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Athersys, Inc. (ATHX) Beginning Due Diligence (chart technicals to come in seperate post)

Beginning points of Due Diligence for Athersys (ATHX)

I am long the stock from $1.24.

My Short Term catalyst Price Target opinion is $1.55 to $1.75, and $2.75 based on if positive Phase II data is reported.

Multiple 2013 Catalysts with upcoming Phase II catalyst:

Ongoing Phase II clinical study being conducted with  partner Pfizer (PFE) that is focused on the administration of MultiStem to patients suffering from treatment refractory ulcerative colitis.

Top line and interim data release time frame for the above study currently being ascertained. When I hear back from company I will update here with the exact information.

The third quarter of 2012 was marked by progress in our two ongoing Phase 2 clinical studies of MultiStem for ulcerative colitis and ischemic stroke," said Gil Van Bokkelen, Ph.D., Chairman and Chief Executive Officer.  "We completed the initial phase of our stroke study, and the independent safety committee reviewed the data, noting that the two doses studied were safe and well tolerated. The committee recommended that we proceed with the remainder of the study using the higher dose level of MultiStem. We believe this dosing level provides the best opportunity to provide a meaningful benefit to patients and are excited about moving the trial ahead, as well as continuing to advance our Phase 2 program in ulcerative colitis with Pfizer.

Inflammatory Bowel Disease : MultiStem is being evaluated in an ongoing Phase II clinical study involving administration of MultiStem to patients suffering from ulcerative colitis, the most common form of Inflammatory Bowel Disease, or IBD. This study is being conducted with our partner, Pfizer Inc., or Pfizer, in ulcerative colitis patients who have an inadequate response or are refractory to current treatment, and is a double blind, placebo-controlled trial that began enrolling patients in 2011. Enrollment of the trial is ongoing and is expected to include approximately 130 patients.

Excerpt from Originally posted piece on  by Brett Sifling. Reposted with full permission.

Athersys has a $111M deal with Pfizer. At the end of 2009, the Pfizer partnership for ulcerative colitis with the use of Athersys' multi-stem platform caused Athersys stock to run from $1 to $5.  This Phase II data is critical because, if positive, it will validate the extreme potential of the medicine in areas that are difficult to treat. This is especially true since the multi-stem therapy can potentially be used on a variety of other platforms. However, negative results can be equally as devastating for the company. Ulcerative colitis treatment has the potential to generate billions since Irritable Bowel Disease (IBD) affects 2.4 million people in the U.S., Europe and Japan which explains the large deal with Pfizer.

Second, Athersys has a partnership with RTI Biologics, Inc. (RTIX) for a bone allograft system. It is expected that RTI Biologics will start generating revenues for Athersys this year. One would expect to hear news about the progress of this partnership and the revenue generation relatively soon.

Third, Athersys has an ongoing Phase II study for ischemic stroke via their multi-stem platform. Ischemic stroke is very difficult to treat because of the limited timeframe to institute treatment. Currently the only FDA approved drug for ischemic stroke is tPA which helps dissolve the blood clot that impedes blood flow to the brain. tPA, however, is only effective if administered within 3-4 hours of the stroke. Athersys Phase II study is evaluating the effectiveness of their medicine in the 24-36 hours following the stroke. This is another billion dollar industry with 2M people suffering from stroke annually in the U.S., Europe and Japan. Results from this study are expected within the next 12 months.

Fourth, Athersys has an interesting compound in their pipeline that is a 5HT2c receptor. This receptor is key for assisting the brain in regulating appetite and food intake that is effective for the treatment of obesity and diabetes. The market places high valuation on weight loss drugs as we have seen with Vivus, Inc. (VVUS), Orexigen Therapeutics, Inc. (OREX) and Arena Pharmaceuticals, Inc. (ARNA). What is unique about the 5HT2c compound is that it can treat patients as a single mode of therapy or in conjunction with recently approved therapies from the aforementioned companies. Athersys has publicly stated during a quarterly conference call they are looking to potentially partner this compound.

Fifth, Athersys was granted orphan drug status for Hematopoietic Stem Cell Transplant / GvHD in April 2012. Phase I was completed in early 2012 for patients suffering from leukemia and other blood-borne cancers. In the highest single dose group "no cases of severe GVHD were observed and there was only one moderate grade (grade 2) that resolved with treatment." There is a huge unmet clinical need for this platform and results, to date, have been extremely favorable.

Sixth, Athersys was partnered with Angiotech Pharmaceuticals to co-develop multi-stem for acute myocardial infarction. The Phase I study was promising, however, Angiotech fell on hard times financially so Athersys recovered all rights. The FDA has already approved their Phase II study, however, Athersys is deciding whether to advance this study alone or partner it.

Lastly, if the aforesaid wasn't enough, the multi-stem platform has the potential to treat other neurological disorders and injuries such as traumatic brain injuries, spinal cord injury and multiple sclerosis. Other treatment platforms for multistem include congestive heart failure, peripheral vascular disease, peripheral artery disease, and critical limb ischemia. Athersys also received orphan drug status for Hurler's Syndrome.

Athersys has a "Company Overview" and "Corporate Fact Sheet" that further details each of their programs.

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