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Compugen Ltd. (NASDAQ:CGEN)

Q3 2012 Earnings Conference Call

November 05, 2012 10:00 AM ET

Executives

Martin Gerstel – Chairman

Dr. Anat Cohen-Dayag – President and CEO

Dikla Czaczkes Axselbrad – CFO

Analysts

Mara Goldstein – Cantor Fitzgerald

Brett Reiss – Janney Montgomery Scott

Klaus Von Stutterheim – Deutsche Bank

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the Compugen Ltd., Third Quarter 2012 Financial Results Conference call. All participants are at present in a listen-only mode. Following management’s formal presentation, instructions will be given for the question-and-answer session. (Operator Instructions)

As a reminder, this conference is being recorded, August 7, 2012. With us online today are Mr. Martin Gerstel, Chairman of the Board, Dr. Anat Cohen-Dayag, President and CEO and Ms. Dikla Czaczkes Axselbrad, CFO.

I would like to remind everyone that the Safe Harbor language contained in today’s press release also pertains to all content of this conference call. If you have not received a copy of today’s release and would like to do so, please contact Dikla Czaczkes Axselbrad at 972-376-585-95. Mr. Gerstel, you canbegin.

Martin Gerstel

Thank you very much. On behalf of my associates, all the employees of Compugen, welcome to our delayed Q3 2012 conference call. Thanks for joining us. First, for those of you and your families who were impacted personally by the devastating storms last week affecting the eastern United States, we hope you are fully recovered or at least are on the way to full recovery and our best wishes are with you.

Less than three years ago, Compugen selected Fc fusion and monoclonal antibody therapeutics for oncology and immunology as our first areas of focus. The results since then, which were largely achieved during the past two years, have been more than impressive and almost certainly unprecedented in the pharma industry and are now conclusively demonstrating to leading companies in the industry the power of the unique, predictive, discovery infrastructure that has been established at Compugen. Today, we have an internally discovered Pipeline of about 30 candidates for targeted medicines in key areas of significant unmet medical need and high industry interest, about half of which are moving forward with priority validation and development.

In addition, during this time period, we have successfully integrated in-house expertise and development capabilities for both arms of our pipeline, while maintaining and enhancing our computational discovery leadership. However, as a pioneering company in an area with a history of failures by many others, in order to attain success as a public company, Compugen requires the positive recognition of three important audiences; he scientific communities, the pharmaceutical industry and the financial community and most certainly in that order.

With respect to the scientific community, this recognition begun to be achieved from our earliest years as our scientists made important breakthroughs in the predictive understandings of key biological phenomena at the molecular level such as alternative splicing, naturally occurring antisense, pseudogenes, so called junk DNA and others, often contradicting what was generally believed at the time. But although these scientific achievements were to prove fundamental in building our competitive advantage in predictive discovery, they had and for good reasons, only a minor impact in the industry and even less in the financial community.

The second required recognition, that of the pharmaceutical industry, has been more difficult. In view of so many past failures, both internally and externally with predictive biology approaches, it soon became apparent to us that the only path to recognition would be in the form of results, not promises nor great sounding science. Fortunately now with very attractive product candidates successfully moving forward in our pipeline, we are rapidly achieving the second required recognition. As we continue to have an increasing number of extensive interactions with major pharmaceutical companies in North America, Europe and Asia, which have more than doubled in number since our last quarterly call, we are receiving very positive feedback both with respect to our unique discovery capabilities and with respect to potential collaborations covering our leading product candidates.

This now leaves us with only the third and final required recognition for success as a public company, that of the financial community itself. It is important to note that in general, the financial community values modest sized or even sometimes large biopharma companies based on an evaluation of the potential and status of such companies’ one or two lead products. This methodology usually makes sense in view of the fact that success or failure for these companies most likely would be dependent on that product or products and if they fail as unfortunately so often they do, in many cases or almost – all or almost all shareholder value would be lost.

However, Compugen’s product oriented achievements starting the past three years in terms of both quantity and quality, are showing that this is not the case for us. As previously stated, the number of novel candidates discovered by us and their very positive in vitro and in vivo experimental results, exceeding even our own expectations, is more than impressive and that is so even without considering that these are the results from only our initial discovery efforts in our first fields of focus.

Now, as leading companies in the pharmaceutical industry begin to validate this assessment of our unique discovery capabilities and attractive product candidates, the financial community should obtain the required information it needs to properly value Compugen as a publicly owned company.

In today’s call, Dikla will next comment on our financial results for the quarter, which were as anticipated other than a lesser than expected net burn due to timing issues and then Anat will provide more insight into the basis for our confidence that the stage has now been set for the short term and continuing demonstration by Compugen of the exceptional medical and financial values that have been established over more than a decade by our superb, multi disciplinary scientific team. We will then open the calls for any questions that you might have. Dikla?

Dikla Czaczkes Axselbrad

Thank you, Martin. As Martin mentioned, our financial results for the quarter were in line with our expectation. However, there are a few items that deserve further explanation. The approximately $100,000 in revenue for both the third quarter of 2012 and the nine months ending September 30, 2012, represent a payment of certain research activities we performed for our joint venture with Merck-Serono that was announced in June this year.

The net loss of $8.3 million for the nine months of 2012 compared with $7.7 million for the first nine months of 2011 include $1.3 million in non-cash charges related to the complicated accounting required for the basic arrangements, compared to $800,000 in the first nine months of 2011 for this arrangement.

The reported increase of about $1.9 million in R&D expenses net for the first nine months of 2012 is largely due to establishment and initiation of activities at the South San Francisco facility as well as increasing level of activities in the company’s pipeline program. Higher pipeline cost involved independent investigated and service providers performing evaluation studies and an increased usage of lab material. Increased R&D expenses also reflect the impact of low governmental grants compared with 2011 given that such grants are deducted from research and development expenses.

This increased level of R&D activity and in particular the establishment and initiation of activities at the South San Francisco operation also explained the increased level of fixed assets at the end of the quarter.

With respect to our current cash status, we ended the third quarter of 2012 with approximately $20.1 million in cash and cash related account. This total of $20.1 million does not include $5 million due to be received later in 2012 under the second phase research and development funding arrangement, or the montage value of our Evogene shares. In addition, Compugen continues to have no long term debt other than the book liability associated with the research and development funding arrangement.

And with that, I will turn the call over to Anat.

Dr. Anat Cohen-Dayag

Thank you Dikla. As Martin mentioned, less than three years ago, Compugen selected protein therapeutics, namely Fc Fusion and monoclonal antibodies for oncology and immunology as our first areas of focus. In my prepared remarks today, I would like to provide you with an overview of our product related accomplishments since then in terms of both quantity and quality.

We are now receiving clear and positive feedback from major pharmaceutical companies in terms of appreciation of and interest in both our unique discovery capabilities and our leading product candidates. Since we have a high degree of confidence that this will result in the type of validation required by the financial community to properly value both our pipeline and our company, we believe it is important for us to communicate these achievements to our shareholders.

Primarily during the past two years, we have pursued validation of our product candidate in parallel with early stage development activities involving our prioritized list of candidates. This has included numerous experimental studies supporting the progress of the execution program and its respective antibody target program. These studies performed both in-house and by our network of collaborators, included this cord test to demonstrate that the novel molecules has the predicted activities and specifically for the Fc Fusion, multiple in vitro experiments using these animal models that the industry relies on to validate these product candidate.

Our average rate of success for all of these validation studies has been far in excess of 50% demonstrating conclusively the following accuracy of our predictive capabilities. For example, the fact that five out of the six Fc Fusion product candidates based on our novel B7-like prediction, have shown positive results in relevant autoimmune disease model has been referred to by several experts in the field and potential pharma partner as remarkable.

The therapeutic potential of our multiple product candidates have allowed us to establish a network of outstanding collaborators, key opinion leaders and expert consultants who are helping us to advance our pipeline through diverse guidance and or active implementation. You will be hearing more about these collaborations in the coming months.

Moving now more specifically to our pipeline, approximately half of our candidates consist of novel targets for antibody therapy in cancer, while another half consists of execution therapeutics for autoimmune diseases. A significant number of our pipeline candidates are based on our discovery of multiple B7/CD28 immune checkpoint proteins, which represent our first proper discovery effort using the integrated infrastructure established over the prior decade.

The B7/CD28-like immune checkpoint proteins are exciting discoveries as they represent a very promising approach to fight diseases like cancer and autoimmune diseases through the modulation of the immune system. Each immune checkpoint protein ahs the potential to serve as a target for antibody cancer therapy, whereas the extracellular domain which is the portion of the molecule that recognizes the immune system may form the basis of an execution protein for the treatment of autoimmune diseases.

Since the modulation of the immune system by immune checkpoints is perhaps the most exciting approach in cancer and autoimmune disease therapy, it is not surprising that significant efforts have been spent by others in discovery attempts. Consequently, our discovery of nine such markers is perceived as very impressive by the major pharmaceutical companies with whom we are in discussions as well as by key opinion leaders in this field.

With respect to Fc Fusion proteins, the better we understand the mechanisms of action of our candidates, the better we can use them to specifically target additional therapeutic indications as well as differentiate them from know therapeutic agents. Deeper understanding of the mechanisms perfection also allows the selection of the optimal indication for the clinical development of the drug candidate.

Our Fc Fusion proteins modulate immune response through a negative co-stimulatory effect specifically exerted through the modulation of T-cells which are major players in the protein adaptive immune response in autoimmune diseases. We recently have expanded our mode of action studies to include additional T-cell subtypes. In this respect, we recently reported that CGEN-15001 also promotes inducible regulatory T-cells or iTregs that are key anti inflammatory cells in addition to its previously reported inhibitory effect on inflammatory T-cells.

iTreg induction is considered an extremely promising approach for treatment of autoimmunity and also suggests a compelling mechanism of action as a cancer target for CGEN-15001T. the Compugen discovered B7/CD28 type protein on which the CGEN-15001 Fc Fusion protein is based.

With respect to antibody therapy for cancer, the value of an antibody drug is largely dependent on the attribute of the target that it recognizes and binds to. At Compugen, the discovery efforts for novel antibody targets takes place in Israel and during the past three years we have discovered a large number of very attractive novel targets.

As disclosed in our press release last Wednesday, recent results demonstrate that our dress targets may offer various modes of action and may impact multiple disease indications for cancer treatment. In addition to our previously disclosed results for other Compugen B7 (inaudible) iTreg target, the recent results we disclosed for two of our drug targets suggests that their mode of action affects both arms of the immune response, DNA and adaptive immune responses with specific modulation of key immune cells.

We are very pleased by the continued broadening of our early stage oncology pipeline and its potential to provide distinct and effective solutions for multiple types of cancer through utilization of therapeutic antibodies. This is particularly important in view of the understanding that combination of multiple modes of action will be required in the pursuit of effective cancer treatment.

Earlier this year, we established Compugen Inc. in South San Francisco for the development of monoclonal antibodies against Compugen discovered targets as therapeutic product candidates. As previously stated, the core value of an antibody therapeutic is directly tied to the attributes of the target. Validated antibodies against novel targets for oncology with characteristics of immune checkpoints such as those discovered by Compugen are considered to be among the most attractive product candidates in the industry and have been termed the next frontier in oncology.

At our South San Francisco subsidiary, we have quickly and efficiently formed a team that consists of scientists with extensive industry experience in the fields of therapeutic human antibody discovery and preclinical development. To date, this team has initiated antibody discovery programs for three drug targets, with several binding antibodies already identified for two of these targets.

Compugen Inc. is using two distinct pathways for the identification of antibodies against our target. The first involves in-house screening of a library of fully human antibodies using our target proteins and the second relies on the generation of mouse antibodies by a hybrid donor approach through outsourcing. Such a mouse antibody will later be immunized in expat for product development. Having access to the two different approaches increases our throughput capacity and allows the team to select the methodology most suited for each target in order to increase its probability of success.

We are focusing on two different types of antibody therapeutics to serve as the actual drug product. First are the so-called naked antibodies that are designed to block or enhance the action of a target. Such antibodies are appropriate for immune checkpoint regulatory proteins. They are expected to remove the proteins inhibitory effect on the immune cells and therefore enhance anti tumor immunity and increase the efficacy of cancer immunotherapy. This type of antibody therapy is of great interest to many leading pharma companies due to recent results observed with Bristol Myers Squibb antibodies.

These two BMS antibodies, each of which block a known immune checkpoint, have lately demonstrated impressive clinical benefit even for end stage patients, most notably unprecedented durable responses and long term survivors. The second type of antibodies we’re focusing on are antibody drug conjugates known as AVCs which have already shown strong clinical proof of concept by pharma companies. In this approach, the antibody is linked to a known high potency chemotherapeutic agent also called the payload.

In this case, the antibody specifically targets the cancer cell when the payload is released and it selectively kills the cancer cell. Specificity is primarily determined by high target expression on the tumor cells with little or no expression on normal tissue. Using our MEG database, we have been able to identify a number of proteins that meet those expression criteria and we are currently validating them as ADC targets and cancer.

Before closing, I want to say a few words about our continuing activities with respect to our unique and broadly applicable predictive discovery infrastructure. Since this is what has allowed us to establish our very impressive pipeline in less than three years and is the base on which future directions of the company will depend. Our major infrastructure activities at present relate to developing new discovery algorithms and mixing and matching existing algorithms to focus on the discovery of additional drug candidates.

In addition, we are incorporating to this unique discovery infrastructure of multiple discovery platforms, predictive algorithm and computation of biology to new capabilities such as the ability to include the analysis of next generation sequencing data which was announced in July.

And with that, we will begin the Q&A portion of this conference call. We will be grateful if each time you are recognized by the moderator you will limit your question to one plus a short follow up if necessary.

Question-and-Answer Session

Operator

Thank you. Ladies and gentlemen, at this time we will begin the question-and-answer session (operator instructions). Please stand by while we pool for your questions. The first question is from Mara Goldstein, of Cantor Fitzgerald. Please go ahead.

Mara Goldstein – Cantor Fitzgerald

Thanks very much. Can you hear me?

Martin Gerstel 

Yes.

Mara Goldstein – Cantor Fitzgerald

Great. Just briefly on the San Francisco operations. I am just wondering about the status of staffing there. Just thinking back to the last conference call and discussions of adding personnel there. And I am also interested in the checkpoint inhibitor program. And given this area is incredibly busy area and lots of interest in these programs on the part of the pharmaceuticals and clinical development. Well, I’m just wondering what your thoughts are in terms of how far to advance what you have before looking to monetize it for the partner.

Anat Cohen-Dayag

Okay. So it relates – first, to your first question about our San Francisco subsidiary. We’ve started discussing. We are almost done with it. Most of the staff is there already, started to work. Work was initiated full steam ahead and couple of drug charges that were already transferred from Israel to Inc and we are very happy with the first results that were seeing. As I stated we already have two programs that are showing some heat with antibodies from the three that we’ve initiated. With respect to checkpoint proteins, it’s a very good question. There is the real hype in this area as I stated in my remarks mainly due to the BMS results that were published in last our co-meeting in June and this gave such a boost to this field.

Of course there are a couple of companies that already have started the generation of antibodies to non-target, mainly working on PG1, PTL4 which are known immune checkpoints, which were discovered long ago. By the way we were using this an in-check point also in our discovery effort in order to find, tune our discovery parameters and to make sure that we are discovery stuff that is on one hand belong to this family but on the other hand maybe differentiated from this immune check points, and it is currently a field that is moving fast. We feel that we were able to come up with this discovery at the right point of time with respect to the fact that we are not now at a stage of just making the discoveries, we have made them some time ago.

We already have packages that are showing, starting to show the superiority of this molecules as compared to other molecules that are in the public domain that are not in development at all even and for molecules that are in development. By the way, not all the molecules could serve as therapeutic entities. They are molecules that are in the public domain and we feel that the packages that we have generated up till now, specifically for CGEN-15001 are of interest. We are very happy with the results that we are getting with the differentiation and superiority profiles that we could generate and while moving forward, full steam ahead in terms of R&D plans, we are in discussions with the Pharma companies around leading candidate but definitely this is a good time for us to be with this programs all the time.

Martin Gerstel 

Just to add from – it really is an excellent question because we must in answering that question internally; we have to take a number of factor into consideration. For example, we know that the for whatever reason the shareholders are waiting for quote ‘the first collaboration to be announced’. And so we have to take that into consideration and we are fortunate in that we have a number of molecules, it’s not just the typical one or two and this – so we have really a wealth of product candidates. But behind your question is the well-recognized understanding that as the further you take a product in development before you license it out you can see some very substantial increases in the returns that you get. So there clearly has to be a balance amongst these different factors and we’ll deal with that and we are dealing with that as we are continue these negotiations with the various companies that we are talking with.

Mara Goldstein – Cantor Fitzgerald

Okay. Thank you. I really appreciate the color.

Operator

The next question is from Brett Reiss, of Janney Montgomery Scott. Please go ahead.

Brett Reiss – Janney Montgomery Scott

Hi. Can you hear me?

Martin Gerstel 

Yes, we can.

Brett Reiss – Janney Montgomery Scott

Great. What’s the aggregate amount of large Pharma companies you are having these discussions on and is there any first mover advantage by any particular Pharma company to strike the first material deal with you?

Martin Gerstel 

We’ll, I think as we said we are talking with a number of companies and the fact that we stated that these are companies from North America, Europe and Asia I think will give you a feeling that there are a number of companies there. If it’s a reasonable number it would be misleading to actually state the number because that is the question as to where do you draw the line and then if you want the number of companies that we’ve discussed our products with, it’s a very big number, if you want the number that where the current discussions are at a certain stage, then of course it gets -- some of these companies are at earlier stages. And from the stand point of sort of a first mover advantage, I don’t think that – we are talking with major companies and this is an area of high, a very high interest for them but they look at this and then obviously in a very professional and careful way. You can imagine the number of product opportunities they see both internally and externally and – so at this stage, they are just going through their due diligence. Anat, you want to add more?

Anat Cohen-Dayag

I think that with respect to your last comment about priority I would like to add that we are not conducting the discussions based on priority. This is more has to do with how much there is the fit, there’s an expertise that is associated with this type of per candidate and to make sure that we increase the probability of success of our molecules in the clinic. Either in clinical trials or later and all these parameters has to do with setting priorities. And also one other thing that we take into consideration is how much the partner will have an interest for us to participate in early stages of development and increase probability of success.

Brett Reiss – Janney Montgomery Scott

Can I ask another one or you want me to get back in queue?

Martin Gerstel 

That’s okay. One more you got.

Brett Reiss – Janney Montgomery Scott

Okay. This operative phase in your press release clear and positive feedback we are receiving from major pharmaceutical companies. Pretend I am your six year old grandson. Can you describe to your six year grandson what – can you be a little descriptive what are those conversations revolve around? What are they asking you? What are you saying to them?

Anat Cohen-Dayag

I think that it will be a mistake for us to dive into the details of discussions that we are having but of course we are relating to their impression with respect to our discovery capabilities that have led to these discoveries of product candidates and to the potential value of the product candidates themselves but I think that we can’t get into the details of discussion.

Martin Gerstel 

One aspect of this that I have found interesting is that in earlier discussions with pharmaceutical companies before we had the pipeline and we are attempting to get them to work with us with respect to our capabilities. The questions always related to them trying to understand our – the way we did things, how do we do the predictive discovery. Even to the extent of some of them even wanting to have access to the certain of the algorithms that we utilize, which of course we would not share with them. What is totally different now is when they see these results, the question as to how do we do things goes out the window. The results speak for themselves, there’s absolutely no reason now for any pharmaceutical company to have to make a judgment as to whether or not our predictive biology works. The evidence is 100% clear, we’ve used -- in areas of high interest for them in a tiny fraction of the time and money that has been committed to this field by others.

Orders of magnitude less by us than other people, we have made discoveries that they have not been able to make and not only that but have now taken those discoveries into the exact same disease animal models that they rely on in order to evaluate whether or not their product candidates are worthy of further development and are not referred to the incredible level of success we have had in these meetings. So I would say following up on whether or not that one, there is an enormous appreciation for the uniqueness and the accuracy and the power of what we’ve accomplished here in the case the infrastructure that now exists here and there is a very strong interest, and it varies company by company, indication by indication, molecule by molecule. So it’s in many different areas but there’s a significant amount of interest out there.

Brett Reiss – Janney Montgomery Scott

Has any company…

Martin Gerstel 

We’ll, that’s your third.

Brett Reiss – Janney Montgomery Scott

Okay. I’ll drop back.

Operator

(Operator instructions). Please stand by while we pool for more questions. The next question is from Klaus Von Stutterheim – Deutsche Bank. Please go ahead.

Klaus Von Stutterheim – Deutsche Bank

Can you talk about the expected burn rate for the next 12 to 24 months and possible sources of funding?

Martin Gerstel 

Well, as Dikla mentioned, we had capital available, available sources of capital that takes us we’ll into 2014 given our current burn rate. And our burn rate is very much under our control in view of the fact that if we were to increase it would be with doing more tests out of – not in the company but with providers and whatever. So we don’t see any immediate crisis in any way. Of course companies like ours should always have substantial cash on board.

Dikla Czaczkes Axselbrad

I would add to that as you probably can imagine we are now in the process of budgeting for 2013 and this will of course be approved. The budget will of course be presented with the board and approved by them hopefully. And we’ll probably give specific guidelines at the end of the year but as of now we do not see dramatic change from this year level of expenses.

Klaus Von Stutterheim – Deutsche Bank

Many thanks.

Operator

The next question is a follow up question from Brett Reiss, from Janney Montgomery Scott. Please go ahead.

Brett Reiss – Janney Montgomery Scott

Hello again. Had the discussions with any particular Pharma company gotten to the point where they have specifically said to you what more they need from you before they would be willing to commit to material financial deal where there’s material consideration that would be extended to the company?

Martin Gerstel 

I don’t think we should get into this discussion but the only thing I would say is that the discussions really don’t kind of don’t go there in that direction. They do their due diligence, they request information, we provide it to them. So but I guess let me just drop it at that. We cannot – even if we wanted to, there’s not very little that we could tell you that would assist you to give you what you are looking for that is because we can’t. No one can really know when the first deal is going to be signed. There’s just no way – these are complicated agreements and the complications get involve in its intellectual property and licensing rights and all kinds of due diligence requirements, things that -- they are very complicated agreements. So they can take some fairly extensive time just to draft the arrangements.

Brett Reiss – Janney Montgomery Scott

Okay. Thank you.

Operator

There are no further questions at this time. Before I ask Dr. Cohen-Dayag to go ahead into our closing statements, I would like to remind participants that a replay of this call is scheduled to begin in two hours for a period of 72 hours. In the U.S. please call 188-782-4291. In Israel, please call 03-925-5904. Internationally please call 972-3-925-5904. Dr. Cohen-Dayag, please go ahead with your concluding statement.

Anat Cohen-Dayag

Yes, thank you. Before assuming the CEO position at Compugen in early 2010, I had been head of our R&D activities and therefore had a good appreciation of the capabilities and enormous potential that had been created by our exceptional team of scientists. However, the proof of this potential at that time was largely in the form of novel molecules demonstrative the discovery capabilities of the individual platforms but not necessarily molecules targeting clear un-mathematical needs with superior properties to those already known. These discoveries were critical in validating the predictive capabilities but not very useful when trying to convince others that Compugen’s discovery infrastructure could be focused to specific areas of interest and lead to popular candidates with potential superiority.

Therefore, my first major decision as the CEO was to undertake our initial market directed discovery program utilizing all of our integrated capabilities not just in individual discovery platform in an area of high industry interest and direct them towards the discovery of superior targeted medicine. As we have discussed, we chose the very complex fields of Oncology and Immunology, and within these fields our first area was the B7/CD28 immune check point family of proteins. Since this protein family is of immense interest in the industry with applications in both of our fields of focus. Furthermore, new family members had proven extremely difficult to find using conventional experimental basic discovery effort. We are very pleased to be now sharing the exceptional results we have achieved in this first proper discovery efforts with leading companies in our industry.

The response we are receiving is very satisfying not just with respect to the medical and commercial potential of our product candidate but with respect to validation of the power and uniqueness of the predictive discovery infrastructure that we have created and continued to enhance. With this in mind as we now approach the commercialization stage in the form of collaboration agreement for the first wave for our product candidate from our pipe end program, we want to particularly thank our long term shareholders who have supported us through this long but value creating journey. Thank you and we look forward to sharing with you further development in the near future.

Operator

Thank you. This concludes the Compugen Limited third quarter 2012 financial results conference call. Thank you for your participation. You may go ahead and disconnect.

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