As filed with the Securities and Exchange
Commission on January 4, 2013
Registration Statement
No. 333-_____
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-3
REGISTRATION STATEMENT UNDER
THE SECURITIES ACT OF 1933
Northwest Biotherapeutics, Inc.
(Exact name of registrant as specified
in its charter)
Delaware
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94-3306718
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(State or other jurisdiction
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(I.R.S. Employer
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of incorporation or organization)
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Identification No.)
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4800
Montgomery Lane, Suite 800
Bethesda, MD 20814
(240) 497-9024
(Address, including
zip code, and telephone number, including area code, of registrant’s principal executive offices)
Linda F. Powers
Chief Executive Officer
4800 Montgomery Lane, Suite 800
Bethesda, MD 20814
(240) 497-9024
(Name, address, including
zip code, and telephone number, including area code, of agent for service)
Copies to:
Jeffrey J. Fessler, Esq.
Marcelle S. Balcombe, Esq.
Sichenzia Ross Friedman Ference LLP
61 Broadway, 32
nd
Floor
New York, New York 10006
Telephone: (212) 930-9700
Facsimile: (212) 930-9725
Approximate date of commencement of proposed sale to the public:
From time to time after the effective date of this Registration Statement.
If
the only securities being registered on this Form are being offered pursuant to dividend or interest reinvestment plans, please
check the following box.
¨
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.
x
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.
¨
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.
¨
If
this Form is a registration statement pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become
effective upon filing with the Commission pursuant to Rule 462(c) under the Securities Act, check the following box.
¨
If
this Form is a post-effective amendment filed pursuant to General Instruction I.D. filed to register additional securities or additional
classes of securities pursuant to Rule 413(b) under the Securities Act, check the following box.
¨
Indicate by check mark whether the Registrant is a large accelerated
filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See the definitions of “accelerated
filer”, “large accelerated filer” and “smaller reporting company” (as defined in Rule 12b-2 of the
Act) (Check one):
Large accelerated filer
¨
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Accelerated filer
¨
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Non-accelerated filer
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(Do not check if smaller reporting company)
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Smaller reporting company
x
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CALCULATION OF REGISTRATION FEE
Title of each class of
securities to be registered
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Amount
to
be
registered
(1)
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Proposed
maximum
aggregate
offering
price
per
unit
(2)
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Proposed maximum
aggregate
offering price
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|
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Amount
of
registration
fee
(3)
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|
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Common stock, $0.001 par value per share
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|
|
—
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|
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$
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—
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|
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$
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—
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|
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$
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—
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Preferred stock, $0.001 par value per share
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|
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—
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|
|
|
—
|
|
|
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—
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|
|
|
—
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Warrants
|
|
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—
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|
|
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—
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|
|
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—
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|
|
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—
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Debt Securities
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|
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—
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|
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—
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|
|
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—
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—
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Units
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—
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—
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—
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—
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Total
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—
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—
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$
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100,000,000
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$
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13,640
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(1)
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There are being registered hereunder such indeterminate number of shares of common stock and preferred stock, such indeterminate principal amount of debt securities, such indeterminate number of warrants to purchase common stock, preferred stock and debt securities, and such indeterminate number of units of securities of the Registrant as shall have an aggregate initial offering price not to exceed $100,000,000, less the aggregate dollar amount of all securities previously issued hereunder. If any debt securities are issued at an original issued discount, then the offering price of such debt securities shall be in such greater principal amount as shall result in an aggregate offering price not to exceed $100,000,000, less the aggregate dollar amount of all securities previously issued hereunder. Any securities registered hereunder may be sold separately or as units with the other securities registered hereunder. The proposed maximum offering price per unit will be determined, from time to time, by the Registrant in connection with the issuance by the Registrant of the securities registered hereunder. The securities registered hereunder also include such indeterminate number of shares of common stock and preferred stock and amount of debt securities as may be issued upon conversion of or exchange for preferred stock or debt securities that provide for conversion or exchange, upon exercise of warrants or pursuant to the antidilution provisions of any of such securities. In addition, pursuant to Rule 416 under the Securities Act of 1933, the shares being registered hereunder include such indeterminate number of shares of common stock and preferred stock as may be issuable with respect to the shares being registered hereunder as a result of stock splits, stock dividends or similar transactions. At no time will the maximum aggregate offering price of all securities issued in any given 12-month period exceed the amount allowed in General Instruction I.B.6 of Form S-3.
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(2)
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The proposed maximum offering price per unit will be determined from time to time by the Registrant in connection with, and at the time of, the issuance of the securities and is not specified as to each class of security pursuant to General Instruction II.D. of Form S-3, as amended.
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(3)
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Calculated pursuant to Rule 457(o) under the Securities Act of 1933 based on the proposed maximum aggregate offering price of all securities listed.
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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 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. We may not sell these securities or accept an offer to buy these securities until the registration
statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities,
and we are not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.
Subject to completion, dated January
4, 2013
Prospectus
$100,000,000 of
Common Stock,
Preferred Stock,
Warrants
Debt Securities,
and/or
Units
From time to time, we may offer up to $100,000,000
of any combination of the securities described in this prospectus, either individually or in units, in one or more offerings in
amounts, at prices and on the terms that we will determine at the time of offering. We may also offer common stock or preferred
stock upon conversion of debt securities, common stock upon conversion of preferred stock, or common stock, preferred stock or
debt securities upon the exercise of warrants.
Each time we sell securities, we will provide
specific terms of the securities offered in a supplement to this prospectus. The prospectus supplement may also add, update or
change information contained in this prospectus. We will specify in any accompanying prospectus supplement the terms of any offering.
You should read this prospectus and the applicable prospectus supplement, as well as any documents incorporated by reference in
this prospectus and any prospectus supplement, carefully before you invest in any securities.
This prospectus may not be used
by us to consummate a sale of securities unless accompanied by the applicable prospectus supplement.
We will sell these securities directly to
our stockholders or to other purchasers or through agents on our behalf or through underwriters or dealers as designated from time
to time. If any agents or underwriters are involved in the sale of any of these securities, the applicable prospectus supplement
will provide the names of the agents or underwriters and any applicable fees, commissions or discounts.
Our common stock and warrants trade on
The NASDAQ Capital Market under the trading symbols “NWBO” and “NWBOW,” respectively. On January 3,
2013, the last reported sale price of our common stock and warrants was $3.27 and $1.55, respectively. We recommend that you
obtain current market quotations for our common stock and warrants prior to making an investment decision.
You should carefully read this prospectus,
the prospectus supplement relating to any specific offering of securities and all information incorporated by reference herein
and therein.
Investing in our securities
involves a high degree of risk. These risks are discussed in this prospectus under “Risk Factors” beginning on
page 3 and in the documents incorporated by reference into this prospectus.
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 , 2013
TABLE OF CONTENTS
About This Prospectus
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1
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Prospectus Summary
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2
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Risk Factors
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3
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Special Note Regarding Forward-Looking Statements
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13
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Use of Proceeds
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13
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Ratio of Earnings to Fixed Charges
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13
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The Securities We May Offer
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13
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Description of Capital Stock
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15
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Description of Debt Securities
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18
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Description of Warrants
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19
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Description of Units
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21
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Plan of Distribution
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22
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Legal Matters
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24
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Experts
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24
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Where You Can Find More Information
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24
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Incorporation of Documents by Reference
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25
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ABOUT THIS PROSPECTUS
This prospectus
is part of a registration statement that we filed with the Securities and Exchange Commission, or SEC, utilizing a “shelf”
registration process. Under this shelf registration process, we may offer shares of our common stock and preferred stock, various
series of debt securities and/or warrants to purchase any of such securities, either individually or in units, in one or more offerings,
up to a total dollar amount of $100,000,000. This prospectus provides you with a general description of the securities we may offer.
Each time we offer a type or series of securities under this prospectus, we will provide a prospectus supplement that will contain
specific information about the terms of that offering.
This prospectus
does not contain all of the information included in the registration statement. For a more complete understanding of the offering
of the securities, you should refer to the registration statement, including its exhibits. Prospectus supplements may also add,
update or change information contained or incorporated by reference in this prospectus. However, no prospectus supplement will
fundamentally change the terms that are set forth in this prospectus or offer a security that is not registered and described in
this prospectus at the time of its effectiveness. This prospectus, together with the applicable prospectus supplements and the
documents incorporated by reference into this prospectus and the applicable prospectus supplement, includes all material information
relating to this offering. You should carefully read this prospectus, the applicable prospectus supplement, the information and
documents incorporated herein and therein by reference and the additional information under the heading “Where You Can Find
More Information” before making an investment decision.
You should rely only on the information
we have provided or incorporated by reference in this prospectus or any prospectus supplement. We have not authorized anyone to
provide you with information different from that contained or incorporated by reference in this prospectus. No dealer, salesperson
or other person is authorized to give any information or to represent anything not contained or incorporated by reference in this
prospectus. You must not rely on any unauthorized information or representation. This prospectus is an offer to sell only the securities
offered hereby, but only under circumstances and in jurisdictions where it is lawful to do so. You should assume that the information
in this prospectus or any prospectus supplement is accurate only as of the date on the front of the document and that any information
we have incorporated herein by reference is accurate only as of the date of the document incorporated by reference, regardless
of the time of delivery of this prospectus or any sale of a security.
To the extent
there are inconsistencies between any prospectus supplement, this prospectus and any documents incorporated by reference, the document
with the most recent date will control.
This prospectus
may not be used to consummate sales of our securities, unless it is accompanied by a prospectus supplement.
Unless the context
otherwise requires, “Northwest Biotherapeutics,” the “company,” “we,” “us,” “our”
and similar names refer to Northwest Biotherapeutics, Inc.
PROSPECTUS SUMMARY
This summary highlights information
contained elsewhere in this prospectus. Because it is a summary, it might not contain all of the information that is important
to you. Accordingly, you are urged to carefully review this prospectus in its entirety, including “Risk Factors” beginning
on page 3 and our financial statements and related notes thereto incorporated by reference herein, before making an investment
decision.
Business Overview
We are a development stage biotechnology
company focused on developing immunotherapy products to treat cancers more effectively than current treatments, without toxicities
of the kind associated with chemotherapies, and, through a proprietary batch manufacturing process, on a cost-effective affordable
basis initially in both the United States and Europe (the two largest medical markets in the world).
We have developed a platform technology,
DCVax, which uses activated dendritic cells to mobilize a patient's own immune system to attack their cancer. The DCVax technology
is expected to be applicable to most cancers, and is embodied in several complementary product lines. One of the product lines
(DCVax-L) is designed to cover all solid tumor cancers in which the tumors can be surgically removed. Another product line (DCVax-Direct)
is designed for all solid tumor cancers which are considered inoperable and cannot be surgically removed. The broad applicability
of DCVax to many cancers provides multiple opportunities for commercialization and partnering.
After more than a decade of pre-clinical
and clinical development, the DCVax technology has reached late stage development for two different cancers (brain and prostate),
with a Phase III clinical trial in glioblastoma multiforme, or GBM, brain cancer currently under way, and a Phase III clinical
trial in prostate cancer which was previously cleared to proceed by the U.S. Food and Drug Administration, or FDA, which we anticipate
will proceed when we secure a partner. We have also completed a small early stage trial in metastatic ovarian cancer, and we have
received clearance from the FDA for early stage trials in multiple other diverse cancers.
In the Phase I/II trials which formed the
foundation for reaching these late stage Phase III trials, the clinical results with DCVax were striking. DCVax treatment delayed
disease progression and extended survival by years, rather than weeks or months as is typical with cancer drugs. In addition, DCVax
was non-toxic: no serious adverse events related to the treatment were seen. These clinical results (both the efficacy and the
lack of toxicity) are consistent with a large and growing body of scientific literature and clinical experience, relating to the
underlying biology involved.
As of January
4, 2013, our Phase III clinical trial in GBM is being conducted at 41 sites across the United States. Due to the expansion
of the trial in the U.S., and the patient flow in the trial, we are amending our agreement with Cognate BioServices, our contract
manufacturer, to double the amount of manufacturing capacity for DCVax.
The Phase III GBM trial is also progressing
in Europe. On August 23, 2012, we announced that we received approval from the Medicines and Healthcare Products Regulatory Authority
in the United Kingdom to proceed with our Phase III clinical trial in GBM in the U.K., and 4 major medical centers in the U.K.
are preparing to proceed with the trial. On July 25, 2012, we announced that manufacturing certification has been received from
the German regulatory authorities, which is the first step towards implementation of the Phase III trial in Germany. As of January
4, 2013, 24 clinical centers are in varying stages of preparations as trial sites in Germany. We have accelerated and strengthened
our programs in Europe by partnering with large, prominent institutions, including the Fraunhofer Institute in Germany and Kings
College Hospital in the U.K.
Our DCVax immunotherapies are based on a
platform technology involving dendritic cells, the master cells of the immune system, and are designed to reinvigorate and educate
the immune system to attack cancers. The dendritic cells are able to mobilize all parts of the immune system, including T cells,
B cells and antibodies, natural killer cells and many others. Mobilizing the entire immune system provides a broader attack on
the cancer than mobilizing just a particular component, such as T cells alone, or a particular antibody alone. Likewise, our DCVax
technology is designed to attack the full set of biomarkers, or antigens on a patient’s cancer, rather than just a particular
selected target or several targets. Clinical experience indicates that when just one or a few biomarkers on a cancer are targeted
by a drug or other treatment, sooner or later the cancer usually develops a way around that drug, and the drug stops working. We
believe that mobilizing all agents of the immune system, and targeting all biomarkers on the patient’s cancer, contributes
to the effectiveness of DCVax.
We believe that the market potential of
this technology is particularly large because the DCVax products are expected to be applicable to most cancers. We believe that
the market potential is also enhanced by our two-continent strategy. By conducting our Phase III clinical trial in GBM on an international
basis, with trial sites in both the United States and Europe, we believe we are positioned to potentially apply for product approval
in both markets.
Recent Developments
In August 2012, our Board and a majority
of our stockholders approved an amendment to our Amended and Restated 2007 Stock Option Plan providing that, on an ongoing basis,
effective January 1 each year, the aggregate number of shares of common stock that are available for issuance under the plan shall
automatically be increased by such number of shares as is sufficient to cause the option pool to equal twenty percent (20%) of
our issued and outstanding common stock at such time.
On September 25, 2012, we effected a 1-for-16
reverse stock split of our issued and outstanding common stock. In addition, we filed an amendment to our certificate of incorporation
increasing our authorized shares of preferred stock from 20,000,000 to 40,000,000.
In December, 2012, we retired $34.6 million
in aggregate amount of convertible notes, notes and payables by entering into Conversion Agreements with our non-affiliated and
affiliated note holders and creditors, including certain of our directors and executive officers. This aggregate debt amount was
converted into 9,615,177 common shares and warrants exercisable for 4,807,584 shares of common stock. The warrants have an exercise period
of five years from the date of issuance and an exercise price of $6.40 per share.
Corporate Information
We were
formed in 1996 and incorporated in Delaware in July 1998. Our principal executive offices are located in Bethesda, Maryland, and
our telephone number is (240) 497-9024. Our website address is
www.nwbio.com
. The information on our website is not part
of this prospectus. We have included our website address as a factual reference and do not intend it to be an active link to our
website.
RISK FACTORS
Investing in
our securities involves risk. The prospectus supplement applicable to each offering of our securities will contain a discussion
of the risks applicable to an investment in our company. Prior to making a decision about investing in our securities, you should
carefully consider the specific factors discussed below and under the heading “Risk Factors” in the applicable prospectus
supplement, together with all of the other information contained or incorporated by reference in the prospectus supplement or appearing
or incorporated by reference in this prospectus. You should also consider the risks, uncertainties and assumptions discussed under
the heading “Risk Factors” included in our most recent annual report on Form 10-K, as revised or supplemented
by our most recent quarterly report on Form 10-Q, each of which are on file with the SEC and are incorporated herein by reference,
and which may be amended, supplemented or superseded from time to time by other reports we file with the SEC in the future.
Risks Related to our Business
We will need to raise substantial
funds, on an ongoing basis, for general corporate purposes and operations, including our clinical trials. Such funding may not
be available or may not be available on attractive terms.
As of September 30, 2012, we had approximately
$0.1 million of cash on hand. In December, 2012, we received gross proceeds of approximately $14 million in a public offering of
our shares and warrants. Also, in December 2012, we retired $34.6 million in aggregate amount of convertible notes, notes and payables
by entering into Conversion Agreements with our non-affiliated and affiliated note holders and creditors, including certain of
our directors and executive officers. This aggregate debt amount was converted into 9,615,777 common shares and warrants exercisable
for 4,807,584 shares of common stock.
We will need
substantial additional funding, on an ongoing basis, in order to continue execution of our clinical trials, to move our product
candidates towards commercialization, to continue prosecution and maintenance of our large patent portfolio, to continue development
and optimization of our manufacturing and distribution arrangements, and for other corporate purposes. Any financing, if available,
may include restrictive covenants and provisions that could limit our ability to take certain actions, preference provisions for
the investors, and/or discounts, warrants or other incentives. Any financing will involve issuance of equity and/or debt, and such
issuances will be dilutive to existing shareholders. 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 some or all of our 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
$251.8 million and $288.6 million as of December 31, 2011 and September 30, 2012, respectively, of which $117.2 million was cash
expenditures and $134.6 million was non-cash accounting measures as of December 31, 2011 and $131.7 million was cash expenditures
and $156.9 million was non-cash accounting measures as of September 30, 2012. We expect that these losses will continue, and we
anticipate negative cash flows from operations for the foreseeable future. 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, 2011 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 if we do
not continue as a going concern. 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 shareholders,
in the event of liquidation.
As a development stage company
with a novel technology and 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 still in the process of developing our product candidates through clinical trials. Our technology
is novel and involves mobilizing the immune system to fight a patient’s cancer. Immune therapies have been pursued by many
parties for decades, and have experienced many failures. In addition, our technology involves personalized treatment products,
a new approach to medical products that involves new product economics and business strategies, which have not yet been shown to
be commercially feasible or successful. We have not yet gone through scale-up of our operations to commercial scale. This limited
operating history, along with the novelty of our technology, product economics, and business strategy, and the limited scale of
our operations to date, makes it difficult to assess our prospects for generating revenues commercially in the future.
We will need to expand our
management and technical personnel as our operations progress, and we may not be able to recruit such additional personnel and/or
retain existing personnel.
As of December
31, 2012, we employ eight (8) full-time employees. The rest of our personnel are retained on a consulting or contractor basis.
Biotech companies would typically have a larger number of employees by the time they reach late stage clinical trials. Such trials
require extensive management activities and skill sets, including scientific, medical, regulatory (for FDA and foreign regulatory
counterparts), manufacturing, distribution and logistics, site management, business, financial, legal, public relations outreach
to both the patient community and physician community, intellectual property, administrative, regulatory (SEC), investor relations
and other.
In order
to fully perform all these diverse functions, with late stage trials under way at many sites across the U.S. and soon in Europe,
we will need to expand our management and technical personnel. However, the pool of such personnel with expertise and experience
with living cell products, such as our DCVax immune cell product, is very limited. In addition, we are a small company with limited
resources, our business prospects are uncertain and our stock price is volatile. For some or all of such reasons, we may not be
able to recruit all the management and technical personnel we need, and/or we may not be able to retain all of our existing personnel.
In such event, we may have to continue our operations with a smaller than usual team of personnel, and our business and financial
results may suffer.
We rely at present on third-party
contract manufacturers. As a result, we may be at risk for capacity limitations and/or supply disruptions.
We currently
rely upon Cognate BioServices, Inc., or Cognate, to produce all of our DCVax product in the U.S., and to supervise the production
of our DCVax product candidates outside the U.S. The majority owner of Cognate is Toucan Capital, one of our major stockholders,
and its affiliates. We have an agreement in place with Cognate pursuant to which Cognate has agreed to provide manufacturing and
other services for the next five years, in connection with our Phase III clinical trial of DCVax -L in brain cancer, and other
programs. The agreement requires us to make certain minimum monthly payments to Cognate in order to have dedicated manufacturing
capacity available for our products, irrespective of whether we actually order any DCVax products. The agreement also specifies
the amounts we must pay for Cognate's actual manufacturing of DCVax for patients.
We have entered
into an agreement with King’s College London to manufacture DCVax for our clinical trial and our compassionate use cases.
Cognate will manage and supervise the processing in London. In addition, our partner, Fraunhofer, has received approval and certification
from the regional and national regulatory agencies in Germany for the manufacture of DCVax for GBM. We anticipate that the manufacturing
facilities in the U.K. and Germany will be able to supply DCVax products for anywhere in Europe (and to the U.S., if needed), however
this may not turn out to be feasible, for regulatory, operational and/or logistical reasons.
Problems with
the manufacturing facilities or processes of Cognate or our partners in the U.K. and/or Germany could result in a failure to produce,
or a delay in production, of adequate supplies of our DCVax product candidates. A number of factors could cause interruptions or
delays, including the inability of a supplier to provide raw materials, equipment malfunctions or failures, damage to a facility
due to natural disasters or otherwise, changes in FDA regulatory requirements or standards that require modifications to our manufacturing
processes, action by the FDA or European regulators, or by us that results in the halting or slowdown of production of components
or finished products due to regulatory issues, our manufacturers going out of business or failing to produce product as contractually
required, and/or other similar factors. Because manufacturing processes for our DCVax product candidates are highly complex, require
specialized facilities and personnel that are not widely available in the industry, involve equipment and training with long lead
times, and are subject to lengthy regulatory approval processes, alternative qualified production capacity may not be available
on a timely basis or at all. Difficulties, delays or interruptions in the manufacturing and supply of our DCVax product candidates
could require us to stop enrolling additional new patients into our trial, and/or require us to stop the trial or other program,
increase our costs, damage our reputation and, if our product candidates are approved for sale, cause us to lose revenue or market
share if our manufacturers are unable to timely meet market demands.
The manufacturing of our
product candidates will have to be greatly scaled up for commercialization, and neither we nor other parties in the industry have
experience with such scale-up.
As is the case
with any clinical trial, our Phase III clinical trial of DCVax-L for GBM involves a number of patients that is a small fraction
of the number of potential patients for whom DCVax-L may be applicable in the commercial market. The same will be true of our other
clinical programs with our other DCVax product candidates. If our DCVax-L, and/or other DCVax product candidates, are approved
for commercial sale, it will be necessary to greatly scale up the volume of manufacturing, far above its level for the trials.
Neither we nor our contract manufacturers have experience with such scale-up. In addition, there are virtually no consultants or
advisors in the industry who have such experience and can provide guidance or assistance, because active immune therapies such
as DCVax are a fundamentally new category of product in two major ways: these active immune therapy products consist of living
cells, not chemical or biologic compounds, and the products are personalized. To our knowledge, no such products have successfully
completed the necessary scale-up for commercialization without material difficulties. For example, Dendreon has encountered substantial
difficulties trying to scale up the manufacturing of its Provenge product for commercialization.
The necessary specialized
facilities, equipment and personnel may not be available or obtainable for the scale-up of manufacturing of our product candidates.
The manufacture
of living cells requires specialized facilities, equipment and personnel which are entirely different than what is required for
manufacturing of chemical or biologic compounds. Scaling up the manufacturing of living cell products to volume levels required
for commercialization will require enormous amounts of these specialized facilities, equipment and personnel — especially
where, as in the case of our DCVax product candidates, the product is personalized and must be made for each patient individually.
Since living cell products are so new, and have barely begun to reach commercialization, the supply of the specialized facilities,
equipment and personnel needed for them has not yet developed. It may not be possible for us or our manufacturers to obtain all
of the specialized facilities, equipment and personnel needed for commercialization of our DCVax product candidates. This could
delay or halt our commercialization.
Our technology is novel,
involves complex immune system elements, and may not prove to be effective.
Data already
obtained, or in the future obtained, from pre-clinical studies and clinical trials do not necessarily predict the results that
will be obtained from later pre-clinical studies and clinical trials. Over the course of several decades, there have been many
different immune therapy product designs — and many product failures and company failures. To our knowledge, to
date, only one active immune therapy, Provenge, has been approved by the FDA. The human immune system is complex, with many diverse
elements, and the state of scientific understanding of the immune system is still limited. Some immune therapies previously developed
by other parties showed surprising and unexpected toxicity in clinical trials. Other immune therapies developed by other parties
delivered promising results in early clinical trials, but failed in later stage clinical trials. To date, we have only completed
early stage trials in limited numbers of patients. Although the results of those trials were quite positive, those results may
not be achieved in our later stage clinical trials, such as the 300-patient Phase III trial we are now conducting for GBM, and
our product candidates may not ultimately be found to be effective.
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. Costs and timing
of clinical trials may vary significantly over the life of a project owing to any or all of the following non-exclusive reasons:
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the duration of the clinical trial;
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the number of sites included in the trials;
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the countries in which the trial is conducted;
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the length of time required and ability to enroll eligible patients;
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the number of patients that participate in the trials;
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the number of doses that patients receive;
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the drop-out or discontinuation rates of patients;
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per patient trial costs;
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third party contractors failing to comply with regulatory requirements or meet their contractual obligations to us in a timely manner;
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our final product candidates having different properties in humans than in lab testing;
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the need to suspect or terminate our clinical trials;
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insufficient or inadequate supply of quality of necessary materials to conduct our trials;
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potential additional safety monitoring, or other conditions required by FDA or comparable foreign regulatory authorities regarding the scope or design of our clinical trials, or other studies requested by regulatory agencies;
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problems engaging IRBs to oversee trials or in obtaining and maintaining IRB approval of studies;
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the duration of patient follow-up;
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the efficacy and safety profile of a product candidate;
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the costs and timing of obtaining regualtory approvals; and
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the costs involved in enforcing or defending patent claims or other intellectual property rights.
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Late stage clinical
trials, such as our Phase III clinical trial for GBM patients, are especially expensive, typically requiring tens of millions of
dollars, and take years to reach their outcomes. Such outcomes often fail to reproduce the results of earlier trials. It is often
necessary to conduct multiple late stage trials (including multiple Phase III trials) in order to obtain sufficient results to
support product approval, which further increases the expense. Sometimes trials are further complicated by changes in requirements
while the trials are under way (for example, when the standard of care changes for the disease that is being studied in the trial).
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 delay or stop the commercialization of our DCVax product candidates.
We may be required to suspend
or discontinue clinical trials due to unexpected side effects or other safety risks that could preclude approval of our product
candidates.
Our clinical
trials may be suspended at any time for a number of reasons. For example, we may voluntarily suspend or terminate our clinical
trials if at any time we believe that they present an unacceptable risk to the clinical trial patients. In addition, the FDA or
other regulatory agencies may order the temporary or permanent discontinuation of our clinical trials at any time if they believe
that the clinical trials are not being conducted in accordance with applicable regulatory requirements or that they present an
unacceptable safety risk to the clinical trial patients.
Administering
any product candidate to humans may produce undesirable side effects. These side effects could interrupt, delay or halt clinical
trials of our product candidates and could result in the FDA or other regulatory authorities denying further development or approval
of our product candidates for any or all targeted indications. Ultimately, some or all of our product candidates may prove to be
unsafe for human use. Moreover, we could be subject to significant liability if any volunteer or patient suffers, or appears to
suffer, adverse health effects as a result of participating in our clinical trials.
We have limited experience
in conducting and managing clinical trials.
We rely on third
parties to assist us, on a contract services basis, in managing and monitoring all of our clinical trials. We do not have experience
conducting late stage clinical trials ourselves without third party service firms, other than our current Phase III trial, nor
do we have experience in supervising such third parties in managing late stage, multi-hundred patient clinical trials, other than
our current Phase III trial. Our lack of experience and/or our reliance on these third party service firms may result in delays
or failure to complete these trials successfully and on time. If the third parties fail to perform, we may not be able to find
sufficient alternative suppliers of those services in a reasonable time period, or on commercially reasonable terms, if at all.
If we were unable to obtain alternative suppliers of such services, we might be forced to delay, suspend or stop our 300-patient
Phase III clinical trial of DCVax-L for GBM.
Multiple late stage clinical
trials of DCVax-L for GBM, our lead product, may be required before we can obtain regulatory approval.
Typically, companies
conduct multiple late stage clinical trials of their product candidates before seeking product approval. Our current Phase III
300-patient clinical trial of DCVax-L for GBM is our first late stage trial. We may be required to conduct additional late stage
trials with DCVax-L for GBM before we can obtain product approval. This would substantially delay our commercialization. There
is also some possibility that changes requested by the FDA could complicate the application process for product approval. In addition,
a number of products are under development for brain cancer and at least one has recently been approved in the U.S.. It is possible
that the standard of care for brain cancer could change while our Phase III trial is still under way. This could necessitate further
clinical trials with our DCVax-L product candidate for brain cancer.
Changes in manufacturing
methods for DCVax-L could require us to conduct equivalency studies and/or additional clinical trials.
With biologics
products, “the process is the product”: i.e., the manufacturing process is considered to be as integral to the product
as is the composition of the product itself. If any changes are made in the manufacturing process, and such changes are considered
material by the regulatory authorities, the company sponsor may be required to conduct equivalency studies to show that the product
is equivalent under the changed manufacturing processes as under the original manufacturing processes, and/or the company sponsor
may be required to conduct additional clinical trials. Our manufacturing processes have undergone some changes during the early
clinical trials. Accordingly, we may be required to conduct equivalency studies, and/or additional clinical trials, before we can
obtain product approval, unless the regulatory authorities are satisfied that the changes in processes do not affect the quality,
efficacy or safety of the product.
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 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, or EMA, will regulate in Europe. 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, and there can be no assurance that the regulatory authorities will find our data sufficient to support product
approval of DCVax-L.
The time required
to obtain regulatory approval varies between countries. In the U.S., for products without “Fast Track” status, it can
take up to eighteen (18) months after submission of an application for product approval to receive the FDA's decision. Even with
Fast Track status, FDA review and decision can take up to twelve (12) months. At present, we do not have Fast Track status
for our lead product, DCVax-L for GBM. We plan to apply for Fast Track status, but there can be no assurance that FDA will grant
us such status for DCVax-L.
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 as well as case load at the regulatory agency at the
time.
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 current good manufacturing practices, or 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.
Regulatory approval of our
product candidates 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, including
the review of adverse experiences and clinical results that are reported after our products are made available to patients, 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 such obligations are not fulfilled. If post-approval studies are required, such studies may involve significant
time and expense.
The manufacturer
and manufacturing facilities we use to make any of our products will also be subject to periodic review and inspection by the FDA
or EMA, as applicable. The discovery of any new or previously unknown problems with the product, manufacturer or facility may result
in restrictions on the product or manufacturer or facility, including withdrawal of the product from the market. We will continue
to be subject to the FDA or EMA requirements, as applicable, governing the labeling, packaging, storage, advertising, promotion,
recordkeeping, and submission of safety and other post-market information for all of our product candidates, even those that the
FDA or EMA, as applicable, had approved. If we fail to comply with applicable continuing regulatory requirements, we may be subject
to fines, suspension or withdrawal of regulatory approval, product recalls and seizures, operating restrictions and other adverse
consequences.
Our product candidates will
require a different distribution model than conventional therapeutic products, and this may impede commercialization of our product
candidates.
Our DCVax product
candidates consist of living human immune cells. Such products are entirely different from chemical or biologic drugs, and require
different handling, distribution and delivery than chemical or biologic drugs. One crucial difference is that our DCVax products
must remain frozen throughout the distribution and delivery process, until the time of administration to the patient, and cannot
be handled at room temperature. In addition, our DCVax product candidates are personalized and they involve ongoing treatment cycles
over several years for each patient. Each product shipment for each patient must be tracked and managed individually. For all of
these reasons, among others, we will not be able to simply use the distribution networks and processes that already exist for conventional
drugs. It may take time for shipping companies, hospitals, pharmacies and physicians to adapt to the requirements for handling,
distribution and delivery of these products, which may adversely affect our commercialization.
Our product candidates will
require different marketing and sales methods and personnel than conventional therapeutic products. Also, we lack sales and marketing
experience. These factors may result in significant difficulties in commercializing our 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 marketing
or sales force and have no experience in marketing or sales of products like our lead product, DCVax-L for GBM. To fully commercialize
our product candidates, we will need to recruit and train marketing staff and a sales force with technical expertise and ability
to manage the distribution of our DCVax-L for GBM. As an alternative, we could seek assistance from a corporate partner or a third
party services firm with a large distribution system and a large direct sales force. However, since our DCVax living cell, immune
therapy products are a fundamentally new and different type of product than are on the market today, we would still have to train
such partner’s or such services firms’ personnel about our products, and would have to make changes in their distribution
processes and systems to handle our products. We may be unable to recruit and train effective sales and marketing forces or our
own, or of a partner or a services firm, and/or doing so may be more costly and difficult than anticipated. Such factors may result
in significant difficulties in commercializing our product candidates, and we may be unable to generate significant revenues.
We may not obtain or maintain
the benefits associated with orphan drug status, including market exclusivity.
Although our
lead product, DCVax-L for GBM, has been granted orphan drug status in both the United States and the European Union, or EU, we
may not receive the benefits associated with orphan drug designation (including the benefit providing for market exclusivity for
a number of years). This may result from a failure to maintain orphan drug status, or result from a competing product reaching
the market that has an orphan designation for the same disease indication. Under U.S. and EU rules for orphan drugs, if such a
competing product reaches the market before ours does, the competing product could potentially obtain a scope of market exclusivity
that limits or precludes our product from being sold in the U.S. for seven years or from being sold in the EU for ten years. Also,
in the EU, even after orphan status has been granted, that status is re-examined shortly prior to the product receiving any regulatory
approval. The EMA must be satisfied that there is evidence that the product offers a significant benefit relative to existing therapies,
in order for the therapeutic product to maintain its orphan drug status. Accordingly, our product candidates will have to re-qualify
for orphan drug status prior to any potential product approval in the EU.
The availability and amount
of potential reimbursement for our product candidates by government and private payers is uncertain and may be delayed and/or inadequate.
The availability
and extent of reimbursement by governmental and/or private payers is essential for most patients to be able to afford expensive
treatments, such as cancer treatments. In the United States, the principal decisions about reimbursement for new medicines are
typically made by the Centers for Medicare & Medicaid Services, or CMS, an agency within the U.S. Department of Health and
Human Services, as CMS decides whether and to what extent a new medicine will be covered and reimbursed under Medicare. Private
payers tend to follow CMS to a substantial degree. It is difficult to predict what CMS will decide with respect to reimbursement
for fundamentally novel products such as ours, as there is no body of established practices and precedents for these new products.
To date, we are aware of only one active immune therapy that has reached the stage of a reimbursement decision (Provenge). Although
CMS approved coverage and reimbursement for Provenge, and private payers followed suit, there remain substantial questions and
concerns about reimbursement for Provenge, and such questions and concerns appear to be impeding sales.
Reimbursement
agencies in Europe can be even more conservative than CMS in the U.S.. A number of cancer drugs which have been approved for reimbursement
in the U.S. have not been approved for reimbursement in certain European countries, and/or the level of reimbursement approved
in Europe is lower than in the U.S.
Various factors
could increase the difficulties for our DCVax products to obtain reimbursement. Costs and/or difficulties associated with the reimbursement
of Provenge could create an adverse environment for reimbursement of other immune therapies, such as our DCVax products. Approval
of other competing products (drugs and/or devices) for the same disease indications could make the need for our products and the
cost-benefit balance seem less compelling. The cost structure of our product is not a typical cost structure for medical products,
as the majority of our costs are incurred up front, when the manufacturing of the personalized product is done. Our atypical cost
structure may not be accommodated in any reimbursement for our products. If we are unable to obtain adequate levels of reimbursement,
our ability to successfully market and sell our product candidates will be adversely affected.
The manner and
level at which reimbursement is provided for services related to our product candidates (e.g., for administration of our product
to patients) is also important. If the reimbursement for such services is inadequate, that may lead to physician resistance and
adversely affect our ability to market or sell our products.
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, or 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.
In markets
outside the U.S., where we plan to operate in the future, the prices of medical products are subject to direct price controls and/or
to reimbursement with varying price control mechanisms, as part of national health systems. In general, the prices of medicines
under such systems are substantially lower than in the U.S. Some jurisdictions operate positive and/or negative list systems under
which products may only be marketed once a reimbursement price has been agreed. Other countries 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.
Accordingly, in markets outside the U.S., the reimbursement for our products may be reduced compared with the U.S. and may be insufficient
to generate commercially reasonable revenues and profits.
Competition in the biotechnology
and biopharmaceutical industry is intense and most of our competitors have substantially greater resources than we do.
The biotechnology
and biopharmaceutical industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis
on proprietary products. Several companies, such as Dendreon, Celldex Therapeutics, Inc., Ark Therapeutics plc, Oxford Biomedica
plc, Argos Therapeutics, Inc., Agenus, Inc., Prima Biomed, Ltd., Avax Technologies, Inc., Immunocellular Therapeutics, Ltd., Bavarian
Nordic, Bellicum Pharmaceuticals, and others are actively involved in the research and development of immune therapies or cell-based
therapies for cancer. In addition, other novel technologies for cancer are under development, such as the electro-therapy device
of NovoCure. Of these companies, only one has obtained approval of such an immune therapy: Dendreon (for its Provenge treatment
of prostate cancer). 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, and a large number of additional ones are under development. 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, as well as some medical device companies (e.g., NovoCure and MagForce Nano Technologies
AG).
We face extensive
competition from companies developing new treatments for brain cancer. These include a variety of immune therapies, as mentioned
above, as well as a variety of small molecule drugs and biologics drugs . There are also a number of existing drugs used for the
treatment of brain cancer that may compete with our product, including, Avastin® (Roche Holding AG), Gliadel® (Eisai Co.
Ltd.), and Temodar® (Merck & Co., Inc.), as well as Novocure’s electrotherapy device.
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 and sales than we do. Smaller or early-stage
companies may also prove to be significant competitors, particularly if they enter into 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, and in obtaining sites for our clinical trials and enrolling patients.
Our competitors
may develop more effective or affordable products, or achieve earlier patent protection or earlier product marketing and sales.
Any products developed by us may be rendered obsolete and non-competitive.
Competing generic medicinal
products may be approved.
In the EU, there
exists a process for approval of generic biological medicinal products once patent protection and other forms of data and market
exclusivity have expired. Arrangements for approval of generic biologics products exist and are under consideration in the U.S.,
as well. Other jurisdictions are considering adopting legislation that would allow the approval of generic biological medicinal
products. If generic medicinal products are approved, competition from such products may substantially reduce sales of our products.
We may be exposed to potential
product liability claims, and our existing insurance may not cover these claims in whole or in part. In addition, insurance against
such claims may not be available to us on reasonable terms 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. We carry insurance coverage but this insurance may not cover any claims made. In the future, insurance coverage may not
be available to us on commercially reasonable terms (including acceptable cost), if at all. Insurance that we obtain may not be
adequate to cover claims against us. Regardless of whether they have any merit or not, and regardless of their eventual outcome,
product liability claims may result in substantially decreased demand for our product candidates, injury to our reputation, withdrawal
of clinical trial participants or physicians, and/or 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 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 we could 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.
Our intellectual property
rights may be overturned, narrowed or blocked, and may not provide sufficient commercial protection for our product candidates,
or third parties may infringe upon our intellectual property.
Patent laws
afford only limited protection and may not protect our rights to the extent necessary to sustain any competitive advantage we may
have. In addition, 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 those countries. Moreover patents and
patent applications relating to living cell products are relatively new, involve complex factual and legal issues, and are largely
untested in litigation — and as a result, are uncertain. Third parties may challenge our existing patents, and
such challenges could result in overturning or narrowing some of our patents. Even if our patents are not challenged, third parties
could assert that their patents block some or all of our patents
As of December
31, 2012, we have over 100 issued patents (7 in the U.S.) and more than 90 pending patent applications related to our product candidates,
and related processes such as manufacturing processes.
The issued patents
expire at various dates from 2015 to 2026. Our issued patents may be challenged, and such challenges may result in reductions in
scope or invalidations. Our pending patent applications may not result in issued patents. Moreover, our patents and patent applications
may not be sufficiently broad to prevent others from using substantially similar 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 (including execution of confidentiality agreements) 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. In addition, others may independently develop substantially equivalent
proprietary information or techniques or otherwise gain access to our trade secrets.
We may be exposed to claims
or lawsuits — with or without merit — on various subjects, including that our products infringe
patents or other proprietary rights of other parties.
There is a substantial
amount of litigation involving patent and other intellectual property rights in the biotechnology and biopharmaceutical industries
generally. The patent landscape is especially uncertain in regard to cell therapy products, as it involves complex legal and factual
questions for which important legal principles remain unresolved. Infringement and other intellectual property claims — with
or without merit — can be expensive and time-consuming to litigate and can divert management’s attention.
We have already been exposed to one frivolous patent lawsuit by a large company, which we vigorously defended and forced the large
company to withdraw all of the claims made. We have also been exposed to frivolous claims (without a lawsuit) by a competitor asserting
or implying inaccurately that a recent patent issued to them somehow covers our products (which it does not). In the future, we
may again be exposed to claims by third parties — with or without merit — that our products infringe
their intellectual property rights. Such claims or lawsuits may involve substantial costs and diversion of management attention
to defend.
In addition,
because patents can take many years to issue, and patent applications are not published until up to eighteen months after they
are filed, there may be currently pending applications, unknown to us, which may later result in issued patents that our products
may inadvertently infringe. There could also be existing patents of which we are not aware that one or more of our products may
inadvertently infringe.
DCVax is our only technology
in clinical development.
Unlike many
pharmaceutical companies that have a number of products in development and which utilize many different technologies, we are dependent
on the success of our DCVax platform technology. While the DCVax technology has a wide scope of potential use, and is embodied
in several different product lines for different clinical situations, if the core DCVax technology is not effective or is not commercially
viable, our business could fail. We do not currently have other technologies that could provide alternative support for us.
Collaborations play an important
role in our business, and could be vulnerable to competition or termination.
We work with
scientists and medical professionals at academic and other institutions, including UCLA, among others, some of whom have conducted
research for us or have assisted in developing our research and development strategy. These scientists and medical professionals
are collaborators, not our employees. They may have commitments to, or contracts with, other businesses or institutions that limit
the amount of time they have available to work with us. We have little control over these individuals. We can only expect that
they devote time to us and our programs as required by any license, consulting or sponsored research agreements we may have with
them. 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.
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.
Our business could be adversely
affected by new legislation and/or product related issues.
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 product’s sale or manufacture, including
the possible withdrawal of the product from the market, or may otherwise have an adverse effect on our business.
Our business could be adversely
affected by animal rights activists.
Our business
activities have involved animal testing, as such testing is required before new medical products can be tested in clinical trials
in patients. Animal testing has 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 that 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 also adversely affect our business.
Risks Related to our Common
Stock
The market price of our common stock may be volatile and
adversely affected by several factors.
The share prices
of publicly traded biotechnology and emerging pharmaceutical companies, particularly companies without consistent product revenues
and earnings, can be highly volatile and are likely to remain highly volatile in the future. The price which investors may realize
in sales of their shares of our common stock may be materially different than the price at which our common stock is quoted, and
will be influenced by a large number of factors, some specific to us and our operations, and some unrelated to our operations.
Such factors may cause the price of our stock to fluctuate frequently and substantially. Such factors may include large purchases
or sales of our common stock, positive or negative events relating to other companies developing immune therapies for cancer, positive
or negative events relating to healthcare and the overall pharmaceutical and biotech sector, currency fluctuations, legislative
or regulatory changes, and/or general economic conditions. In the past, shareholder class action litigation has been brought against
other companies that experienced volatility in the market price of their shares. Whether or not meritorious, litigation brought
against a company following fluctuations in the trading price of its common stock can result in substantial costs, divert management’s
attention and resources, and harm the company’s financial condition and results of operations.
Toucan Capital and its affiliates
are the principal holders of our shares of common stock, and this concentration of ownership may have a negative effect on the
market price of our common stock.
As of December
31, 2012, Toucan Capital and its affiliates (including Cognate BioServices, Toucan Partners and Linda Powers, who also serves as
our Chief Executive Officer and Chairperson of the Board of Directors), collectively, owned an aggregate of 10,958,287
shares of our common stock, representing approximately 42 percent of our issued and outstanding common stock. This concentration
of ownership may adversely affect the trading price of our common stock because investors may perceive disadvantages in owning
stock of companies with controlling stockholders. Toucan Capital and its affiliates have the ability to exert substantial influence
over all matters requiring approval by our stockholders, including the election and removal of directors and any proposed merger,
consolidation or sale of all or substantially all of our assets. This influence 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.
The requirements of the Sarbanes-Oxley
Act of 2002 and other U.S. securities laws impose substantial costs, and may drain our resources and distract our management.
We are subject
to certain of the requirements of the Sarbanes-Oxley Act of 2002 in the U.S., as well as the reporting requirements under the Exchange
Act. The Exchange Act requires, among other things, 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, with respect to our business and financial condition. The
Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures and internal controls
over financial reporting. Our existing controls have some weaknesses, as described below. Meeting the requirements of the Exchange
Act and the Sarbanes-Oxley Act may strain our resources and may divert management's attention from other business concerns, both
of which may have a material adverse effect on our business.
Our management and our independent
auditor have identified internal control deficiencies, which our management and our independent auditor believe constitute material
weaknesses.
In connection
with the preparation of our financial statements for the year ended December 31, 2011, and prior years, our management and our
independent auditor identified certain internal control deficiencies that, in the aggregate, represent material weaknesses, including:
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lack of a sufficient number of independent directors on our audit committee;
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lack of a financial expert on our audit committee;
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insufficient segregation of duties in our finance and accounting function due to limited personnel;
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lack of controls in place to ensure that all material developments impacting the financial statements are reflected;
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lack of oversight and review of financial reporting;
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lack of internal accounting technical expertise;
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lack of preparation and review and verification of internally developed documentation; and
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lack of executed agreements for significant contracts.
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As part of our
independent auditors’ communications with our audit committee with respect to audit procedures for the year ended December
31, 2011, 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 have begun taking appropriate and reasonable steps, and will continue and complete such steps in due course,
to make the necessary improvements to address these deficiencies, but the timing of such steps is uncertain and the availability
of funding and resources for such steps are also uncertain. Our ability to attract qualified individuals to serve on our Board
and to take on key management roles within the Company is also uncertain. Our failure to successfully complete the remedies of
the existing weaknesses could lead to heightened risk for financial reporting mistakes and irregularities, and/or lead to a loss
of public confidence in our internal controls that could have a negative effect on the market price of our common stock.
We do not intend to pay any
cash dividends in the foreseeable future and, therefore, any return on your investment in our common stock must come from increases
in the market price of our common stock.
We have not
paid any cash dividends on our common stock to date in our history, and we do not intend to pay cash dividends on our common stock
in the foreseeable future. We intend to retain future earnings, if any, for reinvestment in the development and expansion of our
business. Also, any credit agreements which we may enter into with institutional lenders may restrict our ability to pay dividends.
Therefore, any return on your investment in our capital stock must come from increases in the fair market value and trading price
of our common stock. Such increases in the trading price of our stock may not occur.
Our certificate of incorporation
and bylaws, our shareholder rights plan and Delaware law have anti-takeover provisions that could discourage, delay or prevent
a change in control, which may cause our stock price to decline.
Our certificate
of incorporation and bylaws and Delaware law contain provisions which could make it more difficult for a third party to acquire
us, even if closing such a transaction would be beneficial to our stockholders. We are authorized to issue up to 40,000,000 shares
of preferred stock. This preferred stock may be issued in one or more series, the terms of which may be determined at the time
of issuance by our Board of Directors without further action by stockholders. The terms of any series of preferred stock may include
voting rights (including the right to vote as a series on particular matters), preferences as to dividend, liquidation, conversion
and redemption rights and sinking fund provisions. No preferred stock is currently outstanding. The issuance of any preferred stock
could materially adversely affect the rights of the holders of our common stock, and therefore, reduce the value of our common
stock. In particular, specific rights granted to future holders of preferred stock could be used to restrict our ability to merge
with, or sell our assets to, a third party and thereby preserve control by the present management.
Provisions of
our certificate of incorporation and bylaws and Delaware law also could have the effect of discouraging potential acquisition proposals
or making a tender offer or delaying or preventing a change in control, including changes a stockholder might consider favorable.
Such provisions may also prevent or frustrate attempts by our stockholders to replace or remove our management. In particular,
the certificate of incorporation and bylaws and Delaware law, as applicable, among other things:
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provide the Board of Directors with the ability to alter the bylaws without stockholder approval;
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establish staggered terms for board members;
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place limitations on the removal of directors; and
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provide that vacancies on the Board of Directors may be filled by a majority of directors in office, although less than a quorum.
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We expect to
adopt a shareholder rights plan and declare a dividend distribution of one right for each outstanding share of common stock as
fixed by our Board of Directors. Each right, when exercisable, will entitle the registered holder to purchase from us shares of
a new series of preferred stock on the terms stated in the rights plan. The rights will generally separate from the common stock
and become exercisable if any person or group acquires or announces a tender offer to acquire 15% or more of our outstanding common
stock without the consent of our Board of Directors. Because the rights may substantially dilute the stock ownership of a person
or group attempting to take us over without the approval of our Board of Directors, our stockholder rights plan could make it more
difficult for a third party to acquire us (or a significant percentage of our outstanding capital stock) without first negotiating
with our Board of Directors.
We are also
subject to Section 203 of the Delaware General Corporation Law which, subject to certain exceptions, prohibits “business
combinations” between a publicly-held Delaware corporation and an “interested stockholder,” which is generally
defined as a stockholder who becomes a beneficial owner of 15% or more of a Delaware corporation’s voting stock for a three-year
period following the date that such stockholder became an interested stockholder.
These provisions
are expected to discourage certain types of coercive takeover practices and inadequate takeover bids and to encourage persons seeking
to acquire control of our company to first negotiate with its board. These provisions may delay or prevent someone from acquiring
or merging with us, which may cause the market price of our common stock to decline.
SPECIAL NOTE REGARDING FORWARD-LOOKING
STATEMENTS
This prospectus and
any accompanying prospectus supplement, including the documents that we incorporate by reference, contains forward-looking statements.
Such forward-looking statements include those that express plans, anticipation, intent, contingency, goals, targets or future development
and/or otherwise are not statements of historical fact. These forward-looking statements are based on our current expectations
and projections about future events, and they are subject to risks and uncertainties (known and unknown) that could cause actual
results and developments to differ materially from those expressed or implied in such statements, including the following, among
others:
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our ability to raise funds for general corporate purposes and operations, including our clinical trials;
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the commercial feasibility and success of our technology;
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our ability to recruit qualified management and technical personnel;
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our ability to scale up the manufacturing of our product candidates for commercialization;
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the success of our clinical trials;
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our ability to obtain and maintain required regulatory approvals for our products; and
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the other factors discussed in the “Risk Factors” section and elsewhere in this prospectus.
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In some cases,
you can identify forward-looking statements by terminology, such as “expects,” “anticipates,” “intends,”
“estimates,” “plans,” “believes,” “seeks,” “may,” “should”,
“could” or the negative of such terms or other similar expressions. Accordingly, these statements involve estimates,
assumptions and uncertainties that could cause actual results to differ materially from those expressed in them. Any forward-looking
statements are qualified in their entirety by reference to the factors discussed throughout this prospectus.
You should read
this prospectus and any accompanying prospectus supplement and the documents that we reference herein and therein and have filed
as exhibits to the registration statement, of which this prospectus is part, completely and with the understanding that our actual
future results may be materially different from what we expect. You should assume that the information appearing in this prospectus
and any accompanying prospectus is accurate as of the date on the front cover of this prospectus or such prospectus supplement
only. Because the risk factors referred to above could cause actual results or outcomes to differ materially from those expressed
in any forward-looking statements made by us or on our behalf, you should not place undue reliance on any forward-looking statements.
Further, any forward-looking statement speaks only as of the date on which it is made, and we undertake no obligation to update
any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the
occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for us to predict which factors
will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination
of factors, may cause actual results to differ materially from those contained in any forward-looking statements. We qualify all
of the information presented in this prospectus and any accompanying prospectus supplement, and particularly our forward-looking
statements, by these cautionary statements.
USE OF PROCEEDS
Except as otherwise provided in the applicable
prospectus supplement, we intend to use the net proceeds from the sale of the securities offered by this prospectus for general
corporate purposes, which may include working capital, capital expenditures, research and development expenditures, regulatory
affairs expenditures, clinical trial expenditures, acquisitions of new technologies and investments, and the repayment, refinancing,
redemption or repurchase of future indebtedness or capital stock.
The intended application of proceeds from
the sale of any particular offering of securities using this prospectus will be described in the accompanying prospectus supplement
relating to such offering. The precise amount and timing of the application of these proceeds will depend on our funding requirements
and the availability and costs of other funds.
RATIO OF EARNINGS TO FIXED CHARGES
If we offer debt securities under this
prospectus, then we will, if required at that time, provide a ratio of earnings to fixed charges in the applicable prospectus supplement
for such offering.
THE SECURITIES WE MAY OFFER
The descriptions of the securities contained
in this prospectus, together with the applicable prospectus supplements, summarize all the material terms and provisions of the
various types of securities that we may offer. We will describe in the applicable prospectus supplement relating to any securities
the particular terms of the securities offered by that prospectus supplement. If we indicate in the applicable prospectus supplement,
the terms of the securities may differ from the terms we have summarized below. We will also include in the prospectus supplement
information, where applicable, about material United States federal income tax considerations relating to the securities, and the
securities exchange, if any, on which the securities will be listed.
We may sell from time to time, in one or
more offerings:
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shares of our common stock;
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shares
of our preferred stock;
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warrants to purchase any of the securities listed above;
and/or
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units consisting of any of the securities listed above.
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The terms of any securities we offer will
be determined at the time of sale. We may issue securities that are exchangeable for or convertible into common stock or any of
the other securities that may be sold under this prospectus. When particular securities are offered, a supplement to this prospectus
will be filed with the SEC, which will describe the terms of the offering and sale of the offered securities.
DESCRIPTION OF CAPTIAL STOCK
General
The following
description of common stock and preferred stock, together with the additional information we include in any applicable prospectus
supplements, summarizes the material terms and provisions of the common stock and preferred stock that we may offer under this
prospectus but is not complete. For the complete terms of our common stock and preferred stock, please refer to our certificate
of incorporation, as amended, (the “Certificate of Incorporation”) which may be further amended from time to time,
any certificates of designation for our preferred stock, and our amended and restated bylaws, as amended from time to time (the
“Bylaws”). Delaware General Corporation Law (“DGCL”) may also affect the terms of these securities. While
the terms we have summarized below will apply generally to any future common stock or preferred stock that we may offer, we will
describe the particular terms of any series of these securities in more detail in the applicable prospectus supplement. If we so
indicate in a prospectus supplement, the terms of any common stock or preferred stock we offer under that prospectus supplement
may differ from the terms we describe below.
Our
Seventh Amended and Restated Certificate of Incorporation, as amended, authorizes the issuance of 450,000,000 shares of
common stock, $0.001 par value per share and 40,000,000 shares of preferred stock, $0.001 par value per share. As of January
4, 2013, we had 26,370,283 shares of common stock outstanding and no shares of preferred stock outstanding.
The following summary of certain provisions
of our common stock and preferred sotck does not purport to be complete. You should refer to our Seventh Amended and Restated Certificate
of Incorporation, as amended and our Third Amended and Restated Bylaws, as amended. The summary below is also qualified by provisions
of applicable law.
Common Stock
Holders of shares
of common stock are entitled to one vote for each share on all matters to be voted on by the stockholders. Holders of common stock
have no cumulative voting rights. Accordingly, the holders of in excess of 50% of the aggregate number of shares of common stock
outstanding will be able to elect all of our directors and to approve or disapprove any other matter submitted to a vote of all
stockholders.
No shareholder
has any preemptive right or other similar right to purchase or subscribe for any additional securities issued by us. No shareholder
has any right to convert the common stock into other securities. No shares of common stock are subject to redemption or any sinking
fund provisions. All the outstanding shares of our common stock are fully paid and non-assessable. There is no outstanding preferred
stock, and no outstanding securities convertible into or exercisable for preferred stock. Our common stock holders are entitled
to dividends when, as and if declared by the Board from funds legally available therefor, although we do not anticipate declaring
or paying any cash dividends on the common stock in the foreseeable future. Upon liquidation, the common stock holders are entitled
to a pro-rata share in any distribution to shareholders.
Preferred Stock
Our board of directors has the authority,
without further action by the stockholders, to issue up to 40,000,000 shares of preferred stock in one or more series and to fix
the rights, preferences, privileges and restrictions thereof, including dividend rights, conversion rights, voting rights, terms
of redemption, liquidation preferences, sinking fund terms and the number of shares constituting any series or the designation
of such series, without any further vote or action by our stockholders. As of the date of this prospectus, no shares of preferred
stock were outstanding. The issuance of preferred stock could adversely affect the voting power of holders of common stock and
the likelihood that such holders will receive dividend payments and payments upon liquidation and could have the effect of delaying,
deferring or preventing a change in control of our company.
We will fix the rights, preferences, privileges
and restrictions of the preferred stock of each series in the certificate of designation relating to that series. We will file
as an exhibit to the registration statement of which this prospectus is a part, or will incorporate by reference from reports that
we file with the SEC, the form of any certificate of designation that describes the terms of the series of preferred stock we are
offering before the issuance of the related series of preferred stock. This description will include any or all of the following,
as required:
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the title and stated value;
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the number of shares we are offering;
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the liquidation preference per share;
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the dividend rate, period and payment date and method of calculation for dividends;
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whether dividends will be cumulative or non-cumulative and, if cumulative, the date from which dividends will accumulate;
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the procedures for any auction and remarketing, if any;
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the provisions for a sinking fund, if any;
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the provisions for redemption or repurchase, if applicable, and any restrictions on our ability to exercise those redemption and repurchase rights;
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any listing of the preferred stock on any securities exchange or market;
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whether the preferred stock will be convertible into our common stock, and, if applicable, the conversion price, or how it will be calculated, and the conversion period;
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voting rights, if any, of the preferred stock;
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preemptive rights, if any;
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restrictions on transfer, sale or other assignment, if any;
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whether interests in the preferred stock will be represented by depositary shares;
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a discussion of any material or special United States federal income tax considerations applicable to the preferred stock;
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the relative ranking and preferences of the preferred stock as to dividend rights and rights if we liquidate, dissolve or wind up our affairs;
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any limitations on issuance of any class or series of preferred stock ranking senior to or on a parity with the series of preferred stock as to dividend rights and rights if we liquidate, dissolve or wind up our affairs; and
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any other specific terms, preferences, rights or limitations of, or restrictions on, the preferred stock.
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If we issue shares of preferred stock under
this prospectus, the shares will be fully paid and non-assessable.
The DGCL provides that the holders of preferred
stock will have the right to vote separately as a class on any proposal involving fundamental changes in the rights of holders
of that preferred stock. This right is in addition to any voting rights that may be provided for in the applicable certificate
of designation.
Our board of directors may authorize the
issuance of preferred stock with voting or conversion rights that could adversely affect the voting power or other rights of the
holders of our common stock. Preferred stock could be issued quickly with terms designed to delay or prevent a change in control
of our company or make removal of management more difficult. Additionally, the issuance of preferred stock may have the effect
of decreasing the market price of our common stock.
Transfer Agent and Registrar
The transfer agent and registrar for our
common stock is Computershare Shareowner Services.
Anti-Takeover Effects of Certain Provisions of our
Certificate of Incorporation, Bylaws and the DGCL
Certain provisions of DGCL and
our Amended and Restated Certificate of Incorporation, as amended and Amended and Restated Bylaws, as amended discussed below may
have the effect of making more difficult or discouraging a tender offer, proxy contest or other takeover attempt. These provisions
are expected to encourage persons seeking to acquire control of our company to first negotiate with our board of directors. We
believe that the benefits of increasing our ability to negotiate with the proponent of an unfriendly or unsolicited proposal to
acquire or restructure our company outweigh the disadvantages of discouraging these proposals because negotiation of these proposals
could result in an improvement of their terms.
Delaware Anti-takeover Law
We are subject to Section 203 of the DGCL,
an anti-takeover law. In general, Section 203 prohibits a publicly held Delaware corporation from engaging in a “business
combination” with an “interested stockholder” for a period of three years following the date the person became
an interested stockholder, unless:
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the board of directors approves the transaction in which the stockholder became an interested stockholder prior to the date the interested stockholder attained that status;
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when the stockholder became an interested stockholder, he or she owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding shares owned by persons who are directors and also officers and certain shares owned by employee benefits plans; or
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on or subsequent to the date the business combination is approved by the board of directors, the business combination is authorized by the affirmative vote of at least 66 2/3% of the voting stock of the corporation at an annual or special meeting of stockholders.
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Generally, a “business combination”
includes a merger, asset or stock sale, or other transaction resulting in a financial benefit to the interested stockholder. Generally,
an “interested stockholder” is a person who, together with affiliates and associates, owns, or is an affiliate or associate
of the corporation and within three years prior to the determination of interested stockholder status did own, 15% or more of a
corporation’s voting stock.
The existence of Section 203 of the DGCL
would be expected to have an anti-takeover effect with respect to transactions not approved in advance by our board of directors,
including discouraging attempts that might result in a premium over the market price for the shares of our common stock.
Rights Plan
We expect to
adopt a shareholder rights plan and declare a dividend distribution of one right for each outstanding share of common stock as
fixed by our Board of Directors. Each right, when exercisable, will entitle the registered holder to purchase from us shares of
a new series of preferred stock on the terms stated in the rights plan. The rights will generally separate from the common stock
and become exercisable if any person or group acquires or announces a tender offer to acquire 15% or more of our outstanding common
stock without the consent of our Board of Directors. Because the rights may substantially dilute the stock ownership of a person
or group attempting to take us over without the approval of our Board of Directors, our stockholder rights plan could make it more
difficult for a third party to acquire us (or a significant percentage of our outstanding capital stock) without first negotiating
with our Board of Directors.
Amended and Restated Certificate
of Incorporation and Bylaw Provisions
Our Seventh
Amended and Restated Certificate of Incorporation, as amended and bylaws contain provisions that could have the effect of discouraging
potential acquisition proposals or making a tender offer or delaying or preventing a change in control, including changes a stockholder
might consider favorable. In particular, the certificate of incorporation and bylaws, as applicable, among other things:
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provide a staggered Board of Directions with three classes of directors;
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provide our Board of Directors with the ability to alter its bylaws without stockholder approval; and
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provide that vacancies on our Board of Directors may be filled by a majority of directors in office, although less than a quorum.
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Such provisions
may have the effect of discouraging a third-party from acquiring us, even if doing so would be beneficial to our stockholders.
These provisions are intended to enhance the likelihood of continuity and stability in the composition of our Board of Directors
and in the policies formulated by them, and to discourage some types of transactions that may involve an actual or threatened change
in control of our company. These provisions are designed to reduce our vulnerability to an unsolicited acquisition proposal and
to discourage some tactics that may be used in proxy fights. We believe that the benefits of increased protection of our potential
ability to negotiate with the proponent of an unfriendly or unsolicited proposal to acquire or restructure our company outweigh
the disadvantages of discouraging such proposals because, among other things, negotiation of such proposals could result in an
improvement of their terms.
However, these
provisions could have the effect of discouraging others from making tender offers for our shares that could result from actual
or rumored takeover attempts. These provisions also may have the effect of preventing changes in our management.
DESCRIPTION OF DEBT SECURITIES
The following description, together with
the additional information we include in any applicable prospectus supplement, summarizes the material terms and provisions of
any debt securities that we may offer under this prospectus. While the terms we have summarized below will apply generally to any
future debt securities we may offer, we will describe the particular terms of any debt securities that we may offer in more detail
in the applicable prospectus supplement. The terms of any debt securities we may offer under a prospectus supplement may differ
from the terms described below. For any debt securities that we may offer, an indenture (and any relevant supplemental indenture)
will contain additional important terms and provisions and will be incorporated by reference as an exhibit to the registration
statement that includes this prospectus, or as an exhibit to reports that we file with the SEC and incorporated by reference in
this prospectus.
With respect to any debt securities that
we issue, we will issue such debt securities under an indenture, which we would enter into with the trustee named in the indenture.
Any indenture would be qualified under the Trust Indenture Act of 1939.
With respect to any debt securities that we issue, we will describe
in each prospectus supplement the following terms relating to a series of debt securities:
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the principal amount being offered, and if a series, the total amount
authorized and the total amount outstanding;
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any limit on the amount that may be issued;
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whether or not we will issue the series of debt securities in global form, and if so, the terms and who the depository will be;
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the principal amount due at maturity;
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whether and under what circumstances, if any, we will pay additional amounts on any debt securities held by a person who is not a United States person for tax purposes, and whether we can redeem the debt securities if we have to pay such additional amounts;
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the
annual interest rate, which may be fixed or variable, or the method for determining the rate and the date interest will begin to accrue, the dates interest will be payable and the regular record dates for interest payment dates or the method for determining such dates;
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whether or not the debt securities will be convertible
into shares of our common stock or our preferred stock and, if so, the terms of such conversion;
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whether
or not the debt securities will be secured or unsecured by some or all of our assets, and the terms of any secured debt;
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the
terms of the subordination of any series of subordinated debt;
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the
place where payments will be payable;
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estrictions on transfer, sale or other assignment, if any;
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our right, if any, to defer payment or interest and the maximum length of any such deferral period;
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the date, if any, after which and the conditions upon which, and the price at which, we may, at our option, redeem the series of debt securities pursuant to any optional or provisional redemption provisions and the terms of those redemptions provisions;
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the date, if any, on which, and the price at which we are obligated, pursuant to any mandatory sinking fund or analogous fund provisions or otherwise, to redeem, or at the holder’s option to purchase, the series of debt securities and the currency or currency unit in which the debt securities are payable;
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whether
the indenture will restrict our ability to pay dividends, or will require us to maintain any asset ratios or reserves;
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whether we will be restricted from incurring any additional indebtedness, issuing additional securities, or entering into a merger, consolidation or sale of our business;
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a discussion of any material or special United States federal income tax considerations applicable to the debt securities;
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information describing any book-entry features;
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any
provisions for payment of additional amounts for taxes;
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whether the debt securities are to be offered at a price such that they will be deemed to be offered at an “original issue discount” as defined in paragraph (a) of Section 1273 of the Internal Revenue Code of 1986, as amended;
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the denominations in which we will issue the series of debt securities, if other than denominations of $1,000 and any integral multiple thereof;
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whether
we and/or the debenture trustee may change an indenture without the consent of any holders;
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the
form of debt security and how it may be exchanged and transferred;
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description of the debenture trustee and paying agent, and the method of payments; and
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any other specified terms, preferences, rights or limitations of, or restrictions on, the debt securities and any terms that may be required by us or advisable under applicable laws or regulations.
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DESCRIPTION OF WARRANTS
The following description, together with
the additional information we may include in any applicable prospectus supplements, summarizes the material terms and provisions
of the warrants that we may offer under this prospectus and the related warrant agreements and warrant certificates. While the
terms summarized below will apply generally to any warrants that we may offer, we will describe the particular terms of any series
of warrants in more detail in the applicable prospectus supplement. If we indicate in the prospectus supplement, the terms of any
warrants offered under that prospectus supplement may differ from the terms described below. If there are differences between
that prospectus supplement and this prospectus, the prospectus supplement will control. Thus, the statements we make in this
section may not apply to a particular series of warrants. Specific warrant agreements will contain additional important terms
and provisions and will be incorporated by reference as an exhibit to the registration statement which includes this prospectus.
General
We may issue warrants for the purchase
of common stock and/or preferred stock and/or debt securities in one or more series. We may issue warrants independently or together
with common stock and/or preferred stock and/or debt securities, and the warrants may be attached to or separate from these securities.
We will evidence each series of warrants
by warrant certificates that we may issue under a separate agreement. We may enter into the warrant agreement with a warrant agent.
Each warrant agent may be a bank that we select which has its principal office in the United States and a combined capital and
surplus of at least $50,000,000. We may also choose to act as out own warrant agent. We will indicate the name and
address of any such warrant agent in the applicable prospectus supplement relating to a particular series of warrants.
We will describe in the applicable
prospectus supplement the terms of the series of warrants, including:
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the offering price and aggregate number of warrants offered;
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the currency for which the warrants may be purchased;
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in the case of warrants to purchase debt securities, the principal amount of debt securities purchasable upon exercise of one
warrant and the price at, and currency in which, this principal amount of debt securities may be purchased upon such exercise;
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if applicable, the designation and terms of the securities
with which the warrants are issued and the number of warrants issued with each such security or each principal amount of such
security;
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if applicable, the date on and after which the warrants
and the related securities will be separately transferable;
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in the case of warrants to purchase common stock or preferred
stock, the number of shares of common stock or preferred stock, as the case may be, purchasable upon the exercise of one warrant
and the price at which these shares may be purchased upon such exercise;
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the warrant agreement under which the warrants will be
issued;
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the effect of any merger, consolidation, sale or other
disposition of our business on the warrant agreement and the warrants;
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anti-dilution provisions of the warrants, if any;
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the terms of any rights to redeem or call the warrants;
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any provisions for changes to or adjustments in the exercise
price or number of securities issuable upon exercise of the warrants;
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the dates on which the right to exercise the warrants
will commence and expire or, if the warrants are not continuously exercisable during that period, the specific date or dates on
which the warrants will be exercisable;
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·
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the manner in which the warrant agreement and warrants
may be modified;
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·
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the identities of the warrant agent and any calculation
or other agent for the warrants;
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·
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federal income tax consequences of holding or exercising
the warrants;
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·
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the terms of the securities issuable upon exercise of
the warrants;
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·
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any securities exchange or quotation system on which
the warrants or any securities deliverable upon exercise of the warrants may be listed; and
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·
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any other specific terms, preferences, rights or limitations
of or restrictions on the warrants.
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Before exercising their warrants, holders
of warrants will not have any of the rights of holders of the securities purchasable upon such exercise, including:
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·
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in the case of warrants to purchase common stock or preferred stock, the right to receive dividends, if any, or, payments upon
our liquidation, dissolution or winding up or to exercise voting rights, if any; or
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·
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in the case of warrants to purchase debt securities, the right to
receive payments of principal of, or premium, if any, or interest on, the debt securities purchasable upon exercise or to enforce
covenants in the applicable indenture.
|
Exercise of Warrants
Each warrant will entitle the holder to
purchase the securities that we specify in the applicable prospectus supplement at the exercise price that we describe in the applicable
prospectus supplement. Unless we otherwise specify in the applicable prospectus supplement, holders of the warrants may exercise
the warrants at any time up to 5:00 p.m. Eastern Time on the expiration date that we set forth in the applicable prospectus
supplement. After the close of business on the expiration date, unexercised warrants will become void.
Holders of the warrants may exercise the
warrants by delivering the warrant certificate representing the warrants to be exercised together with specified information, and
paying the required amount to the warrant agent in immediately available funds, as provided in the applicable prospectus supplement.
We will set forth on the reverse side of the warrant certificate, and in the applicable prospectus supplement, the information
that the holder of the warrant will be required to deliver to the warrant agent.
Until the warrant is properly exercised,
no holder of any warrant will be entitled to any rights of a holder of the securities purchasable upon exercise of the warrant.
Upon receipt of the required payment and
the warrant certificate properly completed and duly executed at the corporate trust office of the warrant agent or any other office
indicated in the applicable prospectus supplement, we will issue and deliver the securities purchasable upon such exercise. If
fewer than all of the warrants represented by the warrant certificate are exercised, then we will issue a new warrant certificate
for the remaining amount of warrants. If we so indicate in the applicable prospectus supplement, holders of the warrants may surrender
securities as all or part of the exercise price for warrants.
Enforceability of Rights By Holders of Warrants
Any warrant agent will act solely as our
agent under the applicable warrant agreement and will not assume any obligation or relationship of agency or trust with any holder
of any warrant. A single bank or trust company may act as warrant agent for more than one issue of warrants. A warrant agent will
have no duty or responsibility in case of any default by us under the applicable warrant agreement or warrant, including any duty
or responsibility to initiate any proceedings at law or otherwise, or to make any demand upon us. Any holder of a warrant may,
without the consent of the related warrant agent or the holder of any other warrant, enforce by appropriate legal action its right
to exercise, and receive the securities purchasable upon exercise of, its warrants in accordance with their terms.
Warrant Agreement Will Not Be Qualified Under Trust Indenture
Act
No warrant agreement will be qualified
as an indenture, and no warrant agent will be required to qualify as a trustee, under the Trust Indenture Act. Therefore, holders
of warrants issued under a warrant agreement will not have the protection of the Trust Indenture Act with respect to their warrants.
Governing Law
Each warrant agreement and any warrants
issued under the warrant agreements will be governed by New York law.
Calculation Agent
Calculations relating to warrants may be
made by a calculation agent, an institution that we appoint as our agent for this purpose. The prospectus supplement for
a particular warrant will name the institution that we have appointed to act as the calculation agent for that warrant as of the
original issue date for that warrant. We may appoint a different institution to serve as calculation agent from time to time after
the original issue date without the consent or notification of the holders.
The calculation agent’s determination
of any amount of money payable or securities deliverable with respect to a warrant will be final and binding in the absence of
manifest error.
DESCRIPTION OF UNITS
We may issue units comprised of one or
more of the other securities described in this prospectus in any combination. Each unit will be issued so that the holder of the
unit is also the holder of each security included in the unit. Thus, the holder of a unit will have the rights and obligations
of a holder of each included security. The unit agreement under which a unit is issued may provide that the securities included
in the unit may not be held or transferred separately, at any time or at any time before a specified date.
The applicable prospectus supplement will
describe:
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·
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the designation and terms of the units and of the securities
comprising the units, including whether and under what circumstances those securities may be held or transferred separately;
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|
·
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any unit agreement under which the units will be issued;
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·
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any provisions for the issuance, payment, settlement,
transfer or exchange of the units or of the securities comprising the units; and
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·
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whether the units will be issued in fully registered
or global form.
|
The applicable prospectus supplement will
describe the terms of any units. The preceding description and any description of units in the applicable prospectus supplement
does not purport to be complete and is subject to and is qualified in its entirety by reference to the unit agreement and, if applicable,
collateral arrangements and depositary arrangements relating to such units.
PLAN OF DISTRIBUTION
We may sell the securities being offered
pursuant to this prospectus through underwriters or dealers, through agents, or directly to one or more purchasers or through a
combination of these methods. The applicable prospectus supplement will describe the terms of the offering of the securities,
including:
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·
|
the name or names of any underwriters, if any, and if
required, any dealers or agents;
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|
·
|
the purchase price of the securities and the proceeds
we will receive from the sale;
|
|
·
|
any underwriting discounts and other items constituting
underwriters’ compensation;
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|
·
|
any discounts or concessions allowed or reallowed or
paid to dealers; and
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·
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any securities exchange or market on which the securities
may be listed.
|
We may distribute the securities from time
to time in one or more transactions at:
|
·
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a fixed price or prices, which may be changed;
|
|
·
|
market prices prevailing at the time of sale;
|
|
·
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prices related to such prevailing market prices; or
|
Only underwriters named in the prospectus
supplement are underwriters of the securities offered by the prospectus supplement.
If underwriters are
used in an offering, we will execute an underwriting agreement with such underwriters and will specify the name of each underwriter
and the terms of the transaction (including any underwriting discounts and other terms constituting compensation of the underwriters
and any dealers) in a prospectus supplement. The securities may be offered to the public either through underwriting syndicates
represented by managing underwriters or directly by one or more investment banking firms or others, as designated. If an underwriting
syndicate is used, the managing underwriter(s) will be specified on the cover of the prospectus supplement. If underwriters
are used in the sale, the offered securities will be acquired by the underwriters for their own accounts and may be resold from
time to time in one or more transactions, including negotiated transactions, at a fixed public offering price or at varying prices
determined at the time of sale. Any public offering price and any discounts or concessions allowed or reallowed or paid to dealers
may be changed from time to time. Unless otherwise set forth in the prospectus supplement, the obligations of the underwriters
to purchase the offered securities will be subject to conditions precedent and the underwriters will be obligated to purchase all
of the offered securities if any are purchased.
We may grant to the
underwriters options to purchase additional securities to cover over-allotments, if any, at the public offering price, with additional
underwriting commissions or discounts, as may be set forth in a related prospectus supplement. The terms of any over-allotment
option will be set forth in the prospectus supplement for those securities.
If we use a dealer
in the sale of the securities being offered pursuant to this prospectus or any prospectus supplement, we will sell the securities
to the dealer, as principal. The dealer may then resell the securities to the public at varying prices to be determined by
the dealer at the time of resale. The names of the dealers and the terms of the transaction will be specified in a prospectus
supplement.
We may sell the securities
directly or through agents we designate from time to time. We will name any agent involved in the offering and sale of securities
and we will describe any commissions we will pay the agent in the prospectus supplement. Unless the prospectus supplement states
otherwise, any agent will act on a best-efforts basis for the period of its appointment.
We may authorize agents
or underwriters to solicit offers by institutional investors to purchase securities from us at the public offering price set forth
in the prospectus supplement pursuant to delayed delivery contracts providing for payment and delivery on a specified date in the
future. We will describe the conditions to these contracts and the commissions we must pay for solicitation of these contracts
in the prospectus supplement.
In connection with
the sale of the securities, underwriters, dealers or agents may receive compensation from us or from purchasers of the common stock
for whom they act as agents in the form of discounts, concessions or commissions. Underwriters may sell the securities to or through
dealers, and those dealers may receive compensation in the form of discounts, concessions or commissions from the underwriters
or commissions from the purchasers for whom they may act as agents. Underwriters, dealers and agents that participate in the distribution
of the securities, and any institutional investors or others that purchase common stock directly and then resell the securities,
may be deemed to be underwriters, and any discounts or commissions received by them from us and any profit on the resale of the
common stock by them may be deemed to be underwriting discounts and commissions under the Securities Act.
We may provide agents
and underwriters with indemnification against particular civil liabilities, including liabilities under the Securities Act, or
contribution with respect to payments that the agents or underwriters may make with respect to such liabilities. Agents and underwriters
may engage in transactions with, or perform services for, us in the ordinary course of business.
In addition, we may
enter into derivative transactions with third parties (including the writing of options), or sell securities not covered by this
prospectus to third parties in privately negotiated transactions. If the applicable prospectus supplement indicates, in connection
with such a transaction, the third parties may, pursuant to this prospectus and the applicable prospectus supplement, sell securities
covered by this prospectus and the applicable prospectus supplement. If so, the third party may use securities borrowed from us
or others to settle such sales and may use securities received from us to close out any related short positions. We may also loan
or pledge securities covered by this prospectus and the applicable prospectus supplement to third parties, who may sell the loaned
securities or, in an event of default in the case of a pledge, sell the pledged securities pursuant to this prospectus and the
applicable prospectus supplement. The third party in such sale transactions will be an underwriter and will be identified in the
applicable prospectus supplement or in a post-effective amendment.
To facilitate an offering
of a series of securities, persons participating in the offering may engage in transactions that stabilize, maintain, or otherwise
affect the market price of the securities. This may include over-allotments or short sales of the securities, which involves the
sale by persons participating in the offering of more securities than have been sold to them by us. In those circumstances, such
persons would cover such over-allotments or short positions by purchasing in the open market or by exercising the over-allotment
option granted to those persons. In addition, those persons may stabilize or maintain the price of the securities by bidding for
or purchasing securities in the open market or by imposing penalty bids, whereby selling concessions allowed to underwriters or
dealers participating in any such offering may be reclaimed if securities sold by them are repurchased in connection with stabilization
transactions. The effect of these transactions may be to stabilize or maintain the market price of the securities at a level above
that which might otherwise prevail in the open market. Such transactions, if commenced, may be discontinued at any time. We make
no representation or prediction as to the direction or magnitude of any effect that the transactions described above, if implemented,
may have on the price of our securities.
Any common stock sold
pursuant to a prospectus supplement will be eligible for quotation and trading on The NASDAQ Capital Market. Any underwriters to
whom securities are sold by us for public offering and sale may make a market in the securities, but such underwriters will not
be obligated to do so and may discontinue any market making at any time without notice.
In order to comply
with the securities laws of some states, if applicable, the securities offered pursuant to this prospectus will be sold in those
states only through registered or licensed brokers or dealers. In addition, in some states securities may not be sold unless they
have been registered or qualified for sale in the applicable state or an exemption from the registration or qualification requirement
is available and complied with.
In compliance with
guidelines of the Financial Industry Regulatory Authority, or FINRA, the maximum consideration or discount to be received by any
FINRA member or independent broker dealer may not exceed 8% of the aggregate amount of the securities offered pursuant to this
prospectus and any applicable prospectus supplement.
LEGAL MATTERS
The validity of the securities being offered
hereby will be passed upon by Sichenzia Ross Friedman Ference LLP, New York, New York.
EXPERTS
Our financial
statements incorporated by reference into this prospectus as of and for the fiscal years ended December 31, 2011 and 2010 (as
indicated in their reports) have been audited by Peterson Sullivan LLP, Seattle, Washington, an independent registered public
accounting firm and are included herein in reliance upon the authority as experts in giving said reports.
WHERE YOU CAN FIND MORE INFORMATION
This prospectus constitutes a part of a
registration statement on Form S-3 filed under the Securities Act. As permitted by the SEC’s rules, this prospectus
and any prospectus supplement, which form a part of the registration statement, do not contain all the information that is included
in the registration statement. You will find additional information about us in the registration statement. Any statements
made in this prospectus or any prospectus supplement concerning legal documents are not necessarily complete and you should read
the documents that are filed as exhibits to the registration statement or otherwise filed with the SEC for a more complete understanding
of the document or matter.
We file annual, quarterly and current reports,
proxy statements and other information with the SEC. You may read, without charge, and copy the documents we file at the
SEC’s public reference rooms in Washington, D.C. at 100 F Street, NE, Room 1580, Washington, DC 20549, or in New York,
New York and Chicago, Illinois. You can request copies of these documents by writing to the SEC and paying a fee for
the copying cost. Please call the SEC at 1-800-SEC-0330 for further information on the public reference rooms. Our
SEC filings are also available to the public at no cost from the SEC’s website at http://www.sec.gov.
INCORPORATION OF DOCUMENTS BY REFERENCE
We have filed a registration statement
on Form S-3 with the Securities and Exchange Commission under the Securities Act. This prospectus is part of the registration
statement but the registration statement includes and incorporates by reference additional information and exhibits. The Securities
and Exchange Commission permits us to “incorporate by reference” the information contained in documents we file with
the Securities and Exchange Commission, which means that we can disclose important information to you by referring you to those
documents rather than by including them in this prospectus. Information that is incorporated by reference is considered to be part
of this prospectus and you should read it with the same care that you read this prospectus. Information that we file later with
the Securities and Exchange Commission will automatically update and supersede the information that is either contained, or incorporated
by reference, in this prospectus, and will be considered to be a part of this prospectus from the date those documents are filed.
We have filed with the Securities and Exchange Commission, and incorporate by reference in this prospectus:
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our Annual Report on Form 10-K for the fiscal year ended December 31, 2011, filed with the SEC pursuant to Section 13 of the Exchange Act on April 13, 2012, respectively;
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·
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our Quarterly Report on Form 10-Q for the three-month period ended March 31, 2012, filed with the SEC pursuant to Section 13 of the Exchange Act on May 21, 2012;
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·
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our Quarterly Report on Form 10-Q and Form 10-Q/A for the six-month period ended June 30, 2012, filed with the SEC pursuant to Section 13 of the Exchange Act on August 14 and September 12, 2012, respectively;
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our Quarterly Report on Form 10-Q for the nine-month period ended September 30, 2012, filed with the SEC pursuant to Section 13 of the Exchange Act on November 14, 2012;
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our Current Reports on Form 8-K, filed with the SEC pursuant to Section 13 of the Exchange Act on February 6, 2012, February 15, 2012, April 6, 2012, April 17, 2012, May 23, 2012, July 20, 2012, August 23, 2012, August 31, 2012, September 17, 2012, September 26, 2012, October 3, 2012, and December 11, 2012;
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the description of our common stock contained in our registration statement on Form 8-A (File No. 001-35737) filed with the SEC on November 14, 2012, including any amendment or report filed for the purpose of updating such description ; and
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We also incorporate by reference
all additional documents that we file with the Securities and Exchange Commission under the terms of Sections 13(a), 13(c), 14
or 15(d) of the Exchange Act that are made after the initial filing date of the registration statement of which this prospectus
is a part until the offering of the particular securities covered by a prospectus supplement or term sheet has been completed.
We are not, however, incorporating, in each case, any documents or information that we are deemed to furnish and not file in accordance
with Securities and Exchange Commission rules.
You may request, and we will provide you
with, a copy of these filings, at no cost, by calling us at (240) 497-9024 or by writing to us at the following address:
Northwest Biotherapeutics, Inc.
4800 Montgomery Lane, Suite 800
Bethesda, MD 20814
Attention: Secretary
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14.
Other Expenses of Issuance and Distribution.
We estimate that expenses payable by us
in connection with the offering described in this registration statement will be as follows:
SEC registration fee
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$
|
13,640
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|
Legal fees and expenses
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$
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20,000
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*
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Accounting fees and expenses
|
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$
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10,000
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*
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Printing expenses
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$
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5,000
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*
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Miscellaneous
|
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$
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1,360
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*
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Total
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$
|
55,000
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*
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*
Estimated as permitted under Item 511 of Regulation
S-K.
Item 15.
Indemnification of Directors and Officers.
Section 145
of the Delaware General Corporation Law provides that a corporation may indemnify directors and officers as well as other employees
and individuals against expenses including attorneys’ fees, judgments, fines and amounts paid in settlement in connection
with various actions, suits or proceedings, whether civil, criminal, administrative or investigative other than an action by or
in the right of the corporation, a derivative action, if they acted in good faith and in a manner they reasonably believed to be
in or not opposed to the best interests of the corporation, and, with respect to any criminal action or proceeding, if they had
no reasonable cause to believe their conduct was unlawful. A similar standard is applicable in the case of derivative actions,
except that indemnification only extends to expenses including attorneys’ fees incurred in connection with the defense or
settlement of such actions, and the statute requires court approval before there can be any indemnification where the person seeking
indemnification has been found liable to the corporation. The statute provides that it is not exclusive of other indemnification
that may be granted by a corporation’s certificate of incorporation, bylaws, agreement, a vote of stockholders or disinterested
directors or otherwise.
Our Seventh
Amended and Restated Certificate of Incorporation, as amended or the Certificate of Incorporation provides that no director will
be personally liable to the company or its stockholders for monetary damages for breach of a fiduciary duty as a director, except
to the extent such exemption or limitation of liability is not permitted under the Delaware General Corporation Law. The effect
of this provision in the Certificate of Incorporation is to eliminate the rights of the company and its stockholders, either directly
or through stockholders’ derivative suits brought on behalf of the company, to recover monetary damages from a director for
breach of the fiduciary duty of care as a director except in those instances described under the Delaware General Corporation Law.
The Delaware
General Corporation Law permits a corporation to provide in its certificate of incorporation that a director of the corporation
shall not be personally liable to the corporation or its stockholders for monetary damages for breach of fiduciary duty as a director,
except for liability for:
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any breach of the director’s duty of loyalty to the corporation or its stockholders;
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·
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acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law;
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·
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payments of unlawful dividends or unlawful stock repurchases or redemptions; or
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·
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any transaction from which the director derived an improper personal benefit.
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Item 16. Exhibits.
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(a)
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The following exhibits are filed as part of this Registration Statement:
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Exhibit
Number
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Description of Document
|
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1.1
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Form of Underwriting Agreement.*
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3.1
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Seventh Amended and Restated Certificate of Incorporation (incorporated by reference to exhibit 3.1 filed with the Registrant’s Amendment No. 1 to the Registration Statement on Form S-1(File No. 333-134320) on July 17, 2006)
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3.2
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Third Amended and Restated Bylaws of the Company (incorporated by reference to exhibit 3.1 filed with the Registrant’s Current Report on Form 8-K on June 22, 2007)
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3.3
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Amendment to Seventh Amended and Restated Certificate of Incorporation (incorporated by reference to exhibit 3.2 filed with the Registrant’s Current Report on Form 8-K on June 22, 2007)
|
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3.4
|
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Amendment to Seventh Amended and Restated Certificate of Incorporation (incorporated by reference to exhibit 3.4 filed with Post-Effective Amendment No. 2 to the Registrant’s Registration Statement on Form S-1 on January 28, 2008)
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3.5
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Amendment to Seventh Amended and Restated Certificate of Incorporation (incorporated by reference to exhibit 3.1 filed with the Registrant’s Quarterly Report on Form 10-Q on May 21, 2012)
|
|
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3.6
|
|
Amendment to Seventh Amended and Restated Certificate of Incorporation (incorporated by reference to exhibit 3.1 filed with the Registrant’s Current Report on Form 8-K on September 26, 2012).
|
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3.7
|
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Amendment to Bylaws (incorporated by reference to the Registrant’s current report on Form 8-K filed with the SEC on December 11, 2012)
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4.1
|
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Specimen Common Stock Certificate
(incorporated by reference to exhibit 4.1 filed with the Registrant’s Amendment No. 3 to the Registration Statement on Form
S-1 on November 14, 2001)
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4.2
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|
Form of Common Stock Warrant Agreement
and Warrant Certificate*
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4.3
|
|
Form of Preferred Stock Certificate and
Form of Certificate of Designation.*
|
|
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4.4
|
|
Form of Indenture*
|
|
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4.5
|
|
Form of Note.*
|
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4.6
|
|
Form of Preferred Stock Warrant Agreement and Warrant Certificate.*
|
|
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4.7
|
|
Form of Debt Securities Warrant Agreement and Warrant Certificate.*
|
|
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4.8
|
|
Form of Unit Agreement and Unit Certificate.*
|
|
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5.1
|
|
Opinion of Sichenzia Ross Friedman Ference
LLP†
|
|
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|
12.1
|
|
Computation of Ratio of Earnings to Fixed
Charges*
|
|
|
|
23.1
|
|
Consent of Peterson Sullivan LLP
|
|
|
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23.2
|
|
Consent of Sichenzia Ross Friedman Ference
LLP (contained in Exhibit 5.1).†
|
|
|
|
24.1
|
|
Power of Attorney (included in the signature
pages hereto).
|
|
|
|
25.1
|
|
Statement of Eligibility of Trustee*
|
____________________________________
|
*
|
To be filed by amendment or by a Current Report on Form 8-K and incorporated by reference herein.
|
|
†
|
To be filed by amendment.
|
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;
(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 SEC pursuant to Rule 424(b) if, in the aggregate, the changes in
volume and price represent no more than a 20% change in the maximum aggregate offering price set forth in the “Calculation
of Registration Fee” table in the effective registration statement;
(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;
provided, however,
that paragraphs (a)(1)(i), (a)(1)(ii)
and (a)(1)(iii) above do not apply if the information required to be included in a post-effective amendment by those paragraphs
is contained in reports filed with or furnished to the Commission by the registrant pursuant to Section 13 and Section 15(d) of
the Securities Exchange Act of 1934 that are incorporated by reference in the registration statement, or is contained in a form
of prospectus filed pursuant to Rule 424(b) that is part of the registration statement.
(2) That, for the purpose 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 of 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.
(4) That, for the purpose of determining
liability under the Securities Act of 1933 to any purchaser:
(i) Each prospectus filed by the Registrant
pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was
deemed part of and included in the registration statement; and
(ii) Each prospectus required to be filed
pursuant to Rule 424(b)(2), (b)(5) or (b)(7) as part of a registration statement in reliance on Rule 430B relating to
an offering made pursuant to Rule 415(a)(1)(i), (vii) or (x) for the purpose of providing the information required by
Section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement as of the
earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities
in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person
that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating
to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that
time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration
statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by
reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with
a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement
or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date.
(5) That, for the purpose of determining
liability of the Registrant under the Securities Act of 1933 to any purchaser in the initial distribution of the securities:
The undersigned Registrant undertakes that
in a primary offering of securities of the undersigned Registrant pursuant to this Registration Statement, regardless of the underwriting
method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of
the following communications, the undersigned Registrant will be a seller to the purchaser and will be considered to offer or sell
such securities to such purchaser:
(i) Any preliminary prospectus or prospectus
of the undersigned Registrant relating to the offering required to be filed pursuant to Rule 424;
(ii) Any free writing prospectus relating
to the offering prepared by or on behalf of the undersigned Registrant or used or referred to by the undersigned Registrant;
(iii) The portion of any other free writing
prospectus relating to the offering containing material information about the undersigned Registrant or its securities provided
by or on behalf of the undersigned Registrant; and
(iv) Any other communication that is an
offer in the offering made by the undersigned Registrant to the purchaser.
(b) The undersigned Registrant hereby undertakes that, for purposes
of determining any liability under the Securities Act of 1933, each filing of the Registrant’s annual report pursuant to
Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit
plan’s annual report pursuant to Section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference
in the registration statement 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.
(c) 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.
(d) To file an application for the purpose of determining
the eligibility of the trustee to act under subsection (a) of section 310 of the Trust Indenture Act
(“Act”) in accordance with the rules and regulations prescribed by the Commission under section 305(b)(2) of
the Act.
SIGNATURES
Pursuant to the requirements of the Securities
Act of 1933, the Registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing
on Form S-3 and has duly caused this Registration Statement on Form S-3 to be signed on its behalf by the undersigned, thereunto
duly authorized, in the City of Bethesda, State of Maryland, on January 4, 2013.
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Northwest Biotherapeutics, Inc.
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By:
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/s/ Linda Powers
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Linda Powers
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Chief Executive Officer (Principal Executive
Officer and Principal Financial and Accounting
Officer) and Chairperson
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POWER OF ATTORNEY
Know all persons by these presents that
each individual whose signature appears below constitutes and appoints Linda Powers, our Chairperson, Chief Executive Officer and
a director, as a true and lawful attorney-in-fact and agent, with full power of substitution and re-substitution, for him and in
his name, place and stead, in any and all capacities, to sign any and all amendments (including post-effective amendments) to this
registration statement, and to sign any registration statement for the same offering covered by this registration statement that
is to be effective upon filing under Rule 462 promulgated under the Securities Act of 1933, and all post-effective amendments thereto,
and to file the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission,
granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act
and thing requisite or necessary to be done in and about the premises, as fully to all intents and purposes as he might or could
do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or any one of them, or his or their substitutes,
may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities
Act of 1933, this Registration Statement on Form S-3 has been signed by the following persons in the capacities and on the dates
indicated.
Signature
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Title
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Date
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/s/ Linda Powers
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Chief Executive Officer (Principal Executive Officer and Principal Financial and Accounting Officer) and Chairperson
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January 4, 2013
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Linda Powers
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/s/ Alton Boynton
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Chief Scientific Officer and Director
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January 4, 2013
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Alton Boynton
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/s/ Robert Farmer
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Director
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January 4, 2013
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Robert Farmer
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/s/ Dr. Navid Malid
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Director
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January 4, 2013
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Dr. Navid Malik
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/s/ Jerry Jasinowski
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Director
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January 4, 2013
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Jerry Jasinowski
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