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whippersnapper65 344 posts  |  Last Activity: 18 hours ago Member since: Jun 20, 2009
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  • BHO is a diabolical narcissist, a disgrace to the Presidency and the United States of America. He sinks to new lows every month.

  • On LinkedIn you can find the profile for Freddy Jimenez, who identifies himself as Celldex's Vice President, Law and Compliance. His profile states that he began working at Celldex in February 2016 (this month) and left a job as assistant General Counsel at Johnson and Johnson, where he had previously worked for over sixteen years. Mr. Jimenez left an established, stable and successful career at Johnson and Johnson because he thinks Celldex has a bright future and he wants to be a part of it; let's be clear about that. Read his profile on LinkedIn; you should be as impressed as I am with this hire.

    I believe this position had been advertised on the job board as "Chief Counsel, Commercial Operations".

    Celldex is recruiting a world-class team of people to lead the company to soaring heights.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Feb 17, 2016 3:34 PM Flag

    BHO snubbed Margaret Thatcher's funeral but attended Nelson Mandela's.

    There is a clear pattern of BHO doing only what serves his petty narcissism and ideological self-interest.

  • Expect Marucci to say something along those lines when he has the data in hand. Much of the BLA should have already been written by now; all that is missing are the data from ACT IV.

    Then watch what happens to the share price.

    Sentiment: Strong Buy

  • On LinkedIn you can find the profile for Ken Lepitre, who as of March 2016 (this very month) identifies himself as Celldex's Executive Director of US Sales. According to his work history, he has spent the previous fifteen years working his way up the ladder in the sales department of Sanofi-Aventis.

    Celldex will be ready to market and sell Rintega as soon as it has a license from the FDA.

    Sentiment: Strong Buy

  • Reply to

    AACR mtg

    by carlrich Mar 17, 2016 4:05 PM
    whippersnapper65 whippersnapper65 Mar 17, 2016 4:55 PM Flag

    The Varli/Nivo combination results is the only poster that really interests me at this point. I'm somewhat surprised but very pleased that BMY agreed to the release of results thus far; when asked about the combination trials, management kept emphasizing that it was up to BMY to agree to release any data, almost apologizing for BMY's apparent refusal to consent to release thus far.

    The subtitle of the poster is intriguing: "activation across multiple immune pathways without untoward immune-related adverse events". Is that a harbinger of good news? Hope so. In the EOY conference call last month Tom Davis was coy about the responses seen in the Varli/Nivo combination trials so far; he merely said that the observed activity warranted expansion into the phase 2 cohorts.

    Management knows what the data are. If the data are very good, then as disappointing as the Rintega setback is it will merely be a temporary setback.

  • whippersnapper65 by whippersnapper65 Feb 23, 2016 4:41 PM Flag

    From the 10K. You would think that management would wait on these trials until the results of ACT IV are known. But, no: it's nothing but full steam ahead.

    "Additional studies of Rintega are currently planned including:

    •A Phase 2 study of Rintega prior to and concurrent with chemoradiation and maintenance temozolomide in patients with newly diagnosed EGFRvIII-positive glioblastoma. Prior studies of Rintega in the newly diagnosed setting have initiated Rintega dosing upon completion of chemoradiation concurrent with maintenance temozolomide. This single-cohort, open label study is designed to explore the feasibility of dosing at an earlier timepoint (after surgery but prior to and concurrent with chemoradiation). The primary objective of the study is to evaluate the EGFRvIII peptide-specific immune response obtained with this dosing regimen. Secondary objectives include evaluation of anti-tumor activity, including PFS, OS, ORR and duration of response, assessment of health-related quality of life outcomes, and safety and tolerability. This study is expected to open to enrollment in the second half of 2016.

    •A Phase 2 single-arm study of Rintega with adjuvant imiquimod, a topically administered immune response modifier, in combination with Avastin in patients with recurrent EGFRvIII-positive glioblastoma. Previous studies of Rintega have utilized the immune response modifier GM-CSF. Imiquimod has broad commercial availability and could potentially serve as a second source of adjuvant if needed, especially outside the United States where GM-CSF is currently available through specialty distribution channels. The primary objective of this study is to evaluate EGFRvIII-specific immune responses. Secondary objectives include evaluation of measures of anti-tumor activity, including ORR, duration of response, PFS, and OS, and to characterize the safety and tolerability profile of this combination approach. This study is expected to open to enrollment in March of 2016."

    Sentiment: Strong Buy

  • whippersnapper65 by whippersnapper65 Feb 14, 2016 4:58 PM Flag

    As long ago as September 2013 Wedbush issued a $35 price target with the following remarks:

    ---

    "Our $35 price target is a based off of 6x multiples of our 2018 rindopepimut (global), CDX-011 (US breast cancer) and CDX-1135 (dense deposit disease, US and EU) sales, discounted back to YE:14. Upside from $35/share could come from ACT IV stopping early (potentially worth $14/share from earlier commercialization and reduced risk) and positive CDX-1127 results could add an additional $10-20/share for expectations around just the US renal cancer and melanoma opportunities," he added.

    ---

    That's a price target of $69 on the high end, assuming everything goes well with ACT-IV and Varli. CDX-1135 is no longer being developed by Celldex, but everything else is on track and has had very positive data since September 2013.

    Furthermore, the combination trials using Varli hadn't been initiated yet, and the effectiveness of PD-1/PD-L1 inhibitors hadn't been fully appreciated or demonstrated.

    Varli's value as a component of combination cancer treatments could exceed anything Wedbush imagined two-and-a-half years ago.

    Rintega's approval will generate the first revenue stream and make Celldex profitable. Glemba's approval will eventually triple the revenue Celldex had been generating from Rintega sales. All of those profits will fund further development of the pipeline. By the time Varli is approved Celldex should already have sales in excess of $1.5 billion per year, and Varli has the potential to add $8 billion on top of that.

    When those events are realized, CLDX ought to be trading over $200 per share. In five years, the share price could be over $200, and people have the chance to buy it now for only $7.25. If the market truly understood what Celldex owns and how valuable it could be in just 3-5 years, the share price would be $25-$30 right now and climb to $40 upon Rintega's approval.

    No joke: CLDX will be a major player in cancer immunotherapy over the next few years.

    Sentiment: Strong Buy

  • The company keeps hiring aggressively. Note in the job description the reference to being on the ground floor of an expanding and thriving organization. This is obviously a brand-new position.

    Overview:

    The Computer System Validation specialist will work closely with all functional areas that require validation services. Beyond providing validation services, this opportunity represents being in on the ground floor of an expanding and thriving IT organization. As part of this team, you will build the IT validation foundation by establishing best practices and standard operating procedures, and communicating the importance of these activities throughout the organization.

    Responsibilities:

    •Partner with all business units to provide IT Computer System Validation Services to implement validated systems and maintain the validated state of current systems.
    •Ensure existing systems and new systems are compliant with all applicable regulations based on their applicable use at Celldex.
    •Evaluate the compliance position of potential and existing solution providers, Develop Validation Assessments, Project Validation Plans, Installation Qualification Protocols, Operational Qualification Protocols, Performance Qualification Protocols, and Traceability Matrices for new applications.
    •Provide training to personnel executing protocols, guide the execution of validated activities, and work closely with Celldex QA to close out executed protocols
    •Develop Standard Operating Procedures that support Computer Systems Validation
    •Develop training materials and provide training to Celldex staff on Computer System Validation
    •Requires 10% travel between Celldex sites and may require occasional travel to a solution provider location

    Sentiment: Strong Buy

  • whippersnapper65 by whippersnapper65 Feb 10, 2016 9:03 PM Flag

    1. ACT IV trial stopped early for efficacy

    2. Management announces that per an agreement reached with the FDA and European regulatory agencies during BTD discussions and while exploring the possibility of approving Rintega in rGBM based on ReACT, upon the successful conclusion of ACT IV Rintega has been granted immediate conditional approval for use in treating both nGBM and rGBM until full approval can be granted 8-10 months later at the conclusion of the normal BLA filing process.

    3. Management announces that, as promised, Celldex is ready to hit the ground running and Rintega commercial manufacturing and sales will commence immediately in North America and Europe.

    That's the way it should happen, and it would obliterate every short in one fell swoop.

    Sentiment: Strong Buy

  • whippersnapper65 whippersnapper65 Feb 17, 2016 3:31 PM Flag

    Obama flew to Charleston, SC to attend the funeral -- to give the eulogy, no less -- of the pastor killed in the massacre at a largely black church last year.

    But he won't attend the funeral of a Supreme Court Justice who died while serving.

    BHO hates America, and anything he does is motivated by a personal ideology of narcissism and grabbing guns and stoking a race war in America. If BHO can't be center stage, he won't go. Everything is about himself.

    BHO an utter disgrace to the office he holds and a contemptible human being.

  • Reply to

    Regarding Cldx Data Extrapolation for ACT IV

    by tonibalili9 Feb 9, 2016 1:07 PM
    whippersnapper65 whippersnapper65 Feb 9, 2016 7:12 PM Flag

    In the early November press release with 3rd quarter results, the company guided that the event that would trigger the second interim analysis was likely to occur in late 2015 and that the analysis would be completed in early 2016.

    Even if the final remaining event didn't occur by December 31, it has assuredly happened by now.

    If there is a reason for the delay in receiving the analysis, I believe it is likely due to the DSMB having to compose a thorough data analysis report to give to the company that justifies the decision to stop the trial early for efficacy. A report like that, in which the DSMB will halt the trial, is not something to be taken or written lightly; it must provide definitive evidence and conclusive analysis to justify the decision. Literally a hundred million dollars have been spent on ACT IV, and billions of dollars of revenue are at stake in a potential FDA approval, for which the report would be the deciding factor. In such a large trial, with patients of primary consideration as well as secondary consideration and multiple outcomes of interest to investigators, there is a lot of data to organize and analyze. The DSMB can't screw it up, so it will take the time to do it correctly.

    Whereas if the DSMB were merely going to continue the trial, there would be no need to compose a thorough report because no data would be provided to the company.

    Sentiment: Strong Buy

  • Reply to

    Published today

    by cldxlong Mar 1, 2016 2:35 PM
    whippersnapper65 whippersnapper65 Mar 1, 2016 5:22 PM Flag

    If Pfizer hadn't withdrawn from the partnership to develop Rindo, Rintega would have been approved by now because the phase-3 trial would have been able to begin about a year earlier. Going it alone, Celldex had to raise capital to fund the trial and manage the trial without the benefit of an experienced, well-connected partner. As it is, Celldex owns Rintega completely so you can say that the company and investors are overall better off for Pfizer having pulled out, but Rinega would have been approved by now if not for Pfiizer's action, and perhaps the share price wouldn't be $7 right now.

    Sentiment: Strong Buy

  • Reply to

    Sanofi VP

    by fmalad Feb 15, 2016 2:26 PM
    whippersnapper65 whippersnapper65 Feb 15, 2016 2:36 PM Flag

    If that is true, it is one of the most auspicious indications that Rintega's approval is nearly in the bag and that Glemba is going to be a shoe-in for approval too. VPs in established companies with secure and comfortable jobs don't risk their futures on development-stage biotechs unless the risk/reward ratio is in strong favor of the biotech succeeding.

    Sentiment: Strong Buy

  • Reply to

    long-vrts: advice for CLDX

    by biopharma4 Mar 28, 2016 8:30 PM
    whippersnapper65 whippersnapper65 Mar 28, 2016 9:24 PM Flag

    Management is receiving real-time data from the glemba METRIC registrational trial (because the trial is open-label) and knows initial varli combination data with BMY's PD-1 inhibitor. Even with the Rintega setback, if glemba and varli prove themselves then the company will be fine and shares will become very valuable.

    Positive indications for both of those drugs are that the company has been aggressively expanding glemba trials into new indications and that it has continued to pair varli with lots of other treatments. Clinicial results must warrant such expanded testing.

    Rintega was never going to be a big money maker, but its value in the pipeline was that it would provide a source of revenue to fund ongoing operations and development of the more lucrative drugs without incurring continuing losses. Now the company's financial future is uncertain.

    ACT IV should have succeeded, and management must uncover why the control group's median survival was skewed so dramatically.

    If varli's combination trial data are positive, it would be easy to partner that drug, so there is a path forward for financing that would not be dilutive. If METRIC can fully enroll by 2H of this year, as management expects, then results should be had in 1H 2016. If positive, glemba should be approved in high gpNMB TNBC and possibly for all TNBC.

    Management may not deserve to be fired, but their compensation should be curtailed; at least there ought to be no additional grants of stock options this year. It will be interesting to read the compensation report in the proxy statement, which should be released next month. How do you reward a management team that has failed in the advancement of the late-stage product?

  • Reply to

    I was on the rintega arm

    by jimbogrey57 Mar 7, 2016 12:46 PM
    whippersnapper65 whippersnapper65 Apr 3, 2016 8:59 PM Flag

    jimbo, please continue to share with us anything you learn as a trial participant. We know Rintega works, and you're a living example of it. I know you've stated before that you have enjoyed two years PFS or something like that. Hopefully the company can figure out what went wrong with the control arm and that it will result in Rintega being approved, as should happen.

  • I realize the definitive proxy statement concerns activity during the calendar year 2015, but to read that the company is considered to have achieved 100% of its Rintega development goals is a slap in the face to all shareholders after ACT IV's trial failure.

    I have told IR of my intent to vote no on the BOD nominees and on the compensation plan as a sign of my displeasure with management at the current time, and I further told IR that executive officers should receive no grants of incentive stock option awards this year on account of the collapse of the share price over the past twelve months and the failure of ACT IV: there have been no meaningful accomplishments that merit reward.

    One good point is that nearly every executive and employee stock option grant since eight years ago or so is out of the money, and many grants will remain out of the money until the share price is much, much higher. So management has a strong incentive to rebuild shareholder value in order to prevent the bulk of their own grants from expiring worthless, if for no other reason.

    If Glemba and Varli pan out, the company, the executive officers, the employees and shareholders will make out really well, and the setback with Rintega will have been just a bump on the road. Sure, it was a nasty and unexpected bump that has made us wonder about damage to the vehicle, but in the long run it may turn out to have been minor and we'll get to our destination eventually. Still, that does not change my displeasure today, hence my intended "no" votes.

    If some major IOs also vote no, it could light a fire under management's butt.

    Sentiment: Strong Buy

  • Reply to

    Why the recent strength?

    by jmekari Apr 5, 2016 5:40 PM
    whippersnapper65 whippersnapper65 Apr 5, 2016 6:31 PM Flag

    The presentation disclosing early varli/nivo combination data is the most important one. If that shows spectacular results, albeit early results, then Celldex will be back in the game in a big way. Note the presentation's subtitle: "activation across multiple immune pathways without untoward immune-related adverse events". Sounds auspicious.

    Perhaps the data will be good enough for BMY to begin to regard its collaboration with Celldex with some degree of jealousy. Varli could be the drug that every big pharma will want to get its hands on, and that would make tiny, little, beat-down Celldex one valuable company eventually but it should at least return the share price to a reasonable valuation once again.

  • whippersnapper65 whippersnapper65 Feb 24, 2016 12:05 PM Flag

    Neshua, I just don't see that happening on its own without a major world catastrophe or a further takedown of the entire biotech sector. The market cap is already only 2X cash on hand, so the pipeline is being valued at almost nothing. Hard to believe when Rintega is a guaranteed success, whether it be March or EOY, and hard to believe when Glemba will follow right on the heels of Rintega.

    Sentiment: Strong Buy

  • Executive management owns stock option grants for many hundreds of thousands of shares that are currently worthless because the share price is below the option exercise prices.

    Here are the option grants awarded to Marucci over the past several years showing shares and exercise price. Other top executives were awarded a smaller number of shares but at the same exercise prices.

    2015: 280,000 shares at $25.41
    2014: 280,000 shares at $13.45
    2013: 280,000 shares at $16.36
    2012: 280,000 shares at $5.69
    2011: 157,850 shares at $2.80
    2010: 164,000 shares at $4.50
    2009: 129,000 shares at $8.52
    2008: 254,243 shares at $8.16

    Clearly, management has very strong motivations to get the share price back up at least around $20 in order to realize a significant return from their option grants. Every executive and board member is in the same boat as Marucci. Every lower level employee who was granted options is in the same boat.

    Management always talks about how patients are the top priority, and that may be true, but don't think for a second that these executives want all their years of toil to go without landing the pot of gold at the end of the rainbow. They want their lucrative financial gains too, and as many of them are entering their near-retirement years they will be highly motivated to get the share price back up to a level where they can exercise their options for a substantial gain.

    No executive other than Catlin ever exercised options and sold shares. That tells you how much confidence they had in Rintega's success and the eventual success of the rest of the pipeline. On the return journey up in the share price, though, if executives start to exercise options that are suddenly in the money, that could be a warning sign.

    Whether it is through commercialization or a sale of the company, management is going to work to get the share price back up to a level at which they can retire very, very comfortably by cashing out all their options for a handsome gain.

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