Thursday, July 17, 2014 2:00:42 PM
7-14-14 Qtly CC-Transcript, PR(Financials/Devs Q4FY14/fye4-30-14), updated Avid Revenues History Table By Quarter…
=> Total Revs May06-Apr14: $102.5mm/Avid + $24.1mm/Govt + $2.1mm/Lic. = $128.7mm
This large post has 3 sections:
I. 7-14-14 Q4/FY14 Qtly. Earnings Conf. Call TRANSCRIPT (q/e 4-30-14)
II. 7-14-14 PPHM Press Release: Q4/FY14 Earnings & Developments
III. Updated Table of Avid Revenues By Quarter (May’06-Current)
…Recall: Peregrine’s FY runs May-Apr, so FY’14 = May’13-Apr’14.
((( Orig. transcript from SeekingAlpha.com [ http://tinyurl.com/me4o2v9 ], with numerous corrections made. )))
Link to webcast replay:
http://ir.peregrineinc.com/events.cfm => http://www.media-server.com/m/p/sa5skxns
FULL TRANSCRIPT…
7-14-2014 Q4 FY’14 Earnings Conf. Call (fy/e 4-30-14)
WELCOME & FWD-LOOKING STATEMENTS: Chris Keenan (IR) http://www.peregrineinc.com
Speakers: Steve King, Joe Shan, Jeff Hutchins, Steve Worsley, Paul Lytle; Q&A session.
CEO STEVE KING – OPENING COMMENTS:
Thanks to all of you for participating in this afternoon’s call. This quarter capped off a busy year for Peregrine, including the many activities associated with running the bavituximab SUNRISE Phase III trial [ http://www.clinicaltrials.gov/ct2/show/NCT01999673 ], the continued successful evolution of our bavituximab immunotherapy program that has yielded encouraging preclinical data leading to our first immunotherapy combination in clinical trial this quarter. We also have an expanding research program, including new collaborations and another solid revenue quarter for our mfg. subsidiary Avid Bioservices. This helped us exceed our stated revenue projections.
As you will hear from Joe Shan, our VP of Clinical & Regulatory, during the quarter we focused on the continued execution of the ongoing SUNRISE trial, which is evaluating bavituximab + docetaxel in 2nd-Line NSCLC. We now have over 100 global clinical sites initiated, speaking to the large scale of the trial as well as the logistical challenge. We are happy with the progress in the study and look forward to completing enrolment in the trial by the end of next year. As an aside, I’ve had a chance to meet many of the investigators and coordinators involved in the study and really enjoyed seeing their enthusiasm for being involved in the trial. There is a strong recognition of the importance of this study and general excitement in being involved in developing a new immunotherapy approach to lung cancer therapy. We look forward to continuing to update you as the study continues to expand and as we move closer to interim data points for the trial. Joe will give an update on this in more detail during his prepared remarks.
Besides the SUNRISE trial, we’ve also been very active on the clinical & preclinical research fronts. Our goal is to attract academic-, clinical-, and industry-led collaborations in order to explore the full potential of bavituximab as a novel immunotherapy. These efforts include our IST program, which already has ongoing trials in Liver, Front-Line NSCLC, Rectal cancer, and the new trial evaluating our first immunotherapy combination with Yervoy in Melanoma. We have already seen important data coming out of these studies with more expected in the future. Joe again will update us on these ongoing clinical studies shortly. It is important to note that each of these clinical studies was supported by robust preclinical data, and as Jeff will cover during his remarks we’re expanding our collaborations to explore even more immunotherapy combinations that can result in future clinical avenues for development. We expect these efforts to be fruitful from the standpoint of expanding the potential indications for bavituximab and as a great source of news flow over the coming year. Steve Worsley, our VP of Business Dev., will update you on his efforts to help drive these important collaborations with potential partners as well as the current progress in seeking development partnerships. 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.
Turning to financials, while we utilized cost effective strategies, such as employing the IST model as part of our clinical development strategy, there are initiatives such as the SUNRISE Phase III trial that we’re advancing on our own terms & timeline. This approach allows us to continue adding value to the program on our timeline and, as new data supporting expanded combination comes to light and new uses of bavituximab are realized, we feel this value will only be amplified. We continue to maintain a balanced financial approach to operating the business and as Paul Lytle, our CFO, will explain, our contract mfg. business Avid Bioservices had another strong year, one on which we can continue to build upon. I’m pleased with the progress made throughout the pipeline, including the successful rollout to date of our immunotherapy development program. With recent reports forecasting that the global market for cancer immunotherapies will reach almost $9B in 2022, compared with just $1.1B two years ago, we believe the potential of bavituximab to play a key role in this therapeutic area is greater than ever. I’ll now turn the call over to Joe Shan to discuss clinical progress.
JOE SHAN (VP/Clin.&Reg. Affairs) – CLINICAL TRIALS:
Let me first say how pleased I’m with the progress of startup activities for the SUNRISE trial over the past few months, which is a complex & lengthy process, especially in the European & Asia-Pacific regions. Our internal team and vendor partners have been working tirelessly to coordinate all the various submissions and timely responses, in order to obtain approvals necessary to conduct this global clinical trial. These approvals range from the national gov’t level to ethics committee & institutional approval, to shipment import permissions, and as a result we’ve now activated over 100 clinical sites worldwide in SUNRISE trial, but more planned to come online over the next few months. We remain on track to complete enrollment of approx. 600 patients by the end of 2015, with 2 planned event-driven interim data analyses. As part of these initiation activities, we’re implementing an extensive education initiative for investigators and thought leaders in conjunction with scientific & medical conferences such as the ASCO Annual Meeting and at Peregrine-hosted events. We conducted several meetings where investigators & key opinion leaders (KOLs) reviewed details on the SUNRISE file as well as our overall bavituximab development pipeline. The attendance & active participation at these meetings, especially in cases such as ASCO where many companies are vying for people’s time, is a strong indicator, not only of the level of enthusiasm for the SUNRISE trial, but also for the bavituximab program overall.
We plan to continue expanding these initiatives and increase bavituximab awareness at key conferences throughout the year. While we continue to execute our plans with SUNRISE trial, we’re also advancing bavituximab development as a novel immunotherapy in other solid tumor indications.
Starting with Breast Cancer, we’ve now generated data from 3 separate clinical trials combining bavituximab with taxane chemotherapy. The most recent is from an investigator sponsored trial or IST by Dr. Alison Stopeck of the Univ. of Arizona Cancer Center in Tucson [ http://azcc.arizona.edu/profile/alison-stopeck ], in which she previously reported an 85% response rate, including a 15% complete response rate in patients with HER2-negative metastatic breast cancer. [6-3-13: ASCO’13/interim data, n=14: ORR=85%, 2 CR’s (15%) http://tinyurl.com/kq3uv4e ] Given these results in which approx. half of the patients were Triple-Negative and extremely difficult to treat disease and the immune-stimulatory synergies that exist between bavituximab & taxane, Breast Cancer is high on our list of next indications. We look forward to the publication of final data in a manuscript form from this trial from Dr. Stopeck in the near future.
Now we’re also encouraged by what we’re hearing from the Liver Cancer IST led by Dr. Adam Yopp of the UTSW-MC/Dallas [ http://profiles.utsouthwestern.edu/profile/110771/adam-yopp.html ] and look forward to his presentation of the clinical results upon maturity. As patient enrolment and treatment continues, clinical samples are being collected & analyzed, examine changes in patients’ immune response to treatment. This translational work is designed to recapitulate the immune-stimulating mechanism of about PS targeted antibodies observed in preclinical models, and we plan to present data at a future conference.
Furthermore, we announced this quarter the initiation of the first immunotherapy-only clinical trial combining bavituximab with an approved check point inhibitor. The Phase I IST sponsored by Dr. Art Frankel, Professor of Internal Medicine at UTSW-MC/Dallas [ http://profiles.utsouthwestern.edu/profile/138072/arthur-frankel.html ] will test bavituximab in combination with Yervoy, an approved anti-CTLA-4 checkpoint inhibitor in up to 24 patients with Advanced Melanoma. As you will hear from Jeff in a moment, this clinical trial represents the next stage in development of bavituximab with other immunotherapeutic strategies and is directly supported by preclinical models for this novel combination. As this is an open-label 2-arm randomized, single-center trial with numerous immune endpoints, we hope to provide interim data update throughout the trial.
[note: BMS’s “Yervoy” = Ipilimumab (anti-CTLA-4) http://www.yervoy.com ]
And with that, I’ll turn the call over to Jeff to review our preclinical initiatives as well as our collaboration goals.
JEFF HUTCHINS (VP/Preclinical Research):
In addition, we’re very pleased with the data emerging from the bavituximab immunotherapy development program. And as such, continue to be aggressive in ensuring that we’re presenting this to the most appropriate scientific & medical audiences. This quarter we had the opportunity to present at 2 Keystone symposia and the AACR Annual Meeting, further validating the immune-stimulatory mechanism of action of bavituximab and its potential in both oncology & anti-viral therapeutic areas.
At the Keystone symposia and the AACR Meeting, data was presented showing that a combination of a PS targeting antibody equivalent to bavituximab and an anti-CTLA-4 or an anti-PD-1 antibody exhibited greater tumor growth suppression and longer survival than an anti-CTLA-4 or an anti-PD-1 antibody alone. As well, these animals that survived the initial tumor challenge developed tumor-specific protective immunity that were resistant to re-challenge of the initial tumor. In a separate study, also presented at the AACR Conference, an equivalent antibody to bavituximab administered with stereotactic body Radiation Therapy showed a 100% improvement in survival and favorable tumor eradication in a model of NSCLC compared to radiation therapy alone.
[4-2014 AACR'14: Peregrine's 3 posters http://tinyurl.com/k4fl8z6 - about Bavi as an “Upstream PS Checkpoint Inhibitor”; notably, “when combined with downstream immune checkpoint inhibitors such as anti-CTLA-4 and anti-PD-1, PS targeting mediates an improved protective tumor-specific immunity following tumor rechallenge”, and, “combination of bavituximab with the anti-PD-1 checkpoint blockade should synergistically induce potent long-lasting antitumor immunity.”]
As part of a broader strategy in the anti-viral area, researchers presented data showing that a PS-binding antibody inhibited HIV infection of cells by indirectly blocking viral receptors used by HIV to facilitate infection.
[3-2014: Keystone Conf./Alberta PS-Targeting/HIV Poster by PPHM’s Cyril Empig & Duke/Peregrine Co-Authors Barton Haynes/Tony Moody/etc. http://tinyurl.com/m6kuqpr ]
As you can see, these are very encouraging data that we have been able to share with the scientific community over the past few months and served as a very important step in validating our programs. As well, we continue to pursue new internal & collaborative efforts to further evaluate and expand bavituximab combination opportunity. These data, along with the translational work that our teams have done, have allowed us to execute the next step in our development program, the movement from the laboratory setting into the clinic, just as we did with the melanoma IST that Joe just discussed. With that, I’ll turn it over to Steve Worsley for a review of the business development & collaboration goals.
Steve Worsley (VP/Business Dev.):
Today I will speak to our strategy as it pertains partnering as it has greatly evolved over the last 2 years, partly due to 2 events, the 1st of those being the Phase II experience in Sept. 2012 and the 2nd, the subsequent data from Phil Thorpe’s lab validating the immune-stimulatory mechanism of bavituximab. When taken together, partnering should be thought of in a very different light than in early 2012. Essentially there are 2 partnering buckets that we’d like to fill. As it is clear that we were able to efficiently execute the SUNRISE Phase III trial, our goal is to seek a partner to assist us in advancing bavituximab into indications into the mid-stage clinical trials that have shown early clinical promise that Jeff & Joe alluded to. We believe that data to date supports several indications which we’re including in our discussion. We are also seeking collaborators that build on what we’ve just heard from Joe & Jeff regarding other checkpoints of pathways such as PD-1, IDO, immune-stimulatory drugs, and even vaccines. These will be very early stage collaborations, aimed at enhancing the data to emerge from the ongoing Phase Ib IST in advanced Melanoma. We continue to have discussions with numerous potential partners and updating them with new data as it emerges from the program. If they’re in an immune-oncology space or have a drug candidate that can be leveraged by the immune-stimulatory mechanism of bavituximab, they’re certainly on our radar. This past quarter with data from Keystone at AACR in hand, we were able to engage several prominent companies. This is a process that takes time and should not be rushed. We have a clear idea of how we want to advance bavituximab and a key will be to find a partner aligned with that vision. We are working as efficiently as possible, we appreciate your patience and we look forward to updating you as to the progress in this area. With that, I’ll turn it over to Paul for a review of the financials for the quarter.
= = = = = = = = = = = = = = = = = = = =
[ 1st Peregrine mention of “IDO” inhibitors that I’ve heard – examples:
• Incyte’s immune checkpoint inhibitor INCB24360 is an oral inhibitor of IDO1 (indoleamine dioxygenase-1) – http://www.incyte.com
• NewLink Genetics’ immune checkpoint inhibitor indoximod is an oral inhibitor of IDO (indoleamine 2,3-dioxygenase) – http://newlinkgenetics.com
“IDO pathway inhibitors are another class of immune check point inhibitors akin to the recently developed antibodies targeting CTLA-4 & PD-1 that represent potential breakthrough approaches to cancer therapy.” ]
CFO Paul Lytle:
Let me shift gears now and spend the next few moments covering a few financial highlights and our related financial goals. Starting with our revenue generating business Avid Bioservices, a year ago we guided that our FY14 contract mfg. revenue was expected to be $18-22mm, and I am pleased to say that we beat those expectations with $22.3mm in contract mfg. revenue for the full FY14. This was partly driven by a strong Q4 where Avid generated over $6mm in revenue. We expect FY15 to be another good year and project that contract mfg. revenue will be $19-23mm based on our current commitments. Now in addition to providing clinical & commercial mfg. to our clients, Avid is strategically aligned to support the commercial supply of bavituximab, and we are evaluating options that would support the potential commercial launch of bavituximab in addition to supporting the continued growth of Avid’s business.
Now let me turn to our Net Loss and our Operating Cash Burn which is calculated by taking our net loss and deducting non-cash expenses. As expected our net loss increased to $35.4mm in FY14 as we supported the Phase III SUNRISE Trial and other corporate matters. But it's important to note that when you deduct non-cash expenses from this figure, such as depreciation and share-based compensation, our operating cash burn for FY14 was significantly reduced to $28.2mm. This compares to an operating cash burn of $24.8mm in FY13. Now funding our operating cash burn leads me to our financial goals. As we advance our Phase III SUNRISE Trial and prepare for potential commercialization of bavituximab, we are closely managing our operations, our cash positions, and our various sources of capital. Over the past FY, we have continued to strengthen our cash position to support these development goals and reported over $77mm in cash/cash equivs. as of April 30th, 2014. And last month (June 2014) we raised an addl. $9.5mm in net proceeds from the sale of Series E preferred stock at $25/sh. representing less-dilutive capital with a conversion price of $3/sh. Based on our current cash position, we have the needed capital to fund our operations for at least the next 12 mos. based on our current financial projections. Looking ahead, we will continue to closely manage our operations in line with our cash position while maintaining & balancing our various sources of capital. We have invested in these programs using a balanced financial approach by closely matching our capital needs with our various sources of capital. We look forward to keeping you updated on our progress and we will now open the call up for your questions.
Q&A: [21:01 mark]
1. Charles Duncan – Piper Jaffray [http://www.piperjaffray.com – 3-5-13 Initiates PPHM: http://tinyurl.com/bxhntk3 ]
CD: “Thanks for taking my question and congratulations on a good quarter of progress. So my 1st question is regarding SUNRISE, I appreciate all the color on that Joe and what you’ve been doing to make that happen. 100 sites started up, can you tell us what defines a site startup. Is it actual patients dosing or is it just drug onboard and they’re ready to go, and if it's not patient dosing, can you give us a sense as to what % of those sites have enrolled patients?”
Joe Shan: Hi, Charles. The short answer to that is a std. definition, I mean the site is activated, I mean they’re able to enroll, it doesn’t mean they actually are enrolled. As you can imagine this is a fluid process that, but sites don’t immediately necessarily have eligible patients the second they’re open. So, our definition of site activation is that they have all the approvals and drug on board, ready to go. We’re not going to comment on enrollment patterns or any specifics on that, I think if there’s something material that necessitates that kind of information. In the meantime, I can say that enrollment is going well in all the regions - it's not limited to any particular location.
CD: “Good. A clarification regarding enrollment. I think you said this during your prepared comments, but, to complete enrollment by the end of next year, does that mean the end of FY or CY, and which year you’re talking about, 2016 or 2015?”
Joe Shan: Yes, that’s the end of CY 2015.
CD: “Okay, good. And then you’re including Asian sites as well, that’s intriguing to me because obviously this is a big challenge worldwide, but particularly in Asia. Can you tell us whether or not any of those sites have been Asian?
Joe Shan: Yes, that’s still available on ClinicalTrials.gov [ http://www.clinicaltrials.gov/ct2/show/NCT01999673 ]. Yes, there are few countries that we are activating in Asia. So yes, Taiwan, Korea, and Australia.
CD: “OK, good deal. And then one question on ISTs and then just one on business development. Regarding the ISTs, can you go back and kind of review just briefly the evidence that there might be some synergies with taxane [note: ‘taxanes’ include paclitaxel=Taxol & docetaxel=Taxotere] for utility in breast cancer?”
Joe Shan: Even before the ISTs, you recall, we actually conducted 2 company-sponsored studies with taxane combinations, and those were signal seeking. And we saw very consistent results across not only those 2, but there was a lung cancer trial that was a similar design as well, also with had taxane combination with high response rates prolonged PFS. And then, even very early, on prolonged survival which at that time we did not quite understand the immune mechanism behind that, that might explain that. So, first there was a clinical observation. Now, we also understand that taxanes themselves have some immune-stimulatory mechanisms - primarily, they do have effects on suppressing or inhibiting the suppressor cells that bavituximab also works with. So, I think there’s mechanistic support for that synergy as well.
CD: “OK. And then my question regarding business dev. for Steve is, the way that you describe your efforts and appreciate the need for patients, not that I detect any lack of patients, but it seems like the partnering efforts are more along the lines of strategic rather than big source of cash or a validation, it seems like you’re more focused on partnering bavi with mechanistic rationale, is that true?”
Steve Worsley: Yes, that’s fair. I think strategically we’re looking to add to the mix a company that’s reflective of where we want to take the program in multiple indications. Obviously there’s a strong bent towards looking at regional plays outside the U.S. Those companies tend to be a little bit more aggressive in what they take on. So those are sort of the 2 main thrusts.
Steven King: Just to expand on that Charles. The other aspect, of course, is that there are lots of studies that we could be running. And I think one of the other things we really want to look at in a partner is someone who can come in and really help us to expand the indications. As Joe mentioned earlier, we’ve got some nice data already generated in Breast Cancer, we particularly like the paclitaxel combination. We have another IST ongoing in Liver Cancer, and obviously if you’re talking about Asia-Pacific, that’s a huge indication throughout that region. We’re also looking at it, not just from a pipeline standpoint which is very important, but also from the standpoint of companies that want to really help us to push the program forward in some of these new indications giving us more shots for success and in increasing the value of the program at the same time.
2. George Zavoico (MLV & Co.): http://www.mlvco.com
GZ: “Hi, and good afternoon. Good quarter. Congratulations. Paul, you said that you have enough capital for 12mos. based on current finances. And then you mentioned you had an operating cash burn of about $28.2mm, and you also said you have a strong cash position of $77mm. So ,it seems based on current burn you actually have more than 2 years of cash, so that implies that in effect you’re guiding to greatly increasing your R&D and your SG&A revenue. Can you speak to that discrepancy a little bit perhaps it has to do with starting the Breast Cancer trial?”
Paul Lytle: In terms of my prepared remarks George, I was saying that we had cash for at least the next 12 mos., so we don’t actually guide towards an operating cash burn. We basically always want to tell shareholders that we have enough money to run our business for at least the next year. If you look at the cash burn rate for the past year, it's obviously going to be more than that, but we don’t really guide towards the actual cash burn in our financials or our press releases. One other thing George, our burn rate is for the past 12 mos. - we initiated the bavituximab SUNRISE Trial in Dec.2013.”
GZ: “Right. A little and more than halfway through, yes.”
Paul Lytle: So you would expect the cash burn rate to go up just because we’ll be enrolling a lot more patients this FY than we did last.
GZ: “OK. And then again you’ve held out the prospect of potentially a Breast Cancer trial as well, that’s very interesting as well, to expand on the number of company-sponsored trials that you do. There was also an interesting comment in today’s PR about Avid that I wanted to follow-up on. You mentioned that you wanted to provide Avid with available capacity for continued growth. Now the area of antibody production is now evolving more than just having antibodies. Now there’s antibody drug congregates, there’s engineered antibodies, that sort of thing. Is Avid intending to move into that area where you might be able to do some post antibody production modifications, as it were, to provide your Avid customers with added services in that regard and I imagine that would also increase your burn as well as you expand into your capability there?”
Steve King: As you know we’ve grown Avid over the years and sort of in a very targeted way, and it’s really built around our customers’ needs, whatever we see the market place going, and so antibody-drug conjugates are a hot new area. It does require some specialized equipment and we’ve looked into that and it's actually very doable within our business model. So, I think we’ll leave those options open. As we strategically want to continue to grow the business, obviously keeping in mind bavituximab also will have its own production needs down the road, we’re really looking into the future as where we have our current facility which has gotten busier & busier over the years. We recognize the opportunity for expansion and looking at ways to accomplish that and still maintain this balanced financial approach we have. So yes, strategically we want to grow the business, we want Avid to be bigger and even more successful than it already is. We do view it as being a value driver and of course the biggest value driver would be at some point making lots & lots of bavituximab for the market place, and so we want to be ready for that opportunity as well. But yes, antibody-drug conjugates is a hot area. There are opportunities in fill-finish; there are a lot of things we can do with the business and continue to grow it and we think even early enhance its a set of offerings to match what the market is asking for.
GZ: “Do you have room for expansion at the current site?”
Steve King: We’re looking at what the various options are for that. We have filled up a lot of our existing warehouse space and with current operations now reaching over $20mm+ in annual revenue. So we want to make sure again that we make the right decision when it comes to expansion. We don’t want to try to do something in too small of a space and then have issues with not being successful.
GZ: “And final question regarding Avid since it's obviously a very important part of your revenue stream. Is any single customer greater than say 10%, 20%, 30% or 40% of the business that you’re depending on?”
Paul Lytle: Yes, currently we have 1 customer [Halozyme] that’s disclosed in our segment reporting section of our 10K that makes up, I believe it's over probably near 80% of our contract mfg. revenue.
Steve King: And I think that’s part of the nature of, because that customer has moved into commercial production, so naturally that becomes a much more consistent part and one of the reasons our revenues are much more consistent now than they were say 3 or 4 years ago. So, it's just the very nature of that type of customer. Clearly we want to bring in more of those types of customers and what it comes down to is that our success is built on our customers’ success and biologics production is a very valuable asset, and one of those things that once you start production at facility, it’s very advantageous to be producing there.
GZ: “Absolutely.”
Steve King: So clearly we want to have more opportunities like that.
GZ: “Great. OK, that sounds really good. Good luck with that, and I look forward to more progress announcements in the coming quarters. Thank you very much.”
MR. KING’S CLOSING COMMENTS:
I’d like to thank you all again for participating in today’s call. From our discussion it is clear that we have had a very productive quarter and an eventful year. The strides we’ve made in our clinical pipeline as well as advancing early stage work coming from our immunotherapy development program position us for a strong 2015. Over the next several months, we look to share with you additional strategic decisions aimed at bringing increased value to our pipeline, patients and to our shareholders. So again, thank you very much and we look forward to updating you with this progress on the next call.
.
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7-14-14 PR: Peregrine Pharmaceuticals Reports Fourth Quarter and Year-End Fiscal Year 2014 Financial Results and Recent Developments
• SUNRISE Phase III Trial Initiated at Over 100 Sites Worldwide
• Launch of First Bavituximab Immunotherapy Trial Combining Upstream and Downstream Checkpoint Inhibitors in Advanced Melanoma
• Avid's Contract Manufacturing Revenue Tops $22 Million for Fiscal Year 2014
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=859576
TUSTIN, CA - 07/14/14: Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM) (NASDAQ: PPHMP), a biopharmaceutical company focused on the development of first-in-class monoclonal antibodies for the treatment and diagnosis of cancer, today announced financial results for the fourth quarter and the fiscal year (FY) 2014 ended April 30, 2014 and provided an update on its advancing clinical pipeline and other corporate developments.
"Our overall strategy is focused on advancing the bavituximab clinical program, engaging with potential partners, clinicians and researchers that can help expand potential indications and combinations for bavituximab while we continue to prepare for commercial activities and work toward maintaining the revenue growth seen for our wholly-owned biomanufacturing subsidiary, Avid Bioservices," said Steven W. King, President and CEO of Peregrine. "This past quarter we made significant progress in this strategy by expanding the bavituximab Phase III SUNRISE trial which now has over 100 open sites, assisting in the launch of the first immunotherapy combination trial that will evaluate the therapeutic potential of combining bavituximab with Yervoy® in patients with advanced melanoma and another solid revenue quarter at Avid of over $6M. These activities, along with ongoing and expanded research efforts exploring new combinations for bavituximab, continue to set the stage for exciting developments over the coming year."
BAVITUXIMAB ONCOLOGY PROGRAM HIGHLIGHTS
Lead Indication in Second-Line Non-Small Cell Lung Cancer:
The company continues to actively open additional trial sites worldwide and enroll patients in the SUNRISE (Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III Lung Cancer Study) Phase III Trial. SUNRISE is a Phase III, global, 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-small cell lung cancer (NSCLC). The trial is evaluating bavituximab plus the standard chemotherapy docetaxel versus docetaxel plus placebo in approximately 600 patients at more than 100 clinical sites worldwide. Patients with Stage IIIb/IV non-squamous, NSCLC who have progressed after standard front-line treatment are eligible for enrollment. Patients are being randomized into 1 of 2 treatment arms. All patients are receiving up to six 21-day cycles of docetaxel at 75 milligrams per meter squared plus weekly infusions of either bavituximab (3mg/kg) or placebo until progression or toxicity. The primary endpoint of the trial is overall survival. As of today, over 100 sites worldwide have been initiated in this pivotal trial.
For additional information about the SUNRISE trial please visit http://www.sunrisetrial.com or ClinicalTrials.gov using the Identifier NCT01999673. [ http://www.clinicaltrials.gov/ct2/show/NCT01999673 ]
Clinical Data that Supports New Bavituximab Oncology Indications:
The company is currently evaluating opportunities to advance the clinical development of bavituximab in breast cancer, based on promising data from a Phase I investigator-sponsored trial (IST) that evaluated bavituximab in combination with paclitaxel in 13 patients with HER2-negative metastatic breast cancer including approximately half of the patients that were classified as "triple negative," a traditionally difficult-to-treat patient population. Encouraging interim data from patients that received the treatment combination was presented at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting, showing that 85% of patients achieved an objective tumor response, including 15% of patients achieving a complete response as measured in accordance with RECIST criteria. [6-3-13: ASCO’13/interim data, n=14: ORR=85%, 2 CR’s (15%) http://tinyurl.com/kq3uv4e ]
"The promising results from the Phase I breast cancer trial that were presented at ASCO in 2013 are currently being finalized in a manuscript that I anticipate publishing in the near future," said Alison Stopeck, MD, Professor of Medicine and Director, Clinical Breast Cancer Program at the University of Arizona Cancer Center, Tucson, Arizona. "Based on the encouraging results observed in this trial, including both a favorable safety profile as well as prolonged clinical responses, I believe that additional clinical development is warranted in this indication."
Exploring Additional Bavituximab Indications through Investigator-Sponsored Trials (IST):
A Phase I/II IST evaluating bavituximab in combination with sorafenib in up to 48 patients with advanced hepatocellular carcinoma (Liver Cancer).
A Phase Ib IST evaluating bavituximab in combination with carboplatin and pemetrexed in up to 25 patients with previously untreated Stage IV NSCLC.
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.
BAVITUXIMAB IMMUNOTHERAPY DEVELOPMENT PROGRAM
Through this program, Peregrine continues to explore the potential of combining bavituximab with other immunotherapies, experimental checkpoint inhibitors as well as vaccines. The company has initiated multiple proof-of-concept studies and presented encouraging preclinical data that could support new trials as well as serving as a basis for the ongoing Phase Ib immunotherapy combination trial. Presentation of data from the Phase Ib trial, as well as preclinical and proof-of concept studies are anticipated throughout fiscal year 2015.
During the quarter, the company announced the first clinical trial to emerge from this program with the initiation of an IST of bavituximab in combination with Bristol-Myers Squibb's ipilimumab (Yervoy®), for the treatment of advanced melanoma. This is an open-label, randomized, single-center Phase Ib trial in up to 24 patients. Data from preclinical studies evaluating the combination in a model of melanoma yielded an enhanced anti-tumor activity compared to ipilimumab alone.
During the quarter, data was presented at two Keystone Symposia and the Annual Meeting of the American Association for Cancer Research (AACR) from studies validating the immune-stimulatory mechanism of action of bavituximab. These presentations showed that the combination of a preclinical phosphatidylserine (PS)-targeting antibody and the immune checkpoint inhibitors anti-CTLA-4 or anti-PD-1 antibodies yielded superior anti-tumor immune responses in animal models of melanoma and colon cancer compared to anti-CTLA-4 and PD-1 antibodies alone. In a separate study, an equivalent antibody to bavituximab administered with stereotactic body radiation therapy demonstrated 100% improvement in survival and favorable tumor eradication in a model of non-small cell lung cancer compared to irradiation alone. In the antiviral area, researchers presented data showing that a PS-binding antibody inhibited HIV infection of cells by blocking viral receptors used by HIV for cell entry.
- - - - - - -[
• 4-2014 AACR'14: Peregrine's 3 posters http://tinyurl.com/k4fl8z6 - about Bavi as an “Upstream PS Checkpoint Inhibitor”; notably, “when combined with downstream immune checkpoint inhibitors such as anti-CTLA-4 and anti-PD-1, PS targeting mediates an improved protective tumor-specific immunity following tumor rechallenge”, and, “combination of bavituximab with the anti-PD-1 checkpoint blockade should synergistically induce potent long-lasting antitumor immunity.”]
• 3-2014: Keystone Conf./Alberta PS-Targeting/HIV Poster by PPHM’s Cyril Empig & Duke/Peregrine Co-Authors Haynes/Moody/etc http://tinyurl.com/m6kuqpr ]
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 had a strong fourth quarter and record year generating over $6 million in contract manufacturing revenue in the fourth quarter of FY 2014 and over $22 million in contract manufacturing revenue for the full FY 2014," said Paul Lytle, CFO of Peregrine. "We have also continued to strengthen our cash position over the past fiscal year to over $78 million as of June 30, 2014 as we continue to advance the Phase III SUNRISE trial and prepare for the potential commercialization of bavituximab. Under the company's hybrid business model, Avid is evaluating manufacturing options that would create new manufacturing capacity for the potential commercial launch of bavituximab while also providing Avid with available capacity for its continued growth."
FINANCIAL RESULTS
Total revenues for the fourth quarter of FY 2014 were $6,474,000, compared to $4,254,000 for the same quarter of the prior fiscal year. For FY 2014, total revenues were $22,401,000, compared to $21,683,000 for the prior year. The FY 2014 increase was primarily attributed to an increase in contract manufacturing revenue generated from Avid Bioservices.
Contract manufacturing revenues from Avid's clinical and commercial biomanufacturing services provided to its third-party clients were $22,294,000 for FY 2014 compared to $21,333,000 for FY 2013. Current contract manufacturing commitments from Avid's third-party customers are in excess of $26 million, covering services to be provided during FY 2015 and into FY 2016. Based on these current commitments, Peregrine expects contract manufacturing revenues for FY 2015 to be between $19 and $23 million. In addition to providing biomanufacturing services to its third-party clients, Avid will continue to support the potential commercialization of bavituximab.
Total costs and expenses in the fourth quarter of FY 2014 were $17,003,000, compared to $12,717,000 in the fourth quarter of FY 2013. For FY 2014, total costs and expenses were $58,107,000 compared to $50,035,000 for FY 2013. This increase was primarily attributable to current year increases in research and development expenses and selling, general and administrative expenses. The increase in research and development expenses for FY 2014 compared to FY 2013 was primarily attributable to expenses associated with the preparation and initiation of our Phase III SUNRISE trial combined with an increase in share-based compensation expense (non-cash). The increase in selling, general and administrative expenses for FY 2014 compared to FY 2013 was primarily attributable to increases in share-based compensation expense (non-cash), payroll and related expenses and corporate legal fees. For the fourth quarter FY 2014, research and development expenses were $8,813,000, compared to $5,835,000 for the fourth quarter of FY 2013, and for FY 2014 were $27,723,000, compared to $24,306,000 for FY 2013. For the fourth quarter FY 2014, selling, general and administrative expenses were $4,361,000, compared to $3,665,000 for the fourth quarter of FY 2013 and for FY 2014 were $17,274,000 compared to $13,134,000 for FY 2013.
Peregrine's consolidated net loss attributable to common stockholders was $10,649,000, or $0.06 per share, for the fourth quarter of FY 2014, compared to a net loss attributable to common stockholders of $8,449,000, or $0.06 per share, for the same quarter of the prior year. For FY 2014, net loss attributable to common stockholders was $35,763,000, or $0.22 per share, compared to $29,780,000, or $0.25 per share, for FY 2013.
Peregrine reported $77,490,000 in cash and cash equivalents as of April 30, 2014, compared to $35,204,000 at fiscal year ended April 30, 2013. As of June 30, 2014, the company reported $78,331,000 in cash and cash equivalents.
More detailed financial information and analysis may be found in Peregrine's Annual Report on Form 10-K, which will be filed with the Securities and Exchange Commission today. [ http://www.sec.gov/Archives/edgar/data/704562/000135448814003653/peregrine_10k-043014.htm ]
CONFERENCE CALL
Peregrine will host a conference call and webcast this afternoon, July 14, 2014, 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. A replay of the call will be available starting approximately two hours after the conclusion of the call through July 21, 2014 by calling (855) 859-2056, or (404) 537-3406 and using passcode 66161283. 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-Meyers Squibb.
PEREGRINE PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
Three Months Ended April 30, Twelve Months Ended April 30,
2014 2013 2014 2013
Unaudited Unaudited
REVENUES:
Contract manufacturing revenue $ 6,474,000 $ 4,176,000 $ 22,294,000 $ 21,333,000
License revenue - 78,000 107,000 350,000
Total revenues 6,474,000 4,254,000 22,401,000 21,683,000
COSTS AND EXPENSES:
Cost of contract manufacturing 3,829,000 3,217,000 13,110,000 12,595,000
Research and development 8,813,000 5,835,000 27,723,000 24,306,000
Selling, general and administrative 4,361,000 3,665,000 17,274,000 13,134,000
Total costs and expenses 17,003,000 12,717,000 58,107,000 50,035,000
LOSS FROM OPERATIONS (10,529,000 ) (8,463,000 ) (35,706,000 ) (28,352,000 )
OTHER INCOME (EXPENSE):
Interest and other income 281,000 15,000 349,000 322,000
Interest and other expense - (1,000 ) (5,000 ) (54,000 )
Loss on early extinguishment of debt - - - (1,696,000 )
NET LOSS $ (10,248,000 ) $ (8,449,000 ) $ (35,362,000 ) $ (29,780,000 )
COMPREHENSIVE LOSS $ (10,248,000 ) $ (8,449,000 ) $ (35,362,000 ) $ (29,780,000 )
Series E preferred stock accumulated dividends (401,000 )
(401,000 )
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS $ (10,649,000 ) $ (8,449,000 ) $ (35,763,000 ) $ (29,780,000 )
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:
Basic and Diluted 177,264,434 137,872,343 161,579,649 120,370,333
BASIC AND DILUTED LOSS PER COMMON SHARE $ (0.06 ) $ (0. 06 ) $ (0.22 ) $ (0. 25 )
PEREGRINE PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
AS OF APRIL 30, 2014 AND 2013
2014 2013
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 77,490,000 $ 35,204,000
Trade and other receivables, net 1,332,000 1,662,000
Inventories 5,530,000 4,339,000
Prepaid expenses and other current assets, net 1,419,000 709,000
Total current assets 85,771,000 41,914,000
PROPERTY AND EQUIPMENT:
Leasehold improvements 1,538,000 1,383,000
Laboratory equipment 5,646,000 5,441,000
Furniture, fixtures, office equipment and software 2,679,000 2,627,000
9,863,000 9,451,000
Less accumulated depreciation and amortization (7,416,000 ) (6,773,000 )
Property and equipment, net 2,447,000 2,678,000
Other assets 2,327,000 466,000
TOTAL ASSETS $ 90,545,000 $ 45,058,000
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 2,434,000 $ 2,821,000
Accrued clinical trial and related fees 4,433,000 930,000
Accrued payroll and related costs 3,837,000 3,582,000
Deferred revenue, current portion 5,241,000 4,171,000
Customer deposits 5,760,000 8,059,000
Other current liabilities 502,000 998,000
Total current liabilities 22,207,000 20,561,000
Deferred revenue, less current portion 292,000 292,000
Other long-term liabilities 347,000 445,000
Commitments and contingencies
STOCKHOLDERS' EQUITY:
Preferred stock - $.001 par value; authorized 5,000,000 shares; issued and outstanding - 775,000 and nil, respectively 1,000 -
Common stock - $.001 par value; authorized 325,000,000 shares; issued and outstanding - 178,871,164 and 143,768,946, respectively 179,000 143,000
Additional paid-in-capital 470,785,000 391,521,000
Accumulated deficit (403,266,000 ) (367,904,000
Total stockholders' equity 67,699,000 23,760,000
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 90,545,000 $ 45,058,000
Contact: Christopher Keenan, Peregrine Pharmaceuticals, Inc., (800) 987-8256 - info@peregrineinc.com
- - - - - - - - -
[ From 10-Q header: “As of July 7, 2014, there were 179,209,458 shares of issuer’s common stock
Contact: Christopher Keenan or Jay Carlson
Peregrine Pharmaceuticals, Inc. (800) 987-8256 info@peregrineinc.com
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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 6-30-14=$78.3mm)
Latest 10Q 1-31-14 iss. 3-7-14 http://tinyurl.com/pxcjocw PR: http://tinyurl.com/kh9cnrg (Cash 1-31-13=$63.2mm, 2-15-14=$79.7mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
.
.
= = = = = = = = = = = = = = = = = = = = = = = = = = = =
Updated PPHM REVS-BY-QTR TABLE, now thru FY14/Q4 (fy/e 4-30-14), per the 4-30-14 10-K ( http://tinyurl.com/mhva3k3 ) issued 7-14-14. Deferred-Revs at 4-30-14, going fwd into FY’15/Q1 (q/e 7-31-14), total $5.2mm, up from the $4.3mm of Deferred-Revs at 1-31-14 that drove into FY’14/Q4.
• Total Revs since May’06: ($102.5mm/Avid + $24.1mm/Govt + $2.1mm/Lic.) = $128.7mm
• Avid’s Gross-Profit over last 4 qtrs: $9.2mm on revs of $22.3mm (GM% = 41%)
==> Recall, Avid Rev$ from Gov’t DTRA Contract work (6/30/08 – 4/15/11, totaling $24.15mm), went into GOVT-REVS, not AVID-REVS, in the Financials.
Avid’s website: http://www.avidbio.com
*The 10-Q’s define OPER.BURN as, ”Net cash used in operating activities before chgs. in operating assets & liabilities”.
The 7-21-2001 10Q explains OP.BURN very nicely:
“RESULTS OF OPERATIONS. Before we discuss the Company's total expenses (cash & non-cash expenses), we would like to discuss the Company's operational burn rate (cash expenses used in operations, net of interest and other income) for q/e July 31, 2001 compared to the same period in the prior year. The operational burn rate is calculated by taking the net income (loss) from operations and subtracting all non-cash items, such as the recognition of deferred license revenue, depreciation and amortization and stock-based compensation expense.”
.
- - - - - - - - PPHM’s Fiscal Qtr’s (FY runs May – April):
FY’10-Q3 = q/e 1-31-10 – rep. 3-11-10 Thu (B4 mkt)
FY’10-Q4 = q/e 4-30-10 – rep. 7-14-10 Wed (after mkt)
FY’11-Q1 = q/e 7-31-10 – rep. 9-9-10 Thu (after mkt)
FY’11-Q2 = q/e 10-31-10 – rep. 12-9-10 Thu (after mkt)
FY’11-Q3 = q/e 1-31-10 – rep. 3-11-11 Fri (after mkt)
FY’11-Q4 = q/e 4-30-11 – rep. 7-14-11 Thu (after mkt)
FY’12-Q1 = q/e 7-31-11 – rep. 9-9-11 Fri (B4 mkt)
FY’12-Q2 = q/e 10-31-11 – rep. 12-12-11 Mon (after mkt)
FY’12-Q3 = q/e 1-31-12 – rep. 3-9-12 Fri (after mkt)
FY’12-Q4 = q/e 4-30-12 – rep. 7-16-12 Mon (after mkt)
FY’13-Q1 = q/e 7-31-12 – rep. 9-10-12 Mon (B4 mkt)
FY’13-Q2 = q/e 10-31-12 – rep. 12-10-12 Mon (after mkt)
FY’13-Q3 = q/e 1-31-13 – rep. 3-12-13 Tue (after mkt)
FY’13-Q4 = q/e 4-30-13 – rep. 7-11-13 Thu (after mkt)
FY’14-Q1 = q/e 7-31-13 – rep. 9-9-13 Mon (after mkt)
FY’14-Q2 = q/e 10-31-13 – rep. 12-10-13 Tue (after mkt)
FY’14-Q3 = q/e 1-31-14 – rep. 3-7-14 Fri (B4 mkt)
FY’14-Q4 = q/e 4-30-14 – rep. 7-14-14 Mon (after mkt)
= = = = = = = = = = = =
“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
= = = = = = = = = = 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 7-17-2014:
http://www.peregrineinc.com/images/stories/pdfs/july-2014_corp_fact_sheet.pdf
= = = = = = = = = = = = = = =
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
- - - - - - - -
Bavi MOA: 4-min Video on Bavi’s Immunotherapeutic Moa added to PeregineInc.com on 1-13-2014: http://tinyurl.com/mbd3kta
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
. . .CRI launches “Answer to Cancer” (cancer immunotherapy) website http://www.theanswertocancer.org
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
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
=> Total Revs May06-Apr14: $102.5mm/Avid + $24.1mm/Govt + $2.1mm/Lic. = $128.7mm
This large post has 3 sections:
I. 7-14-14 Q4/FY14 Qtly. Earnings Conf. Call TRANSCRIPT (q/e 4-30-14)
II. 7-14-14 PPHM Press Release: Q4/FY14 Earnings & Developments
III. Updated Table of Avid Revenues By Quarter (May’06-Current)
…Recall: Peregrine’s FY runs May-Apr, so FY’14 = May’13-Apr’14.
((( Orig. transcript from SeekingAlpha.com [ http://tinyurl.com/me4o2v9 ], with numerous corrections made. )))
Link to webcast replay:
http://ir.peregrineinc.com/events.cfm => http://www.media-server.com/m/p/sa5skxns
FULL TRANSCRIPT…
7-14-2014 Q4 FY’14 Earnings Conf. Call (fy/e 4-30-14)
WELCOME & FWD-LOOKING STATEMENTS: Chris Keenan (IR) http://www.peregrineinc.com
Speakers: Steve King, Joe Shan, Jeff Hutchins, Steve Worsley, Paul Lytle; Q&A session.
CEO STEVE KING – OPENING COMMENTS:
Thanks to all of you for participating in this afternoon’s call. This quarter capped off a busy year for Peregrine, including the many activities associated with running the bavituximab SUNRISE Phase III trial [ http://www.clinicaltrials.gov/ct2/show/NCT01999673 ], the continued successful evolution of our bavituximab immunotherapy program that has yielded encouraging preclinical data leading to our first immunotherapy combination in clinical trial this quarter. We also have an expanding research program, including new collaborations and another solid revenue quarter for our mfg. subsidiary Avid Bioservices. This helped us exceed our stated revenue projections.
As you will hear from Joe Shan, our VP of Clinical & Regulatory, during the quarter we focused on the continued execution of the ongoing SUNRISE trial, which is evaluating bavituximab + docetaxel in 2nd-Line NSCLC. We now have over 100 global clinical sites initiated, speaking to the large scale of the trial as well as the logistical challenge. We are happy with the progress in the study and look forward to completing enrolment in the trial by the end of next year. As an aside, I’ve had a chance to meet many of the investigators and coordinators involved in the study and really enjoyed seeing their enthusiasm for being involved in the trial. There is a strong recognition of the importance of this study and general excitement in being involved in developing a new immunotherapy approach to lung cancer therapy. We look forward to continuing to update you as the study continues to expand and as we move closer to interim data points for the trial. Joe will give an update on this in more detail during his prepared remarks.
Besides the SUNRISE trial, we’ve also been very active on the clinical & preclinical research fronts. Our goal is to attract academic-, clinical-, and industry-led collaborations in order to explore the full potential of bavituximab as a novel immunotherapy. These efforts include our IST program, which already has ongoing trials in Liver, Front-Line NSCLC, Rectal cancer, and the new trial evaluating our first immunotherapy combination with Yervoy in Melanoma. We have already seen important data coming out of these studies with more expected in the future. Joe again will update us on these ongoing clinical studies shortly. It is important to note that each of these clinical studies was supported by robust preclinical data, and as Jeff will cover during his remarks we’re expanding our collaborations to explore even more immunotherapy combinations that can result in future clinical avenues for development. We expect these efforts to be fruitful from the standpoint of expanding the potential indications for bavituximab and as a great source of news flow over the coming year. Steve Worsley, our VP of Business Dev., will update you on his efforts to help drive these important collaborations with potential partners as well as the current progress in seeking development partnerships. 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.
Turning to financials, while we utilized cost effective strategies, such as employing the IST model as part of our clinical development strategy, there are initiatives such as the SUNRISE Phase III trial that we’re advancing on our own terms & timeline. This approach allows us to continue adding value to the program on our timeline and, as new data supporting expanded combination comes to light and new uses of bavituximab are realized, we feel this value will only be amplified. We continue to maintain a balanced financial approach to operating the business and as Paul Lytle, our CFO, will explain, our contract mfg. business Avid Bioservices had another strong year, one on which we can continue to build upon. I’m pleased with the progress made throughout the pipeline, including the successful rollout to date of our immunotherapy development program. With recent reports forecasting that the global market for cancer immunotherapies will reach almost $9B in 2022, compared with just $1.1B two years ago, we believe the potential of bavituximab to play a key role in this therapeutic area is greater than ever. I’ll now turn the call over to Joe Shan to discuss clinical progress.
JOE SHAN (VP/Clin.&Reg. Affairs) – CLINICAL TRIALS:
Let me first say how pleased I’m with the progress of startup activities for the SUNRISE trial over the past few months, which is a complex & lengthy process, especially in the European & Asia-Pacific regions. Our internal team and vendor partners have been working tirelessly to coordinate all the various submissions and timely responses, in order to obtain approvals necessary to conduct this global clinical trial. These approvals range from the national gov’t level to ethics committee & institutional approval, to shipment import permissions, and as a result we’ve now activated over 100 clinical sites worldwide in SUNRISE trial, but more planned to come online over the next few months. We remain on track to complete enrollment of approx. 600 patients by the end of 2015, with 2 planned event-driven interim data analyses. As part of these initiation activities, we’re implementing an extensive education initiative for investigators and thought leaders in conjunction with scientific & medical conferences such as the ASCO Annual Meeting and at Peregrine-hosted events. We conducted several meetings where investigators & key opinion leaders (KOLs) reviewed details on the SUNRISE file as well as our overall bavituximab development pipeline. The attendance & active participation at these meetings, especially in cases such as ASCO where many companies are vying for people’s time, is a strong indicator, not only of the level of enthusiasm for the SUNRISE trial, but also for the bavituximab program overall.
We plan to continue expanding these initiatives and increase bavituximab awareness at key conferences throughout the year. While we continue to execute our plans with SUNRISE trial, we’re also advancing bavituximab development as a novel immunotherapy in other solid tumor indications.
Starting with Breast Cancer, we’ve now generated data from 3 separate clinical trials combining bavituximab with taxane chemotherapy. The most recent is from an investigator sponsored trial or IST by Dr. Alison Stopeck of the Univ. of Arizona Cancer Center in Tucson [ http://azcc.arizona.edu/profile/alison-stopeck ], in which she previously reported an 85% response rate, including a 15% complete response rate in patients with HER2-negative metastatic breast cancer. [6-3-13: ASCO’13/interim data, n=14: ORR=85%, 2 CR’s (15%) http://tinyurl.com/kq3uv4e ] Given these results in which approx. half of the patients were Triple-Negative and extremely difficult to treat disease and the immune-stimulatory synergies that exist between bavituximab & taxane, Breast Cancer is high on our list of next indications. We look forward to the publication of final data in a manuscript form from this trial from Dr. Stopeck in the near future.
Now we’re also encouraged by what we’re hearing from the Liver Cancer IST led by Dr. Adam Yopp of the UTSW-MC/Dallas [ http://profiles.utsouthwestern.edu/profile/110771/adam-yopp.html ] and look forward to his presentation of the clinical results upon maturity. As patient enrolment and treatment continues, clinical samples are being collected & analyzed, examine changes in patients’ immune response to treatment. This translational work is designed to recapitulate the immune-stimulating mechanism of about PS targeted antibodies observed in preclinical models, and we plan to present data at a future conference.
Furthermore, we announced this quarter the initiation of the first immunotherapy-only clinical trial combining bavituximab with an approved check point inhibitor. The Phase I IST sponsored by Dr. Art Frankel, Professor of Internal Medicine at UTSW-MC/Dallas [ http://profiles.utsouthwestern.edu/profile/138072/arthur-frankel.html ] will test bavituximab in combination with Yervoy, an approved anti-CTLA-4 checkpoint inhibitor in up to 24 patients with Advanced Melanoma. As you will hear from Jeff in a moment, this clinical trial represents the next stage in development of bavituximab with other immunotherapeutic strategies and is directly supported by preclinical models for this novel combination. As this is an open-label 2-arm randomized, single-center trial with numerous immune endpoints, we hope to provide interim data update throughout the trial.
[note: BMS’s “Yervoy” = Ipilimumab (anti-CTLA-4) http://www.yervoy.com ]
And with that, I’ll turn the call over to Jeff to review our preclinical initiatives as well as our collaboration goals.
JEFF HUTCHINS (VP/Preclinical Research):
In addition, we’re very pleased with the data emerging from the bavituximab immunotherapy development program. And as such, continue to be aggressive in ensuring that we’re presenting this to the most appropriate scientific & medical audiences. This quarter we had the opportunity to present at 2 Keystone symposia and the AACR Annual Meeting, further validating the immune-stimulatory mechanism of action of bavituximab and its potential in both oncology & anti-viral therapeutic areas.
At the Keystone symposia and the AACR Meeting, data was presented showing that a combination of a PS targeting antibody equivalent to bavituximab and an anti-CTLA-4 or an anti-PD-1 antibody exhibited greater tumor growth suppression and longer survival than an anti-CTLA-4 or an anti-PD-1 antibody alone. As well, these animals that survived the initial tumor challenge developed tumor-specific protective immunity that were resistant to re-challenge of the initial tumor. In a separate study, also presented at the AACR Conference, an equivalent antibody to bavituximab administered with stereotactic body Radiation Therapy showed a 100% improvement in survival and favorable tumor eradication in a model of NSCLC compared to radiation therapy alone.
[4-2014 AACR'14: Peregrine's 3 posters http://tinyurl.com/k4fl8z6 - about Bavi as an “Upstream PS Checkpoint Inhibitor”; notably, “when combined with downstream immune checkpoint inhibitors such as anti-CTLA-4 and anti-PD-1, PS targeting mediates an improved protective tumor-specific immunity following tumor rechallenge”, and, “combination of bavituximab with the anti-PD-1 checkpoint blockade should synergistically induce potent long-lasting antitumor immunity.”]
As part of a broader strategy in the anti-viral area, researchers presented data showing that a PS-binding antibody inhibited HIV infection of cells by indirectly blocking viral receptors used by HIV to facilitate infection.
[3-2014: Keystone Conf./Alberta PS-Targeting/HIV Poster by PPHM’s Cyril Empig & Duke/Peregrine Co-Authors Barton Haynes/Tony Moody/etc. http://tinyurl.com/m6kuqpr ]
As you can see, these are very encouraging data that we have been able to share with the scientific community over the past few months and served as a very important step in validating our programs. As well, we continue to pursue new internal & collaborative efforts to further evaluate and expand bavituximab combination opportunity. These data, along with the translational work that our teams have done, have allowed us to execute the next step in our development program, the movement from the laboratory setting into the clinic, just as we did with the melanoma IST that Joe just discussed. With that, I’ll turn it over to Steve Worsley for a review of the business development & collaboration goals.
Steve Worsley (VP/Business Dev.):
Today I will speak to our strategy as it pertains partnering as it has greatly evolved over the last 2 years, partly due to 2 events, the 1st of those being the Phase II experience in Sept. 2012 and the 2nd, the subsequent data from Phil Thorpe’s lab validating the immune-stimulatory mechanism of bavituximab. When taken together, partnering should be thought of in a very different light than in early 2012. Essentially there are 2 partnering buckets that we’d like to fill. As it is clear that we were able to efficiently execute the SUNRISE Phase III trial, our goal is to seek a partner to assist us in advancing bavituximab into indications into the mid-stage clinical trials that have shown early clinical promise that Jeff & Joe alluded to. We believe that data to date supports several indications which we’re including in our discussion. We are also seeking collaborators that build on what we’ve just heard from Joe & Jeff regarding other checkpoints of pathways such as PD-1, IDO, immune-stimulatory drugs, and even vaccines. These will be very early stage collaborations, aimed at enhancing the data to emerge from the ongoing Phase Ib IST in advanced Melanoma. We continue to have discussions with numerous potential partners and updating them with new data as it emerges from the program. If they’re in an immune-oncology space or have a drug candidate that can be leveraged by the immune-stimulatory mechanism of bavituximab, they’re certainly on our radar. This past quarter with data from Keystone at AACR in hand, we were able to engage several prominent companies. This is a process that takes time and should not be rushed. We have a clear idea of how we want to advance bavituximab and a key will be to find a partner aligned with that vision. We are working as efficiently as possible, we appreciate your patience and we look forward to updating you as to the progress in this area. With that, I’ll turn it over to Paul for a review of the financials for the quarter.
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[ 1st Peregrine mention of “IDO” inhibitors that I’ve heard – examples:
• Incyte’s immune checkpoint inhibitor INCB24360 is an oral inhibitor of IDO1 (indoleamine dioxygenase-1) – http://www.incyte.com
• NewLink Genetics’ immune checkpoint inhibitor indoximod is an oral inhibitor of IDO (indoleamine 2,3-dioxygenase) – http://newlinkgenetics.com
“IDO pathway inhibitors are another class of immune check point inhibitors akin to the recently developed antibodies targeting CTLA-4 & PD-1 that represent potential breakthrough approaches to cancer therapy.” ]
CFO Paul Lytle:
Let me shift gears now and spend the next few moments covering a few financial highlights and our related financial goals. Starting with our revenue generating business Avid Bioservices, a year ago we guided that our FY14 contract mfg. revenue was expected to be $18-22mm, and I am pleased to say that we beat those expectations with $22.3mm in contract mfg. revenue for the full FY14. This was partly driven by a strong Q4 where Avid generated over $6mm in revenue. We expect FY15 to be another good year and project that contract mfg. revenue will be $19-23mm based on our current commitments. Now in addition to providing clinical & commercial mfg. to our clients, Avid is strategically aligned to support the commercial supply of bavituximab, and we are evaluating options that would support the potential commercial launch of bavituximab in addition to supporting the continued growth of Avid’s business.
Now let me turn to our Net Loss and our Operating Cash Burn which is calculated by taking our net loss and deducting non-cash expenses. As expected our net loss increased to $35.4mm in FY14 as we supported the Phase III SUNRISE Trial and other corporate matters. But it's important to note that when you deduct non-cash expenses from this figure, such as depreciation and share-based compensation, our operating cash burn for FY14 was significantly reduced to $28.2mm. This compares to an operating cash burn of $24.8mm in FY13. Now funding our operating cash burn leads me to our financial goals. As we advance our Phase III SUNRISE Trial and prepare for potential commercialization of bavituximab, we are closely managing our operations, our cash positions, and our various sources of capital. Over the past FY, we have continued to strengthen our cash position to support these development goals and reported over $77mm in cash/cash equivs. as of April 30th, 2014. And last month (June 2014) we raised an addl. $9.5mm in net proceeds from the sale of Series E preferred stock at $25/sh. representing less-dilutive capital with a conversion price of $3/sh. Based on our current cash position, we have the needed capital to fund our operations for at least the next 12 mos. based on our current financial projections. Looking ahead, we will continue to closely manage our operations in line with our cash position while maintaining & balancing our various sources of capital. We have invested in these programs using a balanced financial approach by closely matching our capital needs with our various sources of capital. We look forward to keeping you updated on our progress and we will now open the call up for your questions.
Q&A: [21:01 mark]
1. Charles Duncan – Piper Jaffray [http://www.piperjaffray.com – 3-5-13 Initiates PPHM: http://tinyurl.com/bxhntk3 ]
CD: “Thanks for taking my question and congratulations on a good quarter of progress. So my 1st question is regarding SUNRISE, I appreciate all the color on that Joe and what you’ve been doing to make that happen. 100 sites started up, can you tell us what defines a site startup. Is it actual patients dosing or is it just drug onboard and they’re ready to go, and if it's not patient dosing, can you give us a sense as to what % of those sites have enrolled patients?”
Joe Shan: Hi, Charles. The short answer to that is a std. definition, I mean the site is activated, I mean they’re able to enroll, it doesn’t mean they actually are enrolled. As you can imagine this is a fluid process that, but sites don’t immediately necessarily have eligible patients the second they’re open. So, our definition of site activation is that they have all the approvals and drug on board, ready to go. We’re not going to comment on enrollment patterns or any specifics on that, I think if there’s something material that necessitates that kind of information. In the meantime, I can say that enrollment is going well in all the regions - it's not limited to any particular location.
CD: “Good. A clarification regarding enrollment. I think you said this during your prepared comments, but, to complete enrollment by the end of next year, does that mean the end of FY or CY, and which year you’re talking about, 2016 or 2015?”
Joe Shan: Yes, that’s the end of CY 2015.
CD: “Okay, good. And then you’re including Asian sites as well, that’s intriguing to me because obviously this is a big challenge worldwide, but particularly in Asia. Can you tell us whether or not any of those sites have been Asian?
Joe Shan: Yes, that’s still available on ClinicalTrials.gov [ http://www.clinicaltrials.gov/ct2/show/NCT01999673 ]. Yes, there are few countries that we are activating in Asia. So yes, Taiwan, Korea, and Australia.
CD: “OK, good deal. And then one question on ISTs and then just one on business development. Regarding the ISTs, can you go back and kind of review just briefly the evidence that there might be some synergies with taxane [note: ‘taxanes’ include paclitaxel=Taxol & docetaxel=Taxotere] for utility in breast cancer?”
Joe Shan: Even before the ISTs, you recall, we actually conducted 2 company-sponsored studies with taxane combinations, and those were signal seeking. And we saw very consistent results across not only those 2, but there was a lung cancer trial that was a similar design as well, also with had taxane combination with high response rates prolonged PFS. And then, even very early, on prolonged survival which at that time we did not quite understand the immune mechanism behind that, that might explain that. So, first there was a clinical observation. Now, we also understand that taxanes themselves have some immune-stimulatory mechanisms - primarily, they do have effects on suppressing or inhibiting the suppressor cells that bavituximab also works with. So, I think there’s mechanistic support for that synergy as well.
CD: “OK. And then my question regarding business dev. for Steve is, the way that you describe your efforts and appreciate the need for patients, not that I detect any lack of patients, but it seems like the partnering efforts are more along the lines of strategic rather than big source of cash or a validation, it seems like you’re more focused on partnering bavi with mechanistic rationale, is that true?”
Steve Worsley: Yes, that’s fair. I think strategically we’re looking to add to the mix a company that’s reflective of where we want to take the program in multiple indications. Obviously there’s a strong bent towards looking at regional plays outside the U.S. Those companies tend to be a little bit more aggressive in what they take on. So those are sort of the 2 main thrusts.
Steven King: Just to expand on that Charles. The other aspect, of course, is that there are lots of studies that we could be running. And I think one of the other things we really want to look at in a partner is someone who can come in and really help us to expand the indications. As Joe mentioned earlier, we’ve got some nice data already generated in Breast Cancer, we particularly like the paclitaxel combination. We have another IST ongoing in Liver Cancer, and obviously if you’re talking about Asia-Pacific, that’s a huge indication throughout that region. We’re also looking at it, not just from a pipeline standpoint which is very important, but also from the standpoint of companies that want to really help us to push the program forward in some of these new indications giving us more shots for success and in increasing the value of the program at the same time.
2. George Zavoico (MLV & Co.): http://www.mlvco.com
GZ: “Hi, and good afternoon. Good quarter. Congratulations. Paul, you said that you have enough capital for 12mos. based on current finances. And then you mentioned you had an operating cash burn of about $28.2mm, and you also said you have a strong cash position of $77mm. So ,it seems based on current burn you actually have more than 2 years of cash, so that implies that in effect you’re guiding to greatly increasing your R&D and your SG&A revenue. Can you speak to that discrepancy a little bit perhaps it has to do with starting the Breast Cancer trial?”
Paul Lytle: In terms of my prepared remarks George, I was saying that we had cash for at least the next 12 mos., so we don’t actually guide towards an operating cash burn. We basically always want to tell shareholders that we have enough money to run our business for at least the next year. If you look at the cash burn rate for the past year, it's obviously going to be more than that, but we don’t really guide towards the actual cash burn in our financials or our press releases. One other thing George, our burn rate is for the past 12 mos. - we initiated the bavituximab SUNRISE Trial in Dec.2013.”
GZ: “Right. A little and more than halfway through, yes.”
Paul Lytle: So you would expect the cash burn rate to go up just because we’ll be enrolling a lot more patients this FY than we did last.
GZ: “OK. And then again you’ve held out the prospect of potentially a Breast Cancer trial as well, that’s very interesting as well, to expand on the number of company-sponsored trials that you do. There was also an interesting comment in today’s PR about Avid that I wanted to follow-up on. You mentioned that you wanted to provide Avid with available capacity for continued growth. Now the area of antibody production is now evolving more than just having antibodies. Now there’s antibody drug congregates, there’s engineered antibodies, that sort of thing. Is Avid intending to move into that area where you might be able to do some post antibody production modifications, as it were, to provide your Avid customers with added services in that regard and I imagine that would also increase your burn as well as you expand into your capability there?”
Steve King: As you know we’ve grown Avid over the years and sort of in a very targeted way, and it’s really built around our customers’ needs, whatever we see the market place going, and so antibody-drug conjugates are a hot new area. It does require some specialized equipment and we’ve looked into that and it's actually very doable within our business model. So, I think we’ll leave those options open. As we strategically want to continue to grow the business, obviously keeping in mind bavituximab also will have its own production needs down the road, we’re really looking into the future as where we have our current facility which has gotten busier & busier over the years. We recognize the opportunity for expansion and looking at ways to accomplish that and still maintain this balanced financial approach we have. So yes, strategically we want to grow the business, we want Avid to be bigger and even more successful than it already is. We do view it as being a value driver and of course the biggest value driver would be at some point making lots & lots of bavituximab for the market place, and so we want to be ready for that opportunity as well. But yes, antibody-drug conjugates is a hot area. There are opportunities in fill-finish; there are a lot of things we can do with the business and continue to grow it and we think even early enhance its a set of offerings to match what the market is asking for.
GZ: “Do you have room for expansion at the current site?”
Steve King: We’re looking at what the various options are for that. We have filled up a lot of our existing warehouse space and with current operations now reaching over $20mm+ in annual revenue. So we want to make sure again that we make the right decision when it comes to expansion. We don’t want to try to do something in too small of a space and then have issues with not being successful.
GZ: “And final question regarding Avid since it's obviously a very important part of your revenue stream. Is any single customer greater than say 10%, 20%, 30% or 40% of the business that you’re depending on?”
Paul Lytle: Yes, currently we have 1 customer [Halozyme] that’s disclosed in our segment reporting section of our 10K that makes up, I believe it's over probably near 80% of our contract mfg. revenue.
Steve King: And I think that’s part of the nature of, because that customer has moved into commercial production, so naturally that becomes a much more consistent part and one of the reasons our revenues are much more consistent now than they were say 3 or 4 years ago. So, it's just the very nature of that type of customer. Clearly we want to bring in more of those types of customers and what it comes down to is that our success is built on our customers’ success and biologics production is a very valuable asset, and one of those things that once you start production at facility, it’s very advantageous to be producing there.
GZ: “Absolutely.”
Steve King: So clearly we want to have more opportunities like that.
GZ: “Great. OK, that sounds really good. Good luck with that, and I look forward to more progress announcements in the coming quarters. Thank you very much.”
MR. KING’S CLOSING COMMENTS:
I’d like to thank you all again for participating in today’s call. From our discussion it is clear that we have had a very productive quarter and an eventful year. The strides we’ve made in our clinical pipeline as well as advancing early stage work coming from our immunotherapy development program position us for a strong 2015. Over the next several months, we look to share with you additional strategic decisions aimed at bringing increased value to our pipeline, patients and to our shareholders. So again, thank you very much and we look forward to updating you with this progress on the next call.
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7-14-14 PR: Peregrine Pharmaceuticals Reports Fourth Quarter and Year-End Fiscal Year 2014 Financial Results and Recent Developments
• SUNRISE Phase III Trial Initiated at Over 100 Sites Worldwide
• Launch of First Bavituximab Immunotherapy Trial Combining Upstream and Downstream Checkpoint Inhibitors in Advanced Melanoma
• Avid's Contract Manufacturing Revenue Tops $22 Million for Fiscal Year 2014
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=859576
TUSTIN, CA - 07/14/14: Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM) (NASDAQ: PPHMP), a biopharmaceutical company focused on the development of first-in-class monoclonal antibodies for the treatment and diagnosis of cancer, today announced financial results for the fourth quarter and the fiscal year (FY) 2014 ended April 30, 2014 and provided an update on its advancing clinical pipeline and other corporate developments.
"Our overall strategy is focused on advancing the bavituximab clinical program, engaging with potential partners, clinicians and researchers that can help expand potential indications and combinations for bavituximab while we continue to prepare for commercial activities and work toward maintaining the revenue growth seen for our wholly-owned biomanufacturing subsidiary, Avid Bioservices," said Steven W. King, President and CEO of Peregrine. "This past quarter we made significant progress in this strategy by expanding the bavituximab Phase III SUNRISE trial which now has over 100 open sites, assisting in the launch of the first immunotherapy combination trial that will evaluate the therapeutic potential of combining bavituximab with Yervoy® in patients with advanced melanoma and another solid revenue quarter at Avid of over $6M. These activities, along with ongoing and expanded research efforts exploring new combinations for bavituximab, continue to set the stage for exciting developments over the coming year."
BAVITUXIMAB ONCOLOGY PROGRAM HIGHLIGHTS
Lead Indication in Second-Line Non-Small Cell Lung Cancer:
The company continues to actively open additional trial sites worldwide and enroll patients in the SUNRISE (Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III Lung Cancer Study) Phase III Trial. SUNRISE is a Phase III, global, 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-small cell lung cancer (NSCLC). The trial is evaluating bavituximab plus the standard chemotherapy docetaxel versus docetaxel plus placebo in approximately 600 patients at more than 100 clinical sites worldwide. Patients with Stage IIIb/IV non-squamous, NSCLC who have progressed after standard front-line treatment are eligible for enrollment. Patients are being randomized into 1 of 2 treatment arms. All patients are receiving up to six 21-day cycles of docetaxel at 75 milligrams per meter squared plus weekly infusions of either bavituximab (3mg/kg) or placebo until progression or toxicity. The primary endpoint of the trial is overall survival. As of today, over 100 sites worldwide have been initiated in this pivotal trial.
For additional information about the SUNRISE trial please visit http://www.sunrisetrial.com or ClinicalTrials.gov using the Identifier NCT01999673. [ http://www.clinicaltrials.gov/ct2/show/NCT01999673 ]
Clinical Data that Supports New Bavituximab Oncology Indications:
The company is currently evaluating opportunities to advance the clinical development of bavituximab in breast cancer, based on promising data from a Phase I investigator-sponsored trial (IST) that evaluated bavituximab in combination with paclitaxel in 13 patients with HER2-negative metastatic breast cancer including approximately half of the patients that were classified as "triple negative," a traditionally difficult-to-treat patient population. Encouraging interim data from patients that received the treatment combination was presented at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting, showing that 85% of patients achieved an objective tumor response, including 15% of patients achieving a complete response as measured in accordance with RECIST criteria. [6-3-13: ASCO’13/interim data, n=14: ORR=85%, 2 CR’s (15%) http://tinyurl.com/kq3uv4e ]
"The promising results from the Phase I breast cancer trial that were presented at ASCO in 2013 are currently being finalized in a manuscript that I anticipate publishing in the near future," said Alison Stopeck, MD, Professor of Medicine and Director, Clinical Breast Cancer Program at the University of Arizona Cancer Center, Tucson, Arizona. "Based on the encouraging results observed in this trial, including both a favorable safety profile as well as prolonged clinical responses, I believe that additional clinical development is warranted in this indication."
Exploring Additional Bavituximab Indications through Investigator-Sponsored Trials (IST):
A Phase I/II IST evaluating bavituximab in combination with sorafenib in up to 48 patients with advanced hepatocellular carcinoma (Liver Cancer).
A Phase Ib IST evaluating bavituximab in combination with carboplatin and pemetrexed in up to 25 patients with previously untreated Stage IV NSCLC.
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.
BAVITUXIMAB IMMUNOTHERAPY DEVELOPMENT PROGRAM
Through this program, Peregrine continues to explore the potential of combining bavituximab with other immunotherapies, experimental checkpoint inhibitors as well as vaccines. The company has initiated multiple proof-of-concept studies and presented encouraging preclinical data that could support new trials as well as serving as a basis for the ongoing Phase Ib immunotherapy combination trial. Presentation of data from the Phase Ib trial, as well as preclinical and proof-of concept studies are anticipated throughout fiscal year 2015.
During the quarter, the company announced the first clinical trial to emerge from this program with the initiation of an IST of bavituximab in combination with Bristol-Myers Squibb's ipilimumab (Yervoy®), for the treatment of advanced melanoma. This is an open-label, randomized, single-center Phase Ib trial in up to 24 patients. Data from preclinical studies evaluating the combination in a model of melanoma yielded an enhanced anti-tumor activity compared to ipilimumab alone.
During the quarter, data was presented at two Keystone Symposia and the Annual Meeting of the American Association for Cancer Research (AACR) from studies validating the immune-stimulatory mechanism of action of bavituximab. These presentations showed that the combination of a preclinical phosphatidylserine (PS)-targeting antibody and the immune checkpoint inhibitors anti-CTLA-4 or anti-PD-1 antibodies yielded superior anti-tumor immune responses in animal models of melanoma and colon cancer compared to anti-CTLA-4 and PD-1 antibodies alone. In a separate study, an equivalent antibody to bavituximab administered with stereotactic body radiation therapy demonstrated 100% improvement in survival and favorable tumor eradication in a model of non-small cell lung cancer compared to irradiation alone. In the antiviral area, researchers presented data showing that a PS-binding antibody inhibited HIV infection of cells by blocking viral receptors used by HIV for cell entry.
- - - - - - -[
• 4-2014 AACR'14: Peregrine's 3 posters http://tinyurl.com/k4fl8z6 - about Bavi as an “Upstream PS Checkpoint Inhibitor”; notably, “when combined with downstream immune checkpoint inhibitors such as anti-CTLA-4 and anti-PD-1, PS targeting mediates an improved protective tumor-specific immunity following tumor rechallenge”, and, “combination of bavituximab with the anti-PD-1 checkpoint blockade should synergistically induce potent long-lasting antitumor immunity.”]
• 3-2014: Keystone Conf./Alberta PS-Targeting/HIV Poster by PPHM’s Cyril Empig & Duke/Peregrine Co-Authors Haynes/Moody/etc http://tinyurl.com/m6kuqpr ]
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 had a strong fourth quarter and record year generating over $6 million in contract manufacturing revenue in the fourth quarter of FY 2014 and over $22 million in contract manufacturing revenue for the full FY 2014," said Paul Lytle, CFO of Peregrine. "We have also continued to strengthen our cash position over the past fiscal year to over $78 million as of June 30, 2014 as we continue to advance the Phase III SUNRISE trial and prepare for the potential commercialization of bavituximab. Under the company's hybrid business model, Avid is evaluating manufacturing options that would create new manufacturing capacity for the potential commercial launch of bavituximab while also providing Avid with available capacity for its continued growth."
FINANCIAL RESULTS
Total revenues for the fourth quarter of FY 2014 were $6,474,000, compared to $4,254,000 for the same quarter of the prior fiscal year. For FY 2014, total revenues were $22,401,000, compared to $21,683,000 for the prior year. The FY 2014 increase was primarily attributed to an increase in contract manufacturing revenue generated from Avid Bioservices.
Contract manufacturing revenues from Avid's clinical and commercial biomanufacturing services provided to its third-party clients were $22,294,000 for FY 2014 compared to $21,333,000 for FY 2013. Current contract manufacturing commitments from Avid's third-party customers are in excess of $26 million, covering services to be provided during FY 2015 and into FY 2016. Based on these current commitments, Peregrine expects contract manufacturing revenues for FY 2015 to be between $19 and $23 million. In addition to providing biomanufacturing services to its third-party clients, Avid will continue to support the potential commercialization of bavituximab.
Total costs and expenses in the fourth quarter of FY 2014 were $17,003,000, compared to $12,717,000 in the fourth quarter of FY 2013. For FY 2014, total costs and expenses were $58,107,000 compared to $50,035,000 for FY 2013. This increase was primarily attributable to current year increases in research and development expenses and selling, general and administrative expenses. The increase in research and development expenses for FY 2014 compared to FY 2013 was primarily attributable to expenses associated with the preparation and initiation of our Phase III SUNRISE trial combined with an increase in share-based compensation expense (non-cash). The increase in selling, general and administrative expenses for FY 2014 compared to FY 2013 was primarily attributable to increases in share-based compensation expense (non-cash), payroll and related expenses and corporate legal fees. For the fourth quarter FY 2014, research and development expenses were $8,813,000, compared to $5,835,000 for the fourth quarter of FY 2013, and for FY 2014 were $27,723,000, compared to $24,306,000 for FY 2013. For the fourth quarter FY 2014, selling, general and administrative expenses were $4,361,000, compared to $3,665,000 for the fourth quarter of FY 2013 and for FY 2014 were $17,274,000 compared to $13,134,000 for FY 2013.
Peregrine's consolidated net loss attributable to common stockholders was $10,649,000, or $0.06 per share, for the fourth quarter of FY 2014, compared to a net loss attributable to common stockholders of $8,449,000, or $0.06 per share, for the same quarter of the prior year. For FY 2014, net loss attributable to common stockholders was $35,763,000, or $0.22 per share, compared to $29,780,000, or $0.25 per share, for FY 2013.
Peregrine reported $77,490,000 in cash and cash equivalents as of April 30, 2014, compared to $35,204,000 at fiscal year ended April 30, 2013. As of June 30, 2014, the company reported $78,331,000 in cash and cash equivalents.
More detailed financial information and analysis may be found in Peregrine's Annual Report on Form 10-K, which will be filed with the Securities and Exchange Commission today. [ http://www.sec.gov/Archives/edgar/data/704562/000135448814003653/peregrine_10k-043014.htm ]
CONFERENCE CALL
Peregrine will host a conference call and webcast this afternoon, July 14, 2014, 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. A replay of the call will be available starting approximately two hours after the conclusion of the call through July 21, 2014 by calling (855) 859-2056, or (404) 537-3406 and using passcode 66161283. 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-Meyers Squibb.
PEREGRINE PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
Three Months Ended April 30, Twelve Months Ended April 30,
2014 2013 2014 2013
Unaudited Unaudited
REVENUES:
Contract manufacturing revenue $ 6,474,000 $ 4,176,000 $ 22,294,000 $ 21,333,000
License revenue - 78,000 107,000 350,000
Total revenues 6,474,000 4,254,000 22,401,000 21,683,000
COSTS AND EXPENSES:
Cost of contract manufacturing 3,829,000 3,217,000 13,110,000 12,595,000
Research and development 8,813,000 5,835,000 27,723,000 24,306,000
Selling, general and administrative 4,361,000 3,665,000 17,274,000 13,134,000
Total costs and expenses 17,003,000 12,717,000 58,107,000 50,035,000
LOSS FROM OPERATIONS (10,529,000 ) (8,463,000 ) (35,706,000 ) (28,352,000 )
OTHER INCOME (EXPENSE):
Interest and other income 281,000 15,000 349,000 322,000
Interest and other expense - (1,000 ) (5,000 ) (54,000 )
Loss on early extinguishment of debt - - - (1,696,000 )
NET LOSS $ (10,248,000 ) $ (8,449,000 ) $ (35,362,000 ) $ (29,780,000 )
COMPREHENSIVE LOSS $ (10,248,000 ) $ (8,449,000 ) $ (35,362,000 ) $ (29,780,000 )
Series E preferred stock accumulated dividends (401,000 )
(401,000 )
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS $ (10,649,000 ) $ (8,449,000 ) $ (35,763,000 ) $ (29,780,000 )
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:
Basic and Diluted 177,264,434 137,872,343 161,579,649 120,370,333
BASIC AND DILUTED LOSS PER COMMON SHARE $ (0.06 ) $ (0. 06 ) $ (0.22 ) $ (0. 25 )
PEREGRINE PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
AS OF APRIL 30, 2014 AND 2013
2014 2013
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 77,490,000 $ 35,204,000
Trade and other receivables, net 1,332,000 1,662,000
Inventories 5,530,000 4,339,000
Prepaid expenses and other current assets, net 1,419,000 709,000
Total current assets 85,771,000 41,914,000
PROPERTY AND EQUIPMENT:
Leasehold improvements 1,538,000 1,383,000
Laboratory equipment 5,646,000 5,441,000
Furniture, fixtures, office equipment and software 2,679,000 2,627,000
9,863,000 9,451,000
Less accumulated depreciation and amortization (7,416,000 ) (6,773,000 )
Property and equipment, net 2,447,000 2,678,000
Other assets 2,327,000 466,000
TOTAL ASSETS $ 90,545,000 $ 45,058,000
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 2,434,000 $ 2,821,000
Accrued clinical trial and related fees 4,433,000 930,000
Accrued payroll and related costs 3,837,000 3,582,000
Deferred revenue, current portion 5,241,000 4,171,000
Customer deposits 5,760,000 8,059,000
Other current liabilities 502,000 998,000
Total current liabilities 22,207,000 20,561,000
Deferred revenue, less current portion 292,000 292,000
Other long-term liabilities 347,000 445,000
Commitments and contingencies
STOCKHOLDERS' EQUITY:
Preferred stock - $.001 par value; authorized 5,000,000 shares; issued and outstanding - 775,000 and nil, respectively 1,000 -
Common stock - $.001 par value; authorized 325,000,000 shares; issued and outstanding - 178,871,164 and 143,768,946, respectively 179,000 143,000
Additional paid-in-capital 470,785,000 391,521,000
Accumulated deficit (403,266,000 ) (367,904,000
Total stockholders' equity 67,699,000 23,760,000
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 90,545,000 $ 45,058,000
Contact: Christopher Keenan, Peregrine Pharmaceuticals, Inc., (800) 987-8256 - info@peregrineinc.com
- - - - - - - - -
[ From 10-Q header: “As of July 7, 2014, there were 179,209,458 shares of issuer’s common stock
Contact: Christopher Keenan or Jay Carlson
Peregrine Pharmaceuticals, Inc. (800) 987-8256 info@peregrineinc.com
- - - - - - - - - - - - - - - - -
Latest 10K 4-30-14 iss. 7-14-14: http://tinyurl.com/mhva3k3 PR: http://tinyurl.com/o2e4a4g (Cash 4-30-14=$77.5mm 6-30-14=$78.3mm)
Latest 10Q 1-31-14 iss. 3-7-14 http://tinyurl.com/pxcjocw PR: http://tinyurl.com/kh9cnrg (Cash 1-31-13=$63.2mm, 2-15-14=$79.7mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
.
.
= = = = = = = = = = = = = = = = = = = = = = = = = = = =
Updated PPHM REVS-BY-QTR TABLE, now thru FY14/Q4 (fy/e 4-30-14), per the 4-30-14 10-K ( http://tinyurl.com/mhva3k3 ) issued 7-14-14. Deferred-Revs at 4-30-14, going fwd into FY’15/Q1 (q/e 7-31-14), total $5.2mm, up from the $4.3mm of Deferred-Revs at 1-31-14 that drove into FY’14/Q4.
• Total Revs since May’06: ($102.5mm/Avid + $24.1mm/Govt + $2.1mm/Lic.) = $128.7mm
• Avid’s Gross-Profit over last 4 qtrs: $9.2mm on revs of $22.3mm (GM% = 41%)
==> Recall, Avid Rev$ 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%
*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
Totals: 102468 24149 2087 128704 <=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
.
= = = = = = =
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)
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.”
.
- - - - - - - - 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)
= = = = = = = = = = = =
“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
= = = = = = = = = = 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 7-17-2014:
http://www.peregrineinc.com/images/stories/pdfs/july-2014_corp_fact_sheet.pdf
= = = = = = = = = = = = = = =
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
- - - - - - - -
Bavi MOA: 4-min Video on Bavi’s Immunotherapeutic Moa added to PeregineInc.com on 1-13-2014: http://tinyurl.com/mbd3kta
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
. . .CRI launches “Answer to Cancer” (cancer immunotherapy) website http://www.theanswertocancer.org
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
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
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