Earnings Labs

Compugen Ltd. (CGEN)

Q3 2017 Earnings Call· Tue, Nov 7, 2017

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Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing by. Welcome to Compugen's Third Quarter 2017 Results Conference Call. At this time, all participants are in a listen- only mode. An audio webcast of this call is available in the Investor 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.

Elana Holzman

Management

Thank you for joining us today. With me from Compugen are Dr. Anat Cohen-Dayag, President and CEO; and Ari Krashin, CFO and COO who will provide quarterly updates. Dr. John Hunter, Vice President, Antibody R&D and Head of our USA is also joining us from San Francisco and is available to answer questions. 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, anticipated progress on Compugen's pipeline program as well as business development efforts and financing related matters. 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 that the company filed with the Securities and Exchange Commission including the company's most recent Annual Report on Form 20-F, filed February 16, 2017. The company takes no obligation to update any projections or forward-looking statements in the future. I will now turn the call over to Anat.

Anat Cohen-Dayag

Management

Thank you, Elana. I would like to welcome everyone to our quarterly earnings update. I will focus in my prepared comments today on the progress we have made during the last quarter with respect to our pipeline program, the development path and potential impact both on the company and the cancer immunotherapy field. Ari will follow with a review of key aspects of the financial results released earlier to date. As Elana mentioned, Dr. John Hunter, our Vice-President antibody R&D and Site Head of Compugen USA is also on the line and will be available for the Q&A session. I’d like to begin by saying how please we are that Paul Sekhri has joined Compugen competition as our new Chairman of the Board of Directors. Paul has spent over 30 years in the life sciences industry with both big pharma and smaller biotech’s and brings exceptional experience both in the US and aboard. We're confident that his leadership and experience would be invaluable for Compugen as we transition to a clinical stage company and Paul's prospective and guidance will help us enhance and extract the commercial value of our pipeline program and unique discovery capabilities. Regarding our lead R&D program, we are continuing to make key advancements including for first-in-class immune oncology anti-PVRIG candidate COM701. We remain on track for filing an IND for COM701 towards the end of Q1, 2018. For this program as well as for our earlier stage immune oncology program and CGEN-1501 for autoimmune diseases we continue to hold discussions with the potential industry partners and we remain confident this will really achieve multiple collaboration. Nonetheless, we cannot predict the exact timing of completing any such collaboration as most of our programs are novel and early stage entailing a lengthy evaluation period by prospective partners and…

Ari Krashin

Management

Thank you, Anat. While you may find the full details of our financial results in the press release issued this morning, I will now provide a summary of the highlights. Net loss for the third quarter of 2017 was $9.9 million or $0.19 per diluted share compared to a net loss of $7.8 million or $0.15 per diluted share for the third quarter of 2016. As we have developed our pipeline and moved forward our first anticipated IND filing, research and development expenses continues to be our single largest category of expenses totaling $7.6 million for the third quarter of 2017 compared to $6 million in the third quarter of 2016. These expenses continue to reflect an increase in preclinical development activities including manufacturing an IND enabling costs related to the COM701 program as well as increased activities related to COM902. Total cash expenditure for the full year of 2017 are expected to be approximately $34 million assuming approximately $9 million of cash expenditures for the fourth quarter of 2017 excluding potential cash impact. In the September 30, 2017, we had approximately $38.5 million in cash and cash related accounts with no debt. As a policy, management and the board periodically evaluate the company’s cash status in light of these development plans, business activities, financing opportunities and market condition. This is considered together with the long-term best interest of our shareholders. Strengthening our balance sheet continues to be a top priority for management and the board. Entering into new collaborative arrangements as well as milestone payments under existing or new collaboration would clearly impact our cash balance in path forward. Any future decisions regarding possible financing will take into consideration all of these factors as they exist at such time as well as the resources needed to ensure a clear path to becoming a development stage company. Thank you. And with that, I will now open the call for questions.

Operator

Operator

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

Michael King

Analyst

Hey guys, good afternoon, good morning. Thanks for taking the question. I wanted to just ask you more of a high level question about sort of the IO landscape as it is evolving right now and how that may impact your thinking about how you develop your clinical candidates, and it just it seems like the combination world things that are going on top of checkpoints are getting a lot more complicated, the readthroughs from animal studies are less reliable, the impact that combination therapies are having on the activity of checkpoints namely PD-1 inhibitors is not as clear cut as some may have assumed. So I’m just wondering how this new evolving data has caused you to perhaps rethink or adjust your development strategies for things like 701, 902 et cetera?

Anat Cohen-Dayag

Management

Sure. Thank you, Mike. And in general, if you were relating to few of the trends now that are occurring in the IO field but I will take it as a high level person and related. I can say that but going on currently in the IO field is serving both as challenges but also opportunities for Compugen. And we follow up on this periodically and make sure that we are aligning the path forward. And so just with respective checkpoint and so, yes, the checkpoints that were tested in the clinic and most of them did not show competent with initial data, did not show compelling data; there is a data for last three is opening the door to maybe add on the PD-1 response rate and it’s posing challenges there. We need to show that the PVRIG checkpoints and the pathway of PVRIG TIGIT, as I explained, is going to make a difference and we’re committed to test it in the clinic. But on the other and the fact is there is one there it showing a path forward, as I stated last week, is encouraging. So that's with respect to the checkpoint. Translating the data and by the way with respect to other trends in the industry [indiscernible] becomes more -- get more recognition I think that it is clearly also affected our decision to get into the myeloid biology field and to make sure that we diversify the pipeline with respect to different mechanism of action to address the resistant patient population -- the drug resistant patient population. With respect to animal studies actually this is something that we're taking into consideration when in designing the clinical trial. We have certain data that are actually pointing to specific type of indication as I commented in my remarks today. But it is not clear that these will be the indications they're going forward that will be validated clinically. And it could well be that other indications that are not popping up now at the preclinical stage will be seen as relevant. And just one way to incorporate this gap between preclinical data and clinical data was actually for us pointing in fact that we should go ahead within all-comer trial and nothing what we see in the preclinical package and yet to slight focus on specific indication but actually go ahead with an all-comer trial. So we can see clearly the different type of indication as they are, as the data is going to come out of the trial. That’s all. Since John is located in the different site, I'm now in New York and John is in San Francisco. I'll just ask John whether he has anything to add on this. John?

John Hunter

Analyst

Yes, and the one thing I would add on top of that is that we are trying to do as much bio marker work is possible to really better understand which patients we want to target both with COM701 and COM902 because we think there's going to be a critical component of the development strategy.

Michael King

Analyst

Okay, fair enough. And then perhaps related to that I just wonder not if the you guys are, I guess, less convinced that corporate collaboration deal can get done this year. And I just wonder if you feel that is reflective of sort of this I don't want to call it turmoil but just sort of we're in a bit of a graze on right at the moment in the world of IO define that potential corporate collaborators are more conservative at the moment, maybe there is some deal fatigue or is it perhaps something to do with sort of the state of development, are they looking for assets that have more maturity perhaps proof of concept in humans rather than as you point out in your former remarks of the pre-clinical evidence of activity? Thank you.

Anat Cohen-Dayag

Management

It's a very good question. I wouldn't say that there is a fatigue out there. Of course people are looking in the IO field and now on different methods that they would probably look at four years ago. And because we know more and we also know that we -- as much as we know we don't know enough generally in this field, but I think -- but, you know, for Compugen we have different aspects that are in discussion with different stages and of development. So we thought really about the specific stage, everything that we have in the pipeline is still early not till it gets to the clinic and we have clinical data completely considered as early. situation:

Michael King

Analyst

Thank you.

Operator

Operator

The next question is from Ted Tenthoff of Piper Jaffray. Please go ahead.

Ted Tenthoff

Analyst

Great. Thank you very much and thanks for the update. We have to elaborate certain questions. I just wanted to follow-up with sort of the primary programs. Again, I think what you're doing with PVRIG and TIGIT is very interesting and novel, but there is more competition there. Myeloid it seems like you're closer to sort of where everybody is. So what should we be expecting from that and are these novel targets or these target that may be known to other players?

Anat Cohen-Dayag

Management

These are novel targets and it could be that some of them are known rather a partners who don't exactly know what is in the pipeline of other before they publishes. But these were discovered through our computational discovery capabilities in novel target very early stage in different stages of the validation and antibody discovery. In general, the data packages as of this point are not -- as I said these are in validation, so they are not in complete data packages. But yes, as we stated this is in early fears in general in the industry and we're more or less up to the stage of the rest of the industry. And one more point just to make, there are several clinical stage programs, Myeloid programs that are moving forward by others and this is what considers the first wave of things, Myeloid programs in the industry.

Ted Tenthoff

Analyst

[indiscernible] 0:03:19:

Anat Cohen-Dayag

Management

Thank you.

Operator

Operator

The next question is from Peter Welford of Jefferies. Please go ahead.

Peter Welford

Analyst

[indiscernible]?:

Anat Cohen-Dayag

Management

Okay, yes. John, would you like to take the first one with respect to the PD-1 treated patients?

John Hunter

Analyst

Sure. Yes. So because this is going to be an all-comers trial and different indications, we do expect that some of the patients will have been treated with and have failed on other IO therapies but it's really going to depend on which indications that we're treating and what the standard of care is within those indications. Regarding the choice for PD-1 antibodies versus PDL-1, right now our feeling is that the PD-1 antibodies have a slight edge in the clinics from the data that we've seen, so that's where our focus is for the combination.

Peter Welford

Analyst

Great. And then if I could just follow-up on the Bayer collaboration. I appreciate it's maybe difficult to comment. But do you have any sort of update on 5000 1P, I guess, as far as how that's progressing with Bayer and then if you could sort of update on that? Thank you.

Anat Cohen-Dayag

Management

Sure. So just in general, under the collaboration we are very much restricted with sharing information. From time-to-time, we conduct the process with Bayer in order to for them to approve specific information than we're going to share with investors. Of course, we're very much into the details of the programs internally as Compugen together with Bayer, but information that we can share in with investors, this is process that we do with Bayer from time-to-time. So as of today, the information that we can share with respect to these programs is that it is moving to the clinic by Bayer and -- but we cannot share more information as to the exact timeline for IND filing or as such, so I'm sorry for being short on this.

Peter Welford

Analyst

That's great. Understood. Thank you.

Operator

Operator

This concludes the 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 statements?

Anat Cohen-Dayag

Management

Thank you operator. Before ending, I would like to summarize the main highlights discussed on today's call. We continue to hold discussions with potential industry partners in connection with our program and we remain confident that we will achieve magical collaboration. Nonetheless, we cannot predict the exact timing of completing any such collaboration. Our pipeline programs continue to advance with COM701 being on track for an IND filing towards the end of Q1 2018 and we are working on finalizing the clinical protocol for our plan Phase I study. We expect to enter the clinic in 2018. COM902 is moving into process development and manufacturing with the goal of filing an IND for combination trial with COM701 in 2019. I would like to thank you all for joining us today and I look forward to sharing with you additional information as we progress. Thank you.

Operator

Operator

Thank you. This concludes the Compugen Ltd. third quarter 2017 financial results conference call. Thank you for your participation. You may go ahead and disconnect.