Filed
Pursuant to Rule 424(b)(3)
Registration
No. 333-154732
PROSPECTUS
12,235,532
Shares
Common
Stock
This prospectus relates to the resale from time to time of up to 12,235,532
shares of our outstanding common stock in the aggregate, including shares of
our
common stock issuable upon the exercise of warrants, which were issued to the
selling stockholders named in this prospectus and which may be held from time
to
time by such stockholders and their donees, pledgees or successors .
Of the
shares of common stock offered under this prospectus, 9,411,948 shares were
issued in connection with a private placement of our shares to institutional
and
other accredited investors and 2,823,584 shares are issuable upon the exercise
of warrants issued to the investors in the private placement. We are not selling
any securities under this prospectus and will not receive any of the proceeds
from the sale of shares by the selling stockholders, although we may receive
proceeds upon the exercise of the warrants.
The
selling stockholders may sell the shares of common stock described in this
prospectus from time to time in a number of different ways and at varying prices
determined at the time of sale or at negotiated prices. We provide more
information about how the selling stockholders may sell their shares of common
stock in the section entitled “Plan of Distribution” on page 23 . We will not be
paying any underwriting discounts or commissions in this offering.
The
common stock is traded on the Nasdaq Global Market under the symbol “MITI.” On
November 21, 2008, the reported closing price of the common stock was $3.80
per
share.
An
investment in the shares offered hereby involves a high degree of risk. Before
investing in our common stock, we recommend that you carefully read this entire
prospectus, including the “Risk Factors” section beginning on page
4.
Neither
the Securities and Exchange Commission nor any state securities commission
has
approved or disapproved of these securities or passed upon the adequacy or
accuracy of this prospectus. Any representation to the contrary is a criminal
offense.
The
date of this prospectus is November 24, 2008.
TABLE
OF CONTENTS
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Page
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PROSPECTUS
SUMMARY
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1
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RISK
FACTORS
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4
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FORWARD-LOOKING
STATEMENTS
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18
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USE
OF PROCEEDS
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19
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SELLING
SECURITY HOLDERS
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19
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PLAN
OF DISTRIBUTION
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23
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LEGAL
MATTERS
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25
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EXPERTS
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25
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WHERE
YOU CAN FIND MORE INFORMATION
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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. The prospectus relates to 12,235,532 shares
of
our common stock, including 2,823,584 shares of our common stock issuable upon
the exercise of warrants, which the selling stockholders named in this
prospectus may sell from time to time. We will not receive any of the proceeds
from these sales, except that upon any exercise of the warrants by payment
of
cash, we will receive the exercise price of the warrants. We have agreed to
pay
the expenses incurred in registering these shares, including legal and
accounting fees.
You
should rely only on the information contained or incorporated by reference
in
this prospectus. We have not, and the selling stockholders have not, authorized
anyone to provide you with information different from that contained in this
prospectus. The selling stockholders are offering to sell, and seeking offers
to
buy, shares of our common stock only in jurisdictions where it is lawful to
do
so. The selling stockholders should not make an offer of these shares in any
state where the offer is not permitted. Brokers or dealers should confirm the
existence of an exemption from registration or effect a registration in
connection with any offer and sale of these shares.
The
information in this prospectus is accurate only as of the date of this
prospectus, regardless of the time of delivery of this prospectus or any sale
of
our common stock.
You
should read this prospectus together with the additional information described
under the heading “Where You Can Find More Information.”
PROSPECTUS
SUMMARY
This
summary highlights information contained elsewhere or incorporated by reference
into this prospectus. Because it is a summary, it does not contain all of the
information that you should consider before investing in our securities. You
should read this entire prospectus carefully, including the section entitled
“Risk Factors” and the documents that we incorporate by reference into this
prospectus, before making an investment decision.
MICROMET,
INC.
We
are a
biopharmaceutical company developing novel, proprietary antibodies for the
treatment of cancer, inflammation and autoimmune diseases. Four of our
antibodies are currently in clinical trials, while the remainder of our product
pipeline is in preclinical development. Blinatumomab, also known as MT103 and
MEDI-538, the most advanced antibody in our product pipeline developed using
our
BiTE ®
antibody
technology platform, is being evaluated in a phase 2 clinical trial for the
treatment of patients with acute lymphoblastic leukemia and in a phase 1
clinical trial for the treatment of patients with non-Hodgkin’s lymphoma. BiTE
antibodies represent a new class of antibodies that activate a patient’s own
cytotoxic T cells, considered the most powerful “killer cells” of the human
immune system, to eliminate cancer cells. We are developing blinatumomab in
collaboration with MedImmune, Inc., a subsidiary of AstraZeneca plc.
MT110, our second BiTE antibody in clinical development, is being evaluated
in a
phase 1 clinical trial for the treatment of patients with lung or
gastrointestinal cancer. Our third clinical stage antibody is adecatumumab,
also
known as MT201, a human monoclonal antibody that targets epithelial cell
adhesion molecule, or EpCAM-expressing solid tumors. We are developing
adecatumumab in collaboration with Merck Serono in a phase 1b clinical trial
evaluating adecatumumab in combination with docetaxel for the treatment of
patients with metastatic breast cancer. Our fourth clinical stage antibody
is
MT293, which is licensed to TRACON and is being developed in a phase 1 clinical
trial for the treatment of patients with cancer. We have additional BiTE
antibodies that are in different stages of preclinical development and that
target CEA, CD33, Her2, EGFR, and MCSP. In addition, we have established a
collaboration with Nycomed for the development and commercialization of MT203,
a
human antibody neutralizing the activity of granulocyte/macrophage colony
stimulating factor, or GM-CSF, which has potential applications in the treatment
of various inflammatory and autoimmune diseases, such as rheumatoid arthritis,
psoriasis, or multiple sclerosis. To date, we have incurred significant research
and development expenses and have not achieved any product revenues from sales
of our product candidates.
Each
of
our programs will require many years and significant costs to advance through
development. Typically it takes many years from the initial identification
of a
lead compound to the completion of preclinical and clinical trials, before
applying for marketing approval from the United States Food and Drug
Administration, or FDA, or European Medicines Agency, or EMEA, or equivalent
regulatory agencies. The risk that a program has to be terminated, in part
or in
full, for safety reasons or lack of adequate efficacy, is very high. In
particular, we cannot predict which, if any, of our potential product candidates
will be successfully developed or approved, nor can we predict the time and
cost
to complete development.
As
we
obtain results from preclinical studies or clinical trials, we may elect to
discontinue the development for certain product candidates for safety, efficacy
or commercial reasons. We may also elect to discontinue development of one
or
more product candidates in order to focus our resources on more promising
product candidates. Our business strategy includes entering into collaborative
agreements with third parties for the development and commercialization of
our
product candidates. Depending on the structure of such collaborative agreements,
a third party may be granted control over the clinical trial process for one
of
our product candidates. In such a situation, the third party, rather than us,
may in fact control development and commercialization decisions for the
respective product candidate. Consistent with our business model, we may enter
into additional collaboration agreements in the future. We cannot predict the
terms of such agreements or their potential impact on our capital requirements.
Our inability to complete our research and development projects in a timely
manner, or our failure to enter into new collaborative agreements, when
appropriate, could significantly increase our capital requirements and affect
our liquidity.
Since
our
inception, we have financed our operations through private placements of
preferred stock, debt financing, and government grants for research, as well
as licensing fees, milestone payments and research-contribution revenues
from our collaborations with pharmaceutical companies, and, more recently,
through private placements of common stock and associated warrants. We intend
to
continue to seek funding through public or private financings in the future.
If
we are successful in raising additional funds through the issuance of equity
securities, stockholders may experience substantial dilution including as a
result of issuing warrants in connection with the financing, or the equity
securities may have rights, preferences or privileges senior to existing
stockholders. If we are successful in raising additional funds through debt
financings, these financings may involve significant cash payment obligations
and covenants that restrict our ability to operate our business. There can
be no
assurance that we will be successful in raising additional capital on acceptable
terms, or at all.
As
described above, we have strategic collaborations with Merck Serono, MedImmune
and Nycomed to develop therapeutic antibodies in cancer and inflammatory and
autoimmune diseases. We also have a license agreement with TRACON for the
development and commercialization of one of our clinical stage product
candidates and an exclusive marketing agreement with Enzon, Inc. (now Enzon
Pharmaceuticals, Inc.) to market and license to third parties the companies’
respective single-chain antibody patent estates. See “Risk Factors” for a
discussion of risks relating to our business and owning our capital
stock.
On
May 5, 2006, CancerVax Corporation completed a merger with Micromet AG, a
privately-held German company. CancerVax was incorporated in the State of
Delaware on June 12, 1998. Following the merger, CancerVax was renamed
“Micromet, Inc.” Unless specifically noted otherwise, as used throughout this
prospectus, “Micromet”, “we,” “us,” and “our” refers to the business of the
combined company after the closing of the merger, and “collaborator” refers to
the counterparties to our collaboration agreements as well as the counterparties
to our license agreements.
Our
principal executive offices are located at 6707 Democracy Boulevard, Suite
505,
Bethesda, Maryland 20817, and our main telephone number is (240) 752-1420.
Our
website is located on the world wide web at http://www.micromet-inc.com.
We do
not incorporate by reference into this prospectus the information on, or
accessible through, our website, and you should not consider it as part of
this
prospectus.
RECENT
DEVELOPMENTS
We
entered into a Securities Purchase Agreement dated September 29, 2008 with
various institutional and individual accredited investors, pursuant to which
we
agreed to sell and issue an aggregate of 9,411,948 shares of our common stock,
which we refer to herein as the Shares, and Warrants to purchase up to an
aggregate of 2,823,584 shares of our common stock, which we refer to herein
as
the Warrant Shares, in a private placement. The per unit purchase price of
a
Share and a Warrant to purchase 0.3 shares of common stock was $4.25. The Shares
and the Warrants were issued on October 2, 2008. We received gross proceeds
of
approximately $40.0 million, before offering expenses. Among the investors
were
three of our directors in their individual capacities and two funds affiliated
with directors of our company. Piper Jaffray & Company acted as sole
book-running lead placement agent with respect to the transaction and received
an aggregate cash fee equal to approximately $1.7 million, and RBC Capital
Markets acted as co-lead placement agent and received an aggregate cash fee
equal to approximately $0.8 million.
The
Warrants are exercisable at $4.63 per share until October 2, 2013. The exercise
price of the Warrants is subject to adjustment upon certain transactions,
including stock splits, stock dividends, pro rata distributions of securities
or
assets to stockholders, mergers, consolidations, sales of all or substantially
all of our assets, tender or exchange offers or reclassifications.
In
connection with the private placement, we entered into a Registration Rights
Agreement dated September 29, 2008 pursuant to which we agreed to register
both
the Shares and the Warrant Shares for resale under the Securities Act of 1933,
as amended, or the Securities Act. Under the terms of the Registration Rights
Agreement, we were required to file a registration statement with the SEC on
or
before November 3, 2008. Pursuant to the Registration Rights Agreement, we
also
agreed to use commercially reasonable efforts to keep the Registration Statement
continuously effective under the Securities Act until the earlier of the date
on
which all of the Shares and Warrant Shares have been publicly sold by the
selling stockholders, or until October 2, 2010. We also agreed to other
customary obligations regarding registration, including matters relating to
indemnification and payment of expenses.
We
may be
liable for liquidated damages to holders of the Shares and Warrant Shares if
the
registration statement of which this prospectus is a part is not declared
effective by the earlier of January 30, 2009 or the tenth trading day following
the date on which we receive notification from the SEC that the registration
statement will not be reviewed or is no longer subject to further review by
the
SEC. We may also be liable for liquidated damages if the registration statement
ceases for any reason to remain continuously effective as to all of the Shares,
or a purchaser of the Shares is not permitted to resell such purchaser’s Shares
under the registration statement for any reason for more than an aggregate
of 20
consecutive calendar days or 40 total calendar days in any 12-month period,
or
if we fail to satisfy the current public information requirement under Rule
144(c)(1) of the Securities Act as a result of which the purchasers who are
not
affiliates are unable to sell their Shares. The amount of the liquidated damages
is, in aggregate, one percent per month, subject to an aggregate cap of six
percent, and in certain instances twelve percent, of the aggregate purchase
price of the securities, except that no liquidated damages will apply with
respect to the Warrants or the Warrant Shares prior to their
issuance.
THE
OFFERING
Issuer
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Micromet,
Inc.
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Selling
Stockholders
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Accredited
investors who purchased shares of our common stock and warrants in
a
private placement in October 2008.
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Securities offered by Selling Stockholders
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12,235,532
shares of our common stock, which includes 2,823,584 shares issuable
to
the selling stockholders named in this prospectus upon the exercise
of the
warrants.
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Use
of proceeds
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We
will not receive any proceeds from sales of the shares of common
stock
sold from time to time under this prospectus by the selling stockholders.
Upon any exercise of the warrants by payment of cash, however, we
will
receive the exercise price of the warrants, which will be used for
general
corporate purposes.
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Warrants
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Each
warrant is exercisable for shares of our common stock at an initial
exercise price of $4.63 per share, subject to adjustment upon certain
events. The warrants were exercisable upon issuance and will expire
at
5:30 p.m., New York City time, on October 2, 2013.
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Trading
of Warrants
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The
common stock underlying the warrants is being registered for resale
hereunder. Currently, there is no public market for the warrants,
and we
do not expect that any such market will develop. The warrants will
not be
listed on any securities exchange or included in any automated quotation
system.
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Risk
Factors
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An
investment in our common stock involves a high degree of risk. See
“Risk
Factors” beginning on page 4 for a discussion of certain factors that
you should consider when evaluating an investment in our common
stock.
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NASDAQ
Global Market symbol
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“MITI”
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RISK
FACTORS
Investing
in our common stock involves a high degree of risk. The following information
sets forth factors that could cause our actual results to differ materially
from
those contained in forward-looking statements we have made in this prospectus
and the information incorporated herein by reference and those we may make
from
time to time. If any of the following risks actually occur, the market price
of
our common stock could decline, and you could lose all or part of your
investment. Additional risks not presently known to us or that we currently
believe are immaterial may also significantly impair our business operations
and
could result in a complete loss of your investment.
Certain
factors individually or in combination with others may have a material adverse
effect on our business, financial condition and results of operations and you
should carefully consider them. You should also consider all other information
contained in or incorporated by reference in this prospectus before deciding
to
invest in our common stock.
Risks
Relating to Our Financial Results, Financial Reporting and Need for
Financing
We
have a history of losses, we expect to incur substantial losses and negative
operating cash flows for the foreseeable future and we may never achieve or
maintain profitability.
We
have
incurred losses from the inception of Micromet through September 30, 2008,
and
we expect to incur substantial losses for the foreseeable future. We have no
current sources of material ongoing revenue, other than the reimbursement of
development expenses and potential future milestone payments from our current
collaborators or licensees, Merck Serono, MedImmune, Nycomed and TRACON. We
have
not commercialized any products to date, either alone or with a third party
collaborator. If we are not able to commercialize any products, whether alone
or
with a collaborator, we may not achieve profitability. Even if our collaboration
agreements provide funding for a portion of our research and development
expenses for some of our programs, we expect to spend significant capital to
fund our internal research and development programs for the foreseeable future.
As a result, we will need to generate significant revenues in order to achieve
profitability. We cannot be certain whether or when this will occur because
of
the significant uncertainties that affect our business. Even if we do achieve
profitability, we may not be able to sustain or increase profitability on a
quarterly or annual basis. Our failure to become and remain profitable may
depress the market value of our common stock and could impair our ability to
raise capital, expand our business, diversify our product offerings or continue
our operations and, as a result, you could lose part or all of your
investment.
We
will require additional financing, which may be difficult to obtain and may
dilute your ownership interest in us. If we fail to obtain the capital necessary
to fund our operations, we will be unable to develop or commercialize our
product candidates and our ability to operate as a going concern may be
adversely affected.
We
will
require substantial funds to continue our research and development programs
and
our future capital requirements may vary from what we expect. There are factors,
many of which are outside our control, that may affect our future capital
requirements and accelerate our need for additional financing. Among the factors
that may affect our future capital requirements and accelerate our need for
additional financing are:
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continued
progress in our research and development programs, as well as the
scope of
these programs;
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our
ability to establish and maintain collaborative arrangements for
the
discovery, research or development of our product
candidates;
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the
timing, receipt and amount of research funding and milestone, license,
royalty and other payments, if any, from
collaborators;
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the
timing, receipt and amount of sales revenues and associated royalties
to
us, if any, from our product candidates in the
market;
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our
ability to sell shares of our common stock under our CEFF with
Kingsbridge;
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the
costs of preparing, filing, prosecuting, maintaining, defending and
enforcing patent claims and other patent-related costs, including
litigation costs and technology license
fees;
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costs
associated with
litigation; and
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competing
technological and market
developments.
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We
filed
a shelf registration statement, declared effective by the SEC on
December 9, 2004, under which we may raise up to $80 million through
the sale of our common stock. This shelf registration statement became inactive
in March 2006, and will expire in December 2008. We may seek to file a
new shelf registration statement, although our ability to do so will depend
on
our eligibility to use a shelf registration statement at such time, under
applicable SEC rules. We expect to seek additional funding through public or
private financings or from new collaborators with whom we enter into research
or
development collaborations with respect to programs that are not currently
licensed. However, the market for stock of companies in the biotechnology sector
in general, and the market for our common stock in particular, is highly
volatile. Due to market conditions and the status of our product development
pipeline, additional funding may not be available to us on acceptable terms,
or
at all. Having insufficient funds may require us to delay, scale back or
eliminate some or all of our research or development programs or to relinquish
greater or all rights to product candidates at an earlier stage of development
or on less favorable terms than we would otherwise choose. Failure to obtain
adequate financing also may adversely affect our ability to operate as a going
concern.
If
we
raise additional funds through the issuance of equity securities, our
stockholders may experience substantial dilution, including as a result of
the
issuance of warrants in connection with the financing, or the equity securities
may have rights, preferences or privileges senior to those of existing
stockholders. If we raise additional funds through debt financings, these
financings may involve significant cash payment obligations and covenants that
restrict our ability to operate our business and make distributions to our
stockholders. We also could elect to seek funds through arrangements with
collaborators or others that may require us to relinquish rights to certain
technologies, product candidates or products.
Our
committed equity financing facility with Kingsbridge may not be available to
us
if we elect to make a draw down, may require us to make additional “blackout” or
other payments to Kingsbridge and may result in dilution to our
stockholders.
In
August
2006, we entered into a CEFF with Kingsbridge. The CEFF entitles us to sell
and
obligates Kingsbridge to purchase, from time to time until September 2009,
shares of our common stock for cash consideration up to an aggregate of
$25 million, subject to certain conditions and restrictions. Kingsbridge
will not be obligated to purchase shares under the CEFF unless certain
conditions are met, which include:
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a
minimum price for our common stock that is not less than 85% of the
closing price of the day immediately preceding the applicable eight-day
pricing period, but in no event less than $2.00 per
share;
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the
accuracy of representations and warranties made to
Kingsbridge;
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our
compliance with all applicable laws which, if we failed to so comply,
would have a Material Adverse Effect (as that term is defined in
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purchase agreement with
Kingsbridge); and
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the
effectiveness of a registration statement registering for resale
the
shares of common stock to be issued in connection with the
CEFF.
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Kingsbridge
is permitted to terminate the CEFF by providing written notice to us upon the
occurrence of certain events. For example, we are only eligible to draw down
funds under the CEFF at such times as our stock price is above $2.00 per share.
Kingsbridge is also able to terminate the CEFF at any time that we have not
drawn down at least $1.25 million in funds over a consecutive 12-month period.
As of the date of this prospectus, we have not drawn down any funds from the
CEFF, and therefore Kingsbridge could terminate the CEFF under its terms. The
CEFF is scheduled to expire in September 2009. We intend to seek an extension
of
the term of the CEFF, but no assurance can be given that Kingsbridge will agree
to any such extension. In order to extend the term of the CEFF beyond September
2009, Kingsbridge may require additional consideration, such as the issuance
of
a warrant to purchase our common stock that could result in additional dilution
to our stockholders. If we are unable to access funds through the CEFF,
or if Kingsbridge terminates the CEFF or it otherwise expires, we may be
unable to access capital from other sources on favorable terms, or at
all.
We
are
entitled, in certain circumstances, to deliver a blackout notice to Kingsbridge
to suspend the use of the resale registration statement and prohibit Kingsbridge
from selling shares under the resale registration statement for a certain period
of time. If we deliver a blackout notice during the fifteen trading days
following our delivery of shares to Kingsbridge in connection with any draw
down, then we may be required to make a payment to Kingsbridge, or issue to
Kingsbridge additional shares in lieu of this payment, calculated on the basis
of the number of shares purchased by Kingsbridge in the most recent draw down
and held by Kingsbridge immediately prior to the blackout period and the decline
in the market price, if any, of our common stock during the blackout period.
If
the trading price of our common stock declines during a blackout period, this
blackout payment could be significant.
In
addition, if we fail to maintain the effectiveness of the resale registration
statement or related prospectus in circumstances not permitted by our agreement
with Kingsbridge, we may be required to make a payment to Kingsbridge,
calculated on the basis of the number of shares held by Kingsbridge during
the
period that the registration statement or prospectus is not effective,
multiplied by the decline in market price, if any, of our common stock during
the ineffective period. If the trading price of our common stock declines during
a period in which the resale registration statement or related prospectus is
not
effective, this payment could be significant.
Should
we
sell shares to Kingsbridge under the CEFF or issue shares in lieu of a blackout
payment, it will have a dilutive effect on the holdings of our current
stockholders and may result in downward pressure on the price of our common
stock. If we draw down under the CEFF, we will issue shares to Kingsbridge
at a
discount of 6% to 14% from the volume weighted average price of our common
stock. If we draw down amounts under the CEFF when our share price is
decreasing, we will need to issue more shares to raise the same amount than
if
our stock price was higher. Issuances in the face of a declining share price
will have an even greater dilutive effect than if our share price were stable
or
increasing and may further decrease our share price. Moreover, the number of
shares that we will be able to issue to Kingsbridge in a particular draw down
may be materially reduced if our stock price declines significantly during
the
applicable eight-day pricing period.
Our
quarterly operating results and stock price may fluctuate
significantly.
We
expect
our results of operations to be subject to quarterly fluctuations. The level
of
our revenues, if any, and results of operations for any given period, will
be
based primarily on the following factors:
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the
status of development of our product
candidates;
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the
time at which we enter into research and license agreements with
strategic
collaborators that provide for payments to us, and the timing and
accounting treatment of payments to us, if any, under those
agreements;
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whether
or not we achieve specified research, development or commercialization
milestones under any agreement that we enter into with strategic
collaborators and the timely payment by these collaborators of any
amounts
payable to us;
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the
addition or termination of research programs or funding support under
collaboration agreements;
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the
timing of milestone payments under license agreements, repayments
of
outstanding amounts under loan agreements, and other payments that
we may
be required to make to others;
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variations
in the level of research and development expenses related to our
clinical
or preclinical product candidates during any given
period;
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the
change in fair value of the common stock warrants issued to investors
in
connection with our 2007 private placement financing, remeasured
at each
balance sheet date using a Black-Scholes option-pricing model, with
the
change in value recorded as other income or expense;
and
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general
market conditions affecting companies with our risk profile and market
capitalization.
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These
factors may cause the price of our stock to fluctuate substantially. We believe
that quarterly comparisons of our financial results are not necessarily
meaningful and should not be relied upon as an indication of our future
performance.
If
the estimates we make and the assumptions on which we rely in preparing our
financial statements prove inaccurate, our actual results may vary
significantly.
Our
financial statements have been prepared in accordance with generally accepted
accounting principles in the United States. The preparation of these financial
statements requires us to make estimates and judgments that affect the reported
amounts of our assets, liabilities, revenues and expenses, the amounts of
charges taken by us and related disclosure. We base our estimates on historical
experience and on various other assumptions that we believe to be reasonable
under the circumstances. We cannot assure you that our estimates, or the
assumptions underlying them, will be correct. Accordingly, our actual financial
results may vary significantly from the estimates contained in our financial
statements.
Changes
in, or interpretations of, accounting rules and regulations could result in
unfavorable accounting charges or require us to change our compensation
policies.
Accounting
methods and policies for biopharmaceutical companies, including policies
governing revenue recognition, research and development and related expenses,
accounting for stock options and in-process research and development costs
are
subject periodically to further review, interpretation and guidance from
relevant accounting authorities, including the SEC. Changes to, or
interpretations of, accounting methods or policies in the future may require
us
to reclassify, restate or otherwise change or revise our financial statements,
including those contained in this filing.
Our
operating and financial flexibility, including our ability to borrow money,
is
limited by certain debt arrangements.
Our
loan
agreements contain certain customary events of default, which generally include,
among others, non-payment of principal and interest, violation of covenants,
cross defaults, the occurrence of a material adverse change in our ability
to
satisfy our obligations under our loan agreements or with respect to one of
our
lenders’ security interest in our assets and in the event we are involved in
certain insolvency proceedings. Upon the occurrence of an event of default,
our
lenders may be entitled to, among other things, accelerate all of our
obligations and sell our assets to satisfy our obligations under our loan
agreements. In addition, in an event of default, our outstanding obligations
may
be subject to increased rates of interest.
In
addition, we may incur additional indebtedness from time to time to finance
acquisitions, investments or strategic alliances or capital expenditures or
for
other purposes. Our level of indebtedness could have negative consequences
for
us, including the following:
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our
ability to obtain additional financing, if necessary, for working
capital,
capital expenditures, acquisitions or other purposes may be impaired
or
such financing may not be available on favorable
terms;
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payments
on our indebtedness will reduce the funds that would otherwise be
available for our operations and future business
opportunities;
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we
may be more highly leveraged than our competitors, which may place
us at a
competitive disadvantage; and
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our
debt level may reduce our flexibility in responding to changing business
and economic conditions.
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We
have determined and further received an opinion from our independent registered
public accounting firm in connection with our year-end audit for 2007 that
our
system of internal control over financial reporting does not meet the
requirements of Section 404 of the Sarbanes-Oxley Act of 2002. As a result,
investors could lose confidence in the reliability of our internal control
over
financial reporting, which could have a material adverse effect on our stock
price.
As
a
publicly traded company, we are required to comply with the Sarbanes-Oxley
Act
of 2002, or Sarbanes-Oxley, and the related rules and regulations of the SEC,
including Section 404 of Sarbanes-Oxley. We are in the process of upgrading
our existing, and implementing additional, procedures and controls.
Our
internal control system is designed to provide reasonable assurance to our
management and board of directors regarding the preparation and fair
presentation of published financial statements. In connection with the audit
of
our consolidated financial statements for the year ended December 31, 2007,
our independent registered public accounting firm provided us with an
unqualified opinion on our consolidated financial statements, but it identified
material weaknesses in our internal control over financial reporting based
on
criteria established in “Internal Control — Integrated Framework,” issued
by the Committee of Sponsoring Organizations, or COSO, of the Treadway
Commission. These material weaknesses relate to certain of our accrual processes
and an insufficient level of management review in our financial statement close
and reporting process. Because of these material weaknesses in our internal
control over financial reporting, there is heightened risk that a material
misstatement of our annual or quarterly financial statements will not be
prevented or detected.
We
are in
the process of expanding our internal resources and implementing additional
procedures in order to remediate these material weaknesses in our internal
control over financial reporting; however, we cannot guarantee that these
efforts will be successful. If we do not adequately remedy these material
weaknesses, and if we fail to maintain proper and effective internal control
over financial reporting in future periods, our ability to provide timely and
reliable financial results could suffer, and investors could lose confidence
in
our reported financial information, which may have a material adverse effect
on
our stock price.
Risks
Relating to Our Common Stock
Substantial
sales of shares may adversely impact the market price of our common stock and
our ability to issue and sell shares in the future.
Substantially
all of the outstanding shares of our common stock are eligible for resale in
the
public market. A significant portion of these shares is held by a small number
of stockholders. We have also registered shares of our common stock that we
may
issue under our equity incentive compensation plans and our employee stock
purchase plan. In addition, any shares issued under the CEFF would be covered
by
a registration statement and eligible for resale in the public market. These
shares generally can be freely sold in the public market upon issuance. If
our
stockholders sell substantial amounts of our common stock, the market price
of
our common stock may decline, which might make it more difficult for us to
sell
equity or equity-related securities in the future at a time and price that
we
deem appropriate. We are unable to predict the effect that sales of our common
stock may have on the prevailing market price of our common stock.
Our
stock price may be volatile, and you may lose all or a substantial part of
your
investment.
The
market price for our common stock is volatile and may fluctuate significantly
in
response to a number of factors, a number of which we cannot control. Among
the
factors that could cause material fluctuations in the market price for our
common stock are:
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our
ability to upgrade and implement our disclosure controls and our
internal
control over financial reporting;
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our
ability to successfully raise capital to fund our continued
operations;
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our
ability to successfully develop our product candidates within acceptable
timeframes;
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changes
in the regulatory status of our product
candidates;
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changes
in significant contracts, strategic collaborations, new technologies,
acquisitions, commercial relationships, joint ventures or capital
commitments;
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the
execution of new collaboration agreements or termination of existing
collaborations related to our clinical or preclinical product candidates
or our BiTE antibody technology
platform;
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announcements
of the invalidity of, or litigation relating to, our key intellectual
property;
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announcements
of the achievement of milestones in our agreements with collaborators
or
the receipt of payments under those
agreements;
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announcements
of the results of clinical trials by us or by companies with commercial
products or product candidates in the same therapeutic category as
our
product candidates;
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events
affecting our collaborators;
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fluctuations
in stock market prices and trading volumes of similar
companies;
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announcements
of new products or technologies, clinical trial results, commercial
relationships or other events by us, our collaborators or our
competitors;
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our
ability to successfully complete strategic collaboration arrangements
with
respect to our product candidates;
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variations
in our quarterly operating results;
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changes
in securities analysts’ estimates of our financial performance or product
development timelines;
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changes
in accounting principles;
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sales
of large blocks of our common stock, including sales by our executive
officers, directors and significant
stockholders;
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additions
or departures of key
personnel; and
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discussions
of Micromet or our stock price by the financial and scientific press
and
online investor communities such as chat
rooms.
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If
our officers and directors choose to act together, they can significantly
influence our management and operations in a manner that may be in their best
interests and not in the best interests of other
stockholders.
Our
officers and directors, together with their affiliates, collectively own an
aggregate of approximately 24% of our outstanding common stock. As a result,
if
they act together, they may significantly influence all matters requiring
approval by our stockholders, including the election of directors and the
approval of mergers or other business combination transactions. The interests
of
this group of stockholders may not always coincide with our interests or the
interests of other stockholders, and this group may act in a manner that
advances their best interests and not necessarily those of other
stockholders.
Our
stockholder rights plan, anti-takeover provisions in our organizational
documents and Delaware law may discourage or prevent a change in control, even
if an acquisition would be beneficial to our stockholders, which could affect
our stock price adversely and prevent attempts by our stockholders to replace
or
remove our current management.
Our
stockholder rights plan and provisions contained in our amended and restated
certificate of incorporation and amended and restated bylaws may delay or
prevent a change in control, discourage bids at a premium over the market price
of our common stock and adversely affect the market price of our common stock
and the voting and other rights of the holders of our common stock. The
provisions in our amended and restated certificate of incorporation and amended
and restated bylaws include:
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dividing
our board of directors into three classes serving staggered three-year
terms;
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prohibiting
our stockholders from calling a special meeting of
stockholders;
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permitting
the issuance of additional shares of our common stock or preferred
stock
without stockholder approval;
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prohibiting
our stockholders from making certain changes to our amended and restated
certificate of incorporation or amended and restated bylaws except
with 66
2/3% stockholder approval; and
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requiring
advance notice for raising matters of business or making nominations
at
stockholders’ meetings.
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We
are
also subject to provisions of the Delaware corporation law that, in general,
prohibit any business combination with a beneficial owner of 15% or more of
our
common stock for five years unless the holder’s acquisition of our stock was
approved in advance by our board of directors.
We
may become involved in securities class action litigation that could divert
management’s attention and harm our business and our insurance coverage may not
be sufficient to cover all costs and damages.
The
stock
market has from time to time experienced significant price and volume
fluctuations that have affected the market prices for the common stock of
pharmaceutical and biotechnology companies. These broad market fluctuations
may
cause the market price of our common stock to decline. In the past, following
periods of volatility in the market price of a particular company’s securities,
securities class action litigation has often been brought against that company.
We may become involved in this type of litigation in the future. Litigation
often is expensive and diverts management’s attention and resources, which could
adversely affect our business.
Risks
Relating to Our Collaborations and Clinical Programs
We
are dependent on collaborators for the development and commercialization of
many
of our product candidates. If we lose any of these collaborators, or if they
fail or incur delays in the development or commercialization of our current
and
future product candidates, our operating results would
suffer.
The
success of our strategy for development and commercialization of our product
candidates depends upon our ability to form and maintain productive strategic
collaborations and license arrangements. We currently have strategic
collaborations or license arrangements with Merck Serono, MedImmune, Nycomed
and
TRACON. We expect to enter into additional collaborations and license
arrangements in the future. Our existing and any future collaborations and
licensed programs may not be scientifically or commercially successful. The
risks that we face in connection with these collaborations and licensed programs
include the following:
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Each
of our collaborators has significant discretion in determining the
efforts
and resources that it will apply to the collaboration. The timing
and
amount of any future royalty and milestone revenue that we may receive
under such collaborative and licensing arrangements will depend on,
among
other things, such collaborator’s efforts and allocation of
resources.
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All
of our strategic collaboration and license agreements are for fixed
terms
and are subject to termination under various circumstances, including,
in
some cases, on short notice without cause. If any of our collaborative
partners were to terminate its agreement with us, we may attempt
to
identify and enter into an agreement with a new collaborator with
respect
to the product candidate covered by the terminated agreement. If
we are
not able to do so, we may not have the funds or capability to undertake
the development, manufacturing and commercialization of that product
candidate, which could result in a discontinuation or delay of the
development of that product
candidate.
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Our
collaborators may develop and commercialize, either alone or with
others,
products and services that are similar to or competitive with the
product
candidates and services that are the subject of their collaborations
with
us or programs licensed from us.
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Our
collaborators may discontinue the development of our product candidates
in
specific indications, for example as a result of their assessment
of the
results obtained in clinical trials, or fail to initiate the development
in indications that have a significant commercial
potential.
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Pharmaceutical
and biotechnology companies from time to time re-evaluate their research
and development priorities, including in connection with mergers
and
consolidations, which have been common in recent years. The ability
of our
product candidates involved in strategic collaborations to reach
their
potential could be limited if, as a result of such changes, our
collaborators decrease or fail to increase spending related to such
product candidates, or decide to discontinue the development of our
product candidates and terminate their collaboration or license agreement
with us. In the event of such a termination, we may not be able to
identify and enter into a collaboration agreement for our product
candidates with another pharmaceutical or biotechnology company on
terms favorable to us or at all, and we may not have sufficient financial
resources to continue the development program for these product candidates
on our own. As a result, we may incur delays in the development for
these
product candidates following any potential termination of the
collaboration agreement, or we may need to reallocate financial resources
that may cause delays in other development programs for our other
product
candidates.
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We
may not be successful in establishing additional strategic collaborations,
which
could adversely affect our ability to develop and commercialize product
candidates.
As
an
integral part of our ongoing research and development efforts, we periodically
review opportunities to establish new collaborations for development and
commercialization of new BiTE antibodies or existing product candidates in
our
development pipeline. We face significant competition in seeking appropriate
collaborators and the negotiation process is time-consuming and complex. We
may
not be successful in our efforts to establish additional collaborations or
other
alternative arrangements. Even if we are successful in our efforts to establish
a collaboration, the terms of the agreement may not be favorable to us. Finally,
such collaborations or other arrangements may not result in successful products
and associated revenue from milestone payments, royalties or profit share
payments.
If
the combination of adecatumumab (MT201) with cytotoxics, such as docetaxel,
is
not tolerable or safe, if higher serum levels of adecatumumab cannot be
administered safely, or if sufficient anti-tumor activity cannot be shown,
we
and our collaborator Merck Serono may decide to abandon all or part of the
development program, and we could experience a material adverse impact on our
business prospects.
We
previously have reported that the phase 2 clinical trials of adecatumumab
did not reach their respective primary endpoint in patients with metastatic
breast cancer (clinical benefit rate at week 24) and in patients with
prostate cancer (mean change in prostate specific antigen, compared to placebo
control). We have also reported that we are continuing the development of
adecatumumab in a clinical trial in combination with docetaxel with escalating
doses of adecatumumab to investigate the tolerability and the safety of this
combination. If the combination of adecatumumab with docetaxel proves not to
be
tolerable or safe or if no higher serum levels of adecatumumab compared to
previous clinical trials can be administered safely or if sufficient anti-tumor
activity cannot be shown in this or future clinical trials, we and our
collaborator Merck Serono may decide to abandon all or part of the development
program of adecatumumab and as a result we may experience a material adverse
impact on our business prospects.
There
can be no assurance that our current continuous infusion phase 1 clinical
trial of blinatumomab (MT103) will establish a dose that is safe and
tolerable.
We
are
conducting a phase 1 dose finding clinical trial designed to evaluate the
safety and tolerability of a continuous intravenous infusion of
blinatumomab over 4-8 weeks at different dose levels in patients with
relapsed non-Hodgkin’s lymphoma. We have seen objective tumor responses at the
15 µg/m 2
and
above per day dose level with the continuous infusion regimens. While this
preliminary data suggest that blinatumomab has anti-tumor activity, there can
be
no assurance that we will not encounter unacceptable adverse events during
the
continued dose escalation of our ongoing, continuous-infusion phase 1
clinical trial or that the preliminary suggestion of anti-tumor activity will
be
confirmed during the ongoing or any future study.
Risks
Relating to Our Operations, Business Strategy, and the Life Sciences
Industry
We
face substantial competition, which may result in our competitors discovering,
developing or commercializing products before or more successfully than we
do.
Our
product candidates face competition with existing and new products being
developed by biotechnology and pharmaceutical companies, as well as universities
and other research institutions. For example, research in the fields of
antibody-based therapeutics for the treatment of cancer, and autoimmune and
inflammatory diseases, is highly competitive. A number of entities are seeking
to identify and patent antibodies, potentially active proteins and other
potentially active compounds without specific knowledge of their therapeutic
functions. Our competitors may discover, characterize and develop important
inducing molecules or genes in advance of us.
Many
of
our competitors have substantially greater capital resources, research and
development staffs and facilities than we have. Efforts by other biotechnology
and pharmaceutical companies could render our programs or product candidates
uneconomical or result in therapies that are superior to those that we are
developing alone or with a collaborator. We and our collaborators face
competition from companies that may be more experienced in product development
and commercialization, obtaining regulatory approvals and product manufacturing.
As a result, they may develop competing products more rapidly that are safer,
more effective, or have fewer side effects, or are less expensive, or they
may
discover, develop and commercialize products, which render our product
candidates non-competitive or obsolete. We expect competition to intensify
in
antibody research as technical advances in the field are made and become more
widely known.
We
may not be successful in our efforts to expand our portfolio of product
candidates.
A
key
element of our strategy is to discover, develop and commercialize a portfolio
of
new antibody therapeutics. We are seeking to do so through our internal research
programs and in-licensing activities, which could place a strain on our human
and capital resources. A significant portion of the research that we are
conducting involves new and unproven technologies. Research programs to identify
new disease targets and product candidates require substantial technical,
financial and human resources regardless of whether or not any suitable
candidates are ultimately identified. Our research programs may initially show
promise in identifying potential product candidates, yet fail to yield product
candidates suitable for clinical development. If we are unable to discover
suitable potential product candidates, develop additional delivery technologies
through internal research programs or in-license suitable product candidates
or
delivery technologies on acceptable business terms, our business prospects
will
suffer.
The
product candidates in our pipeline are in early stages of development and our
efforts to develop and commercialize these product candidates are subject to
a
high risk of delay and failure. If we fail to successfully develop our product
candidates, our ability to generate revenues will be substantially
impaired.
The
process of successfully developing product candidates for the treatment of
human
diseases is very time-consuming, expensive and unpredictable and there is a
high
rate of failure for product candidates in preclinical development and in
clinical trials. The preclinical studies and clinical trials may produce
negative, inconsistent or inconclusive results, and the results from early
clinical trials may not be statistically significant or predictive of results
that will be obtained from expanded, advanced clinical trials. Further, we
or
our collaborators may decide, or the FDA, EMEA or other regulatory authorities
may require us, to conduct preclinical studies or clinical trials or other
development activities in addition to those performed or planned by us or our
collaborators, which may be expensive or could delay the time to market for
our
product candidates. In addition, we do not know whether the clinical trials
will
result in marketable products.
All
of
our product candidates are in early stages of clinical and preclinical
development, so we will require substantial additional financial resources,
as
well as research, product development and clinical development capabilities,
to
pursue the development of these product candidates, and we may never develop
an
approvable or commercially viable product.
We
do not
know whether our planned preclinical development or clinical trials for our
product candidates will begin on time or be completed on schedule, if at all.
The timing and completion of clinical trials of our product candidates depend
on, among other factors, the number of patients that will be required to enroll
in the clinical trials, the inclusion and exclusion criteria used for selecting
patients for a particular clinical trial, and the rate at which those patients
are enrolled. Any increase in the required number of patients, tightening of
selection criteria, or decrease in recruitment rates or difficulties retaining
study participants may result in increased costs, delays in the development
of
the product candidate, or both.
Because
our product candidates may have different efficacy profiles in certain clinical
indications, sub-indications or patient profiles, an election by us or our
collaborators to focus on a particular indication, sub-indication or patient
profile may result in a failure to capitalize on other potentially profitable
applications of our product candidates.
Our
product candidates may not be effective in treating any of our targeted diseases
or may prove to have undesirable or unintended side effects, toxicities or
other
characteristics that may prevent or limit their commercial use. Institutional
review boards or regulators, including the FDA and EMEA, may hold, suspend
or
terminate our clinical research or the clinical trials of our product candidates
for various reasons, including non-compliance with regulatory requirements
or
if, in their opinion, the participating subjects are being exposed to
unacceptable health risks, or if additional information may be required for
the
regulatory authority to assess the proposed development activities. Further,
regulators may not approve study protocols at all or in a timeframe anticipated
by us if they believe that the study design or the mechanism of action of our
product candidates poses an unacceptable health risk to study
participants.
We
have
limited financial and managerial resources. These limitations require us to
focus on a select group of product candidates in specific therapeutic areas
and
to forego the exploration of other product opportunities. While our technologies
may permit us to work in multiple areas, resource commitments may require
trade-offs resulting in delays in the development of certain programs or
research areas, which may place us at a competitive disadvantage. Our decisions
as to resource allocation may not lead to the development of viable commercial
products and may divert resources away from other market opportunities, which
would otherwise have ultimately proved to be more profitable.
We
rely heavily on third parties for the conduct of preclinical studies and
clinical trials of our product candidates, and we may not be able to control
the
proper performance of the studies or trials.
In
order
to obtain regulatory approval for the commercial sale of our product candidates,
we and our collaborators are required to complete extensive preclinical studies
as well as clinical trials in humans to demonstrate to the FDA, EMEA and other
regulatory authorities that our product candidates are safe and effective.
We
have limited experience and internal resources for conducting certain
preclinical studies and clinical trials and rely primarily on collaborators
and
contract research organizations for the performance and management of certain
preclinical studies and clinical trials of our product candidates. We are
responsible for confirming that our preclinical studies are conducted in
accordance with applicable regulations and that each of our clinical trials
is
conducted in accordance with its general investigational plan and protocol.
Our
reliance on third parties does not relieve us of responsibility for ensuring
compliance with appropriate regulations and standards for conducting,
monitoring, recording and reporting of preclinical and clinical trials. If
our
collaborators or contractors fail to properly perform their contractual or
regulatory obligations with respect to conducting or overseeing the performance
of our preclinical studies or clinical trials, do not meet expected deadlines,
fail to comply with the good laboratory practice guidelines or good clinical
practice regulations, do not adhere to our preclinical and clinical trial
protocols, suffer an unforeseen business interruption unrelated to our agreement
with them that delays the clinical trial, or otherwise fail to generate reliable
clinical data, then the completion of these studies or trials may be delayed,
the results may not be useable and the studies or trials may have to be repeated
, and we may need to enter into new arrangements with alternative third
parties. Any of these events could cause our clinical trials to be extended,
delayed, or terminated or create the need for them to be repeated, or otherwise
create additional costs in the development of our product candidates and could
adversely affect our and our collaborators’ ability to market a product after
marketing approvals have been obtained.
Even
if we complete the lengthy, complex and expensive development process, there
is
no assurance that we or our collaborators will obtain the regulatory approvals
necessary for the launch and commercialization of our product
candidates.
To
the
extent that we or our collaborators are able to successfully complete the
clinical development of a product candidate, we or our collaborators will be
required to obtain approval by the FDA, EMEA or other regulatory authorities
prior to marketing and selling such product candidate in the United States,
the
European Union or other countries.
The
process of preparing and filing applications for regulatory approvals with
the
FDA, EMEA and other regulatory authorities, and of obtaining the required
regulatory approvals from these regulatory authorities is lengthy and expensive,
and may require two years or more. This process is further complicated because
some of our product candidates use non-traditional or novel materials in
non-traditional or novel ways, and the regulatory officials have little
precedent to follow.
Any
marketing approval by the FDA, EMEA or other regulatory authorities may be
subject to limitations on the indicated uses for which we or our collaborators
may market the product candidate. These limitations could restrict the size
of
the market for the product and affect reimbursement levels by third-party
payers.
As
a
result of these factors, we or our collaborators may not successfully begin
or
complete clinical trials and launch and commercialize any product candidates
in
the time periods estimated, if at all. Moreover, if we or our collaborators
incur costs and delays in development programs or fail to successfully develop
and commercialize products based upon our technologies, we may not become
profitable and our stock price could decline.
We
and our collaborators are subject to governmental regulations other than those
imposed by the FDA and EMEA, and we or our collaborators may not be able to
comply with these regulations. Any non-compliance could subject us or our
collaborators to penalties and otherwise result in the limitation of our or
our
collaborators’ operations.
In
addition to regulations imposed by the FDA, EMEA and other health regulatory
authorities, we and our collaborators are subject to regulation under the
Occupational Safety and Health Act, the Environmental Protection Act, the Toxic
Substances Control Act, the Research Conservation and Recovery Act, as well
as
regulations administered by the Nuclear Regulatory Commission, national
restrictions on technology transfer, import, export and customs regulations
and
certain other local, state or federal regulations, or their counterparts in
Europe and other countries. From time to time, other governmental agencies
and
legislative or international governmental bodies have indicated an interest
in
implementing further regulation of biotechnology applications. We are not able
to predict whether any such regulations will be adopted or whether, if adopted,
such regulations will apply to our or our collaborators’ business, or whether we
or our collaborators would be able to comply, without incurring unreasonable
expense, or at all, with any applicable regulations.
Our
growth could be limited if we are unable to attract and retain key personnel
and
consultants.
We
have
limited experience in filing and prosecuting regulatory applications to obtain
marketing approval from the FDA, EMEA or other regulatory authorities. Our
success depends on the ability to attract, train and retain qualified scientific
and technical personnel, including consultants, to further our research and
development efforts. The loss of services of one or more of our key employees
or
consultants could have a negative impact on our business and operating results.
Competition for skilled personnel is intense and the turnover rate can be high.
Competition for experienced management and clinical, scientific and engineering
personnel from numerous companies and academic and other research institutions
may limit our ability to attract and retain qualified personnel on acceptable
terms. As a result, locating candidates with the appropriate qualifications
can
be difficult, and we may not be able to attract and retain sufficient numbers
of
highly skilled employees.
Any
growth and expansion into areas and activities that may require additional
personnel or expertise, such as in regulatory affairs, quality assurance, and
control and compliance, would require us to either hire new key personnel or
obtain such services from a third party. The pool of personnel with the skills
that we require is limited, and we may not be able to hire or contract such
additional personnel. Failure to attract and retain personnel would prevent
us
from developing and commercializing our product candidates.
If
our third-party manufacturers do not follow current good manufacturing practices
or do not maintain their facilities in accordance with these practices, our
product development and commercialization efforts may be
harmed.
We
have
no manufacturing experience or manufacturing capabilities for the production
of
our product candidates for clinical trials or commercial sale. Product
candidates used in clinical trials or sold after marketing approval has been
obtained must be manufactured in accordance with current good manufacturing
practices regulations. There are a limited number of manufacturers that operate
under these regulations, including the FDA’s and EMEA’s good manufacturing
practices regulations, and that are capable of manufacturing our product
candidates. Third-party manufacturers may encounter difficulties in achieving
quality control and quality assurance and may experience shortages of qualified
personnel. Also, manufacturing facilities are subject to ongoing periodic,
unannounced inspection by the FDA, the EMEA, and other regulatory agencies
or
authorities, to ensure strict compliance with current good manufacturing
practices and other governmental regulations and standards. A failure of
third-party manufacturers to follow current good manufacturing practices or
other regulatory requirements and to document their adherence to such practices
may lead to significant delays in the availability of product candidates for
use
in a clinical trial or for commercial sale, the termination of, or hold on
a
clinical trial, or may delay or prevent filing or approval of marketing
applications for our product candidates. In addition, as a result of such a
failure, we could be subject to sanctions, including fines, injunctions and
civil penalties, refusal or delays by regulatory authorities to grant marketing
approval of our product candidates, suspension or withdrawal of marketing
approvals, seizures or recalls of product candidates, operating restrictions
and
criminal prosecutions, any of which could significantly and adversely affect
our
business. If we were required to change manufacturers, it may require additional
clinical trials and the revalidation of the manufacturing process and procedures
in accordance with applicable current good manufacturing practices and may
require FDA or EMEA approval. This revalidation may be costly and
time-consuming. If we are unable to arrange for third-party manufacturing of
our
product candidates, or to do so on commercially reasonable terms, we may not
be
able to complete development or marketing of our product
candidates.
Even
if regulatory authorities approve our product candidates, we may fail to comply
with ongoing regulatory requirements or experience unanticipated problems with
our product candidates, and these product candidates could be subject to
restrictions or withdrawal from the market following
approval.
Any
product candidates for which we obtain marketing approval, along with the
manufacturing processes, post-approval clinical trials and promotional
activities for such product candidates, will be subject to continual review
and
periodic inspections by the FDA, EMEA and other regulatory authorities. Even
if
regulatory approval of a product candidate is granted, the approval may be
subject to limitations on the indicated uses for which the product may be
marketed or contain requirements for costly post-marketing testing and
surveillance to monitor the safety or efficacy of the product. Post-approval
discovery of previously unknown problems with any approved products, including
unanticipated adverse events or adverse events of unanticipated severity or
frequency, difficulties with a manufacturer or manufacturing processes, or
failure to comply with regulatory requirements, may result in restrictions
on
such approved products or manufacturing processes, limitations in the scope
of
our approved labeling, withdrawal of the approved products from the market,
voluntary or mandatory recall and associated publicity requirements, fines,
suspension or withdrawal of regulatory approvals, product seizures, injunctions
or the imposition of civil or criminal penalties.
The
procedures and requirements for granting marketing approvals vary among
countries, which may cause us to incur additional costs or delays or may prevent
us from obtaining marketing approvals in different countries and regulatory
jurisdictions.
We
intend
to market our product candidates in many countries and regulatory jurisdictions.
In order to market our product candidates in the United States, the European
Union and many other jurisdictions, we must obtain separate regulatory approvals
in each of these countries and territories. The procedures and requirements
for
obtaining marketing approval vary among countries and regulatory jurisdictions,
and can involve additional clinical trials or other tests. Also, the time
required to obtain approval may differ from that required to obtain FDA and
EMEA
approval. The various regulatory approval processes may include all of the
risks
associated with obtaining FDA and EMEA approval. We may not obtain all of the
desirable or necessary regulatory approvals on a timely basis, if at all.
Approval by a regulatory authority in a particular country or regulatory
jurisdiction, such as the FDA in the United States and the EMEA in the European
Union, generally does not ensure approval by a regulatory authority in another
country. We may not be able to file for regulatory approvals and may not receive
necessary approvals to commercialize our product candidates in any or all of
the
countries or regulatory jurisdictions in which we desire to market our product
candidates.
If
we fail to obtain an adequate level of reimbursement for any approved products
by third-party payers, there may be no commercially viable markets for these
products or the markets may be much smaller than expected. The continuing
efforts of the government, insurance companies, managed care organizations
and
other payers of health care costs to contain or reduce costs of healthcare
may
adversely affect our ability to generate revenues and achieve profitability,
the
future revenues and profitability of our potential customers, suppliers and
collaborators, and the availability of capital.
Our
ability to commercialize our product candidates successfully will depend in
part
on the extent to which governmental authorities, private health insurers and
other organizations establish appropriate reimbursement levels for the price
charged for our product candidates and related treatments. The efficacy, safety
and cost-effectiveness of our product candidates as well as the efficacy, safety
and cost-effectiveness of any competing products will determine in part the
availability and level of reimbursement. These third-party payors continually
attempt to contain or reduce the costs of healthcare by challenging the prices
charged for healthcare products and services. Given recent federal and state
government initiatives directed at lowering the total cost of healthcare in
the
United States, the U.S. Congress and state legislatures will likely
continue to focus on healthcare reform, the cost of prescription pharmaceuticals
and on the reform of the Medicare and Medicaid systems. In certain countries,
particularly the countries of the European Union, the pricing of prescription
pharmaceuticals is subject to governmental control. In these countries, pricing
negotiations with governmental authorities can take six to twelve months or
longer after the receipt of regulatory marketing approval for a product. To
obtain reimbursement or pricing approval in some countries, we may be required
to conduct clinical trials that compare the cost-effectiveness of our product
candidates to other available therapies. If reimbursement for our product
candidates were unavailable or limited in scope or amount or if reimbursement
levels or prices are set at unsatisfactory levels, our projected and actual
revenues and our prospects for profitability would be negatively
affected.
Another
development that may affect the pricing of drugs in the United States is
regulatory action regarding drug reimportation into the United States. The
Medicare Prescription Drug, Improvement and Modernization Act, requires the
Secretary of the U.S. Department of Health and Human Services to promulgate
regulations allowing drug reimportation from Canada into the United States
under
certain circumstances. These provisions will become effective only if the
Secretary certifies that such imports will pose no additional risk to the
public’s health and safety and result in significant cost savings to consumers.
Proponents of drug reimportation may also attempt to pass legislation that
would
remove the requirement for the Secretary’s certification or allow reimportation
under circumstances beyond those anticipated under current law. If legislation
is enacted, or regulations issued, allowing the reimportation of drugs, it
could
decrease the reimbursement we would receive for any product candidates that
we
may commercialize, or require us to lower the price of our product candidates
then on the market that face competition from lower-priced supplies of that
product from other countries. These factors would negatively affect our
projected and actual revenues and our prospects for profitability.
We
are
unable to predict what additional legislation or regulation, if any, relating
to
the healthcare industry or third-party coverage and reimbursement may be enacted
in the future or what effect such legislation or regulation would have on our
business. Any cost containment measures or other healthcare system reforms
that
are adopted could have a material adverse effect on our ability to commercialize
successfully any future products or could limit or eliminate our spending on
development projects and affect our ultimate profitability.
If
physicians and patients do not accept the product candidates that we may
develop, our ability to generate product revenue in the future will be adversely
affected.
Our
product candidates, if successfully developed and approved by the regulatory
authorities, may not gain market acceptance among physicians, healthcare payers,
patients and the medical community. Market acceptance of and demand for any
product candidate that we may develop will depend on many factors,
including:
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ability
to provide acceptable evidence of safety and efficacy;
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convenience
and ease of administration;
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prevalence
and severity of adverse side effects;
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the
timing and market entry relative to competitive
treatments;
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cost
effectiveness;
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effectiveness
of our marketing and pricing strategy for any product candidates
that we
may develop;
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publicity
concerning our product candidates or competitive
products;
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the
strength of distribution support; and
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our
ability to obtain third-party coverage or
reimbursement.
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If
any
product candidates for which we may receive marketing approval fail to gain
market acceptance, our ability to generate product revenue in the future will
be
adversely affected.
We
face the risk of product liability claims and may not be able to obtain
insurance.
Our
business exposes us to the risk of product liability claims that is inherent
in
the testing, manufacturing, and marketing of drugs and related devices. Although
we have product liability and clinical trial liability insurance that we believe
is appropriate, this insurance is subject to deductibles and coverage
limitations. We may not be able to obtain or maintain adequate protection
against potential liabilities. If any of our product candidates are approved
for
marketing, we may seek additional insurance coverage. If we are unable to obtain
insurance at acceptable cost or on acceptable terms with adequate coverage
or
otherwise protect ourselves against potential product liability claims, we
will
be exposed to significant liabilities, which may cause a loss of revenue or
otherwise harm our business. These liabilities could prevent or interfere with
our product commercialization efforts. Defending a suit, regardless of merit,
could be costly, could divert management attention and might result in adverse
publicity, injury to our reputation, or reduced acceptance of our product
candidates in the market. If we are sued for any injury caused by any future
products, our liability could exceed our total assets.
Our
operations involve hazardous materials and we must comply with environmental
laws and regulations, which can be expensive.
Our
research and development activities involve the controlled use of hazardous
materials, including chemicals and radioactive and biological materials. Our
operations also produce hazardous waste products. We are subject in the United
States to a variety of federal, state and local regulations, and in Europe
to
European, national, state and local regulations, relating to the use, handling,
storage and disposal of these materials. We generally contract with third
parties for the disposal of such substances and store certain low-level
radioactive waste at our facility until the materials are no longer considered
radioactive. We cannot eliminate the risk of accidental contamination or injury
from these materials. We may be required to incur substantial costs to comply
with current or future environmental and safety regulations which could impose
greater compliance costs and increased risks and penalties associated with
violations. If an accident or contamination occurred, we would likely incur
significant costs associated with civil penalties or criminal fines, substantial
investigation and remediation costs, and costs associated with complying with
environmental laws and regulations. There can be no assurance that violations
of
environmental laws or regulations will not occur in the future as a result
of
the inability to obtain permits, human error, accident, equipment failure or
other causes. We do not have any insurance for liabilities arising from
hazardous materials. Compliance with environmental and safety laws and
regulations is expensive, and current or future environmental regulation may
impair our research, development or production efforts.
Risks
Relating to Our Intellectual Property and Litigation
We
may not be able to obtain or maintain adequate patents and other intellectual
property rights to protect our business and product candidates against
competitors.
Our
value
will be significantly enhanced if we are able to obtain adequate patents and
other intellectual property rights to protect our business and product
candidates against competitors. For that reason, we allocate significant
financial and personnel resources to the filing, prosecution, maintenance and
defense of patent applications, patents and trademarks claiming or covering
our
product candidates and key technology relating to these product
candidates.
To
date,
we have sought to protect our proprietary positions related to our important
proprietary technology, inventions and improvements by filing of patent
applications in the U.S., Europe and other jurisdictions. Because the patent
position of pharmaceutical and biopharmaceutical companies involves complex
legal and factual questions, the issuance, scope and enforceability of patents
cannot be predicted with certainty, and we cannot be certain that patents will
be issued on pending or future patent applications that cover our product
candidates and technologies. Claims could be restricted in prosecution that
might lead to a scope of protection which is of minor value for a particular
product candidate. Patents, if issued, may be challenged and sought to be
invalidated by third parties in litigation. In addition, U.S. patents and
patent applications may also be subject to interference proceedings, and
U.S. patents may be subject to reexamination proceedings in the
U.S. Patent and Trademark Office. European patents may be subject to
opposition proceedings in the European Patent Office. Patents might be
invalidated in national jurisdictions. Similar proceedings may be available
in
countries outside of Europe or the U.S. These proceedings could result in
either a loss of the patent or a denial of the patent application or loss or
reduction in the scope of one or more of the claims of the patent or patent
application. Thus, any patents that we own or license from others may not
provide any protection against competitors. Furthermore, an adverse decision
in
an interference proceeding could result in a third party receiving the patent
rights sought by us, which in turn could affect our ability to market a
potential product or product candidate to which that patent filing was directed.
Our pending patent applications, those that we may file in the future, or those
that we may license from third parties may not result in patents being issued.
If issued, they may not provide us with proprietary protection or competitive
advantages against competitors with similar technology. Furthermore, others
may
independently develop similar technologies or duplicate any technology that
we
have developed, which fall outside the scope of our patents. Products or
technology could also be copied by competitors after expiration of the patent
life. Furthermore, claims of employees or former employees of Micromet related
to their inventorship or compensation pursuant to the German Act on Employees’
Inventions may lead to legal disputes.
We
rely
on third-party payment services and external law firms for the payment of
foreign patent annuities and other fees. Non-payment or delay in payment of
such
fees, whether intentional or unintentional, may result in loss of patents or
patent rights important to our business.
We
may incur substantial costs enforcing our patents against third parties. If
we
are unable to protect our intellectual property rights, our competitors may
develop and market products with similar features that may reduce demand for
our
potential products.
We
own or
control a substantial portfolio of issued patents. From time to time, we may
become aware of third parties that undertake activities that infringe on our
patents. We may decide to grant those third parties a license under our patents,
or to enforce the patents against those third parties by pursuing an
infringement claim in litigation. If we initiate patent infringement litigation,
it could consume significant financial and management resources, regardless
of
the merit of the claims or the outcome of the litigation. The outcome of patent
litigation is subject to uncertainties that cannot be adequately quantified
in
advance, including the demeanor and credibility of witnesses and the identity
of
the adverse party, especially in biotechnology-related patent cases that may
turn on the testimony of experts as to technical facts upon which experts may
reasonably disagree. Some of our competitors may be able to sustain the costs
of
such litigation or proceedings more effectively than we can because of their
substantially greater financial resources. Uncertainties resulting from the
initiation and continuation of patent litigation or other proceedings could
harm
our ability to compete in the marketplace.
Our
ability to enforce our patents may be restricted under applicable law. Many
countries, including certain countries in Europe, have compulsory licensing
laws
under which a patent owner may be compelled to grant licenses to third parties.
For example, compulsory licenses may be required in cases where the patent
owner
has failed to “work” the invention in that country, or the third-party has
patented improvements. In addition, many countries limit the enforceability
of
patents against government agencies or government contractors. In these
countries, the patent owner may have limited remedies, which could materially
diminish the value of the patent. Moreover, the legal systems of certain
countries, particularly certain developing countries, do not favor the
aggressive enforcement of patent and other intellectual property rights, which
makes it difficult to stop infringement. In addition, our ability to enforce
our
patent rights depends on our ability to detect infringement. It is difficult
to
detect infringers who do not advertise the compounds that are used in their
products or the methods they use in the research and development of their
products. If we are unable to enforce our patents against infringers, it could
have a material adverse effect on our competitive position, results of
operations and financial condition.
If
we are not able to protect and control our unpatented trade secrets, know-how
and other technological innovation, we may suffer competitive
harm.
We
rely
on proprietary trade secrets and unpatented know-how to protect our research,
development and manufacturing activities and maintain our competitive position,
particularly when we do not believe that patent protection is appropriate or
available. However, trade secrets are difficult to protect. We attempt to
protect our trade secrets and unpatented know-how by requiring our employees,
consultants and advisors to execute confidentiality and non-use agreements.
We
cannot guarantee that these agreements will provide meaningful protection,
that
these agreements will not be breached, that we will have an adequate remedy
for
any such breach, or that our trade secrets or proprietary know-how will not
otherwise become known or independently developed by a third party. Our trade
secrets, and those of our present or future collaborators that we utilize by
agreement, may become known or may be independently discovered by others, which
could adversely affect the competitive position of our product candidates.
If
any trade secret, know-how or other technology not protected by a patent or
intellectual property right were disclosed to, or independently developed by
a
competitor, our business, financial condition and results of operations could
be
materially adversely affected.
If
third parties claim that our product candidates or technologies infringe their
intellectual property rights, we may become involved in expensive patent
litigation, which could result in liability for damages or require us to stop
our development and commercialization of our product candidates after they
have
been approved and launched in the market, or we could be forced to obtain a
license and pay royalties under unfavorable terms.
Our
commercial success will depend in part on not infringing the patents or
violating the proprietary rights of third parties. Competitors or third parties
may obtain patents that may claim the composition, manufacture or use of our
product candidates, or the technology required to perform research and
development activities relating to our product candidates.
From
time
to time we receive correspondence inviting us to license patents from third
parties. While we believe that our pre-commercialization activities fall within
the scope of an available exemption against patent infringement provided in
the
United States by 35 U.S.C. § 271(e) and by similar research exemptions
in Europe, claims may be brought against us in the future based on patents
held
by others. Also, we are aware of patents and other intellectual property rights
of third parties relating to our areas of practice, and we know that others
have
filed patent applications in various countries that relate to several areas
in
which we are developing product candidates. Some of these patent applications
have already resulted in patents and some are still pending. The pending patent
applications may also result in patents being issued. In addition, the
publication of patent applications occurs with a certain delay after the date
of
filing, so we may not be aware of all relevant patent applications of third
parties at a given point in time. Further, publication of discoveries in the
scientific or patent literature often lags behind actual discoveries, so we
may
not be able to determine whether inventions claimed in patent applications
of
third parties have been made before or after the date on which inventions
claimed in our patent applications and patents have been made. All issued
patents are entitled to a presumption of validity in many countries, including
the United States and many European countries. Issued patents held by
others may therefore limit our freedom to operate unless and until these patents
expire or are declared invalid or unenforceable in a court of applicable
jurisdiction. For example, we are aware that GlaxoSmithKline holds a European
patent covering the administration of adecatumumab in combination with taxotere,
which is the combination that we are currently testing in a phase 1 study.
We
have filed an opposition proceeding against this patent with the European Patent
Office seeking to have the patent invalidated. We may not be successful in
this
proceeding, and if it is not resolved in our favor, we could be required to
obtain a license under this patent from GlaxoSmithKline, which we may not be
able to obtain on commercially reasonable terms, if at all.
We
and
our collaborators may not have rights under some patents that may cover the
composition of matter, manufacture or use of product candidates that we seek
to
develop and commercialize, drug targets to which our product candidates bind,
or
technologies that we use in our research and development activities. As a
result, our ability to develop and commercialize our product candidates may
depend on our ability to obtain licenses or other rights under these patents.
The third parties who own or control such patents may be unwilling to grant
those licenses or other rights to us or our collaborators under terms that
are
commercially viable or at all. Third parties who own or control these patents
could bring claims based on patent infringement against us or our collaborators
and seek monetary damages and to enjoin further clinical testing, manufacturing
and marketing of the affected product candidates or products. There has been,
and we believe that there will continue to be, significant litigation in the
pharmaceutical industry regarding patent and other intellectual property rights.
If a third party sues us for patent infringement, it could consume significant
financial and management resources, regardless of the merit of the claims or
the
outcome of the litigation.
If
a
third party brings a patent infringement suit against us and we do not settle
the patent infringement suit and are not successful in defending against the
patent infringement claims, we could be required to pay substantial damages
or
we or our collaborators could be forced to stop or delay research, development,
manufacturing or sales of the product or product candidate that is claimed
by
the third party’s patent. We or our collaborators may choose to seek, or be
required to seek, a license from the third party and would most likely be
required to pay license fees or royalties or both. However, there can be no
assurance that any such license will be available on acceptable terms or at
all.
Even if we or our collaborators were able to obtain a license, the rights may
be
nonexclusive, which would give our competitors access to the same intellectual
property. Ultimately, we could be prevented from commercializing a product
candidate, or forced to cease some aspect of our business operations as a result
of patent infringement claims, which could harm our business.
Our
success depends on our ability to maintain and enforce our licensing
arrangements with various third party licensors.
We
are
party to intellectual property licenses and agreements that are important to
our
business, and we expect to enter into similar licenses and agreements in the
future. These licenses and agreements impose various research, development,
commercialization, sublicensing, milestone payments, indemnification, insurance
and other obligations on us. Moreover, certain of our license agreements contain
an obligation for us to make payments to our licensors based upon revenues
received in connection with such licenses. If we or our collaborators fail
to
perform under these agreements or otherwise breach obligations thereunder,
our
licensors may terminate these agreements, we could lose licenses to intellectual
property rights that are important to our business and we could be required
to
pay damages to our licensors. Any such termination could materially harm our
ability to develop and commercialize the product candidate that is the subject
of the agreement, which could have a material adverse impact on our results
of
operations.
If
licensees or assignees of our intellectual property rights breach any of the
agreements under which we have licensed or assigned our intellectual property
to
them, we could be deprived of important intellectual property rights and future
revenue.
We
are a
party to intellectual property out-licenses, collaborations and agreements
that
are important to our business, and we expect to enter into similar agreements
with third parties in the future. Under these agreements, we license or transfer
intellectual property to third parties and impose various research, development,
commercialization, sublicensing, royalty, indemnification, insurance, and other
obligations on them. If a third party fails to comply with these requirements,
we generally retain the right to terminate the agreement and to bring a legal
action in court or in arbitration. In the event of breach, we may need to
enforce our rights under these agreements by resorting to arbitration or
litigation. During the period of arbitration or litigation, we may be unable
to
effectively use, assign or license the relevant intellectual property rights
and
may be deprived of current or future revenues that are associated with such
intellectual property, which could have a material adverse effect on our results
of operations and financial condition.
We
may be subject to damages resulting from claims that we or our employees have
wrongfully used or disclosed alleged trade secrets of their former
employers.
Many
of
our employees were previously employed at other biotechnology or pharmaceutical
companies, including our competitors or potential competitors. Although no
claims against us are currently pending, we may be subject to claims that these
employees or we have inadvertently or otherwise used or disclosed trade secrets
or other proprietary information of their former employers. Litigation may
be
necessary to defend against these claims. Even if we are successful in defending
against these claims, litigation could result in substantial costs and be a
distraction to management. If we fail in defending such claims, in addition
to
paying money claims, we may lose valuable intellectual property rights or
personnel. A loss of key personnel or their work product could hamper or prevent
our ability to commercialize certain product candidates.
Risks
Relating to Manufacturing and Sales of Products
We
depend on our collaborators and third-party manufacturers to produce most,
if
not all, of our product candidates and if these third parties do not
successfully manufacture these product candidates our business will be
harmed.
We
have
no manufacturing experience or manufacturing capabilities for the production
of
our product candidates for clinical trials or commercial sale. In order to
continue to develop product candidates, apply for regulatory approvals, and
commercialize our product candidates following approval, we or our collaborators
must be able to manufacture or contract with third parties to manufacture our
product candidates in clinical and commercial quantities, in compliance with
regulatory requirements, at acceptable costs and in a timely manner. The
manufacture of our product candidates may be complex, difficult to accomplish
and difficult to scale-up when large-scale production is required. Manufacture
may be subject to delays, inefficiencies and poor or low yields of quality
products. The cost of manufacturing our product candidates may make them
prohibitively expensive. If supplies of any of our product candidates or related
materials become unavailable on a timely basis or at all or are contaminated
or
otherwise lost, clinical trials by us and our collaborators could be seriously
delayed. This is due to the fact that such materials are time-consuming to
manufacture and cannot be readily obtained from third-party
sources.
To
the
extent that we or our collaborators seek to enter into manufacturing
arrangements with third parties, we and such collaborators will depend upon
these third parties to perform their obligations in a timely and effective
manner and in accordance with government regulations. Contract manufacturers
may
breach their manufacturing agreements because of factors beyond our control
or
may terminate or fail to renew a manufacturing agreement based on their own
business priorities at a time that is costly or inconvenient for us. If
third-party manufacturers fail to perform their obligations, our competitive
position and ability to generate revenue may be adversely affected in a number
of ways, including:
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we
and our collaborators may not be able to initiate or continue clinical
trials of product candidates that are under
development;
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we
and our collaborators may be delayed in submitting applications for
regulatory approvals for our product
candidates; and
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we
and our collaborators may not be able to meet commercial demands
for any
approved products.
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We
have no sales, marketing or distribution experience and will depend
significantly on third parties who may not successfully sell our product
candidates following approval.
We
have
no sales, marketing or product distribution experience. If we receive required
regulatory approvals to market any of our product candidates, we plan to rely
primarily on sales, marketing and distribution arrangements with third parties,
including our collaborators. For example, as part of our agreements with Merck
Serono, MedImmune, Nycomed and TRACON, we have granted these companies the
right
to market and distribute products resulting from such collaborations, if any
are
ever successfully developed. We may have to enter into additional marketing
arrangements in the future and we may not be able to enter into these additional
arrangements on terms that are favorable to us, if at all. In addition, we
may
have limited or no control over the sales, marketing and distribution activities
of these third parties, and sales through these third parties could be less
profitable to us than direct sales. These third parties could sell competing
products and may devote insufficient sales efforts to our product candidates
following approval. As a result, our future revenues from sales of our product
candidates, if any, will be materially dependent upon the success of the efforts
of these third parties.
We
may
seek to co-promote products with our collaborators, or to independently market
products that are not already subject to marketing agreements with other
parties. If we determine to perform sales, marketing and distribution functions
ourselves, then we could face a number of additional risks,
including:
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we
may not be able to attract and build an experienced marketing staff
or
sales force;
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the
cost of establishing a marketing staff or sales force may not be
justifiable in light of the revenues generated by any particular
product;
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our
direct sales and marketing efforts may not be successful;
and
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we
may face competition from other products or sales forces with greater
resources than our own sales force.
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CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
Any
statements in this prospectus about our expectations, beliefs, plans,
objectives, assumptions or future events or performance are not historical
facts
and are forward-looking statements. Such forward-looking statements include
statements regarding the efficacy, safety and intended utilization of our
product candidates, the conduct and results of future clinical trials, plans
regarding regulatory filings, future research and clinical trials and plans
regarding partnering activities, and our goal of monitoring our internal
controls for financial reporting and making modifications as necessary. You
can
identify these forward-looking statements by the use of words or phrases such
as
“believe,” “may,” “could,” “will,” “possible,” “can,” “estimate,” “continue,”
“ongoing,” “consider,” “anticipate,” “intend,” “seek,” “plan,” “expect,” “deem,”
“should,” “would” or “assume” or the negative of these terms, or other
comparable terminology, although not all forward-looking statements contain
these words. Among the factors that could cause actual results to differ
materially from those indicated in the forward-looking statements are risks
and
uncertainties inherent in our business including, without limitation, the
progress, timing and success of our clinical trials; difficulties or delays
in
development, testing, obtaining regulatory approval for producing and marketing
our product candidates; regulatory developments in the United States or in
foreign countries; the risks associated with our reliance on collaborations
for
the development and commercialization of our product candidates; unexpected
adverse side effects or inadequate therapeutic efficacy of our product
candidates that could delay or prevent product development or commercialization,
or that could result in recalls or product liability claims; our ability to
attract and retain key scientific, management or commercial personnel; the
loss
of key scientific, management or commercial personnel; the size and growth
potential of the potential markets for our product candidates and our ability
to
serve those markets; the scope and validity of patent protection for our product
candidates; our ability to establish and maintain strategic collaborations
or to
otherwise obtain additional financing to support our operations; competition
from other pharmaceutical or biotechnology companies; successful administration
of our business and financial reporting capabilities, including the successful
remediation of material weaknesses in our internal control our financial
reporting; and other risks detailed in the discussions set forth above
under the caption “Risk Factors”; and as discussed in our Annual Report on
Form 10-K for the year ended December 31, 2007 filed with the SEC on March
14,
2008 and our Quarterly Reports on Form 10-Q for the quarters ended March
31, 2008, June 30, 2008 and September 30, 2008 filed with the
SEC on May 9, 2008, August 8, 2008 and November 6,
2008, respectively.
Although
we believe that the expectations reflected in our forward-looking statements
are
reasonable, we cannot guarantee future results, events, levels of activity,
performance or achievement. We undertake no obligation to publicly update or
revise any forward-looking statements, whether as a result of new information,
future events or otherwise, unless required by law.
USE
OF PROCEEDS
We
are
registering these shares pursuant to the registration rights granted to the
selling stockholders in connection with our October 2008 private placement.
We
are not selling any securities under this prospectus and will not receive any
proceeds from sales of the shares of common stock sold from time to time under
this prospectus by the selling stockholders.
Some
of
the shares covered by this prospectus are issuable upon exercise of warrants
to
purchase our common stock. Upon any exercise of the warrants for cash, the
selling stockholders would pay us the exercise price of the warrants, which
would be used for general corporate purposes. The cash exercise price of the
warrants is $4.63 per share of our common stock. Under certain conditions set
forth in the warrants, the warrants are exercisable on a cashless basis. If
any
warrants are exercised on a cashless basis, we would not receive any cash
payment from the selling stockholders upon the exercise of these
warrants.
We
have
agreed to pay all costs, expenses and fees relating to registering the shares
of
our common stock referenced in this prospectus. The selling stockholders will
pay any brokerage commissions or similar charges incurred for the sale of such
shares of our common stock.
SELLING
SECURITY HOLDERS
On
October 2, 2008, we issued an aggregate of 9,411,948 shares of common stock
and
warrants to purchase an additional 2,823,584 shares of common stock in a private
placement to various institutional and other accredited investors pursuant
to a
Securities Purchase Agreement. Pursuant to a Registration Rights Agreement
related to this private placement, we agreed to file a registration statement
of
which this prospectus is a part with the SEC to register the disposition of
the
shares of our common stock we issued in the private placement and shares of
common stock underlying the exercise of warrants, and to keep the registration
statement continuously effective until the earlier of (a) such time as all
such shares have been publicly sold by the selling stockholders, or (b) the
date
that is two years following the closing date, or October 2, 2010.
The
warrants issued to the purchasers in the private placement are exercisable
after
October 2, 2008 at an exercise price of $4.63 per share, and expire on October
2, 2013. Pursuant to conditions set forth in the warrants, the warrants are
exercisable under certain circumstances on a cashless basis. If certain changes
occur to our capitalization, such as a stock split or stock dividend of the
common stock, then the exercise price and number of shares issuable upon
exercise of the warrants will be adjusted appropriately.
We
have
included the shares issuable upon exercise of the warrants issued in the private
placement to the selling stockholders in this prospectus and related
registration statement.
The
following table sets forth:
|
·
|
the
name of each of the selling
stockholders;
|
|
·
|
the
number of shares of our common stock beneficially owned by each such
selling stockholder prior to this
offering;
|
|
·
|
the
percentage (if one percent or more) of common stock owned by each
such
selling stockholder prior to this
offering;
|
|
·
|
the
number of outstanding shares of our common stock being offered pursuant
to
this prospectus;
|
|
·
|
the
number of shares of our common stock issuable upon exercise of the
warrants issued in the private
placement;
|
|
·
|
the
number of shares of our common stock owned upon completion of this
offering; and
|
|
·
|
the
percentage (if one percent or more) of common stock owned by each
such
selling stockholder after this offering.
|
This
table is prepared based on information supplied to us by the selling
stockholders, and reflects holdings as of October 23, 2008. As used in this
prospectus, the term “selling stockholder” includes each of the selling
stockholders listed below, and any donees, pledges, transferees or other
successors in interest selling shares received after the date of this prospectus
from a selling stockholder as a gift, pledge, or other non-sale related
transfer. The aggregate number of shares in the columns “Number of
Outstanding Shares Being Offered” and “Shares Issuable Upon Exercise of
Warrants Being Offered” represents the total shares that a selling stockholder
may offer under this prospectus. Each selling stockholder may sell some, all
or
none of its shares. The number of shares in the column “Shares of Common Stock
Beneficially Owned After Offering” assumes that the selling stockholder sells
all of the shares covered by this prospectus. We do not know how long the
selling stockholders will hold the shares before selling them, and we currently
have no agreements, arrangements or understandings with the selling stockholders
regarding the sale of any of the shares. Each of the selling stockholders listed
below has certified that (i) it purchased the shares in the ordinary course
of
business, and (ii) at the time of purchase of the shares to be resold, it had
no
agreements or understandings, directly or indirectly, with any person to
distribute such shares.
Beneficial
ownership is determined in accordance with Rule 13d-3(d) promulgated by the
SEC
under the Securities Exchange Act of 1934, as amended, or the Exchange Act.
The
percentage of shares beneficially owned prior to the offering is based on
50,549,872 shares of our common stock actually outstanding as of October 23,
2008.
Except
as
noted in the footnotes to the table below, no selling stockholder has had,
within the past three years, any position, office, or material relationship
with
us or any of our predecessors or affiliates.
|
|
Shares of Common
Stock Beneficially
Owned Prior to the
Offering (1)
|
|
Number of
Outstanding
Shares Being
|
|
Shares
Issuable
Upon
Exercise of
Warrants
Being
|
|
Shares of Common
Stock Beneficially
Owned After Offering
(2)
|
|
|
|
|
|
Number
|
|
Percent
|
|
Offered
|
|
Offered (1)
|
|
Number
|
|
Percent
|
|
Foot-notes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abingworth
Bioventures V L.P.
|
|
|
2,215,448
|
|
|
4.4
|
%
|
|
1,117,647
|
|
|
335,294
|
|
|
762,507
|
|
|
1.5
|
%
|
|
(3
|
)
|
Abingworth
Bioequities Master Fund Ltd.
|
|
|
1,756,625
|
|
|
3.5
|
%
|
|
764,706
|
|
|
229,412
|
|
|
762,507
|
|
|
1.5
|
%
|
|
(3
|
)
|
ANMA
Venture GmbH
|
|
|
271,500
|
|
|
*
|
|
|
135,000
|
|
|
40,500
|
|
|
96,000
|
|
|
*
|
|
|
(4
|
)
|
Baker/Tisch
Investments, L.P.
|
|
|
13,769
|
|
|
*
|
|
|
3,678
|
|
|
1,103
|
|
|
8,988
|
|
|
*
|
|
|
(5
|
)
|
Baker
Bros. Investments II, L.P.
|
|
|
5,983
|
|
|
*
|
|
|
1,404
|
|
|
421
|
|
|
4,158
|
|
|
*
|
|
|
(6
|
)
|
Baker
Brothers Life Sciences, L.P.
|
|
|
3,464,074
|
|
|
6.8
|
%
|
|
848,427
|
|
|
254,528
|
|
|
2,361,119
|
|
|
4.6
|
%
|
|
(7
|
)
|
667,
L.P.
|
|
|
1,209,304
|
|
|
2.4
|
%
|
|
295,756
|
|
|
88,727
|
|
|
824,821
|
|
|
1.6
|
%
|
|
(8
|
)
|
14159,
L.P.
|
|
|
111,008
|
|
|
*
|
|
|
27,206
|
|
|
8,162
|
|
|
75,640
|
|
|
*
|
|
|
(9
|
)
|
John
Berriman
|
|
|
84,839
|
|
|
*
|
|
|
11,765
|
|
|
3,530
|
|
|
69,544
|
|
|
*
|
|
|
(10
|
)
|
CD-Venture
GmbH
|
|
|
920,000
|
|
|
1.8
|
%
|
|
400,000
|
|
|
120,000
|
|
|
400,000
|
|
|
*
|
|
|
(11
|
)
|
John
Costantino
|
|
|
4,203,943
|
|
|
8.1
|
%
|
|
11,765
|
|
|
3,530
|
|
|
4,188,648
|
|
|
8.1
|
%
|
|
(14
|
)
|
DAFNA
LifeScience Select Ltd.
|
|
|
948,213
|
|
|
1.9
|
%
|
|
529,856
|
|
|
158,957
|
|
|
259,400
|
|
|
*
|
|
|
(12
|
)
|
DAFNA
LifeScience Market Neutral Ltd.
|
|
|
221,908
|
|
|
*
|
|
|
116,753
|
|
|
35,026
|
|
|
70,129
|
|
|
*
|
|
|
(12
|
)
|
DAFNA
LifeScience Ltd.
|
|
|
172,221
|
|
|
*
|
|
|
94,862
|
|
|
28,459
|
|
|
48,900
|
|
|
*
|
|
|
(12
|
)
|
Deka
Luxembourg
|
|
|
616,912
|
|
|
1.2
|
%
|
|
176,471
|
|
|
52,941
|
|
|
387,500
|
|
|
*
|
|
|
(13
|
)
|
Index
Venture Growth Associates I Limited
|
|
|
3,043,530
|
|
|
5.9
|
%
|
|
2,341,177
|
|
|
702,353
|
|
|
-
|
|
|
-
|
|
|
|
|
Index
Venture Associates IV Limited
|
|
|
1,517,177
|
|
|
3.0
|
%
|
|
1,167,059
|
|
|
350,118
|
|
|
-
|
|
|
-
|
|
|
|
|
Yucca
Partners L.P. Jersey Branch
|
|
|
27,529
|
|
|
*
|
|
|
21,176
|
|
|
6,353
|
|
|
-
|
|
|
-
|
|
|
|
|
Peter
Johann
|
|
|
4,208,943
|
|
|
8.2
|
%
|
|
11,765
|
|
|
3,530
|
|
|
4,193,648
|
|
|
8.1
|
%
|
|
(14
|
)
|
Merlin
Nexus III, L.P.
|
|
|
2,727,128
|
|
|
5.4
|
%
|
|
705,883
|
|
|
211,765
|
|
|
1,809,480
|
|
|
3.6
|
%
|
|
(15
|
)
|
NGN
BioMed Opportunity I, L.P.
|
|
|
2,491,727
|
|
|
4.9
|
%
|
|
68,283
|
|
|
20,485
|
|
|
2,402,959
|
|
|
4.7
|
%
|
|
(14
|
)
|
NGN
BioMed Opportunity I GmbH & Co Beteiligungs KG
|
|
|
1,801,391
|
|
|
3.5
|
%
|
|
49,365
|
|
|
14,809
|
|
|
1,737,217
|
|
|
3.4
|
%
|
|
(14
|
)
|
Panacea
Fund, LLC
|
|
|
724,658
|
|
|
1.4
|
%
|
|
176,648
|
|
|
52,994
|
|
|
495,016
|
|
|
1.0
|
%
|
|
(16
|
)
|
Polar
Capital Funds plc — Healthcare Opportunity Fund
|
|
|
305,883
|
|
|
*
|
|
|
235,295
|
|
|
70,588
|
|
|
-
|
|
|
-
|
|
|
(17
|
)
|
Sio
Partners, LP
|
|
|
134,179
|
|
|
*
|
|
|
54,871
|
|
|
16,461
|
|
|
62,847
|
|
|
*
|
|
|
(18
|
)
|
Sio
Partners QP, LP
|
|
|
69,415
|
|
|
*
|
|
|
28,386
|
|
|
8,516
|
|
|
32,513
|
|
|
*
|
|
|
(18
|
)
|
Sio
Partners Offshore, Ltd.
|
|
|
26,559
|
|
|
*
|
|
|
10,861
|
|
|
3,258
|
|
|
12,440
|
|
|
*
|
|
|
(18
|
)
|
Joseph
P. Slattery
|
|
|
29,662
|
|
|
*
|
|
|
5,883
|
|
|
1,765
|
|
|
22,014
|
|
|
*
|
|
|
(19
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL
|
|
|
|
|
|
|
|
|
9,411,948
|
|
|
2,823,584
|
|
|
|
|
|
|
|
|
|
|
(1)
The
number of shares presented in this table as owned prior to this offering
includes all shares of common stock issuable upon exercise of the warrants
issued in private placement of our common stock, which closed on October 2,
2008, as evidenced by the Warrant Shares indicated across from each stockholder
in the column “Shares Issuable Upon Exercise of Warrants Being
Offered.”
(2)
The selling stockholders identified in this table may sell some, all, or none
of
the shares owned by them that are registered under the registration statement
of
which this prospectus forms a part. While we do not currently have knowledge
of
any agreements, arrangements, or understandings with respect to the sale of
any
of the shares registered hereunder (other than the registration rights agreement
referenced above), as required for purposes of this table, we are assuming
that
the selling stockholders will sell all of the shares indicated in the
table.
(3)
Abingworth LLP is the manager of Abingworth Bioequities Master Fund Ltd. and
Abingworth Bioventures V, L.P. Stephen Bunting, Jonathan MacQuitty, Michael
Bingham and Joseph Anderson are the investment committee of Abingworth LLP
and
as such share voting and investment control over the securities held by
Abingworth Bioequities Master Fund Ltd. and Abingworth Bioventures V, L.P.
Investment decisions for the investment funds managed by Abingworth Management
Ltd. and Abingworth LLP are made by investment committees comprised of
substantially the same individuals. Each of Abingworth Management Ltd and
Abingworth LLP may be deemed to beneficially own an additional 762,507 shares
of
common stock, which represents shares of common stock directly owned by
Abingworth Bioventures II SICAV, of which Abingworth Management Ltd. is the
manager. Each of Abingworth LLP, Abingworth Management Ltd., Abingworth
Bioequities Master Fund Ltd., Abingworth Bioventures V, L.P. and Abingworth
Bioventures II SICAV (each an “Abingworth Security Holder”) disclaim beneficial
ownership of such shares of common stock except for the shares, if any, such
Abingworth Security Holder holds of record.
(4)
Mathias Boehringer is the Chief Executive Officer of ANMA Venture GmbH and
as
such is deemed to possess voting and investment control over the shares held
by
this entity.
(5)
In
addition to the number of Shares and Warrant Shares being offered, the
shares beneficially owned before and after the offering include 8,988 shares
of
common stock owned directly by Baker/Tisch Investments, L.P., a limited
partnership of which the sole general partner is Baker/Tisch Capital, L.P.,
a
limited partnership of which the sole general partner is Baker/Tisch Capital
(GP), LLC. Felix J. Baker and Julian C. Baker are the managing members
of Baker/Tisch Capital (GP), LLC, and as such may be deemed to possess voting
and investment control over such shares. Messrs. Baker disclaim beneficial
ownership of these securities, except to the extent of their pecuniary interest
therein.
(6)
In
addition to the number of Shares and Warrant Shares being offered, the
shares beneficially owned before and after the offering include 2,848 shares
of
common stock and 1,310 shares of common stock issuable upon exercise of
immediately exercisable warrants owned directly by Baker Bros. Investments
II,
L.P. The sole general partner of Baker Bros. Investments II, L.P. is Baker
Bros.
Capital, L.P., a limited partnership of which the sole general partner is Baker
Bros. Capital (GP), LLC. Felix J. Baker and Julian C. Baker are the managing
members of Baker Bros. Capital (GP), LLC, and as such may be deemed to possess
voting and investment control over such shares. Messrs. Baker disclaim
beneficial ownership of these securities, except to the extent of their
pecuniary interest therein.
(7)
In
addition to the number of Shares and Warrant Shares being offered, the
shares beneficially owned before and after the offering include 1,847,071 shares
of common stock and 514,048 shares of common stock issuable upon exercise of
immediately exercisable warrants owned directly by Baker Brothers Life Sciences,
L.P., a limited partner of which the sole general parner is Baker Brothers
Life Sciences Capital, L.P., a limited partnership of which the sole general
partner is Baker Brothers Life Sciences Capital (GP), LLC. Julian C. Baker
and
Felix J. Baker are the managing members of Baker Brothers Life Sciences
Capital (GP), LLC, and as such may be deemed to possess voting and investment
control over such shares. Messrs. Baker disclaim beneficial ownership of these
securities, except to the extent of their pecuniary interest
therein.
(8)
In
addition to the number of Shares and Warrant Shares being offered, the
shares beneficially owned before and after the offering include 629,908 shares
of common stock and 194,913 shares of common stock issuable upon exercise of
immediately exercisable warrants owned directly by 667, L.P. (formerly Baker
Biotech Fund I, L.P.) The sole general partner of 667, L.P. is Baker Biotech
Capital, L.P., a limited partnership of which the sole general partner is Baker
Biotech Capital (GP), LLC. Julian C. Baker and Felix J. Baker are the managing
members of Baker Biotech Capital (GP), LLC, and as such may be deemed to possess
voting and investment control over such shares. Messrs. Baker disclaim
beneficial ownership of these securities, except to the extent of their
pecuniary interest therein.
(9)
In
addition to the number of Shares and Warrant Shares being offered, the
shares beneficially owned before and after the offering include 59,299 shares
of
common stock and 16,341 shares of common stock issuable upon exercise of
immediately exercisable warrants owned directly by 14159, L.P. The sole general
partner of 14159, L.P. is 14159 Capital, L.P., a limited partnership of which
the sole general partner is 14159 Capital (GP), LLC. Felix J. Baker and Julian
C. Baker are the managing members of 14159 Capital (GP), LLC, and as such may
be
deemed to possess voting and investment control over such shares. Messrs. Baker
disclaim beneficial ownership of these securities, except to the extent of
their
pecuniary interest therein.
(10)
In
addition to the number of Shares and Warrant Shares being offered, the
shares beneficially owned before and after the offering include 69,544 shares
of
common stock issuable upon exercise of stock options held by John E. Berriman,
a
director of the Company, and exercisable within sixty days of October 23,
2008.
(11)
Christopher Boehringer is the owner and Chief Executive Officer of CD-Venture
GmbH and as such is deemed to possess voting and investment control over the
shares held by this entity.
(12)
In
addition to the number of Shares and Warrant Shares being offered, the
shares beneficially owned before and after the offering include 259,400 shares
of common stock held by DAFNA LifeScience Select Ltd., 70,129 shares of common
stock held by DAFNA LifeScience Market Neutral Ltd. and 48,900 shares of common
stock held by DAFNA LifeScience Ltd. DAFNA Capital Management, LLC serves as
investment adviser of each of these entities and, in such capacity, exercises
sole voting and investment authority with respect to the shares held by these
entities. DAFNA Capital Management, LLC disclaims beneficial ownership of such
shares, except to the extent of its pecuniary interest therein, if
any.
(13)
Kai
Bruning is the manager of Deka Luxembourg and as such is deemed to possess
voting and investment control over the shares held by this entity.
(14)
In
addition to the number of Shares and Warrant Shares being offered, the
shares beneficially owned before and after the offering include 1,816,935 shares
held of record and immediately exercisable warrants to purchase 586,024 shares
by NGN Biomed Opportunity I, L.P., as well as 1,313,552 shares held of record
and immediately exercisable warrants to purchase 423,665 shares by NGN Biomed
Opportunity I GmbH & Co. Beteiligungs KG. Peter Johann, PhD., a director of
the Company, and John Costantino are managing general partners of NGN Capital
LLC, which is the sole general partner of the general partner of NGN Biomed
Opportunity I, L.P. and is also the managing limited partner of NGN Biomed
Opportunity I GmbH & Co. Beteiligungs KG. NGN Capital, LLC is the record
holder of 48,472 shares of common stock issuable upon exercise of stock options
and exercisable within sixty days of October 23, 2008. As a result, Dr. Johann
and Mr. Costantino may be deemed to share voting and dispositive power with
respect to the securities beneficially held by these entities and disclaim
beneficial ownership of the reported securities except to the extent of his
pecuniary interest therein.
The
number of shares of common stock beneficially owned prior to the offering also
includes 5,000 shares of common stock owned
directly
by Dr. Johann.
(15)
Dominique Semon is the general partner of Merlin Nexus III, L.P. and as such
is
deemed to possess voting and investment control over the shares held by this
entity.
(16)
In
addition to the number of Shares and Warrant Shares being offered, the
shares beneficially owned before and after the offering include 313,363 shares
of common stock and 181,653 shares of common stock issuable upon exercise of
immediately exercisable warrants beneficially owned by Panacea Fund, LLC.
William Harris Investors, Inc. is the Manager of Panacea Fund, LLC. Charles
Polsky, a fund manager of Panacea Fund, LLC, has voting and investment control
over the shares of common stock and warrants held by Panacea Fund,
LLC.
(17)
Polar Capital LLP is the investment manager of Polar Capital Funds PLC
- Healthcare Opportunities Fund and shares voting and dispositive power over
these shares with Nexus Gemini LP. Shares are held of record by NorTrust
Nominees Limited on behalf of Healthcare Opportunities Fund. Daniel Mahony
and
Gareth Powell are the controlling partners of Polar Capital LLP and as such
may
be deemed to possess voting and investment control over the shares held by
Polar
Capital Funds PLC - Healthcare Opportunities Fund.
(18)
Michael Castor is the general partner of Sio Partners, L.P. and Sio Partners
QP,
L.P., and is a director of Sio Partners Offshore, Ltd., and as such is deemed
to
possess voting and investment control over the shares held by these
entities.
(19)
In
addition to the number of Shares and Warrant Shares being offered, the
shares beneficially owned before and after the offering include 22,014 shares
of
common stock issuable upon exercise of a stock option held by Joseph P.
Slattery, a director of the Company, and exercisable within sixty days of
October 23, 2008.
We
are
registering the shares of Common Stock issued to the selling stockholders and
issuable upon exercise of the warrants issued to the selling stockholders to
permit the resale of these shares of Common Stock by the holders of the shares
of Common Stock and warrants from time to time after the date of this
prospectus. We will not receive any of the proceeds from the sale by the selling
stockholders of the shares of Common Stock. We will bear all fees and expenses
incident to our obligation to register the shares of Common Stock.
The
selling stockholders may sell all or a portion of the shares of Common Stock
beneficially owned by them and offered hereby from time to time directly or
through one or more underwriters, broker-dealers or agents. If the shares of
Common Stock are sold through underwriters or broker-dealers, the selling
stockholders will be responsible for underwriting discounts or commissions
or
agent's commissions. The shares of Common Stock may be sold on any national
securities exchange or quotation service on which the securities may be listed
or quoted at the time of sale, in the over-the-counter market or in transactions
otherwise than on these exchanges or systems or in the over-the-counter market
and in one or more transactions at fixed prices, at prevailing market prices
at
the time of the sale, at varying prices determined at the time of sale, or
at
negotiated prices. These sales may be effected in transactions, which may
involve crosses or block transactions. The selling stockholders may use any
one
or more of the following methods when selling shares:
·
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ordinary
brokerage transactions and transactions in which the broker-dealer
solicits purchasers;
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|
block
trades in which the broker-dealer will attempt to sell the shares
as agent
but may position and resell a portion of the block as principal to
facilitate the transaction;
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purchases
by a broker-dealer as principal and resale by the broker-dealer for
its
account;
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an
exchange distribution in accordance with the rules of the applicable
exchange;
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privately
negotiated transactions;
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|
settlement
of short sales entered into after the effective date of the registration
statement of which this prospectus is a
part;
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|
broker-dealers
may agree with the selling stockholders to sell a specified number
of such
shares at a stipulated price per
share;
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through
the writing or settlement of options or other hedging transactions,
whether such options are listed on an options exchange or
otherwise;
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a
combination of any such methods of sale;
and
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any
other method permitted pursuant to applicable
law.
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The
selling stockholders also may resell all or a portion of the shares in open
market transactions in reliance upon Rule 144 under the Securities Act of
1933, as amended, or the Securities Act, as permitted by that rule, or
Section 4(1) under the Securities Act, if available, rather than under this
prospectus, provided that they meet the criteria and conform to the requirements
of those provisions.
Broker-dealers
engaged by the selling stockholders may arrange for other broker-dealers to
participate in sales. If the selling stockholders effect such transactions
by
selling shares of Common Stock to or through underwriters, broker-dealers or
agents, such underwriters, broker-dealers or agents may receive commissions
in
the form of discounts, concessions or commissions from the selling stockholders
or commissions from purchasers of the shares of Common Stock for whom they
may
act as agent or to whom they may sell as principal. Such commissions will be
in
amounts to be negotiated, but, except as set forth in a supplement to this
Prospectus, in the case of an agency transaction will not be in excess of a
customary brokerage commission in compliance with NASD Rule 2440; and in the
case of a principal transaction a markup or markdown in compliance with NASD
IM-2440.
In
connection with sales of the shares of Common Stock or otherwise, the selling
stockholders may enter into hedging transactions with broker-dealers or other
financial institutions, which may in turn engage in short sales of the shares
of
Common Stock in the course of hedging in positions they assume. The selling
stockholders may also sell shares of Common Stock short and if such short sale
shall take place after the date that the registration statement, of which this
prospectus forms a part, is declared effective by the SEC, the selling
stockholders may deliver shares of Common Stock covered by this prospectus
to
close out short positions and to return borrowed shares in connection with
such
short sales. The selling stockholders may also loan or pledge shares of Common
Stock to broker-dealers that in turn may sell such shares, to the extent
permitted by applicable law. The selling stockholders may also enter into option
or other transactions with broker-dealers or other financial institutions or
the
creation of one or more derivative securities which require the delivery to
such
broker-dealer or other financial institution of shares offered by this
prospectus, which shares such broker-dealer or other financial institution
may
resell pursuant to this prospectus (as supplemented or amended to reflect such
transaction). Notwithstanding the foregoing, the selling stockholders have
been
advised that they may not use shares offered in this prospectus to
cover short sales of our common stock made prior to the date the registration
statement, of which this prospectus forms a part, has been declared effective
by
the SEC.
The
selling stockholders may, from time to time, pledge or grant a security interest
in some or all of the warrants or shares of Common Stock owned by them and,
if
they default in the performance of their secured obligations, the pledgees
or
secured parties may offer and sell the shares of Common Stock from time to
time
pursuant to this prospectus or any amendment to this prospectus under Rule
424(b)(3) or other applicable provision of the Securities Act, amending, if
necessary, the list of selling stockholders to include the pledgee, transferee
or other successors in interest as selling stockholders under this prospectus.
The selling stockholders also may transfer and donate the shares of Common
Stock
in other circumstances in which case the transferees, donees, pledgees or other
successors in interest will be the selling beneficial owners for purposes of
this prospectus.
The
selling stockholders and any broker-dealer or agents participating in the
distribution of the shares of Common Stock may be deemed to be “underwriters”
within the meaning of Section 2(11) of the Securities Act in connection with
such sales. In such event, any commissions paid, or any discounts or concessions
allowed to, any such broker-dealer or agent and any profit on the resale of
the
shares purchased by them may be deemed to be underwriting commissions or
discounts under the Securities Act. Selling Stockholders who are “underwriters”
within the meaning of Section 2(11) of the Securities Act will be subject to
the
applicable prospectus delivery requirements of the Securities Act including
Rule
172 thereunder and may be subject to certain statutory liabilities of, including
but not limited to, Sections 11, 12 and 17 of the Securities Act and
Rule 10b-5 under the Exchange Act.
Each
selling stockholder has informed us that it is not a registered broker-dealer
and does not have any written or oral agreement or understanding, directly
or
indirectly, with any person to distribute the Common Stock. Upon our being
notified in writing by a selling stockholder that any material arrangement
has
been entered into with a broker-dealer for the sale of common stock through
a
block trade, special offering, exchange distribution or secondary distribution
or a purchase by a broker or dealer, a supplement to this prospectus will be
filed, if required, pursuant to Rule 424(b) under the Securities Act, disclosing
(i) the name of each such selling stockholder and of the participating
broker-dealer(s), (ii) the number of shares involved, (iii) the price at which
such the shares of Common Stock were sold, (iv) the commissions paid or
discounts or concessions allowed to such broker-dealer(s), where applicable,
(v)
that such broker-dealer(s) did not conduct any investigation to verify the
information set out or incorporated by reference in this prospectus, and (vi)
other facts material to the transaction. In no event shall any broker-dealer
receive fees, commissions and markups, which, in the aggregate, would exceed
eight percent (8%).
Under
the
securities laws of some states, the shares of Common Stock may be sold in such
states only through registered or licensed brokers or dealers. In addition,
in
some states the shares of Common Stock may not be sold unless such shares have
been registered or qualified for sale in such state or an exemption from
registration or qualification is available and is complied with.
There
can
be no assurance that any selling stockholder will sell any or all of the shares
of Common Stock registered pursuant to the shelf registration statement, of
which this prospectus forms a part.
Each
selling stockholder and any other person participating in such distribution
will
be subject to applicable provisions of the Exchange Act, and the rules and
regulations thereunder, including, without limitation, to the extent applicable,
Regulation M of the Exchange Act, which may limit the timing of purchases and
sales of any of the shares of Common Stock by the selling stockholder and any
other participating person. To the extent applicable, Regulation M may also
restrict the ability of any person engaged in the distribution of the shares
of
Common Stock to engage in market-making activities with respect to the shares
of
Common Stock. All of the foregoing may affect the marketability of the shares
of
Common Stock and the ability of any person or entity to engage in market-making
activities with respect to the shares of Common Stock.
We
will
pay all expenses of the registration of the shares of Common Stock pursuant
to
the registration rights agreement, including, without limitation, SEC filing
fees and expenses of compliance with state securities or “blue sky” laws;
provided
,
however
, that
each selling stockholder will pay all underwriting discounts and selling
commissions, if any and any related legal expenses incurred by it. We will
indemnify the selling stockholders against certain liabilities, including some
liabilities under the Securities Act, in accordance with the registration rights
agreement, or the selling stockholders will be entitled to contribution. We
may
be indemnified by the selling stockholders against civil liabilities, including
liabilities under the Securities Act, that may arise from any written
information furnished to us by the selling stockholders specifically for use
in
this prospectus, in accordance with the registration rights agreement, or we
may
be entitled to contribution.
The
validity of the securities being offered hereby will be passed upon by Cooley
Godward Kronish LLP, Reston, Virginia.
EXPERTS
The
consolidated financial statements of Micromet, Inc. appearing in Micromet,
Inc.’s Annual Report on Form 10-K for the year ended December 31, 2007, and the
effectiveness of Micromet, Inc.’s internal control over financial reporting as
of December 31, 2007, have been audited by Ernst & Young AG WPG, independent
registered public accounting firm, as set forth in their reports thereon (which
conclude, among other things, that Micromet, Inc. did not maintain effective
internal control over financial reporting as of December 31, 2007, based on
Internal Control—Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission, because of the effects of the material
weaknesses described therein), included therein, and incorporated herein by
reference. Such consolidated financial statements have been incorporated herein
by reference in reliance upon such reports given on the authority of such firm
as experts in accounting and auditing.
We
file
electronically with the SEC our annual reports on Form 10-K, quarterly interim
reports on Form 10-Q, current reports on Form 8-K, and amendments to those
reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange
Act. We make available on or through our website, free of charge, copies of
these reports as soon as reasonably practicable after we electronically file
or
furnish it to the SEC. You can also request copies of such documents by
contacting our Investor Relations Department at (240) 235-0250 or sending an
email to investors@micromet-inc.com. You may read and copy any document we
file
at the SEC’s Public Reference Room at 100 F Street, N.E., Washington, D.C.
20549. Please call the SEC at 1-800-SEC-0330 for more information about the
operation of the Public Reference Room. The SEC maintains an Internet site
that
contains reports, proxy and information statements, and other information
regarding issuers that file electronically with the SEC, including Micromet.
The
SEC’s Internet site can be found at http://www.sec.gov
.
We
incorporate by reference into this prospectus the documents. Except as set
forth
below, the SEC file number for the documents incorporated by reference in this
prospectus is 0-50440. We incorporate by reference the following information
that has been filed with the SEC:
|
our
current report on Form 8-K filed with the SEC on March 13, 2008 (except
for the information furnished under Item 2.02 or any related
exhibit);
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our
annual report on Form 10-K for the year ended December 31, 2007 filed
with
the SEC on March 14, 2008;
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our
current report on Form 8-K filed with the SEC on March 31,
2008;
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our
definitive proxy statement for our 2008 annual meeting of stockholders
filed with the SEC on April 29, 2008 and additional definitive materials
filed on the same date;
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our
current report on Form 8-K filed with the SEC on May 8, 2008 (except
for
the information furnished under Item 2.02 or any related
exhibit);
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our
quarterly report on Form 10-Q for the quarterly period ended March
31,
2008 filed with the SEC on May 9,
2008;
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our
current report on Form 8-K filed with the SEC on June 30,
2008;
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·
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our
current report on Form 8-K filed with the SEC on August 7, 2008 (except
for the information furnished under Item 2.02 or any related
exhibit);
|
·
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our
quarterly report on Form 10-Q for the quarterly period ended June
30, 2008
filed with the SEC on August 8,
2008;
|
·
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our
current report on Form 8-K filed with the SEC on September 2,
2008;
|
·
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our
current report on Form 8-K filed with the SEC on September 5,
2008;
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·
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our
current report on Form 8-K filed with the SEC on October 6,
2008;
|
·
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our
current report on Form 8 K filed with the SEC on November 6, 2008
(except
for the information furnished under Item 2.02 or any related
exhibit);
|
·
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our
current report on Form 8-K filed with the SEC on November 19,
2008;
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·
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our
quarterly report on Form 10-Q for the quarterly period ended September
30,
2008 filed with the SEC on November 6,
2008;
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·
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the
description of our common stock contained in our registration statement
on
Form 8-A registering our common stock under Section 12 of the Exchange
Act, filed with the SEC on October 24, 2003, including any amendments
or
reports filed for the purpose of updating that description;
and
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·
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the
description of our Series A Junior Participating Preferred Stock
Purchase
Rights (the “Rights”) contained in our registration statement on Form 8-A
registering the Rights under Section 12 of the Exchange Act, filed
with
the SEC on November 12, 2004, including any amendments or reports
filed
for the purpose of updating that
description.
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In
addition, all filings that we make with the SEC pursuant to the Exchange Act
after the initial filing date of the registration statement, of which this
prospectus forms a part, and prior to the effectiveness of the registration
statement shall be deemed to be incorporated by reference into this
prospectus.
Any
information in any of the foregoing documents will automatically be deemed
to be
modified or superseded to the extent that information in this prospectus or
in a
later filed document that is incorporated or deemed to be incorporated herein
by
reference modifies or replaces such information.
We
also
incorporate by reference any future filings (other than current reports
furnished under Item 2.02 or Item 7.01 of Form 8-K and exhibits filed on such
form that are related to such items) made with the SEC pursuant to Sections
13(a), 13(c), 14 or 15(d) of the Exchange Act, until we file a post-effective
amendment which indicates the termination of the offering of the securities
made
by this prospectus. Information in such future filings updates and supplements
the information provided in this prospectus. Any statements in any such future
filings will automatically be deemed to modify and supersede any information
in
any document we previously filed with the SEC that is incorporated or deemed
to
be incorporated herein by reference to the extent that statements in the later
filed document modify or replace such earlier statements.
We
will
provide to each person, including any beneficial owner, to whom a prospectus
is
delivered, without charge upon written or oral request, a copy of any or all
of
the documents that are incorporated by reference into this prospectus but not
delivered with the prospectus, including exhibits which are specifically
incorporated by reference into such documents. Requests should be directed
to:
Investor Relations, Micromet, Inc., 6707 Democracy Boulevard, Suite 505,
Bethesda, Maryland 20817, telephone (240) 752-1420.