Avid Bioservices Inc (CDMO) 2007 Q1 法說會逐字稿

Hello, and welcome to the Peregrine Pharmaceuticals first quarter 2007 financial results conference call. All participants will be in a listen-only mode. There will be an opportunity for you to ask questions at the end of today's presentation. (Operator Instructions) For your information, this conference is being recorded. I would now like to turn the call over to Barbara Lindheim, Ms. Lindheim?

Good morning and thank you for joining us on today's call with the management of Peregrine Pharmaceuticals. We are here today to discuss the Company's first quarter fiscal 2007 results reported this morning. Before I turn the call over to Steve King, President and Chief Executive Officer, I would night to read the cautionary note regarding forward-looking statements.

This conference call may include statements that are not historical facts and are considered forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Peregrine Pharmaceuticals' current views about future events and financial performance. These forward-looking statements are identified by the use of terms and phrases such as believes, expects, plan, anticipate, on target and similar expressions identifying forward-looking statements. These factors include but are not limited to the risk factors detailed from time to time in Peregrine Pharmaceuticals filings with the Securities and Exchange Commission, including but not limited to the annual report on Form 10-K for the year ended April 30, 2006.

Investors should not rely on forward-looking statements because they're subject to a variety of risk, uncertainties and other factors that could cause actual results to differ materially from Peregrine Pharmaceuticals expectations. Peregrine Pharmaceuticals expressly does not undertake any duty to update forward-looking statements, whether as a result of information, future events or otherwise.

I'd like to now turn the call over to Steven King. Steve, you may begin.

Thank you, Barbara, and good morning, ladies and gentlemen. Before we begin the business part of the conference call today, I would like to start by taking a moment to remember the men and women who died on this day five years ago and to send our thoughts and prayers to our servicemen and women to protect our freedoms.

On this morning's call, as we have done on recent calls, we will provide a review of the status of our current lead programs. But first I would like to turn it over to Paul, who will provide a financial overview for the quarter. Paul?

Thank you, Steve. And thank you, everyone for joining us today. I would like to summarize our financial results for our first quarter ended July 31, 2006 and highlight some additional points.

For the first quarter of fiscal year 2007, Peregrine reported a net loss of approximately $5.5 million or $0.03 per basic and diluted share versus a net loss of approximately $4.3 million or $0.03 per basic and diluted share for the same prior year period. Total revenues for the current quarter improved to approximately $.4 million and were primarily generated from our wholly-owned manufacturing subsidiary, Avid Bioservices. This compared to total revenues of approximately $.2 million for the same quarter in the prior year.

During the third quarter Avid continues to be an important strategic asset for Peregrine as it provides The company with the internal expertise and manufacturing capabilities to develop and scale up drug production for our preclinical and clinical programs. Avid produces drug products for our ongoing clinical programs while working on a number of strategic fronts, including the continued development of a commercial scale manufacturing process for bavituximab, developing a manufacturing process for our second generation antibodies under our anti-phosphatidylserine technology platform including a humanized antibody. And developing manufacturing processes by new preclinical candidates that should fuel our future product pipelines and opportunities.

This was done while Avid was still able to generate revenues from outside customers to partially offset our R&D expenses.

Now turning to our expenses. We recorded approximately $6.2 million in total operating expenses this past quarter, which was approximately $1.6 million greater than our total operating expenses for the same quarter last year. The majority of this increase pertains to Research and Development expenses associated with our increase in clinical trial activities and our continued efforts to advance Peregrine's preclinical programs.

We also saw an increase in cost of sales of approximately $.2 million, primarily related to higher reported revenues for Avid, but were able to hold the line on SG&A expenses which experienced a slight increase of about $100,000 during the current quarter.

During the quarter ended July 31, 2006, we greatly improved our cash and cash equivalent position through the infusion of $16.4 million from financing activities. This infusion of capital has increased our cap position to $28.5 million as of July 31, 2006. Sufficient capital to support the development of our product candidates through at least fiscal year 2007, candidates which we believe have significant clinical and commercial potential.

With respect to upcoming events, we plan to continue developing new relationships with potential investors and enhancing our outreach to the investment community, including the near-term upcoming events at Bio Investor Forum in San Francisco this October, and the Rob and Ranshaw Healthcare Conference in New York City this November. We are dedicated to make every biotech investor aware of the trading symbol, PPHM.

This concludes the discussion of the financial results. I would now like to turn the call back over to Steve to provide a business update for the quarter. Steve?

Thank you, Paul. Since our last call, the Company has continued to make good progress in advancing the clinical programs for our lead product candidates, bavituximab and Cotara. We believe the remainder of fiscal year 2007 has the potential to be a breakout year for Peregrine's clinical programs, in particular, for bavituximab.

We anticipate progress in a number of areas including generation of compelling repeat dose and combination therapy data using bavituximab for the treatment of hepatitis C infection, commonly referred to as HCV, a clinical indication with significant commercial potential.

Another area of advancement is the acceleration of our bavituximab anti-cancer clinical trial program by completing an initial multiple dose combination therapy trial in major cancer types. This new bavituximab combination therapy trial we will run in India is a good example of our drive to continually adapt our development efforts in order to expedite our program.

In this case we are capitalizing on data generated by both the bavituximab HCV and anti-cancer programs to initiate studies that were originally planned for calendar year 2007. Thus, changing the entire landscape of the bavituximab anti-cancer program. We believe this clinical progress we anticipate this year, coupled with our enhanced communication outreach efforts, will ultimately be reflected in our share price which we believe is currently under negative pressure as a result of technical and broader market factors and thereby not reflective of actual progress being made at the Company.

I would now like to provide an update on each of our clinical programs and other operations during the first quarter of the fiscal year, starting with our bavituximab anti-cancer program.

First, a little background. Bavituximab is a monoclonal antibody-based product that for cancer therapy binds to phosphatidylserine, which is exposed on tumor blood vessels. Once the antibody is localized it works with the immune system to shut down blood flow to the tumor, resulting in anti-tumor effects.

Let's start our discussion of the bavituximab anti-cancer program with the exciting news that we announced this morning, about a new combination therapy clinical trial slated to begin shortly in India. This trial is a safety and PK study, which may enroll up to 12 patients. This study is a combination therapy repeat dose study that is designed to complement the ongoing US cancer study.

The combination of the US study and the India study should position us to move directly into larger phase 2 type trials once the studies are complete. Approximately around year end or early in the new year. Subjects will be enrolled based on the type of chemotherapy which they are slated to receive and not by tumor type. This should provide us with preliminary data and a variety of solid tumors.

The combination regimens include bavituximab plus docetaxel, gemcitabine, and carboplatin paclitaxel. These are among the most commonly used chemotherapy regimens for solid tumors although we do expect that the main tumor type that will be treated include long, breast and pancreatic cancers. The design of these bavituximab trials reflect insights from the extensive body of preclinical data in a variety of tumor types that support the fact that chemotherapy up-regulates bavituximab's target on the tumor blood vessels, allowing more localization of the drug and better anti-tumor effects.

These results have been published in a variety of different manners including both peer review venues, as well as presentations at scientific meetings. This is just an example of how our preclinical efforts are helping to guide our clinical programs as we move the program forward.

By launching clinical trials in India, we are following in the footsteps of global pharmaceutical leaders such as Pfizer, Glaxo, and Eli Lilly, who are now conducting major trials in India. This trial will adhere to internationally tested ICH GCP guidelines; and we expect that it should support further development efforts in both the US and abroad.

Not only does India have world-class clinical trial personnel and facilities, it also allows access to a large patient pool of patients here to participate in clinical trials that should allow for faster enrollment. We expect to initiate this study shortly and expect to complete enrollment within only a few months, potentially allowing top line results from the trial to be reported in the spring of 2007. We believe this travel beaches the first of our efforts to expedite our clinical development programs with other planned advancements in the upcoming months.

These efforts are made possible by the fact that we now have a growing body of safety and tolerability data to support both bavituximab and Cotara additional clinical trials. The ultimate goal of these efforts will be to expedite studies designed to generate new safety and possibly efficacy data which should end up supporting larger studies which will truly be able to focus on looking at efficacy.

In addition to making plans for the new trials this quarter, we continued our ongoing phase one all solid tumor trial in the US. As a recap, this is a single and repeat dose escalation giving bavituximab alone. The trial is continuing at five US sites; we have seen increased enrollment rates. And we are continuing to work with the FDA and the clinical sites to establish ways to further expedite the trial, including potentially protocol changes to loosen certain restrictions that are no longer relevant in view of our human safety data, as well as regional outreach efforts to increase physician and patient awareness of the program.

I would next like to turn to the bavituximab anti-viral program. Again, bavituximab is a monoclonal antibody-based therapy. And in the case of HCV treatment, it binds to phosphatidylserine which becomes exposed on infected cells and viral particles. The antibody then works with the immune system to directly destroy the infected cells and the viral particles themselves.

This quarter witnessed a major milestone for the bavituximab HCV clinical program when we announced top line data from the phase 1a single-dose trial. In the trial, escalating doses were given as a single infusion to each patient at 0.1, 0.3, 1 and 3 mg per kilogram of body weight. The trial enrolled 24 patients who were refractory or nonresponsive to prior HCV therapies.

Bavituximab treatment appear to be safe and well-tolerated with no dose limiting toxicities or serious adverse events. We saw signs of anti-viral activity at all dose levels. In the 1 and 3 mg per kilogram dose groups, 50% of the patients had at least a 75% reduction in viral [tighter] during this study with an average of 0.8 log reduction.

In addition, signs of anti-viral activity were seen throughout the 12-week follow-up period in patients at each dose level. These results were all the more noteworthy because they were produced using bavituximab as monotherapy, using just a single dose - a very demanding test for a drug in the difficult to treat HCV category.

Data from an additional 6 mg per kilogram dose group - along with final data from the entire phase 1a study will be presented at a major liver disease conference in late October. We are very pleased that the study results were selected for an oral presentation at this prestigious meeting.

This quarter, we also initiated a Phase Ib bavituximab HCV monotherapy trial. This again is a dose escalation study with four doses given over a two-week period. The trial may enroll up to 24 patients. Patients will be monitored for safety - pharmacokinetics as well as viral load changes. Patient treatment is well underway and expected to be completed before year end.

We currently expect to report top line results from this study in the first quarter of calendar year 2007.

Based on the encouraging data to date, we have now begun planning for an HCV combination therapy study. This study may be a single or repeat dose bavituximab treatment in combination with current standard of care therapies. These combinations are expected to include the currently marketed anti-viral drug ribavirin and/or the currently marketed immune stimulant drug interferon.

We anticipate that the combination therapy studies will encompass a number of targeted studies, each designed to determine the safety and effectiveness of different treatment combinations and dosing regimens. We anticipate that these studies will begin this year and continue into the spring of 2007. Data will be reported from each trial as it is completed.

In summary, we believe that the bavituximab HCV program is proceeding extremely well and we look forward to reporting further results in the coming months.

While advancing the HCV program, we are also continuing our efforts to expand the potential clinical indications for our bavituximab anti-viral program. HIV is currently our primary area of interest for potential new viral indications. This focus is based on the fact that reports indicate up to 40% of HCV patients are also HIV-positive. We've already generated positive data supporting the fact that bavituximab recognizes both HIV virus and HIV-infected cells.

In order to fully valuate the potential of bavituximab in HIV therapy, we have expanded our collaborations in the HCV area. Our current collaborators include investigators at Tulane National Primate Research Center, Duke University, as well as contract research laboratories.

Some of our collaborators at Duke University recently received funding from the Gates Foundation for studies related to their HIV vaccine initiative. As part of these studies, we will be working with these researchers to assess phospholipids as a potential target for combatting HIV.

Because the program is being conducted by the researchers at Duke, we're not able to discuss the details at this time. Needless to say, we are very pleased to be involved in this collaboration and the increasing recognition that phospholipids may be an attractive target in HIV infections.

We will provide an update on these studies as mutually agreed upon with our collaborators or at appropriate times for data generated internally or at contract research institutions. I want to note here that it is important to remember that university collaborators can be a very valuable asset to Peregrine - bringing us world-class expertise, access to cutting-edge researchers and facilities, and the potential for eventual support from key opinion leaders.

At the same time, these researchers operate on their own timetable and we have limited control when the study results are completed and when they can be made public. These studies are proceeding; and we will report on the results in due course.

A second area of focus for our preclinical anti-viral programs is the treatment of influenza and respiratory viral infections. Our stated goal has been to reach a go/no-go decision for the program in time for the upcoming flu season. And while we have not generated enough positive data to proceed with clinical studies this fall, we have also not produced data suggesting the program should be entered.

We have made progress in showing the potential of bavituximab in influenza. In May we reported that bavituximab completely inhibited replication of laboratories strain of the [H 5-in-1] virus, commonly known as Avian flu and fertilized chicken eggs. We are continuing these efforts to translate these signs of activity into the treatment of acute influenza or respiratory infections in animals.

Currently the key issues that we are studying revolve around how to best administer the drug, optimal dosing schedules and which anti-viral agents would be good candidates for combination therapy.

We're currently working with collaborators at Utah State University, Duke University, SRI, Baylor University and through contract research laboratories. Pulmonary administration of bavituximab is among the drug delivery issues we are addressing. We believe this route of administration may be ideal for respiratory infections since these viruses tend to lodge deep in the lungs.

Since bavituximab has a potential working combination with other types of therapy, we also plan to evaluate combination therapy with existing influenza drugs. At this point, it is not possible to predict when or if the animal testing will yield enough positive results to move the drug into the clinic. We'll continue these efforts and will report back at an appropriate time.

A third area of interest on the anti-viral front is in the treatment of herpes virus infections including CMV. We are continuing to work with our collaborators at UC Davis and the University of Minnesota to evaluate the potential of bavituximab for CMV therapy.

Two key areas of interest include the transplant and study where the common CMV virus can pose a life-threatening risk to patients, as well as mother to fetus transmission during pregnancy and childbirth where CMV can be damaging or even lethal to newborns. Each of these potential areas of interest require special studies to address safety issues to the patient, as well as to the organ or developing fetus in addition to addressing anti-viral activity.

Again, these studies are planned or underway and we will report updates when appropriate.

Next I'd like to turn to our Cotara brain cancer program. We are continuing our collaboration with NABTT for the Cotara brain cancer program. We have recently met with the directors of the program to develop ways to accelerate enrollment. And we are also launching enhanced outreach activities at the clinical sites to raise awareness of the program.

In addition, we're currently making plans to initiate a separate safety and efficacy trial to help speed the program. You can expect to hear more information on these efforts a little later this year.

I'd like to next turn to Avid Bioservices. The past several months have been a very busy time at Avid, where we have been working on a combination of external customer programs as well as Peregrine projects. For Peregrine, we've been scaling up production of bavituximab in order to build inventory in anticipation of current and upcoming trials, such as the India cancer study, combination therapy HCV studies, as well as other bavituximab studies which we are currently planning.

In addition, we've been working toward moving the humanized version of bavituximab into the clinic as well. By completing the bavituximab scale of activities now, we believe that it will be possible during the upcoming year to focus more efforts on external projects, while continuing to move Peregrine projects forward.

In conclusion, the new fiscal year is off to a strong start that we expect will be indicative of the critical year for Peregrine, marked by important progress in our multiple clinical trial programs. We believe that our increasing success in achieving clinical milestones and a growing body of positive human clinical data from our lead programs will provide powerful ammunition for our efforts to raise our profile in the scientific, medical and investor communities in a responsible and sustainable fashion. We also believe these milestones will be a key value driver that will ultimately be reflected in our share price.

We appreciate the continued support of our shareholders, collaborators, and advisers and look forward to being able to report on our continuing progress over the course of the year.

Operator, you may now open the floor to questions.

(Operator Instructions). Mike [Londale]. (indiscernible)

Glad to hear from you guys again. Steve, I have basically one real question going into -- you said, top line data going into first quarter of '07. And the reason the stock price has been down is due to market conditions. But from what I see right now in the field, I think that pushing this data back through another quarter right now, someone had news of that. And I am more concerned about the 10.5 million share short position over the last few months. And what is being done to see who is that short's position out there?

I will let Paul briefly address the short position, but what I can say is the clinical programs are all proceeding very nicely. Again, we do not feel the short position or the current stock price represents any activities at the Company. We are making good progress on all fronts. There is no bad news we haven't put out that we're holding back for a special occasion here. We are very diligent at putting at news. So there's really no reason behind the other activity that seem to be taking place in the market.

And Mike, we can only speculate on the reasons for the short position, since we cannot truly understand investor motivations. The short position should in no way be a reflection of what the Company is doing. We have more things going on right now at the Company than ever in the Company's history.

Our goal is really to stay focused on drug developments, continue to hit these milestones. And I think this temporary phenomenon should resolve itself as we do hit these additional milestones.

I understand, but my question is, what steps have you guys have done to look into who is in the short position?

Again, the information is very hard to find. Who the short person is or who the investor is holding the short position. I think all we can really do is focus on the business and continue to hit milestones. And I think the short position should resolve itself in time.

[Dick Syracuse]. Merrill Lynch.

By the way, that short position -- I think if you look at who exercised the 5 million warrants at $0.70, you will find them. In any event, my question.

If we could speculate with you, I would agree.

In any event, I realize that we're in kind of a news blackout on hepatitis C in advance of Doctor [Kadovski]'s presentation in Boston. And I understand that, that anything new or whatever has to come out at that meeting.

But I just really would like to ask you if the data you're seeing an ongoing basis regarding hep C is what you had hoped for?

I can address that. Based on the results of the phase Ia single dose study, I think we have been very, very pleased with the results. First and foremost, we are very happy with the safety profile we have seen so far. You don't get a lot of credit for safety profiles, but this is truly a first-in-class drug. Showing the safety of the drug was a critical milestone for the program.

So (indiscernible) signs of activity, anti-viral activity that we've seen in the initial study, was just really a bonus for us. And we couldn't be happier than to have those results in hand.

As far as the ongoing study, data is coming in. I can't really comment on that. We will comment when we really have enough body of data to really talk about. As with any dose escalation study, often the most interesting doses are the later treatment groups. So I would anticipate that as we are able to complete the study we may be able to come out with a little more data. The timing of that will of course be dependent on when the study does complete enrollment.

There is a follow-up period after the initial four doses over two weeks. And really collecting that data from those and putting the whole story together I think will be critical. And we certainly saw that in our initial phase Ia study. We are really -- it was at the end of the study where we had a clear picture of what was happening there.

Chris [Karra]. Newbridge.

Before I get to my question, Steve, you had mentioned just before the Q&A session that Avid was preparing a humanized version of bavituximab to go into the clinic with. What would that be for? What indication?

I think we are still evaluating that. We feel like it could have utility in either the cancer or the anti-viral setting. We had humanized the antibody as we moved into the clinic because often patients will develop what is known as a human anti [chimeric] antibody response or a hacker response.

We are evaluating those responses in our patients. We haven't obviously seen anything alarming at this point. So we are just continuing to move that forward with the idea that we could essentially implemented it and either the cancer program or the anti-viral program.

Would you have to start all over again? Would you have to go back to 1a?

No. It is our anticipation that we would be able to pull together that data from bavituximab in such a way that we would be able to more directly move into advance trials. Again, it's exactly the same binding part of the antibody. So basically it should allow us to predict how the drug will behave.

Now of course, we would have to do pharmacokinetic and safety studies, and that would all have to be built in. But I think everything we're learning about about the bavituximab program we would be able to apply to that. And really hopefully expedite the program.

Have any patients in the United States of Ia cancer trial been offered further treatment after their 10 weeks?

No, they haven't.

(OPERATOR INSTRUCTIONS). Sheldon [Fromm] from (inaudible) .

Congratulations on all the progress. Most of my questions have been answered. Curious if you could tell us a bit more about the India trials -- the duration of the trials, the patient population and so forth?

Sure, I would be happy to do that. Basically the trial we anticipate will be able to begin shortly. We think the duration of the trial, given the trial design, should not take more than a few months to enroll. The patient population are refractory to common therapies as part of the treatments. Again, it will be based on chemotherapy.

So we have our three different chemotherapies which will then be provided with bavituximab. Those patients will then be followed up. And again, the primary goals here are to really address safety as well as take a look at efficacy. And maybe if we see something, it will help guide us into a particular indication for Phase II studies.

This trial design is very similar to the trial design that Genentech used for their Phase Ib [Evastin] clinical trial.

Out of curiosity, what kind of cost savings?

Well the primary driver for going to India really wasn't overall cost savings. That is a bonus. I would guess that it is a little hard to draw direct correlations, because we're not running the exact same study in the US. I'm guessing overall the cost savings is maybe in the 30% or so range. But I think the more important factor is the ability to more quickly enroll this type of trial, based on the number of patients that are really eager to enter into clinical trials, such as the bavituximab program.

Roger [Adams], a private investor.

Thank you for this update - a very encouraging report on India development. My question really is a reference back to the last conference call, Steve, when you were commenting on the positive enhancement that you obtained from repeat dose protocols in animals compared to single dose.

I know you have only completed one or two cohorts in the current Ib trial for the full 12 weeks; but is there any basis for being encouraged that some of the enhancement from repeat dosing may continue and continue to see some of that in the current trial?

I guess, basically, I can't really comment on the ongoing clinical trial. You are correct that in preclinical animal studies, single doses by and large were relatively ineffective in the [Pachendi] virus system. And really with only upon multiple doses that we saw good day anti-viral effects.

We would of course anticipate that that would hold over to the treatment of patients. Right now, again we will report data from the ongoing repeat dose study as it becomes available.

But would also like to address the fact that basically this repeat dose study will really be the first in a series of combination therapy studies and dosing studies themselves, in which we will want to look at different dosing regiments. We're using the four doses over a two-week time period really to support multiple dose safety.

It doesn't necessarily mean that's the optimal dosing time that we will eventually end up with. So perhaps longer-term weekly dosing or maybe two or three fast doses and then weekly dosing will be the way we go. That we will have to address those in separate clinical trials.

So those studies again, I think you will be hearing a lot more about us as we move the program forward this year.

Member: And one quick follow-up on other overseas clinical trials. Is India going to be the sole focus of your overseas program? Or is there some activity in China and Eastern Europe as well?

We have not really looked too heavily at Eastern Europe. I think a lot of the benefits that maybe a few years ago that were there, such as competing clinical trials and what have you, really have all more or less gone away. I think the costs are about the same. And I think at the current time, the competition for patients is also quite high there.

We looked pretty extensively at our different options. We felt India really -- they really have built in the infrastructure to do Western-style clinical trials. Obviously, the language barrier is not a problem. And I think we are very excited to get into these initial trials and build our experience there.

We of course are looking at China as another potential market. So again, I think is we move our programs toward you will hear more about our efforts there.

Thank you very much for the good report this morning.

Michael [Quisbeck], a private investor.

Steve, last year in the letter to our shareholders, you included an entire paragraph towards our agent against I know terrorism, stating that the government was testing -- I'm sorry -- for over 20 indications. Also, last September you stated that those results would be in upcoming months.

I see in the 2006 letter to the shareholders that issue is no longer addressed. And I was wondering whatever happened to that? And whatever happened to our results that were coming in upcoming months over a year ago?

Essentially, initial studies were completed. We weren't really able to take those to a logical endpoint primarily because I think, really, the focus of many of the biodefense programs has really become influenza, which, as I addressed earlier, is really one of our key three areas we're focused on.

So really I think from a government standpoint, their focus has shifted from a general bioterrorism or biodefense to really a focus on influenza because it's obviously something that is likely to be problematic over the upcoming years. If the prediction about the Avian flu, for instance, come true.

So we do still have some of those studies that are ongoing. We will report on them as they coming again to logical endpoints. One of the things about any experimental program, and I will just use the H5 in 1 data we released back in May, is that really those results were the culmination of quite a number of experiments. And sometimes you do experiments and they don't work or you get results that aren't promising. And then you get results that are promising. And eventually you start to get consistent results.

So that is really our goal with these preclinical programs is to really mold them into the fact -- into the point where either we're getting consistently good results or we just determined that it is not a viable indication for us.

(OPERATOR INSTRUCTIONS). Chris Karra. Newbridge.

I'm a little confused about the timing for the top line repeat dose data. I guess you said it was going to be shown or you hope to have it shown in first quarter of '07. These centers like Bach and Kadovski that usually go very quickly to these private centers, and I think you have even indicated that you expect that trial to complete or be completely enrolled before year end, possibly long before year end.

Why would it take till first quarter of '07 to take a peek at that top line data?

Well, I think the issue is really the follow-up time period after you treat the last patient. So you are looking at again, a 12-week time period in which we have to gather the data. The patients are actually still going answer that full time period. And we are taking serum samples and doing testing on the patients. So really it's more of the follow-up time period versus the time to enroll.

Yes, we are very happy with both the clinical sites that are involved in the study. They have been excellent in moving the program forward very nicely.

And have any other investigators like the people at Duke and such given you any indication that they would think the humanized version of bavituximab would work better for a particular indication like HIV? Is that why you are really pursuing getting the humanized version into the clinics as soon as possible?

Really, I think the issue with the humanize was more as a protector, a protection against seeing hacker responses or human (indiscernible) antibody responses that would limit the dosing time. So I don't think there's any reason to believe one or the other would be necessarily better, other than the immunogenicity issues.

So we will really, I think, again as we move the programs forward and gather more data, be able to come to a logical conclusion on where we want to use that. I think it's really a good way if possible to separate out the anti-cancer program and the anti-viral program. Which they are truly completely separate programs. They happen to use the same agent, but it will end up being different dosing regimens, different combinations. So they will really be totally different programs at some point.

Dick Syracuse. Merrill Lynch.

In Boston, what will Dr. Kadovski be addressing on hep C that we haven't already heard about?

I think what will be presented at the conference will be the final results from the study. Again, we did put out top line data. We have not talked at all about the 6 mg per kilogram cohort. That will also be covered during the talks.

And that was the final question.

I would like to make a couple of closing comments. I'd really like to acknowledge the commitment, vision and hard work of our employees and advisers in helping us reach this exciting stage and also to thank our shareholders for the continued support. We believe that continued progress in our clinical programs will ultimately help create shareholder value, that is commensurate with the clinical and commercial promise of our unique technology. I would like to thank you all for attending today's conference call.