Wednesday, September 10, 2014 2:39:33 PM
9-9-14 Qtly CC-Transcript, PR(Fins/Devs Q1FY15/qe7-31-14), updated Avid Revenues History Table By Quarter…
=> Total Revs May06-Jul14: $108.0mm/Avid + $24.1mm/Govt + $2.1mm/Lic. = $134.2mm
This large post has 3 sections:
I. 9-9-14 Q1/FY15 Qtly. Earnings Conf. Call TRANSCRIPT (q/e 7-31-14)
II. 9-9-14 PPHM Press Release: Q1/FY15 Earnings & Developments
III. Updated Table of Avid Revenues By Quarter (May’06-Current)
…Recall: Peregrine’s FY runs May-Apr, so FY’15 = May’14-Apr’15.
((( Orig. transcript from SeekingAlpha.com [ http://tinyurl.com/qc2qqa4 ], with numerous corrections made. )))
Link to webcast replay:
http://ir.peregrineinc.com/events.cfm => http://www.media-server.com/m/p/p5ihgqcu
FULL TRANSCRIPT…
9-9-2014 Q1 FY’15 Earnings Conf. Call (q/e 7-31-14)
WELCOME & FWD-LOOKING STATEMENTS: Chris Keenan (IR) http://www.peregrineinc.com
Speakers: Steve King, Jeff Hutchins, Joe Shan, Paul Lytle; Q&A session.
CEO STEVE KING – OPENING COMMENTS:
Thank you for participating in this afternoon’s call. We are continuing to execute and deliver based on the plans we laid out on our last quarterly call. We continued the expected global expansion of the bavituximab SUNRISE Phase III trial that now has over 130 worldwide clinical sites, nearing the total number of sites we expected to have involved in the study in order to keep us on track to meet our enrollment goals.
In addition, we saw the completion of enrollment in an important Liver Cancer study combining bavituximab with sorafenib. And, we expect to have data from this study as well as data from a Front-Line NSCLC study over the coming months. Joe will update you on clinical developments during his prepared remarks.
In addition to the clinical trials, many of which have also have translational data points built in to tie together pre-clinical data with the clinic, we have also continued to build momentum in our pre-clinical collaborations which now number in the dozens. We are evaluating new combinations & dosing strategies combining bavituximab with chemotherapy, radiation, and immune-oncology approaches, including those targeting CTLA-4, PD-1 as well as other downstream immune checkpoints. In addition, we are evaluating combinations with other immune based approaches including vaccines and adjuvants. It is important to have a robust collaboration program so that we can identify those combinations & approaches that truly stand out and thus support advancing to the clinic. Data from these studies will also play a critical role in our ongoing discussions with potential corporate partners. We have already started to see the fruits of these collaborations with very encouraging results in preclinical models of Melanoma, Colon Cancer, and most recently Breast Cancer when combining bavituximab with other immune checkpoint inhibitors.
Perhaps the most exciting thing about this data when taken as a whole is that the data are remarkably consistent with respect to increases in mature T-cells, and in particular CD8, both positive signals of immune activation. In the studies like these that answer key questions and allow us to formulate the most ideal clinical pathway forward. We expect to be able to share this data and more over the coming months at key scientific and medical conferences. Jeff will update you on the collaboration front during his prepared remarks.
This is an exciting time in the battle against cancer with new approval for immune-oncology agents such as Ono Pharm. & Merck’s anti-PD-1 antibodies which recently received regulatory approvals [nivolumab/BMS&Ono & Keytruda=pembrolizumab/Merck]. This opens the door for new clinical development avenues for novel bavituximab combinations that are already supported by preclinical data we have generated in a number of solid tumor animal models. We are in a unique position with a late stage clinical program for an antibody with a unique immunotherapy mechanism of action that appears to be an ideal fit for combination with approved immunotherapy treatments such as the anti-PD-1 antibodies - truly an exciting time for cancer treatment options and for the bavituximab program.
In addition of these development efforts, we also continue to see a solid performance from our wholly-owned manufacturing subsidiary Avid Bioservices that, coming off a record year, has already begun 2015 strongly with $5.5mm in 3rd-party contract revenue for the quarter and the expansion of our client base. Paul Lytle will update you on the Avid developments as well as the rest of the financial highlights during his discussion.
In summary, we have continued to make significant progress across all aspects of the company, that has us positioned for data presentations, continued revenue performance, and getting closer to the data from the pivotal SUNRISE trial as well as the ongoing expansion immune-oncology development program. With that I will now turn the call over to Jeff, to discuss pre-clinical development efforts.
JEFF HUTCHINS (VP/Preclinical Research):
The purpose of our broad, highly collaborative pre-clinical approach is to guide the direction of future clinical trials in this rapidly evolving IO space. Our goal is to identify the most robust immune-oncology combinations that unlock the full capacity of anti-tumor response without systemic immune-related side effects. The breadth of this approach speaks to the wisdom of working directly with highly recognized individual experts in this space. We are now seeing & presenting the fruits of these efforts and yielding encouraging statistically significant results to date. And most importantly, building a pre-clinical rational to help guide our future clinical trial designs. To that end, we’ve shown this progress of our immune-oncology program, with data recently presented at ImVacS, the “Annual Immunotherapies & Vaccine Summit”, highlighting the combination of a PS-Targeting antibody equivalent to bavituximab and an anti-PD-1 antibody in an immune competent animal model of breast cancer. Results show statically significant tumor suppression, while also demonstrating a significant increase in tumor fighting CD8 T-cells that are into the tumor like environment, compared to an anti PD-1 antibody alone.
[ BAVI MOA 8-11-14: PPHM/VP Dr. Jeff Hutchins’ presentation at ImVacS "Immunotherapies & Vaccine Summit", Boston - PR: http://tinyurl.com/lpjy3u7 ; PDF(31 Slides): http://tinyurl.com/oueldme ]
Additional data from this study, as well as a follow-up data from our Melanoma study, will be presented at the 29th Annual Meeting for the Society of Immunotherapy & Cancer SITC to be held in November [Nov6-9 2014 http://www.eventscribe.com/2014/sitc ]. As Steve mentioned these data align with what we have seen in models of colon & melanoma, and as such warrant expanded investigation with further immune checkpoint inhibitors, agonists, adjuvants, and therapeutic vaccines. With that I’ll turn the call over to Joe to update you on our clinical programs.
JOE SHAN (VP/Clin.&Reg. Affairs) – CLINICAL TRIALS:
Let me start by giving a quick update on our Phase III lung cancer trial, SUNRISE. With nearly 140 clinical sites now opened for enrollment, planned site activation is nearing completion and we remain on track to complete enrollment of approx. 600 patients by the end of calendar year 2015, with 2 planned interim analyses that are event-driven. As I mentioned during our call just a couple of months ago, in conjunction with site activation & enrollment activities, we are implementing an ongoing site engagement and educational initiative for investigators and thought leaders in conjunction with scientific & medical conferences, including the upcoming European Society for Medical Oncology, ESMO 2014 Congress, later this month. [Sept 26-30/Madrid http://www.esmo.org/Conferences/ESMO-2014-Congress ]
Now turning some of our other pipeline indications, starting with Liver Cancer. Today we announce the completion of enrollment of 38 patients in the Phase II part of a Phase I/II IST evaluating bavituximab in combination with sorafenib in patients with Advanced Hepatocellular [Liver] carcinoma. We are continued to be encouraged by the updates from the principal investor, Dr. Adam Yopp of the Univ. of Texas SW Medical Center in Dallas, and we look forward to his presentation of the full clinical results at a future conference. Meanwhile, as part this trial, we have been able to generate translational data showing immune changes in patient tumor samples which are consistent with the immuno-modulating mechanism observed in preclinical models. These data will be presented at the 29th Annual Meeting of the Society for the Immunotherapy of Cancer conference [SITC] at the beginning of November. [Nov6-9 2014 http://www.eventscribe.com/2014/sitc ]
Today we also announced that data from the Phase Ib IST evaluating bavituximab in combination with carboplatin+pemetrexed in 25 patients with previously untreated Stage IV NSCLC has been accepted for presentation as at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology (MSTO) at the end of October. [Oct30-Nov1, Sponsors: ASTRO, ASCO, IASLC, Univ. of Chicago http://www.thoracicsymposium.org ]
And lastly, as you’ve just heard from Jeff, we continued to generate preclinical data to inform clinical development about bavituximab in Breast Cancer. We are also looking forward to the manuscript publication of the final result of the Phase I trial which combines bavituximab & paclitaxel in the near future. Recall preliminary results demonstrated an encouraging 85% tumor response rate in patients with HER2-metastatic breast cancer. So as you can see, several ISTs are expected to readout over the next few months, and these clinical results together with our expanding preclinical I-O pipeline support not only extending the potential combination uses of bavituximab in the clinic, but also advancing clinical development in Breast Cancer and Liver Cancer as resources permit. And with that I’ll turn the call over to Paul.
CFO Paul Lytle:
Now turning to our financials, it’s important to note that we continue to closely manage our operations in line with our cap position while balancing our various sources of capital. One important source of capital is derived from our contract mfg. business where we generated $5.5mm in revenue this qtr and we anticipate that contract mfg. revenue will be $19-23mm for the full FY [May’14-Apr’15] as mentioned on the previous call. In addition, we supplemented our cap position this qtr with $9.5mm in net proceeds received from the sale of Series E Preferred Stock sold at $25/sh. This funding vehicle represents less-dilutive capital to the company since its convertible into common shares at a conv. price of $3/sh. With these addl. sources of capital and taking into consideration our statement of operations, we ended the qtr with over $73mm in cash, and based on our current projections this represents sufficient capital to execute on our business plans for at least the next 12-mos. Now turning to our statement of operations, we saw an expected increase in our net loss this qtr as we continue to execute on our #1 R&D goal, advancing the Phase III SUNRISE trial. As we invested in the Phase III trial, R&D spending increased to approx. $10mm this qtr, thereby increasing our net loss to approx. $13mm. As a result, we saw a similar increase in our cash burn from operations to $11mm this qtr, representing our net loss minus non-cash expenses. Our financial goals are centered on maintaining a solid cash position and investing these proceeds into our novel, immune-oncology program led by bavituximab and the Phase III SUNRISE trial. We will continue to closely manage our operations in line with our cash position while balancing the various sources of capital.
Q&A: [14:36 mark]
1. Joe Pantginis – Roth Capital Partners: [ http://www.roth.com & https://roth2.bluematrix.com/docs/pdf/BLUE.pdf ]
JP: ”With regard to the site openings, that’s great progress, about 130 sites you said, and enrollment trends that you’ve been seeing - how well have they been tracking with your projections before the study started?”
SK: We haven’t given a lot of addl. details other than the fact that the trial is getting up to close to full steam as far as number of sites involved in the study, and that’s most critical of course because once you get all the sites up running and that’s when you reach the maximum enrollment rates. So at this point, we’re simply saying that we are on track for the initial estimate of less than a 2-year enrollment and if we start to deviate significantly one way or another from that, we’ll let everyone know, but at this point we feel comfortable that we are on track.
JP: ”Okay that’s fair and then with regard to Joe mentioning maybe at SITC we would be seeing some translational data from the Liver Cancer study, so I was just wondering if there is any potential teaser there and then the next layer for that question is with regard to your ongoing business dev. activities, have you seen any change in the tenor of those discussions with the recent approval of Keytruda [Merck’s Anti-PD-1 drug pembrolizumab, aka MK-3475, for Adv. Melanoma]”
SK: Sure, I can get things started and then turn it over to Jeff & Joe for a little bit more color as far as the translational work goes, but, yes, there has been an awful lot of interest spurred by the recent regulatory success of the Anti-PD-1 antibodies and moving those into the marketplace, that clearly opens up some very nice opportunities down the road for new clinical trials that can be run, but also in ways to best use bavituximab, because we really feel like we are in a unique position with a late-stage immune-oncology agent that really looks like it should be a perfect fit with these agents that are now coming on to the market from a combination standpoint. I think that’s definitely heated up the discussions, as well as all the translational data and other study-related data from the preclinical models that we've been running. As far as kind of a teaser, I think we've said right from the beginning that one of the things we've been looking for out of the number of the IST’s are really the correlative data that goes along with the animal studies we've completed showing basically the symptomatic changes in the profile of the immune cells that are present in the tumor microenvironment and more broadly in the animals themselves, so that’s kind of data in general that of course we’re looking to present. I’ll let Jeff or Joe add a little bit to that.
Jeff Hutchins: As Joe said, really the teaser is that we are seeing some consistency between what we first identified in the animal models as this increase in CD8 positive T-cells translating quite nicely with the liver samples.
Joe Shan: Yes, I think the totality of the immune changes, of course the CD8 changes are interesting, but we basically are recapitulating all of the pre-clinical steps within the immune system changes within the tumor. So it’s more than just CD4, CD8, T-regs for example. There is a lot of information on it we’ll be sharing.
SK: To expand on that, obviously the ability to then correlate this with patient outcomes, and this is all very important data from a partnering standpoint also, and this is exactly the kind of data that is driving a lot of interest we are seeing now from both partnering standpoint as well as from collaborative standpoint. In particular, with data like Liver Cancer, as was stated before, our goal is actually with partnering. Liver Cancer is a huge indication throughout the Asia-Pacific region, so that’s clearly a very attractive next potential target outside of NSCLC for some of those territories.
2. Roy Buchanan for Charles Duncan – Piper Jaffray [http://www.piperjaffray.com – 3-5-13 Initiates PPHM: http://tinyurl.com/bxhntk3 ]
RB: “I wonder if you can go into a bit more detail about the combo programs with vaccines & adjuvants, specifics around which vaccines & adjuvants, and maybe what we might see over the next 12-mos.”
Jeff Hutchins: We can go back quite a ways to published data where actually radiotherapy works quite well as an adjuvant and a vaccine if you will. So, what we are trying to do is go back and really revisit some of those early observations now that we understand how well bavituximab does to re-polarize those myeloid cells that are so important in vaccine presentation and so forth. So, you really could go through and re-evaluate some of the recent failures in clinical vaccines and ask the question now, if you re-polarize and change the local micro environment around the tumor, will these vaccine now be much more effective? That really summaries our excitement around this area.
RB: ”Is there any specific I guess platform or technology that you are looking at service dendritic cell or…”
Jeff Hutchins: Well, as Steve mentioned, we have a number of collaborations that really cover all these areas and it’s really a focus in a sense to make sure we are hitting the right combination to put really, if you will, put the immune system back together to respond appropriately to the tumor.
SK: Yes, and our goal is to look at all the different areas so which haven’t been now public with what the collaborations are, but goal is to touch on the dendritic cell vaccines as well as antigen-based vaccines, where we see some promising results and things we can build on from this growing body of evidence of the immune system changes we are seeing with the changes in the tumor-associated macrophages as well as some of the other immune components.
RB: ”That makes sense… do you have any expectations on when we might see the first interim for SUNRISE?”
Joe Shan: It is really impossible to predict. Obviously it’s event-driven, so at this point we’re not trying to project that. We will focus on enrolling the patients and then… you know.
SK: It’s obviously event-driven, so there are other variables besides just the enrollment patterns themselves, and just how the patients are doing, and what have you.
3. George Zavoico (MLV & Co.): http://www.mlvco.com
GZ: ”Regarding the breast cancer data, the last time this data was presented, there were 4 patients still on therapy. And, you said in your press release that the results might be revealed in the publication. Do you anticipate that happening before an update at a medical conference which is sort of the usual sequence of events?”
Joe Shan: Not necessarily, the investigator has prepared a manuscript, which we expect to be submitted for publication shortly. It’s going to contain obviously the results previously, but in a more fuller description, and then we’ll have some updates on the clinical endpoints like progression-free survival for example.
GZ: ”So there will be new date obviously then.”
Joe Shan: Yes.
GZ: ”With regard to patents, bavituximab is an immune checkpoint inhibitor, sort of a new look to the antibody – that wasn’t how it was originally conceived. Does that present an opportunity for you to file the new patents for method of use in combination with immune checkpoint inhibitors or how does that effect or improve your patent portfolio on bavituximab or PS-Targeting antibodies if at all?”
SK: Obviously as we've gone through the development stages we've filed additional patents that build on the original patents, particularly with different combinations, as you were saying, and new ways to look at how the drug is used, and so we think that those certainly help broadened the estate, certainly some of the combinations are covered well beyond the original patents that cover things like the antibody and the targeted cell. Yes, we are always continuing to evaluate new inventions, the impacts of those on the overall portfolio, the length of time for coverage, and we feel pretty comfortable that at this point we have everything pretty much covered from what we currently have in the clinic. Again, that’s an ongoing process and it never stops and we have number of committees that do nothing but simply look at those sort of aspects of the development of the drug.
GZ: ”So, we can anticipate perhaps some extensions in the patent life here then, for certain combinations, it sounds like. With regard to the budget, Paul, you outlined how long you expect the cash to last. What exactly is included in the budget, because what you’re implying with all the results that are coming out in breast & liver, it seems that it would behoove you to try and get into addl. trials in other indications as quickly as possible. With liver results coming out, the breast results coming out, it’s quite possible that the next trial could start next year if you find the right partners or if you just decided to go on your own. If there any of those new indications included in your budget?”
Paul Lytle: That’s a very good question. Our goal right now is really executing on the Phase III trial, the SUNRISE trail - obviously that’s currently in our budget. When we talk about having sufficient cash resources to fund our operation for at least the next 12-mos., that’s a conservative estimate that so we really mean at least the next 12-mos. when we project out 12-mos. or so in terms of providing that type of forecast. So, this is a conservative-type estimate when we put out our projections. In terms of new indications, you hit the target. We do want to start some new collaborations - that could come through other funding opportunities; that could come through partnering opportunities, and other avenues. So, we are definitely going to pursue that. We are as excited as you to initiate some of these new studies, and we just want to make sure first and foremost we can execute on the Phase III trial first and then as new opportunities come to fruition we can expand our R&D pipeline to include some of those other things.
SK: Just to extend on that, the one of the points Paul made on partnering is very important because really at this point bringing on board a partner may help us to complete executing the clinical trial, like bringing in capital, but from an operations standpoint, the trial is already underway and basically is on track. So, when we think about partnering we’re really looking at expanding into some of these new indications, and clearly Breast Cancer & Liver Cancer are right now are at the top of the list, based on the totality of the preclinical & clinical data we've generated to-date. We view that as a great way to move the program forward to expand it, and really then also be able to cover commercialization in various territories.
GZ: ”My final question is kind of philosophical in the sense that the immune checkpoint space has been very exciting lately and you have made an effort to educate everyone about the potential of bavituximab in that space, and yet if you look at your market capitalization since about April, it really hasn’t moved very much and apart from the spike in March, it really hasn’t moved much since January. So, what do you attribute, if you wish to comment on it, that sort of plateau performance, and what do you think you can do to help change that perception?”
SK: We are approaching this on a number of different fronts. First is getting out and really kind of telling the story to as many funds and institutions within the investment space. I think also the kind of collaborations that we've entered into and the presentation of clinical data at these key medical & scientific conferences is also critical, because up to the last few years we typically may not have been present that most of the major immunotherapy-type conferences, whereas now, clearly, we are constant figures at these conferences and presenting data. I think maybe even most importantly is that our data is very consistent with what people are showing with other test systems. So, it really is resonating with people in a way it hasn’t in the past. But, it’s a ground effort – it’s publications, presentations. And then, of course, clinical data will eventually trump all that, and that’s the reason that executing on the Phase III SUNRISE trial is so important as a backbone to getting the recognition for this program. It’s just going to be continuing to execute, be on the road. I think, the more the word gets out there, we think the more we’ll be clearly in the middle of the space. As I said in the prepared remarks, to me we’re in a really unique position because, while there’s a lot of interest in immunotherapy, there’s not many that are in the middle of their pivotal Phase III study like we are. We view that is a real benefit and I think something it will drive a lot of interest because once a drug’s on the market now, of course, it opens up all kind of avenues for combinations and others ways to use the drug. We’re really looking forward to continuing to execute on that and take advantage of sort of that position being more advanced than a lot of the other immune checkpoints at this point.
MR. KING’S CLOSING COMMENTS:
I’d like to thank you all again for participating in today’s call. We have begun the FY well-positioned with clinical data expected in the near-term from multiple trials, as well as pre-clinical data from our immune-oncology program. As we said earlier, we believe that we are in a unique position and feel this is an important time for the company and its programs as we work to understand the full potential of this novel immunotherapy. So again, thank you and we look forward to updating you with this progress throughout the quarter.
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9-9-14 PR: Peregrine Pharmaceuticals Reports First Quarter FY2015 Financial Results and Recent Developments
SUNRISE Phase III Lung Cancer Trial Operational at Over 130 Sites Worldwide
Preclinical Data in Breast Cancer Supports Immuno-Oncology Combinations With Bavituximab
Clinical Data From Liver, Breast and Front-Line Non-Small Lung Cancer Trials Anticipated in the Coming Months
Enrollment Complete in Bavituximab Plus Sorafenib Investigator-Sponsored Trial in Patients With Advanced Liver Cancer
Company Delivers Solid First Quarter With $5.5 Million in Contract Manufacturing Revenue
TUSTIN, CA, 9/9/14: Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM) (NASDAQ: PPHMP), a biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment and diagnosis of cancer, today announced financial results for the first quarter of fiscal year (FY) 2015 ended July 31, 2014 and provided an update on its advancing clinical pipeline led by its investigational immuno-oncology candidate bavituximab and reviewed other corporate developments.
"We continued to advance the bavituximab clinical program on multiple fronts with the major focus on executing the SUNRISE Phase III trial which is progressing well with the initiation of new global clinical sites bringing the total participating sites to over 130. In addition, our collaborator at UT Southwestern recently completed enrollment in an important liver cancer study opening the door for data from this study as well as other bavituximab clinical trials to be presented over the coming months," said Steven W. King, president and chief executive officer of Peregrine. "In addition to the clinical trial activities, we have a robust preclinical collaboration program evaluating new combinations and dosing strategies combining bavituximab with chemotherapy, radiation and immune-oncology approaches that are constantly yielding important data that will help guide and expand the clinical program."
BAVITUXIMAB ONCOLOGY PROGRAM HIGHLIGHTS
Lead Indication in Second-Line Non-Small Cell Lung Cancer:
The company continues to actively open 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, 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 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 130 sites worldwide have been initiated in this pivotal trial.
For additional information about the SUNRISE trial please visit www.sunrisetrial.com or ClinicalTrials.gov using the Identifier 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. Final 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 are anticipated to be published in a manuscript in the near future.
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) has completed enrollment of the Phase II portion and data from this trial are expected to be presented at an upcoming conference. "The Phase II portion of this trial has completed enrollment with a number of patients currently on treatment, the longest of whom has been on treatment for 18 months," said Adam Yopp, M.D., Assistant Professor of Surgery at the University of Texas Southwestern Medical Center's Simmons Cancer Center. "While the results from this trial are preliminary, I believe they are promising. I am excited about this potential combination given the new understandings about bavituximab's mechanism and I look forward to sharing the full set of data from this Phase II trial at a future scientific conference."
• A Phase Ib IST evaluating bavituximab in combination with carboplatin and pemetrexed in up to 25 patients with previously untreated Stage IV NSCLC has completed enrollment with interim data accepted for presentation at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology to be held October 30 - November 1, 2014.
• A Phase I IST evaluating bavituximab in combination with capecitabine and radiation therapy in up to 18 patients with Stage II or III rectal adenocarcinoma is open for patient enrollment.
• A Phase Ib IST evaluating bavituximab in combination with Bristol-Myers Squibb's ipilimumab (Yervoy®) in up to 24 patients with advanced melanoma is open for patient enrollment.
BAVITUXIMAB IMMUNO-ONCOLOGY DEVELOPMENT PROGRAM
This program continues to explore the potential of combining bavituximab with other immunotherapies, experimental immuno-oncology drugs including checkpoint inhibitors, as well as vaccines. Recently, data presented at ImVacS, The Annual Immunotherapies and Vaccine Summit shows that the combination of a PS-targeting antibody equivalent to bavituximab administered with an anti-PD-1 antibody displays statistically significant tumor growth suppression while also demonstrating a significant increase in tumor-fighting T-cells into the tumor microenvironment compared to anti-PD-1 antibody treatment alone in an immune competent animal model of breast cancer.
Data from the company's immuno-oncology program, as well as clinical translational data aimed at assessing and measuring changes in immune response pre- and post-treatment from the liver cancer IST will be the subject of presentations at the 29th Annual Meeting of the Society for the Immunotherapy of Cancer (SITC) to be held November 6-9, 2014. [SITC 2014: http://www.eventscribe.com/2014/sitc ]
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 started the fiscal year on a strong note generating $5.5 million in contract manufacturing revenue for the first quarter," said Paul Lytle, chief financial officer of Peregrine. "In addition, Avid has been successful in expanding its client roster while also continuing to evaluate manufacturing options that would create new manufacturing capacity for the potential commercial launch of bavituximab in addition to providing Avid with increased capacity for its clients."
FINANCIAL RESULTS
Total revenues for the first quarter of FY 2015 were $5,496,000, compared to $4,688,000 for the same quarter of the prior fiscal year. The increase was primarily attributed to an increase in contract manufacturing revenue generated from Avid Bioservices.
Contract manufacturing revenue from Avid's clinical and commercial biomanufacturing services provided to its third-party clients for the first quarter FY 2015 were $5,496,000, compared to $4,581,000 for the same quarter of the prior fiscal year. Peregrine expects contract manufacturing revenue 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 first quarter of FY 2015 were $18,667,000, compared to $12,308,000 in the first quarter of FY 2014. This increase was primarily attributable to current quarter increases in research and development expenses associated with the SUNRISE Phase III trial and incremental increases in selling, general and administrative expenses. For the first quarter FY 2015, research and development expenses were $10,201,000, compared to $5,304,000 for the first quarter of FY 2014. For the first quarter FY 2015, selling, general and administrative expenses were $4,883,000, compared to $4,334,000 for the first quarter of FY 2014.
Peregrine's consolidated net loss attributable to common stockholders was $14,157,000, or $0.08 per share, for the first quarter of FY 2015, compared to a net loss attributable to common stockholders of $7,600,000, or $0.05 per share, for the same quarter of the prior year.
Peregrine reported $73,256,000 in cash and cash equivalents as of July 31, 2014 compared to $77,490,000 at fiscal year ended April 30, 2014.
More detailed financial information and analysis may be found in Peregrine's Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.
CONFERENCE CALL
Peregrine will host a conference call and webcast this afternoon, September 9, 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 September 16, 2014 by calling (855) 859-2056, or (404) 537-3406 and using passcode 94131393.
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.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
THREE MONTHS ENDED
July 31, 2014 July 31, 2013
Unaudited Unaudited
REVENUES:
Contract manufacturing revenue $ 5,496,000 $ 4,581,000
License revenue - 107,000
Total revenues 5,496,000 4,688,000
COSTS AND EXPENSES:
Cost of contract manufacturing 3,583,000 2,670,000
Research and development 10,201,000 5,304,000
Selling, general and administrative 4,883,000 4,334,000
Total costs and expenses 18,667,000 12,308,000
LOSS FROM OPERATIONS (13,171,000 ) (7,620,000 )
OTHER INCOME (EXPENSE):
Interest and other income 42,000 21,000
Interest and other expense - (1,000 )
NET LOSS $ (13,129,000 ) $ (7,600,000 )
COMPREHENSIVE LOSS $ (13,129,000 ) $ (7,600,000 )
Series E preferred stock accumulated dividends (1,028,000 ) -
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS $ (14,157,000 ) $ (7,600,000 )
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING
Basic and diluted 179,118,255 149,393,630
BASIC AND DILUTED LOSS PER COMMON SHARE $ (0.08 ) $ (0.05 )
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
JULY 31,
2014 APRIL 30,
2014
Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 73,256,000 $ 77,490,000
Trade and other receivables, net 1,391,000 1,332,000
Inventories 5,998,000 5,530,000
Prepaid expenses and other current assets, net 883,000 1,419,000
Total current assets 81,528,000 85,771,000
Property and equipment, net 3,647,000 2,447,000
Other assets 2,432,000 2,327,000
TOTAL ASSETS $ 87,607,000 $ 90,545,000
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 5,080,000 $ 2,434,000
Accrued clinical trial and related fees 1,887,000 4,433,000
Accrued payroll and related costs 2,654,000 3,837,000
Deferred revenue, current portion 4,670,000 5,241,000
Customer deposits 6,226,000 5,760,000
Other current liabilities 606,000 502,000
Total current liabilities 21,123,000 22,207,000
Deferred revenue, less current portion - 292,000
Other long-term liabilities 892,000 347,000
Commitments and contingencies
STOCKHOLDERS' EQUITY:
Preferred stock-$0.001 par value; authorized 5,000,000 shares; issued and outstanding 1,175,000 and 775,000, respectively
1,000
1,000
Common stock-$0.001 par value; authorized 325,000,000 shares; issued and outstanding - 179,216,032 and 178,871,164, respectively
179,000
179,000
Additional paid-in capital 481,807,000 470,785,000
Accumulated deficit (416,395,000 ) (403,266,000 )
Total stockholders' equity 65,592,000 67,699,000
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 87,607,000 $ 90,545,000
Contact: Christopher Keenan, Peregrine Pharmaceuticals, Inc., (800) 987-8256, info@peregrineinc.com
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[ From 10-Q header: “As of Sept. 5, 2014, there were 179,505,424 shares of issuer’s common stock
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Latest 10K 4-30-14 iss. 7-14-14: http://tinyurl.com/mhva3k3 PR: http://tinyurl.com/o2e4a4g (Cash 4-30-14=$77.5mm)
Latest 10Q 7-31-14 iss. 9-9-14 http://tinyurl.com/phw6dkp PR: http://tinyurl.com/ktrfswj (Cash 7-31-14=$73.3mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
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Updated PPHM REVS-BY-QTR TABLE, now thru FY15/Q1 (qe 7-31-14), per the 7-31-14 10-Q (http://tinyurl.com/phw6dkp ) issued 9-9-14. Deferred-Revs at 7-31-14, going fwd into FY’15/Q2 (q/e 10-31-14), total $4.7mm, down from the $5.2mm of Deferred-Revs at 4-30-14 that drove into FY’15/Q1.
Total Revs since May’06: ($108.0mm/Avid + $24.1mm/Govt + $2.1mm/Lic.) = $134.2mm
Avid’s Gross-Profit over last 4 qtrs: $9.2mm on revs of $23.2mm (GM% = 40%)
==> Recall, Avid Rev$ from Gov’t DTRA Contract work (6/30/08 – 4/15/11, totaling $24.15mm), went into GOVT-REVS, not AVID-REVS, in the Financials.
Avid’s website: http://www.avidbio.com
*The 10-Q’s define OPER.BURN as, ”Net cash used in operating activities before chgs. in operating assets & liabilities”.
The 7-21-2001 10Q explains OP.BURN very nicely:
“RESULTS OF OPERATIONS. Before we discuss the Company's total expenses (cash & non-cash expenses), we would like to discuss the Company's operational burn rate (cash expenses used in operations, net of interest and other income) for q/e July 31, 2001 compared to the same period in the prior year. The operational burn rate is calculated by taking the net income (loss) from operations and subtracting all non-cash items, such as the recognition of deferred license revenue, depreciation and amortization and stock-based compensation expense.”
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- - - - - - - - PPHM’s Fiscal Qtr’s (FY runs May – April):
FY’10-Q3 = q/e 1-31-10 – rep. 3-11-10 Thu (B4 mkt)
FY’10-Q4 = q/e 4-30-10 – rep. 7-14-10 Wed (after mkt)
FY’11-Q1 = q/e 7-31-10 – rep. 9-9-10 Thu (after mkt)
FY’11-Q2 = q/e 10-31-10 – rep. 12-9-10 Thu (after mkt)
FY’11-Q3 = q/e 1-31-10 – rep. 3-11-11 Fri (after mkt)
FY’11-Q4 = q/e 4-30-11 – rep. 7-14-11 Thu (after mkt)
FY’12-Q1 = q/e 7-31-11 – rep. 9-9-11 Fri (B4 mkt)
FY’12-Q2 = q/e 10-31-11 – rep. 12-12-11 Mon (after mkt)
FY’12-Q3 = q/e 1-31-12 – rep. 3-9-12 Fri (after mkt)
FY’12-Q4 = q/e 4-30-12 – rep. 7-16-12 Mon (after mkt)
FY’13-Q1 = q/e 7-31-12 – rep. 9-10-12 Mon (B4 mkt)
FY’13-Q2 = q/e 10-31-12 – rep. 12-10-12 Mon (after mkt)
FY’13-Q3 = q/e 1-31-13 – rep. 3-12-13 Tue (after mkt)
FY’13-Q4 = q/e 4-30-13 – rep. 7-11-13 Thu (after mkt)
FY’14-Q1 = q/e 7-31-13 – rep. 9-9-13 Mon (after mkt)
FY’14-Q2 = q/e 10-31-13 – rep. 12-10-13 Tue (after mkt)
FY’14-Q3 = q/e 1-31-14 – rep. 3-7-14 Fri (B4 mkt)
FY’14-Q4 = q/e 4-30-14 – rep. 7-14-14 Mon (after mkt)
FY’15-Q1 = q/e 7-31-14 – rep. 9-9-14 Tue (after mkt)
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“Going Concern” statement ELIMINATED from 4-30-13 10-K issued 7-11-2013…
2012: 4-30-12 10-K iss. 7-16-12 http://tinyurl.com/79o57b2
Pg.68: “As more fully described in Note 2, the Company’s recurring losses from operations and recurring negative cash flows from operating activities raise substantial doubt about its ability to continue as a going concern.”
2013 & 2014 10-K's: http://tinyurl.com/p58jcbw & http://tinyurl.com/mhva3k3 ==> ((((NO GOING CONCERN STATEMENT INCLUDED.))))
CASH a/o 4-30-13: $35.2mm
CASH a/o 6-30-13: $42.6mm
CASH a/o 7-31-13: $41.6mm
CASH a/o 10-31-13: $44.4mm
CASH a/o 1-31-14: $63.2mm
CASH a/o 2-15-14: $79.7mm
CASH a/o 4-30-14: $77.5mm
CASH a/o 6-30-14: $78.3mm
CASH a/o 7-31-14: $73.3mm
= = = = = = = = = = 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 9-9-2014:
http://www.peregrineinc.com/images/stories/pdfs/sept-2014_corp_fact_sheet.pdf
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3-10-14: CEO Steve King’s 22min. talk at ROTH Conf. (DanaPT CA) - SLIDES http://tinyurl.com/n65myfk
3-7-14 Qtly. Conf. Call (King/Shan/Garnick/Lytle) Transcript http://tinyurl.com/kh9cnrg
...CEO S.King: “I don't want to overuse the word ‘excitement’, but these are truly exciting times that have positioned us for success on all fronts.”
12-10-13 Qtly. Conf. Call (King/Shan/Garnick/Hutchins/Worsley/Lytle) Transcript http://tinyurl.com/mw776mk
...CEO S.King: “We believe that Peregrine is uniquely positioned among the companies developing immunotherapies… and that because of our current valuation, we represent a unique investment opportunity.
• All of Dr. Robert Garnick's public comments (thru 3-7-2014) while at Peregrine: http://tinyurl.com/obvwyuh Steve King said 6-29-11, "Rob is the ringmaster."
• 6-29-11 Minyanville article, "Peregrine Pharma's Secret Weapon [Robert Garnick]" http://tinyurl.com/9jtnan o
• Examples of Dr. Garnick's work at Genentech on Avastin (bevacizumab) approvals: http://tinyurl.com/yg7vtqa
PS-TARGETING SCIENCE: "Evolution has favored pathogenesis that resembles apoptosis."
Dr. Judah Folkman: ”This [Thorpe’s VTA research] is very promising and very elegant work... The whole goal is really 2-part, reducing the harsh side effects of cancer treatment, and reducing the chance that some cancer cells will evade treatment. That would be a big step in the next decade, and anti-vascular therapy will play a major role." (’97 & ’02 http://tinyurl.com/k5qe96g & http://tinyurl.com/n6vh9hp )
Peregrine's Bavituximab & Cotara Technologies: http://www.peregrineinc.com/technology/overview.html
Peregrine's Clinical Trials website: http://PeregrineTrials.com
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Bavituximab MOA & Clinical Data: http://www.peregrineinc.com/pipeline/bavituximab-oncology.html
...Bavi Publications: http://www.peregrineinc.com/publications/publications.html
...Bavi Posters & Presentations: http://www.peregrineinc.com/publications/posters-and-presentations.html
Bavi MOA: Video (3:34) added ~3-2014 http://vimeo.com/87116642 "Bavituximab: A Novel Immunotherapy Candidate Targeting an Upstream Immune Checkpoint to Fight Cancer"
Bavi MOA: Video (1:33) on Bavi’s Immunotherapeutic MOA added to Youtube on 3-27-14 https://www.youtube.com/watch?v=Esewl35JD8s
BAVI MOA 8-11-14: PPHM/VP Dr. Jeff Hutchins’ presentation at ImVacS "Immunotherapies & Vaccine Summit", Boston - PR: http://tinyurl.com/lpjy3u7 ; PDF(31 Slides): http://tinyurl.com/oueldme
...MLV’s Dr. George Zavoico’s 8-27-14 report on Dr. Jeff Hutchins’ 8-11-14 ImVacS/Boston Bavi MOA presentation: http://tinyurl.com/l3tw63c
BAVI MOA 5-28-14: Dr. Rolf Brekken’s 47min CRI “Cancer Immunotherapy” webinar about Bavituximab as an Upstream/Global Immune Checkpoint Inhibitor – REPLAY: http://tinyurl.com/lxgftyx
. . .CRI=Cancer Research Institute (NYC – Supported by BMS): http://www.cancerresearch.org - Facebook: http://tinyurl.com/pbmhb2z , https://twitter.com/CancerResearch
. . .CRI launches “Answer to Cancer” (cancer immunotherapy) website http://www.theanswertocancer.org
. . .8-12-14: CRI adds Youtube links to the 5-28-14 CRI Immunotherapy webinar, incl. Dr. Brekken's talk "about Bavi and how it works against lung, liver, and other kinds of cancers" http://tinyurl.com/ps5h6h8
BAVI MOA 3-25-14: Dr. Rolf Brekken’s 40min talk at NYAS Lung Cancer Symposium http://tinyurl.com/lq9stnk (45 Slides)
. . .Dr.Brekken’s talk: “Antibody-mediated Inhibition of PS - A Novel Strategy for Immune Checkpoint Blockade” (the 5 speakers: Jessica Donington, Roy Herbst, Balazs Halmos, Suresh Ramalingam, Rolf Brekken)
BAVI MOA: 12-2013 Bavi’s Immunotherapeutic MOA overviewed by UTSW’s Brekken/Huang in Pan European Networks Jrnl. http://tinyurl.com/lnb46pq
BAVI MOA 11-9-13: Annual SITC (WashDC) – 2 posters about Bavi’s Immunostimulatory MOA http://tinyurl.com/mjaweu5
...“We are actively working towards initiating a clinical trial in the coming months to further investigate the potential synergistic effects of bavituximab and an approved [anti-CTLA-4] immunotherapy in patients with Melanoma."
10-28-13 IASLC/Sydney: “Immune Checkpoints in the Tumor Environment: Novel Targets & the Clinical Promise of Combined Immunotherapies” http://tinyurl.com/mjaweu5
…Symposium speakers: Scott J. Antonia/MD-PhD(H.Lee Moffitt CC), Dmitry I. Gabrilovich/MD-PhD(Wistar Inst), Rolf A. Brekken/PhD(UTSW), David E. Gerber/MD(UTSW)
BAVI MOA: 8-19-13 Data Supporting Bavituximab’s Immunotherapy MOA Published in “Cancer Immunology Research” (AACR) - http://tinyurl.com/mhjftka (PDF)
…“PS-Targeting Antibody Induces M1 Macrophage Polarization & Promotes Myeloid-Derived Suppressor Cell Differentiation” (Thorpe etal)
BAVI MOA: 8-13-13 PPHM/VP Dr. Jeff Hutchins’ Presentation on the Downstream Immunostimulatory Effects/Moa of PS-targeting antibodies (like Bavi) at CHI’s “Immunotherapies Congress”/Boston http://tinyurl.com/m6h2tvt
BAVI MOA: 10-12-12 NMB article on how Bavi "Induces Innate & Specific Anti-tumor Responses" http://tinyurl.com/cw9odb8
BAVI MOA: 5-1-12 Dr. Phil Thorpe's 46min talk at NYAS PS-Targeting Symposium http://tinyurl.com/9792gl5
. . .Symposium title: "Phosphatidylserine (PS) Asymmetry - Therapeutic Apps. in Cancer & Infectious Disease Symposium"
. . .Replays of 5 speakers: Alan Schroit, Chris Reutlingsperger, David Ucker, Ari Helenius, Philip Thorpe
BAVI MOA: 5-26-11 Dr.Thorpe's keynoter at Recombinant-Mabs/Barcelona http://tinyurl.com/3klpodc & http://tinyurl.com/3m33h33
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Roth/J.Pantginis 9-10-14 PPHM update…
Roth Capital /Joe Pantginis - init. 7-15-10 Buy/PT=$10, CURR: Buy/$5 http://www.roth.com
. . .Universe (click link bottom right): http://roth.bluematrix.com/docs/pdf/BLUE.pdf
9-10-14/PPHM: FY1Q15 RESULTS; BROADENING BAVITUXIMAB'S PROFILE
PPHM announced FY15/Q1 results, reporting EPS of ($.08), compared to our and the consensus estimate of ($.06). Total revenues for 1Q15 were $5.5mm vs. our est. of $5mm and consensus est. of $6mm. With IST data readouts in the upcoming months, we believe mgt. will be able to leverage that into expanding bavi's profile and further drive partnership discussions. The company ended Q1 (7-31-14) with $73.3mm in cash, which mgt. believes is sufficient to fund operations for ~12 mos. PPHM reiterated guidance for contract mfg. revenue for FY2015 of $19-$23mm.
Reiterate Buy and $5 target.
IMPACT
Alongside the SUNRISE Phase III study ongoing in over 130 sites, there will be addl. focus on data readouts from other programs in the upcoming months:
1) The Phase I/II study of bavituximab in combination with sorafenib in Hepatocellular (Liver) Carcinoma will have data presented at the Annual Meeting of the Society for the Immunotherapy of Cancer (SITC http://www.eventscribe.com/2014/sitc ) in early November
2) The Phase Ib of bavituximab in combination with carboplatin+pemetrexed in untreated stage IV NSCLC will have preliminary data presented at the Chicago Multidisciplinary Symposium in Thoracic Oncology (MSTO http://www.thoracicsymposium.org ) in late October.
Additionally, PPHM will present more data from the immuno-oncology program combining bavituximab with other immunotherapies, specifically, an anti-PD-1 checkpoint inhibitor, at SITC.
Data from the Liver Cancer study as well as from the immunooncology program should increase visibility, driving up potential partnering interest for bavituximab.
Recall that PPHM also indicated that it is looking to expand bavituximab's profile into other indications, particularly in Breast Cancer. At ASCO 2014 PPHM presented data from an IST of bavituximab+paclitaxel in HER2-neg. metastatic breast cancer, showing that 85% of patients achieved ORR, with 15% achieving CR by RECIST.
ACTION
We reiterate our Buy rating and $5 target. With Peregrine being a pivotal stage company, we view the risk/reward profile as favorable, and we believe visibility from the broadening bavituximab profile and partnering potential should drive the stock in 2014.
= = = = = = =KNOWN UPCOMING EVENTS: http://ir.peregrineinc.com/events.cfm
Sep26-30: “ESMO 2014 (Eur. Society for Medical Oncology)”, Madrid http://www.esmo.org/Conferences/ESMO-2014-Congress (Industry Partner: Peregrine Pharm.)
Oct6: CRI’s 22nd Annual Intl. Cancer Immunotherapy Symposium - "Cancer Immunotherapy: Out of the Gate”, NYC http://tinyurl.com/kvcbggw
Oct16 10:30amPT: Annual Shareholders Meeting (Irvine Marriott) http://ir.peregrineinc.com/events.cfm Proxy 8-28-14 (Def14A): http://tinyurl.com/kvnxgwg
Oct20-23/Avid(booth#1045): BioProcess Intl. (BPI) Conf. & Exhibition, Boston http://convention.bio.org/2014
Oct 30-Nov1: Multidisciplinary Symposium on Thoracic Oncology (MSTO), Chicago http://tinyurl.com/p2l43mt Sponsors: ASTRO, ASCO, IASLC, Univ/Chicago
...Per Joe Shan 9-9-14: “Data from the Ph.Ib IST Univ-Pitt. Bavituximab+CP/1stLine/Stage4/NSCLC”
…Nov1 10-10:30: Speaker Scott J. Antonia (PPHM SAB/KOL/Moffitt), “Immune …Modulation of Lung Cancer”
Nov6-9: “SITC 2014 – 29th Annual Meeting”, Natl-Harbor MD http://tinyurl.com/k4vprzd (per 9-9-14 C.Call/Jeff Hutchins & Qtly-Financials PR)
...Bavi+Yeryoy/Melanoma IST data (Ph1 IST/UTSW/Dr. Arthur Frankel)
...Bavi+Sorafenib/Liver Cancer IST data (5 sites: 3/UTSW, Parkland-Hosp, Dallas/VA, PI: Dr. Adam Yopp)
Nov22: ESMO Symposium on Immuno-Oncology 2014, Geneva http://tinyurl.com/ofljfgs
…11:30-11:50am, David Carbone, MD/PhD (Ohio-ST, PPHM KOL/SRB), session=”Advances in Cancer Immunotherapy; from Vaccines to Antibodies & Cell Therapies”, talk=”Immune Checkpoint Inhibitors in Lung Cancer”
Dec7-11/Avid(booth#319): IBC's Antibody Eng. & Therapeutics, HuntingtonBch http://www.ibclifesciences.com/AntibodyEng/overview.xml
=> Total Revs May06-Jul14: $108.0mm/Avid + $24.1mm/Govt + $2.1mm/Lic. = $134.2mm
This large post has 3 sections:
I. 9-9-14 Q1/FY15 Qtly. Earnings Conf. Call TRANSCRIPT (q/e 7-31-14)
II. 9-9-14 PPHM Press Release: Q1/FY15 Earnings & Developments
III. Updated Table of Avid Revenues By Quarter (May’06-Current)
…Recall: Peregrine’s FY runs May-Apr, so FY’15 = May’14-Apr’15.
((( Orig. transcript from SeekingAlpha.com [ http://tinyurl.com/qc2qqa4 ], with numerous corrections made. )))
Link to webcast replay:
http://ir.peregrineinc.com/events.cfm => http://www.media-server.com/m/p/p5ihgqcu
FULL TRANSCRIPT…
9-9-2014 Q1 FY’15 Earnings Conf. Call (q/e 7-31-14)
WELCOME & FWD-LOOKING STATEMENTS: Chris Keenan (IR) http://www.peregrineinc.com
Speakers: Steve King, Jeff Hutchins, Joe Shan, Paul Lytle; Q&A session.
CEO STEVE KING – OPENING COMMENTS:
Thank you for participating in this afternoon’s call. We are continuing to execute and deliver based on the plans we laid out on our last quarterly call. We continued the expected global expansion of the bavituximab SUNRISE Phase III trial that now has over 130 worldwide clinical sites, nearing the total number of sites we expected to have involved in the study in order to keep us on track to meet our enrollment goals.
In addition, we saw the completion of enrollment in an important Liver Cancer study combining bavituximab with sorafenib. And, we expect to have data from this study as well as data from a Front-Line NSCLC study over the coming months. Joe will update you on clinical developments during his prepared remarks.
In addition to the clinical trials, many of which have also have translational data points built in to tie together pre-clinical data with the clinic, we have also continued to build momentum in our pre-clinical collaborations which now number in the dozens. We are evaluating new combinations & dosing strategies combining bavituximab with chemotherapy, radiation, and immune-oncology approaches, including those targeting CTLA-4, PD-1 as well as other downstream immune checkpoints. In addition, we are evaluating combinations with other immune based approaches including vaccines and adjuvants. It is important to have a robust collaboration program so that we can identify those combinations & approaches that truly stand out and thus support advancing to the clinic. Data from these studies will also play a critical role in our ongoing discussions with potential corporate partners. We have already started to see the fruits of these collaborations with very encouraging results in preclinical models of Melanoma, Colon Cancer, and most recently Breast Cancer when combining bavituximab with other immune checkpoint inhibitors.
Perhaps the most exciting thing about this data when taken as a whole is that the data are remarkably consistent with respect to increases in mature T-cells, and in particular CD8, both positive signals of immune activation. In the studies like these that answer key questions and allow us to formulate the most ideal clinical pathway forward. We expect to be able to share this data and more over the coming months at key scientific and medical conferences. Jeff will update you on the collaboration front during his prepared remarks.
This is an exciting time in the battle against cancer with new approval for immune-oncology agents such as Ono Pharm. & Merck’s anti-PD-1 antibodies which recently received regulatory approvals [nivolumab/BMS&Ono & Keytruda=pembrolizumab/Merck]. This opens the door for new clinical development avenues for novel bavituximab combinations that are already supported by preclinical data we have generated in a number of solid tumor animal models. We are in a unique position with a late stage clinical program for an antibody with a unique immunotherapy mechanism of action that appears to be an ideal fit for combination with approved immunotherapy treatments such as the anti-PD-1 antibodies - truly an exciting time for cancer treatment options and for the bavituximab program.
In addition of these development efforts, we also continue to see a solid performance from our wholly-owned manufacturing subsidiary Avid Bioservices that, coming off a record year, has already begun 2015 strongly with $5.5mm in 3rd-party contract revenue for the quarter and the expansion of our client base. Paul Lytle will update you on the Avid developments as well as the rest of the financial highlights during his discussion.
In summary, we have continued to make significant progress across all aspects of the company, that has us positioned for data presentations, continued revenue performance, and getting closer to the data from the pivotal SUNRISE trial as well as the ongoing expansion immune-oncology development program. With that I will now turn the call over to Jeff, to discuss pre-clinical development efforts.
JEFF HUTCHINS (VP/Preclinical Research):
The purpose of our broad, highly collaborative pre-clinical approach is to guide the direction of future clinical trials in this rapidly evolving IO space. Our goal is to identify the most robust immune-oncology combinations that unlock the full capacity of anti-tumor response without systemic immune-related side effects. The breadth of this approach speaks to the wisdom of working directly with highly recognized individual experts in this space. We are now seeing & presenting the fruits of these efforts and yielding encouraging statistically significant results to date. And most importantly, building a pre-clinical rational to help guide our future clinical trial designs. To that end, we’ve shown this progress of our immune-oncology program, with data recently presented at ImVacS, the “Annual Immunotherapies & Vaccine Summit”, highlighting the combination of a PS-Targeting antibody equivalent to bavituximab and an anti-PD-1 antibody in an immune competent animal model of breast cancer. Results show statically significant tumor suppression, while also demonstrating a significant increase in tumor fighting CD8 T-cells that are into the tumor like environment, compared to an anti PD-1 antibody alone.
[ BAVI MOA 8-11-14: PPHM/VP Dr. Jeff Hutchins’ presentation at ImVacS "Immunotherapies & Vaccine Summit", Boston - PR: http://tinyurl.com/lpjy3u7 ; PDF(31 Slides): http://tinyurl.com/oueldme ]
Additional data from this study, as well as a follow-up data from our Melanoma study, will be presented at the 29th Annual Meeting for the Society of Immunotherapy & Cancer SITC to be held in November [Nov6-9 2014 http://www.eventscribe.com/2014/sitc ]. As Steve mentioned these data align with what we have seen in models of colon & melanoma, and as such warrant expanded investigation with further immune checkpoint inhibitors, agonists, adjuvants, and therapeutic vaccines. With that I’ll turn the call over to Joe to update you on our clinical programs.
JOE SHAN (VP/Clin.&Reg. Affairs) – CLINICAL TRIALS:
Let me start by giving a quick update on our Phase III lung cancer trial, SUNRISE. With nearly 140 clinical sites now opened for enrollment, planned site activation is nearing completion and we remain on track to complete enrollment of approx. 600 patients by the end of calendar year 2015, with 2 planned interim analyses that are event-driven. As I mentioned during our call just a couple of months ago, in conjunction with site activation & enrollment activities, we are implementing an ongoing site engagement and educational initiative for investigators and thought leaders in conjunction with scientific & medical conferences, including the upcoming European Society for Medical Oncology, ESMO 2014 Congress, later this month. [Sept 26-30/Madrid http://www.esmo.org/Conferences/ESMO-2014-Congress ]
Now turning some of our other pipeline indications, starting with Liver Cancer. Today we announce the completion of enrollment of 38 patients in the Phase II part of a Phase I/II IST evaluating bavituximab in combination with sorafenib in patients with Advanced Hepatocellular [Liver] carcinoma. We are continued to be encouraged by the updates from the principal investor, Dr. Adam Yopp of the Univ. of Texas SW Medical Center in Dallas, and we look forward to his presentation of the full clinical results at a future conference. Meanwhile, as part this trial, we have been able to generate translational data showing immune changes in patient tumor samples which are consistent with the immuno-modulating mechanism observed in preclinical models. These data will be presented at the 29th Annual Meeting of the Society for the Immunotherapy of Cancer conference [SITC] at the beginning of November. [Nov6-9 2014 http://www.eventscribe.com/2014/sitc ]
Today we also announced that data from the Phase Ib IST evaluating bavituximab in combination with carboplatin+pemetrexed in 25 patients with previously untreated Stage IV NSCLC has been accepted for presentation as at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology (MSTO) at the end of October. [Oct30-Nov1, Sponsors: ASTRO, ASCO, IASLC, Univ. of Chicago http://www.thoracicsymposium.org ]
And lastly, as you’ve just heard from Jeff, we continued to generate preclinical data to inform clinical development about bavituximab in Breast Cancer. We are also looking forward to the manuscript publication of the final result of the Phase I trial which combines bavituximab & paclitaxel in the near future. Recall preliminary results demonstrated an encouraging 85% tumor response rate in patients with HER2-metastatic breast cancer. So as you can see, several ISTs are expected to readout over the next few months, and these clinical results together with our expanding preclinical I-O pipeline support not only extending the potential combination uses of bavituximab in the clinic, but also advancing clinical development in Breast Cancer and Liver Cancer as resources permit. And with that I’ll turn the call over to Paul.
CFO Paul Lytle:
Now turning to our financials, it’s important to note that we continue to closely manage our operations in line with our cap position while balancing our various sources of capital. One important source of capital is derived from our contract mfg. business where we generated $5.5mm in revenue this qtr and we anticipate that contract mfg. revenue will be $19-23mm for the full FY [May’14-Apr’15] as mentioned on the previous call. In addition, we supplemented our cap position this qtr with $9.5mm in net proceeds received from the sale of Series E Preferred Stock sold at $25/sh. This funding vehicle represents less-dilutive capital to the company since its convertible into common shares at a conv. price of $3/sh. With these addl. sources of capital and taking into consideration our statement of operations, we ended the qtr with over $73mm in cash, and based on our current projections this represents sufficient capital to execute on our business plans for at least the next 12-mos. Now turning to our statement of operations, we saw an expected increase in our net loss this qtr as we continue to execute on our #1 R&D goal, advancing the Phase III SUNRISE trial. As we invested in the Phase III trial, R&D spending increased to approx. $10mm this qtr, thereby increasing our net loss to approx. $13mm. As a result, we saw a similar increase in our cash burn from operations to $11mm this qtr, representing our net loss minus non-cash expenses. Our financial goals are centered on maintaining a solid cash position and investing these proceeds into our novel, immune-oncology program led by bavituximab and the Phase III SUNRISE trial. We will continue to closely manage our operations in line with our cash position while balancing the various sources of capital.
Q&A: [14:36 mark]
1. Joe Pantginis – Roth Capital Partners: [ http://www.roth.com & https://roth2.bluematrix.com/docs/pdf/BLUE.pdf ]
JP: ”With regard to the site openings, that’s great progress, about 130 sites you said, and enrollment trends that you’ve been seeing - how well have they been tracking with your projections before the study started?”
SK: We haven’t given a lot of addl. details other than the fact that the trial is getting up to close to full steam as far as number of sites involved in the study, and that’s most critical of course because once you get all the sites up running and that’s when you reach the maximum enrollment rates. So at this point, we’re simply saying that we are on track for the initial estimate of less than a 2-year enrollment and if we start to deviate significantly one way or another from that, we’ll let everyone know, but at this point we feel comfortable that we are on track.
JP: ”Okay that’s fair and then with regard to Joe mentioning maybe at SITC we would be seeing some translational data from the Liver Cancer study, so I was just wondering if there is any potential teaser there and then the next layer for that question is with regard to your ongoing business dev. activities, have you seen any change in the tenor of those discussions with the recent approval of Keytruda [Merck’s Anti-PD-1 drug pembrolizumab, aka MK-3475, for Adv. Melanoma]”
SK: Sure, I can get things started and then turn it over to Jeff & Joe for a little bit more color as far as the translational work goes, but, yes, there has been an awful lot of interest spurred by the recent regulatory success of the Anti-PD-1 antibodies and moving those into the marketplace, that clearly opens up some very nice opportunities down the road for new clinical trials that can be run, but also in ways to best use bavituximab, because we really feel like we are in a unique position with a late-stage immune-oncology agent that really looks like it should be a perfect fit with these agents that are now coming on to the market from a combination standpoint. I think that’s definitely heated up the discussions, as well as all the translational data and other study-related data from the preclinical models that we've been running. As far as kind of a teaser, I think we've said right from the beginning that one of the things we've been looking for out of the number of the IST’s are really the correlative data that goes along with the animal studies we've completed showing basically the symptomatic changes in the profile of the immune cells that are present in the tumor microenvironment and more broadly in the animals themselves, so that’s kind of data in general that of course we’re looking to present. I’ll let Jeff or Joe add a little bit to that.
Jeff Hutchins: As Joe said, really the teaser is that we are seeing some consistency between what we first identified in the animal models as this increase in CD8 positive T-cells translating quite nicely with the liver samples.
Joe Shan: Yes, I think the totality of the immune changes, of course the CD8 changes are interesting, but we basically are recapitulating all of the pre-clinical steps within the immune system changes within the tumor. So it’s more than just CD4, CD8, T-regs for example. There is a lot of information on it we’ll be sharing.
SK: To expand on that, obviously the ability to then correlate this with patient outcomes, and this is all very important data from a partnering standpoint also, and this is exactly the kind of data that is driving a lot of interest we are seeing now from both partnering standpoint as well as from collaborative standpoint. In particular, with data like Liver Cancer, as was stated before, our goal is actually with partnering. Liver Cancer is a huge indication throughout the Asia-Pacific region, so that’s clearly a very attractive next potential target outside of NSCLC for some of those territories.
2. Roy Buchanan for Charles Duncan – Piper Jaffray [http://www.piperjaffray.com – 3-5-13 Initiates PPHM: http://tinyurl.com/bxhntk3 ]
RB: “I wonder if you can go into a bit more detail about the combo programs with vaccines & adjuvants, specifics around which vaccines & adjuvants, and maybe what we might see over the next 12-mos.”
Jeff Hutchins: We can go back quite a ways to published data where actually radiotherapy works quite well as an adjuvant and a vaccine if you will. So, what we are trying to do is go back and really revisit some of those early observations now that we understand how well bavituximab does to re-polarize those myeloid cells that are so important in vaccine presentation and so forth. So, you really could go through and re-evaluate some of the recent failures in clinical vaccines and ask the question now, if you re-polarize and change the local micro environment around the tumor, will these vaccine now be much more effective? That really summaries our excitement around this area.
RB: ”Is there any specific I guess platform or technology that you are looking at service dendritic cell or…”
Jeff Hutchins: Well, as Steve mentioned, we have a number of collaborations that really cover all these areas and it’s really a focus in a sense to make sure we are hitting the right combination to put really, if you will, put the immune system back together to respond appropriately to the tumor.
SK: Yes, and our goal is to look at all the different areas so which haven’t been now public with what the collaborations are, but goal is to touch on the dendritic cell vaccines as well as antigen-based vaccines, where we see some promising results and things we can build on from this growing body of evidence of the immune system changes we are seeing with the changes in the tumor-associated macrophages as well as some of the other immune components.
RB: ”That makes sense… do you have any expectations on when we might see the first interim for SUNRISE?”
Joe Shan: It is really impossible to predict. Obviously it’s event-driven, so at this point we’re not trying to project that. We will focus on enrolling the patients and then… you know.
SK: It’s obviously event-driven, so there are other variables besides just the enrollment patterns themselves, and just how the patients are doing, and what have you.
3. George Zavoico (MLV & Co.): http://www.mlvco.com
GZ: ”Regarding the breast cancer data, the last time this data was presented, there were 4 patients still on therapy. And, you said in your press release that the results might be revealed in the publication. Do you anticipate that happening before an update at a medical conference which is sort of the usual sequence of events?”
Joe Shan: Not necessarily, the investigator has prepared a manuscript, which we expect to be submitted for publication shortly. It’s going to contain obviously the results previously, but in a more fuller description, and then we’ll have some updates on the clinical endpoints like progression-free survival for example.
GZ: ”So there will be new date obviously then.”
Joe Shan: Yes.
GZ: ”With regard to patents, bavituximab is an immune checkpoint inhibitor, sort of a new look to the antibody – that wasn’t how it was originally conceived. Does that present an opportunity for you to file the new patents for method of use in combination with immune checkpoint inhibitors or how does that effect or improve your patent portfolio on bavituximab or PS-Targeting antibodies if at all?”
SK: Obviously as we've gone through the development stages we've filed additional patents that build on the original patents, particularly with different combinations, as you were saying, and new ways to look at how the drug is used, and so we think that those certainly help broadened the estate, certainly some of the combinations are covered well beyond the original patents that cover things like the antibody and the targeted cell. Yes, we are always continuing to evaluate new inventions, the impacts of those on the overall portfolio, the length of time for coverage, and we feel pretty comfortable that at this point we have everything pretty much covered from what we currently have in the clinic. Again, that’s an ongoing process and it never stops and we have number of committees that do nothing but simply look at those sort of aspects of the development of the drug.
GZ: ”So, we can anticipate perhaps some extensions in the patent life here then, for certain combinations, it sounds like. With regard to the budget, Paul, you outlined how long you expect the cash to last. What exactly is included in the budget, because what you’re implying with all the results that are coming out in breast & liver, it seems that it would behoove you to try and get into addl. trials in other indications as quickly as possible. With liver results coming out, the breast results coming out, it’s quite possible that the next trial could start next year if you find the right partners or if you just decided to go on your own. If there any of those new indications included in your budget?”
Paul Lytle: That’s a very good question. Our goal right now is really executing on the Phase III trial, the SUNRISE trail - obviously that’s currently in our budget. When we talk about having sufficient cash resources to fund our operation for at least the next 12-mos., that’s a conservative estimate that so we really mean at least the next 12-mos. when we project out 12-mos. or so in terms of providing that type of forecast. So, this is a conservative-type estimate when we put out our projections. In terms of new indications, you hit the target. We do want to start some new collaborations - that could come through other funding opportunities; that could come through partnering opportunities, and other avenues. So, we are definitely going to pursue that. We are as excited as you to initiate some of these new studies, and we just want to make sure first and foremost we can execute on the Phase III trial first and then as new opportunities come to fruition we can expand our R&D pipeline to include some of those other things.
SK: Just to extend on that, the one of the points Paul made on partnering is very important because really at this point bringing on board a partner may help us to complete executing the clinical trial, like bringing in capital, but from an operations standpoint, the trial is already underway and basically is on track. So, when we think about partnering we’re really looking at expanding into some of these new indications, and clearly Breast Cancer & Liver Cancer are right now are at the top of the list, based on the totality of the preclinical & clinical data we've generated to-date. We view that as a great way to move the program forward to expand it, and really then also be able to cover commercialization in various territories.
GZ: ”My final question is kind of philosophical in the sense that the immune checkpoint space has been very exciting lately and you have made an effort to educate everyone about the potential of bavituximab in that space, and yet if you look at your market capitalization since about April, it really hasn’t moved very much and apart from the spike in March, it really hasn’t moved much since January. So, what do you attribute, if you wish to comment on it, that sort of plateau performance, and what do you think you can do to help change that perception?”
SK: We are approaching this on a number of different fronts. First is getting out and really kind of telling the story to as many funds and institutions within the investment space. I think also the kind of collaborations that we've entered into and the presentation of clinical data at these key medical & scientific conferences is also critical, because up to the last few years we typically may not have been present that most of the major immunotherapy-type conferences, whereas now, clearly, we are constant figures at these conferences and presenting data. I think maybe even most importantly is that our data is very consistent with what people are showing with other test systems. So, it really is resonating with people in a way it hasn’t in the past. But, it’s a ground effort – it’s publications, presentations. And then, of course, clinical data will eventually trump all that, and that’s the reason that executing on the Phase III SUNRISE trial is so important as a backbone to getting the recognition for this program. It’s just going to be continuing to execute, be on the road. I think, the more the word gets out there, we think the more we’ll be clearly in the middle of the space. As I said in the prepared remarks, to me we’re in a really unique position because, while there’s a lot of interest in immunotherapy, there’s not many that are in the middle of their pivotal Phase III study like we are. We view that is a real benefit and I think something it will drive a lot of interest because once a drug’s on the market now, of course, it opens up all kind of avenues for combinations and others ways to use the drug. We’re really looking forward to continuing to execute on that and take advantage of sort of that position being more advanced than a lot of the other immune checkpoints at this point.
MR. KING’S CLOSING COMMENTS:
I’d like to thank you all again for participating in today’s call. We have begun the FY well-positioned with clinical data expected in the near-term from multiple trials, as well as pre-clinical data from our immune-oncology program. As we said earlier, we believe that we are in a unique position and feel this is an important time for the company and its programs as we work to understand the full potential of this novel immunotherapy. So again, thank you and we look forward to updating you with this progress throughout the quarter.
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9-9-14 PR: Peregrine Pharmaceuticals Reports First Quarter FY2015 Financial Results and Recent Developments
SUNRISE Phase III Lung Cancer Trial Operational at Over 130 Sites Worldwide
Preclinical Data in Breast Cancer Supports Immuno-Oncology Combinations With Bavituximab
Clinical Data From Liver, Breast and Front-Line Non-Small Lung Cancer Trials Anticipated in the Coming Months
Enrollment Complete in Bavituximab Plus Sorafenib Investigator-Sponsored Trial in Patients With Advanced Liver Cancer
Company Delivers Solid First Quarter With $5.5 Million in Contract Manufacturing Revenue
TUSTIN, CA, 9/9/14: Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM) (NASDAQ: PPHMP), a biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment and diagnosis of cancer, today announced financial results for the first quarter of fiscal year (FY) 2015 ended July 31, 2014 and provided an update on its advancing clinical pipeline led by its investigational immuno-oncology candidate bavituximab and reviewed other corporate developments.
"We continued to advance the bavituximab clinical program on multiple fronts with the major focus on executing the SUNRISE Phase III trial which is progressing well with the initiation of new global clinical sites bringing the total participating sites to over 130. In addition, our collaborator at UT Southwestern recently completed enrollment in an important liver cancer study opening the door for data from this study as well as other bavituximab clinical trials to be presented over the coming months," said Steven W. King, president and chief executive officer of Peregrine. "In addition to the clinical trial activities, we have a robust preclinical collaboration program evaluating new combinations and dosing strategies combining bavituximab with chemotherapy, radiation and immune-oncology approaches that are constantly yielding important data that will help guide and expand the clinical program."
BAVITUXIMAB ONCOLOGY PROGRAM HIGHLIGHTS
Lead Indication in Second-Line Non-Small Cell Lung Cancer:
The company continues to actively open 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, 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 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 130 sites worldwide have been initiated in this pivotal trial.
For additional information about the SUNRISE trial please visit www.sunrisetrial.com or ClinicalTrials.gov using the Identifier 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. Final 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 are anticipated to be published in a manuscript in the near future.
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) has completed enrollment of the Phase II portion and data from this trial are expected to be presented at an upcoming conference. "The Phase II portion of this trial has completed enrollment with a number of patients currently on treatment, the longest of whom has been on treatment for 18 months," said Adam Yopp, M.D., Assistant Professor of Surgery at the University of Texas Southwestern Medical Center's Simmons Cancer Center. "While the results from this trial are preliminary, I believe they are promising. I am excited about this potential combination given the new understandings about bavituximab's mechanism and I look forward to sharing the full set of data from this Phase II trial at a future scientific conference."
• A Phase Ib IST evaluating bavituximab in combination with carboplatin and pemetrexed in up to 25 patients with previously untreated Stage IV NSCLC has completed enrollment with interim data accepted for presentation at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology to be held October 30 - November 1, 2014.
• A Phase I IST evaluating bavituximab in combination with capecitabine and radiation therapy in up to 18 patients with Stage II or III rectal adenocarcinoma is open for patient enrollment.
• A Phase Ib IST evaluating bavituximab in combination with Bristol-Myers Squibb's ipilimumab (Yervoy®) in up to 24 patients with advanced melanoma is open for patient enrollment.
BAVITUXIMAB IMMUNO-ONCOLOGY DEVELOPMENT PROGRAM
This program continues to explore the potential of combining bavituximab with other immunotherapies, experimental immuno-oncology drugs including checkpoint inhibitors, as well as vaccines. Recently, data presented at ImVacS, The Annual Immunotherapies and Vaccine Summit shows that the combination of a PS-targeting antibody equivalent to bavituximab administered with an anti-PD-1 antibody displays statistically significant tumor growth suppression while also demonstrating a significant increase in tumor-fighting T-cells into the tumor microenvironment compared to anti-PD-1 antibody treatment alone in an immune competent animal model of breast cancer.
Data from the company's immuno-oncology program, as well as clinical translational data aimed at assessing and measuring changes in immune response pre- and post-treatment from the liver cancer IST will be the subject of presentations at the 29th Annual Meeting of the Society for the Immunotherapy of Cancer (SITC) to be held November 6-9, 2014. [SITC 2014: http://www.eventscribe.com/2014/sitc ]
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 started the fiscal year on a strong note generating $5.5 million in contract manufacturing revenue for the first quarter," said Paul Lytle, chief financial officer of Peregrine. "In addition, Avid has been successful in expanding its client roster while also continuing to evaluate manufacturing options that would create new manufacturing capacity for the potential commercial launch of bavituximab in addition to providing Avid with increased capacity for its clients."
FINANCIAL RESULTS
Total revenues for the first quarter of FY 2015 were $5,496,000, compared to $4,688,000 for the same quarter of the prior fiscal year. The increase was primarily attributed to an increase in contract manufacturing revenue generated from Avid Bioservices.
Contract manufacturing revenue from Avid's clinical and commercial biomanufacturing services provided to its third-party clients for the first quarter FY 2015 were $5,496,000, compared to $4,581,000 for the same quarter of the prior fiscal year. Peregrine expects contract manufacturing revenue 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 first quarter of FY 2015 were $18,667,000, compared to $12,308,000 in the first quarter of FY 2014. This increase was primarily attributable to current quarter increases in research and development expenses associated with the SUNRISE Phase III trial and incremental increases in selling, general and administrative expenses. For the first quarter FY 2015, research and development expenses were $10,201,000, compared to $5,304,000 for the first quarter of FY 2014. For the first quarter FY 2015, selling, general and administrative expenses were $4,883,000, compared to $4,334,000 for the first quarter of FY 2014.
Peregrine's consolidated net loss attributable to common stockholders was $14,157,000, or $0.08 per share, for the first quarter of FY 2015, compared to a net loss attributable to common stockholders of $7,600,000, or $0.05 per share, for the same quarter of the prior year.
Peregrine reported $73,256,000 in cash and cash equivalents as of July 31, 2014 compared to $77,490,000 at fiscal year ended April 30, 2014.
More detailed financial information and analysis may be found in Peregrine's Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.
CONFERENCE CALL
Peregrine will host a conference call and webcast this afternoon, September 9, 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 September 16, 2014 by calling (855) 859-2056, or (404) 537-3406 and using passcode 94131393.
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.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
THREE MONTHS ENDED
July 31, 2014 July 31, 2013
Unaudited Unaudited
REVENUES:
Contract manufacturing revenue $ 5,496,000 $ 4,581,000
License revenue - 107,000
Total revenues 5,496,000 4,688,000
COSTS AND EXPENSES:
Cost of contract manufacturing 3,583,000 2,670,000
Research and development 10,201,000 5,304,000
Selling, general and administrative 4,883,000 4,334,000
Total costs and expenses 18,667,000 12,308,000
LOSS FROM OPERATIONS (13,171,000 ) (7,620,000 )
OTHER INCOME (EXPENSE):
Interest and other income 42,000 21,000
Interest and other expense - (1,000 )
NET LOSS $ (13,129,000 ) $ (7,600,000 )
COMPREHENSIVE LOSS $ (13,129,000 ) $ (7,600,000 )
Series E preferred stock accumulated dividends (1,028,000 ) -
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS $ (14,157,000 ) $ (7,600,000 )
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING
Basic and diluted 179,118,255 149,393,630
BASIC AND DILUTED LOSS PER COMMON SHARE $ (0.08 ) $ (0.05 )
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
JULY 31,
2014 APRIL 30,
2014
Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 73,256,000 $ 77,490,000
Trade and other receivables, net 1,391,000 1,332,000
Inventories 5,998,000 5,530,000
Prepaid expenses and other current assets, net 883,000 1,419,000
Total current assets 81,528,000 85,771,000
Property and equipment, net 3,647,000 2,447,000
Other assets 2,432,000 2,327,000
TOTAL ASSETS $ 87,607,000 $ 90,545,000
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 5,080,000 $ 2,434,000
Accrued clinical trial and related fees 1,887,000 4,433,000
Accrued payroll and related costs 2,654,000 3,837,000
Deferred revenue, current portion 4,670,000 5,241,000
Customer deposits 6,226,000 5,760,000
Other current liabilities 606,000 502,000
Total current liabilities 21,123,000 22,207,000
Deferred revenue, less current portion - 292,000
Other long-term liabilities 892,000 347,000
Commitments and contingencies
STOCKHOLDERS' EQUITY:
Preferred stock-$0.001 par value; authorized 5,000,000 shares; issued and outstanding 1,175,000 and 775,000, respectively
1,000
1,000
Common stock-$0.001 par value; authorized 325,000,000 shares; issued and outstanding - 179,216,032 and 178,871,164, respectively
179,000
179,000
Additional paid-in capital 481,807,000 470,785,000
Accumulated deficit (416,395,000 ) (403,266,000 )
Total stockholders' equity 65,592,000 67,699,000
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 87,607,000 $ 90,545,000
Contact: Christopher Keenan, Peregrine Pharmaceuticals, Inc., (800) 987-8256, info@peregrineinc.com
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[ From 10-Q header: “As of Sept. 5, 2014, there were 179,505,424 shares of issuer’s common stock
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Latest 10K 4-30-14 iss. 7-14-14: http://tinyurl.com/mhva3k3 PR: http://tinyurl.com/o2e4a4g (Cash 4-30-14=$77.5mm)
Latest 10Q 7-31-14 iss. 9-9-14 http://tinyurl.com/phw6dkp PR: http://tinyurl.com/ktrfswj (Cash 7-31-14=$73.3mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
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Updated PPHM REVS-BY-QTR TABLE, now thru FY15/Q1 (qe 7-31-14), per the 7-31-14 10-Q (http://tinyurl.com/phw6dkp ) issued 9-9-14. Deferred-Revs at 7-31-14, going fwd into FY’15/Q2 (q/e 10-31-14), total $4.7mm, down from the $5.2mm of Deferred-Revs at 4-30-14 that drove into FY’15/Q1.
Total Revs since May’06: ($108.0mm/Avid + $24.1mm/Govt + $2.1mm/Lic.) = $134.2mm
Avid’s Gross-Profit over last 4 qtrs: $9.2mm on revs of $23.2mm (GM% = 40%)
==> Recall, Avid Rev$ from Gov’t DTRA Contract work (6/30/08 – 4/15/11, totaling $24.15mm), went into GOVT-REVS, not AVID-REVS, in the Financials.
Avid’s website: http://www.avidbio.com
AVID PROFITABILITY (GROSS*) BY QTR:
QTR Avid-Rev$ CostofMfg$ Gross-Profit$ GM%
FY13Q1 7-31-12 4,135,000 2,024,000 2,111,000 51%
FY13Q2 10-31-12 6,061,000 3,703,000 2,358,000 39%
FY13Q3 1-31-13 6,961,000 3,651,000 3,310,000 47%
FY13Q4 4-30-13 4,176,000 3,217,000 959,000 23%
FY13 TOTAL: 21,333,000 12,595,000 8,738,000 41%
FY14Q1 7-31-13 4,581,000 2,670,000 1,911,000 42%
FY14Q2 10-31-13 7,354,000 4,195,000 3,159,000 43%
FY14Q3 1-31-14 3,885,000 2,416,000 1,469,000 38%
FY14Q4 4-30-14 6,474,000 3,829,000 2,645,000 41%
FY14 TOTAL: 22,294,000 13,110,000 9,184,000 41%
FY15Q1 7-31-14 5,496,000 3,583,000 1,913,000 35%
*Avid Net-Profit (ie, incl. Selling, G&A) not split out from PPHM-Corp. in the financials.
.
PPHM REVENUES (in thousands) DEFERRED
-------REVENUES------- REVENUES INVEN-
Quarter Avid Govt Lic. TOTAL Avid Govt TORIES
FY07Q1 7-31-06 398 0 23 421 317 0 971
FY07Q2 10-31-06 636 0 48 684 1388 0 1899
FY07Q3 1-31-07 347 0 16 363 2202 0 1325
FY07Q4 4-30-07 2111 0 129 2240 1060 0 1916
FY08Q1 7-31-07 1621 0 4 1625 1820 0 2363
FY08Q2 10-31-07 1863 0 29 1892 1338 0 3500
FY08Q3 1-31-08 1662 0 13 1675 1434 0 2394
FY08Q4 4-30-08 751 0 150 901 2196 0 2900
FY09Q1 7-31-08 1193 324 0 1517 4021 980 4628
FY09Q2 10-31-08 983 958 0 1941 6472 1701 6700
FY09Q3 1-31-09 5778 1048 0 6826 4805 3262 5547
FY09Q4 4-30-09 5009 2683 175 7867 3776 3871 4707
FY10Q1 7-31-09 2070 4671 9 6750 5755 2332 6177
FY10Q2 10-31-09 5308 1510 78 6896 4260 3989 5850
FY10Q3 1-31-10 2945 6854 78 9877 3052 76 3861
FY10Q4 4-30-10 2881 1461 78 4420 2406 78 3123
FY11Q1 7-31-10 983 2111 115 3209 3719 47 4692
FY11Q2 10-31-10 3627 966 78 4671 2447 35 3555
FY11Q3 1-31-11 1922 882 79 2883 4300 40 3915
FY11Q4 4-30-11 1970 681 78 2729 5617 0 5284
FY12Q1 7-31-11 5439 0 216 5655 4145 0 4481
FY12Q2 10-31-11 4154 0 78 4232 2012 0 3178
FY12Q3 1-31-12 3203 0 78 3281 2552 0 2722
FY12Q4 4-30-12 1987 0 78 2065 3651 0 3611
FY13Q1 7-31-12 4135 0 116 4251 6056 0 5744
FY13Q2 10-31-12 6061 0 78 6139 6221 0 5426
FY13Q3 1-31-13 6961 0 78 7039 5061 0 4635
FY13Q4 4-30-13 4176 0 78 4254 4171 0 4339
FY14Q1 7-31-13 4581 0 107 4688 4164 0 5679
FY14Q2 10-31-13 7354 0 0 7354 3468 0 4033
FY14Q3 1-31-14 3885 0 0 3885 4329 0 5224
FY14Q4 4-30-14 6474 0 0 6474 5241 0 5530
FY15Q1 7-31-14 5496 0 0 5496 4670 0 5998
Totals: 107964 24149 2087 134200 <=since5/1/2006
.
TOTAL REV’s BY YEAR (Avid+Gov’t+Lic):
FY04 4-30-04 3,314 …Avid(CMO)= 3,039 (Avid-Revs don’t incl. Govt-SVCS)
FY05 4-30-05 4,959 …Avid(CMO)= 4,684
FY06 4-30-06 3,193 …Avid(CMO)= 3,005
FY07 4-30-07 3,708 …Avid(CMO)= 3,492
FY08 4-30-08 6,093 …Avid(CMO)= 5,897
FY09 4-30-09 18,151 …Avid(CMO)= 12,963
FY10 4-30-10 27,943 …Avid(CMO)= 13,204
FY11 4-30-11 13,492 …Avid(CMO)= 8,502
FY12 4-30-12 15,233 …Avid(CMO)= 14,783
FY13 4-30-13 21,683 …Avid(CMO)= 21,333
FY14 4-30-14 22,401 …Avid(CMO)= 22,294
...Total Gov’t Revs from 7-2008 inception thru FY11Q1(Apr’11): $24.15mm
.
AVID “Total Services”:
AVID OUTPUT$ 3rd-PARTY + PEREGRINE = TOTAL-OUTPUT$
FY09 4-30-09 13mm 10mm $23mm #
FY10 4-30-10 13mm 17mm $30mm #
FY11 4-30-11 9mm 11mm $20mm @
FY12 4-30-12 15mm 11mm $26mm @
FY13 4-30-13 21mm ~10mm ~$31mm ^
LTM ended 1/2010 3rd/$15.3mm + Govt/$8.3mm + PPHM/$8.8mm = $32.4mm *
@SKing 3-18-2013 RothOC/DanaPT (Slide21) http://tinyurl.com/cebtwen
#SKing 7-12-2012 JMP/NYC Conf. (Slide27) http://tinyurl.com/csdclwb
*SKing 3-17-2010 RothOC/DanaPT Conf. (Slide18) http://tinyurl.com/ye9v7jq
^PLytle 7-11-2013 Qtly-CC “Avid did ~$10mm in equivalent services for Peregrine in FY13, which doesn’t get reflected into the fin. statements, it's eliminated in consolidation.”
.
PPHM’S QTLY. NET LOSS BY QTR:
FY08Q1 7-31-07 4,656,000
FY08Q2 10-31-07 6,207,000
FY08Q3 1-31-08 6,154,000
FY08Q4 4-30-08 6,159,000
FY09Q1 7-31-08 5,086,000
FY09Q2 10-31-08 4,497,000
FY09Q3 1-31-09 3,332,000
FY09Q4 4-30-09 3,609,000
FY10Q1 7-31-09 2,428,000
FY10Q2 10-31-09 2,787,000
FY10Q3 1-31-10 1,538,000
FY10Q4 4-30-10 7,741,000
FY11Q1 7-31-10 7,695,000
FY11Q2 10-31-10 7,513,000
FY11Q3 1-31-11 8,929,000
FY11Q4 4-30-11 10,014,000
FY12Q1 7-31-11 8,092,000
FY12Q2 10-31-11 12,055,000
FY12Q3 1-31-12 11,090,000
FY12Q4 4-30-12 10,882,000
FY13Q1 7-31-12 7,664,000
FY13Q2 10-31-12 8,753,000
FY13Q3 1-31-13 4,914,000
FY13Q4 4-30-13 8,449,000
FY14Q1 7-31-13 7,600,000
FY14Q2 10-31-13 7,790,000
FY14Q3 1-31-14 9,724,000
FY14Q4 4-30-14 10,248,000
FY15Q1 7-31-14 13,129,000
.
= = = = = = =
OPER. CASH BURNS* BY QTR(FROM THE 10-Q/K’S):
FY10Q1 7-31-09 2,024,000 (from 10Q pg.25)
FY10Q2 10-31-09 2,351,000 (Q1+Q2: 4,375,000 pg.28)
FY10Q3 1-31-10 1,158,000 (Q1+Q2+Q3: 5,533,000 pg.30)
FY10Q4 4-30-10 6,375,000 (FY’10: 11,908,000 10K pg.58)
FY11Q1 7-31-10 6,567,000 (from 10Q pg.24)
FY11Q2 10-31-10 6,167,000 (Q1+Q2: $12,734,000 pg.25)
FY11Q3 1-31-11 7,736,000 (Q1+Q2+Q3: $20,470,000 pg.26)
FY11Q4 4-30-11 8,961,000 (FY’11: 29,431,000 10K pg.54)
FY12Q1 7-31-11 6,984,000 (from 10Q pg.25)
FY12Q2 10-31-11 11,668,000 (Q1+Q2: 18,652,000 pg.25)
FY12Q3 1-31-12 8,490,000 (Q1+Q2+Q3: 27,142,000 pg.25)
FY12Q4 4-30-12 11,265,000 (FY’12: 38,407,000 10K pg.55)
FY13Q1 7-31-12 6,742,000 (from 10Q pg.21)
FY13Q2 10-31-12 6,162,000 (Q1+Q2: 12,904,000 pg.23)
FY13Q3 1-31-13 3,597,000 (Q1+Q2+Q3: 16,501,000 pg.23)
FY13Q4 4-30-13 7,053,000 (FY’13: 23,554,000 10K pg.60)
FY14Q1 7-31-13 5,750,000 (from 10Q pg.23)
FY14Q2 10-31-13 5,834,000 (Q1+Q2: 11,584,000 10Q pg.24)
FY14Q3 1-31-14 7,875,000 (Q1+Q2+Q3: 19,459,000 10Q pg.26)
FY14Q4 4-30-14 8,706,000 (FY’14: (28,165,000 10K pg.55)
FY15Q1 7-31-14 11,076,000 (from 10Q pg.23)
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)
FY’15-Q1 = q/e 7-31-14 – rep. 9-9-14 Tue (after mkt)
= = = = = = = = = = = =
“Going Concern” statement ELIMINATED from 4-30-13 10-K issued 7-11-2013…
2012: 4-30-12 10-K iss. 7-16-12 http://tinyurl.com/79o57b2
Pg.68: “As more fully described in Note 2, the Company’s recurring losses from operations and recurring negative cash flows from operating activities raise substantial doubt about its ability to continue as a going concern.”
2013 & 2014 10-K's: http://tinyurl.com/p58jcbw & http://tinyurl.com/mhva3k3 ==> ((((NO GOING CONCERN STATEMENT INCLUDED.))))
CASH a/o 4-30-13: $35.2mm
CASH a/o 6-30-13: $42.6mm
CASH a/o 7-31-13: $41.6mm
CASH a/o 10-31-13: $44.4mm
CASH a/o 1-31-14: $63.2mm
CASH a/o 2-15-14: $79.7mm
CASH a/o 4-30-14: $77.5mm
CASH a/o 6-30-14: $78.3mm
CASH a/o 7-31-14: $73.3mm
= = = = = = = = = = 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 9-9-2014:
http://www.peregrineinc.com/images/stories/pdfs/sept-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
- - - - - - - -
Bavituximab MOA & Clinical Data: http://www.peregrineinc.com/pipeline/bavituximab-oncology.html
...Bavi Publications: http://www.peregrineinc.com/publications/publications.html
...Bavi Posters & Presentations: http://www.peregrineinc.com/publications/posters-and-presentations.html
Bavi MOA: Video (3:34) added ~3-2014 http://vimeo.com/87116642 "Bavituximab: A Novel Immunotherapy Candidate Targeting an Upstream Immune Checkpoint to Fight Cancer"
Bavi MOA: Video (1:33) on Bavi’s Immunotherapeutic MOA added to Youtube on 3-27-14 https://www.youtube.com/watch?v=Esewl35JD8s
BAVI MOA 8-11-14: PPHM/VP Dr. Jeff Hutchins’ presentation at ImVacS "Immunotherapies & Vaccine Summit", Boston - PR: http://tinyurl.com/lpjy3u7 ; PDF(31 Slides): http://tinyurl.com/oueldme
...MLV’s Dr. George Zavoico’s 8-27-14 report on Dr. Jeff Hutchins’ 8-11-14 ImVacS/Boston Bavi MOA presentation: http://tinyurl.com/l3tw63c
BAVI MOA 5-28-14: Dr. Rolf Brekken’s 47min CRI “Cancer Immunotherapy” webinar about Bavituximab as an Upstream/Global Immune Checkpoint Inhibitor – REPLAY: http://tinyurl.com/lxgftyx
. . .CRI=Cancer Research Institute (NYC – Supported by BMS): http://www.cancerresearch.org - Facebook: http://tinyurl.com/pbmhb2z , https://twitter.com/CancerResearch
. . .CRI launches “Answer to Cancer” (cancer immunotherapy) website http://www.theanswertocancer.org
. . .8-12-14: CRI adds Youtube links to the 5-28-14 CRI Immunotherapy webinar, incl. Dr. Brekken's talk "about Bavi and how it works against lung, liver, and other kinds of cancers" http://tinyurl.com/ps5h6h8
BAVI MOA 3-25-14: Dr. Rolf Brekken’s 40min talk at NYAS Lung Cancer Symposium http://tinyurl.com/lq9stnk (45 Slides)
. . .Dr.Brekken’s talk: “Antibody-mediated Inhibition of PS - A Novel Strategy for Immune Checkpoint Blockade” (the 5 speakers: Jessica Donington, Roy Herbst, Balazs Halmos, Suresh Ramalingam, Rolf Brekken)
BAVI MOA: 12-2013 Bavi’s Immunotherapeutic MOA overviewed by UTSW’s Brekken/Huang in Pan European Networks Jrnl. http://tinyurl.com/lnb46pq
BAVI MOA 11-9-13: Annual SITC (WashDC) – 2 posters about Bavi’s Immunostimulatory MOA http://tinyurl.com/mjaweu5
...“We are actively working towards initiating a clinical trial in the coming months to further investigate the potential synergistic effects of bavituximab and an approved [anti-CTLA-4] immunotherapy in patients with Melanoma."
10-28-13 IASLC/Sydney: “Immune Checkpoints in the Tumor Environment: Novel Targets & the Clinical Promise of Combined Immunotherapies” http://tinyurl.com/mjaweu5
…Symposium speakers: Scott J. Antonia/MD-PhD(H.Lee Moffitt CC), Dmitry I. Gabrilovich/MD-PhD(Wistar Inst), Rolf A. Brekken/PhD(UTSW), David E. Gerber/MD(UTSW)
BAVI MOA: 8-19-13 Data Supporting Bavituximab’s Immunotherapy MOA Published in “Cancer Immunology Research” (AACR) - http://tinyurl.com/mhjftka (PDF)
…“PS-Targeting Antibody Induces M1 Macrophage Polarization & Promotes Myeloid-Derived Suppressor Cell Differentiation” (Thorpe etal)
BAVI MOA: 8-13-13 PPHM/VP Dr. Jeff Hutchins’ Presentation on the Downstream Immunostimulatory Effects/Moa of PS-targeting antibodies (like Bavi) at CHI’s “Immunotherapies Congress”/Boston http://tinyurl.com/m6h2tvt
BAVI MOA: 10-12-12 NMB article on how Bavi "Induces Innate & Specific Anti-tumor Responses" http://tinyurl.com/cw9odb8
BAVI MOA: 5-1-12 Dr. Phil Thorpe's 46min talk at NYAS PS-Targeting Symposium http://tinyurl.com/9792gl5
. . .Symposium title: "Phosphatidylserine (PS) Asymmetry - Therapeutic Apps. in Cancer & Infectious Disease Symposium"
. . .Replays of 5 speakers: Alan Schroit, Chris Reutlingsperger, David Ucker, Ari Helenius, Philip Thorpe
BAVI MOA: 5-26-11 Dr.Thorpe's keynoter at Recombinant-Mabs/Barcelona http://tinyurl.com/3klpodc & http://tinyurl.com/3m33h33
= = = = = = = = = = = = = = = =
Roth/J.Pantginis 9-10-14 PPHM update…
Roth Capital /Joe Pantginis - init. 7-15-10 Buy/PT=$10, CURR: Buy/$5 http://www.roth.com
. . .Universe (click link bottom right): http://roth.bluematrix.com/docs/pdf/BLUE.pdf
9-10-14/PPHM: FY1Q15 RESULTS; BROADENING BAVITUXIMAB'S PROFILE
PPHM announced FY15/Q1 results, reporting EPS of ($.08), compared to our and the consensus estimate of ($.06). Total revenues for 1Q15 were $5.5mm vs. our est. of $5mm and consensus est. of $6mm. With IST data readouts in the upcoming months, we believe mgt. will be able to leverage that into expanding bavi's profile and further drive partnership discussions. The company ended Q1 (7-31-14) with $73.3mm in cash, which mgt. believes is sufficient to fund operations for ~12 mos. PPHM reiterated guidance for contract mfg. revenue for FY2015 of $19-$23mm.
Reiterate Buy and $5 target.
IMPACT
Alongside the SUNRISE Phase III study ongoing in over 130 sites, there will be addl. focus on data readouts from other programs in the upcoming months:
1) The Phase I/II study of bavituximab in combination with sorafenib in Hepatocellular (Liver) Carcinoma will have data presented at the Annual Meeting of the Society for the Immunotherapy of Cancer (SITC http://www.eventscribe.com/2014/sitc ) in early November
2) The Phase Ib of bavituximab in combination with carboplatin+pemetrexed in untreated stage IV NSCLC will have preliminary data presented at the Chicago Multidisciplinary Symposium in Thoracic Oncology (MSTO http://www.thoracicsymposium.org ) in late October.
Additionally, PPHM will present more data from the immuno-oncology program combining bavituximab with other immunotherapies, specifically, an anti-PD-1 checkpoint inhibitor, at SITC.
Data from the Liver Cancer study as well as from the immunooncology program should increase visibility, driving up potential partnering interest for bavituximab.
Recall that PPHM also indicated that it is looking to expand bavituximab's profile into other indications, particularly in Breast Cancer. At ASCO 2014 PPHM presented data from an IST of bavituximab+paclitaxel in HER2-neg. metastatic breast cancer, showing that 85% of patients achieved ORR, with 15% achieving CR by RECIST.
ACTION
We reiterate our Buy rating and $5 target. With Peregrine being a pivotal stage company, we view the risk/reward profile as favorable, and we believe visibility from the broadening bavituximab profile and partnering potential should drive the stock in 2014.
= = = = = = =KNOWN UPCOMING EVENTS: http://ir.peregrineinc.com/events.cfm
Sep26-30: “ESMO 2014 (Eur. Society for Medical Oncology)”, Madrid http://www.esmo.org/Conferences/ESMO-2014-Congress (Industry Partner: Peregrine Pharm.)
Oct6: CRI’s 22nd Annual Intl. Cancer Immunotherapy Symposium - "Cancer Immunotherapy: Out of the Gate”, NYC http://tinyurl.com/kvcbggw
Oct16 10:30amPT: Annual Shareholders Meeting (Irvine Marriott) http://ir.peregrineinc.com/events.cfm Proxy 8-28-14 (Def14A): http://tinyurl.com/kvnxgwg
Oct20-23/Avid(booth#1045): BioProcess Intl. (BPI) Conf. & Exhibition, Boston http://convention.bio.org/2014
Oct 30-Nov1: Multidisciplinary Symposium on Thoracic Oncology (MSTO), Chicago http://tinyurl.com/p2l43mt Sponsors: ASTRO, ASCO, IASLC, Univ/Chicago
...Per Joe Shan 9-9-14: “Data from the Ph.Ib IST Univ-Pitt. Bavituximab+CP/1stLine/Stage4/NSCLC”
…Nov1 10-10:30: Speaker Scott J. Antonia (PPHM SAB/KOL/Moffitt), “Immune …Modulation of Lung Cancer”
Nov6-9: “SITC 2014 – 29th Annual Meeting”, Natl-Harbor MD http://tinyurl.com/k4vprzd (per 9-9-14 C.Call/Jeff Hutchins & Qtly-Financials PR)
...Bavi+Yeryoy/Melanoma IST data (Ph1 IST/UTSW/Dr. Arthur Frankel)
...Bavi+Sorafenib/Liver Cancer IST data (5 sites: 3/UTSW, Parkland-Hosp, Dallas/VA, PI: Dr. Adam Yopp)
Nov22: ESMO Symposium on Immuno-Oncology 2014, Geneva http://tinyurl.com/ofljfgs
…11:30-11:50am, David Carbone, MD/PhD (Ohio-ST, PPHM KOL/SRB), session=”Advances in Cancer Immunotherapy; from Vaccines to Antibodies & Cell Therapies”, talk=”Immune Checkpoint Inhibitors in Lung Cancer”
Dec7-11/Avid(booth#319): IBC's Antibody Eng. & Therapeutics, HuntingtonBch http://www.ibclifesciences.com/AntibodyEng/overview.xml
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