Financial Results
16 April 2009 - 8:00AM
UK Regulatory
TIDMNWBS TIDMNWBT
RNS Number : 6471Q
Northwest Biotherapeutics Inc
16 April 2009
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| 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
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| * | 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 |
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| * | In communication with Swissmedic with respect to the Marketing |
| | Authorization Application (MAA) that was submitted to the agency for |
| | marketing DCVax -Brain in Switzerland |
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| * | Worked with Cognate BioServices to expand manufacture capacity |
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| * | Reported two sets of long-term follow up data of DCVax -Brain Phase I and |
| | Phase I/II clinical trials |
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| * | Reported the Company's first clinical data from DCVax -L for ovarian |
| | cancer: first two patients who completed the Company's Phase I trial |
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| * | 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:
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| Northwest Biotherapeutics, Inc. | |
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| Alton Boynton, Chief Executive Officer | +1 240-497-9024 |
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| | |
+----------------------------------------------------------------+----------------------+
| Buchanan Communications | |
+----------------------------------------------------------------+----------------------+
| Lisa Baderoon (lisab@buchanan.uk.com) / Mary-Jane Johnson / | +44 (0)20 7466 5000 |
| Catherine Breen | |
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| | |
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| Collins Stewart Europe Limited | |
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| Adrian Hadden / Adam Cowen | +44 (0)20 7523 8350 |
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+----------+------------------------------------------------+----------+--+----------+----------+--+----------+
| 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 | | | | | | 8 |
+----------+------------------------------------------------+----------+--+----------+----------+--+----------+
| | Interest income | | | 340 | | | 103 |
+----------+------------------------------------------------+----------+--+----------+----------+--+----------+
| | Interest expense | | | (5,629) | | | (821) |
+----------+------------------------------------------------+----------+--+----------+----------+--+----------+
| | | | | | | | |
+----------+------------------------------------------------+----------+--+----------+----------+--+----------+
| Net income (loss) | | $| (21,247) | | $| (22,331) |
+-----------------------------------------------------------+----------+--+----------+----------+--+----------+
| | | | | | | | |
+----------+------------------------------------------------+----------+--+----------+----------+--+----------+
| Issuance of common stock in connection with elimination | | | (12,349) | | | - |
| of preferred stock dividends | | | | | | |
+-----------------------------------------------------------+----------+--+----------+----------+--+----------+
| 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.
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| |
+----------------------------------------------------------------------------------------------------------------------------------+
| |
+----------------------------------------------------------------------------------------------------------------------------------+
| | 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 3 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 | | | | | |
| | | | | | | |
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This information is provided by RNS
The company news service from the London Stock Exchange
END
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