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4-24-18/in-PharmaTechnologist article quotes Roger Lias
"Avid Plans Expansion With Focus On Biologics Development"
* There is no slowdown in sight, says Avid Bioservices CEO, as the company today announces further expansion to support new client projects and optimize its novel CHO-based expression system.
By Melissa Fassbender, in-Pharma Technologist.com
https://www.in-pharmatechnologist.com/Article/2018/04/24/Avid-plans-expansion-with-focus-on-biologics-development
"Roger Lias, CEO of Avid Bioservices said the company has seen a “tremendous surge” in interest since formally transitioning to a full-service, dedicated CDMO earlier this year. The company in February raised more than $20M to grow its contract mfg. business. Today, Avid announced [4-24-18: http://ir.avidbio.com/releasedetail.cfm?ReleaseID=1064742 ] that it is expanding its Orange County, CA-based process development laboratory space to more than 6,000sf. Conducting work in phases to avoid disruption, the first new laboratories are expected to be operational during Q3 of CY2018 [July-Sept’18].
Lias said: “Our announced expansion is driven by strong in interest in our process development & clinical stage services, but we are also in the unusual position of having multiple single use 2,000L bioreactors available in our state-of-art Myford facility.” This, “at a time when many competitors are starting expansion projects that will not yield available capacity until 2019 and beyond,” he added. In addition to upgrading its existing infrastructure, Avid is also installing new equipment to support client mfg. demand from clinical development to commercial production. The expansion will also support technology transfer and on-boarding of later stage mfg. projects, Lias said. “The final phase of the program will be the relocation of our pilot facilities into remodeled space within the company’s legacy Franklin mfg. facility,” he added.
NO SLOWDOWN IN SIGHT
Focusing on the development & manufacturing of biologics derived from mammalian cell culture, Lias said the company sees “no slowdown in broad demand for this class of products.”
Later this year, Lias said the company will be able to share addl. information about a novel CHO-based [Chinese Hamster Ovary] mammalian expression system that is being developed in-house. [Could this be Avid’s 2017 announced “ANTIBODY DISCOVERY PLATFORM”?? See below]
”Monoclonal antibodies and derivatives such as multi-specific antibodies and antibody drug conjugates remain hot areas, but we also see strong demand for complex recombinant proteins such as fusion proteins & enzymes based on our long track record with these highly glycosylated and complicated products,” he added.
The company recently signed new agreements with 3 intl. drug development companies for which Avid has commenced work. “The drug candidates involved in these agreements are being developed for application in certain cell therapy, respiratory and oncology indications,” said Lias.
With the recent agreements, the company has on-boarded 4 new client projects this year to date, compared to the same number in 2017.
*end*
4-24-18/PR: Avid adding Process Dev. Labs, upgrading capabilities (in phases; total will be >6000sq; 1st one ready Q3/CY’18(July-Sept'18). ”In recent weeks, Avid has signed new agreements with 3 addl. undisclosed intl. drug dev. companies (that’s 4 thus far in CY2018)”
http://ir.avidbio.com/releasedetail.cfm?ReleaseID=1064742
= = = = = = = = = = =
10K 4-30-17 iss. 7-14-17 http://tinyurl.com/ycxu4l5n
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.
...Pg6: FY'18 Objectives: Complete the evaluation process for the Antibody Discovery Platform and begin offering as a CDMO service through Avid Bioservices.
ALSO:
8-9-17/PR: PPHM commenced a restructuring plan… reduces workforce by 60(20%), reduced R&D from 22 to 11. http://tinyurl.com/ycrxq5tc
"As part of the cost saving initiatives, the Company reduced Peregrine's R&D personnel by 50% to 11 employees, with the remaining staff supporting potential strategic alternatives for its R&D assets while continuing to assist with collaborative trials, the antibody discovery platform, and the exosome program".
4-20-18: MSKCC Tweets re: Two AACR’18 PS-Targeting Posters. Both author blocks reference joint MSKCC(Wolchok/Merghoub)/”PPHM”(S.King/J.Shan) scientists.
Ludwig Cancer @Ludwig_Cancer https://twitter.com/ludwig_cancer
“Sara Schad, PhD graduate student at Ludwig @sloan_kettering, shares findings at #AACR18 on targeting Phosphatidylserine (PS) and making CAR-T cells more efficient in the treatment of solid tumors.”
AACR’18 April14-18 Abstracts: http://www.abstractsonline.com/pp8/#!/4562
4-17-18 8am-12pm: Session PO.CL06.03 - Adoptive Cell Therapy 3
#3568: “Phosphatidylserine Targeting Antibody Enhances Anti-tumor Activity of CAR T Cells in Mouse Melanoma”
4-17-18 8am-12pm
Sara Schad (Wolchok Lab), D. Hirschhorn-Cymerman 1, S. Budhu 1, H. Zhong 1, X. Yang 1, J. Shan 2, S. King 2, T. Merghoub 1, J. Wolchok 1
1=Mem. Sloan Kettering Cancer Ctr, NYC; 2=Peregrine Pharmaceuticals, Tustin
http://www.abstractsonline.com/pp8/#!/4562/presentation/7506
Excerpts: “Our lab has previously shown that a PS targeting monoclonal antibody (mch1N11), in combination with transgenic CD4+ T cells that recognize the melanoma antigen Trp1, can regress very advanced melanomas in all treated mice. Here, we further those studies with data showing that a 2nd-generation CAR T cell that binds Trp1 on the surface of B16 melanoma, in combination with mch1N11 can improve antitumor activity and overall survival in B16 tumor-bearing mice… Our studies may inform the design of clinical trials combining PS targeting antibodies with CAR T cell therapy in solid tumors.”
SARA SCHAD:
PhD Graduate Student, The Jedd Wolchok Lab: https://www.mskcc.org/research-areas/labs/members/sara-schad
4-20-18 TWEET:
= = = = = = = = = = = = = = = = = =
A 2ND AACR’18 MSKCC/”PPHM” PS-TARGETING ABSTRACT:
This one was Tweeted by MSKCC(Ludwig) 4-16-18: https://twitter.com/ludwig_cancer
“Rachel Giese, Taha Merghoub, and Jedd Wolchok of Ludwig MSK with their poster at #AACR18 on combining radiotherapy with an antibody against an immunosuppressive molecule to tackle #melanoma that resists checkpoint blockade.”
AACR’18 April14-18:
4-16-18 1-5pm: Session PO.IM02.03 - Immune Mechanisms Invoked by Therapies 1
#2767: “Phosphatidylserine Targeting & Radiation Improves Survival in a Mouse Tumor Model Resistant to Checkpoint Blockade”
Rachel Giese (Wolchok Lab), S. Budhu 1, C. Barker 1, A. Gupta 1, S. King 2, J. Shan 2, J. Wolchok 1, T. Merghoub 1
1=Mem. Sloan Kettering Cancer Ctr, NYC; 2=Peregrine Pharmaceuticals, Tustin
http://www.abstractsonline.com/pp8/#!/4562/presentation/7951
Excerpts: “RESULTS: Early triple combination therapy results in almost complete tumor elimination and leads to statistically significant prolonged survival. In the aPD-1 resistant cohort, both prior and continuous aPD-1 treatment with mch1n11+RT improved survival compared to all four controls. There was no significant difference in tumor size or survival between the adjuvant and alternative experimental groups. Experiments are ongoing to characterize immune infiltrates of tumors and the individual effects of aPD-1, RT and mch1n11.
CONCLUSION: This preclinical model suggests a phosphatidylserine targeting antibody combined with single dose RT presents an alternative or adjuvant therapy for tumors resistant to checkpoint blockade. The data from this preclinical model will be used to develop a clinical trial for patients with tumors resistant to checkpoint blockade.”
4-16-18 TWEET:
IR/4-11-18: "Wells-Fargo has not dropped coverage of Avid.”
Per Cheynew 4-12-18:
From IR (Stephanie Diaz):
“Tim Evans left Wells Fargo for another firm. However, Wells Fargo has not dropped coverage of Avid.”
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=139985790
Ronin 13D/4-17-18: beneficial shares drop to 2,638,450 (4.7% of 55,552,233 O/S at 3-7-18), down 1,043,916 from 3,682,366 a/o the last 13D/4-6-18.
Also, “eff. 4-14-18, Ronin/Farley (‘Ronin Group’) terminated their oral agreement w/Stephen White (SW Investment Mgt./SWIM Partners) to act as a group for purposes of Reg.13D. Stephen White/SWInvest/SWIM ceased to be members of the 13D Group and shall cease to be Reporting Persons immediately upon the filing of this Amendment #13 to the Schd. 13D”.
A/o 4-17-18(Amend13): [SW/S.White Leaves 13D Reporting Group) https://tinyurl.com/y6uvofqv
SPLITOUT 13D GROUP into Ronin(John Stafford III, R.Farley):
ENDING-COMMON ENDING-PREF.
Ronin Trading (Stafford) 2,225,000 115,299 (beneficial=2,362,260)
Ronin’s Roger Farley 275,000 1,000 (beneficial=276,190)
**TOTAL Ronin+Farley: 2,500,000 116,299 (beneficial=2,638,450)
A/o 4-6-18(Amend11): https://tinyurl.com/yb2hgmeh
SPLITOUT 13D GROUP into Ronin(John Stafford III, R.Farley) & SW-Partners(Stephen White):
Ronin Trading (Stafford) 3,234,916 115,299 (beneficial=3,372,176)
Ronin’s Roger Farley 309,000 1,000 (beneficial=310,190)
SW-Partners (White) 517,000 11,800 (beneficial=531,047)
**TOTAL Ronin+SW+Farley: 4,060,916 128,099 (beneficial=4,213,413)
A/o 2-15-18(Amend10): https://tinyurl.com/ych9aspz
SPLITOUT 13D GROUP into Ronin(John Stafford III, R.Farley) & SW-Partners(Stephen White):
Ronin Trading (Stafford) 4,040,000 115,299 (beneficial=4,177,260)
Ronin’s Roger Farley 275,000 1,000 (beneficial=276,190)
SW-Partners (White) 727,000 11,800 (beneficial=741,047)
**TOTAL Ronin+SW+Farley: 5,042,000 128,099 (beneficial=5,194,497)
Ronin/SW 13D/4-6-18: beneficial shares drop to 4,213,413, down 981,084 from the last 13D/2-15-18.
Ronin 13D/Amend11 filed 4-6-18): https://www.sec.gov/Archives/edgar/data/704562/000110465918022868/a18-9710_1sc13da.htm
A/o 4-6-18(Amend11):
SPLITOUT 13D GROUP into Ronin(John Stafford III, R.Farley) & SW-Partners(Stephen White):
Ronin Trading (Stafford) 3,234,916 115,299 (beneficial=3,372,176)
Ronin’s Roger Farley 309,000 1,000 (beneficial=310,190)
SW-Partners (White) 517,000 11,800 (beneficial=531,047)
**TOTAL Ronin+SW+Farley: 4,060,916 128,099 (beneficial=4,213,413)
Ronin 13D/Amend10 filed 2-20-18: https://www.sec.gov/Archives/edgar/data/704562/000110465918010802/a18-6489_1sc13da.htm
A/o 2-15-18(Amend10):
SPLITOUT 13D GROUP into Ronin(John Stafford III, R.Farley) & SW-Partners(Stephen White):
Ronin Trading (Stafford) 4,040,000 115,299 (beneficial=4,177,260)
Ronin’s Roger Farley 275,000 1,000 (beneficial=276,190)
SW-Partners (White) 727,000 11,800 (beneficial=741,047)
**TOTAL Ronin+SW+Farley: 5,042,000 128,099 (beneficial=5,194,497)
Addition to Russell3000 (cutoff: 5-11-18) looking good, based on R3000 up ~8% since last year’s rank date (5-12-17).
Russell3000 Cutoffs:
2015: $176.7M
2016: $132.9M
2017: $143.6M
2018: a/o 4-2018, UP ~8% => ‘18 cutoff EST. = ~$156M (based on 5/12/17 – 4/3/18)
http://www.ftserussell.com/research-insights/russell-reconstitution/market-capitalization-ranges
CDMO Mkt. Cap a/o 4-3-18 = ~$178M (Shares O/S = 55,552,233)
https://finance.yahoo.com/quote/CDMO?p=CDMO
R3000 INDEX Quote:
https://www.marketwatch.com/investing/index/rua
5-12-17: 1,416
4-3-18: 1,534 +8.3%
RUSSELL ANNUAL RECONSTITUTION
Rank Day 2017: 5-12-17
Rank Day 2018: 5-11-18 (take effect 6-25-18)
http://www.ftserussell.com/index-series/index-resources/russell-reconstitution
The Mgr/Dir./Bus.Dev/East-Coast-based opening now gone from website. The VP/Process-Sciences job disappeared 3-13-18.
Down from 4 to these 2:
...Manager/Sr.Mgr., Risk Assessment (QA)
...Specialist/Sr.Specialist, Downstream Mfg. Quality Sciences
https://avidbio.com/careers
= https://avidbio.applicantpro.com/jobs
3-12-18/R.Lias: “At present, we are in late-stage negotiations with several potential new customers and expect to announce the executed agreements before the end of the FY [4-30-18].”
https://tinyurl.com/yakdl4wj
3-23-18: 1st-Analysis & WellsFargo Coverage added to website:
http://ir.avidbio.com/analysts.cfm
First Analysis Securities - Steven Schwartz, CFA
NOBLE Life Science Partners - Caroline Palomeque
Wells Fargo Securities - Tim Evans [Sr. Analyst]
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3-13-18: Avid Bioservices initiated @Overweight/$4 by First Analysis
First Analysis analyst Steven Schwartz [and 2nd analyst, Tracy Marshbanks] started Avid Bioservices with an Overweight rating and $4 price target. The analyst views the company as a "compelling opportunity for investors with a longer-term investment horizon." He views current valuation levels as attractive and sees revenue growth rates eventually exceeding 10% with faster profit growth driven by scale efficiencies.
StreetInsider: “Analyst Schwartz sees a successful shift to a pure-play CDMO.”
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=139264676
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3-15-18: “Wells Fargo Starts Avid Bioservices (CDMO) at Outperform, 'A Biologic Contract Manufacturing Pure Play'”
Wells Fargo [Avid website says: Tim Evans] initiates coverage on Avid Bioservices (NASDAQ: CDMO) with an Outperform rating and a price target of $3.50.
StreetInsider.com: https://tinyurl.com/yd2c3e83
RESEARCH: https://www.wellsfargo.com/com/securities/research
https://www.wellsfargoresearch.com/Public
TipRanks:
https://www.tipranks.com/analysts/tim-evans
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3-17-18: First Analysis forecasts Avid Bioservices Inc (CDMO) Forecasted to Earn FY2018 Earnings of ($.69)/share
Posted by Andrew Steele
https://stocknewstimes.com/2018/03/17/avid-bioservices-inc-cdmo-forecasted-to-earn-fy2018-earnings-of-0-69-per-share.html
Stock analysts at First Analysis issued their FY2018 earnings/sh. (EPS) estimates for Avid Bioservices (CDMO) in a research note issued to investors on 3-13-18. They anticipate that the biopharmaceutical company will post earnings of ($.69)/sh. for FY’18. First Analysis currently has an “Overweight” rating/$4.00/PT. Est’s for Avid Bioservices:
Q4/FY’18 ($.08)
...FULL FY’18: ($.69) - FY’18 ends 4-30-18
Q1/FY’19 ($.06)
Q2/FY’19 ($.05)
Q3/FY’19 ($.03)
Q4/FY’19 ($.01)
...FULL FY’19: ($.15) - FY’19 ends 4-30-19
RL: “The PS-targeting Exosome-Tech: Back to UTSW.”
3-12-18/CC/Roger Lias: “Not included in the Oncologie deal is the PS-targeting Exosome technology, which is being returned to UTSW.” https://tinyurl.com/yakdl4wj
3-15-18: Wells Fargo Starts Avid (CDMO) at Outperform/PT=$3.50
3-15-18: “Wells Fargo Starts Avid Bioservices (CDMO) at Outperform, 'A Biologic Contract Manufacturing Pure Play'”
Wells Fargo initiates coverage on Avid Bioservices (NASDAQ: CDMO) with an Outperform rating and a price target of $3.50.
StreetInsider.com: https://tinyurl.com/yd2c3e83
RESEARCH: https://www.wellsfargo.com/com/securities/research
https://www.wellsfargoresearch.com/Public
3-17-18: First Analysis’s EPS Est’s for next 5qtrs. Where does a coverage company like First-Analysis come up with their numbers? Thru discussions with mgt? Just Swags? (assuming stocknewstimes is reporting accurately). I wish we could get the Wells Fargo estimates for comparison.
3-17-18: First Analysis forecasts Avid Bioservices Inc (CDMO) Forecasted to Earn FY2018 Earnings of ($.69)/share
Posted by Andrew Steele
https://stocknewstimes.com/2018/03/17/avid-bioservices-inc-cdmo-forecasted-to-earn-fy2018-earnings-of-0-69-per-share.html
Stock analysts at First Analysis issued their FY2018 earnings/sh. (EPS) estimates for Avid Bioservices (CDMO) in a research note issued to investors on 3-13-18. They anticipate that the biopharmaceutical company will post earnings of ($.69)/sh. for FY’18. First Analysis currently has an “Overweight” rating/$4.00/PT. Est’s for Avid Bioservices:
Q4/FY’18 ($.08)
...FULL FY’18: ($.69) - FY’18 ends 4-30-18
Q1/FY’19 ($.06)
Q2/FY’19 ($.05)
Q3/FY’19 ($.03)
Q4/FY’19 ($.01)
...FULL FY’19: ($.15) - FY’19 ends 4-30-19
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3-13-18: Avid Bioservices initiated @Overweight/$4 by First Analysis
First Analysis analyst Steven Schwartz [and 2nd analyst, Tracy Marshbanks] started Avid Bioservices with an Overweight rating and $4 price target. The analyst views the company as a "compelling opportunity for investors with a longer-term investment horizon." He views current valuation levels as attractive and sees revenue growth rates eventually exceeding 10% with faster profit growth driven by scale efficiencies.
StreetInsider: “Analyst Schwartz sees a successful shift to a pure-play CDMO.”
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=139264676
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3-15-18: “Wells Fargo Starts Avid Bioservices (CDMO) at Outperform, 'A Biologic Contract Manufacturing Pure Play'”
Wells Fargo initiates coverage on Avid Bioservices (NASDAQ: CDMO) with a Outperform rating and a price target of $3.50.
StreetInsider.com: https://tinyurl.com/yd2c3e83
RESEARCH: https://www.wellsfargo.com/com/securities/research
https://www.wellsfargoresearch.com/Public
3-13-18: Avid Bioservices initiated @Overweight/$4 by First Analysis
First Analysis analyst Steven Schwartz started Avid Bioservices with an Overweight rating and $4 price target. The analyst views the company as a "compelling opportunity for investors with a longer-term investment horizon." He views current valuation levels as attractive and sees revenue growth rates eventually exceeding 10% with faster profit growth driven by scale efficiencies.
https://thefly.com/landingPageNews.php?id=2698728
First Analysis Securities Corp. - https://www.firstanalysis.com
EQUITY RESEARCH: https://www.firstanalysis.com/Equity-Research.aspx
Steven Schwartz: https://www.firstanalysis.com/Equity-Research.aspx?cid=39
Companies: https://www.firstanalysis.com/Equity-Research.aspx?cid=40
2nd First Analysis Analyst Tracy Marshbanks:
CEO Roger Lias’ Roth Webcast begins in 5mins...
Mar13/Roger Lias: 30th Annual Roth Conf., Laguna Niguel http://www.roth.com/main/page.aspx?PageID=7290
...2pmPT/5pmET: Corp. presentation, WEBCAST (wsw.com): https://tinyurl.com/y9keay3u
https://avidbio.com => http://ir.avidbio.com/events.cfm
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3-12-18: Qtly. Conf. Call (Lias/Kinjerski/Lytle) PR & Transcript https://tinyurl.com/yakdl4wj
VP/Process-Sciences job gone from website. Was there yesterday.
https://avidbio.com/careers
= https://avidbio.applicantpro.com/jobs
Here are some Events I’m looking fwd to – and their future effect on CDMO’s share price.
3-12-18/R.Lias: “I'm pleased to be able to report that in a very short period of time we've generated significant interest from both emerging & growth biopharmaceutical players and from pharmaceutical multinationals... I'm confident that the plan we're executing will drive a considerable increase in backlog and the opportunity to further enhance capacity utilization in the future.”
3-12-18/R.Lias: “At present, we are in late-stage negotiations with several potential new customers and expect to announce the executed agreements before the end of the FY [4-30-18].”
3-12-18/T.Kinjerski: “I'm happy to announce that within the past week, 2 addl. new clients have announced their intent to execute master service agreements with Avid.”
3-12-18/T.Kinjerski: “We also continue to engage with multiple potential customers regarding their later-stage and commercial mfg. needs. It is std. that the due diligence surrounding later-stage contracts encompasses a larger but longer decision cycle on the part of the client than early stage projects. We are qualified and well-positioned to win a number of these later stage projects for which we're currently in discussions. While we are not in a position to publicly disclose such potential partners at this time, we believe it's important to communicate the scale of our efforts.”
Source: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=139248929
- - - - - - - - - - - - -
IN ONE HOUR TODAY:
Roger Lias WEBCAST(ROTH Conf.) 3-13-18 2pmPT/5pmET: https://tinyurl.com/y9keay3u
http://ir.avidbio.com/events.cfm
3-12-18 Qtly CC-Transcript, PR(Fin’s Q3FY18/qe1-31-18), Avid Revs History Table
=> Avid Total Revs May03-Jan18: $288.6mm
*Revs Guidance (FY’18 fye 4-30-18): $50-55mm. Committed B/L=$39mm at 1-31-18.
*Cash: 1-31-18: $17.9mm; 2-28-18: $41.7mm
*As of Mar. 7, 2018, 55,552,233 shares o/s.
*10Q/1-31-18 iss. 3-12-18: https://tinyurl.com/yd4orsg7
*Avid’s website: https://avidbio.com
**Upcoming Roger Lias WEBCAST(ROTH) 3-13-18 2pmPT/5pmET: https://tinyurl.com/y9keay3u
This large post has 4 sections:
I. 3-12-18 Q3/FY18 Qtly. Earnings Conf. Call TRANSCRIPT (q/e 1-31-18)
II. 3-12-18 CDMO Press Release: Q3/FY18 Earnings & Developments
IV. Updated Table of Avid Revenues By Quarter (May’06-Current)
III. Updated O/S Shares History Table – 2006-curr.
…Recall: Avid’s FY runs May-Apr, so FY’18 = May’17-Apr’18.
((( Orig. transcript from SeekingAlpha.com [https://tinyurl.com/yckfrhxs ], with numerous corrections made. )))
Link to webcast replay: http://ir.avidbio.com/events.cfm => https://edge.media-server.com/m6/p/mnzedx6d
FULL TRANSCRIPT… 3-12-18 FY’18/Q3 Earnings Conf. Call (q/e 1-31-18) (Lias/Kinjerski/Lytle)
WELCOME & FWD-LOOKING STATEMENTS: Tim Brons, Vida Strategic Partners (IR)
ROGER LIAS (CEO) – OPENING COMMENTS:
Thank you, Tim, and thanks to all of you who've dialed in and all of you who are participating today via webcast. During our Q2 earnings call back in December, I outlined a number of ambitious objectives, all designed to transition Peregrine Pharmaceuticals into a dedicated CDMO business. Three months later, I am very pleased to announce that Avid has completed these key objectives.
First, in January, we changed the name of the company from Peregrine Pharmaceuticals to Avid Bioservices, and also changed our NASDAQ ticker symbol to CDMO. We successfully divested the company's lead immuno-oncology assets to an organization with the financial resources & expertise to further develop them. We have established a new operational structure that will allow our business to take full advantage of the substantial & growing demand for biologics manufacturing. And lastly, we executed a financing round, raising gross proceeds of more than $23mm. These funds will be used to grow and enhance our CDMO business, including the strengthening of our process development capabilities. Not only does process development work represent an attractive and profitable business opportunity in its own right, but it is crucial for on-boarding new projects that we anticipate will generate a pipeline of future cGMP mfg. opportunities.
I would like now to discuss the R&D asset divestiture. Last month, Avid successfully entered into an asset assignment and purchase agreement with Oncologie Inc. for the company's PS-targeting program [2-12-18: https://tinyurl.com/yam8gb3h ] . In addition to bavituximab, the deal included Avid's other PS-targeting antibody derivates, including beta bodies and certain other assets and licenses useful for the potential commercialization of bavituximab. Not included in the deal is the PS-targeting Exosome technology, which is being returned to UTSW. Under the terms of the Oncologie agreement, Avid will receive an aggregate of $8mm in upfront payments. These will be made over a period of 6mos. from the execution date of the agreement, and we expect to receive our initial payment of $3mm within the next few days. The deal also makes Avid eligible to receive up to $95mm in development, regulatory, and commercialization milestones. Oncologie will be responsible for all future research, development, and commercialization costs and activities, including intellectual property costs, and with Avid receiving royalties on net sales that are upward tiering into the mid-teens. The deal also requires Oncologie to enter into an agreement with Avid for future contract dev. & mfg. activities in support of bavituximab. We are very pleased to have reached this important agreement with Oncologie. This deal places Avid’s legacy R&D assets in very capable hands, while providing additional capital, both upfront and potentially downstream, to support our CDMO business. Importantly, the Oncologie deal marks the completion of Avid's transition to a dedicated CDMO business, and our team is now fully engaged in the work of expanding and diversifying our customer base and enhancing our services.
Following my comments, Tracy will discuss the very rapid progress we have made in this effort. But first, I’d like to provide a brief overview of the biologics mfg. market that drives our optimism for the future of Avid Bioservices. By 2022, the biologics drug market is anticipated to increase to approx. $326B annually, and biologics are predicted to comprise more than half of the top 100 drug sales worldwide. Growth is anticipated to continue at a compound annual growth rate of 10%. Within this market, protein drugs, such as monoclonal antibodies, continue to dominate, and mammalian cell culture base manufacturing, of the types that we provide at Avid, has become the preeminent technology used in the manufacturing of these highly complex biopharmaceutical products. In 2016, biologics based on mammalian cell culture technology represented 87% of sales of marketed products, as compared to those based on microbial fermentation technology. And this percentage is forecast to further increase to 92% by 2020. Given its backdrop, the CDMO industry has also experienced substantial growth over the past few years, with a predicted compound annual growth rate of 13% from 2015 to 2020. Growth projected from mammalian biologics manufacturing is particularly strong. Demand for commercial mfg. capacity for biologics derived from mammalian systems, including biosimilars, is expected to rise from 2 million liters in 2016 to approx. 3.5 million liters in 2020. The availability of facilities offering this production capacity is limited. While many organizations would like to take advantage of current market demand, the lengthy process of designing, constructing, equipping and validating these facilities requires significant expertise and capital investment which function as formidable barriers to entry into the CDMO market.
For all of these reasons, we believe that Avid is exceptionally well positioned to address the market, with numerous strongly differentiating advantages, which include a virtually unmatched 25 years of expertise & experience in developing a manufacturing biologics, a comprehensive range of services to support customers from early stage development through to commercialization, our customer-centric approach, our agile manufacturing & development capabilities, which include comprehensive analytical and characterization services, and our cost effective solutions which are facilitated by state-of-the-art facilities which feature modular clean room design, single-use bioreactors, and other disposable technologies employed throughout the production cycle.
It is Avid's excellent regulatory track record, however, that is perhaps our strongest advantage & differentiator. Historically, developing the expertise to comply with stringent regulatory audits and validation requirements has been a challenge for both biopharmaceutical companies and CDMOs alike. Customers place a premium on working with CDMOs that can ensure high degree of regulatory compliance, which decreases execution risk. This applies not only to customers approaching the typically large scale commercial manufacture, but also to those in process development or earlier clinical manufacturing stages who want to avoid the need for an expensive and technically risky future transfer to more experienced CDMO to support their pre-approval inspections and market supply. In my experience in this industry, I believe our track record to be virtually unparalleled, which consists of 15 years history of inspection by global regulatory authorities with no significant impact on our business or that of our customers. In addition, between 2005 and 2017, we completed 6 successful pre-approval inspections, and between 2013 and the present, we've also hosted 4 routine FDA inspections, including the latest unannounced inspection which was completed last month. None of these resulted in any Form 483 observations, and indeed the most recent inspection resulted in no observations of any kind. In addition to the FDA, we've also completed inspections by the European EMA, Brazil's ANVISA, Health Canada, The California Dept. of Health, the Australian Dept. of Health, and Turkish authorities. And finally, we regularly successfully comply with audits from large pharmaceutical companies, which are often more rigorous than those of the regulatory agencies. Given this track record & landscape, we believe Avid has a significant opportunity to drive organic growth by leveraging our strengths, broadening our capabilities, increasing our capacity, and improving our market visibility and reach. To this end, we have taken, and continue to take steps, to diversify and expand our customer base. We are executing marketing and sales strategies designed to drive new client acquisitions, while also continuing to pursue addl. collaborations with our existing customers.
I'm pleased to be able to report that in a very short period of time we've generated significant interest from both emerging and growth biopharmaceutical players and from pharmaceutical multinationals. I'm confident that the plan we're executing will drive a considerable increase in backlog and the opportunity to further enhance capacity utilization in the future. So with that background, I'd like to hand over the call to Tracy Kinjerski for an overview of the specific steps we've taken during and subsequent to Q3 FY’18 on our pathway to achieving our growth & operational objectives.
TRACY KINJERSKI (VP/Bus.Operations) – OPENING COMMENTS:
Thank you, Roger. Since joining the company in November [11-29-17: https://tinyurl.com/yc4zenkc ], I've had the pleasure of meeting and speaking with a number of our investors, and I'm pleased to be participating in my first earnings call for Avid. As Roger outlined, the market opportunity for biologics manufacturing is significant and growing. And our expertise, facilities, and regulatory track record position Avid for leadership in this landscape.
Since coming on board, my priority has been to strengthen our business systems and to expand and diversify our customer base in order to meet our revenue goals. As we ramp up our efforts to attract new business to Avid, it is critical that we strengthen our operational processes and systems to ensure that the company is capable of providing customers with an optimal experience at every stage of their interaction with our team. Specifically, we have taken steps to coordinate business development and project mfg. functions with our teams working closely together in order to best manage and advance all client-basing activities. For example, this includes the issuing of proposals and negotiating contracts. We have also implemented additional procedures across the organization, spanning all stages of work, to ensure that each functional team has full visibility regarding the status of existing projects and new projects in the queue. For example, these efforts have resulted in customized site visits designed to optimize technical discussions and the tour experience for each potential new customer, with smooth and efficient transfer of newly signed projects from the business development team to the assigned project manager and a tight alignment between marketing, BD, and project mgt. groups in order to best promote our progress and successes to the outside industry. This last effort is particularly important as our marketing group is in the first interface with the new customer and their close coordination with both business development and project management facilitates more accurate and comprehensive interactions. Also critically important are the multiple changes we've made with respect to our customer contracts & legal engagements. Going forward, our master service agreements will commit clients to longer term project scopes with industry standard reservation fees and cancellation provisions. This will, in time, provide a more complete forward-looking financial picture for the company.
We also have modified our approach to passing through material cost to clients to include deposits paid against lead times that equitably balance cash flow. These contractual changes enable improved security & assurance for our clients and provide multiple benefits to Avid. For Avid, our new contract & work statement documentation allows the company to provide a more comprehensive backlog, improved resource allocation, and gains the visibility we need to project revenues and project expansion needs. From the client perspective, in addition to reducing administrate burden, the system provides assurances that capacity will be available when needed and offers long-term visibility & security for their mfg. projects.
With our internal systems strengthened, we are actively ramping up our business development effort and building visibility in the industry. Concurrent with our announcement of Avid as an independent CDMO at the J.P. Morgan Healthcare Conference in January, we launched our new logo and new tagline with other initiatives that are creating brand awareness and driving demand. Renewed marketing efforts have successfully brought new inquiries to Avid, and it is clear that our efforts are having the desired impact in our market. In fact, in the first 3 months of 2018, we've received more than 10 new RFPs from potential clients as a result of new discussions & meetings. These represented all project phases, early and late, and include commercial manufacture. The client demographics range from biotechnology companies to multinational pharmaceutical companies. Furthermore, in the last 2 months, Avid has been notified that we have been awarded projects by multiple clients, and I'm happy to announce that within the past week, two additional new clients have announced their intent to execute master service agreements with Avid.
Two other clients, in particular, recently allowed us to announce specific details of the projects we're undertaking on their behalf. I'd like to provide a little more detail on these customer relationships. First, I'd like to comment on the Enzyvant project. Enzyvant, a subsidiary of Roivant Sciences, selected Avid as the commercial drug substance manufacturer for RVT-801, its a recombinant enzyme replacement therapy for Farbers disease. Though it was only recently announced, successful technology transfer and clinical manufacturing have been underway since mid-2017. Avid is undertaking process characterization and optimization in support of Enzyvant's ongoing developments and regulatory activities for RVT-801. Because of this molecule’s indication, it’s expected to progress very rapidly to process validation in support of pivotal trials and commercial launch. In addition, last month Acumen Pharmaceuticals selected Avid to provide process development and clinical mfg. services in support of ACU193, being developed for the treatment of Alzheimer's disease. Avid and Acumen will immediately commence process development work, with the goal of creating a robust cost-effective and scalable process to support cGMP manufacture. The Acumen contract represents in earlier stage project which supports our near-term revenue and profitability goals, as well potentially advancing to larger scale, later-stage manufacturing opportunities in the future.
We also continue to engage with multiple potential customers regarding their later-stage and commercial mfg. needs. It is standard that the due diligence surrounding later-stage contracts encompasses a larger but longer decision cycle on the part of the client than early stage projects. We are qualified and well-positioned to win a number of these later stage projects for which we're currently in discussions. While we are not in a position to publicly disclose such potential partners at this time, we believe it's important to communicate the scale of our efforts.
2018 is off to a great start with a very positive market feedback. From a business dev. perspective, we continue to focus our efforts proactively on the North America client base, but have, without dedicated effort, also attracted the attention of global companies, as well as smaller biotechnology companies outside of the North American region. Our business dev. will include one West Coast and one East coast representative, with Roger and myself continuing to actively support the recruitment of new clients.
In closing, I believe our business development activities and operational improvements have positioned us well to take full advantage of the growing demand in the biologics mfg. market. We are confident that our growing book of new, and potential new, business positions us on the path to leadership in the industry, as well as substantial and sustainable revenue growth. With that, I'll turn the call over to Paul to discuss our recent corp. achievements and financial highlights.
PAUL LYTLE (CFO): [1-31-18 10Q iss. 3-12-18: https://tinyurl.com/yd4orsg7 ]
I'll now discuss our financial results for Q3/FY18, starting with revenues. As discussed in the last call, we expected to generate $10-15mm in aggregate revenue during Q3 & Q4 of FY’18, currently due to lower demand for services from our two largest customers. During Q3/FY’18, we recognized $6.8mm in revenue, and we remain on track to achieve $50-55mm revenue for the full FY18. Though Q3 revenue was down compared to the same prior year period, the team is making important progress and diversifying and expanding our customer base, as Tracy just discussed. And our current revenue backlog has increased to $39mm representing signed commitments from our customers.
While we have these signed commitments, it's important to discuss that the way we recognize revenue from this backlog is going to change in FY’19 [May’18-Apr’19]. On May 1, 2018, the beg. of FY’19, we will be adopting the new revenue recognition standards, commonly referred to as ASC606, and this new standard will have a significant impact on the timing of revenue recognition going forward. As a backdrop, today we recognize 100% of our revenue at a single point in time, and in general that point in time represents the date when all deliverables are completed. As an example, revenue from a mfg. run is recognized when the drug substance is shipped from our facility and all other deliverables have been completed. Starting May 1, 2018, the new revenue recognition standard will require us to recognize revenue over a period of time for the majority of services we provide, including mfg. Services. For that same example mentioned above, during FY'19 revenue will be recognized over the entire mfg. process which is typically a 4-mo. Period, and the amount of revenue we recognize will be based on a percentage of completion at the end of each period.
There are a few important points I'd like to discuss regarding the adoption of ASC606. First, we plan to adopt this standard on a modified retrospective basis. For FY'19, our statement of operations will report revenue under the new standard based on a percentage of completion from the majority of our revenue, and we will separately disclose the amount of revenue we would have recognized during FY'19 under the current point-in-time method. In addition, on May 1, 2018, we will analyze all partially-completed and in-process customer projects and the amount of revenue we can recognize in FY'19 will only include the percentage of revenue not completed as of April 30, 2018. As an example, if we are 40% complete with $1mm mfg. project as of April 30, 2018, then the amount of revenue we can recognize in FY'19 would be equal to 60% of $1mm or $600,000 under ASC606. The amount of revenue and related cost of goods allocated to the period prior to May 1, 2018, will be reported as a one-time adjustment to retained earnings on May 1, 2018.
Let me shift gears now to discuss our gross margins on contract mfg. revenue. During Q3, gross margin declined to a negative 61%. This was mostly driven by idle capacity during the quarter in the amount of $5.3mm. When we exclude this idle capacity from our gross margin calculations, gross margin for the quarter improved to 17%. While this margin is well below our expectations for the business going forward, our margins are highly dependent on manufacturing capacity utilization. We have looked to improve our gross margins, in addition to focusing and growing our customer base and backlog to enhance capacity utilization, we continue to evaluate our overall cost structure to better match it with the future needs of the business. Now turning to expenses; total SG&A expenses for Q3 FY’18 were $4.8mm, compared to $4.4mm for Q3 FY’17. The current qtr increase was mostly driven by increases in legal and other related fees associated with the settlement agreement reached in November regarding the composition of the Board of Directors and the sale of PS-targeting assets.
With are recent sale of the PS-targeting assets, we have now fully transitioned to a dedicated CDMO. Accordingly, the operating results of our R&D business are now reported separately as a loss and discontinued operations for all periods presented in the statement of operations. Company's consolidated net loss attributable to common stockholders was $12.4mm or $.28/share for the Q3 FY’18, compared to $9.2mm or $.25/share for the same prior year qtr. Cash & cash equivalents as of Jan. 31, 2018 were $17.9mm, compared to $46.8mm at the FY end 4-30-17. Following the completion of the public offering last month, cash & cash equivalents increased to $41.7mm as of Feb. 28, 2018. In closing, I would like to suggest that all participants review our close of report on Form 10-Q [https://tinyurl.com/yd4orsg7 ], which was filed today, for addl. details on the company's financial payments and its result of operations. This concluded my financial overview. I will now open the call up for questions.
Q&A: [beg. 24:26]
1. Caroline Palomeque - Noble Life Science Partners http://noblelsp.com/research
CP: ”With all your new contracts in place, do you expect the cost of contract mfg. to increase and then level out, or are you expecting to sort of create synergies and have that decrease overall? And I mean as a percentage of revenue.”
Paul Lytle: I think our overall capacity can handle a significant addl. amount of revenue based on our current operations. So we don’t anticipate the cost of contract mfg. to go up as our business increases. We have sufficient infrastructure right now to maintain a significant amount of revenue, including we had about $58m in revenue we recorded in last FY, and I think we can get there with the current operations and headcount that we have currently. With that said, there will always be an increase in the cost related to raw materials from our customers, but that’s a pass-through cost, but our overall operating expenses should be relatively consistent from yr-to-yr to support increased mfg. revenue.
CP: ”Re: Cash, could talk a little bit about your runway and what you expect that to go up to?”
Paul Lytle: As we mentioned in the 10-Q, we believe we have sufficient cash on hand right now to operate our business for at least 12mos., based on the current cash on hand, and then that does not include bringing in any new business or any other sources of capital. So, we think we have a strong balance sheet right now to fund the business going forward.
CP: ”I know you've been expanding your customer base and it seems to be going really well, just wondering what some of the outside markets were, and I think Roger, you mentioned the few ex-U.S. countries, and I was just wondering if you could just elaborate on that. And do you see any trends in certain areas vs. others?”
Roger Lias: I don't think we have sufficient interest from outside the U.S. at the moment to really be able to declare any trends, but certainly we're getting interest from both Europe and Southeast Asia. There have been a few that have been sort of unsolicited, some of these are driven by previous contacts that both Tracy and I have in the industry. I think we are a long away from both places, but there are always good reasons to manufacture in certain territories. So, in one particular case, we know we have a client that needs specifically U.S. manufacturer for their product; I'm not entirely sure of the reasoning. So, we certainly can't declare any trends, but I think we can anticipate further interest from both Europe and Southeast Asia.
DR. LIAS’S CLOSING COMMENTS:
I'd like to thank you all for participating in today's call. And as always, I'd like to thank all of our stockholders both long-term and new for your continued support. And before signing off, I'd like to acknowledge, Paul Lytle, who has recently announced his resignation, as many of you know, effective in mid-May. Paul was instrumental in the founding of Avid as a subsidiary of Peregrine way back in 2002. We certainly wish to thank him for his more than 20 years of service to the organization. I know Paul is tough to replace, but a search has been commenced for his successor, and we look forward to providing news on that soon. So with that, we will conclude the call. Thank you all for dialing-in, or listening in on the webcast, and have a good afternoon. Thank you.
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3-12-18/PR: Avid Bioservices Reports Financial Results for Q3/FY2018 and Recent Developments
* Company Remains on Target for Full Year Revenue of $50-55 Million [FY18: fye 4-30-18]
* Intensified Business Development Effort Results in New Customer Contract and Strengthened Backlog
http://ir.avidbio.com/releasedetail.cfm?ReleaseID=1060611
TUSTIN, March 12, 2018: Avid Bioservices, Inc. (NASDAQ:CDMO/CDMOP), a dedicated contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, today announced financial results for the third quarter of fiscal year (FY) 2018 ended January 31, 2018, and provided an update on its contract manufacturing operations, and other corporate highlights.
HIGHLIGHTS SINCE OCTOBER 31, 2017
“During and subsequent to our Q3/FY18, Avid completed two primary objectives. We successfully divested the company’s lead immuno-oncology assets to an organization with the financial resources and expertise to advance them, and we established a new operational structure that will allow our business to take full advantage of the substantial and growing demand for biologics manufacturing,” said Roger Lias, PhD, President/CEO of Avid Bioservices. “With the divestiture of our lead R&D assets, our transition to a dedicated CDMO business is complete, and our team is entirely focused on expanding and diversifying our customer base, as well as strengthening our process development capabilities. At present, we are in late-stage negotiations with several potential new customers and expect to announce the executed agreements before the end of the fiscal year [4-30-18]. In recent weeks, we also completed a financing raising $23.2 million in gross proceeds. These funds are essential as they will support our operations, including upgrading our process development capabilities to ensure that we are fully capable of servicing our customers with the highest quality standards and equipment. We made rapid progress during the third quarter that we believe will allow us to build backlog and achieve sustainable growth in the future.”
RECENT CDMO DEVELOPMENTS
Advanced 8 current clients, some with multiple projects, through various stages of development.
Selected by Acumen Pharmaceuticals, Inc. to provide process development and clinical manufacturing services in support of ACU193, which is being developed for the treatment of Alzheimer’s disease.
° Avid and Acumen will immediately commence process development work with the goal of creating a robust, cost-effective and scalable process to support cGMP manufacture of ACU193.
RECENT CORPORATE DEVELOPMENTS AND FINANCIAL HIGHLIGHTS
Changed company name from Peregrine Pharmaceuticals, Inc. to Avid Bioservices, Inc.
° As the Avid name is recognized in the industry for CDMO excellence and biologics manufacturing expertise, the brand is an important asset in the company’s transition to a dedicated CDMO business. The company also adopted the new NASDAQ ticker symbol, "CDMO" (NASDAQ:CDMO).
Reconstituted board of directors including 6 independent directors, all with significant CDMO experience.
Entered into an Asset Assignment and Purchase Agreement with Oncologie, Inc. for Avid's phosphatidylserine (PS)-targeting program including bavituximab.
° Avid expects to receive an aggregate of $8.0 million in upfront payments over a period of 6 months and will be eligible to receive up to $95.0 million in development, regulatory and commercialization milestones.
° Oncologie, Inc. will be responsible for all future research, development and commercialization of bavituximab, and related intellectual property costs.
° Avid will receive royalties on net sales that are upward tiering into the mid-teens.
° Oncologie will enter into an agreement with Avid for future contract development and manufacturing activities in support of bavituximab.
Completed a public offering of 10,294,445 shares of common stock raising gross proceeds of approximately $23.2 million.
° Avid intends to use the net proceeds from the offering to support the growth of its contract manufacturing business and general corporate purposes.
The company maintains its manufacturing revenue guidance for the full FY 2018 of $50-55.0 million.
The current manufacturing revenue backlog has increased to $39 million.
Contract manufacturing revenue from Avid's clinical and commercial biomanufacturing services was $6.8 million for the third quarter of FY 2018 compared to $10.7 million for the third quarter of FY 2017. The decline was primarily due to lower demand from one of our largest customers.
Cost of contract manufacturing increased to $11.0 million in the third quarter of FY 2018 compared to $8.0 million for the third quarter of FY 2017. The current period increase in cost of manufacturing is primarily attributed to idle capacity costs of $5.3 million due to lower facility and personnel utilization compared to no idle capacity costs reported in the same prior year quarter.
Selling, general and administrative expenses for the third quarter of FY 2018 were $4.8 million, compared to $4.4 million for the third quarter of FY 2017. The current period increase in costs was primarily due to legal and other related fees associated with the settlement agreement with certain investors regarding the composition of the company’s board of directors and legal and advisory fees associated with the Asset Assignment and Purchase Agreement with Oncologie, Inc.
As of January 31, 2018, the company's research and development segment met all the conditions to be classified as a discontinued operation. Accordingly, the operating results of our research and development segment are reported as a loss from discontinued operations for all periods presented.
Avid's consolidated net loss attributable to common stockholders was $12.4 million or $0.28 per share, for the third quarter of FY 2018, compared to a net loss attributable to common stockholders of $9.2 million, or $0.25 per share, for the same prior year quarter.
Avid reported $17.9 million in cash and cash equivalents as of January 31, 2018, compared to $46.8 million at fiscal year ended April 30, 2017. Following the completion of a public offering during February 2018, the company had cash and cash equivalents of $41.7 million as of February 28, 2018.
More detailed financial information and analysis may be found in Avid’s Quarterly Report on Form 10-Q [ https://tinyurl.com/yd4orsg7 ], which will be filed with the SEC today.
CONFERENCE CALL
Avid will host a conference call and webcast this afternoon, March 12, 2018, at 4:30 PM EDT (1:30 PM PDT). To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Avid Bioservices conference call. To listen to the live webcast, or access the archived webcast, please visit: http://ir.avidbio.com/events.cfm .
ABOUT AVID BIOSERVICES, INC.
Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focused on development and cGMP manufacturing of biopharmaceutical products derived from mammalian cell culture. The company provides a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With nearly 25 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, please visit http://www.avidbio.com .
AVID BIOSERVICES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
Three Months Ended
January 31, Nine Months Ended
January 31, 2018 2017 2018 2017
Contract manufacturing revenue $ 6,819,000 $ 10,747,000 $ 46,678,000 $ 39,726,000
Cost of contract manufacturing 10,951,000 7,974,000 47,641,000 26,477,000
Gross profit (loss) (4,132,000 ) 2,773,000 (963,000 ) 13,249,000
Operating expenses:
Selling, general and administrative 4,824,000 4,365,000 12,273,000 13,602,000
Restructuring charges — — 1,258,000 —
Total operating expenses 4,824,000 4,365,000 13,531,000 13,602,000
Operating loss (8,956,000 ) (1,592,000 ) (14,494,000 ) (353,000 )
Other income (expense):
Interest and other income 42,000 25,000 83,000 71,000
Interest and other expense (14,000 ) (2,000 ) (18,000 ) (2,000 )
Loss from continuing operations $ (8,928,000 ) $ (1,569,000 ) $ (14,429,000 ) $ (284,000 )
Loss from discontinued operations (2,076,000 ) (6,205,000 ) (10,404,000 ) (22,603,000 )
Net loss $ (11,004,000 ) $ (7,774,000 ) $ (24,833,000 ) $ (22,887,000 )
Comprehensive loss $ (11,004,000 ) $ (7,774,000 ) $ (24,833,000 ) $ (22,887,000 )
Series E preferred stock accumulated dividends (1,442,000 ) (1,442,000 ) (3,604,000 ) (3,558,000 )
Net loss attributable to common stockholders $(12,446,000) $ (9,216,000) $(28,437,000) $(26,445,000)
Basic & diluted weighted average common shares outstanding(1):
45,225,804 37,258,794 45,032,335 35,486,782
Basic and diluted net loss per common share attributable to common stockholders (1):
Continuing operations $ (0.23 ) $ (0.08 ) $ (0.40 ) $ (0.11 )
Discontinued operations $ (0.05) $ (0.17 ) $ (0.23 ) $ (0.64 )
Net loss per share attributable to common stockholders $ (0.28) $ (0.25 ) $ (0.63 ) $ (0.75 )
(1) All share and per share amounts of our common stock for all prior fiscal year periods presented have been retroactively adjusted to reflect the one-for-seven reverse stock split of our issued and outstanding common stock, which took effect on July 10, 2017.
AVID BIOSERVICES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
January 31, 2018 April 30, 2017 Unaudited
ASSETS
Current assets:
Cash and cash equivalents $ 17,938,000 $ 46,799,000
Trade and other receivables 7,967,000 7,742,000
Inventories 14,218,000 33,099,000
Prepaid expenses 906,000 1,460,000
Total current assets 41,029,000 89,100,000
Property and equipment, net 26,325,000 26,515,000
Restricted cash 1,150,000 1,150,000
Other assets ,353,000 1,347,000
Total assets $ 69,857,000 $ 118,112,000
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 1,911,000 $ 5,779,000
Accrued clinical trial and related fees 5,503,000 4,558,000
Accrued payroll and related costs 3,876,000 6,084,000
Deferred revenue 6,633,000 28,500,000
Customer deposits 17,602,000 17,017,000
Other current liabilities 749,000 993,000
Total current liabilities 36,274,000 62,931,000
Deferred rent, less current portion 2,064,000 1,599,000
Commitments and contingencies
Stockholders’ equity:
Preferred stock—$0.001 par value; authorized 5,000,000 shares; 1,647,760 issued and outstanding at January 31, 2018 and April 30, 2017, respectively 2,000 2,000
Common stock—$0.001 par value; authorized 500,000,000 shares;
45,257,180 and 44,014,040 issued and outstanding at January 31, 2018 and April 30, 2017, respectively 45,000 44,000
Additional paid-in capital 593,621,000 590,971,000
Accumulated deficit (562,149,000) (537,435,000 )
Total stockholders’ equity 31,519,000 53,582,000
Total liabilities and stockholders’ equity $ 69,857,000 $ 118,112,000
Safe Harbor *snip*
CONTACTS:
• Stephanie Diaz (Investors) Vida Strategic Partners 415-675-7401 sdiaz@vidasp.com
• Tim Brons (Media) Vida Strategic Partners 415-675-7402 tbrons@vidasp.com
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From 10-Q header: “As of Mar. 7, 2018, there were 55,552,233 shares outstanding.”
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Latest 10K 4-30-17 iss. 7-14-17 http://tinyurl.com/ycxu4l5n PR: http://tinyurl.com/yb4wulvu (Cash 4-30-17=$46.8mm); Amended 8-25-17: http://tinyurl.com/yb5jq7vc
Latest 10Q 1-31-18 iss. 3-12-18 https://tinyurl.com/yd4orsg7 PR: http://ir.avidbio.com/releasedetail.cfm?ReleaseID=1060611 (Cash 1-31-18=$17.9mm; 2-28-18=$41.7mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
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Updated PPHM REVS-BY-QTR TABLE, now thru FY18'Q3(qe 1-31-18), per the 10-Q (https://tinyurl.com/yd4orsg7 ) issued 3-12-18.
• Total Avid Revs since May’03: $288.6mm
• 3-12-18: FY'18 (May'17-Apr'18) Avid revs guidance $50-55mm (committed B/L=$39mm at 1-31-18).
• Deferred-Revs at 1-31-18 total $6.6mm, DOWN from $7.5mm at 10-31-17.
• Cust.Deposits at 1-31-18 total $17.6mm, UP from $13.1mm at 10-31-17.
• Inventories at 1-31-18 total $14.2mm, DOWN from $16.5mm at 10-31-17.
• Avid’s Gross-Profit over last 4 qtrs: $5.2mm on revs of $64.6mm (GP%=8.0)
**1-31-18 10Q/p.6:
“Based on our current commitments for mfg. services from our 2 largest customers [HALO & ???], we expect our future results of operations to be adversely affected until we are able to further expand & diversify our customer base.”
Avid’s website: http://www.avidbio.com
AVID GROSS PROFITABILITY BY QTR: DEFER CUST
QTR (1000’s) Rev$ COGS$ Prof$ GP% REV$ INVEN$ DEP.
FY13Q1 7-31-12 4,135 2,024 2,111 51% 6,056 5,744 10,224
FY13Q2 10-31-12 6,061 3,703 2,358 39% 6,221 5,426 8,500
FY13Q3 1-31-13 6,961 3,651 3,310 47% 5,061 4,635 6,729
FY13Q4 4-30-13 4,176 3,217 959 23% 4,171 4,339 8,059
FY14Q1 7-31-13 4,581 2,670 1,911 42% 4,164 5,679 8,528
FY14Q2 10-31-13 7,354 4,195 3,159 43% 3,468 4,033 7,658
FY14Q3 1-31-14 3,885 2,416 1,469 38% 4,329 5,224 8,646
FY14Q4 4-30-14 6,474 3,829 2,645 41% 5,241 5,530 5,760
FY15Q1 7-31-14 5,496 3,583 1,913 35% 4,670 5,998 6,226
FY15Q2 10-31-14 6,263 4,139 2,124 34% 3,612 5,379 7,549
FY15Q3 1-31-15 5,677 3,113 2,564 45% 5,752 6,148 8,311
FY15Q4 4-30-15 9,308 4,758 4,550 49% 6,630 7,354 11,363
FY16Q1 7-31-15 9,379 4,608 4,771 51% 8,291 10,457 9,599
FY16Q2 10-31-15 9,523 4,741 4,782 50% 9,688 12,554 14,935
FY16Q3 1-31-16 6,672 3,896 2,776 42% 15,418 15,189 22,433
FY16Q4 4-30-16 18,783 9,721 9,062 48% 15,418 15,189 24,212
FY17Q1 7-31-16 5,609 3,062 2,547 45% 21,531 25,274 21,731
FY17Q2 10-31-16 23,370 15,441 7,929 34% 17,980 25,924 26,928
FY17Q3 1-31-17 10,747 7,974 2,773 26% 26,367 33,829 26,210
FY17Q4 4-30-17 17,904 11,782 6,122 34% 28,500 33,099 17,017
FY18Q1 7-31-17 27,077 20,448 6,629 24% 13,433 24,235 14,322
FY18Q2 10-31-17 12,782 16,242 -3,460 -27% 7,473 16,518 13,138
FY18Q3 1-31-18 6,819 10,951 -4,132 -61% 6,633 14,218 17,602
FY13 TOTAL: 21,333 12,595 8,738 41%*
FY14 TOTAL: 22,294 13,110 9,184 41%*
FY15 TOTAL: 26,744 15,393 11,151 42%*
FY16 TOTAL: 44,357 22,966 21,391 48%*
FY17 TOTAL: 57,630 38,259 19,371 34%*
FY18 YTD(Q1+2+3) 46,678 47,641 -963 -2%*
*Avid Net-Profit(Selling/G&A) not split out from PPHM-Corp. in the fin’s.
AVID TOTAL REV’s BY YEAR):
FY04 4-30-04 3,039 (Avid-Revs didn’t incl. Avid’s Gov’t work)
FY05 4-30-05 4,684
FY06 4-30-06 3,005
FY07 4-30-07 3,492
FY08 4-30-08 5,897
FY09 4-30-09 12,963
FY10 4-30-10 13,204
FY11 4-30-11 8,502
FY12 4-30-12 14,783
FY13 4-30-13 21,333
FY14 4-30-14 22,294
FY15 4-30-15 26,744
FY16 4-30-16 44,357
FY17 4-30-17 57,630
YTD 4-30-18 46,678 (thru 3 qtrs)
**TOTAL: 288,605 (5/1/2003–1/31/18)
.
QTLY. NET LOSS BY QTR:
(“attributable to common stockholders”; ie, incl. PREF Div’s**)
**2-11-14: PPHM Raises $16.2M, 700k Pref. Shares w/10.5% DIV.
FY16Q1 7-31-15 15,101,000
FY16Q2 10-31-15 14,578,000
FY16Q3 1-31-16 18,227,000
FY16Q4 4-30-16 13,264,000
FY17Q1 7-31-16 12,437,000
FY17Q2 10-31-16 4,498,000
FY17Q3 1-31-17 9,216,000
FY17Q4 4-30-17 6,714,000
FY18Q1 7-31-17 2,647,000
FY18Q2 10-31-17 14,066,000
FY18Q3 1-31-18 12,446,000
Period Halozyme Cust-A Other-Custs
FYE 4-30-14 91% 1% 8%
FYE 4-30-15 79% 12% 9%
FYE 4-30-16 69% 26% 5%
Q/E 7-31-16 65% 29% 6%
Q/E 10-31-16 77% 10% 13%
Q/E 1-31-17 29% 56% 15%
FYE 4-30-17 58% 26% 16%
Q/E 7-31-17 78% 16% 16%
Q/E 10-31-17 Cust%’s section not in this 10-Q.
Q/E 1-31-18 Cust%’s section not in this 10-Q.
Oncologie’s Laura Benjamin speaking at GRC/Lymphatics Conf. Mar12-13
3-12-18 3-4pm: The GRC Power Hour is an opt. informal gathering open to all meeting participants. It is designed to help address the challenges women face in science and support the professional growth of women in our communities by providing an open forum for discussion & mentoring. Organizer: LAURA BENJAMIN (Oncologie, Inc., USA)
3-13-18 12:10-12:25pm: "Drug Discovery" LAURA BENJAMIN (Oncologie, Inc., USA)
Mar11-16 2018: Gordon Research Conference, “Lymphatics” (Barga IT)
Insights into Lymphatic System Biology, Pathology and Organ-Specific Role in Health and Disease https://www.grc.org/lymphatics-conference/2018/
= = = = = =
2-12-18: Peregrine’s Legacy PS-Targeting IP Sold to ONCOLOGIE INC. (Boston, CEO: Laura E. Benjamin) for $8M/upfront, $95M/milestones https://tinyurl.com/yam8gb3h
New EVENT added: Mar13 2-2:30pm ROTH/RogerLias/Webcast
http://ir.avidbio.com/events.cfm
UPCOMING EVENTS:
Mar6: Merck Single-Use Symposium, East Norriton, PA https://events.planetconnect.com/merck-single-use/
…Tracy Kinjerski(VP/BusOP) will present on Avid's Flexible & Efficient Mfg. Solutions.
Mar13/Roger Lias: 30th Annual Roth Conf., Laguna Niguel http://www.roth.com/main/page.aspx?PageID=7290
...2-2:30PT: Corp. presentation, Webcast (wsw.com): https://tinyurl.com/y9keay3u
Mar19-22/Booth415: BioProcess Intl. West Conf., SanFran http://ir.avidbio.com/events.cfm
Mar19-22: DCAT Week, NYC http://ir.avidbio.com/events.cfm DCAT=Drug, Chem, and Associated Tech. Assoc.
Jun4-7/Booth1073: BIO Intl. Convention, Boston http://ir.avidbio.com/events.cfm
~Jul13: FY'18Q4 (qe 4-30-18) Financials & Conf. Call
Aug13-17/Booth310: The Bioprocessing Summit, Boston http://ir.avidbio.com/events.cfm
Sep4-7: BioProcess Intl. Conf. & Exhibition, Boston http://ir.avidbio.com/events.cfm
~Sep10: FY'19Q1 (qe 7-31-18) Financials & Conf. Call
~Oct11: Avid's 2018 Annual Shareholder’s Meeting, Tustin CA
“...we expect will be several near-term client wins...”. We’ve argued over the years as to what “several” means, but I think it’s 3 or more. I don’t think 2 qualifies as “several”.
“This agreement with Acumen is the latest of what we expect will be several near-term client wins arising from our dedicated efforts to expand and diversify our customer base. The opportunity to work with Acumen and support the important work they are undertaking in the field of Alzheimer’s disease is gratifying for the entire Avid team,” said Roger Lias, Pres./CEO of Avid Bioservices. “We look forward to delivering exceptional results to Acumen based on our proven ability to work efficiently and creatively to support the rapid advancement of novel therapeutics through process development and into cGMP clinical manufacturing.”
3-1-18: “Avid Bioservices Selected by Acumen Pharm. to Lead Process Dev. & Clinical Mfg. of Novel Alzheimer's Disease Candidate [ACU193]”
http://ir.avidbio.com/releasedetail.cfm?ReleaseID=1059286
Geo, :re NET SALES - you’ve said that a couple of times now with disgust. I truly believe you’re confusing NET SALES with NET PROFIT. Nothing wrong with basing milestone payments on NET SALES - it’s the norm.
“NET SALES are the amount of SALES generated by a company after the deduction of returns, allowances for damaged or missing goods and any discounts allowed…
The SALES NUMBER reported on a company's financial statements is a NET SALES number, reflecting these deductions.”
Sept.2017: The Pharmaceutical CDMO Industry Is Consolidating - Opportunities For Current Players And New Entrants
PDF (16pgs): https://tinyurl.com/yd843qan <=link works after converting via TINY. ???
“The CDMO market is complex – there are lots of options for small & big players to position themselves.”
PG.3:
“These 2 deals are remarkable in size and represent the largest premiums paid for CDMOs in more than 5 years: Thermo Fisher Scientific’s US$7.2b [May’17] offer values Patheon at 16x to 17x its expected 2017 EBITDA, in line with Capsugel’s [Dec’16] 16x multiple. Yet they constitute only the tip of the iceberg of the rising M&A activity in the CDMO industry… Given the continual need for outsourced manufacturing and the still fragmented vendor landscape, the CDMO industry is expected to remain a very attractive sector for M&A activity in the future.”
About EY:
EY is a global leader in assurance, tax, transaction and advisory services… EY refers to the global organization, and may refer to one or more, of the member firms of Ernst & Young Global Ltd… http://ey.com
2-23-18: CFO Paul Lytle voluntarily resigns, eff. 5-24-18 (2-23-18 +90days)
https://tinyurl.com/ycgy8g9p (8-K)
On 2-23-18, Paul J. Lytle gave notice of his voluntary resignation as CFO of Avid Bioservices, to be effective 90 days from the date of the notice [5-24-18], or the Extended Notice Period. Pursuant to Sect7.5 of his 12-27-12 Amended & Restated Emp. Agreement, the Company shall continue to pay Mr. Lytle his monthly base salary and provide his Company-paid medical benefits during the Extended Notice Period and for a period of 6mos. following the expiration of the Extended Notice Period; provided, that Mr. Lytle makes himself telephonically available to the Company’s BOD’s & Exec. Team for up to 2hrs/week during such 6mo. period.
The Company is initiating a search for its next CFO.
2-26-18/PR: https://tinyurl.com/y8qn5ark
...on Feb. 23, 2018, Paul J. Lytle notified the company of his intent to resign his position as CFO, effective May 24, 2018, to spend more time with his family prior to returning to work in the drug dev. sector. A search for Mr. Lytle's replacement has been initiated, and Mr. Lytle will support the transition.
"Paul has been a principal member of mgt. for over 20 years, and his leadership was critical in the founding of the company's contract dev. & mfg. business in 2002," said Roger Lias, PhD, Pres./CEO of Avid Bioservices. "We are grateful for Paul's many contributions to Avid and we wish him well in his future endeavors."
AVID TEAM: https://avidbio.com/team/
AVID OPENINGS: https://avidbio.applicantpro.com/jobs/
2 New EVENTS: R.Lias/Today/NYC; T.Kinjerski/Mar6/Merck-Symposium
http://ir.avidbio.com/events.cfm
2-22-18: 2018 RBC Capital Markets Global Healthcare Conf., NYC
...Roger J. Lias will deliver a corporate presentation.
(I don’t see a time, nor any info on a webcast)
3-6-18: Merck Single-Use Symposium, East Norriton, PA
...Tracy Kinjerski (Avid's VP/Bus.OP) will give a presentation on Avid's Flexible & Efficient Manufacturing Solutions.
https://events.planetconnect.com/merck-single-use
KNOWN UPCOMING EVENTS
Feb22: RBC Capital Markets Global HC/Conf., NYC (R.Lias, Corp. Presentation)
Mar6: Merck Single-Use Symposium, East Norriton, PA
…Tracy Kinjerski(VP/BusOP) will present on Avid's Flexible & Efficient Mfg. Solutions.
~Mar12: FY'18Q3 (qe 1-31-18) Financials & Conf. Call
Mar19-22/Booth415: BioProcess Intl. West Conf., SanFran http://ir.avidbio.com/events.cfm
Mar19-22: DCAT Week, NYC http://ir.avidbio.com/events.cfm
Jun4-7/Booth1073: BIO Intl. Convention, Boston http://ir.avidbio.com/events.cfm
~Jul13: FY'18Q4 (qe 4-30-18) Financials & Conf. Call
Aug13-17/Booth310: The Bioprocessing Summit, Boston http://ir.avidbio.com/events.cfm
Sep4-7: BioProcess Intl. Conf. & Exhibition, Boston http://ir.avidbio.com/events.cfm
~Jul10: FY'19Q1 (qe 7-31-18) Financials & Conf. Call
PW, “SWIM Partners LP” is Stephen White’s. I’ve never seen anything that shows Jamie Egan, Saiid Zarrabian, or Brian Scanlan (3 orig. Ronin BOD nominees that didn’t end up on Avid’s BOD), or the 3 Ronin/SW Nominees that did end up on Avid’s BOD (Richard Hancock, Gregory Sargen, Joel McComb), are in any way related to/involved with SWIM Partners.
If you find anything, let me know.
SWIM PARTNERS:
https://www.sec.gov/Archives/edgar/data/1556907/000155690717000004/xslFormDX01/primary_doc.xml
Members of the original Ronin/SWIM SEC “13D Group”:
“...filed on behalf of John S. Stafford, III, Ronin Trading, LLC, Roger Farley, Stephen White, SW Investment Management LLC, SWIM Partners LP, James J. Egan, Richard B. Hancock, Joel McComb, Gregory P. Sargen, Brian W. Scanlan and Saiid Zarrabian...”
2-20-18 13D (Amend #10): https://tinyurl.com/ych9aspz
...Again, those orig. Ronin BOD nominees (Jamie Egan, Saiid Zarrabian, Brian Scanlan) that didn’t end up on Avid’s BOD are ALL showing ZERO SHARES owned, and DID NOT buy any shares via the 10M public offering yesterday. If they had done so, they would have to show it in the 13D yesterday.
2-20-18: LARGE OWNERSHIP SUMMARY – AVID “CDMO”
This update:
1. Common O/S shares 45,253,038=>55,547,483 after 2-20-18 Direct Placement 10,294,445@$2.25 (underwriter: Wells Fargo).
2. Ronin/SW Group adds +1,302,000sh. Feb9-Feb15; total beneficial now 5,194,487=9.4%.
3. BOD member direct purchases:
...a. Joel McComb pur. 50,000@$2.25 on 2-15-18. (Form 4)
...b. Mark Bamforth pur. 50,000@$2.25 on 2-15-18. (Form 4)
...c. Joseph Carleone(chair) pur. 44,445@$2.25 on 2-15-18. (Form 4)
SEE: 2-20-18/13D: https://tinyurl.com/ych9aspz & Form 4’s: https://tinyurl.com/yc4zjyzv
= = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
2-20-18: Large Ownership Summary(35.0%) - now 19,439,539shs. (O/S at 2-20-18: 55,547,483)
(Ronin+SW/Stafford+Farley+White, Eastern Cap./K.Dart, Institutions incl. Tappan’s 2-14-18/13G)
3 LARGEST SHAREHOLDERS:
#1: 2-20-18/13D: Group Ronin Trading/SWInvest (John Stafford III+R.Farley+Stephen White) now has 9.4% stake (5,194,487sh.) in PPHM
...5,042,000 COMMON – 9.1% of 55,547,483 common O/S at 2-20-18 (total beneficial=5,194,487 if Pref. conv. x1.1905 to Common)
...128,099 PREFERRED – 7.8% of 1,647,760 preferred O/S at 11-27-17
#2: 2-14-18/13G: Tappan St. Partners (Prasad Phatak) owns 4,516,107sh. (8.1% of 55,547,483 common O/S at 2-20-18) - see INST.OWNERSHIP below.
#3: 12-7-17: Kenneth Dart (Eastern Capital) acquires 7.7% stake (4,300,992sh.) in PPHM in 10-2015 https://tinyurl.com/y7qprpg9
...3,777,183 COMMON – 6.8% of 55,547,483 common O/S at 2-20-18 (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 11-27-17
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
10-27-17 10/17/17-10/27/17 +190,427 0 4,173,391 128,099 http://tinyurl.com/y7hslequ (14A)
2-8-18 1/22/18-2/6/18 -433,391 0 3,740,000 128,099 https://tinyurl.com/ya43sc3r
2-20-18 2/9/18-2/15/18 +1,302,000 0 5,042,000 128,099 https://tinyurl.com/ych9aspz
SPLITOUT 13D GROUP into Ronin(John Stafford III, R.Farley) & SW-Partners(Stephen White):
Ronin Trading (Stafford) 4,040,000 115,299 (beneficial=4,177,260)
Ronin’s Roger Farley 275,000 1,000 (beneficial=276,190)
SW-Partners (White) 727,000 11,800 (beneficial=741,047)
- - - - - - - - - - - - - - -
Plus, INSTITUTIONS a/o 12-31-17: 9,944,060sh. = 17.9%
...Adj. for Tappan still @9-30-17 on Nasdaq: 8,298,953 – 2,871,000 +4,516,107 = 9,944,060
http://www.nasdaq.com/symbol/cdmo/institutional-holdings
TOP10: (with qtly chgs. Since 9-30-17):
Tappan St. Partners 4,516,107 +1,645,107 <=per 2-14-18/13G(see below)
Vanguard Group 1,442,656 -75,454
Blackrock (Larry Fink) 762,010 +708
Bandera Partners 613,037 +58,037
Renaissance Tech. 549,106 +1,916
Geode Capital Mgt. 451,352 +225,676
Wells Fargo & Co. 195,904 +78,075
Stifel Financial 195,102 -9,203
Eqis Capital Mgt. 148,176 +4,581
Quinn Opportunity 92,000 NEW
**2-14-18/13G: Tappan St.(Prasad Phatak) https://tinyurl.com/yd7xkdzg (Event date: 12-31-17)
2 Funds + P.Phatak’s personal shares:
...Partners LLC, Tappan St. Fund L.P. 1,540,000
...Tappan St. Partners Ideas Fund L.P. 2,890,000
...Prasad Phatak (Principle Owner) 86,107
Total TAPPAN: 4,516,107 (10.0%)
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 7-11-17)
a/o 9-30-17: 2,871,000 6.4% (of 45,096,081 O/S 9-11-17)
a/o 11-6-17: 3,915,611 8.7% (of 45,096,081 O/S 9-11-17)
a/o 12-31-17: 4,516,107 10.0% (of 45,253,038 O/S 1-8-18)
Final Qtly Inst. Holdings from Nasdaq:
3-31-17: 5,690,888
6-30-17: 6,834,425
9-30-17: 8,491,679
12-31-17: 9,944,060 (adj. For Tappan 2-14-18/13G)
2-12-18: Avid Sold its “PS-Targeting pgm/incl. Bavi; other PS-targeting antibodies/incl. Betabodies; and certain other assets & licenses useful and/or necessary for the potential commercialization of Bavi” to Oncologie. https://tinyurl.com/yam8gb3h
The area that clearly was NOT SOLD to Oncologie was:
TUMOR NECROSIS THERAPY (TNT/COTARA/VEA's)
….This defunct 1998-2012 pgm. archived to: http://tinyurl.com/yc4ye6m4
To me, that’s the main difference between ALL and BULK OF.
2-20-18: Outsourcing-Pharma Quotes CEO Roger Lias
2-20-18/Outsourcing-Pharma: “Avid Raises $20M, Working ‘Aggressively’ To Grow CDMO Business”
- Avid Bioservices expects new contractual commitments in the coming weeks & months after raising more than $20M and completing its transition to a dedicated CDMO, says CEO.
By: Melissa Fassbender
https://www.outsourcing-pharma.com/Article/2018/02/20/Avid-raises-20m-working-aggressively-to-grow-CDMO-business
As Outsourcing-Pharma. previously reported, the now-defunct Peregrine Pharmaceuticals began selling off its R&D assets to focus on its CDMO subsidiary Avid Bioservices late last year. In the past week, the company has completed its transition to a dedicated CDMO by divesting the bulk of its legacy R&D assets, Roger Lias, PhD, Pres./CEO of Avid Bioservices told us. Subsequently, Avid has completed a follow-on offering, which raised more than $20M.
”The funds will be used to expand the contract mfg. business and general corporate purposes, Lias explained. This will include the expansion of our process dev. capabilities, as well specific capital improvements to mfg. infrastructure designed to enhance operational efficiency. Now, as a fully focused CDMO, we are working aggressively to grow our business by both increasing our backlog of business and converting revenue from both legacy and new customers.”
Lias explained the company is also dedicating resources to strengthen its early phase service offering for high-throughput development, ”rapidly progressing projects into manufacturing, and efficiently on-boarding new client programs”.
Since establishing itself as a dedicated CDMO, Lias said Avid has received ”very favorable feedback from a number of audiences, including a positive reaction from Wall Street, as well as a rapid acceleration of momentum related to business development. To this end, we expect to announce a number of new contractual commitments in the coming weeks and months”, he added.
*END*
= = = = = = = = = = = = = = = = =
DEC. 2017 Company Update - "Peregrine is Transitioning to a Pure-Play CDMO, Avid Bioservices, Inc."
...FULL HISTORY of 2017 PPHM-Ronin PR’s, Letters, 13-D’s, Form4’s, Proxy’s, etc: https://tinyurl.com/ybqvzwhg
12-11-17 10-Q for q/e 10-31-17:
Business Description – Peregrine is a company committed to improving the lives of patients by manufacturing pharmaceutical products through our CDMO, Avid Bioservices, Inc.
"Over the next 60 days, we plan to complete the transition from a R&D company to a dedicated CDMO company focused on dev. & mfg. of biopharmaceutical products derived from mammalian cell culture.
We plan to take ADDL. STEPS steps over the near term, including but not limited to:
1. Rebranding the company as Avid Bioservices, Inc.
2. Changing our ticker symbol on the NASDAQ Capital Market to align with our rebranding efforts
3. Broadening our sales force
4. Increasing our marketing efforts to support our rebranding & vision
5. Completing the wind down of all R&D activities and the potential licensing/divestiture of our assets related to our R&D operations.”
12-26-17: Roger Lias replaces Steven King as Pres./CEO; in process of changing name to Avid Bio. and new Nasdaq Ticker https://tinyurl.com/yb34e2t8
1-8-18: Name chg. to Avid Bioservices, Inc. (from Peregrine Pharm.) & NASDAQ Ticker chg. to "CMDO" (Preferred: CDMOP) https://tinyurl.com/y8vhjow4
1-8-18/Roger Lias: EBD's Biotech Showcase 2018 (parallel w/JPM Conf.), SanFran - Slideshow: https://tinyurl.com/ya6tgxxa
1-12-18: S-3 Shelf Registration filed for up to $125mm https://tinyurl.com/y9qtewpw
......2-15-18: Avid Raises $19,035,000 net, selling 9M shares @$2.25 (underwriter: Wells Fargo) https://tinyurl.com/ycpshgxl (424B5)
1-18-18: Avid's 2017 Annual Shareholders Mtg (@Myford Facilty) => Roger Lias' Slideshow & Attendee Reports https://tinyurl.com/yca6enbr
1-29-18/Roger Lias: NobleCon14 - Noble's 14th Annual Inv. Conf., Ft.Laud. => Webcast/Slideshow https://tinyurl.com/yanwk9yo
2-12-18: Peregrine’s Legacy PS-Targeting IP Sold to ONCOLOGIE INC. (Boston, CEO: Laura E. Benjamin) for $8M/upfront, $95M/milestones https://tinyurl.com/yam8gb3h
ARCHIVE of Peregrine’s Anti-PS/Bavituximab Platform - MOA, Trials, and Activity over the years, from mid-2000’s thru 2017, culminating with its 2-12-18 Sale to Oncologie Inc. for $8M/upfront, $95MM/milestones https://tinyurl.com/yam8gb3h
Peregrine Pharmaceuticals, Inc. (PPHM), Tustin CA. http://www.peregrineinc.com is committed to improving the lives of patients by delivering high quality pharmaceutical products through its contract development & mfg. organization (CDMO) services and through advancing and licensing its investigational immunotherapy and related products. Peregrine's in-house CDMO services, including cGMP mfg. & dev. capabilities, are provided through its wholly-owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com ), which provides development & biomfg. services for both Peregrine & 3rd-party customers. The company is also working to evaluate its lead immunotherapy candidate, BAVITUXIMAB, in combination with immune stimulating therapies for the treatment of various cancers, and developing its PROPRIETARY EXOSOME TECHNOLOGY for the detection & monitoring of cancer using assays that are able to detect small amts of PS+ Exosomes in a patient's blood sample. Bavituximab, a phosphatidylserine(PS)-targeting antibody, represents a new approach to treating cancer. Bavituximab was invented by UTSW's Dr. Philip Thorpe (1951-2013), and research continues in Dr. Rolf Brekken's UTSW lab.
DEC. 2017 Company Update - "Transitioning to a Pure-Play CDMO, Avid Bioservices, Inc."
12-11-17 10-Q for q/e 10-31-17: https://tinyurl.com/y75kwojs
Business Description – We are a company committed to improving the lives of patients by manufacturing pharmaceutical products through our CDMO, Avid Bioservices, Inc.
"Over the next 60 days, we plan to complete the transition from a R&D company to a dedicated CDMO company focused on dev. & mfg. of biopharmaceutical products derived from mammalian cell culture.
We plan to take ADDL. STEPS steps over the near term, including but not limited to:
1. Rebranding the company as Avid Bioservices, Inc.
2. Changing our ticker symbol on the NASDAQ Capital Market to align with our rebranding efforts
3. Broadening our sales force
4. Increasing our marketing efforts to support our rebranding & vision
5. Completing the wind down of all R&D activities and the potential licensing/divestiture of our assets related to our R&D operations.”
12-26-17: Roger Lias replaces Steven King as Pres./CEO; in process of changing name to Avid Bio. and new Nasdaq Ticker https://tinyurl.com/yb34e2t8
1-8-18: Name chgs. to Avid Bioservices, Inc. (from Peregrine Pharm.) and NASDAQ Ticker chgs. to "CMDO" (Preferred: CDMOP) https://tinyurl.com/y8vhjow4
1-18-18: Avid's 2017 Annual Shareholders Mtg (@Myford Facilty) => Roger Lias' Slideshow & Attendee Reports https://tinyurl.com/yca6enbr
1-29-18/Roger Lias: NobleCon14 - 14th Annual Inv. Conf., Ft.Laud. => Webcast/Slideshow https://tinyurl.com/yanwk9yo
2-12-18: Peregrine’s Legacy PS-Targeting IP Sold to ONCOLOGIE INC. (Boston, CEO: Laura E. Benjamin) for $8M/upfront, $95M/milestones https://tinyurl.com/yam8gb3h
• BAVI MOA: By blocking the immunosuppressive signal of exposed PS, Bavi mediates multiple immunostimulatory changes in the tumor environment, including a reduction of tumor-promoting immune cells and an increase in tumor fighting (M1) macrophages, dendritic cells, and cytotoxic T-cells (CD8+ CD45+ CD3+) that fight solid tumors. (see: AACR'15 & ASCO'15 & ImVacS’15 & SITC'15 & S.King/1-18-16 & AACR'16 & AACR'17 & ASCO'17)
• COLLABS: In addition to the ongoing UTSW/Brekken/Schroit research collab., 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”, then w/AstraZeneca in Aug'15(see PR) to run human trials evaluating Bavi+Durvalumab(Imfinzi) in "mult-solid-tumor-types", and w/The Natl. Comprehensive Cancer Network (NCCN) in Jan'16 via a $2M res. grant to NCCN which will “significantly expand Peregrine's clinical evaluation of bavituximab” at “27 of the world's leading cancer centers” (9-16-16: NCCN selects 3 Bavi Trials to in 2017 at Moffitt/MassGen/JohnsHopkins). Also, w/Duke Univ. (See Dr. Herbert K. Lyerly: AACR-IO/10-22-16), MD Anderson (See Dr. Jason Fleming), Rutgers Univ. (See Dr. Raymond Birge), and ImmunoVaccine Inc. (AACR'17 4-4-17 #3657). MORE on PreClin. Collabs: http://tinyurl.com/heg9t3v
• AVID: Peregrine also operates Avid Bioservices, a wholly owned cGMP CMO subsidiary, which provides contract mfg. services on a fee-for-service basis (revs. May'06-Oct17=$271.1mm), as well as support of Peregrine's own product pipeline. 5-2017: Avid II(Myford) expands; total Avid mfg. capacity now > 11,000L - see http://tinyurl.com/ky7bmu4
4-2-13: Peregrine Mourns Loss of Dr. Philip E. Thorpe (1951-2013) http://tinyurl.com/l9gqmt5
”Phil will be sorely missed as a colleague and friend. At Peregrine, each of us is pursuing Phil's dream of bringing important drugs to patients who need them based on his basic research. We are more motivated than ever to see this dream through."
…Dr. Thorpe’s successor at UTSW: long-time colleague, co-inventor of 2C3, Dr. Rolf A. Brekken, PhD - http://www.utsouthwestern.edu/labs/brekken
8-2014: UK colleagues from Chester Beatty Labs(ICR/Univ-London), ICRF(IsraelCancerRes), & UTSW create memorial for Dr.Thorpe in London’s Chelsea Physic Garden: http://tinyurl.com/lon73l7
Yahoo Quote & Profile for PPHM: Yahoo.com/PPHM ...Nasdaq Quote: http://www.nasdaq.com/symbol/pphm ...PPHM Tweets: http://stocktwits.com/symbol/PPHM
• IR: info@peregrineinc.com: Stephanie Diaz (Investors) Vida Strategic Partners 415-675-7401 sdiaz@vidasp.com, Tim Brons (Media) 415-675-7402 tbrons@vidasp.com
• PPHM's 7-13-17 Ronin PR had: MEDIA CONTACTS - John Christiansen / Matt Reid, Sard Verbinnen & Co., 415-618-8750 / 310-201-2040 http://www.sardverb.com
SCIENCE: "Evolution has favored pathogenesis that resembles apoptosis."
Dr. Judah Folkman: ”This [Thorpe’s VTA research] is very promising and very elegant work... The whole goal is really 2-part, reducing the harsh side effects of cancer treatment, and reducing the chance that some cancer cells will evade treatment. That would be a big step in the next decade, and anti-vascular therapy will play a major role." (’97 & ’02 http://tinyurl.com/k5qe96g & http://tinyurl.com/n6vh9hp )
Bavituximab MOA & Clinical Data: http://www.peregrineinc.com/pipeline/bavituximab-oncology.html
...Bavi Publications: http://www.peregrineinc.com/publications/publications.html
...Bavi Posters & Presentations: http://www.peregrineinc.com/publications/posters-and-presentations.html
Bavi MOA: Video (3:34) added ~3-2014 https://vimeo.com/87116642 "Bavituximab: A Novel Immunotherapy Candidate Targeting an Upstream Immune Checkpoint to Fight Cancer"
Bavi MOA: Video (1:33) on Bavi’s Immunotherapeutic MOA added to Youtube on 3-27-14 https://www.youtube.com/watch?v=Esewl35JD8s
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Expert Quotes/Commentary On Bavituximab's Moa/Potential: http://tinyurl.com/nmdw4
Peregrine's Patent Estate - excl. licenses from UTSW MDA U-CALIF USC: http://tinyurl.com/58cn74
7-16-12 Form 10-K (fy/e 4-30-12): License Agreements between PPHM & UTSW/DNA/Avanir/Lonza (pg.10) http://tinyurl.com/agy6hn6
…Royalty %'s payable to UTSW/Dallas on sales of future-approved Anti-PS drugs will be in the "low single digits"
4-2006: Tarvacin (chimeric 3G4) will henceforth be referred to by its generic name, BAVITUXIMAB, to avoid confusion with OSI's anti-cancer drug Tarceva. http://tinyurl.com/2vawjv
1-23-18/Dovepress: “Antibody Targeting of PS for the Detection & Immunotherapy of Cancer” https://tinyurl.com/ybertbjo
...Joint UTSW+PPHM - gives a history of PS-Targeting (Bavituximab), both pre-clin. studies & human trials to date. For SUNRISE, for Results (Table 3), it says, “Manuscript in preparation”
10-1-17/JrnlRadONCO: “ChemoRad.+PSTargeting Enhances Anti-tumor Immune Responses (Mice)” (MDA+PPHM) https://tinyurl.com/yd7lrr8x
BAVI MOA 4-3-17 AACR'17: Joint Memorial Sloan Kettering (Wolchok Lab) & PPHM poster: “PS Targeting+Adoptive TCell Transfer (ACT) Eliminates Adv. Tumors w/o Off-Target Toxicities, Melanoma” http://tinyurl.com/lxlltd6
BAVI MOA 1-30-17 Mol.Cancer article: MDA/J.Fleming, UTSW/Brekken, “PreClin. Eval of DNAtrix's DNX2401+BAVI for Pancreatic Cancer” http://tinyurl.com/hb6m3yj
...Combo DNAtrix's DNX-2401(Oncolytic Virus) + BAVI “significantly inhibited tumor growth; further enhanced its anticancer activity; warrants further clinical evaluation...”
BAVI MOA 11-14-16 SITC’16: Joint Memorial Sloan Kettering (Wolchok Lab) & PPHM poster on Triple Combo Rad+Bavi+aPD1 vs. Melanoma http://tinyurl.com/js3fca4
...Dr. Jedd Wolchok states, “Based on these study results, we believe that the targeting of PS is having meaningful activity within the tumor microenvironment in the B16 melanoma model. It appears that this activity creates a more immune active environment in which other treatments, including radiation, are able to have a greater anti-tumor impact." => AACR'17 Update 4-2-17 (#574) http://tinyurl.com/m7868sx
BAVI MOA 10-22-16: Duke’s Herbert K. Lyerly (w/PPHM) poster on AntiPS/TNBC data at AACR’s Tumor Immunotherapy Conf./Boston http://tinyurl.com/zzryfok
...”Modulating The Tumor Microenvironment to Enhance Cancer Immunotherapy by Inducing Phosphatidylserine Expression on the Tumor Surface”
BAVI MOA 9-27-16 AACR-CRI/Dr. Michael Gray: Preclin. Triple-Combo Bavi+PD1+LAG3 TNBC data in TNBC (80% Compl. Regression, Stat-Sig. Incr. in Key Tumor Fighting Immune Cells) http://tinyurl.com/zy9yv78
BAVI MOA 7-27-16 Shaul/Brekken/Thorpe/etal PLOS ONE article: Fhu/Bavi vs. APS-related Pregnancy Complications & Thrombosis http://tinyurl.com/jlhrdg2
...”The potential clinical impact of 1N11 (Fhu Bavi) in patients with APS is substantial. Spring-boarding from the present discovery of 1N11 as a highly-effective, mechanism-based treatment for APS in a comprehensive series of mouse models of APS-related disorders, clinical studies of 1N11 now warrant consideration.”
BAVI MOA 5-11-16 Breast Cancer Res. article, B.Freimark/M.Gray/CW.Hughes-et-al, “PS-Targeting/Bavi Combo w/Anti-PD1/PDL1 in Triple.Neg-MBC” http://tinyurl.com/zxu882y
...”our observations demonstrate that including PS-targeting antibodies such as bavituximab can enhance the anti-tumor activity of anti-PD-1/PD-L1 treatments, not only by increasing TIL responses but also by inhibiting cytokines stimulated by single-agent anti-PD-1 therapy that serve to suppress the immune response & promote tumor progression.”
BAVI MOA 4-20-16/AACR'16 & 4-4-16/Cancer-Immunology-Res.(AACR) article - preclin. data: Bavi combo w/anti-PD-1/anti-CTLA-4 “induces a shift in tumor microenvironment from immunosuppressive to immune active” http://tinyurl.com/jyox458
BAVI MOA 1-18-16: CEO Steve King explains PPHM's direct PS-Targeting advantage vs. the “individual-receptors” PS-binding approach of others like: Axl Mer TIM-3 RAGE Tyro3 GAS6 CD300a BAI1 MFG-E8 etc. http://tinyurl.com/h2h87mc
2-2016: Rutgers' Dr. Raymond Birge's relationship with Peregrine & UTSW's Dr. Rolf Brekken and his 2-26-16 article, “Phosphatidylserine is a Global Immunosuppressive Signal in Efferocytosis, Infectious Disease, and Cancer” http://tinyurl.com/z5d9qt9 and 9-26-16 AACR/CRI, “Characterization of a PS, TAM Receptor (Tyro3, Axl, Mertk), PDL1 Axis in Breast Cancer” http://tinyurl.com/ldlzka8
11-9-15 SITC'15: New Bavi+Checkpoint Inhibitors preclin. data (DUKE's Herbert K. Lyerly + PPHM + UTSW) http://tinyurl.com/pbof95w
...Also, collab. with Dr. Bernard Fox (Immunotherapist/Earle A. Chiles Res.Inst.) on new Immuno-Profiling Clinical Test (Opal 6-plex quantitative IF Assay), PPHM roundtable with Raymond Birge (Rutgers), Douglas Graham (Emory), Dmitry Gabrilovich (Wistar), Rolf Brekken (UTSW), Maria Karasarides (AstraZeneca) - ”Combining Bavi w/anti-PD-1 significantly enhanced O/S… significant incr. CD45+, CD8+ and CD3+ T-cells… led a prolonged anti-tumor immune response which protected the animals against a re-challenge w/same tumor.”
BAVI MOA 8-26-15: Jeff Hutchins(VP/PreClin-Res) ImVacS’15 Talk – 29pg. Slideshow http://tinyurl.com/qz64pzg
…“Expansion & Activation of T Cells via the Targeting of the Immunosuppressive Ligand PS: Combination Strategy with Conventional, Targeted, and Checkpoint Inhibitor Therapy”
5-31-15: ASCO’15 Roundtable (webcast), “Raising the Immuno-Oncology Bar” - 7 panel members, incl. 3 Sloan Kettering researchers http://tinyurl.com/qxu4w2x
BAVI MOA 3-25-15: PPHM/VP Dr. Jeff Hutchins’ presentation at "Immune Checkpoint Inhibitors Conf.", Boston - PDF(34 Slides): http://tinyurl.com/ooxkhq7
BAVI MOA 2-9-15: PPHM's Dr. Bruce Freimark’s presentation at KEYSTONE "Tumor Immunology Meeting", Banff/CN – PR & Slides: http://tinyurl.com/q6cx4w6
2010-2014 ARCHIVE OF ANTI-PS/BAVITUXIMAB MOA ARTICLES/PRESENTATIONS: http://tinyurl.com/y93r4jva
- - - -Peregrine's Anti-PS Mabs:
• PGN635 (B2GPI-dep.) is Fully-Human Bavituximab=1N11=AT004 (B2GPI-depen.); Genentech studying 89Zr-PGN635 as a Tumor Imaging Agent, “indep. of cancer type”
• PGN632 (B2GPI-indep.) is the Duke-PPHM-HIV candidate=11.31=AT005; also being studied by PPHM+LSU vs. Ocular Herpes (Acute HSV-1 Keratitis), see http://tinyurl.com/cax9a4p
• PGN650 is a human F(ab’)2 fragment that targets PS expression (1st ref’d in AACR’12 #2452) – see http://tinyurl.com/76nqqkm . 124I-PGN650 is Peregrine’s PS-Imaging candidate (see http://tinyurl.com/7p7jovt )
• BETABODIES (Clipped/Nicked B2GPI - ex: KL15, “2nd-gen. PS-Targeting”) - bind to PS directly, are smaller in size (100 vs. 250KDa) and have a longer serum half-life (~5days) than natural antibodies (Bavi=~1day) – see http://tinyurl.com/khopa3d
...6-22-17: Nature(BJC): AntiPS Exosomes in Breast & Pancreatic, Alan Schroit/Rolf Brekken etal (UTSW/PPHM SAB) - Betabody KL15C being tested. http://tinyurl.com/ycrx9672
…2/17/15: UTSW/PPHM’s BetaBodies patent#8,956,616 Awarded(Granted) http://tinyurl.com/p75uyfu
Examples of anti-PD-1 drugs in development: (PD1=”Programmed Cell Death Protein 1”)
1. Merck’s Keytruda(pembrolizumab=MK-3475, formerly=labrolizumab) <=’14/Melanoma, ‘15/NSCLC, ‘16/Head&Neck
2. BMS’s Opdivo(nivolumab) <=’14/Melanoma, ’15/NSCLC & RenalCell
3. AZN/MedImmune’s MEDI0680 (formerly=AMP514)
4. GSK’s AMP-224 (collab. with Amplimmune)
Examples of anti-PD-L1 drugs in development: (PD-L1=”PD1 ligand”)
1. BMS’s BMS-936559 (MDX-1105)
2.. Roche/DNA’s Tecentriq(atezolizumab, aka MPDL3280A) <=2016/Bladder & 2L/NSCLC
3. AZN/MedImmune’s Imfinzi(durvalumab=MEDI4736)<=2015 PPHM+AZN collab. & expansion to run trials in Lung & "mult. tumor types"
4. Pfizer/Merck-KgaA’s Avelumab (formerly MSB0010718C)
7-14-14/CC: Steve Worsley (VP/BusDev) said that Peregrine is “seeking collaborators that build on other checkpoints of pathways such as PD-1, IDO, immune-stimulatory drugs, and even vaccines…” http://tinyurl.com/zor2vjs
...Interesting: PPHM KOL/SRB’r Dr. Scott Antonia’s (Moffitt-CC/Tampa) role in IDO dev: http://tinyurl.com/mol86st <=“1st to report in 2002 that IDO inhibitors delay growth of human lung cancer cells”
• Incyte’s immune checkpoint inhibitor INCB24360 is an oral inhibitor of IDO1 (indoleamine dioxygenase-1) – http://www.incyte.com
• NewLink Genetics’ immune checkpoint inhibitor indoximod is an oral inhibitor of IDO (indoleamine 2,3-dioxygenase) – http://newlinkgenetics.com
...“IDO pathway inhibitors are another class of immune check point inhibitors akin to the recently developed antibodies targeting CTLA-4 & PD-1 that represent potential breakthrough approaches to cancer therapy.”
EMPLOYEES:
"As of 4-30-17, we employed 319 full-time emps & 4 part-time emps." ('11=154/2, '12=172/2 '13=182/4 '14=180/4 '15=211/4 '16=281/3) http://tinyurl.com/yb4wulvu
8-9-17: PPHM commenced a restructuring plan… expected to be completed in Oct’17… reduced workforce by 60 emps (20%), reduced R&D from 22 to 11. http://tinyurl.com/ycrxq5tc
...On 3-18-09, CFO P.Lytle (Cowen/Boston) stated, "We have 135 emps, 85 under Avid Bioservices, and the remaining 50 emps reside at the Peregrine corp. level - 35 in R&D & 15 in G&A."
In 10-2009, Dr. Robert Garnick joined Peregrine as Head/Regulatory ( http://tinyurl.com/yga7z4x ). In his 24 years at Genentech (1984-2008; from Feb'01-Oct'08 as Senior V.P. of Regulatory, Quality & Compliance), he was responsible for 17 new product approvals, including most of DNA's top selling monoclonal antibody therapeutics such as Rituxan, Herceptin, Avastin, and Lucentis. He was responsible for all the regulated aspects of Genentech's business, including drug development, commercial production, and promotional & labeling compliance. As CEO Steve King said 6-29-11, "Rob is the ringmaster."
• See this 6-29-11 Minyanville article, "Peregrine Pharma's Secret Weapon" http://tinyurl.com/9jtnano
• Examples of Dr. Garnick's work at Genentech on Avastin (bevacizumab) approvals: http://tinyurl.com/yg7vtqa
• All of Dr. Robert Garnick's public comments (thru 3-7-2014) while at Peregrine: http://tinyurl.com/obvwyuh
SEC:
Latest 10K 4-30-17 iss. 7-14-17 http://tinyurl.com/ycxu4l5n PR: http://tinyurl.com/yb4wulvu (Cash 4-30-17=$46.8mm); Amended 8-25-17: http://tinyurl.com/yb5jq7vc
Latest 10Q 10-31-17 iss. 12-11-17 https://tinyurl.com/y75kwojs PR: https://tinyurl.com/ybycb2s6 (Cash 10-31-17=$27.7mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
PPHM's Corp. Bylaws (a/o 11-14-14): http://tinyurl.com/y8hsppea
Poison Pill adopted 3-16-06: http://tinyurl.com/yvypvh - 44-pg SEC filing: http://tinyurl.com/5m57ut BUNGLER explains in plain language: http://tinyurl.com/mft4nd6
5-15-17: Parties Settle 2013 Shareholder Derivative CA Lawsuit vs. BOD(re: Fiduciary Duties) http://tinyurl.com/y982h3rt
...7-27-17: Final Settlement Hearing - transcript excerpts, comments by Judge J. Travis Laster: http://tinyurl.com/y9m6ee59
SHARES:
Shares O/S as of 1-8-18=45,253,038 - history since 4-2006: https://tinyurl.com/y76cbyt5
...A/O 10-31-17: 39,040 warrants o/s with wgt.avg. exercise price of $17.29 -- 4,123,054 stock options outstanding at a wgt.avg. exercise price of $8.96. (pg.14 10Q)
PPHM shares were 1:7 Reverse Split eff. 7-10-17 (315mm/$.606=>45mm/$4.24) http://tinyurl.com/ycohqn6j
**NOTE: PPHM shares were 1:5 Reverse Split eff. 10-19-09 (~237mm/$.64=>~47.4mm/$3.20) http://tinyurl.com/ykuw588
...4-12-17/8K: Nasdaq Delisting Notice($1 min.), 4-10-17 deadline missed; Peregrine to Appeal for Extension http://tinyurl.com/yagoqth5
...6-7-17/8K: Hearing Panel Grants Extension until 7-21-17 (must be over $1 by 7-7-17) http://tinyurl.com/yauwzhum
12-27-13: S-3 Registration, up to $100,000,000, Common & Preferred http://tinyurl.com/ky4ufth (expired "mid Jan. 2018")
...S-3 cover: Michael A. Hedge (Leader, Life Sciences M&A team), K&L Gates LLP
...2-5-14: PPHM Announces Public Offering of 10.5% Series E Convertible Preferred Stock http://tinyurl.com/lkxsna6
...2-11-14: PPHM Raises net $16.2mm selling 700k Preferred Shares with 10.5% div. at $25/sh, convertible to common at $3/sh http://tinyurl.com/jwmsnsk (8-K)
...6/14/14-7/14/13: PPHM Raises net $9.5mm selling 400k Preferred Shares with 10.5% div. at $25/sh, convertible to common at $3/sh http://tinyurl.com/mhva3k3 (4-30-14 10-K pg. F-34; $20mm gross remaining)
...6-30-14: SABBY MGT. (led by Hal Mintz) holds 291600/PPHMP a/o 6-30-14 ($7.0mm@1.66/sh. common): http://tinyurl.com/kxezbsf
...4-13-14: PPHM Registers $30mm of 10.50% Series E Convertible Preferred Stock and $25mm ATM Common Stock in 2 424B5’s: http://tinyurl.com/lth28zj & http://tinyurl.com/kpjloar
...12-23-14: S-3 Registration, “up to $150,000,000”, Common & Preferred http://tinyurl.com/nhfr55a
A-T-M (At-The-Market) Sales 3/2009 - 7/14/17 ($272,500,000gr./34,869,747sh=$7.81/sh): http://tinyurl.com/yagmu2on
...12-29-10: ATM Agreement (up to $75mm) with MLV filed - 8K: http://tinyurl.com/2a6w76g
...3-9-12: PPHM files shelf to sell up to $150mm common stock, warrants, S3: http://tinyurl.com/7dl7pjm
...12-28-12: New ATM Agreement (up to $75mm) with MLV filed - 424B5: http://tinyurl.com/ayny2b3
…6-13-14: New ATM Agreement (up to $25mm) with MLV filed - 424B5: http://tinyurl.com/ycxje6pj
…8-7-15: New ATM Agreement (up to $20mm) with NOBLE filed - 424B5: http://tinyurl.com/q9zvw6n
…8-7-15: New ATM Agreement (up to $30mm) with MLV filed - 424B5: http://tinyurl.com/oc53ugn
...7-14-17: ALL Existing ATM's are fully exhausted - cannot do anymore until a new one is opened (and reported via 424B5), against the $67mm remaining on the orig. $150mm shelf filed 4-23-14/S-3.
INSIDER-Trans: http://tinyurl.com/ypkow8 & http://tinyurl.com/2yvlj4
Inst. Holdings (Nasdaq.com) - updated qtly, 45-days after each q/e cutoff: http://www.nasdaq.com/symbol/cdmo/institutional-holdings
Short Interest, upd. twice a month: http://tinyurl.com/552p6n ...Updates 1 day earlier: http://tinyurl.com/292xyd
Director Eric Swartz's Jan-Feb'10 Buying Streak, 100k@$3.12preR/S = 14.3k@$21.84/sh: http://tinyurl.com/yegxpvu
9-8-11: Roth arranges direct sale of 893,179sh.@$7.77 to 3 inst's, net=$6.5mm http://tinyurl.com/3otm3t5
- - - - - - - - - - - - - - - - - - - - - - -
2-8-18/13D: Group Ronin Trading/SWInvest (John Stafford III+Roger Farley+Stephen White) now owns 8.6% stake (3,892,497sh.) in CDMO
FULL HISTORY of PPHM-Ronin PR’s, Letters, 13-D’s, Form4’s, Proxy’s, etc: https://tinyurl.com/ybqvzwhg
...3,740,000 COMMON - 8.7% of 45,253,038 common O/S at 1-8-18 (total beneficial=3,892,497 if Pref. conv. x1.1905 to Common)
...128,099 PREFERRED – 7.8% of 1,647,760 preferred O/S at 11-27-17
......As a Group, ie, “people that share the furtherance of a common objective/concerted action”; 13D’s are reserved for ACTIVE INVESTORS who may be “interested in agitating for some kind of a change at the company”.
2-12-18: Peregrine’s Legacy Anti-PS IP Sold to ONCOLOGIE INC. (Boston) for $8M/upfront, $95M/milestones https://tinyurl.com/yam8gb3h
...1-8-18: Name chgs. to Avid Bioservices, Inc. (from Peregrine Pharm.) and NASDAQ Ticker chgs. to "CMDO" (Preferred: CDMOP) https://tinyurl.com/y8vhjow4
...12-26-17: Roger Lias replaces Steven King as Pres./CEO; in process of changing name to Avid Bio. and new Nasdaq Ticker https://tinyurl.com/yb34e2t8
...11-28-17: PPHM+RONIN Settle - Reconstituted 7-Member BOD (Johnson/Swartz/Pohl/King resign) https://tinyurl.com/y7g72zh4
......Full Agreement(8-K): Header: https://tinyurl.com/y8m35nax Complete Agreement: https://tinyurl.com/y7b3gkc2 PROXY/12-7-17: https://tinyurl.com/y7qprpg9
......Profiles of all 7 BOD members & Compensation as of 11-28-17: https://tinyurl.com/y9lkl4q2
.......(Joseph Carleone/Chair, Richard Hancock, Gregory Sargen, Joel McComb, Roger Lias, Mark Bamforth, Patrick Walsh)
...10-30-17: RONIN/SW-Invest issues 30-pg. PDF Presentation, “Shareholders Seeking Change” http://tinyurl.com/yc88aonq
...10-10-17: RONIN/SW-Invest PR adding 4th BOD Nominee (James Egan) and ups stakes 8.8%=>8.9% http://tinyurl.com/ya8fgsr7
...8-29-17: RONIN/SW-Invest PRELIM. Proxy Statement (14A) http://tinyurl.com/yay55u3p - includes 35-pt. chronology of events (1-17-17 thru 8-14-17) & all Ronin/SW PPHM stock trans.
...8-14-17: Ronin/SW-Invest PR commenting on PPHM's 8-11-17 PR (laying off 20% employees) http://tinyurl.com/y7hjryog
...7-20-17: Ronin/SW-Invest Letter to Employees of Peregrine; PPHM Comments http://tinyurl.com/yb6ds27s
...7-13-17: Ronin/SW-Invest Letter to Stockholders; PPHM Comments http://tinyurl.com/ybr8ycbp - Ronin nominates Gregory Sargen, Brian Scanlan, Saiid Zarrabian for election to PPHM's board at next ASM ~10-12-17.
- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
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 45,253,038 common O/S at 1-8-18 (total beneficial=4,300,992 if Pref. conv. x1.19 to Common, 9.6%)
...440,000 PREFERRED - 26.7% of 1,647,760 preferred O/S at 11-27-17
...…...9-29-17/Form4: http://tinyurl.com/y9oadloa <=No chg. in Ownership; has had <10% stake for many months due to dilution. ??
- - - - - - - - - - - - - - - - - - - -ANALYST COVERAGE:
Plus, INSTITUTIONS a/o 12-31-17: 10,001,979sh. = 22.1%
...Adj. for Tappan still @9-30-17 on Nasdaq: 8,356,872 – 2,871,000 +4,516,107 = 10,001,979
http://www.nasdaq.com/symbol/cdmo/institutional-holdings
TOP10: (with qtly chgs. Since 9-30-17):
Tappan St. Partners 4,516,107 +1,645,107 <=per 2-14-18/13G(see below)
Vanguard Group 1,442,656 -75,454
Blackrock (Larry Fink) 762,010 +708
Bandera Partners 613,037 +58,037
Renaissance Tech. 549,106 +1,916
Geode Capital Mgt. 451,352 +225,676
Wells Fargo & Co. 195,904 +78,075
Stifel Financial 195,102 -9,203
Eqis Capital Mgt. 148,176 +4,581
Quinn Opportunity 92,000 NEW
**2-14-18/13G: Tappan St.(Prasad Phatak) https://tinyurl.com/yd7xkdzg (Event date: 12-31-17)
2 Funds + P.Phatak’s personal shares:
...Partners LLC, Tappan St. Fund L.P. 1,540,000
...Tappan St. Partners Ideas Fund L.P. 2,890,000
...Prasad Phatak (Principle Owner) 86,107
Total TAPPAN: 4,516,107 (10.0%)
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 7-11-17)
a/o 9-30-17: 2,871,000 6.4% (of 45,096,081 O/S 9-11-17)
a/o 11-6-17: 3,915,611 8.7% (of 45,096,081 O/S 9-11-17)
a/o 12-31-18: 4,516,107 10.0% (of 45,253,038 O/S 1-8-18)
Final Qtly Inst. Holdings from Nasdaq:
3-31-17: 5,690,888
6-30-17: 6,834,425
9-30-17: 8,491,679
12-31-17: 10,001,979
Next post to Archive PPHM’s PS-Targeting I/P History, following its 2-12-18 sale to Oncologie Inc. This archive will be linked into iBox and easily accessible at any point going forward (towards the bottom of iBox). https://tinyurl.com/y8pq4rhc
Prev. post updated with 12-31-17 INST. HOLDINGS
Plus, INSTITUTIONS a/o 12-31-17: 10,001,979sh. = 22.1%
...Adj. for Tappan still @9-30-17 on Nasdaq: 8,356,872 – 2,871,000 +4,516,107 = 10,001,979
http://www.nasdaq.com/symbol/cdmo/institutional-holdings
TOP10: (with qtly chgs. Since 9-30-17):
Tappan St. Partners 4,516,107 +1,645,107 <=per 2-14-18/13G(see below)
Vanguard Group 1,442,656 -75,454
Blackrock (Larry Fink) 762,010 +708
Bandera Partners 613,037 +58,037
Renaissance Tech. 549,106 +1,916
Geode Capital Mgt. 451,352 +225,676
Wells Fargo & Co. 195,904 +78,075
Stifel Financial 195,102 -9,203
Eqis Capital Mgt. 148,176 +4,581
Quinn Opportunity 92,000 NEW
2-12-18: Avid Sells PS/IP to Oncologie; CDMO-Transition History
...Update: 2-12-18: Avid Sells PS-Targeting IP to Oncologie for $8M/upfront, $95MM/milestones https://tinyurl.com/yam8gb3h – see full PR and link to 2-13-18/8-K below.
= = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
2-8-18: Large Ownership Summary(40.2%) - now 18,195,468shs., 40.2% of 45,253,038 O/S at 1-8-18.
(Ronin+SW/Stafford+Farley+White, Eastern Cap./K.Dart, Institutions incl. Tappan’s 2-14-18/13G)
#1: 2-14-18/13G: Tappan St. Partners (Prasad Phatak) owns 4,516,107sh. (10.0% of 45,253,038 common O/S at 1-8-18) - see INST.OWNERSHIP below.
#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 45,253,038 common O/S at 1-8-18 (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 11-27-17
…...9-29-17/Form4: http://tinyurl.com/y9oadloa <=No chg. In Ownership; status update?
#3: 2-8-18/13G: Group Ronin Trading/SWInvest (John Stafford III+R.Farley+Stephen White) now has 8.6% stake (3,892,497sh.) in PPHM
...3,740,000 COMMON – 8.7% of 45,253,038 common O/S at 1-8-18 (total beneficial=3,892,497 if Pref. conv. x1.1905 to Common)
...128,099 PREFERRED – 7.8% of 1,647,760 preferred O/S at 11-27-17
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
10-27-17 10/17/17-10/27/17 +190,427 0 4,173,391 128,099 http://tinyurl.com/y7hslequ (14A)
2-8-18 1/22/18-2/6/18 -433,391 0 3,740,000 128,099 https://tinyurl.com/ya43sc3r
SPLITOUT 13D GROUP into Ronin(John Stafford III, R.Farley) & SW-Partners(Stephen White):
Ronin Trading (Stafford) 2,840,000 115,299 (beneficial=2,977,260)
Ronin’s Roger Farley 275,000 1,000 (beneficial=276,190)
SW-Partners (White) 625,000 11,800 (beneficial=639,047)
- - - - - - - - - - - - - - -
Plus, INSTITUTIONS a/o 12-31-17: 10,001,979sh. = 22.1%
...Adj. for Tappan still @9-30-17 on Nasdaq: 8,356,872 – 2,871,000 +4,516,107 = 10,001,979
http://www.nasdaq.com/symbol/cdmo/institutional-holdings
TOP10: (with qtly chgs. Since 9-30-17):
Tappan St. Partners 4,516,107 +1,645,107 <=per 2-14-18/13G(see below)
Vanguard Group 1,442,656 -75,454
Blackrock (Larry Fink) 762,010 +708
Bandera Partners 613,037 +58,037
Renaissance Tech. 549,106 +1,916
Geode Capital Mgt. 451,352 +225,676
Wells Fargo & Co. 195,904 +78,075
Stifel Financial 195,102 -9,203
Eqis Capital Mgt. 148,176 +4,581
Quinn Opportunity 92,000 NEW
**2-14-18/13G: Tappan St.(Prasad Phatak) https://tinyurl.com/yd7xkdzg (Event date: 12-31-17)
2 Funds + P.Phatak’s personal shares:
...Partners LLC, Tappan St. Fund L.P. 1,540,000
...Tappan St. Partners Ideas Fund L.P. 2,890,000
...Prasad Phatak (Principle Owner) 86,107
. . . . .Total TAPPAN: 4,516,107 (10.0%)
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 7-11-17)
a/o 9-30-17: 2,871,000 6.4% (of 45,096,081 O/S 9-11-17)
a/o 11-6-17: 3,915,611 8.7% (of 45,096,081 O/S 9-11-17)
a/o 12-31-18: 4,516,107 10.0% (of 45,253,038 O/S 1-8-18)
Final Qtly Inst. Holdings from Nasdaq:
3-31-17: 5,690,888
6-30-17: 6,834,425
9-30-17: 8,491,679
12-31-17: 10,001,979
Huts, total Ronin/SWIM Beneficial-Ownership a/o 2-6-18/13D is indeed 3,892,497. The 2,840,000 shares you’re showing for Ronin is ONLY the COMMON for Ronin. You’re missing the PREFERRED (x1.19 to add to common to get Beneficial), and you’re missing Ronin’s Roger Farley(beneficial=276,190) and you’re missing SW-Partners/White(beneficial=639,047), for Total Ronin/SW Beneficial of 3,892,497 as of 2-6-18.
...All from Item5 of the new 2-8-18 13D(Amend#9)/Ronin/SWIM/Roger Farley: https://tinyurl.com/ya43sc3r
Look closely to the details here:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=138549315
So, this is correct:
2-14-18: Tappan adds 600k since 11-6-18, now 4,516,107=9.98% of 45,253,038 O/S as of 1-8-18.
That makes them the largest CDMO shareholder:
1. Tappan Street (Prasad Phatak): 4,516,107 = 9.98%
2. Kenneth Dart (Eastern Capital): 4,300,992 = 9.5%
3. Ronin Trading/SWInvest: 3,892,497 = 8.6%
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)
2-8-18 1/22/18-2/6/18 -433,391 0 3,740,000 128,099 https://tinyurl.com/ya43sc3r
SPLITOUT 13D GROUP into Ronin(John Stafford III, R.Farley) & SW-Partners(Stephen White):
Ronin Trading (Stafford) 2,840,000 115,299 (beneficial=2,977,260)
Ronin’s Roger Farley 275,000 1,000 (beneficial=276,190)
SW-Partners (White) 625,000 11,800 (beneficial=639,047)
Tappan adds 600k since 11-6-18, now 4,516,107=9.98% of 45,253,038 O/S as of 1-8-18.
That makes them the largest CDMO shareholder:
1. Tappan Street (Prasad Phatak): 4,516,107 = 9.98%
2. Kenneth Dart (Eastern Capital): 4,300,992 = 9.5%
3. Ronin Trading/SWInvest: 3,892,497 = 8.6%
TAPPAN STREET Ownership 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 8.7% (of 45,096,081 O/S as of 9-11-17)
a/o 2-14-18: 4,516,107 9.98% (of 45,253,038 O/S as of 1-8-18)
2-14-18/13G: Tappan Street (Prasad Phatak) https://tinyurl.com/yd7xkdzg
Tappan hasn’t hit Nasdaq for 12-31-18 as yet (45 days):
http://www.nasdaq.com/symbol/cdmo/institutional-holdings
Added link to 2-13-18 8-K Oncologie/Sale, which contains the terms for the $8M upfront payment: “payable in 3 installments over a period of ~6.5mos; the 1st 30days after date of pur. agreement”
2-13-18/8-K: $8M upfront payment: 3 installments...
2-13-18/8-K Overview: https://tinyurl.com/yab9c6cr
...$8mm in upfront payments from Oncologie, “payable in 3 installments over a period of ~6.5mos; the 1st occurring 30 days after execution of the Pur. Agreement”.
2-12-18: Avid Sells PS/IP to Oncologie; CDMO-Transition History
Updated:
Avid Sells PS-Targeting IP to Oncologie for $8M/upfront, $95MM/milestones https://tinyurl.com/yam8gb3h – see full PR below.
= = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
11-13-17: Large Ownership Summary(39.2%) - now 17,729,779shs., 39.2% of 45,253,038 O/S at 1-8-18.
(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 8.6% stake (3,892,497sh.) in PPHM
...3,740,000 COMMON – 8.7% of 45,253,038 common O/S at 1-8-18 (total beneficial=3,892,497 if Pref. conv. x1.1905 to Common)
...128,099 PREFERRED – 7.8% of 1,647,760 preferred O/S at 11-27-17
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 45,253,038 common O/S at 1-8-18 (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 11-27-17
…...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)
2-8-18 1/22/18-2/6/18 -433,391 0 3,740,000 128,099 https://tinyurl.com/ya43sc3r
SPLITOUT 13D GROUP into Ronin(John Stafford III, R.Farley) & SW-Partners(Stephen White):
Ronin Trading (Stafford) 2,840,000 115,299 (beneficial=2,977,260)
Ronin’s Roger Farley 275,000 1,000 (beneficial=276,190)
SW-Partners (White) 625,000 11,800 (beneficial=639,047)
- - - - - - - - - - - - - - -
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 (8.7%)
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 8.7% (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
That 1-23-18 PPHM/UTSW Dovepress AntiPS/Cancer posted here:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=137906812
1-23-18/DovePress: “Antibody Targeting of Phosphatidylserine for the Detection & Immunotherapy of Cancer”
Rec: 9-6-17, Acc: 10-27-17, Pub: 1-23-18 (14 pgs.)
Olivier Belzile 1 Xianming Huang 2,3 Jian Gong 2,3 Jay Carlson 2,3 Alan J Schroit 1 Rolf A Brekken 1 Bruce Freimark 2,3
1 Hamon Center for Therapeutic Oncology Res.s, UTSW/MC/Dallas
2 Dept of Preclinical Res., Peregrine Pharm.
3 Dept of Antibody Discovery, Peregrine Pharm.
2-8-18/13D: Ronin/SWIM sells 433k shares; History of CDMO Transition
UPDATED:
2-8-18/13D (Ronin, SWIM, Roger Farley): https://tinyurl.com/ya43sc3r
Between 1-22-18 & 2-6-18, Ronin sold 333,391sh., SWIM sold 75,000sh., and Ronin Capitals’ Roger Farley (trader/equity member) sold 25,000sh.
TOTAL: 433,391 sold at avg=$3.66 – see below for more details.
=>This means Ronin/SWIM beneficial ownership moves from 4,325,889/9.6% to 3,892,497/8.6%.
= = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
11-13-17: Large Ownership Summary(39.2%) - now 17,729,779shs., 39.2% of 45,253,038 O/S at 1-8-18.
(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 8.6% stake (3,892,497sh.) in PPHM
...3,740,000 COMMON – 8.7% of 45,253,038 common O/S at 1-8-18 (total beneficial=3,892,497 if Pref. conv. x1.1905 to Common)
...128,099 PREFERRED – 7.8% of 1,647,760 preferred O/S at 11-27-17
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 45,253,038 common O/S at 1-8-18 (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 11-27-17
…...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)
2-8-18 1/22/18-2/6/18 -433,391 0 3,740,000 128,099 https://tinyurl.com/ya43sc3r
SPLITOUT 13D GROUP into Ronin(John Stafford III, R.Farley) & SW-Partners(Stephen White):
Ronin Trading (Stafford) 2,840,000 115,299 (beneficial=2,977,260)
Ronin’s Roger Farley 275,000 1,000 (beneficial=276,190)
SW-Partners (White) 625,000 11,800 (beneficial=639,047)
- - - - - - - - - - - - - - -
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 (8.7%)
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 8.7% (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
Updated Bavi Completed Trials Archive with 2 additions (in bold)...
O. 6th IST Trial: Bavi+Ipilimumab(Yervoy) vs. Adv.Melanoma (Ph1b, random, open-label, 2arms, n: 24=>3)
Protocol (UTSW): http://www.clinicaltrials.gov/ct2/show/NCT01984255
...11-10-15: UTSW chgd. ClinicalTrials to NO LONGER RECRUITING, Actual-Pts: 3
M. Tumor Imaging & Dosimetry trial of I124-PGN650 (FH-Bavi) in Adv. Solid Tumors (Ph0, open-label, 1arm, n: 12=>11)
Protocol: http://clinicaltrials.gov/ct2/show/NCT01632696
10-2017/Mol-Imag: Results of Human Testing (n=11) of 124I-PGN650 PET Imaging http://tinyurl.com/y9ofyu8o
...”Tumor targeting in Pts was less than prev. observed in animal studies… tumor uptake was quite low & not sufficient for clinical studies.”