Amy Figueroa - IR, BioCom Partners
Steven King - Chief Executive Officer, President, Director, Chief Executive Officer of Avid Bioservices Inc and President of Avid Bioservices Inc
Robert Garnick - Head of Regulatory Affairs
Joseph Shan - Vice President, Clinical and Regulatory Affairs
Paul Lytle - Chief Financial Officer, Principal Accounting Officer, Corporate Secretary, Chief Financial Officer of Avid Bioservices and Corporate Secretary of Avid Bioservices
Jason Butler - JMP Securities LLC
George Zavoico - McNicoll, Lewis & Vlak LLC
Peregrine Pharmaceuticals (PPHM) Q1 2012 Earnings Call September 9, 2011 11:30 AM ET
Welcome to the Peregrine Pharmaceuticals First Quarter of Fiscal Year 2012 Conference Call. I would like to remind you that today's call is being recorded. [Operator Instructions] I would now like to turn the call over to Amy Figueroa.
Thanks, Jerome. Good morning, and thank you for joining us. On today's call, we have Steve King, President and CEO; Paul Lytle, CFO; Joe Shan, Vice President of Clinical and Regulatory Affairs; and Rob Garnick, Head of Regulatory Affairs.
Steve will begin by providing an overview of our clinical progress over the last quarter and highlight our upcoming clinical data and regulatory meeting milestones. Joe and Rob will discuss our clinical and regulatory plan as we advance our 3 Phase II clinical programs and Paul will wrap up with a review of our financial results for the first quarter of fiscal year 2012 and our financing strategy. 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 they 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 quarterly report on Form 10-Q for the first quarter ended July 31, 2011, which will be filed later today, and our annual report on Form 10-K for the fiscal year ended April 30, 2010, which was filed July 14, 2011.
Investors should not rely on forward-looking statements because they are subject to a variety of risks, uncertainties and other factors that could cause actual results to differ materially from our expectations, and we expressly do not undertake any duty to update forward-looking statements, whether as a result of new information, future events or otherwise. I'll now turn the call over to Steve.
Thanks, Amy. I thank all of you for participating in today's quarterly conference call.
This quarter, we've had continued progress in advancing our clinical programs, building from important clinical data and regulatory meeting milestones later this year and throughout 2012. One of the key highlights this quarter was clinical data from our Phase II trial treating cancer patients with bavituximab and Cotara. What's particularly encouraging to the team here at Peregrine is that each data point continues to provide positive signs of safety and activity, not only for each trial, but for the programs as a whole. Positive tumor response rates, progression-free survival, and most recently, median overall survival. Taken together, these results are further convincing us that these are active developable drugs which have the potential to make a real difference in the lives of the patients we are treating.
Beginning with bavituximab, we have recently reported very promising median overall survival data from our single-arm Phase IIa trials, one in front-line non-small cell lung cancer and one in locally advanced or metastatic breast cancer. Joe will be reviewing specific details of these later in the call, but let me say that we are all excited to see that the promising early data from these trials have correlated nicely with the most recent survival data for our patients.
It's worth noting that we continue to monitor survival from a third Phase IIa single-arm trial in which we treated advanced breast cancer patients with bavituximab in combination with carboplatin and paclitaxel. Earlier data from this trial were promising and we are pleased that the patients from this trial, which was completed around the time of our other breast cancer study, haven't yet reached median overall survival. While breast cancer is a very large yet fragmented clinical indication, these compelling data motivate us to look at ways to move forward with future bavituximab trials for these patients. One of these trials is already underway as an IST. So far, 8 of the 9 data points from these 3 prior trials have been very encouraging with one data point still yet to be reported, encouraging to say the least. Our focus is now to advance our 4 ongoing randomized Phase II trials for bavituximab in cancer and HCV, while continuing to find ways to advance the multitude of potential indications for bavituximab. Joe will discuss these important clinical developments later on our call.
It's important to remember that PS-targeting technology platform has many potential uses and that researchers continue to explore bavituximab and our other PS-targeting antibodies therapeutic and diagnostic potential. And we look forward to pursuing the full potential of the technology, both internally and with our development partners.
Before turning the call over to Rob, I'd like to quickly review our upcoming clinical data and regulatory milestones. We recently completed patient enrollment in our randomized Phase II trial for bavituximab in front-line non-small cell lung cancer, keeping us on track to report interim data by the end of this year and top line response data from all patients in the first quarter of next year. Our second line non-small cell lung cancer trial is expected to complete enrollment of 120 patients early in the fourth quarter, putting us on track for primary endpoint tumor response data unblinded in the first half of next year.
For our randomized Phase II pancreatic trial, we continue to enroll patients and expect data from that study again in 2012. And for our randomized Phase II HCV trial, we are nearing completion of enrollments with the 12-week EVR primary endpoint data expected by the end of this year or early next year.
For Cotara, we continue to plan for a meeting with the FDA in the fourth quarter of this year, where our goal is to walk away with a Phase III registrational trial design for this unique approach in treating brain cancer patients.
With that, I'll turn the call over to Rob. Rob?
Thanks, Steve. I'd like to review our overall regulatory strategy before discussing our specific plans for Cotara. We believe both bavituximab and Cotara are active drugs, and we have developed a regulatory strategy to increase the probability of successfully making it through with development and regulatory process.
Our strategy is really focused on addressing indications representing high unmet medical needs, which offer a fast path to regulatory approval. Bavituximab is an antibody that has broad therapeutic potential. We are focusing on second line non-small cell lung cancer as a first potentially approvable indication. Our ongoing Phase II trial is a randomized double-blinded placebo-controlled trial in 120 patients. It was designed to have all of the hallmarks of a small registrational study that could be part of a registrational package of our data support Phase III development. We're also conducting a front-line non-small cell cancer trial, which is designed to replicate and confirm the promising data from our prior Phase II single-arm trial. In addition to confirming the prior data in a randomized trial setting, the purpose of this open label trial is to use the interim data to help determine our investments, which we would need to make shortly in preparing for future Phase III development. And if the interim data are consistent with our prior positive data, we will certainly move ahead with Phase III trials and preparations.
As we saw over the last couple of weeks with the most recently approved therapy for non-small cell lung cancer drugs, can in fact receive accelerated approval, based on objective response rate data generated from single-arm studies, and we're very eager to assess bavituximab's potential in our ongoing trials.
Switching to Cotara, we are making progress preparing for an end of Phase II meeting with the FDA in the fourth quarter of this year. A novel single-administration approach to treating deadly recurrent GBM, which has shown promising 8.8-month median overall survival, really helps the stage for what we expect will be a productive meeting with the FDA. Our goal remains to determine the optimum registration path to support registration of Cotara.
What do we intend to walk away with following this meeting? First, we need to negotiate a reasonably sized trial that we or with a potential partner are able to enroll within a 24-month period. We expect the trial will be multicenter and international, with sites in both the U.S., Europe and India. Following this FDA meeting, we expect that this information will inform our development path and we will communicate this information as it transpires. I'll now turn the call over to Joe.
Thanks, Rob. Now let me provide an update on the bavituximab clinical program. First, I'd like to say how encouraged we are to see the recent survival data coming out of our prior bavituximab signal-seeking Phase II trials in lung and breast cancers. The promising initial data from those trials, that is the consistently positive tumor response and PFS results, supported that bavituximab has antitumor activity. That fuels enthusiasm to advance the development of this compound. But the ultimate goal of developing new cancer treatment is to prolong patient survival. And now, we are starting to see the promising overall survival and we are eager to confirm these prior results and the current randomized Phase II trials.
Before talking about our 4 ongoing randomized Phase II trials for bavituximab, I'd like to quickly summarize the most recent data reported from the single arm Phase II study. In the front-line non-small cell lung cancer trial, treating patients with bavituximab in combination with carboplatin and paclitaxel, we recently reported a median survival of 12.4 months, which is 20% longer than that the 10.3 months reported in patients treated with carboplatin and paclitaxel alone in a published study which we used a historical benchmark. It's important to point out that the data from this single-arm study was the basis for our ongoing randomized Phase II front-line lung cancer trial that recently completed patient enrollment. And just a few weeks ago, we reached a median overall survival of 20.7 months from the second prior signal-seeking trial, this one in advanced breast cancer patients treated with bavituximab and docetaxel. This was nearly twice the reported survival of 11.4 months for patients treated with docetaxel alone to the studies cited in the docetaxel package insert.
Now breast cancer is certainly a significant opportunity for an agent like bavituximab, and we've been asked what our development plans are in this indication in light of the encouraging survival data. For near term, we have an ongoing investigator-sponsored trial in HER2 negative metastatic breast cancer patients. And in the future, we will continue to evaluate development options for breast cancer as our resources permit. We have one more prior signal-seeking Phase II trial which has not yet reached median overall survival. This trial treated front-line advanced breast cancer patients with bavituximab in combination with carboplatin and paclitaxel. We are continuing to follow these patients and will report on survival when the median has been reached.
Turning to our 4 ongoing company-sponsored trials, we recently completed enrollment of 86 patients in our randomized Phase II trials in front-line non-small cell lung cancer. This was an important milestone for this program, as we can now shift our focus to data collection and analysis. We're planning to report interim data by the end of this year and estimate top line tumor response data from all 86 patients will be available in the first quarter of next year. Meanwhile, we will continue to monitor secondary endpoints, such as progression-free survival and overall survival.
We're also getting closer to completing patient enrollment in our second line non-small cell lung cancer trial, which is a randomized double-blinded, placebo-controlled trial in 120 patients. We're on track to complete enrollment early in the fourth quarter, which should result in having unblinded data in the first half of next year. This trial currently has over 50 open clinical sites actively recruiting and treating patients and we are eager to assess the data once we are able to unblind.
Next, I'd like to quickly provide an update on our 2 additional company-sponsored trials. We're continuing to advance our randomized Phase II trial in pancreatic cancer. This is a very difficult to treat and lethal disease, and it's challenging to identify and screen patients as their expected survival is unfortunately less than 6 months from time of diagnosis. We currently have about 15 actively enrolling sites and continue to add more sites in the U.S. and internationally to complete enrollment of the 70 patients and report data next year.
Shifting to the hepatitis C trial. We're on track to complete enrollment of 66 treatment naive genotype-1 patients in this randomized Phase II trial by the end of this month, and report 12-week EVR data by the end of this year or early next year.
Before turning the call over to Paul, I'd like to just reiterate how encouraged we are about the collective set of data from our earlier bavituximab trials. In a total of 8 completed early phase trials comprising over 250 patients with cancer, HCV, bavituximab has consistently shown promising data pointing to its broad therapeutic potential. With bavituximab's unique target and mechanism of action, we're excited to be developing this first in class monoclonal antibody for the treatment of cancer and HCV. And we look forward to providing important data updates from our randomized bavituximab Phase II trials starting toward the end of this year and into 2012.
I'd like to now turn the call over to Paul.
Thanks, Joe. Since our financial results for the first quarter of fiscal year 2012 can be found in our press release, I'd like to spend the next few moments reviewing our financial goals and strategies.
First, I'd like to emphasize that we are closely managing our business, our cash position and our sources of capital as we advance our later-stage clinical programs. Our stated goal over the last several quarters has been to match our investments in research and development with the various sources of capital and we can continue to hit the target.
During the quarter, we reported $5.4 million in contract manufacturing revenue from our wholly owned subsidiary, Avid. This represents one of our important sources of capital. This increase in revenue was primarily due to an increase in the number of manufacturing runs completed and shipped during the quarter. As we have seen in past quarters, it is normal for Avid's revenue to fluctuate from quarter to quarter based on the level and timing of services and most importantly, the timing of lot release. With the first quarter's increased revenue and Avid's expected services scheduled for the remainder of this fiscal year, we are increasing our revenue guidance for the fiscal year from $8.5 million to a range of $10 million to $12 million. And while Avid's goal is to continue to provide the highest level of services to its third-party clients, having Avid's built-in manufacturing capabilities allows us to be prepared for potential later-stage clinical trials and commercial launch by both bavituximab and Cotara.
In addition to the revenues generated from Avid, we also look to the capital markets. And although the overall market conditions over the last several months have not been favorable, we were able to raise $3.7 million during the quarter under our cost-effective and warrant-free financing vehicle called aftermarket or ATM program. And since the end of the quarter, we raised an additional $9 million in gross proceeds, including $7 million placed to 3 institutional investors and a warrant-free registered direct offering, further strengthening our balance sheet as we fund our investments in our advancing pipelines. Also, this transaction increased our institutional ownership from 20% to approximately 26% and we will continue to target new institutions as we approach our upcoming milestones.
We have just completed enrollment in the front-line lung cancer study and we are close to completing enrollment in the second line lung cancer study. These enrollment goals set the stage for multiple clinical data points expected over the coming months, and these are the inflection points that many investors and potential partners have been waiting for since we started the ongoing lung cancer studies mid last year.
Before opening the call to questions, it's important to remind everyone that our later-stage clinical assets, bavituximab and Cotara, remain mostly unencumbered and represent another source of capital that we expect to help fund our development efforts. As we have randomized data for bavituximab and a registration path for Cotara, we believe a great amount of value may be added to these 2 programs as they become Phase III-ready programs.
We look forward to keeping you updated on our progress, and we'll now open the call up for your questions. Operator?
[Operator Instructions] And our first question comes from Charles Duncan with JMP Securities.
Jason Butler - JMP Securities LLC
This is Jason in for Charles. I guess, my question on the ongoing lung cancer trials, could you maybe talk a little bit about the details the patient population there in terms of histology, smoking status, previous therapies for the second line trial?
Sure. I think most of this information is available on clinicaltrials.gov, but in short, the patients are non-small cell lung cancer patients which have the squamous cell histologies excluded. And these are patients who have not received more than one prior therapy. Most therapies are allowed, of course, prior docetaxel would be excluded. Other than that, we don't have significant restrictions, for example, smoking status or other [indiscernible] bavituximab pathway or mechanism is not expected to be different.
Jason Butler - JMP Securities LLC
Okay, so you're not focusing enrollment on a specific type of smoking status? What you're looking for is general or a representative of the population?
[Operator Instructions] And next in line, we have George Zavoico with MLV.
George Zavoico - McNicoll, Lewis & Vlak LLC
My question revolves more about, I think what's going on this weekend or over this weekend. You've got some posters at an imaging conference, and this is something that, I guess, your associate sort of talked about at ACR or ASCO this year. It seems to be that this technology or this application of your PS-targeting antibody is progressing fairly well. Could you talk a little bit about what your plans are for that application are?
Sure, yes. Yes, I mean, I think that, as I mentioned in my prepared remarks, there's a lot of utility for the PS-targeting platform, and I think it includes imaging diagnostics, as well as potentially antibody drug conjugates. So this is just a wealth of new programs that can sprout from the PS-targeting platform. In particular, what you're talking about this weekend is an extension of basically the data we did present at AACR this year, where we had some -- actually some of our internal group that presented some data that actually won a nice award at AACR, really demonstrating that you can actually utilize PS as a marker basically of the effectiveness of chemotherapy. So the concept being that you give chemotherapy, that regulates the target. So if you scan a patient or in a preclinical models, animals with tumors, then you can really see a difference pretherapy and then post-therapy. And I think that we do see a very nice utility here. I view it in 3 different ways and we are very interested in moving this technology toward the clinic. And it's getting to the point where we really are in a position where we can move it in that direction. I think our goals for the imaging agents themselves are -- I'm going to show you this further proof of principle showing that PS is a very specific target and that it can be a nice marker of solid tumors, as well as potentially metastatic disease. The second being the -- well, this utility of modulating or following the effectiveness of therapy. You can imagine the use there would be something along the lines of you would give a scan before patients beginning chemotherapy regimen. You start to do scans as they receive their courses of therapy, and look for the effectiveness, with the idea being that you can potentially stop therapy that wasn't being effective, and move to hopefully another chemotherapy regimen that might be more effective in those patients. And then the third is of course, as a potentially companion diagnostic and which you may be able to actually select patients who are more PS-positive or who might, in some way, do better on therapy. And that's the other revenue we're pursuing. But I think we're all really excited about the technology. I think that the data speaks for itself. It's pretty phenomenal, the types of images we get, and we're really looking forward to seeing this move from the preclinical models to right into patients.
George Zavoico - McNicoll, Lewis & Vlak LLC
More on that in the future, with regards to the more PS-positive patients being able to select out that patient population prospectively, there's really no way of doing that now, is there?
Yes. I mean, right now, it's sort of more of an idea than it is something where we've got really strong proof of principle. I think that what you see is even if you did have slightly more positive PS-wise patients, when you give chemotherapy, it really kind of even things out amongst the tumors that you've looked at and that it really causes up regulation of PS. And now, really basically all the tumors become very positive for PS. So at this point, it's more of a theoretical idea, but I think it's one of the things that, in fact, it's surprising if we see this pop up in some of our ISTs, where we actually look at the scans of patients and then follow them through the therapy and then see how they do on treatment. And I think you just have to empirically look at that.
George Zavoico - McNicoll, Lewis & Vlak LLC
Okay, that's pretty cool. One quick follow-on with -- regarding Cotara and the possible protocol designed for that. Rob, I think you said with -- you're looking for 24-month period for enrollment? Is that -- did I hear that right?
Yes. George, we're -- I think one of the important things with Cotara is that we're able to design a trial and work with FDA that we can actually execute. And as you know, these patients are difficult to find and to really conduct a trial and get the results in a reasonable timeframe, our thinking is that we would like to really focus on being able to do that within a 24-month period. So that's really fundamental in our thinking with respect to the number of patients that we'll ultimately try and work into this kind of trial.
Yes, and maybe just to expand on that a little bit. I think that obviously, we're very much looking forward to this interaction with FDA and then coming away with this with -- we really have programmed, at the end of this process, we'll end up with a registration pathway that's, as you just talked about, that's executable within a defined timeframe. Secondly, that's a reasonably sized trial, which, of course, then directly correlates with the overall cost of the trial. And really, I think that's what partners are most interested in. What does that pathway look like? What is the sort of the total cost of that pathway? And then how does that match up with the expected market of the drug? So all those -- there's a lot of balls in the air there, obviously. And we want to make sure that at the end of this process, we really come away with something we can be happy with and execute.
George Zavoico - McNicoll, Lewis & Vlak LLC
Yes, I kept thinking a step further, with the 24 -- if it's going to be a 24-month period of enrollment, and you got a median overall survival of -- in the years' timeframe to make it a reasonable trial, it can be, in terms of cost and in terms of total time of execution before you get to read out where you may or may not be able to go to the FDA for a registration package. I mean, median overall survival really can't be a – primary endpoint can it? Unless it's going to be a really, really long trial.
Yes, well, I think it's important to -- with any of these trials, we're talking about the enrollment timeframe of 2 years. I mean, that's obviously from the long side of what we would hope we could accomplish. But again, I think it's all driven by the trials than on itself. Again, median overall survival expected for this patient population around 6 months if we're able to, again, approach 9 months as we had in our earlier study. Then clearly, there's a window once you complete patient enrollment before you have the final results from the trial. Yes. Unfortunately for the patients, it's a pretty rapidly progressing disease. And that's -- we're hoping to move that bar a little bit longer and make the trials more effective.
And I think, just to jump in, in our discussions, median overall survival, while you're right, it is somewhat lengthy. Nevertheless, Steve said the survival's typically only 9 months. So it's actually quite doable. And the registration standard by which we're going to be able to have the program that I think will be acceptable to both the agency and partners to work with us.
And next on the line, we have Roger Adams, a private investor.
My question continues the Cotara discussion, but regards to the possible department partner. One of the hopes investors have is that Cotara license in 2012 will relieve some of the downward pressure on the stock price from constant ATM selling. I'm wondering if you could give us some guidance on the range of values that might be received in upfront licensing fees from a regional Cotara license? And I understand my -- there are a number of assumptions, so I'm assuming you get favorable outcome from the FDA meeting and that the license is typical in terms of industry norms or royalty rate and that it's a regional license, which I know you're hoping to achieve, like Western Europe or Pacific Rim. But with those assumptions, can -- is it possible for you to, based on -- I'm not asking you to predict what the outcome of your negotiations will be, but just based on industry norms you've seen in other deals, some guidance as to the range of upfront values that might be realized from a regional license?
Yes, I mean, I think it's a very complex question you're asking. I think it's impossible to just answer that there's a kind of like one-size-fits-all because that's just not the case. I think our goal, if you look at this from a partnering standpoint is, is really to get value from the program and to use that as a future value driver as well. So simply, moving Cotara off the plate is not the goal here. The goal is to see Cotara move forward to generate revenues eventually that really make a significant difference to the company. And as you said, our goal is eventually, to have marketed products. I think it's how we're building our manufacturing thinking internally with the commercial capabilities at Avid. So I mean, I think there's no way to say where we're going to get x number of dollars up front or even that we would have that sort of a mindset. I think it's going to really depend on the clinical trial design, the overall cost of that trial, executing that. Clearly, the goal of partnering will be to reduce that burden or eliminate that burden from the company and to see the technology move forward. And I think those will remain our primarily goals for the program. I mean, that's just the way to build value for the shareholders and to achieve the maximum value we can from the program because obviously we put a lot of effort into it. And we're very happy with the results, we're very happy that -- see the long-term survivals in the trials and getting this product to the market is really the primarily goal. And of course, for bavituximab, it may be a similar situation, although it's a little bit more dynamic because of the broad potential of bavituximab in so many different solid tumor indications. Clearly ex-U.S. partnering there, we think has some significant potential when it comes to what that can mean for the company. So the goal there is a little bit different in that we do want to utilize ex-U.S. partnering to really allow us to drive U.S. developments from a financial standpoint. So I think that its each program has its own possibility, so thank you again for the HCV program. It's really, I think, if we have positive data and it validates the potential of bavituximab as an immunotherapy in HCV, then that's a program that we might want to just outright license to someone because it's a specialty area, it's an ever-evolving area. And it's part of the type of indication where a partner wants to customize it for their particular portfolio products in that area. So -- but partnering discussions are ongoing. A lot of interested parties actually looked at bavituximab and Cotara. So that's a matter of patent meeting with the FDA getting the trial design and getting the clinical results from the rest of the bavituximab studies. And then we'll see where that takes us.
Well, that's a very a complete answer and it's interesting to hear that from a financial point of view, HCV or bavituximab may end up being more of an early shot in the arm for the company than Cotara. I gather that's the importance of what you're saying?
Yes. I mean, I look at this, what our opportunities for success for residing those 3 Phase II programs and they are programs in addition to Avid. I mean, I think Avid is another area of success for the company and we want to continue to achieve its full potential. So well, we're pushing on all these fronts and we think good things could happen by being diligent, generating more data and just taking care of business.
At this time, I'd like to turn the call over to Steve King, CEO, for any closing remark.
Well, I just like to end up by, again, thanking everyone for participating in today's quarterly conference call. I'd also like to thank our patients who are enrolled in our studies and are receiving treatment that will really be helpful and make a difference in their lives. And we certainly look forward to the next opportunity to update you on the company activities. With that, thank you very much.
Ladies and gentlemen, thank you for participating in today's conference. This concludes the program. You may all disconnect. Everyone, have a great day.
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