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Post by jckrdu on Jan 26, 2015 19:45:31 GMT
- UC Phase 2b announced with Pfizer - Partnership in Japan for stroke - AMI start of Phase 2 - GVHD start of pivotal Phase 2/3 with a partner funding the trials - etc
Other than the AMI P2 start, I'd say all bets are off. Those announcements would mean there is proof of Multi Stem working and commitments are being made. Hold for profit multiples. Agree....
Gil has stated that GVHD will be done with a partner, so that news is coming.... just don't know when. Pretty good efficacy seen in the Phase 1 GVHD trial.
On whether or not ATHX partners in Japan before or after results, I'd flip a coin. Part of me sees both ATHX and their Japanese partner both being motivated to strike a deal before results are announced; ATHX because it'd be a good way to hedge against poor/lukewarm results.... and the Japanese partner because if results are good they'll pay a lot more to partner after good results are out.
We'll see. Lots of news could hit in the next 60 days to get this considerably higher before stroke results.
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Post by jckrdu on Jan 26, 2015 21:17:25 GMT
Another great day up 7% on 2.1 million shares... three times the average volume. Broke out of the recent trading range as the chart was telling us it would for 3 days last week. Accumulation in progress prior to results.
The still very favorable risk/reward ratio should keep buying pressure steady. We'll see profit taking as it continues to move higher, as we did today.
Good to see support at $2.15 hold today. It tried to take out the next resistance level of $2.30ish, but stalled at $2.27. May need to consolidate a bit more before pushing higher. Given today's volume, good chance IMO we move past $2.30ish sometime this week.
GLTA.
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Post by jckrdu on Jan 27, 2015 13:29:56 GMT
A good day. Tested the recent low at $1.78, and then gradually moved up.
Nice to see it close near the high of the day on another late day volume surge into the close. Consolidation at current levels is setting ATHX up good for the next leg up.
Good 3 day weekend all.
Take a look at the ATHX 3 month chart. For those that are interested in technical analysis (TA), it looks to me like a pretty clear flag or pennant pattern is forming. Below is some more information. Bolding is mine. With regard to the last paragraph below, ATHX's prior move was from let's say $1.30 to $2.00. If future trading does follow the typical flag pattern, a .70 increase (the distance of the prior move) from here ($1.80-ish) would be the target price sometime relatively soon after the breakout we're hoping to see. GLTA.
_____________________________________
The flag and pennant patterns are two continuation patterns that closely resemble each other, differing only in their shape during the pattern's consolidation period. This is the reason the terms flag and pennant are often used interchangeably. A flag is a rectangular shape, while the pennant looks more like a triangle.
These two patterns are formed when there is a sharp price movement followed by generally sideways price movement, which is the flag or pennant. The pattern is complete when there is a price breakout in the same direction of the initial sharp price movement. The following move will see a similarly sharp move in the same direction as the prior sharp move. The complete move of the chart pattern - from the first sharp move to the last sharp move - is referred to as the flag pole.
The flag or pennant is considered to be flying at half-mast, as the distance of the initial price movement is thought to be roughly equal to the proceeding price move. The reason these patterns form is that after a large price movement, the market consolidates, or pauses, before resuming the initial trend.
The Flag
The flag pattern forms what looks like a rectangle. The rectangle is formed by two parallel trendlines that act as support and resistance for the price until the price breaks out. In general, the flag will not be perfectly flat but will have its trendlines sloping.
In general, the slope of the flag should move in the opposite direction of the initial sharp price movement; so if the initial movement were up, the flag should be downward sloping.
The buy or sell signal is formed once the price breaks through the support or resistance level, with the trend continuing in the prior direction. This breakthrough should be on heavier volume to improve the signal of the chart pattern.
While the construct of the pause in the trend is different for the flag and pennant, the attributes of the chart patterns themselves are similar. It is vital that the price movement prior to the flag or pennant be a strong, sharp move.
The volume, as with most breakout signals, should be seen as strong during the breakout to confirm the signal. Upon breakout, the initial price objective is equal to the distance of the prior move added to the breakout point. For example, if a prior sharp up movement was from $30 to $40, then the resulting price objective from a price breakout of $38 would be $48 ($38+$10).
www.investopedia.com/university/charts/charts6.asp
I'm bumping this post from a few weeks ago when ATHX was consolidating, as its relevant now....
The distance of the "prior move" was in the .50 to .70 cent range. Now that ATHX has broken out as expected, if ATHX follows the typical flag pattern, we should see a similar fast .50 to .70 cent range move from the break out price. ATHX broke out from around $2.00, which means - from a technical analysis perspective - the charts are point to relatively quick move up to the $2.50 to $2.70 range.
Nothing is certain of course - especially with selling pressure rising as the pps moves higher, but the chart is setting up nicely.... and is one reason why I'll continue to hold at least until we start trading over that $2.70 gap.
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Post by Yelk on Jan 27, 2015 14:57:15 GMT
Thanks for the insight Jckrdu! Great post. I wonder if we won't see much upside with DJ getting nailed today. Volume pretty weak today.
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Post by jckrdu on Jan 27, 2015 15:05:47 GMT
Thanks for the insight Jckrdu! Great post. I wonder if we won't see much upside with DJ getting nailed today. Volume pretty weak today. Thanks Yelk. Holding $2.15 will be bullish, even if we don't see another big move up today. |
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Post by jckrdu on Jan 27, 2015 15:45:56 GMT
Thanks for the insight Jckrdu! Great post. I wonder if we won't see much upside with DJ getting nailed today. Volume pretty weak today. Thanks Yelk. Holding $2.15 will be bullish, even if we don't see another big move up today. It broke under $2.15. We could see a brief re-test of the 5 day moving average at $2.06. If it does move lower (not saying it will), support at $2.06 looks pretty strong so I don't see it trading below that level. Any retest of the 5 DMA - if it does happen - will be brief, IMO.
Will be in meetings the rest of the day. GL all.
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Post by jckrdu on Jan 27, 2015 18:45:47 GMT
Thanks for the insight Jckrdu! Great post. I wonder if we won't see much upside with DJ getting nailed today. Volume pretty weak today. Thanks Yelk. Holding $2.15 will be bullish, even if we don't see another big move up today. After a brief test below support at $2.15, volume is now picking up. Looks like it wants to take another run at $2.30 today. Sounds good to me.  |
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Post by jckrdu on Jan 28, 2015 3:49:18 GMT
Thanks Yelk. Holding $2.15 will be bullish, even if we don't see another big move up today. After a brief test below support at $2.15, volume is now picking up. Looks like it wants to take another run at $2.30 today. Sounds good to me. Another strong day. Average daily volume over the last 3 months is about 500k shares a day. Today's volume was almost twice that, so accumulation continues. I don't see this accumulation slowing down until ATHX gets up to at least $3ish, which could come fairly soon.
IMO, the risk/reward opportunity at the current low pps is driving the volume and move higher: At a pps of $2, ATHX will - IMO - be on a path to be an easy 10 bagger if they announce any kind of positive stroke results. With 77 million shares issued, a $20 pps (10 bagger from $2) would be a market CAP of only about $1.5B... which IMO is pretty low for a company on the verge of generating significant revenue.... again, all on the assumption of positive stroke results.
With any type of efficacy signal seen in the Phase 2 stroke trial, the other dominos are almost certain to fall as ATHX has been laying the groundwork in Japan for close to 2 years, and the Japanese gov't wants another treatment for stroke beyond tpa. Those other dominos that IMO would be near certain to fall include: 1) announcement of a Japanese partner that ATHX will use to go to market with Multistem for stroke in Japan, and who they'll also partner with to fund/help execute the parallel trial for testing Multistem in Japanese patients, 2) announcement that ATHX has applied for conditional approval for stroke in Japan, and soon after the news that IMO will take it to a $20+ pps... 3) announcement that Multistem was granted conditional approval to treat stroke in Japan at approximately $25,000 per treatment.
All the groundwork has been laid by the company over the past 3 years. News of a positive efficacy signal from the Phase 2 trials in about 8 weeks could set it all in motion. Doesn't get any more exciting than this for us biotech investors.
Good luck to those holding now, and all those who intend to hold through results.
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Post by Yelk on Jan 28, 2015 4:03:31 GMT
After a brief test below support at $2.15, volume is now picking up. Looks like it wants to take another run at $2.30 today. Sounds good to me. Another strong day. Average daily volume over the last 3 months is about 500k shares a day. Today's volume was almost twice that, so accumulation continues. I don't see this accumulation slowing down until ATHX gets up to at least $3ish, which could come fairly soon.
IMO, the risk/reward opportunity at the current low pps is driving the volume and move higher: At a pps of $2, ATHX will - IMO - be on a path to be an easy 10 bagger if they announce any kind of positive stroke results. With 77 million shares issued, a $20 pps (10 bagger from $2) would be a market CAP of only about $1.5B... which IMO is pretty low for a company on the verge of generating significant revenue.... again, all on the assumption of positive stroke results.
With any type of efficacy signal seen in the Phase 2 stroke trial, the other dominos are almost certain to fall as ATHX has been laying the groundwork in Japan for close to 2 years, and the Japanese gov't wants another treatment for stroke beyond tpa. Those other dominos that IMO would be near certain to fall include: 1) announcement of a Japanese partner that ATHX will use to go to market with Multistem for stroke in Japan, and who they'll also partner with to fund/help execute the parallel trial for testing Multistem in Japanese patients, 2) announcement that ATHX has applied for conditional approval for stroke in Japan, and soon after the news that IMO will take it to a $20+ pps... 3) announcement that Multistem was granted conditional approval to treat stroke in Japan at approximately $25,000 per treatment.
All the groundwork has been laid by the company over the past 3 years. News of a positive efficacy signal from the Phase 2 trials in about 8 weeks could set it all in motion. Doesn't get any more exciting than this for us biotech investors.
Good luck to those holding now, and all those who intend to hold through results.
Great post again Jckrdu! It seems all the dominoes (I didn't mean to steal that didn't notice you used this analogy until I posted  are lined up for either a big win or lose. I am extremely optimistic about the run-up but I'm sure like most investors out there while we enjoy the thought of the 10 bagger I would say this is considerable risk to leave a large amount in through results. Either way I figure as I got in around $1.84-$1.90 if this makes it above $3 I will leave mostly all of it in and subtract profits. I think for this catalyst I am willing to risk short term profits for this upside as it is pretty much an investors dream seems a small sacrifice. Just imo though. Tomorrow should be an interesting day I am feeling it is going to go strong one way or the other  . |
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Post by jckrdu on Jan 28, 2015 4:19:18 GMT
Another strong day. Average daily volume over the last 3 months is about 500k shares a day. Today's volume was almost twice that, so accumulation continues. I don't see this accumulation slowing down until ATHX gets up to at least $3ish, which could come fairly soon.
IMO, the risk/reward opportunity at the current low pps is driving the volume and move higher: At a pps of $2, ATHX will - IMO - be on a path to be an easy 10 bagger if they announce any kind of positive stroke results. With 77 million shares issued, a $20 pps (10 bagger from $2) would be a market CAP of only about $1.5B... which IMO is pretty low for a company on the verge of generating significant revenue.... again, all on the assumption of positive stroke results.
With any type of efficacy signal seen in the Phase 2 stroke trial, the other dominos are almost certain to fall as ATHX has been laying the groundwork in Japan for close to 2 years, and the Japanese gov't wants another treatment for stroke beyond tpa. Those other dominos that IMO would be near certain to fall include: 1) announcement of a Japanese partner that ATHX will use to go to market with Multistem for stroke in Japan, and who they'll also partner with to fund/help execute the parallel trial for testing Multistem in Japanese patients, 2) announcement that ATHX has applied for conditional approval for stroke in Japan, and soon after the news that IMO will take it to a $20+ pps... 3) announcement that Multistem was granted conditional approval to treat stroke in Japan at approximately $25,000 per treatment.
All the groundwork has been laid by the company over the past 3 years. News of a positive efficacy signal from the Phase 2 trials in about 8 weeks could set it all in motion. Doesn't get any more exciting than this for us biotech investors.
Good luck to those holding now, and all those who intend to hold through results.
Great post again Jckrdu! It seems all the dominoes (I didn't mean to steal that didn't notice you used this analogy until I posted are lined up for either a big win or lose. I am extremely optimistic about the run-up but I'm sure like most investors out there while we enjoy the thought of the 10 bagger I would say this is considerable risk to leave a large amount in through results. Either way I figure as I got in around $1.84-$1.90 if this makes it above $3 I will leave mostly all of it in and subtract profits. I think for this catalyst I am willing to risk short term profits for this upside as it is pretty much an investors dream seems a small sacrifice. Just imo though. Tomorrow should be an interesting day I am feeling it is going to go strong one way or the other . Thanks Yelk and agree...high risk, high reward. We'll all have lots to ponder regarding how much to keep invested before results are announced. No easy answers, except to say that staying 100% invested is probably not a wise move.
A few factors and some more thoughts on things I'll be looking at over the coming 8 weeks....
- The extent of the pre-results run-up will be a factor that determines how much I keep invested thru results. If we hang around in the $2s over the next 8 weeks (that's possible) I'm likely to keep more invested thru results as the market (at a $2ish pps) will be saying that it expects results to be poor. Any kind of efficacy signal announced would then be an upside surprise and the pps would rally.
- Likewise, if the pps gets up into the $4-$6 range before results (also possible) I'll likely take more off the table, because if an efficacy signal is announced in results, it may not be "good enough" in the markets eyes, and ATHX could actually retrace initially after positive results.
- The risk of poor results is somewhat mitigated as IMO the worst case scenario (no statistically significant efficacy signal) will be that ATHX will still execute and announce a partnership with a Japanese partner that will fund a pivotal trial in stroke in Japan using a modified trial protocol based upon what was learned in the US Phase 2 trial. So, I plan to have some cash available to buy if we see an immediate and drastic pullback on poor results, because I still believe the Japanese partnership/pivotal trial news will be coming soon afterwards, which will help the pps recover.
Lots to think about.
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Post by Yelk on Jan 28, 2015 4:36:38 GMT
Great post again Jckrdu! It seems all the dominoes (I didn't mean to steal that didn't notice you used this analogy until I posted are lined up for either a big win or lose. I am extremely optimistic about the run-up but I'm sure like most investors out there while we enjoy the thought of the 10 bagger I would say this is considerable risk to leave a large amount in through results. Either way I figure as I got in around $1.84-$1.90 if this makes it above $3 I will leave mostly all of it in and subtract profits. I think for this catalyst I am willing to risk short term profits for this upside as it is pretty much an investors dream seems a small sacrifice. Just imo though. Tomorrow should be an interesting day I am feeling it is going to go strong one way or the other . Agree Yelk, high risk... high reward. We'll all have lots to ponder regarding how much to keep invested before results are announced. No easy answers, except to say that staying 100% invested is probably not a wise move.
A few factors and some more thoughts on things I'll be looking at over the coming 8 weeks....
- The extent of the pre-results run-up will be a factor that determines how much I keep invested thru results. If we hang around in the $2s over the next 8 weeks (that's possible) I'm likely to keep more invested thru results as the market (at a $2ish pps) will be saying that it expects results to be poor. Any kind of efficacy signal announced would then be an upside surprise and the pps would rally.
- Likewise, if the pps gets up into the $4-$6 range before results (also possible) I'll likely take more off the table, because if an efficacy signal is announced in results, it may not be "good enough" in the markets eyes, and ATHX could actually retrace initially after positive results.
- The risk of poor results is somewhat mitigated as IMO the worst case scenario (no statistically significant efficacy signal) will be that ATHX will still execute and announce a partnership with a Japanese partner that will fund a pivotal trial in stroke in Japan using a modified trial protocol based upon what was learned in the US Phase 2 trial. So, I plan to have some cash available to buy if we see an immediate and drastic pullback on poor results, because I still believe the Japanese partnership/pivotal trial news will be coming soon afterwards, which will help the pps recover.
Lots to think about.
To clarify you think there may be a middle ground that the data doesn't justify easy path to next phase in U.S. but may be sufficient for work in Japan? Interesting angle I never even considered. We also have to keep in mind this isn't the only catalyst as well so if the PPS completely tanks on mediocre results I agree could be an interesting buy in. There are so many companies with catalysts in the next 8-10 weeks - this is going to be one crazy break into spring... |
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Post by jckrdu on Jan 28, 2015 4:48:26 GMT
Agree Yelk, high risk... high reward. We'll all have lots to ponder regarding how much to keep invested before results are announced. No easy answers, except to say that staying 100% invested is probably not a wise move.
A few factors and some more thoughts on things I'll be looking at over the coming 8 weeks....
- The extent of the pre-results run-up will be a factor that determines how much I keep invested thru results. If we hang around in the $2s over the next 8 weeks (that's possible) I'm likely to keep more invested thru results as the market (at a $2ish pps) will be saying that it expects results to be poor. Any kind of efficacy signal announced would then be an upside surprise and the pps would rally.
- Likewise, if the pps gets up into the $4-$6 range before results (also possible) I'll likely take more off the table, because if an efficacy signal is announced in results, it may not be "good enough" in the markets eyes, and ATHX could actually retrace initially after positive results.
- The risk of poor results is somewhat mitigated as IMO the worst case scenario (no statistically significant efficacy signal) will be that ATHX will still execute and announce a partnership with a Japanese partner that will fund a pivotal trial in stroke in Japan using a modified trial protocol based upon what was learned in the US Phase 2 trial. So, I plan to have some cash available to buy if we see an immediate and drastic pullback on poor results, because I still believe the Japanese partnership/pivotal trial news will be coming soon afterwards, which will help the pps recover.
Lots to think about.
To clarify you think there may be a middle ground that the data doesn't justify easy path to next phase in U.S. but may be sufficient for work in Japan? Interesting angle I never even considered. We also have to keep in mind this isn't the only catalyst as well so if the PPS completely tanks on mediocre results I agree could be an interesting buy in. There are so many companies with catalysts in the next 8-10 weeks - this is going to be one crazy break into spring... Yes, in Japan the rules for conditional approval to start selling is that the product has to show safety and "probable efficacy". IMO, there's some wiggle room in there to define and claim that the "probable efficacy" threshold was met in Japan.
ATHX spent a lot of time looking at reimbursement in Japan (with Japanese consultants who specialize in that field) which resulted in ATHX modifying the Phase 1 and 2 trial endpoints, so that the results will better map to and support the reimbursements ATHX will be looking for with the treatment. Long story short (listen to Gil's last presentation) they don't need to meet ALL the endpoints to meet the "probable efficacy" threshold.
Signing off for the night. Will check back in the AM.
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Post by JHam on Jan 28, 2015 5:41:09 GMT
After a brief test below support at $2.15, volume is now picking up. Looks like it wants to take another run at $2.30 today. Sounds good to me. Another strong day. Average daily volume over the last 3 months is about 500k shares a day. Today's volume was almost twice that, so accumulation continues. I don't see this accumulation slowing down until ATHX gets up to at least $3ish, which could come fairly soon.
IMO, the risk/reward opportunity at the current low pps is driving the volume and move higher: At a pps of $2, ATHX will - IMO - be on a path to be an easy 10 bagger if they announce any kind of positive stroke results. With 77 million shares issued, a $20 pps (10 bagger from $2) would be a market CAP of only about $1.5B... which IMO is pretty low for a company on the verge of generating significant revenue.... again, all on the assumption of positive stroke results.
With any type of efficacy signal seen in the Phase 2 stroke trial, the other dominos are almost certain to fall as ATHX has been laying the groundwork in Japan for close to 2 years, and the Japanese gov't wants another treatment for stroke beyond tpa. Those other dominos that IMO would be near certain to fall include: 1) announcement of a Japanese partner that ATHX will use to go to market with Multistem for stroke in Japan, and who they'll also partner with to fund/help execute the parallel trial for testing Multistem in Japanese patients, 2) announcement that ATHX has applied for conditional approval for stroke in Japan, and soon after the news that IMO will take it to a $20+ pps... 3) announcement that Multistem was granted conditional approval to treat stroke in Japan at approximately $25,000 per treatment.
All the groundwork has been laid by the company over the past 3 years. News of a positive efficacy signal from the Phase 2 trials in about 8 weeks could set it all in motion. Doesn't get any more exciting than this for us biotech investors.
Good luck to those holding now, and all those who intend to hold through results.
Jckrdu, Nice post. I read this over twice in my head like a romance novel narrated by Leslie Nielsen (with that deep romantic voice from his romance movies) Seriously though, I am not sure if a $1.5B will be achieved overnight, but what I do feel confident about is that if the stroke data is positive the risk/reward will be about as good as you can get in my opinion. |
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Post by forthefuture on Jan 28, 2015 6:13:35 GMT
I've been wondering the same thing... and here are my brief thoughts... - Other news surrounding the UC runup that could have assisted to the Q1 2014 rally
-ATHX received Orphan Designation in Europe for GVHD (PR on 12/17/2013)
-ATHX confirmed completion of Patient Enrollment for Phase 2 UC Study, indicated results are expected in Q2 2014 (PR on 12/19/2013)
-ATHX announces new patents in Japan for Stem Cell & Regen Medicine Tech (PR on 01/09/2014)
-ATHX prices offering of common stock. Closed the deal @ $4.10/share (including warrants) for proceeds of $20.5 million (PR on 01/10/2014)
**Results of UC data released on 04/28/2014
Also keep the following items in mind:
- UC trial failing to show significant efficacy could dampen the run up as people might feel MultiStem is not an effective product
- While the UC trial was a collaborative effort with Pfizer and would have likely brought revenues to ATHX much faster (IMO), the market potential for stroke is far greater than for UC and ATHX owns 100% of that program. And with Japan initiatives, it's possible that ATHX see's revenues much quicker than was ever possible in the past.
Good question Sell, and good points in response Day and RLC.
Upside on positive stroke results is much much higher than positive UC results would have generated, so many analysts are thinking ATHX will run back up to $4+ prior to stroke results. There's a lot of pretty good scientific pre-clinical data out there that says Multistem will have an impact on stoke patients. A run to the $4 or $6 range would not surprise me at all. That said.... I'm going to keep a conservative view and wait for $3ish and will then re-evaluate.
Also note that the run to $3ish I'm expecting at a minimum assumes no other news gets announced. What if ATHX announces any one of the following news items before stroke results are released?
- UC Phase 2b announced with Pfizer - Partnership in Japan for stroke - AMI start of Phase 2 - GVHD start of pivotal Phase 2/3 with a partner funding the trials - etc
Jck, do you have a link to the preclin results? FWIW, found this on cell therapies for stroke. One valid point (and I dont have the answer) is how closely or not rat models mimic human stroke heterogeneity. stroke.ahajournals.org/content/40/3_suppl_1/S146.full#ref-4 |
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Post by RLC on Jan 28, 2015 6:38:54 GMT
Good discussion guys. My view on an exit strategy is similar to Jckrdu's. I think the upside potential is large enough to justify holding a good amount through data release, however you'd be silly not to take some profits beforehand IMO (especially if you got in under $2).
I'm a little more concerned about the implications of the trial failing to prove statistically significant efficacy. That will be two separate Phase 2 trials using the same therapeutic agent, MultiStem (which happens to be the foundation and bulk of their research), failing to show efficacy. I can't see that boding well for shareholders. Jck could easily be right about them still being able to roll along in Japan, but even then you have to start to question management for their inability to design a trial capable of showing statistical significance. Also, I'm assuming they'll be raising cash sometime in the 2nd half of this year (not a certainty, but definitely something to keep in mind).
I'm going in under the worst-case assumption that ATHX could hit ~$1 if results are negative. With that being said, that's only a 30% loss for me from my cost basis. So with their being huge upside and relatively little downside potential (for me personally), I'm likely going to be keeping a fairly good amount in for the data release (25%+). However, if results are negative I'm planning on selling anything I've held onto at that point (assuming nothing else materializes).
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Post by JHam on Jan 28, 2015 9:27:30 GMT
Good discussion guys. My view on an exit strategy is similar to Jckrdu's. I think the upside potential is large enough to justify holding a good amount through data release, however you'd be silly not to take some profits beforehand IMO (especially if you got in under $2). I'm a little more concerned about the implications of the trial failing to prove statistically significant efficacy. That will be two separate Phase 2 trials using the same therapeutic agent, MultiStem (which happens to be the foundation and bulk of their research), failing to show efficacy. I can't see that boding well for shareholders. Jck could easily be right about them still being able to roll along in Japan, but even then you have to start to question management for their inability to design a trial capable of showing statistical significance. Also, I'm assuming they'll be raising cash sometime in the 2nd half of this year (not a certainty, but definitely something to keep in mind). I'm going in under the worst-case assumption that ATHX could hit ~$1 if results are negative. With that being said, that's only a 30% loss for me from my cost basis. So with their being huge upside and relatively little downside potential (for me personally), I'm likely going to be keeping a fairly good amount in for the data release (25%+). However, if results are negative I'm planning on selling anything I've held onto at that point (assuming nothing else materializes). RLC, Good thoughts. If ATHX fails for a 2nd time to produce positive results with their lead program, then I think you can stick a fork in them. They'll have to show at least some hint of clinical benefit in my opinion for them to be considered for conditional approval in Japan. The good news is that based on the pre-clinical data I have read, I feel they will show promising P2 results. The company sure seems 100% confident that they will produce good results by the way they are acting over the past few months (i.e. the way they talk at presentations, on conference calls, and have been going after Japan so aggressively). Even though this is a double blind placebo controlled trial where they can't see any data until the end, they could be hearing hints of information from trial sites. Being blind to the data doesn't mean they are blind to conversation does it? It's not hard to imagine patients or families of patients and maybe even trial doctors expressing some kind of satisfaction (or dissatisfaction) after a treatment was done. For example: Gil: Hey [trial investigator]! Just wanted to call and see how enrollment is going. Investigator: So far so good Gil. We enrolled two new patients last week. Gil: OK great! Investigator: Incidentally you should have seen it. One of those guys honestly should have been dead, but he walked out of here under his own power 4 days after treatment. Pretty interesting stuff. Just look at how that article a few weeks ago stated that they are seeing exciting results and you can imagine that it is easy for someone close to the trial to share their opinion. I seriously doubt that article was the first time Gil had heard anything like that about the trial. With something like stroke it is easy to see marked improvement in someone with the naked eye, without seeing data. Anyhoo, if they fail to meet endpoints in this trial it would be a monumental disappointment. I know Gil was just as "enthusiastic" about the UC trial prior to results. But again if you read the data to this point, it is easy to see why Multistem has a better chance working in stroke over UC. That said, I too will probably be shaving some off the top if we are high enough prior to stroke data. |
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Post by jckrdu on Jan 28, 2015 12:33:41 GMT
Another strong day. Average daily volume over the last 3 months is about 500k shares a day. Today's volume was almost twice that, so accumulation continues. I don't see this accumulation slowing down until ATHX gets up to at least $3ish, which could come fairly soon.
IMO, the risk/reward opportunity at the current low pps is driving the volume and move higher: At a pps of $2, ATHX will - IMO - be on a path to be an easy 10 bagger if they announce any kind of positive stroke results. With 77 million shares issued, a $20 pps (10 bagger from $2) would be a market CAP of only about $1.5B... which IMO is pretty low for a company on the verge of generating significant revenue.... again, all on the assumption of positive stroke results.
With any type of efficacy signal seen in the Phase 2 stroke trial, the other dominos are almost certain to fall as ATHX has been laying the groundwork in Japan for close to 2 years, and the Japanese gov't wants another treatment for stroke beyond tpa. Those other dominos that IMO would be near certain to fall include: 1) announcement of a Japanese partner that ATHX will use to go to market with Multistem for stroke in Japan, and who they'll also partner with to fund/help execute the parallel trial for testing Multistem in Japanese patients, 2) announcement that ATHX has applied for conditional approval for stroke in Japan, and soon after the news that IMO will take it to a $20+ pps... 3) announcement that Multistem was granted conditional approval to treat stroke in Japan at approximately $25,000 per treatment.
All the groundwork has been laid by the company over the past 3 years. News of a positive efficacy signal from the Phase 2 trials in about 8 weeks could set it all in motion. Doesn't get any more exciting than this for us biotech investors.
Good luck to those holding now, and all those who intend to hold through results.
Jckrdu, Nice post. I read this over twice in my head like a romance novel narrated by Leslie Nielsen (with that deep romantic voice from his romance movies) Seriously though, I am not sure if a $1.5B will be achieved overnight, but what I do feel confident about is that if the stroke data is positive the risk/reward will be about as good as you can get in my opinion. Agree JHam, I'm not expecting to see a $1.5B market cap "overnight"... i.e. the first few days/weeks after positive stroke results are announced, but I do believe the news of the 3rd domino falling (conditional approval granted) perhaps within 6 months after positive results are announced will take ATHX to that $1.5B level and IMO likely beyond... as the market will start to factor in success of their other Phase 2/3 programs which should be underway by that time. |
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Post by Yelk on Jan 28, 2015 13:06:12 GMT
I haven't done much number crunching/models etc for biotech companies when they start to earn revenue. What is the ball park for ATHX if results show good enough efficacy for outside of Japan (long term) revenue. Somehow I feel that would be a whole lot more than a $20 PPS... But that is a very interesting conversation that will be continued if by some miracle the results are that good. I don't mean to pump but the potential is pretty huge. I am remaining as pessimistic as I can about the results as I can at the moment so I can make unemotional decisions at data time and mitigate losses If this does play out however will be a long road of interesting times ahead. |
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Post by jckrdu on Jan 28, 2015 13:11:39 GMT
Good question Sell, and good points in response Day and RLC.
Upside on positive stroke results is much much higher than positive UC results would have generated, so many analysts are thinking ATHX will run back up to $4+ prior to stroke results. There's a lot of pretty good scientific pre-clinical data out there that says Multistem will have an impact on stoke patients. A run to the $4 or $6 range would not surprise me at all. That said.... I'm going to keep a conservative view and wait for $3ish and will then re-evaluate.
Also note that the run to $3ish I'm expecting at a minimum assumes no other news gets announced. What if ATHX announces any one of the following news items before stroke results are released?
- UC Phase 2b announced with Pfizer - Partnership in Japan for stroke - AMI start of Phase 2 - GVHD start of pivotal Phase 2/3 with a partner funding the trials - etc
Jck, do you have a link to the preclin results? FWIW, found this on cell therapies for stroke. One valid point (and I dont have the answer) is how closely or not rat models mimic human stroke heterogeneity. stroke.ahajournals.org/content/40/3_suppl_1/S146.full#ref-4FTF - The "Media" tab on the Athersys website has the past "Press Releases" and "Relevant Publications" where one can find links and references within those PRs to the preclinical reports. I just went thru both those sections and posted the relevant information on stroke from past PRs and relevant publications. All of the below contain information on preclinical research done on stroke... I'm sure some will be more useful than others, but I'd spend some time scanning these and you should be able to find what you're looking for.
jck
Relevant Publications Mays RW, Borlongan CV, Yasuhara T et al.: Development of an allogeneic adherent stem cell therapy for treatment of ischemic stroke. J Exp Stroke Transl Med 3(1): 34-46 (2010) www.jestm.com/index.php/jestm/article/view/33
Walker PA, Bedi SS, Shah SK, Jimenez F, et al.: Intravenous multipotent adult progenitor cell therapy after traumatic brain injury: modulation of the resident microglia population. J Neuroinflammation. 2012 Sep 28;9:228. www.ncbi.nlm.nih.gov/pubmed/23020860
Stem Cell Therapies as an Emerging Paradigm in Stroke (STEPS): bridging basic and clinical science for cellular and neurogenic factor therapy in treating stroke. Stroke 40(2):510-5. (2009) www.ncbi.nlm.nih.gov/pubmed/19095993
Walker PA, Shah SK, Jimenez F, Gerber MH, Xue H, et al.: Intravenous multipotent adult progenitor cell therapy for traumatic brain injury: preserving the blood brain barrier via an interaction with splenocytes. Experimental Neurology 225:341–352 (2010) www.ncbi.nlm.nih.gov/pubmed/20637752
Yasuhara T, Hara K, Maki M, Mays RW et al.: Intravenous grafts recapitulate the neurorestoration afforded by intracerebrally delivered multipotent adult progenitor cells in neonatal hypoxic-ischemic rats. J Cereb Blood Flow Metab 28 (11):1804-10. (2008) www.ncbi.nlm.nih.gov/pubmed/18594556
Hess DC, and Borlongan CV. Cell-based therapy in ischemic stroke. Expert Rev Neurother (8): 1193–1201 (2008) www.ncbi.nlm.nih.gov/pubmed/18671663
Mays R, Van't Hof W, Deans R, et al. Development of adult pluripotent stem cell therapies for ischemic injury and disease. Expert Opin. Biol. Ther. 7(2):173-184 (2007) www.ncbi.nlm.nih.gov/pubmed/17250456
Yasuhara T, Matsukawa N, Yu G et al. Behavioral and histological characterization of intrahippocampal grafts of human bone marrow-derived multipotent progenitor cells in neonatal rats with hypoxic-ischemic injury. Cell Transplant. 2006 15(3):231-238. www.ncbi.nlm.nih.gov/pubmed/16719058
Other Relevant Papers: Iadecola C, Anrather J. The immunology of stroke: from mechanisms to translation. Nat Med 17(7):796-808 (2011)
PRs 2006 PR files.shareholder.com/downloads/ATHERSYS/3776303316x0x132042/C3C827D9-7D08-4294-A4FA-806819854A28/BVIC_News_2006_4_7_General_Releases.pdf
2010 PR on Multistem Impacts on Traumatic Brain Injury (methods of action in play for TBI are also in play for stroke) files.shareholder.com/downloads/ATHERSYS/3776303316x0x403917/61A84737-99FD-4575-ADE5-4AFCC25C305A/ATHX_News_2010_9_20_General_Releases.pdf
2011 PR on UT & Athersys Preclinical Data Showing Benefits of Multistem on Stroke files.shareholder.com/downloads/ATHERSYS/3776303316x0x440336/1AEF6312-9D4A-41CA-97AC-C649E01CB7D8/ATHX_News_2011_2_10_General_Releases.pdf
2012 PR On Multistem Impact on Traumatic Brain Injury, which includes stroke www.athersys.com/releasedetail.cfm?ReleaseID=712492
2013 PR With Links to Publications Showing Multistem relevance & methods of action on Auto-Immune, Vascular and Transplantation (This last one is not relevant to stroke, but it shows all the other indications that Athersys is working to target with Multistem.) www.athersys.com/releasedetail.cfm?ReleaseID=755617
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Post by jckrdu on Jan 28, 2015 13:45:02 GMT
I haven't done much number crunching/models etc for biotech companies when they start to earn revenue. What is the ball park for ATHX if results show good enough efficacy for outside of Japan (long term) revenue. Somehow I feel that would be a whole lot more than a $20 PPS... But that is a very interesting conversation that will be continued if by some miracle the results are that good. I don't mean to pump but the potential is pretty huge. I am remaining as pessimistic as I can about the results as I can at the moment so I can make unemotional decisions at data time and mitigate losses If this does play out however will be a long road of interesting times ahead. The "Wall Street Titan" did a good write up about a year ago on Seeking Alpha where he ballparked the ATHX pps on successful stroke data and market penetration. His analysis yielded a pps of over $300 per share in 2019 assuming a successful Phase 2 trial and some level of decent market penetration.... but only for North America and Japan.
So yes, upside is much higher than $20 on successful results. My $20 swag was just mentioned to show what I think is reasonable relatively soon (within 6 months) after any positive stroke results.
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are lined up for either a big win or lose. I am extremely optimistic about the run-up but I'm sure like most investors out there while we enjoy the thought of the 10 bagger I would say this is considerable risk to leave a large amount in through results. Either way I figure as I got in around $1.84-$1.90 if this makes it above $3 I will leave mostly all of it in and subtract profits. I think for this catalyst I am willing to risk short term profits for this upside as it is pretty much an investors dream seems a small sacrifice. Just imo though. Tomorrow should be an interesting day I am feeling it is going to go strong one way or the other 
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