Friday, December 11, 2015 5:39:59 PM
12-10-15 Qtly CC-Transcript, PR(Fins/Devs Q2FY16/qe10-31-15), updated Avid Revenues History Table By Quarter…
=> Total Revs May06-Oct15: $148.1mm/Avid + $24.1mm/Govt + $2.4mm/Lic. = $174.7mm. Cash at 10-31-15: $72.0mm
As of Dec. 9, 2015, there were 229,701,808 shares outstanding.
This large post has 3 sections:
I. 12-10-15 Q2/FY16 Qtly. Earnings Conf. Call TRANSCRIPT (q/e 10-31-15)
II. 12-10-15 PPHM Press Release: Q2/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/zq52d5w ], with numerous corrections made. )))
Link to webcast replay:
http://ir.peregrineinc.com/events.cfm => http://edge.media-server.com/m/p/jigxfb5c
FULL TRANSCRIPT…
12-10-2015 FY’16/Q2 Earnings Conf. Call (q/e 10-31-15)
WELCOME & FWD-LOOKING STATEMENTS: Tim Brons, Vida Strategic Partners (IR) http://www.peregrineinc.com
Speakers: Steve King, Joe Shan, Stephen Worsley, Rob Garnick, Paul Lytle; Q&A session.
CEO STEVE KING – OPENING COMMENTS:
Thanks as always to all of you who have dialed in, and to all of you who are participating via webcast today. I’ll start by saying that we are making great progress in our broad overall development strategy for bavituximab. The strategy is to establish the potential of bavituximab in combination with current & evolving standard of care drugs, with both chemotherapy and immuno-oncology combinations in multiple cancer indications. Our goal is to drive to meaningful clinical data points in each of these areas by early 2017. In accordance, today’s development discussions will focus on these efforts, including upcoming completion enrollment in the SUNRISE trial which is evaluating a chemotherapy combination, and, as SUNRISE wraps up, our plans for a smooth transition of the key SUNRISE clinical sites directly to the next Phase II lung cancer trial evaluating an IO combination. In addition, we are expanding our potential cancer indications through initiation of a Phase II/III metastatic breast cancer study. All of this while continuing to work through several other clinical trial concepts actively under development or initiation in the new year.
On the development front, I’m pleased to report today that we are nearing completion of enrollment in the cornerstone of our bavituximab development strategy, our Phase III SUNRISE trial. In fact, with over 90% of the expected enrollment complete, we currently have sufficient patient enrollment based on the assumptions of the study to allow the trial’s planned interim evaluations and final readout based on the primary endpoint of overall survival. Having said that, we do expect to complete enrollment of at least the pre-specified 582 patients over the coming weeks. At this point, the next big milestones really are the interim data analysis from the study, expected to take place during early & mid 2016, with trial unblinding expected toward the end of 2016. Joe will add little more color to the up coming milestones for the SUNRISE trial during his prepared remarks.
For me, what has now become the most important thing at this point in our broader strategy is to engage our best enrolling sites from the SUNRISE trial toward a smooth transition to the new Phase II study that will evaluate bavi in combination with AstraZeneca’s anti-PD-L1 antibody durvalumab. We have a golden opportunity here to maintain continuity for our lung cancer program by continuing almost seamlessly working with our high enrolling sites and key investigators in essentially the same, even in extended, patient population with the inclusion of squamous non-small cell lung cancer patients. I have personally had the opportunity to meet with key investigators all over the globe and there is a lot of enthusiasm for continuing to work with Peregrine and bavituximab in the new study. Based on feedback so far, we expect that the new study could enroll even more quickly than the SUNRISE trial and the best way to ensure that is to get off to a quick start, again keeping us on track for data from the new study by early 2017. This would give us two nice sets of data in NSCLC to work with.
Equally exciting is the Phase II/III metastatic HER2- breast cancer study that we are looking forward to starting by year-end. I say exciting because the new trial design has a solid clinical data basis, and our previously completed Phase I & II trials in a patient population in these new treatment options. While we don’t have the same benefit as we do for the lung cancer program of rolling right from one study into another, the team has been working diligently to get the study started by the year-end, giving us additional enrollment months, which again can put us on track for some meaningful clinical data from the study by early 2017.
The company is also working diligently on a number of other studies, including our other collaboration with AstraZeneca, evaluating a combination of bavi with chemotherapy and adding in again their durvalumab antibody in multiple solid tumor indications. So, conceptually, “get an immune response going with chemotherapy & Bavi, and then keep it going with durvalumab”.
In addition, we are working toward initiating an earlier stage breast cancer study, as well as a number of other concepts that are in development. So, stay tuned for future clinical developments. Taken together, these clinical efforts, along with the plethora of preclinical & translation collaborations evaluating new combinations, new potential indications, and further validating our immune mechanism of action has a potential to add substantial value over the coming year. We expect a steady flow of scientific & clinical presentations over the coming year as we continue to learn to more about the potential bavituximab.
Oh, and by the way, today we also announced another record revenue quarter from our biomanufacturing business, with our new Myford manufacturing facility just ready for GMP production, which can help spur even more future growth for the business, not the least of which is getting ready for bavi commercial production. Rob & Paul will add more detail and discuss the continued growth for our mfg. business shortly. To say that these are busy times at Peregrine is an understatement.
JOE SHAN (VP/Clin.&Reg. Affairs) – CLINICAL TRIALS:
I’d like to start by quickly addressing our Phase III SUNRISE trial, which is evaluating the use of bavituximab & docetaxel in patients with previously treated locally advanced or metastatic non-squamous NSCLC. As Steve stated, we have already enrolled the number of patients required to achieve the trial’s main objectives, and expect to complete enrollment of the target sample size of 582 in the coming weeks. The next milestones are the interim analyses that will be conducted when 33% & 50% of the targeted number of deaths are reached. While these are event driven, it is our expectation that the 1st interim analysis will read out in early 2016 and the 2nd interim analysis around mid-2016. The final analysis, which will trigger study unblinding, is currently projected to occur at the end of 2016.
With the SUNRISE enrollment nearing completion, the Peregrine clinical team is shifting focus to a number of new clinical projects, including those just referenced by Steve. In each case, our goal is to generate clinical evidence of bavituximab’s ability to improve patient outcomes when combined with chemotherapy and immuno-oncology agents. With this goal in mind, we are very pleased to be collaborating with AstraZeneca. Through this partnership, we will be conducting 2 clinical trials, both of which will be initiated in 2016. One trial, which we expect to initiate early 2016, is a global randomized Phase II study in approx. 200 patients with previously treated NSCLC. This trial will evaluate the combination of bavituximab and AZ’s anti-PD-L1 immune checkpoint inhibitor durvalumab, or MEDI4736. As part of this combination trial, patients will also be evaluated retrospectively for the correlation between their PD-L1 levels & clinical outcomes. As the remaining patients are enrolled into SUNRISE, we have already begin laying the groundwork to quickly initiate this new Phase II combination study at a number of our most active sites participating in SUNRISE. These investigators are very familiar with bavituximab and have access to the appropriate patient populations, and we believe this experience will greatly benefit our new study.
The other trial with AstraZeneca will be a Phase I/Ib trial evaluating bavituximab in combination with chemotherapy & durvalumab in multiple solid tumors. The Phase I part of the trial will confirm the tolerability of the 2 IO agents and establish a recommended dose regimen for the Phase 1b part of the trial, which will assess safety & activity of the triple combination, which includes standard chemotherapy.
We’re particularly excited about these trials because we believe that bavituximab & durvalumab have different and potentially complementary mechanisms. Bavituximab, by targeting exposed PS, a highly immuno-suppressive molecule exposed on the surface of cells in the tumor microenvironment, has been shown to trigger macrophage re-polarization and tumor specific T-Cell activation. Durvalumab is a monoclonal antibody directed against programmed cell death ligand1, or PD-L1, and signals from PD-L1 help tumors avoid detection by the immune system. It’s become apparent that check inhibitors like durvalumab are most effective when there is a preexisting T-Cell response in tumors, as it provides those check inhibitors with the immune active environment they need to work best. Importantly, we have demonstrated in preclinical models the ability of bavituximab to activate CD8+ T-Cells and the anti-tumor activity PD-L1 checkpoint blockade is greatly enhanced when combined with bavituximab. Another important observation we recently made is that our PS signaling pathway inhibitors demonstrate multiple signs of immune activation in the low or negative PD-L1 tumors. We believe that this holds great potential to increase the number of patients able to respond to checkpoint therapy as well as traditional chemotherapy. Based on these observations, we believe that by combining these 2 approaches, the potential exists for a more complete & durable anti-tumor immune response. We look forward to getting both trials in our AstraZeneca collaboration underway.
Now, beyond lung cancer, we plan to initiate addl. clinical trials in breast cancer based on our clinical experience to-date. Data from a Phase I IST of bavituximab+paclitaxel published in Cancer Medicine earlier this year [3-31-15/A.Stopeck, N=13: PFS=7.3mos, ORR=85%, 2 CR's http://tinyurl.com/nm5oog4 ] demonstrated an impressive 85% response rate of patients with HER2- metastatic breast cancer. Data from this IST, together with 2 prior Peregrine-sponsored trials of bavituximab with taxane-based chemotherapy, which yielded between 61-74% response rates and a MOS of over 20mos. in patients with advanced or metastatic breast cancer, provides strong rationale to advance this indication. Importantly, taxanes continue to be a key std. treatment option for different stages of breast cancer. Accordingly, we plan to initiate a Phase II/III trial in patients with HER2- metastatic breast cancer, with all patients receiving physicians’ choice of paclitaxel or docetaxel, either alone or in combination with bavituximab. The Phase II part of the trial will enroll approx. 150 patients with a primary end point from overall response rate. The first sites in this Phase II/III breast cancer trial are scheduled to be initiated before the end of the year. Furthermore, we're planning a trial evaluating neoadjuvant paclitaxel with or without bavituximab, in the hopes of further elucidating bavituximab’s immune modulating mechanism and look for clinical signals in early stage breast cancer. That concludes my comments today I’d like to turn the call over to Steve Worsley to give an overview of business development activity.
STEPHEN WORSLEY (VP/Business Dev.):
We were very pleased to announce our collaboration with AstraZeneca in August [8-24-15: http://tinyurl.com/owlxpsf ] and were even more delighted to announce the expansion of that agreement in October [10-15-15: http://tinyurl.com/q79bkam ]. We believe that AstraZeneca’s enthusiasm for this program is based on the promise & potential of bavituximab. Copious amounts of positive data have consistently demonstrated bavituximab’s therapeutic value & ability to provide solutions to the limitations of currently available treatments. Today, checkpoint inhibitors are primarily effective in patients with high PD-L1 expression, a minority of all patients being treated. However, translational findings have demonstrated that bavituximab is effective in patients with the lowest PD-L1, PD-1 expressions, highlighting the potential bavituximab to convert patients with the low expression levels who do not respond to anti-PD-1 treatments into responders.
In addition to AstraZeneca, such data have also been the impetus for our ongoing collaboration with Memorial Sloan Kettering Cancer [5-21-15: http://tinyurl.com/qxu4w2x ], which is evaluating combinations of bavituximab with other checkpoint inhibitors & immune stimulatory agents for the purpose of developing new & increasingly effective anti-cancer treatments. It has also been the driver for our ongoing work with the Univ. of Texas SW, as well as a number of other ISTs.
Peregrine’s goal in partnering with these immuno-oncology leaders is to define the broader scope of utility for bavituximab. Through these collaborations, we are actively identifying a range of indications & treatments that will benefit from combination therapy with bavituximab. This will undoubtedly yields important findings in the near-term that will continue to build shareholder value. We continue our dialog with a number of other world leading pharmaceutical organizations and believe that bavituximab will continue to generate partnering interest. I will now turn the call over to Rob Garnick, Peregrine’s Head of Regulatory Affairs, who’ll discuss our drug mfg. & regulatory activities.
Rob Garnick (Head of Regulatory Affairs):
As we reported in our press release today, our new facility has just been commissioned for the initial phase of GMP manufacturing. I’d like to reiterate that this facility, currently named the Myford facility, is state-of-the-art and its construction was completed for a fraction of the cost of building of comparable facilities. This in and of itself is a major accomplishment and I am very proud of our team for their success in this achievement. Going forward, we expect this facility will be a highly valuable asset for Peregrine & Avid. Initial engineering runs, which will be initiated tomorrow, will be followed by GMP runs prior to process validation for products entering into the facility. GMP material produced in the new facility can be used either in clinical trials or for commercial sale once Peregrine or Avid’s business partners make the appropriate regulatory filings in the territories where they intend to use the product. This generally requires several runs and demonstrating that the product produced in the Myford facility is comparable to product produced in our Franklin facility or in other production facilities. With the Myford site now in the initial phase of GMP manufacturing, we have seen a significant increase in demand for production capacity. Although, we have just opened the doors at Myford, we are already contemplating our options to increase further mfg. capacity. Although no decisions have been made, we are pleased to have what appears to be a growing opportunity in this important area of our business.
On the regulatory side, we are busy to taking the steps necessary to initiate up the new clinical trials that Joe described. To this end, we successfully filed the new IND supporting expanding the bavituximab breast cancer program and subsequently received FDA clearance to commence the study. We have also taken important steps to de-risk our bavituximab/durvalumab combination trials by requesting and receiving critical guidelines from the FDA. It’s been a busy time for the regulatory affairs team, but our recent efforts have put us on track to grow our mfg. business and initiate our newest clinical programs. This concludes my comments and I will now turn the call over to CFO Paul Lytle, who will discuss the company’s financial performance and our Avid Bioservices business.
CFO Paul Lytle:
I’ll start with an overview of our contract mfg. business. The Avid Bioservices business continues to strengthen. During Q2, our wholly-owned subsidiary achieved record quarterly revenue of $9.5mm, a 52% increase over the same prior year qtr. Year-to-date, we recorded mfg. revenue of $18.9mm or a 61% 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. This has raised our current revenue backlog to approx. $49mm. Based on this increase in demand, we are raising our revenue guidance to $35-40mm for the full FY2016 compared to previous guidance of $30-35mm.
We also believe that business has more opportunity to grow, as our 2nd mfg. Facility [Myford Facility] has the capacity to generate approx. $40mm in new revenue. As Rob mentioned, the new facility is ready for the initial phase of GMP manufacturing to support both to manufacturing of bavituximab in addition to growing our revenue from 3rd-party customers. As I wrap up this discussion on Avid, I can’t emphasize enough the strategic importance of this business. Avid continues to generate non-dilutive income that in turn continues to offset the amount of capital we need to raise by other means, plus it’s important to note that preparing bavituximab for commercial production is a significant financial endeavor and this strategic asset saves us millions of dollars each year in mfg. costs.
Turning now to expenses, R&D expenses for Q2 increased, primarily due to increase expenses associated with our Phase III SUNRISE trial and our newly planned later stage company-sponsored trials in breast cancer & lung cancer. While G&A expenses remained relatively flat qtr-over-qtr. Lastly, during the quarter Peregrine closed a registered direct offering with a single institutional investor raising $20mm [10-30-15: Kenneth Dart (Eastern Capital) acquires 13.1% stake (30,106,945sh.) in PPHM http://tinyurl.com/24qctos ]. These funds will help support our ongoing Phase III SUNRISE trial as well as our newly planned later staged company-sponsored trials. In more detailed analysis of our statement of operations is included in our Form 10-Q that was filed today. [10Q: http://tinyurl.com/zdbo9rv ] This concludes my financial overview, I now turn the call back over to Steve to discuss some important upcoming milestones.
CEO STEVE KING – MILESTONES:
As you’ve just heard from the team, although our SUNRISE enrollment milestone has been reached, we have no intention of selling down, quite the opposite. We are aggressively moving to initiate the clinical trials that will allow us to build the most robust oncology business possible. By mid-2016, we will initiate 2 breast cancer studies, a Phase II/III trial in metastatic HER2- breast cancer and the Phase I trial in early-stage breast cancer, a new Phase II trial in lung cancer, and a Phase I/Ib trial for multiple solid tumors. These studies will set the stage for expected clinical data readouts from at least 3 trials by early 2017, our SUNRISE Phase III trial, the new Phase II NSCLC trial, as well as the Phase II breast cancer study. In addition, we have other potential data coming from ongoing ISTs, as well as the other studies that we will be initiating. 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 in the true value.
Q&A: [23:30 mark]
1. Thomas Yip (FBR & Co.): http://www.fbr.com
TY: ”….congrats on a good qtr, especially for Avid. Re: the timing of your Phase II trials in lung cancer & breast cancer, are there other advantages to follow SUNRISE so tightly than to speed up enrollment? Because, like you said, we are expecting SUNRISE unblinding in 2nd-half 2016, and then in early 2017 we’ll have 2 Ph2 readouts in lung cancer & breast cancer.”
Steve King: The goal of the new studies is to continue to build the value proposition for the overall portfolio. I think the key to success eventually commercially for bavituximab is to be able to be used in multiple lines of therapy. Clearly the SUNRISE trial represents the combination with docetaxel, a chemotherapy regiment which is going to continue to be used, and the new Phase II study will then expand that into a combination in the IO space with the combination with the PD-L1 inhibitor. Clearly, those types of drugs are going to be used as the lung cancer space continues to evolve over the coming years. And so, the more we can be a part of both those better off we are, and again it’s really a golden opportunity to enroll right from the SUNRISE trial, which is in a very similar patient population to the new trial. The new trial has some advantages in that it will actually include both squamous & non-squamous, so it increases the number of eligible patients. So, to keep those investigators engaged suddenly moving right from one SUNRISE study into another SUNRISE study is a huge advantage in building that relationship with these key investigators and KOLs in the area. The breast cancer study, this is an area we wanted to move forward in previously. We’ve had some great Phase II data, as Joe mentioned, along with the data in HER2- breast cancer patients, in which we saw a nice 85% tumor response rate. That represents as big or a bigger market potential as NSCLC. So, taken together, that really is going to add tremendous value to the program, give us multiple data readouts, and from a partnering perspective adds a lot of potential value to the program. And Steve maybe you want to expand on that a little bit from partnering perspective?
Stephen Worsley: I think the exposure that we’re seeing with these 2 collaborations [AZN & MSKCC] have significantly increased who we're talking to, but also the ability for bavituximab to act in a variety of different indications. This is obviously leading to further discussions with some of the leading oncology players worldwide.
TY: ”Will the Ph1 breast cancer trial be an IST or sponsored by Peregrine?”
Steve King: I think the Ph1 study will end up being a company-sponsored study. It will obviously be a much smaller study than the 2 Ph2's we’re talking about. But it will allow us to run at multiple institutions. There's actually a lot of interest from number of different institutions, that allows us to run a study that we think can add a lot of value, but also that we can move forward on a nice timeline that sets the stage for, within the breast cancer space, a very nice addition to the Ph2 study that we’ll be running in another big patient population represented in that trial.
TY: ”Re: your collaboration with AstraZeneca, it seems that the Ph2 cancer trial has now been accelerated ahead of the solid tumor trial. So can you remind us what the advantages of combining bavituximab w/durvalumab over your previous planned Ph2 trial combination with Opdivo?”
Steve King: The advantages are on several fronts. #1 is it really gives us the flexibility to run the study in the way we want to run the study & where we want to run it. Because otherwise, we’d have to source Nivo [Opdivo=nivolumab] or one of the other PD-1 inhibitors on a regional basis, in which the drug isn’t approved in lot of different regions where you may want to run the study. So just operationally, it gives us the freedom to more efficiently run a study and get it up & running much quicker than we otherwise would have able to. #2, it really gives us a great opportunity to potentially reduce the cost of what study otherwise would have been, because if we would have to go out and acquire the drug for a clinical study, it could as much as double the cost of the trial. So, it just all around allows us to run a much more efficient trial with the drug that’s in our discussions with the KOLs in the field, people with direct experience, they feel that the PD-L1 antibodies work at least as well as the anti-PD-1 antibodies. Our goal is to answer a key question, which is, “can bavituximab add to the activity of a PD-1/PD-L1 inhibitor?”, and this allows us doing on a timeframe. So, there are just a lot of huge advantages. I’ll end that with the fact that also we’re working with a what we think is a great partner [AstraZeneca]. They’ve been very interactive so far. They also have a lot of knowledge of PD-L1/PD-L1 status in the patients, which is one of the things we'll want to be looking at as part of both the Ph2 as well as in the other studies we run in NSCLC, as our ability to have a positive impact on potentially those PD-L1 negative tumors, which don’t typically response well the PD-1 therapy. That’s sort of one of those things that’s hard to put a numeric value to, but is a true advantage of working with a great partner.
TY: “Thanks - look forward to see you guys at JP Morgan.”
2. George Zavoico – Jones Trading http://jonestrading.com
GZ: ”Congrats on a good qtr, particularly with the Avid revenues… You mentioned the possibility of expanding Avid’s mfg. capacity further. #1, will that be without including fill & finish capability, because I think there is a probably pretty good business there as well. And #2, if you do expand, do you have space where you are now you have to expand to some other property?”
Steve King: The expansion really is driven by our existing & new clients that have come in, and so obviously primarily that’s driven in the bulk drug specimens area not necessarily the fill/finish area. So that'll probably be the primary focus; we have considered and eventually would like to move into the fill/finished business, it's just we’ve been so busy expanding our drug specimens business, we really haven’t had the option to do that. For the question of space, there’s space in the current buildings that we’re in, but we’re also looking at other opportunities nearby that fit the same model as we did for the Myford facility and allows us to most efficiently grow the business. At the end of the day it will be a business decision and we’ll take on space as needed to expand the business. Again, it’s all really right now supported by the client base, which has had an extremely positive response to the Myford facility and that’s really driving we think even beyond what we expected going into it.
GZ: ”Would you finance that further expansion as sort of debt against the revenue coming in or are you just keeping all your options open for that?”
Steve King: We’re keeping our options wide open. At this point, we’ll do what’s best for the business itself. It’s a nice growing backlog of future revenue, it’s really a change in the way the Avid business can be viewed, as more a long-term go-forward business. So, we just need to make the right business decision based on the cost of capital, whatever avenue that takes, and then we’ll make the right decision.
GZ: ”Re: SUNRISE, there have been a couple of interesting & unfortunate events with some other companies where OS in the placebo arm of a trial has been much longer than expected. What are you seeing in that regard, because SUNRISE has been going on now for about 2 years now. What kind of advances have you seen in the SOC that might either make us more confident, or maybe a little bit more worried, about the possibility of having a surprise like that?”
Steve King: I can start off and maybe Joe can add in, but when we designed the SUNRISE study we did take into account the variability that had been seen in the docetaxel studies that had been reported up to that point. I don’t think we’ve seen any really significant variations from that as over time as more readouts have come. So, that’s one thing that we did take into account, that we were toward the upper end of what have been previously reported for docetaxel. Secondly, when we powered the study, in the Ph2 study we saw about a 4mos. difference in median OS, and the SUNRISE study was designed to really show a statistical difference even at 2mos; we built in some powering assumptions we think will give us some opportunity there should be arms behave in a way that was little bit unexpected. So, we’ve tried to hedge against that going into the stage design and we think we’re in good shape and now it’s just a matter of getting the readouts - we’re little under 2yrs right now from when we started to study, so at this point there’s really nothing more we can learn from the ongoing operations of the SUNRISE trial itself.
Joe Shan: George, obviously it's a very dynamic field right now. As Steve mentioned, we tried to make the SUNRISE design in such a way that it's as homogenous as practical. We obviously have some stratification criteria built in and some preplanned, subgroup analyses that are going to be pre-specified. Probably the biggest change in the landscape since we started enrollment is the approval of checkpoint inhibitors in this space, and we probably have patients that have received checkpoint therapy, and if there's an imbalance between the 2 arms of the study the subgroup analysis should account for that. But, it’s something that’s really impossible to predict how the changing SOC is going to effect the results of the control arms - this is why we have to run double-blind. Probably one predictor would be if we reach the number of interim events necessary to trigger the interim analyses, and the general projections that can give us some a little bit of confidence that these aren't too different than what we have previously seen.
George Zavoico - JonesTrading Institutional Services LLC
GZ: ”Quick question about MSKCC, Memorial Sloan Kettering, are they a site in the SUNRISE trial?”
Joe Shan: They are not a site in the SUNRISE trial, but we are discussing opening some of the new trials there.
GZ: ”Re: AZ's durvalumab, in the NSCLC space, we already have the 2 other PD-1s approved. How are you thinking of positioning the durvalumab-bavi combination in the already approved Opdivo/Keytruda space? How are you going to differentiate it and do you ever anticipate head-to-head comparison study?”
Joe Shan: The reason why we think this is a great opportunity is that the anti-PD-L1 agents, which none of them are approved yet in lung cancer, so far clinically they're behaving very similarly to approved anti-PD-1 agents. So, monotherapy head-to-head, that’s not a trial we're interested in doing. The differentiator for us is, can bavi make durvalumab, a PD-L1, better? If so, we would, I guess, extrapolate that into a benefit for other PD-1 or PD-L1 inhibitors. So, that’s our strategy, by showing, like in the preclinical setting, that bavi can modulate focal immunity and activate T-Cells and drives PD-1 expression, which makes PD-1 access blockhead more effective.
GZ: ”So basically if some positive result durvalumab actually open source for you with the other players in the space?”
Joe Shan: We still have to run the studies...
GZ: ”Right, of course.”
Steve King: The key here is that, from an activity standpoint, all the PD-1/PD-L1 targeting agents are all more or less interchangeable, and I think that there is no clear signal right now that any of them is really outperforming the others. And, I agree that’s not really our job to show which one of those is best, but really to show how we can actually make them all better. That’s how we view the durvalumab study, the ability to show that bavituximab can potentially make targeting PD-1 or PD-L1 a better therapy and that we can get more patients to respond. This is a Ph.2 study; if we can improve the long-term responses to durvalumab, we think that really extrapolates to the other molecules and is still leaves the potential of a Ph.3 with any of the molecules, which sets the stage on the partnering front for lots of opportunities to work with the difference groups.
GZ: ”Great. Congratulations, sounds like next year is going to be really interesting one to watch. Thank you.”
3. Rahul Jasuja - Noble Life Science Partners http://noblelsp.com/research
RJ: ”In planning your combination studies going forward, we are looking at PD-L1 low tumors because they are likely to be non-responsive to anti-PD-1's, like in Keytruda & Opdivo. Is that the only the rational, or is it also likely that PD-L1 low tumors also more responsive to bavituximab?”
Steve King: That’s what we want to show out in some of these studies we’re starting. We’re not planning on selecting for PD-L1 neg. patients in the Phase II study or the initial combination of bavi with chemo & durvalumab, but rather taking all-comers and then doing subset analysis and determining which patient populations we’re having the biggest impact in. Because, based on our translational data that’s been presented this year at ESMO & SITC'15 [11-9-15/SITC: http://tinyurl.com/pbof95w ], we’ve shown that we can take PD-L1 neg. tumors and actually elicit an immune response in those tumors. That’s the reason that we think that we have the potential to turn those into better responders on a PD-1 or PD-L1 therapy. As I mentioned during the prepared remarks it’s basically, “use bavi to get the immune response going and then use durvalumab to keep it going.” That's the reason there is a great scientific rationale right now for why we may have the biggest impact in those patients who don’t do well, because the delta between how they would normally do and how they might do with bavituximab may be the largest. We’re going to have some great insight into that from the studies we’re planning on running and the ability to go in and do subset analysis. Joe, do you want to add any more to that?
Joe Shan: I was going to use the word delta, but you beat me to it. I think in the PD-L1 neg. patient you have more opportunities to demonstrate the delta.
RJ: ”One of the concepts that’s evolving pretty rapidly is that you’ve got the TILs- & TILs+, and TILs+ are responding to PD-1 checkpoint immunotherapy. So is it fair to say, or is it an extrapolation, that PD-L1 positive tumors are more likely the ones that are TILs+? And in your case are you also seeing that TILs- tumors are probably the ones that are going to respond to chemo combination therapy better than the other ones that are the non-responders in combination with PS you can make them responders.”
Steve King: That’s certainly what our evidence has shown so far. The general assumption is that TILs- or TILs/Low tumors the ones that have low levels of the need for PD-L1, right, that’s really meant to stop an ongoing immune response. I think that’s generally true. Now it gets a little bit more complex because you’ve got Tregs and all kinds of T-cells present inside the tumor, so it also depends on the particular makeup. What we know is that when you get bavituximab, we seem to see a nice change in the levels of MDSCs (Myeloid-Derived Suppressor Cells) who are really the cell type that’s responsible for controlling the immune response in the tumor. It's been shown that patients with high levels of MDSCs have very poor prognosis. So as much as probably getting new TILs into the tumors is important, it’s probably more important to change the makeup of those cells into a more productive immune response positive phenotype. That’s exactly what we see with when you get bavituximab treatment; when we take a look a look at our translational data it shows an increase in CD4+ T-Cells and an increase in CD8+ T-Cells along with the changes in the suppressive cells types and the expression of immuno-suppressor cytokines, in which both decrease after treatment. So, it’s a matter of getting everything moving in the right direction. Again this is the role we think PS plays, by blocking it and activating an immune response, we're able to turn that around.
RJ: ”That does make sense. I think you’re looking at patient selection as being helpful in defining the population as well as the data you showedat SITC'15 [11-9-15/Duke's Herbert K. Lyerly http://tinyurl.com/pbof95w ], where you talked about immuno-profiling and looking at response to bavituximab, those are very interesting datasets. The other question I have is, there are a couple of trials running that are ISTs [at UTSW] - one of them is bavi in combination with Yervoy(ipilimumab) in melanoma, and the other one is a rectal cancer IST. Any updates on those?”
Steve King: The Rectal adenocarcinoma, we expect to have some data coming up this year from that study. As in any IST, it’s always a bit difficult, we do whatever we can to encourage them. But we do expect data to be becoming out of that study in 2015, which I think will be a real positive because in that study we did have the opportunity to collect pre- and post-treatment biopsies - #1, so we can see what happens following bavituximab treatment, but also that was a combination with radiation which we expect to be a very strong inducer of tumor antigens, which can then be taking advantage of by bavituximab treatment to make CD8+ T-Cells or killer T-Cells. For the Melanoma study, obviously the since that investigator (UTSW) started this study the SOC has changed pretty substantially. So right now, we're trying to work with that investigator, as well as some others, to probably change the profile of that study or start a new multi-center study in which we can then look at little bit more closely at what is the current SOC and make sure it’s an attractive trial for patients. As the treatment options for patient’s change, you need to be able to change with it and luckily it's a small IST trial and we may have an opportunity here to run a trial that I think would be very attractive for patients and will allow us to answer some key questions, because that was really the point of that study was to answer some of the key questions of combining with Yervoy. In addition, we’re starting the combination of durvalumab [AZN collab.] in multiple solid tumor types after the beginning of the year, so one way or another we’ll have lots of information coming from those studies.
RJ: ”Any updates any more color or comments on the collaboration with Sloan Kettering and Jed Wolchok on combination approaches - any data coming that way in the next few months?”
Steve King: That's an ongoing process. We’re very actively working with them to study a new combinations, looking for potential and different indications as well as those different combinations. We fully expect that it will be a fruitful collaboration; there will be a lots of data coming from that that we’ll see a very scientific meetings coming up. We already see a lot of data coming out of all for other collaborators nad we’ve had examples of presentations in multiple conferences this year. It always takes a while for them to get started, but then once they are going you tend to have a lot of data that continuously comes through them because the all the systems are up and running.
RJ:”Great.Thank you and congratulations on the healthy revenues at Avid.”
MR. KING’S CLOSING COMMENTS:
I’d like to thank all of you for participating in today’s phone call. As always, I want to especially thank our stockholders for their continued support, our mfg. clients for their continued business, and as always our patients and their families that are participating in our bavituximab clinical trials. With that, we will now conclude the call.
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12-10-15 PR: ”Peregrine Pharmaceuticals Reports Financial Results for 2ndQuarter of FY2016 2016 and Recent Developments”
* Peregrine and AstraZeneca Expand Immuno-Oncology Collaboration and Plan Phase II NSCLC Trial
* Phase III SUNRISE Clinical Trial Expected to Complete Enrollment in Coming Weeks While New Clinical Trials Are Being Initiated
* Peregrine Closes $20mm Financing to Support Late-Stage Clinical Trials
* Biomanufacturing Business, Avid Bioservices, Posts Strong Quarter With a 52% Increase in Revenue
* New State-of-the-Art Production Facility Ready for Initial Phase of GMP Manufacturing
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=946616
TUSTIN, Dec. 10, 2015: Peregrine Pharmaceuticals, Inc. (NASDAQ: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 2nd quarter of FY2016 ended October 31, 2015, and provided an update on its advancing clinical pipeline and other corporate developments.
Highlights Since July 31, 2015
"I am pleased to report that we are nearing completion of enrollment for our Phase III SUNRISE trial with over 90% of the intended number of patients enrolled. We have also made substantial progress toward initiating several new trials including a Phase II/III breast cancer study and a Phase II NSCLC trial in combination with AstraZeneca's anti-PD-L1 antibody, durvalumab," said Steven W. King, President and CEO of Peregrine. "Our goal is to transition our leading SUNRISE clinical sites into our new Phase II NSCLC trial which should significantly expedite study start-up activities. We are encouraged by the fact that a number of investigators from hospitals that participated in the SUNRISE trial have already enthusiastically agreed to participate in our upcoming NSCLC trial."
"As treatment paradigms shift to incorporate new drugs, it is clear that both chemotherapy and immuno-oncology agents will continue to be critical to patient care. Taken together, we believe our SUNRISE trial, as well as the newly planned breast and lung cancer trials will allow us to maximize the potential of bavituximab in both settings," said Joseph Shan, VP of Clinical & Regulatory Affairs of Peregrine. "We are committed to continuing to identify new potential indications, patient populations and therapies that can benefit from combination treatment with bavituximab. From what we have seen to date in our preclinical and translational studies, the opportunity appears vast, and we are hard at work converting the most promising prospects into true value."
Clinical Development Highlights
As of today, more than 90% of the planned number of patients have been enrolled in the Phase III SUNRISE trial, representing a sufficient number of patients required to trigger the two pre-planned interim analyses as well as the final analysis for trial unblinding. The company expects to reach the trial's estimated enrollment of 582 patients in the coming weeks.
Peregrine and AstraZeneca expanded their cancer immunotherapy clinical trial collaboration to evaluate bavituximab in combination with AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736). The companies are currently planning a global Phase II study in patients with previously treated squamous or non-squamous NSCLC, as well as a Phase I/Ib trial that will evaluate the safety and efficacy of bavituximab in combination with durvalumab and chemotherapy in multiple solid tumors. The company expects the Phase II study to be initiated in early 2016 with the Phase I/Ib study beginning later in 2016.
Peregrine continues to finalize plans for its Phase II/III trial to evaluate bavituximab with chemotherapy combinations in HER2-negative metastatic breast cancer. This trial is on track to be initiated by the end of calendar year 2015.
Supportive Research Highlights
Positive results were presented at the 2015 annual meeting of the Society for Immunotherapy of Cancer (SITC) [11-9-15: SITC'15 'New Bavi+Checkpoint Inhibitors preclin. data (UTSW/DUKE's Herbert K. Lyerly) http://tinyurl.com/pbof95w ] 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.
New data presented at the International Association for the Study of Lung Cancer's (IASLC's) World Conference on Lung Cancer (WCLC) [9-8-15: Scott Antonia/MoffittCC IASLC’15 Mini-Oral Presentation Slideshow http://tinyurl.com/p9eduac ] from a translational study of bavituximab demonstrated the ability of bavituximab, alone or in combination with docetaxel, to induce signs of immune activation in non-small cell lung cancer (NSCLC) patient-derived tumor samples, particularly when there was negative PD-L1 expression in the tumor sample. These data further support the potential mechanistic synergies for bavituximab with chemotherapy and checkpoint inhibitors targeting the PD-1/PD-L1 pathway.
Summary data presented at the Combination Immunotherapy Strategies session at the 10th Annual Immunotherapy and Vaccine Summit (ImVacS) [8-26-15: ImVacS'15 http://tinyurl.com/qz64pzg ], highlighted key findings from several recent bavituximab-focused studies including: the potential of bavituximab to shift the tumor microenvironment from immuno-suppressive in which tumors evade immune detection to a state of immune activation in which the immune system recognizes and fights the tumor; bavituximab's potential to increase the number of activated CD8+ cells in the tumor, which stimulates PD-1 expression, potentially increasing the number of patients able to respond to PD-1 and PD-L1 targeting immunotherapies; and, results from several clinical and preclinical studies in a range of tumor types showing that bavituximab and bavituximab-like antibodies, in combination with conventional therapy, have consistently demonstrated Kaplan-Meier graphs that follow the classic immunotherapy survival plateau.
Corporate Highlights
Peregrine closed a registered direct offering to a single institutional investor raising $20mm dollars [10-30-15: Kenneth Dart (Eastern Capital) acquires 13.1% stake (30,106,945sh.) in PPHM http://tinyurl.com/24qctos ]. The funds raised from this financing will support the ongoing Phase III SUNRISE trial, and newly planned later-stage company-sponsored trials in breast cancer and NSCLC.
Avid Bioservices Highlights
"Our contract manufacturing business continues to strengthen with a 52% current quarter increase in revenue compared to the prior year period and year-to-date growth of 61%," stated Paul Lytle, CFO of Peregrine. "Our new state-of-the-art manufacturing facility is now ready for the initial phase of GMP manufacturing and demand for Avid's capacity continues to grow with our current backlog now at $49mm. Given the revenue growth and committed backlog, we are increasing our contract manufacturing revenue guidance to a range of $35 to $40mm for the full-year 2016."
During the second quarter of FY 2016, Avid Bioservices achieved record-breaking revenues generating approximately $9.5mm dollars, a 52% increase in revenue compared to the same quarter in the prior year.
Avid's new manufacturing facility is now ready for the initial phase of GMP manufacturing. The state-of-the-art facility will accommodate single use bioreactors (SUBs) at up to 2,000 liter scale. Upcoming production runs will support late stage clinical development as well as process validation activities in anticipation of bavituximab and other client commercial product needs. The facility has the capacity to potentially generate approximately $40mm in new revenue annually.
Contract manufacturing committed backlog reached $49mm from existing customers covering services to be completed in FY 2016 and into FY 2017.
Financial Results
Total revenues for the second quarter of FY 2016 were $9,523,000, compared to $6,300,000 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 second quarter FY 2016 were $9,523,000, compared to $6,263,000 for the same quarter of the prior fiscal year. Peregrine expects third-party contract manufacturing revenue for the entire fiscal year to be between $35mm and $40mm, compared to previous guidance of $30mm to $35mm during last quarter's earnings call. In addition to providing biomanufacturing services to its third-party clients, Avid will continue to support the clinical development and potential commercialization of bavituximab.
Total costs and expenses in the second quarter of FY 2016 were $23,347,000, compared to $18,437,000 in the second quarter of FY 2015. This increase was primarily attributable to current quarter increases in research and development expenses associated with the SUNRISE Phase III trial, newly planned later-stage company-sponsored trials in breast cancer and NSCLC, and an increase in the cost of contract manufacturing associated with higher reported revenue. For the second quarter of FY 2016, research and development expenses were $14,190,000, compared to $10,003,000 for the second quarter of FY 2015. For the second quarter of FY 2016, cost of contract manufacturing was $4,741,000, compared to $4,139,000 for the second quarter of FY 2015.
Peregrine's consolidated net loss attributable to common stockholders was $14,578,000, or $0.07 per share, for the second quarter of FY 2016, compared to a net loss attributable to common stockholders of $13,131,000, or $0.07 per share, for the same prior year quarter.
Peregrine reported $72,005,000 in cash and cash equivalents as of October 31, 2015 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/zdbo9rv ]
Conference Call
Peregrine will host a conference call and webcast this afternoon, December 10, 2015, at 4:30 PM ET (1:30 PM 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 with a pipeline of novel drug candidates in clinical trials focused on the treatment of cancer. The company's lead immunotherapy candidate, bavituximab, is in Phase III development for the treatment of previously treated non-small cell lung cancer (the "SUNRISE trial") along with several investigator-sponsored trials evaluating other treatment combinations and additional oncology indications. 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 .
Safe Harbor *snip*
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
(UNAUDITED)
THREE MONTHS ENDED
OCTOBER 31,
SIX MONTHS ENDED
OCTOBER 31,
2015 2014 2015 2014
REVENUES:
Contract manufacturing revenue $ 9,523,000 $ 6,263,000 $ 18,902,000 $ 11,759,000
License revenue - 37,000 292,000 37,000
Total revenues 9,523,000 6,300,000 19,194,000 11,796,000
COSTS AND EXPENSES:
Cost of contract manufacturing 4,741,000 4,139,000 9,349,000 7,722,000
Research and development 14,190,000 10,003,000 28,108,000 20,204,000
Selling, general and administrative 4,416,000 4,295,000 9,315,000 9,178,000
Total costs and expenses 23,347,000 18,437,000 46,772,000 37,104,000
LOSS FROM OPERATIONS (13,824,000 ) (12,137,000 ) (27,578,000 ) (25,308,000 )
Interest and other income 626,000 37,000 657,000 79,000
NET LOSS $ (13,198,000 ) $ (12,100,000 ) $ (26,921,000 ) $ (25,229,000 )
COMPREHENSIVE LOSS $ (13,198,000 ) $ (12,100,000 ) $ (26,921,000 ) $ (25,229,000 )
Series E preferred stock accumulated dividends (1,380,000 ) (1,031,000 ) (2,413,000 ) (1,802,000 )
Net loss attributable to common stockholders $ (14,578,000 ) $ (13,131,000 ) $ (29,334,000 ) $ (27,031,000 )
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:
Basic and Diluted 203,942,411 179,962,275 200,629,892 179,540,265
BASIC AND DILUTED LOSS PER COMMON SHARE $ (0.07 ) $ (0. 07 ) $ (0.15 ) $ (0.15 )
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
OCTOBER 31,
2015 APRIL 30,
2015
Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 72,005,000 $ 68,001,000
Trade and other receivables, net 2,904,000 3,813,000
Inventories 12,554,000 7,354,000
Prepaid expenses and other current assets, net 1,995,000 1,355,000
Total current assets 89,458,000 80,523,000
Property and equipment, net 21,764,000 15,124,000
Other assets 1,435,000 1,817,000
TOTAL ASSETS $ 112,657,000 $ 97,464,000
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 6,901,000 $ 10,385,000
Accrued clinical trial and related fees 6,138,000 3,910,000
Accrued payroll and related costs 4,130,000 4,606,000
Deferred revenue 9,688,000 6,630,000
Customer deposits 14,935,000 11,363,000
Other current liabilities 667,000 437,000
Total current liabilities 42,459,000 37,331,000
Deferred rent, less current portion 972,000 1,098,000
Commitments and contingencies
STOCKHOLDERS' EQUITY:
Preferred stock - $0.001 par value; authorized 5,000,000 shares; issued and outstanding - 1,577,440 and 1,574,764, respectively 2,000 2,000
Common stock - $0.001 par value; authorized 500,000,000 shares; outstanding – 225,824,551 and 193,346,627, respectively 226,000 193,000
Additional paid-in capital 549,543,000 512,464,000
Accumulated deficit (480,545,000 ) (453,624,000 )
Total stockholders' equity 69,226,000 59,035,000
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 112,657,000 $ 97,464,000
• 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 Dec. 9, 2015, there were 229,701,808 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 10-31-15 iss. 12-10-15 http://tinyurl.com/zdbo9rv PR: http://tinyurl.com/jkp885g (Cash 10-31-15=$72.0mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
.
= = = = = = = = = = = = = = = = = = = = = = = = = = = =
Updated PPHM REVS-BY-QTR TABLE, now thru FY16'Q2(qe 10-31-15), per the 10-31-15 10-Q ( http://tinyurl.com/ocrtkuj ) issued 12-10-15.
• Total Revs since May’06: ($148.1mm/Avid + $24.1mm/Govt + $2.4mm/Lic.) = $174.7mm
• Deferred-Revs at 10-31-15, going fwd into FY’16/Q3 (q/e 1-31-16), total $9.7mm, UP from the $8.3mm of Deferred-Revs at 7-31-15 that drove into FY’16/Q2.
• Cust.Deposits at 10-31-15 total $14.9mm, UP from $9.6mm at 7-31-15.
• Avid’s Gross-Profit over last 3 qtrs: $14.1mm on revs of $28.2mm (GP%=50%)
• Recall, Avid Rev$ 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)
= = = = = = = = = = = =
“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
= = = = = = = = = = 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."
= = = = = = = = = = = = = = = = = =
11-9-15 SITC'15: New Bavi+Checkpoint Inhibitors preclin. data (UTSW/DUKE's Herbert K. Lyerly) http://tinyurl.com/pbof95w
...Also, collab. with Dr. Bernard Fox (Immunotherapist/Earle A. Chiles Res.Inst.) on new Immuno-Profiling Clinical Test (Opal 6-plex quantitative IF Assay), PPHM roundtable with Raymond Birge (Rutgers), Douglas Graham (Emory), Dmitry Gabrilovich (Wistar), Rolf Brekken (UTSW), Maria Karasarides (AstraZeneca) - ”Combining Bavi w/anti-PD-1 significantly enhanced O/S… significant incr. CD45+, CD8+ and CD3+ T-cells… led a prolonged anti-tumor immune response which protected the animals against a re-challenge w/same tumor.”
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
9-9-15 Qtly. Conf. Call (King/Shan/Worsley/Lytle) Transcript http://tinyurl.com/ph22vdn
...CEO S.King: “The Memorial Sloan Kettering & AstraZeneca collaborations are an important part of our announced plans to expand our bavituximab clinical pgm.”
8-26-15: Jeff Hutchins(VP/PreClin-Res) ImVacS’15 Talk – 29pg. Slideshow http://tinyurl.com/qz64pzg
…“Expansion & Activation of T Cells via the Targeting of the Immunosuppressive Ligand PS: Combination Strategy with Conventional, Targeted, and Checkpoint Inhibitor Therapy”
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
7-14-15 Qtly. Conf. Call (King/Shan/Hutchins/Lytle) Transcript http://tinyurl.com/nw2v5u6
...CEO S.King: “We recently entered into collaboration with investigators at Memorial Sloan Kettering Cancer Ctr to continue expanding on this important work, as well as to explore other potential applications of bavituximab and other agents that target PS-signaling pathway.”
BAVI MOA 8-26-15: Jeff Hutchins(VP/PreClin-Res) ImVacS’15 Talk – 29pg. Slideshow http://tinyurl.com/qz64pzg
…“Expansion & Activation of T Cells via the Targeting of the Immunosuppressive Ligand PS: Combination Strategy with Conventional, Targeted, and Checkpoint Inhibitor Therapy”
5-31-15: ASCO’15 Roundtable (webcast), “Raising the Immuno-Oncology Bar” - 7 panel members, incl. 3 Sloan Kettering researchers http://tinyurl.com/qxu4w2x
BAVI MOA 3-25-15: PPHM/VP Dr. Jeff Hutchins’ presentation at "Immune Checkpoint Inhibitors Conf.", Boston - PDF(34 Slides): http://tinyurl.com/ooxkhq7
BAVI MOA 2-9-15: PPHM/VP Dr. Bruce Freimark’s presentation at KEYSTONE "Tumor Immunology Meeting", Banff/CN – PR & Slides: http://tinyurl.com/q6cx4w6
=> Total Revs May06-Oct15: $148.1mm/Avid + $24.1mm/Govt + $2.4mm/Lic. = $174.7mm. Cash at 10-31-15: $72.0mm
As of Dec. 9, 2015, there were 229,701,808 shares outstanding.
This large post has 3 sections:
I. 12-10-15 Q2/FY16 Qtly. Earnings Conf. Call TRANSCRIPT (q/e 10-31-15)
II. 12-10-15 PPHM Press Release: Q2/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/zq52d5w ], with numerous corrections made. )))
Link to webcast replay:
http://ir.peregrineinc.com/events.cfm => http://edge.media-server.com/m/p/jigxfb5c
FULL TRANSCRIPT…
12-10-2015 FY’16/Q2 Earnings Conf. Call (q/e 10-31-15)
WELCOME & FWD-LOOKING STATEMENTS: Tim Brons, Vida Strategic Partners (IR) http://www.peregrineinc.com
Speakers: Steve King, Joe Shan, Stephen Worsley, Rob Garnick, Paul Lytle; Q&A session.
CEO STEVE KING – OPENING COMMENTS:
Thanks as always to all of you who have dialed in, and to all of you who are participating via webcast today. I’ll start by saying that we are making great progress in our broad overall development strategy for bavituximab. The strategy is to establish the potential of bavituximab in combination with current & evolving standard of care drugs, with both chemotherapy and immuno-oncology combinations in multiple cancer indications. Our goal is to drive to meaningful clinical data points in each of these areas by early 2017. In accordance, today’s development discussions will focus on these efforts, including upcoming completion enrollment in the SUNRISE trial which is evaluating a chemotherapy combination, and, as SUNRISE wraps up, our plans for a smooth transition of the key SUNRISE clinical sites directly to the next Phase II lung cancer trial evaluating an IO combination. In addition, we are expanding our potential cancer indications through initiation of a Phase II/III metastatic breast cancer study. All of this while continuing to work through several other clinical trial concepts actively under development or initiation in the new year.
On the development front, I’m pleased to report today that we are nearing completion of enrollment in the cornerstone of our bavituximab development strategy, our Phase III SUNRISE trial. In fact, with over 90% of the expected enrollment complete, we currently have sufficient patient enrollment based on the assumptions of the study to allow the trial’s planned interim evaluations and final readout based on the primary endpoint of overall survival. Having said that, we do expect to complete enrollment of at least the pre-specified 582 patients over the coming weeks. At this point, the next big milestones really are the interim data analysis from the study, expected to take place during early & mid 2016, with trial unblinding expected toward the end of 2016. Joe will add little more color to the up coming milestones for the SUNRISE trial during his prepared remarks.
For me, what has now become the most important thing at this point in our broader strategy is to engage our best enrolling sites from the SUNRISE trial toward a smooth transition to the new Phase II study that will evaluate bavi in combination with AstraZeneca’s anti-PD-L1 antibody durvalumab. We have a golden opportunity here to maintain continuity for our lung cancer program by continuing almost seamlessly working with our high enrolling sites and key investigators in essentially the same, even in extended, patient population with the inclusion of squamous non-small cell lung cancer patients. I have personally had the opportunity to meet with key investigators all over the globe and there is a lot of enthusiasm for continuing to work with Peregrine and bavituximab in the new study. Based on feedback so far, we expect that the new study could enroll even more quickly than the SUNRISE trial and the best way to ensure that is to get off to a quick start, again keeping us on track for data from the new study by early 2017. This would give us two nice sets of data in NSCLC to work with.
Equally exciting is the Phase II/III metastatic HER2- breast cancer study that we are looking forward to starting by year-end. I say exciting because the new trial design has a solid clinical data basis, and our previously completed Phase I & II trials in a patient population in these new treatment options. While we don’t have the same benefit as we do for the lung cancer program of rolling right from one study into another, the team has been working diligently to get the study started by the year-end, giving us additional enrollment months, which again can put us on track for some meaningful clinical data from the study by early 2017.
The company is also working diligently on a number of other studies, including our other collaboration with AstraZeneca, evaluating a combination of bavi with chemotherapy and adding in again their durvalumab antibody in multiple solid tumor indications. So, conceptually, “get an immune response going with chemotherapy & Bavi, and then keep it going with durvalumab”.
In addition, we are working toward initiating an earlier stage breast cancer study, as well as a number of other concepts that are in development. So, stay tuned for future clinical developments. Taken together, these clinical efforts, along with the plethora of preclinical & translation collaborations evaluating new combinations, new potential indications, and further validating our immune mechanism of action has a potential to add substantial value over the coming year. We expect a steady flow of scientific & clinical presentations over the coming year as we continue to learn to more about the potential bavituximab.
Oh, and by the way, today we also announced another record revenue quarter from our biomanufacturing business, with our new Myford manufacturing facility just ready for GMP production, which can help spur even more future growth for the business, not the least of which is getting ready for bavi commercial production. Rob & Paul will add more detail and discuss the continued growth for our mfg. business shortly. To say that these are busy times at Peregrine is an understatement.
JOE SHAN (VP/Clin.&Reg. Affairs) – CLINICAL TRIALS:
I’d like to start by quickly addressing our Phase III SUNRISE trial, which is evaluating the use of bavituximab & docetaxel in patients with previously treated locally advanced or metastatic non-squamous NSCLC. As Steve stated, we have already enrolled the number of patients required to achieve the trial’s main objectives, and expect to complete enrollment of the target sample size of 582 in the coming weeks. The next milestones are the interim analyses that will be conducted when 33% & 50% of the targeted number of deaths are reached. While these are event driven, it is our expectation that the 1st interim analysis will read out in early 2016 and the 2nd interim analysis around mid-2016. The final analysis, which will trigger study unblinding, is currently projected to occur at the end of 2016.
With the SUNRISE enrollment nearing completion, the Peregrine clinical team is shifting focus to a number of new clinical projects, including those just referenced by Steve. In each case, our goal is to generate clinical evidence of bavituximab’s ability to improve patient outcomes when combined with chemotherapy and immuno-oncology agents. With this goal in mind, we are very pleased to be collaborating with AstraZeneca. Through this partnership, we will be conducting 2 clinical trials, both of which will be initiated in 2016. One trial, which we expect to initiate early 2016, is a global randomized Phase II study in approx. 200 patients with previously treated NSCLC. This trial will evaluate the combination of bavituximab and AZ’s anti-PD-L1 immune checkpoint inhibitor durvalumab, or MEDI4736. As part of this combination trial, patients will also be evaluated retrospectively for the correlation between their PD-L1 levels & clinical outcomes. As the remaining patients are enrolled into SUNRISE, we have already begin laying the groundwork to quickly initiate this new Phase II combination study at a number of our most active sites participating in SUNRISE. These investigators are very familiar with bavituximab and have access to the appropriate patient populations, and we believe this experience will greatly benefit our new study.
The other trial with AstraZeneca will be a Phase I/Ib trial evaluating bavituximab in combination with chemotherapy & durvalumab in multiple solid tumors. The Phase I part of the trial will confirm the tolerability of the 2 IO agents and establish a recommended dose regimen for the Phase 1b part of the trial, which will assess safety & activity of the triple combination, which includes standard chemotherapy.
We’re particularly excited about these trials because we believe that bavituximab & durvalumab have different and potentially complementary mechanisms. Bavituximab, by targeting exposed PS, a highly immuno-suppressive molecule exposed on the surface of cells in the tumor microenvironment, has been shown to trigger macrophage re-polarization and tumor specific T-Cell activation. Durvalumab is a monoclonal antibody directed against programmed cell death ligand1, or PD-L1, and signals from PD-L1 help tumors avoid detection by the immune system. It’s become apparent that check inhibitors like durvalumab are most effective when there is a preexisting T-Cell response in tumors, as it provides those check inhibitors with the immune active environment they need to work best. Importantly, we have demonstrated in preclinical models the ability of bavituximab to activate CD8+ T-Cells and the anti-tumor activity PD-L1 checkpoint blockade is greatly enhanced when combined with bavituximab. Another important observation we recently made is that our PS signaling pathway inhibitors demonstrate multiple signs of immune activation in the low or negative PD-L1 tumors. We believe that this holds great potential to increase the number of patients able to respond to checkpoint therapy as well as traditional chemotherapy. Based on these observations, we believe that by combining these 2 approaches, the potential exists for a more complete & durable anti-tumor immune response. We look forward to getting both trials in our AstraZeneca collaboration underway.
Now, beyond lung cancer, we plan to initiate addl. clinical trials in breast cancer based on our clinical experience to-date. Data from a Phase I IST of bavituximab+paclitaxel published in Cancer Medicine earlier this year [3-31-15/A.Stopeck, N=13: PFS=7.3mos, ORR=85%, 2 CR's http://tinyurl.com/nm5oog4 ] demonstrated an impressive 85% response rate of patients with HER2- metastatic breast cancer. Data from this IST, together with 2 prior Peregrine-sponsored trials of bavituximab with taxane-based chemotherapy, which yielded between 61-74% response rates and a MOS of over 20mos. in patients with advanced or metastatic breast cancer, provides strong rationale to advance this indication. Importantly, taxanes continue to be a key std. treatment option for different stages of breast cancer. Accordingly, we plan to initiate a Phase II/III trial in patients with HER2- metastatic breast cancer, with all patients receiving physicians’ choice of paclitaxel or docetaxel, either alone or in combination with bavituximab. The Phase II part of the trial will enroll approx. 150 patients with a primary end point from overall response rate. The first sites in this Phase II/III breast cancer trial are scheduled to be initiated before the end of the year. Furthermore, we're planning a trial evaluating neoadjuvant paclitaxel with or without bavituximab, in the hopes of further elucidating bavituximab’s immune modulating mechanism and look for clinical signals in early stage breast cancer. That concludes my comments today I’d like to turn the call over to Steve Worsley to give an overview of business development activity.
STEPHEN WORSLEY (VP/Business Dev.):
We were very pleased to announce our collaboration with AstraZeneca in August [8-24-15: http://tinyurl.com/owlxpsf ] and were even more delighted to announce the expansion of that agreement in October [10-15-15: http://tinyurl.com/q79bkam ]. We believe that AstraZeneca’s enthusiasm for this program is based on the promise & potential of bavituximab. Copious amounts of positive data have consistently demonstrated bavituximab’s therapeutic value & ability to provide solutions to the limitations of currently available treatments. Today, checkpoint inhibitors are primarily effective in patients with high PD-L1 expression, a minority of all patients being treated. However, translational findings have demonstrated that bavituximab is effective in patients with the lowest PD-L1, PD-1 expressions, highlighting the potential bavituximab to convert patients with the low expression levels who do not respond to anti-PD-1 treatments into responders.
In addition to AstraZeneca, such data have also been the impetus for our ongoing collaboration with Memorial Sloan Kettering Cancer [5-21-15: http://tinyurl.com/qxu4w2x ], which is evaluating combinations of bavituximab with other checkpoint inhibitors & immune stimulatory agents for the purpose of developing new & increasingly effective anti-cancer treatments. It has also been the driver for our ongoing work with the Univ. of Texas SW, as well as a number of other ISTs.
Peregrine’s goal in partnering with these immuno-oncology leaders is to define the broader scope of utility for bavituximab. Through these collaborations, we are actively identifying a range of indications & treatments that will benefit from combination therapy with bavituximab. This will undoubtedly yields important findings in the near-term that will continue to build shareholder value. We continue our dialog with a number of other world leading pharmaceutical organizations and believe that bavituximab will continue to generate partnering interest. I will now turn the call over to Rob Garnick, Peregrine’s Head of Regulatory Affairs, who’ll discuss our drug mfg. & regulatory activities.
Rob Garnick (Head of Regulatory Affairs):
As we reported in our press release today, our new facility has just been commissioned for the initial phase of GMP manufacturing. I’d like to reiterate that this facility, currently named the Myford facility, is state-of-the-art and its construction was completed for a fraction of the cost of building of comparable facilities. This in and of itself is a major accomplishment and I am very proud of our team for their success in this achievement. Going forward, we expect this facility will be a highly valuable asset for Peregrine & Avid. Initial engineering runs, which will be initiated tomorrow, will be followed by GMP runs prior to process validation for products entering into the facility. GMP material produced in the new facility can be used either in clinical trials or for commercial sale once Peregrine or Avid’s business partners make the appropriate regulatory filings in the territories where they intend to use the product. This generally requires several runs and demonstrating that the product produced in the Myford facility is comparable to product produced in our Franklin facility or in other production facilities. With the Myford site now in the initial phase of GMP manufacturing, we have seen a significant increase in demand for production capacity. Although, we have just opened the doors at Myford, we are already contemplating our options to increase further mfg. capacity. Although no decisions have been made, we are pleased to have what appears to be a growing opportunity in this important area of our business.
On the regulatory side, we are busy to taking the steps necessary to initiate up the new clinical trials that Joe described. To this end, we successfully filed the new IND supporting expanding the bavituximab breast cancer program and subsequently received FDA clearance to commence the study. We have also taken important steps to de-risk our bavituximab/durvalumab combination trials by requesting and receiving critical guidelines from the FDA. It’s been a busy time for the regulatory affairs team, but our recent efforts have put us on track to grow our mfg. business and initiate our newest clinical programs. This concludes my comments and I will now turn the call over to CFO Paul Lytle, who will discuss the company’s financial performance and our Avid Bioservices business.
CFO Paul Lytle:
I’ll start with an overview of our contract mfg. business. The Avid Bioservices business continues to strengthen. During Q2, our wholly-owned subsidiary achieved record quarterly revenue of $9.5mm, a 52% increase over the same prior year qtr. Year-to-date, we recorded mfg. revenue of $18.9mm or a 61% 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. This has raised our current revenue backlog to approx. $49mm. Based on this increase in demand, we are raising our revenue guidance to $35-40mm for the full FY2016 compared to previous guidance of $30-35mm.
We also believe that business has more opportunity to grow, as our 2nd mfg. Facility [Myford Facility] has the capacity to generate approx. $40mm in new revenue. As Rob mentioned, the new facility is ready for the initial phase of GMP manufacturing to support both to manufacturing of bavituximab in addition to growing our revenue from 3rd-party customers. As I wrap up this discussion on Avid, I can’t emphasize enough the strategic importance of this business. Avid continues to generate non-dilutive income that in turn continues to offset the amount of capital we need to raise by other means, plus it’s important to note that preparing bavituximab for commercial production is a significant financial endeavor and this strategic asset saves us millions of dollars each year in mfg. costs.
Turning now to expenses, R&D expenses for Q2 increased, primarily due to increase expenses associated with our Phase III SUNRISE trial and our newly planned later stage company-sponsored trials in breast cancer & lung cancer. While G&A expenses remained relatively flat qtr-over-qtr. Lastly, during the quarter Peregrine closed a registered direct offering with a single institutional investor raising $20mm [10-30-15: Kenneth Dart (Eastern Capital) acquires 13.1% stake (30,106,945sh.) in PPHM http://tinyurl.com/24qctos ]. These funds will help support our ongoing Phase III SUNRISE trial as well as our newly planned later staged company-sponsored trials. In more detailed analysis of our statement of operations is included in our Form 10-Q that was filed today. [10Q: http://tinyurl.com/zdbo9rv ] This concludes my financial overview, I now turn the call back over to Steve to discuss some important upcoming milestones.
CEO STEVE KING – MILESTONES:
As you’ve just heard from the team, although our SUNRISE enrollment milestone has been reached, we have no intention of selling down, quite the opposite. We are aggressively moving to initiate the clinical trials that will allow us to build the most robust oncology business possible. By mid-2016, we will initiate 2 breast cancer studies, a Phase II/III trial in metastatic HER2- breast cancer and the Phase I trial in early-stage breast cancer, a new Phase II trial in lung cancer, and a Phase I/Ib trial for multiple solid tumors. These studies will set the stage for expected clinical data readouts from at least 3 trials by early 2017, our SUNRISE Phase III trial, the new Phase II NSCLC trial, as well as the Phase II breast cancer study. In addition, we have other potential data coming from ongoing ISTs, as well as the other studies that we will be initiating. 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 in the true value.
Q&A: [23:30 mark]
1. Thomas Yip (FBR & Co.): http://www.fbr.com
TY: ”….congrats on a good qtr, especially for Avid. Re: the timing of your Phase II trials in lung cancer & breast cancer, are there other advantages to follow SUNRISE so tightly than to speed up enrollment? Because, like you said, we are expecting SUNRISE unblinding in 2nd-half 2016, and then in early 2017 we’ll have 2 Ph2 readouts in lung cancer & breast cancer.”
Steve King: The goal of the new studies is to continue to build the value proposition for the overall portfolio. I think the key to success eventually commercially for bavituximab is to be able to be used in multiple lines of therapy. Clearly the SUNRISE trial represents the combination with docetaxel, a chemotherapy regiment which is going to continue to be used, and the new Phase II study will then expand that into a combination in the IO space with the combination with the PD-L1 inhibitor. Clearly, those types of drugs are going to be used as the lung cancer space continues to evolve over the coming years. And so, the more we can be a part of both those better off we are, and again it’s really a golden opportunity to enroll right from the SUNRISE trial, which is in a very similar patient population to the new trial. The new trial has some advantages in that it will actually include both squamous & non-squamous, so it increases the number of eligible patients. So, to keep those investigators engaged suddenly moving right from one SUNRISE study into another SUNRISE study is a huge advantage in building that relationship with these key investigators and KOLs in the area. The breast cancer study, this is an area we wanted to move forward in previously. We’ve had some great Phase II data, as Joe mentioned, along with the data in HER2- breast cancer patients, in which we saw a nice 85% tumor response rate. That represents as big or a bigger market potential as NSCLC. So, taken together, that really is going to add tremendous value to the program, give us multiple data readouts, and from a partnering perspective adds a lot of potential value to the program. And Steve maybe you want to expand on that a little bit from partnering perspective?
Stephen Worsley: I think the exposure that we’re seeing with these 2 collaborations [AZN & MSKCC] have significantly increased who we're talking to, but also the ability for bavituximab to act in a variety of different indications. This is obviously leading to further discussions with some of the leading oncology players worldwide.
TY: ”Will the Ph1 breast cancer trial be an IST or sponsored by Peregrine?”
Steve King: I think the Ph1 study will end up being a company-sponsored study. It will obviously be a much smaller study than the 2 Ph2's we’re talking about. But it will allow us to run at multiple institutions. There's actually a lot of interest from number of different institutions, that allows us to run a study that we think can add a lot of value, but also that we can move forward on a nice timeline that sets the stage for, within the breast cancer space, a very nice addition to the Ph2 study that we’ll be running in another big patient population represented in that trial.
TY: ”Re: your collaboration with AstraZeneca, it seems that the Ph2 cancer trial has now been accelerated ahead of the solid tumor trial. So can you remind us what the advantages of combining bavituximab w/durvalumab over your previous planned Ph2 trial combination with Opdivo?”
Steve King: The advantages are on several fronts. #1 is it really gives us the flexibility to run the study in the way we want to run the study & where we want to run it. Because otherwise, we’d have to source Nivo [Opdivo=nivolumab] or one of the other PD-1 inhibitors on a regional basis, in which the drug isn’t approved in lot of different regions where you may want to run the study. So just operationally, it gives us the freedom to more efficiently run a study and get it up & running much quicker than we otherwise would have able to. #2, it really gives us a great opportunity to potentially reduce the cost of what study otherwise would have been, because if we would have to go out and acquire the drug for a clinical study, it could as much as double the cost of the trial. So, it just all around allows us to run a much more efficient trial with the drug that’s in our discussions with the KOLs in the field, people with direct experience, they feel that the PD-L1 antibodies work at least as well as the anti-PD-1 antibodies. Our goal is to answer a key question, which is, “can bavituximab add to the activity of a PD-1/PD-L1 inhibitor?”, and this allows us doing on a timeframe. So, there are just a lot of huge advantages. I’ll end that with the fact that also we’re working with a what we think is a great partner [AstraZeneca]. They’ve been very interactive so far. They also have a lot of knowledge of PD-L1/PD-L1 status in the patients, which is one of the things we'll want to be looking at as part of both the Ph2 as well as in the other studies we run in NSCLC, as our ability to have a positive impact on potentially those PD-L1 negative tumors, which don’t typically response well the PD-1 therapy. That’s sort of one of those things that’s hard to put a numeric value to, but is a true advantage of working with a great partner.
TY: “Thanks - look forward to see you guys at JP Morgan.”
2. George Zavoico – Jones Trading http://jonestrading.com
GZ: ”Congrats on a good qtr, particularly with the Avid revenues… You mentioned the possibility of expanding Avid’s mfg. capacity further. #1, will that be without including fill & finish capability, because I think there is a probably pretty good business there as well. And #2, if you do expand, do you have space where you are now you have to expand to some other property?”
Steve King: The expansion really is driven by our existing & new clients that have come in, and so obviously primarily that’s driven in the bulk drug specimens area not necessarily the fill/finish area. So that'll probably be the primary focus; we have considered and eventually would like to move into the fill/finished business, it's just we’ve been so busy expanding our drug specimens business, we really haven’t had the option to do that. For the question of space, there’s space in the current buildings that we’re in, but we’re also looking at other opportunities nearby that fit the same model as we did for the Myford facility and allows us to most efficiently grow the business. At the end of the day it will be a business decision and we’ll take on space as needed to expand the business. Again, it’s all really right now supported by the client base, which has had an extremely positive response to the Myford facility and that’s really driving we think even beyond what we expected going into it.
GZ: ”Would you finance that further expansion as sort of debt against the revenue coming in or are you just keeping all your options open for that?”
Steve King: We’re keeping our options wide open. At this point, we’ll do what’s best for the business itself. It’s a nice growing backlog of future revenue, it’s really a change in the way the Avid business can be viewed, as more a long-term go-forward business. So, we just need to make the right business decision based on the cost of capital, whatever avenue that takes, and then we’ll make the right decision.
GZ: ”Re: SUNRISE, there have been a couple of interesting & unfortunate events with some other companies where OS in the placebo arm of a trial has been much longer than expected. What are you seeing in that regard, because SUNRISE has been going on now for about 2 years now. What kind of advances have you seen in the SOC that might either make us more confident, or maybe a little bit more worried, about the possibility of having a surprise like that?”
Steve King: I can start off and maybe Joe can add in, but when we designed the SUNRISE study we did take into account the variability that had been seen in the docetaxel studies that had been reported up to that point. I don’t think we’ve seen any really significant variations from that as over time as more readouts have come. So, that’s one thing that we did take into account, that we were toward the upper end of what have been previously reported for docetaxel. Secondly, when we powered the study, in the Ph2 study we saw about a 4mos. difference in median OS, and the SUNRISE study was designed to really show a statistical difference even at 2mos; we built in some powering assumptions we think will give us some opportunity there should be arms behave in a way that was little bit unexpected. So, we’ve tried to hedge against that going into the stage design and we think we’re in good shape and now it’s just a matter of getting the readouts - we’re little under 2yrs right now from when we started to study, so at this point there’s really nothing more we can learn from the ongoing operations of the SUNRISE trial itself.
Joe Shan: George, obviously it's a very dynamic field right now. As Steve mentioned, we tried to make the SUNRISE design in such a way that it's as homogenous as practical. We obviously have some stratification criteria built in and some preplanned, subgroup analyses that are going to be pre-specified. Probably the biggest change in the landscape since we started enrollment is the approval of checkpoint inhibitors in this space, and we probably have patients that have received checkpoint therapy, and if there's an imbalance between the 2 arms of the study the subgroup analysis should account for that. But, it’s something that’s really impossible to predict how the changing SOC is going to effect the results of the control arms - this is why we have to run double-blind. Probably one predictor would be if we reach the number of interim events necessary to trigger the interim analyses, and the general projections that can give us some a little bit of confidence that these aren't too different than what we have previously seen.
George Zavoico - JonesTrading Institutional Services LLC
GZ: ”Quick question about MSKCC, Memorial Sloan Kettering, are they a site in the SUNRISE trial?”
Joe Shan: They are not a site in the SUNRISE trial, but we are discussing opening some of the new trials there.
GZ: ”Re: AZ's durvalumab, in the NSCLC space, we already have the 2 other PD-1s approved. How are you thinking of positioning the durvalumab-bavi combination in the already approved Opdivo/Keytruda space? How are you going to differentiate it and do you ever anticipate head-to-head comparison study?”
Joe Shan: The reason why we think this is a great opportunity is that the anti-PD-L1 agents, which none of them are approved yet in lung cancer, so far clinically they're behaving very similarly to approved anti-PD-1 agents. So, monotherapy head-to-head, that’s not a trial we're interested in doing. The differentiator for us is, can bavi make durvalumab, a PD-L1, better? If so, we would, I guess, extrapolate that into a benefit for other PD-1 or PD-L1 inhibitors. So, that’s our strategy, by showing, like in the preclinical setting, that bavi can modulate focal immunity and activate T-Cells and drives PD-1 expression, which makes PD-1 access blockhead more effective.
GZ: ”So basically if some positive result durvalumab actually open source for you with the other players in the space?”
Joe Shan: We still have to run the studies...
GZ: ”Right, of course.”
Steve King: The key here is that, from an activity standpoint, all the PD-1/PD-L1 targeting agents are all more or less interchangeable, and I think that there is no clear signal right now that any of them is really outperforming the others. And, I agree that’s not really our job to show which one of those is best, but really to show how we can actually make them all better. That’s how we view the durvalumab study, the ability to show that bavituximab can potentially make targeting PD-1 or PD-L1 a better therapy and that we can get more patients to respond. This is a Ph.2 study; if we can improve the long-term responses to durvalumab, we think that really extrapolates to the other molecules and is still leaves the potential of a Ph.3 with any of the molecules, which sets the stage on the partnering front for lots of opportunities to work with the difference groups.
GZ: ”Great. Congratulations, sounds like next year is going to be really interesting one to watch. Thank you.”
3. Rahul Jasuja - Noble Life Science Partners http://noblelsp.com/research
RJ: ”In planning your combination studies going forward, we are looking at PD-L1 low tumors because they are likely to be non-responsive to anti-PD-1's, like in Keytruda & Opdivo. Is that the only the rational, or is it also likely that PD-L1 low tumors also more responsive to bavituximab?”
Steve King: That’s what we want to show out in some of these studies we’re starting. We’re not planning on selecting for PD-L1 neg. patients in the Phase II study or the initial combination of bavi with chemo & durvalumab, but rather taking all-comers and then doing subset analysis and determining which patient populations we’re having the biggest impact in. Because, based on our translational data that’s been presented this year at ESMO & SITC'15 [11-9-15/SITC: http://tinyurl.com/pbof95w ], we’ve shown that we can take PD-L1 neg. tumors and actually elicit an immune response in those tumors. That’s the reason that we think that we have the potential to turn those into better responders on a PD-1 or PD-L1 therapy. As I mentioned during the prepared remarks it’s basically, “use bavi to get the immune response going and then use durvalumab to keep it going.” That's the reason there is a great scientific rationale right now for why we may have the biggest impact in those patients who don’t do well, because the delta between how they would normally do and how they might do with bavituximab may be the largest. We’re going to have some great insight into that from the studies we’re planning on running and the ability to go in and do subset analysis. Joe, do you want to add any more to that?
Joe Shan: I was going to use the word delta, but you beat me to it. I think in the PD-L1 neg. patient you have more opportunities to demonstrate the delta.
RJ: ”One of the concepts that’s evolving pretty rapidly is that you’ve got the TILs- & TILs+, and TILs+ are responding to PD-1 checkpoint immunotherapy. So is it fair to say, or is it an extrapolation, that PD-L1 positive tumors are more likely the ones that are TILs+? And in your case are you also seeing that TILs- tumors are probably the ones that are going to respond to chemo combination therapy better than the other ones that are the non-responders in combination with PS you can make them responders.”
Steve King: That’s certainly what our evidence has shown so far. The general assumption is that TILs- or TILs/Low tumors the ones that have low levels of the need for PD-L1, right, that’s really meant to stop an ongoing immune response. I think that’s generally true. Now it gets a little bit more complex because you’ve got Tregs and all kinds of T-cells present inside the tumor, so it also depends on the particular makeup. What we know is that when you get bavituximab, we seem to see a nice change in the levels of MDSCs (Myeloid-Derived Suppressor Cells) who are really the cell type that’s responsible for controlling the immune response in the tumor. It's been shown that patients with high levels of MDSCs have very poor prognosis. So as much as probably getting new TILs into the tumors is important, it’s probably more important to change the makeup of those cells into a more productive immune response positive phenotype. That’s exactly what we see with when you get bavituximab treatment; when we take a look a look at our translational data it shows an increase in CD4+ T-Cells and an increase in CD8+ T-Cells along with the changes in the suppressive cells types and the expression of immuno-suppressor cytokines, in which both decrease after treatment. So, it’s a matter of getting everything moving in the right direction. Again this is the role we think PS plays, by blocking it and activating an immune response, we're able to turn that around.
RJ: ”That does make sense. I think you’re looking at patient selection as being helpful in defining the population as well as the data you showedat SITC'15 [11-9-15/Duke's Herbert K. Lyerly http://tinyurl.com/pbof95w ], where you talked about immuno-profiling and looking at response to bavituximab, those are very interesting datasets. The other question I have is, there are a couple of trials running that are ISTs [at UTSW] - one of them is bavi in combination with Yervoy(ipilimumab) in melanoma, and the other one is a rectal cancer IST. Any updates on those?”
Steve King: The Rectal adenocarcinoma, we expect to have some data coming up this year from that study. As in any IST, it’s always a bit difficult, we do whatever we can to encourage them. But we do expect data to be becoming out of that study in 2015, which I think will be a real positive because in that study we did have the opportunity to collect pre- and post-treatment biopsies - #1, so we can see what happens following bavituximab treatment, but also that was a combination with radiation which we expect to be a very strong inducer of tumor antigens, which can then be taking advantage of by bavituximab treatment to make CD8+ T-Cells or killer T-Cells. For the Melanoma study, obviously the since that investigator (UTSW) started this study the SOC has changed pretty substantially. So right now, we're trying to work with that investigator, as well as some others, to probably change the profile of that study or start a new multi-center study in which we can then look at little bit more closely at what is the current SOC and make sure it’s an attractive trial for patients. As the treatment options for patient’s change, you need to be able to change with it and luckily it's a small IST trial and we may have an opportunity here to run a trial that I think would be very attractive for patients and will allow us to answer some key questions, because that was really the point of that study was to answer some of the key questions of combining with Yervoy. In addition, we’re starting the combination of durvalumab [AZN collab.] in multiple solid tumor types after the beginning of the year, so one way or another we’ll have lots of information coming from those studies.
RJ: ”Any updates any more color or comments on the collaboration with Sloan Kettering and Jed Wolchok on combination approaches - any data coming that way in the next few months?”
Steve King: That's an ongoing process. We’re very actively working with them to study a new combinations, looking for potential and different indications as well as those different combinations. We fully expect that it will be a fruitful collaboration; there will be a lots of data coming from that that we’ll see a very scientific meetings coming up. We already see a lot of data coming out of all for other collaborators nad we’ve had examples of presentations in multiple conferences this year. It always takes a while for them to get started, but then once they are going you tend to have a lot of data that continuously comes through them because the all the systems are up and running.
RJ:”Great.Thank you and congratulations on the healthy revenues at Avid.”
MR. KING’S CLOSING COMMENTS:
I’d like to thank all of you for participating in today’s phone call. As always, I want to especially thank our stockholders for their continued support, our mfg. clients for their continued business, and as always our patients and their families that are participating in our bavituximab clinical trials. With that, we will now conclude the call.
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12-10-15 PR: ”Peregrine Pharmaceuticals Reports Financial Results for 2ndQuarter of FY2016 2016 and Recent Developments”
* Peregrine and AstraZeneca Expand Immuno-Oncology Collaboration and Plan Phase II NSCLC Trial
* Phase III SUNRISE Clinical Trial Expected to Complete Enrollment in Coming Weeks While New Clinical Trials Are Being Initiated
* Peregrine Closes $20mm Financing to Support Late-Stage Clinical Trials
* Biomanufacturing Business, Avid Bioservices, Posts Strong Quarter With a 52% Increase in Revenue
* New State-of-the-Art Production Facility Ready for Initial Phase of GMP Manufacturing
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=946616
TUSTIN, Dec. 10, 2015: Peregrine Pharmaceuticals, Inc. (NASDAQ: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 2nd quarter of FY2016 ended October 31, 2015, and provided an update on its advancing clinical pipeline and other corporate developments.
Highlights Since July 31, 2015
"I am pleased to report that we are nearing completion of enrollment for our Phase III SUNRISE trial with over 90% of the intended number of patients enrolled. We have also made substantial progress toward initiating several new trials including a Phase II/III breast cancer study and a Phase II NSCLC trial in combination with AstraZeneca's anti-PD-L1 antibody, durvalumab," said Steven W. King, President and CEO of Peregrine. "Our goal is to transition our leading SUNRISE clinical sites into our new Phase II NSCLC trial which should significantly expedite study start-up activities. We are encouraged by the fact that a number of investigators from hospitals that participated in the SUNRISE trial have already enthusiastically agreed to participate in our upcoming NSCLC trial."
"As treatment paradigms shift to incorporate new drugs, it is clear that both chemotherapy and immuno-oncology agents will continue to be critical to patient care. Taken together, we believe our SUNRISE trial, as well as the newly planned breast and lung cancer trials will allow us to maximize the potential of bavituximab in both settings," said Joseph Shan, VP of Clinical & Regulatory Affairs of Peregrine. "We are committed to continuing to identify new potential indications, patient populations and therapies that can benefit from combination treatment with bavituximab. From what we have seen to date in our preclinical and translational studies, the opportunity appears vast, and we are hard at work converting the most promising prospects into true value."
Clinical Development Highlights
As of today, more than 90% of the planned number of patients have been enrolled in the Phase III SUNRISE trial, representing a sufficient number of patients required to trigger the two pre-planned interim analyses as well as the final analysis for trial unblinding. The company expects to reach the trial's estimated enrollment of 582 patients in the coming weeks.
Peregrine and AstraZeneca expanded their cancer immunotherapy clinical trial collaboration to evaluate bavituximab in combination with AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736). The companies are currently planning a global Phase II study in patients with previously treated squamous or non-squamous NSCLC, as well as a Phase I/Ib trial that will evaluate the safety and efficacy of bavituximab in combination with durvalumab and chemotherapy in multiple solid tumors. The company expects the Phase II study to be initiated in early 2016 with the Phase I/Ib study beginning later in 2016.
Peregrine continues to finalize plans for its Phase II/III trial to evaluate bavituximab with chemotherapy combinations in HER2-negative metastatic breast cancer. This trial is on track to be initiated by the end of calendar year 2015.
Supportive Research Highlights
Positive results were presented at the 2015 annual meeting of the Society for Immunotherapy of Cancer (SITC) [11-9-15: SITC'15 'New Bavi+Checkpoint Inhibitors preclin. data (UTSW/DUKE's Herbert K. Lyerly) http://tinyurl.com/pbof95w ] 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.
New data presented at the International Association for the Study of Lung Cancer's (IASLC's) World Conference on Lung Cancer (WCLC) [9-8-15: Scott Antonia/MoffittCC IASLC’15 Mini-Oral Presentation Slideshow http://tinyurl.com/p9eduac ] from a translational study of bavituximab demonstrated the ability of bavituximab, alone or in combination with docetaxel, to induce signs of immune activation in non-small cell lung cancer (NSCLC) patient-derived tumor samples, particularly when there was negative PD-L1 expression in the tumor sample. These data further support the potential mechanistic synergies for bavituximab with chemotherapy and checkpoint inhibitors targeting the PD-1/PD-L1 pathway.
Summary data presented at the Combination Immunotherapy Strategies session at the 10th Annual Immunotherapy and Vaccine Summit (ImVacS) [8-26-15: ImVacS'15 http://tinyurl.com/qz64pzg ], highlighted key findings from several recent bavituximab-focused studies including: the potential of bavituximab to shift the tumor microenvironment from immuno-suppressive in which tumors evade immune detection to a state of immune activation in which the immune system recognizes and fights the tumor; bavituximab's potential to increase the number of activated CD8+ cells in the tumor, which stimulates PD-1 expression, potentially increasing the number of patients able to respond to PD-1 and PD-L1 targeting immunotherapies; and, results from several clinical and preclinical studies in a range of tumor types showing that bavituximab and bavituximab-like antibodies, in combination with conventional therapy, have consistently demonstrated Kaplan-Meier graphs that follow the classic immunotherapy survival plateau.
Corporate Highlights
Peregrine closed a registered direct offering to a single institutional investor raising $20mm dollars [10-30-15: Kenneth Dart (Eastern Capital) acquires 13.1% stake (30,106,945sh.) in PPHM http://tinyurl.com/24qctos ]. The funds raised from this financing will support the ongoing Phase III SUNRISE trial, and newly planned later-stage company-sponsored trials in breast cancer and NSCLC.
Avid Bioservices Highlights
"Our contract manufacturing business continues to strengthen with a 52% current quarter increase in revenue compared to the prior year period and year-to-date growth of 61%," stated Paul Lytle, CFO of Peregrine. "Our new state-of-the-art manufacturing facility is now ready for the initial phase of GMP manufacturing and demand for Avid's capacity continues to grow with our current backlog now at $49mm. Given the revenue growth and committed backlog, we are increasing our contract manufacturing revenue guidance to a range of $35 to $40mm for the full-year 2016."
During the second quarter of FY 2016, Avid Bioservices achieved record-breaking revenues generating approximately $9.5mm dollars, a 52% increase in revenue compared to the same quarter in the prior year.
Avid's new manufacturing facility is now ready for the initial phase of GMP manufacturing. The state-of-the-art facility will accommodate single use bioreactors (SUBs) at up to 2,000 liter scale. Upcoming production runs will support late stage clinical development as well as process validation activities in anticipation of bavituximab and other client commercial product needs. The facility has the capacity to potentially generate approximately $40mm in new revenue annually.
Contract manufacturing committed backlog reached $49mm from existing customers covering services to be completed in FY 2016 and into FY 2017.
Financial Results
Total revenues for the second quarter of FY 2016 were $9,523,000, compared to $6,300,000 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 second quarter FY 2016 were $9,523,000, compared to $6,263,000 for the same quarter of the prior fiscal year. Peregrine expects third-party contract manufacturing revenue for the entire fiscal year to be between $35mm and $40mm, compared to previous guidance of $30mm to $35mm during last quarter's earnings call. In addition to providing biomanufacturing services to its third-party clients, Avid will continue to support the clinical development and potential commercialization of bavituximab.
Total costs and expenses in the second quarter of FY 2016 were $23,347,000, compared to $18,437,000 in the second quarter of FY 2015. This increase was primarily attributable to current quarter increases in research and development expenses associated with the SUNRISE Phase III trial, newly planned later-stage company-sponsored trials in breast cancer and NSCLC, and an increase in the cost of contract manufacturing associated with higher reported revenue. For the second quarter of FY 2016, research and development expenses were $14,190,000, compared to $10,003,000 for the second quarter of FY 2015. For the second quarter of FY 2016, cost of contract manufacturing was $4,741,000, compared to $4,139,000 for the second quarter of FY 2015.
Peregrine's consolidated net loss attributable to common stockholders was $14,578,000, or $0.07 per share, for the second quarter of FY 2016, compared to a net loss attributable to common stockholders of $13,131,000, or $0.07 per share, for the same prior year quarter.
Peregrine reported $72,005,000 in cash and cash equivalents as of October 31, 2015 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/zdbo9rv ]
Conference Call
Peregrine will host a conference call and webcast this afternoon, December 10, 2015, at 4:30 PM ET (1:30 PM 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 with a pipeline of novel drug candidates in clinical trials focused on the treatment of cancer. The company's lead immunotherapy candidate, bavituximab, is in Phase III development for the treatment of previously treated non-small cell lung cancer (the "SUNRISE trial") along with several investigator-sponsored trials evaluating other treatment combinations and additional oncology indications. 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 .
Safe Harbor *snip*
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
(UNAUDITED)
THREE MONTHS ENDED
OCTOBER 31,
SIX MONTHS ENDED
OCTOBER 31,
2015 2014 2015 2014
REVENUES:
Contract manufacturing revenue $ 9,523,000 $ 6,263,000 $ 18,902,000 $ 11,759,000
License revenue - 37,000 292,000 37,000
Total revenues 9,523,000 6,300,000 19,194,000 11,796,000
COSTS AND EXPENSES:
Cost of contract manufacturing 4,741,000 4,139,000 9,349,000 7,722,000
Research and development 14,190,000 10,003,000 28,108,000 20,204,000
Selling, general and administrative 4,416,000 4,295,000 9,315,000 9,178,000
Total costs and expenses 23,347,000 18,437,000 46,772,000 37,104,000
LOSS FROM OPERATIONS (13,824,000 ) (12,137,000 ) (27,578,000 ) (25,308,000 )
Interest and other income 626,000 37,000 657,000 79,000
NET LOSS $ (13,198,000 ) $ (12,100,000 ) $ (26,921,000 ) $ (25,229,000 )
COMPREHENSIVE LOSS $ (13,198,000 ) $ (12,100,000 ) $ (26,921,000 ) $ (25,229,000 )
Series E preferred stock accumulated dividends (1,380,000 ) (1,031,000 ) (2,413,000 ) (1,802,000 )
Net loss attributable to common stockholders $ (14,578,000 ) $ (13,131,000 ) $ (29,334,000 ) $ (27,031,000 )
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:
Basic and Diluted 203,942,411 179,962,275 200,629,892 179,540,265
BASIC AND DILUTED LOSS PER COMMON SHARE $ (0.07 ) $ (0. 07 ) $ (0.15 ) $ (0.15 )
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
OCTOBER 31,
2015 APRIL 30,
2015
Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 72,005,000 $ 68,001,000
Trade and other receivables, net 2,904,000 3,813,000
Inventories 12,554,000 7,354,000
Prepaid expenses and other current assets, net 1,995,000 1,355,000
Total current assets 89,458,000 80,523,000
Property and equipment, net 21,764,000 15,124,000
Other assets 1,435,000 1,817,000
TOTAL ASSETS $ 112,657,000 $ 97,464,000
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 6,901,000 $ 10,385,000
Accrued clinical trial and related fees 6,138,000 3,910,000
Accrued payroll and related costs 4,130,000 4,606,000
Deferred revenue 9,688,000 6,630,000
Customer deposits 14,935,000 11,363,000
Other current liabilities 667,000 437,000
Total current liabilities 42,459,000 37,331,000
Deferred rent, less current portion 972,000 1,098,000
Commitments and contingencies
STOCKHOLDERS' EQUITY:
Preferred stock - $0.001 par value; authorized 5,000,000 shares; issued and outstanding - 1,577,440 and 1,574,764, respectively 2,000 2,000
Common stock - $0.001 par value; authorized 500,000,000 shares; outstanding – 225,824,551 and 193,346,627, respectively 226,000 193,000
Additional paid-in capital 549,543,000 512,464,000
Accumulated deficit (480,545,000 ) (453,624,000 )
Total stockholders' equity 69,226,000 59,035,000
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 112,657,000 $ 97,464,000
• 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 Dec. 9, 2015, there were 229,701,808 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 10-31-15 iss. 12-10-15 http://tinyurl.com/zdbo9rv PR: http://tinyurl.com/jkp885g (Cash 10-31-15=$72.0mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
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= = = = = = = = = = = = = = = = = = = = = = = = = = = =
Updated PPHM REVS-BY-QTR TABLE, now thru FY16'Q2(qe 10-31-15), per the 10-31-15 10-Q ( http://tinyurl.com/ocrtkuj ) issued 12-10-15.
• Total Revs since May’06: ($148.1mm/Avid + $24.1mm/Govt + $2.4mm/Lic.) = $174.7mm
• Deferred-Revs at 10-31-15, going fwd into FY’16/Q3 (q/e 1-31-16), total $9.7mm, UP from the $8.3mm of Deferred-Revs at 7-31-15 that drove into FY’16/Q2.
• Cust.Deposits at 10-31-15 total $14.9mm, UP from $9.6mm at 7-31-15.
• Avid’s Gross-Profit over last 3 qtrs: $14.1mm on revs of $28.2mm (GP%=50%)
• Recall, Avid Rev$ 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%
FY13 TOTAL: 21,333,000 12,595,000 8,738,000 41%*
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%
FY14 TOTAL: 22,294,000 13,110,000 9,184,000 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%
FY15 TOTAL: 26,744,000 15,393,000 11,151,000 42%*
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%
*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
Totals: 148114 24149 2416 174679 <=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): $24.15mm
.
AVID “Total Services”:
AVID OUTPUT$ 3rd-PARTY + PEREGRINE = TOTAL-OUTPUT$
FY09 4-30-09 13mm 10mm $23mm #
FY10 4-30-10 13mm 17mm $30mm #
FY11 4-30-11 9mm 11mm $20mm @
FY12 4-30-12 15mm 11mm $26mm @
FY13 4-30-13 21mm ~10mm ~$31mm ^
LTM ended 1/2010 3rd/$15.3mm + Govt/$8.3mm + PPHM/$8.8mm = $32.4mm *
@SKing 3-18-2013 RothOC/DanaPT (Slide21) http://tinyurl.com/cebtwen
#SKing 7-12-2012 JMP/NYC Conf. (Slide27) http://tinyurl.com/csdclwb
*SKing 3-17-2010 RothOC/DanaPT Conf. (Slide18) http://tinyurl.com/ye9v7jq
^PLytle 7-11-2013 Qtly-CC “Avid did ~$10mm in equivalent services for Peregrine in FY13, which doesn’t get reflected into the fin. statements, it's eliminated in consolidation.”
.
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
= = = = = = = =
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)
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.”
.
- - - - - - - - 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)
= = = = = = = = = = = =
“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
= = = = = = = = = = 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."
= = = = = = = = = = = = = = = = = =
11-9-15 SITC'15: New Bavi+Checkpoint Inhibitors preclin. data (UTSW/DUKE's Herbert K. Lyerly) http://tinyurl.com/pbof95w
...Also, collab. with Dr. Bernard Fox (Immunotherapist/Earle A. Chiles Res.Inst.) on new Immuno-Profiling Clinical Test (Opal 6-plex quantitative IF Assay), PPHM roundtable with Raymond Birge (Rutgers), Douglas Graham (Emory), Dmitry Gabrilovich (Wistar), Rolf Brekken (UTSW), Maria Karasarides (AstraZeneca) - ”Combining Bavi w/anti-PD-1 significantly enhanced O/S… significant incr. CD45+, CD8+ and CD3+ T-cells… led a prolonged anti-tumor immune response which protected the animals against a re-challenge w/same tumor.”
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
9-9-15 Qtly. Conf. Call (King/Shan/Worsley/Lytle) Transcript http://tinyurl.com/ph22vdn
...CEO S.King: “The Memorial Sloan Kettering & AstraZeneca collaborations are an important part of our announced plans to expand our bavituximab clinical pgm.”
8-26-15: Jeff Hutchins(VP/PreClin-Res) ImVacS’15 Talk – 29pg. Slideshow http://tinyurl.com/qz64pzg
…“Expansion & Activation of T Cells via the Targeting of the Immunosuppressive Ligand PS: Combination Strategy with Conventional, Targeted, and Checkpoint Inhibitor Therapy”
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
7-14-15 Qtly. Conf. Call (King/Shan/Hutchins/Lytle) Transcript http://tinyurl.com/nw2v5u6
...CEO S.King: “We recently entered into collaboration with investigators at Memorial Sloan Kettering Cancer Ctr to continue expanding on this important work, as well as to explore other potential applications of bavituximab and other agents that target PS-signaling pathway.”
BAVI MOA 8-26-15: Jeff Hutchins(VP/PreClin-Res) ImVacS’15 Talk – 29pg. Slideshow http://tinyurl.com/qz64pzg
…“Expansion & Activation of T Cells via the Targeting of the Immunosuppressive Ligand PS: Combination Strategy with Conventional, Targeted, and Checkpoint Inhibitor Therapy”
5-31-15: ASCO’15 Roundtable (webcast), “Raising the Immuno-Oncology Bar” - 7 panel members, incl. 3 Sloan Kettering researchers http://tinyurl.com/qxu4w2x
BAVI MOA 3-25-15: PPHM/VP Dr. Jeff Hutchins’ presentation at "Immune Checkpoint Inhibitors Conf.", Boston - PDF(34 Slides): http://tinyurl.com/ooxkhq7
BAVI MOA 2-9-15: PPHM/VP Dr. Bruce Freimark’s presentation at KEYSTONE "Tumor Immunology Meeting", Banff/CN – PR & Slides: http://tinyurl.com/q6cx4w6
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