Agenus' (AGEN) CEO Dr. Garo Armen on Q1 2014 Results - Earnings Call Transcript

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Agenus Inc. (NASDAQ:AGEN)

Q1 2014 Results Earnings Conference Call

May 8, 2014 11:00 AM ET


Jonae Barnes - Vice President, Investor Relations and Corporate Communications

Dr. Garo Armen - Chairman and CEO

Dr. Robert Stein - Chief Scientific Officer

Christine Klaskin - Vice President, Finance


John Sonnier - William Blair

Jason Kolbert - Maxim

Graig Suvannavejh - MLV & Co.

Ren Benjamin - H.C. Wainwright

Mike King - JMP Securities


Good day, ladies and gentlemen. And welcome to the Agenus First Quarter 2014 Earnings Conference Call. As a reminder, today's conference is being recorded.

At this time, I would like to turn the conference over to Jonae Barnes, Vice President of Investor Relations and Corporate Communications. Please go ahead, Ms. Barnes.

Jonae Barnes

Thank you. Good morning, everyone, and thank you for joining us. Welcome to Agenus conference call to discuss the first quarter 2014 financial results. With me today is Dr. Garo Armen, Chairman and Chief Executive Officer; Dr. Robert Stein, Chief Scientific Officer; and Christine Klaskin, Vice President of Finance. 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.

But before we 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 the 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 replay.

With that, I will now hand the call over to Christine who will review our first quarter 2014 financial results.

Christine Klaskin

Thank you, Jonae. Good morning, everyone, and thank you for joining us on today’s call. Some of the statements I will be making are also contained in the press release issued this morning.

We reported a net loss attributable to common stockholders of $409,000 or $0.01 per share for the first quarter of 2014, compared with a net loss attributable to common stockholders in the first quarter of 2013 of $8.8 million, or $0.35 per share.

In the first quarter of 2014, we recorded a non-cash income of $9.9 million related to the impact of the termination of GSK’s Phase 3 MAGE-A3 trial in non-small cell lung cancer.

In the first quarter of 2013, the company’s preferred stock restructuring, which reduced the dividend requirements for its Series A-1 preferred securities, resulted in a non-cash deemed dividend of $2.9 million.

Cash and cash equivalents were $73.5 million as of March 31, 2014 and based on our current plans and activities, we expect sufficient financial resources to fund our operations through the middle of 2015.

This concludes the financial portion of the call. Dr. Armen will now provide a corporate update.

Dr. Garo Armen

Thank you, Christine. As you are aware the highlight of our first quarter was the acquisition of the 4-Antibody Corporation. Since the announcement of this transaction, we have advanced our company on several fronts.

First, we completed a financing which net of Agenus $56 million, participants were among the premier healthcare biotech investors. Second, we selected several checkpoint antibodies for IND enabling development. Third, we signed our first major pharma collaboration in the checkpoint field.

In addition, we defined our business plan for optimizing the opportunities of our checkpoint modulator assets and Retrocyte Display technology platform. And we also successfully advanced the integration of the 4-Antibody with the Agenus team.

As we all know, the excitement around the checkpoint field continues to mount. For the first time ever, we are seeing patients who do not respond to conventional treatments and whose cancers are otherwise incurable benefiting from these new treatments. What this mean is that there is a growing belief that our -- that for the first time ever we may have started the process of cracking the code for defeating cancer.

The substantial progress in the checkpoint field was a parent at the American Association of Cancer Research Meeting last month. There is much more expected at the upcoming ASCO meeting, the world’s largest Clinical Cancer Conference that will be held in early June.

All of this substantiate and validate our commitment to the field of immuno-oncology, particularly now that we have a much more complete toolset to enable us to succeed then at any point in our history.

So to be clear, we believe that our antibody platform and our checkpoint modulator pipeline along with our vaccine platform puts us in a very unique position to benefit from the significant developments in the field and they represent a tremendous opportunity for us hence our advancing our programs in a very deliberate and very focused manner.

Getting back to the specifics of our business, during the short period of time since our acquisition, we have selected three checkpoint modulator antibodies to advancing to -- IND enabling studies. These are two GITR agonists and a CTLA-4 antagonist.

We also entered as we said into a strategic collaboration and license agreement with Merck. Merck has become a leader in the immuno-oncology field, especially with the rapid progress they had made with their PD-1 inhibitor, which is currently underway for review at the FDA.

Our agreement, Merck, involve discovering and developing antibodies for two of their novel checkpoint targets. We believe our Retrocyte Display technology has advantages over other platform technologies and one of these advantageous is the potential to deliver fully human best-in-class antibodies. We are very pleased that Merck has selected to work with us with our platform technology.

Furthermore, the Merck partnership is part of our three-prong business strategy to advance our checkpoint modulators and strengthen our participation in this fast moving immuno-oncology space.

The first of these strategies is comprised of internally developing select checkpoint modulator candidates, with our expertise in immuno-oncology and our resources, we plan to advance a select number of our checkpoint antibody programs to important -- inflection -- value inflection points such as clinical proof-of-concept.

Our development strategy includes advancing our emerging portfolio of checkpoint modulators as single agents and also in combinations including potential combinations with our anti-vaccine -- anti-cancer vaccines and other agents for which there is a strong rationale for synergistic effect.

Our strategic focus will include attention towards niche and underserved cancer indications that may offer fast development and registration opportunities aligned with attractive commercial potential. We intend to file one or more checkpoint modulator investigational new drug applications in 2015. And we plan to enter human clinical studies in 2016.

The second of our three-pronged business strategy is to establish synergistic checkpoint target-based collaborations to leverage our discovery platform and to broaden our exposure in immuno-oncology. The recently announced agreement with Merck is one example of a value-added pharma partnership.

In this collaboration, we will use our Retrocyte Display antibody platform to create novel checkpoint modulators against tumor targets for Merck to advance through development. Success with these targets could be lucrative and would trigger milestone payments of approximately $100 million as well as worldwide royalties on product sales. Using this business model, we will continue to explore additional opportunities for our Retrocyte Display platform, which we believe can create best -- as we said in best-in-class antibodies against a wide range of checkpoint and non-checkpoint targets.

For our third-pronged approach, we will elect to partner specific candidate in our checkpoint modulator portfolio. And currently there is a very high level of partnership interest in our emerging checkpoint modulator portfolio. And currently we are in active discussions with several companies.

To sum up, we now possess a diverse immunotherapy portfolio of checkpoint modulators, anticancer vaccines and adjuvants, including several late-stage development programs by GSK. As you also know, during the first quarter we experienced a disappointment with GSK’s Phase 3 MAGE-A3 lung cancer immunotherapeutic trial, which contained QS-21 Stimulon. GSK stopped the trial. Actually it did not meet primary end points in non-small cell lung cancer patients.

In conclusion, we are fortunate that amongst us and our partners, there are 22 programs in clinical development. And I look forward to reporting progress in several areas going forward, including the anticipated regulatory submission for GSK’s malaria vaccine candidate this year. And as you know, this candidate contains QS-21.

At this point, let me turn the call over to Dr. Robert Stein, our Chief Scientific Officer for a much more in-depth review of our recent research and development programs. Dr. Stein?

Dr. Robert Stein

Thank you, Garo. We are very excited to be developing a broad portfolio of immuno-oncology candidates and in particular our checkpoint modulators or CPMs. The CPM field is rapidly evolving and we are greatly advantaged in our pursuits our close collaborations with premier translational research and development leaders in the field.

These include the Ludwig Cancer Research Institute and through this relationship, Dr. Jedd Wolchok, a true leader in immuno-oncology discovery and development of therapies for cancer. Exciting new insights emerging from translational research allow immunologic assays to assess whether CPMs are displaying signs of potential therapeutic activity long before clear efficacy signals are observable.

Through translational research, a new approach has been developed to assess therapeutic activity in patients being treated with CPMs. For example, traditional imaging techniques alone can frequently suggest the patient's tumor is progressing when in fact it is regressing.

Learning to assess patient’s responses to immunotherapies has been a major step forward in applying checkpoint modulators to successfully control cancers. We are working with pioneers in this effort that have established a new set of criteria to measure responses to immunotherapies.

Through this promising work, a new paradigm is being established. It transforms the risk profile to clinical development in the checkpoint modular field from other forms of therapeutic modality by providing the potential to confirm both mechanism of action hypotheses as well as detect early science of therapeutic activity in Phase 1 studies.

Previously, such approaches probably would have been attempted in more extensive Phase 2 studies. This new paradigm should help to advance our CPM programs through clinical development more intelligently and more rapidly than previously possible.

At ASCO last year, we’ve shown that applying these techniques could be used to demonstrate compelling evidence of the benefits of combining two checkpoint modulators in the same treatment regimen. Yervoy or ipilimumab was combined with another ipilimumab in melanoma and in doing so has arguably accelerated development of combination CPM approaches in the exploration of novel treatments for cancer.

In addition, at this year's American Association for Cancer Research’s scientific discussions highlighted exploring CPM combinations of agonist and antagonist and included our checkpoint targets GITR and OX40. A takeaway message from this meeting was that combination therapy will allow immunotherapy to achieve its full potential.

To date, we have been able to generate multiple preclinical checkpoint antibodies, targeting various important checkpoint proteins, including clinically validated targets such as CTLA-4 and PD-1 as well as four emerging targets for its strong preclinical validation has been achieved. These include GITR, OX40, LAG-3 and TIM-3. These target checkpoint molecules regulate immune responses to cancers and other diseases.

Among the targets that have received the most attention are GITR and OX40 and multiple companies have shown interest in these programs. This is because GITR and OX40 play an important role in amplifying specific cellular immune responses including those against tumors and are expected to tip the balance towards tumor destruction and away from immunosuppression. Many companies are seeking antibodies which activate these receptors but finding them has proven difficult.

We are planning to develop our CPMs both as monotherapies and also in combinations that include combinations of our own CPMs as well as combinations of our CPMs with other drugs. By utilizing the sophisticated immunological assays in early-stage clinical trials to generate combined signals of initial activity together with confidence-building mechanism of action data, we anticipate we will successfully be able to apply these new translational approaches to speed clinical development while reducing late stage development risk.

In addition to our own programs, we are now working with Merck on two novel checkpoint targets that they identified for cancer immunotherapy. Merck is a world-class research partner and a leader in the rapidly developing immuno-oncology field. This collaboration will benefit from the advantages of the Retrocyte Display platform for generating fully human antibodies.

Our proprietary platform uses B-cells to generate antibody candidates and we believe that therapeutic antibodies generate using our platform will demonstrate better pharmaceutical properties and therefore, have a stronger chance of being developed into successful drug candidates.

We believe that 4-Antibody Retrocyte Display platform represents a significant driver for value creation and going forward, I anticipate reporting additional progress with this power platform.

Turning to our heat shock protein based vaccine platform. We reported during the fourth quarter, preliminary results for our Herpes B Phase 2 trial, evaluating viral shedding in patients with genital herpes simplex virus infections.

We expect to report the final data, which include the results of a booster dose by the end of the second quarter of this year. Herpes B QS-21 Stimulon and 32 HSV-2 derived immunogenic peptides. Possible future efforts to partner Herpes B will be based on these data.

Finally, last year, we announced the initiation of enrollment in a large randomized NCI sponsored Phase 2 study of Prophage vaccine in combination with Avastin for treatment of recurrent glioblastoma multiforme. Initiation of the trial by the NCI was the validation of our vaccine and technology. Enrollment in this trial has been slower than expected and we are diligently working with the Alliance to help address the delays.

I am very excited to be firmly positioned in the rapidly evolving checkpoint modulator field. We truly believe that this area of research is one of greatest steps forward in developing effective treatments for patients with cancer.

I’ll now turn the call back over to you, Garo.

Dr. Garo Armen

Thank you, Bob. Just to conclude this call, through our own efforts and those of our world-class partners like GSK, Merck. We remain committed to advancing immunotherapy product candidates. We believe that we are uniquely positioned to help create a new generation of immunotherapies that have the potential to dramatically improve outcomes and quality of life of patients battling cancer. We hope that you have found this update helpful. And I will now conclude my remarks.

Christine Klaskin

Operator, we will now turn the call over to the question-and-answer period.

Question-and-Answer Session


Thank you. (Operator Instructions) And the first question is from John Sonnier of William Blair. Please go ahead.

John Sonnier - William Blair

Thanks for taking the question and thanks for -- and congrats on all of the progress you guys have made. I wanted to ask -- I guess, this is probably a question for Bob. It’s a bigger picture question. Looking into ASCO, I think the street focus to a large extent on the combination studies, CheckMate studies out of Bristol. I think will have the largest datasets combining two checkpoint inhibitors and perhaps a continuation of what we saw last year on melanoma but in the long setting with CTLA-4 and PD-1.

And so it does raise the question as to how these combination trials with different checkpoint inhibitors influence the way you prioritize the pipeline, especially those proprietary candidates that you mentioned during your prepared commentary, A. And B, as far as I can tell, it seemed to date it is predominantly combination work on the inhibitory receptors. Are you aware of anything that might be at ASCO, looking at agonizing and activating receptor with something like Yervoy or PD-1? Thanks.

Dr. Garo Armen

So, John, it’s a good question. It’s clear from a variety of preclinical studies that combining some of the agonists like GITR agonist or OX40 agonist with some of the unblocking checkpoint modulations can have very powerful benefits. It’s a little early for those data to be reported in the form of clinic, but we anticipate that that type of activity will emerge very powerfully over the next several years.

In the recent, Merck R&D Day, they highlighted the combination of GITR agonists with either PD-1 or LAG-3. And I think that it will be clear that not only they have used data in important preclinical but the clinical studies will be built to explore that very early in the assessment of how these things work to benefit patients optimally.

John Sonnier - William Blair

That’s helpful. I think one of the things that also came up a little bit more prominently than I heard previously in the Merck R&D day was the topic of biomarkers and my recollection was at ASCO last year, there wasn't a clear association of PD-1 expression levels in response. But how big a question is this in the area of biomarkers in these early stage collaborations like the one you just did with Merck? Is this something that is of interest in identifying upfront side, maybe in front of the -- the onset of clinical activity just, the design of a strong and sensitive assay?

Dr. Garo Armen

I think that there are two pieces. One is to develop appropriate pharmacodynamic assays pre-clinically and they will be using that in conjunction with the efforts in the Merck collaboration. We are also working very diligently on that in our own programs, both in-house and through our collaborations with Ludwig and Jedd Wolchok’s lab. This is a key aspect of being successful in this field is to develop the effective translational approaches to be able to appropriately baseline people, select therapies based on the assessment of their baseline degree of tumor recognition by the immune system and the extent to which they have erected various anti-tumor or anti-immune defenses. And then to be able to pullout efficacies signals earlier because a lot of these actionable improvements take a long time to manifest and you want to be able to track on the right therapeutic regimen or not yet, both important for the development phase and for the eventual clinical deployment of these interventions.

John Sonnier - William Blair



Thank you. And the next question is from Jason Kolbert from Maxim. Please go ahead.

Jason Kolbert - Maxim

Hi, guys. Great. I have two quick questions really. One is financial and one is clinical. And on clinical, can we focus a little bit on glioblastoma and kind of what things can you do to help enrollment? When do you think that trial might be fully enrolled? We are still very excited about the potential. And I just wondered if you could expand a little bit on kind of where you’re at in GBM, as there has been a lot of controversy with the other companies. And just the financial question I have is a simple one is, you have a non-operating income and it looks like positive 9466, what is that number?

Dr. Garo Armen

Okay. Let’s address the financial part first, because it’s simple. The number is strictly based on the fact that our GSK trial failed, and that our presumed future obligations to Ingalls & Snyder in the context of having restructured disagreement now goes away, at least the lung cancer component of that obligation goes away. And so, by some accounting measures, which are very difficult for the common man to understand including myself, that is reported as a gain.

Jason Kolbert - Maxim

Garo, I feel your pain.

Dr. Garo Armen

Okay. So, that’s the easy part. The second question is a little bit more complicated with regard to onco phase. There are two parts to this question. But to let me answer the question in a very succinct way, and say that within the next 1.5 month or 2 months, we will be able to give you a much more detailed answer to that question. And reason is, we are in the midst of now studying, evaluating, trying to figure out how all of these can be done. But aside from all of that, we will also take into consideration the fact that the landscape is changing very rapidly.

Bob has been spending a lot of its time in trying to figure out how all of these biomarkers and additional preclinical and clinical data that is coming out will affect future treatment paradigms, because what we need to do is make sure that whatever we will do today is going to anticipate what the landscape is going to look like in terms of the standard of care 2, 3, 4 years down the road. And so that too is being factored into our crisis.

And so not to complicate this any further, are there ways in which enrollment can be helped in the trial? The answer is probably yes, but I will have a clear picture on this in the next six weeks or so, because it’s a collaborative effort between us, alliance, the NCI and other parties. And will we be able to give you better guidance in terms of what will happen with enrollment or what will not happen with enrollment six weeks from now? The answer is yes.

Jason Kolbert - Maxim

Okay. I think that’s really important, right, I mean, as an analyst, right and as that -- that has the potential to be very transformative for the company. We’ve really looked forward to getting together with you in some forum and just having better clarity as to how that trial might evolve over the next year or two. All right. Thank you so much.

Dr. Garo Armen



Thank you. The next question is from Graig Suvannavejh of MLV & Co. Please go ahead.

Graig Suvannavejh - MLV & Co.

Good morning. Thank you for taking my questions. Congrats on the progress that you have made so far this year. I had a question just on given the changes that are happening with large-cap pharma and your relationships with GSK look like it will change somewhat. And I was wondering, could you give us a sense of your interactions both with the GSK folks as well as any interactions you may have had with the Novartis folks, any characterization of how this partnership evolving? Thanks.

Dr. Garo Armen

Okay. So this could be clear. The transaction between GSK and Novartis doesn’t have any bearings at all on our QS-21 aggression, okay and now certainly not directly. Meaning no asset that is going to Novartis will involve any programs that have QS-21 in them. Now there is indirect effect and the indirect effect is the silver lining in the aftermath of the MAGE-A3 failure in lung cancer and that is as follows.

As you may have assumed before the GSK QS-21 containing MAGE-A3 lung cancer failure, GSK was heavily betting on their vaccine operation being skewed to therapeutic vaccines, specifically cancer vaccines. Now that has changed and that change is also amplified by the transaction between Novartis and GSK in emphasizing their prophylactic business, whereas prophylactic business was in sort of the second stage, now it’s become the first stage. And that has certainly benefits for us in how the prophylactic vaccines programs are taking forward, how aggressively they are taken forward and how important QS-21 becomes in their prophylactic vaccine portfolio.

Now we don’t know exactly what Novartis preclinical prophylactic programs or clinical prophylactic programs will be pursued by GSK. But suffice it to say that the exposure to QS-21 could potentially grow because of this transaction between the two companies. In terms of what it means to us, well the failure of the MAGE-A3 trial in non-small cell lung cancer was certainly a set back because that would have potentially mean significant royalty income for us in the near term. But what this renewed emphasis on prophylactic vaccines by GSK would mean to us is a much more diversified portfolio that is now in the center stage and will be more aggressively pursued by the company. And that’s why some of these diversified prophylactic vaccine programs may come to fruition quicker with more resources by the company and that could mean a much more diversified exposure to us with regard to QS-21 royalties going forward.

Graig Suvannavejh - MLV & Co.

Okay. Thank you very much. I appreciate that color. And I just asked a second question and again congratulate upon your recent operation deal with Merck. If you could help us get a sense of how that collaboration came about in terms of Agenus and how long it took to complete that? And as follow-up, how active is Agenus being in pursuing similar like collaborations and vice versa, how proactive are partners coming and calling on you, knocking on your door to gain access to your technology? Thank you.

Dr. Garo Armen

Strictly for the CPM programs, we're talking about, right?

Graig Suvannavejh - MLV & Co.


Dr. Garo Armen

So the Merck collaboration was in early stages of development when we were having our final discussions with for antibody, and they moved into high gear shortly after we completed the transaction. Merck had been quite interested in using our technology platform to find antibodies to fish out antibodies to these targets. And we are very gratified and very encouraged by the fact that they to regard our technology platform as having some unique advantages over others out there, because that is our belief and it's one of the reasons we consummated the transaction. And if you look at our Retrocyte Display platform, people say, is this a speculative platform? And the answer to that question is absolutely not, because in the short period of time we've already been able to identify antibodies that are at least as good if not better than current antibodies that are being pursued in the CTLA-4, PD-1, GITR (indiscernible) and so on and so forth.

So we are a very unique company in the sense that we have an engine that can generate antibodies to essentially any target that we specify and though the antibodies have some inherent advantages because not only are they fully human antibodies, but they also because of the fact that we use the b-cell engine platform to make them, they are pharmaceutically appropriate antibodies. So that means if they will require any post-discovery engineering -- reengineering, that generally those will be modest, if any.

Okay. So that's the background. With that background, we also, as you know, have programs for the discovery. And in fact by the end of this year, we should have all six of our checkpoint targets identified by the end of this year. And so we have a very diversified group of checkpoint targets that are in the forefront of interest by major pharma in the field. And that's why in my statement, I made it very clear that not only is there a significant level of interest by several companies in the big pharma or big biotech circle. We are in with some advanced discussions and with others in early discussions. But I anticipate that by the end of this year, we will either have an agreement in place that will be a partnership with one or more of these candidates and/or we will give you a much more deliberate direction on when those agreements will be consummated. But there is a realistic chance that we will have additional agreements in place by the end of the year.

Graig Suvannavejh - MLV & Co.

Okay. Great. If I can just make one last quick follow-up, I'm curious about your comments about the quality of the antibodies versus what is already out there. Have you shared that data before, and if not, when would you anticipate sharing data where you could…

Dr. Garo Armen

We have not shared that data and what I'm saying is a statement based on some early exploratory studies. It's based on also the fact that we have a group of professionals in Europe that know a considerable amount because of their background on what constitutes a successful or what constitutes a good antibody that can get the job done. So based on that, I think, it would be premature for us to share anything publicly, part of the reason is the data set is not complete yet.

Graig Suvannavejh - MLV & Co.

All right. Thank you so much and again congrats on the quarter.


Thank you. The next question is from Ren Benjamin of H.C. Wainwright. Please go ahead.

Ren Benjamin - H.C. Wainwright

Hi. Good morning and thanks for taking the questions. I guess, one quick one for, Bob, you had mentioned the update on the randomized Phase 2 trial that enrollment was going slower? Can you give us some more color as to why that might be?

Dr. Garo Armen


Dr. Robert Stein

Yeah. Well, there are a couple of things, the clinical patent abuse for Avastin is being somewhat challenged by recent data that have been released suggesting that the benefit may or may not be there and some people feel there may actually be some harm. So, automatic use of Avastin under the current GBM setting is not really so automatic anymore, that's one piece of it.

And we are doing some things like the recent edition of the radiation oncology therapy group has given us more sites in which we can recruit. But we are in the context of somewhat changing clinical practice and the study was designed for standard of care which maybe modified shortly as people [Technical Difficult] be on Avastin.

Dr. Garo Armen

So as I said during my call, bear with us in the next six weeks, we'll have much more clarity for you.

Ren Benjamin - H.C. Wainwright

Okay. And then just regarding the Merck collaboration? Can you talk us through or provide a little bit additional color on the specific, I guess, the financial specifics, clearly we know the total amount here, I believe there is none upfront? But can you give us a sense as to how these milestones will be recognized? And my understanding also is that outside of the milestones the development of these novel antibodies is actually being covered by Merck? Could -- can you just verify that, if I'm right or correct if wrong?

Dr. Garo Armen

Yes. I think you stated it correctly. So we do not incur any cost associated with this agreement internally. All of the cost plus some are covered by Merck. And in terms of the milestones, I'm sorry that I'm not at liberty to provide more granularity because that is not public information and we haven't disclose -- and they haven't disclosed it.

Ren Benjamin - H.C. Wainwright

Okay. I guess just as a follow-up to that question, would you be able to help us understand about how much the development cost could be, as you bring these two antibodies forward?

Dr. Garo Armen

Well, okay, actually the stage one of that is the cost of the delivering antibodies to Merck and that will be in the order of several million dollars. And as I said, we will not incur any cost associated with that process, internal or external costs. So we have no cost associated with it.

Once we deliver the antibodies to them, they take over the entire process. So in terms of IND enabling studies and development costs and development program that becomes entirely in their own domain and so beyond the delivery basically this is basically an annuity for us, because milestones will be accrued and delivered to us based on their success at various time points.

And in terms of royalties that will be post-commercialization and during that period, once the antibodies are delivered to them, honest, we will restructure the agreement for some unforeseen reason, the entire effort is going to be undertaken, so we have no costs or anything else to go with beyond that point.

Ren Benjamin - H.C. Wainwright

Excellent. Okay. And just one final question regarding the GSK non-small cell lung cancer trial and any potential read through that are still ongoing melanoma study. Off the bat, I would think that given the different indications, the fact that although both have the gene signature maybe they are saying something more regarding the gene signature of patient population in the melanoma trial over non-small cell. But is there any sort of conclusions we can make or how should we be thinking about the melanoma program going forward?

Dr. Garo Armen

I will give you my own sense of things. And I want to qualify because this is not based on any guidance from GSK or anybody else. So our disappointment is certainly the fact that this trial had no really basis, non-small cell lung cancer trial to be continued or to be further analyzed because there really wasn’t any reason for it. And so they -- that’s why then terminated it.

Now as far as the melanoma trial lead outs with the gene signature that’s ongoing, no question about that. However, I worry about it only because the gene signature was supposed to be a general criteria -- a generic criteria across any indication. It wasn’t suppose to be indication specific that was the spirit with which this was undertaken because you’re measuring the patient’s ability to monitor in new response to their specific cancer.

So why there’s always a possibility that the gene signature data for melanoma will be positive. I worry about the regulatory acceptance of that for specifically melanoma indication. It would have been easier for the regulatory authorities to make a case that this is a generically applicable gene signature and that it would be regulatorily submissible. But we don’t know. We don’t the answer to that question and there’s a big question mark now. So that’s one of the reasons we will not expect much or speculate about the outcome over the gene signature trial in melanoma.

Ren Benjamin - H.C. Wainwright

Excellent. Thank you very much and good luck going-forward.

Dr. Garo Armen

Thank you.


Thank you. The next question is from Mike King of JMP Securities. Please go ahead.

Mike King - JMP Securities

Thanks for taking my question. Garo, as I listened to the discussion here today, I’m just kind of struck by the thought that in my personal opinion, you may not agree. But it seems like here the company would be best off focus completely on the checkpoint antibodies.

Because it just seems like MAGE creates a lot of controversy and a lot of question. I’d say the same is true for Prophage. Why not move away from sort of legacy products to the new portfolio of technology that you have where investors have clearly said and voted with your dollars with private acquisitions and publicly traded companies that have significantly higher market caps. Just wondering what your thoughts are on that topic?

Dr. Garo Armen

Okay. So you certainly bring up interesting and perhaps even a valid point, Mike. So let me approach it the following way. Are we at a point where we do not any longer value the portfolio of products and technologies comprising heat shock protein technology and our adjuvant technology? The answer to that question is absolutely not, we’re not -- we have no reason to devalue or shut these technologies.

Are we seriously looking at a number of options that emphasizes checkpoint portfolio and platform and looks at means of driving cost down in everything else? We’re looking at those options right now. Okay. Looking at those options and I think we’ll have more clarity in the next months, not in the next quarters but next months on that.

Now, we do believe that we have a very attractive vaccine platform technology. Now that attractive vaccine technology platform needs to be reconsidered in the context of the other tools that are available to us. And we need to think through what is the most effective way of turbo-charging our portfolio products and technologies collectively. And that may require some resetting of the efforts that are ongoing. And so, if you look at our priority right now, number one, checkpoint portfolio is use to add -- has been voted on by investors because the majority of our investors that came in our last financing were fixed on the checkpoint portfolio and the opportunities there and certainly the validation by Merck with our technology platforms adds to it.

Certainly, the ability to have identified several of our initial candidates’ checkpoint, antibody candidates certainly validates that and all of these things have happened post (indiscernible), right. So that’s one aspect of it. That deserved emphasis and it will be getting disproportionate amount of our attention. The second bucket perhaps that we think to is, how do we contain our cost in everything else so that our burn rate is modest? Modest because we contain our cost in everything else and we bring in additional partnerships that will help further diminish our burn rate.

And ideally, completely extinguish our burn rate. And so we’re working on those programs. We’re working on how do we do that? And the third piece is, many years ago, when we had a meeting with the FDA post-renal cell carcinoma data, at least one individual at the FDA. This was an informal meeting because as you know, we never went for approval of the renal cell carcinoma program.

When we had that meeting, one individual was a pretty high-ranking official said, I believe your vaccine is doing something important here. I wish there was a way of turbo-charging that vaccine. And so for many, many years, we have been on the lookout for the right pairing with our vaccine to turbo-charging it.

It’s not a secret that we’ve borrowed, try to borrow and beg for getting access to CTLA-4 and PD-1 to do combination trials and so on so forth. But it hasn’t happened because we’re not in control. Now that we’re in control with not, one or two, but many checkpoint potential candidates, should we then consider, how do we turbo-charge our vaccine program with some combinations and that’s going to require some certainly science and early development work.

And so we’re going through this process of evaluating how alone this should be done, while with a very, very deliberate intent to make sure that our costs associated with that early or with any of the programs outside of checkpoints is moderated. Does that answer your question?

Mike King - JMP Securities

Yeah. But I mean, we can have a longer discussion offline about it. Thanks, Garo.


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

Jonae Barnes

Great. I would like to remind listeners that a replay will be available approximately two hours after the call through midnight Eastern Time on July 8, 2014. The replay number is 416-915-1035 and the access code is 571716.

The replay will also be available on the company’s website approximately two hours after the live call. Do you have any additional questions, please feel free to call Investor Relations department at 781-674-4538. Thank you for joining us today.


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

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