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STEM > SEC Filings for STEM > Form 8-K on 18-May-2009All Recent SEC Filings

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Form 8-K for STEMCELLS INC


18-May-2009

Other Events


Item 8.01 Other Events.

On May 15, 2009, StemCells, Inc. (the "Company") announced that the U.S. Patent and Trademark Office (the "PTO") has mailed notices of intent to issue ex parte reexamination certificates for U.S. Patent Nos. 6,294,346 and 7,101,709, which claim, respectively, methods for using neural stem and progenitor cells for the screening of drugs and biological agents. The '346 and '709 patents are exclusively licensed by the Company. They are the last of the five patents subjected to reexamination proceedings commenced by Neuralstem, Inc. in late 2006 and early 2007. Because all five of these patents have now been upheld by the PTO, the Company has filed a motion with the federal district court in Maryland to re-open the Company's first patent infringement case against Neuralstem. The Company has also filed a motion with the court to consolidate its first and second patent infringement cases against Neuralstem into one.

The Company's press release announcing the action by the PTO and the related court proceedings is filed as Exhibit 99.1 to this Current Report on Form 8-K, and is incorporated herein by reference.

Apart from statements of historical fact, the text of this press release constitutes forward-looking statements regarding, among other things, the future business operations of StemCells, Inc. (the "Company") and the validity, enforceability and value of the Company's patents. These forward-looking statements speak only as of the date of this news release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect management's current views and are based on certain assumptions that may or may not ultimately prove valid. The Company's actual results may vary materially from those contemplated in such forward-looking statements due to risks and uncertainties to which the Company is subject, including uncertainty regarding the validity and enforceability of our issued patents; litigation risks, including the risk that patents issued by the PTO may be held to be invalid or not infringed, and the high cost of patent litigation; risks as to whether the FDA or other applicable regulatory agencies will permit the Company to continue clinical testing in NCL, PMD or in future clinical trials of proposed therapies for other diseases or conditions despite the novel and unproven nature of the Company's technologies; uncertainties about whether the Company will receive the necessary support of a clinical trial site and its institutional review board to initiate a clinical trial in PMD; uncertainties regarding the Company's ability to obtain the increased capital resources needed to continue its current and planned research and development operations, including such operations of the company for non-therapeutic applications, and to conduct the research, preclinical development and clinical trials necessary for regulatory approvals; uncertainty as to whether HuCNS-SC and any products that may be generated in the future in the Company's cell-based programs will prove safe and clinically effective and not cause tumors or other adverse side effects; uncertainties regarding the Company's manufacturing capabilities given its increasing preclinical and clinical commitments; and other factors that are described under the heading "Risk Factors" in Item 1A of Part II of the Company's Quarterly Report on Form 10-Q.


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