>>BOTHELL, Wash., Jan. 31 /PRNewswire-FirstCall/ -- Northwest Biotherapeutics (OTC Bulletin Board: NWBT.OB - News) today announced that it has received clearance from the Food and Drug Administration (FDA) to begin assessment of its cell based dendritic cell product candidate, DCVax(R)-Prostate, in a Phase III clinical trial. This trial is based on promising clinical data from a previously conducted Phase I/II clinical trial. The double blinded, placebo controlled Phase III clinical trial is expected to enroll about 600 patients at 30-50 sites throughout the United States.
"The initiation of this Phase III trial for non-metastatic hormone independent prostate cancer patients represents a major milestone achievement for our lead product candidate, DCVax(R)-Prostate, and for implementation of our new business strategy, and progress with our recent recapitalization agreement with Toucan Capital of Bethesda, MD" stated Alton L. Boynton, Ph.D., President, Chief Operating Officer, and a co-founder of NWBT. "I believe DCVax(R)-Prostate represents a promising new treatment for non-metastatic hormone independent prostate cancer for which there is currently no FDA approved product."
Northwest Biotherapeutics previously received clearance through the FDA for a Phase II clinical trial for DCVax(R)-Brain, a promising new treatment for Glioblastoma Multiforme which is the most common, and lethal form of brain cancer. The company intends to begin this multi-site clinical trial later this year. In addition, the DCVax(R) platform can be used for multiple cancer indications, and NWBT has completed preclinical work targeted for a Phase I clinical trial for non-small cell lung cancer and head and neck cancer.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on discovering, developing and commercializing immunotherapy products that safely generate and enhance immune system responses to effectively treat cancer. The company has completed Phase I/II clinical trials for its lead product candidate DCVax(R) -- Prostate and completed preclinical work for several other product candidates targeting multiple cancers. Three technologies form the basis of our product candidates: a dendritic cell-based immunotherapy platform applicable to multiple cancers; a therapeutic monoclonal antibody product candidate applicable to multiple cancer types; and an antibody-based imaging agent for metastatic prostate cancer.<<
One wonders how they're going to do this. Stock currently trades on the pink sheets for 4 cents a share. Toucan gave 'em enough dough to run this trial? NWBT.PK must be a) issuing hundreds of millions of shares, or b) trading way below cash. Without looking, I'd guess a. Your initial comment on this one when they floated the IPO? "Treat it roughly."
Good call. Toucan must own the whole works. Must worth a try at a pump to them, I guess. If I wasn't busy with more meaningful things, I would probably find this interesting to follow.
Edit: Looking is wierd. They should be out of cash already:
>>Form 8-K for NORTHWEST BIOTHERAPEUTICS INC
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30-Dec-2004
Entry Material Agreement, Financial Statements and Exhibits
ITEM 1.01 Entry Into a Material Definitive Agreement.
Northwest Biotherapeutics, Inc. (the "Company") announced today that, on December 27, 2004, it received a $250,000 loan from Toucan Capital Fund II, L.P. ("Toucan"). The loan accrues interest at 10% per year, matures on December 27, 2005, and the principal and interest is convertible into capital stock of the Company, generally at Toucan's option, prior to repayment. The principal and interest on the loan is currently convertible at $0.04 per share (subject to adjustment). In connection with this new loan, the Company has issued a warrant to Toucan, which is exercisable for up to 2.5 million shares of the Company's capital stock. The exercise price of the warrant is the lesser of (i) $.10 per share (subject to certain adjustments); or (ii) a 35% discount to the average closing price of the Company's common stock during the twenty trading days prior to the first closing of the sale of convertible preferred stock of the Company, but not less than $.04 per share. The Company believes that the additional $250,000 received from Toucan on December 27, 2004 will be sufficient to satisfy its cash requirements until January 8, 2005.
To date, the Company has issued eight promissory notes to Toucan pursuant to which Toucan has loaned the Company an aggregate of $4.35 million. In connection with the issuance of promissory notes to Toucan, the Company has issued and Toucan has received warrants that are currently exercisable for an aggregate of up to 98.5 million shares of the Company's capital stock.
In connection with the recent loan from Toucan, the Company and Toucan agreed to amend the Amended and Restated Recapitalization Agreement, dated as of July 30, 2004, amended on October 22, 2004 and on November 10, 2004, between the parties ("Amendment No. 3"). Amendment No. 3 extends the bridge period which previously expired on December 17, 2004 through January 8, 2005 and removes a covenant to which the Company was previously subject. During the bridge period the Company generally is prohibited from entering into discussions with any third party regarding a sale of the Company, its assets or the issuance of its securities.
Also in connection with the recent loan from Toucan, the Company and Toucan agreed to amend the Amended and Restated Binding Term Sheet dated April 26, 2004, and amended and restated on October 26, 2004 between the parties (the "Term Sheet"). The Term Sheet, as amended, reduced warrant coverage in the potential private placement by $250,000 and removed a closing condition.
The Amended and Restated Recapitalization Agreement, as amended, contemplates a proposed equity financing that would provide for the potential issuance and sale of up to $40 million of convertible preferred stock (including any shares issuable upon conversion of bridge funding, but not including any shares issuable upon exercise of warrants, options, and similar instruments or obligations), in one or more closings over a period of 12 months from the first closing of the sale of convertible preferred stock. If issued, the convertible preferred stock will be issued at a price per share equal to the lesser of $0.10 (as adjusted for stock splits, stock dividends and the like) or a 35% discount to the average closing price of the Company's common stock during the twenty trading days prior to the first closing of the proposed equity financing, but not less than $0.04 per share. The proposed equity financing is contingent upon the Company complying with covenants in the Amended and Restated Recapitalization Agreement, as amended, and locating investors who are willing to invest in the Company on the terms proposed.
The foregoing description of Amendment No. 3, the note, the warrant and the Term Sheet, all of which are filed as exhibits to the Form 8-K, are qualified in their entirety by reference to the full text of the agreements.
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Table of Contents
Item 9.01 Financial Statements and Exhibits
(c) Exhibits.
10.1 Amendment No. 3 to the Amended and Restated Recapitalization Agreement
between Northwest Biotherapeutics, Inc. and Toucan Capital Fund II, L.P.,
dated December 27, 2004.
10.2 Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory
Note in the principal amount of $250,000 between Northwest Biotherapeutics,
Inc. and Toucan Capital Fund II, L.P. dated December 27, 2004.
10.3 Warrant to purchase securities of the Company dated December 27, 2004
issued to Toucan Capital Fund II, L.P.
10.4 Amendment to Amended and Restated Binding Term Sheet dated December 27,
2004.<<
There's been no news of preferred convert tranches going out between this 8-K and the above PR. Perhaps, the PR was actually released on the 7th, but, since their telephone was repossesed along with the CEO's car, he had to walk it to PR Newswire, and arrived today.
Smells.
Cheers, Tuck |
