Avid Bioservices Inc (CDMO) 2015 Q3 法說會逐字稿

Good day, ladies and gentlemen, and welcome to Peregrine Pharmaceuticals, Inc.'s third-quarter fiscal year 2015 financial results conference call. (Operator Instructions) As a reminder, this call is being recorded.

I would now like to turn the call over to Christopher Keenan of Peregrine's Investor Relations group. Mr. Keenan, you may begin.

Thank you, Brandy. Good afternoon and thank you for joining us. On today's call we have Steve King, our President and Chief Executive Officer; Paul Lytle, our Chief Financial Officer; Joe Shan, our Vice President of Clinical and Regulatory Affairs; Jeff Hutchins, our Vice President of Preclinical Research; and Rob Garnick, our Head of Regulatory Affairs. After their prepared remarks, we welcome your questions.

Before we begin, we would like to remind you that during this call we will be making forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ. These forward-looking statements reflect our current views about future events and future performance, and are identified by the terms of use and phrases such as believe, expect, plan, anticipate, on target, and similar expressions identifying forward-looking statements. These risks include, but are not limited to, the risk factors detailed from time to time in our quarterlies and our filings with the Securities and Exchange Commission, including but not limited to the quarterly report on Form 10-Q for the third-quarter fiscal year 2015 ended January 31, 2015, 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. We expressly do not undertake any duties to update these forward-looking statements whether as a result of new information, future events, or otherwise.

And with that, I'll turn the call over to Steve.

Thanks, Chris, and thanks to all of you who are participating in this afternoon's call. This is an exciting time for the Company on many fronts. Our lead clinical program, bavituximab, represents the most clinically advanced agent that targets the immunosuppressive PS-signaling pathway, and we are driven to bring this product to the market and believe it has the potential to help change the way cancer patients are treated.

Bavi is in a unique position as a Phase III immuno-oncology agent that has shown great potential in combination with both current standard cancer treatments, such as chemotherapy, as well as emerging immuno-oncology agents such as those targeting PD-1 and PD-L1. Leading the way to bringing bavi to the market is our Phase III clinical trial evaluating bavi with the chemotherapy agent docetaxel in second-line non-small cell lung cancer. We continue to make great progress in this trial and are on track to complete enrollments in the study by year-end.

I have had the opportunity to visit with investigators in the SUNRISE trial, and I continue to see enthusiasm from the sites, as well as a very positive reaction to the recent immuno-oncology combination and translational clinical data coming from the rest of the bavituximab program.

Outside completing enrollment in the SUNRISE trial, our focus is to enter into new clinical collaborations, supported by all the recent immuno-oncology preclinical and translational clinical data we have been generating. This will allow us to further explore clinical combinations of bavituximab with approved and developmental agents targeting PD-1 and PD-L1 in multiple tumor indications. We expect these efforts to be quite visible over the coming months as the planning that is well underway comes to fruition.

On top of all the exciting clinical and preclinical developments, we have continued to see remarkable revenue performance from our manufacturing subsidiary Avid Bioservices. We are raising revenue projections for the current fiscal year and bringing on new capacity that will help spur future growth by the middle of this year.

This capacity will allow us to continue meeting the growing needs of our existing clients, while simultaneously allowing us to be ready for bavi commercialization. This business is in its strongest position ever as we head through the rest of fiscal-year 2015 and is in a great position for a very strong fiscal-year 2016.

We expect over the next few months to have the opportunity to further update you on scientific and clinical data at high-profile conferences; to be able to update you on the emergence of clinical collaborations to further explore the potential of bavituximab in combination with other IO agents; and to bring online the additional capacity at Avid that will help grow the business.

With that, I'll now turn the call over to Joe to discuss clinical development activities. Joe?

Thanks, Steve. As Steve just clearly outlined for you, while we remain focused on advancing bavituximab toward market approval, we're simultaneously laying the groundwork for expanding its potential use beyond non-small cell lung cancer. SUNRISE, our Phase III lung cancer trial, is progressing according to plan.

With more than 150 clinical centers spanning 14 countries now open for enrollment, our focus has fully transitioned from the startup to the enrollment phase, and we remain on track to complete patient enrollment by the end of this calendar year. We are also pleased with the progress made to date and encouraged by the positive feedback we have heard directly from investigators, who recognize the potential immuno-modulating mechanism of bavituximab and appreciate its safety profile to date.

As a reminder, SUNRISE is designed as a Phase III registration trial and has two planned interim analyses. The first is purely to assess safety, and the second will assess both safety and efficacy. As the interim analyses are triggered when a certain number of trial events are reached -- in this case death -- we cannot at this point guide to when these might occur. To protect the integrity of this double-blind trial an Independent Data Safety Monitoring Committee has been established to evaluate the data on an ongoing basis and make recommendations to Peregrine as to when the trial should be unblinded.

In addition to this most advanced clinical trial, our clinical pipeline is supplemented by trials all designed to expand the therapeutic potential of our novel immunotherapy, bavituximab. Today we announced that final data from a Phase I investigator-sponsored trial, which evaluated bavituximab in combination with paclitaxel in patients with HER2-negative metastatic breast cancer, has been accepted for publication in the peer-reviewed journal Cancer Medicine and will be available online in the coming weeks. The positive data from this trial along with data from two prior clinical trials in advanced breast cancer make this an exciting opportunity for the Company, and we continue to evaluate opportunities to advance the clinical development of bavituximab in this indication.

Also during the quarter, we announced data from the Phase II IST evaluating bavituximab in combination with sorafenib in patients with advanced liver cancer, which was conducted by Dr. Adam Yopp, Assistant Professor of Surgery at the University of Texas Southwestern Medical Center. Data demonstrated that the combination of bavituximab and sorafenib resulted in an improved time-to-progression of 6.7 months and the disease-specific survival of 8.7 months.

Importantly, the combination of bavituximab and sorafenib was well tolerated in patients with advanced HCC, with no indications of autoimmune adverse events, which have been seen with other checkpoint immunotherapies. This trial is also the subject of an oral presentation by Dr. Yopp at the Society of Surgical Oncology's annual cancer symposium towards the end of this month.

Also, recall that translational data from six patients in this study were presented last November at the Society of Immunotherapy of Cancer annual meeting. These data were generated through Dr. Dmitry Gabrilovich, a member of our Scientific Advisory Board and Program Leader of Translational Tumor Immunology at The Wistar Institute. These data demonstrated an increase in cytotoxic key lymphocytes in the tumor following just one cycle of treatment with bavituximab and sorafenib.

These results from treated patients are consistent with that which has been shown previously with PS-targeting antibodies in multiple preclinical cancer models. Specifically, that bavituximab can block immunosuppression within the tumor microenvironment and induce an antitumor immune response. Taken together we along with Dr. Yopp believe that further evaluation is warranted in a larger, randomized trial as resources permit.

Finally, over the past year we've also invested in developing new assays that we are incorporating into trials to assess immune changes within the tumor microenvironment and characterize changes in numbers and types of immune cells. Today, we announced that three posters have been accepted for presentations at the upcoming AACR annual meeting in April; and one of these posters will discuss data generated using a proprietary ex-vivo system using patient tumors which was developed by the lab of Dr. Scott Antonia, another member of our Scientific Advisory Board and the Thoracic Oncology Department Chair and the Immunology Program Leader at the H. Lee Moffitt Cancer Center in Florida.

We believe that these activities and accomplishments over the past year further build on our foundation for development of bavituximab in combination with chemotherapies as well as with immune checkpoint inhibitors. Meanwhile, we continue to expand our growing network of thought leaders as well as potential clinical collaborators, with the goal of spreading the word about our novel PS-targeting-based immunotherapy platforms and plan to advance the most promising combinations into the clinic as opportunities and resources permit.

And with that, I'll turn the call over to Jeff.

Thanks, Joe. As Steve mentioned, as part of our immuno-oncology development program we've continued to deliver snapshots aimed at elucidating and highlighting a broad picture of bavituximab in multiple preclinical indications, with the ultimate goal of uncovering the most effective immune-activating combinations.

When we initiated this program in June of 2013, we assembled a detailed plan designed to guide clinical development decision-making through a series of preclinical studies to lead into translational trials in patients. These steps are absolutely critical when building a foundation for future clinical trials.

I am proud of what Peregrine and our collaborators have accomplished in examining both the preclinical PS science and targeting platform, by looking at multiple combinations, thereby discovering the most robust immuno-oncology combinations, with us seeing today now how bavituximab potentially plays a role in breaking resistance to anti-PD-1 monotherapy.

Building on our strategy to disseminate our findings within the scientific and clinical medical communities, we recently presented data at the 2014 San Antonio Breast Cancer Symposium showing that the single-agent preclinical equivalent to bavituximab demonstrated statistically significant tumor growth inhibition, as well as statistically significant increases in the percentage of CD4 and CD8 tumor-infiltrating lymphocytes, and decreases in tumor-associated myeloid-derived suppressor cells, all of which are key indicators of immune activation in breast tumor models when compared to a control antibody.

These data confirm that the mechanism of action of bavituximab functions independent of PD-1 checkpoint blockade, therefore further highlighting our opportunity for additive or synergistic effects with IO combination therapy.

As well, at the Keystone Immunology Meeting, which brought together leading scientists across multiple disciplines, we presented data showing that PS-targeting antibodies when combined with an anti-PD-1 antibody displayed statistically significant improvements in the number of tumor-fighting immune cells, their activation signals associated with these cells, and the immune-activating cytokines in models of melanoma compared to an anti-PD-1 antibody alone. In addition, we saw that the cells that suppress the immune system's ability to recognize a tumor, such as MDSCs, were reduced by more than 40% in combination with the PS-targeting antibody versus anti-PD-1 antibody alone.

I hope that you can see from what you can see from our very successful IO development program is that our results are not only positive but very consistent across multiple tumor types. These data demonstrate that the combination of a PS-targeting antibody and a checkpoint inhibitor achieve statistically significant tumor growth suppression, as well as significantly increased levels of immune cell expansion and activation.

As Joe mentioned in his remarks, similar immune-activation events were observed in HCC patients, thus painting a consistent translational picture from preclinical to clinical as to the breadth of bavituximab's ability as a combination therapy. I can tell you that data from these studies and clinical translational data from trials are being well received; and as such, we plan to continue to actively engage members of the scientific and medical communities, with the goal of highlighting this potential of bavituximab throughout the coming year.

Looking to next month, two preclinical posters have been accepted for presentation at the 2015 AACR annual meeting, focusing further on defining the deep impact of PS-targeting agents in combination with immune checkpoint inhibitors on stimulating and sustaining T-cell activation. It is our strong belief that these data, along with the data that we have discussed with you over the past several months, support bavituximab as a potential treatment capable of converting these non-responding anti-PD-1 therapy patients into clinical responders.

With that, I'll turn the call over to Paul for an update on our financials and Avid business. Paul?

Thanks, Jeff. Now turning to our financials, it's important to note that we continue to closely manage our operations in line with our cap position while balancing our various sources of capital. One important source of capital is derived from our contract manufacturing business, Avid Bioservices, which generated $5.7 million in revenue this quarter and $17.4 million for the current nine-month period. This represents a 46% increase in revenue over the same prior-year quarter and a 10% increase over the same nine-month period.

As we look to the future, I would also like to emphasize that we have a strong backlog for future services in the amount of $29 million as of January 31. This current backlog covers services to be completed during the remainder of fiscal-year 2015 and into fiscal-year 2016.

Based on our fiscal year-to-date revenue and our anticipated completion of near-term projects under this backlog, we are raising our contract manufacturing revenue guidance from a range of $19 million to $23 million, to a range of $23 million to $25 million for the full fiscal-year 2015.

In addition to a strong revenue quarter, last December we shared with you strategic plans to expand our manufacturing capacity to help support the revenue growth of Avid, as well as creating sufficient manufacturing capacity for the potential commercial launch of bavituximab. Growing this revenue-generating business is very important to us, as it reduces the amount of capital and funding we would need to raise by other means. We have made significant progress this quarter in constructing this new manufacturing clean room, and we remain on track to commence manufacturing in this new facility during mid-2015.

Now, turning to expenses, we saw an expected increase in R&D spending this quarter to $11.3 million as we continued to invest in the SUNRISE phase III trial. This resulted in an increase in our net loss to approximately $13 million this quarter, with a corresponding increase in our net cash burn from operations to $11.1 million, representing our reported net loss minus noncash expenses.

In conclusion, let me say that our financial goals are centered on maintaining a solid cash position and investing these proceeds into our novel immuno-oncology program, led by bavituximab, and our revenue-generating manufacturing business. We will continue to closely manage our operations in line with our cap position while balancing our various sources of capital.

We look forward to keeping you updated on our progress, and we will now open the call up your questions. Brandy?

(Operator Instructions) Joe Pantginis, Roth Capital Partners.

Two questions regarding SUNRISE, if you don't mind. First, a logistical question. I know you don't give specific numbers, but do you feel that enrollment rates have been performing as expected? And then I have a follow-up.

Hi Joe, this is Joe. Yes, I think things are going pretty much according to plan.

Okay. Then more towards the broader lung cancer indication, I think it was last Friday Dr. Pazdur made some comments that -- it was in The Cancer Letter -- regarding the approval of Opdivo, and that docetaxel really shouldn't necessarily be the standard anymore or a comparator in clinical studies. I'm just wondering if you think that's going to have any potential impact on your ability to enroll patients into SUNRISE.

Yes, I can take a first stab at that. Yes, I think that we did get some questions on those comments that he had made. I think there's a few things to keep in mind.

One is that what we was specifically referring to there was squamous non-small cell lung cancer. In fact, those patients are actually excluded from our study; so we are a non-squamous non-small cell lung cancer. So we don't expect that that will have, I think, any overriding impact on enrollment in our study whatsoever.

I think in the broader scheme of things, the question is: well, does this somehow affect our trial design or in some way impact our overall program? And I think we are very confident that the way we have gone about things is focus on the things that we can control, number one, not what else is going to happen in the marketplace, because you never know.

But basically this was the reason we had an end of Phase II meeting with the FDA. We got clearly their buy-off on the trial design, which included the comparator arm. So I think we're very confident from our standpoint that we are on track; and if we have statistically significant results, positive in our study, that we should be in a great position for approval.

Joe, I don't know if you or Rob want to add anything to that.

Thanks, Steve. Yes; I totally agree. I know Dr. Pazdur pretty well. I've worked with in the past, and I think his comments on the squamous non-small cell lung cancer trial with Opdivo are right on.

However, as Steve said, we're in the non-squamous population, which is a totally different disease. And our agreements with FDA on the Phase III trial design are something that typically FDA is not going to back on and make changes and disagree with the endpoint and trial design.

So I think we are in a very strong position that, should the trial be positive -- as we would expect -- that we will be able to obtain a good approval, a relatively rapid approval for the product because we do have the Fast Track Designation. So I'm not worried about that. And again, I also agree, I think it will have absolutely no effect on the accrual of patients in the trial itself.

I do think though that the really great results that have been reported with Opdivo, it makes me particularly interested in combination trials with bavituximab. Because one of the real advantages of bavituximab is that it has an extremely good safety profile, which is actually highly unusual both in immuno-oncology drugs as well as in chemotherapy drugs in general.

So the ability to combine bavituximab with drugs like Opdivo -- and I'm sure Jeff has some thoughts about additional trials that he's thinking about -- but I'm sure in the future we're going to see these types of combination trials come to fruition. And this will lead to label expansions and a lot of other very positive things for the development of bavituximab as an immuno-oncology agent.

Joe, do you have any other comments?

No. Did Joe Pantginis have another question?

No, was just going to say that's very helpful, Rob; thank you. I guess even by the time SUNRISE reads out you will have already generated more data, both clinically and preclinically, to talk to the potential potentiation of the combination. That's something we're looking forward to. But thanks for the added color.

Yes, Joe, I think that's a great point. Just follow-up on that, I mean, I think that's exactly what Jeff was talking about earlier and Joe has been talking about, is this is an exciting opportunity to be able to combine with Opdivo and the other PD-1, PD-L1 inhibitors that are out there. I think that's a grand opportunity.

Because, while these are great results, not everyone is getting cured. I think what's needed is still to drive more patients toward being able to respond to these great new immuno-oncology drugs. And clearly we've shown in preclinical studies now some translational data that bavituximab has that potential.

So, I think it's just another exciting opportunity, and we look forward to addressing it.

Thanks, guys.

Thomas Yip, MLV & Company.

I guess I'll switch gears a little bit and focus on Avid Bioservices, because looking at same quarter last year Avid grew. I see revenue grew by $1.8 million; that's pretty impressive. So, I'm just wondering: the backlog of $29 million, how do you see the expanded capability of the new plant affect the amount of that backlog?

Yes. I think the backlog of business is at this point strictly based on the current facility. I think what we're doing is adding on the ability to really grow that significantly.

So I think it just really is twofold. Number one is it allows us to continue to grow the base business to meet the growing demands of our existing clients, as well as new clients that are coming in and, of course, at the same time be ready for bavituximab commercial launch.

I think that it's a great opportunity. I really view this as a great growth business. Clearly, the revenue growth this year we're expecting to be very nice and, again, really setting the stage for a really nice fiscal-year 2016 coming up. So I think, yes, it's great to have this new addition coming online just at a time when we maybe can take the most advantage of it.

Okay. You mentioned preparing for bavituximab US launch. I'm assuming with this new capacity it will be able to cover the anticipated demand in non-small cell lung in the US.

Yes. That's exactly what planning went into building out the facility -- was to be able to meet the commercial launch. Now of course, if we are as successful with bavituximab in as many indications as we think we can be then, yes, we may need another facility.

But at that point that will probably be easier to address. So yes, but -- we definitely built it really with bavituximab commercial launch and commercial supply in mind.

I think it's one of the other interesting things about the developments in the -- with Opdivo, for instance, in that they got accelerated approval really based on some great clinical data; but they were in a position to take advantage of that because they already had the manufacturing in place.

I think this is one of the beauties of the model we have here, which is that, since we do have this manufacturing capacity in hand, we do have the ability -- should we be fortunate enough to have some early good results come from one of the interim data looks in the study -- to potentially take advantage of that.

I think that's the other thing that's great from having this new facility online, is it allows us to be able to meet that. And Rob, I don't know if you want to add anything to that, but --

Yes, I think that's a really good point. A lot of companies have actually stumbled in the past because they had a drug that worked, but they weren't able to produce the satisfactory commercial supply.

But we certainly have sized and designed this plant in order to produce both the launch capability and actually out a number of years in the expansion of the drug into the marketplace. So yes, I agree with Steve; I think we should be so lucky as to have the problem of having to build another plant. That would be a good thing.

Yes, that sounds like a plan and definitely hope you guys hit that capacity and more. I guess one final point, just wondering: where will the cost of this plant show up in the P&L, and over how long of a period of time?

This is Paul; hey, Thomas. The current asset that we are building is currently tracked under construction in progress on our balance sheet. So the actual cost will be stored there. And then we'll depreciate this asset over number of years, and that will show up in COGS as we manufacture for customers.

Okay, got it. Thank you so much, guys, for taking my questions.

George Zavoico, Jones Trading.

I wanted to follow up on the Avid. Did you ever mention how much the expansion is going to cost? And if you have or if you can, how long before you get the return on that investment with the increased business through the backlog?

Hi, George, this is Paul. We haven't said exactly what the total facility is going to cost us, just from a competition standpoint. I think as soon as we build it, we are going to have kind of a launch party for the actual asset. It will show up actually in our balance sheet when it is officially launched.

In terms of capitalizing on this asset, I think our goal is to basically put as many customers into this facility as we can. Initially bavituximab will just need a handful of manufacturing runs to prepare for commercialization, and then the remaining amount of capacity is available to third-party customers. Depending on how we execute on our future potential business, I think the return on investment should be fairly quick.

Okay, good. In terms of your existing customers, could you say how much, for example, the largest customer, what percentage of the capacity is now by one or two or three of your customers? How dependent are you on one or two or three customers, in other words?

I think if you look at -- under segment reporting in our 10-Q, it breaks out the customers. I believe Halozyme Therapeutics represents approximately 80% of our revenue that's reported for the past quarter.

Okay. Thanks for that.

Moving on, with regard to SUNRISE could you describe a little bit about -- or have you disclosed how many events you have to have, have to happen for the interim analysis, the first one and the second one? And have those number events changed, and what affect does that have on the powering?

Hey, George; this is Joe. I think we have just given broad guidance. It's pretty standard. I think the first interim is on 33% of events. Usually, as I mentioned before, it's futility; yes, mainly you're looking at safety. Second one is a 50% event.

50%.

Yes, so that's not changed. We are not -- like I mentioned in my prepared remarks, we are not monitoring that or watching that daily. That's the job of the IDMC.

I see. Okay.

Yes, and I think that it's just -- again, we can't really obviously control when we get to those events. It's driven by patterns of patient enrollment and of course patient outcomes. So it's even more unpredictable to guess when those might be.

But it's a pretty standard sign, and any alpha hit was taken into account in the overall trial design.

Okay. Then finally, somewhat of a more general strategic question, it's becoming pretty clear I think that Opdivo and Keytruda -- that these checkpoint inhibitors that have already arrived on the market have tremendous efficacy and a durability response for a relatively small proportion, if you want to say 20% to 30% is small, of patients. And that combining checkpoint inhibitors such as bavituximab with either of those -- as already been discussed by you guys and one of the questioners -- could potentially greatly improve the efficacy without really compromising the safety.

From a strategic point of view, if you're Merck or Bristol-Myers, would you want to lock up the use of a second immune checkpoint inhibitors like bavi with just one of those, to capture more of the market or expand the market for a particular indication or into other indications? Is that a viable strategic -- is that a viable strategy for some of the big pharmaceutical companies? And Does that play into your discussions with some of the partners that you're talking to?

Yes, I mean, I think that clearly combinations are the name of the game name now in the immuno-oncology space. Clearly, we think, I think -- well, clearly we believe that based on our safety profile and what we've seen so far in the tumor microenvironment changes, as well as the actual data coming out of our studies, that we are potentially a really great combination partner with any of the PD-1, PD-L1 players.

Absolutely, these kind of things can come into discussions. I think from our standpoint we would like to be able to look at it as broad of a selection of those types of agents as we can. Because while in theory they all behave the same, you never know what you're going to see clinically.

But certainly at this point, there's no reason to believe a PD-1 or a PD-L1 is going to have a distinct advantage. So yes, I think that comes into the discussions.

I wouldn't rule out that we may have multiple collaborations ongoing different types of agents within the PD-1, PD-L1 space for that reason, from our standpoint. So yes, I think we want to explore those.

But at some point if we start to show efficacy and we can add to the value of the platform -- and I think that is beauty of combining bavituximab, is effectively we're not diminishing the size of the PD-1 market. In fact, we are only enhancing it by allowing potentially more patients to respond that otherwise might not respond.

So, I think that's absolutely very attractive and obviously the ideal from a pharmaceutical development standpoint.

In that regard, to maintain your independence perhaps as long as possible -- because obviously Opdivo and Keytruda are going to be pretty expensive drugs -- are various cooperative groups or potentially different sponsors could move into the combinations to maintain your independence and perhaps increase the value when you actually do get to the point of negotiating an agreement?

Sure, yes, I think there's lots of possibilities. Obviously one is direct collaborations with the pharmaceutical companies that have the drugs, in indications where they might not be approved yet.

Of course, once the drugs are on the market and becomes part of the standard of care, such as is happening in melanoma and now coming into squamous non-small cell lung cancer, effectively those studies could be run even independently because of the fact that they would be covered by insurance.

Then the third of course is the cooperative groups or other groups that may have access to the drugs or a supply of them that could run their own studies. So, what I can say is we're actively looking at all those different possibilities; and we want to put together, again, the best program that will allow us to answer the questions we're most interested in.

Okay, thank you for taking my questions. Thanks for the added clarity.

(Operator Instructions) Charles Duncan, Piper Jaffray.

Hi guys, it's Roy in for Charles. Thanks for taking the question. Just a follow-up on George's question about SUNRISE, I guess. Are you guys planning any presentations this year around the interims or just conduct of the trial, enrollment, or anything?

Well, I think other than maybe a trials in progress type presentation at ASCO, the interim data looks -- although, I'll let Joe describe them -- but they're probably worthy of their own standalone presentation.

Yes, at this point we don't have anything updated.

Yes. We're still blinded, so I mean, other than --

No idea about timing on those at all?

No.

Okay. Then these also aren't in your control, but the Phase I ISTs, any thoughts on when we might see data from those?

Yes, I mean, I think those we're obviously a little bit more actively involved in and helping to encourage the holders of those ISTs. We're hopeful that even this year we might be able to start to see some of the data coming from those studies.

Clearly, we had a little bit of data from one of the ISTs late last year, and early this year from the liver cancer study; more data potentially coming from that clinical trial as we complete some of the translational pieces of the data set; and as well as we have another clinical presentation coming up, I think at the end of March.

So yes, I think those we'll see a little bit more activity. And clearly as we start new studies then they'll start the clock ticking on potentially more data coming through.

In addition to those, I think as was mentioned during the presentation, we have other data coming from a collaboration with Scott Antonia and his group, and looking at some additional data for bavituximab. So yes, I think there will be a heavy dose of data coming from ISTs as well as other preclinical-type activities.

Okay, very good, thank you.

Thank you. I'm not showing any further questions at this time. I'd like to turn it back over to management for closing remarks.

Okay. I'd like to thank all of you again for participating in today's call. We strongly believe that the paths we are taking on the development front-end will add significant value to the bavituximab program: by expanding potential indications and combinations which helps ensure commercial success; along with the continued growth of Avid, which adds value through growing third-party revenues, which increases the value of the business, by helping offset the overall cash burn and -- perhaps most importantly -- allowing us to be prepared for bavituximab's success.

Taken together, all of these activities should increase shareholder value, and we look forward to that reflection in our market valuation. I thank you all again for your continued support.

Ladies and gentlemen, thank you for participating in today's conference. This concludes the program, and you may all disconnect. Everyone have a good day.