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Peregrine Pharmaceuticals (NASDAQ:PPHM)

Q1 2014 Earnings Call

September 09, 2013 4:30 pm ET

Executives

Jay Carlson

Steven W. King - Chief Executive Officer, President, Director, Chief Executive Officer of Avid Bioservices Inc and President of Avid Bioservices Inc

Jeffrey T. Hutchins

Joseph S. Shan - Vice President of Clinical & Regulatory Affairs

Paul J. Lytle - Chief Financial Officer, Principal Accounting Officer, Corporate Secretary, Chief Financial Officer of Avid Bioservices Inc and Corporate Secretary of Avid Bioservices Inc

Analysts

Joseph Pantginis - Roth Capital Partners, LLC, Research Division

George B. Zavoico - MLV & Co LLC, Research Division

Charles C. Duncan - Piper Jaffray Companies, Research Division

Operator

Good day, ladies and gentlemen, and welcome to the Peregrine Pharmaceuticals, Inc. First Quarter Fiscal Year 2014 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded.

I would now like to introduce your host for today's conference, Mr. Jay Carlson from Peregrine's Investor Relations group. Please go ahead.

Jay Carlson

Thanks, Kate. Good afternoon, and thank you for joining us. On today's call, we have Steve King, President and Chief Executive Officer; Paul Lytle, Chief Financial Officer; Joe Shan, Vice President of Clinical and Regulatory Affairs; Jeffrey Hutchins, Vice President of Preclinical Research; and Rob Garnick, Head of Regulatory Affairs.

Steve will begin by providing a brief overview of the company's progress over the last quarter, including our company-sponsored trials as well as investigator-sponsored trials or ISTs, and how these events set the stage for numerous near-term clinical data milestones. Jeff will then discuss our preclinical development program, with Joe then reviewing the clinical developments of the quarter. Paul will then finish with a summary of our financial results for the first quarter fiscal year 2014 and some insight into our subsidiary, Avid Bioservices. After our 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 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 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 Annual Report on Form 10-K for our fiscal year 2013 ended April 30, 2013, and quarterly report on Form 10-Q for the first quarter ended July 31, 2013.

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 forward-looking statements, whether as a result of new information, future events or otherwise.

I'll now turn the call over to Steve.

Steven W. King

Thanks, Jay, and thank you to everyone who is participating in today's quarterly call. This quarter, we were very active on multiple fronts including research, clinical and manufacturing. Our key focus is to advance the bavituximab clinical program, building on recent promising clinical data as well as the exciting data showing that bavituximab primarily works through an immune-stimulating mechanism of action.

Most of this data is set for print publishing in October but is already available online through the publisher's website, prompting our news release today. These results have spurred new preclinical research activities that include exploring exciting new combinations and different ways to use bavituximab. In particular, the new mechanism data has sparked interest from both academic and industry collaborators to explore combinations with other immunotherapy agents not previously considered. Doctor Hutchins will talk more about our ongoing efforts in this area, including highlights from his recent presentation at the Immunotherapy Congress in August during his discussion later in the call.

Over the last few months, we have been building on the excitement created by the immunotherapy mechanism data and have been actively engaging scientists and key opinion leaders in the field of immunology, with the goal of engaging their expertise as we advance the bavituximab program. We have been extremely pleased as to how these data have been received and the enthusiasm exhibited from the potential of bavituximab. We are looking forward to continuing these activities and supplementing these discussions with preclinical data for ongoing studies expected to come out in the next few months.

In addition to the immunotherapy research, there has been significant interest in the results presented at ASCO showing an 84% tumor response rate in HER2-negative breast cancer patients, highlighting the potential of bavituximab in this difficult-to-treat indication. Of course, our key company goal remains initiating the Phase III second-line non-small cell lung cancer study, which we have named the SUNRISE trial, by year end. Lots of activities on the clinical front that Joe Shan will cover during his prepared remarks.

While moving forward on the science front, we have continued to see strong performance from our contract manufacturing business, Avid Bioservices, with another good revenue quarter. All of this while strengthening our cash position, which allows us to advance our programs to our upcoming milestones, while we continue to engage in active partnering discussions for both our bavituximab and Cotara programs. Paul will talk about these developments during his prepared remarks.

With that, I'll now turn the call over to Dr. Jeff Hutchins.

Jeffrey T. Hutchins

Thanks, Steve. This has been a busy and exciting time for the preclinical group as bavituximab's new mechanistic findings have enhanced the way we are thinking about the future development of this novel drug candidate. From a preclinical perspective, our mandate was to chart a translational path that would best leverage these results within the most efficient timeframe and yielding efficient definitive results to allow in -- for consideration in further clinical development.

Beginning in June, we executed the first studies within an intensive preclinical program that utilizes a team comprised of Peregrine and academic scientists. These initial studies could provide preclinical proof-of-concept support for the clinical development of bavituximab in combination with other immunotherapy drugs, much in the same way as we have seen with the complementary immunostimulatory combination with docetaxel. These ongoing studies are expected to read out over the next several months, with potential to generate the necessary data to further our clinical investigations.

In addition, we are leveraging our ongoing investigator-sponsored trials to provide translational clinical data reflective of the preclinical findings. For example, as part of our liver IST, we are collecting patient tissue samples with the goal of assessing changes in cytokines that could help us understand bavituximab's mechanism of action in patients.

Over the last few months, I have had chance to present these data to scientific leaders, investigators and most recently, to the immunotherapy industry leaders at Cambridge Health Institute's Immunotherapy Congress in August. The interest and response from these interactions has been overwhelmingly positive, opening up many new collaborative opportunities that we will explore. We have now begun to appropriately insert ourselves into the very exciting and topical immunotherapy discussion. As such, you can expect to see us at scientific venues in the coming months as we continue to share these exciting data to the scientific community.

In parallel with these efforts, our academic collaborators have been actively pursuing a publication strategy to showcase these data. Their success has been realized with the publication of a manuscript in the American Association of Cancer Research's peer-reviewed journal, Cancer Immunology Research. This journal's aim is to report major advances in cancer immunology that span multiple disciplines within the oncology research community. Overall, these data have already garnered a great deal of interest in the immunology community. We look forward to updating you on potential developments in that area, apprising you of preclinical development decisions and expanding the immunology discussion in the coming months.

With that, I will turn the call over to Joe.

Joseph S. Shan

Thanks, Jeff. The clinical activities during the quarter focused on preparations for the start of our pivotal Phase III trial in non-small cell lung cancer and supporting the preclinical proof-of-concept program that Jeff just outlined for you.

The Phase III trial is named SUNRISE, an acronym which stands for Stimulating Immune Response through Bavituximab in a Phase III Lung Cancer Study. SUNRISE is a randomized, double-blind, placebo-controlled trial evaluating bavituximab plus the chemotherapy, docetaxel, versus docetaxel plus placebo in approximately 600 patients at over 100 clinical sites worldwide. These sites will enroll patients with Stage IIIb or IV, non-squamous, non-small cell lung cancer who have progressed after standard front-line treatment. Patients will be randomized into 1 of 2 treatment arms. One treatment arm will receive up to 6 21-day cycles of docetaxel at 75 milligrams per meter squared, in combination with 3 milligrams per kilogram of bavituximab weekly until progression or toxicity. The other treatment arm will also receive the same docetaxel regimen but in combination with placebo, weekly until progression or toxicity. The primary endpoint of the trial will be overall survival. Secondary endpoints include progression-free survival and overall response rate based on immune-related response criteria, given our current understanding of the action mechanism.

In addition, we plan to collect exploratory biomarker samples that may support and enhance our understanding of bavituximab's immune MOA in the clinic. There's increasing rationale for combining bavituximab and docetaxel as not only as a standard treatment for second-line non-small cell lung cancer that increases PS. Docetaxel also decreases immunosuppressive cells known as myeloid derived suppressor cells, which could complement bavituximab's immune mechanism, as Jeff described earlier.

SUNRISE will also have an independent data monitoring committee that will assess safety on an ongoing basis, as well as the planned interim and final efficacy analysis. Over the coming weeks, our team will be working towards selecting investigators, obtaining regulatory approvals with global health authorities, ethics committees and clinical trial sites and finalizing necessary operational details to initiate the trial by year end.

As Steve mentioned, we are making the necessary additions to both internal headcount as well as outsourcing partners to ensure a well-executed program. While our immediate clinical focus is on executing the SUNRISE trial, we are continuing to work closely with the preclinical group as the potential immunotherapeutic applications of bavituximab are both exciting and numerous. We anticipate some of the ongoing ISTs may begin to yield some immune correlative data over the coming months and look forward to providing updates as soon as they become available.

I'll now turn the call over to Paul, who will review the financial results from the quarter and update you on Avid Bioservices.

Paul J. Lytle

Thanks, Joe. Shifting gears now, let me spend the next few moments to cover a few financial highlights and our related financial goals. As Joe just emphasized, our clinical and regulatory teams are extremely busy with advancing bavituximab into Phase III development for the treatment of second-line lung cancer, representing a major market opportunity. And to achieve these goals, we are carefully managing our resources and our various sources of capital, including the capital generated from our contract manufacturing business.

During the recent quarter, our contract manufacturing business, Avid Bioservices, generated just over $4.5 million in contract manufacturing revenue. This is a solid start to fiscal year '14, and we expect contract manufacturing revenue for the entire fiscal year '14 to be between $18 million and $22 million based on current commitments.

Along with the work being done for our third-party clients, Avid continues to be an -- instrumental in providing drug supply for the bavituximab Phase III trial while also preparing bavituximab for potential commercialization.

Now turning to our cash position. We continued to maintain a balanced financial approach, ending the quarter with $41.6 million in cash compared to $35.2 million in cash at fiscal year end, April 30, 2013. This provides us sufficient capital to fund our operations through at least the first quarter of fiscal year '15 based on our current financial projections, giving us the needed flexibility to initiate the upcoming Phase III trial in second-line lung cancer while strengthening our position as we evaluate other opportunities, including ongoing partnering discussions.

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

Question-and-Answer Session

Operator

[Operator Instructions] Our first question comes from the line of Joseph Pantginis with Roth Capital Partners.

Joseph Pantginis - Roth Capital Partners, LLC, Research Division

A couple of questions if you don't mind. First, with regard to your stated goals of starting the SUNRISE study before the end of the year, and then you also say that you're partnering discussions remain active, how tied together or not are these 2 different goals? Do you require a partner to be in place prior to the start of the study? Or can you start the study independently?

Steven W. King

Sure, thanks for the question, Joe. Yes, so I think we've put ourselves in position where it's our intention to go ahead and be able to start the clinical study and to, in fact, complete the clinical study, if necessary, on our own. Our aforestated goal is to continue the partnering discussions. Obviously, I think the -- it is a driver for many of the partners to potentially be involved in the Phase III trial, on the operation of Phase III trial. So it becomes a, I think, a positive from a partnering standpoint. But we also recognize that we want to be able to control what we can control, and right now, we can control getting that trial up and running and executing it. I think we have a good solid team in place, brought onboard some individuals with significant experience at running Phase III clinical trials. Of course, a lot of experience on the regulatory side as well. So I think we're in a good position to execute on the clinical study, continue those partnering discussions and hopefully, under the right deal terms, be able to bring those 2 things together.

Joseph Pantginis - Roth Capital Partners, LLC, Research Division

Okay, that makes sense. And then, I guess I want to have a little bit of an immunotherapy discussion regarding the SUNRISE trial and especially after your growing database in today's publication in the AACR journal. The way Joe described the study is that you're going to be giving bavi in these patients until progression or toxicity. Is that what I heard correctly?

Joseph S. Shan

Yes, that's pretty standard. So basically, it's a maintenance phase after the patients receive the maximum cycles of chemotherapy.

Joseph Pantginis - Roth Capital Partners, LLC, Research Division

Sure. So I guess the nuance that I wanted to bring up here is, like, if you were to consider the guidance that the FDA had previously written regarding immunotherapy approaches, regarding progressive disease and also, clinical experience for drugs like YERVOY, for example, where you would see potential progression followed by regression. I was just wondering, are you looking to have some sort of monitoring of -- there, so -- or educate the physicians based on these new immunological data that you're finding here, where you might see progression in patients, but that it -- you're -- that you'd leave it enough time for the immune system to act?

Joseph S. Shan

Yes. And in a nutshell, yes, we have incorporated that feature into the protocol. We will be utilizing the immune-related response criteria and building in extensive training. We'll also have some central radiology interpretation as well.

Joseph Pantginis - Roth Capital Partners, LLC, Research Division

So in the sense that, I mean, even to be more simplistic on it, too, then -- and that's a great answer. Would you basically tell physicians almost directly, you're almost paraphrasing what's in the FDA guidance for the industry to say. Don't necessarily rush to take your patients off therapy, I mean, because of the delayed separation of Kaplan-Meier curves. I mean, that's the nuance I'm sort of looking for.

Joseph S. Shan

Yes, yes. Actually, that's described in the criteria that I mentioned.

Joseph Pantginis - Roth Capital Partners, LLC, Research Division

Okay. Understood.

Joseph S. Shan

Yes. This..

Joseph Pantginis - Roth Capital Partners, LLC, Research Division

And I guess just the last question is, as part of the Phase III, are you planning to have an interim analysis?

Joseph S. Shan

Yes, we are.

Joseph Pantginis - Roth Capital Partners, LLC, Research Division

Are you disclosing at -- the time point of enrollment or events?

Joseph S. Shan

Not at this point.

Operator

Our next question comes from the line of George Zavoico with MLV & Co.

George B. Zavoico - MLV & Co LLC, Research Division

A couple of questions about SUNRISE. Are you going to be using a lot of the same sites that you used for the Phase IIb trial to help accelerate getting this -- the trial going?

Joseph S. Shan

Yes, absolutely. We're looking at leveraging experience. Yes, I think some of the sites will be able to come up and get activated a little bit faster because they have prior experience. Some of the other -- some other sites might have other competing trials, but that's definitely in the strategy, leveraging...

George B. Zavoico - MLV & Co LLC, Research Division

Okay. In that regard, can you provide any guidance as to how long you project the enrollment may take and how long the whole trial may take?

Joseph S. Shan

Yes. I think we've stated previously that our goal is to get a trial that can be done and enrolled in 2 years' time. So I think we are monitoring that and selecting the best sites that we can to achieve not only that enrollment rate but also get the highest quality possible. And kind of to the other question, by -- by Joe, making sure we get as many sites that are really familiar with immunotherapy. I mean, that's important, too.

George B. Zavoico - MLV & Co LLC, Research Division

And can you say -- can you guide to how much the -- you might expect the trial to cost?

Steven W. King

Yes. Paul, you want to address that?

Paul J. Lytle

Yes. Generally, it's -- Phase III trials, George, are approximately about $100,000 a patient. So it's 600 patients. You're looking at around $60 million. That being said, these costs are going to be spread over a pretty long period of time with the 2-year enrollment, probably a 1-year follow-up. And then you even have longer periods of time in terms of other costs that come out of the trial. So those are probably going to be spread out over 3.5, 4 years' period.

George B. Zavoico - MLV & Co LLC, Research Division

Yes. Okay. And in that regard, Paul, you mentioned, since you're on the phone now, a sort of balanced financial approach. I mean, you've clearly used the ATM. Are you considering as well, I mean, you -- last year, you tried a debt offering, which unfortunately -- but didn't work because of what happened with the mixed-up arms of the trial. Avid is clearly a revenue-generating arm. Maybe you could leverage some debt off of that?

Paul J. Lytle

Yes. I mean, our goal is -- has always been to look at nondilutive capital for the company. Looking at a term loan or some type of leverage debt makes a lot of sense, assuming it doesn't have to be paid back in a relatively short period of time. So longer payment terms, maybe something that get you past kind of the Phase III readout. Obviously, leveraging Avid is key. So I think looking at those type of options, obviously revenue growth, looking at potentially new services that Avid could offer, expanding that revenue offerings and potential is also going to be a key driver for the company. And then obviously, we'll -- we go back to the equity markets when we need to, to maintain a balanced financial approach so that we can meet our commitments and meet our timelines based on what we've laid out.

George B. Zavoico - MLV & Co LLC, Research Division

Okay. And finally, one last question with regard to SUNRISE. It looks like essentially, apart from perhaps new -- looking at new biomarkers, how different, other than, of course, the number of sites and the number of patients, is it going to be from the Phase IIb trial? Any other differences?

Joseph S. Shan

It's very similar. And we're only looking at one dose level of bavituximab, and that's really the only difference. And then, of course, the sample size. Yes, as by design, right, Phase III is a confirmatory statistical exercise. So I think that gives us the best chance of replicating on what we think we saw in the clinical data off from the Phase II in a larger patient experience.

George B. Zavoico - MLV & Co LLC, Research Division

Did -- you mentioned in your prepared remarks, Joe or Jeff, I forget, that you're going to be looking at the cytokines in tumor samples. Some of the other markers you looked at that were published today looked very interesting. Are you going to be able to do that as well, for example, confirming the macrophage phenotype switch?

Jeffrey T. Hutchins

Sure. George, that's certainly our goal. We're looking at the quality of those samples first, and -- but that's certainly the goal is to look at MDSC levels, macrophage, whether it's an M1 or an M2 switch during time. And it is quite nice that we do have before-treatment and after-treatment samples. So we're -- we feel like we're well positioned to do -- make those kind of measurements.

George B. Zavoico - MLV & Co LLC, Research Division

So there'll be -- essentially be 2 biopsy samples before and after treatment?

Jeffrey T. Hutchins

If it's regarding the SUNRISE, that's not, no.

Joseph S. Shan

Not the SUNRISE, no.

Jeffrey T. Hutchins

We're -- SUNRISE, they're going to be exploratory, and they're not going to be tissue-based necessarily.

Steven W. King

Yes. So, George, I think kind of a lot of things going on with our clinical studies. So we have a number of ISTs that have been ongoing. I think that Jeff was referring to is the fact that we have been collecting tissue biopsy samples from some of those studies like liver cancer study or rectal cancer study that's been built into the trial as well. So I think those are things that we can do now. Those tissue samples have been collected, and based on the appropriateness, we can now look for some of these phenotype changes and macrophages and other cell types associated with bavituximab therapy. As far as the kind of go-forward plan, one of our other stated goals is to really potentially look at some combinations with other immunotherapies. Of course, in those clinical trials, we want to build in the ability to collect tissue samples to further validate in the clinical setting what we've seen so nicely in the preclinical study that was published today. But as far as SUNRISE trial, we obviously don't want to add a lot of complexities into our Phase III, and tissue biopsies certainly fall under that category. So we'll be looking at things like potentially peripheral blood and things that are easy to collect and look at from a clinical setting. So I think taken altogether, we've got a lot of opportunities to generate data over the coming months that, well, again, further help corroborate what we're seeing in a clinical setting with what we saw in the preclinical setting but also really helps guide the program into some exciting new combinations.

Operator

Our next question comes from the line of Charles Duncan with Piper Jaffray.

Charles C. Duncan - Piper Jaffray Companies, Research Division

First of all, congratulations on a nice article in Cancer Immunology today. Many of my questions were asked, but perhaps I could ask a few more details on SUNRISE. With regard to statistics, I'm wondering what you're assuming in terms of kind of a clinical benefit that kind of drives the size of the trial? If you could help us out with those powering assumptions.

Joseph S. Shan

I think we've guided in the past that we haven't released the exact hazard ratio we're powering for but I think we're looking -- we powered it for about a 2 months' difference in median overall survival. It's pretty typical, and we're talking in the hazard ratio range of between 0.75 and...

Charles C. Duncan - Piper Jaffray Companies, Research Division

You said 2 months, Joe?

Joseph S. Shan

2 months, yes, for median point estimate.

Charles C. Duncan - Piper Jaffray Companies, Research Division

Okay. That makes sense. And then in terms of -- I know you're not really disclosing the details around the interim analysis, but can I assume that to occur at roughly 50 or 60 percentage -- percent of the events -- and then also, do you accommodate an adaptive design? Is there any way to change the sizing of the trial prospectively?

Joseph S. Shan

The way the trial is designed and agreed upon by the FDA is not adaptive in nature in terms of sample size re-estimation. And I think it's a pretty standard, classic, pivotal sample trial design, I think something the agency is very familiar and comfortable with. Your assumption about the interim analysis is pretty close, so...

Charles C. Duncan - Piper Jaffray Companies, Research Division

Okay, it makes sense to me. Also, in terms of the percentage of patients, I guess one of the risks that I've seen in some other lung cancer trials is percentage of patients here in the States versus other areas of the world and being able to control whether or not a patient really is at Stage IIIb or IV. I know you've given some thought to that. What are the percentages that you'd like to see in terms of the number of patients? And then how do you control or how do you plan to control for patients actually coming in with -- at later stage of lung cancer?

Joseph S. Shan

Sure. Without going into too much detail, I mean, there's several design features, including the way we stratify our randomization to ensure some balance. Obviously, it's a large enough study that a lot of prognostic variables should balance out, like age or gender, for example. There are other features both from the randomization standpoint, as well as we can control capping in the amount of patients from any particular country or region. And that's something that we have some control over. So again, earlier, our goal is 2-year enrollment. Of course, we're going to see how that goes. If there's a particular region that's enrolling much faster than others, that's something we'll evaluate along the way. So I guess yes, there's several features that we've been -- that we've -- incorporated already into the trial design and execution plan.

Charles C. Duncan - Piper Jaffray Companies, Research Division

Okay. And then my final question is on collaboration. I realized that, as Paul said, you can start and possibly finish this trial with the capital resources you have. But seems to me that there is potential for collaboration that might have -- interest might have increased since all the immunotherapy focus in ASCO. Has there been an increase in bavituximab since then? And what is the feedback? And then finally, is Cotara still on the table as a potential source of collaboration?

Steven W. King

Sure. I can take that one. So yes, Cotara is certainly on the table as a good collaborative discussion point with potential partners so that certainly, there is another source of partnering activity. There's been -- I mean, I would characterize as a tremendous amount of interest with the new immunotherapy mechanism data. I think there's a lot of collaboration interest with companies that are actually very active in the immunotherapy space because of the nature of our upstream target, the fact that we're going after really a primary endpoint of control in the immune response to the tumor. It really creates a lot of opportunities with these downstream effectors, and of course, PD-1, PDL-1 and CTLA-4 were certainly hot topics at ASCO. But there's a lot of other opportunities with downstream inhibitors that we think are a great fit with bavituximab. So yes. So I think it just opens up a whole new world of collaboration opportunities well outside just the kind of where we've been historically with chemotherapy and other types of treatment, like radiation, and really opening up a whole bunch of new doors that are really a very intense area of research right now.

Operator

I'm not showing any further questions at this time. I'd like to turn the call back over to Steve King, President and CEO, for closing remarks.

Steven W. King

Okay. Thank you, operator. As you have heard, this is a busy time at Peregrine, with a lot of exciting and promising activities underway. Our goal over the next few months will be to continue to actively engage multiple audiences, the scientific, clinical and investment communities as well as potential partners. The recent bavi immunotherapy data has transformed our thinking about the program, opening up an abundant number of partnering and collaborative opportunities. We look forward to updating you on these activities as we continue preparations to initiate the SUNRISE trial and add value to the company and our shareholders. Thank you.

Operator

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

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