Athersys, Inc. (NASDAQ:ATHX)

CAPS Rating: 2 out of 5

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Member Avatar zzlangerhans (99.80) Submitted: 1/4/2015 1:21:02 AM : Underperform Start Price: $1.64 ATHX Score: -76.26

Athersys is really two stories as a trade. One story is Athersys the company. The second is the retail cult of Athersys. The retail cult causes the share price to gyrate wildly depending on the relative degree of optimism among their ill-informed ranks and the closeness of the approaching catalysts. Those price movements are hard to predict and it's easy to get stuck in a bad position whichever way one bets. Athersys the company, like any other biopharma, ultimately must progress their therapeutic candidates through the stages of development, get regulatory approval, and sell them. Of course, any biopharma effectively managed with the prime directive of prolonging its own survival can last for decades even if their pipeline is a series of inert substances. Therefore, while Athersys the company chugs along and management collects their salaries and options, the retail cult creates an irregular oscillating wave in the long term share price.

I had both a cult green thumb and a company red thumb ready to go on Athersys, and it just so happened that the stock has risen in a bull market for biopharma with results of the placebo-controlled phase II trial of MultiStem for ischemic stroke approaching at the end of this quarter (probably). Therefore, my rating is underperform and I'll focus on the upcoming failure of the trial, instead of the possible run-up in share price going into data.

What is MultiStem? It is Athersys's proprietary stem cell product derived from donor adult bone marrow which can be administered to patients with a variety of diseases without any need for tissue matching. This allows Athersys to package MultiStem as a uniform "off-the-shelf" product which can be thawed and administered without any prior preparation of the product or the patient. As the Church Lady would say, how conveeeenient. Athersys has performed phase I trials of MultiStem in acute myocardial infarction, as support for stem cell transplantation in hematologic malignancies, and in graft-versus-host disease and have claimed encouraging results every time. How does MultiStem exert these beneficial effects in such a diverse array of diseases? Well, that's where things get murky. According to Athersys, "factors expressed by MultiStem have the potential to deliver a therapeutic benefit in several ways, such as reducing inflammation, protecting damaged or injured tissue, and enhancing the formation of new blood vessels in regions of ischemic injury. These cells exhibit a drug-like profile in that they act primarily through the production of multiple factors that regulate the immune system, protect damaged or injured cells, promote tissue repair and healing, and the cells are subsequently cleared from the body over time."

Of course, MultiStem is able to perform all these functions despite the fact that recipients have their own bone marrow, their own stem cells, their own immune systems that have evolved over millions of years to repair injuries and deal with inflammation. What exactly are the factors produced by MultiStem and how are they different from factors already present in the recipient? Is it a quantity issue? A regulatory issue? Athersys doesn't say. Like virtually every other microcap stem cell soup peddler, they'd prefer to think everything happens via some sort of microscopic magic. Why doesn't the host immune system recognize MultiStem as foreign? Do the cells not express HLA antigens? Athersys doesn't want to say. They do say that MultiStem cells disappear from the recipient over time. They describe this as a positive, and glide over the possibility that the cells are simply being cleared by the recipient immune system without ever having any kind of therapeutic effect.

Athersys is fond of claiming evidence of therapeutic benefit in their phase I trials, despite the small size of the trials and lack of controls. Interestingly, their two phase II programs for ulcerative colitis and ischemic stroke were not preceded by any phase I trials I could identify for those indications. In April 2014, Athersys retail cult members found out that there's a big difference between small uncontrolled phase I trials and larger, placebo-controlled phase II trials when the company conceded that MultiStem showed no meaningful benefit in the ulcerative colitis trial. The resultant 70% haircut from the run-up highs sent many cult members away to lick their wounds, but we all know that in biopharma hope springs eternal. The stock is now up substantially from a recent low of 1.2 and who could be blamed for suspecting that the share price could be back over 3 before Athersys reveals the ischemic stroke data almost to the year after the ulcerative colitis debacle? If the current upswing proves to be a false start, I might temporarily join the cult myself under 1.3. If not, I'll stick with betting against Athersys the company.

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Member Avatar ravngm (< 20) Submitted: 10/23/2014 2:11:59 PM : Outperform Start Price: $1.31 ATHX Score: +121.20

Pipeline. Upside of business. Risky....

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Member Avatar Dublin43016 (< 20) Submitted: 2/22/2014 10:51:56 AM : Outperform Start Price: $4.03 ATHX Score: -41.84

1. Recent regulatory changes to accelerate regenerative medicine use in Japan, will allow faster development of their products. CEO has already made several trips so as to get his ducks in a row.

2.Second quarter results on phase II study on Ulcerative Colitis done by Pfizer using ATHX's their multistem cells.

3. Mid year results on the use of multistem on a phase II study in the use of the cells for the treatment of ischemic stroke a potential 20 billion market.

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Member Avatar bburr4307 (< 20) Submitted: 1/30/2014 9:02:27 PM : Outperform Start Price: $3.84 ATHX Score: -42.93

ATHX is a very interesting bet in my opinion, because of the impact their product has of changing the medical world and treatments as we know it. I've been struggling with whether 3D printing might have a profound effect in the medical world also, and though I think 3D printing will be a game changer in other areas and hold DDD stock, I think the path that ATHX is on with their stem cell product is better and much more pratical in the short term and long term due to the moral, ethical, and legal complications that will be associated with 3D printing in the medical field. The product that ATHX is and has been working on is truly a remarkable product that has endless possibilities of transforming medical science and the curing of devistating diseases as we know it and as long as the company plan continues on it's course I plan to be invested. In fact, as of now, if I had only 1 choice od what stock to own this would be my pick. Next bump up should be around April when the ongoing trials finish up, and Japan looks to be the first area of opportunity to put their product to use. I've been invested and following ATHX for over a year and never have been as excited about a stock as this one. I see years of growth in the future as new opportunities to expand the usage of their system become available. As a note, due to the type of system they are using, there should not be the moral or ethical questions related to the stem cell therapy they propose. I'm in for the long haul as I see this becoming a 1000 bagger in the future.

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Member Avatar Atwsdrl2012G (< 20) Submitted: 12/22/2013 1:15:55 AM : Outperform Start Price: $2.22 ATHX Score: +16.67

High risk but also potential 10 banger in 15 yrs

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Member Avatar alfredogonzalez6 (< 20) Submitted: 8/20/2013 7:27:39 PM : Outperform Start Price: $1.80 ATHX Score: +35.57

With them heading into stage II in either 1Q/2Q of 2014, everything looks promising, so definitely in it for the long run.

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Member Avatar itsthedudeguy (42.01) Submitted: 4/9/2013 6:25:42 AM : Outperform Start Price: $1.73 ATHX Score: +35.06

20 mil in R&D in 2012

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Member Avatar toegar2000 (58.60) Submitted: 3/2/2013 10:19:00 AM : Outperform Start Price: $1.48 ATHX Score: +59.64

Good up and coming product line in the works.

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Member Avatar usubanas (99.73) Submitted: 2/1/2013 1:04:43 AM : Outperform Start Price: $1.36 ATHX Score: +76.19

Inflammatory bowel disease Ph 2 results in fall 2013; stroke (HUGE market) Ph 2 in Q2 2014. At 85M market cap, if any of those programs work, this will be more than a 10-bagger.

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Member Avatar JaiYen (< 20) Submitted: 1/26/2012 1:27:32 PM : Outperform Start Price: $1.88 ATHX Score: -3.36

Great place to park speculative money. Anything stem cell has sex appeal that could really pop on positive news. Partnership with PFE says a lot about the science behind this company and so far management seems very savvy about locking up patents and forming strategic partnerships. This is my BIG speculative play.

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Member Avatar atarheelfool (< 20) Submitted: 8/3/2011 9:47:17 PM : Outperform Start Price: $2.54 ATHX Score: -54.24

Connection to Pfizer shows legitimacy. Management is top notch and patents for stem cell research puts this Athersys in a great position to do well for a long time.

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Member Avatar Zo3adams (< 20) Submitted: 7/25/2011 1:00:50 AM : Outperform Start Price: $2.71 ATHX Score: -50.18

Waiting patiently for a very successful clinical trial to see a big jump. Long term game, this small company is ran by expert-in-field scientific talent and very likely to strike a home-run

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Member Avatar London2485 (63.25) Submitted: 3/10/2011 5:26:09 PM : Outperform Start Price: $2.48 ATHX Score: -44.72

This is a real money stock as well, purchased right around this amount very recently.

Their flagship product, MultiStem, appears to have application in a wide range of areas, from leukemia to stroke. The Phase I trials are complete, and the product has been pretty successful in stroke victims. The fact that it's efficacy is compromised by how soon it can administered to the stroke victim makes little impact. ALL interventions with stroke victims lose efficacy over time.

However, the positive results have so far only been seen in animals. The company will probably need to raise further capital.

If you can tolerate high risk, consider adding Athersys (it's my highest risk stock in my real life portfolio).

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Member Avatar btown819 (94.79) Submitted: 12/3/2010 9:29:43 PM : Outperform Start Price: $2.54 ATHX Score: -62.37

As of December 2010, Athersys is a speculative stock due to the small revenues, continued losses, and potential share dilution. With a market cap of under $50M, a share price of roughly $2.50 and 70K share per day trading volume, I think this one has been off of wall street's radar. On the other hand, I think Athersys is a small gem of a company that has lots of potential. Athersys has no debt, and roughly $15M in cash as of their last 10Q. Of most interest to me is their Multistem product. They have had success with their multistem product for acute myocardial infarction and for stroke in animal models, but no conclusive statistically valid testing has been done in humans yet. So far the results are limited (Phase I), but have been promising to date even though it is still in the early stages.

The multistem product is a biologic product manufactured from stem cells. It is somewhat unique in the stem cell area because it acts more like a drug in that it is administered through an IV or catheter and is flushed from the body naturally. The stem cells are derived from adult stem cells (i.e. bone marrow from a qualified donor) and does not involve embryonic stem cells. From one acceptable donor, Athersys is able to create hundreds of thousands of doses of the product. The product also has a shelf life of 4 years. The product does not require the use of immune suppressive drugs or tissue matching between donor and recipients and it has a consistent safety profile. Current applications of multistem are being pursued in the areas of inflammatory bowel disease (partnered with Pfizer), stroke and acute myocardial infarction (partnered with Angiotech). In AMI (i.e. heart attack), multistem is designed as a supplement to the current standard of care and not a replacement. Management has been effectively utilizing partnerships at both the university and commercial level to help with development from both a cost and capability standpoint while maintaining a reasonable cash burn rate to date. They have also been very conscious of working with the FDA to develop a strong safety profile for their product which may be leveraged in the future if they try to extend the application of the product to different areas and to allay any safety concerns the FDA may have. I think the current share price already prices in some future share dilution.

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Member Avatar ebitdat (25.23) Submitted: 9/16/2010 8:21:09 PM : Outperform Start Price: $2.99 ATHX Score: -88.87

Product appears commercially viable and already has a nice partnership agreement. Upcoming presentation of phase I data in heart patients should provide a nice boost, and an opportunity to gauge interest from other partners.

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