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Peregrine Pharmaceuticals' (PPHM) CEO Steve King on Q3 2015 Results - Earnings Call Transcript
Mar. 12, 2015 10:35 PM ET | About: Peregrine Pharmaceuticals Inc. (PPHM)
March 12, 2015 4:30 PM ET
Executives Christopher Keenan - Senior Director, Investor Relations Steve King - President and Chief Executive Officer Paul Lytle - Chief Financial Officer Joe Shan - Vice President, Clinical and Regulatory Affairs Jeff Hutchins - Vice President of Preclinical Research Rob Garnick - Head of Regulatory Affairs
Analysts Joe Pantginis - Roth Capital Partners Thomas Yip - MLV & Company George B. Zavoico - Jones Trading Roy Buchanan - Piper Jaffray
Operator Good day ladies and gentlemen and welcome to the Peregrine Pharmaceuticals, Incorporated Third Quarter Fiscal Year 2015 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 follow at that time. [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. Christopher Keenan - Senior Director, Investor Relations 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 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. And 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. Steve King - President and Chief Executive Officer Thanks, Chris, and thanks to all of you who are participating in this afternoon’s call. This is an exciting for the company on many fronts. Our lead clinical program bavituximab represents the most clinically advanced agents that target 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.
Peregrine 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 PDL-1.
Leading the way to bring 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 enrollment in the study by year-end.
I 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.
After 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 PDL-1 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 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 of Bavi that will help grow the business.
With that I’ll now turn the call over to Joe to discuss clinical development activities. Joe? Joe Shan - Vice President, Clinical and Regulatory Affairs 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 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 is fully transitioned from the start-up to the enrollment phase. And we remain on-track to complete patient enrollment by the end of this calendar year.
We’re also pleased with the progress made to date and encourage 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 and a certain number of trial events are reached, in this case depths, 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 un-blinded.
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 and 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 makes 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 in sorafenib is also 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 auto-immune adverse events which have been seen with other check-point immunotherapies. This trial is also the subject of an oral presentation by Dr. Yopp at the Society of Surgical Oncology at the 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 generative 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 T 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 and multiple preclinical cancer models. Specifically eating of bavituximab can block immunosuppression within the tumor macro-environment and induce an anti-tumor immune response.
Taking 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 macro-environment and characterize changes in numbers and types of immune cells. Today we announced that three posters have been accepted for presentation at the upcoming AACR Annual Meeting in April. And one of these posters will discuss data generated using a proprietary XVIVO 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, in 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 platform and plan to advance the most promising combination into the clinic as opportunities and resources permit.
And with that, I’ll turn the call over to Jeff. Jeff Hutchins - Vice President of Preclinical Research Thanks Joe. As Steve mentioned, as part of our immuno-oncology development program, we have 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 immune oncology combination. With us seeing today now how bavituximab potentially plays a role in breaking resistance to anti-PD1 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 pre-clinical equivalent to bavituximab demonstrated statistically significant tumor growth inhibition as well as statistically significant increases in the percentages 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 confirms 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, as 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 activated in 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 the tumor such as MDFCs were reduced by more than 40% in combination with the PS targeting antibodies 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 the 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 years.
Looking to next month, two preclinical posters have been accepted for presentation at the 2015 AACR Annual Meeting focusing further and defining the deep impact of PS targeting agent 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? Paul Lytle - Chief Financial Officer 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. And 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 amounts 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.
And 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. And 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.
And 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 continue to invest in the SUNRISE space retrial. This resulted in an increase in our net loss to approximately $13 million this quarter but a corresponding increase in our net cash burn from operations to $11.1 million representing our reported net loss minus non-cash 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 for your questions. Brandy.
Question-and-Answer Session
Operator Our first question comes from the line of Joe Pantginis from Roth Capital Partners. Your line is open. Joe Pantginis - Roth Capital Partners Hi, guys good afternoon. Thanks for taking the question. Two questions regarding SUNRISE if you don’t mind. First logistical question, I know you don’t give specific numbers, but do you feel that enrollment rate had been performing as expected? And then I have a follow-up. Joe Shan - Vice President, Clinical and Regulatory Affairs Hi, Joe, this is Joe. Yes, I think things are going pretty much according to plans. Joe Pantginis - Roth Capital Partners Okay. And then, more towards the broader lung cancer indication I think it was last Friday, Dr. Pazdur made some comments I think 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? Steve King - President and Chief Executive Officer Yes, I can take first. Yes, I think that we did get some questions on those comments that he had made. And I think there are few things to keep in mind. One is that, what we’re specifically referring to there was squamous non-small-cell lung cancer. In fact those patients are actually excluded from our study. So, we’re 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’re very confident that, and we believe we kind of about things is focus on the things that we can control number one, 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. And so, I think we’re very confident from our standpoint that we’re on track. And if we have statistically significant results positive in our study that we should be in a great position for approval.
Joe or Rob, you want to add anything to that? Rob Garnick - Head of Regulatory Affairs Thanks Steve. I totally agree, I know Dr. Pazdur pretty well I’ve worked with him 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 are 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 go back on and make changes at, and disagree with the end-point and trial design.
So I think we’re in a very strong position that should the trial be positive and as we would expect that we will be able to obtain a good approvals, relatively rapid because 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 we’ll have absolutely no effect on the core of patients in the trial itself.
I do think so that the - really great results that have been reported for Opdivo, it makes me particularly interested in combination trails 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 Joe has talked 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 one of other very positive things for the development of bavituximab as coming in oncology agent.
Joe, do you have any other comments? Joe Shan - Vice President, Clinical and Regulatory Affairs No, Joe, does Joe have any other questions. Joe Pantginis - Roth Capital Partners No, I was just going to say that’s very helpful Rob. Thank you. And I guess, even by the time SUNRISE reads out, you will have already generated more data both clinically and pre-clinically to talk to the potential potentiation of the combination. So that’s something we’re looking forward to, but thanks for the added color. Steve King - President and Chief Executive Officer Yes, Joe, I think it’s a very point swap 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, PDL-1 inhibitors that are out there. And I think that’s a grand opportunity because while these are great results not everyone is getting cured. And 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 pre-clinical studies and 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. Joe Pantginis - Roth Capital Partners Thanks guys. Steve King - President and Chief Executive Officer Thanks Joe.
Operator Thank you. Our next question comes from Thomas Yip from MLV & Company. Your line is now open. Thomas Yip - MLV & Company Hi guys, thank you so much for taking my questions. I guess I’ll switch gears a little bit and focus on Avid Bioservices because I’m looking at same quarter last year, Avid grew - actually 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 plan as fact the amount of that backlog? Steve King - President and Chief Executive Officer Yes, I think the backlogs business is at this point strictly based on the current facility. So I think what we’re doing is adding on the ability to really grow that significantly. So, I think it’s just its really two-fold. 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. And 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 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. Thomas Yip - MLV & Company Okay. And you mentioned preparing for bavituximab U.S. launch. So I’m assuming with this new capacity it will be able to cover the anticipated demand and non-small-cell lung in U.S.? Steve King - President and Chief Executive Officer Yes. So that’s exactly what planning went into. Building out facility was to be able to meet the commercial launch. Now of course if we’re successful with bavituximab and as many indications as we think we can be then, yes, we may need another facility. But at that point that will probably easier to address.
So, yes, but we’ve definitely built it really with bavituximab commercial launch and commercial supply in mind. And I think it’s one of the other interesting things about the developments and the with Opdivo for instance and 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.
And I think this is one of the beauties of the model we have here which is, 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 looks in the study to potentially take advantage of that.
So, I think that’s the other thing that’s great from having this new facility online as it allows us to be able to meet them. And Rob, I don’t know if you want to add anything to that but? Rob Garnick - Head of Regulatory Affairs 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’re certainly, have size and designs planned in order to produce both the launch capability and actually have the 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 out good doing. Thomas Yip - MLV & Company Yes, that sounds a very good plan. And definitely I hope you guys hit that capacity and more. I guess one final point, just one very - where will the cost of this plan show up in the P&L and over how longer period of time? Paul Lytle - Chief Financial Officer This is Paul, hi Thomas. So the current asset that we’re building is currently tracked under construction and progress on our balance sheet. So, the actual cost that will be stored there and then we’ll depreciate this asset over a number of years and that will show up in cost as we manufacture for customers. Thomas Yip - MLV & Company Okay, got it. Thank you so much guys for taking my questions. Paul Lytle - Chief Financial Officer Okay. Thanks Thomas.
Operator Thank you. Our next question comes from the line of George Zavoico from Jones Trading. Your line is now open.
George Zavoico
Hi everyone, good afternoon. Thanks for taking my questions. 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? Paul Lytle - Chief Financial Officer Hi George, this is Paul. Yes, 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’re 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.
And 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 for third party customers. And depending on how we execute on our future potential business, I think the return on investment should be fairly quick.
George Zavoico
Okay, good. And 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? Paul Lytle - Chief Financial Officer I think if you look at on the segment reporting on our 10-Q, it breaks out the customers. And I believe Halozyme Therapeutics represents approximately 80% of our revenue that’s reported for the past quarter.
George Zavoico
Okay. Thanks for that. And moving on, with regard to SUNRISE, could you describe a little bit about or have you disclosed how many events you have to happen for the interim analysis the first one and the second one? And have those number of events changed? And what does effect does that have on the powering? Joe Shan - Vice President, Clinical and Regulatory Affairs Hi George, this is Joe. I think we’ve just given a broad guidance, it’s pretty standard. The thing that first interim is on 33% of events, usually as I mentioned before its futility, mainly you look at safety, second was the 50% events.
George Zavoico
50%? Joe Shan - Vice President, Clinical and Regulatory Affairs Yes. So that’s not changed. And we’re not I kind of mentioned in my prepared remarks, we’re not monitoring that and watching that daily, that’s the job of the IDMC.
George Zavoico
I see. Joe Shan - Vice President, Clinical and Regulatory Affairs Yes.
George Zavoico
Okay. Steve King - President and Chief Executive Officer Yes, and I think that, it’s just, we can’t really obviously control, we’ll make it to those events and it’s driven by patterns of patient enrollments 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 on the overall crowd [ph] sign.
George Zavoico
Okay. And then, finally, somewhat a little more general to strategic questions. It’s becoming pretty clear I think that Opdivo and PD-1, that these checkpoint inhibitors are already arrived on the market have tremendous efficacy and a derivative response for a relatively small proportion if you want to say 20% to 30% of small patients.
And, that combining checkpoint inhibitors such as bavituximab with either of those has already been discussed by you guys to one of the questioners. Could potentially greatly improve the efficacy without really compromising the safety?
From a strategic point of view, if you’re market Bristol-Myers, would you want to lock up the use of a second immune checkpoint inhibitor like Bavi with just one of those to capture more of the market or expand the market for particular indication or tell there are indications, is that a viable strategic - is that a viable strategy for some of the big pharmaceutical companies and does that plan to your discussions with some of the partners that you’re talking to? Steve King - President and Chief Executive Officer Yes, I mean, I think that clearly combinations are the name of the game now in the immuno-oncology space. Clearly, we think I think, we clearly, we believe that based on our safety profile and what we’ve seen so far in the tumor macro-environment changes as well as the actual data coming out of our studies that we’re potentially a really great combination partner with kind of any other PD-1, PDL-1 players.
Absolutely, these kinds of things can come into the discussions. I think from our standpoint we would like to be able to look at it as broad 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 is no reason to believe PD-1 or PDL-1 is going to have a distinct advantage. So yes, I mean, I think that comes into the discussion. I wouldn’t rule out that we may have multiple collaborations ongoing with different types of agents within the PD-1, PDL-1 space for that reason from our standpoint.
So, yes, I think we want to explore those. But at some point, if we start to shift, to see if we can add to the value of the platform, I think that is the beauty of combining bavituximab is effectively we’re not diminishing the size of the PD-1 market, in fact we’re 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.
George Zavoico
And in order to maintain your independence perhaps as long as possible, because obviously Opdivo and docetaxel [ph] are going to be pretty expensive drugs. Are various cooperative groups or potentially different sponsors could move into these combinations to maintain your independence and perhaps increase the value when you actually do get to the point of negotiating an agreement? Steve King - President and Chief Executive Officer Sure, yes. I mean, I think there is, lots of possibilities. So obviously one is direct collaborations with the pharmaceutical companies that have the drugs and indications where they might not be approved yet. Of course, once the drugs are on the market and become 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 corporate groups or other groups that may have access to the drugs or supply of them that can run their own studies. And so, what I can say is we’re actively looking at all of 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.
George Zavoico
Okay. Thank you for taking my questions. Thanks for the added clarity. Steve King - President and Chief Executive Officer Yes, thanks George.
Operator Thank you. [Operator Instructions]. Our next question comes from Charles Duncan from Piper Jaffray. Your line is now open. Roy Buchanan - Piper Jaffray Hi guys, its Roy in for Charles. Thanks for taking the question. Just kind of a follow-up on George’s question about SUNRISE I guess, I guess planning in the presentation is here around the interims or just conduct of the trial enrollment or anything? Steve King - President and Chief Executive Officer Well, I mean, I think that was maybe trials in progress type of presentation at ASCO. The interim data looks how what Joe described in, but they’re probably not worthy of their standalone presentation. Joe Shan - Vice President, Clinical and Regulatory Affairs Yes, I think we don’t have it updated. Steve King - President and Chief Executive Officer We’re still blinded so I mean. Roy Buchanan - Piper Jaffray No idea about timing on those at all? Joe Shan - Vice President, Clinical and Regulatory Affairs No. Roy Buchanan - Piper Jaffray Okay. And then, these also aren’t in your control but the Phase I ISTs, any thoughts on when we might see data from those? Steve King - President and Chief Executive Officer Yes. I mean, I think those we’re obviously a little bit more actually involved in and in helping to encourage the holders of those ISTs. So I mean, we’re hopeful that even this year we might be able to start 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 dataset and as well as we have another clinical presentation coming up I think at the end of March.
So, yes, I think those will steal a bit more activity and then clearly as we start new studies and that will start the clock ticking on potentially more data coming through.
In addition to those, I think as was mentioned in the presentation, we have other data coming from collaboration with Scott Antonia and his group in looking at some additional data for bavituximab. So yes, I think there will be a heavy dose of data coming from the ISTs as well as other kind of preclinical type activities. Roy Buchanan - Piper Jaffray Okay very good. Thank you. Steve King - President and Chief Executive Officer Thanks Roy. Thank you.
Operator Thank you. And I’m not showing any further questions at this time. I’d like to turn it back over to management for closing remarks. Steve King - President and Chief Executive Officer Yes, I’d like to thank all of you again for participating in today’s call. We strongly believe that the path 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. Taking together all these activities should increase shareholder value. And we look forward to that reflection in our market valuation.
AI
