Sunday, March 13, 2016 6:25:18 PM
3-9-16 Qtly CC-Transcript, PR(Fins/Devs Q3FY16/qe1-31-16), updated Avid Revenues History Table By Quarter…
=> Total Revs May06-Jan16: $154.8mm/Avid + $24.1mm/Govt + $2.4mm/Lic. = $181.4mm. Cash at 1-31-16: $67.5mm
As of Mar. 8 2016, there were 233,738,426 shares outstanding.
This large post has 3 sections:
I. 3-9-16 Q3/FY16 Qtly. Earnings Conf. Call TRANSCRIPT (q/e 1-31-16)
II. 3-9-16 PPHM Press Release: Q3/FY16 Earnings & Developments
III. Updated Table of Avid Revenues By Quarter (May’06-Current)
…Recall: Peregrine’s FY runs May-Apr, so FY’16 = May’15-Apr’16.
((( Orig. transcript from SeekingAlpha.com [ http://tinyurl.com/hwm56ah ], with numerous corrections made. )))
Link to webcast replay: http://ir.peregrineinc.com/events.cfm => http://edge.media-server.com/m/p/iirfkpej
FULL TRANSCRIPT…
3-9-2016 FY’16/Q3 Earnings Conf. Call (q/e 1-31-16)
WELCOME & FWD-LOOKING STATEMENTS: Tim Brons, Vida Strategic Partners (IR) http://www.peregrineinc.com
Speakers: Steve King, Joe Shan, Stephen Worsley, Paul Lytle; Q&A session.
CEO STEVE KING – OPENING COMMENTS:
Thanks to all of you who have dialed in, and to all of you who are participating via webcast today. It is certainly been an interesting time at Peregrine since our last regularly scheduled conference call. On the downside was the recent announced discontinuation of our Phase III SUNRISE trial. On the upside was the announcement that we had completed formal commissioning of our new biomanufacturing facility and that the manufacturing in this facility was well underway, giving us a great new revenue source from which to continue growing the business, which this FY (FY16: May'15-Apr'16) will easily reach an all-time revenue high.
So, where do we go from here? First, we continue growing our thriving mfg. business, where we see the opportunity to grow even beyond the new mfg. facility. Demand for services is at an all-time high and, importantly, we are seeing significant opportunities for late-stage clinical and commercial production that can yield a solid base for future growth. So on this side of our business, it is business as usual, supporting our clients with their development and commercial production needs.
On the development side, it is a transition time for our bavituximab program. While the results of the interim analysis from the SUNRISE study are unfortunate, and it is a setback for our chemotherapy combinations with bavituximab, it is by no means the end of the program. For starters, we have not yet completed patient follow-up in the SUNRISE study, with the goal of learning as much as we possibly can from the trial. Important to note is that patients that enrolled in the study and are still active are continuing to receive chemotherapy and those patients that were on the bavituximab arm have the option to continue receiving bavituximab, and some have already expressed an interest in doing so. And, we will be continuing follow-up on these patients as well as survival follow-up of patients that have already exited the study. At this point, our goal for the study is to obtain data from the trial that can potentially be critical in how we move the chemotherapy combination program forward and even information that can help guide the overall program: which patients did particularly well in the study? what were their characteristics? - these are just a couple of examples of the many types of questions that we want to attempt to address as we wind down the SUNRISE trial, so that we can tailor patient selection in future studies. As we generate this data, we will be able to share it at the appropriate time in the future. As for advancing the program, we are as excited & confident as ever about the immuno-oncology combination potential of bavituximab. As you may recall, this was already the counterpart to the chemotherapy combinations based on a completely different mechanistic synergy; namely, to start an immune response in patients lacking a good immune response, and then prolong the immune response by blocking the PD-1/PD-L1 pathway that can counteract a strong immune response in patients. This combination hypothesis is still completely intact. We have generated a significant amount of translational & preclinical data demonstrating that bavituximab has the potential to enhance the activity of checkpoint inhibitors, and our goal for the coming year is to bring many of these concepts into the clinic and to demonstrate the potential of bavi in this important area of cancer therapy.
With our I-O combination program having been underway for sometime, long before the SUNRISE results, we have formed collaborations with some of the leading I-O players in the world: a collaboration with AstraZeneca to study bavi with their PD-L1 inhibitor durvalumab, a collaboration with researchers at Memorial Sloan Kettering Cancer Center to study novel combinations of bavituximab with I-O agents, a collaboration with National Comprehensive Cancer Network (NCCN) to run multiple clinical studies focused on I-O combinations at some of the 26 leading cancer centers in the U.S. that are part of the network, with significant involvements, as part of the program, from KOL's at those institutions, all in addition to our long time collaborations at the Univ. of Texas SW Med. Ctr. that will continue to be active in pushing forward I-O combinations. The main difference with the SUNRISE results in hand is that the I-O combination program has become our major area of clinical focus and, as such, we are working with all of our collaborators to redefine the program in order to have a cohesive & comprehensive strategy that ties together the efforts of all of our collaborators and will allow us to rapidly advance the program. The strategy will involve studies designed to answer specific questions about particular patient populations where we already have evidence that bavi may have the biggest impact, allowing us to more quickly generate data that we can build on as we advance the program. These planning efforts are well underway as we speak, and we look forward to updating you as they are implemented into the clinic. I will now turn the call over to Joe Shan, VP, Clinical & Regulatory.
JOE SHAN (VP/Clin.&Reg. Affairs) – CLINICAL TRIALS:
I’d like to start by speaking about our Phase III SUNRISE trial, which we discontinued in late February [2-25-16: http://tinyurl.com/jbg48vs ]. The decision to stop the trial was based on the recommendation on the study’s Independent Data Monitoring Committee (IDMC), following a pre-specified interim analysis. While the interim analysis showed that the bavituximab combination group was performing as expected according to the original trial assumptions in terms of overall survival, it also demonstrated that the docetaxel group had dramatically outperformed OS expectations based on the original trial assumptions and as compared to recently published studies. Nevertheless, enrollment has been stopped and we are now in the process of winding down the trial. As part of this process, patients who are still receiving study treatment are given the option completing their chemotherapy, and for those patients assigned to the bavituximab arm, they continue to receive bavituximab if the investigator believes this is in the patient’s best interest. Because I-O agents can elicit delayed responses and prolonged survival, we are continuing to follow such patients to evaluate their outcomes. Such information will certainly be valuable and help us form future decisions for the company. As we continue to collect and clean the remaining data, we are also conducting a thorough evaluation of the already available clinical data. While we perform these analyses, we’ve put a hold on the trials that combine bavituximab with chemotherapy until we have a clearer understanding of SUNRISE study results. Specifically, we have put our recently initiated Phase II/III breast cancer trial on hold, as well as the start-up activities for a Phase II early-stage breast cancer trial. It is our plan to publish our findings from SUNRISE when it is completed and we will provide an update on this process next quarter.
Looking ahead, our priority is to generate clinical evidence of bavituximab’s ability to improve patient outcomes when combined with immuno-oncology agents. To this end, AstraZeneca and we are currently evaluating a trial design for the 2 previously announced clinical trial combining bavituximab with AZ’s PD-L1 inhibitor durvalumab. In light of the recent development in the SUNRISE trial, our companies are currently working together to identify the optimal path forward for demonstrating potential mechanistic synergies between bavituximab & durvalumab in different patient populations. We are particularly interested in combing bavituximab with checkpoint inhibitors because it has been observed that checkpoint inhibitors are most effective when there is a pre-existing T-Cell response in tumors. Importantly, we have pre-clinical evidence that bavituximab-like antibodies trigger CD+ T-Cell responses which can be prolonged by the addition of PD-1 checkpoint inhibitors. Another important observation we’ve recently made is that our PS signaling pathway inhibitors demonstrate multiple signs of immune activation in low or negative PD-L1 expressing tumors. We believe that this holds great potential to increase the number of patients able to respond to checkpoint therapies. Based on these observations, we believe that by combining these 2 projects the potential exists for a more complete
& lasting anti-tumor immune response.
Lastly, I’d like to comment on our newest collaboration with the NCCN. The goal of this partnership is to build upon the company’s clinical dev. program of bavituximab in combination with I-O agents for the treatment of a range of tumors. NCCN is a not-for-profit, alliance of 26 of the world’s leading cancer centers dedicated to improving the quality, effectiveness, and efficiency of cancer care. Through this collaboration, Peregrine will have an opportunity to fund multiple investigator initiated clinical & correlative studies with bavituximab in a range of cancers at the NCCN member institutions and their affiliate community hospitals. We believe this relationship will prove to be highly valuable, as it will allow Peregrine to expand and augment our bavituximab clinical dev. program through experienced investigators & world-class institutions. It would be impossible for a company of our size & stage to gain access to incredible institutions and clinical thought leaders otherwise. This collaboration remains quite new, but we look forward to reporting our progress in the not too distant future. This concludes my comments today. I will now turn the call over to Steve Worsley to give an overview of the business dev. and mfg. activities.
STEPHEN WORSLEY (VP/Business Dev.):
As Joe provided an update on our collaborations with AstraZeneca and the NCCN, I’d like to provide an update on Peregrine’s other I-O-focused collaboration with the Memorial Sloan Kettering Cancer Center. The goal of this partnership is to evaluate combinations of bavituximab with other checkpoint inhibitors & immune stimulatory agents for the purpose of developing new and increasingly effective anti-cancer treatments. This work is advancing well. To-date, we have seen initial signs of activity with new combinations with bavituximab and other treatment modalities, such as checkpoint blockers, T-Cell agonists, and radiation. Our plan is to spend the next year investigating these possible combination potentials. We are also renewing the contract for next year as we’ve seen exciting results thus far.
I’d now like to discuss our biomanufacturing business, Avid Bioservices, as we announced earlier this week, our new state-of-the-art commercial biomanufacturing suite, which we call the Myford facility, has been formally commissioned [3-7-16: http://tinyurl.com/za2j9mt ]. As part of the commissioning process, all relevant regulatory agencies have been notified and GMP production is currently underway. The new facility, which is being operated by Avid Bioservices, will more than double the company’s prior mfg. capacity. The 40,000sf biomanufacturing facility, which is located adjacent to the company’s current campus in Orange County, is outfitted with cutting-edge, single-use equipment to accommodate a fully disposable biomanufacturing process for late Phase III clinical & commercial production of biologics. Despite its world-class design, the Myford facility was completed for a fraction of the cost of building comparable facilities, something of which we are quite proud. The suite is capable of operating reactors as large as 2000 liters in volume. GMP material produced in new facility can be used either in clinical trials or for commercial sales once Peregrine or its partners make the appropriate regulatory filings. Demand for this new production capacity is high, and we already have locked commitments extending well into 2017. As this demand continues to grow, it leads us to consider options for potentially adding more production capacity in the near future. We are currently evaluating a number of opportunities to meet this demand and are extremely optimistic about the growth of this business. We believe that the Avid business will continue to be a tremendous source of new business for Peregrine, and it is our goal to pursue every opportunity to build demand and expand capacity. That concludes my comments. I will now turn the call over to CFO Paul Lytle who will discuss the company’s financial performance, including addl. details regarding our Avid Bioservices business.
CFO Paul Lytle:
We are pleased to report that we continue to see significant growth in our contract mfg. business. Last qtr, we raised our FY'16 [May'15-Apr'16] revenue guidance from $30-35mm to $35-40mm and today, we believe we can exceed this guidance and top $40mm in contract mfg. revenues for the full FY'16. This represents revenue growth of ~50% over the prior FY, in addition to the continued growth we’ve seen over the last several years. I would also like to point out that our mfg. revenue for the full FY'16 will be solely derived from our existing mfg. facilities and our newly commissioned facility has the potential to generate an addl. $40mm in mfg. revenue.
Turning to the current qtr, we generated contract mfg. revenue of $6.6mm, representing an 18% increase compared to the same prior year qtr, and YTD we recorded mfg. revenue of $25.6mm or a 47% increase compared to the same prior year period. Our outlook for this business remains very positive, with our customers continuing to book available production capacity. Our revenue backlog has grown from $49mm reported in the last qtr to over $58mm as of Feb. 1, 2016, the beginning of our Q4. Looking ahead, we expect Avid Bioservices to continue to play a critical role in our business. Avid continues to generate non-diluted income that significantly reduces the amount of capital we need to raise by other means. For this reason, growing the Avid business will remain a high priority for the company.
Now turning to expenses, R&D expenses for the qtr increased primarily due to the increased mfg. costs associated with bavituximab, combined with increased cost associated with the previously planned Phase II trials in breast cancer & lung cancer, while G&A expenses remained relatively flat qtr-over-qtr. A more detailed analysis of our statement of operations is included in our Form 10-Q that will be filed later today [10-Q: http://tinyurl.com/hdgto9y ]. This concludes my financial overview, and I will now turn the call back over to Steve to discuss some important upcoming milestones.
CEO STEVE KING – MILESTONES:
As you’ve heard from our team today, Peregrine remains a strong company with a valuable clinical asset and a rapidly growing biomanufacturing business. The important work of developing bavituximab as an anti-cancer therapeutic continues. We believe our relationships with AstraZeneca, Memorial Sloan Kettering, UT Southwestern, and with the NCCN will be invaluable as we establish & execute our overall strategy for advancing the bavituximab I-O combination plans in a range of cancers. And, our Avid Bioservices business continues to outpace our initial projections providing a steady growing revenue stream. The Avid business grew 20% in FY'15 to $26.7mm in revenue, and is expected to exceed $40mm in FY'16, with our new “Myford” facility now online to help drive further growth in FY'17. It is fair to say that Avid has experienced significant success, and we are evaluating a number of opportunities to continue to expand this important business. This concludes our prepared remarks and we would now like to open the line for questions.
Q&A: [19:10 mark]
1. Joe Pantginis – Roth Capital Partners: [ http://www.roth.com & https://roth2.bluematrix.com/docs/pdf/BLUE.pdf ]
JP: ”With regard to the overall operations of Peregrine, you are obviously looking at increased revenue from Avid, so with that in mind, how are you looking to fund the company going forward with regard to the Avid revenues, your outstanding ATM, and is there a potential for restructuring following the SUNRISE news?”
Paul Lytle: That’s a good question, Joe. We are very committed to maintaining a solid cash position to run our business. We’ve always said in the past that our goal is to maintain a balanced financial approach, so we like to complement our cash position with the revenues that are coming in for Avid. We can utilize potential offerings through the equity markets if we need to and then obviously we're looking at other opportunities. Different collaborations, different revenue streams, and growing the Avid business I think will be imperative for the company as we advance our business. So, again we are looking at maintaining and sustaining a very operational business here and to support our customers.
JP: ”And with regard to the size of the business and any potential restructuring?”
Paul Lytle: Currently, we have no restructuring in terms of the size of the business. Our goal is to continue to grow the business and we have plans to do that.
JP: ”OK, and switching to the I-O combination program, Steve, you made a comment about how the program is going to be redefined now, can you talk a little more about what that means; specifically, I know you had some certain views about what the AZ protocols might have looked like. Have those changed and what have your discussions been with AstraZeneca since the SUNRISE news?
Steve King: One of the things we’ve done, which is prudent, is, based on the SUNRISE data and the fact that we really need to understand what happened in that study - why did the control arm way outperform what we expected going into it. As Joe mentioned in his remarks, we have put on hold a couple of the clinical studies that would have been starting otherwise. This does two things – one, it gives us a chance to give more data from the SUNRISE trial and to make sense out of it; the 2nd is that it also controls expenditures in those areas and those were a couple of significant expenditures for the coming year. In addition, our overall strategy, and this pertains to both questions, is really to focus our clinical dev. efforts on studies that can yield, #1, quick data or as quick as possible, but also smaller studies that really allow us to build on early successes and then to grow our knowledge base as we expand into larger trials. It’s a huge benefit to be able to do that based on the tale, if you will, of good clinical data. Yes, we’ve entered into discussions with AstraZeneca, we are having discussions with NCCN, with our other collaborators at Sloan Kettering & UT Southwestern about, how do we put together a cohesive program, because we don’t want a bunch of individual activities that don’t fit well together, what we want is a program that allows us to answer critical questions in multiple indications simultaneously and then to build on solid clinical data, looking at patient populations such as PD-L1 negative, where we have already shown in some of our translational work and pre-clinical studies that may be where we can have a big impact, so we’ll be able to look at that in a clinical setting. But, taken overall, it also helps to control the burn rate until we can generate good clinical data that’s positive and then that of course should help both on the partnering as well as the funding fronts. So, we're taking this very step-wise, and continuing to grow the Avid business just makes good sense, because that really helps cover the overall business operations.
JP: ”Would you say that there has been no change to the tenor of your discussions with AstraZeneca?”
Steve King: What I would say is that the tenor of discussions has changed just because, what now makes the most sense, because the rationale for running the Phase II study in NSCLC was little bit different. It was really meant to augment a positive clinical study in chemo combination, and so they then had coverage for both the I-O combination as well as the chemotherapy combinations. I think now the goal has changed somewhat, and I think for both of us into, how do we now build on good clinical data and find those patient populations that are most likely to respond. So, it’s sparked of a lot of a new conversation, all which I think is very positive and I think also which will allow us to not just run studies with AZ, but also to incorporate what we are doing with NCCN, Sloan Kettering, UTSW into that overall plan which benefits both Peregrine & AstraZeneca and everyone involved.
JP: ”You mentioned re: SUNRISE that patients will be able to, if they request, remain on bavi. Do you have a sense of how many patients that might be, and the potential cost associated with it?”
Steve King: Yes, I think the potential cost will be relatively minimal just because, obviously, it’s going to be a portion of the patients that would be going forward with that, but it was already captured in the initial intent of running the study. But, the benefit far outweighs any expenditures associated with those infusions, because #1 we only have the drug, #2, it allows patients to stay on and as the data matures, our goal is still to get as much data from this study as possible, which includes which patient populations maybe doing better, is there a survival tale – a lot of questions we still want to answer and the more we are able to keep patients on the study, keep them going through, I think the more likely we are to be able to get some really nice data that we can again, really employ as we continue to advance the program.
2. Thomas Yip (FBR & Co.): http://www.fbr.com
TY: ”Re: your ongoing discussions with AstraZeneca, you mentioned it involves finalizing the design of 2 trials. I am just wondering whether it’s still a Phase II trial for NSCLC and then another trial for solid tumors, and if so, which one is the higher priority trial at this point?”
Steve King: Just to remind everyone, we had actually 2 separate collaborations. The 1st one was for a clinical basket-type study, in which we are looking multiple solid tumor indications, where the idea was to combine bavituximab with durvalumab + chemotherapy. The 2nd study was a Phase II study in NSCLC to combine bavi with durvalumab vs. durvalumab alone. Basically, what we want to do now is take a step back, we’ve got data from SUNRISE, what is that telling is - obviously it’s giving us a good reason to consider the trial design for the basket study. Do we at this point just simplify it and have it simply be a bavituximab + durvalumab study? Those are the kind of discussions that are ongoing. And then, on the Phase II NSCLC study, we're just taking a look at both of those studies and determining what is the right studies to run. My goal for the clinical program is, run studies in which we can quickly ask questions and answer questions and use that to guide the overall program. Whatt we want to do is make it the most efficient program. I think AstraZeneca really sees the value in that and, again, also to tie it in with what we are doing with NCCN, and UT Southwestern, and Sloan Kettering, so that, we get the value of a global program, not just of couple of clinical studies which will answer some questions but maybe leave others unanswered. I think that we are having very good discussions with AstraZeneca and we just want to come out with the best program overall that really allows us to rapidly generate data and to rapidly move the program forward.
TY: ”Can you tell us more detail about your NCCN collaboration? Specifically, what is the selection process of potential immuno-oncology combinations?”
Steve King: The process with NCCN, which is is pretty much kicking off, is that the NCCN is responsible for reviewing, putting together a proposal, and working with us to try to answer questions that are of interest to us, but at the end of the day, they are running the program. What’s important is, the NCCN is some of the leading cancer institutions in the U.S. In addition, it’s really the KOL's at those institutions who will be involved in our particular program and so, we couldn’t be in better hands than working with the key thought leaders to select and run clinical studies that will add the most value to our I-O combinations. So, they're responsible for it. We provide them with all the information we have to-date, where we see the gaps in the program, and then they basically take and run with it. Operationally, it’s great for us. It’s great to be involved with these leading institutions. It’s really just a win-win for us and for the investigators to be able to run these studies.
YP: ”Re: Avid's $58mm backlog, is this committed for Q4/FY16 (q/e 4-30-16) and for the full 4 qtrs of FY'17?”
Paul Lytle: Yes, it is revenue to be reported in Q4'16 and into FY'17.
3. George Zavoico – Jones Trading http://jonestrading.com
GZ: ”Sorry about SUNRISE. I was quite as surprised and the better than expected behavior of the control of docetaxel - that’s killed a bunch of Ph.3 trials already in the last several months - very unsettling patterns. But, we then see how it plays out with the patients that you are still treating. Re: the NCCN pgm, you mentioned in the PR that you are committing $2mm of research expense through the pgm. Can you give us an idea of the scope of what that can cover in terms of how many collaborations, how large the trials, how many trials you might be able to do, and also what the cost sharing aspect of it is? How much of it are you paying and how much of it, if any, is the NCCN contributing?”
Steve King: The funding we're committing [1-6-16: $2mm res. grant to NCCN http://tinyurl.com/zmxtpsb ] is really is our commitment to the program. Obviously providing bavituximab will be other piece of the commitment, but, clearly that’s not an issue, because we manufacture it here. The beauty of the NCCN, as I mentioned earlier, is #1 we’ve got KOL's involved in it, leading institutions who can help guide the program. The idea is that they will put out RFP's. We expect the funding will fund 3, 4, 5 different clinical studies; it’s going to depend on the scope of the studies and the proposals that come through. But basically for us it’s great, because they're operationalizing and running the studies. They obviously are picking sites that have a good track record in quick patient enrollment, good patient enrollment, and really adhering to what they’ve proposed in their proposals. So, for us it’s really a way to run multiple studies all under one umbrella at the same time to really again involve some of the key people that we want to be excited about the program as we go forward.
GZ: ”I presume that, because of the SUNRISE trial that was ongoing, I suspect you probably don’t have to make any more about bavituximab for a while, so that cost is pretty much covered already for these programs?”
Steve King: Yes, absolutely, we already have adequate stocks of bavituximab to support all these studies we are talking about. We don’t expect any of them to be huge studies to start with, but certainly we have more than adequate supplies on hand.
GZ: ”And I imagine that the $2mm is just a start, if things go pretty well, I'm sure that $2mm was not the ceiling here, right?”
Steve King: No, we can always adjust it. The $2mm is what the original agreement is for and so that covers all the initial scope of what we are trying to do with them. But, certainly if things goes we expect and we generate data we think that will help drive the program forward, we want to continue to work with NCCN and our other collaborators. Joe?
Joe Shan: This is basically a research agreement for $2mm, I think over a course of 2 years. So, maybe that gives you a sense of time and as Steve mentioned, typically it ends up being 4-6 investigator initiated trials. These are smaller studies, but I think the key is that, like Steve mentioned, it’s in our strategy of smaller quick studies that we can get.
GZ: ”Absolutely, you're tapping into an existing infrastructure at minimal cost...”
Joe Shan: Correct.
GZ: ”Given where you are now, that’s probably the best strategy to take. Re: timing, you said you are going to be entertaining RFPs. When do you think you might get the 1st trials underway?”
Joe Shan: I don’t think we have total clarity on that. We are starting that process of developing that RFP with the NCCN. Again, this is a program that they administer, they oversee, and that 2-yr period basically starts pretty soon. As soon as the RFP is developed, they’ll put it out and they are under contract to delivering study results and publications in a 2-yr timeframe.
GZ: ”Re: the MSKCC collab, you mentioned a couple of tantalizing comments that you're already seeing some interesting data. Maybe it’s too early, but can you comment on whether any aspects of it have been submitted for the AACR Meeting perhaps, or ASCO or later on in the fall? When will we start seeing some of the MSKCC data in other words?”
Steve King: Our Sloan Kettering collaboration is obviously ongoing in a number of different areas, and so far we have been very happy with the way it’s progressing. I think some of the data is coming through on that. I can’t comment on what they’ve submitted at this point, but certainly, the goal of both of our groups is to generate data that we can not only go out and present at major conferences like AACR, but also to publish and really help guide the clinical program. I think along those lines, it’s important to note that Memorial Sloan Kettering is one of the institutions within the NCCN, so, obviously that’s another nice fit of how we're putting everything together from a cohesiveness point. So, clearly we'd like nothing better than to see some of the great ideas from our collaborators end up in clinical studies and driving the program forward.
GZ: ”Re: Avid, you're working with certain margins on the pre-existing facility without the disposables. The disposables enable much less expensive manufacturing… how do you expect the margins to change with the new facility?”
Paul Lytle: In terms of our mfg. contracts, the mfg. fees are fairly consistent, whether it’s in stainless steel or it’s in single-use bioreactors. So we expect the revenue to be very similar. In terms of the cost structure, a significant portion of the cost structure is really built into labor and whether you are doing it with our traditional facility or with the single-use, the cost structure is fairly similar from a human resource standpoint. The one key thing here is that the changeover time between stainless steel & single-use is much quicker, so we can shrink the amount of time between mfg. runs and potentially drive a lot more output out of a single-use facility.
Steve King: The other nice thing about the Myford facility is that it really was built for late-stage clinical & commercial production; ie, meant to upgrade in campaign mode, which means that you will have multiple reactors going simultaneously for a given product and then have a changeover to the next product. So actually the throughput of the facility could be even greater than what we have in our existing facility as we get more and more commercial production. And, as I said in earlier prepared remarks, we’ve seen a lot of interest from late-stage clinical & commercial clients and that’s really going to be instrumental in building a nice solid base for continuing to grow the business, because what you want is to constantly produce materials, make as many batches as you need, and then switchover, because now the client has what they need from a production standpoint and it allows us to move on to the next client and continue our production lines in a continuous way. That’s really a model for how we see the commercial facilities, and we’ve also seen a nice, as we want to continue to grow the business, a really big need for addl. clinical production as well. So, that’s another area of potential growth for the business as we continue to move forward. We are continuing to respond to the market needs by building on a nice solid base of existing clients that will have long-term needs.
GZ: ”Re: Avid, are you considering at all expanding into fill and finish? Also, have you increased the number of clients you are actually working with now or will be working with?”
Steve King: Yes, we definitely have new clients that have come onboard, and that’s what’s helping to drive some of the work we are seeing over in the Myford facility, the nice backlog in business for now building up over there. That’s been great, because when you build a facility, you're never quite sure what the response was going to be, but it’s been pretty overwhelming right now, which is good. On the fill/finish side, that is something we do have an interest in, particularly to support our clinical clients, for those in clinical stages of developments, because it will be a big benefit for them and I think another draw for bringing in that early-stage business. Commercial mfg. is a different beast altogether, so that’s one that as we get experience in fill/finish and see that there's a good track record we’ve built up, then moving in a commercial production might be something down the road. But, right now, quite frankly, we are so busy with bulk drugs substance manufacturing, and we want to continue to do what we do well and continue to grow that business.
4. Rahul Jasuja - Noble Life Science Partners http://noblelsp.com/research
RJ: ”On the SUNRISE trial, looking at the remnants of what you can salvage in terms of data here, you talked about looking at the immuno therapy effect in the remaining patients that are on bavi, or choose to stay on bavi. What immunological metrics will you be looking for? Are you looking for just tumor reduction or are you looking for particular immune metrics in the tumor micro environment that you are collecting as well?
Steve King: It’s a combination of all the above. We built into the SUNRISE study a lot of collection of samples & specimens from patients throughout the study that would allow us to do analysis, but while the trial was blinded we wouldn’t really be able to make sense out of it. Now that the study is unblinded, we can actually do the analysis of those samples and then start to put that together with the actual patient outcomes. One of the things that we can monitor closely with our collaborators, through NCCN or through our collaborations with Sloan Kettering and UTSW is, what all do we want to learn now, and in particular focus on those patients that really did well in the study, because the ultimate goal is to be able to select patients for future studies that are more likely to respond to therapy. There is every likelihood that within the SUNRISE study, that that information could be available, and we just want to be very methodical in how we generate that data, the testing we do to make sure that we get the maximum use of those samples that have been collected. So there's a lot of work that’s going on right now to finalize the plan, then over the coming months, we can complete the analysis and then at that time, we should have a much clear picture. #1, we’ll have more patient follow-ups, so we’ll know how more patients did, then to combine that with the data from the analysis we think can yield some really valuable information.
RJ: ”Now, my I-O question: this is a question about indications in combination with bavituximab. We did see pretty good data with AstraZeneca’s combination with PD-L1 [???] and their own CTLA-4 in mesothelioma and NCSLC. In fact, they do have orphan disease status and fast track with the FDA combining a CTLA-4 and a PD-L1, and these are PD-L1 low expressing tumors. So, extending into the rationale behind bavituximab also showing efficacy in PD-L1/ PD-L1 low tumors, is there a plan, given that data you're looking at, the PD-L1 approaches, and I think that some of the work was done by Scott Antonio, who's also an advisor to Peregrine. Is there a plan to move beyond, just NSCLC in combination with PD-L1 and in other PD-L1 low expressing tumors?”
Steve King: Absolutely, that’s really part & parcel of what we think we can do through all of our collaborators, AstraZeneca, the NCCN, Sloan Kettering, and UTSW, is to look at other indications. We’ve generated some interesting data earlier in liver cancer and other solid tumor types, so the opportunity to go into some of those indications where there is still clearly a high unmet medical need and patients not responding as well as everyone would like to the immuno therapy. So, we see a lot of opportunity in multiple indications outside of lung cancer, because we also recognize that lung cancer is becoming a crowded space and as you put more & more drug and drug combinations into the system, where is that an approvable indication? Now, the one benefit we think we will have in a durva, or any other PD-1/PD-L1 inhibitor, combination with bavi, is potentially on the safety side, and that really could pay dividends, because you can keep patients on treatment longer and you may be able to enhance that activity even further. So, that’s some of the things that we want to explore. First & foremost, which patients are going to respond the best, and then it's which indications or which tumor types we think then there's areas of opportunity. We want to simultaneously approach those 2 questions, and piece it together through small studies, generate good data, and then really expand it out from there - that really creates our value opportunity. The CTLA-4 + durva results are very good, but as with all of the other CTLA-4 combos of PD-1/PD-L1 inhibitors, there are significant toxicities and we think that’s where there could be an opportunity in the marketplace for safer combinations that have at least the same or maybe even greater activity.
RJ: ”Are there discussions in conjunction with AstraZeneca, or others, to address other tumors that are PD-L1 low, where conventional checkpoint inhibitors don’t work, or is this just an inate Peregrine-driven effort?”
Steve King: There is definitely the interest, clearly, in some of the other tumor types that haven’t historically responded as well to the I-O agents; breast cancer for instance, but there are other examples where we think bavi does have activity, and we want to see if we can take advantage of that from a 'priming the system', if you will, to be able to keep that immune response going with the PD-1/PD-L1 inhibitors. Yes, that’s definitely a big topic of interest is how do we, not just continue to add on and add on in lung cancer, but how do we actually get more and more tumor types to respond, and we think we can have a good role there and that’s one of the things we want to explore, either through the AZ basket study or even through some of the other collaborations we have ongoing.
5. Joe Pantginis FOLLOWUP – Roth Capital Partners: [ http://www.roth.com ]
JP: ”To George’s earlier question, how much bavi you have in your stores right now? And what’s the shelf life?”
Steve King: I don’t think we have any public information there, but we have more than enough in supply to basically be able to run all the studies we are talking about through NCCN or with our other collaborator, AZ. So drug supply will not be an issue, which is good because that offers us more capacity for the clients over in the Myford facility. So, that’s all positive at this point. With regard to the shelf life, our goal, as with any commercial product, is multiple years of stability in the bulk stage and then multiple years in the final vial, so, you end up with a lot of shelf life at the end of the day. That's helpful now, and it’s very helpful once you get to the commercial phase.
JP: ”Can you just remind us with regard to the current terms if you will with AstraZeneca, are they supplying durvalumab free of charge?”
Steve King: Yes, they are.
6. Joseph Tascalusia (sp???)
”This is a follow-up to Mr. Pantginis’ question. Is there a plan in place to possibly restructure expenses to more closely align with the Avid revenues, because it would suddenly appear with the stock price at $.40 that the ATM is no longer a viable option?”
Steve King: We are looking at the overall program. #1, we want to continue to grow revenues on the Avid side of the business. So that’s good, more money that’s coming in. On the expense side of things, we’ve already put on hold the other chemotherapy combination studies which were planned to be a significant part of our go-forward strategy, and still may be in the future, we need just more data from the SUNRISE study and then we can reevaluate. But, in the mean time, the concept is we want to be very efficient; the collaborations such as NCCN are very efficient from a cash utilization standpoint. The types of studies we run with AZ, we want to really gear those toward answering specific questions, maybe in a smaller format, which does 2 things: one it allows us to quickly generate data, but then to grow those studies, if you will, based on positive results, and positive results are going to have an impact on the market perception of the drug and what our value is. And so, we want to really take a step-wise approach, but I think we can generate good positive data without running huge hundreds and hundreds of patient studies, but really go through small studies, build on success and then use that as a springboard to even bigger studies with the idea being that, at that point, partners can jump in to help us run those studies. I think the market will respond to positive data in showing that we have good potential with the PD-1/PD-L1 inhibitor-class of drugs.
MR. KING’S CLOSING COMMENTS:
Okay, I’d like to thank again all of you for participating in today’s phone call. As always, I want to thank our stockholders for their continued support, and I would like to especially thank patients, their families and the investigators that are participating in our bavituximab clinical trials. With that, we will conclude the call.
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12-10-15 PR: ”Peregrine Pharmaceuticals Reports Financial Results for 3rd Qtr of FY 2016 and Recent Developments”
--Company Focused on Advancing Its Bavituximab Immuno-Oncology Program Through Its Pharmaceutical, Academic and Clinical Collaborations
--Full FY 2016 Revenue From Biomanufacturing Business, Avid Bioservices, Expected to Top $40 Million
--New State-of-the-Art Production Facility Commissioned and Ready for GMP Manufacturing Expands Revenue Potential
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=959623
TUSTIN, March 9, 2016: Peregrine Pharmaceuticals, Inc. (PPHM) (PPHMP), a biopharmaceutical company focused on developing therapeutics to stimulate the body's immune system to fight cancer, today announced financial results for the third quarter of fiscal year (FY) 2016 ended January 31, 2016, and provided an update on its advancing clinical pipeline and other corporate developments.
HIGHLIGHTS SINCE OCTOBER 31, 2015
“Earlier this week, we announced the commissioning of our new commercial biomanufacturing facility, which gives us significant revenue growth potential over the short term. This represented a key corporate milestone and we are continuing to evaluate a number of additional opportunities to further expand this important, revenue-generating business,” stated Steven W. King, President and CEO of Peregrine. “On the drug development side, we unfortunately experienced a recent setback with the early discontinuation of our SUNRISE Phase III study evaluating the combination of bavituximab and chemotherapy. While we continue to collect patient follow-up data in the SUNRISE study and work to better understand the final trial outcome, we have made the decision to put a hold on our other chemotherapy combination trials so that we can make an informed decision on how to potentially proceed.”
Mr. King continued, “In the meantime, we remain enthusiastic about the potential of combining bavituximab with other immuno-oncology (“I-O”) agents based on a significant amount of translational and preclinical data demonstrating that bavituximab has the potential to enhance the activity of checkpoint inhibitors. These I-O combinations are based on completely different mechanistic synergies than the chemotherapy combinations and the interest in pursuing this development pathway remains high. We are in the process of engaging all of our collaborators to formulate a comprehensive clinical strategy for exploring the potential of bavituximab with immune checkpoint inhibitors, such as PD-L1 and PD-1 inhibitors. The overall goal of these efforts is to generate important clinical data that will guide the program toward the specific patient populations that can realize the biggest benefit from these I-O combination treatments.”
CLINICAL DEVELOPMENT HIGHLIGHTS
Peregrine is working closely with its collaborators and key opinion leaders (“KOLs”) to transition the company’s clinical program to focus on bavituximab combinations with I-O agents. Peregrine’s partners and advisors, including AstraZeneca, Memorial Sloan Kettering Cancer Center, the National Comprehensive Cancer Network (NCCN) and the University of Texas, Southwestern, are leaders in the field of immuno-oncology, and their collective guidance will play an important role in the program. Activities in this area include:
Peregrine and AstraZeneca are currently evaluating the trial designs for the two previously announced clinical trials combining bavituximab with AstraZeneca’s PD-L1 inhibitor, durvalumab. In light of the recent development in the SUNRISE trial, the companies are currently working together to identify the optimal path forward for demonstrating potential mechanistic synergies between bavituximab and durvalumab in different patient populations. The expected timing of initiation of any trial will be determined upon finalization of its trial design.
Peregrine entered into a new research collaboration with the NCCN to expand upon the company's clinical development program of bavituximab in combination with immuno-oncology agents for the treatment of a range of tumors. NCCN is a not-for-profit alliance of 26 of the world's leading cancer centers dedicated to improving the quality, effectiveness, and efficiency of cancer care. Peregrine will fund multiple investigator-initiated clinical and correlative studies with bavituximab in multiple cancers at NCCN Member Institutions and their affiliate community hospitals through a $2 million research grant to NCCN's Oncology Research Program (ORP). NCCN will be responsible for oversight and monitoring of the clinical studies through the research grant.
SUPPORTIVE RESEARCH HIGHLIGHTS
Positive results were presented at the 2015 annual meeting of the Society for Immunotherapy of Cancer (SITC) from multiple new preclinical studies demonstrating enhanced anti-tumor activity and immune activation for combinations of a preclinical bavituximab equivalent and checkpoint inhibitors such as anti-PD-1 and anti-CTLA-4 in preclinical models of breast cancer and melanoma. Additionally, the company announced preliminary results for a new clinical test specifically designed to illustrate how bavituximab modulates immune responses in the tumor microenvironment.
AVID BIOSERVICES HIGHLIGHTS
“The Avid business grew 20% in FY 2015 to $26.7 million in revenue, and is expected to top $40 million in revenue for the current FY ending April 30, 2016,” stated Paul Lytle, CFO of Peregrine. “Our new state-of-the-art, 40,000 square foot commercial biomanufacturing facility, which was recently formally commissioned, is outfitted with cutting-edge, single-use equipment to accommodate a fully disposable biomanufacturing process for late Phase III clinical and commercial production of biologics. Demand for this new production capacity is high and we already have manufacturing commitments for products to be delivered in FY 2017. With demand expected to grow, we are actively considering options for potentially adding more production capacity to support additional growth of this business.”
Avid’s new state-of-the-art commercial biomanufacturing suite has been formally commissioned. The new facility will double the company’s prior manufacturing capacity, supporting up to an additional $40 million in revenue each year. As of February 1, 2016, Avid Bioservices had a revenue backlog in excess of $58 million under committed contracts from existing clients, covering services to be completed in the fourth quarter of FY 2016 and into FY 2017.
FINANCIAL RESULTS
Total revenues for the third quarter of FY 2016 were $6,709,000, compared to $5,677,000 for the same quarter of the prior fiscal year. The increase was attributed to an increase in contract manufacturing revenue generated from Avid Bioservices. Contract manufacturing revenue from Avid's clinical and commercial biomanufacturing services provided to its third-party clients for the third quarter FY 2016 were $6,672,000, compared to $5,677,000 for the same quarter of the prior FY. Peregrine expects third-party contract manufacturing revenue for the entire FY to exceed $40 million. In addition to providing biomanufacturing services to its third-party clients, Avid will continue to support the clinical manufacturing of bavituximab.
Total costs and expenses in the third quarter of FY 2016 were $23,576,000, compared to $18,699,000 in the third quarter of FY 2015. This increase was primarily attributable to current quarter increases in research and development expenses associated with the increase in manufacturing costs associated with bavituximab, the planned Phase II immuno-oncology combination trial of bavituximab and durvalumab in NSCLC, the Phase II chemotherapy combination trial in breast cancer that was initiated in December 2015 and recently placed on hold, and an increase in the cost of contract manufacturing associated with higher reported revenue. For the third quarter of FY 2016, research and development expenses were $15,156,000, compared to $11,261,000 for the third quarter of FY 2015. For the third quarter of FY 2016, cost of contract manufacturing was $3,896,000, compared to $3,113,000 for the third quarter of FY 2015. Selling, general and administrative expenses were $4,524,000 for the third quarter of FY 2016 compared to the $4,325,000 for the third quarter of FY 2015.
Peregrine's consolidated net loss attributable to common stockholders was $18,227,000, or $.08 per share [Op-Burn: 15,086,000 - see 10-Q p.27], for the 3rd quarter of FY 2016, compared to a net loss attributable to common stockholders of $14,027,000, or $0.08 per share, for the same prior year quarter.
Peregrine reported $67,470,000 in cash and cash equivalents as of January 31, 2016 compared to $68,001,000 at fiscal year ended April 30, 2015.
More detailed financial information and analysis may be found in Peregrine's Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today. [ http://tinyurl.com/hdgto9y ]
CONFERENCE CALL
Peregrine will host a conference call and webcast this morning, March 9, 2016, at 11:30AM ET (8:30AM PT). To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Peregrine Pharmaceuticals conference call. To listen to the live webcast, or access the archived webcast, please visit: http://ir.peregrineinc.com/events.cfm .
ABOUT PEREGRINE PHARMACEUTICALS, INC.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company developing therapeutics to stimulate the body's immune system to fight cancer. The company is focused on evaluating its lead immunotherapy candidate, bavituximab, in combination with a range of novel immuno-oncology (I-O) agents for the treatment of various cancers. In addition to its drug development programs, Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com ), which provides development and biomanufacturing services for both Peregrine and third-party customers. For more information, please visit http://www.peregrineinc.com .
ABOUT AVID BIOSERVICES
Avid Bioservices provides a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With over 15 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, Avid's services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support. The company also provides a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. For more information about Avid, please visit http://www.avidbio.com .
Safe Harbor *snip*
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
THREE MONTHS ENDED NINE MONTHS ENDED
JANUARY 31, JANUARY 31,
2016 2015 2016 2015
REVENUES:
Contract manufacturing revenue $ 6,672,000 $ 5,677,000 $ 25,574,000 $ 17,436,000
License revenue 37,000 - 329,000 37,000
Total revenues 6,709,000 5,677,000 25,903,000 17,473,000
COSTS AND EXPENSES:
Cost of contract manufacturing 3,896,000 3,113,000 13,245,000 10,835,000
Research and development 15,156,000 11,261,000 43,264,000 31,465,000
Selling, general and administrative 4,524,000 4,325,000 13,839,000 13,503,000
Total costs and expenses 23,576,000 18,699,000 70,348,000 55,803,000
LOSS FROM OPERATIONS (16,867,000 ) (13,022,000 ) (44,445,000 ) (38,330,000 )
OTHER INCOME (EXPENSE):
Interest and other income 34,000 29,000 691,000 108,000
Interest and other expense (14,000 ) (1,000 ) (14,000 ) (1,000 )
Total other income (expense), net 20,000 28,000 677,000 107,000
NET LOSS $ (16,847,000 ) $ (12,994,000 ) $ (43,768,000 ) $ (38,223,000 )
COMPREHENSIVE LOSS $ (16,847,000 ) $ (12,994,000 ) $ (43,768,000 ) $ (38,223,000 )
Series E preferred stock accumulated dividends (1,380,000 ) (1,033,000 ) (3,448,000 ) (2,577,000 )
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS $ (18,227,000 ) $ (14,027,000 ) $ (47,216,000 ) $ (40,800,000 )
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:
Basic and Diluted 227,389,225 182,519,923 209,549,670 180,562,524
BASIC AND DILUTED LOSS PER COMMON SHARE $ (0.08 ) $ (0.08 ) $ (0.23 ) $ (0.23 )
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
JANUARY 31,
2016 APRIL 30,
2015
Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 67,470,000 $ 68,001,000
Trade and other receivables, net 8,599,000 3,813,000
Inventories 15,189,000 7,354,000
Prepaid expenses and other current assets, net 2,346,000 1,355,000
Total current assets 93,604,000 80,523,000
Property and equipment, net 23,846,000 15,124,000
Other assets 1,602,000 1,817,000
TOTAL ASSETS $ 119,052,000 $ 97,464,000
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable $ 7,844,000 $ 10,385,000
Accrued clinical trial and related fees 6,975,000 3,910,000
Accrued payroll and related costs 4,497,000 4,606,000
Deferred revenue 15,418,000 6,630,000
Customer deposits 22,433,000 11,363,000
Other current liabilities 1,047,000 437,000
Total current liabilities 58,214,000 37,331,000
Deferred rent, less current portion 905,000 1,098,000
Commitments and contingencies
STOCKHOLDERS’ EQUITY:
Preferred stock – $0.001 par value; authorized 5,000,000 shares; 1,577,440 and 1,574,764 shares issued and outstanding at January 31, 2016 and April 30, 2015, respectively 2,000 2,000
Common stock – $0.001 par value; authorized 500,000,000 shares; 232,231,242 and 193,346,627 shares issued and outstanding at January 31, 2016 and April 30, 2015, respectively 232,000 193,000
Additional paid-in capital 557,091,000 512,464,000
Accumulated deficit (497,392,000 ) (453,624,000 )
Total stockholders’ equity 59,933,000 59,035,000
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 119,052,000 $ 97,464,000
CONTACTS:
• Jay Carlson Peregrine Pharmaceuticals, Inc. 800-987-8256 info@peregrineinc.com
• Stephanie Diaz (Investors) Vida Strategic Partners 415-675-7401 sdiaz@vidasp.com
• Tim Brons (Media) Vida Strategic Partners 415-675-7402 tbrons@vidasp.com
- - - - - - - - -
[ From 10-Q header: “As of Mar. 8 2016, there were 233,738,426 shares outstanding.”
- - - - - - - - - - - - - - - - -
Latest 10K 4-30-15 iss. 7-14-15 http://tinyurl.com/ocrtkuj PR: http://tinyurl.com/nw2v5u6 (Cash 4-30-15=$68.0mm)
Latest 10Q 1-31-16 iss. 3-9-16 http://tinyurl.com/hdgto9y PR: http://tinyurl.com/gom7md5 (Cash 1-31-16=$67.5mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
.
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Updated PPHM REVS-BY-QTR TABLE, now thru FY16'Q3(qe 1-31-16), per the 1-31-16 10-Q ( http://tinyurl.com/hdgto9y ) issued 3-9-16.
• Total Revs since May’06: ($154.8mm/Avid + $24.1mm/Govt + $2.5mm/Lic.) = $181.4mm
• 3-9-16: FY'16 (May'15-Apr'16) Avid revs guidance raised from $35-40mm to “over $40mm”.
• Deferred-Revs at 1-31-16 total $15.4mm, UP from $9.7mm at 10-31-15.
• Cust.Deposits at 1-31-16 total $22.4mm, UP from $14.9mm at 10-31-15.
• Inventories at 1-31-16 total $15.2mm, UP from $12.6mm at 10-31-15.
• Avid’s Gross-Profit over last 3 qtrs: $12.3mm on revs of $25.6mm (GP%=48%)
• Recall, Avid Rev$ from Gov’t DTRA Contract work (6/30/08 – 4/15/11, totaling $24.15mm), went into GOVT-REVS, not AVID-REVS, in the Financials.
Avid’s website: http://www.avidbio.com
*The 10-Q’s define OPER.BURN as, ”Net cash used in operating activities before chgs. in operating assets & liabilities”.
The 7-21-2001 10Q explains OP.BURN very nicely:
“RESULTS OF OPERATIONS. Before we discuss the Company's total expenses (cash & non-cash expenses), we would like to discuss the Company's operational burn rate (cash expenses used in operations, net of interest and other income) for q/e July 31, 2001 compared to the same period in the prior year. The operational burn rate is calculated by taking the net income (loss) from operations and subtracting all non-cash items, such as the recognition of deferred license revenue, depreciation and amortization and stock-based compensation expense.”
- - - - - - - - PPHM’s Fiscal Qtr’s (FY runs May – April):
FY’10-Q3 = q/e 1-31-10 – rep. 3-11-10 Thu (B4 mkt)
FY’10-Q4 = q/e 4-30-10 – rep. 7-14-10 Wed (after mkt)
FY’11-Q1 = q/e 7-31-10 – rep. 9-9-10 Thu (after mkt)
FY’11-Q2 = q/e 10-31-10 – rep. 12-9-10 Thu (after mkt)
FY’11-Q3 = q/e 1-31-10 – rep. 3-11-11 Fri (after mkt)
FY’11-Q4 = q/e 4-30-11 – rep. 7-14-11 Thu (after mkt)
FY’12-Q1 = q/e 7-31-11 – rep. 9-9-11 Fri (B4 mkt)
FY’12-Q2 = q/e 10-31-11 – rep. 12-12-11 Mon (after mkt)
FY’12-Q3 = q/e 1-31-12 – rep. 3-9-12 Fri (after mkt)
FY’12-Q4 = q/e 4-30-12 – rep. 7-16-12 Mon (after mkt)
FY’13-Q1 = q/e 7-31-12 – rep. 9-10-12 Mon (B4 mkt)
FY’13-Q2 = q/e 10-31-12 – rep. 12-10-12 Mon (after mkt)
FY’13-Q3 = q/e 1-31-13 – rep. 3-12-13 Tue (after mkt)
FY’13-Q4 = q/e 4-30-13 – rep. 7-11-13 Thu (after mkt)
FY’14-Q1 = q/e 7-31-13 – rep. 9-9-13 Mon (after mkt)
FY’14-Q2 = q/e 10-31-13 – rep. 12-10-13 Tue (after mkt)
FY’14-Q3 = q/e 1-31-14 – rep. 3-7-14 Fri (B4 mkt)
FY’14-Q4 = q/e 4-30-14 – rep. 7-14-14 Mon (after mkt)
FY’15-Q1 = q/e 7-31-14 – rep. 9-9-14 Tue (after mkt)
FY’15-Q2 = q/e 10-31-14 – rep. 12-10-14 Wed (after mkt)
FY’15-Q3 = q/e 1-31-15 – rep. 3-12-15 Thu (after mkt)
FY’15-Q4 = q/e 4-30-15 – rep. 7-14-15 Tue (after mkt)
FY’16-Q1 = q/e 7-31-15 – rep. 9-9-15 Wed (after mkt)
FY’16-Q2 = q/e 10-31-15 – rep. 12-10-15 Thu (after mkt)
FY’16-Q3 = q/e 1-31-16 – rep. 3-9-16 Thu (B4 mkt)
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“Going Concern” statement ELIMINATED from 4-30-13 10-K issued 7-11-2013…
2012: 4-30-12 10-K iss. 7-16-12 http://tinyurl.com/79o57b2
Pg.68: “As more fully described in Note 2, the Company’s recurring losses from operations and recurring negative cash flows from operating activities raise substantial doubt about its ability to continue as a going concern.”
2013 & 2014 & 2015 10-K's: http://tinyurl.com/p58jcbw etc...=> ((((NO GOING CONCERN STATEMENT INCLUDED.))))
CASH a/o 4-30-13: $35.2mm
CASH a/o 6-30-13: $42.6mm
CASH a/o 7-31-13: $41.6mm
CASH a/o 10-31-13: $44.4mm
CASH a/o 1-31-14: $63.2mm
CASH a/o 2-15-14: $79.7mm
CASH a/o 4-30-14: $77.5mm
CASH a/o 6-30-14: $78.3mm
CASH a/o 7-31-14: $73.3mm
CASH a/o 10-31-14: $64.4mm
CASH a/o 1-31-15: $55.2mm
CASH a/o 4-30-15: $68.0mm
CASH a/o 7-31-15: $59.0mm
CASH a/o 10-31-15: $72.0mm
CASH a/o 1-31-16: $67.5mm
= = = = = = = = = = A look at #Employees per the 10K’s…
2011 10-K: "As of 4-30-11, we employed 154 full-time emps & 2 part-time emps”
2012 10-K: "As of 4-30-12, we employed 172 full-time emps & 2 part-time emps."
2013 10-K: "As of 4-30-13, we employed 182 full-time emps & 5 part-time emps."
2014 10-K: "As of 4-30-14, we employed 180 full-time emps & 4 part-time emps."
2015 10-K: "As of 4-30-15, we employed 211 full-time emps & 4 part-time emps."
= = = = = = = = = = = = = = = = = =
3-7-16: Formal Commissioning of Avid's 40,000sq Expansion, “single-use/fully disposable” (potentially $40M addl revs) http://tinyurl.com/za2j9mt
...12-10-15: Avid Expansion into MYFORD Facility (Avid II) now GMP-run ready (potential +$40mm sales) - contemplating further expansion http://tinyurl.com/z35623w
1-18-16: CEO Steve King's 1-18-16 presentation at Noble-Financial's Investor Conf. (21min replay, 31 slides) http://tinyurl.com/j9dkekm
1-11-16: Update on 4 New Bavi Clinical Trials (Lung/AZN, Breast/1Co./1MSKCC, Other Cancers/AZN). SUNRISE est's: Look1=Early'16, Look2=Mid'16, FinalUnblind=End'16 http://tinyurl.com/zhdy37a
1-6-16: Peregrine enters into Research Collab. with Natl-Comprehensive-Cancer-Network (NCCN) http://tinyurl.com/zmxtpsb
...$2mm res. grant to NCCN's Oncology Res. Pgm (ORP), will “significantly expand our clinical evaluation of Bavi and augment Peregrine's IST pgm at 26 of the world's leading cancer centers”.
12-10-15 Qtly. Conf. Call (King/Shan/Worsley/Garnick/Lytle) Transcript http://tinyurl.com/jkp885g
...CEO SK: “Although our SUNRISE enrollment milestone has been reached, we have no intention of slowing down, quite the opposite. We are aggressively moving to initiate new clinical trials [Lung, Breast, Mult-Types] that will allow us to build the most robust oncology business possible… With each of these studies our goal is the same - we are committed to identifying key indications, patient populations, and therapeutics that can benefit from combination treatment with bavituximab. From what we have seen to-date, the opportunity appears vast and we are hard at work converting the most promising prospects into true value.”
10-15-15 Peregrine's ASM: ATTENDEE Reports & Link to SK's 18min/16slide webcast: http://tinyurl.com/o6z4bm4
10-15-15: Peregrine & AstraZeneca Expand Collab. w/Ph2/2ndLine-NSCLC Trial, Bavi+durvalumab(MEDI4736), squamous or non-squamous. http://tinyurl.com/q79bkam
8-24-15: AstraZeneca & Peregrine Collaborate on Bavi+Durvalumab Ph1/1B Trial for “multiple solid tumors” http://tinyurl.com/owlxpsf
...Durvalumab=MEDI4736(anti-PD-L1 immune checkpoint inhibitor). AZN’s Head/I-O(Robert Iannone): “Our partnership with Peregrine provides the opportunity to explore an exciting, novel combination that could deliver important clinical benefit to patients across a range of cancers."
5-29-15: Peregrine & Sloan Kettering Enter Collab. to “Investigate Novel PS-Targeting Immunotherapy Combos” http://tinyurl.com/qxu4w2x
=> Total Revs May06-Jan16: $154.8mm/Avid + $24.1mm/Govt + $2.4mm/Lic. = $181.4mm. Cash at 1-31-16: $67.5mm
As of Mar. 8 2016, there were 233,738,426 shares outstanding.
This large post has 3 sections:
I. 3-9-16 Q3/FY16 Qtly. Earnings Conf. Call TRANSCRIPT (q/e 1-31-16)
II. 3-9-16 PPHM Press Release: Q3/FY16 Earnings & Developments
III. Updated Table of Avid Revenues By Quarter (May’06-Current)
…Recall: Peregrine’s FY runs May-Apr, so FY’16 = May’15-Apr’16.
((( Orig. transcript from SeekingAlpha.com [ http://tinyurl.com/hwm56ah ], with numerous corrections made. )))
Link to webcast replay: http://ir.peregrineinc.com/events.cfm => http://edge.media-server.com/m/p/iirfkpej
FULL TRANSCRIPT…
3-9-2016 FY’16/Q3 Earnings Conf. Call (q/e 1-31-16)
WELCOME & FWD-LOOKING STATEMENTS: Tim Brons, Vida Strategic Partners (IR) http://www.peregrineinc.com
Speakers: Steve King, Joe Shan, Stephen Worsley, Paul Lytle; Q&A session.
CEO STEVE KING – OPENING COMMENTS:
Thanks to all of you who have dialed in, and to all of you who are participating via webcast today. It is certainly been an interesting time at Peregrine since our last regularly scheduled conference call. On the downside was the recent announced discontinuation of our Phase III SUNRISE trial. On the upside was the announcement that we had completed formal commissioning of our new biomanufacturing facility and that the manufacturing in this facility was well underway, giving us a great new revenue source from which to continue growing the business, which this FY (FY16: May'15-Apr'16) will easily reach an all-time revenue high.
So, where do we go from here? First, we continue growing our thriving mfg. business, where we see the opportunity to grow even beyond the new mfg. facility. Demand for services is at an all-time high and, importantly, we are seeing significant opportunities for late-stage clinical and commercial production that can yield a solid base for future growth. So on this side of our business, it is business as usual, supporting our clients with their development and commercial production needs.
On the development side, it is a transition time for our bavituximab program. While the results of the interim analysis from the SUNRISE study are unfortunate, and it is a setback for our chemotherapy combinations with bavituximab, it is by no means the end of the program. For starters, we have not yet completed patient follow-up in the SUNRISE study, with the goal of learning as much as we possibly can from the trial. Important to note is that patients that enrolled in the study and are still active are continuing to receive chemotherapy and those patients that were on the bavituximab arm have the option to continue receiving bavituximab, and some have already expressed an interest in doing so. And, we will be continuing follow-up on these patients as well as survival follow-up of patients that have already exited the study. At this point, our goal for the study is to obtain data from the trial that can potentially be critical in how we move the chemotherapy combination program forward and even information that can help guide the overall program: which patients did particularly well in the study? what were their characteristics? - these are just a couple of examples of the many types of questions that we want to attempt to address as we wind down the SUNRISE trial, so that we can tailor patient selection in future studies. As we generate this data, we will be able to share it at the appropriate time in the future. As for advancing the program, we are as excited & confident as ever about the immuno-oncology combination potential of bavituximab. As you may recall, this was already the counterpart to the chemotherapy combinations based on a completely different mechanistic synergy; namely, to start an immune response in patients lacking a good immune response, and then prolong the immune response by blocking the PD-1/PD-L1 pathway that can counteract a strong immune response in patients. This combination hypothesis is still completely intact. We have generated a significant amount of translational & preclinical data demonstrating that bavituximab has the potential to enhance the activity of checkpoint inhibitors, and our goal for the coming year is to bring many of these concepts into the clinic and to demonstrate the potential of bavi in this important area of cancer therapy.
With our I-O combination program having been underway for sometime, long before the SUNRISE results, we have formed collaborations with some of the leading I-O players in the world: a collaboration with AstraZeneca to study bavi with their PD-L1 inhibitor durvalumab, a collaboration with researchers at Memorial Sloan Kettering Cancer Center to study novel combinations of bavituximab with I-O agents, a collaboration with National Comprehensive Cancer Network (NCCN) to run multiple clinical studies focused on I-O combinations at some of the 26 leading cancer centers in the U.S. that are part of the network, with significant involvements, as part of the program, from KOL's at those institutions, all in addition to our long time collaborations at the Univ. of Texas SW Med. Ctr. that will continue to be active in pushing forward I-O combinations. The main difference with the SUNRISE results in hand is that the I-O combination program has become our major area of clinical focus and, as such, we are working with all of our collaborators to redefine the program in order to have a cohesive & comprehensive strategy that ties together the efforts of all of our collaborators and will allow us to rapidly advance the program. The strategy will involve studies designed to answer specific questions about particular patient populations where we already have evidence that bavi may have the biggest impact, allowing us to more quickly generate data that we can build on as we advance the program. These planning efforts are well underway as we speak, and we look forward to updating you as they are implemented into the clinic. I will now turn the call over to Joe Shan, VP, Clinical & Regulatory.
JOE SHAN (VP/Clin.&Reg. Affairs) – CLINICAL TRIALS:
I’d like to start by speaking about our Phase III SUNRISE trial, which we discontinued in late February [2-25-16: http://tinyurl.com/jbg48vs ]. The decision to stop the trial was based on the recommendation on the study’s Independent Data Monitoring Committee (IDMC), following a pre-specified interim analysis. While the interim analysis showed that the bavituximab combination group was performing as expected according to the original trial assumptions in terms of overall survival, it also demonstrated that the docetaxel group had dramatically outperformed OS expectations based on the original trial assumptions and as compared to recently published studies. Nevertheless, enrollment has been stopped and we are now in the process of winding down the trial. As part of this process, patients who are still receiving study treatment are given the option completing their chemotherapy, and for those patients assigned to the bavituximab arm, they continue to receive bavituximab if the investigator believes this is in the patient’s best interest. Because I-O agents can elicit delayed responses and prolonged survival, we are continuing to follow such patients to evaluate their outcomes. Such information will certainly be valuable and help us form future decisions for the company. As we continue to collect and clean the remaining data, we are also conducting a thorough evaluation of the already available clinical data. While we perform these analyses, we’ve put a hold on the trials that combine bavituximab with chemotherapy until we have a clearer understanding of SUNRISE study results. Specifically, we have put our recently initiated Phase II/III breast cancer trial on hold, as well as the start-up activities for a Phase II early-stage breast cancer trial. It is our plan to publish our findings from SUNRISE when it is completed and we will provide an update on this process next quarter.
Looking ahead, our priority is to generate clinical evidence of bavituximab’s ability to improve patient outcomes when combined with immuno-oncology agents. To this end, AstraZeneca and we are currently evaluating a trial design for the 2 previously announced clinical trial combining bavituximab with AZ’s PD-L1 inhibitor durvalumab. In light of the recent development in the SUNRISE trial, our companies are currently working together to identify the optimal path forward for demonstrating potential mechanistic synergies between bavituximab & durvalumab in different patient populations. We are particularly interested in combing bavituximab with checkpoint inhibitors because it has been observed that checkpoint inhibitors are most effective when there is a pre-existing T-Cell response in tumors. Importantly, we have pre-clinical evidence that bavituximab-like antibodies trigger CD+ T-Cell responses which can be prolonged by the addition of PD-1 checkpoint inhibitors. Another important observation we’ve recently made is that our PS signaling pathway inhibitors demonstrate multiple signs of immune activation in low or negative PD-L1 expressing tumors. We believe that this holds great potential to increase the number of patients able to respond to checkpoint therapies. Based on these observations, we believe that by combining these 2 projects the potential exists for a more complete
& lasting anti-tumor immune response.
Lastly, I’d like to comment on our newest collaboration with the NCCN. The goal of this partnership is to build upon the company’s clinical dev. program of bavituximab in combination with I-O agents for the treatment of a range of tumors. NCCN is a not-for-profit, alliance of 26 of the world’s leading cancer centers dedicated to improving the quality, effectiveness, and efficiency of cancer care. Through this collaboration, Peregrine will have an opportunity to fund multiple investigator initiated clinical & correlative studies with bavituximab in a range of cancers at the NCCN member institutions and their affiliate community hospitals. We believe this relationship will prove to be highly valuable, as it will allow Peregrine to expand and augment our bavituximab clinical dev. program through experienced investigators & world-class institutions. It would be impossible for a company of our size & stage to gain access to incredible institutions and clinical thought leaders otherwise. This collaboration remains quite new, but we look forward to reporting our progress in the not too distant future. This concludes my comments today. I will now turn the call over to Steve Worsley to give an overview of the business dev. and mfg. activities.
STEPHEN WORSLEY (VP/Business Dev.):
As Joe provided an update on our collaborations with AstraZeneca and the NCCN, I’d like to provide an update on Peregrine’s other I-O-focused collaboration with the Memorial Sloan Kettering Cancer Center. The goal of this partnership is to evaluate combinations of bavituximab with other checkpoint inhibitors & immune stimulatory agents for the purpose of developing new and increasingly effective anti-cancer treatments. This work is advancing well. To-date, we have seen initial signs of activity with new combinations with bavituximab and other treatment modalities, such as checkpoint blockers, T-Cell agonists, and radiation. Our plan is to spend the next year investigating these possible combination potentials. We are also renewing the contract for next year as we’ve seen exciting results thus far.
I’d now like to discuss our biomanufacturing business, Avid Bioservices, as we announced earlier this week, our new state-of-the-art commercial biomanufacturing suite, which we call the Myford facility, has been formally commissioned [3-7-16: http://tinyurl.com/za2j9mt ]. As part of the commissioning process, all relevant regulatory agencies have been notified and GMP production is currently underway. The new facility, which is being operated by Avid Bioservices, will more than double the company’s prior mfg. capacity. The 40,000sf biomanufacturing facility, which is located adjacent to the company’s current campus in Orange County, is outfitted with cutting-edge, single-use equipment to accommodate a fully disposable biomanufacturing process for late Phase III clinical & commercial production of biologics. Despite its world-class design, the Myford facility was completed for a fraction of the cost of building comparable facilities, something of which we are quite proud. The suite is capable of operating reactors as large as 2000 liters in volume. GMP material produced in new facility can be used either in clinical trials or for commercial sales once Peregrine or its partners make the appropriate regulatory filings. Demand for this new production capacity is high, and we already have locked commitments extending well into 2017. As this demand continues to grow, it leads us to consider options for potentially adding more production capacity in the near future. We are currently evaluating a number of opportunities to meet this demand and are extremely optimistic about the growth of this business. We believe that the Avid business will continue to be a tremendous source of new business for Peregrine, and it is our goal to pursue every opportunity to build demand and expand capacity. That concludes my comments. I will now turn the call over to CFO Paul Lytle who will discuss the company’s financial performance, including addl. details regarding our Avid Bioservices business.
CFO Paul Lytle:
We are pleased to report that we continue to see significant growth in our contract mfg. business. Last qtr, we raised our FY'16 [May'15-Apr'16] revenue guidance from $30-35mm to $35-40mm and today, we believe we can exceed this guidance and top $40mm in contract mfg. revenues for the full FY'16. This represents revenue growth of ~50% over the prior FY, in addition to the continued growth we’ve seen over the last several years. I would also like to point out that our mfg. revenue for the full FY'16 will be solely derived from our existing mfg. facilities and our newly commissioned facility has the potential to generate an addl. $40mm in mfg. revenue.
Turning to the current qtr, we generated contract mfg. revenue of $6.6mm, representing an 18% increase compared to the same prior year qtr, and YTD we recorded mfg. revenue of $25.6mm or a 47% increase compared to the same prior year period. Our outlook for this business remains very positive, with our customers continuing to book available production capacity. Our revenue backlog has grown from $49mm reported in the last qtr to over $58mm as of Feb. 1, 2016, the beginning of our Q4. Looking ahead, we expect Avid Bioservices to continue to play a critical role in our business. Avid continues to generate non-diluted income that significantly reduces the amount of capital we need to raise by other means. For this reason, growing the Avid business will remain a high priority for the company.
Now turning to expenses, R&D expenses for the qtr increased primarily due to the increased mfg. costs associated with bavituximab, combined with increased cost associated with the previously planned Phase II trials in breast cancer & lung cancer, while G&A expenses remained relatively flat qtr-over-qtr. A more detailed analysis of our statement of operations is included in our Form 10-Q that will be filed later today [10-Q: http://tinyurl.com/hdgto9y ]. This concludes my financial overview, and I will now turn the call back over to Steve to discuss some important upcoming milestones.
CEO STEVE KING – MILESTONES:
As you’ve heard from our team today, Peregrine remains a strong company with a valuable clinical asset and a rapidly growing biomanufacturing business. The important work of developing bavituximab as an anti-cancer therapeutic continues. We believe our relationships with AstraZeneca, Memorial Sloan Kettering, UT Southwestern, and with the NCCN will be invaluable as we establish & execute our overall strategy for advancing the bavituximab I-O combination plans in a range of cancers. And, our Avid Bioservices business continues to outpace our initial projections providing a steady growing revenue stream. The Avid business grew 20% in FY'15 to $26.7mm in revenue, and is expected to exceed $40mm in FY'16, with our new “Myford” facility now online to help drive further growth in FY'17. It is fair to say that Avid has experienced significant success, and we are evaluating a number of opportunities to continue to expand this important business. This concludes our prepared remarks and we would now like to open the line for questions.
Q&A: [19:10 mark]
1. Joe Pantginis – Roth Capital Partners: [ http://www.roth.com & https://roth2.bluematrix.com/docs/pdf/BLUE.pdf ]
JP: ”With regard to the overall operations of Peregrine, you are obviously looking at increased revenue from Avid, so with that in mind, how are you looking to fund the company going forward with regard to the Avid revenues, your outstanding ATM, and is there a potential for restructuring following the SUNRISE news?”
Paul Lytle: That’s a good question, Joe. We are very committed to maintaining a solid cash position to run our business. We’ve always said in the past that our goal is to maintain a balanced financial approach, so we like to complement our cash position with the revenues that are coming in for Avid. We can utilize potential offerings through the equity markets if we need to and then obviously we're looking at other opportunities. Different collaborations, different revenue streams, and growing the Avid business I think will be imperative for the company as we advance our business. So, again we are looking at maintaining and sustaining a very operational business here and to support our customers.
JP: ”And with regard to the size of the business and any potential restructuring?”
Paul Lytle: Currently, we have no restructuring in terms of the size of the business. Our goal is to continue to grow the business and we have plans to do that.
JP: ”OK, and switching to the I-O combination program, Steve, you made a comment about how the program is going to be redefined now, can you talk a little more about what that means; specifically, I know you had some certain views about what the AZ protocols might have looked like. Have those changed and what have your discussions been with AstraZeneca since the SUNRISE news?
Steve King: One of the things we’ve done, which is prudent, is, based on the SUNRISE data and the fact that we really need to understand what happened in that study - why did the control arm way outperform what we expected going into it. As Joe mentioned in his remarks, we have put on hold a couple of the clinical studies that would have been starting otherwise. This does two things – one, it gives us a chance to give more data from the SUNRISE trial and to make sense out of it; the 2nd is that it also controls expenditures in those areas and those were a couple of significant expenditures for the coming year. In addition, our overall strategy, and this pertains to both questions, is really to focus our clinical dev. efforts on studies that can yield, #1, quick data or as quick as possible, but also smaller studies that really allow us to build on early successes and then to grow our knowledge base as we expand into larger trials. It’s a huge benefit to be able to do that based on the tale, if you will, of good clinical data. Yes, we’ve entered into discussions with AstraZeneca, we are having discussions with NCCN, with our other collaborators at Sloan Kettering & UT Southwestern about, how do we put together a cohesive program, because we don’t want a bunch of individual activities that don’t fit well together, what we want is a program that allows us to answer critical questions in multiple indications simultaneously and then to build on solid clinical data, looking at patient populations such as PD-L1 negative, where we have already shown in some of our translational work and pre-clinical studies that may be where we can have a big impact, so we’ll be able to look at that in a clinical setting. But, taken overall, it also helps to control the burn rate until we can generate good clinical data that’s positive and then that of course should help both on the partnering as well as the funding fronts. So, we're taking this very step-wise, and continuing to grow the Avid business just makes good sense, because that really helps cover the overall business operations.
JP: ”Would you say that there has been no change to the tenor of your discussions with AstraZeneca?”
Steve King: What I would say is that the tenor of discussions has changed just because, what now makes the most sense, because the rationale for running the Phase II study in NSCLC was little bit different. It was really meant to augment a positive clinical study in chemo combination, and so they then had coverage for both the I-O combination as well as the chemotherapy combinations. I think now the goal has changed somewhat, and I think for both of us into, how do we now build on good clinical data and find those patient populations that are most likely to respond. So, it’s sparked of a lot of a new conversation, all which I think is very positive and I think also which will allow us to not just run studies with AZ, but also to incorporate what we are doing with NCCN, Sloan Kettering, UTSW into that overall plan which benefits both Peregrine & AstraZeneca and everyone involved.
JP: ”You mentioned re: SUNRISE that patients will be able to, if they request, remain on bavi. Do you have a sense of how many patients that might be, and the potential cost associated with it?”
Steve King: Yes, I think the potential cost will be relatively minimal just because, obviously, it’s going to be a portion of the patients that would be going forward with that, but it was already captured in the initial intent of running the study. But, the benefit far outweighs any expenditures associated with those infusions, because #1 we only have the drug, #2, it allows patients to stay on and as the data matures, our goal is still to get as much data from this study as possible, which includes which patient populations maybe doing better, is there a survival tale – a lot of questions we still want to answer and the more we are able to keep patients on the study, keep them going through, I think the more likely we are to be able to get some really nice data that we can again, really employ as we continue to advance the program.
2. Thomas Yip (FBR & Co.): http://www.fbr.com
TY: ”Re: your ongoing discussions with AstraZeneca, you mentioned it involves finalizing the design of 2 trials. I am just wondering whether it’s still a Phase II trial for NSCLC and then another trial for solid tumors, and if so, which one is the higher priority trial at this point?”
Steve King: Just to remind everyone, we had actually 2 separate collaborations. The 1st one was for a clinical basket-type study, in which we are looking multiple solid tumor indications, where the idea was to combine bavituximab with durvalumab + chemotherapy. The 2nd study was a Phase II study in NSCLC to combine bavi with durvalumab vs. durvalumab alone. Basically, what we want to do now is take a step back, we’ve got data from SUNRISE, what is that telling is - obviously it’s giving us a good reason to consider the trial design for the basket study. Do we at this point just simplify it and have it simply be a bavituximab + durvalumab study? Those are the kind of discussions that are ongoing. And then, on the Phase II NSCLC study, we're just taking a look at both of those studies and determining what is the right studies to run. My goal for the clinical program is, run studies in which we can quickly ask questions and answer questions and use that to guide the overall program. Whatt we want to do is make it the most efficient program. I think AstraZeneca really sees the value in that and, again, also to tie it in with what we are doing with NCCN, and UT Southwestern, and Sloan Kettering, so that, we get the value of a global program, not just of couple of clinical studies which will answer some questions but maybe leave others unanswered. I think that we are having very good discussions with AstraZeneca and we just want to come out with the best program overall that really allows us to rapidly generate data and to rapidly move the program forward.
TY: ”Can you tell us more detail about your NCCN collaboration? Specifically, what is the selection process of potential immuno-oncology combinations?”
Steve King: The process with NCCN, which is is pretty much kicking off, is that the NCCN is responsible for reviewing, putting together a proposal, and working with us to try to answer questions that are of interest to us, but at the end of the day, they are running the program. What’s important is, the NCCN is some of the leading cancer institutions in the U.S. In addition, it’s really the KOL's at those institutions who will be involved in our particular program and so, we couldn’t be in better hands than working with the key thought leaders to select and run clinical studies that will add the most value to our I-O combinations. So, they're responsible for it. We provide them with all the information we have to-date, where we see the gaps in the program, and then they basically take and run with it. Operationally, it’s great for us. It’s great to be involved with these leading institutions. It’s really just a win-win for us and for the investigators to be able to run these studies.
YP: ”Re: Avid's $58mm backlog, is this committed for Q4/FY16 (q/e 4-30-16) and for the full 4 qtrs of FY'17?”
Paul Lytle: Yes, it is revenue to be reported in Q4'16 and into FY'17.
3. George Zavoico – Jones Trading http://jonestrading.com
GZ: ”Sorry about SUNRISE. I was quite as surprised and the better than expected behavior of the control of docetaxel - that’s killed a bunch of Ph.3 trials already in the last several months - very unsettling patterns. But, we then see how it plays out with the patients that you are still treating. Re: the NCCN pgm, you mentioned in the PR that you are committing $2mm of research expense through the pgm. Can you give us an idea of the scope of what that can cover in terms of how many collaborations, how large the trials, how many trials you might be able to do, and also what the cost sharing aspect of it is? How much of it are you paying and how much of it, if any, is the NCCN contributing?”
Steve King: The funding we're committing [1-6-16: $2mm res. grant to NCCN http://tinyurl.com/zmxtpsb ] is really is our commitment to the program. Obviously providing bavituximab will be other piece of the commitment, but, clearly that’s not an issue, because we manufacture it here. The beauty of the NCCN, as I mentioned earlier, is #1 we’ve got KOL's involved in it, leading institutions who can help guide the program. The idea is that they will put out RFP's. We expect the funding will fund 3, 4, 5 different clinical studies; it’s going to depend on the scope of the studies and the proposals that come through. But basically for us it’s great, because they're operationalizing and running the studies. They obviously are picking sites that have a good track record in quick patient enrollment, good patient enrollment, and really adhering to what they’ve proposed in their proposals. So, for us it’s really a way to run multiple studies all under one umbrella at the same time to really again involve some of the key people that we want to be excited about the program as we go forward.
GZ: ”I presume that, because of the SUNRISE trial that was ongoing, I suspect you probably don’t have to make any more about bavituximab for a while, so that cost is pretty much covered already for these programs?”
Steve King: Yes, absolutely, we already have adequate stocks of bavituximab to support all these studies we are talking about. We don’t expect any of them to be huge studies to start with, but certainly we have more than adequate supplies on hand.
GZ: ”And I imagine that the $2mm is just a start, if things go pretty well, I'm sure that $2mm was not the ceiling here, right?”
Steve King: No, we can always adjust it. The $2mm is what the original agreement is for and so that covers all the initial scope of what we are trying to do with them. But, certainly if things goes we expect and we generate data we think that will help drive the program forward, we want to continue to work with NCCN and our other collaborators. Joe?
Joe Shan: This is basically a research agreement for $2mm, I think over a course of 2 years. So, maybe that gives you a sense of time and as Steve mentioned, typically it ends up being 4-6 investigator initiated trials. These are smaller studies, but I think the key is that, like Steve mentioned, it’s in our strategy of smaller quick studies that we can get.
GZ: ”Absolutely, you're tapping into an existing infrastructure at minimal cost...”
Joe Shan: Correct.
GZ: ”Given where you are now, that’s probably the best strategy to take. Re: timing, you said you are going to be entertaining RFPs. When do you think you might get the 1st trials underway?”
Joe Shan: I don’t think we have total clarity on that. We are starting that process of developing that RFP with the NCCN. Again, this is a program that they administer, they oversee, and that 2-yr period basically starts pretty soon. As soon as the RFP is developed, they’ll put it out and they are under contract to delivering study results and publications in a 2-yr timeframe.
GZ: ”Re: the MSKCC collab, you mentioned a couple of tantalizing comments that you're already seeing some interesting data. Maybe it’s too early, but can you comment on whether any aspects of it have been submitted for the AACR Meeting perhaps, or ASCO or later on in the fall? When will we start seeing some of the MSKCC data in other words?”
Steve King: Our Sloan Kettering collaboration is obviously ongoing in a number of different areas, and so far we have been very happy with the way it’s progressing. I think some of the data is coming through on that. I can’t comment on what they’ve submitted at this point, but certainly, the goal of both of our groups is to generate data that we can not only go out and present at major conferences like AACR, but also to publish and really help guide the clinical program. I think along those lines, it’s important to note that Memorial Sloan Kettering is one of the institutions within the NCCN, so, obviously that’s another nice fit of how we're putting everything together from a cohesiveness point. So, clearly we'd like nothing better than to see some of the great ideas from our collaborators end up in clinical studies and driving the program forward.
GZ: ”Re: Avid, you're working with certain margins on the pre-existing facility without the disposables. The disposables enable much less expensive manufacturing… how do you expect the margins to change with the new facility?”
Paul Lytle: In terms of our mfg. contracts, the mfg. fees are fairly consistent, whether it’s in stainless steel or it’s in single-use bioreactors. So we expect the revenue to be very similar. In terms of the cost structure, a significant portion of the cost structure is really built into labor and whether you are doing it with our traditional facility or with the single-use, the cost structure is fairly similar from a human resource standpoint. The one key thing here is that the changeover time between stainless steel & single-use is much quicker, so we can shrink the amount of time between mfg. runs and potentially drive a lot more output out of a single-use facility.
Steve King: The other nice thing about the Myford facility is that it really was built for late-stage clinical & commercial production; ie, meant to upgrade in campaign mode, which means that you will have multiple reactors going simultaneously for a given product and then have a changeover to the next product. So actually the throughput of the facility could be even greater than what we have in our existing facility as we get more and more commercial production. And, as I said in earlier prepared remarks, we’ve seen a lot of interest from late-stage clinical & commercial clients and that’s really going to be instrumental in building a nice solid base for continuing to grow the business, because what you want is to constantly produce materials, make as many batches as you need, and then switchover, because now the client has what they need from a production standpoint and it allows us to move on to the next client and continue our production lines in a continuous way. That’s really a model for how we see the commercial facilities, and we’ve also seen a nice, as we want to continue to grow the business, a really big need for addl. clinical production as well. So, that’s another area of potential growth for the business as we continue to move forward. We are continuing to respond to the market needs by building on a nice solid base of existing clients that will have long-term needs.
GZ: ”Re: Avid, are you considering at all expanding into fill and finish? Also, have you increased the number of clients you are actually working with now or will be working with?”
Steve King: Yes, we definitely have new clients that have come onboard, and that’s what’s helping to drive some of the work we are seeing over in the Myford facility, the nice backlog in business for now building up over there. That’s been great, because when you build a facility, you're never quite sure what the response was going to be, but it’s been pretty overwhelming right now, which is good. On the fill/finish side, that is something we do have an interest in, particularly to support our clinical clients, for those in clinical stages of developments, because it will be a big benefit for them and I think another draw for bringing in that early-stage business. Commercial mfg. is a different beast altogether, so that’s one that as we get experience in fill/finish and see that there's a good track record we’ve built up, then moving in a commercial production might be something down the road. But, right now, quite frankly, we are so busy with bulk drugs substance manufacturing, and we want to continue to do what we do well and continue to grow that business.
4. Rahul Jasuja - Noble Life Science Partners http://noblelsp.com/research
RJ: ”On the SUNRISE trial, looking at the remnants of what you can salvage in terms of data here, you talked about looking at the immuno therapy effect in the remaining patients that are on bavi, or choose to stay on bavi. What immunological metrics will you be looking for? Are you looking for just tumor reduction or are you looking for particular immune metrics in the tumor micro environment that you are collecting as well?
Steve King: It’s a combination of all the above. We built into the SUNRISE study a lot of collection of samples & specimens from patients throughout the study that would allow us to do analysis, but while the trial was blinded we wouldn’t really be able to make sense out of it. Now that the study is unblinded, we can actually do the analysis of those samples and then start to put that together with the actual patient outcomes. One of the things that we can monitor closely with our collaborators, through NCCN or through our collaborations with Sloan Kettering and UTSW is, what all do we want to learn now, and in particular focus on those patients that really did well in the study, because the ultimate goal is to be able to select patients for future studies that are more likely to respond to therapy. There is every likelihood that within the SUNRISE study, that that information could be available, and we just want to be very methodical in how we generate that data, the testing we do to make sure that we get the maximum use of those samples that have been collected. So there's a lot of work that’s going on right now to finalize the plan, then over the coming months, we can complete the analysis and then at that time, we should have a much clear picture. #1, we’ll have more patient follow-ups, so we’ll know how more patients did, then to combine that with the data from the analysis we think can yield some really valuable information.
RJ: ”Now, my I-O question: this is a question about indications in combination with bavituximab. We did see pretty good data with AstraZeneca’s combination with PD-L1 [???] and their own CTLA-4 in mesothelioma and NCSLC. In fact, they do have orphan disease status and fast track with the FDA combining a CTLA-4 and a PD-L1, and these are PD-L1 low expressing tumors. So, extending into the rationale behind bavituximab also showing efficacy in PD-L1/ PD-L1 low tumors, is there a plan, given that data you're looking at, the PD-L1 approaches, and I think that some of the work was done by Scott Antonio, who's also an advisor to Peregrine. Is there a plan to move beyond, just NSCLC in combination with PD-L1 and in other PD-L1 low expressing tumors?”
Steve King: Absolutely, that’s really part & parcel of what we think we can do through all of our collaborators, AstraZeneca, the NCCN, Sloan Kettering, and UTSW, is to look at other indications. We’ve generated some interesting data earlier in liver cancer and other solid tumor types, so the opportunity to go into some of those indications where there is still clearly a high unmet medical need and patients not responding as well as everyone would like to the immuno therapy. So, we see a lot of opportunity in multiple indications outside of lung cancer, because we also recognize that lung cancer is becoming a crowded space and as you put more & more drug and drug combinations into the system, where is that an approvable indication? Now, the one benefit we think we will have in a durva, or any other PD-1/PD-L1 inhibitor, combination with bavi, is potentially on the safety side, and that really could pay dividends, because you can keep patients on treatment longer and you may be able to enhance that activity even further. So, that’s some of the things that we want to explore. First & foremost, which patients are going to respond the best, and then it's which indications or which tumor types we think then there's areas of opportunity. We want to simultaneously approach those 2 questions, and piece it together through small studies, generate good data, and then really expand it out from there - that really creates our value opportunity. The CTLA-4 + durva results are very good, but as with all of the other CTLA-4 combos of PD-1/PD-L1 inhibitors, there are significant toxicities and we think that’s where there could be an opportunity in the marketplace for safer combinations that have at least the same or maybe even greater activity.
RJ: ”Are there discussions in conjunction with AstraZeneca, or others, to address other tumors that are PD-L1 low, where conventional checkpoint inhibitors don’t work, or is this just an inate Peregrine-driven effort?”
Steve King: There is definitely the interest, clearly, in some of the other tumor types that haven’t historically responded as well to the I-O agents; breast cancer for instance, but there are other examples where we think bavi does have activity, and we want to see if we can take advantage of that from a 'priming the system', if you will, to be able to keep that immune response going with the PD-1/PD-L1 inhibitors. Yes, that’s definitely a big topic of interest is how do we, not just continue to add on and add on in lung cancer, but how do we actually get more and more tumor types to respond, and we think we can have a good role there and that’s one of the things we want to explore, either through the AZ basket study or even through some of the other collaborations we have ongoing.
5. Joe Pantginis FOLLOWUP – Roth Capital Partners: [ http://www.roth.com ]
JP: ”To George’s earlier question, how much bavi you have in your stores right now? And what’s the shelf life?”
Steve King: I don’t think we have any public information there, but we have more than enough in supply to basically be able to run all the studies we are talking about through NCCN or with our other collaborator, AZ. So drug supply will not be an issue, which is good because that offers us more capacity for the clients over in the Myford facility. So, that’s all positive at this point. With regard to the shelf life, our goal, as with any commercial product, is multiple years of stability in the bulk stage and then multiple years in the final vial, so, you end up with a lot of shelf life at the end of the day. That's helpful now, and it’s very helpful once you get to the commercial phase.
JP: ”Can you just remind us with regard to the current terms if you will with AstraZeneca, are they supplying durvalumab free of charge?”
Steve King: Yes, they are.
6. Joseph Tascalusia (sp???)
”This is a follow-up to Mr. Pantginis’ question. Is there a plan in place to possibly restructure expenses to more closely align with the Avid revenues, because it would suddenly appear with the stock price at $.40 that the ATM is no longer a viable option?”
Steve King: We are looking at the overall program. #1, we want to continue to grow revenues on the Avid side of the business. So that’s good, more money that’s coming in. On the expense side of things, we’ve already put on hold the other chemotherapy combination studies which were planned to be a significant part of our go-forward strategy, and still may be in the future, we need just more data from the SUNRISE study and then we can reevaluate. But, in the mean time, the concept is we want to be very efficient; the collaborations such as NCCN are very efficient from a cash utilization standpoint. The types of studies we run with AZ, we want to really gear those toward answering specific questions, maybe in a smaller format, which does 2 things: one it allows us to quickly generate data, but then to grow those studies, if you will, based on positive results, and positive results are going to have an impact on the market perception of the drug and what our value is. And so, we want to really take a step-wise approach, but I think we can generate good positive data without running huge hundreds and hundreds of patient studies, but really go through small studies, build on success and then use that as a springboard to even bigger studies with the idea being that, at that point, partners can jump in to help us run those studies. I think the market will respond to positive data in showing that we have good potential with the PD-1/PD-L1 inhibitor-class of drugs.
MR. KING’S CLOSING COMMENTS:
Okay, I’d like to thank again all of you for participating in today’s phone call. As always, I want to thank our stockholders for their continued support, and I would like to especially thank patients, their families and the investigators that are participating in our bavituximab clinical trials. With that, we will conclude the call.
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12-10-15 PR: ”Peregrine Pharmaceuticals Reports Financial Results for 3rd Qtr of FY 2016 and Recent Developments”
--Company Focused on Advancing Its Bavituximab Immuno-Oncology Program Through Its Pharmaceutical, Academic and Clinical Collaborations
--Full FY 2016 Revenue From Biomanufacturing Business, Avid Bioservices, Expected to Top $40 Million
--New State-of-the-Art Production Facility Commissioned and Ready for GMP Manufacturing Expands Revenue Potential
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=959623
TUSTIN, March 9, 2016: Peregrine Pharmaceuticals, Inc. (PPHM) (PPHMP), a biopharmaceutical company focused on developing therapeutics to stimulate the body's immune system to fight cancer, today announced financial results for the third quarter of fiscal year (FY) 2016 ended January 31, 2016, and provided an update on its advancing clinical pipeline and other corporate developments.
HIGHLIGHTS SINCE OCTOBER 31, 2015
“Earlier this week, we announced the commissioning of our new commercial biomanufacturing facility, which gives us significant revenue growth potential over the short term. This represented a key corporate milestone and we are continuing to evaluate a number of additional opportunities to further expand this important, revenue-generating business,” stated Steven W. King, President and CEO of Peregrine. “On the drug development side, we unfortunately experienced a recent setback with the early discontinuation of our SUNRISE Phase III study evaluating the combination of bavituximab and chemotherapy. While we continue to collect patient follow-up data in the SUNRISE study and work to better understand the final trial outcome, we have made the decision to put a hold on our other chemotherapy combination trials so that we can make an informed decision on how to potentially proceed.”
Mr. King continued, “In the meantime, we remain enthusiastic about the potential of combining bavituximab with other immuno-oncology (“I-O”) agents based on a significant amount of translational and preclinical data demonstrating that bavituximab has the potential to enhance the activity of checkpoint inhibitors. These I-O combinations are based on completely different mechanistic synergies than the chemotherapy combinations and the interest in pursuing this development pathway remains high. We are in the process of engaging all of our collaborators to formulate a comprehensive clinical strategy for exploring the potential of bavituximab with immune checkpoint inhibitors, such as PD-L1 and PD-1 inhibitors. The overall goal of these efforts is to generate important clinical data that will guide the program toward the specific patient populations that can realize the biggest benefit from these I-O combination treatments.”
CLINICAL DEVELOPMENT HIGHLIGHTS
Peregrine is working closely with its collaborators and key opinion leaders (“KOLs”) to transition the company’s clinical program to focus on bavituximab combinations with I-O agents. Peregrine’s partners and advisors, including AstraZeneca, Memorial Sloan Kettering Cancer Center, the National Comprehensive Cancer Network (NCCN) and the University of Texas, Southwestern, are leaders in the field of immuno-oncology, and their collective guidance will play an important role in the program. Activities in this area include:
Peregrine and AstraZeneca are currently evaluating the trial designs for the two previously announced clinical trials combining bavituximab with AstraZeneca’s PD-L1 inhibitor, durvalumab. In light of the recent development in the SUNRISE trial, the companies are currently working together to identify the optimal path forward for demonstrating potential mechanistic synergies between bavituximab and durvalumab in different patient populations. The expected timing of initiation of any trial will be determined upon finalization of its trial design.
Peregrine entered into a new research collaboration with the NCCN to expand upon the company's clinical development program of bavituximab in combination with immuno-oncology agents for the treatment of a range of tumors. NCCN is a not-for-profit alliance of 26 of the world's leading cancer centers dedicated to improving the quality, effectiveness, and efficiency of cancer care. Peregrine will fund multiple investigator-initiated clinical and correlative studies with bavituximab in multiple cancers at NCCN Member Institutions and their affiliate community hospitals through a $2 million research grant to NCCN's Oncology Research Program (ORP). NCCN will be responsible for oversight and monitoring of the clinical studies through the research grant.
SUPPORTIVE RESEARCH HIGHLIGHTS
Positive results were presented at the 2015 annual meeting of the Society for Immunotherapy of Cancer (SITC) from multiple new preclinical studies demonstrating enhanced anti-tumor activity and immune activation for combinations of a preclinical bavituximab equivalent and checkpoint inhibitors such as anti-PD-1 and anti-CTLA-4 in preclinical models of breast cancer and melanoma. Additionally, the company announced preliminary results for a new clinical test specifically designed to illustrate how bavituximab modulates immune responses in the tumor microenvironment.
AVID BIOSERVICES HIGHLIGHTS
“The Avid business grew 20% in FY 2015 to $26.7 million in revenue, and is expected to top $40 million in revenue for the current FY ending April 30, 2016,” stated Paul Lytle, CFO of Peregrine. “Our new state-of-the-art, 40,000 square foot commercial biomanufacturing facility, which was recently formally commissioned, is outfitted with cutting-edge, single-use equipment to accommodate a fully disposable biomanufacturing process for late Phase III clinical and commercial production of biologics. Demand for this new production capacity is high and we already have manufacturing commitments for products to be delivered in FY 2017. With demand expected to grow, we are actively considering options for potentially adding more production capacity to support additional growth of this business.”
Avid’s new state-of-the-art commercial biomanufacturing suite has been formally commissioned. The new facility will double the company’s prior manufacturing capacity, supporting up to an additional $40 million in revenue each year. As of February 1, 2016, Avid Bioservices had a revenue backlog in excess of $58 million under committed contracts from existing clients, covering services to be completed in the fourth quarter of FY 2016 and into FY 2017.
FINANCIAL RESULTS
Total revenues for the third quarter of FY 2016 were $6,709,000, compared to $5,677,000 for the same quarter of the prior fiscal year. The increase was attributed to an increase in contract manufacturing revenue generated from Avid Bioservices. Contract manufacturing revenue from Avid's clinical and commercial biomanufacturing services provided to its third-party clients for the third quarter FY 2016 were $6,672,000, compared to $5,677,000 for the same quarter of the prior FY. Peregrine expects third-party contract manufacturing revenue for the entire FY to exceed $40 million. In addition to providing biomanufacturing services to its third-party clients, Avid will continue to support the clinical manufacturing of bavituximab.
Total costs and expenses in the third quarter of FY 2016 were $23,576,000, compared to $18,699,000 in the third quarter of FY 2015. This increase was primarily attributable to current quarter increases in research and development expenses associated with the increase in manufacturing costs associated with bavituximab, the planned Phase II immuno-oncology combination trial of bavituximab and durvalumab in NSCLC, the Phase II chemotherapy combination trial in breast cancer that was initiated in December 2015 and recently placed on hold, and an increase in the cost of contract manufacturing associated with higher reported revenue. For the third quarter of FY 2016, research and development expenses were $15,156,000, compared to $11,261,000 for the third quarter of FY 2015. For the third quarter of FY 2016, cost of contract manufacturing was $3,896,000, compared to $3,113,000 for the third quarter of FY 2015. Selling, general and administrative expenses were $4,524,000 for the third quarter of FY 2016 compared to the $4,325,000 for the third quarter of FY 2015.
Peregrine's consolidated net loss attributable to common stockholders was $18,227,000, or $.08 per share [Op-Burn: 15,086,000 - see 10-Q p.27], for the 3rd quarter of FY 2016, compared to a net loss attributable to common stockholders of $14,027,000, or $0.08 per share, for the same prior year quarter.
Peregrine reported $67,470,000 in cash and cash equivalents as of January 31, 2016 compared to $68,001,000 at fiscal year ended April 30, 2015.
More detailed financial information and analysis may be found in Peregrine's Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today. [ http://tinyurl.com/hdgto9y ]
CONFERENCE CALL
Peregrine will host a conference call and webcast this morning, March 9, 2016, at 11:30AM ET (8:30AM PT). To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Peregrine Pharmaceuticals conference call. To listen to the live webcast, or access the archived webcast, please visit: http://ir.peregrineinc.com/events.cfm .
ABOUT PEREGRINE PHARMACEUTICALS, INC.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company developing therapeutics to stimulate the body's immune system to fight cancer. The company is focused on evaluating its lead immunotherapy candidate, bavituximab, in combination with a range of novel immuno-oncology (I-O) agents for the treatment of various cancers. In addition to its drug development programs, Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com ), which provides development and biomanufacturing services for both Peregrine and third-party customers. For more information, please visit http://www.peregrineinc.com .
ABOUT AVID BIOSERVICES
Avid Bioservices provides a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With over 15 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, Avid's services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support. The company also provides a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. For more information about Avid, please visit http://www.avidbio.com .
Safe Harbor *snip*
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
THREE MONTHS ENDED NINE MONTHS ENDED
JANUARY 31, JANUARY 31,
2016 2015 2016 2015
REVENUES:
Contract manufacturing revenue $ 6,672,000 $ 5,677,000 $ 25,574,000 $ 17,436,000
License revenue 37,000 - 329,000 37,000
Total revenues 6,709,000 5,677,000 25,903,000 17,473,000
COSTS AND EXPENSES:
Cost of contract manufacturing 3,896,000 3,113,000 13,245,000 10,835,000
Research and development 15,156,000 11,261,000 43,264,000 31,465,000
Selling, general and administrative 4,524,000 4,325,000 13,839,000 13,503,000
Total costs and expenses 23,576,000 18,699,000 70,348,000 55,803,000
LOSS FROM OPERATIONS (16,867,000 ) (13,022,000 ) (44,445,000 ) (38,330,000 )
OTHER INCOME (EXPENSE):
Interest and other income 34,000 29,000 691,000 108,000
Interest and other expense (14,000 ) (1,000 ) (14,000 ) (1,000 )
Total other income (expense), net 20,000 28,000 677,000 107,000
NET LOSS $ (16,847,000 ) $ (12,994,000 ) $ (43,768,000 ) $ (38,223,000 )
COMPREHENSIVE LOSS $ (16,847,000 ) $ (12,994,000 ) $ (43,768,000 ) $ (38,223,000 )
Series E preferred stock accumulated dividends (1,380,000 ) (1,033,000 ) (3,448,000 ) (2,577,000 )
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS $ (18,227,000 ) $ (14,027,000 ) $ (47,216,000 ) $ (40,800,000 )
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:
Basic and Diluted 227,389,225 182,519,923 209,549,670 180,562,524
BASIC AND DILUTED LOSS PER COMMON SHARE $ (0.08 ) $ (0.08 ) $ (0.23 ) $ (0.23 )
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
JANUARY 31,
2016 APRIL 30,
2015
Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 67,470,000 $ 68,001,000
Trade and other receivables, net 8,599,000 3,813,000
Inventories 15,189,000 7,354,000
Prepaid expenses and other current assets, net 2,346,000 1,355,000
Total current assets 93,604,000 80,523,000
Property and equipment, net 23,846,000 15,124,000
Other assets 1,602,000 1,817,000
TOTAL ASSETS $ 119,052,000 $ 97,464,000
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable $ 7,844,000 $ 10,385,000
Accrued clinical trial and related fees 6,975,000 3,910,000
Accrued payroll and related costs 4,497,000 4,606,000
Deferred revenue 15,418,000 6,630,000
Customer deposits 22,433,000 11,363,000
Other current liabilities 1,047,000 437,000
Total current liabilities 58,214,000 37,331,000
Deferred rent, less current portion 905,000 1,098,000
Commitments and contingencies
STOCKHOLDERS’ EQUITY:
Preferred stock – $0.001 par value; authorized 5,000,000 shares; 1,577,440 and 1,574,764 shares issued and outstanding at January 31, 2016 and April 30, 2015, respectively 2,000 2,000
Common stock – $0.001 par value; authorized 500,000,000 shares; 232,231,242 and 193,346,627 shares issued and outstanding at January 31, 2016 and April 30, 2015, respectively 232,000 193,000
Additional paid-in capital 557,091,000 512,464,000
Accumulated deficit (497,392,000 ) (453,624,000 )
Total stockholders’ equity 59,933,000 59,035,000
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 119,052,000 $ 97,464,000
CONTACTS:
• Jay Carlson Peregrine Pharmaceuticals, Inc. 800-987-8256 info@peregrineinc.com
• Stephanie Diaz (Investors) Vida Strategic Partners 415-675-7401 sdiaz@vidasp.com
• Tim Brons (Media) Vida Strategic Partners 415-675-7402 tbrons@vidasp.com
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[ From 10-Q header: “As of Mar. 8 2016, there were 233,738,426 shares outstanding.”
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Latest 10K 4-30-15 iss. 7-14-15 http://tinyurl.com/ocrtkuj PR: http://tinyurl.com/nw2v5u6 (Cash 4-30-15=$68.0mm)
Latest 10Q 1-31-16 iss. 3-9-16 http://tinyurl.com/hdgto9y PR: http://tinyurl.com/gom7md5 (Cash 1-31-16=$67.5mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
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Updated PPHM REVS-BY-QTR TABLE, now thru FY16'Q3(qe 1-31-16), per the 1-31-16 10-Q ( http://tinyurl.com/hdgto9y ) issued 3-9-16.
• Total Revs since May’06: ($154.8mm/Avid + $24.1mm/Govt + $2.5mm/Lic.) = $181.4mm
• 3-9-16: FY'16 (May'15-Apr'16) Avid revs guidance raised from $35-40mm to “over $40mm”.
• Deferred-Revs at 1-31-16 total $15.4mm, UP from $9.7mm at 10-31-15.
• Cust.Deposits at 1-31-16 total $22.4mm, UP from $14.9mm at 10-31-15.
• Inventories at 1-31-16 total $15.2mm, UP from $12.6mm at 10-31-15.
• Avid’s Gross-Profit over last 3 qtrs: $12.3mm on revs of $25.6mm (GP%=48%)
• Recall, Avid Rev$ from Gov’t DTRA Contract work (6/30/08 – 4/15/11, totaling $24.15mm), went into GOVT-REVS, not AVID-REVS, in the Financials.
Avid’s website: http://www.avidbio.com
AVID PROFITABILITY (GROSS*) BY QTR:
QTR Avid-Rev$ CostofMfg$ Gross-Profit$ GP%
FY13Q1 7-31-12 4,135,000 2,024,000 2,111,000 51%
FY13Q2 10-31-12 6,061,000 3,703,000 2,358,000 39%
FY13Q3 1-31-13 6,961,000 3,651,000 3,310,000 47%
FY13Q4 4-30-13 4,176,000 3,217,000 959,000 23%
FY14Q1 7-31-13 4,581,000 2,670,000 1,911,000 42%
FY14Q2 10-31-13 7,354,000 4,195,000 3,159,000 43%
FY14Q3 1-31-14 3,885,000 2,416,000 1,469,000 38%
FY14Q4 4-30-14 6,474,000 3,829,000 2,645,000 41%
FY15Q1 7-31-14 5,496,000 3,583,000 1,913,000 35%
FY15Q2 10-31-14 6,263,000 4,139,000 2,124,000 34%
FY15Q3 1-31-15 5,677,000 3,113,000 2,564,000 45%
FY15Q4 4-30-15 9,308,000 4,758,000 4,550,000 49%
FY16Q1 7-31-15 9,379,000 4,608,000 4,771,000 51%
FY16Q2 10-31-15 9,523,000 4,741,000 4,782,000 50%
FY16Q3 1-31-16 6,672,000 3,896,000 2,776,000 42%
FY13 TOTAL: 21,333,000 12,595,000 8,738,000 41%*
FY14 TOTAL: 22,294,000 13,110,000 9,184,000 41%*
FY15 TOTAL: 26,744,000 15,393,000 11,151,000 42%*
*Avid Net-Profit (ie, incl. Selling, G&A) not split out from PPHM-Corp. in the financials.
.
PPHM REVENUES (in thousands) DEFERRED
-------REVENUES------- REVENUES INVEN-
Quarter Avid Govt Lic. TOTAL Avid Govt TORIES
FY07Q1 7-31-06 398 0 23 421 317 0 971
FY07Q2 10-31-06 636 0 48 684 1388 0 1899
FY07Q3 1-31-07 347 0 16 363 2202 0 1325
FY07Q4 4-30-07 2111 0 129 2240 1060 0 1916
FY08Q1 7-31-07 1621 0 4 1625 1820 0 2363
FY08Q2 10-31-07 1863 0 29 1892 1338 0 3500
FY08Q3 1-31-08 1662 0 13 1675 1434 0 2394
FY08Q4 4-30-08 751 0 150 901 2196 0 2900
FY09Q1 7-31-08 1193 324 0 1517 4021 980 4628
FY09Q2 10-31-08 983 958 0 1941 6472 1701 6700
FY09Q3 1-31-09 5778 1048 0 6826 4805 3262 5547
FY09Q4 4-30-09 5009 2683 175 7867 3776 3871 4707
FY10Q1 7-31-09 2070 4671 9 6750 5755 2332 6177
FY10Q2 10-31-09 5308 1510 78 6896 4260 3989 5850
FY10Q3 1-31-10 2945 6854 78 9877 3052 76 3861
FY10Q4 4-30-10 2881 1461 78 4420 2406 78 3123
FY11Q1 7-31-10 983 2111 115 3209 3719 47 4692
FY11Q2 10-31-10 3627 966 78 4671 2447 35 3555
FY11Q3 1-31-11 1922 882 79 2883 4300 40 3915
FY11Q4 4-30-11 1970 681 78 2729 5617 0 5284
FY12Q1 7-31-11 5439 0 216 5655 4145 0 4481
FY12Q2 10-31-11 4154 0 78 4232 2012 0 3178
FY12Q3 1-31-12 3203 0 78 3281 2552 0 2722
FY12Q4 4-30-12 1987 0 78 2065 3651 0 3611
FY13Q1 7-31-12 4135 0 116 4251 6056 0 5744
FY13Q2 10-31-12 6061 0 78 6139 6221 0 5426
FY13Q3 1-31-13 6961 0 78 7039 5061 0 4635
FY13Q4 4-30-13 4176 0 78 4254 4171 0 4339
FY14Q1 7-31-13 4581 0 107 4688 4164 0 5679
FY14Q2 10-31-13 7354 0 0 7354 3468 0 4033
FY14Q3 1-31-14 3885 0 0 3885 4329 0 5224
FY14Q4 4-30-14 6474 0 0 6474 5241 0 5530
FY15Q1 7-31-14 5496 0 0 5496 4670 0 5998
FY15Q2 10-31-14 6263 0 37 6300 3612 0 5379
FY15Q3 1-31-15 5677 0 0 5677 5752 0 6148
FY15Q4 4-30-15 9308 0 0 9308 6630 0 6148
FY16Q1 7-31-15 9379 0 292 9671 8291 0 10457
FY16Q2 10-31-15 9523 0 0 9523 9688 0 12554
FY16Q3 1-31-16 6672 0 37 6709 15418 0 15189
Totals: 154786 24149 2453 181388 <=since5/1/2006
.
TOTAL REV’s BY YEAR (Avid+Gov’t+Lic):
FY04 4-30-04 3,314 …Avid(CMO)= 3,039 (Avid-Revs don’t incl. Govt-SVCS)
FY05 4-30-05 4,959 …Avid(CMO)= 4,684
FY06 4-30-06 3,193 …Avid(CMO)= 3,005
FY07 4-30-07 3,708 …Avid(CMO)= 3,492
FY08 4-30-08 6,093 …Avid(CMO)= 5,897
FY09 4-30-09 18,151 …Avid(CMO)= 12,963
FY10 4-30-10 27,943 …Avid(CMO)= 13,204
FY11 4-30-11 13,492 …Avid(CMO)= 8,502
FY12 4-30-12 15,233 …Avid(CMO)= 14,783
FY13 4-30-13 21,683 …Avid(CMO)= 21,333
FY14 4-30-14 22,401 …Avid(CMO)= 22,294
FY15 4-30-15 26,781 …Avid(CMO)= 26,744
...Total Gov’t Revs from 7-2008 inception thru FY11Q1(Apr’11): $24.15mm
.
PPHM’S QTLY. NET LOSS BY QTR:
FY08Q1 7-31-07 4,656,000
FY08Q2 10-31-07 6,207,000
FY08Q3 1-31-08 6,154,000
FY08Q4 4-30-08 6,159,000
FY09Q1 7-31-08 5,086,000
FY09Q2 10-31-08 4,497,000
FY09Q3 1-31-09 3,332,000
FY09Q4 4-30-09 3,609,000
FY10Q1 7-31-09 2,428,000
FY10Q2 10-31-09 2,787,000
FY10Q3 1-31-10 1,538,000
FY10Q4 4-30-10 7,741,000
FY11Q1 7-31-10 7,695,000
FY11Q2 10-31-10 7,513,000
FY11Q3 1-31-11 8,929,000
FY11Q4 4-30-11 10,014,000
FY12Q1 7-31-11 8,092,000
FY12Q2 10-31-11 12,055,000
FY12Q3 1-31-12 11,090,000
FY12Q4 4-30-12 10,882,000
FY13Q1 7-31-12 7,664,000
FY13Q2 10-31-12 8,753,000
FY13Q3 1-31-13 4,914,000
FY13Q4 4-30-13 8,449,000
FY14Q1 7-31-13 7,600,000
FY14Q2 10-31-13 7,790,000
FY14Q3 1-31-14 9,724,000
FY14Q4 4-30-14 10,248,000
FY15Q1 7-31-14 13,129,000
FY15Q2 10-31-14 12,100,000
FY15Q3 1-31-15 12,994,000
FY15Q4 4-30-15 12,135,000
FY16Q1 7-31-15 13,723,000
FY16Q2 10-31-15 13,198,000
FY16Q3 1-31-16 16,847,000
= = = = = = = =
OPER. CASH BURNS* BY QTR(FROM THE 10-Q/K’S):
FY10Q1 7-31-09 2,024,000 (from 10Q pg.25)
FY10Q2 10-31-09 2,351,000 (Q1+Q2: 4,375,000 pg.28)
FY10Q3 1-31-10 1,158,000 (Q1+Q2+Q3: 5,533,000 pg.30)
FY10Q4 4-30-10 6,375,000 (FY’10: 11,908,000 10K pg.58)
FY11Q1 7-31-10 6,567,000 (from 10Q pg.24)
FY11Q2 10-31-10 6,167,000 (Q1+Q2: $12,734,000 pg.25)
FY11Q3 1-31-11 7,736,000 (Q1+Q2+Q3: $20,470,000 pg.26)
FY11Q4 4-30-11 8,961,000 (FY’11: 29,431,000 10K pg.54)
FY12Q1 7-31-11 6,984,000 (from 10Q pg.25)
FY12Q2 10-31-11 11,668,000 (Q1+Q2: 18,652,000 pg.25)
FY12Q3 1-31-12 8,490,000 (Q1+Q2+Q3: 27,142,000 pg.25)
FY12Q4 4-30-12 11,265,000 (FY’12: 38,407,000 10K pg.55)
FY13Q1 7-31-12 6,742,000 (from 10Q pg.21)
FY13Q2 10-31-12 6,162,000 (Q1+Q2: 12,904,000 pg.23)
FY13Q3 1-31-13 3,597,000 (Q1+Q2+Q3: 16,501,000 pg.23)
FY13Q4 4-30-13 7,053,000 (FY’13: 23,554,000 10K pg.60)
FY14Q1 7-31-13 5,750,000 (from 10Q pg.23)
FY14Q2 10-31-13 5,834,000 (Q1+Q2: 11,584,000 10Q pg.24)
FY14Q3 1-31-14 7,875,000 (Q1+Q2+Q3: 19,459,000 10Q pg.26)
FY14Q4 4-30-14 8,706,000 (FY’14: 28,165,000 10K pg.55)
FY15Q1 7-31-14 11,076,000 (from 10Q pg.23)
FY15Q2 10-31-14 9,947,000 (Q1+Q2: 21,023,000 10Q pg.25)
FY15Q3 1-31-15 11,116,000 (Q1+Q2+Q3: 32,139,000 10Q pg.26)
FY15Q4 4-30-15 10,474,000 (FY’15: 42,613,000 10K pg.54)
FY16Q1 7-31-15 12,306,000 (from 10Q pg.25)
FY16Q2 10-31-15 11,701,000 (Q1+Q2: 24,007,000 10Q pg.26)
FY16Q3 1-31-16 15,086,000 (Q1+Q2+Q3: 39,093,000 10Q pg.27)
FY’09 total Op-Burn: $14,715,000
FY’10 total Op-Burn: $11,908,000
FY’11 total Op-Burn: $29,431,000
FY’12 total Op-Burn: $38,407,000
FY’13 total Op-Burn: $23,554,000
FY’14 total Op-Burn: $28,165,000
FY’15 total Op-Burn: $42,613,000
*The 10-Q’s define OPER.BURN as, ”Net cash used in operating activities before chgs. in operating assets & liabilities”.
The 7-21-2001 10Q explains OP.BURN very nicely:
“RESULTS OF OPERATIONS. Before we discuss the Company's total expenses (cash & non-cash expenses), we would like to discuss the Company's operational burn rate (cash expenses used in operations, net of interest and other income) for q/e July 31, 2001 compared to the same period in the prior year. The operational burn rate is calculated by taking the net income (loss) from operations and subtracting all non-cash items, such as the recognition of deferred license revenue, depreciation and amortization and stock-based compensation expense.”
Q/E Halozyme Cust-A/U.S. Other-Custs
4-30-14 91% 1% 8%
4-30-15 79% 12% 9%
7-31-15 84% 15% 1%
10-31-15 56% 41% 3%
1-31-16 64% 27% 9%
- - - - - - - - PPHM’s Fiscal Qtr’s (FY runs May – April):
FY’10-Q3 = q/e 1-31-10 – rep. 3-11-10 Thu (B4 mkt)
FY’10-Q4 = q/e 4-30-10 – rep. 7-14-10 Wed (after mkt)
FY’11-Q1 = q/e 7-31-10 – rep. 9-9-10 Thu (after mkt)
FY’11-Q2 = q/e 10-31-10 – rep. 12-9-10 Thu (after mkt)
FY’11-Q3 = q/e 1-31-10 – rep. 3-11-11 Fri (after mkt)
FY’11-Q4 = q/e 4-30-11 – rep. 7-14-11 Thu (after mkt)
FY’12-Q1 = q/e 7-31-11 – rep. 9-9-11 Fri (B4 mkt)
FY’12-Q2 = q/e 10-31-11 – rep. 12-12-11 Mon (after mkt)
FY’12-Q3 = q/e 1-31-12 – rep. 3-9-12 Fri (after mkt)
FY’12-Q4 = q/e 4-30-12 – rep. 7-16-12 Mon (after mkt)
FY’13-Q1 = q/e 7-31-12 – rep. 9-10-12 Mon (B4 mkt)
FY’13-Q2 = q/e 10-31-12 – rep. 12-10-12 Mon (after mkt)
FY’13-Q3 = q/e 1-31-13 – rep. 3-12-13 Tue (after mkt)
FY’13-Q4 = q/e 4-30-13 – rep. 7-11-13 Thu (after mkt)
FY’14-Q1 = q/e 7-31-13 – rep. 9-9-13 Mon (after mkt)
FY’14-Q2 = q/e 10-31-13 – rep. 12-10-13 Tue (after mkt)
FY’14-Q3 = q/e 1-31-14 – rep. 3-7-14 Fri (B4 mkt)
FY’14-Q4 = q/e 4-30-14 – rep. 7-14-14 Mon (after mkt)
FY’15-Q1 = q/e 7-31-14 – rep. 9-9-14 Tue (after mkt)
FY’15-Q2 = q/e 10-31-14 – rep. 12-10-14 Wed (after mkt)
FY’15-Q3 = q/e 1-31-15 – rep. 3-12-15 Thu (after mkt)
FY’15-Q4 = q/e 4-30-15 – rep. 7-14-15 Tue (after mkt)
FY’16-Q1 = q/e 7-31-15 – rep. 9-9-15 Wed (after mkt)
FY’16-Q2 = q/e 10-31-15 – rep. 12-10-15 Thu (after mkt)
FY’16-Q3 = q/e 1-31-16 – rep. 3-9-16 Thu (B4 mkt)
= = = = = = = = = = = =
“Going Concern” statement ELIMINATED from 4-30-13 10-K issued 7-11-2013…
2012: 4-30-12 10-K iss. 7-16-12 http://tinyurl.com/79o57b2
Pg.68: “As more fully described in Note 2, the Company’s recurring losses from operations and recurring negative cash flows from operating activities raise substantial doubt about its ability to continue as a going concern.”
2013 & 2014 & 2015 10-K's: http://tinyurl.com/p58jcbw etc...=> ((((NO GOING CONCERN STATEMENT INCLUDED.))))
CASH a/o 4-30-13: $35.2mm
CASH a/o 6-30-13: $42.6mm
CASH a/o 7-31-13: $41.6mm
CASH a/o 10-31-13: $44.4mm
CASH a/o 1-31-14: $63.2mm
CASH a/o 2-15-14: $79.7mm
CASH a/o 4-30-14: $77.5mm
CASH a/o 6-30-14: $78.3mm
CASH a/o 7-31-14: $73.3mm
CASH a/o 10-31-14: $64.4mm
CASH a/o 1-31-15: $55.2mm
CASH a/o 4-30-15: $68.0mm
CASH a/o 7-31-15: $59.0mm
CASH a/o 10-31-15: $72.0mm
CASH a/o 1-31-16: $67.5mm
= = = = = = = = = = A look at #Employees per the 10K’s…
2011 10-K: "As of 4-30-11, we employed 154 full-time emps & 2 part-time emps”
2012 10-K: "As of 4-30-12, we employed 172 full-time emps & 2 part-time emps."
2013 10-K: "As of 4-30-13, we employed 182 full-time emps & 5 part-time emps."
2014 10-K: "As of 4-30-14, we employed 180 full-time emps & 4 part-time emps."
2015 10-K: "As of 4-30-15, we employed 211 full-time emps & 4 part-time emps."
= = = = = = = = = = = = = = = = = =
3-7-16: Formal Commissioning of Avid's 40,000sq Expansion, “single-use/fully disposable” (potentially $40M addl revs) http://tinyurl.com/za2j9mt
...12-10-15: Avid Expansion into MYFORD Facility (Avid II) now GMP-run ready (potential +$40mm sales) - contemplating further expansion http://tinyurl.com/z35623w
1-18-16: CEO Steve King's 1-18-16 presentation at Noble-Financial's Investor Conf. (21min replay, 31 slides) http://tinyurl.com/j9dkekm
1-11-16: Update on 4 New Bavi Clinical Trials (Lung/AZN, Breast/1Co./1MSKCC, Other Cancers/AZN). SUNRISE est's: Look1=Early'16, Look2=Mid'16, FinalUnblind=End'16 http://tinyurl.com/zhdy37a
1-6-16: Peregrine enters into Research Collab. with Natl-Comprehensive-Cancer-Network (NCCN) http://tinyurl.com/zmxtpsb
...$2mm res. grant to NCCN's Oncology Res. Pgm (ORP), will “significantly expand our clinical evaluation of Bavi and augment Peregrine's IST pgm at 26 of the world's leading cancer centers”.
12-10-15 Qtly. Conf. Call (King/Shan/Worsley/Garnick/Lytle) Transcript http://tinyurl.com/jkp885g
...CEO SK: “Although our SUNRISE enrollment milestone has been reached, we have no intention of slowing down, quite the opposite. We are aggressively moving to initiate new clinical trials [Lung, Breast, Mult-Types] that will allow us to build the most robust oncology business possible… With each of these studies our goal is the same - we are committed to identifying key indications, patient populations, and therapeutics that can benefit from combination treatment with bavituximab. From what we have seen to-date, the opportunity appears vast and we are hard at work converting the most promising prospects into true value.”
10-15-15 Peregrine's ASM: ATTENDEE Reports & Link to SK's 18min/16slide webcast: http://tinyurl.com/o6z4bm4
10-15-15: Peregrine & AstraZeneca Expand Collab. w/Ph2/2ndLine-NSCLC Trial, Bavi+durvalumab(MEDI4736), squamous or non-squamous. http://tinyurl.com/q79bkam
8-24-15: AstraZeneca & Peregrine Collaborate on Bavi+Durvalumab Ph1/1B Trial for “multiple solid tumors” http://tinyurl.com/owlxpsf
...Durvalumab=MEDI4736(anti-PD-L1 immune checkpoint inhibitor). AZN’s Head/I-O(Robert Iannone): “Our partnership with Peregrine provides the opportunity to explore an exciting, novel combination that could deliver important clinical benefit to patients across a range of cancers."
5-29-15: Peregrine & Sloan Kettering Enter Collab. to “Investigate Novel PS-Targeting Immunotherapy Combos” http://tinyurl.com/qxu4w2x
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