Friday, March 13, 2015 5:24:31 PM
3-12-15 Qtly CC-Transcript, PR(Fins/Devs Q3FY15/qe1-31-15), updated Avid Revenues History Table By Quarter…
=> Total Revs May06-Jan15: $119.9mm/Avid + $24.1mm/Govt + $2.1mm/Lic. = $146.2mm
This large post has 3 sections:
I. 3-12-15 Q3/FY15 Qtly. Earnings Conf. Call TRANSCRIPT (q/e 1-31-15)
II. 3-12-15 PPHM Press Release: Q3/FY15 Earnings & Developments
III. Updated Table of Avid Revenues By Quarter (May’06-Current)
…Recall: Peregrine’s FY runs May-Apr, so FY’15 = May’14-Apr’15.
((( Orig. transcript from SeekingAlpha.com [http://tinyurl.com/msyh4nn ], with numerous corrections made. )))
Link to webcast replay:
http://ir.peregrineinc.com/events.cfm => http://edge.media-server.com/m/p/egrx5wb7
FULL TRANSCRIPT…
3-12-2015 Q3 FY’15 Earnings Conf. Call (q/e 1-31-15)
WELCOME & FWD-LOOKING STATEMENTS: Chris Keenan (IR) http://www.peregrineinc.com
Speakers: Steve King, Robert Garnick, Joe Shan, Jeff Hutchins, Paul Lytle; Q&A session.
CEO STEVE KING – OPENING COMMENTS:
Thanks to all of you who are participating in this afternoon’s call. This is an exciting for the company on many fronts. Our lead clinical program, bavituximab, represents the most clinically advanced agents that target the immunosuppressive PS signaling pathway, and we are driven to bring this product to the market and believe it has the potential to help change the way cancer patients are treated. Bavi is in a unique position as a Phase III immuno-oncology agent that has shown great potential in combination with both current standard cancer treatments, such as chemotherapy, as well as emerging immuno-oncology agents such as those targeting PD-1 & PDL-1. Leading the way to bring Bavi to the market is our Phase III clinical trial evaluating Bavi with the chemotherapy agent docetaxel in 2nd-Line NSCLC. We continue to make great progress in this trial and are on track to complete enrollment in the study by year-end. I’ve had the opportunity to visit with investigators in the SUNRISE trial, and I continue to see enthusiasm from the sites as well as a very positive reaction to the recent immuno-oncology combination and translational clinical data coming from the rest of the bavituximab program. After completing enrollment in the SUNRISE trial, our focus is to enter into new clinical collaborations, supported by all the recent immuno-oncology preclinical & translational clinical data we have been generating. This will allow us to further explore clinical combinations of bavituximab with approved & developmental agents targeting PD-1 & PDL-1 in multiple tumor indications. We expect these efforts to be quite visible over the coming months as the planning that is well underway comes to fruition.
On top of all the exciting clinical & preclinical developments, we have continued to see remarkable revenue performance from our mfg. subsidiary, Avid Bioservices. We are raising revenue projections for the curr. FY’15 [fye 4-30-15] and bringing on new capacity that will help spur future growth by the middle of this year. This capacity will allow us to continue meeting the growing needs of our existing clients, while simultaneously allowing us to be ready for Bavi commercialization. This business is its strongest position ever as we head through the rest of FY’15 and is in a great position for a very strong FY’16.
We expect over the next few months to have the opportunity to further update you on scientific & clinical data at high profile conferences, to be able to update you on the emergence of clinical collaborations to further explore the potential of bavituximab in combination with other IO agents, and to bring online the addl. capacity of Bavi that will help grow the business. With that I’ll now turn the call over to Joe to discuss clinical development activities.
JOE SHAN (VP/Clin.&Reg. Affairs) – CLINICAL TRIALS:
As Steve just clearly outlined for you, while we remain focused on advancing bavituximab toward market approval, we’re simultaneously laying the groundwork for expanding potential use beyond NSCLC. SUNRISE, our Phase III NSCLC trial is progressing according to plan. With more than 150 clinical centers spanning 14 countries now open for enrollment, our focus is fully transitioned from the start-up to the enrollment phase, and we remain on-track to complete patient enrollment by the end of this CY. We’re also pleased with the progress made to date and encouraged by the positive feedback we have heard directly from investigators, who recognize the potential immuno-modulating mechanism of bavituximab and appreciate its safety profile to date. As a reminder, SUNRISE is designed as a Phase III registration trial and has 2 planned interim analyses [ http://www.clinicaltrials.gov/ct2/show/NCT01999673 ]. The 1st is purely to assess safety, and the 2nd will assess both safety & efficacy. As the interim analyses are triggered and a certain number of trial events are reached, in this case deaths, we cannot at this point guide to when these might occur. To protect the integrity of this double-blind trial, an Indep. Data Safety Monitoring Committee (IDMC) has been established to evaluate the data on an ongoing basis and make recommendations to Peregrine as to when the trial should be un-blinded.
In addition to this most advanced clinical trial, our clinical pipeline is supplemented by trials all designed to expand the therapeutic potential of our novel immunotherapy, bavituximab. Today we announced that final data from a Phase I IST which evaluated bavituximab in combination with paclitaxel in patients with HER2-negative metastatic Breast Cancer has been accepted for publication [Dr. Alison Stopeck] in the peer-reviewed journal Cancer Medicine and will be available online in the coming weeks. The positive data from this trial along with data from 2 prior clinical trials in advanced breast cancer makes this an exciting opportunity for the company and we continue to evaluate opportunities to advance the clinical development of bavituximab in this indication.
Also during the quarter, we announced data [1-16-15 ASCO Gastro-Symposium: http://tinyurl.com/m9uz9moshow ]from the Phase II IST evaluating bavituximab in combination with sorafenib in patients with advanced Liver Cancer, which was conducted by Dr. Adam Yopp, Assistant Professor of Surgery at the UTSW-MC/Dallas. Data demonstrated that the combination of bavituximab & sorafenib resulted in an improved time-to-progression of 6.7mos. and the disease specific survival of 8.7mos. Importantly, the combination of bavituximab & sorafenib was well tolerated in patients with advanced HCC, with no indications of auto-immune adverse events which have been seen with other check-point immunotherapies. This trial is also the subject of an oral presentation by Dr. Yopp at the Society of Surgical Oncology (SSO) at the Annual Cancer Symposium towards the end of this month [March 25-28 2015 http://tinyurl.com/q667hua ]. Also recall that translational data from 6 patients in this study were presented last November at the Society of Immunotherapy of Cancer Annual Meeting [11-8-14 SITC'14: http://tinyurl.com/pchzr6h ]. These data were generative through Dr. Dmitry Gabrilovich, a member of our Scientific Advisory Board and program leader of translational tumor immunology at the Wistar Institute. These data demonstrated an increase in cytotoxic T lymphocytes in the tumor following just one cycle of treatment with bavituximab & sorafenib. These results from treated patients are consistent with that which has been shown previously with PS targeting antibodies and multiple preclinical cancer models, specifically that bavituximab can block immunosuppression within the tumor microenvironment and induce an anti-tumor immune response. Taking together, we along with Dr. Yopp, believe that further evaluation is warranted in a larger randomized trial as resources permit.
Finally, over the past year, we’ve also invested in developing new assays that we are incorporating into trials to assess immune changes within the tumor microenvironment and characterize changes in numbers & types of immune cells. Today we announced that 3 posters have been accepted for presentation at the upcoming AACR Annual Meeting in April, and one of these posters will discuss data generated using a proprietary ex vivo system using patient tumors which was developed by the lab of Dr. Scott Antonia, another member of our SAB and the Thoracic Oncology Dept Chair and the immunology program leader at the H. Lee Moffitt Cancer Center in Florida. We believe that these activities & accomplishments over the past year further build on our foundation for development of bavituximab in combination with chemotherapies as well as with immune-checkpoint inhibitors. Meanwhile we continue to expand our growing network of thought leaders as well as potential clinical collaborators with the goal of spreading the word about our novel PS targeting-based immunotherapy platform and plan to advance the most promising combinations into the clinic as opportunities & resources permit.
JEFF HUTCHINS (VP/Preclinical Research):
As Steve mentioned, as part of our immuno-oncology dev. program, we have continued to deliver snapshots aimed at elucidating & highlighting a broad picture of bavituximab in multiple preclinical indications, with the ultimate goal of uncovering the most effective immune activating combinations. When we initiated this program in June 2013, we assembled a detailed plan designed to guide clinical dev. decision making through a series of preclinical studies to lead into translational trials in patients. These steps are absolutely critical when building a foundation for future clinical trials. I am proud of what Peregrine and our collaborators have accomplished in examining both the preclinical PS science & targeting platform by looking at multiple combinations, thereby discovering the most robust immune-oncology combination, with us seeing today now how bavituximab potentially plays a role in breaking resistance to anti-PD1 monotherapy.
Building on our strategy to disseminate our findings within the scientific & clinical medical communities, we recently presented data at the 2014 San Antonio Breast Cancer Symposium (SABCS) [12-12-14: http://tinyurl.com/p5ng6vs ] showing that the single-agent pre-clin. equivalent to bavituximab demonstrated statistically significant tumor growth inhibition as well as statistically significant increases in the % of CD4 & CD8 tumor infiltrating lymphocytes and decreases in tumor associated myeloid-derived suppressor cells (MDSC’s), all of which are key indicators of immune activation in breast tumor models when compared to a control antibody. These data confirm that the mechanism of action of bavituximab functions independent of PD-1 checkpoint blockade, therefore further highlighting our opportunity for additive or synergistic effects with IO combination therapy. As well, as the Keystone Immunology Meeting, which brought together leading scientists across multiple disciplines, we presented data showing that PS targeting antibodies, when combined with an anti PD-1 antibody, displayed statistically significant improvements in the number of tumor fighting immune cells, their activation signals associated with these cells, and the immune activated in cytokines in models of Melanoma compared to an anti PD-1 antibody alone. In addition, we saw that the cells that suppress the immune system’s ability to recognize the tumor such as MDSC’s were reduced by more than 40% in combination with the PS targeting antibodies versus anti PD-1 antibody alone. I hope that what you can see from our very successful IO dev. program, is that our results are not only positive but very consistent across multiple tumor types. These data demonstrate that the combination of a PS targeting antibody and the checkpoint inhibitor achieve statistically significant tumor growth suppression as well as significantly increased levels of immune cell expansion & activation. As Joe mentioned in his remarks, similar immune activation events were observed in HCC [Liver] patients, thus painting a consistent translational picture from preclinical-to-clinical as to the breadth of bavituximab’s ability as a combination therapy. I can tell you that data from these studies & clinical translational data from trials are being well received and, as such, we plan to continue to actively engage members of the scientific & medical communities with the goal of highlighting this potential of bavituximab throughout the coming years.
Looking to next month, 2 preclinical posters have been accepted for presentation at the 2015 AACR Annual Meeting focusing further on defining the deep impact of PS targeting agents in combination with immune checkpoint inhibitors on stimulating & sustaining T-Cell activation. It is our strong belief that these data, along with the data that we have discussed with you over the past several months, support bavituximab as a potential treatment capable of converting these non-responding anti-PD-1 therapy patients into clinical responders.
CFO Paul Lytle:
Turning to our financials, it’s important to note that we continue to closely manage our operations in line with our cap position, while balancing our various sources of capital. And one important source of capital is derived from our contract mfg. business, Avid Bioservices, which generated $5.7mm in revenue this qtr and $17.4mm for the current 9mo. period. This represents a 46% increase in revenue over the same prior year qtr, and a 10% increase over the same 9mo. period. As we look to the future, I would also like to emphasize that we have a strong backlog for future services in the amount of $29mm as of 1-31-15. This current backlog covers services to be completed during the remainder of FY’15 and into FY’16, and based on our fiscal YTD revenue and our anticipated completion of near-term projects under this backlog, we are raising our contract mfg. revenue guidance from $19-23mm to $23-25mm for the full FY’15.
In addition to a strong revenue qtr, last December we shared with you strategic plans to expand our mfg. capacity to help support the revenue growth of Avid as well as creating sufficient mfg. capacity for the potential commercial launch of bavituximab. Growing this revenue generating business is very important to us, as it reduces the amount of capital & funding we would need to raise by other means. We have made significant progress this qtr in constructing this new mfg. clean-room, and we remain on track to commence manufacturing in this new facility during mid-2015.
Now turning to expenses, we saw an expected increase in R&D spending this qtr to $11.3mm, as we continue to invest in the SUNRISE space retrial. This resulted in an increase in our net loss to ~$13mm this qtr, with a corresponding increase in our net cash burn from operations to $11.1mm, representing our reported net loss minus non-cash expenses. In conclusion, let me say that our financial goals are centered on maintaining a solid cash position and investing these proceeds into our novel immuno-oncology program, led by bavituximab, and our revenue generating mfg. business. We will continue to closely manage our operations in line with our cap position while balancing our various sources of capital. We look forward to updating you on our progress.
Q&A: [20:10 mark]
1. Joe Pantginis – Roth Capital Partners: [ http://www.roth.com & https://roth2.bluematrix.com/docs/pdf/BLUE.pdf ]
JP: ”Logistical question re: SUNRISE - I know you don’t give specific numbers, but do you feel that enrollment rates have been performing as expected?”
Joe Shan: Yes, I think things are going pretty much according to plans.
JP: And then, more towards the broader lung cancer indication - last Friday, Dr. Richard Pazdur [FDA Center for Drug Eval. & Res. – 3-4-15: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436534.htm ] made some comments regarding the approval of Opdivo, that docetaxel really shouldn’t necessarily be the std. anymore or a comparator in clinical studies. Is that going to have any potential impact on your ability to enroll patients into SUNRISE?”
Steve King: Yes, we did get some questions on the comments that he made. There are few things to keep in mind. One is that he was specifically referring to Squamous NSCLC - in fact, those patients are actually excluded from our study, so, we’re in Non-Squamous NSCLC. So, we don’t expect that that will have any overriding impact on enrollment in our study whatsoever. In the broader scheme of things, the question is, does this somehow affect our trial design or in some way impact our overall program? We’re very confident that, and the way we’re going about things, is to focus on the things that we can control, #1. Not that nothing else is going to happen in the marketplace, because you never know, but basically this was the reason we had an End-of-Ph2-meeting with the FDA. We got clearly their buy-off on the trial design which included the comparator arm. So, we’re very confident from our standpoint that we’re on track, and if we have statistically significant positive results in our study, that we should be in a great position for approval.
Rob Garnick: I totally agree, I know Dr. Pazdur pretty well. I’ve worked with him in the past, and I think his comments on the Squamous NSCLC trial with Opdivo are right on. However, as Steve said, we are in the Non-Squamous population, which is a totally different disease. Our agreements with FDA on the Phase III trial design are something that typically FDA is not going to go back on and make changes and disagree with the end-point and trial design. So I think we’re in a very strong position that should the trial be positive, as we would expect, that we will be able to obtain a good approval, relatively rapid because approval for the product because we do have the fast-track designation. So, I’m not worried about that and I also agree that it will have absolutely no effect on the accrual of patients in the trial itself. I do think that with the really great results that have been reported for Opdivo, it makes me particularly interested in combination trails with bavituximab because one of the real advantages of bavituximab is that it has an extremely good safety profile, which is actually highly unusual both in immuno-oncology drugs as well as in chemotherapy drugs in general. So, the ability to combine bavituximab with drugs like, Opdivo, and I’m sure Joe has talked about addl. trials that he’s thinking about. I’m sure in the future we’re going to see these types of combination trials come to fruition, and this will lead to label expansions and one of other very positive things for the development of bavituximab as an oncology agent.
JP: That’s very helpful Rob. I guess, even by the time SUNRISE reads out, you will have already generated more data both clinically & pre-clinically to talk to the potential potentiation of the combination and that’s something we’re looking forward to. Thanks for the added color.
Steve King: Think that’s exactly what Jeff was talking about earlier and Joe has been talking about, this is an exciting opportunity to be able to combine with Opdivo and the other PD-1, PDL-1 inhibitors that are out there. And I think that’s a grand opportunity because, while these are great results, not everyone is getting cured, and what’s needed is still to drive more patients toward being able to respond to these great new immuno-oncology drugs. Clearly we’ve shown in pre-clinical studies and now some translational data that bavituximab has that potential. So, it’s just another exciting opportunity and we look forward to addressing it.
2. Thomas Yip (MLV & Co.): http://www.mlvco.com
TY: ” I see that Avid’s revenues grew by $1.8mm this qtr vs. LY, that’s pretty impressive. With the backlog of $29mm, how do you see the expanded capability of the new plan affect the amount of that backlog?
Steve King: The backlog of the business is at this point is strictly based on the current facility. What we’re doing is adding on the ability to really grow that significantly. So, it’s really two-fold. #1, it allows us to continue to grow the base business to meet the growing demands of our existing clients as well as new clients that are coming in, and at the same time be ready for bavituximab’s commercial launch. I think that it’s a great opportunity; I really view this as a great growth business. Clearly the revenue growth this year we’re expecting to be very nice and setting the stage for really nice FY’16 [May’15-Apr’16] coming up. So, it’s great to have this new addition coming online just at a time when we maybe can take the most advantage of it.
TY: ”You mentioned preparing for bavituximab U.S. launch. Will this new capacity be able to cover the anticipated demand for NSCLC in the U.S.?
Steve King: That’s exactly what the planning was in building up the facility, to be able to meet the commercial launch. Now, if we’re successful with bavituximab in as many indications as we think we can be then, yes, we may need another facility. But at that point that will probably easier to address. We’ve definitely built it really with bavituximab commercial launch and commercial supply in mind. And I think it’s one of the other interesting things about the developments with Opdivo, for instance, in that they got accelerated approval , based on some great clinical data, but they were in a position to take advantage of that because they already had the mfg. in place. This is one of the beauties of the model we have here, which is that since we do have this mfg. capacity in hand, we do have the ability, should we be fortunate enough to have some early good results come from one of the interim looks in the study, to potentially take advantage of that. That’s the other thing that’s great from having this new facility online is it allows us to be able to meet that. Rob, do you want to add anything to that?
Rob Garnick: That’s a really good point. A lot of companies have actually stumbled in the past because they had a drug that worked but they weren’t able to produce the satisfactory commercial supply. But we certainly have size & designs planned in order to produce both the launch capability and actually out a number of years in the expansion of the drug into the marketplace. So, I agree with Steve, I think we should be so lucky as to have the problem of having to build another plant - that would be out good doing.
TY: Where will the cost of this plan show up in the P&L and over how long a period of time?
Paul Lytle: The current asset that we’re building is currently tracked under construction & progress on our balance sheet. So, the actual cost will be stored there and then we’ll depreciate this asset over a number of years and that will show up in cost as we mfg. for customers.
3. George Zavoico – Jones Trading
GZ: ” Avid followup - did ever you mention how much the expansion is going to cost? And if you have or if you can, how long before you get the return on that investment with the increased business through the backlog?
Paul Lytle: We haven’t said exactly what the total facility is going to cost us, just from a competition standpoint. I think as soon as we build it we’re going to have kind of a launch party for the actual asset; it will show up in our balance sheet when it is officially launched. In terms of capitalizing on this asset, our goal is basically to put as many customers into this facility as we can. Initially, bavituximab will just need a handful of mfg. runs to prepare for commercialization. And then, the remaining amount of capacity is available for3rd-party customers and depending on how we execute on our future potential business, I think the return on investment should be fairly quick.
GZ: ”How much Avid business is for the largest customer and what % of the capacity is now by 1 or 2 or 3 of your customers? How dependent are you on 1 or 2 or 3 customers, in other words?”
Paul Lytle: If you look at on the segment reporting on our 10-Q, it breaks out the customers. I believe Halozyme Therapeutics represents ~80% of our revenue that’s reported for the past qtr.
GZ: With regard to SUNRISE, have you disclosed how many events have to happen for the interim analysis, the 1st one and the 2nd one? And have those number of events changed? And how much effect does that have on the powering?
Joe Shan: We’ve just given a broad guidance; it’s pretty standard. The 1st interim is at 33% of events, it’s a futility look, mainly you look at safety; the 2nd one is at 50% events.
GZ: ”50%?”
Joe Shan: Yes. So that’s not changed. And as I mentioned in my prepared remarks, we’re not monitoring that and watching that daily, that’s the job of the IDMC.
Steve King: We obviously can’t really control when we’ll make it to those events; they’re driven by patterns of patient enrollments and by patient outcomes, so it’s even more unpredictable to guess when those might be. But it’s a pretty standard sign and any alpha hit was taken into account in the overall trial design.
GZ: ”Finally, a little more general to strategic questions. It’s becoming pretty clear I think that Opdivo & PD-1, that these checkpoint inhibitors have already arrived on the market, have tremendous efficacy and a derivative response for a relatively small proportion, 20% to 30%, of patients. And, that combining checkpoint inhibitors such as bavituximab with either of those could potentially greatly improve the efficacy without really compromising the safety. From a strategic point of view, if you’re Merck or Bristol-Myers, would you want to lock up the use of a 2nd immune checkpoint inhibitor like Bavi with just one of those to capture more of the market, or expand the market, for particular indication or until there are indications - is that a viable strategy for some of the big pharmaceutical companies and does that play into your discussions with some of the partners that you’re talking to?
Steve King: Clearly, combinations are the name of the game now in the immuno-oncology space. We believe that based on our safety profile and what we’ve seen so far in the tumor microenvironment changes, as well as the actual data coming out of our studies, that we’re potentially a really great combination partner with any other PD-1, PDL-1 players. Absolutely, these kinds of things can come into the discussions. From our standpoint, we would like to be able to look at as broad a collection of those types of agents as we can, because while in theory they all behave the same, you never know what you’re going to see clinically. At this point, there is no reason to believe PD-1 or PDL-1 is going to have a distinct advantage. So, that comes into the discussion. I wouldn’t rule out that we may have multiple collaborations ongoing with different types of agents within the PD-1, PDL-1 space for that reason from our standpoint. So, we want to explore those. But at some point, if we start to show efficacy and we can add to the value of the platform, I think the beauty of combining bavituximab is that effectively we’re not diminishing the size of the PD-1 market, in fact we’re only enhancing it by allowing potentially more patients to respond that otherwise might not respond. So I think that’s absolutely very attractive and obviously the ideal from a pharmaceutical development standpoint.
GZ: ”In order to maintain your independence perhaps as long as possible, because obviously Opdivo and Keytruda are going to be pretty expensive drugs. Could various cooperative groups or potentially different sponsors move into these combinations to maintain your independence and perhaps increase the value when you actually do get to the point of negotiating an agreement?
Steve King: There are lots of possibilities. One is direct collaborations with the pharmaceutical companies that have the drugs in indications where they might not be approved yet. Of course, once the drugs are on the market and become part of the SOC, such as is happening in Melanoma and now coming into Squamous NSCLC, effectively those studies could be run even independently because of the fact that they would be covered by insurance. Then the 3rd of course is the cooperative groups or other groups that may have access to the drugs or a supply of them that can run their own studies. So, what I can say is we’re actively looking at all of those different possibilities and we want to put together the best program that will allow us to answer the questions we’re most interested in.
4. Roy Buchanan for Charles Duncan – Piper Jaffray [http://www.piperjaffray.com – 3-5-13 Initiates PPHM: http://tinyurl.com/bxhntk3 ]
RB: ”Re: SUNRISE, are you planning any presentations this year around the interims or just conduct of the trial or enrollment or anything?
Steve King: I think other than maybe a trial in progress type of presentation at ASCO, the interim data looks as Joe described them, but they’re probably not worthy of their standalone presentation. We’re still blinded.
RB: ”No idea about timing on those at all?
Joe Shan: No.
RB: ”The Phase I ISTs aren’t in your control, but any thoughts on when we might see data from those?”
Steve King: We’re obviously a little bit more actually involved in, and helping to encourage the holders of those ISTs. We’re hopeful that even this year we might be able to start see some of the data coming from those studies. We had a little bit of data from one of the ISTs late last year and early this year from the Liver Cancer study - more data potentially coming from that clinical trial as we complete some of the translational pieces of the dataset and as well as we have another clinical presentation coming up at the end of March. So, I think those will see a bit more activity and then, as we start new studies, that will start the clock ticking on potentially more data coming through. In addition to those, I think as was mentioned in the presentation, we have other data coming from collaboration with Scott Antonia and his group in looking at some addl. data for bavituximab. So, there will be a heavy dose of data coming from the ISTs as well as other kind of preclinical-type activities.
MR. KING’S CLOSING COMMENTS:
I’d like to thank all of you again for participating in today’s call. We strongly believe that the path we are taking on the development front-end will add significant value to the bavituximab program by expanding potential indications & combinations, which helps ensure commercial success. Along with the continued growth of Avid, which adds value through growing 3rd-party revenues, which increases the value of the business, by helping offset the overall cash burn, and perhaps most importantly allowing us to be prepared for bavituximab’s success. Taking together, all these activities should increase shareholder value. And we look forward to that reflection in our market valuation. I thank you all again for your continued support.
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3-12-15 PR: “Peregrine Pharmaceuticals Reports Third Quarter FY 2015 Financial Results and Recent Developments”
• SUNRISE Phase III Lung Cancer Trial On Track to Complete Enrollment by Calendar Year-End
• Encouraging and Consistent Data from Immuno-Oncology Development Program Continue to Support Bavituximab's Immunostimulatory Mechanism
• Avid Bioservices Increases Revenue Guidance to $23-25 mm for Full Fiscal Year 2015 Based on Strong Demand for Services
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=901398
TUSTIN, March 12, 2015: Peregrine Pharmaceuticals, Inc. (Nasdaq:PPHM) (Nasdaq:PPHMP), a biopharmaceutical company focused on advancing bavituximab, a novel immuno-oncology agent in Phase III development, today announced financial results for the third quarter of fiscal year (FY) 2015 ended January 31, 2015. The company also provided an update on its advancing clinical pipeline and reviewed other corporate developments.
"This is an exciting time for the company on many fronts. Our lead clinical program, bavituximab is in a unique position as a Phase III immuno-oncology agent that has shown great potential in combination with both current standard cancer treatments, such as chemotherapy, as well as emerging immuno-oncology agents such as those targeting PD-1 and PD-L1. We have continued to advance the bavituximab Phase III SUNRISE trial and are on track to complete enrollment in the study by year-end," said Steven W. King, President and CEO of Peregrine. "Aside from completing enrollment in the SUNRISE trial, our clinical focus is to enter into new clinical collaborations to further explore the combination potential of bavituximab with anti-PD-1 and PD-L1 in multiple tumor indications and we expect these activities to be quite visible over the coming months as the planning that is underway now, comes to fruition. These efforts, on top of completing the Avid capacity expansion and continued revenue growth, point to many important milestones throughout remainder of 2015."
The company's mission is to develop a brand new class of immunotherapies focused on the clinical advancement of our lead drug candidate bavituximab which targets the immunosuppressive PS signaling pathway. Bavituximab has the potential to be an effective part of treatment regimens in many different tumor types and has recently shown promise in combination with other immuno-oncology compounds in multiple preclinical models of cancer. Over the past quarter, the company has made important progress in bringing this novel immunotherapy closer to the market led by the SUNRISE Phase III clinical trial.
The company continues to enroll patients in the SUNRISE (Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III Lung Cancer Study) trial. SUNRISE is a Phase III, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety, tolerability and efficacy of bavituximab as a second-line treatment in patients with non-squamous, non-small cell lung cancer (NSCLC). The trial is evaluating bavituximab plus the standard chemotherapy docetaxel versus docetaxel plus placebo in approximately 600 patients at clinical sites worldwide. Patients with Stage IIIb/IV non-squamous NSCLC who have progressed after standard front-line treatment are eligible for enrollment. The primary endpoint of the trial is overall survival. The company anticipates completing patient enrollment in the SUNRISE trial by the end of calendar year 2015. For additional information about the SUNRISE trial, please visit http://www.sunrisetrial.com or http://ClinicalTrials.gov using the Identifier NCT01999673. [ http://www.clinicaltrials.gov/ct2/show/NCT01999673 ]
The company's commitment to exploring the full clinical potential of bavituximab in combination with chemotherapies or other immuno-oncology agents is being executed through a series of Investigator-Sponsored Trials (IST) in multiple solid tumor indications. The following represents anticipated upcoming data from ongoing or completed clinical studies as well as the status of trials that can yield data in the future:
Final data from a Phase I IST that evaluated bavituximab in combination with paclitaxel in patients with HER2-negative metastatic breast cancer has been accepted for publication [Dr. Alison Stopeck] in the peer-reviewed journal Cancer Medicine and will be published online in the coming weeks. The company is currently evaluating opportunities to advance the clinical development of bavituximab in breast cancer.
Data from a Phase II IST that evaluated bavituximab in combination with sorafenib in patients with advanced hepatocellular carcinoma (HCC), or liver cancer, presented at the 2015 Gastrointestinal Cancers Symposium Data [1-16-15 ASCO Gastro-Symposium: Ph.2 data/n=38 (Adam Yopp), ‘These clinical outcomes of TTP=6.7/DCR=58%/PFS=4mo are quite encouraging…’ http://tinyurl.com/m9uz9moshow ] that the combination of bavituximab and sorafenib is associated with an improved time to progression (TTP) of 6.7 months, a disease specific survival (DSS) of 8.7 months, a disease control rate (DCR) of 58% (22 out of 38 patients) and a 4-month progression-free survival (PFS) of 62%. Two patients (5%) achieved a partial response according to Response Evaluation Criteria In Solid Tumors (RECIST). The secondary endpoint of median overall survival (OS) was 6.2 months. The combination of bavituximab and sorafenib was well-tolerated in patients with advanced HCC with no indications of autoimmune adverse events that have been seen with other checkpoint immunotherapies. During the quarter, translational data from 6 patients from this trial were presented at the Society for Immunotherapy of Cancer's (SITC) 29th Annual Meeting and Associated Programs [11-8-14 SITC'14: http://tinyurl.com/pchzr6h ]. These data, to assess and measure changes in immune response pre- and post-treatment, show the ability of bavituximab to positively regulate an increase in tumor fighting immune cells (particularly CD8 T cells) following one cycle of treatment, thus further confirming in patients what has been shown for PS-targeting antibodies in multiple preclinical cancer models. This trial is also the subject of an oral presentation at the Society of Surgical Oncology's (SSO 2015) 68th Annual Cancer Symposium to be held March 25-28, 2015 in Houston, Texas [See: http://tinyurl.com/q667hua ].
A Phase I IST evaluating bavituximab in combination with capecitabine and radiation therapy in up to 18 patients with Stage II or III rectal adenocarcinoma is open for patient enrollment.
A Phase Ib IST evaluating bavituximab in combination with Bristol-Myers Squibb's ipilimumab (Yervoy®) in up to 24 patients with advanced melanoma is open for patient enrollment.
As part of the company's mission to discover the full potential of its immunotherapy bavituximab in clinical disease applications, the company is advancing studies through its Immuno-Oncology Development Program. This program is designed to explore the potential of combining bavituximab with other immunotherapies, experimental immuno-oncology drugs including checkpoint inhibitors, as well as vaccines.
During the quarter, data presented at the 2014 San Antonio Breast Cancer Symposium (SABCS) [12-12-14: http://tinyurl.com/p5ng6vs ] show that the monotherapy preclinical equivalent to bavituximab demonstrated statistically significant tumor growth inhibition in breast tumor models when compared to a control antibody. Data further show that this monotherapy yielded statistically significant increases in the percentage of tumor fighting T-lymphocytes and decreases in tumor inflammatory myeloid-derived suppressor cells (MDSC), all key indicators of immune activation.
Data presented recently at the Keystone Tumor Immunology meeting [2-9-15: http://tinyurl.com/q6cx4w6 ] show that the PS-targeting antibody equivalent to bavituximab combined with an anti-PD-1 antibody displayed statistically significant improvement in tumor fighting immune cells, activation signals and cytokines in a model of melanoma compared to anti-PD-1 alone. Moreover, cells that suppress the immune system from recognizing tumors, such as MDSCs, were reduced by more than 40% in the combination with the PS-targeting antibody versus anti-PD-1 alone.
Peregrine announced today the acceptance of 3 posters at the American Association for Cancer Research's (AACR) Annual Meeting to be held April 18-22, 2015 in Philadelphia, Pennsylvania. These posters include preclinical data from the company's Immuno-Oncology Development Program of PS-targeting agents in combination with immune checkpoint inhibitors in breast cancer and melanoma, as well as translational research conducted with tumor tissue from lung cancer patients.
The company is also exploring other applications for the PS-targeting platform outside of cancer therapy. These activities include:
PS-TARGETING MOLECULAR IMAGING PROGRAM
The company is exploring the potential of its experimental PS-targeting molecular imaging candidate, 124I-PGN650, in patients with various solid tumor types. This is an open-label, single-center trial with a primary goal of estimating radiation dosimetry in critical and non-critical organs and secondary objectives of tumor imaging and safety.
AVID BIOSERVICES
Avid Bioservices, Inc. is the contract manufacturing subsidiary of Peregrine. Avid provides high quality clinical and commercial manufacturing services under cGMP for the biotechnology and biopharmaceutical industries. As announced in December, Avid is in the process of expanding its manufacturing capacity with a new state-of-the-art facility. Activities supporting this expansion continue and the company remains on track to commence manufacturing in the new facility during mid-2015.
"Our Avid business had another strong quarter further supporting our decision announced in December to expand our manufacturing capacity to meet the growing needs of our manufacturing business as well as the anticipated commercial launch of bavituximab," said Paul Lytle, CFO of Peregrine. "Our current backlog for manufacturing services has increased to $29 mm and we are increasing our revenue guidance from between $19 to $23 mm to between $23 and $25 mm for the full FY 2015."
FINANCIAL RESULTS
Contract manufacturing revenue from Avid's clinical and commercial biomanufacturing services provided to its third-party customers for the third quarter FY 2015 were $5,677,000, compared to $3,885,000 for the same quarter of the prior fiscal year. In addition to providing biomanufacturing services to its third-party customers, Avid will continue to support the potential commercialization of bavituximab.
Total costs and expenses in the third quarter of FY 2015 were $18,699,000, compared to $13,628,000 in the third quarter of FY 2014. This increase was primarily attributable to the current quarter increases in research and development expenses associated with the SUNRISE Phase III trial and cost of contract manufacturing associated with higher contract manufacturing revenue, which were offset by the current quarter decrease in selling, general and administrative expenses. For the third quarter FY 2015, research and development expenses were $11,261,000, compared to $6,649,000 for the third quarter of FY 2014. For the third quarter of FY 2015, cost of contract manufacturing was $3,113,000, compared to $2,416,000 for the third quarter of FY 2014. For the third quarter of FY 2015, selling, general and administrative expenses were $4,325,000 compared to $4,563,000 for the third quarter of FY 2014.
Peregrine's consolidated net loss attributable to common stockholders was $14,027,000, or $0.08 per share, for the third quarter of FY 2015, compared to a net loss attributable to common stockholders of $9,724,000, or $0.06 per share, for the same quarter of the prior year.
Peregrine reported $55,238,000 in cash and cash equivalents as of January 31, 2015 compared to $77,490,000 at fiscal year ended April 30, 2014.
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. [ 10-Q: http://tinyurl.com/mwedt8w ]
CONFERENCE CALL
Peregrine will host a conference call and webcast this afternoon, March 12, 2015, at 4:30 PM EDT (1:30 PM PDT). 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 for the treatment and diagnosis of cancer. The company's lead immunotherapy candidate, bavituximab is in Phase III development for the treatment of second-line non-small lung cancer (the "SUNRISE trial") along with several investigator-sponsored trials evaluating other treatment combinations and additional oncology indications. The company is also advancing a molecular imaging agent, 124I-PGN650, in an exploratory clinical trial for the imaging of multiple solid tumor types. 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. Additional information about Peregrine can be found at http://www.peregrineinc.com.
Safe Harbor *snip*
Yervoy is a registered trademark of Bristol-Myers Squibb.
Contact: Christopher Keenan, Peregrine Pharmaceuticals, Inc., (800) 987-8256 - info@peregrineinc.com
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
THREE MONTHS ENDED JANUARY 31, NINE MONTHS ENDED JANUARY 31,
2015 2014 2015 2014
Unaudited Unaudited Unaudited Unaudited
REVENUES:
Contract manufacturing revenue $ 5,677,000 $ 3,885,000 $ 17,436,000 $ 15,820,000
License revenue -- -- 37,000 107,000
Total revenues 5,677,000 3,885,000 17,473,000 15,927,000
COSTS AND EXPENSES:
Cost of contract manufacturing 3,113,000 2,416,000 10,835,000 9,281,000
Research and development 11,261,000 6,649,000 31,465,000 18,910,000
Selling, general and administrative 4,325,000 4,563,000 13,503,000 12,913,000
Total costs and expenses 18,699,000 13,628,000 55,803,000 41,104,000
LOSS FROM OPERATIONS (13,022,000) (9,743,000) (38,330,000) (25,177,000)
OTHER INCOME (EXPENSE):
Interest and other income 29,000 23,000 108,000 68,000
Interest and other expense (1,000) (4,000) (1,000) (5,000)
NET LOSS $ (12,994,000) $ (9,724,000) $ (38,223,000) $ (25,114,000)
COMPREHENSIVE LOSS $ (12,994,000) $ (9,724,000) $ (38,223,000) $ (25,114,000)
Series E preferred stock accumulated dividends (1,033,000)
--
(2,577,000)
--
NET LOSS ATTRIBUTABLE TO COMMON SHAREHOLDERS $ (14,027,000) $ (9,724,000) $ (40,800,000) $ (25,114,000)
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:
Basic and Diluted 182,519,923 163,223,767 180,562,524 156,521,874
BASIC AND DILUTED LOSS PER COMMON SHARE $ (0.08) $ (0.06) $ (0.23) $ (0.16)
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
JANUARY 31, 2015 APRIL 30, 2014 Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 55,238,000 $ 77,490,000
Trade and other receivables, net 6,284,000 1,332,000
Inventories 6,148,000 5,530,000
Prepaid expenses and other current assets, net 934,000 1,419,000
Total current assets 68,604,000 85,771,000
Property and equipment, net 8,958,000 2,447,000
Other assets 1,559,000 2,327,000
TOTAL ASSETS $ 79,121,000 $ 90,545,000
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 6,814,000 $ 2,434,000
Accrued clinical trial and related fees 3,117,000 4,433,000
Accrued payroll and related costs 3,716,000 3,837,000
Deferred revenue, current portion 5,752,000 5,241,000
Customer deposits 8,311,000 5,760,000
Other current liabilities 490,000 502,000
Total current liabilities 28,200,000 22,207,000
Deferred revenue, less current portion -- 292,000
Other long-term liabilities 1,127,000 347,000
Commitments and contingencies
STOCKHOLDERS' EQUITY:
Preferred stock- $0.001 par value; authorized 5,000,000 shares; issued and outstanding - 1,180,004 and 775,000, respectively 1,000 1,000
Common stock- $0.001 par value; authorized 325,000,000 shares; outstanding - 184,244,698 and 178,871,164, respectively 184,000 179,000
Additional paid-in capital 491,098,000 470,785,000
Accumulated deficit (441,489,000) (403,266,000)
Total stockholders' equity 49,794,000 67,699,000
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 79,121,000 $ 90,545,000
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[ From 10-Q header: “As of Mar. 6, 2015, there were 188,332,872 shares of issuer’s common stock.”
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Latest 10K 4-30-14 iss. 7-14-14: http://tinyurl.com/mhva3k3 PR: http://tinyurl.com/o2e4a4g (Cash 4-30-14=$77.5mm)
Latest 10Q 1-31-15 iss. 3-12-15 http://tinyurl.com/mwedt8w PR: http://tinyurl.com/q78oxvm (Cash 1-31-15=$55.2mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
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= = = = = = = = = = = = = = = = = = = = = = = = = = = =
Updated PPHM REVS-BY-QTR TABLE, now thru FY15/Q3 (qe 1-31-15), per the 1-31-15 10-Q ( http://tinyurl.com/ksjrqge ) issued 3-12-15. Deferred-Revs at 1-31-15, going fwd into FY’15/Q4 (fy/e 4-30-15), total $5.8mm, up from the $3.6mm of Deferred-Revs at 10-31-14 that drove into FY’15/Q3.
Total Revs since May’06: ($119.9mm/Avid + $24.1mm/Govt + $2.1mm/Lic.) = $146.2mm
Avid’s Gross-Profit over last 3 qtrs: $6.6mm on revs of $17.4mm (GM% = 38%)
=> Recall, Avid Rev$ 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.”
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- - - - - - - - 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)
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“Going Concern” statement ELIMINATED from 4-30-13 10-K issued 7-11-2013…
2012: 4-30-12 10-K iss. 7-16-12 http://tinyurl.com/79o57b2
Pg.68: “As more fully described in Note 2, the Company’s recurring losses from operations and recurring negative cash flows from operating activities raise substantial doubt about its ability to continue as a going concern.”
2013 & 2014 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
= = = = = = = = = = 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."
= = = = = = = = = = = = = = = = = = http://www.peregrineinc.com
Peregrine’s Corp. Fact Sheet updated 3-12-2015:
http://www.peregrineinc.com/images/stories/pdfs/fact_sheet_march_2015.pdf Pg1:
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3-9-15: CEO Steve King’s 24min. talk at ROTH Conf. (DanaPT CA) - SLIDES http://tinyurl.com/p873grw
12-10-14 Qtly. Conf. Call (King/Shan/Hutchins/Lytle) Transcript http://tinyurl.com/kmdgq8t
...CEO S.King: “We believe Peregrine is in a unique position with an immune-oncology program already in Phase III, with what has been a positive safety profile and a target that is ideal for combining with other IO agents.”
10-16-14 Peregrine ASM: Slides(42), Audio-Replay-Link, Attendee-Reports http://tinyurl.com/oyc3e5v
9-9-14 Qtly. Conf. Call (King/Hutchins/Shan/Lytle) Transcript http://tinyurl.com/ktrfswj
...CEO S.King: “In addition to our clinical trials, many of which have also have translational data points built in to tie together pre-clin. data with the clinic, we have also continued to build momentum in our pre-clin. collaborations which now number in the dozens. We are evaluating new combinations & dosing strategies combining bavituximab with chemotherapy, radiation, and immune-oncology approaches, including those targeting CTLA-4, PD-1, as well as other downstream immune checkpoints."
7-14-14 Qtly. Conf. Call (King/Shan/Hutchins/Worsley/Lytle) Transcript http://tinyurl.com/o2e4a4g
...CEO S.King: “Partnering remains a priority with the goal being to use partnerships to continue expanding the bavituximab program, while we continue to execute the SUNRISE Phase III trial.”
3-10-14: CEO Steve King’s 22min. talk at ROTH Conf. (DanaPT CA) - SLIDES http://tinyurl.com/n65myfk
3-7-14 Qtly. Conf. Call (King/Shan/Garnick/Lytle) Transcript http://tinyurl.com/kh9cnrg
...CEO S.King: “I don't want to overuse the word ‘excitement’, but these are truly exciting times that have positioned us for success on all fronts.”
12-10-13 Qtly. Conf. Call (King/Shan/Garnick/Hutchins/Worsley/Lytle) Transcript http://tinyurl.com/mw776mk
...CEO S.King: “We believe that Peregrine is uniquely positioned among the companies developing immunotherapies… and that because of our current valuation, we represent a unique investment opportunity.
• All of Dr. Robert Garnick's public comments (thru 3-7-2014) while at Peregrine: http://tinyurl.com/obvwyuh Steve King said 6-29-11, "Rob is the ringmaster."
• 6-29-11 Minyanville article, "Peregrine Pharma's Secret Weapon [Robert Garnick]" http://tinyurl.com/9jtnan o
• Examples of Dr. Garnick's work at Genentech on Avastin (bevacizumab) approvals: http://tinyurl.com/yg7vtqa
PS-TARGETING SCIENCE: "Evolution has favored pathogenesis that resembles apoptosis."
Dr. Judah Folkman: ”This [Thorpe’s VTA research] is very promising and very elegant work... The whole goal is really 2-part, reducing the harsh side effects of cancer treatment, and reducing the chance that some cancer cells will evade treatment. That would be a big step in the next decade, and anti-vascular therapy will play a major role." (’97 & ’02 http://tinyurl.com/k5qe96g & http://tinyurl.com/n6vh9hp )
Peregrine's Bavituximab & Cotara Technologies: http://www.peregrineinc.com/technology/overview.html
Peregrine's Clinical Trials website: http://PeregrineTrials.com
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Bavituximab MOA & Clinical Data: http://www.peregrineinc.com/pipeline/bavituximab-oncology.html
...Bavi Publications: http://www.peregrineinc.com/publications/publications.html
...Bavi Posters & Presentations: http://www.peregrineinc.com/publications/posters-and-presentations.html
Bavi MOA: Video (3:34) added ~3-2014 http://vimeo.com/87116642 "Bavituximab: A Novel Immunotherapy Candidate Targeting an Upstream Immune Checkpoint to Fight Cancer"
Bavi MOA: Video (1:33) on Bavi’s Immunotherapeutic MOA added to Youtube on 3-27-14 https://www.youtube.com/watch?v=Esewl35JD8s
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
BAVI MOA 12-12-14 San Antomio Breast Cancer Symposium, Dr. Bruce Freimark, Bavi+anti-PD-1 vs. Breast Cancer http://tinyurl.com/p5ng6vs
BAVI MOA 11-2014 SITC’14: 3 posters on preclin. Bavi+aCTLA4/aPD1 combo data (Hutchins Freimark Brekken Huang etal) http://tinyurl.com/pchzr6h
BAVI MOA 8-28-14: Italy’s Dr. Federico Cappuzzo, Bavi/NSCLC profile article (DovePress OpenAccess, 7pgs) - http://tinyurl.com/n3oa7bc
BAVI MOA 8-11-14: PPHM/VP Dr. Jeff Hutchins’ presentation at ImVacS "Immunotherapies & Vaccine Summit", Boston - PR: http://tinyurl.com/lpjy3u7 ; PDF(31 Slides): http://tinyurl.com/oueldme
...MLV’s Dr. George Zavoico’s 8-27-14 report on Dr. Jeff Hutchins’ 8-11-14 ImVacS/Boston Bavi MOA presentation: http://tinyurl.com/l3tw63c
BAVI MOA 5-28-14: Dr. Rolf Brekken’s 47min CRI “Cancer Immunotherapy” webinar about Bavituximab as an Upstream/Global Immune Checkpoint Inhibitor – REPLAY: http://tinyurl.com/lxgftyx
. . .CRI=Cancer Research Institute (NYC – Supported by BMS): http://www.cancerresearch.org - Facebook: http://tinyurl.com/pbmhb2z , https://twitter.com/CancerResearch
. . .CRI launches “Answer to Cancer” (cancer immunotherapy) website http://www.theanswertocancer.org
. . .8-12-14: CRI adds Youtube links to the 5-28-14 CRI Immunotherapy webinar, incl. Dr. Brekken's talk "about Bavi and how it works against lung, liver, and other kinds of cancers" http://tinyurl.com/ps5h6h8
BAVI MOA 3-25-14: Dr. Rolf Brekken’s 40min talk at NYAS Lung Cancer Symposium http://tinyurl.com/lq9stnk (45 Slides)
. . .Dr.Brekken’s talk: “Antibody-mediated Inhibition of PS - A Novel Strategy for Immune Checkpoint Blockade” (the 5 speakers: Jessica Donington, Roy Herbst, Balazs Halmos, Suresh Ramalingam, Rolf Brekken)
12-10-13: With recent scientific insights highlighting bavi’s immunostimulatory moa, these additions to PPHM’s SAB: Dimitry Gabrilovich, Scott Antonia, David Carbone**, Hakan Mellstedt http://tinyurl.com/mw776mk
......**A/o 9-2014, Dr. David Carbone (PPHM SAB/KOL) is President-Elect of IASLC https://www.iaslc.org/about-us/board
BAVI MOA: 12-2013 Bavi’s Immunotherapeutic MOA overviewed by UTSW’s Brekken/Huang in Pan European Networks Jrnl. http://tinyurl.com/lnb46pq
BAVI MOA 11-9-13: Annual SITC (WashDC) – 2 posters about Bavi’s Immunostimulatory MOA http://tinyurl.com/mjaweu5
...“We are actively working towards initiating a clinical trial in the coming months to further investigate the potential synergistic effects of bavituximab and an approved [anti-CTLA-4] immunotherapy in patients with Melanoma."
10-28-13 IASLC/Sydney: “Immune Checkpoints in the Tumor Environment: Novel Targets & the Clinical Promise of Combined Immunotherapies” http://tinyurl.com/mjaweu5
…Symposium speakers: Scott J. Antonia/MD-PhD(H.Lee Moffitt CC), Dmitry I. Gabrilovich/MD-PhD(Wistar Inst), Rolf A. Brekken/PhD(UTSW), David E. Gerber/MD(UTSW)
BAVI MOA: 8-19-13 Data Supporting Bavituximab’s Immunotherapy MOA Published in “Cancer Immunology Research” (AACR) - http://tinyurl.com/mhjftka (PDF)
…“PS-Targeting Antibody Induces M1 Macrophage Polarization & Promotes Myeloid-Derived Suppressor Cell Differentiation” (Thorpe etal)
BAVI MOA: 8-13-13 PPHM/VP Dr. Jeff Hutchins’ Presentation on the Downstream Immunostimulatory Effects/Moa of PS-targeting antibodies (like Bavi) at CHI’s “Immunotherapies Congress”/Boston http://tinyurl.com/m6h2tvt
BAVI MOA: 10-12-12 NMB article on how Bavi "Induces Innate & Specific Anti-tumor Responses" http://tinyurl.com/cw9odb8
BAVI MOA: 5-1-12 Dr. Phil Thorpe's 46min talk at NYAS PS-Targeting Symposium http://tinyurl.com/9792gl5
. . .Symposium title: "Phosphatidylserine (PS) Asymmetry - Therapeutic Apps. in Cancer & Infectious Disease Symposium"
. . .Replays of 5 speakers: Alan Schroit, Chris Reutlingsperger, David Ucker, Ari Helenius, Philip Thorpe
BAVI MOA: 5-26-11 Dr.Thorpe's keynoter at Recombinant-Mabs/Barcelona http://tinyurl.com/3klpodc & http://tinyurl.com/3m33h33
=> Total Revs May06-Jan15: $119.9mm/Avid + $24.1mm/Govt + $2.1mm/Lic. = $146.2mm
This large post has 3 sections:
I. 3-12-15 Q3/FY15 Qtly. Earnings Conf. Call TRANSCRIPT (q/e 1-31-15)
II. 3-12-15 PPHM Press Release: Q3/FY15 Earnings & Developments
III. Updated Table of Avid Revenues By Quarter (May’06-Current)
…Recall: Peregrine’s FY runs May-Apr, so FY’15 = May’14-Apr’15.
((( Orig. transcript from SeekingAlpha.com [http://tinyurl.com/msyh4nn ], with numerous corrections made. )))
Link to webcast replay:
http://ir.peregrineinc.com/events.cfm => http://edge.media-server.com/m/p/egrx5wb7
FULL TRANSCRIPT…
3-12-2015 Q3 FY’15 Earnings Conf. Call (q/e 1-31-15)
WELCOME & FWD-LOOKING STATEMENTS: Chris Keenan (IR) http://www.peregrineinc.com
Speakers: Steve King, Robert Garnick, Joe Shan, Jeff Hutchins, Paul Lytle; Q&A session.
CEO STEVE KING – OPENING COMMENTS:
Thanks to all of you who are participating in this afternoon’s call. This is an exciting for the company on many fronts. Our lead clinical program, bavituximab, represents the most clinically advanced agents that target the immunosuppressive PS signaling pathway, and we are driven to bring this product to the market and believe it has the potential to help change the way cancer patients are treated. Bavi is in a unique position as a Phase III immuno-oncology agent that has shown great potential in combination with both current standard cancer treatments, such as chemotherapy, as well as emerging immuno-oncology agents such as those targeting PD-1 & PDL-1. Leading the way to bring Bavi to the market is our Phase III clinical trial evaluating Bavi with the chemotherapy agent docetaxel in 2nd-Line NSCLC. We continue to make great progress in this trial and are on track to complete enrollment in the study by year-end. I’ve had the opportunity to visit with investigators in the SUNRISE trial, and I continue to see enthusiasm from the sites as well as a very positive reaction to the recent immuno-oncology combination and translational clinical data coming from the rest of the bavituximab program. After completing enrollment in the SUNRISE trial, our focus is to enter into new clinical collaborations, supported by all the recent immuno-oncology preclinical & translational clinical data we have been generating. This will allow us to further explore clinical combinations of bavituximab with approved & developmental agents targeting PD-1 & PDL-1 in multiple tumor indications. We expect these efforts to be quite visible over the coming months as the planning that is well underway comes to fruition.
On top of all the exciting clinical & preclinical developments, we have continued to see remarkable revenue performance from our mfg. subsidiary, Avid Bioservices. We are raising revenue projections for the curr. FY’15 [fye 4-30-15] and bringing on new capacity that will help spur future growth by the middle of this year. This capacity will allow us to continue meeting the growing needs of our existing clients, while simultaneously allowing us to be ready for Bavi commercialization. This business is its strongest position ever as we head through the rest of FY’15 and is in a great position for a very strong FY’16.
We expect over the next few months to have the opportunity to further update you on scientific & clinical data at high profile conferences, to be able to update you on the emergence of clinical collaborations to further explore the potential of bavituximab in combination with other IO agents, and to bring online the addl. capacity of Bavi that will help grow the business. With that I’ll now turn the call over to Joe to discuss clinical development activities.
JOE SHAN (VP/Clin.&Reg. Affairs) – CLINICAL TRIALS:
As Steve just clearly outlined for you, while we remain focused on advancing bavituximab toward market approval, we’re simultaneously laying the groundwork for expanding potential use beyond NSCLC. SUNRISE, our Phase III NSCLC trial is progressing according to plan. With more than 150 clinical centers spanning 14 countries now open for enrollment, our focus is fully transitioned from the start-up to the enrollment phase, and we remain on-track to complete patient enrollment by the end of this CY. We’re also pleased with the progress made to date and encouraged by the positive feedback we have heard directly from investigators, who recognize the potential immuno-modulating mechanism of bavituximab and appreciate its safety profile to date. As a reminder, SUNRISE is designed as a Phase III registration trial and has 2 planned interim analyses [ http://www.clinicaltrials.gov/ct2/show/NCT01999673 ]. The 1st is purely to assess safety, and the 2nd will assess both safety & efficacy. As the interim analyses are triggered and a certain number of trial events are reached, in this case deaths, we cannot at this point guide to when these might occur. To protect the integrity of this double-blind trial, an Indep. Data Safety Monitoring Committee (IDMC) has been established to evaluate the data on an ongoing basis and make recommendations to Peregrine as to when the trial should be un-blinded.
In addition to this most advanced clinical trial, our clinical pipeline is supplemented by trials all designed to expand the therapeutic potential of our novel immunotherapy, bavituximab. Today we announced that final data from a Phase I IST which evaluated bavituximab in combination with paclitaxel in patients with HER2-negative metastatic Breast Cancer has been accepted for publication [Dr. Alison Stopeck] in the peer-reviewed journal Cancer Medicine and will be available online in the coming weeks. The positive data from this trial along with data from 2 prior clinical trials in advanced breast cancer makes this an exciting opportunity for the company and we continue to evaluate opportunities to advance the clinical development of bavituximab in this indication.
Also during the quarter, we announced data [1-16-15 ASCO Gastro-Symposium: http://tinyurl.com/m9uz9moshow ]from the Phase II IST evaluating bavituximab in combination with sorafenib in patients with advanced Liver Cancer, which was conducted by Dr. Adam Yopp, Assistant Professor of Surgery at the UTSW-MC/Dallas. Data demonstrated that the combination of bavituximab & sorafenib resulted in an improved time-to-progression of 6.7mos. and the disease specific survival of 8.7mos. Importantly, the combination of bavituximab & sorafenib was well tolerated in patients with advanced HCC, with no indications of auto-immune adverse events which have been seen with other check-point immunotherapies. This trial is also the subject of an oral presentation by Dr. Yopp at the Society of Surgical Oncology (SSO) at the Annual Cancer Symposium towards the end of this month [March 25-28 2015 http://tinyurl.com/q667hua ]. Also recall that translational data from 6 patients in this study were presented last November at the Society of Immunotherapy of Cancer Annual Meeting [11-8-14 SITC'14: http://tinyurl.com/pchzr6h ]. These data were generative through Dr. Dmitry Gabrilovich, a member of our Scientific Advisory Board and program leader of translational tumor immunology at the Wistar Institute. These data demonstrated an increase in cytotoxic T lymphocytes in the tumor following just one cycle of treatment with bavituximab & sorafenib. These results from treated patients are consistent with that which has been shown previously with PS targeting antibodies and multiple preclinical cancer models, specifically that bavituximab can block immunosuppression within the tumor microenvironment and induce an anti-tumor immune response. Taking together, we along with Dr. Yopp, believe that further evaluation is warranted in a larger randomized trial as resources permit.
Finally, over the past year, we’ve also invested in developing new assays that we are incorporating into trials to assess immune changes within the tumor microenvironment and characterize changes in numbers & types of immune cells. Today we announced that 3 posters have been accepted for presentation at the upcoming AACR Annual Meeting in April, and one of these posters will discuss data generated using a proprietary ex vivo system using patient tumors which was developed by the lab of Dr. Scott Antonia, another member of our SAB and the Thoracic Oncology Dept Chair and the immunology program leader at the H. Lee Moffitt Cancer Center in Florida. We believe that these activities & accomplishments over the past year further build on our foundation for development of bavituximab in combination with chemotherapies as well as with immune-checkpoint inhibitors. Meanwhile we continue to expand our growing network of thought leaders as well as potential clinical collaborators with the goal of spreading the word about our novel PS targeting-based immunotherapy platform and plan to advance the most promising combinations into the clinic as opportunities & resources permit.
JEFF HUTCHINS (VP/Preclinical Research):
As Steve mentioned, as part of our immuno-oncology dev. program, we have continued to deliver snapshots aimed at elucidating & highlighting a broad picture of bavituximab in multiple preclinical indications, with the ultimate goal of uncovering the most effective immune activating combinations. When we initiated this program in June 2013, we assembled a detailed plan designed to guide clinical dev. decision making through a series of preclinical studies to lead into translational trials in patients. These steps are absolutely critical when building a foundation for future clinical trials. I am proud of what Peregrine and our collaborators have accomplished in examining both the preclinical PS science & targeting platform by looking at multiple combinations, thereby discovering the most robust immune-oncology combination, with us seeing today now how bavituximab potentially plays a role in breaking resistance to anti-PD1 monotherapy.
Building on our strategy to disseminate our findings within the scientific & clinical medical communities, we recently presented data at the 2014 San Antonio Breast Cancer Symposium (SABCS) [12-12-14: http://tinyurl.com/p5ng6vs ] showing that the single-agent pre-clin. equivalent to bavituximab demonstrated statistically significant tumor growth inhibition as well as statistically significant increases in the % of CD4 & CD8 tumor infiltrating lymphocytes and decreases in tumor associated myeloid-derived suppressor cells (MDSC’s), all of which are key indicators of immune activation in breast tumor models when compared to a control antibody. These data confirm that the mechanism of action of bavituximab functions independent of PD-1 checkpoint blockade, therefore further highlighting our opportunity for additive or synergistic effects with IO combination therapy. As well, as the Keystone Immunology Meeting, which brought together leading scientists across multiple disciplines, we presented data showing that PS targeting antibodies, when combined with an anti PD-1 antibody, displayed statistically significant improvements in the number of tumor fighting immune cells, their activation signals associated with these cells, and the immune activated in cytokines in models of Melanoma compared to an anti PD-1 antibody alone. In addition, we saw that the cells that suppress the immune system’s ability to recognize the tumor such as MDSC’s were reduced by more than 40% in combination with the PS targeting antibodies versus anti PD-1 antibody alone. I hope that what you can see from our very successful IO dev. program, is that our results are not only positive but very consistent across multiple tumor types. These data demonstrate that the combination of a PS targeting antibody and the checkpoint inhibitor achieve statistically significant tumor growth suppression as well as significantly increased levels of immune cell expansion & activation. As Joe mentioned in his remarks, similar immune activation events were observed in HCC [Liver] patients, thus painting a consistent translational picture from preclinical-to-clinical as to the breadth of bavituximab’s ability as a combination therapy. I can tell you that data from these studies & clinical translational data from trials are being well received and, as such, we plan to continue to actively engage members of the scientific & medical communities with the goal of highlighting this potential of bavituximab throughout the coming years.
Looking to next month, 2 preclinical posters have been accepted for presentation at the 2015 AACR Annual Meeting focusing further on defining the deep impact of PS targeting agents in combination with immune checkpoint inhibitors on stimulating & sustaining T-Cell activation. It is our strong belief that these data, along with the data that we have discussed with you over the past several months, support bavituximab as a potential treatment capable of converting these non-responding anti-PD-1 therapy patients into clinical responders.
CFO Paul Lytle:
Turning to our financials, it’s important to note that we continue to closely manage our operations in line with our cap position, while balancing our various sources of capital. And one important source of capital is derived from our contract mfg. business, Avid Bioservices, which generated $5.7mm in revenue this qtr and $17.4mm for the current 9mo. period. This represents a 46% increase in revenue over the same prior year qtr, and a 10% increase over the same 9mo. period. As we look to the future, I would also like to emphasize that we have a strong backlog for future services in the amount of $29mm as of 1-31-15. This current backlog covers services to be completed during the remainder of FY’15 and into FY’16, and based on our fiscal YTD revenue and our anticipated completion of near-term projects under this backlog, we are raising our contract mfg. revenue guidance from $19-23mm to $23-25mm for the full FY’15.
In addition to a strong revenue qtr, last December we shared with you strategic plans to expand our mfg. capacity to help support the revenue growth of Avid as well as creating sufficient mfg. capacity for the potential commercial launch of bavituximab. Growing this revenue generating business is very important to us, as it reduces the amount of capital & funding we would need to raise by other means. We have made significant progress this qtr in constructing this new mfg. clean-room, and we remain on track to commence manufacturing in this new facility during mid-2015.
Now turning to expenses, we saw an expected increase in R&D spending this qtr to $11.3mm, as we continue to invest in the SUNRISE space retrial. This resulted in an increase in our net loss to ~$13mm this qtr, with a corresponding increase in our net cash burn from operations to $11.1mm, representing our reported net loss minus non-cash expenses. In conclusion, let me say that our financial goals are centered on maintaining a solid cash position and investing these proceeds into our novel immuno-oncology program, led by bavituximab, and our revenue generating mfg. business. We will continue to closely manage our operations in line with our cap position while balancing our various sources of capital. We look forward to updating you on our progress.
Q&A: [20:10 mark]
1. Joe Pantginis – Roth Capital Partners: [ http://www.roth.com & https://roth2.bluematrix.com/docs/pdf/BLUE.pdf ]
JP: ”Logistical question re: SUNRISE - I know you don’t give specific numbers, but do you feel that enrollment rates have been performing as expected?”
Joe Shan: Yes, I think things are going pretty much according to plans.
JP: And then, more towards the broader lung cancer indication - last Friday, Dr. Richard Pazdur [FDA Center for Drug Eval. & Res. – 3-4-15: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436534.htm ] made some comments regarding the approval of Opdivo, that docetaxel really shouldn’t necessarily be the std. anymore or a comparator in clinical studies. Is that going to have any potential impact on your ability to enroll patients into SUNRISE?”
Steve King: Yes, we did get some questions on the comments that he made. There are few things to keep in mind. One is that he was specifically referring to Squamous NSCLC - in fact, those patients are actually excluded from our study, so, we’re in Non-Squamous NSCLC. So, we don’t expect that that will have any overriding impact on enrollment in our study whatsoever. In the broader scheme of things, the question is, does this somehow affect our trial design or in some way impact our overall program? We’re very confident that, and the way we’re going about things, is to focus on the things that we can control, #1. Not that nothing else is going to happen in the marketplace, because you never know, but basically this was the reason we had an End-of-Ph2-meeting with the FDA. We got clearly their buy-off on the trial design which included the comparator arm. So, we’re very confident from our standpoint that we’re on track, and if we have statistically significant positive results in our study, that we should be in a great position for approval.
Rob Garnick: I totally agree, I know Dr. Pazdur pretty well. I’ve worked with him in the past, and I think his comments on the Squamous NSCLC trial with Opdivo are right on. However, as Steve said, we are in the Non-Squamous population, which is a totally different disease. Our agreements with FDA on the Phase III trial design are something that typically FDA is not going to go back on and make changes and disagree with the end-point and trial design. So I think we’re in a very strong position that should the trial be positive, as we would expect, that we will be able to obtain a good approval, relatively rapid because approval for the product because we do have the fast-track designation. So, I’m not worried about that and I also agree that it will have absolutely no effect on the accrual of patients in the trial itself. I do think that with the really great results that have been reported for Opdivo, it makes me particularly interested in combination trails with bavituximab because one of the real advantages of bavituximab is that it has an extremely good safety profile, which is actually highly unusual both in immuno-oncology drugs as well as in chemotherapy drugs in general. So, the ability to combine bavituximab with drugs like, Opdivo, and I’m sure Joe has talked about addl. trials that he’s thinking about. I’m sure in the future we’re going to see these types of combination trials come to fruition, and this will lead to label expansions and one of other very positive things for the development of bavituximab as an oncology agent.
JP: That’s very helpful Rob. I guess, even by the time SUNRISE reads out, you will have already generated more data both clinically & pre-clinically to talk to the potential potentiation of the combination and that’s something we’re looking forward to. Thanks for the added color.
Steve King: Think that’s exactly what Jeff was talking about earlier and Joe has been talking about, this is an exciting opportunity to be able to combine with Opdivo and the other PD-1, PDL-1 inhibitors that are out there. And I think that’s a grand opportunity because, while these are great results, not everyone is getting cured, and what’s needed is still to drive more patients toward being able to respond to these great new immuno-oncology drugs. Clearly we’ve shown in pre-clinical studies and now some translational data that bavituximab has that potential. So, it’s just another exciting opportunity and we look forward to addressing it.
2. Thomas Yip (MLV & Co.): http://www.mlvco.com
TY: ” I see that Avid’s revenues grew by $1.8mm this qtr vs. LY, that’s pretty impressive. With the backlog of $29mm, how do you see the expanded capability of the new plan affect the amount of that backlog?
Steve King: The backlog of the business is at this point is strictly based on the current facility. What we’re doing is adding on the ability to really grow that significantly. So, it’s really two-fold. #1, it allows us to continue to grow the base business to meet the growing demands of our existing clients as well as new clients that are coming in, and at the same time be ready for bavituximab’s commercial launch. I think that it’s a great opportunity; I really view this as a great growth business. Clearly the revenue growth this year we’re expecting to be very nice and setting the stage for really nice FY’16 [May’15-Apr’16] coming up. So, it’s great to have this new addition coming online just at a time when we maybe can take the most advantage of it.
TY: ”You mentioned preparing for bavituximab U.S. launch. Will this new capacity be able to cover the anticipated demand for NSCLC in the U.S.?
Steve King: That’s exactly what the planning was in building up the facility, to be able to meet the commercial launch. Now, if we’re successful with bavituximab in as many indications as we think we can be then, yes, we may need another facility. But at that point that will probably easier to address. We’ve definitely built it really with bavituximab commercial launch and commercial supply in mind. And I think it’s one of the other interesting things about the developments with Opdivo, for instance, in that they got accelerated approval , based on some great clinical data, but they were in a position to take advantage of that because they already had the mfg. in place. This is one of the beauties of the model we have here, which is that since we do have this mfg. capacity in hand, we do have the ability, should we be fortunate enough to have some early good results come from one of the interim looks in the study, to potentially take advantage of that. That’s the other thing that’s great from having this new facility online is it allows us to be able to meet that. Rob, do you want to add anything to that?
Rob Garnick: That’s a really good point. A lot of companies have actually stumbled in the past because they had a drug that worked but they weren’t able to produce the satisfactory commercial supply. But we certainly have size & designs planned in order to produce both the launch capability and actually out a number of years in the expansion of the drug into the marketplace. So, I agree with Steve, I think we should be so lucky as to have the problem of having to build another plant - that would be out good doing.
TY: Where will the cost of this plan show up in the P&L and over how long a period of time?
Paul Lytle: The current asset that we’re building is currently tracked under construction & progress on our balance sheet. So, the actual cost will be stored there and then we’ll depreciate this asset over a number of years and that will show up in cost as we mfg. for customers.
3. George Zavoico – Jones Trading
GZ: ” Avid followup - did ever you mention how much the expansion is going to cost? And if you have or if you can, how long before you get the return on that investment with the increased business through the backlog?
Paul Lytle: We haven’t said exactly what the total facility is going to cost us, just from a competition standpoint. I think as soon as we build it we’re going to have kind of a launch party for the actual asset; it will show up in our balance sheet when it is officially launched. In terms of capitalizing on this asset, our goal is basically to put as many customers into this facility as we can. Initially, bavituximab will just need a handful of mfg. runs to prepare for commercialization. And then, the remaining amount of capacity is available for3rd-party customers and depending on how we execute on our future potential business, I think the return on investment should be fairly quick.
GZ: ”How much Avid business is for the largest customer and what % of the capacity is now by 1 or 2 or 3 of your customers? How dependent are you on 1 or 2 or 3 customers, in other words?”
Paul Lytle: If you look at on the segment reporting on our 10-Q, it breaks out the customers. I believe Halozyme Therapeutics represents ~80% of our revenue that’s reported for the past qtr.
GZ: With regard to SUNRISE, have you disclosed how many events have to happen for the interim analysis, the 1st one and the 2nd one? And have those number of events changed? And how much effect does that have on the powering?
Joe Shan: We’ve just given a broad guidance; it’s pretty standard. The 1st interim is at 33% of events, it’s a futility look, mainly you look at safety; the 2nd one is at 50% events.
GZ: ”50%?”
Joe Shan: Yes. So that’s not changed. And as I mentioned in my prepared remarks, we’re not monitoring that and watching that daily, that’s the job of the IDMC.
Steve King: We obviously can’t really control when we’ll make it to those events; they’re driven by patterns of patient enrollments and by patient outcomes, so it’s even more unpredictable to guess when those might be. But it’s a pretty standard sign and any alpha hit was taken into account in the overall trial design.
GZ: ”Finally, a little more general to strategic questions. It’s becoming pretty clear I think that Opdivo & PD-1, that these checkpoint inhibitors have already arrived on the market, have tremendous efficacy and a derivative response for a relatively small proportion, 20% to 30%, of patients. And, that combining checkpoint inhibitors such as bavituximab with either of those could potentially greatly improve the efficacy without really compromising the safety. From a strategic point of view, if you’re Merck or Bristol-Myers, would you want to lock up the use of a 2nd immune checkpoint inhibitor like Bavi with just one of those to capture more of the market, or expand the market, for particular indication or until there are indications - is that a viable strategy for some of the big pharmaceutical companies and does that play into your discussions with some of the partners that you’re talking to?
Steve King: Clearly, combinations are the name of the game now in the immuno-oncology space. We believe that based on our safety profile and what we’ve seen so far in the tumor microenvironment changes, as well as the actual data coming out of our studies, that we’re potentially a really great combination partner with any other PD-1, PDL-1 players. Absolutely, these kinds of things can come into the discussions. From our standpoint, we would like to be able to look at as broad a collection of those types of agents as we can, because while in theory they all behave the same, you never know what you’re going to see clinically. At this point, there is no reason to believe PD-1 or PDL-1 is going to have a distinct advantage. So, that comes into the discussion. I wouldn’t rule out that we may have multiple collaborations ongoing with different types of agents within the PD-1, PDL-1 space for that reason from our standpoint. So, we want to explore those. But at some point, if we start to show efficacy and we can add to the value of the platform, I think the beauty of combining bavituximab is that effectively we’re not diminishing the size of the PD-1 market, in fact we’re only enhancing it by allowing potentially more patients to respond that otherwise might not respond. So I think that’s absolutely very attractive and obviously the ideal from a pharmaceutical development standpoint.
GZ: ”In order to maintain your independence perhaps as long as possible, because obviously Opdivo and Keytruda are going to be pretty expensive drugs. Could various cooperative groups or potentially different sponsors move into these combinations to maintain your independence and perhaps increase the value when you actually do get to the point of negotiating an agreement?
Steve King: There are lots of possibilities. One is direct collaborations with the pharmaceutical companies that have the drugs in indications where they might not be approved yet. Of course, once the drugs are on the market and become part of the SOC, such as is happening in Melanoma and now coming into Squamous NSCLC, effectively those studies could be run even independently because of the fact that they would be covered by insurance. Then the 3rd of course is the cooperative groups or other groups that may have access to the drugs or a supply of them that can run their own studies. So, what I can say is we’re actively looking at all of those different possibilities and we want to put together the best program that will allow us to answer the questions we’re most interested in.
4. Roy Buchanan for Charles Duncan – Piper Jaffray [http://www.piperjaffray.com – 3-5-13 Initiates PPHM: http://tinyurl.com/bxhntk3 ]
RB: ”Re: SUNRISE, are you planning any presentations this year around the interims or just conduct of the trial or enrollment or anything?
Steve King: I think other than maybe a trial in progress type of presentation at ASCO, the interim data looks as Joe described them, but they’re probably not worthy of their standalone presentation. We’re still blinded.
RB: ”No idea about timing on those at all?
Joe Shan: No.
RB: ”The Phase I ISTs aren’t in your control, but any thoughts on when we might see data from those?”
Steve King: We’re obviously a little bit more actually involved in, and helping to encourage the holders of those ISTs. We’re hopeful that even this year we might be able to start see some of the data coming from those studies. We had a little bit of data from one of the ISTs late last year and early this year from the Liver Cancer study - more data potentially coming from that clinical trial as we complete some of the translational pieces of the dataset and as well as we have another clinical presentation coming up at the end of March. So, I think those will see a bit more activity and then, as we start new studies, that will start the clock ticking on potentially more data coming through. In addition to those, I think as was mentioned in the presentation, we have other data coming from collaboration with Scott Antonia and his group in looking at some addl. data for bavituximab. So, there will be a heavy dose of data coming from the ISTs as well as other kind of preclinical-type activities.
MR. KING’S CLOSING COMMENTS:
I’d like to thank all of you again for participating in today’s call. We strongly believe that the path we are taking on the development front-end will add significant value to the bavituximab program by expanding potential indications & combinations, which helps ensure commercial success. Along with the continued growth of Avid, which adds value through growing 3rd-party revenues, which increases the value of the business, by helping offset the overall cash burn, and perhaps most importantly allowing us to be prepared for bavituximab’s success. Taking together, all these activities should increase shareholder value. And we look forward to that reflection in our market valuation. I thank you all again for your continued support.
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3-12-15 PR: “Peregrine Pharmaceuticals Reports Third Quarter FY 2015 Financial Results and Recent Developments”
• SUNRISE Phase III Lung Cancer Trial On Track to Complete Enrollment by Calendar Year-End
• Encouraging and Consistent Data from Immuno-Oncology Development Program Continue to Support Bavituximab's Immunostimulatory Mechanism
• Avid Bioservices Increases Revenue Guidance to $23-25 mm for Full Fiscal Year 2015 Based on Strong Demand for Services
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=901398
TUSTIN, March 12, 2015: Peregrine Pharmaceuticals, Inc. (Nasdaq:PPHM) (Nasdaq:PPHMP), a biopharmaceutical company focused on advancing bavituximab, a novel immuno-oncology agent in Phase III development, today announced financial results for the third quarter of fiscal year (FY) 2015 ended January 31, 2015. The company also provided an update on its advancing clinical pipeline and reviewed other corporate developments.
"This is an exciting time for the company on many fronts. Our lead clinical program, bavituximab is in a unique position as a Phase III immuno-oncology agent that has shown great potential in combination with both current standard cancer treatments, such as chemotherapy, as well as emerging immuno-oncology agents such as those targeting PD-1 and PD-L1. We have continued to advance the bavituximab Phase III SUNRISE trial and are on track to complete enrollment in the study by year-end," said Steven W. King, President and CEO of Peregrine. "Aside from completing enrollment in the SUNRISE trial, our clinical focus is to enter into new clinical collaborations to further explore the combination potential of bavituximab with anti-PD-1 and PD-L1 in multiple tumor indications and we expect these activities to be quite visible over the coming months as the planning that is underway now, comes to fruition. These efforts, on top of completing the Avid capacity expansion and continued revenue growth, point to many important milestones throughout remainder of 2015."
The company's mission is to develop a brand new class of immunotherapies focused on the clinical advancement of our lead drug candidate bavituximab which targets the immunosuppressive PS signaling pathway. Bavituximab has the potential to be an effective part of treatment regimens in many different tumor types and has recently shown promise in combination with other immuno-oncology compounds in multiple preclinical models of cancer. Over the past quarter, the company has made important progress in bringing this novel immunotherapy closer to the market led by the SUNRISE Phase III clinical trial.
The company continues to enroll patients in the SUNRISE (Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III Lung Cancer Study) trial. SUNRISE is a Phase III, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety, tolerability and efficacy of bavituximab as a second-line treatment in patients with non-squamous, non-small cell lung cancer (NSCLC). The trial is evaluating bavituximab plus the standard chemotherapy docetaxel versus docetaxel plus placebo in approximately 600 patients at clinical sites worldwide. Patients with Stage IIIb/IV non-squamous NSCLC who have progressed after standard front-line treatment are eligible for enrollment. The primary endpoint of the trial is overall survival. The company anticipates completing patient enrollment in the SUNRISE trial by the end of calendar year 2015. For additional information about the SUNRISE trial, please visit http://www.sunrisetrial.com or http://ClinicalTrials.gov using the Identifier NCT01999673. [ http://www.clinicaltrials.gov/ct2/show/NCT01999673 ]
The company's commitment to exploring the full clinical potential of bavituximab in combination with chemotherapies or other immuno-oncology agents is being executed through a series of Investigator-Sponsored Trials (IST) in multiple solid tumor indications. The following represents anticipated upcoming data from ongoing or completed clinical studies as well as the status of trials that can yield data in the future:
Final data from a Phase I IST that evaluated bavituximab in combination with paclitaxel in patients with HER2-negative metastatic breast cancer has been accepted for publication [Dr. Alison Stopeck] in the peer-reviewed journal Cancer Medicine and will be published online in the coming weeks. The company is currently evaluating opportunities to advance the clinical development of bavituximab in breast cancer.
Data from a Phase II IST that evaluated bavituximab in combination with sorafenib in patients with advanced hepatocellular carcinoma (HCC), or liver cancer, presented at the 2015 Gastrointestinal Cancers Symposium Data [1-16-15 ASCO Gastro-Symposium: Ph.2 data/n=38 (Adam Yopp), ‘These clinical outcomes of TTP=6.7/DCR=58%/PFS=4mo are quite encouraging…’ http://tinyurl.com/m9uz9moshow ] that the combination of bavituximab and sorafenib is associated with an improved time to progression (TTP) of 6.7 months, a disease specific survival (DSS) of 8.7 months, a disease control rate (DCR) of 58% (22 out of 38 patients) and a 4-month progression-free survival (PFS) of 62%. Two patients (5%) achieved a partial response according to Response Evaluation Criteria In Solid Tumors (RECIST). The secondary endpoint of median overall survival (OS) was 6.2 months. The combination of bavituximab and sorafenib was well-tolerated in patients with advanced HCC with no indications of autoimmune adverse events that have been seen with other checkpoint immunotherapies. During the quarter, translational data from 6 patients from this trial were presented at the Society for Immunotherapy of Cancer's (SITC) 29th Annual Meeting and Associated Programs [11-8-14 SITC'14: http://tinyurl.com/pchzr6h ]. These data, to assess and measure changes in immune response pre- and post-treatment, show the ability of bavituximab to positively regulate an increase in tumor fighting immune cells (particularly CD8 T cells) following one cycle of treatment, thus further confirming in patients what has been shown for PS-targeting antibodies in multiple preclinical cancer models. This trial is also the subject of an oral presentation at the Society of Surgical Oncology's (SSO 2015) 68th Annual Cancer Symposium to be held March 25-28, 2015 in Houston, Texas [See: http://tinyurl.com/q667hua ].
A Phase I IST evaluating bavituximab in combination with capecitabine and radiation therapy in up to 18 patients with Stage II or III rectal adenocarcinoma is open for patient enrollment.
A Phase Ib IST evaluating bavituximab in combination with Bristol-Myers Squibb's ipilimumab (Yervoy®) in up to 24 patients with advanced melanoma is open for patient enrollment.
As part of the company's mission to discover the full potential of its immunotherapy bavituximab in clinical disease applications, the company is advancing studies through its Immuno-Oncology Development Program. This program is designed to explore the potential of combining bavituximab with other immunotherapies, experimental immuno-oncology drugs including checkpoint inhibitors, as well as vaccines.
During the quarter, data presented at the 2014 San Antonio Breast Cancer Symposium (SABCS) [12-12-14: http://tinyurl.com/p5ng6vs ] show that the monotherapy preclinical equivalent to bavituximab demonstrated statistically significant tumor growth inhibition in breast tumor models when compared to a control antibody. Data further show that this monotherapy yielded statistically significant increases in the percentage of tumor fighting T-lymphocytes and decreases in tumor inflammatory myeloid-derived suppressor cells (MDSC), all key indicators of immune activation.
Data presented recently at the Keystone Tumor Immunology meeting [2-9-15: http://tinyurl.com/q6cx4w6 ] show that the PS-targeting antibody equivalent to bavituximab combined with an anti-PD-1 antibody displayed statistically significant improvement in tumor fighting immune cells, activation signals and cytokines in a model of melanoma compared to anti-PD-1 alone. Moreover, cells that suppress the immune system from recognizing tumors, such as MDSCs, were reduced by more than 40% in the combination with the PS-targeting antibody versus anti-PD-1 alone.
Peregrine announced today the acceptance of 3 posters at the American Association for Cancer Research's (AACR) Annual Meeting to be held April 18-22, 2015 in Philadelphia, Pennsylvania. These posters include preclinical data from the company's Immuno-Oncology Development Program of PS-targeting agents in combination with immune checkpoint inhibitors in breast cancer and melanoma, as well as translational research conducted with tumor tissue from lung cancer patients.
The company is also exploring other applications for the PS-targeting platform outside of cancer therapy. These activities include:
PS-TARGETING MOLECULAR IMAGING PROGRAM
The company is exploring the potential of its experimental PS-targeting molecular imaging candidate, 124I-PGN650, in patients with various solid tumor types. This is an open-label, single-center trial with a primary goal of estimating radiation dosimetry in critical and non-critical organs and secondary objectives of tumor imaging and safety.
AVID BIOSERVICES
Avid Bioservices, Inc. is the contract manufacturing subsidiary of Peregrine. Avid provides high quality clinical and commercial manufacturing services under cGMP for the biotechnology and biopharmaceutical industries. As announced in December, Avid is in the process of expanding its manufacturing capacity with a new state-of-the-art facility. Activities supporting this expansion continue and the company remains on track to commence manufacturing in the new facility during mid-2015.
"Our Avid business had another strong quarter further supporting our decision announced in December to expand our manufacturing capacity to meet the growing needs of our manufacturing business as well as the anticipated commercial launch of bavituximab," said Paul Lytle, CFO of Peregrine. "Our current backlog for manufacturing services has increased to $29 mm and we are increasing our revenue guidance from between $19 to $23 mm to between $23 and $25 mm for the full FY 2015."
FINANCIAL RESULTS
Contract manufacturing revenue from Avid's clinical and commercial biomanufacturing services provided to its third-party customers for the third quarter FY 2015 were $5,677,000, compared to $3,885,000 for the same quarter of the prior fiscal year. In addition to providing biomanufacturing services to its third-party customers, Avid will continue to support the potential commercialization of bavituximab.
Total costs and expenses in the third quarter of FY 2015 were $18,699,000, compared to $13,628,000 in the third quarter of FY 2014. This increase was primarily attributable to the current quarter increases in research and development expenses associated with the SUNRISE Phase III trial and cost of contract manufacturing associated with higher contract manufacturing revenue, which were offset by the current quarter decrease in selling, general and administrative expenses. For the third quarter FY 2015, research and development expenses were $11,261,000, compared to $6,649,000 for the third quarter of FY 2014. For the third quarter of FY 2015, cost of contract manufacturing was $3,113,000, compared to $2,416,000 for the third quarter of FY 2014. For the third quarter of FY 2015, selling, general and administrative expenses were $4,325,000 compared to $4,563,000 for the third quarter of FY 2014.
Peregrine's consolidated net loss attributable to common stockholders was $14,027,000, or $0.08 per share, for the third quarter of FY 2015, compared to a net loss attributable to common stockholders of $9,724,000, or $0.06 per share, for the same quarter of the prior year.
Peregrine reported $55,238,000 in cash and cash equivalents as of January 31, 2015 compared to $77,490,000 at fiscal year ended April 30, 2014.
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. [ 10-Q: http://tinyurl.com/mwedt8w ]
CONFERENCE CALL
Peregrine will host a conference call and webcast this afternoon, March 12, 2015, at 4:30 PM EDT (1:30 PM PDT). 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 for the treatment and diagnosis of cancer. The company's lead immunotherapy candidate, bavituximab is in Phase III development for the treatment of second-line non-small lung cancer (the "SUNRISE trial") along with several investigator-sponsored trials evaluating other treatment combinations and additional oncology indications. The company is also advancing a molecular imaging agent, 124I-PGN650, in an exploratory clinical trial for the imaging of multiple solid tumor types. 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. Additional information about Peregrine can be found at http://www.peregrineinc.com.
Safe Harbor *snip*
Yervoy is a registered trademark of Bristol-Myers Squibb.
Contact: Christopher Keenan, Peregrine Pharmaceuticals, Inc., (800) 987-8256 - info@peregrineinc.com
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
THREE MONTHS ENDED JANUARY 31, NINE MONTHS ENDED JANUARY 31,
2015 2014 2015 2014
Unaudited Unaudited Unaudited Unaudited
REVENUES:
Contract manufacturing revenue $ 5,677,000 $ 3,885,000 $ 17,436,000 $ 15,820,000
License revenue -- -- 37,000 107,000
Total revenues 5,677,000 3,885,000 17,473,000 15,927,000
COSTS AND EXPENSES:
Cost of contract manufacturing 3,113,000 2,416,000 10,835,000 9,281,000
Research and development 11,261,000 6,649,000 31,465,000 18,910,000
Selling, general and administrative 4,325,000 4,563,000 13,503,000 12,913,000
Total costs and expenses 18,699,000 13,628,000 55,803,000 41,104,000
LOSS FROM OPERATIONS (13,022,000) (9,743,000) (38,330,000) (25,177,000)
OTHER INCOME (EXPENSE):
Interest and other income 29,000 23,000 108,000 68,000
Interest and other expense (1,000) (4,000) (1,000) (5,000)
NET LOSS $ (12,994,000) $ (9,724,000) $ (38,223,000) $ (25,114,000)
COMPREHENSIVE LOSS $ (12,994,000) $ (9,724,000) $ (38,223,000) $ (25,114,000)
Series E preferred stock accumulated dividends (1,033,000)
--
(2,577,000)
--
NET LOSS ATTRIBUTABLE TO COMMON SHAREHOLDERS $ (14,027,000) $ (9,724,000) $ (40,800,000) $ (25,114,000)
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:
Basic and Diluted 182,519,923 163,223,767 180,562,524 156,521,874
BASIC AND DILUTED LOSS PER COMMON SHARE $ (0.08) $ (0.06) $ (0.23) $ (0.16)
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
JANUARY 31, 2015 APRIL 30, 2014 Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 55,238,000 $ 77,490,000
Trade and other receivables, net 6,284,000 1,332,000
Inventories 6,148,000 5,530,000
Prepaid expenses and other current assets, net 934,000 1,419,000
Total current assets 68,604,000 85,771,000
Property and equipment, net 8,958,000 2,447,000
Other assets 1,559,000 2,327,000
TOTAL ASSETS $ 79,121,000 $ 90,545,000
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 6,814,000 $ 2,434,000
Accrued clinical trial and related fees 3,117,000 4,433,000
Accrued payroll and related costs 3,716,000 3,837,000
Deferred revenue, current portion 5,752,000 5,241,000
Customer deposits 8,311,000 5,760,000
Other current liabilities 490,000 502,000
Total current liabilities 28,200,000 22,207,000
Deferred revenue, less current portion -- 292,000
Other long-term liabilities 1,127,000 347,000
Commitments and contingencies
STOCKHOLDERS' EQUITY:
Preferred stock- $0.001 par value; authorized 5,000,000 shares; issued and outstanding - 1,180,004 and 775,000, respectively 1,000 1,000
Common stock- $0.001 par value; authorized 325,000,000 shares; outstanding - 184,244,698 and 178,871,164, respectively 184,000 179,000
Additional paid-in capital 491,098,000 470,785,000
Accumulated deficit (441,489,000) (403,266,000)
Total stockholders' equity 49,794,000 67,699,000
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 79,121,000 $ 90,545,000
- - - - - - - - -
[ From 10-Q header: “As of Mar. 6, 2015, there were 188,332,872 shares of issuer’s common stock.”
- - - - - - - - - - - - - - - - -
Latest 10K 4-30-14 iss. 7-14-14: http://tinyurl.com/mhva3k3 PR: http://tinyurl.com/o2e4a4g (Cash 4-30-14=$77.5mm)
Latest 10Q 1-31-15 iss. 3-12-15 http://tinyurl.com/mwedt8w PR: http://tinyurl.com/q78oxvm (Cash 1-31-15=$55.2mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
.
.
= = = = = = = = = = = = = = = = = = = = = = = = = = = =
Updated PPHM REVS-BY-QTR TABLE, now thru FY15/Q3 (qe 1-31-15), per the 1-31-15 10-Q ( http://tinyurl.com/ksjrqge ) issued 3-12-15. Deferred-Revs at 1-31-15, going fwd into FY’15/Q4 (fy/e 4-30-15), total $5.8mm, up from the $3.6mm of Deferred-Revs at 10-31-14 that drove into FY’15/Q3.
Total Revs since May’06: ($119.9mm/Avid + $24.1mm/Govt + $2.1mm/Lic.) = $146.2mm
Avid’s Gross-Profit over last 3 qtrs: $6.6mm on revs of $17.4mm (GM% = 38%)
=> Recall, Avid Rev$ 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$ GM%
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%
*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
Totals: 119904 24149 2124 146177 <=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
...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 13,000,000
= = = = = = = =
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)
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
*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.”
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- - - - - - - - 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)
= = = = = = = = = = = =
“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
= = = = = = = = = = 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."
= = = = = = = = = = = = = = = = = = http://www.peregrineinc.com
Peregrine’s Corp. Fact Sheet updated 3-12-2015:
http://www.peregrineinc.com/images/stories/pdfs/fact_sheet_march_2015.pdf Pg1:
.
.
= = = = = = = = = = = = = = =
3-9-15: CEO Steve King’s 24min. talk at ROTH Conf. (DanaPT CA) - SLIDES http://tinyurl.com/p873grw
12-10-14 Qtly. Conf. Call (King/Shan/Hutchins/Lytle) Transcript http://tinyurl.com/kmdgq8t
...CEO S.King: “We believe Peregrine is in a unique position with an immune-oncology program already in Phase III, with what has been a positive safety profile and a target that is ideal for combining with other IO agents.”
10-16-14 Peregrine ASM: Slides(42), Audio-Replay-Link, Attendee-Reports http://tinyurl.com/oyc3e5v
9-9-14 Qtly. Conf. Call (King/Hutchins/Shan/Lytle) Transcript http://tinyurl.com/ktrfswj
...CEO S.King: “In addition to our clinical trials, many of which have also have translational data points built in to tie together pre-clin. data with the clinic, we have also continued to build momentum in our pre-clin. collaborations which now number in the dozens. We are evaluating new combinations & dosing strategies combining bavituximab with chemotherapy, radiation, and immune-oncology approaches, including those targeting CTLA-4, PD-1, as well as other downstream immune checkpoints."
7-14-14 Qtly. Conf. Call (King/Shan/Hutchins/Worsley/Lytle) Transcript http://tinyurl.com/o2e4a4g
...CEO S.King: “Partnering remains a priority with the goal being to use partnerships to continue expanding the bavituximab program, while we continue to execute the SUNRISE Phase III trial.”
3-10-14: CEO Steve King’s 22min. talk at ROTH Conf. (DanaPT CA) - SLIDES http://tinyurl.com/n65myfk
3-7-14 Qtly. Conf. Call (King/Shan/Garnick/Lytle) Transcript http://tinyurl.com/kh9cnrg
...CEO S.King: “I don't want to overuse the word ‘excitement’, but these are truly exciting times that have positioned us for success on all fronts.”
12-10-13 Qtly. Conf. Call (King/Shan/Garnick/Hutchins/Worsley/Lytle) Transcript http://tinyurl.com/mw776mk
...CEO S.King: “We believe that Peregrine is uniquely positioned among the companies developing immunotherapies… and that because of our current valuation, we represent a unique investment opportunity.
• All of Dr. Robert Garnick's public comments (thru 3-7-2014) while at Peregrine: http://tinyurl.com/obvwyuh Steve King said 6-29-11, "Rob is the ringmaster."
• 6-29-11 Minyanville article, "Peregrine Pharma's Secret Weapon [Robert Garnick]" http://tinyurl.com/9jtnan o
• Examples of Dr. Garnick's work at Genentech on Avastin (bevacizumab) approvals: http://tinyurl.com/yg7vtqa
PS-TARGETING SCIENCE: "Evolution has favored pathogenesis that resembles apoptosis."
Dr. Judah Folkman: ”This [Thorpe’s VTA research] is very promising and very elegant work... The whole goal is really 2-part, reducing the harsh side effects of cancer treatment, and reducing the chance that some cancer cells will evade treatment. That would be a big step in the next decade, and anti-vascular therapy will play a major role." (’97 & ’02 http://tinyurl.com/k5qe96g & http://tinyurl.com/n6vh9hp )
Peregrine's Bavituximab & Cotara Technologies: http://www.peregrineinc.com/technology/overview.html
Peregrine's Clinical Trials website: http://PeregrineTrials.com
- - - - - - - -
Bavituximab MOA & Clinical Data: http://www.peregrineinc.com/pipeline/bavituximab-oncology.html
...Bavi Publications: http://www.peregrineinc.com/publications/publications.html
...Bavi Posters & Presentations: http://www.peregrineinc.com/publications/posters-and-presentations.html
Bavi MOA: Video (3:34) added ~3-2014 http://vimeo.com/87116642 "Bavituximab: A Novel Immunotherapy Candidate Targeting an Upstream Immune Checkpoint to Fight Cancer"
Bavi MOA: Video (1:33) on Bavi’s Immunotherapeutic MOA added to Youtube on 3-27-14 https://www.youtube.com/watch?v=Esewl35JD8s
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
BAVI MOA 12-12-14 San Antomio Breast Cancer Symposium, Dr. Bruce Freimark, Bavi+anti-PD-1 vs. Breast Cancer http://tinyurl.com/p5ng6vs
BAVI MOA 11-2014 SITC’14: 3 posters on preclin. Bavi+aCTLA4/aPD1 combo data (Hutchins Freimark Brekken Huang etal) http://tinyurl.com/pchzr6h
BAVI MOA 8-28-14: Italy’s Dr. Federico Cappuzzo, Bavi/NSCLC profile article (DovePress OpenAccess, 7pgs) - http://tinyurl.com/n3oa7bc
BAVI MOA 8-11-14: PPHM/VP Dr. Jeff Hutchins’ presentation at ImVacS "Immunotherapies & Vaccine Summit", Boston - PR: http://tinyurl.com/lpjy3u7 ; PDF(31 Slides): http://tinyurl.com/oueldme
...MLV’s Dr. George Zavoico’s 8-27-14 report on Dr. Jeff Hutchins’ 8-11-14 ImVacS/Boston Bavi MOA presentation: http://tinyurl.com/l3tw63c
BAVI MOA 5-28-14: Dr. Rolf Brekken’s 47min CRI “Cancer Immunotherapy” webinar about Bavituximab as an Upstream/Global Immune Checkpoint Inhibitor – REPLAY: http://tinyurl.com/lxgftyx
. . .CRI=Cancer Research Institute (NYC – Supported by BMS): http://www.cancerresearch.org - Facebook: http://tinyurl.com/pbmhb2z , https://twitter.com/CancerResearch
. . .CRI launches “Answer to Cancer” (cancer immunotherapy) website http://www.theanswertocancer.org
. . .8-12-14: CRI adds Youtube links to the 5-28-14 CRI Immunotherapy webinar, incl. Dr. Brekken's talk "about Bavi and how it works against lung, liver, and other kinds of cancers" http://tinyurl.com/ps5h6h8
BAVI MOA 3-25-14: Dr. Rolf Brekken’s 40min talk at NYAS Lung Cancer Symposium http://tinyurl.com/lq9stnk (45 Slides)
. . .Dr.Brekken’s talk: “Antibody-mediated Inhibition of PS - A Novel Strategy for Immune Checkpoint Blockade” (the 5 speakers: Jessica Donington, Roy Herbst, Balazs Halmos, Suresh Ramalingam, Rolf Brekken)
12-10-13: With recent scientific insights highlighting bavi’s immunostimulatory moa, these additions to PPHM’s SAB: Dimitry Gabrilovich, Scott Antonia, David Carbone**, Hakan Mellstedt http://tinyurl.com/mw776mk
......**A/o 9-2014, Dr. David Carbone (PPHM SAB/KOL) is President-Elect of IASLC https://www.iaslc.org/about-us/board
BAVI MOA: 12-2013 Bavi’s Immunotherapeutic MOA overviewed by UTSW’s Brekken/Huang in Pan European Networks Jrnl. http://tinyurl.com/lnb46pq
BAVI MOA 11-9-13: Annual SITC (WashDC) – 2 posters about Bavi’s Immunostimulatory MOA http://tinyurl.com/mjaweu5
...“We are actively working towards initiating a clinical trial in the coming months to further investigate the potential synergistic effects of bavituximab and an approved [anti-CTLA-4] immunotherapy in patients with Melanoma."
10-28-13 IASLC/Sydney: “Immune Checkpoints in the Tumor Environment: Novel Targets & the Clinical Promise of Combined Immunotherapies” http://tinyurl.com/mjaweu5
…Symposium speakers: Scott J. Antonia/MD-PhD(H.Lee Moffitt CC), Dmitry I. Gabrilovich/MD-PhD(Wistar Inst), Rolf A. Brekken/PhD(UTSW), David E. Gerber/MD(UTSW)
BAVI MOA: 8-19-13 Data Supporting Bavituximab’s Immunotherapy MOA Published in “Cancer Immunology Research” (AACR) - http://tinyurl.com/mhjftka (PDF)
…“PS-Targeting Antibody Induces M1 Macrophage Polarization & Promotes Myeloid-Derived Suppressor Cell Differentiation” (Thorpe etal)
BAVI MOA: 8-13-13 PPHM/VP Dr. Jeff Hutchins’ Presentation on the Downstream Immunostimulatory Effects/Moa of PS-targeting antibodies (like Bavi) at CHI’s “Immunotherapies Congress”/Boston http://tinyurl.com/m6h2tvt
BAVI MOA: 10-12-12 NMB article on how Bavi "Induces Innate & Specific Anti-tumor Responses" http://tinyurl.com/cw9odb8
BAVI MOA: 5-1-12 Dr. Phil Thorpe's 46min talk at NYAS PS-Targeting Symposium http://tinyurl.com/9792gl5
. . .Symposium title: "Phosphatidylserine (PS) Asymmetry - Therapeutic Apps. in Cancer & Infectious Disease Symposium"
. . .Replays of 5 speakers: Alan Schroit, Chris Reutlingsperger, David Ucker, Ari Helenius, Philip Thorpe
BAVI MOA: 5-26-11 Dr.Thorpe's keynoter at Recombinant-Mabs/Barcelona http://tinyurl.com/3klpodc & http://tinyurl.com/3m33h33
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