Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
The gist of Sunstar's earlier post...
"Here's what I see (re: Avid):
In Avid I see a fast growing state of the art biopharmaceutical manufacturing facility, capable of producing some of the most sophisticated substances in the pharma world. I see an expanding facility capacity that can now produce many millions of dollars of third party products for its contracted customers. I also see a forecast of doubling and more of that revenue through the expanding facilities.
I think, most importantly, we see an FDA approved facility capable of producing in house MAbs like Bavituximab and Betabodies. This manufacturing capability and, especially capacity, is an FDA requirement for launching a commercially FDA approved biologic like Bavi. We have to realize that when Avid, wholly owned by Peregrine, manufactures Bavituximab for commercial treatment of cancers, we are talking about a much higher valuation for Peregrine itself. Bavi is likely to cost patients or their insurers, something in the order of $100,000 to $120,000 per full course treatment. This is an Avid valuation upgrade for those not satisfied with a measly $40,000,000 and growing annual revenue stream, because major product will be TALCEPTRX.
Peregrine has recently obtained a Trade Mark, TALCEPTRX, for the commercial use of Bavituximab. To maintain this Trade Mark, Peregrine needs to have TALCEPTRX (Bavi) on the market within a 6-month window. According to CP, who found this "ihub PR", Peregrine was pursuing this trade mark name even after they stopped SUNRISE, so they have reason to believe that Bavi will be FDA approved in the near term.
I think that Bavi, in the SUNRISE P3 NSCLC trial performed as was expected, and that Peregrine ran the SUNRISE P3 trial with an intent to obtain FDA approval. Peregrine had a depth of double blind Bavi/Doce data for its FDA presentation study, and thereby knew that they would need the trade mark, TALCEPTRX.
I have also seen the recent NCCN document that states the existence of two planned I-O trials. One is with AstraZeneca combining Bavi with Durvalumab in NSCLC, and a second trial combining Bavi with Merck's Keytruda for treating liver cancer. This is another example of something we would not have seen yet if it were not for the document being made available here on ihub by?? I don't know who originally provided this to the board.
Peregrine, through TexSW, has human I-O data for Bavi plus Yervoy. According to the ASCO 2016 abstract, Peregrine has human dosing data on Bavi combined with Durvalumab. This too has yet to be PR'd in data form, but may be being shared at negotiating tables, of which we are also not privy to at this point.
So, in short, Avid is worth a heck of a lot more than its 3rd party production evaluation.
Peregrine has a trade mark TALCEPTRX that is already into a 6-month (must use commercially) window.
Peregrine has reasons to want this trade mark in place in the near term.
Peregrine has a body of Double Blind data from 2nd line NSCLC clinical trials.
Peregrine has human cancer data of Bavi in I-O combinations.
Bavi is involved with an AZN I-O combination trial, and in another combination I-O trial with Merck's Keytruda.
IMO"
ABOUT PEREGRINE Section Revamped… To me, just clearer language. June2 said Avid “provides development & biomanufacturing services for both Peregrine and 3rd-party customers”, which is repeated today, but a new classification term was used today for Avid, CMDO = Contract Development & Manufacturing Organization.
7-7-16 10K/CC COMING THUR. 7-14-16 AFTER MKT:
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. For more information, please visit http://www.peregrineinc.com .
6-2-16 CORP-UPDATE PR: http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=973959
ABOUT PEREGRINE PHARMACEUTICALS, INC.
Peregrine Pharmaceuticals, Inc. is a company focused on continued revenue growth from its contract manufacturing business and developing its novel immuno-oncology products. The company is working to evaluate its lead immunotherapy candidate, bavituximab, in combination with a range of novel immuno-oncology (I-O) agents for the treatment of various cancers. Peregrine's in-house cGMP manufacturing 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. For more information, please visit http://www.peregrineinc.com .
= = = = =
CMO = Contract Manufacturing Organization
CMDO = Contract Development & Manufacturing Organization
“Theoretically, the CDMO is positioned for a strategic partnership, with expertise in areas the drug innovator seeks, whereas the CMO may be viewed as a tactical provider that has the available capacity to compete for the project. This perception has influenced many contract manufacturers to embrace the CDMO term as an additional advantage in the effort to develop long-term partnerships.”
http://www.niceinsight.com/articles.aspx?post=998&title=the+cdmo+model+and+outsourcing+development
Q4 Avid revs doubling prev. record to $18.4mm - can't see that going to Friday After. http://investorshub.advfn.com/boards/read_msg.aspx?message_id=123652099
I really said ~7/12/16 - ie, IF same timing as last year's July CC (7/14/15, TUE. after Mkt).
The ~7-12-16 10K/CC may be well-received when Avid revs for Q4(qe 4-30-16) come in at $18.4mm, almost double the previous record. This was implied (via mathematics) in the 6-2-16 Corp-Update PR, but many may have either not seen that PR, or may not have realized the implications of the statement, “FY16 AVID REVS will be $44mm”...
AVID REVENUES/GROSS PROFIT ESCALATION PER THE 6-2-16 PR
6-2-16: Corp.Update – Avid Expansion & Drug Development - http://tinyurl.com/zvmhqmr
...Avid Revs for FY'16(fye 4-30-16) will be $44mm; B/L=$56M; FY17/guidance=$50-55mm(3 curr. clients). Avid III being designed/already secured 25,000sf loc/expect complete=1H/2017. “Expect future sustainable profitability for the company in 24mos.”
**GP% est. at 48%, which is ACTUAL for the 3Qtrs ended 1-31-16, latest 10Q's
**FY'16/Actual (fye 4-30-16): Revs=$44.0mm, Gross-Profit=$21.2mm <=ie, Q4(qe4-30-16) revs=$18.4mm
**FY'17/Guidance (fye 4-30-17): Revs=$52mm, Gross-Profit=$25.0mm
**WHEN AVID II (“Myford” +$40mm) at Full Capacity: Revs=$88mm, Gross-Profit=~$42.2mm
**WHEN AVID III (25000sq Facility per 6-2-16 PR +$30mm) at Full Capacity: Revs=$118mm, Gross-Profit=~$56.6mm
- - - - - -
AVID PROFORMA – Based on 6-2-16 PR (FY'16/fye=4-30-16 Revs will be: $44mm)...
Updated PPHM REVS-BY-QTR TABLE, now thru FY16'Q4(fye 4-30-16), per the 6-2-16 Corp. update PR ( http://tinyurl.com/zntvudj ):
• Total Revs since May’06: ($173.2mm/Avid + $24.1mm/Govt + $2.5mm/Lic.) = $199.8mm
• 6-2-16: FY'17 (May'16-Apr'17) Avid revs guidance raised to $50-55mm.
• Avid’s Gross-Profit over last 4 qtrs: $21.2mm on revs of $44.0mm (GP%=48%)
• Recall, Avid Rev$ from Gov’t DTRA Contract work (6/30/08 – 4/15/11, totaling $24.15mm), went into GOVT-REVS, not AVID-REVS, in the Financials.
Avid’s website: http://www.avidbio.com
AVID PROFITABILITY (GROSS*) BY QTR:
QTR Avid-Rev$ CostofMfg$ Gross-Profit$ GP%
FY13Q1 7-31-12 4,135,000 2,024,000 2,111,000 51%
FY13Q2 10-31-12 6,061,000 3,703,000 2,358,000 39%
FY13Q3 1-31-13 6,961,000 3,651,000 3,310,000 47%
FY13Q4 4-30-13 4,176,000 3,217,000 959,000 23%
FY14Q1 7-31-13 4,581,000 2,670,000 1,911,000 42%
FY14Q2 10-31-13 7,354,000 4,195,000 3,159,000 43%
FY14Q3 1-31-14 3,885,000 2,416,000 1,469,000 38%
FY14Q4 4-30-14 6,474,000 3,829,000 2,645,000 41%
FY15Q1 7-31-14 5,496,000 3,583,000 1,913,000 35%
FY15Q2 10-31-14 6,263,000 4,139,000 2,124,000 34%
FY15Q3 1-31-15 5,677,000 3,113,000 2,564,000 45%
FY15Q4 4-30-15 9,308,000 4,758,000 4,550,000 49%
FY16Q1 7-31-15 9,379,000 4,608,000 4,771,000 51%
FY16Q2 10-31-15 9,523,000 4,741,000 4,782,000 50%
FY16Q3 1-31-16 6,672,000 3,896,000 2,776,000 42%
FY16Q4 4-30-16 18,400,000 9,600,000 8,800,000 ~48% <=Per 6-2-16 PR
FY13 TOTAL: 21,333,000 12,595,000 8,738,000 41%*
FY14 TOTAL: 22,294,000 13,110,000 9,184,000 41%*
FY15 TOTAL: 26,744,000 15,393,000 11,151,000 42%*
FY16 TOTAL: 44,000,000 22,800,000 21,200,000 ~48%*
*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 18400 0 0 18400 ?? 0 ??
Totals: 173186 24149 2453 199788 <=since5/1/2006
6-27-16: Medtronic to Acquire of HeartWare Intl. For $58/sh.
http://ir.heartware.com/phoenix.zhtml?c=187755&p=irol-newsArticle&ID=2180056
6-27-16: Medtronic plc (NYSE: MDT), the global leader in medical technology, and HeartWare International, Inc. (NASDAQ: HTWR), a leading innovator of less-invasive, miniaturized circulatory support technologies for the treatment of advanced heart failure, today announced that the companies have entered into a definitive merger agreement under which Medtronic will acquire HeartWare in a transaction valued at approx. $1.1 billion. Under the terms of the agreement, Medtronic will commence a tender offer for all outstanding shares of HeartWare common stock for $58.00 per share, in cash. The boards of directors of both Medtronic & HeartWare have unanimously approved the transaction. The acquisition is expected to close during Medtronic's 2nd fiscal qtr ending Oct. 28, 2016, subject to the satisfaction of customary closing conditions…
4Our, the Nasdaq Summary Quote shows Vol=19,165,412: http://www.nasdaq.com/symbol/pphm
...I do see that 31,536,766 on the “Real Time” page, http://www.nasdaq.com/symbol/pphm/real-time - probably some sort of IT problem with that page IMO – maybe that one never got fixed when they stopped the double-counting.
Lisa Stepp (PhD, Sen.Dir/MedicalAffairs) speaking 9-15-16 at Medical-Affairs-Forum
Sept14-16 2016: “EXL's 11th Medical Affairs Executive Forum”, SanDiego
http://exlevents.com/medical-affairs-executive-forum-west
“The role of medical affairs teams in the life science industry has seen an expansion of functionality & responsibility, especially with easier access to information through digital platforms. A primary focus for medical affairs leadership is to ensure the compliant separation of clinical & commercial teams, particularly regarding their access to therapeutic area experts. Communication channel mgt. will serve as one of the driving themes for the Medical Affairs Strategic Summit (MASS) West 2016...”
9-15-16 11:15–12pm: “The Effects of Company Size on the Establishment of an Advisory Board Benchmark” - Lisa Stepp, PhD, Sen.Dir./Medical Affairs, Peregrine Pharmaceuticals
- - - -
Lisa Stepp (PhD/MBA) joined Peregrine 3-2015 as “Sr. Dir./Medical Affairs” - formerly with Gilead, Allos, Genentech, and Wyeth.
https://www.linkedin.com/in/lisa-stepp-phd-mba-345942a
= = = = = = = = = = = = = =
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.”
5-31-15: ASCO’15 Roundtable (webcast), “Raising the Immuno-Oncology Bar” - 7 panel members, incl. 3 Mem. Sloan Kettering researchers http://tinyurl.com/qxu4w2x
BAVI MOA 3-25-14: Dr. Rolf Brekken’s 40min talk at NYAS Lung Cancer Symposium http://tinyurl.com/lq9stnk (45 Slides)
. . .Dr.Brekken’s talk: “Antibody-mediated Inhibition of PS - A Novel Strategy for Immune Checkpoint Blockade” (the 5 speakers: Jessica Donington, Roy Herbst, Balazs Halmos, Suresh Ramalingam, Rolf Brekken)
12-10-13: With recent scientific insights highlighting bavi’s immunostimulatory moa, these additions to PPHM’s SAB: Dimitry Gabrilovich, Scott Antonia, David Carbone**, Hakan Mellstedt http://tinyurl.com/mw776mk
......**A/o 9-2015, Dr. David Carbone (PPHM SAB/KOL) is President of IASLC https://www.iaslc.org/about-us/board
http://www.peregrineinc.com/about-us/medical-and-scientific-advisors.html
Stoney, I think those listed on the Clinical-Trials page are actually-initiated trials or specifically confirmed/planned trials (ie, AZN Ph1 Solids - see below) going forward. Future (at this point undefined Bavi drug combo's & indications) trials, like the upcoming NCCN's, are described on the Pipeline overview page:
http://www.peregrineinc.com/pipeline/bavituximab-oncology.html
From 6-2-16/PR: Corp.Update – http://tinyurl.com/zvmhqmr
"The company continues to evaluate data from the SUNRISE trial in order to collect information that can best inform the ongoing clinical development of bavituximab. As part of these efforts, Peregrine is working closely with AstraZeneca to identify the optimal strategy for the companies' clinical development collaboration focused on combining bavituximab with AstraZeneca's PD-L1 inhibitor, durvalumab. It is expected that the initial trial in the collaboration will be a Phase I study evaluating the treatment combination in a range of solid tumors. The expected timing of initiation of any trial will be determined by the continued collection of data from the SUNRISE trial and finalization of the trial design."
6-3-16: FBR’s Thomas Yip reiterated an Outperform rating on shares of PPHM (PT=$1.00), after the drug maker reported a preliminary financial update of the company and its wholly owned bio-manufacturing subsidiary, Avid Bioservices [ http://tinyurl.com/zvmhqmr ]. Yip stated, “This financial update reaffirmed our belief that Avid will continue its organic growth, and we continue to think that Avid will remain a valuable source of non-dilutive cash flow for Peregrine as the company continues to explore opportunities to develop its lead asset, bavituximab, as a treatment combination with immuno-oncology agents. We also think Peregrine would not require addl. financing in the near term, as it reported a pro forma cash balance of $61mm as of April 30.”
http://www.smarteranalyst.com/2016/06/03/biotech-beat-fbr-analysts-weigh-galena-biopharma-inc-gale-peregrine-pharmaceuticals-pphm-immune-pharmaceuticals-inc-imnp
= = = = = =
6-2-16/PR: Corp.Update – Avid Expansion & Drug Development - Avid revs for FY16(fye 4-30-16) will be $44mm; since $25.6mm for 1st 3 qtrs, Q4 revs will be ~$18.4mm. Avid B/L currently $56M; guidance for FY17(fye 4-30-17) is $50-55mm. Avid II (Myford) is currently ramping up for runs for “3 current clients”. Peregrine is “in the process of designing a 3rd mfg. Facility focused on clinical manufacturing”; has already secured a 25,000sf location, and “expects the new clinical suite to be complete & ready for clinical mfg. by 1H/2017.” ...All this leads to Peregrine expecting, "future sustainable profitability for the company in 24 months".
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=123067949
6-2-16/PR: Corp.Update – Avid Expansion & Drug Development - Avid revs for FY16(fye 4-30-16) will be $44mm; since $25.6mm for 1st 3 qtrs, Q4 revs will be ~$18.4mm. Avid B/L currently $56M; guidance for FY17(fye 4-30-17) is $50-55mm. Avid II (Myford) is currently ramping up for runs for “3 current clients”. Peregrine is “in the process of designing a 3rd mfg. Facility focused on clinical manufacturing”; has already secured a 25,000sf location, and “expects the new clinical suite to be complete & ready for clinical mfg. by 1H/2017.” ...All this leads to Peregrine expecting, "future sustainable profitability for the company in 24 months".
- - - - - - - - - - - -
6-2-16: Peregrine Pharmaceuticals Provides Corporate Update Highlighting Latest Developments for Contract Manufacturing and Drug Development Businesses
*Contract Manufacturing Revenue Hits All-Time High of $44mm for FY Ended April 2016; FY 2017 Contract Manufacturing Revenue Projected Between $50-55 Million; Continued Growth Expected to Lead to Future Sustainable Profitability in 24 Months
*Drug Development Strategy to Focus on Early Stage Clinical Trials of Bavituximab and Immuno-Oncology (I-O) Combinations
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=973959
TUSTIN, June 2, 2016: Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM/PPHMP), a company focused on continued revenue growth from its contract manufacturing business and developing its novel immuno-oncology products, today provided a corporate update highlighting the company's operational strategies and latest developments. The company's contract manufacturing subsidiary, Avid Bioservices, continues to experience significant organic growth, generating $44 million in revenue for fiscal year (FY) 2016 compared to $26.7 million in contract manufacturing revenue in FY 2015. Peregrine expects to continue to have double digit contract manufacturing revenue growth, and for FY 2017, the company is providing revenue guidance of $50-55 million for Avid, due in part to the revenue backlog of $56 million under committed contracts from existing clients. Peregrine expects this trend, driven by increasing client demand and several ongoing expansion initiatives, to lead to future sustainable profitability for the company in 24 months.
"The past several months have been a busy and productive time at Peregrine as we work to optimally position the company for future success with both our contract manufacturing and drug development businesses. We are very pleased that Avid exceeded its revenue projections for FY2016 and excited for what we expect will be continued growth for that business," said Steven W. King, President and CEO of Peregrine. "At the same time, we continue to work to advance our phosphatidylserine (PS)-targeting platform. In order to move toward overall profitability while continuing to generate valuable clinical data, we will focus our future development efforts on small, early stage clinical trials evaluating combinations of bavituximab and immuno-oncology (I-O) agents. This strategy will be supported through our current and future collaborations, which we believe will efficiently generate the clinical data required to identify and pursue the most valuable opportunities for bavituximab."
CONTRACTING MANUFACTURING HIGHLIGHTS:
Avid Bioservices exceeded its full FY 2016 revenue target of $40 million, generating $44 million in contract manufacturing revenue.
The company today announced full FY 2017 revenue guidance for Avid Bioservices of $50-55 million.
Avid currently has a revenue backlog of $56 million under committed contracts from existing clients.
The recently commissioned second manufacturing facility [“Myford”] has completed its initial process validation runs and is ramping up to conduct multiple new process validation runs for three current clients. Process validation is a critical element in preparing a facility to launch commercial manufacturing activities. As such, this milestone moves Peregrine a key step closer to realizing revenue from commercial production from this new manufacturing suite.
Based on significant client demand, Peregrine is in the process of designing a third manufacturing facility focused on clinical manufacturing. This suite will significantly increase the company's manufacturing capacity, with the potential to generate up to $30 million in additional revenue annually. The company has secured a 25,000 square foot location in close proximity to its current campus and expects the new clinical suite to be complete and ready for clinical manufacturing activities by the first half of calendar 2017.
In continued efforts to evolve into a fully integrated manufacturing business capable of efficiently meeting all of its clients' needs, Peregrine is in the process of exploring additional service expansion opportunities.
DRUG DEVELOPMENT HIGHLIGHTS:
The company will pursue a clinical development strategy focused on conducting small, early stage studies of bavituximab in combination with I-O agents. These trials may be conducted as part of ongoing collaborations with AstraZeneca and the National Comprehensive Cancer Network (NCCN). The goal of these trials will be to generate compelling data capable of driving partnering interest. As part of this new strategy, the company has discontinued plans to initiate further Phase II and Phase III trials.
The company continues to evaluate data from the SUNRISE trial in order to collect information that can best inform the ongoing clinical development of bavituximab. As part of these efforts, Peregrine is working closely with AstraZeneca to identify the optimal strategy for the companies' clinical development collaboration focused on combining bavituximab with AstraZeneca's PD-L1 inhibitor, durvalumab. It is expected that the initial trial in the collaboration will be a Phase I study evaluating the treatment combination in a range of solid tumors. The expected timing of initiation of any trial will be determined by the continued collection of data from the SUNRISE trial and finalization of the trial design.
Peregrine's research collaboration with the NCCN, a not-for-profit alliance of 27 of the world's leading cancer centers, is underway. The NCCN is currently accepting proposals from its member institutions and their affiliate community hospitals to conduct clinical trials combining bavituximab with I-O agents for the treatment of a range of cancers. It is expected that between two and five different clinical studies will be conducted as part of this collaboration, potentially providing Peregrine with a wealth of valuable human data to steer future development of bavituximab. While specific timing has not been established, it is expected that the first studies will be initiated in late calendar year 2016 or early 2017.
Peregrine's ongoing preclinical research collaboration with Memorial Sloan Kettering Cancer Center (MSKCC) continues to progress as planned. Researchers at MSKCC are evaluating novel combinations of bavituximab and other relevant I-O therapeutic approaches including checkpoint inhibitors, adoptive T-cell therapy and oncogenic virus, in multiple preclinical cancer models. Initial data from these studies is expected to be presented at scientific conferences later in calendar year 2016.
FINANCIAL STRENGTH SUPPORTING ONGOING ACTIVITIES
Peregrine remains in a strong financial position to continue to execute against its operational strategies for its contract manufacturing and drug developments businesses. As of April 30, 2016, the company had $61 million in cash and cash equivalents.
ABOUT BAVITUXIMAB: A TARGETED INVESTIGATIONAL IMMUNOTHERAPY
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 company focused on continued revenue growth from its contract manufacturing business and developing its novel immuno-oncology products. The company is working to evaluate its lead immunotherapy candidate, bavituximab, in combination with a range of novel immuno-oncology (I-O) agents for the treatment of various cancers. Peregrine's in-house cGMP manufacturing 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. For more information, please visit http://www.peregrineinc.com .
Safe Harbor *snip*
Contacts:
Jay Carlson, Peregrine Pharmaceuticals, Inc. (800) 987-8256 info@peregrineinc.com
Stephanie Diaz (Investors), Vida Strategic Partners 415-675-7401 sdiaz@vidasp.com
Tim Brons (Media), Vida Strategic Partners 415-675-7402 tbrons@vidasp.com
= = = = = = = = = = = = = = = = = =
AVID REVENUES/GROSS PROFIT ESCALATION PER THE 6-2-16 PR
(GP% est. at 48%, which is ACTUAL for the 3Qtrs ended 1-31-16, latest 10Q's)
FY'16/Actual (fye 4-30-16): Revs=$44.0mm, Gross-Profit=$21.2mm
FY'17/Guidance (fye 4-30-17): Revs=$52mm, Gross-Profit=$25.0mm
WHEN AVID II (“Myford” +$40mm) at Full Capacity: Revs=$88mm, Gross-Profit=$42.2mm
WHEN AVID III (25000sq Facility per 6-2-16 PR +$30mm) at Full Capacity: Revs=$118mm, Gross-Profit=$56.6mm
= = = = = = = = = = = = = = = = = = = = = = = = = = = =
AVID PROFORMA – Based on 6-2-16 PR (FY16 Revs will be: $44mm)...
Updated PPHM REVS-BY-QTR TABLE, now thru FY16'Q4(fye 4-30-16), per the 6-2-16 Corp. update PR ( http://tinyurl.com/zntvudj ):
• Total Revs since May’06: ($173.2mm/Avid + $24.1mm/Govt + $2.5mm/Lic.) = $199.8mm
• 6-2-16: FY'17 (May'16-Apr'17) Avid revs guidance raised to $50-55mm.
• Avid’s Gross-Profit over last 4 qtrs: $21.2mm on revs of $44.0mm (GP%=48%)
• Recall, Avid Rev$ from Gov’t DTRA Contract work (6/30/08 – 4/15/11, totaling $24.15mm), went into GOVT-REVS, not AVID-REVS, in the Financials.
Avid’s website: http://www.avidbio.com
AVID PROFITABILITY (GROSS*) BY QTR:
QTR Avid-Rev$ CostofMfg$ Gross-Profit$ GP%
FY13Q1 7-31-12 4,135,000 2,024,000 2,111,000 51%
FY13Q2 10-31-12 6,061,000 3,703,000 2,358,000 39%
FY13Q3 1-31-13 6,961,000 3,651,000 3,310,000 47%
FY13Q4 4-30-13 4,176,000 3,217,000 959,000 23%
FY14Q1 7-31-13 4,581,000 2,670,000 1,911,000 42%
FY14Q2 10-31-13 7,354,000 4,195,000 3,159,000 43%
FY14Q3 1-31-14 3,885,000 2,416,000 1,469,000 38%
FY14Q4 4-30-14 6,474,000 3,829,000 2,645,000 41%
FY15Q1 7-31-14 5,496,000 3,583,000 1,913,000 35%
FY15Q2 10-31-14 6,263,000 4,139,000 2,124,000 34%
FY15Q3 1-31-15 5,677,000 3,113,000 2,564,000 45%
FY15Q4 4-30-15 9,308,000 4,758,000 4,550,000 49%
FY16Q1 7-31-15 9,379,000 4,608,000 4,771,000 51%
FY16Q2 10-31-15 9,523,000 4,741,000 4,782,000 50%
FY16Q3 1-31-16 6,672,000 3,896,000 2,776,000 42%
FY16Q4 4-30-16 18,400,000 9,600,000 8,800,000 48% <=Per 6-2-16 PR
FY13 TOTAL: 21,333,000 12,595,000 8,738,000 41%*
FY14 TOTAL: 22,294,000 13,110,000 9,184,000 41%*
FY15 TOTAL: 26,744,000 15,393,000 11,151,000 42%*
FY16 TOTAL: 44,000,000 22,800,000 21,200,000 48%*
*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 18400 0 0 18400 ?? 0 ??
Totals: 173186 24149 2453 199788 <=since5/1/2006
Vaness, 4-30-16 already occurred. => Avid’s Gross-Profit over last 4 qtrs ending 4-30-16: $21.1mm on revs of $44.0mm (GP%=48%)
Please reread:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=123052656
Proforma Chart on Avid Revs/GrossProfitability Q4/FY16(fye 4-30-16)
From the 6-2-16 Corp. update PR ( http://tinyurl.com/zntvudj ):
Avid revs for FY16(fye 4-30-16) will be $44mm; since $25.6mm for 1st 3 qtrs, Q4 revs will be ~$18.4mm. Avid B/L currently $56M; guidance for FY17(fye 4-30-17) is $50-55mm. Avid II (Myford) is currently ramping up for runs for “3 current clients”. Peregrine is “in the process of designing a 3rd mfg. Facility focused on clinical manufacturing”; has already secured a 25,000sf location, and “expects the new clinical suite to be complete & ready for clinical mfg. by 1H/2017.” ...All this leads to Peregrine expecting, "future sustainable profitability for the company in 24 months".
= = = = = = = = = = = = = = = = = = = = = = = = = = = =
AVID PROFORMA – Based on 6-2-16 PR (FY16 Revs will be: $44mm)...
Updated PPHM REVS-BY-QTR TABLE, now thru FY16'Q4(fye 4-30-16), per the 6-2-16 Corp. update PR ( http://tinyurl.com/zntvudj ):
• Total Revs since May’06: ($173.2mm/Avid + $24.1mm/Govt + $2.5mm/Lic.) = $199.8mm
• 6-2-16: FY'17 (May'16-Apr'17) Avid revs guidance raised to $50-55mm.
• Avid’s Gross-Profit over last 4 qtrs ending 4-30-16: $21.1mm on revs of $44.0mm (GP%=48%)
• Recall, Avid Rev$ from Gov’t DTRA Contract work (6/30/08 – 4/15/11, totaling $24.15mm), went into GOVT-REVS, not AVID-REVS, in the Financials.
Avid’s website: http://www.avidbio.com
AVID PROFITABILITY (GROSS*) BY QTR:
QTR Avid-Rev$ CostofMfg$ Gross-Profit$ GP%
FY13Q1 7-31-12 4,135,000 2,024,000 2,111,000 51%
FY13Q2 10-31-12 6,061,000 3,703,000 2,358,000 39%
FY13Q3 1-31-13 6,961,000 3,651,000 3,310,000 47%
FY13Q4 4-30-13 4,176,000 3,217,000 959,000 23%
FY14Q1 7-31-13 4,581,000 2,670,000 1,911,000 42%
FY14Q2 10-31-13 7,354,000 4,195,000 3,159,000 43%
FY14Q3 1-31-14 3,885,000 2,416,000 1,469,000 38%
FY14Q4 4-30-14 6,474,000 3,829,000 2,645,000 41%
FY15Q1 7-31-14 5,496,000 3,583,000 1,913,000 35%
FY15Q2 10-31-14 6,263,000 4,139,000 2,124,000 34%
FY15Q3 1-31-15 5,677,000 3,113,000 2,564,000 45%
FY15Q4 4-30-15 9,308,000 4,758,000 4,550,000 49%
FY16Q1 7-31-15 9,379,000 4,608,000 4,771,000 51%
FY16Q2 10-31-15 9,523,000 4,741,000 4,782,000 50%
FY16Q3 1-31-16 6,672,000 3,896,000 2,776,000 42%
FY16Q4 4-30-16 18,400,000 9,600,000 8,800,000 48%
FY13 TOTAL: 21,333,000 12,595,000 8,738,000 41%*
FY14 TOTAL: 22,294,000 13,110,000 9,184,000 41%*
FY15 TOTAL: 26,744,000 15,393,000 11,151,000 42%*
FY16 TOTAL: 44,000,000 22,800,000 21,200,000 48%*
*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 18400 0 0 18400 ?? 0 ??
Totals: 173186 24149 2453 199788 <=since5/1/2006
6-2-16/PR: Peregrine Provides Corp.Update - Avid & DrugDev. Avid revs for FY16(fye 4-30-16) will be $44mm; since $25.6mm for 1st 3 qtrs, Q4 revs will be ~$18.4mm. Avid B/L currently $56M; guidance for FY17(fye 4-30-17) is $50-55mm. Peregrine is “in the process of designing a 3rd mfg. Facility focused on clinical manufacturing”; has already secured a 25,000sf location, and “expects the new clinical suite to be complete & ready for clinical mfg. by 1H/2017.” ...All this leads to Peregrine expecting, "future sustainable profitability for the company in 24 months"
6-2-16: Peregrine Pharmaceuticals Provides Corporate Update Highlighting Latest Developments for Contract Manufacturing and Drug Development Businesses
*Contract Manufacturing Revenue Hits All-Time High of $44mm for FY Ended April 2016; FY 2017 Contract Manufacturing Revenue Projected Between $50-55 Million; Continued Growth Expected to Lead to Future Sustainable Profitability in 24 Months
*Drug Development Strategy to Focus on Early Stage Clinical Trials of Bavituximab and Immuno-Oncology (I-O) Combinations
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=973959
TUSTIN, June 2, 2016: Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM/PPHMP), a company focused on continued revenue growth from its contract manufacturing business and developing its novel immuno-oncology products, today provided a corporate update highlighting the company's operational strategies and latest developments. The company's contract manufacturing subsidiary, Avid Bioservices, continues to experience significant organic growth, generating $44 million in revenue for fiscal year (FY) 2016 compared to $26.7 million in contract manufacturing revenue in FY 2015. Peregrine expects to continue to have double digit contract manufacturing revenue growth, and for FY 2017, the company is providing revenue guidance of $50-55 million for Avid, due in part to the revenue backlog of $56 million under committed contracts from existing clients. Peregrine expects this trend, driven by increasing client demand and several ongoing expansion initiatives, to lead to future sustainable profitability for the company in 24 months.
"The past several months have been a busy and productive time at Peregrine as we work to optimally position the company for future success with both our contract manufacturing and drug development businesses. We are very pleased that Avid exceeded its revenue projections for FY2016 and excited for what we expect will be continued growth for that business," said Steven W. King, President and CEO of Peregrine. "At the same time, we continue to work to advance our phosphatidylserine (PS)-targeting platform. In order to move toward overall profitability while continuing to generate valuable clinical data, we will focus our future development efforts on small, early stage clinical trials evaluating combinations of bavituximab and immuno-oncology (I-O) agents. This strategy will be supported through our current and future collaborations, which we believe will efficiently generate the clinical data required to identify and pursue the most valuable opportunities for bavituximab."
CONTRACTING MANUFACTURING HIGHLIGHTS:
Avid Bioservices exceeded its full FY 2016 revenue target of $40 million, generating $44 million in contract manufacturing revenue.
The company today announced full FY 2017 revenue guidance for Avid Bioservices of $50-55 million.
Avid currently has a revenue backlog of $56 million under committed contracts from existing clients.
The recently commissioned second manufacturing facility [“Myford”] has completed its initial process validation runs and is ramping up to conduct multiple new process validation runs for three current clients. Process validation is a critical element in preparing a facility to launch commercial manufacturing activities. As such, this milestone moves Peregrine a key step closer to realizing revenue from commercial production from this new manufacturing suite.
Based on significant client demand, Peregrine is in the process of designing a third manufacturing facility focused on clinical manufacturing. This suite will significantly increase the company's manufacturing capacity, with the potential to generate up to $30 million in additional revenue annually. The company has secured a 25,000 square foot location in close proximity to its current campus and expects the new clinical suite to be complete and ready for clinical manufacturing activities by the first half of calendar 2017.
In continued efforts to evolve into a fully integrated manufacturing business capable of efficiently meeting all of its clients' needs, Peregrine is in the process of exploring additional service expansion opportunities.
DRUG DEVELOPMENT HIGHLIGHTS:
The company will pursue a clinical development strategy focused on conducting small, early stage studies of bavituximab in combination with I-O agents. These trials may be conducted as part of ongoing collaborations with AstraZeneca and the National Comprehensive Cancer Network (NCCN). The goal of these trials will be to generate compelling data capable of driving partnering interest. As part of this new strategy, the company has discontinued plans to initiate further Phase II and Phase III trials.
The company continues to evaluate data from the SUNRISE trial in order to collect information that can best inform the ongoing clinical development of bavituximab. As part of these efforts, Peregrine is working closely with AstraZeneca to identify the optimal strategy for the companies' clinical development collaboration focused on combining bavituximab with AstraZeneca's PD-L1 inhibitor, durvalumab. It is expected that the initial trial in the collaboration will be a Phase I study evaluating the treatment combination in a range of solid tumors. The expected timing of initiation of any trial will be determined by the continued collection of data from the SUNRISE trial and finalization of the trial design.
Peregrine's research collaboration with the NCCN, a not-for-profit alliance of 27 of the world's leading cancer centers, is underway. The NCCN is currently accepting proposals from its member institutions and their affiliate community hospitals to conduct clinical trials combining bavituximab with I-O agents for the treatment of a range of cancers. It is expected that between two and five different clinical studies will be conducted as part of this collaboration, potentially providing Peregrine with a wealth of valuable human data to steer future development of bavituximab. While specific timing has not been established, it is expected that the first studies will be initiated in late calendar year 2016 or early 2017.
Peregrine's ongoing preclinical research collaboration with Memorial Sloan Kettering Cancer Center (MSKCC) continues to progress as planned. Researchers at MSKCC are evaluating novel combinations of bavituximab and other relevant I-O therapeutic approaches including checkpoint inhibitors, adoptive T-cell therapy and oncogenic virus, in multiple preclinical cancer models. Initial data from these studies is expected to be presented at scientific conferences later in calendar year 2016.
FINANCIAL STRENGTH SUPPORTING ONGOING ACTIVITIES
Peregrine remains in a strong financial position to continue to execute against its operational strategies for its contract manufacturing and drug developments businesses. As of April 30, 2016, the company had $61 million in cash and cash equivalents.
ABOUT BAVITUXIMAB: A TARGETED INVESTIGATIONAL IMMUNOTHERAPY
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 company focused on continued revenue growth from its contract manufacturing business and developing its novel immuno-oncology products. The company is working to evaluate its lead immunotherapy candidate, bavituximab, in combination with a range of novel immuno-oncology (I-O) agents for the treatment of various cancers. Peregrine's in-house cGMP manufacturing 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. For more information, please visit http://www.peregrineinc.com .
Safe Harbor *snip*
Contacts:
Jay Carlson, Peregrine Pharmaceuticals, Inc. (800) 987-8256 info@peregrineinc.com
Stephanie Diaz (Investors), Vida Strategic Partners 415-675-7401 sdiaz@vidasp.com
Tim Brons (Media), Vida Strategic Partners 415-675-7402 tbrons@vidasp.com
= = = = = = = = = = = = =
AVID BIOSERVICES, Inc. (Peregrine's Mfg. Subsidiary): http://www.avidbio.com
3-9-16: PPHM's Revs & Burns By Qtr Table, FY'07/Q1 thru FY'16/Q3 (q/e 1-31-16): http://tinyurl.com/gom7md5 (since 5-2006: Avid=$154.8mm, Total=$181.4mm, incl.Govt)
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: https://www.youtube.com/watch?v=JqJIH33JY8g
3-7-16/Avid II: Formal Commissioning of Avid's New 40,000sq "Myford" Facility, “single-use/fully disposable” (potentially $40M addl revs) http://tinyurl.com/za2j9mt
12-10-15/Avid II: Avid Expansion into MYFORD Facility now GMP-run ready (potential +$40mm sales) - contemplating further expansion http://tinyurl.com/z35623w
6-17-15: Avid’s John Haney (ex-Genentech/Pfizer) speaking at BIO-INTL’5/Philly http://tinyurl.com/pnlquu3 & http://tinyurl.com/nl4vbgk
...”Designing & Implementing Avid’s New State-of-the-Art Single-Use Facility for Late Ph.3 & Commercial Prod.” - SK: "We've seen tremendous interest for production in the new facility, both from new & existing clients"
12-10-14: Avid to Double Mfg. Capacity (“expanding client roster; potential commercial launch of bavituximab”) http://tinyurl.com/mmc3qgy & http://tinyurl.com/kmdgq8t
3-24-15: Avid Receives CMO Leadership Awards for Its Commitment to Innovation & Reliability http://tinyurl.com/psep47f
= = = = = = =KNOWN UPCOMING 2016:
Jun2-4: ICDS 2016: Translational Implications in Cell Death", Cork Ireland http://tinyurl.com/h2gvyld
...Dr. Rolf Brekken (USA, UTSE, PPHM SAB): ”Blockade of PS & Immune Activation in Cancer” (Chair: Dr. Raymond Birge/Rutgers – see http://tinyurl.com/j3whbx3 )
Jun3-7(PPHM Booth #13153): ASCO 2016, Chicago http://am.asco.org
Jun6-9/Avid/Booth5562: BIO Intl. Convention, SanFran http://convention.bio.org
Jun16-19: WISTAR's Regulatory Myeloid Suppressor Cells Conf., Philadelphia http://tinyurl.com/z4lyawd
SPONSORS: GENERAL: Genentech, J&J(Janssen-Onc); SESSION: Juno, Galera, Reata, Peregrine; DAY: Syndax
CONF. CHAIR: Dmitry Gabrilovich, MD, PhD [PPHM SAB]
...6-19-16/10:45am: Dr. Rolf Brekken [UTSW, PPHM SAB] , ”PS Signaling & Immune Suppression in the Tumor Microenvironment”
Jun19-22 *Delayed till May'17 due to Unfortunate World Events* “ICDS'16 - From Molecules To Diseases”, Istanbul Turkey http://tinyurl.com/h4zjvo4 - ….Rutgers' Dr. Raymond Birge ( http://birgelab.org ) “Phosphatidylserine is a Global Immunosuppressive Signal in Cell Death & Cancer” - see http://tinyurl.com/j3whbx3
~Jul12: FY'16Q4 (y/e 4-30-16) Financials & Conf. Call http://ir.peregrineinc.com/events.cfm
Aug15-18/Avid/Booth#200: CHI's 4th Annual BioProcessing Summit, Boston http://www.bioprocessingsummit.com
Aug31: CHI's 4th Annual Immuno-Oncology Summit, Boston http://tinyurl.com/j35f5pr
...12:15pm: Dr. Bruce Freimark (Dir.PreClinRES), “Tipping the Balance: Overriding PS-Mediated Tumor Immune Suppression to Enhance Immune Checkpoint Therapies”
Oct4-7/Avid/Booth#716: IBC's BioProcess Intl. Conf., Boston http://www.ibclifesciences.com/BPI/overview.xml
Dec11-15/Avid/Booth#209: IBC's Antibody Eng. & Therapeutics 2016”, SanDiego http://www.ibclifesciences.com/AntibodyEng/overview.xml
PPHM SAB'ers Drs. Brekken+Gabrilovich June16-19 WISTAR “Myeloid Suppressors” Conf. in Philadelphia. Peregrine is 1 of 4 Session Sponsors. Dr. Brekken speaking on, “PS Signaling & Immune Suppression in the Tumor Microenvironment”.
Jun16-19 2016: “WISTAR's Regulatory Myeloid Suppressor Cells Conf.”, Philadelphia
“FROM BASIC DISCOVERY TO THERAPEUTIC APPLICATION” http://myeloidsuppressors.com
“This conference will focus on the pathological functions of myeloid-derived suppressor cells, dendritic cells, macrophages and neutrophils, and provide a forum for in-depth discussion of the most pressing issues associated with the biology & clinical application of these cells. The conference will bring together scientists from academia & industry interested in the basic and translational aspects of these cells in cancer and other pathological conditions.”
OVERVIEW: Myeloid cells are comprised of populations of mature terminally differentiated macrophages, dendritic cells and neutrophils, as well as immature myeloid cells including granulocytes, monocytes, and myeloid progenitors. These cells are evolutionarily designed to protect the host from bacteria and viruses by utilizing mechanisms of innate & adaptive immunity. They are also major contributors to tissue remodeling after injuries or resolved inflammation. In cancer, chronic infections, and inflammation, these cells are undergoing extensive changes, which make them immunosuppressive, able to actively promote angiogenesis, tumor cell invasion, and formation of pre-metastatic niches. Recent data demonstrates the association of accumulation of these cells in cancer patients and clinical outcomes of the diseases. With the development of novel immunotherapeutics, it became apparent that regulatory myeloid cells play a major role in limiting therapeutic efficacy of treatment. This conference is focused on pathological functions of myeloid-derived suppressor cells, dendritic cells, macrophages and neutrophils. The specific goals of this meeting are to develop a better understanding of the mechanisms regulating the accumulation of these cells, markers that allow for detection of these cells in cancer patients and patients with chronic infections & inflammation, and approaches to therapeutic targeting of these cells.
SPONSORS: GENERAL: Genentech, J&J(Janssen-Onc); SESSION: Juno, Galera, Reata, Peregrine; DAY: Syndax
CONF. CHAIR: Dmitry Gabrilovich, MD, PhD [PPHM SAB]
Keynote: Robert A. Weinberg, Whitehead Inst. for Biomedical Research, MIT
40 Speakers, including:
Rolf A. Brekken [PPHM SAB], UTSW-MC/Dallas
Dmitry I. Gabrilovich [PPHM SAB], The Wistar Institute, Philadelphia
- - - - - - -
6-19-16/Sun.: SESSION 6 THERAPEUTIC TARGETING OF MYELOID CELLS
9:00am: “IDO, PTEN-Tregs and control of APCs...”, David Munn, Georgia Regents Univ.
9:35am: “Graft-vs-host disease (GvHD)-associated… adoptively transferred MDSCs”, Bruce Blazar, U-Minn.
10:10am: “Combination therapy of anti-PD-1 & CSF-1R inhibitor...”, Rolf Kiessling, Karolinska Inst., Stockholm
10:45am: “Phosphatidylserine Signaling & Immune Suppression in the Tumor Microenvironment”, Dr. Rolf Brekken [PPHM SAB], UTSW-MC/Dallas
- - - - - - -
6-18-16/Sat. 3:45-5:50pm: SESSION 5 - CLINICAL SIGNIFICANCE OF REGULATORY MYELOID CELLS - Sponsored by: Peregrine Pharmaceuticals
= = = = = = = = =
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.”
11-8-14 SITC'14: Ph.2 Correlative Studies data (biopsies B4/After) on 6pts, incl. KOL Dimitry Gabrilovich’s comments: http://tinyurl.com/pchzr6h
12-10-13: With recent scientific insights highlighting bavi’s immunostimulatory moa, these additions to PPHM’s SAB: Dimitry Gabrilovich, Scott Antonia, David Carbone**, Hakan Mellstedt http://tinyurl.com/mw776mk
......**A/o 9-2015, Dr. David Carbone (PPHM SAB/KOL) is President of IASLC https://www.iaslc.org/about-us/board
5-25-16/OncoTarget article, “PS-Targeted Liposome For Enhanced Glioma-Selective Imaging” - Wake Forest's Dawen Zhao & UTSW's Liang Zhang...
5-25-16/OncoTarget(Imaging): “Phosphatidylserine-Targeted [PGN635=FullyHuman Bavi] Liposome For Enhanced Glioma-Selective Imaging”
OncoTarget Journal #9584 - Rec.2-14-16, Acc.4-28-16, Pub.5-25-16
Liang Zhang 1, Amyn A. Habib 2, Dawen Zhao(Wake Forest Univ.) 3,4
1 Dept of Radiology, UTSW-MC/Dallas
2 Dept of Neurology & Neurotherapeutics, UTSW-MC/Dallas
3 Dept of Biomedical Engineering, Wake Forest School of Medicine, Winston Salem, NC
4 Dept of Cancer Biology, Wake Forest School of Medicine, Winston Salem, NC
FULL ARTICLE: http://www.impactjournals.com/oncotarget/index.php?journal=oncotarget&page=article&op=view&path[]=9584&path[]=30014
ABSTRACT:
Phosphatidylserine (PS), which is normally intracellular, becomes exposed on the outer surface of viable endothelial cells (ECs) of tumor vasculature. Utilizing a PS-targeting antibody, we have recently established a PS-targeted liposomal (PS-L) nanoplatform that has demonstrated to be highly tumor-selective. Because of the vascular lumen-exposed PS that is immediately accessible without a need to penetrate the intact blood brain barrier (BBB), we hypothesize that the systemically administered PS-L binds specifically to tumor vascular ECs, becomes subsequently internalized into the cells and then enables its cargos to be efficiently delivered to glioma parenchyma. To test this, we exploited the dual MRI/optical imaging contrast agents-loaded PS-L and injected it intravenously into mice bearing intracranial U87 glioma. At 24h, both in vivo optical imaging and MRI depicted enhanced tumor contrast, distinct from the surrounding normal brain. Intriguingly, longitudinal MRI revealed temporal and spatial intratumoral distribution of the PS-L by following MRI contrast changes, which appeared punctate in tumor periphery at an earlier time point (4h), but became clustering and disseminated throughout the tumor at 24h post injection. Importantly, glioma-targeting specificity of the PS-L was antigen specific, since a control probe of irrelevant specificity showed minimal accumulation in the glioma. Together, these results indicate that the PS-L nanoplatform enables the enhanced, glioma-targeted delivery of imaging contrast agents by crossing the tumor BBB efficiently, which may also serve as a useful nanoplatform for anti-glioma drugs.
CONCLUSIONS:
Given the fact that many GBM blood vessels remain impermeable, the discovery and development of a drug delivery system that enables penetration specifically across the tumor BBB will be critical for effective glioma-targeted diagnosis and treatment. In the present study, we demonstrate that the PS-targeted liposomal (PS-L) nanoplatform allows sufficient delivery of the dual imaging contrast agents across the tumor BBB to the glioma parenchyma, which was visualized by in vivo MRI and optical imaging. The temporal and spatial changes in intratumoral MRI contrast may correlate well with the initial binding of the PS-L to tumor vascular ECs and disseminating across the tumor tissues at the later stage. The study thus provides proof of principle for the further development of glioma-targeted nanodelivery of therapeutic agents or theranostic agents for both glioma imaging and treatment.
ACKNOWLEDGMENTS: We would like to pay tribute to the late Dr. Philip Thorpe for his pioneered research on phosphatidylserine and development of a series of PS-targeting antibodies. We thank Peregrine Pharmaceuticals Inc., Tustin CA, for the provision of PGN635 [PGN635=FullyHuman Bavi] antibody.
GRANT SUPPORT: GBM research has been supported in part by NIH R01 CA194578 (DZ) and a grant from the Dept. of Veteran’s Affairs (to AH). Imaging was conducted by NIH P41-RR02584, and DOE grant DE-FG02-05CH11280.
Dr. Dawen Zhao: http://www.wakehealth.edu/News-Releases/2015/Zhao_Named_Wells_Fargo_Faculty_Scholar.htm
5-20-16: FBR's Thomas Yip Comments on Peregrine ahead of ASCO'16...
Yip noted, “While there will be no formal presentation at ASCO, we think a potential update at the conference would be crucial to bavituximab’s future development in combination with cancer immunotherapies, and could inform us the potential of a bavituximab-durvalumab combination.”
“We would look for an update on the progress of PPHM 1501, a Phase II open-label trial of the drug combination for the treatment of metastatic non-small cell lung cancer (NSCLC). Patients are randomized in a 1:1:1 ratio to receive either: 1) 10 mg/kg durvalumab mono-therapy every two weeks, 2) 3 mg/kg bavituximab weekly plus 10 mg/kg durvalumab every two weeks, or 3) 3 mg/kg bavituximab plus 10 mg/kg durvalumab both every two weeks. PPHM 1501 is Peregrine’s first global trial evaluating bavituximab in combination with a cancer immunotherapy, with an enrollment target of about 198 patients,” the analyst added.
http://www.smarteranalyst.com/2016/05/20/fbr-capital-reiterates-outperform-peregrine-pharmaceuticals-pphm-ahead-asco-2016-annual-meeting/
Dr.Bruce.Freimark(PPHM's Dir./Preclin) speaks 8-31-16 at a CHI I-O Conference, describing how “PS targeting antibodies enhance the anti-tumor activity & survival of checkpoint antibodies in preclin. tumor models”...
Aug29-Sept2: “CHI's 4th Annual Immuno-Oncology Summit”, Boston http://www.immuno-oncologysummit.com
“As our understanding of tumor immunology has advanced, immuno-oncology has made unprecedented progress in improving the outcomes for cancer patients. Still, with the field in its infancy, the full curative potential of IO has yet to be realized. CHI’s 4th Annual Immuno-Oncology Summit has been designed to support a coordinated effort by industry players to bring commercial immunotherapies & immunotherapy combinations through clinical development and into the market.”
CHI = Cambridge Healthtech Institute http://www.chicorporate.com - “the preeminent life science network for leading researchers & business experts from top pharmaceutical, biotech, and academic organizations.”
SUB-CONF(1 of 9; 2day): PRECLINICAL & TRANSLATIONAL IMMUNO-ONCOLOGY - “Predictive Preclinical Models for Cancer Immunotherapy”
http://www.immuno-oncologysummit.com/Preclinical-Immuno-Oncology
8-31-16 Session: NOVEL IN VITRO MODELS FOR IMMUNOTHERAPY DISCOVERY
Chairperson: Oliver Ghobrial (AbbVie)
12:15pm Bruce Freimark, PhD, Res.Dir., Preclinical Oncology, Peregrine Pharm.
“Tipping the Balance: Overriding Phosphatidylserine-Mediated Tumor Immune Suppression to Enhance Immune Checkpoint Therapies”
OVERVIEW: Phosphatidylserine (PS) exposure in tumors induces non-inflammatory signals which contribute to an immunosuppressive environment. Antibody blockade of PS activates immune responses by promoting M1 macrophages, maturation of dendritic cells and inducing adaptive T-cell responses. PS targeting antibodies enhance the anti-tumor activity and survival of checkpoint antibodies in preclinical tumor models by increasing activated cytotoxic T-cell infiltrates and immune stimulatory mediators.
= = = = = = = =KNOWN UPCOMING:
May26: UTSW-MC Hamon Center Lab Seminar, Dallas http://tinyurl.com/ztsyl2w
...9am: Dr. Xianming Huang(Rolf Brekken Lab), "PS-Targeting Antibody Synergizes with Immune Checkpoint Blockade for Cancer Immunotherapy"
Jun2-4: ICDS 2016: Translational Implications in Cell Death", Cork Ireland http://tinyurl.com/h2gvyld
...Dr. Rolf Brekken (USA, UTSE, PPHM SAB): “Blockade of PS & Immune Activation in Cancer” (Chair: Dr. Raymond Birge/Rutgers – see http://tinyurl.com/j3whbx3 )
Jun3-7(PPHM Booth #13153): ASCO 2016, Chicago http://am.asco.org (Abstracts released 5-18-16 5pm: http://meetinglibrary.asco.org )
Jun6-9/Avid/Booth5562: BIO Intl. Convention, SanFran http://convention.bio.org
Jun16-19: WISTAR's Regulatory Myeloid Suppressor Cells Conf., Philadelphia http://tinyurl.com/hwrogdk
...SPONSORS: GENERAL: Peregrine, Genentech, J&J(Janssen-Onc); SESSION: Juno, Galera, Reata; DAY: Syndax
...Speaker: Dr. Rolf Brekken [PPHM SAB] (Conf.Chair: Dmitry Gabrilovich, The Wistar Institute, PPHM SAB)
Jun19-22 *Delayed till May'17 due to Unfortunate World Events* “ICDS'16 - From Molecules To Diseases”, Istanbul Turkey http://tinyurl.com/h4zjvo4 - ….Rutgers' Dr. Raymond Birge ( http://birgelab.org ) “Phosphatidylserine is a Global Immunosuppressive Signal in Cell Death & Cancer” - see http://tinyurl.com/j3whbx3
~Jul12: FY'16Q4 (y/e 4-30-16) Financials & Conf. Call http://ir.peregrineinc.com/events.cfm
Aug31: CHI's 4th Annual Immuno-Oncology Summit, Boston http://tinyurl.com/j35f5pr
...12:15pm: Dr. Bruce Freimark (Dir.PreClinRES), “Tipping the Balance: Overriding PS-Mediated Tumor Immune Suppression to Enhance Immune Checkpoint Therapies”
.
I forgot this 4-2016/Cancer-Immunology-Res. article which UC/Irvine's Dr.CW.Hughes co-authored with UTSW & Peregrine. This one on how combining PS-Targeting/Bavi with anti-CTLA4 & anti-PD1 enhances overall effectiveness in MELANOMA...
4-4-16: “Antibody-Mediated Phosphatidylserine Blockade Enhances the Antitumor Responses to CTLA-4 & PD-1 Antibodies in Melanoma”
Cancer Research Institute Journal (AACR) – Rec.10-2-15, Rev.12-29-15, Acc.1-20-16, PubOnline=4-4-16
http://cancerimmunolres.aacrjournals.org/content/early/2016/04/02/2326-6066.CIR-15-0250.abstract
FULL(32pgs): http://cancerimmunolres.aacrjournals.org/content/early/2016/04/02/2326-6066.CIR-15-0250.full.pdf
Bruce Freimark 1, Jian Gong 1, Dan Ye 2, Michael J. Gray 3, Van Nguyen 1, Shen Yin 1, Michaela M.S. Hatch(Hughes Lab) 4, Christopher C W Hughes(UC-Irvine, PPHM SAB) 4, Alan J Schroit(PPHM SAB) 5, Jeff T Hutchins 1, Rolf A Brekken(PPHM SAB) 2, Xianming Huang 2
1 Preclinical Research, Peregrine Pharmaceuticals, Inc.
2 Hamon Ctr for Therapeutic Oncology Res., Depts of Surgery/Pharmacology, UTSW-MC/Dallas
3 Preclin. Research, Peregrine Pharmaceuticals
4 Molecular Biology & Biochemistry, Univ. of California, Irvine
5 Simmons Cancer Center, UTSW/Dallas
ABSTRACT
In tumor bearing animals, the membrane phospholipid phosphatidylserine (PS) suppresses immune responses, suggesting that PS signaling could counteract the antitumor effect of antibody-driven immune checkpoint blockade. Here we show that treating melanoma-bearing mice with a PS-targeting antibody enhances the antitumor activity of downstream checkpoint inhibition. Combining PS-targeting antibodies with CTLA-4 or PD-1 blockade resulted in significantly greater inhibition of tumor growth than did single agent therapy. Moreover, combination therapy enhanced CD4+ and CD8+ tumor-infiltrating lymphocyte numbers; elevated the fraction of cells expressing the pro-inflammatory cytokines IL2, IFNy, and TNFa; and increased the ratio of CD8 T cells to myeloid-derived suppressor cells and regulatory T cells in tumors. Similar changes in immune cell profiles were observed in splenocytes. Taken together, these data show that antibody-mediated PS blockade enhances the antitumor efficacy of immune checkpoint inhibition.
. . .
IN SUMMARY(Pg.17): In summary, we have shown that PS-targeting antibodies improve the efficacy of anti-CTLA-4 or anti-PD-1 therapy in murine models of melanoma, suggesting that these combinations have the potential to improve outcome in patients with advanced stage melanoma. Bavituximab, a chimeric PS-targeting antibody, is currently being evaluated in late-stage clinical trials for the treatment of cancer patients with solid tumors (46,54) and strong antitumor activity has been demonstrated in melanoma clinical trials using checkpoint inhibitor antibodies targeting CTLA-4 (10), PD-1 (12,13), and PD-L1 (55). It is increasingly apparent that successful immunotherapy requires tumor cell killing, induction of pro-inflammatory immune responses and concomitant reduction of immunosuppressive signals leading to increased tumor infiltration by activated T cells. Based on the distinct mechanism of action and multiple points of blockade, PS-targeting antibodies such as bavituximab may enhance the anti-tumor responses of immune checkpoint inhibitors by further blocking suppressive signals in the tumor microenvironment.
= = = = = = = = = = = = = = = = = = http://tinyurl.com/jljk7jq
5-13-16: Peregrine's work with Univ.Cal/Irvine/CW-Hughes goes back many years, lead by Dr. Christopher C. W. Hughes, PhD, Chair, Molecular Biology & Biochemistry
School of Biological Sciences: http://www.faculty.uci.edu/profile.cfm?faculty_id=2498 . He's on Peregrine's SAB ( http://www.peregrineinc.com/about-us/medical-and-scientific-advisors.html ), has conducted pre-clin. research with Peregrine's Anti-PS/Bavi compounds for many years, and has co-authored several articles with Peregrine & UTSW scientists.
Peregrine's work with Univ.Cal/Irvine goes back many years, lead by Dr. Christopher C. W. Hughes, PhD, Chair, Molecular Biology & Biochemistry
School of Biological Sciences: http://www.faculty.uci.edu/profile.cfm?faculty_id=2498 . He's on Peregrine's SAB ( http://www.peregrineinc.com/about-us/medical-and-scientific-advisors.html ), has conducted pre-clin. research with Peregrine's Anti-PS/Bavi compounds for many years, and has co-authored several articles with Peregrine & UTSW scientists.
A good example is the latest Bavi/I-O Article published in BREAST CANCER RES. on 5-11-16, which Dr. CW Hughes co-authored with UC/Irvine's Dr. Michaela Hatch (member of Dr. Hughe's Lab) and Peregrine scientists:
5-11-16/Breast Cancer Research: “Phosphatidylserine-targeting Antibodies Augment the Anti-Tumorigenic Activity of Anti-PD-1 Therapy by Enhancing Immune Activation & Downregulating Pro-Oncogenic Factors Induced by T-Cell Checkpoint Inhibition in Murine Triple-NegativeBreast Cancers”
http://breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-016-0708-2
Michael J. Gray, Jian Gong, Michaela M. S. Hatch, Van Nguyen, Christopher C. W. Hughes, Jeff T. Hutchins, Bruce D. Freimark
Rec. 1-27-16, Acc. 4-22-16, Pub. 5-11-16 - see: http://tinyurl.com/zxu882y
BACKGROUND: The purpose of this study was to investigate the potential of antibody-directed immunotherapy targeting the aminophospholipid phosphatidylserine, which promotes immunosuppression when exposed in the tumor microenvironment, alone and in combination with antibody treatment towards the T-cell checkpoint inhibitor PD-1 in breast carcinomas, including triple-negative breast cancers. . . .
CONCLUSIONS(Abstract): Our data suggest that antibody therapy targeting phosphatidylserine-associated immunosuppression, which has activity as a single agent, can significantly enhance immunotherapies targeting the PD-1 pathway in murine breast neoplasms, including triple-negative breast cancers.
CONCLUSIONS(Article): In summary, our observations demonstrate that including PS-targeting antibodies such as bavituximab can enhance the anti-tumor activity of anti-PD-1/PD-L1 treatments, not only by increasing TIL responses but also by inhibiting cytokines stimulated by single-agent anti-PD-1 therapy that serve to suppress the immune response and promote tumor progression.
COMPETING INTERESTS: Christopher C. W. Hughes is Professor & Chair, Dept of Molecular Biology & Biochemistry, Univ. of California, Irvine, and is a consultant to Peregrine Pharmaceuticals. Michaela M. S. Hatch is a research scientist working in the lab of CCWH. All other authors are employees of Peregrine Pharmaceuticals.
FULL ARTICLE: http://breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-016-0708-2
= = = = = = = = = = =ANOTHER GOOD EXAMPLE (PPHM, UC-Irvine/CW-Hughes, UTSW):
AACR’15 (3 Abstracts, 2 PR’s): Bavi Clinical TransData/Lung & PreClinData/Melanoma/Breast – Moffitt/S.Antonia, UTSW, Univ. of Calif/Irvine(Chris Hughes), and Peregrine. See: http://tinyurl.com/n7e7r7p
AACR'15 POSTER #252 PDF: http://www.peregrineinc.com/images/stories/pdfs/aacr_2015_melanoma.pdf
5-11-16/BC-Res. article, Freimark-et-al, “PS-Targeting/Anti-PD1/Triple-MBC” - our observations demonstrate that including PS-targeting antibodies such as bavituximab can enhance the anti-tumor activity of anti-PD-1/PD-L1 treatments, not only by increasing TIL responses but also by inhibiting cytokines stimulated by single-agent anti-PD-1 therapy that serve to suppress the immune response & promote tumor progression.
5-11-16/Breast Cancer Research: “Phosphatidylserine-targeting Antibodies Augment the Anti-Tumorigenic Activity of Anti-PD-1 Therapy by Enhancing Immune Activation & Downregulating Pro-Oncogenic Factors Induced by T-Cell Checkpoint Inhibition in Murine Triple-Negative Breast Cancers”
http://breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-016-0708-2
Michael J. Gray, Jian Gong, Michaela M. S. Hatch, Van Nguyen, Christopher C. W. Hughes, Jeff T. Hutchins, Bruce D. Freimark
Rec. 1-27-16, Acc. 4-22-16, Pub. 5-11-16
BACKGROUND: The purpose of this study was to investigate the potential of antibody-directed immunotherapy targeting the aminophospholipid phosphatidylserine, which promotes immunosuppression when exposed in the tumor microenvironment, alone and in combination with antibody treatment towards the T-cell checkpoint inhibitor PD-1 in breast carcinomas, including triple-negative breast cancers. . . .
CONCLUSIONS(Abstract): Our data suggest that antibody therapy targeting phosphatidylserine-associated immunosuppression, which has activity as a single agent, can significantly enhance immunotherapies targeting the PD-1 pathway in murine breast neoplasms, including triple-negative breast cancers.
CONCLUSIONS(Article): In summary, our observations demonstrate that including PS-targeting antibodies such as bavituximab can enhance the anti-tumor activity of anti-PD-1/PD-L1 treatments, not only by increasing TIL responses but also by inhibiting cytokines stimulated by single-agent anti-PD-1 therapy that serve to suppress the immune response and promote tumor progression.
COMPETING INTERESTS: Christopher C. W. Hughes is Professor & Chair, Dept of Molecular Biology & Biochemistry, Univ. of California, Irvine, and is a consultant to Peregrine Pharmaceuticals. Michaela M. S. Hatch is a research scientist working in the lab of CCWH. All other authors are employees of Peregrine Pharmaceuticals.
FULL ARTICLE: http://breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-016-0708-2
= = = = = = = = = = =RECALL: http://tinyurl.com/jyox458
4-20-16/AACR'16 & 4-4-16/Cancer-Immunology-Res.(AACR) article, both describing preclin. data showing that Bavi combination I-O treatment (w/anti-PD-1 & anti-CTLA-4) “induces a shift in the tumor microenvironment from immunosuppressive to immune active” in Triple- Breast Cancer & Melanoma. 4-20-16 PR references a “planned clinical trial of bavituximab in combination with AstraZeneca's durvalumab under a clinical collaboration”. The AACR'16 poster #5116 (PPHM/U.Cal-Irvine) PDF now on Peregrine's website: http://www.peregrineinc.com/images/stories/pdfs/aacr-2016-gray.pdf
4-20-16/AACR'16 PR: Preclinical Data Presented at American Association for Cancer Research (AACR) Annual Meeting Demonstrate Enhanced Therapeutic Benefit of Combining a PS-Targeting Antibody With Anti-PD-1 Therapy in Models of Triple Negative Breast Cancer (TNBC)
* Statistically Significant Improvement in Overall Survival for Combination as Compared to Anti-PD-1 Therapy Alone in TNBC Models; Combination Also Protects Against Re-Challenge With TNBC Tumor Cells
* Novel Genetic Analysis Technology Further Validates Immune Modulating Mechanism of Bavituximab and Anti-PD-1 Combination; Supports Clinical Evaluation of Bavituximab and I-O Agent Combinations
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=965932
TUSTIN, April 20, 2016: Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM, PPHMP), a biopharmaceutical company focused on developing therapeutics to stimulate the body's immune system to fight cancer, today announced the presentation of preclinical study data demonstrating enhanced anti-tumor activity and immune activation for a combination of the preclinical bavituximab equivalent (ch1N11) and anti-PD-1 therapy in models of breast cancer including triple negative breast cancer (TNBC). Additionally, new analysis conducted using the nCounter ® PanCancer Immune Profiling Panel from NanoString Technologies ® further validated previously reported findings showing that the combination treatment induced a shift in the tumor microenvironment from immunosuppressive to immune active. This was evidenced by a distinct change in immune cell phenotypes, as well as an increase in immune activating cytokines and decrease in immunosuppressive cytokines. These study results, which were presented at the 2016 American Association for Cancer Research (AACR 2016) Annual Meeting, provide further support for Peregrine's strategy of evaluating bavituximab in combination with a range of novel immuno-oncology (I-O) agents for the treatment of various cancers.
"These presented study results, particularly the significant increase in overall survival and immunity to tumor re-challenge seen with the treatment combination as compared to anti-PD-1 therapy alone, continue to strengthen our collection of translational and preclinical data supporting the potential for bavituximab to enhance the therapeutic impact of I-O agents in the treatment of cancer. In doing so, these data provide further rationale for our clinical strategy focused on studying bavituximab in combination with I-O agents targeting the PD-1/PD-L1 pathway in a range of cancers," stated Jeff T. Hutchins, Ph.D., Peregrine's VP, Preclinical Research. "With a wealth of supportive research in hand, we look forward to the continued advancement of our clinical collaborations with AstraZeneca, the National Comprehensive Cancer Network [NCCN] and Memorial Sloan Kettering Cancer Center, to further evaluate the therapeutic potential of bavituximab with novel I-O agent combinations."
Bavituximab is an investigational immunotherapy designed to assist the body's immune system by targeting and modulating the activity of phosphatidylserine (PS), a highly immune-suppressive signaling molecule expressed broadly on the surface of cells in the tumor microenvironment. Peregrine's PS signaling pathway inhibitor candidates, including bavituximab, reverse the immunosuppressive environment that many tumors establish in order to proliferate, while also activating immune cells that target and fight cancer. The preclinical equivalent of bavituximab, ch1N11, is used in animal model studies as a guide for clinical development.
As part of the study that was presented at AACR [Poster #5116 PPHM/Friemark, U.Cal-Irvine/CW-Hughes http://www.peregrineinc.com/images/stories/pdfs/aacr-2016-gray.pdf ], researchers evaluated the combination of ch1N11 and anti-PD-1 therapy versus anti-PD-1 stand-alone therapy in two well-characterized murine models of TNBC (EMT-6 and E0771). Study data showed that the combination therapy significantly enhanced overall survival (p=0.0155) and was capable of mediating complete tumor regressions in a greater number of subjects compared to single agent treatments (60% vs. 20%). Data also demonstrated that animals receiving combination treatment had significant increases in tumor associated indicators of immune system activation, including CD45+, CD8+ and CD3+ T-cells. Importantly, the combination treatment led to a prolonged anti-tumor immune response which protected the animals that achieved a complete tumor regression against a re-challenge with the same E0771 TNBC model tumor cells. This sustained anti-tumor response demonstrates the ability of the combination treatment to trigger immune system memory and support adaptive immune responses against reemerging disease in this TNBC model. All study animals experienced no signs of adverse effects or weight loss following repeated doses of all therapeutic agents.
About Bavituximab: A Targeted Investigational Immunotherapy
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 developing therapeutics to stimulate the body's immune system to fight cancer. The company is focused on evaluating its lead immunotherapy candidate, bavituximab, in combination with a range of novel immuno-oncology (I-O) agents for the treatment of various cancers. One specific component of this I-O combination strategy includes a planned clinical trial of bavituximab in combination with durvalumab, AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor, under a clinical collaboration.
In addition to its drug development programs, Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com ), which provides development and biomanufacturing services for both Peregrine and third-party customers. For more information, please visit http://www.peregrineinc.com .
Safe Harbor *snip*
Jay Carlson, Peregrine Pharmaceuticals, Inc., 800-987-8256 info@peregrineinc.com
Stephanie Diaz (Investors), Vida Strategic Partners, 415-675-7401 sdiaz@vidasp.com
Tim Brons (Media), Vida Strategic Partners, 415-675-7402 tbrons@vidasp.com
Apr17-20 2016: AACR 2016, New Orleans
http://www.aacr.org/Meetings/Pages/MeetingDetail.aspx?EventItemID=63
Abstracts: http://www.aacr.org/Meetings/Pages/MeetingDetail.aspx?EventItemID=63&DetailItemID=363
4-20-16/Wed. 7:30-11am, Session: IMMUNOMODULATION & IMMUNOTHERAPY
#5116: “Phosphatidylserine-Targeting Antibodies Augment Anti-Tumor Activity of PD-1 Antibodies and Alter Immuno-Profiles in Murine Triple Negative Breast Cancers”
Michael J. Gray 1, Jian Gong 1, Ryan N. Parks 1, Michaela M.S. Hatch 2, Van Nguyen 1, Christopher C.W. Hughes 2, Jeff T. Hutchins 1, Bruce D. Freimark 1
1=Peregrine Pharmaceuticals; 2=Univ. of Calif./Irvine
ABSTRACT: Current treatments for triple negative breast cancers rely primarily upon surgical intervention and chemotherapy. Unfortunately, chemotherapies have the propensity to help establish an immunosuppressive condition in part though exposure of phosphatidylserine (PS) in the tumor microenvironment. We demonstrate that treatment of the murine triple negative breast cancer E0771 using a PS-targeting antibody inhibits in vivo growth, and significantly enhances the anti-tumor activity of antibodies directed to the checkpoint inhibitor PD-1. Combinational treatment by antibodies targeting PS & PD-1 increased the number of tumor infiltrating lymphocytes (TILs) to a greater extent than observed with single-arm therapies. Furthermore, combination of PS & PD-1 targeting antibodies provides a distinct survival advantage over treatment by either agent alone, which correlates with an increase in complete tumor regression and the onset of a durable immune mediated response capable of rejecting a secondary challenge by the same tumor. Finally, immune-profiling analysis of tumor RNA using Nanostring revealed that the combination antibody therapy enhanced immune regulatory pathways including MHC class I/II expression, antigen processing and presentation, and leukocyte and macrophage functions. Combined, our data suggest that in triple negative breast cancers antibody therapy blocking PS-associated immunosuppression may further enhance immunotherapies directed at immune checkpoint inhibitors, including those targeting the PDL-1/PD-1 axis.
Poster #5116 PDF: http://www.peregrineinc.com/images/stories/pdfs/aacr-2016-gray.pdf
- - - - - - - - -
Peregrine Exhibiting at Booth #2318 (across from MDAnderson #2312)
http://www.aacr.org/Documents/16AM_Exhibits_ListasofApr4.pdf (see rt.side bottom)
= = = = = = = = = = = = = = = = = = = = = = =
4-4-16/Cancer-Immunology-Res.(AACR) article, “PS Blockade Enhances Antitumor Responses to CTLA-4 & PD-1 Antibodies in Melanoma” - Xianming Huang(UTSW/Brekken Lab), Bruce Freimark, Rolf Brekken(UTSW), 9 others…
4-4-16: “Antibody-Mediated Phosphatidylserine Blockade Enhances the Antitumor Responses to CTLA-4 & PD-1 Antibodies in Melanoma”
Cancer Research Institute Journal (AACR) – Rec.10-2-15, Rev.12-29-15, Acc.1-20-16, PubOnline=4-4-16
http://cancerimmunolres.aacrjournals.org/content/early/2016/04/02/2326-6066.CIR-15-0250.abstract
FULL(32pgs): http://cancerimmunolres.aacrjournals.org/content/early/2016/04/02/2326-6066.CIR-15-0250.full.pdf
Bruce D Freimark 1, Jian Gong 1, Dan Ye 2, Michael J. Gray 3, Van Nguyen 1, Shen Yin 1, Michaela M.S. Hatch 4, Christopher C W Hughes(PPHM SAB) 4, Alan J Schroit(PPHM SAB) 5, Jeff T Hutchins 1, Rolf A Brekken(PPHM SAB) 2, Xianming Huang 2
1 Preclinical Research, Peregrine Pharmaceuticals, Inc.
2 Hamon Ctr for Therapeutic Oncology Res., Depts of Surgery/Pharmacology, UTSW-MC/Dallas
3 Preclinical Research, Peregrine Pharmaceuticals
4 Molecular Biology & Biochemistry, Univ. of California, Irvine
5 Simmons Cancer Center, UTSW/Dallas
ABSTRACT
In tumor bearing animals, the membrane phospholipid phosphatidylserine (PS) suppresses immune responses, suggesting that PS signaling could counteract the antitumor effect of antibody-driven immune checkpoint blockade. Here we show that treating melanoma-bearing mice with a PS-targeting antibody enhances the antitumor activity of downstream checkpoint inhibition. Combining PS-targeting antibodies with CTLA-4 or PD-1 blockade resulted in significantly greater inhibition of tumor growth than did single agent therapy. Moreover, combination therapy enhanced CD4+ and CD8+ tumor-infiltrating lymphocyte numbers; elevated the fraction of cells expressing the pro-inflammatory cytokines IL2, IFNy, and TNFa; and increased the ratio of CD8 T cells to myeloid-derived suppressor cells and regulatory T cells in tumors. Similar changes in immune cell profiles were observed in splenocytes. Taken together, these data show that antibody-mediated PS blockade enhances the antitumor efficacy of immune checkpoint inhibition.
. . .
IN SUMMARY(Pg.17): In summary, we have shown that PS-targeting antibodies improve the efficacy of anti-CTLA-4 or anti-PD-1 therapy in murine models of melanoma, suggesting that these combinations have the potential to improve outcome in patients with advanced stage melanoma. Bavituximab, a chimeric PS-targeting antibody, is currently being evaluated in late-stage clinical trials for the treatment of cancer patients with solid tumors (46,54) and strong antitumor activity has been demonstrated in melanoma clinical trials using checkpoint inhibitor antibodies targeting CTLA-4 (10), PD-1 (12,13), and PD-L1 (55). It is increasingly apparent that successful immunotherapy requires tumor cell killing, induction of pro-inflammatory immune responses and concomitant reduction of immunosuppressive signals leading to increased tumor infiltration by activated T cells. Based on the distinct mechanism of action and multiple points of blockade, PS-targeting antibodies such as bavituximab may enhance the anti-tumor responses of immune checkpoint inhibitors by further blocking suppressive signals in the tumor microenvironment.
= = = = = = = = = = = = = = = = = = = = =
BAVI MOA 1-18-16: CEO Steve King explains PPHM's direct PS-Targeting advantage vs. the “individual-receptors” PS-binding approach of others like: Axl Mer TIM-3 RAGE Tyro3 GAS6 CD300a BAI1 MFG-E8 etc. http://tinyurl.com/h2h87mc
2-2016: Rutgers' Dr. Raymond Birge's relationship with Peregrine & UTSW's Dr. Rolf Brekken and his 2-26-16 article, ”Phosphatidylserine is a Global Immunosuppressive Signal in Efferocytosis, Infectious Disease, and Cancer” http://tinyurl.com/z5d9qt9
11-9-15 SITC'15: New Bavi+Checkpoint Inhibitors preclin. data (UTSW/DUKE's Herbert K. Lyerly) http://tinyurl.com/pbof95w
...Also, collab. with Dr. Bernard Fox (Immunotherapist/Earle A. Chiles Res.Inst.) on new Immuno-Profiling Clinical Test (Opal 6-plex quantitative IF Assay), PPHM roundtable with Raymond Birge (Rutgers), Douglas Graham (Emory), Dmitry Gabrilovich (Wistar), Rolf Brekken (UTSW), Maria Karasarides (AstraZeneca) - ”Combining Bavi w/anti-PD-1 significantly enhanced O/S… significant incr. CD45+, CD8+ and CD3+ T-cells… led a prolonged anti-tumor immune response which protected the animals against a re-challenge w/same tumor.”
BAVI MOA 8-26-15: Jeff Hutchins(VP/PreClin-Res) ImVacS’15 Talk – 29pg. Slideshow http://tinyurl.com/qz64pzg
…“Expansion & Activation of T Cells via the Targeting of the Immunosuppressive Ligand PS: Combination Strategy with Conventional, Targeted, and Checkpoint Inhibitor Therapy”
5-31-15: ASCO’15 Roundtable (webcast), “Raising the Immuno-Oncology Bar” - 7 panel members, incl. 3 Sloan Kettering researchers http://tinyurl.com/qxu4w2x
BAVI MOA 3-25-15: PPHM/VP Dr. Jeff Hutchins’ presentation at "Immune Checkpoint Inhibitors Conf.", Boston - PDF(34 Slides): http://tinyurl.com/ooxkhq7
BAVI MOA 2-9-15: PPHM's Dr. Bruce Freimark’s presentation at KEYSTONE "Tumor Immunology Meeting", Banff/CN – PR & Slides: http://tinyurl.com/q6cx4w6
BAVI MOA 12-12-14 San Antomio Breast Cancer Symposium, Dr. Bruce Freimark, Bavi+anti-PD-1 vs. Breast Cancer http://tinyurl.com/p5ng6vs
Loofman, my friend - re: your poll => YES.
I still have confidence in Peregrine's management and this investment for the future?
4. YES: CJGADDY
PS: Not normally up at this time! I heard my 'pute awakening itself & making racket - for some reason it decided to do a Windows Update at 3am. ...Shutting it down and going back to bed!
Website Pipeline/Bavi-Oncology page completely revamped…
BAVITUXIMAB ONCOLOGY
* About Bavituximab: An Experimental Immuno-Onology Candidate
* Bavituximab in Combination Therapy
* AstraZeneca (AZ) Collaboration
* National Comprehensive Cancer Network (NCCN) Collaboration
* Investigator Sponsored Trials (ISTs)
* Sunrise Phase III Trial of Bavituximab in 2nd-Line NSCLC
* Future Perspectives
* Bavituximab's Historical Data
http://www.peregrineinc.com/pipeline/bavituximab-oncology.html
Dr.Rolf.Brekken (UTSW/PPHM-SAB) speaking May11 in Norway on “PS Signaling & Immune Suppression in the Tumor Microenvironment”. He's also speaking June2-4 at ICDS'16 in Ireland, and June16-19 at a WISTAR Conf. (Conf.Chair: Dmitry Gabrilovich) in Philly…
= = = = = = = = = = = = = = =KNOWN UPCOMING:
May10-11: Center for Cancer Biomarkers' (CCBIO) 4th Annual Symposium, Bergen, Norway http://tinyurl.com/zej245v
...May11 9:30-10am, Dr. Rolf Brekken (UTSW, PPHM SAB), “PS Signaling & Immune Suppression in the Tumor Microenvironment”
June2-4: ICDS 2016: Translational Implications in Cell Death", Cork Ireland http://tinyurl.com/h2gvyld
...Dr. Rolf Brekken (USA, UTSE, PPHM SAB): “Blockade of PS & Immune Activation in Cancer” (Chair: Dr. Raymond Birge/Rutgers – see http://tinyurl.com/j3whbx3 )
Jun3-7(PPHM Booth #13153): ASCO 2016, Chicago http://am.asco.org (Abstracts released 5-18-16 5pm: http://meetinglibrary.asco.org )
Jun6-9/Avid/Booth5562: BIO Intl. Convention, SanFran http://convention.bio.org
Jun16-19: WISTAR's Regulatory Myeloid Suppressor Cells Conf., Philadelphia http://tinyurl.com/hwrogdk
...SPONSORS: GENERAL(3): Peregrine, Genentech, J&J(Janssen-Onc); SESSION(3): Juno, Galera, Reata; DAY: Syndax
...Speaker: Dr. Rolf Brekken [PPHM SAB] (Conf.Chair: Dmitry Gabrilovich, The Wistar Institute, PPHM SAB)
~Jul12: FY'16Q4 (y/e 4-30-16) Financials & Conf. Call http://ir.peregrineinc.com/events.cfm
Avid doesn't have “just one customer”, Vaness…
3-9-16/S.King: “Avid definitely has new clients that have come onboard...” - and that's ClientS plural… Q4/FY16(q/e 4-30-16) Avid revs guidance now min. $14.5mm...
3-9-16/CC Q&A: George Zavoico: ”Re: Avid, have you increased the number of clients you are actually working with now or will be working with?”
Steve King: “Yes, we definitely have new clients that have come onboard, and that’s what’s helping to drive some of the work we are seeing over in the Myford facility, the nice backlog in business for now building up over there. That’s been great, because when you build a facility, you're never quite sure what the response was going to be, but it’s been pretty overwhelming right now, which is good.” http://tinyurl.com/gom7md5
- - - - - - - - - - - -
3-9-16/Qtly-PR: “Avid’s new state-of-the-art commercial bio-mfg. suite has been formally commissioned. The new facility will double the company’s prior mfg. capacity, supporting up to an addl. $40mm in revenue each year. As of Feb. 1, 2016, Avid Bioservices had a revenue backlog in excess of $58 million under committed contracts from existing clients, covering services to be completed in Q4/FY'16 [q/e 4-30-16] and into FY 2017.” http://tinyurl.com/gom7md5
3-7-16/Avid II: Formal Commissioning of Avid's New 40,000sq "Myford" Facility, “single-use/fully disposable” (potentially $40M addl revs) – S.King: “We have already had a tremendous response to the new facility and look forward to continuing to grow our bio-mfg. business which is an integral part of our overall business strategy." http://tinyurl.com/za2j9mt
12-11-15/BioPharma: Avid Expansion into MYFORD Facility (Avid II) now GMP-run ready (potential +$40mm sales) - contemplating further expansion http://tinyurl.com/z35623w
12-10-15/CC – Robert Garnick: “With the Myford site (Avid II) now in the initial phase of GMP manufacturing, we have seen a significant increase in demand for production capacity. Although, we have just opened the doors at Myford, we are already contemplating our options to increase further mfg. Capacity. Although no decisions have been made, we are pleased to have what appears to be a growing opportunity in this important area of our business.”
= = = = = = = = = = = = = = http://tinyurl.com/gom7md5
As of 1-31-16, Avid's Cust.Deposits=$22.4mm & Deferred.Revs=$15.4mm bode well for FY16/Q4 (q/e 4-30-16), with FY'16 Guidance raised to “over $40mm” and 1st 3 qtrs now at Revs=$25.6mm – ie, looking at $14.5mm+ for Q4/FY16 (q/e 4-30-16)...
• 3-9-16: FY'16 (May'15-Apr'16) Avid revs guidance raised from $35-40mm to “over $40mm”.
• Deferred-Revs at 1-31-16 total $15.4mm, UP from $9.7mm at 10-31-15.
• Cust.Deposits at 1-31-16 total $22.4mm, UP from $14.9mm at 10-31-15.
• Inventories at 1-31-16 total $15.2mm, UP from $12.6mm at 10-31-15.
• Avid’s Gross-Profit over last 3 qtrs: $12.3mm on revs of $25.6mm (GP%=48%)
Q/E Halozyme Cust-A/U.S. Other-Custs
4-30-14 91% 1% 8%
4-30-15 79% 12% 9%
7-31-15 84% 15% 1%
10-31-15 56% 41% 3%
1-31-16 64% 27% 9%
4-30-16 ????????????????????????
4-20-16/AACR'16 & 4-4-16/Cancer-Immunology-Res.(AACR) article, both describing preclin. data showing that Bavi combination I-O treatment (w/anti-PD-1 & anti-CTLA-4) “induces a shift in the tumor microenvironment from immunosuppressive to immune active” in Triple- Breast Cancer & Melanoma. 4-20-16 PR references a “planned clinical trial of bavituximab in combination with AstraZeneca's durvalumab under a clinical collaboration”. The AACR'16 poster #5116 (PPHM/U.Cal-Irvine) PDF now on Peregrine's website: http://www.peregrineinc.com/images/stories/pdfs/aacr-2016-gray.pdf
4-20-16/AACR'16 PR: Preclinical Data Presented at American Association for Cancer Research (AACR) Annual Meeting Demonstrate Enhanced Therapeutic Benefit of Combining a PS-Targeting Antibody With Anti-PD-1 Therapy in Models of Triple Negative Breast Cancer (TNBC)
* Statistically Significant Improvement in Overall Survival for Combination as Compared to Anti-PD-1 Therapy Alone in TNBC Models; Combination Also Protects Against Re-Challenge With TNBC Tumor Cells
* Novel Genetic Analysis Technology Further Validates Immune Modulating Mechanism of Bavituximab and Anti-PD-1 Combination; Supports Clinical Evaluation of Bavituximab and I-O Agent Combinations
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=965932
TUSTIN, April 20, 2016: Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM, PPHMP), a biopharmaceutical company focused on developing therapeutics to stimulate the body's immune system to fight cancer, today announced the presentation of preclinical study data demonstrating enhanced anti-tumor activity and immune activation for a combination of the preclinical bavituximab equivalent (ch1N11) and anti-PD-1 therapy in models of breast cancer including triple negative breast cancer (TNBC). Additionally, new analysis conducted using the nCounter ® PanCancer Immune Profiling Panel from NanoString Technologies ® further validated previously reported findings showing that the combination treatment induced a shift in the tumor microenvironment from immunosuppressive to immune active. This was evidenced by a distinct change in immune cell phenotypes, as well as an increase in immune activating cytokines and decrease in immunosuppressive cytokines. These study results, which were presented at the 2016 American Association for Cancer Research (AACR 2016) Annual Meeting, provide further support for Peregrine's strategy of evaluating bavituximab in combination with a range of novel immuno-oncology (I-O) agents for the treatment of various cancers.
"These presented study results, particularly the significant increase in overall survival and immunity to tumor re-challenge seen with the treatment combination as compared to anti-PD-1 therapy alone, continue to strengthen our collection of translational and preclinical data supporting the potential for bavituximab to enhance the therapeutic impact of I-O agents in the treatment of cancer. In doing so, these data provide further rationale for our clinical strategy focused on studying bavituximab in combination with I-O agents targeting the PD-1/PD-L1 pathway in a range of cancers," stated Jeff T. Hutchins, Ph.D., Peregrine's VP, Preclinical Research. "With a wealth of supportive research in hand, we look forward to the continued advancement of our clinical collaborations with AstraZeneca, the National Comprehensive Cancer Network [NCCN] and Memorial Sloan Kettering Cancer Center, to further evaluate the therapeutic potential of bavituximab with novel I-O agent combinations."
Bavituximab is an investigational immunotherapy designed to assist the body's immune system by targeting and modulating the activity of phosphatidylserine (PS), a highly immune-suppressive signaling molecule expressed broadly on the surface of cells in the tumor microenvironment. Peregrine's PS signaling pathway inhibitor candidates, including bavituximab, reverse the immunosuppressive environment that many tumors establish in order to proliferate, while also activating immune cells that target and fight cancer. The preclinical equivalent of bavituximab, ch1N11, is used in animal model studies as a guide for clinical development.
As part of the study that was presented at AACR [Poster #5116 PPHM/Friemark, U.Cal-Irvine/CW-Hughes http://www.peregrineinc.com/images/stories/pdfs/aacr-2016-gray.pdf ], researchers evaluated the combination of ch1N11 and anti-PD-1 therapy versus anti-PD-1 stand-alone therapy in two well-characterized murine models of TNBC (EMT-6 and E0771). Study data showed that the combination therapy significantly enhanced overall survival (p=0.0155) and was capable of mediating complete tumor regressions in a greater number of subjects compared to single agent treatments (60% vs. 20%). Data also demonstrated that animals receiving combination treatment had significant increases in tumor associated indicators of immune system activation, including CD45+, CD8+ and CD3+ T-cells. Importantly, the combination treatment led to a prolonged anti-tumor immune response which protected the animals that achieved a complete tumor regression against a re-challenge with the same E0771 TNBC model tumor cells. This sustained anti-tumor response demonstrates the ability of the combination treatment to trigger immune system memory and support adaptive immune responses against reemerging disease in this TNBC model. All study animals experienced no signs of adverse effects or weight loss following repeated doses of all therapeutic agents.
About Bavituximab: A Targeted Investigational Immunotherapy
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 developing therapeutics to stimulate the body's immune system to fight cancer. The company is focused on evaluating its lead immunotherapy candidate, bavituximab, in combination with a range of novel immuno-oncology (I-O) agents for the treatment of various cancers. One specific component of this I-O combination strategy includes a planned clinical trial of bavituximab in combination with durvalumab, AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor, under a clinical collaboration.
In addition to its drug development programs, Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com ), which provides development and biomanufacturing services for both Peregrine and third-party customers. For more information, please visit http://www.peregrineinc.com .
Safe Harbor *snip*
Jay Carlson, Peregrine Pharmaceuticals, Inc., 800-987-8256 info@peregrineinc.com
Stephanie Diaz (Investors), Vida Strategic Partners, 415-675-7401 sdiaz@vidasp.com
Tim Brons (Media), Vida Strategic Partners, 415-675-7402 tbrons@vidasp.com
Apr17-20 2016: AACR 2016, New Orleans
http://www.aacr.org/Meetings/Pages/MeetingDetail.aspx?EventItemID=63
Abstracts: http://www.aacr.org/Meetings/Pages/MeetingDetail.aspx?EventItemID=63&DetailItemID=363
4-20-16/Wed. 7:30-11am, Session: IMMUNOMODULATION & IMMUNOTHERAPY
#5116: “Phosphatidylserine-Targeting Antibodies Augment Anti-Tumor Activity of PD-1 Antibodies and Alter Immuno-Profiles in Murine Triple Negative Breast Cancers”
Michael J. Gray 1, Jian Gong 1, Ryan N. Parks 1, Michaela M.S. Hatch 2, Van Nguyen 1, Christopher C.W. Hughes 2, Jeff T. Hutchins 1, Bruce D. Freimark 1
1=Peregrine Pharmaceuticals; 2=Univ. of Calif./Irvine
ABSTRACT: Current treatments for triple negative breast cancers rely primarily upon surgical intervention and chemotherapy. Unfortunately, chemotherapies have the propensity to help establish an immunosuppressive condition in part though exposure of phosphatidylserine (PS) in the tumor microenvironment. We demonstrate that treatment of the murine triple negative breast cancer E0771 using a PS-targeting antibody inhibits in vivo growth, and significantly enhances the anti-tumor activity of antibodies directed to the checkpoint inhibitor PD-1. Combinational treatment by antibodies targeting PS & PD-1 increased the number of tumor infiltrating lymphocytes (TILs) to a greater extent than observed with single-arm therapies. Furthermore, combination of PS & PD-1 targeting antibodies provides a distinct survival advantage over treatment by either agent alone, which correlates with an increase in complete tumor regression and the onset of a durable immune mediated response capable of rejecting a secondary challenge by the same tumor. Finally, immune-profiling analysis of tumor RNA using Nanostring revealed that the combination antibody therapy enhanced immune regulatory pathways including MHC class I/II expression, antigen processing and presentation, and leukocyte and macrophage functions. Combined, our data suggest that in triple negative breast cancers antibody therapy blocking PS-associated immunosuppression may further enhance immunotherapies directed at immune checkpoint inhibitors, including those targeting the PDL-1/PD-1 axis.
Poster #5116 PDF: http://www.peregrineinc.com/images/stories/pdfs/aacr-2016-gray.pdf
- - - - - - - - -
Peregrine Exhibiting at Booth #2318 (across from MDAnderson #2312)
http://www.aacr.org/Documents/16AM_Exhibits_ListasofApr4.pdf (see rt.side bottom)
= = = = = = = = = = = = = = = = = = = = = = =
4-4-16/Cancer-Immunology-Res.(AACR) article, “PS Blockade Enhances Antitumor Responses to CTLA-4 & PD-1 Antibodies in Melanoma” - Xianming Huang(UTSW/Brekken Lab), Bruce Freimark, Rolf Brekken(UTSW), 9 others…
4-4-16: “Antibody-Mediated Phosphatidylserine Blockade Enhances the Antitumor Responses to CTLA-4 & PD-1 Antibodies in Melanoma”
Cancer Research Institute Journal (AACR) – Rec.10-2-15, Rev.12-29-15, Acc.1-20-16, PubOnline=4-4-16
http://cancerimmunolres.aacrjournals.org/content/early/2016/04/02/2326-6066.CIR-15-0250.abstract
FULL(32pgs): http://cancerimmunolres.aacrjournals.org/content/early/2016/04/02/2326-6066.CIR-15-0250.full.pdf
Bruce D Freimark 1, Jian Gong 1, Dan Ye 2, Michael J. Gray 3, Van Nguyen 1, Shen Yin 1, Michaela M.S. Hatch 4, Christopher C W Hughes(PPHM SAB) 4, Alan J Schroit(PPHM SAB) 5, Jeff T Hutchins 1, Rolf A Brekken(PPHM SAB) 2, Xianming Huang 2
1 Preclinical Research, Peregrine Pharmaceuticals, Inc.
2 Hamon Ctr for Therapeutic Oncology Res., Depts of Surgery/Pharmacology, UTSW-MC/Dallas
3 Preclinical Research, Peregrine Pharmaceuticals
4 Molecular Biology & Biochemistry, Univ. of California, Irvine
5 Simmons Cancer Center, UTSW/Dallas
ABSTRACT
In tumor bearing animals, the membrane phospholipid phosphatidylserine (PS) suppresses immune responses, suggesting that PS signaling could counteract the antitumor effect of antibody-driven immune checkpoint blockade. Here we show that treating melanoma-bearing mice with a PS-targeting antibody enhances the antitumor activity of downstream checkpoint inhibition. Combining PS-targeting antibodies with CTLA-4 or PD-1 blockade resulted in significantly greater inhibition of tumor growth than did single agent therapy. Moreover, combination therapy enhanced CD4+ and CD8+ tumor-infiltrating lymphocyte numbers; elevated the fraction of cells expressing the pro-inflammatory cytokines IL2, IFNy, and TNFa; and increased the ratio of CD8 T cells to myeloid-derived suppressor cells and regulatory T cells in tumors. Similar changes in immune cell profiles were observed in splenocytes. Taken together, these data show that antibody-mediated PS blockade enhances the antitumor efficacy of immune checkpoint inhibition.
. . .
IN SUMMARY(Pg.17): In summary, we have shown that PS-targeting antibodies improve the efficacy of anti-CTLA-4 or anti-PD-1 therapy in murine models of melanoma, suggesting that these combinations have the potential to improve outcome in patients with advanced stage melanoma. Bavituximab, a chimeric PS-targeting antibody, is currently being evaluated in late-stage clinical trials for the treatment of cancer patients with solid tumors (46,54) and strong antitumor activity has been demonstrated in melanoma clinical trials using checkpoint inhibitor antibodies targeting CTLA-4 (10), PD-1 (12,13), and PD-L1 (55). It is increasingly apparent that successful immunotherapy requires tumor cell killing, induction of pro-inflammatory immune responses and concomitant reduction of immunosuppressive signals leading to increased tumor infiltration by activated T cells. Based on the distinct mechanism of action and multiple points of blockade, PS-targeting antibodies such as bavituximab may enhance the anti-tumor responses of immune checkpoint inhibitors by further blocking suppressive signals in the tumor microenvironment.
= = = = = = = = = = = = = = = = = = = = =
BAVI MOA 1-18-16: CEO Steve King explains PPHM's direct PS-Targeting advantage vs. the “individual-receptors” PS-binding approach of others like: Axl Mer TIM-3 RAGE Tyro3 GAS6 CD300a BAI1 MFG-E8 etc. http://tinyurl.com/h2h87mc
2-2016: Rutgers' Dr. Raymond Birge's relationship with Peregrine & UTSW's Dr. Rolf Brekken and his 2-26-16 article, ”Phosphatidylserine is a Global Immunosuppressive Signal in Efferocytosis, Infectious Disease, and Cancer” http://tinyurl.com/z5d9qt9
11-9-15 SITC'15: New Bavi+Checkpoint Inhibitors preclin. data (UTSW/DUKE's Herbert K. Lyerly) http://tinyurl.com/pbof95w
...Also, collab. with Dr. Bernard Fox (Immunotherapist/Earle A. Chiles Res.Inst.) on new Immuno-Profiling Clinical Test (Opal 6-plex quantitative IF Assay), PPHM roundtable with Raymond Birge (Rutgers), Douglas Graham (Emory), Dmitry Gabrilovich (Wistar), Rolf Brekken (UTSW), Maria Karasarides (AstraZeneca) - ”Combining Bavi w/anti-PD-1 significantly enhanced O/S… significant incr. CD45+, CD8+ and CD3+ T-cells… led a prolonged anti-tumor immune response which protected the animals against a re-challenge w/same tumor.”
BAVI MOA 8-26-15: Jeff Hutchins(VP/PreClin-Res) ImVacS’15 Talk – 29pg. Slideshow http://tinyurl.com/qz64pzg
…“Expansion & Activation of T Cells via the Targeting of the Immunosuppressive Ligand PS: Combination Strategy with Conventional, Targeted, and Checkpoint Inhibitor Therapy”
5-31-15: ASCO’15 Roundtable (webcast), “Raising the Immuno-Oncology Bar” - 7 panel members, incl. 3 Sloan Kettering researchers http://tinyurl.com/qxu4w2x
BAVI MOA 3-25-15: PPHM/VP Dr. Jeff Hutchins’ presentation at "Immune Checkpoint Inhibitors Conf.", Boston - PDF(34 Slides): http://tinyurl.com/ooxkhq7
BAVI MOA 2-9-15: PPHM's Dr. Bruce Freimark’s presentation at KEYSTONE "Tumor Immunology Meeting", Banff/CN – PR & Slides: http://tinyurl.com/q6cx4w6
BAVI MOA 12-12-14 San Antomio Breast Cancer Symposium, Dr. Bruce Freimark, Bavi+anti-PD-1 vs. Breast Cancer http://tinyurl.com/p5ng6vs
4-20-16/PR: Added to ABOUT-PEREGRINE Section… TO ME, it says something's been decided with AZN. Will it be the originally planned Ph2/n=198 Bavi+durva 2ndLine NSCLC trial ( http://www.clinicaltrials.gov/ct2/show/NCT02673814 ) or something different? We'll see!!
3-9-16 ABOUT PEREGRINE:
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company developing therapeutics to stimulate the body's immune system to fight cancer. The company is focused on evaluating its lead immunotherapy candidate, bavituximab, in combination with a range of novel immuno-oncology (I-O) agents for the treatment of various cancers.
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=959623
4-20-16 ABOUT PEREGRINE:
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company developing therapeutics to stimulate the body's immune system to fight cancer. The company is focused on evaluating its lead immunotherapy candidate, bavituximab, in combination with a range of novel immuno-oncology (I-O) agents for the treatment of various cancers. ADDED: One specific component of this I-O combination strategy includes a planned clinical trial of bavituximab in combination with durvalumab, AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor, under a clinical collaboration.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=122045025
Recall, the SUNRISE stopped PR was on 2-25-16: http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=957281
4Our, “The preclinical equivalent of bavituximab, ch1N11, is used in animal model studies as a guide for clinical development.”
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.”
“Bavituximab is an investigational immunotherapy designed to assist the body's immune system by targeting and modulating the activity of phosphatidylserine (PS), a highly immune-suppressive signaling molecule expressed broadly on the surface of cells in the tumor microenvironment. Peregrine's PS signaling pathway inhibitor candidates, including bavituximab, reverse the immunosuppressive environment that many tumors establish in order to proliferate, while also fighting cancer by activating immune cells that target and fight cancer. The preclinical equivalent of bavituximab, ch1N11, is used in animal model studies as a guide for clinical development.”
= = = = = = = = = = = = =Peregrine's Anti-PS Mabs:
• PGN635 (B2GPI-dep.) is Fully-Human Bavituximab=1N11=AT004 (B2GPI-depen.); Genentech studying 89Zr-PGN635 as a Tumor Imaging Agent, “indep. of cancer type”
• PGN632 (B2GPI-indep.) is the Duke-PPHM-HIV candidate=11.31=AT005; also being studied by PPHM+LSU vs. Ocular Herpes (Acute HSV-1 Keratitis), see http://tinyurl.com/cax9a4p
• PGN650 is a human F(ab’)2 fragment that targets PS expression (1st ref’d in AACR’12 #2452) – see http://tinyurl.com/76nqqkm . 124I-PGN650 is Peregrine’s PS-Imaging candidate (see http://tinyurl.com/7p7jovt )
• BETABODIES (Clipped/Nicked B2GPI - ex: KL15, “2nd-gen. PS-Targeting”) - bind to PS directly, are smaller in size (100 vs. 250KDa) and have a longer serum half-life (~5days) than natural antibodies (Bavi=~1day) – see http://tinyurl.com/khopa3d
…2/17/15: UTSW/PPHM’s BetaBodies patent#8,956,616 Awarded(Granted) http://tinyurl.com/p75uyfu
KRAK: Extra Healing Prayers & Good Wishes to you today. I know I speak for the entire board, you good man.
4-18-16: CEO Steve King Quoted in BioProcessIntl Report on Cancer Immunotherapies (12pg. Report by Angelo DePalma, PhD)...
4-18-16: “Cancer Immunotherapies: Fulfilling the Promise of Protein & Cell Therapies”
by Angelo DePalma, PhD...
http://www.bioprocessintl.com/manufacturing/cell-therapies/cancer-immunotherapies-fulfilling-the-promise-of-protein-and-cell-therapies
PDF(12pgs): http://www.bioprocessintl.com/wp-content/uploads/2016/04/SpecRPT-Immunotherapy.pdf
With few exceptions, both small-molecule and biological cancer treatments have contributed only incrementally towards achieving long-term responses or outright cures. In this regard, emerging cell- and protein-based cancer immunotherapies represent game-changing strategies for treating even refractory cancer. With long-term responses now possible, medical science may be on the verge of delivering on the long-unfulfilled promise of making cancer a manageable disease. But impediments to commercializing cancer immunotherapies are substantial. Producing cell-based treatments entails substantial hands-on manipulation and perfecting the logistics of harvesting and expanding therapeutic cells and delivering them to patients. Given the handling requirements and high cost of goods (CoG) for cell-based immunotherapies, reimbursement considerations will force developers to demonstrate indisputable value. Those developing immunotherapies based on monoclonal antibodies (MAbs) will experience fewer such issues thanks to platform manufacturing technologies, but even they are likely to be priced to perfection.
Issues In Protein Immunotherapy - ”Immunotherapy Squared” Bavituximab, a monoclonal antibody from Peregrine Pharmaceuticals (Tustin, CA), is a classic protein immunotherapy targeting phosphatidylserine (PS), a novel immune system checkpoint. PS exists on the inside membrane layer of every cell, but it externalizes when cells die. “In circulation, PS signals the immune system to engulf dying cells,” explains Steve King, Peregrine’s CEO. PS also limits the immune response. As tumors proliferate, they often outgrow their blood supply so that many cells die, sending more PS into circulation. Tumors also release microparticles containing PS, ultimately suppressing immune response to the tumor by keeping the host’s immune system busy fighting particles and dead cells.
Peregrine’s collaboration with AstraZeneca for clinical development could be described as “immunotherapy squared.” Bavituximab’s presumed mode of action is to block immunosuppression while activating a tumor-killing T-cell immune response. AstraZeneca’s investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab, targets the programmed cell death ligand PD-L1, which helps tumors go undetected by the immune system. Both companies believe that combining the enhanced T-cell–mediated antitumor activity with a checkpoint inhibitor will extend the ability of tumor-specific T-cells to attack cancerous cells.
Like many small biopharmaceutical companies with a promising pipeline product, Peregrine chooses to emphasize clinical development over manufacturing or process development, confident that if bavituximab succeeds in the clinic, then CoG issues will resolve themselves. “Our process flexibility assures that we could duplicate the entire facility and all its infrastructure in an open warehouse space almost anywhere,” Steve King affirms. “We built the current facility with the idea of supporting production lots early in commercialization. At that point you have substantial revenue, so all your manufacturing avenues open up. And the risk of sticking with the same systems, at the same scale, from a comparability standpoint is negligible.”
Downstream operations could very well become a bottleneck. Peregrine has learned through its contract manufacturing business, Avid Bioservices, that high yields — even from 1,000-L or 2,000-L bioreactors — impose operational & financial pressures on downstream processing and purification. Protein A affinity chromatography columns, for example, begin at about $1mm for resin alone and go up from there. “That’s a big investment for a small-to-midsized company,” King admits. Peregrine is handling such challenges through a hybrid approach of maintaining a revenue-generating mfg. business that mitigates the cost of preparing for commercialization of its own products. “Not many companies have that flexibility.”
Blocking the Immunity Blockers: In November 2015, Faron Pharmaceuticals (Turku, Finland). . . Read the rest of this 12-pg. Special Report in the eBook – Just fill out the form to view and download it.
ANGELO DEPALMA: PhD in organic chemistry from the SUNY/Stony Brook, freelance writer - was a chemist 1st at Brookhaven National Laboratory and then at Schering-Plough. For over 25yrs, has written for dozens of technical online & print publications, as well as product & service companies in biotechnology, bioprocessing, pharmaceutical chemistry, pharmaceutical development, drug discovery, and laboratory instrumentation.
S.King said this in the 2-25-16 CC: "We've never seen these #'s reported. It's quite perplexing. At this point, the performance of the Doce arm was just completely out in left field.”
= = = = = = = = = 2-25-16 CC Replay(16mins):
11:10/Q&A: RahulJasuja/Noble, “You said that the performance of the Doce/Ctl arm was higher than ever seen in such a trial?”
SK “Yes, we've never seen these #'s reported. It's quite perplexing… at this point, the performance of the Doce arm was just completely out in left field.”
http://edge.media-server.com/m/p/xfa9fy5v
4-4-16/Cancer-Immunology-Res.(AACR) article, “PS Blockade Enhances Antitumor Responses to CTLA-4 & PD-1 Antibodies in Melanoma” - Xianming Huang(UTSW/Brekken Lab), Bruce Freimark, Rolf Brekken(UTSW), 9 others…
4-4-16: “Antibody-Mediated Phosphatidylserine Blockade Enhances the Antitumor Responses to CTLA-4 & PD-1 Antibodies in Melanoma”
Cancer Research Institute Journal (AACR) – Rec.10-2-15, Rev.12-29-15, Acc.1-20-16, PubOnline=4-4-16
http://cancerimmunolres.aacrjournals.org/content/early/2016/04/02/2326-6066.CIR-15-0250.abstract
FULL(32pgs): http://cancerimmunolres.aacrjournals.org/content/early/2016/04/02/2326-6066.CIR-15-0250.full.pdf
Bruce D Freimark 1, Jian Gong 1, Dan Ye 2, Michael J. Gray 3, Van Nguyen 1, Shen Yin 1, Michaela M.S. Hatch 4, Christopher C W Hughes(PPHM SAB) 4, Alan J Schroit(PPHM SAB) 5, Jeff T Hutchins 1, Rolf A Brekken(PPHM SAB) 2, Xianming Huang 2
1 Preclinical Research, Peregrine Pharmaceuticals, Inc.
2 Hamon Ctr for Therapeutic Oncology Res., Depts of Surgery/Pharmacology, UTSW-MC/Dallas
3 Preclinical Research, Peregrine Pharmaceuticals
4 Molecular Biology & Biochemistry, Univ. of California, Irvine
5 Simmons Cancer Center, UTSW/Dallas
ABSTRACT
In tumor bearing animals, the membrane phospholipid phosphatidylserine (PS) suppresses immune responses, suggesting that PS signaling could counteract the antitumor effect of antibody-driven immune checkpoint blockade. Here we show that treating melanoma-bearing mice with a PS-targeting antibody enhances the antitumor activity of downstream checkpoint inhibition. Combining PS-targeting antibodies with CTLA-4 or PD-1 blockade resulted in significantly greater inhibition of tumor growth than did single agent therapy. Moreover, combination therapy enhanced CD4+ and CD8+ tumor-infiltrating lymphocyte numbers; elevated the fraction of cells expressing the pro-inflammatory cytokines IL2, IFNy, and TNFa; and increased the ratio of CD8 T cells to myeloid-derived suppressor cells and regulatory T cells in tumors. Similar changes in immune cell profiles were observed in splenocytes. Taken together, these data show that antibody-mediated PS blockade enhances the antitumor efficacy of immune checkpoint inhibition.
. . .
IN SUMMARY(Pg.17): In summary, we have shown that PS-targeting antibodies improve the efficacy of anti-CTLA-4 or anti-PD-1 therapy in murine models of melanoma, suggesting that these combinations have the potential to improve outcome in patients with advanced stage melanoma. Bavituximab, a chimeric PS-targeting antibody, is currently being evaluated in late-stage clinical trials for the treatment of cancer patients with solid tumors (46,54) and strong antitumor activity has been demonstrated in melanoma clinical trials using checkpoint inhibitor antibodies targeting CTLA-4 (10), PD-1 (12,13), and PD-L1 (55). It is increasingly apparent that successful immunotherapy requires tumor cell killing, induction of pro-inflammatory immune responses and concomitant reduction of immunosuppressive signals leading to increased tumor infiltration by activated T cells. Based on the distinct mechanism of action and multiple points of blockade, PS-targeting antibodies such as bavituximab may enhance the anti-tumor responses of immune checkpoint inhibitors by further blocking suppressive signals in the tumor microenvironment.
= = = = = = = = = = = = = = = = = = = = = = =
Apr17-20 2016: “AACR 2016”, New Orleans
http://www.aacr.org/Meetings/Pages/MeetingDetail.aspx?EventItemID=63
Abstracts: http://www.aacr.org/Meetings/Pages/MeetingDetail.aspx?EventItemID=63&DetailItemID=363
4-20-16/Wed. 7:30-11am, Session: IMMUNOMODULATION & IMMUNOTHERAPY
#5116: “Phosphatidylserine-Targeting Antibodies Augment Anti-Tumor Activity of PD-1 Antibodies and Alter Immuno-Profiles in Murine Triple Negative Breast Cancers”
Michael J. Gray 1, Jian Gong 1, Ryan N. Parks 1, Michaela M.S. Hatch 2, Van Nguyen 1, Christopher C.W. Hughes 2, Jeff T. Hutchins 1, Bruce D. Freimark 1
1=Peregrine Pharmaceuticals; 2=Univ. of Calif./Irvine
ABSTRACT: Current treatments for triple negative breast cancers rely primarily upon surgical intervention and chemotherapy. Unfortunately, chemotherapies have the propensity to help establish an immunosuppressive condition in part though exposure of phosphatidylserine (PS) in the tumor microenvironment. We demonstrate that treatment of the murine triple negative breast cancer E0771 using a PS-targeting antibody inhibits in vivo growth, and significantly enhances the anti-tumor activity of antibodies directed to the checkpoint inhibitor PD-1. Combinational treatment by antibodies targeting PS & PD-1 increased the number of tumor infiltrating lymphocytes (TILs) to a greater extent than observed with single-arm therapies. Furthermore, combination of PS & PD-1 targeting antibodies provides a distinct survival advantage over treatment by either agent alone, which correlates with an increase in complete tumor regression and the onset of a durable immune mediated response capable of rejecting a secondary challenge by the same tumor. Finally, immune-profiling analysis of tumor RNA using Nanostring revealed that the combination antibody therapy enhanced immune regulatory pathways including MHC class I/II expression, antigen processing and presentation, and leukocyte and macrophage functions. Combined, our data suggest that in triple negative breast cancers antibody therapy blocking PS-associated immunosuppression may further enhance immunotherapies directed at immune checkpoint inhibitors, including those targeting the PDL-1/PD-1 axis.
- - - - - - - - -
Peregrine Exhibiting at Booth #2318 (across from MDAnderson #2312)
http://www.aacr.org/Documents/16AM_Exhibits_ListasofApr4.pdf (see rt.side bottom)
= = = = = = = = = = = = = = = = = = = = =
BAVI MOA 1-18-16: CEO Steve King explains PPHM's direct PS-Targeting advantage vs. the “individual-receptors” PS-binding approach of others like: Axl Mer TIM-3 RAGE Tyro3 GAS6 CD300a BAI1 MFG-E8 etc. http://tinyurl.com/h2h87mc
2-2016: Rutgers' Dr. Raymond Birge's relationship with Peregrine & UTSW's Dr. Rolf Brekken and his 2-26-16 article, ”Phosphatidylserine is a Global Immunosuppressive Signal in Efferocytosis, Infectious Disease, and Cancer” http://tinyurl.com/z5d9qt9
11-9-15 SITC'15: New Bavi+Checkpoint Inhibitors preclin. data (UTSW/DUKE's Herbert K. Lyerly) http://tinyurl.com/pbof95w
...Also, collab. with Dr. Bernard Fox (Immunotherapist/Earle A. Chiles Res.Inst.) on new Immuno-Profiling Clinical Test (Opal 6-plex quantitative IF Assay), PPHM roundtable with Raymond Birge (Rutgers), Douglas Graham (Emory), Dmitry Gabrilovich (Wistar), Rolf Brekken (UTSW), Maria Karasarides (AstraZeneca) - ”Combining Bavi w/anti-PD-1 significantly enhanced O/S… significant incr. CD45+, CD8+ and CD3+ T-cells… led a prolonged anti-tumor immune response which protected the animals against a re-challenge w/same tumor.”
BAVI MOA 8-26-15: Jeff Hutchins(VP/PreClin-Res) ImVacS’15 Talk – 29pg. Slideshow http://tinyurl.com/qz64pzg
…“Expansion & Activation of T Cells via the Targeting of the Immunosuppressive Ligand PS: Combination Strategy with Conventional, Targeted, and Checkpoint Inhibitor Therapy”
5-31-15: ASCO’15 Roundtable (webcast), “Raising the Immuno-Oncology Bar” - 7 panel members, incl. 3 Sloan Kettering researchers http://tinyurl.com/qxu4w2x
BAVI MOA 3-25-15: PPHM/VP Dr. Jeff Hutchins’ presentation at "Immune Checkpoint Inhibitors Conf.", Boston - PDF(34 Slides): http://tinyurl.com/ooxkhq7
BAVI MOA 2-9-15: PPHM's Dr. Bruce Freimark’s presentation at KEYSTONE "Tumor Immunology Meeting", Banff/CN – PR & Slides: http://tinyurl.com/q6cx4w6
BAVI MOA 12-12-14 San Antomio Breast Cancer Symposium, Dr. Bruce Freimark, Bavi+anti-PD-1 vs. Breast Cancer http://tinyurl.com/p5ng6vs
I wonder if Dr.Hutchins will discuss the Sloan-Kettering results that Steve Worsley (VP/BusDev) revealed for the 1st time during the 3-9-16 CC? “We are also renewing the MSKCC contract for next year as we’ve seen exciting results thus far.” We'll know if they PR it, or maybe if Peregrine posts Dr. Hutchins' Mar16 Slide-Show PDF on the website in the next few days...
MAR15-17 2016: IMMUNE CHECKPOINT INHIBITORS CONF., BOSTON
http://immune-checkpoint.com (Peregrine is 1 of 9 Corp. Sponsors)
3-16-16: Clinical Stream: “Enhance Combination Strategies to Maximize Efficacy”
11am: Patrick Ott, DANA-FARBER, “Critically Evaluate Mult. CI's in Combination”
-------
3-16-16 11:30am: Jeff Hutchins (PEREGRINE/VP-PreClinRes), “Enhancing the Power of Checkpoint Inhibition by Simultaneously Blocking Upstream & Downstream Targets: The Role of Phosphatidylserine (PS), a Novel, Global Immune Checkpoint”
* Inhibiting PS using Bavituximab, a novel PS-signaling pathway inhibitor, blocks the immunosuppressive signal within the tumor microenvironment
* Assessing impact of immune stimulation through Fcy-receptor interaction on immune modulating cells
* Effects on multiple other immune effector cells will be presented
-------
12pm: James Vasselli, MACROGENICS, “Releasing the Brake: Enhancing Immunotherapy Through Rational Combos w/CI's”
1:30pm: Tara Gangadhar, U-Penn, “Overcoming Toxicities Associated w/Novel CI Immunotherapy”
2:00pm: Dirk Brockstedt, ADURO BIOTECH, “Discovery & Validation of the Next Generation of ICI's”
2:30pm: David Kaufman, MERCK, “Next-Gen.Biomarkers for the Era of Combo Cancer Immunotherapy”
= = = = = = = = = = = = = = =
3-9-16/CC - STEPHEN WORSLEY (VP/Business Dev.):
“As Joe provided an update on our collaborations with AstraZeneca and the NCCN, I’d like to provide an update on Peregrine’s other I-O-focused collaboration with the Memorial Sloan Kettering Cancer Center. The goal of this partnership is to evaluate combinations of bavituximab with other checkpoint inhibitors & immune stimulatory agents for the purpose of developing new and increasingly effective anti-cancer treatments. This work is advancing well. To date, we've seen initial signs of activity with new combinations with bavituximab and other treatment modalities, such as checkpoint blockers, T-Cell agonists, and radiation. Our plan is to spend the next year investigating these possible combination potentials. We are also renewing the contract for next year as we’ve seen exciting results thus far.”
http://tinyurl.com/gom7md5
PPHM's Jeff Hutchins(VP/PreClinRes) speaking 3-16-16/11:30am at Immune Checkpoint Inhibitors Conf. (Boston). I see they've added a speaker (U-Penn), and scrambled the speaker's times, moving Dr. Hutchins from 2pm to 11:30am...
Mar15-17 2016: Immune Checkpoint Inhibitors Conf., Boston
http://immune-checkpoint.com (Peregrine is 1 of 9 Corp. Sponsors)
3-16-16: Clinical Stream: “Enhance Combination Strategies to Maximize Efficacy”
11am: Patrick Ott, DANA-FARBER, “Critically Evaluate Mult. CI's in Combination”
-------
11:30am: Jeff Hutchins (PEREGRINE/VP-PreClinRes), “Enhancing the Power of Checkpoint Inhibition by Simultaneously Blocking Upstream & Downstream Targets: The Role of Phosphatidylserine (PS), a Novel, Global Immune Checkpoint”
* Inhibiting PS using Bavituximab, a novel PS-signaling pathway inhibitor, blocks the immunosuppressive signal within the tumor microenvironment
* Assessing impact of immune stimulation through Fcy-receptor interaction on immune modulating cells
* Effects on multiple other immune effector cells will be presented
-------
12pm: James Vasselli, MACROGENICS, “Releasing the Brake: Enhancing Immunotherapy Through Rational Combos w/CI's”
1:30pm: Tara Gangadhar, U-Penn, “Overcoming Toxicities Associated w/Novel CI Immunotherapy”
2:00pm: Dirk Brockstedt, ADURO BIOTECH, “Discovery & Validation of the Next Generation of ICI's”
2:30pm: David Kaufman, MERCK, “Next-Gen.Biomarkers for the Era of Combo Cancer Immunotherapy”
= = = = = = = = = = = = = = =
BAVI MOA 8-26-15: Dr. Jeff Hutchins(VP/PreClin-Res) ImVacS’15 Talk – 29pg. Slideshow http://tinyurl.com/qz64pzg
…“Expansion & Activation of T Cells via the Targeting of the Immunosuppressive Ligand PS: Combination Strategy with Conventional, Targeted, and Checkpoint Inhibitor Therapy”
5-31-15: ASCO’15 Roundtable (webcast), “Raising the Immuno-Oncology Bar” - 7 panel members, incl. 3 Sloan Kettering researchers http://tinyurl.com/qxu4w2x
BAVI MOA 3-25-15: PPHM/VP Dr. Jeff Hutchins’ presentation at "Immune Checkpoint Inhibitors Conf.", Boston - PDF(34 Slides): http://tinyurl.com/ooxkhq7
3-9-16/S.King: “Avid definitely has new clients that have come onboard...” - and that's ClientS plural… Q4/FY16(q/e 4-30-16) Avid revs guidance now min. $14.5mm...
3-9-16/CC Q&A: George Zavoico: ”Re: Avid, have you increased the number of clients you are actually working with now or will be working with?”
Steve King: “Yes, we definitely have new clients that have come onboard, and that’s what’s helping to drive some of the work we are seeing over in the Myford facility, the nice backlog in business for now building up over there. That’s been great, because when you build a facility, you're never quite sure what the response was going to be, but it’s been pretty overwhelming right now, which is good.” http://tinyurl.com/gom7md5
- - - - - - - - - - - -
3-9-16/Qtly-PR: “Avid’s new state-of-the-art commercial bio-mfg. suite has been formally commissioned. The new facility will double the company’s prior mfg. capacity, supporting up to an addl. $40mm in revenue each year. As of Feb. 1, 2016, Avid Bioservices had a revenue backlog in excess of $58 million under committed contracts from existing clients, covering services to be completed in Q4/FY'16 [q/e 4-30-16] and into FY 2017.” http://tinyurl.com/gom7md5
3-7-16/Avid II: Formal Commissioning of Avid's New 40,000sq "Myford" Facility, “single-use/fully disposable” (potentially $40M addl revs) – S.King: “We have already had a tremendous response to the new facility and look forward to continuing to grow our bio-mfg. business which is an integral part of our overall business strategy." http://tinyurl.com/za2j9mt
12-11-15/BioPharma: Avid Expansion into MYFORD Facility (Avid II) now GMP-run ready (potential +$40mm sales) - contemplating further expansion http://tinyurl.com/z35623w
12-10-15/CC – Robert Garnick: “With the Myford site (Avid II) now in the initial phase of GMP manufacturing, we have seen a significant increase in demand for production capacity. Although, we have just opened the doors at Myford, we are already contemplating our options to increase further mfg. Capacity. Although no decisions have been made, we are pleased to have what appears to be a growing opportunity in this important area of our business.”
= = = = = = = = = = = = = = http://tinyurl.com/gom7md5
As of 1-31-16, Avid's Cust.Deposits=$22.4mm & Deferred.Revs=$15.4mm bode well for FY16/Q4 (q/e 4-30-16), with FY'16 Guidance raised to “over $40mm” and 1st 3 qtrs now at Revs=$25.6mm – ie, looking at $14.5mm+ for Q4/FY16 (q/e 4-30-16)...
• 3-9-16: FY'16 (May'15-Apr'16) Avid revs guidance raised from $35-40mm to “over $40mm”.
• Deferred-Revs at 1-31-16 total $15.4mm, UP from $9.7mm at 10-31-15.
• Cust.Deposits at 1-31-16 total $22.4mm, UP from $14.9mm at 10-31-15.
• Inventories at 1-31-16 total $15.2mm, UP from $12.6mm at 10-31-15.
• Avid’s Gross-Profit over last 3 qtrs: $12.3mm on revs of $25.6mm (GP%=48%)
Q/E Halozyme Cust-A/U.S. Other-Custs
4-30-14 91% 1% 8%
4-30-15 79% 12% 9%
7-31-15 84% 15% 1%
10-31-15 56% 41% 3%
1-31-16 64% 27% 9%
4-30-16 ????????????????????????
Steve Worsley (VP/BusDev) 3-9-16 on Sloan Kettering Collab... Sorry if already posted – I've been very busy and may have missed. SW: “We are also renewing the MSKCC contract for next year as we’ve seen exciting results thus far”. Very nice to hear!
3-9-16/CC - STEPHEN WORSLEY (VP/Business Dev.):
“As Joe provided an update on our collaborations with AstraZeneca and the NCCN, I’d like to provide an update on Peregrine’s other I-O-focused collaboration with the Memorial Sloan Kettering Cancer Center. The goal of this partnership is to evaluate combinations of bavituximab with other checkpoint inhibitors & immune stimulatory agents for the purpose of developing new and increasingly effective anti-cancer treatments. This work is advancing well. To date, we've seen initial signs of activity with new combinations with bavituximab and other treatment modalities, such as checkpoint blockers, T-Cell agonists, and radiation. Our plan is to spend the next year investigating these possible combination potentials. We are also renewing the contract for next year as we’ve seen exciting results thus far.”
http://tinyurl.com/gom7md5
- - - - - - - - - - - - - - -
5-29-15: Peregrine Pharmaceuticals Enters Into Research Collaboration to Investigate Novel PS-Targeting Immunotherapy Combinations
• Research Collaboration to Focus on Exploring Potential Combinations of PS-Targeting Agents Including Bavituximab With Other Immune Modulators
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=915472
TUSTIN, May 29, 2015: Peregrine Pharmaceuticals, Inc., a biopharmaceutical company focused on advancing bavituximab, a novel immuno-oncology agent in Phase III development for the treatment of lung cancer, today announced that the company has entered into a sponsored research agreement with Memorial Sloan Kettering Cancer Center (MSK) to explore the potential of Peregrine's proprietary phosphatidylserine (PS)-targeting antibody platform. The goal of the research is to identify effective treatment combinations based on Peregrine's PS-targeting agents, including Peregrine's lead clinical agent bavituximab, with other checkpoint inhibitors or immune stimulating agents that will further guide the bavituximab clinical development program.
The studies at MSK will be performed under the direction of Taha Merghoub, PhD, [ http://www.mskcc.org/research-areas/labs/members/taha-merghoub-01 ] Associate Attending Biologist, Melanoma and Immunotherapeutics Service, Ludwig Collaborative and the Swim Across America Laboratory, a part of the laboratory of Jedd D. Wolchok, MD, PhD [ http://www.mskcc.org/research-areas/labs/jedd-wolchok ], a leader in the field of cancer immunotherapy. Dr. Wolchok serves as the Chief, Melanoma and Immunotherapeutics Service, Lloyd J. Old Chair for Clinical Investigation as well as an Associate Director of the Ludwig Center for Cancer Immunotherapy at MSK.
"The phosphatidylserine (PS) signaling pathway is a very interesting target for modulating the immune system's response to cancer. We look forward to exploring the potential of PS-targeting agents alone and with other immune modulators that may lead to novel advances in cancer therapy," said Dr. Wolchok.
As part of the collaboration, researchers at MSK will conduct research to further explore the combination of PS-targeting agents, including bavituximab, that block a primary immunosuppressive pathway thereby allowing anti-tumor immune responses with other immuno-stimulatory agents that enhance immune responses. Specifically, MSK researchers will examine the combination of bavituximab alongside models of checkpoint blockade that are unresponsive to inhibition or co-stimulation given the ability of bavituximab to reprogram myeloid derived suppressor cells (MDSC) and increase tumoricidal T-cells in tumors, a mechanism of action that is complementary to checkpoint blockade and T-cell activation.
"A key focus of the Wolchok Lab's research is studying novel immunotherapy combinations that work together to enable the immune system to recognize and destroy cancer. This collaboration will allow us to focus on the role and contribution of PS blockade therapy in determining which combination of the current and next generation of immune modulators is likely to increase the extent and amplitude of anti-tumor response. This important pre-clinical and translational work will potentially guide the design of the next generation of clinical studies with bavituximab," said Dr. Merghoub.
.
.
= = = = = = = = = = = = = = = = = = = = = = = = = = = = =
CEO Steve King 3-9-16/CC: “Peregrine remains a strong company with a valuable clinical asset and a rapidly growing biomanufacturing business. The important work of developing bavituximab as an anti-cancer therapeutic continues. 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.”
3-9-16 Qtly CC-Transcript, PR(Fins/Devs Q3FY16/qe1-31-16), updated Avid Revenues History Table By Quarter…
=> Total Revs May06-Jan16: $154.8mm/Avid + $24.1mm/Govt + $2.4mm/Lic. = $181.4mm. Cash at 1-31-16: $67.5mm
As of Mar. 8 2016, there were 233,738,426 shares outstanding.
This large post has 3 sections:
I. 3-9-16 Q3/FY16 Qtly. Earnings Conf. Call TRANSCRIPT (q/e 1-31-16)
II. 3-9-16 PPHM Press Release: Q3/FY16 Earnings & Developments
III. Updated Table of Avid Revenues By Quarter (May’06-Current)
…Recall: Peregrine’s FY runs May-Apr, so FY’16 = May’15-Apr’16.
((( Orig. transcript from SeekingAlpha.com [ http://tinyurl.com/hwm56ah ], with numerous corrections made. )))
Link to webcast replay: http://ir.peregrineinc.com/events.cfm => http://edge.media-server.com/m/p/iirfkpej
FULL TRANSCRIPT…
3-9-2016 FY’16/Q3 Earnings Conf. Call (q/e 1-31-16)
WELCOME & FWD-LOOKING STATEMENTS: Tim Brons, Vida Strategic Partners (IR) http://www.peregrineinc.com
Speakers: Steve King, Joe Shan, Stephen Worsley, Paul Lytle; Q&A session.
CEO STEVE KING – OPENING COMMENTS:
Thanks to all of you who have dialed in, and to all of you who are participating via webcast today. It is certainly been an interesting time at Peregrine since our last regularly scheduled conference call. On the downside was the recent announced discontinuation of our Phase III SUNRISE trial. On the upside was the announcement that we had completed formal commissioning of our new biomanufacturing facility and that the manufacturing in this facility was well underway, giving us a great new revenue source from which to continue growing the business, which this FY (FY16: May'15-Apr'16) will easily reach an all-time revenue high.
So, where do we go from here? First, we continue growing our thriving mfg. business, where we see the opportunity to grow even beyond the new mfg. facility. Demand for services is at an all-time high and, importantly, we are seeing significant opportunities for late-stage clinical and commercial production that can yield a solid base for future growth. So on this side of our business, it is business as usual, supporting our clients with their development and commercial production needs.
On the development side, it is a transition time for our bavituximab program. While the results of the interim analysis from the SUNRISE study are unfortunate, and it is a setback for our chemotherapy combinations with bavituximab, it is by no means the end of the program. For starters, we have not yet completed patient follow-up in the SUNRISE study, with the goal of learning as much as we possibly can from the trial. Important to note is that patients that enrolled in the study and are still active are continuing to receive chemotherapy and those patients that were on the bavituximab arm have the option to continue receiving bavituximab, and some have already expressed an interest in doing so. And, we will be continuing follow-up on these patients as well as survival follow-up of patients that have already exited the study. At this point, our goal for the study is to obtain data from the trial that can potentially be critical in how we move the chemotherapy combination program forward and even information that can help guide the overall program: which patients did particularly well in the study? what were their characteristics? - these are just a couple of examples of the many types of questions that we want to attempt to address as we wind down the SUNRISE trial, so that we can tailor patient selection in future studies. As we generate this data, we will be able to share it at the appropriate time in the future. As for advancing the program, we are as excited & confident as ever about the immuno-oncology combination potential of bavituximab. As you may recall, this was already the counterpart to the chemotherapy combinations based on a completely different mechanistic synergy; namely, to start an immune response in patients lacking a good immune response, and then prolong the immune response by blocking the PD-1/PD-L1 pathway that can counteract a strong immune response in patients. This combination hypothesis is still completely intact. We have generated a significant amount of translational & preclinical data demonstrating that bavituximab has the potential to enhance the activity of checkpoint inhibitors, and our goal for the coming year is to bring many of these concepts into the clinic and to demonstrate the potential of bavi in this important area of cancer therapy.
With our I-O combination program having been underway for sometime, long before the SUNRISE results, we have formed collaborations with some of the leading I-O players in the world: a collaboration with AstraZeneca to study bavi with their PD-L1 inhibitor durvalumab, a collaboration with researchers at Memorial Sloan Kettering Cancer Center to study novel combinations of bavituximab with I-O agents, a collaboration with National Comprehensive Cancer Network (NCCN) to run multiple clinical studies focused on I-O combinations at some of the 26 leading cancer centers in the U.S. that are part of the network, with significant involvements, as part of the program, from KOL's at those institutions, all in addition to our long time collaborations at the Univ. of Texas SW Med. Ctr. that will continue to be active in pushing forward I-O combinations. The main difference with the SUNRISE results in hand is that the I-O combination program has become our major area of clinical focus and, as such, we are working with all of our collaborators to redefine the program in order to have a cohesive & comprehensive strategy that ties together the efforts of all of our collaborators and will allow us to rapidly advance the program. The strategy will involve studies designed to answer specific questions about particular patient populations where we already have evidence that bavi may have the biggest impact, allowing us to more quickly generate data that we can build on as we advance the program. These planning efforts are well underway as we speak, and we look forward to updating you as they are implemented into the clinic. I will now turn the call over to Joe Shan, VP, Clinical & Regulatory.
JOE SHAN (VP/Clin.&Reg. Affairs) – CLINICAL TRIALS:
I’d like to start by speaking about our Phase III SUNRISE trial, which we discontinued in late February [2-25-16: http://tinyurl.com/jbg48vs ]. The decision to stop the trial was based on the recommendation on the study’s Independent Data Monitoring Committee (IDMC), following a pre-specified interim analysis. While the interim analysis showed that the bavituximab combination group was performing as expected according to the original trial assumptions in terms of overall survival, it also demonstrated that the docetaxel group had dramatically outperformed OS expectations based on the original trial assumptions and as compared to recently published studies. Nevertheless, enrollment has been stopped and we are now in the process of winding down the trial. As part of this process, patients who are still receiving study treatment are given the option completing their chemotherapy, and for those patients assigned to the bavituximab arm, they continue to receive bavituximab if the investigator believes this is in the patient’s best interest. Because I-O agents can elicit delayed responses and prolonged survival, we are continuing to follow such patients to evaluate their outcomes. Such information will certainly be valuable and help us form future decisions for the company. As we continue to collect and clean the remaining data, we are also conducting a thorough evaluation of the already available clinical data. While we perform these analyses, we’ve put a hold on the trials that combine bavituximab with chemotherapy until we have a clearer understanding of SUNRISE study results. Specifically, we have put our recently initiated Phase II/III breast cancer trial on hold, as well as the start-up activities for a Phase II early-stage breast cancer trial. It is our plan to publish our findings from SUNRISE when it is completed and we will provide an update on this process next quarter.
Looking ahead, our priority is to generate clinical evidence of bavituximab’s ability to improve patient outcomes when combined with immuno-oncology agents. To this end, AstraZeneca and we are currently evaluating a trial design for the 2 previously announced clinical trial combining bavituximab with AZ’s PD-L1 inhibitor durvalumab. In light of the recent development in the SUNRISE trial, our companies are currently working together to identify the optimal path forward for demonstrating potential mechanistic synergies between bavituximab & durvalumab in different patient populations. We are particularly interested in combing bavituximab with checkpoint inhibitors because it has been observed that checkpoint inhibitors are most effective when there is a pre-existing T-Cell response in tumors. Importantly, we have pre-clinical evidence that bavituximab-like antibodies trigger CD+ T-Cell responses which can be prolonged by the addition of PD-1 checkpoint inhibitors. Another important observation we’ve recently made is that our PS signaling pathway inhibitors demonstrate multiple signs of immune activation in low or negative PD-L1 expressing tumors. We believe that this holds great potential to increase the number of patients able to respond to checkpoint therapies. Based on these observations, we believe that by combining these 2 projects the potential exists for a more complete
& lasting anti-tumor immune response.
Lastly, I’d like to comment on our newest collaboration with the NCCN. The goal of this partnership is to build upon the company’s clinical dev. program of bavituximab in combination with I-O agents for the treatment of a range of tumors. NCCN is a not-for-profit, alliance of 26 of the world’s leading cancer centers dedicated to improving the quality, effectiveness, and efficiency of cancer care. Through this collaboration, Peregrine will have an opportunity to fund multiple investigator initiated clinical & correlative studies with bavituximab in a range of cancers at the NCCN member institutions and their affiliate community hospitals. We believe this relationship will prove to be highly valuable, as it will allow Peregrine to expand and augment our bavituximab clinical dev. program through experienced investigators & world-class institutions. It would be impossible for a company of our size & stage to gain access to incredible institutions and clinical thought leaders otherwise. This collaboration remains quite new, but we look forward to reporting our progress in the not too distant future. This concludes my comments today. I will now turn the call over to Steve Worsley to give an overview of the business dev. and mfg. activities.
STEPHEN WORSLEY (VP/Business Dev.):
As Joe provided an update on our collaborations with AstraZeneca and the NCCN, I’d like to provide an update on Peregrine’s other I-O-focused collaboration with the Memorial Sloan Kettering Cancer Center. The goal of this partnership is to evaluate combinations of bavituximab with other checkpoint inhibitors & immune stimulatory agents for the purpose of developing new and increasingly effective anti-cancer treatments. This work is advancing well. To-date, we have seen initial signs of activity with new combinations with bavituximab and other treatment modalities, such as checkpoint blockers, T-Cell agonists, and radiation. Our plan is to spend the next year investigating these possible combination potentials. We are also renewing the contract for next year as we’ve seen exciting results thus far.
I’d now like to discuss our biomanufacturing business, Avid Bioservices, as we announced earlier this week, our new state-of-the-art commercial biomanufacturing suite, which we call the Myford facility, has been formally commissioned [3-7-16: http://tinyurl.com/za2j9mt ]. As part of the commissioning process, all relevant regulatory agencies have been notified and GMP production is currently underway. The new facility, which is being operated by Avid Bioservices, will more than double the company’s prior mfg. capacity. The 40,000sf biomanufacturing facility, which is located adjacent to the company’s current campus in Orange County, is outfitted with cutting-edge, single-use equipment to accommodate a fully disposable biomanufacturing process for late Phase III clinical & commercial production of biologics. Despite its world-class design, the Myford facility was completed for a fraction of the cost of building comparable facilities, something of which we are quite proud. The suite is capable of operating reactors as large as 2000 liters in volume. GMP material produced in new facility can be used either in clinical trials or for commercial sales once Peregrine or its partners make the appropriate regulatory filings. Demand for this new production capacity is high, and we already have locked commitments extending well into 2017. As this demand continues to grow, it leads us to consider options for potentially adding more production capacity in the near future. We are currently evaluating a number of opportunities to meet this demand and are extremely optimistic about the growth of this business. We believe that the Avid business will continue to be a tremendous source of new business for Peregrine, and it is our goal to pursue every opportunity to build demand and expand capacity. That concludes my comments. I will now turn the call over to CFO Paul Lytle who will discuss the company’s financial performance, including addl. details regarding our Avid Bioservices business.
CFO Paul Lytle:
We are pleased to report that we continue to see significant growth in our contract mfg. business. Last qtr, we raised our FY'16 [May'15-Apr'16] revenue guidance from $30-35mm to $35-40mm and today, we believe we can exceed this guidance and top $40mm in contract mfg. revenues for the full FY'16. This represents revenue growth of ~50% over the prior FY, in addition to the continued growth we’ve seen over the last several years. I would also like to point out that our mfg. revenue for the full FY'16 will be solely derived from our existing mfg. facilities and our newly commissioned facility has the potential to generate an addl. $40mm in mfg. revenue.
Turning to the current qtr, we generated contract mfg. revenue of $6.6mm, representing an 18% increase compared to the same prior year qtr, and YTD we recorded mfg. revenue of $25.6mm or a 47% increase compared to the same prior year period. Our outlook for this business remains very positive, with our customers continuing to book available production capacity. Our revenue backlog has grown from $49mm reported in the last qtr to over $58mm as of Feb. 1, 2016, the beginning of our Q4. Looking ahead, we expect Avid Bioservices to continue to play a critical role in our business. Avid continues to generate non-diluted income that significantly reduces the amount of capital we need to raise by other means. For this reason, growing the Avid business will remain a high priority for the company.
Now turning to expenses, R&D expenses for the qtr increased primarily due to the increased mfg. costs associated with bavituximab, combined with increased cost associated with the previously planned Phase II trials in breast cancer & lung cancer, while G&A expenses remained relatively flat qtr-over-qtr. A more detailed analysis of our statement of operations is included in our Form 10-Q that will be filed later today [10-Q: http://tinyurl.com/hdgto9y ]. This concludes my financial overview, and I will now turn the call back over to Steve to discuss some important upcoming milestones.
CEO STEVE KING – MILESTONES:
As you’ve heard from our team today, Peregrine remains a strong company with a valuable clinical asset and a rapidly growing biomanufacturing business. The important work of developing bavituximab as an anti-cancer therapeutic continues. We believe our relationships with AstraZeneca, Memorial Sloan Kettering, UT Southwestern, and with the NCCN will be invaluable as we establish & execute our overall strategy for advancing the bavituximab I-O combination plans in a range of cancers. And, our Avid Bioservices business continues to outpace our initial projections providing a steady growing revenue stream. The Avid business grew 20% in FY'15 to $26.7mm in revenue, and is expected to exceed $40mm in FY'16, with our new “Myford” facility now online to help drive further growth in FY'17. It is fair to say that Avid has experienced significant success, and we are evaluating a number of opportunities to continue to expand this important business. This concludes our prepared remarks and we would now like to open the line for questions.
Q&A: [19:10 mark]
1. Joe Pantginis – Roth Capital Partners: [ http://www.roth.com & https://roth2.bluematrix.com/docs/pdf/BLUE.pdf ]
JP: ”With regard to the overall operations of Peregrine, you are obviously looking at increased revenue from Avid, so with that in mind, how are you looking to fund the company going forward with regard to the Avid revenues, your outstanding ATM, and is there a potential for restructuring following the SUNRISE news?”
Paul Lytle: That’s a good question, Joe. We are very committed to maintaining a solid cash position to run our business. We’ve always said in the past that our goal is to maintain a balanced financial approach, so we like to complement our cash position with the revenues that are coming in for Avid. We can utilize potential offerings through the equity markets if we need to and then obviously we're looking at other opportunities. Different collaborations, different revenue streams, and growing the Avid business I think will be imperative for the company as we advance our business. So, again we are looking at maintaining and sustaining a very operational business here and to support our customers.
JP: ”And with regard to the size of the business and any potential restructuring?”
Paul Lytle: Currently, we have no restructuring in terms of the size of the business. Our goal is to continue to grow the business and we have plans to do that.
JP: ”OK, and switching to the I-O combination program, Steve, you made a comment about how the program is going to be redefined now, can you talk a little more about what that means; specifically, I know you had some certain views about what the AZ protocols might have looked like. Have those changed and what have your discussions been with AstraZeneca since the SUNRISE news?
Steve King: One of the things we’ve done, which is prudent, is, based on the SUNRISE data and the fact that we really need to understand what happened in that study - why did the control arm way outperform what we expected going into it. As Joe mentioned in his remarks, we have put on hold a couple of the clinical studies that would have been starting otherwise. This does two things – one, it gives us a chance to give more data from the SUNRISE trial and to make sense out of it; the 2nd is that it also controls expenditures in those areas and those were a couple of significant expenditures for the coming year. In addition, our overall strategy, and this pertains to both questions, is really to focus our clinical dev. efforts on studies that can yield, #1, quick data or as quick as possible, but also smaller studies that really allow us to build on early successes and then to grow our knowledge base as we expand into larger trials. It’s a huge benefit to be able to do that based on the tale, if you will, of good clinical data. Yes, we’ve entered into discussions with AstraZeneca, we are having discussions with NCCN, with our other collaborators at Sloan Kettering & UT Southwestern about, how do we put together a cohesive program, because we don’t want a bunch of individual activities that don’t fit well together, what we want is a program that allows us to answer critical questions in multiple indications simultaneously and then to build on solid clinical data, looking at patient populations such as PD-L1 negative, where we have already shown in some of our translational work and pre-clinical studies that may be where we can have a big impact, so we’ll be able to look at that in a clinical setting. But, taken overall, it also helps to control the burn rate until we can generate good clinical data that’s positive and then that of course should help both on the partnering as well as the funding fronts. So, we're taking this very step-wise, and continuing to grow the Avid business just makes good sense, because that really helps cover the overall business operations.
JP: ”Would you say that there has been no change to the tenor of your discussions with AstraZeneca?”
Steve King: What I would say is that the tenor of discussions has changed just because, what now makes the most sense, because the rationale for running the Phase II study in NSCLC was little bit different. It was really meant to augment a positive clinical study in chemo combination, and so they then had coverage for both the I-O combination as well as the chemotherapy combinations. I think now the goal has changed somewhat, and I think for both of us into, how do we now build on good clinical data and find those patient populations that are most likely to respond. So, it’s sparked of a lot of a new conversation, all which I think is very positive and I think also which will allow us to not just run studies with AZ, but also to incorporate what we are doing with NCCN, Sloan Kettering, UTSW into that overall plan which benefits both Peregrine & AstraZeneca and everyone involved.
JP: ”You mentioned re: SUNRISE that patients will be able to, if they request, remain on bavi. Do you have a sense of how many patients that might be, and the potential cost associated with it?”
Steve King: Yes, I think the potential cost will be relatively minimal just because, obviously, it’s going to be a portion of the patients that would be going forward with that, but it was already captured in the initial intent of running the study. But, the benefit far outweighs any expenditures associated with those infusions, because #1 we only have the drug, #2, it allows patients to stay on and as the data matures, our goal is still to get as much data from this study as possible, which includes which patient populations maybe doing better, is there a survival tale – a lot of questions we still want to answer and the more we are able to keep patients on the study, keep them going through, I think the more likely we are to be able to get some really nice data that we can again, really employ as we continue to advance the program.
2. Thomas Yip (FBR & Co.): http://www.fbr.com
TY: ”Re: your ongoing discussions with AstraZeneca, you mentioned it involves finalizing the design of 2 trials. I am just wondering whether it’s still a Phase II trial for NSCLC and then another trial for solid tumors, and if so, which one is the higher priority trial at this point?”
Steve King: Just to remind everyone, we had actually 2 separate collaborations. The 1st one was for a clinical basket-type study, in which we are looking multiple solid tumor indications, where the idea was to combine bavituximab with durvalumab + chemotherapy. The 2nd study was a Phase II study in NSCLC to combine bavi with durvalumab vs. durvalumab alone. Basically, what we want to do now is take a step back, we’ve got data from SUNRISE, what is that telling is - obviously it’s giving us a good reason to consider the trial design for the basket study. Do we at this point just simplify it and have it simply be a bavituximab + durvalumab study? Those are the kind of discussions that are ongoing. And then, on the Phase II NSCLC study, we're just taking a look at both of those studies and determining what is the right studies to run. My goal for the clinical program is, run studies in which we can quickly ask questions and answer questions and use that to guide the overall program. Whatt we want to do is make it the most efficient program. I think AstraZeneca really sees the value in that and, again, also to tie it in with what we are doing with NCCN, and UT Southwestern, and Sloan Kettering, so that, we get the value of a global program, not just of couple of clinical studies which will answer some questions but maybe leave others unanswered. I think that we are having very good discussions with AstraZeneca and we just want to come out with the best program overall that really allows us to rapidly generate data and to rapidly move the program forward.
TY: ”Can you tell us more detail about your NCCN collaboration? Specifically, what is the selection process of potential immuno-oncology combinations?”
Steve King: The process with NCCN, which is is pretty much kicking off, is that the NCCN is responsible for reviewing, putting together a proposal, and working with us to try to answer questions that are of interest to us, but at the end of the day, they are running the program. What’s important is, the NCCN is some of the leading cancer institutions in the U.S. In addition, it’s really the KOL's at those institutions who will be involved in our particular program and so, we couldn’t be in better hands than working with the key thought leaders to select and run clinical studies that will add the most value to our I-O combinations. So, they're responsible for it. We provide them with all the information we have to-date, where we see the gaps in the program, and then they basically take and run with it. Operationally, it’s great for us. It’s great to be involved with these leading institutions. It’s really just a win-win for us and for the investigators to be able to run these studies.
YP: ”Re: Avid's $58mm backlog, is this committed for Q4/FY16 (q/e 4-30-16) and for the full 4 qtrs of FY'17?”
Paul Lytle: Yes, it is revenue to be reported in Q4'16 and into FY'17.
3. George Zavoico – Jones Trading http://jonestrading.com
GZ: ”Sorry about SUNRISE. I was quite as surprised and the better than expected behavior of the control of docetaxel - that’s killed a bunch of Ph.3 trials already in the last several months - very unsettling patterns. But, we then see how it plays out with the patients that you are still treating. Re: the NCCN pgm, you mentioned in the PR that you are committing $2mm of research expense through the pgm. Can you give us an idea of the scope of what that can cover in terms of how many collaborations, how large the trials, how many trials you might be able to do, and also what the cost sharing aspect of it is? How much of it are you paying and how much of it, if any, is the NCCN contributing?”
Steve King: The funding we're committing [1-6-16: $2mm res. grant to NCCN http://tinyurl.com/zmxtpsb ] is really is our commitment to the program. Obviously providing bavituximab will be other piece of the commitment, but, clearly that’s not an issue, because we manufacture it here. The beauty of the NCCN, as I mentioned earlier, is #1 we’ve got KOL's involved in it, leading institutions who can help guide the program. The idea is that they will put out RFP's. We expect the funding will fund 3, 4, 5 different clinical studies; it’s going to depend on the scope of the studies and the proposals that come through. But basically for us it’s great, because they're operationalizing and running the studies. They obviously are picking sites that have a good track record in quick patient enrollment, good patient enrollment, and really adhering to what they’ve proposed in their proposals. So, for us it’s really a way to run multiple studies all under one umbrella at the same time to really again involve some of the key people that we want to be excited about the program as we go forward.
GZ: ”I presume that, because of the SUNRISE trial that was ongoing, I suspect you probably don’t have to make any more about bavituximab for a while, so that cost is pretty much covered already for these programs?”
Steve King: Yes, absolutely, we already have adequate stocks of bavituximab to support all these studies we are talking about. We don’t expect any of them to be huge studies to start with, but certainly we have more than adequate supplies on hand.
GZ: ”And I imagine that the $2mm is just a start, if things go pretty well, I'm sure that $2mm was not the ceiling here, right?”
Steve King: No, we can always adjust it. The $2mm is what the original agreement is for and so that covers all the initial scope of what we are trying to do with them. But, certainly if things goes we expect and we generate data we think that will help drive the program forward, we want to continue to work with NCCN and our other collaborators. Joe?
Joe Shan: This is basically a research agreement for $2mm, I think over a course of 2 years. So, maybe that gives you a sense of time and as Steve mentioned, typically it ends up being 4-6 investigator initiated trials. These are smaller studies, but I think the key is that, like Steve mentioned, it’s in our strategy of smaller quick studies that we can get.
GZ: ”Absolutely, you're tapping into an existing infrastructure at minimal cost...”
Joe Shan: Correct.
GZ: ”Given where you are now, that’s probably the best strategy to take. Re: timing, you said you are going to be entertaining RFPs. When do you think you might get the 1st trials underway?”
Joe Shan: I don’t think we have total clarity on that. We are starting that process of developing that RFP with the NCCN. Again, this is a program that they administer, they oversee, and that 2-yr period basically starts pretty soon. As soon as the RFP is developed, they’ll put it out and they are under contract to delivering study results and publications in a 2-yr timeframe.
GZ: ”Re: the MSKCC collab, you mentioned a couple of tantalizing comments that you're already seeing some interesting data. Maybe it’s too early, but can you comment on whether any aspects of it have been submitted for the AACR Meeting perhaps, or ASCO or later on in the fall? When will we start seeing some of the MSKCC data in other words?”
Steve King: Our Sloan Kettering collaboration is obviously ongoing in a number of different areas, and so far we have been very happy with the way it’s progressing. I think some of the data is coming through on that. I can’t comment on what they’ve submitted at this point, but certainly, the goal of both of our groups is to generate data that we can not only go out and present at major conferences like AACR, but also to publish and really help guide the clinical program. I think along those lines, it’s important to note that Memorial Sloan Kettering is one of the institutions within the NCCN, so, obviously that’s another nice fit of how we're putting everything together from a cohesiveness point. So, clearly we'd like nothing better than to see some of the great ideas from our collaborators end up in clinical studies and driving the program forward.
GZ: ”Re: Avid, you're working with certain margins on the pre-existing facility without the disposables. The disposables enable much less expensive manufacturing… how do you expect the margins to change with the new facility?”
Paul Lytle: In terms of our mfg. contracts, the mfg. fees are fairly consistent, whether it’s in stainless steel or it’s in single-use bioreactors. So we expect the revenue to be very similar. In terms of the cost structure, a significant portion of the cost structure is really built into labor and whether you are doing it with our traditional facility or with the single-use, the cost structure is fairly similar from a human resource standpoint. The one key thing here is that the changeover time between stainless steel & single-use is much quicker, so we can shrink the amount of time between mfg. runs and potentially drive a lot more output out of a single-use facility.
Steve King: The other nice thing about the Myford facility is that it really was built for late-stage clinical & commercial production; ie, meant to upgrade in campaign mode, which means that you will have multiple reactors going simultaneously for a given product and then have a changeover to the next product. So actually the throughput of the facility could be even greater than what we have in our existing facility as we get more and more commercial production. And, as I said in earlier prepared remarks, we’ve seen a lot of interest from late-stage clinical & commercial clients and that’s really going to be instrumental in building a nice solid base for continuing to grow the business, because what you want is to constantly produce materials, make as many batches as you need, and then switchover, because now the client has what they need from a production standpoint and it allows us to move on to the next client and continue our production lines in a continuous way. That’s really a model for how we see the commercial facilities, and we’ve also seen a nice, as we want to continue to grow the business, a really big need for addl. clinical production as well. So, that’s another area of potential growth for the business as we continue to move forward. We are continuing to respond to the market needs by building on a nice solid base of existing clients that will have long-term needs.
GZ: ”Re: Avid, are you considering at all expanding into fill and finish? Also, have you increased the number of clients you are actually working with now or will be working with?”
Steve King: Yes, we definitely have new clients that have come onboard, and that’s what’s helping to drive some of the work we are seeing over in the Myford facility, the nice backlog in business for now building up over there. That’s been great, because when you build a facility, you're never quite sure what the response was going to be, but it’s been pretty overwhelming right now, which is good. On the fill/finish side, that is something we do have an interest in, particularly to support our clinical clients, for those in clinical stages of developments, because it will be a big benefit for them and I think another draw for bringing in that early-stage business. Commercial mfg. is a different beast altogether, so that’s one that as we get experience in fill/finish and see that there's a good track record we’ve built up, then moving in a commercial production might be something down the road. But, right now, quite frankly, we are so busy with bulk drugs substance manufacturing, and we want to continue to do what we do well and continue to grow that business.
4. Rahul Jasuja - Noble Life Science Partners http://noblelsp.com/research
RJ: ”On the SUNRISE trial, looking at the remnants of what you can salvage in terms of data here, you talked about looking at the immuno therapy effect in the remaining patients that are on bavi, or choose to stay on bavi. What immunological metrics will you be looking for? Are you looking for just tumor reduction or are you looking for particular immune metrics in the tumor micro environment that you are collecting as well?
Steve King: It’s a combination of all the above. We built into the SUNRISE study a lot of collection of samples & specimens from patients throughout the study that would allow us to do analysis, but while the trial was blinded we wouldn’t really be able to make sense out of it. Now that the study is unblinded, we can actually do the analysis of those samples and then start to put that together with the actual patient outcomes. One of the things that we can monitor closely with our collaborators, through NCCN or through our collaborations with Sloan Kettering and UTSW is, what all do we want to learn now, and in particular focus on those patients that really did well in the study, because the ultimate goal is to be able to select patients for future studies that are more likely to respond to therapy. There is every likelihood that within the SUNRISE study, that that information could be available, and we just want to be very methodical in how we generate that data, the testing we do to make sure that we get the maximum use of those samples that have been collected. So there's a lot of work that’s going on right now to finalize the plan, then over the coming months, we can complete the analysis and then at that time, we should have a much clear picture. #1, we’ll have more patient follow-ups, so we’ll know how more patients did, then to combine that with the data from the analysis we think can yield some really valuable information.
RJ: ”Now, my I-O question: this is a question about indications in combination with bavituximab. We did see pretty good data with AstraZeneca’s combination with PD-L1 [???] and their own CTLA-4 in mesothelioma and NCSLC. In fact, they do have orphan disease status and fast track with the FDA combining a CTLA-4 and a PD-L1, and these are PD-L1 low expressing tumors. So, extending into the rationale behind bavituximab also showing efficacy in PD-L1/ PD-L1 low tumors, is there a plan, given that data you're looking at, the PD-L1 approaches, and I think that some of the work was done by Scott Antonio, who's also an advisor to Peregrine. Is there a plan to move beyond, just NSCLC in combination with PD-L1 and in other PD-L1 low expressing tumors?”
Steve King: Absolutely, that’s really part & parcel of what we think we can do through all of our collaborators, AstraZeneca, the NCCN, Sloan Kettering, and UTSW, is to look at other indications. We’ve generated some interesting data earlier in liver cancer and other solid tumor types, so the opportunity to go into some of those indications where there is still clearly a high unmet medical need and patients not responding as well as everyone would like to the immuno therapy. So, we see a lot of opportunity in multiple indications outside of lung cancer, because we also recognize that lung cancer is becoming a crowded space and as you put more & more drug and drug combinations into the system, where is that an approvable indication? Now, the one benefit we think we will have in a durva, or any other PD-1/PD-L1 inhibitor, combination with bavi, is potentially on the safety side, and that really could pay dividends, because you can keep patients on treatment longer and you may be able to enhance that activity even further. So, that’s some of the things that we want to explore. First & foremost, which patients are going to respond the best, and then it's which indications or which tumor types we think then there's areas of opportunity. We want to simultaneously approach those 2 questions, and piece it together through small studies, generate good data, and then really expand it out from there - that really creates our value opportunity. The CTLA-4 + durva results are very good, but as with all of the other CTLA-4 combos of PD-1/PD-L1 inhibitors, there are significant toxicities and we think that’s where there could be an opportunity in the marketplace for safer combinations that have at least the same or maybe even greater activity.
RJ: ”Are there discussions in conjunction with AstraZeneca, or others, to address other tumors that are PD-L1 low, where conventional checkpoint inhibitors don’t work, or is this just an inate Peregrine-driven effort?”
Steve King: There is definitely the interest, clearly, in some of the other tumor types that haven’t historically responded as well to the I-O agents; breast cancer for instance, but there are other examples where we think bavi does have activity, and we want to see if we can take advantage of that from a 'priming the system', if you will, to be able to keep that immune response going with the PD-1/PD-L1 inhibitors. Yes, that’s definitely a big topic of interest is how do we, not just continue to add on and add on in lung cancer, but how do we actually get more and more tumor types to respond, and we think we can have a good role there and that’s one of the things we want to explore, either through the AZ basket study or even through some of the other collaborations we have ongoing.
5. Joe Pantginis FOLLOWUP – Roth Capital Partners: [ http://www.roth.com ]
JP: ”To George’s earlier question, how much bavi you have in your stores right now? And what’s the shelf life?”
Steve King: I don’t think we have any public information there, but we have more than enough in supply to basically be able to run all the studies we are talking about through NCCN or with our other collaborator, AZ. So drug supply will not be an issue, which is good because that offers us more capacity for the clients over in the Myford facility. So, that’s all positive at this point. With regard to the shelf life, our goal, as with any commercial product, is multiple years of stability in the bulk stage and then multiple years in the final vial, so, you end up with a lot of shelf life at the end of the day. That's helpful now, and it’s very helpful once you get to the commercial phase.
JP: ”Can you just remind us with regard to the current terms if you will with AstraZeneca, are they supplying durvalumab free of charge?”
Steve King: Yes, they are.
6. Joseph Tascalusia (sp???)
”This is a follow-up to Mr. Pantginis’ question. Is there a plan in place to possibly restructure expenses to more closely align with the Avid revenues, because it would suddenly appear with the stock price at $.40 that the ATM is no longer a viable option?”
Steve King: We are looking at the overall program. #1, we want to continue to grow revenues on the Avid side of the business. So that’s good, more money that’s coming in. On the expense side of things, we’ve already put on hold the other chemotherapy combination studies which were planned to be a significant part of our go-forward strategy, and still may be in the future, we need just more data from the SUNRISE study and then we can reevaluate. But, in the mean time, the concept is we want to be very efficient; the collaborations such as NCCN are very efficient from a cash utilization standpoint. The types of studies we run with AZ, we want to really gear those toward answering specific questions, maybe in a smaller format, which does 2 things: one it allows us to quickly generate data, but then to grow those studies, if you will, based on positive results, and positive results are going to have an impact on the market perception of the drug and what our value is. And so, we want to really take a step-wise approach, but I think we can generate good positive data without running huge hundreds and hundreds of patient studies, but really go through small studies, build on success and then use that as a springboard to even bigger studies with the idea being that, at that point, partners can jump in to help us run those studies. I think the market will respond to positive data in showing that we have good potential with the PD-1/PD-L1 inhibitor-class of drugs.
MR. KING’S CLOSING COMMENTS:
Okay, I’d like to thank again all of you 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 patients, their families and the investigators that are participating in our bavituximab clinical trials. With that, we will conclude the call.
= = = = = = = = = = = = = = = = = = = = = = = = = = = = = == = = =
12-10-15 PR: ”Peregrine Pharmaceuticals Reports Financial Results for 3rd Qtr of FY 2016 and Recent Developments”
--Company Focused on Advancing Its Bavituximab Immuno-Oncology Program Through Its Pharmaceutical, Academic and Clinical Collaborations
--Full FY 2016 Revenue From Biomanufacturing Business, Avid Bioservices, Expected to Top $40 Million
--New State-of-the-Art Production Facility Commissioned and Ready for GMP Manufacturing Expands Revenue Potential
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=959623
TUSTIN, March 9, 2016: Peregrine Pharmaceuticals, Inc. (PPHM) (PPHMP), a biopharmaceutical company focused on developing therapeutics to stimulate the body's immune system to fight cancer, today announced financial results for the third quarter of fiscal year (FY) 2016 ended January 31, 2016, and provided an update on its advancing clinical pipeline and other corporate developments.
HIGHLIGHTS SINCE OCTOBER 31, 2015
“Earlier this week, we announced the commissioning of our new commercial biomanufacturing facility, which gives us significant revenue growth potential over the short term. This represented a key corporate milestone and we are continuing to evaluate a number of additional opportunities to further expand this important, revenue-generating business,” stated Steven W. King, President and CEO of Peregrine. “On the drug development side, we unfortunately experienced a recent setback with the early discontinuation of our SUNRISE Phase III study evaluating the combination of bavituximab and chemotherapy. While we continue to collect patient follow-up data in the SUNRISE study and work to better understand the final trial outcome, we have made the decision to put a hold on our other chemotherapy combination trials so that we can make an informed decision on how to potentially proceed.”
Mr. King continued, “In the meantime, we remain enthusiastic about the potential of combining bavituximab with other immuno-oncology (“I-O”) agents based on a significant amount of translational and preclinical data demonstrating that bavituximab has the potential to enhance the activity of checkpoint inhibitors. These I-O combinations are based on completely different mechanistic synergies than the chemotherapy combinations and the interest in pursuing this development pathway remains high. We are in the process of engaging all of our collaborators to formulate a comprehensive clinical strategy for exploring the potential of bavituximab with immune checkpoint inhibitors, such as PD-L1 and PD-1 inhibitors. The overall goal of these efforts is to generate important clinical data that will guide the program toward the specific patient populations that can realize the biggest benefit from these I-O combination treatments.”
CLINICAL DEVELOPMENT HIGHLIGHTS
Peregrine is working closely with its collaborators and key opinion leaders (“KOLs”) to transition the company’s clinical program to focus on bavituximab combinations with I-O agents. Peregrine’s partners and advisors, including AstraZeneca, Memorial Sloan Kettering Cancer Center, the National Comprehensive Cancer Network (NCCN) and the University of Texas, Southwestern, are leaders in the field of immuno-oncology, and their collective guidance will play an important role in the program. Activities in this area include:
Peregrine and AstraZeneca are currently evaluating the trial designs for the two previously announced clinical trials combining bavituximab with AstraZeneca’s PD-L1 inhibitor, durvalumab. In light of the recent development in the SUNRISE trial, the companies are currently working together to identify the optimal path forward for demonstrating potential mechanistic synergies between bavituximab and durvalumab in different patient populations. The expected timing of initiation of any trial will be determined upon finalization of its trial design.
Peregrine entered into a new research collaboration with the NCCN to expand upon the company's clinical development program of bavituximab in combination with immuno-oncology agents for the treatment of a range of tumors. NCCN is a not-for-profit alliance of 26 of the world's leading cancer centers dedicated to improving the quality, effectiveness, and efficiency of cancer care. Peregrine will fund multiple investigator-initiated clinical and correlative studies with bavituximab in multiple cancers at NCCN Member Institutions and their affiliate community hospitals through a $2 million research grant to NCCN's Oncology Research Program (ORP). NCCN will be responsible for oversight and monitoring of the clinical studies through the research grant.
SUPPORTIVE RESEARCH HIGHLIGHTS
Positive results were presented at the 2015 annual meeting of the Society for Immunotherapy of Cancer (SITC) from multiple new preclinical studies demonstrating enhanced anti-tumor activity and immune activation for combinations of a preclinical bavituximab equivalent and checkpoint inhibitors such as anti-PD-1 and anti-CTLA-4 in preclinical models of breast cancer and melanoma. Additionally, the company announced preliminary results for a new clinical test specifically designed to illustrate how bavituximab modulates immune responses in the tumor microenvironment.
AVID BIOSERVICES HIGHLIGHTS
“The Avid business grew 20% in FY 2015 to $26.7 million in revenue, and is expected to top $40 million in revenue for the current FY ending April 30, 2016,” stated Paul Lytle, CFO of Peregrine. “Our new state-of-the-art, 40,000 square foot commercial biomanufacturing facility, which was recently formally commissioned, is outfitted with cutting-edge, single-use equipment to accommodate a fully disposable biomanufacturing process for late Phase III clinical and commercial production of biologics. Demand for this new production capacity is high and we already have manufacturing commitments for products to be delivered in FY 2017. With demand expected to grow, we are actively considering options for potentially adding more production capacity to support additional growth of this business.”
Avid’s new state-of-the-art commercial biomanufacturing suite has been formally commissioned. The new facility will double the company’s prior manufacturing capacity, supporting up to an additional $40 million in revenue each year. As of February 1, 2016, Avid Bioservices had a revenue backlog in excess of $58 million under committed contracts from existing clients, covering services to be completed in the fourth quarter of FY 2016 and into FY 2017.
FINANCIAL RESULTS
Total revenues for the third quarter of FY 2016 were $6,709,000, compared to $5,677,000 for the same quarter of the prior fiscal year. The increase was attributed to an increase in contract manufacturing revenue generated from Avid Bioservices. Contract manufacturing revenue from Avid's clinical and commercial biomanufacturing services provided to its third-party clients for the third quarter FY 2016 were $6,672,000, compared to $5,677,000 for the same quarter of the prior FY. Peregrine expects third-party contract manufacturing revenue for the entire FY to exceed $40 million. In addition to providing biomanufacturing services to its third-party clients, Avid will continue to support the clinical manufacturing of bavituximab.
Total costs and expenses in the third quarter of FY 2016 were $23,576,000, compared to $18,699,000 in the third quarter of FY 2015. This increase was primarily attributable to current quarter increases in research and development expenses associated with the increase in manufacturing costs associated with bavituximab, the planned Phase II immuno-oncology combination trial of bavituximab and durvalumab in NSCLC, the Phase II chemotherapy combination trial in breast cancer that was initiated in December 2015 and recently placed on hold, and an increase in the cost of contract manufacturing associated with higher reported revenue. For the third quarter of FY 2016, research and development expenses were $15,156,000, compared to $11,261,000 for the third quarter of FY 2015. For the third quarter of FY 2016, cost of contract manufacturing was $3,896,000, compared to $3,113,000 for the third quarter of FY 2015. Selling, general and administrative expenses were $4,524,000 for the third quarter of FY 2016 compared to the $4,325,000 for the third quarter of FY 2015.
Peregrine's consolidated net loss attributable to common stockholders was $18,227,000, or $.08 per share [Op-Burn: 15,086,000 - see 10-Q p.27], for the 3rd quarter of FY 2016, compared to a net loss attributable to common stockholders of $14,027,000, or $0.08 per share, for the same prior year quarter.
Peregrine reported $67,470,000 in cash and cash equivalents as of January 31, 2016 compared to $68,001,000 at fiscal year ended April 30, 2015.
More detailed financial information and analysis may be found in Peregrine's Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today. [ http://tinyurl.com/hdgto9y ]
CONFERENCE CALL
Peregrine will host a conference call and webcast this morning, March 9, 2016, at 11:30AM ET (8:30AM 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 developing therapeutics to stimulate the body's immune system to fight cancer. The company is focused on evaluating its lead immunotherapy candidate, bavituximab, in combination with a range of novel immuno-oncology (I-O) agents for the treatment of various cancers. In addition to its drug development programs, Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com ), which provides development and biomanufacturing services for both Peregrine and third-party customers. For more information, please visit http://www.peregrineinc.com .
ABOUT AVID BIOSERVICES
Avid Bioservices provides a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With over 15 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, Avid's services include cGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support. The company also provides a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. For more information about Avid, please visit http://www.avidbio.com .
Safe Harbor *snip*
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
THREE MONTHS ENDED NINE MONTHS ENDED
JANUARY 31, JANUARY 31,
2016 2015 2016 2015
REVENUES:
Contract manufacturing revenue $ 6,672,000 $ 5,677,000 $ 25,574,000 $ 17,436,000
License revenue 37,000 - 329,000 37,000
Total revenues 6,709,000 5,677,000 25,903,000 17,473,000
COSTS AND EXPENSES:
Cost of contract manufacturing 3,896,000 3,113,000 13,245,000 10,835,000
Research and development 15,156,000 11,261,000 43,264,000 31,465,000
Selling, general and administrative 4,524,000 4,325,000 13,839,000 13,503,000
Total costs and expenses 23,576,000 18,699,000 70,348,000 55,803,000
LOSS FROM OPERATIONS (16,867,000 ) (13,022,000 ) (44,445,000 ) (38,330,000 )
OTHER INCOME (EXPENSE):
Interest and other income 34,000 29,000 691,000 108,000
Interest and other expense (14,000 ) (1,000 ) (14,000 ) (1,000 )
Total other income (expense), net 20,000 28,000 677,000 107,000
NET LOSS $ (16,847,000 ) $ (12,994,000 ) $ (43,768,000 ) $ (38,223,000 )
COMPREHENSIVE LOSS $ (16,847,000 ) $ (12,994,000 ) $ (43,768,000 ) $ (38,223,000 )
Series E preferred stock accumulated dividends (1,380,000 ) (1,033,000 ) (3,448,000 ) (2,577,000 )
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS $ (18,227,000 ) $ (14,027,000 ) $ (47,216,000 ) $ (40,800,000 )
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:
Basic and Diluted 227,389,225 182,519,923 209,549,670 180,562,524
BASIC AND DILUTED LOSS PER COMMON SHARE $ (0.08 ) $ (0.08 ) $ (0.23 ) $ (0.23 )
PEREGRINE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
JANUARY 31,
2016 APRIL 30,
2015
Unaudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 67,470,000 $ 68,001,000
Trade and other receivables, net 8,599,000 3,813,000
Inventories 15,189,000 7,354,000
Prepaid expenses and other current assets, net 2,346,000 1,355,000
Total current assets 93,604,000 80,523,000
Property and equipment, net 23,846,000 15,124,000
Other assets 1,602,000 1,817,000
TOTAL ASSETS $ 119,052,000 $ 97,464,000
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable $ 7,844,000 $ 10,385,000
Accrued clinical trial and related fees 6,975,000 3,910,000
Accrued payroll and related costs 4,497,000 4,606,000
Deferred revenue 15,418,000 6,630,000
Customer deposits 22,433,000 11,363,000
Other current liabilities 1,047,000 437,000
Total current liabilities 58,214,000 37,331,000
Deferred rent, less current portion 905,000 1,098,000
Commitments and contingencies
STOCKHOLDERS’ EQUITY:
Preferred stock – $0.001 par value; authorized 5,000,000 shares; 1,577,440 and 1,574,764 shares issued and outstanding at January 31, 2016 and April 30, 2015, respectively 2,000 2,000
Common stock – $0.001 par value; authorized 500,000,000 shares; 232,231,242 and 193,346,627 shares issued and outstanding at January 31, 2016 and April 30, 2015, respectively 232,000 193,000
Additional paid-in capital 557,091,000 512,464,000
Accumulated deficit (497,392,000 ) (453,624,000 )
Total stockholders’ equity 59,933,000 59,035,000
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 119,052,000 $ 97,464,000
CONTACTS:
• Jay Carlson Peregrine Pharmaceuticals, Inc. 800-987-8256 info@peregrineinc.com
• Stephanie Diaz (Investors) Vida Strategic Partners 415-675-7401 sdiaz@vidasp.com
• Tim Brons (Media) Vida Strategic Partners 415-675-7402 tbrons@vidasp.com
- - - - - - - - -
[ From 10-Q header: “As of Mar. 8 2016, there were 233,738,426 shares outstanding.”
- - - - - - - - - - - - - - - - -
Latest 10K 4-30-15 iss. 7-14-15 http://tinyurl.com/ocrtkuj PR: http://tinyurl.com/nw2v5u6 (Cash 4-30-15=$68.0mm)
Latest 10Q 1-31-16 iss. 3-9-16 http://tinyurl.com/hdgto9y PR: http://tinyurl.com/gom7md5 (Cash 1-31-16=$67.5mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
.
= = = = = = = = = = = = = = = = = = = = = = = = = = = =
Updated PPHM REVS-BY-QTR TABLE, now thru FY16'Q3(qe 1-31-16), per the 1-31-16 10-Q ( http://tinyurl.com/hdgto9y ) issued 3-9-16.
• Total Revs since May’06: ($154.8mm/Avid + $24.1mm/Govt + $2.5mm/Lic.) = $181.4mm
• 3-9-16: FY'16 (May'15-Apr'16) Avid revs guidance raised from $35-40mm to “over $40mm”.
• Deferred-Revs at 1-31-16 total $15.4mm, UP from $9.7mm at 10-31-15.
• Cust.Deposits at 1-31-16 total $22.4mm, UP from $14.9mm at 10-31-15.
• Inventories at 1-31-16 total $15.2mm, UP from $12.6mm at 10-31-15.
• Avid’s Gross-Profit over last 3 qtrs: $12.3mm on revs of $25.6mm (GP%=48%)
• Recall, Avid Rev$ from Gov’t DTRA Contract work (6/30/08 – 4/15/11, totaling $24.15mm), went into GOVT-REVS, not AVID-REVS, in the Financials.
Avid’s website: http://www.avidbio.com
AVID PROFITABILITY (GROSS*) BY QTR:
QTR Avid-Rev$ CostofMfg$ Gross-Profit$ GP%
FY13Q1 7-31-12 4,135,000 2,024,000 2,111,000 51%
FY13Q2 10-31-12 6,061,000 3,703,000 2,358,000 39%
FY13Q3 1-31-13 6,961,000 3,651,000 3,310,000 47%
FY13Q4 4-30-13 4,176,000 3,217,000 959,000 23%
FY14Q1 7-31-13 4,581,000 2,670,000 1,911,000 42%
FY14Q2 10-31-13 7,354,000 4,195,000 3,159,000 43%
FY14Q3 1-31-14 3,885,000 2,416,000 1,469,000 38%
FY14Q4 4-30-14 6,474,000 3,829,000 2,645,000 41%
FY15Q1 7-31-14 5,496,000 3,583,000 1,913,000 35%
FY15Q2 10-31-14 6,263,000 4,139,000 2,124,000 34%
FY15Q3 1-31-15 5,677,000 3,113,000 2,564,000 45%
FY15Q4 4-30-15 9,308,000 4,758,000 4,550,000 49%
FY16Q1 7-31-15 9,379,000 4,608,000 4,771,000 51%
FY16Q2 10-31-15 9,523,000 4,741,000 4,782,000 50%
FY16Q3 1-31-16 6,672,000 3,896,000 2,776,000 42%
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%*
*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
Totals: 154786 24149 2453 181388 <=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
...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
= = = = = = = =
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)
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
Q/E Halozyme Cust-A/U.S. Other-Custs
4-30-14 91% 1% 8%
4-30-15 79% 12% 9%
7-31-15 84% 15% 1%
10-31-15 56% 41% 3%
1-31-16 64% 27% 9%
ATM Sales Summary (3/2009–3/8/2016). Also, PPHM O/S Shares History Table (’06–curr.) at the bottom of this post…
At 3-8-16, shares O/S = 233,738,426
ATM = “At-The-Market Sales Issuance”
I. WM-SMITH 3-2009:
• $7.5mm ATM/Wm.SMITH 3-26-09: $7,500,000gr. / 2,150,759sh. = $3.49/sh. (commiss: 3%)
• $25mm ATM/Wm.SMITH 7-14-09: $25,000,000gr. / 7,569,314sh. = $3.30/sh. (commiss: 3%/1st$15mm, then 2%)
*Total Raised via WmSmith ATM Sales thru 7-31-10:
. . . . $32,500,000gr. / 9,720,073sh. = $3.34/sh.
II. MLV 6-2010: http://www.mlvco.com
$15mm ATM/MLV 6-22-10 (commiss: 2%) Form424: http://tinyurl.com/24txkxb
• Sold 6/22/10–10/31/10: $6,840,000gr. / 4,031,018sh. = $1.70/sh.
• Sold 11/1/10–11/30/10: $7,407,000gr. / 4,711,611sh. = $1.57/sh.
• Sold 12/1/10–1/31/11: $753,000gr. / 471,744sh. = $1.60/sh.
*Total Raised via MLV June’10 ATM Sales thru 1-31-11:
. . . . $15,000,000gr. / 9,214,373 = $1.63/sh.
III. MLV 12-2010: “Dec’10 AMI Agreement” http://www.mlvco.com
$75mm ATM/MLV 12-29-10 (commiss: max=5%) Form8K: http://tinyurl.com/2a6w76g
(pursuant to $75mm S-3 Shelf Reg. filed 12-17-10: http://tinyurl.com/2469b2d )
• Sold 12/29/10-1/31/11: $6,460,000gr. / 2,385,862sh. = $2.71/sh.
• Sold 2/1/11-2/28/11: $2,358,000gr. / 998,142sh. = $2.36/sh.
• Sold 3/1/11-4/30/11: $4,470,000gr. / 1,840,487sh. = $2.43/sh.
• Sold 5/1/11-7/31/11: $3,713,000gr. / 1,912,576sh. = $1.94/sh.
• Sold 8/1/11-10/31/11: $5,582,000gr. / 4,727,840sh. = $1.18/sh.
• Sold 9-2-12 Roth Direct: $6,940,000gr./ 6,252,252sh. = $1.11/sh.
• Sold 11/1/11-1/31/12: $10,961,000gr. / 10,308,025sh. = $1.06/sh.
• Sold 2/1/12-2/29/12: $5,871,000gr. / 5,726,946sh. = $1.03/sh.
• Sold 3/1/12-4/30/12: $1,263,000gr. / 2,198,543sh. = $.57/sh.
• Sold 5/1/12-6/30/12: $1,496,000gr. / 2,752,691sh. = $.54/sh.
• Sold 7/1/12-9/26/12: none**
• Sold 9/27/12-10/31/12: $16,719,000gr./ 18,557,928 = $.90/sh.
• Sold 11/1/12-11/30/12: $7,296,000gr./ 9,220,313 = $.79
• Sold 12/1/12-1/31/13: $1,540,000gr./ 1,131,282 = $1.36
• Sold 2/1/13-3/12/13: $330,000gr./ 201,154 = $1.64
*Total Raised via MLV Dec’10 ATM Sales thru 3-12-2013:
. . . . $75,000,000gr. / 68,214,041 = $1.10sh.
IV. MLV 12-2012: “Dec’12 AMI Agreement” http://www.mlvco.com
$75mm ATM/MLV 12-29-12 (commiss: max=5%) Form8K: http://tinyurl.com/2a6w76g
(pursuant to $75mm S-3 Shelf Reg. filed 3-9-12: http://tinyurl.com/7dl7pjm )
• Sold 2/1/13-3/12/13: $4,475,000gr. / 3,132,402sh. = $1.43/sh.
• Sold 3/13/13-4/30/13: $8,897,000gr. / 6,188,273sh. = $1.44/sh.
• Sold 5/1/13-7/11/13: $12,729,000gr. / 7,927,016sh. = $1.61/sh.
• Sold 7/12/13-7/31/13: $2,468,000gr. / 1,690,864sh. = $1.46/sh.
• Sold 8/1/13-9/9/13: $4,372,000gr. / 3,057,431sh. = $1.43/sh.
• Sold 9/10/13-10/31/13: $4,708,000gr. / 3,262,958sh. = $1.44/sh.
• Sold 11/1/13-12/6/13: NONE – see 10Q note below.
• Sold 12/7/13-1/31/14: $28,130,000gr. / 16,045,717sh. = $1.75/sh.
• Sold 2/1/14-4/30/14: $3,017,000gr. / 1,543,383sh. = $1.95/sh.
• Sold 5/1/14-7/31/14: $425,000gr. / 226,700sh. = $1.92/sh.
• Sold 8/1/14-10/31/14: $3,891,000gr. / 2,494,835sh. = $1.56/sh.
• Sold 11/1/14-1/31/15: $1,878,000gr. / 1,261,825sh. = $1.49/sh.
*Total Raised via MLV Dec’12 ATM Sales thru 10-31-2014:
. . . . $75,000,000gr. / 46,831,404 = $1.60sh.
V. MLV 6-2014: “Jun’14 AMI Agreement – up to $25mm” http://www.mlvco.com
• Sold 11/1/14-1/31/15: $1,193,000gr. / 869,504sh. = $1.43/sh.
• Sold 2/1/15-3/12/15: $6,204,000gr. / 4,354,954sh. = $1.44/sh.
• Sold 3/13/15-4/30/15: $6,147,000gr. / 4,457,299sh. = $1.38/sh.
• Sold 5/1/15-7/14/15: $8,896,000gr. / 6,534,400sh. = $1.36/sh.
• Sold 7/15/15-7/31/15: $1,270,000gr. / 1,003,830sh. = $1.27/sh.
• Sold 8/1/15-9/9/15: $1,290,000gr. / 1,091,508sh. = $1.18/sh.
*Total Raised via MLV Jun’14 ATM Sales thru 9-9-2015:
. . . . $25,000,000gr. / 18,311,495 = $1.37/sh.
VI. MLV 8-2015: “Aug’15 AMI Agreement – up to $30mm” http://www.mlvco.com
• Sold 8/7/15-9/9/15: $892,000gr. / 1,091,000sh. = $1.18/sh.
• Sold 9/10/15-10/31/15: $4,294,000gr. / 4,059,478sh. = $1.06/sh.
• Sold 11/1/15-12/10/15: $2,261,000gr. / 1,939,413sh. = $1.17/sh.
• Sold 12/11/15-1/31/16: **NO ATM SALES, per 1-31-16 10Q iss. 3-9-16**
. . . . $7,447,000gr. / 6,751,651 = $1.10/sh.
VII. NOBLE 8-2015: “Aug’15 Eq.Dist. Agreement – up to $20mm” http://www.noblelsp.com
• Sold 11/1/15-12/10/16: $2,371,000gr. / 1,925,844sh. = $1.23/sh.
• Sold 12/11/15-1/31/16: $2,857,000gr. / 2,529,434sh. = $1.13/sh.
. . . . $5,228,000gr. / 4,455,278 = $1.17/sh. '
TOTAL ALL A-T-M SALES – INCEPTION (3-2009) THRU 9-9-2015:
==> $235,175,000gr. / 163,498,315sh. = $1.44/sh.
- - - - - - - - - -
10-31-11 10Q: “During the 6mos. 10-31-11, we sold 6,440,416 shares of our common stock at mkt-prices for gross proceeds of $9,295,000 under the Dec’10 AMI Agreement before deducting commissions and other issuance costs of $260,000”
1-31-12 10Q: “During the 9mos. ended 1-31-12, we sold 16,948,441 shares of our common stock at mkt-prices for gross proceeds of $20,256,000 under the Dec’10 AMI Agreement before deducting commissions and other issuance costs of $482,000. …During Feb.2012, we sold an addl. 5,726,946 shares of common stock at market prices under the Dec’10 AMI Agreement in exchange for aggregate gross proceeds of $5,871,000. As of 2-29-12, gross proceeds of $38,644,000 remained available under our 2 effective shelf registration statements.”
4-30-12 10K: “Under the Dec. 2010 AMI Agreement with MLV …for aggregate gross proceeds of up to $75,000,000… During FY’s 2011 (5’10-4’11) and 2012 (5’11-4’12), we sold 30,098,421 shares of common stock at market prices under the Dec.2010 AMI for aggregate gross proceeds of $40,678,000 before deducting commissions & other issuance costs of $917,000. As of April 30, 2012, aggregate gross proceeds of up to $27,382,000 remained available under the Dec.2010 AMI… Subsequent to April 30, 2012 and through June 30, 2012, we sold 2,752,691 shares of common stock at mkt prices under the Dec.2010 AMI for aggregate gross proceeds of $1,496,000… Under the registered direct public offering dated Sept. 2, 2011, we entered into separate subscription agreements with 3 institutional investors, pursuant to which we sold an aggregate of 6,252,252 shares of our common stock at a purchase price of $1.11/sh. for gross proceeds of $6,940,000 before deducting placement agent fees and other offering expenses of $525,000.”
10-31-12 10Q: “During the 6mos. 10-31-12, we sold 21,310,619 shares… at varying mkt-prices under the Dec’10 AMI Agreement for gross proceeds of $18,215,000 before deducting commissions and other issuance costs of $620,000. From 11-1-12 thru 11-30-12, we sold 9,220,313 shares gross of $7,296,000. As of 11-30-12, aggregate gross proceeds of up to $1,871,000 remained available under the Dec’10 AMI Agreement. As of 11-30-12, gross proceeds of $151,871,000 remained available under 2 effective shelf registration statements.”
1-31-13 10Q/pg.11: “DEC’10-AMI(max=$75mm): During the 9 mos. ended 1-31-13, we sold 31,662,214 shares at varying mkt-prices for gross proceeds of $27,051,000 before deducting commissions/other-costs of $885,000. As of 1-31-13, gross proceeds of up to $330,000 remained available. From 2-1-13 – 3-12-13, we sold 201,154 shares at mkt prices for gross $330,000. As of 3-12-13, we had raised the full amt of gross proceeds available… DEC’12-AMI(max=$75mm): As of 1-31-13, we had not sold any shares. From 2-1-13 - 3-12-13, we sold 3,132,402 shares at mkt prices for gross proceeds of $4,475,000. As of 3-12-13, gross proceeds of up to $70,525,000 remained available.”
4-30-13 10K/pg.F26: Dec’12-AMI(max=$75mm)Agreement – During FY’13, we sold 9,320,675 shares gross proceeds of $13,372,000 before deducting commissions and other issuance costs of $337,000. As of April 30, 2013, gross proceeds of up to $61,628,000 remained available under the Dec’12-AMI. From 5/1/13 – 7/11/13, we sold 7,927,016 shares for gross proceeds of $12,729,000. As of 7-11-13, gross proceeds of $48,899,000 remained available under the Dec’12-AMI. http://tinyurl.com/p58jcbw
7-31-13 10Q/pg.10: During the 3mos ended 7-31-13, we sold 9,617,880 shares at mkt prices under the Dec’12 AMI Agreement for gross proceeds of $15,197,000 before deducting commissions and other issuance costs of $491,000. As of July 31, 2013, gross proceeds of up to $46,431,000 remained available under the Dec’12-AMI. From 8-1-13 – 9-9-13, we sold 3,057,431 shares for gross proceeds of $4,372,000. As of 9-9-13, gross proceeds of $42,059,000 remained available under the Dec’12-AMI.
10-31-13 10Q/pg.10: During the 6mos ended 10-31-13, we sold 15,938,269 at mkt prices under the Dec’12 AMI for gross proceeds of $24,277,000 before deducting costs of $722,000. As of 10-31-13, aggregate gross proceeds of up to $37,351,000 remained available under the Dec’12 AMI.
***NOTE: There is no stmt in the 10-Q regarding AMI Sales subsequent to 10-31-13 (thru 12-6-13) as has been the case in the 10Q’s for years – the assumption being: NO AMI Sales made 11/1/13-12/6/13, a period where O/S shares only went up by 77,149.
1-31-14 10Q/pg.11: During the 9 mos. ended 1-31-14, we sold 31,983,986 shares under the Dec’12/AMI for gross $52,407,000 before deducting commissions & other iss. costs of $1,427,000. As of 1-31-14, gross proceeds of up to $9,221,000 remained available under the Dec’12/AMI. http://tinyurl.com/pxcjocw
4-30-14 10K pg.F25: “During FY14, we sold 33,527,369 shares under the Dec’12/AMI for gross proceeds of $55,424,000 before deducting commissions & other iss. costs of $1,504,000. As of April 30, 2014, aggregate gross proceeds of up to $6,204,000 remained available under the December 2012 AMI Agreement.” http://tinyurl.com/mhva3k3
7-31-14 10Q/Pg5: During the 3mos. ended 7-31-14, we raised $10,000,000 in aggregate gross proceeds from the sale of our 10.50% SeriesE Convertible Preferred Stock under an At Market Issuance Sales Agreement. Pg.11: During the 3mos. ended 7-31-14, we sold 226,700sh. under the Dec’12-2012 AMI Agreement for gross of $435,000 before deducting commissions & other costs of $14,000. As of 7-31-14, gross of up to $5,769,000 remained available under the Dec’12-2012/AMI. On 6-13-14, we entered into an At Market Issuance Sales Agreement (“June2014/AMI”), with MLV, pursuant to which we may sell shares of our common stock through MLV, for aggregate gross proceeds of up to $25,000,000, in registered transactions from our shelf registration statement on Form S-3. As of 7-31-14, we had not sold any shares of common stock under the June 2014 AMI Agreement. http://tinyurl.com/phw6dkp
10-31-14 10Q/Pg12: COMMON: During 6mos. ended 10-31-14, we sold 2,721,535 sh. at mkt prices under the Dec’12-AMI for gross proceeds of $4,326,000 before deducting commissions and other issuance costs of $113,000. As of 12-31-14, gross proceeds of up to $1,878,000 remained available under the Dec’12-AMI. PREFERRED: During 6mos. ended 10-31-14, we sold 402,858 sh. at mkt prices gross proceeds of $10,070,000 before deducting commission and other issuance costs of $552,000. As of 10-31-14, gross proceeds of up to $19,930,000 remained available under the Series E AMI Agreement. http://tinyurl.com/m6ldhg7
1-31-15 10Q/Pg12: COMMON: During the 9mos. ended 1-31-15, we sold 3,983,360 sh. at mkt prices under the Dec’12-AMI for gross proceeds of $6,204,000 before deducting commissions and other issuance costs of $162,000. As of 1-31-15, we had raised the full-amt of gross proceeds available to us under the Dec’12-AMI. PREFERRED:
Jun’14-AMI: On 6-13-14, we entered into an AMI with MLV…up to $25mm… ,000,000, in registered transactions from our shelf registration statement on Form S-3 (File No. 333-180028). During the 9mos. ended 1-31-15, we sold 869,504 sh. at mkt prices under the Jun’14-AMI for gross of $1,193,000 before deducting commissions and other issuance costs of $31,000. As of 1-31-15, gross proceeds of up to $23,807,000 remained available. Subsequent to 1-15-15 and thru 3-12-15, we sold 4,354,954 sh. of common at mkt prices under the Jun’14-AMI for gross of $6,204,000. As of 3-12-15, 2015, gross proceeds of $17,603,000 remained available under the Jun’14-AMI.
PREFERRED: During the 9mos. ended 1-31-15, we sold 405,004 sh. of our Series E Preferred Stock at mkt prices under the Series E AMI Agreement for gross proceeds of $10,121,000 before deducting commission and other issuance costs of $553,000. As of 1-31-15, 2015, gross proceeds of up to $19,879,000 remained available under the Series E AMI. http://tinyurl.com/mwedt8w
4-30-15 10K pg.F25: During FY’15 we sold 9,681,757sh. under the June’14/AMI for $13,544,000, before deducting costs of $352,000. As of 4-30-15, $11,456,000 remained available. Pg.F35: Subsequent to 4-30-15 & thru 7-14-15, we sold 6,534,400sh. for $8,896,000. A/o 7-14-15, $2,560,000 remain. http://tinyurl.com/ocrtkuj
7-31-15 10Q/Pg12+18: During the 3mos ended 7-31-15, we sold 7,538,230sh. Under the JUNE2014 AMI for gross of $10,166,000 before deducting commiss/iss-costs of $275,000. As of 7-31-15, gross of $1,290,000 remained available under the JUNE2014 AMI, as amended. JUNE2014 AMI: subsequent to 7-31-15 and thru 9-9-15, we sold 1,091,508sh. gross of $1,290,000. As of 9-9-15, 2015, we had raised the full amount available under the June2014 AMI. AUG2015 AMI: on 8-7-15, we entered into an At Market Issuance Sales Agreement with MLV, for gross proceeds of up to $30,000,000, 2.5% commission; as of 9-9-15, we sold 752,760sh. under the AUG2015 AMI for gross of $892,000. http://tinyurl.com/pemub47
10-31-15 10Q/Pg13+19: During 6mos ended 10-31-15, we sold 4,812,238sh at mkt prices under MLV AUG2015 AMI for gross=$5,186,000 before deducting commiss/costs of $132,000. As of 10-31-15, gross proceeds of up to $24,814,000 remained available. Subsequent to 10-31-15, thru 12-10-15, we sold 1,939,413sh for gross=$2,261,000. As of 12-10-15, $22,553,000 remained.
On 8-7-15, we entered into an “Equity Distribution Agreement” with Noble Life Science Partners, pursuant to which we may sell shares for gross proceeds of up to $20,000,000 (commission=2.5% of gross). As of 10-31-15, we had not sold any shares… Subsequent to 10-31-15 & thru 12-10-15, we sold 1,925,844 shs. at mkt prices for gross=$2,371,000. As of 12-10-15, gross of up to $17,629,000 remained available.
On 10-30-15, we entered into a Common Stock Pur. Agreement with EASTERN CAPITAL Ltd: sold 18,518,518shs @1.08/sh for gross=$20,000,000 before deducting issuance costs of $1,000.
10Q: http://tinyurl.com/zdbo9rv [10-30-15: Kenneth Dart (Eastern Capital) acquires 13.1% stake (30,106,945sh.) in PPHM http://tinyurl.com/24qctos ]
1-31-16 10Q/Pg13: During 9mos ended 1-31-16, we sold 6,751,651sh at mkt prices under MLV AUG2015 AMI for gross=$7,447,000 before commiss/costs =$190,000. As of 1-31-16, gross of $22,553,000 remained available. Subsequent to 10-31-15 thru 12-10-15, we sold 1,939,413sh for gross=$2,261,000. As of 12-10-15, $22,553,000 remained.
NOBLE Eq-Dist-AMI: during 9mos. ended 1-31-16, we sold 4,455,278shs. for gross of $5,228,000, commissions=$131,000. As of 1-31-16, $14,772,000 remained…
10Q: http://tinyurl.com/hdgto9y
PREFERRED SHARES:
4-30-15 10K/p.F26: On 6-13-14, we entered into an At Market Issuance Sales Agreement with MLV, pursuant to which we may issue & sell shares of our Series E Preferred Stock through MLV, as agent, for gross proceeds of up to $30,000,000, in registered transactions from our Jan2014 Shelf. During FY’2015, we sold 799,764 shares of our Series E Preferred Stock at mkt prices for gross $19,205,000 before deducting commissions/costs of $1,002,000. As of 4-30-15, gross proceeds of up to $10,795,000 remained available under the Series E AMI Agreement.
NOTE: One of the holders of Preferred is KENNETH DART (EASTERN CAPITAL), who in a 2-13-15 SG14G ( http://tinyurl.com/k4nsfuu ) reported their 240,000sh. Preferred holdings as 2,000,000 common shares (SHARED VOTING POWER: 9,921,760,% OF CLASS REPRESENTED: 5.4%).
“which has a liquidation preference of $25.00/sh. and a conversion price of $3.00/sh.” 2,000,000 / 240,000 = 8.333
- - - - - - - - - - - - - - - - -
Latest 10K 4-30-15 iss. 7-14-15 http://tinyurl.com/ocrtkuj PR: http://tinyurl.com/nw2v5u6 (Cash 4-30-15=$68.0mm)
Latest 10Q 1-31-16 iss. 3-9-16 http://tinyurl.com/hdgto9y PR: http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=959623 (Cash 1-31-16=$67.5mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
- - - - - - - - - - - - - - - - - -
PPHM’S ATM PHILOSOPHY, CFO PAUL LYTLE, 12-9-10 CC:
“Beyond these 2 sources of capital ([Avid & Gov’t], we have raised addl. capital through the equity markets and it’s important to note that over the past 3 years we have sold every share at market prices [“ATM”], without warrants, without discounts. We continue to be active in the investment community and we have had strong interest from institutional investors intrigued by our clinical data, by our multiple trials to evaluate Bavituximab’s broad therapeutic potential, and by the interim survival data we have seen from our novel brain cancer therapy Cotara. Our goal is to maintain a balanced financial approach with multiple sources of capital and to carefully manage our cash burn as we continue to advance these programs.” http://tinyurl.com/24xmcsn
= = = = = = = = = = = = = = = = = =
PPHM - O/S Shares History (’06–curr.)
4-30-06 35,876,438
1-31-07 39,222,440
4-30-07 39,222,440
7-6-07 45,233,123
7-31-07 45,242,123
10-31-07 45,242,123
1-31-08 45,242,123
4-30-08 45,242,123
7-31-08 45,242,123
10-31-08 45,242,123
1-31-09 45,242,123
4-30-09 45,537,711
7-10-09 47,392,883
7-31-09 47,393,783
10-31-09 48,869,563 +1,475,780
1-31-10 50,903,404 +2,033,841
4-30-10 53,094,894 +2,191,490
6-21-10 54,388,917 +1,294,023 (6-22-10 ATM/mlv Form424)
7-9-10 55,069,449 +475,987 (4-30-10 10K iss. 7-14-10)
7-31-10 55,784,955 +715,506
10-31-10 59,220,742 +3,435,787
11-30-10 63,932,353 +4,711,611 (10-31-10 10Q iss. 12-9-10)
12-15-10 64,404,097 +471,744 (12-17-10 S-3: $75M Shelf Reg.)
1-31-11 66,813,419 +2,409,322
2-28-11 67,885,811 +1,072,392 (1-31-11 10Q iss. 3-11-11)
4-30-11 69,837,142 +1,951,331
7-8-11 71,069,858 +1,232,716 (4-30-11 10K iss. 7-14-11)
8-22-11 72,704,647 +1,634,789 (Proxy iss. 8-26-11)
8-31-11 73,284,016 +579,369 (424B5 iss. 9-2-11)
9-8-11 79,536,268 +6,252,252 (Roth Sale to 3 Inst’s @ $1.11/sh.)
10-31-11 82,638,201 +3,101,933
12-9-11 86,788,817 +4,150,616 (10-31-11 10Q iss. 12-12-11)
1-31-12 93,146,226 +6,357,409
2-29-12 98,873,172 +5,726,946 (1-31-12 10Q iss. 3-9-12)
4-30-12 101,421,365 +2,548,193
7-13-12 104,174,056 +2,752,691 (4-30-12 10K iss. 7-16-12)
7-31-12 104,178,431 +4,375 (7-31-12 10Q iss. 9-10-12)
8-16-12 104,191,176 +12,745 (prelim. proxy 14A http://tinyurl.com/c48bvof )
9-7-12 104,191,176 nochg (7-31-12 10Q iss. 9-10-12)
10-31-12 123,310,188 +19,119,012
12-7-12 132,539,783 +9,229,595 (10-31-12 10Q iss. 12-10-12)
1-31-13 133,770,614 +1,230,831
3-12-13 137,110,758 +3,340,144 (1-31-13 10Q iss. 3-12-13)
4-30-13 143,768,946 +6,658,188 (4-30-13 10K iss. 7-11-13)
7-5-13 151,602,765 +7,833,819 (4-30-13 10K iss. 7-11-13)
7-31-13 153,506,811 +1,904,046
9-5-13 156,461,114 +2,954,303 (7-31-13 10K iss. 9-9-13)
10-31-13 160,248,742 +3,781,628
12-6-13 160,325,891 +77,149 (10-31-13 10K iss. 12-10-13)
1-31-14 176,453,261 +16,127,370
3-3-14 176,481,054 +27,793 (1-31-14 10Q iss. 3-7-14)
4-30-14: 178,871,164 +2,390,110
7-7-14: 179,209,458 +338,294 (4-30-14 10-K cover page, iss. 7-14-14)
7-31-14: 179,216,032 +6,574 (7-31-14 10Q iss. 9-9-14)
8-22-14: 179,226,424 +10,392 (8-28-14 Proxy/Def14A)
9-5-14: 179,505,424 +279,000 (7-31-14 10Q iss. 9-9-14)
10-31-14: 182,000,583 +2,495,159 (10-31-14 10Q iss. 12-10-14)
12-5-14: 182,081,234 +80,651 (10-31-14 10Q cover pg., iss. 12-10-14)
12-19-14: 182,081,234 -0- (12-23-14 S-3)
1-31-15: 184,244,698 +2,163,464 (1-31-15 10Q iss. 3-12-15)
3-12-15: 188,332,872 +4,088,174 (1-31-15 10Q iss. 3-12-15)
4-30-15: 193,346,627 +5,013,755 (4-30-15 10-K iss. 7-14-15)
7-10-15: 199,934,918 +6,588,291 (4-30-15 10-K/cover-pg, iss. 7-14-15)
7-31-15: 200,983,948 +1,049,030 (7-31-15 10Q iss. 9-9-15)
9-4-15: 202,124,031 +1,140,083 (7-31-15 10Q iss. 9-9-15)
10-31-15: 225,824,551 +23,700,520 (10-31-15 10Q iss. 12-10-15)<=Incl. 18.5mm sh. Dart/EastCAP
12-9-15: 229,701,808 +3,877,257 (10-31-15 10Q iss. 12-10-15)
1-31-16: 232,231,242 +2,529,434 (1-31-16 10Q iss. 3-9-16)
3-8-16: 233,738,426 +1,507,184 (1-31-16 10Q iss. 3-9-16)
O/S WARRANTS & STOCK-OPTIONS A/O 1-31-2016 (10-Q pg.15/16):
• WARRANTS: As of 1-31-2016, warrants to purchase 273,280 shares at an exercise price of $2.47 were outstanding and are exercisable through Aug30 2018. These warrants were issued in FY’13 in connection with the Aug.2012 [Oxford] loan agreement, which was paid in full Sept.2012.
• STOCK OPTIONS OUSTANDING A/O 1-31-2016: 23,654,555 shares at a wgt.avg. exercise price of $1.50. (during 9mos. ended 1-31-16, 177,266sh. exercised at avg=.79)
= = = = = = = = = = =PREFERRED STOCK:
...2-5-14: PPHM Announces Public Offering of 10.5% Series E Convertible Preferred Stock http://tinyurl.com/lkxsna6
...2-11-14: PPHM Raises net $16.2mm selling 700k Preferred Shares with 10.5% div. at $25/sh, convertible to common at $3/sh http://tinyurl.com/jwmsnsk (8-K)
...6/14/14-7/14/13: PPHM Raises net $9.5mm selling 400k Preferred Shares with 10.5% div. at $25/sh, convertible to common at $3/sh http://tinyurl.com/mhva3k3 (4-30-14 10-K pg. F-34; $20mm gross remaining)
= = = = = = = = =
CASH a/o 7-31-15: $59.0mm
CASH a/o 10-31-15: $72.0mm
CASH a/o 1-31-16: $67.5mm
OPER.BURN for FY16'Q3 (Nov'15-Jan'16): $15,086,000
Thanks, Chey! The NOBLE "Equity Distribution Agreement" (signed 8-7-15) => 1st used in Q3'FY16 (beg. 11-1-15). I knew there had to be some reason for those addl. ~4mm shares that O/S went up by between 12-10-15 & 3-8-16! I was only looking at the MLV "AUG2015 AMI Agreement". ...Will fix & repost my ATM History post. Thanks again!