10-Q 1 d10q.htm FORM 10-Q Form 10-Q
Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


FORM 10-Q

 


 

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

For the quarterly period ended June 30, 2007

OR

 

¨ 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 000-23223

 


CURAGEN CORPORATION

(Exact name of registrant as specified in its charter)

 


 

Delaware   06-1331400

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

322 East Main Street, Branford, Connecticut 06405

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (203) 481-1104

 


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 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. (Check one):

Large accelerated filer  ¨    Accelerated filer  x    Non-accelerated filer  ¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act.).    Yes  ¨    No  x

The number of shares outstanding of the registrant’s common stock as of August 1, 2007 was 57,952,824.

 


 


Table of Contents

CURAGEN CORPORATION AND SUBSIDIARY

FORM 10-Q

INDEX

 

     Page

PART I. Financial Information

  
  Item 1.    Financial Statements   
     Condensed Consolidated Balance Sheets as of June 30, 2007 and December 31, 2006 (unaudited)    3
     Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2007 and 2006 (unaudited)    4
     Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2007 and 2006 (unaudited)    5
     Notes to Condensed Consolidated Financial Statements (unaudited)    6 - 12
  Item 2.    Management’s Discussion and Analysis of Financial Condition and Results of Operations    13 - 24
  Item 3.    Quantitative and Qualitative Disclosures About Market Risk    24
  Item 4.    Controls and Procedures    24
PART II. Other Information   
  Item 1A.    Risk Factors    25 - 39
  Item 2.    Unregistered Sales of Equity Securities and Use of Proceeds    40
  Item 4.    Submission of Matters to a Vote of Security Holders    40
  Item 5.    Other Information    40
  Item 6.    Exhibits    42
Signatures    43
Exhibit Index    44

 

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CURAGEN CORPORATION AND SUBSIDIARY

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except par value and share data)

(unaudited)

 

     June 30,     December 31,  
     2007     2006  
ASSETS     

Current assets:

    

Cash and cash equivalents

   $ 81,456     $ 58,486  

Short-term investments

     5,818       23,473  

Marketable securities

     53,810       82,434  
                

Cash and investments

     141,084       164,393  

Income taxes receivable

     343       543  

Accounts receivable

     582       926  

Prepaid expenses

     1,670       2,595  

Assets held for sale

     3,000       34,881  
                

Total current assets

     146,679       203,338  

Restricted cash

     14,129       —    

Property and equipment, net

     635       12,214  

Intangible and other assets, net

     9,962       11,742  
                

Total assets

   $ 171,405     $ 227,294  
                
LIABILITIES AND STOCKHOLDERS’ EQUITY     

Current liabilities:

    

Accounts payable

   $ 838     $ 321  

Accrued expenses

     3,746       3,289  

Accrued payroll and related items

     948       1,810  

Interest payable

     1,650       3,306  

Current portion of deferred revenue

     89       89  

Other current liabilities

     2,523       1,575  

Current portion of convertible subordinated debt

     —         66,228  

Liabilities held for sale

     —         30,735  
                

Total current liabilities

     9,794       107,353  
                

Long-term liabilities:

    

Convertible subordinated debt, net of current portion

     110,000       110,000  

Deferred revenue, net of current portion

     1,130       1,174  
                

Total long-term liabilities

     111,130       111,174  
                

Commitments and contingencies

    

Stockholders’ equity:

    

Common Stock; $.01 par value, issued and outstanding 57,928,085 shares at June 30, 2007 and 56,390,682 shares at December 31, 2006

     579       564  

Additional paid-in capital

     523,696       518,827  

Accumulated other comprehensive income

     1,312       2,348  

Accumulated deficit

     (475,106 )     (512,972 )
                

Total stockholders’ equity

     50,481       8,767  
                

Total liabilities and stockholders’ equity

   $ 171,405     $ 227,294  
                

See accompanying notes to condensed consolidated financial statements

 

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Table of Contents

CURAGEN CORPORATION AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share data)

(unaudited)

 

     Three Months Ended
June 30,
    Six Months Ended
June 30,
 
     2007     2006     2007     2006  

Collaboration revenue

   $ 22     $ 866     $ 44     $ 2,284  
                                

Operating expenses:

        

Research and development

     10,904       11,334       22,406       22,447  

General and administrative

     3,049       3,071       7,063       6,731  

Restructuring charges

     7,479       —         7,479       —    
                                

Total operating expenses

     21,432       14,405       36,948       29,178  
                                

Loss from operations

     (21,410 )     (13,539 )     (36,904 )     (26,894 )

Interest income

     1,046       1,870       2,199       3,710  

Interest expense

     (1,271 )     (2,337 )     (2,899 )     (4,685 )
                                

Loss from continuing operations before income tax benefit

     (21,635 )     (14,006 )     (37,604 )     (27,869 )

Income tax benefit

     50       55       110       109  
                                

Loss from continuing operations

     (21,585 )     (13,951 )     (37,494 )     (27,760 )
                                

Discontinued operations:

        

Loss from discontinued operations

     (1,853 )     (348 )     (2,991 )     (403 )

Gain on sale of subsidiary

     78,352       —         78,352       —    
                                

Income (loss) from discontinued operations

     76,499       (348 )     75,361       (403 )
                                

Net income (loss)

   $ 54,914     $ (14,299 )   $ 37,867     $ (28,163 )
                                

Basic and diluted loss per share from continuing operations

   $ (0.39 )   $ (0.25 )   $ (0.67 )   $ (0.51 )

Basic and diluted income (loss) per share from discontinued operations

     1.37       (0.01 )     1.35       (0.01 )
                                

Basic and diluted net income (loss) per share

   $ 0.98     $ (0.26 )   $ 0.68     $ (0.52 )
                                

Weighted average number of shares used in computing basic and diluted net income (loss) per share

     55,744       54,798       55,580       54,709  
                                

See accompanying notes to condensed consolidated financial statements

 

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CURAGEN CORPORATION AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

 

    

Six Months Ended

June 30,

 
     2007     2006  

Cash flows from operating activities:

    

Net income (loss)

   $ 37,867     $ (28,163 )

(Income) loss from discontinued operations

     (75,361 )     403  

Adjustments to reconcile net income (loss) to net cash used in operating activities:

    

Depreciation and amortization

     3,067       3,711  

Impairment of long lived assets held for sale

     5,950       —    

Stock-based compensation

     1,857       2,436  

Stock-based 401(k) plan employer match

     248       184  

Non-cash interest income

     242       420  

Changes in assets and liabilities:

    

Income taxes receivable

     200       290  

Accrued interest receivable

     514       (8 )

Accounts receivable

     926       41  

Prepaid expenses

     1,115       (1,121 )

Intangible and other assets, net

     110       (137 )

Accounts payable

     526       116  

Accrued expenses

     457       1,291  

Accrued payroll and related items

     (861 )     (290 )

Interest payable

     (1,656 )     —    

Deferred revenue

     (44 )     (2,451 )

Other current liabilities

     948       (343 )
                

Net cash used in operating activities

     (23,895 )     (23,621 )
                

Cash flows from investing activities:

    

Acquisitions of property and equipment

     (175 )     (144 )

Proceeds from sale of fixed assets

     28       132  

Purchases of short-term investments

     —         (14,255 )

Proceeds from sales of short-term investments

     1,401       2,600  

Proceeds from maturities of short-term investments

     15,900       3,312  

Purchases of marketable securities

     —         (10,711 )

Proceeds from sales of marketable securities

     17,465       11,346  

Proceeds from maturities of marketable securities

     11,090       40,300  

Proceeds from sale of held for sale assets

     81,441       —    

Restricted cash

     (14,129 )     —    
                

Net cash provided by investing activities

     113,021       32,580  
                

Cash flows from financing activities:

    

Proceeds from exercise of stock options

     72       346  

Repayment of convertible debt

     (66,228 )     —    
                

Net cash (used in) provided by financing activities

     (66,156 )     346  
                

Cash flows from discontinued operations:

    

Net operating cash flows used in discontinued operations

     (379 )     (8,505 )

Net investing cash flows (used in) provided by discontinued operations

     (74 )     5,552  

Net financing cash flows provided by discontinued operations

     23       311  
                

Net cash used in discontinued operations

     (430 )     (2,642 )
                

Net increase in cash and cash equivalents of subsidiary held for sale

     430       2,642  
                

Net increase in cash and cash equivalents

     22,970       9,305  

Cash and cash equivalents, beginning of period

     58,486       17,697  
                

Cash and cash equivalents, end of period

   $ 81,456     $ 27,002  
                

Supplemental cash flow information:

    

Interest paid

   $ 4,258     $ 4,252  
                

Income tax benefit payments received

   $ 407     $ 1,114  
                

Acquisition of property and equipment, unpaid at end of period

   $ —       $ 40  
                

See accompanying notes to condensed consolidated financial statements

 

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CURAGEN CORPORATION AND SUBSIDIARY

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited)

 

1. Basis of Presentation and Discontinued Operations

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements. In the opinion of our management, the accompanying unaudited condensed consolidated financial statements include all adjustments, consisting of normal recurring accruals, necessary to present fairly our consolidated financial position, results of operations and cash flows. Interim results are not necessarily indicative of the results that may be expected for the entire year. The condensed consolidated financial statements of CuraGen Corporation and subsidiary (collectively, the “Company”) include CuraGen Corporation (“CuraGen”) and its former majority-owned subsidiary, 454 Life Sciences Corporation (“454”), and accordingly, all material intercompany balances and transactions have been eliminated. CuraGen reclassified its prior financial statements to present the assets and liabilities and operating results of 454 as held for sale on the condensed consolidated Balance Sheets and as a discontinued operation on the condensed consolidated Statements of Operations as a result of the Agreement and Plan of Merger (the “Merger Agreement”) signed by 454 on March 28, 2007 with Roche Holdings, Inc., and 13 Acquisitions, Inc., an indirect wholly-owned subsidiary of Roche Holdings, Inc., each affiliates of F. Hoffman-La Roche Ltd (“Roche”) (see Notes 4 and 5). The Merger Agreement was subsequently assigned by Roche Holdings, Inc. to its affiliate Roche Diagnostics Operations, Inc. (“RDO”), which is also an affiliate of Roche. The sale of 454 to RDO pursuant to the Merger Agreement closed on May 25, 2007.

The accompanying condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2006. All dollar amounts herein are shown in thousands, except par value and per share data.

 

2. Comprehensive Income (Loss)

The accumulated balance of other comprehensive income (loss) is disclosed as a separate component of stockholders’ equity and consists of unrealized gains and losses on short-term investments and marketable securities. A summary of total comprehensive income (loss) is as follows:

 

    

Three Months Ended

June 30,

   

Six Months Ended

June 30,

 
     2007     2006     2007     2006  

Net income (loss)

   $ 54,914     ($ 14,299 )   $ 37,867     ($ 28,163 )
                                

Other comprehensive loss:

        

Unrealized (losses) gains on securities:

        

Unrealized holding (losses) gains arising during period

     (1,414 )     2,751       (1,076 )     2,886  

Reclassification adjustment for losses included in net income (loss)

     21       8       40       13  
                                

Net unrealized (losses) gains on securities

     (1,393 )     2,759       (1,036 )     2,899  
                                

Total comprehensive income (loss)

   $ 53,521     ($ 11,540 )   $ 36,831     ($ 25,264 )
                                

The Company periodically reviews its investment portfolios and its investment in TopoTarget A/S (“TopoTarget”), a publicly-traded company on the Copenhagen Stock Exchange, to determine if there is an impairment that is other than temporary, and as of the balance sheet date, June 30, 2007, has not experienced any impairments in its investments that were other than temporary.

The Company’s investment in TopoTarget is classified as an available-for-sale, long-term marketable security and is included in Intangible and other assets, net, on the June 30, 2007 balance sheet at a fair value of $7,793, which includes an unrealized gain of $2,506.

 

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3. Segment Reporting

As of December 31, 2006, the Company had two reportable segments, CuraGen and 454. As of March 31, 2007, 454 was classified as a discontinued operation as a result of the Merger Agreement. Accordingly, as of June 30, 2007, and for the three and six month periods ended June 30, 2007 and 2006, respectively, the Company operated as one segment excluding discontinued operations (see Notes 4 and 5).

 

4. 454 Life Sciences/Roche Holdings, Inc. Merger

On March 28, 2007, 454 entered into the Merger Agreement with Roche Holdings, Inc. and 13 Acquisitions, Inc., an indirect wholly-owned subsidiary of Roche Holdings, Inc. Roche Holdings, Inc. subsequently assigned the Merger Agreement to its affiliate RDO. Roche Holdings, Inc. and RDO are affiliates of Roche, a global research-based healthcare company. Under the Merger Agreement, 13 Acquisitions, Inc. was merged with and into 454 (the “Merger”), with 454 continuing after the Merger as the surviving corporation and an indirect wholly-owned subsidiary of Roche Holdings, Inc.

Under the terms of the Merger Agreement, upon the closing of the sale of 454 to RDO on May 25, 2007, the purchase price before transaction costs was $152,019, of which RDO paid $140,000 in cash and $12,019 was received from the exercise of 454 stock options following the signing of the Merger Agreement and prior to the closing of the sale. Of the $140,000 received from RDO, $25,000 was placed in escrow for a period of 15 months, or until August 25, 2008, to provide for certain post-closing adjustments based on 454’s net working capital and net debt on May 25, 2007, and to secure the indemnification rights of RDO and its affiliates. The Company believes it will receive its share of the escrow fund of $14,129, after expiration of the escrow term and has included such amount in the determination of the gain on sale in accordance with Statement of Financial Accounting Standards No. 141, “Business Combinations”. As a result, $14,129 is classified as restricted cash and is included in long-term assets on the accompanying condensed consolidated Balance Sheets, due to its long-term nature as of June 30, 2007. Following the closing, as required by the Merger Agreement, 454 prepared a closing balance sheet and calculated its net working capital and net debt as of the closing date. Based upon the closing balance sheet and net working capital and net debt calculations, RDO paid an additional $1,030 in merger consideration to 454 shareholders. In July 2007, CuraGen received $582, its portion of this additional amount, which is included in the calculation of the gain on sale of subsidiary and accounts receivable on the June 30, 2007 balance sheet.

 

5. Discontinued Operations

The sale of 454 (see Note 4) on May 25, 2007 has been accounted for in accordance with Statement of Financial Accounting Standards No. 144, “Accounting for the Impairment or Disposal of Long-Lived Assets”, and accordingly, at June 30, 2006, 454’s assets and liabilities have been classified as held for sale. In addition, 454’s operating results are reported as a discontinued operation for the three and six months ended June 30, 2006 and for the periods April 1, 2007 to May 25, 2007 and January 1, 2007 to May 25, 2007.

The following table summarizes the financial information for the discontinued operations of 454 for the three and six months ended June 30, 2006, and for the periods April 1, 2007 to May 25, 2007 and January 1, 2007 to May 25, 2007:

 

    

April 1

to

May 25,
2007

   

Three months

ended

June 30,

2006

   

January 1

to

May 25,
2007

   

Six months

ended

June 30,
2006

 

Revenue:

        

Product revenue

   $ 5,833     $ 5,352     $ 14,210     $ 9,847  

Sequencing service revenue

     1,257       2,255       3,825       4,702  

Collaboration revenue

     975       375       1,350       750  

Grant revenue

     444       864       444       1,348  

Milestone revenue

     2,173       950       3,707       1,900  
                                

Total revenue

   $ 10,682     $ 9,796     $ 23,536     $ 18,547  
                                

Operating Expenses:

        

Cost of product revenue

   $ 3,547     $ 3,314     $ 9,015     $ 5,941  

Cost of sequencing service revenue

     1,131       1,050       2,207       2,040  

Grant research expenses

     425       798       425       1,197  

Research and development expenses

     3,505       3,456       7,908       6,749  

General and administrative expenses

     4,006       1,869       7,075       3,594  
                                

Total operating expenses

   $ 12,614     $ 10,487     $ 26,700     $ 19,522  
                                

Loss from discontinued operations before minority interest, net of tax of $18, $0, $26, and $0

   $ (1,853 )   $ (596 )   $ (3,053 )   $ (743 )

Minority interest in loss of discontinued consolidated subsidiary

     —         248       62       340  

Gain on sale of subsidiary

     78,352       —         78,352       —    
                                

Income (loss) from discontinued operations

   $ 76,499     $ (348 )   $ 75,361     $ 403  
                                

 

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During the third quarter of 2006, the cumulative losses applicable to the minority interest in subsidiary exceeded the minority interest in the equity capital of 454, therefore, the majority of losses applicable to the minority interest from the third quarter of 2006 through the closing of the sale of 454 were charged to CuraGen.

The following tables set forth the components of 454’s assets and liabilities classified as held for sale on the condensed consolidated Balance Sheets at December 31, 2006 (in thousands):

 

    

December 31,

2006

Cash and cash equivalents

   $ 4,164

Short-term investments

     1,507

Marketable securities

     90

Accounts, grants and royalty receivable

     10,850

Inventory

     9,855

Property and equipment, net

     3,945

Licensing fees, net

     3,281

Other assets

     1,189
      

Assets held for sale

   $ 34,881
      
    

December 31,

2006

Accounts payable

   $ 841

Accrued expenses

     1,458

Deferred revenue

     27,539

Other liabilities

     897
      

Liabilities held for sale

   $ 30,735
      

 

6. Stock-Based Compensation

The Company adopted Statement of Financial Accounting Standards No. 123 (revised 2004), “Share-Based Payment” (“SFAS 123R”), effective January 1, 2006. SFAS 123R requires recognition of the fair value of stock-based compensation in net earnings.

During the three and six months ended June 30, 2007 and 2006, the Company recognized compensation expense in total operating expenses on the condensed consolidated statements of operations with respect to employee stock options and restricted stock grants as follows:

 

    

Three Months Ended

June 30,

  

Six Months Ended

June 30,

     2007    2006    2007    2006

Compensation expense with respect to employee stock options

   $ 386    $ 780    $ 787    $ 1,247

Compensation expense with respect to restricted stock grants

   $ 672    $ 565    $ 1,276    $ 1,301

Due to the Company’s net loss position, no tax benefit was recorded during the periods presented above.

For the three and six months ended June 30, 2007 and 2006, the adoption of SFAS 123R had the effect of increasing the loss from continuing operations and basic and diluted loss per share from continuing operations, over amounts that would have been reported using the intrinsic value method under APB 25, as follows:

 

    

Three Months Ended

June 30,

  

Six Months Ended

June 30,

     2007    2006    2007    2006

Increase in loss from continuing operations

   $ 386    $ 780    $ 787    $ 1,247

Increase in basic and diluted loss per share from continuing operations

   $ 0.01    $ 0.01    $ 0.01    $ 0.02

 

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The fair value of options granted during the three months ended June 30, 2007 and 2006 were estimated as of the grant date using the Black-Scholes option valuation model with the following assumptions:

 

     Three Months Ended
June 30,
 
     2007     2006  

Expected stock price volatility

   69 %   79 %

Risk-free interest rate

   4.79 %   4.33 %

Expected option term in years

   6.25     6.25  

Expected dividend yield

   0 %   0 %

The approximate weighted-average grant date fair values using the Black-Scholes option valuation model of all stock options granted during the three and six months ended June 30, 2007 and 2006 were as follows:

 

Three Months Ended

June 30,

  

Six Months Ended

June 30,

2007    2006    2007    2006
$1.82    $ 2.76    $ 2.34    $ 2.90

The 2007 Stock Incentive Plan (“2007 Stock Plan”) was approved by the Company’s stockholders as of May 2, 2007. The 2007 Stock Plan provides for the issuance of stock options and stock grants to employees, directors and consultants of CuraGen. A total of 3,000,000 shares of common stock were reserved for issuance under the 2007 Stock Plan. A summary of the stock option activity under the 2007 Stock Plan, as of June 30, 2007, and changes during the three months ended June 30, 2007, are as follows:

 

     

Number

of Options

  

Weighted

Average

Exercise Price

  

Weighted Average

Remaining

Contractual Life

(in years)

  

Aggregate

Intrinsic

Value

Outstanding May 2, 2007

   —           

Granted

   109,500    $ 2.73      

Exercised

   —           

Canceled or lapsed

   —           
             

Outstanding June 30, 2007

   109,500      2.73    9.84    $ 0
                   

Exercisable June 30, 2007

   107,500      2.73    9.84    $ 0
                   

A summary of the stock option activity under the 1997 Employee, Director and Consultant Stock Plan (“1997 Stock Plan”) as of June 30, 2007, and changes during the three months ended June 30, 2007, are as follows:

 

     

Number

of Options

   

Weighted

Average

Exercise Price

  

Weighted Average

Remaining

Contractual Life

(in years)

  

Aggregate

Intrinsic

Value

Outstanding April 1, 2007

   6,240,788     $ 9.31      

Granted

   —            

Exercised

   —            

Canceled or lapsed

   (251,945 )     6.66      
              

Outstanding June 30, 2007

   5,988,843       9.42    4.79    $ 0
                    

Exercisable June 30, 2007

   4,301,248       11.35    3.43    $ 0
                    

 

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The total intrinsic value of options exercised under the 1997 Stock Plan during the three months ended June, 30, 2006 was $18. There were no options exercised under the 1997 Stock Plan during the three months ended June, 30, 2007.

There was no significant activity in the 1993 Stock Option and Incentive Award Plan (“1993 Stock Plan”) during either the three months ended June 30, 2007 or 2006.

As of June 30, 2007 there was $2,349 of total unrecognized compensation expense related to unvested stock option grants under the 1993 Stock Plan, 1997 Stock Plan and 2007 Stock Plan, and this expense is expected to be recognized over a weighted-average period of 1.63 years.

A summary of all restricted stock activity under the 2007 Stock Plan as of June 30, 2007, and changes during the three months ended June 30, 2007, are as follows:

 

    

Number

of Shares

of Restricted Stock

  

Weighted

Average

Grant Date Fair Value

Outstanding May 2, 2007

   —     

Granted

   975,000    $ 1.25

Restrictions lapsed

   —     

Repurchased upon employee termination

   —     
       

Outstanding June 30, 2007

   975,000      1.25
       

On May 25, 2007, the Compensation Committee of the Company approved the issuance of an aggregate of 975,000 shares of restricted common stock to five executive officers, which will vest and become free from forfeiture on December 31, 2008, if the closing price of the common stock on the Nasdaq Global Market has equaled or exceeded $5.00 per share over a period of 20 consecutive trading days for any period ending on or before December 31, 2008. In each case, the shares of common stock described above will only vest if the executive is an employee of the Company as of December 31, 2008. Therefore, pursuant to SFAS 123R, the above restricted stock awards are deemed to contain a market condition which is reflected in the grant-date fair value of the awards, based on a valuation technique which considered all the possible outcomes of such market condition. Compensation cost is required to be recognized over the requisite service period for an award with a market condition provided that the requisite service is rendered, regardless of when, if ever, the market condition is satisfied. Accordingly, the Company shall reverse previously recognized compensation cost for the above awards only if the requisite service is not rendered.

A summary of all restricted stock activity under the 1997 Stock Plan as of June 30, 2007, and changes during the three months ended June 30, 2007, are as follows:

 

    

Number

of Shares

of Restricted Stock

   

Weighted

Average

Grant Date Fair Value

Outstanding April 1, 2007

   1,386,325     $ 4.14

Granted

   —      

Restrictions lapsed

   (300,000 )     3.43

Repurchased upon employee termination

   (7,060 )     4.62
        

Outstanding June 30, 2007

   1,079,265       4.33
        

The total intrinsic value of restricted shares vested during the six months ended June 30, 2007 and 2006 was $810 and $384, respectively.

As of June 30, 2007, there was $4,048 of total unrecognized compensation expense related to unvested restricted stock grants under the 1997 Stock Plan and 2007 Stock Plan, and this expense is expected to be recognized over a weighted-average period of 1.16 years.

As a result of the sale of 454 discussed in Note 4 above, 454’s operating results are being reported as discontinued operations for the three and six months ended June 30, 2006 and for the periods April 1, 2007 to May 25, 2007 and January 1, 2007 to May 25, 2007. During the three and six months ended June 30, 2006, 454 recognized compensation expense of $149 and $338, respectively, with respect to employee stock option awards which is included in loss from discontinued operations. During the periods April 1, 2007 to May 25, 2007 and January 1, 2007 to May 25, 2007, 454 recognized compensation expense of $392 and $2,314,

 

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respectively, with respect to employee stock option awards. During the period April 1, 2007 to May 25, 2007, 454 recorded an incremental charge of $2,177 with respect to employee stock option awards, related to the accelerated vesting of stock options in connection with the Merger.

 

7. Income (Loss) Per Share

Basic income (loss) per share is computed by dividing net income (loss) by the weighted average number of shares of common stock outstanding for the period, excluding unvested restricted stock. Diluted income (loss) per share reflects the potential dilution that could occur if options or other contracts to issue common stock were exercised or converted into common stock. Convertible subordinated debt, stock options granted under CuraGen’s stock option plans but not yet exercised and unvested restricted stock are anti-dilutive and therefore not considered for the diluted income (loss) per share calculations. Anti-dilutive potential common shares, consisting of convertible subordinated debt, outstanding stock options and unvested restricted stock were 19,582,991 and 20,046,407 as of June 30, 2007 and 2006, respectively.

 

8. Restructuring Charge

In June 2007, the Company underwent a corporate restructuring to reduce operating costs and to focus resources on the advancement of its therapeutic pipeline through clinical development, resulting in an estimated total restructuring charge of $8,352. During the second quarter of 2007, the Company recorded a restructuring charge of $7,479. This amount includes an asset impairment charge of $5,950 associated with the closure of its pilot manufacturing plant, $1,272 related to employee separation costs and $257 of other asset write-offs. The employee separation costs were recorded under Statement of Financial Accounting Standards No. 146, “Accounting for Costs Associated with Exit or Disposal Activities” (“SFAS 146”), and included amounts to be paid for severance and related benefits, the services for which will be performed within a minimum retention period.

At June 30, 2007, the pilot manufacturing plant and certain other assets were classified as held for sale on the June 30, 2007 balance sheet. These assets are expected to generate sale proceeds of approximately $3,000 during the second half of 2007.

Additional restructuring charges for severance and related benefits of approximately $708 will be recorded during the second half of 2007, as they relate to services to be performed during the third and fourth quarters of 2007 by a small number of the approximately 40 affected employees who will be completing ongoing projects through the end of 2007.

In addition, pursuant to the terms of restricted stock agreements held by various employees being terminated in connection with the restructuring, the individual’s ownership of such restricted shares shall become immediately vested if the Company terminates the individual’s employment or service by way of an “involuntary termination.” Therefore, non-cash restructuring charges of $165 will be recorded during the second half of 2007 as compensation expense with respect to the accelerated vesting of these restricted stock grants.

The cash requirements under the June 2007 restructuring plan are $1,956, none of which was paid prior to June 30, 2007. The majority of the cash requirements of $1,956 will be paid through December 2007.

 

9. Accounting for Uncertainty in Income Taxes

In July 2006, the Financial Accounting Standards Board (“FASB”) issued FASB Interpretation No. 48, “Accounting for Uncertainty in Income Taxes” (“FIN 48”). FIN 48 clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements in accordance with FASB Statement No. 109 “Accounting for Income Taxes.” This interpretation prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. It also provides guidance on derecognition, classification, interest and penalties, accounting for taxes in interim periods and disclosure requirements. The provisions of FIN 48 are to be applied to all tax positions upon initial adoption of this standard. Only tax positions that meet the more-likely-than-not recognition threshold at the effective date may be recognized or continue to be recognized upon adoption of FIN 48. Unrecognized tax benefits are tax benefits claimed in our tax returns that do not meet these recognition and measurement standards. The cumulative effect of applying the provisions of FIN 48 should be reported as an adjustment to the opening balance of retained earnings for that fiscal year. The provisions of FIN 48 are effective for fiscal years beginning after December 15, 2006. For the Company, this interpretation was effective beginning January 1, 2007.

 

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As a result of the implementation of FIN 48, the Company recorded no adjustments in its unrecognized income tax benefits. As of January 1, 2007 and June 30, 2007, the Company had unrecognized income tax benefits totaling $0.8 million and $0.9 million, respectively. If recognized, all of the unrecognized tax benefits would be recorded as a benefit to income tax expense on the condensed consolidated statements of income. The Company does not currently anticipate significant changes in the amount of unrecognized income tax benefits over the next year.

To the extent penalties and interest would be assessed on any underpayment of income tax, the Company’s policy is that such amounts would be accrued and classified as a component of income tax expense in the financial statements. To date the Company has not accrued any interest or penalties as they would be immaterial.

As a result of net operating loss carryforwards, the Company’s federal tax returns since 1992 remain open to examination with no years currently under examination by the Internal Revenue Service, and the Company’s Connecticut tax returns remain open to examination for all years since 2000 with no years currently under examination by the Department of Revenue Services.

 

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CURAGEN CORPORATION AND SUBSIDIARY

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Our management’s discussion and analysis of our financial condition and results of operations include the identification of certain trends and other statements that may predict or anticipate future business or financial results. There are important factors that could cause our actual results to differ materially from those indicated. See “Part II, Item 1A., Risk Factors.”

Overview

We are a biopharmaceutical development company dedicated to improving the lives of patients by developing novel protein, antibody and small molecule therapeutics for the treatment of cancer and for cancer supportive care. We have taken a systematic approach to identifying and validating promising therapeutic targets and our efforts are focused on developing and advancing three potential therapeutics: velafermin, belinostat (PXD101) and CR011-vcMMAE, through clinical development, and towards commercialization.

Corporate Restructuring

On June 19, 2007, we announced a corporate restructuring plan to reduce operating costs and to focus resources on the advancement of our therapeutic pipeline through clinical development. In connection with the restructuring, we closed our pilot manufacturing plant, also known as the Biopharmaceutical Sciences Process facility, or BPS, on July 27, 2007. The BPS facility is a 29,000 square foot, leased facility that was used by us for pilot scale production of proteins and antibodies. The BPS facility primarily supported early-stage pipeline development and non-GMP manufacturing efforts. We also announced a reduction in workforce of approximately 40 employees, primarily composed of preclinical and manufacturing researchers, and additional support staff from within the organization. Affected employees will be eligible for a severance package that includes severance pay, continuation of benefits and outplacement services. The restructuring actions are expected to be substantially completed by the end of 2007.

The restructuring resulted in an estimated total restructuring charge of approximately $8.4 million. During the second quarter of 2007, we recorded a restructuring charge of approximately $7.5 million, which includes an asset impairment charge of $6.0 million associated with the closure of the BPS, $0.3 million of other asset write-offs and $1.3 million related to employee separation costs. At June 30, 2007, the BPS and certain other assets were classified as held for sale on the June 30, 2007 balance sheet. These assets are expected to generate sale proceeds of approximately $3 million during the second half of 2007. The cash payments of approximately $2 million for severance and other related obligations are expected to be paid out over the remainder of 2007. Additional restructuring charges for severance and related benefits of approximately $0.7 million will be recorded during the second half of 2007, as they relate to services to be performed during the third and fourth quarters of 2007 by a small number of the affected employees who will be completing ongoing projects through the end of 2007.

Completion of 454 Acquisition

On May 25, 2007, the acquisition of 454 Life Sciences Corporation, a Delaware corporation and our majority-owned subsidiary, or 454, by Roche Diagnostics Operations, Inc., or RDO, was completed. The acquisition was accomplished through the merger of 13 Acquisitions, Inc., a Delaware corporation and a direct wholly-owned subsidiary of RDO with and into 454, or the Merger, with 454 continuing after the Merger as the surviving corporation as a direct wholly-owned subsidiary of RDO, all in accordance with an Agreement and Plan of Merger dated March 28, 2007 by and among Roche Holdings, Inc., 454 and 13 Acquisitions, or the Merger Agreement. Roche Holdings, Inc. subsequently assigned its rights and obligations under the Merger Agreement to RDO, an indirect wholly-owned subsidiary of Roche Holdings, Inc., prior to the closing of the Merger. Roche Holdings, Inc. and RDO are affiliates of F. Hoffman-La Roche Ltd.

The purchase price paid for 454 was $152.0 million in cash, of which RDO paid $140.0 million and $12.0 million of which was received from the exercise of 454 stock options following the signing of the Merger Agreement. Of the $140.0 million

 

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received from RDO, $25.0 million was placed in escrow for a period of 15 months from the date of closing, or until August 25, 2008, to secure the indemnification rights of RDO and its affiliates. Our portion of the escrow amounted to $14.1 million and is included in the net proceeds of $82.0 million received during the second quarter of 2007. This $14.1 million is classified as restricted cash and included in long-term assets on the accompanying condensed consolidated Balance Sheets as of June 30, 2007.

Following the closing, as required by the Merger Agreement, 454 prepared a closing balance sheet and calculated its net working capital and net debt as of the closing date. Based upon the closing balance sheet and net working capital and net debt calculations, RDO paid an additional $1,030 in merger consideration to 454 shareholders. In July 2007, CuraGen received $582, its portion of this additional amount, which is included in the calculation of the gain on sale of subsidiary and in accounts receivable on the June 30, 2007 balance sheet.

CuraGen Clinical Oncology Pipeline

We are currently focusing our resources on the development of the following clinical oncology therapeutics in the areas of cancer supportive care and the treatment of cancer:

Velafermin—is a protein therapeutic that we are investigating for the prevention of oral mucositis, or OM, a debilitating side effect experienced by many cancer patients receiving treatment with chemotherapy, radiotherapy, or a combination thereof. To confirm the activity of a single intravenous infusion of 30 mcg/kg of velafermin, we are conducting a second Phase II trial, which completed enrollment of 390 patients in July 2007. This study is evaluating the efficacy of 30 mcg/kg velafermin compared to placebo for the prevention of OM, and also evaluating the activity of a single dose of 10 mcg/kg velafermin or 60 mcg/kg velafermin compared to placebo. Top-line 30-day efficacy and safety results from this trial are expected to be released during October 2007. One-year safety data from this trial is anticipated to be available during the fourth quarter of 2008.

Belinostat (PXD101)—is a small molecule therapeutic that inhibits the activity of the enzyme histone deacetylase, or HDAC, and is being evaluated for the treatment of solid and hematologic cancers either alone or in combination with other active chemotherapeutic drugs and newer targeted agents. We are conducting clinical trials evaluating intravenous and oral belinostat (PXD101) for:

 

Indication

  

Phase

  

Regimen

  

Initiation of Patient
Enrollment

  

Milestone

Solid tumors    Ib    Combination with
5-fluorouracil (“5-FU”)
   September 2005    Results presented June 2007
Solid tumors    Ib    Combination with
paclitaxel and/or
carboplatin
   September 2005    Results presented June 2007
T-cell lymphoma    II    Monotherapy    January 2006    Updated preliminary results anticipated Q4 2007
Advanced solid tumors    I    Oral belinostat monotherapy    August 2006    Preliminary results expected Q4 2007
Ovarian cancer    II    Combination with
paclitaxel and/or
carboplatin
   November 2006    Updated preliminary results anticipated Q4 2007
Bladder cancer    II    Combination with
paclitaxel and/or
carboplatin
   June 2007    Preliminary results anticipated in the second half of 2008

On June 12, 2007, we presented an update on the clinical development program for belinostat and reported preliminary clinical trial results suggesting clinical activity of belinostat against cutaneous T-cell lymphoma, or CTCL, peripheral T-cell lymphoma, or PTCL, and ovarian cancers.

We reported interim results from our Phase II trial evaluating belinostat as a single agent on 14 patients with CTCL and 11 evaluable patients with PTCL. In the CTCL arm, patients had received a median of six prior lines of therapy. Four of 14 patients achieved an objective response after receiving belinostat for an objective response rate of 29%, including one complete response and three partial responses. Time to response ranged from 8 to 57 days. As demonstrated by a decrease in severity weighted assessment tool, or SWAT, scores, 77% of evaluable patients showed an improvement in skin burden of CTCL. As previously announced in December 2006, the CTCL arm was expanded to enroll up to 34 patients to further refine the magnitude of the objective response rate.

 

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In the PTCL arm, two of 11 evaluable patients achieved an objective response including one complete response and one partial response, with best responses not yet determined in 2 patients whose treatment is ongoing. We announced that based on a recent review of this data internally and with the study investigators, the degree of activity observed in the first phase of this study meets the predefined criteria to expand enrollment of the PTCL arm to a total of 34 patients.

We reported Phase Ib dose-escalation (belinostat plus standard doses of carboplatin and paclitaxel) results on 23 patients with advanced solid tumors that were presented at the 2007 American Society of Clinical Oncology, or ASCO, meeting in June 2007. The results suggest that the combination of intravenous belinostat plus standard doses of carboplatin and paclitaxel are generally well tolerated. Two partial responses (1 pancreatic and 1 rectal cancer) were reported and one patient with mixed mullerian cancer of ovarian origin achieved an 81% reduction in CA-125 levels. In addition, 11 patients achieved stable disease, or SD, including one patient with bladder cancer (SD for 20 cycles), and one patient with carcinoma of unknown primary (SD for 17 cycles and ongoing).

The Phase II portion of our trial evaluating intravenous belinostat in combination with carboplatin and paclitaxel for ovarian cancer was initiated, with 16 patients having been treated and 13 patients continuing on study and undergoing assessment to determine their response to treatment as of June 2007. We reported updated results from our Phase II trial evaluating belinostat in combination with carboplatin and paclitaxel for the treatment of ovarian cancer. To date, three partial responses (two confirmed, one unconfirmed) were achieved in 23 heavily pretreated patients with recurrent ovarian cancer enrolled, of which 14 patients remain on study with best response yet to be determined. The preliminary response rate triggered expansion of enrollment to a total of 32 patients in this trial.

Furthermore, this Phase II study has been broadened to include an additional arm that will enroll up to 15 patients with transitional cell cancer of the bladder in order to evaluate the activity of belinostat in combination with carboplatin and paclitaxel in this patient population. Interim results are anticipated during the second half of 2008.

Phase Ib dose-escalation results on 25 patients with advanced solid tumors were presented at ASCO in June 2007 and indicate that the combination of intravenous belinostat plus 5-FU is generally well tolerated. Two dose limiting toxicities, including one Grade 3 stomatitis and one Grade 3 angina were reported in the highest dose group evaluating 1000 mg/m 2 /day belinostat plus 1000 mg/2m2/day 5-FU. All patients received extensive pre- and post-treatment ECG monitoring with no Grade 3 QTc prolongation noted.

Of the 23 evaluable patients, a total of seven patients achieved SD (range 2 – 8 cycles), with two patients on treatment as of June 2007, and no objective responses noted. No consistent effect was seen on the expression of thymidylate synthase (TS) in peripheral blood mononuclear cells from this population. As of June 12, 2007, enrollment of patients is continuing into the 1000 mg/m2/day belinostat and 500 mg/m2/day 5-FU dose cohort. Six additional patients are planned to be enrolled at this dose to determine whether there is any effect on the expression of TS in tissue samples, although further development of this indication is not planned at this time.

On August 6, 2007, we announced that we will not enroll additional patients into a Phase II open-label clinical trial evaluating intravenous belinostat in combination with Velcade® (bortezomib) for Injection in patients with advanced, refractory multiple myeloma, or MM. Two out of four patients enrolled in the study developed acute renal insufficiency, or ARI, in the first cycle of treatment with the combination. Three similar events of ARI were previously reported from studies evaluating belinostat monotherapy in patients with MM. To date, no ARI has been observed in any other indication for which intravenous or oral belinostat is being evaluated.

On August 6, 2007, we also announced we are preparing to initiate a Phase I/II clinical trial evaluating belinostat in combination with the idarubicin for the treatment of acute myelogenous leukemia, or AML. The study will be conducted at multiple sites in the European Union. Up to 70 patients will be enrolled and receive intravenous treatment in one of two regimens. Patients will either receive intravenous belinostat administered once daily for five days in combination with idarubicin or a continuous infusion of belinostat with or without idarubicin. Enrollment into the treatment arms will occur in parallel to define the maximum tolerated dose, or MTD, for each treatment regimen.

In addition to the clinical trials being sponsored by us, the National Cancer Institute, or NCI, is also conducting clinical trials evaluating intravenous belinostat (PXD101), both alone and in combination, for other cancer indications under a Clinical Trials Agreement we signed with the NCI in August 2005:

 

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Indication

  

Phase

  

Regimen

  

Initiation of Patient

Enrollment

Advanced solid tumors or lymphomas    Ib    Combination with Velcade ®    March 2006
Acute Myelogenous Leukemia    II    Monotherapy    June 2006
Advanced solid tumors    Ib    Combination with
cis-retinoic acid
   June 2006
Mesothelioma    II    Monotherapy    June 2006
Hepatocellular carcinoma    I/II    Monotherapy    July 2006
Advanced hematologic malignancies    I    Combination with azacitidine    August 2006
B-cell lymphomas    II    Monotherapy    August 2006
Ovarian    II    Monotherapy    November 2006
Myelodysplastic Syndrome    II    Monotherapy    November 2006

CR011-vcMMAE—is a fully-human monoclonal antibody resulting from our collaboration with Amgen Fremont and utilizes antibody-drug conjugate, or ADC, technology licensed from Seattle Genetics to attach MMAE to yield CR011-vcMMAE. In June 2006, we announced that the investigational new drug application for CR011-vcMMAE was cleared by the FDA and dosing of patients in a Phase I/II clinical trial had begun. The open-label, multi-center, dose escalation study will evaluate the safety, tolerability and pharmacokinetics of CR011-vcMMAE for patients with Stage III or Stage IV melanoma who have failed no more than one prior line of cytotoxic therapy. The first part of the trial is evaluating cohorts of patients receiving increasing doses of CR011-vcMMAE to determine the maximum tolerated dose, or MTD. After determination of the MTD, up to approximately 30 additional patients will be enrolled and treated at the MTD to further define safety and efficacy in this Phase I trial. Preliminary results from this trial are expected to be reported during the fourth quarter of 2007.

Summary

We seek to generate value for our shareholders by developing novel therapeutics for the treatment of cancer and cancer supportive care. We seek to become profitable by commercializing a subset of therapeutics stemming from our development pipeline, and establishing partnerships with pharmaceutical and biotechnology companies for the development and commercialization of other therapeutics from our development pipeline. Our failure to successfully develop pharmaceutical products that we can commercialize would materially adversely affect our business, financial condition and results of operations. Royalties or other revenue generated from commercial sales of therapeutic products developed through the application of our technologies and expertise are not expected for several years, if at all.

We expect to continue incurring substantial research and development expenses relating to clinical trials required for the development of therapeutic protein, antibody and small molecule product candidates, and external programs that we identify as being promising and synergistic with our products and expertise. Conducting clinical trials is a lengthy, time-consuming and expensive process. As a result, we expect to incur continued losses over the next several years.

While we will continue to explore alternative sources for financing our business activities, including the possibility of public securities offerings and/or private strategic-driven common stock offerings, we cannot be certain that in the future these sources will be available when needed or that our actual cash requirements will not be greater than anticipated. In appropriate strategic situations, we may seek financial assistance from other sources, including the sale of certain assets, contributions by others to joint ventures, and other collaborative or licensing arrangements for the development and testing of products under development. However, should we be unable to obtain future financing either through the methods described above or through other means, we may be unable to meet the critical objective of our long-term business plan, which is to successfully develop and market pharmaceutical products, and may be unable to continue operations. This result could cause our shareholders to lose all or a substantial portion of their investment.

 

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Critical Accounting Policies and Use of Estimates

Our discussion and analysis of our financial condition and results of operations are based upon our condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amount of assets and liabilities, revenues and expenses. On an on-going basis, we evaluate our estimates, including those related to revenue recognition and accrued expenses. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. Our significant accounting policies are more fully described in Note 1 to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2006.

 

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Results of Operations

The following table sets forth a comparison of the components of our net income (loss) for the three months ended June 30, 2007 and 2006 (in millions):

 

     Three months ended June 30,  
     2007    2006     $ Change     % Change  

Collaboration revenue

   $ —      $ 0.9     $ (0.9 )   (100 )%

Research and development expenses

     10.9      11.4       (0.5 )   (4 )%

General and administrative expenses

     3.1      3.1       —       0 %

Restructuring charge

     7.5      —         7.5     100 %

Interest income

     1.1      1.9       (0.8 )   (42 )%

Interest expense

     1.3      2.3       (1.0 )   (43 )%

Income tax benefit

     0.1      0.1       —       0 %

Loss from discontinued operations

     1.9      0.4       1.5     375 %

Gain on sale of subsidiary

     78.4      —         78.4     100 %
                   

Net income (loss)

   $ 54.9    $ (14.3 )    
                   

The following table sets forth a comparison of the components of our net income (loss) for the six months ended June 30, 2007 and 2006 (in millions):

  

     Six months ended June 30,  
     2007    2006     $ Change     % Change  

Collaboration revenue

   $ —      $ 2.3     $ (2.3 )   (100 )%

Research and development expenses

     22.4      22.5       (0.1 )   0 %

General and administrative expenses

     7.1      6.8       0.3     4 %

Restructuring charge

     7.5      —         7.5     100 %

Interest income

     2.2      3.7       (1.5 )   (41 )%

Interest expense

     2.9      4.6       (1.7 )   (37 )%

Income tax benefit

     0.1      0.2       (0.1 )   (50 )%

Loss from discontinued operations

     3.0      0.5       2.5     500 %

Gain on sale of subsidiary

     78.4      —         78.4     100 %
                   

Net income (loss)

   $ 37.8    $ (28.2 )    
                   

Collaboration revenue. The decrease in our collaboration revenue for the three and six month periods ended June 30, 2007, as compared to the three and six month periods ended June 30, 2006 was due to the completion of work under the Bayer AG Pharmacogenomics Agreement during the second quarter of 2006. We do not expect to recognize additional collaboration revenue during 2007, with the exception of immaterial amounts of collaboration revenue related to the amortization of the $1.3 million received during 2006 from the LEO Pharma/TopoTarget licensing agreement.

Research and development expenses. Research and development expenses consist primarily of: contractual and manufacturing costs; salary and benefits; perpetual license fees; supplies and reagents; depreciation and amortization; and allocated facility costs. Historically, our research and development efforts have been concentrated on three major project areas: clinical trials; preclinical drug candidates; and collaborations. However, upon completion of our work on the Bayer AG Pharmacogenomics Agreement during the second quarter of 2006, and subsequent to our decision in the first quarter of 2007 to focus our resources during 2007 exclusively on generating clinical trial results from our three lead oncology drug development programs, our research and development efforts are now being concentrated on clinical trials. We budget and monitor our research and development costs by expense category, rather than by specific project, because these costs often benefit multiple projects.

Below is a summary that reconciles our total research and development expenses for the three and six month periods ended June 30, 2007 and 2006 (in millions):

 

     Three months ended June 30,  
     2007    2006    $ Change     % Change  

Contractual and manufacturing costs

   $ 5.7    $ 4.5    $ 1.2     27 %

Salary and benefits

     2.5      2.6      (0.1 )   (4 )%

Supplies and reagents

     0.4      0.4      —       0 %

Perpetual license fees and milestone payments

     —        1.3      (1.3 )   (100 )%

Depreciation and amortization

     0.5      0.7      (0.2 )   (29 )%

Allocated facility costs

     1.8      1.9      (0.1 )   (5 )%
                  

Total research and development expenses

   $ 10.9    $ 11.4     
                  

 

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     Six months ended June 30,  
     2007    2006    $ Change     % Change  

Contractual and manufacturing costs

   $ 11.7    $ 9.3    $ 2.4     26 %

Salary and benefits

     5.4      5.5      (0.1 )   (2 )%

Supplies and reagents

     0.6      1.0      (0.4 )   (40 )%

Perpetual license fees and milestone payments

     0.1      1.3      (1.2 )   (92 )%

Depreciation and amortization

     1.1      1.5      (0.4 )   (27 )%

Allocated facility costs

     3.5      3.9      (0.4 )   (10 )%
                  

Total research and development expenses

   $ 22.4    $ 22.5     
                  

The decrease in our research and development expenses for the three months ended June 30, 2007, as compared to the three months ended June 30, 2006, was primarily due to a decrease in license fees and milestone payments (related to our collaboration with Seattle Genetics) offset by an increase in contractual and manufacturing costs. Research and development expenses for the six months ended June 30, 2007, as compared to the six months ended June 30, 2006 remained relatively constant, due to the same trends and offsets mentioned above. We anticipate our research and development expenses for the remainder of 2007 to decrease due to the second quarter 2007 restructuring, which included the closing of our BPS.

As soon as we advance a potential clinical candidate into clinical trials, we begin to track the direct research and development expenses associated with that potential clinical candidate. The following table shows the cumulative direct research and development expenses as of June 30, 2007, as well as the current direct research and development expenses for the three and six month periods ended June 30, 2007 and 2006 which were incurred on or after we started conducting a Phase I clinical trial for a clinical candidate (in millions):

 

Therapeutic Area and Clinical Candidate

   Class    Cumulative as
of June 30,
2007 (since
commencement
of Phase I)
   Indication    Trial Status

Cancer Supportive Care

           

Velafermin

   Protein    $ 45.0    Oral Mucositis    Phase II

Oncology

           

PXD101

   Small Molecule    $ 37.0    Various Cancers    Phase II

CR011-vcMMAE

   Antibody-Drug
Conjugate
   $ 5.8    Metastatic Melanoma    Phase I

Kidney Inflammation

           

CR002

   Antibody    $ 1.8    Kidney Inflammation    Phase I

 

     Three Months Ended    Six Months Ended

Therapeutic Area and Clinical Candidate

   June 30,
2007
   June 30,
2006
   June 30,
2007
   June 30,
2006

Cancer Supportive Care

           

Velafermin

   $ 4.0    $ 2.2    $ 7.9    $ 4.5

Oncology

           

PXD101

   $ 4.0    $ 2.7    $ 6.6    $ 5.0

CR011-vcMMAE

   $ 0.7    $ 2.8    $ 1.4    $ 2.8

Kidney Inflammation

           

CR002

   $ 0.0    $ 0.1    $ 0.0    $ 0.1

 

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We expect that the direct research and development expenses incurred in connection with our development of velafermin to be consistent in 2007 as compared to 2006 due to our Phase II trial. We expect that the direct research and development expenses incurred in connection with our development of belinostat (PXD101) will increase in 2007 as compared to 2006. The expected increase during 2007 is related to higher enrollment of patients into our ongoing Phase I and Phase II clinical trials. We expect the CR011 expenses to decrease in 2007 as compared to 2006 due to the completion of manufacturing activities during 2006. We expect no material costs related to CR002 in 2007; we are seeking to license CR002 to a partner with the necessary resources and expertise required for developing this potential therapeutic.

Currently, our potential pharmaceutical products require significant research and development efforts, and will require extensive evaluation in clinical trials prior to submitting an application to regulatory agencies for their commercial use. Although we are conducting, or have conducted, human studies with respect to velafermin, belinostat (PXD101), CR011-vcMMAE, and CR002, we may not be successful in developing or commercializing these or other products. Our product candidates are subject to the risks of failure inherent in the development and commercialization of pharmaceutical products and we cannot currently provide reliable estimates as to when, if ever, our product candidates will generate revenue and cash flows.

Completion of research and development, preclinical testing and clinical trials may take many years. Estimates of completion periods for any of our major research and development projects are highly speculative and variable, and dependent on the nature of the disease indication, how common the disease is among the general populace, and the results of the research. For example, preclinical testing and clinical trials can often go on for an indeterminate period of time since the results of tests are continually monitored, with each test considered “complete” only when sufficient data has been accumulated to assess whether the next phases of clinical trials are warranted or whether the effort should be abandoned. Typically, Phase I clinical trials are expected to last between 12 and 24 months, Phase II clinical trials are expected to last between 24 and 36 months and Phase III clinical trials are expected to last between 24 and 60 months. The most significant time and costs associated with clinical development are the Phase III trials as they tend to be the longest and most comprehensive studies conducted during the drug development process.

In addition, many factors may delay the commencement and speed of completion of clinical trials, including, but not limited to, the number of patients participating in the trial, the duration of patient follow-up required, the number of clinical sites at which the trials are conducted, other products that are either approved or are in clinical trials that compete for the same population of patients, and the length of time required to locate and enroll suitable patient subjects. The successful completion of our development programs and the successful development of our product candidates are highly uncertain and are subject to numerous challenges and risks. Therefore, we cannot presently estimate anticipated completion dates for any of our projects.

Due to the variability in the length of time necessary to develop a product candidate, the uncertainties related to the cost of projects and the need to obtain governmental approval for commercialization, accurate and meaningful estimates of the ultimate costs to bring our product candidates to market are not available. If our major research and development projects are delayed, then we can expect to incur additional costs in conducting our clinical trials, and a longer period of time before we might achieve profitability from our operating activities. Accordingly, the timing of the potential market approvals for our existing product candidates, velafermin, belinostat (PXD101) and CR011-vcMMAE, may have a significant impact on our capital requirements.

General and administrative expenses. General and administrative expenses for the three months ended June 30, 2007, as compared to the three months ended June 30, 2006 remained relatively consistent. General and administrative expenses for the six months ended June 30, 2007, as compared to the six months ended June 30, 2006 increased slightly, primarily as a result of consulting and legal fees incurred in connection with the sale of our shares of 454. We anticipate our general and administrative expenses for the remaining two quarters of 2007 to remain consistent with the second quarter of 2007.

Restructuring charge. In June 2007, we underwent a corporate restructuring, to reduce operating costs and to focus resources on the advancement of our therapeutic pipeline through clinical development, resulting in an estimated total restructuring charge of approximately $8.4 million. During the second quarter of 2007, we recorded a restructuring charge of approximately $7.5 million. This amount includes an asset impairment charge of $6.0 million associated with the closure of our BPS, $1.3 million related to employee separation costs and $0.2 million of other asset write-offs. The employee separation costs were recorded under Statement of Financial Accounting Standards No. 146, “Accounting for Costs Associated with Exit or Disposal Activities”(“SFAS 146”), and included amounts to be paid for severance and related benefits, the services for which will be performed within a minimum retention period.

 

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At June 30, 2007, the BPS and certain other assets were classified as held for sale on the June 30, 2007 balance sheet. These assets are expected to generate sale proceeds of approximately $3.0 million during the second half of 2007.

Additional restructuring charges for severance and related benefits of approximately $0.7 million will be recorded during the second half of 2007, as they relate to services to be performed during the third and fourth quarters of 2007 by a small number of the approximately 40 affected employees who will be completing ongoing projects through the end of 2007.

In addition, pursuant to the terms of restricted stock agreements held by various employees being terminated in connection with the restructuring, the individual’s ownership of such restricted shares shall become immediately vested if we terminate the individual’s employment or service by way of an “involuntary termination”. Therefore, non-cash restructuring charges of $0.2 million will be recorded during the second half of 2007 as compensation expense with respect to the accelerated vesting of these restricted stock awards.

The cash requirements under the June 2007 restructuring plan are $2.0 million, none of which was paid prior to June 30, 2007. The majority of the remaining cash requirements of $2.0 million will be paid through December 2007.

Interest income. Interest income for the three and six month periods ended June 30, 2007 decreased as compared to the same periods in 2006, primarily due to lower average quarterly cash and investment balances, partially offset by higher yields on our investment portfolio. We earned an average yield of 4.1% during the second quarter of 2007 as compared to 3.9% in the second quarter of 2006, and earned an average yield of 4.0% during the first six months of 2007 as compared to 3.7% during the same period in 2006. We anticipate interest income to be approximately $5.0 million for the full year 2007 due to anticipated lower cash balances resulting from the utilization of cash and investment balances in the normal course of operations, as well as the repayment of $66.2 million of our 6% convertible subordinated debentures which occurred upon their maturity in February 2007, offset by the receipt of $82.0 million of proceeds from the sale of 454 (assuming full payment to us of our share of the proceeds currently being held in escrow to secure the indemnification rights of RDO and its affiliates). We also expect the yields in our investment portfolio to increase during the remainder of 2007.

Interest expense. Interest expense for the three and six month periods ended June 30, 2007 decreased as compared to the same period in 2006 due to the repayment of $66.2 million of our 6% convertible subordinated debentures which occurred upon their maturity in February 2007. We expect interest expense, including interest paid to debt holders as well as amortization of deferred financing costs, to be approximately $5 million for the full year 2007.

Income tax benefit. We recorded an income tax benefit during the three and six month periods ended June 30, 2007 and 2006 as a result of Connecticut legislation, which allows companies to obtain cash refunds from the State of Connecticut at a rate of 65% of their annual research and development expense credit, in exchange for forgoing carryforward of the research and development credit. We expect the 2007 income tax benefit to be less than 2006 (before adjustment to reflect statute of limitations expirations) due to an anticipated decrease in research and development expenses for the full year 2007 as compared to the full year 2006.

Loss from discontinued operations. Due to the disposition of 454 in the second quarter of 2007, the results of 454’s operations have been reclassified as discontinued operations for all periods presented. The increase in the loss from discontinued operations for the three and six month periods ended June 30, 2007 as compared to the same periods in 2006 was due to an increase in 454’s SFAS 123R compensation expense for the accelerated vesting of stock options in connection with the Merger, 454’s research and development expenses associated with additional personnel and lab supplies and an increase in general and administrative expenses primarily due to consulting and legal fees incurred in connection with the sale of 454 to RDO. These increases in expenses were partially offset by an increase in the profit 454 earned on product, grant and milestone revenue. During the third quarter of 2006, the cumulative losses applicable to the minority interest in subsidiary exceeded the minority interest in the equity capital of 454, therefore all losses applicable to the minority interest from the third quarter of 2006 through the closing of the sale of 454 to RDO on May 25, 2007 were charged to us.

Gain on sale of subsidiary. During May 2007, the sale of 454 to RDO closed and as a result we recognized a gain on the sale of our ownership in 454 of approximately $78.4 million.

 

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Liquidity and Capital Resources

Since our inception, we have financed our operations and met our capital expenditure requirements primarily through: private placements of equity securities; convertible subordinated debt offerings; public equity offerings; and revenues received under our collaborative research agreements. Since inception, we have not had any off-balance sheet arrangements. To date, inflation has not had a material effect on our business.

In June 2007, we underwent a corporate restructuring, to reduce operating costs and to focus resources on the advancement of our therapeutic pipeline through clinical development, resulting in an estimated total restructuring charge of approximately $8.4 million. During the second quarter of 2007, we recorded a restructuring charge of approximately $7.5 million. This amount includes an asset impairment charge of $6.0 million associated with the closure of our BPS, $1.3 million related to employee separation costs and $0.2 million of other asset write-offs. The employee separation costs were recorded under Statement of Financial Accounting Standards No. 146, “Accounting for Costs Associated with Exit or Disposal Activities” (“SFAS 146”), and included amounts to be paid for severance and related benefits, the services for which will be performed within a minimum retention period.

At June 30, 2007, the BPS and certain other assets were classified as held for sale on the June 30, 2007 balance sheet. These assets are expected to generate sale proceeds of approximately $3.0 million during the second half of 2007.

Additional restructuring charges for severance and related benefits of approximately $0.7 million will be recorded during the second half of 2007, as they relate to services to be performed during the third and fourth quarters of 2007 by a small number of the approximately 40 affected employees who will be completing ongoing projects through the end of 2007.

In addition, pursuant to the terms of restricted stock agreements held by various employees being terminated in connection with the restructuring, the individual’s ownership of such restricted shares shall become immediately vested if we terminate the individual’s employment or service by way of an “involuntary termination”. Therefore, non-cash restructuring charges of $0.2 million will be recorded during the second half of 2007 as compensation expense with respect to the accelerated vesting of these restricted stock awards.

The cash requirements under the June 2007 restructuring plan are $2.0 million, none of which was paid prior to June 30, 2007. The majority of the remaining cash requirements of $2.0 million will be paid through December 2007.

During May 2007, the sale of 454 to RDO closed and as a result we received net proceeds of $82.0 million, which included $14.1 million to be held in escrow for a period of 15 months after closing of the sale, or until August 25, 2008, to secure the indemnification rights of RDO and its affiliates. If RDO makes successful claims for indemnification, the $14.1 million held in escrow will be reduced in whole or in part. We intend to use the proceeds from this transaction to continue funding our business and the clinical trials being conducted on velafermin, belinostat (PXD101), and CR011-vcMMAE.

On February 2, 2007, we repaid at maturity the remaining $66.2 million balance of the 6% convertible subordinated debentures, plus accrued interest of $2.0 million.

Cash and investments. The following table depicts the components of our operating, investing and financing activities for the six month periods ended June 30, 2007 and 2006, using the direct cash flow method (in millions):

 

     Six months ended June 30,  
     2007     2006  

Cash received from collaborators

   $ 0.9     $ 0.5  

Cash paid to suppliers and employees

     (23.5 )     (23.9 )

Restructuring and related charges paid

     (0.4 )     (1.1 )

Interest income received

     2.2       3.7  

Interest expense paid

     (4.3 )     (4.3 )

Income tax benefit received

     0.4       1.1  
                

Net cash and investments used in operating activities

     (24.7 )     (24.0 )
                

Cash paid to acquire property and equipment

     (0.1 )     (0.1 )

Proceeds from sale of fixed assets

     —         0.1  

Proceeds from sale of held for sale assets

     81.4       —    

Restricted cash

     (14.1 )     —    
                

Net cash and investments provided by investing activities

     67.2       —    
                

Cash received from employee stock option exercises

     0.1       0.3  

Cash paid for extinguishment of debt

     (66.2 )     —    
                

Net cash and investments (used in) provided by financing activities

     (66.1 )     0.3  
                

Unrealized gain (loss) on short-term investments and marketable securities

     0.3       (0.5 )
                

Net decrease in cash and investments

     (23.3 )     (24.2 )

Cash and investments, beginning of period

     164.4       211.2  
                

Cash and investments, end of period

   $ 141.1     $ 187.0  
                

 

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In accordance with our investment policy, we are utilizing the following investment objectives for cash and investments: (1) investment decisions are made with the expectation of minimum risk of principal loss, even with a modest penalty in yield; (2) appropriate cash balances and related short-term funds are maintained for immediate liquidity needs, and appropriate liquidity is available for medium-term cash needs; and (3) maximum yield is achieved.

Future Liquidity. During the next 24 months we expect to continue to fund our operations through a combination of the following sources: cash and investment balances; interest income; potential public securities offerings; and/or private strategic-driven transactions. At June 30, 2007, $3.0 million of assets under the June 2007 restructuring are expected to be sold during the second half of 2007. During May 2007, the sale of 454 to RDO closed and we received net proceeds of $82.0 million, which included $14.1 million to be held in escrow for a period of 15 months after closing of the merger. We plan to use the proceeds to continue generating clinical trial results from our three late stage oncology programs, velafermin, belinostat (PXD101) and CR011-vcMMAE, which will potentially enable us to bring one or more of these products into registrational or Phase III trials during 2008. On February 2, 2007, we repaid the remaining $66.2 million balance of the 6% convertible subordinated debentures plus accrued interest of $2.0 million. We plan to continue making substantial investments to advance our clinical drug pipeline. We do not anticipate any material capital expenditures in the near future. Accordingly, we foresee the following as significant uses of liquidity: contractual services related to clinical trials and manufacturing; salary and benefits; perpetual license fees; potential milestone payments; and payments of interest to the holders of our convertible subordinated debt due in 2011.

We may use sources of liquidity for working capital, and for general corporate purposes and potentially for future acquisitions of complementary businesses or products or technologies. The amounts and timing of our actual expenditures will depend upon numerous factors, including the amount and extent of our acquisitions, our product development activities, and our investments in technology and the amount of cash generated by our operations. Actual expenditures may vary substantially from our estimates. Our failure to use sources of liquidity effectively could have a material adverse effect on our business, results of operations and financial condition.

We believe that our existing cash and investment balances and other sources of liquidity will be sufficient to meet our requirements for the next 24 months. We consider our operating and capital expenditures to be crucial to our future success, and by continuing to make strategic investments in our clinical drug pipeline, we believe that we are building substantial value for our shareholders. The adequacy of our available funds to meet our future operating and capital requirements, including the repayment of the $110.0 million of 4% convertible subordinated notes due February 15, 2011, will depend on many factors. These factors include: the number, breadth, progress and results of our research, product development and clinical programs; the costs and timing of obtaining regulatory approvals for any of our products; in-licensing and out-licensing of pharmaceutical products; costs incurred in enforcing and defending our patent claims; and other intellectual property rights and the extent to which RDO makes successful claims for indemnification under the Merger Agreement relating to the sale of 454.

While we will continue to explore alternative sources for financing our business activities, including the possibility of public securities offerings and/or private strategic-driven common stock offerings, we cannot be certain that in the future these sources of liquidity will be available when needed or that our actual cash requirements will not be greater than anticipated. In appropriate strategic situations, we may seek financial assistance from other sources, including contributions by others to joint ventures and other collaborative or licensing arrangements for the development and testing of products under development. However, should we be unable to obtain future financing either through the methods described above or through other means, we may be unable to meet the critical objective of our long-term business plan, which is to successfully develop and market pharmaceutical products, and may be unable to continue operations. This result could cause our shareholders to lose all or a substantial portion of their investment.

 

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Contractual Obligations

In the table below, we set forth our enforceable and legally binding obligations, along with future commitments related to all contracts that we are likely to continue, regardless of the fact that they are cancelable as of June 30, 2007. As compared to the Contractual Obligations disclosure in our Annual Report on Form 10-K for the year ended December 31, 2006, this table no longer includes 454, which was sold in May 2007.

Some of the amounts we include in this table under purchase commitments are based on management’s estimates and assumptions about these obligations, including their duration, anticipated actions by third parties, progress of our clinical programs and other factors.

 

     Payments Due Year Ended December 31,
     Total    2007    2008    2009    2010    2011

Long-term debt obligations

   $ 110.0    $ —      $ —      $ —      $ —      $ 110.0

Interest on convertible subordinated debt

     17.6      2.2      4.4      4.4      4.4      2.2

Operating leases

     1.7      1.0      0.7      —        —        —  

Purchase commitments

     13.4      7.2      5.7      0.5      —        —  
                                         

Total

   $ 142.7    $ 10.4    $ 10.8    $ 4.9    $ 4.4    $ 112.2
                                         

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Our outstanding long-term liabilities as of June 30, 2007 include $110.0 million of our 4% convertible subordinated notes due February 15, 2011. As the debentures and notes bear interest at a fixed rate, our results of operations are not affected by interest rate changes. As of June 30, 2007, the market value of our $110.0 million 4% convertible subordinated notes due 2011, based on quoted market prices, was approximately $83.0 million. Although future borrowings may bear interest at a floating rate, and would therefore be affected by interest rate changes, at this point we do not anticipate any significant future borrowings at floating interest rates, and therefore do not believe that a change of 100 basis points in interest rates would have a material effect on our financial condition.

There have been no other significant changes in our market risk compared to the disclosures in Item 7A of our Annual Report on Form 10-K for the year ended December 31, 2006.

Item 4. Controls and Procedures

 

  (a) Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our chief executive officer and chief financial officer, evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2007. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act of 1934, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act of 1934 is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of June 30, 2007, our chief executive officer and chief financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

 

  (b) Changes in Internal Controls

No change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the fiscal quarter ended June 30, 2007 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

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Part II - Other Information

Item 1A. Risk Factors

Statements contained or incorporated by reference in this Quarterly Report on Form 10-Q that are not based on historical fact are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act. These forward-looking statements regarding future events and our future results are based on current expectations, estimates, forecasts, and projections and the beliefs and assumptions of our management including, without limitation, our expectations regarding results of operations, selling, general and administrative expenses, research and development expenses, the sufficiency of our cash for future operations, and the success of our preclinical, clinical and development programs. Forward-looking statements may be identified by the use of forward-looking terminology such as “may,” “could,” “will,” “expect,” “estimate,” “anticipate,” “continue,” or similar terms, variations of such terms or the negative of those terms.

We cannot assure investors that our assumptions and expectations will prove to have been correct. Important factors could cause our actual results to differ materially from those indicated or implied by forward-looking statements. Such factors that could cause or contribute to such differences include those factors discussed below. We undertake no intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. If any of the following risks actually occur, our business, financial condition, results of operations or liquidity would likely suffer.

The following discussion includes revised risk factors that reflect developments subsequent to the discussion of risk factors included in our most recent Annual Report on Form 10-K, including the closing of the sale of our stake in 454 to RDO on May 25, 2007. Due to the completion of the sale of 454 to RDO, we have excluded the risk factors related to 454’s business and added two risk factors addressing risks to us associated with the sale of 454. A detailed discussion of the 454 sale can be found in Note 4 to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.

Risks Related to Our Business

Substantially all of our gross consolidated revenue for the year ended December 31, 2006 was derived from sales by 454. As a result of the acquisition of 454 by RDO, we will have no meaningful source of recurring revenue in the near future.

In fiscal year 2006, approximately 94% of our gross consolidated revenues were derived from product, sequencing service, collaboration, grant and milestone revenue from 454. As a result of the acquisition of 454 by RDO, our revenue sources now consist primarily of limited amounts of collaboration revenue related to the LEO Pharma/TopoTarget licensing agreement. Accordingly, we have no meaningful source of recurring revenue for the short term.

We have a history of operating losses and expect to incur operating losses in the future.

We have incurred losses since inception, principally as a result of research and development and general and administrative expenses in support of our operations. We experienced net losses of $59.8 million in 2006, $73.2 million in 2005 and $90.4 million in 2004, and as of June 30, 2007 had an accumulated deficit of $475.1 million. During the six months ended June 30, 2007, we reported net income of $37.9 million, as a result of the gain on the sale of our stake in 454. We anticipate incurring additional losses as we focus our resources on prioritizing, selecting, and advancing our most promising drug candidates. We may never have operating income or achieve significant revenues.

We can not ensure that our existing cash and investment balances will be sufficient to meet our requirements for the future.

We believe that our existing cash and investment balances and other sources of liquidity, will be sufficient to meet our requirements for the next 24 months. We consider our operating and capital expenditures to be crucial to our future success, and by continuing to make strategic investments in our clinical drug pipeline, we believe that we are building substantial value for our stockholders. The adequacy of our available funds to meet our future operating and capital requirements will depend on many factors. These factors include: the number, breadth, progress and results of our research, product development and clinical programs; the costs and timing of obtaining regulatory approvals for any of our products; in-licensing and out-licensing of pharmaceutical products; and costs incurred in enforcing and defending our patent claims and other intellectual property rights.

 

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While we will continue to explore alternative sources for financing our business activities, including the possibility of public securities offerings and/or private strategic-driven common stock offerings, we cannot be certain that in the future these sources of liquidity will be available when needed or that our actual cash requirements will not be greater than anticipated. In appropriate strategic situations, we may seek financial assistance from other sources, including contributions by others to joint ventures and other collaborative or licensing arrangements for the development and testing of products under development. However, should we be unable to obtain future financing either through the methods described above or through other means, we may be unable to meet the critical objective of our long-term business plan, which is to successfully develop and market pharmaceutical products, and may be unable to continue operations. This result could cause our stockholders to lose all or a substantial portion of their investment.

All of our drug candidates are still in the early stages of development and remain subject to clinical testing and regulatory approval. If we are unable to successfully develop and test our drug candidates, we will not be successful.

To date, we have not marketed, distributed or sold any drug candidates. The success of our business depends primarily upon our ability to develop and commercialize our drug candidates successfully. Our most advanced drug candidates are velafermin, which is currently in a Phase II clinical trial, belinostat (PXD101), which is in multiple Phase I and Phase II clinical trials, CR011-vcMMAE, which is currently in a Phase I/II clinical trial, and CR002, which completed a Phase I clinical trial in July 2005. Further development of our other preclinical candidates will be limited in the foreseeable future due to our decision to focus our resources on the development of our clinical oncology therapeutics. Our drug candidates must satisfy rigorous standards of safety and efficacy before they can be approved for sale. To satisfy these standards, we must engage in expensive and lengthy testing and obtain regulatory approval of our drug candidates. Despite our efforts, our drug candidates may not:

 

   

offer therapeutic or other improvement over existing comparable drugs;

 

   

be proven safe and effective in clinical trials;

 

   

meet applicable regulatory standards;

 

   

be capable of being produced in commercial quantities at acceptable costs; or

 

   

be successfully commercialized.

Positive results in preclinical studies of a drug candidate may not be predictive of similar results in humans during clinical trials, and promising results from early clinical trials of a drug candidate may not be replicated in later clinical trials. A number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in late stage clinical trials even after achieving promising results in early stage development. Accordingly, the results from the completed preclinical studies and clinical trials and ongoing clinical trials for velafermin, belinostat (PXD101), CR011-vcMMAE and our other drug candidates may not be predictive of the safety, efficacy or dosing results we may obtain in later stage trials. We do not expect any of our drug candidates to be commercially available for at least several years.

If we are unable to obtain U.S. and/or foreign regulatory approval, we will be unable to commercialize our drug candidates.

Our drug candidates are subject to extensive governmental regulations relating to development, clinical trials, manufacturing and commercialization. Rigorous preclinical testing and clinical trials and an extensive regulatory approval process are required in the United States and in many foreign jurisdictions prior to the commercial sale of our drug candidates. Satisfaction of these and other regulatory requirements is costly, time consuming, uncertain and subject to unanticipated delays. It is possible that none of the drug candidates we are developing will obtain marketing approval. In connection with the clinical trials for velafermin, belinostat (PXD101), CR011-vcMMAE and any other drug candidate we may seek to develop in the future, we face risks that:

 

   

the drug candidate may not prove to be efficacious;

 

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the drug may not prove to be safe;

 

   

the results may not confirm the positive results from earlier preclinical studies or clinical trials; and

 

   

the results may not meet the level of statistical significance required by the FDA or other regulatory authorities.

We have limited experience in conducting and managing the clinical trials necessary to obtain regulatory approvals, including approval by the FDA. The time required to complete clinical trials and for the FDA and other countries’ regulatory review processes is uncertain and typically takes many years. Our analysis of data obtained from preclinical and clinical activities is subject to confirmation and interpretation by regulatory authorities, which could delay, limit or prevent regulatory approval. We may also encounter unanticipated delays or increased costs due to government regulation from future legislation or administrative action or changes in FDA policy during the period of product development, clinical trials and FDA regulatory review.

Any delay in obtaining, or failure to obtain, required approvals could materially adversely affect our ability to generate revenues from the particular drug candidate. Furthermore, any regulatory approval to market a product may be subject to limitations on the indicated uses for which we may market the product. These limitations may limit the size of the market for the product. We are also subject to numerous foreign regulatory requirements governing the conduct of clinical trials, manufacturing and marketing authorization, pricing and third-party reimbursement. The foreign regulatory approval process includes all of the risks associated with FDA approval described above as well as risks attributable to the satisfaction of foreign requirements. Approval by the FDA does not ensure approval by regulatory authorities outside the United States. Foreign jurisdictions may have different approval procedures than those required by the FDA and may impose additional testing requirements for our drug candidates.

If clinical trials for our drug candidates are prolonged or delayed, we may be unable to commercialize our drug candidates on a timely basis, which would require us to incur additional costs and delay our receipt of any product revenue.

We cannot predict whether we will encounter problems with any of our completed, ongoing or planned clinical trials that will cause us or regulatory authorities to delay or suspend clinical trials, or delay the analysis of data from our completed or ongoing clinical trials. Any of the following could delay the clinical development of our drug candidates:

 

   

ongoing discussions with the FDA or comparable foreign authorities regarding the scope or design of our clinical trials;

 

   

delays in receiving or the inability to obtain required approvals from institutional review boards or other reviewing entities at clinical sites selected for participation in our clinical trials;

 

   

delays in enrolling volunteers and patients into clinical trials;

 

   

a lower than anticipated retention rate of volunteers and patients in clinical trials;

 

   

the need to repeat clinical trials as a result of inconclusive or negative results or unforeseen complications in testing;

 

   

inadequate supply or deficient quality of drug candidate materials or other materials necessary for the conduct of our clinical trials;

 

   

unfavorable FDA inspection and review of a clinical trial site or records of any clinical or preclinical investigation;

 

   

serious and unexpected drug-related side effects experienced by participants in our clinical trials; or

 

   

the placement by the FDA of a clinical hold on a trial.

 

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Our ability to enroll patients in our clinical trials in sufficient numbers and on a timely basis will be subject to a number of factors, including the size of the patient population, the nature of the protocol, the proximity of patients to clinical sites, the availability of effective treatments for the relevant disease and the eligibility criteria for the clinical trial. Delays in patient enrollment may result in increased costs and longer development times. In addition, subjects may withdraw from our clinical trials, and thereby impair the validity or statistical significance of the trials.

We, the FDA or other applicable regulatory authorities may suspend clinical trials of a drug candidate at any time if we or they believe the subjects or patients participating in such clinical trials are being exposed to unacceptable health risks or for other reasons.

We cannot predict whether any of our drug candidates will encounter problems during clinical trials which will cause us or regulatory authorities to delay or suspend these trials, or which will delay the analysis of data from these trials. In addition, it is impossible to predict whether legislative changes will be enacted, or whether FDA regulations, guidance or interpretations will be changed, or what the impact of such changes, if any, may be. If we experience any such problems, we may not have the financial resources to continue development of the drug candidate that is affected or the development of any of our other drug candidates.

Even if we obtain regulatory approvals, our drug candidates will be subject to ongoing regulatory review. If we fail to comply with continuing U.S. and applicable foreign regulations, we could lose those approvals, and our business would be seriously harmed.

Even if we receive regulatory approval of any drugs we may develop, we will be subject to continuing regulatory review, including the review of clinical results which are reported after our drug candidates become commercially available approved drugs. Since drugs are more widely used by patients once approval has been obtained, side effects and other problems may be observed after approval that were not seen or anticipated during pre-approval clinical trials. In addition, the manufacturer, and the manufacturing facilities we use to make any of our drug candidates, will also be subject to periodic review and inspection by the FDA. The subsequent discovery of previously unknown problems with the drug, manufacturer or facility may result in restrictions on the drug, manufacturer or facility, including withdrawal of the drug from the market. If we fail to comply with applicable continuing regulatory requirements, we may be subject to fines, suspension or withdrawal of regulatory approval, product recalls and seizures, operating restrictions and criminal prosecutions.

Our business has a substantial risk of product liability claims. If we are unable to obtain appropriate levels of insurance, a product liability claim could adversely affect our business.

Our business exposes us to significant potential product liability risks that are inherent in the development, manufacturing and sales and marketing of human therapeutic products. Although we do not currently commercialize any products, claims could be made against us based on the use of our drug candidates in clinical trials. We currently have clinical trial insurance and will seek to obtain product liability insurance prior to the sales and marketing of any of our drug candidates. However, our insurance may not provide adequate coverage against potential liabilities. Furthermore, clinical trial and product liability insurance is becoming increasingly expensive. As a result, we may be unable to maintain current amounts of insurance coverage or obtain additional or sufficient insurance at a reasonable cost to protect against losses that could have a material adverse effect on us. If a claim is brought against us, we might be required to pay legal and other expenses to defend the claim, as well as uncovered damages awards resulting from a claim brought successfully against us. Furthermore, whether or not we are ultimately successful in defending any such claims, we might be required to direct significant financial and managerial resources to such defense, and adverse publicity is likely to result.

If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our drug candidates, we may not generate product revenue.

We have no commercial products and we do not currently have an organization for the sales and marketing of pharmaceutical products. In order to successfully commercialize any drugs that may be approved in the future by the FDA or comparable foreign regulatory authorities, we must build our sales and marketing capabilities or make arrangements with third parties to perform these services. There are risks involved with establishing our own sales and marketing capabilities, as well as entering into arrangements with third parties to perform these services. For example, developing a sales force is expensive and time consuming and could delay any product launch. In addition, to the extent that we enter into arrangements with third parties to perform sales, marketing and distribution services, we will have less control over sales of our products, and our future revenues would depend heavily on the success of the efforts of these third parties. If we are unable to establish adequate sales, marketing and distribution capabilities, whether independently or with third parties, we may not be able to generate product revenue and may not become profitable.

 

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If physicians, patients and third-party payors do not accept our future drugs, we may be unable to generate significant revenue, if any.

Even if velafermin, belinostat (PXD101), CR011-vcMMAE or any other drug candidates we may develop or acquire in the future obtain regulatory approval, they may not gain market acceptance among physicians, patients and health care payors. Physicians may elect not to recommend these drugs for a variety of reasons including:

 

   

timing of market introduction of competitive drugs;

 

   

lower demonstrated clinical safety and efficacy compared to other drugs;

 

   

lack of cost-effectiveness;

 

   

lack of availability of reimbursement from third-party payors;

 

   

convenience and ease of administration;

 

   

prevalence and severity of adverse side effects;

 

   

other potential advantages of alternative treatment methods; and

 

   

ineffective marketing and distribution support.

If our approved drugs fail to achieve market acceptance, we would not be able to generate sufficient revenue from product sales to maintain or grow our business.

If third-party payors do not adequately reimburse customers for any of our product candidates that are approved for marketing, they might not be purchased or used, and our revenues and profits will not develop or increase.

Our revenues and profits will depend heavily upon the availability of adequate reimbursement for the use of our approved product candidates from governmental and other third-party payors, both in the United States and in foreign markets. Reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’s determination that use of a product is:

 

   

a covered benefit under its health plan;

 

   

safe, effective and medically necessary;

 

   

appropriate for the specific patient;

 

   

cost-effective; and

 

   

neither experimental nor investigational.

 

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Obtaining reimbursement approval for a product from each government or other third-party payor is a time-consuming and costly process that could require us to provide supporting scientific, clinical and cost-effectiveness data for the use of our products to each payor. We may not be able to provide data sufficient to gain acceptance with respect to reimbursement. There is substantial uncertainty whether any particular payor will reimburse the use of any drug products incorporating new technology. Even when a payor determines that a product is eligible for reimbursement, the payor may impose coverage limitations that preclude payment for some uses that are approved by the FDA or comparable authority. Moreover, eligibility for coverage does not imply that any product will be reimbursed in all cases or at a rate that allows us to make a profit or even cover our costs. Interim payments for new products, if applicable, may also not be sufficient to cover our costs and may not be made permanent. Reimbursement rates may vary according to the use of the product and the clinical setting in which it is used, may be based on payments allowed for lower-cost products that are already reimbursed, may be incorporated into existing payments for other products or services, and may reflect budgetary constraints and/or imperfections in Medicare, Medicaid or other data used to calculate these rates. Net prices for products may be reduced by mandatory discounts or rebates required by government health care programs or by any future relaxation of laws that restrict imports of certain medical products from countries where they may be sold at lower prices than in the United States.

There have been, and we expect that there will continue to be, federal and state proposals to constrain expenditures for medical products and services, which may affect payments for our products. The Centers for Medicare and Medicaid Services, or CMS, frequently change product descriptors, coverage policies, product and service codes, payment methodologies and reimbursement values. Third-party payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates, and both CMS and other third-party payors may have sufficient market power to demand significant price reductions. Due in part to actions by third-party payors, the health care industry is experiencing a trend toward containing or reducing costs through various means, including lowering reimbursement rates, limiting therapeutic class coverage and negotiating reduced payment schedules with service providers for drug products.

Our inability to promptly obtain coverage and profitable reimbursement rates from government-funded and private payors for our products could have a material adverse effect on our operating results and our overall financial condition.

We may not be able to execute our business strategy if we are unable to enter into alliances with other companies that can provide capabilities and funds for the development and commercialization of our drug candidates. If we are unsuccessful in forming or maintaining these alliances on favorable terms, our business may not succeed.

We have entered into collaboration arrangements with several companies for the research, development and commercialization of our drug candidates, and we may enter into additional collaborative arrangements in the future. For example, we may enter into alliances with major biotechnology or pharmaceutical companies to jointly develop specific drug candidates and to jointly commercialize them if they are approved. We may not be successful in entering into any such alliances on favorable terms. Even if we do succeed in securing such alliances, we may not be able to maintain them if, for example, development or approval of a drug candidate is delayed or sales of an approved drug are disappointing. Furthermore, any delay in entering into collaboration agreements could delay the development and commercialization of our drug candidates and reduce their competitiveness even if they reach the market. Any such delay related to our collaborations could adversely affect our business.

In addition to relying on a third party for its capabilities, we may depend on our alliances with other companies to provide substantial additional funding for development and potential commercialization of our drug candidates. We may not be able to obtain funding on favorable terms from these alliances, and if we are not successful in doing so, we may not have sufficient funds to develop a particular drug candidate internally, or to bring drug candidates to market. Failure to bring our drug candidates to market will prevent us from generating sales revenues, and this may substantially harm our business.

If a collaborative partner terminates or fails to perform its obligations under agreements with us, the development and commercialization of our drug candidates could be delayed or terminated.

If any current or future collaborative partner does not devote sufficient time and resources to collaboration arrangements with us, we may not realize the potential commercial benefits of the arrangement, and our results of operations may be adversely affected. In addition, if any existing or future collaboration partner were to breach or terminate its arrangements with us, the development and commercialization of the affected drug candidate could be delayed, curtailed or terminated because we may not have sufficient financial resources or capabilities to continue development and commercialization of the drug candidate on our own.

 

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Much of the potential revenue from our existing and future collaborations will consist of contingent payments, such as payments for achieving development milestones and royalties payable on sales of drugs developed using our technologies. The milestone and royalty revenues that we may receive under these collaborations will depend upon our collaborator’s ability to successfully develop, introduce, market and sell new products. In addition, our collaborators may decide to enter into arrangements with third parties to commercialize products developed under our existing or future collaborations using our technologies, which could reduce the milestone and royalty revenue that we may receive, if any. In many cases we will not be involved in these processes and accordingly will depend entirely on our collaborators. Our collaboration partners may fail to develop or effectively commercialize products using our products or technologies because they:

 

   

decide not to devote the necessary resources due to internal constraints, such as limited personnel with the requisite scientific expertise, limited cash resources or specialized equipment limitations, or the belief that other drug development programs may have a higher likelihood of obtaining regulatory approval or may potentially generate a greater return on investment;

 

   

do not have sufficient resources necessary to carry the drug candidate through clinical development, regulatory approval and commercialization;

 

   

decide to pursue a competitive drug candidate developed outside of the collaboration; or

 

   

cannot obtain the necessary regulatory approvals.

If our collaboration partners fail to develop or effectively commercialize drug candidates or drugs for any of these reasons, we may not be able to replace the collaboration partner with another partner to develop and commercialize a drug candidate or drugs under the terms of the collaboration. We may also be unable to obtain a license from such collaboration partner on terms acceptable to us, or at all.

We rely on third parties to conduct our clinical trials and provide other services, and those third parties may not perform satisfactorily, including failing to meet established deadlines for the completion of such services.

We do not have the ability to independently conduct some preclinical studies and the clinical trials for our drug candidates, and we rely on third parties such as contract laboratories, contract research organizations, medical institutions and clinical investigators to design and conduct these studies and our clinical trials. Our reliance on these third parties reduces our control over these activities. Accordingly, these third-party contractors may not complete activities on schedule, or may not conduct the studies or our clinical trials in accordance with regulatory requirements or our trial design. To date, we believe our contract research organizations and other similar entities with which we are working have performed well. However, if these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may be required to replace them. Although we believe that there are a number of other third-party contractors we could engage to continue these activities, it may result in delays. Accordingly, our efforts to obtain regulatory approvals for and commercialize our drug candidates may be delayed.

In addition, our ability to bring our future products to market depends on the quality and integrity of the data we present to regulatory authorities in order to obtain marketing authorizations. We cannot guarantee the authenticity or accuracy of such data, nor can we be certain that such data has not been fraudulently generated. The failure of these third parties to carry out their obligations would materially adversely affect our ability to develop and market new products and implement our strategies.

We currently depend on third-party manufacturers to produce our clinical drug supplies and intend to rely upon third-party manufacturers to produce commercial supplies of any approved drug candidates. If in the future we manufacture any of our drug candidates, we will be required to incur significant costs and devote significant efforts to establish and maintain these capabilities.

We have relied upon third parties to produce material for clinical testing purposes and intend to continue to do so in the future. Although we believe that we will not have any material supply issues, we cannot be certain that we will be able to obtain long-term supplies of those materials on acceptable terms, if at all. We also expect to rely upon third parties to produce materials required for the commercial production of our drug candidates if we succeed in obtaining necessary regulatory approvals. If we are unable to arrange for third-party manufacturing, or to do so on commercially reasonable terms, we may not be able to complete development of our drug candidates or market them. Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured drug candidates ourselves, including reliance on the third party for regulatory compliance and quality assurance, the possibility of breach of the manufacturing agreement by the third party because of factors beyond our control and the possibility of termination or nonrenewal of the agreement by the third party, based on its own business priorities,

 

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at a time that is costly or damaging to us. In addition, the FDA and other regulatory authorities require that our drug candidates be manufactured according to current Good Manufacturing Practices, or cGMP, regulations. Any failure by us or our third-party manufacturers to comply with cGMP and/or our failure to scale up our manufacturing processes could lead to a delay in, or failure to obtain, regulatory approval of any of our drug candidates. In addition, such failure could be the basis for action by the FDA to withdraw approvals for drug candidates previously granted to us and for other regulatory action.

We currently rely on a single manufacturer for the clinical supplies of our protein, antibody, and ADC drug candidates and do not currently have relationships for redundant supply or a second source for any of these drug candidates. To date, our third-party manufacturers have met our manufacturing requirements, but we cannot assure that they will continue to do so. Any performance failure on the part of our existing or future manufacturers could delay clinical development or regulatory approval of our drug candidates or commercialization of any approved products. If for some reason our current contract manufacturers cannot perform as agreed, we may be required to replace them. Although we believe there are a number of potential replacements as our manufacturing processes are not manufacturer specific, we may incur added costs and delays in identifying and qualifying any such replacements. Furthermore, although we generally do not begin a clinical trial unless we believe we have a sufficient supply of a drug candidate to complete the trial, any significant delay in the supply of a drug candidate for an ongoing trial due to the need to replace a third-party manufacturer could delay completion of the trial.

We may in the future elect to manufacture certain of our drug candidates in our own manufacturing facilities. If we do so, we will require substantial additional funds and need to recruit qualified personnel in order to build or lease and operate any manufacturing facilities.

Because we have limited experience in developing, commercializing and marketing products, we may be unsuccessful in our efforts to do so.

Our products in development will require significant research and development and preclinical and clinical testing prior to our submitting any regulatory application for their commercial use. These activities, even if undertaken without the collaboration of others, will require us to expend significant funds and will be subject to the risks of failure inherent in the development of pharmaceutical products. We have limited experience conducting clinical trials. Even if we complete such studies, our ability to commercialize products will depend on our ability to:

 

   

obtain and maintain necessary intellectual property rights to our products;

 

   

enter into arrangements with third parties to manufacture our products on our behalf; and

 

   

deploy sales and marketing resources effectively or enter into arrangements with third parties to provide these services.

As a result of these possibilities, we may not be able to develop any commercially viable products. In addition, should we choose to develop pharmaceutical products internally, we will have to make significant investments in pharmaceutical product development, marketing, sales, and regulatory compliance resources, and we will have to establish or contract for the manufacture of products under the FDA cGMPs. Any potential products developed by our licensees will be subject to the same risks.

We do not currently have any marketed products. If we develop products that can be marketed, we intend to market the products either independently or together with collaborators or strategic partners. If we decide to market any products independently, we will incur significant additional expenditures and commit significant additional management resources to establish a sales force. For any products that we market together with partners, we will rely, in whole or in part, on the marketing capabilities of those parties. We may also contract with other third parties to market certain of our products. Ultimately, we and our partners may not be successful in marketing our products.

Because neither we nor any of our collaborative partners have received marketing approval for any product resulting from our research and development efforts, and may never be able to obtain any such approval, we may not be able to generate any product revenue.

All of the products being developed by our collaborative partners will require additional research and development, extensive preclinical studies and clinical trials, and regulatory approval prior to any commercial sales. In some cases, the length of time that it takes for our collaborative partners to achieve various regulatory approval milestones may affect the payments that we are eligible to receive under our collaboration agreements. We and our collaborative partners may need to address a number of technical challenges successfully in order to complete

 

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development of our drug candidates. Moreover, these drug candidates may not be effective in treating any disease or may prove to have undesirable or unintended side effects, toxicities, or other characteristics that may preclude our obtaining regulatory approval or prevent or limit commercial use.

We rely significantly on our collaborative partners to gain access to specified technologies and our business could be harmed if we are unable to maintain strategic alliances.

As part of our business strategy, we have strategic research and development alliances with companies to gain access to specific technologies. These alliances with other pharmaceutical and biotechnology companies may provide us with access to unique technologies, access to capital, near-term revenues, milestone and/or royalty payments, and potential profit sharing arrangements. In return, we provide access to unique technologies, expertise in genomics, and information on the molecular basis of disease, drug targets, and drug candidates. We currently have significant strategic alliances with Amgen Fremont, TopoTarget, Seattle Genetics, and Bayer in addition to numerous smaller agreements to facilitate these efforts. In these strategic alliances, either party can terminate the agreement at any time the alliance permits them to or if either party materially breaches the contract. We may not be able to maintain or expand existing alliances or establish any additional alliances. If any of our existing collaborators were to breach or terminate their agreements with us or otherwise fail to conduct activities successfully and in a timely manner, the preclinical or clinical development or commercialization of product candidates or research programs may be delayed or terminated, which may materially and adversely affect our business, financial condition, and results of operations.

We depend on attracting and retaining key employees.

We are highly dependent on the principal members of our senior management and scientific staff. Our future success will depend in part on the continued services of our key management and scientific personnel. The loss of services of any of these personnel could materially adversely affect our business, financial condition, and results of operations. We have entered into employment agreements with all of the principal members of our senior management team. Our future success will also depend in part on our ability to attract, hire, and retain additional personnel. There is intense competition for qualified personnel and there can be no assurance that we will be able to continue to attract and retain such personnel. Failure to attract and retain key personnel could materially, adversely affect our business, financial condition, and results of operations.

We depend on academic collaborators, consultants, and scientific advisors.

We have relationships with collaborators, consultants, and scientific advisors at academic and other institutions that conduct research or provide consulting services at our request. These collaborators, consultants, and scientific advisors are not our employees. Substantially all of our collaborators, consultants, and scientific advisors are employed by employers other than us and may have commitments to, or collaboration, consulting, or advisory contracts with, other entities that may limit their availability to us. As a result, we have limited control over their activities and, except as otherwise required by our collaboration, consulting agreements, and advisory agreements, can expect only limited amounts of their time to be dedicated to our activities. Our ability to explore and validate biological activity of therapeutic candidates and commercialize products based on these discoveries may depend, in part, on continued collaborations with researchers at academic and other institutions. We may not be able to negotiate additional acceptable collaborations with collaborators, consultants, or scientific advisors at academic and other institutions.

Our academic collaborators, consultants, and scientific advisors may have relationships with other commercial entities, some of which could compete with us. Our academic collaborators, consultants and scientific advisors sign agreements which provide for confidentiality of our proprietary information and of the results of studies. We may not be able to maintain the confidentiality of our technology and other confidential information in connection with every academic collaboration, consulting, or advisory arrangement, and any unauthorized dissemination of our confidential information could materially adversely affect our business, financial condition, and results of operations. Further, any such collaborator, consultant or advisor may enter into an employment agreement or consulting arrangement with one of our competitors.

Competition in our field is intense and likely to increase.

We are subject to significant competition in the development and commercialization of new drugs from organizations that are pursuing strategies, approaches, technologies and products that are similar to our own. Many

 

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of the organizations competing with us have greater capital resources, research and development staffs and facilities and marketing capabilities. We face competition from a number of biotechnology and pharmaceutical companies with products in preclinical development, clinical trials, or approved for conditions identical or similar to the ones we are pursuing.

We are aware of specific companies that are developing HDAC inhibitors for use in the treatment of cancer that may be competitive with ours. With respect to our HDAC inhibitor, belinostat (PXD101), Merck & Co., Inc. recently received FDA approval to market Zolinza, or vorinostat, the first HDAC inhibitor approved for use in the U.S., for the treatment of cutaneous T-cell lymphoma. Bayer Schering Pharma AG, Gloucester Pharmaceuticals, Inc., Methylgene, Inc., and Novartis Pharma AG are also currently evaluating HDAC inhibitors in clinical trials for the treatment of cancers, and in combinations with other chemotherapies, that are similar to approaches and indications we are pursuing. In addition, many other pharmaceutical and biotechnology companies are engaged in research and development for the treatment of cancer from which we may face intense competition. We expect to compete in the case of belinostat, on the basis of efficacy, routes of administration, and potentially safety and economic value compared to drugs used in current practice or currently being developed.

We expect that our fibroblast growth factor, velafermin, will compete with Kepivance, a keratinocyte growth factor, marketed by Amgen, Inc. for the prevention of severe OM in patients undergoing HSCT. We expect to compete in the case of velafermin, on the basis of efficacy, mechanism of action, ease of administration, and potentially economic value compared to drugs used in current practice or currently being developed.

If we do not obtain adequate intellectual property protection, we may not be able to prevent our competitors from commercializing our discoveries.

Our business and competitive position depends on our ability to protect our products and processes, including obtaining patent protection on genes and proteins for which we or our collaborators discover utility, and on products, methods and services based on such discoveries.

The patent positions of pharmaceutical, biopharmaceutical, and biotechnology companies, including us, are generally uncertain and involve complex legal and factual questions. The law relating to the scope of patent claims in the technology fields in which we operate is evolving, and the degree of future protection for our proprietary rights is uncertain. Furthermore, even if patents are issued to us, there can be no assurance that others will not develop alternative technologies or design around the patented technologies developed by us. Therefore, our patent applications may not protect our products, processes, and technologies for at least the following reasons:

 

   

there is no guarantee that any of our pending patent applications will result in additional issued patents;

 

   

there is no guarantee that any patents issued to us or our collaborative customers will provide a basis for commercially viable products;

 

   

there is no guarantee that any patents issued to us or our collaborative customers will provide us with any competitive advantages;

 

   

there is no guarantee that any patents issued to us or our collaborative customers will not be challenged or circumvented or invalidated by third parties; and

 

   

there is no guarantee that any patents issued to others will not have an adverse effect on our ability to do business.

The issuance of a patent is not conclusive as to its validity or enforceability, nor does it provide the patent holder with freedom to operate without infringing the patent rights of others. A patent could be challenged by litigation and, if the outcome of such litigation were adverse to the patent holder, competitors could be free to use the subject matter covered by the patent. The invalidation of key patents owned by or licensed to us or the non-approval of pending patent applications could increase competition and materially adversely affect our business, financial condition, and results of operations.

Litigation, which could result in substantial cost to us, also may be necessary to enforce our patent and proprietary rights and/or to determine the scope and validity of others’ proprietary rights. We may participate in interference proceedings that may in the future be declared by the USPTO to determine priority of invention, which could result in substantial cost to us. The outcome of any such litigation or interference proceeding might not be favorable to us, and we might not be able to obtain licenses to technology that we require or, even if obtainable, such technology may not be available at a reasonable cost.

 

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If we infringe on the intellectual property rights of others, we may be required to obtain a license, pay damages, and/or cease the commercialization of our technology.

We believe that there may be significant litigation in the industry regarding patent and other intellectual property rights. It is possible that the commercialization of our technology could infringe the patents or other intellectual property rights of others. In addition, others may have filed, and in the future are likely to file, patent applications covering genes or gene products or antibodies against the gene products that are similar or identical to our products. Any such patent applications may have priority over our patent applications, and may result in the issuance of patents to others that could be infringed by our products or processes.

A number of competitors are producing proteins from genes and claiming both the proteins as potential therapeutics as well as the antibodies against these proteins. In many cases, generic antibody claims are being issued by the USPTO even though competitors have not actually made antibodies against the protein of interest, or do not have cellular, animal, or human data to support the use of these antibodies as therapeutics. These claims to proteins as therapeutics, to all antibodies against a protein, and to methods of use in broad human indications are being filed at a rapid rate, and patents including such claims have issued and may continue to issue. Such patents may prevent us from commercializing some products or processes or, if licenses under the patents are made available, may make the royalty burden on these products and processes so high as to prevent commercial success.

In addition, we have sought and intend to continue to seek patent protection for novel uses for genes and proteins and therapeutic antibodies that may have been patented by third parties. In such cases, we would need a license from the holder of the patent with respect to such gene or protein in order to make, use, or sell such gene or protein for such use. We may not be able to acquire such licenses on commercially reasonable terms, if at all.

Certain third parties have indicated to us that they believe we may be required to obtain a license in order to perform certain processes that we use in the conduct of our business or in order to market potential drugs we have in development.

Any legal action against us or our collaborators for patent infringement relating to our products and processes could, in addition to subjecting us to potential liability for damages, require us or our collaborators to obtain a license in order to continue to manufacture or market the affected products and processes, or could enjoin us from continuing to manufacture or market the affected products and processes. There can be no assurance that we or our collaborators would prevail in any such action or that any license required under any such patent would be made available on commercially acceptable terms, if at all. If we become involved in such litigation, it could consume a substantial portion of our managerial and financial resources.

We cannot be certain that our security measures will protect our confidential information and proprietary technologies.

We rely upon trade secret protection for some of our confidential and proprietary information that is not the subject matter for which patent protection is being sought. We have taken security measures to protect our proprietary technologies, processes, information systems, and data and continue to explore ways to enhance such security. Such measures, however, may not provide adequate protection for our trade secrets or other proprietary information. While we require employees, academic collaborators, consultants, and scientific advisors to enter into confidentiality and/or non-disclosure agreements where appropriate, any of the following could still occur:

 

   

proprietary information could be disclosed;

 

   

others may independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets, technology, or disclose such information; or

 

   

we may not be able to meaningfully protect our trade secrets.

If the security of our confidential information is breached, our business could be materially adversely affected.

We depend upon our ability to license technologies.

We may have to acquire or license certain components of our technologies or products from third parties. We may not be able to acquire from third parties or develop new technologies, either alone or with others. We may not be able to acquire licenses on commercially reasonable terms, if at all. Failure to license or otherwise acquire necessary technologies could materially adversely affect our business, financial condition, and results of operations.

 

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If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected.

Our research and development efforts involve the controlled use of hazardous materials, chemicals and various radioactive compounds. Although we believe that our safety procedures for handling and disposing of these materials comply with the standards prescribed by state and federal regulations, the risk of accidental contamination or injury from these materials cannot be eliminated. If an accident occurs, we could be held liable for resulting damages, which could be substantial. We are also subject to numerous environmental, health and workplace safety laws and regulations, including those governing laboratory procedures, exposure to blood-borne pathogens and the handling of biohazardous materials. Although we maintain workers’ compensation insurance to cover us for costs we may incur due to injuries to our employees resulting from the use of these materials, this insurance may not provide adequate coverage against potential liabilities. Due to the small amount of hazardous materials that we generate, we do not currently maintain any environmental liability or toxic tort claim insurance coverage to cover pollution conditions or other extraordinary or unanticipated events relating to our use and disposal of hazardous materials. Additional federal, state and local laws and regulations affecting our operations may be adopted in the future. We may incur substantial costs to comply with, and substantial fines or penalties if we violate, any of these laws or regulations.

Risks Related to Our Financial Results

We have a large amount of debt and our debt service obligations may prevent us from taking actions that we would otherwise consider to be in our best interests.

As of June 30, 2007, we had total consolidated debt of $110.0 million which is due in February 2011; and for the year ended December 31, 2006, we had a deficiency of earnings available to cover fixed charges of $61.3 million. A variety of uncertainties and contingencies will affect our future performance, many of which are beyond our control. We may not generate sufficient cash flow in the future to enable us to meet our anticipated fixed charges, including our debt service requirements with respect to our debt that we sold in 2004. The following table shows, as of June 30, 2007, the remaining aggregate amount of our interest payments due in each of the years listed (in millions):

 

Year

  

Aggregate

Interest

2007

   $ 2.2

2008

     4.4

2009

     4.4

2010

     4.4

2011

     2.2
      

Total

   $ 17.6
      

Our substantial leverage could have significant negative consequences for our future operations, including:

 

   

increasing our vulnerability to general adverse economic and industry conditions;

 

   

limiting our ability to obtain additional financing;

 

   

requiring the dedication of a substantial portion of our expected cash flow to service our indebtedness, thereby reducing the amount of our expected cash flow available for other purposes, including working capital and capital expenditures;

 

   

limiting our flexibility in planning for, or reacting to, changes in our business and the industry in which we compete; or

 

   

placing us at a possible competitive disadvantage compared to less leveraged competitors and competitors that have better access to capital resources.

 

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We will likely need to raise additional funding, which may not be available on favorable terms, if at all.

We believe that we have sufficient capital to satisfy our funding requirements for the next 24 months. However, our future funding requirements will depend on many factors and we anticipate that we will likely need to raise additional capital to fund our business plan and research and development efforts on a going-forward basis. To the extent that we need to obtain additional funding, the amount of additional capital we would need to raise would depend on many factors, including:

 

   

the number, breadth, and progress of our research, product development, and clinical programs;

 

   

our ability to establish and maintain additional collaborations;

 

   

the progress of our collaborators;

 

   

our costs incurred in enforcing and defending our patent claims and other intellectual property rights; and

 

   

the costs and timing of obtaining regulatory approvals for any of our products; and

 

   

the extent to which RDO makes successful claims for indemnification under the Merger Agreement relating to the sale of 454.

We expect that we would raise any additional capital we require through public or private equity offerings, debt financings, or additional collaborations and licensing arrangements. We cannot be certain that in the future these sources of liquidity will be available when needed or that our actual cash requirements will not be greater than anticipated. In appropriate strategic situations, we may seek financial assistance from other sources, including contributions by others to joint ventures and other collaborative or licensing arrangements for the development and testing of products under development. If we raise additional capital by issuing equity securities, the issuance of such securities would result in ownership dilution to our stockholders. If we raise additional funds through collaborations and licensing arrangements, we may be required to relinquish rights to certain of our technologies or product candidates, or to grant licenses on unfavorable terms. The relinquishing of rights or granting of licenses on unfavorable terms could materially adversely affect our business, financial condition, and results of operations. If adequate funds are not available, our business, financial condition, and results of operations would be materially adversely affected. However, should we be unable to obtain future financing either through the methods described above or through other means, we may be unable to meet the critical objective of our long-term business plan, which is to successfully develop and market pharmaceutical products. If we require additional capital at a time when investment in biotechnology companies such as ours, or in the marketplace in general, is limited due to the then prevailing market or other conditions, we may not be able to raise such funds at the time that we desire or any time thereafter.

If the proceeds we receive from the sale of our stake in 454 are less than anticipated due to indemnification claims against the escrow account, our liquidity may be impaired, and we may be forced to seek alternative sources of financing sooner than anticipated.

We expect to use the proceeds we receive from the sale of our stake in 454 to make further investments in our clinical drug pipeline; however, as described in Note 4 to our condensed financial statements included in this Quarterly Report on Form 10-Q, $25 million of the total sale proceeds to 454 stockholders has been placed in an escrow account in order to secure certain indemnification rights of RDO and its affiliates. Our portion of the $25 million escrow fund totals $14.1 million. Under the Merger Agreement, Roche is entitled to indemnification for damages incurred by RDO, 454 and certain other RDO affiliates as a result of the following: breaches of representations, warranties or covenants made by 454 in the Merger Agreement; any payments by Roche or 454 to 454 stockholders who have made successful demands under Delaware law for appraisal, or payment of the fair value of their 454 shares as determined by the Delaware Court of Chancery, in excess of the sale proceeds which would otherwise have been payable to such stockholders pursuant to the merger agreement; costs incurred by the indemnified parties in connection with appraisal proceedings and compliance with certain environmental laws; and costs incurred by the indemnified parties in connection with the sale of 454 that were not previously taken into account in determining the price paid by RDO for 454. If RDO makes a successful claim for indemnification due to one or more of these reasons, the amount of the escrow account that is available for distribution to us and other 454 stockholders at the end of the 15-month escrow period will be reduced or eliminated.

 

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Our quarterly operating results have fluctuated greatly and may continue to do so.

Our operating results have fluctuated on a quarterly basis. We expect that losses will continue to fluctuate from quarter to quarter and that these fluctuations may be substantial. Our results of operations are difficult to predict and may fluctuate significantly from period to period, which may cause our stock price to decline and result in losses to investors. Some of the factors that could cause our operating results to fluctuate include:

 

   

the nature, pricing, and timing of products and services provided to our collaborators and customers;

 

   

our ability to compete effectively in our therapeutic discovery and development efforts against competitors that have greater financial or other resources or drug candidates that are in further stages of development;

 

   

acquisition, licensing, and other costs related to the expansion of our operations;

 

   

losses and expenses related to our investments;

 

   

regulatory developments;

 

   

regulatory actions and changes related to the development of drugs;

 

   

changes in intellectual property laws that affect our patent rights;

 

   

payments of milestones, license fees, or research payments under the terms of our external alliances and collaborations and our ability to monitor and enforce such payments; and

 

   

the timing of intellectual property licenses that we may enter.

We believe that quarterly comparisons of our financial results are not necessarily meaningful and should not be relied upon as an indication of future performance. In addition, fluctuations in quarterly results could affect the market price of our common stock in a manner unrelated to our long-term operating performance.

Our debt investments are impacted by the financial viability of the underlying companies.

We have a diversified portfolio of investments of which $22.3 million at June 30, 2007 were invested in U.S. Treasuries and debt investments that are sponsored by the U.S. Government. Our corporate fixed-rate debt investments comply with our policy of investing in only investment-grade debt instruments. The ability for the debt to be repaid upon maturity or to have a viable resale market is dependent, in part, on the financial success of the underlying company. Should the underlying company suffer significant financial difficulty, the debt instrument could either be downgraded or, in the worst case, our investment could be worthless. This would result in our losing the cash value of the investment and incurring a charge to our statement of operations.

The market price of our common stock is highly volatile.

The market price of our common stock has fluctuated widely and may continue to do so. For example, during the first six months of 2007, the sale price of our stock ranged from a high of $4.80 per share to a low of $1.97 per share. Many factors could cause the market price of our common stock to rise and fall. These factors include:

 

   

variations in our quarterly operating results;

 

   

announcements of technological innovations, clinical results, or new products by us or our competitors;

 

   

introduction of new products or new pricing policies by us or our competitors;

 

   

acquisitions or strategic alliances by us or others in our industry;

 

   

announcement by the government or other agencies regarding the economic health of the United States and the rest of the world;

 

   

the hiring or departure of key personnel;

 

   

changes in market valuations of companies within the biotechnology industry; and

 

   

changes in estimates of our performance or recommendations by financial analysts.

We have significant leverage as a result of the sales of our debt in 2004.

In February 2004, in connection with the sale of our 4% convertible subordinated notes due 2011, we incurred $100.0 million of indebtedness. In addition, in March 2004, the initial purchasers exercised their option to purchase an additional $10.0 million of 4% convertible subordinated notes due in 2011. As a result of this indebtedness of $110.0 million, our interest payment obligations amount to $4.4 million per year.

The degree to which we are leveraged could adversely affect our ability to obtain further financing for working capital, acquisitions, or other purposes and could make us more vulnerable to industry downturns and competitive pressures. Our ability to meet our debt service obligations will depend upon our future performance, which may be subject to the financial, business, and other factors affecting our operations, many of which are beyond our control.

 

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There are no restrictive covenants in our indentures relating to our ability to incur future indebtedness.

The indentures governing our convertible debt due in 2011 do not contain any financial or operating covenants or restrictions on the payment of dividends, the incurrence of indebtedness, transactions with affiliates, incurrence of liens, or the issuance or repurchase of securities by us or any of our subsidiaries. We may therefore incur additional debt, including secured indebtedness senior to these notes.

Our debt service obligations may adversely affect our cash flow.

A higher level of indebtedness increases the risk that we may default on our debt obligations. We cannot be certain that we will be able to generate sufficient cash flow to pay the interest on our debt or that future working capital, borrowings, or equity financing will be available to pay or refinance such debt. If we are unable to generate sufficient cash flow to pay the interest on our debt, we may have to delay or curtail our research and development programs. The level of our indebtedness among other things, could:

 

   

make it difficult for us to make payments on our notes;

 

   

make it difficult for us to obtain any necessary financing in the future for working capital, capital expenditures, debt service requirements, or other purposes;

 

   

limit our flexibility in planning for, or reacting to, changes in our business and the industry in which we compete; and

 

   

make us more vulnerable in the event of a downturn in our business.

Our ability to repurchase notes, if required, with cash upon a change in control or fundamental change may be limited.

In certain circumstances involving a change of control or fundamental change, we may be required to repurchase some or all of the notes due 2011. We cannot be certain that we will have sufficient financial resources at such time or would be able to arrange financing to pay the repurchase price of the notes. Our ability to repurchase the notes in such event may be limited by law, by the indenture, and by such indebtedness and agreements as may be entered into, replaced, supplemented, or amended from time to time.

Securities we issue to fund our operations could cause dilution to our stockholders’ ownership.

We may decide to raise additional funds through a public or private debt or equity financing to fund our operations. If we raise funds by issuing equity securities, the percentage ownership of current stockholders will be reduced, and the new equity securities may have rights with priority over our common stock. We may not be able to obtain sufficient financing on terms that are favorable to us or our existing stockholders, if at all.

Any conversion of our convertible debt into shares of common stock will dilute the ownership interest of our current stockholders. The conversion price of our convertible debt due in February 2011 is approximately $9.69 per share.

 

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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

The following information relates to all securities of CuraGen sold by us within the past quarter which were not registered under the securities laws at the time of grant, issuance and/or sale:

Restricted Stock Awards

On May 25, 2007, pursuant to our 2007 Stock Incentive Plan, we awarded an aggregate of 975,000 shares of restricted common stock to five executive officers, which shares were not registered under the Securities Act of 1933, as amended (the “Securities Act”). The executives did not pay us any cash consideration for the shares.

We did not employ an underwriter in connection with the issuance of the securities described above. The sale and issuance of the securities described above were deemed to be exempt from registration under the Securities Act in reliance on the exemption provided by Section 4(2) of the Securities Act as transactions by an issuer not involving a public offering. All recipients had adequate access to information about us.

Item 4. Submission of Matters to a Vote of Security Holders

Our Annual Meeting of Stockholders was held on May 2, 2007.

There were present at the Annual Meeting, in person or by proxy, stockholders holding an aggregate of 56,918,094 shares of common stock. The results of the vote taken at the Annual Meeting with respect to the election of the nominees to serve as Class III directors were as follows:

 

Class III Director Nominees

 

For

 

Withheld

David R. Ebsworth, Ph.D.   40,342,207 shares   11,355,952 shares
Patrick J. Zenner   31,390,674 shares   20,307,485 shares

Messrs. Ebsworth and Zenner were each elected to serve for a three-year term of office or until their successors are duly elected and qualified. John H. Forsgren, James J. Noble and Robert E. Patricelli are currently serving as Class I Directors and Frank M. Armstrong and Vincent T. DeVita, Jr. are currently serving as Class II Directors.

In addition, a vote of the stockholders was taken at the Annual Meeting with respect to the proposal to approve the Company’s 2007 Stock Incentive Plan. Of the 56,918,094 shares of common stock present at the Annual Meeting, 24,371,209 shares voted in favor of such proposal, 11,587,001 shares were voted against such proposal and 50,255 shares abstained from voting.

Item 5. Other Information

On August 6, 2007, the Company presented an update on the Company’s clinical programs including the items listed below. In addition, the Company reiterated its 2007 financial guidance previously provided on July 26, 2007 and provided preliminary estimates for use of cash and investments to fund continuing operations during 2008.

Velafermin for the prevention of severe oral mucositis (OM):

Enrollment has been completed in the Phase II randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of a single infusion of velafermin for the prevention of severe OM. A total of 390 patients at 33 centers were enrolled throughout the United States. Primary safety and efficacy assessments of treated patients will be concluded at participating centers during August with preliminary, top-line efficacy results from the completed trial available in mid-October of 2007. Patients will be followed for an additional year to assess long term outcome with results available during the fourth quarter of 2008. The Phase II trial is designed to assess the reduction in the incidence of severe WHO Grade 3 or 4 OM in patients receiving high-dose chemotherapy, with or without total body irradiation (TBI), prior to autologous bone marrow transplantation (BMT). Patients enrolled in the trial were randomized to receive a single infusion of either placebo or one of three doses of velafermin (10 mcg/kg, 30 mcg/kg or 60 mcg/kg) administered 24 hours after BMT.

 

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Belinostat in combination with Velcade® (bortezomib) for Injection against Multiple Myeloma (MM):

In the Phase II open-label clinical trial evaluating intravenous belinostat in combination with Velcade® (bortezomib) for Injection in patients with advanced, refractory MM, two out of four patients enrolled developed acute deterioration in already existing renal insufficiency (ARI) in the first cycle of combination treatment. ARI is a common complication in the treatment of MM patients due to deposition of myeloma protein in the kidney. Three similar events were seen in previously conducted single agent studies with belinostat in patients with MM. No ARI has been observed in any other indication for which intravenous or oral belinostat is being evaluated.

An ongoing Phase I NCI-sponsored clinical trial evaluating intravenous belinostat plus Velcade® (bortezomib) for Injection against solid tumors and lymphoma remains open for enrollment and is continuing to treat patients with the combination. This trial is being conducted under a Clinical Trials Agreement between the NCI and CuraGen.

Belinostat in combination with carboplatin and paclitaxel against ovarian cancer:

To date, three partial responses (two confirmed, one unconfirmed) have been achieved in the 23 heavily pretreated patients with recurrent ovarian cancer enrolled, of which 14 patients remain on study with best response yet to be determined. The response rate observed in Stage I of the study design has triggered expansion of enrollment to a total of 32 patients in this Phase II Simon-Two stage design clinical trial in order to gain a better estimate of the objective response rate and duration of response. CuraGen anticipates presenting updated results during the fourth quarter of 2007.

Belinostat in combination with carboplatin and paclitaxel against bladder cancer:

Patient treatment was recently initiated in this Phase II open-label trial. A total of 15 patients with transitional cell cancer of the bladder will be enrolled to evaluate the safety and efficacy of intravenous belinostat in combination with carboplatin and paclitaxel.

Belinostat in combination with idarubicin against Acute Myelogenous Leukemia (AML):

A Phase I/II clinical trial evaluating belinostat in combination with the idarubicin for the treatment of AML is being initiated at multiple sites in the EU. Patients under the age of 60 with relapsed or refractory AML, or patients over 60 with newly diagnosed or previously treated AML, are eligible for enrollment in the trial. Up to 70 patients will be enrolled and receive intravenous treatment in one of two regimens. Patients will either receive intravenous belinostat administered once daily for five days in combination with idarubicin or a continuous infusion of belinostat with or without idarubicin. Enrollment into the treatment arms will occur in parallel to define the maximum tolerated dose (MTD) for each treatment regimen.

CR011-vcMMAE Phase I/II trial for the treatment of metastatic melanoma:

Enrollment in the Phase I dose-escalation trial to determine the maximum tolerated dose (MTD) of CR011-vcMMAE in patients with unresectable Stage III or IV metastatic melanoma is ongoing. Upon establishment of the MTD, the trial will be advanced into Phase II to further define the safety and efficacy of CR011-vcMMAE. CuraGen anticipates presenting Phase I dose-escalation results in the fourth quarter of 2007.

 

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Item 6. Exhibits

 

Exhibit 10.1   2007 Stock Incentive Plan of the Registrant
Exhibit 10.2   Form of Non-Qualified Stock Option Agreement of the Registrant under the 2007 Stock Incentive Plan
Exhibit 10.3   Form of Incentive Stock Option Agreement of the Registrant under the 2007 Stock Incentive Plan
Exhibit 10.4   Form of Restricted Stock Agreement (standard) under the 2007 Stock Incentive Plan
Exhibit 10.5   Form of Restricted Stock Agreement for restricted stock awards granted on May 25, 2007 to each of Frank M. Armstrong, Paul M. Finigan, Timothy M. Shannon, Elizabeth A. Whayland and David M. Wurzer under the 2007 Stock Incentive Plan
Exhibit 31.1   Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
Exhibit 31.2   Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
Exhibit 32   Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code).

 

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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.

 

Dated: August 9, 2007   CuraGen Corporation
  By:  

/s/ Frank M. Armstrong, M.D.

    Frank M. Armstrong, M.D.
    Chief Executive Officer and President
    (principal executive officer of the registrant)
Dated: August 9, 2007   By:  

/s/ David M. Wurzer

    David M. Wurzer
   

Executive Vice-President, Chief Financial Officer

and Treasurer (principal financial and accounting

officer of the registrant)

 

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CURAGEN CORPORATION

EXHIBIT INDEX

 

No.

         
   Exhibit 10.1    2007 Stock Incentive Plan of the Registrant
   Exhibit 10.2    Form of Non-Qualified Stock Option Agreement of the Registrant under the 2007 Stock Incentive Plan
   Exhibit 10.3    Form of Incentive Stock Option Agreement of the Registrant under the 2007 Stock Incentive Plan
   Exhibit 10.4    Form of Restricted Stock Agreement (standard) under the 2007 Stock Incentive Plan
   Exhibit 10.5    Form of Restricted Stock Agreement for restricted stock awards granted on May 25, 2007 to each of Frank M. Armstrong, Paul M. Finigan, Timothy M. Shannon, Elizabeth A. Whayland and David M. Wurzer under the 2007 Stock Incentive Plan
   Exhibit 31.1    Certification by Chief Executive Officer pursuant to Rule 13a-14(a) and 15d-14(a) of the Exchange Act, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
   Exhibit 31.2    Certification by Chief Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a) of the Exchange Act, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
   Exhibit 32    Certification by Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

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