NWBO Northwest Biotherapeutics Inc (QB)

 

 

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)

October 8, 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

(Address Of Principal Executive Offices) (Zip Code)

 

(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 email inquiry received from a shareholder, the Registrant responded as set forth in the response attached as 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)

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: October 8, 2015	By:	/s/ Linda Powers
		Linda Powers, Chief Executive Officer, Chairperson

 

 

 

EXHIBIT 99.1

 

 

Shareholder inquiry:   What is going on with the change in completion date of the Phase 3 trial on clinicaltrials.gov?  Is there a new change or delay in the trial?

 

Company answer:        No, there is no new change or delay in the Phase 3 trial.  In all of our public presentations all year long, we have stated that we anticipated finishing the recruitment this fall, and reaching the primary endpoint around approximately the end of summer or September of next year.  The clinicaltrials.gov profile was very out of date, and the change of date in that profile from September of this year to October of next year simply conforms the clinicaltrials.gov profile to the information we have provided publicly all year long, plus about a month of cushion to take account of the temporary hold on new screening for the trial as we announced in August. 

 

We are also updating the profile to correct the number of patients.  As stated in all of our presentations for over a year, the total enrollment will be 348.  The clinicaltrials.gov profile was very out of date in listing 300.  We will simply be conforming the number in the profile to the number we have long presented publicly.