UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-Q
     
þ   QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2006
     
o   TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from                      to                      .
Commission file number 0-20713
ENTREMED, INC.
(Exact name of registrant as specified in its charter)
         
  Delaware   58-1959440  
         
  (State or other jurisdiction of   (I.R.S. Employer Identification No.)  
  incorporation or organization)      
9640 Medical Center Drive
Rockville, Maryland
 
(Address of principal executive offices)
20850
 
(Zip code)
(240) 864-2600
 
(Registrant’s telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
YES þ      NO o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act.
Large accelerated filer o           Accelerated filer þ           Non-accelerated filer o
Indicate by checkmark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
YES o      NO þ
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the most recent practicable date.
             
    Class   Outstanding at August 3, 2006    
   
 
Common Stock $.01 Par Value
 
 
74,163,498
   
 
 

 


 

ENTREMED, INC.
Table of Contents
         
    PAGE  
PART I. FINANCIAL INFORMATION
       
 
       
Item 1 — Financial Statements
       
 
       
Consolidated Balance Sheets as of June 30, 2006 and December 31, 2005
    3  
 
       
Consolidated Statements of Operations for the Three Months Ended June 30, 2006 and 2005 and the Six Months Ended June 30, 2006 and 2005
    4  
 
       
Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2006 and 2005
    5  
 
       
Notes to Consolidated Financial Statements
    6  
 
       
Item 2 — Management’s Discussion and Analysis of Financial Condition and Results of Operations
    11  
 
       
Item 3 — Quantitative and Qualitative Disclosures About Market Risk
    18  
 
       
Item 4 — Controls and Procedures
    19  
 
       
Part II. OTHER INFORMATION
       
 
       
Item 1 — Legal Proceedings
    19  
 
       
Item 1A – Risk Factors
    19  
 
       
Item 2 — Unregistered Sales of Equity Securities and Use of Proceeds
    19  
 
       
Item 3 — Defaults upon Senior Securities
    20  
 
       
Item 4 — Submission of Matters to a Vote of Security Holders
    20  
 
       
Item 5 — Other Information
    20  
 
       
Item 6 — Exhibits
    21  
 
       
SIGNATURES
    22  
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This report contains certain forward-looking statements within the meaning of Section 27A of the Securities Exchange Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements also may be included in other statements that we make. 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.
Our forward-looking statements are based on information available to us today, and we will not update these statements. Although we believe that the expectations reflected in such forward-looking statements are reasonable as of the date thereof, actual results could differ materially from those currently anticipated due to a number of factors, including risks relating to the early stage of our product candidates under development, operating losses and anticipated future losses; variations in sales of Thalomid; the value of our common stock; our need for additional capital; intense competition and rapid technological change in the biopharmaceutical industry; uncertainties relating to our patent and proprietary rights; uncertainties relating to clinical trials, estimated clinical trial commencement dates, government regulation and uncertainties of obtaining regulatory approval on a timely basis or at all. Additional information on the factors and risks that could affect our business, financial condition and results of operations, are contained in our filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov.

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PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
EntreMed, Inc.
Consolidated Balance Sheets
                 
    June 30, 2006     December 31, 2005  
    (Unaudited)          
ASSETS
               
Current assets:
               
Cash and cash equivalents
  $ 13,485,394     $ 11,407,652  
Short-term investments
    31,605,781       18,674,736  
Accounts receivable
    71,368       3,723,433  
Note receivable
          1,000,000  
Interest receivable
    74,178       181,231  
Prepaid expenses and other
    175,324       338,462  
 
           
Total current assets
    45,412,045       35,325,514  
 
               
Property and equipment, net
    886,609       915,337  
Other assets
    5,943       191,034  
 
           
Total assets
  $ 46,304,597     $ 36,431,885  
 
           
 
               
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
Current liabilities:
               
Accounts payable
  $ 2,744,010     $ 5,487,014  
Payable to related parties
    250,861       228,380  
Accrued liabilities
    2,544,967       1,038,975  
Current portion of loan payable
    820,387        
Current portion of deferred rent
    75,338       60,969  
 
           
Total current liabilities
    6,435,563       6,815,338  
 
               
Deferred rent, less current portion
    187,701       230,206  
Loan payable, less current portion
    327,200        
 
           
 
               
Total liabilities
    6,950,464       7,045,544  
 
           
 
               
Minority interest
    17,355       17,151  
 
               
Stockholders’ equity:
               
 
               
Convertible preferred stock, $1.00 par value;
               
5,000,000 shares authorized and 3,350,000 shares issued and outstanding at June 30, 2006 and December 31, 2005, respectively (liquidation value — $27,637,500 and $33,500,000, respectively
    3,350,000       3,350,000  
Common stock, $.01 par value:
               
170,000,000 shares authorized, 74,163,498 and 51,106,857 shares issued and outstanding at June 30, 2006 and December 31,2005, Respectively
    740,560       511,069  
Additional paid-in capital
    345,764,718       295,392,194  
Deferred stock-based compensation
          (102,000 )
Treasury stock, at cost: 874,999 shares held at June 30, 2006 and December 31, 2005, respectively
    (8,034,244 )     (8,034,244 )
Accumulated deficit
    (302,484,256 )     (261,747,829 )
 
           
Total stockholders’ equity
    39,336,778       29,369,190  
 
           
Total liabilities and stockholders’ equity
  $ 46,304,597     $ 36,431,885  
 
           
See accompanying notes.

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EntreMed, Inc.
Consolidated Statements of Operations
(Unaudited)
                                 
    Three Months Ended     Six Months Ended  
    June 30, 2006     June 30, 2005     June 30, 2006     June 30, 2005  
Revenues:
                               
Licensing
  $     $ 567,118     $     $ 590,992  
Royalties
                      1,375  
Other
          12,343             12,343  
 
                       
 
          579,461             604,710  
 
                               
Costs and expenses:
                               
Research and development
    4,258,206       3,812,353       8,269,306       8,191,709  
General and administrative
    1,942,652       1,339,150       3,759,346       2,599,972  
Acquired In-Process R&D
    353,833             29,481,894        
 
                       
 
    6,554,691       5,151,503       41,510,546       10,791,681  
 
                               
Investment income
    569,617       271,832       848,082       430,293  
Interest expense
    (42,575 )           (91,288 )      
Gain on sale of assets
    1,925             17,325        
 
                       
 
                               
Net Loss
    (6,025,724 )     (4,300,210 )     (40,736,427 )     (9,756,678 )
 
                               
Dividends on Series A convertible preferred stock
    (251,250 )     (251,250 )     (502,500 )     (502,500 )
 
                               
Net loss attributable to common shareholders
  $ (6,276,974 )   $ (4,551,460 )   $ (41,238,927 )   $ (10,259,178 )
 
                       
 
                               
Net loss per share (basic and diluted)
  $ (0.09 )   $ (0.09 )   $ (0.59 )   $ (0.22 )
 
                       
Weighted average number of common shares outstanding (basic and diluted)
    73,194,814       49,819,569       69,765,434       46,324,989  
 
                       
See accompanying notes.

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EntreMed, Inc.
Consolidated Statements of Cash Flows
(Unaudited)
                 
    SIX MONTH PERIOD ENDED  
    JUNE 30,  
    2006     2005  
CASH FLOWS FROM OPERATING ACTIVITIES
               
Net loss
  $ (40,736,427 )   $ (9,756,678 )
Adjustments to reconcile net loss to net cash used by operating activities:
               
Depreciation and amortization
    236,513       251,474  
Gain on sale of fixed assets
    (17,325 )      
Write-off of acquired in-process R&D
    29,481,894        
Discount of premium on ST investments
    (479,351 )      
Stock-based compensation expense
    864,526        
Amortization of deferred stock-based compensation expense
    43,713        
Minority interest
    204       42  
Changes in operating assets and liabilities, net of acquisition:
               
Accounts receivable
    3,701,347       3,121,646  
Interest receivable
    107,053       15,056  
Prepaid expenses and other
    209,417       232,955  
Deferred rent
    (28,136 )     (14,186 )
Accounts payable
    (2,818,638 )     359,854  
Payable to related parties
    22,481       63,236  
Accrued liabilities
    (803,071 )     (728,055 )
Deferred revenue
          (190,992 )
 
           
Net cash used in operating activities
    (10,215,800 )     (6,645,648 )
 
               
CASH FLOWS FROM INVESTING ACTIVITIES
               
Acquisition, net of cash received
    (2,906,218 )      
Proceeds from sale of property and equipment, net
    17,325        
Purchases of short term investments
    (34,131,694 )     (15,132,345 )
Maturities of short term investments
    21,680,000        
Purchases of furniture and equipment
    (58,314 )     (136,964 )
 
           
Net cash used in investing activities
    (15,398,901 )     (15,269,309 )
 
               
CASH FLOWS FROM FINANCING ACTIVITIES
               
Repayment of loan
    (300,536 )      
Net proceeds from sale of common stock
    27,992,979       9,904,704  
 
           
Net cash provided by financing activities
    27,692,443       9,904,704  
 
Net increase (decrease) in cash and cash equivalents
    2,077,742       (12,010,253 )
Cash and cash equivalents at beginning of period
    11,407,652       20,425,495  
 
           
Cash and cash equivalents at end of period
  $ 13,485,394     $ 8,415,242  
 
           
 
               
Supplemental disclosure of cash flow information:
               
Cash paid during the period for interest
  $ 91,288     $  
Non-cash investing activity:
               
Stock issued in connection with the acquisition
  $ 21,920,801     $  
See accompanying notes.

5


 

ENTREMED, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2006 (unaudited)
1. Basis of Presentation
          Our accompanying 2006 unaudited consolidated financial information includes the accounts of our controlled subsidiaries, Miikana Therapeutics, Inc. (Miikana) and Cytokine Sciences, Inc. All intercompany balances and transactions have been eliminated in consolidation.
          The accompanying unaudited consolidated financial statements have been prepared in accordance with U. S. generally accepted accounting principles for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, such consolidated financial statements do not include all of the information and disclosures required by U. S. generally accepted accounting principles for complete financial statements. In the opinion of our management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the six-month period ended June 30, 2006 are not necessarily indicative of the results that may be expected for the year ending December 31, 2006. For further information, refer to our audited consolidated financial statements and footnotes thereto included in our Form 10-K for the year ended December 31, 2005.
2. Short-Term Investments
          Short-term investments consist primarily of corporate debt securities, all of which mature within one year. The Company has classified these investments as available for sale. Such securities are carried at aggregate cost which approximates market. The cost of securities sold is calculated using the specific identification method. Unrealized gains and losses on these securities, if any, are reported as accumulated other comprehensive income (loss), which is a separate component of stockholders’ equity. There were no unrealized gains or losses as of June 30, 2006. Realized gains and losses and declines in value judged to be other than temporary on securities available for sale, if any, are included in operations. Short-term investments are principally uninsured and subject to normal credit risk.
3. Stock-Based Compensation
          The Company has adopted incentive and nonqualified stock option plans whereby 11,983,333 shares of the Company’s common stock were reserved for grants to various executive, scientific and administrative personnel of the Company as well as outside directors and consultants, of which 967,893 shares remain available for grant under the Company’s 2001 Long-Term Incentive Plan as of June 30, 2006. Options granted under the plan generally vest over a period of up to four years, are not transferable and generally expire ten years from the date of grant.
          Effective January 1, 2006, the Company adopted the fair value recognition provisions of Statement 123 (revised 2004) “Share-Based Payment” (“SFAS 123R”) and interpretative literature within SEC Staff Accounting Bulletin No. 107, Share-Based Payment , (SAB 107), using the modified prospective transition method and therefore has not restated results for prior periods. Under this transition method, stock-based compensation expense for the six months ended June 30, 2006

6


 

includes compensation expense for all stock-based compensation awards granted prior to, but not yet vested as of January 1, 2006, based on the original grant date fair value estimated in accordance with the provisions of SFAS No. 123, “Accounting for Stock-Based Compensation” (“SFAS 123”). Stock-based compensation expense for all stock-based compensation awards granted after January 1, 2006 is based on the grant date fair value estimated in accordance with the provisions of SFAS 123R. The Company recognizes these compensation costs for stock options granted prior to January 1, 2006 on an accelerated method, and for stock options granted after January 1, 2006 the compensation costs are recognized based on a straight-line method over the requisite service period, which is generally the option vesting term ranging from three to four years. Prior to the adoption of SFAS 123R, the Company recorded stock-based compensation under Accounting Principles Board (“APB”) Opinion No. 25, “Accounting for Stock Issued to Employees” (“APB 25”).
     The Company uses the Black-Scholes-Merton valuation model to estimate the fair value of stock options granted to employees. Option valuation models, including Black-Scholes-Merton, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant date fair value of an award. These assumptions include the risk free rate of interest, expected dividend yield, expected volatility, and the expected life of the award.
     Expected Volatility—Volatility is a measure of the amount by which a financial variable such as a share price has fluctuated (historical volatility) or is expected to fluctuate (expected volatility) during a period. The Company uses the historical volatility based on the weekly price observations of its common stock during the period immediately preceding the share-based award grant that is equal in length to the award’s expected term (up to a maximum of five years). EntreMed believes that historical volatility within the last five years represents the best estimate of future long term volatility.
     Risk-Free Interest Rate—This is the average interest rate consistent with the yield available on a U.S. Treasury note (with a term equal to the expected term of the underlying grants) at the date the option was granted.
     Expected Term of Options—This is the period of time that the options granted are expected to remain outstanding. EntreMed adopted SAB 107’s simplified method for estimating the expected term of share-based awards granted during the six months ending June 30, 2006.
     Expected Dividend Yield—EntreMed has never declared or paid dividends on its common stock and does not anticipate paying any dividends in the foreseeable future. As such, the dividend yield percentage is assumed to be zero.
     Forfeiture Rate—This is the estimated percentage of options granted that are expected to be forfeited or cancelled on an annual basis before becoming fully vested. The Company estimates the forfeiture rate based on historical forfeiture experience for similar levels of employees to whom options were granted.

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     Following are the weighted-average assumptions used in valuing the stock options granted to employees during the six-month periods ended June 30, 2006 and 2005:
                 
    SIX MONTH PERIOD ENDED
    JUNE 30
    2006   2005
Expected volatility
    102.24 %     107.85 %
Risk-free interest rate
    5.13 %     3.88 %
Expected term of option
     5 years      5 years
Forfeiture rate
    5.00 %           N/A
Expected dividend yield
    0.00 %     0.00 %
          A summary of the Company’s stock options and warrants granted to employees and directors and related information for the six months ended June 30, 2006 follows:
                 
            Weighted  
            Average  
    Number of     Exercise  
All Employee Options   Shares     Price  
Outstanding at January 1, 2006
    7,962,017     $ 9.04  
Granted
    572,336       1.65  
Exercised
    (7,500 )     1.09  
Expired
    (138,736 )     15.01  
Forfeited
           
 
           
Outstanding at June 30, 2006
    8,388,117     $ 8.47  
 
           
Vested and expected to vest at June 30, 2006
    8,324,124     $ 8.52  
 
           
Exercisable at June 30, 2006
    7,108,259     $ 9.58  
 
           
          The weighted average fair value of stock options granted during the six and three-month periods ended June 30, 2006 were $1.28 per share and $1.24 per share, respectively.
          As of June 30, 2006, there was approximately $1.1 million of total unrecognized compensation cost related to nonvested employee stock options. That cost is expected to be recognized over a weighted-average period of up to four years.
          Cash received from option exercises under all share-based payment arrangements for the six months ended June 30, 2006 and 2005, was $11,456 and $151,865, respectively. Due to the availability of net operating loss carryforwards and research tax credits, tax deductions for option exercises were not recognized in the six months ended June 30, 2006

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          Total employee share-based compensation expense recognized for the six months ended June 30, 2006 are as follows:
         
    Six Months Ended  
    June 30, 2006  
Research and development
  $ 201,800  
General and administrative
    706,438  
 
     
Share-based compensation expense
  $ 908,238  
 
     
Net share-based compensation expense, per common share:
       
Basic and diluted
  $ 0.013  
 
     
          The following table illustrates the effect on net loss and net loss per share if the Company had applied the fair value recognition provision of Statement 123 using the assumptions noted above to options granted under the Company’s stock option plans for the six months ended June 30, 2005. For purposes of this pro-forma disclosure, the value of the options is estimated using a Black-Scholes Merton option-pricing formula and amortized to expense over the options’ vesting periods.
         
    Six months ended  
    June 30, 2005  
Actual net loss
  $ (9,756,678 )
Deduct: Stock-based employee compensation expense if SFAS No.123 had been applied to all awards
    (464,029 )
Add: Stock-based employee compensation included in reported net loss
     
 
     
Proforma net loss
  $ (10,220,707 )
 
       
Dividend on Series A convertible preferred stock
    (502,500 )
 
     
Proforma net loss per share available to common shareholders
  $ (10,723,207 )
 
     
 
       
Net loss per share:
       
Basic and diluted — as reported
  $ (.22 )
Basic and diluted — pro forma
  $ (.23 )
4. Acquisition
          In January 2006 the Company acquired Miikana Therapeutics, a private biotechnology company. Pursuant to the Merger Agreement, the Company acquired all of the outstanding capital stock of Miikana Therapeutics, Inc. in exchange for 9.96 million shares of common stock and the assumption of certain obligations. In addition, based on the success of the acquired pre-clinical programs, the Company may pay up to an additional $18 million upon the achievement of certain clinical and regulatory milestones. Such additional payments will be made in cash or shares of stock at the Company’s option. Through the acquisition, the Company acquired rights to MKC-1, a Phase 2 clinical candidate licensed from Hoffman-LaRoche, Inc. (“Roche”) by Miikana in April 2005. Under the terms of the agreement, Roche may be entitled to receive future payments upon successful completion of developmental milestones. The Company does not anticipate reaching any of these milestones in 2006. Roche is also eligible to receive royalties on sales and certain one-time payments based on attainment of annual sales milestones. The Company has also acted as guarantor on the unpaid balance of approximately $1.1 million under a loan agreement with Venture Lending & Leasing IV, Inc. dated October 1, 2004. The final payment is due in October 2007.

9


 

      Miikana purchase price allocation
    Miikana is a development stage company, accordingly, the acquisition of Miikana is treated as an asset purchase. In accordance with EITF 98-3 “Determining Whether a Nonmonetary Transaction Involves Receipt of Productive Asset or of a Business,” the purchase price was first allocated to the tangible assets acquired and liabilities assumed based on the estimated fair values at the acquisition date. The balance of the purchase price was allocated to intangible assets and recorded as in-process research and development as the research and development projects in Miikana’s pipeline, as of the acquisition date, had not reached technological feasibility and had no alternative use.
     We believe the fair values assigned to the assets acquired and liabilities assumed are based upon reasonable assumptions given current available facts and circumstances.
     The total purchase price allocated was $30.1 million, consisting of 9,964,000 shares of our common stock with a fair value of $21.9 million, assumed debt of $1.5 million, assumed current liabilities of $2.7 million, $1 million loaned to Miikana prior to the closing and acquisition costs of $3 million. The fair value of common stock was determined using the closing price at the date of acquisition. The change from the initial allocation is a result of additional incidental expenses related to the acquisition transaction.
     The allocation is as follows:
         
Fair value of net tangible assets acquired
  $ 600,000  
In- process research and development
    29,500,000  
 
     
Total
  $ 30,100,000  
 
     
5. Licensing Agreement
          In January 2006, the Company entered into a License Agreement with Elan Corporation, plc in which the Company has been granted rights to utilize Elan’s proprietary NanoCrystal Technology to develop the oncology product candidate, Panzem ® NCD. Under the terms of the License Agreement, Elan is eligible to receive payments upon the achievement of certain clinical, manufacturing, and regulatory milestones. Milestones related to the initiation of Phase 2 clinical trials have been paid and there are no additional milestones due at this time. Additionally, Elan will receive royalty payments based on sales of Panzem ® NCD. Under the License Agreement and corresponding Services Agreement, Elan will manufacture EntreMed’s Panzem ® NCD, a NanoCrystal Technology formulation with improved bioavailability and absorption.
6. Sale of Securities
          In February 2006, the Company entered into definitive agreements with institutional investors for the private placement of units consisting of shares of common stock and warrants at a purchase price of $2.3125 per unit. In connection with the placement, the Company received gross proceeds of approximately $30 million and issued approximately 13 million shares of common stock and warrants to purchase up to 6.5 million additional shares of common stock at an exercise price of $2.50 per share. The warrants are not exercisable until six months after the closing. In April 2006, the Company registered the resale of the shares and the shares underlying the warrants.

10


 

7. Related Party Transactions
          The Company receives legal services from a law firm with which one of the Company’s former officers is associated. During the six months ended June 30, 2006 these services totaled $516,000, the majority representing patent work. These costs are recorded as research and development expenses of $379,000, general and administrative expenses of $121,000 and costs related to the Miikana acquisition of $16,000. At June 30, 2006 amounts payable to this party are reflected on our balance sheet as payable to related parties in the amount of $251,000. The Company completed a sale of common stock and warrants in February 2006. Celgene Corporation, the Company’s largest shareholder, acquired 864,864 shares of common stock and 432,432 warrants convertible into shares of common stock in the transaction (see footnote 6).
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
OVERVIEW
          We are a clinical-stage pharmaceutical company focused on developing next generation multi-mechanism oncology and anti-inflammatory drugs that target disease cells directly and the blood vessels that nourish them. We are focused on developing drugs that are safe and convenient, and provide the potential for improved patient outcomes. Panzem ® (2-methoxyestradiol or 2ME2), one of our lead drug candidates, is currently in Phase 2 clinical trials for cancer, as well as in preclinical development for rheumatoid arthritis. MKC-1, a novel cell cycle inhibitor, is also in Phase 2 clinical trials for cancer. ENMD-1198, a novel tubulin binding agent discovered by EntreMed, is currently in a Phase 1 clinical trial for cancer. As our research and development efforts have shifted to a more clinical focus, expenditures have increased and will continue to increase in the second half of 2006 as we secure material to support on-going and planned trials for our three clinical-stage drug candidates.
          In January 2006, we acquired Miikana Therapeutics, Inc., a clinical-stage biopharmaceutical company with research laboratories in Toronto, Canada. As a result of the transaction, we enhanced our pipeline with the addition of a Phase 2 drug candidate, MKC-1, and two preclinical programs, one in aurora kinase inhibition and one in HDAC inhibition.
          Our goal is to develop and commercialize drugs based on our scientific expertise in angiogenesis, cell cycle regulation and inflammation — processes vital to the progression of cancer and other diseases. Our three product candidates are based on these mechanisms. Our expertise has also led to the identification of new molecules, including new chemical entities derived from 2ME2, modulators of fibroblast growth factor-2 (FGF-2) activity, proteinase activated receptor-2 (PAR-2) antagonists, and tissue factor pathway inhibitor (TFPI) peptides.
          In order to further advance of our commercial objectives, we may seek strategic alliances, licensing relationships and co-development partnerships with other companies to develop compounds for both oncology and non-oncology therapeutic areas.

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CRITICAL ACCOUNTING POLICIES AND THE USE OF ESTIMATES
          The preparation of our financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions that affect the amounts reported in our consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates. Our critical accounting policies, including the items in our financial statements requiring significant estimates and judgments, are as follows:
    Revenue Recognition — The Company recognizes revenue in accordance with the provisions of Staff Accounting Bulletin No. 104, Revenue Recognition, whereby revenue is not recognized until it is realized or realizable and earned. Revenue is recognized when all of the following criteria are met: persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price to the buyer is fixed and determinable and collectibility is reasonably assured.
    Royalty Revenue — Royalties from licenses are based on third-party sales and recorded as earned in accordance with contract terms, when third-party results are reliably measured and collectibility is reasonably assured. We expect that the majority of our 2006 revenues will be from royalties on the sale of Thalomid ® , which we expect to begin to recognize in the third quarter. In 2004 certain provisions of a purchase agreement dated June 14, 2001 by and between Bioventure Investments kft (“Bioventure”) and the Company were satisfied, and, as a result, beginning in 2005 we became entitled to share in the royalty payments received by Royalty Pharma Finance Trust, successor to Bioventure, 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. The Company also is eligible to receive royalty payments under a February 2004 agreement with Children’s Medical Center Corporation (“CMCC”) and Alchemgen Therapeutics. Under the agreement, Alchemgen received rights to market endostatin and angiostatin in Asia. We do not expect to receive royalties under this agreement in 2006. In the future, royalty payments, if any, will be recorded as revenue when received and/or when collectibility is reasonably assured.
    Research and Development — Research and development expenses consist primarily of compensation and other expenses related to research and development personnel, research collaborations, costs associated with pre-clinical testing and clinical trials of our product candidates, including the costs of manufacturing the product candidates, and facilities expenses. Research and development costs are expensed as incurred.
 
    Stock-Based Compensation — Issued in December 2004, Statement of Financial Accounting Standards No. 123R (“SFAS 123R”) requires public companies to recognize expense associated with share-based compensation arrangements, including employee stock options and stock purchase plans, using a fair value-based option pricing model, and eliminates the alternative to use the intrinsic value method of accounting for share-based payments. SFAS 123R is effective for our fiscal year beginning January 1, 2006. Adoption of the expense provisions of SFAS 123R have a material impact on our results of operations. We have applied the modified prospective transition method; accordingly, compensation expense is reflected in the financial statements beginning January 1, 2006 with no restatement of prior periods. Compensation expense is recognized for awards that are granted, modified, repurchased or cancelled on or after January 1, 2006, as well as for the portion of awards previously granted that have not vested as of January 1, 2006. For the adoption of SFAS 123R, we have selected the straight-line expense attribution method, whereas our previous expense attribution method was the graded-vesting method, an accelerated method, described by FIN 28.

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     Any future changes to our share-based compensation strategy or programs would likely affect the amount of compensation expense recognized under SFAS 123R and the comparability to our prior period footnote disclosures of pro forma net earnings and earnings per share. Share-based compensation expense recognized in the three and six months ended June 30, 2006 totaled $515,000 and $908,000, respectively.
RESULTS OF OPERATIONS
For the Three and Six Months Ended June 30, 2006 and June 30, 2005.
          – Revenues. No revenues were recorded in the three and six-month periods ended June 30, 2006 compared to $579,000 and $605,000 in the corresponding 2005 periods. The 2005 revenues represent the accelerated recognition of deferred licensing revenues from the January 2002 agreement with Allergan and the recognition of a $400,000 licensing payment from Alchemgen in May 2005. Our 2006 revenues, for the most part, will result from Celgene’s sale of Thalomid ® . As previously reported, we continue to earn royalties pursuant to a 2001 agreement with Royalty Pharma, as noted above. We do not expect to record royalty revenues in 2006 until the third quarter.
           Research and Development Expenses . At June 30, 2006, accumulated direct project expenses for Panzem ® , our lead drug candidate, totaled $38,030,000 and for ENMD-1198, a tubulin binding agent that recently entered Phase 1 trials for cancer, totaled $6,172,000. Reflected in our R&D expenses totaling $8,269,000 for the six-month period ended June 30, 2006 are direct project expenses for Panzem ® of $2,735,000, $799,000 related to ENMD-1198, and $887,000 related to MKC-1, a Phase 2 clinical candidate acquired with Miikana in January 2006. Research and development expenses for the corresponding 2005 period were $8,192,000, which included $2,774,000 direct project expenses for Panzem ® and $1,478,000 related to ENMD-1198. There were no Miikana costs reported in 2005. For the three-month period ended June 30, 2006, research and development expenses totaled $4,258,000, an increase from $3,812,000 for the comparable 2005 period. Included in the 2006 three-month period are expenses related to Panzem ® of $1,456,000 versus $1,394,000 in 2005, expenses related to our 2ME2 analog program of $386,000 versus $667,000 in 2005 and expenses related to MKC-1 of $455,000 versus $0 in 2005. The 2006 research and development expenses reflect the cost of initiating and supporting multiple Phase 2 trials for Panzem Ò NCD, a multi-site Phase 2 trial for MKC-1 and also a Phase 1 clinical trial for ENMD-1198. Our research and development expenses will increase with additional patient enrollment and the initiation of additional clinical trials.
          The balance of our R&D expenditures includes facilities costs and other departmental overhead, and expenditures related to the advancement of our pre-clinical pipeline. These costs totaled $3,848,000 and $2,940,000 for the six-month period ended June 30, 2006 and 2005, respectively, and $1,961,000 and $1,751,000 for the three-month period ended June 30, 2006 and 2005, respectively. The 2006 increase is primarily attributable to the Miikana acquisition.

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          The expenditures that will be necessary to execute our business plan are subject to numerous uncertainties, which may adversely affect our liquidity and capital resources. As of June 30, 2006, we have two product candidates, Panzem ® NCD and MKC-1, in Phase 2 clinical trials for cancer. We expect our R&D expenses to trend higher reflecting the costs of supporting multiple Phase 2 trials including the costs of securing clinical drug supply. Additionally, in the first quarter of 2006, ENMD-1198 commenced Phase 1 clinical trials in cancer. Completion of clinical trials may take several years or more, but the length of time generally varies substantially according to the type, complexity, novelty and intended use of a product candidate.
          We estimate that clinical trials of the type we generally conduct are typically completed over the following timelines:
         
    ESTIMATED  
    COMPLETION  
CLINICAL PHASE   PERIOD  
Phase I
  1 Year
Phase II
  1-2 Years
Phase III
  2-4 Years
          The duration and the cost of clinical trials may vary significantly over the life of a project as a result of differences arising during the clinical trial protocol, including, among others, the following:
    the number of patients that ultimately participate in the trial;
 
    the duration of patient follow-up that seems appropriate in view of the results;
 
    the number of clinical sites included in the trials; and
 
    the length of time required to enroll suitable patient subjects.
          We test our potential product candidates in numerous pre-clinical studies to identify indications for which they may be product candidates. We may conduct multiple clinical trials to cover a variety of indications for each product candidate. As we obtain results from trials, we may elect to discontinue clinical trials for certain product candidates or for certain indications in order to focus our resources on more promising product candidates or indications.
          Our proprietary product candidates also have not yet achieved FDA regulatory approval, which is required before we can market them as therapeutic products. In order to proceed to subsequent clinical trial stages and to ultimately achieve regulatory approval, the FDA must conclude that our clinical data establish safety and efficacy. Historically, the results from pre-clinical testing and early clinical trials have often not been predictive of results obtained in later clinical trials. A number of new drugs and biologics have shown promising results in clinical trials, but subsequently failed to establish sufficient safety and efficacy data to obtain necessary regulatory approvals.

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          An important element of our business strategy is to pursue the research and development of a range of product candidates for a variety of oncology and non-oncology indications. This allows us to diversify the risks associated with our research and development expenditures. As a result, we intend to pursue development of our existing product candidates internally or through development partnerships, as well as through the acquisition and subsequent development of promising candidates. The goal is to align our future capital requirements with multiple product candidates and to increase the likelihood that our future financial success is not substantially dependent on any one product candidate. To the extent we are unable to maintain a broad range of product candidates, our dependence on the success of one or a few product candidates would increase.
          Furthermore, our business strategy includes the option of entering into collaborative arrangements with third parties to complete the development and commercialization of our products. In the event that third parties take over the clinical trial process for one of our product candidates, the estimated completion date would largely be under the control of that third party rather than us. We cannot forecast with any degree of certainty which proprietary products or indications, if any, will be subject to future collaborative arrangements, in whole or in part, and how such arrangements would affect our capital requirements.
          As a result of the uncertainties discussed above, among others, we are unable to estimate the duration and completion costs of our research and development projects. Our inability to complete our research and development projects in a timely manner or our failure to enter into collaborative agreements, when appropriate, could significantly increase our capital requirements and could adversely impact our liquidity. These uncertainties could force us to seek additional, external sources of financing from time to time in order to continue with our business strategy. Our inability to raise additional capital, or to do so on terms reasonably acceptable to us, would jeopardize the future success of our business.
          Research and development expenses consist primarily of compensation and other expenses related to research and development personnel, research collaborations, costs associated with internal and contract pre-clinical testing and clinical trials of our product candidates, including the costs of manufacturing the product candidates, and facilities expenses. Research and development expenses increased to $8,269,000 in the six months ended June 30, 2006 from $8,192,000 for the corresponding period in 2005 and to $4,258,000 for the three months ended June 30, 2006 from $3,812,000 for the corresponding period in 2005. The 2006 expenses include Miikana research and development costs of $1,798,000 and $884,000 for the six and three-month periods, respectively. The 2006 R&D expenses reflect a small increase and also a shift in emphasis to a clinical focus. Expenditures during the three and six months ended June 30, 2006 were specifically impacted by the following:
    Outside Services — We utilize outsourcing to conduct our product development activities. Larger-scale small molecule synthesis, in vivo testing and data analysis are examples of the services that we outsource. In the three-month period ended June 30, 2006, EntreMed expended $801,000 on these activities versus $655,000 in the same 2005 period. For the six-month period ended June 30, 2006 outside services were $1,139,000, compared to $1,136,000 for the same 2005 period While the costs for the two periods were essentially the same, the 2006 expense includes $231,000 related to Miikana’s outside services. An offsetting decrease in expenses resulted from the absence of certain preclinical activities related to ENMD-1198, which is now in Phase 1 trials.

15


 

    Collaborative Research Agreements — EntreMed made payments to collaborators of $26,000 and $327,000 for the three months ended June 30, 2006 and 2005, respectively, and $142,000 and $432,000 for the six months ended June 30, 2006 and 2005, respectively. Our collaborative efforts are primarily directed towards further exploration of 2ME2 mechanism-of-action (MOA) and Panzem Ò non-oncology applications.
 
    Clinical Trial Costs — Clinical trial costs increased to $562,000 in the three months ended June 30, 2006, from $285,000 in the three-month period ended June 30, 2005. Clinical trial costs for the six-month period ended June 30, 2006 increased to $1,037,000 from $487,000 for the comparable 2005 period. The increase reflects the initiation of Phase 2 clinical trials for Panzem Ò NCD, in addition to $315,000 related to the initiation of Phase 2 clinical trials for MKC-1. Costs of such trials include the clinical site fees, monitoring costs and data management costs.
 
    Contract Manufacturing Costs — The costs of manufacturing the material used in clinical trials for our product candidates is reflected in contract manufacturing. These costs include bulk manufacturing, encapsulation and fill and finish services, and product release costs. Contract manufacturing costs totaled $758,000 for the three months ended June 30, 2006 and 2005. For the six-month period ended June 30, 2006 manufacturing costs decreased to $1,531,000 from $1,636,000 for the comparable 2005 period. Included in the 2006 amount is $177,000 related to the encapsulation of material for the Phase 2 trials for MKC-1. The 2006 decrease results from the timing of manufacturing activities.
     Also reflected in our 2006 research and development expenses for the three-month period ended June 30, 2006 are personnel costs of $984,000, patent costs of $197,000 and facility and related expenses of $407,000, including Miikana’s expenses of $230,000, $42,000 and $93,000, respectively. In the corresponding 2005 period, these expenses totaled $733,000, $206,000 and $338,000, respectively. For the six-month period ended June 30, 2006, personnel costs were $2,222,000, patent costs were $422,000 and facility and related expenses were $749,000, including Miikana’s expenses of $619,000, $88,000 and $113,000, respectively. In the corresponding 2005 period, these expenses totaled $1,468,000, $326,000 and $674,000, respectively.
      General and Administrative Expenses . General and administrative expenses include compensation and other expenses related to finance, business development and administrative personnel, professional services and facilities.
     General and administrative expenses increased to $1,943,000, including Miikana’s expenses of $164,000, in the three-month period ended June 30, 2006 from $1,339,000 in the corresponding 2005 period. For the six-month period, general and administrative expenses increased in 2006 to $3,759,000, including Miikana’s expenses of $353,000, from $2,599,000 for the corresponding 2005 period. In addition to Miikana’s general and administrative expenses, the 2006 increase relates to the recording of additional non-cash stock-based compensation, pursuant to the adoption of SFAS 123R, in the amount of $418,000 and $706,000 for the three and six-month periods, respectively.
      Investment income . Investment income increased by 110% in the three-month period ended June 30, 2006 to $570,000 from $272,000 in the corresponding 2005 and increased by 97% in the six-month period ended June 30, 2006 to $848,000 from $430,000 in the corresponding 2005 period as a result of higher yields on higher invested balances in interest bearing cash accounts and investments during the 2006 period.

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      Interest expense . Interest expense for the three and six-month periods ended June 30, 2006 was $43,000 and $91,000, respectively. There was no interest expense for the corresponding 2005 periods.
      Dividends on Series A convertible preferred stock . The Consolidated Statement of Operations for the three and six-month periods ended June 30, 2006 and 2005 reflect a dividend of $251,250 and $502,500, respectively, relating to Series A Convertible Preferred Stock held by Celgene pursuant to a Securities Purchase Agreement dated December 31, 2002. The holders of Series A Preferred Stock will accumulate dividends at a rate of 6% and will participate in dividends declared and paid on our common stock, if any. All accumulated dividends must be paid before any dividends may be declared or paid on the common stock. The Company has no plans to pay any dividends in the foreseeable future.
LIQUIDITY AND CAPITAL RESOURCES
     To date, we have been engaged primarily in research and development activities. As a result, we have incurred and expect to continue to incur operating losses for 2006 and the foreseeable future before we commercialize any products. Under the terms of the license agreements for 2ME2 and Celgene’s tubulin inhibitor program, we must be diligent in bringing potential products to market and may be required to make future milestone payments totaling approximately $850,000 and $25.25 million, respectively. In addition, pursuant to the MKC-1 license agreement with Roche, we may be required to make payments based upon the attainment of certain milestones. As a result of progress in our licensed clinical and preclinical programs, milestones requiring payments totaling $600,000 could be reached in 2006, and an additional milestone payment of $1,000,000 would be payable in 2007 if a lead compound under our license agreement with Celgene reached the IND stage. If we fail to comply with the milestones or fail to make any required sponsored research or milestone payment, we could face the termination of the relevant license agreement.
     Pursuant to the terms of the Miikana Merger Agreement, a purchase price adjustment of $2,000,000 is payable when one of the acquired preclinical programs advances to a Phase 1 clinical trial. The Aurora Kinase program could advance to the clinic in 2007. If this occurs, the $2,000,000 is payable in either cash or common stock, at our option.
     In February 2006, we raised gross proceeds of approximately $30 million through the sale of units consisting of warrants and shares of common stock in a private placement. At June 30, 2006, we had cash and short term investments of approximately $45 million with working capital of approximately $39 million.
     We invest our capital resources with the primary objective of capital preservation. As a result of trends in interest rates, we have invested in some securities with maturity dates of more than 90 days to enhance our investment yields. As such, some of our invested balances are classified as short-term investments rather than cash equivalents in our unaudited consolidated financial statements at June 30, 2006.

17


 

     To accomplish our business plans, we will be required to continue to conduct substantial development activities for some or all of our proposed products. The acquisition of Miikana Therapeutics in January 2006 provides an additional product pipeline, including MKC-1, a cell cycle regulator, which entered Phase 2 oncology trials in January 2006. In conjunction with the acquisition, we assumed certain separation obligations totaling approximately $500,000. Under our current operating plans, which include supporting two Phase 2 and one Phase 1 clinical trials for oncology compounds, we expect our 2006 results of operations to reflect a net loss of approximately $56 million which includes non-cash charges of approximately $29,500,000 associated with the Miikana asset acquisition and $1.4 million pursuant to the adoption of SFAS 123R. This projection is subject to judgment and estimation and could significantly change. We expect that the majority of our 2006 revenues will continue to be from royalties on the sale of Thalomid ® . Based on historical trend and analyst consensus for Thalomid ® sales in 2006, we believe we will begin recording royalty sharing revenues in the third quarter of 2006. We believe the 2006 total will exceed $5 million; however, there can be no assurance in this regard. In addition, under our licensing agreement with Oxford Biomedica, PLC and Oxford Biomedica (UK) Limited Oxford, we are entitled to receive payments upon the achievement of certain milestones. However, we do not control the drug development efforts of Oxford and have no control over when or whether such milestones will be reached. We do not believe that we will receive any developmental milestone payments under these agreements in 2006.
     Based on our assessment of our current capital resources coupled with anticipated inflows, in the absence of additional financing, we believe that we will have adequate resources to fund planned operations for more than twelve months. Our estimate may change, however, based on our decisions with respect to future clinical trials related to our three clinical drug candidates, the timing of receipt of milestone payments, developments in our business including the acquisition of additional intellectual property, other investments in new or complementary technology, and our success in executing our current business plan.
     To address our long-term capital needs we intend to continue to pursue strategic relationships that would provide resources for the further development of our product candidates. There can be no assurance, however, that these discussions will result in relationships or additional funding. 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. There can be no assurance that we will be successful in seeking additional capital.
INFLATION AND INTEREST RATE CHANGES
     Management does not believe that our working capital needs are sensitive to inflation and changes in interest rates.

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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
     The primary objective of our investment activities is to preserve our capital until it is required to fund operations while at the same time maximizing the income we receive from our investments without incurring investment market volatility risk. Our investment income is sensitive to the general level of U.S. interest rates. In this regard, changes in the U.S. interest rates affect the interest earned on our cash and cash equivalents. Due to the short-term nature of our cash and cash equivalent holdings, a 10% movement in market interest rates would not materially impact on the total fair market value of our portfolio as of June 30, 2006.
ITEM 4. CONTROLS AND PROCEDURES
     As of June 30, 2006, under the supervision and with the participation of the Company’s Chief Executive Officer (“CEO”) and the Chief Financial Officer (“CFO”), management has evaluated the effectiveness of the design and operation of the Company’s disclosure controls and procedures pursuant to Rule 13(a)-15 under the Securities and Exchange Act of 1934 the (“Exchange Act”). Based on that evaluation, the CEO and CFO concluded that, as of June 30, 2006, the Company’s disclosure controls and procedures were effective at the reasonable assurance level in timely alerting them to material information required to be included in the Company’s periodic SEC reports. Management’s assessment of the effectiveness of internal control over financial reporting is expressed at the level of reasonable assurance because a control system, no matter how well designed and operated, can provide only reasonable, but not absolute, assurance that the control system’s objectives will be met.
     There was no change in the Company’s internal control over financial reporting that occurred during the quarter ended June 30, 2006 that has materially affected or is reasonably likely to materially affect the Company’s internal control over financial reporting.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
     We are subject in the normal course of business to various legal proceedings in which claims for monetary or other damages may be asserted. Management does not believe such legal proceedings, except as otherwise disclosed herein, are material.
ITEM 1A. RISK FACTORS
     For information regarding factors that could affect the Company’s results of operations, financial condition and liquidity, see the risk factors discussion set forth in Item 1A of EntreMed’s Annual Report on Form 10-K for the fiscal year ended December 31, 2005 and the information under “Special Note Regarding Forward-Looking Statements” included in this report. There have been no material changes to our risk factors from those disclosed in our Annual Report on Form 10-K.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
     Not. Applicable.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
     Not applicable.

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ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
     (a) The Company’s annual meeting of stockholders was held on June 15, 2006 (the Annual Meeting).
     (b) Not applicable.
     (c) At the Annual Meeting, the stockholders considered and approved the following proposals:
     (i Election of Directors. The following sets forth the nominees who were elected Directors of the Company for the term expiring in the year indicated as well as the number of votes cast for, against, or withheld:
             
Year Term            
Expires   Name   Votes For   Votes Withheld
2009
  Michael M. Tarnow   68,676,660   1,139,708
2009
  Ronald Cape   68,653,079   1,163,289
     (ii) Approve an amendment to the Company’s Amended and Restated Certificate of Incorporation to increase the number of authorized shares of the Company’s common stock, $.01 par value, from 120,000,000 shares to 170,000,000 shares. This proposal received 67,955,394 votes in favor, 1,575,312 votes against, 285,662 abstentions and 0 broker non-votes.
     (iii) Approve an amendment to the Company’s 2001 Long-Term Incentive Plan increasing from 6,250,000 to 7,250,000 the number shares of Common Stock reserved for issuance and modify the limit on individual awards. This proposal received 37,953,004 votes in favor, 2,217,755 votes against, 123,941 abstentions, and 29,521,668 broker non-votes.
     (iv) Ratification of Appointment of Ernst & Young LLP. At the Annual Meeting, stockholders approved and ratified the selection of Ernst & Young LLP as the independent auditors. The proposal received 69,381,935 votes in favor, 381,150 votes against, 53,283 abstentions, and 0 broker non-votes.
     (v) Celgene Corporation has the right to one vote for each share of Common Stock into which its 3,350,000 shares of Convertible Preferred Stock are convertible, which is currently 16,750,000 shares. The “votes for” numbers above include Celgene’s votes.
ITEM 5. OTHER INFORMATION
     Not applicable.

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ITEM 6. EXHIBITS
     Exhibits
    3.1   Amended and Restated Certificate of Incorporation
 
  10.1   2001 Long-Term Incentive Plan, as amended
 
  31.1   Rule 13a-14(a) Certification of President and Chief Executive Officer
 
  31.2   Rule 13a-14(a) Certification of Chief Financial Officer
 
  32.1   Section 1350 Certification of Chief Executive Officer
 
  32.2   Section 1350 Certification of Chief Financial Officer

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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
         
 
  ENTREMED, INC.    
 
  (Registrant)    
 
       
Date: August 9, 2006
  /s/ James S. Burns    
 
 
 
James S. Burns
   
 
  President and Chief Executive Officer    
 
       
Date: August 9, 2006
  /s/ Dane R. Saglio    
 
 
 
Dane R. Saglio
   
 
  Chief Financial Officer    

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EXHIBIT INDEX
  3.1   Amended and Restated Certificate of Incorporation
 
10.1   2001 Long-Term Incentive Plan, as amended
 
31.1   Rule 13a-14(a) Certification of President and Chief Executive Officer
 
31.2   Rule 13a-14(a) Certification of Chief Financial Officer
 
32.1   Section 1350 Certification of Chief Executive Officer
 
32.2   Section 1350 Certification of Chief Financial Officer

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Exhibit 3.1
AMENDED AND RESTATED
CERTIFICATE OF INCORPORATION
OF
ENTREMED, INC.
PURSUANT TO SECTIONS 242 AND 245
OF THE GENERAL CORPORATION LAW OF DELAWARE
      WHEREAS , EntreMed, Inc. (the “Corporation”) was formed on September 18, 1991 by the filing of a Certificate of Incorporation (the “Certificate”) with the Secretary of State of the State of Delaware pursuant to Section 103 of the General Corporation Law;
      WHEREAS, the Corporation wishes to amend and restate the Certificate in its entirety, and the undersigned, being the President and Chief Operating Officer of the Corporation, has been duly authorized to execute, acknowledge and deliver this amendment and restatement of the Certificate on behalf of the Corporation; and
      WHEREAS, the undersigned hereby certifies that the foregoing recitals are true and correct and that this Amended and Restated Certificate of Incorporation has been duly adopted by all necessary corporate action in accordance with Sections 242 and 245 of the General Corporation Law of Delaware;
      NOW THEREFORE, the Certificate is amended and restated in its entirety as follows:
I.
     The name of the corporation is: ENTREMED, INC. (hereinafter the “Corporation”).
II.
     The address of the Corporation’s registered office in the State of Delaware is Corporation Trust Center, 1209 Orange Street, Wilmington, Delaware 19801, County of New Castle and the name of the Corporation’s registered agent at such address is The Corporation Trust Company.
III.
     The purpose of the Corporation is to engage in any lawful act or activity for which corporations may be organized under the General Corporation Law of the State of Delaware.
IV.
     The total number of shares of capital stock which the Corporation is authorized to issue is One Hundred Seventy Five Million (175,000,000) divided into two classes as follows:

 


 

     (A)  Common Stock . One Hundred Seventy Million (170,000,000) shares of common stock, $.01 par value per share (“Common Stock”), the holder of which shall be entitled to one vote for each share on all matters required or permitted to be voted on by stockholders of the Corporation, and
     (B)  Preferred Stock . Five Million (5,000,000) shares of preferred stock, $1.00 par value per share (“Preferred Stock”).
           Authorization for Series of Preferred Stock . The Board of Directors is hereby expressly authorized to provide for, designate and issue, out of the authorized but unissued shares of Preferred Stock, one or more series of Preferred Stock, subject to the terms and conditions set forth herein. Before any shares of any such series are issued, the Board of Directors shall fix, and hereby is expressly empowered to fix, by resolution or resolutions, the following provisions of the shares of any such series (within the limits and restrictions of any resolutions adopted by it designating any other series of preferred stock):
               (1) the designation of such series, the number of shares to constitute such series and the stated value thereof, if different from the par value thereof;
               (2) whether the shares of such series shall have voting rights or powers, in addition to any voting rights required by law, and, if so, the terms of such voting rights or powers, which may be full or limited;
               (3) the dividends, if any, payable on such series, whether any such dividends shall be cumulative, and, if so, from what dates, the conditions and dates upon which such dividends shall be payable, the preference or relation which such dividends shall bear to the dividends payable on any shares of stock of any other class or series;
               (4) whether the shares of such class or series shall be subject to redemption by the Corporation, and, if so, the times, prices and other conditions of such redemption;
               (5) the amount or amounts payable upon shares of such class or series upon, and the rights of the holders of such class or series in the voluntary or involuntary liquidation, dissolution or winding up, or upon any distribution of the assets, of the Corporation;
               (6) whether the shares of such class or series shall be subject to the operation of a retirement or sinking fund and, if so, the extent to and manner in which any such retirement or sinking fund shall be applied to the purchase or redemption of the shares of such class or series for retirement or other corporate purposes and the terms and provisions relative to the operation thereof;
               (7) whether the shares of such class or series shall be convertible into, or exchangeable for, shares of stock of any other class or series of any other securities and, if so, the price or prices or the rate or rates of conversion or

2


 

exchange and the method, if any, of adjusting the same, and any other terms and conditions of conversion or exchange;
               (8) the limitations and restrictions, if any, to be effective while any shares of such class or series are outstanding upon the payment of dividends or the making of other distributions on, and upon the purchase, redemption or other acquisition by the Corporation of, the Common Stock or shares of stock of any other class or series;
               (9) the conditions or restrictions, if any, to be effective while any shares of such class or series are outstanding upon the creation of indebtedness of the Corporation or upon the issue of any additional stock, including additional shares of such class or series or of any other class or series; and
               (10) any other powers, designations, preferences and relative, participating, optional or other special rights, and any qualifications, limitations or restrictions thereof.
          The powers, designations, preferences and relative, participating, optional or other special rights of each series of Preferred Stock, and the qualifications, limitations or restrictions thereof, if any, may differ from those of any and all other series at any time outstanding. The Board of Directors is hereby expressly authorized from time to time to increase (but not above the total number of authorized shares of Preferred Stock) or decrease (but not below the number of shares thereof then outstanding) the number of shares of stock of any series of Preferred Stock designated to any one or more series of Preferred Stock pursuant to this Section B of Article IV.
V.
     To the fullest extent permitted by the General Corporation Law of the State of Delaware, as the same presently exists or may hereafter be amended, no director of the Corporation shall be liable to the Corporation or any of its stockholders for monetary damages for breach of fiduciary duty as a director.
VI.
      Terms of Directors . The number of Directors of the Corporation shall be fixed by resolution duly adopted from time to time by the Board of Directors. The Directors shall be classified, with respect to the term for which they hold office, into three classes, as nearly equal in number as possible. The initial Class I Director shall serve for a term expiring at the annual meeting of stockholders to be held in 1998, the initial Class II Directors shall serve for a term expiring at the annual meeting of stockholders to be held in 1999, and the initial Class III Directors shall serve for a term expiring at the annual meeting of stockholders to be held in 2000. At each annual meeting of stockholders, the successor or successors of the class of Directors whose term expires at that meeting shall be elected by a plurality of the votes cast at such meeting and shall hold office for a term expiring at the annual meeting of stockholders held in the third year following the year of their election. The Directors elected to each class shall hold office until their successors are duly elected and qualified or until their earlier resignation or removal.

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      Vacancies . Any and all vacancies in the Board of Directors, however occurring, including, without limitation, by reason of an increase in size of the Board of Directors, or the death, resignation, disqualification or removal of a Director, shall be filled solely by the affirmative vote of a majority of the remaining Directors then in office, even if less than a quorum of the Board of Directors. Any Director appointed in accordance with the preceding sentence shall hold office until the annual meeting of stockholders at which the class of directors for which he or she has been chosen is elected and until such Director’s successor shall have been duly elected and qualified or until his or her earlier resignation or removal. When the number of Directors is increased or decreased, the Board of Directors shall determine the class or classes to which the increased or decreased number of Directors shall be appointed so as to maintain each class as nearly equal in number as possible; provided, however, that no decrease in the number of Directors shall shorten the term of any incumbent Director.
     The following provisions are inserted for the management of the business and for the conduct of the affairs of the Corporation, and for further definition, limitation and regulation of the powers of the Corporation and of its directors and stockholders:
  (1)   The election of directors need not be by written ballot, unless the by-laws so provide.
 
  (2)   The Board of Directors shall have power without the assent or vote of the stockholders to make, alter, amend, change, add to or repeal the By-Laws of the Corporation.
VII.
     The Corporation shall indemnify and advance expenses to the fullest extent permitted by Section 145 of the General Corporation Law of Delaware, as amended from time to time, each person who is or was a director or officer of the Corporation and the heirs, executors and administrators of such a person.
VIII.
     The Corporation reserves the right to amend, alter, change or repeal any provision contained in this Certificate of Incorporation in the manner now or hereafter prescribed by law, and all rights and powers conferred herein on stockholders, directors and officers are subject to this reserved power.
IX.
     This Amended and Restated Certificate of Incorporation, which restates and integrates and further amends the provisions of the Corporation’s Certificate of Incorporation as heretofore amended or supplemented, has been duly adopted by the board of directors and the stockholders of the Corporation in accordance with the provisions of Sections 242 and 245 of the General Corporation Law of the State of Delaware.

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      IN WITNESS WHEREOF , the Corporation has caused this Amended and Restated Certificate of Incorporation to be duly executed and attested by its duly authorized officers this 19th day of June, 2006.
         
  ENTREMED, INC.
 
 
  By:   /s/ James S. Burns    
    President and Chief Operating Officer   
       
 
[Corporate Seal]
ATTEST:
         
By:
       
 
       
 
  Secretary    

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Exhibit  10.1

ENTREMED, INC.

2001 LONG-TERM INCENTIVE PLAN, AS AMENDED

 
1. PURPOSE AND TYPES OF AWARDS

      The purpose of the 2001 Long-Term Incentive Plan (“Plan”) is to promote the long-term growth and profitability of the Corporation by: (i) providing key people with incentives to improve stockholder value and to contribute to the growth and financial success of the Corporation and (ii) enabling the Corporation to attract, retain and reward the best-available persons.

      The Plan permits the granting of stock options (including incentive stock options qualifying under Code section 422 and nonqualified stock options), stock appreciation rights, restricted or unrestricted stock awards, phantom stock, performance awards, or any combination of the foregoing.

 
2. DEFINITIONS

      Under this Plan, except where the context otherwise indicates, the following definitions apply:

      (a)  “Administrator” shall have the meaning set forth in Section 3(a).

      (b)  “Affiliate” means a corporation, partnership, business trust, limited liability company or other form of business organization at least a majority of the total combined voting power of all classes of stock or other equity interests of which is owned by the Corporation, either directly or indirectly, and any other entity designated by the Administrator in which the Corporation has a significant interest.

      (c)  “Award” shall mean any stock option, stock appreciation right, stock award, phantom stock award, or performance award.

      (d)  “Board” shall mean the Board of Directors of the Corporation.

      (e)  “Code” shall mean the Internal Revenue Code of 1986, as amended, and any regulations promulgated thereunder.

      (f)  “Common Stock” shall mean shares of common stock of the Corporation, $.01 par value.

      (g)  “Corporation” shall mean EntreMed, Inc. and any successor thereto.

      (h)  “Exchange Act” shall mean the Securities Exchange Act of 1934, as amended.

      (i)  “Fair Market Value” of a share of the Corporation’s Common Stock for any purpose on a particular date shall mean the last reported sale price per share of Common Stock, regular way, on such date or, in case no such sale takes place on such date, the average of the closing bid and asked prices, regular way, in either case as reported in the principal consolidated transaction reporting system with respect to securities listed or admitted to trading on a national securities exchange or included for quotation on the Nasdaq-National Market, or if the Common Stock is not so listed or admitted to trading or included for quotation, the last quoted price, or if the Common Stock is not so quoted, the average of the high bid and low asked prices, regular way, in the over-the-counter market, as reported by the National Association of Securities Dealers, Inc. Automated Quotation System or, if such system is no longer in use, the principal other automated quotations system that may then be in use or, if the Common Stock is not quoted by any such organization, the average of the closing bid and asked prices, regular way, as furnished by a professional market maker making a market in the Common Stock as selected in good faith by the Administrator or by such other source or sources as shall be selected in good faith by the Administrator. If, as the case may be, the relevant date is not a trading day, the determination shall be made as of the next preceding trading day. As used herein, the term “trading day” shall mean a day on which public trading of securities occurs and is reported in the principal consolidated reporting system referred to above, or if the Common Stock is not listed or admitted to


 

trading on a national securities exchange or included for quotation on the Nasdaq-National Market, any business day. In all events, Fair Market Value shall be determined pursuant to a method that complies with Section 409A of the Code.

      (j) ‘ ‘Grant Agreement” shall mean a written document memorializing the terms and conditions of an Award granted pursuant to the Plan and shall incorporate the terms of the Plan.

      (k)  “Participants” shall have the meaning set forth in Section 5.

      (l)  “Parent” shall mean a corporation, whether nor or hereafter existing, within the meaning of the definition of “parent corporation” provided in Code section 424(e), or any successor thereto.

      (m)  “Performance Goals” shall mean performance goals established by the Administrator which may be based on one or more business criteria selected by the Administrator that apply to an individual or group of individuals, a business unit, or the Corporation and/or one or more of its Affiliates either separately or together, over such performance period as the Administrator may designate, including, but not limited to, business criteria based on operating income, earnings or earnings growth, sales, return on assets, equity or investment, regulatory compliance, satisfactory internal or external audits, improvement of financial ratings, achievement of balance sheet or income statement objectives, or any other objective goals established by the Administrator, and may be absolute in their terms or measured against or in relationship to other companies comparably, similarly or otherwise situated.

      (n)  “Subsidiary” and “Subsidiaries” shall mean only a corporation or corporations, whether now or hereafter existing, within the meaning of the definition of “subsidiary corporation” provided in section 424(f) of the Code, or any successor thereto.

      (o)  “Ten-Percent Stockholder” shall mean a Participant who (applying the rules of Code section 424(d)) owns stock possessing more than 10% of the total combined voting power or value of all classes of stock or interests of the Corporation or a Parent or Subsidiary of the Corporation.

 
3. ADMINISTRATION

      (a)  Administration of the Plan. The Plan shall be administered by the Board or by such committee or committees as may be appointed by the Board from time to time (the Board, committee or committees hereinafter referred to as the “Administrator”). Notwithstanding the foregoing, the Administrator may delegate to the Chief Executive Officer of the Corporation the power to administer this Plan and have the full authority of the Administrator hereunder with respect to Awards granted to specified Participants or groups of Participants.

      (b)  Powers of the Administrator. The Administrator shall have all the powers vested in it by the terms of the Plan, such powers to include authority, in its sole and absolute discretion, to grant Awards under the Plan, prescribe Grant Agreements evidencing such Awards and establish programs for granting Awards.

      (c) The Administrator shall have full power and authority to take all other actions necessary to carry out the purpose and intent of the Plan, including, but not limited to, the authority to: (i) determine the eligible persons to whom, and the time or times at which Awards shall be granted; (ii) determine the types of Awards to be granted; (iii) determine the number of shares to be covered by or used for reference purposes for each Award; (iv) impose such terms, limitations, restrictions and conditions upon any such Award as the Administrator shall deem appropriate, including, but not limited to, whether a stock option shall be an incentive stock option or a nonqualified stock option, any exceptions to nontransferability, any Performance Goals applicable to Awards, any provisions relating to vesting, any circumstances in which the Awards would terminate, the period during which Awards may be exercised, and the period during which Awards shall be subject to restrictions; (v) modify, amend, extend or renew outstanding Awards, accept the surrender of outstanding Awards and substitute new Awards, or specify a lower or higher exercise price, or a longer or shorter term, for any substituted Awards than the surrendered Awards, or impose any other provisions that are


 

authorized by this Plan (provided however, that, except as provided in Section 7(g)(i) of the Plan, any modification that would materially adversely affect any outstanding Award shall not be made without the consent of the holder); (vi) accelerate, extend, or otherwise change the time in which an Award may be exercised or becomes payable and to waive or accelerate the lapse, in whole or in part, of any restriction or condition with respect to such Award, including, but not limited to, any restriction or condition with respect to the vesting or exercisability of an Award due to termination of any Participant’s employment or other relationship with the Corporation or an Affiliate; and (vii) establish objectives and conditions, if any, for earning Awards and determining whether Awards will be paid after the end of a performance period.

      (d) In making these determinations, the Administrator may take into account the nature of the services rendered or to be rendered by the Award recipients, their present and potential contributions to the success of the Corporation and its Affiliates, and such other factors as the Administrator in its discretion shall deem relevant. Subject to the provisions of the Plan, the Administrator shall have full power and authority, in its sole and absolute discretion, to administer and interpret the Plan and to adopt and interpret such rules, regulations, agreements, guidelines and instruments for the administration of the Plan and for the conduct of its business as the Administrator deems necessary or advisable.

      (e)  Non-Uniform Determinations. The Administrator’s determinations under the Plan (including, without limitation, determinations of the persons to receive Awards, the form, amount and timing of such Awards, the terms and provisions of such Awards and the Grant Agreements evidencing such Awards) need not be uniform and may be made by the Administrator selectively among persons who receive, or are eligible to receive, Awards under the Plan, whether or not such persons are similarly situated.

      (f)  Limited Liability. To the maximum extent permitted by law, no member of the Administrator shall be liable for any action taken or decision made in good faith relating to the Plan or any Award thereunder.

      (g)  Effect of Administrator’s Decision. All actions taken and decisions and determinations made by the Administrator on all matters relating to the Plan pursuant to the powers vested in it hereunder shall be in the Administrator’s sole and absolute discretion and shall be conclusive and binding on all parties concerned, including the Corporation, its stockholders, any Participants and any other employee, consultant, or director of the Corporation, and their respective successors in interest.

 
4. SHARES AVAILABLE FOR THE PLAN

      (a)  Maximum Issuable Shares. Subject to adjustments as provided in Section 7(f), the shares of Common Stock that may be issued with respect to Awards granted under the Plan shall not exceed an aggregate of 7,250,000 shares of Common Stock. The Corporation shall reserve such number of shares for Awards under the Plan, subject to adjustments as provided in Section 7(f). If any Award, or portion of an Award, under the Plan expires or terminates unexercised, becomes unexercisable or is forfeited or otherwise terminated, surrendered or canceled as to any shares, or if any shares of Common Stock are surrendered to the Corporation in connection with any Award (whether or not such surrendered shares were acquired pursuant to any Award), the shares subject to such Award and the surrendered shares shall thereafter be available for further Awards under the Plan; provided, however, that any such shares that are surrendered to the Corporation in connection with any Award or that are otherwise forfeited after issuance shall not be available for purchase pursuant to incentive stock options intended to qualify under Code section 422.

      (b)  Maximum Awards. Subject to adjustments as provided in Section 7(f) and Section 7(g)(ii), the maximum number of shares of Common Stock subject to Awards of any combination that may be granted during any calendar year of the Corporation to any one individual under this Plan shall be limited to 250,000; provided, however that Awards to an individual not previously an employee, as an inducement material to the individual’s entering into employment with the Corporation, shall be limited to 500,000.


 

 
5. PARTICIPATION

      (a) Participation in the Plan shall be open to all persons who are at the time of the grant of an Award employees (including persons who may become employees), officers, directors, and consultants of the Corporation, or of any Affiliate of the Corporation, as may be selected by the Administrator from time to time. A Participant who has been granted an Award may, if he or she is otherwise eligible, be granted additional Awards if the Administrator so determines.

 
6. AWARDS

      The Administrator, in its sole discretion, establishes the terms of all Awards granted under the Plan. All Awards shall be subject to the terms and conditions provided in the Grant Agreement.

      (a)  Stock Options. The Administrator may from time to time grant to eligible Participants Awards of incentive stock options as that term is defined in Code section 422 or nonqualified stock options; provided, however, that Awards of incentive stock options shall be limited to employees of the Corporation or of any Parent or Subsidiary of the Corporation. Options intended to qualify as incentive stock options under Code section 422 must have an exercise price at least equal to Fair Market Value on the date of grant or at least 110% of Fair Market Value in the case of a Ten-Percent Stockholder, but nonqualified stock options may be granted with an exercise price less than Fair Market Value. No stock option shall be an incentive stock option unless so designated by the Administrator at the time of grant and such designation is reflected in the Grant Agreement evidencing such stock option.

      (b)  Stock Appreciation Rights. The Administrator may from time to time grant to eligible Participants Awards of Stock Appreciation Rights (“SARs”). A SAR may be exercised in whole or in part as provided in the applicable Grant Agreement and entitles the Participant to receive, subject to the provisions of the Plan and the Grant Agreement, a payment having an aggregate value equal to the product of (i) the excess of (A) the Fair Market Value on the exercise date of one share of Common Stock over (B) the base price per share specified in the Grant Agreement, multiplied by (ii) the number of shares covered by the SAR, or portion thereof, which is exercised. Payment by the Corporation of the amount receivable upon any exercise of a SAR may be made by the delivery of Common Stock or cash, or any combination of Common Stock and cash, as specified in the Grant Agreement. If upon settlement of the exercise of a SAR a Participant is to receive a portion of such payment in shares of Common Stock, the number of shares shall be determined by dividing such portion by the Fair Market Value of a share of Common Stock on the exercise date. No fractional shares shall be used for such payment and the Administrator shall determine whether cash shall be given in lieu of such fractional shares or whether such fractional shares shall be eliminated.

      (c)  Stock Awards. The Administrator may from time to time grant restricted or unrestricted stock Awards to eligible Participants in such amounts, on such terms and conditions (which terms and conditions may condition the vesting or payment of Stock Awards on the achievement of one or more Performance Goals), and for such considerations, including no consideration or such minimum consideration as may be required by law, as it shall determine.

      (d)  Phantom Stock. The Administrator may from time to time grant Awards to eligible Participants denominated in stock-equivalent units (“Phantom Stock”) in such amounts and on such terms and conditions as it shall determine, which terms and conditions may condition the vesting or payment of Phantom Stock on the achievement of one or more Performance Goals. Phantom Stock units granted to a Participant shall be credited to a bookkeeping reserve account solely for accounting purposes and shall not require a segregation of any of the Corporation’s assets. An Award of Phantom Stock may be settled in Common Stock, in cash, or in a combination of Common Stock and cash, as specified in the Grant Agreement. Except as otherwise provided in the applicable Grant Agreement, the Participant shall not have the rights of a stockholder with respect to any shares of Common Stock represented by a Phantom Stock unit solely as a result of the grant of a Phantom Stock unit to the Participant.


 

      (e)  Performance Awards. The Administrator may, in its discretion, grant performance Awards, which become payable on account of attainment of one or more Performance Goals established by the Administrator. Performance Awards may be paid by the delivery of Common Stock or cash, or any combination of Common Stock and cash, as specified in the Grant Agreement.

 
7. MISCELLANEOUS

      (a)  Investment Representations. The Administrator may require each person acquiring shares of Common Stock pursuant to Awards hereunder to represent to and agree with the Corporation in writing that such person is acquiring the shares without a view to distribution thereof. The certificates for such shares may include any legend that the Administrator deems appropriate to reflect any restrictions on transfer. All certificates for shares issued pursuant to the Plan shall be subject to such stock transfer orders and other restrictions as the Administrator may deem advisable under the rules, regulations and other requirements of the Securities and Exchange Commission, any stock exchange upon which the Common Stock is then listed or interdealer quotation system upon which the Common Stock is then quoted, and any applicable federal or state securities laws. The Administrator may place a legend or legends on any such certificates to make appropriate reference to such restrictions.

      (b)  Compliance with Securities Law. Each Award shall be subject to the requirement that if, at any time, counsel to the Corporation shall determine that the listing, registration or qualification of the shares subject to such an Award upon any securities exchange or interdealer quotation system or under any state or federal law, or the consent or approval of any governmental or regulatory body, or that the disclosure of nonpublic information or the satisfaction of any other condition is necessary in connection with the issuance or purchase of shares under such an Award, such Award may not be exercised, in whole or in part, unless such satisfaction of such condition shall have been effected on conditions acceptable to the Administrator. Nothing herein shall be deemed to require the Corporation to apply for or to obtain such listing, registration or qualification, or to satisfy such condition.

      (c)  Withholding of Taxes. Participants and holders of Awards shall pay to the Corporation or its Affiliate, or make provision satisfactory to the Administrator for payment of, any taxes required to be withheld in respect of Awards under the Plan no later than the date of the event creating the tax liability. The Corporation or its Affiliate may, to the extent permitted by law, deduct any such tax obligations from any payment of any kind otherwise due to the Participant or holder of an Award. In the event that payment to the Corporation or its Affiliate of such tax obligations is made in shares of Common Stock, such shares shall be valued at Fair Market Value on the applicable date for such purposes.

      (d)  Loans. The Corporation or its Affiliate may make or guarantee loans to Participants to assist Participants in exercising Awards and satisfying any withholding tax obligations.

      (e)  Transferability. Except as otherwise determined by the Administrator or provided in a Grant Agreement, no Award granted under the Plan shall be transferable by a Participant except by will or the laws of descent and distribution. Unless otherwise determined by the Administrator in accordance with the provisions of the immediately preceding sentence, during the lifetime of the Participant, the Award may be exercised only by the Participant or, during the period the Participant is under a legal disability, by the Participant’s guardian or legal representative. Except as provided above, the Award may not be assigned, transferred, pledged, hypothecated or disposed of in any way (whether by operation of law or otherwise) and shall not be subject to execution, attachment or similar process.

      (f)  Capital Adjustments. In the event of any change in the outstanding Common Stock by reason of any stock dividend, split-up, stock split, recapitalization, reclassification, combination or exchange of shares, merger, consolidation, liquidation or the like, the Administrator may, in its discretion, provide for a substitution for or adjustment in (i) the number and class of shares of Common Stock subject to outstanding Awards, (ii) the exercise price of Stock Options and the base price upon which payments under SARs are determined, (iii) the aggregate number and class of Shares for which Awards thereafter may be made under


 

this Plan, (iv) the maximum number of shares of Common Stock with respect to which a Participant may be granted Awards during the period specified in Section 4(b) hereof.

      (g)  Modification, Substitution of Awards.

        (i) Subject to the terms and conditions of this Plan, the Administrator may modify the terms of any outstanding Awards; provided, however, that no modification of an Award shall, without the consent of the Participant, alter or impair any of the Participant’s rights or obligations under such Award.
 
        (ii) Anything contained herein to the contrary notwithstanding, Awards may, at the discretion of the Administrator, be granted under this Plan in substitution for stock options and other awards covering capital stock of another corporation which is merged into, consolidated with, or all or a substantial portion of the property or stock of which is acquired by, the Corporation or one of its Affiliates. The terms and conditions of the substitute Awards so granted may vary from the terms and conditions set forth in this Plan to such extent as the Administrator may deem appropriate in order to conform, in whole or part, to the provisions of the awards in substitution for which they are granted. Such substitute Awards granted hereunder shall not be counted toward the limit imposed by Section 4(b) hereof, except to the extent it is determined by the Administrator that counting such Awards is required in order for Awards hereunder to be eligible to qualify as “performance-based compensation” within the meaning of Section 162(m) of the Code.

      (h)  Foreign Employees. Without amendment of this Plan, the Administrator may grant Awards to Participants who are subject to the laws of foreign countries or jurisdictions on such terms and conditions different from those specified in this Plan as may in the judgement of the Administrator be necessary or desirable to foster and promote achievement of the purposes of this Plan. The Administrator may make such modifications, amendments, procedures, sub-plans and the like as may be necessary or advisable to comply with provisions of laws of other countries or jurisdictions in which the Corporation or any of its Affiliates operate or have employees.

      (i)  Termination, Amendment and Modification of the Plan. The Board may amend, alter or terminate the Plan, or portion thereof, at any time.

      (j)  Non-Guarantee of Employment or Service. Nothing in the Plan or in any Grant Agreement shall confer on an individual any legal or equitable right against the Corporation, any Affiliate or the Administrator, except as expressly provided in the Plan or the Grant Agreement. Nothing in the Plan or in any Grant Agreement thereunder shall (i) constitute inducement, consideration, or contract for employment or service between an individual and the Corporation or any Affiliate; (ii) confer any right on an individual to continue in the service of the Corporation or any Affiliate; or (iii) shall interfere in any way with the right of the Corporation or any Affiliate to terminate such service at any time with or without cause or notice, or to increase or decrease compensation for such service.

      (k)  Other Employee Benefits. Except as to plans that by their terms include such amounts as compensation, the amount of any compensation deemed to be received by a Participant as a result of the exercise of an Award or the sale of shares received upon such exercise will not constitute compensation with respect to which any other employee benefits of such Participant are determined, including, without limitation, benefits under any bonus, pension, profit-sharing, life insurance or salary continuation plan, except as otherwise specifically determined by the Administrator.

      (l)  No Trust or Fund Created. Neither the Plan nor any Award shall create or be construed to create a trust or separate fund of any kind or a fiduciary relationship between the Corporation and a Participant or any other person. To the extent that any Participant or other person acquires a right to receive payments from the Corporation pursuant to an Award, such right shall be no greater than the right of any unsecured general creditor of the Corporation.

      (m)  Governing Law. The validity, construction and effect of the Plan, of Grant Agreements entered into pursuant to the Plan, and of any rules, regulations, determinations or decisions made by the Administrator relating to the Plan or such Grant Agreements, and the rights of any and all persons having or claiming to have


 

any interest therein or thereunder, shall be determined exclusively in accordance with applicable federal laws and the laws of the State of Delaware without regard to its conflict of laws principles.

      (n)  Effective Date, Termination Date. The Plan is effective as of May 14, 2001, the date on which the Plan was adopted by the Board, subject to the approval of the stockholders of the Corporation within twelve months of such effective date. No Award shall be granted under the Plan after the close of business on May 14, 2011. Subject to other applicable provisions of the Plan, all Awards made under the Plan prior to such termination of the Plan shall remain in effect until such Awards have been satisfied or terminated in accordance with the Plan and the terms of such Awards.

      (m)  Section 409 A. Effective January 1, 2005 and notwithstanding any other provision of this Plan to the contrary, to the extent any Award (or modification of an Award) under this Plan results in the deferral of compensation (for purposes of Section 409A of the Code), the terms and conditions of the Award shall comply with Section 409A of the Code.

Approved by the Stockholders: June 15, 2001

Date Amendment No. 1 Approved by Stockholders: June 6, 2002
Date Amendment No. 2 Approved by Stockholders: June 18, 2003
Date Amendment No. 3 Approved by Stockholders: June 16, 2004
Date Amendment No. 4 Approved by Stockholders: July 28, 2005
Date Amendment No. 4 Approved by Stockholders: June 15, 2006
 

Exhibit 31.1
CERTIFICATION OF PRESIDENT AND CHIEF EXECUTIVE OFFICER
I, James S. Burns, certify that:
1. I have reviewed this quarterly report on Form 10-Q of EntreMed, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: August 9, 2006
     
/s/ James S. Burns
   
 
James S. Burns
   
President and Chief Executive Officer
   

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Exhibit 31.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER
I, Dane R. Saglio, certify that:
1. I have reviewed this quarterly report on Form 10-Q of EntreMed, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: August 9, 2006
     
/s/ Dane R. Saglio
   
 
Dane R. Saglio
   
Chief Financial Officer
   

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Exhibit 32.1
CERTIFICATION BY CHIEF EXECUTIVE OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
     In connection with the Quarterly Report of EntreMed, Inc. (the “Company”) on Form 10-Q as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, James S. Burns, as Chief Executive Officer of the Company, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, to the best of my knowledge, that:
  (1)   The Report fully complies with the requirements of section 13(a) of the Securities Exchange Act of 1934; and
 
  (2)   The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company for the dates and periods covered by the Report.
     The foregoing certification is being furnished solely pursuant to 18 U.S.C. Section 1350 and is not being filed as part of the Report or as a separate disclosure document.
         
 
  /s/ James S. Burns    
August 9, 2006
 
 
James S. Burns
   
 
  President and CEO    

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Exhibit 32.2
CERTIFICATION BY CHIEF FINANCIAL OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
     In connection with the Quarterly Report of EntreMed, Inc. (the “Company”) on Form 10-Q as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Dane R. Saglio, as Chief Financial Officer of the Company, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, to the best of my knowledge, that:
  (1)   The Report fully complies with the requirements of section 13(a) of the Securities Exchange Act of 1934; and
 
  (2)   The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company for the dates and periods covered by the Report.
     The foregoing certification is being furnished solely pursuant to 18 U.S.C. Section 1350 and is not being filed as part of the Report or as a separate disclosure document.
         
 
  /s/ Dane R. Saglio    
August 9, 2006
 
 
Dane R. Saglio
   
 
  Chief Financial Officer    

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