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Celldex Therapeutics, Inc. (CLDX)


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  • Theresa LaValllee, former Celldex SVP for Regulatory and Precision Medicine, hired in December and quit last week, has not had her senior management position (created new for her to fill) filled by anyone else. Shows you that her position was made-up and didn't contribute anything valuable or necessary to the company's operations. If her position had been essential or important, a replacement for her would have been named when she left. Makes you wonder who else among senior management has a position that isn't justifiable. My money's on Rick Wright, Beth Crowley, Ron Pepin and Sarah Cavanaugh. What do they even discuss at senior management meetings? "So, Rick, how are Celldex's commercial operations? What are this month's numbers?" "Beth, would you please update the team on the latest new Celldex products that you've advanced?" "Ron, summarize Celldex's new partnership deal with ______ for everyone and give us an update on the company's planned business ventures in Europe." "Sarah, what is the latest news about what's being posted on the Yahoo message board?" At least Marucci, Davis, Keler and Catlin would have something meaningful to talk about and those guys are doing actual work. Those others? What do they do all day?
  • 6/21/17 NEJM: CheckMate026 Nivo PIII trial results in Stage IV/recurrent NSCLC pts published.

    Nivo not more effective than platinum chemo in this pt population. Subgroup analysis in pts with high tumor-mutation burden- and therefore more likely to produce a stronger immune response- showed Nivo superiority vs chemo. This indicates why BMY is interested in combining Nivo with CLDX's immune activator Varli.

    http://www.nejm.org/doi/full/10.1056/NEJMoa1613493#t=article

    First-Line Nivolumab in Stage IV or Recurrent Non–Small-Cell Lung Cancer — NEJM
    Original Article from The New England Journal of Medicine — First-Line Nivolumab in Stage IV or Recurrent Non–Small-Cell Lung Cancer
    www.nejm.org
  • found on google jen vrs cancer / world press.com jen is on glemba via she has june update what a courageous fight this young lady has endured! lets pray that jens stage 4 fight carries on not for the future of celldex but the future of her battle with this diasese from hell!
    Press.com
    press.com
  • Targeted Oncology article on Glemba in RMM:

    http://www.targetedonc.com/conference/asco-melanoma-2017/glembatumumab-vedotin-shows-promising-overall-response-in-advanced-melanoma

    The DOR of 6 months in this refractory MM population is impressive and the MUM results so far are similar. Even though ORR is not hitting it out of the park the disease control rate here is very positive. Hopefully the Varli and CPI data will be even more positive and glemba will be able to move to a frontline combo therapy with a CPI. Think that Anthony Tolcher is missing the point here but will let Patrick Ott tell him.

  • Atezo/1401 study a dud
    Yale began recruiting NSCLC patients in a combo trial with NY-ESO-1 positive patients back in May 2016 with a projected enrollment of 40 and a primary completion date of July 2017. Study was recently terminated due to lack of enrollment. The final enrollment was zero, which I find puzzling. In a prior trial 2 out of 2 patients who took 1401 and went on to receive an experimental checkpoint inhibitor had partial responses, which is very good for NSCLC. Earlier in the year, Celldex management said NCI & CITN would like to continue studying the combo of 1401 & 301 with an emphasis on alternate 301 dosing. NCI has several 1401 trials extending well beyond the primary completion date so there might one day still be hope for this drug.
  • Hard to understand what Sarah Cavanaugh contributes to the company that's worth $295,000 per year plus a 35% cash bonus, plus guarantees of further income in the case of termination or change of control. Maybe she pulled a page from the Beth Crowley playbook and threatened to leave unless she was promoted to senior management and given a lucrative contract.

    Marucci needs to explain why top management is so bloated without any hint of a commercial product on the horizon.
  • IGXT (MC $46 M) NDA filing for MEGA thin-flim Cialis (better than Viagra) this month =10++ BAGGER Potential ! PLEASE read this guys and then join us to make big money .GLTA

    2 US-NDA submission within 2 months ,lot of Cash and heavily underpriced at a valuation of just $46 million .1 Big drug partnered with Endo Pharma already under review by FDA market launch expected in 1H 2018 .Load up guys before she the MEGA news hit the wire and thank me later .GL

    Intelgenx (IGXT)

    MarketCap $46 Million
    Cash ~$12 Million (including convertible debt) =cash untill 2021+
    Price: 0.70

    NDA submission for tadalafil (erectile dysfunction) thin-film version of Blockbuster drug Cialis in June or July
    NDA resubmission for Rizaport (migraine) in early Q3
    Partnership for Tadalafil in 2H 2017

    http://www.biotuesdays.com/features/2017/5/11/intelgenx-has-multi-faceted-bd-approach-for-its-oral-films

    IntelGenx previously confirmed the bioequivalence of Tadalafil to Eli Lilly’s Cialis, which had sales of $1.5-billion in 2016 but faces generic competition in 2020. IntelGenx has an exclusive license for oral films from Lilly for its dosing patent, which would allow Tadalafil to enter the ED market in the U.S. free from patent litigation from Lilly. Dr. Matzen explains that Tadalafil, which offers a discrete dosing alternative, could enter the market in 2018, with up to three years of market exclusivity before Cialis is hit with generic competition.

    Tadalafil is an erectile dysfunction (ED) treatment that boasts bioequivalence with Cialis, the current leading brand, and with a successful biostudy in-hand a 505(b)(2) NDA is set to be filed any day now, meaning that a full launch should be expected in mid-2018. Cialis is already winning-out over Viagra in terms of numbers of prescriptions, which is largely down to price and efficacy, but when Tadalafil comes to market with the same product in a more convenient and discreet delivery mechanism, IntelGenX should see a massive number of customers take-up its services.

    IntelGenx has multi-faceted BD approach for its oral films
    With a burgeoning pipeline of pharmaceutical oral films, IntelGenx’s (OTCQX:IGXT; TSXV:IGX) business development strategy is focused on partnering its product pipeline along with actively meeting with potential partners to explore manufacturing
    www.biotuesdays.com
  • Questions
    Now that the executives and directors have filled their bellies at the $2.32 shareholder dilution option trough, here are the questions I'd love to have answered:
    -Why has 0158 been pushed back so many times? Safety? Lack of investigator buy in? Or is this "reason we purchased Kolltan" drug looking like another flop? Have preclinical tests been done with 0158 and Varlilumab? And what other indications besides GIST are being enrolled in P1? Last November Marucci was all jazzed up about it then earlier this year when discussing enrollment said "we believe enrollment is going.....weellllll." Hardly the same upbeat description and pushed back a year already.
    -When will we hear more about varlilumab investigator sponsored studies? Which indications are being Pursued? And Marucci mentioned varlilumab combos with vaccines, does this imply Rindo?
    -Davis seemed to tip his hand at Jefferies saying having Varlilumab on board within first five days with Glemba seems to be important. Is this from open label feedback? Is data in the fall ESMO or SITC? And when do we hear more on the expanded indications agreement with Seattle Genetics for 014? Is this for ovarian or other indications? IF Varlilumab works with glemba is Seattle Genetics the ideal ADC partner since they're owed royalties anyway and varlilumab could expand to brentuximab vedotin? Especially now that Immunomedics deal imploded.
    -Has Celldex discussed an expansion cohort with MD Anderson for varlilumab & glemba in uveal melanoma? I'm tired of this company preparing three year trials for drugs for today's landscape rather than three year trials for the drug landscape three years from now. Witness initial glemba in melanoma without taking into account CPI, the compitive landscape now forming in triple negative, improvements in SOC for Rindo control, and varlilumab/ipilimumab trial that was terminated.
  • Dr. Jeffrey Raizer is a new Celldex Executive Medical Director: https://www.linkedin.com/in/jeffrey-raizer-9403b17

    He was hired by Celldex in May 2017. There was no job listing for such a position on Celldex's website preceding his hire. Dr. Raizer was most recently a co-director of the Northwestern Brain Tumor Institute and was a principal investigator in the ACT-IV trial of Rintega.

    Some questions are in order: why would Celldex hire a doctor specializing in brain tumors to be an executive medical director (when such an opening had not been advertised) when Celldex appears to have shelved its brain tumor vaccine? What might this hire signal about Celldex's dormant Rintega program? And why would Dr. Raizer leave his seven-and-a-half year tenure as co-director of the Northwestern Brain Tumor Institute to work at Celldex if Rintega is dead? Is Dr. Raizer abandoning his specialty to pursue corporate work in general oncology now?

    Jeffrey Raizer
    View Jeffrey Raizer’s professional profile on LinkedIn. LinkedIn is the world's largest business network, helping professionals like Jeffrey Raizer discover inside connections to recommended job candidates, industry experts, and business partners.
    www.linkedin.com
  • Wasn't it Motely Fool that two weekends ago looking at three beatdown stocks said CLDX was a falling knife? Then last weekend they look like a good speculative play? Do they care one iota about credibility?
  • New BODs members. Two of three are insiders. Why is that a good thing? Why not an independent board? Should have brought in some industry folks IMO. They could have contacts that could help with much needed partnerships.
  • 3 things are consistent at the CLDX: 1. producing zero results...2. company values going down everyday... 3. Exec compensation packages (salary, bonuses, stock options, promotions, golden parachutes, hiring friends and relatives to do nothing) keep going higher and bigger every year.How can this be legal? secondary and small investors bought in to their big promises, long pipeline of curing numerous cancers..it's all faked so they can drain cash out of reserve for personal gains..they're NOT here to producing anything, nor protecting investor interests.. wake up and make them accountable to their actions.. don't believe a word they said or claim to have cured lab rats... the only thing matter is the revenue generates from the FDA approved drugs... everything is #$%$..
  • Bring back ReAct and stick it to the FDA
  • more promotions, high paying execs, but no results driven activities... key execs start bailing out ...one at a time, and back filled with their buddies to take their places to continue milking this cash cow.. company values continued to go downhill daily... drip. drip, drip 3 cents,... 5 cents... down 95% and still gong down... and key execs continued to get bigger pay raises, huger bonuses, more hiring, and grand promotions... #$%$.....
  • Be nice if it can hold it's gains at EOD. Finally broke through 2.43.
  • CLDX is up 6.17% to 2.58
  • $3 ++ please 🏇🏇🏇
  • Value Creating Event
    I keep hearing references to a value creating event from Marucci. The only comment that I heard along these lines was in response to an analyst question during the November Kolltan announcement. Shamus Fernandez asked when the next value creating event would be as part of a three part question. Marucci's response: "As far as the next timing around data I think we've said 015 in the mid to early part of 2017 would be the timing around that."
    So he apparently was referencing 0158 which was supposed to have read out by midyear this year but was pushed back to end of 2017 and then most recently pushed back again to 2018.
    According to clinicaltrials.gov on January 4, 2017 the study completion date of 0158 was pushed back from June of 2017 until March of 2018.
  • reguarding my last post msg on seeking alpha has link to filing reguarding gild purchase of koltron class c stock
  • Looks like today is a value adding event. I'd buy more if I knew what is was!