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Trius Therapeutics, AŞ Message Board

pylesm 47 posts  |  Last Activity: Aug 25, 2016 6:38 PM Member since: Jan 6, 1999
  • Reply to

    Short Interest

    by weiner301 Aug 25, 2016 3:27 PM
    pylesm pylesm Aug 25, 2016 6:38 PM Flag

    Resolve the funding issue and the bleeding stops.

  • pylesm pylesm Aug 23, 2016 5:32 PM Flag

    Not sure. The lack of insider purchases could have something to do w/the June options grants. Porter was granted options on 43K shares at an exercise price of $6.22.

  • pylesm pylesm Aug 22, 2016 6:32 PM Flag

    Sometimes when a dilution is well telegraphed (expected), the stock price rises immediately thereafter. It removes uncertainty for investors. The funds could be picking up shares around 5, where they expect the secondary price to be.

  • Reply to

    CERU's drug fails in relapsed RCC

    by gloriousknight_us Aug 17, 2016 4:22 PM
    pylesm pylesm Aug 18, 2016 9:18 PM Flag

    That's mainly due to no 121 deal, lower-than-expected Onivyde sales, and poor management of operating funds.... meaning when the price is flying, dilute and build a strong cash balance. When mgmt. did the ATM at $11, that was the time to do a 10M share dilution. I see the problem as Mulroy making promises he shouldn't. A CEO should always leave open the possibility of dilution if the stock price soars.... but Mulroy promised shareholders non-dilutive funding. Now we're lucky to get $5/share on a dilution.

    I give Mulroy an A+ on the Baxalta deal, an A on getting Onivyde through approvals, but an F on managing funds to support ongoing operations.

    I own CSIQ... great management. When the stock price spiked to $30 on ITC extension, then rushed an ATM and immediately began issuing shares... and stopped when the stock price dropped below $24. That was smart, given solar is now out-of -favor and the stock price is around $14 now.

  • pylesm pylesm Aug 18, 2016 8:55 PM Flag

    TSRO's PARP inhibitor posted knock-out results. It would be a huge market if Onivyde demonstrates strong synergy w/PARP inhibitors... it's a few years away... but good thing about this trial is that it's really more like a phase II trial when you consider its duration (3 years) with PFS as a secondary endpoint.

    TSRO's results:
    PFS was met across all 500 patients with the once-daily PARP, with those testing positive for the BRCA mutation seeing a median PFS of 21 months for those on Tesaro’s candidate, compared with 5.5 months for the control group.

  • Reply to

    Same old tune, just another day

    by bigt198ou Aug 5, 2016 9:37 AM
    pylesm pylesm Aug 8, 2016 7:05 PM Flag

    IMHO the best scenario would be for Shire to take a 20+% interest in MACK. That means a lot of dilution, but the shares don't enter the float. Shire would also negotiate additional rights to the pipeline. In return MACK gets at least $200M.

    That might require that Mulroy has to go and Yassar move up to CEO, with a mandate to ultimately sell MACK to Shire. MACK's board is made whole on previous stock purchases via stock and stock option grants. The takeover price could then be lower than some of Porter's open market purchases..

  • Reply to

    Same old tune, just another day

    by bigt198ou Aug 5, 2016 9:37 AM
    pylesm pylesm Aug 7, 2016 1:06 AM Flag

    I agree it would be awful, but I don't where the "non-dilutive, non-debt" source of funds would originate.

    US rights to Onivyde could be partnered, but I'm betting mgmt. is loath to do that given they've already spent considerable time and money to develop their own sales force.

    MM-121 is unlikely to be partnered after Patritumab's failure and considering MACK couldn't come to terms w/potential partners last year.

    MM-302 is too close to data to be partnered. Too much value would be lost.

    MM-141, 151 are targeted toward subpopulations, so unlikely to be partnered so early in the clinical cycle, at least for any significant up-front payments. I think Shire has first right of refusal for 141.

    If 302 is successful (likely?), I'm confident it will be partnered. Shire has first right of refusal. The question would be whether MACK partners away all rights (US + ex-US, all indications) to gain enough funds to allow Onivyde sales to increase.

    The alternative would be to put the company up for sale, but that's unlikely before at earliest the end of 2017 after 1st line PC data available. I'm betting mgmt. wants to wait for MM-121 in 2018 before considering selling the company.

  • Reply to

    Same old tune, just another day

    by bigt198ou Aug 5, 2016 9:37 AM
    pylesm pylesm Aug 6, 2016 2:26 PM Flag

    29% growth so early in the sales cycle seems really low and was significantly below analyst's expectations, resulting in all the subsequent downgrades. Analyst's were looking for 70% growth (17M).

    No estimate was given for how long cash on hand, plus milestones and revenues, could fund operations to a future date. I'm guessing that means a secondary offering is coming. Hopefully mgmt takes advantage of the soaring biotech market and does it soon so they can at least get $5/share.

    It's very unusual for a small biotech to defer from providing that type of guidance, even though they are always careful to use words stating cash will fund operations to a certain date without locking out the possibility of raising cash before then. Obviously no company would let their cash reserve get to zero before raising new funds.

  • Reply to

    121

    by weiner301 Aug 5, 2016 1:14 PM
    pylesm pylesm Aug 6, 2016 2:03 PM Flag

    Not sure what you mean. Keytruda already approved for NSCLC. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm465444.htm

  • pylesm pylesm Aug 6, 2016 2:01 PM Flag

    The problem is that revenue projections for Onivyde are falling short of what mgmt. expected. Duration of treatment is likely significantly less than the 3.8 month estimate. Mgmt evaded this question on the Q&A (last question). They refused to give a hard number. Reading between the lines, it sounds like Oncologists are not using Onivyde for post operative patients that used Gem to shrink tumors preceeding surgery. That patient population is likely the group with the longest duration of treatment.

  • Reply to

    Lots of shares traded, IMS data?

    by biofellowtraveler Jul 29, 2016 6:18 PM
    pylesm pylesm Jul 29, 2016 7:08 PM Flag

    Also, LOTS of new OI in the Aug $6 calls... looks bullish... but just another piece in the puzzle.

  • Reply to

    Lots of shares traded, IMS data?

    by biofellowtraveler Jul 29, 2016 6:18 PM
    pylesm pylesm Jul 29, 2016 6:58 PM Flag

    IMHO looks like some retail buying pressure may have finally convinced the warrant holders to start covering their 10M share short position. Remember MACK mgmt. assumed they would cover immediately after the debt settlement in April and that SI would drop accordingly to around 10M shares.

    It appears the warrant holders sold off their newly minted 10M shares from the April debt settlement while maintaining their short position. With this week's flurry of retail buying, warrant holders may have decided to close out their short position. I guess we'll know soon enough. The daily short volume from TRS has been higher than normal, but failed to hold the share price down.

    The retail buying seems to be coming from a cabal of traders moving RYLP profits to MACK this week, based on what I've read on stocktwits. The trend is starting to attract other retail traders, so if Onivyde sales are respectable, we could see a quick run back to 7 or 8... then some profit taking as some swing traders move on. I tried to add 10K shares today, but my order didn't fill.

  • Reply to

    Europe opinion announcement

    by biofellowtraveler Jul 25, 2016 5:25 AM
    pylesm pylesm Jul 26, 2016 3:32 PM Flag

    I'm thinking once Onivyde gets EMA approval, the Abbvie trial of MM-398 and PARP inhibitor Veliparib has a green light to move forward. It wouldn't make sense to launch the trial before MM-398 was approved, given there are trial sites in the EU.

  • Reply to

    MM-121 Questions

    by pylesm Jul 22, 2016 5:45 PM
    pylesm pylesm Jul 26, 2016 3:18 PM Flag

    Thanks for your replies. That's an obvious point I missed in terms of the time between patient enrollments and how it would affect reporting of interim OS.

    I would have liked to have seen as much PFS data as possible for MM-121 w/chemo... but the lack of it is likely part of the reason the investment community appears to remain very cautious on MM-121's chances. I'm assuming the DMC will take a look at PFS H1 2017 to determine if the trial continues or not... so I see that as a significant event, especially relative to the failure of patritumab.

    I'm wondering if new treatments might be approved by the time patients begin moving off of MM-121, that might skew the OS survival data. For example, if a PD1 or PDL1 combo were to be approved, patients could move to that therapy after reaching progressive disease, with some then possibly achieving significant survival rates. I think the thought is that patients typically move to progressively less effective treatments.

  • Regarding these two slides from the MACK web site:
    1. MM-121 NSCLC trial design: http://files.shareholder.com/downloads/AMDA-IWDM2/2484766908x0x894605/51CE44D3-F048-4BA3-A489-8FBDF9739B57/MM-121-01-02-09_ASCO_Trials_in_Progress_Final.pdf

    2. MM-121 phase 1 trial results: http://www.merrimack.com/files/MM-121/Clinical%20Posters/ESMO%202014/2014%20ESMO%20biomarkers.pdf

    1. Notice the mouse model graph on slide (1) at the bottom of the left side. Does anyone know why time to clinically defined progressive disease (tumor = 500mm) stops when the control groups reach that point? Why does it not also show time to PD for the treatment groups? An unscientific estimate would be about 80 days (twice as long). Does anyone know what if the company has ever mentioned it?

    2. Doesn't it appear mgmt. is betting MM-121 w/chemo performs significantly better than MM-121 w/elinotib... for this reason. If you look at slide (1) in the box labeled "Methods" you'll see an interim analysis will be published when half of the subjects have died., Also note the trial is randomized 2:1, treatment:control. So about 300 patients where 200 get MM-121 + chemo. If you look at slide (2), notice on the right side the progression free survival graph for MM-121 + erlinotib. MM-121 appears to work well for about 35% of patients. With those observations in mind, if erlinotib were being used instead of chemo in the phase II trial, wouldn't an interim analysis after half of the subjects died, be too soon? Assuming OS mirrors PFS, only a modest improvement in OS would be observed. Wouldn't a safer interim analysis point be after 90% of subjects in the CONTROL group had died? That way you would capture the benefit of MM-121 that is seen in slide (2) after about 2 months.

    If MM-121 + chemo in the phase II trial doesn't work significantly better than MM-121 + erlinotib did in the phase I trial, it looks like the interim analysis of OS will not show significant improvement... right?

  • pylesm pylesm Jul 15, 2016 1:52 PM Flag

    If using desktop PC, log into YAHOO, then use this URL to reach old message board: https://finance.yahoo.com/mb/mack/?bypass=true&_classic=1&status=verifyfail

    Looks like all posts haven't moved over to new formatted board. Some #$%$ are changed. gloriousknight_us is Nola Housing in new format.

  • pylesm pylesm Jul 11, 2016 10:21 PM Flag

    FierceBiotech reports he will become CEO of Ipsen.

    "After Baxalta-Shire merger, David Meek lands CEO job at leaderless Ipsen"

  • Reply to

    MM-398 and PARP inhibitor Veliparib

    by gloriousknight_us Jul 9, 2016 3:06 PM
    pylesm pylesm Jul 9, 2016 7:04 PM Flag

    Niraparib, the drug that sent Tesaro parabolic recently, is a PARP inhibitor. MDVN has one as well, Talazoparib, that the CEO is using as leverage to increase Sanofi's buyout offer.

  • pylesm pylesm Jul 8, 2016 5:32 PM Flag

    Might Hannaford be interested in expanding downstate in NY and perhaps into NJ and PA?

    Hannaford bought and operated Welby Drugs in New England, then later sold those stores to Rite Aid.

  • pylesm pylesm Jul 8, 2016 12:32 PM Flag

    If you want a cheap hedge, consider buying the 2018 $10 leaps after maybe another month when RAD's price bottoms.