Agenus Inc (AGEN) 2005 Q1 法說會逐字稿

Good morning. My name is Marcus and I will be your conference facilitator today. At this time, I would like to welcome everyone to the Antigenics Q1 Results and Recent Highlights conference call. [Operator Instructions] I would now like to introduce Mr. Jack Howarth, Head of Investor Relations. Sir, you may begin your conference.

Thank you, Marcus, and good morning, everyone. Welcome to Antigenics’ conference call to discuss our corporate and clinical progress, as well as our financial results for the first quarter ended March 31, 2005.

With me today is Dr. Garo Armen, Chairman and CEO of Antigenics, Peter Thornton, CFO, and Dr. Renu Gupta, SVP of Development.

We hope 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 the recent highlights from the past quarter and then open the lines up for any questions you might have for Garo, Peter, or Renu.

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 the timing for, and results of, final analysis of Part 1 of our Phase III renal cell carcinoma trial; potential filings with regulatory agencies; potential commercialization of Oncophage; the final analysis of our melanoma trial; the filing of an amended IND for Aroplatin and initiation of a new clinical study for the compound; and the time for filing an IND for AG-707.

These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among other things, the results from ongoing Phase III clinical trials; the need for and extent of additional clinical trials; the decisions by regulatory agencies; timing and results of preclinical studies; and the factors described in our Form 10-K, as filed with the SEC on March 31, 2005.

Antigenics cautions investors not to place considerable reliance on the forward-looking statements made on this call. These statements speak only as of the date of this call, and Antigenics undertakes no obligation to update or revise these statements. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Antigenics’ business is subject to substantial risks and uncertainties. When evaluating our business and securities, investors should give careful consideration to those risks and uncertainties

I will now turn the call over to Peter Thornton, who will review the financial results for the past quarter, followed by Dr. Armen, who will discuss recent highlights as well as upcoming milestone. Finally, we’ll open the call for your questions.

I’ll now turn the call over to Peter.

Thank you, Jack, and good morning to everyone. I will now review our financial results for the quarter ended March 31, 2005.

For the first quarter of 2005, Antigenics incurred a net loss attributable to common stockholders of $18.2 million, or $0.40 per share. This is compared with a net loss attributable to common stockholders of $17.4 million or $0.41 per share for the same period in 2004.

The increased loss of approximately 5.0% is primarily due to continued progress on the Company’s clinical development programs, global regulatory filing activities and costs associated with preparing for commercialization of Oncophage.

Revenues for the quarter are comprised solely of the sale and supply of QS-21, our vaccine rejuvenate product. Revenues amounted to $120,000 for the 3 months ended March 31, 2005, as compared to $110,000 for the same period in 2004. During the quarter, as previously disclosed, we entered into a new license agreement for QS-21 with Pharmexa of Denmark.

Turning to operating expenses, total R&D expense for the quarter ended March 31, 2005 was $11.3 million, compared with $10.9 million for the same period in 2004. This increase represents higher staff costs as we prepare for BLA filing activities, offset by lower Phase III trial costs primarily reflecting the completion of enrollment in our two Phase III trials during 2004.

Total commercial G&A expenses for the first quarter were $6.8 million, compared with $5.5 million for the same period in 2004. The increase was primarily due to costs associated with preparing for commercialization of Oncophage.

Turning to the balance sheet, cash, cash equivalents, and short-term investments amounted to $114 million at March 31, 2005, as compared to $87 million at December 31, 2004.

As you may recall, this past January we completed a private placement to third party investors of 5.25% convertible senior notes due in 2025, resulting in net proceeds to Antigenics of approximately $48 million. The notes are convertible into Antigenics’ common stock at a price per share of $10.76. Given our current cash position and anticipated burn rate, we believe that we will have sufficient cash to fund our operations into 2006.

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

Thank you, Peter. It has been a little more than 2 months since our last call, so this morning I will update everyone on the progress of our clinical programs, as well as other internal projects we have been working on.

The first item is I wanted to touch on the subject that we have had lots of questions and some confusion and it concerns the product characterization issue. Since our product was put on clinical hold and since the clinical hold was lifted, our product characterization questions have come up from time to time.

As you know, as part of our ongoing commitment to the FDA, we have been actively working with the agency to resolve all outstanding product characterization issues related to Oncophage, which are appropriate for this late stage of development. As part of these activities, in September 2004 we provided the agency with documentation to support the analytical validations of two potency tests.

Since this time, the agency has reviewed the documentation, engaged Antigenics in discussions around its work, and have recently communicated that the potency validations are acceptable for the release of Oncophage for clinical investigation.

Based on discussions with the agency over the past 6 months and based on the most recent communication, we feel confident that all product-related characterization issues have been successfully resolved at this point in the development of Oncophage.

Regarding progress with the timing of the data analysis from our Phase III renal cell carcinoma (RCC) trial, as you all know, we have been waiting for the number of events required to trigger the final analysis for this trial. Based on the recent monthly trend for events, we expect the final analysis to be triggered in the August-September time frame.

These events are somewhat out of our control, as you know, and it appears that they have slowed down a bit and therefore the slight delay of a few months in the timing. We have put into place key processes and procedures, such that within 6 weeks of the trigger for the final analysis we will be able to clean up the data and appropriately make any public disclosures regarding the results thereafter.

While waiting for the data, we have been busily preparing for our global electronic filing should the results of this trial warrant registration of our product in the geographies where we have conducted the trials. These include the U.S., Canada, and Europe. In this regard, we’ve had discussions with the agencies involved.

Our ability to file will be a function of, clearly, foremost the data demonstrating benefit to patients, as well as concurrence by these agencies as to our registrational strategy, a key part of which is the acceptance of our product, which was administered to patients in our ICC trials, [as being] sufficiently characterized.

As you know, from our previous disclosures, that the U.S. FDA has indicated to us that this trial alone will not be sufficient for product registration due to these technical reasons of not having our potency testing done before patients were treated with Oncophage.

We plan on making data available to the FDA with the aim that we will be able to overcome these issues before a BLA filing is made. Additionally, testing of patient product samples for potency are now well underway and we feel confident that we will have all the data on this in the near-term.

While all these activities are ongoing, we have started our second trial with all the product characterization issues having been addressed with the agency formally. This will be a 600-patient randomized trial; very similar in design and structure to our first 800-patient randomized trial for RCC. However, should the results from our first trial be positive, there is a possibility that, with the consent of the FDA, the trial design may be modified for ethical considerations.

Now, switching to melanoma, data from our Phase III trial continues to mature. We expect the last events from this 300-plus-patient trial to occur in the second half of the year and data analysis should be completed before year-end.

Unlike our RCC trials, as we have previously discussed and disclosed, we do not believe our melanoma trial by itself will be sufficient for registration. However, we plan to use the data from this trial, coupled with refinements to our manufacturing process that we have discussed before, as a basis for the design of a second Phase III trial to be initiated after the data analysis is complete.

Let me now switch to our portfolio outside of our heat shock protein technology for a moment, Aroplatin specifically. The toxicology studies have now been completed and we remain on track to file an amendment to the current IND by mid-year.

This amendment will bridge the old formulation of our Aroplatin to the new formulation and allow us to initiate clinical trials with the improved formulation shortly thereafter. Our improved formulation of Aroplatin has demonstrated several advantages in both product handling as well as efficacy in in vitro as well as animal models over the earlier formulations of this product.

Switching gears outside of cancer, our AG-707 toxicology study is nearing conclusion and we remain on target for a mid-year IND submission for this product. This is our multivalent therapeutic vaccine designed to hit a substantial number of mutations expressed by genital herpes-infected cells.

Now I’d like to briefly update you on some key internal activities designed to support the commercialization of Oncophage. Our target market for our RCC launch has been identified as the top 20% of urologists or approximately 1,600 doctors. These doctors handle approximately 80% of RCC patients.

We have initiated outreach programs to key opinion leaders - urologists, oncologists and patients - as well as significant time spent developing thought leaders. In fact, for those of you who are planning on visiting ASCO, you will witness some of these activities on-site in our booth.

Our most active groups are the RCC Advisory Committee and our Speaker’s Bureau. We have also met with our advisory panels to discuss launch considerations and programs to expeditiously expend for treatment of other cancers and we have conducted extensive market research to fine-tune our reimbursement strategy.

We also remain very active in our publication strategy. Review articles from urology meetings appear in the American Journal of Urology and Kidney Cancer journals, a review on TML is in leukemia research and recently, an article on epidemiological mechanism of action of our vaccine was published in Nature. Should you need to obtain these copies of articles or any other peer-reviewed publications, please contact Investor Relations or visit our website.

Antigenics has also recently participated in several medical conferences - Southeast section of AUA (American Urological Association), Challenging Cases in Urology, NCCN, Society of Surgical Oncologists, ASCO GI Symposium, Urology Society of America - in order to improve our product name recognition among target urologists as well as oncologists.

We also completed an analysis of our ability to distribute Oncophage from our Lexington, Massachusetts facility, as well as handle distribution post-launch for the first 3 years of our forecast model.

Tying these pieces together is our new Enterprise Resources Planning system (ERP). This system will allow us to provide internal framework for commercialization, as well as provide the necessity of necessary tools to handle increased workflow. Most importantly, it will provide a strong foundation for adding sales force automation and customer relationship management as we prepare to launch Oncophage.

In summary, the second half of 2005 will be a very busy period for us, as we are getting ready for a potential BLA filing, as well as potential launch of Oncophage.

It is important for our shareholders to realize that as we engage in all these activities and we’re being extremely prudent with our resources as we get ready for these activities.

All essential time-sensitive activities are being implemented now. As for the discretionary activities, we are teeing up our systems so that we may execute expeditiously post-data.

That concludes my remarks and I believe we’re now ready for questions, Jack.

Marcus, would you please review the process for asking questions?

[Operator Instructions] First question, Mark Monane with Needham & Co.

Good morning, Garo, and thank you for taking my question. Could you please start off by helping us to understand the product characterization issues one more time? I appreciate you spending time early in the call, but I think there are some unanswered questions.

When you said - and correct me if I’m wrong - that the product characterization issues had been resolved, it sounds like the risk factor issue about the FDA’s decision of accepting the data hasn’t changed. And I know that you’re doing new studies to test the potency of the vaccine. So can you help us understand exactly what you mean by “the issues have been resolved”?

Certainly, Mark. I wanted to make it clear that we addressed this in our text of the call. Meaning that I did address this issue. If I haven’t addressed it clearly, I will do it one more time.

What we said is that the FDA today has agreed to not only the acceptance of the potency testing, which was agreed upon by the agency when they lifted the clinical hold in November of 2003. But they have agreed now to the validation, which sets the product specifications or the specification of the testing for potency. So, in essence, we have been able to narrow the very specific issues that concern the validation of this potency testing.

I also alluded, in my call, that we need to still overcome the fact that the FDA needs to buy into, based on data that we will plan to provide to them, that the product administered to patients prior to these developments, for which potency testing was not done, but we have frozen samples awaiting the testing to be completed, that the agency needs to buy into the strategy of declaring our product as well or sufficiently characterized at the time we administered the product to the patients.

That has not been done yet, because we have not provided the agency with two product characterizations information on product pre-November 2003.

Now I remember ---

I want to make it very clear that any speculation as whether or not Oncophage is now accepted by the agency as a sufficiently characterized product, those questions have disappeared. The questions of product pre-November 2003 have yet to be addressed, based on the acceptance of the agency’s new validation testing.

Got you. Now, I remember that there were some patients who were able to apply the test too prospectively and then you’re going back, since it’s a very large study, to the patients that you had previously treated because you had some saves in your refrigerator. Are you able to share any results of the prospective patients with us or have you had discussions on the results of those tests with this FDA, at this point?

Okay. So, you wouldn’t expect to have discussions with the FDA on those prospective testing. If you’re alluding to whether or not the agency will accept the product characterization of Oncophage post-November 2003, based on the specifications set - and Renu can comment on that - that is no longer an issue.

Okay.

That is no longer an issue.

Got it and the last question is the second Phase III trial seems to be smaller than the first Phase III trial, which is a little bit unusual. Is there lessons learned from the first Phase III that allow you to focus that trial more specifically? What was the decision around making it a smaller trial? Could you go over that with us, please?

Very simple, actually. I will let Dr. Renu Gupta address that issue.

Good morning, Mark.

Good morning.

The second study is [requirement of] randomization of 600 patients. There are two primary reasons for that. One is that in this study we are screening all patients for production of vaccine prior to randomization. In the previous study, that was not a requirement. So, about 8.0% of the patients in the previous study, who were randomized to the vaccine arm, we could not prepare vaccine for.

So, in the design of the study, we projected for a 15% vaccine production failure for the patients who would have been randomized to the vaccine arm. The actual was only 8.0%, so therefore we assessed for the higher number of patients to be enrolled in the study. So that was the main reason that we have a different sample size requirement for the second study.

And the second reason is our decision to have a hazard ratio of 0.65 for this trial. A question very often asked about is why did you take a hazard ratio of 0.56 for the first trial, which has been publicly disclosed now, and that was our understanding of what we thought would be a potential hazard ratio to look for.

The second trial is 0.65. We are, therefore, requiring less number of patients to be randomized in this study. As Garo mentioned earlier, the design of the trial are to -- we expect to be impacted based on the outcome of the Part 1 study and this has been discussed with the agency as well.

Okay.

So just to make things clear for everyone, the first trial included overage, which we now know, based on the design of the second trial, is not necessary.

So are people being randomized after the vaccine in prepared or are they randomized before the vaccine is prepared?

When randomization begins? We have not yet randomized patients, although we have IRB approval. The vaccine will be prepared for all patients who have eligibility criteria met, up until the point of histologic assessment. If we’re able to prepare a minimum of 4 doses of the vaccine, the patient will then be randomized to either receive the vaccine or be observational.

So there will be no patients, basically, who will not receive vaccine in the treatment arm.

Got it. Okay. Thanks for reviewing that and thanks for the added information.

Lei Zhong with Natexis Bleichroeder.

-- for Lei Zhong. When should we see the results from the retrospective potency testing in the previous lots?

We will not make the public until we discuss the results with the FDA. But suffice it to say that we feel highly confident that the results of the retrospective testing will meet the specifications for sufficiently pasteurized product, as set by the most recent understanding we have by the FDA. We feel highly confident that all those products will meet the specification.

Okay. Thank you very much.

[Terry Brand] with [Correlogics] Partners.

Hi Garo. How are you? Two questions, really. First is I wondered what kind of presence you guys were going to have as the ASCO meetings come up, in terms of how many presentations and for what. And the second is if you could give us a bit of a window on when you think the potential BLA filing questions might be answered [technical difficulty], ex-U.S. or U.S. arenas?

Okay. I’ll answer the second one and I’ll let Renu answer the first one. In terms of potential BLA timing, let me give you sequence of events. The first item on the agenda is the data.

The data needs to come out and be analyzed and if the data is positive - if the data is positive - then the next step is to initiate discussions with the FDA. And if those discussions go well and we have the agency’s concurrence that we will be able to file a BLA, we expect that to happen within 6 months of the date.

Now Renu can address the strategies concerning global registration OUS as well as the ASCO presentations.

Okay, good morning Terry. At ASCO, we have a poster presentation on an earlier melanoma study with Oncophage and I believe that’s on Monday and we will provide this to you very shortly.

With regards to the global strategy for filing, we’ve had discussions with the regulatory authorities in Canada and have their request to us to submit our data from Part 1 for the proposed label for the required indications. And as Garo mentioned earlier, when we analyze the data we are going to submit the common technical document to them as well.

With regards to the European authorities, we have discussions with the them with regards to scientific advice and those will continue, based on the strategy that has been outlined by Garo for our Part 1 study, while Part 2 is being launched globally.

Thanks very much.

Maged Shenouda with UBS.

Hi, thanks for taking my question. Just some clarification on the timing of the completion and data release from the first RCC trial, the first phase of it, and then also the BLA filing?

Okay. Just again to repeat, Maged, we said on this call that based on the monthly event rate -- and let me clarify what events means. As some of you may know, this trial is driven by events, which are either recurrences of disease or death and we have said previously that when we reach a certain number of events, which is slightly over 200 events, that the trial will be triggered for final analysis. That is how the statistics of this trial work for final analysis.

And while we do not have direct control of how many events occur on a month to month basis, because you cannot really prospectively predict the exact number of recurrences and deaths of patients in this trial, what we do is monitor the monthly rate. And try to extrapolate when we will be able to hit the appropriate number of events for triggering the final analysis.

And based on the recent rate of events, which I said on the call have indicated a slight slowdown from the earlier months, we now project that the prescribed number of events will be hit sometime in the August-September timeframe. Some time in that timeframe.

And the process beyond that, as you know, is we will spend some time - and estimate that time to be approximately 6 weeks to clean up the data - you have to verify the data that’s reported from the centers to an audit process. And at the conclusion of that, we will sit down and discuss the results with the FDA, as well as other regulatory agencies.

And by that time, we also are confident that we will have had all the information to be able to demonstrate or attempt to demonstrate that our product used in this trial was sufficiently characterized, although some of that information will have been tested retrospectively. And I don’t want to confuse you with the word “retrospective”, because we’re not talking about retrospective analysis. We’re simply talking about testing of vials post-administration to patients.

But should those vials indicate that our product was sufficiently characterized, we will make or attempt to make a compelling case to the agency that our product should have been deemed as sufficiently characterized all along. Although the information was made available to the agency subsequently, okay. With that, if we have the concurrence of the FDA, we anticipate that we will be able to file a BLA within 6 months.

Okay, great, thank you. So you’re looking at filing say in mid-‘06 if all goes well?

Anywhere from, I’d say, the first quarter to second quarter of ’06, if all goes well.

Okay, great, thank you.

Ren Benjamin with Rodman & Renshaw.

Good morning and thanks for taking the call, Garo. Can you talk to us a little bit about the new trial, the 600-patient - and Renu may have answered this earlier - has it started yet?

Good morning. Yes we have initiated IRB approvals and have had one successful investigator meeting for the Americas as well and are planning to have an investigator meeting for the European and Russian sites in September of this year.

I’m sorry. I guess I should have phrased it differently. When I meant started, have you dosed a patient yet?

Not yet. But we’ve already received IRB approvals, at, at least, I believe one or two sites in U.S.

Great. That’s great. Can you talk a little bit about - I don’t think it was in the conference call - AG-858 and the progress that’s being made there?

Certainly. Renu, would you like to take this?

Yes, certainly. So there are two important updates for that program. We are going to study our ongoing trial in an extended fashion by looking at the benefit of AG-858, by extending the dosing beyond the current 8 doses. So, that study will now extend into next year and we’ve also added additional sites, sites that have expressed a great deal of interest in this trial with the extended dosing.

Secondly, we are going to launch I guess a Phase IIb trial, which would be a combination of AG-858 with Gleevec versus Gleevec alone in earlier stage of these patients. We anticipate that study initiating in early third quarter. The protocol is far along in development. A lot of enthusiasm and interest has been expressed in this study. My colleagues have made presentations at Oxford at the European Consortium meeting and we are very excited about the launch of that study.

We also have plans to expand that molecule in the study of patients with AML and CLL, but that would be later, towards the end of this year.

I have in my old notes that with the AG-858 trial that’s ongoing right now, “Enrollment was scheduled to complete in mid-‘05”. Are the same number of patients being recruited and it’s just the dosing that’s taking longer so we won’t get data till much later? Or, are you increasing the size of the trial as well?

We also plan to increase the number of patients for two reasons. One, we would like to have a minimum of 8 to 10 patients that we can study with the 16 doses. And two, mid last year we changed our cell collection procedure to get a better source material for the preparation of vaccine and we want to ensure that we have at least 8 to 10 patients who have received vaccine with the new cell collection procedure as well. So, we expect the total sample size to be somewhere between 40 and 50 patients.

Great. Okay and one final question. We have ASCO coming up and you mentioned you have a presentation there on Monday regarding and older melanoma study. Can you talk you through the rest of the upcoming events, outside of Oncophage, that we can expect for this year?

Garo has certainly given you a summary. Is your question related specifically to publication and communication programs related to our molecule?

Yes, presentations at other conferences or publications would be great.

So I can share the following, which is work in progress. One is clearly the old study abstract, which we have done an extended survival follow-up and we’re quite excited about it. It will be presented on Monday at the meeting. Which is a poster presentation. In addition, there is a review article on kidney cancer being co-authored by lead investigators in the field, along with Antigenics to be submitted to JCO.

And then there is a manuscript in preparation now with extended survival follow-up data from an earlier study that was presented in 2003 at the ASCO meeting. And this is a study of 72 patients with metastatic RCC. Again, we’re very excited about this study and we expect to have the manuscript submitted somewhere in the third quarter, international target journal is JCO. And I think those are some key highlights of our publication plan for this year that I’m able to share with you at the moment.

In addition to that, Ren, also we are represented at a number of conferences beyond ASCO. Shortly after ASCO, I believe the following week, is AUA, American Urological Association, conference. That’s where a very substantial number of RCC experts -- I’m sorry, urologists who specialize in RCC will be attending. It’s a very large conference as well, well over, I believe, 11,000-12,000 attendees - not quite as large as ASCO, but a conference with a very, very large attendance.

In addition to that, we have a bunch of things in the fall. We will participate in ESMO in the fall, as well as ASH later on in the fall. So the activity level is picking up this year, partly because of the potential that when we have the data - upon positive data, obviously - this will be a watershed event. Because we are not looking to analyze any -- the declaration of success of our trial is not going to be based on any subgroup analyses.

This will be a very large trial, 800 patients, randomized trial, 1-to-1, that will be the largest of its kind in RCC, certainly but for that matter if successful it would have been the first successful trial in cancer vaccines. So, in expectation of the potential of this, we are upgrading our activities, both on the commercial side and overall exposure side.

Great. Thank you very much and good luck.

[Hariva Dosien] with D3 Capital Management.

Yes, good morning. A couple of questions about the first renal trial, first of all, if you would clarify in terms of the number of events that trigger the final analysis. Is it still 214 events efficient or have you increased the number of events? And also, in terms of which type of [technical difficulty] you need to see in order to discuss it with the FDA? There is some confusion over how it’s defined.

And lastly, given that the events are only a fraction less than 40% of the total number of patients, would it be considered an interim or a final analysis? Would a P of 0.05 be sufficient or would you need a smaller P-value?

Okay, so let me answer some of these questions appropriately. As we’ve said, the total number of events are a little over 200 and your 214 is approximately the right number. Those need to be clean events, 214 clean events, so that would require some level of overage and we’re in the process of trying to estimate what the appropriate overage should be for us to end up with the 214 clean events, if you will.

In terms of the analysis, this is a final analysis. It is not an interim analysis and we’ve made that point a number of times and if we’re not clear, I apologize, because we have used the term “final analysis” in all of our descriptions. So it is certainly not an interim analysis.

Thirdly, in terms of the benefit and let me articulate based on the hazard ratio that we have set. The reason or one of the reason we’re excited about this trial, aside from the fact that no treatment options exist for this patient population and aside from the fact that our safety profile has been very favorable so far, there’s another important consideration here. And that is the trial is designed to demonstrate approximately a 40% reduction in recurrences for these patients and that is a very large reduction.

If you were to translate this to more practical terms of what does this really mean to patients, in terms of an extension in life, we’re looking for measuring an extension in life that is in years and not in months. Based on the analysis or the way the trial is powered to show benefit to patients.

Renu, would you like to add anything more than this?

I would just echo what Garo has said, in that the study is powered to demonstrate a statistically significant difference.

So the 40% reduction is in percentage of patients in treatment arm versus the control arm?

So let me articulate this. What we’re looking for, a certain percentage of the patients who undergo nephrectomy, that is the removal of the diseased or the cancerous kidney, who are enrolled in this trial are going to be cured with surgery alone. And a group of patients in the trial will relapse and when they do, as you know, there really aren’t very many effective, curative certainly, options available for them when they recur. So what we’re looking for is a 40% reduction in the recurrence rate in patients who will recur.

Okay and the P of 0.05 is sufficient?

We have discussed our statistical trend with the agency and the agency has concurred with our statistical trend.

Thank you.

Ren Benjamin with Rodman & Renshaw.

Hi. Thank you for taking the call again. The definition of a clean event, please? I’m not too sure what you mean by that, Garo. And then, also, just more in general, other drugs are being developed for RCC, so just taking let’s say Onyx, how do you, what do you think of the drug and how does it compare to Oncophage? Or is it a threat to Oncophage?

Let me address the last question and then Renu will address the first question. Based on the data that we have seen, the Onyx drug appears to be a wonderful drug, but it is for Stage 4 patients. Just to be clear, Oncophage is being developed for the equivalent of Stage 3 patients. The difference is one is metastatic disease and the other one is non-metastatic disease.

Now that gets confusing because when we describe it as non-metastatic disease, clearly a very significant portion of the patients who appear to be non-metastatic when they enroll in our trial then manifest metastases later. And this is what we’re trying to reduce the rate of, the recurrence of this disease. But the two drugs are being developed for different patient populations.

If anything, we believe that down the road there may be reasons why the two may be complimentary to one another, particularly in the treatment of metastatic RCC. Where once again, though these drugs - the Onyx and other drugs - appear to be a wonderful new advancement, at least on the surface they don’t seem to be curative. And our objective would be could we combine the drugs in Stage 4 disease with the aim of potentially permanently benefiting these patients.

And Renu, would you address the question of what we mean by clean?

Yes indeed. Our primary data set for analysis for recurrence rate survival will be derived from the review of an independent Clinical Events Committee. That independent Clinical Events Committee is comprised of two primary radiologists, one adjudicating radiologist, and then adjudicating oncologist.

All the data, which is radiologic data, at the investigator site will be reviewed by the independent committee and they will make an assessment of the final number of events. So when Garo talked about the clean events, it was referring to the 214 to 220 events as deemed by the CEC.

Terrific. Thank you very much

Marcus, I think we have time for one more question.

Thank you. At this time, your final question comes from Karen Sterling with Atlantis Investment Company.

Thanks for taking my question. You have a lot going on that you say and I’m just wondering what that might do to your burn rate for the rest of the year. Could you comment on that please?

Peter, why don’t you --?

Yes. I think that our anticipation in terms of burn rate for the rest of the year is that there will be some uptick on 2004. But I think if you look at the way the trials have gone, we have two trials in the enrollment phase in 2004, whereas we will have one in 2005, I think that’s probably a reasonable assumption.

Okay. Thanks.

Okay. Thank you. We have an additional follow-up piece of information for you. The melanoma poster that Renu spoke about before will be available from 8:00 to 12:00 a.m. in Level 2, Hall C on Monday as ASCO.

To close the call, a replay will be available approximately 2 hours from now, through midnight ET on May 12, 2005. Please dial 800-642-1687 from the U.S. or use the international number, which is 706-645-9291. The access code is 5671279. The replay will also be available on our website in approximately 2 hours from now.

If you have any additional questions after today’s call is finished, please call me at 212-994-8244. Thanks again for participating in today’s conference call.

That concludes today’s Antigenics Q1 financial results and recent highlights conference call. you may now disconnect.

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