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If Gild/Kite/CAR-T goes after PPHM, we'll get a touch of volume. As in 20-30 million volume. The market will go berserk.
I can't believe Ronin's (very accurate) nasty-grams to the old BOD and their bloody threat of a knock-down drag-out proxy fight at the ASM were all for a 2,000 liter stainless steel bio-tank at Avid.
What gives? Something's not adding up here.
Best,
Joe Six Pack
Joe, That would be true - just as Tappan is most certainly not here just for Avid - see their most recent reported holdings below courtesy of CJ - and then take a look at a few paragraphs from an article written in 2013 about the two principals and their investment philosophy.
I particularly like their statement: "We run a concentrated portfolio with a goal of 10-20 long positions, so it is very important that we love everything in the portfolio."
11-13-17/13G: Tappan St. Partners adds 1,616,927sh, now 3,915,611 (8.5% of 45,096,081). Now 3rd largest, behind Ronin and E.Capital(K.Dart). Their +1,616,927 pickup is since 8-14-17; since 6-30-17, they've added +2,259,359.
Emerging Manager Interview Series: Tappan Street Partners - 4/29/13
Over the past few years, I have interviewed a number of emerging hedge fund managers (sub $250 million in assets) across a variety on investing strategies. I meet some of these managers through friends or colleagues and am always fascinated by the investment thought processes each of these capital allocators bring to the table.
About a year ago I was introduced to Prasad Phatak and Chris Koranda of Tappan Street Partners while working through the valuation of an off the run distressed situation. I was immediately impressed by the depth and intelligence they brought to the conversation. After getting to know them, I thought they would be a great subject for our next emerging manager series. Enjoy the fantastic commentary below!
Talk about the background of Tappan Street. How did you guys connect?
[Chris] We’ve known each other now for about 13 years. We were in the same section—actually the same group in many cases—at the Undergraduate Business School at the University of Michigan. Incidentally it’s also the origin of the name Tappan Street Partners: 701 Tappan Street is the address for Michigan’s business school. Basically, for the first few years Prasad and I look the same on paper. We both were undergrads at UofM. Then we both went on to Blackstone, with Prasad in the Restructuring and Reorganization group and me in the M&A group. After that Prasad spent about 6 years at Eton Park in the US Fundamental Long/Short team and I spent a couple years at Perry Capital in the Healthcare group before going on to get my MBA at Stanford. During the course of looking at potential employment opportunities post MBA and finding ideas to pitch during interviews, I was finding so many attractive investment opportunities that might not make sense if you’re running many billions, like our former employers, but are great risk/reward opportunities for smaller amounts of capital and for things that don’t fit into the more rigid silos of other firms. For this reason the competition is just a lot lower in some of the special situations and small and mid-cap companies that we have focused on.
[Prasad] We had always kicked around the idea of starting something together since our time at Blackstone, and discussing some of the investments Chris was finding sparked those discussions again. In my case, I couldn’t act on these opportunities for the fund and my personal investment options were limited given my ongoing employment at a hedge fund. Ultimately, as we thought about launching a fund, we concluded that we could compound our personal savings at very high rates of return and we would also get the benefit of developing an intangible asset in our track record and brand name in the process. 100% of our liquid net worth is in the fund alongside our investors. We view this as a compounding vehicle for our savings over time and are looking to attract like-minded investors that understand our approach. Over the long haul, we view the quality of our LPs as our greatest asset.
Can you talk about your investment process? How does an idea go from being a potential investment to become a portfolio holding?
[Chris] In terms of sourcing ideas we have a pretty heavy focus on special situations and, as a result, we try to take a systematic approach to certain investment opportunities. A few of the things we emphasize: evaluate all spin-offs, all bankruptcies, all post-reorg equities, and all non-traditional securities issued in mergers. These are all categories that frequently experience forced selling and, wherever possible, we’d prefer to buy from a seller that is acting for non-economic reasons. In addition we like to look at asset sales, division shutdowns, and management changes. These sorts of actions are sometimes an indicator that the earnings power of a business is about to change, sometimes substantially. Overall, we think securities in these verticals are more likely to be mispriced due to some combination of non-economic selling and complexity, and thus our return on time / hit rate is likely to be higher as well. While we emphasize special situations, we also have a number of investments that we would deem to be fundamentally sound businesses that don’t fall into the categories above and this was our focus at our past employers. Ultimately, we are doing deep fundamental analysis on special situations, largely because we think our hit rate will be much higher over time.
[Prasad] On the process side, we start every potential investment by first focusing on the downside. In markets that seem to go up every day, we tend to think people become much more relaxed on the risks they are taking. Eventually, having a focus on the downside and not losing money goes a long way if the goal is to compound capital over long periods of time. During the process, we will obviously do the traditional blocking and tackling of reading every piece of public information we can find (Ks, Qs, transcripts, proxies, press, etc.), reading up on competitors and talking to various industry participants. We will come up with base and downside valuations on everything we look at, and both Chris and I will take independent looks at the investments we’re evaluating if it has the potential to be a position greater than 5% of AUM. We think having a second set of eyes on the analysis is valuable and results in better decisions over the long-run. Once we get comfortable that the investment is an attractive return potential for the risk we are taking, we will start to buy (or sell in the case of shorts). After that, we are constantly monitoring our positions and we think every day we should be evaluating new ideas against things that are already in the portfolio. We run a concentrated portfolio with a goal of 10-20 long positions, so it is very important that we love everything in the portfolio. We are looking for “great” ideas and not just “good”. In the absence of great ideas, we’d rather hold cash and wait for the fat pitch.
Tappan emphasizes investments with a clear catalyst in the next 12 to 24 months. . . . . where our thesis will be either proven correct or incorrect.
Joe, Their "love," but more importantly, their confidence, seems to have grown quite dramatically over the past months {since 6-30-17, they've added +2,259,359 shares} as they learned more and more about their investment. I like that.
Almost 50% Of Today's NASDAQ Volume Was Shorted...
Just the same old same old. And it will continue until it just stops. Could that "stop" be Imminent ??
: )
Historical Short Volume Data for PPHM Date Close High Low Volume Short Volume % of Vol Shorted Dec 12 NA NA NA 542,707 263,849 48.62 Dec 11 NA NA NA 125,901 43,534 34.58 Dec 08 NA NA NA 61,504 32,309 52.53 Dec 07 NA NA NA 89,804 43,202 48.11 Dec 06 NA NA NA 46,117 29,049 62.99
Eastcoastguy, re your post excerpted in relevant part below:
The rapid wind down of R&D, departure of Shan and the ghosting of SK tells me there is a deal framework in place. What is the trigger, more data, timing issues, or competition from multiple BP's?
. . . . . . . .
What is the IP worth? Some here think it's multiple billions but IMO we don't have enough information to make that assessment. What I do know is SK,ES and many of our legacy team have options averaging over 8/sh. We have investors like Dart and Ronin with substantial investments in this company. The marketplace will decide the value as long as it's open bidding.
As North and Jedd Wolchok have been indicating - a probable "deal framework" is coming together. A human trial design is "ready" - and will start when "the company" says GO !!! But who will be that company? That is the 64 Million Dollar question. Or is it ?
Jedd only referred to "the company" - meaning ONE. He of course did not give a name to "the company." But perhaps a review of a recent post from North might help us discover the most likely "company" to which is may be referring.
1) Dr. Wolchok did discuss more extensively the CAR-T therapy he discussed only briefly during his Wistar presentation a year earlier. He noted the FDA had approved CAR-T therapies for use in humans, specifically that of KITE.
He pointed to the recent acquisition of KITE by GILD, and also the acquisition of the private company discussed in post #s 3202239 and others[e.g.,'264, '256, '273], all in an attempt to improve the safety of such therapies that have been found unpredictably toxic--sometimes fatal as in trials by KITE and JUNO--by reason of cytokine storms. He cautioned that the administration of such therapy to patients must now be accompanied by readiness to quickly administer a mitigating steroid to control those toxicities.
I then renewed that question to ask, in light of the year of further experience, data collection, posters presented at 2017 AACR [e.g. #1651] and 2017 SITC by PPHM and MSKCC, his discussion re CAR-T [my summary in paragraph 1) above], and clinical trials begun by other NCCN members [one by JHU, another by MGH and D-F], if anything had been done by MSKCC to initiate a clinical trial in human patients? He answered by stating that an experimental design had been completed for such a trial...for what indication(s) he did not say, nor did I ask.
Rather, I asked "when will that trial design be implemented"? He said "that depends on the company." as he left the auditorium.
To lend a little more color and credence to the story - see the following excerpts from an article posted on December 10, 2017 by Jonathan Faison:
[quote]Gilead Doubles Down On CAR-T: Updates To Thesis
In my first piece I stated the following:
While many might doubt management's ability to pull off the right kind of acquisition, past deals give me the confidence to give them the benefit of the doubt. The right strategic deal at the right time is simply one of several potential upside drivers- personally, I speculate one in the $5 to $15 billion range, preferably in oncology, could be in the cards.
In August the company announced the $11.9 billion acquisition of Kite Pharma, a move which lit a fire under other CAR-T stocks including a favorite of mine bluebird bio (BLUE) that I recommended as the principal beneficiary of money flowing into the sector. If peak sales of Yescarta come in around estimates of $2 billion or so, the acquisition price would appear in hindsight to be quite acceptable.
Later in mid-October Yescarta crossed the finish line when it became the first CAR-T therapy approved by the FDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.
In the next few years I wouldn´t be surprised to see the CAR-T space continue to heat up. Apparently, Gilead´s management feels the same, as they weren´t content with the first acquisition and announced on December 7th the takeout of Cell Design Labs for $567 million.
Management is not content to be merely a pioneer in the field and wishes to jump ahead of the likes of Novartis and Juno to make its own destiny. While Cell Design Labs is a preclinical company, the company´s proprietary technology platforms synNotch and Throttle should come in handy as useful add ons to Gilead´s existing CAR-T clinical programs, including helping them to eventually expand treatment to additional oncology indications including solid tumors.
Advances in safety would also be very important going forward and a way to distinguish themselves from fierce competition.
And then finally, a short post - again from North - which quite clearly lends support to the ever growing confidence Dr. Wolchok and MSK seems to have for the future of the IP.
Realist, If you have kept up to date, Dr. Wolchok does not appear to think the PPHM mab family is worthless, does he. I will count on his opinion more than I will count on yours or vinmantoo's.
There will of course be at least several "bidders" - but GILD would seem to have the best chance of being "the company" when all the dust settles.
And it appears that the dust may be settling SOON : ) - as the following would seem to strongly suggest:
...Pg.4: “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…”
Someone painting the AH tape at 5.45 for 515 shares.
Until they don't :)
Historical Short Volume Data for PPHM Date Close High Low Volume Short Volume % of Vol Shorted Dec 08 NA NA NA 61,504 32,309 52.53 Dec 07 NA NA NA 89,804 43,202 48.11 Dec 06 NA NA NA 46,117 29,049 62.99 Dec 05 NA NA NA 79,135 38,120 48.17 Dec 04 NA NA NA 50,674 13,203 26.05 Dec 01 NA NA NA 46,843 20,588 43.95 Nov 30 NA NA NA 72,930 32,572 44.66
Golfho seems to be on the right track. Interesting how GILD has suddenly risen from the ashes in the I/O space and may yet acquire that elusive new Cornerstone Molecule. They must believe that something very exciting is on their horizon if you just take a look at their ever growing California campus.
Stock wants to go up - but someone wants it to go SLOWLY : )
Historical Short Volume Data for PPHM Date Close High Low Volume Short Volume % of Vol Shorted Dec 06 NA NA NA 46,117 29,049 62.99 Dec 05 NA NA NA 79,135 38,120 48.17 Dec 04 NA NA NA 50,674 13,203 26.05 Dec 01 NA NA NA 46,843 20,588 43.95 Nov 30 NA NA NA 72,930 32,572 44.66
It feels IMHO that shares are hard to find......Low volume with upside gaps can portend major block collection with the infamous MM's............we shall see, but the "backing-and-filling" may be ending........new highs are imminent ...
I too am happy eastcoastguy, but don't agree at all that PPHM got out because they thought they would lose the proxy fight, and don't believe for a second that PPHM is following Ronin's game plan. What is happening has been well mapped out and orchestrated. Ronin exposed very little and got involved because there was tremendous value. He took no risks.
North, yes indeed, very significant - and quite suggestive of near term "multiple, large-scale clinical studies" to follow - OvCa of course to lead the way : )
I missed the significance of many of previous Hutschi, biopharm, BioBs and other posts until I tried to catch up yesterday with posts made since last Thursday. I never realized how Precision for Medicine and MSKCC had a collaborative relationship since ~ 2013-2015.
A list of further questions might have resulted at SITC last weekend, directed to the PPHM, MSKCC and Precision for Medicine personnel my wife and I did speak with.
Just a few "highlights" from the article.
A comprehensive overview of exosomes in ovarian cancer: emerging biomarkers and therapeutic strategies
Published: 3 November 2017
............
Ovarian cancer(OvCa) is among the most common types of cancer and is the leading cause of death from gynaecological malignancies in the world [7]. More than half of OvCa patients are in an advanced stage when they see their doctors. The low survival rate and poor quality of life for patients with OvCa is in part due to the lack of early diagnostic methods and high chemoresistance rate.
We believe the exosomes has strong therapeutic potential for the diagnosis and treatment of OvCa. Therefore, it is necessary to educate clinicians and researchers in the field of Ovca in regards to exosomes. The main objective of this review is to describe recent progress in exosome research, especially therapeutically in the field of Ovca, focusing on the potential role of exosomes as novel biomarkers, as well as to introduce new methods of exosome extraction.
Compared with conventional cancer biomarkers, exosomal cargos have characteristic features that differentiate them from non-cancer exosomes. They have similar, and sometimes higher, that can be specificity and sensitivity attributed to their origin. They have excellent stability, and are detected in all body fluids, particularly in peripheral blood.
[color=red]These features make exosomes a potentially ideal biomarker of cancer [21].[/color]
Many different molecular cargos identified in OvCa-derived exosomes have drawn much attention due to their large potential in (i) early diagnosis, (ii) prognosis, (iii) drug resistance, and (iv) targeted therapy of OvCa.
Exosomal proteins also have the potential to serve as tumour staging and prognostic markers for response to treatment of ovarian cancer. Marta Szajnik et al. found that plasma from OvCa patients contained higher levels of exosomal proteins compared to plasma from patients with benign tumors or NCs (healthy controls).
Furthermore, the exosomal protein content was significantly higher in advanced stages than that of early stages. In further studies, they found that TGF-ß1 and MAGE3/6 could distinguish OvCa patients from those with benign tumours and NC. Moreover, the exosomal protein levels variably changed and were [color=red]correlated with chemotherapy efficacy [27].[/color]
With the exception of proteins and miRNAs, several bio-active molecules such as phosphatidyl-serine (PS), DNAs, glycans, and glycoprotein [44], have been reported to play an important role in exosome internalization, signal recognition, and novel vaccines. Early evidence suggests that uptake of OvCa derived-exosomes by NK cells requires PS at the exosomal surface, but the presence of PS is not sufficient [8].
The latest study by Jayanthi Lea et al. also provides proof of concept data supporting the high diagnostic power of PS detection in the blood of women with suspected ovarian malignancies [45]. Exosomes were found to contain complex glycans of the di-, tri-, and tetraantennary type with or without proximal fucose, as well as high levels of mannose glycans. The sialoglycoprotein galectin-3-binding protein (LGALS3BP) was found to be strongly enriched in exosomes, making it a potential marker for exosomes [46].
Scientist have highlighted the translational value of exosomal DNA (exoDNA) in tumour-derived exosomes due to its potential usefulness as a circulating biomarker for the early detection of cancer and metastasis. ExoDNA represents the entire genome and reflects the mutational status of parental tumour cells providing the following advantages: (i) its protection, and, thus inherent stability within exosomes [47], (ii) enriched tumour-derived exosomes found in complex plasma samples [16, 48].
Conclusion and future perspective
Exosomes play a crucial role in multiple pathophysiological procedures, such as inflammatory response, immunoregulation, tumorgenesis, tumor invasion and metastasis.
Many new findings and new hypotheses suggest the need for further research, as exosomes have great diagnostics and therapeutic potential, yet many questions remain. New methods have been explored to isolate exosomes efficiently and purely, and future studies will need to make comprehensive comparisons of these methods. Multi-Omics, such as the high-throughput expression analysis technique, will reveal critical molecules and mechanisms for the packaging of cargos.
Exosomes have shown immense potential in the early diagnosis, drug selection, prognostic evaluation, and target therapies involved in OvCa.
Nonetheless, limitations of reported studies include cell lines and a sample size. Therefore, there is a critical need for multiple, large-scale clinical studies regarding the involvement of exosomes in OvCa.
Gwen, Looks like it was business as usual today - but nonetheless up the PPS went.
Interesting : )
There is no shorting on the down ticks today with the triggering of the circuit breaker yesterday. We'll see what happens tomorrow when it is business as usual.
Historical Short Volume Data for Date Close High Low Volume Short Volume % of Vol Shorted Nov 15 NA NA NA 73,229 30,573 41.75 Nov 14 NA NA NA 65,492 25,431 38.83
And yes Jake - you make another interesting observation : )
Bandera Partners is a highly-concentrated, long biased fund with regulatory assets under management of around $196 million. The fund focuses on long-term investments in companies that are priced significantly below their intrinsic value and invests in special situations such as reorganizations and spin-offs.
TOG, strange, if the public believe RONIN will win the PPHM BoD to themselves, in a 100% control way, then shorting should be a dangerous operation, would it not.
Because I was under the impression that if RONIN wins the PPHM PPS will go UP big time? (that is with all the value the team-RONIN is going to create in good RONIN, but unfindable, traditions.)
So are we saying RONIN isn't going to win, or maybe RONIN already lost but doesn't know it yet? Just a question.
And by the way, today's PPHM PPS up move is inconsistent with explanations that have been given for yesterdays PPHM PPS down move, IMO.
As we get closer to Ronin taking the BOD to court for failing to call ASM I've noticed certain messaging. We are literally getting spammed 15 times a day with the EXACT same MESSAGE that tries to convince shareholders to vote for the current BOD. Is this confidence or desperation? Seems to me it is utter desperation, especially considering most folks can see through the nonsense.
"certain messaging" - I would agree.
"spammed 15 times a day" - have to disagree here - as it's actually more like 100 times a day.
"EXACT same MESSAGE" - Once again, I agree.
"confidence or desperation?" - Of course it's desperation.
"most folks can see through the nonsense." - That would be correct : )
Hi JamesGMS. FINRA Reporting RecordLow DailyShorting ForNovember ThruNASDAQ...
for PPHM. I'm beginning to think that it is possible we are approaching a change in how our stock trades... perhaps the last 5 days of low volume and low shorting percentage is a prelude to high volume buying frenzy???
CJ, thanks for posting the SITC information. Your contributions to the greater understanding of the science is greatly appreciated. It's worth restating and highlighting the most salient points.
RESULTS
Pre-treatment (pre-tx) samples were evaluable by qPACC for 62 (32 D+B, 30 D+P) out of the 93 pts who received ICI as next line therapy after the SUNRISE assigned treatment. High pre-tx (>=median) levels correlated with statistically significant OS benefit favoring D+B for the following biomarkers: CD3+ (HR=.37, p=.023), CD4+ (HR=.32, p=.012), CD8+ (HR=.42, p=.036), PD-1 (HR=.33, p=.017), GNLY (HR=0.25, p=.011), FoxP3 (HR=.34, p=.032), naïve CD8+ (HR=.32, p=.034), B-cells (HR=.24, p=.007), MDSC (HR=.33, p=.037) NK56+ (HR=.29, p=.026). Low (<) pre-tx levels of THF correlated with OS favoring D+B (HR=.34, p=.033). No OS difference was observed for pre-tx high or low levels for TH17, CCR6, or CD14+.
CONCLUSIONS
High pre-tx levels (>=median) of circulating immune cells including T cells, B-Cells, MDSCs, NK cells correlated with significant improvement of OS in patients who received D+B then ICI compared to D+P then ICI in the SUNRISE trial.
These results support further investigation of these markers in future bavituximab clinical trials.
RESULTS In this study, we show that irradiation of B16 melanoma causes an increase in PS expression on the surface of viable tumor and immune infiltrates. We subsequently examined the effects of combining RT with an antibody that targets PS and anti-PD-1. We found that treatment with mch1N11 synergizes with RT to improve anti-tumor activity and overall survival in tumor bearing mice.
In addition, the triple combination of mch1N11, RT and anti-PD-1 treatment displayed even greater anti-tumor and survival benefit. Analysis of the immune response in the tumors of treated animals revealed an increase in M1-like macrophages in the tumors after treatment with RT and mch1N11. In addition, analysis of the systemic immune responses revealed an increase in antigen-specific CD8 T cell infiltration in the tumors as well as increased activation, effector function and differentiation in the triple combination therapy.
CONCLUSIONS This finding highlights the potential of combining these agents to improve outcome in patients with advanced-stage melanoma and may inform the design of future clinical trials with PS targeting in multiple cancers.
And then a brief - but very important observation from a few days ago posted by North in response to one of my prior posts.
Your quotations hit the high points of current basis for our investment in the PPHM technology. . . . .
CP, It was at ACCR 17 #1651. See CJ's postings below:
shipbuilder, and PPHM has not just "a" pre-clinical study with interest and peer reviewed ACCR (or was it ASCO?) presented. It was one form Dr. Walchok @ Memorial Sloan Kettering and it when to the HEART of the CAR-T problem: TOXICITIES related to CAR-T application.
Furthermore there is NOW one CAR-T application approved by the FDA which opens possibilities for CAR-T plus PS-Targeting. I think this could become betabody application (with longer patent life) and one path of partnering/licensing IP unrelated to IO, chemo and radio work.
Given the trade-off problem between the enormous possibilities and results of CAR-T in oncology on one hand and and the Toxicity problems on the other hand CAR-T companies may be slowed down enormously.
If a DEAL for CAR-T is signed BEFORE NOV 13th, 2017 then a NEW BoD cannot hi-jack that anymore. Whoever has not yet CAR-T approved would in all cases have a big disadvantage if a company that has it approved could now give it a leap forward by removing the toxicity. All NEW clinical trials by other CAR-T companies would have a HARD TIME enrolling patients against a CAR-T without toxicity. Let alone that such early CAR-T+PS-Targeting combinations would simply get all SOC for the different cancers hands-down.
I think :) PPHM is locking the IP in so that whatever happens at the next ASM it is a DONE DEAL and they do NOT need shareholders approval for it just as RONIN wouldn't need it if he gets majority and wants to sell/license PS-targeting to befriended (possibly indirectly) companies.
This may explain that even though we have 7 nominated BoD members for the PPHM WHITE CARD we do NOT yet have a date for the ASM.
AIMO.
N40k, here’s the MSKCC/Wolchok AACR’17 #1651 you spoke of. Two things kill me about it: the TITLE they chose for it (“CAR-T + AntiPS...Eliminates Advanced Tumors...” - you don’t see that phrase much out of top scientists), and the fact Jedd Wolchok was author/co-author of 9 AACR’17 abstracts: 5 were re: human trials, one was MSKCC-only, one w/Genocea re: screening, and the ONLY 2 others, involving pre-clin. I-O testing by the MSKCC lab, were with PEREGRINE & AntiPS – that blew my mind then, and it still does.
...MORE on the PPHM+MemSloan collab here: investorshub.advfn.com/boards/read_msg.aspx?message_id=130490016
“Targeting Phosphatidylserine in Combination with Adoptive T Cell Transfer Eliminates Advanced Tumors without Off-Target Toxicities in a Melanoma Preclinical Model” <=NEW(2nd) MSK STUDY
=> Daniel Hirschhorn-Cymerman 1, Sara Sara Schad 1, Sadna Budhu 1, Zhong Hong 1, Xia Yang 1, Hutchins T. Jeff 2, Bruce D. Freimark 2, Michael J. Gray 2, Jedd Wolchok 1, Taha Merghoub [Memorial Sloan Kettering] 1=Memorial Sloan Kettering CC, NYC [ http://www.mskcc.org/research-areas/labs/jedd-wolchok ] 2=Peregrine Pharmaceuticals
…”Latest Findings from Ongoing Collaboration with Memorial Sloan Kettering (MSK) Support Potential Applications for Combining CAR T & Anti-PS in Treatment of Solid Tumors”… For this study, a team of MSK researchers led by cancer immunotherapy thought-leaders, Taha Merghoub, Ph.D. and Jedd D. Wolchok, M.D., Ph.D., evaluated and compared the anti-tumor activity and off-target toxicities of adoptive T cell transfer therapy in combination with either PS-targeting antibodies or anti-OX40 antibodies in mice with advanced melanomas.
Whereas PS-targeting and anti-OX40 demonstrated comparable tumor regression when administered in combination with transferred adoptive T cells, only the PS-targeting combination achieved these results without any off-target toxicities.
By contrast, the anti-OX40 treatment combination triggered off-target inflammatory destruction of healthy tissues. Additional study results demonstrated that the PS-targeting antibodies decreased tumor-induced immunosuppression as evidenced by a decrease in immunosuppressive regulatory T cells (Tregs) and M2 macrophages.
This finding is consistent with Peregrine’s belief that bavituximab may modulate the immunosuppressive tumor microenvironment and enhance the activity of immunotherapy agents.
Taha Merghoub, Ph.D., Co-Dir. of the Ludwig Collaborative Laboratory at MSK:
“While adoptive T cell transfer remains one of the most exciting new approaches to treating cancer, to date the toxicity associated with the treatment has limited its potential.
We are encouraged that these study results showed that the combination of anti-PS and adoptive T cell treatment led to enhanced anti-tumor effect without any evidence of additional off-target side effects.
“We believe that these findings may support potential applications for this combination in solid tumors in the future.”
Joseph Shan, Peregrine’s VP of Clinical & Regulatory Affairs:
“These study results provide further support for our belief that anti-PS agents such as bavituximab can play an important role as part of combination cancer treatments. This is directly tied to the agents’ ability to modulate the tumor microenvironment to combat the immunosuppression that limits the activity of CAR T and immunotherapies.
Importantly, we are now also seeing evidence that this targeted modulation of the tumor microenvironment by anti-PS allows for enhanced activity of these other treatments without triggering any off-target toxicities. This is opposed to other conventional immunotherapies such as anti-OX40 with systemic mechanisms of action.
We believe this advantageous tolerability profile will be a key benefit in positioning anti-PS agents for inclusion in optimal combination cancer regimens.”
Must be nice to be able to twist facts and get away with doing it. Bavi works as described but control arms perform better against Bavi then any other drug.
Miracles a good thing sometimes for some people.
Not to worry - Desperation sometimes makes people do unfortunate things.
Just some more follow up from the article flagged by Patiently:
Everyone should be sure to read it - and share it.
Here are a few more excerpts:
Shorts like to target emerging biotechnology stocks that are engaged in high risk drug development and are not widely covered by quality research analysts.
The initial and subsequent attacks are almost always triggered by some news event. Obviously, the shorts seek out negative news or an event that creates uncertainty. However, sometimes an attack can be based on a positive news event which the shorts spin to make it appear negative.
Using the ready platform afforded by the internet and social media, a blogger associated with the shorts goes to work with a negative interpretation of an event. These are usually not sophisticated analyses and are usually limited to one or two pages of text which is invariably one-sided and unbalanced. These are meant to provide “intellectual” reasons and cover for the short attack.
The most prominent of these bloggers usually have no backgrounds in biotechnology analysis or expertise in the science. I believe that in many cases, hedge fund employees actually write the articles which are cut and pasted into the comments of these bloggers.
The heart of the naked shorting scheme involves a group of hedge fund traders conspiring to steadily knock out offers for the stock and to trigger stop loss orders (This is explained later in this report). This is called walking the stock down. The power of these conspiracies is striking and in many cases allows the shorts can largely determine the price that they want the stock to trade at.
The stock weakness gives legitimacy to the contrived negative blogs. The idea is to create fear and uncertainty among investors by making all news events appear to be negatives and to fabricate new issues that the shorts hope will demoralize investors.
The first time I came up against this, my thought was that the blogger was someone who was just more cynical about the chances for success and had an opposite point of view from mine. This is understandable and common in research analysis. I wrote a respectful rebuttal to their argument.
I thought that after their rebuttal to my rebuttal, this would end the discussion. We had expressed our opposite points of view, would respectively disagree and move on. This had mainly been my experience in my Wall Street days as an analyst when I disagreed with another analyst. I was wrong.
The situation quickly escalated. In the rebuttal, the blogger accused me of being stupid, deceitful and being paid by the Company to write positive comments.
In this case, over 20 articles were then written in a period of a year. Usually, they were timed to a press release and regardless of the news and without exception each was interpreted as a major negative. A major strategy was to argue that management was lying to investors and manipulating the stock.
The stock would go down on good news, bad news and uncertain news. One of the pillars of stock manipulation is to make good news appear to be bad.
The blogger was indifferent to truth and actually would make up information that was factually incorrect. When made aware that the information was wrong, he/she would ignore it and even repeat it in later blogs.
There are a number of bloggers who participate in these attacks. Many of these bloggers appear to work together and coordinate their negative attacks. It is striking that many of these people have connections to one another. Many of them were trained at a well-known blogging site that was founded by hedge fund people.
Sophisticated use is made of the Internet and social media. Twitter is used to signal that an attack has begun.
Shorts are well connected to mainstream media and are adept at getting them to unwittingly participate in the scheme.
Vicious attacks are launched on writers who might have an opposite but hopefully more well-reasoned and balanced view. The usual line is that they are being paid by management to write positive articles.
Seeking Alpha has become very friendly to articles supporting short selling and is used extensively by the hedge funds. The site actually promotes as one of its favorite authors a person who writes only negative attack article on companies in which he claims that managements are lying and paying authors who have a positive view on the Company. In his disclosure, he states that he shorts stocks, then publishes a negative article on Seeking Alpha and states that he may cover immediately after the article is published. This seems to meet the definition of a pump and dump scheme. He also acknowledges that he is collaborating with other short sellers. I think they contribute the information for most of his articles
Seeking Alpha allows articles to be published by anonymous authors. These articles are often extremely bearish and are almost certainly written by people at hedge funds.
Hedge fund create pseudonyms and publish on a daily basis negative comments on message boards like Yahoo and Ihub.
Law suits appear after articles and allege misconduct on the part of managements and urge investors to participate in a class action lawsuit.
Initially I thought that what I now believe to be naked shorting stock manipulation was attributable to market forces. The catalyst for my changing my view was coming across a shocking You Tube commentary by Jim Cramer of CNBC fame. He explained in detail how as a hedge fund manager, he participated in schemes to manipulate stocks. If you haven’t seen this it is a must watch.
This was a wakeup call for me and for the last few years, I have been doing a great deal of work on naked shorting. As I talked to companies, I heard the same stories over and over about techniques used to drive down their stock prices and I came to believe that there was manipulation going on and that it was extensive. The names of hedge funds leading the attack kept coming up in situation after situation.
Of course, there is a lot more. Take a look at the full article. It's really quite depressing.
Of course they are - today, yesterday, everyday, until it stops. And it will - SOON : )
Historical Short Volume Data for PPHM Date Close High Low Volume Short Volume % of Vol Shorted Oct 31 NA NA NA 101,863 46,655 45.80 Oct 30 NA NA NA 168,240 81,954 48.71 Oct 27 NA NA NA 231,239 117,519 50.82 Oct 26 NA NA NA 35,630 21,555 60.50 Oct 25 NA NA NA 49,883 16,802 33.68 Oct 24 NA NA NA 183,060 92,440 50.50 Oct 23 NA NA NA 39,152 22,433 57.30
I particularly liked the following section - but everyone should read the entire article.
Invariably the scheme starts with and is perpetuated by a flurry of blogs, tweets and message board comments which proclaim that the technology is worthless; management is a band of liars and thieves; and people with a positive view on the Company are being paid by the Company. Then come the lawsuits against the Company and management by the usual group of class action law firms. Each year this scenario is played out hundreds of times.
KT, another interesting day - up another 5.70% despite the continuing headwinds.
Historical Short Volume Data for PPHM Date Close High Low Volume Short Volume % of Vol Shorted Oct 30 NA NA NA 168,240 81,954 48.71 Oct 27 NA NA NA 231,239 117,519 50.82 Oct 26 NA NA NA 35,630 21,555 60.50 Oct 25 NA NA NA 49,883 16,802 33.68 Oct 24 NA NA NA 183,060 92,440 50.50 Oct 23 NA NA NA 39,152 22,433 57.30
Thanks for your measured postings. Agree or disagree, they are a pleasant counterpoint.
Historical Short Volume Data for PPHM Date Close High Low Volume Short Volume % of Vol Shorted Oct 27 NA NA NA 231,239 117,519 50.82 Oct 26 NA NA NA 35,630 21,555 60.50 Oct 25 NA NA NA 49,883 16,802 33.68 Oct 24 NA NA NA 183,060 92,440 50.50 Oct 23 NA NA NA 39,152 22,433 57.30
North, just heard through the grapevine that one of our new BOD members just exercised some options. I have no personal knowledge of this - but the source says it's a "done deal."
I was wondering if you had any thoughts on this or could verify.
Ex, regarding the excerpted portion of your post below:
The real issue though is they had no idea of how to properly run the P3.
Hummmmm . . . Interesting statement - and a puzzling one as well.
I guess that Garnick guy must have been a real screw-up - seeing as he designed both the Phase II and the Phase III Trials.
It's so hard to get good help these days : )
Oh wait !!! It was this Rob Garnick.
Robert L. Garnick, Ph.D. Head of Regulatory Affairs
Dr. Garnick has over 30 years of experience in drug and biologic pharmaceutical development. He was formerly the Senior Vice President of Regulatory, Quality and Compliance at Genentech, Inc. Dr. Garnick spent 24 years at Genentech helping to found the biotechnology industry.
While at Genentech Dr. Garnick was responsible for the approval of over 17 drugs, biologics and medical devices.
He has extensive experience in analytical methodology, process validation, the regulatory review process both in the US and Europe and in Risk assessments. He has authored numerous scientific papers and has given numerous keynote presentations to the pharmaceutical Industry.
Wildhorses, thanks for your thoughts. Re the snippet excerpted from your post below:
Well, I can tell you that if it's the kind of deal that James laid out regarding MSK, it won't be enough for me. That's mice nuts in the biotech world. And, it really won't say anything about validation of the technology.
I agree - If this WAS IT : ) - it most certainly would not be "enough" for me either - but of course, should it happen, it would merely be a "first" mini-deal dollar-wise that, contrary to your assertion above, would serve to constitute a very clear and unequivocal MEGA VALIDATION of the IP - by a world renowned entity {MSK, Wolchok, et al} who has been intimately involved with the study, understanding, and advancement of the IP for more than two years now. And in light of their deep knowledge, understanding, and support of the IP it only makes sense that they utilize their investment arm to allow them to participate in what they now believe could be an "astronomical" : ) rise in the share price as more deals are made.
A last point - the three amigos will be stepping down soon : ) - thereby making room for at least three more BOD members.
Quote:Two sides to every contract, and if you look MSKCC/Ludwig does have an equity arm (like others engaged in research) that invests in companies. Just an idle observation....not necessarily saying that will happen here.
And as I'm sure you are aware - MSK can and does place representatives on the BOD of companies in which they invest.
Just sayin : )
James
Just for fun - anyone care to opine on what would happen to the share price immediately AFTER a PR announcing an MSK purchase of a 1% interest {approx 450,000 shares for around $2 Million} in PPHM - along with placing their representative on the BOD - thus formalizing their relationship with PPHM - and thereby immediately VALIDATING the IP ??
Two sides to every contract, and if you look MSKCC/Ludwig does have an equity arm (like others engaged in research) that invests in companies. Just an idle observation....not necessarily saying that will happen here.
And as I'm sure you are aware - MSK can and does place representatives on the BOD of companies in which they invest.
North, thanks for the info - earlier than expected : )
GILD/KITE: CAR-T medication of KITE approved by FDA for treatment of patients with advanced lymphoma. Recall earlier NVS PR.
I like GILD - and have for a long time - they still need that "cornerstone molecule" their CEO mentioned a couple years back. And with the massive infrastructure investment they've made over the past few years, they need to reestablish their pipeline growth.
I/O would seem to be the way to go - and in the CAR-T arena - GILD and NVS appear to be in the lead. I wonder what either could acquire which could give them the safety edge?
North, thanks for your continuing efforts - of course the Board has to change - and it will - quite significantly - and soon : )
To Joe - thanks for your response yesterday and your measured thoughts - but I'll have to respectfully disagree and maintain my stated position. The uptrend we're witnessing over the past week or so has had very little to do with Ronin or Mr. Eden {nice resume - most likely a very capable guy - but he won't be elected to the Board}
I liked my reference to 2012 yesterday - but in this instance with no trials to sabotage.
It won't be straight up of course - as today's {naked short impacted} results demonstrate. But deals are cooking - and a new Board is on its way - heavyweights all.
Historical Short Volume Data for PPHM Date Close High Low Volume Short Volume % of Vol Shorted Oct 11 NA NA NA 258,574 133,819 51.75 Oct 10 NA NA NA 150,764 90,001 59.70 Oct 09 NA NA NA 41,128 18,508 45.00
Threes, re your post excerpted in relevant part below:
Can We all see the pattern here. . . . Ronin make an announcement, pps goes up.
Are you serious ? Really ?
Today's move and the trend that began last week has nothing to do with Ronin - or anything they're doing - which is almost nothing at this point. But then they don't need to actually do anything do they - other than own a huge junk of PPHM. They will do well - in fact, very very well.
Over a 14% gain today on no news - and despite almost 60% naked shorting on Nasdaq. Brings back memories of 2012 : ) - but this time there is no trial to sabotage.
Historical Short Volume Data for PPHM Date Close High Low Volume Short Volume % of Vol Shorted Oct 10 NA NA NA 150,764 90,001 59.70
Not sure what happened to BioBS - but agree with your assertion.
MSK is central now - as you can put JW in the "works" column.
Cheers : )
James
BioBS, apparently you missed the fact that the reins had changed hands with the collaborations begun > 1-2 years ago with MSKCC/Ludwig and ~year ago with 3 clinical trials conducted by other elements within NCCN. Reins are "in better hands" was the phrase used yesterday by SK. The posters/abstracts of MSKCC/PPHM at AACR 2017 in April was a recent example of that. Those collaborations will continue with the aim of showing, one way or another, that Bavi works, or does not work, in a variety of human cancer indications safely and effectively.
IMO, many of your recent ad hoc observations are becoming inaccurate and irrelevant.
Like that's a good thing? Pathetic. 5.78 after the r/s. Now 3.34. Just great.
Please note the red highlighted Naked Short Sales below - just from Nasdaq - and then note the Naked Short Numbers posted earlier by 4Our for PPHMP. Sure seems "someone" was working pretty hard to keep the prices down - but nonetheless they failed.
The Shorts are losing - the IP is being validated - Ronin is now irrelevant.
James
Historical Naked Short Vol Data for PPHM Date Close High Low Volume Short Volume % of Vol Shorted Sep 11 NA NA NA 262,293 134,554 51.30% Sep 08 NA NA NA 109,671 48,451 44.18% Sep 07 NA NA NA 102,121 54,007 52.89% Sep 06 NA NA NA 61,038 28,576 46.82% Sep 05 NA NA NA 80,916 32,314 39.94% Sep 01 NA NA NA 166,106 49,286 29.67% Aug 31 NA NA NA 88,862 47,051 52.95% Aug 30 NA NA NA 65,128 44,182 67.84% Aug 29 NA NA NA 30,240 21,802 72.10% Aug 28 NA NA NA 53,755 30,521 56.78% Aug 25 NA NA NA 72,874 49,280 67.62% Aug 24 NA NA NA 43,408 16,095 37.08% Aug 23 NA NA NA 83,491 41,517 49.73% Aug 22 NA NA NA 100,205 88,848 88.67%
Last Week's FINRA Data For PPHM & PPHMP...
JamesGMS, I added Friday's FINRA data to your posted info on last weeks NASDAQ numbers for PPHM.
. . . . . . . . . . . . .
I also looked at the preferred PPHMP trading data thru NASDAQ last week:
Historical Naked Short Vol Data for PPHMP (thru NASDAQ) Date Close High Low Volume Short Volume % of Vol Shorted Sep 08 NA NA NA 3,538 3,034 85.75% Sep 07 NA NA NA 1,002 402 40.12% Sep 06 NA NA NA 1,549 948 61.20% Sep 05 NA NA NA 1,274 835 65.54%
But, while I was looking at FINRA data, I also looked at Friday's numbers for PPHMP sold thru the NYSE and was amazed to see the following:
Historical Naked Short Vol Data for PPHMP (thru NYSE) Date Close High Low Volume Short Volume % of Vol Shorted Sep 08 NA NA NA 2,230 2,230 100% Sep 07 NA NA NA 0 0 n/a Sep 06 NA NA NA 0 0 n/a Sep 05 NA NA NA 0 0 n/a
The Average Daily Naked Short Volume percentage for our holiday shortened week so far is:
46.55%
and it goes up each day.
Historical Naked Short Vol Data for PPHM Date Close High Low Volume Short Volume % of Vol Shorted Sep 07 NA NA NA 102,121 54,007 52.89% Sep 06 NA NA NA 61,038 28,576 46.82% Sep 05 NA NA NA 80,916 32,314 39.94%
Historical Naked Short Vol Data for PPHM Date Close High Low Volume Short Volume % of Vol Shorted Sep 06 NA NA NA 61,038 28,576 46.82% Sep 05 NA NA NA 80,916 32,314 39.94%
Tradero, thanks very much for your repost of Golfho's post.
One comment regarding the excerpted portion from Golfho's 2:
Again from Ronin’s first letter:
…bavituximab, a drug which has been unsuccessful in numerous clinical studies, most recently failing a Phase III SUNRISE trial in February 2016 for small cell lung cancer. It has shown similarly disappointing results for breast cancer, hepatitis C, and pancreatic cancer.
Many block buster drugs initially failed advanced clinical trials…Avastin comes to mind. And yes, the Sunrise trial failed…But it failed because the control arm far exceeded its historic average. In fact, the post-trial analysis produced and is continuing to produce, some important biomarker data.
I posted this awhile ago - but it's worth restating again now - yes, the Sunrise Trial was halted - but it most certainly did not fail - as the results came in EXACTLY as planned for and expected - which would then have resulted in an approval in late 2016 or early 2017. An associate of Dr. Garnick told me several times that Rob was VERY CONFIDENT that the B+D combo would perform as required for approval - and IT DID !!! SK's statement about the control arm performance coming out of left field was accurate - particularly when compared to the results of a similar trial {9.4 months I believe} which resulted in the approval of Opdivo.
As an aside - I wonder how everyone would feel about the current BOD if PPHM now had an approved drug on the market.
But back to now - yes, the current BOD configuration must and will change significantly. And we believe it will - soon : ) - but it will not include any of Ronin's choices. But not to worry - Ronin et al will do very well with their investment.
Enjoy the rest of your weekend and Labor Day Holiday.
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