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Prana Biotechnology Limited Message Board

goutah3006 124 posts  |  Last Activity: 12 hours ago Member since: Nov 29, 2004
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  • The 48-week extension of the Phase IIa trial of PBT1 for Alzheimer's was interesting. The original Phase IIa enrolled 18 patients and lasted 36 weeks. Nine patients completed the extension. I can't remember the breakdown on placebo vs. drug, but the results for people who were on the drug for both the main trial and the extension were interesting despite the tiny sample size. ADAS-Cog scores declined slower than they would have for a similar population not receiving treatment. And MMSE scores hardly declined at all for those who received PBT1 for the full 84 weeks. But it was a tiny sample.

    The results were released in October 2004. The share price rose 20% or so over the next few days, but within a few weeks the price settled back down to the range it had been in before the results were announced.

    The IMAGINE extension had a larger sample, and some people received the drug for a full 104 weeks. So I look forward to seeing the results if and when they get released. Whether they have much of an effect on share price remains to be seen, but I'll probably hold my remaining shares until the results have been made public.

    Sentiment: Hold

  • Reply to

    A Buy if 12 month Investment Horizon?

    by schieboutz Feb 27, 2015 11:16 AM
    goutah3006 goutah3006 13 hours ago Flag

    Another point about catalysts: Clinical results are supposed to be the big catalysts for this company. They are few and far between, but they're the big kahunas that everyone anticipates. So it's worth looking at the effect of past clinical results on Prana's share price. We've had four sets of clinical result since I became a shareholder. The Phase I results for PBT2 had no discernible effect on share price. The results of the first Phase IIa trial of PBT2 for Alzheimers sent the share price up by about 50% for a day or two, after which it settled back down to where it had been before the results were announced. The results of the first Phase IIa trial of PBT2 for Huntington's (Reach2HD) caused the price to drop by about 30%, although it made up for most of this loss during the subsequent run-up in anticipation of the second Phase IIa trial of PBT2 for Alzheimer's (IMAGINE). The IMAGINE results caused the share price to drop by about 80%.

    Hope springs eternal, and a few of the true believers are always confident that the next clinical result will send the share price "to the moon" and keep it there. But bear in mind that Prana has yet to announce a new clinical trial. The only clinical results we can expect in 2015 are the results for the IMAGINE extension. There's a slight chance we might see a Phase I results for PBT434 this year. The chances of seeing results of a new Phase IIa or Phase II or Phase III trial in 2015 are zero. For that matter, given that any such trial will probably involve 12 months of dosing, the chances of seeing results in 2016 are probably very close to zero. So bear in mind that, aside from the IMAGINE extension, were unlikely to see anything beyond a Phase I result for at least two years.

    Sentiment: Hold

  • Reply to

    A Buy if 12 month Investment Horizon?

    by schieboutz Feb 27, 2015 11:16 AM
    goutah3006 goutah3006 Feb 28, 2015 5:20 PM Flag

    Most of the past catalysts for the share price, both positive and negative, have come completely out of the blue and were not predicted by anyone. Like the clinical hold order issued by the FDA, for example. That acted as a negative catalyst, sending the price crashing by 33% in one day. Or the Kelvin Lawler video from a couple of years ago, which acted as a positive catalyst that briefly sent the price up. So trying to predict future catalysts is largely futile. The only known future event is that the Alzheimer's extension results are supposed to be published before the end of June, but we don't know how those results will affect the share price. Another possible future event is an announcement that the FDA has lifted its clinical hold. But we don't know whether such an announcement will occur, let alone when it will occur. A Phase I trial of PBT434 for Parkinson's has been promised for late 2015 or early 2016. I'm not holding my breath for that one. So if you have a one-year time frame, my advice would be to invest your money instead of speculating on Prana. Find a company with a track record of producing actual revenues and profits from its operations but is currently undervalued by the market for whatever reason. And think in terms of at least a three-year timeframe instead of one year.

    Sentiment: Hold

  • Reply to

    PRAN ----to----CYTX

    by pumpdumpalerts Feb 27, 2015 11:23 AM
    goutah3006 goutah3006 Feb 27, 2015 12:13 PM Flag

    No, pumpdumpalerts, Prana isn't "about to go bankrupt". The company as of the end of CY 2014 had net current assets of more than $36 million (Australian dollars) and no long-term debt. Factoring in cash burn plus the recent round of fundraising, the company will have net current assets of more than $40 million by the end of the current quarter. Baseline cash-burn rate is about $5.6 million per year. I invite you to explain how such a company is "about to go bankrupt". But, of course, I won't see your explanation because you will be added to my ignore list about five seconds from now.

    Sentiment: Hold

  • Reply to

    The $40.5 million question

    by goutah3006 Feb 25, 2015 2:22 PM
    goutah3006 goutah3006 Feb 26, 2015 5:01 PM Flag

    Although I've seen interesting comments about partnerships and recruiting new members to Prana's executive board, I haven't yet seen any proposals from anyone here as to how Prana should make use of its existing financial resources. I'll therefore take the opportunity to bump this thread. What do you folks think? How would you plan to use $40.5 million dollars beginning April 1, 2015, if you were in charge?

    Sentiment: Hold

  • Reply to

    Partnership

    by almara1 Feb 25, 2015 8:58 PM
    goutah3006 goutah3006 Feb 26, 2015 2:29 PM Flag

    I agree that Prana has some tough decisions to make. Ergo my "$40.5 million question" thread to solicit people's ideas as to how best to utilize remaining resources. I think they have enough resources to commit to a single clinical path for the time being, whether it be AD, HD, or PD. A full Phase II trial under Aussie rules for AD, or an orphan-drug Phase III trial for HD under FDA rules if and only if the FDA lifts its hold, or Phase I and Phase IIa trials for PD.

    Sentiment: Hold

  • Reply to

    Partnership

    by almara1 Feb 25, 2015 8:58 PM
    goutah3006 goutah3006 Feb 26, 2015 12:30 PM Flag

    I don't see any reason to believe that Mr. Kempler would turn down a reasonable offer of partnership from Big Pharma at this stage of the game. I suspect that Big Pharma simply isn't excited about Prana's science. We were all hoping that the IMAGINE trial would produce results that would whet Big Pharma's appetite, but IMAGINE turned out to be a dud. Yes, I know, "strange behavior of placebo group, small sample size, underpowered to detect cognitive efficacy", blah, blah, blah.

    Sentiment: Hold

  • Reply to

    The $40.5 million question

    by goutah3006 Feb 25, 2015 2:22 PM
    goutah3006 goutah3006 Feb 25, 2015 7:03 PM Flag

    vinewood:

    Yes, a partnership with Big Pharma would be nice. The reality, unfortunately, is that Prana has been trying to get such a partnership for the past seven years, and has thus far been unsuccessful in that endeavor. And Prana probably doesn't have any more leverage to persuade Big Pharma to engage in a partnership at the present time than they had seven years ago. So hoping for Big Pharma to ride to the rescue anytime soon, while certainly a nice hope to have, is probably not much more productive than my own hope that my favorite supermodel will knock on my door this week and ask for a date.

    Based on one or two comments made by the CEO in recent years, I've concluded that Big Pharma is waiting on the sidelines until Prana produces compelling clinical results. Thus far, the most compelling clinical results produced by Prana were the results from the first Phase IIa trial of PBT2 for Alzheimer's, which were announced seven years ago. And those results were not sufficient to persuade Big Pharma to partner with Prana. The recent IMAGINE trial was designed to produce results that would entice Big Pharma into a partnership, but that trial failed miserably in this regard. Meanwhile, the Huntington's Phase IIa results were apparently not impressive enough to get Big Pharma interested, either. So Prana will probably have to go it alone through the next clinical trial. They may just barely have enough money to do a clinical trial for Huntington's (assuming they get FDA clearance) or Alzheimer's, but not both.

    Sentiment: Hold

  • When the facts change, I change my mind. The first-half report released yesterday contains more information than was contained in the 2nd-quarter report released last month (which, for example, didn't show non-cash current assets). So instead of my earlier estimate that Prana would have $33 million to work with at the end of the current quarter, I've revised this figure to $40.5 million. My revised baseline non-R&D cash-burn rate is $5.6 million per year. These numbers give Prana a bit more viability than the $33 million I'd previously used. Prana could stay in business for two years and have $29.5 million with which to conduct clinical trials and non-clinical R&D.

    Does anyone here have his own ideas as to the best way for Prana to utilize $40.5 million?

    Sentiment: Hold

  • Reply to

    1.2 million cash burn for 6 months

    by pierreluke77 Feb 24, 2015 4:03 AM
    goutah3006 goutah3006 Feb 25, 2015 12:30 AM Flag

    Using data from the first-half report and from the 2nd-quarter report, I get non-R&D cash consumption of about $2.8 million for the first half of fiscal year 2015, which works out to an annual non-R&D cash-consumption rate of about $5.6 million. Here's how I got that number:

    In the half-year report, the operating cash-flow statement shows total operating cash consumption of $8,637,807 as a single line-item, labelled "payments to suppliers and employees". I assume that this includes cash spent on R&D activities, but the half-year report does not break down the cash consumption by category. However, the operating cash-flow section in the 2nd-quarter report shows that $5,829,000 was consumed by R&D during the first half of the fiscal year. So, I subtracted one number from the other and got $2.8 million non-R&D cash consumption during the first half. I then multiplied by 2 to get $5.6 million annual non-R&D cash consumption.

    Note that the operating cash-flow section of the first-half report shows operating cash intake of $113,558 from interest and $112,842 from grants. I don't count this in my cash-consumption analysis because a grant is a one-time thing rather than a reliable source of operating income, and interest belongs more appropriately in the "cash flows from investing" section, but I guess they do things differently down under. The whole point of the exercise is to estimate how much cash Prana consumes annually, not counting direct R&D expenditures, and it appears to be about $5.6 million at the current rate. The only operating cash intake worth considering for this type of analysis would be cash generated by actual sales of actual products, which ain't happening anytime soon.

    Historically, during periods when there were no clinical trials happening, Prana's total cash consumption rate has averaged about $6 million per year, including non-clinical R&D activities.

    Sentiment: Hold

  • Reply to

    FDA hold and Prana's preferred 250mg dose

    by button4445 Feb 24, 2015 7:18 AM
    goutah3006 goutah3006 Feb 24, 2015 8:58 PM Flag

    I looked at the semi-annual report today and noticed the same thing. This may actually be good news. My new interpretation is that it's just the FDA being the FDA (i.e. pain-in-the#$%$ overly-cautious bureaucrats). My previous interpretation (that Prana wanted to massively increase the dosage into territory where it created animal toxicity problems) was wrong. Prana just wants to stick with 250 mg and the FDA is playing its nuisance role. It would have been nice if Prana had specified the dose in its initial press release instead of making us wait for the semiannual report, but that's just Prana being Prana.

    Sentiment: Hold

  • Reply to

    ITM, RFK,UTAH,PIVALDE,YKIN,ESO

    by pjemmett Feb 23, 2015 8:54 PM
    goutah3006 goutah3006 Feb 24, 2015 1:05 AM Flag

    PJ: I'll take you up on your offer. I have sent you an e-mail. Thanks!

  • Reply to

    Oops. My mistake.

    by goutah3006 Feb 23, 2015 2:12 PM
    goutah3006 goutah3006 Feb 23, 2015 6:10 PM Flag

    Thanks, pj. This is useful information. I had been assuming (incorrectly, apparently) that we might get the IMAGINE extension results next month, based on the timing of the release of the main IMAGINE results last year. The lack of data lock is a bit disconcerting. We went through this with the Reach2HD results, and it ended up costing us six months. It's also interesting to hear that the FDA's clinical hold on the Phase III HD trial caught Prana totally by surprise. I had sort of assumed as much, but wasn't certain about it.

    After nearly a decade as a Prana shareholder, I'm finally starting to lose patience with this company. By this time next year, perhaps Prana will be at $50 or whatever kadaicher's latest predictions say. Perhaps success and wealth and hallelujah-grade clinical results and partnerships with Big Pharma really are just around the corner. But after having gone around lots of corners only to find noting but more corners in the path ahead, my desire to keep going around corners is rapidly dissipating. So I'm actually glad I sold 40% of my remaining shares today.

  • Reply to

    Oops. My mistake.

    by goutah3006 Feb 23, 2015 2:12 PM
    goutah3006 goutah3006 Feb 23, 2015 3:04 PM Flag

    Done! Sold 40% of my shares just now. Did ya'll catch the action on your fancy day-trading screens? : )

    Sentiment: Hold

  • goutah3006 by goutah3006 Feb 23, 2015 2:12 PM Flag

    In an earlier post I claimed that Prana, at the current price, accounted for about 1.5% of my portfolio. I had miscalculated. It's actually 1%. The reason I caught this error just now is that I'm going through my accounts in preparation for selling about 40% of my shares in the next few minuted. So this will bring Prana down to 0.6% of my portfolio. I'm maintaining my 'hold" rating for the stock because I think I'll keep 60% of my Prana shares until the IMAGINE extension results are released.

    Sentiment: Hold

  • Reply to

    Uncertainty = the new problem

    by goutah3006 Feb 23, 2015 1:01 PM
    goutah3006 goutah3006 Feb 23, 2015 1:31 PM Flag

    Prana management does indeed seem to enjoy leaving shareholders in the dark for extended periods sometimes. I think they comply with all the relevant regulatory requirements regarding information release and distribution, but they don't seem to go out of their way to do much more than the required minimum.

    Sentiment: Hold

  • A couple of weeks ago I was still of the opinion that Prana was worth between $3 and $4 per U.S. ADR share based on what was publicly known at the time. One thing I assumed in arriving at this conclusion was that a Phase III for HD was pretty much a certainty. The recent press release has changed all that. Prana was already operating on the fringes of viability prior to this press release, meaning that Prana's options were pretty limited for the time being, and those options would remain limited until good clinical results were obtained. But at least Prana appeared to have a pretty clear-cut path for the next 2 years. However, the FDA hold, along with Prana's failure to provide clarification, introduces a new dimension of uncertainty about the next couple of years. That's why the recent 33% decline in share price was a rational reaction in my opinion rather than an overreaction. Instead of the somewhat clear-cut scenario we had envisioned (a Phase III for HD, with the possibility of a nice boost from the IMAGINE extension results if those results are impressive), we now have no idea whether there will be a Phase III for HD. It's this added layer of uncertainty that has killed the share price. That why I haven't had many answers to my $33m question, i.e. the question of what Prana can do with $33m. Two weeks ago the answer to that question would have been pretty clear, i.e. plow ahead with a minimalist Phase III for HD. But the answer is no longer clear. Perhaps we will receive news in the near future that will change things for the better. But we just don't know whether such news will materialize. Again, it's the added uncertainty that's the killer.

    Sentiment: Hold

  • Reply to

    Partial Clinical Hold - in Prana's court

    by copper725 Feb 23, 2015 11:50 AM
    goutah3006 goutah3006 Feb 23, 2015 12:07 PM Flag

    Would a second Phase IIa trial at higher dosages be something that the FDA might accept at this point? Just thinking out loud here. Looking back, can anyone explain why Prana chose 250 mg as its highest clinical dosage? Was this choice based on animal neurotoxicity studies that were already done? I know that the Phase I had dosages up to 800 mg, but dosing only lasted for one week.

    Sentiment: Hold

  • Reply to

    From the annual report

    by interestingtome Feb 23, 2015 12:30 AM
    goutah3006 goutah3006 Feb 23, 2015 1:05 AM Flag

    Again it gets back to the question: What can we do with a budget of $33m? Certainly not an Alzheimer's trial in parallel with a Huntington's trial. Probably not even a standalone Alzheimer's trial sufficiently powered to detect what needs to be detected. Perhaps a streamlined Huntington's Phase III, but maybe just barely. Money is important in this business, and not having enough money has been a perpetual problem for Prana.

    Sentiment: Hold

  • Reply to

    All the Nerds Pumping and All the Nerds Men

    by lorde_chatterly Feb 21, 2015 10:21 AM
    goutah3006 goutah3006 Feb 22, 2015 2:03 PM Flag

    ITM wrote: "Prana is rock solid with about $30m on hand and several other drugs and conditions they can test against."

    Me: Probably about $33m by the end of March, based on the latest fund-raising round. I've asked people here to propose an optimal way to use this $33m to produce compelling clinical results of some sort, given everything that is publicly known at the moment, and haven't received much response in the way of viable scenarios. Even if they were to drop everything and dust off their old plans for a full Phase II for Alzheimer's and begin enrollment tomorrow, $33m probably wouldn't be enough.

    ITM: "From this silly price any of several indications could run this past a 10 bagger from a phase2 alone. The new Parkinson's drug comes to mind."

    Me: Perhaps, but only if Prana had money to do a Phase I trial followed by a full Phase II trial for Parkinson's, which they don't. Prana has never had the money to do a full Phase II for anything, which is why they've done only Phase IIa trials.

    ITM: "From Prana's history could you let me know how many phase III trials they have run."

    Me: Zero. They were supposedly on the cusp of doing a streamlined Phase III for Huntington's under the new orphan drug designation for PBT2, but that trial has been put on hold for an indeterminate amount of time.

    Sentiment: Hold

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