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unpathedhaunt

09/09/16 4:52 PM

#272177 RE: cjgaddy #272174

Thank you, CJ, for this transcript and for all the excellent and painstaking work you do.

cjgaddy

09/09/16 5:10 PM

#272180 RE: cjgaddy #272174

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

JamesGMS

09/10/16 2:44 AM

#272212 RE: cjgaddy #272174

CJ, thank you very much for your efforts with the Transcript.

All of your corrections to the SA version are much appreciated.

James

biopharm

09/10/16 7:08 AM

#272217 RE: cjgaddy #272174

CJ, I am very impressed after reading your post with corrections from the latest conference call! I would recommend that anyone holding shares in Peregrine Pharmaceuticals to read it and anyone interested in Immunotherapy / Peregrine to certainly do your due diligence and review it thoroughly.

There are too many things to point out but I will start with the impression that some may have gotten with the stopping of Sunrise thinking it was a negative event ....we know clearly see why, in that biomarker analysis was built into Sunrise Phase III and CEO Steve King said the Bavi arm "Performed as expected" and now, more importantly we see that the information extracted from this study has been granted "late breaking" status for an oral presentation regarding the Sunrise study.

From becoming a profitable biotech company, with Peregrine owning their own successful manufacturing company (which was the driver behind preceded share offerings selling at future prices and....here is the part I really like ==> the part where some may have thought Peregrine was selling the ATM and

All must read the transcript to realize there was no selling related to the ATM which means some big buyers KNOW the scale of biotech and IO and KNOW Peregrine is about to tilt that scale.

Much more but I suggest read the transcript 2-3 times and come to realize the events that are happening Soon...

A big thanks CJ!

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=125071406

cjgaddy

09/10/16 1:14 PM

#272242 RE: cjgaddy #272174

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.

= = = = = = = = = = = = = = = = = = = =
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.”

= = = = = = = = = = = = = = = = = = = = = = = = = = = =
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

cjgaddy

09/11/16 5:25 PM

#272296 RE: cjgaddy #272174

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

cjgaddy

09/13/16 9:44 AM

#272410 RE: cjgaddy #272174

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.

cjgaddy

09/13/16 7:09 PM

#272467 RE: cjgaddy #272174

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

cjgaddy

09/20/16 1:26 PM

#272868 RE: cjgaddy #272174

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”

cjgaddy

09/21/16 1:10 PM

#273003 RE: cjgaddy #272174

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”

cjgaddy

09/23/16 8:11 AM

#273199 RE: cjgaddy #272174

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
--------
###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”

cjgaddy

09/23/16 8:39 AM

#273202 RE: cjgaddy #272174

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
-----
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)
-----
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

cjgaddy

09/25/16 7:07 PM

#273340 RE: cjgaddy #272174

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
--------
###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
= = = = = = = = = = = = =
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 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

= = = = = = = =
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/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”

cjgaddy

10/04/16 9:05 AM

#274383 RE: cjgaddy #272174

Avid exhibiting @IBC/Boston/Oct4-7, Pete Gagnon(VP) speaks tomorrow…

Oct4-7 2016: “IBC's BioProcess Intl. Conference & Exhibition”, Boston
”The largest bioprocessing event bringing you new ideas, demystifying technology and fostering partnerships in highly engaging formats to move drug candidates closer to approval.”
http://www.ibclifesciences.com/BPI/overview.xml
10-5-16/8-8:30am Stream: Recovery & Purification
“Across the Great Divide: The Upstream Origins & Downstream Ramifications of a Newly Discovered Contaminant Class”, Peter Gagnon, VP-Process-Svcs/Peregrine Pharmaceuticals
https://lifesciences.knect365.com/bioprocessinternational/agenda/2
*AVID: Visit us at Booth #716

= = = = = = = = = = =
5-23-16: Pete Gagnon (100pubs/presentations, 12+patents, 30 pending patents) Appointed VP/Process-Services of Avid http://tinyurl.com/hg6abdq – See Oct'15:

...Avid Bioservices, Inc., a wholly owned subsidiary of Peregrine Pharmaceuticals, Inc. today announced the appointment of Pete Gagnon as the company's VP/Process Services. As one of the biopharmaceutical mfg. industry's leading experts and innovators in the purification of biologics, including recombinant proteins, viruses and DNA plasmids, he brings more than 30 years of experience to his new role with Avid. In his new position, Mr. Gagnon's responsibilities will include developing and optimizing innovative technologies for cell culture, purification and analysis, designed to support Avid's expanding mfg. operations.

Prior to joining Avid, Mr. Gagnon spent 25 years as the founder and CEO of Validated Biosystems, an intl. consultancy specializing in hands-on development of biological manufacturing processes. During his time with Validated Biosystems, he worked collaboratively with biotechnology companies around the world to develop and optimize state-of-the-art manufacturing systems built on the latest technologies and capabilities. His work has focused on continuously innovating processes for purifying biologics and has led to the publication of his highly-regarded book, "Purification Tools for Monoclonal Antibodies." Mr. Gagnon is additionally credited with more than 100 scientific journal articles and presentations at major scientific conferences, as well as more than a dozen patents, with an addl. 30 pending patent applications, all describing major advances in purification of biologics. Based on his thought leadership in the industry, he also serves as a member of the editorial boards for BioProcess Intl. and Genetic Engineering News and has appeared as a frequent guest editor and reviewer for several top industry journals. Mr. Gagnon just completed a 5-year residence in Asia, during which he worked with the Singaporean Agency for Science and Technology to help establish bioprocessing as a major center of excellence within Singapore.

"We are excited to add Pete to the talented team of manufacturing professionals who are driving the impressive and consistent revenue growth that we are experiencing at Avid. He brings unique expertise in high-value mfg. disciplines that fit nicely with our recently opened state-of-the-art commercial biomfg. suite," said Steven W. King, CEO of Peregrine and Avid Bioservices. "Specifically, Pete's position as one of the industry's thought leaders in the area of cell line process sciences, which is critical for ongoing innovations in the manufacture of biosimilar products, provide opportunities for the continued growth of our biosimilars mfg. business. This is one particular area on which we'll be focused with the increased mfg. capacity made possible by our new facility and we look forward to the contributions that Pete will make."

Mr. Gagnon, who has served as a consultant to Avid since 2004, commented, "I am grateful for the opportunity to join Avid Bioservices on a full time basis. This is an exciting time, marked by revenue growth, facility expansion and an impressive demand for the company's services. Avid is uniquely positioned in the biopharmaceutical contract development and mfg. sector based on its combination of state-of-the-art manufacturing facilities, equipment, and capabilities. That combination of infrastructure and environment gives Avid an outstanding foundation to drive innovation and provide best-in-class services to our current and future clients."...
- - - - - - - - - -
9-8-16: PPHM's Revs & Burns By Qtr Table, FY'07/Q1 thru FY'17/Q1 (q/e 7-31-16): http://tinyurl.com/jydtkoy (since 5-2006: Avid=$179.2mm, Total=$205.8mm, incl.Govt) - - - Avid FY17 (fye 4-30-17) revs guidance: $50-55mm; committed 9-8-16 backlog: $71mm. Avid III being designed/already secured 25,000sf loc/expect compl=1H/2017. “Expect future sustainable profitability for the co. in 21mos.”

6-2-16: Corp.Update – Avid Expansion & Drug Development - http://tinyurl.com/zvmhqmr

cjgaddy

10/10/16 8:58 AM

#275207 RE: cjgaddy #272174

10-10-16/PR: ESMO’16 Topline/SUNRISE; B2GPI Biomarker(30%pts) StatSig OS 7.7=>13.2mos.

10-10-16: Peregrine Pharmaceuticals Reports Top-Line and Initial Biomarker Data from Phase III SUNRISE Trial of Bavituximab in Oral Presentation at European Society for Medical Oncology (ESMO) 2016 Congress
-- Company Has Identified Beta-2 Glycoprotein-1 (B2GP1) as a Biomarker that Correlates with Statistically Significant Improvement in Overall Survival for Patients Receiving the Bavituximab Combination Compared to Chemotherapy Alone
-- Ongoing SUNRISE Trial Biomarker Analysis Expected to Identify Additional Biomarkers Associated with Patients Benefiting from Bavituximab Treatment that Will Help Guide Program's Future Clinical Development
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=992804

TUSTIN, Oct. 10, 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 reported 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) were presented in an oral presentation at the European Society for Medical Oncology (ESMO) 2016 Congress. The presentation included interim efficacy and safety outcomes, as well as initial findings from the company's ongoing biomarker analysis of samples collected during the study. The SUNRISE Phase III trial was discontinued earlier this year based on a pre-specified interim analysis although patient treatment and follow-up in the study were allowed to continue. The pre-planned biomarker analysis has been taking place as patient follow-up has continued and available results were evaluated as part of the recent top-line data analysis.

The study protocol pre-specified the collection of thousands of patient samples for exploratory analyses over a wide range of possible biomarkers, including pre-treatment levels of beta-2 glycoprotein-1 (B2GP1). Data presented at ESMO demonstrated that patients with pre-treatment B2GP1 levels between 200 and 240 (representing approximately 30% of randomized patients) achieved a statistically significant, 5.5-month improvement (13.2 months vs. 7.7 months) in median overall survival (OS) as compared to patients in the control group with the same range of B2GP1 levels [p = 0.049; hazard ratio (HR) = 0.67]. A similar trend was observed with pre-treatment B2GP1 levels ≥ 200 µg/mL (representing approximately 50% of randomized patients) with 11.9 months vs. 10.1 months median OS in favor of the bavituximab-containing group (p = 0.155; HR = 0.81). Taken together, this strongly suggests B2GP1 levels may be useful for identifying patients who are more likely to benefit from a bavituximab containing therapeutic regimen. Numerous additional biomarkers are currently being analyzed with the goal of developing a multi-marker signature that can potentially identify patients that are likely to receive significant clinical benefit from a bavituximab-containing therapeutic regimen.

Top-line results reported at ESMO today were based on a data cut-off after 70% (330/473) of the targeted OS events had been reached and demonstrated the addition of bavituximab to docetaxel did not result in improvement of the study's primary endpoint of OS in the intent-to-treat population. Median OS for the bavituximab plus docetaxel group was 10.7 months as compared to 10.8 months for the placebo plus docetaxel control group (HR = 1.110; p = 0.382). Median progression free survival (PFS) for the bavituximab-containing group was 4.1 months compared to 3.9 months for the control group (HR = 0.97; p = 0.803). Objective response rates based on independent central review are currently 13% and 11% (p = 0.53) for the bavituximab-containing and control groups, respectively. Additionally, the safety profile of the combination of bavituximab with docetaxel was similar to placebo plus docetaxel.

"With every clinical trial we conduct, we are constantly reminded of the difficulty involved in treating patients with NSCLC. This continues to prove to be a very challenging cancer to combat and the need for effective treatments remains high," David R. Spigel, MD, CSO and Program Director of Lung Cancer Research at the Sarah Cannon Research Institute and one of the lead investigators in the SUNRISE trial. "The findings with regard to B2GP1 that have been collected as part of the ongoing SUNRISE trial data analysis are interesting and support further investigation."

Peregrine intends to further evaluate the role of B2GP1 levels in response to bavituximab therapy in future clinical trials. The company has filed a new patent application directed to the use of this initial biomarker discovery. Additional patient sample testing and analysis is ongoing and may result in other biomarkers of importance.

"We would once again like to thank all of the patients, clinical investigators and scientists who participated in the SUNRISE trial and have made it possible for us to continue to collect and analyze a range of key data from the study. While we were disappointed with the trial being discontinued earlier in the year, we are excited by the fact that we are beginning to learn important information from the trial through the ongoing biomarker analysis program that will be critical in helping guide the future clinical development of bavituximab," said Joseph Shan, VP of Clinical & Regulatory Affairs at Peregrine. "It is encouraging that the initial biomarker analysis has identified an important biomarker early in the process and we are optimistic that additional biomarkers associated with improved outcomes for bavituximab-containing treatments will be identified as the analysis continues. We expect to be able to share the emerging data over the coming months at scientific and medical conferences as the more results become available."

Mr. Shan continued, "It is not uncommon in the cancer field for therapeutic candidates to suffer clinical trial setbacks as researchers continue to learn more about the most appropriate patient populations for those drugs. In this landscape, biomarkers play an increasingly important role in helping identify specific patient characteristics that may impact responses to a treatment. This has been seen historically with targeted cancer treatments, as well as more recently with checkpoint inhibitors including PD-1 inhibitors. We look forward to identifying the equivalent markers for bavituximab that will help guide its clinical development."

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.
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:
Stephanie Diaz (Investors), Vida Strategic Partners, 415-675-7401, sdiaz@vidasp.com
Tim Brons (Media), Vida Strategic Partners, 415-675-7402, tbrons@vidasp.com

= = = = = = = = = = = = = = = =
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 (3:15-3:30amET) #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
--------
###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
= = = = = = = = = = = = =
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
=>10-10-16: ESMO’16 Topline/SUNRISE Data; B2GPI Biomarker(30%pts) StatSig OS 7.7=>13.2mos. http://tinyurl.com/hp73njt
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*

= = = = = = = = = =
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

cjgaddy

10/16/16 11:07 AM

#276376 RE: cjgaddy #272174

Cash Burn Rate for Q1(q/e 7-31-16) rep. 9-8-16: $9,607,000

OPER. CASH BURNS* BY QTR (FROM THE 10-Q/K’S):
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 7-31-16 10Q pg.22 http://tinyurl.com/jmy77g3 )

9-8-16/PR: “Avid's current mfg. revenue backlog is $71 million… The company remains on track to generate revenue in excess of $20mm in Q2FY17 (q/e 10-31-16 rep. ~12-8-16)” http://tinyurl.com/jydtkoy (Cash 7-31-16=$44.2mm)

• Avid’s Gross-Profit over last 4 qtrs(thru 7-31-16): $19.2mm on revs of $40.6mm (GP%=47%)
- - - - - - - - - - - - - - - - -
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

*The 10-Q’s define OPER.BURN as, ”Net cash used in operating activities before chgs. in operating assets & liabilities”.
The 7-21-2001 10Q explains OP.BURN:
“RESULTS OF OPERATIONS. Before we discuss the Company's total expenses (cash & non-cash expenses), we would like to discuss the Company's operational burn rate (cash expenses used in operations, net of interest and other income) for q/e July 31, 2001 compared to the same period in the prior year. The operational burn rate is calculated by taking the net income (loss) from operations and subtracting all non-cash items, such as the recognition of deferred license revenue, depreciation and amortization and stock-based compensation expense.”

cjgaddy

10/26/16 7:51 AM

#277238 RE: cjgaddy #272174

Shareholder Attendee Reports (10-13-16 ASM) – as more come in, I will delete, update, and re-post. THANKS to all attendees for sharing. This update adds FU’s by Eb0783.
WEBCAST Replay: http://edge.media-server.com/m/p/afyt8u2w (45 Slides)

By: Eb0783 10-13-16 #275973
ASM attendees - roughly 40. 20 of us being shareholders.
FU/275979(re: Garnick?): He was a very valuable asset in the meeting.
FU/276020: From the ASM: King said (in answer to a question about B2GP1 stability, a la GJH) that B2GP1 is “relatively stable” among the patients and, although not as much is known about it compared to other proteins, there probably is no more than a +/-10% variation in a given patient.
Dr Garnick said that B2GP1 is only one (and maybe not the most important) of a number of biomarkers and they will have a number of them creating a profile. Lytle said the $$ spend on Sunrise will be finished by around end of calendar year. My take on these two statements is that they will have the analysis done and the biomarker profile will be complete. imo
Garnick shared a story about an early biomarker at Genentech with us that very few people know. Herceptin failed its first trials but one scientist identified the HER2 mutation and saw how many with HER2 lived longer. So they ran another trial which also failed. Garnick and his peers didn't believe in it but one other guy, identified a biomarker that corrolated with the ones who lived, and talked them into spending another $60mm on one more trial. Since then Herceptin has save 1000's of lives and earned $Billions of dollars. He believes in the value of biomarkers and he has been driving it for us.
As to my question of filing the BLA with what we have, [sorry CP, I did agree with your view) Dr Garnick point blank said our data is “not fileable.” We have now proof of concept and need now another trial, even a small phase II, to validate. Keep in mind however that means a smaller trial and with biomarkers involved it could be shorter than we imagine. imo
On a sidebar with just Shelley and I, Shelly Fussey said they have filed a detailed provisional patent on the Biomarkers which sets the filed date, keep it from being published/shared, and allows inexpensive additions/updates for a number of months (forget if it was 6, 9, or 12). Basically, we the public, and their competitors, will not be able to access it for 18mos. It also adds another year to the patent protection that way.
Edit: Avid III has not actually begun construction as the lease is still being negotiated. However the design, equipment models, etc is ready to begin. Some others will probably add some color because they gave 11 of us a tour of the Myford facility. I call that "shareholder friendly."
FU/276047(To HD): King told us before that ps targeting will be an astronomical value and your verbose presence here continues to confirm that for me. Thank you again for your support.
FU/276054(re: Expenses?): You are right. In fact Lytle said they have already reduced expenses by 38% and will be completely finished with Sunrise expense by end of year. Don't believe those who try to say they have not reduced.
FU/276076(Future?): LOL Loofman, You are still here for the same reason the rest of us "believers" are: The potential rewards are Astronomical (even hornet knows it as he is trying to talk us out of our PEARL every day) but it is only taking a little longer.
FU/276334: I wanted to add one more item from the Avid tour. In past Q&A during one of the latest CCs, King talked about how profitable “fill & finish” is and how he wanted to get into that part in the future. Well, part of John Haney’s presentation was a discussion on what “Fill & Finish” is and why we would want to do it (profitable due to difficulties in keeping the product pure). From his explanation, description, and excitement, my take-away is that he has the design, equipment layout, and process already to fit into the next space.
FU/276490(to ExW re: Herceptin data mining analogy): Missing the ASM made you miss this. Herceptin was NOT originally developed for HER2: data mining pointed them there. Garnick said they did a phase III after screening for HER2 and it also failed! Then one more round of "data mining" gave one scientist enough leverage to convince them to do one more. At that time they had nothing else in the pipeline. Sound familiar? With that addl. biomarker screening they ran a successful phase III and the rest is history. That is how I remember it. Some here seem to denigrate and demonize "data mining" but I see the benefit.
FU/276505(to ExW re: Herceptin analogy): I’m just telling you what I think I heard from Dr. Garnick who said, “very few people know this.” That implies to me that it is not included in any public documents. On top of that, one of the most discussed “problems” still today [there is even talk of legislation to correct it] in getting FDA approvals is that BPs often do not include “all” the information (like trial failures) in the BLAs that they file. I’m not making something up, just bringing into question rational reasons why this FDA document may not tell us about failed trials. Why would it? I may be incorrect that it was a phase III as it could have been a phase II but he said they spent $30?mm on the failed trial and this one guy convinced them (even though their committee didn't believe in it) to spend another $60mm on another trial, Phase III. ASM attendees please correct me.
FU/276539(re: Planning future trials): Yes, this is exactly what King said. The biomarker (profile) will let them filter out those who do not benefit and that will be entrance criteria for the next trial which only needs to be about 30% of the Sunrise 600 and that 30% will provide stat.sig. performance (74%?) on OS or other chosen end points. Addl. biomarkers found that can add to the profile will make it even more precise and possibly less than 200 pts could be used.
FU/276543: Brandon Cox was talking to Jeff Hutchins & Steve Worsley before the meeting started and much of that was about the aPS + aPD1 + aLAG3 data. I don’t think MSK was mentioned in that discussion (I was listening to some of it). I know he was asking about next steps for that data. I will let Brandon share that with you, if he will.
FU/277081: Jake, At the ASM Q&A King was asked is we were talking with Merck and he succinctly answered, "Yes."
FU/277180(Avid Expansion): Jake, I wish you had been there for the Avid tour so you could hear & see what is happening there. You would have gotten a great deal from it. I spent a number years doing project eng. & mgt. work myself, so I think I can see where some items can be checked off. Peregrine has been a neighbor to the tenants & landlords around them for a few decades. They are well enough known to them, have relationships with them, and have expanded a number of times in that locale over the years. I don’t think the landlords around them have any issues about their credit worthiness. They have surveyed the available sites, have leased some already for various purposes, and they know the advantages/disadvantages of each of them for the purposes they will use them for. The design for the new facility is a smaller but cookie cutter version on Avid II. John Haney also mentioned that the parking used by PPHM at Myford is considerably less than an office tenant would need and he spoke as if that was a plus for them at that location. The only hold-up (time-wise) I see right now is whether they can get the lease signed in the most desirable site or if they will relent and use one that may take a little more infrastructure build-out. It is their timeline and they will decide how much negotiation time is too much (it could be done as we type this). I might also add, imo, that if the demand for a product/service is great enough, there are a myriad of ways to get it financed, including various levels of customer input/$$. I experienced that in another industry.

By: Robert C Jonson 10-13-15 #276028
Eb, I thought I heard Rob Garrick say our trial didn’t give proof of concept, just a correlation with the Bavi + 200-240 group, and another proof of concept trial would have to be done. I asked Steve King about betabodies and he said they're still in the picture and should help out with B2GP1 problem. I also asked about earthquake provisions and he said the production labs have been designed to weather earthquakes, but the ultimate provisions are to expand our mfg. facilities to other locales, possibly to include international sites. I asked him lastly about timing to implement the RS and he said as late as possible to give other upcoming events as much time as possible to raise our pps back to the minimum required (or higher). This ASM was as good as one could be after a company has failed a phase III trial, and the NCCN preliminary data on the triple combination of Bavi, PD-L1, and LAG-3 is particularly exciting. It was particularly fun to socialize with PPHM shareholders, most of whom I knew, but some whom I met for the first time. RCJ
FU/276161: Eb, or North, or someone else who attended the ASM yesterday, please correct or expand me, but in response to a question about advancing our finding of the biomarker, Steve said he'd have to be 99% certain of the correlation first. Brandon asked if that meant a p value of .01 instead of .05 and Steve answered "yes." He then said further analysis of Sunrise data might provide addl. biomarker identification that could bring the confidence level up to 99%.
FU/276173: One person who really impressed me yesterday was John Haney, who I call Peregrine's/Avid's logistician. He conducted the first half of our tour of Avid's facilities and told us that Avid was NOT growing: it is EXPLODING! He said a major reason for this is the tremendous increase in efficiency of the manufacturing process. In the past it was only possible to obtain a few mg's of product from a batch of mix. Now, from the same amount of mix, they are obtaining 2-4 grams of product.
FU/276212: Right, JJ, another surprise for me was that we found out Avid has 10+ customers now vs the 1-2 we had heard previously!
FU/276465: Data mining may not be a preferred means of getting results, but it can be good. Rob Garnick told us at the ASM that without data mining there would be no Herceptin today, a drug that's sold $8-10bb.
FU/276485(to IFU): Rob Garnick brought up Herceptin as an analogy to how/why PPHM is analyzing the Sunrise data.

By North40000 10-14-16 #276066
The attendees at the ASM did not care how timely the meeting started---why should you? Attendees, including us, were quite satisfied talking with management and BOD members pre ASM. The meeting started at 10 or shortly thereafter.
FU/276071: Reverting to an earlier exwannabe post prior to start of ASM, ex is correct no BLA will or would be filed today, per Dr. Garnick's opinion expressed post-close of original ASM presentations...it would be "laughed out of Washington" he said. I rejoined that a lot of funny things happen in Washington these days. Dr. Garnick responded with reliance on his Herceptin experience with Genentech[DNA], and the need--in his opinion--for completion of analysis of Sunrise trial to determine existence of further biomarker data or other data that would provide concrete evidence of validity of the proof of concept data now extant today.
More on this issue when I return to East Coast next week, with access to transcripts or audio record, if any, on what was said.
FU/276075: SK: the RS split will not be immediate, answering your speculation about today or tomorrow. Rather, he said, any RS will be delayed as long as possible. Others who attended likely have already commented to same effect.
FU/276077(Worsley?): Worsely was there. I had no discussions with him, and have no idea what others may have discussed with him before or after ASM.
FU/276086(To Eb0783): We enjoyed visiting with you again, as well as the Avid facilities tour.
FU/276088: As further proxies were collected from attendees at ASM, and were yet to be counted, the actual vote count on proposal 1 was not announced during the meeting itself, only the result. Results themselves were obviously apparent from data and votes on hand during the ASM.
FU/276204: I noted that PPHM had obtained a new stock transfer agent some time ago, and asked whether PPHM had monitored who, or what entity, was buying, selling or accumulating shares of PPHM; I further noted that share price had been cabined in a lid of some sort day to day for some time. PL, CFO, responded to my question and comment. As CP has noted previously on other occasions, and consistent with PL's response, the stock transfer agent is not necessarily aware of certain trades itself known by a certain acronym. As to trades known by the agent, PPHM is aware of them as well as any accumulation > 5%. He reminded us of shareholder protection plan in place that enables certain activities by the BOD. I will not detail those here - they can be posted by others as necessary or desirable.
FU/276323(re: AZN?): The analysis of the Sunrise data in regards to biomarkers is critical to the design of all future trials. Peregrine knows it and so does AZN. AZN is not gone. The future of biomarkers is the ability to zero in on target patients to greatly improve the odds of success while helping patients survive. Any person who attended the ASM would have heard that message from King, Garnick, Shan and others. They have valuable data that could lead to a lighted pathway. According to King, that analysis should be completed by yr-end. The Herceptin story was used as an example by Garnick to illustrate a drug developed from data after failing 2 clinical trials. Garnick also commented that the MOA of Herceptin is still unknown, but as science advances we gain the ability to identify and target specific biomarkers that improve patient outcomes.
FU/276472(re: Avid II & III in Calif): Training purposes for later duplicate facilities to built elsewhere: Dr Garnick's words, not mine.
FU/276598: Dr. Garnick spoke with at least some PPHM ASM attendees, including my wife and me, after the meeting was adjourned: 1) Herceptin experience as he[Dr. Garnick] related it...DNA had only prelim. data that targeting Her2 worked or gave good results in some patients... [DNA] needed further addl. data from another, prospective trial---that trial needed to include the pre-identified Her2 patients. Only a very few, including the original project leader and perhaps Garnick himself, thought THAT addl. trial would produce info that would be useful or that Her2 was in fact useful as a target; top mgt did not. But DNA had nothing more in its pipeline at the time. Finally, or ultimately, top mgt of DNA was convinced to invest what Garnick said was $60mm for that addl. trial. 2) As a further side-note, CJ told me directly that, following the ASM, he and the BOD would convene an extended meeting until what he expected to be early evening hours to discuss various matters/issues....what those might be he did not say, nor did I ask.
FU/276514: "BJ", one of our guides on the tour of the Avid facilities on the afternoon of 10/13/2016, was a neuro-scientist himself with PPHM before switching over to Avid, for how long I did not ask. He originally was from the bay area of SanFran. John Haney, who began our tour, is a mechanical engineer with a great deal of experience in property location & acquisition for purposes intended. Like SK, John had a great many slides shown to us that he employs to demonstrate Avid facilities to customers & visitors. I have not looked on Avid web-site to see what slide decks may be there.

By Djohn 10-13-16 #276058
Expanding head count? Of course. Avid is expanding like wildfire. FDA, biosimilars. 12 customers, $20mm in revenue turned down in 2017 because of capacity constraints.
FU/276225: I would say The GM of biotech in 10 years. From what I saw yesterday PPHM has perfected the manufacturing assemble line of biotech. It will be replicated all over the world IMO. Nice meeting all of you at the ASM and Avid tour!!

By JJ1223 10-14-16 #276197
John Haney was well versed and impressive with his presentation on future Avid growth. I was surprised that Peregrine had to turn down $20MM of business in the past year due to capacity. He made it easy to see Avid's vision of growth and why SK see's total corporate profitability within the next 21mos. Also impressed by his comment of 1-2 new customer visits per month, and their enthusiasm to "get" started. No one I spoke with was happy with the Sunrise results, but the Biomarker data could surprise. We will know by year-end. I am not happy with delay, but I walked away with a clear picture and understanding that my long term investment is probably more secure than at any time in the past. For those who believe Steve King was not positive, I would have to disagree.
FU/276237(to HD): Not true at all. Fact is they tried to lease addl. in the Myford building, but the landlord had made improvements and wanted an unreasonable price. The addl. space in that building remains vacant today. Avid leased across the street at a much better price/sf and a more accommodating landlord. BTW, 6 new clients have already booked for the new facility expected to be operational mid 2017. The search for addl. space is underway at present, with a vision of major expansion planned. "Explosion of business", and "perfect storm" in terms of the business environment were the themes we heard during the Avid tour. Avid now employs 220 people (growing 6 just this week) and the facilities are massive and very impressive. If anyone gets the opportunity to hear John Harney speak about Avid, or tour the facility, you should do so. Sounds like Biosimiliars will play a big role in the future growth of the business at Avid. IMO, Pete Gagnon plays a very important role here.
FU/276487(to IFU re: Herceptin data mining analogy) Perhaps you missed Garnick's point since you did not hear it directly from him. He stressed the importance of analyzing the data by saying that Herceptin failed a PI and PII trial dramatically. No one at Genetech wanted to proceed any further. It was dead until one scientist noticed something in the data and convinced others to take a look. The comparison to Herceptin is not the point. In a Biomarker world, it is critical to understanding.

By Hawkfan1 10-15-16 #276290
I also think that John Haney (Avid Sr.Proj.Mgr, prev: Genentech, Pfizer) is a very impressive gentleman, and his enthusiasm is contagious. It's too bad that he couldn't finish the rest of the Avid tour with us. The tour that Paul and I got with him last year was much better than this year's. I haven't seen anyone else post about this, so I thought I'd add a few details about Avid's current state and future plans. Anyone who was at the ASM, please feel free to make additions or correct any errors. Avid has leased 2 buildings since last year. The one that they are calling the Michelle building (it's a half a block northeast on Michelle Drive) is all office space. They have also leased another building on the other side of Franklin Ave. (I think they called it Franklin II, if I'm not mistaken). They leased this one to be the home of Avid III, or a water purification plant when they couldn't work out a deal with landlord of the Myford building. He had decided to improve his building in the hopes of enticing a Google type business at three times the rate that we are paying to lease Avid II. He added all kinds of amenities (including an outdoor seating area with a fire pit!) to attract creative programmer types, but a warehouse district is not the most desirable location for this type of business, and it has been vacant for the past year. John has been negotiating with the owner, and while he stopped short of saying that he is becoming more reasonable, he noted that he has investors too, and John is hopeful that they can come to some kind of suitable arrangement. He would like to lease the other half of the Myford building to build a water purification plant to support Avid. Currently, Avid buys the water that they use in the cell growing process in barrels. I've forgotten how many gallons John said that they use, but each run costs about $150,000.00 just for the water that they buy. If he is successful in negotiating a lease of the Myford building, then the Franklin II building would be used for warehouse space. The Myford building has a limited amount, but not enough. John also talked a little about some pf the challenges of building the water purification plant. Interestingly, in it's finished state, the water is so pure that it can leach the ions out of the stainless steel pipes that carry it, and they must keep the water circulating to prevent this. Before John had to leave, he also made the comment that he is already looking for his next building, which I assume would be the home of Avid IV, since he has already made other plans for the other 2 buildings.

FU/276506(to ExW re: Herceptin data-mining analogy): My purely uneducated guess as to why we didn't data mine the phII is that there were insufficient numbers in that study to achieve statsig. in any subgroups that they might have found, so it wouldn't have meant much. Just a guess… Regarding the Herceptin trial, I have in my ASM notes that the PhI showed safety, but the phII didn't show much, if any, benefit at all. Most of the powers that be at Genentech (including Garnick) were for dropping the drug, but as eb points out, they had nothing else in the pipeline. Then Dr. Cowen re-analyzed the data, and found that a subgroup of patients that over-expressed Her2 had benefited. He developed a test for Her2 expression, and convinced Genentech to run a $60mm PhIII that pre-selected for the over-expression of Her2, and the rest is history. Hope that clarifies some of the confusion.

By Copper888 10-18-16 #276580
Thanks to all attendees of the ASM for your great recaps and it was a great pleasure to meet you and spend some time together! Everyone did a great job of recapping the discussion portion of the meeting, so I don't have much to add except for a few observations and verifications.
1. B2GP1 discussion - I wrote in my notes several times the phrase "layering of biomarker data" and "layering selection criteria" They have the B2GP1 data but are looking for all the data to come in to further "explain the effects" of the stat sig population. New Data is coming in "every day" and should be complete in the next 3 months. They stated that they want to be 99% sure before moving forward with any confirmatory trials, whether that is a registrational PHII or Phase 3 trial.
2. Avid - John Haney indeed described the business as exploding and attributed the growth to what he called the "perfect storm" of market factors aiding growth including:
i) FDA now has a clear path for approval of biosimilars
ii) Production Tech has now improved to the point that, in his words, "little Avid" can produce a worldwide supply of a given drug and compete with the largest producers of biologics.
He also mentioned that the speed to enter into production agreements used to be a year long courtship. Now companies are begging to get on the schedule and using early test runs just to get a relationship with Avid and hopefully try to jump the line.
They expressed their interest in building new facilities - mentioning places like Europe, Singapore, and other parts of the US taking advantage of local tax incentives to build and to decentralize for risk mitigation (earthquakes and such).
Now comes my personal gut feeling about what I heard...let the chastising begin :)
I think there is a shift on how the company execs and BOD view the business. As mentioned by multiple posters, SK said that they are still looking to hit a "homerun" with Bavi. But I think that they are now doing that in a framework of risk avoidance, and profitability as their primary goals. With every initiative mentioned, SK would talk about partnering in the next sentence. Exosome testing with a partner; potential of exploring the utility of Beta Bodies - would "advance aggressively with a partner"; If Sunrise data warrants a small study to confirm, they would "partner the next step", etc. I think that for good or bad...the new company directive is the march toward profitability. He also said that the company is worth multiples of its current market cap and that they want to delay the RS as much as they can. "I am focused on getting the Share price over a dollar" He mentioned that there may be many events between now and April that may get us there. Well, that is it...I tried to furiously write direct quotes as much as I could. For those in attendance, Please feel free to correct or add to anything written here… Hope that this is of some value!

WEBCAST Replay (10-13-16 ASM): http://edge.media-server.com/m/p/afyt8u2w (45 Slides)
Slideshow PDF (45 Slides): http://files.shareholder.com/downloads/PPHM/2879585795x0x911689/C8068896-AF8B-4CAA-A08C-FB483775B2AD/20161013-_PPHM_Corporate_Overview_-_ASM_FINAL.pdf
EXCERPTS:






















----------
BAVI MOA 10-22-16: Duke’s Herbert K. Lyerly (w/PPHM) poster on AntiPS/TNBC data at AACR’s Tumor Immunotherapy Conf./Boston http://tinyurl.com/zzryfok
...”Modulating The Tumor Microenvironment to Enhance Cancer Immunotherapy by Inducing Phosphatidylserine Expression on the Tumor Surface”

Nov9-13 2016: (SITC’16) Society for Immunotherapy of Cancer 31st Annual Meeting, Natl-Harbor MD http://tinyurl.com/j4tw5p9
...”First Results” from our collaboration with Jedd Wolchok Lab investigators (MSK) to be presented” (per 9-8-16/Ccall/Hutchins)
...I. “PS Targeting Antibody in Combo w/Checkpoint Blockade & Tumor Rad. Therapy Promotes Anti-Cancer Activity in Mouse Melanoma” - Sadna Budhu, PhD - Ludwig Collaborative Lab, MSKCC
...II. “Antibody Targeting of PS Enhances the Anti-Tumor Responses of Ibrutinib & anti-Pd-1 Therapy in a Mouse Triple Neg. Breast Tumor Model” - Jian Gong, PhD, PPHM
...III. Monoclonal Antibodies Targeting PS Enhance Combinational Activity of the the Immune Checkpoint Targeting Agents LAG3 & PD-1 in Murine Breast Tumors” - Michael Gray, PhD, PPHM

cjgaddy

11/21/16 12:18 PM

#279204 RE: cjgaddy #272174

Peregrine's Op.Cash.Burn for Q1(7-31-16) was $9.6mm (vs. Net Loss of $12.4mm) - see http://tinyurl.com/jydtkoy . We know from 9-8-16/PR-CC that Q2(10-31-16) Revs (to be rep. ~Dec8) will "be in excess of $20mm". With Avid's GP% running around 48% and depending on how much "in excess" of $20mm revs are, it'll be interesting how close we come to Positive Cash Burn for Q2. We'll find around Dec 8th or so!

cjgaddy

12/13/16 1:24 PM

#281578 RE: cjgaddy #272174

12-12-16 Qtly CC-Transcript, PR(Financials Q2FY17/qe10-31-16), updated Avid Revenues History Table By Quarter…
=> Total Revs May06-Oct16: $202.5mm/Avid + $24.1mm/Govt + $2.4mm/Lic. = $229.2mm.
Cash at 10-31-16: $49.1mm (Op. Cash Burn for q/e 10-31-16 was $2.6mm – see below).
As of Dec. 8, 2016, there were 257,141,534 shares outstanding.

This large post has 3 sections:
I. 12-12-16 Q2/FY17 Qtly. Earnings Conf. Call TRANSCRIPT (q/e 10-31-16)
II. 12-12-16 PPHM Press Release: Q2/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/z9p7pf4 ], with numerous corrections made. )))
Link to webcast replay: http://ir.peregrineinc.com/events.cfm => http://edge.media-server.com/m/p/x8b7exde
FULL TRANSCRIPT…
12-12-2016 FY’17/Q2 Earnings Conf. Call (q/e 10-31-16) (King/Shan/Hutchins/Lytle)
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. I like to begin by just reminding everyone that we operate 2 separate, but linked, businesses under the Peregrine umbrella. These businesses represent our R&D efforts and our contract mfg. business, Avid, respectively. Taken together, our goal is to bring the overall company to profitability within the next 18mos. by controlling costs and growing revenues. Equally important is to make sure that our market cap adequately reflects the value of each of these business units, which currently does not seem to be the case. Given our revenue history, current year revenue projections at $50-55mm, and backlog of future business at over $70mm, we believe just the value of Avid Bioservices is far greater than our current market cap and is only growing in value. The Avid business is on track to continue its revenue growth this FY. Actually, our 2 facilities have the potential to generate in excess of $80mm in revenue, leaving addl. capacity for revenue growth beyond the current FY and into next year. Even with this available capacity, we are moving forward with our plans to construct a 3rd mfg. facility in order to meet the anticipated commercial needs of our clients, while continuing to grow the business by bringing in new projects. As we continue planning the new facility, we're keeping a close eye on efficiencies that will reduce the overall cost of construction, and once built, the cost of operations. While this may delay the new facility launch until later in CY2017, we currently have adequate existing capacity to continue meeting the needs of our current clients while also bringing in new customers. So, we do not expect any delay in construction to impact our near term or long term ability to grow top line revenue as originally planned. Business at Avid is brisk, with several process validation campaigns either underway or completed in our Myford [“Avid II”] facility, continuing commercial & clinical production at our Franklin [Avid I”] facility, and new projects being initiated. Taken together, this gives us great confidence in the future of the business. In addition, another milestone was achieved during the quarter as we successfully completed a pre-approval inspection with Health Canada for a client product that is currently under regulatory review in that country. This adds the Avid’s strong regulatory track record with multiple successful inspections from regulatory agencies in the US, EU, Brazil, and Canada. Our regulatory success, our unique ability to provide a wide range of services from cell line development to commercial mfg., and our reputation for delivering quality products continues to drive demand for Avid’s capacity. We are also continuing to evaluate other growth opportunities for the business. This includes the evaluation of downstream, high margin services, which will allow us to increase our footprint with clients.

On the R&D side of the business, we announced a series of important findings in recent months, all of which will contribute to our future development of bavituximab. Our ongoing analysis of the Phase III SUNRISE data has revealed a promising biomarker that may give us insight into key patient populations. We are currently evaluating addl. biomarkers that we hope will allow us to identify a profile for patients who will receive therapeutic benefits from a bavituximab-containing treatment regimen. Concurrent with our internal clinical work, our collaborators at NCCN are in the process of initiating trials for 3 new bavituximab combination treatments, which we expect to begin enrolling patients in the coming months. What is exciting is that the NCCN studies will help build on developments that we are seeing from our internal scientists, as well as our collaborators at Duke, Rutgers, and Memorial Sloan Kettering Cancer Center. Together, we presented compelling data supporting our long-standing belief that bavituximab significantly impacts the tumor microenvironment, creating a more immune -active environment in which other therapies, including checkpoint inhibitors, are able to have a greater anti-tumor effect. These findings are highly validating and we look forward to continuing our work with these world-class institutions to help guide clinical development. We believe the data from the new clinical studies being initiated, other clinical opportunities in development, and the continuing mechanistic and immune-oncology combination insight provided by our scientists & collaborators can add significant value to our R&D business, including creating partnering opportunities, even with a tight control of expenditures that will allow us to reach our profitability goal. I'll now turn the call over to the other members of our team who will give a detailed overview of our clinical, pre-clinical, and corporate activities, as well as our Avid Bioservices contract mfg. business. We will begin with Joe Shan, VP/Clinical & Regulatory Affairs.

JOE SHAN (VP/Clin.&Reg. Affairs) – CLINICAL TRIALS:
The SUNRISE Phase 3 trial was discontinued earlier this year. Patient treatment and follow-up on the study were allowed to continue, and currently a number of patients are still receiving bavituximab maintenance. As we previously reported, the study protocol pre-specified the collection of thousands of patient samples for exploratory analyzes over a wide range of potential biomarkers. This analysis has been taking place as patient follow up has continued. Through this biomarker analysis, our team has identified a promising correlation between OS and pre-treatment levels of beta-2 glycoprotein-1 (B2GP1), which was presented at ESMO in October [10-10-16: http://tinyurl.com/hp73njt ]. These results were based on a data cut-off after 70% of the targeted overall survival events in SUNRISE had been reached. Interim analysis demonstrated that patients with pretreatment beta-2 levels between 200 and 240 µg/mL, representing approx. 30% of randomized patients, achieved a statistically significant 5.5mos. improvement in MOS from 7.7mos. in the control group to 13.2mos. in the patients receiving bavituximab & docetaxel. A similar trend was observed with pretreatment B2GP1 levels greater than 200 micrograms per mL, representing approx. 50% of randomized patients. We believe that these observations strongly suggest that B2GP1 levels may be useful for identifying patients who are more likely to benefit from a bavituximab containing therapeutic regimen. We plan to further evaluate the role of B2GP1 levels in response to bavituximab therapy in future clinical trials, and the company has filed a patent application directed to the use of this initial biomarker discovery. While we are disappointed SUNRISE did not meet the pre-specified clinical endpoints, the data from SUNRISE will be critical in guiding the future clinical dev. of bavituximab. In a rapidly changing oncology treatment landscape, biomarkers are playing an increasingly important role in helping identify specific patient subgroup characteristics that may predict response to a treatment. This has been seen historically with targeted therapies, as well as more recently with checkpoint inhibitors, including PD-1 inhibitors. Numerous addl. biomarkers are currently being evaluated with the goal of developing a multi-marker signature that can potentially identify patients that are likely to receive clinical benefit from bavituximab. Ideally, these biomarkers can be applied not only to chemotherapy combination approaches, but also to I-O combinations, including the checkpoint inhibitors. As we'll hear from Jeff in a minute, we and our research collaborators are generating very exciting data to support the advancement of clinical dev. of bavituximab with I_O approaches, and we plan to incorporate potential biomarkers identified from SUNRISE into future clinical trials.

Meanwhile, as Steve mentioned, we're pleased by the NCCN’s award of 3 grants to investigators for clinical trials of bavituximab in combination with other therapeutics for the treatment of Glioblastoma, Head & Neck Cancer and Hepatocellular Carcinoma [9-6-16: http://tinyurl.com/gutgwb5 ]. These grants were awarded to researchers at the Moffitt Cancer Center, Mass General Hospital Cancer Center, and The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. These NCCN studies which we expect to be initiated in the coming months align with our dev. strategy for bavituximab, which is currently focused on small early stage clinical trials evaluating the drug in combination with other cancer treatments, including chemotherapy, radiation, and checkpoint inhibitors. 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. That concludes my comments today. I’ll now turn the call over to Jeff Hutchins, VP/Pre-Clinical Research.

JEFF HUTCHINS (VP/PreClinical Res.)
As Joe's team mentioned and the important clinical progress they've made during the qtr, the pre-clinical group has also reported findings that further illuminate bavituximab’s role in treating cancer. In recent months, we have announced results from studies conducted with collaborators at Memorial Sloan Kettering Cancer Center, Duke University, and Rutgers University College of Medicine, as well as our own internally conducted pre-clin. research. The presented results of this work reinforced our belief that bavituximab plays an important role in transforming what we call “cold” tumor microenvironments, which are characterized by immunosuppression and an inability to generate an effective attack on tumors into “hot” tumor microenvironments that exhibit high immune activity and are pronged with specific cells to fight tumors. During the past qtr, we have presented data from several studies showing that meaningful tumor microenvironment shifts occurred when a bavituximab like antibody was administered as part of a combination treatment regime with checkpoint inhibitors such as anti-PD-1, anti-PD-L1, and anti-LAG3, as well as with radiation and/or chemotherapy. This shift in tumor microenvironment from cold to hot as was evidenced by greater increases in the activity of several critical immune activating pathways, including presentation and processing of antigens and signaling and activation of T cells. We believe that these immune activating mechanisms can be an important component of combination treatment approaches to cancer. Currently it is estimated that 40-70% of cancer patients don't respond to available anti-cancer therapies due primarily to the immunosuppression impacting their tumors. Our pre-clinical work suggests that bavituximab can help reverse this immunosuppression creating an immune active environment that can potentially convert these non-responders to responders. Importantly, we think that this priming of the tumor marker environment is not only relevant for enhancing response to immunotherapies, but also for more traditional cancer treatments such as radiation & chemotherapy. While we are excited by the data we've generated, it is important that we also demonstrate the practical impact that this activity can have on tumors. To this end, we have presented promising data from a study in a Triple Negative Breast Cancer model at the 2nd Intl. Cancer Immunotherapy Conference in September [9-27-16/AACR-CRI: http://tinyurl.com/zy9yv78 ]. These findings showed that 80% of animals receiving a pre-clinical bavituximab equivalent combined with anti-PD1 & anti-LAG3 therapies experienced complete tumor regression. This is in contrast to findings that showed no complete regression among the animals in the treatment group that received a combination of anti-PD1 & anti-LAG3 alone, without the equivalent of the bavituximab.

In a follow-up presentation from the same study at the SITC Annual Meeting in November [11-14-16/SITC’16: http://tinyurl.com/js3fca4 ], we reported these complete regressions for long, durable, and suggestive of immune system memory and adaptive immune responses. This is just one example of the type of preclin. work that has generated the excitement at Peregrine about the potential of bavituximab in combination cancer therapy. But we recognize that this work needs independent outside validation from the academic community. To this end, we are thrilled to highlight our ongoing collaboration with scientists at Memorial Sloan Kettering, which is being led by doctors Taha Merghoub & Jedd Wolchok, two of the world's most foremost experts in the field of cancer immunotherapy. Their work in a mouse model of B16 melanoma, also presented at the SITC meeting [11-14-16: http://tinyurl.com/js3fca4 ], showed that PS targeting antibodies synergized with both anti-PD1 & radiation therapy to improve anti-cancer activity for tumor burden & survival. As well, this combination uniquely led to a change in the tumor microenvironment, shifting it from immunosuppressive, in which tumors which are protected, to immune active, in which tumors are more susceptible to immune related treatments. We recognize that these research results while exciting are in preclini. cancer models and must be translated into human studies. This is a key objective of the 3 NCCN clinical trials that Joe just mentioned that are expected to be initiated in the coming months. We look forward to continuing our research activities on bavituximab treatment combinations with our collaborators and present new findings as they are available. That concludes my comments today. I'll turn over the call to Paul Lytle, CFO…

PAUL LYTLE (CFO):
Before I begin, I’d like to reiterate our financial goal of becoming profitable on an overall basis 18mos. from this past qtr-end. Our strategy for achieving this goal is built on growing revenue from our contract mfg. business, Avid Bioservices, while reducing our overall spending on R&D. We have made great strides over the past 2 qtrs in both growing revenue and reducing our R&D spend, thereby reinforcing our commitment to this goal. I’ll first address our contract mfg. revenue. During Q2/FY’17, we achieved all-time high revenue of $23.4mm, and while we expected to have a very strong qtr as some revenue shifted from Q1 to Q2 due to an outside testing delay which was discussed last qtr, I am pleased to say that those delays have been resolved and we have recognized to-date $29mm in revenue over the past 6mos. This represents revenue growth of 53% compared to last FY. Given the performance, we are able to reaffirm our full FY2017 revenue guidance of $50-55mm. We also have a strong revenue backlog of $73mm under signed contracts that supports this revenue growth. This backlog mostly covers services to be completed during the remainder of FY2017 & FY2018. I’ll address the 2nd part of our strategy, which is to reduce our overall spending on R&D. As we announced last June, Peregrine has made a decision to focus our internal drug dev. efforts on small, cost effective, early-stage clinical trials designed to attract potential partners to further advance our products. We believe the strategy will not only help us achieve profitability sooner, but it could also create significant potential upside for our shareholders. As we execute on the strategy, our R&D expenses decreased 51% this qtr compared to the same prior year qtr, and for the current 6mo. period our R&D expenses declined 45% over the same period last year. The result of the strategy has translated into a reduction in our net loss by 69% for the qtr and 44% for the 6mo. period vs. the same prior year periods. And, if you deduct non-cash expenses from our net loss this qtr, we saw our net cash burn rate for the qtr decline 78% to $2.6mm compared to $11.7mm for the same qtr last year. As I mentioned before, we're making great progress towards reaching our goal of profitability. A more detailed analysis of our statement of operations is included in our Form 10-Q that will be filed shortly [ http://tinyurl.com/j2u2bjk ]. This concludes my financial overview. I will now open the call up for questions.

Q&A: [beg. 22:10]
1. Thomas Yip (FBR & Co.): http://www.fbr.com
TY: ”Can you just remind us what was the magnitude of Avid’s delayed revenue recognition between Q1 & Q2?”
Paul Lytle: The overall delay is that last qtr we mentioned that we had an outside testing lab that is responsible for performing certain tests, and that testing lab was backlogged with certain activities and therefore we couldn’t recognize a certain amount of revenue last quarter that was shifted from Q1 into Q2. Well, their delays have now been resolved and we’re back on track and recognizing revenue as we routinely do as we release lots. So, everything has been resolved.
TY: ”Approx. how much was that amount?”
Paul Lytle: If you straight line our revenues, our projections are about $50-55mm over the FY. So you figure at $12.5mm/qtr, you could assume that last qtr was about $5.5mm in total revenue and it could have been on a straight line basis of about $12mm.
TY: ”If I recall correctly the cost of your new [Avid II “Myford”] facility is also included in cost of contract mfg. as well. So how much of the new facility cost is included in Q2/FY17’s contract mfg costs?”
Steve King: If we're talking about the Myford facility which we commissioned in January of this year, that cost would be included in those numbers. Obviously we're just kind of moving toward a 3rd facility that would primarily be used for clinical production, at least initially, could eventually be commercial as well, but it’s really designed to be a clinical production facility. So those numbers other than where we spent on planning up to this point are not reflected as in the current numbers.
TY: “Re: Bavi, now that we’ve seen some positive pre-clin. data in combination with checkpoint inhibitors and as you outlined earlier, there are a number of collaboration of academic partners. Can you tell us what else is needed to move any potential combination to the clinic and would any of these upcoming trials involve existing academic collaborators?”
Steve King: One of the nice things about the NCCN collaboration, which just to remind everybody was based on a $2mm grant from Peregrine, a lot of which has already been put into the program, but basically the NCCN will oversee all of those 3 clinical studies that will be completed. One of those is in an I-O combination, so it gives us one opportunity already to start looking at kind of an extension if you will of the work we're doing with our collaborators into the clinic and so we can start to validate some of that. In addition, we have interest from other academic collaborators in I-O combinations, so we're currently evaluating those and how those would move forward. So, we're hopeful to have some news in the not too distant future on some of those developments as well. Beyond that, we're really in the process of just looking through the SUNRISE data, identifying what's the best way to identify patients. In addition, some of the other data we can learn from SUNRISE are changes on therapy, the primary hypothesis being that we can take, if you will, immunologically cold tumors and make them hot tumors by breaking down the immunosuppression - that's some of the things that we have an option to learn from the SUNRISE study. Overall, the data from SUNRISE, taken together with the work at Sloan Kettering and our other collaborators, all really build the story very nicely to eventually potentially starting more company-sponsored studies, but that's where the balance of our R&D spend vs. our revenue comes into play. So, whatever studies we start we anticipate would be smaller studies, but ones that will be rich in biomarker-type analysis, which we think will be the key to #1 identifying those successful combinations, but secondly to eventual partnering where we can actually help some of the other drugs that are in development to do better.
TY: ”Thanks again for taking my questions. Looking forward to learn more about these trials in coming months.”

MR. KING’S CLOSING COMMENTS:
I'd like 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. Looking ahead, we are confident in our ability to achieve profitability through cost reduction and revenue growth, while continuing to work with our collaborators to generate the data required to drive partnering and build shareholder value. With that we will now conclude the call. Thank you again.

= = = = = = = = = = = = = = = = = = = = = = = = = = = = = == = = =
12-12-15 PR: Peregrine Pharmaceuticals Reports Financial Results for Second Quarter of FY 2017 and Recent Developments
*Avid Posts Record Revenue of $23.4 Million During Second Quarter FY 2017 with Contracted Backlog of Future Business Currently at $73 Million
*Beta-2 Glycoprotein-1 (B2GP1) Identified as a Biomarker that Correlates with Statistically Significant Improvement in Overall Survival for Patients Receiving the Bavituximab Combination Compared to Chemotherapy Alone from the Phase III SUNRISE Trial
*Multiple Preclinical Presentations Collectively Point to Bavituximab's Ability to Enhance the Efficacy of Checkpoint Inhibitors by Triggering Immune Active Tumor Environment

TUSTIN, Dec. 12, 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 financial results for the second quarter of FY (FY) 2017 ended October 31, 2016, and provided an update on its contract manufacturing business, clinical pipeline and other corporate developments.

Highlights Since July 31, 2016
"The Avid business is on track to continue its revenue growth this FY as we move toward overall profitability within the next 18 months. Our two facilities have the potential to generate in excess of $80 million in revenue, leaving additional capacity for revenue growth beyond FY 2017 revenue guidance," stated Steven W. King, President and CEO of Peregrine. "We are moving forward with our plans to construct a third manufacturing facility, with an eye toward efficiencies that will reduce the overall cost of construction and operation. While this may delay the new facility launch until later in calendar year 2017, we currently have adequate existing capacity to continue meeting the needs of our current clients while also bringing in new customers so we do not expect it to impact our near-term ability to grow top-line revenue as originally planned. Independently, Avid is a successful and growing CDMO business generating significant revenue and one of our key goals going forward is to help ensure that its value is appropriately represented in the market cap of our overall business." Mr. King continued, "During, and subsequent to, the second quarter, we announced a series of important findings, all of which will contribute to our future development of bavituximab. Our ongoing analysis of the Phase III SUNRISE data has revealed a promising biomarker that may give us insight into key patient populations. We are actively evaluating additional potential biomarkers and we hope to identify a profile for patients who will receive therapeutic benefit from treatment with bavituximab. Concurrent with our internal clinical work, our collaborators at NCCN are in the process of initiating trials for three new bavituximab combination treatments, which we expect to begin enrolling patients in the coming months. What is exciting is that the NCCN studies will help build on developments we are seeing from our internal scientists, as well as our collaborators at Duke, Rutgers, and Memorial Sloan Kettering Cancer Center. Together, we presented compelling data supporting our long-standing belief that bavituximab significantly impacts the tumor microenvironment, creating a more immune active environment in which other therapies, including checkpoint inhibitors, are able to have a greater anti-tumor effect. These findings are highly validating and we look forward to continuing our work with these world-class institutions to help guide clinical development."

Avid Bioservices Highlights
"Growing top-line revenue is a key focus and we are pleased to report a 53% improvement in contract manufacturing revenue for the current six-month period compared to the same period last FY. In addition, our revenue guidance for the second quarter was targeted to exceed $20 million and we achieved $23.4 million in contract manufacturing revenue as we worked closely with the third-party testing laboratory to resolve the unexpected delays in testing we encountered during the first quarter. As a result, we reaffirm our manufacturing revenue guidance of between $50 and $55 million for the full FY," stated Paul Lytle, CFO of Peregrine. "We also continued to advance the validation of three separate manufacturing processes related to third-party customer products that could lead to future commercial manufacturing for these products. While these activities generally have a higher cost of manufacturing, which impacted our gross margin during the second quarter, we believe our investment in these products will provide us future revenue opportunities once these products are approved."

The company reaffirms its manufacturing revenue guidance for the full FY 2017 of $50 - $55 million.

Avid's current manufacturing revenue backlog is $73 million, representing estimated future manufacturing revenue to be recognized under committed contracts. This backlog mostly covers revenue to be recognized during the remainder of FY 2017 and FY 2018.

Clinical Development Highlights
Through the ongoing analysis of the Phase III SUNRISE data, Peregrine scientists identified a correlation between overall survival and pre-treatment levels of the biomarker, beta-2 glycoprotein-1 (B2GP1), which we presented at ESMO in October [10-10-16: http://tinyurl.com/hp73njt ]. Data demonstrated that patients with pre-treatment B2GP1 levels between 200 and 240 µg/mL - representing approximately 30% of randomized patients - achieved a statistically significant, 5.5-month improvement, from 7.7 months to 13.2 months, in median overall survival as compared to patients in the control group with the same range of B2GP1 levels.

Peregrine's research collaboration with NCCN is advancing as planned, with grants awarded to three investigators [9-6-16: http://tinyurl.com/gutgwb5 ] 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 over the coming months.

Research Highlights
Peregrine scientists and collaborators from Duke University Medical Center, Rutgers University College of Medicine, and Memorial Sloan Kettering Cancer Center each presented compelling data demonstrating that shifts in the tumor microenvironment from immune suppressed to immune active occurred when a bavituximab equivalent antibody was administered as part of a combination treatment regimen. Presentations addressed multiple phosphatidylserine (PS)-targeting combinations, including those with checkpoint inhibitors such as anti-PD-1, anti-PD-L1 and anti-LAG3, as well as with radiation or chemotherapy. These data suggest that the addition of PS-targeting reverses an immunosuppressive tumor environment, creating an immune active tumor microenvironment that can potentially convert patients that generally do not respond to immuno-oncology (I-O) therapies into responders. Key presentations were made at the Second International Cancer Immunotherapy Conference in September, the American Association for Cancer Research's Tumor Immunology and Immunotherapy Conference in October, the Society for Immunotherapy of Cancer (SITC) in November, and the San Antonio Breast Cancer Symposium in December.

Financial Highlights and Results
Peregrine continues to execute its previously-announced strategy to reach sustained profitability by increasing contract manufacturing revenue while decreasing research and development expenses, with the goal of reaching profitability 18 months from now. During the first six months of FY 2017, the company made significant progress toward this goal with contract manufacturing revenues increasing 53% compared to the first six months of FY 2016 and research and development expenses decreasing by 45% compared to the first six months of FY 2016.

Contract manufacturing revenue from Avid's clinical and commercial biomanufacturing services provided to its third-party customers increased to $23,370,000 for the second quarter of FY 2017 compared to $9,523,000 for the second quarter of FY 2016. In addition, as previously-announced, a backlog at a third-party testing lab, unrelated to product quality, required that the recognition of some revenue be shifted from the first quarter to the second quarter of FY 2017.

Total costs and expenses for the second quarter of FY 2017 were $27,447,000, compared to $23,347,000 for the second quarter of FY 2016. For the second quarter of FY 2017, research and development expenses decreased 51% to $7,022,000, compared to $14,190,000 for the second quarter of FY 2016. Cost of contract manufacturing increased to $15,441,000 in the second quarter of FY 2017 compared to $4,741,000 for the second quarter of FY 2016, primarily due to an increase in the cost of contract manufacturing associated with higher reported revenue. Also contributing to this increase and impacting gross margins for the period is the higher cost of operating the new Myford facility as well as the higher cost associated with performing process validation runs during the quarter. For the second quarter of FY 2017, selling, general and administrative expenses increased to $4,984,000 compared to $4,416,000 for the second quarter of FY 2016 primarily due to the company's growing manufacturing business.

Peregrine's consolidated net loss attributable to common stockholders was $5,498,000 or $0.02 per share, for the second quarter of FY 2017, compared to a net loss attributable to common stockholders of $14,578,000, or $0.07 per share, for the same prior year quarter. [NOTE: Oper. Cash Burn for Q2(q/e 10-31-16): $2.57mm see below.]

Peregrine reported $49,055,000 in cash and cash equivalents as of October 31, 2016, compared to $61,412,000 at FY ended April 30, 2016.

More detailed financial information and analysis may be found in Peregrine's Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.

Conference Call
Peregrine will host a conference call and webcast this afternoon, December 12, 2016, at 4:30PM ET (1:30PM PT). 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 .

PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
THREE MONTHS ENDED
OCTOBER 31, SIX MONTHS ENDED
OCTOBER 31 ,
2016 2015 2016 2015
REVENUES:
Contract manufacturing revenue $ 23,370,000 $ 9,523,000 $ 28,979,000 $ 18,902,000
License revenue — — — 292,000
Total revenues 23,370,000 9,523,000 28,979,000 19,194,000

COSTS AND EXPENSES:
Cost of contract manufacturing 15,441,000 4,741,000 18,503,000 9,349,000
Research and development 7,022,000 14,190,000 15,591,000 28,108,000
Selling, general and administrative 4,984,000 4,416,000 10,044,000 9,315,000
Total costs and expenses 27,447,000 23,347,000 44,138,000 46,772,000

LOSS FROM OPERATIONS (4,077,000 ) (13,824,000 ) (15,159,000 ) (27,578,000 )
Interest and other income 21,000 626,000 46,000 657,000
NET LOSS
$ (4,056,000 ) $ (13,198,000) $ (15,113,000) $ (26,921,000)
COMPREHENSIVE LOSS $ (4,056,000 ) $ (13,198,000 ) $ (15,113,000 ) $ (26,921,000 )

Series E preferred stock accumulated dividends (1,442,000 ) (1,380,000 ) (2,477,000 ) (2,413,000 )
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
$ (5,498,000) $ (14,578,000) $ (17,590,000) $ (29,334,000)

WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:
Basic and Diluted 244,815,767 203,942,411 242,205,428 200,629,892
BASIC AND DILUTED LOSS PER COMMON SHARE $ (0.02 ) $ (0.07 ) $ (0.07 ) $ (0.15 )

PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
OCTOBER 31,
2016 APRIL 30, 2016 Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 49,055,000 $ 61,412,000
Trade and other receivables 6,066,000 2,859,000
Inventories 25,924,000 16,186,000
Prepaid expenses and other current assets 1,711,000 1,351,000
Total current assets 82,756,000 81,808,000
Property and equipment, net 23,957,000 24,302,000
Restricted cash 600,000 600,000
Other assets 2,624,000 2,333,000
TOTAL ASSETS $ 109,937,000 $ 109,043,000
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 11,572,000 $ 8,429,000
Accrued clinical trial and related fees 3,639,000 7,594,000
Accrued payroll and related costs 5,280,000 5,821,000
Deferred revenue 17,980,000 10,030,000
Customer deposits 26,928,000 24,212,000
Other current liabilities 1,012,000 1,488,000
Total current liabilities 66,411,000 57,574,000
Deferred rent, less current portion 1,347,000 1,395,000
Commitments and contingencies

STOCKHOLDERS' EQUITY:
Preferred stock - $0.001 par value; authorized 5,000,000 shares; 1,647,760 and 1,577,440 issued and outstanding at October 31, 2016 and April 30, 2016, respectively 2,000 2,000
Common stock-$0.001 par value; authorized 500,000,000 shares; 251,765,279 and 236,930,485 issued and outstanding at October 31, 2016 and April 30, 2016, respectively 252,000 237,000
Additional paid-in capital 566,314,000 559,111,000
Accumulated deficit (524,389,000 ) (509,276,000 )
Total stockholders' equity 42,179,000 50,074,000
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 109,937,000 $ 109,043,000
Safe Harbor *snip*
CONTACTS:
• 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-Q header: “As of Dec. 8 2016, there were 257,141,534 shares outstanding.”
- - - - - - - - - - - - - - - - -
Latest 10K 4-30-16 iss. 7-14-16 PR: http://tinyurl.com/h8eqtg5 (Cash 4-30-16=$61.4mm)
Latest 10Q 10-31-16 iss. 12-12-16 http://tinyurl.com/j2u2bjk PR: http://tinyurl.com/hhn4gga (Cash 10-31-16=$49.1mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8

= = = = = = = = = = = = = = = = = = = = = = = = = = = =
Updated PPHM REVS-BY-QTR TABLE, now thru FY17'Q2(qe 10-7-31-16), per the 10-31-16 10-Q ( http://tinyurl.com/j2u2bjk ) issued 12-12-16.
• Total Revs since May’06: ($202.5mm/Avid + $24.1mm/Govt + $2.5mm/Lic.) = $229.2mm
• 12-12-16: FY'17 (May'16-Apr'17) Avid revs guidance $50-55mm (Committed B/L=$73mm).
• Deferred-Revs at 10-31-16 total $18.0mm, DOWN from $21.5mm at 7-31-16.
• Cust.Deposits at 10-31-16 total $26.9mm, UP from $21.7mm at 7-31-16.
• Inventories at 10-31-16 total $25.9mm, UP from $25.3mm at 7-31-16.
Avid’s Gross-Profit over last 4 qtrs: $22.3mm on revs of $54.4mm (GP%=41%)
• Recall, Avid Rev$ from Gov’t DTRA Contract work (6/30/08 – 4/15/11, totaling $24.15mm), went into GOVT-REVS, not AVID-REVS, in the Financials.
Avid’s website: http://www.avidbio.com
  
AVID PROFITABILITY (GROSS*) BY QTR:
QTR Avid-Rev$ CostofMfg$ Gross-Profit$ 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%
FY17Q2 10-31-16 23,370,000 15,441,000 7,929,000 34%

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
FY17Q2 10-31-16 23370 0 0 23370 21531 0 25274
Totals: 202548 24149 2453 229150 <=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
FY17Q2 10-31-16 4,056,000

= = = = = = = =
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)
FY17Q2 10-31-16 2,565,000 (Q1+Q2: 12,172,000 10Q pg.24)

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

*The 10-Q’s define OPER.BURN as, ”Net cash used in operating activities before chgs. in operating assets & liabilities”.
The 7-21-2001 10Q explains OP.BURN very nicely:
“RESULTS OF OPERATIONS. Before we discuss the Company's total expenses (cash & non-cash expenses), we would like to discuss the Company's operational burn rate (cash expenses used in operations, net of interest and other income) for q/e July 31, 2001 compared to the same period in the prior year. The operational burn rate is calculated by taking the net income (loss) from operations and subtracting all non-cash items, such as the recognition of deferred license revenue, depreciation and amortization and stock-based compensation expense.”
 
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%
Q/E 10-31-16 77% 10% 13%

- - - - - - - - PPHM’s Fiscal Qtr’s (FY runs May – April):
FY’10-Q3 = q/e 1-31-10 – rep. 3-11-10 Thu (B4 mkt)
FY’10-Q4 = q/e 4-30-10 – rep. 7-14-10 Wed (after mkt)
FY’11-Q1 = q/e 7-31-10 – rep. 9-9-10 Thu (after mkt)
FY’11-Q2 = q/e 10-31-10 – rep. 12-9-10 Thu (after mkt)
FY’11-Q3 = q/e 1-31-10 – rep. 3-11-11 Fri (after mkt)
FY’11-Q4 = q/e 4-30-11 – rep. 7-14-11 Thu (after mkt)
FY’12-Q1 = q/e 7-31-11 – rep. 9-9-11 Fri (B4 mkt)
FY’12-Q2 = q/e 10-31-11 – rep. 12-12-11 Mon (after mkt)
FY’12-Q3 = q/e 1-31-12 – rep. 3-9-12 Fri (after mkt)
FY’12-Q4 = q/e 4-30-12 – rep. 7-16-12 Mon (after mkt)
FY’13-Q1 = q/e 7-31-12 – rep. 9-10-12 Mon (B4 mkt)
FY’13-Q2 = q/e 10-31-12 – rep. 12-10-12 Mon (after mkt)
FY’13-Q3 = q/e 1-31-13 – rep. 3-12-13 Tue (after mkt)
FY’13-Q4 = q/e 4-30-13 – rep. 7-11-13 Thu (after mkt)
FY’14-Q1 = q/e 7-31-13 – rep. 9-9-13 Mon (after mkt)
FY’14-Q2 = q/e 10-31-13 – rep. 12-10-13 Tue (after mkt)
FY’14-Q3 = q/e 1-31-14 – rep. 3-7-14 Fri (B4 mkt)
FY’14-Q4 = q/e 4-30-14 – rep. 7-14-14 Mon (after mkt)
FY’15-Q1 = q/e 7-31-14 – rep. 9-9-14 Tue (after mkt)
FY’15-Q2 = q/e 10-31-14 – rep. 12-10-14 Wed (after mkt)
FY’15-Q3 = q/e 1-31-15 – rep. 3-12-15 Thu (after mkt)
FY’15-Q4 = q/e 4-30-15 – rep. 7-14-15 Tue (after mkt)
FY’16-Q1 = q/e 7-31-15 – rep. 9-9-15 Wed (after mkt)
FY’16-Q2 = q/e 10-31-15 – rep. 12-10-15 Thu (after mkt)
FY’16-Q3 = q/e 1-31-16 – rep. 3-9-16 Wed (B4 mkt)
FY’16-Q4 = q/e 4-30-16 – rep. 7-14-16 Thu (after mkt)
FY’17-Q1 = q/e 7-31-16 – rep. 9-8-16 Thu (after mkt)
FY’17-Q2 = q/e 10-31-16 – rep. 12-12-16 Mon (after mkt)

= = = = = = = = = = = =
“Going Concern” statement ELIMINATED from 4-30-13 10-K issued 7-11-2013…
2012: 4-30-12 10-K iss. 7-16-12 http://tinyurl.com/79o57b2
Pg.68: “As more fully described in Note 2, the Company’s recurring losses from operations and recurring negative cash flows from operating activities raise substantial doubt about its ability to continue as a going concern.”
2013 & 2014 & 2015 10-K's: http://tinyurl.com/p58jcbw etc...=> ((((NO GOING CONCERN STATEMENT INCLUDED.))))
CASH a/o 4-30-13: $35.2mm
CASH a/o 6-30-13: $42.6mm
CASH a/o 7-31-13: $41.6mm
CASH a/o 10-31-13: $44.4mm
CASH a/o 1-31-14: $63.2mm
CASH a/o 2-15-14: $79.7mm
CASH a/o 4-30-14: $77.5mm
CASH a/o 6-30-14: $78.3mm
CASH a/o 7-31-14: $73.3mm
CASH a/o 10-31-14: $64.4mm
CASH a/o 1-31-15: $55.2mm
CASH a/o 4-30-15: $68.0mm
CASH a/o 7-31-15: $59.0mm
CASH a/o 10-31-15: $72.0mm
CASH a/o 1-31-16: $67.5mm
CASH a/o 4-30-16: $61.4mm
CASH a/o 7-31-16: $44.2mm
CASH a/o 10-31-16: $49.1mm
= = = = = = = = = = A look at #Employees per the 10K’s…
2011 10-K: "As of 4-30-11, we employed 154 full-time emps & 2 part-time emps”
2012 10-K: "As of 4-30-12, we employed 172 full-time emps & 2 part-time emps."
2013 10-K: "As of 4-30-13, we employed 182 full-time emps & 5 part-time emps."
2014 10-K: "As of 4-30-14, we employed 180 full-time emps & 4 part-time emps."
2015 10-K: "As of 4-30-15, we employed 211 full-time emps & 4 part-time emps."
2016 10-K: "As of 4-30-16, we employed 281 full-time emps & 3 part-time emps."