Peregrine Pharmaceuticals CEO Discusses F1Q2011 Results - Earnings Call Transcript

Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM)

F1Q2011 Earnings Call Transcript

September 9, 2010 4:30 pm ET


Amy Figueroa – Senior Director, IR and Corporate Communications

Steve King – President and CEO

Chris Eso – VP, Business Operations, Avid

Paul Lytle – CFO


Joe Pantginis – Roth Capital Partners

George Zavoico – MLV

Bill Dawson – LifeTech Capital


Good day, ladies and gentlemen. Welcome to Peregrine Pharmaceuticals first-quarter fiscal year 2011 financial results conference call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will be given at that time. (Operator Instructions)

As a reminder, today's call is being recorded. At this time, I would now like to turn the conference over to Amy Figueroa. You may begin.

Amy Figueroa

Thanks, Joe. Good afternoon and thank you for joining us on today's call to discuss our financial results for the first quarter of fiscal year 2011 ended July 31, 2010 and review our clinical development program. Participating on today's call are Steve King, President and Chief Executive Officer; Paul Lytle, Chief Financial Officer, Rob Garnick, Head of Regulatory Affairs; and Chris Eso, Vice President of Business Operations.

Before we begin, we would like to advise that this conference call includes forward-looking statements. These forward-looking statements reflect our current views about future events and financial performance and are identified by the use of terms and phrases such as believe, expect, 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 our 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, 2010 and Quarterly Report on Form 10-Q for the quarter ended July 31, 2010 which was filed today.

Investors should not rely on forward-looking statements because they are subject to a variety of risks, uncertainties and other factors that could cause actual results to differ materially from our expectations and we expressly do not undertake any duty to update forward-looking statements whether as a result of new information, future events or otherwise.

I would now like to turn the call over to our CEO, Steve King. Steve?

Steve King

Thank you, Amy. Let me start by thanking our investors and analysts for joining us for our quarterly conference call this afternoon. Let me start by saying that we believe the most important future value drivers for Peregrine lie in our multiple Phase 2 clinical programs and I'm pleased to report that over the past quarter, we have advanced these programs across the board. At the beginning of this quarter, we reported positive data at ASCO, showing encouraging objective response in medium progression-free survival data for our lead PS-targeting antibody, Bavituximab, in both lung and advanced breast cancer indications.

Building on this positive data, we initiated two randomized Phase 2B clinical trials for Bavi in non-small-cell lung cancer, representing two independent pathways toward commercialization. Our third oncology Phase 2 development opportunity is for our novel brain cancer therapy, Cotara, for which we also presented data at ASCO demonstrating its excellent targeting capability.

We are currently wrapping up enrollments in an ongoing Phase 2 trial in recurrent GBM which we expect to complete prior to year end. In addition, we have begun seeing increased activity in our Phase 1 clinical trial evaluating Bavi in HCV infected patients and are currently on track to also complete this study by year end, renewing interest in another important potential value driver for the company.

Taken together, we ended the quarter with several advancing clinical trial programs, many with interim data reads possible over the coming year and planning underway for several new trials to further explore the broad potential of our PS-targeting platform helping us to lay the foundation for what we believe can be an exciting year of clinical progress as we pursue multiple development opportunities toward what we hope will be successful commercialization of these exciting compounds in the future.

What I find most exciting about the coming year is that we are running clinical trials that have the potential of creating huge value for each of our clinical programs. Drug development is a long process that typically requires 10 to 15 years or more of investment in research, preclinical studies and multiple levels of clinical trials.

During this entire time, value is built into the program at each phase of development. And our Phase 2 oncology programs are at the point of generating what we believe can be perhaps the most significant value in this process.

Phase 2 proof-of-principle studies, generally the penultimate step in the drug development process.

Starting from our technology platforms built on powerful science to having three Phase 2 oncology clinical trials targeting independent indications, we have made important progress over the past several years. Today, we are clearly focused on executing our programs for future success by advancing the developments of our target therapeutics that have demonstrated broad therapeutic potential in multiple cancer and viral disease indications. And very importantly, our ongoing programs provide several opportunities for initial and potentially even subsequent indication should our efforts be successful.

Joe Shan, our Vice President of Clinical and Regulatory Affairs is currently in Europe to present at a Biological Therapy of Cancer Symposium cosponsored by the European Society for Medical Oncology. In Joe's absence, I will provide you with an update on our clinical programs which are advancing across the board.

Our lead clinical candidate is Bavituximab, a PS-targeting monoclonal antibody representing a first-in-class therapeutics. Our clinical trials have yielded consistently encouraging data in multiple oncology and antiviral indications, supporting this target therapy's broad therapeutic potential.

Bavituximab has also shown promising results as a part of many different combination therapy regimens as well as in both frontline and refractory patient populations. This past quarter, we reported at ASCO very encouraging objective response and median progression-free survival data from three separate Phase 2 clinical trials using Bavituximab in combination with chemotherapy. Final data from these studies will be presented at an appropriate time in the future.

The positive data from these trials enabled us to launch two new randomized Phase 2b studies in non-small-cell lung cancer, the first in refractory and the second in frontline patients. The design of these new trials supports our regulatory strategy to pursue two potential indications for Bavituximab within non-small-cell lung cancer. And the regulatory strategy we have developed has proven successful in the past for other blockbuster drugs.

For both our lung cancer trials, we continue to expand the number of types participating in these studies and we estimate completing enrollment in both trials by midyear 2011. It is important to note that as our frontline trial is an open-label study, we plan to report interim data at medical conferences as this trial progresses.

For our double-blinded Phase 2b refractory lung cancer study which we refer to as our flagship trial, we expect unblind top-line data from the trial by the year end 2011. If data from this trial are very positive, we plan to discuss the opportunity to file for accelerated approval with the FDA and/or conduct a pivotal Phase 3 trial based on these discussions.

Given Bavituximab's demonstrated broad therapeutic potential, we are evaluating expanding our Bavituximab clinical programs as our resources permit. For our investigator sponsored trial or IST program, we are currently reviewing a number of applications from clinical investigators who are interested in evaluating Bavi’s breadth of therapeutic potential, both in new combination therapies as well as new indications.

This cost effective program is gaining momentum and we are very close to having our first IST trial launch. Although the timeline for initiating these trials is driven by our investigators, as these trials are conducted under their rather than our INDs, we look forward to having a number of these ISTs running and providing interim data updates as these trials progress.

I would also like to spend a couple of minutes here updating you on our preclinical programs in viral disease for our PS-targeting antibodies. Since this work is currently in preclinical stage, we have not reported as prominently on the development progress each quarter. However, our work is advancing through collaborations with Duke University, UC Irvine, the University of Texas Southwestern Medical Center as well as the multiple collaborators under our DTRA contract.

These programs are validating the broad therapeutic potential and are adding to the growing body of research on our PS-targeting technology platform of novel antibodies. At an upcoming bio defense conference this fall, we plan to report data generated under our DTRA contract for our PS-targeting antibodies in viral hemorrhagic fever models.

Before turning the call over to Chris Eso for a discussion on Abbott, I would like to remind you of our upcoming milestones. These milestones include completing enrollments in our Phase 2 Cotara trials in recurrent GBM and reporting additional interim data from this study by year-end, completing enrollment in our Phase 1 Bavi HCV trial by year-end with data from the trial available in the first half of next year, reporting final data from our Phase 2 trials in non-small-cell lung cancer and breast cancer at an appropriate time toward the end of this year or beginning part of next year, data presentations including medical and scientific conferences as well as publications throughout the upcoming year and into next, expanding our Bavituximab clinical programs as our resources permit to further evaluate the broad therapeutic potential of Bavituximab and expanding our client base and future third-party work at Avid.

I will now turn the call over to Chris for a view of Avid’s business. Chris?

Chris Eso

Thank you, Steve, and thank you everyone for joining us today. Before going into the details for the quarter, I wanted to take this opportunity to reiterate the objectives of Avid and what it provides to Peregrine strategically.

Our objective for Avid continues to be to help offset the burn rate of Peregrine by not only bringing in third-party revenue for contract services, but also to manufacture Peregrine's clinical supply requirements and ultimately commercial supply requirements at a significantly reduced cost to the company.

That being said, as a strategic asset that is fully integrated with Peregrine, we are also in a unique position to offer third-party clients a broad range of bio-manufacturing services. While we provide services to Peregrine, we continue to broaden our relationship with our existing key third-party clients and continue to seek new anchor clients to go along with our existing ones. These anchor clients provide us a solid revenue foundation base in which to build from.

Currently we manufacture one commercial product, are in the final process validation phases for two other third-party client products and are beginning to plan for this critical phase of activities for Peregrine.

Now turning to the results for the quarter, for the first quarter of the fiscal year 2011, contract manufacturing revenues was approximately $1 million as compared to 2 million from last year. Although our first quarter fiscal year 2011 revenue generated from third-party clients declined year over year, our activities have remained high and we envision our overall level of activities will increase sequentially and remain stable for the remainder of the year.

Looking back historically, fluctuations in Avid's revenue are directly related to the level and/or mix of services between internal and external clients as well as the timing of manufacturing of lot release. The timing of lot release plays a critical role in this fluctuation as we only recognize manufacturing revenue upon release of these lots to our clients which makes up the majority of our revenue mix.

Based on the work schedule for the clients, for outside clients for the balance of the fiscal year, we estimate to generate contract manufacturing revenue from third-party clients of between 8 and $12 million during the fiscal year 2011.

Another important benefit is the flexibility and control that Avid provides to Peregrine on its own manufacturing operations. As we perform this work for third-party clients, we can utilize our capacity as needed to support Peregrine and we are using this opportunity to begin preparing for potential commercialization of Bavituximab which could be launched initially from our facility.

Before turning the call over to Paul, I would like to just end by saying we are actively seeking and will continue to seek new clients and are currently in ongoing discussions with potential new ones. We look forward to keeping you updated as we solidify potential new customer relationships.

Our contributions to Peregrine continue to be numerous, producing clinical supplies at a significantly reduced cost while covering our costs and allowing for potential commercial product launch should Peregrine's clinical programs be successful in the future.

With that, I will turn the call over to Paul and he will give you an update on our financials. Paul?

Paul Lytle

Thanks, Chris. Before I review the financial results for the first quarter of fiscal year 2011, I'd like to emphasize that we are closely managing our business, our cash position and our sources of capital to advance our later stage clinical programs.

Over the past several quarters, we have closely matched our capital needs with our various sources of capital and while doing this, we have continued to advance our multiple programs towards what we believe would be major value inflection point for Peregrine.

Now turning to the financials, total revenue for the first quarter of fiscal year 2011 was $3.2 million. This compares to total revenue of 6.8 million reported in the same period last year. This decrease was mainly due to a reduction in government contracts revenue due to the scope of research activity performed under the contract.

As you recall, this contract has provided funding of up to 22.3 million for the first two years ended June 29 of this year and this base period has been extended to determine potential next steps in the research program. And as we speak today, we are actively performing work under this contract. We will keep you informed as soon as we receive meaningful updates on the contract.

In addition, based on our experience we have gained under our first government contract, we have applied for additional government contracts and grants such as IRS Section 48B that provides up to $5 million in funding per company for qualifying therapeutic projects. We will keep you updated on these potential funding opportunities as soon as they become available to us.

In addition to government contracts revenue, contract manufacturing revenue decreased due to a reduction in the level and timing of activities as Chris just discussed.

Now let me turn to expenses. Total costs and expenses were 10.7 million this quarter compared to 8.9 million reported last year. This increase was primarily due to increased investments in R&D to support our two new randomized Phase 2b trials of Bavituximab in non-small-cell lung cancer.

Research and development expenses were 7.1 million during the first quarter of fiscal year 2011 compared to 6.1 million reported last year.

Turning to the bottom line, during the first quarter of fiscal year 2011, our net loss was 7.7 million or $0.14 per share. This compares to a net loss of $2.4 million or $0.05 per share reported last year.

Now let me shift your attention to the balance sheet. As of July 31, 2010 we reported 18 million in cash and cash equivalents compared to 19.7 million at April 30, 2010 and 12.8 million reported a year ago at July 31, 2009.

For a more complete discussion on our financial results, I encourage you to read our press release and Form 10-Q which are both available now on our website.

Looking forward, we will continue to use non-dilutive capital as our preferred source of capital and to reduce our overall reliance on the capital market. Over the past several quarters, we have closely matched our capital needs with our capital resources and we are investing in our clinical programs to drive our future success which we believe are the most important and significant potential value drivers for Peregrine.

In closing, I would like to emphasize our focus on building the awareness of Peregrine within both the medical and investment communities. We now have four analysts covering our stock, we have held over 50 meetings with institutional investors and we have presented at six investor conferences this year with four additional conferences on our schedule for this fall. These efforts are instrumental in building the investment community's awareness of our powerful science, our advancing clinical programs and our team that is dedicated in driving this progress.

Thank you for your time and your support of Peregrine. We would now like to open the call to your questions. Operator?

Questions-and-Answer Session


(Operator Instructions) Our first question comes from Joe Pantginis with Roth Capital Partners.

Joe Pantginis – Roth Capital Partners

Hey guys, how are you doing? Thanks a lot for taking the call. A couple of questions, if you don't mind. First, Steve, you mentioned in your catalyst obviously the first line lung cancer study is open label. I was wondering if you could provide any further color regarding the data readout potential from that study.

Steve king

Sure, I would be happy to. Thanks for the question, Joe. Yeah, I think that obviously as we enroll patients in the study, we will have ongoing data coming through and then we will have again because it is open label access to the data and what the patients were treated with. I think what we're trying to target is at certain points during the trial is to do an interim data analysis for patients that are treated up to that point that are at a certain length of time after beginning in the trial.

So I would anticipate in the first half of next year we should start to have multiple opportunities to present those data points. It's about an 80-patient trial and so we could pretty easily imagine that that they will give us a couple of opportunities at the very least to talk a little bit about the data, how it's maturing. And then of course as we get into completing the trial toward the middle of next year, then we will be looking at a more formal analysis of the entire trial for both tumor response rates and then progression-free survival as that data becomes available.

Joe Pantginis – Roth Capital Partners

Sure, great. Just to switch gears real fast to Cotara, obviously you are reaching another inflection point for that product with data expected by year-end. I was just wondering if you can just summarize for us again what the potential regulatory strategy might be since this is in recurrent glio and obviously it's in pretty much an unmet medical need here.

Steve king

Sure, I think this is a program that really what stood out about the program right from the beginning is really the number of long-term survivors in the trials that we've completed to date. Every trial had one or more long-term survivors out over three years. But really it's the median survival time. We have been averaging between 38 and 41 weeks in those studies. I think we'll have it as you alluded to, a nice opportunity to update another interim analysis from the ongoing 40-patient Phase 2 study. But 38 to 41 weeks is a pretty outstanding in this patient population which has pretty much historically been pegged right at 24 weeks.

So, we've been working very closely with Rob. We're starting to develop the regulatory strategy. Our goal is to really have a meeting with the FDA in the first half of next year, sit down with them and really lay out the regulatory pathway toward approval. Because this is truly an indication where there is a very high unmet medical need and even the drugs that are on the market have really done nothing for patient survival.

So we're – we are pretty excited about the opportunities for Cotara in that indication and look forward to rolling out that regulatory strategy in the first half of next year.

Joe Pantginis – Roth Capital Partners

Great and if you don't mind, just one quick last one here. When you switch fronts to the viral side for Bavi, obviously you have the contract for viral hemorrhagic fevers. Anything regarding your strategy on looking for other potential contracts for other viral diseases?

Steve king

That's a good question, actually. The viral indications for Bavi and even the broader PS-targeting technology platform we think are pretty exciting. Obviously Bavi itself is a stand-alone agent looking at hemorrhagic fever obviously as a Phase 1 HCV program.

Again, our goal is to finish the ongoing Phase 1 trial and really our goal there is to get into the combination therapy. Really where we see the utility of a drug much like the oncology setting is in combination with existing therapies. We've already got some very compelling data combining the drug with ribavirin and some hemorrhagic fever models and of course that's part of the standard of care currently and I think going forward in HCV as well.

But looking beyond that, one of the things we know in the infectious disease area is that so far every type of virus we have looked at does induce PS exposure on affected cells. And that really creates a vast number of opportunities, everything from immunocytokines which we're currently evaluating as part of our UC Discovery grant work, all the way to targeting nanoparticles which you could really basically take these nanoparticles, load them with different antivirals depending on the particular type of viral – antiviral indication and really specifically deliver your drugs to the infected cells, reducing the toxicity of the agent and really taking advantage of our technology platform.

So, and there's actually interest in all of those from both funding agencies as well as potential partners down the road. So I think there's a lot of great utility of that technology platform and the group here is looking at a number of different areas that we really think have pretty dramatic potential from a market standpoint but also just can build and build on what really is a platform that has so much utility.

Joe Pantginis – Roth Capital Partners

Great. Thanks a lot, Steve, for the added color.

Steve king

Okay. Thanks, Joe.


Our next question comes from George Zavoico with MLV.

George Zavoico – MLV

Hi, everyone; it is George Zavoico. I hope everyone is well. Thank you for the update, I much appreciate it, and looking forward to results later on this year and early next year.

A couple of quick questions. I guess the really important thing is just to wait for the data, so just a couple of quick questions. The IST trials, the cost to you is just going to be to supply Bavi, is that correct?

Steve King

Yeah, I think on the IST program, it's going to depend on the particular trial. I think the goal is to be able to just provide simply drug which of course we already manufacture and we're able to build inventory on, just to supply that for the clinical trials. Some of the trials will have a relatively nominal – we may provide some nominal support for those but I mean, very, very nominal funding as compared with things such as these randomized studies that we're currently running.

So I think what we're trying to do in evaluating the number of applications that we have through which I think is currently now approaching a dozen or more, is really to identify the investigator studies that really can lead to future potential indications or novel combinations that we really have an interest in.

And of course those vary from additional chemotherapy regimens all the way up to really we're excited about the potential of Bavi in combination with radiation and some of the other even targeted therapies that are currently on the market, so. But the cost of those is pretty nominal. And obviously we want to take full advantage of that. The downside of them of course is that we don't have complete control of the timelines but we may provide as much support to the investigators as we can.

Again, we're right on the edge of getting some of those up and running and look forward to doing that throughout the end of the year and getting into next year and this should be an ongoing program in which we're always starting new trials.

George Zavoico – MLV

Yes, I guess the interest – the level of interest also is somewhat of an independent validation of the technology or least to have interest in the technology and also it will come out to be positive. You had talked also from time to time about biosimilar development. Can you update us on what your thoughts are and what – your progress you've made on that front?

Steve King

Sure, would be happy to. So obviously biosimilar is an exciting new opportunity. There's finally a regulatory pathway opening up in the US. There's already been one in Europe. So this really builds on our manufacturing capabilities and drug development capabilities which really fit in very nicely with the Avid business and kind of the regulatory expertise we now have on board as well as playing into our clinical capabilities. So we are currently evaluating a number of different potential targets to go after.

I think you – we hope to be in a position here before too long to start to kind of roll some of those out as far as what our areas of interest are, where we see the opportunity and then kind of our general plan of action. So it's still a very active area of interest.

Again, we just feel like it fits in perfectly because of our internal capabilities and being a US manufacturer. But certainly between now and the end of the year, we should be able to roll out some of those plans.

And really again, the goal is to kind of keep those percolating through and utilize excess capacity to move again exciting compounds through that have a very high probability of technical success.

George Zavoico – MLV

Now in that regard, are you developing these to a certain proof of concept or proof of principle and that the plan is to partner them out?

Steve King

Yeah, I think that has been our primary focus is to develop them up to a proof of principle. I think the biggest hurdle for the biosimilars is almost from the beginning to be able to start the program off and to identify a cell line along with the methods for identifying compounds that really are similar to products that are on the market.

I think from that standpoint, the upfront cost is relatively minor as compared with the novel drug development where you've really got to get into later stage clinical trial studies to know if you've got an active compound.

So I think our goal is to really do the proof of principle, find those partners. Certainly in the right indication where we think there's a good potential for the Company and we can push it forward and the costs fit in with the other activities of the company, we may be able to take something a little further down the line.

But there's lots of interested parties and it really comes down to who can be nimble and active and make those compounds right from the beginning.

George Zavoico – MLV

Okay, that's – look forward to hearing more on that as that develops before the year-end. And then finally, you have been gearing up for these two Phase 2 trials and developing a lot of Bavi. Is there any correlation between your ramp-up in developing product and – sort of an inverse correlation really in terms of resources and capacity to manufacture Bavi as opposed to servicing third-party clients? Or do you have enough space and capability to service both? For example, if you do get a couple of new customers and you need to ramp up, will the Bavi production suffer accordingly or are you capable to have the space and ability and resources to service everybody satisfactorily?

Steve King

I think that we do have adequate resources available for again taking care of both external third-party clients as well as all the Peregrine needs. Kind of historically how we've operated is the third-party clients really fit into a production schedule that's established with the clients and then we really do our best not to deviate from that as much as possible and then utilize excess capacity for Bavituximab and Cotara as well as even things like the second-generation human antibodies which we've also looked at as part of the DTRA contract.

So I think one of the great things we have been able to implement at the company are the use of single-use bioreactors and in fact, we've given some talks on that and it's one of our areas of expertise at Avid. Those are great little units that basically for very minimal capital expenditures, you can bring in and establish again an additional thousand liters of capacity for relatively minor outlay. And that is given us a lot of flexibility and in fact we've been looking at Bavituximab in both the stainless as well as the single-use bioreactors.

So we really see that as a key for us being able to expand within our existing facility but also even in adjacent warehouse space where again if the need were there and we had third-party commercial clients that we think in pretty short order we can expand the facility and really expand our overall capacity. Right now, the goal is just to get the maximum use out of our existing facility, keep the margins as high as we can get them and take advantage of it.

George Zavoico – MLV

So, yes, it seems to me the industry is shifting over to single-use disposable type plastic bags and things for the bioreactors. The transition from one product to another is much easier when you do that; I mean much, much easier and much less costly, is that correct?

Steve King

It's fantastically easier. Basically at the end of the run, the entire bioreactor – like I said, the disposal part of it goes basically into waste and the next one is set up literally within 24 hours and you're almost ready to go again. So that is truly the power of them versus the stainless steel reactors which have a certain turnaround time of cleaning and sterilization and those sort of things.

George Zavoico – MLV

Okay, that's great. That's all I have. Thank you all and good luck in the next quarter.


(Operator Instructions) Our next question comes from Stephen Dunn with LifeTech Capital.

Bill Dawson – LifeTech Capital

Hey guys, it's actually Bill Dawson. Stephen unfortunately got pulled away but I've got some questions for you.

Many of my questions have been answered but I think I'm actually going to parlay off of George's last one in regards to what's going on at Avid. I guess my question is, the decrease that we saw this quarter year over year, if we get a little more color on that, is it due to constraints for getting ready for these two Bavi trials or is it more of a revenue recognition issue in that lot delivery or there actually decreased interest coming from third parties?

Chris Eso

Hi, this is Chris. It actually – it comes down to a timing and fluctuation of revenue recognition. So obviously a big portion of our revenue mix comes from the manufacturing production run.

And when there are certain lots that get pushed out in terms of when they get released and accepted by the client, it just affects on a quarterly basis the fluctuation. But I think if you look out for the full year, we are still forecasting to be in the range of 8 to $12 million of revenue from third-party clients. So it's not that we have a lower demand, but it's just timing for this quarter.

Bill Dawson – LifeTech Capital

And with the two Phase 3 products that you're working on given a hopeful approval of one of them, would you consider yourselves – you'd be involved in the production of the commercial material as well, so maybe an increase in production there?

Chris Eso

Yeah, absolutely. We – last several months ago announced that we entered into a commercial supply agreement for one of them that we're in the process validation and the other one that we're in process validation hopefully if that is successful, we will move to a commercial supply agreement as well on that one as well.

Bill Dawson – LifeTech Capital

Okay. Again, not to beat a dead horse, but capacity constraints. I'm just wondering again with the two Phase 3 trials, I am sorry Phase 2 Bavi trials coming up as well as third-party contracts and also the investigator sponsored trials, you do not see any constraints on capacity at Avid?

Steve King

No, in fact, Bill, we've actually been able to already build the inventory for essentially all the studies that are currently under consideration. So that drug has already been made. Again, we take advantage of open production slots to build inventory for our planned studies.

Obviously we're not trying to build more inventory than we need, but certainly to make sure that that does not become a constraint. And so kind of how we view the business going forward is as Chris mentioned, we have already one commercial product that we produce for (inaudible). We have a number of other later stage clinical products that are in the facility.

So really the goal is to build the business on commercial production eventually because that's really the most routine and most reliable source of revenue once you get into that sort of routine production.

So we are looking at really actively the existing facility, how we maximize the use of the facility. Of course for Bavituximab that can come in the form of process improvements, higher producing cell lines, there's a lot of ways we can influence that. But also looking at the future of building out the adjacent warehouse space. That's where the disposable reactors are very appealing. They give you the ability to really build a lot of capacity in a relatively short amount of time.

And again, quick turnaround time between production runs which then has a direct impact on your overall facility capacity.

So we're definitely keeping our finger on the pulse of that and making sure that we're able to more than adequately take care of our all of our clients as well as Peregrine's needs.

Bill Dawson – LifeTech Capital

Good. Moving away from Avid, next question has to do with the two patents that you guys just received at (inaudible) that is used in imaging. Do you guys have plans to move forward using these antibodies as an imaging agent?

Steve King

That's a great question. We've already got a lot of the proof of principle work done. In fact it's pretty much a validated technology in a preclinical standpoint for imaging.

So we view that as something that does have some internal interest in that we already have some if you will antibodies beyond Bavituximab that have some really nice utility in that area. We are looking at what it would take to produce those agents, what additional regulatory pathway would be available for developing those compounds.

And this I think really creates two opportunities, one for Peregrine if we have the existing resources available, but also from a partnering standpoint really opens up a lot of doors because there are obviously many companies out there that specialize in imaging and diagnostic agents. And so it's just another great example of the PS technology platform and where we see it has so much utility across different areas.

Bill Dawson – LifeTech Capital

Next question briefly about the government contract. We have gone past the 45 day extension. Can you give me some color on the conversations you're having with the DTRA and where we might be in terms of possibly renewing?

Steve King

So basically we have an active open dialogue with TMT regarding the contract. Every indication we have is that we should be moving forward with additional experiments under the contract. Essentially, the situation was we came to the end of the two-year base period which was all basically preset if you will experiments that were run. And that was a great opportunity to take a look and okay, what is the data telling us so far, what are the most promising indications, the best dosing regimen, dosing level.

So really learning more about the drug during that time point. Now let's refine it as we move forward.

So again, every indication is that we should be moving forward with additional experiments. We expect to be able to bring that to fruition anytime now. So beyond that, it's just basically moving back and forth and going through the works.

Bill Dawson – LifeTech Capital

Okay. Just one last question and I'll jump back in the line here. Again on the antiviral properties here, the co-infection trial that should be coming to an end at the end of this year, do we know if we do move forward on this if it will be in HCV or will it be another co-infection indication?

Steve King

Well I think even the co-infection trial was primarily an HCV study. So HCV is currently – we're operating under the IND for HCV. That's where we see the biggest market opportunity. Again, as I alluded to earlier, we've seen some really interesting compelling data when we combine Bavituximab with direct antivirals such as ribavirin.

And so that's obviously now currently part of the standard treatment regimen and I think even will be once telaprevir comes on the market.

So I think it gives us some great opportunities because we really fit in on the immunotherapy side of things and clearly although interferon is a great drug and it's helped a lot of people, it also has some significant toxicities associated with it.

So really that's the area where we see a great fit for Bavi is sort of as a potential immunotherapy replacement and again, that fits in imperfectly with the antivirals where we are already generating great data.

So I would anticipate as we move forward, we want to look at some combination therapy studies with the antivirals and primarily in an HCV setting. Now depending on how the data comes out, we may choose to modify that approach. But certainly HCV is our primary target.

Bill Dawson – LifeTech Capital

Any thought on possibly moving forward with a drug cocktail in HIV as well? Obviously what the data shows but –

Steve King

Yeah, I think we'll let the data drive that discussion. But I think absolutely. Again Bavi is really designed if you will for combination therapy with direct antivirals in the infectious disease area.

Bill Dawson – LifeTech Capital

Okay. Well thank you very much, guys. I appreciate it.

Steve King

All right, thank you.


I am showing no further questions. I'll now turn the conference back over to Mr. King for closing remarks.

Steve King

Okay, I would like to thank everyone again for their interest in following our clinical progress. We will continue to work hard to accomplish our planned milestones and we will keep you updated on our advancing programs in the coming months and as this fiscal year 2011 progresses. With that again, thank you very much.


Ladies and gentlemen, thank you for your participation in today's conference. This concludes the program and you may now disconnect. Everyone have a great day.

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