Earnings Labs

Compugen Ltd. (CGEN)

Q4 2017 Earnings Call· Wed, Feb 21, 2018

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Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing-by. Welcome to Compugen's Fourth Quarter and Full Year 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 at 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, operator. Thank you for joining us today. With me from Compugen are Dr. Anat Cohen-Dayag, President and CEO; and Ari Krashin, CFO and COO and Dr. John Hunter, Vice President, Antibody R&D and Head of our USA. 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 program 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 filed by the company with the Securities and Exchange Commission including the company's most recent Annual Report on Form 20-F, filed February 16, 2017. The company undertakes 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 fourth quarter and full year 2017 earnings update. In my prepared comments today, I will provide an overview of our key achievements in 2017 mostly with respect to the various programs in our pipeline. I will also focus on our clinical and biomarker strategy for our lead program COM701, a first-in-class immunoncology anti-PVRIG candidate. John will provide additional detail on our IND enabling study and the upcoming IND filing for COM701 as well as on the preparation for our clinical trials. Ari will close our prepared comments today with the financial update before we open the call for the Q&A session. 2017 was a significant year for Compugen in which we made important progress in advancing our therapeutics pipeline and strengthening our core competencies, both in target discovery and validation and therapeutic antibody development. Today, there are four clinical programs originating from our discovery capabilities that have showed for clinical proof of concept. In addition to our preclinical pipeline, we also established an earlier stage pipeline focused on early target and newly arising and promising field in cancer [ph] immune therapy. This early stage pipeline is designed to feed our preclinical pipeline with additional program and to diversify our drug opportunities Our pipeline strategy is to leverage our computational discovery capability to address diverse mechanisms of action, that which the immune systems interacts with the cancer. Targeting new pathways of interactions between the immune system and the cancer may address the tremendous clinical gap in cancer immunotherapy, in which 70% to 80% of the patients do not respond to approved cancer immunotherapy drug or develop resistance to these treatments overtime. To enhance our exploration of new biological pathways in cancer, we augmented our in-house R&D infrastructure by entering into…

John Hunter

Management

Thanks Anat. As Anat mentioned, I’ll be updating you on our progress with COM701 IND enabling activity as well giving a high-level overview of our planned Phase 1 clinical trial and our preparations to that trial. Regarding the manufacturing of the drug itself, we have established a master sale bank that expresses COM701 as greater than six grams per liter in the bioreactors allowing us to produce an up-drug substance in our recent GMP manufacturing run who will meet our near term clinical needs. We have bio-sufficient drug substances that generate ample amount of drug product for Phase 1 clinical use. The drug product is released in January on schedule and recently passed the one-month stability testing required prior to IND filing. The only remaining step prior to clinical use of this drug product is the labeling of the drug vials is planned to be completed in March. On the IND labeling front, the GMP toxicology study has been completed and the reports from the study are being incorporated into our IND filing. Results from the study were unremarkable with no definitive drug related findings with doses up to 100 mgs per day. We were also able to use data from the non-GMP and the GMP toxic study, the model we expected pharmacokinetics, pharmacodynamics COM701 and [indiscernible] providing some insight into our target testing level and the schedules for the file. Based on PK modeling we plan to dose COM701 every three weeks in the clinic which is fairly typical for an antibody therapeutic. Having completed manufacturing and IND enabling activities, our current focus is on the writing and submission of the IND. In anticipation of this, we had a written response only pre-IND meeting with the FDA last October to align expectations and to get their feedback on the…

Ari Krashin

Management

Thank you, John. Our financial results for the fourth quarter and full year 2017 [indiscernible] are in line with our expectation. In general, we continue to reflect the increase in preclinical development activities, including costs associated with manufacturing and IND-enabling studies of COM701 in preparation for the IND for the filing of an IND applications at the end of Q1 2018 as well as increased activities related to COM902 and top of the other programs in our pipeline. As previously forecasted, our total cash expenditures during 2017, amounted to approximately $34 million. For 2018, as we plan to start our Phase 1 trial of COM701 and the IND-enabling studies of COM902, we expect the total growth cash expenditures will be in the range of $38 million to $40 million. Our R&D expenses continue to represent approximately 80% of our overall budget in 2018 and the level of expenses for development activities represents about two-thirds of the total R&D expenses. This increase in our development expenses continue to reflect our strong commitment with this pipeline with the clinic and becoming a clinical stage company in 2018. Now turning to our 2017 financial results, R&D expenses during 2017 increased by 70% and total $28.6 million compared with $24.5 million in 2016. For the first quarter of 2017, R&D expenses was $7.2 million compared with $6.3 million in the comparable period in 2016. The increase in both cases, as mentioned earlier reflect activities around the COM701 and COM902. These activities include toxicology studies, manufacturing costs and other related expenses. General and administrative expenses during 2017 remains approximately at the same level in 2016 and total $7.6 million compared with $7.4 million for the full year and $1.9 million in the fourth quarter of 2017 compared with $2 million in the comparable period of…

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.

Mike King

Analyst

Hi, good morning, and good afternoon guys. Thanks for taking the question. I wanted just to ask about patient samples that you referenced looking at PVRIG expression, PVRL2, I just wanted to know if you expect to and present the correlation studies there, can we expect to see those presented at whatever AACR or some other scientific conference this year because I think we've certainly love to see what the profile looks like. And also wanted to asking conjunction with that, if in addition to looking for immuno dominance as you did, whether you are able to ascertain whether tumor mutation burden played any role in its expression?

John Hunter

Management

Hey, Mike, this is John. The samples that we have looked at to-date, we get through a cooperative, so they are not from trails where we have a lot of data, they are available for fresh tumor samples. We actually presented some of that data publicly. We have a keystone poster that I would refer to you -- refer you to this on our website. And we are continuing to look at a broader sample set and we'll continue to roll that data out probably over the next couple of quarters as we accrue it. Just with regards to looking at tumor mutation burden, we have not really look deeply into that yet. Because again the samples that we're getting are kind of from different sources. We are looking at academic collaborations where we have more dedicated sourced samples. And that will be something we can view as we continue to get those collaborations up and running.

Mike King

Analyst

Okay, all right. Thanks for the color on that. I wanted to also ask about the financial situation. You guys are starting to run a bit low, $30 million at the end of the quarter. What types of steps do you anticipate taking in order to bolter your capital resources? Thank you.

Ari Krashin

Management

Hey Mike, it's Ari. So basically, just small repeating one, as I said earlier. One of the year with the possibility of $50 million. The cash expenditures for the year estimated to be between $38 million to $40 million. So clearly there is a gap to bridge. But any decision that we will take regarding our cash we'd just need to take into consideration. The various factors including our development plans, potential milestones, market rate condition, and we'll take it...

Mike King

Analyst

Ari, can you talk about so people got maybe perhaps a better understanding of are there any other upcoming milestones that might be available to you, let's say? To Bayer would they pay you let's say milestone upon commencement of clinical trials presuming that they eventually get to that point?

Ari Krashin

Management

So again, as we also mentioned in the press release, Bayer are planning to present additional data in upcoming conference. Unfortunately, as you know by now, we are not allowed to share the much information about them. But typically, it's industry stand out and for that, we cannot elaborate any further.

Anat Cohen-Dayag

Management

I think Michael, just to add that, of course we stated that Bayer is advancing. And of course, everyone is aware of the fact that we are eligible for additional milestone payments. Of course, we can pay but this is, we are eligible for additional milestones, so this is one source of potential cash inflow. And other source is our potential collaborations. And of course, we are weighing in and reviewing management and the board with the different possibilities, taking into consideration or the different aspects that Ari was relating to in order to make sure that we built this company a clear path to turn into a clinical safe company. So yes, that's the most information that we can share at this stage.

Mike King

Analyst

Okay. Thanks for taking my questions.

Ari Krashin

Management

Thanks, Mike.

Operator

Operator

The next question is from Jordon Santucci of Piper Jaffray. Please go ahead.

Jordan Santucci

Analyst

Hi. Thanks for taking my questions. This is Jordon on for Ted. Progress updated on the call. I have a question on the triple combination study. I understand the clinical strategies reflects for certain tumors based on your PVRL2 expression for the COM701 study. But when you ultimately begin the triple combination risk any digit, how will this change the strategy and evaluation of certain tumors given the data that you discussed regarding the differential expression of PVRIG and across different cancers?

John Hunter

Management

Hi Jordon. This is John. So, in this discussion we focused on tumor types where we see high PVRL2 relative to the under ligand against PVR and PD-L1. But there are a number of tumors and different indications where we see fairly high expression of all the different ligands together with the receptors. And these would be the target population for doing the triple combinations with the rationale that if you are inhibiting any one of those checkpoint pathways in the context where all three are active you’re not going to get a sufficient anti-tumor response, so there are patient samples that we see where we think it would be justified to explore triple combinations because we do think that all of those pathways are active and all of them have to be inhibited in order to maximize the immune response.

Jordan Santucci

Analyst

Interesting. Thanks for the color. Do you think this will present on the data at upcoming conferences this year?

John Hunter

Management

Yeah, there’s sort of snippets in it and some of our existing presentations, but I think again as we move towards the triple combination trials in the clinic we’ll certainly be rolling out data that is really targeted at expanding on that rationale and showing those specific patient population.

Jordan Santucci

Analyst

Great, thank you. Looking forward to it.

Operator

Operator

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

Peter Welford

Analyst

Hi. Thanks for taking my questions. I've got three. Firstly, just on the presentation publications on the ILDR2 with Bayer, I was just wondering that with regards to the autoimmune 15001 programs have the publications triggered any incoming requests I guess or intimation from potential partners or collaborators for that program and have the data I guess triggered in the scientific community and significant interest from potential KOLs? And second that I wondered if you could just give us quick update on 902 manufacturing as where you are with that? And then if I just quick one for Ari can you comment at all on anything about the phasing it’s all of the burn I appreciate you don’t want to give a quarterly guidance but anything at all about how you think the phasing could be during the year? thank you.

Anat Cohen-Dayag

Management

So, I’ll start with the ILDR2 questions, so of course being in the situation where we discover completely new immune checkpoints or better say we link new functions to proteins, we’re doing all the work in-house and with collaborations in order to validate them. Of course, it is different when there is some kind of an external validation from the outside here in this case it comes from a peer reviewed paper too often and thus give a different level of recognition and proof to what we’re doing. So that of course triggers an interest I will of course not share more than that on the business front but for sure this is a proof that get some additional validation at this stage. Needless to say, that these papers were actually showing not only the fact that we discovered the immune checkpoints, but it really has an interesting mechanism affection that could be translated well into first-in-class drug. So that’s on the idea front. I’ll let John respond to the COM902 and CMC with Bayer, John?

John Hunter

Management

Sure. As of now everything is proceeding according to timeline, I don’t think we disclosed to fine detail on this timeline, but we do plan to stay on track with our original 2019 IND filing.

Ari Krashin

Management

Okay. And just to address Peter your last question, generally we assume that the rates during the year will be roughly on an average between 9 to 10 each quarter I guess as we move further along the year without the actual trials. It might increase slightly but I would assume most of the effect of the clinical trial will start in 2019 so 2018 is roughly going to be I would say straight lined more or less.

Peter Welford

Analyst

That’s great. Thank you. Operator The next question is from Mark [ph] of Oppenheimer. Please go ahead.

Unidentified Analyst

Analyst

Hi, thanks for taking the question. This one’s probably geared a little bit toward John, I was hoping you could elaborate on your expectations for the safety profile of COM701 as an interest of clinic for instance have the animal studies hinted that substantially differentiated toxicity between PVRIG and TIGIT inhibitors. And also given that you can knock out PVRIG and [indiscernible] don't have a viable animal, I'm just wondering if you're - if where at all it might take a long time to establish an MTD or recommended to safety dose?

John Hunter

Management

Great. So just with regards to the tox profile. We can't really compare against each inhibitor because the data is not public, and we've done our tox studies with COM902 yet. The data that we have in hand I would say is in line with what we've seen in BLA's filings for other immune checkpoint inhibitors. Again, there was really nothing that remarkable in the studies. But to the second question about actually reaching an MTD. We are aware that we may get to a point in the clinic where we reach a dose that we think should be maximum and we don't want to go beyond it. So, it's not a given that we will get to an MTD in the Phase 1 trial, but we have set a cutoff point where we're confident that we'll have full saturation with the drug and where we don't think it make sense to escalate beyond.

Unidentified Analyst

Analyst

Okay, thanks. That's very helpful.

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 a concluding statement?

Anat Cohen-Dayag

Management

Thank you. This is an exciting time for Compugen. Becoming a clinical stage company this year is an important milestone for the company. With the diversified portfolio based on our discoveries, we believe our pipeline hold a significant clinical and commercial value which will drive our future growth. 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.'s fourth quarter 2017 financial results conference call. Thank you for your participation. You may go ahead and disconnect.