SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT PURSUANT TO SECTION 13 OR 15(D) OF
THE SECURITIES EXCHANGE ACT OF 1934
| Date of report (Date of earliest event reported) | February 10, 2015 |
| NORTHWEST BIOTHERAPEUTICS, INC. |
| (Exact Name of Registrant as Specified in Its Charter) |
| Delaware | 0-33393 | 94-3306718 |
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
|
4800
Montgomery Lane, Suite 800, Bethesda, MD 20814
| ||
| (204) 497-9024 |
| (Registrant's Telephone Number, Including Area Code) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 7.01. Regulation FD Disclosure.
In response to an inquiry received from a shareholder concerning a presentation made by Northwest Biotherapeutics, Inc. (the “Registrant”) at an investment conference on February 9, 2015, the Registrant responded with some further information in the response set forth in Exhibit 99.1 hereto.
The information in this Item 7.01, including the exhibit attached hereto, is furnished solely pursuant to Item 7.01 of Form 8-K. Consequently, such information is not deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities of that section. Further, the information in this Item 7.01, including the exhibit, shall not be deemed to be incorporated by reference into the filings of the registrant under the Securities Act of 1933.
Item 9.01. Financial Statements and Exhibits.
| (d) | List of Exhibits |
| Exhibit No. | Description |
| Exhibit 99.1 | Response to shareholder |
SIGNATURES
PURSUANT TO THE REQUIREMENTS OF THE SECURITIES EXCHANGE ACT OF 1934, THE REGISTRANT HAS DULY CAUSED THIS REPORT TO BE SIGNED ON ITS BEHALF BY THE UNDERSIGNED THEREUNTO DULY AUTHORIZED.
| NORTHWEST BIOTHERAPEUTICS, INC. | |||
| Date: February 10, 2015 | By: | /s/ Linda Powers | |
| Linda Powers, Chief Executive Officer, Chairperson | |||
EXHIBIT 99.1
Dear xxxxxx,
Let me put your mind at ease.
Linda’s reference to “expansion” of the Phase III GBM trial relates to an increase in the number of trial sites, not the number of patients in the trial. A key reason that we are continuing to add more trial sites, even in the late stages of the trial, is that this can only help shorten the time to completion of patient recruitment and the trial. In addition, continuing to add more sites during the trial means that more sites will be prepared in advance for commercialization.
Thanks for checking to clarify this important point, and thanks for your continuing support and inquiries,
Sincerely,
Les Goldman
From: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
Sent: Monday, February 09, 2015 5:19 PM
To: Les Goldman
Subject: Another Expansion / Extension of Phase III?
Dear Mr. Goldman,
As a private NWBO individual investor over the last two years, I am wondering what today's presentation mean in terms of Phase III and its Estimated Primary Completion Date.
It seems that other companies are hurrying up to finish immunotherapy trials as early as possible. While I appreciate good science and the first extension of this Phase III, another extension seems to put NWBO on the back foot with regards to other therapies (IC, etc.). NWBO may be missing its window of opportunity, in which case I need to revise my investment strategy with regards to NWBO.
Would you shed some light on the announced extension?
Best regards,
xxxxxxxx