Agenus Inc.
Q3 2009 Earnings Call Transcript

Published: 29 Oct 2009

[Operator:]

Good morning, I would like to welcome everyone to the third quarter 2009 earnings conference call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. (Operator Instructions). Thank you Ms. Sharp, you may begin your conference.

[Shalini Sharp:]

Good morning everyone. Welcome to Antigenics' conference call to discuss the financial results for the quarter ended September 30, 2009. With me today is Dr. Garo Armen, Chairman and CEO. We hope that all of you have had a chance to review the press release that was issued this morning. During this call, we will review the financial results as well as provide a corporate update. We will then have a Q&A session. 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 past position, programs and products in development using QS-21, the company’s application for marketing authorization for Oncophage in the EU, the company’s efforts to market Oncophage in Russia and to pursue named patient and similar programs and the phase II trial of Oncophage in glioma. 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’re disclosed in more detail in our most recent filings with the U.S Securities Exchange Commission. When evaluating Antigenics’ business and securities, investors should give careful consideration to these risks and uncertainties. Before we move on, I would like to note that for the purposes of this call, the phrase, 'net cash burn' means cash used in operating activities plus capital expenditures, debt repayments, and dividend payments. With that, I will now review our financial results for the quarter ended September 30, 2009. For the third quarter of 2009, Antigenics incurred a net loss attributable to common stockholders of $10.8 million, or $0.13 per share. This is compared with a net loss of $11.4 million, or $0.17 per share for the same period in 2008. Antigenics recognized revenues for the quarter ended September 30, 2009 of $896,000 compared with $685,000 during the same period in 2008. This increase in revenue was primarily driven by an increase in QS-21 license fees, royalties and product shipments to a number of our corporate partners. R&D expenses for the quarter ended September 30, 2009 were $3.7 million compared with $5.4 million for the comparable period in 2008. G&A expenses for the three month ended September 30, 2009 was $3.5 million compared with $5.1 million in 2008. Our net cash burn through the third quarter of 2009 was $21.3 million compared with $24.4 million for the same period in 2008. The 2009 results reflect among other things the Company's efforts to support Oncophage in Russia, Europe, and other territories, while also executing cost containment efforts. Having raised net proceeds of $18.6 million through private placements of common stock we had $34 million in cash, cash equivalents and short terms investments at the end of the third quarter. We believe our current cash balances are sufficient to fund our operations into 2011 at our current rate of net cash burn. Finally to-date, we have extinguished $30 million in face value of our 2005 convertible notes in exchange for approximately $3.3 million in cash and 5.6 million shares of common stock, which should result in annual cash interest savings of $1.6 million. This concludes the financial portion of the call. I’ll now turn the call over to Dr. Garo Armen.

[Dr. Garo H. Armen:]

Last week as you know we announced that the European Medicine Agency, the EMEA had advised us at an oral hearing to anticipate a negative opinion on our application for marketing authorization for Oncophage in the treatment of Stage I into high-grade renal cell carcinoma, which is known as RCC. While we are of course disappointed with this outcome we are in the process of evaluating our strategy on how to best go forward with respect to Oncophage in RCC in Europe. This includes pursuing the main patient program in various countries in Europe while simultaneously with this we will also evaluate the risk benefit or withdrawing our application followed by potential re-filing or the possibility of an outright appeal. We along with the number of key specialists who treat these patients remain convinced that there is substantial scientific and clinical evidence which supports the conclusion that Oncophage would provide a meaningful benefit for a large segment of RCC patients. These patients have a significant unmet medical need, particularly given the fact that there are no other treatment options for surgery. It is also important to note that the benefit seen in the earliest stage patient is persistent for a long period of time. We will provide of course with regular updates as we clarify our next steps in Europe. In the meantime pre-launch activities continue in the Russian market. We remain engaged in discussion with the Russian Government regarding potential reimbursement of Oncophage and I realized that this has taken a while. At the same time, we continue with our efforts of enabling local centers of excellence to treat patients with Oncophage by equipping them with freezers integrating Oncophage into their treatment protocols and so on. Once again, we will provide you as we have with better guidance once the time line for launch and market potential in Russia become clearer to us. Moving on to the glioma program, as you also know earlier this week we announced that the principal investigator over Phase II trial in Oncophage in recurrent glioma provided a clinical update at the Society for Neuro-Oncology meeting in New Orleans over the weekend. Data from this first 20 patients enrolled in the trial showed a median survival of approximately 10.1 months when the normal expectation of survival in this patient population historically has been six and half months. Similar patients treated with Avastin, which is the recent standard of caring these patients have shown a median survival of 9.2 months in recent trials. We remain optimistic about the prospect of advancing the development of Oncophage in this area of high, also high medical unmet need. The trial is expected to enroll approximately 30 additional patients. In addition to this trial, we in glioma we have another trial ongoing which is also a Phase II trial of Oncophage with Temodar in newly diagnosed patients and that as I said is actively enrolling now. Turning rather to the QS-21 program. As you are aware there are currently 15 different vaccine products containing QS-21 in clinical by our partners. This includes Glaxo Smith Klein’s Phase III programs in malaria, melanoma, and non-small cell lung cancer. Our key partners also include now JANSSEN Alzheimer Immunotherapy which is a wholly owned subsidiary of Johnson & Johnson which recently acquired substantially all the assets over Elan’s Alzheimer's Immunotherapy Program. As you can see, between GSK, Glaxo Smith Klein and JANSSEN products the portfolio vaccine is containing QS-21 is extraordinarily diverse including more prophylactic and therapeutic vaccines spending a course preclinical Phase I and Phase II and Phase III stages of development and also occurs infectious diseases, cancers, and Alzheimer's disease. We anticipate that the first vaccine containing QS-21 with launch as early as 2001 2012 timeframe we're entitled to royalties on commercial sales for at least 10 years post product launch and potential revenues for Antigenics at peak are in the hundreds of millions of dollars with little or no cost associated with the reutilization of these revenues. Currently, we are reimbursed for any expenses associated with QS-21 on a cost plus basis and additionally we get various milestone payments. We recently renegotiated our QS-21 license and supply agreement which is now held by JANSEEN. This covers the supply of QS-21 for their Alzheimer's disease vaccine which ACC-001. As a result we are in the process of transferring for the wholly owned subsidiary of J&J the technology to supply QS-21 in exchange for modest undisclosed payments. All other royalty obligations and clinical development milestones remain economically equivalent as before. This as you can see is an exciting program for the Alzheimer's disease community and we're pleased that J&J has recognized the potential and has sort to secured supply of QS-21 as a key component of their vaccine.

[Operator:]

(Operator's Instructions). And your first question comes from the line of Ren Benjamin.

[Ren Benjamin:]

I guess first things first regarding the EMEA decision or the opinion. Have you've been able to get any sort of clarity or any additional information as to why they have a negative opinion, if not when might you get that information and what are the sort of choices of going forward. I know you early on the call you mentioned that you could go through some, some of the other countries and the EU and I guess go after them individually, but maybe we can just go through a little bit of a scenario now if you don't mind.

[Dr. Garo H. Armen:]

Sure in terms of your first question as to why they gave us a negative opinion. As you know we filed in October of last year for conditional approval, which is a relatively new provision perhaps about four years old. And there had been a handful of products approved under the conditional approval provision. And we went under that because of specific attributes of the patient population, the unmet medical need, and perhaps the unclear guidance on cancer vaccines in general. It is very, very much a debate, not just in Europe but also in the U.S on how to improve guidance for the approval of cancer vaccines because this is a novel area, it targets a newer patient population meaning typically patients that are not targeted by typical oncology drugs, earlier stage patients. And the guidance in this area is weak at best. And the expectation that these products, in these patient populations should be required to meet the same kinds of requirements as the typical oncology products in late stage patients is an open question. So there are lots of question marks because we’re treading a novel area and the typical requirement for two well-controlled clinical trials that show statistical benefit is something that will have to be clarified and debated in the future. Now having said that, we went in for conditional approval because we had substantial support from the clinical community who were either exposed to Oncophage in the course of the clinical trials or became acquainted with the result subsequently and thought that it would be important to have Oncophage as a, in their armamentarium for battling prevention of recurrence in this patient population that has a relatively high risk of recurrence. So the rules are -for this novel area need to be clarified and they decline the product based on rules that apply to oncology products in general and products for approval in general. Now in terms of our next steps. The country-by-country stockage that I outlined really refers to the name patient program. Name patient program is a special provision in Europe specifically and perhaps in other geographies as well. But in Europe that allows one to be reimbursed for product that had not been approved if physicians request this product specifically for their patients. So the companies cannot go and promote the product as you would for an approved product, but can educate the community and based on that if there are any requests we can fulfill those requests and get paid for the products. And that is a strategy that has been ongoing with us in Europe and we will have to visit this on a country-by-country basis. With regard to the future for Oncophage is approvability in Europe; there are two pathways that I spoke about. For that specific purpose, we can pursue the strategy of withdrawing our applications and then evaluating the potential of refiling or we can pursue this strategy of appealing. And there are benefits and risks associated with either one of these strategies and currently we’re in the process of evaluating them. And soon as that evaluation is complete and our go-forward strategy is clarified we will make that known to the marketplace.

[Ren Benjamin:]

It seems like there is some precedence to the whole appeal process. I don’t know what the exact statistics are but I think just last year alone there were several drugs that had originally gotten a negative opinion, have then gone through the appeal process and then gotten a positive opinion and then subsequent approval in Europe. So hopefully that’s an option for you guys. Just switching gears very quickly to QS-21, it’s a program that’s pretty much on autopilot and you’re a little bit beholden to your partners, but more of a big picture question is, the whole development of adjuvants in general has been called a slug fest or slow going process. Is that just something that is particular to the adjuvant field? Is there something that is much harder with adjuvants than with other types of compounds and developments? And looking at something that’s been in the news lately regarding the flu vaccines and things surrounding H1N1 is there any sort of an interest or has anyone expressed any interest of evaluating QS-21 with any of those vaccines?

[Dr. Garo H. Armen:]

Certainly, let me address this separately just to clarify the point Ren about withdrawing followed by potential reapplication versus an appeal fulfill these strategies are going to be pursued in the spirit of keeping Oncophage alive for regulatory consideration in Europe. So we’re weighing the risk and benefit of each one of these strategies and rightfully you pointed out that our appeal precedence each one has a specific reason as to why they may have appealed. But a clear message I would like to convey here is that as of this moment, we are going to pursue potential pathways for registration of Oncophage inspite of disposition. So that’s one thing. In terms of adjuvants, let me take two issues separately. Adjuvant development has been as you said a slow process and our company like Glaxo Smith Klein would have put in a lot of effort historically in the development of optimal adjuvants and they are I think by all standards today the most advanced company in having fine tuned the optimal adjuvants based on today’s technology. And we're happy of course that QS-21 has been included in a number of their adjuvant formulations, which expands across a very significant proportion of their vaccine development program whether it is prophylactic vaccines or therapeutic vaccines. And if you talk off the record to any of their competition, you will find that the respect for GSK’s adjuvant portfolio is very very high and they are considered the most advanced in the world in this field. Evident by the fact that they have the most robust vaccine development pipeline, and once again we’re happy that our product is included in a great majority of those programs in clinical development. So I think adjuvants are absolutely critical for the activity of vaccines. And the field is coming to a point of maturity with these products as exemplified by the fact that we expect perhaps, the first product in the 2011-2012 timeframe followed by a significant of products beyond that. With regard to flu vaccines, whether or not to include QS-21 in there is not going to be an issue the swine flu vaccine has had to follow a very rapid timeline for delivery. In fact the regulatory authorities have accelerated this effort and lowered their regulatory hurdles for demonstrating the effectiveness of this vaccine. And we don’t know if the final vaccine will have any efficacy. We’re just basically doing it because of the level of panic out there because of the implications of not protecting at all. I’m not really privy to whether or not QS-21 has been considered for this, but suffice to say that QS-21 manufacturing for commercial scale application is not yet up and running. So it would take a little more while. If this was another year or so, perhaps QS-21 would have been considered because it makes vaccines very, very potent because of its attributes but I don’t any more information than that. So hopefully in GSK case and the larger manufacturing capability will be in place shortly.

[Ren Benjamin:]

I guess just circling back one last question on Oncophage. Clearly there are lot more countries that you could potentially be talking to and potentially pursue regulatory approval and Russia just being some of that out of the box thinking that you guys did. Are there any additional countries that you maybe looking at right now, that you are maybe be more advanced stages of discussion and could fall for regulatory approval?

[Dr. Garo H. Armen:]

All countries that we have been exploring and because of the level of effort that has gone into the European filing and subsequent follow up, we have and had the resources, internal resources, we are a small company as you know. We haven’t had the internal resources to really pay attention to other countries other than having some preliminary discussion either directly ourselves or through potential partners. So we will be evaluating those options also a bit more vigorously over the coming months.

[Operator:]

Your next question comes from Jeff - Vermont.

[Jeff:]

Over the last 18 months I have reviewed the material and it seems that I haven’t seen anything negative and I have been pleased with the progress. The question is, why hasn’t the EMEA seen at the same time?

[Dr. Garo H. Armen:]

Well, I don’t know what your expertise if you have any regulatory expertise I appreciate your comments. In the filing there is considerable details as to the products it's rational, the clinical information, its product attributes and so on and so forth. And one of the things that has come out which is a positive with the EMEA process is that there were considerably more question in the beginning of the process in the beginning of the review that as compared to how we ended up. So a number of very important issues have been addressed through this process, but a number have still remained open and I think given the timeframe, accelerated timeframe within which all of this has been considered, EMEA has done it's best to evaluate and make a determination. We would like to pursue this for reasons that relate to additional information that has come to light and some additional information that we expect to come to light over the next month. And that's one of the reasons we are evaluating the two separate options to see which is more advantageous for us from a timing perspective primarily and we'll have hopefully additional deliberations with the agency to see what the best way forward maybe. Having said that it is generally accepted by the agency and their outside advisors that guidance for approval of cancer vaccines are deficient and need to be revisited. They are deficient not because anybody has done wrong at the agency regarding these guidance, but because the agency hasn’t had to deal many applications in this field. And so we are to some extent, learning as we go along. And my hope and the company’s hope is that that learning process will get fine tuned as we continue our efforts.

[Jeff:]

So in your estimation, how long do you think the, depending upon the answer that this would slow us up on our approval process? And just to say is my guess is a year.

[Dr. Garo H. Armen:]

It’s too early to really make a determination for that. But once we get some clarification on what strategy we will pursue and get a better view of the specific processes and specific steps associated with that process, we will provide you better guidance on that.

[Jeff:]

I’m assuming you’ll have a conference call.

[Dr. Garo H. Armen:]

Either a conference call or press release, but certainly any interested party is always welcome to call the company and get additional clarity through our investor relations department.

[Jeff:]

And is the cash burn rate sufficient?

[Dr. Garo H. Armen:]

Well, I don’t know what sufficient really is per se, but we have provided financial guidance in terms of where our cash position, cash burn has been this year and we’re now going through our budgeting process for cash burn next year. Clearly our agenda is to try to contain cash burn as much as possible. We can't stop full of our efforts, but we will contain cash burn as much as prudently as possible, which we by the way if you follow our historical track record we've done a very good job at that over the last few years and continue to do. So we will contain cash burn while maintaining our capacity to be able to follow these programs to pursue these programs and try to stretch it as much as possible. So we certainly have enough cash to go through all of next year and then some and as we get through our budgeting process we'll provide you with better guidance in terms of exactly how much more than next year we'll be satisfied with our current cash position.

[Operator:]

Next your question comes from Brian Harris - Private Investor.

[Brian Harris:]

My question is, has the deal to EMEA and the vote, now there is 58, 50 some odd members there. Can you give us some flavor or color on how that vote went, I mean are we close in the vote or is it like weighed off or can you give us some clarification on that?

[Dr. Garo H. Armen:]

Okay, so just to clarify the number of votes are only 35 even though there are 58 members of the CHMP or 54 that are present from member countries, there are only 35 votes and some countries, there are 27 countries and 35 votes so you may wonder how that would work out. There are certain countries that have 2 votes, not because of their size or prominence, but because of the specific function that they’re involved in. So now, it is a fact that we don’t know by the way, how the voting went because the formal voting hasn’t taken place. What we have is an expression and we don’t know exactly how the split is. But the way European Agency works is by encouraging unanimous votes on everything. So I’m not aware of any voting that has gone on which has not been unanimous. So they basically try to get consensus on a decision. Whether or not there are dissenters doesn’t matter for reasons of protocol, the votes generally are unanimous.

[Brian Harris:]

So those votes are usually unanimous or can it be like one over, two over? Is it always unanimous?

[Dr. Garo H. Armen:]

I don’t know because these are not publicized. But what I have heard that especially in the last several years, all decisions tend to be made with unanimous votes. Even if there are dissenters the final vote tends to be unanimous.

[Brian Harris:]

Back on QS-21 and with Janssen Alzheimer’s Immunotherapeutic, the J&J division. Are we still in the 3 to 5% royalty range even though that contract was renegotiated?

[Dr. Garo Armen:]

Our royalty ranges with individual companies are a function of the type of product, the type of adjuvant mix used and the patent life of that adjuvant mix. So generally speaking our royalty range from 2% to 4.5% without being specific to what company or what have you. No royalties, no agreement that we've engaged in recent years starting by the way with the GSK, we negotiated agreement several years ago, which redefined the royalties to a higher level to a more certain higher level, nothing else has changed. So to answer your question directly will be absolute level of royalty related compensation to Antigenics would be the same as a result of this negotiated agreement with JANSSEN, the answer is yes.

[Brian Harris:]

Another question I was going to ask you is can you give me some flavor or color on how these royalty payments are broken down, I mean is the therapeutic vaccine worth more than say a prophylactic vaccine?

[Dr. Garo Armen:]

So, generally speaking, what I can give you guidance is that the product that we have discussed by and large are towards the high end of the royalty range. In other words products that we have discussed and highlighted which are Phase III programs tend to be under higher end of the range. Somehow the prophylactic vaccines that don't use extended patients life technology are towards the lower end of the range.

[Brian Harris:]

Another question I have getting back to the renal cell carcinoma study and your European approval, in past conference calls you have many times alluded and suggested that you are in partnerships talks. Can you give us some color on how that is going? I guess my comment is, in my opinion it would be prudent to me to get a partner somebody a big pharmaceutical, a deep pocket guy to help navigate the political and the regulatory nuances of the regulatory agency. And I was just curious if you can expand on that because it just seems like maybe going alone is a not in a long term health of the company when we have to continually go to the well with private placements and their warrants.

[Dr. Garo H. Armen:]

I agree with you entirely the fact that we don't have a deal yet, it's most likely not because we haven't made an effort but because of the novelty of the product, the novelty of the business model because it's an individualized product. We have pursued partnership talks unfortunately nothing substantiate has materialized just yet. We continue to have partnership talks although I would caution against anticipating a partnership that's going to $500 million or a large amount of money upfront that unlikely. The partners that we have been working with recently are local players that can help us in more than one way if you will not just financially but also to the loan efforts being driven by their own spending and we do have these underway right now in discussions. And some of these potential partners are spending their money already without even having the partnership agreement in place because of their faith into product and because of their belief that this product once we get the first break could be a very large potential for them and for us and could change the treatment paradigm for cancer. So there's interest but I cannot tell you that in the near term we're going to have something substantive where our burn rate will be affected by it very substantially that's one of the reasons we try to increase our run rate as much as possible to the prudent management of our expenses but I agree with it entirely. I mean there are other benefits of a partnership as well if we go to partner up with a large or prominent European player that has also political benefits with regard to the approval process.

[Brian Harris:]

So the parties you have been talking with had been more of the small regional companies not the big, Glaxos or Sanofis or Roche or what not -- they've been the smaller ones correct?

[Dr. Garo H. Armen:]

Lately, lately prior to the last year or nine months we have had talks with the larger partners as well.

[Brian Harris:]

Over the last, right now?

[Dr. Garo H. Armen:]

Prior to the last 9-to-12 months we've had discussion with larger partners.

[Brian Harris:]

Has the company learned anything or is there any light you can share on the meeting they had last Tuesday between the National Cancer Institute and the FDA on what direction they are going here with cancer vaccines. Is there been any light there?

[Dr. Garo H. Armen:]

Well, I mean we have learned a lot through our efforts with EMEA. We have learned a lot both in terms of the agencies issues, what they are concerned about the most. We have learned because we have interacted with a number of experts in Europe and got to know their more intimate believes and sentiments regarding Oncophage. All of that has been beneficial. We've also learned how to position the uniqueness of the product from a product perspective addressing a number of issues that are addressable with current science and technology so all of those things have been positive. With regard to the specific deliberations that you are talking about with the FDA other than more confusion, I don't know what really come out of it because most of these discussions are being driven by people that have driven the field for the last 20 to 25 years. So I don’t know how much they can add specifically to enlighten the regulatory agency on this issue. I think the field requires a leadership. I'm not sure if that leadership has yet stepped forward, but it definitely requires new leadership. We are working with organizations particularly in Europe and some in the U.S. as well who understand the scientific clinical and practical development challenges because if you do a trial in earlier stage patients, you're talking about a 6 to 10 year undertaking. If you look at the efforts by pharma companies in the field of cancer oncology drugs, I don’t know of any development program currently, I figure there is one somewhere, but I don’t know of any development program that targets adjuvant patients in oncology where you potentially could have the maximum benefit. In other words, essentially whole drug development programs are targeting metastatic disease. When things are too far gone provide benefit other than perhaps anywhere from two weeks to several months extension of life. If you want to have a more profound impact by preventing relapse in patients, that’s a very long undertaking and I don’t know of any major company who is working in this field. So the whole field needs to be revisited in terms of what to pursue, what types of patients to go after, what kind of clinical trials to undertake and how we get through the requirements of the regulatory system with these long juvenile trials to meet the expectations. So those are challenging issues and we haven’t been shy to tackle those challenges but we need to work collaboratively to get there.

[Brian Harris:]

With Russian Government, it's been since April of 2008, do we have like a timeframe you tell them to put up or shut up, tell them that we need a certain timeframe with which to execute on this or else drop the whole thing?

[Dr. Garo H. Armen:]

Firstly, I share your frustration with a couple of clarifications that I should point out. We have no right to tell anybody to put up or shut up because we need to respect the process that they follow in this regard and we do get frustrated at times but we still need to respect the process. Now typically in Europe, from the point of approval to the point of launching product having worked out reimbursement issues and so forth, typically is 12 months. If you are lucky, you can do it in about 9 months, but 12 months is about the norm some extend longer than that. So Russia is now at about 18 months, so it is longer than it would have taken in Europe partly because they’re new to this and we’re new to it. And at some point we’re going to pull back if we don't get any resolution but suffice it to say that our expenditures to pursue this in Russia are negligible. So we did the upfront expenses, we slowed it down very, very significantly. And going forward I would surprised to annualize if we spend more than a $100,000 to get to the next level. So we have chosen some very good people to work with, credible people, who understand our product and we’re hoping that we'll get a resolution but there’s no guarantee we will. But are we ready to throw in the towel right now? The answer is no only because it makes no sense to throw in the towel given how little we’re spending.

[Brian Harris:]

I should have used the less harsh phrase I guess so I apologize for that. But have the Russians given you any kind of timeline parameter or kind of a chain of sequences that need to fulfilled with which to execute on this or is it just kind of up in the air?

[Dr. Garo H. Armen:]

Well, as you know, one of the first hurdles that we had to overcome, which only we've overcome a few months ago was the export import license. So we are in the process of right now testing the export, import license from a practical perspective so that we have no glaciers in the system and I hope that that test will be completed in the next month. Now and that test basically involves a number of shipments back and forth to make sure that we're comfortable with it because it will be terribly embracing if we enroll out first patients and then something got hung up in the exportation office, we couldn’t export it in our out. So we want to make sure that that issue addressed before we can enroll patients. Is there a cure for patients even without government reimbursement, which we can execute, the answer is yes there are several patients who have been awaiting surgery to get the product, these are private pay patients. But without testing the export, import facility we will not enroll, or I shouldn’t say enroll because this is in a commercial setting. We will not get any patients from the commercial perspective. But at least by the end of the year we'll be in a better position having tested the import exportation pathway and perhaps having gotten a few patients commercially.

[Brian Harris:]

Do you know that the central government is allocating funds for Oncophage for the 2010 calendar year?

[Dr. Garo H. Armen:]

We have no notification of that but this is what we have been hoping to accomplish.

[Operator:]

Your next question comes from Joe Black - Private Investor.

[Joe Black:]

I’d like to kind of maybe work upon I guess if you could shed some light on, it's been about six months since I believe the last update. I know you had a conference in June, I guess relaying the infomration from the February or March RCC that timely or line of trials that are with the subset group. We've got another six months under our belt here. Are we still trending hopefully even better with the subset group, that being said and hoping for is it some of the additional information that has come to light here with either re-filing or going for the appeal?

[Dr. Garo H. Armen:]

We expect -- I have to be careful in terms of what we have disclosed publicly on this issue, but surfeited to say that if we had any negative signals we would be more discouraged in terms of moving the program forward, that's one. Secondly, I think we are due for an official look at the survival registry sometime around March or April of next year and at that point we will make the next data analysis public. So and I am hoping obviously that the trends will get stronger even.

[Joe Black:]

Okay. With that being said, okay, I am dealing with our folks over in Europe there, this time line for re-filing I guess is that's some information that would, I'm certainly guessing would come in the play on you making a decision. If you wait for the final results or again we're kind in the mid-term and I know you may or may not be able to answer that obviously but taking upon the fact that you just mentioned that there hasn’t been anything negative so one would assume its still positive based on that comment. That being said, the refiling, or the appeal added in the new information it appears to me like, I guess reading through a lot of text and all of this but the appeal process might be a little quicker than totally going for the re-file?

[Dr. Garo H. Armen:]

I think you are right. That’s why we are looking at the risks and benefit; the appeal process will be quicker although it may not be the best pathway because of the quickness of it. But I think as we get internal clarification on these timelines, we would be happy to share them with you. There are a number of issues. It's not just a mixture of data coming out of the survival registry. But there are bunch of other things that need to be attended to and addressed for us to optimize the probabilities of success. So bear with us and as we go through this analysis and get clarity, we will share that with you.

[Joe Black:]

The trials going on with Temodar and I don’t know if I pronounced that right. A little research I guess, I did on that and again certainly my PEG rate doesn’t allow me to be any kind of a oncologist here but in laymen's terms adding that with Oncophage here I know we are looking obviously for all kinds of positive things. But as of my understanding that is kind of a pill form that is given to patients after they've had surgery removal and helping with the, I guess non recurrence?

[Dr. Garo H. Armen:]

Temodar has become sort of a standard in this patient population that's why the trial is Oncophage plus Temodar and in terms of, does it prevent recurrence, the answer is no, it doesn't. It seems to delay or extend survival a bit so it's not something that really changes the course of the disease in any meaningful way and the question is if we combine it with Oncophage could we do better.

[Joe Black:]

Okay, is QS-21 be involved with that also?

[Dr. Garo H. Armen:]

No not in that.

[Joe Black:]

I believe there was I wondered two new positions that you guys were looking for internally are those, again I didn't understand them at all okay but in laymen's terms here I guess. Is this to help us to go forward with any (inaudible) questions or any other approvals with glioma or what the dose, are those new positions are they replacement positions I guess?

[Dr. Garo H. Armen:]

We have, I mean there is a natural attrition with our company that occurs, people leave from time to time and sometimes we restructure position, sometimes we let people go based on performance issues. Although we are down to a pretty core team now and the competent level of our professionals at the company is extremely high. So I do not expect any performance related attritions on a massive scale or anything like that. The headcount has gone down steadily and any positions there we add on from time to time are mostly as a result of replacements for people that leave or some restructured positions where we change the responsibilities and bring in other people to fulfill them.

[Operator:]

There are no further questions. Ms. Shalini will have the closing remark.

[Shalini Sharp:]

I would like to remind listeners that replay of this call will be available approximately two hours from now through midnight Eastern time on November 12, 2009. Please dial 1800-642-1687 from the U.S or use the international number, which is 706-645-9291. The access code is 37318218 and the replay will also be available on our company website in approximately two hours. If you have any additional questions after today's call please call us at 1800-962-AGEN or 2436 thank you.

[Operator:]

This does concludes today's conference call you may now disconnect.