Filed Pursuant to Rule 424(b)(5)
Registration No.
333-167754
PROSPECTUS
EntreMed,
Inc.
Up to
403,550 shares of our Common Stock, $0.01 Par Value
The
persons listed in this prospectus under “Selling Stockholders” may offer and
sell up to 403,550 shares of our common stock. The shares listed in this
prospectus were issued as consideration for the satisfaction, in April 2010, of
a milestone payment as set forth in the merger agreement executed in connection
with our acquisition of Miikana Therapeutics Inc. in January
2006. Information on the selling stockholders, and the times
and manner in which they may offer and sell shares of our common stock under
this prospectus, is provided under “Selling Stockholders” and “Plan of
Distribution.”
We will
not receive any proceeds from the sale of these shares by the selling
stockholders.
Our
common stock is quoted on the Nasdaq Capital Market and traded under the symbol
“ENMD.” On July 13, 2010, the last reported sale price of our common
stock was $2.67 per share.
On July
1, 2010, we affected a one-for-eleven reverse stock split of our common
stock.
Our
principal executive offices are located at 9640 Medical Center Drive, Rockville,
Maryland 20850 and our telephone number is (240) 864-2600.
________________
See “Risk
Factors” beginning on page 3 for a discussion of certain material factors that
you should consider in connection with an investment in our
securities.
________________
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 July 12, 2010
TABLE OF
CONTENTS
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PAGE
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INFORMATION
ABOUT ENTREMED
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2
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RISK
FACTORS
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3
|
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
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13
|
USE
OF PROCEEDS
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14
|
SELLING
STOCKHOLDERS
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14
|
PLAN
OF DISTRIBUTION
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17
|
LEGAL
MATTERS
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18
|
EXPERTS
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18
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INCORPORATION
OF CERTAIN DOCUMENTS BY REFERENCE
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19
|
WHERE
YOU CAN FIND MORE INFORMATION
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20
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You
should rely only on the information provided in this prospectus, including the
information incorporated by reference. We have not authorized anyone to provide
you with different information. You should not assume that the information in
this prospectus, or any supplement to this prospectus, is accurate at any date
other than the date indicated on the cover page of these documents.
We have
not taken any action to permit a public offering of the shares of common stock
outside the United States or to permit the possession or distribution of this
prospectus outside the United States. Persons outside the United States who come
into possession of this prospectus must inform themselves about and observe any
restrictions relating to the offering of the shares of common stock and the
distribution of this prospectus outside of the United States.
INFORMATION
ABOUT ENTREMED
We are a
clinical-stage pharmaceutical company developing a new generation of
multi-mechanism drugs for the treatment of cancer and inflammatory diseases.
Currently, we are focused on developing our primary program, ENMD-2076, an
Aurora A and angiogenic kinase inhibitor for the treatment of cancer. ENMD-2076
has completed Phase 1 studies in advanced cancers and multiple myeloma and
commenced Phase II studies in ovarian cancer in April 2010. Our other
therapeutic candidates include MKC-1, an oral cell-cycle inhibitor with activity
against the mTOR pathway currently in multiple Phase 2 clinical trials for
cancer, and ENMD-1198, a novel antimitotic agent currently in Phase 1 studies in
advanced cancers. The U.S. Food and Drug Administration (the FDA) has
approved our Investigational New Drug Application (IND) for the use of Panzem
â
in rheumatoid
arthritis (RA) treatment. All of our candidates are multi-mechanism drugs that
target disease cells and the blood vessels that nourish them, which we believe
can be developed to be safe and convenient, and provide the potential for
improved patient outcomes.
Our
principal offices are located at 9640 Medical Center Drive, Rockville, Maryland
20850, and our telephone number is (240) 864-2600. Additional information
concerning us can be found in our periodic filings with the Securities and
Exchange Commission, or the SEC, which are available on our website at
www.entremed.com and on the SEC’s website at www.sec.gov. The information on our
web site is not deemed to be part of this prospectus.
RISK
FACTORS
An
investment in our securities involves significant risk. You should consider
carefully the risks and uncertainties described below together with all other
information in our filings with the Securities and Exchange Commission (the
“SEC”) that are contained or incorporated by reference in this prospectus
supplement and the accompanying prospectus before you decide to invest in our
securities. The risk factors set forth below, in addition to all such other
information that is contained or incorporated by reference in this prospectus
supplement and the accompanying prospectus supersede the risk factors contained
in our prior filings with the SEC. Prospective investors should review all of
these risk factors before making an investment decision. If any of these risks
or uncertainties actually occurs, our business, financial condition or results
of operations could be materially adversely affected. Additional risks and
uncertainties of which we are unaware or that we currently believe are
immaterial could also materially adversely affect our business, financial
condition or results of operations. In any case, the trading price of our common
stock could decline, and you could lose all or part of your investment. See also
“Special Note Regarding Forward-Looking Statements.”
We
Have an Immediate Need for Capital and Will Need to Raise Additional Capital in
the Future to Continue our Business, and Our Former Independent Registered
Public Accounting Firm Expressed Substantial Doubt as to our Ability to Continue
as a Going Concern
We
estimate that our current capital resources will not be sufficient to fund our
operations significantly beyond December 2010 without an additional curtailment
of operating expenditures or new equity or debt financing. In addition, our
financial statements for the fiscal year ending December 31, 2009 were prepared
on the assumption that we will continue as a going concern, which contemplates
the realization of assets and liquidation of liabilities in the normal course of
business. However, the independent registered public accounting firm that
prepared the report on our financial statements as of and for the fiscal year
ended December 31, 2009, included an explanatory paragraph that states that
our recurring losses from operations raise substantial doubt about our ability
to continue as a going concern.
Our
ability to continue as a going concern is dependent on our success at raising
additional capital sufficient to meet our obligations on a timely basis and to
ultimately attain profitability. In the event we are unable to successfully
raise additional capital, it is unlikely that we will have sufficient cash flows
and liquidity to finance our business operations as currently contemplated.
Accordingly, in the event new financing is not obtained, we will likely reduce
general and administrative expenses and delay clinical development activity
until we are able to obtain sufficient financing to do so. These factors could
significantly limit our ability to continue as a going concern.
We
Have a History of Losses and Anticipate Future Losses
To date,
we have been engaged primarily in research and development activities. Although
we receive limited revenues on royalties from sales of Thalomid
®
and in
the past have received license fees and research and development funding from a
former collaborator and limited revenues from certain research grants, we have
not derived significant revenues from operations.
We have
experienced losses in each year since inception. Through March 31,
2010, we had an accumulated deficit of approximately $368
million. We expect that it will be very difficult to raise
capital to continue our operations and our independent registered public
accounting firm for the fiscal year ended December 31, 2009 issued an opinion
with an explanatory paragraph to its report on the financial statements for the
year ended December 31, 2009 to the effect that there is substantial doubt about
our ability to continue as a going concern. Although we have been
successfully funded to date by attracting investors in our equity securities and
through royalty payments, there is no assurance that our capital-raising efforts
will be able to attract the capital needed to sustain our operations beyond that
date or that such royalty payments will continue to provide revenues at
historical levels. If we are unable to obtain additional funding for
operations, we may not be able to continue operations as proposed, requiring us
to modify our business plan, curtail various aspects of our operations or cease
operations. In such event, investors may lose a portion or all of their
investment.
Losses
have continued since December 31, 2009. We will also be required to
conduct substantial research and development and clinical testing activities for
ENMD-2076. We expect that these activities will result in operating losses for
the foreseeable future before we commercialize any products, if
ever. In addition, to the extent we rely on others to develop and
commercialize our products, our ability to achieve profitability will depend
upon the success of these other parties. To support our research and
development of certain product candidates, we may seek and rely on cooperative
agreements from governmental and other organizations as a source of support. If
a cooperative agreement were to be reduced to any substantial extent, it may
impair our ability to continue our research and development
efforts. Even if we do achieve profitability, we may be unable to
sustain or increase it.
Our
Common Stock May be Delisted From The NASDAQ Capital Market, Which Could
Negatively Impact the Price of Our Common Stock and Our Ability to Access the
Capital Markets
NASDAQ
Minimum $1.00 Closing Bid Price
On
April 4, 2008, we received a letter from The NASDAQ Stock Market LLC
(“NASDAQ”) advising that for the previous 30 consecutive business days, the bid
price of the Company’s common stock had closed below the minimum $1.00 per share
requirement for continued inclusion on The NASDAQ Global Market. The
letter also advised us that failure to comply with this minimum bid price
requirement, or any other listing standard applicable to issuers listed on The
NASDAQ Global Market, by October 1, 2008, would result in our common stock
being ineligible for quotation on The NASDAQ Global Market. Our stock price has
not closed above $1.00 for ten consecutive trading days since the date of the
receipt of the letter from NASDAQ.
On
September 22, 2008, we submitted an application to transfer the trading of
our common stock to The NASDAQ Capital Market. On October 1, 2008, we
received a letter from The NASDAQ Listing Qualifications Department stating that
our application had been approved and that our common stock would commence
trading on The NASDAQ Capital Market on October 3, 2008. The NASDAQ Capital
Market operates in substantially the same manner as The NASDAQ Global Market.
Our trading symbol remains as “ENMD” and the trading of our stock was unaffected
by the transfer.
NASDAQ
suspended the enforcement of the minimum bid price rule, because of the current
extraordinary market conditions, until July 31, 2009. Upon
reinstatement of the rule on August 3, 2009, under NASDAQ rules, we had
until January 15, 2010, to regain compliance with the minimum bid price
standard. We did not regain compliance with the minimum bid price
standard of the NASDAQ rules by January 15, 2010.
On
January 19, 2010, we received a Staff Determination letter from NASDAQ stating
that we were not in compliance with the continued listing rules and that our
Common Stock would be delisted unless we requested an appeal of such
determination. On January 20, 2010, we filed an appeal of the
Staff's determination to a NASDAQ Hearings Panel (the “Panel”), pursuant to the
procedures set forth in the NASDAQ Marketplace Rules. The hearing request
stayed the delisting of the Company’s securities pending the Panel's
decision. On February 25, 2010, we met with the Panel providing them
a plan of action, with the intention of returning to compliance with NASDAQ’s
requirements. On March 23, 2010, we received a decision letter from
the Panel granting our request to extend the compliance date for an additional
180 days or until July 16, 2010. As a result of this decision by the
Panel, our stock will continue to trade on The Nasdaq Capital Market until such
date, by which time our minimum bid price must have exceeded $1.00 for ten
consecutive trading days.
In the
event that our common stock continues to trade under $1.00, we will consider all
alternatives in order to maintain the public trading status of our stock,
including electing to implement a reverse stock split with the approval of our
stockholders.
An alternative to not
having to meet both the NASDAQ $1.00 minimum closing bid price and the $2.5
million stockholders’ equity is to apply to have our common stock traded on the
Over-The-Counter Bulletin Board (the “OTCBB”), an electronic quotation system
that displays stock quotes by market makers. If such course of action
is taken, there can be no assurance that our common stock would be timely
admitted for trading on that market. This alternative may result in a
less liquid market available for existing and potential shareholders to buy and
sell shares of our common stock and could further depress the price of our
stock.
The
delisting of our common stock from a national exchange could significantly
affect the ability of investors to trade our securities and could negatively
affect the value and liquidity of our common stock. Delisting could also have
other negative results, including the potential loss of confidence by employees,
the loss of institutional investor interest and fewer business development
opportunities. In addition, the delisting of our common stock could materially
adversely affect our ability to raise capital on terms acceptable to us or at
all.
NASDAQ
Minimum $2.5 Million Stockholders’ Equity
Additionally,
we must continually maintain (1) stockholders’ equity of at least $2.5 million
or (2) a minimum of $35 million in market value of our listed securities for ten
consecutive trading days to be in compliance with the continued listing
standards for The NASDAQ Capital Market. At December 31, 2009, our
consolidated stockholders’ deficit was approximately $1.9 million and the market
value of our listed securities was $70.9 million. There can be no
assurance that we will be able to meet either of these listing standards in the
future. If we do not meet one of these NASDAQ listing requirements,
we will be in a deficiency period and will submit a plan of compliance with
NASDAQ. After the deficiency period, if we are unable to successfully
appeal to the NASDAQ Panel for an extension of time to regain compliance, our
common stock could be delisted from The NASDAQ Capital Market.
The
Current Capital and Credit Market Conditions May Adversely Affect the Company’s
Access to Capital, Cost of Capital, and Ability to Execute its Business Plan as
Scheduled
Access to
capital markets is critical to our ability to operate. Traditionally,
biopharmaceutical companies (such as we) have funded their research and
development expenditures through raising capital in the equity
markets. Declines and uncertainties in these markets over the past
two years have severely restricted raising new capital and have affected our
ability to continue to expand or fund existing research and development efforts.
We require significant capital for research and development for our product
candidates and clinical trials. In recent years, the general economic and
capital market conditions in the United States have deteriorated significantly
and have adversely affected our access to capital and increased the cost of
capital, and there is no certainty that a recovery in the capital and credit
markets, enabling us to raise capital in an amount to sufficiently fund our
short-term and long-term plans, will occur in 2010. If these economic
conditions continue or become worse, our future cost of equity or debt capital
and access to the capital markets could be adversely affected. In addition, our
inability to access the capital markets on favorable terms because of our low
stock price, or upon our delisting from the NASDAQ Capital Market if we fail to
satisfy a listing requirement, could affect our ability to execute our business
plan as scheduled. Moreover, we rely and intend to rely on third
parties, including our clinical research organizations, third party
manufacturers, and certain other important vendors and consultants. As a result
of the current volatile and unpredictable global economic situation, there may
be a disruption or delay in the performance of our third-party contractors and
suppliers. If such third parties are unable to adequately satisfy their
contractual commitments to us in a timely manner, our business could be
adversely affected.
We
are Uncertain Whether Additional Funding Will Be Available For Our Future
Capital Needs and Commitments, and If We Cannot Raise Additional Funding, or
Access the Credit Markets, We May Be Unable to Complete Development of Our
Product Candidates
We will
require substantial funds in addition to our existing working capital to develop
our product candidates and otherwise to meet our business objectives. We have
never generated sufficient revenue during any period since our inception to
cover our expenses and have spent, and expect to continue to spend, substantial
funds to continue our research and development and clinical programs. Any one of
the following factors, among others, could cause us to require additional funds
or otherwise cause our cash requirements in the future to increase
materially:
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results of research and
development activities;
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progress of our preclinical
studies or clinical trials;
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results of clinical
trials;
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changes in or terminations of our
relationships with strategic
partners;
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changes in the focus, direction,
or costs of our research and development
programs;
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competitive and technological
advances;
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establishment of marketing and
sales capabilities;
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the regulatory approval process;
or
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At March
31, 2010, we had cash, cash equivalents and short-term investments of
approximately $9.7 million. During the second quarter of 2010,
we raised an additional $3 million, which resulted in net proceeds to us of
approximately $2.8 million. Except for the offering contemplated
under this prospectus supplement, we currently have no commitments or
arrangements for any financing. We may continue to seek additional
capital through public or private financing or collaborative agreements. Our
operations require significant amounts of cash. We may be required to
seek additional capital, whether from sales of equity or debt or additional
borrowings, for the future growth and development of our business. We can give
no assurance as to the availability of such additional capital or, if available,
whether it would be on terms acceptable to us. In addition, we may continue to
seek capital through the public or private sale of securities, if market
conditions are favorable for doing so. If we are successful in raising
additional funds through the issuance of equity securities, stockholders will
likely experience substantial dilution, or the equity securities may have
rights, preferences, or privileges senior to those of the holders of our common
stock. If we raise funds through the issuance of debt securities, those
securities would have rights, preferences, and privileges senior to those of our
common stock. The current credit environment has negatively affected the
economy, and we have considered how it might affect our business. Events
affecting credit market liquidity could increase borrowing costs or limit
availability of funds, and due to the continued adverse trends in the credit
market, it may not be possible to refinance our existing credit facility to take
advantage of lower interest rates. Moreover, the covenants of our term loan
agreement contain provisions that may restrict the debt we may incur in the
future. If we are not successful in obtaining sufficient capital because we are
unable to access the capital markets at financially economical interest rates,
it could reduce our research and development efforts and may materially
adversely affect our future growth, results of operations and financial results,
and we may be required to curtail significantly, or eliminate at least
temporarily, one or more of our drug development programs.
We Rely Exclusively on the Royalty
Payments Based upon Thalomid
®
Sales by a Third Party to Produce our
Revenues
We
entered into a licensing agreement in 2001 regarding royalty payments for
Thalomid®, and in 2004, certain provisions of that agreement were satisfied,
which then entitled the Company to share in royalty payments received by Royalty
Pharma Finance Trust on annual Thalomid® sales above a certain threshold. Based
on the licensing agreement royalty formula, annual royalty sharing commences
with Thalomid® annual sales of approximately $225 million. During the year
ended December 31, 2009, royalty payments from Thalomid® sales by Celgene
Corporation accounted for substantially all of our total revenues. As
Thalomid® is distributed and sold by Celgene and/or its affiliates, we are
reliant on a third party for our revenues. Our royalty payments in
the third and fourth quarters of 2009 experienced a decline as compared to the
same periods in 2008, and our total Thalomid® royalty revenues earned in fiscal
2009 were lower than fiscal 2008. No royalties were
earned during the first or second quarter of fiscal 2010. A wide
variety of events could cause Thalomid
®
sales to
decline, resulting in a material reduction in our revenues. For
example, if a competing drug gains greater market share or wider acceptance, or
if regulatory approvals for certain uses of Thalomid® are withdrawn, such events
could adversely affect our royalty revenue. In the event that Celgene
determines to cease selling Thalomid®or target its sales efforts to other
proprietary drugs, or unexpected adverse effects are reported by patients or
doctors in connection with the use of Thalomid®, patient and physician
confidence in Thalomid® as a treatment could be adversely affected. The
inability of one of these third parties to perform these functions, or the
failure of any of these parties to perform successfully, could cause our
revenues to suffer. Additionally, if a competitor to Celgene successfully
introduces a generic pharmaceutical product equivalent to Thalomid® at a
relatively lower price and bypasses Celgene’s S.T.E.P.S.
®
proprietary distribution program, such action could have the effect of reducing
the market share and profitability of Thalomid®, thus potentially causing a
material adverse effect on our revenues and cash flow. Because we are dependent
on sales of Thalomid® any reduction in Thalomid® sales for any reason,
including, but not limited to, the reasons described, would cause our results of
operations to suffer.
The
Market Price of Our Common Stock May Be Highly Volatile or May Decline
Regardless of Our Operating Performance
Our
common stock price has fluctuated from year-to-year and quarter-to-quarter and
will likely continue to be volatile. Our stock has not traded at the
minimum closing bid price of $1.00 for a period of ten or more days in the past
twelve months. The valuations of many biotechnology companies without
consistent product revenues and earnings are extraordinarily high based on
conventional valuation standards, such as price to earnings and price to sales
ratios. These trading prices and valuations may not be sustained. In the future,
our operating results in a particular period may not meet the expectations of
any securities analysts whose attention we may attract, or those of our
investors, which may result in a decline in the market price of our common
stock. Any negative change in the public’s perception of the prospects of
biotechnology companies could depress our stock price regardless of our results
of operations. These factors may materially and adversely affect the market
price of our common stock.
Our
Existing Term Loan Contains Affirmative and Negative Covenants That May Restrict
our Business and Financing Activities
We
entered into a $20 million loan agreement with General Electric Capital
Corporation, as agent for the lenders party thereto, on September 12,
2007. The loan agreement is secured by a pledge of all of our assets
other than intellectual property, including the shares of the outstanding
capital stock, or other equity interests, of each of our subsidiaries, and
contains a variety of operational covenants, including limitations on our
ability to incur liens or additional debt, make dispositions, pay dividends,
redeem our stock, make certain investments and engage in certain merger,
consolidation or asset sale transactions and transactions with affiliates, among
other restrictions. Any future debt financing we enter into may involve similar
or more onerous covenants that restrict our operations. Our borrowings under the
loan agreement or any future debt financing we do will need to be repaid, which
creates additional financial risk for our company, particularly if our business,
or prevailing financial market conditions, are not conducive to paying-off or
refinancing our outstanding debt obligations. Furthermore, our failure to comply
with the covenants in the loan agreement could result in an event of default
that, if not cured or waived, could result in the acceleration of all or a
substantial portion of our debt, which could have a material adverse effect on
our cash position, business, prospects, financial condition and results of
operations. Our final scheduled payment under the loan agreement is
in January 2011.
Our
Secured Lender and Preferred Stockholder Would Have Priority in Distributions
Over our Common Stockholders Following a Liquidation Event Affecting the
Company. As a Result, in the Event of a Liquidation Event, our Common
Stockholders Would Receive Distributions Only After Priority Distributions Are
Paid
In the
event of a Liquidation Event (as such term is defined in our Certificate of
Designation of Series A Convertible Preferred Stock), our senior lender would be
repaid first out of the proceeds received. Celgene, the sole holder of our
outstanding Series A Convertible Preferred Stock (“Series A
Preferred”), then would be paid an amount equal to the Series A Preferred
liquidation preference of $10.00 per share of Series A Preferred, plus all
accrued and unpaid dividends on such shares of Series A Preferred, which
totals approximately $7 million as of December 31,
2009. Additionally, unless waived, the holder of the Series A
Preferred would be entitled to receive the Series A liquidation preference
plus all accrued and unpaid dividends prior to any distributions to our common
stockholders upon the occurrence of certain other liquidation
events. As a result, in the event of a Liquidation Event, our common
stockholders’ ability to realize value for their shares would be subject to the
payment of such priority distributions.
Development
of Our Products is at an Early Stage and is Uncertain
Our
proposed products and research programs are in the early stage of clinical
development and require significant, time-consuming and costly research and
development, testing and regulatory clearances. In developing our products, we
are subject to risks of failure that are inherent in the development of these
products and therapeutic procedures. For example, it is possible that any or all
of our proposed products will be ineffective or toxic, or otherwise will fail to
receive necessary FDA clearances. There is a risk that the proposed products
will be uneconomical to manufacture or market or will not achieve market
acceptance. There is also a risk that third parties may hold proprietary rights
that preclude us from marketing our proposed products or that others will market
a superior or equivalent product. Further, our research and development
activities might never result in commercially viable products.
A number
of companies in the pharmaceutical and biotechnology industries have suffered
significant setbacks in advanced clinical trials even after promising results in
earlier trials.
In
particular, given the current conditions in the financial markets, an
unfavorable outcome in our Phase 2 trials for ENMD 2076, or a significant delay
in initiating such trials, may require us to delay, reduce the scope of, or
eliminate this program and could have a material adverse effect on our company
and the value of our common stock.
Once a
clinical trial has begun, it may be delayed, suspended or terminated due to a
number of factors, including:
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ongoing discussions with
regulatory authorities regarding the scope or design of our clinical
trials or requests by them for supplemental information with respect to
our clinical trial results;
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failure to conduct clinical
trials in accordance with regulatory
requirements;
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lower than anticipated retention
rate of patients in clinical
trials;
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serious adverse events or side
effects experienced by participants;
and
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insufficient supply or deficient
quality of product candidates or other materials necessary for the conduct
of our clinical trials.
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Many of
these factors may also ultimately lead to denial of regulatory approval of a
current or potential product candidate. If we experience delays,
suspensions or terminations in a clinical trial, the commercial prospects for
the related product candidate will be harmed, and our ability to generate
product revenues will be delayed.
Our
product candidates are at the clinical stage of development. Although several of
our product candidates have demonstrated some promising results in early
clinical (human) trials and preclinical (animal) studies, they may not
prove to be effective in humans. For example, testing on animals may occur under
different conditions than testing in humans and therefore the results of animal
studies may not accurately predict human experience. Likewise, early clinical
studies may not be predictive of eventual safety or effectiveness results in
larger-scale pivotal clinical trials.
There are
many regulatory steps that must be taken before any of these product candidates
will be eligible for FDA approval and subsequent sale, including the completion
of preclinical and clinical trials. We do not expect that these product
candidates will be commercially available for several years, if
ever.
Technological
Developments By Competitors May Render Our Products Obsolete
If
competitors were to develop superior technologies, our technologies could be
rendered noncompetitive or obsolete, resulting in a material adverse effect to
our business. Developments in the biotechnology and pharmaceutical industries
are expected to continue at a rapid pace. Success depends upon achieving and
maintaining a competitive position in the development of products and
technologies. Competition from other biotechnology and pharmaceutical companies
can be intense. Many competitors have substantially greater research and
development capabilities, marketing, financial and managerial resources and
experience in the industry. Even if a competitor creates a technology that is
not superior, we may not be able to compete with such technology.
We
Must Show the Safety and Efficacy of Our Product Candidates Through Clinical
Trials, the Results of Which are Uncertain
Before
obtaining regulatory approvals for the commercial sale of our products, we must
demonstrate, through preclinical studies (animal testing) and clinical trials
(human testing), that our proposed products are safe and effective for use in
each target indication. Testing of our product candidates will be required, and
failure can occur at any stage of testing. Clinical trials may not demonstrate
sufficient safety and efficacy to obtain the required regulatory approvals or
result in marketable products. The failure to adequately demonstrate the safety
and efficacy of a product under development could delay or prevent regulatory
approval of the potential product.
Clinical
trials for the product candidates we are developing may be delayed by many
factors, including that potential patients for testing are limited in number.
The failure of any clinical trials to meet applicable regulatory standards could
cause such trials to be delayed or terminated, which could further delay the
commercialization of any of our product candidates. Newly emerging safety risks
observed in animal or human studies also can result in delays of ongoing or
proposed clinical trials. Any such delays will increase our product development
costs. If such delays are significant, they could negatively affect our
financial results and the commercial prospects for our products.
The
Independent Clinical Investigators and Contract Research Organizations That We
Rely Upon to Assist in the Conduct of Our Clinical Trials May Not Be Diligent,
Careful or Timely, and May Make Mistakes, in the Conduct of Our
Trials
We depend
on independent clinical investigators and contract research organizations, or
CROs, to assist in the conduct of our clinical trials under their agreements
with us. The investigators are not our employees, and we cannot control the
amount or timing of resources that they devote to our programs. If independent
investigators fail to devote sufficient time and resources to our drug
development programs, or if their performance is substandard, it will delay the
approval of our FDA applications and our introduction of new drugs. The CROs we
contract with to assist with the execution of our clinical trials play a
significant role in the conduct of the trials and the subsequent collection and
analysis of data. Failure of the CROs to meet their obligations could adversely
affect clinical development of our products.
The
Success of Our Business Depends Upon the Members of Our Senior Management Team,
Our Scientific Staff and Our Ability to Continue to Attract and Retain Qualified
Scientific, Technical and Business Personnel
We are
dependent on the principal members of our reconstituted senior management team
and scientific staff for our business success. The loss of any of these people
could impede the achievement of our development and business objectives. We do
not carry key man life insurance on the lives of any of our key personnel. There
is intense competition for human resources, including management, in the
scientific fields in which we operate and there can be no assurance that we will
be able to attract and retain qualified personnel necessary for the successful
development of ENMD-2076, and any expansion into areas and activities requiring
additional expertise. In addition, there can be no assurance that such personnel
or resources will be available when needed. In addition, we rely on a
significant number of consultants to assist us in formulating our clinical
strategy and other business activities. All of our consultants may have
commitments to, or advisory or consulting agreements with, other entities that
may limit their availability to us.
We
May Need New Collaborative Partners to Further Develop and Commercialize
Products, and if We Enter Into Such Arrangements, We May Give Up Control Over
the Development and Approval Process and Decrease our Potential
Revenue
We plan
to develop and commercialize our product candidates both with and without
corporate alliances and partners. Nonetheless, we intend to explore
opportunities for new corporate alliances and partners to help us develop,
commercialize and market our product candidates. We expect to grant to our
partners certain rights to commercialize any products developed under these
agreements, and we may rely on our partners to conduct research and development
efforts and clinical trials on, obtain regulatory approvals for, and manufacture
and market any products licensed to them. Each individual partner will seek to
control the amount and timing of resources devoted to these activities
generally. We anticipate obtaining revenues from our strategic partners under
such relationships in the form of research and development payments and payments
upon achievement of certain milestones. Since we generally expect to obtain a
royalty for sales or a percentage of profits of products licensed to third
parties, our revenues may be less than if we retained all commercialization
rights and marketed products directly. In addition, there is a risk that our
corporate partners will pursue alternative technologies or develop competitive
products as a means for developing treatments for the diseases targeted by our
programs.
We may
not be successful in establishing any collaborative arrangements. Even if we do
establish such collaborations, we may not successfully commercialize any
products under or derive any revenues from these arrangements. Our strategy also
involves entering into multiple, concurrent strategic alliances to pursue
commercialization of our core technologies. There is a risk that we will be
unable to manage simultaneous programs successfully. With respect to existing
and potential future strategic alliances and collaborative arrangements, we will
depend on the expertise and dedication of sufficient resources by these outside
parties to develop, manufacture, or market products. If a strategic alliance or
collaborative partner fails to develop or commercialize a product to which it
has rights, we may not recognize any revenues on that particular
product.
We Have No Current Manufacturing or
Marketing Capacity and Rely on Only One Supplier For Some of Our
Products
We do not
expect to manufacture or market products in the near term, but we may try to do
so in certain cases. We do not currently have the capacity to manufacture or
market products and we have limited experience in these activities. The
manufacturing processes for all of the small molecules we are developing have
not yet been tested at commercial levels, and it may not be possible to
manufacture these materials in a cost-effective manner. If we elect
to perform these functions, we will be required to either develop these
capacities, or contract with others to perform some or all of these tasks. We
may be dependent to a significant extent on corporate partners, licensees, or
other entities for manufacturing and marketing of products. If we engage
directly in manufacturing or marketing, we will require substantial additional
funds and personnel and will be required to comply with extensive regulations.
We may be unable to develop or contract for these capacities when required to do
so in connection with our business.
We depend
on our third-party manufacturers to perform their obligations effectively and on
a timely basis. These third parties may not meet their obligations and any such
non-performance may delay clinical development or submission of products for
regulatory approval, or otherwise impair our competitive position. Any
significant problem experienced by one of our suppliers could result in a delay
or interruption in the supply of materials to us until such supplier resolves
the problem or an alternative source of supply is located. Any delay or
interruption would likely lead to a delay or interruption of manufacturing
operations, which could negatively affect our operations. Although we have
identified alternative suppliers for our product candidates, we have not entered
into contractual or other arrangements with them. If we needed to use an
alternate supplier for any product, we would experience delays while we
negotiated an agreement with them for the manufacture of such product. In
addition, we may be unable to negotiate manufacturing terms with a new supplier
as favorable as the terms we have with our current suppliers.
Problems
with any manufacturing processes could result in product defects, which could
require us to delay shipment of products or recall products previously shipped.
In addition, any prolonged interruption in the operations of the manufacturing
facilities of one of our sole-source suppliers could result in the cancellation
of shipments. A number of factors could cause interruptions, including equipment
malfunctions or failures, or damage to a facility due to natural disasters or
otherwise. Because our manufacturing processes are or are expected to be highly
complex and subject to a lengthy FDA approval process, alternative qualified
production capacity may not be available on a timely basis or at all.
Difficulties or delays in our manufacturing could increase our costs and damage
our reputation.
The
manufacture of pharmaceutical products can be an expensive, time consuming, and
complex process. Manufacturers often encounter difficulties in scaling-up
production of new products, including quality control and assurance and
shortages of personnel. Delays in formulation and scale-up to commercial
quantities could result in additional expense and delays in our clinical trials,
regulatory submissions, and commercialization.
Failure
of Manufacturing Facilities Producing Our Product Candidates to Maintain
Regulatory Approval Could Delay or Otherwise Hinder Our Ability to Market Our
Product Candidates
Any
manufacturer of our product candidates will be subject to applicable Good
Manufacturing Practices (GMP) prescribed by the FDA or other rules and
regulations prescribed by foreign regulatory authorities. We and any of our
collaborators may be unable to enter into or maintain relationships either
domestically or abroad with manufacturers whose facilities and procedures comply
or will continue to comply with GMP and who are able to produce our small
molecules in accordance with applicable regulatory standards. Failure by a
manufacturer of our products to comply with GMP could result in significant time
delays or our inability to obtain marketing approval or, should we have market
approval, for such approval to continue. Changes in our manufacturers could
require new product testing and facility compliance inspections. In the United
States, failure to comply with GMP or other applicable legal requirements can
lead to federal seizure of violated products, injunctive actions brought by the
federal government, inability to export product, and potential criminal and
civil liability on the part of a company and its officers and
employees.
We
Depend on Patents and Other Proprietary Rights, Some of Which are
Uncertain
Our
success will depend in part on our ability to obtain patents for our products,
both in the United States and abroad. The patent position of biotechnology and
pharmaceutical companies in general is highly uncertain and involves complex
legal and factual questions. Risks that relate to patenting our products include
the following:
|
·
|
our failure to obtain additional
patents;
|
|
·
|
challenge, invalidation, or
circumvention of patents already issued to
us;
|
|
·
|
failure of the rights granted
under our patents to provide sufficient
protection;
|
|
·
|
independent development of
similar products by third parties;
or
|
|
·
|
ability of third parties to
design around patents issued to our collaborators or
us.
|
Our
potential products may conflict with composition, method, and use of patents
that have been or may be granted to competitors, universities or others. As the
biotechnology industry expands and more patents are issued, the risk increases
that our potential products may give rise to claims that may infringe the
patents of others. Such other persons could bring legal actions against us
claiming damages and seeking to enjoin clinical testing, manufacturing and
marketing of the affected products. Any such litigation could result in
substantial cost to us and diversion of effort by our management and technical
personnel. If any of these actions are successful, in addition to any potential
liability for damages, we could be required to obtain a license in order to
continue to manufacture or market the affected products. We may not prevail in
any action and any license required under any needed patent might not be made
available on acceptable terms, if at all.
We are a
party to license agreements that require us to make milestone payments upon
attainment of certain regulatory milestones. Failure to meet such milestones
could result in the loss of certain rights to compounds covered under such
license agreements.
We also
rely on trade secret protection for our confidential and proprietary
information. However, trade secrets are difficult to protect and others may
independently develop substantially equivalent proprietary information and
techniques and gain access to our trade secrets and disclose our technology. We
may be unable to meaningfully protect our rights to unpatented trade secrets. We
require our employees to complete confidentiality training that specifically
addresses trade secrets. All employees, consultants, and advisors are required
to execute a confidentiality agreement when beginning an employment or a
consulting relationship with us. The agreements generally provide that all trade
secrets and inventions conceived by the individual and all confidential
information developed or made known to the individual during the term of the
relationship automatically become our exclusive property. Employees and
consultants must keep such information confidential and may not disclose such
information to third parties except in specified circumstances. However, these
agreements may not provide meaningful protection for our proprietary information
in the event of unauthorized use or disclosure of such
information.
To the
extent that consultants, key employees, or other third parties apply
technological information independently developed by them or by others to our
proposed projects, disputes may arise as to the proprietary rights to such
information. Any such disputes may not be resolved in our favor. Certain of our
consultants are employed by or have consulting agreements with other companies
and any inventions discovered by them generally will not become our
property.
Our
Potential Products Are Subject to Government Regulatory Requirements and an
Extensive Approval Process
Our
research, development, preclinical and clinical trials, manufacturing, and
marketing of most of our product candidates are subject to an extensive
regulatory approval process by the FDA and other regulatory agencies in the
United States and abroad. The process of obtaining FDA and other required
regulatory approvals for drug and biologic products, including required
preclinical and clinical testing, is time consuming and expensive. Even after
spending time and money, we may not receive regulatory approvals for clinical
testing or for the manufacturing or marketing of any products. Our collaborators
or we may encounter significant delays or costs in the effort to secure
necessary approvals or licenses. Even if we obtain regulatory clearance for a
product, that product will be subject to continuing review. Later discovery of
previously unknown defects or failure to comply with the applicable regulatory
requirements may result in restrictions on a product’s marketing or withdrawal
of the product from the market, as well as possible civil or criminal
penalties.
Potential
Products May Subject Us to Product Liability for Which Insurance May Not Be
Available
The use
of our potential products in clinical trials and the marketing of any
pharmaceutical products may expose us to product liability claims. We have
obtained a level of liability insurance coverage that we believe is adequate in
scope and coverage for our current stage of development. However, our present
insurance coverage may not be adequate to protect us from liabilities we might
incur. In addition, our existing coverage will not be adequate as we further
develop products and, in the future, adequate insurance coverage and
indemnification by collaborative partners may not be available in sufficient
amounts or at a reasonable cost. If a product liability claim or series of
claims are brought against us for uninsured liabilities, or in excess of our
insurance coverage, the payment of such liabilities could have a negative effect
on our business and financial condition.
We
Acquired Miikana in 2006 in a Strategic Transaction and May Engage in Other
Strategic Transactions, Which Could Negatively Affect Our Business and
Earnings
In
January 2006, we acquired Miikana Therapeutics, Inc., a clinical-stage
biopharmaceutical company. In 2010, we may consider strategic
and other corporate transactions as opportunities present
themselves. There are risks associated with such activities. These
risks include, among others, incorrectly assessing the quality of a prospective
strategic partner, encountering greater than anticipated costs in integration,
being unable to profitably deploy assets acquired in the transaction, such as
drug candidates, possible dilution to our stockholders, and the loss of key
employees due to changes in management. Further, strategic transactions may
place additional constraints on our resources by diverting the attention of our
management from our business operations. Our newly constituted senior management
team does not have substantial experience with acquisitions. To the extent we
issue securities in connection with additional transactions, these transactions
and related issuances may have a dilutive effect on earnings per share and our
ownership. Our earnings, financial condition, and prospects after an acquisition
depend in part on our ability to successfully integrate the operations of the
acquired business or technologies. We may be unable to integrate operations
successfully or to achieve expected cost savings. Any cost savings which are
realized may be offset by losses in revenues or other charges to
earnings.
Risks
Related to our Common Stock
The
Price of our Common Stock has Been and is Likely to Continue to be Volatile, and
Your Investment Could Suffer a Decline in Value
Market
prices for our common stock and the securities of certain other biotechnology
and biopharmaceutical companies have been highly volatile and may continue to be
highly volatile in the future. Our common stock has been, and is likely to be,
highly volatile and could be subject to wide fluctuations in price in response
to various factors, many of which are beyond our control,
including:
|
·
|
the timing and the results from
our clinical trial programs;
|
|
·
|
FDA or other federal or state
regulatory actions;
|
|
·
|
failure of any of our product
candidates, if approved, to achieve commercial
success;
|
|
·
|
announcements of clinical trial
results or new product introductions by our
competitors;
|
|
·
|
market conditions in the
pharmaceutical, biopharmaceutical and biotechnology
sectors;
|
|
·
|
developments concerning our or
our competitors’ intellectual property
rights;
|
|
·
|
litigation or public concern
about the safety of our product
candidates;
|
|
·
|
deviations in our business and
the trading price of our common stock from the estimates of securities
analysts; and
|
|
·
|
additions or departures of key
personnel.
|
Moreover,
the stock market in general may experience extreme price and volume fluctuations
that are unrelated and disproportionate to the operating performance of
companies. As a result of such volatility, you could lose all or part of your
investment. Class action litigation has often been instituted against
companies whose securities have experienced periods of volatility in market
price. Any such litigation brought against us could result in substantial costs
and a diversion of management’s attention and resources, which could hurt our
business, operating results and financial condition.
We
May Require Additional Capital in the Future, Which May Not be Available to Us
on Favorable Terms. Issuances of our Equity Securities to Provide This Capital
May Dilute Your Ownership in Us
We may
need to raise additional funds through public or private debt or equity
financings in order to:
|
·
|
take advantage of expansion
opportunities;
|
|
·
|
acquire complementary businesses
or technologies;
|
|
·
|
develop new services and
products; or
|
|
·
|
respond to competitive
pressures.
|
Any
additional capital raised through the issuance of our equity securities may
dilute your percentage ownership interest in us. Furthermore, any additional
financing we may need may not be available on terms favorable to us or at all.
The unavailability of needed financing could adversely affect our ability to
execute our growth strategy.
Sales
of Substantial Amounts of our Common Stock or the Perception That Such Sales May
Occur Could Cause the Market Price of Our Common Stock to Drop Significantly,
Even if Our Business is Performing Well
The
market price of our common stock could decline as a result of sales by, or the
perceived possibility of sales by, our existing stockholders of shares of our
common stock in the market after this offering. These sales
might also make it more difficult for us to sell equity securities at a time and
price that we deem appropriate, or at all. In addition, we have filed resale
shelf registration statements to register shares of our common stock that may be
sold by certain of our stockholders, which may increase the likelihood of sales,
or the perception of an increased likelihood of sales, by our existing
stockholders of shares of our common stock.
Because
We Do Not Expect to Pay Dividends in the Foreseeable Future, You Must Rely on
the Possibility of Stock Appreciation for any Return on Your
Investment
We have
paid no cash dividends on any of our capital stock to date, and we currently
intend to retain our future earnings, if any, to fund the development and growth
of our business. As a result, we do not expect to pay any cash dividends in the
foreseeable future, and payment of cash dividends, if any, will also depend on
our financial condition, results of operations, capital requirements and other
factors and will be at the discretion of our board of directors. Furthermore, we
are subject to various laws and regulations that may restrict our ability to pay
dividends and we may in the future become subject to contractual restrictions
on, or prohibitions against, the payment of dividends. Accordingly, the success
of your investment in our common stock will likely depend entirely upon any
future appreciation. There is no guarantee that our common stock will appreciate
in value after the offering or even maintain the price at which you purchased
your shares, therefore, you may not realize a return on your investment in our
common stock and you may lose your entire investment in our common
stock.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus contains and incorporates by reference certain forward-looking
statements within the meaning of the Private Securities Litigation Reform Act of
1995. All statements that are not descriptions of historical facts are
forward-looking statements. These statements can generally be identified by the
use of forward-looking terminology such as “believes,” “expects,” “intends,”
“may,” “will,” “should,” or “anticipates” or similar terminology. These
forward-looking statements include, among others, statements regarding the
timing of our clinical trials, our cash position and future expenses, and our
future revenues.
Forward-looking
statements are subject to numerous assumptions, risks and uncertainties, which
change over time. Forward-looking statements speak only as of the date they are
made, and we assume no duty to update forward-looking statements. New factors
emerge from time to time, and it is not possible for us to predict which factors
will arise. In addition, we cannot assess the impact of each factor on our
business or the extent to which any factor, or combination of factors, may cause
actual results to differ materially from those contained in any forward-looking
statements.
Actual
results could differ materially from those currently anticipated due to a number
of factors, including those set forth in this prospectus under the
heading “Risk Factors”; the risk that we may be unable to continue as a
going concern as a result of our inability to raise sufficient capital for our
operational needs; the possibility that we may be delisted from trading on the
Nasdaq Capital Market; the volatility of our common stock; risks relating to the
need for additional capital and the uncertainty of securing additional funding
on favorable terms; the failure to consummate a transaction to monetize our
Thalomid® royalty stream for any reason, including our inability to obtain the
required third-party consents; declines in actual sales of Thalomid® resulting
in reduced royalty payments; risks associated with our product candidates; the
early-stage products under development; results in preclinical models are not
necessarily indicative of clinical results; uncertainties relating to
preclinical and clinical trials, including delays to the commencement of such
trials; success in the clinical development of any products; dependence on third
parties; and risks relating to the commercialization, if any, of
our proposed products (such as marketing, safety, regulatory, patent,
product liability, supply, competition and other risks).
You are
encouraged to review the Risk Factors included in this
prospectus.
USE
OF PROCEEDS
We will
not receive any proceeds from the sale of the shares of our common stock by the
selling stockholders.
The
selling stockholders will pay any underwriting discounts and commissions and
expenses incurred by the selling stockholders in disposing of the shares. We
will bear all other costs, fees and expenses incurred in effecting the issuance
and registration of the shares covered by this prospectus, including, without
limitation, all registration and filing fees, NASDAQ Capital Market listing fees
and fees and expenses of our counsel and our accountants.
SELLING
STOCKHOLDERS
The
shares listed in this prospectus are issued as consideration for the
satisfaction of a milestone in connection with our acquisition of Miikana
Therapeutics Inc. in January 2006.
The
following table sets forth information with respect to the number of shares of
common stock beneficially owned by the selling stockholders named below and as
adjusted to give effect to the sale of the shares offered hereby. The shares
beneficially owned have been determined in accordance with rules promulgated by
the SEC, and the information is not necessarily indicative of beneficial
ownership for any other purpose.
The
information in the table below is current as of May 14,
2010. All information contained in the table is based upon
information provided to us by the selling stockholders and we have not
independently verified this information. The selling stockholders are not making
any representation that any shares covered by the prospectus will be offered for
sale.
The
selling stockholders may from time to time offer and sell pursuant to this
prospectus any or all of the common stock being registered. We are
registering the shares of common stock in order to permit the selling
stockholders to offer the shares for resale from time to time. No
affiliate of any of the selling stockholders has held any position or office
with us or any of our affiliates and no selling stockholder has had any other
material relationship with us or any of our affiliates within the past three
years other than as a result of its ownership of shares of equity
securities.
As
explained below under “Plan of Distribution,” we have agreed with the selling
stockholders to bear certain expenses (other than broker discounts and
commissions, if any) in connection with the registration statement, which
includes this prospectus.
We
considered the following factors and made the following assumptions regarding
the table:
•
beneficial
ownership is determined under Section 13(d) of the Securities Exchange Act of
1934 and generally includes voting or investment power with respect to
securities and including any securities that grant the selling stockholder the
right to acquire common stock within 60 days of May 14, 2010;
•
unless otherwise
indicated below, to our knowledge, the selling stockholders named below have
sole voting and investment power with respect to their shares of common stock,
except to the extent authority is shared by spouses under applicable law;
and
•
the “Number of
Shares Beneficially Owned After Offering” column assumes the sale of all shares
offered pursuant to this registration statement.
Notwithstanding
these assumptions, the selling stockholders may sell less than all of the shares
listed on the table. In addition, the shares listed below may be sold pursuant
to this prospectus or in privately negotiated
transactions. Accordingly, we cannot estimate the number of
shares of common stock that the selling stockholders will sell under this
prospectus.
The
column entitled “Percentage Beneficial Ownership After Offering” in the table
below is based upon 9,226,590 shares of our Common Stock outstanding as of
June 10, 2010 (as adjusted to reflect the reverse stock split).
On July
1, 2010, we affected a one-for-eleven reverse stock split. The information in
the table below reflects such reverse stock split.
|
|
Number
of Shares
|
|
|
|
|
|
|
|
|
Beneficially
Owned
|
|
|
|
Number
of Shares
|
|
Percentage
|
|
|
Prior
to Offering
|
|
Number
of
|
|
Beneficially
Owned
|
|
Beneficial
Ownership
|
Selling
Stockholder
|
|
(1)(2)
|
|
Shares
Offered (3)
|
|
After
Offering (3)
|
|
After
Offering
|
5AM
Ventures, LLC (4)
|
|
79,174
|
|
79,174
|
|
0
|
|
-
|
5AM
Co-Investors, LLC (5)
|
|
10,195
|
|
10,195
|
|
0
|
|
-
|
Aravis
Venture I L.P (6), (7)
|
|
89,369
|
|
89,369
|
|
0
|
|
-
|
Queensland
Asset Management Ltd.
|
|
272,566
|
|
64,123
|
|
208,442
|
|
2.2%
|
Norvartis
BioVenture Ltd.
|
|
36,016
|
|
36,016
|
|
0
|
|
-
|
J.
Russell Pitto
|
|
14,396
|
|
9,672
|
|
4,723
|
|
*
|
GC&H
Investments, LLC(8)
|
|
939
|
|
939
|
|
0
|
|
-
|
Roche
Finance Ltd.
|
|
43,080
|
|
43,080
|
|
0
|
|
-
|
Sampath-Kumar
Anandan
|
|
2,071
|
|
722
|
|
1,349
|
|
*
|
Patricia
Donchin
|
|
186
|
|
83
|
|
103
|
|
*
|
S.
Gail Eckhardt (9)
|
|
11,578
|
|
9,030
|
|
2,548
|
|
*
|
Daniel
F. Hoth, Jr & Kim Regan TTEES, Hoth & Regan Trust
|
|
80
|
|
36
|
|
44
|
|
*
|
Jenny
Kopcynzski
|
|
208
|
|
132
|
|
76
|
|
*
|
William
LaFayette
|
|
97
|
|
43
|
|
53
|
|
*
|
Bernadine
Leung
|
|
202
|
|
90
|
|
112
|
|
*
|
Tak
Wah Mak (10)
|
|
76,040
|
|
21,673
|
|
54,366
|
|
*
|
Andrew
Myers
|
|
569
|
|
361
|
|
208
|
|
*
|
Anthony
Neri
|
|
2,176
|
|
1,264
|
|
912
|
|
*
|
Michelle
Lyn O’Connor
|
|
92
|
|
43
|
|
49
|
|
*
|
Colleen
Paige
|
|
4,855
|
|
2,167
|
|
2,687
|
|
*
|
Dinesh
Patel (11)
|
|
15,668
|
|
15,532
|
|
135
|
|
*
|
ProPharma
International Partners Inc.
|
|
1,305
|
|
875
|
|
454
|
|
*
|
Daniel
H. Rich
|
|
404
|
|
180
|
|
223
|
|
*
|
Scott
Rocklage (12)
|
|
16,347
|
|
7,224
|
|
9,123
|
|
*
|
Laura
Shawver (13)
|
|
541
|
|
541
|
|
0
|
|
-
|
Ken
Taymor
|
|
296
|
|
132
|
|
164
|
|
*
|
University
Health Network
|
|
6,186
|
|
2,889
|
|
3,296
|
|
*
|
Venture
Lending & Leasing IV, LLC
|
|
11,787
|
|
3,142
|
|
8,644
|
|
*
|
John
Ward
|
|
2,534
|
|
1,083
|
|
1,450
|
|
*
|
Hans
Wigzell
|
|
404
|
|
180
|
|
224
|
|
*
|
Xiao-Yi
Xiao
|
|
3,236
|
|
1,444
|
|
1,791
|
|
*
|
John
Young
|
|
80
|
|
36
|
|
44
|
|
*
|
Robert
Zimmerman
|
|
121
|
|
54
|
|
67
|
|
*
|
Rudolf
Martin Zinkernagel (14)
|
|
7,561
|
|
180
|
|
7,381
|
|
*
|
Lynne
Zydowsky
|
|
1,830
|
|
1,830
|
|
0
|
|
-
|
(1)
|
This
registration statement shall also cover any additional shares of common
stock which become issuable in connection with the shares registered for
sale hereby as a result of any stock dividend, stock split,
recapitalization, or other similar transaction effected without receipt of
consideration which results in an increase in the number of outstanding
shares of common stock.
|
(2)
|
The
aggregate number of shares held by each selling stockholder includes
shares held prior to the shares registered herein, and is based on
information provided to us by the selling stockholders without independent
verification.
|
(3)
|
We
do not know when or in what amounts a selling stockholder may offer shares
for sale. The selling stockholders might not sell any or all of the shares
offered by this prospectus. Because the selling stockholders may offer all
or some of the shares pursuant to this offering and because there are
currently no agreements, arrangements or understandings with respect to
the sale of any of the shares, we cannot estimate the number of the shares
that will be held by the selling stockholders after completion of the
offering. However, for purposes of this table, we have assumed that: (i)
after completion of the offering, none of the shares covered by this
prospectus will be held by the selling stockholders and (ii) the selling
stockholders have not sold or disposed of any of the shares held prior to
the filing of this registration
statement.
|
(4)
|
The
investing and voting power of the shares held by 5AM Ventures, LLC are
controlled by its Manager, 5AM Partners LLC, which is a
member of 5AM Ventures LLC. The aforementioned 5AM Partners LLC
disclaims beneficial ownership with respect to any shares held by 5AM
Ventures, LLC except to the extent of its pecuniary interest
therein.
|
(5)
|
The
investing and voting power of the shares held by 5AM Co-Investors, LLC are
controlled by its Manager, 5AM Partners LLC. The aforementioned
entity disclaims beneficial ownership with respect to any shares held by
5AMCo-Investors, LLC except to the extent of its pecuniary interest
therein.
|
(6)
|
Aravis
Venture I L.P. is a member of 5AM Ventures LLC. The
aforementioned Aravis Venture I L.P. disclaims beneficial ownership with
respect to any shares held by 5AM Ventures, LLC except to the extent of
its pecuniary interest therein.
|
(7)
|
The
investing and voting power of the shares held by Aravis Venture I L.P. are
controlled by its general partner, Aravis General Partner,
Ltd. The aforementioned entity disclaims beneficial ownership
with respect to any shares held by Aravis Venture I L.P. except to the
extent of their pecuniary interest
therein.
|
(8)
|
GC&H
Investments LLC is a member of 5AM Co-Investors LLC. The
aforementioned entity disclaims beneficial ownership with respect to any
shares held by 5AM Co-Investors, LLC except to the extent of its pecuniary
interest therein.
|
(9)
|
Includes 455
shares of Common Stock issuable pursuant to presently exercisable stock
options. Gail Eckhardt has served as a scientific consultant to
the Company since 2000.
|
(10)
|
Tak
Mak is a scientific advisor to Aravis General Partner, Ltd., the general
partner of Aravis Venture I L.P. The aforementioned individual
disclaims beneficial ownership with respect to any shares held by Aravis
Venture I L.P., except to the extent of his pecuniary interest
therein.
|
(11)
|
Dinesh
V. Patel is a member of 5AM Co-Investors LLC. The
aforementioned individual disclaims beneficial ownership with respect to
any shares held by 5AM Co-Investors, LLC except to the extent of his
pecuniary interest therein.
|
(12)
|
Scott
M. Rocklage is a member of 5AM Partners, LLC. The
aforementioned individual disclaims beneficial ownership with respect to
any shares held by 5AM Ventures, LLC or 5AM Co-Investors, LLC, except to
the extent of his pecuniary interest
therein.
|
(13)
|
Laura
Shawver has served as a scientific consultant to the Company since
2006.
|
(14)
|
Rolf
Zinkernagel is a scientific advisor to Aravis General Partner, Ltd., the
general partner of Aravis Venture I L.P. The aforementioned
individual disclaims beneficial ownership with respect to any shares held
by Aravis Venture I L.P., except to the extent of his pecuniary interest
therein.
|
*
|
Represents
less than 1%.
|
The
selling stockholders may, from time to time, sell any or all of their shares of
common stock on any stock exchange, market or trading facility on which the
shares are traded or in private transactions. These sales may be at fixed or
negotiated prices. The selling stockholders may use any one or more of the
following methods when selling shares:
•
ordinary
brokerage transactions and transactions in which the broker-dealer solicits
purchasers;
•
block trades in
which the broker-dealer will attempt to sell the shares as agent but may
position and resell a portion of the block as principal to facilitate the
transaction;
•
purchases by a
broker-dealer as principal and resale by the broker-dealer for its
account;
•
an exchange
distribution in accordance with the rules of the applicable
exchange;
•
privately
negotiated transactions;
•
short
sales;
•
broker-dealers
may agree with the selling stockholders to sell a specified number of such
shares at a stipulated price per share;
•
a combination of
any such methods of sale; and
•
any other method
permitted pursuant to applicable law.
The
selling stockholders may also sell shares under Rule 144 under the Securities
Act of 1933 (the “Securities Act”), if available, rather than under this
prospectus.
Broker-dealers
engaged by the selling stockholders may arrange for other brokers-dealers to
participate in sales. Broker-dealers may receive commissions or discounts from
the selling stockholders (or, if any broker-dealer acts as agent for the
purchaser of shares, from the purchaser) in amounts to be negotiated. The
selling stockholders do not expect these commissions and discounts to exceed
what is customary in the types of transactions involved. Any profits on the
resale of shares of common stock by a broker-dealer acting as principal might be
deemed to be underwriting discounts or commissions under the Securities Act.
Discounts, concessions, commissions and similar selling expenses, if any,
attributable to the sale of shares will be borne by a selling stockholder. The
selling stockholders may agree to indemnify any agent, dealer or broker-dealer
that participates in transactions involving sales of the shares if liabilities
are imposed on that person under the Securities Act.
The
selling stockholders may from time to time pledge or grant a security interest
in some or all of the shares of common stock owned by them and, if they default
in the performance of their secured obligations, the pledgees or secured parties
may offer and sell the shares of common stock from time to time under this
prospectus after we have filed a supplement to this prospectus under Rule
424(b)(3) or other applicable provision of the Securities Act supplementing or
amending the list of selling stockholders to include the pledgee, transferee or
other successors in interest as selling stockholders under this
prospectus.
The
selling stockholders also may transfer the shares of common stock in other
circumstances, in which case the transferees, pledgees or other successors in
interest will be the selling beneficial owners for purposes of this prospectus
and may sell the shares of common stock from time to time under this prospectus
after we have filed a supplement to this prospectus under Rule 424(b)(3) or
other applicable provision of the Securities Act supplementing or amending the
list of selling stockholders to include the pledgee, transferee or other
successors in interest as selling stockholders under this
prospectus.
The
selling stockholders and any broker-dealers or agents that are involved in
selling the shares of common stock may be deemed to be “underwriters” within the
meaning of the Securities Act in connection with such sales. In such event, any
commissions received by such broker-dealers or agents and any profit on the
resale of the shares of common stock purchased by them may be deemed to be
underwriting commissions or discounts under the Securities Act.
We are
required to pay all fees and expenses incident to the registration of the shares
of common stock. We have agreed to indemnify the selling stockholders against
certain losses, claims, damages and liabilities, including liabilities under the
Securities Act.
The
selling stockholders have advised us that they have not entered into any
agreements, understandings or arrangements with any underwriters or
broker-dealers regarding the sale of their shares of common stock, nor is there
an underwriter or coordinating broker acting in connection with a proposed sale
of shares of common stock by any selling stockholder. If we are notified by any
selling stockholder that any material arrangement has been entered into with a
broker-dealer for the sale of shares of common stock, if required, we will file
a supplement to this prospectus. If the selling stockholders use this prospectus
for any sale of the shares of common stock, they will be subject to the
prospectus delivery requirements of the Securities Act.
Under
applicable rules and regulations under the Exchange Act, any person engaged in
the distribution of the resale shares may not simultaneously engage in market
making activities with respect to the common stock for the applicable restricted
period, as defined in Regulation M, prior to the commencement of the
distribution. In addition, the selling stockholders will be subject to
applicable provisions of the Exchange Act and the rules and regulations
thereunder, including Regulation M, which may limit the timing of purchases and
sales of shares of the common stock by the selling stockholders or any other
person.
LEGAL
MATTERS
The
validity of the shares of common stock offered hereby has been passed upon for
us by Arnold & Porter LLP, Washington, D.C.
EXPERTS
Ernst
& Young LLP (“Ernst & Young”), independent registered public accounting
firm, has audited our consolidated financial statements included in our Annual
Report on Form 10-K for the year ended December 31, 2009, and the effectiveness
of our internal control over financial reporting as of December 31, 2009, as set
forth in their reports (which contains an explanatory paragraph describing
conditions that raise substantial doubt about the Company's ability to continue
as a going concern as described in Note 1 to the consolidated financial
statements) which are incorporated by reference in this prospectus and elsewhere
in the registration statement. Our financial statements and our
management’s assessment of the effectiveness of internal control over financial
reporting as of December 31, 2009 are incorporated by reference in reliance on
Ernst & Young’s report, given on their authority as experts in
accounting and auditing.
Change
in Independent Registered Public Accounting Firm
On April
2, 2010, our Audit Committee approved the dismissal of Ernst & Young as
our independent registered public accounting firm and engaged Reznick Group,
P.C., Certified Public Accountants (“Reznick”), as our independent auditors for
the fiscal year ending December 31, 2010.
Except
for an explanatory paragraph in the report of Ernst & Young regarding our
consolidated financial statements as of and for the fiscal year ended December
31, 2009 which noted that there was substantial doubt as to our ability to
continue as a going concern, the reports of Ernst & Young on our
consolidated financial statements as of and for the fiscal years ended December
31, 2009 and 2008 did not contain any adverse opinion or disclaimer of opinion
and were not qualified or modified as to uncertainty, audit scope or accounting
principles. The Audit Committee’s decision to dismiss Ernst & Young
was intended to help reduce our expenses.
During
our fiscal years ended December 31, 2009 and 2008 and the subsequent interim
period through April 2, 2010 (the “Relevant Periods”) (i) there were no
disagreements with Ernst & Young on any matter of accounting principles
or practices, financial statement disclosure or auditing scope or procedure,
which disagreements, if not resolved to the satisfaction of Ernst &
Young, would have caused them to make reference thereto in their reports on our
financial statements for such years and (ii) there were no “reportable
events” as defined in Item 304(a)(1)(v) of Regulation S-K.
We
furnished a copy of the above statements to Ernst & Young and, in
response to our request, Ernst & Young furnished us with a letter
addressed to the SEC stating whether or not it agreed with the above
statements. A copy of such letter to the SEC, dated April 6, 2010, was
attached as Exhibit 16.1 to the Current Report on Form 8-K filed by the Company
on April 7, 2010.
During
the Relevant Periods, we, nor anyone on our behalf, consulted with Reznick on
any matter regarding: (i) the application of accounting principles to a
specified transaction, either completed or proposed, or the type of audit
opinion that might be rendered on our consolidated financial statements, and
neither a written report was provided to us nor oral advice was provided that
Reznick concluded was an important factor considered by us in reaching a
decision as to the accounting, auditing or financial reporting issue, or
(ii) a disagreement or a reportable event, as defined in
Item 304(a)(1)(iv) and (v) of Regulation S-K,
respectively.
INCORPORATION
OF CERTAIN DOCUMENTS BY REFERENCE
The SEC
allows us to incorporate by reference the information that we file with the SEC,
which means that we can disclose important information to you by referring you
to those documents. The information incorporated by reference is considered to
be part of this prospectus. These documents may include periodic reports, such
as Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current
Reports on Form 8-K, as well as Proxy Statements. Any documents that we
subsequently file with the SEC will automatically update and replace the
information previously filed with the SEC. Thus, for example, in the case of a
conflict or inconsistency between information set forth in this prospectus and
information incorporated by reference into this prospectus, you should rely on
the information contained in the document that was filed later.
This
prospectus incorporates by reference the documents listed below that we
previously have filed with the SEC and any additional documents that we may file
with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange
Act of 1934 between the date of this prospectus and the termination of the
offering of the securities. These documents contain important information about
us.
|
1.
|
The
Company’s Annual Report on Form 10-K for the year ended December 31, 2009,
filed with the Commission on March 29,
2010.
|
|
2.
|
The
Company’s Quarterly Report on Form 10-Q for the quarter ended March 31,
2010, filed with the Commission on May 17,
2010.
|
|
3.
|
The
Company’s Definitive Proxy Statement on Schedule 14A for its 2010 Annual
Shareholder’s Meeting, filed with the Commission on April 29,
2010.
|
|
4.
|
The
Company’s Current Reports on Form 8-K, filed on January 12, 2010; January
20, 2010; February 4, 2010; March 24, 2010; April 7, 2010; April 9, 2010;
April 16, 2010; June 8, 2010; and July 7,
2010.
|
|
5.
|
The
description of the Company’s common stock contained in the Company’s
Registration Statement on Form 8-A filed under the Exchange Act on May 14,
1996, including any amendment or report filed for the purpose of updating
such description.
|
You can
obtain a copy of any or all of the documents incorporated by reference in this
prospectus (other than an exhibit to a document unless that exhibit is
specifically incorporated by reference into that document) from the SEC on its
web site at http://www.sec.gov. You also can obtain these documents from us
without charge by visiting our web site at http://www.entremed.com or by
requesting them in writing, by email or by telephone at the following
address:
Ginny
Dunn
EntreMed,
Inc.
9640
Medical Center Drive
Rockville,
Maryland 20850
(240)
864-2600
ginnyd@entremed.com
WHERE
YOU CAN FIND MORE INFORMATION
We have
filed with the SEC a registration statement under the Securities Act that
registers the distribution of the securities offered under this prospectus. The
registration statement, including the attached exhibits and schedules and the
information incorporated by reference, contains additional relevant information
about us and the securities. The rules and regulations of the SEC allow us to
omit from this prospectus certain information included in the registration
statement. You can obtain a copy of the registration statement from the SEC at
the address listed below or from the SEC’s Internet site.
We file
reports, proxy statements and other documents with the SEC. 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. You should call 1-800-SEC-0330 for more
information on the public reference room. Our SEC filings are also available to
you on the SEC’s Internet site at http://www.sec.gov.
Entremed, Inc. (MM) (NASDAQ:ENMDD)
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