29 million. This amount includes estimated restructuring-related expenses of up to $1.5 million over the course of 2019.

Our R&D expenses for the first quarter of 2019 decreased by 10% and totaled $6.3 million compared with $7.1 million in the comparable period of 2018. The reduction was offset by expenses associated with the progress of our ongoing Phase I trial. R&D expenses for the fourth -- for the quarter also reflect approximately $0.4 million of restructuring-related expenses.

General and administrative expenses for the first quarter of 2019 decreased by 6% and totaled approximately $2 million compared with approximately $2.1 million in the comparable period of 2018.

During the first quarter of 2019, we had a net loss of approximately $8.4 million or $0.14 per basic and diluted share compared with the net income of $0.1 million or $0.00 per basic and diluted share for the comparable period of 2018. The net income in the comparable quarter of 2018 was attributed to the revenues in the amount of $10 million from the license agreement with AstraZeneca during that quarter.

Before ending my prepared remarks, I would like to note that we remain committed to allocating the necessary internal resources to the planned expansion of the ongoing Phase I study for COM701 as well as advancing our other programs. We expect that the overall reduction in our expenses will enable us to become a more financially stable company with sufficient cash resources through mid-2020.

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

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Questions and Answers

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Operator [1]

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(Operator Instructions) The first question is from Mark Breidenbach of Oppenheimer.

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Mark Alan Breidenbach, Oppenheimer & Co. Inc., Research Division - Executive Director & Senior Analyst [2]

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Just -- first of all, congrats on getting the combination dose escalation cohort started. A couple of questions on that. Are you expecting most of these patients to have previous PD-1 exposure? Or are you expecting most of them to be PD-1-naive?

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Anat Cohen-Dayag, Compugen Ltd. - CEO, President & Director [3]

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Henry, would you take this question?

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Henry Adewoye, Compugen Ltd. - Chief Medical Officer [4]

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Yes. Mark, glad to take the question. So we think -- we project we'll have a mixture of both kinds of patients, both previous treatments with PD-1 inhibitors and patients who've relapsed or patients who are actually naive with treatments with PD-1 inhibitors.

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Mark Alan Breidenbach, Oppenheimer & Co. Inc., Research Division - Executive Director & Senior Analyst [5]

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Okay. And are you looking for any particular efficacy threshold before advancing into the dose escalation cohorts -- I'm sorry, the dose expansion cohorts, both in monotherapy and the combination dose expansion? Or would the decision to move forward into the dose expansion cohorts purely be based on safety?

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Henry Adewoye, Compugen Ltd. - Chief Medical Officer [6]

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Yes. Mark, that's a very good question. So for the purposes of this Phase I clinical trial, the decision to go into the expansion cohorts will solely be based on safety.

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Mark Alan Breidenbach, Oppenheimer & Co. Inc., Research Division - Executive Director & Senior Analyst [7]

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Got it. Got it. And finally, I know there was the possibility of Bristol-Myers Squibb running a triplet combination with its anti-TIGIT antibody in addition to COM701 and Opdivo. Are you -- do you have any updated indication or clarity from Bristol-Myers what their timing might be like in terms of getting that trial started? What would they want to see from your dual combination data maybe before testing a triplet combination?

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Anat Cohen-Dayag, Compugen Ltd. - CEO, President & Director [8]

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So Mark, we cannot say a lot about that Bristol collaboration. The only thing is that we are reinforcing the interest of the 2 companies. They are aligned and that -- obviously, the strategies of how to address this alliance, but we cannot say more than that and give more details about this collaboration.

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Mark Alan Breidenbach, Oppenheimer & Co. Inc., Research Division - Executive Director & Senior Analyst [9]

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Okay. You can't even tell me if you expect that to potentially start this year or next?

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Anat Cohen-Dayag, Compugen Ltd. - CEO, President & Director [10]

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No. We cannot relate to time lines at all at this stage.

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Operator [11]

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The next question is from Ted Tenthoff of Piper Jaffray.

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Edward Andrew Tenthoff, Piper Jaffray Companies, Research Division - MD & Senior Research Analyst [12]

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So I want to kind of go back to the platform a little bit and then just a high-level question, if I may, with Bayer. So with respect to kind of all of the emerging targets, how do you really prioritize? I mean, this may be a bigger question, but at a high level, how do you prioritize which targets to pursue and really how they work in combination with others?

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Anat Cohen-Dayag, Compugen Ltd. - CEO, President & Director [13]

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It's a very good question. In general, we relate to 3 different buckets. The first bucket is the distant checkpoints that we decided to focus on is the PVRIG obviously, the ILDR2 that was licensed to Bayer and the TIGIT.

The second bucket is myeloid and when we are -- as I mentioned in the call, when we are looking at prioritization, it really relates to the science, the drug ability in terms of these proteins not only function as proteins that would inhibit immunosuppressive processes within the tumor microenvironment, but also would they serve as good drug target, and that's a whole different story, which obviously, all over the world, the success is very low. And that's the second bucket.

And the third bucket is what I mentioned today. These are -- this relates to new platforms that will actually address next wave, which we believe would be the next wave. So that -- and each gets its own resources in the company, but obviously we have periodic analysis internally in the company of all the programs in the company alone, I mean, the management and the managers in the company, but also with the Scientific Advisory Board and obviously clinical advisory committee.

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Edward Andrew Tenthoff, Piper Jaffray Companies, Research Division - MD & Senior Research Analyst [14]

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Okay. That's helpful. And then at a high level, just with Bayer and the headlines all the time because of this ramp-up stuff, have you sensed a loss of focus? Or how are things progressing from the Bayer pharma side?

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Anat Cohen-Dayag, Compugen Ltd. - CEO, President & Director [15]

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Yes. So obviously, I'll leave it to Bayer to comment on their organization and restructuring, but from our perspective, this program is moving forward. Bayer is committed to this program, investing resources. We're getting periodic update about the status of the program. So we're happy with the collaboration.

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Operator [16]

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The next question is from Lucy Codrington of Jefferies.

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Lucy-Emma Mary Sarah Codrington-Bartlett, Jefferies LLC, Research Division - Equity Analyst [17]

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Just a quick one about -- you mentioned 902 that you'd be watching the competitive landscape for kind of deciding how to proceed with the program. I just wondered if there are any particular programs that you are watching that will influence your decision?

And then secondly, is there anything that you expect to see at ASCO that could perhaps influence go or no-go decisions for the earlier-stage pipeline?

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Anat Cohen-Dayag, Compugen Ltd. - CEO, President & Director [18]

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Yes. It's a very good question, Lucy. And -- so with respect to COM902, I did say that it is on track for IND filing and that we're formulating our plan forward. When I was referring to the competitive landscape, it's actually relating to 2 different aspects. One, obviously we don't want to follow -- first, I'll remind this program really in our pipeline in order to complement COM701, and that's the first goal for this program. But having said that, obviously this is near IND filing. It is going to be soon a clinical-stage asset and, in that respect, we cannot ignore the fact that it has -- it may have its own potential as a clinical-stage asset even not relating to COM701.

So when we look at the competitive landscape, on one hand, we do not want to follow others and just join the rest of the crowd. There is -- there are a lot of clinical-stage assets as well as there are preclinical-stage assets. And basically, I'm not referring to any specific company. We look at all competitive assets and we look at how they decide to move ahead their programs and how they pursue this opportunity. That's one aspect of the competitive landscape. And the other one is our own data. Obviously, we have our own preclinical data on COM902. Part of it is how we keep supporting a combination of COM701, but the other part is having insights about targeting TIGIT in general. So we are trying to understand how we should move ahead. And yes, I didn't mean any specific company, but as a whole, the competitive landscape.

And when you were asking the question about programs at ASCO, you meant with respect to TIGIT or any other programs? I didn't get your question, sorry.

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Lucy-Emma Mary Sarah Codrington-Bartlett, Jefferies LLC, Research Division - Equity Analyst [19]

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Yes, TIGIT and to be honest, all the pipeline, but with the appreciation there -- the targets aren't being disclosed.

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Anat Cohen-Dayag, Compugen Ltd. - CEO, President & Director [20]

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So obviously, you probably understand that we are having a lot of interest in understanding the clinical data that is being published, the one that was published at SITC and in any additional conferences going forward, including ASCO. That, on one hand, allows us to verify our assumptions with respect to COM902-COM701 combination or better say TIGIT-PVRIG combination, but also, as I said, for the program on its own and it's competitive landscape. So yes, for sure.

With respect to other programs, you were asking the question about ASCO, but I have to say that, as a company, it has discovery capabilities and discover new programs. We are always on top of what's going on in the industry with new programs and the data that is being disclosed. It is a very important piece of information for us to make decisions. It is even complementary to what Ted was asking me with respect to how we prioritize. That's one of the parameters as to how we prioritize. I will not say that if we see that there is a certain asset that is being advanced by another entity, we will give up on this. It doesn't mean that we'll give up on this, but it may be -- it will be factored into our decisions and whether we're differentiated and how early or late just compared to these assets we are. So yes, definitely at ASCO, we are -- we usually have teams in these conference sets and we take care to learn about what's going on in the industry.

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Operator [21]

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

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Anat Cohen-Dayag, Compugen Ltd. - CEO, President & Director [22]

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Thank you, operator.

2019 continues to be marked by strong execution. We successfully added 7 sites to our study in 2019 and now have 10 leading sites participating in our study. The monotherapy dose escalation arm is advancing as planned and we expect to complete enrollment by the end of the third quarter, which will be followed by initiation of the expansion cohort. We recently dosed the first patient in the combination dose escalation arm of this study and we expect to complete enrollment in this arm later this year. In parallel, we are also advancing our early stage programs and expanding our discovery effort. We are very pleased with the progress of our COM701 Phase I study and I hope to be able to share with you additional time lines later this year.

Thank you all for joining us today and I look forward to continue updating you on our progress throughout 2019. Thank you.

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Operator [23]

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Thank you. This concludes the Compugen Ltd. First Quarter 2019 Financial Results Conference Call. Thank you for your participation. You may go ahead and disconnect.