$CUR Form 8-K

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625
Biotech Stocks

Form 8-K for NEURALSTEM, INC.


12-Mar-2015

Regulation FD Disclosure, Other Events, Financial Statements and Exhibits

Item 7.01 Regulation FD Disclosure.On March 12, 2015, Neuralstem, Inc. (“Company”) presented data from the Phase II trial of NSI-566 spinal cord-derived neural stem cells for the treatment of amyotrophic lateral sclerosis (ALS) at the Barclays Global Health Care Conference in Miami, Florida. The clinical trial met primary safety endpoints and established a maximum tolerated dose of 16 million cells delivered in 40 injections. Additionally, secondary efficacy endpoints such as the ALSFRS (a standard clinical test to evaluate functional status of ALS patients) and grip strength at nine months post-surgery were also evaluated. A copy of the slides presented at the conference is attached to this report as Exhibit 99.01. The slides can also be viewed on the Company’s website at www.neuralstem.com. An audio copy of the presentation is also available on the Company’s website.

The information contained in this Item 7.01 to this Current Report on Form 8-K and the exhibit attached hereto pertaining to this item shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information or such exhibits be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing. The information set forth in the exhibits to this Form 8-K relating to this item 7.01 shall not be deemed an admission as to the materiality of any information in this report that is required to be disclosed solely to satisfy the requirements of Regulation FD.

 

Item 8.01 Other Events.On March 12, 2015, the Company announced that top line data from the Phase II trial of NSI-566 spinal cord-derived neural stem cells for the treatment of amyotrophic lateral sclerosis (ALS) at the Barclays Global Health Care Conference in Miami, Florida. The clinical trial met primary safety endpoints and established a maximum tolerated dose of 16 million cells delivered in 40 injections. Additionally, secondary efficacy endpoints such as the ALSFRS (a standard clinical test to evaluate functional status of ALS patients) and grip strength at nine months post-surgery were also evaluated. A copy of the press release is attached to this report as Exhibit 99.02

 

Item 9.01. Financial Statements and Exhibits.

Exhibit
No.                  Description
99.01     Slides presented on March 12, 2015
99.02     Press Release dated March 12, 2015

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