NORTHWEST BIOTHERAPEUTICS INC - Quarter Report: 2007 March (Form 10-Q)
Table of Contents
UNITED STATES 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 March 31, 2007
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.
Incorporated under the laws of the State of Delaware |
I.R.S. Employer Identification No. 94-3306718 |
18701 120th Avenue NE, Suite 101
Bothell, Washington 98011
(425) 608-3000
Bothell, Washington 98011
(425) 608-3000
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 a large accelerated filer, an accelerated
filer, or a non-accelerated filer. See definition of accelerated filer and large accelerated
filer in Rule 12b-2 of the Exchange Act
Large accelerated filer o | Accelerated filer o | Non-accelerated filer 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 April 30, 2007, the total shares of common stock outstanding is 65,241,287.
TABLE OF CONTENTS
NORTHWEST BIOTHERAPEUTICS, INC.
TABLE OF CONTENTS
Page | ||||||||
3 | ||||||||
4 | ||||||||
5-6 | ||||||||
7-12 | ||||||||
13-16 | ||||||||
17 | ||||||||
17 | ||||||||
18 | ||||||||
19-26 | ||||||||
27 | ||||||||
27 | ||||||||
27 | ||||||||
27 | ||||||||
28 | ||||||||
29 | ||||||||
30 | ||||||||
Exhibit 31.1 | ||||||||
Exhibit 31.2 | ||||||||
Exhibit 32.1 | ||||||||
Exhibit 32.2 |
2
Table of Contents
Part I Financial Information
NORTHWEST BIOTHERAPEUTICS, INC.
(A Development Stage Company)
(A Development Stage Company)
Balance Sheets
(in thousands)
(Unaudited)
(in thousands)
(Unaudited)
December 31, | March 31, | |||||||
2006 | 2007 | |||||||
Assets |
||||||||
Current assets: |
||||||||
Cash |
$ | 307 | $ | 11 | ||||
Accounts receivable |
3 | | ||||||
Prepaid expenses and other current assets |
145 | 276 | ||||||
Total current assets |
455 | 287 | ||||||
Property and equipment: |
||||||||
Laboratory equipment |
14 | 25 | ||||||
Office furniture and other equipment |
71 | 86 | ||||||
85 | 111 | |||||||
Less accumulated depreciation and amortization |
(70 | ) | (95 | ) | ||||
Property and equipment, net |
15 | 16 | ||||||
Restricted cash |
31 | 31 | ||||||
Deposit and other non-current assets |
3 | 3 | ||||||
Total assets |
$ | 504 | $ | 337 | ||||
Liabilities And Stockholders Equity |
||||||||
Current Liabilities: |
||||||||
Note payable to related parties, net of discount |
$ | 2,505 | $ | 3,635 | ||||
Current portion of capital lease obligations |
2 | 1 | ||||||
Accounts payable |
493 | 805 | ||||||
Accounts payable, related party |
2,852 | 3,073 | ||||||
Accrued expenses |
301 | 420 | ||||||
Accrued expense, related party |
300 | 300 | ||||||
Total current liabilities |
6,453 | 8,234 | ||||||
Stockholders equity: |
||||||||
Preferred stock,
$0.001 par value; 300,000,000 shares authorized at December 31, 2006 and March 2007 |
||||||||
Series A Preferred stock, 50,000,000
designated and 32,500,000 shares issued and
outstanding at December 31, 2006 and March 31, 2007 |
33 | 33 | ||||||
Series A-1 Preferred stock, 10,000,000
designated and 4,816,863 shares issued and outstanding at December 31, 2006 and March 31, 2007 |
5 | 5 | ||||||
Common stock, $0.001 par value; 800,000,000 shares
authorized and 65,241,286 shares issued and outstanding
at December 31, 2006 and March 31, 2007 |
65 | 65 | ||||||
Additional paid-in capital |
78,033 | 78,037 | ||||||
Deficit accumulated during the development stage |
(84,085 | ) | (86,037 | ) | ||||
Total stockholders equity |
(5,949 | ) | (7,897 | ) | ||||
Total liabilities and stockholders equity |
$ | 504 | $ | 337 | ||||
See accompanying notes to condensed financial statements.
3
Table of Contents
NORTHWEST BIOTHERAPEUTICS, INC.
(A Development Stage Company)
(A Development Stage Company)
Statements of Operations
(in thousands, except per share data)
(Unaudited)
(in thousands, except per share data)
(Unaudited)
Period from | ||||||||||||
March 18, 1996 | ||||||||||||
Three Months Ended | (Inception) to | |||||||||||
March 31, | March 31, | |||||||||||
2006 | 2007 | 2007 | ||||||||||
Revenues: |
||||||||||||
Research material sales |
$ | | $ | | $ | 530 | ||||||
Contract research and development from related parties |
| | 1,128 | |||||||||
Research grants and other |
| | 1,061 | |||||||||
Total revenues |
| | 2,719 | |||||||||
Operating expenses: |
||||||||||||
Cost of research material sales |
| | 382 | |||||||||
Research and development |
427 | 1,311 | 37,155 | |||||||||
General and administrative |
443 | 501 | 33,468 | |||||||||
Depreciation and amortization |
10 | 10 | 2,313 | |||||||||
Loss on facility sublease and lease cancellation |
| | 895 | |||||||||
Asset impairment loss and (gain) loss on disposal of equipment |
(16 | ) | | 2,056 | ||||||||
Total operating expenses |
864 | 1,822 | 76,269 | |||||||||
Loss from operations |
(864 | ) | (1,822 | ) | (73,550 | ) | ||||||
Other income (expense): |
||||||||||||
Warrant valuation |
(2,113 | ) | | 6,759 | ||||||||
Gain on sale of intellectual property to Medarex |
| | 3,656 | |||||||||
Interest expense |
(982 | ) | (131 | ) | (15,832 | ) | ||||||
Interest income |
1 | 1 | 776 | |||||||||
Net loss |
(3,958 | ) | (1,952 | ) | (78,191 | ) | ||||||
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 |
$ | (3,958 | ) | $ | (1,952 | ) | $ | (86,037 | ) | |||
Net loss per share applicable to common stockholders basic and diluted |
$ | (0.21 | ) | $ | (0.03 | ) | ||||||
Weighted average shares used in computing basic and diluted loss per
share (in thousands) |
19,230 | 65,241 | ||||||||||
See accompanying notes to condensed financial statements.
4
Table of Contents
Northwest Biotherapeutics, Inc.
(A Development Stage Company)
(A Development Stage Company)
Condensed Statements of Cash Flows
(in thousands)
(Unaudited)
(in thousands)
(Unaudited)
Period from | ||||||||||||
Three Months Ended | March 18, 1996 | |||||||||||
March 31, | (Inception) to | |||||||||||
2006 | 2007 | March 31, 2007 | ||||||||||
Cash Flows from Operating Activities: |
||||||||||||
Net Loss |
$ | (3,958 | ) | $ | (1,952 | ) | $ | (78,191 | ) | |||
Reconciliation of net loss to net cash used in operating activities: |
||||||||||||
Depreciation and amortization |
10 | 10 | 2,313 | |||||||||
Amortization of deferred financing costs |
| | 320 | |||||||||
Amortization debt discount |
771 | 56 | 12,302 | |||||||||
Accrued interest converted to preferred stock |
| | 260 | |||||||||
Accreted interest on convertible promissory note |
201 | 74 | 1,195 | |||||||||
Stock-based compensation costs |
2 | 4 | 1,116 | |||||||||
Gain on sale of intellectual property and royalty rights |
| | (3,656 | ) | ||||||||
Loss (gain) on sale of property and equipment |
(16 | ) | | 273 | ||||||||
Warrant valuation |
2,113 | | (6,759 | ) | ||||||||
Asset impairment loss |
| | 2,066 | |||||||||
Loss on facility sublease |
| | 895 | |||||||||
Increase (decrease) in cash resulting from changes in assets and liabilities: |
||||||||||||
Accounts receivable |
17 | 3 | | |||||||||
Prepaid expenses and other current assets |
31 | (131 | ) | 190 | ||||||||
Accounts payable and accrued expenses |
220 | 653 | 4,996 | |||||||||
Accrued loss on sublease |
| | (265 | ) | ||||||||
Deferred rent |
| | 410 | |||||||||
Net Cash used in Operating Activities |
(609 | ) | (1,283 | ) | (62,535 | ) | ||||||
Cash Flows from Investing Activities: |
||||||||||||
Purchase of property and equipment, net |
| (11 | ) | (4,591 | ) | |||||||
Proceeds from sale of property and equipment |
16 | | 250 | |||||||||
Proceeds from sale of intellectual property |
| | 1,816 | |||||||||
Proceeds from sale of marketable securities |
| | 2,000 | |||||||||
Refund of security deposit |
| | (3 | ) | ||||||||
Transfer of restricted cash |
| | (1,035 | ) | ||||||||
Net Cash provided by (used in) Investing Activities |
16 | (11 | ) | (1,563 | ) | |||||||
Cash Flows from Financing Activities: |
||||||||||||
Proceeds from issuance of note payable to stockholder |
| 1,000 | 4,150 | |||||||||
Repayment of note payable to stockholder |
| | (1,650 | ) | ||||||||
Proceeds from issuance of convertible promissory note and warrants, net of
issuance costs |
300 | | 13,099 | |||||||||
Borrowing under line of credit, Northwest Hospital |
| | 2,834 | |||||||||
Repayment of line of credit, Northwest Hospital |
| | (2,834 | ) | ||||||||
Repayment of convertible promissory note |
(13 | ) | | (119 | ) | |||||||
Payment on capital lease obligations |
(5 | ) | (2 | ) | (323 | ) | ||||||
Payments on note payable |
| | (420 | ) | ||||||||
Proceeds from issuance Series A cumulative preferred stock, net |
| | 28,708 | |||||||||
Proceeds from exercise of stock options and warrants |
| | 227 | |||||||||
Proceeds from issuance common stock, net |
| | 22,457 | |||||||||
Advance on funding commitment for common stock |
2,900 | | | |||||||||
Mandatorily redeemable Series A preferred stock redemption fee |
| | (1,700 | ) | ||||||||
Deferred financing costs |
| | (320 | ) | ||||||||
Net Cash provided by Financing Activities |
3,182 | 998 | 64,109 | |||||||||
Net increase (decrease) in cash and cash equivalents |
2,589 | (296 | ) | 11 | ||||||||
Cash and cash equivalents at beginning of period |
352 | 307 | | |||||||||
Cash and cash equivalents at end of period |
$ | 2,941 | $ | 11 | $ | 11 | ||||||
5
Table of Contents
Period from | ||||||||||||
Three Months Ended | March 18, 1996 | |||||||||||
March 31, | (Inception) to | |||||||||||
2006 | 2007 | March 31, 2007 | ||||||||||
Supplemental disclosure of cash flow information |
||||||||||||
Cash paid during the period for interest |
$ | 12 | $ | 1 | $ | 1,396 | ||||||
Supplemental schedule of non-cash financing activities |
||||||||||||
Equipment acquired through capital leases |
| | 285 | |||||||||
Common stock warrant liability |
6,719 | | 11,841 | |||||||||
Accretion of mandatorily redeemable Series A preferred stock redemption
obligation |
| | 1,872 | |||||||||
Beneficial conversion feature of convertible promissory notes |
64 | | 7,242 | |||||||||
Conversion of convertible promissory notes and accrued interest to Series D
preferred stock |
| | 5,324 | |||||||||
Conversion of convertible promissory notes and accrued interest to
Series A-1
preferred stock |
| | 7,707 | |||||||||
Conversion of convertible promissory notes and accrued interest to common stock |
| | 269 | |||||||||
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 |
| | 759 | |||||||||
Cancellation of options and restricted stock |
| | 849 | |||||||||
Financing of prepaid insurance through note payable |
| | 491 | |||||||||
Stock subscription receivable |
| | 480 |
See accompanying notes to condensed financial statements.
6
Table of Contents
Northwest Biotherapeutics, Inc.
(A Development Stage Company)
(A Development Stage Company)
Notes to Condensed Financial Statements
(unaudited)
(unaudited)
1. | Basis of Presentation |
The accompanying condensed financial statements are unaudited and include the accounts of
Northwest Biotherapeutics, Inc. The accompanying unaudited condensed financial statements should be
read in conjunction with the financial statements included in our Annual Report on Form 10-K for
the year ended December 31, 2006. The year-end condensed balance sheet data was derived from
audited financial statements, but does not include all disclosures required by accounting
principles generally accepted in the United States of America. All normal recurring adjustments
which are necessary for the fair presentation of the results for the interim periods are reflected
herein. Operating results for the three-month period ended March 31, 2007 are not necessarily
indicative of results to be expected for a full year.
The auditors report on the financial statements for the fiscal year ended December 31, 2006
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.
2. | Summary of significant accounting policies |
The significant accounting policies used in the preparation of the Companys consolidated
financial statements are disclosed in the Annual Report on Form 10-K for the year ended December
31, 2006. Additional significant accounting policies are disclosed below.
Accounting for Income Taxes
In June 2006, the FASB issued FASB Interpretation No. 48 (FIN 48), Accounting for Uncertainty
in Income Taxesan interpretation of FASB Statement No. 109, Accounting for Income Taxes, which
clarifies the accounting for uncertainty in income taxes. FIN 48 prescribes a recognition threshold
and measurement attribute for the financial statement recognition and measurement of a tax position
taken or expected to be taken in a tax return. The interpretation requires that we recognize in the
financial statements, the impact of a tax position, if that position is more likely than not of
being sustained on audit, based on the technical merits of the position. FIN 48 also provides
guidance on derecognition, classification, interest and penalties, accounting in interim periods
and disclosure. The provisions of FIN 48 are effective beginning January 1, 2007 with the
cumulative effect of the change in accounting principle recorded as an adjustment to opening
retained earnings. The Company adopted FIN 48 effective January 1, 2007 and there was no impact on
the Companys financial statements.
Financial Statement Restatement
In September 2006, the Securities and Exchange Commission (SEC) issued Staff Accounting
Bulletin No. 108 (SAB 108). Due to diversity in practice among registrants, SAB 108 expresses SEC
staff views regarding the process by which misstatements in financial statements are evaluated for
purposes of determining whether financial statement restatement is necessary. SAB 108 is effective
for fiscal years ending after November 15, 2006. The Company adopted SAB 108 effective January 1,
2007 and there was no impact on the Companys financial statements.
3. | Stock-Based Compensation Plans |
Effective January 1, 2006, the Company adopted SFAS 123(R), which establishes accounting for
stock-based awards exchanged for employee services, using the modified prospective application
transition method. Accordingly, stock-based compensation cost is measured at grant date, based on
the fair value of the award, and is recognized over the requisite service period. Previously, the Company applied APB
25 and related Interpretations, as permitted by SFAS 123.
7
Table of Contents
For options and warrants issued to non-employees, the Company recognizes stock compensation
costs utilizing the fair value methodology prescribed in SFAS No. 123(R) over the related period of
benefit.
Determining Fair Value Under SFAS 123(R)
Valuation and Amortization Method. The Company estimates the fair value of stock-based awards
granted using the Black-Scholes option valuation model. The Company amortizes the fair value of all
awards on a straight-line basis over the requisite service periods, which are generally the vesting
periods.
Expected Life. The expected life of awards granted represents the period of time that they are
expected to be outstanding. The Company determines the expected life based on historical experience
with similar awards, giving consideration to the contractual terms, vesting schedules and
pre-vesting and post-vesting forfeitures.
Expected Volatility. The Company estimates the volatility of our common stock at the date of
grant based on the historical volatility of our common stock. The volatility factor used in the
Black-Scholes option valuation model is based on the Companys historical stock prices over the
most recent period commensurate with the estimated expected life of the award.
Risk-Free Interest Rate. The Company bases the risk-free interest rate used in the
Black-Scholes option valuation model on the implied yield currently available on U.S. Treasury
zero-coupon issues with an equivalent remaining term equal to the expected life of the award.
Expected Dividend Yield. The Company has never paid any cash dividends on common stock and
does not anticipate paying any cash dividends in the foreseeable future. Consequently, the Company
uses an expected dividend yield of zero in the Black-Scholes option valuation model.
Expected Forfeitures. The Company uses historical data to estimate pre-vesting option
forfeitures. The Company records stock-based compensation only for those awards that are expected
to vest.
The fair value of each option grant is estimated on the date of grant using the Black-Scholes
option pricing model. There were no shares purchased under the stock purchase plan during the three
months ended March 31, 2007 and 2006, respectively.
The stock-based compensation expense related to stock-based awards under SFAS 123(R) totaled
$4,000 and $1,000 for the three months ended March 31, 2007 and 2006, respectively. As of March 31,
2007, the Company had less than $1,000 of total unrecognized compensation cost related to
non-vested stock-based awards granted under all equity compensation plans.
There were no stock options granted during the three months ended March 31, 2007 and 2006.
4. | Liquidity |
Since 2004,
the Company has undergone a significant recapitalization pursuant to which Toucan Capital
Fund II, L.P. (Toucan Capital) has loaned the Company an aggregate of $6.75 million and Toucan Partners LLC, an
affiliate of Toucan Capital (Toucan Partners), has loaned the Company an aggregate of $4.1
million, including $3.15 million of contingently convertible promissory notes.
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 Series A Preferred Stock at a
purchase price of $0.04 per share, for a net purchase price of $1.267 million, net of offering
related costs of approximately $24,000. In April 2006, $6.75 million of the notes payable plus all
accrued interest due to Toucan Capital were converted into shares of
the Companys Series A-1 Preferred
Stock.
From November 14,
2005 through March 9, 2006, the Company issued three promissory notes to Toucan
Partners LLC, an affiliate of Toucan Capital, pursuant to which Toucan Partners has loaned the Company an
aggregate of $950,000. In April 2007, these notes were amended and restated to conform to the 2007
Convertible Notes and 2007 Warrants. Payment is due under the notes upon written demand on or
after June 30, 2007. Interest accrues at 10% per annum, compounded annually, on a 365-day year
basis. The principal amount of, and accrued interest on, these notes, as amended, is convertible at
Toucan Partners election into common stock or Preferred Stock on the same terms as the 2007
Convertible Notes described below.
8
Table of Contents
The
$3.15 million in cash advances received from Toucan Partners from October 2006 through
April 2007, which were converted into the 2007 Convertible Notes and 2007 Warrants in
April 2007, have enabled the Company to continue to operate and advance programs, while
attempting to raise additional
capital. Although these notes are convertible, the conversion terms will not be fixed until a
future date at Toucan Partners election. The outstanding principal and accrued interest under the
2007 Convertible Notes may be converted (in whole or in part) on conversion terms equal to the
terms of any convertible debt financing from an unaffiliated investor in an aggregate principal
amount of at least $150,000 on or before May 15, 2007 (a Qualified Debt Financing). In the event
that a Qualified Debt Financing does not occur, or Toucan Partners elects in its sole discretion to
not convert on such terms, the conversion terms shall be subject to further negotiation between the Company
and Toucan Partners.
On
March 30, 2006, the Company entered into the PIPE Financing with unrelated investors pursuant to
which it raised aggregate gross proceeds of approximately $5.5 million.
As of
April 30, 2007, the Company had less than $200,000 of cash. The Company is considered illiquid as this
cash is not sufficient to fund the recurring operating and associated financing costs for the next
month. Approximately $7.0 million of the Companys $8.2 million current liabilities at March 31, 2006 were
payable to related parties, including the manufacturing costs associated with producing its
DCVax® product candidates. The payable balance is reported net of the remaining debt
discount. The Company pays approximately $250,000 of the related party liabilities balance per month related
to manufacturing of its DCVax® product candidates. Further, during the last quarter of
2006, the Company commenced a clinical trial which has increased its current cash needs.
On May 14,
2007, the Company received a cash advance in the amount of $225,000 from Toucan Partners. The
Company and Toucan Partners are presently negotiating the terms pursuant to which this advance
will be required to be repaid. This cash advance was immediately deployed to satisfy some-but
not all- of the Companys immediate obligations and did not have a material impact on the
Companys liquidity.
These related
parties have not yet agreed to any refinancing, deferral or conversion to
equity, and may not do so. If these related party liabilities, the majority of which is currently
due, are required to be repaid in the near-term, the Companys
cash is not sufficient to fund its current
liabilities. Accordingly, the Company may not be able to continue
meeting its obligations on an ongoing
basis, if at all. 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 its stockholders. For ongoing operating
capital the Company intends to seek additional funds from Toucan Capital,
Toucan Partners, or other third parties. Neither Toucan Capital, Toucan Partners nor any other
third party is obligated to provide the Company with any additional funds. Any additional equity financing
with Toucan Capital, Toucan Partners or any other third party is likely to be dilutive to
stockholders and any debt financing, if available, may include
additional restrictive covenants. The Company does not believe that
its assets would be sufficient to satisfy the claims of all of its creditors in
full and to satisfy aggregate liquidation preferences of its preferred stock in full. Therefore, if
it were to pursue a liquidation, it is highly unlikely that any proceeds would be received by the
holders of its common stock. If the Company is unable to obtain significant additional capital in the
near-term, the Company may cease operations at any time.
There can be no
assurance that the Companys efforts to seek funding will be
successful. If the Companys capital
raising efforts are unsuccessful, its inability to obtain additional cash as needed could have a
material adverse effect on the Companys financial position,
results of operations and its ability to
continue its existence. The Companys independent auditors have indicated in their report on the financial
statements, included in the December 31, 2006 annual report on Form 10-K, that there is substantial
doubt about the Companys ability to continue as a going concern.
5. | Net Loss Per Share Applicable to Common Stockholders |
For the three
months ended March 31, 2007 and 2006, respectively, options to purchase 764,000 and
635,000 shares of common stock and warrants to purchase 166 million and 146 million shares of
common and preferred stock were not included in the computation of diluted net loss per
share because they were antidilutive. In addition, Series A and Series A-1 preferred stock
which is convertible into 225 million shares of common stock is not included in the computation
of diluted net loss per share because they were antidilutive given the Companys net loss
position. See Note 6 regarding additional shares of common or preferred stock which may be issuable
pursuant to agreements entered into subsequent to March 31, 2007.
6. | Notes Payable |
Toucan Partners Loans
From
November 14, 2005 through March 9, 2006, the Company issued three promissory notes to Toucan
Partners LLC, an affiliate of Toucan Capital, pursuant to which
Toucan Partners has loaned the Company an
aggregate of $950,000. In April 2007, these notes were amended and restated to conform to the 2007
Convertible Notes and 2007 Warrants. Payment is due under the notes upon written demand on or
after June 30, 2007. Interest accrues at 10% per annum, compounded annually, on a 365-day year
basis. The principal amount of, and accrued interest on, these notes, as amended, is convertible at
Toucan Partners election into common stock or Preferred Stock on the same terms as the 2007
Convertible Notes described below.
9
Table of Contents
Proceeds from the issuance of $950,000 senior convertible promissory notes and warrants
between November 14, 2005 and March 9, 2006 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 $587,000. 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 ranging from 4.1% to 4.4%, volatility ranging between 398% and 408%, and a
contractual life of 7 years. The value of the warrants was recorded as a deferred debt discount
against the $950,000 proceeds of the notes. In addition, a beneficial conversion feature related to
the notes was determined to be approximately $363,000. As a result, the total discount on the notes
equaled $950,000 which is being amortized over the twelve-month term of the respective notes.
Amortization of deferred debt discount of approximately $56,000 and $179,000 was recorded for the
three months ended March 31, 2007 and 2006, respectively. Interest accretion on the notes of
approximately $74,000 and $18,300 was recorded for the three months ended March 31, 2007 and 2006,
respectively.
From October 2006 through April 2007, the Company received a series of a series of cash
advances from Toucan Partners in an aggregate principal amount of $3.15 million. In April 2007,
these cash advances were converted into a new series of convertible promissory notes (and
associated warrants) (collectively the 2007 Convertible Notes and 2007 Warrants) that accrue
interest at 10% per annum from their respective original cash advance dates. The conversion terms
of these notes will not be fixed until a future date at Toucan Partners election. The outstanding
principal and accrued interest under the 2007 Convertible Notes may be converted (in whole or in
part) on conversion terms equal to the terms of any convertible debt financing from an unaffiliated
investor in an aggregate principal amount of at least $150,000 on or before May 15, 2007 (a
Qualified Debt Financing). In the event that a Qualified Debt Financing does not occur, or Toucan
Partners elects in its sole discretion to not convert on such terms, the conversion terms shall be
subject to further negotiation between the Company and Toucan Partners. These notes carry warrant
coverage of 100%. The number of warrant shares issuable upon exercise of each 2007 Warrant will be
equal to the number of shares that would be issuable if Toucan Partners elected to convert the
principal and accrued interest on the corresponding 2007 Convertible Notes determined as of the
date of repayment or conversion of such 2007 Convertible Notes. The exercise price of each 2007
Warrant will be equal to the conversion price of the corresponding 2007 Convertible Note.
Accordingly, both the number of shares issuable upon exercise of the warrants and the exercise
price of the 2007 Warrants are currently unknown.
The fair value of the conversion feature on the 2007 Convertible Notes has not been recorded
due to the existing unspecified terms. Additionally, the Company has not recorded a value for the
2007 Warrants due to the unspecified terms with respect to exercise price and number of warrants.
7. | Contingencies |
Potentially Dilutive Securities in Excess of Authorized Number of Common Shares
In accordance with EITF 00-19, the Company accounts for potential shares that can be converted
to common stock, that are in excess of authorized shares, as a liability that is recorded at fair
value. Upon finalization of the terms of the 2007 Convertible Notes and 2007 Warrants, the Company
may be required to record a liability for the fair value of potential shares in excess of
authorized shares.
Private Placement
On March 30, 2006, the Company entered into a securities purchase agreement (the Purchase
Agreement) with a group of accredited investors pursuant to which the Company agreed to sell an
aggregate of approximately 39.5 million shares of its common stock, at a price of $0.14 per share,
and to issue, for no additional consideration, warrants to purchase up to an aggregate of
approximately 19.7 million shares of Companys common stock.
Under the Purchase Agreement, the Company agreed to register for resale under the Securities
Act of 1933, as amended (the Securities Act) both the shares of common stock and the warrant
shares. The Company also agreed to other customary obligations regarding registration, including
matters relating to indemnification, maintenance of the registration statement, payment of
expenses, and compliance with state blue sky laws. The Company may be liable for liquidated
damages if the registration statement (after being declared effective) ceases to be effective in a
manner, and for a period of time, that violates the Companys obligations under the Purchase
Agreement. The amount of the liquidated damages payable to the investors is, in aggregate, one
percent (1%) of the aggregate purchase price of the shares per month, subject to a cap of ten
percent (10%) of the aggregate purchase price of the shares.
10
Table of Contents
As of April 17, 2007, the Companys registration statement ceased to be effective.
Accordingly, the Company will incur liquidated damages until the Company files a post-effective
amendment to the registration statement and such post-effective amendment is declared effective by
the SEC.
Legal Proceedings
The Company signed an engagement letter, dated October 15, 2003, with Soma Partners, LLC, or
Soma, a New Jersey-based investment bank, pursuant to which we engaged them to locate potential
investors. Pursuant to the terms of the engagement letter, any disputes arising between the parties
would be submitted to arbitration in the New York metropolitan area. A significant dispute arose
between the parties. Soma filed an arbitration claim against us with the American Arbitration
Association in New York, NY claiming unpaid commission fees of $186,000 and seeking declaratory
relief regarding potential fees for future transactions that may be undertaken by us with Toucan
Capital. We vigorously disputed Somas claims on multiple grounds. We contended that we only owed
Soma approximately $6,000.
Soma subsequently filed an amended arbitration claim, claiming unpaid commission fees of
$339,000 and warrants to purchase 6% of the aggregate securities issued to date, and seeking
declaratory relief regarding potential fees for future financing transactions which may be
undertaken by us with Toucan Capital and others, which could potentially be in excess of $4
million. Soma also requested the arbitrator award its attorneys fees and costs related to the
proceedings. We strongly disputed Somas claims and defended ourselves.
The arbitration proceedings occurred from March 8-10, 2005 and on May 24, 2005, the arbitrator
ruled in our favor and denied all claims of Soma. In particular, the arbitrator decided that we did
not owe Soma the fees and warrants sought by Soma, that we would not owe Soma fees in connection
with future financings, if any, and that we had no obligation to pay any of Somas attorneys fees
or expenses. The arbitrator agreed with us that the only amount we owed Soma was $6,702.87, which
payment we made on May 27, 2005.
On August 29, 2005, Soma filed a notice of petition to vacate the May 24, 2005 arbitration
award issued by the Supreme Court of the State of New York.
On December 30, 2005, the Supreme Court of the State of New York dismissed Somas petition,
denying Somas August 29, 2005 motion to vacate the May 24, 2005 award.
On February 3, 2006, Soma filed another notice of appeal with the Supreme Court of the State
of New York.
On December 6, 2006, we filed our brief for this appeal and on December 12, 2006, SOMA filed
its reply brief. As of the date of the filing of this report, the Supreme Court of the State of New
York has yet to act on this matter. We believe that Somas latest appeal is without merit and we
intend to vigorously defend the appeal.
Management Warrants
On November 13, 2003, we borrowed an aggregate of $335,000 from certain members of our
management. As part of this loan, the lenders received warrants exercisable to acquire an aggregate
of 3.7 million shares of our common stock. From March 2006 through May 2006, all of these warrants
were exercised for common stock on a net exercise basis, pursuant to the terms of the warrants.
Two former members of management who had participated as lenders in our management loans have
claimed that they are entitled to receive, for no additional cash consideration, an aggregate of up
to approximately 9.5 million additional shares of our common stock due to the alleged triggering of
an anti-dilution provision in the warrant agreements. We do not believe that these claims have
merit, and intend to vigorously defend such claims.
The Company has no other legal proceeding pending at this time.
11
Table of Contents
8. | Recent Accounting Pronouncements |
In September 2006, the FASB issued Statement of Financial Accounting Standards No. 157, Fair
Value Measurements (SFAS 157). SFAS 157 defines fair value, establishes a framework for measuring
fair value and expands disclosures about fair value measurements but does not require any new fair
value measurements. SFAS 157 is effective for financial statements issued for fiscal years
beginning after November 15, 2007, and interim periods within those fiscal years. We are evaluating
the possible impact of SFAS 157 on the financial statements.
In February 2007, the FASB issued Statement of Financial Accounting Standards No. 159, The
Fair Value Option for Financial Assets and Financial Liabilities, (SFAS 159). SFAS 159 permits
entities to choose to measure many financial instruments and certain other items at fair value. The
objective is to improve financial reporting by providing entities with the opportunity to mitigate
volatility in reported earnings caused by measuring related assets and liabilities differently
without having to apply complex hedge accounting provisions. SFAS 159 is effective for financial
statements issued for fiscal years beginning after November 15, 2007. We have not yet determined
the impact of adopting SFAS 159 on our financial position.
12
Table of Contents
Item. 2. Managements Discussion and Analysis of Financial Condition and Results 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 (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended
(the Exchange Act). 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 Risk Factors.
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 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. Additional activities have
included pre-clinical development of antibody drugs targeting CXCR4, a chemokine receptor that
plays a central role in all three phases of cancer progression: expansion of the primary tumor,
migration of tumor cells and establishment of distant metastases. 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 for trial to
evaluate our DCVax®-Brain product candidate as a possible treatment for Glioblastoma
Multiforme. However we do not presently have adequate resources to complete the trials once they
begin. We also have FDA approval to begin Phase I studies for several other
DCVax®-product candidates.
As of April 30, 2007, we had less than $200,000 of cash. We are considered illiquid as this
cash is not sufficient to fund the recurring operating and associated financing costs for the next
month. Approximately $7.0 million of our $8.2 million current liabilities at March 31, 2007 were
payable to related parties, including the manufacturing costs associated with producing our
DCVax® product candidates. The payable balance is reported net of the related debt
discount. We pay approximately $250,000 of the related party liabilities balance per month related
to manufacturing of our DCVax® product candidates. Further, during the last quarter of
2006, we commenced clinical trials which further increased our current cash needs.
These related parties have not yet agreed to any refinancing, deferral or conversion to
equity, and may not do so. If these related party liabilities, the majority of which is currently
due, are required to be repaid in the near-term, our cash is not sufficient to fund our current
liabilities. Accordingly, we may not be able to continue meeting our obligations on an ongoing
basis, if at all. 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. For ongoing operating capital we intend to seek additional funds from Toucan Capital,
Toucan Partners, an affiliate of Toucan Capital, or other third parties. Neither Toucan Capital,
Toucan Partners nor any other third party is obligated to provide us any additional funds. Any
additional equity financing with Toucan Capital, Toucan Partners or any other third party is likely
to be dilutive to stockholders and debt financing, if available, may include additional restrictive
covenants. We do not believe that our assets would be sufficient to satisfy the claims of all of
our creditors in full and to satisfy aggregate liquidation preferences of our preferred stock.
Therefore, if we were to pursue a liquidation, it is highly unlikely that any proceeds would be
received by our common stockholders. If we are unable to obtain significant additional capital in
the near-term, we may cease operations at any time.
Our financial statements for the year ended December 31, 2006 and three months ended March 31,
2007 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 $7.9 million,
and have a deficit accumulated during the development stage of $86.0 million, as of March 31, 2007,
that raises substantial doubt about our ability to continue as a going concern and our auditors
have issued an opinion on the December 31, 2006 financial statements which states that there is
substantial doubt about our ability to continue as a going concern.
13
Table of Contents
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations is based upon
our consolidated financial statements, which have been prepared in accordance with accounting
principles generally accepted in the United States. The preparation of these financial statements
requires us to make estimates and judgments that affect the reported amounts of assets,
liabilities, revenues and expenses and related disclosure of contingent assets and liabilities. The
critical accounting policies that involve significant judgments and estimates used in the
preparation of our financial statements are disclosed in our Annual Report on Form 10-K for the
year ended December 31, 2006. New critical accounting policies that involve significant judgments
and estimates are disclosed below.
In June 2006, the FASB issued FASB Interpretation No. 48 (FIN 48), Accounting for Uncertainty
in Income Taxesan interpretation of FASB Statement No. 109, Accounting for Income Taxes, which
clarifies the accounting for uncertainty in income taxes. FIN 48 prescribes a recognition threshold
and measurement attribute for the financial statement recognition and measurement of a tax position
taken or expected to be taken in a tax return. The interpretation requires that we recognize in the
financial statements, the impact of a tax position, if that position is more likely than not of
being sustained on audit, based on the technical merits of the position. FIN 48 also provides
guidance on derecognition, classification, interest and penalties, accounting in interim periods
and disclosure. The provisions of FIN 48 are effective beginning January 1, 2007 with the
cumulative effect of the change in accounting principle recorded as an adjustment to opening
retained earnings. The Company adopted FIN 48 effective January 1, 2007 and there was no impact on
the Companys financial statements.
In September 2006, the Securities and Exchange Commission (SEC) issued Staff Accounting
Bulletin No. 108 (SAB 108). Due to diversity in practice among registrants, SAB 108 expresses SEC
staff views regarding the process by which misstatements in financial statements are evaluated for
purposes of determining whether financial statement restatement is necessary. SAB 108 is effective
for fiscal years ending after November 15, 2006. The Company adopted SAB 108 effective January 1,
2007 and there was no impact on the Companys financial statements.
Results of Operations
Operating costs and expenses consist primarily of research and development expenses, including
clinical trial expenses when we are actively participating in clinical trials, and general and
administrative expenses.
Research and development expenses include salary and benefit expenses and costs of laboratory
supplies used in our internal research and development projects.
From our inception through March 31, 2007, we incurred costs of approximately $37.2 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 expenses include salary and benefit expenses related to
administrative personnel, cost of facilities, insurance, legal support, as well as amortization
costs of stock options granted to employees and warrants issued to consultants for their
professional services.
To date, our revenues have primarily been derived from the manufacture and sale of research
materials, contract research and development services and research grants from the federal
government. However, we currently no longer manufacture and sell research materials.
Three Months Ended March 31, 2006 and 2007
Research and Development Expense. Research and development expense increased from $0.4 million
for the three months ended March 31, 2006 to $1.3 million for the three months ended March 31,
2007. The increase in research and development expense from 2006 to 2007 is due primarily to the
initiation of our DCVax®-Brain Phase II clinical trial. In January 2007, we
began to enroll our first patients, which increased our manufacturing costs. Subject to our
ability to raise capital resources sufficient to fund such activites, we expect research and
development expenses to continue to increase as we initiate additional sites and continue to enroll
patients.
14
Table of Contents
General and Administrative Expense. General and administrative expense increased approximately
13% from $443,000 for the three months ended March 31, 2006 to $501,000 for the three months ended
March 31, 2007. This increase is due to the increased activities associated with our
DCVax®-Brain Phase II clinical trial.
Depreciation and Amortization. Depreciation and amortization was $10,000 for the three months
ended March 31, 2006 and 2007. The Company has invested minimally in new property and equipment
during the past twelve months.
Total Other Income (Expense), Net. Interest expense decreased from $982,000 for the three
months ended March 31, 2006 to $131,000 for the three months ended March 31, 2007. This decrease
was due primarily to the fact we had additional notes due to Toucan Capital as of March 31, 2006.
These Toucan Capital notes totaling $6.75 million in addition to the related accrued interest were
converted into shares of our Series A-1 Preferred Stock in April 2006. In addition, interest
expense decreased due to the fact that the discount on the outstanding notes payable at March 31,
2007 was fully amortized during the first quarter of 2007, whereas the debt discount was still
being amortized during the same quarter in the prior year.
Liquidity and Capital Resources
Since 2004, we
have undergone a significant recapitalization pursuant to which Toucan Capital
has loaned us an aggregate of $6.75 million and Toucan Partners has loaned us an
aggregate of $4.1 million as of April 30, 2007, including $3.15 million of contingently convertible
promissory notes, but not including a recent cash advance in the
amount of $225,000, discussed in more detail below under Recent
Events.
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 our Series A Preferred Stock at a
purchase price of $0.04 per share, for a net purchase price of $1.267 million, net of offering
related costs of approximately $24,000. In April 2006, $6.75 million of the notes payable plus all
accrued interest due to Toucan Capital were converted into shares of our Series A-1 Preferred
Stock.
From November 14, 2005 through March 9, 2006, we issued three promissory notes to Toucan
Partners LLC, an affiliate of Toucan Capital, pursuant to which Toucan Partners has loaned us an
aggregate of $950,000. In April 2007, these notes were amended and restated to conform to the 2007
Convertible Notes and 2007 Warrants. Payment is due under the notes upon written demand on or
after June 30, 2007. Interest accrues at 10% per annum, compounded annually, on a 365-day year
basis. The principal amount of, and accrued interest on, these notes, as amended, is convertible at
Toucan Partners election into common stock or Preferred Stock on the same terms as the 2007
Convertible Notes described below.
The $3.15 million in cash advances received from Toucan Partners from October 2006 through
April 2007, which were converted into the 2007 Convertible Notes and 2007 Warrants in April 2007,
have enabled us to continue to operate and advance programs, while attempting to raise additional
capital. Although these notes are convertible, the conversion terms will not be fixed until a
future date at Toucan Partners election. The outstanding principal and accrued interest under the
2007 Convertible Notes may be converted (in whole or in part) on conversion terms equal to the
terms of any convertible debt financing from an unaffiliated investor in an aggregate principal
amount of at least $150,000 on or before May 15, 2007 (a Qualified Debt Financing). In the event
that a Qualified Debt Financing does not occur, or Toucan Partners elects in its sole discretion to
not convert on such terms, the conversion terms shall be subject to further negotiation between us
and Toucan Partners.
On March 30, 2006, we entered into the PIPE Financing with unrelated investors pursuant to
which we raised aggregate gross proceeds of approximately $5.5 million.
As of April 30, 2007, we had less than $200,000 of cash. We are considered illiquid as this
cash is not sufficient to fund the recurring operating and associated financing costs for the next
month. Approximately $7.0 million of our $8.2 million current liabilities at March 31, 2007 were
payable to related parties, including the manufacturing costs associated with producing our
DCVax® product candidates and notes payable to Toucan Partners. The $4.1 million in notes
payable to Toucan Partners is due upon written demand on or after June 30, 2007. The majority of
the remaining payables are considered to be currently due. We pay approximately $250,000 of the
related party liabilities balance per month related to manufacturing of our DCVax®
product candidates. Further, during the last quarter of 2006, we commenced a clinical trial which
has increased our current cash needs.
15
Table of Contents
These related parties have not yet agreed to any refinancing, deferral or conversion to
equity, and may not do so. If these related party liabilities, the majority of which is currently
due, are required to be repaid in the near-term, our cash is not sufficient to fund our current
liabilities. Accordingly, we may not be able to continue meeting our obligations on an ongoing
basis, if at all. 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. For ongoing operating
capital we intend to seek additional funds from Toucan Capital, Toucan Partners, or other third
parties. Neither Toucan Capital, Toucan Partners nor any other third party is obligated to
provide us with any additional funds. Any additional equity financing with Toucan Capital, Toucan
Partners or any other third party is likely to be dilutive to stockholders and any debt financing,
if available, may include additional restrictive covenants. We do not believe that our assets would
be sufficient to satisfy the claims of all of our creditors in full and to satisfy aggregate
liquidation preferences of our preferred stock in full. Therefore, if we were to pursue a
liquidation, it is highly unlikely that any proceeds would be received by the holders of our common
stock. If we are unable to obtain significant additional capital in the near-term, we may cease
operations at any time.
There can be no assurance that our efforts to seek funding will be successful. If our capital
raising efforts are unsuccessful, our inability to obtain additional cash as needed could have a
material adverse effect on our financial position, results of operations and our ability to
continue our existence. Our independent auditors have indicated in their report on the financial
statements, included in the December 31, 2006 annual report on Form 10-K, that there is substantial
doubt about our ability to continue as a going concern.
Sources of Cash
During the three months ending March 31, 2007, we received $1.0 million in cash advances from
Toucan Partners, which were converted into the 2007 Convertible Notes and 2007 Warrants discussed
above. During the three months ended March 31, 2006, we received $2.9 million related to advanced
funding received in connection with certain investors commitments to purchase common stock as part
of the PIPE Financing and $0.3 million from the issuance of a convertible promissory note (and
related warrants) to Toucan Partners.
Uses of Cash
We used $1.3 million in cash for operating activities during the three months ended March 31,
2007, compared to $0.6 million for the three months ended March 31, 2006. The increase in cash used
in operating activities from 2006 to 2007, was primarily the result of the increase in research and
development expense associated with the initiation of our DCVax®-Brain Phase
II clinical trial. In January 2007, we began to enroll our first patients, which increased our
manufacturing costs. Subject to our ability to raise capital resources to fund such activities, we
expect research and development expenses to continue to increase as we initiate additional sites
and continue to enroll patients.
We utilized $11,000 in cash for investing activities for the purchase of property and
equipment during the three months ended March 31, 2007 compared to $16,000 provided by investing
activities during the three months ended March 31, 2006. The cash provided during the three months
ended March 31, 2006 consisted of net proceeds from the sale of property and equipment.
Recent Events
On
May 14, 2007, we received a cash advance in the amount of $225,000
from Toucan Partners. We and Toucan Partners are presently
negotiating the terms pursuant to which this advance will be required
to be repaid. This cash advance was immediately deployed to satisfy
some- but not all- of our immediate obligations and did not have a
material impact on our liquidity.
16
Table of Contents
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
Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information
required to be disclosed by us in reports that we file or submit under the Securities Exchange Act
is recorded, processed, summarized and reported within the time periods specified in the rules and
forms of the Securities and Exchange Commission and that such information is accumulated and
communicated to our management, including the Companys Chief Executive Officer and Chief Financial
Officer, as appropriate, to allow timely decisions regarding required disclosures. In designing
and evaluating the disclosure controls and procedures, management recognizes that any controls and
procedures, no matter how well designed and operated, can provide only reasonable assurance of
achieving the desired control objectives, and management necessarily is required to apply its
judgment in evaluating the cost-benefit relationship of possible controls and procedures.
(a) | Evaluation of disclosure controls, procedures, and internal controls |
Our president, 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 March
31, 2007, that our disclosure controls and procedures were not effective to provide reasonable
assurance that information we are required to disclose in our reports under the Exchange Act is
recorded, processed, summarized and reported accurately within the time periods required.
Material Weakness Identified
In connection with the preparation of our financial statements for the year ended December 31,
2006, certain significant internal control deficiencies became evident to management that, in the
aggregate, represent material weaknesses, including,
(i) | lack of independent directors for our audit committee; |
||
(ii) | lack of an audit committee financial expert; |
||
(iii) | insufficient personnel in our finance/accounting functions; |
||
(iv) | insufficient segregation of duties; and |
||
(v) | insufficient corporate governance policies. |
As part of the communications by Peterson Sullivan, PLLC, or Peterson Sullivan, with our audit
committee with respect to Peterson Sullivans audit procedures for fiscal 2006, 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.
In accordance with Section 404 of the Sarbanes-Oxley Act of 2002, we intend to take
appropriate and reasonable steps to make the necessary improvements to remediate these
deficiencies. We intend to consider the results of our remediation efforts and related testing as
part of our year-end 2007 assessment of the effectiveness of our internal control over financial
reporting. On March 1, 2007, we hired a part-time chief financial officer.
Changes in Internal Controls
During the period covered by this Report of Form 10-Q, there have not been any changes in our
internal controls that have materially affected or are reasonably likely to materially affect our
internal controls over financial reporting.
As part of a continuing effort to improve our business processes, management is evaluating its
internal controls and may update certain controls to accommodate any modifications to its business
processes or accounting procedures.
17
Table of Contents
Part II Other Information
Item 1. Legal Proceedings
Soma Arbitration
The Company signed an engagement letter, dated October 15, 2003, with Soma Partners, LLC, or
Soma, a New Jersey-based investment bank, pursuant to which we engaged them to locate potential
investors. Pursuant to the terms of the engagement letter, any disputes arising between the parties
would be submitted to arbitration in the New York metropolitan area. A significant dispute arose
between the parties. Soma filed an arbitration claim against us with the American Arbitration
Association in New York, NY claiming unpaid commission fees of $186,000 and seeking declaratory
relief regarding potential fees for future transactions that may be undertaken by us with Toucan
Capital. We vigorously disputed Somas claims on multiple grounds. We contended that we only owed
Soma approximately $6,000.
Soma subsequently filed an amended arbitration claim, claiming unpaid commission fees of
$339,000 and warrants to purchase 6% of the aggregate securities issued to date, and seeking
declaratory relief regarding potential fees for future financing transactions which may be
undertaken by us with Toucan Capital and others, which could potentially be in excess of $4
million. Soma also requested the arbitrator award its attorneys fees and costs related to the
proceedings. We strongly disputed Somas claims and defended ourselves.
The arbitration proceedings occurred from March 8-10, 2005 and on May 24, 2005, the arbitrator
ruled in our favor and denied all claims of Soma. In particular, the arbitrator decided that we did
not owe Soma the fees and warrants sought by Soma, that we would not owe Soma fees in connection
with future financings, if any, and that we had no obligation to pay any of Somas attorneys fees
or expenses. The arbitrator agreed with us that the only amount we owed Soma was $6,702.87, which
payment we made on May 27, 2005.
On August 29, 2005, Soma filed a notice of petition to vacate the May 24, 2005 arbitration
award issued by the Supreme Court of the State of New York.
On December 30, 2005, the Supreme Court of the State of New York dismissed Somas petition,
denying Somas August 29, 2005 motion to vacate the May 24, 2005 award.
On February 3, 2006, Soma filed another notice of appeal with the Supreme Court of the State
of New York.
On December 6, 2006, we filed our brief for this appeal and on December 12, 2006, SOMA filed
its reply brief. As of the date of the filing of this report, the Supreme Court of the State of New
York has yet to act on this matter. We believe that Somas latest appeal is without merit and we
intend to vigorously defend the appeal.
Management Warrants
On November 13, 2003, we borrowed an aggregate of $335,000 from certain members of our
management. As part of this loan, the lenders received warrants exercisable to acquire an aggregate
of 3.7 million shares of our common stock. From March 2006 through May 2006, all of these warrants
were exercised for common stock on a net exercise basis, pursuant to the terms of the warrants.
Two former members of management who had participated as lenders in our management loans have
claimed that they are entitled to receive, for no additional cash consideration, an aggregate of up
to approximately 9.5 million additional shares of our common stock due to the alleged triggering of
an anti-dilution provision in the warrant agreements. We do not believe that these claims have
merit, and intend to vigorously defend such claims.
We have no other legal proceeding pending at this time.
18
Table of Contents
Item 1A. Risk Factors
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 this Form 10-Q and our annual report on Form 10-K for the year ended
December 31, 2006. 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.
We will need to raise additional capital, which may not be available.
As of
April 30, 2007, we had less than $200,000 of cash. We are considered illiquid as this
cash is not sufficient to fund the recurring operating and associated financing costs for the next
month. Approximately $7.0 million of our $8.2 million current liabilities at March 31, 2007 were
payable to related parties, including the manufacturing costs associated with producing our
DCVax® product candidates
and notes payable to Toucan Partners. The $4.1 million in notes payable to Toucan Partners
is due upon written demand or after June 20, 2007. The majority of the remaining payables
are considered currently due. We pay approximately $250,000 of the
related party liabilities balance per month related to our manufacturing of
our DCVax®
product candidates. Further, during the last quarter of 2006, we
commenced clinical trials which will increase our current cash needs.
These related parties have not yet agreed to any refinancing, deferral or conversion to
equity, and may not do so. If these related party liabilities, the majority of which is currently
due, are required to be repaid in the near-term our cash is not sufficient to fund our current
liabilities. Accordingly, we may not be able to continue meeting our obligations on an ongoing
basis, if at all. 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. For ongoing operating capital we intend to seek additional funds from Toucan Capital,
Toucan Partners, an affiliate of Toucan Capital, or other third parties. Neither Toucan Capital,
Toucan Partners nor any other third party is obligated to provide us any additional funds. Any
additional financing with Toucan Capital, Toucan Partners or any other third party is likely to be
dilutive to stockholders, and any debt financing, if available, may include additional restrictive
covenants. We do not believe that our assets would be sufficient to satisfy the claims of all of
our creditors in full and to satisfy aggregate liquidation preferences of our preferred stock.
Therefore, if we were to pursue a liquidation it is highly unlikely that any proceeds would be
received by our common stockholders. If we are unable to obtain significant additional capital in
the near-term, we may cease operations at anytime.
Our auditors have issued a going concern audit opinion.
Our independent auditors have indicated in their report on our December 31, 2006 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 have reduced business umbrella, auto, crime and fiduciary, and directors and
officers liability insurance coverage.
Due to our limited resources, 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. When our finances permit and when our level of operating activities rise, our
insurance needs will be reassessed. 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 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 March
31, 2007, we had a deficit accumulated during the development stage of approximately $86.0 million.
We have had net losses applicable to common stockholders as follows:
| $5.8 million in 2003; |
| $8.5 million in 2004; |
19
Table of Contents
| $9.9 million in 2005; and |
| $1.4 million in 2006; and |
| $2.0 million in the three months ended March 31, 2007. |
We expect that these losses will continue and anticipate negative cash flows from operations
for the foreseeable future. Because of our current cash position, we will need to secure additional
funding to continue operations, and such funding may not be available on terms acceptable to us or
at all. In addition, we will need to generate revenue sufficient to cover operating expenses and
research and development costs to achieve profitability. 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 at an early stage of 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; |
| $124,000 in 2005; |
| $80,000 in 2006; and |
| we have not generated any revenue during the three months ended March 31, 2007. |
||
We have derived most of these limited revenues from: |
| the sale of research products to a single customer (and we have subsequently ceased selling research products); |
| contract research and development from related parties; and |
| research grants. |
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 may not be able to retain existing personnel.
Since September 2002, we reduced our research and administrative staff approximately 94%, from
67 employees to a remaining staff of three full-time employees and two part-time employees, as of
April 30, 2007. The uncertainty of our cash position, workforce reductions, and the volatility in
our stock price may create anxiety and uncertainty, which may adversely affect employee morale and
cause us to lose employees whom we would prefer to retain. 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 in early stages of development. None of our product candidates will be commercially
available in the U.S. prior to Food and Drug Administration, or FDA approval. Significant further
research and development, 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 our lead product candidate DCVax-Brain Success in
pre-clinical and early clinical trials does not ensure that subsequent large-scale trials will 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 FDA, approval for one or
more of our product candidates could significantly harm our business.
CLINICAL TRIALS
FOR OUR PRODUCT CANDIDATES ARE EXPENSIVE AND TIME CONSUMING, THEIR OUTCOME IS UNCERTAIN AND WE
HAVE LIMITED EXPERIENCE IN MANAGING THEM.
The process of
obtaining and maintaining regulatory approvals for new therapeutic products is expensive, lengthy
and uncertain. It can vary substantially, based upon the type, complexity and novelty of the
product involved. Accordingly, any of our current or future product candidates could take a
significantly longer time to gain regulatory approval than we expect or may never gain approval,
either of which could reduce our anticipated revenues and delay or terminate the potential
commercialization of our product candidates.
We have limited
experience in conducting and managing clinical trials. We rely on third parties to assist us in
managing and monitoring all of our clinical trials. Our reliance on these third parties may
result in delays in completing, or failure to complete, these trials if the third parties fail
to perform under the terms of our agreements with them. We may not be able to find a sufficient
alternative supplier of these services in a reasonable time period, or on commercially reasonable
terms, if at all. If we were unable to obtain an alternative supplier of these services, we might
be forced to curtail our Phase II clinical trial for DCVax-Brain.
We have no manufacturing capabilities, which could adversely impact our ability to
commercialize our product candidates.
We have no manufacturing facilities or expertise to produce our product candidates. We have
never manufactured, on a commercial scale, any of our research products. Even if one or more of our
product candidates is approved for marketing, 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.
20
Table of Contents
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. Even if one or
more of our product candidates is approved for marketing, 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 collaborators.
The success of our business strategy may partially depend upon our ability to develop and
maintain multiple collaborations and to manage them effectively. The success of our restructured
operations will depend on our ability to attract collaborators to our research initiatives and to a
lesser extent our ability to attract customers to our research products. 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 could suffer significantly.
Our success also depends partially upon the performance of our partners. We cannot directly
control the amount and timing of resources that our existing or future collaborators devote to the
research, development or marketing of our product candidates. As a result, those collaborators:
| 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 product candidates or alternative technologies in preference to ours; or |
| may dispute the ownership of products or technology developed under our collaborations. |
We may have disputes with our collaborators, 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 collaborations in the future. However,
we may be unable to successfully negotiate any additional collaborations 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.
21
Table of Contents
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, Immuno-Designed Molecules, Inc., and Antigenics
Inc. are actively involved in the research and development of cell-based cancer therapeutics. Of
these companies, we believe that only Dendreon and Cell Genesys are carrying-out Phase III clinical
trials with a cell-based therapy. No
dendritic cell-based therapeutic product is currently approved for commercial sale.
Additionally, several companies, such as Medarex, Inc., Amgen, 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. |
Most 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.
We have twenty issued and licensed patents (nine in the United States and eleven in foreign
jurisdictions) and 137 patent applications pending (15 in the United States and 122 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 various dates from 2015 to 2023.
22
Table of Contents
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, especially proprietary
information that is not covered by patents or patent applications. 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, collaborators 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.
Our competitors may assert that our products and the methods we employ are covered by U.S. or
foreign patents held by them. In addition, because patents can take many years to issue, there may
be currently pending applications, unknown to us, which may later result in issued patents that our
products may infringe. There could also be existing patents of which we are not aware that one or
more of our products may inadvertently infringe.
If we lose a patent infringement lawsuit, we could be prevented from selling our research
products or 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 sell our products 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.
23
Table of Contents
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 Toucan Partners beneficially own the vast majority of our stock and, as a
result, the trading price for our shares may be depressed and these stockholders can take actions
that may be adverse to your interests.
As of April 30, 2007, Toucan Capital beneficially owned an aggregate of approximately 360.7
million shares of our common stock issuable pursuant to conversion of Series A Preferred Stock,
Series A-1 Preferred Stock and warrants, representing beneficial ownership of approximately 85% of
our outstanding common stock, on an as-converted to common stock basis. In additional, Toucan
Partners, an affiliate of Toucan Capital, holds convertible notes in aggregate principal amount of
$4.1 million (which had accrued interest of $216,000 as of April 30, 2007). These notes are not
currently convertible for a determinable number of shares. Additionally, Toucan Partners holds a
series of warrants that are exercisable at the same price as the convertible notes are convertible,
which as noted above has not yet been fixed. Once the conversion price has been fixed, the
warrants will be exercisable for the same number of shares into which the promissory notes are
convertible (including accrued interest a the time of the conversion or repayment of the promissory
notes). The Series A Preferred Stock and Series A-1 Preferred Stock is convertible into common
stock (at the rate of 1-for-1 in the case of Series A Preferred Stock and at the rate of 1-for-40
in the case of Series A-1 Preferred Stock). 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.
Toucan Capital and Toucan Partners 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. 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.
In addition, Toucan Capital and Toucan Partners each has a right of first refusal to
participate in our future issuances of debt or equity securities. Also, 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 influence in regard to how we
conduct our business, and with its stock ownership, could influence any matters requiring
stockholder approval. This influence 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.
The finalization of the terms of the 2007 Convertible Notes and 2007 Warrants will result in
further dilution of the value of our common stock.
A noted above, the number of shares into which the 2007 Convertible Notes can be converted and
the number and price of the 2007 Warrants have not yet been determined. Upon completion of the
negotiations with Toucan Partners, the finalized terms for these notes and warrants are likely to
include additional significant dilution to the value of our existing outstanding common stock.
There may not be an active, liquid trading market for our common stock.
On December 23, 2002, our common stock was delisted from the NASDAQ National Market and our
common stock is currently listed on the Over-The-Counter Bulletin Board, or OTCBB, which is
generally recognized as being a less active market than NASDAQ. You may not be able to sell your
shares at the time or at the price desired. There may be significant consequences associated with
our stock trading on the OTCBB rather than a national exchange. The effects of not being able to
list our securities on a national exchange include:
| limited release of the market price of our securities; |
| limited news coverage; |
24
Table of Contents
| limited interest by investors in our securities; |
| volatility of our stock price due to low trading volume; |
| increased difficulty in selling our securities in certain states due to blue sky restrictions; and |
| limited ability to issue additional securities or to secure additional financing. |
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 following fluctuations in the trading prices of our
securities could result in substantial costs, divert managements attention and resources and harm
our financial condition and results of operations.
Our incorporation documents, and bylaws and stockholder rights plan may delay or
prevent a change in our management.
Our Seventh Amended and Restated Certificate of Incorporation, our Second Amended and Restated
Bylaws, as amended (or 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; |
| 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. In addition, we are party to an investor rights agreement which includes
protective provisions affording certain assurances to investors which could have the potential to
discourage a change in control.
25
Table of Contents
The resale, or the availability for resale, of the shares issued in the PIPE Financing could have a
material adverse impact on the market price of our common stock.
In March 2006, we entered into the PIPE Financing, consisting of a private placement of an
aggregate of approximately 39.5 million shares and accompanying warrants to purchase an aggregate
of approximately 19.7 million shares. In connection with the PIPE Financing, we agreed to register,
and subsequently did register, the resale of the shares of common stock sold in the PIPE Financing
and the shares underlying the warrants issued in the PIPE Financing. Although that registration
statement is no longer effective, we are required to file a post-effective amendment to the
registration statement to once again register these shares for resale. Moreover, even in the
absence of an effective registration statement covering these shares, these stockholders may
currently resell their shares pursuant to, and in accordance with the provisions of, Rule 144 under
the Securities Act. The resale of a substantial number of the shares covered by this prospectus, or
even the availability of these shares for resale, could have a material adverse impact on our stock
price.
Because our common stock is subject to penny stock rules, the market for the common stock
may be limited.
Because our common stock is subject to the SECs penny stock rules, broker-dealers may
experience difficulty in completing customer transactions and trading activity in our securities
may be adversely affected. Under the penny stock rules promulgated under the Securities Exchange
Act of 1934, as amended (the Exchange Act), broker-dealers who recommend such securities to
persons other than institutional accredited investors:
| must make a special written suitability determination for the purchaser; |
| receive the purchasers written agreement to a transaction prior to sale; |
| provide the purchaser with risk disclosure documents which identify certain risks
associated with investing in penny stocks and which describe the market for these penny
stocks as well as a purchasers legal remedies; and |
| obtain a signed and dated acknowledgment from the purchaser demonstrating that the
purchaser has actually received the required risk disclosure document before a transaction
in a penny stock can be completed. |
As a result of these rules, broker-dealers may find it difficult to effectuate customer
transactions and trading activity in our securities may be adversely affected. As a result, the
market price of our securities may be depressed, and stockholders may find it more difficult to
sell our securities.
Certain material weaknesses have been identified in our internal controls.
Peterson Sullivan, PLLC, our independent registered public accounting firm has informed us
that the following deficiencies in our internal controls constitute material weaknesses under
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:
| lack of independent directors for our audit committee; |
| lack of an audit committee financial expert; |
| insufficient personnel in our finance/accounting functions; |
| insufficient segregation of duties; and |
| insufficient corporate governance policies. |
If we fail to maintain adequate controls, our business and results of operations could be
harmed and we might not be able to provide reasonable assurance as to our financial results or meet
our reporting obligations.
26
Table of Contents
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
In a series of cash advances from Toucan Partners, the Company raised an aggregate principal
amount of $3.15 million between October 2006 through April 2007. In April 2007, these cash advances
were converted into the 2007 Convertible Notes and 2007 Warrants which accrue interest at 10% per
annum from their respective cash advance dates. Although these notes are convertible, the
conversion terms will not be fixed until a future date at Toucan Partners election. The
outstanding principal and accrued interest under the 2007 Convertible Notes may be converted (in
whole or in part) on conversion terms equal to the terms of any convertible debt financing from an
unaffiliated investor in an aggregate principal amount of at least $150,000 on or before May 15,
2007 (a Qualified Debt Financing). In the event that a Qualified Debt Financing does not occur,
or Toucan Partners, an affiliate of Toucan Capital and a controlling shareholder, elects in its
sole discretion to not convert on such terms, the conversion terms shall be subject to further
negotiation between us and Toucan Partners. These notes carry warrant coverage of 100%. The number
of warrant shares issuable upon exercise of each 2007 Warrant will be equal to the number of shares
that would be issuable if Toucan Partners elected to convert the principal and accrued interest on
the corresponding 2007 Convertible Notes determined as of the date of repayment or conversion of
such 2007 Convertible Note. The exercise price of each 2007 Warrant will be equal to the conversion
price of the corresponding 2007 Convertible Note. Accordingly, both the number of shares issuable
upon exercise of the warrants and the exercise price of the 2007 Warrants are currently unknown.
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 March
31, 2007.
Item 5. Other Information
On
May 14, 2007, the Company received a cash advance in the amount
of $225,000 from Toucan Partners. The Company and Toucan Partners are
presently negotiating the terms pursuant to which this cash advance
will be required to be repaid.
27
Table of Contents
Item 6. Exhibits
a) | Exhibits |
3.1 |
Seventh Amended and Restated Certificate of Incorporation, as amended. (3.1.) (1) | |
3.2 | Second Amended and Restated Bylaws of the Company. (3.2) (1) | |
3.3 | Certificate of Designations, Preferences and Rights of Series A Cumulative Convertible Preferred Stock, as amended. (3.3) (1) | |
3.4 | Certificate of Designations, Preferences and Rights of Series A-1 Cumulative Convertible Preferred Stock. (3.4) (1) | |
3.5 | First Amendment to Second Amended and Restated Bylaws of Northwest Biotherapeutics, Inc. (3.5) | |
*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 Chief Financial Officer (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 (Principal Executive Officer), pursuant to 18 U.S.C. section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley act of 2002. | |
**32.2 | Certification of Chief Financial Officer (Principal Financial and Accounting Officer), pursuant to 18 U.S.C. section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley act of 2002. |
(1) | Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Annual Report on Form 10-K filed on April 17, 2007. |
|
* | Filed herewith. |
|
** | Furnished herewith. |
28
Table of Contents
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) 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, in the City of Bothell, State of Washington, on May 15, 2007.
NORTHWEST BIOTHERAPEUTICS, INC. |
||||
By: | /s/ Jim D. Johnston | |||
Jim D. Johnston | ||||
Its: Chief Financial Officer | ||||
Pursuant to the requirements of the Securities Exchange Act of 1934, this report on has been
signed below by the following persons in the capacities and on the dates indicated:
Signature | Title | Date | ||
/s/ Alton L. Boynton, Ph.D. |
President and Director (Principal Executive Officer) |
May 15, 2007 | ||
/s/ Jim D. Johnston | Chief Financial Officer | May 15, 2007 | ||
Jim D. Johnston | (Principal Financial and Accounting Officer) |
29
Table of Contents
EXHIBIT INDEX
3.1 | Seventh Amended and Restated Certificate of Incorporation, as amended. (3.1.) (1) | |
3.2 | Second Amended and Restated Bylaws of the Company. (3.2) (1) | |
3.3 | Certificate of Designations, Preferences and Rights of Series A Cumulative Convertible Preferred Stock, as amended. (3.3) (1) | |
3.5 | Certificate of Designations, Preferences and Rights of Series A-1 Cumulative Convertible Preferred Stock. (3.4) (1) | |
3.5 | First Amendment to Second Amended and Restated Bylaws of Northwest Biotherapeutics, Inc. (3.5) | |
*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 Chief Financial Officer (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 (Principal Executive Officer), pursuant to 18 U.S.C. section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley act of 2002. | |
**32.2 | Certification of Chief Financial Officer (Principal Financial and Accounting Officer), pursuant to 18 U.S.C. section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley act of 2002. |
(1) | Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Annual Report on Form 10-K filed on April 17, 2007. |
|
* | Filed herewith. |
|
** | Furnished herewith. |
30