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Post by jckrdu on Jan 10, 2015 16:10:30 GMT
A few thoughts: -I'm relatively optimistic that we see ATHX/Pfizer move forward with the UC trial. I guess I'm basing this on 3 things: First, there's been no announcement of this partnership being discontinued. Second, the trial sites are being updated on ClinicalTrials.gov. Third, these comments from Gil indicate to me that he believes in MultiStem's ability to treat UC and feels the failure to show efficacy was due to trial design (inadequate dosing or patients beyond the treatment window). -Also, this is my first time hearing about the partnership with RTI Surgical. It doesn't seem like the map3 product by itself has the ability to generate substantial revenues, but if MultiStem is shown as being successful with this product, it would be exciting to see RTI develop additional products using MultiStem. It's not much, but any revenue is HUGE for a small-cap developing biotech. From the most recent 10-Q: We have also partnered with RTI on the development of products for certain orthopedic applications using our stem cell technologies in the bone graft substitutes market. We began recognizing royalty revenue from product sales in 2014 and may receive other payments upon the successful achievement of certain commercial milestones.
-It would be nice to get an update on the Registrational GVHD trial or the start of Phase 2 heart attack trial. Hopefully we hear something on this Tuesday at the Biotech Showcase conference. -It also seems that Gil is very optimistic about the Stroke trial data and it's ability to create shareholder value. I do think the implication of this stroke trial data is greater than the UC trial data. You would think this would directly translate to more excitement (and a higher PPS run up) before trial data is released. Before this recent Japan legislation was put in place, I might have argued that this wouldn't be the case because the UC trial is being funded by Pfizer and likely has the ability to get to commercialization far quicker than a product Athersys is bringing to market on their own. Even with the new initiatives in Japan, this argument could probably still be made. There's also the possibility that investors are hesitant to bet on MultiStem before the data is released based on the failed UC trial (using the same biologic). Regardless of all of this, I expect to see the PPS take a substantial move higher prior to the data release. Just for fun, my PPS target by mid-March is $3.50 (I have 50% of my position on a limit sell order at that price). Good post RLC. Your pps target of $3.50 by mid-March is realistic, IMO. My thinking is that ATHX will release news on the non-stroke programs (GVHD and AMI at a minimum... hopefully UC and obesity as well) sometime over the next 60 days, and that news alone will push the pps back over $2 and get it heading upwards to fill the gap over $2.70. Stroke results coming at the end of March / first part of April should keep buying pressure strong ... so IMO something over $3 by that time is very doable.
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Post by lovie350z on Jan 10, 2015 17:38:52 GMT
Opened a position early this week. Thanks for the info/updates guys!
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Post by Yelk on Jan 10, 2015 17:40:30 GMT
What would be the reason for as many sells insider trading in last 3 months as last 12 months combined? It is nearly 100% sell. I'm in either way and am very excited for ATHX but curious the cause of this. Welcome aboard Lovie.
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Post by lovie350z on Jan 10, 2015 18:01:18 GMT
Thanks Yelk, things seem to be on halt with Ocat. So looking for other potential companies!
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Post by RLC on Jan 10, 2015 18:09:20 GMT
What would be the reason for as many sells insider trading in last 3 months as last 12 months combined? It is nearly 100% sell. I'm in either way and am very excited for ATHX but curious the cause of this. Welcome aboard Lovie. You're referring to the Dec 19th sales. Those were all for tax purposes. The same thing happened last year and this is relatively typical. There's a footnote in all ATHX insider form 4s filed EOY like this that says something along these lines: " Shares sold pursuant to a predefined Rule 10b5-1 trading plan solely related to the tax obligation on the quarterly vesting of a June 2013 restricted stock unit award."The interview I just posted also had a direct response from the CEO on this: "In my view, we are substantially undervalued, and it's no secret that I have been a buyer of the stock historically and have repeatedly put my money where my mouth is. I firmly believe in this company and what we can accomplish. However, it's important for people to understand that there are times when executives and others are restricted from buying shares. There are several potential reasons for these types of restrictions, including having access to material knowledge that the rest of the market doesn't have, or due to restrictions related to SEC or other regulations that prohibit certain types of trading activity. At the moment, members of management are restricted, which is why we haven't been buying. It's not because we don't want to - it's because we can't do it without incurring meaningful penalties, and we aren't going to do that.I want people to understand that since the company was founded, I've never sold a share for personal gain, and my family has invested repeatedly. When the board put a restricted stock plan in place I and others implemented something called a 10b5-1 plan to protect against the tax liability associated with the vesting of these restricted stock grants. In accordance with that plan, which I have no control over once it's in place, the absolute minimum amount necessary to deal with the tax consequences is sold. This is done because paying those tax liabilities is not optional, and this is the most prudent way to do it, particularly if there is a big run up in stock price."
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Post by Yelk on Jan 10, 2015 18:15:25 GMT
Ah, thanks RLC Totally missed that.
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Post by RLC on Jan 10, 2015 19:45:11 GMT
In regards to insider activity... It's rare to see insiders purchase shares in companies at this stage and it's very common to see insider sales (usually due to having to pay taxes on shares they were granted as part of their compensation package). I know I've been critical of OCAT/ACTC management over the years for this, but that's just because of the expectations management set forth there and knowing that if those expectations were met, the market cap would likely be $1 billion or more so you would have expected to see at least some insider purchases in the past... There have been NONE. I guess it's clear now why.
Going back to 2007, the CEO of ATHX has made numerous insider purchases, which is always comforting as a shareholder. FWIW, I don't place too much importance on small insider buys/sells which is usually all that's seen (and has been the case with ATHX).
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Post by sethd023 on Jan 11, 2015 4:41:47 GMT
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Post by avtech on Jan 11, 2015 14:00:34 GMT
Excellent find. Thanks for sharing.
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Post by jckrdu on Jan 11, 2015 14:14:01 GMT
Great find! Just posted it on Yahoo.
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Post by jckrdu on Jan 11, 2015 15:36:18 GMT
Some key excerpts below. Bolding is mine.
They go on to say that its a double blind trial, so they don't know if the improvements they're seeing at day 30 are from patients getting Multistem or the placebo, but my guess is that the patients seeing improvement at day 30 are the ones getting Multistem, because the entry criteria for this trial is structured to identify and weed out/exclude patients that are more likely to recover on their own.
With regard to seeing results in February at that conference, it'd be interesting to know the author's source of that information. IMO, they could announce some type of top line data in February, and then more complete results later on. Until I get more confirmation direcly from the company, I'm still going to assume we'll see results in late March early April. (The market may not make that same assumption based on this article.) ____________________
For almost three years now, stroke victims at Erlanger's clinic who meet certain criteria can have stem cell treatment through a study funded by Athersys Inc., of Cleveland, Ohio. The stem cells come from the bone marrow of healthy donors and they're transformed in a New Jersey laboratory into cells similar to brain neurons. Patients taking part in the trial at Erlanger receive a dose of up to 1.2 billion stem cells, which comes in a single bag and looks like a bag of brownish-colored blood plasma. Six people have chosen to have the stem cells injected at Erlanger — which doesn't cost them anything, since Athersys pays for it.
"It's like 'why not?'" said Katrina Barton, the certified clinical research coordinator who helps Devlin oversee the study. "We've seen some results that have been very impressive. The thing that's impressed me the most is the improvement at day 30."
Erlanger will get to see the final results of the trial when it is presented at the International Stroke Conference in Nashville in February
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Post by sethd023 on Jan 11, 2015 16:14:50 GMT
Some key excerpts below. Bolding is mine.
They go on to say that its a double blind trial, so they don't know if the improvements they're seeing at day 30 are from patients getting Multistem or the placebo, but my guess is that the patients seeing improvement at day 30 are the ones getting Multistem, because the entry criteria for this trial is structured to identify and weed out/exclude patients that are more likely to recover on their own.
With regard to seeing results in February at that conference, it'd be interesting to know the author's source of that information. IMO, they could announce some type of top line data in February, and then more complete results later on. Until I get more confirmation direcly from the company, I'm still going to assume we'll see results in late March early April. (The market may not make that same assumption based on this article.) ____________________
For almost three years now, stroke victims at Erlanger's clinic who meet certain criteria can have stem cell treatment through a study funded by Athersys Inc., of Cleveland, Ohio. The stem cells come from the bone marrow of healthy donors and they're transformed in a New Jersey laboratory into cells similar to brain neurons. Patients taking part in the trial at Erlanger receive a dose of up to 1.2 billion stem cells, which comes in a single bag and looks like a bag of brownish-colored blood plasma. Six people have chosen to have the stem cells injected at Erlanger — which doesn't cost them anything, since Athersys pays for it.
"It's like 'why not?'" said Katrina Barton, the certified clinical research coordinator who helps Devlin oversee the study. "We've seen some results that have been very impressive. The thing that's impressed me the most is the improvement at day 30."
Erlanger will get to see the final results of the trial when it is presented at the International Stroke Conference in Nashville in February
I actually had to read through that part a few times myself, and I came away thinking that the author meant the clot-grabbing procedure results will be announced in February because of the section bolded below (which refers to techniques and devices instead of stem cells). And that, as you speculated, we'll see results sometime around late Q1. "Erlanger will get to see the final results of the trial when it is presented at the International Stroke Conference in Nashville in February. There are many possible implications from the positive trials, the Erlanger doctors say. But the key one is that "there will be no more question as to whether intervention works," said Devlin. Such agreement in the medical field, he said, will mean that the techniques doctors at Erlanger have been using for years will become a technically FDA-approved treatment, and the agency may start relabeling devices specifically for stroke."
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Post by JHam on Jan 12, 2015 3:05:10 GMT
Some key excerpts below. Bolding is mine.
They go on to say that its a double blind trial, so they don't know if the improvements they're seeing at day 30 are from patients getting Multistem or the placebo, but my guess is that the patients seeing improvement at day 30 are the ones getting Multistem, because the entry criteria for this trial is structured to identify and weed out/exclude patients that are more likely to recover on their own.
With regard to seeing results in February at that conference, it'd be interesting to know the author's source of that information. IMO, they could announce some type of top line data in February, and then more complete results later on. Until I get more confirmation direcly from the company, I'm still going to assume we'll see results in late March early April. (The market may not make that same assumption based on this article.) ____________________
For almost three years now, stroke victims at Erlanger's clinic who meet certain criteria can have stem cell treatment through a study funded by Athersys Inc., of Cleveland, Ohio. The stem cells come from the bone marrow of healthy donors and they're transformed in a New Jersey laboratory into cells similar to brain neurons. Patients taking part in the trial at Erlanger receive a dose of up to 1.2 billion stem cells, which comes in a single bag and looks like a bag of brownish-colored blood plasma. Six people have chosen to have the stem cells injected at Erlanger — which doesn't cost them anything, since Athersys pays for it.
"It's like 'why not?'" said Katrina Barton, the certified clinical research coordinator who helps Devlin oversee the study. "We've seen some results that have been very impressive. The thing that's impressed me the most is the improvement at day 30."
Erlanger will get to see the final results of the trial when it is presented at the International Stroke Conference in Nashville in February
Very interesting and potentially exciting article. Thanks for finding and posting Seth! Jckrdu, I agree. Even if they do not know who exactly is getting the stem cell treatment, her excitement shows that they are seeing results beyond what they are used to seeing. If the only difference between the normal procedure they do at the center and the procedure done in the ATHX trial is stem cells, then what else could be responsible for the "impressive" improvement results at day 30?
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Post by JHam on Jan 12, 2015 3:12:24 GMT
Some key excerpts below. Bolding is mine.
They go on to say that its a double blind trial, so they don't know if the improvements they're seeing at day 30 are from patients getting Multistem or the placebo, but my guess is that the patients seeing improvement at day 30 are the ones getting Multistem, because the entry criteria for this trial is structured to identify and weed out/exclude patients that are more likely to recover on their own.
With regard to seeing results in February at that conference, it'd be interesting to know the author's source of that information. IMO, they could announce some type of top line data in February, and then more complete results later on. Until I get more confirmation direcly from the company, I'm still going to assume we'll see results in late March early April. (The market may not make that same assumption based on this article.) ____________________
For almost three years now, stroke victims at Erlanger's clinic who meet certain criteria can have stem cell treatment through a study funded by Athersys Inc., of Cleveland, Ohio. The stem cells come from the bone marrow of healthy donors and they're transformed in a New Jersey laboratory into cells similar to brain neurons. Patients taking part in the trial at Erlanger receive a dose of up to 1.2 billion stem cells, which comes in a single bag and looks like a bag of brownish-colored blood plasma. Six people have chosen to have the stem cells injected at Erlanger — which doesn't cost them anything, since Athersys pays for it.
"It's like 'why not?'" said Katrina Barton, the certified clinical research coordinator who helps Devlin oversee the study. "We've seen some results that have been very impressive. The thing that's impressed me the most is the improvement at day 30."
Erlanger will get to see the final results of the trial when it is presented at the International Stroke Conference in Nashville in February
I actually had to read through that part a few times myself, and I came away thinking that the author meant the clot-grabbing procedure results will be announced in February because of the section bolded below (which refers to techniques and devices instead of stem cells). And that, as you speculated, we'll see results sometime around late Q1. "Erlanger will get to see the final results of the trial when it is presented at the International Stroke Conference in Nashville in February. There are many possible implications from the positive trials, the Erlanger doctors say. But the key one is that "there will be no more question as to whether intervention works," said Devlin. Such agreement in the medical field, he said, will mean that the techniques doctors at Erlanger have been using for years will become a technically FDA-approved treatment, and the agency may start relabeling devices specifically for stroke." Tough to tell, but it would be strange for them to present data at this conference in February when we were guided recently that we would not get it late Q1. I am with you guys that I think that the author could be confusing things. Here is the link to the conference. No abstracts posted yet, nor list of presenters that I can tell: my.americanheart.org/professional/Sessions/InternationalStrokeConference/International-Stroke-Conference_UCM_316901_SubHomePage.jsp
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Post by JHam on Jan 12, 2015 4:35:46 GMT
Some key excerpts below. Bolding is mine.
They go on to say that its a double blind trial, so they don't know if the improvements they're seeing at day 30 are from patients getting Multistem or the placebo, but my guess is that the patients seeing improvement at day 30 are the ones getting Multistem, because the entry criteria for this trial is structured to identify and weed out/exclude patients that are more likely to recover on their own.
With regard to seeing results in February at that conference, it'd be interesting to know the author's source of that information. IMO, they could announce some type of top line data in February, and then more complete results later on. Until I get more confirmation direcly from the company, I'm still going to assume we'll see results in late March early April. (The market may not make that same assumption based on this article.) ____________________
For almost three years now, stroke victims at Erlanger's clinic who meet certain criteria can have stem cell treatment through a study funded by Athersys Inc., of Cleveland, Ohio. The stem cells come from the bone marrow of healthy donors and they're transformed in a New Jersey laboratory into cells similar to brain neurons. Patients taking part in the trial at Erlanger receive a dose of up to 1.2 billion stem cells, which comes in a single bag and looks like a bag of brownish-colored blood plasma. Six people have chosen to have the stem cells injected at Erlanger — which doesn't cost them anything, since Athersys pays for it.
"It's like 'why not?'" said Katrina Barton, the certified clinical research coordinator who helps Devlin oversee the study. "We've seen some results that have been very impressive. The thing that's impressed me the most is the improvement at day 30."
Erlanger will get to see the final results of the trial when it is presented at the International Stroke Conference in Nashville in February
Very interesting and potentially exciting article. Thanks for finding and posting Seth! Jckrdu, I agree. Even if they do not know who exactly is getting the stem cell treatment, her excitement shows that they are seeing results beyond what they are used to seeing. If the only difference between the normal procedure they do at the center and the procedure done in the ATHX trial is stem cells, then what else could be responsible for the "impressive" improvement results at day 30? Opps, my above post should have read: "If the only difference between the normal procedure they do at the center and the procedure done in the ATHX trial *is stem cells*, then what else could be responsible for the "impressive" improvement results at day 30?"
Sorry for the sloppiness.
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Post by RLC on Jan 12, 2015 4:39:11 GMT
Ya the author didn't make this very clear, but he refers to the other trial saying "The study will not be published until next month." (Next month being February). Then in the "Implications" section he says they won't get to see the final results of the trial until February, so I think it's safe to assume he wasn't refering to the Athersy's trial. I'm with everyone else that we should keep expectations on ATHX releasing towards the end of Q1.
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Post by selluwud on Jan 12, 2015 13:28:07 GMT
Nice little pop pre-market this AM. Move back up today?? Jckrdu, did you influence the market??
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Post by jckrdu on Jan 12, 2015 14:17:17 GMT
Nice little pop pre-market this AM. Move back up today?? Jckrdu, did you influence the market?? Yeah, that article is getting circulated. Very positive quote about them seeing positive results at 30 days - even if it is a double blinded trial - as there has been very little information disclosed over the past 3 years about trial participants. IMO, that article will give some folks on the fence more of a reason to buy.
Presentation at the Biotech conference is tomorrow. Combination of those 2 events hopefully means we hold the recent gains and consolidate over $1.80, or maybe move higher. I plan to continue to accumulate under $2.
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Post by Yelk on Jan 12, 2015 21:26:28 GMT
Good run today! Still at a negative position as I bought in at $2 (silly) but nice to see strength today. Anticipation of tomorrow I presume and obvious larger catalysts.
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Post by JHam on Jan 12, 2015 22:59:39 GMT
Doubled my position today at $1.91. New average is $1.81 and have cash on the side if it goes below that.
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