As filed with the Securities and Exchange Commission on April
, 2008
Registration No. 333-134320
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Post-Effective Amendment No. 3
to
Form S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
Northwest Biotherapeutics, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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2834
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94-3306718
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(State or other jurisdiction of
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(Primary Standard Industrial
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(I.R.S. Employer
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incorporation or organization)
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Classification Code Number)
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Identification Number)
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7600 Wisconsin Avenue, Suite 750
Bethesda, Maryland 20814
(240) 497-9024
(Address, including zip code, and telephone number, including area code, of registrants principal executive offices)
Alton L. Boynton, Ph.D.
President, Chief Executive Officer
7600 Wisconsin Avenue, Suite 750
Bethesda, Maryland 20814
(240) 497-9024
(Name, address, including zip code, and telephone number, including area code, of agent for service)
With copies to:
David H. Engvall, Esq.
Covington & Burling LLP
1201 Pennsylvania Avenue, N.W.
Washington, D.C. 20004
(202) 662-6000
Approximate date of commencement of proposed sale to the public:
From time to time after this
Registration Statement becomes effective.
If any of the securities being registered on this Form are to be offered on a delayed or
continuous basis pursuant to Rule 415 under the Securities Act of 1933, other than securities
offered only in connection with dividend or interest reinvestment plans, check the following box.
þ
If this Form is filed to register additional securities for an offering pursuant to Rule
462(b) under the Securities Act, please check the following box and list the Securities Act
registration statement number of the earlier effective registration statement for the same
offering.
o
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities
Act, check the following box and list the Securities Act registration statement number of the
earlier effective registration statement for the same offering.
o
If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities
Act, check the following box and list the Securities Act registration statement number of the
earlier effective registration statement for the same offering.
o
The Registrant hereby amends this Registration Statement on such date or dates as may be
necessary to delay its effective date until the Registrant shall file a further amendment which
specifically states that this Registration Statement shall thereafter become effective in
accordance with
Section 8(a)
of the Securities Act of 1933, as amended, or until the Registration
Statement shall become effective on such date as the Commission, acting pursuant to said Section
8(a), may determine.
The information in this prospectus is not complete and may be changed. These securities may not be
sold until the registration statement filed with the Securities and Exchange Commission is
effective. This prospectus is not an offer to sell nor does it seek an offer to buy these
securities in any jurisdiction where the offer or sale is not permitted.
SUBJECT TO COMPLETION, DATED APRIL __, 2008
PROSPECTUS
679,389 Shares
Northwest Biotherapeutics, Inc.
Common Stock
This prospectus relates to the resale, from time to time, of up to 679,389 shares of our
common stock which are held by certain of our stockholders named in this prospectus, whom we refer
to collectively as the selling stockholders. These shares include 2,000 shares of common stock held
by the selling stockholders and 677,389 shares of common stock issuable upon exercise of warrants
held by the selling stockholders. All of these shares of common stock are being sold by the selling
stockholders, or their transferees, pledgees, donees or successors-in-interest. The selling
stockholders will receive all proceeds from the sale of the shares of our common stock being
offered in this prospectus. We will, however, receive the exercise price of the warrants held by
the selling stockholders upon exercise for cash by the selling stockholders.
The selling stockholders may sell the shares of common stock being offered by them from time
to time on the Over-the-Counter Bulletin Board, in market transactions, in negotiated transactions
or otherwise, and at prices and at terms that will be determined by the then prevailing market
price for the shares of common stock or at negotiated prices directly or through brokers or
dealers, who may act as agent or as principal Illegible or by a combination of such methods of
sale. For additional information on the methods of sale, you should refer to the section entitled
Plan of Distribution on page 74.
Our common stock trades on the Over-The-Counter Bulletin Board under the symbol NWBO.OB. On
April 21, 2008, the closing price of our common stock on the Over-The-Counter Bulletin Board was
$1.95.
Investing in our common stock involves risks. See Risk Factors beginning on page 6.
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS
APPROVED OR DISAPPROVED OF THESE SECURITIES OR DETERMINED IF THIS PROSPECTUS IS TRUTHFUL OR
COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
The date of this prospectus is April , 2008.
1
TABLE OF CONTENTS
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Page No.
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PROSPECTUS SUMMARY
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3
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RISK FACTORS
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6
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
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17
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USE OF PROCEEDS
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17
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MARKET FOR COMMON STOCK
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17
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DIVIDEND POLICY
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18
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SELECTED FINANCIAL DATA
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18
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MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
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21
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QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
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31
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BUSINESS
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31
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MANAGEMENT
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51
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COMPENSATION OF EXECUTIVE OFFICERS AND DIRECTORS
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53
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TRANSACTIONS WITH RELATED PERSONS
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63
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SECURITY OWNERSHIP OF BENEFICIAL OWNERS AND SELLING STOCKHOLDERS
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66
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DESCRIPTION OF CAPITAL STOCK
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70
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SHARES ELIGIBLE FOR FUTURE SALE
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73
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PLAN OF DISTRIBUTION
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74
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LEGAL MATTERS
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75
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EXPERTS
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76
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WHERE YOU CAN FIND MORE INFORMATION
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76
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INDEX TO FINANCIAL STATEMENTS
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F-1
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You should rely only on the information contained in this document or any prospectus
supplement or to which we have referred you. Neither we nor any of the selling stockholders have
authorized anyone to provide you with information that is different. This document may only be used
where it is legal to sell these securities. The information in this document or any prospectus
supplement may only be accurate on the date of this document or any prospectus supplement.
IF IT IS AGAINST THE LAW IN ANY STATE TO MAKE AN OFFER TO SELL THESE SECURITIES, OR TO SOLICIT
AN OFFER FROM SOMEONE TO BUY THESE SECURITIES, THEN THIS PROSPECTUS DOES NOT APPLY TO ANY PERSON IN
THAT STATE, AND NO OFFER OR SOLICITATION IS MADE BY THIS PROSPECTUS TO ANY SUCH PERSON.
2
PROSPECTUS SUMMARY
This summary highlights information contained elsewhere in this prospectus. It does not
contain all of the information that you should consider before investing in our common stock. You
should read the entire prospectus carefully, including our financial statements and notes thereto.
You should read Risk Factors beginning on page 6 for more information about important risks that
you should consider before investing in our common stock.
As used in this prospectus, unless the context otherwise requires, the terms Northwest
Biotherapeutics, the Company, we, us, and our refer to Northwest Biotherapeutics, Inc. and
its subsidiary.
NORTHWEST BIOTHERAPEUTICS, INC.
General
Northwest Biotherapeutics, Inc. was formed in 1996 and subsequently incorporated in Delaware
in July 1998. We are a development stage biotechnology company focused on discovering, developing,
and commercializing immunotherapy products that generate and enhance immune system responses to
effectively treat cancer. Currently approved cancer treatments are frequently ineffective, can
cause undesirable side effects and provide marginal clinical benefits. Our approach in developing
cancer therapies utilizes our expertise in the biology of DCs, which are a type of white blood cell
that activate the immune system. Our primary activities since incorporation have been focused on
advancing a proprietary dendritic cell (DC) immunotherapy for prostate and brain cancer together
with strategic and financial planning, and raising capital to fund our operations. We completed an
initial public offering of our common stock on the NASDAQ Stock Market (NASDAQ) in December 2001,
and we completed an initial public offering of our common stock on the Alternative Investment
Market (AIM) of the London Stock Exchange in June 2007.
We have two basic technology platforms applicable to cancer therapeutics: DC-based cancer
vaccines, which we call DCVax®, and monoclonal antibodies for cancer therapeutics. DCVax® is our
registered trademark. Our DCVax® DC-based cancer vaccine program is our main technology platform.
Other Information
Our principal executive offices are located at 7600 Wisconsin Avenue, Suite 750, Bethesda,
Maryland 20814. Our telephone number is (240) 497-9024. Our website address is www.nwbio.com. The
information available on or through our website is not part of this prospectus.
THE OFFERING
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Common stock offered by the selling stockholders:
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679,389 shares (this
includes 677,389 shares
issuable upon the
exercise of warrants
held by the selling
stockholders)
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Common stock outstanding on April 21, 2008:
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42,346,839 shares
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Use of proceeds:
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We will not receive any
of the proceeds from the
sale of shares by the
selling stockholders,
but we will receive the
exercise price for
warrants held by the
selling stockholders
when such warrants are
exercised for cash. We
intend to use the net
proceeds that we receive
from the exercise of
such warrants, if any,
for working capital and
other general corporate
purposes. See Use of
Proceeds.
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Over-The-Counter Bulletin Board symbol
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NWBO.OB
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3
The common stock outstanding on April 21, 2008 excludes:
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an aggregate of 35,805 shares of common stock issuable upon exercise of stock options
outstanding at April 21, 2008, granted under our 1998 Stock Plan, the 1999 Executive Stock
Plan, the 2001 Stock Plan, the Employee Stock Purchase Plan and the 2001 Nonemployee
Director Stock Incentive Plan;
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an aggregate of 5,444,462 shares of common stock issuable upon exercise of stock options
outstanding at April 21, 2008, granted under our 2007 Stock Option Plan and an aggregate of
555,538 additional shares of common stock reserved for future grants under our 2007 Stock
Option Plan. Our Board of Directors has resolved not to grant any further stock options
under the 1998 Stock Plan, the 1999 Executive Stock Plan, the 2001 Stock Plan, the Employee
Stock Purchase Plan or the 2001 Nonemployee Director Stock Incentive Plan; and
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an aggregate of 31,702,034 shares of common stock issuable upon exercise of warrants
outstanding at April 21, 2008, including the 677,389 shares of common stock issuable upon
exercise of warrants held by the selling stockholders.
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Summary Financial Data
The summary financial data set forth below as of December 31, 2005, 2006 and 2007 and for the
years ended December 31, 2005, 2006 and 2007 are derived from our audited consolidated financial
statements included elsewhere in this prospectus. The summary financial data set forth below as of
December 31, 2004 is derived from audited financial statements not included in this prospectus. The
summary financial data should be read in conjunction with our audited consolidated financial
statements and the related notes and Managements Discussion and Analysis of Financial Condition
and Results of Operations included elsewhere in this prospectus.
4
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Period from
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March 18,
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1996
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Year Ended
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(Inception) to
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December 31,
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December 31,
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2005
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2006
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2007
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2007
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(In thousands, except per share data)
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(Unaudited)
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Statement of Operations Data:
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Total Revenues
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$
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124
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$
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80
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$
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10
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$
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2,729
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Operating Costs and Expenses
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Cost of research material sales
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12
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382
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Research and development
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4,469
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3,777
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8,778
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44,622
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General and administrative
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2,005
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2,273
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7,171
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40,138
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Depreciation and amortization
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63
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37
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19
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2,322
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Loss on facility sublease
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895
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Asset impairment loss and (gain) loss on disposal of equipment
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(10
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2,056
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Total operating costs and expenses
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6,549
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6,077
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15,968
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90,415
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Loss from operations
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(6,425
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(5,997
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(15,958
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(87,686
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)
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Other Income (expense), net
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Warrant valuation
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7,127
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6,759
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Gain on sale of intellectual property
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3,656
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Interest expense
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(3,517
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)
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(2,564
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)
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(5,629
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)
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(21,330
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)
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Interest income and other
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5
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39
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340
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1,115
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Net income (loss)
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(9,937
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)
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(1,395
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(21,247
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)
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(97,486
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)
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Issuance of common stock in connection with elimination of
Series A and Series A-1 preferred stock preferences
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(12,349
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)
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(12,349
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Modification of Series A preferred stock warrants
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(2,306
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(2,306
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Modification of Series A-1 preferred stock warrants
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(16,393
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(16,393
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Series A preferred stock dividends
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(334
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(334
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Series A-1 preferred stock dividends
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(917
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(917
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Warrants issued on Series A and Series A-1 preferred stock
dividends
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(4,664
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(4,664
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Accretion of redemption value of mandatorily redeemable
membership units and preferred stock
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(1,872
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Series A preferred stock redemption fee
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(1,700
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)
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Beneficial conversion feature of series D convertible
preferred stock
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(4,274
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Net loss applicable to common stockholders
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$
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(9,937
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$
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(1,395
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$
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(58,210
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)
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$
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(142,295
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Net loss per share applicable to common stockholders
basic and diluted
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$
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(7.82
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)
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$
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(0.39
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$
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(2.38
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Weighted average shares used in computing basic and
diluted net loss per share
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1,271
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3,562
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24,420
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December 31,
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2005
|
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2006
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2007
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Balance Sheet Data:
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Cash
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$
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352
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$
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307
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$
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7,861
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Working capital (deficit)
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$
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(11,502
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)
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$
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(5,998
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)
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$
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5,785
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Total assets
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$
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631
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$
|
504
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$
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8,706
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Long-term obligations, net of
current portion and discounts
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$
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3
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$
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|
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$
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Total stockholders equity (deficit)
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$
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(11,418
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)
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$
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(5,949
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)
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$
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5,807
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5
RISK FACTORS
Our business, operations and financial condition are subject to various risks. You should consider
carefully the following risk factors, in addition to the other information set forth in this
prospectus, before deciding to participate in the offering. If any of these risks and uncertainties
actually occur, our business, financial condition or results of operations could be materially and
adversely affected, the value of our common stock could decline, and you may lose all or part of
your investment.
We will need to raise additional capital, which may not be available.
As of March 31, 2008, we had approximately $2.2 million of cash on hand. We will need
additional capital in the near future to support and fund the research, development and
commercialization of our product candidates and to fund our other operating activities.
Specifically, we will need additional funding to complete our current DCVax®-Brain Phase II
clinical trial. We are in the process of finalizing a debt financing of up to $8.0 million
designed to cover our operating cash requirements until the fourth quarter of this year. It is
anticipated that up to $4.0 million may be available to us by the end of April, and the balance may
become available by June. We are also negotiating additional financing with several other parties,
which we hope to complete later this year. There can be no assurance that we will be able to
complete any of the financings, or that the terms for such financings will be attractive. If we
are unable to obtain additional funds on a timely basis or on acceptable terms, we may be required
to curtail or cease certain of our operations. We may raise additional funds by issuing additional
common stock or securities (equity or debt) convertible into shares of common stock, in which case,
the ownership interest of our stockholders will be diluted. Any debt financing, if available, is
likely to include restrictive covenants that could limit our ability to take certain actions.
Further, we may seek funding from Toucan Capital or Toucan Partners or their affiliates or other
third parties. Such parties are under no obligation to provide us any additional funds, and any
such funding may be dilutive to stockholders and may contain restrictive covenants. If we are
unable to obtain sufficient additional capital in the near term, we may cease operations at any
time.
We are likely to continue to incur substantial losses, and may never achieve profitability.
We have incurred net losses every year since our formation in March 1996 and had a deficit
accumulated during the development stage of approximately $142.3 million as of December 31, 2007.
We expect that these losses will continue and anticipate negative cash flows from operations for
the foreseeable future. Despite the receipt of approximately $25.9 million of net proceeds from an
offering of our common stock on AIM in June 2007, we will need additional funding, and over the
medium term we will need to generate revenue sufficient to cover operating expenses, clinical trial
expenses and some research and development costs to achieve profitability. We may never achieve or
sustain profitability.
Our auditors have issued a going concern audit opinion.
Our independent auditors have indicated in their report on our December 31, 2007 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 liquidation.
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 we 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 $10,000 in
2007. We have derived most of these limited revenues from the sale of research products to a single
customer, contract research and development for related parties, research grants and royalties from
licensing fees generated from a licensing agreement. Our limited operating history makes it
difficult to assess our prospects for generating revenues.
6
We may not be able to retain existing personnel.
We employ seven full-time employees. The uncertainty of our business prospects and the
volatility in the price of our common stock may create anxiety and uncertainty, which could
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 existing personnel, our business and financial results may
suffer.
We may not be able to attract expert personnel.
In order to pursue our product development and marketing plans, we will need additional
management personnel and personnel with expertise in clinical testing, government regulation,
manufacturing and marketing. Attracting and retaining qualified personnel, consultants and advisors
will be critical to our success. There can be no assurance that we will be able to attract
personnel on acceptable terms given the competition for such personnel among biotechnology,
pharmaceutical and healthcare companies, universities and non-profit research institutions. The
failure to attract any of these personnel could impede the achievement of our development
objectives.
We must rely at present on a single relationship with a third-party contract manufacturer, which
will limit our ability to control the availability of our product candidates in the near-term.
We rely upon a single contract manufacturer, Cognate BioServices, Inc. (Cognate). The
majority owner of Cognate is Toucan Capital Fund II, L.P. (Toucan Capital), one of our majority
stockholders. Cognate provides consulting services and is the manufacturer of our product
candidates. We have an agreement in place with Cognate pursuant to which Cognate has agreed to
provide manufacturing and other services in connection with our pivotal Phase II clinical trial for
DCVax®-Brain. The agreement requires us to make minimum monthly payments to Cognate irrespective of
whether any DCVax® products are manufactured. The agreement does not extend to providing services
in respect of commercialization of the DCVax®-Brain product, nor for other clinical trials or
commercialization of any of our other product candidates. If and to the extent we wish to engage
Cognate to manufacture our DCVax®-Brain for commercialization or any of our other product
candidates (including DCVax®-Prostate) for clinical trials or commercialization, we will need to
enter into a new agreement with Cognate or another third-party manufacturer which might not be
feasible on a timely or favorable basis. The failure to timely enroll patients in our clinical
trials will have an adverse impact on our financial results due, in part, to the minimum monthly
payments that we make to Cognate.
Problems with our contract manufacturers facilities or processes could result in a failure to
produce, or a delay in production, of adequate supplies of our product candidates. Any prolonged
interruption in the operations of our contract manufacturers facilities could result in
cancellation of shipments or a shortfall in availability of a product candidate. A number of
factors could cause interruptions, including the inability of a supplier to provide raw materials,
equipment malfunctions or failures, damage to a facility due to natural disasters, changes in U.S.
Food and Drug Administration, or FDA, regulatory requirements or standards that require
modifications to our manufacturing processes, action by the FDA or by us that results in the
halting or slowdown of production of components or finished products due to regulatory issues, the
contract manufacturer going out of business or failing to produce product as contractually required
or other similar factors. Because manufacturing processes are highly complex and are subject to a
lengthy FDA approval process, alternative qualified production capacity may not be available on a
timely basis or at all. Difficulties or delays in our contract manufacturers manufacturing and
supply of components could delay our clinical trials, increase our costs, damage our reputation
and, if our product candidates are approved for sale, cause us to lose revenue or market share if
it is unable to timely meet market demands.
Our success partly depends on existing and future collaborators.
We work with scientists and medical professionals at academic and other institutions,
including UCLA, the University of Pennsylvania, M.D. Anderson Cancer Centre and the H. Lee Moffitt
Cancer Centre, among others, some of whom have conducted research for us or have assisted in
developing our research and development strategy. We do not employ these scientists and medical
professionals. 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 that they devote time to us as 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 our products. If
these individuals do not devote sufficient
time and resources to our programs, or if they provide substantial assistance to our
competitors, our business could be seriously harmed.
7
The success of our business strategy may partially depend upon our ability to develop and
maintain our collaborations and to manage them effectively. Due to concerns regarding our ability
to continue our operations or the commercial feasibility of our personalized DCVax® product
candidates, 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.
We may have disputes with our collaborators, which could be costly and time consuming. 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 collaboration and any of these
relationships, if established, may not be scientifically or commercially successful.
We are involved in legal proceedings that could result in an adverse outcome, or that could
otherwise harm our business. In addition, future litigation could be costly to defend or pursue
and uncertain in its outcome.
We are party to various legal actions, as more fully described below under Business Legal
Proceedings. These pending legal proceedings include a dispute with Soma Partners, LLC, an
investment bank, regarding certain fees Soma claims it is entitled to under an engagement letter
with us, as well as a patent infringement claim filed against us by Lonza Group AG alleging
infringement of certain patents relating to recombinant DNA methods, sequences, vectors, cell lines
and host cells. In addition, a consolidated class action complaint has been filed against us
alleging violations of Section 10(b) of the Securities Exchange Act of 1934, as amended (the
Exchange Act), and Rule 10b-5 thereunder, based on certain of our public announcements regarding
the status of certain regulatory approvals for our DCVax®-Brain vaccine in Switzerland. We are also
cooperating with a formal Securities and Exchange Commission (SEC) investigation into the same
matter. We can provide no assurances as to the outcome of the foregoing legal proceedings.
The defense of these or future legal proceedings could divert managements attention and
resources from the needs of our business. We may be required to make substantial payments or incur
other adverse effects, in the event of adverse judgments or settlements of any such claims,
investigations, or proceedings. Any legal proceeding, even if resolved in our favor, could result
in negative publicity or cause us to incur significant legal and other expenses. Actual costs
incurred in any legal proceedings may differ from our expectations and could exceed any amounts for
which we have made reserves.
Clinical trials for our product candidates are expensive and time consuming and their outcome is
uncertain.
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 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.
Our product candidates will require a different distribution model than conventional therapeutic
products.
The nature of our product candidates means that different systems and methods will need to be
followed for the distribution and delivery of the products than is the case for conventional
therapeutic products. The personalized nature of these products, the need for
centralized storage, and the requirement to maintain the products in frozen form may mean that
we are not able to take advantage of distribution networks normally used for conventional
therapeutic products. If our product candidates are approved, it may take time for hospitals and
physicians to adapt to the requirements for handling and storage of these products, which may
adversely affect their sales.
8
We lack sales and marketing experience and as a result 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 sales,
marketing or distribution. To fully commercialize our product candidates, we will need 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.
Competition in the biotechnology and biopharmaceutical industry is intense and most of our
competitors have substantially greater resources than us.
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., Celldex
Therapeutics, Inc., Ark Therapeutics plc, Oxford Biomedica plc, Argos Therapeutics, Inc. and
Antigenics, are actively involved in the research and development of immunotherapies or 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. To our knowledge no DC-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 are
actively 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. As a result, any products developed by us may be
rendered obsolete and non-competitive.
9
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 28 issued and licensed patents (9 in the United States and 19 in other jurisdictions)
and 134 patent applications pending (17 in the United States and 117 in other jurisdictions) which
cover the use of DCs in DCVax® as well as targets for either our DC or fully human monoclonal
antibody therapy candidates. The issued patents expire at various dates from 2015 to 2026.
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 in the United States 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 U.S. 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 the 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 using 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 for 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. In addition, others may independently develop substantially equivalent proprietary information
or techniques or otherwise gain access to our trade secrets.
Our success will depend substantially 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 entered into by us 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. For example, Lonza Group AG
has filed a complaint against us in the United States District Court for the District of Maryland
alleging patent infringement. In addition, 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.
10
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 claim, 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 we 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 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 may not receive regulatory approvals for our product candidates or there may be a delay in
obtaining such approvals.
Our products and our ongoing development activities are subject to regulation by governmental
and other regulatory authorities in the countries in which we or our collaborators and distributors
wish to test, manufacture or market our products. For instance, the FDA will regulate the product
in the U.S. and equivalent authorities, such as the European Medicines Agency (EMEA), will
regulate in other jurisdictions. Regulatory approval by these authorities will be subject to the
evaluation of data relating to the quality, efficacy and safety of the product for its proposed
use.
The time taken to obtain regulatory approval varies between countries. Different regulators
may impose their own requirements and may refuse to grant, or may require additional data before
granting, an approval, notwithstanding that regulatory approval may have been granted by other
regulators. Regulatory approval may be delayed, limited or denied for a number of reasons,
including insufficient clinical data, the product not meeting safety or efficacy requirements or
any relevant manufacturing processes or facilities not meeting applicable requirements.
Further trials and other costly and time-consuming assessments of the product may be required to
obtain or maintain regulatory approval.
Medicinal products are generally subject to lengthy and rigorous pre-clinical and clinical
trials and other extensive, costly and time-consuming procedures mandated by regulatory
authorities. We may be required to conduct additional trials beyond those currently planned, which
could require significant time and expense. For example, the field of cancer treatment is evolving,
and the standard of care for a particular cancer could change while we are in the process of
conducting the clinical trials for our product candidates. Such a change in standard of care could
make it necessary for us to conduct additional clinical trials, which could delay our opportunities
to obtain regulatory approval of our product candidates.
As for all biological products, we may need to provide pre-clinical and clinical data
evidencing the comparability of products before and after any changes in manufacturing process both
during and after product approval. Regulators may require that we generate data to demonstrate that
products before or after any change are of comparable safety and efficacy if we are to rely on
studies using earlier versions of the product. DCVax®-Brain has been the subject of process changes
during the early clinical phase of its development and regulators may require comparability data
unless they are satisfied that changes in process do not affect the quality, and hence efficacy and
safety, of the product.
We plan to rely on our current DCVax®-Brain Phase II clinical trial as a single study in
support of regulatory approval. While under certain circumstances, both EMEA and the FDA will
accept a Phase II study as a single study in support of approval, it is not yet known whether they
will do so in this case. If the regulators do not consider the Phase II study adequate on its own
to support a finding of efficacy, we may be required to perform additional clinical trials in
DCVax®-Brain. There is some possibility that changes requested by the FDA could complicate the
licensing application process. Only the data for DCVax®-Brain has been discussed with European
regulators. On an informal basis, a number of European national regulators have indicated that
additional pre-clinical and clinical data could be required before the DCVax®-Brain product would
be approved. However, it is not clear whether such data will be required until formal scientific
advice is sought from the EMEA, which is the regulator that will ultimately review any application
for approval of this product. Unless the EMEA grants a deferral or a waiver, we may also be obliged
to generate clinical data in pediatric populations.
11
The FDA previously identified a number of deficiencies regarding the design of our original
proposed Phase III clinical trial for DCVax®-Prostate. We believe we remedied these deficiencies in
the new trial design for a 600-patient Phase III clinical trial, which was cleared by the FDA in
January 2005. However, we now intend to split this single 600-patient Phase III trial into two
separate 300-patient Phase III trials. These revisions in trial design may cause delay in the
development process for DCVax®-Prostate. It is not yet known whether the FDA will consider the
two-trial design sufficient for marketing approval, or whether the agency will require us to design
and carry out additional studies. If, after the Phase III studies are carried out, the FDA is not
satisfied that its concerns were adequately addressed, those studies could be insufficient to
demonstrate efficacy and additional clinical studies could be required at that time.
Any delay in completing sufficient trials or other regulatory requirements will delay our
ability to generate revenue from product sales and we may have insufficient capital resources to
support its operations. Even if we do have sufficient capital resources, our ability to generate
meaningful revenues or become profitable may be delayed.
Regulatory approval may be withdrawn at any time.
After regulatory approval has been obtained for medicinal products, the product and the
manufacturer are subject to continual review and there can be no assurance that such approval will
not be withdrawn or restricted. Regulators may also subject approvals to restrictions or
conditions, or impose post-approval obligations on the holders of these approvals, and the
regulatory status of such products may be jeopardized if we do not comply. Extensive post-approval
safety studies are likely to be a condition of the approval and will commit us to significant time
and expense.
We may fail to comply with regulatory requirements.
Our success will be dependent upon our ability, and our collaborative partners abilities, to
maintain compliance with regulatory requirements, including regulators current good manufacturing
practices (cGMP) and safety reporting obligations. The failure to comply with applicable
regulatory requirements can result in, among other things, fines, injunctions, civil penalties,
total or partial suspension of regulatory approvals, refusal to approve pending applications,
recalls or seizures of products, operating and production restrictions and criminal prosecutions.
We may be subject to sanctions if we are determined to be promoting our investigational products
prior to regulatory approval or for unapproved uses.
Laws in both the U.S. and Europe prohibit us from promoting any product that has not received
approval from the appropriate regulator, or from promoting a product for an unapproved use. If any
regulator determines that we have engaged in such pre-approval, or off-label promotion, through our
website, press releases, or other communications, the authority could require us to change the
content of those communications and could also take regulatory enforcement action, including the
issuance of a warning letter, requirements for corrective action, civil fines, and criminal
penalties. In the event of a product liability lawsuit, materials that appear to promote a product
for unapproved uses may increase our product liability exposure.
We may not obtain or maintain orphan drug status and the associated benefits, including marketing
exclusivity.
We may not receive the benefits associated with orphan drug designation. This may result from
a failure to achieve or maintain orphan drug status or the development of a competing product that
has an orphan designation for the same indication. In Europe, the orphan status of DCVax®-Brain
will be reassessed shortly prior to the product receiving any regulatory approval. The EMEA will
need to be satisfied that there is evidence that DCVax®-Brain offers a significant benefit relative
to existing therapies for the treatment of glioma if DCVax®-Brain is to maintain its orphan drug
status.
New legislation may have an adverse effect on our business.
Changes in applicable legislation and/or regulatory policies or discovery of problems with the
product, production process, site or manufacturer may result in delays in bringing products to
market, the imposition of restrictions on the products sale or manufacture, including the possible
withdrawal of the product from the market, or may otherwise have an adverse effect on our business.
12
The availability and amount of reimbursement for our product candidates and the manner in which
government and private payers may reimburse for our potential products is uncertain.
In many of the markets where we intend to operate, the prices of pharmaceutical products are
subject to direct price controls (by law) and to drug reimbursement programs with varying price
control mechanisms.
We expect that many of the patients in the United States who may seek treatment with our
products that may be approved for marketing will be eligible for coverage under Medicare, the
federal program that provides medical coverage for the aged and disabled. Other patients may be
covered by private health plans or may be uninsured. The Medicare program is administered by the
Centers for Medicare & Medicaid Services (CMS), an agency within the U.S. Department of Health
and Human Services. Coverage and reimbursement for products and services under Medicare are
determined pursuant to regulations promulgated by CMS and pursuant to CMSs subregulatory coverage
and reimbursement determinations. It is difficult to predict how CMS will apply those regulations
and subregulatory determinations to novel products such as ours.
Moreover, the methodology under which CMS makes coverage and reimbursement determinations is
subject to change, particularly because of budgetary pressures facing the Medicare program. For
example, the Medicare Prescription Drug, Improvement, and Modernization Act (the Medicare
Modernization Act), enacted in 2003, provided for a change in reimbursement methodology that has
reduced the Medicare reimbursement rates for many drugs, including oncology therapeutics. Even if
our product candidates are approved for marketing in the U.S., if we are unable to obtain or retain
coverage and adequate levels of reimbursement from Medicare or from private health plans, our
ability successfully to market such products in the U.S. will be adversely affected. The manner and
level at which the Medicare program reimburses for services related to our product candidates
(e.g., administration services) also may adversely affect our ability to market or sell any of our
product candidates that may be approved for marketing in the U.S.
In the U.S., efforts to contain or reduce health care costs have resulted in many legislative
and regulatory proposals at both the federal and state level, and it is difficult to predict which,
if any, of these proposals will be enacted, and, if so, when. Cost control initiatives by
governments or third party payers could decrease the price that we receive for any one or all of
our potential products or increase patient coinsurance to a level that makes our product candidates
unaffordable for patients. In addition, government and private health plans are more persistently
challenging the price and cost-effectiveness of therapeutic products. If third-party payers were to
determine that one or more of our product candidates is not cost-effective, this could result in
refusal to cover those products or in coverage at a low reimbursement level. Any of these
initiatives or developments could prevent us from successfully marketing and selling any of our
potential products.
In the E.U., governments influence the price of pharmaceutical products through their pricing
and reimbursement rules and control of national health care systems that fund a large part of the
cost of such products to consumers. The approach taken varies from member state to member state.
Some jurisdictions operate positive and/or negative list systems under which products may only be
marketed once a reimbursement price has been agreed. Other member states allow companies to fix
their own prices for medicines, but monitor and control company profits. The downward pressure on
health care costs in general, particularly prescription drugs, has become very intense. As a
result, increasingly high barriers are being erected to the entry of new products, as exemplified
by the role of the National Institute for Health and Clinical Excellence in the U.K. which
evaluates the data supporting new medicines and passes reimbursement recommendations to the
government. In addition, in some countries cross-border imports from low-priced markets (parallel
imports) exert commercial pressure on pricing within a country.
DCVax® is our only technology in clinical development.
Unlike many pharmaceutical companies that have a number of products in development and which
utilize many technologies, we are dependent on the success of our DCVax® platform and, potentially,
our CXCR4 antibody technology. While DCVax® technology has a number of potentially beneficial uses,
if that core technology is not commercially viable, we would have to rely on the CXCR4 technology,
which is at an early pre-clinical stage of development, for our success. If the CXCR4 technology
also fails, we currently do not have other technologies to fall back on and our business could
fail.
13
We may be prevented from using the DCVax® name in Europe.
The EMEA has indicated that DCVax® may not be an acceptable name because of the suggested
reference to a vaccine. Failure to obtain the approval for the use of the DCVax® name in Europe
would require us to market our potential products in Europe under a different name which could
impair the successful marketing of our product candidates and may have a material adverse effect on
our results of operations and financial condition.
Competing generic medicinal products may be approved.
In the E.U., there exists a process for the approval of generic biological medicinal products
once patent protection and other forms of data and market exclusivity have expired. If generic
medicinal products are approved, competition from such products may reduce sales of our products.
Other jurisdictions, including the U.S., are considering adopting legislation that would allow the
approval of generic biological medicinal products.
We may be exposed to potential product liability claims, and insurance against these claims may
not be available to us at a reasonable rate in the future, if at all.
Our business exposes us to potential product liability risks that are inherent in the testing,
manufacturing, marketing and sale of therapeutic products. Our insurance coverage may not be
adequate to cover claims against us or may not be available to us at an acceptable cost, if at all.
Regardless of their merit or eventual outcome, product liability claims may result in decreased
demand for a product, injury to our reputation, withdrawal of clinical trial volunteers and loss of
revenues. Thus, whether or not we are insured, a product liability claim or product recall may
result in losses that could be material.
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
liable for substantial damages and costs, including cleanup costs and personal injury or property
damages, and incur delays in research and production and increased operating costs.
Insurance covering certain types of claims of environmental damage or injury resulting from
the use of these materials is available but can be expensive and is limited in its coverage. We
have no insurance specifically covering environmental risks or personal injury from the use of
these materials and if such use results in liability, our business may be seriously harmed.
Toucan Capital and Toucan Partners beneficially own a majority of our shares of common stock and,
as a result, the trading price for our common
s
tock may be depressed and these stockholders can
take actions that may be adverse to the interests of other investors.
As of April 21, 2008, Toucan Capital and its affiliate, Toucan Partners, LLC (Toucan
Partners) collectively beneficially owned an aggregate of 21,872,196 shares of our common stock,
representing approximately 51.7 percent of our outstanding common stock. In addition, as of April
21, 2008, Toucan Capital may acquire an aggregate of approximately 22.0 million shares of common
stock upon exercise of warrants and Toucan Partners may acquire an aggregate of approximately 8.8
million shares of common stock upon the exercise of warrants. This significant concentration of
ownership may adversely affect the trading price of our common stock because investors often
perceive disadvantages in owning stock in companies with controlling stockholders. Toucan Capital
has 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, the managing director
of Toucan Capital is a member of the Board. In light of the foregoing, Toucan Capital can
significantly influence 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
investors.
14
Our Certificate of Incorporation and Bylaws and stockholder rights plan may delay or prevent a
change in our management.
Our Seventh Amended and Restated Certificate of Incorporation, as amended (the Certificate of
Incorporation), Third Amended and Restated Bylaws (the Bylaws) and stockholder rights plan
contain provisions that could delay or prevent a change in our management team. Some of these
provisions:
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authorize the issuance of preferred stock that can be created and issued by the Board
without prior stockholder approval, commonly referred to as blank check preferred stock,
with rights senior to those of the common stock;
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allow the Board to call special meetings of stockholders at any time but restrict the
stockholders from calling special meetings;
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authorize the Board to issue dilutive common stock upon certain events; and
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provide for a classified Board.
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These provisions could allow our Board to affect the rights of an investor since the Board can
make it more difficult for holders of common stock to replace members of the Board. Because the
Board is responsible for appointing the members of the management team, these provisions could in
turn affect any attempt to replace the current management team.
There may not be an active, liquid trading market for our common stock.
Our common stock is currently listed on the Over-The-Counter Bulletin Board, or OTCBB, and on
AIM, which are generally recognized as being less active markets than NASDAQ, the stock exchange on
which our common stock previously was listed. 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;
|
|
|
|
|
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.
|
The resale, or the availability for resale, of the shares placed in the PIPE Financing covered by
this prospectus could have a material adverse impact on the market price of our common stock.
In March 2006, we completed a private placement of an aggregate of approximately 2.6 million
shares of common stock and accompanying warrants to purchase an aggregate of approximately 1.3
million shares of common stock (the PIPE Financing). 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. This
prospectus is part of the registration statement registering such 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 of 1933, as amended (the Securities Act). The resale of a substantial number
of the shares placed in the PIPE Financing covered by this prospectus, or even the availability of
these shares for resale, could have a material adverse impact on our stock price.
15
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 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 common stock may be adversely affected. As a result, the
market price of our common stock may be depressed, and stockholders may find it more difficult to
sell our common stock.
The price of our common stock may be highly volatile.
The share price of publicly traded biotechnology and emerging pharmaceutical companies,
particularly companies without earnings and consistent product revenues, can be highly volatile and
are likely to remain highly volatile in the future. The price at which our common stock is quoted
and the price which investors may realize in sales of their shares of our common stock will be
influenced by a large number of factors, some specific to us and our operations and some unrelated
to our operating performance. These factors could include the performance of our marketing
programs, large purchases or sales of the shares, currency fluctuations, legislative changes and
general economic conditions. In the past, share class action litigation has often been brought
against companies that experience volatility in the market price of their shares. Whether or not
meritorious, litigation brought against us following fluctuations in the trading price of our
common stock could result in substantial costs, divert managements attention and resources and
harm our financial condition and results of operations.
Our business could be adversely affected by animal rights activists.
Our business activities have involved animal testing. These types of activities have been the
subject of controversy and adverse publicity. Some organizations and individuals have attempted to
stop animal testing by pressing for legislation and regulation in these areas. To the extent the
activities of such groups are successful, our business could be adversely affected. Negative
publicity about us, our pre-clinical trials and our product candidates could have an adverse impact
on our sales and profitability.
The requirements of the Sarbanes-Oxley Act of 2002 and other U.S. securities laws reporting
requirements impose cost and operating challenges on us.
We are subject to certain of the requirements of the Sarbanes-Oxley Act of 2002 in the U.S. and the
reporting requirements under the Exchange Act. These laws require, among other things, an
attestation report of our independent auditor on the effectiveness of our internal control over
financial reporting, currently expected to begin with our annual report for the year ended December
31, 2008, as well as the filing of annual reports on Form 10-K, quarterly reports on Form 10-Q and
periodic reports on Form 8-K following the happening of certain material events. To meet these
compliance deadlines, we will need to have our internal controls designed, tested and operational
to ensure compliance with applicable standards. We initiated the process of documenting and
evaluating our internal controls and financial reporting procedures in early 2008. This process is
ongoing and will continue to likely be time consuming and will result in us having to significantly
change our
controls and reporting procedures due to our small number of employees and lack of governance
controls. Most similarly-sized companies registered with the SEC have had to incur significant
costs to ensure compliance. Moreover, any failure by us to comply with such provisions would be
required to be disclosed publicly, which could lead to a loss of public confidence in our internal
controls and could harm the market price of our common stock.
16
Our management has identified significant internal control deficiencies, which management and our
independent auditor believe constitute material weaknesses.
In connection with the preparation of our financial statements for the year ended December 31,
2007, certain significant internal control deficiencies became evident to management that, in the
aggregate, represent material weaknesses, including:
|
|
|
lack of a sufficient number of independent directors on our audit committee;
|
|
|
|
|
insufficient segregation of duties in our finance and accounting functions due to limited
personnel;
|
|
|
|
|
insufficient corporate governance policies; and
|
|
|
|
|
inadequate approval and control over transactions and commitments made on our behalf by
related parties.
|
As part of the communications by our independent auditors with our audit committee with
respect to audit procedures for the year ended December 31, 2007, our independent auditors informed
the audit committee that these deficiencies constituted material weaknesses, as defined by Auditing
Standard No. 5, An Audit of Internal Control Over Financial Reporting that is Integrated with an
Audit of Financial Statements and Related Independence Rule and Conforming Amendments, established
by the Public Company Accounting Oversight Board, or PCAOB. We intend to take appropriate and
reasonable steps to make the necessary improvements to remediate these deficiencies but we cannot
be certain that we will have the necessary financing to address these deficiencies or that we will
be able to attract qualified individuals to serve on our Board and to take on key management roles
within the Company. Our failure to successfully remediate these issues could lead to heightened
risk for financial reporting mistakes and irregularities and a further loss of public confidence in
our internal controls that could harm the market price of our common stock.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus, particularly the sections entitled Prospectus Summary, Risk Factors,
Managements Discussion and Analysis of Financial Condition and Results of Operations and
Business, contains forward-looking statements within the meaning of Section 27A of the Securities
Act and Section 21E of the Exchange Act. These statements relate to future events or our future
financial performance and involve known and unknown risks, uncertainties and other factors that
might cause our actual results, levels of activity, performance or achievements to differ
materially from any future results, levels of activity, performance or achievements expressed or
implied by these forward-looking statements. These risks and other factors include those listed
under Risk Factors and elsewhere in this prospectus. In some cases, you can identify
forward-looking statements by terminology such as may, might, will, should, expects,
plans, anticipates, could, intends, target, projects, contemplates, believes,
estimates, predicts, potential, continue, the negative of these terms or other comparable
terminology.
You are encouraged to carefully review the various disclosures made by us in this prospectus
and in our previous filings with the SEC, and those factors described under Risk Factors,
beginning on page 5.
USE OF PROCEEDS
The proceeds from the sale of the common stock offered in this prospectus are solely for the
account of the selling stockholders. Accordingly, we will not receive any proceeds from the sale of
the shares by the selling stockholders. However, we will receive the exercise price of any common
stock we sell to the selling stockholders upon exercise for cash by them of their warrants. The
warrants have a provision allowing the selling stockholders to exercise them on a net (or cashless)
basis in certain circumstances. If warrants to purchase all of the underlying 677,389 shares of
common stock are exercised for cash, we would receive approximately $1,422,517 in total proceeds,
before expenses, subject to any adjustment due to the anti-dilution provisions of the warrants. The
selling stockholders are not obligated to exercise the warrants for cash or at all, and if none are
exercised for cash we will not receive any proceeds. In the event that any or all of the warrants
are exercised for cash, the proceeds will be used to fund working capital needs and for general
corporate purposes.
17
MARKET FOR COMMON STOCK
Our common stock is quoted on the OTCBB under the symbol NWBO.OB The following table
summarizes our common stocks high and low sales prices for the periods indicated as reported by
the OTCBB. Quotations on the OTCBB reflect inter-dealer prices, without retail mark-up, mark-down
or commission and may not necessarily represent actual transactions.
|
|
|
|
|
|
|
|
|
|
|
High
|
|
Low
|
Year Ending December 31, 2006
|
|
|
|
|
|
|
|
|
First Quarter
|
|
$
|
10.35
|
|
|
$
|
1.35
|
|
Second Quarter
|
|
$
|
8.25
|
|
|
$
|
3.30
|
|
Third Quarter
|
|
$
|
8.25
|
|
|
$
|
2.25
|
|
Fourth Quarter
|
|
$
|
4.50
|
|
|
$
|
0.90
|
|
Year Ending December 31, 2007
|
|
|
|
|
|
|
|
|
First Quarter
|
|
$
|
2.40
|
|
|
$
|
0.75
|
|
Second Quarter
|
|
$
|
3.75
|
|
|
$
|
1.35
|
|
Third Quarter
|
|
$
|
7.33
|
|
|
$
|
1.85
|
|
Fourth Quarter
|
|
$
|
2.90
|
|
|
$
|
2.10
|
|
Year Ending December 31, 2008
|
|
|
|
|
|
|
|
|
First Quarter
|
|
$
|
2.58
|
|
|
$
|
1.90
|
|
Second Quarter (through April 21, 2008)
|
|
$
|
2.44
|
|
|
$
|
1.95
|
|
The closing price of our common stock on April 21, 2008, as quoted on the OTCBB, was $1.95 per
share.
As of April 21, 2008 there were approximately 335 holders of record of our common stock. Such
holders include any broker or clearing agencies as holders of record but exclude the individual
stockholders whose shares are held by brokers or clearing agencies.
DIVIDEND POLICY
We have never declared or paid cash dividends on our common stock. We currently intend to
retain future earnings, if any, to fund the development and growth of our business and do not
currently anticipate paying any cash dividends on our common stock in the foreseeable future. The
payment of future dividends, if any, will be determined by our board of directors.
SELECTED FINANCIAL DATA
The following selected financial data as of December 31, 2006 and 2007 and for each of the
years ending December 31, 2005 to December 31, 2007 and as of and for the period from March 18,
1996 (inception) to December 31, 2007 is derived from our audited consolidated financial statements
included elsewhere in this prospectus. The summary financial data set forth below as of December
31, 2003 to 2005 and for each of the years ending December 31, 2003 to December 31, 2004 is derived
from audited financial statements not included in this prospectus. The financial data should be
read in conjunction with Managements Discussion and Analysis of Financial Condition and Results
of Operations, our consolidated financial statements and notes thereto and other financial
information included elsewhere in this prospectus.
18
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
From March
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,1996
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Inception) To
|
|
|
|
Years Ended December 31,
|
|
|
December 31,
|
|
|
|
2003
|
|
|
2004
|
|
|
2005
|
|
|
2006
|
|
|
2007
|
|
|
2007
|
|
|
|
(In thousands, except per share data)
|
|
Statement of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Revenues
|
|
$
|
529
|
|
|
$
|
390
|
|
|
$
|
124
|
|
|
$
|
80
|
|
|
$
|
10
|
|
|
$
|
2,729
|
|
Operating Costs and Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of research material sales
|
|
|
79
|
|
|
|
40
|
|
|
|
12
|
|
|
|
|
|
|
|
|
|
|
|
382
|
|
Research and development
|
|
|
1,624
|
|
|
|
3,621
|
|
|
|
4,469
|
|
|
|
3,777
|
|
|
|
8,778
|
|
|
|
44,622
|
|
General and administrative
|
|
|
4,059
|
|
|
|
2,845
|
|
|
|
2,005
|
|
|
|
2,273
|
|
|
|
7,171
|
|
|
|
40,138
|
|
Depreciation and amortization
|
|
|
207
|
|
|
|
132
|
|
|
|
63
|
|
|
|
37
|
|
|
|
19
|
|
|
|
2,322
|
|
Loss on facility sublease
|
|
|
174
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
895
|
|
Asset impairment loss and (gain) loss on
disposal of equipment
|
|
|
904
|
|
|
|
130
|
|
|
|
|
|
|
|
(10
|
)
|
|
|
|
|
|
|
2,056
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating costs and expenses
|
|
|
7,047
|
|
|
|
6,768
|
|
|
|
6,549
|
|
|
|
6,077
|
|
|
|
15,968
|
|
|
|
90,415
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(6,518
|
)
|
|
|
(6,378
|
)
|
|
|
(6,425
|
)
|
|
|
(5,997
|
)
|
|
|
(15,958
|
)
|
|
|
(87,686
|
)
|
Other Income (expense), net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant valuation
|
|
|
|
|
|
|
(368
|
)
|
|
|
|
|
|
|
7,127
|
|
|
|
|
|
|
|
6,759
|
|
Gain on sale of intellectual property to
Medarex
|
|
|
816
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,656
|
|
Interest expense
|
|
|
(73
|
)
|
|
|
(1,765
|
)
|
|
|
(3,517
|
)
|
|
|
(2,564
|
)
|
|
|
(5,629
|
)
|
|
|
(21,330
|
)
|
Interest income and other
|
|
|
23
|
|
|
|
3
|
|
|
|
5
|
|
|
|
39
|
|
|
|
340
|
|
|
|
1,115
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(5,752
|
)
|
|
|
(8,508
|
)
|
|
|
(9,937
|
)
|
|
|
(1,395
|
)
|
|
|
(21,247
|
)
|
|
|
(97,486
|
)
|
Issuance of common stock in connection
with elimination of Series A and Series
A-1 preferred stock preferences
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(12,349
|
)
|
|
|
(12,349
|
)
|
Modification of Series A preferred
stock warrants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,306
|
)
|
|
|
(2,306
|
)
|
Modification of Series A-1 preferred
stock warrants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(16,393
|
)
|
|
|
(16,393
|
)
|
Series A preferred stock dividends
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(334
|
)
|
|
|
(334
|
)
|
Series A-1 preferred stock dividends
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(917
|
)
|
|
|
(917
|
)
|
Warrants issued on Series A and Series
A-1 preferred stock dividends
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,664
|
)
|
|
|
(4,664
|
)
|
Accretion of redemption value of
mandatorily redeemable membership units
and preferred stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,872
|
)
|
Series A preferred stock redemption fee
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,700
|
)
|
Beneficial conversion feature of series
D convertible preferred stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,274
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) applicable to common
stockholders
|
|
$
|
(5,752
|
)
|
|
$
|
(8,508
|
)
|
|
$
|
(9,937
|
)
|
|
$
|
(1,395
|
)
|
|
$
|
(58,210
|
)
|
|
$
|
(142,295
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share applicable to common
stockholders basic and diluted
|
|
$
|
(4.56
|
)
|
|
$
|
(6.70
|
)
|
|
$
|
(7.82
|
)
|
|
$
|
(0.39
|
)
|
|
$
|
(2.38
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares used in
computing basic and diluted net loss
per share
|
|
|
1,261
|
|
|
|
1,269
|
|
|
|
1,271
|
|
|
|
3,562
|
|
|
|
24,420
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
19
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
2003
|
|
2004
|
|
2005
|
|
2006
|
|
2007
|
|
|
(In thousands)
|
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
|
|
$
|
255
|
|
|
$
|
248
|
|
|
$
|
352
|
|
|
$
|
307
|
|
|
$
|
7,861
|
|
Working capital (deficit)
|
|
$
|
(392
|
)
|
|
$
|
(5,353
|
)
|
|
$
|
(11,502
|
)
|
|
$
|
(5,998
|
)
|
|
$
|
5,785
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
871
|
|
|
$
|
558
|
|
|
$
|
631
|
|
|
$
|
504
|
|
|
$
|
8,706
|
|
Long-term obligations, net of
current portion and discounts
|
|
$
|
49
|
|
|
$
|
12
|
|
|
$
|
3
|
|
|
$
|
|
|
|
$
|
|
|
Total stockholders equity (deficit)
|
|
$
|
16
|
|
|
$
|
(5,217
|
)
|
|
$
|
(11,418
|
)
|
|
$
|
(5,949
|
)
|
|
$
|
5,807
|
|
20
MANAGEMENTS DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion should be read in conjunction with, and is qualified in its entirety
by reference to, our consolidated financial statements and the related notes included elsewhere in
this prospectus. The discussions in this section contain forward-looking statements that involve
risks and uncertainties, and actual results could differ materially from those discussed below. See
Risk Factors and Special Note Regarding Forward-Looking Statements for a discussion of these
risks and uncertainties.
Overview
Northwest Biotherapeutics, Inc. was formed in 1996 and incorporated in Delaware in July 1998.
We are a development stage biotechnology company focused on discovering, developing and
commercializing immunotherapy products that generate and enhance immune system responses to treat
cancer. Data from our clinical trials suggest that our cancer therapies significantly extend both
time to recurrence and survival, while providing a superior quality of life with no debilitating
side effects when compared with current therapies.
Our platform technology, DCVax®, uses a patients own DCs, the starter engine of the immune
system. The DCs are extracted from the body, loaded with tumor biomarkers or antigens, thereby
creating a personalized therapeutic vaccine. Injection of these cells back into the patient is
designed to initiate a potent immune response against cancer cells resulting in delayed time to
progression and prolonged survival. Our lead product candidate is DCVax®-Brain which targets
Glioblastoma Multiforme (GBM), the most lethal form of brain cancer. DCVax®-Brain has entered a
Phase II FDA-allowed clinical trial, which is designed and powered as a pivotal trial (i.e. a trial
from which a company may go directly to product approval). Following this trial, we anticipate
filing a biologic license application (BLA) with the FDA for DCVax®- Brain. DCVax®-Prostate,
which targets hormone independent (i.e. late stage) prostate cancer, has also been cleared by the
FDA to commence a Phase III clinical trial, which is also designed and powered as a pivotal trial.
A Phase I/II clinical trial using our DCVax® product for recurrent ovarian cancer was recently
initiated at the University of Pennsylvania Center for Research on Early Detection and Cure of
Ovarian Cancer and the Abramson Cancer Center (the University of Pennsylvania). 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. DCVax®-Brain has
been granted orphan drug status in both the U.S. and the European Union. Such status will afford
DCVax®-Brain 7 years of market exclusivity in the U.S. and 10 years in the European Union, if
DCVax®-Brain is the first product of its type to obtain product approval. For additional
information regarding our business, product candidates and the status of our clinical trials, see
the Business section elsewhere in this prospectus.
Our financing activities are described below under Liquidity and Capital Resources. We
will need to raise additional capital to fund our operations, including our Phase II
DCVax®-Brain clinical trial. Depending on the trial results, we plan to seek product
approval for DCVax®-Brain, our leading product candidate, in both the U.S. and E.U.
We have experienced recurring losses from operations and have a deficit accumulated during the
development stage of $142.3 million at December 31, 2007. In addition, our independent registered
public accounting firm has indicated in its report on our financial statements included elsewhere
in this prospectus that there is substantial doubt about our ability to continue as a going
concern.
Going Concern
Despite the receipt of proceeds in our offerings and subsequent financings described under
"Liquidity and Capital Resources below, we will require additional funding to achieve
profitability and there can be no assurance that our efforts to seek such 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 financial statements for the year ended
December 31, 2007 have been 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 and have a deficit accumulated during the development
stage of $142.3 million that raises substantial doubt about our ability to continue as a
going concern and our auditors have issued an opinion, for the year ended December 31, 2007,
which states that there is substantial doubt about our ability to continue as a going concern.
21
If we are unable to continue as a going concern, we would consider all opportunities for
creating value in the Company, including investigating ways to advance our dendritic cell-based
product and monoclonal antibody candidates, including pursuing potential corporate partnerships for
our monoclonal antibody candidates, and other alternatives, including the possible sale of some or
all of our assets.
Expenses
From our inception through December 31, 2007, we incurred costs of approximately $44.6 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.
Critical Accounting Policies and Estimates
The preparation of financial statements in conformity with accounting principles generally
accepted in the United States of America (GAAP) require our management to make estimates and
assumptions that affect the amounts of assets and liabilities and disclosure of contingent assets
and liabilities at the date of our financial statements, as well as the amounts of revenues and
expenses during periods covered by our financial statements. The actual amounts of these items
could differ materially from those estimates. Our accounting policies are described in more detail
in Note 3 to our consolidated financial statements for the year ended December 31, 2007, included
elsewhere herein. We have identified the following as the most critical accounting policies and
estimates used in this preparation of our consolidated financial statements.
Restructuring Liabilities
When circumstances warrant, we may elect to discontinue certain business activities or change
the manner in which we conduct ongoing operations. When such a change is made, management will
estimate the costs to exit a business or restructure ongoing operations. The components of the
estimates may include estimates and assumptions regarding the timing and costs of future events and
activities that represent managements best expectations based on known facts and circumstances at
the time of estimation. Management periodically reviews its restructuring estimates and assumptions
relative to new information, if any, of which it becomes aware. Should circumstances warrant,
management will adjust its previous estimates to reflect what it then believes to be a more
accurate representation of expected future costs. Because managements estimates and assumptions
regarding restructuring costs include probabilities of future events, such estimates are inherently
vulnerable to changes due to unforeseen circumstances, changes in market conditions, regulatory
changes, changes in existing business practices and other circumstances that could materially and
adversely affect the results of operations.
Impairment of Long-Lived Assets
As of December 31, 2007, we had approximately $19,000 of property and equipment, net of
accumulated depreciation. In accounting for these long-lived assets, we make estimates about the
expected useful lives of the assets, the expected residual values of the assets, and the potential
for impairment based on events or circumstances. The events or circumstances could include a
significant decrease in market value, a significant change in asset condition or a significant
adverse change in regulatory climate. Application of the test for impairment requires judgment.
22
Stock-Based Compensation
Effective January 1, 2006, we adopted Statement of Financial Accounting Standards, or SFAS No.
123 (revised 2004),
Share-Based Payment
(SFAS No. 123(R)), using the modified prospective method,
and therefore were not required to restate prior periods results. Under this method, we recognized
compensation expense (a) for all equity incentive awards granted prior to, but not yet vested as of
January 1, 2006, based on the grant-date fair value estimated in accordance with the original
provisions of SFAS No. 123 and Accounting Principles Board Opinion No. 25,
Accounting for Stock
Issued to Employees
(APB 25), and (b) for all equity incentive awards granted, modified or
settled subsequent to January 1, 2006, based on the grant-date fair value estimated in accordance
with the provisions of SFAS No. 123(R).
Determining the appropriate fair-value model and calculating the fair value of share-based
awards at the date of grant requires judgment. We use the Black-Scholes option pricing model to
estimate the fair value of employee stock options and rights to purchase shares under stock plans,
consistent with the provisions of SFAS No. 123(R). Option pricing models, including the
Black-Scholes model, also require the use of input assumptions, including expected volatility,
expected life, expected dividend rate, and expected risk-free rate of return. We estimate the
volatility of our common stock based on the historical volatility over the most recent period
corresponding with the estimated expected life of the award. We estimate expected life of the award
based on historical experience with similar awards, giving consideration to the contractual terms,
vesting schedules and pre-vesting and post-vesting forfeitures. Higher volatility and expected
lives result in a proportional increase to share-based compensation determined at the date of
grant. The expected dividend rate and expected risk-free rate of return are not as significant to
the calculation of fair value. Although the fair value of our share-based awards is determined in
accordance with SFAS No. 123(R) and SEC Staff Accounting Bulletin, or SAB 107,
Share-Based Payment
,
the Black-Scholes option pricing model requires the input of highly subjective assumptions, and
other reasonable assumptions could provide differing results.
In addition, SFAS No. 123(R) requires us to develop a forfeiture rate which is an estimate of
the number of share-based awards that will be forfeited prior to vesting. Quarterly changes in the
estimated forfeiture rate can potentially have a significant effect on reported share-based
compensation, as the effect of adjusting the forfeiture rate for all expense amortization after
January 1, 2006 is recognized in the period the forfeiture estimate is changed.
Revenue Recognition
We earn revenues through research grants and previously earned revenues through sale of
research materials and providing research services to third parties. Revenues from sale of research
materials are to multiple customers with whom there is no other contractual relationship and are
recognized when shipped to the customer and title has passed.
Research contracts and grants require us to perform research activities as specified in each
respective contract or grant on a best efforts basis, and we are paid based on the fees stipulated
in the respective contracts and grants which approximate the costs incurred by us in performing
such activities. We recognize revenue under the research contracts and grants based on completion
of performance under the respective contracts and grants where no ongoing obligation on our part
exists. Direct costs related to these contracts and grants are reported as research and development
expenses.
Results of Operations
Operating costs:
Operating costs and expenses consist primarily of research and development expenses, including
clinical trial expenses which rise when we are actively participating in clinical trials, and
general and administrative expenses.
Research and development:
Discovery and preclinical research and development expenses include scientific personnel
related salary and benefit expenses, costs of laboratory supplies used in our internal research and
development projects, travel,
regulatory compliance, and expenditures for preclinical and clinical trial operation and
management when we are actively engaged in clinical trials.
23
Because we are a development stage company, we do not allocate research and development costs
on a project basis. We adopted this policy, in part, due to the unreasonable cost burden associated
with accounting at such a level of detail and our limited number of financial and personnel
resources. We shifted our focus, starting in 2002, from discovering, developing, and
commercializing immunotherapy products to conserving cash and primarily concentrating on securing
new working capital to re-activate our two DCVax® clinical trial programs. Our business judgment
continues to be that there is little value associated with evaluating expenditures at the project
level since all projects have either been discontinued and/or their respective activity reduced to
a subsistence level.
General and administrative:
General and administrative expenses include administrative personnel related salary and
benefit expenses, cost of facilities, insurance, travel, legal support, property and equipment
depreciation, amortization of stock options and warrants, and amortization of debt discounts and
beneficial conversion costs associated with our debt financing.
Year Ended December 31, 2006 Compared to the Year Ended December 31, 2007
For the year ended December 31, 2007, our loss from operations was approximately $16.0
million, compared to $6.0 million for the year ended December 31, 2006. Approximately 55% of our
expended resources in 2007 were apportioned to the re-activation of our two DCVax® protocols and
other research and development ventures. From our inception through December 31, 2007, we incurred
costs of approximately $44.6 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.
Total Revenues.
Revenues decreased 88% from $80,000 for the year ended December 31, 2006 to
$10,000 for the year ended December 31, 2007. The overall decrease is primarily due to the fact we
completed a sale of certain license rights during 2006 which was not duplicated in 2007.
Research and Development Expense.
Research and development expense increased 132% from $3.8
million for the year ended December 31, 2006 to $8.8 million for the year ended December 31, 2007.
This increase was primarily due to an increase in monthly contract manufacturing costs, as well as
an increase in support costs related to the development of a clinical trial program and potential
compassionate use/named patient programs in Switzerland and elsewhere. In January 2007, we began
to prepare for the enrollment of our first patients in our Phase II DCVax®-Brain clinical trial,
which increased our pre-manufacturing costs. These costs have continued to increase as we initiate
additional sites and prepare to and enroll new patients in this clinical trial.
General and Administrative Expense.
General and administrative expense increased 215% from
$2.3 million for the year ended December 31, 2006 to $7.2 million for the year ended December 31,
2007. In addition to higher staffing costs and costs associated with our AIM listing requirements
in the United Kingdom. In addition, this increase was due to increased legal fees, specifically
board of directors and insurance costs, general and administrative costs increased due to a number
of potentially non-recurring costs including, start-up costs, mainly consulting and travel costs,
due to expansion of our business activities in the United States and internationally, specifically
in Switzerland, Spain and Israel; legal costs associated with pending lawsuits and our maintenance
of patent applications in the United States and internationally. Finally, in connection with
appointing new board members in 2007, we have increased our insurance coverage resulting in
increased insurance ongoing litigation; and FAS 123(R) expense associated with stock option grants
to executives.
Depreciation and Amortization.
Depreciation and amortization decreased 49% from $37,000 for
the year ended December 31, 2006 to $19,000 for the year ended December 31, 2007. This decrease was
primarily due to the fact that our remaining assets are either fully depreciated or were previously
impaired. We acquired a minimal amount of new assets during the year ended December 31, 2007.
Total Other Income (Expense), Net.
Interest expense increased from approximately $2.6 million
for the year ended December 31, 2006 to $5.6 million for the year ended December 31, 2007. Interest
expense is primarily related to the debt discount and interest accretion associated with our
outstanding convertible promissory notes and warrants. Interest expense increased significantly
during the year ended December 31, 2007 compared to the same period in the prior year due to the
immediate amortization of the debt
discount associated with the June 1, 2007 amendment to certain convertible notes payable to
Toucan Partners. In addition, we recorded a warrant valuation gain of $7.1 million during the year
ended December 31, 2006 with respect to the revaluation of the potential shares that could be
issued in excess of the available authorized shares. See Warrant Valuation below for further
discussion. We did not have a similar gain or loss during the year ended December 31, 2007.
24
Year Ended December 31, 2005 Compared to the Year Ended December 31, 2006
Total Revenues.
Revenues decreased 36% from $124,000 for the year ended December 31, 2005 to
$80,000 for the year ended December 31, 2006. The overall decrease is primarily due to the fact we
completed two research grants in 2005, offset by a one time sale of certain license rights during
2006.
Research and Development Expense.
Research and development expense decreased 16% from
approximately $4.5 million for the year ended December 31, 2005 to $3.8 million for the year ended
December 31, 2006. This decrease was primarily due to a decrease in contract manufacturing costs.
General and Administrative Expense.
General and administrative expense increased 13% from
approximately $2.0 million for the year ended December 31, 2005 to $2.3 million for the year ended
December 31, 2006. This increase was primarily due to an increase in SEC filing costs and initial
investigations into establishing a European presence.
Depreciation and Amortization.
Depreciation and amortization decreased 41% from $63,000 for
the year ended December 31, 2005 to $37,000 for the year ended December 31, 2006. This decrease was
primarily due to the fact that our remaining assets are either fully depreciated or were previously
impaired. We did not acquire any new assets during the year ended December 31, 2006.
Total Other Income (Expense), Net.
Interest expense decreased from approximately $3.5 million
for the year ended December 31, 2005 to $2.6 million for the year ended December 31, 2006. This
decrease was due primarily to the fact that the Toucan Capital and management loans were converted
into equity in April 2006, offset by the fact that the average note payable balance was higher
prior to conversion in 2006 as compared to the balances outstanding during the year ended December
31, 2005. Additionally, we recorded a warrant valuation gain of $7.1 million during 2006 with
respect to the revaluation of the potential shares that could be issued in excess of the available
authorized shares. We did not have a similar gain during 2005.
Warrant Valuation.
In accordance with Emerging Issues Task Force, or EITF, 00-19, we account
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. Total potential outstanding common stock
exceeded our authorized shares as of December 31, 2005 when we entered into another convertible
promissory note and warrant agreement with Toucan Partners on December 30, 2005. The fair value of
the warrants in excess of the authorized shares at December 31, 2005 totaling approximately
$604,000 was recognized as a liability on December 31, 2005. This liability was required to be
remeasured at each reporting date with any change in value included in other income/(expense) until
such time as enough shares were authorized to cover all potentially convertible instruments.
Accordingly, during the first quarter of 2006, we recognized a loss totaling $2.1 million with
respect to the revaluation of this warrant liability. Further, during March 2006, we issued an
additional warrant to Toucan Partners, along with a convertible promissory note. The fair value of
the warrants in excess of the authorized shares was approximately $6.7 million and was recognized
as an additional liability as of March 31, 2006. During April 2006, we sold common stock to outside
investors in the PIPE Financing. In addition, members of management and Toucan Capital elected to
convert their promissory notes and related accrued interest into common stock and shares of our
Series A-1 cumulative convertible preferred stock (the Series A-1 Preferred Stock), respectively.
As a result, the fair value of the potential common stock in excess of the authorized shares was
$24.4 million and was recognized as an additional liability during April 2006.
Effective May 25, 2006, the number of authorized shares of common stock was increased to 800
million. The liability for potential shares in excess of total authorized shares was revalued at
that date. This valuation resulted in a gain of approximately $7.1 million during year ended
December 31, 2006, due to the net decreases in the net fair value of the related warrants on the
date the authorized shares were increased. This gain is included in the statement of operations as
a warrant valuation. As we exceeded our authorized shares of common stock on December 31, 2005, no
corresponding charges to the statement of operations were recorded for the year ended December 31,
2005.
25
Liquidity and Capital Resources
Toucan Capital and Toucan Partners
Since 2004, we have undergone a significant recapitalization pursuant to which Toucan Capital
loaned us an aggregate of $6.75 million and Toucan Partners loaned us an aggregate of $4.825
million (excluding $225,000 in proceeds from a demand note that was received on June 13, 2007 and
repaid on June 27, 2007). Our Chairperson, Linda F. Powers, is the managing director of Toucan
Capital and the managing member of Toucan Partners.
On January 26, 2005, we entered into a securities purchase agreement with Toucan Capital
pursuant to which it purchased 32.5 million shares of our Series A cumulative convertible preferred
stock (the Series A Preferred Stock) at a purchase price of $0.04 per share, for a net purchase
price of $1.276 million, net of offering related costs of approximately $24,000. In April 2006, the
$6.75 million of notes payable plus all accrued interest due to Toucan Capital were converted into
shares of our Series A-1 Preferred Stock.
Simultaneously with Toucan Capitals notes payable conversion, Alton L. Boynton, our President
and Chief Executive Officer, and Marnix Bosch, our Chief Technical Officer, each elected to convert
the principal and accrued interest on certain convertible promissory notes held by each of them
into 146,385 and 32,796 shares, respectively, of our common stock. In conjunction with the PIPE
Financing, Drs. Boynton and Bosch exercised certain warrants held by each of them on a net exercise
basis for 126,365 and 28,311 shares of our common stock, respectively.
The $4.825 million loaned to us by Toucan Partners was advanced in a series of transactions.
From November 14, 2005 through March 9, 2006, we issued three promissory notes to Toucan Partners,
pursuant to which Toucan Partners loaned us an aggregate of $950,000. In addition to the $950,000
of promissory notes, Toucan Partners provided $3.15 million in cash advances from October 2006
through April 2007, which were converted into convertible notes (the 2007 Convertible Notes) and
related warrants (the 2007 Convertible Warrants) in April 2007. In April 2007, the three
promissory notes were amended and restated to conform to the 2007 Convertible Notes. Payment was
due under the notes upon written demand on or after June 30, 2007. Interest accrued at 10% per
annum, compounded annually, on a 365-day year basis. The principal amount of, and accrued interest
on, these notes, as amended, was convertible at Toucan Partners election into common stock on the
same terms as the 2007 Convertible Notes.
Toucan Partners also entered into two promissory notes with us to fix the terms of two
additional cash advances provided by Toucan Partners to us on May 14, 2007 and May 25, 2007 in the
aggregate amount of $725,000, and we issued warrants to purchase shares of our common stock to
Toucan Partners in connection with each such note. These notes and warrants are on the same terms
as the 2007 Convertible Notes and 2007 Warrants and the proceeds of these notes enabled us to
continue to operate and advance programs while raising additional equity financing.
During the fourth quarter of 2007, we repaid the entire $5.3 million in principal and related
accrued interest due to Toucan Partners pursuant to the convertible notes.
Conversion of Preferred Stock and Related Matters
On June 1, 2007, we issued to Toucan Capital a new warrant to purchase our Series A-1
Preferred Stock (Toucan Capital Series A-1 Warrant) in exchange for the cancellation of all
previously issued warrants to purchase Series A-1 Preferred Stock (or, at the election of Toucan
Capital, any other equity or debt security of ours) held by Toucan Capital. The new Toucan Capital
Series A-1 Warrant is exercisable for 6,471,333 shares of Series A-1 Preferred Stock plus shares of
Series A-1 Preferred Stock attributable to accrued dividends on the shares of Series A-1 Preferred
Stock held by Toucan Capital (with each such Series A-1 Preferred Share convertible into 2.67
shares of common stock at $0.60 per share), compared to the 3,062,500 shares of Series A-1
Preferred Stock (with each such Series A-1 Preferred Share convertible into 2.67 shares of common
stock at $0.60 per share) that were previously issuable to Toucan Capital upon exercise of the
warrants being cancelled.
Also on June 1, 2007, we and Toucan Capital amended Toucan Capitals warrant to purchase
Series A Preferred Stock (the Toucan Capital Series A Warrant) to increase the number of shares
of Series A Preferred Stock that are issuable upon exercise of the warrant to 32,500,000 shares of
Series A Preferred Stock (plus shares of Series A Preferred Stock attributable to accrued dividends
on the shares of Series A Preferred Stock held by Toucan Capital) from 13,000,000 shares of Series
A Preferred Stock.
26
In connection with the modifications of the Series A and Series A-1 Preferred Stock warrants,
we recognized reductions in earnings applicable to common stockholders in June 2007 of $2.3 million
and $16.4 million, respectively. The fair value of the warrant modifications were determined using
the Black-Scholes option pricing model with the following assumptions: expected dividend yield of
0%, risk-free interest rate of 5.0% volatility of 398%, and a contractual life of seven years.
On June 15, 2007, we, Toucan Capital, and Toucan Partners entered into a conversion agreement
(Conversion Agreement) which became effective on June 22, 2007 upon the admission of our common
stock to trade on AIM (Admission).
Pursuant to the terms of the Conversion Agreement (i) Toucan Capital agreed to convert and has
converted all of its shares of our Series A Preferred Stock and Series A-1 Preferred Stock (in each
case, excluding any accrued and unpaid dividends) into common stock and agreed to eliminate a
number of rights, preferences and protections associated with the Series A Preferred Stock and
Series A-1 Preferred Stock, including the liquidation preference entitling Toucan Capital to
certain substantial cash payments and (ii) Toucan Partners agreed to eliminate all of its existing
rights to receive Series A-1 Preferred Stock under certain notes and warrants (and thereafter to
receive shares of common stock rather than shares of Series A-1 Preferred Stock), and the rights,
preferences and protections associated with the Series A-1 Preferred Stock, including the
liquidation preference that would entitle Toucan Partners to certain substantial cash payments. In
return for these agreements, we issued to Toucan Capital and Toucan Partners 4,287,851 and
2,572,710 shares of common stock, respectively. In connection with the issuance of these shares, we
recognized a further reduction of earnings applicable to common stockholders of $12.3 million in
June 2007.
Under the terms of the Conversion Agreement (i) the Toucan Capital Series A Warrant became
exercisable for 2,166,667 shares of common stock rather than shares of Series A Preferred Stock
(plus shares of common stock, rather than shares of Series A Preferred Stock, attributable to
accrued dividends on the shares of Series A Preferred Stock previously held by Toucan Capital that
were converted into common stock upon Admission, subject to the further provisions of the
Conversion Agreement as described below) and (ii) the Toucan Capital Series A-1 Warrant became
exercisable for an aggregate of 17,256,888 shares of common stock rather than shares of Series A-1
Preferred Stock (plus shares of common stock, rather than shares of Series A-1 Preferred Stock,
attributable to accrued dividends on the shares of Series A-1 Preferred Stock previously held by
Toucan Capital that were converted into common stock upon Admission), subject to further provisions
of the Conversion Agreement as described below.
As noted above, the 32,500,000 shares of Series A Preferred Stock held by Toucan Capital
converted, in accordance with their terms, into 2,166,667 shares of common stock and the 4,816,863
shares of Series A-1 Preferred Stock held by Toucan Capital converted, in accordance with their
terms, into 12,844,968 shares of common stock.
Under the terms of the Conversion Agreement, Toucan Capital also agreed to temporarily defer
receipt of the accrued and unpaid dividends on its shares of Series A Preferred Stock and Series
A-1 Preferred Stock of an amount equal to $334,340 and $917,451, respectively, until not later than
September 30, 2007. In September 2007, we paid these dividends in full to Toucan Capital.
As a result of the financings described above, as of December 31, 2007, Toucan Capital held:
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|
|
an aggregate of 19,299,486 shares of common stock;
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|
|
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|
warrants to purchase 14,150,732 shares of common stock at an exercise price of $0.60 per
share; and
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|
|
|
|
warrants to purchase 7,884,357 shares of common stock at an exercise price of $0.15 per
share.
|
As a result of the financings described above, as of December 31, 2007, Toucan Partners held:
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|
an aggregate of 2,572,710 shares of common stock; and
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warrants to purchase 8,832,541 shares of common stock at an exercise price of $0.60 per
share.
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The investments made by Toucan Capital and Toucan Partners were made pursuant to the terms and
conditions of a Recapitalization Agreement originally entered into on April 26, 2004 with Toucan
Capital. The Recapitalization Agreement, as
amended, originally contemplated the investment of up to $40 million through the issuance of
new securities to Toucan Capital and a syndicate of other investors to be determined.
27
We and Toucan Capital amended the Recapitalization Agreement in conjunction with each
successive loan agreement. The amendments generally (i) updated certain representations and
warranties of the parties made in the Recapitalization Agreement, and (ii) made certain technical
changes in the Recapitalization Agreement in order to facilitate the bridge loans described
therein.
In accordance with the Recapitalization Agreement, we accrued and paid certain legal and other
administrative costs on Toucan Capitals behalf. During the year ended December 31, 2007, we
recognized approximately $1.0 million of general and administrative costs related to this
recapitalization agreement and to certain other costs incurred by Toucan Capital on our behalf.
Approximately $175,000 of these costs relate to activities which took place prior to 2007. Pursuant
to the terms of the Conversion Agreement, the Recapitalization Agreement was terminated on June 22,
2007.
As of December 31, 2007, Toucan Capital, including the holdings of Toucan Partners,
beneficially owned 21,872,196 shares of our capital stock, representing approximately 51.7% of our
outstanding common stock.
Other Financing
On November 13, 2003, we borrowed an aggregate of $335,000 from certain members of our current
and former management. These notes were either been repaid or converted into common stock prior to
December 31, 2006.
On March 30, 2006, we completed the PIPE Financing pursuant to which we raised aggregate gross
proceeds of approximately $5.5 million.
On June 22, 2007, we placed 15,789,473 shares of our common stock with foreign institutional
investors at a price of £0.95 per share. The gross proceeds from the placement were approximately
£15.0 million, or $29.9 million, while net proceeds from the offering, after deducting commissions
and expenses, were approximately £13.0 million, or $25.9 million. The net proceeds from the
placement are being used to fund clinical trials, product and process development, working capital
needs and repayment of certain existing debt.
We submitted an application to the FDA for cost recovery for our Phase II trial in brain
cancer. Approval of this application would permit us to charge patients or their insurers for the
direct costs of manufacturing DCVax®-Brain during this clinical trial. However because
we have changed the study design to include a placebo control arm we have no ability to charge
patients for DCVax®-Brain without unblinding the study and as a result, have ceased
pursuing this application.
As of March 31, 2008, we had approximately $2.2 million of cash on hand. We will need to raise
additional capital in the near future to fund our clinical trials and other operating activities.
We are in discussions with multiple parties regarding potential funding transaction. However, these
parties are not obligated to provide such financing.
We estimate that our available cash is sufficient to enable us to proceed with our continuing
activities under our pivotal DCVax®-Brain trial and begin treating patients with the DCVax®-Brain
vaccine pursuant to the BAG Authorisation. Although we believe that we have funding available to
pursue the activities described above, its adequacy will depend on many factors, including the
speed with which we are able to identify and hire people to fill key positions, the speed of
patient enrollment in our pivotal brain cancer trial, the timing of the clearance by Swissmedic and
subsequent potential adoption of DCVax®-Brain in the selected hospitals in Switzerland, the cost of
establishing clinical studies and compassionate use/named patient programs in other countries and
unanticipated developments, including potential adverse developments in pending litigation matters.
However, without additional capital, we will not be able to complete our DCVax®-Brain clinical
trial or move forward with any of our other product candidates for which investigational new drug
applications have been cleared by the FDA. We will also be constrained in developing our second
generation manufacturing processes, which offer substantial product cost reductions.
Additional funding will be required in the near future and there can be no assurance that our
efforts to seek such 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 registered
public accounting firm has indicated in its report on our financial statements included in the
Annual Report on Form 10-K for the year ended December 31, 2007 that there is substantial doubt
about our ability to continue as a going concern. We may seek additional funds through the
issuance of additional common stock or other securities (equity or debt) convertible into shares of
common stock, which could dilute the ownership interest of our stockholders. We may seek funding
from Toucan Capital or Toucan Partners or their affiliates or other third parties. Such parties are
under no obligation to provide us any additional funds, and any such funding may be dilutive to
stockholders and may contain restrictive covenants that could limit our ability to take certain
actions.
28
Sources of Cash
During the year ended December 31, 2007, we received $2.375 million in cash advances from
Toucan Partners, which were converted into the 2007 Convertible Notes and 2007 Warrants discussed
above. Additionally, we received $225,000 from Toucan Partners on June 13, 2007 in the form of a
$225,000 demand note bearing interest of 10% (Demand Note). The Demand Note was repaid on June
27, 2007.
On June 22, 2007, we placed 15,789,473 shares of our common stock with foreign institutional
investors at a price of £0.95 per share. The gross proceeds from the placement were approximately
£15.0 million, or $29.9 million, while net proceeds from the offering, after deducting commissions
and expenses, were approximately £13.0 million, or $25.9 million. The placement of these shares is
the primary contributor to the $22.2 million of cash generated from financing activities during the
year ended December 31, 2007.
We generated $6.9 million in cash from financing activities for the year ended December 31,
2006, primarily from the loans from Toucan Capital and the sale of approximately 2.6 million shares
of our common stock (and the issuance of warrants to purchase an additional 1.3 million shares of
common stock at $2.10 per share) to a group of accredited investors at a price of $2.10 per share.
We generated $4.2 million in cash from financing activities during the year ended December 31, 2005
consisting of (i) the January 26, 2005 sale of our Series A Preferred Stock to Toucan Capital at a
purchase price of $0.04 per share, for a net purchase price of $1.276 million, net of issue related
costs of approximately $24,000, (ii) loans in the aggregate amount of $2.4 million from Toucan
Capital, and (iii) loans in the aggregate amount of $650,000 from Toucan Partners.
License Fees
On July 1, 2003, we entered into a license agreement with DakoCytomation California, Inc.,
under which we received a one-time $25,000 license fee and are entitled to receive minimum annual
royalty payments of $10,000. Annual royalty payments of $10,000 per year were recognized as
revenue in both 2006 and 2007. During 2006, we also sold certain license rights for a one-time fee
of $70,000.
Uses of Cash
We used $14.6 million in cash for operating activities during the year ended December 31,
2007, compared to $6.9 million for the year ended December 31, 2006. The increase in cash used in
operating activities was a result of the significant increase development activities, including
increased staffing and consulting support related to manufacturing start-up, initiating the Phase
II study for DCVax®-Brain, exploration and implementation of commercialization in Switzerland,
exploration of compassionate use/named patient programs outside of the United States, and a
decrease in accounts payable and accrued liability balances at December 31, 2007 due to our
improved funding.
We generated $17,000 in cash from investing activities during the year ended December 31, 2006
compared to $24,000 used in investing activities during the year ended December 31, 2007. The cash
provided during the year ended December 31, 2006 consisted of net proceeds from the sale of
property and equipment and the cash used during the year ended December 31, 2007 consisted of
purchases of property and equipment.
We used $4.2 million in cash for operating activities during the year ended December 31, 2005,
compared to $6.9 million for the year ended December 31, 2006. The increase of approximately 65.7%
reflects the increased level of expenditures and business activity associated with identifying
future clinical trial sites, research and development expenditures related to preclinical
activities, and gradual re-implementation of the contract manufacturing process for our two DCVax
®
clinical trial vaccines.
29
Contractual Obligations
On November 4, 2005, we entered into a sublease agreement with The International Union of
Operating Engineers Local 302 for 2,325 square feet of administrative space in a building located
in Bothell, Washington. The initial sublease was for a term of 12 months commencing January 1,
2006. This sublease has been extended through June 30, 2008.
The following table reflects our contractual obligations as of December 31, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period
|
|
|
|
|
|
|
|
Less
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Than
|
|
|
|
|
|
|
|
|
|
|
More than
|
|
Contractual Obligation(1)
|
|
Total
|
|
|
1 Year
|
|
|
1-3 Years
|
|
|
3-5 Years
|
|
|
5 Years
|
|
Contract Manufacturing by Related Party (2)
|
|
$
|
9,900,000
|
|
|
$
|
6,600,000
|
|
|
$
|
3,300,000
|
|
|
$
|
|
|
|
$
|
|
|
Purchase Obligations
|
|
|
327,857
|
|
|
|
327,857
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Lease Obligations
|
|
|
18,600
|
|
|
|
18,600
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
10,246,457
|
|
|
$
|
6,946,457
|
|
|
$
|
3,300,000
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
|
We have also entered into other collaborative arrangements under which we may be
obligated to pay royalties or milestone payments if product development is successful. We
do not anticipate that the aggregate amount of any royalty or milestone obligations under
these arrangements will be material.
|
|
(2)
|
|
The agreement has an initial two year period and is subject to quarterly true-ups. We
may terminate this contract manufacturing agreement with 180 days notice and payment of all
reasonable wind-up costs and Cognate may terminate the contract in the event that the brain
cancer clinical trial fails to complete enrollment by July 1, 2009. However, if such
termination by the Company occurs at any time prior to the earlier of the submission of an
FDA biological license application/new drug application on our brain cancer clinical trial
or July 1, 2010 or, such termination by Cognate results from failure of the brain cancer
clinical trial to complete patient enrollment by July 1, 2009, we are obligated to make an
additional termination fee payment to Cognate equal to $2 million.
|
Recent Accounting Pronouncements
In September 2006, the Financial Accounting Standards Board, or FASB issued SFAS No. 157,
Fair
Value Measurements
(SFAS No. 157). SFAS No. 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 No. 157 is effective for financial statements issued for fiscal
years beginning after November 15, 2007, and interim periods within those fiscal years. The
adoption of this standard is not expected to have a significant impact on our consolidated
financial position or results of operations.
In February 2007, the FASB issued SFAS No. 159,
The Fair Value Option for Financial Assets and
Financial Liabilities
(SFAS No. 159). SFAS No. 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 No. 159 is effective for financial statements issued for fiscal
years beginning after November 15, 2007. We are currently evaluating the impact of adopting SFAS
No. 159 on our financial position.
In December 2007, the FASB issued SFAS No. 141(R),
Business Combinations a Replacement of
FASB Statement No. 141
(SFAS No. 141(R)). The statement is to be applied prospectively for fiscal
years beginning on or after December 15, 2008; therefore, it applies to future business
combinations. The statement requires more assets acquired and liabilities assumed in future
business combinations to be measured at fair value as of the acquisition date. In addition,
expenses incurred for all acquisition-related costs are to be expensed and liabilities related to
contingent consideration are to be remeasured to fair value each subsequent reporting period. We
will adopt SFAS No. 141(R) effective January 1, 2009. We are currently evaluating the impact this
statement may have on our consolidated financial position or results of operations.
30
In December 2007, the FASB issued SFAS No. 160,
Noncontrolling Interests in Consolidated
Financial Statements an amendment of ARB No. 51
(SFAS No. 160). The statement changes how
noncontrolling interests in subsidiaries are measured to initially be measured at fair value and
classified as a separate component of equity. SFAS No. 160 establishes a single method of
accounting for changes in a parents ownership interest in a subsidiary that do not result in
deconsolidation. No gains or losses will be recognized on partial disposals of a subsidiary where
control is retained. In addition, in partial acquisitions, where control is obtained, the acquiring
company will recognize and measure at fair value all of the assets and liabilities, including
goodwill, as if the entire target company had been acquired. The statement is to be applied
prospectively for fiscal years beginning on or after December 15, 2008. We will adopt the statement
on January 1, 2009. We are currently evaluating the impact this statement will have, if any, on
our consolidated financial position or results of operations.
In June 2007, the EITF issued EITF Issue No. 07-3,
Accounting for Nonrefundable Advance
Payments for Goods or Services to be Used in Future Research and Development Activities
(EITF
07-3), which is effective for fiscal years beginning after December 15, 2007. EITF 07-3 requires
that nonrefundable advance payments for future research and development activities be deferred and
capitalized. Such amounts will be recognized as an expense as the goods are delivered or the
related services are performed. We do not expect the adoption of EITF 07-3 to have a material
impact on our financial results.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Market Interest Rate 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. and U.K. 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. Due to the short-term nature of our cash, we believe that our exposure to market interest
rate fluctuations is minimal. A hypothetical 10% change in short-term interest rates from those in
effect at December 31, 2007 would not have a significant impact on our financial position or our
expected results of operations. 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. As of
December 31, 2007, we do not have any borrowings outstanding. We do not have any foreign currency
or other derivative financial instruments.
Foreign Currency Exchange Rate Risk
As a corporation with contractual arrangements overseas, we are exposed to changes in foreign
exchange rates. These exposures may change over time and could have a material adverse impact on
our financial results. At this time we do not have a program to hedge this exposure as we do not
anticipate any material effect on our financial position given the current level of payments in
foreign currencies.
BUSINESS
Overview
Northwest Biotherapeutics, Inc. was formed in 1996 and incorporated in Delaware in July 1998.
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. Currently approved cancer treatments are frequently ineffective, can
cause undesirable side effects and provide marginal clinical benefits. Our approach in developing
cancer therapies utilizes our expertise in the biology of DCs, which are a type of white blood
cells that activate the immune system. Our primary activities since incorporation have been focused
on advancing a proprietary DC immunotherapy for prostate and brain cancer together with strategic
and financial planning, and raising capital to fund our operations.
We have two basic technology platforms applicable to cancer therapeutics: DC-based cancer
vaccines, which we call DCVax®, and monoclonal antibodies for cancer therapeutics. DCVax
® is our registered trademark. Our DCVax® DC-based cancer vaccine program is our main technology platform.
31
We completed an initial public offering of our common stock on NASDAQ in December 2001 and an
initial public offering of our common stock on the AIM of the London Stock Exchange in June 2007.
As described in further detail elsewhere in this prospectus, since 2004 we have undergone a
significant recapitalization pursuant to which (i) Toucan Capital loaned us an aggregate of $6.75
million, which notes payable and accrued interest thereon were converted into shares of our Series
A-1 Preferred Stock in April 2006 and subsequently converted into common stock in June 2007; and
(ii) Toucan Partners loaned us an aggregate of $4.825 million (excluding $225,000 in proceeds from
a demand note that was received on June 13, 2007 and repaid on June 27, 2007), which borrowings
have, in a series of transactions, been converted into convertible notes with an aggregate
outstanding principal of $4.825 million and related warrant coverage. In the fourth quarter of
2007, we repaid all of the remaining outstanding principal and accrued interest pursuant to these
convertible notes in the aggregate amount of $5.3 million to Toucan Partners.
In addition, on January 26, 2005, Toucan Capital purchased 32.5 million shares of our Series A
Preferred Stock at a purchase price of $0.04 per share, for a net purchase price of $1.276 million,
net of offering related costs of approximately $24,000. In June 2007, this Series A Preferred Stock
was converted into common stock.
On March 30, 2006, we sold approximately 2.6 million shares of common stock at a purchase
price of $2.10 per share and raised aggregate gross proceeds of approximately $5.5 million in a
closed equity financing with unrelated investors (the PIPE Financing). The total cost of the
offering recorded, including both cash and non-cash costs, was approximately $837,000.
On June 22, 2007, we placed 15,789,473 shares of our common stock with foreign institutional
investors at a price of £0.95 per share. The gross proceeds from the placement were approximately
£15.0 million, or $29.9 million, while net proceeds from the offering, after deducting commissions
and expenses, were approximately £13.0 million, or $25.9 million.
As of March 31, 2008, we had approximately $2.2 million of cash on hand. We will need to raise
additional capital in the near future to fund our clinical trials and other operating activities.
We are in the process of finalizing a debt financing of up to $8.0 million designed to cover our
operating cash requirements until the fourth quarter of this year. It is anticipated that up to
$4.0 million may be available to us by the end of April, and the balance may become available by
June. We are also negotiating additional financing with several other parties, which we hope to
complete later this year. There can be no assurance that we will be able to complete any of the
financings, or that the terms for such financings will be attractive. Our independent auditors have
indicated in their report on our December 31, 2007 financial statements that there is substantial
doubt about our ability to continue as a going concern. See Managements Discussion and Analysis
of Financial Condition and Results of Operations Liquidity and Capital Resources for additional
information regarding our liquidity, cash flow and financings.
Industry Background
Incidence of Cancer in the United States
The American Cancer Society estimates that in the U.S., men have a one in two lifetime risk of
developing cancer, while women have a one in three lifetime risk of developing cancer. Doctors are
expected to diagnose approximately 1.44 million new cases of cancer in the U.S. during 2008. It is
the second leading cause of death in the U.S. after heart disease and is estimated to result in
approximately 565,650 deaths, or 1,550 per day, in 2008. The direct medical costs related to
treating cancer in the U.S. were estimated to be $89.0 billion in 2007. The Companys initial
therapeutic targets, brain and prostate cancers, cause approximately 7.1 percent of cancer deaths
in the U.S. each year. The American Cancer Society has estimated that the incidence of new
diagnosis and deaths resulting from several common cancers during 2008 will be as follows:
32
|
|
|
|
|
|
|
|
|
Type of Cancer
|
|
New Cases
|
|
Deaths
|
Breast
|
|
|
184,450
|
|
|
|
40,930
|
|
Prostate
|
|
|
186,320
|
|
|
|
28,660
|
|
Colorectal
|
|
|
148,810
|
|
|
|
49,960
|
|
Lung
|
|
|
215,020
|
|
|
|
161,840
|
|
Liver
|
|
|
21,370
|
|
|
|
18,410
|
|
Melanoma
|
|
|
62,480
|
|
|
|
8,420
|
|
Brain
|
|
|
21,810
|
|
|
|
13,070
|
|
Ovarian
|
|
|
21,650
|
|
|
|
15,520
|
|
Incidence of Cancer in Europe
Globocan (Globocan 2002 is a database of cancer prevalence as collected by the Descriptive
Epidemology Group of the International Agency for Research on Cancer) estimates that the incidence
of new diagnosis and deaths resulting from several cancers during 2002 (the last year for which
estimates are available) would be as follows:
|
|
|
|
|
|
|
|
|
Type of Cancer
|
|
Estimated New Cases in 2002
|
|
|
Estimated Deaths in 2002
|
|
Breast
|
|
|
360,749
|
|
|
|
129,013
|
|
Prostate
|
|
|
230,627
|
|
|
|
83,066
|
|
Colorectal
|
|
|
371,706
|
|
|
|
203,296
|
|
Lung
|
|
|
374,764
|
|
|
|
341,595
|
|
Liver
|
|
|
53,618
|
|
|
|
57,486
|
|
Melanoma
|
|
|
62,367
|
|
|
|
16,633
|
|
Brain
|
|
|
48,385
|
|
|
|
39,061
|
|
Cancer
Cancer is characterized by aberrant cells that multiply uncontrollably. As cancer progresses,
the cancer cells may invade other tissues throughout the body producing additional cancers, called
metastases. Cancer growth can cause tissue damage, organ failure and, ultimately, death. Many
immunologists believe that cancer cells occur frequently in the human body, yet are effectively
controlled by the immune system because these cells are recognized as aberrant. Cancer growth
occurs if this natural process fails.
Cancer cells produce abnormal kinds and amounts of substances called antigens, which may be
distinguishable from those produced by healthy cells. The use of these cancer-associated antigens
is essential to the successful development of products capable of stimulating the immune system to
seek and destroy cancer cells marked by these antigens.
The Human Immune System
The immune system is the bodys defense mechanism responsible for recognizing and eliminating
cancer cells, viruses, bacteria and other disease-causing organisms. This system consists of
populations of white blood cells whose components are responsible for initiating the cellular
immune response, and the humoral, or antibody-based, immune response.
DCs, a component of white blood cells, initiate the cellular immune response by processing and
displaying disease-associated antigen fragments on their outer cell surface, where they are
recognized by white blood cells, known as naive T-cells, that have not yet been exposed to
antigens. Upon exposure to these antigen fragments, naive T-cells become disease-specific Helper
T-cells or Killer T-cells. Helper T-cells then induce Killer T-cells to locate and potentially
destroy the cells marked by the disease- associated antigen.
33
B-cells direct the immune response by binding to disease-associated antigens on the surface of
various cell types, producing disease-specific antibodies. Helper T-cells also enhance B-cell
production of disease- specific antibodies. These antibodies bind to and initiate the destruction
of cells marked by the associated disease-specific antigens.
A small population of activated Helper T-cells, Killer T-cells, and antibody-producing B-cells
survive for long periods of time, retaining the memory of what the disease fragment looks like.
These cells can respond very rapidly to subsequent exposure to disease-specific antigens and
fragments. The most effective natural immune response is one in which both Killer T-cells and
antibody-producing B-cells are activated.
The immune system response to cancer can be generally characterized by the following sequence:
|
|
Step 1.
DCs ingest cancer antigens, break them into small fragments and display them on their
outer cell surfaces.
|
|
|
Step 2.
DCs bearing these cancer antigen fragments bind to and activate naive T-cells, which
become disease-specific Helper T-cells and Killer T-cells.
|
|
|
Step 3.
The activated Helper T-cells produce factors that greatly enhance the cell division
of Killer T-cells and mature their cancer-killing properties.
|
|
|
Step 4.
Cancer cells and their cancer-associated antigens are also recognized by
antibody-producing B-cells.
|
|
|
Step 5.
The activated Helper T-cells produce factors that greatly enhance antibody production
by B-cells that in turn are specific for the cancer-associated antigens.
|
|
|
Step 6.
The Killer T-cells and antibodies, acting alone or in combination, destroy cancer
cells.
|
Limitations of Current Cancer Therapies
Traditional treatments for cancer include:
|
|
Surgery.
Surgery may be used to remove cancer cells, but not all cancer cells can be removed
surgically. Surgery may also result in significant adverse side effects such as collateral
damage to healthy tissue, bleeding and infection.
|
|
|
Radiation Therapy.
Radiation therapy may be used to treat cancers, but it can cause
significant damage to healthy tissue surrounding the targeted cancer cells. Recurrent cancers
may not be treatable with further radiation therapy. Radiation therapy may also cause
additional significant adverse side effects such as burns to treated skin, organ damage and
hair loss.
|
|
|
Chemotherapy.
Chemotherapy may be used to treat cancer, but involves the use of toxic
chemical agents. These toxic chemical agents affect both healthy and diseased cells and may
cause additional significant adverse side effects such as hair loss, immune suppression,
nausea and diarrhea.
|
|
|
Hormone Therapy.
Hormone therapy may be used to treat cancer, but involves the use of
substances that chemically inhibit the production of growth and reproductive hormones and is
also limited in effectiveness. Hormone therapy may cause significant adverse side effects such
as bone loss, hot flashes, impotence and blood clots.
|
Current Cancer Immunotherapy Approaches
Immunotherapy offers a new approach to be used as an adjuvant in combination with traditional
therapies. It can stimulate and enhance the bodys natural mechanism for destroying pathogens, such
as cancer cells, and may overcome many of the limitations of traditional cancer therapies. In
recent years, two cancer immunotherapy approaches have emerged to address the limitations of
traditional therapies, which have resulted in a number of products approved by the FDA:
34
|
|
Antibody-Based Therapies.
Currently approved antibody-based cancer therapies have modestly
improved survival rates with partially reduced side effects when compared with traditional
therapies. However, these antibody-based therapies can elicit an immune response against
themselves because they often contain mouse proteins or fragments of such proteins. This can
limit their effectiveness and potentially cause toxic side effects.
|
|
|
Immune-Modulating Agents.
Currently approved immune-modulating agents, such as IL-2 and
alpha-interferon, are known to have some ability to enhance the immune system and limited
efficacy to control cancer growth. However, these therapies involve delivery of the immune
modulating agent through the blood system and therefore cannot be directed exclusively to
cancer cells. This lack of selectivity may result in significant toxicity to healthy tissue.
|
Our Approaches
We have developed two proprietary approaches, DCVax® and therapeutic antibodies, for stimulating
and enhancing a patients natural cellular and humoral or antibody immune response to cancer. Given
appropriate funding for future development, we believe that DCVax® and CXCR4 antibody products may
overcome certain limitations of current cancer therapies and offer cancer patients safe and
effective treatment alternatives, alone or in combination with other therapies. Based on these
technology platforms, we have developed the following product pipeline:
The DCVax® Technology
DCVax® is a platform technology which we believe is applicable to most cancers. It combines a
patients own DCs with a patients own cancer-related biomarkers, or off-the-shelf antigens, to
induce immune responses against a patients cancer cells. The Companys early-stage clinical trial
data, and those of its collaborators, suggest that DCVax®-Brain and DCVax®-Prostate may have the
ability to significantly delay disease progression and significantly prolong patient survival,
while maintaining a superior quality of life when compared with current therapies.
The natural immune response starts with activation of a single master immune cell type, the
DC. This cell directs all ensuing activities of all components of the immune response. When a
virus, bacteria, or a cancer cell, encounters a DC, the DC consumes the virus, bacteria or cancer
cell and chops it into small pieces. In the process, the DC becomes activated and starts travelling
to the lymph node. In the lymph node, the DC elicits a cascade of events, that leads to an immune
response. Importantly, the nature of the virus, bacteria or cancer cell and the nature of the DC
activation dictate the type of immune response. Preparing the DC outside the body, as is done for
DCVax® products, is intended to allow the greatest degree of control and to begin the immune
response in the natural fashion leading to an enhanced response against the virus, bacteria or
cancer cell.
In cancer patients, the signaling through which the master immune cells are activated is
impaired. Our technology, therefore, involves delivering the necessary signals to activate the
master immune cells outside the patients body. We believe that after
35
receiving these signals, the master immune cells will be able to function normally and
mobilize the full immune response in the natural manner.
Different Approaches
Most traditional immunization approaches, including traditional virus, specific antigen or
peptide vaccines, as well as some that are used for immunotherapy of cancer, rely upon signaling
inside the patients body to try to activate and mobilize the already existing DC in the body, or
try to modulate only one arm of the immune system. These approaches have worked well to address
infectious diseases, but have generally failed to work in cancer patients because such approaches
are reliant upon signaling in the patients bodies which, as discussed above, is impaired in cancer
patients.
In addition, the immunogen, i.e. the virus, specific antigen, peptide or the cancer cells used
to prepare the vaccine, is in those cases injected into the body in a formulation that aims at
targeting and activating local DC. Examples are viral, specific antigen or peptide vaccines
formulated with adjuvant, or killed tumor cells alone or modified to produce the DC mobilizing
protein GM-CSF. In these instances, it is left to chance as to whether the immunogen arrives at the
DC, and whether the DC are properly activated and effectively migrate to lymph nodes to produce an
effective immune response.
Treatments that use only a single arm of the immune system may employ large amounts of
T-cells, or a single (monoclonal) antibody. We believe that the DCVax® products have a clear
advantage compared to this approach in that they are designed to activate all aspects of the immune
response, both cellular and antibody, thereby potentially providing a broader and longer lasting
immune and clinical response. Our DCVax® products consist of pure, activated DC loaded with the
immunogen as would naturally occur, and that are capable of migrating to lymph nodes. The intended
result is a full immune response consisting of both a specific cellular T-cell response and a
specific antibody response against the cancer-associated antigen consistent with our Phase I and
Phase II clinical trial results for DCVax®-Brain and DCVax®-Prostate, respectively, and that is
translated into a potential clinical benefit in this case, a delay in disease recurrence and an
extension of overall survival of the patient.
Cancer and the Immune System
Cancer cells produce many substances that shut down the immune response, as well as substances
that suppress or block the DC that are resident in the body. The optimal time for controlling
cancer growth by activating the immune system is, therefore, at the time when tumor burden is low.
Our DCVax® products target patients with brain cancer following surgery, radiation and
chemotherapy, and hormone independent prostate cancer patients with no detectable tumor. This
approach is designed to allow induction of powerful
immune responses to control progression of the disease. However, in clinical trials, delays in
cancer progression and extension of survival have also been seen in late stage patients treated
with DCVax®-Brain and DCVax®-Prostate.
36
The DCVax® Process
The DCVax
® platform uses our proprietary process to efficiently produce and activate DCs outside a
patients body. The clinical trials with DCVax®-Brain and DCVax®-Prostate suggest that these cells
can generate an effective immune system response when administered therapeutically. Manufacture of
a DCVax® product takes approximately 30 days to complete for DCVax®-Prostate and approximately 10
days for DCVax®-Brain, and is characterized by the following sequence:
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Collection.
A sample of a patients white blood cells is collected in a single and simple
outpatient procedure called leukapheresis.
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Isolation of Precursors.
These cells are sent to a manufacturing facility, where DC
precursors are isolated from the patients white blood cells.
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Differentiation by Growth Factors.
DC precursors are transformed in a manner that mimics the
natural process in a healthy persons body, through the application of specific growth
factors, into highly pure populations of immature DCs during a six-day culture period.
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Maturation.
Immature DCs are exposed to a proprietary maturation factor or maturation method
in order to maximize Helper T-cell, Killer T-cell, and B-cell activation.
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Antigen Display.
Cancer-associated antigens, fragments of cancer-associated antigens or
deactivated whole cancer cells are added to, ingested, and processed by the maturing DCs,
causing the DCs to display fragments of cancer-associated antigens on their outer cell
surfaces.
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Harvest.
These DCs are harvested and separated into standardized single-use DCVax
®
administration vials, frozen and stored.
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Quality Control.
DCVax® product lot undergoes, according to current industry standards,
rigorous quality control testing, including sterility testing for bacterial and mycoplasma
contamination, and potency testing prior to shipment to the administration site for injection.
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DCVax®-Brain Manufacturing Steps:
37
DCVax® Characteristics
The DCVax® platform combines our expertise in DC biology, immunology and antigen discovery
with our proprietary process of activating DCs outside a patients body to develop therapeutic
products intended to stimulate beneficial immune responses to treat cancer in a cost-effective
manner. DCVax® has the following significant characteristics, the combination of which we believe
makes it a highly attractive alternative to current therapies.
Activation of the Natural Immune System
Our DCVax® product candidates are designed to elicit a natural immune response. Pre-clinical and
clinical trials suggest that our DCVax® product candidates can train a patients own Killer T-cells
to locate and destroy specifically targeted cancer cells. These same clinical trials also suggest
that DCVax®-Prostate stimulates the body to produce antibodies and/or Killer T-cells that bind to
cancer-associated antigens and potentially destroy cancer cells marked by these antigens. Moreover,
the clinical trials show that this immune response may be effective in delaying time to disease
progression in brain and prostate cancer, and both may prolong survival and improve the quality of
life for brain and prostate cancer patients.
Intended Impact of One Educated Dendritic Cell on Anti-Cancer Cells
Multiple Cancer Targets
We believe that our DCVax® platform can be applied towards the treatment of a wide variety of
cancers. The platform affords the flexibility to target many different forms of cancer through the
pairing of DCs with cancer-associated antigens, fragments of cancer-associated antigens or
deactivated whole cancer cells as well as possible direct intra-tumoral injection of partially
mature DCs.
38
Targeting of Serious Cancers with No Effective Treatments
DCVax®-Prostate targets men with rising PSA levels while on hormone therapy, but before
metastases develop. There is currently no effective treatment for this growing population of
patients who invariably go on to develop complications from the spread of their cancer to the bone
and, eventually, succumb to their disease. DCVax®-Brain targets patients with GBM, a highly lethal
form of brain
cancer. In two Phase I trials carried out at UCLA from 1999 to the present day, patients
treated with DCVax®-Brain have survived more than twice as long without relapse compared to matched
concurrent controls not receiving DCVax®-Brain (under matched concurrent controls patients
received standard of care treatment at the same time clinical trial patients were treated with
standard of care treatment together with DCVax®-Brain; these control patients have been matched for
the major prognostic factors for GBM).
Low Incidence of Significant Adverse Side Effects or Toxicity
Our initial two DCVax
®-Brain Phase I trials, and DCVax®-Prostate Phase I/II clinical trial
have shown no significant adverse side effects in over 250 administered injections. Some patients
had moderate injection site reactions, and we observed some severe injection site reactions that we
believe to be a result of immune activation. Patients treated with DCVax®-Brain or DCVax
®-Prostate
therefore might not need to take additional prescription drugs to manage undesirable side effects
as is often the case with certain current cancer treatments. We minimize the potential for toxicity
by using the patients own cells to create its DCVax® product candidates. Additionally, because our
DCVax® products are designed to target the cancer- associated antigens in the patient, collateral
damage to healthy cells is minimized.
Efficient and Cost-Effective Manufacturing
We have developed a second generation closed and automated device based on tangential flow
filtration (TFF-Cell Separation System) for manufacturing DC from patient leukapheresis material.
We have a contract with Cognate for the manufacture of DCVax®-Brain product for clinical use. This
TFF-Cell Separation System is currently undergoing validation. See - Manufacturing.
Ease of Administration
We initially collect a sample of a patients white blood cells in a single standard outpatient
procedure called leukapheresis. After patient-specific manufacturing and quality control testing,
each small dose of a DCVax® product candidate is administered by a simple intradermal injection in
an outpatient setting. Dendritic cells administered by intradermal injection migrate to the
draining lymph nodes where they interact with and activate T-cells.
Complementary with Other Treatments
Our DCVax® product candidates are designed to stimulate the patients own immune system to
safely target cancer cells. Consequently, we believe these products may be used as an adjuvant to
standard therapies such as chemotherapy, radiation therapy, hormone therapy and surgery.
39
Our Clinical and Pre-clinical Development Programs
The following table summarizes the targeted indications and status of our product candidates:
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Product Candidate
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Target Indications
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Status
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DCVax® Platform
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DCVax®-Prostate
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Prostate cancer
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Phase III clinical trial cleared by the
FDA for recruitment of patients for
non-metastatic hormone independent prostate
cancer
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DCVax®-Brain
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Glioblastoma multiforme
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Phase II clinical trial initiated.
Orphan Drug designation granted in the U.S.
in 2006 and in the E.U. in 2007
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DCVax®-LB
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Non-small cell lung cancer
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Phase I clinical trial cleared by the FDA
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DCVax®-Direct
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Solid tumors
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Phase I clinical trial cleared by the
FDA for ovarian cancer, head and neck
cancer and two other indications (expected
to be liver and pancreatic cancers)
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DCVax®-L
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Resectable Solid Tumors
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Phase I/II clinical trial currently
underway at the University of Pennsylvania
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Pre-clinical means that a product candidate is undergoing efficacy and safety evaluation in disease
models in preparation for human clinical trials. Phase I-III clinical trials denote safety and
efficacy tests in humans as follows:
Phase I: Evaluation of safety and dosing.
Phase II: Evaluation of safety and efficacy.
Phase III: Larger scale evaluation of safety and efficacy.
40
DCVax ®Product Candidates
DCVax®-Brain
DCVax®-Brain uses our DCVax® platform in combination with the patients own glioblastoma tumor
cell lysate antigens. Our clinical collaborators at UCLA conducted two Phase I clinical trials to
assess the safety and efficacy of DC-based immunotherapy for GBM. In the first Phase I clinical
trial, DCVax®-Brain was administered to 12 patients and in the second Phase I clinical trial it was
administered to 17 patients. The patients in both trials were treated with DCVax®-Brain being
administered as an adjuvant to standard of care.
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Progression Free Survival
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Overall
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Solid lines: patients treated with DCVax-Brain; dashed lines: institutional controls
The data from progression and survival Kaplan Meier curves of both of these trials together
(see figure above) show that newly diagnosed GBM patients treated at UCLA, and matched for the
major prognostic factors, with DCVax®-Brain had a delay in the median time to recurrence or
progression of disease from 8.1 months with standard of care treatments in matched concurrent
control patients to 18.1 months in patients treated with DCVax®-Brain (p = 0.00001). DCVax®-Brain
increased median overall survival from 17.0 months with standard of care in matched concurrent
control patients treatments to 33.8 months in patients treated (and continuing as the median is not
yet reached) for DCVax®-Brain treated patients, again matched for the major prognostic factors (p
< 0.0015). The p value measures the likelihood that the difference between the treated and
non-treated patients is due to chance. A `p value less than or equal to 0.05 (meaning there is a 5
percent or lower possibility that the observed clinical effect is due to chance) is required for
product approval by the FDA and European regulatory authorities. The p value of 0.0015 observed
with DCVax®-Brain means that there is only a 0.15 percent possibility that the observed effect
between standard of care and DCVax®-treated patients is due to chance. Eight of the 19 patients
remained alive for periods ranging, to date, from 24.5 to 92 months, with five patients having
lived for over 45 months without cancer recurrence. Similarly, in recurrent (late stage) patients,
DCVax®-Brain has increased median survival from 6.4 months for those receiving standard of care to
12.2 months for patients receiving DCVax®-Brain.
41
In December 2006, we commenced recruiting patients with newly diagnosed GBM in a 141 patient
Phase II DCVax®-Brain clinical trial. We planned to carry out the study at 12 to 15 clinical
sites. The study was designed as a randomized study in which patients received either DCVax®-Brain
in addition to standard of care or standard of care alone. To date, almost 50 patients have been
screened at 4 clinical sites. However, patients have been reluctant to enroll in the study when
faced with a 33% chance of being randomized into the control arm of the study under which they will receive standard of care
alone. To date three patients have been enrolled. In order to address this issue we redesigned
the study as a randomized, placebo controlled, double blinded study with a cross-over arm allowing
control patients to be treated with DCVax®-Brain in the event that their cancer progresses. The
study size has been increased from 141 to 240 patients and is designed to enable us to petition the
FDA for accelerated approval if the study generates results similar to those achieved in earlier
Phase I studies. In order to enable rapid enrollment, we are in the process of enrolling 45 to 50
additional clinical sites for this trial. As of April 9, 2008, seven sites are active and a
further 31 sites are at various stages of the start-up process. We are engaged in discussions with
the FDA concerning the study design and end points. Depending on trial results, we plan to seek
product approval in both the U.S. and the E.U.
In February 2007, we, through our legal representative, applied to the Bundesamt für
Gesundheit (BAG or Office Fédéral de la Santé Publique) in Switzerland for an Authorization for
Use (Autorisation). In June 2007, we, through our legal representative, received such
Autorisation from the BAG to make DCVax®-Brain available at limited selected medical centers in
Switzerland, as well as an authorization (Autorisation pour activités transfrontalières avec des
transplants) to export patients cells and tissues from Switzerland, for vaccine manufacturing in
the United States, and to import patients DCVax®-Brain finished vaccines into Switzerland. These
authorizations are conditional upon certain implementation commitments which must be fulfilled to
the satisfaction of Swissmedic (Institut Suisse des Agents Thérapeutiques) before the product may
be made available (e.g., finalizing our arrangements for a clean-room suite for processing of
patients immune cells). We believe we have fulfilled these commitments and are awaiting Swissmedic
confirmation.
In the BAGs processing of and decision on our application and data with respect to the
authorizations described above, Swissmedic conducted an inspection of our facilities. A
comprehensive evaluation of DCVax®-Brain will be conducted by Swissmedic during its processing of
our Marketing Authorization Application (MAA) which we filed with Swissmedic in December 2007.
The assessment by Swissmedic of our MAA will include a full review by Swissmedic of the safety and
efficacy data generated in our DCVax®-Brain clinical studies to date. This review could take up to
one year from December 28, 2007, the date on which the MAA was submitted. Until such a Market
Authorization is granted, and assuming we complete our implementation commitments to the
satisfaction of Swissmedic, DCVax®-Brain may only be made available at the selected Medical Centers
in Switzerland under the Autorisation granted by the BAG. The term of the BAG Autorisation is five
years from June 2007.
Standard of Care:
The current standard of care for GBM was established in a 573 patient study as
set out by Stupp
et al
. in
N Engl J Med 352;10,
and resulted in a median time to progression of 6.9
months and a median overall survival rate of 14.6 months in patients receiving a standard of care
treatment regimen. The standard of care established in the Stupp trial for GBM patients consists of
surgery followed two weeks later by radiation therapy with concomitant Temodar chemotherapy,
followed by six monthly cycles of Temodar chemotherapy. The DCVax®-Brain treatment regimen fits
between the steps of this current standard of care, and does not require a change in clinical
practices, other than one 30-day delay after the first chemotherapy treatment.
Target Market:
The American Cancer Society estimates that about 21,810 new cases of brain cancer
will be diagnosed in the U.S. during 2008. Deaths from newly diagnosed malignant primary brain
cancer in the U.S. are estimated to be approximately 13,070 per year. Globocan has estimated that
about 48,385 new cases of brain cancer would be diagnosed in Europe in 2002 (the last year for
which estimates are available). Deaths from brain cancer in Europe were estimated at 39,061 in
2002.
Current Treatments:
Existing treatments for GBM include surgery, radiation and chemotherapy. Such
treatments are often used in various combinations and/or sequences and have significant adverse
side effects such as bleeding, seizures, nausea and collateral tissue damage. Following initial
treatment, virtually all cases of this cancer recur, with a life expectancy of approximately six
months following recurrence. Few, if any, effective therapies exist for these patients. We believe
that DCVax®-Brain has the potential to address this critical unmet medical need.
Cost Recovery:
We submitted an application to the FDA for cost recovery for our Phase II trial
in brain cancer. Approval of this application would permit us to charge patients or their insurers
for the direct costs of manufacturing DCVax®-Brain during this clinical trial. However
because we have changed the study design to include a placebo control arm we have no ability to
charge patients for DCVax®-Brain without unblinding the study and as a result we have
ceased pursuing the application.
42
DCVax®-Prostate
DCVax®-Prostate targets hormone independent (i.e. late stage) prostate cancer. DCVax®-Prostate
combines our DCVax® platform with the cancer-associated antigen prostate specific membrane
antigen or PSMA. PSMA is located on the surface of prostate cells. It is expressed at very low
levels on benign or healthy prostate cells, and at much higher levels on prostate cancer cells.
Because PSMA is over-expressed in virtually all prostate cancers, it represents an effective target
for prostate cancer therapeutics. In addition, since PSMA is over-expressed in virtually all
prostate cancer tissues, we do not have to screen patients. DCVax®-Prostate is designed to be used
in the whole patient population. In contrast, the use of other cancer vaccines in development may
be limited to part of the patient population and require screening of patients.
In September 1999, we filed an application to conduct a Phase I/II clinical trial for
DCVax®-Prostate to treat late-stage prostate cancer patients for whom hormone therapy was no longer
effective. This trial, which was carried out at the M.D. Anderson Cancer Centre and at UCLA,
involved the administration of DCVax®-Prostate to 33 evaluable patients in order to establish the
safety of three different dosage levels of DCVax®-Prostate.
Additional data from our Phase I/II DCVax®-Prostate clinical trial in 33 patients with
non-metastatic and metastatic hormone independent prostate cancer indicates the following. Of a
total of 33 patients who have been treated in this trial, 11 were non-metastatic hormone
independent prostate cancer patients (group A) and 22 were metastatic hormone independent prostate
cancer patients (group B). In group A, there has been an increase in survival from 36 months for
the natural course of the disease to >54 months for DCVax®-Prostate treated patients. The median
had not yet been reached as of the end of 2005 (the latest date to which long-term data is so far
available). In this group the time to metastases under the natural course of the disease is 28 to
36 weeks. This time was lengthened to 59 weeks in patients who received DCVax®-Prostate. In group
A, none of the 11 patients had progressed at 28 weeks and only five had progressed at 59 weeks. The
group A patient population is the patient population that we will focus on in our Phase III
clinical trial.
In group B (hormone independent patients with metastases), there was an increase in median
overall survival from 18.9 months for standard of care to 38.7 months for DCVax®-Prostate treated
patients. Patients in this study had a six-times greater chance of being alive at 36 months
compared to patients treated with the standard of care.
Many cancer therapeutics elicit a clinical response in only a small fraction of patients. In
clinical trials, DCVax®-Prostate has been shown to elicit a specific PSMA antibody response and a
specific and strong T-cell response in about 80 percent of patients. We believe that the
administration of DCVax®-Prostate may enhance progression free survival relative to placebo, delay
the development of symptomatic disease and increase overall survival.
DCVax®-Prostate has been cleared by the FDA for a Phase III clinical trial in about 600
patients in 50 centers. The patient population is non-metastatic hormone independent prostate
cancer. We currently intend to separate the 600 patient Phase III trial into two single Phase III
clinical trials in non- metastatic hormone independent prostate cancer patients with about 300
patients per trial.
Standard of Care.
The standard of care for metastatic hormone independent prostate cancer was
established in a 674 patient study as set out by Petrylak et al. in
N Engl J Med 351;15
and
resulted in a median overall survival rate of 18.9 months. This standard of care consists of
Taxotere (chemotherapy) being administered as a single dose every three weeks or in a weekly
regime. Other drugs, such as mitoxantrone and prednisone, are also administered to patients for
pain derived from bone metastasis. The DCVax®-Prostate treatment regimen fits between the steps of
current standard of care, and does not require a change in clinical practices. There is no
established standard of care for non-metastatic hormone independent prostate cancer as there is no
FDA approved therapeutic product for this type of prostate cancer.
Target Market.
The American Cancer Society estimates that 186,320 new cases of prostate cancer will
be diagnosed in the U.S. during 2008. Deaths from prostate cancer in the U.S. are estimated to be
28,660 for 2008. We estimate that there is an initial DCVax®-Prostate target population in the U.S.
consisting of approximately 100,000 patients per year with non-metastatic hormone independent
prostate cancer. Globocan has estimated that 230,627 new cases of prostate cancer would be
diagnosed in Europe in 2002 (the last year for which estimates are available). Deaths from prostate
cancer in Europe were estimated at 83,066 in 2002.
43
Current Treatments.
Existing treatments for localized (i.e. newly-diagnosed) prostate cancer
include surgery and/or various forms of radiation therapy. The current standard of care for
treating patients who fail primary therapy is hormone therapy through which the effect of male
hormones is blocked. Although this therapy achieves temporary tumor control, prostate cancer
patients eventually fail hormone treatments, meaning that blocking of hormones no longer keeps the
cancer under control. The United States National Cancer Institutes 1989-1996 five-year survival
rate for metastatic prostate cancer is only 32 percent. Moreover, hormone therapy may cause
significant adverse side effects, including bone loss, hot flushes and impotence. Disease
progression despite hormone therapy occurs on average in two years, and is then classified as
hormone independent prostate cancer. Approximately 55 percent of patients with hormone independent
prostate cancer will die within two years of its onset. Currently, the only FDA approved treatments
for hormone independent prostate cancer are chemotherapy and radioactive pharmaceuticals, which can
alleviate cancer-related symptoms but may cause significant toxic side effects and only prolong
survival by approximately two and a half months. A large proportion of hormone independent patients
do not have objective metastatic disease as measured by bone and CT scans. We believe that
DCVax®-Prostate has the potential to address this critical unmet medical need.
DCVax®-LB
DCVax®-LB is targeting non-small cell lung cancer, the largest cause of cancer deaths in both
the U.S. and Europe. DCVax®-LB combines our DCVax® platform with isolated and killed lung cancer
cells as antigens. The autologous DCs used to formulate DCVax®-LB are activated through a process
similar to that used in the manufacturing of DCVax®-Prostate. We had an investigational new drug
application (IND) cleared by the FDA in May 2006 for a Phase I clinical trial using DCVax®-LB in
non-small cell lung cancer.
Target Market.
The American Cancer Society estimates that 215,020 new cases of lung cancer will be
diagnosed in the U.S. during 2008. Approximately 80 percent of these cases are expected to be
attributable to non-small cell lung cancer, the indication that we are targeting. Deaths from all
forms of lung cancer are estimated to be 161,840 for 2008. Globocan has estimated that 374,764 new
cases of lung cancer would be diagnosed in Europe in 2002 (the last year for which estimates are
available). Deaths from lung cancer in Europe were estimated at 341,595 in 2002.
Current Treatments.
Existing treatments for non-small cell lung cancer include surgery and
radiation therapy, which are used in various combinations. These treatments have significant toxic
side effects and have limited clinical benefit. The American Cancer Society has reported that only
16 percent of patients diagnosed with non-small cell lung cancer survive after five years.
Following initial treatment, virtually all cases of this cancer recur, with a life expectancy of
approximately one year following recurrence.
DCVax®-L
DCVax®-L targets any kind of solid tumor cancer and it combines our DCVax® platform with
patient specific tumor lysate. Following surgery, the tumor is prepared as a lysate (i.e. the tumor
tissue is finely chopped) for loading into autologous DCs. The patients tumor lysate contains
cancer specific biomarkers which will be added to the patients own DCs and subsequently injected
back into the patient to elicit a cancer specific immune response. We commenced a Phase I/II study
using DCVax®-L at the University of Pennsylvania in 2007.
Target Market:
The American Cancer Society estimates that 21,650 new cases of ovarian cancer
will be diagnosed in 2008 and that there will be approximately 15,520 deaths from the disease.
Globocan has estimated that 63,467 new cases of ovarian cancer were diagnosed in Europe in 2002
(the last year for which estimates are available). Once ovarian cancer has recurred, there are
currently no effective treatments for the disease. Thus, new treatment modalities that prevent or
delay cancer recurrence are of importance in prolonging survival in women with ovarian cancer.
This study is being funded by the Ovarian Cancer Vaccine Initiative (OCVI), a private philanthropic
organization.
Current Treatments:
Standard therapy includes surgical debulking, followed by chemotherapy with a
taxane/platinum combination for six to eight cycles. Of the patients who present with advanced
stage disease (III or IV), 70 percent will have an initial clinical remission following surgery and
chemotherapy, with no evidence of disease by physical examination, radiographic imaging (such as CT
or MRI) or normalization of the CA125 tumor marker. However, for most of these patients, the
ovarian cancer will recur within two years. The median time to progression is approximately 20
months even for patients who received total or near-total surgical removal of the initial tumor and is approximately 14 months for patients with less complete
surgical removal of the initial tumor. Once ovarian cancer has recurred, it is not considered
curable and progression to death is usually inevitable, despite aggressive chemotherapy strategies.
The overall five year survival for advanced ovarian cancer remains at only 20 to 30 percent.
44
DCVax®-Direct
DCVax®-Direct uses our DCVax® platform to activate DCs suitable for direct injection into
solid tumors. DCVax®-Direct is designed to treat cancer patients whose tumor tissue is not
available or whose tumors are considered to be inoperable. Several scientific studies have shown
that DCs injected into solid tumors in animal models can result in tumor regression. We have
demonstrated in pre-clinical animal studies the ability of activated DCs, when injected directly
into just a single tumor of mice bearing multiple tumors, to cause all tumors to regress. In these
studies, subsequent challenge of these now tumor-free mice with the injection of additional tumor
cells was met with total rejection of tumor growth demonstrating an immunization of the mouse
against regrowth of the tumor. The DCs used in the formulation of DCVax®-Direct are activated
through a process similar to that used for DCVax®-Brain and DCVax®-Prostate (i.e. using heat-killed
and formalin-fixed BCG mycobacteria and interferon gamma), although they are not loaded with tumor
antigens prior to injection. Rather, the antigen loading takes place
in vivo
after injection of the
DCVax®-Direct DCs into the tumor tissue, typically following radiation therapy, chemotherapy, or
other treatments that kill tumor cells.
We have a Phase I clinical trial protocol under the DCVax®-Direct IND for the treatment of
head and neck cancer. This clinical trial protocol was cleared by the FDA in the third quarter of
2006. We intend to identify the most appropriate cancers for the remaining two available trials
under the DCVax®-Direct IND at the appropriate time, although our present intention is to pursue
liver and pancreatic cancers.
Target markets
: The American Cancer Society estimates that 21,650 new cases of ovarian cancer and
35,310 new cases of head and neck cancer will be diagnosed in the U.S. during 2008. Globocan has
estimated that 63,467 new cases of ovarian cancer and 98,175 new cases of head and neck cancer were
diagnosed in Europe in 2002 (the last year for which estimates are available). Deaths from ovarian
cancer and head and neck cancer in Europe were estimated at 41,024 and 43,273 respectively. Deaths
from all solid tumors are estimated to be approximately 500,000 in 2008. Deaths from all solid
tumors are estimated at approximately 815,000 in the E.U. in 2002 (the last year for which
estimates are available).
Current treatments
: Current treatments for solid tumors typically involve cytotoxic therapy aimed
at killing tumor cells. Such treatments include radiation therapy, chemotherapy, or other cell
killing treatments such as cryotherapy. These treatments can still be used along with DCVax®-Direct
as they can potentially prepare the tumor tissue for the injection of DCVax®-Direct. The ability to
still use conventional cytotoxic agents along with DCVax®-Direct will enable DCVax®-Direct to be
adopted in the market without requiring any change of existing clinical practice if so desired.
Therapeutic Antibody Product Candidates
We have been issued patent coverage by the U.S. Patent and Trademark Office which gives us
broad rights to the use of CXCR4 antibodies to treat cancer. CXCR4 is a protein that plays a key
role in the progression of primary cancers and in the metastatic process. CXCR4 is over-expressed
in more than 75 percent of cancers including non-small cell lung cancer, breast cancer, GBM, colon
cancer, melanoma, prostate, pancreatic, kidney, ovarian, and certain blood cancers. In all of these
cancers CXCR4 is centrally involved in all three phases of disease progression: proliferation of
the primary tumor, migration of cancer cells out of the primary tumor, and establishment of distant
metastatic sites.
We have completed substantial research and pre-clinical testing phases with two versions of
CXCR4 antibodies. We intend to identify the most appropriate cancers for clinical trial or multiple
clinical trials using CXCR4 antibodies at the appropriate time.
Multiple Therapeutic Applications
Therapeutic antibodies may be used as stand-alone products that bind to cancer-associated
antigens and potentially destroy cancer cells marked by these antigens. Therapeutic antibodies may
also enable the targeted delivery of existing therapies such as radiation and cytotoxic agents. The
inherent toxic effects of cytotoxic agents and radioactive materials on normal tissue could be
minimized by coupling these agents to antibodies that have a high degree of specificity to cancer
cells.
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Manufacturing
We have developed a proprietary manufacturing system that enables us to produce vaccines for
an entire multi-year course of treatments in a single manufacturing run using the cancer patients
own DCs and the patients own tumor biomarkers. This manufacturing process results in sufficient
patient-specific DCVax® product for at least a course of 11 injections of DCVax®, which is
sufficient for three years of treatment. The product thus becomes like an off-the-shelf drug
after the initial manufacturing run. The advantages of this method compared to other cell vaccine
production, include not only the off-the-shelf feature of drug delivery to clinics and patients,
but also the significant reduction in product cost due to the fact that the product does not have
to be separately manufactured for each and every treatment injection.
We have entered into a services agreement with Cognate pursuant to which Cognate will provide
certain consulting and, when needed, manufacturing services, for our DCVax ®-Brain Phase II
clinical trial. In this process, DC precursor cells are isolated from the patients blood and
matured into new functional DCs. These DCs are combined with a patients own cancer biomarkers from
the patients tumor tissue removed in surgery. The finished vaccine is then frozen in single-dose
vials where they can remain for many years until required for treatment of the patient.
The current capacity of Cognates existing California cGMP (clean room manufacturing under
current Good Manufacturing Practices) facility is approximately 300 patients per year, which we
believe will be sufficient for our Phase II clinical trial for DCVax®-Brain. We have a plan with
Cognate to accommodate an increase in production capacity based on demand and have detailed plans
and cost analysis for four modular expansions which should increase the capacity of the current
facilities from approximately 300 patients to over 5,000 patients per year. We believe that
Cognates current facilities are sufficient to cover additional agreements for our initial
commercialization efforts in Switzerland, and potentially in the United States and/or Europe, as
well as to meet demands of clinical trial activity once commenced.
We intend to commence use of the TFF-Cell Separation System in an upcoming DCVax® Phase I
clinical trials which we plan to start in 2008. The TFF-Cell Separation System is also targeted to
be implemented into the DCVax®-Brain product after bioequivalence studies have been completed.
Since the product economics are favorable even with the existing first generation manufacturing
process, we intend to only implement the TFF-Cell Separation System at a time and in a manner that
does not interfere with the pivotal Phase II clinical trial for DCVax®-Brain, or product approval
or launch.
Marketing
In the event that we secure adequate funding and develop an approved product, we will then
determine whether to market and sell that product ourselves, or to partner with one or more
established pharmaceutical companies. If we chose to enter into marketing and sales agreements with
partners, our collaboration with these companies may take the form of royalty agreements, licensing
agreements or other co-marketing arrangements. However, there is a substantial likelihood that we
will choose to market and sell our products ourselves.
Intellectual Property
We protect our proprietary technologies through patents issued and licensed throughout the
world. We have 28 issued and licensed patents (9 in the U.S. and 19 in other jurisdictions) and 134
patent applications pending (17 in the U.S. and 117 in other jurisdictions) which cover the use of
DCs in DCVax® as well as targets for either our DC or monoclonal antibody therapy candidates and
isolation and manufacturing, handling and administration of DCVax®. The issued patents expire at
various dates between 2015 and 2026. We intend to continue using our scientific expertise to pursue
and patent new developments with respect to uses, methods, and compositions to enhance our position
in the field of cancer treatment.
We have received orphan designation in the U.S. and the E.U. for our DCVax®-Brain product
candidate applicable to gliomas, which comprise most primary brain cancers, including GBM. Orphan
designation in the U.S. entitles us to seven years of market exclusivity for the particular
indication and active ingredient provided that the product is the first such orphan to be approved
for that indication. Orphan designation in the E.U. entitles us to ten years of market exclusivity
on a similar basis.
46
Any patents that we obtain may be circumvented, challenged or invalidated by our competitors.
Our patent applications may not result in the issuance of any patents, and any patents that may be
issued may not offer any protection against others who seek to practice the claimed inventions. We
have obtained licenses for certain technologies that we use, but we may be unable to maintain those
licenses and may be unable to secure additional licenses in the future. Thus, we may be forced to
abandon certain product areas or develop alternative methods for operating in those areas.
In addition to patents, we rely on copyright protection, trade secrets, proprietary know-how
and trademarks to maintain our competitive position. Our future success will depend in part on our
ability to preserve our copyrights and trade secrets. Although our officers, employees,
consultants, contractors, manufacturers, outside scientific collaborators, sponsored researchers
and other advisors are required to sign agreements obligating them not to disclose our confidential
information, these parties may nevertheless disclose such information and compromise our
confidential data. We may not have adequate remedies for any such breach. It is also possible that
our trade secrets or proprietary know-how will otherwise become known or be independently
replicated or otherwise circumvented by competitors.
Our technologies may infringe the patents or violate other proprietary rights of third
parties. In the event of infringement or violation, we may be prevented from pursuing further
licensing, product development or commercialization. Such a result would materially adversely
affect our business, financial condition and results of operations.
If we become involved in any litigation, interference or other administrative proceedings, we
will incur substantial expenses and the efforts of our technical and management personnel will be
significantly diverted. An adverse determination may subject us to significant liabilities or
require us to seek licenses, which may not be available. We may also be restricted or prevented
from manufacturing and selling our products, if any, in the event of an adverse determination in a
judicial or administrative proceeding, or if we fail to obtain necessary licenses. In addition, any
potential litigation or dispute may, as a result of our lack of funding, require us to further
reduce or even curtail our operations entirely.
Competition
The biotechnology and biopharmaceutical industries are characterized by rapidly advancing
technologies and a strong emphasis on proprietary products. Several companies, such as Cell
Genesys, Inc., Dendreon Corporation, Immuno-Designed Molecules, Inc., Celldex Therapeutics, Inc.,
Ark Therapeutics plc, Oxford Biomedica plc, Argos Therapeutics, Inc. and Antigenics, are actively
involved in the research and development of immunotherapies or 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. These clinical trials target patients with prostate
cancer, although their patient populations are different from those targeted by our Phase III
DCVax®-Prostate product candidate. Celldex Therapeutics is commencing a Phase II clinical trial,
which could become a Phase II/III trial, with a peptide immunotherapy for newly diagnosed GBM. Ark
Therapeutics is in a Phase III trial with a gene therapy for operable high grade gliomas. The
clinical trial data reported to date by these companies for brain and prostate cancer have not
shown as long a delay in disease progression, or as long an extension of survival, as have our
clinical data to date. As far as we are aware, no cell-based therapeutic product for cancer is
currently available for commercial sale.
Additionally, several companies, such as Medarex, Inc., Amgen, Inc., Agensys, Inc., and
Genentech, Inc. are actively involved in 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 therapeutic products 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:
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biopharmaceutical companies;
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biotechnology companies;
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pharmaceutical companies;
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academic institutions; and
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other research organizations.
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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. In addition, many of these competitors have become
more 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 competitors may prevent us from recruiting and retaining qualified
scientific and management personnel, or from acquiring technologies complementary to our programs.
We expect that our ability to compete effectively will be dependent upon our ability to:
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secure the necessary funding to continue our development efforts with respect to our product
candidates;
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successfully complete clinical trials and obtain all requisite regulatory approvals;
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maintain a proprietary position in our technologies and products;
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attract and retain key personnel; and
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maintain existing or enter into new partnerships.
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Governmental Regulation
Governmental authorities in the United States and other countries extensively regulate the
pre-clinical and clinical testing, manufacturing, labeling, storage, record-keeping, advertising,
promotion, export, marketing and distribution, among other things, of immunotherapeutics. In the
United States, the FDA subjects pharmaceutical and biologic products to rigorous review. Even if we
ultimately receive FDA approval for one or more of our products, if we or our partners do not
comply with applicable requirements, we may be fined, our products may be recalled or seized, our
production may be totally or partially suspended, the government may refuse to approve our
marketing applications or allow us to distribute our products and we may be criminally prosecuted.
The FDA also has the authority to revoke previously granted marketing authorizations.
In order to obtain approval of a new product from the FDA, we must, among other requirements,
submit proof of safety and efficacy as well as detailed information on the manufacture and
composition of the product. In most cases, this proof requires documentation of extensive
laboratory tests, and pre-clinical and clinical trials. This testing, and the preparation of
necessary applications and processing of those applications by the FDA, are expensive and typically
take several years to complete. The FDA may not act quickly or favorably in reviewing these
applications, and we may encounter significant difficulties or costs in our efforts to obtain FDA
approvals that could delay or preclude us from marketing any products we may develop. The FDA also
may require post-marketing testing and surveillance to monitor the effects of approved products or
place conditions on any approvals that could restrict the commercial applications of these
products. Regulatory authorities may withdraw product approvals if we fail to comply with
regulatory standards or if we encounter problems following initial marketing. With respect to
patented products or technologies, delays imposed by the governmental approval process may
materially reduce the period during which we might have the exclusive right to exploit the products
or technologies.
After an IND application becomes effective, a sponsor may commence human clinical trials in
the United States. The sponsor typically conducts human clinical trials in three sequential phases,
but these phases may overlap. In Phase I clinical trials, the product is tested in a small number
of patients or healthy volunteers, primarily for safety at one or more doses. In Phase II, in
addition to safety, the sponsor evaluates the efficacy of the product in a patient population
somewhat larger than Phase I clinical trials. Phase III clinical trials typically involve
additional testing for safety and clinical efficacy in an expanded population at geographically
dispersed test sites. The sponsor must submit to the FDA a clinical plan, or protocol, accompanied
by the approval of a clinical site responsible for ongoing review of the investigation, prior to
commencement of each clinical trial. The FDA or a clinical site may order the temporary or
permanent discontinuation of a clinical trial at any time, if the trial is not being conducted in
accordance with FDA or clinical site requirements or presents a danger to its subjects.
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The sponsor must submit to the FDA the results of the pre-clinical and clinical trials,
together with, among other data, detailed information on the manufacture and composition of the
product, in the form of a new drug application or, in the case of a biologic, a biologics license
application. The FDA is regulating our therapeutic vaccine product candidates as biologics and,
therefore, we must submit biologics license applications, or BLA, to the FDA to obtain approval of
our products. The clinical trial process generally takes several years, and the FDA reviews the BLA
and, when and if it decides that adequate data is available to show that the new compound is both
safe and effective and that all other applicable requirements have been met, the FDA approves the
drug or biologic for marketing. The amount of time taken for this approval process is a function of
a number of variables, including the quality of the submission and studies presented, the potential
contribution that the compound will make in improving the treatment of the disease in question, and
the workload at the FDA. It is possible that our product candidates will not successfully proceed
through this approval process or that the FDA will not approve them in any specific period of time.
The FDA may, during its review of a new drug application or biologics license application, ask
for additional test data. If the FDA does ultimately approve a product, it may require
post-marketing testing, including potentially expensive Phase IV studies, and surveillance to
monitor the safety and effectiveness of the drug. In addition, the FDA may in some circumstances
impose restrictions on the use of an approved drug, which may be difficult and expensive to
administer, and may require prior approval of promotional materials.
Before approving a new drug application or biologics license application, the FDA also will
inspect the facilities at which the product is manufactured and will not approve the product unless
the manufacturing facilities are in compliance with guidelines for the manufacture, holding and
distribution of a product. Following approval, the FDA periodically inspects drug and biologic
manufacturing facilities to ensure continued compliance with manufacturing guidelines.
Manufacturers must continue to expend time, money and effort in the areas of production, quality
control, record keeping and reporting to ensure full compliance with those requirements. The
labeling, advertising, promotion, marketing and distribution of a drug or biologic product must
also be in compliance with FDA regulatory requirements. Failure to comply with applicable
requirements can lead to the FDA demanding that production and shipment cease, and, in some cases,
that the manufacturer recall products, or to FDA enforcement actions that can include seizures,
injunctions and criminal prosecution. These failures can also lead to FDA withdrawal of marketing
approval for the product.
We and our partners are also subject to regulation by the Occupational Safety and Health
Administration, the Environmental Protection Agency, the Nuclear Regulatory Commission and other
foreign, federal, state and local agencies under various regulatory statutes, and may in the future
be subject to other environmental, health and safety regulations that may affect our research,
development and manufacturing programs. We are unable to predict whether any agency will adopt any
regulation which could limit or impede on our operations.
Sales of pharmaceutical products outside the United States are subject to foreign regulatory
requirements that vary widely from country to country. Whether or not we have obtained FDA
approval, we must obtain approval of a product by comparable regulatory authorities in foreign
countries prior to the commencement of marketing the product in those countries. The time required
to obtain this approval may be longer or shorter than that required for FDA approval. The foreign
regulatory approval process includes all the risks associated with FDA regulation set forth above,
as well as country-specific regulations.
Employees
We employed seven full-time employees, as of April 21, 2008. Each of our employees has signed
a confidentiality and invention assignment agreement, and none are covered by a collective
bargaining agreement. We have never experienced employment-related work stoppages and consider our
employee relations to be positive.
Properties
Prior to September 2007, we maintained our headquarters in Bothell, Washington where we
currently sublease approximately 2,325 square feet of general administration space. Our current
sublease expires on June 30, 2008. On March 21, 2008, we executed a sublease agreement with Toucan
Capital Corporation, an affiliate of Toucan Capital and Toucan Partners, for our new corporate
headquarters located at 7600 Wisconsin Avenue, Suite Suite 750, Bethesda, Maryland 20814. This
sublease agreement is effective as of July 1, 2007 and expires on October 31, 2016, unless sooner terminated according to its
terms. Previously, we had been occupying our Bethesda headquarters under an oral arrangement with
Toucan Capital Corporation, whereby we were required to pay base rent of $32,949 per month through
December 31, 2007. Under the Sublease Agreement, we are required to pay base rent of $34,000 per
month during the year 2008, which monthly amount increases by $1,000 on an annual basis, to a
maximum of $42,000 per month during 2016, the last year of the term of the lease. In addition to
monthly base rent, we are obligated to pay operating expenses allocable to the subleased premises
under Toucan Capital Corporations master lease.
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Legal Proceedings
From time to time, we are involved in claims and suits that arise in the ordinary course of
our business. Although management currently believes that resolving any such claims against us will
not have a material adverse impact on our business, financial position or results of operations,
these matters are subject to inherent uncertainties and managements view of these matters may
change in the future. In addition to any such claims and suits, we are involved in the following
legal proceedings.
Soma Arbitration
We 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 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 with 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.
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. On June 19, 2007, the Appellate Division, First Department of the Supreme
Court of the State of New York, reversed the December 30, 2005 decision and ordered a new
arbitration proceeding. On July 26, 2007, we filed a Motion for Leave to Appeal with the Court of
Appeals of the State of New York and on August 3, 2007 Soma filed its reply brief. On October 16,
2007, the Court of Appeals of the State of New York denied our motion to appeal. We intend to
continue to vigorously defend ourselves against the claims of Soma.
Lonza Patent Infringement Claim
On July 27, 2007, Lonza Group AG (Lonza) filed a complaint against us in the United States
District Court for the District of Delaware alleging patent infringement relating to recombinant
DNA methods, sequences, vectors, cell lines and host cells. The complaint sought temporary and
permanent injunctions enjoining us from infringing Lonzas patents and unspecified damages. On
November 27, 2007, the complaint was dismissed from the United States District Court for the
District of Delaware. Also on November 27, 2007, a new complaint was filed by Lonza in the United
States District Court for the District of Maryland. The new complaint alleged the same patent infringement relating to recombinant DNA methods, sequences,
vectors, cell lines and host cells by the Companys DCVax®. On December 13, 2007, Lonza withdrew
all of its claims relating to all of our products other than DCVax®-Prostate. We
believe that Lonzas remaining claim is meritless and intend to file a response and vigorously
defend this action.
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Stockholder Class Action Lawsuits
On August 13, 2007, a complaint was filed in the U.S. District Court for the Western District
of Washington naming the Company, the Chairperson of the Board, Linda F. Powers, and our Chief
Executive Officer, Alton L. Boynton, as defendants in a class action for violation of federal
securities laws. After this complaint was filed, five additional complaints were filed in other
jurisdictions alleging similar claims. The complaints were filed on behalf of purchasers of the
Companys common stock between July 9, 2007 and July 18, 2007 and allege violations of Section
10(b) of the Exchange Act and Rule 10b-5 thereunder. The complaints seek unspecified compensatory
damages, costs and expenses. We dispute these claims and intend to vigorously defend these actions.
On December 18, 2007 a consolidated complaint was filed in the U.S. District Court for the
Western District of Washington consolidating the stockholder actions previously filed.
SEC Inquiry
On August 13, 2007, we were notified that the SEC had initiated a non-public informal inquiry
from the SEC regarding the events surrounding our application for Swiss regulatory approval and
related press releases dated July 9, 2007 and July 16, 2007. On March 3, 2008 we were notified that
the SEC had initiated a formal investigation regarding this matter. We have been cooperating with
the SEC in connection with the inquiry, and will continue to do so.
Management Warrants
On November 13, 2003, we borrowed an aggregate of $335,000 from certain members of our
management. As part of the consideration for this loan, the lenders received warrants exercisable
to acquire an aggregate of 0.25 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 0.63 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, in the event such claims are pursued, we intend to vigorously defend against them.
We have no other legal proceedings pending at this time.
MANAGEMENT
Executive Officers and Directors
Our executive officers and directors, and their ages and positions as of April 21, 2008, are
as follows. Their biographies follow the table.
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Name
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Age
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Position
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Alton L. Boynton, Ph.D.
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President, Chief Executive Officer, Secretary and Director
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Anthony P. Deasey
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Senior Vice President of Finance, Chief Financial Officer and Director
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R. Steve Harris
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Director
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Linda F. Powers
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Director, Chairperson
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Alton L. Boynton, Ph.D.
Dr. Boynton co-founded the Company, has served as Secretary since
August 2001, has served as our Chief Scientific Officer and a director since our inception in 1998,
was appointed our Chief Operating Officer in August 2001, was appointed President in May 2003 and
was appointed Chief Executive Officer in June 2007. Dr. Boynton has also served as Director of the
Department of Molecular Medicine of Northwest Hospital from 1995-2003 where he coordinated the
establishment of a program centered on carcinogenesis. Prior to joining Northwest Hospital, Dr.
Boynton was Associate Director of the Cancer Research Center of Hawaii, The University of Hawaii,
where he also held the positions of Director of Molecular Oncology of the Cancer Research Center
and Professor of Genetics and Molecular Biology. Dr. Boynton received his Ph.D. in Radiation
Biology from the University of Iowa in 1972.
Anthony P. Deasey.
Mr. Deasey was elected to the Board on September 28, 2007. Mr. Deasey was
appointed Senior Vice President of Finance, Chief Financial Officer of the Company on October 2,
2007. Prior to joining the Company, from November 2000 to September 2007 Mr. Deasey served as
Executive Vice President, Chief Financial Officer of Celsion Corporation and oncology drug
development company. From 1998 to 2000, he was Senior Vice President and Chief Financial Officer of
World Kitchen Inc. From 1996 to 1998 he served as Senior Vice President and Chief Financial Officer
of Rollerblade Inc. and from 1988 to 1995 he served as Vice President Finance and Chief Financial
Officer of Church and Dwight Co. Inc. Mr. Deasey is a Chartered Accountant who gained his early
experience in the international operations of Chesebrough Ponds and Price Waterhouse.
R. Steve Harris
. Mr. Harris has served as our director since June 2007. Mr. Harris is
currently the non-executive Chairman of Proteome Sciences plc, Convé plc and Sinclair Pharma plc.
He is also a non-executive director of SkyePharma plc, Advanced Medical Solutions plc and Premier
Research plc. Mr. Harris holds a Bachelor of Pharmacy Degree (University of London) and was elected
a Fellow of the Royal Pharmaceutical Society in 2000. Mr. Harris is also a member of the Audit
Committee, Compensation Committee and Nominations Committee.
Linda F. Powers.
Ms. Powers has served as the Chairperson of our Board of Directors since her
appointment on May 17, 2007. Ms. Powers has served as managing director of Toucan Capital
Corporation, a provider of venture capital since 2001. She has over 15 years experience in
corporate finance and restructurings, mergers and acquisitions, joint ventures and intellectual
property licensing. Ms. Powers is a board member of Moffitt Technology Corporation, a for-profit
arm of Moffitt Cancer Center (the third largest cancer center in U.S.), a board member of the
Trudeau Institute, well known for its specialization in immunology, and the Chair of the Maryland
Stem Cell Research Commission, administering the states stem cell funding program. Ms. Powers has
been appointed to three Governors commissions created to determine how to build the respective
states biotech and other high-tech industries. She served as the Deputy Assistant Secretary of
Commerce in the George H. W. Bush, Sr. administration. She was co-lead negotiator for the U.S. on
the North American Free Trade Agreement financial sector agreement, which opened banking,
securities, insurance, pension fund and related opportunities in Canada and Mexico. Ms. Powers
serves on the steering committee of the National Academy of Sciences evaluating Federal grant
programs, and on the Advisory Board of the US Department of Commerce NIST Advanced Technology
Program. Ms. Powers also serves on the boards of directors of six private biotechnology companies.
Ms. Powers holds a B.A. from Princeton University, where she graduated magna cum laude and Phi Beta
Kappa. She also earned a JD degree, magna cum laude, from Harvard Law School. Ms. Powers is also a
member of the Audit Committee, Compensation Committee and Nominations Committee.
Board of Directors
Our Board of Directors consists of two non-employee directors and two directors who are
currently employed by us. The Board has established the following committees:
Audit Committee
The Audit Committee has responsibility for recommending the appointment of our independent
accountants, supervising our finance function (which includes, among other matters, our investment
activities), reviewing our internal accounting control policies and procedures, and providing the
Board such additional information and materials as it may deem necessary to make the Board aware of
significant financial matters which require the attention of the Board. The Audit Committee
provides the opportunity for direct contact between our independent registered public accounting
firm and the Board. The Board has adopted a written charter for the Audit Committee and its current
members, R. Steve Harris and Linda F. Powers, are non-employee directors. The Audit Committee
Chairman is R. Steve Harris.
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Compensation Committee
The Compensation Committee is responsible for determining the overall compensation levels of
our executive officers and administering our stock option plans. The Board has adopted a written
charter for the Compensation Committee and its current members are two non-employee directors, R.
Steve Harris and Linda F. Powers. The Compensation Committee Chairman is R. Steve Harris.
Nominations Committee
The Nominations Committee is responsible for identifying and nominating members of the Board,
recommending directors to be appointed to each committee of the Board and the chair of such
committees, and overseeing the evaluation of the Board. The Board has adopted a written charter for
the Nominations Committee and its current members are two non-employee directors, R. Steve Harris
and Linda F. Powers. The Nominations Committee Chairperson is Linda F. Powers. The Nominations
Committee will consider nominees recommended by stockholders pursuant to the procedures outlined in
our Bylaws. No Nominations Committee meetings were held during the year ended December 31, 2007.
It is the Boards intention to appoint additional independent non-executive directors to these
committees in due course.
We have adopted a code of ethics meeting the definition of Code of Ethics as defined in Item
406 of Regulation S-K . Our Code of Ethics is applicable to the chief executive officer, the chief
financial officer, the principal accounting officer or persons performing similar functions. Our
code of ethics is posted on our website and may be accessed at
www.nwbio.com/about_code.php
. We will post to our website any amendments to our code of
ethics and any waivers granted under the code to any of our directors or executive officers.
One of our directors, R. Steve Harris, is an independent director as defined by NASDAQ
listing standards and none of our directors meets the definition of an audit committee financial
expert as defined by the SEC. We intend to recruit one or more additional non-executive directors
in due course, including one person who qualifies as an audit committee financial expert, but may
not be able to do so.
COMPENSATION OF EXECUTIVE OFFICERS AND DIRECTORS
Compensation Discussion and Analysis
Our Process
Typically, our executive compensation is comprehensively assessed and analyzed annually;
however, given our limited funding since 2002, our executives have received infrequent increases in
their compensation. During 2006, our executives did not receive an increase in their base salaries.
During 2007, our Chief Technical Officer received an increase in base salary based on performance
and in order to take steps to be more competitive in the market. During 2007, our executives also
received equity based incentives. Normally, the review process includes, but is not limited to, the
following steps:
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The Compensation Committee reviews the performance of the Chief Executive Officer and
other senior executives;
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The current annual compensation of senior management and long-term compensation grants
made over the past few years are reviewed;
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The appropriate performance metrics and attributes of annual and long-term programs for
the next year are considered and discussed;
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The entirety of our compensation program is considered;
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|
For our top officers, if peer group compensation is available for their position, we use
a blend of survey and peer compensation for comparison, as we compete not only in our own
market, but nationally and across industries, for talent;
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The compensation practices of our peer companies are reviewed, including their practices
with respect to equity and other grants, benefits and perquisites;
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|
The compensation of our management team from the standpoint of internal equity,
complexity of the job, scope of responsibility and other factors is assessed; and
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Managements stock ownership is reviewed.
|
Management has the following involvement with the executive compensation process:
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|
The Chief Executive Officer reviews recommendations from the Chief Financial Officer
regarding salaries, annual and long-term incentive targets, and plan amendments and design
before recommendations are submitted to the Compensation Committee for approval; and
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|
|
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The Chief Executive Officer and Chief Financial Officer are both involved in establishing
and recommending to the Compensation Committee financial goals for the incentive programs
based on managements operational goals and strategic plans.
|
Compensation Goals
Our philosophy regarding executive compensation is to attract and retain highly qualified
people by paying competitive salaries, and to link the financial interests of our senior management
to those of our stockholders by tying compensation to the achievement of operational and financial
objectives. Our compensation package for our officers includes both short-term and long-term
features in the forms of base salary and equity-based incentives in the form of stock options,
which are granted periodically at the discretion of the Compensation Committee.
Elements of Executive Compensation
Base Salaries
Base salaries for all executive officers are reviewed annually. The Compensation Committee
reviews the compensation of the President and Chief Executive Officer. The President and Chief
Executive Officer reviews the compensation of the other executive officers. The Compensation
Committee also consults with the President and Chief Executive Officer with respect to the
compensation package for all other executive officers. In evaluating salaries, each officers
individual performance during the prior year, as well as salary levels in the biotechnology
industry for comparable positions, are considered. In determining how the respective officer
contributes to the Company, current corporate performance, as well as the potential for future
performance gains, are considered. No specific weight is attributed to the foregoing for purposes
of determining base salaries.
Equity-Based Incentives
We provide our executive officers with long-term incentives through our 1998 Plan, 1999 Plan,
2001 Plan, Employee Plan and beginning in 2007, our 2007 Stock Option Plan (each, as defined under
Equity Plans below), all described in more detail below. On June 22, 2007, we amended the 1998
Plan, 1999 Plan, 2001 Plan and Employee Plan such that no further stock option grants may be made
under any of such plans. The primary objective of these plans is to provide an incentive for
employees, including our executive officers, to make decisions and take actions that maximize
long-term stockholder value. The plans are designed to promote this long-term focus by using
discretionary grants and long-term vesting periods. Subject to the terms of the plans, the
Compensation Committee determines the terms and conditions of options granted under the plans,
including the exercise price, which is based on fair value of our stock on the date of grant. For
various motivation and retention considerations, option awards granted subsequent to our initial
public offering in December 2001 generally vest over four years. The Compensation Committee
believes that stock options provide an incentive for employees, allowing us to attract and retain high quality management
and staff. Although, we did not issue any stock options to our executives during the year ended
December 31, 2006, we did issue stock options to our executives in 2007.
54
Employee and Executive Benefits
Our executives participate in many of the same employee benefit programs as our other
employees. The core employee benefit programs include a tax-qualified retirement plan, medical
coverage, dental coverage, life insurance, disability coverage, and vacation. The tax qualified
retirement plan is a 401(k) plan. We made matching contributions to each employees 401(k) plan
account of $0.50 for each dollar contributed on the first $3,000 of compensation contributed to the
plan. Our matching contribution policy was terminated effective March 2006. All of these matching
contribution amounts to our Named Executive Officers are shown in the
All Other Compensation
footnote to the Summary Compensation Table following this section.
Perquisites
Historically, we have offered only a very limited number of perquisites to our executives as
an incremental benefit to recognize their position within the Company. No perquisites of any kind
were offered to executives in 2007.
Compensation of the President and Chief Executive Officer
In assembling the compensation package for our President and Chief Executive Officer, the
Compensation Committee considers our annual and long-term performance, the performance of the
President and Chief Executive Officer, and our cash resources and needs. Although the Committees
overall goal is to set the President and Chief Executive Officers salary at the median level for
competitors that are similar in industry size and performance, the actual level approved by the
Committee may be higher or lower based upon the Committees subjective evaluation of the foregoing.
Consistent with the foregoing, the Compensation Committee set the base salary for the President and
Chief Executive Officer at $331,250 for fiscal 2007. The President and Chief Executive Officer did
not receive a bonus for 2007. In connection with our initial public offering on AIM, the Board of
Directors committed to award the President and Chief Executive Officer an option to purchase shares
of our common stock. This stock option award, which is shown in the Grants of Plan-Based Awards
table below, was granted in December 2007.
Accounting for Stock-based Compensation
Effective January 1, 2006, we measure and recognize compensation expense in accordance with
SFAS No. 123(R), which requires that compensation expense relating to share-based payment
transactions be recognized in the financial statements based on the fair value of the equity or
liability instruments issued.
Prior to January 1, 2006, we accounted for our stock-based compensation plans under the
measurement and recognition provision of Accounting Principles Board Opinion No. 25,
Accounting for
Stock Issued to Employees
, and related interpretations. Under this method, stock option awards
generally did not result in compensation expense, since their exercise price was typically equal to
the market price of our common stock on the date of grant.
The Compensation Committee considers the accounting treatment of equity and performance based
compensation when approving awards.
55
REPORT OF THE COMPENSATION COMMITTEE
1
We, the Compensation Committee of the Board of Directors, have reviewed and discussed the
Compensation Discussion and Analysis (CD&A) within the Executive Compensation section of this
Annual Report on Form 10-K with the management of the Company. Based on such review and discussion,
we have recommended to the Board of Directors that the CD&A be included in the Companys Annual
Report on Form 10-K for the year ending December 31, 2007.
Submitted by the Compensation Committee of the Board of Directors:
|
|
|
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Linda F. Powers
R. Steve Harris, Chairman
|
|
|
Summary Compensation
We did not issue any option or stock awards to our executives in the year ended December 31,
2006. We granted options to our newly appointed Chief Financial Officer in October 2007, and
granted options to our Chief Executive Officer and other staff in December 2007.
Summary Compensation Table
The following table sets forth certain information concerning compensation paid or accrued to
our named executive officers (the Named Executive Officers) during the years ended December 31,
2007 and 2006.
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|
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|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
All Other
|
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|
Name and Principal
|
|
|
|
|
|
|
|
|
|
|
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|
Option Awards
|
|
Compensation
|
|
|
Position
|
|
Year
|
|
Salary
|
|
Bonus
|
|
(3)
|
|
(1)
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|
Total
|
Alton L. Boynton, Ph.D.
|
|
|
2007
|
|
|
$
|
331,250
|
|
|
|
|
|
|
$
|
2,011,680
|
|
|
$
|
1,828
|
|
|
$
|
2,344,758
|
|
President, Chief Executive
Officer, Chief Scientific
Officer and Secretary (2)
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2006
|
|
|
$
|
330,802
|
|
|
|
|
|
|
|
|
|
|
$
|
2,993
|
|
|
$
|
333,795
|
|
Anthony P. Deasey
|
|
|
2007
|
|
|
$
|
63,462
|
|
|
|
|
|
|
$
|
115,268
|
|
|
|
|
|
|
$
|
178,730
|
|
Senior Vice President and
Chief Financial Officer
(4)
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2006
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
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|
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James D.
Johnston(5)
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2007
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|
$
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96,718
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
96,718
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|
Chief Financial Officer and
General Counsel
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|
|
2006
|
|
|
|
|
|
|
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|
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|
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|
|
|
|
|
|
Marnix L. Bosch, Ph.D.,
M.B.A.
|
|
|
2007
|
|
|
$
|
224,980
|
|
|
|
|
|
|
$
|
471,661
|
|
|
$
|
482
|
|
|
$
|
697,123
|
|
Chief Technical Officer
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|
|
2006
|
|
|
$
|
167,021
|
|
|
|
|
|
|
$
|
1,344
|
|
|
$
|
982
|
|
|
$
|
169,347
|
|
|
|
|
(1)
|
|
All Other Compensation for the years ended December 31, 2007 and 2006 consisted of
Company-paid premiums on term life insurance coverage up to 1.5 times the employees annual
salary, earned but unpaid accrued vacation payments. Additionally in 2006, the Company
provided matching contributions to the employees 401(k) plan accounts up to a maximum of
$3,000.
|
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(2)
|
|
Dr. Boynton was appointed as our Chief Executive Officer in June 2007. Dr. Boynton served as
our Chief Operating Officer and our principal executive officer during 2006.
|
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(3)
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Represents the amount recognized for financial statement reporting purposes for 2007 and 2006
in respect of outstanding option awards in accordance with SFAS No. 123R, excluding any impact
of assumed forfeiture rates. The assumptions made in valuing option awards reported in this
column are discussed in Note 3, Stock-Based Compensation Plans to the Companys consolidated
financial statements for the year ended December 31, 2006, included elsewhere in this
prospectus.
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(4)
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Effective October 1, 2007, we named Anthony P. Deasey as our Chief Financial Officer.
|
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(5)
|
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Effective March 1, 2007, we named James D. Johnston as our Chief Financial Officer and General
Counsel. Mr. Johnston resigned from these positions effective August 28, 2007.
|
Given our financial status, there are no regularly scheduled increases in compensation.
|
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1
|
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The material in this report is not soliciting
material, is not deemed filed with the SEC, and is not to be incorporated by
reference into any of our filings under the Securities Act or the Exchange Act,
whether made before or after the date hereof and irrespective of any general
incorporation language contained in such filing.
|
56
Grants of Plan-Based Awards in 2007
The following table provides information about equity awards granted to the Named Executive
Officers during the year ended December 31, 2007. We did not grant any stock appreciation rights or
restricted stock to Named Executive Officers during the fiscal year ended December 31, 2007. Grants
of stock options were made under the 2007 Stock Option Plan.
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All Other Option
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|
Exercise or
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Awards: Number of
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Base Price of
|
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Grant Date
|
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Grant Date Value
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|
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|
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Securities
|
|
Option Awards
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|
Closing Price
|
|
of Option
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Name
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Grant Date
|
|
Underlying Options
|
|
(5)
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of Common Stock
|
|
Awards(6)
|
Dr. Alton Boynton
|
|
|
12/31/2007
|
|
|
|
2,807,048
|
(1)
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$
|
0.60
|
|
|
$
|
2.54
|
|
|
$
|
7,016,782
|
|
Anthony P. Deasey
|
|
|
10/1/2007
|
|
|
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769,208
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(2)
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$
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2.40
|
|
|
$
|
2.40
|
|
|
$
|
1,884,285
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|
James D. Johnston
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(3)
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|
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|
|
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Marnix L. Bosch
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|
|
12/31/2007
|
|
|
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1,081,539
|
(4)
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$
|
0.60
|
|
|
$
|
2.54
|
|
|
$
|
2,703,524
|
|
|
|
|
(1)
|
|
This option was granted under the 2007 Stock Option Plan. This option grant vests over a
three and one-half year period. Approximately 29% the option grant was vested immediately upon
grant with respect to prior service performed. Approximately 17% vests on the first
anniversary of the AIM offering (June 22, 2008) and the remaining portion vests in equal
monthly installments over the remaining three year vesting period.
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(2)
|
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Mr. Deaseys options were granted under the 2007 Stock Option Plan. Mr. Deaseys option grant
vests over a four year period. One-fourth of the option grant vests on the first anniversary
of the grant date and the remaining three-fourths of the grant vests in equal monthly
installments over the remaining three year vesting period.
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(3)
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Mr. Johnstons stock option award for 2007 has not yet been determined and is subject to
continuing discussion and consideration from the Compensation Committee of the Board of
Directors.
|
|
(4)
|
|
This option was granted under the 2007 Stock Option Plan. This option grant vests over a
three and one-half year period. Approximately 19% of the option grant was vested immediately
upon grant with respect to prior service performed. Approximately 21% vests on the first
anniversary of the AIM offering (June 22, 2008) and the remaining portion vests in equal
monthly installments over the remaining three year vesting period.
|
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(5)
|
|
This column shows the exercise price of stock option awards. The exercise price of the
options granted to Mr. Deasey is equal to the closing price of the Companys common stock on
the grant date. The exercise prices of the options granted to Messrs. Boynton and Bosch are
equal to the conversion price of warrants issued to Toucan Partners under the Conversion
Agreement.
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(6)
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|
This column shows the full grant date fair value of stock options under SFAS No. 123(R)
granted to the Named Executive Officers in 2007. Generally, the grant date fair value is the
amount that the Company would record as compensation expense in its financial statements over
the awards vesting schedule, excluding the impact of forfeiture assumptions.
|
57
Outstanding Equity Awards at Fiscal Year-End
The following table shows outstanding stock option awards classified as exercisable and
unexercisable as of December 31, 2007.
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|
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|
|
|
|
|
|
(a)
|
|
(b)
|
|
(c)
|
|
(d)
|
|
(e)
|
|
|
Number of
|
|
Number of
|
|
|
|
|
|
|
Securities
|
|
Securities
|
|
|
|
|
|
|
Underlying
|
|
Underlying
|
|
|
|
|
|
|
Unexercised
|
|
Unexercised
|
|
Option
|
|
|
|
|
Options
|
|
Options
|
|
Exercise
|
|
Option
|
|
|
(#)
|
|
(#)
|
|
Price
|
|
Expiration
|
Name
|
|
Exercisable
|
|
Unexercisable
|
|
($)
|
|
Date
|
Alton L. Boynton
|
|
|
11,014
|
(1)
|
|
|
0
|
|
|
$
|
12.85
|
|
|
|
11/16/09
|
|
|
|
|
5,286
|
(1)
|
|
|
0
|
|
|
|
18.75
|
|
|
|
04/18/11
|
|
|
|
|
6,666
|
(1)
|
|
|
0
|
|
|
|
1.35
|
|
|
|
2/18/13
|
|
|
|
|
804,768
|
(2)
|
|
|
2,002,280
|
|
|
|
0.60
|
|
|
|
12/31/11
|
|
Anthony P. Deasey (3)
|
|
|
|
|
|
|
769,208
|
|
|
|
2.40
|
|
|
|
10/1/17
|
|
James D. Johnston (6)
|
|
|
1,667
|
|
|
|
0
|
|
|
|
3.15
|
|
|
|
3/18/15
|
|
Marnix L. Bosch
|
|
|
1,000
|
(4)
|
|
|
0
|
|
|
|
12.75
|
|
|
|
5/16/10
|
|
|
|
|
333
|
(4)
|
|
|
0
|
|
|
|
18.75
|
|
|
|
11/14/10
|
|
|
|
|
333
|
(4)
|
|
|
0
|
|
|
|
18.75
|
|
|
|
09/20/11
|
|
|
|
|
833
|
(4)
|
|
|
0
|
|
|
|
75.00
|
|
|
|
01/10/12
|
|
|
|
|
3,194
|
(4)
|
|
|
139
|
|
|
|
1.35
|
|
|
|
2/18/13
|
|
|
|
|
4,000
|
(4)
|
|
|
1,333
|
|
|
|
1.80
|
|
|
|
12/01/13
|
|
|
|
|
188,687
|
(5)
|
|
|
892,852
|
|
|
|
0.60
|
|
|
|
12/31/11
|
|
|
|
|
(1)
|
|
These options were granted under the 1999 Plan, the 2001 Plan and under Dr. Boyntons
previous employment agreement. Each of these option grants vests over a four year period.
One-fourth of each option grant vests on the first anniversary of the grant date and the
remaining three-fourths of each grant vests in equal monthly installments over the remaining
three year vesting period.
|
|
(2)
|
|
This option was granted under the 2007 Stock Option Plan. This option grant vests over a
three and one-half year period. Approximately 29% the option grant was vested immediately upon
grant with respect to prior service performed. Approximately 17% vests on the first
anniversary of the AIM offering (June 22, 2008) and the remaining portion vests in equal
monthly installments over the remaining three year vesting period. These options were granted
in recognition of past service to the Company and have an exercise price of $0.60 per share,
which is equal to the conversion price of warrants issued to Toucan Partners under the
Conversion Agreement.
|
|
(3)
|
|
Mr. Deaseys options were granted under the 2007 Stock Option Plan, at the closing price on
the date of grant. Mr. Deaseys option grant vests over a four year period. One-fourth of the
option grant vests on the first anniversary of the grant date and the remaining three-fourths
of the grant vests in equal monthly installments over the remaining three year vesting period.
|
|
(4)
|
|
These options were granted under the 1999 Plan and the 2001 Plan. Each of these option grants
vests over a four year period. One-fourth of each option grant vests on the first anniversary
of the grant date and the remaining three-fourths of each grant vests in equal monthly
installments over the remaining three year vesting period.
|
|
(5)
|
|
This option was granted under the 2007 Stock Option Plan. This option grant vests over a
three and one-half year period. Approximately 19% of the option grant was vested immediately
upon grant with respect to prior service performed. Approximately 21% vests on the first
anniversary of the AIM offering (June 22, 2008) and the remaining portion vests in equal
monthly installments over the remaining three year vesting period. These options were granted
in recognition of past service to the Company and have an exercise price of $0.60 per share,
which is equal to the conversion price of warrants issued to Toucan Partners under the
Conversion Agreement.
|
|
(6)
|
|
These options were granted prior to Mr. Johnstons employment with us and are fully vested.
|
58
Option Exercises and Stock Vested
No options were exercised by and no stock awards vested for the Named Executive Officers
during 2007.
Pension Plans, Deferred Compensation and Severance Agreements
We do not currently offer any such plans or compensation or have any such agreements in place.
Directors Compensation
The following table sets forth certain information concerning compensation paid or accrued to
our non-executive directors during the year ended December 31, 2007.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fees Earned
|
|
All Other
|
|
|
|
|
|
|
|
|
or Paid
|
|
Compensation
|
|
|
Name
|
|
Year
|
|
in Cash
|
|
(1)
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Linda F. Powers
|
|
|
2007
|
|
|
$
|
60,970
|
|
|
$
|
|
|
|
$
|
60,970
|
|
R. Steve Harris
|
|
|
2007
|
|
|
$
|
35,707
|
|
|
$
|
|
|
|
$
|
35,707
|
|
Only non-employee directors receive director fees. Effective June 22, 2007, we are required to
pay Linda F. Powers, as Chairperson and a non-executive member of the Board of Directors, £50,000
(approximately $100,000) per annum for her services. Also effective June 22, 2007, we are required
to pay R. Steve Harris, as a non-executive member of the Board of Directors, £30,000 (approximately
$60,000) per annum for his services.
Compensation Committee Interlocks and Insider Participation
From January 1, 2007 to June 22, 2007, Dr. Boynton was the sole member of our Compensation
Committee and served as our President, Chief Operating Officer and Chief Scientific Officer. In
addition, as discussed further under Transactions with Related Persons below, in 2006, Dr.
Boynton exercised warrants and convertible loans covering 126,365 and 146,385 shares of our common
stock, respectively. In June 2007, Dr. Boynton was replaced by Linda F. Powers and R. Steve Harris
as members of the Compensation Committee. During 2007, none of our executive officers served as a
member of the compensation committee (or other committee serving an equivalent function) of any
other entity, one of whose executive officers served as a director on our Board or as a member of
our Compensation Committee. None of our executive officers served during 2007 as a director of any
other entity, one of whose executive officers served as a director on our Board or as a member of
our Compensation Committee.
Equity Plans
We maintain several plans under which our directors and employees may be granted equity
awards, generally in the form of stock options. A brief description of these plans follows. The
Company amended its then existing equity plans effective June 22, 2007 such that no further option
grants may be made under those plans.
1998 Stock Plan
The 1998 Stock Plan (the 1998 Plan) was adopted by our Board of Directors in July 1998 and
approved by our stockholders in February 1999. This plan provided for the grant to our employees,
including officers and employee directors, of incentive stock options within the meaning of
Section 422 of the Internal Revenue Code of 1986, as amended (the Code), and for the grant of
non-statutory stock options to our employees, officers, directors, including non-employee
directors, and consultants. To the extent an optionee would have the right in any calendar year to
exercise for the first time one or more incentive stock options for shares having an aggregate fair
market value, under all of our plans and determined as of the grant date, in excess of $100,000,
any such excess options will be treated as non-statutory options. A total of 27,535 shares of our
common stock have been reserved for issuance under this plan and, as of December 31, 2007, net of
forfeitures, a total of 23,783 of such shares remained available for additional option grants.
59
The Compensation Committee of our Board of Directors serves as the administrator of our 1998
Stock Plan. Subject to the terms of this plan, the administrator determines the terms of options
granted, including the number of shares subject to the option, exercise price, term and
exercisability. The exercise price of all incentive stock options granted under this plan must be
at least equal to the fair market value of our common stock on the date of grant. The exercise
price of any incentive stock option granted to an optionee who owns stock representing more than
10% of the total combined voting power of our outstanding capital stock, or a 10% Stockholder, must
be at least equal to 110% of the fair market value of our common stock on the date of grant. The
exercise price of all non- statutory stock options cannot be less than 85% of the fair market value
of our common stock on the date of grant, and in the case of 10% Stockholders, the exercise price
cannot be less than 110% of the fair market value of our common stock. The term of options granted
under this plan may not exceed 10 years, and the term of an incentive stock option granted to a 10%
Stockholder may not exceed five years. An option may not be transferred by the optionee other than
by will or the laws of descent or distribution. Each option may be exercised during the lifetime of
the optionee only by such optionee. Generally, each option granted under this plan becomes
exercisable as to 25% of the total number of shares subject to the option after the first
anniversary following the date of grant, with subsequent equal monthly vesting over three years,
subject to the optionees continued relationship with us as an employee, director or consultant, as
the case may be.
Our Board of Directors has the authority to amend or terminate this plan, but such action will
not adversely affect any outstanding option without the optionees consent. If not terminated
earlier, this plan will terminate in July 2008.
1999 Executive Stock Plan
The 1999 Executive Stock Plan (the 1999 Plan) was adopted by our Board of Directors in
November 1999. This plan provided for the grant of non-statutory stock options to our employees,
officers, directors, including non-employee directors, and consultants. A total of 39,078 shares of
our common stock have been reserved for issuance under this plan, and, as of December 31, 2007, net
of forfeitures, a total of 28,064 shares remained available for granting under this plan.
The Compensation Committee of our Board of Directors serves as the administrator of this plan.
Subject to the terms of this plan, the administrator determines the terms of options granted,
including the number of shares subject to the option, exercise price, term and exercisability. The
exercise price of options under this plan cannot be less than 85% of the fair market value of our
common stock on the date of grant and, in the case of 10% Stockholders, the exercise price cannot
be less than 110% of the fair market value of our common stock on the date of grant. The term of
options granted under this plan may not exceed 10 years. An option may not be transferred by the
optionee other than by will or the laws of descent or distribution. Each option may be exercised
during the lifetime of the optionee only by such optionee. Each option granted under this plan
becomes exercisable as to 25% of the total number of shares subject to the option on the first
anniversary following the date of grant, with subsequent equal monthly vesting over three years,
subject to the optionees continued relationship with us as an employee or consultant.
Our Board of Directors has the authority to amend or terminate this plan, but such action will
not adversely affect any outstanding option without the optionees consent. If not terminated
earlier, this plan will terminate in November 2009.
2001 Stock Plan
The 2001 Stock Plan (the 2001 Plan) was both adopted by our Board of Directors and approved
by our stockholders in June 2001. A total of 120,000 shares of our common stock have been initially
reserved for issuance under this plan. This plan was intended to provide for the grant to our
employees, including officers and employee directors, of incentive stock options within the
meaning of Section 422 of the Code and for the grant of non-statutory stock options to our
employees and consultants. The number of shares available for grant under this plan is subject to
an automatic annual increase in an amount equal to the lesser of (i) 15% of the aggregate number of
shares available for granting for the immediately preceding year; or (ii) 20,000 shares. As of
December 31, 2007, net of forfeitures, a total of 162,603 shares remained available under this
plan.
The Compensation Committee of our Board of Directors serves as the administrator of this plan.
Subject to the terms of this plan, the administrator determines the terms of options granted,
including the number of shares subject to the option, exercise price, term and exercisability. The
exercise price of all incentive stock options granted under this plan must be at least equal to the
fair market value of our common stock on the date of grant. The term of incentive stock options
granted under this plan generally may not exceed 10 years.
60
Our Board of Directors has the authority to amend or terminate this plan, but such action may
not adversely affect any outstanding option previously granted under the plan. If this plan is not
terminated earlier, no incentive stock options can be granted under the plan on or after the later
of June 2011 or the 10th anniversary of the date when our Board of Directors adopted, subject to
approval by our stockholders, the most recent increase in the number of shares available for grant
under the plan.
2001 Non-employee Director Stock Incentive Plan
The 2001 Non-employee Director Stock Incentive Plan (the Directors Plan) was adopted by our
Board of Directors in June 2001. This plan provided for the automatic grant to each of our
nonemployee directors of a nonstatutory stock option to purchase 333 shares of our common stock on
the third business day following each annual meeting of our stockholders. A total of 13,333 shares
of common stock have been reserved for issuance under this plan and, as of December 31, 2007, net
of forfeitures, a total of 10,500 shares remained available under this plan.
This plan is administered by the Compensation Committee of our Board of Directors. The
exercise price of each option granted pursuant to this plan is the fair market value of the
underlying shares of our common stock on the date of grant. Each option granted pursuant to this
plan generally becomes exercisable upon six months after the date of grant, subject to certain
limitations. Our Board of Directors has the authority to amend or terminate this plan, but such
action may not adversely affect any outstanding option without the optionees consent.
Employee Stock Purchase Plan
Our Employee Stock Purchase Plan (the Employees Plan) was adopted by our Board of Directors
and approved by our stockholders in June 2001. A total of 33,333 shares of common stock have been
reserved for issuance under this plan and, as of December 31, 2007, 958 shares have been issued
under this plan.
This plan is administered by the Compensation Committee of our Board of Directors and provides
a mechanism for eligible employees to purchase shares of our common stock. To facilitate these
purchases, eligible participants are assigned plan accounts, to which they may contribute funds via
payroll deduction. The purchases are accomplished through the use of six-month offering periods.
Purchases pursuant to this plan are made at a price equal to the lower of (i) 85% of the fair
market value of our common stock on the last trading day in the offering period; or (ii) 85% of the
fair market value of our common stock on the last trading day before the commencement of such
offering period. No participant may purchase more than 67 shares of our common stock during any
offering period. Additionally, purchases under the plan are limited such that no participant may
purchase under the plan, in any offering period that commenced in that calendar year, shares with a
fair market value in excess of $25,000 minus the fair market value of any shares that the
participant previously purchased in that calendar year. In the case of shares purchased during an
offering period that commenced in the preceding calendar year, the limitation is $50,000 minus the
fair market value of any shares that the participant purchased during the calendar year of the
purchase and the calendar year immediately preceding such purchase.
Our Board of Directors has the authority to amend or terminate this plan at any time.
Amendments to the plan are subject to approval by our stockholders to the extent required by
applicable law.
2007 Stock Option Plan
We established a new stock option plan, which became effective on June 15, 2007 (the 2007
Stock Option Plan). In connection with the Boards adoption of the 2007 Stock Option Plan, we
reserved a total of 5,480,868 shares of common stock for issuance in respect of options granted
under the plan. The plan provides for the grant to our employees, as well as parent company, if
any, and subsidiaries, including officers and employee directors, of incentive stock options
within the meaning of Section 422 of the Code and for the grant of non-statutory stock options to
the employees, officers, directors, including non-employee directors, and consultants of the
Company, its parents and subsidiaries. To the extent an optionee would have the right in any
calendar year to exercise for the first time one or more incentive stock options for shares having
an aggregate fair market value, under all of our plans and determined as of the grant date, in
excess of $100,000, any such excess options will be treated as non-statutory options. As of
December 31, 2007, net of forfeitures, a total of 756,406 shares remained available for issuance
under this plan.
61
Employment Agreements
On October 1, 2007, an employment agreement between us and Anthony P. Deasey became effective.
Under the terms of the agreement, Mr. Deasey is employed as our Chief Financial Officer and Senior
Vice President of Finance for four years of service. Pursuant to the terms of the agreement, Mr.
Deasey is paid annual compensation of $275,000 for his services. The agreement provides for
standard benefits, including coverage under our medical, dental, vision, life and disability
polices. Mr. Deasey is eligible to participate in our 401(k) plan and to receive a bonus at the
discretion of the Board. In connection with his employment with us, Mr. Deasey is subject to a
noncompetition obligation for one year following the termination of his employment with us.
Except as relates to the vesting of Mr. Deaseys stock options, Mr. Deasey is not entitled to
any benefits upon the termination of his employment or a change-in-control of the Company under his
employment agreement. With respect to Mr. Deaseys stock options,
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if his employment with us is terminated for Cause (as defined below), Mr. Deaseys
unvested stock options as of the date of termination will be forfeited, and Mr. Deaseys
stock options that have vested as of the date of termination will expire 24 hours after such
termination date. Cause is defined under Mr. Deaseys employment agreement as, but is not
limited to, malfeasance, material non-performance or materially inadequate performance by
Mr. Deasey of his duties to us following written notice or other communication from the
Board of such inadequate performance and a one-time reasonable cure period.
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if his employment with us is terminated without Cause, Mr. Deaseys unvested stock
options will continue to vest in accordance with their respective vesting schedules until
the last day of employment and will be exercisable for up to 120 days following termination.
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if Mr. Deasey resigns from his employment with us for any reason, Mr. Deaseys unvested
stock options as of the last date of employment will be forfeited. If Mr. Deasey resigns
upon (i) at least 60 days advance notice if his resignation is prior to October 1, 2009 and
(ii) at least 30 days advance notice if his resignation is subsequent to October 1, 2009,
and during the period between the giving of his resignation notice and the effective date of
his resignation, devotes his best efforts, in good faith, to our business and any personnel
transition, then his stock options which have vested as of the effective date of his
resignation will be exercisable for 60 days following the last day of his employment with
us. If Mr. Deaseys resignation does not comply with the notice, best efforts and good faith
requirements described above, then his stock options which have vested as of the effective
date of his resignation will be exercisable for one business day following the last day of
his employment with us.
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On June 22, 2007, an employment agreement between us and Alton L. Boynton, Ph.D. became
effective. Under the terms of the agreement, Dr. Boynton is employed as our President and Chief
Executive Officer. Pursuant to the terms of the agreement, Dr. Boynton is paid annual compensation
of $331,250 for his services. The agreement provides for standard benefits, including coverage
under our medical, dental, vision, life and disability polices. Dr. Boynton is eligible to
participate in our 401(k) plan and to receive a bonus at the discretion of the Board. In connection
with his employment with us, Dr. Boynton is subject to a noncompetition obligation for one year
following the termination of his employment with us.
Except as relates to the vesting of Dr. Boyntons stock options, Dr. Boynton is not entitled
to any benefits upon the termination of his employment or a change-in-control of the Company under
his employment agreement. With respect to Dr. Boyntons stock options,
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if his employment with us is terminated for Cause (as defined below), Dr. Boyntons
unvested stock options as of the date of termination will be forfeited, and Dr. Boyntons
stock options that have vested as of the date of termination will expire 24 hours after such
termination date. Cause is defined under Dr. Boyntons employment agreement as, but is not
limited to, malfeasance, material non-performance or materially inadequate performance by
Dr. Boynton of his duties to us following written notice or other communication from the
Board of such inadequate performance and a one-time reasonable cure period.
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62
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if his employment with us is terminated without Cause, Dr. Boyntons unvested stock
options will continue to vest in accordance with their respective vesting schedules and will
be exercisable during their full exercise period,
if
Dr. Boynton (a) executes a separation
and release agreement reasonably acceptable to us and (b) agrees not to do not work for or
with a company that is developing immunotherapies for cancer in any capacity (including as
an employee, director, adviser or collaborator) while any vesting period is continuing.
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if Dr. Boynton resigns from his employment with us for any reason, Dr. Boyntons unvested
stock options as of the date of resignation will be forfeited. If Dr. Boynton resigns upon
at least 90 days advance notice, and during the period between the giving of his resignation
notice and the effective date of his resignation, devotes his best efforts, in good faith,
to our business and any personnel transition, then his stock options which have vested as of
the effective date of his resignation will be exercisable for 90 days following the last day
of his employment with us. If Dr. Boyntons resignation does not comply with the notice,
best efforts and good faith requirements described above, then his stock options which have
vested as of the effective date of his resignation will be exercisable for 15 days following
the last day of his employment with us.
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On June 22, 2007, the employment agreement between us and James D. Johnston, our former CFO,
became effective. Under the terms of the agreement, Mr. Johnston was employed as our Chief
Financial Officer and General Counsel. Pursuant to the terms of the agreement, Mr. Johnston was to
be paid annual compensation of $180,000 for his services. Mr. Johnston was required to devote 60
percent of his time to our business. The agreement provided for standard benefits, including
coverage under our medical, dental, vision, life and disability polices. Mr. Johnston was eligible
to participate in our 401(k) plan and to receive a bonus at the discretion of the Board. On August
23, 2007, Mr. Johnston resigned from his positions of Chief Financial Officer and General Counsel
of the Company, and as a member of the Board of Directors and all committees thereof, each
effective on August 28, 2007. Mr. Johnston is not subject to a noncompetition obligation following
the termination of his employment with us.
TRANSACTIONS WITH RELATED PERSONS
Since 2004, we have undergone a significant recapitalization pursuant to which Toucan Capital
loaned us an aggregate of $6.75 million, which loans were converted into shares of our Series A-1
Preferred Stock in April 2006, and Toucan Partners loaned us an aggregate of $4.825 million
(excluding $225,000 in proceeds from a demand note that was received on June 13, 2007 and repaid on
June 27, 2007). Our Chairperson, Linda F. Powers, is a managing director of Toucan Capital and a
managing member of Toucan Partners.
Toucan Partners loaned us $4.825 million in a series of transactions. From November 14, 2005
through March 9, 2006, we issued three promissory notes to Toucan Partners, pursuant to which
Toucan Partners loaned us an aggregate of $950,000. In addition to the $950,000 of promissory
notes, Toucan Partners provided $3.15 million in cash advances from October 2006 through April
2007, which were converted into the 2007 Convertible Notes and 2007 Warrants in April 2007. In
April 2007, the three promissory notes were amended and restated to conform to the 2007 Convertible
Notes. Payment was due under the notes upon written demand on or after June 30, 2007. Interest
accrued at 10% per annum, compounded annually, on a 365-day year basis. The principal amount of,
and accrued interest on, these notes, as amended, was convertible at Toucan Partners election into
common stock on the same terms as the 2007 Convertible Notes.
Toucan Partners also entered into two promissory notes with us to fix the terms of two
additional cash advances provided by Toucan Partners to us on May 14, 2007 and May 25, 2007 in the
aggregate amount of $725,000, and we issued warrants to purchase shares of our common stock to
Toucan Partners in connection with each such note. These notes and warrants are on the same terms
as the 2007 Convertible Notes and 2007 Warrants and the proceeds of these notes enabled us to
continue to operate and advance programs while raising additional equity financing.
During the fourth quarter of 2007, we repaid the entire $5.3 million in principal and related
accrued interest due to Toucan Partners pursuant to the convertible notes.
63
Conversion of Preferred Stock and Related Matters
On June 1, 2007, we issued to Toucan Capital a Toucan Capital Series A-1 Warrant in exchange
for the cancellation of all previously issued warrants to purchase Series A-1 Preferred Stock (or,
at the election of Toucan Capital, any other equity or debt security of the Company) held by Toucan
Capital. The new Toucan Capital Series A-1 Warrant is exercisable for 6,471,333 shares of Series
A-1 Preferred Stock plus shares of Series A-1 Preferred Stock attributable to accrued dividends on
the shares of Series A-1 Preferred Stock held by Toucan Capital, (with each such Series A-1
Preferred Share convertible into 2.67 shares of common stock at $0.60 per share) as compared to the
3,062,500 shares of Series A-1 Preferred Stock (with each such Series A-1 Preferred Share
convertible into 2.67 shares of common stock at $0.60 per share) that were previously issuable to
Toucan Capital upon exercise of the warrants being cancelled.
Also on June 1, 2007, we and Toucan Capital amended Toucan Capitals Series A Warrant to
increase the number of shares of Series A Preferred Stock that are issuable upon exercise of the
warrant to 32,500,000 shares of Series A Preferred Stock (plus shares of Series A Preferred Stock
attributable to accrued dividends on the shares of Series A Preferred Stock held by Toucan Capital)
from 13,000,000 shares of Series A Preferred Stock.
In connection with the modifications of the Series A and Series A-1 Preferred Stock warrants,
we recognized reductions in earnings applicable to common stockholders in June 2007 of $2.3 million
and $16.4 million, respectively. The fair value of the warrant modifications were determined using
the Black-Scholes option pricing model with the following assumptions: expected dividend yield of
0%, risk-free interest rate of 5.0% volatility of 398%, and a contractual life of seven years.
On June 15, 2007, we, Toucan Capital, and Toucan Partners entered into a Conversion Agreement
which became effective on June 22, 2007 upon the admission of the Companys common stock to trade
on AIM (Admission).
Pursuant to the terms of the Conversion Agreement (i) Toucan Capital agreed to convert and has
converted all of its shares of the Companys Series A Preferred Stock and Series A-1 Preferred
Stock (in each case, excluding any accrued and unpaid dividends) into common stock and agreed to
eliminate a number of rights, preferences and protections associated with the Series A Preferred
Stock and Series A-1 Preferred Stock, including the liquidation preference entitling Toucan Capital
to certain substantial cash payments and (ii) Toucan Partners agreed to eliminate all of its
existing rights to receive Series A-1 Preferred Stock under certain notes and warrants (and
thereafter to receive shares of common stock rather than shares of Series A-1 Preferred Stock), and
the rights, preferences and protections associated with the Series A-1 Preferred Stock, including
the liquidation preference that would entitle Toucan Partners to certain substantial cash payments.
In return for these agreements, we issued to Toucan Capital and Toucan Partners 4,287,851 and
2,572,710 shares of common stock, respectively. In connection with the issuance of these shares, we
recognized a further reduction of earnings applicable to common stockholders of $12.3 million in
June 2007.
Under the terms of the Conversion Agreement (i) the Toucan Capital Series A Warrant is
exercisable for 2,166,667 shares of common stock rather than shares of Series A Preferred Stock
(plus shares of common stock, rather than shares of Series A Preferred Stock, attributable to
accrued dividends on the shares of Series A Preferred Stock previously held by Toucan Capital that
were converted into common stock upon Admission, subject to the further provisions of the
Conversion Agreement as described below) and (ii) the Toucan Capital Series A-1 Warrant became
exercisable for an aggregate of 17,256,888 shares of common stock rather than shares of Series A-1
Preferred Stock (plus shares of common stock, rather than shares of Series A-1 Preferred Stock,
attributable to accrued dividends on the shares of Series A-1 Preferred Stock previously held by
Toucan Capital that were converted into common stock upon Admission), subject to further provisions
of the Conversion Agreement as described below.
As noted above, the 32,500,000 shares of Series A Preferred Stock held by Toucan Capital
converted, in accordance with their terms, into 2,166,667 shares of common stock and the 4,816,863
shares of Series A-1 Preferred Stock held by Toucan Capital converted, in accordance with their
terms, into 12,844,968 shares of common stock.
Under the terms of the Conversion Agreement, Toucan Capital also agreed to temporarily defer
receipt of the accrued and unpaid dividends on its shares of Series A Preferred Stock and Series
A-1 Preferred Stock of an amount equal to $334,340 and $917,451, respectively, until not later than
September 30, 2007. In September 2007, we paid these dividends in full to Toucan Capital.
64
As a result of the financings described above, as of April 21, 2008, Toucan Capital held:
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an aggregate of 19,299,486 shares of common stock;
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warrants to purchase 14,150,732 shares of common stock at an exercise price of $0.60 per
share; and
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warrants to purchase 7,884,357 shares of common stock at an exercise price of $0.15 per
share.
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As a result of the financings described above, as of April 21, 2008, Toucan Partners held:
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an aggregate of 2,572,710 shares of common stock; and
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warrants to purchase 8,832,541 shares of common stock at an exercise price of $0.60 per
share.
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The investments made by Toucan Capital and Toucan Partners were made pursuant to the terms and
conditions of a Recapitalization Agreement originally entered into on April 26, 2004 with Toucan
Capital. The Recapitalization Agreement, as amended, originally contemplated the investment of up
to $40 million through the issuance of new securities to Toucan Capital and a syndicate of other
investors to be determined.
We and Toucan Capital amended the Recapitalization Agreement in conjunction with each
successive loan agreement. The amendments generally (i) updated certain representations and
warranties of the parties made in the Recapitalization Agreement, and (ii) made certain technical
changes in the Recapitalization Agreement in order to facilitate the bridge loans described
therein.
Through June 22, 2007, we accrued and paid certain legal and other administrative costs on
Toucan Capitals behalf pursuant to the Recapitalization Agreement. Subsequent to June 22, 2007,
Toucan Capital has incurred further costs on our behalf, primarily related to travel expenses and
fees incurred in connection with efforts to investigate and establish DCVax® businesses in other
locations overseas. In addition, effective July 1, 2007, we commenced accruing rent expense
related to the sublease for our Bethesda, Maryland office space from Toucan Capital Corporation.
During the year ended December 31, 2007, we recognized approximately $1.0 million of general and
administrative costs related to the Recapitalization Agreement, rent expense and costs incurred by
Toucan Capital on our behalf. Approximately $175,000 of these costs relate to activities which took
place prior to 2007. During the year ended December 31, 2006, we recognized approximately $1.3
million of general and administrative costs related to the Recapitalization Agreement. Pursuant to
the terms of the Conversion Agreement, the Recapitalization Agreement was terminated on June 22,
2007.
As of April 21 2008, Toucan Capital, including the holdings of Toucan Partners, beneficially
owned 21,872,196 shares of our capital stock, representing approximately 51.7% of our outstanding
common stock.
Cognate
On July 30, 2004, we entered into a service agreement with Cognate, a contract manufacturing
and services organization in which Toucan Capital has a majority interest. In addition, two of the
principals of Toucan Capital are members of Cognates board of directors and, on May 17, 2007, the
managing director of Toucan Capital, Linda Powers, was appointed to serve as our director and to
serve as the non-executive Chairperson of our Board of Directors. Under the service agreement, we
agreed to utilize Cognates services for an initial two-year period, related primarily to
manufacturing DCVax® product candidates, regulatory advice, research and development preclinical
activities and managing clinical trials. The agreement expired on July 30, 2006; however, we
continued to utilize Cognates services under the same terms as set forth in the expired agreement.
On May 17, 2007, we entered into a new services agreement with Cognate pursuant to which Cognate
will provide certain consulting and, when needed, manufacturing services to us for our DCVax®-Brain
Phase II clinical trial. Under the terms of the new contract, we paid a non-refundable contract
initiation fee of $250,000 and committed to pay budgeted monthly service fees of $400,000, subject
to quarterly true-ups, and monthly facility fees of $150,000. We may terminate this agreement with
180 days notice and payment of all reasonable wind-up costs and Cognate may terminate the contract
in the event that the brain cancer clinical trial fails to complete enrollment by July 1, 2009.
However, if such termination by the Company occurs at any time prior to the earlier of the
submission of an FDA biological license application/new drug application on the Companys brain
cancer clinical trial or July 1, 2010 or, such termination by Cognate results from failure of the
brain cancer clinical trial to complete patient enrollment by July 1, 2009, the Company is
obligated to make an additional termination fee payment to Cognate equal to $2 million.
65
During the years ending December 31, 2005, 2006 and 2007, respectively, we recognized approximately
$3.5 million, $2.4 million and $5.8 million of research and development costs related to this
service agreement. As of December 31, 2006 and 2007, we owed Cognate approximately $2.2 million and
$0, respectively.
Review, Approval or Ratification of Transactions with Related Persons
Our policy with respect to any transaction between the Company and any related person
requiring disclosure under Item 404(a) of Regulation S-K, is that such transaction is consummated
only if the Audit Committee approves such transaction or if the transaction involves compensation
approved or ratified by the Compensation Committee. The Board of Directors has not adopted a
written policy reflecting the policy and procedures described above; it intends to do so, but may
not.
SECURITY OWNERSHIP OF BENEFICIAL OWNERS AND SELLING STOCKHOLDERS
Security Ownership of Beneficial Owners
The following table presents information regarding the beneficial ownership of our common stock as
of April 21, 2008 by:
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each person, or group of affiliated persons, who is known by us to own beneficially 5% or
more of any class of our equity securities;
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our directors;
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each of our named executive officers, as defined in Item 402(a)(3) of Regulation S-K; and
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our directors and executive officers as a group.
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The applicable percentages of ownership are based on an aggregate of
42,346,839 shares of common
stock issued and outstanding on April 21, 2008. In computing the number of shares of common stock
beneficially owned by a person and the percentage ownership of that person, we deemed shares of
common stock subject to options, warrants, convertible preferred stock or convertible notes held by
that person that are currently exercisable or exercisable within 60 days of April 21, 2008.
We have determined beneficial ownership in accordance with the rules of the SEC. Except as
indicated by the footnotes below, we believe, based on the information furnished to us, that the
persons and the entities named in the table have sole voting and investment power with respect to
all shares of common stock that they beneficially own, subject to applicable community property
laws.
66
Except as otherwise noted, the address of the individuals in the following table below is c/o
Northwest Biotherapeutics, Inc., 7600 Wisconsin Avenue, Suite 750, Bethesda, MD 20814.
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Number of Shares
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Beneficially
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Percentage
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Name of Beneficial Owner
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Owned
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(1)
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Officers and Directors
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Alton L. Boynton, Ph.D.(2)
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1,007,835
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2.3
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Anthony P. Deasey
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James D. Johnston
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1,667
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Marnix L. Bosch, Ph.D., M.B.A.(3)
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265,284
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0.6
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Linda F. Powers (4)
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52,739,826
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72.0
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R. Steve Harris
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All executive officers and directors
as a group (4 persons)(5)
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1,273,119
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2.9
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5% Security Holders
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|
|
Toucan Capital Fund II, L.P.(6)
|
|
|
41,334,575
|
|
|
|
64.2
|
|
7600 Wisconsin Avenue, Suite 700,
Bethesda, MD 20814
Toucan Partners, LLC (7)
|
|
|
|
|
|
|
|
|
Toucan Partners, LLC (7)
|
|
|
11,405,251
|
|
|
|
22.3
|
|
7600 Wisconsin Avenue, Suite 700,
Bethesda, MD 20814
|
|
|
|
|
|
|
|
|
Al Rajhi Holdings
|
|
|
4,500,000
|
|
|
|
10.6
|
|
Rue Maurice
3 1204
|
|
|
|
|
|
|
|
|
Geneve Switzerland
|
|
|
|
|
|
|
|
|
IS Partners Investment Solutions AG
|
|
|
2,302,632
|
|
|
|
5.4
|
|
Helium Special Situations Fund
|
|
|
|
|
|
|
|
|
Limmatquai 2 8001 Zurich
|
|
|
|
|
|
|
|
|
PO Box 463 8024 Zurich Switzerland
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
|
Percentage represents beneficial ownership percentage of common stock calculated in
accordance with SEC rules and does not equate to voting percentages.
|
|
(2)
|
|
Includes 827,736 shares of common stock issuable upon exercise of options that are
exercisable within 60 days of April 21, 2008.
|
|
(3)
|
|
Includes 199,857 shares of common stock issuable upon exercise of options that are
exercisable within 60 days of April 21, 2008.
|
|
(4)
|
|
Includes (i) 19,299,486 shares of common stock held by Toucan Capital; (ii) 22,035,089 shares
of common stock currently issuable upon exercise of warrants that are exercisable within 60
days of April 21, 2008 held by Toucan Capital; (iii) 8,832,541 shares of common stock
currently issuable upon exercise of warrants that are exercisable within 60 days of April 21,
2008 held by Toucan Partners, and (iv) 2,572,710 shares of common stock held by Toucan
Partners. Ms. Powers is a managing member of Toucan Management, LLC, which is the manager of
Toucan Capital, and is a managing member of Toucan Partners. Ms. Powers disclaims beneficial
ownership as to all such shares of common stock.
|
|
(5)
|
|
Includes 1,025,926 shares issuable to officers and directors upon exercise of options that
are exercisable within 60 days of April 21, 2008. Excludes 52,739,826 shares of common stock
as to which Ms. Powers disclaims beneficial ownership. See Note 4 above.
|
|
(6)
|
|
Includes 22,035,089 shares of common stock currently issuable upon exercise of warrants that
are exercisable within 60 days of April 21, 2008 held by Toucan Capital.
|
|
(7)
|
|
Includes 8,832,541 shares of common stock currently issuable upon exercise of warrants that
are exercisable within 60 days of April 21, 2008 held by Toucan Partners.
|
67
Selling Stockholders
The beneficial ownership amounts requested in the following table include shares of common stock
certain selling stockholders will receive upon exercise of warrants for cash. None of the selling
stockholders has had any position, office or other material relationship with us within the past
three years other than as a result of the ownership of our shares or other securities. Because the
selling stockholders may offer some or all of their shares, no definitive estimate as to the number
of shares that will be held by the selling stockholders after such offering can be provided and the
following table has been prepared on the assumption that all shares of common stock offered hereby
will be sold.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares of Common Stock
|
|
|
|
|
|
Shares of Common Stock
|
|
|
Beneficially Owned
|
|
Shares
|
|
Beneficially Owned
|
|
|
Before the Offering(1)
|
|
Being
|
|
After the Offering(3)
|
Beneficial Owner
|
|
Number
|
|
Percentage
|
|
Offered(2)
|
|
Number
|
|
Percentage
|
Bluegrass Growth Fund, L.P.(4)
|
|
|
59,523
|
|
|
*
|
|
|
59,523
|
|
|
|
0
|
|
|
*
|
Andrew M. Blum(5)
|
|
|
1,191
|
|
|
*
|
|
|
1,191
|
|
|
|
0
|
|
|
*
|
Bristol Investment Fund, Ltd(6)
|
|
|
35,714
|
|
|
*
|
|
|
35,714
|
|
|
|
0
|
|
|
*
|
C.E. Unterberg Towbin Capital
Partners I LP(7)
|
|
|
119,166
|
|
|
*
|
|
|
119,166
|
|
|
|
0
|
|
|
*
|
Cranshire Capital, LP(8)
|
|
|
59,523
|
|
|
*
|
|
|
59,523
|
|
|
|
0
|
|
|
*
|
John H. Gutfreund(9)
|
|
|
11,916
|
|
|
*
|
|
|
11,916
|
|
|
|
0
|
|
|
*
|
Smithfield Fiduciary LLC(10)
|
|
|
17,998
|
|
|
*
|
|
|
17,998
|
|
|
|
0
|
|
|
*
|
Iroquois Masterfund Ltd(11)
|
|
|
119,047
|
|
|
*
|
|
|
119,047
|
|
|
|
0
|
|
|
*
|
Joseph Reda(12)
|
|
|
8,333
|
|
|
*
|
|
|
8,333
|
|
|
|
0
|
|
|
*
|
Stoc*Doc Partners, L.P.(13)
|
|
|
8,666
|
|
|
*
|
|
|
8,666
|
|
|
|
0
|
|
|
*
|
Ellen U Celli Emily U Satloff
TTEE T.I. Unterberg(14)
|
|
|
11,916
|
|
|
*
|
|
|
11,916
|
|
|
|
0
|
|
|
*
|
Declaration of Trust by Thomas
I. Unterberg(15)
|
|
|
23,833
|
|
|
*
|
|
|
23,833
|
|
|
|
0
|
|
|
*
|
68
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares of Common Stock
|
|
|
|
|
|
Shares of Common Stock
|
|
|
Beneficially Owned
|
|
Shares
|
|
Beneficially Owned
|
|
|
Before the Offering(1)
|
|
Being
|
|
After the Offering(3)
|
Beneficial Owner
|
|
Number
|
|
Percentage
|
|
Offered(2)
|
|
Number
|
|
Percentage
|
Thomas I. Unterberg(16)
|
|
|
47,666
|
|
|
*
|
|
|
47,666
|
|
|
|
0
|
|
|
*
|
Thomas I. Unterberg TTEE
Ellen U. Celli Family
Trust /25/93(17)
|
|
|
23,833
|
|
|
*
|
|
|
23,833
|
|
|
|
0
|
|
|
*
|
Ellen U. Celli(18)
|
|
|
23,833
|
|
|
*
|
|
|
23,833
|
|
|
|
0
|
|
|
*
|
Emily Satloff(19)
|
|
|
11,916
|
|
|
*
|
|
|
11,916
|
|
|
|
0
|
|
|
*
|
Marjorie & Clarence
Unterberg Foundation(20)
|
|
|
35,733
|
|
|
*
|
|
|
35,733
|
|
|
|
0
|
|
|
*
|
NFS/ FINTC IRA FBO Thomas
I. Unterberg(21)
|
|
|
23,833
|
|
|
*
|
|
|
23,833
|
|
|
|
0
|
|
|
*
|
Thomas I. Unterberg TTEE.
Emily U. Satloff Family
Trust U/ A 03/25/93(22)
|
|
|
23,833
|
|
|
*
|
|
|
23,833
|
|
|
|
0
|
|
|
*
|
Ann Unterberg(23)
|
|
|
11,916
|
|
|
*
|
|
|
11,916
|
|
|
|
0
|
|
|
*
|
|
|
|
*
|
|
Less than 1%
|
|
(1)
|
|
Calculated based on Rule 13d-3(d)(i) under the Exchange Act. In calculating this amount for
each selling stockholder, we treated as outstanding the number of shares of common stock
issuable upon exercise for cash of that selling stockholders warrants but we did not assume
exercise of any other selling stockholders warrants.
|
|
(2)
|
|
In calculating this amount for each selling stockholder, we included the number of shares of
common stock issuable upon exercise for cash of that selling stockholders warrants.
|
|
(3)
|
|
Assumes sale of all shares offered by the selling stockholder.
|
|
(4)
|
|
Includes 59,523 shares of common stock currently issuable upon the exercise of warrants.
|
|
(5)
|
|
Includes 1,191 shares of common stock currently issuable upon the exercise of warrants.
|
|
(6)
|
|
Includes 35,714 shares of common stock currently issuable upon the exercise of warrants.
|
|
(7)
|
|
Includes 119,166 shares of common stock currently issuable upon the exercise of warrants.
|
|
(8)
|
|
Includes 59,523 shares of common stock currently issuable upon the exercise of warrants.
|
|
(9)
|
|
Includes 11,916 shares of common stock currently issuable upon the exercise of warrants.
|
|
(10)
|
|
Includes 17,998 shares of common stock currently issuable upon the exercise of warrants.
|
|
(11)
|
|
Includes 119,047 shares of common stock currently issuable upon the exercise of warrants.
|
|
(12)
|
|
Includes 8,333 shares of common stock currently issuable upon the exercise of warrants.
|
|
(13)
|
|
Includes 6,666 shares of common stock currently issuable upon the exercise of warrants.
|
|
(14)
|
|
Includes 11,916 shares of common stock currently issuable upon the exercise of warrants.
|
69
|
|
|
(15)
|
|
Includes 23,833 shares of common stock currently issuable upon the exercise of warrants.
|
|
(16)
|
|
Includes 47,666 shares of common stock currently issuable upon the exercise of warrants.
|
|
(17)
|
|
Includes 23,833 shares of common stock currently issuable upon the exercise of warrants.
|
|
(18)
|
|
Includes 23,833 shares of common stock currently issuable upon the exercise of warrants.
|
|
(19)
|
|
Includes 11,916 shares of common stock currently issuable upon the exercise of warrants.
|
|
(20)
|
|
Includes 35,733 shares of common stock currently issuable upon the exercise of warrants.
|
|
(21)
|
|
Includes 23,833 shares of common stock currently issuable upon the exercise of warrants.
|
|
(22)
|
|
Includes 23,833 shares of common stock currently issuable upon the exercise of warrants.
|
|
(23)
|
|
Includes 11,916 shares of common stock currently issuable upon the exercise of warrants.
|
DESCRIPTION OF CAPITAL STOCK
As of the date of this prospectus, we are authorized to issue 100,000,000 shares of common
stock par value $0.001 per share, and 20,000,000 shares of preferred stock, par value $0.001 per
share.
As of April 21, 2008, we had
42,346,839 shares of common stock issued and outstanding, and had
reserved an additional:
|
|
|
31,702,034 shares of common stock for issuance upon exercise of outstanding warrants,
|
|
|
|
|
5,480,267 shares of common stock for issuance upon exercise of outstanding stock options,
and
|
|
|
|
|
555,538 shares of common stock for issuance under our 2007 Stock Option Plan.
|
As of April 21, 2008, we did not have any shares of preferred stock outstanding.
Common Stock
Voting Rights.
Each holder of shares of our common stock is entitled to one vote for each
share of such common stock held by such holder. Under our Bylaws, the holders of a majority of the
voting power of our issued and outstanding stock entitled to vote thereat, present in person or
represented by proxy, shall constitute a quorum for the transaction of business at all meetings of
stockholders, except as otherwise provided by statute or by our certificate of incorporation. When
a quorum is present at any meeting, the vote of the holders of a majority of the voting power of
our issued and outstanding stock entitled to vote thereon, present in person or represented by
proxy, shall decide any questions brought before such meeting, unless the question is one upon
which by express provision of statute or of the certificate of incorporation or of the Bylaws, a
different vote is required, in which case such express provision shall govern and control the
decision of such question.
Dividends.
Subject to the dividend rights of the outstanding shares of issued and outstanding
preferred stock, if any, holders of common stock are entitled to receive dividends, when, as and if
declared by the Board of Directors out of assets lawfully available for such purposes. No dividends
will be paid on any shares of common stock unless the same dividend is paid on all shares of common
stock outstanding at the time of such payment.
Rights upon Liquidation, Dissolution or Winding Up.
In the event of any distribution of assets
upon liquidation, dissolution or winding up of our affairs, holders of common stock will be
entitled to share ratably and equally all of our assets and funds remaining after payment to the
holders of our preferred stock, if any, of the specific amounts which they are entitled to receive
upon such liquidation, dissolution or winding up as herein provided.
70
Other Rights.
Holders of common stock have no subscription, redemption or conversion rights,
nor do they have any preemptive or other rights to acquire or subscribe for additional, unissued or
treasury shares, except as expressly provided for in our stockholder rights plan. Accordingly, if
we were to elect to sell additional shares of common stock, persons acquiring common stock in this
offering would have no right to purchase additional shares and, as a result, their percentage
equity interest in the Company would be reduced.
Registration Rights
In addition to the rights of the selling stockholders to require us to file the registration
statement of which this prospectus is a part for the purpose of registering the resale of the
shares offered hereby, holders of approximately 52.8 million shares of our common stock (issued or
issuable upon exercise of warrants or conversion of promissory notes), which shares we refer to as
registrable securities, have the following registration rights with respect to those shares:
Demand Registration Rights.
The holders of 20% or more of the registrable securities, or
their transferees, may require us on not more than two occasions in a twelve month period
(exclusive of registration on Form S-3), to file a registration statement under the Securities
Act with respect to their shares of common stock, provided that the anticipated aggregate
offering price to the public of at least $2.0 million. These registration rights are subject to
specified conditions and limitations. Under the terms of the registration pursuant to which these
rights are granted, we will be required to register for resale these shares if we receive a
written request from holders of at least a majority of all such shares then outstanding.
Piggyback Registration Rights.
If we propose to register any of our securities under the
Securities Act either for our own account or for the account of other stockholders, the holders
of the registrable securities will be entitled to notice of the registration and will be entitled
to include their shares of common stock in the registration statement. These registration rights
are subject to specified conditions and limitations, including the right of the underwriters to
limit the number of shares included in any such registration under some circumstances. The
holders of the registrable securities have waived their right to have their shares included in
this offering.
Registration on
Form S-3
.
The holders of the registrable securities are entitled, upon
written request from holders of registrable securities, to have such shares registered by us on a
Form S-3 registration statement at our expense provided that such requested registration has an
anticipated aggregate offering price to the public of at least $1.0 million. These registration
rights are subject to specified conditions and limitations.
Expenses of Registration.
We will pay all expenses relating to any demand, piggyback or Form
S-3 registrations, other than underwriting discounts and commissions.
Certain Provisions of Delaware Law and Our Certificate of Incorporation and Bylaws
A number of provisions of our Certificate of Incorporation and Bylaws concern matters of
corporate governance and the rights of stockholders. Certain of these provisions, as well as the
ability of our Board of Directors to issue shares of preferred stock and to set the voting rights,
preferences and other terms thereof, may be deemed to have an anti-takeover effect and may
discourage takeover attempts not first approved by the Board of Directors (including takeovers
which certain stockholders may deemed to be in their best interests). To the extent takeover
attempts are discouraged, temporary fluctuations in the market price of the common stock, which may
result from actual or rumored takeover attempts, may be inhibited. These provisions, together with
the ability of our Board to issue preferred stock without further stockholder action, also could
delay or frustrate the removal of incumbent directors or the assumption of control by stockholders,
even if such removal or assumption would be beneficial to stockholders. These provisions also could
discourage or make more difficult a merger, tender offer or proxy contests, even if they could be
favorable to the interests of stockholders, and could potentially depress the market price of the
common stock. The Board of Directors believes these provisions are appropriate to protect the
interests of the Company and all of its stockholders.
Special Meetings of Stockholders.
A special meeting of stockholders may be called at any time
by the Board of Directors or the Chairman of the Board, if one shall have been elected, or the
Chief Executive Officer. Except as otherwise provided by applicable law, or the Certificate of
Incorporation or Bylaws, stockholders are not entitled to call a special meeting.
71
Number of Directors; Filling Vacancies.
Our Certificate of Incorporation and Bylaws provide
that the number of directors constituting the board of directors will be determined by the
affirmative vote of the entire Board of Directors (the current number of directors constituting the
full Board is five). Any vacancy occurring on the Board of Directors, including any vacancy created
by reason of an increase in the number of directors, may be filled for the unexpired term by the
concurring vote of a majority of the directors then in office, whether or not a quorum, or by the
sole remaining director. Each director so elected shall hold office for the remainder of the full
term of the class of directors in which the new directorship was created or the vacancy occurred
and until such directors successor has been elected and qualified.
Classification of Directors.
Our Bylaws provide that the directors shall be classified in
respect to the time for which they shall severally hold office, by dividing them into three
classes. The number of directors in each class must be as nearly equal as possible. At each annual
election, any vacancy in any class of directors may be filled and successors to the class of
directors whose terms shall expire that year are elected to hold office for a term of three years,
so that the term of office of one class of directors shall expire in each year. In the event the
number of directors is increased, election may be made to a class of directors with terms expiring
in three years or less in order to maintain proportionate equality between the classes. Any
decrease in the number of directors is effective at the time of the next succeeding annual meeting
of stockholders unless there are vacancies in the Board of Directors, in which case such decrease
may become effective at any time prior to the next succeeding annual meeting to the extent of the
number of such vacancies. Each director holds office until the expiration of the term for which he
or she is elected and until his or her successor has been elected and qualified, or until his or
her prior resignation or removal.
Amendments to Bylaws.
Our Bylaws provide that they may be amended or repealed or new bylaws
may be adopted by action of the affirmative vote of 66 2/3% of the stockholders entitled to vote
thereon at any annual or special meeting of stockholders or by action of the Board of Directors at
a regular or special meeting thereof.
Section 203 of the DGCL.
We are subject to Section 203 of the DGCL. Under this provision, we
may not engage in any business combination with any interested stockholder for a period of three
years following the date the stockholder became an interested stockholder, unless:
|
|
|
prior to such time our Board of Directors approved either the business combination or the
transaction which resulted in the stockholder becoming an interested stockholder;
|
|
|
|
|
upon consummation of the transaction which resulted in the stockholder becoming an
interested stockholder, the interested stockholder owned at least 85% of our voting stock
outstanding at the time the transaction commenced, excluding for purposes of determining the
voting stock outstanding (but not the outstanding voting stock owned by the interested
stockholder) those shares owned (i) by persons who are directors and also officers and (ii)
employee stock plans in which employee participants do not have the right to determine
confidentially whether shares held subject to the plan will be tendered in a tender or
exchange offer; or
|
|
|
|
|
at or subsequent to such time the business combination is approved by the Board of
Directors and authorized at an annual or special meeting of stockholders, and not by written
consent, by the affirmative vote of at least 66 2/3% of the outstanding voting stock which
is not owned by the interested stockholder.
|
Section 203 defines business combination to include the following:
|
|
|
any sale, transfer, pledge or other disposition of 10% or more of the assets of the
corporation involving the interested stockholder;
|
|
|
|
|
subject to some exceptions, any transaction that results in the issuance or transfer by
the corporation of any stock of the corporation to the interested stockholder;
|
|
|
|
|
any transaction involving the corporation that has the effect of increasing the
proportionate share of the stock of any class or series of the corporation beneficially
owned by the interested stockholder; or
|
72
|
|
|
the receipt by the interested stockholder of the benefit of any loans, advances,
guarantees, pledges or other financial benefits provided by or through the corporation.
|
In general, Section 203 defines an interested stockholder as any entity or person
beneficially owning 15% or more of the outstanding voting stock of the corporation and any entity
or person affiliated with or controlling or controlled by the entity or person.
Transfer Agent
The transfer agent for our common stock is Bank of New York Mellon Shareowner Services.
SHARES ELIGIBLE FOR FUTURE SALE
Future market sales of shares or the availability of shares for sale may decrease the market
price of our common stock prevailing from time to time. As described below, only a portion of our
outstanding shares of common stock will be available for sale shortly after this offering due to
legal restrictions on resale. Nevertheless, sales of substantial amounts of common stock in the
public market after these restrictions lapse, or the perception that such sales could occur, could
adversely affect the market price of the common stock and could impair our future ability to raise
capital through the sale of our equity securities.
Based on 42,346,839 shares of common stock outstanding as of April 21, 2008, there would be a
total of 79,579,896 shares of common stock outstanding upon the full conversion and exercise of all
currently outstanding options and warrants. Of these outstanding shares, upon the effectiveness of
the registration statement of which this prospectus is a part, 3,596,209 shares will be freely
tradable, except that any shares held by our affiliates, as that term is defined under Rule 144
under the Securities Act, may only be sold in compliance with the Rule 144 limitations described
below. A further 15,789,473 shares of our common stock are tradable only on AIM. The remainder
(substantially all of which are beneficially owned by Toucan Capital and Toucan Partners) would be
eligible for resale in accordance with the resale provisions of Rule 144 or upon our registration
of such shares for resale. However, in connection with the admission of our common stock to trading
on AIM on June 22, 2007 (the Admission), each of the directors of the Company, Toucan Capital and
Toucan Partners agreed not to dispose of any common stock (or any interest) held by them (subject
to certain limited exemptions) for a period of 12 months following Admission (the Lock-up).
Rule 144
In general, under Rule 144 under the Securities Act, a person, or group of persons whose
shares are required to be aggregated, who has beneficially owned shares of our common stock for at
least six months and who is not an affiliate of ours at any time during the 90 days preceding a
sale, will be entitled to sell such shares without limitation, provided that we continue to comply
with our Exchange Act reporting obligations for a period of one year after the seller first
acquired such shares. Sales by affiliates after the six-month holding period described above are
limited in any three-month period to a number of shares that does not exceed 1% of the number of
shares of our common stock then outstanding, which equals approximately 423,000 shares based on the
number of shares of common stock outstanding as of April 21, 2008. In addition, such sales by
affiliates are subject to the manner of sale provisions and other requirements under Rule 144.
Rule 701
Rule 701, as currently in effect, permits resales of shares in reliance upon Rule 144 but
without compliance with certain restrictions of Rule 144, including the holding period requirement.
Most of our employees, officers, directors or consultants who purchased shares under a written
compensatory plan or contract may be entitled to rely on the resale provisions of Rule 701.
Registration Rights
Toucan Capital and Toucan Partners, which as of April 21, 2008 collectively owned an aggregate
of approximately 21.9 million shares of our common stock, may acquire an additional approximately
30.9 million shares upon exercise of warrants with exercise prices ranging from $0.15 per share to
$0.60 per share, or their transferees, are entitled to rights with respect to the registration of
their shares under the Securities Act. Registration of their shares under the Securities Act would
result in the shares becoming freely
tradable without restriction under the Securities Act, except for shares purchased by
affiliates. See Description of Capital Stock Registration Rights.
73
Stock Options
We have filed with the SEC registration statements under the Securities Act covering the
shares of common stock reserved for issuance under our stock option plans and employee stock
purchase plan. These registration statements are effective. Accordingly, the shares registered
under the registration statements are, subject to Rule 144 volume limitations, applicable to
affiliates and the restrictions of the Lock-up described above, available for sale in the open
market.
PLAN OF DISTRIBUTION
The selling stockholders, which as used herein includes donees, pledgees, transferees or other
successors-in-interest selling shares of common stock or interests in shares of common stock
received after the date of this prospectus from a selling stockholder as a gift, pledge,
partnership distribution or other transfer, may, from time to time, sell, transfer or otherwise
dispose of any or all of their shares of common stock or interests in shares of common stock on any
stock exchange, market or trading facility on which the shares are traded or in private
transactions. These dispositions may be at fixed prices, at prevailing market prices at the time of
sale, at prices related to the prevailing market price, at varying prices determined at the time of
sale, or at negotiated prices.
The selling stockholders may use any one or more of the following methods when disposing of
shares or interests therein:
|
|
|
ordinary brokerage transactions and transactions in which the broker-dealer solicits
purchasers;
|
|
|
|
|
block trades in which the broker-dealer will attempt to sell the shares as agent, but may
position and resell a portion of the block as principal to facilitate the transaction;
|
|
|
|
|
purchases by a broker-dealer as principal and resale by the broker-dealer for its
account;
|
|
|
|
|
an exchange distribution in accordance with the rules of the applicable exchange;
|
|
|
|
|
privately negotiated transactions;
|
|
|
|
|
short sales effected after the date the registration statement of which this prospectus
is a part is declared effective by the SEC;
|
|
|
|
|
through the writing or settlement of options or other hedging transactions, whether
through an options exchange or otherwise;
|
|
|
|
|
broker-dealers may agree with the selling stockholders to sell a specified number of such
shares at a stipulated price per share;
|
|
|
|
|
a combination of any such methods of sale; and
|
|
|
|
|
any other method permitted pursuant to applicable law.
|
The selling stockholders may, from time to time, pledge or grant a security interest in some
or all of the shares of common stock owned by them and, if they default in the performance of their
secured obligations, the pledgees or secured parties may offer and sell the shares of common stock,
from time to time, under this prospectus, or under an amendment to this prospectus under Rule
424(b)(3) or other applicable provision of the Securities Act amending the list of selling
stockholders to include the pledgee, transferee or other successors in interest as selling
stockholders under this prospectus. The selling stockholders also may transfer the shares of common
stock in other circumstances, in which case the transferees, pledgees or other successors in
interest will be the selling beneficial owners for purposes of this prospectus.
In connection with the sale of our common stock or interests therein, the selling stockholders
may enter into hedging transactions with broker-dealers or other financial institutions, which may
in turn engage in short sales of the common stock in the course of hedging the positions they
assume. The selling stockholders may also sell shares of our common stock short and deliver these
securities to close out their short positions, or loan or pledge the common stock to
broker-dealers that in turn may sell these securities. The selling stockholders may also enter into
option or other transactions with broker-dealers or other financial institutions or the creation of
one or more derivative securities which require the delivery to such broker-dealer or other
financial institution of shares offered by this prospectus, which shares such broker-dealer or
other financial institution may resell pursuant to this prospectus (as supplemented or amended to
reflect such transaction).
74
The aggregate proceeds to the selling stockholders from the sale of the common stock offered
by them will be the purchase price of the common stock less discounts or commissions, if any. Each
of the selling stockholders reserves the right to accept and, together with their agents from time
to time, to reject, in whole or in part, any proposed purchase of common stock to be made directly
or through agents. We will not receive any of the proceeds from this offering. Upon any exercise of
the warrants by payment of cash, however, we will receive the exercise price of the warrants.
The selling stockholders also may resell all or a portion of the shares in open market
transactions in reliance upon Rule 144 under the Securities Act, provided that they meet the
criteria and conform to the requirements of that rule.
The selling stockholders and any underwriters, broker-dealers or agents that participate in
the sale of the common stock or interests therein may be underwriters within the meaning of
Section 2(11) of the Securities Act. Any discounts, commissions, concessions or profits they earn
on any resale of the shares may be underwriting discounts and commissions under the Securities Act.
Selling stockholders who are underwriters within the meaning of Section 2(11) of the Securities
Act will be subject to the prospectus delivery requirements of the Securities Act.
To the extent required, the shares of our common stock to be sold, the names of the selling
stockholders, the respective purchase prices and public offering prices, the names of any agents,
dealer or underwriter, and any applicable commissions or discounts with respect to a particular
offer will be set forth in an accompanying prospectus supplement or, if appropriate, a
post-effective amendment to the registration statement that includes this prospectus.
In order to comply with the securities laws of some states, if applicable, the common stock
may be sold in these jurisdictions only through registered or licensed brokers or dealers. In
addition, in some states the common stock may not be sold unless it has been registered or
qualified for sale or an exemption from registration or qualification requirements is available and
is complied with.
We have advised the selling stockholders that the anti-manipulation rules of Regulation M
under the Exchange Act may apply to sales of shares in the market and to the activities of the
selling stockholders and their affiliates. In addition, we will make copies of this prospectus (as
it may be supplemented or amended from time to time) available to the selling stockholders for the
purpose of satisfying the prospectus delivery requirements of the Securities Act. The selling
stockholders may indemnify any broker-dealer that participates in transactions involving the sale
of the shares against certain liabilities, including liabilities arising under the Securities Act.
We have agreed to indemnify the selling stockholders against liabilities, including
liabilities under the Securities Act and state securities laws, relating to the registration of the
shares of common stock offered by this prospectus.
We have agreed with the selling stockholders to keep the registration statement, of which this
prospectus constitutes a part, effective until the earlier of (1) the second anniversary of the
effective date of the registration statement; (2) such time as all of the shares covered by this
prospectus have been disposed of pursuant to and in accordance with the registration statement or
(3) the date on which the shares may be sold pursuant to Rule 144(k) of the Securities Act.
All costs, expenses and fees in connection with this registration will be borne by us.
Brokerage commissions and similar seller expenses, if any, related to the sale of the shares will
be borne by the selling stockholders.
LEGAL MATTERS
The validity of the common stock offered by this prospectus will be passed upon for us by
Covington & Burling LLP, Washington, D.C.
75
EXPERTS
The consolidated financial statements of Northwest Biotherapeutics, Inc. as of December 31,
2007 and 2006 and for each of the years in the three year period ended December 31, 2007 and the
period from March 18, 1996 (inception) through December 31, 2007 have been included in this
prospectus and registration statement in reliance upon the report of Peterson Sullivan PLLC, a
registered independent public accounting firm, appearing elsewhere herein, and upon the authority
of said firm as experts in accounting and auditing.
The report of Peterson Sullivan PLLC covering the December 31, 2007 financial statements
contains an explanatory paragraph that states that the Company has experienced recurring losses
from operations since inception, net operating cash flow deficits, and has a deficit accumulated
during the development stage. These conditions raise substantial doubt about the Companys ability
to continue as a going concern. The financial statements do not include any adjustments that might
result from the outcome of this uncertainty.
WHERE YOU CAN FIND MORE INFORMATION
We have filed with the SEC a registration statement on Form S-1, of which this prospectus is a
part, under the Securities Act with respect to the common stock offered hereby. This prospectus
does not contain all of the information included in the registration statement. Statements in this
prospectus concerning the provisions of any document are not necessarily complete. You should refer
to the copies of the documents filed as exhibits to the registration statement or otherwise filed
by us with the SEC for a more complete understanding of the matter involved. Each statement
concerning these documents is qualified in its entirety by such reference.
We are subject to the informational requirements of the Exchange Act, and, accordingly, file
Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, proxy
statements and other information with the SEC. The SEC maintains a web site at http://www.sec.gov
that contains reports and information statements and other information regarding registrants that
file electronically with the SEC. You may read and copy the registration statement and the reports
and other information we file with the SEC at the SECs Public Reference Room at 100 F Street,
N.E., Washington, DC 20549. You may obtain information on the operation of the public reference
room by calling the SEC at 1-800-SEC-0330.
Our website address is
www.nwbio.com
. The information available on or through our
website is not part of this prospectus.
76
INDEX TO FINANCIAL STATEMENTS
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Page
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I FINANCIAL STATEMENTS
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Report of Peterson Sullivan, PLLC, Independent Registered Public Accounting Firm
|
|
|
F-2
|
|
Consolidated Balance Sheets as of December 31, 2006 and 2007
|
|
|
F-3
|
|
Consolidated Statements of Operations for each of the three years ended
December 31, 2007 and the period from March 18, 1996 (inception) to December
31, 2007
|
|
|
F-4
|
|
Consolidated Statements of Stockholders Equity (Deficit) and Comprehensive Loss
|
|
|
F-5
|
|
Consolidated Statements of Cash Flows for each of the three years ended
December 31, 2007 and the period from March 18, 1996 (inception) to December
31, 2007
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|
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F-6
|
|
Notes to Financial Statements
|
|
|
F-7
|
|
F-1
Part I Financial Information
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors
Northwest Biotherapeutics, Inc.
Bethesda, Maryland
We have audited the accompanying consolidated balance sheets of Northwest Biotherapeutics,
Inc. (a development stage company) as of December 31, 2007 and 2006, and the related consolidated
statements of operations, stockholders equity (deficit), and cash flows for each of the years in
the three-year period ended December 31, 2007, and for the period from March 18, 1996 (date of
inception) to December 31, 2007. These consolidated financial statements are the responsibility of
the Companys management. Our responsibility is to express an opinion on these consolidated
financial statements based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting
Oversight Board (United States). Those standards require that we plan and perform the audit to
obtain reasonable assurance about whether the financial statements are free of material
misstatement. The Company has determined that it is not required to have, nor were we engaged to
perform, an audit of its internal control over financial reporting. Our audit included
consideration of internal control over financial reporting as a basis for designing audit
procedures that are appropriate in the circumstances, but not for the purpose of expressing an
opinion on the effectiveness of the Companys internal control over financial reporting.
Accordingly, we express no such opinion. An audit includes examining, on a test basis, evidence
supporting the amounts and disclosures in the consolidated financial statements. An audit also
includes assessing the accounting principles used and significant estimates made by management, as
well as evaluating the overall financial statement presentation. We believe that our audits provide
a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all
material respects, the financial position of Northwest Biotherapeutics, Inc. (a development stage
company) as of December 31, 2007 and 2006, and the results of its operations and its cash flows for
each of the years in the three-year period ended December 31, 2007, and for the period from March
18, 1996 (date of inception) to December 31, 2007, in conformity with accounting principles
generally accepted in the United States.
The accompanying consolidated financial statements have been prepared assuming the Company
will continue as a going concern. As discussed in Note 2 to the consolidated financial statements,
the Company has experienced recurring losses from operations since inception, net operating cash
flow deficits, and has a deficit accumulated during the development stage. These conditions raise
substantial doubt about the Companys ability to continue as a going concern. Managements plans
regarding these matters are also described in Note 2. The consolidated financial statements do not
include any adjustments that might result from the outcome of this uncertainty.
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/s/ PETERSON SULLIVAN PLLC
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Peterson Sullivan PLLC
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April 7, 2008
Seattle, Washington
F-2
NORTHWEST BIOTHERAPEUTICS, INC.
(A Development Stage Company)
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
2006
|
|
|
2007
|
|
|
|
(In thousands)
|
|
ASSETS
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash
|
|
$
|
307
|
|
|
$
|
7,861
|
|
Accounts receivable
|
|
|
3
|
|
|
|
|
|
Prepaid expenses and other current assets
|
|
|
145
|
|
|
|
823
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
455
|
|
|
|
8,684
|
|
|
|
|
|
|
|
|
Property and equipment:
|
|
|
|
|
|
|
|
|
Laboratory equipment
|
|
|
14
|
|
|
|
29
|
|
Office furniture and other equipment
|
|
|
71
|
|
|
|
94
|
|
|
|
|
|
|
|
|
|
|
|
85
|
|
|
|
123
|
|
Less accumulated depreciation and amortization
|
|
|
(70
|
)
|
|
|
(104
|
)
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
|
15
|
|
|
|
19
|
|
Restricted cash
|
|
|
31
|
|
|
|
|
|
Deposit and other non-current assets
|
|
|
3
|
|
|
|
3
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
504
|
|
|
$
|
8,706
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Note payable to related parties, net
|
|
$
|
2,505
|
|
|
$
|
|
|
Current portion of capital lease obligations
|
|
|
2
|
|
|
|
|
|
Accounts payable
|
|
|
493
|
|
|
|
846
|
|
Accounts payable, related party
|
|
|
2,852
|
|
|
|
161
|
|
Accrued expenses
|
|
|
301
|
|
|
|
1,006
|
|
Accrued expense, related party
|
|
|
300
|
|
|
|
886
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
6,453
|
|
|
|
2,899
|
|
Stockholders equity (deficit):
|
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par value; 300,000,000
and 20,000,000 shares authorized at December 31,
2006 and 2007, respectively
Series A preferred stock, 50,000,000 and zero
designated at December 31, 2006 and 2007,
respectively and 32,500,000 and zero shares
issued and outstanding at December 31, 2006 and
2007, respectively
|
|
|
33
|
|
|
|
|
|
Series A-1 preferred stock, 10,000,000 and zero
designated at December 31, 2006 and 2007
respectively and 4,816,863 and zero shares
issued and outstanding at December 31, 2006 and
2007, respectively
|
|
|
5
|
|
|
|
|
|
Common stock, $0.001 par value; 800,000,000 and
100,000,000 shares authorized at December 31,
2006 and 2007, respectively and 4,349,419 and
42,346,085 shares issued and outstanding at
December 31, 2006 and 2007, respectively
|
|
|
65
|
|
|
|
42
|
|
Additional paid-in capital
|
|
|
78,033
|
|
|
|
148,064
|
|
Deficit accumulated during the development stage
|
|
|
(84,085
|
)
|
|
|
(142,295
|
)
|
Cumulative translation adjustment
|
|
|
|
|
|
|
(4
|
)
|
|
|
|
|
|
|
|
Total stockholders (deficit) equity
|
|
|
(5,949
|
)
|
|
|
5,807
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity
|
|
$
|
504
|
|
|
$
|
8,706
|
|
|
|
|
|
|
|
|
See accompanying notes to the consolidated financial statements.
F-3
NORTHWEST BIOTHERAPEUTICS, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 18, 1996
|
|
|
|
Year Ended December 31,
|
|
|
(Inception) to
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2005
|
|
|
2006
|
|
|
2007
|
|
|
2007
|
|
|
|
(In thousands, except per share data)
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research materials sales
|
|
$
|
38
|
|
|
$
|
80
|
|
|
$
|
10
|
|
|
$
|
540
|
|
Contract research and development from related parties
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,128
|
|
Research grants and other
|
|
|
86
|
|
|
|
|
|
|
|
|
|
|
|
1,061
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
124
|
|
|
|
80
|
|
|
|
10
|
|
|
|
2,729
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of research material sales
|
|
|
12
|
|
|
|
|
|
|
|
|
|
|
|
382
|
|
Research and development
|
|
|
4,469
|
|
|
|
3,777
|
|
|
|
8,778
|
|
|
|
44,622
|
|
General and administrative
|
|
|
2,005
|
|
|
|
2,273
|
|
|
|
7,171
|
|
|
|
40,138
|
|
Depreciation and amortization
|
|
|
63
|
|
|
|
37
|
|
|
|
19
|
|
|
|
2,322
|
|
Loss on facility sublease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
895
|
|
Asset impairment loss and (gain) loss on disposal of equipment
|
|
|
|
|
|
|
(10
|
)
|
|
|
|
|
|
|
2,056
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating costs and expenses
|
|
|
6,549
|
|
|
|
6,077
|
|
|
|
15,968
|
|
|
|
90,415
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(6,425
|
)
|
|
|
(5,997
|
)
|
|
|
(15,958
|
)
|
|
|
(87,686
|
)
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant valuation
|
|
|
|
|
|
|
7,127
|
|
|
|
|
|
|
|
6,759
|
|
Gain on sale of intellectual property to Medarex
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,656
|
|
Interest expense
|
|
|
(3,517
|
)
|
|
|
(2,564
|
)
|
|
|
(5,629
|
)
|
|
|
(21,330
|
)
|
Interest income
|
|
|
5
|
|
|
|
39
|
|
|
|
340
|
|
|
|
1,115
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(9,937
|
)
|
|
|
(1,395
|
)
|
|
|
(21,247
|
)
|
|
|
(97,486
|
)
|
Issuance of common stock in connection with elimination of Series A and
Series A-1 preferred stock preferences
|
|
|
|
|
|
|
|
|
|
|
(12,349
|
)
|
|
|
(12,349
|
)
|
Modification of Series A preferred stock warrants
|
|
|
|
|
|
|
|
|
|
|
(2,306
|
)
|
|
|
(2,306
|
)
|
Modification of Series A-1 preferred stock warrants
|
|
|
|
|
|
|
|
|
|
|
(16,393
|
)
|
|
|
(16,393
|
)
|
Series A preferred stock dividends
|
|
|
|
|
|
|
|
|
|
|
(334
|
)
|
|
|
(334
|
)
|
Series A-1 preferred stock dividends
|
|
|
|
|
|
|
|
|
|
|
(917
|
)
|
|
|
(917
|
)
|
Warrants issued on Series A and Series A-1 preferred stock dividends
|
|
|
|
|
|
|
|
|
|
|
(4,664
|
)
|
|
|
(4,664
|
)
|
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
|
|
$
|
(9,937
|
)
|
|
$
|
(1,395
|
)
|
|
$
|
(58,210
|
)
|
|
$
|
(142,295
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share applicable to common stockholders basic and diluted
|
|
$
|
(7.82
|
)
|
|
$
|
(0.39
|
)
|
|
$
|
(2.38
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares used in computing basic and diluted loss per
Share
|
|
|
1,271
|
|
|
|
3,562
|
|
|
|
24,420
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the consolidated financial statements.
F-4
NORTHWEST BIOTHERAPEUTICS, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY (DEFICIT) AND COMPREHENSIVE LOSS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred Stock
|
|
|
Preferred Stock
|
|
|
Additional
|
|
|
|
|
|
|
During the
|
|
|
Cumulative
|
|
|
Total
|
|
|
|
Common Stock
|
|
|
Series A
|
|
|
Series A-1
|
|
|
Paid-In
|
|
|
Deferred
|
|
|
Development
|
|
|
Translation
|
|
|
Stockholders
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Shares
|
|
|
Amount
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Compensation
|
|
|
Stage
|
|
|
Adjustment
|
|
|
Equity Deficit)
|
|
|
|
(In thousands)
|
|
Balances at March
18, 1996
|
|
|
|
|
|
$
|
|
|
|
|
|
|
|
$
|
|
|
|
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
Accretion of
membership units
mandatory
redemption
obligation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(106
|
)
|
|
|
|
|
|
|
(106
|
)
|
Comprehensive loss
net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,233
|
)
|
|
|
|
|
|
|
(1,233
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at
December 31, 1996
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,339
|
)
|
|
|
|
|
|
|
(1,339
|
)
|
Accretion of
membership units
mandatory
redemption
obligation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(275
|
)
|
|
|
|
|
|
|
(275
|
)
|
Comprehensive loss
net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,560
|
)
|
|
|
|
|
|
|
(2,560
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at
December 31, 1997
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,174
|
)
|
|
|
|
|
|
|
(4,174
|
)
|
Conversion of
membership units to
common stock
|
|
|
2,203
|
|
|
|
2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2
|
)
|
|
|
|
|
|
|
|
|
Accretion of Series
A preferred stock
mandatory
redemption
obligation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(329
|
)
|
|
|
|
|
|
|
(329
|
)
|
Comprehensive loss
net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,719
|
)
|
|
|
|
|
|
|
(4,719
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at
December 31, 1998
|
|
|
2,203
|
|
|
|
2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(9,224
|
)
|
|
|
|
|
|
|
(9,222
|
)
|
Issuance of Series
C preferred stock
warrants for
services related to
sale of Series C
preferred shares
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
394
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
394
|
|
Accretion of Series
A preferred stock
mandatory
redemption
obligation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(354
|
)
|
|
|
|
|
|
|
(354
|
)
|
Comprehensive loss
net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,609
|
)
|
|
|
|
|
|
|
(5,609
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at
December 31, 1999
|
|
|
2,203
|
|
|
|
2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
394
|
|
|
|
|
|
|
|
(15,187
|
)
|
|
|
|
|
|
|
(14,791
|
)
|
Issuance of Series
C preferred stock
warrants in
connection with
lease agreement
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
43
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
43
|
|
Exercise of stock
options for cash
|
|
|
2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1
|
|
Issuance of common
stock at $0.85 per
share for license
rights
|
|
|
5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4
|
|
Issuance of Series
D preferred stock
warrants in
convertible
promissory note
offering
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,039
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,039
|
|
Beneficial
conversion feature
of convertible
promissory notes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,026
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,026
|
|
Issuance of Series
D preferred stock
warrants for
services related to
sale of Series D
preferred shares
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
368
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
368
|
|
Issuance of common
stock warrants in
conjunction with
issuance of
promissory note
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3
|
|
Cancellation of
common stock
|
|
|
(275
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accretion of Series
A preferred stock
mandatory
redemption
obligation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(430
|
)
|
|
|
|
|
|
|
(430
|
)
|
Comprehensive loss
net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(12,779
|
)
|
|
|
|
|
|
|
(12,779
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at
December 31, 2000
|
|
|
1,935
|
|
|
|
2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,878
|
|
|
|
|
|
|
|
(28,396
|
)
|
|
|
|
|
|
|
(22,516
|
)
|
Issuance of Series
D preferred stock
warrants in
conjunction with
refinancing of note
payable to
stockholder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
225
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
225
|
|
Beneficial
conversion feature
of convertible
promissory note
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
456
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
456
|
|
Beneficial
conversion feature
of Series D
preferred stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,274
|
|
|
|
|
|
|
|
(4,274
|
)
|
|
|
|
|
|
|
|
|
Issuance of Series
D preferred stock
warrants for
services related to
the sale of Series
D preferred shares
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,287
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,287
|
|
Exercises of stock
options and
warrants for cash
|
|
|
1,158
|
|
|
|
1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
407
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
408
|
|
Issuance of common
stock in initial
public offering for
cash, net of
offering costs of
$2,845
|
|
|
4,000
|
|
|
|
4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17,151
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17,155
|
|
Conversion of
preferred stock
into common stock
|
|
|
9,776
|
|
|
|
10
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31,569
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31,579
|
|
Series A preferred
stock redemption
fee
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,700
|
)
|
|
|
|
|
|
|
(1,700
|
)
|
Issuance of stock
options to
nonemployees for
services
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
45
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
45
|
|
Deferred
compensation
related to employee
stock options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,330
|
|
|
|
(1,330
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of
deferred
compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
314
|
|
|
|
|
|
|
|
|
|
|
|
314
|
|
Accretion of Series
A preferred stock
mandatory
redemption
obligation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(379
|
)
|
|
|
|
|
|
|
(379
|
)
|
Comprehensive loss
net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(10,940
|
)
|
|
|
|
|
|
|
(10,940
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at
December 31, 2001
|
|
|
16,869
|
|
|
|
17
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
63,622
|
|
|
|
(1,016
|
)
|
|
|
(45,689
|
)
|
|
|
|
|
|
|
16,934
|
|
Issuance of
unregistered common
stock
|
|
|
1,000
|
|
|
|
1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
199
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
200
|
|
Issuance of common
stock, Employee
Stock Purchase Plan
|
|
|
9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6
|
|
Issuance of common
stock warrants to
Medarex
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
80
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
80
|
|
Issuance of
restricted stock to
nonemployees
|
|
|
8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
34
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
34
|
|
Issuance of stock
options to
nonemployees for
service
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
57
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
57
|
|
Issuance of stock
options to
employees
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
22
|
|
|
|
(22
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Cancellation of
employee stock
options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(301
|
)
|
|
|
301
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock
options and
warrants for cash
|
|
|
32
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18
|
|
Deferred
compensation
related to employee
restricted stock
option
|
|
|
99
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
449
|
|
|
|
(449
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Cancellation of
employee restricted
stock grants
|
|
|
(87
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(392
|
)
|
|
|
392
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of
deferred
compensation, net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
350
|
|
|
|
|
|
|
|
|
|
|
|
350
|
|
Comprehensive loss
net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(12,804
|
)
|
|
|
|
|
|
|
(12,804
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at
December 31, 2002
|
|
|
17,930
|
|
|
|
18
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
63,794
|
|
|
|
(444
|
)
|
|
|
(58,493
|
)
|
|
|
|
|
|
|
4,875
|
|
Issuance of
unregistered common
stock to Medarex
|
|
|
1,000
|
|
|
|
1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
199
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
200
|
|
Issuance of
unregistered common
stock to Nexus
|
|
|
90
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
35
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
35
|
|
Issuance of common
stock warrants to
Medarex
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
80
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
80
|
|
Issuance of
warrants with
convertible
promissory note
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
221
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
221
|
|
Beneficial
conversion feature
of convertible
promissory note
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
114
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
114
|
|
Issuance of common
stock, Employee
Stock Purchase Plan
|
|
|
4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock
options and
warrants for cash
|
|
|
8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cancellation of
employee restricted
stock grants
|
|
|
(4
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(20
|
)
|
|
|
20
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cancellation of
employee stock
options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(131
|
)
|
|
|
131
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of
deferred
compensation, net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
240
|
|
|
|
|
|
|
|
|
|
|
|
240
|
|
Non-employee stock
compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2
|
|
Comprehensive loss
net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,752
|
)
|
|
|
|
|
|
|
(5,752
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at
December 31, 2003
|
|
|
19,028
|
|
|
|
19
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
64,294
|
|
|
|
(53
|
)
|
|
|
(64,245
|
)
|
|
|
|
|
|
|
15
|
|
Issuance of
warrants with
convertible
promissory note
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,711
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,711
|
|
Beneficial
conversion feature
of convertible
promissory note
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,156
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,156
|
|
Issuance of common
stock, Employee
Stock Purchase Plan
|
|
|
1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cancellation of
employee stock
options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5
|
)
|
|
|
5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of
deferred
compensation, net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
41
|
|
|
|
|
|
|
|
|
|
|
|
41
|
|
Warrant valuation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
368
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
368
|
|
Comprehensive loss
net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(8,508
|
)
|
|
|
|
|
|
|
(8,508
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at
December 31, 2004
|
|
|
19,029
|
|
|
|
19
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
67,524
|
|
|
|
(7
|
)
|
|
|
(72,753
|
)
|
|
|
|
|
|
|
(5,217
|
)
|
Issuance of
unregistered common
stock and preferred
stock to Toucan
Capital
|
|
|
|
|
|
|
|
|
|
|
32,500
|
|
|
|
33
|
|
|
|
|
|
|
|
|
|
|
|
1,243
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,276
|
|
Issuance of stock
options to
non-employees for
services
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3
|
|
Issuance of
warrants with
convertible
promissory note
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,878
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,878
|
|
Exercise of stock
options and
warrants for cash
|
|
|
49
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4
|
|
Amortization of
deferred
compensation, net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7
|
|
|
|
|
|
|
|
|
|
|
|
7
|
|
Beneficial
conversion feature
of convertible
promissory note
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,172
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,172
|
|
Common Stock
warrant liability
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(604
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(604
|
)
|
Comprehensive loss
net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(9,937
|
)
|
|
|
|
|
|
|
(9,937
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at
December 31, 2005
|
|
|
19,078
|
|
|
|
19
|
|
|
|
32,500
|
|
|
|
33
|
|
|
|
|
|
|
|
|
|
|
|
71,220
|
|
|
|
|
|
|
|
(82,690
|
)
|
|
|
|
|
|
|
(11,418
|
)
|
Issuance of common
stock to PIPE
Investors for cash,
net of cash and
non-cash offering
costs of $837
|
|
|
39,468
|
|
|
|
39
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,649
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,688
|
|
Issuance of
warrants to PIPE
investment bankers
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
395
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
395
|
|
Conversion of notes
payable due to
Toucan Capital to
Series A-1
preferred stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,817
|
|
|
|
5
|
|
|
|
7,702
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,707
|
|
Conversion of notes
payable due to
management to
common stock
|
|
|
2,688
|
|
|
|
3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
266
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
269
|
|
Issuance of
warrants with
convertible
promissory notes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
236
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
236
|
|
Exercise of stock
options and
warrants for cash
|
|
|
66
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9
|
|
Exercise of stock
options and
warrants
cashless
|
|
|
3,942
|
|
|
|
4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock compensation
expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
19
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
19
|
|
Beneficial
conversion feature
of convertible
promissory note
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
64
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
64
|
|
Common Stock
warrant liability
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,523
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,523
|
)
|
Comprehensive loss
net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,395
|
)
|
|
|
|
|
|
|
(1,395
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at
December 31, 2006
|
|
|
65,241
|
|
|
$
|
65
|
|
|
|
32,500
|
|
|
$
|
33
|
|
|
|
4,817
|
|
|
$
|
5
|
|
|
$
|
78,033
|
|
|
$
|
|
|
|
$
|
(84,085
|
)
|
|
$
|
|
|
|
$
|
(5,949
|
)
|
Conversion of
common stock at par
related to the
reverse stock split
|
|
|
(60,892
|
)
|
|
|
(61
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
61
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of
Series A and A-1
preferred stock
into common stock
|
|
|
15,012
|
|
|
|
15
|
|
|
|
(32,500
|
)
|
|
|
(33
|
)
|
|
|
(4,817
|
)
|
|
|
(5
|
)
|
|
|
23
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common
stock in connection
with elimination of
Series A and Series
A-1 preferred stock
preferences
|
|
|
6,861
|
|
|
|
7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,342
|
|
|
|
|
|
|
|
(12,349
|
)
|
|
|
|
|
|
|
|
|
Modification of
preferred stock
Series A and Series
A-1 warrants
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,699
|
|
|
|
|
|
|
|
(18,699
|
)
|
|
|
|
|
|
|
|
|
Series A and Series
A-1 preferred stock
dividend payment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,251
|
)
|
|
|
|
|
|
|
(1,251
|
)
|
Warrants issued on
Series A and Series
A-1 preferred stock
dividends
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,664
|
|
|
|
|
|
|
|
(4,664
|
)
|
|
|
|
|
|
|
|
|
Issuance of common
stock in initial
public offering on
the AIM London
market for cash,
net of offering
costs of $3,965
|
|
|
15,789
|
|
|
|
16
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25,870
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25,886
|
|
Remeasurement of
warrants issued in
connection with
convertible
promissory notes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,495
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,495
|
|
Remeasurement of
beneficial
conversion feature
related to
convertible
promissory notes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,198
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,198
|
|
Exercise of
warrants
cashless
|
|
|
335
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock compensation
expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,679
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,679
|
|
Cumulative
translation
adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4
|
)
|
|
|
(4
|
)
|
Comprehensive loss
net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(21,247
|
)
|
|
|
|
|
|
|
(21,247
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other
comprehensive
loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(21,251
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at
December 31, 2007
|
|
|
42,346
|
|
|
$
|
42
|
|
|
|
|
|
|
$
|
|
|
|
|
|
|
|
$
|
|
|
|
$
|
148,064
|
|
|
$
|
|
|
|
$
|
(142,295
|
)
|
|
$
|
(4
|
)
|
|
$
|
(5,807
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the consolidated financial statements.
F-5
NORTHWEST BIOTHERAPEUTICS, INC.
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 18, 1996
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Inception) to
|
|
|
|
Year Ended December 31,
|
|
|
December 31,
|
|
|
|
2005
|
|
|
2006
|
|
|
2007
|
|
|
2007
|
|
|
|
(In thousands)
|
|
Cash Flows from Operating Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss
|
|
$
|
(9,937
|
)
|
|
$
|
(1,395
|
)
|
|
$
|
(21,247
|
)
|
|
$
|
(97,486
|
)
|
Reconciliation of net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
63
|
|
|
|
37
|
|
|
|
19
|
|
|
|
2,322
|
|
Amortization of deferred financing costs
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
320
|
|
Amortization of debt discount
|
|
|
2,908
|
|
|
|
1,988
|
|
|
|
5,750
|
|
|
|
17,996
|
|
Accrued interest converted to preferred stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
260
|
|
Accreted interest on convertible promissory note
|
|
|
603
|
|
|
|
324
|
|
|
|
363
|
|
|
|
1,484
|
|
Stock-based compensation costs
|
|
|
10
|
|
|
|
19
|
|
|
|
2,679
|
|
|
|
3,791
|
|
Loss (gain) on sale and disposal of property and equipment
|
|
|
(56
|
)
|
|
|
(10
|
)
|
|
|
|
|
|
|
273
|
|
Gain (loss) on sale of intellectual property and royalty rights
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,656
|
)
|
Warrant valuation
|
|
|
|
|
|
|
(7,127
|
)
|
|
|
|
|
|
|
(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
|
|
|
(64
|
)
|
|
|
72
|
|
|
|
3
|
|
|
|
|
|
Prepaid expenses and other current assets
|
|
|
34
|
|
|
|
(28
|
)
|
|
|
(646
|
)
|
|
|
(325
|
)
|
Accounts payable and accrued expenses
|
|
|
2,289
|
|
|
|
(810
|
)
|
|
|
582
|
|
|
|
1,774
|
|
Related party accounts payable and accrued expenses
|
|
|
|
|
|
|
|
|
|
|
(2,104
|
)
|
|
|
1,047
|
|
Accrued loss on sublease
|
|
|
1
|
|
|
|
|
|
|
|
|
|
|
|
(265
|
)
|
Deferred grant revenue
|
|
|
(35
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred rent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
410
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Cash used in Operating Activities
|
|
|
(4,184
|
)
|
|
|
(6,930
|
)
|
|
|
(14,601
|
)
|
|
|
(75,853
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows from Investing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property and equipment, net
|
|
|
(43
|
)
|
|
|
|
|
|
|
(24
|
)
|
|
|
(4,604
|
)
|
Proceeds from sale of property and equipment
|
|
|
97
|
|
|
|
17
|
|
|
|
|
|
|
|
250
|
|
Proceeds from sale of intellectual property
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,816
|
|
Proceeds from sale of marketable securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,000
|
|
Refund of security deposit
|
|
|
(3
|
)
|
|
|
|
|
|
|
|
|
|
|
(3
|
)
|
Transfer of restricted cash
|
|
|
(1
|
)
|
|
|
|
|
|
|
|
|
|
|
(1,035
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Cash (used in) provided by Investing Activities
|
|
|
50
|
|
|
|
17
|
|
|
|
(24
|
)
|
|
|
(1,576
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows from Financing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of note payable to stockholder
|
|
|
|
|
|
|
1,500
|
|
|
|
2,600
|
|
|
|
5,750
|
|
Repayment of note payable to stockholder
|
|
|
|
|
|
|
|
|
|
|
(5,050
|
)
|
|
|
(6,700
|
)
|
Proceeds from issuance of convertible promissory note and warrants,
net of issuance costs
|
|
|
3,050
|
|
|
|
300
|
|
|
|
|
|
|
|
13,099
|
|
Repayment of convertible promissory note
|
|
|
(54
|
)
|
|
|
(13
|
)
|
|
|
|
|
|
|
(119
|
)
|
Borrowing under line of credit, Northwest Hospital
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,834
|
|
Repayment of line of credit to Northwest Hospital
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,834
|
)
|
Payment on capital lease obligations
|
|
|
(38
|
)
|
|
|
(10
|
)
|
|
|
(2
|
)
|
|
|
(323
|
)
|
Payment on note payable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(420
|
)
|
Proceeds from issuance of preferred stock, net
|
|
|
1,276
|
|
|
|
|
|
|
|
|
|
|
|
28,708
|
|
Proceeds from exercise of stock options and warrants
|
|
|
4
|
|
|
|
8
|
|
|
|
|
|
|
|
227
|
|
Proceeds from issuance of common stock, net
|
|
|
|
|
|
|
5,083
|
|
|
|
25,886
|
|
|
|
48,343
|
|
Payment of preferred stock dividends
|
|
|
|
|
|
|
|
|
|
|
(1,251
|
)
|
|
|
(1,251
|
)
|
Series A preferred stock redemption fee
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,700
|
)
|
Deferred financing costs
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(320
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Cash provided by Financing Activities
|
|
|
4,238
|
|
|
|
6,868
|
|
|
|
22,183
|
|
|
|
85,294
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rates on cash
|
|
|
|
|
|
|
|
|
|
|
(4
|
)
|
|
|
(4
|
)
|
Net increase (decrease) in cash
|
|
|
104
|
|
|
|
(45
|
)
|
|
|
7,554
|
|
|
|
7,861
|
|
Cash at beginning of period
|
|
|
248
|
|
|
|
352
|
|
|
|
307
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash at end of period
|
|
$
|
352
|
|
|
$
|
307
|
|
|
$
|
7,861
|
|
|
$
|
7,861
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information
Cash paid during the period for interest
|
|
$
|
7
|
|
|
$
|
|
|
|
$
|
475
|
|
|
$
|
1,871
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental schedule of non-cash financing activities Equipment
acquired through capital leases
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
285
|
|
Issuance of common stock in connection with elimination of Series A
and Series A-1 preferred stock preferences
|
|
|
|
|
|
|
|
|
|
|
12,349
|
|
|
|
12,349
|
|
Modification of Series A preferred stock warrants
|
|
|
|
|
|
|
|
|
|
|
2,306
|
|
|
|
2,306
|
|
Modification of Series A-1 preferred stock warrants
|
|
|
|
|
|
|
|
|
|
|
16,393
|
|
|
|
16,393
|
|
Warrants issued on Series A and Series A-1 preferred stock dividends
|
|
|
|
|
|
|
|
|
|
|
4,664
|
|
|
|
4,664
|
|
Common stock warrant liability
|
|
|
604
|
|
|
|
6,523
|
|
|
|
|
|
|
|
11,841
|
|
Accretion of Series A preferred stock mandatory redemption obligation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,872
|
|
Beneficial conversion feature of convertible promissory notes
|
|
|
3,050
|
|
|
|
300
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
7,707
|
|
Conversion of convertible promissory notes and accrued interest to
common stock
|
|
|
|
|
|
|
269
|
|
|
|
|
|
|
|
269
|
|
Issuance of Series C preferred stock warrants in connection with
lease agreement
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
43
|
|
Issuance of common stock for license rights
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4
|
|
Liability for and 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
|
|
|
7
|
|
|
|
|
|
|
|
|
|
|
|
759
|
|
Cancellation of options and restricted stock grant
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
849
|
|
Financing of prepaid insurance through note payable
|
|
|
71
|
|
|
|
|
|
|
|
|
|
|
|
491
|
|
Stock subscription receivable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
480
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the consolidated financial statements.
F-6
NORTHWEST BIOTHERAPEUTICS, INC.
(A Development Stage Company)
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2005, 2006 and 2007
(1) Organization and Description of Business
Northwest Biotherapeutics, Inc. and its majority owned subsidiary (collectively, the
Company) was organized to discover and develop innovative diagnostics and immunotherapies for
prostate and brain cancer. During 1998, the Company incorporated as a Delaware corporation. Prior
to 1998, the Company was a limited liability company, which was formed on March 18, 1996. The
Company is a development stage company, has yet to generate significant revenues from its intended
business purpose and has no assurance of future revenues. While in the development stage, the
Companys principal activities have included defining and conducting research programs, conducting
clinical trials, raising capital and recruiting scientific and management personnel.
(2) Operations and Financing
Liquidity
The Company has experienced recurring losses from operations, has working capital of $5.8
million and has a deficit accumulated during the development stage of $142.3 million at December
31, 2007.
Since 2004, the Company has undergone a significant recapitalization pursuant to which Toucan
Capital Fund II, L.P. (Toucan Capital) loaned the Company an aggregate of $6.75 million and
Toucan Partners loaned the Company an aggregate of $4.825 million (excluding $225,000 in proceeds
from a demand note that was received on June 13, 2007 and repaid on June 27, 2007). The Companys
Chairperson is the managing director of Toucan Capital and the managing member of Toucan Partners.
During this period of time, the Company also borrowed funds from certain members of management. In
addition, the Company raised capital in March 2006 through a PIPE Financing and in June 2007 sold
shares of common stock to foreign institutional investors.
Management Loans
On November 13, 2003, the Company borrowed an aggregate of $335,000 from certain members of
its management and issued warrants to acquire an aggregate of approximately 247,000 shares of the
Companys common stock at an exercise price of $0.60 per share, which enabled the Company to
continue operating into the first quarter of 2004. As of December 31, 2005, $111,000 of outstanding
principal balance and the related accrued interest was repaid to certain prior members of
management. On April 17, 2006, the final $224,000 of outstanding principal balance on these notes,
and the related accrued interest, was converted into 146,385 and 32,796 shares, respectively, of
our common stock, and in conjunction with the PIPE Financing, members of management exercised their
warrants (200% warrant coverage) on a net exercise basis for 126,365 and 28,311 shares of our
common stock, respectively. Accordingly, as of December 31, 2006, all of these loans were either
repaid or converted into common stock.
During March and April 2006, warrants for the purchase of an aggregate of approximately
247,000 shares of common stock were exercised on a net exercise basis resulting in the issuance of
approximately 227,000 shares of common stock to current and prior members of management.
Two former members of the Companys management, who had participated as lenders in the
Companys management loans have claimed that they are entitled to receive, for no additional cash
consideration, an aggregate of up to approximately 630,000 additional shares of the Companys
common stock due to the alleged triggering of an anti-dilution provision in the warrant agreements.
The Company does not believe that these claims have merit, and intends to vigorously defend such
claims.
Toucan Capital and Toucan Partners
Toucan Capital loaned the Company an aggregate of $6.75 million during 2004 and 2005. 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 cumulative convertible
preferred stock (the Series A Preferred Stock) at a purchase price of $0.04 per share, for a net
purchase price of $1.276 million, net of offering related costs of approximately $24,000. In April
2006, the $6.75 million of notes payable plus all accrued interest due to Toucan Capital were converted into shares of the
Companys Series A-1 cumulative convertible Preferred Stock (the Series A-1 Preferred Stock).
F-7
Toucan Partners loaned the Company $4.825 million in a series of transactions. From November
14, 2005 through March 9, 2006, the Company issued three promissory notes to Toucan Partners,
pursuant to which Toucan Partners loaned the Company an aggregate of $950,000. In addition to the
$950,000 of promissory notes, Toucan Partners provided $3.15 million in cash advances from October
2006 through April 2007, which were converted into convertible notes (the 2007 Convertible Notes)
and related warrants (the 2007 Warrants) in April 2007. In April 2007, the three promissory notes
were amended and restated to conform to the 2007 Convertible Notes. Payment was due under the notes
upon written demand on or after June 30, 2007. Interest accrued at 10% per annum, compounded
annually, on a 365-day year basis. The principal amount of, and accrued interest on, these notes,
as amended, was convertible at Toucan Partners election into common stock on the same terms as the
2007 Convertible Notes.
The Company and Toucan Partners also entered into two promissory notes to fix the terms of two
additional cash advances provided by Toucan Partners to the Company on May 14, 2007 and May 25,
2007 in the aggregate amount of $725,000, and issued warrants to purchase shares of the Companys
capital stock to Toucan Partners in connection with each such note. These notes and warrants are on
the same terms as the 2007 Convertible Notes and 2007 Warrants and the proceeds of these notes
enabled the Company to continue to operate and advance programs while raising additional equity
financing.
During the fourth quarter of 2007, the Company repaid $5.3 million of principal and related
accrued interest due to Toucan Partners pursuant to the convertible notes.
Conversion of Preferred Stock and Related Matters
On June 1, 2007, the Company issued to Toucan Capital a new warrant to purchase the Companys
Series A-1 Preferred Stock (Toucan Capital Series A-1 Warrant) in exchange for the cancellation
of all previously issued warrants to purchase Series A-1 Preferred Stock (or, at the election of
Toucan Capital, any other equity or debt security of the Company) held by Toucan Capital. The new
Toucan Capital Series A-1 Warrant is exercisable for 6,471,333 shares of Series A-1 Preferred Stock
plus shares of Series A-1 Preferred Stock attributable to accrued dividends on the shares of Series
A-1 Preferred Stock held by Toucan Capital (with each such Series A-1 Preferred Share convertible
into 2.67 shares of common stock at $0.60 per share), compared to the 3,062,500 shares of Series
A-1 Preferred Stock (with each such Series A-1 Preferred Share convertible into 2.67 shares of
common stock at $0.60 per share) that were previously issuable to Toucan Capital upon exercise of
the warrants being cancelled.
Also on June 1, 2007, the Company and Toucan Capital amended Toucan Capitals warrant to
purchase Series A Preferred Stock (the Toucan Capital Series A Warrant) to increase the number of
shares of Series A Preferred Stock that are issuable upon exercise of the warrant to 32,500,000
shares of Series A Preferred Stock (plus shares of Series A Preferred Stock attributable to accrued
dividends on the shares of Series A Preferred Stock held by Toucan Capital) from 13,000,000 shares
of Series A Preferred Stock.
In connection with the modifications of the Series A and Series A-1 Preferred Stock warrants,
the Company recognized reductions in earnings applicable to common stockholders in June 2007 of
$2.3 million and $16.4 million, respectively. The fair value of the warrant modifications were
determined using the Black-Scholes option pricing model with the following assumptions: expected
dividend yield of 0%, risk-free interest rate of 5.0% volatility of 398%, and a contractual life of
seven years.
On June 15, 2007, the Company, Toucan Capital, and Toucan Partners entered into a conversion
agreement (Conversion Agreement) which became effective on June 22, 2007 upon the admission of
the Companys common stock to trade on Alternative Investment Market (AIM) of the London Stock
Exchange (Admission).
Pursuant to the terms of the Conversion Agreement (i) Toucan Capital agreed to convert and has
converted all of its shares of the Companys Series A Preferred Stock and Series A-1 Preferred
Stock (in each case, excluding any accrued and unpaid dividends) into common stock and agreed to
eliminate a number of rights, preferences and protections associated with the Series A Preferred
Stock and Series A-1 Preferred Stock, including the liquidation preference entitling Toucan Capital
to certain substantial cash payments and (ii) Toucan Partners agreed to eliminate all of its
existing rights to receive Series A-1 Preferred Stock under certain notes and warrants (and
thereafter to receive shares of common stock rather than shares of Series A-1 Preferred Stock), and
the rights, preferences and protections associated with the Series A-1 Preferred Stock, including
the liquidation preference that would entitle Toucan Partners to certain substantial cash payments. In return for these agreements, the Company issued to
Toucan Capital and Toucan Partners 4,287,851 and 2,572,710 shares of common stock, respectively. In
connection with the issuance of these shares, the Company recognized a further reduction of
earnings applicable to common stockholders of $12.3 million in June 2007.
F-8
Under the terms of the Conversion Agreement (i) the Toucan Capital Series A Warrant is
exercisable for 2,166,667 shares of common stock rather than shares of Series A Preferred Stock
(plus shares of common stock, rather than shares of Series A Preferred Stock, attributable to
accrued dividends on the shares of Series A Preferred Stock previously held by Toucan Capital that
were converted into common stock upon Admission, subject to the further provisions of the
Conversion Agreement as described below) and (ii) the Toucan Capital Series A-1 Warrant became
exercisable for an aggregate of 17,256,888 shares of common stock rather than shares of Series A-1
Preferred Stock (plus shares of common stock, rather than shares of Series A-1 Preferred Stock,
attributable to accrued dividends on the shares of Series A-1 Preferred Stock previously held by
Toucan Capital that were converted into common stock upon Admission), subject to further provisions
of the Conversion Agreement as described below.
As noted above, the 32,500,000 shares of Series A Preferred Stock held by Toucan Capital
converted, in accordance with their terms, into 2,166,667 shares of common stock and the 4,816,863
shares of Series A-1 Preferred Stock held by Toucan Capital converted, in accordance with their
terms, into 12,844,968 shares of common stock
Under the terms of the Conversion Agreement, Toucan Capital also agreed to temporarily defer
receipt of the accrued and unpaid dividends on its shares of Series A Preferred Stock and Series
A-1 Preferred Stock of an amount equal to $334,340 and $917,451, respectively, until not later than
September 30, 2007. In September 2007, we paid these dividends in full to Toucan Capital.
As a result of the financings described above, as of December 31, 2007, Toucan Capital held:
|
|
|
an aggregate of 19,299,486 shares of common stock;
|
|
|
|
|
warrants to purchase 14,150,732 shares of common stock at an exercise price of $0.60 per
share; and
|
|
|
|
|
warrants to purchase 7,884,357 shares of common stock at an exercise price of $0.15 per
share.
|
As a result of the financings described above, as of December 31, 2007, Toucan Partners held:
|
|
|
an aggregate of 2,572,710 shares of common stock; and
|
|
|
|
|
warrants to purchase 8,832,541 shares of common stock at an exercise price of $0.60 per
share.
|
The investments made by Toucan Capital and Toucan Partners were made pursuant to the terms and
conditions of a Recapitalization Agreement originally entered into on April 26, 2004 with Toucan
Capital. The Recapitalization Agreement, as amended, originally contemplated the investment of up
to $40 million through the issuance of new securities to Toucan Capital and a syndicate of other
investors to be determined.
We and Toucan Capital amended the Recapitalization Agreement in conjunction with each
successive loan agreement. The amendments generally (i) updated certain representations and
warranties of the parties made in the Recapitalization Agreement, and (ii) made certain technical
changes in the Recapitalization Agreement in order to facilitate the bridge loans described
therein.
Through June 22, 2007, the Company accrued and reimbursed certain legal and other
administrative costs on Toucan Capitals behalf pursuant to the Recapitalization Agreement.
Subsequent to June 22, 2007, Toucan Capital has incurred costs on behalf of the Company, primarily
related to travel expenses and fees incurred in connection with efforts to investigate and
establish DCVax® businesses in other locations overseas. In addition, effective July 1,
2007, the Company commenced accruing rent expense related to the sublease for its Bethesda,
Maryland office space from Toucan Capital. During the year ended December 31, 2007, the Company
recognized approximately $1.0 million of general and administrative costs related to this
Recapitalization Agreement, rent expense and other costs incurred by Toucan Capital on the
Companys behalf. Approximately $175,000 of these costs relate to activities which took place prior
to 2007. During the year ended December 31, 2006 the Company recognized $1.3 million of general and
administrative costs related to the Recapitalization Agreement. Pursuant to the terms of the
Conversion Agreement, the Recapitalization Agreement was terminated on June 22, 2007.
As of December 31, 2007, Toucan Capital, including the holdings of Toucan Partners,
beneficially owned of 21,872,196 shares of our capital stock, representing approximately 51.7% of
our outstanding common stock.
F-9
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 2.6 million shares of its common stock, at a price of $2.10 per share,
and to issue, for no additional consideration, warrants to purchase up to an aggregate of
approximately 1.3 million shares of the Companys common stock. The PIPE Financing closed and stock
was issued to the new investors in early April and the Company received gross proceeds of
approximately $5.5 million, before cash offering expenses of approximately $442,000. The total cost
of the offering recorded, including both cash and non-cash costs, was approximately $837,000. The
relative fair value of the common stock was estimated to be approximately $3.7 million and the
relative fair value of the warrants was estimated to be $1.8 million as determined based on the
relative fair value allocation of the proceeds received. The warrants were valued using the
Black-Scholes option pricing model.
In connection with the securities purchase agreement, the Company issued approximately 67,000
warrants to its investment banker valued at approximately $395,000. The fair value of the warrants
issued to the investment banker was determined using the Black-Scholes option pricing model based
on the following assumptions: risk free interest rate of 4.8%, contractual life of five years,
expected volatility of 382% and a dividend yield of 0%.
The warrants expire five years after issuance, and are initially exercisable at a price of
$2.10 per share, subject to adjustments under certain circumstances.
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 shares of
common stock underlying the warrants. Under the terms of the Purchase Agreement, the Company was
required to file a registration statement with the Securities and Exchange Commission (SEC)
within 45 days of the transaction closing date. 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
registration statement was filed on May 19, 2006 and amendments to the registration statement were
filed on July 17 and September 29, 2006. The registration statement was declared effective by the
SEC on October 11, 2006. Because the registration statement was not declared effective by the SEC
on or prior to September 1, 2006, the Company paid liquidated damages to the investors, in the
aggregate of one percent (1%) of the aggregate purchase price of the shares per month, or $74,000.
The registration statement became ineffective on April 30, 2007 and remained ineffective until
Post-Effective Amendment No. 2 became effective on February 8, 2008. As the Company is obligated to
keep the registration statement continually effective until March 30, 2012. Between April 30, 2007
and February 8, 2008, the Company accrued liquidated damages payable to the investors of $164,000.
Placement of Common Stock with Foreign Institutional Investors
On June 22, 2007, we placed 15,789,473 shares of our common stock with foreign institutional
investors at a price of £0.95 per share. The gross proceeds from the placement were approximately
£15.0 million, or $29.9 million, while net proceeds from the offering, after deducting commissions
and expenses, were approximately £13.0 million, or $25.9 million. The net proceeds from the
placement are being used to fund clinical trials, product and process development, working capital
needs and repayment of certain existing debt.
Liability For 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. Total potential outstanding common stock exceeded the Companys authorized shares as of
December 31, 2005 when the Company entered into another convertible promissory note and warrant
agreement with Toucan Partners on December 30, 2005. The fair value of the warrants in excess of
the authorized shares at December 31, 2005 totaling approximately $604,000 was recognized as a
liability on December 31, 2005. This liability was required to be remeasured at each reporting date
with any change in value included in other income/expense until such time as enough shares were
authorized to cover all potentially convertible instruments. Accordingly, during the first quarter
of 2006, the Company recognized a loss totaling $2.1 million with respect to the revaluation of
this warrant liability. Further, during March 2006, the Company issued an additional warrant to
Toucan Partners, along with a convertible promissory note. The fair value of the warrants in excess
of the authorized shares was approximately $6.7 million and was recognized as an additional
liability as of March 31, 2006. During April 2006, the Company sold common stock to outside
investors in the Pipe Financing. In addition, members of management and Toucan Capital elected to convert their promissory notes and related accrued interest into
common stock and Series A-1 Preferred Stock, respectively. As a result, the fair value of the
potential common stock in excess of the authorized shares was $24.4 million and was recognized as
an additional liability during April 2006.
F-10
Effective May 25, 2006, the number of authorized common shares was increased to 800 million.
The liability for potential shares in excess of total authorized shares was revalued at that date.
This valuation resulted in a gain of approximately $7.1 million during 2006, due to the net
decreases in the net fair value of the related warrants on the date the authorized shares were
increased. This gain is included in the 2006 consolidated statement of operations as a warrant
valuation.
Cost Recovery
We submitted an application to the FDA for cost recovery for our Phase II trial in brain
cancer. Approval of this application would permit us to charge patients or their insurers for the
direct costs of manufacturing DCVax®-Brain during this clinical trial. However because
we have changed the study design to include a placebo control arm we have no ability to charge
patients for DCVax®-Brain without unblinding the study and as a result, have ceased
pursuing this application.
Going Concern
We estimate that our available cash is sufficient to enable us to proceed with our continuing
activities under our pivotal DCVax®-Brain trial and begin treating patients with the
DCVax®-Brain vaccine pursuant to the BAG Authorisation. Although we believe that we have
funding available to pursue the activities described above, its adequacy will depend on many
factors, including the speed with which we are able to identify and hire people to fill key
positions, the speed of patient enrollment in our pivotal brain cancer trial, and the potential
adoption of DCVax®-Brain in the selected hospitals in Switzerland, and unanticipated
developments, including adverse developments in pending litigation matters. However, without
additional capital, we will not be able to complete our DCVax®-Brain clinical trial or
move forward with any of our other product candidates for which investigational new drug
applications have been cleared by the FDA. We will also be constrained in developing our second
generation manufacturing processes, which offer substantial product cost reductions.
We expect to require additional funding before we achieve profitability and there can be no
assurance that our efforts to seek such 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 registered public accounting firm has indicated in its report on our consolidated
financial statements included in the Annual Report on Form 10-K for the year ended December 31,
2007 that there is substantial doubt about our ability to continue as a going concern.
(3) Summary of Significant Accounting Policies
(a) Principles of Consolidation and Basis of Presentation
The accompanying consolidated financial statements of the Company were prepared in accordance
with accounting principles generally accepted in the United States of America (U.S. GAAP) and
include the assets, liabilities, revenues and expenses of the Companys majority-owned subsidiary
over which the Company exercises control. Intercompany transactions and balances are eliminated in
consolidation. The subsidiary was established in Switzerland during third quarter 2007. The Company
contributed 95% of the initial share capital in this new subsidiary and Cognate, a related party to
the Company, contributed the remaining 5%.
Certain reclassifications of prior years amounts have been made to conform to the
presentation adopted for 2007.
(b) Foreign Currency Translation
For operations outside the U.S. that prepare financial statements in currencies other than
U.S. dollars, we translate the financial statements into U.S. dollars. Results of operations and
cash flows are translated at average exchange rates during the period, and assets and liabilities
are translated at end of period exchange rates, except for equity transactions and advances not
expected to be repaid in the foreseeable future, which are translated at historical cost. The
effects of exchange rate fluctuations on translating foreign currency assets and liabilities into
U.S. dollars are accumulated as a separate component in other comprehensive income (loss).
F-11
(c) Use of Estimates in Preparation of Financial Statements
The preparation of financial statements in conformity with U.S. GAAP requires management to
make estimates and assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial statements and the
reported amounts of revenues and expenses during the reporting period. Actual results could differ
from those estimates.
(d) Cash
Cash consists of checking and money market accounts. While cash held by financial institutions
may at times exceed federally insured limits, management believes that no material credit or market
risk exposure exists due to the high quality of the institutions. The Company has not experienced
any losses on such accounts.
(e) Fair Value of Financial Instruments and Concentrations of Risk
Financial instruments, consisting of cash, accounts receivable, restricted cash, accounts
payable, accrued expenses, and capital lease obligations, are recorded at cost, which approximates
fair value based on the short term maturities of these instruments.
Credit is extended based on an evaluation of a customers financial condition and collateral
is generally not required. Accounts receivable are generally derived from revenue earned from
entities located in the United States. The Company records an allowance for potential credit losses
based upon the expected collectibility of the accounts receivable. To date, the Company has not
experienced any material credit losses.
In January 2003, research materials sales were made to multiple customers, primarily in the
United States of America, with whom there were no other contractual relationships. Effective
December 31, 2005, the Company no longer actively sells research materials.
(f) Property and Equipment
During 2003 and 2004, the Company determined that the carrying value of a significant part of
its fixed assets was not recoverable, and recorded an impairment charge to reduce the carrying
value of its long-lived assets to their estimated fair values. Property and equipment are stated at
cost, as adjusted for any prior impairments. Property and equipment are depreciated or amortized
over the following estimated useful lives using the straight-line method:
|
|
|
|
|
Laboratory equipment
|
|
5-7 years
|
Office furniture and other equipment
|
|
3-5 years
|
Expenditures for maintenance and repairs are expensed as incurred. Gains and losses from
disposal representing the difference between any proceeds received from the sale of property and
equipment and the recorded values of the asset disposed are recorded in total operating costs and
expenses.
(g) Impairment of long-lived assets
In accordance with the provisions of Statement of Financial Accounting Standards No. 144,
Accounting for the Impairment or Disposal of Long-Lived Assets
(SFAS No. 144), long-lived assets
including property and equipment are reviewed for possible impairment whenever significant events
or changes in circumstances, including changes in our business strategy and plans, indicate that an
impairment may have occurred. An impairment is indicated when the sum of the expected future
undiscounted net cash flows identifiable to that asset or asset group is less than its carrying
value. Long-lived assets to be held and used, including assets to be disposed of other than by
sale, for which the carrying amount is not recoverable are adjusted to their estimated fair value
at the date an impairment is indicated, which establishes a new basis for the assets for
depreciation purposes. Long-lived assets to be disposed of by sale are reported at the lower of
carrying amount or fair value less cost to sell. Impairment losses are determined from actual or
estimated fair values, which are based on market values, net realizable values or projections of
discounted net cash flows, as appropriate.
F-12
(h) Restricted Cash
Restricted cash of $31,000 as of December 31, 2006 represents a deposit to secure the
Companys credit limit on its corporate credit cards. No remaining restricted cash balance exists
at December 31, 2007.
(i) Operating Leases
The Company recognizes lease expense on a straight-line basis over the initial lease term. The
Company has an operating lease on real property expiring June 2008. For leases that contain rent
holidays or escalation clauses, the Company recognizes rent expense on a straight-line basis and
records the difference between the rent expense and rental amount payable as deferred rent. As of
December 31, 2007 and 2006, we did not have any deferred rent.
(j) Revenue Recognition
The Company has earned revenues through sale of research materials, providing research
services to third parties and through research grants in the past. Revenues from sale of research
materials are to multiple customers with whom there is no other contractual relationship and are
recognized when shipped to the customer and title has passed.
Research contracts and grants require the Company to perform research activities as specified
in each respective contract or grant on a best efforts basis, and the Company is paid based on the
fees stipulated in the respective contracts and grants which approximate the costs incurred by the
Company in performing such activities. The Company recognizes revenue under the research contracts
and grants based on completion of performance under the respective contracts and grants where no
ongoing obligation on the part of the Company exists. Direct costs related to these contracts and
grants are reported as research and development expenses.
(k) Research and Development Expenses
Research and development costs are expensed as incurred. These costs include, but are not
limited to, contract manufacturing costs, personnel costs, lab supplies, depreciation, amortization
and other indirect costs directly related to the Companys research and development activities.
(l) Income Taxes
Deferred income taxes are provided utilizing the liability method whereby the estimated future
tax effects of carry forwards and temporary differences between the financial statement carrying
amounts of existing assets and liabilities and their respective tax basis in accordance with
Statement of Financial Accounting Standards No. 109,
Accounting for Income Taxes
(SFAS No. 109).
Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to
taxable income in the years in which those carry forwards and temporary differences are expected to
be recovered or settled. The effect on the deferred tax assets and liabilities of a change in tax
rates is recognized in the period that includes the enactment date. A valuation allowance is
recorded on deferred tax assets if it is more likely than not that such deferred tax assets will
not be realized. Effective January 1, 2007, the Company adopted FASB Interpretation No. 48,
Accounting for Uncertainty in Income Taxes, an Interpretation of SFAS No. 109
,
Accounting for
Income Taxes
(FIN 48). The adoption of FIN 48 does not have a material effect on the Companys
results of operations. Prior to 1998, the Company was a limited liability company and the Companys
tax losses and credits generally flowed directly to the members.
(m) Stock-Based Compensation
On January 1, 2006, the Company adopted the provisions of Statement of Financial Accounting
Standards (SFAS) No. 123 (revised 2004),
Share-Based Payment
. SFAS No. 123(R) requires the
measurement and recognition of compensation for all stock-based awards including stock options and
employee stock purchases under a stock purchase plan, to be accounted for under the fair value
method and requires the use of an option pricing model for estimating fair value. Accordingly,
share-based compensation is measured at the grant date, based on the fair value of the award. In
prior years, we accounted for awards granted under our equity incentive plans under the intrinsic
value method prescribed by Accounting Principles Board (APB) Opinion No. 25,
Accounting for Stock
Issued to Employees
(APB No. 25), and related interpretations, and provided the required pro
forma disclosures prescribed by SFAS No. 123,
Accounting for Stock-Based Compensation
(SFAS No.
123)
,
as amended.
F-13
The Company adopted SFAS No. 123(R) using the modified prospective transition method, which
requires the application of the accounting standard as of January 1, 2006. The Companys
consolidated financial statements as of and for the years ended December 31, 2007 and 2006 reflect
the impact of SFAS No. 123(R). In accordance with the modified prospective transition method, the
Companys financial statements for periods prior to 2006 have not been restated to reflect this
change. Stock-based compensation recognized during the period is based on the value of the portion
of the stock-based award that will vest during the period, adjusted for expected forfeitures.
Stock-based compensation recognized in the Companys financial statements for 2006 includes
compensation cost for stock-based awards granted prior to, but not fully vested as of December 31,
2005 and stock-based awards granted subsequent to December 31, 2005. Stock-based compensation
expense related to employee stock options and employee stock purchase plans recognized under SFAS
No. 123(R) for the fiscal years ended December 31, 2007 and 2006 amounted to approximately $2.7
million and $19,000 on a pre-tax basis, respectively.
Stock compensation costs related to fixed employee awards with pro rata vesting are recognized
on a straight-line basis over the period of benefit, generally the vesting period of the options.
For options and warrants issued to non-employees, the Company recognizes stock compensation costs
utilizing the fair value methodology prescribed in SFAS No. 123 over the related period of benefit.
As stock-based compensation expense recognized in the Companys consolidated statements of
operations for the years ended December 31, 2007 and 2006 is based on awards ultimately expected to
vest, it has been reduced for estimated forfeitures. SFAS No. 123(R) requires forfeitures to be
estimated at the time of grant and revised, if necessary, in subsequent periods if actual
forfeitures differ from those estimates. The Company estimates forfeitures in the same manner under
SFAS No. 123(R) as it did prior to its adoption.
Stock-based compensation expense related to stock options recognized as a result of the
adoption of SFAS No. 123(R) was comprised as follows ($ in thousands, except for per share data):
|
|
|
|
|
|
|
|
|
Fiscal Years
|
|
2006
|
|
|
2007
|
|
Research and development
|
|
$
|
19
|
|
|
$
|
475
|
|
General and administrative expenses
|
|
|
|
|
|
|
2,204
|
|
|
|
|
|
|
|
|
Total stock-based compensation expense, before taxes
|
|
|
19
|
|
|
|
2,679
|
|
Related income tax benefits
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation expense, net of taxes
|
|
$
|
19
|
|
|
$
|
2,679
|
|
|
|
|
|
|
|
|
Earnings per share effect:
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
|
|
|
$
|
(0.11
|
)
|
Diluted
|
|
$
|
|
|
|
$
|
(0.11
|
)
|
|
|
|
|
|
Pro Forma Information Under SFAS No. 123 and APB Opinion No. 25
|
Prior to January 1, 2006, stock-based compensation plans were accounted for using the
intrinsic value method prescribed in APB No. 25 and related interpretations. Had compensation cost
for the plans been determined based on the fair value at the grant dates for awards under those
plans consistent with the method of SFAS No. 123, net loss and basic and diluted net loss per share
would have been changed to the pro forma amounts indicated below (in thousands, except for per
share data):
|
|
|
|
|
|
|
Year Ended
|
|
|
|
December 31,
|
|
|
|
2005
|
|
Net loss applicable to common stockholders:
|
|
|
|
|
As reported
|
|
$
|
(9,937
|
)
|
Add: Stock-based employee compensation expense included in reported net loss
|
|
|
7
|
|
Deduct: Stock-based employee compensation determined under fair value based method for all awards
|
|
|
(13
|
)
|
|
|
|
|
Pro forma
|
|
$
|
(9,943
|
)
|
|
|
|
|
Net loss per share-basic and diluted:
|
|
|
|
|
As reported
|
|
$
|
(7.82
|
)
|
Pro forma
|
|
$
|
(7.82
|
)
|
F-14
The fair value of stock options granted during 2005 was estimated using the Black-Scholes
option pricing model based on the following assumptions:
|
|
|
|
|
|
|
2005
|
|
Risk-free interest rate
|
|
|
3.53
|
%
|
Expected life
|
|
5 years
|
Expected volatility
|
|
|
403
|
%
|
Dividend yield
|
|
|
0
|
%
|
See Note 4, Stock-Based Compensation, for additional information concerning the Companys
stock-based compensation plans.
(n) Loss Per Share
Basic loss per share is computed on the basis of the weighted average number of shares
outstanding for the reporting period. Diluted loss per share is computed on the basis of the
weighted average number of common shares plus dilutive potential common shares outstanding using
the treasury stock method. Any potentially dilutive securities are antidilutive due to the
Companys net losses. For the periods presented, there is no difference between the basic and
diluted net loss per share.
Effective June 19, 2007, all shares of the Companys common stock issued and outstanding were
combined and reclassified on a one-for-fifteen basis. The effect of this reverse stock split has
been retroactively applied to all periods presented.
(o) Operating Segments
The Company is principally engaged in the discovery and development of innovative
immunotherapies for cancer and has a single operating segment as management reviews all financial
information together for the purposes of making decisions and assessing the financial performance
of the Company.
Operating costs:
Operating costs and expenses consist primarily of research and development expenses, including
clinical trial expenses which arise when we are actively participating in clinical trials, and
general and administrative expenses.
Research and development:
Discovery and preclinical research and development expenses include scientific personnel
related salary and benefit expenses, costs of laboratory supplies used in our internal research and
development projects, travel, regulatory compliance, and expenditures for preclinical and clinical
trial operation and management when we are actively engaged in clinical trials.
Because the Company is a development stage company, it does not allocate research and
development costs on a project basis. The Company adopted this policy, in part, due to the
unreasonable cost burden associated with accounting at such a level of detail and its limited
number of financial and personnel resources. The Companys business judgment continues to be that
there is little value associated with evaluating expenditures at the project level since the
Company is focusing primarily on its lead clinical trial programs as most of the Companys
expenditures relate to those programs.
For the year ended December 31, 2007, of the Companys operating expenses of approximately
$16.0 million, approximately 54% of its expended resources were apportioned to the re-activation of
its two DCVax® clinical trial programs. From its inception through December 31, 2007,
the Company incurred costs of approximately $44.6 million associated with its research and
development activities. Because its technologies are novel and unproven, the Company is unable to
estimate with any certainty the costs it will incur in the continued development of its product
candidates for commercialization.
F-15
General and administrative:
General and administrative expenses include administrative personnel related salary and
benefit expenses, cost of facilities, insurance, travel, legal support, property and equipment
depreciation, amortization of stock options and warrants, and amortization of debt discounts and
beneficial conversion costs associated with the Companys debt financing.
(p) Recent Accounting Pronouncements
In September 2006, the Financial Accounting Standards Board, or FASB, issued SFAS No. 157,
Fair Value Measurements
(SFAS No. 157). SFAS No. 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 No. 157 is effective for financial statements issued for
fiscal years beginning after November 15, 2007, and interim periods within those fiscal years. The
adoption of this standard is not expected to have a significant impact on the Companys
consolidated financial position or results of operations.
In February 2007, the FASB issued SFAS No. 159,
The Fair Value Option for Financial Assets and
Financial Liabilities
(SFAS No. 159). SFAS No. 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 No. 159 is effective for financial statements issued for fiscal
years beginning after November 15, 2007. The Company is currently evaluating the impact of adopting
SFAS No. 159 on the Companys financial position.
In December 2007, the FASB issued SFAS No. 141(R),
Business Combinations a Replacement of
FASB Statement No. 141
(SFAS No. 141(R)). The statement is to be applied prospectively for fiscal
years beginning on or after December 15, 2008; therefore, it applies to future business
combinations. The statement requires more assets acquired and liabilities assumed in future
business combinations to be measured at fair value as of the acquisition date. In addition,
expenses incurred for all acquisition-related costs are to be expensed and liabilities related to
contingent consideration are to be remeasured to fair value each subsequent reporting period. We
will adopt SFAS No. 141(R) effective January 1, 2009. We are currently evaluating the impact this
statement may have on our consolidated financial position or results of operations.
In December 2007, the FASB issued SFAS No. 160,
Noncontrolling Interests in Consolidated
Financial Statements an amendment of ARB No. 51
(SFAS No. 160) . The statement changes how
noncontrolling interests in subsidiaries are measured to initially be measured at fair value and
classified as a separate component of equity. SFAS No. 160 establishes a single method of
accounting for changes in a parents ownership interest in a subsidiary that do not result in
deconsolidation. No gains or losses will be recognized on partial disposals of a subsidiary where
control is retained. In addition, in partial acquisitions, where control is obtained, the acquiring
company will recognize and measure at fair value all of the assets and liabilities, including
goodwill, as if the entire target company had been acquired. The statement is to be applied
prospectively for fiscal years beginning on or after December 15, 2008. We will adopt the statement
on January 1, 2009. We are currently evaluating the impact this statement will have, if any, on our
consolidated financial position or results of operations.
In June 2007, the EITF issued EITF Issue No. 07-3,
Accounting for Nonrefundable Advance
Payments for Goods or Services to be Used in Future Research and Development Activities
(EITF
07-3), which is effective for fiscal years beginning after December 15, 2007. EITF 07-3 requires
that nonrefundable advance payments for future research and development activities be deferred and
capitalized. Such amounts will be recognized as an expense as the goods are delivered or the
related services are performed. The Company does not expect the adoption of EITF 07-3 to have a
material impact on the financial results of the Company.
4. Share-Based Compensation Plans
Effective January 1, 2006, the Company adopted SFAS No. 123(R), which establishes accounting
for stock-based awards exchanged for goods or services, using the modified prospective transition
method. Accordingly, stock-based compensation cost is measured at grant date, based on the fair
value of the award, recognized over the requisite service period. Previously, the Company applied
APB No. 25 and related interpretations, as permitted by SFAS No. 123.
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.
F-16
Determining Fair Value Under SFAS No. 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 its common stock at the date of
grant based on the historical volatility of its 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 Companys employee stock purchase
plan during 2007 and 2006.
The stock-based compensation expense recognized in the financial statements relate to
stock-based awards under SFAS No. 123(R) totaled approximately $19,000 for 2006 which increased the
loss from operations and net loss by the same amount. This expense had no effect on the Companys
net loss per share for the year ended December 31, 2006. As of December 31, 2007, the Company had
approximately $9.0 million of total unrecognized compensation cost related to non-vested
stock-based awards granted under all equity compensation plans. Total unrecognized compensation
cost will be adjusted for any future changes in estimated forfeitures. The Company expects to
recognize this cost from 2008 through 2011. Total intrinsic value of options exercised was $18,000
for 2006. There were no options exercised in 2007. Weighted average fair value of options granted
during 2007 and 2006 was $2.48 and $1.65 per share, respectively.
Stock Option Activity
A summary of activity relating to our stock options is as follows (options in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
Average
|
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
Remaining
|
|
|
Aggregate
|
|
|
|
|
|
|
|
Exercise
|
|
|
Contractual
|
|
|
Intrinsic
|
|
|
|
Options
|
|
|
Price
|
|
|
Term (Years)
|
|
|
Value
|
|
Outstanding as of December 31, 2006
|
|
|
51
|
|
|
$
|
7.95
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
4,724
|
|
|
$
|
0.89
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expired
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding as of December 31, 2007
|
|
|
4,775
|
|
|
$
|
0.97
|
|
|
|
4.9
|
|
|
$
|
7,804,432
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested at December 31, 2007
|
|
|
1,078
|
|
|
$
|
0.95
|
|
|
|
4.0
|
|
|
$
|
2,015,519
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable as of December 31, 2007
|
|
|
1,078
|
|
|
$
|
0.95
|
|
|
|
4.0
|
|
|
$
|
2,015,519
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-17
Additional information regarding stock options outstanding and exercisable at December 31,
2007 is as follows, in thousands, except option price and weighted average exercise price.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding
|
|
|
Options Exercisable
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
Weighted
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
Remaining
|
|
|
Average
|
|
|
|
|
|
|
Average
|
|
|
|
Number
|
|
|
Contractual
|
|
|
Exercise
|
|
|
Number
|
|
|
Exercise
|
|
Range of Exercise Prices
|
|
Outstanding
|
|
|
Life (Years)
|
|
|
Price
|
|
|
Exercisable
|
|
|
Price
|
|
|
|
(In thousands except weighted average)
|
|
$0.00 - 0.60
|
|
|
3,955
|
|
|
|
4.0
|
|
|
$
|
0.60
|
|
|
|
1,027
|
|
|
$
|
0.60
|
|
$0.61 - 2.40
|
|
|
799
|
|
|
|
9.6
|
|
|
|
2.38
|
|
|
|
30
|
|
|
|
1.76
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$2.41 - 75.00
|
|
|
21
|
|
|
|
2.9
|
|
|
$
|
17.01
|
|
|
|
21
|
|
|
$
|
17.01
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$0.00 - 75.00
|
|
|
4,775
|
|
|
|
4.9
|
|
|
$
|
0.97
|
|
|
|
1,078
|
|
|
$
|
0.95
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable as of December 31, 2005, 2006 and 2007 totaled 40,000, 42,000 and
1,078,000, respectively.
F-18
Stock Option Plans
The Companys stock option plans are administered by the Board of Directors, which determines
the terms and conditions of the options granted, including exercise price, number of options
granted and vesting period of such options. A brief description of these plans follows. The Company
amended its then existing equity plans effective June 22, 2007 such that no further option grants
may be made under those plans.
Options granted under the plans are generally priced at or above the estimated fair market
value of the Companys common stock on the date of grant and generally vest over four years.
Compensation expense, if any, is charged over the period of vesting. All options, if not previously
exercised or canceled, expire ten years from the date of grant, or the expiration date specified in
the individual option agreement, if earlier.
During the year ended December 31, 2005, the Company granted non-qualified options to purchase
an aggregate of 1,667 shares of common stock to a non-employee consultant with a weighted average
exercise price of $3.15. The fair value of the underlying common stock is evaluated monthly for
specific performance compliance with $510 of compensation expense recognized for the year ended
December 31, 2005.
During the year ended December 31, 2006, the Company granted options to purchase an aggregate
of 11,667 shares of common stock to employees with a weighted average exercise price of $2.10.
Stock compensation expense totaling $19,000 was recorded as of December 31, 2006.
During the year ended December 31, 2007, the Company granted options to purchase an aggregate
of 4,724,000 shares of common stock to employees with a weighted average exercise price of $0.89.
Stock compensation expense totaling $2.7 million was recorded as of December 31, 2007.
(a) 1998 Stock Option Plan
The Companys 1998 Stock Option Plan (the 1998 Plan) has reserved 27,535 shares of common
stock for stock option grants to employees, directors and consultants of the Company. As of
December 31, 2007, net of forfeitures, a total of 23,783 shares remain available for granting under
this plan; however, no further grants may be made under this plan. Our Board of Directors has the
authority to amend or terminate this plan, but such action will not adversely affect any
outstanding option without the optionees consent. If not terminated earlier, this plan will
terminate in July 2008.
(b) 1999 Executive Stock Option Plan
The Companys 1999 Executive Stock Option Plan (the 1999 Plan) has reserved 39,078 shares of
common stock for issuance. As of December 31, 2006, net of forfeiture, a total of 28,064 shares
remain available for granting under this plan; however, no further grants may be made under this
plan. Our Board of Directors has the authority to amend or terminate this plan, but such action
will not adversely affect any outstanding option without the optionees consent. If not terminated
earlier, this plan will terminate in November 2009.
(c) 2001 Stock Option Plan
Under the 2001 Stock Option Plan (the 2001 Plan), 120,000 shares of the Companys common
stock have been reserved for grant of stock options to employees and consultants. Additionally, on
January 1 of each year, commencing January 1, 2002, the number of shares reserved for grant under
the 2001 Plan will increase by the lesser of (i) 15% of the aggregate number of shares available
for grant under the 2001 Plan or (ii) 20,000 shares. As of December 31, 2007, net of forfeitures, a
total of 162,603 shares remain available under this plan; however, no further grants may be made
under this plan. Our Board of Directors has the authority to amend or terminate this plan, but such
action may not adversely affect any outstanding option previously granted under the plan. If this
plan is not terminated earlier, no incentive stock options can be granted under the plan on or
after the later of June 2011 or the 10th anniversary of the date when our Board of Directors
adopted, subject to approval by our stockholders, the most recent increase in the number of shares
available for grant under the plan.
F-19
(d) 2001 Non-employee Director Stock Incentive Plan
Under the 2001 Non-employee Director Stock Incentive Plan (the 2001 Director Plan), 13,333
shares of the Companys common stock have been reserved for grant of stock options to non-employee
directors of the Company. As of December 31, 2007, net of forfeitures, a total of 10,500 shares
remain available under this plan; however, no further grants may be made under this plan.
(e) 2007 Stock Option Plan
The Company established a stock option plan, which became effective on June 15, 2007 (the
2007 Stock Option Plan). The Company has reserved a total of 5,480,868 shares of common stock for
issuance in respect of options granted under the plan. The plan provides for the grant to employees
of the Company, its parents and subsidiaries, including officers and employee directors, of
incentive stock options within the meaning of Section 422 of the Code and for the grant of
non-statutory stock options to the employees, officers, directors, including non-employee
directors, and consultants of the Company, its parents and subsidiaries. To the extent an optionee
would have the right in any calendar year to exercise for the first time one or more incentive
stock options for shares having an aggregate fair market value, under all of the Companys plans
and determined as of the grant date, in excess of $100,000, any such excess options will be treated
as non-statutory options. As of December 31, 2007, net of forfeitures, a total of 756,406 shares
remain available for issuance under this plan.
(f) Employee Stock Purchase Plan
Our Employee Stock Purchase Plan (the Employees Plan) was adopted by our Board of Directors
and approved by our stockholders in June 2001. A total of 33,333 shares of common stock have been
reserved for issuance under this plan and, as of December 31, 2007, 958 shares have been issued
under this plan.
This plan is administered by the Compensation Committee of our Board of Directors and provides
a mechanism for eligible employees to purchase shares of our common stock. To facilitate these
purchases, eligible participants are assigned plan accounts, to which they may contribute funds via
payroll deduction. The purchases are accomplished through the use of six-month offering periods.
Purchases pursuant to this plan are made at a price equal to the lower of (i) 85% of the fair
market value of our common stock on the last trading day in the offering period; or (ii) 85% of the
fair market value of our common stock on the last trading day before the commencement of such
offering period. No participant may purchase more than 67 shares of our common stock during any
offering period. Additionally, purchases under the plan are limited such that no participant may
purchase under the plan, in any offering period that commenced in that calendar year, shares with a
fair market value in excess of $25,000 minus the fair market value of any shares that the
participant previously purchased in that calendar year. In the case of shares purchased during an
offering period that commenced in the preceding calendar year, the limitation is $50,000 minus the
fair market value of any shares that the participant purchased during the calendar year of the
purchase and the calendar year immediately preceding such purchase.
Our Board of Directors has the authority to amend or terminate this plan at any time.
Amendments to the plan are subject to approval by our stockholders to the extent required by
applicable law.
5) Stockholders Equity (Deficit)
(a) Issuance of Common Stock and Warrants
In April 2006, the Company received gross proceeds of $5.5 million and issued approximately
2.6 million shares of its common stock, at a price of $2.10 per share, and, for no additional
consideration, warrants to purchase up to an aggregate of approximately 1.3 million shares of the
Companys common stock pursuant to a securities purchase agreement entered into with a group of
accredited investors. The Company initially registered both the shares of common stock and the
shares of common stock underlying the warrants for resale under the Securities Act of 1933, as
amended, effective October 2006.
In connection with the securities purchase agreement, the Company issued approximately 67,000
warrants to its investment banker, valued at approximately $395,000.
This transaction is more fully described in note (2) Operations and Financing.
F-20
(b) Stock Purchase Warrants
Medarex
On December 9, 2002, the Company entered into an assignment and license agreement with Medarex
wherein the Company sold certain intellectual property to Medarex in exchange for certain of its
intellectual property and received $3.0 million, consisting of $1.0 million in cash and two
payments of $1.0 million each payable in common stock. The Company realized a total of $3.0 million
in cash as all of the foregoing shares were sold within 30 days of their issuance in 2003.
Additionally, a $400,000 payable of ours to Medarex was forgiven by Medarex. Pursuant to this
agreement, the Company issued to Medarex approximately 133,000 unregistered shares of its common
stock. The 133,000 shares of unregistered common stock were issued in 2002 and 2003. Also in
conjunction with the December 9, 2002 agreement with Medarex, the Company issued warrants to
purchase 53,333 shares of unregistered common stock in 2002 and 2003 at exercise prices ranging
from $1.53 to $3.24 per share. The warrants may be exercised at any time after six-months following
their issue date and prior to the tenth anniversary of the issue date, or by various dates between
December 25, 2012 through February 9, 2013.
The fair value of the 53,333 warrant shares was $159,678 on the date of grant, which was
determined using the Black-Scholes option pricing model with the following assumptions: expected
dividend yield 0%, risk-free interest rate of 4.17%, volatility of 191%, and an expected life of
10-years. As of December 31, 2002, one-half of the warrant value, $79,839, was recognized as an
increase to additional paid in capital and $79,839 was recognized as a long-term liability, for the
400,000 warrant shares to be issued in 2003.
The net gain recognized on this sale of intellectual property was $2.8 million, made up of the
receipt of $3.0 million of cash and stock from Medarex and forgiveness of the $400,000 payable to
Medarex, offset by the issuance of 133,000 shares of unregistered common stock and warrants to
purchase 53,333 shares of common stock valued at approximately $560,000.
Management Loan Warrants
On November 13, 2003, the Company borrowed an aggregate of $335,000 from certain members of
its current and former management. As part of the November 13, 2003 loans from management, the
lenders received warrants initially exercisable to acquire an aggregate of approximately 247,000
shares of the Companys common stock.
During March and April 2006, warrants for the purchase an aggregate of 247,000 million shares
of common stock were exercised on a net exercise basis resulting in the issuance of approximately
227,000 shares of common stock to current and prior members of management.
Toucan Capital and Toucan Partners Warrants
From February 1, 2004 through December 31, 2006, the Company issued warrants for 8.2 million
shares of Company capital stock to Toucan Capital pursuant to which Toucan Capital had loaned the
Company an aggregate of $6.75 million in loan financing, as more fully described in note (2)
Operations and Financing.
On January 26, 2005, we issued Toucan Capital a warrant, with a contractual life of 7 years,
to purchase 13.0 million shares of Series A Preferred Stock in connection with a securities
purchase agreement pursuant to which Toucan Capital purchased 32.5 million shares of our newly
designated Series A Preferred Stock at a purchase price of $0.04 per share, for an aggregate
purchase price of $1.3 million. The number of shares issuable pursuant to the exercise of the
warrant and the exercise price thereof is subject to adjustment in the event of stock splits,
reverse stock splits, stock dividends and the like, as more fully described in note (2) Operations
and Financing.
From November 14, 2006 through June 1, 2007, the Company issued warrants for 8.8 million
shares of Company capital stock to Toucan Partners pursuant to which Toucan Partners loaned the
Company $4.825 million in loan financing. These loans and related warrants were amended and
restated in April 2007 and in June 2007 as more fully described in note (2) Operations and
Financing. During the fourth quarter of 2007, the Company repaid the entire $5.3 million in
principal and related accrued interest due to Toucan Partners pursuant to the convertible notes.
F-21
Private Placement Warrants
On April 4, 2006, the Company closed an offering with a group of accredited investors pursuant
to which the Company sold an aggregate of approximately 2.6 million shares of its common stock, at
a price of $2.10 per share, and issued, for no additional consideration, warrants to purchase up to
an aggregate of approximately 1.3 million shares of the Companys common stock at an exercise price
of $2.10 per share. As of December 31, 2007, approximately 677,000 of these warrants remained
outstanding.
A summary of the warrants outstanding at December 31, 2007 is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-
|
|
|
Number
|
|
Average
|
Type of Warrant
|
|
Outstanding
|
|
Exercise Price
|
|
|
(In thousands)
|
|
|
|
|
Common stock warrant
|
|
|
797
|
|
|
$
|
2.15
|
|
Common stock warrants issued in connection with Series A preferred stock
|
|
|
4,778
|
|
|
$
|
0.48
|
|
Series C Preferred Stock warrants(1)
|
|
|
16
|
|
|
$
|
37.50
|
|
Series D Preferred Stock warrants(1)
|
|
|
22
|
|
|
$
|
75.00
|
|
Warrants issued in connection with convertible promissory notes
|
|
|
26,089
|
|
|
$
|
0.49
|
|
|
|
|
(1)
|
|
The exercise of Series C and Series D Preferred Stock warrants will
result in the issuance of an equal number of shares of the Companys
common stock with no issuance of preferred stock.
|
The exercise of Series A Preferred Stock warrants will result in the issuance of an equal
number of shares of the Companys Series A Preferred Stock.
(d) Common Stock Equivalents
The following common stock equivalents on an as-converted basis were excluded from the
calculation of diluted net loss per share, as the effect would be antidilutive.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31
|
|
|
2005
|
|
2006
|
|
2007
|
|
|
(In thousands)
|
Preferred stock
|
|
|
2,167
|
|
|
|
2,167
|
|
|
|
|
|
Common stock options
|
|
|
50
|
|
|
|
51
|
|
|
|
51
|
|
Common stock warrants
|
|
|
54
|
|
|
|
1,388
|
|
|
|
797
|
|
Convertible preferred stock warrants
|
|
|
906
|
|
|
|
906
|
|
|
|
4,778
|
|
Convertible promissory note
|
|
|
12,420
|
|
|
|
1,743
|
|
|
|
|
|
Convertible promissory note stock warrants
|
|
|
8,848
|
|
|
|
8,800
|
|
|
|
26,089
|
|
(e) Employee Stock Purchase Plan
In June 2001, the Company adopted an employee stock purchase plan which became effective upon
consummation of the Companys initial public offering and reserved 500,000 shares of common stock
for issuance under this plan. Under this plan, employees may purchase up to 1,000 shares of the
Companys common stock during each six-month offering period commencing on April 1 and October 1 of
each year. The purchase price of the common stock is equal to the lower of 85% of the market price
on the first and last day of each offering period. As of December 31, 2007, a total of 14,374
shares have been issued under the plan.
(f) Employee 401(k) Plan
On August 19, 1999, the Company adopted a 401(k) Plan for certain eligible employees. Under
the plan, an eligible employee may elect to contribute up to 60% of his or her pre-tax total
compensation, not to exceed the annual limits established by the Internal Revenue Service. The
Company matched an employees contribution at the rate of $0.50 for every employee contributed
dollar with a maximum Company match of $3,000 annually. Effective March 1, 2006, the Company no longer
matches employee contributions. For the years ended December 31, 2005 and 2006, the Company made
matching contributions of approximately $15,000 and $6,000, respectively.
F-22
(g) Stockholder Rights Agreement
On March 6, 2002, the Company adopted a Stockholder Rights Agreement, under which each common
stockholder of record at the close of business on March 4, 2002 received a dividend of one right
per share of common stock held. Each right entitles the holder to purchase one share of common
stock from the Company at a price equal to $19.25 per share, subject to certain anti-dilution
provisions. The rights become exercisable only in the event that a third party acquires beneficial
ownership of, or announces a tender or exchange offer for, at least 15% of the then outstanding
shares of the Companys common stock and such acquisition or offer is determined by the Board of
Directors to not be in the best interests of the stockholders. If the acquisition or offer were
determined by the Board of Directors to be in the best interests of the stockholders, the rights
may be redeemed by the Company for $0.0001 per right. The rights will expire on February 25, 2012,
unless earlier redeemed, exchanged or terminated in accordance with the rights agreement.
In connection with the Recapitalization Agreement, the Board of Directors and Mellon Investor
Services LLC, its Rights Agent, on April 26, 2004, amended the Stockholder Rights Agreement. The
definition of an Acquiring Person was amended to exclude Toucan Capital Fund II, L.P. and other
investors selected by Toucan from the definition of Acquiring Person for those shares of the
Companys capital stock they acquire, or are deemed to beneficially own, in connection with the
Recapitalization Agreement.
(6) Related Party Transactions
(a) Notes Payable to Related Parties
Convertible promissory notes have been issued to Toucan Capital and Toucan Partners, an
affiliate of Toucan Capital, the Companys controlling shareholder. As of December 31, 2007, all of
the issued notes have either been converted or repaid.
Notes payable to related parties are more fully described in note (2) Operations and Financing
and note (10) Notes Payable.
(b) Cognate Agreement
On July 30, 2004, the Company entered into a service agreement with Cognate Therapeutics, Inc.
(now known as Cognate BioServices, Inc., or Cognate), a contract manufacturing and services
organization in which Toucan Capital has a majority interest. In addition, two of the principals of
Toucan Capital are members of Cognates board of directors and, on May 17, 2007, the managing
director of Toucan Capital was appointed to serve as a director of the Company and to serve as the
non-executive Chairperson of the Companys Board of Directors. Under the service agreement, the
Company agreed to utilize Cognates services for an initial two-year period, related primarily to
manufacturing DCVax® product candidates, regulatory advice, research and development
preclinical activities and managing clinical trials. The agreement expired on July 30, 2006;
however, the Company continued to utilize Cognates services under the same terms as set forth in
the expired agreement. On May 17, 2007, the Company entered into a new service agreement with
Cognate pursuant to which Cognate will provide certain consulting and, when needed, manufacturing
services to the Company for its DCVax®-Brain Phase II clinical trial. Under the terms of
the new contract, the Company paid a non-refundable contract initiation fee of $250,000 and
committed to pay budgeted monthly service fees of $400,000, subject to quarterly true-ups, and
monthly facility fees of $150,000. The Company may terminate this agreement with 180 days notice
and payment of all reasonable wind-up costs and Cognate may terminate the contract in the event
that the brain cancer clinical trial fails to complete enrollment by July 1, 2009. However, if such
termination by the Company occurs at any time prior to the earlier of the submission of an FDA
biological license application/new drug application on the Companys brain cancer clinical trial or
July 1, 2010 or, such termination by Cognate results from failure of the brain cancer clinical
trial to complete patient enrollment by July 1, 2009, the Company is obligated to make an
additional termination fee payment to Cognate equal to $2 million.
During the years ending December 31, 2005, 2006 and 2007, respectively, the Company recognized
approximately $3.5 million, $2.4 million and $5.8 million of research and development costs related
to these service agreements. As of December 31, 2007 and 2006, the Company owed Cognate
approximately $0 and $2.2 million, respectively.
F-23
(c) Toucan Capital Management
In accordance with a recapitalization agreement dated April 26, 2004 between the Company and
Toucan Capital, as amended and restated on July 30, 2004 and further amended ten times between
October 22, 2004 and November 14, 2005, pursuant to which Toucan Capital agreed to recapitalize the
Company by making loans to the Company, the Company accrued and paid certain legal and other
administrative costs on Toucan Capitals behalf. Pursuant to the terms of the Conversion Agreement
discussed above, the recapitalization agreement was terminated on June 22, 2007. Subsequent to the
termination of the recapitalization agreement, Toucan Capital continues to incur costs on behalf of
the Company. These costs primarily relate to consulting costs and travel expenses incurred in
support of the Companys international expansion efforts. In addition, since July 1, 2007 the
Company has accrued and recorded rent expense due to Toucan Capital Corp. an affiliate of Toucan
Capital for its office space in Bethesda, Maryland.
During the years ending December 31, 2007 and 2006, respectively, the Company recognized
approximately $1.0 million and $1.4 million of general and administrative costs related to this
recapitalization agreement, rent expense, as well as legal, travel and other costs incurred by
Toucan Capital on the Companys behalf. Approximately $175,000 of the costs recorded in 2007 relate
to activities which took place prior to January 1, 2007. At December 31, 2007 and 2006, accrued
expense payable to Toucan Capital management amounted to $0.9 million and $0.3 million,
respectively, and are included in the accompanying consolidated balance sheets.
(7) Income Taxes
There was no income tax benefit attributable to net losses for 2005, 2006 and 2007. The
difference between taxes computed by applying the U.S. federal corporate rate of 34% and the actual
income tax provisions in 2005, 2006 and 2007 is primarily the result of establishing a valuation
allowance on the Companys deferred tax assets arising primarily from tax loss carry forwards.
The tax effects of temporary differences and tax loss and credit carry forwards that give rise
to significant portions of deferred tax assets at December 31 are comprised of the following (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005
|
|
|
2006
|
|
|
2007
|
|
Net operating loss carry forwards
|
|
$
|
20,450
|
|
|
$
|
22,354
|
|
|
$
|
25,327
|
|
Research and development credit carry forwards
|
|
|
1,525
|
|
|
|
1,533
|
|
|
|
2,011
|
|
Depreciation and amortization
|
|
|
927
|
|
|
|
1,134
|
|
|
|
|
|
Other
|
|
|
325
|
|
|
|
357
|
|
|
|
397
|
|
|
|
|
|
|
|
|
|
|
|
Gross deferred tax assets
|
|
|
23,227
|
|
|
|
25,378
|
|
|
|
27,735
|
|
Less valuation allowance
|
|
|
(23,227
|
)
|
|
|
(25,378
|
)
|
|
|
(27,735
|
)
|
|
|
|
|
|
|
|
|
|
|
Net deferred tax assets
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in the valuation allowance for deferred tax assets for 2005, 2006 and 2007 of
$3.5 million, $2.2 million and $2.4 million, respectively, was due to the inability to utilize net
operating losses and research and development credits.
At December 31, 2007, the Company had net operating loss carry forwards for income tax
purposes of approximately $74.5 million and unused research and development tax credits of
approximately $2.0 million available to offset future taxable income and income taxes,
respectively, expiring beginning 2018 through 2024. The Companys ability to utilize net operating
loss and credit carry forwards is limited pursuant to the Tax Reform Act of 1986, due to cumulative
changes in stock ownership in excess of 50% such that some net operating losses may never be
utilized.
(8) Scientific Collaboration Arrangements
The Company has also entered into certain collaborative arrangements under which it may be
obligated to pay royalties or milestone payments if product development is successful. It is not
anticipated that the aggregate amount of any royalty or milestone obligations under these other
arrangements will be material to the Companys operations.
F-24
(9) Commitments and Contingencies
(a) Lease Obligations
The Company leases its facilities. As of December 31, 2007, the Company does not have any
remaining capital leases. Commitments for minimum rentals under non-cancelable leases in effect as
of December 31, 2007 are as follows (in thousands):
|
|
|
|
|
|
|
Operating
|
|
|
Leases
|
Rent agreements
|
|
$
|
19
|
|
Rent expense was approximately $96,000, $37,000 and $260,000 in 2005, 2006 and 2007,
respectively.
(b) Purchase Commitments
As of December 31, 2007, the Company has entered into the following contractual obligations:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period
|
|
|
|
|
|
|
|
Less Than
|
|
|
|
|
|
|
|
|
|
|
More than
|
|
Contractual Obligation(1)
|
|
Total
|
|
|
1 Year
|
|
|
1-3 Years
|
|
|
3-5 Years
|
|
|
5 Years
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contract Manufacturing by Related Party(2)
|
|
$
|
9,900,000
|
|
|
$
|
6,600,000
|
|
|
$
|
3,300,000
|
|
|
$
|
|
|
|
$
|
|
|
Purchase Obligations
|
|
|
327,857
|
|
|
|
327,857
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
10,227,857
|
|
|
$
|
6,927,857
|
|
|
$
|
3,300,000
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
|
The Company has also entered into other collaborative arrangements
under which it may be obligated to pay royalties or milestone payments
if product development is successful. We do not anticipate that the
aggregate amount of any royalty or milestone obligations under these
arrangements will be material.
|
|
(2)
|
|
The agreement has been entered for an initial two year period and is
subject to quarterly true-ups. The Company may terminate this contract
manufacturing agreement with 180 days notice and payment of all
reasonable wind-up costs and Cognate may terminate the contract in the
event that the brain cancer clinical trial fails to complete
enrollment by July 1, 2009. However, if such termination by the
Company occurs at any time prior to the earlier of the submission of
an FDA biological license application/new drug application on the
Companys brain cancer clinical trial or July 1, 2010 or, such
termination by Cognate results from failure of the brain cancer
clinical trial to complete patient enrollment by July 1, 2009, the
Company is obligated to make an additional termination fee payment to
Cognate equal to $2 million.
|
(c) Legal Matters
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 the Company 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 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.
F-25
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 with 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.
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. On June 19, 2007, the Appellate Division, First Department of the Supreme
Court of the State of New York, reversed the December 30, 2005 decision and ordered a new
arbitration proceeding. On July 26, 2007, we filed a Motion for Leave to Appeal with the Court of
Appeals of the State of New York and on August 3, 2007 Soma filed its reply brief. On October 16,
2007, the Court of Appeals of the State of New York denied our motion to appeal. We intend to
continue to vigorously defend ourselves against the claims of Soma.
Lonza Patent Infringement Claim
On July 27, 2007, Lonza Group AG (Lonza) filed a complaint against us in the United States
District Court for the District of Delaware alleging patent infringement relating to recombinant
DNA methods, sequences, vectors, cell lines and host cells. The complaint sought temporary and
permanent injunctions enjoining us from infringing Lonzas patents and unspecified damages. On
November 27, 2007, the complaint was dismissed from the United States District Court for the
District of Delaware. Also on November 27, 2007, a new complaint was filed by Lonza in the United
States District Court for the District of Maryland. The new complaint alleged the same patent
infringement relating to recombinant DNA methods, sequences, vectors, cell lines and host cells by
the Companys DCVax®. We believe that Lonzas remaining claims are meritless and intend
to vigorously defend this action. On December 13, 2007 Lonza in two new claims relating to all of
our products other than DCVax® Prostate.
Stockholder Class Action Lawsuits
On August 13, 2007, a complaint was filed in the U.S. District Court for the Western District
of Washington naming the Company, the Chairperson of its Board of Directors, Linda F. Powers, and
its Chief Executive Officer, Alton L. Boynton, as defendants in a class action for violation of
federal securities laws. After this complaint was filed, five additional complaints were filed in
other jurisdictions alleging similar claims. The complaints were filed on behalf of purchasers of
the Companys common stock between July 9, 2007 and July 18, 2007 and allege violations of Section
10(b) of the Exchange Act and Rule 10b-5 thereunder. The complaints seek unspecified compensatory
damages, costs and expenses. We dispute these claims and intend to vigorously defend these actions.
On December 18, 2007, a consolidated complaint was filed in the U.S. District Court for the
Western District of Washington consolidating the Shareholder actions previously filed.
SEC Inquiry
On August 13, 2007, we were notified that the SEC had initiated a non-public informal inquiry
regarding the events surrounding our application for Swiss regulatory approval and related press
releases dated July 9, 2007 and July 16, 2007. On March 3, 2008 the Company was notified that the
SEC had initiated a formal investigation regarding this matter. We have been co-operating with the
SEC in connection with the inquiry, and will continue to do so.
F-26
Management Warrants
On November 13, 2003, we borrowed an aggregate of $335,000 from certain members of our
management. As part of the consideration for this loan, the lenders received warrants exercisable
to acquire an aggregate of 0.25 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 630,000 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, in the event such claims are pursued, we intend to vigorously defend against them.
We have no other legal proceedings pending at this time.
(d) Sales Tax Assessment
The Company received a tax assessment of $492,000 on October 21, 2003 related to the
abandonment of tenant improvements at a facility it had previously leased on which use tax payments
to the State of Washington had been deferred, including the disposal and impairment of previously
qualified tax deferred equipment. The Company appealed this assessment and was granted a partial
reduction in the assessment on July 8, 2005. The Company filed an addendum to its appeal petition
on December 2, 2005. The net assessment, through December 31, 2005, of approximately $336,000,
inclusive of accrued interest, was being carried as an estimated liability on the Companys balance
sheet and included in general and administrative expense. On August 10, 2006, the Companys appeal
was denied. In September 2006, the Company entered into an agreement with the State of Washington
to pay an aggregate of approximately $336,000, plus interest at a rate of 4% per year over a four
month period commencing on September 11, 2006. As of December 31, 2006, the Company has repaid the
outstanding balance.
In February 2004, the Company filed a refund request of approximately $175,000 related to
certain other state taxes previously paid to the State of Washingtons Department of Revenue. As of
December 31, 2006, we have received correspondence from the Department of Revenue setting forth a
refund of approximately $36,000. The refund was received and recorded in general and administrative
during the year ended December 31, 2007. We do not plan to pursue this matter any further.
(10) Notes Payable
(a) Notes Payable to Related Parties.
Commencing in November 2003, the Company issued promissory notes to finance its operations.
This debt financing is comprised of convertible management loans, senior convertible promissory
notes issued to Toucan Capital and Toucan Partners, as well as further cash advances from Toucan
Partners. In April 2007, these cash advances were converted into a new series of convertible
promissory notes (and associated warrants). In addition, the convertible promissory notes
previously issued to Toucan Partners with an aggregate value of $950,000 were amended and restated
to conform to the terms of the new notes and warrants. Although these notes are convertible the
conversion terms will not be fixed until a future date upon further negotiation between the Company
and Toucan Partners. As of December 31, 2007, all notes payable to related parties have been
repaid.
The related party notes payable transactions are more fully described in note (2) Operations
and Financing.
Management Loans
In November 2003, the Company issued convertible promissory notes totaling $335,000 to certain
members of management as more fully described in note (2) Operations and Financing.
Toucan Capital Loans
From February 1, 2004 through September 7, 2005, the Company issued thirteen promissory notes
to Toucan Capital pursuant to which Toucan Capital loaned the Company an aggregate of $6.75 million
in bridge loan financing as more fully described in note (2) Operations and Financing.
F-27
Toucan Partners Loans
From November 14, 2005 through December 31, 2007, the Company issued 15 promissory notes to
Toucan Partners pursuant to which Toucan Partners loaned the Company an aggregate of $4,825,000 in
loan financing. These notes were fully repaid as of December 31, 2007. These transactions are more
fully described in note (2) Operations and Financing.
From November 14, 2005 through March 9, 2006, the Company issued three promissory notes and
associated warrants to Toucan Partners pursuant to which Toucan Partners 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 described below. Payment was due under the notes upon written
demand on or after June 30, 2007. Interest accrued 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 into common stock on the same terms as the 2007 Convertible Notes.
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 was amortized over the original twelve-month term of the respective notes.
From October 2006 through April 2007, the Company received 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), the 2007 Convertible Notes and 2007 Warrants, respectively, that accrue interest at 10%
per annum from their respective original cash advance dates; however, the conversion terms of these
notes and the exercise price of these warrants were not fixed. On June 1, 2007, the Company and
Toucan Partners amended the 2007 Convertible Notes and 2007 Warrants to specify and fix the
conversion and exercise prices thereof. The Company and Toucan Partners also entered into two new
promissory notes to fix the terms of the two additional cash advances provided by Toucan Partners
to the Company on May 14, 2007 and May 25, 2007 in the aggregate amount of $725,000, and issued
warrants to purchase shares of the Companys capital stock to Toucan Partners in connection with
each such note. These notes and warrants have the same terms as the 2007 Convertible Notes and 2007
Warrants. As amended, the 2007 Convertible Notes provided that the principal and interest thereon
was convertible into shares of the Companys Series A-1 Preferred Stock at the conversion price of
$1.60 per share, (with each such share of Series A-1 Preferred Stock convertible into 2.67 shares
of Common Stock at $0.60 per share) or, at the election of Toucan Partners, any other equity
security of the Company (at a conversion price of $0.60 per share). As amended, the 2007 Warrants
provided that they were exercisable for shares of Series A-1 Preferred Stock at the exercise price
of $1.60 per share (with each such share of Series A-1 Preferred Stock convertible into 2.67 shares
of Common stock at $0.60 per share) or, at the election of Toucan Partners, any other equity
security of the Company (at an exercise price of $0.60 per share). Each of the 2007 Warrants is
exercisable for the same number of shares that the corresponding 2007 Convertible Note is
convertible into at the time of exercise or, if earlier, the date on which the corresponding 2007
Convertible Note is either converted or repaid in full.
In recognition of the modification to the 2007 Convertible Notes and 2007 Warrants, the
aggregate proceeds of $3,875,000 received from Toucan Partners between October 2006 and May 2007
and the aggregate proceeds of $950,000 received from Toucan Partners between November 14, 2005 and
March 9, 2006 were reallocated between the notes (including accrued interest) and warrants on a
relative fair value basis as of June 1, 2007. The value allocated to the warrants on the date of
the modification was approximately $3.7 million. The fair value of the warrants was determined
using the Black-Scholes option pricing model with the following assumptions: expected dividend
yield of 0%, risk-free interest rate of 4.9%, volatility of 240%, and a contractual life of 7
years. The value of the warrants was recorded as a deferred debt discount against the $4.825
million proceeds (plus accrued interest) of the notes. In addition, a beneficial conversion feature
related to the notes was determined to be approximately $1.4 million. As a result, the total
discount on the notes (including accrued interest) equaled $5.1 million which has been expensed in
its entirety in June 2007 in recognition of the June 30, 2007 maturity date of the respective
notes. Interest expense on the notes of approximately $363,000 and $324,000 was recorded for the
years ended December 31, 2007 and 2006, respectively.
F-28
Pursuant to the terms of the Conversion Agreement discussed in Note 2 above, which became
effective on June 22, 2007, Toucan Partners agreed to eliminate all of its existing rights to
receive Series A-1 Preferred Stock in connection with the 2007 Convertible Notes and 2007 Warrants
(and thereafter to receive shares of Common Stock at $0.60 per share rather than shares of Series
A-1 Preferred Stock at $1.60 per share), and the rights, preferences and protections associated
with the Series A-1 Preferred Stock, including the liquidation preference that would entitle Toucan
Partners to certain substantial cash payments, in return for the issuance by the Company of
2,572,710 shares of Common Stock.
At December 31, 2007, the principal and cumulative interest balance of the 2007 Convertible
Notes has been fully repaid. Toucan Partners holds warrants related to these notes which are
convertible into 8,832,541 shares of Common Stock at $0.60 per share.
(11) Unaudited Quarterly Financial Information (in thousands, except loss per share data)
The following table contains selected unaudited statement of operations information for each
of the quarters in 2005, 2006 and 2007. The Company believes that the following information
reflects all adjustments, consisting of only normal recurring adjustments, necessary for a fair
presentation of the information for the periods presented. The operating results for any quarter
are not necessarily indicative of results for any future period.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First
|
|
Second
|
|
Third
|
|
Fourth
|
|
|
Quarter
|
|
Quarter
|
|
Quarter
|
|
Quarter
|
|
|
2005
|
|
2005
|
|
2005
|
|
2005
|
Total revenues
|
|
$
|
87
|
|
|
$
|
8
|
|
|
$
|
15
|
|
|
$
|
14
|
|
Net loss applicable to common stockholders
|
|
$
|
(2,526
|
)
|
|
$
|
(2,638
|
)
|
|
$
|
(2,782
|
)
|
|
$
|
(1,987
|
)
|
Net loss per share applicable to common stockholders basic and diluted
|
|
$
|
(1.95
|
)
|
|
$
|
(2.10
|
)
|
|
$
|
(2.25
|
)
|
|
$
|
(1.50
|
)
|
Weighted average shares used in computing basic and diluted loss per share
|
|
|
1,269
|
|
|
|
1,272
|
|
|
|
1,272
|
|
|
|
1,272
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First
|
|
Second
|
|
Third
|
|
Fourth
|
|
|
Quarter
|
|
Quarter
|
|
Quarter
|
|
Quarter
|
|
|
2006
|
|
2006
|
|
2006
|
|
2006
|
Total revenues
|
|
$
|
|
|
|
$
|
|
|
|
$
|
80
|
|
|
$
|
|
|
Net income (loss) applicable to common stockholders
|
|
$
|
(3,958
|
)
|
|
$
|
6,428
|
|
|
$
|
(1,809
|
)
|
|
$
|
(2,057
|
)
|
Net income (loss) per share applicable to common stockholders basic
|
|
$
|
(3.15
|
)
|
|
$
|
1.50
|
|
|
$
|
(0.45
|
)
|
|
$
|
(0.45
|
)
|
Net income (loss) per share applicable to common stockholders diluted
|
|
$
|
(3.15
|
)
|
|
$
|
0.45
|
|
|
$
|
(0.45
|
)
|
|
$
|
(0.45
|
)
|
Weighted average shares used in computing basic income (loss) per share
|
|
|
1,282
|
|
|
|
4,225
|
|
|
|
4,349
|
|
|
|
4,349
|
|
Weighted average shares used in computing diluted income (loss) per share
|
|
|
1,282
|
|
|
|
15,234
|
|
|
|
4,349
|
|
|
|
4,349
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First
|
|
Second
|
|
Third
|
|
Fourth
|
|
|
Quarter
|
|
Quarter
|
|
Quarter
|
|
Quarter
|
|
|
2007
|
|
2007
|
|
2007
|
|
2007
|
Total revenues
|
|
$
|
|
|
|
$
|
|
|
|
$
|
10
|
|
|
$
|
|
|
Net loss applicable to common stockholders
|
|
$
|
(1,952
|
)
|
|
$
|
(44,918
|
)
|
|
$
|
(3,909
|
)
|
|
$
|
(7,431
|
)
|
Net loss per share applicable to common stockholders basic and diluted
|
|
$
|
(0.45
|
)
|
|
$
|
(5.56
|
)
|
|
$
|
(0.09
|
)
|
|
$
|
(0.18
|
)
|
Weighted average shares used in computing basic and diluted loss per share
|
|
|
4,349
|
|
|
|
8,074
|
|
|
|
42,298
|
|
|
|
42,346
|
|
(12) Impairment and Disposal of Long-lived Assets
The Company vacated its prior 5,045 square foot facility when signing a new sublease on
November 4, 2005, and moving to a smaller administrative only facility of 2,325 square feet on
December 31, 2005. The Company sold, disposed, or impaired $159,000 of fixed assets and leasehold
improvements, in the third and fourth quarters of 2005, recognizing a loss on retirement of fixed
assets of approximately $41,000, net of depreciation, and cash received of approximately $97,000,
the net of which is included in general and administrative expenses as of December 31, 2005.
F-29
(13) Subsequent Events
On March 21, 2008, the Company executed a Sublease Agreement (the Sublease Agreement) with
Toucan Capital Corporation for the space the Company uses as its headquarters at 7600 Wisconsin
Avenue, Suite 750, Bethesda, Maryland. The Sublease Agreement is effective as of July 1, 2007 and
expires on October 31, 2016, unless sooner terminated according to its terms. Previously, the
Company had been occupying its Bethesda headquarters under an oral arrangement with Toucan Capital
Corporation, whereby the Company was required to pay base rent of $32,949.10 per month through
December 31, 2007. Under the Sublease Agreement, the Company is required to pay base rent of
$34,000 per month during the year 2008, which monthly amount increases by $1,000 on an annual
basis, to a maximum of $42,000 per month during 2016, the last year of the lease term. In addition
to monthly base rent, the Company was and remains obligated to pay operating expenses allocable to
the subleased premises under Toucan Capital Corporations master lease.
F-30
SIGNATURES
679,389 Shares
Common Stock
Northwest Biotherapeutics, Inc.
PROSPECTUS
April ___, 2008
PART II
INFORMATION NOT REQUIRED IN THE PROSPECTUS
Item 13.
Other Expenses of Issuance and Distribution.
Set forth below are the expenses expected to be incurred in connection with the issuance and
distribution of the securities registered hereby. With the exception of the Securities and Exchange
Commission (SEC) registration fee, the amounts set forth below are estimates.
|
|
|
|
|
|
|
Amount
|
|
|
|
|
|
|
SEC Registration Fee
|
|
$
|
2,430
|
|
Printing Expenses
|
|
$
|
75,000
|
|
Accounting Fees and Expenses
|
|
$
|
48,000
|
|
Legal Fees and Expenses
|
|
$
|
160,000
|
|
Blue Sky Fees and Expenses
|
|
$
|
3,000
|
|
Miscellaneous
|
|
$
|
|
|
|
|
|
|
Total
|
|
$
|
288,430
|
|
|
|
|
|
Item 14.
Indemnification of Directors and Officers.
Section 145(a) of the Delaware General Corporation Law (DGCL) provides in relevant part that
"[a] corporation shall have the power to indemnify any person who was or is a party or is
threatened to be made a party to any threatened, pending or completed action, suit or proceeding,
whether civil, criminal, administrative or investigative (other than an action by or in the right
of the corporation) by reason of the fact that the person is or was a director, officer, employee
or agent of the corporation, or is or was serving at the request of the corporation as a director,
officer, employee or agent of another corporation, partnership, joint venture, trust or other
enterprise, against expenses (including attorneys fees), judgments, fines and amounts paid in
settlement actually and reasonably incurred by the person in connection with such action, suit or
proceeding if the person acted in good faith and in a manner the person reasonably believed to be
in or not opposed to the best interests of the corporation, and, with respect to any criminal
action or proceeding, had no reasonable cause to believe the persons conduct was unlawful. With
respect to derivative actions, Section 145(b) of the DGCL provides in relevant part that [a]
corporation shall have the power to indemnify any person who was or is a party or is threatened to
be made a party to any threatened, pending or completed action or suit by or in the right of the
corporation to procure a judgment in its favor ... [by reason of the persons service in one of the
capacities specified in the preceding sentence] against expenses (including attorneys fees)
actually and reasonably incurred by the person in connection with the defense or settlement of such
action or suit if he acted in good faith and in a manner the person reasonably believed to be in or
not opposed to the best interest of the corporation except that no indemnification shall be made in
respect of any claim, issue or matter as to which such person shall have been adjudged to be liable
to the corporation unless and only to the extent that the Court of Chancery or the court in which
such action or suit was brought shall determine upon application that, despite the adjudication of
liability but in view of all the circumstances of the case, such person is fairly and reasonably
entitled to indemnity for such expenses which the Court of Chancery or such other court shall deem
proper.
Our Certificate of Incorporation includes a provision that eliminates the personal liability
of our directors for monetary damages for breach of fiduciary duty to the full extent permitted by
Delaware law.
Our Bylaws provide that the Company is required to indemnify and hold harmless its directors
and officers and may indemnify and hold harmless its employees and agents, in any threatened,
pending or completed action, suit or proceeding, whether civil, criminal, administrative or
investigative (other than an action by or in the right of the Company) by reason of any action
alleged to have been taken or omitted in such capacity, against costs, charges, expenses (including
counsel fees), judgments, fines and amounts paid or owed in settlement actually and reasonably
incurred by such person or rendered or levied against such person in connection with such action,
suit or proceeding, if the party being indemnified acted in good faith and in a manner such party
reasonably believed to be in or
not opposed to the best interests of the Company, and, with respect to any criminal action or
proceeding, had no reasonable cause to believe such partys conduct was unlawful. In proceedings by
or in the right of the Company, a party seeking to be indemnified may be indemnified if the above
standards of conduct are met and to the extent as set forth above, however, if a court judges a
party seeking to be indemnified liable to the corporation, no indemnification shall be provided
except to the extent that, in view of all of the circumstances of the case, such person is fairly
and reasonably entitled to indemnification. To the extent that a director, officer, employee or
agent of the Company has been successful on the merits or otherwise, including without limitation,
the dismissal of an action without prejudice, in defense of any action, suit or proceeding, or in
defense of any claim, issue or matter therein, such party shall be indemnified against all costs,
charges and expenses (including counsel fees) actually and reasonably incurred in connection
therewith.
II-1
We maintain insurance on behalf of our officers and directors, insuring them against
liabilities that they may incur in such capacities or arising out of this status.
The above discussion of our Certificate of Incorporation and Bylaws and of Section 145 of the
DGCL is not intended to be exhaustive and is respectively qualified in its entirety by such
Certificate of Incorporation, Bylaws and statute.
See also the undertakings included under Item 17 in this registration statement.
Item 15.
Recent Sales of Unregistered Securities.
The Company sold the securities described below during the past three years (from the date
hereof) without being registered under the Securities Act. (All common per share amounts have been
adjusted to reflect the June 19, 2007 one-for-fifteen reverse stock split.)
1. The Company sold an aggregate of 9,007 shares of common stock to employees, directors and
consultants for cash consideration in the aggregate amount of $11,100 upon the exercise of stock
options and stock awards.
2. The Company granted stock options and stock awards to employees, directors and
consultants under its 1998 Stock Plan, 1999 Executive Stock Plan, 2001 Stock Plan, 2001
Nonemployee Director Stock Incentive Plan and Employee Stock Purchase Plan covering an aggregate
of 25,667 shares of common stock, with exercise prices ranging from $1.80 to $3.15 per share. Of
these, options covering an aggregate of 12,333 were cancelled without being exercised.
3. On November 13, 2003, the Company borrowed an aggregate of $335,000 from members of its
management, pursuant to a series of convertible promissory notes which accrued interest at a rate
of prime plus 2% (and associated warrants to purchase an aggregate of approximately 0.25 million shares of our common stock at $0.60 per share). In connection with the financing with Toucan
Capital Fund II, L.P. (Toucan Capital) described below, the remaining $285,000 principal amount
of notes were amended to, among other things, reduce the conversion prices to $1.50 per share.
The notes that remained outstanding were amended on a number of occasions to extend their
respective maturity dates.
From March 2006 through June 2006, these warrants were exercised on a net exercise basis for
an aggregate of 230,647 shares. Additionally, in March 2006, the promissory notes referred to
above, including all accrued interest thereon, were converted in accordance with their terms into
an aggregate of 179,181 shares of common stock.
4. Since 2004, the Company has undergone a significant recapitalization pursuant to which
Toucan Capital loaned the Company an aggregate of $6.75 million and Toucan Partners, LLC, an
affiliate of Toucan Capital (Toucan Partners), loaned the Company an aggregate of $4.825
million (excluding $225,000 in proceeds from a demand note that was received on June 13, 2007 and
repaid on June 27, 2007).
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 cumulative
convertible preferred stock (the 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, the $6.75 million of notes payable plus all accrued interest due to
Toucan Capital were converted into shares of the Companys Series A-1 cumulative convertible
Preferred Stock (the Series A-1 Preferred Stock).
II-2
The $4.825 million loaned to the Company by Toucan Partners was loaned in a series of
transactions. From November 14, 2005 through March 9, 2006, the Company issued three promissory
notes to Toucan Partners, pursuant to which Toucan Partners loaned the Company an aggregate of
$950,000. In April 2007, these notes were amended and restated to conform to the 2007 Convertible
Notes described below. Interest accrued at 10% per annum, compounded annually, on a 365-day year
basis.
In addition to the $950,000 of promissory notes described above, Toucan Partners provided $3.15
million in cash advances from October 2006 through April 2007, which were converted into
convertible notes (the 2007 Convertible Notes) and related warrants (the 2007 Warrants) in
April 2007. The Company and Toucan Partners also entered into two promissory notes to fix the
terms of two additional cash advances provided by Toucan Partners to the Company on May 14, 2007
and May 25, 2007 in the aggregate amount of $725,000, and issued warrants to purchase shares of
the Companys capital stock to Toucan Partners in connection with each such note. These notes and
warrants are on the same terms as the previous 2007 Convertible Notes and 2007 Warrants.
During October through December 2007, the Company fully repaid $5.3 million in principal and
related accrued interest due to Toucan Capital pursuant to the $4.825 million Convertible Notes.
On June 1, 2007, the Company issued to Toucan Capital a new warrant to purchase the
Companys Series A-1 Preferred Stock (Toucan Capital Series A-1 Warrant) in exchange for the
cancellation of all previously issued warrants to purchase Series A-1 Preferred Stock (or, at the
election of Toucan Capital, any other equity or debt security of the Company) held by Toucan
Capital. The new Toucan Capital Series A-1 Warrant is exercisable for 6,471,333 shares of Series
A-1 Preferred Stock plus shares of Series A-1 Preferred Stock attributable to accrued dividends
on the shares of Series A-1 Preferred Stock held by Toucan Capital, (with each such Series A-1
Preferred Share convertible into 2.67 shares of common stock at $0.60 per share), as compared to
the 3,062,500 shares of Series A-1 Preferred Stock (with each such Series A-1 Preferred Share
convertible into 2.67 shares of common stock at $0.60 per share) that were previously issuable to
Toucan Capital upon exercise of the warrants being cancelled.
Also on June 1, 2007, the Company and Toucan Capital amended Toucan Capitals warrant to
purchase Series A Preferred Stock (the Toucan Capital Series A Warrant) to increase the number
of shares of Series A Preferred Stock that are issuable upon exercise of the warrant to
32,500,000 shares of Series A Preferred Stock (plus shares of Series A Preferred Stock
attributable to accrued dividends on the shares of Series A Preferred Stock held by Toucan
Capital) from 13,000,000 shares of Series A Preferred Stock.
On June 15, 2007, the Company, Toucan Capital, and Toucan Partners entered into a conversion
agreement (Conversion Agreement) which became effective on June 22, 2007 upon the admission of
the Companys common stock to trade on the Alternative Investment Market (AIM) of the London
Stock Exchange (Admission).
Pursuant to the terms of the Conversion Agreement (i) Toucan Capital agreed to convert and
has converted all of its shares of the Companys Series A Preferred Stock and Series A-1
Preferred Stock (in each case, excluding any accrued and unpaid dividends) into common stock and
agreed to eliminate a number of rights, preferences and protections associated with the Series A
Preferred Stock and Series A-1 Preferred Stock, including the liquidation preference entitling
Toucan Capital to certain substantial cash payments and (ii) Toucan Partners agreed to eliminate
all of its existing rights to receive Series A-1 Preferred Stock under certain notes and warrants
(and thereafter to receive shares of common stock rather than shares of Series A-1 Preferred
Stock), and the rights, preferences and protections associated with the Series A-1 Preferred
Stock, including the liquidation preference that would entitle Toucan Partners to certain
substantial cash payments, in return for issuance by the Company of an aggregate of 6,860,561
additional shares of common stock, to be apportioned between Toucan Capital and Toucan Partners
as to 4,287,851 and 2,572,710 shares of common stock, respectively.
Following conversion by Toucan Capital of all of its shares of the Companys Series A
Preferred Stock and Series A-1 Preferred Stock, no shares of either series of preferred stock
remained outstanding. Accordingly, as approved by the board of directors of the Company, upon
Admission on June 22, 2007, the Company filed with the Secretary of State of the State of
Delaware a Certificate of Elimination of the Companys Series A Cumulative Convertible Preferred
Stock and a Certificate of Elimination of the Companys Series A-1 Cumulative Convertible
Preferred Stock, to eliminate the Companys Series A Preferred Stock and Series A-1 Preferred
Stock, respectively. In addition, under the terms of the Conversion Agreement (i) the Toucan
Capital Series A Warrant is exercisable for 2,166,667 shares of common stock rather than shares
of Series A Preferred Stock (plus shares of common stock, rather than shares of Series A Preferred Stock, attributable to
accrued dividends on the shares of Series A Preferred Stock previously held by Toucan Capital
that were converted into common stock upon Admission, subject to the further provisions of the
Conversion Agreement as described below) and (ii) the Toucan Capital Series A-1 Warrant is
exercisable for an aggregate of 17,256,888 shares of common stock rather than shares of Series
A-1 Preferred Stock (plus shares of common stock, rather than shares of Series A-1 Preferred
Stock, attributable to accrued dividends on the shares of Series A-1 Preferred Stock previously
held by Toucan Capital that were converted into common stock upon Admission), subject to further
provisions of the Conversion Agreement as described below.
II-3
As noted above, the 32,500,000 shares of Series A Preferred Stock held by Toucan Capital
converted, in accordance with their terms, into 2,166,667 shares of common stock and the
4,816,863 shares of Series A-1 Preferred Stock held by Toucan Capital converted, in accordance
with their terms, into 12,844,968 shares of common stock, and the convertible promissory notes
issued by the Company to Toucan Partners in aggregate principal amount of $4.825 million (the
2007 Convertible Notes) and associated warrants (the 2007 Warrants) became convertible and
exercisable solely for shares of common stock.
Under the terms of the Conversion Agreement, Toucan Capital also agreed to temporarily defer
receipt of the accrued and unpaid dividends on its shares of Series A Preferred Stock and Series
A-1 Preferred Stock of an amount equal to $334,340 and $917,451, respectively, until not later
than September 30, 2007. We paid these dividends in full to Toucan Capital in September 2007.
5. In April 2006, the Company sold 2,631,193 shares of common stock (and accompanying
warrants to purchase an aggregate of 1,315,596 shares of common stock at an exercise price of
$2.10 per share) to certain accredited investors (the PIPE Financing) for aggregate proceeds of
approximately $5.5 million.
6. On April 7, 2006, the Company issued 32,139 shares of its common stock to an accredited
investor as a result of the net exercise of the warrant to purchase 47,619 shares of common stock
at $2.10 per share acquired by such investor pursuant to the PIPE Financing.
7. On June 22, 2007, the Company placed 15,789,473 shares of its common stock with foreign
institutional investors at a price of £0.95 per share. The gross proceeds from the placement were
approximately £15.0 million, or $29.9 million, while net proceeds from the offering, after
deducting commissions and expenses, were approximately £13.0 million, or $25.9 million.
8. From July 11 through 16, 2007, the Company issued 335,097 shares of its common stock to
accredited investors as a result of the net exercise of warrants to purchase 255,463 shares of
common stock at $2.10 per share acquired by such investors pursuant to the PIPE Financing.
9. During fourth quarter 2007, the Company granted stock options to employees under its 2007
Stock Option Plan covering an aggregate of 4,724,462 shares of common stock, with exercise prices
ranging from $0.60 to $2.40 per share.
10. On April 7, 2008, the Company
granted stock options to employees under its 2007 Stock Option Plan
covering an aggregate of 720,000 shares of common stock, with
exercise prices ranging from $2.00 to $2.40 per share.
The Company claimed exemption from registration under the Securities Act for the sales and
issuances of securities in the transactions described in paragraphs
(1), (2), (9) and (10) above under
Section 4(2) of the Securities Act in that such sales and issuances did not involve a public
offering, or under Rule 701 under the Securities Act, in that they were offered and sold either
pursuant to written compensatory plans or pursuant to a written contract relating to compensation,
as provided by Rule 701.
The Company claimed exemption from registration under the Securities Act for the sale and
issuance of securities in the transactions described in paragraphs (3), (4) and (5) under Section
4(2) of the Securities Act and/or Regulation D thereunder, as transactions not involving any public
offering. All of the purchasers of unregistered securities for which the Company relied on Section
4(2) and/or Regulation D represented that they were accredited investors, as defined under the
Securities Act. The Company claimed such exemption on the basis that (i) the purchasers in each
case represented that they intended to acquire the securities for investment only and not with a
view to the distribution thereof and that they either received adequate information about the
Company or had access, through employment or other relationships, to such information and (ii)
appropriate legends were affixed to the stock certificates or warrants issued in such transactions.
II-4
The Company claimed exemption from registration under the Securities Act for the sale and
issuance of securities in the transactions described in paragraphs (3), (6), and (8) pursuant to
Section 3(a)(9) of the Securities Act, as an exchange of securities where no commission or other
remuneration is paid or given directly or indirectly for soliciting the exchange.
Item 16.
Exhibits and Financial Statement Schedules
(a) The following documents are filed as exhibits to this registration statement:
EXHIBIT INDEX
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Exhibit
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Number
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Description
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3.1
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Seventh Amended and Restated Certificate of Incorporation (3.1)(22).
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3.2
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Third Amended and Restated Bylaws of the Company (3.1)(29).
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3.3
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Amendment to Seventh Amended and Restated Certificate of Incorporation (3.2)(29).
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3.4
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Amendment to Seventh Amended and Restated Certificate of Incorporation. (3.4)(33)
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4.1
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Form of common stock certificate.(4.1)(2)
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4.2
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Northwest Biotherapeutics, Inc. Stockholders Rights Agreement dated February 26,
2002 between the Company and Mellon Investors Services, LLC.(4.2)(3)
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4.3
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Form of Rights Certificate.(4.1)(3)
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4.4
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Amendment to Northwest Biotherapeutics, Inc. Stockholders Rights Agreement dated
April 26, 2004.(4.2)(4)
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5.1****
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Opinion of Covington & Burling LLP as to the legality of the securities being
registered.
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10.1
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Amended and Restated Loan Agreement and 10% Promissory Note dated November 14,
2005 in the principal amount of $400,000 as amended and restated on April 14,
2007 between the Company and Toucan Partners, LLC.(10.1)(23)
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10.2
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Second Amended and Restated Loan Agreement and 10% Promissory Note originally
dated December 30, 2005, and amended and restated on April 17, 2006 and April
14, 2007 in the principal amount of $250,000 between the Company and Toucan
Partners, LLC.(10.2)(23)
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10.3
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Second Amended and Restated Loan Agreement and 10% Promissory Note originally
dated March 9, 2006, and as amended and restated on April 17, 2006 and April 14,
2007 in the principal amount of $300,000 between the Company and Toucan
Partners, LLC.(10.3)(23)
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10.4
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Form of Loan Agreement and 10% Convertible, Promissory Note between the Company
and Toucan Partners, LLC. (10.4)(23)
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10.5
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Amended and Restated Investor Rights Agreement dated April 17, 2006.(10.4)(18)
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10.6
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Second Amended and Restated Investor Rights Agreement dated June 22, 2007
between the Company and Toucan Capital Fund II, LLP (10.3)(29).
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II-5
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Exhibit
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Number
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Description
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10.7
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Securities Purchase Agreement, dated March 30, 2006 by and among the Company and
the Investors identified therein.(10.1)(6)
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10.8
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Form of Warrant.(10.2)(6)
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10.9
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Warrant to purchase securities of the Company dated April 26, 2004 issued to
Toucan Capital Fund II, L.P.(10.9)(7)
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10.10
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Warrant to purchase securities of the Company dated June 11, 2004 issued to
Toucan Capital Fund II, L.P.(10.8)(7)
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10.11
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Warrant to purchase securities of the Company dated July 30, 2004 issued to
Toucan Capital Fund II, L.P.(10.7)(7)
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10.12
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Warrant to purchase securities of the Company dated October 22, 2004 issued to
Toucan Capital Fund II, L.P.(10.3)(8)
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10.13
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Warrant to purchase securities of the Company dated November 10, 2004 issued to
Toucan Capital Fund II, L.P.(10.3)(9)
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10.14
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Warrant to purchase securities of the Company dated December 27, 2004 issued to
Toucan Capital Fund II, L.P.(10.3)(10)
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10.15
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First Amendment to Warrants between Northwest Biotherapeutics, Inc. and Toucan
Capital Fund II, L.P. dated January 26, 2005.(10.5)(1)
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10.16
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Warrant to purchase Series A Cumulative Convertible Preferred Stock dated
January 26, 2005 issued to Toucan Capital Fund II, L.P.(10.2)(1)
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10.17
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Warrant to purchase securities of the Company dated April 12, 2005 issued to
Toucan Capital Fund II, L.P.(10.39)(11)
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10.18
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Warrant to purchase securities of the Company dated May 13, 2005 issued to
Toucan Capital Fund II, L.P.(10.3)(12)
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10.19
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Warrant to purchase securities of the Company dated June 16, 2005 issued to
Toucan Capital Fund II, L.P.(10.3)(13)
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10.20
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Warrant to purchase securities of the Company dated July 26, 2005 issued to
Toucan Capital Fund II, L.P.(10.3)(14)
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10.21
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Warrant to purchase securities of the Company dated September 7, 2005 issued to
Toucan Capital Fund II, L.P.(10.3)(15)
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10.22
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Amended Form of Warrant to purchase securities of the Company dated November 14,
2005 and April 17, 2006, as amended April 14, 2007, issued to Toucan Partners,
LLC.(10.21)(23)
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10.23
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Form of Warrant to purchase securities of the Company dated April 14, 2007
issued to Toucan Partners, LLC.(10.22)(23)
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10.24
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Loan Agreement and 10% Convertible Promissory Note in the principal amount of
$100,000 between the Company and Toucan Partners, LLC, dated April 27, 2007
(10.1)(24).
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II-6
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Exhibit
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Number
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Description
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10.25
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Warrant to purchase securities of the Company issued to Toucan Partners, LLC.,
dated April 27, 2007 (10.2)(24).
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10.26
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Form of Toucan Partners Loan Agreement and 10% Convertible Note, dated as of
June 1, 2007 (10.1)(27).
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10.27
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Form of Toucan Partners Warrant, dated as of June 1, 2007 (10.2)(27).
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10.28
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Amended and Restated Warrant to Purchase Series A Preferred Stock issued to
Toucan Capital Fund II, L.P., dated as of June 1, 2007 (10.3)(27).
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10.29
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Warrant to Purchase Series A-1 Preferred Stock issued to Toucan Capital Fund II,
L.P., dated as of June 1, 2007 (10.4)(27).
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10.30
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Warrant to Purchase Series A-1 Preferred Stock issued to Toucan Capital Fund II,
L.P., dated as of June 1, 2007 (10.5)(27).
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10.31
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Northwest Biotherapeutics, Inc. $225,000 Demand Note dated June 13, 2007
(10.1)(28).
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10.32
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Conversion Agreement dated June 15, 2007 and effective June 22, 2007 between the
Company and Toucan Capital Fund II, LLP (10.1)(29).
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10.33
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Termination Agreement dated June 22, 2007 between the Company and Toucan Capital
Fund II, LLP (10.2)(29).
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10.34
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Nomad Agreement dated June 15, 2007 and effective June 22, 2007 between the
Company and Collins Stewart Europe Limited (10.4)(29).
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10.35***
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Employment Agreement dated June 18, 2007 between Dr. Alton L. Boynton and the
Company (10.6)(29).
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10.36***
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Employment Agreement dated October 1, 2007 between Anthony P. Deasey and the
Company (10.1)(30).
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10.37***
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Letter of Appointment for Linda F. Powers (10.8)(29).
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10.38***
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Letter of Appointment for R. Steve Harris (10.9)(29).
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10.39
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Form of Warrant to purchase common stock of the Company, as amended.(10.27)(18)
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10.40**
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Northwest Biotherapeutics DCVax®-Brain Services Agreement with Cognate
BioServices, Inc. dated May 17, 2007.(10.1)(25)
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10.41***
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1998 Stock Option Plan.(10.15)(2)
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10.42***
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1999 Executive Stock Option Plan.(10.16)(2)
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10.43***
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2001 Stock Option Plan.(10.17)(2)
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10.44***
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2001 Nonemployee Director Stock Incentive Plan.(10.18)(2)
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10.45***
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Employee Stock Purchase Plan.(10.19)(2)
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10.46***
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2007 Stock Option Plan (10.5)(29).
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10.47***
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Form of Stock Option Agreement under the 2007 Stock Option Plan. (10.2)(31)
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II-7
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Exhibit
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Number
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Description
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10.48
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Lease Agreement.(10.34)(18)
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10.49
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Lease Extension between the Company and the International Union of Operating
Engineers Local 302, dated May 31, 2007 (10.1)(26).
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10.50
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Clinical Study Agreement between the Company and the Regents of the University
of California dated February 14, 2006.(10.35)(18)
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10.51 ***
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Employment Agreement dated June 18, 2007 by and between Jim Johnston and the
Company. (10.7)(29)
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10.52 ***
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Form of Stock Option Agreement, dated December 31, 2007, by and between Dr.
Alton L. Boynton and the Company. (99.1)(32)
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10.53 ***
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Form of Stock Option Agreement, dated December 31, 2007, by and between Dr.
Marnix Bosch and the Company. (99.2)(32)
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10.54
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Sublease Agreement, dated as of March 21, 2008, between the Company and Toucan
Capital Corporation. (10.1)(34)
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11
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Computation of net loss per share included within the Northwest Biotherapeutics,
Inc. audited financial statements for the year ended December 31, 2006 included
in this Registration Statement on pages F-16 through F-43.
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21****
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Subsidiary of the registrant.
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23.1*
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Consent of Peterson Sullivan, PLLC, Independent Registered Accounting Firm.
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23.2
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Consent of Covington & Burling LLP, included in the opinion filed as Exhibit 5.1.
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(1)
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Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on February 1, 2005.
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(2)
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Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Amendment No. 3 to the Registration Statement on Form S-1 (File No. 333-67350) on
November 14, 2001.
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(3)
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Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Registration Statement on Form 8-A on July 8, 2002.
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(4)
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Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Annual Report on Form 10-K on May 14, 2004.
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(5)
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Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Quarterly Report on Form 10-Q on November 14, 2005.
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(6)
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Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on March 31, 2006.
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(7)
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Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on August 6, 2004.
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(8)
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Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on October 28, 2004.
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II-8
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(9)
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Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on November 16, 2004.
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(10)
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Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on December 30, 2004.
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(11)
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Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Annual Report on Form 10-K on April 15, 2005.
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(12)
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Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on May 18, 2005.
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(13)
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Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on June 21, 2005.
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(14)
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Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on August 1, 2005.
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(15)
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Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on September 9, 2005.
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(16)
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Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Quarterly Report on Form 10-Q on November 14, 2003.
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(17)
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Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on August 5, 2005.
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(18)
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Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Annual Report on Form 10-K on April 18, 2006.
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(19)
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Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on April 26, 2006.
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(20)
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Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Form 10-K/A on June 30, 2006.
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(21)
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Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrant Registration Statement on Form S-1 (File No. 33-134320) on May 19, 2006.
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(22)
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Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Amendment No. 1 to the Registration Statement on Form S-1(File No. 333-134320) on
July 17, 2006.
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(23)
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Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Form 10-K on April 17, 2007.
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(24)
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|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on May 3, 2007.
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(25)
|
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Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on May 21, 2007.
|
II-9
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(26)
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Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on June 4, 2007.
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(27)
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|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on June 7, 2007.
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(28)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on June 18, 2007.
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(29)
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Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on June 22, 2007.
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(30)
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Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on October 2, 2007.
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(31)
|
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Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Registration Statement on Form S-8 on November 21, 2007.
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(32)
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|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on January 3, 2008.
|
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(33)
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|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Post-Effective Amendment No. 2 to the Registrants Registration Statement on Form S-1 on
January 28, 2008.
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|
(34)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on March 24, 2008.
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*
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Filed or furnished herewith
|
|
**
|
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Portions of this exhibit have been omitted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment.
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***
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Denotes management contract or compensation plan or arrangement.
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****
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Previously filed.
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Item 17.
Undertakings.
(a) The undersigned registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made, a post-effective
amendment to this registration statement:
(i) To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
and
(ii) To reflect in the prospectus any facts or events arising after the effective date of
the registration statement (or the most recent post-effective amendment thereof) which,
individually or in the aggregate, represent a fundamental change in the information set forth in
the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of
securities offered (if the total dollar value of securities offered would not exceed that which
was registered) and any deviation from the low or high end of the estimated maximum offering
range may be reflected in the form of prospectus filed with the Commission pursuant to Rule
424(b) if, in the aggregate, the changes in volume and price represent no more than a 20 percent
change in the
maximum aggregate offering price set forth in the Calculation of Registration Fee table in
the effective registration statement; and
II-10
(iii) To include any material information with respect to the plan of distribution not
previously disclosed in the registration statement or any material change to such information in
the registration statement.
(2) That, for purposes of determining any liability under the Securities Act of 1933, each
such post-effective amendment shall be deemed to be a new registration statement relating to the
securities offered therein, and the offering as such securities at that time shall be deemed to
be the initial
bona fide
offering thereof.
(3) To remove from registration by means of a post-effective amendment any of the securities
being registered which remain unsold at the termination of the offering.
(b) Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be
permitted to directors, officers and controlling persons of the registrant pursuant to the
foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the
Securities and Exchange Commission such indemnification is against public policy as expressed in
the Act and is, therefore, unenforceable. In the event that a claim for indemnification against
such liabilities (other than the payment by the registrant of expenses incurred or paid by a
director, officer or controlling person of the registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or controlling person in connection with
the securities being registered, the registrant will, unless in the opinion of its counsel the
matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the
question whether such indemnification by it is against public policy as expressed in the Act and
will be governed by the final adjudication of such issue.
(c) The undersigned registrant hereby further undertakes that:
(i) For purposes of determining any liability under the Securities Act of 1933, the
information omitted from the form of prospectus filed as part of this registration statement in
reliance under Rule 430A and contained in a form of prospectus filed by the registrant pursuant
to Rule 424(b)(1) or (4), or 497(h) under the Securities Act of 1933 shall be deemed to be part
of this registration statement as of the time it was declared effective.
(ii) For the purpose of determining any liability under the Securities Act of 1933, each
post-effective amendment that contains a form of prospectus shall be deemed to be a new
registration statement relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial
bona fide
offering thereof.
II-11
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as amended, the registrant has
duly caused this Post-Effective Amendment No. 3 to Registration Statement on Form S-1 to be signed
on its behalf by the undersigned, thereunto duly authorized, in the City of Bethesda, State of
Maryland, on April 29, 2008.
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NORTHWEST BIOTHERAPEUTICS, INC.
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By:
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/s/
ANTHONY P. DEASEY
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Anthony P. Deasey
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Its: Senior Vice President and
Chief Financial Officer
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Pursuant to the requirements of the Securities Act of 1933, as amended, this Post-Effective
Amendment No. 3 to Registration Statement on Form S-1 has been signed by the following persons in
the capacities and on the dates indicated.
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Signature
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Title
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Date
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/s/ Alton L. Boynton
Alton L. Boynton, Ph.D.
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President, Chief Executive Officer and Director
(Principal Executive Officer)
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April 29, 2008
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/s/ Anthony P. Deasey
Anthony P. Deasey
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Senior Vice President of Finance and
Chief Financial Officer
(Principal Financial and Accounting Officer)
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April 29, 2008
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/s/ R. Steve Harris
R. Steve Harris
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Director
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April 29, 2008
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/s/ Linda F. Powers
Linda F. Powers
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Director
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April 29, 2008
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II-12
EXHIBIT INDEX
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Exhibit
|
|
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Number
|
|
Description
|
|
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|
3.1
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Seventh Amended and Restated Certificate of Incorporation (3.1)(22).
|
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3.2
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Third Amended and Restated Bylaws of the Company (3.1)(29).
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3.3
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Amendment to Seventh Amended and Restated Certificate of Incorporation (3.2)(29).
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3.4
|
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Amendment to Seventh Amended and Restated Certificate of Incorporation.(3.4)(33)
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4.1
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Form of common stock certificate.(4.1)(2)
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4.2
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Northwest Biotherapeutics, Inc. Stockholders Rights Agreement dated February 26,
2002 between the Company and Mellon Investors Services, LLC.(4.2)(3)
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|
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4.3
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Form of Rights Certificate.(4.1)(3)
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4.4
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Amendment to Northwest Biotherapeutics, Inc. Stockholders Rights Agreement dated
April 26, 2004.(4.2)(4)
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5.1****
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Opinion of Covington & Burling LLP as to the legality of the securities being
registered.
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10.1
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Amended and Restated Loan Agreement and 10% Promissory Note dated November 14,
2005 in the principal amount of $400,000 as amended and restated on April 14,
2007 between the Company and Toucan Partners, LLC.(10.1)(23)
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10.2
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Second Amended and Restated Loan Agreement and 10% Promissory Note originally
dated December 30, 2005, and amended and restated on April 17, 2006 and April
14, 2007 in the principal amount of $250,000 between the Company and Toucan
Partners, LLC.(10.2)(23)
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|
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10.3
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Second Amended and Restated Loan Agreement and 10% Promissory Note originally
dated March 9, 2006, and as amended and restated on April 17, 2006 and April 14,
2007 in the principal amount of $300,000 between the Company and Toucan
Partners, LLC.(10.3)(23)
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10.4
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Form of Loan Agreement and 10% Convertible, Promissory Note between the Company
and Toucan Partners, LLC.(10.4)(23)
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10.5
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Amended and Restated Investor Rights Agreement dated April 17, 2006.(10.4)(18)
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10.6
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Second Amended and Restated Investor Rights Agreement dated June 22, 2007
between the Company and Toucan Capital Fund II, LLP (10.3)(29).
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10.7
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Securities Purchase Agreement, dated March 30, 2006 by and among the Company and
the Investors identified therein.(10.1)(6)
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|
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10.8
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Form of Warrant.(10.2)(6)
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10.9
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Warrant to purchase securities of the Company dated April 26, 2004 issued to
Toucan Capital Fund II, L.P.(10.9)(7)
|
II-13
|
|
|
Exhibit
|
|
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Number
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|
Description
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|
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10.10
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Warrant to purchase securities of the Company dated June 11, 2004 issued to
Toucan Capital Fund II, L.P.(10.8)(7)
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10.11
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Warrant to purchase securities of the Company dated July 30, 2004 issued to
Toucan Capital Fund II, L.P.(10.7)(7)
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|
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10.12
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Warrant to purchase securities of the Company dated October 22, 2004 issued to
Toucan Capital Fund II, L.P.(10.3)(8)
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10.13
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Warrant to purchase securities of the Company dated November 10, 2004 issued to
Toucan Capital Fund II, L.P.(10.3)(9)
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|
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10.14
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Warrant to purchase securities of the Company dated December 27, 2004 issued to
Toucan Capital Fund II, L.P.(10.3)(10)
|
|
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10.15
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First Amendment to Warrants between Northwest Biotherapeutics, Inc. and Toucan
Capital Fund II, L.P. dated January 26, 2005.(10.5)(1)
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10.16
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Warrant to purchase Series A Cumulative Convertible Preferred Stock dated
January 26, 2005 issued to Toucan Capital Fund II, L.P.(10.2)(1)
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10.17
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Warrant to purchase securities of the Company dated April 12, 2005 issued to
Toucan Capital Fund II, L.P.(10.39)(11)
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10.18
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Warrant to purchase securities of the Company dated May 13, 2005 issued to
Toucan Capital Fund II, L.P.(10.3)(12)
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10.19
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Warrant to purchase securities of the Company dated June 16, 2005 issued to
Toucan Capital Fund II, L.P.(10.3)(13)
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10.20
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Warrant to purchase securities of the Company dated July 26, 2005 issued to
Toucan Capital Fund II, L.P.(10.3)(14)
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|
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10.21
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Warrant to purchase securities of the Company dated September 7, 2005 issued to
Toucan Capital Fund II, L.P.(10.3)(15)
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|
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10.22
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Amended Form of Warrant to purchase securities of the Company dated November 14,
2005 and April 17, 2006, as amended April 14, 2006, issued to Toucan Partners,
LLC.(10.21)(23)
|
|
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10.23
|
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Form of Warrant to purchase securities of the Company dated April 14, 2007
issued to Toucan Partners, LLC.(10.22)(23)
|
|
|
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10.24
|
|
Loan Agreement and 10% Convertible Promissory Note in the principal amount of
$100,000 between the Company and Toucan Partners, LLC, dated April 27, 2007
(10.1)(24).
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10.25
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Warrant to purchase securities of the Company issued to Toucan Partners, LLC.,
dated April 27, 2007 (10.2)(24).
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10.26
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Form of Toucan Partners Loan Agreement and 10% Convertible Note, dated as of
June 1, 2007 (10.1)(27).
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10.27
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Form of Toucan Partners Warrant, dated as of June 1, 2007 (10.2)(27).
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10.28
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Amended and Restated Warrant to Purchase Series A Preferred Stock issued to
Toucan
|
II-14
|
|
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Exhibit
|
|
|
Number
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|
Description
|
|
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Capital Fund II, L.P., dated as of June 1, 2007 (10.3)(27).
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10.29
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Warrant to Purchase Series A-1 Preferred Stock issued to Toucan Capital Fund II,
L.P., dated as of June 1, 2007 (10.4)(27).
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10.30
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Warrant to Purchase Series A-1 Preferred Stock issued to Toucan Capital Fund II,
L.P., dated as of June 1, 2007 (10.5)(27).
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|
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10.31
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Northwest Biotherapeutics, Inc. $225,000 Demand Note dated June 13, 2007
(10.1)(28).
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10.32
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Conversion Agreement dated June 15, 2007 and effective June 22, 2007 between the
Company and Toucan Capital Fund II, LLP (10.1)(29).
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10.33
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Termination Agreement dated June 22, 2007 between the Company and Toucan Capital
Fund II, LLP (10.2)(29).
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10.34
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Nomad Agreement dated June 15, 2007 and effective June 22, 2007 between the
Company and Collins Stewart Europe Limited (10.4)(29).
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|
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10.35***
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Employment Agreement dated June 18, 2007 between Dr. Alton L. Boynton and the
Company (10.6)(29).
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|
|
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10.36***
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|
Employment Agreement dated October 1, 2007 between Anthony P. Deasey and the
Company (10.1)(30).
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|
|
|
10.37***
|
|
Letter of Appointment for Linda F. Powers (10.8)(29).
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|
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10.38***
|
|
Letter of Appointment for R. Steve Harris (10.9)(29).
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|
|
|
10.39
|
|
Form of Warrant to purchase common stock of the Company, as amended.(10.27)(18)
|
|
|
|
10.40**
|
|
Northwest Biotherapeutics DCVax
® Brain Services Agreement with Cognate
BioServices, Inc. dated May 17, 2007.(10.1)(25)
|
|
|
|
10.41***
|
|
1998 Stock Option Plan.(10.15)(2)
|
|
|
|
10.42***
|
|
1999 Executive Stock Option Plan.(10.16)(2)
|
|
|
|
10.43***
|
|
2001 Stock Option Plan.(10.17)(2)
|
|
|
|
10.44***
|
|
2001 Nonemployee Director Stock Incentive Plan.(10.18)(2)
|
|
|
|
10.45***
|
|
Employee Stock Purchase Plan.(10.19)(2)
|
|
|
|
10.46***
|
|
2007 Stock Option Plan (10.5)(29).
|
|
|
|
10.47***
|
|
Form of Stock Option Agreement under the 2007 Stock Option Plan. (10.1)(31)
|
|
|
|
10.48
|
|
Lease Agreement.(10.34)(18)
|
|
|
|
10.49
|
|
Lease Extension between the Company and the International Union of Operating
Engineers Local 302, dated May 31, 2007 (10.1)(26).
|
|
|
|
10.50
|
|
Clinical Study Agreement between the Company and the Regents of the University
of California dated February 14, 2006.(10.35)(18)
|
|
|
|
10.51***
|
|
Employment Agreement dated
June 18, 2007 between James D. Johnston and Northwest
|
II-15
|
|
|
Exhibit
|
|
|
Number
|
|
Description
|
|
|
Biotherapetics, Inc. (10.7)(29)
|
|
|
|
10.52***
|
|
Form of Stock Option Agreement, dated December 31, 2007 by and between Dr. Alton
L. Boynton and the Company. (99.1)(32)
|
|
|
|
10.53***
|
|
Form of Stock Option Agreement, dated December 31, 2007 by and between Dr.
Marnix Bosch and the Company. (99.2)(32)
|
|
|
|
10.54
|
|
Sublease Agreement, dated as of March 21, 2008, between the Company and Toucan
Capital Corporation.(10.1)(34)
|
|
|
|
11.1
|
|
Computation of net loss per share included within the Northwest Biotherapeutics,
Inc. audited financial statements for the year ended December 31, 2007 included
in this Registration Statement on pages F-16 through F-43.
|
|
|
|
21****
|
|
Subsidiary of the registrant.
|
|
|
|
23.1*
|
|
Consent of Peterson Sullivan, PLLC, Independent Registered Accounting Firm.
|
|
|
|
23.2
|
|
Consent of Covington & Burling LLP, included in the opinion filed as Exhibit 5.1.
|
|
|
|
*
|
|
Filed or furnished herewith.
|
|
**
|
|
Portions of this exhibit have been omitted and filed separately with the
Securities and Exchange Commission pursuant to a request for confidential treatment.
|
|
***
|
|
Denotes management contract or compensation plan or arrangement.
|
|
****
|
|
Previously filed.
|
|
(1)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on February 1, 2005.
|
|
(2)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Amendment No. 3 to the Registration Statement on Form S-1 (File No. 333-67350) on
November 14, 2001.
|
|
(3)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Registration Statement on Form 8-A on July 8, 2002.
|
|
(4)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Annual Report on Form 10-K on May 14, 2004.
|
|
(5)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Quarterly Report on Form 10-Q on November 14, 2005.
|
|
(6)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on March 31, 2006.
|
|
(7)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on August 6, 2004.
|
|
(8)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on October 28, 2004.
|
|
(9)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on November 16, 2004.
|
II-16
|
|
|
(10)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on December 30, 2004.
|
|
(11)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Annual Report on Form 10-K on April 15, 2005.
|
|
(12)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on May 18, 2005.
|
|
(13)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on June 21, 2005.
|
|
(14)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on August 1, 2005.
|
|
(15)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on September 9, 2005.
|
|
(16)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Quarterly Report on Form 10-Q on November 14, 2003.
|
|
(17)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on August 5, 2005.
|
|
(18)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Annual Report on Form 10-K on April 18, 2006.
|
|
(19)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on April 26, 2006.
|
|
(20)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Form 10-K/A on June 30, 2006.
|
|
(21)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrant Registration Statement on Form S-1 (File No. 33-134320) on May 19, 2006.
|
|
(22)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Amendment No. 1 to the Registration Statement on Form S-1(File No. 333-134320) on
July 17, 2006.
|
|
(23)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Form 10-K on April 17, 2007.
|
|
(24)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on May 3, 2007.
|
|
(25)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on May 21, 2007.
|
|
(26)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on June 4, 2007.
|
|
(27)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on June 7, 2007.
|
II-17
|
|
|
(28)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on June 18, 2007.
|
|
(29)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on June 22, 2007.
|
|
(30)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on October 2, 2007.
|
|
(31)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Registration Statement on Form S-8 on November 21, 2007.
|
|
(32)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on January 3, 2008.
|
|
(33)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Post-Effective Amendment No. 2 to the Registrants Registration Statement on Form S-1 on
January 28, 2008.
|
|
(34)
|
|
Incorporated by reference to the exhibit shown in the preceding parentheses filed with the
Registrants Current Report on Form 8-K on March 24, 2008.
|
II-18
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