Agenus Inc (AGEN) 2005 Q3 法說會逐字稿

Good morning. My name is April, and I will be your conference facilitator. At this time, I would like to welcome everyone to the Antigenics reports third-quarter 2005 financial results and recent highlights 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. I would now like to turn the conference over to Ms. Shalini Sharp. Please go ahead, ma'am.

Thank you, April, and good morning everyone. Welcome to Antigenics' conference call to discuss our corporate and an clinical progress, as well as our financial results for the third quarter ended September 30th, 2005.

With me today are Dr. Garo Armand, Chairman and CEO, Peter Thornton, SVP and CFO, and Dr. Renu Gupta, SVP of Development. We hope that all of you have had a chance to review the press release that was issued this morning. We will review the financial results as well as operational highlights from the third quarter, and then take any questions you might have for Garo or Peter.

But before I turn the call over to senior management, I would like to remind you that during this conference call, Antigenics' representatives may make forward-looking statements including statements regarding Antigenics' potential commercial of Oncophage; the timing and final analysis of the data from the Phase 3 trials in melanoma and renal cell carcinoma; plans to commence new trials; expectations that trials will support regulatory filings and projected enrollment in those trials. These forward-looking statements are subject to risk and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, timing of events in the renal cell carcinoma trial, the results of clinical trials, the cost of additional clinical trials, the ability to raise additional capital, and the factors described under "Factors That May Impact Future Results" in the Management's Discussion and Analysis of Financial Condition and Results of Operations section of Antigenics' Form 10-Q as filed with the Securities and Exchange Commission on August 9, 2005. Antigenics cautions investors not to place considerable reliance on the forward-looking statements made during this conference call. These statements speak only as of the date of this call, and Antigenics undertakes no obligation to update or revise the statements. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Antigenics' business is subject to substantial risks and uncertainties, including those just identified. When evaluating Antigenics' business and securities, investors should give careful consideration to these risks and uncertainties.

I will now turn the call over to Peter Thornton, who will review the financial results for the past quarter.

Thank you, Shalini, and good morning to everyone. I will now review our financial results for the quarter ended September 30, 2005.

For the third quarter of 2005, Antigenics incurred a net loss attributable to common stockholders of 17.5 million, or $0.38 per share, basic and diluted. This is compared with a net loss attributable to common stockholders of 18.7 million or $0.41 per share basic and diluted for the same period in 2004. The prior-year net loss includes the charge of 2.9 million related to acquired in-process R&D that was primarily a non-cash charge and was related to the acquisition of Mojave intellectual property during 2004.

The operating loss for the quarter reflects continuing investments and progress on the development of our pipeline, particularly Oncophage, but also product candidates such as Aroplatin in oncology, and AG-707 for genital herpes in the area of (ph) infectious diseases. Both of these opportunities address significant potential markets for Antigenics.

When comparing the third quarter of 2005 to the second quarter of this year, our operating loss has decreased from $21.1 million to 17.2 million, a reduction of approximately $4 million. This is in line with our expectations, as indicated on our last quarterly call, and includes the beneficial impact of prioritization cost savings noted last quarter.

Turning to the income statements, revenues for the quarter are comprised primarily of shipments of QS-21 to our QS-21 licensees. Revenues amounted to $77,000 in the three months ended September 30, 2005 as compared to $282,000 for the same period in 2004.

Looking at operating expenses, total research and development expense for the quarter was approximately $12 million compared with 9.8 million in the same period in 2004. This increase was driven by a high level of activity and progress on our development programs, and includes higher employee and related costs incurred on these programs; startup costs related to our Oncophage renal cell carcinoma part 2 Phase III trial; and the preparation of filing of 2 INDs. These are offset by lower clinical site payments on our melanoma and part one RCC Phase III trial as they near completion.

Total general and administrative expenses for the third quarter were $5.2 million compared with $6.3 million for the same period in 2004. This reduction of approximately $1 million was primarily driven by a certain onetime costs in the prior year and our continuing efforts to manage costs appropriately.

Turning to the balance sheet, cash, cash equivalents and short-term investments amounted to 77.2 million at September 30, 2005, as compared to 96.6 million at June 30, 2005. Given our current cash position and anticipated burn rates, we believe we have sufficient cash to fund our operations into mid to late 2006, and we will continue to carefully manage our available resources.

This concludes the financial portion of the call. And I will now turn it over to Garo to continue.

Thank you, Peter, and thank you all for joining us this morning. I would like to take this opportunity to provide an update on recent events.

Let me start by saying that I realize some in the investment community are skeptical of our technology. As it is a new class of therapy, this is understandable. But our platform technology is unusually well validated for such a new approach which has been independently documented extensively, I must add, not only by Antigenics, but also by dozens of independent laboratories around the world. Out of respect for your time and for the purposes of providing optimal transparency, we have had these publications, as well as summaries to most of these relevant publications, referenced on our website, which is www.Antigenics.com.

In addition to the significant scientific and preclinical work supporting the rationale for our technology to treat cancer, we have shown signs of activity in six difficult cancer indications in human clinical trials. Recently, we announced data from our first large randomized human clinical trial, in which we showed a meaningful survival improvement in better prognosis metastatic melanoma patients. Next year, building on these results, we will see data from our 700-plus patient trial in renal cell carcinoma, which is even larger and was conducted entirely in a better prognosis patient population. We're obviously eagerly waiting these results.

Let me now start by reviewing our 322 patients randomized Phase III trial in stage IV melanoma patients. This represents the first time ever data was analyzed and disclosed from a randomized trial testing Oncophage. All of our previous experience with Oncophage were in the form of single-arm trials in which we collected data on tumor responses, immunological responses, and survival or disease-free survival as compared to historical controls. The preliminary data from our first randomized trial show stage IV melanoma patients of a prospectively defined subset who received Oncophage survived considerably longer than those who received a robust regiment of biochemotherapy and/or surgery. This conclusion is based on an intensive treatment analysis. While these results are not statistically significant due mainly to the smaller number of patients in the M1A group, they demonstrate a very large benefit for patients treated with Oncophage as compared to the reference arm.

I would like to highlight some additional stats on our melanoma trial. And let me start by -- number one, the trial protocol defined the subgroups of patients to be analyzed as M1A, M1B, and M1C prospectively. Any reporting to the contrary is not accurate. These subgroups are defined by clinicians and are widely used.

Number two, the reference arm we used in the trial has been declared by melanoma experts as a very high standard. And some have declared it as the highest standard we could test Oncophage against. The reference arm was the physician's choice, meaning that the physician could prescribe any treatment that he or she wanted within a minimum criteria that was defined in the trial. The physician could be very aggressive in treating the patient in the control arm as he or she deemed it.

Three, when we look at established prognostic indicators, such as complete resection of the tumor and ECoG scores, the Oncophage arm and the physician's choice arm are well balanced. Any small imbalances that exist with regard to both of these criteria are actually imbalances that represents biases against the Oncophage arm. These small imbalances were previously reported incorrectly by some as favoring the Oncophage arm. And that is not correct.

Number four -- the time for first treatment was considerably longer in the Oncophage arm versus the physician's choice arm -- on average, more than four times as long, representing another potential bias against the Oncophage arm.

Number five, some reports indicated that partial resections can also be a positive prognostic factor for M1A and other stage IV melanoma patients. The facts are that the overwhelming consensus by the melanoma community indicates partial resections do not have any bearing on survival whatsoever. And therefore, partial resections are only performed for palliative reasons. Therefore, the reported claims to the contrary are not true.

Number six, and lastly, we had declared that this melanoma trial would be not a registrational trial for reasons which are well known and well discussed extensively in every filing made by Antigenics, including our 10-K and the last four 10-Qs, as well as our S-3 filings. These data -- and actually, a lot more data from this trial -- are going to be written up for a major peer-reviewed article, as well as for presentation at ASCO 2006. Those considerations limit our ability to say more about the data and provide you more detail at this time.

Thus, the results of our Phase III trial represent a positive outcome which exceeded our expectations. This outcome further validates our scientific principles, as well as our very extensive preclinical data. While M1A patients represent a relatively small total target, these results represent an important proof of principal which brings us closer to the validation of our platform technology and our product, Oncophage.

Let us now spend a few minutes on reviewing these results. The results from our randomized melanoma Phase III trial demonstrate that, in patients with M1A, median survival improves from 12.8 months in patients treated with physicians' choice to 20.9 months in patients treated with Oncophage. This difference clearly represents a significant clinical improvement for stage IV M1A patients in whom no drug has been reported to have shown any survival benefit so far.

As a clarifier, stage IV melanoma is a deadly disease with a dismal five-year survival rate of less than 5%. Yes, these results are not statistically significant due to the smaller sample size. However, the Kaplan-Meyers survival curves separate and clearly stay separated after approximately 11 months of medium follow-up which represents a relatively long period in the lifespan of these patients and the patients in the two arms who are well-balanced for the relevant prognostic factors -- I hope these facts -- I have provided additional clarification on the matter of our recently announced data.

The encouraging results from our melanoma trial provide a strong foundation for the development of Oncophage going forward. Most notably, I will discuss our Phase III programs in adjuvant renal cell carcinoma, our (ph) kidney cancer. Part one of our Phase III trial in adjuvant renal cell carcinoma completed enrollment in September of 2004. This is an international multicancer (ph) trial comparing treatment with Oncophage to observation in a 1 to 1 ratio of randomization.

This is an event-driven trial, which means that we are waiting for a certain number of recurrences to occur before we can conduct our final analysis. The pace of events in this trial remains lower than our original estimate. And our expectation remains that we will initiate a final analysis during the first half of 2006.

Antigenics is accelerating all aspects of the trial that are under our control. We have put into place procedures that may enable us to complete our analysis quickly once the final events are obtained.

If this data sufficiently passes (ph) positive, we plan to discuss the data with the authorities for filing for in the U.S. and Canada, and in Europe. Depending on the outcome of these discussions with the health authorities in the U.S., Canada, and Europe, we hope to submit for approval in Canada and Europe as well as the U.S.

As you know, and as the FDA has indicated and disclosed in our public filings, this trial alone as indicated by the agency will not be sufficient for product registration, as our potency assays were not in place when we began this trial. However, if the results of our trial are positive, we plan to approach the agency seeking for permission to file for approval.

There are several reasons why we feel that this could be a viable strategy. Particularly under the accelerated approval process, the FDA has in the past approved cancer therapies on the basis of much smaller single-arm trials when significant efficacy was demonstrated. Our trial is the largest single-arm randomized trial to date in this patient population, and is designed to show statistically and clinically significant patient benefit. Oncophage appears to have a favorable safety profile, particularly in comparison with other cancer therapies, and this patient population has no postsurgical treatment options available.

As you know, we retained samples of product batches manufactured for our Phase III trial prior to the implementation of our potency assays so that we could retrospectively test them. Now that our assays have had been fully validated, we have completed retrospective positive testing on these batches. We will be submitting a report to the agency to substantiate product potency in this trial.

In parallel with these activities, we have begun actively dosing patients in part two of our Phase III renal cell carcinoma trial. This trial will be similar -- it is similar in design to part one, and will enroll approximately 600 patients. Depending on the outcome of part one, it is possible that the design of part two will have to be amended. Incidentally, to date, we have spent less than 45 million on part one of our Phase III RCC trial and our Phase III metastatic melanoma trial. We estimate that the total combined cost of part two of our RCC trial and new Phase III melanoma trial will be in the range of 40 to $50 million as well.

Oncophage is also under investigation in metastatic renal cell carcinoma and non-small cell lung cancer. We are expanding our Phase II metastatic renal cell carcinoma trial and have completed enrollment in our Phase II lung cancer trial.

Let me now move on to the remainder of our pipeline. AG-707 is our heat shock protein based therapeutic vaccines designed to activate the immune system to targets HSV-2 infection. AG-707 consists of recombinant human heat shock protein complex with 32 synthetic peptides representative of functionality and structurally relevant sequences of the herpes simplex virus type 2, or HSV-2, proteins.

HSV-2 is the primary cause of genital herpes, which currently afflicts approximately one in five Americans age 12 and over. The National Institutes of Health currently recommends preapproved products for genital herpes which have combined annual worldwide sales in excess of 2.5 billion. We recently began a Phase I trial with AG-707. The trial will enroll up to 84 patients infected with HSV-2 who have a documented history of clinically active genital herpes. The study will evaluate the safety profile and immunogenicity of AG-707 with and without a proprietary adjuvant at predose levels compared to placebo or adjuvant alone. AG-707 is an off-the-shelf product, not a personalized medicine like Oncophage.

Aroplatin is our novel third-generation liposomal encapsulated platinum compound in development for the treatment of cancer. It is designed to reduce certain types of toxicities typically associated with other platinum agents, as well as to overcome drug resistance. Aroplatin is similar to Eloxatin sold by Sanofi Aventis, which has global sales of approximately 1.5 billion in 2004.

Antigenics recently announced initiation of a Phase I trial in solid tumors and B-cell lymphoma with Aroplatin, which has been reformulated for improved drug activation and stability. The primary objective of this multicancer study are to establish the maximum tolerated dose and determine the pharmacokinetics and safety profile of the product. The trial is expected to enroll up to 28 patients.

Our autologous cancer vaccine for liquid tumors AG-858 is similar to Oncophage in terms of mechanism of action. AG-858 is in Phase II trials in chronic myelogenous leukemia, or CML, in Gleevec-refractory patients. We have expanded enrollment in this trial, and we will be evaluating extended dosing with AG-858.

We also continue to drive progress in our earliest stage programs, including next generation Oncophage and autoimmunity, among others. We're very pleased with the progress the Company has made this quarter, particularly with regard to our clinical stage pipeline, and we look forward to bringing these programs to fruition in the near future.

This concludes my formal remarks. And I believe that now we're ready to take questions for our management team.

(OPERATOR INSTRUCTIONS). Mark Monane, Needham & Co.

Could we please have some more information on the products other than Oncophage? Could you help us understand how Antigenics is managing the pipeline beyond the Phase III products, especially with reflection on the CML vaccine, as well as the new formulation of Aroplatin in terms of upcoming milestones.

Okay, Mark, what we're trying to do with these products -- obviously, one of the criticisms of the Company has been that we have a lot of products on our plate, and will we be able to successfully bring some of these programs to fruition? And clearly, I sense that your question is targeting partly that.

And clearly, that is an active issue of consideration by us. And what we are doing is to get these products to a point where we can demonstrate proof of principal that are widely accepted by the pharmaceutical and the biotechnology industries, and then at that point, further explore options on which products will be pursued by Antigenics based on our resource requirements, and which products should be licensed or partnered with other parties, as well as how some of these programs should be financed by vehicles that are available to us outside of the typical equity financing available to the Company.

So we are actively considering entertaining those options while we are also aggressively moving these products to a point of demonstrating proof of principal so that we can maximize the value of these products, regardless of which option we shall pursue.

That makes sense. Can you help us a little bit more in thinking about the timeline of these pursuits? For example, the data on 707 -- can you give us an estimate of when you think you'll have enough information to make those kinds of decisions?

Okay, so it will be partly contingent upon how quickly we enroll in these trials, which, given that we just started, is not known to us yet. But the hope is that given the endpoints we are looking for, if we can enroll, let's say for argument's sake, in six to nine months, and then take another six to nine months for evaluation, we will be in a position of at least having some of the measurable outcomes available to us within a 12- to 18-month period.

That's helpful. (multiple speakers) And the last question on 858, which looks like it could be very exciting, what was the Company's goal in adding more patients at this point?

Okay, let me articulate without disclosing too much data, because we would like to have the right, again, to present the data. Based on our findings from the treatment on earlier patients, we modified the trial structure so that some hints of activity could be further validated by this modification in the trial structure.

In addition to that, when we started this trial, as you remember, there were some uncertainties as to the integrity of the incoming material for us to make the vaccine from. We further modified the procedures that are to be followed in the field for the collection of blood samples so that we can standardize the incoming material to be more certain of the outcome of the integrity of the product made from it. Renu, would you like to add anything to those comments?

Good morning, Mark. As Garo said, our goal is to study longer administration of the vaccines, and to follow patients longer to assess durability of response in these patients who are essentially refractory to Gleevec.

Ren Benjamin, Rodman & Renshaw.

Congratulations on your ongoing progress. A couple of quick questions. The first one is regarding the ongoing Phase III renal cell trial. Garo, I know in the past that you have updated us regarding how many events have taken place. Can you refresh our memory as to how many events you need to take place in order for the unblinding to occur, as well as how many events have already taken place?

So let me just do it without violating any of the confidentiality of the trial. I think it has been in the public domain that approximately 220 clean events are needed to trigger the final analysis. However, one concept has been very difficult to appreciate. And I empathize with it, because until we got into the nitty-gritty of this trial, it was also not simple for me to understand. So that's why I empathize with this personally.

Now, given that this trial -- the end analysis or the final analysis is to be figured by the number of recurrences, which is something that's defined in our protocol -- in other words, we cannot fudge and say, well, if the protocol says that the final analysis is triggered by 220 events, okay, we cannot say we're going to do that at 200 events. If we do, we would jeopardize the statistical analysis and the integrity of the trial.

So given that, then the question becomes, well, when do you get to 220 events? And then we have been somewhat unclear -- or perhaps we have been clear, but the issues are again difficult to understand, because if it were simple and if the events were clearly defined, then we would be able to provide a lot more clarity to the situation.

However, these events need to be verified because if a clinical center reports an event, for FDA purposes, that event cannot be registered as an event until an independent review body, consisted of three radiologists and an adjudicating oncologist, agrees or disagrees with that assessment. So we are currently going through that process. And until we have at least a significant sample size reviewed by those independent members, we will not know exactly where we are.

Suffice it to say that we have made some assumptions in the trial. And we have made assumptions of certain cuts. And we are using those cuts based on these assumptions to indicate that we will be at a point of final analysis in the first half of 2006.

Now, I must tell you that once a significant sample size has been reviewed by the independent radiologists and the adjudicating oncologists, we will then be able to better assess what that cut is. And then we will come to you at that point and provide you with a much more specific guidance. We anticipate that we will be there sometime in the -- what, November, December timeframe in terms of the significant number of events having been reviewed?

Right. We should have further assessment by the independent review committee that Garo alluded to earlier sometime later this year in order to project when we would expect to trigger a final analysis. Our current estimates are early next year that we should be in that position.

Yes. In the way of comparison, if the endpoint or the primary endpoint in the trial was death, for example, we wouldn't need this independent review, because very few people think that there's any ambiguity at all about what is death and what is not. But there is an element of ambiguity about what is a recurrence and what is not.

Okay, great. Fair enough. Can you talk to us a little bit about the metastatic RCC trial? You said that you have expanded it. Why did you do the expansion, and how much are you expanding enrollment to? And when do you think we can have data from that trial?

That study is enrolling only at one center. And the plan is to expand the numbers of centers. The total target number of patients is still the same. And we are encouraged by the data. And we're planning to submit an abstract for ASCO this year.

ASCO this year -- (multiple speakers) 2006.

That's correct; we're planning to submit in January.

Okay. Regarding the non-small cell lung cancer trial, you said enrollment is complete. Can you give us an idea as to how long you think follow-up will take, and when we might see data from that trial.

That is an adjuvant therapy trial in non-small cell lung cancer. And essentially we have to wait for recurrence of disease. We are estimating that we will have some data mid to late next year on recurrences. It's a small study. The primary endpoint was safety in feasibility. But we are monitoring patients for recurrence as well as survival.

Okay, great. And then just my final question -- regarding events that are coming up or presentations at meetings, can you just review for us very quickly any presentations that might be coming up, either at the ACR or ASH --?

Certainly at ASH, the C-300-01 study that Garo was referring to earlier -- there is an abstract which has been accepted for a poster presentations. And data will be presented by Dr. David Marin (ph) from the UK.

And we unfortunately do not have an ACR this year. But we will be submitting abstract for ASCO next year. And we're planning on submitting publications from our renal cell carcinoma trials in the metastatic disease setting, which were conducted in the Phase I/II setting. There is a review article that has also been accepted, but I'm not at liberty to disclose that, because we are in the galley proof review at the present time.

Jonathan Gray, Sanford C. Bernstein & Co.

Yes, my understanding is that historically, the expectation was that immunotherapy such as a vaccine which sought to boost immune response through an autologous vaccine like your own -- that it was incompatible with chemotherapies -- chemotherapeutic drugs which acted by killing cells that divided rapidly.

However, I believe if I'm not mistaken -- perhaps you could confirm this, Garo -- there seem to be a number of research pieces out that suggests that some immunotherapies, some vaccines are not found to be in conflict with chemotherapy, but in fact have a synergistic impact because the chemotherapy in killing tumor sales supplies the immune system with so much available antigen. If this is the case, doesn't it suggest a vast expansion of the potential commercial market for the Oncophage and similar products?

Thank you, Jonathan. I think your assessment is absolutely correct. And that's one of the reasons this year we undertook testing that principle in preclinical models. We are somewhat driven by our preclinical models because we have always -- for certain that when it comes to immunotherapy and cancer models, mice tell us a lot more than perhaps when you're trying to study a metabolic drug.

And so we have evidence now that what you say is true, at least for the drugs that we have experience with. We have tested at least one chemotherapy agents at somewhat lower doses than this agent would be used typically in a human, real-life situation -- and demonstrated that the combination of Oncophage or Oncophage used in accordance to the protocol in combination with this particular chemotherapy agents, does show improved efficacy -- and it's notably improved, and these experiments have been repeated -- versus Oncophage alone or the chemotherapy alone in the equivalent of late-stage patients.

So that's been a very encouraging driver for our further strategy of taking this concept into the clinic. As you may know, we are taking Oncophage plus ATRA-IV into the clinic. That will happen near-term. And all of the work on that preclinical work has been completed, and that notion has been confirmed with regard to ATRA-IV. Even though ATRA-IV is not a typical chemotherapy agents, it is an agent that's compatible from the perspective of mechanism of action of what we're trying to accomplish by stimulating the immune system.

And sure, if we do find that the activity of immunotherapy is enhanced by some of the traditional chemotherapeutic drugs, then we will find of course that the potential market will be considerably larger for us.

Is there any plan or possibility that the Company might have available to it along with ATRA-IV some kind of small molecule or monoclonal antibody that would be designed to reduce tolerogenesis (ph)?

Yes. That is too -- is an active program. In fact, we have done some preclinical experiments in that regard as well with encouraging results. And as you know, the potential product candidates are not currently available commercially. So we find ourselves in the predicament of the short supply of some of these products that make it difficult for us to start clinical trials tomorrow, perhaps. But we are eager to pursue that program.

Let me just offer my personal congratulations and good wishes.

(OPERATOR INSTRUCTIONS). Greg Zolie (ph), National Securities.

I have a couple of questions. One, you've already touched on -- there's some ambiguity on the clarity of the melanoma data that came out on the 17th. And I think that you were pretty clear on how you felt about that. But on the release of that data, have you come up on the radar screen or had any conversations with potential partners or people interested in that data?

Greg, we have an active business development effort, and have had it for now at least a couple of years. We have had numerous discussions with many of the major pharmaceutical companies -- many of them, and also a number of our biotechnology companies -- larger biotechnology companies. These discussions continue. And would, for example, under normal circumstances additional data trigger an interest to sit down and discuss it typically with these partners or even newer partners? The answer is yes. That would normally happen, and there's no reason to expect it to be different in this particular case.

Okay. And a third question, I'm sure you may or may not have the answer for this, but you have had a lot of data come out, a lot of reasons to be excited. And you'd think it would be reflected in the stock, but the short interest in the stock over the last 30 days has gone up over 1 million shares. Do you have any explanation for back?

No, I don't. I mean, we can theorize about it. We have been on the -- I guess, SHO list (multiple speakers) for quite some time.

Exactly. That's why it's interesting that your short position went up so much.

When people ask me about what is SHO, I don't really know, because I'm not really skilled in these things. But from some of the analogies that I have been at least told, is selling stock naked, or naked short, is analogous to somebody walking around Manhattan and pointing to buildings that they may not own and selling them.

And so from a regulatory perspective, while we and everybody else associated with us believe in free market economics, we also believe in an orderly free market economic environment.

So I think these issues need to be considered by authorities very carefully. And I'm not privy to all of their consideration in this regard. But as you pointed out, we do have a very high short interest. In fact, our short interest went up by 1 million shares since the announcement of the melanoma data. Since we are already hard to borrow and on the SHO list, I would imagine that that incremental shorting has been done through the naked shorting process. And I wouldn't venture to guess as to what the motive of the individuals or the companies who engage in these practices are. But I will leave it at that.

Jonathan Gray, Sanford C. Bernstein & Co.

I'd like to pose two questions, neither of which I would want you to waste time on unless you feel they are productive. The first would be whether the regulatory environment or lack thereof in offshore, overseas in countries like India or China or Israel or Germany or wherever provides either an opportunity or a risk for developing biotechnology firms such as your own. And -- well, let me -- what was my second question? I've forgotten my second questions. (laughter)

It's okay, Jonathan. I think -- you know, we are engaged in clinical development globally, including we have patient recruitment going on right now in India, or we will have it shortly in India as part of a trial that's a U.S. trial. It will enroll patients in a site in India as well. And we're doing this in other countries as appropriate.

Now, the question is one of -- do we do this to expedite patients enrollment, and/or to get patients in some of these countries that would otherwise not be available to us in the U.S. because of the standard of care in the U.S. or other considerations? And the answer is yes to all of these questions. We would consider enrolling patients in other countries. We're doing it also in Latin America, for example -- part two trial in renal cell carcinoma is currently enrolling patience, or will be enrolling patience in Latin America. And Latin America has a sizable renal cell carcinoma population.

However, if I read you correctly, the second part of that question may be would we consider more expeditious development of our programs in other countries? And the answer is, to the extent that we can do this appropriately with the consent and the appropriate reporting requirements that are mandated upon us by U.S. authorities and others, yes, of course we would do that. And that's one of the reasons, for example, we have gone to Canada and we explore opportunities elsewhere.

But what we don't want to do is bypass any rule and regulation that is imposed upon us by the FDA with regard to any of these activities, because we are a U.S. company. And our primary driver is to ultimately gain approval sooner, hopefully, rather than later in the U.S. And so that's why we will be very much driven by the guidelines provided by the FDA in all of our activities.

At this time, there are no further questions. Ms. Sharp, are there any closing remarks?

Yes, thank you. To close the call, a replay will be available approximately two hours from now through midnight Eastern time on November 10, 2005. Please dial 800-642-1687 from the U.S. or use the international number which is 706-645-9291. The access code is 160-4545. The replay will also be available on our Company website in approximately two hours. If you have additional questions after today's call, please call us at 800-962-AGEN, or 2436. Thank you.

This conclude today's conference call. You may now disconnect.