9-9-13 Qtly CC Transcript, PR (Financials/Devs Q1FY14/qe7-31-13), and the updated Avid Revenues History Table By Quarter (May’06-Current)…
This large post has 3 sections:
I. 9-9-13 Q1/FY14 Qtly. Earnings Conf. Call TRANSCRIPT (q/e 7-31-13)
II. 9-9-13 PPHM Press Release: Q1/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/olhau2g ], with numerous corrections made. )))
Link to webcast replay: http://ir.peregrineinc.com/eventdetail.cfm?eventid=134276
FULL TRANSCRIPT…
9-9-2013 Q1 FY’14 Earnings Conf. Call (q/e 7-31-13)
WELCOME & FWD-LOOKING STATEMENTS: Jay Carlson (IR) http://www.peregrineinc.com
Speakers: Steve King, Jeff Hutchins, Joe Shan, Paul Lytle; Q&A session.
CEO Steve King – OPENING COMMENTS:
This quarter, we were very active on multiple fronts including research, clinical, and manufacturing. Our key focus is to advance the bavituximab clinical program, building on recent promising clinical data as well as the exciting data showing that bavituximab primarily works through an immune-stimulating mechanism of action.
Most of this data is set for print publishing in October, but is already available online through the publisher's website, prompting our news release today [9-9-13: “Data Supporting Bavituximab's Immunotherapy MOA Published in the Peer-Reviewed AACR Journal Cancer Immunology Research” http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=789492 ]. These results have spurred new preclinical research activities that include exploring exciting new combinations and different ways to use bavituximab. In particular, the new mechanism data has sparked interest from both academic & industry collaborators to explore combinations with other immunotherapy agents not previously considered. Dr. Hutchins will talk more about our ongoing efforts in this area, including highlights from his recent presentation at the Immunotherapy Congress on August [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 ] during his discussion later in the call.
Over the last few months, we have been building on the excitement created by the immunotherapy mechanism data and have been actively engaging scientists and key opinion leaders in the field of immunology, with the goal of engaging their expertise as we advance the bavituximab program. We have been extremely pleased as to how these data have been received and the enthusiasm exhibited from the potential of bavituximab. We are looking forward to continuing these activities and supplementing these discussions with preclinical data for ongoing studies expected to come out in the next few months.
In addition to the immunotherapy research, there has been significant interest in the results presented at ASCO showing an 84% tumor response rate in HER2-negative breast cancer patients [6-3-13: ASCO’13/interim data, n=14: ORR=85%, 2 CR’s (15%) http://tinyurl.com/kq3uv4e ], highlighting the potential of bavituximab in this difficult-to-treat indication. Of course, our key company goal remains initiating the Phase III 2nd-Line NSCLC study, which we have named the ”SUNRISE” trial (Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III Lung Cancer Study), by year end - lots of activities on the clinical front that Joe Shan will cover during his prepared remarks.
While moving forward on the science front, we have continued to see strong performance from our contract mfg. business, Avid Bioservices, with another good revenue quarter. All of this while strengthening our cash position, which allows us to advance our programs toward upcoming milestones, while we continue to engage in active partnering discussions for both our bavituximab and Cotara programs. Paul will talk about these developments during his prepared remarks. With that, I'll now turn the call over to Dr. Jeff Hutchins.
JEFF HUTCHINS (VP/Preclinical Research):
This has been a busy & exciting time for the preclinical group as bavituximab's new mechanistic findings have enhanced the way we are thinking about the future development of this novel drug candidate. From a preclinical perspective, our mandate was to chart a translational path that would best leverage these results within the most efficient timeframe and yielding definitive results for consideration in further clinical development.
Beginning in June, we executed the first studies within an intensive preclinical program that utilizes a team comprised of Peregrine & academic scientists. These initial studies could provide preclinical proof-of-concept support for the clinical development of bavituximab in combination with other immunotherapy drugs, much in the same way as we have seen with the complementary immunostimulatory combination with docetaxel. These ongoing studies are expected to read out over the next several months, with potential to generate the necessary data to further our clinical investigations.
In addition, we are leveraging our ongoing IST’s to provide translational clinical data reflective of the preclinical findings. For example, as part of our Liver IST [UTSW/Dr.Yopp: http://clinicaltrials.gov/ct2/show/NCT01264705 ], we are collecting patient tissue samples with the goal of assessing changes in cytokines that could help us understand bavituximab's moa in patients.
Over the last few months, I have had chance to present these data to scientific leaders, investigators, and most recently, to the immunotherapy industry leaders at Cambridge Health Institute's Immunotherapy Congress in August [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 ]. The interest & response from these interactions has been overwhelmingly positive, opening up many new collaborative opportunities that we will explore. We have now begun to appropriately insert ourselves into the very exciting and topical immunotherapy discussion. As such, you can expect to see us at scientific venues in the coming months as we continue to share these exciting data to the scientific community.
In parallel with these efforts, our academic collaborators have been actively pursuing a publication strategy to showcase these data. Their success has been realized with the publication of a manuscript in the AACR's peer-reviewed journal, Cancer Immunology Research [9-9-13: “Data Supporting Bavituximab's Immunotherapy MOA Published in the Peer-Reviewed AACR Journal Cancer Immunology Research” http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=789492 ]. This journal's aim is to report major advances in cancer immunology that span multiple disciplines within the oncology research community. Overall, these data have already garnered a great deal of interest in the immunology community. We look forward to updating you on potential developments in that area, apprising you of preclinical development decisions, and expanding the immunology discussion in the coming months.
JOE SHAN (VP/Clin.&Reg. Affairs) – CLINICAL TRIALS:
The clinical activities during the quarter focused on preparations for the start of our pivotal Phase III trial in NSCLC and supporting the preclinical proof-of-concept program that Jeff just outlined for you. The Phase III trial is named ”SUNRISE”, an acronym which stands for “Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III Lung Cancer Study”. SUNRISE is a randomized, double-blind, placebo-ctl’d trial evaluating bavituximab+docetaxel, vs. docetaxel+placebo in approx. 600 patients at over 100 clinical sites worldwide. These sites will enroll patients with Stage IIIb or IV, non-squamous, NSCLC who have progressed after std. front-line treatment. Patients will be randomized into 1 of 2 treatment arms. One treatment arm will receive up to 6 21-day cycles of docetaxel at 75/mg in combination with 3mg/kg of bavituximab weekly until progression or toxicity. The other treatment arm will also receive the same docetaxel regimen but in combination with placebo, weekly until progression or toxicity. The primary endpoint of the trial will be overall survival. Secondary endpoints include PFS and ORR based on immune-related response criteria, given our current understanding of the action mechanism. In addition, we plan to collect exploratory biomarker samples that may support & enhance our understanding of bavituximab's immune MOA in the clinic. There's increasing rationale for combining bavituximab and docetaxel as not only as a std. treatment for 2nd-Line NSCLC that increases PS - docetaxel also decreases immunosuppressive cells known as myeloid derived suppressor cells, which could complement bavituximab's immune mechanism, as Jeff described earlier.
SUNRISE will also have an independent data monitoring committee that will assess safety on an ongoing basis, as well as the planned interim & final efficacy analysis. Over the coming weeks, our team will be working towards selecting investigators, obtaining regulatory approvals with global health authorities, ethics committees and clinical trial sites and finalizing necessary operational details to initiate the trial by year end.
As Steve mentioned, we are making the necessary additions to both internal headcount as well as outsourcing partners to ensure a well-executed program. While our immediate clinical focus is on executing the SUNRISE trial, we are continuing to work closely with the preclinical group as the potential immunotherapeutic applications of bavituximab are both exciting & numerous. We anticipate some of the ongoing ISTs may begin to yield some immune correlative data over the coming months and look forward to providing updates as soon as they become available.
CFO Paul Lytle:
Let me spend the next few moments to cover a few financial highlights and our related financial goals. As Joe just emphasized, our clinical & regulatory teams are extremely busy with advancing bavituximab into Phase III development for the treatment of 2nd-Line lung cancer, representing a major market opportunity. And to achieve these goals, we are carefully managing our resources and our various sources of capital, including the capital generated from our contract mfg. business. During the recent qtr, our contract mfg. business, Avid Bioservices, generated just over $4.5mm in contract mfg. revenue. This is a solid start to FY'14, and we expect contract mfg. revenue for the entire FY'14 to be $18-$22 million based on current commitments. Along with the work being done for our 3rd-party clients, Avid continues to be instrumental in providing drug supply for the bavituximab Phase III trial while also preparing bavituximab for potential commercialization.
Now turning to our cash position. We continued to maintain a balanced financial approach, ending the qtr. with $41.6mm in cash compared to $35.2mm in cash at FYE April 30, 2013. This provides us sufficient capital to fund our operations through at least Q1/FY’15 based on our current financial projections, giving us the needed flexibility to initiate the upcoming Phase III trial and 2nd-Line lung cancer while strengthening our position as we evaluate other opportunities, including ongoing partnering discussions. We look forward to keeping you updated on our progress, and we will now open the call up for your questions.
Q&A: [14:10 mark]
1. Joe Pantginis – Roth Capital Partners: [ http://www.roth.com & https://roth2.bluematrix.com/docs/pdf/BLUE.pdf ]
JP: First, with regard to your stated goals of starting the SUNRISE study before the end of the year, and then you also say that you're partnering discussions remain active, how tied together or not are these 2 different goals? Do you require a partner to be in place prior to the start of the study? Or can you start the study independently?
SK: I think we've put ourselves in position where it's our intention to go ahead and be able to start the clinical study and to, in fact, complete the clinical study, if necessary, on our own. Our fore-stated goal is to continue the partnering discussions. Obviously, it is a driver for many of the partners to potentially be involved in the Phase III trial, in the operation of the Phase III trial, so it becomes a positive from a partnering standpoint. But we also recognize that we want to be able to control what we can control, and right now, we can control getting that trial up and running and executing it – I think we have a good solid team in place, brought onboard some individuals with significant experience in running Phase III clinical trials; of course, a lot of experience on the regulatory side as well. So I think we're in a good position to execute on the clinical study, continue those partnering discussions and hopefully, under the right deal terms, be able to bring those 2 things together.
JP: I want to have a little bit of an immunotherapy discussion regarding the SUNRISE trial and especially after your growing database in today's publication in the AACR journal. The way Joe described the study is that you're going to be giving bavi in these patients until progression or toxicity. Is that what I heard correctly?
Joe Shan: Yes, that's pretty standard. So basically, it's a maintenance phase after the patients receive the maximum cycles of chemotherapy.
JP: So, the nuance that I wanted to bring up here is, if you were to consider the guidance that the FDA had previously written regarding immunotherapy approaches, regarding progressive disease and also, clinical experience for drugs like YERVOY, for example, where you would see potential progression followed by regression. I was just wondering, are you looking to have some sort of monitoring of or education of the physicians based on these new immunological data that you're finding here, where you might see progression in patients, but that you'd leave it enough time for the immune system to act?
Joe Shan: Actually, yes, we have incorporated that feature into the protocol. We will be utilizing the immune-related response criteria and building inexpensive training. We'll also have some central radiology interpretation as well.
JP: Would you basically tell physicians almost directly, you're almost paraphrasing what's in the FDA guidance for the industry to say, ‘don't necessarily rush to take your patients off therapy, because of the delayed separation of Kaplan-Meier curves’. That's the nuance I'm sort of looking for.
Joe Shan: Yes, that's describing the criteria that I mentioned.
Joseph Pantginis - Roth Capital Partners, LLC, Research Division
JP: As part of the Phase III, are you planning to have an interim analysis?
Joe Shan: Yes, we are.
JP: Are you disclosing at the time point of enrollment or events?
Joe Shan: Not at this point.
2. George Zavoico (MLV): [ 2-8-10 coverage init: http://tinyurl.com/yech7gz ]
GZ: A couple of questions about SUNRISE. Are you going to be using a lot of the same sites that you used for the Phase IIb trial to help accelerate getting the trial going?
Joe Shan: Yes, absolutely. We're looking at leveraging experience. Yes, I think some of the sites will be able to come up and get activated a little bit faster because they have prior experience. Some other sites might have other competing trials, but that's definitely in the strategy, leveraging, yes.
GZ: In that regard, can you provide any guidance as to how long you project the enrollment may take and how long the whole trial may take?
Joe Shan: I think we've stated previously that our goal is to get a trial that can be done and enrolled in 2 years' time. So, we are monitoring that and selecting the best sites that we can to achieve not only that enrollment rate but also get the highest quality possible. And kind of to the other question, but, Joe, making sure we get as many sites that are really familiar with immunotherapy. I mean, that's important, too.
GZ: Can you guide as to how much you might expect the trial to cost?
Paul Lytle: Yes. Generally, in Phase III trials, George, it’s about $100,000 a patient. So it's 600 patients, you're looking at around $60mm. That being said, these costs are going to be spread over a pretty long period of time with the 2-year enrollment, probably a 1-year follow-up. And then you even have longer periods of time in terms of other costs that come out of the trial. So those are probably going to be spread out over 3.5, 4 years' period.
GZ: In that regard, Paul, you mentioned a sort of balanced financial approach - you've clearly used the ATM. Are you considering as well, last year, you tried a debt offering, which unfortunately didn't work because of what happened with the mixed-up arms of the trial. Avid is clearly a revenue-generating arm. Maybe you could leverage some debt off of that?
Paul Lytle: Yes. our goal has always been to look at non-dilutive capital for the company. Looking at a term loan or some type of leverage debt makes a lot of sense, assuming it doesn't have to be paid back in a relatively short period of time. So longer payment terms, maybe something that get you past kind of the Phase III readout. Obviously, leveraging Avid is key. So I think looking at those type of options, obviously revenue growth, looking at potentially new services that Avid could offer, expanding that revenue offerings and potential is also going to be a key driver for the company. And then obviously, we go back to the equity markets when we need to, to maintain a balanced financial approach so that we can meet our commitments and meet our timelines based on what we've laid out.
GZ: One last question with regard to SUNRISE. It looks like essentially, apart from perhaps looking at new biomarkers, how different, other than, of course, the number of sites and the number of patients, is it going to be from the Phase IIb trial? Any other differences?
Joe Shan: It's very similar. And we're only looking at one dose level of bavituximab, and that's really the only difference. And then, of course, the sample size. By design, the Phase III is a confirmatory statistical exercise, so I think that gives us the best chance of replicating on what we think we saw in the clinical data off from the Phase II in a larger patient experience.
GZ: You mentioned in your prepared remarks, that you're going to be looking at the cytokines and tumor samples. Some of the other markers you looked at that were published today look very interesting. Are you going to be able to do that as well, for example, confirming the macrophage phenotype switch?
Jeff Hutchins: George, that's certainly our goal. We're looking at the quality of those samples first, but certainly the goal is to look at MDSC levels, macrophage, whether it's an M1 or an M2 switch during time. And it is quite nice that we do have before-treatment and after-treatment samples. So we feel like we're well positioned to make those kind of measurements.
GZ: So there'll essentially be 2 biopsy samples, before and after treatment?
Jeff Hutchins: If it's regarding the SUNRISE, no.
Joe Shan: In SUNRISE, they're going to be exploratory, and they're not going to be tissue-based necessarily.
SK: George, we’ve got of a lot of things going on with our clinical studies, so we have a number of ISTs that have been ongoing. I think that Jeff was referring to is the fact that we have been collecting tissue biopsy samples from some of those [IST] studies like liver cancer study or rectal cancer study that's been built into the trial as well. So, those are things that we can do now. Those tissue samples have been collected, and based on the appropriateness, we can now look for some of these phenotype changes and macrophages and other cell types associated with bavituximab therapy. As far as the kind of go-forward plan, one of our other stated goals is to really potentially look at some combinations with other immunotherapies. Of course, in those clinical trials, we would want to build in the ability to collect tissue samples to further validate in the clinical setting what we've seen so nicely in the preclinical study that was published today. But as far as SUNRISE trial, we obviously don't want to add a lot of complexities into our Phase III, and tissue biopsies certainly fall under that category. So, we’ll be looking at things like potentially peripheral blood and things that are easy to collect and look at from a clinical setting. So, taken altogether, we've got a lot of opportunities to generate data over the coming months that, will, again, further help corroborate what we're seeing in a clinical setting with what we saw in the preclinical setting but also really helps guide the program into some exciting new combinations.
3. Charles Duncan – Piper Jaffray [http://www.piperjaffray.com – 3-5-13 Initiates PPHM: http://tinyurl.com/bxhntk3 ]
CD: First of all, congratulations on a nice article in Cancer Immunology today. Many of my questions were asked, but perhaps I could ask a few more details on SUNRISE. With regard to statistics, I'm wondering what you're assuming in terms of kind of a clinical benefit that kind of drives the size of the trial? If you could help us out with those powering assumptions.
Joe Shan: I think we've guided in the past that we haven't released the exact hazard ratio under powering for, but we powered it for about a 2 months' difference in MOS. It's pretty typical, and we're talking in the hazard ratio range of between .75 and...
CD: You said 2 months, Joe?
Joe Shan: 2 months, yes, for median point estimate.
CD: I know you're not really disclosing the details around the interim analysis, but can I assume that to occur at roughly 50-60% of the events. And also, do you accommodate an adaptive design? Is there any way to change the sizing of the trial prospectively?
Joe Shan: The way the trial is designed and agreed upon by the FDA is not adaptive in nature in terms of sample size re-estimation. It's a pretty standard, classic, pivotal sample trial design, I think something the agency is very familiar and comfortable with. Your assumption about the interim analysis is pretty close, so...
CD: Also, in terms of the % of patients, I guess one of the risks that I've seen in some other lung cancer trials is % of patients here in the States vs. other areas of the world and being able to control whether or not a patient really is at Stage IIIb or IV. I know you've given some thought to that. What are the % that you'd like to see in terms of the # of patients? And then how do you control or how do you plan to control for patients actually coming in at a later stage of lung cancer?
Joe Shan: Without going into too much detail, I mean, there's several design features, including the way we stratify our randomization to ensure some balance. Obviously, it's a large enough study that a lot of prognostic variables should balance out, like age or gender, for example. There are other features both from the randomization standpoint, as well as we can control capping in the amount of patients from any particular country or region. and that's something that we have some control over. So again, earlier, our goal is 2-year enrollment. Of course, we're going to see how that goes. If there's a particular region that's enrolling much faster than others, that's something we'll evaluate along the way. So yes, there's several features that we've incorporated early into the trial design and execution plan.
CD: My final question is on collaboration. I realized that, as Paul said, you can start and possibly finish this trial with the capital resources you have. But it seems to me that there is potential for collaboration whose interest might have increased since all the immunotherapy focus in ASCO. Has there been an increase in bavituximab since then? And what is the feedback? And then finally, is Cotara still on the table as a potential source of collaboration?
SK: Yes, Cotara's essentially on the table as a good collaborative discussion point with potential partners so that certainly, there is another source of partnering activity. I would characterize it as a tremendous amount of interest with the new immunotherapy mechanism data. I think there's a lot of collaboration interest with companies that are actually very active in the immunotherapy space because of the nature of our upstream target, the fact that we're going after really a primary endpoint of control in the immune response to the tumor, it really creates a lot of opportunities with these downstream effectors, and of course, PD-1, PDL-1 and CTLA-4 were certainly hot topics at ASCO. But there are a lot of other opportunities with downstream inhibitors that we think are a great fit with bavituximab. So, yes, I think it just opens up a whole new world of collaboration opportunities well outside just the kind of where we've been historically with chemotherapy and other types of treatment, like radiation, and really opening up a whole bunch of new doors that are really a very intense area of research right now.
MR. KING’S CLOSING COMMENTS:
As you have heard, this is a busy time at Peregrine, with a lot of exciting and promising activities underway. Our goal over the next few months will be to continue to actively engage multiple audiences, the scientific, clinical and investment communities as well as potential partners. The recent bavi immunotherapy data has transformed our thinking about the program, opening up an abundant number of partnering and collaborative opportunities. We look forward to updating you on these activities as we continue preparations to initiate the SUNRISE trial and add value to the company and our shareholders. Thank you.
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9-9-13 PR: Peregrine Pharmaceuticals Reports Q1/FY2014 Financial Results and Recent Developments
Bavituximab Pivotal Phase III Lung Cancer Trial Named "SUNRISE" on Track for Initiation by Calendar Year-End
Bavituximab Pre-Clinical Proof-Of Concept Studies Underway to Support Potential Immunotherapy Combination Trial
Avid Bioservices Quarterly Revenue Tops $4.5 Million
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=789648
TUSTIN, 9/9/13: Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a biopharmaceutical company developing first-in-class monoclonal antibodies focused on the treatment and diagnosis of cancer, today announced financial results for the first quarter of fiscal year (FY) 2014 ended July 31, 2013 and provided an update on its advancing clinical pipeline and other corporate developments.
"We continue to steadily progress the bavituximab clinical program as we prepare to initiate a global Phase III trial by year-end in second-line non-small cell lung cancer. In addition to Phase III preparations, our researchers and external collaborators have undertaken a flurry of preclinical experimentation that will help guide exciting new combinations and therapeutic areas for bavituximab. This activity was spurred on by recent data showing that bavituximab works by harnessing the body's natural immune system to fight cancer," said Steven W. King, President and CEO of Peregrine. "Our preclinical development plan is designed to simultaneously look at new indications and therapeutic regimens including new combinations with other immunotherapy agents. Because bavituximab acts on a primary immune system checkpoint, there are an abundance of possible immunotherapy combinations with agents working on further downstream targets. We expect results from these studies over the coming months as we move toward advancing new combinations into the clinic. We look forward to a number of updates on the program as we move through the rest of the year."
BAVITUXIMAB ONCOLOGY PROGRAM HIGHLIGHTS
Lead Indication in Second-Line Non-Small Cell Lung Cancer:
• Continued to plan for the initiation of the SUNRISE Trial (Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III Lung Cancer Study). ?SUNRISE is a Phase III, global, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety, tolerability and efficacy of bavituximab in patients with second-line non-small cell lung cancer (NSCLC). Specifically, the trial will evaluate bavituximab plus docetaxel versus docetaxel plus placebo in approximately 600 patients at clinical sites worldwide. Patients with Stage IIIb/IV non-squamous, NSCLC who have progressed after standard front-line treatment are eligible for enrollment. Patients will be randomized into 1 of 2 treatment arms. All patients will receive 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 of toxicity. The primary endpoint of the trial will be overall survival. The company anticipates initiating the SUNRISE trial by the end of this calendar year.
Other Oncology Indications:
The company is exploring the potential of bavituximab through a number of investigator-sponsored trials (IST) including:
• A Phase I IST evaluating bavituximab in combination with paclitaxel in up to 14 patients with HER2-negative metastatic breast cancer. All patients have been enrolled in this trial with interim data on 13 evaluable patients 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 measured in accordance with RECIST criteria.
• A Phase I/II IST evaluating bavituximab in combination with sorafenib in up to 48 patients with advanced hepatocellular carcinoma (liver cancer). The Phase I portion of the trial has completed patient enrollment with enrollment in the Phase II portion of the trial ongoing.
• A Phase Ib IST evaluating bavituximab in combination with carboplatin and pemetrexed in up to 25 patients with previously untreated Stage IV NSCLC. This trial continues to enroll and dose patients.
• 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. This trial continues to enroll and dose patients.
BAVITUXIMAB IMMUNOTHERAPY DEVELOPMENT PROGRAM
This morning, Peregrine announced the publication of a data supporting the immune-stimulatory mechanism of action of phosphatidylserine (PS)-targeting antibodies, such as the company's lead drug candidate bavituximab in the American Association for Cancer Research (AACR) peer-reviewed journal, Cancer Immunology Research. In the manuscript titled: "Phosphatidylserine-targeting antibody induces M1 macrophage polarization and promotes myeloid derived suppressor cell differentiation," researchers demonstrated that exposed PS plays a major role in the inhibition of pro-inflammatory cellular and cytokine responses in tumors and that PS-targeting antibodies override this primary upstream immune checkpoint, activating multiple downstream immunostimulatory effects, including the conversion of myeloid derived suppressor cells into tumor immunity promoting M1 macrophages and the generation of tumor killing cytotoxic T-cells.
Peregrine is exploring the potential to combine bavituximab with other immunotherapies such as anti-CTLA-4, anti-PD-1, and anti-PD-L1 antibodies and has initiated several ongoing pre-clinical proof-of-concept studies to support an immunotherapy combination trial with bavituximab.
IMAGING PROGRAM HIGHLIGHTS
PS-Targeting Molecular Imaging Program
Peregrine continues to enroll and dose patients in an open-label, single-center trial of its experimental PS-targeting molecular imaging candidate, 124I-PGN650, in patients with various solid tumor types. The primary goal of the trial is to estimate radiation dosimetry in critical and non-critical organs. Secondary objectives of the trial are tumor imaging and safety.
FINANCIAL RESULTS
"Our wholly-owned contract manufacturing subsidiary, Avid Bioservices, continue to perform well, generating over $4.5 million in contract manufacturing revenue in the first quarter of FY 2014, a non-dilutive source of capital. With our current backlog for services, we expect contract manufacturing revenue for the entire FY 2014 to be between $18 and $22 million," said Paul Lytle, CFO of Peregrine. "We also remained focused on seeking potential partners for our bavituximab program while successfully maintaining a balanced financial approach that provides us much flexibility in our ongoing partnering discussions."
Total revenues for the first quarter of FY 2014 were $4,688,000, compared to $4,251,000 for the same quarter of the prior fiscal year. The increase was primarily attributed to an increase in contract manufacturing revenue generated from Avid Bioservices due to an increase in the number of completed manufacturing runs.
Contract manufacturing revenues from Avid's clinical and commercial biomanufacturing services provided to its third-party clients for the first quarter FY 2014 were $4,581,000, compared to $4,135,000 for the same quarter of the prior fiscal year. Peregrine expects contract manufacturing revenues for FY 2014 to be between $18 million and $22 million. In addition to providing biomanufacturing services to its third-party clients, Avid will continue to utilize available capacity and resources to continue its preparation for later stage clinical development and potential commercialization of bavituximab and Cotara.
Total costs and expenses in the first quarter of FY 2014 were $12,308,000, compared to $11,922,000 in the first quarter of FY 2013. This increase was attributable to the current year three-month period increase in the cost of contract manufacturing associated with higher revenues in the current quarter combined with an increase in selling, general and administrative expenses. The increase in selling, general and administrative expenses for the first quarter FY 2014 compared to the first quarter of FY 2013 was primarily attributable to increases in share-based compensation expense, payroll and related expenses, and corporate legal fees.
Peregrine's consolidated net loss was $7,600,000, or $0.05 per share, for the first quarter of FY 2014, compared to a net loss of $7,664,000, or $0.07 per share, for the same quarter of the prior year.
Peregrine reported $41,600,000 in cash and cash equivalents as of July 31, 2013, compared to $35,204,000 at fiscal year ended April 30, 2013.
More detailed financial information and analysis may be found in Peregrine's Annual Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today. [ http://www.sec.gov/Archives/edgar/data/704562/000101968713003495/peregrine_10q-073113.htm ]
Conference Call
Peregrine will host a conference call and webcast this afternoon, September 9, 2013, 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 September 16, 2013 by calling (855) 859-2056, or (404) 537-3406 and using passcode 37006614. 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 portfolio of innovative monoclonal antibodies in clinical trials focused on the treatment and diagnosis of cancer. The company is pursuing multiple clinical programs in cancer with its lead immunotherapy candidate bavituximab and novel brain cancer agent Cotara®. 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*
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
THREE MONTHS ENDED
July 31, 2013 July 31, 2012
Unaudited Unaudited
REVENUES:
Contract manufacturing revenue $ 4,581,000 $ 4,135,000
License revenue 107,000 116,000
Total revenues 4,688,000 4,251,000
COSTS AND EXPENSES:
Cost of contract manufacturing 2,670,000 2,024,000
Research and development 5,304,000 6,981,000
Selling, general and administrative 4,334,000 2,917,000
Total costs and expenses 12,308,000 11,922,000
LOSS FROM OPERATIONS (7,620,000 ) (7,671,000 )
OTHER INCOME (EXPENSE):
Interest and other income 21,000 8,000
Interest and other expense (1,000 ) (1,000 )
NET LOSS $ (7,600,000 ) $ (7,664,000 )
COMPREHENSIVE LOSS $ (7,600,000 ) $ (7,664,000 )
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING
Basic and diluted 149,393,630 103,283,937
ASIC AND DILUTED LOSS PER COMMON SHARE $ (0.05 ) $ (0.07 )
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
JULY 31, 2013 APRIL 30, 2013 Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 41,600,000 $ 35,204,000
Trade and other receivables, net 2,272,000 1,662,000
Inventories 5,679,000 4,339,000
Prepaid expenses and other current assets, net 635,000 709,000
Total current assets 50,186,000 41,914,000
Property and equipment, net 2,448,000 2,678,000
Other assets 689,000 466,000
TOTAL ASSETS $ 53,323,000 $ 45,058,000
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 2,160,000 $ 2,821,000
Accrued clinical trial and related fees 608,000 930,000
Accrued payroll and related costs 3,271,000 3,582,000
Deferred revenue, current portion 4,164,000 4,171,000
Customer deposits 8,528,000 8,059,000
Other current liabilities 1,335,000 998,000
Total current liabilities 20,066,000 20,561,000
Deferred revenue, less current portion 292,000 292,000
Other long-term liabilities 422,000 445,000
Commitments and contingencies
STOCKHOLDERS' EQUITY:
Preferred stock-$0.001 par value; authorized 5,000,000 shares; non-voting; nil shares outstanding - -
Common stock-$0.001 par value; authorized 325,000,000 shares; outstanding - 153,506,811 and 143,768,946, respectively
153,000 143,000
Additional paid-in capital 407,894,000 391,521,000
Accumulated deficit (375,504,000 ) (367,904,000 )
Total stockholders' equity 32,543,000 23,760,000
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 53,323,000 $ 45,058,000
Contact: Christopher Keenan or Jay Carlson
Peregrine Pharmaceuticals, Inc. (800) 987-8256 info@peregrineinc.com
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Latest 10K 4-30-13 iss. 7-11-13: http://tinyurl.com/p58jcbw PR: http://tinyurl.com/khpokw6 (Cash 4-30-13=$35.2, 6-30-13=$42.6mm)
Latest 10Q 7-31-13 iss. 9-9-13 http://tinyurl.com/lnvaw3w PR: http://tinyurl.com/q3zooj6 (Cash 7-31-13 $41.6mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
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= = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
Updated PPHM REVS-BY-QTR TABLE, now thru FY14/Q1 (q/e 7-31-13), per the 7-31-13 10-Q ( http://tinyurl.com/lnvaw3w ) issued 9-9-13. Deferred-Revs at 7-31-13, going fwd into FY’14/Q2 (q/e 10-31-13), total $4.16mm, down from the $4.17mm of Deferred-Revs at 4-30-13 that drove into FY’14/Q1.
• Total Revs since May’06: ($84.8mm/Avid + $24.1mm/Govt + $2.1mm/Lic.) = $111.0mm
==> Recall, Avid Rev$ 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%
*Avid Net-Profit (ie, incl. Selling, G&A) not split out from PPHM-Corp. in the financials.
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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
Totals: 84755 24149 2087 110991 <=since5/1/2006
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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
...Total Gov’t Revs from 7-2008 inception thru FY11Q4(Apr’11): $24.15mm
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AVID “Total Services”:
AVID OUTPUT$ 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.”
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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
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= = = = = = =
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)
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
*The 10-Q’s define OPER.BURN as, ”Net cash used in operating activities before chgs. in operating assets & liabilities”.
The 7-21-2001 10Q explains OP.BURN very nicely:
“RESULTS OF OPERATIONS. Before we discuss the Company's total expenses (cash & non-cash expenses), we would like to discuss the Company's operational burn rate (cash expenses used in operations, net of interest and other income) for q/e July 31, 2001 compared to the same period in the prior year. The operational burn rate is calculated by taking the net income (loss) from operations and subtracting all non-cash items, such as the recognition of deferred license revenue, depreciation and amortization and stock-based compensation expense.”
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- - - - - - - - PPHM’s Fiscal Qtr’s (FY runs May – April):
FY’10-Q3 = q/e 1-31-10 – rep. 3-11-10 Thu (B4 mkt)
FY’10-Q4 = q/e 4-30-10 – rep. 7-14-10 Wed (after mkt)
FY’11-Q1 = q/e 7-31-10 – rep. 9-9-10 Thu (after mkt)
FY’11-Q2 = q/e 10-31-10 – rep. 12-9-10 Thu (after mkt)
FY’11-Q3 = q/e 1-31-10 – rep. 3-11-11 Fri (after mkt)
FY’11-Q4 = q/e 4-30-11 – rep. 7-14-11 Thu (after mkt)
FY’12-Q1 = q/e 7-31-11 – rep. 9-9-11 Fri (B4 mkt)
FY’12-Q2 = q/e 10-31-11 – rep. 12-12-11 Mon (after mkt)
FY’12-Q3 = q/e 1-31-12 – rep. 3-9-12 Fri (after mkt)
FY’12-Q4 = q/e 4-30-12 – rep. 7-16-12 Mon (after mkt)
FY’13-Q1 = q/e 7-31-12 – rep. 9-10-12 Mon (B4 mkt)
FY’13-Q2 = q/e 10-31-12 – rep. 12-10-12 Mon (after mkt)
FY’13-Q3 = q/e 1-31-13 – rep. 3-12-13 Tue (after mkt)
FY’13-Q4 = q/e 4-30-13 – rep. 7-11-13 Thu (after mkt)
FY’14-Q1 = q/e 7-31-13 – rep. 9-9-13 Mon (after mkt)
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“Going Concern” statement ELIMINATED from 4-30-13 10-K issued 7-11-2013…
2012: 4-30-12 10-K iss. 7-16-12 http://tinyurl.com/79o57b2
Pg.68: “As more fully described in Note 2, the Company’s recurring losses from operations and recurring negative cash flows from operating activities raise substantial doubt about its ability to continue as a going concern.”
2013: 4-30-13 10-K iss. 7-11-13 http://tinyurl.com/p58jcbw
==> ((((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
(from 7-11-13 PR: http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=776569 )
= = = = = = = = = = Also, a quick look at #Employees per 4-30-13 10K…
2011: 4-30-11 10-K: "As of 4-30-11, we employed 154 full-time emps & 2 part-time emps”
2012: 4-30-12 10-K: "As of 4-30-12, we employed 172 full-time emps & 2 part-time emps."
2013: 4-30-13 10-K: "As of 4-30-13, we employed 182 full-time emps & 5 part-time emps."
= = = = = = = = = = = = = = = = = = http://www.peregrineinc.com
Peregrine’s Corp. Fact Sheet updated 9-10-13:
http://www.peregrineinc.com/images/stories/pdfs/sept_2013_fact_sheet.pdf
From 9-10-13 Factsheet, incl. info. about upcoming Ph.III 2nd-line NSCLC trial, “SUNRISE”:
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