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CASI Pharmaceuticals, Inc (DE) - Quarter Report: 2003 September (Form 10-Q)

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FORM 10-Q

SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20459

[x]      QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2003

[  ]      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
incorporation or organization)
  (I.R.S. Employer Identification No.)
 
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      X           NO           

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Act). YES      X           NO           

As of November 6, 2003, 36,919,141 shares of the Company’s common stock, $.01 par value, were outstanding.


 

ENTREMED, INC.

Table of Contents

     
PART I. FINANCIAL INFORMATION   PAGE
 
Item 1 — Financial Statements    
 
Consolidated Balance Sheets as of September 30, 2003 and December 31, 2002   3
 
Consolidated Statements of Operations for the Three Months Ended
September 30, 2003 and 2002, and the Nine Months Ended September 30, 2003 and September 30, 2002
  4
 
Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2003 and 2002   5
 
Notes to Consolidated Financial Statements   6
 
Item 2 — Management’s Discussion and Analysis of Financial Condition and Results of Operations   9
 
Item 3 — Quantitative and Qualitative Disclosures About Market Risk   14
 
Item 4 — Disclosure Controls and Procedures   15
 
Part II. OTHER INFORMATION    
 
Item 1 — Legal Proceedings   15
 
Item 2 — Changes in Securities   15
 
Item 3 — Defaults upon Senior Securities   15
 
Item 4 — Submission of Matters to Vote of Security Holders   15
 
Item 5 — Other Information   16
 
Item 6 — Exhibits and Reports on Form 8-K   16
 
SIGNATURES   17

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This report contains and incorporates by reference certain forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by forward-looking words such as “may,” “will,” “expect,” “anticipate” or similar words. These forward-looking statements include, among others, statements regarding the timing of our clinical trials and the expected increases in our expenses.

Our forward-looking statements are based on information available to us today, and we will not update these statements. Our actual results may differ significantly from those discussed in our forward-looking statements due to, among other factors, our history of operating losses and anticipation of future losses; our ability to satisfy our obligations under existing collaborations and to enter into new collaborations; uncertainties relating to our technological approach; uncertainty of our product candidate development; our need for additional capital and uncertainty of additional funding; our dependence on collaborators and licensees; intense competition and rapid technological change in the biopharmaceutical industry; uncertainties relating to our patent and proprietary rights; uncertainties relating to clinical trials, government regulation and uncertainties of obtaining regulatory approval on a timely basis or at all; risks associated with product liability; and other factors discussed in our other filings with the Securities and Exchange Commission.

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EntreMed, Inc.
Consolidated Balance Sheets

                       
          September 30, 2003   December 31, 2002
         
 
          (Unaudited)        
ASSETS
               
Current assets:
               
 
Cash and cash equivalents
  $ 18,686,195     $ 24,067,045  
 
Short term investment
    2,025,662        
 
Accounts receivable
    147,991       309,292  
 
Interest receivable
    30,436       95  
 
Prepaid expenses and other
    385,355       272,425  
 
   
     
 
Total current assets
    21,275,639       24,648,857  
Furniture and equipment, net
    1,815,575       3,152,072  
Other assets
    1,457       9,283  
 
   
     
 
Total assets
  $ 23,092,671     $ 27,810,212  
 
   
     
 
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
Current liabilities:
               
 
Accounts payable
  $ 2,145,257     $ 10,065,163  
 
Accrued liabilities
    536,439       1,891,931  
 
Current portion of deferred revenue
    115,496       110,809  
 
Current portion of notes payable
    26,419       4,864,952  
 
   
     
 
Total current liabilities
    2,823,611       16,932,855  
Deferred revenue, less current portion
    309,866       286,488  
Other long term liabilities
          80,000  
Minority interest
    17,145       17,223  
Stockholders’ equity:
               
 
Convertible preferred stock, $1.00 par and $1.50 liquidation
               
   
Value:
               
     
5,000,000 shares authorized, 3,350,000 issued and outstanding at September 30, 2003 and December 31, 2002, respectively
    3,350,000       3,350,000  
 
Common stock, $.01 par value:
               
     
90,000,000 shares authorized, 32,543,140 and 24,145,700 shares issued and outstanding at September 30, 2003 and December 31 2002, respectively
    325,431       241,457  
 
Additional paid-in capital
    251,166,089       228,316,897  
 
Treasury stock, at cost: 874,999 shares held at September 30, 2003 and December 31, 2002
    (8,034,244 )     (8,034,244 )
 
Deferred stock compensation
          (61,846 )
 
Accumulated deficit
    (226,865,227 )     (213,318,618 )
 
   
     
 
Total stockholders’ equity
    19,942,049       10,493,646  
 
   
     
 
Total liabilities and stockholders’ equity
  $ 23,092,671     $ 27,810,212  
 
   
     
 

The accompanying notes are an integral part of the consolidated financial statements.

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EntreMed, Inc.
Consolidated Statements of Operations
(Unaudited)

                                   
      Three Months Ended   Nine Months Ended
     
 
      September 30,   September 30,   September 30,   September 30,
      2003   2002   2003   2002
     
 
 
 
Revenues:
                               
 
Collaborative research and development
  $ 216,536     $ 319,058     $ 634,536     $ 551,508  
 
Licensing
    23,874       23,874       71,622       71,622  
 
Grants
                300,000       34,830  
 
Royalties
                1,727       1,793  
 
Other
    18,068       2,637       50,128       54,916  
 
   
     
     
     
 
 
    258,478       345,569       1,058,013       714,669  
Costs and expenses:
                               
 
Research and development
    3,151,002       8,870,922       9,700,523       27,041,496  
 
General and administrative
    1,748,055       3,170,141       5,049,776       11,199,493  
 
   
     
     
     
 
 
    4,899,057       12,041,063       14,750,299       38,240,989  
Interest expense
          (97,760 )           (296,254 )
Investment income
    43,485       41,624       145,677       305,336  
 
   
     
     
     
 
Net Loss
    (4,597,094 )     (11,751,630 )     (13,546,609 )     (37,517,238 )
Dividends on Series A convertible preferred stock
    (251,250 )           (753,750 )      
Net loss attributable to common shareholders
  $ (4,848,344 )   $ (11,751,630 )   $ (14,300,359 )   $ (37,517,238 )
 
   
     
     
     
 
Net loss per share (basic and diluted)
  $ (0.15 )   $ (0.54 )   $ (0.51 )   $ (1.72 )
 
   
     
     
     
 
Weighted average number of shares outstanding (basic and diluted)
    31,650,627       21,922,860       28,240,013       21,874,803  
 
   
     
     
     
 

See accompanying notes.

The accompanying notes are an integral part of the consolidated financial statements.

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EntreMed, Inc.
Consolidated Statements of Cash Flows
(Unaudited)

                     
        NINE MONTH PERIOD ENDED
        SEPTEMBER 30,
       
        2003   2002
       
 
CASH FLOWS FROM OPERATING ACTIVITIES
               
Net loss
  $ (13,546,609 )   $ (37,517,238 )
Adjustments to reconcile net loss to net cash used by operating activities:
               
 
Depreciation and amortization
    1,064,523       1,125,048  
 
Recognition of non-cash stock compensation
    33,000       44,336  
 
Loss on sale of equipment
    9,679        
 
Non-cash interest expenses
          243,411  
 
Common stock repurchase liability
          1,995,007  
 
Minority interest
    (79 )     (215 )
 
Changes in operating assets and liabilities:
               
   
Accounts receivable
    107,295       (157,684 )
   
Interest receivable
    (30,341 )     50,946  
   
Prepaid expenses and other
    (105,104 )     28,397  
   
Accounts payable
    (7,451,626 )     (7,519,184 )
   
Accrued liabilities
    (1,289,984 )     (1,020,110 )
   
Contingent grant
          80,000  
   
Deferred revenue
    43,378       405,858  
 
   
     
 
Net cash used in operating activities
    (21,165,868 )     (42,241,428 )
CASH FLOWS FROM INVESTING ACTIVITIES
               
Purchases of short term financial instruments
    (2,025,662 )      
Reduction in ownership of MaxCyte’s Cash
    (418,108 )      
Purchases of furniture and equipment
    (26,525 )     (415,510 )
 
   
     
 
Net cash provided by (used in) investing activities
    (2,470,295 )     (415,510 )
CASH FLOWS FROM FINANCING ACTIVITIES
               
Net proceeds from sale of common stock
    18,320,737       4,878,777  
Proceeds from sale of warrants
          322,520  
Payment of principle on note payable
    (65,424 )     (815,952 )
Proceeds from issuance of long-term debt
          1,678,738  
 
   
     
 
Net cash provided by financing activities
    18,255,313       6,064,083  
Net increase (decrease) in cash and cash equivalents
    (5,380,850 )     (36,592,855 )
Cash and cash equivalents at beginning of year
    24,067,045       41,386,300  
 
   
     
 
Cash and cash equivalents at end of year
  $ 18,686,195     $ 4,793,445  
 
   
     
 
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION
               
Interest paid
  $     $ 52,844  
 
   
     
 

The accompanying notes are an integral part of the unconsolidated financial statements.

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ENTREMED, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2003 (unaudited)

1.     BASIS OF PRESENTATION

     Our accompanying 2003 unaudited consolidated financial information includes the accounts of our 85% owned subsidiary, Cytokine Sciences, Inc. versus the 2002 information which reflects both Cytokine and our previously consolidated subsidiary MaxCyte, Inc. MaxCyte was formed in July 1998 as a wholly owned subsidiary and on April 1, 2000 was capitalized with $40,000 in cash including $1,000 from a MaxCyte officer. All intercompany balances and transactions have been eliminated in consolidation.

     The accompanying unaudited consolidated financial statements have been prepared in accordance with 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 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 nine-month period ended September 30, 2003 are not necessarily indicative of the results that may be expected for the year ending December 31, 2003. 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, 2002.

2.     Recent Accounting Pronouncement

     In January 2003, the Financial Accounting Standards Board issued Interpretation No. 46, Consolidation of Variable Interest Entities (“FIN 46”). FIN 46 clarifies the application of Accounting Research Bulletin No. 51, Consolidated Financial Statements, to certain entities in which equity investors do not have the characteristics of a controlling financial interest or do not have sufficient equity at risk for the entity to finance its activities without additional subordinated financial support from other parties. FIN 46 applies immediately to variable interest entities created after January 31, 2003. At the October 8, 2003, FASB meeting, the Board agreed to defer the effective date of FIN 46 for variable interests held by public companies in all entities that were acquired prior to February 1, 2003. The deferral will require that public companies adopt the provisions of the Interpretation at the end of periods ending after December 15, 2003 (that is, December 31, 2003 for a calendar year end company). We do not believe the effects of adopting FIN 46 will be material.

3.     Change in Basis of MaxCyte

The Board of Directors of both EntreMed and MaxCyte adopted a plan to recapitalize MaxCyte. As a result of the recapitalization, the Company no longer controls and no longer consolidates MaxCyte effective the first quarter of 2003; EntreMed now owns 45% of MaxCyte. The investment in MaxCyte is accounted for using the equity method. The reduction of EntreMed’s ownership in MaxCyte resulted in a change in EntreMed’s basis in MaxCyte. The change from fully

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consolidating MaxCyte to reflecting the investment in MaxCyte on the equity method resulted in a $4.6 million credit to additional paid-in capital.

4.     Short-term investments

     Short-term investments consist of corporate debt securities, all of which mature within one year. We classify these investments as available for sale. Such securities are stated at market value. The unrealized gains and losses are nominal as of September 30, 2003. 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. The cost of securities sold is calculated using the specific identification method. As of September 30, 2003, the cost of the investment was $2,025,662. Realized gains have been insignificant.

5.     Stock-Based Compensation

     In accordance with Statement of Financial Accounting Standards (“SFAS”) No. 148, Accounting for Stock-Based Compensation – Transition and Disclosure (SFAS 148), the effect on net loss and net loss per share if the Company had applied the fair value recognition provisions of SFAS No. 123, Accounting for Stock-Based Compensation (“SFAS No. 123”) to stock-based employee compensation is as follows:

                                 
    Three months ended September 30,   Nine months ended September 30,
   
 
    2003   2002   2003   2002
   
 
 
 
Net income (loss), as reported
  $ (4,597,094 )   $ (11,751,630 )   $ (13,546,609 )   $ (37,517,238 )
Deduct: Total stock-based employee compensation expense determined under fair value based method for all awards, net of related tax effects
    (2,392,117 )     (3,522,215 )     (7,176,352 )     (10,566,645 )
 
   
     
     
     
 
Pro forma net (loss)
    (6,989,211 )     (15,273,845 )     (20,722,961 )     (48,083,883 )
Dividend on Series A convertible preferred stock
    (251,250 )           (753,750 )      
 
   
     
     
     
 
Pro forma net (loss) attributable to common shareholders
  $ (7,240,461 )   $ (15,273,845 )   $ (21,476,711 )   $ (48,083,883 )
Net income (loss) per share:
                               
Basic and diluted — as reported
  $ (0.15 )   $ (0.54 )   $ (0.51 )   $ (1.72 )
Basic and diluted — pro forma
  $ (0.23 )   $ (0.70 )   $ (0.76 )   $ (2.20 )

     The effect of applying SFAS No. 123 on the three and nine month periods ended September 30, 2003 and 2002 pro forma net loss and net loss per share as stated above is not necessarily representative of the effects on reported net loss for future years, due to, among other things, (1) the vesting period of the stock options and (2) the fair value of additional stock options in future years.

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6.     Shareholders’ Equity Changes

     On April 28, 2003, we completed the sale of 4.1 million shares of common stock to institutional investors for $10.25 million in gross proceeds. In connection with the sale, we issued warrants to purchase an additional 1.025 million shares at an exercise price of $3.375 per share. The shares were offered through a prospectus supplement to our effective shelf registration statement.

     On May 20, 2003, we completed the sale of 3.0 million shares of common stock to institutional investors for $9.0 million in gross proceeds. The shares and warrants were offered through a prospectus supplement to our effective shelf registration statement.

     The Company incurred offering costs of approximately $2.2 million and issued warrants to purchase 71,000 shares of common stock to the placement agent.

7.     Subsequent event

     On November 3, 2003, we completed the sale of 5.25 million shares of common stock to institutional investors for approximately $22.3 million in gross proceeds. In connection with the sale, we issued warrants to purchase an additional 787,500 shares at an exercise price of $5.00 per share. The Security Purchase Agreement requires that the shares and warrants be registered for resale to be filed within 30 days of the transaction date.

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ITEM 2.  MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

OVERVIEW

     Since our inception in September 1991, we have devoted substantially all of our efforts and resources to sponsoring and conducting research and development on our own behalf and through collaborations. Through September 30, 2003, all of our revenues have been generated from license fees, research and development funding, royalty payments, the sale of royalty rights, the sale of our interest in a licensing agreement and certain research grants. We have not generated any revenue from direct product sales. We anticipate our primary revenue sources for the next few years to include research grants and collaboration payments under current or future arrangements. The timing and amounts of such revenues, if any, will likely fluctuate and depend upon the achievement of specified research and development milestones. Results of operations for any period may be unrelated to the results of operations for any other period.

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 financial statements and accompanying notes. Actual results could differ materially from those estimates. The items in our financial statements requiring significant estimates and judgments are as follows:

    Grant Revenue — The Company has received government grants for the development of potential malaria vaccines. We have also received a government grant to support financially our Phase II Endostatin clinical trial in patients with neuroendocrine tumors. Grants are funded in specific amounts based on funding requests submitted to the grantor. Grant revenues are recognized and realized at the time that research and development activities are performed.
 
    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.
 
    We have stock option plans under which options to purchase shares of our common stock may be granted to employees, consultants and directors at a price no less than the fair market value on the date of grant. We account for our stock-based compensation in accordance with the provisions of APB No. 25, Accounting for Stock Issued to Employees (“APB No. 25”). Under APB No. 25, compensation expense is based on the difference, if any, on the date of the grant between the fair value of the Company’s stock and the exercise price of the option and is recognized ratably over the vesting period of the option. But, because our options must be granted at fair market value, we recognize no compensation expense in accordance with APB No. 25. If we were to adopt SFAS No. 123, Accounting for Stock-Based Compensation (“SFAS No. 123”), we would recognize compensation expense based upon the fair value at the grant date for awards under the plans using the fair value method. We account for equity instruments issued to nonemployees in accordance with SFAS No. 123

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      and EITF 96-18, Accounting for Equity Instruments that are issued to other than employees for acquiring, or in conjunction with selling goods or services.

RESULTS OF OPERATIONS

For the Three and Nine Months Ended September 30, 2002 and September 30, 2003.

     Revenues. Revenues decreased in the three month period ending September 30, 2003 to approximately $258,000 from $346,000 in the comparable 2002 period. The decrease results from reduced collaborative research and development revenues of $217,000 in the third quarter 2003 versus collaborative research and development revenues of $319,000 in the comparable 2002 period. We have completed our contractual obligations resulting from our NIH subcontract, and the revenues reflected in this reporting period represent the final contract revenues. For the nine month period ending September 30, 2003, revenues increased 48% to approximately $1,058,000 from $715,000 for the 2002 nine month period. The increase results primarily from a grant received to support our Endostatin Phase II clinical trial in patients with neuroendocrine tumors and contract revenues resulting from performance as a subcontractor under an NIH sponsored Malaria Vaccine program.

     Research and Development Expenses. From inception through September 30, 2003 we have incurred research and development expenses of approximately $224,252,000. Included in this amount are the expenses related to our three clinical product candidates, Panzem®, Endostatin and Angiostatin. At September 30, 2003 the accumulated direct project expenses for each of these development projects are $21,548,000, $70,974,000 and $35,254,000 respectively. Direct project expenses for Panzem® of $3,734,000, Endostatin of $782,000 and Angiostatin of $578,000 are reflected in our 2003 R&D expenses for the nine month period ending September 30, 2003 of $9,701,000. Research and Development expenses for the comparable 2002 period were $27,041,000. The decrease reflects the refocus and elimination of some research and development programs and the associated shift in emphasis from the protein product candidates towards our small molecule programs including Panzem®. Direct project costs for Panzem®, Endostatin and Angiostatin were $2,772,000, $8,011,000 and $4,297,000 respectively for the nine month period ending September 30, 2002. In addition to the accumulated expenses attributable to our three clinical product candidates, we had sponsored several research programs at Children’s Hospital, Boston in an aggregate of $18,050,000 and we had recorded approximately $5,931,000 in research and development costs incurred by our previously consolidated subsidiary MaxCyte. Reflected in our research and development expenses are sponsored research payments to Children’s Hospital of $1,000,000 in the period ended September 30, 2002. We have not made any sponsored research payments to Children’s Hospital in the nine month period ending September 30, 2003. However, we have agreed to provide limited financial support to Children’s Hospital under a new sponsored research agreement focused on Panzem® and certain analog structures. MaxCyte’s research and development costs for the nine month period ending September 30, 2002 were $1,581,000. The balance of our accumulated research and development expenses are attributable to discovery research and preclinical development of additional product candidates and costs associated with the management of research and development operations and facilities.

     The amounts of 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 September 30, 2003, three of our proprietary product candidates, Panzem®, Endostatin and Angiostatin, were in the Phase II stage of clinical trials. Completion of clinical trials may take

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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.

     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 believe our future capital requirements and our future financial success are 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.

     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.

     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,

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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 pre-clinical testing and clinical trials of our product candidates, including the costs of manufacturing the product candidates, patent costs and facilities expenses. Research and development expenses for the three month periods ending September 30 decreased to $3,151,000 in 2003 from $8,871,000 for the comparable period in 2002. Research and development expenses for the nine month periods ending September 30 decreased to $9,701,000 in 2003 from the 2002 amount of $27,041,000. The decrease in overall research and development costs reflects the shift in emphasis from the protein product candidates towards our small molecule programs including Panzem®. Components of the decrease are broad based including the elimination of some programs and are associated with the following:

    Personnel Costs —Personnel costs decreased to $654,000 for the three month period ended September 30, 2003 from $2,466,000 in 2002. For the nine month period ended September 30, 2003 personnel costs decreased to $2,199,000 from $6,506,000 for the 2002 nine month period. These decreases reflect the approximately 60% reduction in staffing levels in 2003 from 2002. The decrease results from the refocus and elimination of some research and development programs and the associated staff reductions.
 
    Collaborative Research Agreements— We made payments to our collaborators of $153,000 during the first nine months of 2003. This amount represents a significant decrease from the 2002 amount of $3,272,000 and reflects the shift in focus to in-house efforts while reassessing our collaborative strategy. Sponsored research payments to academic collaborators include payments to Children’s Hospital, Boston of $1,000,000 in 2002. We have not made any payments to Children’s Hospital in 2003.
 
    Clinical Trial Costs—Clinical costs decreased to $278,000 in the three months ending September 30, 2003 from $698,000 in the period ending September 30, 2002. Clinical costs for the nine month period ending September 30, 2003 decreased to $1,017,000 from $2,205,000 for the comparable 2002 period. The decreases reflect less clinical activity as a result of our decision to focus on small molecule candidates led by Panzem®, while we maintain the open trials for Endostatin and Angiostatin. Costs of such trials include the clinical investigator site fees, monitoring costs and data management costs. Contracted regulatory support costs decreased in 2003 to $62,000 from $687,000 in 2002. In addition, we contribute clinical trial product material under our CRADA with the NCI who is conducting trials collaboratively with EntreMed on Panzem®.

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    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, storage, encapsulation and fill finish services and product release costs. Contract manufacturing costs for the three months ending September 30 decreased to $187,000 in 2003 from $3,297,000 in 2002. For the nine month period ending September 30, 2003 manufacturing costs decreased to $1,453,000 from $6,506,000 for the comparable 2002 period. The decrease reflects the lack of protein manufacturing in 2003 and the attendant cost savings when compared to the Company’s decision to stockpile clinical protein material in 2001 and 2002. The majority of the 2003 costs reflect the purchase of bulk Panzem® under existing commitments to support ongoing and future clinical trials and our current reformulation efforts. Other 2003 costs result primarily from Panzem® encapsulation and bulk protein storage costs. The nature and timing of our manufacturing efforts will likely result in fluctuations in manufacturing costs in future reporting periods.

     General and administrative expenses for the three month period ending September 30, decreased from $3,170,000 in 2002 to $1,748,000 in 2003. For the nine month period 2003 expenses decreased to $5,049,000 from $11,199,000 in the comparable 2002 period. The 2003 period decrease reflects our reduced head count and significantly lower legal expenses as a result of the settlement of the Abbott and BMT litigations in 2002. In the 2002 nine month period we also recorded costs of $1,995,000 associated with our Bristol Myers-Squibb stock repurchase obligation.

     Interest expense. In December 2002 we made the final payment on a promissory note secured by the majority of our equipment, and therefore, we did not record any interest expense during the three and nine month periods ending September 30, 2003. For the three and nine month periods ending September 30, 2002 interest expense totaled approximately $98,000 and $296,000, respectively. The majority of these amounts reflect the accrual of interest relating to MaxCyte’s issuance of convertible promissory notes in 2001 and 2002.

     Investment income. Investment income decreased by 52% in 2003 to $145,000 from $305,000 as a result of continued low investment yields versus the comparable period in 2002.

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 2003 and the foreseeable future before we commercialize any products. In addition, under the terms of certain licensing agreements, we must be diligent in bringing potential products to market and may be required to make future milestone payments of up to $2,685,000. If we fail to comply with the milestones or fail to make any required milestone payment, we could face the termination of the relevant license agreement.

     At September 30, 2003, we had cash and short-term investments of approximately $20,712,000 with working capital of approximately $18,551,000. In addition, we received gross proceeds of approximately $22.3 million from the sale of common stock and warrants on November 3, 2003. Based on our current operating plans, expenditures on development activities are expected to be approximately $18,000,000, net of operating revenues, in 2003, including restructuring charges of approximately $1,000,000 relating to other organizational changes as we complete our transition to small molecule programs.

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     To accomplish our business plans, we will be required to continue to conduct substantial development activities for all of our proposed products. Based on our assessment of our current capital resources and the actions discussed below, and in the absence of additional financing, we believe that we will have adequate resources to fund operations well into 2005. Our estimate may change, however, based on our decisions with respect to future clinical trials related to Panzem®, developments in our business including the acquisition of additional intellectual property and other investments in new or complimentary technology and our success in executing our current business plan.

     We intend to continue to pursue strategic relationships to 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 likely will experience substantial dilution, or the equity securities may have rights, preferences or privileges senior to those of the holders of our common stock. If we raise funds through the issuance of debt securities, those securities would have rights, preferences and privileges senior to those of our common stock.

     The table below sets forth our contractual obligations at September 30, 2003.

                                         

CONTRACTUAL OBLIGATIONS                   PAYMENTS DUE BY PERIOD        

    Total   Next twelve   1-3   4 - 5   After 5
            months   years   years   years
Debt
  $ 26,000       26,000                          
Operating Leases
    5,267,000       943,000       1,892,000       1,984,000       448,000  
Clinical Trial Contracts
    724,000       724,000                          
Collaborative Research Contracts
    650,000       350,000       300,000                  
Outside Service Contracts
    200,000       200,000                          
Contract Manufacturing
    1,490,000       1,490,000                          
Total Contractual Obligations
  $ 8,357,000       3,733,000       2,192,000       1,984,000       448,000  

     The $1.49 million Contract Manufacturing obligation set forth above reflects a manufacturing agreement entered into in 2002. We expect delivery of the materials for which the obligation is owed during the 4th quarter. We have no other outstanding purchase obligations.

INFLATION AND INTEREST RATE CHANGES

     Management does not believe that our working capital needs are sensitive to inflation and changes in interest rates.

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

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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 the total fair market value of our portfolio as of September 30, 2003.

ITEM 4.  DISCLOSURE CONTROLS AND PROCEDURES

     Under the supervision and with the participation of the Company’s President and Chief Operating Officer, and Chief Financial Officer (its principal executive officer and principal financial officer), management has evaluated the effectiveness of the design and operation of the Company’s disclosure controls and procedures. Based on that evaluation, the President and Chief Operating Officer, and Chief Financial Officer, and Corporate Secretary have concluded that these disclosure controls and procedures are effective as of September 30, 2003. There were no changes in our internal control over financial reporting during the quarter ended September 30, 2003 that have materially affected, or are reasonably likely to materially affect, the internal control over financial reporting.

PART II. OTHER INFORMATION

Item 1.  LEGAL PROCEEDINGS

     This information as set forth in Note 6 of “Notes to Consolidated Financial Statements” appearing in Item 1 of Part I of this report is incorporated herein by reference.

     In addition, EntreMed is 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 2.  CHANGES IN SECURITIES AND USE OF PROCEEDS

     Recent Sales of Unregistered Securities

     In November 2003, we sold a total of approximately 5.25 million shares at $4.25 per share. In addition, we issued five-year warrants covering an additional 787,500 shares of our common stock with an exercise price of $5.00 per share. This transaction resulted in gross proceeds of approximately $22.3 million.

     The securities were sold pursuant to Section 4(2) of the Securities Exchange Act of 1934 as a transaction not involving a public offering.

Item 3.  DEFAULTS UPON SENIOR SECURITIES

     Not applicable.

Item 4.  SUBMISSION OF MATTERS TO VOTE OF SECURITY HOLDERS

     None

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Item 5.  OTHER INFORMATION

     Not applicable.

Item 6.  EXHIBITS AND REPORTS ON FORM 8-K

  (a)   Exhibits
     
31.1   Rule 13a-14(a) Certification of President and Chief Operating Officer
31.2   Rule 13a-14(a) Certification of Chief Financial Officer
32.1   Section 1350 Certification of Equivalent of Chief Executive Officer
32.2   Section 1350 Certification of Chief Financial Officer

  (b)   Reports on Form 8-K
 
      None

Through its website at www.entremed.com, the Company makes available, free of charge, its annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, and all amendments thereto, as soon as reasonably practicable after such reports are filed with or furnished to the Securities and Exchange Commission.

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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: November 10, 2003
 
 
   
 
 
  /s/ Neil J. Campbell

Neil J. Campbell
President and Chief Operating Officer
 
 
 
Date: November 10, 2003
 
 
   
 
 
  /s/ Dane R. Saglio

Dane R. Saglio
Chief Financial Officer

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