Current Report Filing (8-k)
February 08 2017 - 11:25AM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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 8, 2017
NORTHWEST BIOTHERAPEUTICS, INC.
(Exact name of registrant as specified in
its charter)
Delaware
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001-35737
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94-3306718
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(State or other jurisdiction of
incorporation or organization)
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(Commission File Number)
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(IRS Employer
Identification No.)
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4800 Montgomery Lane, Suite 800
Bethesda, MD 20814
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(Address of principal executive offices)
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(204) 497-9024
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(Registrant’s telephone number, including area code)
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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:
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¨
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Written communications pursuant to Rule 425 under the
Securities Act
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¨
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Soliciting material pursuant to Rule 14a-12 under the
Exchange Act
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¨
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Pre-commencement communications pursuant to Rule 14d-2(b)
under the Exchange Act (17 CFR 240.14d-2(b))
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¨
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Pre-commencement communications pursuant to Rule 13e-4(c)
under the Exchange Act (17 CFR 240.13e-4(c))
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Item 8.01. Other Events.
Northwest Biotherapeutics, Inc. (the “Company”)
has received a number of shareholder inquiries asking for clarification whether the 331 patients enrolled in its Phase III DCVax®-L
Trial includes the 32 patients in a Pseudo-Progressor arm or those 32 patients are in addition to the 331 patients enrolled.
The Company is clarifying that the 32
patients in the Pseudo-Progressor Arm are in addition to the 331 patients enrolled in the Main Arm of the Trial and are not
included in the 331. The Company notes that there are 90 patients in other separate arms of the Trial in addition to
the 331 patients in the Main Arm, making a total of 421 patients. The 90 patients include the 32 patients in the
Pseudo-Progressor Arm, 55 patients in the Information Arm, and 3 patients who were enrolled at the very beginning of the
Trial when it was randomized but not yet blinded. The Trial was blinded after those initial patients were
enrolled. In addition to these 421 patients, the Company has treated a substantial number of patients on a
compassionate basis under an Expanded Access Protocol.
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.
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NORTHWEST BIOTHERAPEUTICS, INC.
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Date: February 8, 2017
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By:
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/s/
Linda F. Powers
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Name: Linda F. Powers
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Title: Chief Executive Officer
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