NORTHWEST BIOTHERAPEUTICS INC - Quarter Report: 2005 September (Form 10-Q)
Table of Contents
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)
(Address of Principal Executive Offices, Including Zip Code)
(425) 608-3000
(Registrants Telephone Number, Including Area Code)
(Registrants 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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Table of Contents
Part I Financial Information
Item 1. Financial Statements
NORTHWEST BIOTHERAPEUTICS, INC .
(A Development Stage Company)
(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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Table of Contents
NORTHWEST BIOTHERAPEUTICS, INC.
(A Development Stage Company)
(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)
(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)
(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 Companys Annual Report on Form 10-K for the year ended December 31, 2004, as filed with the
Securities and Exchange Commission.
The auditors 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 Companys 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
Companys 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 Companys independent auditors have indicated in their report on the Companys financial
statements, included in the Companys December 31, 2004 annual report on Form 10-K, that there is
substantial doubt about the Companys 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 Companys 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 Companys 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 Companys 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 Capitals 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 Companys outstanding capital stock. As part of the Companys
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 Companys 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 Companys 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 Capitals 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 Companys 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
Washingtons 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. Managements 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
Washingtons 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 grants 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 grants 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 managements 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 managements 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; |
26
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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 Sullivans 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.
27
Table of Contents
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 Somas 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 Companys 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 Capitals 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.
28
Table of Contents
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.* |
29
Table of Contents
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 Registrants Form 8-K on August 1, 2005. | |
(2) | Incorporated by reference to the exhibit shown in the preceding parentheses filed with the Registrants Form 8-K on August 5, 2005. | |
(3) | Incorporated by reference to the exhibit shown in the preceding parentheses filed with the Registrants Form 8-K on September 9, 2005. |
30
Table of Contents
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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Table of Contents
NORTHWEST BIOTHERAPEUTICS, INC.
(A Development Stage Company)
EXHIBIT INDEX
(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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Table of Contents
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 Registrants Form 8-K on August 1, 2005. | |
(2) | Incorporated by reference to the exhibit shown in the preceding parentheses filed with the Registrants Form 8-K on August 5, 2005. | |
(3) | Incorporated by reference to the exhibit shown in the preceding parentheses filed with the Registrants Form 8-K on September 9, 2005. |
33