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NORTHWEST BIOTHERAPEUTICS INC - Quarter Report: 2005 September (Form 10-Q)

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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
     
þ   QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For The Quarterly Period Ended September 30, 2005
OR
     
o   TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission File Number 0-26825
NORTHWEST BIOTHERAPEUTICS, INC.
(Exact Name Of Registrant As Specified In Its Charter)
     
DELAWARE
(State or Other Jurisdiction of
Incorporation or Organization)
  94-3306718
(I.R.S. Employer Identification
No.)
Canyon Park Building 8, 22322 20th Avenue S.E., Suite 150, Bothell, Wa. 98021
(Address of Principal Executive Offices, Including Zip Code)
(425) 608-3000
(Registrant’s Telephone Number, Including Area Code)
     Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes þ No o
     Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act). Yes o No þ
     Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No þ
     As of November 14, 2005, the registrant had outstanding 19,078,048 shares of common stock, $0.001 par value.
 
 


TABLE OF CONTENTS
NORTHWEST BIOTHERAPEUTICS, INC.
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 EXHIBIT 10.17
 EXHIBIT 10.18
 EXHIBIT 10.19
 EXHIBIT 10.20
 EXHIBIT 10.21
 EXHIBIT 10.22
 EXHIBIT 10.23
 EXHIBIT 10.24
 EXHIBIT 10.25
 EXHIBIT 10.26
 EXHIBIT 10.27
 EXHIBIT 10.28
 EXHIBIT 10.29
 EXHIBIT 31.1
 EXHIBIT 31.2
 EXHIBIT 32.1
 EXHIBIT 32.2

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Part I — Financial Information
Item 1. Financial Statements
NORTHWEST BIOTHERAPEUTICS, INC .
(A Development Stage Company)
Balance Sheets
(in thousands, unaudited)
                 
    December 31,     September 30,  
    2004     2005  
Assets
               
Current assets:
               
Cash
  $ 248     $ 301  
Accounts receivable
    11       22  
Accounts receivable, related party
          58  
Prepaid expenses and other current assets
    151       57  
 
           
Total current assets
    410       438  
 
           
Property and equipment:
               
Leasehold improvements
    69       69  
Laboratory equipment
    139       79  
Office furniture and other equipment
    104       117  
 
           
 
    312       265  
Less accumulated depreciation and amortization
    (194 )     (198 )
 
           
Property and equipment, net
    118       67  
Restricted cash
    30       30  
 
           
Total assets
  $ 558     $ 535  
 
           
Liabilities And Stockholders’ Equity
               
Current liabilities:
               
Note payable to related parties, net
  $ 3,226     $ 5,756  
Current portion of capital lease obligations
    38       15  
Accounts payable
    1,453       357  
Accounts payable, related party
          2,944  
Accrued expenses
    201       126  
Accrued expense, tax liability
    494       329  
Accrued expense, related party
    316       481  
Deferred grant revenue
    35        
 
           
Total current liabilities
    5,763       10,008  
Long-term liabilities:
               
Capital lease obligations, net of current portion
    12       4  
 
           
Total liabilities
    5,775       10,012  
 
           
Stockholders’ equity:
               
Preferred stock, $0.001 par value; 100,000,000 shares authorized and 32,500,000 shares issued and outstanding at September 30, 2005
          33  
Common stock, $0.001 par value; 300,000,000 shares authorized and 19,028,779 and 19,078,048 shares issued and outstanding at December 31, 2004 and September 30, 2005, respectively
    19       19  
Additional paid-in capital
    67,524       71,174  
Deferred compensation
    (7 )      
Deficit accumulated during the development stage
    (72,753 )     (80,703 )
 
           
Total stockholders’ equity
    (5,217 )     (9,477 )
 
           
Total liabilities and stockholders’ equity
  $ 558     $ 535  
 
           
See accompanying notes to condensed financial statements.

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NORTHWEST BIOTHERAPEUTICS, INC.
(A Development Stage Company)
STATEMENTS OF OPERATIONS
(in thousands, except per share data, unaudited)
                                         
                                    Period from  
    Three Months Ended     Nine Months Ended     March 18, 1996  
    September 30,     September 30,     (inception) to  
    2004     2005     2004     2005     September 30, 2005  
Revenues:
                                       
Research material sales
  $ 12     $ 4     $ 46     $ 23     $ 435  
Contract research and development from related parties
                            1,128  
Research grants, license fees, royalties
    79       11       288       87       1,062  
 
                             
Total revenues
    91       15       334       110       2,625  
 
                             
 
                                       
Operating expenses:
                                       
Cost of research material sales
    8       3       38       8       378  
Research and development
    1,716       1,252       2,102       3,860       31,455  
General and administrative
    629       634       1,880       1,554       30,243  
Depreciation and amortization
    35       13       109       52       2,255  
Accrued loss on facility sublease
                            895  
Asset impairment loss
    78             78             2,066  
 
                             
Total operating expenses
    2,466       1,902       4,207       5,474       67,292  
 
                             
Loss from operations
    (2,375 )     (1,887 )     (3,873 )     (5,364 )     (64,667 )
 
                             
 
                                       
Other income (expense):
                                       
Warrant valuation
    717             717             (368 )
Gain on sale of intellectual rights
                            3,656  
Interest expense
    (609 )     (896 )     (962 )     (2,589 )     (12,209 )
Interest income
    1       1       2       3       734  
 
                             
Net loss
    (2,266 )     (2,782 )     (4,116 )     (7,950 )     (72,854 )
 
                                       
Accretion of Series A preferred stock mandatory redemption obligation
                            (1,872 )
Series A preferred stock redemption fee
                            (1,700 )
Beneficial conversion feature of Series D preferred stock
                            (4,274 )
 
                             
Net loss applicable to common stockholders
  $ (2,266 )   $ (2,782 )   $ (4,116 )   $ (7,950 )   $ (80,700 )
 
                             
Net loss per share applicable to common stockholders — basic and diluted
  $ (0.12 )   $ (0.15 )   $ (0.22 )   $ (0.42 )        
 
                               
Weighted average shares used in computing basic and diluted loss per share
    19,026       19,078       19,026       19,064          
 
                               

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NORTHWEST BIOTHERAPEUTICS, INC.
(A Development Stage Company)
Condensed Statements of Cash Flows
(in thousands, unaudited)
                         
                    Period from  
    Nine Months Ended     March 18, 1996  
    September 30,     (Inception) to  
    2004     2005     September 30, 2005  
Cash Flows from Operating Activities:
                       
Net Loss
  $ (4,116 )   $ (7,950 )   $ (72,854 )
Reconciliation of net loss to net cash used in operating activities:
                       
Depreciation and amortization
    109       52       2,254  
Amortization of deferred financing costs
                320  
Amortization debt discount
    860       2,171       9,521  
Accrued interest converted to preferred stock
                260  
Accreted interest on convertible promissory note
    92       412       606  
Stock-based compensation costs
    33       10       1,093  
Loss (gain) on sale and disposal of property and equipment
          11       486  
Gain on sale of intellectual property and royalty rights
                (3,656 )
Gain on sale of property and equipment
    (36 )     (81 )     (217 )
Warrant valuation
    (717 )           368  
Asset impairment loss
    78             2,066  
Loss on facility sublease
                895  
Increase (decrease) in cash resulting from changes in assets and liabilities:
                       
 
                       
Accounts receivable
    (29 )     (69 )     (80 )
Prepaid expenses and other current assets
    60       94       409  
Accounts payable and accrued expenses
    366       1,776       4,638  
Accrued loss on sublease
                (266 )
Deferred grant revenue
    39       (35 )      
Deferred rent
    (11 )           410  
 
                 
Net Cash used in Operating Activities
    (3,272 )     (3,609 )     (53,747 )
 
                 
Cash Flows from Investing Activities:
                       
Purchase of property and equipment, net
          (13 )     (4,550 )
Proceeds from sale of property and equipment
    36       81       217  
Proceeds from sale of intellectual property
                1,816  
Proceeds from sale of marketable securities
                2,000  
Transfer of restricted cash
    75             (1,034 )
 
                 
Net Cash provided by (used in) Investing Activities
    111       68       (1,551 )
 
                 
Cash Flows from Financing Activities:
                       
Proceeds from issuance of note payable to stockholder
                1,650  
Repayment of note payable to stockholder
                (1,650 )
Proceeds from issuance of convertible promissory note and warrants, net of issuance costs
    3,100       2,400       12,149  
Borrowing under line of credit, Northwest Hospital
                2,834  
Repayment of line of credit, Northwest Hospital
                (2,834 )
Repayment of convertible promissory note
    (52 )     (54 )     (106 )
Payment on capital lease obligations
    (31 )     (32 )     (305 )
Payments on note payable
                (420 )
Proceeds from issuance Series A cumulative preferred stock, net
          1,276       28,708  
Proceeds from exercise of stock options and warrants
          4       224  
 
                       

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                    Period from  
    Nine Months Ended     March 18, 1996  
    September 30,     (Inception) to  
    2004     2005     September 30, 2005  
Proceeds from issuance common stock, net
                17,369  
Mandatorily redeemable Series A preferred stock redemption fee
                (1,700 )
Deferred financing costs
                (320 )
 
                 
Net Cash provided by Financing Activities
    3,017       3,594       55,599  
 
                 
Net increase (decrease) in cash and cash equivalents
    (144 )     53       301  
Cash and cash equivalents at beginning of period
    255       248        
 
                 
Cash and cash equivalents at end of period
  $ 111     $ 301     $ 301  
 
                 
Supplemental disclosure of cash flow information
                       
Cash paid during the period for interest
  $ 9     $ 5     $ 1,394  
 
                 
Supplemental schedule of non-cash financing activities
                       
Equipment acquired through capital leases
                285  
Common stock warrant liability
    2,863             4,714  
Accretion of mandatorily redeemable Series A preferred stock redemption obligation
                1,872  
Beneficial conversion feature of convertible promissory notes
    2,140       2,400       6,193  
Conversion of convertible promissory notes and accrued interest to Series D preferred stock
                5,324  
Issuance of Series C preferred stock warrants in connection with lease agreement
                43  
Issuance of common stock for license rights
                4  
Issuance of common stock and warrants to Medarex
                840  
Issuance of common stock to landlord
                35  
Deferred compensation on issuance of stock options and restricted stock grants
          10       762  
Cancellation of options and restricted stock
                849  
Stock subscription receivable
                480  
Financing of prepaid insurance through note payable
                420  
See accompanying notes to condensed financial statements.

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NORTHWEST BIOTHERAPEUTICS, INC.
(A Development Stage Company)
Notes to Condensed Financial Statements
(unaudited)
1. Basis of Presentation
     The accompanying unaudited financial statements for Northwest Biotherapeutics, Inc. (the “Company”) have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included. Operating results for the nine month period ended September 30, 2005 are not necessarily indicative of the results that may be expected for the year ending December 31, 2005.
     For further information, refer to the financial statements and footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2004, as filed with the Securities and Exchange Commission.
     The auditor’s report on the financial statements for the fiscal year ended December 31, 2004 states that because of recurring operating losses, a working capital deficit, and a deficit accumulated during the development stage, there is substantial doubt about the Company’s ability to continue as a going concern. A “going concern” opinion indicates that the financial statements have been prepared assuming the Company will continue as a going concern and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty.
Stock-Based Compensation
     The Company accounts for its stock option plans for employees in accordance with the provisions of Accounting Principles Board (APB) Opinion No. 25, Accounting for Stock Issued to Employees, and related interpretations. As such, compensation expense related to employee stock options is recorded if, on the date of grant, the fair value of the underlying stock exceeds the exercise price. The Company applies the disclosure-only requirements of SFAS No. 123, Accounting for Stock-Based Compensation, which allows entities to continue to apply the provisions of APB Opinion No. 25 for transactions with employees, and to provide pro-forma results of operations disclosures for employee stock option grants as if the fair-value-based method of accounting in SFAS No. 123 had been applied to those transactions.
     Stock compensation costs related to fixed employee awards with pro-rata vesting are recognized on a straight-line basis over the period of benefit, generally the vesting period of the options. For options and warrants issued to non-employees, the Company recognizes stock compensation costs utilizing the fair value methodology prescribed in SFAS No. 123 over the related period of benefit.
     Had the Company recognized the compensation cost of employee stock options based on the fair value of the options on the date of grant as prescribed by SFAS No. 123, the pro-forma net loss applicable to common stockholders and related loss per share would have been adjusted to the pro-forma amounts indicated in the following table:

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    Three months ended September 30,   Nine months ended September 30,
    (in thousands, except earnings per share)   (in thousands, except earnings per share)
    2004   2005   2004   2005
Net loss applicable to common stockholders as reported
    (2,266 )     (2,782 )     (4,116 )     (7,950 )
Add: Stock-based employee compensation expense included in reported net loss, net
    7       1       33       10  
Deduct: Stock-based employee compensation determined under fair value based method for all awards
    (95 )     (12 )     (329 )     (57 )
 
                               
Pro forma
    (2,354 )     (2,793 )     (4,412 )     (7,997 )
 
                               
Net loss per share-basic and diluted:
                               
As reported
    (0.12 )     (0.15 )     (0.22 )     (0.42 )
Pro forma
    (0.12 )     (0.15 )     (0.23 )     (0.42 )
     There were no stock options granted during the nine months ended September 30, 2004. The per share weighted average fair value of stock options granted during the nine months ended September 30, 2005 was $0.21. These weighted average fair values were determined on the dates of grants using the following weighted average assumptions:
         
    Nine months ended September 30, 2005
Risk-free interest rate
    2.46 %
Expected life
  5.0 years
Expected volatility
    439.19 %
Dividend yield
    0.00 %
2. Liquidity
      We have been and remain highly illiquid. As of September 30, 2005, the Company had unrestricted cash of approximately $301,000 and current liabilities of approximately $10.0 million.
     From February 2, 2004 through the nine months ended September 30, 2005, the Company has undergone a significant recapitalization pursuant to which Toucan Capital Fund II, L.P., or Toucan Capital, has loaned the Company $6.75 million. On January 26, 2005, the Company entered into a securities purchase agreement with Toucan Capital pursuant to which they purchased 32.5 million shares of the Company’s newly designated series A preferred stock at a purchase price of $0.04 per share, for a net purchase price of $1.276 million, net of issue related costs of approximately $24,000. These funds have enabled the Company to continue to operate, although at a very minimal level of activity, while attempting to raise additional capital.
     Our ability to obtain additional financing from Toucan Capital or anyone else is highly uncertain. Any additional equity financing is likely to be dilutive to stockholders, and any debt financing, if available, may include additional restrictive covenants. If the Company is unable to obtain significant additional capital in the near-term, the Company may cease operations at anytime. The Company believes that its assets would be insufficient to satisfy the claims of all of its creditors in full. Therefore, if the Company were to pursue liquidation, it is highly unlikely that its stockholders would receive any proceeds. There can be no assurance that the Company will be able to raise additional funds.
     The Company’s independent auditors have indicated in their report on the Company’s financial statements, included in the Company’s December 31, 2004 annual report on Form 10-K, that there is substantial doubt about the Company’s ability to continue as a going concern. The Company needs to raise significant additional funding to continue its operations, conduct research and development activities, pre-clinical studies and clinical trials necessary to bring its product candidates to market. However, additional funding may not be available on terms acceptable to the Company or at all. The alternative of issuing additional equity or convertible debt securities also may not be available and, in any event, would result in additional dilution to the Company’s stockholders.
3. Net Loss Per Share Applicable to Common Stockholders
     Basic net loss per share represents income available to common stock divided by the weighted-average number of shares of common stock outstanding during the period. Diluted net loss per share was the same as basic net loss per share for all periods presented since the effect of any potentially dilutive securities is excluded, as they are anti-dilutive due to the net loss being reported in the periods presented.
     For the three and nine months ended September 30, 2004, shares issuable upon exercise of options to acquire 919,488 shares of common stock, shares issuable upon exercise of warrants to acquire 91.0 million shares of common stock, and 82.0 million shares of common stock issuable upon the conversion of convertible debt and convertible subordinated debt, and 2,000 issued and outstanding restricted shares of common stock subject to repurchase were not included in the computation of diluted net loss per share as the effect would have been anti-dilutive.
     For the three and nine months ended September 30, 2005, shares issuable upon exercise of options to acquire 743,000 shares of common stock, shares issuable upon exercise of warrants to acquire 140.6 million shares of common stock, and 186.0 million shares of common stock issuable upon the conversion of convertible debt and convertible subordinated debt were not included in the computation of diluted net loss per share as the effect would have been anti-dilutive.
4. Notes Payable to Related Parties
Management Loans
     On November 13, 2003, the Company borrowed an aggregate of $335,000 from certain members of its management which enabled the Company to continue operating into the first quarter of 2004. Net of

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repayments, the aggregate loan principal liability remaining at September 30, 2005 is $235,000, as more fully described in the following table:
             
Lender   Title   Principal
Alton L. Boynton, Ph.D.
  Director, President, Chief Scientific Officer, Chief Operating Officer and Secretary   $ 183,000  
 
           
Marnix Bosch, Ph.D.
  Vice President of Vaccine Research and Development     41,000  
 
           
Larry L. Richards
  Controller (Principal Financial and Accounting Officer)     11,000  
 
           
 
           
 
  Total   $ 235,000  
 
           
     These loans initially had a 12-month term, accrue interest at an annual rate equal to the prime rate plus 2% and were initially secured by substantially all of the Company’s assets not otherwise collateralized. The aggregate principal amount of the original notes was $335,000 of which $50,000, including interest of $1,674, was repaid on June 1, 2004 and $50,000, including interest of $4,479, was repaid on February 24, 2005. In connection with the April 26, 2004 recapitalization agreement with Toucan Capital the notes were amended to set the conversion price at $0.10 per share and change the maturity date to November 12, 2004 in the event the Company raised at least $15 million in a financing prior to that time or May 12, 2005 if the Company had not completed a $15 million financing by May 12, 2005. The notes were further amended on April 12, 2005, June 16, 2005, July 26, 2005, and November 14, 2005 to extend the maturity dates of each such note and, as a result of the last amendment, the current maturity dates are January 31, 2006.
     As part of the November 13, 2003 loan, the lenders were issued warrants initially exercisable to acquire an aggregate of 3.7 million shares of the Company’s common stock, expiring November 2008, subject to certain antidilution adjustments, at an exercise price to be determined as follows: (i) in the event that the Company completes an offering of its common stock generating gross proceeds of at least $1 million, then the price per share paid by investors in that offering; or (ii) if the Company does not complete such an offering, then $0.18, which was the closing price of its common stock on the date of the financing, November 13, 2003. In connection with the April 26, 2004 recapitalization agreement between the Company and Toucan Capital, the warrants were amended to remove the anti-dilution provisions and set the warrant exercise price at the lesser of (i) $0.10 per share or (ii) a 35% discount to the average closing price during the twenty trading days prior to the first closing of the sale by the Company of convertible preferred stock as contemplated by the recapitalization agreement but not less than $0.04 per share.
     Proceeds from this loan were allocated between the notes and warrants on a relative fair value basis. The value allocated to the warrants on the date of the grant was approximately $221,000. The fair value of the warrants was determined using the Black-Scholes option pricing model with the following assumptions: expected dividend yield of 0%, risk-free interest rate of 3.36%, volatility of 194%, and a contractual life of 5 years. The value of the warrants was recorded as a deferred debt discount against the $335,000 proceeds of the notes. In addition, a beneficial conversion feature related to the notes was determined to be approximately $221,000 but is capped at the remaining value originally allocated to the notes of approximately $114,000. As a result, the total discount on the notes equaled the face value of $335,000, which was fully amortized by December 31, 2004.
     Toucan Capital Loans
     On April 26, 2004 the Company entered into a recapitalization agreement with Toucan Capital, which contemplates the possible recapitalization of the Company. The Company and Toucan Capital amended and restated the recapitalization agreement on July 30, 2004 (as so amended and restated the “Recapitalization Agreement”). The Company and Toucan Capital amended the Recapitalization Agreement on October 22, 2004, November 10, 2004, December 27, 2004, January 26, 2005, April 12,

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2005, May 13, 2005, June 16, 2005, July 26, 2005, September 7, 2005, and November 14, 2005. The November 14, 2005 amendment (i) updated certain representations and warranties of the parties made in the Recapitalization Agreement, and (ii) made certain technical changes in the Recapitalization Agreement in order to facilitate the November 14, 2005 bridge loan described herein.
     At Toucan Capital’s option, and if successfully implemented, the recapitalization could provide the Company with up to $40 million through the issuance of new securities to Toucan Capital and a syndicate of other investors. The sixth amendment, dated July 26, 2005, to amend and restate the binding term sheet extended subsequent closings of the convertible preferred stock to December 31, 2006, or such later date as is mutually agreed by the Company and Toucan Capital. Following the recapitalization, Toucan Capital and the investor syndicate would potentially own, on a combined basis, over 95% of the Company’s outstanding capital stock. As part of the Company’s recapitalization plan the Company borrowed an aggregate $6.75 million from Toucan Capital, from February 2, 2004 through September 30, 2005, pursuant to a series of convertible promissory notes comprised of the following transactions:
                                         
Loan Date   Principal(6)     Due Date     Accrued Interest (1)     Convertible Shares     Shares Warrant  
    (In thousands)             (In thousands)     (In thousands)     (In thousands) (2)(3)  
02/02/04
  $ 50       01/17/06     $ 9       1,466       3,000 (4)
03/01/04
    50       01/17/06       8       1,455       3,000 (4)
04/26/04
    500       01/17/06       74       14,341       30,000 (4)
06/11/04
    500       01/17/06       67       14,168       30,000 (4)
07/30/04
    2,000       01/17/06       237       55,933       20,000 (5)
10/22/04
    500       01/17/06       47       13,675       5,000 (5)
11/10/04
    500       01/17/06       44       13,610       5,000 (5)
12/27/04
    250       01/17/06       19       6,724       2,500 (5)
04/12/05
    450       04/12/06       21       11,774       4,500 (5)
05/13/05
    450       05/13/06       17       11,681       4,500 (5)
06/16/05
    500       06/16/06       15       12,866       5,000 (5)
07/26/05
    500       07/26/06       9       12,725       5,000 (5)
09/07/05
    500       09/07/06       3       12,579       5,000 (5)
 
                               
Total
  $ 6,750             $ 570       182,997       122,500  
 
                               
 
(1)   As of September 30, 2005. Interest accrues at 10% per annum based on a 365-day basis compounded annually from their respective original issuance dates.
 
(2)   The warrant shares are exercisable for shares of convertible preferred stock if the convertible preferred stock is approved and authorized and other investors have purchased in cash a minimum of $15 million of such convertible preferred stock, on the terms and conditions set forth in the Recapitalization Agreement. However, if, for any reason, such convertible preferred stock is not approved or authorized and/or if other investors have not purchased in cash a minimum of $15 million of such convertible preferred stock, on the terms and conditions set forth in the Recapitalization Agreement, these warrants shall be exercisable for any equity security and/or debt security and/or any combination thereof.
 
(3)   Exercise period is 7 years from the issuance date of the corresponding convertible note, except for the warrants corresponding to the February 2, 2004 and March 1, 2004 warrants which were issued on April 26, 2004 and are exercisable through April 26, 2011.
 
(4)   Per share exercise price is $0.01 (subject to adjustment in the event of stock splits, reverse stock splits, stock dividends, dilutive events and the like).
 
(5)   Per share exercise price is $0.04 (subject to adjustment in the event of stock splits, reverse stock splits, stock dividends, dilutive events and the like).
 
(6)   The notes are secured by a first priority senior security interest in all of the Company’s assets.
5. Unregistered Sales of Equity Securities
Toucan Capital Series A Cumulative Convertible Preferred Stock
     On January 26, 2005, the Company entered into a securities purchase agreement with Toucan Capital pursuant to which it purchased 32.5 million shares of the Company’s newly designated series A preferred stock at a purchase price of $0.04 per share, for a purchase price of $1.276 million, net of issue related costs of approximately $24,000. The series A preferred stock:
(i)   is entitled to cumulative dividends at the rate of 10% per year;
 
(ii)   is entitled to a liquidation preference in the amount of its initial purchase price plus all accrued and unpaid dividends (to the extent of legally available funds);
 
(iii)   has a preference over the common stock with respect to dividends and distributions;
 
(iv)   is entitled to participate on an as-converted basis with the common stock on any distributions after the payment of any preferential amounts to the series A stock;
 
(v)   votes on an as converted basis with the common stock on matters submitted to the common stockholders for approval and as a separate class on certain other material matters; and
 
(vi)   is convertible into common stock on a one-for-one basis (subject to adjustment in the event of stock dividends, stock splits, reverse stock splits, recapitalizations, etc.).
     The number of shares of common stock issuable upon conversion of each share of series A preferred stock is also subject to increase in the event of certain dilutive issuances in which the Company sells or is deemed to have sold shares below the then applicable conversion price (currently $0.04 per share). The consent of the holders of a majority of the series A preferred stock is required in the event that the Company elects to undertake certain significant business actions.

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Toucan Capital Series A Warrant
     On January 26, 2005, the Company issued Toucan Capital a warrant, with a contractual life of 7 years, to purchase 13.0 million shares of series A preferred stock, on a 1-for-1 basis, with an exercise price of $0.04 per share, in connection with Toucan Capital’s purchase of series A preferred stock on January 26, 2005. The number of shares issuable pursuant to the exercise of the warrant and the exercise price thereof is subject to adjustment in the event of stock splits, reverse stock splits, stock dividends, dilutive events and the like.
6. Contingency
     Beginning on October 9, 2002, the Company initiated a series of substantial steps to conserve cash, including the relocation and consolidation of its facilities on which use tax payments to the State of Washington had been deferred, including the disposal and impairment of previously qualified tax deferred equipment. The Company received a tax assessment of $492,000 on October 21, 2003 related to the abandonment of tenant improvements at the prior facility. The Company appealed the assessment and it was reduced to approximately $322,000 through the nine months ended September 30, 2005. The net assessment of approximately $329,000, inclusive of accrued interest, is being carried as an estimated liability on the Company’s balance sheet and is included in general and administrative expense. The Company expects its appeal will finalize by the end of 2005 with payment of the approximately $329,000 assessment becoming due by December 31, 2005.
     In February 2004, on a completely separate tax matter, the Company filed a refund request of approximately $175,000 related to certain other state taxes previously paid to the State of Washington’s Department of Revenue. The finalization of this refund request is not expected until late 2005. The Company may not be successful in its efforts to receive a tax refund.
7. Subsequent Events
     On November 14, 2005, the Company borrowed $400,000 from Toucan Partners, L.L.C., a designee and affiliated company of Toucan Capital Fund II, L.P., and, in connection with the loan, issued Toucan Partners, L.L.C. a warrant to purchase up to 4.0 million shares of its capital stock. The warrant, with a contractual life of 7 years, has an exercise price of $0.04 per share. The number of shares issuable pursuant to the exercise of the warrant and the exercise price thereof is subject to adjustment in the event of stock splits, reverse stock splits, stock dividends, dilutive events and the like.

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Item. 2. Management’s Discussion and Analysis of Financial Condition and Result of Operations
     The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our financial statements and the notes to those statements included with this report. In addition to historical information, this report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those projected. The words “believe,” “expect,” “intend,” “anticipate,” and similar expressions are used to identify forward-looking statements, but some forward-looking statements are expressed differently. Many factors could affect our actual results, including those factors described under “Factors That May Affect Results of Operations and Financial Condition.” These factors, among others, could cause results to differ materially from those presently anticipated by us. You should not place undue reliance on these forward-looking statements.
Overview
     We are a development stage biotechnology company focused on discovering, developing, and commercializing immunotherapy products that are expected to safely generate and enhance immune system responses to effectively treat cancer. Our primary activities since incorporation have been focused on advancing a proprietary dendritic cell immunotherapy for prostate and brain cancer together with strategic and financial planning, and raising capital to fund our operations. We completed an initial public offering of our common stock in December 2001.
     Since 2002, we have only been able to obtain enough capital resources to pursue our strategic plans at a very minimal level. We presently have approval from the U.S. Food and Drug Administration, or FDA, to conduct a Phase III trial for DCVax-Prostate, our product candidate for a possible prostate cancer treatment and a Phase II clinical trial to evaluate our DCVax-Brain product candidate as a possible treatment for Glioblastoma Multiforme. However we do not presently have adequate resources to conduct either of those trials.
     From February 2004 to November 14, 2005 we have undergone a significant recapitalization pursuant to which Toucan Capital and its affiliate Toucan Partners, L.L.C. have loaned us an aggregate of $7.15 million and Toucan Capital invested $1.276 million, net of issue related costs of approximately $24,000, in return for convertible debt securities, preferred stock and warrants. These funds have enabled us to continue to operate, although at a very minimal level of activity, while attempting to raise additional capital.
Critical Accounting Policies and Estimates
     Accounting principles generally accepted in the United States of America require our management to make estimates and assumptions that affect the amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of our financial statements, as well as the amounts of revenues and expenses during periods covered by our financial statements. The actual amounts of these items could differ materially from those estimates.
     We also determine our employee stock option compensation costs as the difference between the estimated fair value of our common stock and the exercise price of options on their date of grant. Prior to our initial public offering, our common stock was not actively traded. The fair value of our common stock for purposes of determining compensation expense for this period was determined based on our review of the primary business factors underlying the value of our common stock on the date such option grants were made, viewed in light of the expected initial public offering price per share prior to the initial public offering of our common stock. The actual initial public offering price was significantly lower than the expected price used in determining compensation expense. Also, on an ongoing basis the estimate of expense for stock options and warrants is dependant on factors such as expected life and volatility of our stock. To the extent actual expense is different than that estimated, the actual expense that would have been recorded may be substantially different.
     In December 2004, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards No. 123 (revised 2004), (SFAS 123R), “Share-Based Payment.” Effective with our fiscal year ending December 31, 2006, SFAS 123R requires the measurement of cost of employee services received in exchange for an award of an equity instrument, such as stock options, based on the grant-date fair-value of the award. The associated cost must be recognized over the period during which an employee is required to provide service in exchange for the award (usually the vesting period). SFAS 123R provides for a variety of implementation alternatives, including accounting for the change prospectively or restating previously reported amounts to reflect the compensation expense that would have been recorded under SFAS 123R. We are in the process of determining the impact of SFAS 123R on our financial statements, including which implementation alternative we will select.
     SFAS No. 151, “Inventory Costs, an amendment of ARB No. 43” Chapter 4 deals with inventory pricing with respect to abnormal amounts of idle facility expenses, freight, handling costs, and spoilage. Management is analyzing the requirements of this new Statement and believes that its adoption will not have any significant impact on our financial statements.
     SFAS No. 153, “Exchanges of Non-monetary Assets, amends Opinion 29” to eliminate the exception for non-monetary exchanges of similar productive assets and replaces it with a general exception for exchanges of non-monetary assets that do not have commercial substance. Management is analyzing the requirements of this new standard and believes that its adoption will not have any significant impact on our financial statements.
     FIN No. 46(R) revised FIN No. 46, “Consolidation of Variable Interest Entities” requiring the consolidation by a business of variable interest entities in which it is the primary beneficiary. The adoption of FIN No. 46 did not have an impact on our financial statements.
     The Emerging Issues Task Force (“EITF”) reached consensus on Issue No. 03-1, “The Meaning of Other-Than-Temporary Impairment and Its Application to Certain Investments” (“EITF 03-1”) which provides guidance on determining when an investment is considered impaired, whether that impairment is other than temporary and the measurement of an impairment loss. The FASB issued FSP EITF 03-1-1, “Effective Date of Paragraphs 10-20 of EITF Issue No. 03-1, ‘The Meaning of Other-Than-Temporary Impairment and Its Application to Certain Investments”, which delays the effective date for the measurement and recognition criteria contained in EITF 03-1 until final application guidance is issued. We do not expect the adoption of this consensus or FSP to have a material impact on our financial statements.
     The EITF reached a consensus on Issue No. 04-8, “The Effect of Contingently Convertible Debt on Diluted Earnings Per Share” (“EITF 04-8”), which addresses when the dilutive effect of contingently convertible debt instruments should be included in diluted earnings (loss) per share. EITF 04-8 is effective for reporting periods ending after December 15, 2004. The adoption of EITF 04-8 did not have an impact on diluted earnings (loss) per share since the effect of any potentially excluded dilutive securities is anti-dilutive due to the net loss being reported in the periods presented.

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Results of Operations
Operating costs:
     Operating costs and expenses consist primarily of research and development expenses, including clinical trial expenses which rise when we are actively participating in clinical trials, and general and administrative expenses.
Research and development:
     Discovery and preclinical research and development expenses include scientific personnel related salary and benefit expenses, costs of laboratory supplies used in our internal research and development projects, travel, regulatory compliance, and expenditures for preclinical and clinical trial operation and management when we are actively engaged in clinical trials.
     Because we are a development stage company we do not allocate research and development costs on a project basis. We adopted this policy, in part, due to the cost burden associated with accounting at such levels of detail and our limited number of resources. We shifted our focus, starting in 2002, from discovering, developing, and commercializing immunotherapy products to conserving cash and primarily concentrating on securing new working capital to re-activate our two clinical trial programs. Our business judgment continues to be that there is little value associated with evaluating project expenditure levels since all projects had either been discontinued and/or their respective activity reduced to a subsistence level. As research and development increased in 2004 and 2005, we continued not to track costs on a project basis due to continued resource constraints.
     For the nine months ended September 30, 2005, of our net loss of approximately $7.9 million, approximately 48% of our expended resources were apportioned to the re-activation of our DCVax-Brain protocol and our DCVax-Prostate protocol. From our inception through September 30, 2005, we incurred costs of approximately $31.5 million associated with our research and development activities. Because our technologies are unproven, we are unable to estimate with any certainty the costs we will incur in the continued development of our product candidates for commercialization.
General and administrative:
     General and administrative expenses include administrative personnel related salary and benefit expenses, cost of facilities, insurance, travel, legal support, property and equipment depreciation, amortization of stock options and warrants, and amortization of debt discounts and beneficial conversion costs associated with our debt financing.
Three Months Ended September 30, 2004 and 2005
     Total Revenues. Revenues decreased 84% from $91,000 for the three months ended September 30, 2004 to $15,000 for the three months ended September 30, 2005. The research material sales component of revenue decreased 67% from $12,000 for the three months ended September 30, 2004 to $4,000 for the three months ended September 30, 2005 due to the fact that we are not actively pursuing such sales. Research grant, license fees, and royalty income decreased 86% from $79,000 for the three months ended September 30, 2004 to $11,000 for the three months ended September 30, 2005. This decrease was primarily due to a decrease in grant revenue attributable to the cessation of the remaining two research grant awards during the first quarter of 2005.
     Cost of Research Material Sales. Cost of research material sales decreased 63% from $8,000 for the three months ended September 30, 2004 to $3,000 for the three months ended September 30, 2005. Lower sales volume resulted primarily from a lack of direct advertising in select trade journals in the first three quarters of 2005.
     Research and Development Expense. Research and development expense decreased 24% from $1.7 million for the three months ended September 30, 2004 to $1.3 million for the three months ended September 30, 2005. The decrease for the three months ended September 30, 2005 was primarily due to lower activity levels for consultant protocol and regulatory review, less interaction with the FDA, and a gradual slowing of the activity level pertaining to research and development related to preclinical activities and re-implementation of the manufacturing process for future clinical trial vaccines. The lack of adequate cash resources to pursue these activities at a preferred level is the primary reason for this decrease. Until we are able to secure more stable sources of funding, our ability to initiate the restart of any clinical trial will be severely hampered.

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     General and Administrative Expense. General and administrative expense increased 8% from $629,000 for the three months ended September 30, 2004 to $634,000 for the three months ended September 30, 2005. This increase was primarily due to ongoing costs associated with implementation of the recapitalization plan.
     Depreciation and Amortization. Depreciation and amortization decreased 63% from $35,000 the three months ended September 30, 2004 to $13,000 for the three months ended September 30, 2005. This decrease was primarily due to the disposal or impairment of $337,000 of property and equipment in the third and fourth quarters 2004.
     Asset Impairment Loss. Asset impairment loss incurred in the three months ended September 30, 2004 of $78,000 was primarily a result of entering into a service agreement with Cognate Therapeutics, Inc. in the third quarter of 2004 causing certain equipment to become underutilized as of September 30, 2004. There was no corresponding asset impairment loss during the three months ended September 30, 2005.
     Total Other Income (Expense), Net. Interest expense increased 47% from $609,000 for the three months ended September 30, 2004 to $896,000 for the three months ended September 30, 2005. This increase was due primarily to recognizing interest expense relative to the debt discount and interest accretion associated with the secured convertible promissory notes and warrants debt financing and the increased indebtedness outstanding during the three months ended September 30, 2005.
     Interest income of $1,000 for the three months ended September 30, 2004 and 2005 remained relatively constant due to having comparable average cash balances for the respective three months in 2004 and 2005.
     Warrant valuation, a non-cash transaction, decreased from $717,000 for the three months ended September 30, 2004 to $0.00 for the three months ended September 30, 2005 due to the change in the valuation of the common stock warrant liability. Total potential outstanding common stock exceeded our authorized shares on July 30, 2004 when an additional $2.0 million bridge loan, convertible into common stock, was received from Toucan Capital and additional warrants were issued. The fair value of the warrants in excess of the authorized shares was approximately $2.8 million and was recognized as a liability on July 30, 2004. This liability is required to be revalued at each reporting date with any change in value included in other income/(expense) until such time as enough shares are authorized to cover all potentially convertible instruments. Our stock price had declined from $0.04 at July 30, 2004 to $0.03 at September 30, 2004. The drop in stock price as of September 30, 2004 was the primary reason for a decrease in the fair value of the warrants and an increase in other income to us. There was no corresponding warrant evaluation during the three months ended September 30, 2005 as our stockholders, in our December 17, 2004 Annual Stockholders Meeting, approved an amendment to our Certificate of Incorporation increasing the number of shares that we were authorized to issue to 400 million shares as recorded with the Secretary of State of the state of Delaware on December 29, 2004.
Nine Months Ended September 30, 2004 and 2005
     Total Revenues. Revenues decreased 67% from $334,000 for the nine months ended September 30, 2004 to $110,000 for the nine months ended September 30, 2005. The research material sales component of revenue decreased 50% from $46,000 for the nine months ended September 30, 2004 to $23,000 for the nine months ended September 30, 2005. This lower sales volume resulted primarily from minimal direct advertising in select trade journals in the nine months ended September 30, 2005. Consequently, we expect a decreasing level of reagent sales through 2005 with these sales coming predominately from repeat orders. We are unable to project when, if ever, our sales of research materials will attain any consistent profitability.
     Research grant, license fees, and royalty income decreased 70% from $288,000 for the nine months ended September 30, 2004 to $87,000 for the nine months ended September 30, 2005. This decrease was primarily due to a decrease in grant revenue attributable to the cessation of the remaining two research grant awards during the first quarter of 2005.
     Cost of Research Material Sales. Cost of research material sales decreased 79% from $38,000 for the nine months ended September 30, 2004 to $8,000 for the nine months ended September 30, 2005.

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     Research and Development Expense. Research and development expense increased 86% from $2.1 million for the nine months ended September 30, 2004 to $3.9 million for the nine months ended September 30, 2005. Even though for the three months ended September 30, 2005 there was a slowing trend in research and development expenditures primarily attributable to low cash resources, overall for the nine months ended September 30, 2005 there has been increased activity over 2004 for consultant protocol and regulatory review, increased interaction with the FDA, increased research and development related to preclinical activities and re-implementation of the manufacturing process for future clinical trial vaccines. Until we are able to secure more stable sources of funding, our ability to initiate the restart of any clinical trial will be severely hampered.
     General and Administrative Expense. General and administrative expense decreased 16% from $1.9 million for the nine months ended September 30, 2004 to $1.6 million for the nine months ended September 30, 2005. This decrease was primarily due to continuing actions to conserve cash.
     Depreciation and Amortization. Depreciation and amortization decreased 52% from $109,000 the nine months ended September 30, 2004 to $52,000 for the nine months ended September 30, 2005. This decrease was primarily due to the disposal or impairment of $337,000 of property and equipment in the third and fourth quarters 2004.
     Asset Impairment Loss. Asset impairment loss incurred in the nine months ended September 30, 2004 of $78,000 was primarily a result of entering into a service agreement with Cognate Therapeutics, Inc. in the third quarter of 2004 causing certain equipment to become underutilized as of September 30, 2004. There was no corresponding asset impairment loss during the nine months ended September 30, 2005.
     Total Other Income (Expense), Net. Interest expense increased from $962,000 for the nine months ended September 30, 2004 to $2.6 million for the nine months ended September 30, 2005. This increase was due primarily to recognizing interest expense relative to the debt discount and interest accretion associated with the secured convertible promissory notes and warrant debt financing and the increased indebtedness outstanding during 2005.
     Interest income increased from $2,000 for the nine months ended September 30, 2004 to $3,000 for nine months ended September 30, 2005. This increase was primarily due to having higher comparable average cash balances during 2005.
     Warrant valuation, a non-cash transaction, decreased from $717,000 for the nine months ended September 30, 2004 to $0.00 for the nine months ended September 30, 2005 due to the change in the valuation of the common stock warrant liability. Total potential outstanding common stock exceeded our authorized shares on July 30, 2004 when an additional $2.0 million bridge loan, convertible into common stock, was received from Toucan Capital and additional warrants were issued. The fair value of the warrants in excess of the authorized shares was approximately $2.8 million and was recognized as a liability on July 30, 2004. This liability is required to be revalued at each reporting date with any change in value included in other income/(expense) until such time as enough shares are authorized to cover all potentially convertible instruments. Our stock price had declined from $0.04 at July 30, 2004 to $0.03 at September 30, 2004. The drop in stock price as of September 30, 2004 was the primary reason for a decrease in the fair value of the warrants and an increase in other income to us. There was no corresponding warrant evaluation during the three months ended September 30, 2005 as our stockholders, in our December 17, 2004 Annual Stockholders Meeting, approved an amendment to our Certificate of Incorporation increasing the number of shares that we were authorized to issue to 400 million shares as recorded with the Secretary of State of the state of Delaware on December 29, 2004.
Liquidity and Capital Resources
     We continue to be in the position of not having, and do not have access to, sufficient sources of funds to meet all of our anticipated operating and capital expenditure needs on a daily basis. Even with the series of loans from Toucan Capital and its affiliates, we have only been able to pay most vendor invoices within a 30 to 60 day time period.
     Unpaid invoices exceeding 60 days, through the nine months ended September 30, 2005, in the approximate amount of $2.2 million (inclusive of estimated late payment fees of approximately $140,000), pertain to Cognate Therapeutics, Inc, a related party, as disclosed on our balance sheet. The other major

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categories of unpaid invoices over 60 days, relate to general legal counsel, approximately $10,000, and patent counsel, approximately $87,000 that likewise are unpaid through the nine months ended September 30, 2005.
     In addition, we have (i) an aggregate of $4.35 million in notes (plus accrued interest) from Toucan Capital maturing January 17, 2006 and $2.4 million (plus accrued interest) maturing thereafter, and $400,000 maturing thereafter from Toucan Partners, L.L.C., (ii) $235,000 (plus accrued interest) from members of management maturing January 31, 2006, (iii) a net assessed tax liability to the State of Washington of approximately $329,000 with payment of the assessment expected to be due by December 31, 2005, (iv) capital lease obligations of approximately $20,500 as of September 30, 2005, (v) approximately $92,000 of earned and accrued but unpaid vacation and sick pay due employees through the nine months ended September 30, 2005, and (vi) an estimated liability due Toucan Capital, a related party, as disclosed on our balance sheet, of approximately $481,000 for their incurred cost, through the nine months ended September 30, 2005, in expenses that it has incurred, and which we have agreed to reimburse it, in connection with our recapitalization plan, including the financing it has provided to us.
     Low liquidity has made it necessary to slow payment of vendor invoices as revealed by our trade payables as of September 30, 2005, aged as follows:
         
Aged Trade Payables   (in thousands)  
 
Current:
  $ 271  
15 Days
    335  
30 Days
    75  
45 Days
    321  
60 Days
    2,299  
 
 
       
Total
    3,301  
     Through the nine months ended September 30, 2005, no vendors have requested a cash prepayment prior to delivering materials although they may require this condition at anytime. Regardless of whether an immediate demand for payment of any of these obligations is made, we will have to seek additional funds from Toucan Capital, which Toucan Capital is not obligated to provide us.
     From February 2, 2004 through November 14, 2005, we have undergone a significant recapitalization pursuant to which Toucan Capital and its affiliate Toucan Partners, L.L.C., have loaned us an aggregate of $7.15 million. On January 26, 2005, we entered into a securities purchase agreement with Toucan Capital pursuant to which they purchased 32.5 million shares of its newly designated series A preferred stock at a purchase price of $0.04 per share, for a net purchase price of $1.276 million, net of issue related costs of approximately $24,000. These funds have enabled us to continue to operate, although at a very minimal level of activity, while attempting to raise additional capital.
     On November 14, 2005 we amended and restated the promissory notes dated February 2, 2004, March 1, 2004, April 26, 2004, June 11, 2004, July 30, 2004, October 22, 2004, November 10, 2004, and December 27, 2004 between us and Toucan Capital, changing the maturity dates of each respective loan to January 17, 2006.
     Toucan Capital indicated in its Schedule 13D/A filed with the Securities and Exchange Commission on September 13, 2005 that it does not presently intend to provide further funding to us, although it indicated that one or more affiliates and/or designees may provide funding to us in the future. One such designee and affiliate, Toucan Partners, L.L.C., provided us with $400,000 of financing on November 14, 2005. There can be no assurance that we will be able to raise additional funds from Toucan Capital, Toucan Partners, L.L.C. or any other designee or affiliate of Toucan Capital or from any other source.
     Three transactions comprise 98% of the aggregate receivables disclosed on our balance sheet of approximately $80,000 due as of September 30, 2004. Equipment sold to Cognate Therapeutics, Inc. on March 31, 2005, a related party, as disclosed on our balance sheet, was for approximately $58,000, all of which remains unpaid as of September 30, 2005. Our insurance broker gave notice in May 2005 that we were entitled to receive a class action business insurance settlement of approximately $13,500 which was received on November 4, 2005. The third item of approximately $6,900, representing a refund of sales and use tax from the State of California, was received on October 24, 2005.

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     Gains on the sale of previously impaired equipment to third parties, in addition to the approximate $52,000 gain on previously impaired equipment sold to Cognate, were approximately $29,000, for an aggregate of $81,000, for the nine months ended September 30, 2005. The remaining equipment we own, if subsequently sold, is not expected to generate much cash.
     Beginning on October 9, 2002, we initiated a series of substantial steps to conserve cash, including the relocation and consolidation of our facilities on which use tax payments to the State of Washington had been deferred, including the disposal and impairment of previously qualified tax deferred equipment. We received a tax assessment of $492,000 on October 21, 2003 related to the abandonment of tenant improvements at the prior facility. We appealed the assessment and it was reduced to approximately $322,000 through the nine months ended September 30, 2005. The net assessment of approximately $329,000, inclusive of accrued interest, is being carried as an estimated liability on our balance sheet and is included in general and administrative expense. We expect our appeal will finalize by the end of 2005 with payment of the approximately $329,000 assessment becoming due by December 31, 2005.
     In February 2004, on a completely separate tax matter, we filed a refund request of approximately $175,000 related to certain other state taxes previously paid to the State of Washington’s Department of Revenue. The finalization of this refund request is not expected until late 2005. We may not be successful in its efforts to receive a tax refund.
     Our financial statements for the year ended December 31, 2004 and for the nine months ended September 30, 2005 were prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities in the normal course of business. Nevertheless, we have experienced recurring losses from operations since inception, have a working capital deficit of $9.6 million, and have a deficit accumulated during the development stage of $80.7 million, as of September 30, 2005, that raises substantial doubt about our ability to continue as a going concern.
     Our independent auditors have indicated in their report on our financial statements, included in our December 31, 2004 annual report on Form 10-K, that there is substantial doubt about our ability to continue as a going concern. We need to raise significant additional funding to continue our operations, conduct research and development activities, pre-clinical studies and clinical trials necessary to bring our product candidates to market. However, additional funding may not be available on terms acceptable to us or at all. The alternative of issuing additional equity or convertible debt securities also may not be available and, in any event, would result in additional dilution to our stockholders.
Sources of Cash
     Federal Grants
     On April 8, 2003, we were awarded a NIH cancer research grant. The total first year grant award was approximately $318,000, was earned under the grant, and was recognized in revenue through the year ended December 31, 2003. The total award for fiscal 2004-2005 was approximately $328,000, comprised of approximately $198,000 authorized for direct grant research expenditures and approximately $130,000 authorized for use to cover our facilities and administrative overhead costs. This grant’s remaining $35,000 award was recognized in January 2005. This grant ended January 31, 2005.
     Effective September 10, 2004, we were awarded a small business innovation research grant. The grant award for $100,000 had an award period that commenced September 10, 2004. There was approximately $59,000 earned under the grant and recognized in revenue through the year ended December 31, 2004. The remaining $41,000 of the grant’s aggregate award was recognized through the three months ended March 31, 2005.
     Research Reagent Sales
     On April 21, 2003, we announced our entry into the research reagents market. We earned approximately $23,000 in revenue for the nine months ended September 30, 2005 from the manufacture and sale of research materials. We are no longer actively promoting such sales.

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     License Fees
     Our effort to license certain rights, title, and interest to technology relating to the worldwide use of specific antibodies for the diagnostic immunohistochemical market resulted in the July 1, 2003 license agreement with DakoCytomation California, Inc. with the payment of a one-time $25,000 license fee and future non-refundable minimum annual royalty payments of $10,000 credited against any royalty payments made to us. The $10,000 July 2005 annual royalty payment was recognized as revenue on August 1, 2005 while a $585 royalty payment on certain product sales was recognized as revenue on July 25, 2005.
Management Loan
     On November 13, 2003, we borrowed an aggregate of $335,000 from certain members of our management. The notes accrue interest at an annual rate equal to the prime rate plus 2% and were originally (i) payable by July 12, 2005 and (ii) secured by substantially all of our assets not otherwise collateralized. We repaid $50,000, including interest of $1,674, on June 1, 2004 and repaid an additional $50,000, including interest of $4,497, on February 24, 2005. The notes were amended on April 26, 2004, April 12, 2005, June 16, 2005, July 26, 2005 and amended on November 14, 2005 to extend the maturity date of the three remaining notes to January 31, 2006.
     As part of the management loan, the lenders were issued warrants initially exercisable to acquire an aggregate of 3.7 million shares of our common stock, expiring November 2008 subject to certain antidilution adjustments, at an exercise price to be determined as follows: (i) in the event that we completed an offering of our common stock generating gross proceeds to us of at least $1 million, then the price per share paid by investors in that offering; or (ii) if we did not complete such an offering, then $0.18, which was the closing price of our common stock on the date of the financing. In connection with our April 26, 2004 recapitalization agreement these warrants were amended to remove the anti-dilution provisions and set the warrant exercise price at the lesser of (i) $0.10 per share or (ii) a 35% discount to the average closing price during the twenty trading days prior to the first closing of the sale by us of convertible preferred stock as contemplated by the recapitalization agreement but not less than $0.04 per share.
Toucan Capital Loans
     From February 2, 2004 through September 30, 2005, we have issued thirteen promissory notes to Toucan Capital pursuant to which Toucan Capital has loaned us an aggregate of $6.75 million. On November 14, 2005, we issued a promissory note to Toucan Partners, L.L.C. pursuant to which Toucan Partners, L.L.C. loaned us an aggregate of $400,000.
     Toucan Capital Series A Cumulative Convertible Preferred Stock
     On January 26, 2005 Toucan Capital purchased 32.5 million shares of our newly designated series A preferred stock at a purchase price of $0.04 per share, for an purchase price of $1.276 million, net of issue related costs of approximately $24,000.
Uses of Cash
     We used $3.3 million in cash for operating activities during the nine months ended September 30, 2004, compared to $3.6 million for the nine months ended September 30, 2005. For the nine months ended September 30, 2005, the change reflects increased utilization of consultants for regulatory advice and protocol review, increased costs associated with identifying future clinical trial sites, research and development expenditures related to preclinical activities, and gradual re-implementation of the manufacturing process for clinical trial vaccines.
     We generated $111,000 in cash from investing activities during the nine months ended September 30, 2004 compared to $68,000 provided by investing activities during the nine months ended September 30, 2005. The cash provided during the nine months ended September 30, 2005 is net of the aggregate $81,000 of proceeds from the sale of equipment and $13,000 in expenditures for computer equipment.
     We generated $3.0 million in cash from financing activities for the nine months ended September 30, 2004 primarily from the February 2 through July 30, 2004 loans from Toucan Capital. We generated $3.6 million in cash from financing activities during the nine months ended September 30, 2005 consisting of the January 26, 2005 securities purchase agreement with Toucan Capital pursuant to which they

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purchased 32.5 million shares of our newly designated series A preferred stock at a purchase price of $0.04 per share, for a net purchase price of $1.276 million, net of issue related costs of approximately $24,000, and loans in the aggregate amount of $2.4 million from Toucan Capital.
Factors That May Affect Results of Operations and Financial Condition
     This section briefly discusses certain risks that should be considered by our stockholders and prospective investors. You should carefully consider the risks described below, together with all other information included in our annual report on Form 10-K for the year ended December 31, 2004 and the information incorporated by reference. If any of the following risks actually occur, our business, financial condition, or operating results could be harmed. In such case, you could lose all of your investment.
     Without committed long-term financing, we will be unable to initiate our clinical trials.
     Our limited cash resources coupled with our inability to secure a long-term stable source of financing are factors slowing our ability to immediately construct the clinical trial infrastructure necessary to move aggressively forward with our newly approved FDA Phase III trial for prostate cancer and our Phase II trial for Glioblastoma Multiforme. Without committed long-term financing, we are unable to enter into contractual relationships with potential clinical trial sites that will process patients through our trial protocols. Sites may withdraw their initial willingness to work with us if we are not able, within a reasonable time based upon their assessment, to commit to upfront “good faith” initial payments that will enable them to move forward in seeking their respective Institutional Review Boards (IRB) approval to participate in our protocol as well as providing them the initial funds they need to construct their respective infrastructures to fulfill their contractual obligations to us. To the extent that additional time elapses before more stable financing is obtained, if obtainable, the further out in time it will be before end result clinical trial statistical data will be obtained further extending the time to product candidate commercialization, if we are ever able to commercialize a product candidate.
     We will need to raise additional capital which may not be available.
     We continue to be in the position of not having, and do not have access to, sufficient sources of funds to meet all of our anticipated operating and capital expenditure needs on a daily basis. Even with the series of loans from Toucan Capital and affiliates, we have only been able to pay most vendor invoices within a 30 to 60 day time period.
     Unpaid invoices exceeding 60 days, through the nine months ended September 30, 2005, in the approximate amount of $2.2 million (inclusive of estimated late payment fees of approximately $140,000), pertain to Cognate Therapeutics, Inc, a related party, as disclosed on our balance sheet. The other major categories of unpaid invoices over 60 days, relate to general legal counsel, approximately $10,000, and patent counsel, approximately $87,000 that likewise are unpaid through the nine months ended September 30, 2005.
     In addition, we have (i) an aggregate of $4.35 million in notes (plus accrued interest) from Toucan Capital maturing January 17, 2006 and $2.4 million (plus accrued interest) maturing thereafter and $400,000 maturing thereafter from Toucan Partners, L.L.C., (ii) $235,000 (plus accrued interest) from members of management maturing January 31, 2006, (iii) a net assessed tax liability to the State of Washington of approximately $329,000 with payment of the assessment expected to be due by December 31, 2005, (iv) capital lease obligations of approximately $20,500 as of September 30, 2005, (v) approximately $92,000 of earned and accrued but unpaid vacation and sick pay due employees through the nine months ended September 30, 2005, and (vi) an estimated liability due Toucan Capital, a related party, as disclosed on our balance sheet, of approximately $481,000 for their incurred cost, through the nine months ended September 30, 2005, in expenses that it has incurred, and which we have agreed to reimburse it, in connection with our recapitalization plan, including the financing it has provided to us.
     Low liquidity has made it necessary to slow payment of vendor invoices as revealed by our trade payables for the nine months ended September 30, 2005, aged as follows:

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Aged Trade Payables   (in thousands)  
 
Current:
  $ 271  
15 Days
    335  
30 Days
    75  
45 Days
    321  
60 Days
    2,299  
 
 
       
Total
    3,301  
     Through the nine months ended September 30, 2005, no vendors have requested a cash prepayment prior to delivering materials although they may require this condition at anytime. Regardless of whether an immediate demand for payment of any of these obligations is made, we will have to seek additional funds from Toucan Capital, which Toucan Capital is not obligated to provide us.
Toucan Capital has indicated it does not intend to provide further capital to us. We may be unable to obtain capital from new sources.
     Toucan Capital indicated in its Schedule 13D/A filed with the Securities and Exchange Commission on September 13, 2005, that it does not presently intend to provide further funding to us. There can be no assurance that we will be able to raise additional funds from any designee or affiliate of Toucan Capital or from any other source.
Our auditors have issued a “going concern” audit opinion.
     Our independent auditors have indicated in their report on our December 31, 2004 financial statements that there is substantial doubt about our ability to continue as a going concern. A “going concern” opinion indicates that the financial statements have been prepared assuming we will continue as a going concern and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty. Therefore, you should not rely on our consolidated balance sheet as an indication of the amount of proceeds that would be available to satisfy claims of creditors, and potentially be available for distribution to stockholders, in the event of a liquidation.
We expect to continue to incur substantial losses, and we may never achieve profitability.
     We have incurred net losses every year since our incorporation in July 1998 and, as of September 30, 2005, we had a deficit accumulated during the development stage of approximately $80.7 million. We have had net losses applicable to common stockholders as follows:
    $5.8 million in 2003;
 
    $8.6 million in 2004; and
 
    $7.9 million for the nine months ended September 30, 2005.

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     We expect that if we are able to continue operations these losses will continue and anticipate negative cash flows from operations for the foreseeable future. We may never achieve or sustain profitability.
As a company in the early stage of development with an unproven business strategy, our limited history of operations makes an evaluation of our business and prospects difficult.
     We have had a limited operating history and are still in development. We may not be able to achieve revenue growth in the future. We have generated the following limited revenues:
    $529,000 in 2003;
 
    $390,000 in 2004; and
 
    $110,000 for the nine months ended September 30, 2005.
     We have derived most of these limited revenues from:
    the sale of research products to a single customer;
 
    contract research and development from related parties; and
 
    research grants, and license fees.
     In the future, we anticipate that revenues, if any, will be derived through grants, partnering agreements, and, ultimately, the commercialization of our product candidates.
We have reduced business umbrella, auto, crime and fiduciary, and directors and officers liability insurance coverage.
     Due to rising insurance premiums for most business insurance coverage, our reduced level of operating activity, and reduced liability exposure through the cessation of all clinical trials, we lowered the levels of all of our insurance coverage. Making a material reduction in our insurance coverage may make it difficult for us to acquire new directors and officers, and will also result in increased exposure to potential liabilities arising from any future litigation, either of which may materially harm our business and results of operations.
We may not be able to retain or recruit personnel.
     Since September 2002, we reduced our research and administrative staff approximately 92.5%, from 67 employees to a remaining staff of five employees, as of September 30, 2005. The uncertainty of our cash position, workforce reductions, the volatility in our stock price and our recent asset sales may create anxiety and uncertainty, which may adversely affect employee morale and cause us to lose employees whom we would prefer to retain or prevent us from hiring qualified staff. To the extent that we are unable to retain our existing personnel, our business and financial results may suffer.
Failure to obtain regulatory approval for one or more of our product candidates could significantly harm our business.
     All of our product candidates are still under development. None of our product candidates will be commercially available prior to FDA approval. Significant further financial resources and personnel will be required to develop commercially viable products and obtain regulatory approvals. Much of our efforts and expenditures over the next few years will be devoted to completing the DCVax-Prostate and DCVax-Brain clinical trials and seeking FDA approval for these lead product candidates.
     Success in pre-clinical studies and prior clinical trials does not ensure that subsequent large-scale trials will likewise be successful, nor is it a basis for predicting final results. A number of companies in the biotechnology industry have suffered significant setbacks in advanced clinical trials, even after promising results have been achieved in earlier trials. Failure to obtain Food and Drug Administration, or FDA, approval for one or more of our product candidates could significantly harm our business.

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     We have neither manufacturing facilities nor expertise to produce our product candidates. We have never manufactured, on a commercial scale, any of our product candidates. We currently have manufacturing arrangements in place with a contract manufacturer (Cognate Therapeutics, Inc.). However, we may not be able to enter into agreements with contract manufactures for the manufacture of any of our product candidates at a reasonable cost or in sufficient quantities to be profitable.
Because we lack sales and marketing experience, we may experience significant difficulties commercializing our research product candidates.
     The commercial success of any of our product candidates will depend upon the strength of our sales and marketing efforts. We do not have a sales force and have no experience in the sales, marketing or distribution of products. To fully commercialize our product candidates, we will need to create a substantial marketing staff and sales force with technical expertise and the ability to distribute these products. As an alternative, we could seek assistance from a third party with a large distribution system and a large direct sales force. We may be unable to put either of these plans in place. In addition, if we arrange for others to market and sell our products, our revenues will depend upon the efforts of those parties. Such arrangements may not succeed. If we fail to establish adequate sales, marketing and distribution capabilities, independently or with others, our business will be seriously harmed.
Our success partially depends on existing and future partners.
     The success of our business strategy may partially depend upon our ability to develop and maintain multiple partnerships and to manage them effectively. The success of our restructured operations will depend on our ability to attract partners to our research initiatives. Due to concerns regarding our ability to continue operations, these third parties may decide not to conduct business with us, or may conduct business with us on terms that are less favorable than those customarily extended by them. If either of these events occurs, our business will suffer significantly.
     Our success depends partially upon the performance of our partners. We cannot directly control the amount and timing of resources that our existing or future partners devote to the research, development or marketing of our product candidates. As a result, those partners:
    may not commit sufficient resources to our programs or product candidates;
 
    may not conduct their agreed activities on time, or at all, resulting in delay or termination of the development of our product candidates and technology;
 
    may not perform their obligations as expected;
 
    may pursue products or alternative technologies in preference to ours; or
 
    may dispute the ownership of products or technology developed under our partnerships.
     We may have disputes with our partners, which could be costly and time consuming. Our failure to successfully defend our rights could seriously harm our business, financial condition and operating results. We intend to continue to enter into partnerships in the future. However, we may be unable to successfully negotiate any additional partnerships and any of these relationships, if established, may not be scientifically or commercially successful. We also work with scientists and medical professionals at academic and other institutions, including the University of California, Los Angeles, M.D. Anderson Cancer Center, and the H. Lee Moffitt Cancer Center some of whom have conducted research for us or assist us in developing our research and development strategy. These scientists and medical professionals are not our employees. They may have commitments to, or contracts with, other businesses or institutions that limit the amount of time they have available to work with us. We have little control over these individuals. We can only expect them to devote to our projects the amount of time required by our license, consulting and sponsored research agreements. In addition, these individuals may have arrangements with other companies to assist in developing technologies that may compete with ours. If these individuals do not devote sufficient time and resources to our programs, our business could be seriously harmed.

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Competition in our industry is intense and most of our competitors have substantially greater resources than we have.
     The biotechnology and biopharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products. Several companies, such as Cell Genesys, Inc., Dendreon Corporation and Immuno-Designed Molecules, Inc., are actively involved in the research and development of cell-based cancer therapeutics. Additionally, several companies, such as Abgenix, Inc., Agensys, Inc., and Genentech, Inc., are actively involved in the research and development of monoclonal antibody-based cancer therapies. Currently, at least seven antibody-based products are approved for commercial sale for cancer therapy. Genentech is also engaged in several Phase III clinical trials for additional antibody-based therapeutics for a variety of cancers, and several other companies are in early stage clinical trials for such products. Many other third parties compete with us in developing alternative therapies to treat cancer, including:
    biopharmaceutical companies;
 
    biotechnology companies;
 
    pharmaceutical companies;
 
    academic institutions; and
 
    other research organizations.
     Many of our competitors have significantly greater financial resources and expertise in research and development, manufacturing, pre-clinical testing, conducting clinical trials, obtaining regulatory approvals and marketing than we do. In addition, many of these competitors have become active in seeking patent protection and licensing arrangements in anticipation of collecting royalties for use of technology they have developed. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These third parties compete with us in recruiting and retaining qualified scientific and management personnel, as well as in acquiring technologies complementary to our programs.
     We expect that our ability to compete effectively will be dependent upon our ability to:
    obtain additional funding;
 
    successfully complete clinical trials and obtain all requisite regulatory approvals;
 
    maintain a proprietary position in our technologies and products;
 
    attract and retain key personnel; and
 
    maintain existing or enter into new partnerships.
     Our competitors may develop more effective or affordable products, or achieve earlier patent protection or product marketing and sales than we may. As a result, any products we develop may be rendered obsolete and noncompetitive.
Our intellectual property rights may not provide meaningful commercial protection for our research products or product candidates, which could enable third parties to use our technology, or very similar technology, and could reduce our ability to compete in the market.
     We rely on patent, copyright, trade secret and trademark laws to limit the ability of others to compete with us using the same or similar technology in the United States and other countries. However, as described below, these laws afford only limited protection and may not adequately protect our rights to the extent necessary to sustain any competitive advantage we may have. The laws of some foreign countries do not protect proprietary rights to the same extent as the laws of the United States, and we may encounter significant problems in protecting our proprietary rights in these countries.

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     We have 15 issued and licensed patents (eight in the United States and seven in foreign jurisdictions) and 104 patent applications pending (18 in the United States and 86 in foreign jurisdictions) which cover the use of dendritic cells in DCVax as well as targets for either our dendritic cell or fully human monoclonal antibody therapy candidates. The issued patents expire at dates from 2015 to 2018.
     We will only be able to protect our technologies from unauthorized use by third parties to the extent that they are covered by valid and enforceable patents or are effectively maintained as trade secrets. The patent positions of companies developing novel cancer treatments, including our patent position, generally are uncertain and involve complex legal and factual questions, particularly concerning the scope and enforceability of claims of such patents against alleged infringement. Recent judicial decisions are prompting a reinterpretation of the limited case law that exists in this area, and historical legal standards surrounding questions of infringement and validity may not apply in future cases. A reinterpretation of existing law in this area may limit or potentially eliminate our patent position and, therefore, our ability to prevent others from using our technologies. The biotechnology patent situation outside the United States is even more uncertain. Changes in either the patent laws or in interpretations of patent laws in the United States and other countries may therefore diminish the value of our intellectual property.
     We own or have rights under licenses to a variety of issued patents and pending patent applications. However, the patents on which we rely may be challenged and invalidated, and our patent applications may not result in issued patents. Moreover, our patents and patent applications may not be sufficiently broad to prevent others from practicing our technologies or from developing competing products. We also face the risk that others may independently develop similar or alternative technologies or design around our patented technologies.
     We have taken security measures to protect our proprietary information. These measures, however, may not provide adequate protection of our trade secrets or other proprietary information. We seek to protect our proprietary information by entering into confidentiality agreements with employees, partners and consultants. Nevertheless, employees, partners or consultants may still disclose our proprietary information, and we may not be able to protect our trade secrets in a meaningful way. If we lose any employees, we may not be able to prevent the unauthorized disclosure or use of our technical knowledge or other trade secrets by those former employees despite the existence of nondisclosure and confidentiality agreements and other contractual restrictions to protect our proprietary technology. In addition, others may independently develop substantially equivalent proprietary information or techniques or otherwise gain access to our trade secrets.
Our success will depend partly on our ability to operate without infringing or misappropriating the proprietary rights of others.
     Our success will depend to a substantial degree upon our ability to develop, manufacture, market and sell our research products and product candidates without infringing the proprietary rights of third parties and without breaching any licenses we have entered into regarding our product candidates.
     There is a substantial amount of litigation involving patent and other intellectual property rights in the biotechnology and biopharmaceutical industries generally. Infringement and other intellectual property claims, with or without merit, can be expensive and time-consuming to litigate and can divert management’s attention from our core business. We may be exposed to future litigation by third parties based on claims that our products infringe their intellectual property rights. This risk is exacerbated by the fact that there are numerous issued and pending patents in the biotechnology industry and the fact that the validity and breadth of biotechnology patents involve complex legal and factual questions for which important legal principles remain unresolved.

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     Third parties may assert that our products and the methods we employ are covered by U.S. or foreign patents held by them. In addition, because patent applications can take many years to issue, there may be currently pending applications, unknown to us, which may later result in issued patents that we may infringe. There could also be existing patents of which we are not aware that we may inadvertently infringe.
     If we lose a patent infringement lawsuit, we could be prevented from commercializing product candidates unless we can obtain a license to use technology or ideas covered by such patent or are able to redesign our products to
     avoid infringement. A license may not be available at all or on terms acceptable to us, or we may not be able to redesign our products to avoid any infringement. If we are not successful in obtaining a license or redesigning our products, we may be unable to commercializing our product candidates and our business could suffer.
We use hazardous materials and must comply with environmental, health and safety laws and regulations, which can be expensive and restrict how we do business.
     We store, handle, use and dispose of controlled hazardous, radioactive and biological materials in our business. Our current use of these materials generally is below thresholds giving rise to burdensome regulatory requirements. Our development efforts, however, may result in our becoming subject to additional requirements, and if we fail to comply with applicable requirements we could be subject to substantial fines and other sanctions, delays in research and production, and increased operating costs. In addition, if regulated materials were improperly released at our current or former facilities or at locations to which we send materials for disposal, we could be strictly liable for substantial damages and costs, including cleanup costs and personal injury or property damages, and incur delays in research and production and increased operating costs.
     Insurance covering certain types of claims of environmental damage or injury resulting from the use of these materials is available but can be expensive and is limited in its coverage. We have no insurance specifically covering environmental risks or personal injury from the use of these materials and if such use results in liability, our business may be seriously harmed.
Toucan Capital and affiliates own the vast majority of our stock and, as a result, the trading price for our shares may be depressed as they can take actions that may be adverse to your interests.
     From February 2, 2004 through November 14, 2005, we borrowed an aggregate of $7.15 million from Toucan Capital and Toucan Partners, L.L.C. and they have the right, as of November 14, 2005, to convert principal and interest on the loans to acquire up to approximately 195.2 million shares of our capital stock and have the right to acquire up to approximately 139.5 million shares upon exercise of related warrants, inclusive of the 13.0 million series A warrants granted to Toucan Capital. Including the 32.5 million shares of series A preferred stock held by Toucan Capital, these two entities in the aggregate have beneficial ownership of approximately 367.2 million shares of our capital stock, representing an as-converted beneficial ownership of approximately 93.6% of our common stock. Toucan Capital has a right of first refusal to participate in our future issuances of debt or equity securities.
     The notes held by Toucan Capital and Toucan Partners, L.L.C. are currently convertible into common stock or series A preferred stock at their election, at the price of $0.04 per share and the series A stock is similarly convertible into common stock. Finally, the warrants held by Toucan Capital and Toucan Partners, L.L.C. are exercisable at exercise prices ranging from $0.01 to $0.04 per share. This significant concentration of ownership may adversely affect the trading price for our common stock because investors often perceive disadvantages in owning stock in companies with controlling stockholders. Our management and Toucan Capital and affiliates, have the ability to exert substantial influence over all matters requiring approval by our stockholders, including the election and removal of directors and any proposed merger, consolidation or sale of all or substantially all of our assets. In addition, they can dictate the management of our business and affairs, including all future funding arrangements. This concentration of ownership could have the effect of delaying, deferring or preventing a change in control, or impeding a merger or consolidation, takeover or other business combination that could be favorable to you.

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     In addition, under the terms of our recapitalization agreement, we are required to consult with Toucan Capital on how we conduct many aspects of our business. As a result, Toucan Capital has significant authority over how we conduct our business, and with its stock acquisition rights, could influence or control all matters requiring stockholder approval. This control may cause us to conduct our business differently from the way we have in the past. The concentration of ownership may also delay, deter or prevent acts that would result in a change in control, which, in turn, could reduce the market price of our common stock.
There may not be an active, liquid trading market for our common stock.
     On December 14, 2001, our common stock was listed on the NASDAQ National Market. Prior to that time there was no public market for our common stock. On December 23, 2002, we were delisted from the NASDAQ National Market and our common stock is currently listed on the Over The Counter Bulletin Board (OTCBB), which is generally recognized as being a less active market than the NASDAQ National Market. You may not be able to sell your shares at the time or at the price desired.
Our common stock may experience extreme price and volume fluctuations, which could lead to costly litigation for us and make an investment in us less appealing.
     The market price of our common stock may fluctuate substantially due to a variety of factors, including:
    announcements of technological innovations or new products by us or our competitors;
 
    development and introduction of new cancer therapies;
 
    media reports and publications about cancer therapies;
 
    announcements concerning our competitors or the biotechnology industry in general;
 
    new regulatory pronouncements and changes in regulatory guidelines;
 
    general and industry-specific economic conditions;
 
    changes in financial estimates or recommendations by securities analysts; and
 
    changes in accounting principles.
     The market prices of the securities of biotechnology companies, particularly companies like ours without earnings and consistent product revenues, have been highly volatile and are likely to remain highly volatile in the future. This volatility has often been unrelated to the operating performance of particular companies. In the past, securities class action litigation has often been brought against companies that experience volatility in the market price of their securities. Moreover, market prices for stocks of biotechnology-related and technology companies occasionally trade at levels that bear no relationship to the operating performance of such companies. These market prices generally are not sustainable and are subject to wide variations. Whether or not meritorious, litigation brought against us could result in substantial costs, divert management’s attention and resources and harm our financial condition and results of operations.
Our incorporation documents, bylaws and stockholder rights plan may delay or prevent a change in our management.
     Our amended and restated certificate of incorporation, bylaws and stockholder rights plan contain provisions that could delay or prevent a change in our management team. Some of these provisions:
    authorize the issuance of preferred stock that can be created and issued by the board of directors without prior stockholder approval, commonly referred to as “blank check” preferred stock, with rights senior to those of common stock;

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    authorize our board of directors to issue dilutive shares of common stock upon certain events; and
 
    provide for a classified board of directors.
These provisions could allow our board of directors to affect your rights as a stockholder since our board of directors can make it more difficult for common stockholders to replace members of the board. Because our board of directors is responsible for appointing the members of our management team, these provisions could in turn affect any attempt to replace our current management team.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
     Our exposure to market risk is presently limited to the interest rate sensitivity of our cash and cash equivalents which is affected by changes in the general level of U.S. interest rates. We are exposed to interest rate changes primarily as a result of our investment activities. The primary objective of our investment activities is to preserve principal while at the same time maximizing the income we receive without significantly increasing risk. To minimize risk, we maintain our cash and cash equivalents in interest-bearing instruments, primarily money market funds. Our interest rate risk management objective with respect to our borrowings is to limit the impact of interest rate changes on earnings and cash flows. Due to the nature of our cash and cash equivalents, we believe that we are not subject to any material market risk exposure. We do not have any foreign currency or other derivative financial instruments.
Item 4. Controls and Procedures
     (a) Evaluation of disclosure controls and procedures.
     Our president and our controller, after evaluating, as required, the effectiveness of our “disclosure controls and procedures” (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)), recognized, as of September 30, 2005, our disclosure controls and procedures contained certain internal control weaknesses that, in the aggregate, represent material weaknesses. Accordingly, our president and controller determined that, as of September 30, 2005, our disclosure controls and procedures were not effective.
     The identified weaknesses were anticipated given our status with respect to our limited number of employees (five full-time employees). The weaknesses were comprised of (i) insufficient segregation of duties, (ii) insufficient corporate governance policies, and (iii) lack of independent directors as of September 30, 2005. Each of these weaknesses is expected to be corrected in the event that we are able to raise adequate funding to pursue our strategic business plan. SEC release No. 33-8545 extends the deadline for Sarbanes-Oxley Section 404 compliance for non-accelerated filers, such as our company, to the first fiscal year ending on or after July 15, 2006.
     As part of the communications by Peterson Sullivan with our audit committee with respect to Peterson Sullivan’s audit procedures for 2005, Peterson Sullivan informed the audit committee that these deficiencies constituted material weaknesses, as defined by Auditing Standard No. 2, “An Audit of Internal Control Over Financial Reporting Performed in Conjunction with an Audit of Financial Statements,” established by the Public Company Accounting Oversight Board, or PCAOB.
     (b) Changes in internal control over financial reporting.
     There were no significant changes in our internal control over financial reporting during the third quarter of 2005 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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Part II — Other Information
Item 1. Legal Proceedings
     On August 29, 2005, Soma Partners, LLC filed a notice of petition to vacate the arbitration award with the supreme court of the state of New York requesting that the May 24, 2005 findings of the arbitrator in favor of the Company be vacated. Legal proceedings are inherently unpredictable and the eventual outcome in a particular situation is impossible to determine in advance. We believe that Soma’s petition lacks merit and intend to vigorously pursue our various defences. A more detailed description of the original matter is set forth on page 25 of our Form 10-Q for the quarter ended June 30, 2005, filed with the Securities and Exchange Commission on August 15, 2005.
     If Soma were to prevail in their petition, and if Soma were to subsequently prevail in a second arbitration proceeding, we might at a minimum be potentially (i) liable for approximately $366,000 in placement fees, and (ii) required to grant a warrant to Soma for the purchase of approximately 2.0 million shares of our stock. Any such adverse result could have a adverse effect on our financial position and cash flow.
     We have no other legal proceeding pending at this time.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
     The information contained in Item 5 hereof is incorporated by reference herein.
Item 3. Defaults upon Senior Securities
     None
Item 4. Submission of Matters to a Vote of Security Holders
     No matters were submitted to a vote of our stockholders during the three months ended September 30, 2005.
Item 5. Other Information
     On November 14, 2005 we received a $400,000 loan from Toucan Partners, L.L.C, or Toucan Partners, an affiliate of Toucan Capital Fund II, L.P. This loan accrues interest at 10% per year, matures on November 14, 2006, and the principal and interest is convertible into shares of our capital stock, generally at Toucan Partners’ 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, we issued a warrant to Toucan Partners, which is exercisable for up to 4.0 million shares of our capital stock. The exercise price of the warrant is $0.04 per share subject to certain adjustments. We believe that the $400,000 received from Toucan Partners on November 14, 2005 should cover general operating expenses and certain other expenses of ours through approximately December 7, 2005.
     From February 2, 2004 through November 14, 2005, we have undergone a significant recapitalization pursuant to which Toucan Capital and its affiliate Toucan Partners, have loaned us an aggregate of $7.15 million. On January 26, 2005, we entered into a securities purchase agreement with Toucan Capital pursuant to which they purchased 32.5 million shares of the Company’s newly designated series A preferred stock at a purchase price of $0.04 per share, for a net purchase price of $1.276 million, net of issue related costs of approximately $24,000.
     In connection with the recent loan from Toucan Partners, we amended the Amended and Restated Recapitalization Agreement with Toucan Capital (the “Recapitalization Agreement”), dated as of July 30, 2004, and amended on October 22, 2004, November 10, 2004, December 27, 2004, January 26, 2005, April 12, 2005, May 13, 2005, June 16, 2005, July 26, 2005, September 7, 2005, and November 14, 2005. The November 14, 2005 amendment (i) updated certain representations and warranties of the parties made in the Recapitalization Agreement, and (ii) made certain technical changes in the Recapitalization Agreement in order to facilitate the November 14, 2005 loan including the designation of Toucan Partners as Toucan Capital’s designee for purposes of participating in the transaction.
     Also in connection with our loan from Toucan Partners, Toucan Capital and we amended the Amended and Restated Binding Term Sheet dated April 26, 2004, and amended and restated on July 30, 2004, October 22, 2004, November 10, 2004 and further amended on December 27, 2004, January 26, 2005, April 12, 2005, May 13, 2005, June 16, 2005, July 26, 2005, September 7, 2005, and November 14, 2005 between the parties (the “Term Sheet”). The amendment to the Term Sheet reduced warrant coverage in the potential private placement by $400,000.
     The Recapitalization Agreement calls for a two-stage recapitalization consisting of a bridge period and an equity financing period. The equity financing period commenced on January 26, 2005 when Toucan Capital purchased 32,500,000 shares of our series A cumulative convertible preferred stock at a purchase price of $0.04 per share (for an aggregate purchase price of $1,300,000). The equity financing period will end on December 31, 2006 (or such later date as is mutually agreed by the parties). During the equity financing period, we intend to sell up to $40 million of convertible preferred stock in accordance with the terms of the Recapitalization Agreement. Any additional financing is contingent upon us complying with covenants in the Recapitalization Agreement, as amended, and locating additional investors who are willing to invest on the terms proposed.
     In addition, on November 14, 2005 we and Toucan Capital amended the eight Loan Agreements, Security Agreements and 10% Convertible, Secured Promissory Notes, representing an aggregate principal of $4.35 million, and originally issued on February 2, 2004, March 1, 2004, April 26, 2004, June 11, 2004, July 30, 2004, October 22, 2004, November 10, 2004 and December 27, 2004 to change the respective maturity dates of each such note to January 17, 2006.
     On November 14, 2005, we and certain members of management who hold notes, representing an aggregate principal of $235,000 as set forth in the following table, originally dated November 13, 2003, as amended on April 26, 2004, April 12, 2005, June 16, 2005, and July 26, 2005, amended these notes to extend the maturity date of each respective remaining note to January 31, 2006.
                 
Lender   Title   Principal (1)  
Alton L. Boynton, Ph.D.
  Director, President, Chief Scientific Officer, Chief Operating Officer and Secretary   $ 183,000  
Marnix Bosch, Ph.D.
  Vice President of Vaccine Research and Development     41,000  
Larry L. Richards
  Controller (Principal Financial and Accounting Officer)     11,000  
 
  Total   $ 235,000  
     (1) Date of original notes November 13, 2003.
     The foregoing description of the Amendment to the Recapitalization Agreement, the note, the warrant, the amendment to the Term Sheet, the management note amendments, and the amendments to the convertible secured promissory notes, all of which are filed as exhibits to this Form 10-Q, are qualified in their entirety by reference to the full text of the agreements.

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Item 6. Exhibits
     a) Exhibits
     
3.1
  Sixth Amended and Restated Certificate of Incorporation. (3.1) (1)
 
   
3.2
  Certificate of Designations, Preferences and Rights of Series A Cumulative Convertible Preferred Stock. (3.1) (2)
 
   
3.3
  Second Amended and Restated Bylaws of Northwest Biotherapeutics, Inc. (3.2) (2)
 
   
10.1
  Amendment No. 8 to the Amended and Restated Recapitalization Agreement between Northwest Biotherapeutics, Inc. and Toucan Capital Fund II, L.P., dated July 26, 2005. (10.1) (1)
 
   
10.2
  Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note in the principal amount of $500,000 between Northwest Biotherapeutics, Inc. and Toucan Capital Fund II, L.P., dated July 26, 2005. (10.2) (1)
 
   
10.3
  Warrant to purchase securities of the Company dated July 26, 2005 issued to Toucan Capital Fund II, L.P. (10.3) (1)
 
   
10.4
  Sixth Amendment to Amended and Restated Binding Term Sheet, dated July 26, 2005. (10.4) (1)
 
   
10.5
  Second Amendment To Amended And Restated Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note dated February 2, 2004 in the principal amount of $50,000 between the Company and Toucan Capital Fund II, L.P., dated July 26, 2005. (10.5) (1)
 
   
10.6
  Second Amendment To Amended And Restated Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note dated March 1, 2004 in the principal amount of $50,000 between the Company and Toucan Capital Fund II, L.P., dated July 26, 2005. (10.6) (1)
 
   
10.7
  Second Amendment To Amended And Restated Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note dated April 26, 2004 in the principal amount of $500,000 between the Company and Toucan Capital Fund II, L.P., dated July 26, 2005. (10.7) (1)
 
   
10.8
  First Amendment To Amended And Restated Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note dated June 11, 2004 in the principal amount of $500,000 between the Company and Toucan Capital Fund II, L.P., dated July 26, 2005. (10.8) (1)
 
   
10.9
  First Amendment To Amended And Restated Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note dated July 30, 2004 in the principal amount of $2,000,000 between the Company and Toucan Capital Fund II, L.P., dated July 26, 2005. (10.9) (1)
 
   
10.10
  First Amendment To Amended And Restated Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note dated October 22, 2004 in the principal amount of $500,000 between the Company and Toucan Capital Fund II, L.P., dated July 26, 2005. (10.10) (1)
 
   
10.11
  Form of Fourth Amendment To Convertible Secured Promissory Note between the Company and Holders of the November 13, 2003 Convertible Secured Promissory Note, dated July 26, 2005. (10.11) (1)
 
   
10.12
  Amendment No. 9 to the Amended and Restated Recapitalization Agreement between Northwest Biotherapeutics, Inc. and Toucan Capital Fund II, L.P., dated September 7, 2005. (10.1) (3)
 
   
10.13
  Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note in the principal amount of $500,000 between Northwest Biotherapeutics, Inc. and Toucan Capital Fund II, L.P., dated September 7, 2005. (10.2) (3)
 
   
10.14
  Warrant to purchase securities of the Company dated September 7, 2005 issued to Toucan Capital Fund II, L.P. (10.3) (3)
 
   
10.15
  Seventh Amendment to Amended and Restated Binding Term Sheet, dated September 7, 2005. (10.4) (3)
 
   
10.16
  Employment Agreement between Northwest Biotherapeutics, Inc., and Paul Zeltzer, dated August 1, 2005. (99.1) (2)
 
   
10.17
  Third Amendment To Amended And Restated Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note dated February 2, 2004 in the principal amount of $50,000 between the Company and Toucan Capital Fund II, L.P., dated November 14, 2005.*
 
   
10.18
  Third Amendment To Amended And Restated Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note dated March 1, 2004 in the principal amount of $50,000 between the Company and Toucan Capital Fund II, L.P., dated November 14, 2005.*

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10.19
  Third Amendment To Amended And Restated Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note dated April 26, 2004 in the principal amount of $500,000 between the Company and Toucan Capital Fund II, L.P., dated November 14, 2005.*
 
   
10.20
  Second Amendment To Amended And Restated Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note dated June 11, 2004 in the principal amount of $500,000 between the Company and Toucan Capital Fund II, L.P., dated November 14, 2005.*
 
   
10.21
  Second Amendment To Amended And Restated Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note dated July 30, 2004 in the principal amount of $2,000,000 between the Company and Toucan Capital Fund II, L.P., dated November 14, 2005.*
 
   
10.22
  Second Amendment To Amended And Restated Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note dated October 22, 2004 in the principal amount of $500,000 between the Company and Toucan Capital Fund II, L.P., dated November 14, 2005.*
 
   
10.23
  First Amendment To Amended And Restated Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note dated November 10, 2004 in the principal amount of $500,000 between the Company and Toucan Capital Fund II, L.P., dated November 14, 2005.*
 
   
10.24
  First Amendment To Amended And Restated Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note dated December 27, 2004 in the principal amount of $250,000 between the Company and Toucan Capital Fund II, L.P., dated November 14, 2005.*
 
   
10.25
  Form of Fifth Amendment To Convertible Secured Promissory Note between the Company and Holders of the November 13, 2003 Convertible Secured Promissory Notes, dated November 14, 2005.*
 
   
10.26
  Amendment No. 10 to the Amended and Restated Recapitalization Agreement between Northwest Biotherapeutics, Inc., Toucan Capital Fund II, L.P., and Toucan Partners, L.L.C., dated November 14, 2005.*
 
   
10.27
  Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note in the principal amount of $400,000 between Northwest Biotherapeutics, Inc., and Toucan Partners, L.L.C., dated November 14, 2005.*
 
   
10.28
  Warrant to purchase securities of the Company dated November 14, 2005 issued to Toucan Partners, L.L.C.*
 
   
10.29
  Eighth Amendment to Amended and Restated Binding Term Sheet, dated November 14, 2005.*
 
   
31.1
  Certification of President (Principal Executive Officer), Pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a), as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.*
 
   
31.2
  Certification of Controller (Principal Financial and Accounting Officer), Pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a), as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.*
 
   
32.1
  Certification of President Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.*
 
   
32.2
  Certification of Controller Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.*
 
*   Filed herewith.
(1)   Incorporated by reference to the exhibit shown in the preceding parentheses filed with the Registrant’s Form 8-K on August 1, 2005.
 
(2)   Incorporated by reference to the exhibit shown in the preceding parentheses filed with the Registrant’s Form 8-K on August 5, 2005.
 
(3)   Incorporated by reference to the exhibit shown in the preceding parentheses filed with the Registrant’s Form 8-K on September 9, 2005.

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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
 
 
Dated: November 14, 2005  By:   /s/ Alton L. Boynton    
    Alton L. Boynton   
    President (Principal Executive Officer)   
 
         
     
Dated: November 14, 2005  By:   /s/ Larry L. Richards    
    Larry L. Richards   
    Controller (Principal Financial and Accounting Officer)   
 

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NORTHWEST BIOTHERAPEUTICS, INC.
(A Development Stage Company)
EXHIBIT INDEX
     
Exhibit    
Number   Description
3.1
  Sixth Amended and Restated Certificate of Incorporation. (3.1) (1)
 
   
3.2
  Certificate of Designations, Preferences and Rights of Series A Cumulative Convertible Preferred Stock. (3.1) (2)
 
   
3.3
  Second Amended and Restated Bylaws of Northwest Biotherapeutics, Inc. (3.2) (2)
 
   
10.1
  Amendment No. 8 to the Amended and Restated Recapitalization Agreement between Northwest Biotherapeutics, Inc. and Toucan Capital Fund II, L.P., dated July 26, 2005. (10.1) (1)
 
   
10.2
  Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note in the principal amount of $500,000 between Northwest Biotherapeutics, Inc. and Toucan Capital Fund II, L.P., dated July 26, 2005. (10.2) (1)
 
   
10.3
  Warrant to purchase securities of the Company dated July 26, 2005 issued to Toucan Capital Fund II, L.P. (10.3) (1)
 
   
10.4
  Sixth Amendment to Amended and Restated Binding Term Sheet, dated July 26, 2005. (10.4) (1)
 
   
10.5
  Second Amendment To Amended And Restated Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note dated February 2, 2004 in the principal amount of $50,000 between the Company and Toucan Capital Fund II, L.P., dated July 26, 2005. (10.5) (1)
 
   
10.6
  Second Amendment To Amended And Restated Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note dated March 1, 2004 in the principal amount of $50,000 between the Company and Toucan Capital Fund II, L.P., dated July 26, 2005. (10.6) (1)
 
   
10.7
  Second Amendment To Amended And Restated Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note dated April 26, 2004 in the principal amount of $500,000 between the Company and Toucan Capital Fund II, L.P., dated July 26, 2005. (10.7) (1)
 
   
10.8
  First Amendment To Amended And Restated Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note dated June 11, 2004 in the principal amount of $500,000 between the Company and Toucan Capital Fund II, L.P., dated July 26, 2005. (10.8) (1)
 
   
10.9
  First Amendment To Amended And Restated Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note dated July 30, 2004 in the principal amount of $2,000,000 between the Company and Toucan Capital Fund II, L.P., dated July 26, 2005. (10.9) (1)
 
   
10.10
  First Amendment To Amended And Restated Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note dated October 22, 2004 in the principal amount of $500,000 between the Company and Toucan Capital Fund II, L.P., dated July 26, 2005. (10.10) (1)
 
   
10.11
  Form of Fourth Amendment To Convertible Secured Promissory Note between the Company and Holders of the November 13, 2003 Convertible Secured Promissory Note, dated July 26, 2005. (10.11) (1)
 
   
10.12
  Amendment No. 9 to the Amended and Restated Recapitalization Agreement between Northwest Biotherapeutics, Inc. and Toucan Capital Fund II, L.P., dated September 7, 2005. (10.1) (3)
 
   
10.13
  Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note in the principal amount of $500,000 between Northwest Biotherapeutics, Inc. and Toucan Capital Fund II, L.P., dated September 7, 2005. (10.2) (3)
 
   
10.14
  Warrant to purchase securities of the Company dated September 7, 2005 issued to Toucan Capital Fund II, L.P. (10.3) (3)
 
   
10.15
  Seventh Amendment to Amended and Restated Binding Term Sheet, dated September 7, 2005. (10.4) (3)
 
   
10.16
  Employment Agreement between Northwest Biotherapeutics, Inc., and Paul Zeltzer, dated August 1, 2005. (99.1) (2)
 
   
10.17
  Third Amendment To Amended And Restated Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note dated February 2, 2004 in the principal amount of $50,000 between the Company and Toucan Capital Fund II, L.P., dated November 14, 2005.*

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Exhibit    
Number   Description
 
   
10.18
  Third Amendment To Amended And Restated Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note dated March 1, 2004 in the principal amount of $50,000 between the Company and Toucan Capital Fund II, L.P., dated November 14, 2005.*
 
   
10.19
  Third Amendment To Amended And Restated Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note dated April 26, 2004 in the principal amount of $500,000 between the Company and Toucan Capital Fund II, L.P., dated November 14, 2005.*
 
   
10.20
  Second Amendment To Amended And Restated Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note dated June 11, 2004 in the principal amount of $500,000 between the Company and Toucan Capital Fund II, L.P., dated November 14, 2005.*
 
   
10.21
  Second Amendment To Amended And Restated Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note dated July 30, 2004 in the principal amount of $2,000,000 between the Company and Toucan Capital Fund II, L.P., dated November 14, 2005.*
 
   
10.22
  Second Amendment To Amended And Restated Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note dated October 22, 2004 in the principal amount of $500,000 between the Company and Toucan Capital Fund II, L.P., dated November 14, 2005.*
 
   
10.23
  First Amendment To Amended And Restated Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note dated November 10, 2004 in the principal amount of $500,000 between the Company and Toucan Capital Fund II, L.P., dated November 14, 2005.*
 
   
10.24
  First Amendment To Amended And Restated Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note dated December 27, 2004 in the principal amount of $250,000 between the Company and Toucan Capital Fund II, L.P., dated November 14, 2005.*
 
   
10.25
  Form of Fifth Amendment To Convertible Secured Promissory Note between the Company and Holders of the November 13, 2003 Convertible Secured Promissory Notes, dated November 14, 2005.*
 
   
10.26
  Amendment No. 10 to the Amended and Restated Recapitalization Agreement between Northwest Biotherapeutics, Inc., Toucan Capital Fund II, L.P., and Toucan Partners, L.L.C., dated November 14, 2005.*
 
   
10.27
  Loan Agreement, Security Agreement and 10% Convertible, Secured Promissory Note in the principal amount of $400,000 between Northwest Biotherapeutics, Inc. and Toucan Partners, L.L.C., dated November 14, 2005.*
 
   
10.28
  Warrant to purchase securities of the Company dated November 14, 2005 issued to Toucan Partners, L.L.C.*
 
   
10.29
  Eighth Amendment to Amended and Restated Binding Term Sheet, dated November 14, 2005.*
 
   
31.1
  Certification of President (Principal Executive Officer), Pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a), as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.*
 
   
31.2
  Certification of Controller (Principal Financial and Accounting Officer), Pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a), as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.*
 
   
32.1
  Certification of President Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.*
 
   
32.2
  Certification of Controller Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.*
 
*   Filed herewith.
 
(1)   Incorporated by reference to the exhibit shown in the preceding parentheses filed with the Registrant’s Form 8-K on August 1, 2005.
 
(2)   Incorporated by reference to the exhibit shown in the preceding parentheses filed with the Registrant’s Form 8-K on August 5, 2005.
 
(3)   Incorporated by reference to the exhibit shown in the preceding parentheses filed with the Registrant’s Form 8-K on September 9, 2005.

33