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Thursday 16 April, 2009

Northwest Bio.

Financial Results

RNS Number : 6471Q
Northwest Biotherapeutics Inc
16 April 2009
 



For Immediate Release

16 April 2009

 

        


Northwest Biotherapeutics, Inc.

('NWBT', 'Northwest', or the 'Company')



Financial Results for the Year Ended 31 December 2008


BETHESDA, MD - 16 April 2009 - 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 2008.


Highlights 2008


Recruited additional sites for Phase II DCVax®-Brain clinical trial to treat Glioblastoma multiforms (GBM) in the United States

Continued to accrue patients in the DCVax®-Brain clinical trial for GBM

In communication with Swissmedic with respect to the Marketing Authorization Application (MAA) that was submitted to the agency for marketing DCVax®-Brain in Switzerland

Worked with Cognate BioServices to expand manufacture capacity

Reported two sets of long-term follow up data of DCVax®-Brain Phase I and Phase I/II clinical trials

Reported the Company's first clinical data from DCVax®-L for ovarian cancer: first two patients who completed the Company's Phase I trial  

Successfully raised US$8.15 million in 2008 from institutional and private investors including Toucan Partners



Commenting on the results, Alton L. Boynton, Chief Executive of NWBT said:


'Since our listing on AIM in 2007, we have made significant progress on three fronts. First, our Phase II DCVax®-Brain clinical trial is operational  in the United States at 13 clinical centers. Secondly, Swissmedic is reviewing our MAA application and several successful inspections have occurred during the year. Thirdly, we continue to make progress in setting up  compassionate use programs outside the United States.  


With regard to our clinical programme, we have announced encouraging data from our key DCVax®-Brain trials, Phase I and Phase I/II trials, and they continue to show very positive survival data. Of particular significance, the median survival of patients treated with DCVax®-Brain has reached 36.4 months compared to patients treated with the standard of care at 17.1 months and 8 of the 20 patients are still alive having survived for periods between 25 and 97 months.' 


'We initiated an additional Phase I/II trial in recurrent ovarian cancer in the United States in December 2007 and announced the initial data on two patients completing the Phase I/II portion of the study in December 2008. The two patients who have received treatment [attained][reached?] 8 months and 6 months without progression, respectively. Each of these NWBT patients had metastases in 4 or 5 locations at the beginning of the trial and, in both of the patients, all of their metastatic lesions responded following the treatment regimen - either by shrinking somewhat (20-25%), or by remaining the same size and not growing, or by disappearing. The patients did not experience any toxicity or debilitating side effects.'



The Company remains in an advanced stage of negotiations with several different providers for additional near-term funding and longer term funding, which it hopes to complete during H1 of 2009. The Company will need to raise additional capital to fund its clinical trials and other operating activities and to repay indebtedness in due course. Shareholders should be aware that if the Company's capital raising efforts are unsuccessful, this will have a material adverse effect on the Company's financial position and operations.  The Company's independent auditors have indicated in their report of December 31, 2008 that there is a substantial doubt about Northwest's ability to continue as a going concern. See 'Management's Discussion and Analysis of Financial Condition and Results of Operations - Liquidity and Capital Resources' for additional information regarding our liquidity, cash flow and financing.



Detailed results are included in the Form 10-K as filed with the United States Securities and Exchange Commission ('SEC') on April 15, 2009 and can be viewed by at http://www.rns-pdf.londonstockexchange.com/rns/6471Q_1-2009-4-15.pdf 



For further information, please contact:


Northwest Biotherapeutics, Inc.


Alton Boynton, Chief Executive 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


Adrian Hadden / Adam Cowen

+44 (0)20 7523 8350





  

NORTHWEST BIOTHERAPEUTICS, INC

(A Development Stage Company)









Condensed Consolidated Statement of Operations

(in thousands, except for per share data)













Year Ended ended




December 31




2007


2008

Revenues


$

10 


$

10 









Operating expenses








Research and development



8,778 



12,703 


General and administrative



7,190 



8,928 


Total operating expenses


 

15,968 


 

21,631 









Loss from operations



(15,958)



(21,621)









Other income (expense)








Gain on sale of property plant and equipment







Interest income



340 



103 


Interest expense


 

(5,629)


 

(821)









Net income (loss)


$

(21,247)


$

(22,331)









Issuance of common stock in connection with elimination of preferred stock dividends 



(12,349)



-

Modification of preferred stock warrants



(18,699)



-

Preferred stock dividends



(1,251)



-

Warrants issued on preferred stock dividends



(4,664)



-









Net income (loss) loss applicable to common stockholders


$

(58,210)


$

(22,331)








Net income (loss) per common share - basic and diluted


$

(2.38)


$

(0.53)

Weighted average shares outstanding - basic and diluted


 

24,420 


 

42,425 



A detailed financial report including an analysis of operating results is included in Item 7, 'Management's Discussion and Analysis of Financial Condition and Results of Operations', of the Company's Annual Report as filed with the SEC on Form 10K and can be viewed at http://www.rns-pdf.londonstockexchange.com/rns/6471Q_1-2009-4-15.pdf.

 




NORTHWEST BIOTHERAPEUTICS, INC

(A Development Stage Company)








Condensed Consolidated Balance Sheet

(in thousands, except for per share data)











December 31, 



2007


2008



 

 


 

Current assets







Cash and short term investments

$

7,861 


$

16 


Prepaid and other current assets


823 



1,058 

Total current assets

 

8,684 


 

1,074 









Property and equipment, net


19 



394 


Deposit and other non-current assets




12 

Total other assets

 

22 


 

406 








Total assets

$

8,706 


$

1,480 








Current liabilities







Note payable to related party

$

-


$

6,047 


Current portion of capital lease obligations


-



1,454 


Accounts payable


1,007 



4,076 


Accrued expenses


1,892 



2,203 

Total current liabilities

 

2,899 


 

13,780 








Long term liabilities


-



-








Total liabilities

 

2,899 


 

13,780 








Stockholders' equity/(deficit)







Common stock


42



42


Additional paid-in capital


148,064



152,308


Accumulated deficit


(142,299)



(164,650)

Total stockholders' equity / (deficit)

 

5,807 


 

(12,300)








Total liabilities and stockholders' equity / (deficit)

$

8,706 


$

1,480 









This information is provided by RNS
The company news service from the London Stock Exchange
 
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