Friday, December 12, 2014 10:53:17 AM
12-10-14 Qtly CC-Transcript, PR(Fins/Devs Q2FY15/qe10-31-14), updated Avid Revenues History Table By Quarter…
=> Total Revs May06-Oct14: $114.2mm/Avid + $24.1mm/Govt + $2.1mm/Lic. = $140.5mm
This large post has 3 sections:
I. 12-10-14 Q2/FY15 Qtly. Earnings Conf. Call TRANSCRIPT (q/e 10-31-14)
II. 12-10-14 PPHM Press Release: Q2/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/pgz8fb9 ], with numerous corrections made. )))
Link to webcast replay:
http://ir.peregrineinc.com/events.cfm => http://www.media-server.com/m/p/igth3acz
FULL TRANSCRIPT…
12-10-2014 Q2 FY’15 Earnings Conf. Call (q/e 10-31-14)
WELCOME & FWD-LOOKING STATEMENTS: Chris Keenan (IR) http://www.peregrineinc.com
Speakers: Steve King, Joe Shan, Jeff Hutchins, Paul Lytle; Q&A session.
CEO STEVE KING – OPENING COMMENTS:
Thanks to all of you who are participating in this afternoon’s call. The product development activities at Peregrine are dedicated to bringing our lead clinical program, bavituximab, to the market. Bavi represents the most clinically-advanced agent that targets the immuno-suppressive PS-signaling pathway. And while our initial focus is on NSCLC, bavi has broad potential across many different oncology indications where there remains unmet medical needs. Not only does bavi have broad potential across many tumor types, it also has the potential to be combined with many different types of treatments that are already the standard of care, as well as with compounds that are still in development. This includes chemotherapy, radiation, as well as other immuno-oncology agents. We are running a broad clinical program as well as a broad development program for bavituximab.
Leading the way are chemotherapy combinations, highlighted by our global Phase III trial named SUNRISE in 2nd-Line NSCLC. The SUNRISE trial is now open for enrollment at over a 150 centers worldwide, with an anticipated completion enrollment by the end of 2015. Recently, I had the opportunity to visit quite a number of clinical sites and meet with clinical teams & investigators. I have found these discussions to be quite encouraging and felt a general sense of enthusiasm for bavituximab and its position as a promising immuno-oncology agent. And while this is our lead indication, we have been studying bavi in combination with multiple different types of treatments and in multiple indications, including Breast, Liver, Front-Line NSCLC, Rectal adenocarcinoma, and Melanoma.
In addition, pre-clinical proof-of-concept studies support development in many other indications and with other combinations. Joe will give an update on the clinical programs following my introduction.
Perhaps the most exciting development in the oncology space over the past couple of years has been the emergence of new compounds that enhance immune system activity against cancer. Taken together, these compounds are referred to as immuno-oncology (I-O) compounds, and include investigational compounds such as bavituximab, as well as the proved compounds that target PD-1 & CTLA-4 pathways. Immuno-oncology agents have the potential not just to slow tumor growth, but in some patients to induce long-term remissions, even cures. While exciting, generally the majority of patients do not have these dramatic anti-tumor effects. This has led to numerous studies combining immune-oncology agents that stimulate the immune system at different points, referred to collectively as immune checkpoints, all with the goal to have more patients respond to PD-1 or CTLA-4 targeting compounds. The more data we see and the more we learn about the PS targets, the more excited we have become about the potential of bavituximab in combination with other IO agents, especially those targeting PD-1 & CTLA-4. What is apparent from a growing body of pre-clinical proof-of-concept data is that bavituximab is able to block tumor-mediated immuno suppression and to activate immune and anti-tumor immune responses, essentially taking the breaks off the immune system and hitting the accelerator for anti-tumor immune activity.
The most recent pre-clinical data that has been presented highlights the potential of bavituximab to increase the number of subjects responding to either PD-1 or CTLA targeted therapies, resulting in the majority of subjects actually responding. These results, along with initial translational data from a bavi Liver cancer IST have us very excited about the potential of bavituximab in combination with other IO compounds. And in fact the first study evaluating these combinations in the clinic is already underway, evaluating the combination of bavi plus the approved CTLA-4 targeted compound Yervoy in Melanoma patients. We anticipate several other studies to be planned and executed evaluating the combination of bavi with other IO agents in multiple oncology indications in the future. One final point that is worth emphasizing is that we believe Peregrine is in a unique position with an immune-oncology program already in Phase III, with what has been a positive safety profile and a target that is ideal for combining with other IO agents. Bavi goes after an upstream checkpoint, whereas PD-1 & CTLA-4 are downstream checkpoints. Combined, we believe bavituximab has the potential to be a significant player in the IO combination space. Jeff will update you on the exciting new developments in the IO combination studies during his portion of the presentation.
Another important part of our business model is our wholly owned mfg. subsidiary, Avid Bioservices. The 2nd qtr brought continued solid performance of $6.3mm in 3rd-party contract revenue for the qtr. This continued growth of Avid is a foundation for the announcement that we made earlier today regarding the expansion of our mfg. capacity. As you will hear from Paul Lytle, this is an exciting time for Avid and highlights the importance within our hybrid business model which is unique to biotechnology companies of our size.
Overall, we have made great progress across the company in areas aimed at furthering our mission of developing this innovative immunotherapy. As you will hear today, the coming months will bring presentations of data, the potential for scientific publications, continued execution of immune-oncology development programs, updates on the Avid expansion, and movements toward data from the pivotal SUNRISE trial.
JOE SHAN (VP/Clin.&Reg. Affairs) – CLINICAL TRIALS:
As you’ve just heard from Steve, our top clinical priority is to advance bavituximab so that it can be approved and made available to cancer patients as expeditiously as possible. This past quarter, we continued to make significant progress with our Phase III lung cancer trial, SUNRISE. With over 150 clinical centers across all 14 planned countries now opened for enrollment, our planned for site activation is almost complete and we remain on track to complete enrollment of approx. 600 patients by the end of CY 2015. As a reminder, this Phase III registration trial is designed with 2 planned interim analyses, both of which are event-driven.
Meanwhile, we continued to increase our clinical understanding of bavituximab with the recent data readouts. At the Society for ImmunoTherapy of Cancer [SITC] annual meeting last month [SITC’14/Nov7-8) http://tinyurl.com/pchzr6h ], we and our collaborators presented translational data from 6 patients in the Phase II IST evaluating bavituximab in combination with sorafenib in advanced Liver cancer. This is the first bavituximab clinical trial that was designed to prospectively assess immune changes within the tumor microenvironment and response to treatment. Immuno-histochemical analyses presented at the SITC Conference demonstrated that half of the patients we evaluated had an increase in tumor fighting CD8+ T cells following one 4-wk treatment cycle. Also, this increased CD8 expression generally correlated with time-to-disease-progression.
Translational results like these in treated patients strongly collaborate the immune activation processes we have seen in pre-clinical cancer models with PS blockade. And this is exactly the type of data which we can build upon to guide further bavituximab development programs and at the same time expand our growing network of world class experts and thought leaders in the field of cancer immunology. Clinical outcome data from this trial have been accepted in presentation at 2 upcoming meetings. The first will be a poster presentation at the ASCO GI Symposium in January, followed by an oral presentation at the Society of Surgical Oncology's Symposium in March. Both presentations will be made by Dr. Adam Yopp, who is an Assistant Professor of Surgery at UTSW-MC in Dallas and the principal investigator of the trial.
Next, in late October this year data from a Phase Ib IST evaluating bavituximab in combination with carboplatin & pemetrexed in patients with previously untreated stage IV NSCLC were presented at the Chicago Thoracic Oncology meeting [MSTO’14/Oct30 http://tinyurl.com/oz4w3zn ]. Patients treated with bavituximab in combination with carbo & pemetrexed achieved an overall response rate of 35%, a medium progression-free survival of 4.8mos, and a medium overall survival est. of 12.2mos. We believe these positive trends in response rates and overall survival, coupled with bavituximab’s favorable safety profile, support the further development of bavituximab as a part of frontline treatment regimens for NSCLC.
Last but not least, we remain committed to the development of bavituximab as a potential treatment option for Breast cancer. It’s very timely that we will be presenting exciting, emerging pre-clinical data at the San Antonio Breast Conference, which Jeff will touch upon shortly. We have completed 3 prior bavituximab trials in patients with advanced breast cancer including a Phase Ib IST conducted by Dr. Alison Stopeck in which she previously reported an 85% response rate in patients with HER2-negative metastatic breast cancer treated with a combination of bavituximab & paclitaxel. We are in active discussions with a number of key opinion leaders and potential collaborators and will like to advance these into the clinic as opportunities & resources permit.
JEFF HUTCHINS (VP/Preclinical Research):
As Steve mentioned, we have created an immune-oncology development plan to highlight the broad potential of bavituximab in multiple indications in concert with the most effective immune activating combinations. The pre-clinical piece of this plan is essential to learning & designing the next clinical steps to take. My team and I are looking at the PS targeting science & rationale for studies aimed at uncovering the most robust immune oncology combinations, particularly where resistance to anti-PD1 monotherapy is evident. What you have seen over the last qtr from our presentations at leading immunology-focused conferences is a growing body of evidence supporting the clinical investigation of bavituximab with downstream immune checkpoint inhibitors such as CTLA-4 and PD-1. The results we are seeing are positive and statistically significant in several models of cancer in multiple labs. What is most impressive is the consistency we are seeing over and over again in experiments that bavituximab drives immune activation inside the cancer with measurable effects on slowing progression towards a tumor-free status.
At the Annual CRI Conference [CRI’14/Immuno/Oct6 http://tinyurl.com/nkjlxep ], data showed that the bavi equivalent significantly enhances tumor growth inhibition of anti CTLA-4 antibody in Melanoma, as well as the efficacy of anti-PD-1 in B16 melanoma and EMT-6 breast cancer models, 2 models that are considered resistant to anti-PD-1 monotherapy. This exciting data concludes that targeting & blocking PFS with our bavi equivalent significantly improves the anti-tumor efficacy of an immune checkpoint blockade in robust models of Melanoma & Breast cancer in fully immune-confident animals.
With a goal of sharing these results with the IO community, we next presented data at the annual meeting of the Society for ImmunoTherapy of Cancer Conference [SITC’14/Nov7-8) http://tinyurl.com/pchzr6h ] showing that the combination of our bavi equivalent and an anti-PD-1 antibody yielded statistically significant increases in the CD8-to-CD3 T cell ratio in the tumor microenvironment compared to the anti-PD-1 antibody alone. This data is very similar to the data Joe mentioned in our translational Liver study [IST] showing increases in CDA cells in the tumor microenvironment.
So what does this mean? We actually are increasing the numbers of the most important immune soldiers on the war on cancer. What is also exciting was that the combination also decreases levels of Arg1, a molecule predominantly expressed by myeloid-derived suppressor cells, or MDSCs, as well as immuno-suppressive M2 macrophages in the tumor microenvironment. We know that these 2 key cell types contribute to immunosuppressive activity in animal models of Melanoma and, in the case of MDSCs, increased levels contributing to poor patient prognosis in the clinical setting.
So lastly, in a presentation to be made later this week at the San Antonio Breast Cancer Symposium [SanAntonio’14/Dec12 http://tinyurl.com/p5ng6vs ], a leading conference for breast cancer specialists, our researchers will discuss new immune-activating data focusing on the attractiveness of Breast cancer as an indication. The importance of these data, beyond the findings themselves, is that they support previous data generated in the same model system and presented at SITC indicating that the combination of our bavi equivalent and an anti-PD-1 antibody demonstrates statistically significant tumor growth inhibition in mice-bearing Breast tumors compared to anti-PD-1 alone, that T-cell infiltration in the tumor is significantly increased in tumors of mice treated with the combination of our bavi equivalent and anti-PD-1 compared to the single treatment alone, and finally, that the combination treatment resulted in significant reduction in MDSCs, whose presence plays a predominant role in suppressing the immune system associated with tumor progression and metastases in animal models. So taken together, this pre-clinical data reinforces our belief that bavituximab treatment is capable of converting non-responding anti-PD-1 therapy patients into clinical responders.
CFO Paul Lytle:
Turning to our financials, it’s important to note that we continue to closely manage our operations in line with our cash position while balancing our various sources of capital. One important source of capital is derived from our contract mfg. business, Avid Bioservices, which generated $6.3mm in revenue this qtr and we anticipate that contract mfg. revenue will be $19-23mm for the full FY (fye 4-30-15), in line with our previous guidance. Based on the success of our contract mfg. business, today we announced strategic plans to expand our mfg. capacity for Avid Bioservices. The new capacity will help meet both the increased demand of this growing business, as well as creating sufficient mfg. capacity for the potential commercial launch of bavituximab.
As a quick backdrop, the success of our client’s products and their immediate and anticipated mfg. needs have been extremely positive for growing this business. We are now at a time where we have anticipated manufacturing needs and exceed our current available capacity. So therefore, our choices are to either outsource our bavituximab mfg. needs to a 3rd-party manufacturer and incur addl. expenses, or to expand our internal mfg. capacity. Being mindful of our capital, we performed a thorough analysis to compare the cost of adding new internal mfg. capacity vs. the cost of outsourcing this capacity specifically focused on bavituximab only. Our cost benefit analysis clearly points to adding new internal capacities that will not only support the potential commercialization of bavituximab, but should also have tremendous upside from our contract mfg. business. Let me share a few highlights of this new commercial mfg. facility that is beginning to take shape. First, the new mfg. cleanroom & infrastructure will be placed in a vacant warehouse, where we recently leased ~40,000sf. 2nd, the leased space is located adjacent to our existing mfg. facility. This will help us achieve operational efficiencies and will help minimize overlapping costs that would be incurred with a distinct facility. 3rd, the new clean room design will utilize a more efficient and cost-effective disposable technology. This is a leading trend in biomanufacturing and does not require the massive utilities that are needed with traditional mfg. facilities. It is also important to note that the cost of building a mfg. cleanroom that utilizes disposable one-time use technology is a small fraction of traditional facilities. From a capacity standpoint, the commercial facility will accommodate multiple single-use bioreactors up to 2000L in size. On a volume basis, this facility can more than double our existing capacity and allow for continued growth at Avid while meeting our bavituximab mfg. needs. Again, we took great care in making this decision, as we followed a careful cost-benefit analysis of this initiative, and we look forward to bringing those new capacities online in mid-2015.
Turning to our statements of operations, we saw an expected increase in our net loss this quarter compared to the same period last year as we continue to execute on advancing the Phase III SUNRISE trial. As we invested in the Phase III trial, R&D spends increased to approximately ~$10mm this qtr, thereby increasing our net loss to ~$12mm. As a result, we saw a similar increase in our net cash burn from operations to $9.9mm this qtr, representing our net loss minus non-cash expenses. Our financial goals are centered on maintaining a solid cap position and investing these proceeds into our novel Immuno-Oncology program lead by bavituximab and our revenue generating mfg. business. We will closely manage our operations in line with our cap position, while balancing our sources of capital. We look forward to keeping your updated on our progress.
Q&A: [24:24 mark]
1. Roy Buchanan for Charles Duncan – Piper Jaffray [http://www.piperjaffray.com – 3-5-13 Initiates PPHM: http://tinyurl.com/bxhntk3 ]
RB: ”Hi, guys. This is Roy in for Charles… On the mfg. facility, I know you said it’s a fraction of the standard facility, but can you give us a rough est. of how much it will cost and when that will start showing up in the income statements?”
Paul Lytle: If you look at 10-Q, so far we have incurred about $2mm in construction & progress related to this facility. From a competitive standpoint, we’re not going to provide any addl. projections, but what I can say is that the cost of outsourcing our mfg. needs is fairly equivalent to the cost of building this facility with tremendous upside from the mfg. side of our business and also the upside of controlling our manufacturing destiny.
RB: ”Can you breakdown how much of the capacity is going to be used for bavi vs. contract mfg?”
Steve King: Upfront, bavituximab would require only a portion of the capacity, of course. We do have the ability to continue to expand the facility, so we do anticipate it will be adequate to handle bavituximab’s market introduction as well as other potential clients in a facility at the same time.
2. Joe Pantginis – Roth Capital Partners: [ http://www.roth.com & https://roth2.bluematrix.com/docs/pdf/BLUE.pdf ]
JP: ” Hey, guys… On the capacity expansion, what capacity do you have right now bavi-wise; how far can that get you? You obviously have enough capacity to supply your Phase III; what level of early commercialization if approved?”
Steve King: Obviously we’ve been manufacturing bavituximab in our existing facility; it’s been more adequate to provide clinical supplies for all of our ongoing studies and so those are already taking care of. I think the current facility will continue to support all clinical developments up until such time as the new facility is available. It’s anticipated that we would launch out of the new facility; that that would probably pretty close to fully support all the current indications that are underway. Now, of course, it’s going to be driven by clinical data and demand and what have you, but we do think we can launch out of this facility, meet early commercialization demands and with addl. capacity still for continuing to grow the Avid business. So, we do anticipate that there will be good opportunities as we go forward for new clients to come in or even existing clients to potentially move over and become part of fully utilizing that new facility. So, as Paul mentioned, we think it’s really a win-win. It keeps us on track for bavituximab commercialization as well as on track for growing the Avid business.
JP: ”If I could just switch gears to the Breast cancer indication, obviously you’re doing a lot of background work as you mentioned discussing with KOLs and discussing potential plans. So I guess using your words, ‘pending resources’ - based on all of this background work that you’re doing, how quickly could you go into more advance programs?”
Steve King: We have obviously already generated a significant amount of data in breast cancer in combination with both paclitaxel and docetaxel. Paclitaxel data was presented at ASCO, not this last year but the year before. So I think we have adequate information to drive into that sort of combination. Now, outside of chemotherapy combinations, combinations with other Immuno-Oncology agents in the Breast cancer space are also attractive, given the fact that we already have generated some positive data with bavi in that disease setting. So, we’re in a position where you know really, in a few different ways, we could move into the clinic. We just want to make sure we have the adequate resources to completely fund any study we start. So we’re looking into the trial design, the size of the trials; it’s always the possibility for things like Phase II, III studies and what have you, that kind of have 2 different components which makes them from a funding standpoint easier to just swallow upfront.
3. George Zavoico (MLV & Co.): http://www.mlvco.com
GZ: ” Hi… Question about Avid - you mentioned going forward your increasing capacity, does this mean you are expanding on your customer mix? Do you have the some new customers there? 2nd, re: switching over to the disposable technology, does that being another set of regulatory hurdles you need to cross to go from non-disposable to disposable? Lastly, just want to make sure I understand, you’re not filling the 40,000sq right now; you have room to expand in the future?”
Steve King: That’s correct. The bottom line is that we have seen expansion of our mix of customers, which is absolutely driving a lot of the need for considering new capacity, because we’ve being getting closer & closer to max capacity in the existing facility. Re: question #2, we’ve already been manufacturing in our existing facility in both stainless steel and single-use bioreactors, and in fact we have the ability to manufacture bavituximab in either one. So from a regulatory standpoint, it’s one of the goals of doing the facility expansion is actually to be able to keep almost identical systems to what we have been manufacturing bavituximab, to very much limit any regulatory risk. That’s been the primary goal of this new facility, going with disposable systems, they almost exactly mirror what we’re already producing bavi in, and what we make bavi for the Phase III in.
GZ: ”Over the I-O space, a general question both with regard to pre-clinical experiments you may have done, and also the carbo/pemetrexed trial - one of the key features of IO space obviously is that a significant, but small fraction of, patients have a durable response. Do you any evidence of that, do you see any evidence of that in any of your preclinical or clinical studies yet?”
Steve King: I can start off, and I’ll hand it over to Jeff, but that’s one of the things that is most exciting about the information we’re learning about program, because what we’re seeing is that if you look at in pre-clinical models, which mirrors pretty much the patient situation, that really it’s still in some of the systems a minority of the subjects in the study which actually end up having good anti-tumor effects. And what we’re seeing when you add bavituximab to whether it be PD-1 or CTLA-4, what we’re seeing is now that more of the subjects actually respond. So, it’s not necessarily making it work better and the subjects started working great again, but it’s really turning those non-responders into responders. I’ll hand over Jeff to expand on that.
Jeff Hutchins: We’ve been very careful as we present this data to not show averages just exactly to this point, at least in smaller squares that when we present data we show the individual animals and how they are responding. It’s exactly what Steve said, it’s the animals in this case that we’re bringing into the active treatment response that is really driving our excitement. When a patient or an animal responds to anti-PD-1 mono-therapy in a good way, it happens and they go on to a cure. So that’s kind of what we’re seeing - we’re after 60-80% of patients aren’t responding to the current checkpoint therapy in these models.
Steve King: If you look at the translational data from the Liver cancer study as presented in SITC, in the patients in which we did the analysis, we saw several patients that went from being low or negative PD-1, PDL-1 levels to being positive, and we know that PD-1 status positive is associated with good outcome on PD-1 therapy and negative associated with poor outcome. It’s exciting, the fact that we may be able to have our 1st evidence that we’re able to convert patients over from being negative to positive with regard to PD-1 status. So, early studies, limited number of patients, but we’re continuing to expand that out. It’s off to an exciting start, and everyone who has looked at the data has been pretty happy with it.
GZ: ”You talked about the SITC conference [SITC’14/Nov7-8) http://tinyurl.com/pchzr6h ], and you’re clearly going to a lot of conferences now. So the education as it were of the stakeholders, the caregivers of bavi being an immune checkpoint; it seems like you’re making much better progress now than you did a year ago when you first started out. Can you comment on how that’s going?”
Steve King: We’re much more active out in the immuno-oncology conferences where thought leaders were meeting. We’ve been getting more & more recognition of the role of the Phosphatidylserine (PS) immunosuppressive pathway and its role in controlling the immune system. When you really look at even the PS, PS receptors, there’s actually a lot of activity from other companies even in this space and we are by far the most advanced company or program looking at that particular target. So yes, it’s a lot of work; being at the conferences, making presentations, getting those interaction points. But secondly, it’s actively working with some of the KOLs in this area, and we are collaborating on several of these programs we’ve talked about with well-known, well-respected individuals in the I-O space, and that’s the other key, to get them to have the positive experience in their hands. And, that’s all underway. We’ve made great progress and we going to keep that until it’s a household name in the I-O space.
GZ: ”I wish you continued good luck in that. Thanks a lot.”
MR. KING’S CLOSING COMMENTS:
I’d like to thank all of you again for participating in today’s call. As was mentioned at several points today, our mission is to advance our novel immunotherapy while understanding its full potential in multiple indications. The framework for this mission has resulted in a late-stage clinical program, the SUNRISE trial. Now, with the work we are currently doing, including much of the activities that you have been seeing over the past several quarters from our immuno-oncology development program as well as proposals for clinical programs, we look forward to further strengthening this framework.
All of this pre-clinical & translational work is important in order to chart the next clinical course, as well as serving at the further validation of the immune-stimulatory mechanism of action that the founder of our technology, the late Dr. Phil Thorpe, was such a champion of. We feel strongly in our mission and believe in its value and that that value will be reflected in our share price as company milestones are reached. Thank you all for your support and have a great holiday season.
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12-10-14 PR: “Peregrine Pharmaceuticals Reports 2nd Quarter FY2015 Financial Results and Recent Developments”
• SUNRISE Phase III Lung Cancer Trial for Peregrine's Lead Immuno-Oncology Candidate Bavituximab Operational at Over 150 Sites Worldwide
• Data From Immuno-Oncology Development Program Shows Potential of Bavituximab to Significantly Enhance Checkpoint Inhibitors Anti-PD-1 and Anti-CTLA-4 in Multiple Preclinical Models
• Avid Bioservices Announces Expansion of Manufacturing Capacity to Support the Potential Commercial Launch of Bavituximab and Growth of Contract Manufacturing Business
TUSTIN, CA - 12/10/14: Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM, PPHMP), a biopharmaceutical company focused on advancing bavituximab, a new immuno-oncology antibody targeting the highly immunosuppressive phosphatidylserine (PS) signaling pathway, towards commercialization and providing integrated cGMP clinical and commercial bio-manufacturing services, today announced financial results for the second quarter of fiscal year (FY) 2015 ended October 31, 2014. The company also provided an update on its advancing clinical pipeline and reviewed other corporate developments.
"Our product development activities are dedicated to bringing bavituximab, the lead clinical compound targeting the inhibitory PS signaling pathway, to the market in order to address the unmet medical needs of cancer patients," said Steven W. King, president and chief executive officer of Peregrine. "Our lead effort towards this goal is the advancement of our bavituximab Phase III SUNRISE trial in non-small cell lung cancer, which is now open for enrollment at over 150 centers worldwide, with an anticipated completion of enrollment by the end of calendar year 2015. We have also made great strides in exploring new oncology opportunities including promising immuno-oncology combinations pairing bavituximab with PD-1 and CTLA-4 targeting agents resulting in significant therapeutic improvements in multiple preclinical cancer models. The combination of immuno-oncology agents has the potential to completely change the treatment paradigm for cancer patients and we feel bavituximab is in an excellent position to be a significant player in future immuno-oncology combination treatment options. On the contract manufacturing side of our business, we continued to see solid performance with $6.3 million in contract manufacturing revenues generated for the second quarter. We believe Avid has significant growth potential and in order to realize this, we are more than doubling our current biomanufacturing capacity."
The company's mission is to develop a brand new class of immunotherapies focused on the clinical advancement of our lead drug candidate bavituximab which targets the immunosuppressive PS signaling pathway. Bavituximab has the potential to be an effective part of treatment regimens in many different tumor types and has recently shown promise in combination with other immuno-oncology compounds. Over the past quarter, the company has made important progress in bringing this novel immunotherapy closer to the market led by the SUNRISE Phase III clinical trial.
The company has continued to open trial sites, now totaling over 150 worldwide, and to 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. The primary endpoint of the trial is overall survival. For additional information about the SUNRISE trial, please visit http://www.sunrisetrial.com or http://ClinicalTrials.gov using the Identifier NCT01999673. [ http://www.clinicaltrials.gov/ct2/show/NCT01999673 ]
The company's commitment to exploring the full clinical potential of bavituximab in combination with chemotherapies or other immuno-oncology agents is being executed through a series of Investigator-Sponsored Trials (IST) in multiple solid tumor indications. The following represents anticipated upcoming data from ongoing or completed clinical studies as well as the status of trials that can yield data in the future:
• Final data from a Phase I IST that evaluated bavituximab in combination with paclitaxel in patients with HER2-negative metastatic breast cancer has been submitted for publication and the company is currently evaluating opportunities to advance the clinical development of bavituximab in breast cancer.
• Data from a Phase I/II IST that evaluated bavituximab in combination with sorafenib in patients with advanced hepatocellular carcinoma (liver cancer) has been accepted for poster presentation at the 2015 Gastrointestinal Cancers Symposium to be held January 15-17, 2015 in San Francisco, California [ http://tinyurl.com/q5dyruw ] and for an oral presentation at the Society of Surgical Oncology's 68th Annual Cancer Symposium to be held March 25-28, 2015 in Houston, Texas [ http://events.jspargo.com/SSO15/public/enter.aspx ].
• Data from a Phase Ib IST that evaluated bavituximab in combination with carboplatin and pemetrexed in patients with previously untreated Stage IV NSCLC was presented at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology[MSTO’14/Oct30 http://tinyurl.com/oz4w3zn ]. In this single-arm trial, patients treated with bavituximab in combination with carboplatin and pemetrexed achieved an overall response rate (ORR) of 35%, a median progression free survival (PFS) of 4.8 months and a median overall survival (OS) of 12.2 months. Favorable trends in ORR and OS as well as tolerability continue to support the potential of bavituximab in NSCLC.
• A Phase I IST evaluating bavituximab in combination with capecitabine and radiation therapy in up to 18 patients with Stage II or III rectal adenocarcinoma is open for patient enrollment.
• A Phase Ib IST evaluating bavituximab in combination with Bristol-Myers Squibb's ipilimumab (Yervoy®) in up to 24 patients with advanced melanoma is open for patient enrollment.
As part of the company's mission to discover the full potential of its immunotherapy bavituximab in clinical disease applications, the company is advancing studies through its Immuno-Oncology Development Program. This program was designed to explore the potential of combining bavituximab with other immunotherapies, experimental immuno-oncology drugs including checkpoint inhibitors, as well as vaccines.
Data was recently presented at the Cancer Research Institutes' (CRI) "Cancer Immunotherapy: Out of the Gate" and the Society for Immunotherapy of Cancer's (SITC) 29th Annual Meeting and Associated Programs conferences [CRI’14/Immun/Oct6 http://tinyurl.com/nkjlxep ]. Data from the conferences show that tumor growth was significantly slowed in multiple aggressive tumor models of melanoma and breast cancer when combining ch1N11, the preclinical equivalent to bavituximab, with anti-CTLA-1 and anti-PD-1 agents compared to anti-CTLA-1 and anti-PD-1 agents alone. These data further support the combination of bavituximab and other immune checkpoint inhibitors.
Clinical translational data from six patients from the company's Immuno-Oncology Development Program in conjunction with the Phase II IST that evaluated bavituximab in combination with sorafenib in patients with advanced hepatocellular carcinoma was presented at the SITC 29th Annual Meeting [SITC’14/Nov7-8) http://tinyurl.com/pchzr6h ]. These data, to assess and measure changes in immune response pre- and post-treatment, show an increase in tumor fighting immune cells (particularly CD8 T cells) following one cycle of treatment with bavituximab, further confirming in patients what has been shown for PS-targeting antibodies in multiple preclinical cancer models.
Preclinical data from recently conducted studies will be presented in a poster titled: "Antibody-mediated Blockade of Phosphatidylserine Enhances the Anti-tumor Activity of Immune Checkpoint Inhibitor a-PD-1 by Affecting Myeloid Derived Suppressor Cells (MDSC) and Lymphocyte Populations in a Breast Tumor Microenvironment" at the 2014 San Antonio Breast Cancer Symposium on December 12, 2014 in San Antonio, Texas [SanAntonio’14/Dec12 http://tinyurl.com/p5ng6vs ].
The company is also exploring other applications for the PS-targeting platform outside of cancer therapy. These efforts include:
PS-TARGETING MOLECULAR IMAGING PROGRAM
The company is exploring the potential of its experimental PS-targeting molecular imaging candidate, 124I-PGN650, in patients with various solid tumor types. This is an open-label, single-center trial with a primary goal of estimating radiation dosimetry in critical and non-critical organs and secondary objectives of tumor imaging and safety.
ANTI-VIRAL PROGRAM
The company announced the publication of a manuscript in the Vaccines and Therapies for Biodefense Agents special edition of the peer-reviewed Journal of Immunology Research [ http://tinyurl.com/mv34bq5 ]. The paper discusses preclinical research demonstrating that the company's lead drug candidate bavituximab exhibits specific and strong binding to Ebola virions and Ebola virus-infected cells in vitro. These data warrant further collaborative investigation in Ebola and other infectious diseases including combinations with vaccines and active therapies that have shown promise.
AVID BIOSERVICES
Avid Bioservices, Inc. is the contract manufacturing subsidiary of Peregrine. Avid provides high quality clinical and commercial manufacturing services under cGMP for the biotechnology and biopharmaceutical industries. In a press release issued this morning [12-10-14 http://tinyurl.com/mmc3qgy ], the company announced the initiation of an expansion of manufacturing capacity for Avid Bioservices that will help meet the increased demands of this growing business while creating sufficient capacity for the commercial manufacturing of bavituximab. This facility will employ an innovative and flexible modular clean room design and the latest single-use technologies that provide expanded capacity to meet the growing needs of Avid's existing and future clients. The capacity expansion will take place within an existing 40,000 square foot warehouse located adjacent to the company's current campus. The new cGMP facility will accommodate multiple single-use bioreactors of up to 2,000 liters, downstream processing suites, and dedicated support utilities that will allow for the production of a variety of biological products.
"The success of our contract manufacturing business has led us to evaluate strategic options to expand our manufacturing capacity that will support the future growth of our manufacturing business as well as the anticipated commercial launch of bavituximab," said Paul Lytle, CFO of Peregrine. "This facility will allow us to achieve both of these stated goals in the most efficient and cost effective manner."
FINANCIAL RESULTS
Total revenues for the second quarter of FY 2015 were $6,300,000, compared to $7,354,000 for the same quarter of the prior fiscal year. The decrease was primarily attributed to a decrease 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 second quarter FY 2015 were $6,263,000, compared to $7,354,000 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 second quarter of FY 2015 were $18,437,000, compared to $15,168,000 in the second quarter of FY 2014. This increase was primarily attributable to the current quarter increase in research and development expenses associated with the SUNRISE Phase III trial combined with an incremental increase in selling, general and administrative expenses. For the second quarter FY 2015, research and development expenses were $10,003,000, compared to $6,957,000 for the second quarter of FY 2014. For the second quarter of FY 2015, selling, general and administrative expenses were $4,295,000, compared to $4,016,000 for the second quarter of FY 2014.
Peregrine's consolidated net loss attributable to common stockholders was $13,131,000, or $0.07 per share, for the second quarter of FY 2015, compared to a net loss attributable to common stockholders of $7,790,000, or $0.05 per share, for the same quarter of the prior year.
Peregrine reported $64,439,000 in cash and cash equivalents as of October 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. [ http://tinyurl.com/m6ldhg7 ]
CONFERENCE CALL
Peregrine will host a conference call and webcast this afternoon, December 10, 2014, at 4:30 PM EST (1:30 PM PST). To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Peregrine Pharmaceuticals conference call. To listen to the live webcast, or access the archived webcast, please visit: http://ir.peregrineinc.com/events.cfm .
ABOUT PEREGRINE PHARMACEUTICALS, INC.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a pipeline of novel drug candidates in clinical trials for the treatment and diagnosis of cancer. The company's lead immunotherapy candidate, bavituximab is in Phase III development for the treatment of second-line non-small lung cancer (the "SUNRISE trial") along with several investigator-sponsored trials evaluating other treatment combinations and additional oncology indications. The company is also advancing a molecular imaging agent, 124I-PGN650, in an exploratory clinical trial for the imaging of multiple solid tumor types. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com ), which provides development and biomanufacturing services for both Peregrine and third-party customers. Additional information about Peregrine can be found at http://www.peregrineinc.com .
Safe Harbor *snip*
Yervoy is a registered trademark of Bristol-Myers Squibb.
Contact: Christopher Keenan, Peregrine Pharmaceuticals, Inc., (800) 987-8256 - info@peregrineinc.com
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
Three Months Ended
October 31, Six Months Ended
October 31,
2014 2013 2014 2013
Unaudited Unaudited Unaudited Unaudited
REVENUES:
Contract manufacturing revenue $ 6,263,000 $ 7,354,000 $ 11,759,000 $ 11,935,000
License revenue 37,000 - 37,000 107,000
Total revenues 6,300,000 7,354,000 11,796,000 12,042,000
COSTS AND EXPENSES:
Cost of contract manufacturing 4,139,000 4,195,000 7,722,000 6,865,000
Research and development 10,003,000 6,957,000 20,204,000 12,261,000
Selling, general and administrative 4,295,000 4,016,000 9,178,000 8,350,000
Total costs and expenses 18,437,000 15,168,000 37,104,000 27,476,000
LOSS FROM OPERATIONS (12,137,000 ) (7,814,000 ) (25,308,000 ) (15,434,000 )
OTHER INCOME (EXPENSE):
Interest and other income 37,000 24,000 79,000 45,000
Interest and other expense - - - (1,000 )
NET LOSS $ (12,100,000 ) $ (7,790,000 ) $ (25,229,000 ) $ (15,390,000 )
COMPREHENSIVE LOSS $ (12,100,000 ) $ (7,790,000 ) $ (25,229,000 ) $ (15,390,000 )
Series E preferred stock accumulated dividends (1,031,000 ) - (1,802,000 ) -
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS $ (13,131,000 ) $ (7,790,000 ) $ (27,031,000 ) $ (15,390,000 )
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:
Basic and Diluted 179,962,275 156,948,226 179,540,265 153,170,928
BASIC AND DILUTED LOSS PER COMMON SHARE $ (0.07 ) $ (0.05 ) $ (0.15 ) $ (0.10 )
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
OCTOBER 31,
2014 APRIL 30,
2014
Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 64,439,000 $ 77,490,000
Trade and other receivables, net 3,361,000 1,332,000
Inventories 5,379,000 5,530,000
Prepaid expenses and other current assets, net 1,189,000 1,419,000
Total current assets 74,368,000 85,771,000
Property and equipment, net 5,398,000 2,447,000
Other assets 1,671,000 2,327,000
TOTAL ASSETS $ 81,437,000 $ 90,545,000
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 3,840,000 $ 2,434,000
Accrued clinical trial and related fees 2,537,000 4,433,000
Accrued payroll and related costs 3,472,000 3,837,000
Deferred revenue, current portion 3,612,000 5,241,000
Customer deposits 7,549,000 5,760,000
Other current liabilities 572,000 502,000
Total current liabilities 21,582,000 22,207,000
Deferred revenue, less current portion - 292,000
Other long-term liabilities 1,078,000 347,000
Commitments and contingencies
STOCKHOLDERS' EQUITY:
Preferred stock-$0.001 par value; authorized 5,000,000 shares; issued and outstanding -- 1,177,858 and 775,000, respectively 1,000 1,000
Common stock-$0.001 par value; authorized 325,000,000 shares; outstanding -- 182,000,583 and 178,871,164, respectively 182,000 179,000
Additional paid-in capital 487,089,000 470,785,000
Accumulated deficit (428,495,000 ) (403,266,000 )
Total stockholders' equity 58,777,000 67,699,000
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 81,437,000 $ 90,545,000
- - - - - - - - -
[ From 10-Q header: “As of Dec. 5, 2014, there were 182,081,234 shares of issuer’s common stock.”
- - - - - - - - - - - - - - - - -
Latest 10K 4-30-14 iss. 7-14-14: http://tinyurl.com/mhva3k3 PR: http://tinyurl.com/o2e4a4g (Cash 4-30-14=$77.5mm)
Latest 10Q 10-31-14 iss. 12-10-14 http://tinyurl.com/m6ldhg7 PR: http://tinyurl.com/kmdgq8t (Cash 10-31-14=$64.4mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
.
.
= = = = = = = = = = = = = = = = = = = = = = = = = = = =
Updated PPHM REVS-BY-QTR TABLE, now thru FY15/Q2 (qe 10-31-14), per the 10-31-14 10-Q ( http://tinyurl.com/m6ldhg7 ) issued 12-10-14. Deferred-Revs at 10-31-14, going fwd into FY’15/Q3 (q/e 1-31-15), total $3.6mm, down from the $4.7mm of Deferred-Revs at 7-31-14 that drove into FY’15/Q2.
Total Revs since May’06: ($114.2mm/Avid + $24.1mm/Govt + $2.1mm/Lic.) = $140.5mm
==> Recall, Avid Rev$ from Gov’t DTRA Contract work (6/30/08 – 4/15/11, totaling $24.15mm), went into GOVT-REVS, not AVID-REVS, in the Financials.
Avid’s website: http://www.avidbio.com
*The 10-Q’s define OPER.BURN as, ”Net cash used in operating activities before chgs. in operating assets & liabilities”.
The 7-21-2001 10Q explains OP.BURN very nicely:
“RESULTS OF OPERATIONS. Before we discuss the Company's total expenses (cash & non-cash expenses), we would like to discuss the Company's operational burn rate (cash expenses used in operations, net of interest and other income) for q/e July 31, 2001 compared to the same period in the prior year. The operational burn rate is calculated by taking the net income (loss) from operations and subtracting all non-cash items, such as the recognition of deferred license revenue, depreciation and amortization and stock-based compensation expense.”
.
- - - - - - - - PPHM’s Fiscal Qtr’s (FY runs May – April):
FY’10-Q3 = q/e 1-31-10 – rep. 3-11-10 Thu (B4 mkt)
FY’10-Q4 = q/e 4-30-10 – rep. 7-14-10 Wed (after mkt)
FY’11-Q1 = q/e 7-31-10 – rep. 9-9-10 Thu (after mkt)
FY’11-Q2 = q/e 10-31-10 – rep. 12-9-10 Thu (after mkt)
FY’11-Q3 = q/e 1-31-10 – rep. 3-11-11 Fri (after mkt)
FY’11-Q4 = q/e 4-30-11 – rep. 7-14-11 Thu (after mkt)
FY’12-Q1 = q/e 7-31-11 – rep. 9-9-11 Fri (B4 mkt)
FY’12-Q2 = q/e 10-31-11 – rep. 12-12-11 Mon (after mkt)
FY’12-Q3 = q/e 1-31-12 – rep. 3-9-12 Fri (after mkt)
FY’12-Q4 = q/e 4-30-12 – rep. 7-16-12 Mon (after mkt)
FY’13-Q1 = q/e 7-31-12 – rep. 9-10-12 Mon (B4 mkt)
FY’13-Q2 = q/e 10-31-12 – rep. 12-10-12 Mon (after mkt)
FY’13-Q3 = q/e 1-31-13 – rep. 3-12-13 Tue (after mkt)
FY’13-Q4 = q/e 4-30-13 – rep. 7-11-13 Thu (after mkt)
FY’14-Q1 = q/e 7-31-13 – rep. 9-9-13 Mon (after mkt)
FY’14-Q2 = q/e 10-31-13 – rep. 12-10-13 Tue (after mkt)
FY’14-Q3 = q/e 1-31-14 – rep. 3-7-14 Fri (B4 mkt)
FY’14-Q4 = q/e 4-30-14 – rep. 7-14-14 Mon (after mkt)
FY’15-Q1 = q/e 7-31-14 – rep. 9-9-14 Tue (after mkt)
FY’15-Q2 = q/e 10-31-14 – rep. 12-10-14 Wed (after mkt)
= = = = = = = = = = = =
“Going Concern” statement ELIMINATED from 4-30-13 10-K issued 7-11-2013…
2012: 4-30-12 10-K iss. 7-16-12 http://tinyurl.com/79o57b2
Pg.68: “As more fully described in Note 2, the Company’s recurring losses from operations and recurring negative cash flows from operating activities raise substantial doubt about its ability to continue as a going concern.”
2013 & 2014 10-K's: http://tinyurl.com/p58jcbw & http://tinyurl.com/mhva3k3 ==> ((((NO GOING CONCERN STATEMENT INCLUDED.))))
CASH a/o 4-30-13: $35.2mm
CASH a/o 6-30-13: $42.6mm
CASH a/o 7-31-13: $41.6mm
CASH a/o 10-31-13: $44.4mm
CASH a/o 1-31-14: $63.2mm
CASH a/o 2-15-14: $79.7mm
CASH a/o 4-30-14: $77.5mm
CASH a/o 6-30-14: $78.3mm
CASH a/o 7-31-14: $73.3mm
CASH a/o 10-31-14: $64.4mm
= = = = = = = = = = 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 12-10-2014:
http://www.peregrineinc.com/images/stories/pdfs/dec_2014_corp_fact_sheet.pdf
= = = = = = = = = = = = = = =
10-16-14 Peregrine ASM: Slides(42), Audio-Replay-Link, Attendee-Reports http://tinyurl.com/oyc3e5v
9-9-14 Qtly. Conf. Call (King/Hutchins/Shan/Lytle) Transcript http://tinyurl.com/ktrfswj
...CEO S.King: “In addition to our clinical trials, many of which have also have translational data points built in to tie together pre-clin. data with the clinic, we have also continued to build momentum in our pre-clin. collaborations which now number in the dozens. We are evaluating new combinations & dosing strategies combining bavituximab with chemotherapy, radiation, and immune-oncology approaches, including those targeting CTLA-4, PD-1, as well as other downstream immune checkpoints."
7-14-14 Qtly. Conf. Call (King/Shan/Hutchins/Worsley/Lytle) Transcript http://tinyurl.com/o2e4a4g
...CEO S.King: “Partnering remains a priority with the goal being to use partnerships to continue expanding the bavituximab program, while we continue to execute the SUNRISE Phase III trial.”
3-10-14: CEO Steve King’s 22min. talk at ROTH Conf. (DanaPT CA) - SLIDES http://tinyurl.com/n65myfk
3-7-14 Qtly. Conf. Call (King/Shan/Garnick/Lytle) Transcript http://tinyurl.com/kh9cnrg
...CEO S.King: “I don't want to overuse the word ‘excitement’, but these are truly exciting times that have positioned us for success on all fronts.”
12-10-13 Qtly. Conf. Call (King/Shan/Garnick/Hutchins/Worsley/Lytle) Transcript http://tinyurl.com/mw776mk
...CEO S.King: “We believe that Peregrine is uniquely positioned among the companies developing immunotherapies… and that because of our current valuation, we represent a unique investment opportunity.
• All of Dr. Robert Garnick's public comments (thru 3-7-2014) while at Peregrine: http://tinyurl.com/obvwyuh Steve King said 6-29-11, "Rob is the ringmaster."
• 6-29-11 Minyanville article, "Peregrine Pharma's Secret Weapon [Robert Garnick]" http://tinyurl.com/9jtnan o
• Examples of Dr. Garnick's work at Genentech on Avastin (bevacizumab) approvals: http://tinyurl.com/yg7vtqa
PS-TARGETING SCIENCE: "Evolution has favored pathogenesis that resembles apoptosis."
Dr. Judah Folkman: ”This [Thorpe’s VTA research] is very promising and very elegant work... The whole goal is really 2-part, reducing the harsh side effects of cancer treatment, and reducing the chance that some cancer cells will evade treatment. That would be a big step in the next decade, and anti-vascular therapy will play a major role." (’97 & ’02 http://tinyurl.com/k5qe96g & http://tinyurl.com/n6vh9hp )
Peregrine's Bavituximab & Cotara Technologies: http://www.peregrineinc.com/technology/overview.html
Peregrine's Clinical Trials website: http://PeregrineTrials.com
- - - - - - - -
Bavituximab MOA & Clinical Data: http://www.peregrineinc.com/pipeline/bavituximab-oncology.html
...Bavi Publications: http://www.peregrineinc.com/publications/publications.html
...Bavi Posters & Presentations: http://www.peregrineinc.com/publications/posters-and-presentations.html
Bavi MOA: Video (3:34) added ~3-2014 http://vimeo.com/87116642 "Bavituximab: A Novel Immunotherapy Candidate Targeting an Upstream Immune Checkpoint to Fight Cancer"
Bavi MOA: Video (1:33) on Bavi’s Immunotherapeutic MOA added to Youtube on 3-27-14 https://www.youtube.com/watch?v=Esewl35JD8s
BAVI MOA 11-2014 SITC’14: 3 posters on preclin. Bavi+aCTLA4/aPD1 combo data (Hutchins Freimark Brekken Huang etal) http://tinyurl.com/pchzr6h
BAVI MOA 8-28-14: Italy’s Dr. Federico Cappuzzo, Bavi/NSCLC profile article (DovePress OpenAccess, 7pgs) - http://tinyurl.com/n3oa7bc
BAVI MOA 8-11-14: PPHM/VP Dr. Jeff Hutchins’ presentation at ImVacS "Immunotherapies & Vaccine Summit", Boston - PR: http://tinyurl.com/lpjy3u7 ; PDF(31 Slides): http://tinyurl.com/oueldme
...MLV’s Dr. George Zavoico’s 8-27-14 report on Dr. Jeff Hutchins’ 8-11-14 ImVacS/Boston Bavi MOA presentation: http://tinyurl.com/l3tw63c
BAVI MOA 5-28-14: Dr. Rolf Brekken’s 47min CRI “Cancer Immunotherapy” webinar about Bavituximab as an Upstream/Global Immune Checkpoint Inhibitor – REPLAY: http://tinyurl.com/lxgftyx
. . .CRI=Cancer Research Institute (NYC – Supported by BMS): http://www.cancerresearch.org - Facebook: http://tinyurl.com/pbmhb2z , https://twitter.com/CancerResearch
. . .CRI launches “Answer to Cancer” (cancer immunotherapy) website http://www.theanswertocancer.org
. . .8-12-14: CRI adds Youtube links to the 5-28-14 CRI Immunotherapy webinar, incl. Dr. Brekken's talk "about Bavi and how it works against lung, liver, and other kinds of cancers" http://tinyurl.com/ps5h6h8
BAVI MOA 3-25-14: Dr. Rolf Brekken’s 40min talk at NYAS Lung Cancer Symposium http://tinyurl.com/lq9stnk (45 Slides)
. . .Dr.Brekken’s talk: “Antibody-mediated Inhibition of PS - A Novel Strategy for Immune Checkpoint Blockade” (the 5 speakers: Jessica Donington, Roy Herbst, Balazs Halmos, Suresh Ramalingam, Rolf Brekken)
12-10-13: With recent scientific insights highlighting bavi’s immunostimulatory moa, these additions to PPHM’s SAB: Dimitry Gabrilovich, Scott Antonia, David Carbone**, Hakan Mellstedt http://tinyurl.com/mw776mk
......**A/o 9-2014, Dr. David Carbone (PPHM SAB/KOL) is President-Elect of IASLC https://www.iaslc.org/about-us/board
BAVI MOA: 12-2013 Bavi’s Immunotherapeutic MOA overviewed by UTSW’s Brekken/Huang in Pan European Networks Jrnl. http://tinyurl.com/lnb46pq
BAVI MOA 11-9-13: Annual SITC (WashDC) – 2 posters about Bavi’s Immunostimulatory MOA http://tinyurl.com/mjaweu5
...“We are actively working towards initiating a clinical trial in the coming months to further investigate the potential synergistic effects of bavituximab and an approved [anti-CTLA-4] immunotherapy in patients with Melanoma."
10-28-13 IASLC/Sydney: “Immune Checkpoints in the Tumor Environment: Novel Targets & the Clinical Promise of Combined Immunotherapies” http://tinyurl.com/mjaweu5
…Symposium speakers: Scott J. Antonia/MD-PhD(H.Lee Moffitt CC), Dmitry I. Gabrilovich/MD-PhD(Wistar Inst), Rolf A. Brekken/PhD(UTSW), David E. Gerber/MD(UTSW)
BAVI MOA: 8-19-13 Data Supporting Bavituximab’s Immunotherapy MOA Published in “Cancer Immunology Research” (AACR) - http://tinyurl.com/mhjftka (PDF)
…“PS-Targeting Antibody Induces M1 Macrophage Polarization & Promotes Myeloid-Derived Suppressor Cell Differentiation” (Thorpe etal)
BAVI MOA: 8-13-13 PPHM/VP Dr. Jeff Hutchins’ Presentation on the Downstream Immunostimulatory Effects/Moa of PS-targeting antibodies (like Bavi) at CHI’s “Immunotherapies Congress”/Boston http://tinyurl.com/m6h2tvt
BAVI MOA: 10-12-12 NMB article on how Bavi "Induces Innate & Specific Anti-tumor Responses" http://tinyurl.com/cw9odb8
BAVI MOA: 5-1-12 Dr. Phil Thorpe's 46min talk at NYAS PS-Targeting Symposium http://tinyurl.com/9792gl5
. . .Symposium title: "Phosphatidylserine (PS) Asymmetry - Therapeutic Apps. in Cancer & Infectious Disease Symposium"
. . .Replays of 5 speakers: Alan Schroit, Chris Reutlingsperger, David Ucker, Ari Helenius, Philip Thorpe
BAVI MOA: 5-26-11 Dr.Thorpe's keynoter at Recombinant-Mabs/Barcelona http://tinyurl.com/3klpodc & http://tinyurl.com/3m33h33
= = = = = = = = = = = = = = = = Roth/J.Pantginis 12-11-14 PPHM update…
Roth Capital /Joe Pantginis - init. 7-15-10 Buy/PT=$10, CURR: Buy/$5 http://www.roth.com
. . .Universe (click link bottom right): http://roth.bluematrix.com/docs/pdf/BLUE.pdf
12-11-14/PPHM:
“F2Q15 Results; Brace Yourselves for Lots of Data Coming in 2015”
• PPHM announced F2Q15 results posting EPS of ($.07) compared to our est. of ($.08). Revenues for the qtr were $6.3mm compared to our est. of $5.6mm, and the company ended the qtr with $64.4mm in cash.
• Enrollment in the Phase III SUNRISE study is expected to be complete by YE15.
• We look forward to what is shaping up to be a data-driven 2015 with catalysts from multiple studies in hepatocellular carcinoma, NSCLC, Melanoma, and Rectal adenocarcinoma.
• Reiterate Buy, $5 target.
IMPACT:
We are encouraged by the continued progress in SUNRISE enrollment as well as by management efforts to expand bavituximab's profile. As SUNRISE continues to enroll patients at over 150 global centers, we look forward to what is shaping up to be a data-driven 2015 with catalysts from multiple ISTs in hepatocellular carcinoma, NSCLC, breast cancer, melanoma and rectal adenocarcinoma. We believe that data from the Phase Ib of bavituximab with ipilimumab in Melanoma will garner interest and increase visibility. This study, set to enroll up to 24 patients, should provide further support for combination of bavituximab with checkpoint inhibitors. We look forward to updated data from the Phase I/II IST study of bavituximab with sorafenib in Liver cancer at GI ASCO (Jan’15) and SSO (Mar’15). Recall that data from this study at SITC showed that following treatment, there was an increase in CD8+ infiltrating cells into the tumor mass as well as induction of PD1+, giving additional support for combination study with anti-PD-1 inhibitors. PPHM also expects to have addl. data from a Phase Ib IST study of bavituximab with carboplatin & pemetrexed in untreated stage IV NSCLC. A Phase I IST of bavituximab with capecitabine & radiation in Rectal adenocarcinoma is also expected to have data, expanding bavituximab's potential treatment profile. We look forward to see how PPHM follows up with the clinical development program in Breast cancer, with final data from the Phase I IST study in HER2-negative metastatic Breast cancer submitted for publication.
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 2015.
=> Total Revs May06-Oct14: $114.2mm/Avid + $24.1mm/Govt + $2.1mm/Lic. = $140.5mm
This large post has 3 sections:
I. 12-10-14 Q2/FY15 Qtly. Earnings Conf. Call TRANSCRIPT (q/e 10-31-14)
II. 12-10-14 PPHM Press Release: Q2/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/pgz8fb9 ], with numerous corrections made. )))
Link to webcast replay:
http://ir.peregrineinc.com/events.cfm => http://www.media-server.com/m/p/igth3acz
FULL TRANSCRIPT…
12-10-2014 Q2 FY’15 Earnings Conf. Call (q/e 10-31-14)
WELCOME & FWD-LOOKING STATEMENTS: Chris Keenan (IR) http://www.peregrineinc.com
Speakers: Steve King, Joe Shan, Jeff Hutchins, Paul Lytle; Q&A session.
CEO STEVE KING – OPENING COMMENTS:
Thanks to all of you who are participating in this afternoon’s call. The product development activities at Peregrine are dedicated to bringing our lead clinical program, bavituximab, to the market. Bavi represents the most clinically-advanced agent that targets the immuno-suppressive PS-signaling pathway. And while our initial focus is on NSCLC, bavi has broad potential across many different oncology indications where there remains unmet medical needs. Not only does bavi have broad potential across many tumor types, it also has the potential to be combined with many different types of treatments that are already the standard of care, as well as with compounds that are still in development. This includes chemotherapy, radiation, as well as other immuno-oncology agents. We are running a broad clinical program as well as a broad development program for bavituximab.
Leading the way are chemotherapy combinations, highlighted by our global Phase III trial named SUNRISE in 2nd-Line NSCLC. The SUNRISE trial is now open for enrollment at over a 150 centers worldwide, with an anticipated completion enrollment by the end of 2015. Recently, I had the opportunity to visit quite a number of clinical sites and meet with clinical teams & investigators. I have found these discussions to be quite encouraging and felt a general sense of enthusiasm for bavituximab and its position as a promising immuno-oncology agent. And while this is our lead indication, we have been studying bavi in combination with multiple different types of treatments and in multiple indications, including Breast, Liver, Front-Line NSCLC, Rectal adenocarcinoma, and Melanoma.
In addition, pre-clinical proof-of-concept studies support development in many other indications and with other combinations. Joe will give an update on the clinical programs following my introduction.
Perhaps the most exciting development in the oncology space over the past couple of years has been the emergence of new compounds that enhance immune system activity against cancer. Taken together, these compounds are referred to as immuno-oncology (I-O) compounds, and include investigational compounds such as bavituximab, as well as the proved compounds that target PD-1 & CTLA-4 pathways. Immuno-oncology agents have the potential not just to slow tumor growth, but in some patients to induce long-term remissions, even cures. While exciting, generally the majority of patients do not have these dramatic anti-tumor effects. This has led to numerous studies combining immune-oncology agents that stimulate the immune system at different points, referred to collectively as immune checkpoints, all with the goal to have more patients respond to PD-1 or CTLA-4 targeting compounds. The more data we see and the more we learn about the PS targets, the more excited we have become about the potential of bavituximab in combination with other IO agents, especially those targeting PD-1 & CTLA-4. What is apparent from a growing body of pre-clinical proof-of-concept data is that bavituximab is able to block tumor-mediated immuno suppression and to activate immune and anti-tumor immune responses, essentially taking the breaks off the immune system and hitting the accelerator for anti-tumor immune activity.
The most recent pre-clinical data that has been presented highlights the potential of bavituximab to increase the number of subjects responding to either PD-1 or CTLA targeted therapies, resulting in the majority of subjects actually responding. These results, along with initial translational data from a bavi Liver cancer IST have us very excited about the potential of bavituximab in combination with other IO compounds. And in fact the first study evaluating these combinations in the clinic is already underway, evaluating the combination of bavi plus the approved CTLA-4 targeted compound Yervoy in Melanoma patients. We anticipate several other studies to be planned and executed evaluating the combination of bavi with other IO agents in multiple oncology indications in the future. One final point that is worth emphasizing is that we believe Peregrine is in a unique position with an immune-oncology program already in Phase III, with what has been a positive safety profile and a target that is ideal for combining with other IO agents. Bavi goes after an upstream checkpoint, whereas PD-1 & CTLA-4 are downstream checkpoints. Combined, we believe bavituximab has the potential to be a significant player in the IO combination space. Jeff will update you on the exciting new developments in the IO combination studies during his portion of the presentation.
Another important part of our business model is our wholly owned mfg. subsidiary, Avid Bioservices. The 2nd qtr brought continued solid performance of $6.3mm in 3rd-party contract revenue for the qtr. This continued growth of Avid is a foundation for the announcement that we made earlier today regarding the expansion of our mfg. capacity. As you will hear from Paul Lytle, this is an exciting time for Avid and highlights the importance within our hybrid business model which is unique to biotechnology companies of our size.
Overall, we have made great progress across the company in areas aimed at furthering our mission of developing this innovative immunotherapy. As you will hear today, the coming months will bring presentations of data, the potential for scientific publications, continued execution of immune-oncology development programs, updates on the Avid expansion, and movements toward data from the pivotal SUNRISE trial.
JOE SHAN (VP/Clin.&Reg. Affairs) – CLINICAL TRIALS:
As you’ve just heard from Steve, our top clinical priority is to advance bavituximab so that it can be approved and made available to cancer patients as expeditiously as possible. This past quarter, we continued to make significant progress with our Phase III lung cancer trial, SUNRISE. With over 150 clinical centers across all 14 planned countries now opened for enrollment, our planned for site activation is almost complete and we remain on track to complete enrollment of approx. 600 patients by the end of CY 2015. As a reminder, this Phase III registration trial is designed with 2 planned interim analyses, both of which are event-driven.
Meanwhile, we continued to increase our clinical understanding of bavituximab with the recent data readouts. At the Society for ImmunoTherapy of Cancer [SITC] annual meeting last month [SITC’14/Nov7-8) http://tinyurl.com/pchzr6h ], we and our collaborators presented translational data from 6 patients in the Phase II IST evaluating bavituximab in combination with sorafenib in advanced Liver cancer. This is the first bavituximab clinical trial that was designed to prospectively assess immune changes within the tumor microenvironment and response to treatment. Immuno-histochemical analyses presented at the SITC Conference demonstrated that half of the patients we evaluated had an increase in tumor fighting CD8+ T cells following one 4-wk treatment cycle. Also, this increased CD8 expression generally correlated with time-to-disease-progression.
Translational results like these in treated patients strongly collaborate the immune activation processes we have seen in pre-clinical cancer models with PS blockade. And this is exactly the type of data which we can build upon to guide further bavituximab development programs and at the same time expand our growing network of world class experts and thought leaders in the field of cancer immunology. Clinical outcome data from this trial have been accepted in presentation at 2 upcoming meetings. The first will be a poster presentation at the ASCO GI Symposium in January, followed by an oral presentation at the Society of Surgical Oncology's Symposium in March. Both presentations will be made by Dr. Adam Yopp, who is an Assistant Professor of Surgery at UTSW-MC in Dallas and the principal investigator of the trial.
Next, in late October this year data from a Phase Ib IST evaluating bavituximab in combination with carboplatin & pemetrexed in patients with previously untreated stage IV NSCLC were presented at the Chicago Thoracic Oncology meeting [MSTO’14/Oct30 http://tinyurl.com/oz4w3zn ]. Patients treated with bavituximab in combination with carbo & pemetrexed achieved an overall response rate of 35%, a medium progression-free survival of 4.8mos, and a medium overall survival est. of 12.2mos. We believe these positive trends in response rates and overall survival, coupled with bavituximab’s favorable safety profile, support the further development of bavituximab as a part of frontline treatment regimens for NSCLC.
Last but not least, we remain committed to the development of bavituximab as a potential treatment option for Breast cancer. It’s very timely that we will be presenting exciting, emerging pre-clinical data at the San Antonio Breast Conference, which Jeff will touch upon shortly. We have completed 3 prior bavituximab trials in patients with advanced breast cancer including a Phase Ib IST conducted by Dr. Alison Stopeck in which she previously reported an 85% response rate in patients with HER2-negative metastatic breast cancer treated with a combination of bavituximab & paclitaxel. We are in active discussions with a number of key opinion leaders and potential collaborators and will like to advance these into the clinic as opportunities & resources permit.
JEFF HUTCHINS (VP/Preclinical Research):
As Steve mentioned, we have created an immune-oncology development plan to highlight the broad potential of bavituximab in multiple indications in concert with the most effective immune activating combinations. The pre-clinical piece of this plan is essential to learning & designing the next clinical steps to take. My team and I are looking at the PS targeting science & rationale for studies aimed at uncovering the most robust immune oncology combinations, particularly where resistance to anti-PD1 monotherapy is evident. What you have seen over the last qtr from our presentations at leading immunology-focused conferences is a growing body of evidence supporting the clinical investigation of bavituximab with downstream immune checkpoint inhibitors such as CTLA-4 and PD-1. The results we are seeing are positive and statistically significant in several models of cancer in multiple labs. What is most impressive is the consistency we are seeing over and over again in experiments that bavituximab drives immune activation inside the cancer with measurable effects on slowing progression towards a tumor-free status.
At the Annual CRI Conference [CRI’14/Immuno/Oct6 http://tinyurl.com/nkjlxep ], data showed that the bavi equivalent significantly enhances tumor growth inhibition of anti CTLA-4 antibody in Melanoma, as well as the efficacy of anti-PD-1 in B16 melanoma and EMT-6 breast cancer models, 2 models that are considered resistant to anti-PD-1 monotherapy. This exciting data concludes that targeting & blocking PFS with our bavi equivalent significantly improves the anti-tumor efficacy of an immune checkpoint blockade in robust models of Melanoma & Breast cancer in fully immune-confident animals.
With a goal of sharing these results with the IO community, we next presented data at the annual meeting of the Society for ImmunoTherapy of Cancer Conference [SITC’14/Nov7-8) http://tinyurl.com/pchzr6h ] showing that the combination of our bavi equivalent and an anti-PD-1 antibody yielded statistically significant increases in the CD8-to-CD3 T cell ratio in the tumor microenvironment compared to the anti-PD-1 antibody alone. This data is very similar to the data Joe mentioned in our translational Liver study [IST] showing increases in CDA cells in the tumor microenvironment.
So what does this mean? We actually are increasing the numbers of the most important immune soldiers on the war on cancer. What is also exciting was that the combination also decreases levels of Arg1, a molecule predominantly expressed by myeloid-derived suppressor cells, or MDSCs, as well as immuno-suppressive M2 macrophages in the tumor microenvironment. We know that these 2 key cell types contribute to immunosuppressive activity in animal models of Melanoma and, in the case of MDSCs, increased levels contributing to poor patient prognosis in the clinical setting.
So lastly, in a presentation to be made later this week at the San Antonio Breast Cancer Symposium [SanAntonio’14/Dec12 http://tinyurl.com/p5ng6vs ], a leading conference for breast cancer specialists, our researchers will discuss new immune-activating data focusing on the attractiveness of Breast cancer as an indication. The importance of these data, beyond the findings themselves, is that they support previous data generated in the same model system and presented at SITC indicating that the combination of our bavi equivalent and an anti-PD-1 antibody demonstrates statistically significant tumor growth inhibition in mice-bearing Breast tumors compared to anti-PD-1 alone, that T-cell infiltration in the tumor is significantly increased in tumors of mice treated with the combination of our bavi equivalent and anti-PD-1 compared to the single treatment alone, and finally, that the combination treatment resulted in significant reduction in MDSCs, whose presence plays a predominant role in suppressing the immune system associated with tumor progression and metastases in animal models. So taken together, this pre-clinical data reinforces our belief that bavituximab treatment is capable of converting non-responding anti-PD-1 therapy patients into clinical responders.
CFO Paul Lytle:
Turning to our financials, it’s important to note that we continue to closely manage our operations in line with our cash position while balancing our various sources of capital. One important source of capital is derived from our contract mfg. business, Avid Bioservices, which generated $6.3mm in revenue this qtr and we anticipate that contract mfg. revenue will be $19-23mm for the full FY (fye 4-30-15), in line with our previous guidance. Based on the success of our contract mfg. business, today we announced strategic plans to expand our mfg. capacity for Avid Bioservices. The new capacity will help meet both the increased demand of this growing business, as well as creating sufficient mfg. capacity for the potential commercial launch of bavituximab.
As a quick backdrop, the success of our client’s products and their immediate and anticipated mfg. needs have been extremely positive for growing this business. We are now at a time where we have anticipated manufacturing needs and exceed our current available capacity. So therefore, our choices are to either outsource our bavituximab mfg. needs to a 3rd-party manufacturer and incur addl. expenses, or to expand our internal mfg. capacity. Being mindful of our capital, we performed a thorough analysis to compare the cost of adding new internal mfg. capacity vs. the cost of outsourcing this capacity specifically focused on bavituximab only. Our cost benefit analysis clearly points to adding new internal capacities that will not only support the potential commercialization of bavituximab, but should also have tremendous upside from our contract mfg. business. Let me share a few highlights of this new commercial mfg. facility that is beginning to take shape. First, the new mfg. cleanroom & infrastructure will be placed in a vacant warehouse, where we recently leased ~40,000sf. 2nd, the leased space is located adjacent to our existing mfg. facility. This will help us achieve operational efficiencies and will help minimize overlapping costs that would be incurred with a distinct facility. 3rd, the new clean room design will utilize a more efficient and cost-effective disposable technology. This is a leading trend in biomanufacturing and does not require the massive utilities that are needed with traditional mfg. facilities. It is also important to note that the cost of building a mfg. cleanroom that utilizes disposable one-time use technology is a small fraction of traditional facilities. From a capacity standpoint, the commercial facility will accommodate multiple single-use bioreactors up to 2000L in size. On a volume basis, this facility can more than double our existing capacity and allow for continued growth at Avid while meeting our bavituximab mfg. needs. Again, we took great care in making this decision, as we followed a careful cost-benefit analysis of this initiative, and we look forward to bringing those new capacities online in mid-2015.
Turning to our statements of operations, we saw an expected increase in our net loss this quarter compared to the same period last year as we continue to execute on advancing the Phase III SUNRISE trial. As we invested in the Phase III trial, R&D spends increased to approximately ~$10mm this qtr, thereby increasing our net loss to ~$12mm. As a result, we saw a similar increase in our net cash burn from operations to $9.9mm this qtr, representing our net loss minus non-cash expenses. Our financial goals are centered on maintaining a solid cap position and investing these proceeds into our novel Immuno-Oncology program lead by bavituximab and our revenue generating mfg. business. We will closely manage our operations in line with our cap position, while balancing our sources of capital. We look forward to keeping your updated on our progress.
Q&A: [24:24 mark]
1. Roy Buchanan for Charles Duncan – Piper Jaffray [http://www.piperjaffray.com – 3-5-13 Initiates PPHM: http://tinyurl.com/bxhntk3 ]
RB: ”Hi, guys. This is Roy in for Charles… On the mfg. facility, I know you said it’s a fraction of the standard facility, but can you give us a rough est. of how much it will cost and when that will start showing up in the income statements?”
Paul Lytle: If you look at 10-Q, so far we have incurred about $2mm in construction & progress related to this facility. From a competitive standpoint, we’re not going to provide any addl. projections, but what I can say is that the cost of outsourcing our mfg. needs is fairly equivalent to the cost of building this facility with tremendous upside from the mfg. side of our business and also the upside of controlling our manufacturing destiny.
RB: ”Can you breakdown how much of the capacity is going to be used for bavi vs. contract mfg?”
Steve King: Upfront, bavituximab would require only a portion of the capacity, of course. We do have the ability to continue to expand the facility, so we do anticipate it will be adequate to handle bavituximab’s market introduction as well as other potential clients in a facility at the same time.
2. Joe Pantginis – Roth Capital Partners: [ http://www.roth.com & https://roth2.bluematrix.com/docs/pdf/BLUE.pdf ]
JP: ” Hey, guys… On the capacity expansion, what capacity do you have right now bavi-wise; how far can that get you? You obviously have enough capacity to supply your Phase III; what level of early commercialization if approved?”
Steve King: Obviously we’ve been manufacturing bavituximab in our existing facility; it’s been more adequate to provide clinical supplies for all of our ongoing studies and so those are already taking care of. I think the current facility will continue to support all clinical developments up until such time as the new facility is available. It’s anticipated that we would launch out of the new facility; that that would probably pretty close to fully support all the current indications that are underway. Now, of course, it’s going to be driven by clinical data and demand and what have you, but we do think we can launch out of this facility, meet early commercialization demands and with addl. capacity still for continuing to grow the Avid business. So, we do anticipate that there will be good opportunities as we go forward for new clients to come in or even existing clients to potentially move over and become part of fully utilizing that new facility. So, as Paul mentioned, we think it’s really a win-win. It keeps us on track for bavituximab commercialization as well as on track for growing the Avid business.
JP: ”If I could just switch gears to the Breast cancer indication, obviously you’re doing a lot of background work as you mentioned discussing with KOLs and discussing potential plans. So I guess using your words, ‘pending resources’ - based on all of this background work that you’re doing, how quickly could you go into more advance programs?”
Steve King: We have obviously already generated a significant amount of data in breast cancer in combination with both paclitaxel and docetaxel. Paclitaxel data was presented at ASCO, not this last year but the year before. So I think we have adequate information to drive into that sort of combination. Now, outside of chemotherapy combinations, combinations with other Immuno-Oncology agents in the Breast cancer space are also attractive, given the fact that we already have generated some positive data with bavi in that disease setting. So, we’re in a position where you know really, in a few different ways, we could move into the clinic. We just want to make sure we have the adequate resources to completely fund any study we start. So we’re looking into the trial design, the size of the trials; it’s always the possibility for things like Phase II, III studies and what have you, that kind of have 2 different components which makes them from a funding standpoint easier to just swallow upfront.
3. George Zavoico (MLV & Co.): http://www.mlvco.com
GZ: ” Hi… Question about Avid - you mentioned going forward your increasing capacity, does this mean you are expanding on your customer mix? Do you have the some new customers there? 2nd, re: switching over to the disposable technology, does that being another set of regulatory hurdles you need to cross to go from non-disposable to disposable? Lastly, just want to make sure I understand, you’re not filling the 40,000sq right now; you have room to expand in the future?”
Steve King: That’s correct. The bottom line is that we have seen expansion of our mix of customers, which is absolutely driving a lot of the need for considering new capacity, because we’ve being getting closer & closer to max capacity in the existing facility. Re: question #2, we’ve already been manufacturing in our existing facility in both stainless steel and single-use bioreactors, and in fact we have the ability to manufacture bavituximab in either one. So from a regulatory standpoint, it’s one of the goals of doing the facility expansion is actually to be able to keep almost identical systems to what we have been manufacturing bavituximab, to very much limit any regulatory risk. That’s been the primary goal of this new facility, going with disposable systems, they almost exactly mirror what we’re already producing bavi in, and what we make bavi for the Phase III in.
GZ: ”Over the I-O space, a general question both with regard to pre-clinical experiments you may have done, and also the carbo/pemetrexed trial - one of the key features of IO space obviously is that a significant, but small fraction of, patients have a durable response. Do you any evidence of that, do you see any evidence of that in any of your preclinical or clinical studies yet?”
Steve King: I can start off, and I’ll hand it over to Jeff, but that’s one of the things that is most exciting about the information we’re learning about program, because what we’re seeing is that if you look at in pre-clinical models, which mirrors pretty much the patient situation, that really it’s still in some of the systems a minority of the subjects in the study which actually end up having good anti-tumor effects. And what we’re seeing when you add bavituximab to whether it be PD-1 or CTLA-4, what we’re seeing is now that more of the subjects actually respond. So, it’s not necessarily making it work better and the subjects started working great again, but it’s really turning those non-responders into responders. I’ll hand over Jeff to expand on that.
Jeff Hutchins: We’ve been very careful as we present this data to not show averages just exactly to this point, at least in smaller squares that when we present data we show the individual animals and how they are responding. It’s exactly what Steve said, it’s the animals in this case that we’re bringing into the active treatment response that is really driving our excitement. When a patient or an animal responds to anti-PD-1 mono-therapy in a good way, it happens and they go on to a cure. So that’s kind of what we’re seeing - we’re after 60-80% of patients aren’t responding to the current checkpoint therapy in these models.
Steve King: If you look at the translational data from the Liver cancer study as presented in SITC, in the patients in which we did the analysis, we saw several patients that went from being low or negative PD-1, PDL-1 levels to being positive, and we know that PD-1 status positive is associated with good outcome on PD-1 therapy and negative associated with poor outcome. It’s exciting, the fact that we may be able to have our 1st evidence that we’re able to convert patients over from being negative to positive with regard to PD-1 status. So, early studies, limited number of patients, but we’re continuing to expand that out. It’s off to an exciting start, and everyone who has looked at the data has been pretty happy with it.
GZ: ”You talked about the SITC conference [SITC’14/Nov7-8) http://tinyurl.com/pchzr6h ], and you’re clearly going to a lot of conferences now. So the education as it were of the stakeholders, the caregivers of bavi being an immune checkpoint; it seems like you’re making much better progress now than you did a year ago when you first started out. Can you comment on how that’s going?”
Steve King: We’re much more active out in the immuno-oncology conferences where thought leaders were meeting. We’ve been getting more & more recognition of the role of the Phosphatidylserine (PS) immunosuppressive pathway and its role in controlling the immune system. When you really look at even the PS, PS receptors, there’s actually a lot of activity from other companies even in this space and we are by far the most advanced company or program looking at that particular target. So yes, it’s a lot of work; being at the conferences, making presentations, getting those interaction points. But secondly, it’s actively working with some of the KOLs in this area, and we are collaborating on several of these programs we’ve talked about with well-known, well-respected individuals in the I-O space, and that’s the other key, to get them to have the positive experience in their hands. And, that’s all underway. We’ve made great progress and we going to keep that until it’s a household name in the I-O space.
GZ: ”I wish you continued good luck in that. Thanks a lot.”
MR. KING’S CLOSING COMMENTS:
I’d like to thank all of you again for participating in today’s call. As was mentioned at several points today, our mission is to advance our novel immunotherapy while understanding its full potential in multiple indications. The framework for this mission has resulted in a late-stage clinical program, the SUNRISE trial. Now, with the work we are currently doing, including much of the activities that you have been seeing over the past several quarters from our immuno-oncology development program as well as proposals for clinical programs, we look forward to further strengthening this framework.
All of this pre-clinical & translational work is important in order to chart the next clinical course, as well as serving at the further validation of the immune-stimulatory mechanism of action that the founder of our technology, the late Dr. Phil Thorpe, was such a champion of. We feel strongly in our mission and believe in its value and that that value will be reflected in our share price as company milestones are reached. Thank you all for your support and have a great holiday season.
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12-10-14 PR: “Peregrine Pharmaceuticals Reports 2nd Quarter FY2015 Financial Results and Recent Developments”
• SUNRISE Phase III Lung Cancer Trial for Peregrine's Lead Immuno-Oncology Candidate Bavituximab Operational at Over 150 Sites Worldwide
• Data From Immuno-Oncology Development Program Shows Potential of Bavituximab to Significantly Enhance Checkpoint Inhibitors Anti-PD-1 and Anti-CTLA-4 in Multiple Preclinical Models
• Avid Bioservices Announces Expansion of Manufacturing Capacity to Support the Potential Commercial Launch of Bavituximab and Growth of Contract Manufacturing Business
TUSTIN, CA - 12/10/14: Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM, PPHMP), a biopharmaceutical company focused on advancing bavituximab, a new immuno-oncology antibody targeting the highly immunosuppressive phosphatidylserine (PS) signaling pathway, towards commercialization and providing integrated cGMP clinical and commercial bio-manufacturing services, today announced financial results for the second quarter of fiscal year (FY) 2015 ended October 31, 2014. The company also provided an update on its advancing clinical pipeline and reviewed other corporate developments.
"Our product development activities are dedicated to bringing bavituximab, the lead clinical compound targeting the inhibitory PS signaling pathway, to the market in order to address the unmet medical needs of cancer patients," said Steven W. King, president and chief executive officer of Peregrine. "Our lead effort towards this goal is the advancement of our bavituximab Phase III SUNRISE trial in non-small cell lung cancer, which is now open for enrollment at over 150 centers worldwide, with an anticipated completion of enrollment by the end of calendar year 2015. We have also made great strides in exploring new oncology opportunities including promising immuno-oncology combinations pairing bavituximab with PD-1 and CTLA-4 targeting agents resulting in significant therapeutic improvements in multiple preclinical cancer models. The combination of immuno-oncology agents has the potential to completely change the treatment paradigm for cancer patients and we feel bavituximab is in an excellent position to be a significant player in future immuno-oncology combination treatment options. On the contract manufacturing side of our business, we continued to see solid performance with $6.3 million in contract manufacturing revenues generated for the second quarter. We believe Avid has significant growth potential and in order to realize this, we are more than doubling our current biomanufacturing capacity."
The company's mission is to develop a brand new class of immunotherapies focused on the clinical advancement of our lead drug candidate bavituximab which targets the immunosuppressive PS signaling pathway. Bavituximab has the potential to be an effective part of treatment regimens in many different tumor types and has recently shown promise in combination with other immuno-oncology compounds. Over the past quarter, the company has made important progress in bringing this novel immunotherapy closer to the market led by the SUNRISE Phase III clinical trial.
The company has continued to open trial sites, now totaling over 150 worldwide, and to 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. The primary endpoint of the trial is overall survival. For additional information about the SUNRISE trial, please visit http://www.sunrisetrial.com or http://ClinicalTrials.gov using the Identifier NCT01999673. [ http://www.clinicaltrials.gov/ct2/show/NCT01999673 ]
The company's commitment to exploring the full clinical potential of bavituximab in combination with chemotherapies or other immuno-oncology agents is being executed through a series of Investigator-Sponsored Trials (IST) in multiple solid tumor indications. The following represents anticipated upcoming data from ongoing or completed clinical studies as well as the status of trials that can yield data in the future:
• Final data from a Phase I IST that evaluated bavituximab in combination with paclitaxel in patients with HER2-negative metastatic breast cancer has been submitted for publication and the company is currently evaluating opportunities to advance the clinical development of bavituximab in breast cancer.
• Data from a Phase I/II IST that evaluated bavituximab in combination with sorafenib in patients with advanced hepatocellular carcinoma (liver cancer) has been accepted for poster presentation at the 2015 Gastrointestinal Cancers Symposium to be held January 15-17, 2015 in San Francisco, California [ http://tinyurl.com/q5dyruw ] and for an oral presentation at the Society of Surgical Oncology's 68th Annual Cancer Symposium to be held March 25-28, 2015 in Houston, Texas [ http://events.jspargo.com/SSO15/public/enter.aspx ].
• Data from a Phase Ib IST that evaluated bavituximab in combination with carboplatin and pemetrexed in patients with previously untreated Stage IV NSCLC was presented at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology[MSTO’14/Oct30 http://tinyurl.com/oz4w3zn ]. In this single-arm trial, patients treated with bavituximab in combination with carboplatin and pemetrexed achieved an overall response rate (ORR) of 35%, a median progression free survival (PFS) of 4.8 months and a median overall survival (OS) of 12.2 months. Favorable trends in ORR and OS as well as tolerability continue to support the potential of bavituximab in NSCLC.
• A Phase I IST evaluating bavituximab in combination with capecitabine and radiation therapy in up to 18 patients with Stage II or III rectal adenocarcinoma is open for patient enrollment.
• A Phase Ib IST evaluating bavituximab in combination with Bristol-Myers Squibb's ipilimumab (Yervoy®) in up to 24 patients with advanced melanoma is open for patient enrollment.
As part of the company's mission to discover the full potential of its immunotherapy bavituximab in clinical disease applications, the company is advancing studies through its Immuno-Oncology Development Program. This program was designed to explore the potential of combining bavituximab with other immunotherapies, experimental immuno-oncology drugs including checkpoint inhibitors, as well as vaccines.
Data was recently presented at the Cancer Research Institutes' (CRI) "Cancer Immunotherapy: Out of the Gate" and the Society for Immunotherapy of Cancer's (SITC) 29th Annual Meeting and Associated Programs conferences [CRI’14/Immun/Oct6 http://tinyurl.com/nkjlxep ]. Data from the conferences show that tumor growth was significantly slowed in multiple aggressive tumor models of melanoma and breast cancer when combining ch1N11, the preclinical equivalent to bavituximab, with anti-CTLA-1 and anti-PD-1 agents compared to anti-CTLA-1 and anti-PD-1 agents alone. These data further support the combination of bavituximab and other immune checkpoint inhibitors.
Clinical translational data from six patients from the company's Immuno-Oncology Development Program in conjunction with the Phase II IST that evaluated bavituximab in combination with sorafenib in patients with advanced hepatocellular carcinoma was presented at the SITC 29th Annual Meeting [SITC’14/Nov7-8) http://tinyurl.com/pchzr6h ]. These data, to assess and measure changes in immune response pre- and post-treatment, show an increase in tumor fighting immune cells (particularly CD8 T cells) following one cycle of treatment with bavituximab, further confirming in patients what has been shown for PS-targeting antibodies in multiple preclinical cancer models.
Preclinical data from recently conducted studies will be presented in a poster titled: "Antibody-mediated Blockade of Phosphatidylserine Enhances the Anti-tumor Activity of Immune Checkpoint Inhibitor a-PD-1 by Affecting Myeloid Derived Suppressor Cells (MDSC) and Lymphocyte Populations in a Breast Tumor Microenvironment" at the 2014 San Antonio Breast Cancer Symposium on December 12, 2014 in San Antonio, Texas [SanAntonio’14/Dec12 http://tinyurl.com/p5ng6vs ].
The company is also exploring other applications for the PS-targeting platform outside of cancer therapy. These efforts include:
PS-TARGETING MOLECULAR IMAGING PROGRAM
The company is exploring the potential of its experimental PS-targeting molecular imaging candidate, 124I-PGN650, in patients with various solid tumor types. This is an open-label, single-center trial with a primary goal of estimating radiation dosimetry in critical and non-critical organs and secondary objectives of tumor imaging and safety.
ANTI-VIRAL PROGRAM
The company announced the publication of a manuscript in the Vaccines and Therapies for Biodefense Agents special edition of the peer-reviewed Journal of Immunology Research [ http://tinyurl.com/mv34bq5 ]. The paper discusses preclinical research demonstrating that the company's lead drug candidate bavituximab exhibits specific and strong binding to Ebola virions and Ebola virus-infected cells in vitro. These data warrant further collaborative investigation in Ebola and other infectious diseases including combinations with vaccines and active therapies that have shown promise.
AVID BIOSERVICES
Avid Bioservices, Inc. is the contract manufacturing subsidiary of Peregrine. Avid provides high quality clinical and commercial manufacturing services under cGMP for the biotechnology and biopharmaceutical industries. In a press release issued this morning [12-10-14 http://tinyurl.com/mmc3qgy ], the company announced the initiation of an expansion of manufacturing capacity for Avid Bioservices that will help meet the increased demands of this growing business while creating sufficient capacity for the commercial manufacturing of bavituximab. This facility will employ an innovative and flexible modular clean room design and the latest single-use technologies that provide expanded capacity to meet the growing needs of Avid's existing and future clients. The capacity expansion will take place within an existing 40,000 square foot warehouse located adjacent to the company's current campus. The new cGMP facility will accommodate multiple single-use bioreactors of up to 2,000 liters, downstream processing suites, and dedicated support utilities that will allow for the production of a variety of biological products.
"The success of our contract manufacturing business has led us to evaluate strategic options to expand our manufacturing capacity that will support the future growth of our manufacturing business as well as the anticipated commercial launch of bavituximab," said Paul Lytle, CFO of Peregrine. "This facility will allow us to achieve both of these stated goals in the most efficient and cost effective manner."
FINANCIAL RESULTS
Total revenues for the second quarter of FY 2015 were $6,300,000, compared to $7,354,000 for the same quarter of the prior fiscal year. The decrease was primarily attributed to a decrease 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 second quarter FY 2015 were $6,263,000, compared to $7,354,000 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 second quarter of FY 2015 were $18,437,000, compared to $15,168,000 in the second quarter of FY 2014. This increase was primarily attributable to the current quarter increase in research and development expenses associated with the SUNRISE Phase III trial combined with an incremental increase in selling, general and administrative expenses. For the second quarter FY 2015, research and development expenses were $10,003,000, compared to $6,957,000 for the second quarter of FY 2014. For the second quarter of FY 2015, selling, general and administrative expenses were $4,295,000, compared to $4,016,000 for the second quarter of FY 2014.
Peregrine's consolidated net loss attributable to common stockholders was $13,131,000, or $0.07 per share, for the second quarter of FY 2015, compared to a net loss attributable to common stockholders of $7,790,000, or $0.05 per share, for the same quarter of the prior year.
Peregrine reported $64,439,000 in cash and cash equivalents as of October 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. [ http://tinyurl.com/m6ldhg7 ]
CONFERENCE CALL
Peregrine will host a conference call and webcast this afternoon, December 10, 2014, at 4:30 PM EST (1:30 PM PST). To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Peregrine Pharmaceuticals conference call. To listen to the live webcast, or access the archived webcast, please visit: http://ir.peregrineinc.com/events.cfm .
ABOUT PEREGRINE PHARMACEUTICALS, INC.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a pipeline of novel drug candidates in clinical trials for the treatment and diagnosis of cancer. The company's lead immunotherapy candidate, bavituximab is in Phase III development for the treatment of second-line non-small lung cancer (the "SUNRISE trial") along with several investigator-sponsored trials evaluating other treatment combinations and additional oncology indications. The company is also advancing a molecular imaging agent, 124I-PGN650, in an exploratory clinical trial for the imaging of multiple solid tumor types. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com ), which provides development and biomanufacturing services for both Peregrine and third-party customers. Additional information about Peregrine can be found at http://www.peregrineinc.com .
Safe Harbor *snip*
Yervoy is a registered trademark of Bristol-Myers Squibb.
Contact: Christopher Keenan, Peregrine Pharmaceuticals, Inc., (800) 987-8256 - info@peregrineinc.com
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
Three Months Ended
October 31, Six Months Ended
October 31,
2014 2013 2014 2013
Unaudited Unaudited Unaudited Unaudited
REVENUES:
Contract manufacturing revenue $ 6,263,000 $ 7,354,000 $ 11,759,000 $ 11,935,000
License revenue 37,000 - 37,000 107,000
Total revenues 6,300,000 7,354,000 11,796,000 12,042,000
COSTS AND EXPENSES:
Cost of contract manufacturing 4,139,000 4,195,000 7,722,000 6,865,000
Research and development 10,003,000 6,957,000 20,204,000 12,261,000
Selling, general and administrative 4,295,000 4,016,000 9,178,000 8,350,000
Total costs and expenses 18,437,000 15,168,000 37,104,000 27,476,000
LOSS FROM OPERATIONS (12,137,000 ) (7,814,000 ) (25,308,000 ) (15,434,000 )
OTHER INCOME (EXPENSE):
Interest and other income 37,000 24,000 79,000 45,000
Interest and other expense - - - (1,000 )
NET LOSS $ (12,100,000 ) $ (7,790,000 ) $ (25,229,000 ) $ (15,390,000 )
COMPREHENSIVE LOSS $ (12,100,000 ) $ (7,790,000 ) $ (25,229,000 ) $ (15,390,000 )
Series E preferred stock accumulated dividends (1,031,000 ) - (1,802,000 ) -
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS $ (13,131,000 ) $ (7,790,000 ) $ (27,031,000 ) $ (15,390,000 )
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:
Basic and Diluted 179,962,275 156,948,226 179,540,265 153,170,928
BASIC AND DILUTED LOSS PER COMMON SHARE $ (0.07 ) $ (0.05 ) $ (0.15 ) $ (0.10 )
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
OCTOBER 31,
2014 APRIL 30,
2014
Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 64,439,000 $ 77,490,000
Trade and other receivables, net 3,361,000 1,332,000
Inventories 5,379,000 5,530,000
Prepaid expenses and other current assets, net 1,189,000 1,419,000
Total current assets 74,368,000 85,771,000
Property and equipment, net 5,398,000 2,447,000
Other assets 1,671,000 2,327,000
TOTAL ASSETS $ 81,437,000 $ 90,545,000
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 3,840,000 $ 2,434,000
Accrued clinical trial and related fees 2,537,000 4,433,000
Accrued payroll and related costs 3,472,000 3,837,000
Deferred revenue, current portion 3,612,000 5,241,000
Customer deposits 7,549,000 5,760,000
Other current liabilities 572,000 502,000
Total current liabilities 21,582,000 22,207,000
Deferred revenue, less current portion - 292,000
Other long-term liabilities 1,078,000 347,000
Commitments and contingencies
STOCKHOLDERS' EQUITY:
Preferred stock-$0.001 par value; authorized 5,000,000 shares; issued and outstanding -- 1,177,858 and 775,000, respectively 1,000 1,000
Common stock-$0.001 par value; authorized 325,000,000 shares; outstanding -- 182,000,583 and 178,871,164, respectively 182,000 179,000
Additional paid-in capital 487,089,000 470,785,000
Accumulated deficit (428,495,000 ) (403,266,000 )
Total stockholders' equity 58,777,000 67,699,000
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 81,437,000 $ 90,545,000
- - - - - - - - -
[ From 10-Q header: “As of Dec. 5, 2014, there were 182,081,234 shares of issuer’s common stock.”
- - - - - - - - - - - - - - - - -
Latest 10K 4-30-14 iss. 7-14-14: http://tinyurl.com/mhva3k3 PR: http://tinyurl.com/o2e4a4g (Cash 4-30-14=$77.5mm)
Latest 10Q 10-31-14 iss. 12-10-14 http://tinyurl.com/m6ldhg7 PR: http://tinyurl.com/kmdgq8t (Cash 10-31-14=$64.4mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
.
.
= = = = = = = = = = = = = = = = = = = = = = = = = = = =
Updated PPHM REVS-BY-QTR TABLE, now thru FY15/Q2 (qe 10-31-14), per the 10-31-14 10-Q ( http://tinyurl.com/m6ldhg7 ) issued 12-10-14. Deferred-Revs at 10-31-14, going fwd into FY’15/Q3 (q/e 1-31-15), total $3.6mm, down from the $4.7mm of Deferred-Revs at 7-31-14 that drove into FY’15/Q2.
Total Revs since May’06: ($114.2mm/Avid + $24.1mm/Govt + $2.1mm/Lic.) = $140.5mm
==> Recall, Avid Rev$ from Gov’t DTRA Contract work (6/30/08 – 4/15/11, totaling $24.15mm), went into GOVT-REVS, not AVID-REVS, in the Financials.
Avid’s website: http://www.avidbio.com
AVID PROFITABILITY (GROSS*) BY QTR:
QTR Avid-Rev$ CostofMfg$ Gross-Profit$ GM%
FY13Q1 7-31-12 4,135,000 2,024,000 2,111,000 51%
FY13Q2 10-31-12 6,061,000 3,703,000 2,358,000 39%
FY13Q3 1-31-13 6,961,000 3,651,000 3,310,000 47%
FY13Q4 4-30-13 4,176,000 3,217,000 959,000 23%
FY13 TOTAL: 21,333,000 12,595,000 8,738,000 41%
FY14Q1 7-31-13 4,581,000 2,670,000 1,911,000 42%
FY14Q2 10-31-13 7,354,000 4,195,000 3,159,000 43%
FY14Q3 1-31-14 3,885,000 2,416,000 1,469,000 38%
FY14Q4 4-30-14 6,474,000 3,829,000 2,645,000 41%
FY14 TOTAL: 22,294,000 13,110,000 9,184,000 41%
FY15Q1 7-31-14 5,496,000 3,583,000 1,913,000 35%
FY15Q2 10-31-14 6,263,000 4,139,000 2,124,000 34%
*Avid Net-Profit (ie, incl. Selling, G&A) not split out from PPHM-Corp. in the financials.
.
PPHM REVENUES (in thousands) DEFERRED
-------REVENUES------- REVENUES INVEN-
Quarter Avid Govt Lic. TOTAL Avid Govt TORIES
FY07Q1 7-31-06 398 0 23 421 317 0 971
FY07Q2 10-31-06 636 0 48 684 1388 0 1899
FY07Q3 1-31-07 347 0 16 363 2202 0 1325
FY07Q4 4-30-07 2111 0 129 2240 1060 0 1916
FY08Q1 7-31-07 1621 0 4 1625 1820 0 2363
FY08Q2 10-31-07 1863 0 29 1892 1338 0 3500
FY08Q3 1-31-08 1662 0 13 1675 1434 0 2394
FY08Q4 4-30-08 751 0 150 901 2196 0 2900
FY09Q1 7-31-08 1193 324 0 1517 4021 980 4628
FY09Q2 10-31-08 983 958 0 1941 6472 1701 6700
FY09Q3 1-31-09 5778 1048 0 6826 4805 3262 5547
FY09Q4 4-30-09 5009 2683 175 7867 3776 3871 4707
FY10Q1 7-31-09 2070 4671 9 6750 5755 2332 6177
FY10Q2 10-31-09 5308 1510 78 6896 4260 3989 5850
FY10Q3 1-31-10 2945 6854 78 9877 3052 76 3861
FY10Q4 4-30-10 2881 1461 78 4420 2406 78 3123
FY11Q1 7-31-10 983 2111 115 3209 3719 47 4692
FY11Q2 10-31-10 3627 966 78 4671 2447 35 3555
FY11Q3 1-31-11 1922 882 79 2883 4300 40 3915
FY11Q4 4-30-11 1970 681 78 2729 5617 0 5284
FY12Q1 7-31-11 5439 0 216 5655 4145 0 4481
FY12Q2 10-31-11 4154 0 78 4232 2012 0 3178
FY12Q3 1-31-12 3203 0 78 3281 2552 0 2722
FY12Q4 4-30-12 1987 0 78 2065 3651 0 3611
FY13Q1 7-31-12 4135 0 116 4251 6056 0 5744
FY13Q2 10-31-12 6061 0 78 6139 6221 0 5426
FY13Q3 1-31-13 6961 0 78 7039 5061 0 4635
FY13Q4 4-30-13 4176 0 78 4254 4171 0 4339
FY14Q1 7-31-13 4581 0 107 4688 4164 0 5679
FY14Q2 10-31-13 7354 0 0 7354 3468 0 4033
FY14Q3 1-31-14 3885 0 0 3885 4329 0 5224
FY14Q4 4-30-14 6474 0 0 6474 5241 0 5530
FY15Q1 7-31-14 5496 0 0 5496 4670 0 5998
FY15Q2 10-31-14 6263 0 37 6300 3612 0 5379
Totals: 114227 24149 2124 140500 <=since5/1/2006
.
TOTAL REV’s BY YEAR (Avid+Gov’t+Lic):
FY04 4-30-04 3,314 …Avid(CMO)= 3,039 (Avid-Revs don’t incl. Govt-SVCS)
FY05 4-30-05 4,959 …Avid(CMO)= 4,684
FY06 4-30-06 3,193 …Avid(CMO)= 3,005
FY07 4-30-07 3,708 …Avid(CMO)= 3,492
FY08 4-30-08 6,093 …Avid(CMO)= 5,897
FY09 4-30-09 18,151 …Avid(CMO)= 12,963
FY10 4-30-10 27,943 …Avid(CMO)= 13,204
FY11 4-30-11 13,492 …Avid(CMO)= 8,502
FY12 4-30-12 15,233 …Avid(CMO)= 14,783
FY13 4-30-13 21,683 …Avid(CMO)= 21,333
FY14 4-30-14 22,401 …Avid(CMO)= 22,294
...Total Gov’t Revs from 7-2008 inception thru FY11Q1(Apr’11): $24.15mm
.
AVID “Total Services”:
AVID OUTPUT$ 3rd-PARTY + PEREGRINE = TOTAL-OUTPUT$
FY09 4-30-09 13mm 10mm $23mm #
FY10 4-30-10 13mm 17mm $30mm #
FY11 4-30-11 9mm 11mm $20mm @
FY12 4-30-12 15mm 11mm $26mm @
FY13 4-30-13 21mm ~10mm ~$31mm ^
LTM ended 1/2010 3rd/$15.3mm + Govt/$8.3mm + PPHM/$8.8mm = $32.4mm *
@SKing 3-18-2013 RothOC/DanaPT (Slide21) http://tinyurl.com/cebtwen
#SKing 7-12-2012 JMP/NYC Conf. (Slide27) http://tinyurl.com/csdclwb
*SKing 3-17-2010 RothOC/DanaPT Conf. (Slide18) http://tinyurl.com/ye9v7jq
^PLytle 7-11-2013 Qtly-CC “Avid did ~$10mm in equivalent services for Peregrine in FY13, which doesn’t get reflected into the fin. statements, it's eliminated in consolidation.”
.
PPHM’S QTLY. NET LOSS BY QTR:
FY08Q1 7-31-07 4,656,000
FY08Q2 10-31-07 6,207,000
FY08Q3 1-31-08 6,154,000
FY08Q4 4-30-08 6,159,000
FY09Q1 7-31-08 5,086,000
FY09Q2 10-31-08 4,497,000
FY09Q3 1-31-09 3,332,000
FY09Q4 4-30-09 3,609,000
FY10Q1 7-31-09 2,428,000
FY10Q2 10-31-09 2,787,000
FY10Q3 1-31-10 1,538,000
FY10Q4 4-30-10 7,741,000
FY11Q1 7-31-10 7,695,000
FY11Q2 10-31-10 7,513,000
FY11Q3 1-31-11 8,929,000
FY11Q4 4-30-11 10,014,000
FY12Q1 7-31-11 8,092,000
FY12Q2 10-31-11 12,055,000
FY12Q3 1-31-12 11,090,000
FY12Q4 4-30-12 10,882,000
FY13Q1 7-31-12 7,664,000
FY13Q2 10-31-12 8,753,000
FY13Q3 1-31-13 4,914,000
FY13Q4 4-30-13 8,449,000
FY14Q1 7-31-13 7,600,000
FY14Q2 10-31-13 7,790,000
FY14Q3 1-31-14 9,724,000
FY14Q4 4-30-14 10,248,000
FY15Q1 7-31-14 13,129,000
FY15Q2 10-31-14 12,100,000
.
= = = = = = =
OPER. CASH BURNS* BY QTR(FROM THE 10-Q/K’S):
FY10Q1 7-31-09 2,024,000 (from 10Q pg.25)
FY10Q2 10-31-09 2,351,000 (Q1+Q2: 4,375,000 pg.28)
FY10Q3 1-31-10 1,158,000 (Q1+Q2+Q3: 5,533,000 pg.30)
FY10Q4 4-30-10 6,375,000 (FY’10: 11,908,000 10K pg.58)
FY11Q1 7-31-10 6,567,000 (from 10Q pg.24)
FY11Q2 10-31-10 6,167,000 (Q1+Q2: $12,734,000 pg.25)
FY11Q3 1-31-11 7,736,000 (Q1+Q2+Q3: $20,470,000 pg.26)
FY11Q4 4-30-11 8,961,000 (FY’11: 29,431,000 10K pg.54)
FY12Q1 7-31-11 6,984,000 (from 10Q pg.25)
FY12Q2 10-31-11 11,668,000 (Q1+Q2: 18,652,000 pg.25)
FY12Q3 1-31-12 8,490,000 (Q1+Q2+Q3: 27,142,000 pg.25)
FY12Q4 4-30-12 11,265,000 (FY’12: 38,407,000 10K pg.55)
FY13Q1 7-31-12 6,742,000 (from 10Q pg.21)
FY13Q2 10-31-12 6,162,000 (Q1+Q2: 12,904,000 pg.23)
FY13Q3 1-31-13 3,597,000 (Q1+Q2+Q3: 16,501,000 pg.23)
FY13Q4 4-30-13 7,053,000 (FY’13: 23,554,000 10K pg.60)
FY14Q1 7-31-13 5,750,000 (from 10Q pg.23)
FY14Q2 10-31-13 5,834,000 (Q1+Q2: 11,584,000 10Q pg.24)
FY14Q3 1-31-14 7,875,000 (Q1+Q2+Q3: 19,459,000 10Q pg.26)
FY14Q4 4-30-14 8,706,000 (FY’14: 28,165,000 10K pg.55)
FY15Q1 7-31-14 11,076,000 (from 10Q pg.23)
FY15Q2 10-31-14 9,947,000 (Q1+Q2: 21,023,000 10Q pg.25)
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)
FY’15-Q2 = q/e 10-31-14 – rep. 12-10-14 Wed (after mkt)
= = = = = = = = = = = =
“Going Concern” statement ELIMINATED from 4-30-13 10-K issued 7-11-2013…
2012: 4-30-12 10-K iss. 7-16-12 http://tinyurl.com/79o57b2
Pg.68: “As more fully described in Note 2, the Company’s recurring losses from operations and recurring negative cash flows from operating activities raise substantial doubt about its ability to continue as a going concern.”
2013 & 2014 10-K's: http://tinyurl.com/p58jcbw & http://tinyurl.com/mhva3k3 ==> ((((NO GOING CONCERN STATEMENT INCLUDED.))))
CASH a/o 4-30-13: $35.2mm
CASH a/o 6-30-13: $42.6mm
CASH a/o 7-31-13: $41.6mm
CASH a/o 10-31-13: $44.4mm
CASH a/o 1-31-14: $63.2mm
CASH a/o 2-15-14: $79.7mm
CASH a/o 4-30-14: $77.5mm
CASH a/o 6-30-14: $78.3mm
CASH a/o 7-31-14: $73.3mm
CASH a/o 10-31-14: $64.4mm
= = = = = = = = = = 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 12-10-2014:
http://www.peregrineinc.com/images/stories/pdfs/dec_2014_corp_fact_sheet.pdf
= = = = = = = = = = = = = = =
10-16-14 Peregrine ASM: Slides(42), Audio-Replay-Link, Attendee-Reports http://tinyurl.com/oyc3e5v
9-9-14 Qtly. Conf. Call (King/Hutchins/Shan/Lytle) Transcript http://tinyurl.com/ktrfswj
...CEO S.King: “In addition to our clinical trials, many of which have also have translational data points built in to tie together pre-clin. data with the clinic, we have also continued to build momentum in our pre-clin. collaborations which now number in the dozens. We are evaluating new combinations & dosing strategies combining bavituximab with chemotherapy, radiation, and immune-oncology approaches, including those targeting CTLA-4, PD-1, as well as other downstream immune checkpoints."
7-14-14 Qtly. Conf. Call (King/Shan/Hutchins/Worsley/Lytle) Transcript http://tinyurl.com/o2e4a4g
...CEO S.King: “Partnering remains a priority with the goal being to use partnerships to continue expanding the bavituximab program, while we continue to execute the SUNRISE Phase III trial.”
3-10-14: CEO Steve King’s 22min. talk at ROTH Conf. (DanaPT CA) - SLIDES http://tinyurl.com/n65myfk
3-7-14 Qtly. Conf. Call (King/Shan/Garnick/Lytle) Transcript http://tinyurl.com/kh9cnrg
...CEO S.King: “I don't want to overuse the word ‘excitement’, but these are truly exciting times that have positioned us for success on all fronts.”
12-10-13 Qtly. Conf. Call (King/Shan/Garnick/Hutchins/Worsley/Lytle) Transcript http://tinyurl.com/mw776mk
...CEO S.King: “We believe that Peregrine is uniquely positioned among the companies developing immunotherapies… and that because of our current valuation, we represent a unique investment opportunity.
• All of Dr. Robert Garnick's public comments (thru 3-7-2014) while at Peregrine: http://tinyurl.com/obvwyuh Steve King said 6-29-11, "Rob is the ringmaster."
• 6-29-11 Minyanville article, "Peregrine Pharma's Secret Weapon [Robert Garnick]" http://tinyurl.com/9jtnan o
• Examples of Dr. Garnick's work at Genentech on Avastin (bevacizumab) approvals: http://tinyurl.com/yg7vtqa
PS-TARGETING SCIENCE: "Evolution has favored pathogenesis that resembles apoptosis."
Dr. Judah Folkman: ”This [Thorpe’s VTA research] is very promising and very elegant work... The whole goal is really 2-part, reducing the harsh side effects of cancer treatment, and reducing the chance that some cancer cells will evade treatment. That would be a big step in the next decade, and anti-vascular therapy will play a major role." (’97 & ’02 http://tinyurl.com/k5qe96g & http://tinyurl.com/n6vh9hp )
Peregrine's Bavituximab & Cotara Technologies: http://www.peregrineinc.com/technology/overview.html
Peregrine's Clinical Trials website: http://PeregrineTrials.com
- - - - - - - -
Bavituximab MOA & Clinical Data: http://www.peregrineinc.com/pipeline/bavituximab-oncology.html
...Bavi Publications: http://www.peregrineinc.com/publications/publications.html
...Bavi Posters & Presentations: http://www.peregrineinc.com/publications/posters-and-presentations.html
Bavi MOA: Video (3:34) added ~3-2014 http://vimeo.com/87116642 "Bavituximab: A Novel Immunotherapy Candidate Targeting an Upstream Immune Checkpoint to Fight Cancer"
Bavi MOA: Video (1:33) on Bavi’s Immunotherapeutic MOA added to Youtube on 3-27-14 https://www.youtube.com/watch?v=Esewl35JD8s
BAVI MOA 11-2014 SITC’14: 3 posters on preclin. Bavi+aCTLA4/aPD1 combo data (Hutchins Freimark Brekken Huang etal) http://tinyurl.com/pchzr6h
BAVI MOA 8-28-14: Italy’s Dr. Federico Cappuzzo, Bavi/NSCLC profile article (DovePress OpenAccess, 7pgs) - http://tinyurl.com/n3oa7bc
BAVI MOA 8-11-14: PPHM/VP Dr. Jeff Hutchins’ presentation at ImVacS "Immunotherapies & Vaccine Summit", Boston - PR: http://tinyurl.com/lpjy3u7 ; PDF(31 Slides): http://tinyurl.com/oueldme
...MLV’s Dr. George Zavoico’s 8-27-14 report on Dr. Jeff Hutchins’ 8-11-14 ImVacS/Boston Bavi MOA presentation: http://tinyurl.com/l3tw63c
BAVI MOA 5-28-14: Dr. Rolf Brekken’s 47min CRI “Cancer Immunotherapy” webinar about Bavituximab as an Upstream/Global Immune Checkpoint Inhibitor – REPLAY: http://tinyurl.com/lxgftyx
. . .CRI=Cancer Research Institute (NYC – Supported by BMS): http://www.cancerresearch.org - Facebook: http://tinyurl.com/pbmhb2z , https://twitter.com/CancerResearch
. . .CRI launches “Answer to Cancer” (cancer immunotherapy) website http://www.theanswertocancer.org
. . .8-12-14: CRI adds Youtube links to the 5-28-14 CRI Immunotherapy webinar, incl. Dr. Brekken's talk "about Bavi and how it works against lung, liver, and other kinds of cancers" http://tinyurl.com/ps5h6h8
BAVI MOA 3-25-14: Dr. Rolf Brekken’s 40min talk at NYAS Lung Cancer Symposium http://tinyurl.com/lq9stnk (45 Slides)
. . .Dr.Brekken’s talk: “Antibody-mediated Inhibition of PS - A Novel Strategy for Immune Checkpoint Blockade” (the 5 speakers: Jessica Donington, Roy Herbst, Balazs Halmos, Suresh Ramalingam, Rolf Brekken)
12-10-13: With recent scientific insights highlighting bavi’s immunostimulatory moa, these additions to PPHM’s SAB: Dimitry Gabrilovich, Scott Antonia, David Carbone**, Hakan Mellstedt http://tinyurl.com/mw776mk
......**A/o 9-2014, Dr. David Carbone (PPHM SAB/KOL) is President-Elect of IASLC https://www.iaslc.org/about-us/board
BAVI MOA: 12-2013 Bavi’s Immunotherapeutic MOA overviewed by UTSW’s Brekken/Huang in Pan European Networks Jrnl. http://tinyurl.com/lnb46pq
BAVI MOA 11-9-13: Annual SITC (WashDC) – 2 posters about Bavi’s Immunostimulatory MOA http://tinyurl.com/mjaweu5
...“We are actively working towards initiating a clinical trial in the coming months to further investigate the potential synergistic effects of bavituximab and an approved [anti-CTLA-4] immunotherapy in patients with Melanoma."
10-28-13 IASLC/Sydney: “Immune Checkpoints in the Tumor Environment: Novel Targets & the Clinical Promise of Combined Immunotherapies” http://tinyurl.com/mjaweu5
…Symposium speakers: Scott J. Antonia/MD-PhD(H.Lee Moffitt CC), Dmitry I. Gabrilovich/MD-PhD(Wistar Inst), Rolf A. Brekken/PhD(UTSW), David E. Gerber/MD(UTSW)
BAVI MOA: 8-19-13 Data Supporting Bavituximab’s Immunotherapy MOA Published in “Cancer Immunology Research” (AACR) - http://tinyurl.com/mhjftka (PDF)
…“PS-Targeting Antibody Induces M1 Macrophage Polarization & Promotes Myeloid-Derived Suppressor Cell Differentiation” (Thorpe etal)
BAVI MOA: 8-13-13 PPHM/VP Dr. Jeff Hutchins’ Presentation on the Downstream Immunostimulatory Effects/Moa of PS-targeting antibodies (like Bavi) at CHI’s “Immunotherapies Congress”/Boston http://tinyurl.com/m6h2tvt
BAVI MOA: 10-12-12 NMB article on how Bavi "Induces Innate & Specific Anti-tumor Responses" http://tinyurl.com/cw9odb8
BAVI MOA: 5-1-12 Dr. Phil Thorpe's 46min talk at NYAS PS-Targeting Symposium http://tinyurl.com/9792gl5
. . .Symposium title: "Phosphatidylserine (PS) Asymmetry - Therapeutic Apps. in Cancer & Infectious Disease Symposium"
. . .Replays of 5 speakers: Alan Schroit, Chris Reutlingsperger, David Ucker, Ari Helenius, Philip Thorpe
BAVI MOA: 5-26-11 Dr.Thorpe's keynoter at Recombinant-Mabs/Barcelona http://tinyurl.com/3klpodc & http://tinyurl.com/3m33h33
= = = = = = = = = = = = = = = = Roth/J.Pantginis 12-11-14 PPHM update…
Roth Capital /Joe Pantginis - init. 7-15-10 Buy/PT=$10, CURR: Buy/$5 http://www.roth.com
. . .Universe (click link bottom right): http://roth.bluematrix.com/docs/pdf/BLUE.pdf
12-11-14/PPHM:
“F2Q15 Results; Brace Yourselves for Lots of Data Coming in 2015”
• PPHM announced F2Q15 results posting EPS of ($.07) compared to our est. of ($.08). Revenues for the qtr were $6.3mm compared to our est. of $5.6mm, and the company ended the qtr with $64.4mm in cash.
• Enrollment in the Phase III SUNRISE study is expected to be complete by YE15.
• We look forward to what is shaping up to be a data-driven 2015 with catalysts from multiple studies in hepatocellular carcinoma, NSCLC, Melanoma, and Rectal adenocarcinoma.
• Reiterate Buy, $5 target.
IMPACT:
We are encouraged by the continued progress in SUNRISE enrollment as well as by management efforts to expand bavituximab's profile. As SUNRISE continues to enroll patients at over 150 global centers, we look forward to what is shaping up to be a data-driven 2015 with catalysts from multiple ISTs in hepatocellular carcinoma, NSCLC, breast cancer, melanoma and rectal adenocarcinoma. We believe that data from the Phase Ib of bavituximab with ipilimumab in Melanoma will garner interest and increase visibility. This study, set to enroll up to 24 patients, should provide further support for combination of bavituximab with checkpoint inhibitors. We look forward to updated data from the Phase I/II IST study of bavituximab with sorafenib in Liver cancer at GI ASCO (Jan’15) and SSO (Mar’15). Recall that data from this study at SITC showed that following treatment, there was an increase in CD8+ infiltrating cells into the tumor mass as well as induction of PD1+, giving additional support for combination study with anti-PD-1 inhibitors. PPHM also expects to have addl. data from a Phase Ib IST study of bavituximab with carboplatin & pemetrexed in untreated stage IV NSCLC. A Phase I IST of bavituximab with capecitabine & radiation in Rectal adenocarcinoma is also expected to have data, expanding bavituximab's potential treatment profile. We look forward to see how PPHM follows up with the clinical development program in Breast cancer, with final data from the Phase I IST study in HER2-negative metastatic Breast cancer submitted for publication.
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 2015.
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