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  • A Patently False Lie Being Asserted By Galena (GALE) Underwriter Maxim Group On Barrons.com 7 comments
    Mar 19, 2014 7:22 PM | about stocks: GALE

    I just read a patently false report on Barrons.com regarding Galena (NASDAQ:GALE). It was posted by a contributor who copied and pasted what appears to be a press release from the Galena Underwriter, and Steve Kriegsman friend, the Maxim Group.

    Beware that, if this story is audited, Ben Levisohn is a liar, and under the belief that his story is responsible for a "dead cat bounce" of GALE today. Maxim Group's Echo He would be in the same category if she was correctly quoted, unless you interpret her comments out 8 years.

    They claim that Galena is working on a Ph3 SPA Trial with NeuVax. These PR maneuvers by the companies underwriters contain patently false and/or misleading information they attach investment value too. ALL easily researched as such by using a basic search at clinicaltrials.gov.

    This claim comes directly from the 2013 Year End and 2014 Guidance Press Release & 10K filing. As they do with many things, they post vague commentary and guidance, so as to be "interpreted" and used by anyone to further their personal agenda.

    In FACT, what the 2014 Guidance states is that Galena has a GOAL set to initiate a NeuVax Ph3 SPA (Special Protocol Analysis) with the FDA in 2014. With the credibility issues at hand, lawsuits burning cash, they have no hope of funding to completion a 700 person study under the strict constraints established for a very specific minority of Breast Cancer post treatment patients.

    I cannot imagine a circumstance by which Galena, with current management will ever have the ability to raise the funding to bring to market a breakthrough Cancer Vaccine that already has a very dubious background, including being affective for a very small minority of a small minority of breast cancer victims.

    I am personally sickened by the continual false PR being passed around as NEWS among Underwriters, Pumpers on Blogs, and likely management at Public Companies who are breaking the law. This is the same behavior I have witnessed FOX News perpetrating. In their case, a local affiliate will publish an "opinion" piece in the early morning, and by the evening "news," the National Syndicate is touting the story as TRUTH. In 12 hours, a placed lie becomes reality - and it seems that some greedy management folks are willing to do the same with our money, hope for cures, and need to feed their egos.

    Following are the link to the Barrons.com article, and both the Galena and NeuVax pages at Clinicaltrials.gov:

    blogs.barrons.com/stockstowatchtoday/201...

    www.clinicaltrials.gov/ct2/resultsterm=N...

    www.clinicaltrials.gov/ct2/results?term=...

    Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

    Additional disclosure: I feel it necessary to continue daily reviews of all companies associated with Steve Kriegsman until such time that he is no longer a decision maker in the world of BioTech.

    Stocks: GALE
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  • jackryanjr
    , contributor
    Comments (151) | Send Message
     
    Author’s reply » This isn't an essay to get into college like you might write. I retired in my 30's with 3 University Degrees from top 3 UC schools. I started and sold 3 extremely profitable businesses I am very proud of, and have continued to create profit for their acquisition partners and new owners. It makes no difference to me that a school-child is unable to accept anything they disagree with.

     

    Facts copied From clintrials:
    Estimated Enrollment: 700
    Study Start Date: November 2011
    Estimated Study Completion Date: May 2022

     

    I have deleted NO COMMENTS. I received a notice MY COMMENTS were deleted this morning, and when I looked - it appears all comments were deleted. They are IP tracking now - so they know when you comment as multiple people, which is one reason I was informed comments were deleted - in addition to disallowed "language."

     

    This drug - NeuVax - from RXi, who got it from apthera... was supposed to enter a Ph3 2 years ago. The original Study Data placed on a company filing stated they hoped to monetize the combined breast/colon cancer patients for a total market of approximately 24,000. They also assumed 200K new breast cancers a year. At GALE, it is as if none of the previous science, patient expectations, or $1.6 Billion combined HER2 opportunity was reality - Thus the lengthy overhaul and FDA label negotiations to eventually start the Ph3 study years late.

     

    2022 is now stated in the SPA, which I actually did not believe was still in place after the renegotiated label post RXi... and by post RXi, the story is a murky study in how a CEO like Steve Kriegsman has never taken a product to market, and been CEO of a supposed dozen companies...

     

    You would do a solid if you focused your University time on unravelling the web, or nest, of Steve Kriegsman from the 90's forward... I have, and I am also a lead in two, and expanding, derivative lawsuits against SK and his revolving BOD/cronies. Had lunch with a VP today worried this might taint his/her career and wondering what thoughts I had to avoid the blackmark. The CMO at the company in question has stated "he will leave and recommends the same" if SK sinks the ship rather than leave on his own accord.

     

    This is all real - based in actual facts - not an orgy of rumors based on re-printed out of context quotes taken to push or refute a pps position of a trader.

     

    http://bit.ly/1gvDKZj
    24 Mar 2014, 08:31 PM Reply Like
  • MichaelJ8
    , contributor
    Comments (857) | Send Message
     
    Grats on retiring in your 30's. I hope to get there myself in a few years...

     

    However, you seem to be all over the place and its hard to follow you. It just seems like your calling everyone a liar, and I just don't follow your logic.

     

    first: "They claim that Galena is working on a Ph3 SPA Trial with NeuVax. "

     

    ... I thought GALE already got SPA: from GALE's website:

     

    "Based on a successful Phase II trial, which achieved its primary endpoint of disease free survival (DFS), the Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (http://bit.ly/LBLoir) for a Phase III clinical trial in adjuvant therapy of women with low-to-intermediate (also known as HER2-Negative, not eligible for Herceptin) status."

     

    Also you write:

     

    "Thus the lengthy overhaul and FDA label negotiations to eventually start the Ph3 study years late."

     

    It wasn't really years late... it was one year later. RXI was planning on doing phase III in 1H 2012.... GALE started phase III in 2H 2013... I agree would have been better to start in 2012, but it wasn't that huge of a set back.

     

    You also write:

     

    "and likely management at Public Companies who are breaking the law"

     

    Notice the word "likely' in there. SEC investigation will materialize to nothing, of course this is my opinion.

     

    2022 is the study completion end point. But 2015 is the primary completion end date. GALE can file for approval at this time, even if the study completion date is 2022, its the primary completion date that matters here. The 2022 study completion means that they will follow the trial participants for an additional 7 years to collect data, this is a very good thing.

     

    And all this stuff about Steve K, I'm not sure about.... I admit I should do some DD on him, but either way, its hard to tell what your getting at.

     

    the Barrons article is short, and I see nothing really wrong with it.
    27 Mar 2014, 07:06 PM Reply Like
  • jackryanjr
    , contributor
    Comments (151) | Send Message
     
    Author’s reply » Look, I am quite tired of being insulted and called names by you and the other 2. I will still be cordial. I am not saying you or anyone else are liars - the story was.

     

    Let me clear some things up:
    Last year I became increasingly uncomfortable with how Steve K was acting, making decisions, and imposing his will on various BOD's, and what amount to cronie cep's. I decided to take on a long project - trying to create a "wall of crazy" ala Homeland that might allow me to disseminate Steve's Corporate Background. There is no wall of course, but the results are horrifying.

     

    Most important - No company he has ever created, owned, birthed, operated, or otherwise been directly involved - has brought a drug to market. NONE.

     

    There is a tangle of off-shoot companies that exist for moments in time, are funded with a couple of million, never file corporate docs, then suspended, then go away. These happen to be stated on Corp Filings as having a CEO directly related to a Kriegsman project, often a closed one.

     

    Steve lists in his BIO, in its various iterations that he was the CEO of dozens of companies. ON paper yes. They often follow the above script. Universally, they are "founded" by Steve, never do anything, and only exist for a short period of time. Some M&A of compounds on the cheap. PR & IR - IPO - PUMP, Exercise, Move on.... Repeat M&A....

     

    It's very often like a Hedge Fund buying a company and the bringing on Debt as Profit, and re-selling with the debt on the books.

     

    Eventually you get to RXi and then of course to GALE...

     

    What I can promise is that this trend of create, IPO, PUMP & DUMP, going after retail money only - has been the Kriegsman Method since the earliest of the '90's.

     

    His groups of BOD's are the same people he has been handing money to for years. Collusion at best. RICO at worst.

     

    Science and Drug Development are not his forte. Nor does he really seem to care, except public image and his ability to get new money - another reason his vehicles change their names so frequently. It is a very unique methodology, as it is like walking atop a fence separating legal vs illegal. I don't think he will escape the SEC this time. The DTG investigation is a Red Herring.

     

    This is not conjecture, nor am I a nub. I've been in biotech since Amgen was working on developing a fat free pig. Programmed FORTRAN for missile guidance systems. I have Founded Science, Engineering, & Manufacturing Companies.

     

    GALE is completely a side-track - or - Arm of the Steve K beast I am going after. Careers are at stake. Science is at stake. Bad decisions are likely to delay and/or destroy compounds that should be life saving, alterable, extending, or curing. Mark Ahn - who is a puppet to Steve - Has made some astronomically poor decisions.

     

    You disagree with what I say - but I am only taking AHN/GALE/CRO at their word, applying that against industry standard, how well executed biotech works, and sadly ONLY find outstandingly poor choices.

     

    The most recent understanding coming in relation to the micro CRO, of which I will publish by Monday.

     

    Last Novemeber for instance, the scientist who created the NeuVax compound and idea came out stating GALE has changed data since he worked on the Ph1/2 studies. GALE immediately filed a Federal Lawsuit against him, which is progressing through the courts, and under a gag.

     

    (This is raw summary - do not take me to task over details)

     

    Finally - although your buddy thinks the site mix is OK, This is going to be hard to present to the FDA. RUSSIA is not the place to operate 25% of your study - PERIOD. There are some great sites there, and it is getting better over the last decade, but the simple fact that health care is provided for free by joining a study, and not available without, taints appearance.... as does the FACT that several sites have recently made overtures akin to demanding money (a bribe) to keep the site active.

     

    I am not interested in being yelled at or discussing what I know further. The 3 amigos attack what 1 of you is disseminating. Whoever it is believes they understand corporate governance and how decisions are made in a very odd manner. Someone even thought it odd a member of BOD is only compensated $65,000....

     

    In essence, I know what I know, have decades of experience, and am being YELLED DOWN by a group of 3 Amigos on a bully pulpit. Whether you guys believe you understand more than you do, are just pushing your position, or simply angry you are losing money is outside my knowledge or care really. That said it is very irritating to have three people attack me with: ignorant, end of story, try reading, try thinking, demanding I prove while you just throw out dirt, not answering questions except by ignoring them or asking un-related.... and most of all, taking out of context everything I say & trying very hard to discredit me because someone in group is a know-it-all with VERY limited experience. I'm guessing someone has done some lab work. Someone was a CRA. Someone was or is a manager.... ALL believing they KNOW how every aspect of a company functions. And for the last statement, the distortion you are accepting is light-years from reality.

     

    Finally - I wish you the best of luck in your career. If your BIO is true, use your MBA to seek a position in Business Development, who next to EVP's are the highest paid people in the industry. (200 - 500K) At the top, if you get to a company with all A people, pedigree matters although it can be trumped by graduation position in class.

     

    ( I also very well understand the dates. primary outcomes, secondary. You need to compensate all of your thinking to patient 700 plus 3 full years... plus data reviews, studies, outcomes, and FDA presentation... any final label issues, etc. You are still assuming their original timeline, which failed start by 2 years, and is not anywhere near enrollment. They MIGHT meet enrollment by 2015, although I doubt it. If so, final DATA collection is in 2018 with ZERO delays, and I can already point to more that are currently taking place.)
    28 Mar 2014, 03:00 PM Reply Like
  • MichaelJ8
    , contributor
    Comments (857) | Send Message
     
    don't know where you think I was calling you names or being insulting, I wasn't and I didn't in my last post.

     

    It just seems like you have it out against Steve K, which I have no opinion on. But I look forward to your report you will publish Monday.

     

    They actually initiated the phase III trial in Jan 2012. so its been two years now. Do you know exactly how many patients are enrolled yet? I don't, however, they claim final patient will be enrolled in 2014 in their recent annual report. So, yes, perhaps 2015 is too early, and 2018 is probably worst case scenario, were looking at 2017 more likely(or if 139 events occur, which could happen sooner). But I thank you for reminding me of this fact.
    28 Mar 2014, 03:24 PM Reply Like
  • jackryanjr
    , contributor
    Comments (151) | Send Message
     
    Author’s reply » CAPS are for emphasis not YELLING.

     

    I make no effort to utilize correct terminology, verbiage, etc on this layman's site- excepting where it comes out as natural speech for amongst my friends.

     

    This is only the most basic throw-up of the platform on which I believe Galena stands. And by throw-up, I mean quick vomit of info off the top of my head.

     

    Please simply read the HISTORICAL CHANGES at clintrials. You will find that although the start date, enrollment dates, recruitment dates have all been pushed years forward from ORIGINAL filing, they have failed to EVER update the END/FINAL DATES.

     

    Here's the link so you need do no work:
    http://1.usa.gov/1jh77xS

     

    Make sure that both boxes at the top of the page are unchecked so you see the entire set of data. Note that it displays as HTML, so it might cause confusion if you're not familiar.

     

    As of last friday, they edited the entire clintrials page, in such a way I cannot find anyone who can think of a corollary.

     

    In various places last patient WAS to be in 2015. You will note that their site mix has radically changed in the last 6 months - on multiple occasions. You cannot expect enrollment at ANY center that was activated and now replaced. One article, from the co-founder of the compound, in 2011 states they dosed first patient in Jan 2011 in the PRESENT trial.

     

    You cannot move the start forward multiple years and leave the end in place. After you go through all of the changes and iterations of the protocol, you will find that the actual study is listed as starting within 1 year prior to this month - at any time - I do not know the exact date, if they are recruiting only, or if they have dosed a first patient. However, first dose is a huge milestone, so if there is no press release at galena, then they have not.

     

    The study cannot be finalized in any pre-presentational manner until patient 700 has 36 month from initial dose. Again, as a huge majority of centers have only been attached to the study in the last 12 months, there is no chance they are near enrollment, nor even close - as the methods to trial inclusion are vastly different than the marketing published - and therefore far more difficult to achieve.

     

    The absolute best case scenario, assuming they enroll and dose patient 700 by 2015, would be final data collection end of 2018. For you to understand the next years after this, please choose a drug of your own choice in a similarly sized biotech that is of similar size and in oncology. It might help if it was recently approved so the data is fresh. Look for press releases stating they dosed final patient and then the next milestone of final data and then follow to label approval.

     

    You will not find that it was 1 month or 12 after final patient finishes trial.

     

    Add to that new science, a "cancer vaccine", the FDA's high distaste for controversy, etc... Meaning the burden of proof will be more stringent on NeuVax vs something like Aldoxorubicin.

     

    The real world will cause this trial to have as many delays during as it has had leading to. The CRO is running in circles trying to certify and initiate more russian sites - ALL OF WHICH YOU WILL SEE in the history of the protocol at clintrials.

     

    I also find galenas use of clintrials to be abusive, in poor taste, and inappropriate in the current climate. When they need to look the best, behave with excellence, and be good... They are reading SA and seeing people complain they cannot find the SPA listed at clintrials... So this last change they reworded, added sections, and basically turned the page into a marketing pamphlet. WHY? Because they feel it brings weight to their marketing claims if people can see it on the FDA's own website. Meaning they have removed another layer of credibility by purposefully using the FDA's site to give the appearance that their SPA includes their current marketing mumbo-jumbo, which it ABSOLUTELY does not.

     

    The overall point - Management is terrible. There is an ongoing Federal suit called a Derivative Suit seeking to unseat the BOD and Ahn. The company continues to exhibit poor choices even while under greater scrutiny. Kriegsman. CRO is not large enough to handle a global 700 person study, which the CRO actively states. There exists a bizarre relationship between the CRO & Ahn/Galena, which I will go into later.

     

    It is just bad decision after bad decision. Even though I hope the drug works, I do not think it will be taken to market by this group. Although an ESL, the co-inventor of the compound raised significant issues related to HER-2 and the problems neuvax has in relation to the originally assumed expression levels to patient affective ratio - again why you will see protocol changes to primary endpoint goals of only DFS at 36 months vs any statement about HER-2 expression.

     

    Please also consider the longstanding oncology assessment that 60 months is the milestone of victory in breast cancer, not 36 months as the protocol states with concomitant chemo/radiation/surger... of all nodes+/neuvax. I do not know off the top of my head - but I think I read that 36 months starts at diagnosis or treatment, not post first line therapy.

     

    I will read your reply if indeed I receive one.
    You are far too anonymous for me to continue conversing.
    I believe you are gathering information for some purpose other than a pseudo-clinical discussion.

     

    EJR

     

    Post script:
    I do not have time to go back and forth with you. You have indeed called me various names and used, insinuated or hinted at various other forms of derision. (went to copy and paste only to see that you deleted all of your comments but 1 in response to an instablog)

     

    You come off as patronizing and have more than once told me "end of story," "try reading," "do you even know how to think," so on and so forth. It appears your habit for these comments began to grow with your trading confidence sometime in 2013. Furthermore, # of comments, length of time on SA, how many friends you can get to bully-up together means nothing - yet is stated by you on multiple occasions as a reason to explain to another user why they are wrong and should cease posting..... It's ridiculous and makes the 3 amigos off-putting in any legitimate setting.... which this is not.

     

    I'm not making this up - do you deny writing these things?
    28 Mar 2014, 08:42 PM Reply Like
  • MichaelJ8
    , contributor
    Comments (857) | Send Message
     
    "You are far too anonymous for me to continue conversing.
    I believe you are gathering information for some purpose other than a pseudo-clinical discussion."

     

    Are you referring to me?

     

    Your entire post seems like you did not even read a word of my last post.

     

    I wrote "But I thank you for reminding me of this fact."...I actually thanked you.

     

    I'm sorry, but up until the last few posts about the actual end dates of the clinical trails, you have really made no sense. Your argument about the clinical trial end dates is legitimate, but it is probably the only thing that is, but of course this is my opinion.

     

    Also, you write: "went to copy and paste only to see that you deleted all of your comments but 1 in response to an instablog" ... I'm not even sure what you mean by this. I don't even know how to delete my own comments after the "edit" option disappears.

     

    You also write: "yet is stated by you on multiple occasions as a reason to explain to another user why they are wrong and should cease posting..... It's ridiculous and makes the 3 amigos off-putting in any legitimate setting.... which this is not."

     

    I do not understand what that means either...who are the three amigos you write of?

     

    Anyway, good luck on your research. I do look forward to reading what you have to write. But I will refrain from commenting on your blogs anymore.
    30 Mar 2014, 05:01 AM Reply Like
  • jackryanjr
    , contributor
    Comments (151) | Send Message
     
    Author’s reply » I have one of my admin/interns cataloging everything for posts coming Monday.

     

    I read what you wrote. It is often the case that I am able to multi-task complex thoughts in a dozen directions at the same time - when I quickly write these out, unless you really understand and are aware of the source material, I can seem to be ranting with discord and no goal. However, when I write to for the purpose of being direct with a stated proof, I am quit capable of presenting cohesive, solid, and rational material. All I hope is that the reader be able to separate emotion from truth, not pick apart the minutia of details that might have a grammar or other non-essential error.

     

    It is my strong belief, and will continue as such, that Galena under the leadership of Steve Kriegsman, his sit-in CEO Mark Ahn, the companies several dozen employees, and their hand-picked (created) 700 employee CRO has little to no chance of bringing this compound to market. I also have a gut feeling science, the wording of the protocol, and the handling of the trial are on a path to failure for concomitant as well as fully different issues that will in short time begin to see the light.

     

    What I will show you is that GALE has a study in crisis. For years they stated 100 sites. In the last months they have added about 50, while substituting maybe as many as dozens more. This means they have no enrollment, no results, and no one at the Physician level of these sites willing to put their patients on the GALE protocol/neuvax.

     

    Most of what I will show is crisis and bad decisions. This includes a protocol with endpoints they are likely to fail for possibly only study design reasons, but fail nonetheless.

     

    I find it scary that a company is wooing investors, cross-promoting heavy stroking and press releases with the CRO (Contract Research Organization) running their blinded study, and by blinded, we must believe they are not sneaking peaks at data along the way. This is why you have a very "clinical" relationship with your CRO - to make sure there is no chance one might perceive a cozy relationship.

     

    In most cases, if anyone believed this was truly a breakthrough Immuno Vaccine, you would have no funding problems at Ph3, you would not have allowed (or helped form) a 700 person CRO to manage what they claim to be a multi-billion dollar opportunity. Confidence in compound would have seen this trial transition to a rescue trial with a top-line CRO at the helm.

     

    I will present multiple documents about this CRO, the innapropriate GALE/CRO relationship, and the simple fact the CRO states "they do not work outside Ph2, as they are aware they do not understand the space." They said this - not me - Their EVP, on multiple occasions. I actually feel bad with a heavy dose of disgust at all of the smoke screens surrounding a product so emotional to so many - including myself.

     

    GALE has also sued they co-developer of NeuVax to silence his dissent - as recently as Nov. 13. Again, the reason for the lawsuit comes down to money. They actually are suing for more than $100K - and they list about 10 things hurting them in one way - And I will actually throw in a few quote for you here - DIRECTLY from the lawsuit.

     

    THE IRONY AND DISGUST ARE OBVIOUS!

     

    Galena essentially states again and again that the co-inventor has challenged the way they are presenting HIS Ph1/2 results in marketing used for secondary offerings and also for pumping campaigns where retail investors are using the distorted and misleading wording to go for the retail investors money to fund their research. Secondarily, and almost comically, Galena states that he says they are committing securities fraud in making these statements. This lawsuit aside, which seeks only to quash Ioannides publishing, has come very close to writing their own story/outcome in an attack on another individual.

     

    Regarding Galena's need to obtain Retail Level Financing:
    COMPLAINT #11 (GALE's Typo's and odd phrasing)
    "Since it is still in a development stage, Galena is dependent on periodic financings to fund its drug development efforts. Galena’s ability to financings upon favorable terms, in turn, is heavily dependent on the market price of its stock. In addition, Galena’s goodwill is diminished by the Comments. The long-term damages caused by Ioannides’ demonstrably false and libelous Comments is to be determined at trial and pursuant to expert testimony."

     

    Please note the irony of this next complaint from the second section of the lawsuit complaints:
    COMPLAINT #23
    "Among other things, such Comments falsely indicated and conveyed to the reader that Galena and its officers and directors are committing securities fraud..."

     

    COMPLAINT #25
    "More Galena complaints as to the harm they have been subjected, and thus, how they will not be able to raise funds through future offerings as no one will like them. As a result of the Ioannides’ publication of the Comments, Galena has
    been injured in its profession, trade and/or business because potential strategic partners or other third parties and investors are less interested in collaborating with or otherwise investing in Galena."

     

    COMPLAINT #27
    "Since Galena is a development - stage company, it is reliant upon the capital markets for the funding necessary to pursue its business plan, which includes seeking to commercialize its main product candidate, NeuVax,™ and Ioannides has severally damaged Galena in this respect."

     

    Read for yourself the entire federal lawsuit:
    http://bit.ly/1eRo2BF

     

    http://bit.ly/1q40KQB
    4 Apr 2014, 05:13 AM Reply Like
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