Key Developments: Athersys Inc (ATHX.OQ)
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Latest Key Developments (Source: Significant Developments)
Athersys Inc Announces Exercise Of Overallotment Option
Athersys Inc announced that it received $2.8 million of net proceeds from the exercise, in full, of the underwriters' over-allotment option for 2,970,300 shares of its common stock. Taking this into account, Athersys sold a total of 22,772,300 shares of its common stock, representing gross proceeds of $23 million, to new and existing investors who participated in the underwritten offering. Athersys intends to use the net proceeds from the offering for working capital and general corporate purposes, including the funding of its ongoing clinical trials. Full Article
Athersys Inc Prices Public Offering of Common Stock
Athersys Inc announced that it has priced its offering of common stock. The Company has agreed to sell 19,802,000 shares of common stock through an underwritten public offering at $1.01 per share, which was the closing price of its common stock on October 25, 2012. In connection with the offering, the underwriters have been granted an over-allotment option to purchase an additional 2,970,300 shares of common stock. Both existing investors and new investors are participating in the offering. Athersys intends to use the net proceeds from the offering for working capital and general corporate purposes, including the funding of its ongoing clinical trials. Piper Jaffray & Co. is acting as the sole book-running manager of the offering, and First Analysis Securities Corporation is acting as co-manager of the offering. Leerink Swann LLC and WBB Securities LLC are acting as financial advisors in connection with the offering. The offering is expected to close on October 31, 2012. Full Article
Athersys Inc Receives Orphan Drug Designation For MultiStem In Hurler's Syndrome
Athersys, Inc. announced that MultiStem, Athersys' proprietary cell therapy, has been granted orphan drug designation by the U.S. Food and Drug Administration for the treatment of Hurler's Syndrome, also known as mucopolysaccharidosis type I or MPS-I. Hurler's Syndrome is a lysosomal storage disorder that affects approximately 1 of every 100,000 children. Orphan drug designation, which is intended to facilitate drug development, provides substantial potential benefits to the sponsor, including funding for certain clinical studies, study-design assistance, tax incentives and seven years of market exclusivity for the product upon regulatory approval. Full Article
Athersys Inc-Publication In Cell Transplantation Indicates That MultiStem Could be Used In Treatment of Orphan Neurological Disorders; Announces Issuance Of U.S. Patent 7,927,587
Athersys Inc announced the publication in the scientific journal, Cell Transplantation, of an article that describes the results of a preclinical study evaluating the administration of MultiStem for the treatment of MPS-I (or Hurler's Syndrome). The article, authored by investigators at the University of Minnesota together with scientists from Athersys, describes preclinical study results suggesting that the stem cells could provide benefit to patients suffering from lysosomal storage disorders, such as Hurler's Syndrome. The published study demonstrates that an injection of MultiStem cells in neonatal MPS-I mice reduces the accumulation of GAGs in the brain thereby resulting in improvements in behavioral and motor function in the diseased mice. The results suggest that MultiStem treatment may have relevance for certain orphan genetic diseases such as lysosomal storage diseases, said Dr. Robert Mays, Head of Neuroscience at Athersys and one of the co-authors of the manuscript. The Company also announced the issuance of U.S. patent 7,927,587, which covers the use of non-embryonic, multipotent stem cells for the treatment of lysosomal storage diseases. The patent applies to Hurler's Syndrome and other lysosomal storage disorders, such as Fabry's disease, Gaucher's disease, Niemann-Pick disease and Batten's disease, among many others. Full Article
Athersys Inc Receives U.S. Patent Covering The Suppression of Graft-versus-Host Disease Associated With Hematopoietic Stem Cell Transplantation With Adult Stem Cells
Athersys Inc announced that it has been granted U.S. patent 8,147,824 that covers the use of non-embryonic, multipotent stem cells for the reduction in severity or prevention of Graft-versus-Host Disease (GvHD), a serious condition associated with hematopoietic stem cell transplants (HSCTs) used to treat leukemia and related conditions. Athersys recently completed a successful clinical study evaluating the adjunctive administration of MultiStem for prevention of GvHD, an indication for which the company has already received orphan drug designation. The issued patent covers the use of MultiStem, Athersys' proprietary cell product platform, for the suppression of GvHD when administered in conjunction with an HSCT. The patent covers the administration of non-embryonic, multipotent stem cells derived from bone marrow as well as other tissues sources and applies to single or repeat dosing over a broad dose range in the context of HSCT-based treatment. Full Article
Athersys Inc Announces Positive Results Of MultiStem Clinical Trial For Hematopoietic Stem Cell Transplant Support And Prevention Of Graft-Versus-Host Disease
Athersys Inc announced positive results from its Phase I clinical trial of MultiStem, its cell therapy product, administered to individuals undergoing allogeneic hematopoietic stem cell transplants (HSCT) for the treatment of leukemia and related conditions. According to the Center for International Blood and Marrow Transplant Research, there are approximately 25,000 allogeneic HSCT performed annually, globally. The study demonstrated that MultiStem therapy was well tolerated in both the single infusion and repeat infusion arms and also suggested that the therapy may provide benefit to recipients of allogeneic HSCT, such as reducing the incidence and severity of Graft-versus-Host Disease (GvHD) as compared to historical clinical experience. The results are consistent with previous preclinical studies that show that MultiStem provides multiple benefits in HSCT and other transplant models, such as reducing inflammatory damage and promoting graft acceptance. Full Article
Athersys Inc Secures $3.6 Million In Grant Funding For Stem Cell Product Development
Athersys Inc announced grant funding aggregating $3.6 million to further advance its MultiStem product programs and cell therapy platform. Specifically, Athersys was awarded a SBIR Fast-Track grant of up to $1.9 million from the National Institute of Neurological Disorders and Stroke (NINDS) to develop MultiStem for the treatment of traumatic brain injury (TBI). In addition, Athersys' subsidiary based in Belgium, ReGenesys BVBA, was awarded a $1.2 million (EUR0.9 million) grant from the Belgium's Agency for Innovation by Science and Technology (IWT) to further develop cell therapy formulations and manufacturing capabilities. The Company has also been awarded funding recently to work in other areas, such as using MultiStem to treat chronic cardiovascular disease. Full Article
Athersys Receives U.S. Patent Covering Treatment Of Cardiovascular Disease With Adult Stem Cells
Athersys announced that it has been granted U.S. patent 8,075,881 that covers the use of non-embryonic multipotent stem cells for the treatment of cardiovascular conditions including myocardial infarction, or heart attack, congestive heart failure, myocardial ischemia and other heart conditions. The patent also provides protection for multiple techniques for delivering the stem cells to treat the conditions. Athersys also announced the issuance in 2011 of more than 25 patents in the U.S. and other countries covering non-embryonic multipotent stem cells, their production, and usage. The issued patents cover Athersys' MultiStem product platform, which is an investigational stem cell therapy that has demonstrated therapeutic potential to treat a broad range of indications in the cardiovascular, neurological, and inflammatory and immune condition disease areas. Full Article
Athersys Announces Termination Of Its Collaboration With Angiotech Pharmaceuticals, Inc. To Co-Develop Cell Therapy In The Cardiovascular Field.
Athersys announced the termination of its collaboration with Angiotech Pharmaceuticals, Inc. (Angiotech) to co-develop cell therapy in the cardiovascular field. In connection with the mutual termination, Athersys has regained all rights in its MultiStem cardiovascular program, allowing it greater flexibility in clinical development and the opportunity to pursue new business collaborations within or including this important field. Athersys and Angiotech negotiated an agreement to terminate the collaboration and license agreements between the parties. As a result of the termination, Athersys has regained all rights for developing its stem cell technologies and products for cardiovascular disease indications, including AMI, congestive heart failure, chronic ischemia and peripheral vascular disease, and Angiotech will no longer have any license rights or options with respect to Athersys' technologies and products. Through the termination, Angiotech will have no further funding obligations as relates to these programs. As a result, the termination would affect Athersys' future costs of development for ongoing cardiovascular programs, such as AMI, it also removes a significant encumbrance affecting Athersys' business development opportunities with other pharmaceutical, biotechnology and medical products companies. Full Article
Athersys Enters Into $20 Million Equity Purchase Agreement With Aspire Capital
Athersys announced that it has entered into a Common Stock Purchase Agreement with Aspire Capital Fund, LLC (Aspire Capital) whereby Aspire Capital has committed to purchase up to $20 million of Athersys' common stock in multiple transactions over the next two years at a modest discount to the then prevailing market price. At closing, Aspire Capital purchased 666,667 shares of common stock for $1.50 per share, which adds to its current holdings in the Company, acquired through participation in the financing completed in February 2011. Full Article

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