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10-10-16: Topline SUNRISE Data Oral Pres. at ESMO’16/Copenhagen – A ‘Proffered Paper Session’, def. “Oral presentations by authors presenting original data of superior quality, followed by expert discussion and perspectives.” LEAD author is David R. Spigel (CSO/Dir./Sarah Cannon Res. Inst., Nashville) and SENIOR author is UTSW’s Dr. David Gerber (previously presented Ph2/NSCLC data and Prelim. SUNRISE data at AACR’14). As JD found on ESMO.org, the 1st author listed is the presenting author, so it’s gonna be DR. DAVID R. SPIGEL!
From the 9-21-16 PR: “Presented data will include a biomarker in the SUNRISE trial that correlated with a statistically significant improvement in OS for patients treated with bavituximab+Doce vs. Doce alone.”
...Also, Peregrine is Exhibiting: Booth #418.
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Oct7-11 2016: “41st ESMO European Cancer Congress”, Copenhagen, Denmark
http://www.esmo.org/Conferences/ESMO-2016-Congress
ESMO = European Society for Medical Oncology, ECCO = European CanCer Organization
PPHM EXHIBITING: Booth #418 (Floorplan: http://tinyurl.com/zqhv88v )
Pgm: http://www.esmo.org/Conferences/ESMO-2016-Congress/Programme
I. 10-9-16 1:00-2:00pm: POSTERS - Topic: Immunotherapy of Cancer
#1074P: “Antibody Mediated Blockade of Phosphatidylserine Improves Immune Checkpoint Blockade by Repolarizing Immune Suppressive Mechanisms of the Tumor Microenvironment” - Jeff Hutchins(VP/PreClin.Res), Peregrine Pharmaceuticals (pg.165)
9-8-16/CC/JeffH: “Exciting new internal work on PPHM’s I-O preclin. studies (Jeff Hutchins) will be presented.”
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II. 10-10-16 Type: Proffered Paper Session* - “NSCLC/Metastatic2”
*Proffered Paper Session = Oral presentations by authors presenting original data of superior quality, followed by expert discussion and perspectives.
Chairs: Fiona Blackhall(GB); Tony S.K. Mok(Hong Kong)
10-10-16 9:15-9:30am #LBA45: “Top-line Results from SUNRISE: A Phase III, Randomized, Double-Blind, Placebo-Ctl’d Multicenter Trial of Bavituximab + Docetaxel in Patients with Previously Treated Stage IIIb/IV Non-Squamous NSCLC”
David R. Spigel###(LEAD AUTHOR: CSO/Dir. Lung Cancer Res. Pgm. at Sarah Cannon Res. Inst., Nashville) 1, I. Bondarenko 2, G. Losonczy 3, J. Mezger 4, H. Kalofonos 5, M. Reck 6, R. Palmero 7, T. Jang 8, R. Natale 9, R. Sanborn 10, J. Lai 11, N. Kallinteris 12, M. Tang 11, J. Shan 13, David E. Gerber***(SENIOR AUTHOR: UTSW/Dallas) 14
1=Nashville TN; 2=Dnepropetrovsk, UA, 3=Budapest, HU, 4=Karlsruhe, DE, 5=Patras, GR, 6=Grosshansdorf, DE, 7=Barcelona, ES, 8=Busan, KR, 9=Los Angeles CA, 10=Portland OR, 11/12/13=Tustin CA; 14=UTSW/Dallas
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###6-1-16: “Sarah Cannon Appoints David Spigel, MD to CSO… For more than 10yrs, Dr. Spigel, has been instrumental in bringing the latest targeted therapies to patients through our lung cancer research program...” - see: http://tinyurl.com/jgxhjdn . Many Dr. David Spigel interviews on lung cancer here: https://www.youtube.com/results?search_query=David+Spigel – esp. interesting, the 4th one down: “Dr. David Spigel on Fox News Discussing Novel Therapies at ASCO 2015” https://www.youtube.com/watch?v=eb2L5xRedhQ (at 1:45 he discusses the emergence of I-O therapies: “It’s a very exciting time in oncology.”)
***UTSW’s Dr. David Gerber presented Prelim. SUNRISE Data 5-31-14 at ASCO’14 – see http://tinyurl.com/nv4jloo
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BAVITUXIMAB "SUNRISE" PHASE III TRIAL: http://www.SunriseTrial.com
A. Phase III Bavi+Doce vs. 2nd-Line NSCLC "SUNRISE" (randomized, double-blind, placebo-ctl'd, n=582)
USA Protocol: http://www.clinicaltrials.gov/ct2/show/NCT01999673
...2 ARMS: A=BAVI/3mg+DOCE(Weekly), B=Doce+Placebo(Weekly)
...161 sites a/o 7-9-15 (USA/39 Aus/9 Bel/7 Fr/9 Ger/15 Greece/10 Hungary/7 Italy/10 Korea/9 Rom/6 Rus/8 Spain/16 Taiwan/10 Ukraine/6) - Growth: http://tinyurl.com/qbemrr2
2-25-16: IDMC Halts SUNRISE at 1st Look-in. Bavi+Doce arm “OS performing as expected”; Doce arm “dramatically outperforming OS expectations” http://tinyurl.com/jbg48vs
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5-31-14 ASCO’14: David Gerber/Joe Shan Poster on Ph3/SUNRISE Trial (#TPS8129) http://tinyurl.com/nv4jloo
9-21-16/PR About ESMO’16/Copenhagen:
Peregrine Pharmaceuticals Provides Update on Oral Presentation of Top-Line Data from Phase III SUNRISE Trial of Bavituximab at European Society for Medical Oncology (ESMO) 2016 Congress
“Ongoing Biomarker Analysis Has Identified a Biomarker that is Associated with a Statistically Significant Improvement in Overall Survival for Patients Receiving the Bavituximab Combination”
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=990296
TUSTIN, Sept. 21, 2016: Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM/PPHMP), a biopharmaceutical company committed to improving patient lives by manufacturing high quality products for biotechnology and pharmaceutical companies and advancing its proprietary R&D pipeline, today announced that top-line data from the Phase III SUNRISE trial of bavituximab in patients with previously treated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) will be presented as a late-breaking oral presentation at the upcoming European Society for Medical Oncology (ESMO) 2016 Congress. Presented data will include a biomarker in the SUNRISE trial that correlated with a statistically significant improvement in overall survival for patients treated with bavituximab in combination with docetaxel compared to patients treated with docetaxel alone. Peregrine will file a new patent application directed to the use of the biomarker prior to the presentation of results at the ESMO 2016 Congress, which is being held October 7-11, 2016 in Copenhagen, Denmark.
Details of the Phase III SUNRISE trial data presentation are as follows:
Presentation #LBA45
Presentation Title: “Top-line results from SUNRISE: A Phase III Randomized Double-Blind, Placebo-Controlled Multicenter Trial of Bavituximab Plus Docetaxel in Patients with Previously Treated Stage IIIb/IV Non-Squamous NSCLC”
Date: Monday, October 10, 2016 Time: 9:15am (local time in Copenhagen)
"I want to start by thanking the patients, investigators and scientists involved in the SUNRISE trial that have made possible the continuing collection and analysis of important data from the study. While the current interim analysis is still ongoing, it is exciting to already see that a biomarker associated with positive outcomes for patients receiving the combination of bavituximab with docetaxel has been identified. In the evolving cancer therapeutic space, biomarker identification is playing an increasingly critical role in guiding clinical development strategies and trial designs," said Steven W. King, President and CEO of Peregrine. "It is important to note that we are undertaking a broad biomarker analysis effort as part of the SUNRISE trial and this initial set of data is just the first of what we hope will be several findings that will help guide the bavituximab clinical program going forward. We look forward to presenting results from this ongoing analysis effort at the ESMO 2016 Congress, as well as other medical conferences as the additional data becomes available."
The primary goal of the biomarker analysis is to identify a biomarker profile for patients that receive the most benefit from a bavituximab-containing therapeutic regimen. As specified in the study protocol, thousands of patient samples were collected to potentially identify biomarkers associated with improved outcome for patients receiving bavituximab. Peregrine is in the process of filing a new patent application directed to the use of the initial biomarker discovery which will be presented at the ESMO 2016 Congress. Additional patient sample testing and analysis is ongoing and may result in other biomarkers of importance.
Bavituximab is an investigational chimeric monoclonal antibody that targets phosphatidylserine (PS). Signals from PS inhibit the ability of immune cells to recognize and fight tumors. Bavituximab is believed to override PS mediated immunosuppressive signaling by blocking the engagement of PS with its receptors as well as by sending an alternate immune activating signal. PS targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and anti-tumor immune responses.
Peregrine's clinical development strategy for bavituximab is currently focused on small, early-stage proof-of-concept trials evaluating the drug in combination with other cancer treatments. The intent behind this strategy is to control research and development costs, while continuing to generate clinical data to further validate bavituximab's combination potential that will be critical to bringing onboard a partner to help advance the program.
ABOUT PEREGRINE PHARMACEUTICALS, INC. *snip*
Safe Harbor *snip*
Contacts: Vida Strategic Partners - Stephanie Diaz (Investors) 415-675-7401 sdiaz@vidasp.com, Tim Brons (Media), 415-675-7402
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9-8-16/CC CEO Steve King: “Topline data from our Phase III SUNRISE trial have been accepted for a late-breaking oral presentation [10-10-16, Dr. David Gerber, UTSW, Lead Author – see below] at the upcoming European Society of Medical Oncology (ESMO) Congress to be held in Copenhagen in early October [Oct7-11]. ESMO is the premier European oncology meeting, attended by thousands of oncologists. The presentation at ESMO will be a great opportunity to share clinical data from the study in conjunction with initial results from ongoing biomarker analysis, which are already highly encouraging. Biomarker analysis was built into the SUNRISE trial from the beginning, including the collection of thousands of patient samples that could be analyzed once of the trial was unblinded. The primary goal the biomarker analysis is to identify a biomarker pattern, present in patients that receive the most benefit from a bavituximab containing therapeutic regimen, and we look forward to sharing the results of the ongoing analysis, with more data expected later in the year. The impact of the effective biomarker identification is already quite evident in oncology drug development, with the latest evidence being PD1/PD-L1 in the development of Keytruda. These types of biomarkers can only be identified through analysis of larger patient populations, such as in the SUNRISE trial. The results of identifying effective biomarkers can potentially have a huge impact on clinical development, potentially reducing the size of future trials, including making possible biomarker-driven clinical designs which could provide even more rapid readouts. Taken together, these developments are setting the stage for new data throughout the rest of 2016 and into 2017.” http://tinyurl.com/jmy77g3
9-8-16/CC: ROBERT GARNICK (Head of Reg. Affairs):
“I’d like to emphasize the strategic importance of the biomarker study, which, as Joe said, was built into the SUNRISE trial. The identification of a positive biomarker or relevant biomarker pattern with clinical efficacy is an important facet of clinical trial design that can be used to inform addl. new studies that in turn might be used to select patients who would best benefit from bavituximab therapy. For example, the identification of the HER2 biomarker was critical in the development of Herceptin. Its importance was only critically established based on the results of a Phase II clinical trial. As Steve previously described, the critical role of the PD-L1 biomarker is emerging as a major factor in the selection of patients for the clinical use of Opdivo & Keytruda. In the case of bavituximab, once a promising biomarker or biomarker pattern is identified, we strategically plan to include these results into potential new clinical trials. I will now turn the call over to Jeff Hutchins, VP of Preclin. Research.” http://tinyurl.com/jydtkoy
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UTSW’s Dr. David Gerber (SUNRISE ESMO’16/LeadAuthor) quoted in MOONSHOT article… Recall, Dr. Gerber is the Lead Author of the upcoming Oct. 10 ESMO’16 late-breaking Proffered Paper (Oral Presentation) of Topline data from our Phase III SUNRISE trial, including initial results from ongoing biomarker analysis, which CEO Steve King described in the 9-8-16 CC as “already highly encouraging”.
9-8-16/SciNews: “Panel Outlines Research Priorities for Cancer Moonshot”
https://www.sciencenews.org/article/panel-outlines-research-priorities-cancer-moonshot
...”Recommendations emphasize importance of data sharing, promise of immunotherapy” ...For treatment, the report singles out immunotherapy, which harnesses a patient’s own immune system to fight cancer. The strategy is widely regarded as one of the most significant advances in cancer care, even though so far only 10-20% of patients receiving such treatments show long-term benefit. “When I speak to my patients, I tell them that the greatest risk is disappointment,” says medical oncologist David Gerber of the Univ. of Texas SW Medical Center/Dallas. Nonetheless, he and others remain optimistic about immunotherapy’s potential, and he agrees with recommendations to speed up research. In proposing an immunotherapy clinical trials network, the report states that current treatments “represent only the tip of the iceberg of what is possible.”
- - - - - - - - - -Recall:
1-13-16: “JP Morgan - Jumping In Front Of The Cancer Immunotherapy Parade”
EP Vantage Newsletter Provider
Steven King, CEO of Peregrine Pharmaceuticals, sees the potential for this (Cancer MoonShot 2020) initiative to offer an opportunity for smaller companies to run more combination trials. While Peregrine is planning a trial in combination of its immuno-oncology agent bavituximab with AstraZeneca’s durvalumab and is collaborating with the National Comprehensive Cancer Network (NCCN) for other combination trials, this coalition might serve to stimulate an expansion of clinical work. “It’s often access to drugs. If you want to run a combination with Keytruda or Opdivo, you’re going to have to buy the drug,” he told EP Vantage in an interview on the sidelines of the JP Morgan meeting. “It becomes a cost issue. You’re not going to be able to run as many studies.”
MORE: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=119836127
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Sep22: Phacilitate’s "Immunotherapy Europe" (Strategic Partnering Event), Berlin http://tinyurl.com/hwxax88
...9:50-10:20am WEBINAR - CEO Steve King is Panelist w/BMS/Merck/Agenus: “Analyzing The Business & Partnering Model in Industry & Academia for the Future Dev. of I-O Combination Therapies”
Sep25-28: 2nd AACR-CRI Intl. Cancer Immunotherapy Conf.”, NYC http://tinyurl.com/hxtbdfm
...Sep26 5:15-7:45pm: Bruce Freimark(Dir.Res/Preclin.Oncology) poster B019, “LAG3 is an Immunotherapeutic Target in Murine Triple- Breast Cancers, Whose Activity is Significantly Enhanced in Combo with PS-Targeting Antibodies”
...Sep26 5:15-7:45pm: Dr. Raymond Birge(Rutgers) & PPHM poster B119, “Characterization of a PS, TAM Receptor (Tyro3, Axl, Mertk), PDL1 Axis in Breast Cancer”
Oct4-7/Avid/Booth#716: IBC's BioProcess Intl. Conf., Boston http://www.ibclifesciences.com/BPI/overview.xml & http://tinyurl.com/zyblds7
...10-5-16/8-8:30am: Peter Gagnon(Avid's VP/Process-Svcs), ”Across the Great Divide: The Upstream Origins & Downstream Ramifications of a Newly Discovered Contaminant Class”
Oct7-11: 41st ESMO European Cancer Congress, Copenhagen, Denmark http://tinyurl.com/zcsa4md (Oral Pres. of Topline Data from Ph3 SUNRISE trial, incl. initial Biomarker analysis)
...10-10-16 9:15-9:30am: David R. Spigel (CSO/Dir./Sarah Cannon Res. Inst., Nashville) Proffered Oral Presentation, “Top-line Results from Ph3/SUNRISE..." (Senior-Author: David Gerber/UTSW)
......9-21-16 PR said, "Presented data will include a biomarker in the SUNRISE trial that correlated with a statistically significant improvement in OS for patients treated with Bavi+Doce vs. Doce alone.”
...10-9-16 1:00-2:00pm: Jeff Hutchins(VP/PreClin.Res), “Antibody Mediated Blockade of PS Improves Immune Checkpoint Blockade...”
Oct13/10am: Annual SHM, Avenue of the Arts Hotel, Costa Mesa – Final Proxy: http://tinyurl.com/gsrmgs2
Nov9-13: (SITC) Society for Immunotherapy of Cancer 31st Annual Meeting”, Natl-Harbor MD http://www.sitcancer.org/2016
...”First Results” from our collaboration with Jedd Wolchok Lab investigators (MSK) to be presented” (per 9-8-16/Ccall/Hutchins)
~Dec8: FY'17Q2 (qe 10-31-16) Financials & Conf. Call - http://ir.peregrineinc.com/events.cfm
Dec11-15/Avid/Booth#209: IBC's Antibody Eng. & Therapeutics 2016”, SanDiego http://www.ibclifesciences.com/AntibodyEng/overview.xml
Feb20-22 2017: “CHI’s 5th Translational Models in Oncology & I-O”, SanFran http://www.triconference.com/Pre-Clinical-Oncology-Models
...Bruce Freimark(Dir.Res/Preclin.Oncology), ”Blockade of PS-Mediated Tumor Immune Suppression to Enhance Immune Checkpoint Therapies”
Per Springer.com, “New-Trial-Records” for the 3 upcoming NCCN/Bavi trials. All 3 dated 9-23-16 – not sure if this means they hit http://ClinicalTrials.gov in some sort of draft status – I just checked and they’re not viewable there as yet.
Phase I/II: “A Study of Bavituximab with Radiation & Temozolomide[Merck’s Temodar] for Patients with Newly Diagnosed Glioblastoma”… This phase I/II study will investigate the safety & efficacy...
http://adisinsight.springer.com/trials/700276383
[MASS-GEN. CANCER CENTER - PI: Elizabeth Gerstner, MD]
Phase II: “A Study Bavituximab & Pembrolizumab[Merck’s KEYTRUDA] for Progressive Recurrent/Metastatic Squamous Cell Carcinoma of the Head & Neck”… This phase II study will investigate the safety & efficacy...
http://adisinsight.springer.com/trials/700276389
[JOHN-HOPKINS(Sidney Kimmel CC) - PI: Ranee Mehra, MD]
Phase I: “A Study of Sorafenib[Bayer’s Nexavar] & Bavituximab + Stereotactic Body Radiation Therapy (SBRT) for Unresectable HepC Associated Hepatocellular Carcinoma”… This phase I study will investigate the safety of...
http://adisinsight.springer.com/trials/700276381
[MOFFITT CANCER CENTER - PI: Jessica Frakes, MD]
AdisInsight databases – Springer FAQ http://adisinsight.springer.com/
WHAT SOURCES ARE MONITORED?
Our scientific editors monitor thousands of sources daily including: medical journals, press releases, conference proceedings, company websites and pipelines, trial registries, and regulatory agency websites.
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9-6-16: NCCN to Initiate 3 Bavi-Trials Early’17 (Moffitt,MassGEN,JohnHopkins) http://tinyurl.com/gutgwb5
=> Ph1/HepC-Related-Hepatocellular/MOFFITT, Ph1-2/Glioblastoma/MASS-GEN, Ph2/Head+Neck/JOHN-HOPKINS
NCCN PR: https://www.nccn.org/about/news/newsinfo.aspx?NewsID=785
”NCCN is excited to initiate 3 studies by accomplished investigators at Member Institutions that will explore the effect of this novel immunotherapy in 3 different cancers with significant unmet need,” said Robert C. Young, MD, Interim VP, NCCN ORP.
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3 NCCN Bavituximab Trials Announced 9-6-16 – "Early 2017" (Moffitt, MassGEN, JohnHopkins) :
#1: Ph1/HepC-Related Hepatocellular (Bavi+RAD+Sorafenib), MOFFITT CANCER CENTER - PI: Jessica Frakes, MD
"A Phase I Trial of Sorafenib & Bavituximab + Stereotactic Body Radiation Therapy (SBRT) for Unresectable Hepatitis C Associated Hepatocellular Carcinoma"
=> 9-8-16/CC/JoeShan: “The 1st award is for a Phase I trial of Sorafenib [Bayer’s Nexavar] and bavituximab + radiation in Hepatocellular Carcinoma. This will build on a previously reported investigator sponsored Phase II trial of bavituximab & sorafenib in Liver Cancer. [3-25-15/Dr.Adam.Yopp(UTSW)/Ph2data, N=38: http://tinyurl.com/opkh5qy ]”
#2: P1-2/Newly Diag. Glioblastoma (Bavi+RAD+Merck’s Temodar), MASS-GEN. CANCER CENTER - PI: Elizabeth Gerstner, MD
"Phase I/II Clinical Trial of Bavituximab with Radiation & Temozolomide(Temodar) for Patients with Newly Diagnosed Glioblastoma"
=> 9-8-16/CC/JoeShan: “The 2nd award is for a Phase I/II trial of bavituximab with radiation + temozolomide [Merck’s Temodar] in newly diagnosed Glioblastoma. This trial is supported by some of our most impressive preclinical data demonstrating long-term survival in a lethal brain cancer model and that surviving rats were immune from tumor re-challenge.”
#3: Ph2/Progressive Squamous Head+Neck (Bavi+Merck’s Keytruda), JOHN-HOPKINS(Sidney Kimmel CC) - PI: Ranee Mehra, MD
”Phase II Study of Pembrolizumab & Bavituximab for Progressive Recurrent/Metastatic Squamous Cell Carcinoma of the Head & Neck"
=> 9-8-16/CC/JoeShan: “The 3rd award is for a Phase II study of pembrolizumab [Merck’s Keytruda, anti-PD-1] & bavituximab in Head & Neck Cancer. We are particularly excited about this project, as it will be the first clinical trial of bavituximab with a checkpoint inhibitor. In multiple previous preclin. studies, we have observed bavituximab's potential to work synergistically with PD1 inhibitors such as pembrolizumab.”
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Joe Shan 9-8-16/CC: “These 3 studies align with our overall dev. strategy and will add to our knowledge about bavituximab-focused cancer treatment combinations. While we are not directly involved with these studies, we’ll be watching the progress carefully and look forward to providing an updates on the 3 NCCN trials in the coming months.” http://tinyurl.com/jydtkoy
Steve King 9-8-16/CC: “Our collaboration with the NCCN has been an important part of our strategy for advancing the bavituximab clinical program in a cost effective way. We earlier provided NCCN with a $2mm grant to support bavituximab related clinical research with no further financial obligations, and these grant awards represent the outcome of a competitive selection process for the best proposals. These studies will evaluate novel bavituximab combinations in Glioblastoma, Head & Neck Cancer, and Hepatocellular Carcinoma including an immunotherapy combination [Bavi + Merck’s Keytruda], which is a major focus for advancing the program.”
Steve King 9-8-16/CC/Q&A: “I’m very excited about the combinations that were chosen because the Radiation combination is one that in preclinical studies, as was mentioned during the prepared remarks, has always shown a lot of promise. It’s great to be able to now see that put into a clinical setting in a couple of different clinical trials. And the I-O combinations, as Jeff mentioned during his prepared remarks, is a major focus of ours. So to see a Pembro [Keytruda] combination picked as well, we are just really excited that these were the 3 winners out of the NCCN selection process.”
Do you still think Robert Garnick is gone?
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=125079940
Robert Garnick’s 9-8-16 comments re: upcoming ESMO’16/SUNRISE/Biomarker data, to be presented 10-10-16 in a proffered late-breaking oral presentation by lead author Dr. David R. Spigel (CSO/Dir. Lung Cancer Res. Pgm. at Sarah Cannon Res. Inst., Nashville)...
9-8-16/CC: ROBERT GARNICK (Head of Reg. Affairs):
“I’d like to emphasize the strategic importance of the biomarker study, which, as Joe said, was built into the SUNRISE trial. The identification of a positive biomarker or relevant biomarker pattern with clinical efficacy is an important facet of clinical trial design that can be used to inform addl. new studies that in turn might be used to select patients who would best benefit from bavituximab therapy. For example, the identification of the HER2 biomarker was critical in the development of Herceptin. Its importance was only critically established based on the results of a Phase II clinical trial. As Steve previously described, the critical role of the PD-L1 biomarker is emerging as a major factor in the selection of patients for the clinical use of Opdivo & Keytruda. In the case of bavituximab, once a promising biomarker or biomarker pattern is identified, we strategically plan to include these results into potential new clinical trials...” http://tinyurl.com/jydtkoy
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Oct7-11 2016: “41st ESMO European Cancer Congress”, Copenhagen, Denmark
http://www.esmo.org/Conferences/ESMO-2016-Congress
ESMO = European Society for Medical Oncology, ECCO = European CanCer Organization
PPHM EXHIBITING: Booth #418 (Floorplan: http://tinyurl.com/zqhv88v )
Pgm: http://www.esmo.org/Conferences/ESMO-2016-Congress/Programme
10-10-16 Type: Proffered Paper Session* - “NSCLC/Metastatic2”
*Proffered Paper Session = Oral presentations by authors presenting original data of superior quality, followed by expert discussion and perspectives.
Chairs: Fiona Blackhall(GB); Tony S.K. Mok(Hong Kong)
10-10-16 9:15-9:30am #LBA45: “Top-line Results from SUNRISE: A Phase III, Randomized, Double-Blind, Placebo-Ctl’d Multicenter Trial of Bavituximab + Docetaxel in Patients with Previously Treated Stage IIIb/IV Non-Squamous NSCLC”
David R. Spigel###(LEAD AUTHOR: CSO/Dir. Lung Cancer Res. Pgm. at Sarah Cannon Res. Inst., Nashville) 1, I. Bondarenko 2, G. Losonczy 3, J. Mezger 4, H. Kalofonos 5, M. Reck 6, R. Palmero 7, T. Jang 8, R. Natale 9, R. Sanborn 10, J. Lai 11, N. Kallinteris 12, M. Tang 11, J. Shan 13, David E. Gerber***(SENIOR AUTHOR: UTSW/Dallas) 14
1=Nashville TN; 2=Dnepropetrovsk, UA, 3=Budapest, HU, 4=Karlsruhe, DE, 5=Patras, GR, 6=Grosshansdorf, DE, 7=Barcelona, ES, 8=Busan, KR, 9=Los Angeles CA, 10=Portland OR, 11/12/13=Tustin CA; 14=UTSW/Dallas
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###6-1-16: “Sarah Cannon Appoints David Spigel, MD to CSO… For more than 10yrs, Dr. Spigel, has been instrumental in bringing the latest targeted therapies to patients through our lung cancer research program...” - see: http://tinyurl.com/jgxhjdn . Many Dr. David Spigel interviews on lung cancer here: https://www.youtube.com/results?search_query=David+Spigel – esp. interesting, the 4th one down: “Dr. David Spigel on Fox News Discussing Novel Therapies at ASCO 2015” https://www.youtube.com/watch?v=eb2L5xRedhQ (at 1:45 he discusses the emergence of I-O therapies: “It’s a very exciting time in oncology.”)
***UTSW’s Dr. David Gerber presented Prelim. SUNRISE Data 5-31-14 at ASCO’14 – see http://tinyurl.com/nv4jloo
9-21-16/PR About ESMO’16/Copenhagen:
Peregrine Pharmaceuticals Provides Update on Oral Presentation of Top-Line Data from Phase III SUNRISE Trial of Bavituximab at European Society for Medical Oncology (ESMO) 2016 Congress
“Ongoing Biomarker Analysis Has Identified a Biomarker that is Associated with a Statistically Significant Improvement in Overall Survival for Patients Receiving the Bavituximab Combination”
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=990296
TUSTIN, Sept. 21, 2016: Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM/PPHMP), a biopharmaceutical company committed to improving patient lives by manufacturing high quality products for biotechnology and pharmaceutical companies and advancing its proprietary R&D pipeline, today announced that top-line data from the Phase III SUNRISE trial of bavituximab in patients with previously treated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) will be presented as a late-breaking oral presentation at the upcoming European Society for Medical Oncology (ESMO) 2016 Congress. Presented data will include a biomarker in the SUNRISE trial that correlated with a statistically significant improvement in overall survival for patients treated with bavituximab in combination with docetaxel compared to patients treated with docetaxel alone. Peregrine will file a new patent application directed to the use of the biomarker prior to the presentation of results at the ESMO 2016 Congress, which is being held October 7-11, 2016 in Copenhagen, Denmark.
Details of the Phase III SUNRISE trial data presentation are as follows:
Presentation #LBA45
Presentation Title: “Top-line results from SUNRISE: A Phase III Randomized Double-Blind, Placebo-Controlled Multicenter Trial of Bavituximab Plus Docetaxel in Patients with Previously Treated Stage IIIb/IV Non-Squamous NSCLC”
Date: Monday, October 10, 2016 Time: 9:15am (local time in Copenhagen)
"I want to start by thanking the patients, investigators and scientists involved in the SUNRISE trial that have made possible the continuing collection and analysis of important data from the study. While the current interim analysis is still ongoing, it is exciting to already see that a biomarker associated with positive outcomes for patients receiving the combination of bavituximab with docetaxel has been identified. In the evolving cancer therapeutic space, biomarker identification is playing an increasingly critical role in guiding clinical development strategies and trial designs," said Steven W. King, President and CEO of Peregrine. "It is important to note that we are undertaking a broad biomarker analysis effort as part of the SUNRISE trial and this initial set of data is just the first of what we hope will be several findings that will help guide the bavituximab clinical program going forward. We look forward to presenting results from this ongoing analysis effort at the ESMO 2016 Congress, as well as other medical conferences as the additional data becomes available."
The primary goal of the biomarker analysis is to identify a biomarker profile for patients that receive the most benefit from a bavituximab-containing therapeutic regimen. As specified in the study protocol, thousands of patient samples were collected to potentially identify biomarkers associated with improved outcome for patients receiving bavituximab. Peregrine is in the process of filing a new patent application directed to the use of the initial biomarker discovery which will be presented at the ESMO 2016 Congress. Additional patient sample testing and analysis is ongoing and may result in other biomarkers of importance.
Bavituximab is an investigational chimeric monoclonal antibody that targets phosphatidylserine (PS). Signals from PS inhibit the ability of immune cells to recognize and fight tumors. Bavituximab is believed to override PS mediated immunosuppressive signaling by blocking the engagement of PS with its receptors as well as by sending an alternate immune activating signal. PS targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and anti-tumor immune responses.
Peregrine's clinical development strategy for bavituximab is currently focused on small, early-stage proof-of-concept trials evaluating the drug in combination with other cancer treatments. The intent behind this strategy is to control research and development costs, while continuing to generate clinical data to further validate bavituximab's combination potential that will be critical to bringing onboard a partner to help advance the program.
ABOUT PEREGRINE PHARMACEUTICALS, INC. *snip*
Safe Harbor *snip*
Contacts: Vida Strategic Partners - Stephanie Diaz (Investors) 415-675-7401
sdiaz@vidasp.com, Tim Brons (Media), 415-675-7402
= = = = = = = = = =
9-8-16/CC/Steve King: “Topline data from our Phase III SUNRISE trial have been accepted for a late-breaking oral presentation [10-10-16, Dr. David Gerber, UTSW, Lead Author – see below] at the upcoming European Society of Medical Oncology (ESMO) Congress to be held in Copenhagen in early October [Oct7-11]. ESMO is the premier European oncology meeting, attended by thousands of oncologists. The presentation at ESMO will be a great opportunity to share clinical data from the study in conjunction with initial results from ongoing biomarker analysis, which are already highly encouraging. Biomarker analysis was built into the SUNRISE trial from the beginning, including the collection of thousands of patient samples that could be analyzed once of the trial was unblinded. The primary goal the biomarker analysis is to identify a biomarker pattern, present in patients that receive the most benefit from a bavituximab containing therapeutic regimen, and we look forward to sharing the results of the ongoing analysis, with more data expected later in the year. The impact of the effective biomarker identification is already quite evident in oncology drug development, with the latest evidence being PD1/PD-L1 in the development of Keytruda. These types of biomarkers can only be identified through analysis of larger patient populations, such as in the SUNRISE trial. The results of identifying effective biomarkers can potentially have a huge impact on clinical development, potentially reducing the size of future trials, including making possible biomarker-driven clinical designs which could provide even more rapid readouts. Taken together, these developments are setting the stage for new data throughout the rest of 2016 and into 2017.” http://tinyurl.com/jmy77g3
INTERVIEW with CEO Steve King, prior to Phacilitate’s “Immunotherapy Europe (Strategic Partnering Event)”, Sept21-22 2016, Berlin
Transcript: http://www.cgteurope.com/Content/Steven-King
Steven King - President & CEO Peregrine Pharmaceuticals
INTERVIEW
Q: So you’ve been involved with Peregrine from the 1990s, and have been CEO of the company since 2003. How do you reflect upon the progress that the immunotherapy field has made during this period?
Well, I think it’s been extremely exciting over the last few years. I liken it to when antibodies were first discovered - everyone was very excited about the potential they had with creating more targeted therapies. However, it took a long time for them to actually come into the mainstream, but now they’re a major part of the oncology field. I think immunotherapy seems like a very similar story. At the beginning, there wasn’t lot of enthusiasm and, unfortunately, a lot of failures over the years. However, with the recent approval of the multiple indications of the PD-1 inhibitors, and most other immunotherapies, I think it has come into the golden age for immunotherapies. Therefore I think it’s a very exciting time to be involved in immunotherapy. It’s been great to see how the field has evolved, not just the drugs that have progressed but also how the knowledge of the immune system and how to really utilize it to fight cancer, has come along.
Q: At ASCO, Dr Anthony Tolcher from the South Texas Accelerated Research Institute asked a provocative question: ‘Does the current proliferation of clinical trials and immunotherapy, represent a period of growth, or a worrisome bubble?’ In your opinion, do you think the immunotherapy field is in a bubble?
I think anytime there’s success in an area there tends to be a gold rush of enthusiasm in the field. From that standpoint I do think there’s certainly a big swell of activity. There are a lot of combinations in the clinic and a lot of people trying to fit in and understand what role the current, approved immunotherapies are going to take and what needs to be done to improve those. So I think the immunotherapy field is in a bubble, but I think it’s a very positive bubble, and there are a lot of opportunities to improve on the great progress we’ve made in the immunotherapy field. This progress will hopefully extend to benefit more and more patients. I think the important question for the field is how do you take the patients who aren’t getting the big benefits and get them to respond to the therapy? Above all, there is a need to create more opportunities to find these working combinations.
Q: “The big news of 2015 was Peregrine’s clinical collaboration with Astra-Zeneca in order to advance Bavituximab into a combination therapy. Do you have any advice for other biotechs looking to establish partnerships with Big Pharma, in order to advance their pipelines into the field of combination therapies?”
Yes, I think the key is to find the right scientific rationale for the combinations and create a win-win situation. For a single company, it takes a while to really understand and execute their strategy for development. However, when you put 2 companies together, it becomes more difficult. Therefore, I think it’s really about creating those win-win situations, where you’re both going to get something positive out of the relationship. This also helps to advance the knowledge of both the compounds you’re trying to combine together. We have seen a lot of progress in the immunotherapy qualities in advanced melanoma, and NSCLC. How can combination therapy bring these benefits into the larger patient population? I think this is where the scientific knowledge & medical knowledge behind why more patients aren’t responding to therapies is critical. It’s clear that in some tumor types, even within some of the indications, like melanoma and lung cancer where there’s been success, it’s becoming clear that some patients don’t have a primed immune response that you can take advantage of through immunotherapy. I think it’s identifying those combinations that activate the immune system, in the tumor microenvironments, so you can get the whole benefit of the currently approved therapies. We’re learning more and more every year, which is exciting, because it will allow us to make more rational decisions on what to combine together in order to get the maximum benefit for the patients.
Q: What criteria are Peregrine using to choose their different cancer combinations across the industry?
For us it’s all about the scientific rationale behind the combination. Our particular compound, Bavituximab, changes the tumor microenvironment and makes it a more pro-inflammatory microenvironment. We’re trying to find compounds which will extend that immune response. It is about thinking rationally, through the pathways of inhibition, and finding those right combination partners. We are looking to find compounds that can be used to build upon each other in order to get a synergistic effect rather than adding 2 compounds together and getting an additive effect.
Q: “You’re participating in Phacilitate’s Leaders Europe 2016, in September. What are you hoping to gain from the event?”
I think this looks like a very exciting event. I think it’s great that you have the leaders from the key companies, and I think that it is going to be a really great networking opportunity for Peregrine. It’s also an opportunity to learn from some of the leaders in the field and I think the panel of speakers, as well as the attendee list, looks excellent. I am really looking forward to meeting new people, to reconnect with the people we’re already working with, and to also to learn from other’s experience in the immuno-oncology field. *end*
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CEO Steve King 9-22-16 Panelist in Berlin w/BMS/Merck/Agenus at Phacilitate’s “Immunotherapy Europe (Strategic Partnering Event)”…
Sept21-22 2016: “Phacilitate’s Immunotherapy Europe (Strategic Partnering Event)” Berlin, GER
“The Perfect Combination of Strategy & Innovation - Advancing immuno-oncology business & R&D models at Europe’s inaugural strategic partnering event. Delivering combination therapy, biomarkers, imaging, pricing & reimbursement, R&D and supply chain models to ensure next-generation immuno-oncology success.”
http://www.cgteurope.com/page.cfm/action=Seminar/libID=1/libEntryID=47
**PHACILITATE is a specialist in the organization of exclusive events for leaders from the pharma & biotech communities. Our philosophy is simple - to deliver the ultimate in strategic knowledge exchange & networking through flawless, personalized service.
Brochure: http://www.cgteurope.com/files/immunotherapy_europe_final_announcement.pdf
9-22-16 9:50-10:20am Panel:
“Analyzing The Business & Partnering Model In Industry & Academia For The Future Development Of Immuno-Oncology Combination Therapies”
Panelists/Speakers:
* Donnie McGrath - VP, Head Search & Evaluation, BusDev, Bristol-Myers Squibb
* Emmett Schmidt = Exec.Dir., Clinical Research, Merck Sharp & Dohme
* Jennifer Buell VP, Development Operations, Agenus
* Steven King – Pres. & CEO, Peregrine Pharmaceuticals - http://www.cgteurope.com/page.cfm/Action=Visitor/VisitorID=139
.
Many Dr. David Spigel interviews on lung cancer here:
Monday: Rutgers’ Raymond Birge w/Peregrine co-authors, AACR-CRI/Sept26/NYC Poster. This involves Peregrine’s “preclinical I-O focused internal efforts”, which Jeff Hutchins (VP/PreClin.Res) described in the 9-8-16 CC as, “advancing well, and we have seen impressive signs of activity with new combinations of PS targeting and other treatment modalities such as checkpoint blockers, T-cell agonists and radiation.” - see Dr. Hutchin’s 9-8-16 comments below. Note that Dr. Birge is the Senior Author of B119.
Sept25-28 2016: “2nd CRI-AACR-CIMT-EATI Intl. Cancer Immunotherapy Conf.”, NYC
“The pgm will focus on “Translating Science into Survival” and feature talks from more than 60 leaders in the field covering all areas of inquiry in cancer immunology and immunotherapy.”
http://www.aacr.org/Meetings/Pages/MeetingDetail.aspx?EventItemID=101
ABSTRACTS: http://www.cancerimmunotherapyconference.org/abstracts
9-26-16 5:15-7:45pm: Poster Session B
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Track: NEW AGENTS AND THEIR MODE OF ACTION IN ANIMALS AND HUMANS
I. #B019 “LAG3 is an Immunotherapeutic Target in Murine Triple- Breast Cancers, Whose Activity is Significantly Enhanced in Combination with Phosphatidylserine Targeting Antibodies”
Michael J. Gray, Jian Gong, Jeff Hutchins, Bruce Freimark (Peregrine Pharmaceuticals, Dir.Res/Preclin.Oncology)
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Track: MECHANISTIC MERGING OF TREATMENT MODALITIES
II. #B119 “Characterization of a Phosphatidylserine, TAM Receptor (Tyro3, Axl, Mertk), PDL1 Axis in Breast Cancer”
Canan Kasikara 1, Sushil Kumar 1, Ke Geng 1, Viral Davre 1, Cyril Empig 2, Bruce Freimark 2, Michael Gray 2, Kyle Schlunegger 2, Jeff Hutchins 2, Sergei V. Kotenko 1, Raymond B. Birge 1
1=Rutgers, New Jersey Medical School, Newark, NJ
2=Peregrine Pharmaceuticals, Tustin
- - - - -
9-8-16 CC/Jeff Hutchins: “I would now like to provide an update on Peregrine's preclinical I-O focused internal efforts and our collaboration with Memorial Sloan Kettering CC. The goal of this work is to evaluate combinations of PS targeting with other checkpoint inhibitors and immune stimulatory agents for the purpose of developing new and increasingly effective anticancer treatments. These programs are advancing well and to-date, we have seen impressive signs of activity with new combinations of PS targeting and other treatment modalities such as checkpoint blockers, T-cell agonists and radiation. These new combinations are improving overall survival accompanied with increases in cyto-reactive T cells into the tumor tissue. This exciting new internal work will be presented at the CRI/AACR Immunotherapy Meeting in NY later this month and at ESMO in early October. We expect the first results from our collaboration with the Wolchok Lab investigators to be presented at SITC in November and we will provide more detailed information as that presentation becomes available.” http://tinyurl.com/jydtkoy
= = = = = = =
2-2016: Rutgers' Dr. Raymond Birge's relationship with Peregrine & UTSW's Dr. Rolf Brekken and his 2-26-16 article, “Phosphatidylserine is a Global Immunosuppressive Signal in Efferocytosis, Infectious Disease, and Cancer” http://tinyurl.com/z5d9qt9 poster B019, “LAG3 is an Immunotherapeutic Target in Murine Triple- Breast Cancers, Whose Activity is Significantly Enhanced in Combo with PS-Targeting Antibodies”
11-9-15 SITC'15: New Bavi+Checkpoint Inhibitors preclin. data (UTSW/DUKE's Herbert K. Lyerly) http://tinyurl.com/pbof95w
...Also, collab. with Dr. Bernard Fox (Immunotherapist/Earle A. Chiles Res.Inst.) on new Immuno-Profiling Clinical Test (Opal 6-plex quantitative IF Assay), PPHM roundtable with Raymond Birge (Rutgers), Douglas Graham (Emory), Dmitry Gabrilovich (Wistar), Rolf Brekken (UTSW), Maria Karasarides (AstraZeneca) - ”Combining Bavi w/anti-PD-1 significantly enhanced O/S… significant incr. CD45+, CD8+ and CD3+ T-cells… led a prolonged anti-tumor immune response which protected the animals against a re-challenge w/same tumor.”
= = = = = = = =DR. BIRGE:
...Dr. Raymond Birge has authored ~85 scientific publications in molecular & cancer biology. http://www.ncbi.nlm.nih.gov/pubmed/?term=birge+rb
“The Birge laboratory conducts basic science focused on the eradication of cancer.”
http://birgelab.org => http://birgelab.org/biography.html
10-10-16: Topline SUNRISE Data Oral Pres. at ESMO’16/Copenhagen – A ‘Proffered Paper Session’, def. “Oral presentations by authors presenting original data of superior quality, followed by expert discussion and perspectives.” LEAD author is David R. Spigel (CSO/Dir./Sarah Cannon Res. Inst., Nashville) and SENIOR author is UTSW’s Dr. David Gerber (previously presented Ph2/NSCLC data and Prelim. SUNRISE data at AACR’14). As JD found on ESMO.org, the 1st author listed is the presenting author, so it’s gonna be DR. DAVID R. SPIGEL!
From the 9-21-16 PR: “Presented data will include a biomarker in the SUNRISE trial that correlated with a statistically significant improvement in OS for patients treated with bavituximab+Doce vs. Doce alone.”
...Also, Peregrine is Exhibiting: Booth #418.
Oct7-11 2016: “41st ESMO European Cancer Congress”, Copenhagen, Denmark
http://www.esmo.org/Conferences/ESMO-2016-Congress
ESMO = European Society for Medical Oncology, ECCO = European CanCer Organization
PPHM EXHIBITING: Booth #418 (Floorplan: http://tinyurl.com/zqhv88v )
Pgm: http://www.esmo.org/Conferences/ESMO-2016-Congress/Programme
I. 10-9-16 1:00-2:00pm: POSTERS - Topic: Immunotherapy of Cancer
#1074P: “Antibody Mediated Blockade of Phosphatidylserine Improves Immune Checkpoint Blockade by Repolarizing Immune Suppressive Mechanisms of the Tumor Microenvironment” - Jeff Hutchins(VP/PreClin.Res), Peregrine Pharmaceuticals (pg.165)
9-8-16/CC/JeffH: “Exciting new internal work on PPHM’s I-O preclin. studies (Jeff Hutchins) will be presented.”
- - - - - - - - -
II. 10-10-16 Type: Proffered Paper Session* - “NSCLC/Metastatic2”
*Proffered Paper Session = Oral presentations by authors presenting original data of superior quality, followed by expert discussion and perspectives.
Chairs: Fiona Blackhall(GB); Tony S.K. Mok(Hong Kong)
10-10-16 9:15-9:30am #LBA45: “Top-line Results from SUNRISE: A Phase III, Randomized, Double-Blind, Placebo-Ctl’d Multicenter Trial of Bavituximab + Docetaxel in Patients with Previously Treated Stage IIIb/IV Non-Squamous NSCLC”
David R. Spigel###(LEAD AUTHOR: CSO/Dir. Lung Cancer Res. Pgm. at Sarah Cannon Res. Inst., Nashville) 1, I. Bondarenko 2, G. Losonczy 3, J. Mezger 4, H. Kalofonos 5, M. Reck 6, R. Palmero 7, T. Jang 8, R. Natale 9, R. Sanborn 10, J. Lai 11, N. Kallinteris 12, M. Tang 11, J. Shan 13, David E. Gerber***(SENIOR AUTHOR: UTSW/Dallas) 14
1=Nashville TN; 2=Dnepropetrovsk, UA, 3=Budapest, HU, 4=Karlsruhe, DE, 5=Patras, GR, 6=Grosshansdorf, DE, 7=Barcelona, ES, 8=Busan, KR, 9=Los Angeles CA, 10=Portland OR, 11/12/13=Tustin CA; 14=UTSW/Dallas
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###6-1-16: “Sarah Cannon Appoints David Spigel, MD to CSO… For more than 10yrs, Dr. Spigel, has been instrumental in bringing the latest targeted therapies to patients through our lung cancer research program...” - see: http://tinyurl.com/jgxhjdn
***UTSW’s Dr. David Gerber presented Prelim. SUNRISE Data 5-31-14 at ASCO’14 – see http://tinyurl.com/nv4jloo
= = = = = = = = = = = = =
BAVITUXIMAB "SUNRISE" PHASE III TRIAL: http://www.SunriseTrial.com
A. Phase III Bavi+Doce vs. 2nd-Line NSCLC "SUNRISE" (randomized, double-blind, placebo-ctl'd, n=582)
USA Protocol: http://www.clinicaltrials.gov/ct2/show/NCT01999673
...2 ARMS: A=BAVI/3mg+DOCE(Weekly), B=Doce+Placebo(Weekly)
...161 sites a/o 7-9-15 (USA/39 Aus/9 Bel/7 Fr/9 Ger/15 Greece/10 Hungary/7 Italy/10 Korea/9 Rom/6 Rus/8 Spain/16 Taiwan/10 Ukraine/6) - Growth: http://tinyurl.com/qbemrr2
2-25-16: IDMC Halts SUNRISE at 1st Look-in. Bavi+Doce arm “OS performing as expected”; Doce arm “dramatically outperforming OS expectations” http://tinyurl.com/jbg48vs
- - - - - - -
5-31-14 ASCO’14: David Gerber/Joe Shan Poster on Ph3/SUNRISE Trial (#TPS8129) http://tinyurl.com/nv4jloo
9-21-16/PR About ESMO’16/Copenhagen:
Peregrine Pharmaceuticals Provides Update on Oral Presentation of Top-Line Data from Phase III SUNRISE Trial of Bavituximab at European Society for Medical Oncology (ESMO) 2016 Congress
“Ongoing Biomarker Analysis Has Identified a Biomarker that is Associated with a Statistically Significant Improvement in Overall Survival for Patients Receiving the Bavituximab Combination”
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=990296
TUSTIN, Sept. 21, 2016: Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM/PPHMP), a biopharmaceutical company committed to improving patient lives by manufacturing high quality products for biotechnology and pharmaceutical companies and advancing its proprietary R&D pipeline, today announced that top-line data from the Phase III SUNRISE trial of bavituximab in patients with previously treated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) will be presented as a late-breaking oral presentation at the upcoming European Society for Medical Oncology (ESMO) 2016 Congress. Presented data will include a biomarker in the SUNRISE trial that correlated with a statistically significant improvement in overall survival for patients treated with bavituximab in combination with docetaxel compared to patients treated with docetaxel alone. Peregrine will file a new patent application directed to the use of the biomarker prior to the presentation of results at the ESMO 2016 Congress, which is being held October 7-11, 2016 in Copenhagen, Denmark.
Details of the Phase III SUNRISE trial data presentation are as follows:
Presentation #LBA45
Presentation Title: “Top-line results from SUNRISE: A Phase III Randomized Double-Blind, Placebo-Controlled Multicenter Trial of Bavituximab Plus Docetaxel in Patients with Previously Treated Stage IIIb/IV Non-Squamous NSCLC”
Date: Monday, October 10, 2016 Time: 9:15am (local time in Copenhagen)
"I want to start by thanking the patients, investigators and scientists involved in the SUNRISE trial that have made possible the continuing collection and analysis of important data from the study. While the current interim analysis is still ongoing, it is exciting to already see that a biomarker associated with positive outcomes for patients receiving the combination of bavituximab with docetaxel has been identified. In the evolving cancer therapeutic space, biomarker identification is playing an increasingly critical role in guiding clinical development strategies and trial designs," said Steven W. King, President and CEO of Peregrine. "It is important to note that we are undertaking a broad biomarker analysis effort as part of the SUNRISE trial and this initial set of data is just the first of what we hope will be several findings that will help guide the bavituximab clinical program going forward. We look forward to presenting results from this ongoing analysis effort at the ESMO 2016 Congress, as well as other medical conferences as the additional data becomes available."
The primary goal of the biomarker analysis is to identify a biomarker profile for patients that receive the most benefit from a bavituximab-containing therapeutic regimen. As specified in the study protocol, thousands of patient samples were collected to potentially identify biomarkers associated with improved outcome for patients receiving bavituximab. Peregrine is in the process of filing a new patent application directed to the use of the initial biomarker discovery which will be presented at the ESMO 2016 Congress. Additional patient sample testing and analysis is ongoing and may result in other biomarkers of importance.
Bavituximab is an investigational chimeric monoclonal antibody that targets phosphatidylserine (PS). Signals from PS inhibit the ability of immune cells to recognize and fight tumors. Bavituximab is believed to override PS mediated immunosuppressive signaling by blocking the engagement of PS with its receptors as well as by sending an alternate immune activating signal. PS targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and anti-tumor immune responses.
Peregrine's clinical development strategy for bavituximab is currently focused on small, early-stage proof-of-concept trials evaluating the drug in combination with other cancer treatments. The intent behind this strategy is to control research and development costs, while continuing to generate clinical data to further validate bavituximab's combination potential that will be critical to bringing onboard a partner to help advance the program.
ABOUT PEREGRINE PHARMACEUTICALS, INC. *snip*
Safe Harbor *snip*
Contacts: Vida Strategic Partners - Stephanie Diaz (Investors) 415-675-7401
sdiaz@vidasp.com, Tim Brons (Media), 415-675-7402
= = = = = = = = = =
9-8-16/CC/Steve King: “Topline data from our Phase III SUNRISE trial have been accepted for a late-breaking oral presentation [10-10-16, Dr. David Gerber, UTSW, Lead Author – see below] at the upcoming European Society of Medical Oncology (ESMO) Congress to be held in Copenhagen in early October [Oct7-11]. ESMO is the premier European oncology meeting, attended by thousands of oncologists. The presentation at ESMO will be a great opportunity to share clinical data from the study in conjunction with initial results from ongoing biomarker analysis, which are already highly encouraging. Biomarker analysis was built into the SUNRISE trial from the beginning, including the collection of thousands of patient samples that could be analyzed once of the trial was unblinded. The primary goal the biomarker analysis is to identify a biomarker pattern, present in patients that receive the most benefit from a bavituximab containing therapeutic regimen, and we look forward to sharing the results of the ongoing analysis, with more data expected later in the year. The impact of the effective biomarker identification is already quite evident in oncology drug development, with the latest evidence being PD1/PD-L1 in the development of Keytruda. These types of biomarkers can only be identified through analysis of larger patient populations, such as in the SUNRISE trial. The results of identifying effective biomarkers can potentially have a huge impact on clinical development, potentially reducing the size of future trials, including making possible biomarker-driven clinical designs which could provide even more rapid readouts. Taken together, these developments are setting the stage for new data throughout the rest of 2016 and into 2017.” http://tinyurl.com/jmy77g3
= = = = =
UTSW’s Dr. David Gerber (SUNRISE ESMO’16/LeadAuthor) quoted in MOONSHOT article… Recall, Dr. Gerber is the Lead Author of the upcoming Oct. 10 ESMO’16 late-breaking Proffered Paper (Oral Presentation) of Topline data from our Phase III SUNRISE trial, including initial results from ongoing biomarker analysis, which CEO Steve King described in the 9-8-16 CC as “already highly encouraging”.
9-8-16/SciNews: “Panel Outlines Research Priorities for Cancer Moonshot”
https://www.sciencenews.org/article/panel-outlines-research-priorities-cancer-moonshot
...”Recommendations emphasize importance of data sharing, promise of immunotherapy” ...For treatment, the report singles out immunotherapy, which harnesses a patient’s own immune system to fight cancer. The strategy is widely regarded as one of the most significant advances in cancer care, even though so far only 10-20% of patients receiving such treatments show long-term benefit. “When I speak to my patients, I tell them that the greatest risk is disappointment,” says medical oncologist David Gerber of the Univ. of Texas SW Medical Center/Dallas. Nonetheless, he and others remain optimistic about immunotherapy’s potential, and he agrees with recommendations to speed up research. In proposing an immunotherapy clinical trials network, the report states that current treatments “represent only the tip of the iceberg of what is possible.”
- - - - - - - - - -Recall:
1-13-16: “JP Morgan - Jumping In Front Of The Cancer Immunotherapy Parade”
EP Vantage Newsletter Provider
Steven King, CEO of Peregrine Pharmaceuticals, sees the potential for this (Cancer MoonShot 2020) initiative to offer an opportunity for smaller companies to run more combination trials. While Peregrine is planning a trial in combination of its immuno-oncology agent bavituximab with AstraZeneca’s durvalumab and is collaborating with the National Comprehensive Cancer Network (NCCN) for other combination trials, this coalition might serve to stimulate an expansion of clinical work. “It’s often access to drugs. If you want to run a combination with Keytruda or Opdivo, you’re going to have to buy the drug,” he told EP Vantage in an interview on the sidelines of the JP Morgan meeting. “It becomes a cost issue. You’re not going to be able to run as many studies.”
MORE: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=119836127
= = = = = = = = = = =KNOWN UPCOMING:
Sep22: Phacilitate’s "Immunotherapy Europe" (Strategic Partnering Event), Berlin http://tinyurl.com/hwxax88
...9:50-10:20am WEBINAR - CEO Steve King is Panelist w/BMS/Merck/Agenus: “Analyzing The Business & Partnering Model in Industry & Academia for the Future Dev. of I-O Combination Therapies”
Sep25-28: 2nd AACR-CRI Intl. Cancer Immunotherapy Conf.”, NYC http://tinyurl.com/hj3ar5q
...Sep26 5:15-7:45pm: Bruce Freimark(Dir.Res/Preclin.Oncology) poster B019, “LAG3 is an Immunotherapeutic Target in Murine Triple- Breast Cancers, Whose Activity is Significantly Enhanced in Combo with PS-Targeting Antibodies”
...Sep26 5:15-7:45pm: Dr. Raymond Birge**(Rutgers) & PPHM poster B119, ”Characterization of a PS, TAM Receptor (Tyro3, Axl, Mertk), PDL1 Axis in Breast Cancer”
**Dr. Raymond Birge has authored ~85 scientific publications in molecular & cancer biology. “The Birge laboratory conducts basic science focused on the eradication of cancer.” http://birgelab.org
Oct4-7/Avid/Booth#716: IBC's BioProcess Intl. Conf., Boston http://www.ibclifesciences.com/BPI/overview.xml & http://tinyurl.com/zyblds7
...10-5-16/8-8:30am: Peter Gagnon(Avid's VP/Process-Svcs), ”Across the Great Divide: The Upstream Origins & Downstream Ramifications of a Newly Discovered Contaminant Class”
Oct7-11: 41st ESMO European Cancer Congress, Copenhagen, Denmark http://tinyurl.com/jxdppyo (Oral Pres. of Topline Data from Ph3 SUNRISE trial, incl. initial Biomarker analysis)
...10-10-16 9:15-9:30am: David R. Spigel (CSO/Dir./Sarah Cannon Res. Inst., Nashville) Proffered Oral Presentation, “Top-line Results from Ph3/SUNRISE..." (Senior-Author: David Gerber/UTSW)
......9-21-16 PR said, "Presented data will include a biomarker in the SUNRISE trial that correlated with a statistically significant improvement in OS for patients treated with Bavi+Doce vs. Doce alone.”
...10-9-16 1:00-2:00pm: Jeff Hutchins(VP/PreClin.Res), “Antibody Mediated Blockade of PS Improves Immune Checkpoint Blockade...”
Oct13/10am: Annual SHM, Avenue of the Arts Hotel, Costa Mesa – Final Proxy: http://tinyurl.com/gsrmgs2
Nov9-13: (SITC) Society for Immunotherapy of Cancer 31st Annual Meeting”, Natl-Harbor MD http://www.sitcancer.org/2016
...”First Results” from our collaboration with Jedd Wolchok Lab investigators (MSK) to be presented” (per 9-8-16/Ccall/Hutchins)
~Dec8: FY'17Q2 (qe 10-31-16) Financials & Conf. Call - http://ir.peregrineinc.com/events.cfm
Dec11-15/Avid/Booth#209: IBC's Antibody Eng. & Therapeutics 2016”, SanDiego http://www.ibclifesciences.com/AntibodyEng/overview.xml
Feb20-22 2017: “CHI’s 5th Translational Models in Oncology & I-O”, SanFran http://www.triconference.com/Pre-Clinical-Oncology-Models
...Bruce Freimark(Dir.Res/Preclin.Oncology), ”Blockade of PS-Mediated Tumor Immune Suppression to Enhance Immune Checkpoint Therapies”
CEO Steve King Tomorrow/9-22-16 Panelist in Berlin w/BMS/Merck/Agenus at Phacilitate’s “Immunotherapy Europe (Strategic Partnering Event)”. At 1st I thought it was a webinar, but the Webinar/Signup button only shows a 9-2-16 webcast on Immunotherapy.
Sept21-22 2016: “Phacilitate’s Immunotherapy Europe (Strategic Partnering Event)” Berlin, GER
“The Perfect Combination of Strategy & Innovation - Advancing immuno-oncology business & R&D models at Europe’s inaugural strategic partnering event. Delivering combination therapy, biomarkers, imaging, pricing & reimbursement, R&D and supply chain models to ensure next-generation immuno-oncology success.”
http://www.cgteurope.com/page.cfm/action=Seminar/libID=1/libEntryID=47
**PHACILITATE is a specialist in the organization of exclusive events for leaders from the pharma & biotech communities. Our philosophy is simple - to deliver the ultimate in strategic knowledge exchange & networking through flawless, personalized service.
Brochure: http://www.cgteurope.com/files/immunotherapy_europe_final_announcement.pdf
9-22-16 9:50-10:20am Panel:
“Analyzing The Business & Partnering Model In Industry & Academia For The Future Development Of Immuno-Oncology Combination Therapies”
Panelists/Speakers:
* Donnie McGrath - VP, Head Search & Evaluation, BusDev, Bristol-Myers Squibb
* Emmett Schmidt = Exec.Dir., Clinical Research, Merck Sharp & Dohme
* Jennifer Buell VP, Development Operations, Agenus
* Steven King – Pres. & CEO, Peregrine Pharmaceuticals - http://www.cgteurope.com/page.cfm/Action=Visitor/VisitorID=139
.
= = = = = = = = = = =KNOWN UPCOMING (updated):
Sep22: Phacilitate’s "Immunotherapy Europe" (Strategic Partnering Event), Berlin http://tinyurl.com/hwxax88
...9:50-10:20am WEBINAR - CEO Steve King is Panelist w/BMS/Merck/Agenus: “Analyzing The Business & Partnering Model in Industry & Academia for the Future Dev. of I-O Combination Therapies”
Sep25-28: 2nd AACR-CRI Intl. Cancer Immunotherapy Conf.”, NYC http://tinyurl.com/hj3ar5q
...Sep26 5:15-7:45pm: Bruce Freimark(Dir.Res/Preclin.Oncology) poster B019, “LAG3 is an Immunotherapeutic Target in Murine Triple- Breast Cancers, Whose Activity is Significantly Enhanced in Combo with PS-Targeting Antibodies”
...Sep26 5:15-7:45pm: Dr. Raymond Birge**(Rutgers) & PPHM poster B119, ”Characterization of a PS, TAM Receptor (Tyro3, Axl, Mertk), PDL1 Axis in Breast Cancer”
**Dr. Raymond Birge has authored ~85 scientific publications in molecular & cancer biology. “The Birge laboratory conducts basic science focused on the eradication of cancer.” http://birgelab.org
Oct4-7/Avid/Booth#716: IBC's BioProcess Intl. Conf., Boston http://www.ibclifesciences.com/BPI/overview.xml & http://tinyurl.com/zyblds7
...10-5-16/8-8:30am: Peter Gagnon(Avid's VP/Process-Svcs), ”Across the Great Divide: The Upstream Origins & Downstream Ramifications of a Newly Discovered Contaminant Class”
Oct7-11: 41st ESMO European Cancer Congress, Copenhagen, Denmark http://tinyurl.com/j7ud5an (Oral Pres. of Topline Data from Ph3 SUNRISE trial, incl. initial Biomarker analysis)
...10-10-16 9:15-9:30am: David R. Spigel (CSO/Dir./Sarah Cannon Res. Inst., Nashville) Proffered Oral Presentation, “Top-line Results from Ph3/SUNRISE..." (Senior-Author: David Gerber/UTSW)
......9-21-16 PR said, "Presented data will include a biomarker in the SUNRISE trial that correlated with a statistically significant improvement in OS for patients treated with Bavi+Doce vs. Doce alone.”
...10-9-16 1:00-2:00pm: Jeff Hutchins(VP/PreClin.Res), “Antibody Mediated Blockade of PS Improves Immune Checkpoint Blockade...”
Oct13/10am: Annual SHM, Avenue of the Arts Hotel, Costa Mesa – Final Proxy: http://tinyurl.com/gsrmgs2
Nov9-13: (SITC) Society for Immunotherapy of Cancer 31st Annual Meeting”, Natl-Harbor MD http://www.sitcancer.org/2016
...”First Results” from our collaboration with Jedd Wolchok Lab investigators (MSK) to be presented” (per 9-8-16/Ccall/Hutchins)
~Dec8: FY'17Q2 (qe 10-31-16) Financials & Conf. Call - http://ir.peregrineinc.com/events.cfm
Dec11-15/Avid/Booth#209: IBC's Antibody Eng. & Therapeutics 2016”, SanDiego http://www.ibclifesciences.com/AntibodyEng/overview.xml
Feb20-22 2017: “CHI’s 5th Translational Models in Oncology & I-O”, SanFran http://www.triconference.com/Pre-Clinical-Oncology-Models
...Bruce Freimark(Dir.Res/Preclin.Oncology), ”Blockade of PS-Mediated Tumor Immune Suppression to Enhance Immune Checkpoint Therapies”
CEO Steve King THUR/9-22-16 Panelist in Berlin w/BMS/Merck/Agenus at Phacilitate’s “Immunotherapy Europe (Strategic Partnering Event)”…
Sept21-22 2016: “Phacilitate’s Immunotherapy Europe (Strategic Partnering Event)” Berlin, GER
“The Perfect Combination of Strategy & Innovation - Advancing immuno-oncology business & R&D models at Europe’s inaugural strategic partnering event. Delivering combination therapy, biomarkers, imaging, pricing & reimbursement, R&D and supply chain models to ensure next-generation immuno-oncology success.”
http://www.cgteurope.com/page.cfm/action=Seminar/libID=1/libEntryID=47
**PHACILITATE is a specialist in the organization of exclusive events for leaders from the pharma & biotech communities. Our philosophy is simple - to deliver the ultimate in strategic knowledge exchange & networking through flawless, personalized service.
Brochure: http://www.cgteurope.com/files/immunotherapy_europe_final_announcement.pdf
9-22-16 9:50-10:20am Panel:
“Analyzing The Business & Partnering Model In Industry & Academia For The Future Development Of Immuno-Oncology Combination Therapies”
Panelists/Speakers:
* Donnie McGrath - VP, Head Search & Evaluation, BusDev, Bristol-Myers Squibb
* Emmett Schmidt = Exec.Dir., Clinical Research, Merck Sharp & Dohme
* Jennifer Buell VP, Development Operations, Agenus
* Steven King – Pres. & CEO, Peregrine Pharmaceuticals - http://www.cgteurope.com/page.cfm/Action=Visitor/VisitorID=139
.
.
.
= = = = = = = = = = =KNOWN UPCOMING:
Sep22: Phacilitate’s "Immunotherapy Europe" (Strategic Partnering Event), Berlin http://tinyurl.com/hwxax88
...9:50-10:20am WEBINAR - CEO Steve King is Panelist w/BMS/Merck/Agenus: “Analyzing The Business & Partnering Model in Industry & Academia for the Future Dev. of I-O Combination Therapies”
Sep25-28: 2nd AACR-CRI Intl. Cancer Immunotherapy Conf.”, NYC http://tinyurl.com/hj3ar5q
...Sep26 5:15-7:45pm: Bruce Freimark(Dir.Res/Preclin.Oncology) poster B019, “LAG3 is an Immunotherapeutic Target in Murine Triple- Breast Cancers, Whose Activity is Significantly Enhanced in Combo with PS-Targeting Antibodies”
...Sep26 5:15-7:45pm: Dr. Raymond Birge**(Rutgers) & PPHM poster B119, ”Characterization of a PS, TAM Receptor (Tyro3, Axl, Mertk), PDL1 Axis in Breast Cancer”
**Dr. Raymond Birge has authored ~85 scientific publications in molecular & cancer biology. “The Birge laboratory conducts basic science focused on the eradication of cancer.” http://birgelab.org
Oct4-7/Avid/Booth#716: IBC's BioProcess Intl. Conf., Boston http://www.ibclifesciences.com/BPI/overview.xml & http://tinyurl.com/zyblds7
...10-5-16/8-8:30am: Peter Gagnon(Avid's VP/Process-Svcs), ”Across the Great Divide: The Upstream Origins & Downstream Ramifications of a Newly Discovered Contaminant Class”
Oct7-11: 41th ESMO European Cancer Congress, Copenhagen, Denmark http://tinyurl.com/hslo2lq (Oral Pres. of Topline Data from the Ph3 SUNRISE trial)
...10-10-16 9:15-9:30am: Dr. David R. Spigel(LEAD, CSO/Dir./Sarah Cannon Res. Inst.) or Dr. David Gerber(SENIOR Author, UTSW) Proffered Oral Presentation, “Top-line Results from Ph3/SUNRISE..." (incl. “initial results from ongoing biomarker analysis”)
...10-9-16 1:00-2:00pm: Jeff Hutchins(VP/PreClin.Res), “Antibody Mediated Blockade of PS Improves Immune Checkpoint Blockade...”
Oct13/10am: Annual SHM, Avenue of the Arts Hotel, Costa Mesa – Final Proxy: http://tinyurl.com/gsrmgs2
Nov9-13: (SITC) Society for Immunotherapy of Cancer 31st Annual Meeting”, Natl-Harbor MD http://www.sitcancer.org/2016
...”First Results” from our collaboration with Jedd Wolchok Lab investigators (MSK) to be presented” (per 9-8-16/Ccall/Hutchins)
~Dec8: FY'17Q2 (qe 10-31-16) Financials & Conf. Call - http://ir.peregrineinc.com/events.cfm
Dec11-15/Avid/Booth#209: IBC's Antibody Eng. & Therapeutics 2016”, SanDiego http://www.ibclifesciences.com/AntibodyEng/overview.xml
Feb20-22 2017: “CHI’s 5th Translational Models in Oncology & I-O”, SanFran http://www.triconference.com/Pre-Clinical-Oncology-Models
...Bruce Freimark(Dir.Res/Preclin.Oncology), ”Blockade of PS-Mediated Tumor Immune Suppression to Enhance Immune Checkpoint Therapies”
TTradr, out of my league, but I'll GUESS: I think that these current "Proc. Validation Runs" produce sellable product (note PL's 9-8-16 CC statement, "multiple process validation runs and those runs right now are built into our financial projections of the $50-55mm
"), even though that last FDA approval step ("you can produce for Commercial Supply") hasn't occurred. Such product goes into Inventory at cost, and when it is (tested?)/shipped, revs are produced and the Inventory cost is transferred to COGS.
Myford(Avid II) currently doing “multiple process validation runs” - the final FDA step before commercial runs.
PAUL LYTLE(9-8-16 CC Q&A): “We recognized $44mm in revenues last FY (fye 4-30-16) and that all came from our original Franklin facility. In March this year, we commissioned our new Myford facility, which is built for late stage Phase III clinical & commercial production. We are currently going through the motions of multiple process validation runs and those runs right now are built into our financial projections of the $50-55mm, with our goal of turning those process validation runs, which is the final step before submitting something to the FDA under preapproval inspection in terms of producing commercial quantities for those clients. So, this year is really a building year in terms of building those process validation runs for our clients, and then we’re hopeful that those will turn into commercial supply needs in future FY’s.”
http://edge.media-server.com/m/p/vdqbf8gx
Lisa Stepp(PhD,PPHM Sen.Dir/MedicalAffairs) today, then EVENTS Heat UP
Sept14-16 2016: “EXL's 11th Medical Affairs Executive Forum”, SanDiego
http://exlevents.com/medical-affairs-executive-forum-west
“The role of medical affairs teams in the life science industry has seen an expansion of functionality & responsibility, especially with easier access to information through digital platforms. A primary focus for medical affairs leadership is to ensure the compliant separation of clinical & commercial teams, particularly regarding their access to therapeutic area experts. Communication channel mgt. will serve as one of the driving themes for the Medical Affairs Strategic Summit (MASS) West 2016...”
9-15-16 11:15–12pm: “The Effects of Company Size on the Establishment of an Advisory Board Benchmark” - Lisa Stepp, PhD, Sen.Dir./Medical Affairs, Peregrine Pharmaceuticals
- - - -
Lisa Stepp (PhD/MBA) joined Peregrine 3-2015 as “Sr. Dir./Medical Affairs” - formerly with Gilead, Allos, Genentech, and Wyeth.
https://www.linkedin.com/in/lisa-stepp-phd-mba-345942a
= = = = = = = = = = = = = = = = =KNOWN UPCOMING:
Sep15: EXL's 11th Medical Affairs Executive Forum, SanDiego http://exlevents.com/medical-affairs-executive-forum-west
...11:15–12pm: Dr. Lisa Stepp, PPHM's PhD/Sen.Dir./MedAffairs, “<uiEffects of Co. Size on the Est. of an Advisory Board Benchmark”
Sep22: Phacilitate’s "Immunotherapy Europe" (Strategic Partnering Event), Berlin http://tinyurl.com/hwxax88
...9:50-10:20am WEBINAR - CEO Steve King is Panelist w/BMS/Merck/Agenus: “Analyzing The Business & Partnering Model in Industry & Academia for the Future Dev. of I-O Combination Therapies”
Sep25-28: 2nd AACR-CRI Intl. Cancer Immunotherapy Conf.”, NYC http://tinyurl.com/hj3ar5q
...Sep26 5:15-7:45pm: Bruce Freimark(Dir.Res/Preclin.Oncology) poster B019, “LAG3 is an Immunotherapeutic Target in Murine Triple- Breast Cancers, Whose Activity is Significantly Enhanced in Combo with PS-Targeting Antibodies”
...Sep26 5:15-7:45pm: Dr. Raymond Birge**(Rutgers) & PPHM poster B119, ”Characterization of a PS, TAM Receptor (Tyro3, Axl, Mertk), PDL1 Axis in Breast Cancer”
**Dr. Raymond Birge has authored ~85 scientific publications in molecular & cancer biology. “The Birge laboratory conducts basic science focused on the eradication of cancer.” http://birgelab.org
Oct4-7/Avid/Booth#716: IBC's BioProcess Intl. Conf., Boston http://www.ibclifesciences.com/BPI/overview.xml & http://tinyurl.com/zyblds7
...10-5-16/8-8:30am: Peter Gagnon(Avid's VP/Process-Svcs), ”Across the Great Divide: The Upstream Origins & Downstream Ramifications of a Newly Discovered Contaminant Class”
Oct7-11: 41th ESMO European Cancer Congress, Copenhagen, Denmark http://tinyurl.com/j2cng2y (Oral Pres. of Topline Data from the Ph3 SUNRISE trial)
...10-10-16 9:15-9:30am: Dr. David Gerber(UTSW) Proffered Oral Presentation, “Top-line Results from Ph3/SUNRISE..." (incl. “initial results from ongoing biomarker analysis”)
...10-9-16 1:00-2:00pm: Jeff Hutchins(VP/PreClin.Res), “Antibody Mediated Blockade of PS Improves Immune Checkpoint Blockade...”
Oct13/10am: Annual SHM, Avenue of the Arts Hotel, Costa Mesa – Final Proxy: http://tinyurl.com/gsrmgs2
Nov9-13: (SITC) Society for Immunotherapy of Cancer 31st Annual Meeting”, Natl-Harbor MD http://www.sitcancer.org/2016
...”First Results” from our collaboration with Jedd Wolchok Lab investigators (MSK) to be presented” (per 9-8-16/Ccall/Hutchins)
~Dec8: FY'17Q2 (qe 10-31-16) Financials & Conf. Call - http://ir.peregrineinc.com/events.cfm
Dec11-15/Avid/Booth#209: IBC's Antibody Eng. & Therapeutics 2016”, SanDiego http://www.ibclifesciences.com/AntibodyEng/overview.xml
Feb20-22 2017: “CHI’s 5th Translational Models in Oncology & I-O”, SanFran http://www.triconference.com/Pre-Clinical-Oncology-Models
...Bruce Freimark(Dir.Res/Preclin.Oncology), ”Blockade of PS-Mediated Tumor Immune Suppression to Enhance Immune Checkpoint Therapies”
- - - - - - - - - -
9-8-16 CC/Steve King: “Today, we are very pleased to announce that the topline data from our Phase III SUNRISE trial have been accepted for a late-breaking oral presentation at the upcoming European Society of Medical Oncology (ESMO) Congress to be held in Copenhagen in early October [Oct7-11]. ESMO is the premier European oncology meeting, attended by thousands of oncologists. The presentation at ESMO will be a great opportunity to share clinical data from the study in conjunction with initial results from ongoing biomarker analysis, which are already highly encouraging. Biomarker analysis was built into the SUNRISE trial from the beginning, including the collection of thousands of patient samples that could be analyzed once of the trial was unblinded. The primary goal the biomarker analysis is to identify a biomarker pattern, present in patients that receive the most benefit from a bavituximab containing therapeutic regimen, and we look forward to sharing the results of the ongoing analysis, with more data expected later in the year. The impact of the effective biomarker identification is already quite evident in oncology drug development, with the latest evidence being PD1/PD-L1 in the development of Keytruda. These types of biomarkers can only be identified through analysis of larger patient populations, such as in the SUNRISE trial. The results of identifying effective biomarkers can potentially have a huge impact on clinical development, potentially reducing the size of future trials, including making possible biomarker-driven clinical designs which could provide even more rapid readouts. Taken together, these developments are setting the stage for new data throughout the rest of 2016 and into 2017.” http://tinyurl.com/jydtkoy
9-8-16 CC/Joe Shan: “QWe are very excited to have the opportunity for a late-breaking oral presentation on the Phase III SUNRISE trial at the ESMO Congress about a month from now [Oct7-11 http://www.esmo.org/Conferences/ESMO-2016-Congress ]. Even as the trial continues to wind down, treatment, follow-up, and data collection are still ongoing for a number of patients, with some continuing to receive bavituximab over a year. At ESMO, we will be presenting both topline clinical data from the trial as well as initial results from our ongoing biomarker analysis, the results of which have been promising to-date. Because these data have been accepted for presentation at ESMO, they are under embargo until the actual presentation, but we will provide addl. details on the ESMO presentation and our findings as soon as we can. As a reminder, the biomarker program was prospectively built into the SUNRISE protocol, and is designed to help us better understand how bavituximab works and which patients may benefit most. This is a massive effort, and though there are still much ongoing sample testing and data analysis, our goal is to share these results as they become available throughout the rest of this year and into 2017.” http://tinyurl.com/jydtkoy
9-8-16 CC/Rob Garnick: “I’d like to emphasize the strategic importance of the biomarker study, which, as Joe said, was built into the SUNRISE trial. The identification of a positive biomarker or relevant biomarker pattern with clinical efficacy is an important facet of clinical trial design that can be used to inform addl. new studies that in turn might be used to select patients who would best benefit from bavituximab therapy. For example, the identification of the HER2 biomarker was critical in the development of Herceptin. Its importance was only critically established based on the results of a Phase II clinical trial. As Steve previously described, the critical role of the PD-L1 biomarker is emerging as a major factor in the selection of patients for the clinical use of Opdivo & Keytruda. In the case of bavituximab, once a promising biomarker or biomarker pattern is identified, we strategically plan to include these results into potential new clinical trials.” http://tinyurl.com/jydtkoy
9-8-16 CC/Jeff Hutchins: “I would now like to provide an update on Peregrine's preclinical I-O focused internal efforts and our collaboration with Memorial Sloan Kettering CC. The goal of this work is to evaluate combinations of PS targeting with other checkpoint inhibitors and immune stimulatory agents for the purpose of developing new and increasingly effective anticancer treatments. These programs are advancing well and to-date, we have seen impressive signs of activity with new combinations of PS targeting and other treatment modalities such as checkpoint blockers, T-cell agonists and radiation. These new combinations are improving overall survival accompanied with increases in cyto-reactive T cells into the tumor tissue. This exciting new internal work will be presented at the CRI/AACR Immunotherapy Meeting in NY later this month and at ESMO in early October. We expect the first results from our collaboration with the Wolchok Lab investigators to be presented at SITC in November and we will provide more detailed information as that presentation becomes available.” http://tinyurl.com/jydtkoy
Oh my, Rutger’s DR.RAYMOND.BIRGE w/Peregrine Researchers, AACR-CRI/Sept26/NYC. This involves Peregrine’s “preclinical I-O focused internal efforts”, which Jeff Hutchins (VP/PreClin.Res) described in the 9-8-16 CC as, “advancing well, and we have seen impressive signs of activity with new combinations of PS targeting and other treatment modalities such as checkpoint blockers, T-cell agonists and radiation.” - see Dr. Hutchin’s 9-8-16 comments below. Clearly new work – way over my head. Lead Author of #B119: Dr. Raymond B. Birge!!
Sept25-28 2016: “2nd CRI-CIMT-EATI-AACR Intl. Cancer Immunotherapy Conf.”, NYC
“The pgm will focus on “Translating Science into Survival” and feature talks from more than 60 leaders in the field covering all areas of inquiry in cancer immunology and immunotherapy.”
http://www.aacr.org/Meetings/Pages/MeetingDetail.aspx?EventItemID=101
ABSTRACTS: http://www.cancerimmunotherapyconference.org/abstracts
9-26-16 5:15-7:45pm: Poster Session B
-----
Track: NEW AGENTS AND THEIR MODE OF ACTION IN ANIMALS AND HUMANS
I. #B019 “LAG3 is an Immunotherapeutic Target in Murine Triple- Breast Cancers, Whose Activity is Significantly Enhanced in Combination with Phosphatidylserine Targeting Antibodies”
Michael J. Gray, Jian Gong, Jeff Hutchins, Bruce Freimark (Peregrine Pharmaceuticals)
-----
Track: MECHANISTIC MERGING OF TREATMENT MODALITIES
II. #B119 “Characterization of a Phosphatidylserine, TAM Receptor (Tyro3, Axl, Mertk), PDL1 Axis in Breast Cancer”
Canan Kasikara 1, Sushil Kumar 1, Ke Geng 1, Viral Davre 1, Cyril Empig 2, Bruce Freimark 2, Michael Gray 2, Kyle Schlunegger 2, Jeff Hutchins 2, Sergei V. Kotenko 1, Raymond B. Birge 1
1=Rutgers, New Jersey Medical School, Newark, NJ
2=Peregrine Pharmaceuticals, Tustin
- - - - -
9-8-16 CC/Jeff Hutchins: “I would now like to provide an update on Peregrine's preclinical I-O focused internal efforts and our collaboration with Memorial Sloan Kettering CC. The goal of this work is to evaluate combinations of PS targeting with other checkpoint inhibitors and immune stimulatory agents for the purpose of developing new and increasingly effective anticancer treatments. These programs are advancing well and to-date, we have seen impressive signs of activity with new combinations of PS targeting and other treatment modalities such as checkpoint blockers, T-cell agonists and radiation. These new combinations are improving overall survival accompanied with increases in cyto-reactive T cells into the tumor tissue. This exciting new internal work will be presented at the CRI/AACR Immunotherapy Meeting in NY later this month and at ESMO in early October. We expect the first results from our collaboration with the Wolchok Lab investigators to be presented at SITC in November and we will provide more detailed information as that presentation becomes available.” http://tinyurl.com/jydtkoy
= = = = = = =
2-2016: Rutgers' Dr. Raymond Birge's relationship with Peregrine & UTSW's Dr. Rolf Brekken and his 2-26-16 article, “Phosphatidylserine is a Global Immunosuppressive Signal in Efferocytosis, Infectious Disease, and Cancer” http://tinyurl.com/z5d9qt9
11-9-15 SITC'15: New Bavi+Checkpoint Inhibitors preclin. data (UTSW/DUKE's Herbert K. Lyerly) http://tinyurl.com/pbof95w
...Also, collab. with Dr. Bernard Fox (Immunotherapist/Earle A. Chiles Res.Inst.) on new Immuno-Profiling Clinical Test (Opal 6-plex quantitative IF Assay), PPHM roundtable with Raymond Birge (Rutgers), Douglas Graham (Emory), Dmitry Gabrilovich (Wistar), Rolf Brekken (UTSW), Maria Karasarides (AstraZeneca) - ”Combining Bavi w/anti-PD-1 significantly enhanced O/S… significant incr. CD45+, CD8+ and CD3+ T-cells… led a prolonged anti-tumor immune response which protected the animals against a re-challenge w/same tumor.”
= = = = = = = =DR. BIRGE:
...Dr. Raymond Birge has authored ~85 scientific publications in molecular & cancer biology. http://www.ncbi.nlm.nih.gov/pubmed/?term=birge+rb
“The Birge laboratory conducts basic science focused on the eradication of cancer.”
http://birgelab.org => http://birgelab.org/biography.html
They didn't "blame the revenue miss on testing in new facility."
SUGGEST YOU READ/LISTEN MORE CAREFULLY before calling people Clowns:
9-8-16 Qtly CC-Transcript, PR(Q1/FY17), updated Avid Revenues History Table By Qtr…
http://tinyurl.com/jydtkoy
9-8-16/PL: "Revenue for Q1 was lower than expected due to delays in 3rd-party testing labs that put revenue recognition for a number of mfg. runs from Q1 to Q2 of FY2017. As a result, contract mfg. revenue for Q1 was $5.6mm, compared to $9.4mm for the same qtr last year. However, as these revenues shift, we now expect to recognize revenue in excess of $20mm in Q2/FY2017... And it's important to note that our projected revenue growth is supported by current revenue backlog of $71mm under signed contacts covering services to be completed during the remainder of FY17 and into FY18."
9-8-16/SK/Q&A: "We think it's an anomaly and so we don't expect this to be an ongoing issue. The issue is basically, the testing labs were so busy, there was a backlog or line to get into the queue to actually get the testing completed. Of course, we can't release lots without all the testing results and we can't ship them until they are released, and that's the reason that it hit the bottom line this quarter. We think it’s an anomaly. It's nothing to do with testing results, per se, for the lots. it’s really just getting them in the line to get the testing done and that's the reason we are projecting that Q2 [q/e 10-31-16] will be such a big quarter, because now that backlog seems to have worked itself out and we’ve worked it into our planning to give ourselves a little bit more time. And so we think it's hopefully something that's behind us. Of course, we can't control all the 3rd-party laboratories, but we are certainly working directly with them as well to ensure that we are able to maintain a high priority for them because we do generate a significant amount of business for a lot of our vendors."
9-8-16/PR: AVID BIOSERVICES HIGHLIGHTS
"Our biomanufacturing business was extremely busy this past quarter as the team remained on track according to the planned production schedule including initiating several process validation runs and ongoing commercial mfg. activities. Despite being on track from a production standpoint, Q1/FY17 revenues were lower than expected due to a testing backlog at a 3rd-party testing laboratory that delayed the shipment of manufacturing runs. As a result of the backlog being resolved, we expect revenue to exceed $20mm in Q2 as we shift revenue recognition from the first quarter to Q2/FY17."
Jeff Hutchins(VP/PreClin.Res) today at NEO-SYNTH's Lung Cancer Summit/Boston
Sept13-14 2016: “NEO-SYNTH's Precision: Lung Cancer - World R&D Summit”, Boston
“Precision: Lung Cancer will bring together scientists & business leaders from pharma, biotech and academia, using extensive networking sessions to forge meaningful collaborations.”
http://precisionlungcancer.com
NEO-SYNTH: “Connecting The Pharma Industry By Forging Interactions” http://neo-synth.com
Agenda 9-13-16: http://precisionlungcancer.com/agenda--day-one.html
Agenda 9-14-16: http://precisionlungcancer.com/agenda--day-two.html
9-13-16 4:30pm: Speaker: Jeff Hutchins (VP/Prelin.Res., Peregrine), “Overriding Immune Suppression and Increasing TILs Through Blockade of the Phosphatidylserine Signaling Pathway”
= = = = = = = = = =KNOWN UPCOMING:
Sep13: NEO-SYNTH's "Precision: Lung Cancer - World R&D Summit", Boston http://tinyurl.com/hq9m8ej
...4:30pm: Dr. Jeff Hutchins(VP/PreClin.Res), ”Overriding Immune Suppression & Increasing TILs Through Blockade of the PS-Signaling Pathway”
Sep15: EXL's 11th Medical Affairs Executive Forum, SanDiego http://exlevents.com/medical-affairs-executive-forum-west
...11:15–12pm: Dr. Lisa Stepp, PPHM's PhD/Sen.Dir./MedAffairs, ”Effects of Co. Size on the Est. of an Advisory Board Benchmark”
Sep22: Phacilitate’s "Immunotherapy Europe" (Strategic Partnering Event), Berlin http://tinyurl.com/hwxax88
...9:50-10:20am WEBINAR - Steve King is Panelist w/BMS/Merck/Agenus: “Analyzing The Business & Partnering Model in Industry & Academia for the Future Dev. of I-O Combination Therapies”
Sep25-28: 2nd AACR-CRI Intl. Cancer Immunotherapy Conf.”, NYC http://www.aacr.org/Meetings/Pages/MeetingDetail.aspx?EventItemID=101
...”Exciting” internal preclin. work related to the MSK-Collab to be presented” (per 9-8-16/CCall/Hutchins)
Oct4-7/Avid/Booth#716: IBC's BioProcess Intl. Conf., Boston http://www.ibclifesciences.com/BPI/overview.xml & http://tinyurl.com/zyblds7
...10-5-16/8-8:30am: Peter Gagnon (Avid's VP/Process-Svcs), “Across the Great Divide: The Upstream Origins & Downstream Ramifications of a Newly Discovered Contaminant Class”
Oct7-11: 41th ESMO European Cancer Congress, Copenhagen, Denmark http://tinyurl.com/j2cng2y
...”Oral Presentation of Top-line data from the Ph3 SUNRISE trial” (per 9-8-16/PR)
...10-10-16 9:15-9:30am: Dr. David Gerber(UTSW) Proffered Oral Presentation, “Top-line Results from Ph3/SUNRISE... (incl. “initial results from ongoing biomarker analysis”)
...10-9-16 1:00-2:00pm: Jeff Hutchins(VP/PreClin.Res), “Antibody Mediated Blockade of PS Improves Immune Checkpoint Blockade...”
Oct13/10am: Annual SHM, Avenue of the Arts Hotel, Costa Mesa – Final Proxy: http://tinyurl.com/gsrmgs2
Nov9-13: (SITC) Society for Immunotherapy of Cancer 31st Annual Meeting”, Natl-Harbor MD http://www.sitcancer.org/2016
...”First Results” from our collaboration with Jedd Wolchok Lab investigators (MSK) to be presented” (per 9-8-16/Ccall/Hutchins)
~Dec8: FY'17Q2 (qe 10-31-16) Financials & Conf. Call - http://ir.peregrineinc.com/events.cfm
Dec11-15/Avid/Booth#209: IBC's Antibody Eng. & Therapeutics 2016”, SanDiego http://www.ibclifesciences.com/AntibodyEng/overview.xml
9-13-16 BioPharma article, “Avid To Construct 3rd Plant...”
9-13-16/BioPharma: ”Avid To Construct 3rd Plant With Two 1,000L Single-Use Bioreactors”
By: Dan Stanton, Editor, BioPharma-Reporter
http://www.biopharma-reporter.com/Upstream-Processing/Avid-to-construct-third-plant-with-two-1-000L-single-use-bioreactors
Avid Bioservices will construct a clinical mfg. plant later this year just months after production began at a 2nd facility. In December 2015 , Avid Bioservices – the contract mfg. subsidiary of Peregrine Pharmaceuticals – completed construction of the ‘Myford’ facility, its 2nd bioproduction plant housing single-use bioreactors of up to 2,000L. At the time the firm said it was already eyeing up extra capacity to cope with expected demand for contract monoclonal antibody mfg., and this week confirmed to Biopharma-Reporter that construction of a 3rd plant will begin in Q4 of CY2016.
“The new [Avid III] clinical suite is expected to be complete and ready for clinical mfg. activities by mid-2017,” we were told. The suite will incorporate two 1,000L single-use bioreactors and, like the firm’s current 2 facilities, will be located in Tustin, CA. “As Avid continues to expand both its services and mfg. capacity, we expect demand from biotechnology & pharmaceutical companies to remain high.”
$110M CONTRACT REVENUES
Last year, the firm’s Franklin facility pulled in around $40mm of revenue, and the new Myford plant is expected to generate the same annually. According to the firm’s financial projections, mfg. revenue for the full fiscal year 2017 is expected to be between $50-55mm. But the addition of the 3rd plant is expected to push total revenues for the CDMO to over $100mm, Peregrine’s CFO Paul Lytle said in a conference call to discuss the firm’s Q1 FY2107 results last week [9-8-16: http://tinyurl.com/jydtkoy ]. “We believe the 3rd facility will again significantly increase our mfg. capacity and all 3 mfg. facilities will have the potential to generate in total ~$110mm in annual revenue.” Furthermore, Peregrine reported a disappointing qtr with clinical and commercial biomfg. contributing $5.6m, a drop of 42% on the same qtr last year. The firm attributed this to a backlog at a 3rd-party testing lab that shifted the timing of revenue recognition from Q1 to Q2 of FY2017.
UTSW’s Dr.David.Gerber (SUNRISE ESMO’16/LeadAuthor) quoted in MOONSHOT article… Recall, Dr. Gerber is the Lead Author (presumably he’ll be the speaker) of the upcoming Oct. 10th ESMO’16 late-breaking Proffered Paper (Oral Presentation) of Topline data from the Phase III SUNRISE trial, including initial results from ongoing biomarker analysis, which CEO Steve King described in the 9-8-16 CC as “already highly encouraging”.
9-8-16/SciNews: “Panel Outlines Research Priorities for Cancer Moonshot”
https://www.sciencenews.org/article/panel-outlines-research-priorities-cancer-moonshot
...”Recommendations emphasize importance of data sharing, promise of immunotherapy” ...For treatment, the report singles out immunotherapy, which harnesses a patient’s own immune system to fight cancer. The strategy is widely regarded as one of the most significant advances in cancer care, even though so far only 10-20% of patients receiving such treatments show long-term benefit. “When I speak to my patients, I tell them that the greatest risk is disappointment,” says medical oncologist David Gerber of the Univ. of Texas SW Medical Center/Dallas. Nonetheless, he and others remain optimistic about immunotherapy’s potential, and he agrees with recommendations to speed up research. In proposing an immunotherapy clinical trials network, the report states that current treatments “represent only the tip of the iceberg of what is possible.”
- - - - - - - - - -Recall:
1-13-16: “JP Morgan - Jumping In Front Of The Cancer Immunotherapy Parade”
EP Vantage Newsletter Provider
Steven King, CEO of Peregrine Pharmaceuticals, sees the potential for this (Cancer MoonShot 2020) initiative to offer an opportunity for smaller companies to run more combination trials. While Peregrine is planning a trial in combination of its immuno-oncology agent bavituximab with AstraZeneca’s durvalumab and is collaborating with the National Comprehensive Cancer Network (NCCN) for other combination trials, this coalition might serve to stimulate an expansion of clinical work. “It’s often access to drugs. If you want to run a combination with Keytruda or Opdivo, you’re going to have to buy the drug,” he told EP Vantage in an interview on the sidelines of the JP Morgan meeting. “It becomes a cost issue. You’re not going to be able to run as many studies.”
MORE: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=119836127
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9-8-16/CC/Steve King: “Topline data from our Phase III SUNRISE trial have been accepted for a late-breaking oral presentation [10-10-16, Dr. David Gerber, UTSW, Lead Author – see below] at the upcoming European Society of Medical Oncology (ESMO) Congress to be held in Copenhagen in early October [Oct7-11]. ESMO is the premier European oncology meeting, attended by thousands of oncologists. The presentation at ESMO will be a great opportunity to share clinical data from the study in conjunction with initial results from ongoing biomarker analysis, which are already highly encouraging. Biomarker analysis was built into the SUNRISE trial from the beginning, including the collection of thousands of patient samples that could be analyzed once of the trial was unblinded. The primary goal the biomarker analysis is to identify a biomarker pattern, present in patients that receive the most benefit from a bavituximab containing therapeutic regimen, and we look forward to sharing the results of the ongoing analysis, with more data expected later in the year. The impact of the effective biomarker identification is already quite evident in oncology drug development, with the latest evidence being PD1/PD-L1 in the development of Keytruda. These types of biomarkers can only be identified through analysis of larger patient populations, such as in the SUNRISE trial. The results of identifying effective biomarkers can potentially have a huge impact on clinical development, potentially reducing the size of future trials, including making possible biomarker-driven clinical designs which could provide even more rapid readouts. Taken together, these developments are setting the stage for new data throughout the rest of 2016 and into 2017.” http://tinyurl.com/jmy77g3
= = = = = = = = = = = = = = = =
Oct7-11 2016: “41st ESMO European Cancer Congress”, Copenhagen, Denmark
http://www.esmo.org/Conferences/ESMO-2016-Congress
ESMO = European Society for Medical Oncology
ECCO = European CanCer Organization
Pgm: http://www.esmo.org/Conferences/ESMO-2016-Congress/Programme
I. 10-9-16 1:00-2:00pm: POSTERS - Topic: Immunotherapy of Cancer
#1074P: “Antibody Mediated Blockade of Phosphatidylserine Improves Immune Checkpoint Blockade by Repolarizing Immune Suppressive Mechanisms of the Tumor Microenvironment” - Jeff Hutchins(VP/PreClin.Res), Peregrine Pharmaceuticals (pg.165)
9-8-16/CC/JeffH: “Exciting new internal work on PPHM’s I-O preclin. studies (Jeff Hutchins) will be presented.”
- - - - - - - - -
II. 10-10-16 Type: Proffered Paper Session* - “NSCLC/Metastatic2”
-----
*Proffered Paper Session = Oral presentations by authors presenting original data of superior quality, followed by expert discussion and perspectives.
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Chairs: Fiona Blackhall(GB); Tony S.K. Mok(Hong Kong)
10-10-16 9:15-9:30am #LBA45: “Top-line Results from SUNRISE: A Phase III, Randomized, Double-Blind, Placebo-Ctl’d Multicenter Trial of Bavituximab + Docetaxel in Patients with Previously Treated Stage IIIb/IV Non-Squamous NSCLC”
D. Spigel 1, I. Bondarenko 2, G. Losonczy 3, J. Mezger 4, H. Kalofonos 5, M. Reck 6, R. Palmero 7, T. Jang 8, R. Natale 9, R. Sanborn 10, J. Lai 11, N. Kallinteris 12, M. Tang 11, J. Shan 13, David E. Gerber(MD, UTSW – Lead Author)** 14
1=Nashville TN; 2=Dnepropetrovsk, UA, 3=Budapest, HU, 4=Karlsruhe, DE, 5=Patras, GR, 6=Grosshansdorf, DE, 7=Barcelona, ES, 8=Busan, KR, 9=Los Angeles CA, 10=Portland OR, 11/12/13=Tustin CA; 14=UTSW/Dallas
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**UTSW’s Dr. David Gerber presented Prelim. SUNRISE Data 5-31-14 at ASCO’14 – see http://tinyurl.com/nv4jloo )
= = = = = = = = = = = = =
BAVITUXIMAB "SUNRISE" PHASE III TRIAL: http://www.SunriseTrial.com
A. Phase III Bavi+Doce vs. 2nd-Line NSCLC "SUNRISE" (randomized, double-blind, placebo-ctl'd, n=582)
USA Protocol: http://www.clinicaltrials.gov/ct2/show/NCT01999673
...2 ARMS: A=BAVI/3mg+DOCE(Weekly), B=Doce+Placebo(Weekly)
...161 sites a/o 7-9-15 (USA/39 Aus/9 Bel/7 Fr/9 Ger/15 Greece/10 Hungary/7 Italy/10 Korea/9 Rom/6 Rus/8 Spain/16 Taiwan/10 Ukraine/6) - Growth: http://tinyurl.com/qbemrr2
2-25-16: IDMC Halts SUNRISE at 1st Look-in. Bavi+Doce arm “OS performing as expected”; Doce arm “dramatically outperforming OS expectations” http://tinyurl.com/jbg48vs
5-31-14 ASCO’14: David Gerber/Joe Shan Poster on Ph3/SUNRISE Trial (#TPS8129) http://tinyurl.com/nv4jloo
.
.
.
3 NCCN Bavituximab Trials Announced 9-6-16 – "Early 2017" (Moffitt, MassGEN, JohnHopkins) http://tinyurl.com/hj8yeuz
#1: Ph1/HepC-Related Hepatocellular (Bavi+RAD+Sorafenib), MOFFITT CANCER CENTER - PI: Jessica Frakes, MD
"A Phase I Trial of Sorafenib & Bavituximab + Stereotactic Body Radiation Therapy (SBRT) for Unresectable Hepatitis C Associated Hepatocellular Carcinoma"
=> 9-8-16/CC/JoeShan: “The 1st award is for a Phase I trial of Sorafenib [Bayer’s Nexavar] and bavituximab + radiation in Hepatocellular Carcinoma. This will build on a previously reported investigator sponsored Phase II trial of bavituximab & sorafenib in Liver Cancer. [3-25-15/Dr.Adam.Yopp(UTSW)/Ph2data, N=38: http://tinyurl.com/opkh5qy ]”
#2: P1-2/Newly Diag. Glioblastoma (Bavi+RAD+Merck’s Temodar), MASS-GEN. CANCER CENTER - PI: Elizabeth Gerstner, MD
"Phase I/II Clinical Trial of Bavituximab with Radiation & Temozolomide(Temodar) for Patients with Newly Diagnosed Glioblastoma"
=> 9-8-16/CC/JoeShan: “The 2nd award is for a Phase I/II trial of bavituximab with radiation + temozolomide [Merck’s Temodar] in newly diagnosed Glioblastoma. This trial is supported by some of our most impressive preclinical data demonstrating long-term survival in a lethal brain cancer model and that surviving rats were immune from tumor re-challenge.”
#3: Ph2/Progressive Squamous Head+Neck (Bavi+Merck’s Keytruda), JOHN-HOPKINS(Sidney Kimmel CC) - PI: Ranee Mehra, MD
”Phase II Study of Pembrolizumab & Bavituximab for Progressive Recurrent/Metastatic Squamous Cell Carcinoma of the Head & Neck"
=> 9-8-16/CC/JoeShan: “The 3rd award is for a Phase II study of pembrolizumab [Merck’s Keytruda, anti-PD-1] & bavituximab in Head & Neck Cancer. We are particularly excited about this project, as it will be the first clinical trial of bavituximab with a checkpoint inhibitor. In multiple previous preclin. studies, we have observed bavituximab's potential to work synergistically with PD1 inhibitors such as pembrolizumab.”
Per the ESMO’16 website: Proffered Paper Session = "Oral Presentations by authors presenting original data of superior quality, followed by expert discussion and perspectives.” CEO Steve King in the 9-8-16 CC referred to the "initial SUNRISE biomarker results" that are to be presented 10-10-16 at ESMO'16 as "already highly encouraging" (see below).
= = = = = = = = = = = =
Oct7-11 2016: “41st ESMO European Cancer Congress”, Copenhagen, Denmark
http://www.esmo.org/Conferences/ESMO-2016-Congress
ESMO = European Society for Medical Oncology
ECCO = European CanCer Organization
Pgm: http://www.esmo.org/Conferences/ESMO-2016-Congress/Programme
I. 10-9-16 1:00-2:00pm: POSTERS - Topic: Immunotherapy of Cancer
#1074P: “Antibody Mediated Blockade of Phosphatidylserine Improves Immune Checkpoint Blockade by Repolarizing Immune Suppressive Mechanisms of the Tumor Microenvironment” - Jeff Hutchins(VP/PreClin.Res), Peregrine Pharmaceuticals (pg.165)
9-8-16/CC/JeffH: “Exciting new internal work on PPHM’s I-O preclin. studies (Jeff Hutchins) will be presented.”
- - - - - - - - -
II. 10-10-16 Type: Proffered Paper Session* - “NSCLC/Metastatic2”
- - - - - - - - -
*Proffered Paper Session = Oral Presentations by authors presenting original data of superior quality, followed by expert discussion and perspectives.
- - - - - - - - -
Chairs: Fiona Blackhall(GB); Tony S.K. Mok(Hong Kong)
10-10-16 9:15-9:30am #LBA45: “Top-line Results from SUNRISE: A Phase III, Randomized, Double-Blind, Placebo-Ctl’d Multicenter Trial of Bavituximab + Docetaxel in Patients with Previously Treated Stage IIIb/IV Non-Squamous NSCLC”
D. Spigel 1, I. Bondarenko 2, G. Losonczy 3, J. Mezger 4, H. Kalofonos 5, M. Reck 6, R. Palmero 7, T. Jang 8, R. Natale 9, R. Sanborn 10, J. Lai 11, N. Kallinteris 12, M. Tang 11, J. Shan 13, David E. Gerber(MD, UTSW – Lead Author)** 14
1=Nashville TN; 2=Dnepropetrovsk, UA, 3=Budapest, HU, 4=Karlsruhe, DE, 5=Patras, GR, 6=Grosshansdorf, DE, 7=Barcelona, ES, 8=Busan, KR, 9=Los Angeles CA, 10=Portland OR, 11/12/13=Tustin CA; 14=UTSW/Dallas
**UTSW’s Dr. David Gerber presented Prelim. SUNRISE Data 5-31-14 at ASCO’14 – see http://tinyurl.com/nv4jloo )
.
.
9-8-16/CC/Steve King: “Topline data from our Phase III SUNRISE trial have been accepted for a late-breaking oral presentation [10-10-16, Dr. David Gerber, UTSW, Lead Author] at the upcoming European Society of Medical Oncology (ESMO) Congress to be held in Copenhagen in early October [Oct7-11]. ESMO is the premier European oncology meeting, attended by thousands of oncologists. The presentation at ESMO will be a great opportunity to share clinical data from the study in conjunction with initial results from ongoing biomarker analysis, which are already highly encouraging. Biomarker analysis was built into the SUNRISE trial from the beginning, including the collection of thousands of patient samples that could be analyzed once of the trial was unblinded. The primary goal the biomarker analysis is to identify a biomarker pattern, present in patients that receive the most benefit from a bavituximab containing therapeutic regimen, and we look forward to sharing the results of the ongoing analysis, with more data expected later in the year. The impact of the effective biomarker identification is already quite evident in oncology drug development, with the latest evidence being PD1/PD-L1 in the development of Keytruda. These types of biomarkers can only be identified through analysis of larger patient populations, such as in the SUNRISE trial. The results of identifying effective biomarkers can potentially have a huge impact on clinical development, potentially reducing the size of future trials, including making possible biomarker-driven clinical designs which could provide even more rapid readouts. Taken together, these developments are setting the stage for new data throughout the rest of 2016 and into 2017.” http://tinyurl.com/jmy77g3
10-10-16: Topline SUNRISE Data Oral Pres. at ESMO’16/Copenhagen
9-8-16/CC/Steve King: “Topline data from our Phase III SUNRISE trial have been accepted for a late-breaking oral presentation [10-10-16, Dr. David Gerber, UTSW, Lead Author – see below] at the upcoming European Society of Medical Oncology (ESMO) Congress to be held in Copenhagen in early October [Oct7-11]. ESMO is the premier European oncology meeting, attended by thousands of oncologists. The presentation at ESMO will be a great opportunity to share clinical data from the study in conjunction with initial results from ongoing biomarker analysis, which are already highly encouraging. Biomarker analysis was built into the SUNRISE trial from the beginning, including the collection of thousands of patient samples that could be analyzed once of the trial was unblinded. The primary goal the biomarker analysis is to identify a biomarker pattern, present in patients that receive the most benefit from a bavituximab containing therapeutic regimen, and we look forward to sharing the results of the ongoing analysis, with more data expected later in the year. The impact of the effective biomarker identification is already quite evident in oncology drug development, with the latest evidence being PD1/PD-L1 in the development of Keytruda. These types of biomarkers can only be identified through analysis of larger patient populations, such as in the SUNRISE trial. The results of identifying effective biomarkers can potentially have a huge impact on clinical development, potentially reducing the size of future trials, including making possible biomarker-driven clinical designs which could provide even more rapid readouts. Taken together, these developments are setting the stage for new data throughout the rest of 2016 and into 2017.” http://tinyurl.com/jmy77g3
Oct7-11 2016: “41st ESMO European Cancer Congress”, Copenhagen, Denmark
http://www.esmo.org/Conferences/ESMO-2016-Congress
ESMO = European Society for Medical Oncology
ECCO = European CanCer Organization
Pgm: http://www.esmo.org/Conferences/ESMO-2016-Congress/Programme
I. 10-9-16 1:00-2:00pm: POSTERS - Topic: Immunotherapy of Cancer
#1074P: “Antibody Mediated Blockade of Phosphatidylserine Improves Immune Checkpoint Blockade by Repolarizing Immune Suppressive Mechanisms of the Tumor Microenvironment” - Jeff Hutchins(VP/PreClin.Res), Peregrine Pharmaceuticals (pg.165)
9-8-16/CC/JeffH: “Exciting new internal work on PPHM’s I-O preclin. studies (Jeff Hutchins) will be presented.”
- - - - - - - - -
II. 10-10-16 Type: Proffered Paper Session* - “NSCLC/Metastatic2”
*Proffered Paper Session = Oral presentations by authors presenting original data of superior quality, followed by expert discussion and perspectives.
Chairs: Fiona Blackhall(GB); Tony S.K. Mok(Hong Kong)
10-10-16 9:15-9:30am #LBA45: “Top-line Results from SUNRISE: A Phase III, Randomized, Double-Blind, Placebo-Ctl’d Multicenter Trial of Bavituximab + Docetaxel in Patients with Previously Treated Stage IIIb/IV Non-Squamous NSCLC”
D. Spigel 1, I. Bondarenko 2, G. Losonczy 3, J. Mezger 4, H. Kalofonos 5, M. Reck 6, R. Palmero 7, T. Jang 8, R. Natale 9, R. Sanborn 10, J. Lai 11, N. Kallinteris 12, M. Tang 11, J. Shan 13, David E. Gerber(MD, UTSW – Lead Author)** 14
1=Nashville TN; 2=Dnepropetrovsk, UA, 3=Budapest, HU, 4=Karlsruhe, DE, 5=Patras, GR, 6=Grosshansdorf, DE, 7=Barcelona, ES, 8=Busan, KR, 9=Los Angeles CA, 10=Portland OR, 11/12/13=Tustin CA; 14=UTSW/Dallas
**UTSW’s Dr. David Gerber presented Prelim. SUNRISE Data 5-31-14 at ASCO’14 – see http://tinyurl.com/nv4jloo )
= = = = = = = = = = = = =
BAVITUXIMAB "SUNRISE" PHASE III TRIAL: http://www.SunriseTrial.com
A. Phase III Bavi+Doce vs. 2nd-Line NSCLC "SUNRISE" (randomized, double-blind, placebo-ctl'd, n=582)
USA Protocol: http://www.clinicaltrials.gov/ct2/show/NCT01999673
...2 ARMS: A=BAVI/3mg+DOCE(Weekly), B=Doce+Placebo(Weekly)
...161 sites a/o 7-9-15 (USA/39 Aus/9 Bel/7 Fr/9 Ger/15 Greece/10 Hungary/7 Italy/10 Korea/9 Rom/6 Rus/8 Spain/16 Taiwan/10 Ukraine/6) - Growth: http://tinyurl.com/qbemrr2
2-25-16: IDMC Halts SUNRISE at 1st Look-in. Bavi+Doce arm “OS performing as expected”; Doce arm “dramatically outperforming OS expectations” http://tinyurl.com/jbg48vs
5-31-14 ASCO’14: David Gerber/Joe Shan Poster on Ph3/SUNRISE Trial (#TPS8129) http://tinyurl.com/nv4jloo
Just like on 7-14-16 the morning of the Q4/CC, you “predicted” $12mm for Q4, after Peregrine had PR’d on 6-2-16 that FY’16 revs would be $44mm, meaning Q4 had to be at least $18.4mm. Turned out they were $18.8mm. Not another word about that, you moved onto your Rob Garnick is gone assertion, and then etc etc etc.
“I will go with $39mm and $12mm.”
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=123864929
9-8-16/CC/P.Lytle: “We now expect to recognize revenue in excess of $20mm in Q2/FY2017. I would also like to reaffirm our full FY2017 revenue guidance of $50-55mm, representing up to 24% and yr-over-yr growth compared to last FY. And it's important to note that our projected revenue growth is supported by current revenue backlog of $71mm under signed contacts covering services to be completed during the remainder of FY17 and into FY18.” http://tinyurl.com/jydtkoy
3 NCCN Bavituximab Trials Announced 9-6-16 – "Early2017" (Moffitt, MassGEN, JohnHopkins)
#1: Ph1/HepC-Related Hepatocellular (Bavi+RAD+Sorafenib), MOFFITT CANCER CENTER - PI: Jessica Frakes, MD
"A Phase I Trial of Sorafenib & Bavituximab + Stereotactic Body Radiation Therapy (SBRT) for Unresectable Hepatitis C Associated Hepatocellular Carcinoma"
=> 9-8-16/CC/JoeShan: “The 1st award is for a Phase I trial of Sorafenib [Bayer’s Nexavar] and bavituximab + radiation in Hepatocellular Carcinoma. This will build on a previously reported investigator sponsored Phase II trial of bavituximab & sorafenib in Liver Cancer. [3-25-15/Dr.Adam.Yopp(UTSW)/Ph2data, N=38: http://tinyurl.com/opkh5qy ]”
#2: P1-2/Newly Diag. Glioblastoma (Bavi+RAD+Merck’s Temodar), MASS-GEN. CANCER CENTER - PI: Elizabeth Gerstner, MD
"Phase I/II Clinical Trial of Bavituximab with Radiation & Temozolomide(Temodar) for Patients with Newly Diagnosed Glioblastoma"
=> 9-8-16/CC/JoeShan: “The 2nd award is for a Phase I/II trial of bavituximab with radiation + temozolomide [Merck’s Temodar] in newly diagnosed Glioblastoma. This trial is supported by some of our most impressive preclinical data demonstrating long-term survival in a lethal brain cancer model and that surviving rats were immune from tumor re-challenge.”
#3: Ph2/Progressive Squamous Head+Neck (Bavi+Merck’s Keytruda), JOHN-HOPKINS(Sidney Kimmel CC) - PI: Ranee Mehra, MD
”Phase II Study of Pembrolizumab & Bavituximab for Progressive Recurrent/Metastatic Squamous Cell Carcinoma of the Head & Neck"
=> 9-8-16/CC/JoeShan: “The 3rd award is for a Phase II study of pembrolizumab [Merck’s Keytruda, anti-PD-1] & bavituximab in Head & Neck Cancer. We are particularly excited about this project, as it will be the first clinical trial of bavituximab with a checkpoint inhibitor. In multiple previous preclin. studies, we have observed bavituximab's potential to work synergistically with PD1 inhibitors such as pembrolizumab.”
- - - - - - - - - -
Joe Shan 9-8-16/CC: “These 3 studies align with our overall dev. strategy and will add to our knowledge about bavituximab-focused cancer treatment combinations. While we are not directly involved with these studies, we’ll be watching the progress carefully and look forward to providing an updates on the 3 NCCN trials in the coming months.”
Steve King 9-8-16/CC: “Our collaboration with the NCCN has been an important part of our strategy for advancing the bavituximab clinical program in a cost effective way. We earlier provided NCCN with a $2mm grant to support bavituximab related clinical research with no further financial obligations, and these grant awards represent the outcome of a competitive selection process for the best proposals. These studies will evaluate novel bavituximab combinations in Glioblastoma, Head & Neck Cancer, and Hepatocellular Carcinoma including an immunotherapy combination [Bavi + Merck’s Keytruda], which is a major focus for advancing the program.”
Steve King 9-8-16/CC/Q&A: “I’m very excited about the combinations that were chosen because the Radiation combination is one that in preclinical studies, as was mentioned during the prepared remarks, has always shown a lot of promise. It’s great to be able to now see that put into a clinical setting in a couple of different clinical trials. And the I-O combinations, as Jeff mentioned during his prepared remarks, is a major focus of ours. So to see a Pembro [Keytruda] combination picked as well, we are just really excited that these were the 3 winners out of the NCCN selection process.”
= = = = = = = =9-6-16/PR http://tinyurl.com/gutgwb5
"Our collaboration with NCCN provides the unique opportunity to support the group's highly-regarded research institutions and advance our understanding of the potential role of bavituximab in the treatment of various cancers. With this in mind, we were very pleased by the level of interest shown in bavituximab from the NCCN community and are grateful to all those who submitted their projects for rigorous evaluation by the ORP scientific review committee," said Joseph Shan, MPH, VP, Clinical & Regulatory Affairs of Peregrine. "We'd like to extend our congratulations to the 3 investigators who were selected for their unique and innovative concepts. These studies align with our development strategy for bavituximab which is currently focused on small, early stage clinical trials evaluating the drug in combination with other cancer treatments. Collaborators such as NCCN play a central role in this strategy and we look forward to integrating the valuable clinical data generated by these investigators to expand our knowledge regarding bavituximab-focused cancer treatment combinations."
Bavituximab is an investigational chimeric monoclonal antibody that targets phosphatidylserine (PS). Signals from PS inhibit the ability of immune cells to recognize and fight tumors. Bavituximab is believed to override PS mediated immunosuppressive signaling by blocking the engagement of PS with its receptors as well as by sending an alternate immune activating signal. PS targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and anti-tumor immune responses.
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9-8-16 Qtly. Conf. Call (King/Shan/Garnick/Hutchins/Lytle) Transcript http://tinyurl.com/jydtkoy
...CEO SK: “Our ultimate goal remains to reach overall profitability within the next 21mos, and Avid will be an important driver for achieving that goal, in combination with making strategic investments in our R&D while pursuing partnerships to help advance our programs.”
9-6-16: NCCN to Initiate 3 Bavi-Trials Early’17 (Moffitt, MassGEN, JohnHopkins) http://tinyurl.com/gutgwb5
=> Ph1/HepC-Related-Hepatocellular/MOFFITT, Ph1-2/Glioblastoma/MASS-GEN, Ph2/Head+Neck/JOHN-HOPKINS
1-6-16: Peregrine enters into Research Collab. with Natl-Comprehensive-Cancer-Network (NCCN) http://tinyurl.com/zmxtpsb
...$2mm res. grant to NCCN's Oncology Res. Pgm (ORP), will “significantly expand our clinical evaluation of Bavi and augment Peregrine's IST pgm at 26 of the world's leading cancer centers”.
3-9-16 Qtly. Conf. Call (King/Shan/Worsley/Lytle) Transcript http://tinyurl.com/gom7md5
...CEO SK: “Peregrine remains a strong company with a valuable clinical asset and a rapidly growing biomanufacturing business... We believe our relationships with AstraZeneca, Mem. Sloan Kettering, UTSW, & NCCN will be invaluable as we establish & execute our overall strategy for advancing the bavituximab I-O combination plans in a range of cancers.”
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9-6-16: National Comprehensive Cancer Network (NCCN) Awards 3 Grants for Combination Studies of Peregrine Pharmaceuticals' Bavituximab in Multiple Cancers
Peregrine's Novel PS-Targeting Immuno-Oncology (I-O) Agent to be Combined with Immunotherapy and Traditional Cancer Treatments in Studies Focused on Glioblastoma, Head and Neck Cancer and Hepatocellular Carcinoma
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=987864
TUSTIN, Sept. 6, 2016: Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM, PPHMP), a biopharmaceutical company committed to improving patient lives by manufacturing high quality products for biotechnology and pharmaceutical companies and advancing its proprietary R&D pipeline, today announced that the National Comprehensive Cancer Network (NCCN®) Oncology Research Program (ORP) has awarded 3 grants to investigators to support research of bavituximab in combination with other therapeutics for the treatment of Glioblastoma, Head & Neck Cancer, and Hepatocellular Carcinoma.
NCCN, a not-for-profit alliance of 27 of the world's leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Funding for the three investigator-initiated clinical studies will take place through a $2 million research grant made by Peregrine to NCCN's ORP. NCCN will be responsible for oversight and monitoring of the clinical studies through the research grant. It is expected that the selected trials will be initiated in early 2017.
"NCCN is excited to initiate three studies by accomplished investigators at NCCN Member Institutions that will explore the effect of this novel immunotherapy in three different cancers with significant unmet need," said Robert C. Young, MD, Interim VP, NCCN ORP.
The following NCCN-affiliated researchers were recipients of the grant awards:
1. Jessica Frakes, MD, Moffitt Cancer Center, "A Phase I Trial of Sorafenib and Bavituximab Plus Stereotactic Body Radiation Therapy (SBRT) for Unresectable Hepatitis C Associated Hepatocellular Carcinoma"
2. Elizabeth Gerstner, MD, Massachusetts General Hospital Cancer Center, "Phase I/II Clinical Trial of Bavituximab with Radiation and Temozolomide for Patients with Newly Diagnosed Glioblastoma"
3. Ranee Mehra, MD, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, "Phase II Study of Pembrolizumab [“Pembro”=MK-3475=Keytruda MERCK] & Bavituximab for Progressive Recurrent/Metastatic Squamous Cell Carcinoma of the Head & Neck"
"Our collaboration with NCCN provides the unique opportunity to support the group's highly-regarded research institutions and advance our understanding of the potential role of bavituximab in the treatment of various cancers. With this in mind, we were very pleased by the level of interest shown in bavituximab from the NCCN community and are grateful to all those who submitted their projects for rigorous evaluation by the ORP scientific review committee," said Joseph Shan, MPH, VP, Clinical & Regulatory Affairs of Peregrine. "We'd like to extend our congratulations to the 3 investigators who were selected for their unique and innovative concepts. These studies align with our development strategy for bavituximab which is currently focused on small, early stage clinical trials evaluating the drug in combination with other cancer treatments. Collaborators such as NCCN play a central role in this strategy and we look forward to integrating the valuable clinical data generated by these investigators to expand our knowledge regarding bavituximab-focused cancer treatment combinations."
Bavituximab is an investigational chimeric monoclonal antibody that targets phosphatidylserine (PS). Signals from PS inhibit the ability of immune cells to recognize and fight tumors. Bavituximab is believed to override PS mediated immunosuppressive signaling by blocking the engagement of PS with its receptors as well as by sending an alternate immune activating signal. PS targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and anti-tumor immune responses.
ABOUT PEREGRINE PHARMACEUTICALS, INC.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of patients by delivering high quality pharmaceutical products through its contract development and manufacturing organization (CDMO) services and through advancing and licensing its investigational immunotherapy and related products. Peregrine's in-house CDMO services, including cGMP manufacturing and development capabilities, are provided 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. The company is also working to evaluate its lead immunotherapy candidate, bavituximab, in combination with immune stimulating therapies for the treatment of various cancers, and developing its proprietary exosome technology for the detection and monitoring of cancer. For more information, please visit http://www.peregrineinc.com .
ABOUT THE NATIONAL COMPREHENSIVE CANCER NETWORK
The National Comprehensive Cancer Network® (NCCN®), a not-for-profit alliance of 27 of the world's leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers.
The NCCN Member Institutions are: Fred & Pamela Buffett Cancer Center, Omaha, NE; Case Comprehensive Cancer Center/University Hospitals Seidman Cancer Center and Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; City of Hope Comprehensive Cancer Center, Los Angeles, CA; Dana-Farber/Brigham and Women's Cancer Center | Massachusetts General Hospital Cancer Center, Boston, MA; Duke Cancer Institute, Durham, NC; Fox Chase Cancer Center, Philadelphia, PA; Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT; Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, WA; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL; Mayo Clinic Cancer Center, Phoenix/Scottsdale, AZ, Jacksonville, FL, and Rochester, MN; Memorial Sloan Kettering Cancer Center, New York, NY; Moffitt Cancer Center, Tampa, FL; The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute, Columbus, OH; Roswell Park Cancer Institute, Buffalo, NY; Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, MO; St. Jude Children's Research Hospital/The University of Tennessee Health Science Center, Memphis, TN ; Stanford Cancer Institute, Stanford, CA; University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL; UC San Diego Moores Cancer Center, La Jolla, CA; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; University of Colorado Cancer Center, Aurora, CO; University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; The University of Texas MD Anderson Cancer Center, Houston, TX; University of Wisconsin Carbone Cancer Center, Madison, WI; Vanderbilt-Ingram Cancer Center, Nashville, TN; and Yale Cancer Center/Smilow Cancer Hospital, New Haven, CT.
Clinicians, visit http://NCCN.org . Patients and caregivers, visit http://NCCN.org/patients . Media, visit http://NCCN.org/news .
= = = = = = = = = =Peregrine EVENTS that we know are coming up...
Sep13: NEO-SYNTH's "Precision: Lung Cancer - World R&D Summit", Boston http://tinyurl.com/hq9m8ej
...4:30pm: Dr. Jeff Hutchins(VP/PreClin.Res), ”Overriding Immune Suppression & Increasing TILs Through Blockade of the PS-Signaling Pathway”
Sep15: EXL's 11th Medical Affairs Executive Forum, SanDiego http://exlevents.com/medical-affairs-executive-forum-west
...11:15–12pm: Dr. Lisa Stepp, PPHM's PhD/Sen.Dir./MedAffairs, ”Effects of Co. Size on the Est. of an Advisory Board Benchmark”
Sep22: Phacilitate’s "Immunotherapy Europe" (Strategic Partnering Event), Berlin http://tinyurl.com/hwxax88
...9:50-10:20am WEBINAR - Steve King is Panelist w/BMS/Merck/Agenus: “Analyzing The Business & Partnering Model in Industry & Academia for the Future Dev. of I-O Combination Therapies”
Sep25-28: 2nd AACR-CRI Intl. Cancer Immunotherapy Conf.”, NYC http://www.aacr.org/Meetings/Pages/MeetingDetail.aspx?EventItemID=101
...”Exciting” internal preclin. work related to the MSK-Collab to be presented” (per 9-8-16/CCall/Hutchins)
Oct4-7/Avid/Booth#716: IBC's BioProcess Intl. Conf., Boston http://www.ibclifesciences.com/BPI/overview.xml & http://tinyurl.com/zyblds7
...10-5-16/8-8:30am: Peter Gagnon (Avid's VP/Process-Svcs), “Across the Great Divide: The Upstream Origins & Downstream Ramifications of a Newly Discovered Contaminant Class”
Oct7-11: 41th ESMO European Cancer Congress, Copenhagen, Denmark http://www.esmo.org/Conferences/ESMO-2016-Congress
...”Oral Presentation of Top-line data from the Ph3 SUNRISE trial” (per 9-8-16/PR)
Oct13/10am: Annual SHM, Avenue of the Arts Hotel, Costa Mesa – Final Proxy: http://tinyurl.com/gsrmgs2
Nov9-13: (SITC) Society for Immunotherapy of Cancer 31st Annual Meeting”, Natl-Harbor MD http://www.sitcancer.org/2016
...”First Results” from our collaboration with Jedd Wolchok Lab investigators (MSK) to be presented” (per 9-8-16/Ccall/Hutchins)
~Dec8: FY'17Q2 (qe 10-31-16) Financials & Conf. Call - http://ir.peregrineinc.com/events.cfm
Dec11-15/Avid/Booth#209: IBC's Antibody Eng. & Therapeutics 2016”, SanDiego http://www.ibclifesciences.com/AntibodyEng/overview.xml
Bidrite - “We expect the first results...Wolchok Lab...” - what we know (SITC Nov9-13)...
9-8-16/CC: JEFF HUTCHINS (VP/PreClinical Res.) http://tinyurl.com/jydtkoy
“. . .I would now like to provide an update on Peregrine's preclinical I-O focused internal efforts and our collaboration with Memorial Sloan Kettering Cancer Center. The goal of this work is to evaluate combinations of PS targeting with other checkpoint inhibitors and immune stimulatory agents for the purpose of developing new and increasingly effective anticancer treatments. These programs are advancing well and to-date, we have seen impressive signs of activity with new combinations of PS targeting and other treatment modalities such as checkpoint blockers, T-cell agonists and radiation. These new combinations are improving overall survival accompanied with increases in cyto-reactive T cells into the tumor tissue. This exciting new internal work will be presented at the AACR/CRI Immunotherapy Meeting in New York later this month [Sept25-28: http://www.aacr.org/Meetings/Pages/MeetingDetail.aspx?EventItemID=101 ] and at ESMO in early October [Oct7-11: http://www.esmo.org/Conferences/ESMO-2016-Congress ].
We expect the first results from our collaboration with MSK’s JEDD WOLCHOK LAB investigators [See MSK Collab: http://tinyurl.com/zkvebh6 ] to be presented at SITC in November [Nov9-13: http://www.sitcancer.org/2016 ] and we will provide more detailed information as that presentation becomes available.”
Nov9-13: (SITC) Society for Immunotherapy of Cancer 31st Annual Meeting”, Natl-Harbor MD http://www.sitcancer.org/2016
...”First Results” from our collaboration with Jedd Wolchok Lab investigators (MSK) to be presented” (per 9-8-16/Ccall/Hutchins)
EVENTS that we know are coming up...
Sep13: NEO-SYNTH's "Precision: Lung Cancer - World R&D Summit", Boston http://tinyurl.com/hq9m8ej
...4:30pm: Dr. Jeff Hutchins(VP/PreClin.Res), ”Overriding Immune Suppression & Increasing TILs Through Blockade of the PS-Signaling Pathway”
Sep15: EXL's 11th Medical Affairs Executive Forum, SanDiego http://exlevents.com/medical-affairs-executive-forum-west
...11:15–12pm: Dr. Lisa Stepp, PPHM's PhD/Sen.Dir./MedAffairs, ”Effects of Co. Size on the Est. of an Advisory Board Benchmark”
Sep22: Phacilitate’s "Immunotherapy Europe" (Strategic Partnering Event), Berlin http://tinyurl.com/hwxax88
...9:50-10:20am WEBINAR - Steve King is Panelist w/BMS/Merck/Agenus: “Analyzing The Business & Partnering Model in Industry & Academia for the Future Dev. of I-O Combination Therapies”
Sep25-28: 2nd AACR-CRI Intl. Cancer Immunotherapy Conf.”, NYC http://www.aacr.org/Meetings/Pages/MeetingDetail.aspx?EventItemID=101
...”Exciting” internal preclin. work related to the MSK-Collab to be presented” (per 9-8-16/CCall/Hutchins)
Oct4-7/Avid/Booth#716: IBC's BioProcess Intl. Conf., Boston http://www.ibclifesciences.com/BPI/overview.xml & http://tinyurl.com/zyblds7
...10-5-16/8-8:30am: Peter Gagnon (Avid's VP/Process-Svcs), “Across the Great Divide: The Upstream Origins & Downstream Ramifications of a Newly Discovered Contaminant Class”
Oct7-11: 41th ESMO European Cancer Congress, Copenhagen, Denmark http://www.esmo.org/Conferences/ESMO-2016-Congress
...”Oral Presentation of Top-line data from the Ph3 SUNRISE trial” (per 9-8-16/PR)
Oct13/10am: Annual SHM, Avenue of the Arts Hotel, Costa Mesa – Final Proxy: http://tinyurl.com/gsrmgs2
Nov9-13: (SITC) Society for Immunotherapy of Cancer 31st Annual Meeting”, Natl-Harbor MD http://www.sitcancer.org/2016
...”First Results” from our collaboration with Jedd Wolchok Lab investigators (MSK) to be presented” (per 9-8-16/Ccall/Hutchins)
~Dec8: FY'17Q2 (qe 10-31-16) Financials & Conf. Call - http://ir.peregrineinc.com/events.cfm
Dec11-15/Avid/Booth#209: IBC's Antibody Eng. & Therapeutics 2016”, SanDiego http://www.ibclifesciences.com/AntibodyEng/overview.xml
9-8-16 Qtly CC-Transcript, PR(Fins/Devs Q1FY17/qe7-31-16), updated Avid Revenues History Table By Quarter…
=> Total Revs May06-Jul16: $179.2mm/Avid + $24.1mm/Govt + $2.4mm/Lic. = $205.8mm.
Cash at 7-31-16: $44.2mm (Op. Cash Burn for q/e 7-31-16 was $9.6mm – see below).
As of Sept. 2, 2016, there were 242,381,850 shares outstanding.
There were NO ATM SALES from 7-15-16 – CURRENT(9-8-16) - see http://tinyurl.com/z9asadj
During 8/1/16-9/8/16, 68,910sh. of PREFERRED/10.5%SeriesE were sold for gross=$1,601,000 ($9,134,000 remain available).
This large post has 3 sections:
I. 9-8-16 Q1/FY17 Qtly. Earnings Conf. Call TRANSCRIPT (q/e 7-31-16)
II. 9-8-16 PPHM Press Release: Q1/FY17 Earnings & Developments
III. Updated Table of Avid Revenues By Quarter (May’06-Current)
…Recall: Peregrine’s FY runs May-Apr, so FY’17 = May’16-Apr’17.
((( Orig. transcript from SeekingAlpha.com [ http://tinyurl.com/jt7ljtf ], with numerous corrections made. )))
Link to webcast replay: http://ir.peregrineinc.com/events.cfm => http://edge.media-server.com/m/p/vdqbf8gx
FULL TRANSCRIPT…
9-8-2016 FY’17/Q1 Earnings Conf. Call (q/e 7-31-16)
WELCOME & FWD-LOOKING STATEMENTS: Tim Brons, Vida Strategic Partners (IR) http://www.peregrineinc.com
CEO STEVE KING – OPENING COMMENTS:
Thanks Tim and thanks to all of you who have dialed in and to all of you who are participating via webcast today. Since the start of the FY back in May, we have steadily advanced our R&D plans, as well as our contract mfg. growth strategies. On the R&D front, we recently announced that we had achieved 2 important milestones. beginning with the recent announcement that the National Comprehensive Cancer Network (NCCN) has awarded grants to 3 investigators to support bavituximab clinical research [9-6-16: http://tinyurl.com/gutgwb5 ]. Our collaboration with the NCCN has been an important part of our strategy for advancing the bavituximab clinical program in a cost effective way. We earlier provided NCCN with a $2mm grant to support bavituximab related clinical research with no further financial obligations, and these grant awards represent the outcome of a competitive selection process for the best proposals. These studies will evaluate novel bavituximab combinations in Glioblastoma, Head & Neck Cancer, and Hepatocellular Carcinoma including an immunotherapy combination [Bavi + Merck’s Keytruda], which is a major focus for advancing the program.
Today, we are very pleased to announce that the topline data from our Phase III SUNRISE trial have been accepted for a late-breaking oral presentation at the upcoming European Society of Medical Oncology (ESMO) Congress to be held in Copenhagen in early October [Oct7-11]. ESMO is the premier European oncology meeting, attended by thousands of oncologists. The presentation at ESMO will be a great opportunity to share clinical data from the study in conjunction with initial results from ongoing biomarker analysis, which are already highly encouraging. Biomarker analysis was built into the SUNRISE trial from the beginning, including the collection of thousands of patient samples that could be analyzed once of the trial was unblinded. The primary goal the biomarker analysis is to identify a biomarker pattern, present in patients that receive the most benefit from a bavituximab containing therapeutic regimen, and we look forward to sharing the results of the ongoing analysis, with more data expected later in the year. The impact of the effective biomarker identification is already quite evident in oncology drug development, with the latest evidence being PD1/PD-L1 in the development of Keytruda. These types of biomarkers can only be identified through analysis of larger patient populations, such as in the SUNRISE trial. The results of identifying effective biomarkers can potentially have a huge impact on clinical development, potentially reducing the size of future trials, including making possible biomarker-driven clinical designs which could provide even more rapid readouts. Taken together, these developments are setting the stage for new data throughout the rest of 2016 and into 2017. Joe, Jeff, and Rob will provide more insight as part of their prepared remarks.
On the mfg. front, it remains an extraordinarily busy time. We have remained on track for initiating & completing mfg. campaigns, keeping us on track to meet our current FY revenue projections. Our strategy for growing mfg. revenues remains on track as well, continuing to generate revenues in our Franklin facility which last year generated over $40mm in revenues, generate revenues from our new Myford facility, which is already booked well into next year and has another $40mm in revenue potential, and to bring online a new clinical production facility by mid next year which will allow us to continue introducing new clients into our business and to continue bringing in 2nd products from existing clients. The new facility will add another $30mm in revenue potential, and we have already identified a number of projects that can move into this facility as soon as it is completed. Paul will discuss the Avid business in more detail, as we continue to deliver high quality products for our partners. Our ultimate goal remains to reach overall profitability within the next 21 months, and Avid will be an important driver for achieving that goal, in combination with making strategic investments in our R&D while pursuing partnerships to help advance our programs. You can already see these plans playing out, as we are on track to grow revenues significantly this year while simultaneously seeing a significant decrease in R&D spending during the quarter, even though we are continuing to advance our programs. I will now turn the call over to Joe for more details on our clinical dev. efforts.
JOE SHAN (VP/Clin.&Reg. Affairs) – CLINICAL TRIALS:
As Steve has stated, we are very excited to have the opportunity for a late-breaking oral presentation on the Phase III SUNRISE trial at the ESMO Congress about a month from now [Oct7-11 http://www.esmo.org/Conferences/ESMO-2016-Congress ]. Even as the trial continues to wind down, treatment, follow-up, and data collection are still ongoing for a number of patients, with some continuing to receive bavituximab over a year. At ESMO, we will be presenting both topline clinical data from the trial as well as initial results from our ongoing biomarker analysis, the results of which have been promising to-date. Because these data have been accepted for presentation at ESMO, they are under embargo until the actual presentation, but we will provide addl. details on the ESMO presentation and our findings as soon as we can. As a reminder, the biomarker program was prospectively built into the SUNRISE protocol, and is designed to help us better understand how bavituximab works and which patients may benefit most. This is a massive effort, and though there are still much ongoing sample testing and data analysis, our goal is to share these results as they become available throughout the rest of this year and into 2017.
Now turning to our collaboration with the NCCN. Just a couple of days ago, NCCN announced the oncology research program had awarded grants to 3 investigators to support clinical trials of bavituximab in combination with other therapeutics [9-6-16: http://tinyurl.com/gutgwb5 ].
*One award is for Phase I trial of sorafenib [Bayer’s Nexavar] and bavituximab + radiation in Hepatocellular Carcinoma. This will build on a previously reported investigator sponsored Phase II trial of bavituximab & sorafenib in Liver Cancer. [3-25-15/Dr.Adam.Yopp(UTSW)/Ph2data, N=38: http://tinyurl.com/opkh5qy ]
*The 2nd award is for a Phase I/II trial of bavituximab with radiation + temozolomide [Merck’s Temodar] in newly diagnosed Glioblastoma. This trial is supported by some of our most impressive preclinical data demonstrating long-term survival in a lethal brain cancer model and that surviving rats were immune from tumor re-challenge.
*The 3rd award is for a Phase II study of pembrolizumab [Merck’s Keytruda, anti-PD-1] & bavituximab in Head & Neck Cancer. We are particularly excited about this project, as it will be the first clinical trial of bavituximab with a checkpoint inhibitor. In multiple previous preclin. studies, we have observed bavituximab's potential to work synergistically with PD1 inhibitors such as pembrolizumab.
These 3 studies align with our overall dev. strategy and will add to our knowledge about bavituximab-focused cancer treatment combinations. While we are not directly involved with these studies, we’ll be watching the progress carefully and look forward to providing an updates on the 3 NCCN trials in the coming months. That concludes my comments today. Let me now turn the call over to Rob Garnick, Head of Regulatory Affairs.
ROBERT GARNICK (Head of Reg. Affairs):
I’d like to emphasize the strategic importance of the biomarker study, which, as Joe said, was built into the SUNRISE trial. The identification of a positive biomarker or relevant biomarker pattern with clinical efficacy is an important facet of clinical trial design that can be used to inform addl. new studies that in turn might be used to select patients who would best benefit from bavituximab therapy. For example, the identification of the HER2 biomarker was critical in the development of Herceptin. Its importance was only critically established based on the results of a Phase II clinical trial. As Steve previously described, the critical role of the PD-L1 biomarker is emerging as a major factor in the selection of patients for the clinical use of Opdivo & Keytruda. In the case of bavituximab, once a promising biomarker or biomarker pattern is identified, we strategically plan to include these results into potential new clinical trials. I will now turn the call over to Jeff Hutchins, VP of Preclin. Research.
JEFF HUTCHINS (VP/PreClinical Res.)
I’d first like to provide an update on our PS Exosome Program. As we announced in July [7-14-16: http://tinyurl.com/zszd4fj ], we executed a licensing agreement with UT Southwestern Medical Center for a novel exosome technology designed to detect PS-positive exosomes in a patient blood sample. It is our belief that this technology can provide clinicians with detection & monitoring information regarding the presence and the prevalence of cancer. Preliminary indep. studies have demonstrated that the levels of PS-positive exosomes present in the blood of cancer patients are higher than levels found in the blood of healthy volunteers. Furthermore, study findings also suggest that there is a correlation between the level of PS positive exosomes detected in the blood of cancer patients and the severity and extent of their disease burden. Given our in-house expertise in PS targeting, we believe that we are uniquely qualified to advance this technology. We believe there are significant opportunities to use this technology as both a complementary tool in bavituximab's ongoing development as well as more broadly as the basis for a novel cancer detection and monitoring test kit that will be the focus of partnering efforts. It is our goal to develop, optimize and validate a functional screening assay capable of detecting PS positive exosomes in a blood sample and to initiate partnering discussions for commercialization of the program in 2017. We are on track to achieve this goal and we look forward to providing further updates.
I would now like to provide an update on Peregrine's preclinical I-O focused internal efforts and our collaboration with Memorial Sloan Kettering Cancer Center. The goal of this work is to evaluate combinations of PS targeting with other checkpoint inhibitors and immune stimulatory agents for the purpose of developing new and increasingly effective anticancer treatments. These programs are advancing well and to-date, we have seen impressive signs of activity with new combinations of PS targeting and other treatment modalities such as checkpoint blockers, T-cell agonists and radiation. These new combinations are improving overall survival accompanied with increases in cyto-reactive T cells into the tumor tissue. This exciting new internal work will be presented at the AACR/CRI Immunotherapy Meeting in New York later this month [Sept25-28: http://www.aacr.org/Meetings/Pages/MeetingDetail.aspx?EventItemID=101 ] and at ESMO in early October [Oct7-11: http://www.esmo.org/Conferences/ESMO-2016-Congress ]. We expect the first results from our collaboration with MSK’s Wolchok Lab investigators [See MSK Collab: http://tinyurl.com/zkvebh6 ] to be presented at SITC in November [Nov9-13: http://www.sitcancer.org/2016 ] and we will provide more detailed information as that presentation becomes available. That concludes my comments today. And I will turn the call over to Paul Lytle, CFO, who will discuss the company's financial performance including additional details regarding our Avid Bioservices business.
PAUL LYTLE (CFO):
Let me shift gears now and give you a brief overview of our financials. As a backdrop, our goal is to become profitable on an overall basis within the next 21 months, and we intend to reach this goal by growing revenue from our contract mfg. business while also reducing our R&D spending. Let me first talk about our contract mfg. business. During FY2016, our Avid business has experienced substantial revenue growth with a 5-year compounded annual growth rate of 39% and yr-over-yr growth of 66%. However, revenue for Q1 was lower than expected due to delays in 3rd-party testing labs that put revenue recognition for a number of mfg. runs from Q1 to Q2 of FY2017. As a result, contract mfg. revenue for Q1 was $5.6mm, compared to $9.4mm for the same qtr last year. However, as these revenues shift, we now expect to recognize revenue in excess of $20mm in Q2/FY2017. I would also like to reaffirm our full FY2017 revenue guidance of $50-55mm, representing up to 24% and yr-over-yr growth compared to last FY. And it's important to note that our projected revenue growth is supported by current revenue backlog of $71mm under signed contacts covering services to be completed during the remainder of FY17 and into FY18. Now given our corporate goal of reaching profitability in 21 months, it is critical that we continue to grow our contract mfg. business. For this reason and coupled with the high demand for mfg. services, we are planning to construct a 3rd mfg. facility focused on products in clinical development. We believe the 3rd facility will again significantly increase our mfg. capacity and all 3 mfg. facilities will have the potential to generate in total approx. $110mm in annual revenue. We expect the new facility to be complete and ready for clinical mfg. activities by mid calendar year 2017.
Shifting gears now to expenses, let me first discuss our R&D strategy. We are focusing our internal drug development efforts on small, cost effective, early stage clinical trials designed to attract potential partners to further advance our products. We believe this strategy will not only help us achieve profitability sooner, but it could also create significant potential upside for our shareholders. As we execute on this strategy, our R&D expenses decreased 38% this qtr compared to the same prior year qtr. And if you compare R&D expenses for the current qtr ended July to the last reported qtr ended April, we saw a 47% decrease in R&D expenses. This decrease in R&D was primarily driven by lower costs associated with our Phase III SUNRISE trial combined with a decrease in related payroll & mfg. costs. Turning to cost of contract mfg., we saw a decrease in mfg. costs during Q1 in relation to the similar decrease in revenue. For G&A expenses, we saw a slight increase in Q1 as compared to the same prior year qtr as we increased our infrastructure to support the expansion of our contract mfg. business. A more detailed analysis of our statement of operations is included in our Form 10-Q that was filed today [ http://tinyurl.com/jmy77g3 ]. This concludes our prepared remarks. We would now like to open the call up for questions.
Q&A: [beg. 19:30]
1. Joe Pantginis – Roth Capital Partners: [ http://www.roth.com & https://roth2.bluematrix.com/docs/pdf/BLUE.pdf ]
JP: ”With regard to your burn rate, how do you look at the burn with regard to R&D pgms vs. expanding Avid pgms vs. expanding clinical studies?”
Steve King: We’ve been trying to find and strike a balance between growing revenues and investments on the R&D side. I think that programs like the NCCN are good examples of how we can cost effectively run a number of studies in order to gather addl. clinical data. As we get more and more information from the SUNRISE study, particularly the biomarker analysis, and other bits of information that will help guide the program, then I think we’ll have to look at how we invest in addl. clinical studies, either in conjunction with some of our collaborators or as standalone company-sponsored clinical studies. Our goal right now is to still keep things in balance and to move towards profitability. We think there is a great upside on the Avid business. Even though revenues were down this qtr because of some delays in shipping out some products, that's really an anomaly. I think you’re going to see that we continue to grow the business throughout this FY, moving into next FY when we’ll bring online our new clinical facility. So that will add more on the revenue side and that helps offset any expenditures we have. Also one of our other major initiatives is to develop enough clinical data for bavituximab that we think can bring onboard a partner who can then really help fund the program going forward. We think we can do that very effectively through smaller studies, particularly biomarker driven studies, or at least studies in which biomarkers play a major role in helping select patients and [????] outcomes.
JP: ”How can you describe over the last few months or so how your interactions with AstraZeneca have been regarding bavituximab?”
Steve King: We continue to discuss the pathway forward. What we’re trying to do is learn as much as we can from SUNRISE, because it's a great opportunity and it’s not often you get a set of data this big in which we had already prospectively built in a lot of biomarker and other types of analysis into the study. And we actually think that the data, even though it’s a docetaxel study, those results will be actually critical in advancing this in I-O combinations in the future as well. And so, it’s just gathering data, discussing the data that's available, but more data is literally coming to light on almost daily basis, it seems. And that's going to continue for the next few months., so I would say “engaged”, and at this point we just need to really find the right balance when we have enough information to clearly define what we want to do going forward.
2. Kumar Raja - Noble Life Science Partners http://noblelsp.com/research
KR: ”For the 3 awards selected by the NCCN, what was the rationale for selecting those 3 different cancers, as well as the rationale for the combinations being selected there? And how much funding is remaining for further grants by NCCN?”
Steve King: I will start and then I turn it over to Joe. So basically the NCCN process, this is a more or less consortium of 27 top medical centers in the U.S. where clinical research is performed. The way it works is, it's a competitive process - any of the institutions or investigators at the institutions can basically submit their proposals. The background data is generally based on when it has been published or what has been presented at conferences, so that becomes some of the background information. But, the process itself is about the most interesting combinations, those that will take advantage of the novel I-O mechanism of action of bavituximab, and then also trials which have the highest probability of being operationalized and successful in a given amount of time. I will turn it over to Joe for maybe some more.
Joe Shan: As Steve mentioned, this is an independent process. They follow a process very similar to an NCI grant funding process, where they look at obviously what concepts have been submitted for consideration and rank those in order of importance, not just from a scientific curiosity standpoint, but a clinical capability and a medical need standpoint as well. So that's the general process. Why those 3 specifically, that was determined by the expert committee that was assigned for this project.
Steve King : I’m very excited about the combinations that were chosen because the radiation combination is one that in preclinical studies, as was mentioned during the prepared remarks, has always shown a lot of promise. It’s great to be able to now see that put into a clinical setting in a couple of different clinical trials. And the I-O combinations, as Jeff mentioned during his prepared remarks, is a major focus of ours. So to see a Pembro [Keytruda] combination picked as well, we are just really excited that these were the 3 winners out of the selection process.
KR: ”And you talked about profitability and using collaborations to develop the pipeline. What would be the strategy there for a collaboration? Would be like equal partnership, or would it be just like Peregrine keeping the U.S. rights and having collaboration for the Ex-US? What's the strategy there for those collaborations?”
Steve King : The collaborations could go on a number of different fronts. One would be true collaborations, like clinical collaborations we’ve put in place already. It could also be more partnerships, which I think is more what you are talking about, in which we have a development partner. We have flexibility in the overall design. Our goal is to keep significant upside of the program - I feel like we’ve added a lot of value to the program and now we want to see the benefit of that down the road. But at the same time, share the risk because we’ve shared all the risk up to this point ourselves. So, someone who could actually help drive the funding forward, because recognize that it’s not just going to be just one more study that should be run when it comes to late stage clinical development, but should be multiple studies, and our goal would be to find a partner who is going to run those not just on a ex-U.S. basis, but also on worldwide basis and to help us advance the program to commercialization.
KR: Re: the biomarker analysis. What are you seeing so far? And what can we expect to see presented at ESMO (Oct7-11)?”
Steve King : Right now all the data is embargoed per the acceptance by ESMO for the oral presentation. So we’re not going to give any details at this point. Some of the other factors are of course that for novel things, intellectual property considerations that we may want to obtain in the meantime before presentation are important. So at this point, we’re not going to give any more details other than, it’ll be a nice rounded set of information available at the ESMO presentation, and we’ll will PR that as well.
3. Thomas Yip (FBR & Co.): http://www.fbr.com
TY: ”Good to hear that Avid is doing well and you guys have continued with the clinical progress with bavituximab. Can you remind us how will the new Avid facility be reflected in the P&L?”
Paul Lytle : We recognized $44mm in revenues last FY (fye 4-30-16) and that all came from our original Franklin facility. In March this year, we commissioned our new Myford facility which is built for late stage Phase III clinical & commercial production, and we are currently going through the motions of multiple process validation runs and those runs right now are built into our financial projections of the $50-55mm, with our goal of turning those process validation runs, which is kind of the final step before submitting something to the FDA under preapproval inspection in terms of producing commercial quantities for those clients. So this year is really a building year in terms of building those process validation runs for our clients, and then we’re hopeful that those will turn into commercial supply needs in future FY’s.
TY: ”Will the cost of that new facility be under cost of contract manufacturing?”
Paul Lytle : Yes. It's built into the cost of goods, the facility overhead, including personnel and everything else.
TY: “Can you give us some more details about the testing backlog of that 3rd-party testing lab and what are the exact reasons and how likely it could happen in the future?”
Steve King : We think it's an anomaly and so we don't expect this to be an ongoing issue. The issue is basically, the testing labs were so busy, there was a backlog or line to get into the queue to actually get the testing completed. Of course, we can't release lots without all the testing results and we can't ship them until they are released, and that's the reason that it hit the bottom line this quarter. We think it’s an anomaly. It's nothing to do with testing results, per se, for the lots. it’s really just getting them in the line to get the testing done and that's the reason we are projecting that Q2 [q/e 10-31-16] will be such a big quarter, because now that backlog seems to have worked itself out and we’ve worked it into our planning to give ourselves a little bit more time. And so we think it's hopefully something that's behind us. Of course, we can't control all the 3rd-party laboratories, but we are certainly working directly with them as well to ensure that we are able to maintain a high priority for them because we do generate a significant amount of business for a lot of our vendors.
TY: ”Re: NCCN trials, from this point on, what addl. info or resources are required from your end?”
Steve King : Basically, that's one of the beauties of working with NCCN - they actually run the clinical studies themselves. So, they take care of all the database management, all the site visits, start up, all that stuff is handled through the consortium. For us at this point, it's just more being supportive of their efforts. One of the things that we would potentially want to help out on will be some of the biomarker-type testing, particularly as we learn more from the SUNRISE study, building those into some of the clinical trials as they make sense, so they can collect samples that can be tested and then we can add that to our database in conjunction with the rest of our biomarker testing plans. Other than that, our only other obligation is to provide bavituximab for the clinical trials, and as we have discussed before, we have a stockpile of that, so that's not really an issue at this point.
MR. KING’S CLOSING COMMENTS:
I want to thank all of you again for participating in today's phone call. As always, I want to thank our stockholders for their continued support and I would like to especially thank our patients, their families and the investigators that are participating in our bavituximab clinical trials. With that, we will conclude the call.
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9-8-15 PR: Peregrine Pharmaceuticals Reports Financial Results for First Quarter of Fiscal Year 2017 and Recent Developments
– SUNRISE Top-line Data Accepted for Late-Breaking Oral Presentation at European Society of Medical Oncology Congress in October 2016
-- Avid First Quarter Revenue of $5.6 Million with Over $20 Million in Revenue Projected in Second Quarter
-- Company Reaffirms Revenue Projection of $50-55 Million for Full FY 2017 with Growing Backlog of Business Currently at $71 Million
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=988439
TUSTIN, Sept. 8, 2016: Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company committed to improving patient lives by manufacturing high quality products for biotechnology and pharmaceutical companies and advancing its proprietary R&D pipeline, today announced financial results for the first quarter of fiscal year (FY) 2017 ended July 31, 2016, and provided an update on its contract manufacturing business, clinical pipeline and other corporate developments.
HIGHLIGHTS SINCE APRIL 30, 2016
"Since the start of our first quarter, we have steadily executed on our R&D and contract manufacturing objectives. On the R&D front, we recently achieved two important milestones beginning with the recent announcement [9-6-16: http://tinyurl.com/gutgwb5 ] that the National Comprehensive Cancer Network (NCCN) has awarded grants to three investigators to support bavituximab clinical research. In addition, we are pleased to announce today, that top-line data from our Phase III SUNRISE trial have been accepted for a late-breaking oral presentation at the upcoming meeting of the European Society of Medical Oncology (ESMO) Congress to be held in Copenhagen in early October," stated Steven W. King, President and CEO of Peregrine. "The presentation at ESMO [Oct7-11-16: http://www.esmo.org/Conferences/ESMO-2016-Congress ] will be a great opportunity to share clinical data from the trial in conjunction with initial results from our ongoing biomarker analyses which are already highly encouraging. The primary goal of the biomarker analysis is to identify a biomarker pattern for patients that receive the most benefit from a bavituximab-containing therapeutic regimen and we look forward to sharing the results of the ongoing analysis with more data expected later in the year. Our collaboration with the NCCN has been an important part of our plans for advancing the bavituximab clinical program in a cost effective way. The grants that were awarded represent clinical trials with novel bavituximab combinations in glioblastoma, head and neck cancer, and hepatocellular carcinoma including an immunotherapy combination, which is a major focus for advancing the program. Taken together, these developments are setting the stage for new data throughout the rest of 2016 and into 2017."
Mr. King continued, "On the manufacturing front, it remains an extraordinarily busy time. Based on the high demand for services, we remain on track to meet our current fiscal year revenue projections as we look to continue growing the business. Our ultimate goal remains to reach overall profitability within the next 21 months and Avid will be an important driver for achieving that goal in combination with making strategic investments in R&D while pursuing partnerships to help advance our programs."
AVID BIOSERVICES HIGHLIGHTS
"Our biomanufacturing business was extremely busy this past quarter as the team remained on track according to the planned production schedule including initiating several process validation runs and ongoing commercial manufacturing activities. Despite being on track from a production standpoint, first quarter FY 2017 revenues were lower than expected due to a testing backlog at a third-party testing laboratory that delayed the shipment of manufacturing runs. As a result of the backlog being resolved, we expect revenue to exceed $20 million in the second quarter as we shift revenue recognition from the first quarter to the second quarter of fiscal year 2017. We believe this delay to be an anomaly, and we reaffirm our revenue guidance of between $50 and $55 million for the full fiscal year," stated Paul Lytle, CFO of Peregrine.
The company is projecting manufacturing revenue for the full FY 2017 of $50-$55 million.
Avid's current manufacturing revenue backlog is $71 million, representing estimated future manufacturing revenue to be recognized under committed contracts. This backlog covers revenue to be recognized during the remainder of fiscal year 2017 and into fiscal year 2018.
In response to demand for manufacturing services, the company is designing a third manufacturing facility dedicated to clinical manufacturing that is anticipated to significantly increase Avid's manufacturing capacity. The new clinical suite is expected to be complete and ready for clinical manufacturing activities by mid calendar year 2017.
CLINICAL DEVELOPMENT HIGHLIGHTS
SUNRISE top-line data, including initial biomarker profile data, have been accepted for oral presentation at the European Society of Medical Oncology (ESMO) Congress in October 2016.
Peregrine's research collaboration with NCCN is advancing as planned, with grants awarded to 3 investigators to support research of bavituximab in combination with other therapeutics for the following studies:
1. Phase I Trial of Sorafenib and Bavituximab Plus Stereotactic Body Radiation Therapy (SBRT) for Unresectable Hepatitis C Associated Hepatocellular Carcinoma
2. Phase I/II Clinical Trial of Bavituximab with Radiation and Temozolomide for Patients with Newly Diagnosed Glioblastoma
3. Phase II Study of Pembrolizumab and Bavituximab for Progressive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
The company expects these trials to begin in early calendar year 2017.
RESEARCH HIGHLIGHTS
Our internal efforts and collaboration with Memorial Sloan Kettering Cancer Center continues to advance. The goal of this pre-clinical work is to evaluate combinations of bavituximab with other checkpoint inhibitors and immune stimulatory agents for the purpose of developing new and increasingly effective anti-cancer treatments. We expect initial results from our internal work and this collaboration to be presented at multiple conferences during the Fall of 2016.
Peregrine in-licensed a novel exosome technology from UT Southwestern [7-14-16: http://tinyurl.com/zszd4fj ] that has potential for cancer detection and monitoring applications. This technology aligns directly with the company's expertise, its proprietary PS-targeting platform and the bavituximab development program. As such, there are opportunities to use this technology as both a complementary tool in bavituximab's ongoing development, as well as more broadly as the basis for novel cancer detection and monitoring tests that can be the focus of partnering efforts.
FINANCIAL RESULTS
Total revenues for the first quarter of FY 2017 were $5,609,000, compared to $9,671,000 for the same quarter of the prior fiscal year. The first quarter FY 2017 decrease in revenues was primarily attributed to a decrease in contract manufacturing revenue.
Contract manufacturing revenue from Avid's clinical and commercial biomanufacturing services provided to its third-party clients decreased to $5,609,000 for the first quarter of FY 2017 compared to $9,379,000 for the first quarter of FY 2016. The first quarter decrease was primarily due to a backlog at a third-party testing lab and unrelated to product quality that shifted the timing of revenue recognition from the first quarter to the second quarter of fiscal year 2017. The company does not expect this delay to further impact revenue projections for the fiscal year, and the company remains on track to generate revenue in excess of $20 million in the second quarter FY 2017.
Total costs and expenses for the first quarter of FY 2017 were $16,691,000, compared to $23,425,000 for the first quarter of FY 2016. This decrease for the first quarter of FY 2017 was primarily attributable to a decrease in research and development expenses associated with the Phase III SUNRISE trial combined with a decrease in personnel cost and manufacturing costs related to preparing bavituximab for commercial manufacturing.
For the first quarter of FY 2017, research and development expenses decreased 38% to $8,569,000, compared to $13,918,000 for the first quarter of FY 2016. In addition, cost of contract manufacturing decreased to $3,062,000 in the first quarter of FY 2017 compared to $4,608,000 for the first quarter of FY 2016, primarily due to lower reported revenue compared to the same prior year period. For the first quarter of FY 2017, selling, general and administrative expenses were $5,060,000 compared to $4,899,000 for the first quarter of FY 2016.
Peregrine's consolidated net loss attributable to common stockholders was $12,437,000 or $0.05 per share, for the first quarter of FY 2017, compared to a net loss attributable to common stockholders of $15,101,000, or $0.08 per share, for the same prior year quarter.
Peregrine reported $44,195,000 in cash and cash equivalents as of July 31, 2016, compared to $61,412,000 at fiscal year ended April 30, 2016.
More detailed financial information and analysis may be found in Peregrine's Annual Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today. [ http://tinyurl.com/jmy77g3 ]
CONFERENCE CALL
Peregrine will host a conference call and webcast this afternoon, September 8, 2016, at 4:30 PM EDT (1:30 PM PDT). To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Peregrine Pharmaceuticals conference call. To listen to the live webcast, or access the archived webcast, please visit: http://ir.peregrineinc.com/events.cfm .
ABOUT PEREGRINE PHARMACEUTICALS, INC.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of patients by delivering high quality pharmaceutical products through its contract development and manufacturing organization (CDMO) services and through advancing and licensing its investigational immunotherapy and related products. Peregrine's in-house CDMO services, including cGMP manufacturing and development capabilities, are provided through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and biomanufacturing services for both Peregrine and third-party customers. The company is also working to evaluate its lead immunotherapy candidate, bavituximab, in combination with immune stimulating therapies for the treatment of various cancers, and developing its proprietary exosome technology for the detection and monitoring of cancer. For more information, please visit http://www.peregrineinc.com .
ABOUT AVID BIOSERVICES
Avid Bioservices provides a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With over 15 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, Avid's services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support. The company also provides a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. For more information about Avid, please visit http://www.avidbio.com .
Safe Harbor *snip*
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
THREE MONTHS ENDED
JULY 31,
2016 2015
REVENUES :
Contract manufacturing revenue $ 5,609,000 $ 9,379,000
License revenue — 292,000
Total revenues 5,609,000 9,671,000
COSTS AND EXPENSES:
Cost of contract manufacturing 3,062,000 4,608,000
Research and development 8,569,000 13,918,000
Selling, general and administrative 5,060,000 4,899,000
Total costs and expenses 16,691,000 23,425,000
LOSS FROM OPERATIONS (11,082,000 ) (13,754,000 )
Interest and other income 25,000 31,000
NET LOSS $ (11,057,000 ) $ (13,723,000 )
Comprehensive loss $ (11,057,000 ) $ (13,723,000 )
Series E preferred stock accumulated dividends (1,380,000 ) (1,378,000 )
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS $ (12,437,000 ) $ (15,101,000 )
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING
Basic and diluted 239,595,089 197,317,374
BASIC AND DILUTED LOSS PER COMMON SHARE $ (0.05 ) $ (0.08 )
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
JULY 31,
2016 APRIL 30,
2016
Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 44,195,000 $ 61,412,000
Trade and other receivables 7,537,000 2,859,000
Inventories 25,274,000 16,186,000
Prepaid expenses and other current assets 1,235,000 1,351,000
Total current assets 78,241,000 81,808,000
Property and equipment, net 24,261,000 24,302,000
Restricted cash 600,000 600,000
Other assets 2,502,000 2,333,000
TOTAL ASSETS $ 105,604,000 $ 109,043,000
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 9,095,000 $ 8,429,000
Accrued clinical trial and related fees 6,577,000 7,594,000
Accrued payroll and related costs 3,653,000 5,821,000
Deferred revenue 21,531,000 10,030,000
Customer deposits 21,731,000 24,212,000
Other current liabilities 669,000 1,488,000
Total current liabilities 63,256,000 57,574,000
Deferred rent, less current portion 1,414,000 1,395,000
Commitments and contingencies
STOCKHOLDERS' EQUITY:
Preferred stock - $0.001 par value; authorized 5,000,000 shares;
1,577,440 and 1,577,440 issued and outstanding at July 31, 2016
and April 30, 2016, respectively 2,000 2,000
Common stock - $0.001 par value; authorized 500,000,000 shares;
241,456,721 and 236,930,485 issued and outstanding at July 31,
2016 and April 30, 2016, respectively 241,000 237,000
Additional paid-in capital 561,024,000 559,111,000
Accumulated deficit (520,333,000 ) (509,276,000 )
Total stockholders' equity 40,934,000 50,074,000
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 105,604,000 $ 109,043,000
CONTACTS:
• Jay Carlson Peregrine Pharmaceuticals, Inc. 800-987-8256 info@peregrineinc.com
• Stephanie Diaz (Investors) Vida Strategic Partners 415-675-7401 sdiaz@vidasp.com
• Tim Brons (Media) Vida Strategic Partners 415-675-7402 tbrons@vidasp.com
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[From 10-Q header: “As of Sept. 2 2016, there were 242,381,850 shares outstanding.”
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Latest 10K 4-30-16 iss. 7-14-16 http://tinyurl.com/zgognwz PR: http://tinyurl.com/h8eqtg5 (Cash 4-30-16=$61.4mm)
Latest 10Q 7-31-16 iss. 9-8-16 http://tinyurl.com/jmy77g3 PR: http://tinyurl.com/jydtkoy (Cash 7-31-16=$44.2mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
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FY'17/Q1(qe 7-310-16) PR: The company is projecting mfg. revenue for the full FY’17 of $50-55mm. Avid's current backlog is $71mm (committed contracts). In response to demand for mfg. services, the company is designing a 3rd mfg. Facility dedicated to clinical mfg. that is anticipated to significantly increase Avid's mfg. capacity. The new clinical suite is expected to be complete & ready for clinical mfg. activities by mid 2017.
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Updated PPHM REVS-BY-QTR TABLE, now thru FY17'Q1(qe 7-31-16), per the 7-31-16 10-Q ( http://tinyurl.com/jmy77g3 ) issued 9-8-16.
• Total Revs since May’06: ($179.2mm/Avid + $24.1mm/Govt + $2.5mm/Lic.) = $205.8mm
• 9-8-16: FY'17 (May'16-Apr'17) Avid revs guidance $50-55mm (Committed B/L=$71mm).
• Deferred-Revs at 7-31-16 total $21.5mm, UP from $10.0mm at 4-30-16.
• Cust.Deposits at 7-31-16 total $21.7mm, DOWN from $24.2mm at 4-30-16.
• Inventories at 7-31-16 total $25.3mm, UP from $16.2mm at 4-30-16.
• Avid’s Gross-Profit over last 4 qtrs: $19.2mm on revs of $40.6mm (GP%=47%)
• Recall, Avid Rev$ 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$ GP%
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%
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%
FY15Q1 7-31-14 5,496,000 3,583,000 1,913,000 35%
FY15Q2 10-31-14 6,263,000 4,139,000 2,124,000 34%
FY15Q3 1-31-15 5,677,000 3,113,000 2,564,000 45%
FY15Q4 4-30-15 9,308,000 4,758,000 4,550,000 49%
FY16Q1 7-31-15 9,379,000 4,608,000 4,771,000 51%
FY16Q2 10-31-15 9,523,000 4,741,000 4,782,000 50%
FY16Q3 1-31-16 6,672,000 3,896,000 2,776,000 42%
FY16Q4 4-30-16 18,783,000 9,721,000 9,062,000 48%
FY17Q1 7-31-16 5,609,000 3,062,000 2,547,000 45%
FY13 TOTAL: 21,333,000 12,595,000 8,738,000 41%*
FY14 TOTAL: 22,294,000 13,110,000 9,184,000 41%*
FY15 TOTAL: 26,744,000 15,393,000 11,151,000 42%*
FY16 TOTAL: 44,357,000 22,966,000 21,391,000 48%*
*Avid Net-Profit (ie, incl. Selling, G&A) not split out from PPHM-Corp. in the financials.
.
PPHM REVENUES (in thousands) DEFERRED
-------REVENUES------- REVENUES INVEN-
Quarter Avid Govt Lic. TOTAL Avid Govt TORIES
FY07Q1 7-31-06 398 0 23 421 317 0 971
FY07Q2 10-31-06 636 0 48 684 1388 0 1899
FY07Q3 1-31-07 347 0 16 363 2202 0 1325
FY07Q4 4-30-07 2111 0 129 2240 1060 0 1916
FY08Q1 7-31-07 1621 0 4 1625 1820 0 2363
FY08Q2 10-31-07 1863 0 29 1892 1338 0 3500
FY08Q3 1-31-08 1662 0 13 1675 1434 0 2394
FY08Q4 4-30-08 751 0 150 901 2196 0 2900
FY09Q1 7-31-08 1193 324 0 1517 4021 980 4628
FY09Q2 10-31-08 983 958 0 1941 6472 1701 6700
FY09Q3 1-31-09 5778 1048 0 6826 4805 3262 5547
FY09Q4 4-30-09 5009 2683 175 7867 3776 3871 4707
FY10Q1 7-31-09 2070 4671 9 6750 5755 2332 6177
FY10Q2 10-31-09 5308 1510 78 6896 4260 3989 5850
FY10Q3 1-31-10 2945 6854 78 9877 3052 76 3861
FY10Q4 4-30-10 2881 1461 78 4420 2406 78 3123
FY11Q1 7-31-10 983 2111 115 3209 3719 47 4692
FY11Q2 10-31-10 3627 966 78 4671 2447 35 3555
FY11Q3 1-31-11 1922 882 79 2883 4300 40 3915
FY11Q4 4-30-11 1970 681 78 2729 5617 0 5284
FY12Q1 7-31-11 5439 0 216 5655 4145 0 4481
FY12Q2 10-31-11 4154 0 78 4232 2012 0 3178
FY12Q3 1-31-12 3203 0 78 3281 2552 0 2722
FY12Q4 4-30-12 1987 0 78 2065 3651 0 3611
FY13Q1 7-31-12 4135 0 116 4251 6056 0 5744
FY13Q2 10-31-12 6061 0 78 6139 6221 0 5426
FY13Q3 1-31-13 6961 0 78 7039 5061 0 4635
FY13Q4 4-30-13 4176 0 78 4254 4171 0 4339
FY14Q1 7-31-13 4581 0 107 4688 4164 0 5679
FY14Q2 10-31-13 7354 0 0 7354 3468 0 4033
FY14Q3 1-31-14 3885 0 0 3885 4329 0 5224
FY14Q4 4-30-14 6474 0 0 6474 5241 0 5530
FY15Q1 7-31-14 5496 0 0 5496 4670 0 5998
FY15Q2 10-31-14 6263 0 37 6300 3612 0 5379
FY15Q3 1-31-15 5677 0 0 5677 5752 0 6148
FY15Q4 4-30-15 9308 0 0 9308 6630 0 6148
FY16Q1 7-31-15 9379 0 292 9671 8291 0 10457
FY16Q2 10-31-15 9523 0 0 9523 9688 0 12554
FY16Q3 1-31-16 6672 0 37 6709 15418 0 15189
FY16Q4 4-30-16 18783 0 0 18783 15418 0 15189
FY17Q1 7-31-16 5609 0 0 5609 21531 0 25274
Totals: 179178 24149 2453 205780 <=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
FY15 4-30-15 26,781 …Avid(CMO)= 26,744
FY16 4-30-16 44,686 …Avid(CMO)= 44,357
...Total Gov’t Revs from 7-2008 inception thru FY11Q1(Apr’11): $24.15mm
.
PPHM’S QTLY. NET LOSS BY QTR:
FY08Q1 7-31-07 4,656,000
FY08Q2 10-31-07 6,207,000
FY08Q3 1-31-08 6,154,000
FY08Q4 4-30-08 6,159,000
FY09Q1 7-31-08 5,086,000
FY09Q2 10-31-08 4,497,000
FY09Q3 1-31-09 3,332,000
FY09Q4 4-30-09 3,609,000
FY10Q1 7-31-09 2,428,000
FY10Q2 10-31-09 2,787,000
FY10Q3 1-31-10 1,538,000
FY10Q4 4-30-10 7,741,000
FY11Q1 7-31-10 7,695,000
FY11Q2 10-31-10 7,513,000
FY11Q3 1-31-11 8,929,000
FY11Q4 4-30-11 10,014,000
FY12Q1 7-31-11 8,092,000
FY12Q2 10-31-11 12,055,000
FY12Q3 1-31-12 11,090,000
FY12Q4 4-30-12 10,882,000
FY13Q1 7-31-12 7,664,000
FY13Q2 10-31-12 8,753,000
FY13Q3 1-31-13 4,914,000
FY13Q4 4-30-13 8,449,000
FY14Q1 7-31-13 7,600,000
FY14Q2 10-31-13 7,790,000
FY14Q3 1-31-14 9,724,000
FY14Q4 4-30-14 10,248,000
FY15Q1 7-31-14 13,129,000
FY15Q2 10-31-14 12,100,000
FY15Q3 1-31-15 12,994,000
FY15Q4 4-30-15 12,135,000
FY16Q1 7-31-15 13,723,000
FY16Q2 10-31-15 13,198,000
FY16Q3 1-31-16 16,847,000
FY16Q4 4-30-16 11,884,000
FY17Q1 7-31-16 11,057,000
= = = = = = = =
OPER. CASH BURNS* BY QTR(FROM THE 10-Q/K’S):
FY10Q1 7-31-09 2,024,000 (from 10Q pg.25)
FY10Q2 10-31-09 2,351,000 (Q1+Q2: 4,375,000 pg.28)
FY10Q3 1-31-10 1,158,000 (Q1+Q2+Q3: 5,533,000 pg.30)
FY10Q4 4-30-10 6,375,000 (FY’10: 11,908,000 10K pg.58)
FY11Q1 7-31-10 6,567,000 (from 10Q pg.24)
FY11Q2 10-31-10 6,167,000 (Q1+Q2: $12,734,000 pg.25)
FY11Q3 1-31-11 7,736,000 (Q1+Q2+Q3: $20,470,000 pg.26)
FY11Q4 4-30-11 8,961,000 (FY’11: 29,431,000 10K pg.54)
FY12Q1 7-31-11 6,984,000 (from 10Q pg.25)
FY12Q2 10-31-11 11,668,000 (Q1+Q2: 18,652,000 pg.25)
FY12Q3 1-31-12 8,490,000 (Q1+Q2+Q3: 27,142,000 pg.25)
FY12Q4 4-30-12 11,265,000 (FY’12: 38,407,000 10K pg.55)
FY13Q1 7-31-12 6,742,000 (from 10Q pg.21)
FY13Q2 10-31-12 6,162,000 (Q1+Q2: 12,904,000 pg.23)
FY13Q3 1-31-13 3,597,000 (Q1+Q2+Q3: 16,501,000 pg.23)
FY13Q4 4-30-13 7,053,000 (FY’13: 23,554,000 10K pg.60)
FY14Q1 7-31-13 5,750,000 (from 10Q pg.23)
FY14Q2 10-31-13 5,834,000 (Q1+Q2: 11,584,000 10Q pg.24)
FY14Q3 1-31-14 7,875,000 (Q1+Q2+Q3: 19,459,000 10Q pg.26)
FY14Q4 4-30-14 8,706,000 (FY’14: 28,165,000 10K pg.55)
FY15Q1 7-31-14 11,076,000 (from 10Q pg.23)
FY15Q2 10-31-14 9,947,000 (Q1+Q2: 21,023,000 10Q pg.25)
FY15Q3 1-31-15 11,116,000 (Q1+Q2+Q3: 32,139,000 10Q pg.26)
FY15Q4 4-30-15 10,474,000 (FY’15: 42,613,000 10K pg.54)
FY16Q1 7-31-15 12,306,000 (from 10Q pg.25)
FY16Q2 10-31-15 11,701,000 (Q1+Q2: 24,007,000 10Q pg.26)
FY16Q3 1-31-16 15,086,000 (Q1+Q2+Q3: 39,093,000 10Q pg.27)
FY16Q4 4-30-16 10,112,000 (FY'16: 49,205,000 10K pg.39)
FY17Q1 7-31-16 9,607,000 (from 10Q pg.22)
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
FY’15 total Op-Burn: $42,613,000
FY’16 total Op-Burn: $49,205,000
Period Halozyme Cust-A Other-Custs
FYE 4-30-14 91% 1% 8%
FYE 4-30-15 79% 12% 9%
FYE 4-30-16 69% 26% 5%
Q/E 7-31-16 65% 29% 6%
ATM Sales Summary (3/2009–9/8/2016). Also, PPHM O/S Shares History Table (’06–curr.) at the bottom of this post. At 9-2-16, common shares O/S = 242,381,850sh.
**There were NO ATM SALES from 7-15-16 – CURRENT(9-8-16).
**During 8/1/16-9/8/16, 68,910sh. of PREFERRED/10.5%SeriesE were sold for gross=$1,601,000 ($9,134,000 remain available).
ATM = “At-The-Market Sales Issuance”
I. WM-SMITH 3-2009:
• $7.5mm ATM/Wm.SMITH 3-26-09: $7,500,000gr. / 2,150,759sh. = $3.49/sh. (commiss: 3%)
• $25mm ATM/Wm.SMITH 7-14-09: $25,000,000gr. / 7,569,314sh. = $3.30/sh. (commiss: 3%/1st$15mm, then 2%)
*Total Raised via WmSmith ATM Sales thru 7-31-10:
. . . . $32,500,000gr. / 9,720,073sh. = $3.34/sh.
II. MLV 6-2010: http://www.mlvco.com
$15mm ATM/MLV 6-22-10 (commiss: 2%) Form424: http://tinyurl.com/24txkxb
• Sold 6/22/10–10/31/10: $6,840,000gr. / 4,031,018sh. = $1.70/sh.
• Sold 11/1/10–11/30/10: $7,407,000gr. / 4,711,611sh. = $1.57/sh.
• Sold 12/1/10–1/31/11: $753,000gr. / 471,744sh. = $1.60/sh.
*Total Raised via MLV June’10 ATM Sales thru 1-31-11:
. . . . $15,000,000gr. / 9,214,373 = $1.63/sh.
III. MLV 12-2010: “Dec’10 AMI Agreement” http://www.mlvco.com
$75mm ATM/MLV 12-29-10 (commiss: max=5%) Form8K: http://tinyurl.com/2a6w76g
(pursuant to $75mm S-3 Shelf Reg. filed 12-17-10: http://tinyurl.com/2469b2d )
• Sold 12/29/10-1/31/11: $6,460,000gr. / 2,385,862sh. = $2.71/sh.
• Sold 2/1/11-2/28/11: $2,358,000gr. / 998,142sh. = $2.36/sh.
• Sold 3/1/11-4/30/11: $4,470,000gr. / 1,840,487sh. = $2.43/sh.
• Sold 5/1/11-7/31/11: $3,713,000gr. / 1,912,576sh. = $1.94/sh.
• Sold 8/1/11-10/31/11: $5,582,000gr. / 4,727,840sh. = $1.18/sh.
• Sold 9-2-12 Roth Direct: $6,940,000gr./ 6,252,252sh. = $1.11/sh.
• Sold 11/1/11-1/31/12: $10,961,000gr. / 10,308,025sh. = $1.06/sh.
• Sold 2/1/12-2/29/12: $5,871,000gr. / 5,726,946sh. = $1.03/sh.
• Sold 3/1/12-4/30/12: $1,263,000gr. / 2,198,543sh. = $.57/sh.
• Sold 5/1/12-6/30/12: $1,496,000gr. / 2,752,691sh. = $.54/sh.
• Sold 7/1/12-9/26/12: none**
• Sold 9/27/12-10/31/12: $16,719,000gr./ 18,557,928 = $.90/sh.
• Sold 11/1/12-11/30/12: $7,296,000gr./ 9,220,313 = $.79
• Sold 12/1/12-1/31/13: $1,540,000gr./ 1,131,282 = $1.36
• Sold 2/1/13-3/12/13: $330,000gr./ 201,154 = $1.64
*Total Raised via MLV Dec’10 ATM Sales thru 3-12-2013:
. . . . $75,000,000gr. / 68,214,041 = $1.10sh.
IV. MLV 12-2012: “Dec’12 AMI Agreement” http://www.mlvco.com
$75mm ATM/MLV 12-29-12 (commiss: max=5%) Form8K: http://tinyurl.com/2a6w76g
(pursuant to $75mm S-3 Shelf Reg. filed 3-9-12: http://tinyurl.com/7dl7pjm )
• Sold 2/1/13-3/12/13: $4,475,000gr. / 3,132,402sh. = $1.43/sh.
• Sold 3/13/13-4/30/13: $8,897,000gr. / 6,188,273sh. = $1.44/sh.
• Sold 5/1/13-7/11/13: $12,729,000gr. / 7,927,016sh. = $1.61/sh.
• Sold 7/12/13-7/31/13: $2,468,000gr. / 1,690,864sh. = $1.46/sh.
• Sold 8/1/13-9/9/13: $4,372,000gr. / 3,057,431sh. = $1.43/sh.
• Sold 9/10/13-10/31/13: $4,708,000gr. / 3,262,958sh. = $1.44/sh.
• Sold 11/1/13-12/6/13: NONE – see 10Q note below.
• Sold 12/7/13-1/31/14: $28,130,000gr. / 16,045,717sh. = $1.75/sh.
• Sold 2/1/14-4/30/14: $3,017,000gr. / 1,543,383sh. = $1.95/sh.
• Sold 5/1/14-7/31/14: $425,000gr. / 226,700sh. = $1.92/sh.
• Sold 8/1/14-10/31/14: $3,891,000gr. / 2,494,835sh. = $1.56/sh.
• Sold 11/1/14-1/31/15: $1,878,000gr. / 1,261,825sh. = $1.49/sh.
*Total Raised via MLV Dec’12 ATM Sales thru 10-31-2014:
. . . . $75,000,000gr. / 46,831,404 = $1.60sh.
V. MLV 6-2014: “Jun’14 AMI Agreement – up to $25mm” http://www.mlvco.com
• Sold 11/1/14-1/31/15: $1,193,000gr. / 869,504sh. = $1.43/sh.
• Sold 2/1/15-3/12/15: $6,204,000gr. / 4,354,954sh. = $1.44/sh.
• Sold 3/13/15-4/30/15: $6,147,000gr. / 4,457,299sh. = $1.38/sh.
• Sold 5/1/15-7/14/15: $8,896,000gr. / 6,534,400sh. = $1.36/sh.
• Sold 7/15/15-7/31/15: $1,270,000gr. / 1,003,830sh. = $1.27/sh.
• Sold 8/1/15-9/9/15: $1,290,000gr. / 1,091,508sh. = $1.18/sh.
*Total Raised via MLV Jun’14 ATM Sales thru 9-9-2015:
. . . . $25,000,000gr. / 18,311,495 = $1.37/sh.
VI. MLV 8-2015: “Aug’15 AMI Agreement – up to $30mm” http://www.mlvco.com
• Sold 8/7/15-9/9/15: $892,000gr. / 1,091,000sh. = $1.18/sh.
• Sold 9/10/15-10/31/15: $4,294,000gr. / 4,059,478sh. = $1.06/sh.
• Sold 11/1/15-12/10/15: $2,261,000gr. / 1,939,413sh. = $1.17/sh.
• Sold 12/11/15-1/31/16: *NO ATM SALES*, per 1-31-16 10Q iss. 3-9-16
• Sold 2/2/16-4/30/16: *NO ATM SALES*, per 4-30-16 10Q iss. 7-14-16
• Sold 5/1/16-7/14/16: $937,000gr. / 1,876,918sh. = $.50/sh.
• Sold 7/15/16-9/8/16: *NO ATM SALES*, per 7-31-16 10Q iss. 9-8-16
. . . . $8,384,000gr. / 8,628,569 = $.97/sh.
VII. NOBLE 8-2015: “Aug’15 Eq.Dist. Agreement – up to $20mm” http://www.noblelsp.com
• Sold 11/1/15-12/10/16: $2,371,000gr. / 1,925,844sh. = $1.23/sh.
• Sold 12/11/15-1/31/16: $2,857,000gr. / 2,529,434sh. = $1.13/sh.
• Sold 2/1/16-4/30/16: $1,741,000gr. / 4,017,010sh. = $.43/sh.
• Sold 5/1/16-7/14/16: $1,233,000gr. / 2,649,318sh. = $.47/sh.
• Sold 7/15/16-9/8/16: *NO ATM SALES*, per 7-31-16 10Q iss. 9-8-16
. . . . $8,202,000gr. / 11,121,606 = $.74/sh. '
TOTAL ALL A-T-M SALES – INCEPTION (3-2009) THRU 9-9-2015:
==> $239,085,000gr. / 172,041,561sh. = $1.39/sh.
- - - - - - - - - -
10-31-11 10Q: “During the 6mos. 10-31-11, we sold 6,440,416 shares of our common stock at mkt-prices for gross proceeds of $9,295,000 under the Dec’10 AMI Agreement before deducting commissions and other issuance costs of $260,000”
1-31-12 10Q: “During the 9mos. ended 1-31-12, we sold 16,948,441 shares of our common stock at mkt-prices for gross proceeds of $20,256,000 under the Dec’10 AMI Agreement before deducting commissions and other issuance costs of $482,000. …During Feb.2012, we sold an addl. 5,726,946 shares of common stock at market prices under the Dec’10 AMI Agreement in exchange for aggregate gross proceeds of $5,871,000. As of 2-29-12, gross proceeds of $38,644,000 remained available under our 2 effective shelf registration statements.”
4-30-12 10K: “Under the Dec. 2010 AMI Agreement with MLV …for aggregate gross proceeds of up to $75,000,000… During FY’s 2011 (5’10-4’11) and 2012 (5’11-4’12), we sold 30,098,421 shares of common stock at market prices under the Dec.2010 AMI for aggregate gross proceeds of $40,678,000 before deducting commissions & other issuance costs of $917,000. As of April 30, 2012, aggregate gross proceeds of up to $27,382,000 remained available under the Dec.2010 AMI… Subsequent to April 30, 2012 and through June 30, 2012, we sold 2,752,691 shares of common stock at mkt prices under the Dec.2010 AMI for aggregate gross proceeds of $1,496,000… Under the registered direct public offering dated Sept. 2, 2011, we entered into separate subscription agreements with 3 institutional investors, pursuant to which we sold an aggregate of 6,252,252 shares of our common stock at a purchase price of $1.11/sh. for gross proceeds of $6,940,000 before deducting placement agent fees and other offering expenses of $525,000.”
10-31-12 10Q: “During the 6mos. 10-31-12, we sold 21,310,619 shares… at varying mkt-prices under the Dec’10 AMI Agreement for gross proceeds of $18,215,000 before deducting commissions and other issuance costs of $620,000. From 11-1-12 thru 11-30-12, we sold 9,220,313 shares gross of $7,296,000. As of 11-30-12, aggregate gross proceeds of up to $1,871,000 remained available under the Dec’10 AMI Agreement. As of 11-30-12, gross proceeds of $151,871,000 remained available under 2 effective shelf registration statements.”
1-31-13 10Q/pg.11: “DEC’10-AMI(max=$75mm): During the 9 mos. ended 1-31-13, we sold 31,662,214 shares at varying mkt-prices for gross proceeds of $27,051,000 before deducting commissions/other-costs of $885,000. As of 1-31-13, gross proceeds of up to $330,000 remained available. From 2-1-13 – 3-12-13, we sold 201,154 shares at mkt prices for gross $330,000. As of 3-12-13, we had raised the full amt of gross proceeds available… DEC’12-AMI(max=$75mm): As of 1-31-13, we had not sold any shares. From 2-1-13 - 3-12-13, we sold 3,132,402 shares at mkt prices for gross proceeds of $4,475,000. As of 3-12-13, gross proceeds of up to $70,525,000 remained available.”
4-30-13 10K/pg.F26: Dec’12-AMI(max=$75mm)Agreement – During FY’13, we sold 9,320,675 shares gross proceeds of $13,372,000 before deducting commissions and other issuance costs of $337,000. As of April 30, 2013, gross proceeds of up to $61,628,000 remained available under the Dec’12-AMI. From 5/1/13 – 7/11/13, we sold 7,927,016 shares for gross proceeds of $12,729,000. As of 7-11-13, gross proceeds of $48,899,000 remained available under the Dec’12-AMI. http://tinyurl.com/p58jcbw
7-31-13 10Q/pg.10: During the 3mos ended 7-31-13, we sold 9,617,880 shares at mkt prices under the Dec’12 AMI Agreement for gross proceeds of $15,197,000 before deducting commissions and other issuance costs of $491,000. As of July 31, 2013, gross proceeds of up to $46,431,000 remained available under the Dec’12-AMI. From 8-1-13 – 9-9-13, we sold 3,057,431 shares for gross proceeds of $4,372,000. As of 9-9-13, gross proceeds of $42,059,000 remained available under the Dec’12-AMI.
10-31-13 10Q/pg.10: During the 6mos ended 10-31-13, we sold 15,938,269 at mkt prices under the Dec’12 AMI for gross proceeds of $24,277,000 before deducting costs of $722,000. As of 10-31-13, aggregate gross proceeds of up to $37,351,000 remained available under the Dec’12 AMI.
***NOTE: There is no stmt in the 10-Q regarding AMI Sales subsequent to 10-31-13 (thru 12-6-13) as has been the case in the 10Q’s for years – the assumption being: NO AMI Sales made 11/1/13-12/6/13, a period where O/S shares only went up by 77,149.
1-31-14 10Q/pg.11: During the 9 mos. ended 1-31-14, we sold 31,983,986 shares under the Dec’12/AMI for gross $52,407,000 before deducting commissions & other iss. costs of $1,427,000. As of 1-31-14, gross proceeds of up to $9,221,000 remained available under the Dec’12/AMI. http://tinyurl.com/pxcjocw
4-30-14 10K pg.F25: “During FY14, we sold 33,527,369 shares under the Dec’12/AMI for gross proceeds of $55,424,000 before deducting commissions & other iss. costs of $1,504,000. As of April 30, 2014, aggregate gross proceeds of up to $6,204,000 remained available under the December 2012 AMI Agreement.” http://tinyurl.com/mhva3k3
7-31-14 10Q/Pg5: During the 3mos. ended 7-31-14, we raised $10,000,000 in aggregate gross proceeds from the sale of our 10.50% SeriesE Convertible Preferred Stock under an At Market Issuance Sales Agreement. Pg.11: During the 3mos. ended 7-31-14, we sold 226,700sh. under the Dec’12-2012 AMI Agreement for gross of $435,000 before deducting commissions & other costs of $14,000. As of 7-31-14, gross of up to $5,769,000 remained available under the Dec’12-2012/AMI. On 6-13-14, we entered into an At Market Issuance Sales Agreement (“June2014/AMI”), with MLV, pursuant to which we may sell shares of our common stock through MLV, for aggregate gross proceeds of up to $25,000,000, in registered transactions from our shelf registration statement on Form S-3. As of 7-31-14, we had not sold any shares of common stock under the June 2014 AMI Agreement. http://tinyurl.com/phw6dkp
10-31-14 10Q/Pg12: COMMON: During 6mos. ended 10-31-14, we sold 2,721,535 sh. at mkt prices under the Dec’12-AMI for gross proceeds of $4,326,000 before deducting commissions and other issuance costs of $113,000. As of 12-31-14, gross proceeds of up to $1,878,000 remained available under the Dec’12-AMI. PREFERRED: During 6mos. ended 10-31-14, we sold 402,858 sh. at mkt prices gross proceeds of $10,070,000 before deducting commission and other issuance costs of $552,000. As of 10-31-14, gross proceeds of up to $19,930,000 remained available under the Series E AMI Agreement. http://tinyurl.com/m6ldhg7
1-31-15 10Q/Pg12: COMMON: During the 9mos. ended 1-31-15, we sold 3,983,360 sh. at mkt prices under the Dec’12-AMI for gross proceeds of $6,204,000 before deducting commissions and other issuance costs of $162,000. As of 1-31-15, we had raised the full-amt of gross proceeds available to us under the Dec’12-AMI. PREFERRED:
Jun’14-AMI: On 6-13-14, we entered into an AMI with MLV…up to $25mm… ,000,000, in registered transactions from our shelf registration statement on Form S-3 (File No. 333-180028). During the 9mos. ended 1-31-15, we sold 869,504 sh. at mkt prices under the Jun’14-AMI for gross of $1,193,000 before deducting commissions and other issuance costs of $31,000. As of 1-31-15, gross proceeds of up to $23,807,000 remained available. Subsequent to 1-15-15 and thru 3-12-15, we sold 4,354,954 sh. of common at mkt prices under the Jun’14-AMI for gross of $6,204,000. As of 3-12-15, 2015, gross proceeds of $17,603,000 remained available under the Jun’14-AMI.
PREFERRED: During the 9mos. ended 1-31-15, we sold 405,004 sh. of our Series E Preferred Stock at mkt prices under the Series E AMI Agreement for gross proceeds of $10,121,000 before deducting commission and other issuance costs of $553,000. As of 1-31-15, 2015, gross proceeds of up to $19,879,000 remained available under the Series E AMI. http://tinyurl.com/mwedt8w
4-30-15 10K pg.F25: During FY’15 we sold 9,681,757sh. under the June’14/AMI for $13,544,000, before deducting costs of $352,000. As of 4-30-15, $11,456,000 remained available. Pg.F35: Subsequent to 4-30-15 & thru 7-14-15, we sold 6,534,400sh. for $8,896,000. A/o 7-14-15, $2,560,000 remain. http://tinyurl.com/ocrtkuj
7-31-15 10Q/Pg12+18: During the 3mos ended 7-31-15, we sold 7,538,230sh. Under the JUNE2014 AMI for gross of $10,166,000 before deducting commiss/iss-costs of $275,000. As of 7-31-15, gross of $1,290,000 remained available under the JUNE2014 AMI, as amended. JUNE2014 AMI: subsequent to 7-31-15 and thru 9-9-15, we sold 1,091,508sh. gross of $1,290,000. As of 9-9-15, 2015, we had raised the full amount available under the June2014 AMI. AUG2015 AMI: on 8-7-15, we entered into an At Market Issuance Sales Agreement with MLV, for gross proceeds of up to $30,000,000, 2.5% commission; as of 9-9-15, we sold 752,760sh. under the AUG2015 AMI for gross of $892,000. http://tinyurl.com/pemub47
10-31-15 10Q/Pg13+19: During 6mos ended 10-31-15, we sold 4,812,238sh at mkt prices under MLV AUG2015 AMI for gross=$5,186,000 before deducting commiss/costs of $132,000. As of 10-31-15, gross proceeds of up to $24,814,000 remained available. Subsequent to 10-31-15, thru 12-10-15, we sold 1,939,413sh for gross=$2,261,000. As of 12-10-15, $22,553,000 remained.
On 8-7-15, we entered into an “Equity Distribution Agreement” with Noble Life Science Partners, pursuant to which we may sell shares for gross proceeds of up to $20,000,000 (commission=2.5% of gross). As of 10-31-15, we had not sold any shares… Subsequent to 10-31-15 & thru 12-10-15, we sold 1,925,844 shs. at mkt prices for gross=$2,371,000. As of 12-10-15, gross of up to $17,629,000 remained available.
On 10-30-15, we entered into a Common Stock Pur. Agreement with EASTERN CAPITAL Ltd: sold 18,518,518shs @1.08/sh for gross=$20,000,000 before deducting issuance costs of $1,000.
10Q: http://tinyurl.com/zdbo9rv [10-30-15: Kenneth Dart (Eastern Capital) acquires 13.1% stake (30,106,945sh.) in PPHM http://tinyurl.com/24qctos ]
1-31-16 10Q/Pg13: During 9mos ended 1-31-16, we sold 6,751,651sh at mkt prices under MLV AUG2015 AMI for gross=$7,447,000 before commiss/costs =$190,000. As of 1-31-16, gross of $22,553,000 remained available. Subsequent to 10-31-15 thru 12-10-15, we sold 1,939,413sh for gross=$2,261,000. As of 12-10-15, $22,553,000 remained.
NOBLE Eq-Dist-AMI: during 9mos. ended 1-31-16, we sold 4,455,278shs. for gross of $5,228,000, commissions=$131,000. As of 1-31-16, $14,772,000 remained… http://tinyurl.com/hdgto9y
4-30-16 10K pg.F24+25: NOBLE Eq-Dist-AMI - FY’16 sales: 8,472,288sh. For gross=$6,969,000. As of 4-30-16, gross remaining=$13,031,000. Pg.F35/SUBSEQUENT EVENTS: NOBLE/EQ 5/1/16-7/14/16, sold 2,649,318sh. for gross=$1,232,000, a/o 7-14-16, $11,799,000 remain available. MLV AUG2015 AMI: 5/1/16-7/14/16, sold 1,876,918sh. for gross=$937,000, a/o 7-14-16, $21,616,000 remain available. 10K: http://tinyurl.com/zgognwz
7-31-16 10Q p.12: NOBLE Eq-Dist-AMI: 5/1/16-7/31/16, sold 2,649,318sh. for gross=$1,233,000, a/o 7-31-16, $ 11,798,000 remain available. MLV AUG2015 AMI: 5/1/16-7/31/16, sold 1,876,918sh. for gross=$937,000, a/o 7-31-16, $21,616,000 remain available. Pg16/SUBSEQUENT: PREFERRED/SeriesE: 8/1/16-9/8/16, we sold 68,910sh. for gross=$1,601,000; a/o 9-8-16, $9,134,000 remained available. 10Q: http://tinyurl.com/jmy77g3
PREFERRED SHARES:
4-30-15 10K/p.F26: On 6-13-14, we entered into an At Market Issuance Sales Agreement with MLV, pursuant to which we may issue & sell shares of our Series E Preferred Stock through MLV, as agent, for gross proceeds of up to $30,000,000, in registered transactions from our Jan2014 Shelf. During FY’2015, we sold 799,764 shares of our Series E Preferred Stock at mkt prices for gross $19,205,000 before deducting commissions/costs of $1,002,000. As of 4-30-15, gross proceeds of up to $10,795,000 remained available under the Series E AMI Agreement.
NOTE: One of the holders of Preferred is KENNETH DART (EASTERN CAPITAL), who in a 2-13-15 SG14G ( http://tinyurl.com/k4nsfuu ) reported their 240,000sh. Preferred holdings as 2,000,000 common shares (SHARED VOTING POWER: 9,921,760,% OF CLASS REPRESENTED: 5.4%).
“which has a liquidation preference of $25.00/sh. and a conversion price of $3.00/sh.” 2,000,000 / 240,000 = 8.333
**7-31-16 10Q(iss. 9-8-16): 8/1/16-9/8/16, we sold 68,910sh. for gross=$1,601,000; a/o 9-8-16, $9,134,000 remained available.
- - - - - - - - - - - - - - - - -
Latest 10K 4-30-16 iss. 7-14-16 http://tinyurl.com/zgognwz PR: http://tinyurl.com/h8eqtg5 (Cash 4-30-16=$61.4mm)
Latest 10Q 7-31-16 iss. 9-8-16 http://tinyurl.com/jmy77g3 PR: http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=988439 (Cash 7-31-16=$44.2mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
- - - - - - - - - - - - - - - - - -
PPHM’S ATM PHILOSOPHY, CFO PAUL LYTLE, 12-9-10 CC:
“Beyond these 2 sources of capital ([Avid & Gov’t], we have raised addl. capital through the equity markets and it’s important to note that over the past 3 years we have sold every share at market prices [“ATM”], without warrants, without discounts. We continue to be active in the investment community and we have had strong interest from institutional investors intrigued by our clinical data, by our multiple trials to evaluate Bavituximab’s broad therapeutic potential, and by the interim survival data we have seen from our novel brain cancer therapy Cotara. Our goal is to maintain a balanced financial approach with multiple sources of capital and to carefully manage our cash burn as we continue to advance these programs.” http://tinyurl.com/24xmcsn
= = = = = = = = = = = = = = = = = =
PPHM - O/S Shares History (’06–curr.)
4-30-06 35,876,438
1-31-07 39,222,440
4-30-07 39,222,440
7-6-07 45,233,123
7-31-07 45,242,123
10-31-07 45,242,123
1-31-08 45,242,123
4-30-08 45,242,123
7-31-08 45,242,123
10-31-08 45,242,123
1-31-09 45,242,123
4-30-09 45,537,711
7-10-09 47,392,883
7-31-09 47,393,783
10-31-09 48,869,563 +1,475,780
1-31-10 50,903,404 +2,033,841
4-30-10 53,094,894 +2,191,490
6-21-10 54,388,917 +1,294,023 (6-22-10 ATM/mlv Form424)
7-9-10 55,069,449 +475,987 (4-30-10 10K iss. 7-14-10)
7-31-10 55,784,955 +715,506
10-31-10 59,220,742 +3,435,787
11-30-10 63,932,353 +4,711,611 (10-31-10 10Q iss. 12-9-10)
12-15-10 64,404,097 +471,744 (12-17-10 S-3: $75M Shelf Reg.)
1-31-11 66,813,419 +2,409,322
2-28-11 67,885,811 +1,072,392 (1-31-11 10Q iss. 3-11-11)
4-30-11 69,837,142 +1,951,331
7-8-11 71,069,858 +1,232,716 (4-30-11 10K iss. 7-14-11)
8-22-11 72,704,647 +1,634,789 (Proxy iss. 8-26-11)
8-31-11 73,284,016 +579,369 (424B5 iss. 9-2-11)
9-8-11 79,536,268 +6,252,252 (Roth Sale to 3 Inst’s @ $1.11/sh.)
10-31-11 82,638,201 +3,101,933
12-9-11 86,788,817 +4,150,616 (10-31-11 10Q iss. 12-12-11)
1-31-12 93,146,226 +6,357,409
2-29-12 98,873,172 +5,726,946 (1-31-12 10Q iss. 3-9-12)
4-30-12 101,421,365 +2,548,193
7-13-12 104,174,056 +2,752,691 (4-30-12 10K iss. 7-16-12)
7-31-12 104,178,431 +4,375 (7-31-12 10Q iss. 9-10-12)
8-16-12 104,191,176 +12,745 (prelim. proxy 14A http://tinyurl.com/c48bvof )
9-7-12 104,191,176 nochg (7-31-12 10Q iss. 9-10-12)
10-31-12 123,310,188 +19,119,012
12-7-12 132,539,783 +9,229,595 (10-31-12 10Q iss. 12-10-12)
1-31-13 133,770,614 +1,230,831
3-12-13 137,110,758 +3,340,144 (1-31-13 10Q iss. 3-12-13)
4-30-13 143,768,946 +6,658,188 (4-30-13 10K iss. 7-11-13)
7-5-13 151,602,765 +7,833,819 (4-30-13 10K iss. 7-11-13)
7-31-13 153,506,811 +1,904,046
9-5-13 156,461,114 +2,954,303 (7-31-13 10K iss. 9-9-13)
10-31-13 160,248,742 +3,781,628
12-6-13 160,325,891 +77,149 (10-31-13 10K iss. 12-10-13)
1-31-14 176,453,261 +16,127,370
3-3-14 176,481,054 +27,793 (1-31-14 10Q iss. 3-7-14)
4-30-14: 178,871,164 +2,390,110
7-7-14: 179,209,458 +338,294 (4-30-14 10-K cover page, iss. 7-14-14)
7-31-14: 179,216,032 +6,574 (7-31-14 10Q iss. 9-9-14)
8-22-14: 179,226,424 +10,392 (8-28-14 Proxy/Def14A)
9-5-14: 179,505,424 +279,000 (7-31-14 10Q iss. 9-9-14)
10-31-14: 182,000,583 +2,495,159 (10-31-14 10Q iss. 12-10-14)
12-5-14: 182,081,234 +80,651 (10-31-14 10Q cover pg., iss. 12-10-14)
12-19-14: 182,081,234 -0- (12-23-14 S-3)
1-31-15: 184,244,698 +2,163,464 (1-31-15 10Q iss. 3-12-15)
3-12-15: 188,332,872 +4,088,174 (“ “ “)
4-30-15: 193,346,627 +5,013,755 (4-30-15 10-K iss. 7-14-15)
7-10-15: 199,934,918 +6,588,291 (4-30-15 10-K/cover-pg, iss. 7-14-15)
7-31-15: 200,983,948 +1,049,030 (7-31-15 10Q iss. 9-9-15)
9-4-15: 202,124,031 +1,140,083 (“ “ “)
10-31-15: 225,824,551 +23,700,520 (10-31-15 10Q iss. 12-10-15)<=Incl. 18.5mm sh. Dart/EastCAP @1.08
12-9-15: 229,701,808 +3,877,257 (10-31-15 10Q iss. 12-10-15)
1-31-16: 232,231,242 +2,529,434 (1-31-16 10Q iss. 3-9-16)
3-8-16: 233,738,426 +1,507,184 (“ “ “)
4-30-16: 236,930,485 +3,192,059 (4-30-16 10K iss. 7-14-16)
7-11-16: 241,456,721 +4,526,236 (“ “ “)
7-31-16: 241,456,721 -0- (7-31-16 10Q iss. 9-8-16)
9-2-16: 242,381,850 +925,129 (“ “ “)
O/S WARRANTS & STOCK-OPTIONS A/O 7-31-2016 (10Q pg.14):
• WARRANTS: As of 7-31-2016, warrants to purchase 273,280 shares at an exercise price of $2.47 were outstanding and are exercisable through Aug30 2018. These warrants were issued in FY’13 in connection with the Aug.2012 [Oxford] loan agreement, which was paid in full Sept.2012.
• STOCK OPTIONS OUTSTANDING A/O 7-31-2016: 29,923,770 shares at a wgt.avg. exercise price of $1.27.
9-6-16: NCCN to Init. 3 Bavi-Trials Early’17 (Moffitt,MassGEN,JohnHopkins)
=> Ph1/HepC-Related-Hepatocellular/MOFFITT, Ph1-2/Glioblastoma/MASS-GEN, Ph2/Head+Neck/JOHN-HOPKINS
9-6-16: National Comprehensive Cancer Network (NCCN) Awards 3 Grants for Combination Studies of Peregrine Pharmaceuticals' Bavituximab in Multiple Cancers
Peregrine's Novel PS-Targeting Immuno-Oncology (I-O) Agent to be Combined with Immunotherapy and Traditional Cancer Treatments in Studies Focused on Glioblastoma, Head and Neck Cancer and Hepatocellular Carcinoma
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=987864
TUSTIN, Sept. 6, 2016: Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company committed to improving patient lives by manufacturing high quality products for biotechnology and pharmaceutical companies and advancing its proprietary R&D pipeline, today announced that the National Comprehensive Cancer Network (NCCN®) Oncology Research Program (ORP) has awarded 3 grants to investigators to support research of bavituximab in combination with other therapeutics for the treatment of Glioblastoma, Head & Neck Cancer, and Hepatocellular Carcinoma.
NCCN, a not-for-profit alliance of 27 of the world's leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Funding for the three investigator-initiated clinical studies will take place through a $2 million research grant made by Peregrine to NCCN's ORP. NCCN will be responsible for oversight and monitoring of the clinical studies through the research grant. It is expected that the selected trials will be initiated in early 2017.
"NCCN is excited to initiate three studies by accomplished investigators at NCCN Member Institutions that will explore the effect of this novel immunotherapy in three different cancers with significant unmet need," said Robert C. Young, MD, Interim VP, NCCN ORP.
The following NCCN-affiliated researchers were recipients of the grant awards:
1. Jessica Frakes, MD, Moffitt Cancer Center, "A Phase I Trial of Sorafenib and Bavituximab Plus Stereotactic Body Radiation Therapy (SBRT) for Unresectable Hepatitis C Associated Hepatocellular Carcinoma"
2. Elizabeth Gerstner, MD, Massachusetts General Hospital Cancer Center, "Phase I/II Clinical Trial of Bavituximab with Radiation and Temozolomide for Patients with Newly Diagnosed Glioblastoma"
3. Ranee Mehra, MD, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, "Phase II Study of Pembrolizumab & Bavituximab for Progressive Recurrent/Metastatic Squamous Cell Carcinoma of the Head & Neck"
"Our collaboration with NCCN provides the unique opportunity to support the group's highly-regarded research institutions and advance our understanding of the potential role of bavituximab in the treatment of various cancers. With this in mind, we were very pleased by the level of interest shown in bavituximab from the NCCN community and are grateful to all those who submitted their projects for rigorous evaluation by the ORP scientific review committee," said Joseph Shan, MPH, VP, Clinical & Regulatory Affairs of Peregrine. "We'd like to extend our congratulations to the 3 investigators who were selected for their unique and innovative concepts. These studies align with our development strategy for bavituximab which is currently focused on small, early stage clinical trials evaluating the drug in combination with other cancer treatments. Collaborators such as NCCN play a central role in this strategy and we look forward to integrating the valuable clinical data generated by these investigators to expand our knowledge regarding bavituximab-focused cancer treatment combinations."
Bavituximab is an investigational chimeric monoclonal antibody that targets phosphatidylserine (PS). Signals from PS inhibit the ability of immune cells to recognize and fight tumors. Bavituximab is believed to override PS mediated immunosuppressive signaling by blocking the engagement of PS with its receptors as well as by sending an alternate immune activating signal. PS targeting antibodies have been shown to shift the functions of immune cells in tumors, resulting in multiple signs of immune activation and anti-tumor immune responses.
ABOUT PEREGRINE PHARMACEUTICALS, INC.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of patients by delivering high quality pharmaceutical products through its contract development and manufacturing organization (CDMO) services and through advancing and licensing its investigational immunotherapy and related products. Peregrine's in-house CDMO services, including cGMP manufacturing and development capabilities, are provided 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. The company is also working to evaluate its lead immunotherapy candidate, bavituximab, in combination with immune stimulating therapies for the treatment of various cancers, and developing its proprietary exosome technology for the detection and monitoring of cancer. For more information, please visit http://www.peregrineinc.com .
ABOUT THE NATIONAL COMPREHENSIVE CANCER NETWORK
The National Comprehensive Cancer Network® (NCCN®), a not-for-profit alliance of 27 of the world's leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers.
The NCCN Member Institutions are: Fred & Pamela Buffett Cancer Center, Omaha, NE; Case Comprehensive Cancer Center/University Hospitals Seidman Cancer Center and Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; City of Hope Comprehensive Cancer Center, Los Angeles, CA; Dana-Farber/Brigham and Women's Cancer Center | Massachusetts General Hospital Cancer Center, Boston, MA; Duke Cancer Institute, Durham, NC; Fox Chase Cancer Center, Philadelphia, PA; Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT; Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, WA; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL; Mayo Clinic Cancer Center, Phoenix/Scottsdale, AZ, Jacksonville, FL, and Rochester, MN; Memorial Sloan Kettering Cancer Center, New York, NY; Moffitt Cancer Center, Tampa, FL; The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute, Columbus, OH; Roswell Park Cancer Institute, Buffalo, NY; Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, MO; St. Jude Children's Research Hospital/The University of Tennessee Health Science Center, Memphis, TN ; Stanford Cancer Institute, Stanford, CA; University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL; UC San Diego Moores Cancer Center, La Jolla, CA; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; University of Colorado Cancer Center, Aurora, CO; University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; The University of Texas MD Anderson Cancer Center, Houston, TX; University of Wisconsin Carbone Cancer Center, Madison, WI; Vanderbilt-Ingram Cancer Center, Nashville, TN; and Yale Cancer Center/Smilow Cancer Hospital, New Haven, CT.
Clinicians, visit http://NCCN.org . Patients and caregivers, visit http://NCCN.org/patients . Media, visit http://NCCN.org/news .
Safe Harbor *snip*
Contacts:
Jay Carlson, Peregrine Pharmaceuticals, Inc., (800) 987-8256, info@peregrineinc.com
Stephanie Diaz (Investors), Vida Strategic Partners, 415-675-7401, sdiaz@vidasp.com
Tim Brons (Media), Vida Strategic Partners, 415-675-7402, tbrons@vidasp.com
= = = = = = = = =
1-6-16: Peregrine enters into Research Collab. with Natl-Comprehensive-Cancer-Network (NCCN) http://tinyurl.com/zmxtpsb
...$2mm res. grant to NCCN's Oncology Res. Pgm (ORP), will “significantly expand our clinical evaluation of Bavi and augment Peregrine's IST pgm at 26 of the world's leading cancer centers”.
3-9-16 Qtly. Conf. Call (King/Shan/Worsley/Lytle) Transcript http://tinyurl.com/gom7md5
...CEO SK: “Peregrine remains a strong company with a valuable clinical asset and a rapidly growing biomanufacturing business... We believe our relationships with AstraZeneca, Mem. Sloan Kettering, UTSW, & NCCN will be invaluable as we establish & execute our overall strategy for advancing the bavituximab I-O combination plans in a range of cancers.”
CEO Steve King 9-22-16 Panelist in Berlin w/BMS/Merck/Agenus at Phacilitate’s “Immunotherapy Europe (Strategic Partnering Event)”...
Sept21-22 2016: “Phacilitate’s Immunotherapy Europe (Strategic Partnering Event)” Berlin, GER
“The Perfect Combination of Strategy & Innovation - Advancing immuno-oncology business & R&D models at Europe’s inaugural strategic partnering event. Delivering combination therapy, biomarkers, imaging, pricing & reimbursement, R&D and supply chain models to ensure next-generation immuno-oncology success.”
http://www.cgteurope.com/page.cfm/action=Seminar/libID=1/libEntryID=47
**PHACILITATE is a specialist in the organization of exclusive events for leaders from the pharma & biotech communities. Our philosophy is simple - to deliver the ultimate in strategic knowledge exchange & networking through flawless, personalized service.
9-22-16 9:50-10:20am WEBINAR:
“Analyzing The Business & Partnering Model In Industry & Academia For The Future Development Of Immuno-Oncology Combination Therapies”
Panelists/Speakers:
* Donnie McGrath - VP, Head Search & Evaluation, BusDev, Bristol-Myers Squibb
* Emmett Schmidt = Exec.Dir., Clinical Research, Merck Sharp & Dohme
* Jennifer Buell VP, Development Operations, Agenus
* Steven King – Pres. & CEO, Peregrine Pharmaceuticals - http://www.cgteurope.com/page.cfm/Action=Visitor/VisitorID=139
.
Kennedy Capital Mgt: “at prices we believe don’t adequately reflect the potential value creation”
NEW 6-30-16: KENNEDY CAPITAL MANAGEMENT, INC. +7,598,378 sh.
http://www.nasdaq.com/symbol/pphm/institutional-holdings
Kennedy Capital Mgt: Disciplined Process - “We work to identify companies that are able to reinvest in their business at attractive rates of return, and invest in those companies at prices we believe don’t adequately reflect the potential value creation from those investments.” http://www.kennedycapital.com/philosophy-process/
7-14-16/PR: Peregrine Licenses Exosome-Based Cancer Detection/Monitoring from UTSW. “The new technology licensed by Peregrine relates to assays that are able to detect small amounts of PS+ Exosomes in a patient blood sample as a way to potentially detect cancer at a very early stage of development.”'
[See: http://www.exosome-rna.com “NEWS”]
...See May'14 J.Immunol.Methods article (below) by Alan Schroit/Philip Thorpe, "A Novel 'Salting-Out' Procedure For The Isolation Of Tumor-Derived Exosomes”
...Also, see U.S./Intl. Patent App's 20150241431/WO2015131153, filed 2-27-15 - at bottom of this post (”Methods & Compositions For Isolating Exosomes”)…
7-14-16: Peregrine Licenses Novel Exosome-Based Cancer Detection and Monitoring Technology from UT Southwestern Medical Center
--New Technology Efficiently Builds on the Company's Existing Phosphatidylserine (PS) Targeting Platform and Assay Development Capabilities
--Stand Alone Program That Offers Significant Value Creation Potential and Early Partnering Opportunities
--New Technology to Also be Evaluated in Conjunction with Ongoing Bavituximab Clinical Development Program
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=979554
TUSTIN, July 14, 2016: Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM/PPHMP), a biopharmaceutical company committed to improving patient lives by delivering high quality biological products through its contract development and manufacturing organization (CDMO) services and by advancing its novel R&D pipeline, today announced that the company has entered into an exclusive licensing agreement with University of Texas (UT) Southwestern Medical Center for a novel exosome technology that has potential application as a simple blood test to detect or monitor cancer. The company intends to develop a novel cancer test utilizing internal expertise and then pursue revenue-generating partnering opportunities at an early stage of development.
Tumor exosomes represent small pieces of tumor cells that are released into the blood as tumors grow. Tumor derived exosomes have phosphatidylserine (PS) on their surface as a detectable marker. It is believed that even small tumors begin to release PS-positive exosomes and thus the ability to detect these exosomes in the blood may be an indicator of the presence of a tumor.
The licensing agreement is the result of the long-standing sponsored research agreement between Peregrine and UT Southwestern focused on PS, a highly immunosuppressive signaling molecule. The new technology licensed by Peregrine relates to assays that are able to detect small amounts of PS-exosomes in a patient blood sample as a way to potentially detect cancer at a very early stage of development. Preliminary studies have demonstrated that the levels of PS-positive exosomes present in the blood of cancer patients are higher than levels found in the blood of healthy volunteers. Furthermore, study findings also suggest that there is a correlation between the level of PS-positive exosomes detected in the blood of cancer patients and disease burden.
"We are excited to enter into this licensing agreement with our long-term collaborators at UT Southwestern. This technology offers a promising product development opportunity and aligns directly with the company's expertise with our proprietary PS-targeting platform and our longstanding CDMO capabilities around the development, qualification, and validation of in vitro analytical assays. As such, there are significant opportunities to use this technology as both a complementary tool in bavituximab's ongoing development, as well as more broadly as the basis for novel cancer detection and monitoring tests that can be the focus of partnering efforts," said Jeff T. Hutchins, Ph.D., Peregrine's VP, Preclinical Research. "It is important to note that this development program will require minimal capital investment and has the potential to create significant value over the next 18 months, including potential partnering opportunities. As a result, we feel that today's licensing deal provides yet another important driver in our ongoing efforts to achieve profitability."
Together, the Peregrine and Avid Bioservices teams have the existing infrastructure, staff and expertise to develop, optimize and validate a functional assay capable of detecting PS-positive exosomes from a blood sample. Given the company's extensive experience in developing assays of this type, Peregrine does not anticipate the need to add personnel or any specialized equipment for this project. The company intends to establish clinical proof-of-concept for the test and expects to initiate partnering discussions for the program in 2017.
"One of the most exciting aspects of this technology is the potential synergy that it offers with our ongoing bavituximab clinical development program. Through our ongoing work with bavituximab, we have gained significant understanding of PS-mediated immunosuppression in cancer," said Joseph Shan, MPH, VP, Clinical & Regulatory Affairs of Peregrine. "The availability of a PS-specific biomarker which can be implemented in our planned future bavituximab clinical trials aligns nicely with our refocused bavituximab development strategy aimed at generating the most meaningful data possible from small, early stage clinical trials to support partnering efforts."
ABOUT PEREGRINE PHARMACEUTICALS, INC.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of patients by delivering high quality pharmaceutical products through its contract development and manufacturing organization (CDMO) services and through advancing and licensing its investigational immunotherapy and related products. Peregrine's in-house CDMO services, including cGMP manufacturing and development capabilities, are provided 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. The company is also working to evaluate its lead immunotherapy candidate, bavituximab, in combination with immune stimulating therapies for the treatment of various cancers, and developing its proprietary exosome technology for the detection and monitoring of cancer. For more information, please visit http://www.peregrineinc.com .
Contacts: Jay Carlson Peregrine Pharmaceuticals, Inc. (800) 987-8256 info@peregrineinc.com
Stephanie Diaz (Investors) Vida Strategic Partners 415-675-7401 sdiaz@vidasp.com
Tim Brons (Media) Vida Strategic Partners 415-675-7402 tbrons@vidasp.com
= = = = = = = = http://www.ncbi.nlm.nih.gov/pubmed/24735771
J Immunol Methods, May 2014 Epub 4-13-14.
“A Novel 'Salting-Out' Procedure For The Isolation Of Tumor-Derived Exosomes”
Zachary Brownlee, Kristi D. Lynn, Philip E. Thorpe PE, Alan J. Schroit [PhD, PPHM SAB http://tinyurl.com/hnvps2l ]
Simmons Comprehensive CC, Dept of Immunology, UTSW-MC/Dallas
ABSTRACT:
The last decade has seen an exponential growth in the number of exosome-related publications. Although many of these studies have used exosomes from biological fluids (blood, and ascites or pleural effusions) the vast majority employed vesicles isolated from large volumes of tissue culture supernatants. While several techniques are available for their isolation, all require a significant reduction in volume to obtain sufficient concentrations for study. One approach is to concentrate the medium before proceeding with their isolation, however, these procedures are very time consuming and require specialized laboratory equipment. Here we provide a new and effective method for the isolation of tumor-derived exosomes based on "charge neutralization" with acetate. We show that titration of tissue culture supernatants with 0.1M acetate to pH4.75 results in immediate precipitation of virtually all the exosomes. The precipitated exosomes can be washed to remove residual media and are readily "resolubilized" upon resuspension in acetate-free buffer at neutral pH. This simple cost effective method significantly increases the yield of exosomes from an unlimited quantity of culture supernatants. Exosomes isolated by this technique are indistinguishable from exosomes recovered by direct ultracentrifugation.
ACKS: This work was supported by the Simmons Cancer Center Support Grant (5P30 CA142543-03) and by a sponsored research agreement with PEREGRINE PHARMACEUTICALS.
FULL ARTICLE: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4077054
= = = = =
U.S. Patent App# 20150241431 - Filed 2-27-15, Pub. 8-27-15
”Methods & Compositions For Isolating Exosomes”
USPO: http://tinyurl.com/hlcxb7f
Applicants: BOARD OF REGENTS, THE UNIV. OF TEXAS SYSTEM; PEREGRINE PHARMACEUTICALS, INC.
Inventors: SCHROIT, Alan, J.; THORPE, Philip, E.; Fussey; Shelley P.M.
Abstract: Disclosed are surprising new methods & compositions for isolating extracellular microvesicles such as exosomes, particularly disease-related and phosphatidylserine (PS)-positive extracellular microvesicles as exemplified by tumor- and viral-derived exosomes. The methods of the invention are rapid, efficient, cost-effective and, importantly, are suitable for use with large volumes of biological fluids and produce antigenically intact extracellular microvesicles and exosomes. The methods and compositions are based on the surprising use of acetate buffers to isolate large quantities of extracellular microvesicles, particularly tumor-derived exosomes, from solution, without damaging their morphological or functional properties or antigenicity.
- - - - - -
INTL. PATENT APP# WO/2015/131153, Filed 2-27-15, Pub. 3-9-15
”Methods & Compositions For Isolating Exosomes”
https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2015131153
= = = = = = http://www.exosome-rna.com (also: https://www.facebook.com/ExosomeRNA )
“Exosome-RNA.com is a place to find the latest research & industry news and information about exosome RNA. Exosomes are cell-derived vesicles that are present in many and perhaps all biological fluids, including blood, urine, and cultured medium of cell cultures. Exosomes contain various molecular constituents of their cell of origin, including proteins and RNA. It is becoming increasingly clear that exosomes have specialized functions and play a key role in, for example, coagulation, intercellular signaling, and waste management.”
Jeff Hutchins(VP/PreClin.Res) 9-13-16 at NEO-SYNTH's Lung Cancer Summit in Boston.
Sept13-14 2016: “NEO-SYNTH's Precision: Lung Cancer - World R&D Summit”, Boston
“Precision: Lung Cancer will bring together scientists & business leaders from pharma, biotech and academia, using extensive networking sessions to forge meaningful collaborations.”
http://precisionlungcancer.com
NEO-SYNTH: “Connecting The Pharma Industry By Forging Interactions” http://neo-synth.com
Agenda 9-13-16: http://precisionlungcancer.com/agenda--day-one.html
Agenda 9-14-16: http://precisionlungcancer.com/agenda--day-two.html
9-13-16 4:30pm: Speaker: Jeff Hutchins (VP/Prelin.Res., Peregrine), “Overriding Immune Suppression and Increasing TILs Through Blockade of the Phosphatidylserine Signaling Pathway”
= = = = = =
BAVI MOA 5-11-16 Breast Cancer Res. article, B.Freimark/CW.Hughes-et-al, “PS-Targeting/Bavi Combo w/Anti-PD1/PDL1 in Triple.Neg-MBC” http://tinyurl.com/zxu882y
...”our observations demonstrate that including PS-targeting antibodies such as bavituximab can enhance the anti-tumor activity of anti-PD-1/PD-L1 treatments, not only by increasing TIL responses but also by inhibiting cytokines stimulated by single-agent anti-PD-1 therapy that serve to suppress the immune response & promote tumor progression.”
BAVI MOA 4-20-16/AACR'16 & 4-4-16/Cancer-Immunology-Res.(AACR) article - preclin. data: Bavi combo w/anti-PD-1/anti-CTLA-4 “induces a shift in tumor microenvironment from immunosuppressive to immune active” http://tinyurl.com/jyox458
BAVI MOA 1-18-16: CEO Steve King explains PPHM's direct PS-Targeting advantage vs. the “individual-receptors” PS-binding approach of others like: Axl Mer TIM-3 RAGE Tyro3 GAS6 CD300a BAI1 MFG-E8 etc. http://tinyurl.com/h2h87mc
2-2016: Rutgers' Dr. Raymond Birge's relationship with Peregrine & UTSW's Dr. Rolf Brekken and his 2-26-16 article, “Phosphatidylserine is a Global Immunosuppressive Signal in Efferocytosis, Infectious Disease, and Cancer” http://tinyurl.com/z5d9qt9
11-9-15 SITC'15: New Bavi+Checkpoint Inhibitors preclin. data (UTSW/DUKE's Herbert K. Lyerly) http://tinyurl.com/pbof95w
...Also, collab. with Dr. Bernard Fox (Immunotherapist/Earle A. Chiles Res.Inst.) on new Immuno-Profiling Clinical Test (Opal 6-plex quantitative IF Assay), PPHM roundtable with Raymond Birge (Rutgers), Douglas Graham (Emory), Dmitry Gabrilovich (Wistar), Rolf Brekken (UTSW), Maria Karasarides (AstraZeneca) - ”Combining Bavi w/anti-PD-1 significantly enhanced O/S… significant incr. CD45+, CD8+ and CD3+ T-cells… led a prolonged anti-tumor immune response which protected the animals against a re-challenge w/same tumor.”
BAVI MOA 8-26-15: Jeff Hutchins(VP/PreClin-Res) ImVacS’15 Talk – 29pg. Slideshow http://tinyurl.com/qz64pzg
…“Expansion & Activation of T Cells via the Targeting of the Immunosuppressive Ligand PS: Combination Strategy with Conventional, Targeted, and Checkpoint Inhibitor Therapy”
5-31-15: ASCO’15 Roundtable (webcast), “Raising the Immuno-Oncology Bar” - 7 panel members, incl. 3 Sloan Kettering researchers http://tinyurl.com/qxu4w2x
7-27-16 Shaul/Brekken/Thorpe/etal article: Fhu/Bavi vs. APS-related Pregnancy Complications & Thrombosis (PLOS ONE multidisciplinary Open Access journal)...
7-27-16/PLoS One: “Identification of a Monoclonal Antibody That Attenuates Antiphospholipid Syndrome-Related Pregnancy Complications & Thrombosis”
http://www.ncbi.nlm.nih.gov/pubmed/27463336 Rec.1-7-16, Acc.6-21-16, Pub.7-27-16
Mineo C1, Lanier L1, Jung E1, Sengupta S1, Ulrich V1, Sacharidou A1, Tarango C1, Osunbunmi O1, Shen YM2, Salmon JE3, Rolf Brekken 4,5, Xianming Huang 4, Philip Thorpe 4, Philip W Shaul 1
1 Ctr. for Pulmonary & Vascular Biology, Dept of Pediatrics, UTSW-MC/Dallas
2 Dept of Internal Medicine, UTSW-MC/Dallas
3 Dept of Medicine, Hosp. for Special Surgery, Weill Cornell Medical College, NYC
4 Dept of Pharmacology & the Hamon Ctr forTherapeutic Oncology Res., UTSW-MC/Dallas
5 Dept of Surgery, UTSW-MC/Dallas
**Dr. Philip Shaul: https://profiles.utsouthwestern.edu/profile/16558/philip-shaul.html
**PLOS ONE Journal: a multidisciplinary Open Access journal http://journals.plos.org/plosone
ABSTRACT
In the antiphospholipid syndrome (APS), patients produce antiphospholipid antibodies (aPL) that promote thrombosis and adverse pregnancy outcomes. Current therapy with anticoagulation is only partially effective and associated with multiple complications. We previously discovered that aPL recognition of cell surface B2-glycoprotein I (B2-GPI) initiates apolipoprotein E receptor 2 (apoER2)-dependent signaling in endothelial cells and in placental trophoblasts that ultimately promotes thrombosis and fetal loss, respectively. Here we sought to identify a monoclonal antibody (mAb) to B2-GPI that negates aPL-induced processes in cell culture and APS disease endpoints in mice. In a screen measuring endothelial NO synthase (eNOS) activity in cultured endothelial cells, we found that whereas aPL inhibit eNOS, the mAb 1N11 [1N11 is Fully-Human Bavituximab, aka PGN635/AT004] does not, and instead 1N11 prevents aPL action. Coimmunoprecipitation studies revealed that 1N11 decreases pathogenic antibody binding to B2-GPI, and it blocks aPL-induced complex formation between B2-GPI and apoER2. 1N11 also prevents aPL antagonism of endothelial cell migration, and in mice it reverses the impairment in reendothelialization caused by aPL, which underlies the non-thrombotic vascular occlusion provoked by disease-causing antibodies. In addition, aPL inhibition of trophoblast proliferation and migration is negated by 1N11, and the more than 6-fold increase in fetal resorption caused by aPL in pregnant mice is prevented by 1N11. Furthermore, the promotion of thrombosis by aPL is negated by 1N11. Thus, 1N11 has been identified as an mAb that attenuates APS-related pregnancy complications and thrombosis in mice. 1N11 may provide an efficacious, mechanism-based therapy to combat the often devastating conditions suffered by APS patients.
DISCUSSION:
...The potential clinical impact of 1N11 in patients with APS is substantial. aPL are positive in 10% of all patients with deep vein thrombosis, in 11% of all patients with myocardial infarction, and in 13% of all patients with stroke [62]. In addition, despite oral anticoagulation therapy, individuals with a laboratory diagnosis of APS have a 44% likelihood of suffering a thrombotic event within 10 years [63]. As importantly, although the reported rates of bleeding complications vary widely for APS patients receiving anticoagulation, the incidence can be as high as 10% [64]. The impact of APS on pregnancy is also considerable. It has been estimated to complicate 5–7% of all pregnancies, and despite current anticoagulation therapy, the rate of fetal loss in APS is 18%, IUGR occurs in 13–33% of APS pregnancies, and the rate of prematurity is 16–50%, with an average gestational age of 31 weeks [65–70]. Moreover, when anticoagulation is chosen as a means to combat any of the numerous complications of APS, major dilemmas remain regarding the level of anticoagulation to target and the duration of therapy [71]. Spring-boarding from the present discovery of 1N11 as a highly-effective, mechanism-based treatment for APS in a comprehensive series of mouse models of APS-related disorders, clinical studies of 1N11 now warrant consideration.
FULL ARTICLE: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0158757
Exosome-RNA.com – everything you want to know about Exosomes
= = = = = = http://www.exosome-rna.com
“Exosome-RNA.com is a place to find the latest research and industry news and information about exosome RNA. Exosomes are cell-derived vesicles that are present in many and perhaps all biological fluids, including blood, urine, and cultured medium of cell cultures. Exosomes contain various molecular constituents of their cell of origin, including proteins and RNA. It is becoming increasingly clear that exosomes have specialized functions and play a key role in, for example, coagulation, intercellular signaling, and waste management.”
= = = = = = = = = = = = = = = = =
7-14-16/PR: Peregrine Licenses Novel Exosome-Based Cancer Detection and Monitoring Technology from UT Southwestern Medical Center
--New Technology Efficiently Builds on the Company's Existing Phosphatidylserine (PS) Targeting Platform and Assay Development Capabilities
--Stand Alone Program That Offers Significant Value Creation Potential and Early Partnering Opportunities
--New Technology to Also be Evaluated in Conjunction with Ongoing Bavituximab Clinical Development Program
...SEE (incl. A.Schroit/P.Thorpe article & UTSW/Peregrine U.S. & Intl. Patents) http://tinyurl.com/zszd4fj
May God Bless Your Father, You, and Your Family. eom
ATM Sales Summary (3/2009–7/14/2016). Also, PPHM O/S Shares History Table (’06–curr.) at the bottom of this post…
At 7-11-16, shares O/S = 241,456,721sh.
ATM = “At-The-Market Sales Issuance”
I. WM-SMITH 3-2009:
• $7.5mm ATM/Wm.SMITH 3-26-09: $7,500,000gr. / 2,150,759sh. = $3.49/sh. (commiss: 3%)
• $25mm ATM/Wm.SMITH 7-14-09: $25,000,000gr. / 7,569,314sh. = $3.30/sh. (commiss: 3%/1st$15mm, then 2%)
*Total Raised via WmSmith ATM Sales thru 7-31-10:
. . . . $32,500,000gr. / 9,720,073sh. = $3.34/sh.
II. MLV 6-2010: http://www.mlvco.com
$15mm ATM/MLV 6-22-10 (commiss: 2%) Form424: http://tinyurl.com/24txkxb
• Sold 6/22/10–10/31/10: $6,840,000gr. / 4,031,018sh. = $1.70/sh.
• Sold 11/1/10–11/30/10: $7,407,000gr. / 4,711,611sh. = $1.57/sh.
• Sold 12/1/10–1/31/11: $753,000gr. / 471,744sh. = $1.60/sh.
*Total Raised via MLV June’10 ATM Sales thru 1-31-11:
. . . . $15,000,000gr. / 9,214,373 = $1.63/sh.
III. MLV 12-2010: “Dec’10 AMI Agreement” http://www.mlvco.com
$75mm ATM/MLV 12-29-10 (commiss: max=5%) Form8K: http://tinyurl.com/2a6w76g
(pursuant to $75mm S-3 Shelf Reg. filed 12-17-10: http://tinyurl.com/2469b2d )
• Sold 12/29/10-1/31/11: $6,460,000gr. / 2,385,862sh. = $2.71/sh.
• Sold 2/1/11-2/28/11: $2,358,000gr. / 998,142sh. = $2.36/sh.
• Sold 3/1/11-4/30/11: $4,470,000gr. / 1,840,487sh. = $2.43/sh.
• Sold 5/1/11-7/31/11: $3,713,000gr. / 1,912,576sh. = $1.94/sh.
• Sold 8/1/11-10/31/11: $5,582,000gr. / 4,727,840sh. = $1.18/sh.
• Sold 9-2-12 Roth Direct: $6,940,000gr./ 6,252,252sh. = $1.11/sh.
• Sold 11/1/11-1/31/12: $10,961,000gr. / 10,308,025sh. = $1.06/sh.
• Sold 2/1/12-2/29/12: $5,871,000gr. / 5,726,946sh. = $1.03/sh.
• Sold 3/1/12-4/30/12: $1,263,000gr. / 2,198,543sh. = $.57/sh.
• Sold 5/1/12-6/30/12: $1,496,000gr. / 2,752,691sh. = $.54/sh.
• Sold 7/1/12-9/26/12: none**
• Sold 9/27/12-10/31/12: $16,719,000gr./ 18,557,928 = $.90/sh.
• Sold 11/1/12-11/30/12: $7,296,000gr./ 9,220,313 = $.79
• Sold 12/1/12-1/31/13: $1,540,000gr./ 1,131,282 = $1.36
• Sold 2/1/13-3/12/13: $330,000gr./ 201,154 = $1.64
*Total Raised via MLV Dec’10 ATM Sales thru 3-12-2013:
. . . . $75,000,000gr. / 68,214,041 = $1.10sh.
IV. MLV 12-2012: “Dec’12 AMI Agreement” http://www.mlvco.com
$75mm ATM/MLV 12-29-12 (commiss: max=5%) Form8K: http://tinyurl.com/2a6w76g
(pursuant to $75mm S-3 Shelf Reg. filed 3-9-12: http://tinyurl.com/7dl7pjm )
• Sold 2/1/13-3/12/13: $4,475,000gr. / 3,132,402sh. = $1.43/sh.
• Sold 3/13/13-4/30/13: $8,897,000gr. / 6,188,273sh. = $1.44/sh.
• Sold 5/1/13-7/11/13: $12,729,000gr. / 7,927,016sh. = $1.61/sh.
• Sold 7/12/13-7/31/13: $2,468,000gr. / 1,690,864sh. = $1.46/sh.
• Sold 8/1/13-9/9/13: $4,372,000gr. / 3,057,431sh. = $1.43/sh.
• Sold 9/10/13-10/31/13: $4,708,000gr. / 3,262,958sh. = $1.44/sh.
• Sold 11/1/13-12/6/13: NONE – see 10Q note below.
• Sold 12/7/13-1/31/14: $28,130,000gr. / 16,045,717sh. = $1.75/sh.
• Sold 2/1/14-4/30/14: $3,017,000gr. / 1,543,383sh. = $1.95/sh.
• Sold 5/1/14-7/31/14: $425,000gr. / 226,700sh. = $1.92/sh.
• Sold 8/1/14-10/31/14: $3,891,000gr. / 2,494,835sh. = $1.56/sh.
• Sold 11/1/14-1/31/15: $1,878,000gr. / 1,261,825sh. = $1.49/sh.
*Total Raised via MLV Dec’12 ATM Sales thru 10-31-2014:
. . . . $75,000,000gr. / 46,831,404 = $1.60sh.
V. MLV 6-2014: “Jun’14 AMI Agreement – up to $25mm” http://www.mlvco.com
• Sold 11/1/14-1/31/15: $1,193,000gr. / 869,504sh. = $1.43/sh.
• Sold 2/1/15-3/12/15: $6,204,000gr. / 4,354,954sh. = $1.44/sh.
• Sold 3/13/15-4/30/15: $6,147,000gr. / 4,457,299sh. = $1.38/sh.
• Sold 5/1/15-7/14/15: $8,896,000gr. / 6,534,400sh. = $1.36/sh.
• Sold 7/15/15-7/31/15: $1,270,000gr. / 1,003,830sh. = $1.27/sh.
• Sold 8/1/15-9/9/15: $1,290,000gr. / 1,091,508sh. = $1.18/sh.
*Total Raised via MLV Jun’14 ATM Sales thru 9-9-2015:
. . . . $25,000,000gr. / 18,311,495 = $1.37/sh.
VI. MLV 8-2015: “Aug’15 AMI Agreement – up to $30mm” http://www.mlvco.com
• Sold 8/7/15-9/9/15: $892,000gr. / 1,091,000sh. = $1.18/sh.
• Sold 9/10/15-10/31/15: $4,294,000gr. / 4,059,478sh. = $1.06/sh.
• Sold 11/1/15-12/10/15: $2,261,000gr. / 1,939,413sh. = $1.17/sh.
• Sold 12/11/15-1/31/16: *NO ATM SALES*, per 1-31-16 10Q iss. 3-9-16
• Sold 2/2/16-4/30/16: *NO ATM SALES*, per 4-30-16 10Q iss. 7-14-16
• Sold 5/1/16-7/14/16: $937,000gr. / 1,876,918sh. = $.50/sh.
. . . . $8,384,000gr. / 8,628,569 = $.97/sh.
VII. NOBLE 8-2015: “Aug’15 Eq.Dist. Agreement – up to $20mm” http://www.noblelsp.com
• Sold 11/1/15-12/10/16: $2,371,000gr. / 1,925,844sh. = $1.23/sh.
• Sold 12/11/15-1/31/16: $2,857,000gr. / 2,529,434sh. = $1.13/sh.
• Sold 2/1/16-4/30/16: $1,741,000gr. / 4,017,010sh. = $.43/sh.
• Sold 5/1/16-7/14/16: $1,232,000gr. / 2,649,318sh. = $.47/sh.
. . . . $8,201,000gr. / 11,121,606 = $.74/sh. '
TOTAL ALL A-T-M SALES – INCEPTION (3-2009) THRU 9-9-2015:
==> $239,085,000gr. / 172,041,561sh. = $1.39/sh.
- - - - - - - - - -
10-31-11 10Q: “During the 6mos. 10-31-11, we sold 6,440,416 shares of our common stock at mkt-prices for gross proceeds of $9,295,000 under the Dec’10 AMI Agreement before deducting commissions and other issuance costs of $260,000”
1-31-12 10Q: “During the 9mos. ended 1-31-12, we sold 16,948,441 shares of our common stock at mkt-prices for gross proceeds of $20,256,000 under the Dec’10 AMI Agreement before deducting commissions and other issuance costs of $482,000. …During Feb.2012, we sold an addl. 5,726,946 shares of common stock at market prices under the Dec’10 AMI Agreement in exchange for aggregate gross proceeds of $5,871,000. As of 2-29-12, gross proceeds of $38,644,000 remained available under our 2 effective shelf registration statements.”
4-30-12 10K: “Under the Dec. 2010 AMI Agreement with MLV …for aggregate gross proceeds of up to $75,000,000… During FY’s 2011 (5’10-4’11) and 2012 (5’11-4’12), we sold 30,098,421 shares of common stock at market prices under the Dec.2010 AMI for aggregate gross proceeds of $40,678,000 before deducting commissions & other issuance costs of $917,000. As of April 30, 2012, aggregate gross proceeds of up to $27,382,000 remained available under the Dec.2010 AMI… Subsequent to April 30, 2012 and through June 30, 2012, we sold 2,752,691 shares of common stock at mkt prices under the Dec.2010 AMI for aggregate gross proceeds of $1,496,000… Under the registered direct public offering dated Sept. 2, 2011, we entered into separate subscription agreements with 3 institutional investors, pursuant to which we sold an aggregate of 6,252,252 shares of our common stock at a purchase price of $1.11/sh. for gross proceeds of $6,940,000 before deducting placement agent fees and other offering expenses of $525,000.”
10-31-12 10Q: “During the 6mos. 10-31-12, we sold 21,310,619 shares… at varying mkt-prices under the Dec’10 AMI Agreement for gross proceeds of $18,215,000 before deducting commissions and other issuance costs of $620,000. From 11-1-12 thru 11-30-12, we sold 9,220,313 shares gross of $7,296,000. As of 11-30-12, aggregate gross proceeds of up to $1,871,000 remained available under the Dec’10 AMI Agreement. As of 11-30-12, gross proceeds of $151,871,000 remained available under 2 effective shelf registration statements.”
1-31-13 10Q/pg.11: “DEC’10-AMI(max=$75mm): During the 9 mos. ended 1-31-13, we sold 31,662,214 shares at varying mkt-prices for gross proceeds of $27,051,000 before deducting commissions/other-costs of $885,000. As of 1-31-13, gross proceeds of up to $330,000 remained available. From 2-1-13 – 3-12-13, we sold 201,154 shares at mkt prices for gross $330,000. As of 3-12-13, we had raised the full amt of gross proceeds available… DEC’12-AMI(max=$75mm): As of 1-31-13, we had not sold any shares. From 2-1-13 - 3-12-13, we sold 3,132,402 shares at mkt prices for gross proceeds of $4,475,000. As of 3-12-13, gross proceeds of up to $70,525,000 remained available.”
4-30-13 10K/pg.F26: Dec’12-AMI(max=$75mm)Agreement – During FY’13, we sold 9,320,675 shares gross proceeds of $13,372,000 before deducting commissions and other issuance costs of $337,000. As of April 30, 2013, gross proceeds of up to $61,628,000 remained available under the Dec’12-AMI. From 5/1/13 – 7/11/13, we sold 7,927,016 shares for gross proceeds of $12,729,000. As of 7-11-13, gross proceeds of $48,899,000 remained available under the Dec’12-AMI. http://tinyurl.com/p58jcbw
7-31-13 10Q/pg.10: During the 3mos ended 7-31-13, we sold 9,617,880 shares at mkt prices under the Dec’12 AMI Agreement for gross proceeds of $15,197,000 before deducting commissions and other issuance costs of $491,000. As of July 31, 2013, gross proceeds of up to $46,431,000 remained available under the Dec’12-AMI. From 8-1-13 – 9-9-13, we sold 3,057,431 shares for gross proceeds of $4,372,000. As of 9-9-13, gross proceeds of $42,059,000 remained available under the Dec’12-AMI.
10-31-13 10Q/pg.10: During the 6mos ended 10-31-13, we sold 15,938,269 at mkt prices under the Dec’12 AMI for gross proceeds of $24,277,000 before deducting costs of $722,000. As of 10-31-13, aggregate gross proceeds of up to $37,351,000 remained available under the Dec’12 AMI.
***NOTE: There is no stmt in the 10-Q regarding AMI Sales subsequent to 10-31-13 (thru 12-6-13) as has been the case in the 10Q’s for years – the assumption being: NO AMI Sales made 11/1/13-12/6/13, a period where O/S shares only went up by 77,149.
1-31-14 10Q/pg.11: During the 9 mos. ended 1-31-14, we sold 31,983,986 shares under the Dec’12/AMI for gross $52,407,000 before deducting commissions & other iss. costs of $1,427,000. As of 1-31-14, gross proceeds of up to $9,221,000 remained available under the Dec’12/AMI. http://tinyurl.com/pxcjocw
4-30-14 10K pg.F25: “During FY14, we sold 33,527,369 shares under the Dec’12/AMI for gross proceeds of $55,424,000 before deducting commissions & other iss. costs of $1,504,000. As of April 30, 2014, aggregate gross proceeds of up to $6,204,000 remained available under the December 2012 AMI Agreement.” http://tinyurl.com/mhva3k3
7-31-14 10Q/Pg5: During the 3mos. ended 7-31-14, we raised $10,000,000 in aggregate gross proceeds from the sale of our 10.50% SeriesE Convertible Preferred Stock under an At Market Issuance Sales Agreement. Pg.11: During the 3mos. ended 7-31-14, we sold 226,700sh. under the Dec’12-2012 AMI Agreement for gross of $435,000 before deducting commissions & other costs of $14,000. As of 7-31-14, gross of up to $5,769,000 remained available under the Dec’12-2012/AMI. On 6-13-14, we entered into an At Market Issuance Sales Agreement (“June2014/AMI”), with MLV, pursuant to which we may sell shares of our common stock through MLV, for aggregate gross proceeds of up to $25,000,000, in registered transactions from our shelf registration statement on Form S-3. As of 7-31-14, we had not sold any shares of common stock under the June 2014 AMI Agreement. http://tinyurl.com/phw6dkp
10-31-14 10Q/Pg12: COMMON: During 6mos. ended 10-31-14, we sold 2,721,535 sh. at mkt prices under the Dec’12-AMI for gross proceeds of $4,326,000 before deducting commissions and other issuance costs of $113,000. As of 12-31-14, gross proceeds of up to $1,878,000 remained available under the Dec’12-AMI. PREFERRED: During 6mos. ended 10-31-14, we sold 402,858 sh. at mkt prices gross proceeds of $10,070,000 before deducting commission and other issuance costs of $552,000. As of 10-31-14, gross proceeds of up to $19,930,000 remained available under the Series E AMI Agreement. http://tinyurl.com/m6ldhg7
1-31-15 10Q/Pg12: COMMON: During the 9mos. ended 1-31-15, we sold 3,983,360 sh. at mkt prices under the Dec’12-AMI for gross proceeds of $6,204,000 before deducting commissions and other issuance costs of $162,000. As of 1-31-15, we had raised the full-amt of gross proceeds available to us under the Dec’12-AMI. PREFERRED:
Jun’14-AMI: On 6-13-14, we entered into an AMI with MLV…up to $25mm… ,000,000, in registered transactions from our shelf registration statement on Form S-3 (File No. 333-180028). During the 9mos. ended 1-31-15, we sold 869,504 sh. at mkt prices under the Jun’14-AMI for gross of $1,193,000 before deducting commissions and other issuance costs of $31,000. As of 1-31-15, gross proceeds of up to $23,807,000 remained available. Subsequent to 1-15-15 and thru 3-12-15, we sold 4,354,954 sh. of common at mkt prices under the Jun’14-AMI for gross of $6,204,000. As of 3-12-15, 2015, gross proceeds of $17,603,000 remained available under the Jun’14-AMI.
PREFERRED: During the 9mos. ended 1-31-15, we sold 405,004 sh. of our Series E Preferred Stock at mkt prices under the Series E AMI Agreement for gross proceeds of $10,121,000 before deducting commission and other issuance costs of $553,000. As of 1-31-15, 2015, gross proceeds of up to $19,879,000 remained available under the Series E AMI. http://tinyurl.com/mwedt8w
4-30-15 10K pg.F25: During FY’15 we sold 9,681,757sh. under the June’14/AMI for $13,544,000, before deducting costs of $352,000. As of 4-30-15, $11,456,000 remained available. Pg.F35: Subsequent to 4-30-15 & thru 7-14-15, we sold 6,534,400sh. for $8,896,000. A/o 7-14-15, $2,560,000 remain. http://tinyurl.com/ocrtkuj
7-31-15 10Q/Pg12+18: During the 3mos ended 7-31-15, we sold 7,538,230sh. Under the JUNE2014 AMI for gross of $10,166,000 before deducting commiss/iss-costs of $275,000. As of 7-31-15, gross of $1,290,000 remained available under the JUNE2014 AMI, as amended. JUNE2014 AMI: subsequent to 7-31-15 and thru 9-9-15, we sold 1,091,508sh. gross of $1,290,000. As of 9-9-15, 2015, we had raised the full amount available under the June2014 AMI. AUG2015 AMI: on 8-7-15, we entered into an At Market Issuance Sales Agreement with MLV, for gross proceeds of up to $30,000,000, 2.5% commission; as of 9-9-15, we sold 752,760sh. under the AUG2015 AMI for gross of $892,000. http://tinyurl.com/pemub47
10-31-15 10Q/Pg13+19: During 6mos ended 10-31-15, we sold 4,812,238sh at mkt prices under MLV AUG2015 AMI for gross=$5,186,000 before deducting commiss/costs of $132,000. As of 10-31-15, gross proceeds of up to $24,814,000 remained available. Subsequent to 10-31-15, thru 12-10-15, we sold 1,939,413sh for gross=$2,261,000. As of 12-10-15, $22,553,000 remained.
On 8-7-15, we entered into an “Equity Distribution Agreement” with Noble Life Science Partners, pursuant to which we may sell shares for gross proceeds of up to $20,000,000 (commission=2.5% of gross). As of 10-31-15, we had not sold any shares… Subsequent to 10-31-15 & thru 12-10-15, we sold 1,925,844 shs. at mkt prices for gross=$2,371,000. As of 12-10-15, gross of up to $17,629,000 remained available.
On 10-30-15, we entered into a Common Stock Pur. Agreement with EASTERN CAPITAL Ltd: sold 18,518,518shs @1.08/sh for gross=$20,000,000 before deducting issuance costs of $1,000.
10Q: http://tinyurl.com/zdbo9rv [10-30-15: Kenneth Dart (Eastern Capital) acquires 13.1% stake (30,106,945sh.) in PPHM http://tinyurl.com/24qctos ]
1-31-16 10Q/Pg13: During 9mos ended 1-31-16, we sold 6,751,651sh at mkt prices under MLV AUG2015 AMI for gross=$7,447,000 before commiss/costs =$190,000. As of 1-31-16, gross of $22,553,000 remained available. Subsequent to 10-31-15 thru 12-10-15, we sold 1,939,413sh for gross=$2,261,000. As of 12-10-15, $22,553,000 remained.
NOBLE Eq-Dist-AMI: during 9mos. ended 1-31-16, we sold 4,455,278shs. for gross of $5,228,000, commissions=$131,000. As of 1-31-16, $14,772,000 remained… http://tinyurl.com/hdgto9y
4-30-16 10K pg.F24+25: NOBLE Eq-Dist-AMI - FY’16 sales: 8,472,288sh. For gross=$6,969,000. As of 4-30-16, gross remaining=$13,031,000. Pg.F35/SUBSEQUENT EVENTS: NOBLE/EQ 5/1/16-7/14/16, sold 2,649,318sh. for gross=$1,232,000, a/o 7-14-16, $11,799,000 remain available. MLV AUG2015 AMI: 5/1/16-7/14/16, sold 1,876,918sh. for gross=$937,000, a/o 7-14-16, $21,616,000 remain available. 10K: http://tinyurl.com/zgognwz
PREFERRED SHARES:
4-30-15 10K/p.F26: On 6-13-14, we entered into an At Market Issuance Sales Agreement with MLV, pursuant to which we may issue & sell shares of our Series E Preferred Stock through MLV, as agent, for gross proceeds of up to $30,000,000, in registered transactions from our Jan2014 Shelf. During FY’2015, we sold 799,764 shares of our Series E Preferred Stock at mkt prices for gross $19,205,000 before deducting commissions/costs of $1,002,000. As of 4-30-15, gross proceeds of up to $10,795,000 remained available under the Series E AMI Agreement.
NOTE: One of the holders of Preferred is KENNETH DART (EASTERN CAPITAL), who in a 2-13-15 SG14G ( http://tinyurl.com/k4nsfuu ) reported their 240,000sh. Preferred holdings as 2,000,000 common shares (SHARED VOTING POWER: 9,921,760,% OF CLASS REPRESENTED: 5.4%).
“which has a liquidation preference of $25.00/sh. and a conversion price of $3.00/sh.” 2,000,000 / 240,000 = 8.333
- - - - - - - - - - - - - - - - -
Latest 10K 4-30-16 iss. 7-14-16 http://tinyurl.com/zgognwz PR: http://tinyurl.com/h8eqtg5 (Cash 4-30-16=$61.4mm)
Latest 10Q 1-31-16 iss. 3-9-16 http://tinyurl.com/hdgto9y PR: http://tinyurl.com/gom7md5 (Cash 1-31-16=$67.5mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
- - - - - - - - - - - - - - - - - -
PPHM’S ATM PHILOSOPHY, CFO PAUL LYTLE, 12-9-10 CC:
“Beyond these 2 sources of capital ([Avid & Gov’t], we have raised addl. capital through the equity markets and it’s important to note that over the past 3 years we have sold every share at market prices [“ATM”], without warrants, without discounts. We continue to be active in the investment community and we have had strong interest from institutional investors intrigued by our clinical data, by our multiple trials to evaluate Bavituximab’s broad therapeutic potential, and by the interim survival data we have seen from our novel brain cancer therapy Cotara. Our goal is to maintain a balanced financial approach with multiple sources of capital and to carefully manage our cash burn as we continue to advance these programs.” http://tinyurl.com/24xmcsn
= = = = = = = = = = = = = = = = = =
PPHM - O/S Shares History (’06–curr.)
4-30-06 35,876,438
1-31-07 39,222,440
4-30-07 39,222,440
7-6-07 45,233,123
7-31-07 45,242,123
10-31-07 45,242,123
1-31-08 45,242,123
4-30-08 45,242,123
7-31-08 45,242,123
10-31-08 45,242,123
1-31-09 45,242,123
4-30-09 45,537,711
7-10-09 47,392,883
7-31-09 47,393,783
10-31-09 48,869,563 +1,475,780
1-31-10 50,903,404 +2,033,841
4-30-10 53,094,894 +2,191,490
6-21-10 54,388,917 +1,294,023 (6-22-10 ATM/mlv Form424)
7-9-10 55,069,449 +475,987 (4-30-10 10K iss. 7-14-10)
7-31-10 55,784,955 +715,506
10-31-10 59,220,742 +3,435,787
11-30-10 63,932,353 +4,711,611 (10-31-10 10Q iss. 12-9-10)
12-15-10 64,404,097 +471,744 (12-17-10 S-3: $75M Shelf Reg.)
1-31-11 66,813,419 +2,409,322
2-28-11 67,885,811 +1,072,392 (1-31-11 10Q iss. 3-11-11)
4-30-11 69,837,142 +1,951,331
7-8-11 71,069,858 +1,232,716 (4-30-11 10K iss. 7-14-11)
8-22-11 72,704,647 +1,634,789 (Proxy iss. 8-26-11)
8-31-11 73,284,016 +579,369 (424B5 iss. 9-2-11)
9-8-11 79,536,268 +6,252,252 (Roth Sale to 3 Inst’s @ $1.11/sh.)
10-31-11 82,638,201 +3,101,933
12-9-11 86,788,817 +4,150,616 (10-31-11 10Q iss. 12-12-11)
1-31-12 93,146,226 +6,357,409
2-29-12 98,873,172 +5,726,946 (1-31-12 10Q iss. 3-9-12)
4-30-12 101,421,365 +2,548,193
7-13-12 104,174,056 +2,752,691 (4-30-12 10K iss. 7-16-12)
7-31-12 104,178,431 +4,375 (7-31-12 10Q iss. 9-10-12)
8-16-12 104,191,176 +12,745 (prelim. proxy 14A http://tinyurl.com/c48bvof )
9-7-12 104,191,176 nochg (7-31-12 10Q iss. 9-10-12)
10-31-12 123,310,188 +19,119,012
12-7-12 132,539,783 +9,229,595 (10-31-12 10Q iss. 12-10-12)
1-31-13 133,770,614 +1,230,831
3-12-13 137,110,758 +3,340,144 (1-31-13 10Q iss. 3-12-13)
4-30-13 143,768,946 +6,658,188 (4-30-13 10K iss. 7-11-13)
7-5-13 151,602,765 +7,833,819 (4-30-13 10K iss. 7-11-13)
7-31-13 153,506,811 +1,904,046
9-5-13 156,461,114 +2,954,303 (7-31-13 10K iss. 9-9-13)
10-31-13 160,248,742 +3,781,628
12-6-13 160,325,891 +77,149 (10-31-13 10K iss. 12-10-13)
1-31-14 176,453,261 +16,127,370
3-3-14 176,481,054 +27,793 (1-31-14 10Q iss. 3-7-14)
4-30-14: 178,871,164 +2,390,110
7-7-14: 179,209,458 +338,294 (4-30-14 10-K cover page, iss. 7-14-14)
7-31-14: 179,216,032 +6,574 (7-31-14 10Q iss. 9-9-14)
8-22-14: 179,226,424 +10,392 (8-28-14 Proxy/Def14A)
9-5-14: 179,505,424 +279,000 (7-31-14 10Q iss. 9-9-14)
10-31-14: 182,000,583 +2,495,159 (10-31-14 10Q iss. 12-10-14)
12-5-14: 182,081,234 +80,651 (10-31-14 10Q cover pg., iss. 12-10-14)
12-19-14: 182,081,234 -0- (12-23-14 S-3)
1-31-15: 184,244,698 +2,163,464 (1-31-15 10Q iss. 3-12-15)
3-12-15: 188,332,872 +4,088,174 (“ “ “)
4-30-15: 193,346,627 +5,013,755 (4-30-15 10-K iss. 7-14-15)
7-10-15: 199,934,918 +6,588,291 (4-30-15 10-K/cover-pg, iss. 7-14-15)
7-31-15: 200,983,948 +1,049,030 (7-31-15 10Q iss. 9-9-15)
9-4-15: 202,124,031 +1,140,083 (“ “ “)
10-31-15: 225,824,551 +23,700,520 (10-31-15 10Q iss. 12-10-15)<=Incl. 18.5mm sh. Dart/EastCAP @1.08
12-9-15: 229,701,808 +3,877,257 (10-31-15 10Q iss. 12-10-15)
1-31-16: 232,231,242 +2,529,434 (1-31-16 10Q iss. 3-9-16)
3-8-16: 233,738,426 +1,507,184 (“ “ “)
4-30-16: 236,930,485 +3,192,059 (4-30-16 10K iss. 7-14-16)
7-11-16: 241,456,721 +4,526,236 (“ “ “)
O/S WARRANTS & STOCK-OPTIONS A/O 4-30-2016 (10K pg.F29/31):
• WARRANTS: As of 4-30-2016, warrants to purchase 273,280 shares at an exercise price of $2.47 were outstanding and are exercisable through Aug30 2018. These warrants were issued in FY’13 in connection with the Aug.2012 [Oxford] loan agreement, which was paid in full Sept.2012.
• STOCK OPTIONS OUTSTANDING A/O 4-30-2016: 23,751,261 shares at a wgt.avg. exercise price of $1.48. (during 12mos. ended 4-30-16, 1,034,397sh. exercised at avg=.52)
= = = = = = = = = = =PREFERRED STOCK:
...2-5-14: PPHM Announces Public Offering of 10.5% Series E Convertible Preferred Stock http://tinyurl.com/lkxsna6
...2-11-14: PPHM Raises net $16.2mm selling 700k Preferred Shares with 10.5% div. at $25/sh, convertible to common at $3/sh http://tinyurl.com/jwmsnsk (8-K)
...6/14/14-7/14/13: PPHM Raises net $9.5mm selling 400k Preferred Shares with 10.5% div. at $25/sh, convertible to common at $3/sh http://tinyurl.com/mhva3k3 (4-30-14 10-K pg. F-34; $20mm gross remaining)
7-14-16 Qtly CC-Transcript, PR(Fins/Devs Q4FY16/fye4-30-16), updated Avid Revenues History Table By Quarter…
=> Total Revs May06-Apr16: $173.6mm/Avid + $24.1mm/Govt + $2.4mm/Lic. = $200.2mm. Cash at 4-30-16: $61.4mm
As of July 11 2016, there were 241,456,721 shares outstanding.
This large post has 3 sections:
I. 7-14-16 Q4/FY16 Qtly. Earnings Conf. Call TRANSCRIPT (fy/e 4-30-16)
II. 7-14-16 PPHM Press Release: Q4/FY16 Earnings & Developments
III. Updated Table of Avid Revenues By Quarter (May’06-Current)
…Recall: Peregrine’s FY runs May-Apr, so FY’16 = May’15-Apr’16.
((( Orig. transcript from SeekingAlpha.com [ http://tinyurl.com/zeqcxyc ], with numerous corrections made. )))
Link to webcast replay: http://ir.peregrineinc.com/events.cfm => http://edge.media-server.com/m/p/i72j93vc
FULL TRANSCRIPT…
7-14-2016 FY’16/Q4 Earnings Conf. Call (fy/e 4-30-16)
WELCOME & FWD-LOOKING STATEMENTS: Tim Brons, Vida Strategic Partners (IR) http://www.peregrineinc.com
Speakers: Steve King, Rob Garnick, Joe Shan, Jeff Hutchins, Paul Lytle; Q&A session.
CEO STEVE KING – OPENING COMMENTS:
Today, with the filing of the 10-K, it's a good opportunity to take a look back over the past year, a year at Peregrine that was marked by surprising highs and unfortunate lows. Leading the highs was the continued remarkable growth for our biomanufacturing business, Avid Bioservices, which is truly growing at a faster rate than even we expected. And of course, the low coming with the early discontinuation of our Phase III SUNRISE study based on passing the futility threshold at its first interim data analysis. That development was a particularly bitter pill to swallow for everyone that had put in such a phenomenal effort to advance the program up to that point. Following the setback, we took the opportunity to take full stock of the company, including evaluating our key assets, identifying opportunities for development, and strategic approaches for financing the company going forward, with the same ultimate goal of helping patients with devastating diseases while growing shareholder value. Out of this careful analysis, we have settled on a strategy to focus the company's resources primarily on continuing to grow our biomanufacturing business, Avid Bioservices, while continuing to advance R&D efforts through smaller clinical trials and the development of new technologies that can be partnered in an early stage. With the goal of becoming cash flow positive over the next couple of years, this strategy will allow us to increase shareholder value in several ways.
First, grow the value of our base, namely our manufacturing business. Manufacturing companies are currently in high demand, with values ranging from 2 to 5 times sales, depending on the revenue growth potential. We believe Avid should be highly valued from a shareholder perspective, based on the current consistent year-over-year growth, almost a 40% compounded annual growth rate over the past 5 years, with the remarkable 66% growth this past year, all coming from one facility. With the 2nd facility [“Myford”] now in full operation, already booked into next year, adding to the revenue growth potential for FY17 [May16-Apr17], with planning already underway for a 3rd facility that will be commissioned and ready for production in 1H/2017, setting the stage for nice potential growth going into the following FY. Taken together, these 3 facilities have the potential to generate in access of $110mm in revenues, with even more potential upside coming from the possibility of expanding our service offerings and, of course, the success of our commercial clients. So, by focusing our resources on growing Avid's revenues, we simultaneously add shareholder value in 2 ways. We increase the value of the base business, and increasing revenues decreases our need to raise funds through the equity markets, with the goal being to become cash flow positive, potentially eliminating the need for future dilution. We are in a unique position as a contract development and mfg. organization, or CDMO, because we have both drug development & mfg. expertise. We already work with clients ranging from small startups to some of the biggest pharma companies, and we look forward to helping more clients to bring their important products to the patients that need them.
Concurrent with growing our mfg. business, we will also continue to leverage our PS Targeting platform in 2 ways. First, the company will continue to extract clinical data from the SUNRISE Phase III trial. While trial enrollment was discontinued, the trial is still ongoing, with some patients still receiving bavituximab maintenance therapy. In addition, we have collected thousands of samples that are, or will be, analyzed in order to identify those patients that received benefit from including bavituximab into their treatment regimen. We expect this data will be instrumental in guiding the advancement of bavituximab in combination with immune-stimulating therapies. In fact it is very prudent to understand as much as we can from the SUNRISE trial before pushing into future company-sponsored studies, whether alone or with our collaborators. Joe will discuss these efforts during his prepared remarks.
In addition to bavituximab program which continues to have tremendous potential value, the company announced earlier today that it has licensed-in a Novel PS Exosome Technology, with the potential to detect and monitor cancer at an early stage through a simple blood test [ 7-14-16: http://tinyurl.com/zszd4fj ]. I recognize that some of you might think this theme is contrary to controlling spending as we move toward profitability, but in fact we believe that given our already existing knowledge base in Targeting PS and our already available infrastructure for developing & validating tests, that so a very modest capital investment we can quickly reach proof-of-concept with a goal of partnering this technology, which could then bring in additional revenue, with another potential upside of the technology being that it can possibly be useful in the continued development of bavituximab. Jeff will talk more about this during his prepared remarks. Given the strategy of R&D targeted toward early partnering, will allow the company to continue its research and development activities with significant upside coming from partnering as we move to our profitability. With that I will turn the call over to Rob, our Head of Quality and Regulatory for a few thoughts on his perspective of the potential for growing our base CDMO business.
ROBERT GARNICK (Head of Reg. Affairs):
I believe that Avid Bioservices is uniquely positioned in the CDMO industry and offers many clients a perfect opportunity to bring significant development expertise to bear on early development of late stage biomanufacturing projects. In my experience, many biotech companies suffer from the inability to find CDMOs who fully understand their needs, are flexible, and can really deliver products in a timely and high quality manner. Avid is designed and it is now capable of delivering on all of this fronts. This also opens the possibility of bringing Avid's mfg. expertise to bear on potential drug development partnering opportunities as they may arise. This concludes my remarks and I would now like to turn it over to Jeff Hutchins.
JEFF HUTCHINS (VP/PreClinical Res.)
I'm very happy to be able to discuss a number of exciting developments in our preclinical group. First, as Steve discussed, we have executed the licensing agreement with UT Southwestern Medical Center, for novel exosome technology [ 7-14-16: http://tinyurl.com/zszd4fj ] . While many of you are familiar with exosomes, I’ll provide a brief overview for those who are not. Exosomes are cell-secreted vesicles, or mini-cells if you will, that are present in nearly all bodily fluids, including blood. Likewise, tumor-derived exosomes represent small pieces of tumor cells that are released into the blood as tumors grow. As well, these tumor-derived exosomes have Phosphatidylserine or PS on their surface as a marker and can also contain DNA, RNA and proteins as markers of malignant disease. It is believed that even small tumors begin to release PS-positive exosomes, and thus the ability to detect these exosomes in the blood may be an indicator of presence or progression of a tumor. The licensed technology is designed to detect & monitor PS-positive exosomes in a patient's blood sample, providing clinicians with detection & monitoring information regarding the presence & prevalence of cancer. These exosomes have PS flipped to the outside of the surface and demonstrate immunosuppressive activity, just as we find with tumor cells. Preliminary studies have demonstrated that the levels of PS-positive exosomes present in the blood of cancer patients are higher than levels found in the blood of healthy volunteers. Furthermore, study findings also suggest that there is a correlation between the level of PS-positive exosomes that are detected in the blood of cancer patients and the severity or extent of their disease burden. Given our in-house expertise in PS-targeting, we believe that we are uniquely qualified to advance this technology. As Steve stated, there are significant opportunities to use this technology as both a complimentary tool in bavituximab's ongoing development, which Joe will address later, as well as more broadly as the basis for a novel cancer detection & monitoring test kit that will be the focus of our partnering efforts. It is our goal to develop, optimize, and validate a functional detection & monitoring assay capable of detecting PS-positive exosomes from a simple blood sample, and, given the company's extensive experience in developing assays of this type, we do not anticipate the need for added personnel or any specialized equipment for this project. Once we have successfully validated this assay, we plan to establish proof-of-concept through an efficient preclinical & clinical testing program. We have no intention of conducting further development work beyond the proof-of-concept stage. Rather, we expect to initiate partnering discussions for commercialization of this program in 2017. We're very excited to begin this work on this new program and we'll have more details to offer in the coming months.
I'd now like to provide an update on Peregrine's preclinical I-O focused collaboration with Memorial Sloan Kettering Cancer Center. Our goal of this collaboration is to evaluate combinations of bavituximab with other checkpoint inhibitors & immune stimulatory agents for the purpose of developing new & increasingly effective anticancer treatments. This program is advancing well and to-date we have seen initial signs of activity with new combinations with bavituximab and other treatment modalities such as checkpoint blockers, T-Cell agonists, and radiation. Our plan is to spend this next year investigating these potential combinations and we understand that initial results from this collaboration will be presented at scientific conferences later in the year. This concludes my comments and I will turn the call over to Joe Shan.
JOE SHAN (VP/Clin.&Reg. Affairs) – CLINICAL TRIALS:
I'd first like to comment on our new exosome program. One of the most exciting aspects of this technology is the potential synergy that it offers with our bavituximab clinical dev. program. Through our ongoing work with bavituximab, we have gained significant understanding of PS-mediated immuno-suppression in cancer. The availability of the PS specific biomarker, which can be implemented in our planned future bavituximab clinical trials, aligns nicely with our refocused bavituximab dev. strategy aimed at generating the most meaningful data possible from small, early stage clinical trials to support partnering efforts. We are very anxious to bring this new technology to Peregrine and we look forward to the value it brings to our bavituximab program.
Let me now provide a brief update on the Phase III SUNRISE trial. At present, we are continuing to conduct a thorough evaluation of the available clinical data and are testing the numerous biomarker samples collected in order to determine if certain subgroups or patients with other characteristics benefited more from bavituximab treatment. We believe such information could be critical in helping guide the bavituximab clinical program, including our collaborations with NCCN, AstraZeneca and other clinical collaborators. Meanwhile, we continue to collect addl. data even as the trial winds down over the coming months. It is important to remember that at the time of patient unblinding, those who are still receiving steady treatment were given the option of completing the chemotherapy, and those patients assigned to the bavituximab arm were given the option to continue receiving bavituximab if the investigators believed it is in the patient's best interest. Because I-O agents can illicit delayed responses and prolonged survival, we are continuing to follow these patients to evaluate their outcomes. Such information may inform future decisions for the company, and it's our plan to present our findings from the SUNRISE trial when the evaluation is complete. Looking ahead, our priority is to generate clinical evidence of bavituximab's ability to improve patient outcomes when combined with immune-stimulating therapies. We believe our collaborations with the NCCN will play an important role in achieving this goal. The purpose of this collaboration is to expand the company's ongoing clinical research & dev. of bavituximab for the treatment of a range of tumors. I'm pleased to report that the NCCN research collaboration is advancing according to plan, and selected trials are expected to be initiated by the end of calendar 2016 or early 2017. That concludes my comments today. Let me turn the call now over to all Paul Lytle.
PAUL LYTLE (CFO):
We're pleased to report that our mfg. operations continues to experience substantial revenue growth, with a 5-year compounded annual growth rate of 39%, and yr-over-yr growth of 66%. And it's also important to note that this revenue was entirely derived from our Franklin facility, which is our 1st mfg. facility. Looking ahead, we have positioned the company for continued revenue growth with a launch of our 2nd mfg. facility [“Myford”] that was commissioned in March 2016 [3-7-16: http://tinyurl.com/za2j9mt ]. With these 2 operational facilities, we are projecting mfg. revenue of $50-55mm for FY2017. And this projection is supported by current revenue backlog of $68mm under committed contracts, covering services to be completed during this FY2017 and into FY2018. Now turning to Q4/FY'16, we generated contract mfg. revenue of $18.8mm, representing a 102% increase in revenue compared to the same prior year qtr., and for FY2016, we generated mfg. revenue of $44.4mm. Our corporate goal of reaching profitability in 24mos., it is critical that we continue to grow our contract mfg. business. For this reason, and coupled with the high demand for mfg. services, we are planning to construct a 3rd mfg. facility, focused on product & clinical development. We believe this 3rd mfg. facility will again significantly increase our mfg. Capacity, and all 3 facilities will have the potential to generate in total approx. $110mm in annual revenues. As we execute on our plans, we execute a 25,000sf building in close proximity to our current campus and we expect a new clinical suite to be complete and ready for clinical mfg. activities by mid-2017.
Now, turning to expenses, cost of contract mfg. increased during the current qtr and FY in relation to the increase in revenue. In addition, we saw our R&D expenses for FY2016 increase to $59.5mm or +38% compared to FY2015. This expected increase was primarily due to increased mfg. costs associated with preparing bavituximab for commercial production, combined with the increased cost associated with the Phase III SUNRISE trial and the 2 previously planned Phase III trials in breast & lung cancers. As we look ahead, our R&D strategy has changed. We are focusing our internal drug development efforts on small, cost effective, early phase clinical trials designed to attract potential partners to further advance our products. We believe this strategy will not only help us achieve probability sooner, but it will also create significant potential upside for our shareholders. As we execute on the strategy, our goal is to reduce spending by approx. 50% this year in R&D. With that being said, it's important to highlight that we will continue to incur significant costs this FY to wrap up the Phase III SUNRISE trial and to analyze the underlying data. This is an extremely important endeavor that potentially helps us drive both each of partnering interest and our future dev. plans. Turning to G&A expenses, we saw a slight decline in G&A qtr-over-qtr, while G&A remained relatively flat yr-over-yr, decreasing 1%. A more detailed analysis of our state of operations is included in our Form 10K that will be filed later today [ http://tinyurl.com/zgognwz ].
CEO STEVE KING – FURTHER COMMENTS:
It is our goal today to convey the progress that we're making in each area of our business. Our contract mfg. business is thriving and growing and we are projecting record revenues between $50mm & $55mm for next year. We also plan to open a new clinical bioprocessing facility in 2017 that we expect will further extend our revenue potential for the Avid business. Our collaborations are advancing, setting the stage to generate considerable amounts of biomarker, translational, and clinical data. The goal of these studies is to demonstrate the bavituximab mechanism of action in combination treatment settings and attract partnering opportunities. And lastly, we've in-licensed a new exosome technology for a minimal cost that leverages our existing in-house expertise and provides us with another opportunity for us to create value to product development. Together, we believe the strategy will provide success, as it will allow us to focus the majority of our resources on achieving our primary corporate goal, future sustainable profitability within 24 months. At same time, we will focus our R&D efforts on small early stage trials and development of the exosome technology in an effort to attract partners. We believe this strategy will allow us to build near-term revenues through Avid, while maintaining the potential for significant additional value creation associated with our R&D efforts. This concludes our prepared remarks, and we'd now like to open the line for questions.
Q&A: [beg. 23:50]
1. Joe Pantginis – Roth Capital Partners: [ http://www.roth.com & https://roth2.bluematrix.com/docs/pdf/BLUE.pdf ]
JP: ”On the Exosome program, how might it be differentiated from other cancer diagnostics? Secondly, if I heard Jeff correctly, there are some exosomes that are PS expressing in normal individuals. What work might be needed to identify relevant thresholds, or has that been done already.”
Jeff Hutchins: On your 2nd question, we have looked at normal individuals, it’s really a low incidence and certainly we know from our other R&D work that there are PS-positive exosomes in viral infections. Whether that has to be in acute infection that's blood borne is another issue. So, we're looking at that possibility, understanding that they are going to be interferences and false positives, but I think what we’re really impressed around is really the false negative rate at this point, and so that’s where we want to make sure we don’t deliver the wrong message to the patient with an assay like this.
Steve King: To extend on that, so I think what made this attractive is of course that PS is the target for our lead clinical compound bavituximab, so we had really a large amount of knowledge in targeting this molecule and agents that bind to it and so it really fit into our wheel house. And the fact that it goes after the same target as we're targeting with bavituximab gives it that potential of really adding to the clinical program as a potential sort of like a liquid biopsy that would allow you to test blood samples for potentially the presence of your target and then correlate that with patient outcome. That's going to take some work to do in upcoming studies and we’re evaluating what we can do with samples that have already been collected, but that makes it attractive in and of itself. From a standalone development, what drew us to this technology was just really how clean it has been in the ability to differentiate between healthy individuals and those with various stages of cancer. And as Jeff said, so far the false negative & positive rates have been pretty outstanding. So it’s work in progress, again it fits right in; we’re not having to hire addl. people, we’re not having to bring in addl. equipment. This really fits in with everything we are doing on both studying PS, as well as on the assay development side of the business. We think it’s actually going to be complementary. There are other technologies out there looking at exosomes; they're are all taking a very different approach to what we’re doing and we actually think they could be very complementary to each other. We also see a need, even as interest in exosomes begins to pick up, to actually utilize this in conjunction with other things that are in development.
JP: ”Regarding Avid III, how will the size of this facility relate to the other ones and that are currently in place obviously and what kind of costsyou’re looking at to bring it up to speed?”
Steve King: It will be a smaller facility, really geared towards clinical stage products. So, we don’t need as many, if you will, bells & whistles, that go along with it - that helps save a lot of space. So the construction costs we expect to be much less than, for instance, the Myford facility which was the commercial facility we recently commissioned. I think the good news here is that already have a backlog of business to go into that facility. It’s going to allow us, we think, to capture even more business over the coming months as we finish up the facility and can bring customers into what will be, if you will, kind of like a miniature version of our commercial facility we just commissioned, so that they can come in, they can be in the same equipment and as they advance through clinical dev. toward commercialization, we could then transition them over actually to one of our commercial facilities. So, it creates a lot of continuity for the customers coming in, and it’s already received a lot of interest. We’re excited about it getting it up and running.
JP: ”On SUNRISE, you guys mentioned that patients are still able to receive bavituximab. Since patients are still on drug, are you getting anecdotes from physicians that you are seeing some longer term survival based on the potential immunotherapy tail?”
Joe Shan: The data is continuing to come in and I think it's a reasonable conclusion that there are obviously patients that are on therapy a long time. We're right now focused on trying to identify characteristics of those patients that are benefiting the most from Bavi, and I think the biomarker analysis is really going to help provide a lot more clarity & information. We anticipate some results pretty soon.
2. Kumar Raja - Noble Life Science Partners http://noblelsp.com/research
KR: ”Are there any differences in PS expression in various cancers, especially the magnitude, like are there some cancers that you have higher expression compared to others? Also [on the Exosomes licensing], is there already existing IP on this or do you need to file a patent on this technology?”
Steve King: It’s always been a bit of an open question what you asked. It's a good question, because you can’t just take tumor out and sort of slice it and then a look at what’s inside the tumor because there’s PS inside of every cell. So, you temd to get a lot of background when you try to do histological analysis and what have you. We are hopeful that we can actuall,y utilizing this new test, be able to monitor through blood samples actually how much overall PS positive micro particles and tumor cells are there throughout the patient. And that could really be a big benefit in correlating that with which patients do well and which patients don’t do well. At this point I think it remains an open question, but we think this could be actually very nice tool to use in conjunction with that. That's one of our key goals is to be able now implement this in our own clinical studies and get firsthand knowledge of the overall magnitude of PS exposure and how that relates to, actually not just bavituximab treatment, but also other I-O agents. One important thing to keep in mind is that PS positive micro particles are immunosuppressive, so there actually could be a nice correlation between this particular blood marker and outcome on other treatments as well, because they may really portend to a more immunosuppressive environment in those negative patients that don’t do as well for instance. So, we see a lot of utility for this and we think it’s just can really be used in conjunction with a lot of different types of tumors as well as different treatment modalities.
Jeff Hutchins: And filed IP is included in the Univ. of Texas license that we recently put together. [U.S. Patent App# 20150241431 http://tinyurl.com/jtgqfes ]
KR: ”On the Memorial Sloan combination trials, are there any specific combinations that you’re seeing increased response vs. others?”
Steve King: We’re seeing good activity in combination with multiple different types of reagents. Obviously, we are very interested in I-O agents, but it does extend beyond that as well to combinations with, not just in PD-1/PD-L1s, but also agonists, as well as antagonists. In addition, a lot of interest in combinations with things like radiation - radiation almost acts like an adjuvant and so that’s an attractive combination. I think across the board, they haven’t really zeroed in on one particular area that is outshining the others at this point, but as we go on certainly the hope is we will see those combinations that are really just pop and give us the best results.
Jeff Hutchins: To extend that, what we are seeing, and early our contention was, is that PS targeting agents really operate outside of these downstream kind of checkpoint inhibitors. The evidence that we’re seeing with such varied & breadth of combination responses reinforces that idea that we are really affecting an immune suppressive element and reversing that really helps out benefits these other type of approaches whether it’s T-Cell agonist or checkpoint inhibitor or presenting antigen with radiation therapy.
3. Thomas Yip (FBR & Co.): http://www.fbr.com
TY: ”Congratulations on a very impressive qtr from Avid and also on your newly acquired Exosome Technology as well. Re: your Exosome technology, you’ve set a timeline of within 18mos to generate significant value from this program. I'm assuming that means the end game is to out-license... Can you outline for us the key steps that needed within 18mos to reach that goal?”
Steve King: Yes, short term goals, and actually we're already been working on this. Keep in mind that we do have a research collaboration with UT Southwestern, so we didn’t just start looking at this technology this morning; we've been working on for quite some time. Again, it's such a nice fit with what we do already because we already in-house have a lot of PS finding agents that we’ve evaluated, so we already had a lot of the base raw materials to work with. Right now the primary goal is to optimize the assay to achieve the best sensitivity that we can as we go into testing patient samples. So, a lot of work on just designing, the format of the assay, so that we can have a lowest noise and be able to detect levels of PS Exosomes in patients. The next step will be to validate that through patient samples. The beauty of this is that while you do need IRB approval of course, you’re not running really clinical trials, so this can be done in conjunction with either our ongoing trials or partners' trials, or there are many other sources of just receiving these types of blood samples. This gives us the ability to very quickly go through and test hundreds or thousands of patient samples as part of the validation process. At that point, we can zero in on what are the potential applications of the technology, outside of what we might do with our own PS Targeting programs – what would be the potential utility of this for patients. Our goal is not to become a diagnostics company, but to put this in the hands of a good organization that's already established in the diagnostics area and then have them finish up the commercialization and expansion of the utility of the actual assay itself. Our benefit at that point would become, hopefully, some residual royalties, milestones and what have you, which feeds back into our revenue goals of becoming profitable. So, we thought that this is a very attractive technology that just fits right in with what we’re doing and requires almost no additional resources whatsoever.
TY: ”Re: the preliminary data that you already have for exosome, will there be a formal presentation sometime this year or when should we expect to see more preclinical data on this front?”
Steve King: Our goal is, probably towards for the end of this year, to be in a position to have data that we can present. That will come in a lot of different formats, so it will be in conjunction with other ongoing studies that maybe taking place already to be standalone just on the diagnostic itself. So, you'll be hearing a lot about this, and one of the reasons when to get this news out there is because what you think sooner than later we will build a talk about this technology.
TY: ”I just want to confirm that we should expect R&D in FY'17 to be lower, and will the staff count for the new Avid facility ramp up?”
Paul Lytle: Our goal is to basically take R&D spending from FY'16 and reduce it by 50%. All the activities that are related to our mfg. operations go into COG or G&A type expenses, but our goal of this new approach of running smaller earlier stage proof-of-concept type trials is to build value in the program and we think we can do that and reduce our spending by 50% this year.
Steve King: It's important that in that reduction, wrapping up SUNRISE which has been a significant portion of the R&D budget. As that wraps up and we close out the databases and get final data from the study, then you'll probably get a little bit more true view of what we expect the R&D spend to be. The goal here is really different types of studies - they can certainly answer very critical questions, running those in conjunction with our partners, generate data that will then bring on that marketing partner that can really help bear the burden going through into finishing up and into commercialization. As we wrap up SUNRISE, you'll see our R&D expenditures really significantly go down and then it'll be a little bit more of a steady state after that.
4. George Zavoico – Jones Trading http://jonestrading.com
GZ: ”I notice that you’re now calling Avid a CDMO rather than a CMO, which is distinctive and Rob certainly alluded to that. Do you see this as adding addl. value to clients? Is it an add on that you would then put an addl. premium cost to it, rather than just providing API? How are you going to leverage that CDMO?”
Steve King: “CDMO” is a relatively recent term that's has been used by a number of organizations that offer more than mfg. services. In our case, it's really quite broad, because we do have drug dev. experience, we have the ability to do regulatory filings, regulatory document preparation. Really, top to bottom, we, from the CMC side especially, have the ability to basically almost be their entire mfg. arm. That's really where the customers are seeing the value - we're not just offering a service and they tell us what to do and we do it, but we actually get to add a lot of value along the way through our knowledge of what the regulatory bodies expect, both in the U.S. & abroad. Over the long run this is going to end up being opportunities for not just services, but actually for partnering, because this is a service and these are capabilities that almost no small companies have that we have a lot of experience with. I see this as a phenomenal opportunity to continue to expand the business well beyond just bulk drug substance into a lot of different areas of development.
Rob Garnick: Good point Steve. We have a lot of expertise and [????], which are very complicated and something that most more drug development companies who might enjoy such an opportunity would have very little experience with. And so by bringing & leveraging our analytical, our manufacturing and regulatory capabilities, this is really kind of unique. I think most companies would really like to take advantage of that because it allows them to leapfrog their competition and bring their drugs to market much earlier. I really think we’re in a fantastic position with respect to that and as Steve said, some of these companies who are flush with money, and yet don’t have this expertise, might well want to consider a partnering opportunity as a way of speeding up & financing the drug's development.
Steve King: In conjunction with that, when we think about expanding our offerings, its most than just new drug substance facilities, but also could extend into small fill/finish to help out our clinical stage customers with their needs. It could extend eventually even into things like antibody drug conjugates, which is something we have a lot of in-house expertise working on. So, there’s a lot of opportunity here where we see market need from our existing clients, and they’re actually having trouble finding the services that they so desperately need. We see a lot of opportunity, and it’s all based on demand from customers saying, can you do this, and I think that’s really the exciting part. We're not building things we're hoping people come to, but things that people are already asking us for.
GZ: ”The only thing you didn’t provide yet is fill/finish. Are you making room in your new 3rd facility to perhaps provide that service?”
Steve King: Yes, we’re looking at that as part of the new facility, particularly for clinical stage products, because we see it as such a big burden on the clients - they got to arrange runs with us and we’ve got to release this and they've got to have a spot open, and if there's any sort of movement of the timelines, it's a real hassle for them. So, we think that will be a major draw for actually bringing in new business. Our goal for the new facility is, it's almost like the funnel that leads into our commercial facilities, which is where we can make a lot of revenue progress. So, basically feed as many people into clinical, so we get those coming through that are successful into the commercial facilities and that really we think is the key to growing a long-term successful business. So yes, fill/finish is definitely high on the list, and this is just because our clients are just clamoring for something that would be much easier for them to manage.
GZ: ”So, you'll be doing development consulting services, and some of the expertise doesn't really lie in Avid, it lies in Peregrine. So that means that Rob, Jeff, Joe will be going back & forth across the 2 divisions of the company as needed. Is that correct?”
Steve King: Absolutely, that’s already happening. We're finding that we have so much expertise across the board, and the customers have reacted very positively to having that additional expertise available, because either they have it in-house, and a lot of them just don’t have that particular expertise in-house, so they have to go out and hire a consultant - it’s easier for them if they can work with a one-stop-shop that provides them with everything they need, and then they can to limit the number of different groups they have to work with.
GZ: ”Sometimes it’s better just to get another opinion on a question that needs answering in the mfg. process.”
Steve King: Yes, true. The biggest thing that sets us apart is our knowledge of the regulatory bodies and what their expectations are. In particular, that’s a huge benefit for the clients as they're making process changes or filings overseas - it’s an area where we can help them out a lot.
GZ: ”Re: Exosomes. 1St, can you say what you're budgeting for that? 2nd, you've already done imaging of PS for many years now with florescent or otherwise tagged Bavituximab antibodies. Is this exosomes technology antibody based? Finally, you’re entering a rather competitive and very interesting space for liquid biopsies - do you see this competing or being supplementary to measuring circulating T-cells or circulating tumor DNA?”
Steve King: Yes, we see this as being very complementary to other technologies that are being developed; that's one of the things that made it very attractive. I think the ease of collecting samples would put it way ahead of an imaging agent, because those by their very nature you've got to put something in, take scans - long days for the patient, where this is a simple blood draw from a patient perspective and then the results come in. We see this as a very interesting space, just because we know that the PS exosomes are going to be immunosuppressive. So, the ability to correlate this with overall immune status of patients - there is a lot of utility of the technology we think that can be brought to bear, not just for Bavituximab, but for a lot of other I-O type technologies. We think it could be very nice to pair that up with the other types of analysis that are being done - T-cells or other emulator cells or even T-rigs, and how do they correlate with this simple test.
GZ: ”Then, is it antibody based or come in with a budget if you can.”
Steve King: We can't really say at this point, because we want to make sure we get perfect amount of protection around it. As you know we have all kinds of agents to bind the PS. We’ve got betabodies, we’ve got antibodies, we’ve got all kinds of things that bind to PS. The beauty of this technology is that we understand it really well, because we've already studied it, we've already made all the agents. And so I think we're in a great position to really quickly move this forward to proof of concept.
5. FOLLOWUP: Joe Pantginis – Roth Capital Partners:
JP: ”Re: Avid's Gross Margins - is this something that you think you can improve upon as your facilities expand?”
Paul Lytle: Our GM's for FY15 was ~42%, and FY16 improved to 48%. It really depends on the mix of services and the mix of activities that are currently ongoing. I can say that our new micro facility does have a slightly higher COGS because we've got an asset there that needs to be depreciated every month, which contributes to the COGS of that facility, whereas our pre-existing Franklin facility has been fully depreciated for some time. Our goal overall is to maximize our GM's from this business, and we're really geared towards doing that. Other than that, we really can't predict what the COGS will be, because it's really based on the mix of services within that facility.
MR. KING’S CLOSING COMMENTS:
I’d like to thank you all once again for participating in today's phone call. As always I want to thank our stockholders for their continued support and I would like to especially thank our patients, their families and the investigators that are precipitating in bavituximab clinical trials. With that, we will now conclude the call. Thank you.
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7-14-15 PR: Peregrine Pharmaceuticals Reports Financial Results for Quarter and Fiscal Year Ended April 30, 2016 and Recent Developments
-- Avid Contract Manufacturing Revenues Increased 66% to $44.4 Million with a Revenue Backlog of $68 Million Heading into Fiscal Year 2017
-- Growing Biomanufacturing Demand Prompts Plans for Third Manufacturing Facility Expected to be Commissioned by mid-2017
-- Analysis of Data from SUNRISE Phase III Trial Ongoing with New Clinical Trials Expected to Commence Late 2016 to Early 2017
-- Novel PS-Exosome Technology In-Licensed for Cancer Detection and Monitoring
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=979668
TUSTIN, July 14, 2016: Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM/PPHMP), a biopharmaceutical company committed to improving patient lives by delivering high quality biological products through its contract development and manufacturing organization (CDMO) services and by advancing its novel R&D pipeline, today announced financial results for the fourth quarter and fiscal year (FY) ended April 30, 2016, and provided an update on its contract manufacturing business, clinical pipeline and other corporate developments.
HIGHLIGHTS SINCE JANUARY 31, 2016
"Peregrine's business strategy is to focus the company's resources primarily on continuing to grow its biomanufacturing business while advancing R&D efforts through small, proof of concept clinical trials and the development of new technologies. Together, this will allow Peregrine to reach profitability, increase shareholder value by steadily increasing the worth of the company's established CDMO business, and retain significant upside potential from bavituximab and other R&D programs," stated Steven W. King, President and CEO of Peregrine. "Over the past year, the company has taken huge strides toward future revenue growth, including the commissioning of a new commercial facility which is already completely booked into early next year with potential new commercial projects. The facility has the potential to generate over $40 million in revenue at full capacity during commercial production. The company continues to see such a high demand for additional manufacturing capacity and in response, has already begun designing a new facility for clinical stage products that could eventually transfer into one of our commercial production facilities. We expect this new facility to be commissioned by the middle of 2017, and there is already a backlog of existing business earmarked for the new facility. The company expects the continued growth of its manufacturing revenues at these new facilities, as well as the potential addition of new capabilities, to be a major driver toward consistent overall profitability."
Mr. King continued, "Concurrent with growing its manufacturing business, Peregrine will continue to leverage its phosphatidylserine (PS)-targeting platform in two ways. First the company will continue to extract critical data from the SUNRISE Phase III trial that can be instrumental in guiding the advancement of bavituximab in combination with immune stimulating therapies. In addition, the company announced earlier today that it has signed a license agreement with its long-term collaborator, UT Southwestern Medical Center, for a novel PS-exosome technology with the potential to detect and monitor cancer at an early stage through a simple blood test. Given the company's tremendous knowledge base in targeting PS and its infrastructure for developing and validating tests for biologic samples, Peregrine is uniquely positioned to advance this technology. The company believes that, for a modest capital investment, it can quickly reach proof of concept with a goal of partnering the technology with an established diagnostics company. Overall, Peregrine believes this strategy will allow the company to continue its research and development activities with significant upside coming from partnering as it moves toward profitability."
AVID BIOSERVICES HIGHLIGHTS
"The company's manufacturing business has experienced substantial revenue growth over the past several fiscal years with a 5-year compounded annual growth rate of 39% and year-over-year growth of 66%. In addition, this revenue growth came entirely from Avid's first manufacturing facility and the company is positioned for continued revenue growth with the launch of its second manufacturing facility that became fully operational in March 2016," stated Paul Lytle, CFO of Peregrine. "With these two operational facilities, the company is projecting manufacturing revenue of $50 to $55 million for fiscal year 2017 that is supported by a current revenue backlog of $68 million under committed contracts."
On June 2, 2016, the company announced the goal of achieving overall future sustained profitability in 24 months.
The company is projecting manufacturing revenue for FY 2017 of $50 - $55 million.
Avid's current manufacturing revenue backlog is $68 million, representing estimated future manufacturing revenue to be recognized under committed contracts. This backlog covers revenue to be recognized in fiscal year 2017 and into fiscal year 2018.
In March 2016, the company formally commissioned its new, state-of-the-art biomanufacturing facility (Myford facility) [3-7-16/PR: http://tinyurl.com/za2j9mt ]. The Myford facility is designed to utilize the most cutting-edge, single-use equipment to accommodate a fully disposable biomanufacturing process for late Phase III clinical and commercial production of biologics. The facility was designed to operate in commercial campaign mode whereby multiple bioreactors are simultaneously in operation, which more than doubles the facility's manufacturing capacity.
The recently commissioned Myford facility [“Avid II”] has completed an initial process validation campaign with a second process validation underway and two more planned for later this year.
In response to demand for manufacturing services, the company is now designing a third manufacturing facility dedicated to clinical manufacturing that is anticipated to significantly increase Avid's manufacturing capacity. The new clinical suite is expected to be complete and ready for clinical manufacturing activities by mid-2017.
CLINICAL DEVELOPMENT HIGHLIGHTS
SUNRISE Phase III Trial - Peregrine is currently conducting an extensive review and analysis of the available clinical data and testing the numerous collected biomarker samples in order to determine if certain subgroups or patients with other characteristics benefited more from bavituximab treatment. The company believes such information could be critical in helping guide the bavituximab clinical program including its collaborations with the National Comprehensive Cancer Network (NCCN), AstraZeneca, and other clinical collaborators.
Going forward, Peregrine's clinical development strategy is to focus on small, early stage proof of concept trials with other immune stimulating therapies. The intent behind this strategy is to control research and development costs, while continuing to generate clinical data to further validate bavituximab's combination potential that will be critical to bringing onboard a partner to help advance the program.
As part of this clinical strategy, Peregrine's research collaboration with the NCCN is advancing as planned. The purpose of this collaboration is to expand the company's ongoing clinical research and development of bavituximab for the treatment of a range of tumors. Selected trials are expected to be initiated by the end of calendar 2016, or early 2017.
EXOSOME PROGRAM [ See 7-14-16/PR: http://tinyurl.com/zszd4fj ]
Peregrine in-licensed a novel exosome technology from the UT Southwestern that has potential for cancer detection and monitoring applications.
This technology aligns directly with the company's expertise, its proprietary PS-targeting platform and the bavituximab development program. As such, there are opportunities to use this technology as both a complementary tool in bavituximab's ongoing development, as well as more broadly as the basis for novel cancer detection and monitoring tests that can be the focus of partnering efforts.
The licensed technology is designed to detect PS-positive exosomes within the blood. These exosomes are highly immunosuppressive, which is consistent with the immunosuppression that is often seen in tumor microenvironments.
Preliminary studies have provided evidence that the levels of PS-positive exosomes present in the blood of cancer patients are higher than levels found in the blood of healthy volunteers. Furthermore, study findings also suggest that there is a correlation between the level of PS-positive exosomes detected in the blood of cancer patients and the severity of disease burden.
Peregrine has the existing infrastructure, staff and expertise to develop, optimize and validate testing methodologies for detecting PS-positive exosomes in blood samples. The company expects to secure a partner to develop the final commercial test kit.
SUPPORTIVE RESEARCH HIGHLIGHTS
Peregrine plans to continue conducting pre-clinical and translational studies to support ongoing and future clinical development activities. The goal of these studies will be to generate compelling translational biomarker data that inform the selection of treatment combinations featuring bavituximab. The company believes that data from these studies will be important for partnering bavituximab.
Positive results presented at the 2016 American Association for Cancer Research (AACR) Annual Meeting [4-20-16: http://tinyurl.com/jyox458 ] provided further support for Peregrine's strategy of evaluating bavituximab in combination with a range of novel immuno-oncology (I-O) agents for the treatment of various cancers. The presentation of preclinical study data demonstrated enhanced anti-tumor activity and immune activation for a combination of the preclinical bavituximab equivalent (ch1N11) and anti-PD-1 therapy in models of breast cancer, including triple negative breast cancer (TNBC).
FINANCIAL RESULTS
Total revenues for the fourth quarter FY 2016 were $18,783,000, compared to $9,308,000 for the same quarter of the prior fiscal year. For FY 2016, total revenues were $44,686,000, compared to $26,781,000 for the prior fiscal year. The fourth quarter and fiscal year 2016 increases were attributed to an increase in contract manufacturing revenue.
Contract manufacturing revenue from Avid's clinical and commercial biomanufacturing services provided to its third-party clients increased 102% to $18,783,000 for the fourth quarter of FY 2016 compared to $9,308,000 for the fourth quarter of FY 2015 and increased 66% to $44,357,000 for FY 2016 compared to $26,744,000 for FY 2015. The fourth quarter and fiscal year increases were primarily attributed to an increase in demand for contract manufacturing services. Current contract manufacturing commitments from Avid's third-party customers are approximately $68 million, covering services to be provided during FY 2017 and into FY 2018. Based on this current backlog, Peregrine expects contract manufacturing revenue for FY 2017 to be between $50 and $55 million.
Total costs and expenses for the fourth quarter of FY 2016 were $30,698,000, compared to $21,477,000 for the fourth quarter of FY 2015. For FY 2016, total costs and expenses were $101,046,000 compared to $77,280,000 for FY 2015. These increases for both fourth quarter and fiscal year 2016 were primarily attributable to an increase in research and development expenses associated with the Phase III SUNRISE trial, the clinical costs associated with two previously planned phase II trials, and higher manufacturing costs related to preparing bavituximab for commercial manufacturing. For the fourth quarter of FY 2016, research and development expenses were $16,265,000, compared to $11,531,000 for the fourth quarter of FY 2015, and for FY 2016 were $59,529,000 compared to $42,996,000 for FY 2015. In addition, cost of contract manufacturing increased 104% to $9,721,000 and 47% to $22,966,000 for the fourth quarter of FY 2016 and full FY 2016, respectively, primarily due to higher reported revenue compared to the same prior year periods. For the fourth quarter of FY 2016, selling, general and administrative expenses were $4,712,000, compared to $5,188,000 for the fourth quarter of FY 2015 and for FY 2016 were $18,551,000 compared to $18,691,000 for FY 2015.
Peregrine's consolidated net loss attributable to common stockholders was $13,264,000 or $0.05 per share, for the fourth quarter of FY 2016, compared to a net loss attributable to common stockholders of $13,513,000, or $0.07 per share, for the same prior year quarter. For FY 2016, net loss attributable to common stockholders was $60,136,000, or $0.28 per share, compared to $54,054,000, or $0.30 per share, for FY 2015.
Peregrine reported $61,412,000 in cash and cash equivalents as of April 30, 2016, compared to $68,001,000 at fiscal year ended April 30, 2015.
More detailed financial information and analysis may be found in Peregrine's Annual Report on Form 10-K, which will be filed with the Securities and Exchange Commission today. [ http://tinyurl.com/zgognwz ]
CONFERENCE CALL
Peregrine will host a conference call and webcast this afternoon, July 14, 2016, at 4:30 PM EDT (1:30 PM PDT). To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Peregrine Pharmaceuticals conference call. To listen to the live webcast, or access the archived webcast, please visit: http://ir.peregrineinc.com/events.cfm .
ABOUT PEREGRINE PHARMACEUTICALS, INC.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of patients by delivering high quality pharmaceutical products through its contract development and manufacturing organization (CDMO) services and through advancing and licensing its investigational immunotherapy and related products. Peregrine's in-house CDMO services, including cGMP manufacturing and development capabilities, are provided 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. The company is also working to evaluate its lead immunotherapy candidate, bavituximab, in combination with immune stimulating therapies for the treatment of various cancers, and developing its proprietary exosome technology for the detection and monitoring of cancer. For more information, please visit http://www.peregrineinc.com .
ABOUT AVID BIOSERVICES
Avid Bioservices provides a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With over 15 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, Avid's services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support. The company also provides a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. For more information about Avid, please visit http://www.avidbio.com .
Safe Harbor *snip*
PEREGRINE PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
AS OF APRIL 30, 2016 AND 2015
2016 2015
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 61,412,000 $ 68,001,000
Trade and other receivables, net 2,859,000 3,813,000
Inventories 16,186,000 7,354,000
Prepaid expenses and other current assets, net 1,351,000 1,355,000
Total current assets 81,808,000 80,523,000
PROPERTY AND EQUIPMENT:
Leasehold improvements 19,610,000 1,538,000
Laboratory equipment 10,257,000 5,965,000
Furniture, fixtures, office equipment and software 4,045,000 3,991,000
Construction-in-progress - 11,819,000
33,912,000 23,313,000
Less accumulated depreciation and amortization (9,610,000 ) (8,189,000 )
Property and equipment, net 24,302,000 15,124,000
Restricted cash 600,000 -
Other assets 2,333,000 1,817,000
TOTAL ASSETS $ 109,043,000 $ 97,464,000
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 8,429,000 $ 10,385,000
Accrued clinical trial and related fees 7,594,000 3,910,000
Accrued payroll and related costs 5,821,000 4,606,000
Deferred revenue 10,030,000 6,630,000
Customer deposits 24,212,000 11,363,000
Other current liabilities 1,488,000 437,000
Total current liabilities 57,574,000 37,331,000
Deferred rent, less current portion 1,395,000 1,098,000
Commitments and contingencies
STOCKHOLDERS' EQUITY:
Preferred stock - $.001 par value; authorized 5,000,000 shares;
issued and outstanding - 1,577,440 and 1,574,764, respectively 2,000 2,000
Common stock - $.001 par value; authorized 500,000,000
shares; issued and outstanding - 236,930,485 and 193,346,627,
respectively 237,000 193,000
Additional paid-in-capital 559,111,000 512,464,000
Accumulated deficit (509,276,000 ) (453,624,000 )
Total stockholders' equity 50,074,000 59,035,000
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 109,043,000 $ 97,464,000
PEREGRINE PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
FOR EACH OF THE THREE YEARS IN THE PERIOD ENDED APRIL 30, 2016
2016 2015 2014
REVENUES:
Contract manufacturing revenue $ 44,357,000 $ 26,744,000 $ 22,294,000
License revenue 329,000 37,000 107,000
Total revenues 44,686,000 26,781,000 22,401,000
COSTS AND EXPENSES:
Cost of contract manufacturing 22,966,000 15,593,000 13,110,000
Research and development 59,529,000 42,996,000 27,723,000
Selling, general and administrative 18,551,000 18,691,000 17,274,000
Total costs and expenses 101,046,000 77,280,000 58,107,000
LOSS FROM OPERATIONS (56,360,000 ) (50,499,000 ) (35,706,000 )
OTHER INCOME (EXPENSE):
Interest and other income 722,000 142,000 349,000
Interest and other expense (14,000 ) (1,000 ) (5,000 )
NET LOSS $ (55,652,000 ) $ (50,358,000 ) $ (35,362,000 )
COMPREHENSIVE LOSS $ (55,652,000 ) $ (50,358,000 ) $ (35,362,000 )
Series E preferred stock accumulated
dividends (4,484,000 ) (3,696,000 ) (401,000 )
NET LOSS ATTRIBUTABLE TO
COMMON STOCKHOLDERS $ (60,136,000 ) $ (54,054,000 ) $ (35,763,000 )
WEIGHTED AVERAGE COMMON
SHARES OUTSTANDING:
Basic and Diluted 216,265,620 182,558,332 161,579,649
BASIC AND DILUTED LOSS PER
COMMON SHARE $ (0.28 ) $ (0.30 ) $ (0.22 )
CONTACTS:
• Jay Carlson Peregrine Pharmaceuticals, Inc. 800-987-8256 info@peregrineinc.com
• Stephanie Diaz (Investors) Vida Strategic Partners 415-675-7401 sdiaz@vidasp.com
• Tim Brons (Media) Vida Strategic Partners 415-675-7402 tbrons@vidasp.com
- - - - - - - - -
[ From 10-K header: “As of July 11 2016, there were 241,456,721 shares outstanding.”
- - - - - - - - - - - - - - - - -
Latest 10K 4-30-16 iss. 7-14-16 http://tinyurl.com/zgognwz PR: http://tinyurl.com/h8eqtg5 (Cash 4-30-16=$61.4mm)
Latest 10Q 1-31-16 iss. 3-9-16 http://tinyurl.com/hdgto9y PR: http://tinyurl.com/gom7md5 (Cash 1-31-16=$67.5mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
= = = = = = = = = = = = = = = = = = = = = = = = = = = =
FY'16/Q4(qe 4-30-16) Avid Revs doubled prev.record to $18.8mm; FY16=$44.4mm(+66% yr-over-yr.). GROSS PROFIT Q4=$9.1mm; $21.4mm for FY16 (GM=48%). Guidance for FY17(fye 4-30-17)=$50-55mm. Committed B/L a/o 7-14-16=$68mm. Avid II (Myford) went fully operational 3-2016. (6-2-16/PR: “Myford ramping up for runs for 3 current clients”). Peregrine is in the process of designing a 3rd mfg. facility “focused on clinical manufacturing”; has already secured a 25,000sf location, and “expect this new (3rd Avid) facility to be commissioned by mid-2017; there is already a backlog of existing business earmarked for the new facility.” ...All this leads to Peregrine expecting, "future sustainable profitability for the company in 24 months".
- - - - - - - - - -
Updated PPHM REVS-BY-QTR TABLE, now thru FY16'Q4(fye 4-30-16), per the 4-30-16 10-K ( http://tinyurl.com/zgognwz ) issued 7-14-16.
• Total Revs since May’06: ($173.6mm/Avid + $24.1mm/Govt + $2.5mm/Lic.) = $200.2mm
• 7-14-16: FY'17 (May'16-Apr'17) Avid revs guidance $50-55mm (Committed B/L=$68mm).
• Deferred-Revs at 4-30-16 total $10.0mm, DOWN from $15.4mm at 1-31-16.
• Cust.Deposits at 4-30-16 total $24.2mm, UP from $22.4mm at 1-31-16.
• Inventories at 4-30-16 total $16.2mm, UP from $15.2mm at 1-31-16.
• Avid’s Gross-Profit over last 4 qtrs: $21.4mm on revs of $44.4mm (GP%=48%)
• Recall, Avid Rev$ 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$ GP%
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%
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%
FY15Q1 7-31-14 5,496,000 3,583,000 1,913,000 35%
FY15Q2 10-31-14 6,263,000 4,139,000 2,124,000 34%
FY15Q3 1-31-15 5,677,000 3,113,000 2,564,000 45%
FY15Q4 4-30-15 9,308,000 4,758,000 4,550,000 49%
FY16Q1 7-31-15 9,379,000 4,608,000 4,771,000 51%
FY16Q2 10-31-15 9,523,000 4,741,000 4,782,000 50%
FY16Q3 1-31-16 6,672,000 3,896,000 2,776,000 42%
FY16Q4 4-30-16 18,783,000 9,721,000 9,062,000 48%
FY13 TOTAL: 21,333,000 12,595,000 8,738,000 41%*
FY14 TOTAL: 22,294,000 13,110,000 9,184,000 41%*
FY15 TOTAL: 26,744,000 15,393,000 11,151,000 42%*
FY16 TOTAL: 44,357,000 22,966,000 21,391,000 48%*
*Avid Net-Profit (ie, incl. Selling, G&A) not split out from PPHM-Corp. in the financials.
.
PPHM REVENUES (in thousands) DEFERRED
-------REVENUES------- REVENUES INVEN-
Quarter Avid Govt Lic. TOTAL Avid Govt TORIES
FY07Q1 7-31-06 398 0 23 421 317 0 971
FY07Q2 10-31-06 636 0 48 684 1388 0 1899
FY07Q3 1-31-07 347 0 16 363 2202 0 1325
FY07Q4 4-30-07 2111 0 129 2240 1060 0 1916
FY08Q1 7-31-07 1621 0 4 1625 1820 0 2363
FY08Q2 10-31-07 1863 0 29 1892 1338 0 3500
FY08Q3 1-31-08 1662 0 13 1675 1434 0 2394
FY08Q4 4-30-08 751 0 150 901 2196 0 2900
FY09Q1 7-31-08 1193 324 0 1517 4021 980 4628
FY09Q2 10-31-08 983 958 0 1941 6472 1701 6700
FY09Q3 1-31-09 5778 1048 0 6826 4805 3262 5547
FY09Q4 4-30-09 5009 2683 175 7867 3776 3871 4707
FY10Q1 7-31-09 2070 4671 9 6750 5755 2332 6177
FY10Q2 10-31-09 5308 1510 78 6896 4260 3989 5850
FY10Q3 1-31-10 2945 6854 78 9877 3052 76 3861
FY10Q4 4-30-10 2881 1461 78 4420 2406 78 3123
FY11Q1 7-31-10 983 2111 115 3209 3719 47 4692
FY11Q2 10-31-10 3627 966 78 4671 2447 35 3555
FY11Q3 1-31-11 1922 882 79 2883 4300 40 3915
FY11Q4 4-30-11 1970 681 78 2729 5617 0 5284
FY12Q1 7-31-11 5439 0 216 5655 4145 0 4481
FY12Q2 10-31-11 4154 0 78 4232 2012 0 3178
FY12Q3 1-31-12 3203 0 78 3281 2552 0 2722
FY12Q4 4-30-12 1987 0 78 2065 3651 0 3611
FY13Q1 7-31-12 4135 0 116 4251 6056 0 5744
FY13Q2 10-31-12 6061 0 78 6139 6221 0 5426
FY13Q3 1-31-13 6961 0 78 7039 5061 0 4635
FY13Q4 4-30-13 4176 0 78 4254 4171 0 4339
FY14Q1 7-31-13 4581 0 107 4688 4164 0 5679
FY14Q2 10-31-13 7354 0 0 7354 3468 0 4033
FY14Q3 1-31-14 3885 0 0 3885 4329 0 5224
FY14Q4 4-30-14 6474 0 0 6474 5241 0 5530
FY15Q1 7-31-14 5496 0 0 5496 4670 0 5998
FY15Q2 10-31-14 6263 0 37 6300 3612 0 5379
FY15Q3 1-31-15 5677 0 0 5677 5752 0 6148
FY15Q4 4-30-15 9308 0 0 9308 6630 0 6148
FY16Q1 7-31-15 9379 0 292 9671 8291 0 10457
FY16Q2 10-31-15 9523 0 0 9523 9688 0 12554
FY16Q3 1-31-16 6672 0 37 6709 15418 0 15189
FY16Q4 4-30-16 18783 0 0 18783 15418 0 15189
Totals: 173569 24149 2453 200171 <=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
FY15 4-30-15 26,781 …Avid(CMO)= 26,744
FY16 4-30-16 44,686 …Avid(CMO)= 44,357
...Total Gov’t Revs from 7-2008 inception thru FY11Q1(Apr’11): $24.15mm
.
PPHM’S QTLY. NET LOSS BY QTR:
FY08Q1 7-31-07 4,656,000
FY08Q2 10-31-07 6,207,000
FY08Q3 1-31-08 6,154,000
FY08Q4 4-30-08 6,159,000
FY09Q1 7-31-08 5,086,000
FY09Q2 10-31-08 4,497,000
FY09Q3 1-31-09 3,332,000
FY09Q4 4-30-09 3,609,000
FY10Q1 7-31-09 2,428,000
FY10Q2 10-31-09 2,787,000
FY10Q3 1-31-10 1,538,000
FY10Q4 4-30-10 7,741,000
FY11Q1 7-31-10 7,695,000
FY11Q2 10-31-10 7,513,000
FY11Q3 1-31-11 8,929,000
FY11Q4 4-30-11 10,014,000
FY12Q1 7-31-11 8,092,000
FY12Q2 10-31-11 12,055,000
FY12Q3 1-31-12 11,090,000
FY12Q4 4-30-12 10,882,000
FY13Q1 7-31-12 7,664,000
FY13Q2 10-31-12 8,753,000
FY13Q3 1-31-13 4,914,000
FY13Q4 4-30-13 8,449,000
FY14Q1 7-31-13 7,600,000
FY14Q2 10-31-13 7,790,000
FY14Q3 1-31-14 9,724,000
FY14Q4 4-30-14 10,248,000
FY15Q1 7-31-14 13,129,000
FY15Q2 10-31-14 12,100,000
FY15Q3 1-31-15 12,994,000
FY15Q4 4-30-15 12,135,000
FY16Q1 7-31-15 13,723,000
FY16Q2 10-31-15 13,198,000
FY16Q3 1-31-16 16,847,000
FY16Q4 4-30-16 11,884,000
= = = = = = = =
OPER. CASH BURNS* BY QTR(FROM THE 10-Q/K’S):
FY10Q1 7-31-09 2,024,000 (from 10Q pg.25)
FY10Q2 10-31-09 2,351,000 (Q1+Q2: 4,375,000 pg.28)
FY10Q3 1-31-10 1,158,000 (Q1+Q2+Q3: 5,533,000 pg.30)
FY10Q4 4-30-10 6,375,000 (FY’10: 11,908,000 10K pg.58)
FY11Q1 7-31-10 6,567,000 (from 10Q pg.24)
FY11Q2 10-31-10 6,167,000 (Q1+Q2: $12,734,000 pg.25)
FY11Q3 1-31-11 7,736,000 (Q1+Q2+Q3: $20,470,000 pg.26)
FY11Q4 4-30-11 8,961,000 (FY’11: 29,431,000 10K pg.54)
FY12Q1 7-31-11 6,984,000 (from 10Q pg.25)
FY12Q2 10-31-11 11,668,000 (Q1+Q2: 18,652,000 pg.25)
FY12Q3 1-31-12 8,490,000 (Q1+Q2+Q3: 27,142,000 pg.25)
FY12Q4 4-30-12 11,265,000 (FY’12: 38,407,000 10K pg.55)
FY13Q1 7-31-12 6,742,000 (from 10Q pg.21)
FY13Q2 10-31-12 6,162,000 (Q1+Q2: 12,904,000 pg.23)
FY13Q3 1-31-13 3,597,000 (Q1+Q2+Q3: 16,501,000 pg.23)
FY13Q4 4-30-13 7,053,000 (FY’13: 23,554,000 10K pg.60)
FY14Q1 7-31-13 5,750,000 (from 10Q pg.23)
FY14Q2 10-31-13 5,834,000 (Q1+Q2: 11,584,000 10Q pg.24)
FY14Q3 1-31-14 7,875,000 (Q1+Q2+Q3: 19,459,000 10Q pg.26)
FY14Q4 4-30-14 8,706,000 (FY’14: 28,165,000 10K pg.55)
FY15Q1 7-31-14 11,076,000 (from 10Q pg.23)
FY15Q2 10-31-14 9,947,000 (Q1+Q2: 21,023,000 10Q pg.25)
FY15Q3 1-31-15 11,116,000 (Q1+Q2+Q3: 32,139,000 10Q pg.26)
FY15Q4 4-30-15 10,474,000 (FY’15: 42,613,000 10K pg.54)
FY16Q1 7-31-15 12,306,000 (from 10Q pg.25)
FY16Q2 10-31-15 11,701,000 (Q1+Q2: 24,007,000 10Q pg.26)
FY16Q3 1-31-16 15,086,000 (Q1+Q2+Q3: 39,093,000 10Q pg.27)
FY16Q4 4-30-16 10,112,000 (FY'16: 49,205,000 10K pg.39)
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
FY’15 total Op-Burn: $42,613,000
FY’16 total Op-Burn: $49,205,000
FY/E Halozyme Cust-A/U.S. Other-Custs
4-30-14 91% 1% 8%
4-30-15 79% 12% 9%
4-30-16 69% 26% 5%
7-14-16/PR: Peregrine Licenses Exosome-Based Cancer Detection/Monitoring from UTSW.
...See May'14 J.Immunol.Methods article (below) by Alan Schroit/Philip Thorpe, "A Novel 'Salting-Out' Procedure For The Isolation Of Tumor-Derived Exosomes”.
...Also, see U.S./Intl. Patent App's 20150241431/WO2015131153, filed 2-27-15 at bottom of this post (”Methods & Compositions For Isolating Exosomes”)…
7-14-16: Peregrine Licenses Novel Exosome-Based Cancer Detection and Monitoring Technology from UT Southwestern Medical Center
--New Technology Efficiently Builds on the Company's Existing Phosphatidylserine (PS) Targeting Platform and Assay Development Capabilities
--Stand Alone Program That Offers Significant Value Creation Potential and Early Partnering Opportunities
--New Technology to Also be Evaluated in Conjunction with Ongoing Bavituximab Clinical Development Program
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=979554
TUSTIN, July 14, 2016: Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM/PPHMP), a biopharmaceutical company committed to improving patient lives by delivering high quality biological products through its contract development and manufacturing organization (CDMO) services and by advancing its novel R&D pipeline, today announced that the company has entered into an exclusive licensing agreement with University of Texas (UT) Southwestern Medical Center for a novel exosome technology that has potential application as a simple blood test to detect or monitor cancer. The company intends to develop a novel cancer test utilizing internal expertise and then pursue revenue-generating partnering opportunities at an early stage of development.
Tumor exosomes represent small pieces of tumor cells that are released into the blood as tumors grow. Tumor derived exosomes have phosphatidylserine (PS) on their surface as a detectable marker. It is believed that even small tumors begin to release PS-positive exosomes and thus the ability to detect these exosomes in the blood may be an indicator of the presence of a tumor.
The licensing agreement is the result of the long-standing sponsored research agreement between Peregrine and UT Southwestern focused on PS, a highly immunosuppressive signaling molecule. The new technology licensed by Peregrine relates to assays that are able to detect small amounts of PS-exosomes in a patient blood sample as a way to potentially detect cancer at a very early stage of development. Preliminary studies have demonstrated that the levels of PS-positive exosomes present in the blood of cancer patients are higher than levels found in the blood of healthy volunteers. Furthermore, study findings also suggest that there is a correlation between the level of PS-positive exosomes detected in the blood of cancer patients and disease burden.
"We are excited to enter into this licensing agreement with our long-term collaborators at UT Southwestern. This technology offers a promising product development opportunity and aligns directly with the company's expertise with our proprietary PS-targeting platform and our longstanding CDMO capabilities around the development, qualification, and validation of in vitro analytical assays. As such, there are significant opportunities to use this technology as both a complementary tool in bavituximab's ongoing development, as well as more broadly as the basis for novel cancer detection and monitoring tests that can be the focus of partnering efforts," said Jeff T. Hutchins, Ph.D., Peregrine's VP, Preclinical Research. "It is important to note that this development program will require minimal capital investment and has the potential to create significant value over the next 18 months, including potential partnering opportunities. As a result, we feel that today's licensing deal provides yet another important driver in our ongoing efforts to achieve profitability."
Together, the Peregrine and Avid Bioservices teams have the existing infrastructure, staff and expertise to develop, optimize and validate a functional assay capable of detecting PS-positive exosomes from a blood sample. Given the company's extensive experience in developing assays of this type, Peregrine does not anticipate the need to add personnel or any specialized equipment for this project. The company intends to establish clinical proof-of-concept for the test and expects to initiate partnering discussions for the program in 2017.
"One of the most exciting aspects of this technology is the potential synergy that it offers with our ongoing bavituximab clinical development program. Through our ongoing work with bavituximab, we have gained significant understanding of PS-mediated immunosuppression in cancer," said Joseph Shan, MPH, VP, Clinical & Regulatory Affairs of Peregrine. "The availability of a PS-specific biomarker which can be implemented in our planned future bavituximab clinical trials aligns nicely with our refocused bavituximab development strategy aimed at generating the most meaningful data possible from small, early stage clinical trials to support partnering efforts."
ABOUT PEREGRINE PHARMACEUTICALS, INC.
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of patients by delivering high quality pharmaceutical products through its contract development and manufacturing organization (CDMO) services and through advancing and licensing its investigational immunotherapy and related products. Peregrine's in-house CDMO services, including cGMP manufacturing and development capabilities, are provided 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. The company is also working to evaluate its lead immunotherapy candidate, bavituximab, in combination with immune stimulating therapies for the treatment of various cancers, and developing its proprietary exosome technology for the detection and monitoring of cancer. For more information, please visit http://www.peregrineinc.com .
Safe Harbor *snip*
Contacts: Jay Carlson Peregrine Pharmaceuticals, Inc. (800) 987-8256 info@peregrineinc.com
Stephanie Diaz (Investors) Vida Strategic Partners 415-675-7401 sdiaz@vidasp.com
Tim Brons (Media) Vida Strategic Partners 415-675-7402 tbrons@vidasp.com
= = = = = = = = http://www.ncbi.nlm.nih.gov/pubmed/24735771
J Immunol Methods, May 2014 Epub 4-13-14.
“A Novel 'Salting-Out' Procedure For The Isolation Of Tumor-Derived Exosomes”
Brownlee Z, Lynn KD, Thorpe PE, Schroit AJ [PhD, PPHM SAB http://tinyurl.com/hnvps2l ]
Simmons Comprehensive CC, Dept of Immunology, UTSW-MC/Dallas
ABSTRACT:
The last decade has seen an exponential growth in the number of exosome-related publications. Although many of these studies have used exosomes from biological fluids (blood, and ascites or pleural effusions) the vast majority employed vesicles isolated from large volumes of tissue culture supernatants. While several techniques are available for their isolation, all require a significant reduction in volume to obtain sufficient concentrations for study. One approach is to concentrate the medium before proceeding with their isolation, however, these procedures are very time consuming and require specialized laboratory equipment. Here we provide a new and effective method for the isolation of tumor-derived exosomes based on "charge neutralization" with acetate. We show that titration of tissue culture supernatants with 0.1M acetate to pH4.75 results in immediate precipitation of virtually all the exosomes. The precipitated exosomes can be washed to remove residual media and are readily "resolubilized" upon resuspension in acetate-free buffer at neutral pH. This simple cost effective method significantly increases the yield of exosomes from an unlimited quantity of culture supernatants. Exosomes isolated by this technique are indistinguishable from exosomes recovered by direct ultracentrifugation.
= = = = =
U.S. Patent App# 20150241431 - Filed 2-27-15, Pub. 8-27-15
”Methods & Compositions For Isolating Exosomes”
USPO: http://tinyurl.com/hlcxb7f
Applicants: BOARD OF REGENTS, THE UNIV. OF TEXAS SYSTEM; PEREGRINE PHARMACEUTICALS, INC.
Inventors: SCHROIT, Alan, J.; THORPE, Philip, E.; Fussey; Shelley P.M.
Abstract: Disclosed are surprising new methods & compositions for isolating extracellular microvesicles such as exosomes, particularly disease-related and phosphatidylserine (PS)-positive extracellular microvesicles as exemplified by tumor- and viral-derived exosomes. The methods of the invention are rapid, efficient, cost-effective and, importantly, are suitable for use with large volumes of biological fluids and produce antigenically intact extracellular microvesicles and exosomes. The methods and compositions are based on the surprising use of acetate buffers to isolate large quantities of extracellular microvesicles, particularly tumor-derived exosomes, from solution, without damaging their morphological or functional properties or antigenicity.
- - - - - -
INTL. PATENT APP# WO/2015/131153, Filed 2-27-15, Pub. 3-9-15
”Methods & Compositions For Isolating Exosomes”
https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2015131153
AVID REVS & GROSS-PROFIT: Q4(qe 4-30-16) Avid Revs doubled prev.record to $18.8mm; FY16=$44.4mm(+66% yr-over-yr.). GROSS PROFIT Q4=$9.1mm; $21.4mm for FY16 (GM=48%). Guidance for FY17(fye 4-30-17)=$50-55mm. Committed B/L a/o 7-14-16=$68mm.
Avid II (Myford) went fully operational 3-2016. (6-2-16/PR: “Myford ramping up for runs for 3 current clients”). Peregrine is in the process of designing a 3rd mfg. facility “focused on clinical manufacturing”; has already secured a 25,000sf location, and “expect this new (3rd Avid) facility to be commissioned by mid-2017; there is already a backlog of existing business earmarked for the new facility.” ...All this leads to Peregrine expecting, "future sustainable profitability for the company in 24 months".
= = = = = = = = = = = = = = = = = = = = = = = = = = = =
Updated PPHM REVS-BY-QTR TABLE, now thru FY16'Q4(fye 4-30-16), per the 4-30-16 10-K ( http://tinyurl.com/zgognwz ) issued 7-14-16.
• Total Revs since May’06: ($173.6mm/Avid + $24.1mm/Govt + $2.5mm/Lic.) = $200.2mm
• 7-14-16: FY'17 (May'16-Apr'17) Avid revs guidance $50-55mm (Committed B/L=$68mm).
• Deferred-Revs at 4-30-16 total $10.0mm, DOWN from $15.4mm at 1-31-16.
• Cust.Deposits at 4-30-16 total $24.2mm, UP from $22.4mm at 1-31-16.
• Inventories at 4-30-16 total $16.2mm, UP from $15.2mm at 1-31-16.
• Avid’s Gross-Profit over last 4 qtrs: $21.4mm on revs of $44.4mm (GP%=48%)
• Recall, Avid Rev$ 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$ GP%
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%
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%
FY15Q1 7-31-14 5,496,000 3,583,000 1,913,000 35%
FY15Q2 10-31-14 6,263,000 4,139,000 2,124,000 34%
FY15Q3 1-31-15 5,677,000 3,113,000 2,564,000 45%
FY15Q4 4-30-15 9,308,000 4,758,000 4,550,000 49%
FY16Q1 7-31-15 9,379,000 4,608,000 4,771,000 51%
FY16Q2 10-31-15 9,523,000 4,741,000 4,782,000 50%
FY16Q3 1-31-16 6,672,000 3,896,000 2,776,000 42%
FY16Q4 4-30-16 18,783,000 9,721,000 9,062,000 48%
FY13 TOTAL: 21,333,000 12,595,000 8,738,000 41%*
FY14 TOTAL: 22,294,000 13,110,000 9,184,000 41%*
FY15 TOTAL: 26,744,000 15,393,000 11,151,000 42%*
FY16 TOTAL: 44,357,000 22,966,000 21,391,000 48%*
*Avid Net-Profit (ie, incl. Selling, G&A) not split out from PPHM-Corp. in the financials.
.
PPHM REVENUES (in thousands) DEFERRED
-------REVENUES------- REVENUES INVEN-
Quarter Avid Govt Lic. TOTAL Avid Govt TORIES
FY07Q1 7-31-06 398 0 23 421 317 0 971
FY07Q2 10-31-06 636 0 48 684 1388 0 1899
FY07Q3 1-31-07 347 0 16 363 2202 0 1325
FY07Q4 4-30-07 2111 0 129 2240 1060 0 1916
FY08Q1 7-31-07 1621 0 4 1625 1820 0 2363
FY08Q2 10-31-07 1863 0 29 1892 1338 0 3500
FY08Q3 1-31-08 1662 0 13 1675 1434 0 2394
FY08Q4 4-30-08 751 0 150 901 2196 0 2900
FY09Q1 7-31-08 1193 324 0 1517 4021 980 4628
FY09Q2 10-31-08 983 958 0 1941 6472 1701 6700
FY09Q3 1-31-09 5778 1048 0 6826 4805 3262 5547
FY09Q4 4-30-09 5009 2683 175 7867 3776 3871 4707
FY10Q1 7-31-09 2070 4671 9 6750 5755 2332 6177
FY10Q2 10-31-09 5308 1510 78 6896 4260 3989 5850
FY10Q3 1-31-10 2945 6854 78 9877 3052 76 3861
FY10Q4 4-30-10 2881 1461 78 4420 2406 78 3123
FY11Q1 7-31-10 983 2111 115 3209 3719 47 4692
FY11Q2 10-31-10 3627 966 78 4671 2447 35 3555
FY11Q3 1-31-11 1922 882 79 2883 4300 40 3915
FY11Q4 4-30-11 1970 681 78 2729 5617 0 5284
FY12Q1 7-31-11 5439 0 216 5655 4145 0 4481
FY12Q2 10-31-11 4154 0 78 4232 2012 0 3178
FY12Q3 1-31-12 3203 0 78 3281 2552 0 2722
FY12Q4 4-30-12 1987 0 78 2065 3651 0 3611
FY13Q1 7-31-12 4135 0 116 4251 6056 0 5744
FY13Q2 10-31-12 6061 0 78 6139 6221 0 5426
FY13Q3 1-31-13 6961 0 78 7039 5061 0 4635
FY13Q4 4-30-13 4176 0 78 4254 4171 0 4339
FY14Q1 7-31-13 4581 0 107 4688 4164 0 5679
FY14Q2 10-31-13 7354 0 0 7354 3468 0 4033
FY14Q3 1-31-14 3885 0 0 3885 4329 0 5224
FY14Q4 4-30-14 6474 0 0 6474 5241 0 5530
FY15Q1 7-31-14 5496 0 0 5496 4670 0 5998
FY15Q2 10-31-14 6263 0 37 6300 3612 0 5379
FY15Q3 1-31-15 5677 0 0 5677 5752 0 6148
FY15Q4 4-30-15 9308 0 0 9308 6630 0 6148
FY16Q1 7-31-15 9379 0 292 9671 8291 0 10457
FY16Q2 10-31-15 9523 0 0 9523 9688 0 12554
FY16Q3 1-31-16 6672 0 37 6709 15418 0 15189
FY16Q4 4-30-16 18783 0 0 18783 15418 0 15189
Totals: 173569 24149 2453 200171 <=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
FY15 4-30-15 26,781 …Avid(CMO)= 26,744
FY16 4-30-16 44,686 …Avid(CMO)= 44,357
...Total Gov’t Revs from 7-2008 inception thru FY11Q1(Apr’11): $24.15mm
The Patent apps for UTSW/Schroit/Thorpe's “Isolating Exosomes” methods now licensed by Peregrine…
U.S. PATENT APP: ”Methods & Compositions For Isolating Exosomes”
App# 20150241431 - Filed 2-27-15, Pub. 8-27-15 USPO: http://tinyurl.com/hlcxb7f
Applicants: BOARD OF REGENTS, THE UNIV. OF TEXAS SYSTEM; PEREGRINE PHARMACEUTICALS, INC.
Inventors: SCHROIT, Alan, J.[PPHM SAB]; THORPE, Philip, E.; Fussey; Shelley P.M.
Abstract: Disclosed are surprising new methods & compositions for isolating extracellular microvesicles such as exosomes, particularly disease-related and phosphatidylserine (PS)-positive extracellular microvesicles as exemplified by tumor- and viral-derived exosomes. The methods of the invention are rapid, efficient, cost-effective and, importantly, are suitable for use with large volumes of biological fluids and produce antigenically intact extracellular microvesicles and exosomes. The methods and compositions are based on the surprising use of acetate buffers to isolate large quantities of extracellular microvesicles, particularly tumor-derived exosomes, from solution, without damaging their morphological or functional properties or antigenicity.
- - - - - -INTL. PATENT APP# WO/2015/131153, Filed 2-27-15, Pub. 3-9-15
https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2015131153
= = = = = = = = http://www.ncbi.nlm.nih.gov/pubmed/24735771
J Immunol Methods, May 2014 Epub 4-13-14.
“A Novel 'Salting-Out' Procedure For The Isolation Of Tumor-Derived Exosomes”
Brownlee Z, Lynn KD, Thorpe PE, Schroit AJ [PhD, PPHM SAB http://tinyurl.com/hnvps2l ]
Simmons Comprehensive CC, Dept of Immunology, UTSW-MC/Dallas
ABSTRACT:
The last decade has seen an exponential growth in the number of exosome-related publications. Although many of these studies have used exosomes from biological fluids (blood, and ascites or pleural effusions) the vast majority employed vesicles isolated from large volumes of tissue culture supernatants. While several techniques are available for their isolation, all require a significant reduction in volume to obtain sufficient concentrations for study. One approach is to concentrate the medium before proceeding with their isolation, however, these procedures are very time consuming and require specialized laboratory equipment. Here we provide a new and effective method for the isolation of tumor-derived exosomes based on "charge neutralization" with acetate. We show that titration of tissue culture supernatants with 0.1M acetate to pH4.75 results in immediate precipitation of virtually all the exosomes. The precipitated exosomes can be washed to remove residual media and are readily "resolubilized" upon resuspension in acetate-free buffer at neutral pH. This simple cost effective method significantly increases the yield of exosomes from an unlimited quantity of culture supernatants. Exosomes isolated by this technique are indistinguishable from exosomes recovered by direct ultracentrifugation.
= = = = = =
7-14-16: Peregrine Licenses Novel Exosome-Based Cancer Detection and Monitoring Technology from UT Southwestern Medical Center
--New Technology Efficiently Builds on the Company's Existing Phosphatidylserine (PS) Targeting Platform and Assay Development Capabilities
--Stand Alone Program That Offers Significant Value Creation Potential and Early Partnering Opportunities
--New Technology to Also be Evaluated in Conjunction with Ongoing Bavituximab Clinical Development Program
http://tinyurl.com/gmzyg37
Q4(qe/4-30-16) Avid revs to ~double prev.record to $18.4mm
6-2-16/PR: Corp.Update – Avid Expansion & Drug Development - Avid revs for FY16(fye 4-30-16) will be $44mm; since $25.6mm for 1st 3 qtrs, Q4 revs will be ~$18.4mm. Avid B/L currently $56M; guidance for FY17(fye 4-30-17) is $50-55mm. Avid II (Myford) is currently ramping up for runs for “3 current clients”. Peregrine is “in the process of designing a 3rd mfg. Facility focused on clinical manufacturing”; has already secured a 25,000sf location, and “expects the new clinical suite to be complete & ready for clinical mfg. by 1H/2017.” ...All this leads to Peregrine expecting, "future sustainable profitability for the company in 24 months". http://tinyurl.com/zvmhqmr
- - - - - -
AVID PROFORMA – Based on 6-2-16 PR (FY'16/fye=4-30-16 "Revs for FY16 will be $44mm")...
Updated PPHM REVS-BY-QTR TABLE, now thru FY16'Q4(fye 4-30-16), per the 6-2-16 Corp. update PR ( http://tinyurl.com/zntvudj ):
• Total Revs since May’06: ($173.2mm/Avid + $24.1mm/Govt + $2.5mm/Lic.) = $199.8mm
• 6-2-16: FY'17 (May'16-Apr'17) Avid revs guidance raised to $50-55mm.
• Avid’s Gross-Profit over last 4 qtrs: $21.2mm on revs of $44.0mm (GP%=48%)
• Recall, Avid Rev$ 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$ GP%
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%
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%
FY15Q1 7-31-14 5,496,000 3,583,000 1,913,000 35%
FY15Q2 10-31-14 6,263,000 4,139,000 2,124,000 34%
FY15Q3 1-31-15 5,677,000 3,113,000 2,564,000 45%
FY15Q4 4-30-15 9,308,000 4,758,000 4,550,000 49%
FY16Q1 7-31-15 9,379,000 4,608,000 4,771,000 51%
FY16Q2 10-31-15 9,523,000 4,741,000 4,782,000 50%
FY16Q3 1-31-16 6,672,000 3,896,000 2,776,000 42%
FY16Q4 4-30-16~18,400,000 ~9,600,000 ~8,800,000 ~48% <=Per 6-2-16 PR
FY13 TOTAL: 21,333,000 12,595,000 8,738,000 41%*
FY14 TOTAL: 22,294,000 13,110,000 9,184,000 41%*
FY15 TOTAL: 26,744,000 15,393,000 11,151,000 42%*
FY16 TOTAL: ~44,000,000 ~22,800,000 ~21,200,000 ~48%*