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A/o 7-31-17, 4,022,136 stock options o/s at avg=$8.73
Stock Incentive Plans
As of 7-31-17, we had an aggregate of 5,612,106 shares reserved for issuance under our stock incentive plans, of which 4,022,136 were subject to outstanding options and 1,589,970 shares were available for future grants of share-based awards.
...pg.14 10Q, iss. 9-11-17 http://tinyurl.com/ycbzp4zn
A/O 7-31-17:
39,040 warrants o/s with wgt.avg. exercise price of $17.29.
4,022,136 stock options outstanding at a wgt.avg. exercise price of $8.73.
Rob Garnick removed from the MGT-Team webpage.
http://www.peregrineinc.com/about-us/management-team.html
PPHM’s Exosomes Patent App’s (World & U.S.A.)
6-9-16/WORLD-PATENT: Pub# WO/2016/201064, Filed 6-9-16, pub. 12-15-16 (A.Schroit, S.Ward, A.Gazdar)
Title: “Diagnostic Test For Early Stage Cancer”
URL (patentscope.wipo.int): http://tinyurl.com/gqvwkga
The corresponding U.S. PATENT APPLIC: Pub# 20170146542, Filed 6-9-16, pub. 5-25-17 (A.Schroit, S.Ward, A.Gazdar)
USPTO.gov: http://tinyurl.com/y7clom9w “DIAGNOSTIC TEST FOR EARLY STAGE CANCER”
- - - - - - - - - -
NOTE: 2-21-17: Exosomes-RNA.com posts the Exosomes PPHM/Schroit World-Patent App today.
http://www.exosome-rna.com/new-patent-application-published-diagnostic-test-for-early-stage-cancer/
MORE HERE: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=133023785
11-28-17: Profiles of All 7 BOD Members (+Compensation)
Joseph Carleone (Chairman), Richard Hancock, Gregory Sargen, Joel McComb, Roger Lias, Mark Bamforth, Patrick Walsh
COMPENSATION (6 Non-Employee Directors, see: http://tinyurl.com/y7mvg6wt ):
=> SUMMARY: $55000/yr + $15000/committee + $2000/meeting
STOCK:
FORM4 STOCK OPTIONS AWARDED TO ALL 7 BOD’S: ( http://tinyurl.com/6d4jw8 )
Joseph Carleone (Chairman): 75,000 @4.67, vesting monthly over 3yrs beg. 12-27-17
Richard Hancock: 75,000 @4.67 vesting monthly over 3yrs beg. 12-27-17
Gregory Sargen: 75,000 @4.67, vesting monthly over 3yrs beg. 12-27-17
Joel McComb: 75,000 @4.67, vesting monthly over 3yrs beg. 12-27-17
Patrick Walsh: 75,000 @4.08, vesting monthly over 3yrs beg. 11-20-17
Mark Bamforth: 75,000 @3.88, vesting monthly over 3yrs beg. 11-17-17
Roger Lias: 150,000 @3.19, vesting in 4 equal annual installments beg. 9-25-18
OPEN MKT PUR:
...Mark Bamforth Buys 50,000sh. @$4.50 (open mkt) on 10-27-17 http://tinyurl.com/ya7pyyu5
NEW DIRECTORS 11-28-17
Joseph Carleone, PhD (CHAIR, “independent of Ronin/SWIM and new to Peregrine”): Dr. Carleone is Chairman of the Board of AMPAC Fine Chemicals LLC, a leading manufacturer of pharmaceutical active ingredients. Prior to this position, Dr. Carleone was President, CEO and director of American Pacific Corp., a leading custom manufacturer of fine and specialty chemicals and propulsion products. Dr. Carleone has also served or currently serves as an officer and/or a director of several directly or indirectly wholly-owned subsidiaries of American Pacific Corp. Dr. Carleone received his bachelor's degree in Mechanical Eng. from Drexel Univ., Philadelphia, Pennsylvania, in 1968; his master's degree in Applied Mechanics from Drexel University in 1970; and his doctorate degree in Applied Mechanics from Drexel Univ. in 1972.
Richard B. Hancock (Ronin/SWIM appointee): Richard (Rick) B. Hancock has worked in the biologic CDMO industry for over 30 years in various operational and executive roles, serving most recently as President and CEO of Althea Technologies, Inc., a large molecule CDMO producing a wide range of biologics, vaccines and parenteral products. In addition to Althea, Mr. Hancock has held senior management positions at The Immune Response Corporation, and Hybritech Inc. (now part of Eli Lilly & Company), and he is currently the Chairman of the Board and Executive Director of Argonaut Manufacturing Services, Inc., a CDMO focused on the biotechnology and life sciences industries. Mr. Hancock received a BA in Microbiology from Miami University.
Joel McComb (Ronin/SWIM appointee): Joel McComb is the CEO, Chairman and Co-Founder of BioSpyder Technologies, Inc. Prior to BioSpyder, Mr. McComb served as Senior Vice President and General Manager of Illumina, Inc., President of GE Healthcare's Life Sciences and Discovery Systems division, and President of GE Healthcare's Interventional Medicine division. Prior to GE Healthcare, Mr. McComb was the President, CEO and a director of Innovadyne Technologies, Inc., and held various positions at Beckman Coulter, Inc., and Charles River Laboratories (at the time a division of Bausch & Lomb Inc.) where he was a National Business Manager for the company's monoclonal antibody CDMO division. Mr. McComb earned a Bachelor of Science degree in Genetics from the Univ. of California, Davis and an MBA from Golden Gate University.
Gregory P. Sargen (Ronin/SWIM appointee): Gregory P. Sargen currently serves as Executive Vice President - Corporate Development and Strategy of Cambrex Corp. (NYSE:CBM) ("Cambrex"), a global manufacturer and provider of services to life sciences companies. Prior to his current role, Mr. Sargen served as Executive Vice President and CFO of Cambrex. Prior to Cambrex, Mr. Sargen served as VP of Finance - Chemicals Manufacturing Div. of Fisher Scientific International Inc. (n/k/a Thermo Fisher Scientific Inc.) (NYSE:TMO), and held positions with Merck & Co., Inc. (NYSE:MRK), Heat and Control, Inc. and Ernst & Young LLP. Mr. Sargen is a Certified Public Accountant (non-practicing) and holds an MBA in Finance from The Wharton School of the Univ. of Pennsylvania and a B.S. in Accounting from Pennsylvania State University.
EXISTING PPHM DIRECTORS PRIOR TO 11-28-17
Patrick D. Walsh (joined 10-24-17): Mr. Walsh currently serves as CEO of Avista Pharma Solutions [https://www.avistapharma.com ], a high-growth CDMO with over 220,000sf of facility space that provides pharmaceutical clients with a full suite of service offerings including analytical, microbiology, API, formulation, drug substance & drug product mfg. expertise & capabilities. Prior to joining Avista Pharma, he was CEO of AAIPharma Services, a private-equity backed CDMO at which he led a successful growth strategy culminating in the company's sale for more than 4.5 times return on invested capital. Mr. Walsh also held the positions of Pres. & COO of Gensia-Sicor, during which time he led the company's commercial growth strategy, culminating in the eventual sale to Teva for $3.4B. Prior to Gensia, he spent 10yrs in a global pharmaceutical company culminating in leading the U.S. and intl. business of a leading Japanese pharma company. Mr. Walsh has served on pharma boards as chairman, non-executive chairman and company director, as well as an executive advisor to private equity & venture capital firms. He currently serves on the board of Avista Pharma, which is backed by private-equity firm Ampersand Capital Partners.
10-24-17 PR: “Mr. Walsh's record of leading successful, high-growth CDMOs is well-documented in the industry and he has also led complex laboratory and pharmaceutical mfg. operations, including parenteral & active pharmaceutical ingredients (API) on a global scale.”
Mark R. Bamforth (joined 10-19-17): Mark R. Bamforth currently serves as Pres./CEO of Brammer Bio, a cell & gene therapy CDMO he founded in 2015 and merged with Florida Biologix, an established, 10yo CDMO, in 3-2016. In this role, he oversees a team of 300+ emps, providing services ranging from process dev. and early clinical supply services to production of Ph3 supplies & support for licensure of gene therapy products. Previously, he founded Gallus BioPharmaceuticals, a biologics CDMO that experienced rapid growth leading to its acquisition by DPx Holdings B.V., the parent company of Patheon, in 2014 for $257.2M.
Prior to his founding of Brammer Bio & Gallus BioPharmaceuticals, Mr. Bamforth spent 22yrs with Genzyme Corp., rising to the position of SVP/Corp.Oper./Pharmaceuticals. In this role, he oversaw a multi-technology, global operations team comprised of 3,600+ at 13 internal sites & a network of 24 CMO’s. This team was charged with supplying 20+ commercial products and multiple clinical products that spanned biologics, cell therapy, gene therapy, pharmaceuticals and biologic devices. While at Genzyme, Mr. Bamforth served as a member of the CEO's operating committee, helping to guide corporate strategy acquisition, partnering and growth to over $4B in sales.
10-19-17/PR/S.King: "Mark is a great addition to the board of directors as we continue our transition to becoming a dedicated CDMO business. With his extensive experience in the CDMO space, both as an entrepreneur who has founded, grown, acquired and sold a successful CDMO company, as well as his experience as a key executive at Genzyme Corp., he is ideally suited to help oversee the transition of the company into a leading CDMO. Combined with the recent appointment of Dr. Roger Lias as Pres. of Avid and member of Peregrine's BOD, today's appointment further underscores our commitment to reconstitute the BOD with high quality CDMO industry experience.”
Roger J. Lias, PhD (joined 9-11-17): Roger J. Lias has held senior mgt. positions at several leading CDMOs including Cytovance Biologics, KBI BioPharma, Diosynth RTP (formerly Covance Biotechnology Services) and Lonza Biologics. At each of these companies, he was primarily charged with overseeing commercial operations, including growing and diversifying their respective client bases. During this time, Dr. Lias' achievements ranged from building start-up Cytovance's contract process development and biopharmaceutical cGMP production business, to increasing revenues at Diosynth from $16 million to $120 million over a four-year period. Additionally, he has built a reputation as a highly regarded CDMO industry advocate who has contributed to the acceptance and growth of the biologics contract manufacturing market. Dr. Lias earned his Ph.D. from Clare College at the Univ. of Cambridge in the United Kingdom. Dr. Lias most recently served as executive director, head of global biologics business development for Allergan plc., where he was responsible for developing and executing strategies designed to support the company's business development activities related to innovative biologics, biosimilars and complex injectable products. In this role, he was instrumental in identifying, structuring and negotiating a biosimilars co-development collaboration with Amgen for four oncology biosimilar monoclonal antibody products. Prior to Allergan, Dr. Lias was president and group commercial director for Eden Biodesign, an established biopharmaceutical contract manufacturer and consultancy and wholly-owned subsidiary of Eden Biopharma Group. During his time with Eden Biodesign, he successfully transitioned the company's CDMO client base from early-stage biotechnology companies to established biotechnology and multinational pharmaceutical companies, while also playing a key role in the eventual sale of Eden Biopharma Group to Watson Pharmaceuticals (now Allergan).
9-11-17/PR/S.King: “We are very pleased to have the opportunity to bring someone with Roger's impressive track record within the CDMO industry to help guide expansion and growth of the business. Roger has a solid track record of success in driving business expansion, growing revenues and building stockholder value. We are looking forward to seeing the positive impact Roger can have on the Avid business and I look forward to closely working with him to maintain the continuity of the business during the coming transition."
= = = = = = = = = = = = = = = = = = = =
11-28-17: FULL HISTORY of PPHM-Ronin PR’s, Letters, 13-D’s, Form4’s, Proxy’s, etc: https://tinyurl.com/y7g72zh4
KNOWN UPCOMING:
~Dec11: FY'18Q2 (qe 10-31-17) Financials & Conf. Call - http://ir.peregrineinc.com/events.cfm
Dec11-15/Avid Booth #311: KNect365’s Antibody Eng. & Therapeutics Conf., SanDiego https://lifesciences.knect365.com/antibody-engineering-therapeutics
Jan18: Peregrine's 2017 Annual Shareholder’s Meeting – 11-13-17/PR: http://tinyurl.com/y9tdcob5 VotingRecDate: 11-27-17
11-28-17: PPHM+RONIN Settle, 4 New Directors eff. Immediately
NEW BOD(7): Joseph Carleone (Chair), Richard Hancock, Gregory Sargen, Joel McComb, Roger Lias, Mark Bamforth, Patrick Walsh (King, Johnson, Swartz, Pohl resign).
...11-28-17/8-K Header: https://tinyurl.com/y8m35nax
……….8-K/ex10.1 Complete Agreement: https://tinyurl.com/y7b3gkc2
http://www.peregrineinc.com => About => BOD
Chairman is Joseph Carleone (PhD, “Independent of Ronin/SWIM and new to Peregrine”)
Committee makeup specified:
11-28-17: “Peregrine Pharmaceuticals, Ronin Trading & SW Investment Mgt. Announce Settlement Agreement - Peregrine Board Reconstituted with 4 New Independent Directors”
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=1049961
TUSTIN & CHICAGO, Nov. 28, 2017: Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM/PPHMP) and Ronin Trading LLC, and SW Investment Mgt. LLC (together, "Ronin/SWIM"), collectively Peregrine's largest stockholder, today announced that they have entered into a settlement agreement regarding the composition of Peregrine's board of directors and certain matters related to the upcoming 2017 Annual Meeting of Stockholders scheduled for Jan. 18, 2018.
Under the terms of the Agreement, on November 27, 2017, directors Steven W. King, Carlton M. Johnson, Jr., Eric S. Swartz and David H. Pohl each tendered his resignation, effective immediately, from Peregrine's board of directors, and from the board of directors of its wholly-owned subsidiary, Avid Bioservices, Inc. The vacancies created by these resignations were immediately filled by 3 individuals who were nominated by Ronin/SWIM for election at Peregrine's upcoming 2017 Annual Meeting of Stockholders (Richard B. Hancock, Gregory P. Sargen, and Joel McComb), and one director (Joseph Carleone, PhD) who is independent of Ronin/SWIM and new to Peregrine. Roger J. Lias, PhD, Mark R. Bamforth, and Patrick D. Walsh, the remaining members of Peregrine's and Avid's original boards, will continue to serve in their respective roles with the company.
"We are pleased to have reached an agreement with Ronin/SWIM and believe that the addition of Messrs. Carleone, Hancock, McComb, and Sargen, each with significant experience in the biomanufacturing industry, will add great value as we work to establish Avid as a leading contract development and manufacturing organization," stated Roger J. Lias, PhD, President of Avid Bioservices.
Stephen White of Ronin/SWIM said, "We are pleased that we were able to reach a constructive agreement with Peregrine to reconstitute the board with new independent directors. Rick, Greg, Joel, and Joe bring important experience, expertise and perspectives to Peregrine, and we are confident that they, together with Roger, Mark and Pat, will be able to successfully lead the company forward and deliver value for stockholders."
As part of the Agreement, Ronin/SWIM, which collectively beneficially owns 9.6% of Peregrine's outstanding shares of common stock, withdrew its nomination of 6 candidates for election to Peregrine's board of directors at the upcoming 2017 Annual Meeting of Stockholders [1-18-18] and has agreed to certain standstill restrictions until the date that is 30 calendar days after the 2018 Annual Meeting of Stockholders [~Oct/Nov2018]. Peregrine has also agreed to re-nominate a number of Ronin/SWIM's appointees at the 2018 Annual Meeting of Stockholders.
The complete Agreement will be included as an exhibit to the company's current report on Form 8-K, which will be filed with the SEC.
...11-28-17/8-K Header: https://tinyurl.com/y8m35nax
……….8-K/ex10.1 Complete Agreement: https://tinyurl.com/y7b3gkc2
NEW DIRECTORS
Joseph Carleone, PhD (independent appointee): Dr. Carleone is Chairman of the Board of AMPAC Fine Chemicals LLC, a leading manufacturer of pharmaceutical active ingredients. Prior to this position, Dr. Carleone was President, CEO and director of American Pacific Corporation, a leading custom manufacturer of fine and specialty chemicals and propulsion products. Dr. Carleone has also served or currently serves as an officer and/or a director of several directly or indirectly wholly-owned subsidiaries of American Pacific Corporation. Dr. Carleone received his bachelor's degree in Mechanical Eng. from Drexel University, Philadelphia, Pennsylvania, in 1968; his master's degree in Applied Mechanics from Drexel University in 1970; and his doctorate degree in Applied Mechanics from Drexel Univ. in 1972.
Richard B. Hancock (Ronin/SWIM appointee): Richard (Rick) B. Hancock has worked in the biologic CDMO industry for over 30 years in various operational and executive roles, serving most recently as President and CEO of Althea Technologies, Inc., a large molecule CDMO producing a wide range of biologics, vaccines and parenteral products. In addition to Althea, Mr. Hancock has held senior management positions at The Immune Response Corporation, and Hybritech Inc. (now part of Eli Lilly & Company), and he is currently the Chairman of the Board and Executive Director of Argonaut Manufacturing Services, Inc., a CDMO focused on the biotechnology and life sciences industries. Mr. Hancock received a BA in Microbiology from Miami University.
Joel McComb (Ronin/SWIM appointee): Joel McComb is the CEO, Chairman and Co-Founder of BioSpyder Technologies, Inc. Prior to BioSpyder, Mr. McComb served as Senior Vice President and General Manager of Illumina, Inc., President of GE Healthcare's Life Sciences and Discovery Systems division, and President of GE Healthcare's Interventional Medicine division. Prior to GE Healthcare, Mr. McComb was the President, CEO and a director of Innovadyne Technologies, Inc., and held various positions at Beckman Coulter, Inc., and Charles River Laboratories (at the time a division of Bausch & Lomb Inc.) where he was a National Business Manager for the company's monoclonal antibody CDMO division. Mr. McComb earned a Bachelor of Science degree in Genetics from the Univ. of California, Davis and an MBA from Golden Gate University.
Gregory P. Sargen (Ronin/SWIM appointee): Gregory P. Sargen currently serves as Executive Vice President - Corporate Development and Strategy of Cambrex Corp. (NYSE:CBM) ("Cambrex"), a global manufacturer and provider of services to life sciences companies. Prior to his current role, Mr. Sargen served as Executive Vice President and CFO of Cambrex. Prior to Cambrex, Mr. Sargen served as VP of Finance - Chemicals Manufacturing Div. of Fisher Scientific International Inc. (n/k/a Thermo Fisher Scientific Inc.) (NYSE:TMO), and held positions with Merck & Co., Inc. (NYSE:MRK), Heat and Control, Inc. and Ernst & Young LLP. Mr. Sargen is a Certified Public Accountant (non-practicing) and holds an MBA in Finance from The Wharton School of the Univ. of Pennsylvania and a B.S. in Accounting from Pennsylvania State University.
ABOUT PEREGRINE PHARMACEUTICALS, INC.
Peregrine Pharmaceuticals, Inc. is a company transitioning from an R&D focused business to a pure play contract development and manufacturing organization (CDMO). 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 ). Peregrine is pursuing licensing or selling its proprietary R&D assets, including its lead immunotherapy candidate, bavituximab, which is currently being evaluated in clinical trials in combination with immune stimulating therapies for the treatment of various cancers. For more information, please visit http://www.peregrineinc.com .
ABOUT AVID BIOSERVICES, INC.
Avid Bioservices, a wholly owned subsidiary of Peregrine Pharmaceuticals, provides a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With over 20 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 .
ABOUT RONIN TRADING, LLC
Ronin Trading, LLC and its affiliate Ronin Capital, LLC are global, multi-strategy proprietary trading firms.
ABOUT SW INVESTMENT MANAGEMENT LLC
SW Investment Management LLC is an investment adviser based in Chicago.
Contacts:
Stephanie Diaz (Investors) Vida Strategic Partners 415-675-7401 sdiaz@vidasp.com
Tim Brons (Media) Vida Strategic Partners 415-675-7402 tbrons@vidasp.com
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See below for full PPHM-RONIN History of PR’s, Letters, 13-D’s, Form4’s, and Proxy’s (sorted: newest=>oldest).
KNOWN UPCOMING:
~Dec11: FY'18Q2 (qe 10-31-17) Financials & Conf. Call - http://ir.peregrineinc.com/events.cfm
Dec11-15/Avid Booth #311: KNect365’s Antibody Eng. & Therapeutics Conf., SanDiego https://lifesciences.knect365.com/antibody-engineering-therapeutics
Jan18: Peregrine's Annual Shareholder’s Meeting – 11-13-17/PR: http://tinyurl.com/y9tdcob5
= = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
11-13-17: Large Ownership Summary(40.3%) - now 18,163,171shs., 40.3% of 45,096,081 O/S at 9-6-17.
(Ronin+SW/Stafford+Farley+White, Eastern Cap./K.Dart, Institutions incl. Tappan’s 11-13-17/13G)
#1: 10-27-17/PR: Group Ronin Trading/SWInvest (John Stafford III+R.Farley+Stephen White) now has 9.6% stake (4,325,889sh.) in PPHM
...4,173,391 COMMON – 9.3% of 45,096,081 common O/S at 9-6-17 (total beneficial=4,325,889 if Pref. conv. x1.1905 to Common)
...128,099 PREFERRED – 7.8% of 1,647,760 preferred O/S at 7-31-17
NOTE: ALL historical common #’s adjusted for the 1:7 R/S eff. 7-10-17.
#2: 10-30-15: Kenneth Dart (Eastern Capital) acquires 9.5% stake (4,300,992sh.) in PPHM http://tinyurl.com/y95yskck
...3,777,183 COMMON – 8.4% of 45,096,081 common O/S at 9-6-17 (total beneficial=4,300,992 if Pref. conv. x1.1905 to Common, 9.5%)
...440,000 PREFERRED – 26.7% of 1,647,760 preferred O/S at 7-31-17
…...9-29-17/Form4: http://tinyurl.com/y9oadloa <=No chg. In Ownership; status update?
RONIN/SW 13D SUMMARY:
13D TransDates COMMON-CHG PREF-CHG ENDING-COMMON ENDING-PREF.
3-2-17 1/20/17-3/1/17 +2,947,425 +51,364 2,947,425 51,364 http://tinyurl.com/jr42u23
3-10-17 3/2/17-3/9/17 +433,509 +25,661 3,380,934 77,025 http://tinyurl.com/ydxra96u
4-17-17 3/28/17-4/10/17 0 +23,334 3,380,934 100,359 http://tinyurl.com/lanjddc
5-19-17 5/1/17-5/17/17 0 +23,140 3,380,934 123,499 http://tinyurl.com/mgnn92x
6-20-17 3/10/17-6/16/17 +378,170 0 3,759,105 123,499 http://tinyurl.com/y76q5rqu
6-29-17 6/21/17 +7,143 0 3,766,248 123,499 http://tinyurl.com/y9sp8bfv
7-14-17 6/29/17-7/7/17 +34,891 +3,600 3,801,139 127,099 http://tinyurl.com/ybra4s69
8-29-17 8/4/17-8/15/17 +27,252 0 3,828,391 127,099 http://tinyurl.com/yay55u3p (14A)
10-10-17 8/16/17-10/10/17 +45,000 0 3,873,391 127,099 http://tinyurl.com/ybvkjd3e (14A)
10-17-17 10/13/17-10/16/17 +109,573 +1,000 3,982,964 128,099 http://tinyurl.com/y983myco
10-27-17 10/17/17-10/27/17 +190,427 0 4,173,391 128,099 http://tinyurl.com/y7hslequ (14A)
SPLITOUT 13D GROUP into Ronin(John Stafford III, R.Farley) & SW-Partners(Stephen White):
Ronin Trading (Stafford) 3,173,391 115,299 (beneficial=3,310,652)
Ronin’s Roger Farley 300,000 1,000 (beneficial=301,190)
SW-Partners (White) 700,000 11,800 (beneficial=714,047)
- - - - - - - - - - - - - - -
Plus, INSTITUTIONS a/o *9-30-17: 9,536,290sh. = 21.1% <=*incl. Tappan’s 11-13-17/13G
...8,491,679 + 1,044,611(Tappan adds after 9-30-17) = 9,536,290
http://www.nasdaq.com/symbol/pphm/institutional-holdings
TOP13:
Tappan St. Partners 3,915,611 +2,259,359 <=per 11-13-17/13G(see below**)
Vanguard Group 1,518,110 +488,355
Blackrock (Larry Fink) 761,302 -44,720
Bandera Partners 555,000 +351,996
Renaissance Technologies 547,190 +66,030
Geode Capital Mgt. 225,676 -3
Fondren Mgt. 205,000 NEW
Stifel Financial 204,305 +200,762
Eqis Capital Mgt. 143,595 -6,804
Wells Fargo & Co. 117,829 +69,488
Connor Clark & Lunn 98,772 NEW
Brown Advisory Sec. 82,858 -1
Pdt Partners 82,800 NEW
And this big Q3 drop:
#18 Kennedy Capital Mgt. 69,820 -1,324,246
**11-13-17/13G: Tappan Street (Prasad Phatak) http://tinyurl.com/y85pz4fs
2 Funds + P.Phatak’s personal shares:
...Partners LLC, Tappan St. Fund L.P. 1,540,000 0
...Tappan St. Partners Ideas Fund L.P. 2,289,504 +1,597,927 since 8-14-17
...Prasad Phatak (Principle Owner) 86,107 +19,000 since 8-14-17
Total TAPPAN: 3,915,611 (8.5%)
Note: Tappan Street (total) Holdings history:
a/o 3-31-17: 914,304
a/o 6-30-17: 1,656,252
a/o 8-14-17: 2,298,684 5.1% (of 45,069,188 O/S as of 7-11-17)
a/o 9-30-17: 2,871,000 6.4% (of 45,096,081 O/S as of 9-11-17)
a/o 11-6-17: 3,915,611 8.5% (of 45,096,081 O/S as of 9-11-17)
Final Qtly Inst. Holdings from Nasdaq:
3-31-17: 5,690,888
6-30-17: 6,834,425
9-30-17: 8,491,679
New BOD(7) Added to Website (Chairman=Joseph Carleone)
http://www.peregrineinc.com => About => BOD
Chairman is Joseph Carleone (PhD, “Independent of Ronin/SWIM and new to Peregrine”)
Committee makeup specified:
= = = = = = = = = = =
11-28-17: PPHM+RONIN Settle, 4 New Directors eff. Immediately
NEW BOD(7): Richard Hancock, Gregory Sargen, Joel McComb, Joseph Carleone, Roger Lias, Mark Bamforth, Patrick Walsh (King, Johnson, Swartz, Pohl resign).
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=136494706
...11-28-17/13D-Ex.A Complete Agreement: https://tinyurl.com/y89x92lm
Several months back I archived all the TNT/Cotara iBox entries (and several other inactive sections of iBox) to a separate archive post, easily linked to and assessable to via a clickable URL in iBox.
...If you look down in iBox you will see the link to that archival.
I’m away right now with only my iPhone, so I can’t copy/paste the link to the TNT/Cotara link in iBox, but if you look in there, it’s easily seen and it is easy to click to it and bring up the full original history.
Avid Event 12-7-17: So.Calif. Biomedical Council “Lunch+Learn”
Dec7 2017: “SoCalBio Lunch & Learn: Accelerating Your Drug R&D Processes & Time to Market”, Tustin
Southern California Biomedical Council http://socalbio.org
https://www.eventbrite.com/e/socalbio-lunch-learn-accelerating-your-drug-rd-processes-and-time-to-market-tickets-39058674547
12-7-17 11am-2pm:
TOUR OF AVID, PRESENTATION, NETWORKING
...Avid's services include cGMP clinical and commercial biologics manufacturing, purification, bulk packaging, lot release and stability testing, regulatory strategy, submission, and support. The company also provides a variety of process dev. activities, including cell line dev. & optimization, cell culture & feed optimization, analytical methods dev., qualification/validation, process & product characterization.
Why do you take Ronin's candidate JamesJ.Egan and start talking about "Mark Egan"? Aren't they different and unrelated people?
No idea, Huts. Maybe all the way back to 2010??
This Thomas/PT(?) article is all about AntiPS v. Viral Hemorrhagic Fevers (VHF). I’m think maybe something he assisted Dr. Thorpe on many years ago. The whole thing is wacky since the article lists “Philip E. Thorpe” as being at: Univ. of Texas @Rio Grande Valley, Dept. of Biology, Edinburg, TX
PR 11-17-2010: BAVI+FHBAVI VS. VHF PRESENTED AT CBDS&T BIODEF. CONF./ORLANDO
Peregrine's Bavituximab Demonstrates Broad Potential in Viral Hemorrhagic Fever Infection Models
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=56938322
The Open Microbiology Journal (ISSN: 1874-2858 ? Vol.11, 2017)
“Protective Effect of Anti-Phosphatidylserine Antibody in a Guinea Pig Model of Advanced Hemorrhagic Arenavirus Infection”
John M. Thomas** 1, Philip E. Thorpe 2
1 Univ. of Texas SW Medical Center, Dept. of Pharmacology, Dallas
. . .Currently **Univ.TX/Rio Grande Valley, Assistant Professor
. . . . https://webapps.utrgv.edu/aa/dm/index.cfm?action=vitae&user=john.thomas
2 Univ of Texas, Dept. of Biology; Edinburg TX
OBJECTIVE:
Host derived markers on virally infected cells or virions may provide targets for the generation of antiviral agents. Recently, we identified phosphatidylserine (PS) as a host marker of virions and virally-infected cells.
METHODS AND MATERIALS:
Under normal physiological conditions, PS is maintained on the inner leaflet of the plasma membrane facing the cytosol. Following viral infection, activation or pre-apoptotic changes cause PS to become externalized. We have previously shown that bavituximab, a chimeric human-mouse antibody that binds PS complexed with B2-glycoprotein I (B2GP1), protected rodents against lethal Pichinde virus and cytomegalovirus infections.
RESULTS:
Here, we determined the antiviral activity of a fully human monoclonal antibody, PGN632, that directly binds to PS. Treatment with PGN632 protected 20% of guinea pigs with advanced infections of the hemorrhagic arenavirus, Pichinde, from death. Combining PGN632 with ribavirin improved the antiviral activity of both agents, such that the combination rescued 50% of animals from death.
CONCLUSION:
The major mechanisms of action of PGN632 appear to be opsonization of virus and antibody-dependent cellular cytotoxicity of virally-infected cells. PS-targeting agents may have utility in the treatment of viral diseases.
https://benthamopen.com/EPUB/BSP-TOMICROJ-2017-76
2010-2014 ARCHIVE OF ANTI-PS/BAVITUXIMAB MOA ARTICLES/PRESENTATIONS
Removed from iBox 11-18-17, and linked and easily clickable to from within iBox...
BAVI MOA 12-12-14 San Antomio Breast Cancer Symposium, Dr. Bruce Freimark, Bavi+anti-PD-1 vs. Breast Cancer http://tinyurl.com/p5ng6vs
BAVI MOA 11-2014 SITC’14: 3 posters on preclin. Bavi+aCTLA4/aPD1 combo data (Hutchins Freimark Brekken Huang etal) http://tinyurl.com/pchzr6h
BAVI MOA 8-28-14: Italy’s Dr. Federico Cappuzzo, Bavi/NSCLC profile article (DovePress OpenAccess, 7pgs) - http://tinyurl.com/n3oa7bc
BAVI MOA 8-11-14: PPHM/VP Dr. Jeff Hutchins’ presentation at ImVacS "Immunotherapies & Vaccine Summit", Boston - PR: http://tinyurl.com/lpjy3u7 ; PDF(31 Slides): http://tinyurl.com/oueldme
...MLV’s Dr. George Zavoico’s 8-27-14 report on Dr. Jeff Hutchins’ 8-11-14 ImVacS/Boston Bavi MOA presentation: http://tinyurl.com/l3tw63c
BAVI MOA 5-28-14: Dr. Rolf Brekken’s 47min CRI “Cancer Immunotherapy” webinar about Bavituximab as an Upstream/Global Immune Checkpoint Inhibitor – REPLAY: http://tinyurl.com/lxgftyx
. . .CRI=Cancer Research Institute (NYC – Supported by BMS): http://www.cancerresearch.org - Facebook: http://tinyurl.com/pbmhb2z , https://twitter.com/CancerResearch
. . .CRI launches “Answer to Cancer” (cancer immunotherapy) website http://www.theanswertocancer.org
. . .8-12-14: CRI adds Youtube links to the 5-28-14 CRI Immunotherapy webinar, incl. Dr. Brekken's talk ”about Bavi and how it works against lung, liver, and other kinds of cancers" http://tinyurl.com/ps5h6h8
BAVI MOA 3-25-14: Dr. Rolf Brekken’s 40min talk at NYAS Lung Cancer Symposium http://tinyurl.com/lq9stnk (45 Slides)
. . .Dr.Brekken’s talk: “Antibody-mediated Inhibition of PS - A Novel Strategy for Immune Checkpoint Blockade” (the 5 speakers: Jessica Donington, Roy Herbst, Balazs Halmos, Suresh Ramalingam, Rolf Brekken)
12-10-13: With recent scientific insights highlighting bavi’s immunostimulatory moa, these additions to PPHM’s SAB: Dimitry Gabrilovich, Scott Antonia, David Carbone**, Hakan Mellstedt http://tinyurl.com/mw776mk
......**A/o 9-2015, Dr. David Carbone (PPHM SAB/KOL) is President of IASLC https://www.iaslc.org/about-us/board
BAVI MOA: 12-2013 Bavi’s Immunotherapeutic MOA overviewed by UTSW’s Brekken/Huang in Pan European Networks Jrnl. http://tinyurl.com/lnb46pq
BAVI MOA 11-9-13: Annual SITC (WashDC) – 2 posters about Bavi’s Immunostimulatory MOA http://tinyurl.com/mjaweu5
...“We are actively working towards initiating a clinical trial in the coming months to further investigate the potential synergistic effects of bavituximab and an approved [anti-CTLA-4] immunotherapy in patients with Melanoma."
10-28-13 IASLC/Sydney: “Immune Checkpoints in the Tumor Environment: Novel Targets & the Clinical Promise of Combined Immunotherapies” http://tinyurl.com/mjaweu5
…Symposium speakers: Scott J. Antonia/MD-PhD(H.Lee Moffitt CC), Dmitry I. Gabrilovich/MD-PhD(Wistar Inst), Rolf A. Brekken/PhD(UTSW), David E. Gerber/MD(UTSW)
BAVI MOA: 8-19-13 Data Supporting Bavituximab’s Immunotherapy MOA Published in “Cancer Immunology Research” (AACR) - http://tinyurl.com/mhjftka (PDF)
…“PS-Targeting Antibody Induces M1 Macrophage Polarization & Promotes Myeloid-Derived Suppressor Cell Differentiation” (Thorpe etal)
BAVI MOA: 8-13-13 PPHM/VP Dr. Jeff Hutchins’ Presentation on the Downstream Immunostimulatory Effects/Moa of PS-targeting antibodies (like Bavi) at CHI’s “Immunotherapies Congress”/Boston http://tinyurl.com/m6h2tvt
BAVI MOA: 10-12-12 NMB article on how Bavi "Induces Innate & Specific Anti-tumor Responses" http://tinyurl.com/cw9odb8
BAVI MOA: 5-1-12 Dr. Phil Thorpe's 46min talk at NYAS PS-Targeting Symposium http://tinyurl.com/9792gl5
. . .Symposium title: ”Phosphatidylserine (PS) Asymmetry - Therapeutic Apps. in Cancer & Infectious Disease Symposium"
. . .Replays of 5 speakers: Alan Schroit, Chris Reutlingsperger, David Ucker, Ari Helenius, Philip Thorpe
BAVI MOA: 5-26-11 Dr.Thorpe's keynoter at Recombinant-Mabs/Barcelona http://tinyurl.com/3klpodc & http://tinyurl.com/3m33h33
BAVI MOA: 4-2010 Thrombosis Research article (Dr.Thorpe) http://tinyurl.com/9reso7s
2006-2012 PS-IMAGING Articles/Presentations ARCHIVED here. Removed from iBox 11-18-17, and linked and easily clickable to from within iBox...
IMAGING APPLICATIONS Of PS-TARGETING MABS:
ARCHIVAL 2006-2012:
10-31-12, New PS-Targeting Preclin. Data - Mabs Stimulate Cancer-Fighting Immune Responses & Specifically Target Tumors http://tinyurl.com/cw9odb8
…10-25-12 SITC Poster on Bavi's MOA, and 10-10-12 NMBA article on "ImmunoPET Imaging of PS" using 89Zr-PGN635 (see Genentech below)
10-12-12: Genentech studying Imaging using PGN635(Fhu-Bavi) for the potential "detection of tumor response to therapy". http://tinyurl.com/8wvem9y
…Nuclear Medicine & Biology, Genentech's Jan Marik, "ImmunoPET Imaging of PS in Pro-Apoptotic Therapy Treated Tumor Models"
4-3-12: Peregrine Launches PS-Targeting Clinical Imaging Program (AACR'12 #2452) http://tinyurl.com/7p7jovt & http://tinyurl.com/7yrwqm7
…PPHM "recently filed an IND" with FDA for an Imaging trial using 124I-PGN650, ~12pts.
...6-28-12: Trial added to trials.gov: http://clinicaltrials.gov/ct2/show/NCT01632696 - see CANCER TRIALS ABOVE for more details.
12-2011: Thorpe Article on FH-Bavi/Optical-Imaging in Translational Oncology http://tinyurl.com/7vcnbz2
11-14-11: Dr. Bruce Freimark presents PS IMAGING poster at AACR-NCI-EORTC Conf./SanFran http://tinyurl.com/89hpydn
9-12-11: Drs. Thorpe & Freimark present PS IMAGING posters at World Imaging Congress/S.Diego http://tinyurl.com/3uv5rgr
9-9-11: PS IMAGING potential discussed in Qtly. Conf. Call: http://tinyurl.com/3q7hzjh
4-2011/Neoplasia: Dr. Thorpe 9-pg. article on Exposed-PE/Imaging http://tinyurl.com/5uoy6fh
…Dr. Thorpe: "PE also has potential as a marker for Imaging human malignancies."
4-6-11/AACR'11: Tumor Imaging Applications of PS-Targeting Antibodies http://tinyurl.com/68p9zs4
…Steve King: "Molecular imaging is a growing field and represents an entirely new development opportunity for our first-in-class PS-targeting antibody platform… our antibodies labeled with imaging tracers hold potential for illustrating exposed PS in a clinical oncology setting, imaging PS as a companion diagnostic with bavituximab therapy, as well as ultimately assessing patient response to a range of cancer therapies."
3-14-11: Dr. Thorpe discusses PS IMAGING in Conf. Call: http://tinyurl.com/4p4hqr5
…Dr. Thorpe: "The quality of the images is quite extraordinary. The antibody homes to tumor blood vessels beautifully in all tumors that we've seen with really very, very little of a staining seen in other tissues, and that's just what you'd like to see in a diagnostic - we are looking at that very seriously. And also, that binding is correlated to response, both with radiotherapy & chemotherapy. So again, we have the possibility of making a diagnostic that would be predictive of response. We are evaluating that possibility at this time... Duramycin binds PE; binding PE expands our coverage of our broad aminophospholipid-targeting platform, so it really dovetails very beautifully with the existing antibody portfolios. It's expanding our desire to explore different phospholipids as potential targets for therapy & diagnosis… PE is phosphatidylethanolamine and it is the brother of PS. So where PE goes, so does PS and vice versa. So the 2 lipids co-segregate normally on the inside surface of the plasma membrane, but in activated cells or apoptotic cells or stress cells, both lipids flip, and both are potential targets for therapeutics or diagnostics… Duramycin is a little peptide, that's a small molecule and has quite different qualities from an antibody in terms of penetrants. So we're intrigued to see how it plays out, too."
6-24-09 U.S. Patent #7,550,141 granted: Anti-PS for Tumor Imaging: http://tinyurl.com/ln9ub8
3-3-08: Thorpe/Mason C.C.R. (AACR) article on Arsenic-labeled Bavi for Imaging Tumors: http://tinyurl.com/32jbfl
…3-5-08 Chemistry World followup article on CCR Bavi+Arsenic/IMAGING: http://tinyurl.com/4m4lbse
2006/SMI: Thorpe/Mason, "Optical Imaging of Exposed PS in Tumors" http://tinyurl.com/42nh7d9
…"We believe optical imaging with Bavituximab holds great promise for assessing PS expression, and therapeutic activity in vivo and optimizing treatment protocols."
My guess is the 8-2017 “EnAbl” trademark has to do with the new Avid “Antibody Discovery Platform” SK talked about in the 7-14-17 CC, and was added to the 4-30-17 10-K iss. 7-14-17...
S.King 7-14-17: “Another part of our effort to attract new customers is to expand our service offerings. Our scientists have developed a state-of-the-art Antibody Discovery & Characterization Platform through which we can generate antibodies against virtually any target. These capabilities are meant to allow rapid screening for high affinity antibodies that are developable. These capabilities are a natural extension of the services we already offer through Avid and it represents an attractive way to bringing customers at a much earlier stage of development with the potential to move them quickly into process developments and cGMP manufacturing. . .
The Antibody Discovery Platform discussed earlier [Avid] could also be instrumental on the R&D side of the business, allowing us to rapidly identify antibodies against already validated targets, as well as the potential to identify novel targets. As we think about diversifying our development pipeline to include lower risk, already validated targets, this new capability could help us to identify developable antibodies that could have short-term value, as the need for such antibodies is on the rise. And this approach fits very well into our core capabilities and experience in the development of monoclonal antibodies. You can expect to hear more about this new capability over the coming months on both sides of our business.” http://tinyurl.com/yb4wulvu
= = = = = = = = =
ENABL - Trademark Details – filed 8-1-17
Party Name: Peregrine Pharmaceuticals, Inc.
https://trademarks.justia.com/875/51/enabl-87551219.html
Goods/Svcs: “R&D services performed for others in the fields of pharmaceutical, medicinal and drug products; namely, R&D services performed for others and research under contract in the fields of antibody libraries, phages, phage display, identifying candidate therapeutic antibodies and manufacture of therapeutic antibodies.”
= = = = = = = = = = = = = = = = = = = = = =
PPHM’s 4-30-17 10-K pub. 7-14-17 pg.5:
Antibody Discovery Technology
“Recently, our scientists have developed an antibody discovery and characterization platform through which we can generate antibodies against virtually any target. These capabilities are state-of-the-art and meant for rapid screening for high affinity antibodies as drug candidates. These capabilities are a natural extension of the services we already offer through Avid and it may represent a way to bring in customers at a much earlier stage of development with the potential to move them quickly into process development and cGMP manufacturing. Continuing to diversify our customer base is one of our key initiatives at Avid and we believe the antibody discovery capabilities will help attract new customers. The antibody discovery capabilities can also be used in our R&D business to rapidly identify antibodies against known targets as well as to identify novel targets. The antibody discovery platform is now fully functional and we are in the process of evaluating the technology through identifying several known targets and thus far, the results have looked promising. Once this process is completed, the technology platform will be marketed to potential customers as part of our CDMO service offerings.” http://tinyurl.com/ycxu4l5n
Here’s the 10-21-17 post detailing WCLC’17/Japan (Sunrise subset)
Oct15-18 2017: “WCLC’17 - IASLC’s 18th World Conf. on Lung Cancer”, Yokohama, Japan
Track: Immunology & Immunotherapy, Presentation: Mini-Oral #MA 10
10-17-17 11:30-11:35pm #MA 10.05 (Mini-Oral):
“Improved Outcome for Immune Checkpoint Inhibitors (ICI) in Patients Previously Treated with Bavituximab in the SUNRISE Trial”
FULL info here: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=135586168
= = = = =And then SITC’17 (Sunrise #P87):
Nov8-12 2017: “(SITC) Society for Immunotherapy of Cancer 32nd Annual Meeting”, Natl-Harbor MD
#P87: “Results of Epigenetic-Based Quantitative PCR Assisted Immune Cell Counting Analysis in Bavituximab SUNRISE Trial Subgroup”
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=136007486
Nice Find, Huts: 11-15-17/Outsourcing-Pharma article (re: SK/RL Interviews)
“How This R&D Company (Peregrine) is Transitioning to a Pure-Play CDMO: ‘Opportunities Are Almost Endless’" - Melissa Fassbender
Recap of interviews with Steve King & Avid Pres. Roger Lias http://tinyurl.com/y7dv9faz
...Excerpt: THE FUTURE AS A CDMO: Lias' 1st objective as the new Pres. of Avid will be to ramp up visibility & bus. dev., he told us. Short term, the strategy is to fully consolidate as a multi-product CDMO. As part of this, the company is currently looking to license or sell its proprietary R&D assets, including Bavituximab. “One of the first things we’ll do is bolster our capabilities for our early phase work,” said Lias. “We need more,” he added. Beyond that, Lias said the next steps will be aligning the organization to be able to better serve multiple clients. The company will grow organically and M&A is, “of course,” a potential, he explained. The company will also look diversify its service offerings and may deploy new “copycat” facilities, though no locations have been chosen at this time. “The opportunities are almost endless out there at the moment,” concluded Lias.
https://muckrack.com/melissa-fassbender
Prev. post updated with final 9-30-17 Nasdaq INST-Holdings
11-15-17: Updated Nasdaq INST.HOLDINGS: 8,375,487 at 9-30-17, up from 6,834,425 at 6-30-17. Add in Tappan’s 11-13-17 13G(trans. 11-6-17) +1,044,611 adds after 9-30-17, and total INST. now 9,420,098 (20.5%).
= = = = = = = = =
11-13-17: Large Ownership Summary(40.0%) - now 18,046,979shs., 40.0% of 45,096,081 O/S at 9-6-17.
(Ronin+SW/Stafford+Farley+White, Eastern Cap./K.Dart, Institutions incl. Tappan’s 11-13-17/13G)
#1: 10-27-17/PR: Group Ronin Trading/SWInvest (John Stafford III+R.Farley+Stephen White) now has 9.6% stake (4,325,889sh.) in PPHM
...4,173,391 COMMON – 9.3% of 45,096,081 common O/S at 9-6-17 (total beneficial=4,325,889 if Pref. conv. x1.1905 to Common)
...128,099 PREFERRED – 7.8% of 1,647,760 preferred O/S at 7-31-17
NOTE: ALL historical common #’s adjusted for the 1:7 R/S eff. 7-10-17.
#2: 10-30-15: Kenneth Dart (Eastern Capital) acquires 9.5% stake (4,300,992sh.) in PPHM http://tinyurl.com/y95yskck
...3,777,183 COMMON – 8.4% of 45,096,081 common O/S at 9-6-17 (total beneficial=4,300,992 if Pref. conv. x1.1905 to Common, 9.5%)
...440,000 PREFERRED – 26.7% of 1,647,760 preferred O/S at 7-31-17
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=136214554
Large/Sh.Holders(40%) & RONIN-PPHM HISTORY, upd/11-15-17: ASM=>1/18/18
1. 1-13-17: PPHM announces ASM date of 1-18-18, to be held at Avid’s Myford Facility, Tustin. Holders of the company's common stock on Nov. 27, 2017, the record date, will be entitled to receive notice of and vote their shares at the 2017 ASM Meeting. http://tinyurl.com/y9tdcob5
2. 11-13-17: New 11-13-17 13G http://tinyurl.com/y85pz4fs shows Tappan St. Partners added 1,616,927sh since 8-14-17, now at 3,915,611 (8.5% of 45,096,081). Tappan becomes the 3rd largest, behind Ronin & E.Capital(K.Dart). Since 6-30-17, Tappen has added +2,259,359. (see below)
3. 11-15-17: Updated Nasdaq INST.HOLDINGS: 8,375,487 at 9-30-17, up from 6,834,425 at 6-30-17. Add in Tappan’s 11-13-17 13G(trans. 11-6-17) +1,044,611 adds after 9-30-17, and total INST. now 9,420,098 (20.5%). - see below.
NOTE:
See below for full PPHM-RONIN History of PR’s, Letters, 13-D’s, Form4’s, and Proxy’s (sorted: newest=>oldest).
KNOWN UPCOMING:
~Dec11: FY'18Q2 (qe 10-31-17) Financials & Conf. Call - http://ir.peregrineinc.com/events.cfm
Dec11-15/Avid Booth #311: KNect365’s Antibody Eng. & Therapeutics Conf., SanDiego https://lifesciences.knect365.com/antibody-engineering-therapeutics
Jan18: Peregrine's Annual Shareholder’s Meeting – 11-13-17/PR: http://tinyurl.com/y9tdcob5
= = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
11-13-17: Large Ownership Summary(40.0%) - now 18,046,979shs., 40.0% of 45,096,081 O/S at 9-6-17.
(Ronin+SW/Stafford+Farley+White, Eastern Cap./K.Dart, Institutions incl. Tappan’s 11-13-17/13G)
#1: 10-27-17/PR: Group Ronin Trading/SWInvest (John Stafford III+R.Farley+Stephen White) now has 9.6% stake (4,325,889sh.) in PPHM
...4,173,391 COMMON – 9.3% of 45,096,081 common O/S at 9-6-17 (total beneficial=4,325,889 if Pref. conv. x1.1905 to Common)
...128,099 PREFERRED – 7.8% of 1,647,760 preferred O/S at 7-31-17
NOTE: ALL historical common #’s adjusted for the 1:7 R/S eff. 7-10-17.
#2: 10-30-15: Kenneth Dart (Eastern Capital) acquires 9.5% stake (4,300,992sh.) in PPHM http://tinyurl.com/y95yskck
...3,777,183 COMMON – 8.4% of 45,096,081 common O/S at 9-6-17 (total beneficial=4,300,992 if Pref. conv. x1.1905 to Common, 9.5%)
...440,000 PREFERRED – 26.7% of 1,647,760 preferred O/S at 7-31-17
…...9-29-17/Form4: http://tinyurl.com/y9oadloa <=No chg. In Ownership; status update?
RONIN/SW 13D SUMMARY:
13D TransDates COMMON-CHG PREF-CHG ENDING-COMMON ENDING-PREF.
3-2-17 1/20/17-3/1/17 +2,947,425 +51,364 2,947,425 51,364 http://tinyurl.com/jr42u23
3-10-17 3/2/17-3/9/17 +433,509 +25,661 3,380,934 77,025 http://tinyurl.com/ydxra96u
4-17-17 3/28/17-4/10/17 0 +23,334 3,380,934 100,359 http://tinyurl.com/lanjddc
5-19-17 5/1/17-5/17/17 0 +23,140 3,380,934 123,499 http://tinyurl.com/mgnn92x
6-20-17 3/10/17-6/16/17 +378,170 0 3,759,105 123,499 http://tinyurl.com/y76q5rqu
6-29-17 6/21/17 +7,143 0 3,766,248 123,499 http://tinyurl.com/y9sp8bfv
7-14-17 6/29/17-7/7/17 +34,891 +3,600 3,801,139 127,099 http://tinyurl.com/ybra4s69
8-29-17 8/4/17-8/15/17 +27,252 0 3,828,391 127,099 http://tinyurl.com/yay55u3p (14A)
10-10-17 8/16/17-10/10/17 +45,000 0 3,873,391 127,099 http://tinyurl.com/ybvkjd3e (14A)
10-17-17 10/13/17-10/16/17 +109,573 +1,000 3,982,964 128,099 http://tinyurl.com/y983myco
10-27-17 10/17/17-10/27/17 +190,427 0 4,173,391 128,099 http://tinyurl.com/y7hslequ (14A)
SPLITOUT 13D GROUP into Ronin(John Stafford III, R.Farley) & SW-Partners(Stephen White):
Ronin Trading (Stafford) 3,173,391 115,299 (beneficial=3,310,652)
Ronin’s Roger Farley 300,000 1,000 (beneficial=301,190)
SW-Partners (White) 700,000 11,800 (beneficial=714,047)
- - - - - - - - - - - - - - -
Plus, INSTITUTIONS a/o *9-30-17: 9,420,098sh. = 20.9% <=*incl. Tappan’s 11-13-17/13G
...8,375,487 + 1,044,611(Tappan adds after 9-30-17) = 9,420,098
http://www.nasdaq.com/symbol/pphm/institutional-holdings
TOP13:
Tappan St. Partners 3,915,611 +2,259,359 <=per 11-13-17/13G(see below**)
Vanguard Group 1,518,110 +488,355
Blackrock (Larry Fink) 761,302 -44,720
Bandera Partners 555,000 +351,996
Renaissance Technologies 547,190 +66,030
Geode Capital Mgt. 225,676 -3
Fondren Mgt. 205,000 NEW
Stifel Financial 204,305 +200,762
Eqis Capital Mgt. 143,595 -6,804
Wells Fargo & Co. 117,829 +69,488
Connor Clark & Lunn 98,772 NEW
Brown Advisory Sec. 82,858 -1
Pdt Partners 82,800 NEW
And this big Q3 drop:
#18 Kennedy Capital Mgt. 69,820 -1,324,246
**11-13-17/13G: Tappan Street (Prasad Phatak) http://tinyurl.com/y85pz4fs
2 Funds + P.Phatak’s personal shares:
...Partners LLC, Tappan St. Fund L.P. 1,540,000 0
...Tappan St. Partners Ideas Fund L.P. 2,289,504 +1,597,927 since 8-14-17
...Prasad Phatak (Principle Owner) 86,107 +19,000 since 8-14-17
Total TAPPAN: 3,915,611 (8.5%)
Note: Tappan Street (total) Holdings history:
a/o 3-31-17: 914,304
a/o 6-30-17: 1,656,252
a/o 8-14-17: 2,298,684 5.1% (of 45,069,188 O/S as of 7-11-17)
a/o 9-30-17: 2,871,000 6.4% (of 45,096,081 O/S as of 9-11-17)
a/o 11-6-17: 3,915,611 8.5% (of 45,096,081 O/S as of 9-11-17)
Final Qtly Inst. Holdings from Nasdaq:
3-31-17: 5,690,888
6-30-17: 6,834,425
9-30-17: 8,375,487
Tappan’s increase of +2,259,359 to 3,915,611 happened B4/11-7-17
See: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=136169316
KennedyCAP sold 1,324,246 (not 9.7mm) q/e 9-30-17. They went from 1,394,066 to 69,820. Recall, Nasdaq erroneously showed 9,758,459 at 6-30-17 due to missing the 1:7 RS eff 7-10-17.
http://www.nasdaq.com/symbol/pphm/institutional-holdings
11-13-17/13G: Tappan St. Partners adds 1,616,927sh, now 3,915,611 (8.5% of 45,096,081). Now 3rd largest, behind Ronin and E.Capital(K.Dart). Their +1,616,927 pickup is since 8-14-17; since 6-30-17, they've added +2,259,359.
Tappan St. Partners 3,915,611 +1,616,927 <=per 11-13-17/13G(see below**)
Kennedy Capital Mgt. 1,394,066 +146,842 6-30-17
Vanguard Group 1,029,755 +146,791 6-30-17
Blackrock (Larry Fink) 806,022 -49,433 6-30-17
Renaissance Technologies 481,160 +41,487 6-30-17
Geode Capital Mgt. 225,679 +20,319 6-30-17
Bandera Partners 203,004 New 6-30-17
**11-13-17/13G: Tappan Street (Prasad Phatak) http://tinyurl.com/y85pz4fs
2 Funds + P.Phatak’s personal shares:
...Partners LLC, Tappan St. Fund L.P. 1,540,000
...Tappan St. Partners Ideas Fund L.P. 2,289,504 +1,597,927 since 8-14-17
...Prasad Phatak (Principle Owner) 86,107 +19,000 since 8-14-17
Total TAPPAN: 3,915,611 (8.5%)
Note: Tappan Street (total) Holdings history:
a/o 3-31-17: 914,304
a/o 6-30-17: 1,656,252
a/o 8-14-17: 2,298,684 5.1% (of 45,069,188 O/S as of 7-11-17)
a/o 11-6-17: 3,915,611 8.5% (of 45,096,081 O/S as of 9-11-17)
Large/Sh.Holders(36%) & RONIN-PPHM HISTORY, upd/11-13-17: ASM=>1/18/18
PPHM announces ASM date of 1-18-18, to be held at Avid’s Myford Facility, Tustin. Holders of the company's common stock on Nov. 27, 2017, the record date, will be entitled to receive notice of and vote their shares at the 2017 ASM Meeting. (see below)
11-13-17 PR: http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=1048430
NOTE:
See below for full PPHM-RONIN History of PR’s, Letters, 13-D’s, Form4’s, and Proxy’s (sorted: newest=>oldest).
KNOWN UPCOMING:
~Dec11: FY'18Q2 (qe 10-31-17) Financials & Conf. Call - http://ir.peregrineinc.com/events.cfm
Dec11-15/Avid Booth #311: KNect365’s Antibody Eng. & Therapeutics Conf., SanDiego https://lifesciences.knect365.com/antibody-engineering-therapeutics
Jan18: Peregrine's Annual Shareholder’s Meeting – 11-13-17/PR: http://tinyurl.com/y9tdcob5
= = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
10-27-17: Large Ownership Summary(35.7%) - now 16,113,738shs., 35.7% of 45,096,081 O/S at 9-6-17.
(Ronin+SW/Stafford+Farley+White, Eastern Cap./K.Dart, Institutions incl. Tappan’s 8-14-17/13G)
#1: 10-27-17/PR: Group Ronin Trading/SWInvest (John Stafford III+R.Farley+Stephen White) now has 9.6% stake (4,325,889sh.) in PPHM
...4,173,391 COMMON – 9.3% of 45,096,081 common O/S at 9-6-17 (total beneficial=4,325,889 if Pref. conv. x1.1905 to Common)
...128,099 PREFERRED – 7.8% of 1,647,760 preferred O/S at 7-31-17
NOTE: ALL historical common #’s adjusted for the 1:7 R/S eff. 7-10-17.
#2: 10-30-15: Kenneth Dart (Eastern Capital) acquires 9.5% stake (4,300,992sh.) in PPHM http://tinyurl.com/y95yskck
...3,777,183 COMMON – 8.4% of 45,096,081 common O/S at 9-6-17 (total beneficial=4,300,992 if Pref. conv. x1.1905 to Common, 9.5%)
...440,000 PREFERRED – 26.7% of 1,647,760 preferred O/S at 7-31-17
…...9-29-17/Form4: http://tinyurl.com/y9oadloa <=No chg. In Ownership; status update?
RONIN/SW 13D SUMMARY:
13D TransDates COMMON-CHG PREF-CHG ENDING-COMMON ENDING-PREF.
3-2-17 1/20/17-3/1/17 +2,947,425 +51,364 2,947,425 51,364 http://tinyurl.com/jr42u23
3-10-17 3/2/17-3/9/17 +433,509 +25,661 3,380,934 77,025 http://tinyurl.com/ydxra96u
4-17-17 3/28/17-4/10/17 0 +23,334 3,380,934 100,359 http://tinyurl.com/lanjddc
5-19-17 5/1/17-5/17/17 0 +23,140 3,380,934 123,499 http://tinyurl.com/mgnn92x
6-20-17 3/10/17-6/16/17 +378,170 0 3,759,105 123,499 http://tinyurl.com/y76q5rqu
6-29-17 6/21/17 +7,143 0 3,766,248 123,499 http://tinyurl.com/y9sp8bfv
7-14-17 6/29/17-7/7/17 +34,891 +3,600 3,801,139 127,099 http://tinyurl.com/ybra4s69
8-29-17 8/4/17-8/15/17 +27,252 0 3,828,391 127,099 http://tinyurl.com/yay55u3p (14A)
10-10-17 8/16/17-10/10/17 +45,000 0 3,873,391 127,099 http://tinyurl.com/ybvkjd3e (14A)
10-17-17 10/13/17-10/16/17 +109,573 +1,000 3,982,964 128,099 http://tinyurl.com/y983myco
10-27-17 10/17/17-10/27/17 +190,427 0 4,173,391 128,099 http://tinyurl.com/y7hslequ (14A)
SPLITOUT 13D GROUP into Ronin(John Stafford III, R.Farley) & SW-Partners(Stephen White):
Ronin Trading (Stafford) 3,173,391 115,299 (beneficial=3,310,652)
Ronin’s Roger Farley 300,000 1,000 (beneficial=301,190)
SW-Partners (White) 700,000 11,800 (beneficial=714,047)
- - - - - - - - - - - - - - -
Plus, INSTITUTIONS a/o 6-30-17: 7,476,857sh. = 16.6% <=incl. Tappan’s 8-14-17/13G,
...and KennedyCAP corrected 9,758,459=>1,394,066(Nasdaq R/S error)
...15,198,818 +(1,394,066-9,758,459) + (2,298,684-1,656,252) = 7,476,857
http://www.nasdaq.com/symbol/pphm/institutional-holdings
TOP7:
Tappan St. Partners 2,298,684 +1,384,380 <=per 8-14-17/13G(see below**)
Kennedy Capital Mgt. 1,394,066 +146,842
Vanguard Group 1,029,755 +146,791
Blackrock (Larry Fink) 806,022 -49,433
Renaissance Technologies 481,160 +41,487
Geode Capital Mgt. 225,679 +20,319
Bandera Partners 203,004 New
**8-14-17/13G: Tappan Street (Prasad Phatak) http://tinyurl.com/ybgqp9uq
2 Funds + P.Phatak’s personal shares:
...Partners LLC, Tappan St. Fund L.P. 1,540,000
...Tappan St. Partners Ideas Fund L.P. 691,577
...Prasad Phatak (Principle Owner) 67,107 Total TAPPAN: 2,298,684 (5.1%)
Note: Tappan Inst. Holdings a/o 3-31-17 was: 914,304, 1,656,252 at 6-30-17.
ATM’s 2/1/17–6-/30/17 were 43,322,960sh. raising $23,640,000 (.42=>2.94postRS).
Immediately prior to that (12/13/16-1/31/17), 13,926,930sh. were ATM’d raising $4,308,000 (.31=>2.17postRS).
See: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=136003049
BTW, the 8-29-17 Ronin 14A proxy, lists this as the initial “event” leading up to “this proxy solicitation”:
“On Jan. 17, 2017, Stephen White visited Peregrine’s offices in Tustin, California for a facility tour and also met with certain members of the Company’s mgt. team, including President/CEO/Dir. Steven W. King and CFO Paul J. Lytle.”
http://tinyurl.com/yay55u3p
SITC’17(Nov8-12) Abstracts released (Sunrise, PPHM+MSKCC/preclin)…
Nov8-12 2017: “(SITC) Society for Immunotherapy of Cancer 32nd Annual Meeting”, Natl-Harbor MD
”The premier destination for scientific exchange, education, and networking in the Cancer Immunotherapy Field”
SITC = The Society for Immunotherapy of Cancer http://www.sitcancer.org
SITC 2017 Meeting: http://www.sitcancer.org/2017/home
Abstracts: http://www.sitcancer.org/2017/abstracts All abstracts submitted to the SITC 32nd Annual Meeting will be published in the Journal for ImmunoTherapy of Cancer (JITC), the official journal of SITC. Regular abstracts will be published on Nov7 & LBA's will be pub. on Dec7.
= = = = =PPHM/MSKCC:
1. #P87: “Results of Epigenetic-Based Quantitative PCR Assisted Immune Cell Counting Analysis in Bavituximab SUNRISE Trial Subgroup”
https://www.sitcancer.org/2017/abstracts/titles/biomarkers-immune-monitoring
Nikoletta L. Kallinteris 1, Thomas O. Kleen 2, Min Tang 1, Shen Yin 1, Tobi Guennel 3, Jennifer Lai 1, Victor Nowakowski 2, Steven Olek 2, Steve King 1, Joseph S. Shan 1
1 Peregrine Pharmaceuticals
2 Epiontis GmbH, Berlin, Germany
3 Precision Medicine, Frederick MD
SITC’17 #P87 ABSTRACT:
BACKGROUND
SUNRISE (NCT01999673 https://www.clinicaltrials.gov/ct2/show/NCT01999673 ), a global, double-blind, randomized Phase III trial of docetaxel bavituximab (D+B) or docetaxel+placebo (D+P) in previously treated non-squamous NSCLC, demonstrated similar OS in the intent-to-treat population (n=597). In the subgroup of 93 pts who received subsequent Immune Checkpoint Inhibitors (ICI), mOS was not reached (95%CI, 15.2-NA) in the D+B group (n=46) and was 12.6 mos. (95%CI, 10.4-17.8) for patients in the D+P group (n=47) (HR for death, .46; P=.006). Epigenetic-based quantitative real-time PCR assisted cell counting (qPACC) of immune cells in blood was used to potentially identify predictive biomarkers.
METHODS
DNA was isolated from peripheral blood mononuclear cells (PBMC) from randomized ptss and treated with bisulfite leading to conversion of de-methylated cytosine (epigenetically active) residues into uracil, but left methylated ones unaffected. The de-methylation status of DNA regions, previously identified of being specific to respective immune cell phenotypes sorted by FACS: CD3+, CD4+, CD8+, TFH, TH17, PD1, Foxp3, naive CD8, MDSC, CD14+, NK56+, B-cells, GNLY, and CCR6+, was quantitated by qPACC. The number of de-methylated gene copies per biomarker was quantitated and translated into % total of cells in the sample. Each biomarker was classified as high or low based on the median value across all pts and correlated to OS. Hazard ratios (HR) and confidence intervals (CI) were estimated using a Cox proportional-hazards model.
RESULTS
Pre-treatment (pre-tx) samples were evaluable by qPACC for 62 (32 D+B, 30 D+P) out of the 93 pts who received ICI as next line therapy after the SUNRISE assigned treatment. High pre-tx (>=median) levels correlated with statistically significant OS benefit favoring D+B for the following biomarkers: CD3+ (HR=.37, p=.023), CD4+ (HR=.32, p=.012), CD8+ (HR=.42, p=.036), PD-1 (HR=.33, p=.017), GNLY (HR=0.25, p=.011), FoxP3 (HR=.34, p=.032), naïve CD8+ (HR=.32, p=.034), B-cells (HR=.24, p=.007), MDSC (HR=.33, p=.037) NK56+ (HR=.29, p=.026). Low (<) pre-tx levels of THF correlated with OS favoring D+B (HR=.34, p=.033). No OS difference was observed for pre-tx high or low levels for TH17, CCR6, or CD14+.
CONCLUSIONS
High pre-tx levels (>=median) of circulating immune cells including T cells, B-Cells, MDSCs, NK cells correlated with significant improvement of OS in patients who received D+B then ICI compared to D+P then ICI in the SUNRISE trial. These results support further investigation of these markers in future bavituximab clinical trials
- - -
ALSO SEE: Sunrise Biomarkers (#1/B2GPI #2/COMPL,IL10 #3/IFN-y #4/PD-L1), upd. ASCO’17
… http://investorshub.advfn.com/boards/read_msg.aspx?message_id=131946387
2. #P262: “Phosphatidylserine Targeting Antibody In Combination With Tumor Radiation & Immune Checkpoint Blockade Promotes Anti-Tumor Activity in Mouse B16 Melanoma”
https://www.sitcancer.org/2017/abstracts/titles/combination-therapy
Sadna Budhu 1, Rachel Giese 1, Olivier De Henau 1, Roberta Zappasodi 1, Luis Felipe Campesato 1, Aditi Gupta 1, Christopher Barker 1, Bruce Freimark 2, Jedd D. Wolchok 1, Taha Merghoub 1
1 Memorial Sloan Kettering Cancer Center, NYC
2 Peregrine Pharmaceuticals, Inc.
SITC’17 #P262 ABSTRACT:
BACKGROUND
Phosphatidylserine (PS) is a phospholipid that is exposed on surface of apoptotic cells, viable tumor cells, tumor endothelium and activated immune cells. It has been shown to promote immunosuppressive signals in the tumor microenvironment. In a mouse B16 melanoma model, targeting PS in combination with immune checkpoint blockade promoted greater anti-tumor activity than either agent alone. This combination was shown to enhance CD4+ and CD8+ T cell infiltration and activation in the tumors of treated animals. Radiation therapy (RT) is an effective focal treatment of primary solid tumors, but is less effective in treating metastatic solid tumors as a monotherapy. RT induces immunogenic tumor cell death and enhances tumor-specific T cell infiltration in treated tumors. The abscopal effect, a phenomenon in which tumor regression occurs outside the site of RT, has been observed in both preclinical and clinical trials when RT is combined with immunotherapy.
METHODS
Mice were injected intradermally on the hind limb with 10^5 B16F10 melanoma cells. 7-10 days after implantation, tumors were treated locally with 15 Gy RT. 1 day after RT, mice were given antibodies to PS (mch1N11) [mouse chimeric/bavituximab] and PD-1 (RMP 1-10) intraperitoneally every 3 days. Tumor surface area and overall survival of mice were used to determine efficacy of the combinations. For FACS analysis, tissues were collected between 1-10 days after RT.
RESULTS
In this study, we show that irradiation of B16 melanoma causes an increase in PS expression on the surface of viable tumor and immune infiltrates. We subsequently examined the effects of combining RT with an antibody that targets PS and anti-PD-1. We found that treatment with mch1N11 synergizes with RT to improve anti-tumor activity and overall survival in tumor bearing mice. In addition, the triple combination of mch1N11, RT and anti-PD-1 treatment displayed even greater anti-tumor and survival benefit. Analysis of the immune response in the tumors of treated animals revealed an increase in M1-like macrophages in the tumors after treatment with RT and mch1N11. In addition, analysis of the systemic immune responses revealed an increase in antigen-specific CD8 T cell infiltration in the tumors as well as increased activation, effector function and differentiation in the triple combination therapy.
CONCLUSIONS
This finding highlights the potential of combining these agents to improve outcome in patients with advanced-stage melanoma and may inform the design of future clinical trials with PS targeting in multiple cancers.
= = = = = = = = = =
NOTE:
This same titled joint PPHM+MSKCC poster was presented twice before (to what extent has the content chgd. w/author chgs?):
A. 11-11-16/SITC’16 http://tinyurl.com/js3fca4 MSK: Sadna Budhu, Olivier De Henau, Roberta Zappasodi, Christopher A. Barker, Jedd Wolchok, Taha Merghoub; PPHM: Kyle Schlunegger, Bruce Freimark, Jeff Hutchins
B. 4-2-17 at AACR’17 http://tinyurl.com/lxlltd6 MSK adds: Rachel Giese, Luis F. Campesato; PPHM drops: K.Schlunegger
C. Nov’17/SITC’17: MSK: adds Aditi Gupta; PPHM: drops J.Hutchins
- - - - - -
Peregrine began working w/Mem-Sloan-Kettering(Jedd Wolchok Lab) in Jul'15 (2 known studies a/o 4-2017: #1/Bavi+PD1+Rad, #2/Bavi+”ACT”) to investigate “Novel PS-Targeting Immunotherapy Combos”. See: http://tinyurl.com/lxlltd6
ALSO SEE: PPHM/MSKCC(Jedd Wolchok Lab) Collab: #1/Bavi+PD1+Rad, #2/Bavi+”ACT”, upd. AACR’17
… http://investorshub.advfn.com/boards/read_msg.aspx?message_id=130490016
Actually those are for 12-8-17 thru 4-30-17. Here is for 2-1-17 – 6-30-17:
The ones BOLD’d:
10-31-16: 251,765,279 +9,383,429 (10-31-16 10Q iss. 12-12-16)
12-8-16: 257,141,534 +5,376,255 (“ “ “)
1-31-17: 271,068,464 +13,926,930 (1-31-17 10Q iss. 3-13-17)
3-10-17: 297,709,478 +26,641,014 (“ “ “)
4-30-17: 44,014,040(x7)=308,098,280 +10,388,802 (4-30-17 10K iss. 7-14-17)
7-10-17: 1:7 R/S (~315mm/$.606=>~45mm/$4.24) http://tinyurl.com/ycohqn6j
7-10-17: 45,069,188 +1,055,148 (“ “ “) <= 7,386,036 pre-split.
7-31-16: 45,094,154 +24,966 (7-31-17 10Q iss. 9-11-17)
8-25-17: 45,096,081 +1,927 (8-25-17 Amended 10K http://tinyurl.com/yb5jq7vc )
9-6-17: 45,096,081 nochg (7-31-17 10Q iss. 9-11-17)
PS:
For analyzing ATM’s usage, better to look at the ATM section:
...During 2-1-17 – 6-30-17, 43,322,960 ATM Sold (pre-split obviously).
VI. MLV 8-2015: “Aug’15 AMI Agreement – up to $30mm” http://www.mlvco.com
Form 424B5 filed 8-7-15: http://tinyurl.com/oc53ugn
• Sold 8/7/15-9/9/15: $892,000gr. / 1,091,000sh. = $1.18/sh.
• Sold 9/10/15-10/31/15: $4,294,000gr. / 4,059,478sh. = $1.06/sh.
• Sold 11/1/15-12/10/15: $2,261,000gr. / 1,939,413sh. = $1.17/sh.
• Sold 12/11/15-1/31/16: *NO ATM SALES*, per 1-31-16 10Q iss. 3-9-16
• Sold 2/2/16-4/30/16: *NO ATM SALES*, per 4-30-16 10Q iss. 7-14-16
• Sold 5/1/16-7/14/16: $937,000gr. / 1,876,918sh. = $.50/sh.
• Sold 7/15/16-9/8/16: *NO ATM SALES*, per 7-31-16 10Q iss. 9-8-16
• Sold 9/9/16-10/31/16: $2,513,000gr. / 6,432,439sh. = $.39/sh.
• Sold 11/1/16-12/12/16: $1,174,000gr. / 3,788,346sh. = $.31/sh.
• Sold 12/13/16-1/31/17: $3,404,000gr. / 11,069,646sh. = $.31/sh.
• Sold 2/1/17-3/13/17: $7,335,000gr. / 15,308,300sh. = $.48/sh.
• Sold 3/14/17-4/30/17: $2,883,000gr. / 4,486,182 = $.64/sh.
• Sold 5/1/17-6/30/17: $4,307,000gr. / 7,358,806 = $0.59/sh.
. . .Before 7-10-17 1:7RS: $30,000,000gr. / 57,072,288 = $.53/sh.
. . .After 7-10-17 1:7RS: $30,000,000gr. / 8,153,184 = $3.68/sh.
VII. NOBLE 8-2015: “Aug’15 Eq.Dist. Agreement – up to $20mm” http://www.noblelsp.com
Form 424B5 filed 8-7-15: http://tinyurl.com/yazonjyw
• Sold 11/1/15-12/10/16: $2,371,000gr. / 1,925,844sh. = $1.23/sh.
• Sold 12/11/15-1/31/16: $2,857,000gr. / 2,529,434sh. = $1.13/sh.
• Sold 2/1/16-4/30/16: $1,741,000gr. / 4,017,010sh. = $.43/sh.
• Sold 5/1/16-7/14/16: $1,233,000gr. / 2,649,318sh. = $.47/sh.
• Sold 7/15/16-9/8/16: *NO ATM SALES*, per 7-31-16 10Q iss. 9-8-16
• Sold 9/9/16-10/31/16: $1,283,000gr. / 2,988,086sh. = $.43/sh.
• Sold 11/1/16-12/12/16: $496,000gr. / 1,587,909sh. = $.31/sh.
• Sold 12/13/16-1/31/17: $904,000gr. / 2,857,284sh. = $.32/sh.
• Sold 2/1/17-3/13/17: $6,006,000gr. / 11,273,296sh. = $.53/sh.
• Sold 3/14/17-4/30/17: $3,109,000gr. / 4,896,376sh. = $.63/sh.
. . .Before 7-10-17 1:7RS: $20,000,000gr. / 34,724,557 = $.58/sh.
. . .After 7-10-17 1:7RS: $20,000,000gr. / 4,960,651 = $4.03/sh.
See: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=134681828
iBox ARCHIVES: 2010–2012 (linkable from within iBox)
...iBox: http://investorshub.advfn.com/boards/show_ibox.aspx?boardid=2076
In 3 sections, paralleling iBox’s organization:
I. COMPANY NEWS (Articles, Annual SHM’s, & CC’s)
II ANTI-CANCER NEWS (trials in sep. Archive)
III. ANTI-VIRAL NEWS (trials in sep. Archive)
. . . .All History of the 2008-2011 DTRA-Govt $24.7mm Contract
. . . .All History of the & Duke/PPHM/ HIV preclin. collab.
. . . .All OTHER Anti-Viral News
============================================================
I. COMPANY NEWS ARCHIVES (Articles, Annual SHM’s, & CC’s) – 2010-2012
12-10-12 Qtly. Conf. Call (King/Garnick/Shan/Lytle) Transcript http://tinyurl.com/a954bmw
...CEO Steve King: "The goal of this (2nd-Line NSCLC ) review is to be able to generate a final data set that we believe could be used in discussions with the FDA to support advancing the program into a pivotal trial. Our partnering phase for Bavi has not changed. The partnering discussions are still ongoing, with potential partners remaining engaged, and like all of us, awaiting the outcome from this review…"
...Rob Garnick (Head/Reg.): "(Re: Cotara FDA-Approved Ph3 Design), we're pivoting right now and following the discussions with the FDA to discuss the same trial design plan with the Eur. agency and as well as potentially other global regulatory authorities. So, it's going to take a lot of effort and a lot of time, but we're very confident that we're going to be able to come up with one unified trial that will accomplish all of our goals."
10-17-12: Corp-Update ($14.3mm/ATM, Avid, Mult-Milestones, ASM Webcast Oct18) http://tinyurl.com/c7gax7y
…PDF of 10-18-12 ASM Presentation/S.King http://tinyurl.com/8e5p6m5 (19 slides), Attendee Reports: http://tinyurl.com/9b2xfzu
9-24-12: Peregrine sues CSM Over Bavi Ph.2B 2nd-Line NSCLC Clinical Trial Mix-Up http://tinyurl.com/8fpgngu
…CSM = Clinical Supplies Management Inc., Fargo ND http://www.csmondemand.com
9-25-12: Peregrine Pays Off $15mm Loan from Oxford, triggered by 3rd-party data error: http://tinyurl.com/9pucqn8
……"we will have sufficient capital to fund our operations into Q4'13 based on current projections."
...8-30-12: $30mm Loan ($15mm/immed, $15mm/option) from Oxford Fin. http://tinyurl.com/cm2lkgs 8K: http://tinyurl.com/9hedbaf
9-2012 PPHM's 2012 Annual Report: Theme => "Transformation" http://tinyurl.com/8myww6w
9-10-12 Qtly. Conf. Call (King/Shan/Garnick/Lytle) Transcript http://tinyurl.com/8nkwrml
...CEO Steve King: "These are truly remarkable results that are not only great for the pgm… but also great news for the NSCLC patients in the trial…"
...Rob Garnick (Head/Reg.): "The NSCLC data we announced 9-7-12 has far exceeded our expectations, and I hope that you're as excited as I am with bavituximab's potential. I feel strongly that Peregrine should be recognized for having the corporate courage to conduct the rigorous, randomized placebo-controlled Phase II trial that provided these robust data and that provide the basis for us to plan for a pivotal Phase III program.."
...CFO Paul Lytle: "As you can imagine, given the Bavi results that we shared with you on Friday [9-7-12 2nd-Line NSCLC], our partnering activities are continuing at a very active pace as we move closer towards the EOP2 meeting with the FDA. Our stated goal is to have a partner on board before we start the Phase III trial and, preferably, before the EOP2 meeting with the FDA, as we would like our future partner to be a part of that important meeting.”
9-5-12: CEO Steve King's 26min. talk at Stifel-Nicolaus/Boston http://tinyurl.com/cr65pug
8-30-12: $30mm Term-Loan Secured ($15mm/immed, $15mm/option) + 273k 6yr warrants@2.47 http://tinyurl.com/cm2lkgs 8K: http://tinyurl.com/9hedbaf
8-15-12: CEO Steve King's 29min. talk at Wedbush/NYC http://tinyurl.com/8mhrtld
…SK: "As we're sitting here today, we have still not reached MOS in either of the Bavi arms in the 2nd-Line NSCLC trial - and, in fact, we still have patients that are on treatments." Q&A: "it's going to be a very positive MOS result, it's just a matter now of magnitude. We've laid out our strategy for financing the company; we've not been raising money thru the capital markets in any way. We're not currently planning on going out for, nor have we been actively involved in any other fund-raising activities. Right now, our stated goal is to pursue a debt-arrangement - with an asset like Avid Bioservices, we can get very preferential rates on raising debt-type funding right now, which we feel is the least-dilutive for the company."
7-16-12 Qtly. Conf. Call (King/Shan/Garnick/Lytle) Transcript http://tinyurl.com/cs7spbz
...Steve King: "The strength of this 2nd-Line NSCLC data (esp. MOS trends) in this large area of high unmet medical need has also sparked a surge in partnering discussions that has included over 15 in-person partnering meetings since that time with major players in oncology, with all discussions ongoing and addl. parties showing interest. Our goal for the program is to position ourselves, along with a potential partner, to initiate Ph3 by mid-2013, which means an EOP2 meeting by yr-end'12. It would be ideal to have a partner on board to participate in the EOP2 meeting, and we have communicated this to interested parties and they agree."
...Robert Garnick: "We've been working very hard and very actively on the next steps in our Bavi 2nd-Line NSCLC pgm, given the favorable data that we've seen. As you can imagine, with data like this, there are many things that we need to consider. One consideration is that, should the data continue to trend the way it is, particularly in survival, this opens a door for potential discussions around a pathway for ACCELERATED APPROVAL. At this point, all options are being considered, with Peregrine working towards the most efficient path forward from a regulatory standpoint." Q&A: "…all in all, I think the data is extremely compelling and I think it makes a really good case. Certainly, I think, I've seen a lot of Ph2 & Ph3 data, and this is as compelling Ph2 data as I've ever seen. So, I'm very comfortable proposing a meeting with the FDA for Q4'12."
7-12-12: CEO Steve King's 26min. talk at JMP/NYC http://tinyurl.com/csdclwb
…SK: "Re: 2L/NSCLC trial, the most thrilling thing is the fact that, even though we had reached the MOS by the cutoff point at the end of April of less than 6mos. for the Doce ctl-arm, the majority of patients are still alive in both Bavi arms, and we expect that to continue for some period of time still."
6-20-12: PPHM hires Securities, Financing, and M&A Attorney Mark Ziebell as VP, General Counsel http://tinyurl.com/7ze229a
3-12-12: CEO Steve King's 24min. talk at ROTH-OC(DanaPT) http://tinyurl.com/7837qym
…SK: "I think the best-case result is, if we have just phenomenal results out of this study (2ndLine-NSCLC), that we would obviously talk to the FDA about Accelerated Approval; that was our intention to begin with."
3-9-12 Qtly. Conf. Call (King/Shan/Garnick/Lytle) Transcript http://tinyurl.com/7t2xsks
…Rob Garnick, "re: 1st-Line NSCLC, I personally don't read a lot into ORR data nor PFS and really go for the std. that really counts that's unequivocal & relatively straightforward to measure, which is MOS, and I think we have to wait for those results in order to make any judgment. And on top of that, I'd like to point out that our primary goal is in 2nd-line NSCLC, which is a disease with very low response rates in general (10% or 11%), and what we're expecting to show there is a real increase ultimately in survival. And, if we see that, that's what we'll take forward into a Phase III pivotal trial."
2-14-12: CEO Steve King's 24min. talk at BIO-CEO/2012 (NYC) - slides & excerpts http://tinyurl.com/86wque8
…SK: "Our pipeline is completely unencumbered, so as we look into 2012 & beyond, we think we can bring in significant monies thru partnering deals which will help us move the programs forward."
12-12-11 Qtly. Conf. Call (King/Shan/Lytle) Transcript http://tinyurl.com/75rfwrv
…SK, "Our goal is to secure regional partners for our Bavi oncology program, and we look forward to seeing addl. data points from our randomized trials as we advance these discussions. [re: Cotara/GBM Ph3], the FDA has agreed to provide specific feedback to us in writing on our proposed pivotal trial design that we submitted to them."
9-27-11: JMP Securities Healthcare Conf./NYC - SK's Slideshow Capture http://tinyurl.com/3qqslkb
9-9-11 Qtly. Conf. Call (King/Garnick/Shan/Lytle) Transcript http://tinyurl.com/3bx8eat
...Robert Garnick: "As we saw over the last couple of weeks, the most recently approved therapy for NSCLC drugs (Pfizer's crizotinib=Xalkori) can in fact receive Accelerated Approval based on ORR data gen'd from single-arm studies, and we're very eager to assess bavituximab's potential in our ongoing trials."
9-8-11: CEO Steve King presents at Stifel Nicolaus HC/Boston - a few slides, incl. milestones: http://tinyurl.com/3sk8rba
7-14-11 Qtly. Conf. Call (King/Shan/Garnick/Masten/Eso/Lytle) Transcript http://tinyurl.com/6k6y2as
...Robert Garnick: "It's really easier to approach regulatory agencies with promising survival data and a consistent safety profile, which is exactly what we have seen from both bavituximab & Cotara in our clinical trials to date."
6-29-11 Minyanville article, "Peregrine Pharma's Secret Weapon [Robert Garnick]" http://tinyurl.com/3lgoras
…CEO Steve King considers his company fortunate to have someone with Garnick's long history with the FDA. "Rob is the ringmaster," King says.
11-8-11: April Loui (ex-Genentech Sr.Mgr/QA) joins Peregrine as Director/QA http://tinyurl.com/6tzbfkt
5-31-11: Jeff Masten (ex-Genentech Sr.Dir. of Quality) joins Peregrine as VP/Quality http://tinyurl.com/3qxuvso
..."This is an exciting time to join Peregrine, as bavituximab advances through numerous Phase II clinical trials and Cotara's registrational path is being outlined. I look forward to working with CEO Steve King, head of regulatory affairs Rob Garnick, and the extended teams at Peregrine and Avid to drive industry-leading quality programs and facilitate regulatory agency inspections as we support Avid's third-party clients and prepare for potential launch of Peregrine's products."
5-26-11: Dr. Steven Chamow (ex-Genentech) joins Peregrine as Head of Process Science http://tinyurl.com/3bgglxj
5-19-11: Nuclear-Med. & Oncology Specialist Dr. Vladimir Evilevitch (ex-Parexel, ex-Novartis) joins PPHM as Med.Director http://tinyurl.com/3av4red
…"to execute Cotara Regulatory & Clinical strategy"
4-2011: Peregrine adds 2 more "Regulatory" people, Kathryn Hansen (ex-Amgen) & Soheila Dadgostari (ex-Valeant) http://tinyurl.com/3wy4sxm
3-14-11: S.King at Roth-OC/DanaPT - slides & excerpts: http://tinyurl.com/4d2voyy
...SK: "Cotara/GBM Ph.2/40pt enrollment completed in Dec'10; expect top-line by mid'11, We've already begun preparing for an FDA meeting in 2H'11, in which the goal is to get an SPA ("Special Protocol Assessment") approved; at that point, the drug is highly partnerable." [Per David Miller, "the idea is if you sign an SPA with the FDA and conduct the trial as agreed, good results from the trial will be sufficient for marketing approval."]
3-11-11 Qtly. Conf. Call (King/Shan/Thorpe/Lytle) Transcript http://tinyurl.com/4p4hqr5
3-9-11: Dr. Kerstin B. Menander (ex-Abbott) appointed Head of Medical Oncology http://tinyurl.com/4cjlbzn
3-4-11: Reuters' Deena Beasley Interviews Steve King http://tinyurl.com/4c9um52
...SK: "The study [ongoing Ph.2b Bavi+Doce/Refract-NSCLC] could provide the basis for seeking U.S. regulatory approval… This is easily a $1B+ potential drug in NSCLC alone."
12-9-10 Qtly. Conf. Call (King/Shan/Eso/Lytle) Transcript http://tinyurl.com/23kassc
…S.King: "our next planned virus therapy trial will evaluate Bavi+Ribavirin vs. HCV patients… we are planning to initiate addl. Co-sponsored trials & ISTs in the very near future."
11-2-10: Peregrine Awarded $977,917 Therapeutic Discovery Grant http://tinyurl.com/2funn26
10-21-10: Carlton Johnson appointed Chairman of BOD & SHM Results http://tinyurl.com/269zqn5
10-3-10/OCBJ: PPHM Repeats as #1 Growth Co. in OrangeCo. http://tinyurl.com/27cuv7o
...Last-12mos-Rev: $27.9mm, 3yr-Sales-Growth: +358.6%
9-13-10, CEO S.King, R&R/NYC: http://tinyurl.com/23fagxw
…S.King re:TMT: "We're at the point where we're getting into more advanced models of the disease, as well as starting to look at some combination-therapy potential of the drug. The plan now is to complete that evaluation, to firmly establish that pgm going forward - then at that point it'll be a contract modification, and from everything we hear, we s/b moving fwd with addl. animal studies."
9-9-10 Qtly. Conf. Call (King/Eso/Lytle) Transcript http://tinyurl.com/8megkre
…S.King: "[On the AV side], so far every type of virus we have looked at does induce PS exposure on infected cells. And that creates a vast number of opportunities, everything from immunocytokines, which we're currently evaluating as part of our UC Discovery grant work, all the way to targeting nanoparticles, in which you could basically take these nanoparticles, load them with different antivirals depending on the particular type of antiviral indication, and specifically deliver your drugs to the infected cells, reducing the toxicity of the agent and taking advantage of our technology platform. And, there's actually interest in all of those from both funding agencies as well as potential partners down the road. So, I think there's a lot of great utility of that technology platform and the group here is looking at a number of different areas that we really think have pretty dramatic potential from a market standpoint, but also just can build & build on what really is a platform that has so much utility."
9-7-10 PS Patents Granted: 7790860/Imaging 7790159/Antiviral http://tinyurl.com/27zlc8a
8-2010/IF LINKEDIN IS RIGHT: Dr. Shelley Suggett (ex-Genentech Sr.Product.Dir/Regulatory) joins PPHM as Director, Regulatory Affairs http://tinyurl.com/3lmw22s
7-14-10 Qtly. Conf. Call (King/Garnick/Shan/Eso/Lytle) Transcript http://tinyurl.com/3a4p66c
…Robert Garnick: "I like to end by again saying how optimistic I am about bavituximab's potential. The growing body of research points to bavituximab potentially providing a unique & valuable new approach for the treatment of cancer. The clinical results we have to date support moving forward with our regulatory strategy to advance this novel antibody."
6-14-10: PPHM set to join Russell 3000 - reconstitution occurs 6-28-10: http://tinyurl.com/2d87y3z
6-9-10 CFO Paul Lytle's 26min. talk at Needham HealthCare Conf./NYC http://tinyurl.com/2wt2gc7
...See slide5: considerable discussion of possible addl. Gov't Contracts & Grants, like new IRS "Therapeutic Discovery Proj. Pgm" (max=$5mm).
5-18-10: CEO Steve King's 20min. talk at R&R HealthcareConf/London http://tinyurl.com/23wqam9
…SK: "based on these [Bavi Ph.2] clinical data and our interactions with the FDA, we're in the process of operationalizing a Phase IIb Registrational Trial [Bavi+Doce 2nd-line NSCLC]. We're referring to this as a "registrational trial" because one potential is if we anywhere close to approximate the results we've seen in a prior study, this could be an opening for Accelerated Product Approval."
3-17-10: CEO Steve King's 23min. talk at ROTH Stock Conf. (DanaPT CA) http://tinyurl.com/ye9v7jq
…SK: "And then we have a real interesting part of the portfolio, which is our Bavi VHF pgm. This is completely funded by the DOD… evaluating Bavi for the treatment or prevention of VHF. What's interesting about this compound is this would not take a typical Phase1-2-3 approval approach, but rather likely go thru the FDA's "Animal Rule", which means that it basically would have animal efficacy data, combined with human safety data, which we're obviously generating a lot of, and then it would be applied for approval based on those 2 things. So this could be a much shorter entry point into an actual product that could be acquired by the gov't to stockpile as part of its biodefense efforts."
3-11-10 Qtly. Conf. Call (King/Lytle/Shan/Eso) Transcript http://tinyurl.com/yl4befh
…SK (resp. to Joe Pantginis question re: bus.dev. strategy for Bavi): "Clearly there is a lot of interest in the bavituximab pgm - novel monoclonal antibody therapies with an interesting target that has broad-spectrum capabilities in multiple indications - clearly there are not a lot of those out there… we have a lot of interested parties; we will continue to keep those potential partners updated on our clinical trial progress."
2-9-10: CEO Steve King's 23min. talk at BIO-CEO/2010 (NYC) http://tinyurl.com/ykxznha
…SK: "what we're most intrigued about is Bavi's potential in Refractory Disease, which of course is the fastest route to product approval."
1-13-10: CEO Steve King's 16min. talk at OneMedForum2010 (SanFran) http://tinyurl.com/yb7v2u4
…SK: "The [next] study we have discussed with the FDA is Bavi+Doce in 2nd-line NSCLC. In this patient population, they have about a 6% resp. rate; so, a high unmet medical need, and we think an excellent opportunity for development. The trial design we've agreed to with the FDA is essentially a registrational Ph.2 design; it's going to be about a 120 patient study, double-blinded, placebo-controlled… the goal being, if we see positive results & excellent results, that we really want to be able to take advantage of that and potentially approach the agency about Accelerated Approval."
1-11-10: Dr. Marvin Garovoy (Ex-XOMA VP) joins PPHM as Head/Clin.Science http://tinyurl.com/yz4fwyv
…Dr. Garovoy will have primary responsibility for establishing & supervising an Investigator-Sponsored Trials (IST) pgm, as well as expanding scientific outreach & assisting with clinical trial design for the Bavi & Cotara pgms.
…CEO SK: "These ISTs can be a very important part of our overall clinical dev. pgm, potentially providing invaluable info. that might not otherwise be obtained from our company-initiated trials."
…Dr. Garovoy, "Bavituximab is a promising new approach with broad potential for the treatment of solid cancers and other diseases. Based on the encouraging results seen in early clinical trials, I welcome the opportunity to collaborate with clinical researchers to establish the investigator-sponsored studies that will enhance our understanding of the clinical potential of this exciting new agent."
ARTICLES, ANNUAL SHM'S, & CC'S - Archive 2005-2009: http://tinyurl.com/6pjqt27
============================================================
II. ANTI-CANCER NEWS ARCHIVES (2010-2012)
10-31-12, New PS-Targeting Preclin. Data - Mabs Stimulate Cancer-Fighting Immune Responses & Specifically Target Tumors http://tinyurl.com/cw9odb8
…10-25-12 SITC Poster describes Bavi's 3-pronged MOA, and 10-10-12 Nuclear Medicine & Biology article on "ImmunoPET Imaging of PS" using 89Zr-PGN635.
8-2-12: Texas CPRIT grants Philip Thorpe $1.4mm in $4.1mm Lung Cancer Project (SRBT/Rad+AntiPS) http://tinyurl.com/clhzbx2
. . .Dr. Thorpe's Project4 "Lay Summary" => http://www.cprit.state.tx.us/files/funded-grants/RP120670-P4.pdf
5-1-12 Audio replays of the NYAS Anti-PS Symposium (NYC) now at NYAS.org: http://tinyurl.com/7w3kpuc
…The 5 Speakers were: Alan Schroit, David Ucker, Ari Helenius, Chris Reutelingsperger, Philip Thorpe => Dr.Thorpe's 46min talk: http://tinyurl.com/d6vtsrr
4-2012: UPenn & Dr.Thorpe Neoplasia article on PGN635 vs. Lung Cancer http://tinyurl.com/7dynlzr
…on the potential benefits of treating with fhBavi+Chemo (PGN635+cis) AFTER Surgery - an approach offering "significant promise to prevent lung cancer recurrences."; also contrasts Bavi vs. Avastin on side effects.
4-2012 AACR'12: 7 Posters (3 Bavi/IST's, 3 Bavi/antiPS pre-clin, 1 TNT-Imaging) http://tinyurl.com/7yrwqm7 (see #2452)
…Peregrine Launches PS-Targeting Clinical Imaging Pgm. (fully-human 124I-PGN650), IND recently filed.
8-2011: Gerber/Thorpe IMMUNOTHERAPY article on Bavi+Chemo/NSCLC http://tinyurl.com/3gzd6g5
...Obviously resulting from: 6-10-09 ASCO $200k Grant to UTSW's David Gerber for New Bavi/NSCLC Study: http://tinyurl.com/nt4na9
6-2011 Dr. Philip Thorpe article in VACCINE on the "Anti-PS Fusion Protein" 2aG4-IL2: http://tinyurl.com/3o6aq7p
…"Enhancing The Potency of a Whole-Cell Breast Cancer Vaccine in Mice with an Antibody-IL-2 Immunocytokine that Targets Exposed PS"
5-26-11: Dr. Philip Thorpe Keynotes Bavi/PS MOA at Recombinant-Antibodies Conf. in Barcelona http://tinyurl.com/3klpodc
…Dr. Thorpe, "What is especially exciting is that administration of PS-targeting antibodies like bavituximab breaks the grip of the tumor on the immune system."
...A few of the more illustrative slides from Dr. Thorpe's 5-26-11 talk: http://tinyurl.com/3m33h33 . . .PT's entire 53-pg PDF: http://tinyurl.com/3ck56gr
4-5-11 AACR'11 #3643: Sorafenib Enhances Anti-tumor Effects of Bavi in Liver Cancer (HCC) http://tinyurl.com/3fzubz3
…Dr.Thorpe: "These data suggest that the growth-blocking mechanisms of sorafenib combined with the vascular-targeting & immune-reactivation mechanisms of bavituximab may offer additive anti-tumor effects for patients with HCC."
4-6-11 AACR'11: Peregrine's 4 PS-Targeting Presentations http://tinyurl.com/68p9zs4
…#621/ADT-Prostate, #3651/AntiPS-MOA, #3643/Sorafenib-Liver, #4880/FH-Bavi-Imaging
3-24-11: Phil Thorpe, E.Ward, R.Ober, R.Mason awarded $6.0mm by Texas CPRIT http://tinyurl.com/4c2sm4k & http://tinyurl.com/65fjmpw
…"to develop a new class of [Anti-PS] therapeutics to treat cancers involving the brain & nervous systems, breast, liver, interhepatic bile duct, lung, bronchs, and prostate."
...…8-2011: UTSW Article about 3-2011 $6.0mm CPRIT Award to Thorpe/etal for AntiPS dev. http://tinyurl.com/4339hwp
......11-2011: UT-Dallas Article about Dr. Raimund Ober's role in 3-2011 $6.0mm CPRIT Award for AntiPS dev. http://tinyurl.com/3prrkm3
12-1-10: Dr. Phil Thorpe co-author of J.Clin.Investigation article about "novel therapies" for APS thrombus issues http://tinyurl.com/24ddq8h
…APS (antiphospholipid syndrome) can cause life-threatening clotting disorders. One of the mabs tested was 2aG4 (mouse model of Bavi).
4-12-10: IST program (Investigator Sponsored Trials) launched: http://tinyurl.com/y3yh5h3 & PeregrineInc/IST's
AACR'10 #1919 4-19-10: PS-Targeting Mabs Can Reverse Tumor-Induced Immune Suppression http://tinyurl.com/y266azk
…Dr. Thorpe, "This study shows that the immunosuppressive effects of PS exposed on apoptotic tumor cells can be reversed by PS-targeting antibodies, specifically by reversing the suppression of DC maturation caused by the exposed PS. This finding is important since reactivation of the immune system after the primary tumor has been removed is a critical line of defense in fighting cancer recurrence. Additionally, we showed that PS-targeting antibodies have the ability to confer tumor-specific immunity, which could lead to the future development of new cancer vaccine regimens."
4-21-10, AACR'10, 3 Wed. Posters (#5337,5330,5232) http://tinyurl.com/y65nyfc
BAVITUXIMAB ANTI-CANCER NEWS - Archive 2004-2009: http://tinyurl.com/6pjqt27
============================================================
III. ANTI-VIRAL NEWS ARCHIVES (2010-2012)
A. THE 2008-2011 DTRA/TMT Gov't Contract for Anti-PS vs. Hemorrhagic Fevers http://tinyurl.com/5dxpup
DTRA: www.dtra.mil FPDS.gov: http://tinyurl.com/4jbmkcg
3-11-11: TMT/DTRA will not extend VHF Contract - expires 3-15-11 (total revs. rec'd=$24.2mm): http://tinyurl.com/4p4hqr5
…Steve King (3-11-11 CC): "While this news is certainly disappointing, we are grateful to the TMT & DTRA for the opportunity to work together to evaluate bavituximab in this unique potential indication. We received nearly $24mm in funding over the past 33 mos… In the studies we have conducted to date under this contract, our antibodies have demonstrated a significant increase in survival in advanced preclinical models of the highly lethal Ebola virus. However in these specific studies, we weren't able to achieve an adequate dose response correlation to support advancing the program to the next stage. In no way does this dampen our enthusiasm for bavituximab and the PS-targeting platform for infectious diseases, where we believe there is still significant unrealized potential."
11-16-11: Two AntiPS posters presented at DTRA's 2011 CBD S&T/Vegas http://tinyurl.com/7pc76qd
...1) Argentine Hemorrhagic Fever/UTexas. . .2) Bacteria Infections/DSTL Porton Down/UK & Thorpe/King/C.Empig/PPHM
11-16-10: PPHM Presents AntiPS/VHFs pre-clin. data at CBDS&T BioDef Conf./Orlando http://tinyurl.com/4ve6xcl
10-2009: U-Pitt report for DARPA on Biologics Demand references Bavi http://tinyurl.com/yaefb4j
11-18-09: PPHM Presents AntiPS/VHFs pre-clin. data at DTRA/TMT Conf. http://tinyurl.com/ycrrwub
7-3-08 BioWorld Today article on PPHM's DTRA Deal: http://tinyurl.com/5kr6xk
...FULL ARCHIVE OF 2008-2011 DTRA GOV'T CONTRACT: http://tinyurl.com/6pjqt27
B. THE DUKE/HAYNES/CAVD/GATES/CHAVI/NIAID HIV COLLABORATION:
Duke's B.Haynes CAVD-Reports outline Thorpe's Role in the CAVD-Gates HIV-Vaccine Initiative: http://tinyurl.com/5xwjk4
…"Philip Thorpe is determining the role of lipid binding of anti-HIV antibodies and anti-phosphatidylserine (PS) autoantibodies to protection from HIV infection."
3-2014: Keystone Conf./Alberta PS-Targeting/HIV Poster by PPHM’s Cyril Empig & Duke/Peregrine Co-Authors Haynes/Moody/etc http://tinyurl.com/m6kuqpr
…”We expanded the characterization of PGN632 in the current study; PGN631 & PGN633, “sister clones” of PGN632, are also able to inhibit HIV-1 in the PBMC assay.”
12-29-11: Duke patent app#20110318360 "Anti-Lipid Antibodies" describes using PGN632 to inhibit HIV infection http://tinyurl.com/84vluj7
Sept'10: LWW article by Barton Haynes ref's 4-2010 Duke/PPHM JEM antiPS article: http://tinyurl.com/2bsgv8m
......"HIV vaccines after STEP: Strategies for Eliciting HIV-1 Inhibitory Antibodies"
4-11-10: CHAVI Newsletter highlights PPHM-Duke JEM article http://tinyurl.com/35eelvw
..."The study is significant because it shows that components of the adaptive immune system can activate antiviral innate immunity. Investigators believe that a vaccine that elicits polyreactive anti-PS antibodies could potentially be used to engage both the innate and adaptive immune response against HIV."
4-5-10: DukeHealth announces the 1st Duke/PPHM HIV Collab. article in JEM: http://tinyurl.com/yzr2tax
...Duke's Bart Haynes: "While the findings still have to be tested clinically, they do suggest a new way the immune system might be manipulated to thwart HIV."
...The full 4-5-10 JEM Duke-PPHM HIV article (23pgs) posted to PPHM's homepage: http://tinyurl.com/ydqdk59
2005-July2009: All Peregrine Public Statements on the Duke HIV Collab: http://tinyurl.com/m4aggy
10-14-08: "The AIDS Vaccine 2008 Conference", CapeTown, So.Africa http://tinyurl.com/7dnmpe
...Duke's B.Haynes & T.Moody present Anti-PS data for 1st time publicly: "The most potent mAb, PGN632 [11.31], inhibited 7/7 B & C clade HIV-1 isolates & SHIV SP162P3... Studies showed the mAbs acted at host cell surfaces to inhibit HIV-1 infection."
...Dr. Ralph Pantophlet's summary of T.Moody's Talk, incl. two PGN632=11.31 test data graphs: http://tinyurl.com/7w4udz
.....1-6-09: NIAID reviews CapeTown AIDS'08, commenting on the Tony Moody Anti-Lipids/PGN632 talk: http://tinyurl.com/7dnmpe
...FULL ARCHIVE OF DUKE-PPHM-CHAVI-CAVD HIV COLLABORATION: http://tinyurl.com/6pjqt27
C. OTHER ANTI-PS ANTI-VIRAL NEWS:
10-15-14: Public-Health-England/PPHM article on Bavi/Ebola in Hindawi’s Jrnl-of-Immunology-Res http://tinyurl.com/mg3va35 (also see: http://tinyurl.com/ofa5zlt )
6-2013: NIAID is “particularly interested how PS & PE expression… which is key to regulation of the immune response.” http://tinyurl.com/mvzqn26
…the above from John Coligan’s (PhD, Chief, Receptor Cell Biology Section) NIAID lab webpage.
11-16-12: 'Antiviral-Research' article by Bavi-AV collaborator HPA/UK & PPHM researchers on Bavi vs. EBOLA http://tinyurl.com/aa98xl3
…"Virus induced externalization of PS raises the possibility that PGN401 (Bavi) has broad spectrum antiviral activity."
11-16-12: 'Parasite Immunology' article by Dr. Phillip Thorpe & Brazilian Bavi-AV collaborators on AntiPS vs. Leishmania http://tinyurl.com/a8xtmny
..." This study provides new information regarding the mechanism of immune suppression in Leishmania infection."
8-2011: Brazilian collab's (INCA) studying PS-targeting vs. Leishmaniais, a protozoan parasitic disease http://tinyurl.com/435j8u2
11-4-09: 2nd Patent (7,611,704) Granted for AntiPS Broad AV apps http://tinyurl.com/y9jmsod
..."noteworthy since it includes methods for treating all viruses in humans & animals."
10-7-09: PPHM forms 'Anti-Viral Research Group' http://tinyurl.com/yan3fws
…"Peregrine's broad-spectrum PS-targeting antibodies are being assessed in anti-infective applications by more than a dozen leading research institutions… Peregrine and its collaborators have already secured over $60 million in research funding to evaluate the potential of the company's PS-targeting platform in a wide range of viral infections…"
9-10-09: PPHM's 7 Anti-PS Collaborators (S.King, R&R Healthcare Conf/NYC) http://tinyurl.com/nn4w8t
8-26-09: $763k NIAID Grant to Dr. Thorpe to Expand Anti-PS/VHF Studies: http://tinyurl.com/lxtuo3
…"The objective of the newly funded research is to evaluate a panel of new fully human anti-PS antibodies with different binding & functional properties as potential 2nd-gen. treatments."
8-5-09: 'New Scientist' Article Highlights Peregrine/Thorpe/BaviAV http://tinyurl.com/mp2aku
...Dr. Thorpe, "We were doing something that was quite extraordinary. We had let the animals progress in their disease until they were heavily symptomatic, and then started treatment. It was a major accomplishment to knock that disease back."
...7-11-09 Dr. Thorpe Interview on Bavi-AV in BMED Report: http://tinyurl.com/ltudso
3-31-09: 3rd (Conjugated) Anti-PE Patent (#7,511,124) Granted: http://tinyurl.com/dmkw6y
1-6-09: New 'Anti-PS Anti-viral Factsheet' on the PPHM Website: http://tinyurl.com/759qyw
11-24-08: Dr.Thorpe publishes in Dec.2008 NATURE Medicine on BaviAV vs. Lassa/CMV: http://tinyurl.com/9ktvsb
...Dr. Thorpe, "This is a whole new strategy for making antiviral drugs." . . . CEO S.King, "We think it has tremendous potential."
...Dr. B.Haynes, "Targeting a host cell lipid such as PS as an anti-viral strategy is an intriguing concept that may have relevance for new therapeutic and possibly prophylactic innovations in a number of virus infections."
...ARCHIVE OF OTHER ANTI-PS ANTI-VIRAL NEWS (2005 - 2008): http://tinyurl.com/6pjqt27
Thorpe's Aug03-Jan08 $1.68mm NIH/NIAID Grant for research using PPHM's APTs (Anti-PS/3G4) as "Novel Anti-Viral Agents for Treating Lassa Fever":
Thorpe: "We are developing drugs to use against Lassa fever that operate on a new principle in virology. They exploit the fact that viruses coat themselves with an outer membrane where some of the lipids are inside-out. The drugs direct our immune responses to the inside-out components of the viral membrane, or envelope. These drugs potentially could be effective against numerous viruses that have similar outer membranes… We have raised mabs to PS and other anionic phospholipids that block the spread of several viruses to uninfected cells in vitro, essentially completely. The phospholipids that they recognize have the same structure & cellular distribution in different mammalian species, simplifying the transition from experimental animals into humans. The antibodies are not toxic to mice, even when administered in high doses for prolonged periods of time."
GRANT LINK: http://tinyurl.com/5ntcm . . .11-3-03 Grant PR: http://tinyurl.com/5aulds
###8-26-09: $763k 2yr expansion NIAID grant (8/14/09-7/31/11) to Dr. Thorpe for 2nd-gen. anti-PS/VHF studies: http://tinyurl.com/lxtuo3
Large-Shareholders(36%) and RONIN-PPHM HISTORY, upd/10-30-17: Ronin’s 30-pg. PDF presentation, “Shareholders Seeking Change” (PDF: http://tinyurl.com/yawap9k5 ) - see below.
NOTE:
See below for PPHM-RONIN History of PR’s, Letters, 13-D’s, Form4’s, and Proxy’s (sorted: newest=>oldest).
KNOWN UPCOMING:
~Oct12(??based on 2016): Peregrine's Annual Shareholder’s Meeting (2016 attendee reports: http://tinyurl.com/jx7ouay )
Nov8-12: 32th Annual SITC’17, Natl-Harbor MD http://tinyurl.com/ybfm75wj
...1. PPHM-PrecisionMed: “Results of Epigenetic-Based Quantitative PCR Assisted Immune Cell Counting Analysis in Bavi SUNRISE Trial Subgroup”
...2. MSKCC-PPHM: “PS-Targeting In Combo w/Rad+Immune Checkpoint Blockade Promotes Anti-Tumor Activity in Mouse B16 Melanoma”
Dec11-15/Avid Booth #311: KNect365’s Antibody Eng. & Therapeutics Conf., SanDiego https://lifesciences.knect365.com/antibody-engineering-therapeutics
~Dec11: FY'18Q2 (qe 10-31-17) Financials & Conf. Call - http://ir.peregrineinc.com/events.cfm
Jan18-22 2018: Phacilitate’s Immunotherapy World Forum, Miami http://www.immunotherapyforum.com
...Jan18 12:30-12:45, Joe Shan(VP/Reg+Clin): “Turning up the Heat: PS-Targeting Antibodies Modulate the Tumor Microenvironment & Enhance Checkpoint Blockade”
= = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
10-27-17: Large Ownership Summary(35.7%) - now 16,113,738shs., 35.7% of 45,096,081 O/S at 9-6-17.
(Ronin+SW/Stafford+Farley+White, Eastern Cap./K.Dart, Institutions incl. Tappan’s 8-14-17/13G)
#1: 10-27-17/PR: Group Ronin Trading/SWInvest (John Stafford III+R.Farley+Stephen White) now has 9.6% stake (4,325,889sh.) in PPHM
...4,173,391 COMMON – 9.3% of 45,096,081 common O/S at 9-6-17 (total beneficial=4,325,889 if Pref. conv. x1.1905 to Common)
...128,099 PREFERRED – 7.8% of 1,647,760 preferred O/S at 7-31-17
NOTE: ALL historical common #’s adjusted for the 1:7 R/S eff. 7-10-17.
#2: 10-30-15: Kenneth Dart (Eastern Capital) acquires 9.5% stake (4,300,992sh.) in PPHM http://tinyurl.com/y95yskck
...3,777,183 COMMON – 8.4% of 45,096,081 common O/S at 9-6-17 (total beneficial=4,300,992 if Pref. conv. x1.1905 to Common, 9.5%)
...440,000 PREFERRED – 26.7% of 1,647,760 preferred O/S at 7-31-17
…...9-29-17/Form4: http://tinyurl.com/y9oadloa <=No chg. In Ownership; status update?
RONIN/SW 13D SUMMARY:
13D TransDates COMMON-CHG PREF-CHG ENDING-COMMON ENDING-PREF.
3-2-17 1/20/17-3/1/17 +2,947,425 +51,364 2,947,425 51,364 http://tinyurl.com/jr42u23
3-10-17 3/2/17-3/9/17 +433,509 +25,661 3,380,934 77,025 http://tinyurl.com/ydxra96u
4-17-17 3/28/17-4/10/17 0 +23,334 3,380,934 100,359 http://tinyurl.com/lanjddc
5-19-17 5/1/17-5/17/17 0 +23,140 3,380,934 123,499 http://tinyurl.com/mgnn92x
6-20-17 3/10/17-6/16/17 +378,170 0 3,759,105 123,499 http://tinyurl.com/y76q5rqu
6-29-17 6/21/17 +7,143 0 3,766,248 123,499 http://tinyurl.com/y9sp8bfv
7-14-17 6/29/17-7/7/17 +34,891 +3,600 3,801,139 127,099 http://tinyurl.com/ybra4s69
8-29-17 8/4/17-8/15/17 +27,252 0 3,828,391 127,099 http://tinyurl.com/yay55u3p (14A)
10-10-17 8/16/17-10/10/17 +45,000 0 3,873,391 127,099 http://tinyurl.com/ybvkjd3e (14A)
10-17-17 10/13/17-10/16/17 +109,573 +1,000 3,982,964 128,099 http://tinyurl.com/y983myco
10-27-17 10/17/17-10/27/17 +190,427 0 4,173,391 128,099 http://tinyurl.com/y7hslequ (14A)
SPLITOUT 13D GROUP into Ronin(John Stafford III, R.Farley) & SW-Partners(Stephen White):
Ronin Trading (Stafford) 3,173,391 115,299 (beneficial=3,310,652)
Ronin’s Roger Farley 300,000 1,000 (beneficial=301,190)
SW-Partners (White) 700,000 11,800 (beneficial=714,047)
- - - - - - - - - - - - - - -
Plus, INSTITUTIONS a/o 6-30-17: 7,476,857sh. = 16.6% <=incl. Tappan’s 8-14-17/13G,
...and KennedyCAP corrected 9,758,459=>1,394,066(Nasdaq R/S error)
...15,198,818 +(1,394,066-9,758,459) + (2,298,684-1,656,252) = 7,476,857
http://www.nasdaq.com/symbol/pphm/institutional-holdings
TOP7:
Tappan St. Partners 2,298,684 +1,384,380 <=per 8-14-17/13G(see below**)
Kennedy Capital Mgt. 1,394,066 +146,842
Vanguard Group 1,029,755 +146,791
Blackrock (Larry Fink) 806,022 -49,433
Renaissance Technologies 481,160 +41,487
Geode Capital Mgt. 225,679 +20,319
Bandera Partners 203,004 New
**8-14-17/13G: Tappan Street (Prasad Phatak) http://tinyurl.com/ybgqp9uq
2 Funds + P.Phatak’s personal shares:
...Partners LLC, Tappan St. Fund L.P. 1,540,000
...Tappan St. Partners Ideas Fund L.P. 691,577
...Prasad Phatak (Principle Owner) 67,107 Total TAPPAN: 2,298,684 (5.1%)
Note: Tappan Inst. Holdings a/o 3-31-17 was: 914,304, 1,656,252 at 6-30-17.
Large-Shareholders(36%) and RONIN-PPHM HISTORY, updated 10-27-17 for 2 reasons:
1. RONIN’s PR announcing Richard B. Hancock & Joel McComb as their 5th & 6th BOD nominees & calling again on Peregrine to hold the 2017 ASM w/o further delay. Also showing that Ronin’s Richard Farley has pur. +190,427sh. Common (open mkt) since the 10-17-17 13D, bringing his total Common to 300,000, and raising the Ronin/SW group beneficial to 4,325,889shs. (9.6% stake) as of 10-27-17 – passing E.CAPITAL(Dart). as PPHM’s #1 shareholder.
2. PPHM’s 10-27-17 Form4 for PPHM’s Mark Bamborth(new BOM#6) buying 50,000sh. Common @$4.50 (open mkt).
NOTE:
See below for PPHM-RONIN History of PR’s, Letters, 13-D’s, Form4’s, and Proxy’s (sorted: newest=>oldest).
KNOWN UPCOMING:
~Oct12(??based on 2016): Peregrine's Annual Shareholder’s Meeting (2016 attendee reports: http://tinyurl.com/jx7ouay )
Nov8-12: 32th Annual SITC’17, Natl-Harbor MD http://tinyurl.com/ybfm75wj
...1. PPHM-PrecisionMed: “Results of Epigenetic-Based Quantitative PCR Assisted Immune Cell Counting Analysis in Bavi SUNRISE Trial Subgroup”
...2. MSKCC-PPHM: “PS-Targeting In Combo w/Rad+Immune Checkpoint Blockade Promotes Anti-Tumor Activity in Mouse B16 Melanoma”
Dec11-15/Avid Booth #311: KNect365’s Antibody Eng. & Therapeutics Conf., SanDiego https://lifesciences.knect365.com/antibody-engineering-therapeutics
~Dec11: FY'18Q2 (qe 10-31-17) Financials & Conf. Call - http://ir.peregrineinc.com/events.cfm
Jan18-22 2018: Phacilitate’s Immunotherapy World Forum, Miami http://www.immunotherapyforum.com
...Jan18 12:30-12:45, Joe Shan(VP/Reg+Clin): “Turning up the Heat: PS-Targeting Antibodies Modulate the Tumor Microenvironment & Enhance Checkpoint Blockade”
= = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
10-27-17: Large Ownership Summary(35.7%) - now 16,113,738shs., 35.7% of 45,096,081 O/S at 9-6-17.
(Ronin+SW/Stafford+Farley+White, Eastern Cap./K.Dart, Institutions incl. Tappan’s 8-14-17/13G)
#1: 10-27-17/PR: Group Ronin Trading/SWInvest (John Stafford III+R.Farley+Stephen White) now has 9.6% stake (4,325,889sh.) in PPHM
...4,173,391 COMMON – 9.3% of 45,096,081 common O/S at 9-6-17 (total beneficial=4,325,889 if Pref. conv. x1.1905 to Common)
...128,099 PREFERRED – 7.8% of 1,647,760 preferred O/S at 7-31-17
NOTE: ALL historical common #’s adjusted for the 1:7 R/S eff. 7-10-17.
#2: 10-30-15: Kenneth Dart (Eastern Capital) acquires 9.5% stake (4,300,992sh.) in PPHM http://tinyurl.com/y95yskck
...3,777,183 COMMON – 8.4% of 45,096,081 common O/S at 9-6-17 (total beneficial=4,300,992 if Pref. conv. x1.1905 to Common, 9.5%)
...440,000 PREFERRED – 26.7% of 1,647,760 preferred O/S at 7-31-17
…...9-29-17/Form4: http://tinyurl.com/y9oadloa <=No chg. In Ownership; status update?
RONIN/SW 13D SUMMARY:
13D TransDates COMMON-CHG PREF-CHG ENDING-COMMON ENDING-PREF.
3-2-17 1/20/17-3/1/17 +2,947,425 +51,364 2,947,425 51,364 http://tinyurl.com/jr42u23
3-10-17 3/2/17-3/9/17 +433,509 +25,661 3,380,934 77,025 http://tinyurl.com/ydxra96u
4-17-17 3/28/17-4/10/17 0 +23,334 3,380,934 100,359 http://tinyurl.com/lanjddc
5-19-17 5/1/17-5/17/17 0 +23,140 3,380,934 123,499 http://tinyurl.com/mgnn92x
6-20-17 3/10/17-6/16/17 +378,170 0 3,759,105 123,499 http://tinyurl.com/y76q5rqu
6-29-17 6/21/17 +7,143 0 3,766,248 123,499 http://tinyurl.com/y9sp8bfv
7-14-17 6/29/17-7/7/17 +34,891 +3,600 3,801,139 127,099 http://tinyurl.com/ybra4s69
8-29-17 8/4/17-8/15/17 +27,252 0 3,828,391 127,099 http://tinyurl.com/yay55u3p (14A)
10-10-17 8/16/17-10/10/17 +45,000 0 3,873,391 127,099 http://tinyurl.com/ybvkjd3e (14A)
10-17-17 10/13/17-10/16/17 +109,573 +1,000 3,982,964 128,099 http://tinyurl.com/y983myco
10-27-17 10/17/17-10/27/17 +190,427 0 4,173,391 128,099 http://tinyurl.com/y7hslequ (14A)
SPLITOUT 13D GROUP into Ronin(John Stafford III, R.Farley) & SW-Partners(Stephen White):
Ronin Trading (Stafford) 3,173,391 115,299 (beneficial=3,310,652)
Ronin’s Roger Farley 300,000 1,000 (beneficial=301,190)
SW-Partners (White) 700,000 11,800 (beneficial=714,047)
- - - - - - - - - - - - - - -
Plus, INSTITUTIONS a/o 6-30-17: 7,476,857sh. = 16.6% <=incl. Tappan’s 8-14-17/13G,
...and KennedyCAP corrected 9,758,459=>1,394,066(Nasdaq R/S error)
...15,198,818 +(1,394,066-9,758,459) + (2,298,684-1,656,252) = 7,476,857
http://www.nasdaq.com/symbol/pphm/institutional-holdings
TOP7:
Tappan St. Partners 2,298,684 +1,384,380 <=per 8-14-17/13G(see below**)
Kennedy Capital Mgt. 1,394,066 +146,842
Vanguard Group 1,029,755 +146,791
Blackrock (Larry Fink) 806,022 -49,433
Renaissance Technologies 481,160 +41,487
Geode Capital Mgt. 225,679 +20,319
Bandera Partners 203,004 New
**8-14-17/13G: Tappan Street (Prasad Phatak) http://tinyurl.com/ybgqp9uq
2 Funds + P.Phatak’s personal shares:
...Partners LLC, Tappan St. Fund L.P. 1,540,000
...Tappan St. Partners Ideas Fund L.P. 691,577
...Prasad Phatak (Principle Owner) 67,107 Total TAPPAN: 2,298,684 (5.1%)
Note: Tappan Inst. Holdings a/o 3-31-17 was: 914,304, 1,656,252 at 6-30-17.
10-27-17/Form4: PPHM’s New BOD/Member(#6) Mark Bamforth Buys 50,000sh. Common. I do believe these are straight open market purchases, at an avg. price of ~$4.50. Ie, NOT related to his 10-17-17 Form4 for 75,000sh. Options @$3.88 which will Vest monthly over 36mos., the first beg. 11-17-17.
Let me know if I’m reading this Form4 wrong.
10-27-17/Form4: PPHM’s New BOD Member (#6) Mark Bamborth Pur. 50,000sh. Common at ~4.50/sh. http://tinyurl.com/ya7pyyu5
- - - -
Recall this 10-17-17 OPTIONS Form4 for M/Bamforth (http://tinyurl.com/ybfm5tfe ):
...Mark R. Bamforth 75,000sh. @$3.88 (BOD #6) - vesting monthly over 36mos, beg. 11-17-17
= = = = = =
10-19-17: Peregrine Adds Mark R. Bamforth to BOD http://tinyurl.com/ydxlv7sb
10-23-17/8-K M.R. Bamforth Hiring Details: http://tinyurl.com/y7mvg6wt
=> SUMMARY: $55000/yr + $15000/committee + $2000/meeting; “The Compensation Committee expects that existing non-emp. directors will transition to the new non-emp. director compensation pgm over a period of time.”…
James, if grapevine true, it has to be M.Bamforth(BOD#6) or P.Walsh(BOD#7), and can’t happen until 11-17-17 or 11-20-17, their 1st month’s vesting, respectively (monthly equal installs over 36mos). Can’t be Avid CEO R.Lias(BOD#5), because his 1st year’s vesting (equal yearly installs over 4yrs) doesn’t happen until 9-25-2018.
(If I’m reading the Form4’s right)
Sept'17 & Oct'17 PPHM/Form4’s for New BOD’s Lias/Bamforth/Walsh (Options Awarded):
...Patrick D. Walsh 75,000sh. @$4.08 http://tinyurl.com/y7yrcwez (BOD #7) - vesting monthly over 36mos, beg. 11-20-17
...Mark R. Bamforth 75,000sh. @$3.88 http://tinyurl.com/ybfm5tfe (BOD #6) - vesting monthly over 36mos, beg. 11-17-17
...Roger J. Lias 150,000sh. @$3.19 http://tinyurl.com/yavfa6w7 (CEO/Avid, BOD #5) - vesting in 4 equal annual installments beg. 9-25-18
= = = = = = = = = = = = = = = = =
10-24-17: http://tinyurl.com/yd3mtowk
Large-Shareholders(35%), RONIN-PPHM HISTORY, Upcoming Events: updated 10-24-17 w/PPHM’s PR announcing that Patrick Walsh is joining the BOD of both Peregrine & Avid (7th member), “An Industry Veteran with 30+yrs Experience Leading Successful CDMO Organizations”.
10-23-17/8-K: “Recently Amended” BOD Compensation Program http://tinyurl.com/y7mvg6wt
$55000/yr + $15000/committee + $2000/meeting; “The Compensation Committee expects that existing non-emp. directors will transition to the new (“recently amended”) non-emp. director compensation pgm over a period of time.”
Last 3 PPHM/Form4’s for Lias/Bamforth/Walsh
10-24-17 FORM4’S FOR OPTIONS GRANTED:
...(both vesting monthly over 36mos. Beg. 11-20-17)
1. Mark R. Bamforth 75,000sh. @$3.88 http://tinyurl.com/ybfm5tfe (BOD #6)
2. Patrick D. Walsh 75,000sh. @$4.08 http://tinyurl.com/y9hf7d8a (BOD #7)
9-27-17 FORM4 FOR OPTIONS GRANTED:
...(vesting in 4 equal annual installments beg. 9-25-18)
Roger J. Lias 150,000sh. @$3.19 http://tinyurl.com/yavfa6w7 (CEO/Avid, BOD #5)
= = = = = = = = = = = = = = = = =
10-24-17: http://tinyurl.com/yd3mtowk
Large-Shareholders(35%), RONIN-PPHM HISTORY, Upcoming Events: updated 10-24-17 w/PPHM’s PR announcing that Patrick Walsh is joining the BOD of both Peregrine & Avid (7th member), “An Industry Veteran with 30+yrs Experience Leading Successful CDMO Organizations”.
NOTE:
RONIN/SWIM’s 8-29-17 PRELIM. Proxy Statement (14A) and PPHM’s 8-28-17 Amended 10-K were added previously, as well as Ronin’s 10-10-17 PR announcing they will nominate James J. Egan as their 4th BOD candidate, Ronin’s Roger Farley establishing a stake of 110,763sh. Oct13-16, and PPHM’s 10-19-17 stating that, “Peregrine is transitioning from an R&D focused business to a pure play CDMO”, and “is pursuing to license or sell its proprietary R&D assets, including its lead immunotherapy candidate, bavituximab...”, and PPHM’s 10-23-17 giving the compensation details for new BOD member Mark R. Bamforth: $55000/yr + $15000/committee + $2000/meeting – plus, “The Compensation Committee expects that existing non-emp. directors will transition to the new (“recently amended”) non-emp. director compensation pgm over a period of time.”
. . .
Large-Shareholders(35%), RONIN-PPHM HISTORY, Upcoming Events: updated 10-24-17 w/PPHM’s PR announcing that Patrick Walsh is joining the BOD of both Peregrine & Avid (7th member), “An Industry Veteran with 30+yrs Experience Leading Successful CDMO Organizations”.
NOTE:
RONIN/SWIM’s 8-29-17 PRELIM. Proxy Statement (14A) and PPHM’s 8-28-17 Amended 10-K were added previously, as well as Ronin’s 10-10-17 PR announcing they will nominate James J. Egan as their 4th BOD candidate, Ronin’s Roger Farley establishing a stake of 110,763sh. Oct13-16, and PPHM’s 10-19-17 stating that, “Peregrine is transitioning from an R&D focused business to a pure play CDMO”, and “is pursuing to license or sell its proprietary R&D assets, including its lead immunotherapy candidate, bavituximab...”, and PPHM’s 10-23-17 giving the compensation details for new BOD member Mark R. Bamforth: $55000/yr + $15000/committee + $2000/meeting – plus, “The Compensation Committee expects that existing non-emp. directors will transition to the new (“recently amended”) non-emp. director compensation pgm over a period of time.” - see below...
KNOWN UPCOMING:
~Oct12(??based on 2016): Peregrine's Annual Shareholder’s Meeting (2016 attendee reports: http://tinyurl.com/jx7ouay )
Nov8-12: 32th Annual SITC’17, Natl-Harbor MD http://tinyurl.com/ybfm75wj
...1. PPHM-PrecisionMed: “Results of Epigenetic-Based Quantitative PCR Assisted Immune Cell Counting Analysis in Bavi SUNRISE Trial Subgroup”
...2. MSKCC-PPHM: “PS-Targeting In Combo w/Rad+Immune Checkpoint Blockade Promotes Anti-Tumor Activity in Mouse B16 Melanoma”
Dec11-15/Avid Booth #311: KNect365’s Antibody Eng. & Therapeutics Conf., SanDiego https://lifesciences.knect365.com/antibody-engineering-therapeutics
~Dec11: FY'18Q2 (qe 10-31-17) Financials & Conf. Call - http://ir.peregrineinc.com/events.cfm
Jan18-22 2018: Phacilitate’s Immunotherapy World Forum, Miami http://www.immunotherapyforum.com
...Jan18 12:30-12:45, Joe Shan(VP/Reg+Clin): “Turning up the Heat: PS-Targeting Antibodies Modulate the Tumor Microenvironment & Enhance Checkpoint Blockade”
= = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
10-17-17: Large Ownership Summary(35.3%), RONIN Letters/PPHM Comments
Large Ownership now ~15.9mm shares, 35.3% of 45,096,081 O/S at 9-6-17. (Ronin+SW/Stafford+Farley+White, Eastern Cap./K.Dart, Institutions incl. Tappan’s 8-14-17/13G)
#1: 10-30-15: Kenneth Dart (Eastern Capital) acquires 9.5% stake (4,300,992sh.) in PPHM http://tinyurl.com/y95yskck
...3,777,183 COMMON – 8.4% of 45,096,081 common O/S at 9-6-17 (total beneficial=4,300,992 if Pref. conv. x1.1905 to Common, 9.5%)
...440,000 PREFERRED – 26.7% of 1,647,760 preferred O/S at 7-31-17
…...9-29-17/Form4: http://tinyurl.com/y9oadloa <=No chg. In Ownership; status update?
#2: 10-17-17/13D: Group Ronin Trading/SWInvest (John Stafford III+R.Farley+Stephen White) now has 9.2% stake (4,135,462sh.) in PPHM
...3,982,964 COMMON – 8.8% of 45,096,081 common O/S at 9-6-17 (total beneficial=4,135,462 if Pref. conv. x1.1905 to Common)
...128,099 PREFERRED – 7.8% of 1,647,760 preferred O/S at 7-31-17
NOTE: ALL historical common #’s adjusted for the 1:7 R/S eff. 7-10-17.
RONIN/SW 13D SUMMARY:
13D TransDates COMMON-CHG PREF-CHG ENDING-COMMON ENDING-PREF.
3-2-17 1/20/17-3/1/17 +2,947,425 +51,364 2,947,425 51,364 http://tinyurl.com/jr42u23
3-10-17 3/2/17-3/9/17 +433,509 +25,661 3,380,934 77,025 http://tinyurl.com/ydxra96u
4-17-17 3/28/17-4/10/17 0 +23,334 3,380,934 100,359 http://tinyurl.com/lanjddc
5-19-17 5/1/17-5/17/17 0 +23,140 3,380,934 123,499 http://tinyurl.com/mgnn92x
6-20-17 3/10/17-6/16/17 +378,170 0 3,759,105 123,499 http://tinyurl.com/y76q5rqu
6-29-17 6/21/17 +7,143 0 3,766,248 123,499 http://tinyurl.com/y9sp8bfv
7-14-17 6/29/17-7/7/17 +34,891 +3,600 3,801,139 127,099 http://tinyurl.com/ybra4s69
8-29-17 8/4/17-8/15/17 +27,252 0 3,828,391 127,099 http://tinyurl.com/yay55u3p (14A)
10-10-17 8/16/17-10/10/17 +45,000 0 3,873,391 127,099 http://tinyurl.com/ybvkjd3e (14A)
10-17-17 10/13/17-10/16/17 +109,573 +1,000 3,982,964 128,099 http://tinyurl.com/y983myco
SPLITOUT 13D GROUP into Ronin(John Stafford III, R.Farley) & SW-Partners(Stephen White):
Ronin Trading (Stafford) 3,173,391 115,299 (beneficial=3,310,652)
Ronin’s Roger Farley 109,573 1,000 (beneficial=110,763)
SW-Partners (White) 700,000 11,800 (beneficial=714,047)
- - - - - - - - - - - - - - -
Plus, INSTITUTIONS a/o 6-30-17: 7,476,857sh. = 16.6% <=incl. Tappan’s 8-14-17/13G,
...and KennedyCAP corrected 9,758,459=>1,394,066(Nasdaq R/S error)
...15,198,818 +(1,394,066-9,758,459) + (2,298,684-1,656,252) = 7,476,857
http://www.nasdaq.com/symbol/pphm/institutional-holdings
TOP7:
Tappan St. Partners 2,298,684 +1,384,380 <=per 8-14-17/13G(see below**)
Kennedy Capital Mgt. 1,394,066 +146,842
Vanguard Group 1,029,755 +146,791
Blackrock (Larry Fink) 806,022 -49,433
Renaissance Technologies 481,160 +41,487
Geode Capital Mgt. 225,679 +20,319
Bandera Partners 203,004 New
**8-14-17/13G: Tappan Street (Prasad Phatak) http://tinyurl.com/ybgqp9uq
2 Funds + P.Phatak’s personal shares:
...Partners LLC, Tappan St. Fund L.P. 1,540,000
...Tappan St. Partners Ideas Fund L.P. 691,577
...Prasad Phatak (Principle Owner) 67,107 Total TAPPAN: 2,298,684 (5.1%)
Note: Tappan Inst. Holdings a/o 3-31-17 was: 914,304, 1,656,252 at 6-30-17.
10-23-17/8-K: New PPHM BOD Mark Bamforth’s Compensation Details: $55000/yr + $15000/committee + $2000/meeting; “The Compensation Committee expects that existing non-emp. directors will transition to the new non-emp. director compensation pgm over a period of time.”...
10-19-17: Peregrine Adds Mark R. Bamforth to BOD http://tinyurl.com/ydxlv7sb
10-23-17/8-K M.R. Bamforth Hiring Details: http://tinyurl.com/y7mvg6wt
...“On 10-17-17, the BOD adopted a resolution to incr. the #BOD’s from 5 to 6, Mr. Bamforth to join immediately… Mr. Bamforth… will receive compensation under the Company’s non-emp. Director compensation pgm, which was recently amended… He will rec. $55,000/yr. + $15,000/yr. for each committee served (at the time of the filing, the Board had not yet determined the committee(s) of the Board on which Mr. Bamforth would serve)… In addition, Mr. Bamforth is eligible to receive $2,000/day for each BOD meeting attended, whether in-person or telephonically, and is entitled to receive $2,000 for each addl. Company meeting attended in excess of 4hrs in length. The Compensation Committee expects that existing non-emp. directors will transition to the new non-emp. director compensation pgm over a period of time.”
- - - - - - - - -
10-19-17/PR: ...Mr. Bamforth has 30yrs of biologics leadership experience, including founding 2 CDMOs, Brammer Bio, where he is currently Pres./CEO, and Gallus BioPharmaceuticals, which was acquired by DPx Holdings B.V., the parent company of Patheon. Additionally, he served 20+yrs in key roles at Genzyme Corp., including 10yrs as a corp. officer responsible for running global mfg.
STEVE KING: "Mark is a great addition to the board of directors as we continue our transition to becoming a dedicated CDMO business. With his extensive experience in the CDMO space, both as an entrepreneur who has founded, grown, acquired and sold a successful CDMO company, as well as his experience as a key executive at Genzyme Corporation, he is ideally suited to help oversee the transition of the company into a leading CDMO. Combined with the recent appointment of Dr. Roger Lias as Pres. of Avid and member of Peregrine's BOD, today's appointment further underscores our commitment to reconstitute the BOD with high quality CDMO industry experience. We look forward to providing further updates in the near future as we continue the process."
Based in Cambridge MA, Mr. Bamforth currently serves as Pres./CEO of Brammer Bio, a cell & gene therapy CDMO he founded in 2015 and merged with Florida Biologix, an established, 10yo CDMO, in 3-2016. In this role, he oversees a team of 300+ emps, providing services ranging from process dev. and early clinical supply services to production of Ph3 supplies & support for licensure of gene therapy products. Previously, he founded Gallus BioPharmaceuticals, a biologics CDMO that experienced rapid growth leading to its acquisition by DPx Holdings B.V., the parent company of Patheon, in 2014 for $257.2M.
Prior to his founding of Brammer Bio & Gallus BioPharmaceuticals, Mr. Bamforth spent 22yrs with Genzyme Corp., rising to the position of SVP/Corp.Oper./Pharmaceuticals. In this role, he oversaw a multi-technology, global operations team comprised of 3,600+ at 13 internal sites & a network of 24 CMO’s. This team was charged with supplying 20+ commercial products and multiple clinical products that spanned biologics, cell therapy, gene therapy, pharmaceuticals and biologic devices. While at Genzyme, Mr. Bamforth served as a member of the CEO's operating committee, helping to guide corporate strategy acquisition, partnering and growth to over $4B in sales.
MARK BAMFORTH: "We continue to see significant growth potential in the CDMO space, particularly for companies that understand the nuanced needs of biopharmaceutical companies and can offer creative and sophisticated dev. & mfg. solutions. I believe that Avid Bioservices is well positioned to capitalize on these growth opportunities based on its state-of-the-art Myford mfg. facility, as well as its established track record of commercial & clinical mfg. & regulatory excellence. I am pleased to have the opportunity to join the boards of both Peregrine & Avid at this exciting time of transition for the companies and look forward to sharing my industry experience to contribute to the ongoing success of the CDMO business."
Mr. Bamforth also serves on the boards of MassBio and the Wentworth Inst. of Technology, and is a Saltire Foundation founding-trustee. He earned a BS in chemical eng. from Strathclyde Univ. and an MBA from Henley Mgt. College.
Avid Bioservices was established out of Peregrine's internal biologics mfg. & dev. capabilities and began formal operations in Jan.2002. The company has grown from an internal support operation to a full service CDMO that manufactures bulk drug substance for products that are approved & marketed in over 18 countries by leading biopharma companies. Avid was recently recognized as a leading CDMO by Life Science Leader as a recipient of multiple 2017 Contract Mfg. Leadership Awards for Quality, Reliability, Capabilities, Expertise and Compatibility. The company has an outstanding regulatory inspection history and state-of-the-art cGMP mfg. facilities. Mr. King has served as Pres. of Avid since its formation in addition to his role as Pres./CEO of Peregrine since 2003.
ABOUT PEREGRINE PHARMACEUTICALS, INC.
Peregrine Pharmaceuticals, Inc. is a company transitioning from an R&D focused business to a pure play contract dev. & mfg. organization (CDMO)… The company is pursuing to license or sell its proprietary R&D assets, including its lead immunotherapy candidate, bavituximab, which is currently being evaluated in clinical trials in combination with immune stimulating therapies for the treatment of various cancers...
IMPORTANT ADDL. INFO:
Peregrine intends to file a proxy statement with the SEC in connection with the solicitation of proxies for Peregrine's 2017 ASM (Proxy Statement) with an associated WHITE proxy card. Peregrine, its directors and certain of its exec. officers will be participants in the solicitation of proxies from stockholders in respect of the 2017 ASM. Info regarding the names of Peregrine's directors & exec. officers and their respective interests in Peregrine by security holdings or otherwise is set forth in the 10-K for FY/e 4-30-17 [7-14-17: http://tinyurl.com/ycxu4l5n ], and Peregrine's proxy statement for the 2016 ASM [8-26-16: http://tinyurl.com/gsrmgs2 ]. To the extent holdings of such participants in Peregrine's securities are not reported, or have changed since the amounts described, in the 2016 proxy statement, such changes have been reflected on [Form3’s & Form4’s]… Details concerning the nominees of Peregrine's BOD for election at the 2017 ASM will be included in the Proxy Statement…
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10-19-17: Large-Shareholders(35%), RONIN-PPHM HISTORY, Upcoming Events http://tinyurl.com/yccrte6b
Nice find re: 10-17-17 WCLC'17/IASLC SUNRISE presentation, Huts. DELETE.
10-17-17: Sunrise Subset Results presented at WCLC/IASLC’17/Japan. I believe this data was taken from the 9-9-17 ESMO’17 presentation of Final SUNRISE results (Madrid http://tinyurl.com/yb9kjutp ), which stated, “In an exploratory analysis of OS for pts who received subsequent immune checkpoint inhibitors (ICI), mOS was not reached.”...
Oct15-18 2017: “WCLC’17 - IASLC’s 18th World Conf. on Lung Cancer”, Yokohama, Japan
“Medical doctors, scientists, nurses, health professionals, government officials, partners from the industry, health advocacy groups and patients will come together in order to obtain and exchange information on advances in the management of lung cancer and other thoracic malignancies, while considering both global & regional aspects..”
http://wclc2017.iaslc.org
IASLC = Intl. Association for the Study of Lung Cancer - http://iaslc.org
WCLC = World Conference on Lung Cancer (IASLC)
Pgm: https://library.iaslc.org/conference-program?product_id=7
Track: Immunology & Immunotherapy
Presentation: Mini-Oral #MA 10
Moderators: S. Wang, Robert Pirker (http://tlcr.amegroups.com/user/view/750 )
10-17-17 11:30-11:35pm #MA 10.05 (Mini-Oral):
“Improved Outcome for Immune Checkpoint Inhibitors (ICI) in Patients Previously Treated with Bavituximab in the SUNRISE Trial”
Michael Boyer (presenting author*), David R Spigel, P. Mainwaring, H. Lena, M. McCleod, G. Losonczy, R.E. Sanborn, R. Natale, M. Tang, J. Lai, N.L. Kallinteris, Joseph Shan, David E Gerber (senior author, UTSW)
- - - - - - -
*MICHAEL BOYER (MBBS, PhD, IASLC’13 Conf. President): professor at the Sydney CC in Sydney, Australia. His research interests include new agents for the treatment of lung cancer. http://sydney.edu.au/medicine/people/academics/profiles/michael.boyer.php
ABSTRACT:
BACKGROUND: Bavituximab targets exposed phosphatidylserine (PS) in the tumor microenvironment, resulting in repolarization of myeloid suppressor cells/M2 macrophages to M1, production of pro-inflammatory cytokines such as IFN? and IL-12, dendritic cell maturation, and tumor specific cytotoxic T-cell activation. SUNRISE was a Phase III trial of docetaxel with bavituximab (D+B) or placebo (D+P) in patients with treated Stage IIIb/IV non-squamous NSCLC. Recent correlative analyses from SUNRISE suggest bavituximab is more active in PD-L1 negative, immune cold tumors and thus may complement PD-1/PD-L1 ICI.
METHODS: This subgroup analysis included all patients who received subsequent ICI after discontinuing SUNRISE study drug. We calculated overall survival (OS) both from randomization and start of subsequent ICI.
RESULTS: 93 of 597 randomized patients (16%) received ICI as next line of therapy after SUNRISE assigned treatment. Baseline characteristics were balanced between the treatment groups and consistent with the ITT population. From randomization, mOS was not reached (95% CI, 15.2-NA) in D+B (N=46) and 12.6mos. (95% CI, 10.4-17.8) in D+P (N=47) (HR, 0.46; P=0.006). From start of ICI, mOS was not reached (95% CI, 10.2-NA) in D+B and 6.2mos. (95% CI, 3.9-8.7) in D+P (HR, 0.42; P=0.002). The mPFS was 6.0mos. (95% CI, 3.5-6.5) in D+B and 4.4mos. (95% CI, 2.6-6.3) in D+P (HR, 1.00; P=0.991). ORR was 20% vs. 13% (Odds ratio 0.6; P=0.41) for D+B and D+P, respectively. The safety profile was similar between groups and no immune related (IR) toxicities (colitis, pneumonitis, hypothyroidism) were reported.
CONCLUSIONS: Within the limits of a subgroup analysis, a significant improvement in OS was observed for patients previously treated with D+B. Furthermore, bavituximab has not been associated with IR toxicities and might serve as a useful drug in combination with ICI for the treatment of immune cold tumors.
Fig.1:
= = = = = = = = = = = = =
BAVITUXIMAB "SUNRISE" PHASE III TRIAL: http://www.SunriseTrial.com (Start=Dec'13 EstPrimComp=Dec’16)
A. Phase III Bavi+Doce vs. 2nd-Line NSCLC "SUNRISE" (randomized, double-blind, placebo-ctl'd, n=582)
USA Protocol: http://www.clinicaltrials.gov/ct2/show/NCT01999673 <=chgd. to "Active, Not Recruiting." 2-1-16
...2 ARMS: A=BAVI/3mg+DOCE(Weekly), B=Doce+Placebo(Weekly)
...ECOG's: Ph3SUNRISE/0-1, Ph2Bavi+Doce(n=120)/0-1-2, Ph2Bavi+Durva(AZN)/0-1, Ph3Herbst2010/0-1 (2L/NSCLC)
...161 sites a/o 7-9-15 (USA/39 Aus/9 Bel/7 Fr/9 Ger/15 Greece/10 Hungary/7 Italy/10 Korea/9 Rom/6 Rus/8 Spain/16 Taiwan/10 Ukraine/6) - Growth: http://tinyurl.com/qbemrr2
...Sunrise Biomarker studies - 4 announced thru ASCO'17, see http://tinyurl.com/ydhf6tfx
......#1 10-10-16/ESMO’16: B2GPI/200-240(30%pts) StatSig MOS 7.7=>13.2mos. http://tinyurl.com/hp73njt
......#2 12-7-16/WCLC’16(IASLC): “Complement & IL-10 Pathways: Pts Benefiting from Bavi+Doce” <=Presentation CANCELLED/”Anal.Not.Finished(IR)” http://tinyurl.com/z8cq8vx
......#3 4-3-17/AACR'17: "IFN-y Analysis In Blood & Tissue as a Potential Prognostic and/or Predictive Biomarker” See: http://tinyurl.com/ktzr782
......#4 6-3-17/ASCO'17: "Prelim. Correlative Analysis of PD-L1 Expression from the Sunrise Study” See ASCO'17: http://tinyurl.com/y93upatl
9-9-17/ESMO’17(Madrid): Final SUNRISE Ph3 Data to be presented (poster# 1364P) http://tinyurl.com/yb9kjutp
..."In an exploratory analysis of OS for pts who received subsequent immune checkpoint inhibitors (ICI), mOS was not reached.”
2-25-16: IDMC Halts SUNRISE at 1st Look-in. Bavi+Doce arm “OS performing as expected”; Doce arm “dramatically outperforming OS expectations” http://tinyurl.com/jbg48vs
...CC Replay: http://edge.media-server.com/m/p/xfa9fy5v 12:22/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.”
2-1-16: SUNRISE Trial status updated: “Study ongoing, but not recruiting.” http://www.clinicaltrials.gov/ct2/show/NCT01999673
12-10-15: “Sunrise >90% enrolled; sufficient to allow the 2 planned interim looks (33%/50%) & final readout based on PrimEndPt=OS” http://tinyurl.com/jkp885g
5-31-14 ASCO’14: David Gerber/Joe Shan Poster on Ph3/SUNRISE Trial (#TPS8129) http://tinyurl.com/nv4jloo
3-7-14: PR & Conf-Call: "first patients enrolled and dosed." http://tinyurl.com/kh9cnrg
1-6-14: FDA grants FAST TRACK status to Bavi in 2ndLine NSCLC http://tinyurl.com/l799ukk
12-30-13: Pivotal Ph.3 ‘SUNRISE’ NSCLC Trial Initiated (n=~600, sites=100+) http://tinyurl.com/kdjb9qz
5-20-13: FDA Approves Bavituximab Ph.III Design for 2L/NSCLC; 600-pt trial to begin by y/e’13 http://tinyurl.com/n3dxtm6
...S.King: “We will now focus on starting the Ph.III trial while continuing ongoing partnering discussions.”
…R.Garnick: “This was a highly collaborative effort with the FDA; this trial, when combined with Bavi’s supporting data to date, could be sufficient to support a future BLA submission."
JDM, M.Bamforth's MassBio/profile says he lives in CambridgeMA, not England:
"Mark Bamforth is currently establishing a cell & gene therapy CMO, Brammer Biopharmaceuticals... He lives in Cambridge, MA with his wife and two children...
...Bamforth has 22 years of previous experience in the UK and USA running a diverse, global mfg. operation and a pharmaceutical CMO business for Genzyme Corp..."
https://www.massbio.org/about/board-of-directors/mark-r-bamforth-43521
Large-Shareholders(35%), RONIN-PPHM HISTORY, Upcoming Events: updated 10-19-17 with PPHM’s PR announcing that Mark R. Bamforth has joined its BOD. The PR also states, “Peregrine is transitioning from an R&D focused business to a pure play contract dev. & mfg. organization (CDMO)”, and “Peregrine is pursuing to license or sell its proprietary R&D assets, including its lead immunotherapy candidate, bavituximab...”.
NOTE:
RONIN/SWIM’s 8-29-17 PRELIM. Proxy Statement (14A) and PPHM’s 8-28-17 Amended 10-K were added previously, as well as Ronin’s 10-10-17 PR announcing they will nominate James J. Egan as their 4th BOD candidate, and Ronin’s Roger Farley establishing a stake of 110,763sh. Oct13-16 – see below...
KNOWN UPCOMING:
~Oct12(??based on 2016): Peregrine's Annual Shareholder’s Meeting (2016 attendee reports: http://tinyurl.com/jx7ouay )
Nov8-12: 32th Annual SITC’17, Natl-Harbor MD http://tinyurl.com/ybfm75wj
...1. PPHM-PrecisionMed: “Results of Epigenetic-Based Quantitative PCR Assisted Immune Cell Counting Analysis in Bavi SUNRISE Trial Subgroup”
...2. MSKCC-PPHM: “PS-Targeting In Combo w/Rad+Immune Checkpoint Blockade Promotes Anti-Tumor Activity in Mouse B16 Melanoma”
Dec11-15/Avid Booth #311: KNect365’s Antibody Eng. & Therapeutics Conf., SanDiego https://lifesciences.knect365.com/antibody-engineering-therapeutics
~Dec11: FY'18Q2 (qe 10-31-17) Financials & Conf. Call - http://ir.peregrineinc.com/events.cfm
Jan18-22 2018: Phacilitate’s Immunotherapy World Forum, Miami http://www.immunotherapyforum.com
...Jan18 12:30-12:45, Joe Shan(VP/Reg+Clin): “Turning up the Heat: PS-Targeting Antibodies Modulate the Tumor Microenvironment & Enhance Checkpoint Blockade”
= = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
10-17-17: Large Ownership Summary(35.3%), RONIN Letters/PPHM Comments
Large Ownership now ~15.9mm shares, 35.3% of 45,096,081 O/S at 9-6-17. (Ronin+SW/Stafford+Farley+White, Eastern Cap./K.Dart, Institutions incl. Tappan’s 8-14-17/13G)
#1: 10-30-15: Kenneth Dart (Eastern Capital) acquires 9.5% stake (4,300,992sh.) in PPHM http://tinyurl.com/y95yskck
...3,777,183 COMMON – 8.4% of 45,096,081 common O/S at 9-6-17 (total beneficial=4,300,992 if Pref. conv. x1.1905 to Common, 9.5%)
...440,000 PREFERRED – 26.7% of 1,647,760 preferred O/S at 7-31-17
…...9-29-17/Form4: http://tinyurl.com/y9oadloa <=No chg. In Ownership; status update?
#2: 10-17-17/13D: Group Ronin Trading/SWInvest (John Stafford III+R.Farley+Stephen White) now has 9.2% stake (4,135,462sh.) in PPHM
...3,982,964 COMMON – 8.8% of 45,096,081 common O/S at 9-6-17 (total beneficial=4,135,462 if Pref. conv. x1.1905 to Common)
...128,099 PREFERRED – 7.8% of 1,647,760 preferred O/S at 7-31-17
NOTE: ALL historical common #’s adjusted for the 1:7 R/S eff. 7-10-17.
RONIN/SW 13D SUMMARY:
13D TransDates COMMON-CHG PREF-CHG ENDING-COMMON ENDING-PREF.
3-2-17 1/20/17-3/1/17 +2,947,425 +51,364 2,947,425 51,364 http://tinyurl.com/jr42u23
3-10-17 3/2/17-3/9/17 +433,509 +25,661 3,380,934 77,025 http://tinyurl.com/ydxra96u
4-17-17 3/28/17-4/10/17 0 +23,334 3,380,934 100,359 http://tinyurl.com/lanjddc
5-19-17 5/1/17-5/17/17 0 +23,140 3,380,934 123,499 http://tinyurl.com/mgnn92x
6-20-17 3/10/17-6/16/17 +378,170 0 3,759,105 123,499 http://tinyurl.com/y76q5rqu
6-29-17 6/21/17 +7,143 0 3,766,248 123,499 http://tinyurl.com/y9sp8bfv
7-14-17 6/29/17-7/7/17 +34,891 +3,600 3,801,139 127,099 http://tinyurl.com/ybra4s69
8-29-17 8/4/17-8/15/17 +27,252 0 3,828,391 127,099 http://tinyurl.com/yay55u3p (14A)
10-10-17 8/16/17-10/10/17 +45,000 0 3,873,391 127,099 http://tinyurl.com/ybvkjd3e (14A)
10-17-17 10/13/17-10/16/17 +109,573 +1,000 3,982,964 128,099 http://tinyurl.com/y983myco
SPLITOUT 13D GROUP into Ronin(John Stafford III, R.Farley) & SW-Partners(Stephen White):
Ronin Trading (Stafford) 3,173,391 115,299 (beneficial=3,310,652)
Ronin’s Roger Farley 109,573 1,000 (beneficial=110,763)
SW-Partners (White) 700,000 11,800 (beneficial=714,047)
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Plus, INSTITUTIONS a/o 6-30-17: 7,476,857sh. = 16.6% <=incl. Tappan’s 8-14-17/13G,
...and KennedyCAP corrected 9,758,459=>1,394,066(Nasdaq R/S error)
...15,198,818 +(1,394,066-9,758,459) + (2,298,684-1,656,252) = 7,476,857
http://www.nasdaq.com/symbol/pphm/institutional-holdings
TOP7:
Tappan St. Partners 2,298,684 +1,384,380 <=per 8-14-17/13G(see below**)
Kennedy Capital Mgt. 1,394,066 +146,842
Vanguard Group 1,029,755 +146,791
Blackrock (Larry Fink) 806,022 -49,433
Renaissance Technologies 481,160 +41,487
Geode Capital Mgt. 225,679 +20,319
Bandera Partners 203,004 New
**8-14-17/13G: Tappan Street (Prasad Phatak) http://tinyurl.com/ybgqp9uq
2 Funds + P.Phatak’s personal shares:
...Partners LLC, Tappan St. Fund L.P. 1,540,000
...Tappan St. Partners Ideas Fund L.P. 691,577
...Prasad Phatak (Principle Owner) 67,107 Total TAPPAN: 2,298,684 (5.1%)
Note: Tappan Inst. Holdings a/o 3-31-17 was: 914,304, 1,656,252 at 6-30-17.
Huts, that Bexion Ph1/n=40 trial began Sept’16, using a “nanovesciles” drug named BXQ-350.
“Phase 1 Study of BXQ-350 [nanovesicles] in Adult Patients With Advanced Solid Tumors” (Open Label)
Sponsor: Bexion Pharmaceuticals, Covington, KY http://www.bexionpharma.com
Study Start Date: Sept. 2016; Est. Completion: Jan. 2019
https://clinicaltrials.gov/ct2/show/NCT02859857
BXQ-350 nanovesicle formulation [Saposin C-DOPS]:
...Saposin C + Lipid/Ceramide = “Nano Cell”
A stable, nanovesicle formulation composed of a synthetic form of the human glycoprotein saposin C (SapC) linked to the phospholipid dioleoylphosphatidylserine (DOPS), with potential antineoplastic activity. Upon intravenous administration, the BXQ-350 nanovesicle formulation selectively targets and preferentially accumulates in tumor vessels and cells, due to the leaky nature of tumor vasculature and the presence of phosphatidylserine (PS) lipids in tumor cell membranes. Upon binding to the phospholipids in the tumor cell membrane, SapC fuses with the membrane and is internalized leading to its accumulation within the internal membrane. SapC becomes active in the acidic tumor microenvironment and as a lysosomal sphingolipid activator protein, activates lysosomal enzymes, such as beta-glucosidase, acid sphingomyelinase, and beta-galactosylceramidase. This leads to the degradation of glucosylceramide and sphingomyelin, and the conversion of galactosylceramide to ceramide, respectively. This elevates intracellular ceramide levels, activates caspases and induces ceramide-mediated apoptosis, which together lead to an inhibition of tumor cell growth. SapC plays key roles in lipid transport and organization of biological membranes and has strong lipid membrane binding activity.
https://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=785725
Bexion's BXQ-350 MOA:
Stephen Worsley no longer listed on MGT. webpage (VP/Bus-Dev. since Nov. 2013)
http://www.peregrineinc.com/about-us/management-team.html
BTW, here too: http://avidbio.com/team/
Known Upcoming Events, Large-Shareholders(35%), RONIN-PPHM HISTORY: updated 10-10-17 with Ronin/SWIM’s 10-10-17 PR announcing they will nominate James J. Egan as their 4th BOD candidate and also calling on Peregrine to hold the 2017 ASM w/o further delay – see below. In addition, it shows that SWIM has added 45,000sh. Common since the last (8-29-17) 14A, taking Group total beneficial ownership from 3,979,699 to 4,024,699 (8.9% of 45,096,081 common outstanding as of 8-25-17).
NOTE: RONIN/SWIM’s 8-29-17 PRELIM. Proxy Statement (14A) and PPHM’s 8-28-17 Amended 10-K were added previously – see below...
KNOWN UPCOMING:
Sep25-28/Avid(booth #918): Informa’s BPI’17: BioProcess Intl. Conf. & Exhibition, Boston https://lifesciences.knect365.com/bioprocessinternational
Oct2/NCI Scientist Gregoire Altan-Bonnet(MSKCC ties), AACR’s Tumor Immunotherapy Conf., Boston http://tinyurl.com/y74v76go
...“Long-Lived Disruption of Inflammation Stems from the Catch-and-Release of Cytokines Mediated by Surface Phosphatidylserine in Tumors”
Oct6/Avid(booth): LakePharma Protein Eng. Symposium, So.SanFran http://tinyurl.com/ya6yvetk
~Oct12(??based on 2016): Peregrine's Annual Shareholder’s Meeting (2016 attendee reports: http://tinyurl.com/jx7ouay )
Nov8-12: 32th Annual SITC’17, Natl-Harbor MD http://tinyurl.com/ybfm75wj
...1. PPHM-PrecisionMed: “Results of Epigenetic-Based Quantitative PCR Assisted Immune Cell Counting Analysis in Bavi SUNRISE Trial Subgroup”
...2. MSKCC-PPHM: “PS-Targeting In Combo w/Rad+Immune Checkpoint Blockade Promotes Anti-Tumor Activity in Mouse B16 Melanoma”
Dec11-15/Avid Booth #311: KNect365’s Antibody Eng. & Therapeutics Conf., SanDiego https://lifesciences.knect365.com/antibody-engineering-therapeutics
~Dec11: FY'18Q2 (qe 10-31-17) Financials & Conf. Call - http://ir.peregrineinc.com/events.cfm
Jan18-22 2018: Phacilitate’s Immunotherapy World Forum, Miami http://www.immunotherapyforum.com
...Jan18 12:30-12:45, Joe Shan(VP/Reg+Clin): “Turning up the Heat: PS-Targeting Antibodies Modulate the Tumor Microenvironment & Enhance Checkpoint Blockade”
= = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
7-20-17: Large Ownership Summary(34.8%), RONIN Letters/PPHM Comments
Large Ownership now ~15.8mm shares, 35.0% of 45,096,081 O/S at 9-6-17. (Ronin+SW/Stafford+White, Eastern Cap./K.Dart, Institutions incl. Tappan’s 8-14-17/13G)
#1: 10-30-15: Kenneth Dart (Eastern Capital) acquires 9.5% stake (4,300,992sh.) in PPHM http://tinyurl.com/y95yskck
...3,777,183 COMMON – 8.4% of 45,096,081 common O/S at 8-25-17 (total beneficial=4,300,992 if Pref. conv. x1.1905 to Common, 9.5%)
...440,000 PREFERRED – 26.7% of 1,647,760 preferred O/S at 1-31-17
…...9-29-17/Form4: http://tinyurl.com/y9oadloa <=No chg. In Ownership; status update?
#2: 7-14-17/13D: Group Ronin Trading/SWInvest (John Stafford III+Stephen White) acquires 8.9% stake (4,024,699sh.) in PPHM http://tinyurl.com/y7ezqvm9
...3,873,391 COMMON – 8.6% of 45,096,081 common O/S at 8-25-17 (total beneficial=3,979,699 if Pref. conv. x1.1905 to Common, 8.8%)
...127,099 PREFERRED – 7.7% of 1,647,760 preferred O/S at 1-31-17
NOTE: ALL historical common #’s adjusted for the 1:7 R/S eff. 7-10-17.
RONIN/SW 13D SUMMARY:
13D TransDates COMMON-CHG PREF-CHG ENDING-COMMON ENDING-PREF.
3-2-17 1/20/17-3/1/17 +2,947,425 +51,364 2,947,425 51,364 http://tinyurl.com/jr42u23
3-10-17 3/2/17-3/9/17 +433,509 +25,661 3,380,934 77,025 http://tinyurl.com/ydxra96u
4-17-17 3/28/17-4/10/17 0 +23,334 3,380,934 100,359 http://tinyurl.com/lanjddc
5-19-17 5/1/17-5/17/17 0 +23,140 3,380,934 123,499 http://tinyurl.com/mgnn92x
6-20-17 3/10/17-6/16/17 +378,170 0 3,759,105 123,499 http://tinyurl.com/y76q5rqu
6-29-17 6/21/17 +7,143 0 3,766,248 123,499 http://tinyurl.com/y9sp8bfv
7-14-17 6/29/17-7/7/17 +34,891 +3,600 3,801,139 127,099 http://tinyurl.com/ybra4s69
8-29-17 8/4/17-8/15/17 +27,252 0 3,828,391 127,099 http://tinyurl.com/yay55u3p (14A)
10-10-17 8/16/17-10/10/17 +45,000 0 3,873,391 127,099 http://tinyurl.com/ybvkjd3e (14A)
SPLITOUT 13D GROUP into Ronin(John Stafford III) and SW-Partners(Stephen White):
Ronin Trading (Stafford) 3,173,391 115,299 (beneficial=3,310,652)
SW-Partners (White) 700,000 11,800 (beneficial=714,047)
- - - - - - - - - - - - - - -
Plus, INSTITUTIONS a/o 6-30-17: 7,476,857sh. = 16.6% <=incl. Tappan’s 8-14-17/13G,
...and KennedyCAP corrected 9,758,459=>1,394,066(Nasdaq R/S error)
...15,198,818 +(1,394,066-9,758,459) + (2,298,684-1,656,252) = 7,476,857
http://www.nasdaq.com/symbol/pphm/institutional-holdings
TOP7:
Tappan St. Partners 2,298,684 +1,384,380 <=per 8-14-17/13G(see below**)
Kennedy Capital Mgt. 1,394,066 +146,842
Vanguard Group 1,029,755 +146,791
Blackrock (Larry Fink) 806,022 -49,433
Renaissance Technologies 481,160 +41,487
Geode Capital Mgt. 225,679 +20,319
Bandera Partners 203,004 New
**8-14-17/13G: Tappan Street (Prasad Phatak) http://tinyurl.com/ybgqp9uq
2 Funds + P.Phatak’s personal shares:
...Partners LLC, Tappan St. Fund L.P. 1,540,000
...Tappan St. Partners Ideas Fund L.P. 691,577
...Prasad Phatak (Principle Owner) 67,107 Total TAPPAN: 2,298,684 (5.1%)
Note: Tappan Inst. Holdings a/o 3-31-17 was: 914,304, 1,656,252 at 6-30-17.
9-11-17 Qtly CC-Transcript, PR(Fin’s Q1FY18/qe7-31-17), Avid Revs History Table
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