Avid Bioservices Inc (CDMO)

[cjgaddy]

9-9-15 Qtly CC-Transcript, PR(Fins/Devs Q1FY16/qe7-31-15), updated Avid Revenues History Table By Quarter…
=> Total Revs May06-Jul15: $138.6mm/Avid + $24.1mm/Govt + $2.4mm/Lic. = $165.2mm

This large post has 3 sections:
I. 9-9-15 Q1/FY16 Qtly. Earnings Conf. Call TRANSCRIPT (q/e 7-31-15)
II. 9-9-15 PPHM Press Release: Q1/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/q8bgmcz ], with numerous corrections made. )))
Link to webcast replay:
http://ir.peregrineinc.com/events.cfm => http://edge.media-server.com/m/p/2h8985bu
FULL TRANSCRIPT…
9-9-2015 FY’16/Q1 Earnings Conf. Call (q/e 7-31-15)
WELCOME & FWD-LOOKING STATEMENTS: Tim Brons, Vida Strategic Partners (IR) http://www.peregrineinc.com
Speakers: Steve King, Joe Shan, Stephen Worsley, Paul Lytle; Q&A session.

CEO STEVE KING – OPENING COMMENTS:
Thanks to all of you who have dialed in, and to all of you who are participating via webcast today. FY’2016 [May’15-Apr’16] is off to a great and busy start at Peregrine. In May, we announced a research collaboration with leading immuno-oncology researchers at the Memorial Sloan Kettering Cancer Center. In June, we presented important translational data at ASCO, showing the potential of bavi to enhance immune responses in PD-L1 negative tumors. In July, we reported that our Phase III SUNRISE trial in NSCLC remained on track for normal completion by year-end, and as we draw closer to December, we are increasingly confident that we will hit this milestone. And most recently we announced collaboration with AstraZeneca to expand our immuno-oncology combination clinical research program.

The Memorial Sloan Kettering & AstraZeneca collaborations are an important part of our announced plans to expand our bavituximab clinical program. The initial efforts is to initiative new Lung & Breast cancer clinical trials by year-end, and then to expand to new addl. indications by early 2016. Taken together, these clinical efforts are meant to expand bavituximab's eventual market opportunity in NSCLC by providing important data supporting the combination of bavituximab with both chemotherapy and PD-1 or PD-L1 inhibitors, while simultaneously pursuing equally large market opportunities in Breast cancer and eventually other indications.

Fueling these efforts, our research group remains busy generating clinical, translational, and preclinical study results that consistently demonstrate bavituximab's activity in a range of tumor types. In recent weeks, we've received very positive responses to findings presented at the Intl. Association for the Study of Lung Cancer (IASLC) World's Congress [WCLC] and at the Immunotherapy & Vaccine Summit [ImVacS]. At these meetings, we presented results from multiple studies demonstrating bavituximab's ability to promote anti-tumor T-Cell-mediated activity and its potential mechanistic synergies with chemotherapy & checkpoint inhibitors targeting the PD-1 & PD-L1 pathways.

Finally our contract mfg. business, Avid Bioservices, hit a record high for revenues for any quarter [$9.4mm, GP%=51%] during Q1/FY’16, putting us on track for another record revenue year. I'll continue my comments later, but first the other members for our team will give a detailed overview of our clinical, business development, and operational achievements. We will begin with Joe Shan, VP/Clinical&Regulatory.

JOE SHAN (VP/Clin.&Reg. Affairs) – CLINICAL TRIALS:
I'd like to start with an update on the company's ongoing Phase III SUNRISE trial, which is evaluating the use of bavituximab & docetaxel in patients with previously treated locally advanced or metastatic non-squamous NSCLC. This global study remains our top clinical priority and I'm happy to say this trial is proceeding according to plan and we continue to stay on target to complete accrual by the end of the calendar year. As a reminder, SUNRISE is designed as a blinded registration trial with 2 planned interim analyses. The 1st will be conducted when 33% of the targeted survival events are reached, and the 2nd will be conducted at 50% of events. As these events are patient deaths, we are at this time unable to accurately predict when the interim analyses will occur, but we plan to provide updates as soon as possible.

Meanwhile as SUNRISE nears the completion of enrollment and we await the trial results, we have begun to expand the bavituximab clinical program and are planning to initiate several new trials in the coming months to identify other clinical settings where the addition of bavituximab might help improved patient outcomes. Our strategy behind this decision is to continue building on our significant clinical experience, combining Bavituximab with chemotherapy, while simultaneously exploring new opportunities with immunotherapy combinations.

Let me first address the expansion of our NSCLC program beyond the combination with docetaxel, which we believe will remain a key treatment option in a number of cancers, including Lung cancer. The decision to initiate another Lung cancer trial is supported by the considerable amount of preclinical data demonstrating that treatment effects of CTLA-4 or PD-1 inhibitors is greatly enhanced when combined with Bavituximab. This is very timely as anti-PD-1 agents such as nivolumab ( Opdivo) & pembrolizumab ( Keytruda) are starting to enter the market as single agent therapies. Thus, we're planning to initiate around the end of this year an open-label, randomized Phase II trial of nivolumab vs. nivolumab+bavituximab in patients with previously treated metastatic NSCLC who have not received a prior PD-1 or PD-L1 inhibitor. The primary endpoint of this trial is expected to be overall response rates with secondary endpoints to include duration of response, progression-free survival, overall survival, and safety. Importantly, as translational studies have demonstrated that bavituximab enhances multiple markers of immune activation even in tumors that express low levels of PD-L1, we plan to look at patient outcomes by pre-treatment PD-L1 expression levels to better understand which patients benefit most from bavituximab's effects.

Now beyond Lung cancer, we are also compelled to initiate addl. clinical trials in Breast cancer based on the totality of our clinical experience in advanced Breast cancer to-date. Data from our Phase I IST of bavituximab+paclitaxel in patients with HER2- metastatic Breast cancer published in Cancer Medicine earlier this year [3-31-15/A.Stopeck http://tinyurl.com/nm5oog4 ] demonstrated an impressive 85% response rate. Data from this IST, together with 2 prior Peregrine sponsored trials of bavituximab with taxane-based chemotherapy which yielded between 61% to 74% overall response rates and a MOS of over 20mos. in advanced or metastatic Breast cancer patients provides strong rationale to advance this indication. Additionally, taxanes continue to be a key std. treatment option for many stages of Breast cancer. Accordingly, we plan to initiate a seamless Phase II/III trial in patients with HER2- negative metastatic Breast cancer, with all patients receiving physician's choice of paclitaxel or docetaxel, either alone or in combination with bavituximab. The primary end point for Phase II is overall response rate, while the Phase III part of the trial has a primary end point of progression-free survival.

Furthermore we are 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 signal in early stage HER2- Breast cancer. As with the Phase II lung cancer trial described earlier, we plan to initiate the Phase II/III Breast trial before the end of this year. The open-label nature of these trials may provide us the opportunities for data updates, and our goal is to generate as much clinical data as possible prior to SUNRISE unblinding.

Now last but not least, I'd like to finish up with a few words about our recent collaboration announcement with AstraZeneca [8-24-15: http://tinyurl.com/owlxpsf ]. Under this clinical collaboration agreement, we will combining bavituximab with chemotherapy and AZ's durvalumab [aka “MEDI4736”, an anti-PD-L1 inhibitor] in a Phase I/Ib trial 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 regiment for the Phase Ib part of the trial, which will assess the safety & activity of the triple investigational combination, which includes std. chemotherapy. We are particularly excited about the collaboration because we believe that these 3 drugs have different and potentially complementary mechanisms. Chemotherapy is known to kill tumor cells, increase phosphatidylserine exposure and generate tumor antigens. Bavituximab, by targeting exposed PS, a highly immune-suppressive molecule exposed on the surface of cells in the tumor micro environment, has been shown to trigger macrophage re-polarization and tumor specific T-Cell activation. Durvalumab is a monoclonal antibody directed against programmed cell death ligand 1 PD-1 and signals from PD-1 help tumors avoid detection by the immune system. We believe that by combining these 3 approaches the potential exists for a more complete and lasting anti-tumor immune response and look forward to testing this hypothesis in the clinic. And to provide more context regarding the AZ collaboration and Peregrine’s ongoing business development efforts, I'll turn the call over to Steve Worsley.

STEPHEN WORSLEY (VP/Business Dev.):
All of our foundational of science and positive clinical results consistently point us to bavituximab's potential as a high value, next generation anti-cancer agent, and in the last 3mos. these achievements have compelled others to align with us as we continue to develop bavituximab.

In May, Peregrine announced an exciting collaboration with Memorial Sloan Kettering Cancer Center [5-29-15: http://tinyurl.com/qxu4w2x ] to evaluate combinations of bavituximab with other checkpoint inhibitors and immune stimulatory agents for the purpose of developing new & increasingly effective anti-cancer treatments. Only 3mos. months later, we announced a new collaboration with AstraZeneca [8-24-15: http://tinyurl.com/owlxpsf ] to evaluate bavituximab in combination with AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab also known as MEDI4736, in multiple solid tumors.

By aligning with these world leaders to develop novel immuno-oncology combination therapies, we are positioning ourselves to maximize the potential role that bavituximab can play in this new era of innovative immuno-oncology [I-O] treatments. We believe these collaborations validate the promise of bavituximab and are indicative of the well-validated science we are conducting at Peregrine. We are in the fortunate position to have full rights to this valuable Phase III asset. We believe with the substantial scientific support and compelling data, bavituximab will continue to bring world leading organizations to the partnering table. 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:
Let me shift gears now and give you a brief overview of our financials. Peregrine continues to carefully weigh its opportunities & expenditures with its current cash and financing options. Our strategic investment in the Avid Bioservices business is already starting to pay dividends. Our clients are reserving mfg. slots in the new facility, which has increased our revenue backlog to approx. $42mm. In addition to our backlog, current qtr revenue hit an all-time high at $9.4mm, representing a 71% increase in revenue compared to the same prior year qtr. For the full FY2016, we expect mfg. revenues to increase to a range of $30-35mm. We also believe this business has more opportunity to grow, as our 2nd mfg. facility has the capacity to generate approx. $40mm in new revenue. The new mfg. suite is fully built and the 1st internal pilot run is currently underway to verify all systems & equipment are properly functioning. We plan to announce the official launch of the facility in the near-term, which meets both our internal mfg. timelines and those of our clients. As mentioned on previous calls, the non-dilutive income generated from our mfg. operations 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 manufacturing cost.

Now turning to expenses, R&D expenses for the qtr increased as we continue to invest in our Phase III SUNRISE trial, while SG&A expenses remained flat qtr-over-qtr. A more detailed analysis of our statement of operations is included in our Form 10-Q that was filed today [ 9-9-15 10-Q: http://tinyurl.com/pemub47 ]. This concludes my financial overview. Now I’ll turn the call back over to Steve to discuss some important upcoming milestones.

CEO STEVE KING – MILESTONES:
It’s only been 8 weeks since we last reported our financial results and development progress, yet in this short time much has been done. We remain on track to complete enrollment in our cornerstone SUNRISE trial, and based on the compelling data we’ve seen to-date from other clinical, translational, and pre-clinical research we are deep into planning for our next set of trials in NSCLC & Breast cancers. Our pre-clinical work continues to provide an ever expanding understanding about the expense mechanism of action, and importantly it is leading us to identify the most promising therapeutic combinations with other immune stimulatory agents, ensuring that bavituximab will play a critical role in the treatment of cancer, regardless of which protocols are in use. These study results, particularly as they relate to the potential synergies between bavituximab and checkpoint inhibitors, create great excitement for us as we begin and continue work with our new collaborators at Memorial Sloan Kettering Cancer Center and AstraZeneca, while we continue our long standing relationship with the Univ. of Texas SW Medical Center, where this technology was originally developed. We look forward to initiating new collaborations, completing enrollment in our SUNRISE trial, beginning dosing in our new NSCLC cancer and Breast cancer studies, and announcing the opening of Avid’s new mfg. site, all in the next few months. These are exciting times for Peregrine and we will continue to keep you posted on all these projects as we make progress.

Q&A: [17:20 mark]

1. Joe Pantginis – Roth Capital Partners: [ http://www.roth.com & https://roth2.bluematrix.com/docs/pdf/BLUE.pdf ]
JP: ” I’d like to focus 1st on the Lung cancer area. With SUNRISE, have you seen any impact with regard to the recent approval of Opdivo for enrollment in this study?”
Steve King: I can take a first stab at that and then Joe can jump in. Basically, we haven't really seen any impact of it in the enrollment itself. Obviously these drugs are just now coming on the market or even aren't yet available for reimbursement, so at this point it hasn’t been a much of an issue. On the other side of it, it opens up in our new studies the combination potential in those indications where now insurance can help pay for those drugs as a standard of care. So, based on the timing of when we anticipate completing the study and the fact that this is the worldwide study including not just sites in the U.S. but actually the majority of our sites are in Europe and in the Asia-Pacific region, we don't anticipate this will be a hindrance for us completing enrollment on the scheduled timeframe by the end of the year.
JP: “The lung cancer treatment landscape with the Opdivo approval is evolving pretty quickly. So how do you see Bavi fitting into that landscape?”
Steve King: That’s a great question. We view that chemotherapy is still going to be a major part of the way cancer patients are treated, and that's in NSCLC, as well as other indications. So, I think while the order in which drugs are used may change over time, eventually the immuno-oncology agents may end up in a frontline setting. We really feel like bavituximab is in an excellent position because we will have the data coming from the SUNRISE study, supporting the effectiveness with docetaxel, which is one of the std. treatment paradigms in 2nd-line NSCLC. But also, the new study we're initiating by year end, in which we're combining with Opdivo, will then give us we think a nice set of data coming in the immuno-oncology combination. So, as everything sorts itself out and new agents come into the marketplace, then we'll be in a good position for combining with either one of those treatment modalities. Joe, do you want to expand?
Joe Shan: Much like in the melanoma space, the initial approvals of immuno-oncology agents are as single agent therapies. But, you can see there is obviously a lot of combination work being done, and I think that's where bavituximab is really uniquely positioned in our mechanism can really complement a host of different other mechanisms. The tolerability of the compound in our trials to-date lends itself to be combined with different therapies. So, I think there are going to be a lot of opportunities for making other products work better.
JP: ”In addition to AstraZeneca, what addl. types of partnerships or collaborations are you targeting at this point?”
Steve Worsley: What we're looking to do is to do fundamentally more of the collaborations like we formed with AstraZeneca - partnering, which we cannot speculate on right now due to forward projection – it’s certainly within the wheelhouse of the organization. We will and have seen quite an uptick with regards to the activities in companies looking at us because of these initial collaborations that we’ve set up this year. So we anticipate more of the same.
Steve King: Just to expand on that a little bit, our stated goal has been ex-U.S. partnering, to primarily keep as much of the U.S. rights as we can, and that remains intact. The reason obviously at this point of partnering is to allow us to expand what we are doing with bavituximab program. We’ve obviously got a number of new clinical studies we’ve identified as being important to start over the coming months, in order so that we can have the data from those studies by the time we unblind the SUNRISE study, but also to be able to run addl. studies in other combinations and other indications, because clearly that’s where the value of the program can be driven upward is through addl. indications and utilization of bavituximab across many different treatment paradigms.

2. Charles Duncan – Piper Jaffray [http://www.piperjaffray.com – 3-5-13 Initiates PPHM: http://tinyurl.com/bxhntk3 ]
CD: ”Congratulations on some of the recent research collaborations. Re: SUNRISE, thanks for the update that enrollment is on track to complete by yr-end. Joe, could you give us now, or plan to in the future, any sense of kind of blinded patient characteristics and geographic backdrop in terms of where those patients came from, any sense of how the enrollment is going with regard to previous lines of therapy et cetera?”
Joe Shan: I think we’re going to probably wait till at least after the 1st interim analysis and completion of our enrollment before announcing any kind of demographics on the trial.
CD: ”I know that it’s an event driven trial, but can you gauge at all when your sense is that you might get to that 1st interim of 33% of the events?”
Joe Shan: No, we can’t really guess right now.
Steve King: Charles, what we’ve been projecting is probably 1st-half of next year for the 1st interim data look, and then probably mid-year on for the 2nd interim data look and for the final unblinding - that’s based on sort of just general projections of how we expect the patients to do in the study overall. As we get further along, we’ll be able to get a little bit better guidance as we see more events take place and feel like we’re getting closer to those actual unblinding with interim data looks.
CD: ”That make sense to me and I appreciate the added color - good execution thus far. Re: the recent AstraZeneca deal, that level or types of diligence did they conduct and was the motivation the publication that came out roughly mid-year, or earlier this year, a key driver to that collaboration?”
Steve King: Steve & Joe can talk bit more about it, but in general it’s great to have a partner like AstraZeneca, who is essentially associating with us and wants to see how bavituximab may be able to impact the treatment paradigm with their particular PD-L1 inhibitor. And so I think that before any big company enters into those sort of collaborations, there is a significant amount of work that they do on their side to pick the right partners also, because there are lots & lots of opportunities for these big companies to collaborate with people, and so they want to make sure that they utilize their resources wisely as well. So, I think it was a great process; I think that it was really driven by a combination of some of the publications that have come out, but also by some of the data we’ve been presenting since last fall showing the real potential of bavituximab to enhance the potential number of patients that will respond to PD-1 or PD-L1 inhibitors. So, it’s really been a combination of the constant news flow we’ve had thats really driven that interest. Joe or Steve, do you want to add to that?
Steve Worsley: The thing with regard to due diligence is they [AstraZeneca] take these types of collaborations very seriously. There is a serious significant investment that they make in terms of investigating combination therapies out there, and again, don’t think that there is anything that’s out of the ordinary, but it was definitely a very exhaustive process they have conducted.
CD: ”Re: that current interaction, does that in anyway put them in a pole position for further interactions with you or is it simply, ‘let's do this experiment together?’”
Steve Worsley: I think it positions them [AstraZeneca] as an organization that is going to get used to working with our compound. By no means are they in a pole position for future partnering activities.
CD: ”But certainly they know you folks, they know what bavituximab could do and its mechanism and then how it interacts with their compound.”
Steve King: Yeah, I think that's the main advantage from their standpoint. We'll work very closely with them in this clinical trial as well as also discussing other potential types of collaborations and other trials and what have you, so it’s clear that proximity creates something of an advantage, but it's a wide open race.
CD: ”Re: Avid, you spoke about increasing capacity substantially here soon. Could you project any new collaborations partnerships, customer signings in the next 12mos. or so?”
Paul Lytle: Right now what we've said publicly is that our current guidance is $30-35mm for this FY. Obviously, Halozyme is one of our key anchor customers that represent a good portion of our revenue, and that supports both their Baxter & Roche collaborations, so it has opportunity to grow as they're successful too. The new facility will support the Bavituximab commercial launch in addition to providing growth for Avid's business, so we're excited about having that business there. We’ve had number of customers come through and inspect the operations and inspect the facility, and everybody believes it's a world-class facility, so we're excited to launch that here shortly.
Steve King: To add just a little more color on that, on the new facility, a lot of the interest comes from the existing client base, even as much as we've had new potential customers coming through. We’re very happy with the response to the new facility, and I think it really opens the door even for future additional expansion, if that's the direction we want to move. So, it's exciting, it's a real nice showpiece and it's really showing in the interest that it's generated from the existing client base.

3. George Zavoico – Jones Trading http://jonestrading.com
GZ: ”Good qtr certainly for Avid and the partnership and the collaboration. Re: the rapidly changing landscape with Opdivo & Krytruda in lung cancer which certainly probably multiplies the possibilities for combinations. But that also begs the question of the patients that are enrolled in SUNRISE, will you know for patients that are still being enrolled, what their PD-1/PD-L1 status may be, if that's part of the plan? Is that something you’re now starting to do now that those assays are becoming available?”
Joe Shan: Yes, that's something we're looking at in an exploratory fashion, George. We’re not requiring pretreatment biopsy specimens to get onto the study. It's on a volunteer basis, and we are collecting a significant proportion of patients' samples. So but we'll see at the end of the day is this enough to give us a hint that how predictive the primary assessments are at predicting outcomes.
GZ: ”How about in terms of going forward, like for example, when the patients begin these progressions and the subsequent therapies that the patients will then undergo after they’ve quit Bavi & docetaxel. Some of those patients might be tested for PD-L1 and go onto an immuno-oncology drug, Opdivo especially, and they may end up skewing or perhaps biasing somehow those sets of patients in survival post-SUNRISE. How do you look at that potential possibility?”
Joe Shan: We definitely collect what [???] patients go on, that’s standard for a survival, primary endpoint trial and you plan a multivariate analysis based on variables like that.
Steve King: A lot of this bias should be handled by the fact that it is a placebo-controlled study, so you would think those patients would equally fall into either of the arms of the study post being on the treatment in the SUNRISE study. As we go forward I think there are a lot of interesting things that we want to do with regard to the PD-L1 status, because from this translation data we were able to show at ASCO and around that time period this year really highlights the fact it may be actually PD-L1 negative tumors that we can have a significant impact in. And so, as we continue to go forward with the plan studies as well as other studies that are sort of more in the development phase, the ability to look at PD-L1 negative tumors and actually select for those patients, take a look at how they do on treatment with bavituximab, where we think we can enhance the effectiveness of a PD-1 or PD-L1 inhibitor is one trial design that I know has gotten a lot of interest. In addition, there is potential of, kind of the other way around, of eventually taking PD-1 refractory patients and actually then adding bavituximab to treatment regimen and seeing if we could convert those into responding patients. We’ll certainly be doing as much analysis as we can in the SUNRISE trial, sort of retrospectively, and looking for imbalances from what we can tell in the PD-1 & PD-L1 status.
GZ: ”Re: the [AZN] collaboration – you’re planning to increase the number of programs & trials you have going. This adds cost. Do any of these collaborations, AstraZeneca or MSK, providing any funds or is it going to be mainly funded by Peregrine? How much of non-dilutive cash might come in to help you with the AZ and the other trials that you are starting?”
Steve King: As part of the AZ collaboration, they are providing the drug itself, which is a huge cost benefit in this sort of trial, because it allows us, #1, full flexibility to start study as quickly as we can, and it takes the need to purchase any of the PD-1, PD-L1 inhibitors off the table. So, that's a significant benefit for their participation in the current collaboration. For us, again, one of the key drivers was the ability to get these studies started as soon as we can, because our bigger goal here is to be able to generate data by the time that we unblind the SUNRISE study, and the reason for that is, ‘planning for success’ - with good SUNRISE data and with addl. combination immunotherapy data in hand, it gives our regulatory group a lot more to work with when it comes to totally working with the FDA toward eventual label claims and what have you, as we look toward approval. For us right now, time is of the essence. As we go forward, we will be wanting to find probably more partners that can bring addl. funding to the table and help us to run studies, either from an operational standpoint, because again we have a relatively small internal group so we’re somewhat limited in the number of studies we can run simultaneously, but also some of the funding to take care of patient costs and what have you. At this early stage the most important thing for us was to have control of the study, be able to get it up and running because we feel the real value is getting this data in a timely fashion because of the value it can a add on the back end.
GZ: ”Re: the AZ study, have you guided at all when the first AZ study might start?”
Joe Shan: Not yet. We are working with the teams very closely to finalize the protocols, internal design right now. When we have a better handle on the operational timelines we’ll provide that.
GZ: ”The Memorial Sloan Kettering, those are mainly translation studies, correct?”
Steve King: Correct. That's the recent [MSK] collaboration that was announced. They are very active in the clinical space and they’ve got lots of good ideas for clinical studies. They've also got good relationships with a lot of the key players in the immuno-oncology space, within the PD-1/PD-L1 space specifically. So, we think that down the road they will be very active in both our clinical & preclinical research programs.
GZ: ”Great. Look forward the start of those trials and some of the data in upcoming conferences. Thank you.”

4. Rahul Jasuja - Noble Life Science Partners http://noblelsp.com/research
RJ: ”Thanks for taking my question and glad to know that PS is now being recognized by big pharma and the immunology mafia so to say. So couple of questions pertaining to how PS with checkpoint inhibitors is differentiated from the conventional checkpoints inhibitors, like the CTLA-4, PD-1, PD-L1 pathways. From the data that's been represented at ImVacS, and also in discussions they’ve had with you guys, besides blocking just PS binding to its receptors on immune cells, there is an FC- FC gamma -based effector function leading to ADCC and so on and so forth - an immune effector function that other checkpoint inhibitors do not have blocking PD-1 or blocking CTLA-4. So, you’ve got a component here that is beyond other checkpoint inhibitors, that brings in an effector function that others do not have. Looking at that aspect or looking at some of the translational data, do you think that beyond the PD-1, PD-L1 non-immunogenic tumors, there is a possibility that PS blockade will have far more effect potentially driving [ph??] antigen presentation. Any comments on that?”
Steve King: That’s a very important point you're bringing up. Because we're blocking an inhibitor, you still need an activating function to get an immune response started. It's a little bit different with PD-L1/PD-1 inhibitors, because there, you’ve basically brought up a marker to stop an active immune response. So, taking away the stopping of that immune response actually allows that continuing immune response to take place. But for the more upstream checkpoints, it's important to have that activating event, and in fact it's taking away the negative PS signal and then activating this T-Cell response which we think is such a great fit with PD-1 & PD-L1 inhibitors. Absolutely you're right, you need that activating event when you're taking off the breaks, if you will, upstream, because you still now need that trigger point for getting the immune response started, and so we're providing that with, as you said, the FC gamma receptor interaction.
RJ: ”And also the other question sort of stems from the fact that there is much said about connecting Adaptive with Innate immunity and there is a bunch of NK cell strategies in play as well. From the cytokine profiles and looking at the translational work that you guys presented at ImVacS in lung cancer [8-15-15 Dr. Jeff Hutchins http://tinyurl.com/qz64pzg ] , you're seeing interferon [???], IL-12, and other cytokines, and also converting M2 to M1 macrophages. How significant do you think your approach would be, because you could be connecting Innate to Adaptive, where other strategies do not really do that – some of the other strategies like [???], but no other checkpoint inhibitor does that. Any color on that aspect, where you could be connecting both the arms of the immune system, and deciding which tumors you're going to attack nd how the combination approaches may pan out?”
Steve King: I think you've made a great point, because what we're doing to this activating events in starting this immune response is basically taking away that natural defense the tumor has for stopping all immune responses, so that's both a native & adaptive killing of the tumor. We're really basically reversing that, probably equally on both sides of the equation, and we have good data that supports that. As you're pointing out, it really brings up a lot of new different types of combinations that we can pursue, and it's one of the reasons over the long run, our goal is, outside of PD-1, PD-L1, to combine with other immune-modulating technologies, and that could even include dendritic cell vaccines, other types of vaccine approaches, as well as the again the litany of different checkpoints that play a role downstream of our target. So, it really opens lot of doors for us, and, as Joe Shan alluded to earlier, one of the great things about bavituximab has been that it seems really very combinable so far with other agents. By having this good safety profile really allows us lot of opportunity on the combination front.
RJ: ”Great. On the SUNRISE trial, are you guys actually measuring all the cytokines that were measured in the translation work with the microspheres like IL-12, interferon gamma, IL-10, or all those not being measured for each patient?”
Joe Shan: Yes, that’s part of our exploratory endpoint, so we have a number of immune correlate testing, most of those are blood-based of course. So, yes, we do plan to look at changes in the cytokine levels. We've been working with some labs to develop ultra-sensitive assays.
Steve King: And it will also be a major part of lot of the new studies we are starting as well, because as we’ve learned more, even since we started the SUNRISE trial, we’ve now got the ability, with all the new translational data in hand, to really design some of these new studies with some of these addl. endpoints in mind – we’re looking at cytokine profiles, changes in macrophage profile, MDSE levels, all those things.
RJ: ”Great, thank you. That’s all I had guys.”
Steven W. King - President and CEO

5. Thomas Yip (MLV & Co.): http://www.mlvco.com
TY: ”…Congrats on a nice quarter, good to see Avid continues to grow. What would be considered a successful outcome for the Phase I/Ib trial that is in partnership with AstraZeneca?”
Joe Shan: I think first, we will need to establish the tolerability of the two investigational agents. So success would mean we can move into the triple combo setting and then just continue with kind of a basket design, where we look at several different tumor types, combining with the std. chemotherapy as well. They’re Phase I, so they’re uncontrolled studies, but these likely will be heavily pretreated patients. So, if we see some good responses, then that would be considered a signal and then we can always expand each cohort of the trial to other addl. tumor types.
Steve King: As in any of the basket studies, one of the nice things here is that we’ll have the ability to take a look at the PD-L1 status of the tumors as they go into treatment - do we see differences between PD-L1 negative, PD-L1 positive? So, alot of exploratory work can be done in this sort of trial design that we are looking at. And, I think, particularly for me, it’s exciting because we’ve gotten a lot of good clinical data combining bavituximab with chemotherapy, and this is a great opportunity to now expand that into that nice combination with a nice novel PD-L1 inhibitor to take a look at what a triple combination can do. I think that’s another huge benefit here, because particularly as we think about how the treatment landscape is going to change in various indications, still the majority of patients in most indications are not getting cured. So, the more we can figure out how to fit bavituximab in the different treatment regiments, we think the more value it will have overall in the program.
TY: ”Re: Avid, I see that the backlog is now ballooned to $42mm. Just wondering, what is the accounting treatment of that backlog increase, does it go to customer deposits or does it increase deferred revenue?”
Paul Lytle: Our typical contract requires an upfront deposit to secure that mfg. slot - that would actually go into customer deposits, and then once we kick off that mfg. run it gets booked into deferred revenue until that run is shipped, and then it moves into revenue. The $42mm in backlog right now covers work to be completed during FY’16 [May’15-Apr’16] and also into FY’17, so it's a combination of both years in terms of timing.
TY: ”Again, great to see Avid continue to grow and also while expanding bavituximab’s clinical footprint at the same time.”

MR. KING’S CLOSING COMMENTS:
I'd like to thank all of you again for participating in today's phone call. In closing, I would like to again express our enthusiasm around the bavituximab program and our growing biomanufacturing business. We are already helping other companies treat patients worldwide through our mfg. services, and we look forward to the potential that our own product, bavituximab, can play in helping the countless patients battling cancer worldwide by helping them to overcome the immune suppression so commonly found in the tumor environment. In closing, as always, I want to thank our stockholders for their continued support, and I’d like to especially thank our patients and their families that are participating in our bavituximab clinical trials. With that we will conclude the call.

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9-9-15 PR: “Peregrine Pharmaceuticals Reports Financial Results for Q1/FY2016 and Recent Developments”
• Peregrine and AstraZeneca to Collaborate on Immuno-Oncology Combination Clinical Trial
• Phase III SUNRISE Clinical Trial on Track to Complete Patient Enrollment by Calendar Year-End 2015
• Avid Bioservices Reports $9.4 Million in First Quarter Revenue
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=930887

TUSTIN, Sept. 9, 2015: Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company focused on developing therapeutics to stimulate the body's immune system to fight cancer, today announced financial results for the first quarter of fiscal year (FY) 2016 ended July 31, 2015, and provided an update on its advancing clinical pipeline and other corporate developments.

HIGHLIGHTS SINCE APRIL 30, 2015:
"Over the years, Peregrine's foundational science and positive clinical results have consistently pointed to bavituximab's potential as a high-value, next-generation anti-cancer agent," said Steven W. King, President and CEO of Peregrine. "In the last three months, these achievements have compelled others to align with us as we continue to develop bavituximab. In May, Peregrine announced an exciting collaboration with Memorial Sloan Kettering Cancer Center [5-29-15: http://tinyurl.com/qxu4w2x ] to evaluate combinations of bavituximab with other checkpoint inhibitors and immune stimulatory agents for the purpose of developing new and increasingly effective anti-cancer treatments. Only three months later, we announced a collaboration with AstraZeneca [8-24-15: http://tinyurl.com/owlxpsf ] to clinically evaluate bavituximab in combination with AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736) in multiple solid tumors. These collaborations with world leaders in immuno-oncology speak to the promise of bavituximab and validate our ever-growing enthusiasm for the investigational product. We look forward to advancing both of these programs and completing enrollment of our SUNRISE trial in the next few months."

CLINICAL DEVELOPMENT HIGHLIGHTS
Peregrine and AstraZeneca entered into a cancer immunotherapy clinical trial collaboration to evaluate bavituximab in combination with AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736). The planned Phase I/Ib trial will evaluate the safety and efficacy of bavituximab in combination with durvalumab in multiple solid tumors. Peregrine is working closely with AstraZeneca to finalize the trial design.

Phase III SUNRISE clinical trial in non-small cell lung cancer (NSCLC) continues to enroll patients and remains on track to complete patient enrollment by end of calendar year 2015.

Peregrine announced plans to expand the bavituximab clinical development program to include a Phase II trial to evaluate the combination of bavituximab and Opdivo® (nivolumab), an anti-PD-1 antibody, in previously treated, metastatic NSCLC [6-1-15: http://tinyurl.com/qxu4w2x ]. This trial is expected to be initiated by the end of calendar year 2015.

Peregrine announced plans to expand the bavituximab clinical development program to include a Phase II/III trial to evaluate bavituximab with chemotherapy combinations in HER2-negative metastatic breast cancer [6-1-15: http://tinyurl.com/qxu4w2x ]. This trial is expected to be initiated by the end of calendar year 2015.

SUPPORTIVE RESEARCH HIGHLIGHTS
Peregrine and Memorial Sloan Kettering Cancer Center entered into a research agreement [5-29-15: http://tinyurl.com/qxu4w2x ] to explore the potential of Peregrine's proprietary PS-targeting antibody platform. The goal of the research is to identify effective treatments combining bavituximab with other checkpoint inhibitors or immune stimulating agents.

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: 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) [ 8-15-15/Dr.J.Hutchins: 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 estimated survival curves that plateau.

Data from preclinical studies presented at the 2015 ASCO annual meeting [6-1-15: http://tinyurl.com/qxu4w2x ] demonstrated the ability of the company's PS-targeting antibodies to significantly increase the prevalence of tumor infiltrating CD8+ T-cells and immune-activating cytokines, while decreasing tumor-promoting macrophages and myeloid cells. These findings highlight the ability of the antibodies to enhance the anti-tumor effects of both chemotherapy and immune checkpoint inhibitors.

AVID BIOSERVICES HIGHLIGHTS
Avid's new manufacturing suite is fully constructed and the first internal pilot run is currently underway to verify all systems and equipment are properly functioning. Company plans to announce the launch of the new facility in the near term, allowing us to meet our internal manufacturing timelines as well as those of our third-party clients.

Contract manufacturing committed backlog reached $42 million from existing customers covering services to be completed in FY 2016 and into FY 2017.

CORPORATE HIGHLIGHTS
The European Patent Office (EPO) granted Patent Number 2,269,656, licensed to Peregrine titled "Selected Antibodies Binding to Aminophospholipids and their Use in Treatment, Such as Cancer." The patent covers bavituximab as a composition of matter and for use in therapy, such as for treating cancer including in combination with radiotherapy or chemotherapy, e.g., with docetaxel. This important patent expands upon the company's intellectual property portfolio, which now numbers more than 140 worldwide issued patents and pending applications for the bavituximab oncology program.
[ http://worldwide.espacenet.com/publicationDetails/biblio?DB=EPODOC&II=0&ND=3&FT=D&date=20141202&CC=PT&NR=2269656E&KC=E ]

FINANCIAL RESULTS
Total revenues for the first quarter of FY 2016 were $9,671,000, compared to $5,496,000 for the same quarter of the prior fiscal year. The increase was primarily 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 first quarter FY 2016 were $9,379,000, compared to $5,496,000 for the same quarter of the prior fiscal year. Peregrine expects third-party contract manufacturing revenue for FY 2016 to be between $30 and $35 million. In addition to providing biomanufacturing services to its third-party clients, Avid will continue to support the clinical and potential commercialization of bavituximab.

Total costs and expenses in the first quarter of FY 2016 were $23,425,000, compared to $18,667,000 in the first 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 and increases in the cost of contract manufacturing associated with higher reported revenue. For the first quarter of FY 2016, research and development expenses were $13,918,000, compared to $10,201,000 for the first quarter of FY 2015. For the first quarter of FY 2016, cost of contract manufacturing was $4,608,000, compared to $3,583,000 for the first quarter of FY 2015.

Peregrine's consolidated net loss attributable to common stockholders was $15,101,000, or $0.08 per share, for the first quarter of FY 2016, compared to a net loss attributable to common stockholders of $14,157,000, or $0.08 per share, for the same prior year quarter.

Peregrine reported $59,016,000 in cash and cash equivalents as of July 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. [ 9-9-15: http://tinyurl.com/pemub47 ]

CONFERENCE CALL
Peregrine will host a conference call and webcast this afternoon, September 9, 2015, at 4:30 PM EDT (1:30 PM PDT). To listen to the conference call, please dial [phone] or [phone] 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 second-line 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
THREE MONTHS ENDED
July 31, 2015 July 31, 2014
Unaudited Unaudited
REVENUES:
Contract manufacturing revenue $ 9,379,000 $ 5,496,000
License revenue 292,000 -
Total revenues 9,671,000 5,496,000

COSTS AND EXPENSES:
Cost of contract manufacturing 4,608,000 3,583,000
Research and development 13,918,000 10,201,000
Selling, general and administrative 4,899,000 4,883,000

Total costs and expenses 23,425,000 18,667,000

LOSS FROM OPERATIONS (13,754,000 ) (13,171,000 )

Interest and other income 31,000 42,000

NET LOSS $ (13,723,000 ) $ (13,129,000 )

COMPREHENSIVE LOSS $ (13,723,000 ) $ (13,129,000 )

Series E preferred stock accumulated dividends (1,378,000 ) (1,028,000 )

NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS $ (15,101,000 ) $ (14,157,000 )

WEIGHTED AVERAGE COMMON SHARES OUTSTANDING
Basic and diluted 197,317,374 179,118,255

BASIC AND DILUTED LOSS PER COMMON SHARE $ (0.08 ) $ (0.08 )

PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
JULY 31,
2015 APRIL 30,
2015
Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 59,016,000 $ 68,001,000
Trade and other receivables, net 1,805,000 3,813,000
Inventories 10,457,000 7,354,000
Prepaid expenses and other current assets, net 1,052,000 1,355,000
Total current assets 72,330,000 80,523,000
Property and equipment, net 18,395,000 15,124,000
Other assets 1,307,000 1,817,000
TOTAL ASSETS $ 92,032,000 $ 97,464,000

LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 9,840,000 $ 10,385,000
Accrued clinical trial and related fees 4,106,000 3,910,000
Accrued payroll and related costs 3,094,000 4,606,000
Deferred revenue 8,291,000 6,630,000
Customer deposits 9,599,000 11,363,000
Other current liabilities 620,000 437,000
Total current liabilities 35,550,000 37,331,000
Deferred rent, less current portion 1,036,000 1,098,000
Commitments and contingencies

STOCKHOLDERS' EQUITY:
Preferred stock - $0.001 par value; authorized 5,000,000 shares; issued and outstanding - 1,574,764 and 1,574,764, respectively 2,000 2,000
Common stock-$0.001 par value; authorized 325,000,000 shares; issued and outstanding - 200,983,948 and 193,346,627, respectively 201,000 193,000
Additional paid-in capital 522,590,000 512,464,000
Accumulated deficit (467,347,000 ) (453,624,000 )
Total stockholders' equity 55,446,000 59,035,000
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 92,032,000 $ 97,464,000

• Jay Carlson Peregrine Pharmaceuticals, Inc. 800-987-8256 [e-mail]
• Stephanie Diaz (Investors) Vida Strategic Partners 415-675-7401 [e-mail]
• Tim Brons (Media) Vida Strategic Partners 415-675-7402 [e-mail]
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[ From 10-Q header: “As of Sept 4, 2015, there were 202,124,031 shares outstanding.”

7-31-15 10-Q/pg.17/OTHER LEGAL MATTERS – CMS SETTLEMENT EXECUTED 9-8-13:
“On 9-24-12, we filed a lawsuit, captioned Peregrine Pharmaceuticals v. Clinical Supplies Management (CSM), Case# 8:12-cv-01608, against CSM, in the U.S. District Court for the Central District of California. In 2010, we had contracted with CSM as our 3rd-party vendor responsible for distribution of the blinded investigational product used in our bavituximab Phase IIb 2nd-line NSCLC trial. As part of the routine collection of data in advance of an end-of-Phase II meeting with regulatory authorities, we discovered major discrepancies between some patient sample test results and patient treatment code assignments. Consequently, we filed this lawsuit against CSM alleging, among other causes of action, breach of contract, negligence, negligence per se, constructive fraud and negligent misrepresentation arising from CSM’s performance of its contracted services. We are seeking monetary damages. On 6-5-14, CSM filed with the court a Notice of Motion and Motion for Partial Summary Judgment seeking partial summary judgment on our claims for damages on the grounds that the limitation of liability clauses contained in our master services agreement with CSM are valid and enforceable. Our opposition to CSM’s motion was filed with the court on 6-23-14, and the hearing on the motion was held on 7-28-14. On 7-30-14, the court issued its order holding that the limitation of liability clause did not apply to our claims for active negligence, negligent misrepresentation and constructive fraud, but did apply to our causes of action for breach of contract, passive negligence and negligence per se. On 3-27-15, CSM filed with the court a Notice of Motion and Motion for Partial Summary Judgment seeking partial summary judgment on our claims for damages on the grounds that the causes of action for negligence, negligence per se, negligent misrepresentation, and constructive fraud are barred by the economic loss doctrine, as well as that the causes of action for negligent misrepresentation and constructive fraud cannot be established as a matter of law. Our opposition to CSM’s motion was filed with the court on 4-13-15 and CSM’s reply to our motion was filed on 4-20-15. On 6-22-15, the court issued its order granting CSM’s Motion for Partial Summary Judgment. On 9-8-15, we and CSM entered into a confidential settlement and release agreement to resolve all claims related to the complaint we filed on 9-24-12 against CSM. Pursuant to the terms of the Settlement Agreement, (i) all claims asserted in the litigation by us will be dismissed with prejudice, (ii) each of the parties to the litigation will receive a full release of all claims, of any nature whatsoever, whether known or unknown, and (iii) CSM will pay to us the sum of $600,000 within 30 days. We will record the settlement amount when payment is received.”

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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 7-31-15 iss. 9-9-15 http://tinyurl.com/pemub47 PR: http://tinyurl.com/ph22vdn (Cash 7-31-15=$59.0mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
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= = = = = = = = = = = = = = = = = = = = = = = = = = = =
Updated PPHM REVS-BY-QTR TABLE, now thru FY16/Q1 (q/e 7-31-15), per the 7-31-15 10-Q (http://tinyurl.com/pemub47 ) issued 9-9-15.
• Total Revs since May’06: ($138.6mm/Avid + $24.1mm/Govt + $2.4mm/Lic.) = $165.2mm
• Deferred-Revs at 7-31-15, going fwd into FY’16/Q2 (q/e 10-31-15), total $8.3mm, UP from the $6.6mm of Deferred-Revs at 4-30-15 that drove into FY’16/Q1.
• Avid’s Gross-Profit over last 3 qtrs: $12.5mm on revs of $24.4mm (GP% = 49%)
• Recall, Avid Rev$ 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% 
 *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 
 Totals:        138591 24149 2416 165156 <=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 
  
 = = = = = = = = 
 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.2x) 
  
 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)

= = = = = = = = = = = =
“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 10-K's: http://tinyurl.com/p58jcbw & http://tinyurl.com/mhva3k3 ==> ((((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
= = = = = = = = = = 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."

= = = = = = = = = = = = = = = = = =
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