Christine Klaskin - VP of Finance Garo Armen - Chairman and CEO Robert Stein - CSO.

John Sonnier - William Blair Jason Kolbert - Maxim Group George Zavoico - MLV Ren Benjamin - H.C. Wainwright Mike King - JMP Securities.

Good day, ladies and gentlemen. And welcome to the Agenus Q3 Earnings Conference Call. As a reminder, today's conference is being recorded. At this time, I would like to turn the conference over to Christine Klaskin, Vice President of Finance. Please go ahead. Ms. Klaskin..

Thank you. Welcome to the Agenus conference call to discuss our third quarter 2014 financial results. With me today are Dr. Garo Armen, Chairman and Chief Executive Officer and Dr. Robert Stein, Chief Scientific Officer. During this call, we will review our financial results, as well as provide a corporate update.

We will then open up the call for questions-and-answers.

Before I continue, I would like to remind you that this conference call will contain forward-looking statements, including statements regarding the Company's potential income stream, research and development and clinical trial activity, the publication of data and potential application of the Company’s technologies and product candidates and the prevention and treatment of diseases.

These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. Reference to these risks and uncertainties is made in today's press release and they are disclosed in more detail in our most recent filings with the U.S. Securities and Exchange Commission.

These statements speak only as of the date of this call and Agenus undertakes no obligation to update or revise these statements. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

When evaluating Agenus' business and securities, investors should give careful consideration to these risks and uncertainties. As a remainder, this call is being recorded for audio broadcast. With that, I will now review our third quarter 2014 financial results.

The Company's net loss attributable to common stockholders for the third quarter of 2014 was $8.2 million or $0.13 per share basic and diluted compared to a net loss attributable to common stockholders of 7.4 million or $0.24 per share basic and diluted for the third quarter of 2013.

For the nine months ended September 30, 2014, the Company reported a net loss attributable to common stockholders of $16.7 million or $0.28 per share basic and diluted compared with a net loss attributable to common stockholders of $27.4 million or $0.99 per share basic and diluted for the nine months ended September 30, 2013.

The net loss for the nine months ended September 30, 2014 and the same period of 2013 was impacted by various corporate transactions. During these nine months of 2014, the Company recorded other non-cash income of $10.8 million related primarily to the impact of the termination of GSK's Phase III MAGE-A3 trial in non-small lung cancer.

As previously reported, during the first quarter of 2014, the Company acquired all of the outstanding stock of 4-Antibody AG, also contributing to the variance in the year-over-year net loss during the same period of 2013, the Company's preferred stock restructuring which reduced the dividend requirements for its Series A1 preferred securities resulted in a non-cash deemed dividend of $2.9 million and the retirement of its then outstanding $39 million, 8% senior secured convertible notes due August 2014 resulted in a non-cash expense of $3.3 million.

Cash, cash equivalents and short-term investments were $52.9 million as of September 30, 2014. Based on our current operating plan and without any funding from potential corporate transactions, we believe we have sufficient financial resources to fund our operations through mid-2015. This concludes the financial portion of the call. Dr.

Armen will now provide a corporate update..

Thank you, Christine. During the third quarter, Agenus continued to make solid progress in advancing its product pipeline. As you may recall during the second quarter, we signed our first pharma collaboration in the checkpoint modulator field with Merck, a leader in this field.

During the third quarter, we have made good progress towards our collaborative goal of discovering checkpoint modulating antibodies against the two undisclosed Merck checkpoint targets which by the way are separate from our own fixed checkpoint modulator programs.

As we previously noted, successful execution of this collaboration could provide to Agenus approximately 100 million in milestone payments, as well as royalties on worldwide product sales.

As announced in the second quarter, we reported very encouraging final results from a single-arm, open-label Phase II trial for our cancer vaccine Prophage in newly diagnosed glioblastoma multiforme, a highly aggressive form of brain cancer which represents the most common primary form of adult brain cancers, for which as you know, there is currently no effective treatment.

The results showed a substantial improvement both in progression free survival and median overall survival for Prophage combined with standard of care. At this time, we continue to explore strategic and financing options for further advancement of Prophage as a treatment for this important unmet medical need.

During the third quarter, we also continued to advance our portfolio of novel checkpoint modulator immuno-oncology programs towards our first anticipated IND filing next year. As you know, checkpoint modulators have generated remarkable results in the treatment of several kinds of cancers including melanoma.

And they're now widely viewed as being a critical foundation of evolving treatment paradigm in oncology.

Agenus is uniquely positioned in the immuno-oncology field in having three sets of important and potentially combinable assets our portfolio of checkpoint modulators, our heat shock protein-based vaccines and our proprietary QS-21 Stimulon adjuvant.

During the third quarter, we also announced that our partner GlaxoSmithKline filed the world's first regulatory application in the EU for a malaria vaccine that is the world's first malaria vaccine.

Based on its successful Phase III program which involved 16,000 patients, GSK vaccine utilizes our proprietary QS-21 Stimulon adjuvant which functions to boost immune response achievable with the GSK vaccine. This vaccine addresses an urgent medical need as about 600,000 children die each year in Africa from malaria.

Up until now, there has been no effective vaccine. This regulatory submission triggered a milestone payment for us and Agenus is also entitled to receive an additional milestone payment upon regulatory approval, as well as, as you know royalties from future product sales.

QS-21 Stimulon is being currently evaluated in a number of vaccine programs by our partners, including several in Phase II and Phase III clinical trials. With that, I'm pleased to turn the call over to Dr. Robert Stein our Chief Scientific Officer for additional comments.

Bob?.

Thank you, Garo. As Garo mentioned, during this quarter we made solid progress on a variety of research programs.

With respect to our collaboration with Merck, we're making very good advances in our efforts to discover fully human antibodies that modulate the two novel checkpoint targets validated by Merck scientists as points of intervention to increase anti-tumor immune activity.

Merck will be responsible for clinical development and commercialization of any product candidates generated under our collaboration. As Garo also noted, successful execution of this collaboration could provide to Agenus about $100 million in milestone payments, as well as royalties on future product sales.

As Garo also noted, during the second quarter, we reported encouraging results from a single-arm Phase II study of our cancer vaccine Prophage in patients with glioblastoma multiforme or GBM.

Prophage is an autologous cancer vaccine prepared from each patient's own surgically resected tumor and therefore it is a highly individualized patient-specific form of treatment. As previously stated, we've completed an end of Phase II meeting with the FDA and it is our goal to advance Prophage into a registration study with a corporate partner.

Agenus is uniquely positioned in the oncology space and having an immune education or targeting approach such as our Prophage heat shock protein-based vaccine, together with a broad portfolio of 6 checkpoint modulator antibody programs aimed at blocking PD-1, CTLA-4, TIM-3 or LAG-3 or activating GITR or OX40.

Checkpoint modulators function as the thermostat of the immune system acting to stimulate rapid generation of immunity to infectious organisms, but also to then down regulate immune response in order to limit the possible damage to otherwise normal tissues.

In the last five years it has become apparent that cancers often hijack the checkpoint systems to evade destruction by the immune system.

The exciting recent advances in the treatment and even cures of advanced cancers have resulted from the realization that antibodies that modulate checkpoint processes, that is checkpoint modulators or CPMs can restore immune balance and then lead to immune destruction of cancerous tissue and to long-term survival in patients with advanced cancers that would previously have been untreatable.

The advances in the use of CPMs to treat cancer have in several cases been truly spectacular, such as in the treatment of melanomas with therapies like CTLA-4 and PD-1 blockers have effectively achieved cures in very large percentages of patients.

The recent rapid FDA approval of Merck's PD-1 blocker KEYTRUDA speaks to the dramatic benefits of such therapies and the need to expedite their delivery to patients with unmet medical needs. Combining checkpoint modulators has produced even more compelling efficacy but this can also bring more severe and frequent immune-mediated side effects.

Thus, a key challenge in the use of CPM combinations is how to achieve increased immune activation towards the tumor for fewer unwanted immune-mediated side effects.

The combination of Agenus’s immune educating vaccines like Prophage, together with CPMs could improve outcomes by safely directing the patient’s immune system specifically to the tumor with fewer immune-mediated side effects.

In addition Agenus’s portfolio of CPMs allows us to test combinations of agonist antibodies to receptors like GITR or OX40 which we tend to applying to gas paddle of the car togetherly with antagonist antibodies to receptors like CTLA-4, PD-1 which would be analogous to releasing the brakes of the car.

At Agenus, we’re continuously strengthening our world-class translational biology research efforts in order to ensure that we can rationally and expeditiously test various combinations with checkpoint modular with each other and with our cancer vaccines.

During the third quarter, we made solid progress towards advancing our pre-clinical staged CMP programs towards our first anticipated IND filings in 2015. We’re also continuing to leverage our proprietary Retrocyte Display platform to generate more monoclonal antibodies against new checkpoint targets. Thank you for your attention.

At this point I’d like to turn the discussion back over to Garo..

Thank you very much, Bob. We at Agenus look forward to providing our shareholders with further updates on our continued progress on the advancement of our checkpoint programs, as well as our collaborations with GSK and Merck.

We remain committed to developing the next-generation of immunotherapies that will further advance the ongoing paradigm shifts in the treatment of cancer. We hope that you found this update helpful. And with that I will once again turn the call back to Christine..

Thank you, Garo. Operator, you can now open the call for questions-and-answers..

.

.

Thank you. (Operator Instructions) We’ll now take our first question from John Sonnier at William Blair. Please go ahead..

Garo just even listening to this earnings cycle, it seems everyone Celgene, Seattle Genetics everyone is pursuing combinations in one form or another. And it really does seem like we’re starting up 2015 maybe even as soon as ASCO. To be more a discussion of combinations and what has historically been a combination about PD-1 inhibitors.

And so it brings into question, I guess how Agenus fits into this bigger picture, combinations I think are going to be incredibly relevant in the future. But at what point do you think the larger corporate collaborators will want to seek your clinical assets.

Is it as simple as Phase I data or do you want to move your products further along? And then any thinking on how you might partner in a non-exclusive manner would also be helpful. Thanks..

Garo just even listening to this earnings cycle, it seems everyone Celgene, Seattle Genetics everyone is pursuing combinations in one form or another. And it really does seem like we’re starting up 2015 maybe even as soon as ASCO. To be more a discussion of combinations and what has historically been a combination about PD-1 inhibitors.

And so it brings into question, I guess how Agenus fits into this bigger picture, combinations I think are going to be incredibly relevant in the future. But at what point do you think the larger corporate collaborators will want to seek your clinical assets.

Is it as simple as Phase I data or do you want to move your products further along? And then any thinking on how you might partner in a non-exclusive manner would also be helpful. Thanks..

John you have asked a very comprehensive and very complicated question, I’ll make an attempt to addressing some of it and then I’ll ask Bob to see to explore his thoughts. Suffice it to say and you mentioned that combinations are going to be the wave of the future and we as a company as a team here believe that is absolutely the case.

We think combinations will drive the future of immuno-oncology and perhaps even other diseases. Now if you move in that direction clearly one of the things that you would like to evaluate is you have the full portfolio of things to combine in any way that you should.

And the answer to that question is absolutely yes, we have a very comprehensive portfolio of checkpoint targets that we’re pursuing. In addition to that, we also have a very-very powerful technology platform that could generate many more targets at will pretty much.

That’s one of the reasons for example Merck came to us and explored the idea of using our technology platform to develop molecules to their own proprietary target.

So we have the checkpoint area pretty comprehensively covered, but very importantly beyond that we also have the vaccine side the ability to stimulate the immune system in addition to the other helpers that we have in our portfolio in the form of checkpoint molecules, as well as adjuvant and that’s going to be an increasingly important piece and Bob could comment on that, but in terms of your question of how do we balance things and time things.

At any given point, we evaluate obviously what is best for us? What type of a collaboration? And what type of a financing option? And we’re actively looking at a number of options right now. And so I don’t want to make any comments other than say that we’re exploring a number of collaborative, as well as financing options.

And we will let our investors know obviously appropriately as these conversations mature to a point of announcement. But suffice it to say, it has been in an extremely active area and we've had our hands full in pursuing a number of these options and activities. Bob, would you like to comment any additional….

Thank you, Garo. Hi, John, I think it’s a very good question. It's clear that combinations will be very important. It's also clear that not one combination will address every need having the flexibility of combining our various programs as the patient’s needs dictate is going to be very important.

And it’s hard to control that if they are not under your own roof. So there will be co-operative attempts with other companies but it becomes much more feasible if you actually have the assets yourself.

And then of course during the eventual commercialization, it’s much more powerful to be able to combine the various products as the needs of the patients dictate. We also as Garo pointed out, have the immuno-education heritage and Prophage approach to generating T-cell responses to tumor specific neo-antigens.

Now it’s turning out to be extremely important.

The tumors were the best results you are seeing just by removing the breaks on the immune system by blocking things like CTLA-4 and PD-1 are the tumors that are very high in mutational burden compared to most cancers and that's because they result from carcinogen exposure like UV light in the case of melanoma or benzo-pyrones et cetera in the case of lung cancer.

And in these tumors that have less difference between cell and non-cell, are between the cells and the cancer, you may need to encourage more recognition of the tumor by the immune system. And so the deactivating checkpoint modulators like GITR agonist or OX40 agonist maybe more important we have those.

And then actually targeting the immune response to the tumor and away from normal tissues that otherwise suffer collateral damage is also important. So the immuno-education piece that we can provide through Prophage or related strategies can become very important for a large number of types of tumors.

So there is a lot of interest from pharma companies in what we have but we want to be very thoughtful about how to partner so that we actually can take advantage of the power of being able to combine these things in intelligent ways..

We will now take our next question from Jason Kolbert at Maxim. Please go ahead..

Hi, guys, a couple of accounting questions. You talked about on the second quarter, a $3 million payment that might be booked in this quarter and that didn't seem to show off.

Did I not understand that properly from the prior quarter?.

Hi, guys, a couple of accounting questions. You talked about on the second quarter, a $3 million payment that might be booked in this quarter and that didn't seem to show off.

Did I not understand that properly from the prior quarter?.

So Jason I don't know what you are referring to, but you said it's a $3 million payment for what, again?.

I believe that was a legacy payment from GSK that was going to be booked in the quarter..

I believe that was a legacy payment from GSK that was going to be booked in the quarter..

Right, so we did receive with a -- it was $2 million milestone payment from GSK..

Okay.

But that didn't show up in the reported financials or?.

Okay.

But that didn't show up in the reported financials or?.

That was recorded as revenue in Q2..

Okay. I don't know why I thought that was Q3. Sorry -- thanks..

Okay. I don't know why I thought that was Q3. Sorry -- thanks..

That's okay. The cash was received in Q3, but the milestone was achieved in revenue recorded in Q2..

Got it, and so it was booked as such. Okay, I guess I didn't understand that. Thank you. And you also talked about the runway Garo going through mid-2015, but our calculations would put you well beyond 2015.

So I mean if you finished with $50 million on the balance sheet, shouldn't that take you out through the end of next year?.

Got it, and so it was booked as such. Okay, I guess I didn't understand that. Thank you. And you also talked about the runway Garo going through mid-2015, but our calculations would put you well beyond 2015.

So I mean if you finished with $50 million on the balance sheet, shouldn't that take you out through the end of next year?.

A couple of comments on that, so we will finish the year with slightly less than the number you are projecting, however, our estimate for the runway through the middle of next year is a very-very conservative number based on a substantially extended activity which if, we were not doing this with a collaborator would probably be trimmed down some.

So it’s a very conservative number that we released just to be certain that we have covered all basis..

Good. And I thought so I just wanted to hear you say that.

So now can you talk about the really interesting and exciting stuff which is a couple of things, how active is BD in terms of a partnership to move GBM forward? And maybe the most important question kind of taking off the prior analyst question is, when you look at checkpoints and you look at combinations, you mentioned melanoma, there are other companies that are working on melanoma with therapeutics like up-regulation of IL-12 that just makes sense in combination.

So what kind of areas do you think are the most attractive and should we expect to seek some type of collaboration in 2015?.

Good. And I thought so I just wanted to hear you say that.

So now can you talk about the really interesting and exciting stuff which is a couple of things, how active is BD in terms of a partnership to move GBM forward? And maybe the most important question kind of taking off the prior analyst question is, when you look at checkpoints and you look at combinations, you mentioned melanoma, there are other companies that are working on melanoma with therapeutics like up-regulation of IL-12 that just makes sense in combination.

So what kind of areas do you think are the most attractive and should we expect to seek some type of collaboration in 2015?.

So let me answer your question broadly and maybe Bob will want to comment on the types of combinations, but we don't want to reveal any proprietary information, because in spite of the fact that there are giants playing in this field, we feel Jason very-very confident that we have substantial in-house knowhow and expertise in the field and that is building by the day almost now.

So, in terms of your first question how active we are? Our two top priorities as a company right now, are certainly to move our internal programs to the next level of value creation and that is defined in our book now as a process which will allow us to start clinical trials and that we anticipate will happen perhaps as early as next year.

So, that is a very critical driver for us internally and it is a very important priority for the company. In addition to that, clearly engaging with the right partnership -- corporate partnership is also a very hard priority, I don't want to elaborate anymore than that but clearly we're not sitting back and relaxing.

We're very active in both the internal development programs and also seeking and I stress the right partnership with the right terms.

And Bob if you'd like to give us some general comments about, how do we go with regard to the subject of exploring the right combinations and perhaps be competitive in our ability to do that?.

Okay..

And the right cancer indications, right the cancer indications that represent the right combination of clinical pathway to market, time duration endpoints and revenue?.

And the right cancer indications, right the cancer indications that represent the right combination of clinical pathway to market, time duration endpoints and revenue?.

I think that those are all very good questions. One of the things that's going to be very important in this area Jason is to have excellent translational biology and immuno-monitoring capabilities.

So being able to characterize patients at the time they present from the degree to which the immune system has already recognized the tumor is non-self, the degree to which local forces maybe suppressing immune recognition and the nature of those forces or processes the degree to which checkpoint processes may have kicked in that blunt the effector function because those will allow you to decide what interventions make the most sense in individual patients.

It's unlikely that it's going to be entirely by type of tumor because even within a tumor like, type like melanoma the range of mutational burden can be quite high, it can range anywhere from say 500 base pairs for megabyte a DNA down to 1 to 10 depending on the individual patient.

And so there is a lot of interest right now not only from us because it's our heritage but also the across field in trying to understand the mutational burden and how that relates to the responses to the simple regimens of CTLA-4 blockade plus PD-1 blockade about 20% of melanoma patients don't respond and there is a lot of interest in knowing whether those patients with the lower mutational burden at the outset for instance.

So, we'll be engaged heavily in understanding the mutanome and the androgenic properties of tumors. We obviously will be part of the effort to understand which processes have kicked in.

There are a number of tumors whether there is a fairly high mutational burden but the responses are just releasing, the breaks hasn't been that good those include colorectal and prostate cancer where some additional boost on the checkpoint side with things like a GITR agonist or an OX40 agonist they turn out to be important or it may turn out that the recognition is blunted so that the immuno-education piece will become more important.

So, we're thoroughly engaged in understanding that as well it can be understood and applying the knowledge to design better approaches to combinations, where the idea would be not to have to wait till the traditional end-points of survival to understand whether we’re on the right track or not but to use intensive translational monitoring to detect signals for either being on the right path or being on the wrong path earlier and it points where less time and money has been expended and better decisions could be made..

We will now take our next question from the line of George Zavoico at MLV and Company. Please go ahead..

Checkpoints inhibitors you guys seem to be very focused as most are on the immuno-oncology space, but checkpoints are also quite active on the other side in auto immune diseases.

Are you at all exploring any avenues of opportunity in developing these same checkpoint inhibitors or agonists in auto immune indications?.

Checkpoints inhibitors you guys seem to be very focused as most are on the immuno-oncology space, but checkpoints are also quite active on the other side in auto immune diseases.

Are you at all exploring any avenues of opportunity in developing these same checkpoint inhibitors or agonists in auto immune indications?.

You're very-very strict George and I can't think of anybody better than Dr. Stein to answer that question..

There is so many who's here at the moment. Thank you George, yes you're of course on-track for every situation in which you want to use one of these checkpoint modulator interventions to boost immunity in cancer are perhaps in an infectious disease.

So flip side from oncology could be used to dampen down immune responses in the setting of either auto immunity or transplants, it’s very clear that a lot of the abnormal processes and things underlying rheumatoid arthritis or Crohn's disease or psoriasis or Lupus or MS may involve inappropriate activation of T-cells against self antigens where the thermostat has gone awry and we can find the compounds with the flip side pharmacology for instance GITR antagonist or OX40 antagonists that might have utility in the treatment of those diseases.

And we’re very aware that you are interested in exploring that and it’s a easily leverageable aspect of what we’re doing in the cancer space, because we have all the assays up in place, we’re generating the antibodies.

And what we’re doing is characterizing them to make sure that we understand which pharmacologic properties they have and which diseases they will be most effective in treating..

I am thinking about that because there aren’t too many companies currently involved in that and in my mind it’s pretty much of a wide open space, so..

I am thinking about that because there aren’t too many companies currently involved in that and in my mind it’s pretty much of a wide open space, so..

We agree with you completely, the initial wave of enthusiasm has been around the immuno-oncology opportunities because frankly as a physician the results are so spectacular and if you think about the benefit to patients it’s almost mind boggling and incredibly encouraging.

Very serious auto-immune diseases and also transplant remain very large unmet medical needs and all of the better and better treatments, none of them is free of side effect and none of them works in every case.

And to be able to fine tune the control system to the key in B-cell activities of the immune system could be very helpful and we’re certainly exploring that, partnering and interested in that as well..

Final question, I am actually very intrigued by your approach of combining a Prophage like vaccine for various cancers cells and GBM with the various checkpoint inhibitors, and again the number of pre-mutations possible between indications and checkpoint is quite remarkable.

So, there is going to be a lot of work that needs to be done to be able to prioritize which ones might be the most important.

In that regard for the Prophage type vaccine, are you working currently working on any other cancer with a Prophage like vaccine? And related to that what might the regulatory burden be? Would you have to show the vaccine effective and checkpoint effective before you can combine them in a clinical trial?.

Final question, I am actually very intrigued by your approach of combining a Prophage like vaccine for various cancers cells and GBM with the various checkpoint inhibitors, and again the number of pre-mutations possible between indications and checkpoint is quite remarkable.

So, there is going to be a lot of work that needs to be done to be able to prioritize which ones might be the most important.

In that regard for the Prophage type vaccine, are you working currently working on any other cancer with a Prophage like vaccine? And related to that what might the regulatory burden be? Would you have to show the vaccine effective and checkpoint effective before you can combine them in a clinical trial?.

That’s a very good question George.

Basically the Prophage vaccine takes advantage of the fact that we take a piece of the tumor of an individual which contains whatever mutant proteins that tumor happens to harbor and we prepare it in a way that allows it to as a cell free vaccine very effectively trigger T-cell responses against the abnormal proteins harbored by the tumor.

So it’s really not specific for GBM, it can be applied to any tumor for which you can harvest tissue, which means that many of the types of tumors that aren’t seeming to response are just releasing the break CPMs are fair game.

The Company has done large studies in the past in melanoma and immuno cell carcinoma with very good evidence that the vaccine provides benefit in some patients it just hasn’t been consistent enough across the board to get the product registered broadly for intense treat type studies.

We think that one of the key missing pieces maybe the absence of pervious combinations with checkpoint modulators. So in the future I don’t think that there is going to be a requirement you show single-agent efficacy, because if you look at some of these checkpoint modulators like TIM-3 or LAG-3.

There is good evidence they don’t do much by themselves but if you out them on top of PD-1 blockade you get a very good bump up in activity. And I think it’s recognized that these components may have a number of components which are necessary whereas none of them may be sufficient to produce robust activities on their own.

I think it’s going to drive a different paradigm for thinking about combination..

So the only burden, experimental burden or clinical trial burden for you to show them that they are safe as a monotherapy to break it to combine them?.

So the only burden, experimental burden or clinical trial burden for you to show them that they are safe as a monotherapy to break it to combine them?.

Yes, you probably have to do enough monotherapy work to demonstrate reasonable safety and you probably have to have some type of reasonable argument that combination is not going to unlock frightening combined toxicities..

Yes I agree, you will probably be going very careful in terms of dose escalation in those kinds of studies going forward, yes, yes..

Yes I agree, you will probably be going very careful in terms of dose escalation in those kinds of studies going forward, yes, yes..

What I guess is that you probably, the combination cycle haven’t started relevantly reduced doses of bone and work out..

Our next question comes from the line of Ren Benjamin at H. Wainwright. Please go ahead..

I know in the prepared remarks you mentioned that there is a lot of progress being made with the two programs with the undisclosed targets under Merck. As then a lot of progress is being made with the six programs the internally generated six programs antigen.

And I was hoping that we could get a little bit more color in terms of either what that progress might be of where the progress is right now. For example I think with several of the internal programs, I think in the past you had mentioned that you’re in lead identification mode.

And if we can, if we can dissect these programs and just kind of give us a sense as to where we are that would be great?.

I know in the prepared remarks you mentioned that there is a lot of progress being made with the two programs with the undisclosed targets under Merck. As then a lot of progress is being made with the six programs the internally generated six programs antigen.

And I was hoping that we could get a little bit more color in terms of either what that progress might be of where the progress is right now. For example I think with several of the internal programs, I think in the past you had mentioned that you’re in lead identification mode.

And if we can, if we can dissect these programs and just kind of give us a sense as to where we are that would be great?.

One overwriting comment is that as you know with our Merck collaboration we are not at liberty to disclose very much because there is lot of proprietary component to that collaboration.

We broadly stated that we've made progress and we are very pleased and clearly they are pleased with the progress we have made, but we cannot give you empirical sense of what we are talking about specifically.

Now with our internal programs we are a little bit more at liberty although we don't want to say too much about that for competitive reasons as well. But at this time we will give you some cover..

So Ren, Hello. Basically we are making the progress which we need to, to deliver on our objective which is to have compounds from all six of the programs in the clinic two years from now.

And we are on target for having our IND filings on first several of the programs by the end of 2015, so that's our stated objective, we are tracking to that objective because of such an intensely competitive area I actually don't want to say too much more than that.

We've publically stated that we have GITR agonists and they are I think very high quality compounds, they have many characteristics that are similar to what Merck is advancing but they have some properties which we think might actually be differentiating advantages and those are on target for IND filing by the end of 2015 and although there is of the GITR Inc.

and now the Merck compound in front of us we believe we might have the second serious entry into the field for eventual clinical benefit..

And when we are thinking about serious entries, is that, should we be thinking about it from a point of view of maybe improved efficacy, improved side effect profile, combination of both or is there something outside of those two that maybe we should think about?.

And when we are thinking about serious entries, is that, should we be thinking about it from a point of view of maybe improved efficacy, improved side effect profile, combination of both or is there something outside of those two that maybe we should think about?.

Well I think that it's probably premature to speculate on that. We have differentiated pharmacology that I think has the potential to read on efficacy..

Okay. Just I know that in the past you had mentioned which were the lead programs and I think just right now you mentioned that the GITR program could have an IND filed by the end of 2015.

Would you be able to just give us a sense because I don't know if some things are fallen back or some things have taken priority, kind of what the leads are and what might be the first INDs that are filed versus the second, third and fourth?.

Okay. Just I know that in the past you had mentioned which were the lead programs and I think just right now you mentioned that the GITR program could have an IND filed by the end of 2015.

Would you be able to just give us a sense because I don't know if some things are fallen back or some things have taken priority, kind of what the leads are and what might be the first INDs that are filed versus the second, third and fourth?.

Well I would like to say that nothing has fallen back, some things have moved forward and I don't want to be more specific on that, I am sorry Ren..

Just a maybe a couple of related questions, when you are evaluating CPMs within your portfolio and given how competitive the space is, do you go and compare it to other established players or products or molecules that are out there, either approved or in development or how do you go through the process of choosing what you believe will be the best, sort of the best-in-class? And then related to that, are there any thoughts in working with or identifying markers, bio-markers which may either improving patient selection or somehow helping in identifying those criteria which could lead to a better response rate in patients?.

Just a maybe a couple of related questions, when you are evaluating CPMs within your portfolio and given how competitive the space is, do you go and compare it to other established players or products or molecules that are out there, either approved or in development or how do you go through the process of choosing what you believe will be the best, sort of the best-in-class? And then related to that, are there any thoughts in working with or identifying markers, bio-markers which may either improving patient selection or somehow helping in identifying those criteria which could lead to a better response rate in patients?.

And I think those are good questions.

So the way that the selection criteria for advancing a compound into anti-enabling studies works here, is that we set minimal standards which we believe allow us to have a development or compound that has the right pharmacologic and pharmaceutical properties and for which we believe we will have freedom to operate in patent coverage.

We do in every case make of all the competitor molecules, so we in the case where we can get the sequence we make the genes, we make the anti-bodies, we purify them up you test them, we understand exactly how they interact with the targets and how our compounds interact with the targets, we know how they act on cells, we know how they act on receptors and their activities with respect or ligand blocking or not ligand blocking and all the things they do on toward going and/or signaling, they are very thoroughly characterized.

Now in most cases you can't do a lot of work with your actual antibody in mice say because most of the time antibodies are cross-reacting so could you work with surrogate antibodies but those are actually only through glass darkly in terms of information.

And then we basically also in some cases we think we have products that are as good or better than the competitors, sometimes we think we have alternatives to the competitors because for these combination regimens.

You may have some of these products which are foundational, you need to have them, you just need to have your own thing you can advance and do the combinations you need to do.

Not every component of your eventual combination has that superior properties but they don't have to have high quality performance properties and some of them will superior and a lot of this is about how you combine them, how you dose them, how you schedule them, in which tumors you go in and as you pointed out your ability to appropriately identify the patients who might respond by way of biomarkers that you can identify or base line monitoring that you perform.

So we are looking at an integrated solution that allows us to do all those things from high quality..

I think this is a very critical point Ren because, up until the acquisition of 4-Antibody, we did not -- we had the vision but we did not had the flexibility to do the kinds of things that Dr. Stein is talking about, now we do. Whether or not a compound will be a look alike or a better one in the context of combinations may not measure as much.

As long as we have the flexibility to advance the program and get the answers that we would like to get that would be a terrific advantage for us and that's why we are very pleased to have this combination of assets to be able to play within the same box. .

Okay.

And does the platform allow for biomarker identification or for moving forward with a biomarker platform or would you need to collaborate with a biotech company that's specializes in that?.

Okay.

And does the platform allow for biomarker identification or for moving forward with a biomarker platform or would you need to collaborate with a biotech company that's specializes in that?.

Well so there are a number of companies that have approaches that can be complementary to what we are doing but we are building our own translational capabilities.

We have a lot of it because the company has been in the immuno-oncology space for two decades and has come way up the learning curve on how to analyze the situation in the patient at the time of presentation and how to follow the evolving interaction between the immune system and the cancer in a particular patient way up the learning curve.

And there are a number of companies like Adaptive that do things like T-cell receptor spectratyping that can be helpful. So we are making use of our own internal expertise and then interfacing with many outside groups that provide useful additional insights..

Just on the liquid question regarding GSK and the filing, can you just give us a sense as to because this is a global filing, how approvals occur and when the first approval may happen?.

Just on the liquid question regarding GSK and the filing, can you just give us a sense as to because this is a global filing, how approvals occur and when the first approval may happen?.

Are you talking about the malaria program?.

Correct, correct..

Correct, correct..

Okay. So malaria program is filed with the EU because the EU will be the key catalystic trigger for approvals by country in Africa. In other words EU and world health organization provide the overriding standards by which the African countries can incorporate this vaccine into their own prophylactic regimen.

So the vaccine, at least this version of the vaccine will not be globally marketed, it would be strictly for Africa, because it is the strain incorporated in the antigenic profile of the vaccine that specifically targets the African malaria. So EU approval will basically trigger a whole host of country allowances.

And Bob, do you want to comment on that as well?.

I just want to say something. So the process is important and goes right in highlighting that. The other thing to bear in mind is as was mentioned, 600,000 kids die every year of malaria in Africa. This vaccine is effective in about 50% of vaccinated individuals. So it has the potential to save 3,000 children's lives a year or 1,000 kinds a day almost.

So sooner it gets approved the better..

And I guess just timing wise, do you know how long the EU, European agency could take to review this?.

And I guess just timing wise, do you know how long the EU, European agency could take to review this?.

I mean it's just very conceivable to expect actions next year as mid next year..

It is just case process but the data are quite good and need is very large and very serious and I expect it to be looked at quickly..

Just one final question, are there any other data presentation, I know I ask this every call, I just want to make sure that it's not happening and any data presentations or thoughts of presenting data by the end of this year at any of the upcoming conferences?.

Just one final question, are there any other data presentation, I know I ask this every call, I just want to make sure that it's not happening and any data presentations or thoughts of presenting data by the end of this year at any of the upcoming conferences?.

Not by the end of this year but certainly there will be disclosures or additional information sometime next year..

Our next question comes from the line of Mike King at JMP Securities. Please go ahead..

Sort of related to the some of the other questions that have come before but just wanted to know what you guys would characterize as your competitive advantage. In other words a lot of folks who are working on immune checkpoint targets, a lot of folks can do antibodies.

I mean it realms to the point now in antibody technology where high school kids are doing in their biology class.

So what is the Genesis/4-Antibody's competitive advantage, why would Merck come to you guys to design antibodies for their checkpoint targets when they could, they have dozens of other choices that they can turn to?.

Sort of related to the some of the other questions that have come before but just wanted to know what you guys would characterize as your competitive advantage. In other words a lot of folks who are working on immune checkpoint targets, a lot of folks can do antibodies.

I mean it realms to the point now in antibody technology where high school kids are doing in their biology class.

So what is the Genesis/4-Antibody's competitive advantage, why would Merck come to you guys to design antibodies for their checkpoint targets when they could, they have dozens of other choices that they can turn to?.

That's a very good question, because to some extent making an antibody of some sort is somewhat commoditized but it's less so than you might expect.

And since Merck has access easily to the yeast-based display technologies and yet they chose to not only enter into an agreement with us but then enter into agreement which carries substantial milestones and meaningful royalties.

And so their due diligence suggests that the ability to make fully human monoclonal that have the right pharmacologic properties.

And then which also are readily developable, because they have very good pharmaceutical properties, in other words expression levels, the propensity not to aggregate, heat stability, immunogenicity, et cetera, is still a significant advantage.

The other piece is this that in the checkpoint space where you’re buying can be very important both for function but also intellectual property reasons. And we have a very good ability to understand exactly where our antibodies buying into screen for antibodies with the properties we want.

Our approach doesn’t require immunization which makes it something like face display or yeast-based display, but then we don’t have all the downstream problems of converting to something which can be scaled up for development.

So if you immunize you are going have a harder time recognizing functionally conserved portions of target antigens because they’re seen itself by the mouse even if the mouse is carrying a human immunological repertor.

So we have the opportunity to have antibodies that are high quality, high-affinity but still interact with crucial portions of these target proteins. So the other thing we have is very good ability through analog around any given antibodies that we’d pull out.

So the way medicinal chemistry works on finding initial hits and then you make many variants on that, this platform is especially good at doing that as well. So I think that as I have gotten to work with it over the last 10 months, I have seen more and more real functional advantages that are more than bullet points on a PowerPoint slide.

They are actually practical and real ways in which this facilitates getting the high quality compounds..

And then just to be clear I heard Bob you said that first Merck candidate may hit the clinic, may file an IND end of ’15.

What about any Agenus proprietary checkpoint inhibitors?.

And then just to be clear I heard Bob you said that first Merck candidate may hit the clinic, may file an IND end of ’15.

What about any Agenus proprietary checkpoint inhibitors?.

If I left that impression that’s not what we meant to say, first of our candidates our proprietary internal candidates, Merck we don’t want to make any public statement about when those might reach IND filing but that’s an earlier program than our internal programs..

Yes, so just to be clear our internal program, our leads expect that it to hit the clinic by the end of next year, IND filing by the end of next year..

I understand the difference..

I understand the difference..

Usually it’s 30 days..

There are no further questions at this time. Please continue..

Thank you, Operator. I would like to remind listeners that a replay of this call will be available approximately two hours after the call and that the call will also be accessible from the Company’s Web site at www.agenusbio.com. On behalf of the management team at Agenus, I would like to thank everyone for joining us on today’s call.

I will be available to receive any further inquiries following the conclusion of this call. With that operator please conclude the call..

Ladies and gentleman, this concludes the conference call for today. We thank you for your participation. You may now disconnect your line and have a great day..