Press Releases
Media Contact:
Anthony Deasey
240-497-9036
Financial Results for the Year Ended 31 December 2007
Bethesda, MD – 16 April 2008 – Northwest Biotherapeutics, Inc. (AIM:NWBS and NWBT; OTC BB: NWBO), the US-based biotechnology company focused on developing immunotherapy products for cancer, today announces its results for the year ended 31 December 2007.
Operational Highlights
- January - Phase II study, designed and powered as a pivotal trial, using DCVax®-Brain to treat Gioblastoma multiforme (GBM) initiated in the United States.
- February - Submitted application to Bundesamt für Gesundheit (BAG) in Switzerland for Authorization for Use of DCVax®-Brain in Switzerland.
- May - Secured product supply with follow-on contract with Cognate BioServices to manufacture DCVax®-Brain product.
- June - BAG Authorization granted, subject to fulfillment of certain implementation conditions.
- December - Marketing Authorization Application (MAA) submitted to Swissmedic requesting full marketing approval of DCVax®-Brain in Switzerland.
- December - Phase I/II study, funded by the Ovarian Vaccine Initiative, a private philanthropic organization, using DCVax®-L to treat recurrent ovarian cancer initiated at University of Pennsylvania.
- Strengthened management team with recruitment of Chief Financial Officer, Chief Medical Officer and Vice President of Regulatory Affairs.
Operational Highlights
- Successful initial public offering in June, listing on AIM and raising of £15 million gross proceeds.
- Eliminated debt.
- As of 31 March 2008, the Company had approximately US$ 2.2 million of cash on hand. The Company is in the process of finalizing a debt financing of up to US$ 8.0 million designed to cover its operating cash requirements until the fourth quarter of this year. It is anticipated that up to US$ 4.0 million may be available to the Company by the end of April, and the balance may become available by June.
Commenting on the results, Alton L. Boynton, Chief Executive Officer of NWBT said:
“Northwest made its debut on AIM in June 2007. Since then we have made excellent progress on many fronts including the recruitment of very experienced and highly motivated additions to the management team.
With regard to our clinical programme, we have announced encouraging data from our key DCVax®-Brain trials, the two Phase I clinical trials continuing to show very positive survival data. Of particular significance, the median survival of patients treated with DCVax®-Brain has reached 33.8 months compared to patients treated with the standard of care at 17.1 months and 8 of the 19 patients are still alive having survived for periods between 25 and 92 months.
We have also initiated two additional clinical studies, a Phase II trial in Glioblastoma multiforme, designed and powered as a pivotal trial, and a Phase I/II trial in recurrent ovarian cancer in the United States. We are rapidly building our base of clinical sites in the United States and anticipate having some 40 or more active sites by the summer.
Since June we have completed all of the implementation conditions required by Swissmedic to proceed under the BAG Authorization including establishing a Swiss subsidiary, completing the clean room at our contract manufacturer and submitting a MAA to Swissmedic.”
Detailed results are included in the Form 10-K as filed with the United States Securities and Exchange Commission (“SEC”) on April 15, 2008 and can be viewed by at http://www.rns-pdf.londonstockexchange.com/rns/4372s_-2008-4-16.pdf
For further information, please contact:
Northwest Biotherapeutics
Anthony P. Deasey, Chief Financial Officer |
+ 1 240 497 9024 |
Buchanan Communications
Lisa Baderoon (lisab@buchanan.uk.com)
/ Mary-Jane Johnson / Catherine Breen |
+44 (0)20 7466 5000 |
Collins Stewart Europe Limited
Tim Mickley / Adam Cowen |
+44 (0)20 7523 8350 |
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