e10vq
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FORM 10-Q
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
(Mark One)
     
þ   QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2007
OR
     
o   TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the Transition Period from                      to
Commission File Number 001-32157
 
ADVENTRX Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
     
Delaware   84-1318182
(State or other jurisdiction of incorporation or organization)   (I.R.S. Employer Identification No.)
     
6725 Mesa Ridge Road, Ste 100, San Diego, CA   92121
(Address of principal executive offices)   (Zip Code)
 
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes    þ       No    o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer    o       Accelerated filer    þ       Non-accelerated filer    o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes    o       No    þ
The number of shares outstanding of the registrant’s common stock, $.001 par value, as of May 4, 2007 was 89,706,739.
 
 

 


Table of Contents

TABLE OF CONTENTS
         
        Page
PART I      
   
 
   
Item 1.      
   
 
   
      3
   
 
   
      4
   
 
   
      5
   
 
   
      6
   
 
   
Item 2.     12
   
 
   
Item 3.     17
   
 
   
Item 4.     17
   
 
   
PART II      
   
 
   
Item 1.     18
   
 
   
Item 1A.     18
   
 
   
Item 2.     18
   
 
   
Item 3.     18
   
 
   
Item 4.     18
   
 
   
Item 5.     18
   
 
   
Item 6.     18
   
 
   
      19
 EXHIBIT 10.1
 EXHIBIT 10.2
 EXHIBIT 10.3
 EXHIBIT 31.1
 EXHIBIT 31.2
 EXHIBIT 32.1

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PART I — FINANCIAL INFORMATION
Item 1. Financial Statements
ADVENTRX Pharmaceuticals, Inc. and Subsidiaries
(A Development Stage Enterprise)
Condensed Consolidated Balance Sheets
                 
    March 31,     December 31,  
    2007     2006  
    (unaudited)     (Note 1)  
Assets
               
Current assets:
               
Cash and cash equivalents
  $ 20,954,573     $ 25,974,041  
Short-term investments
    26,485,512       25,771,406  
Interest receivable
    131,524       80,338  
Prepaid expenses
    612,286       511,327  
 
           
Total current assets
    48,183,895       52,337,112  
 
               
Property and equipment, net
    387,509       402,968  
Other assets
    58,305       58,305  
 
           
Total assets
  $ 48,629,709     $ 52,798,385  
 
           
 
               
Liabilities and Stockholders’ Equity
               
Current liabilities:
               
Accounts payable
  $ 98,596     $ 480,402  
Accrued liabilities
    1,906,948       1,675,226  
Accrued compensation and payroll taxes
    777,664       292,896  
 
           
Total current liabilities
    2,783,208       2,448,524  
Long-term liabilities
    30,323       35,674  
 
           
Total liabilities
    2,813,531       2,484,198  
 
           
 
               
Commitments and contingencies
               
 
               
Stockholders’ equity:
               
Preferred stock; 1,000,000 shares authorized; no shares issued or outstanding
           
Common stock, $0.001 par value; 200,000,000 shares authorized; 89,676,739 shares issued and outstanding
    89,678       89,678  
Additional paid-in capital
    127,909,082       127,283,524  
Deficit accumulated during the development stage
    (82,180,739 )     (77,056,925 )
Accumulated other comprehensive loss
    (1,843 )     (2,090 )
 
           
Total stockholders’ equity
    45,816,178       50,314,187  
 
           
Total liabilities and stockholders’ equity
  $ 48,629,709     $ 52,798,385  
 
           
See accompanying notes to unaudited condensed consolidated financial statements.

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ADVENTRX Pharmaceuticals, Inc. and Subsidiaries
(A Development Stage Enterprise)
Condensed Consolidated Statements of Operations
(unaudited)
                         
                    Inception  
                    (June 12, 1996)  
                    through  
    Three months ended March 31,     March 31,  
    2007     2006     2007  
            (Note 1)     (Note 1)  
Revenues:
                       
Net sales
  $     $     $ 174,830  
Cost of goods sold
                51,094  
 
                 
Gross margin
                123,736  
Grant revenue
                129,733  
Licensing revenue
    500,000             500,000  
 
                 
Total revenues
    500,000             753,469  
 
                 
 
                       
Operating expenses:
                       
Research and development
    3,384,660       2,483,858       31,542,624  
Selling, general and administrative
    2,809,449       1,735,172       27,380,185  
Depreciation and amortization
    51,889       37,113       10,484,138  
In-process research and development
                10,422,130  
Impairment loss — write off of goodwill
                5,702,130  
Equity in loss of investee
                178,936  
 
                 
Total operating expenses
    6,245,998       4,256,143       85,710,143  
 
                 
 
                       
Loss from operations
    (5,745,998 )     (4,256,143 )     (84,956,674 )
Interest income
    622,184       236,527       2,485,243  
Interest expense
                (179,090 )
 
                 
Loss before cumulative effect of change in accounting principle
    (5,123,814 )     (4,019,616 )     (82,650,521 )
 
                       
Cumulative effect of change in accounting principle
                (25,821 )
 
                 
Net loss
    (5,123,814 )     (4,019,616 )     (82,676,342 )
 
                       
Preferred stock dividends
                (621,240 )
 
                 
Net loss applicable to common stock
  $ (5,123,814 )   $ (4,019,616 )   $ (83,297,582 )
 
                 
 
                       
Loss per common share — basic and diluted
  $ (0.06 )   $ (0.06 )        
 
                   
 
                       
Weighted average shares outstanding — basic and diluted
    89,676,739       67,976,352          
 
                   
See accompanying notes to unaudited condensed consolidated financial statements.

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ADVENTRX Pharmaceuticals, Inc. and Subsidiaries
(A Development Stage Enterprise)
Condensed Consolidated Statements of Cash Flows
(unaudited)
                         
                    Inception  
                    (June 12, 1996)  
                    through  
    Three months ended March 31,     March 31,  
    2007     2006     2007  
            (Note 1)     (Note 1)  
Cash flows from operating activities:
                       
Net loss
  $ (5,123,814 )   $ (4,019,616 )   $ (82,676,342 )
Adjustments to reconcile net loss to net cash used in operating activities:
                       
Depreciation and amortization
    51,889       37,113       10,034,138  
In-process research and development
                10,422,130  
Share-based compensation for employee awards
    600,009       444,655       4,432,586  
Expense related to stock options issued to non-employees
    25,549       94,346       223,323  
Expenses paid by issuance of common stock
    19,583       88,920       1,282,622  
Expenses paid by issuance of warrants
                573,357  
Expenses paid by issuance of preferred stock
                142,501  
Expenses related to stock warrants issued
                612,000  
Accretion of discount on investments in securities
    (282,792 )     (68,209 )     (637,433 )
Amortization of debt discount
                450,000  
Forgiveness of employee receivable
                30,036  
Impairment loss — write-off of goodwill
                5,702,130  
Equity in loss of investee
                178,936  
Write-off of license agreement
                152,866  
Write-off of assets available for sale
                108,000  
Cumulative effect of change in accounting principle
                25,821  
Changes in assets and liabilities, net of effect of acquisitions:
                       
Increase in prepaid and other assets
    (171,728 )     (77,976 )     (990,734 )
Increase in accounts payable and accrued liabilities
    334,684       511,533       2,959,915  
Increase (decrease) in other long-term liabilities
    (5,351 )           30,323  
 
                 
Net cash used in operating activities
    (4,551,971 )     (2,989,234 )     (46,943,825 )
 
                 
Cash flows from investing activities:
                       
Purchases of short-term investments
    (13,681,067 )     (3,874,000 )     (59,404,698 )
Proceeds from sales and maturities of short-term investments
    13,250,000       6,705,000       33,554,776  
Purchases of property and equipment
    (36,430 )     (18,671 )     (874,569 )
Purchase of certificate of deposit
                (1,016,330 )
Maturity of certificate of deposit
                1,016,330  
Payment on obligation under license agreement
                (106,250 )
Cash acquired from acquisitions, net of cash paid
                32,395  
Issuance of note receivable — related party
                (35,000 )
Payments on note receivable
                405,993  
Advance to investee
                (90,475 )
Cash transferred in rescission of acquisition
                (19,475 )
Cash received in rescission of acquisition
                230,000  
 
                 
Net cash provided by (used in) investing activities
    (467,497 )     2,812,329       (26,307,303 )
 
                 
Cash flows from financing activities:
                       
Proceeds from sale of preferred stock
                4,200,993  
Proceeds from sale of common stock
                84,151,342  
Proceeds from exercise of stock options
                270,751  
Proceeds from sale or exercise of warrants
          2,425,200       11,382,894  
Repurchase of warrants
                (55,279 )
Payment of financing and offering costs
          (63,620 )     (6,483,809 )
Payments of notes payable and long-term debt
                (605,909 )
Proceeds from issuance of notes payable and detachable warrants
                1,344,718  
 
                 
Net cash provided by financing activities
          2,361,580       94,205,701  
 
                 
Net increase (decrease) in cash and cash equivalents
    (5,019,468 )     2,184,675       20,954,573  
Cash and cash equivalents at beginning of period
    25,974,041       14,634,618        
 
                 
Cash and cash equivalents at end of period
  $ 20,954,573     $ 16,819,293     $ 20,954,573  
 
                 
See accompanying notes to unaudited condensed consolidated financial statements.

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ADVENTRX Pharmaceuticals, Inc. and Subsidiaries
(A Development Stage Enterprise)
Notes to Condensed Consolidated Financial Statements (Unaudited)
1.   Summary of Significant Accounting Policies
 
    Basis of Presentation. ADVENTRX Pharmaceuticals, Inc., a Delaware corporation (“ADVENTRX,” “we” or the “Company”) prepared the unaudited interim condensed consolidated financial statements in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions of the Securities and Exchange Commission (“SEC”). Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for annual audited financial statements and should be read in conjunction with the Company’s audited consolidated financial statements and related notes for the year ended December 31, 2006 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 15, 2006 (“2006 Annual Report”). The condensed consolidated balance sheet as of December 31, 2006 has been derived from the audited consolidated financial statements included in the 2006 Annual Report. In the opinion of management, these consolidated financial statements include all adjustments (consisting of normal recurring adjustments) necessary for a fair presentation of the financial position, results of operations, and cash flows for the periods presented. The results of operations for the interim periods shown in this report are not necessarily indicative of results expected for the full year. Certain amounts in the prior periods have been reclassified to conform to the current year presentation.
 
    Since our inception, we have reported accumulated net losses of approximately $82.7 million and recurring negative cash flows from operations. In order to maintain sufficient cash and investments to fund future operations, we anticipate raising additional capital in the next 12 months through various financing alternatives including licensing or selling our technologies or through the sale of our common stock. The balance of securities available for sale under our existing shelf registration was approximately $60.0 million as of March 31, 2007. We believe our cash, cash equivalents and investments in securities of approximately $47.4 million as of March 31, 2007 will be sufficient to sustain our planned level of operations for at least the next 12 months.
 
    Principles of Consolidation. The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, SD Pharmaceuticals, Inc. and ADVENTRX (Europe) Ltd. All intercompany accounts and transactions have been eliminated in consolidation. Certain amounts in the prior year consolidated financial statements have been reclassified to conform to the current year presentation.
 
    Management Estimates. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts and the disclosure of contingent amounts in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates.
 
    Change in Accounting Principle for Registration Payment Arrangements. In December 2006, the Financial Accounting Standards Board (“FASB”) issued FASB Staff Position on No. EITF 00-19-2, Accounting for Registration Payment Arrangements (“FSP EITF 00-19-2”). FSP EITF 00-19-2 provides that the contingent obligation to make future payments or otherwise transfer consideration under a registration payment arrangement should be separately recognized and measured in accordance with Statement of Financial Accounting Standards (“FAS”) No. 5, Accounting for Contingencies, which provides that loss contingencies should be recognized as liabilities if they are probable and reasonably estimable. Subsequent to the adoption of FSP EITF 00-19-2, any changes in the carrying amount of the contingent liability will result in a gain or loss that will be recognized in the consolidated statement of operations in the period the changes occur. The guidance in FSP EITF 00-19-2 is effective immediately for registration payment arrangements and the financial instruments subject to those arrangements that are entered into or modified subsequent to the date of issuance of FSP EITF 00-19-2. For registration payment arrangements and financial instruments subject to those arrangements that were entered into prior to the issuance of FSP EITF 00-19-2, this guidance is effective for our consolidated financial statements issued for the year beginning January 1, 2007, and interim periods within that year.
 
    On January 1, 2007, we adopted the provisions of FSP EITF 00-19-2 to account for the registration payment arrangement associated with our July 2005 financing (the “July 2005 Registration Payment Arrangement”). As of January 1, 2007 and March 31, 2007, management determined that it was not probable that we would have any payment obligation under the July 2005 Registration Payment Arrangement; therefore, no accrual for contingent obligation is required under the provisions of FSP EITF 00-19-2. Accordingly, the warrant liability account was eliminated and the comparative condensed consolidated financial statements of prior periods and as of December 31, 2006 have been adjusted to apply the new method retrospectively. The

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    following financial statement line items for the three months ended March 31, 2007 and 2006 were affected by the change in accounting principle:
Consolidated Statements of Operations
                         
    As Computed   As Reported    
    under   under FSP   Effect of
    EITF 00-19   EITF 00-19-2   Change
Three Months Ended March 31, 2007
                       
Loss from operations
  $ (5,745,998 )   $ (5,745,998 )   $  
Gain on fair value of warrants
    4,842,930             (4,842,930 )
Net loss
    (280,884 )     (5,123,814 )     (4,842,930 )
Net loss per share
  $     $ (0.06 )   $ (0.06 )
 
                       
Inception (June 12, 1996) Through March 31, 2007
                       
Loss from operations
  $ (84,956,674 )   $ (84,956,674 )   $  
Loss on fair value of warrants
    (7,396,758 )           7,396,758  
Net loss
    (90,073,100 )     (82,676,342 )     7,396,758  
Net loss applicable to common stock
    (90,694,340 )     (83,297,582 )     7,396,758  
                         
    As Originally           Effect of
    Reported   As Adjusted   Change
Three Months Ended March 31, 2006
                       
Loss from operations
  $ (4,256,143 )   $ (4,256,143 )   $  
Loss on fair value warrants
    (17,027,065 )           17,027,065  
Net loss
    (21,046,681 )     (4,019,616 )     17,027,065  
Net loss per share
  $ (0.31 )   $ (0.06 )   $ 0.25  
 
                       
Inception (June 12, 1996)Through March 31, 2006
                       
Loss from operations
  $ (53,630,352 )   $ (53,630,352 )   $  
Loss on fair value warrants
    (28,606,725 )           28,606,725  
Net loss
    (81,507,124 )     (52,900,399 )     28,606,725  
Net loss applicable to common stock
    (82,128,364 )     (53,521,639 )     28,606,725  
Consolidated Balance Sheet
                         
    As Computed   As Reported    
    under   under FSP   Effect of
    EITF 00-19   EITF 00-19-2   Change
March 31, 2007
                       
Warrant liability
  $ 25,513,509     $     $ (25,513,509 )
Total liabilities
    28,327,040       2,813,531       (25,513,509 )
Additional paid-in capital
    109,792,331       127,909,082       18,116,751  
Deficit accumulated during the development stage
    (89,577,497 )     (82,180,739 )     7,396,758  
Total stockholders’ equity
    20,302,669       45,816,178       25,513,509  
                         
    As Originally           Effect of
    Reported   As Adjusted   Change
December 31, 2006
                       
Warrant liability
  $ 30,356,439     $     $ (30,356,439 )
Total liabilities
    32,840,637       2,484,198       (30,356,439 )
Additional paid-in capital
    109,166,773       127,283,524       18,116,751  
Deficit accumulated during the development stage
    (89,296,613 )     (77,056,925 )     12,239,688  
Total stockholders’ equity
    19,957,748       50,314,187       30,356,439  

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As a result of the accounting change, the cumulative effect of the change on our consolidated stockholders’ equity as of January 1, 2006 is as follows:
                         
    As Originally           Effect of
    Reported   As Adjusted   Change
January 1, 2006
                       
Additional paid-in capital
  $ 52,105,329     $ 70,222,080     $ 18,116,751  
Deficit accumulated during the development stage
    (59,964,840 )     (48,385,180 )     11,579,660  
Total stockholders’ equity (deficit)
    (7,828,616 )     21,867,795       29,696,411  
Consolidated Statements of Cash Flows
                         
    As Computed   As Reported    
    under   under FSP   Effect of
    EITF 00-19   EITF 00-19-2   Change
March 31, 2007
                       
Net loss
  $ (280,884 )   $ (5,123,814 )   $ (4,842,930 )
Gain on value of warrant liability
    (4,842,930 )           4,842,930  
 
                       
Inception (June 12, 1996) through March 31, 2007
                       
Net loss
  $ (90,073,100 )   $ (82,676,342 )   $ 7,396,758  
Loss on value of warrant liability
    7,396,758             (7,396,758 )
                         
    As Originally           Effect of
    Reported   As Adjusted   Change
March 31, 2006
                       
Net loss
  $ (21,046,681 )   $ (4,019,616 )   $ 17,027,065  
Loss on value of warrant liability
    17,027,065             (17,027,065 )
 
                       
Inception (June 12, 1996) through March 31, 2006
                       
Net loss
  $ (81,507,124 )   $ (52,900,399 )   $ 28,606,725  
Loss on value of warrant liability
    28,606,725             (28,606,725 )
Income Taxes. In July 2006, FASB issued FASB Interpretation No. 48, Accounting for Uncertainty in Income Taxes-an Interpretation of FASB Statement 109 (“FIN 48”), which clarifies the accounting for uncertainty in tax positions. FIN 48 provides that the tax effects from an uncertain tax position can be recognized in our consolidated financial statements only if the position is more likely than not of being sustained upon an examination by tax authorities. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained. Additionally, FIN 48 provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. The provisions of FIN 48 are effective for us as of January 1, 2007, with the cumulative effect of the change in accounting principle recorded as an adjustment to opening retained earnings in the year of adoption. We adopted FIN 48 on January 1, 2007, which did not have a material impact on our consolidated results of operations or financial position. See Note 4.
Computation of Net Loss per Common Share. We calculate basic and diluted net loss per common share in accordance with the FAS No. 128, Earnings Per Share. Basic net loss per common share was calculated by dividing the net loss for the period by the weighted-average number of common shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per common share was calculated by dividing the net loss for the period by the weighted-average number of common stock equivalents outstanding during the period. For purposes of this calculation, options and warrants are considered to be common stock equivalents and are only included in the calculation of diluted earnings per common share when their effect is dilutive. We have excluded the following options and warrants from the calculation of diluted net loss per common share for the three months ended March 31, 2007 and 2006 because their effect is anti-dilutive:
                 
    Three Months Ended March 31,
    2007   2006
Warrants
    13,458,549       17,737,100  
Options
    4,297,957       3,113,000  
 
               
 
    17,756,506       20,850,100  
 
               
Comprehensive Loss. Comprehensive loss is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources, including foreign currency translation adjustments and unrealized gains and losses on short-term investments. Our components of comprehensive loss consist of net loss and unrealized gains or losses on short-term investments in securities. For the three months ended March 31, 2007 and 2006 and the period from inception (June 12, 1996) through March 31, 2007, comprehensive loss was $5.1 million, $4.0 million and $82.7 million, respectively.

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Share-Based Payments. Estimated share-based compensation expense related to stock options granted to employees for the three months ended March 31, 2007 and 2006 was as follows:
                 
    Three Months Ended March 31,  
    2007     2006  
Selling, general and administrative expense
  $ 346,305     $ 311,195  
Research and development expense
    253,704       133,460  
 
           
Share-based compensation expense before taxes
    600,009       444,655  
Related income tax benefits
           
 
           
Share-based compensation expense
  $ 600,009     $ 444,655  
 
           
Net share-based compensation expense per common share — basic and diluted
  $ 0.01     $ 0.01  
 
           
Since we have a net operating loss carryforward as of March 31, 2007, no excess tax benefits for the tax deductions related to share-based awards were recognized in the condensed consolidated statement of operations. There were no employee stock options exercised in the three months ended March 31, 2007 and 2006.
At March 31, 2007, total unrecognized estimated compensation cost related to nonvested employee share-based awards granted prior to that date was $5.2 million, which is expected to be recognized over a weighted-average period of 3.5 years. During the three months ended March 31, 2007 and 2006, we granted 652,333 and 656,000 stock options, respectively, to our employees with the estimated weighted-average grant-date fair value of $2.51 and $3.35 per share, respectively. The assumptions used in the Black-Scholes option-valuation model to estimate the grant-date fair value for employee option grants during the three months ended March 31, 2007 and 2006 are as follows:
                 
    Three Months Ended March 31,
    2007   2006
Weighted expected volatility
    138.1 %     89.5 %
Expect term (in years)
    6.1       5.0  
Risk-free interest rate
    4.7 %     4.1% – 4.52 %
Dividend yield
    0       0  
Supplementary Cash Flow Information. Noncash investing and financing transactions excluded from the condensed consolidated statements of cash flows for the three months ended March 31, 2007 and 2006 and for the period from inception (June 12, 1996) through March 31, 2007 are as follows:
                         
                    Inception
                    (June 12, 1996)
    Three months ended March 31,   through
    2007   2006   March 31, 2007
Supplemental disclosures of cash flow information:
                       
Interest paid
  $     $     $ 179,090  
Income taxes paid
                 
 
                       
Issuance of warrants, common stock and preferred stock for:
                       
Conversion of notes payable and accrued interest
  $     $     $ 1,213,988  
Prepaid services to consultants
                1,482,781  
Conversion of preferred stock
                2,705  
Acquisitions
                24,781,555  
Payment of dividends
                213,000  
Financial advisor services in conjunction with private placement
                1,137,456  
Acquisition of treasury stock in settlement of a claim
                34,747  
Cancellation of treasury stock
                (34,747 )
Assumptions of liabilities in acquisitions
                1,235,907  
Acquisition of license agreement for long-term debt
                161,180  
Cashless exercise of warrants
          13       4,312  
Dividends accrued
                621,040  
Trade asset converted to available for sale asset
                108,000  
Dividends extinguished
                408,240  
Trade payable converted to note payable
                83,948  
Issuance of warrants for return of common stock
                50,852  
Detachable warrants issued with notes payable
                450,000  
Unrealized (gain) loss on short-term investments
    (247 )     964       1,843  

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    Recent Accounting Pronouncements. In February 2007, FASB issued FAS No. 159, The Fair Value Option for Financial Assets and Financial Liabilities (“FAS 159”), which gives companies the option to measure eligible financial assets, financial liabilities and firm commitments at fair value (i.e., the fair value option), on an instrument-by-instrument basis, that are otherwise not permitted to be accounted for at fair value under other accounting standards. The election to use the fair value option is available when an entity first recognizes a financial asset or liability or upon entering into a firm commitment. Subsequent changes in fair value must be recorded in earnings. FAS 159 is effective for financial statements issued for fiscal year beginning after November 15, 2007. We do not expect adoption of FAS 159 will have a material impact on our consolidated results of operations or financial position.
 
2.   Registration Payment Arrangement
 
    On July 21, 2005, we entered into a securities purchase agreement (the “Agreement”) with certain accredited institutional investors (the “Purchasers”) for the sale of 10,810,809 shares of our common stock (the “Shares”) at a purchase price of $1.85 per share for aggregate gross proceeds of $19,999,997. In connection with this financing, we issued the Purchasers seven-year warrants to purchase 10,810,809 shares of our common stock (the “Warrant Shares”) at an exercise price of $2.26 per share. We received net proceeds of $18,313,751, after deducting commissions and offering fees and expenses, which included cash payments of $1,403,000 to placement agents and $283,246 in legal and accounting fees.
 
    Pursuant to the terms of the Agreement, if (i) a registration statement covering (A) all of the Shares and the Warrant Shares and (B) any other shares of common stock issued or issuable in respect to the Shares and the Warrant Shares because of stock splits, stock dividends, reclassifications, recapitalizations or similar events (together, the “Registrable Shares”) required to be covered thereby and required to be filed by us is (A) not filed with the SEC on or before 45 days after the closing of such financing (a “Filing Failure”) or (B) if such registration statement is not declared effective by the SEC on or before 90 days after the closing of such financing (an “Effectiveness Failure”) or (ii) on any day after the effective date of the registration statement sales of all the Registrable Shares required to be included on such registration statement cannot be made (other than as permitted during a suspension pursuant to the Agreement) pursuant to such registration statement (including, without limitation, because of a failure to keep the registration statement effective, to disclose such information as is necessary for sales to be made pursuant to such registration statement or to register sufficient shares of Shares) (a “Maintenance Failure”), then, we will be obligated, without limiting any other remedies of any Purchaser, to pay as liquidated damages (the “Liquidated Damages”) for such failure and not as a penalty to any Purchaser an amount in cash determined in accordance with the formula set forth below:
    For each 30-day period that a Filing Failure, Effectiveness Failure or Maintenance Failure remains uncured, we will pay an amount equal to the purchase price paid to us for all Shares then held by such Purchaser multiplied by 1% for the first 30-day period or any portion thereof and increasing by an additional 1% with regard to each additional 30-day period until such Filing Failure, Effectiveness Failure or Maintenance Failure is cured.
 
    For any partial 30-day period in which a Filing Failure, Effectiveness Failure or Maintenance Failure exists but is cured prior to the end of the 30-day period, we will pay the Purchasers a pro rata portion of the amount which would be due if the failure continued for the entire 30-day period. For example, if the purchase price paid for all Shares then held by a Purchaser is $5,000,000, then, (a) at the end of the 30th day, the Liquidated Damages would be 1% or $50,000, (b) at the end of the 60th day, the Liquidated Damages for the first 30-day period would have been 1% or $50,000 and for the second 30-day period would be 2% or $100,000, and (c) at the end of the 105th day, the Liquidated Damages for the first 30-day period would have been 1% or $50,000, for the second 30-day period 2% or $100,000, for the third 30-day period 3% or $150,000, and for the final 15-day period, 4% applied pro rata to such 15 days, or $100,000.

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    There is no cap to the amount of Liquidated Damages that we may be obligated to pay. Payments to be made pursuant to the July 2005 Registration Payment Arrangement will be due and payable to the Purchasers at the end of each calendar month during which Liquidated Damages will have accrued. No Liquidated Damages will be due or payable to a Purchaser in any event if as of the date of the Filing Failure, Effectiveness Failure or Maintenance Failure such Purchaser could sell all of the Registrable Shares such Purchaser then holds without registration by reason of Rule 144(k) of the Securities Act.
 
    The registration statement was filed and declared effective by the SEC on September 2, 2005, which was within the allowed time. As of May 4, 2007, we have not incurred nor paid any Liquidated Damages in connection with the July 2005 Registration Payment Arrangement.
 
    Effective January 1, 2007, we accounted for the July 2005 Registration Payment Arrangement under the provisions of FSP EITF 00-19-2. See Note 1, Significant Accounting Policies — Change in Accounting Principle for Registration Payment Arrangement, for a detailed discussion. As of May 4, 2007, management determined that it is not probable that we will be obligated to pay any Liquidated Damages in connection with the July 2005 Registration Payment Arrangement. Accordingly, no accrual for contingent obligation is required at March 31, 2007.
 
3.   License Fee Revenue
 
    In October 2006, we entered into a license agreement with Theragenex, LLC, a life science and technology company. Under the agreement, we granted Theragenex exclusive rights to develop and commercialize ANX-211, or chitosan gel, in the U.S. in exchange for a licensing fee of $1.0 million ($500,000 of which we received in January 2007, with the remainder due in June 2007), a $1.0 million milestone payment that will be due within 45 days of the launch of each licensed product, and royalties of 15% to 20% on licensed product sales by Theragenex or its sublicensees or affiliates, depending on sales levels. Theragenex, through its wholly-owned subsidiary, TRx Pharma, plans to launch the first licensed product, ZANAFLU®, in the 2007 cold and influenza season. The license agreement remains in effect through the later of the latest date on which the last licensed product is covered by a valid patent claim or 20 years from the date of the first commercial sale of the last licensed product. Either party may terminate the agreement if the other materially breaches or materially defaults in the performance or observance of any of the provisions of the agreement. In addition, either party may, upon notice, terminate the agreement, if the other party admits in writing that it is generally unable to meet its debts when due, or upon the filing of bankruptcy, reorganization, liquidation or receivership proceedings involving such party. Theragenex may terminate the agreement at any time, upon 90 days’ written notice, if Theragenex concludes in good faith, based on technical information learned by it following execution of the agreement, that there is no reasonable likelihood of a commercially viable licensed product. In accordance with the provisions of the SEC’s Staff Accounting Bulletin Topic 13, Revenue Recognition (“Topic 13”), we recognized $500,000 of the license fee as revenue in the three months ended March 31, 2007, because our performance obligations were complete, collectibility was assured and we had no continuing obligations for performance under the agreement.
 
4.   Income Taxes
 
    We adopted the provisions of FIN 48 on January 1, 2007, which did not materially impact our consolidated results of operations or financial position. No unrecognized tax benefits were recorded as of the date of adoption. As a result of the implementation of FIN 48, we did not recognize any liability for unrecognized tax benefits. There are no unrecognized tax benefits included in the balance sheet that would, if recognized, affect the effective tax rate.
 
    Our policy is to recognize interest and/or penalties related to income tax matters in income tax expense. We had no accrual for interest or penalties on our consolidated balance sheets at March 31, 2007 and at December 31, 2006, and have not recognized interest and/or penalties in the consolidated statement of operations for the three months ended March 31, 2007.
 
    At January 1, 2007, we had net deferred tax assets of $20.0 million. The deferred tax assets are primarily composed of federal and state tax net operating loss carryfowards, federal and state R&D credit carryforwards, share-based compensation expense and intangibles. Due to uncertainties surrounding our ability to generate future taxable income to realize these assets, a full valuation allowance has been established to offset our net deferred tax asset. Additionally, the future utilization of our net operating loss and R&D credit carryforwards to offset future taxable income may be subject to a substantial annual limitation as a result of ownership changes that may have occurred previously or that could occur in the future. We have not yet determined whether such an ownership change has occurred, however, we plan to complete a Section 382/383 analysis regarding the limitation of the net operating losses and research and development credits. When this analysis is completed, we plan to update our unrecognized tax benefits under FIN 48. Therefore, we expect that the unrecognized tax benefits may change within 12 months of this reporting date. At this time, we cannot estimate how much the unrecognized tax benefits may change. Any carryforwards that will expire prior to utilization as a result of such limitations will be removed from deferred tax assets with a corresponding reduction of the valuation allowance. Due to the existence of the valuation allowance, future changes in our unrecognized tax benefits will not impact our effective tax rate.
 
5.   Commitments and Contingencies
 
    In the normal course of business, we may become subject to lawsuits and other claims and proceedings. Such matters are subject to uncertainty. Management is not aware of any pending or threatened lawsuit or proceedings that would have a material adverse effect on our consolidated financial position, results of operations or cash flows.

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the consolidated financial statements and related notes appearing elsewhere in this report. In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties, and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of certain factors, including but not limited to those set forth under Item 1A of Part II, “Risk Factors.”
Forward Looking Statements
This Quarterly Report on Form 10-Q, particularly in Item 2 “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including, but not limited to, statements regarding our future financial position, business strategy, clinical trials, partnering arrangements and plans and objectives of management for future operations. When used in this report, the words “believe,” “may,” “could,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect” and similar expressions are intended to identify forward-looking statements.
We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to certain risks and uncertainties that could cause our actual results to differ materially from those expressed or implied in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in Item 1A of Part I, “Risk Factors,” in our Annual Report on Form 10-K for the year ended December 31, 2006 and those discussed in other documents we filed with the Securities and Exchange Commission. Except as required by law, we do not intend to update these forward-looking statements publicly or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this report and in the documents incorporated in this report may not occur and actual results could differ materially and adversely from those anticipated or implied in such forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on such forward-looking statements.
Overview
We are a biopharmaceutical research and development company focused on commercializing proprietary product candidates for the treatment of cancer and infectious diseases. We seek to improve the performance and safety of existing therapeutic products by addressing significant problems such as drug metabolism, bioavailability, excessive toxicity and treatment resistance. Our research and development programs include full clinical and preclinical development programs for new chemical entities for the treatment of various cancers and for the treatment of human immunodeficiency virus, or HIV. We are also developing novel emulsion formulations of several currently marketed products for which we anticipate seeking marketing approval under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, or FDCA, which may allow us to obtain marketing approval of these product candidates on timelines shorter than those associated with traditional development of new chemical entities. We have licensed the U.S. rights to ANX-211, or chitosan gel, to Theragenex LLC that has the potential of generating milestone payments and royalties on product sales beginning in late 2007, and we are in active licensing discussions regarding several of our drug candidates, including our lead product candidate ANX-510 (CoFactor®).
We are currently engaged in clinical development of CoFactor for the treatments of metastatic colorectal cancer and advanced breast cancer. In mid-2006, we began a 1,200-patient Phase 3 clinical trial of CoFactor for the treatment of metastatic colorectal cancer. Enrollment in this trial is currently underway and we anticipate completing enrollment in 2008. Our 300-patient, Phase 2b clinical trial of CoFactor for the treatment of metastatic colorectal cancer is nearing completion and we expect to announce results later in 2007. Also, in December 2006 we began a 31-patient Phase 2 clinical trial of CoFactor for the treatment of advanced breast cancer. Enrollment for that trial is also underway and we anticipate completing enrollment later in 2007.
We are also engaged in clinical development of ANX-530 (vinorelbine emulsion), a new formulation of vinorelbine tartrate, for the treatment of non-small cell lung cancer. We anticipate seeking marketing approval of ANX-530 under Section 505(b)(2) of the FDCA.

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In December 2006, we initiated a 28-patient bioequivalency clinical trial of ANX-530 compared with the currently marketed drug, vinorelbine tartrate. The United States Food and Drug Administration, or FDA, previously indicated that a single 28-patient clinical trial that demonstrates bioequivalence between our emulsion formulation of vinorelbine and the currently marketed product should be sufficient to support filing a new drug application, or NDA, with the FDA. Patient recruitment in the study began in the first quarter of 2007. We anticipate completing enrollment and final data analysis in the second half of 2007. If the study demonstrates bioequivalence, we expect to file an NDA for ANX-530 with the FDA by the end of 2007.
We are engaged in preclinical development of several other product candidates for both cancer and infectious diseases. Preclinical development of ANX-201 (thiophosphonoformate) for the treatment of HIV is ongoing, and we anticipate filing an Investigational New Drug Application, or IND, and initiating a Phase 1/2 clinical trial later in 2007. Additionally, we are engaged in preclinical pharmacokinetic testing of our emulsion formulation product candidates ANX-016 (vancomycin emulsion), for the treatment of certain bacterial infections, and ANX-514 (docetaxel emulsion), for the treatment of certain cancers. Furthermore, we are evaluating potential clinical development of ANX-015 (clarithromycin emulsion). We could commence clinical evaluation on one or more of these emulsion formulation product candidates by the end of 2007. If we are successful in obtaining the FDA’s concurrence in applying the provisions in Section 505 (b)(2), such clinical evaluation work should constitute a marketing-enabling study.
In connection with licensed products, we anticipate that Theragenex, through its wholly-owned subsidiary, TRx Pharma, will launch the first licensed product, ZANAFLU®, for the treatment of the common cold and influenza for the 2007 cold and influenza season. In October 2006, we licensed U.S. rights to ANX-211, one of our proprietary antiviral products, to Theragenex in consideration of a licensing fee, milestone payments and royalty payments of 15% to 20% on licensed product sales by Theragenex or its subsidiaries or affiliates, depending on the sales level. During the three months ended March 31, 2007, Theragenex paid $500,000, or one-half of the license fee, to us, with the balance of the fee due in mid-2007. The license agreement also requires a $1.0 million payment to us shortly following the launch of each licensed product.
We have additional product candidates in our portfolio that we are currently evaluating for future preclinical and clinical development. We intend to continue to build a portfolio of product candidates for the treatment of cancer and infectious diseases that reflect an appropriate balance between the longer-term regulatory pathway associated with traditional drug development and the shorter regulatory timelines available under Section 505(b)(2).
We have incurred annual net losses since inception, and as of March 31, 2007, our accumulated net losses amounted to $82.7 million. Because we are a development stage company that has not yet marketed any products or generated any significant revenue, we intend to raise additional capital to fund operations through the receipt of fees, milestone payments and royalties from license arrangements, and through other forms of financing such as debt financing, royalty-based financing, or sales of shares of our common or preferred stock.
We expect that our research, development, selling, marketing and other operating costs will continue to exceed revenues from existing sources for the foreseeable future. Our total operating expenses are influenced substantially by the amount of spending devoted to our research and development programs. During the last three years, we have expanded our product candidate pipeline, which requires that we allocate significant amounts of our resources to such programs, including increased spending on clinical trials as those programs advance. We expect research and development expenses will represent at least 60% of our operating expenses for 2007. We expect that selling, general and administrative expenses for 2007 will represent less than 40% of our operating expenses. Trends in various types of expenses and revenues are discussed further under “Results of Operations.”
We expect that we will need to raise additional capital if we continue as planned our Phase 3 clinical trial of CoFactor for the treatment of metastatic colorectal cancer without a partner. Our need to raise capital through sales of our securities will depend substantially on our ability to earn revenues through fees, milestone payments and royalties under partnering arrangements regarding our product candidates, including the ability of existing and potentially new partners to generate sales and achieve milestones under such arrangements. If we are unable to raise additional capital as needed to fund our operations, whether through sales of our securities or partnering arrangements, then we may need to slow the rate of development of some of our research and development programs, in particular our Phase 3 and Phase 2b clinical trials of CoFactor, and our development plans for CoFactor and our other product candidates may be adversely affected.

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Critical Accounting Policies
Our discussion and analysis of our financial condition and results of operations is based upon unaudited consolidated financial statements that we have prepared in accordance with U.S. GAAP. The preparation of these consolidated financial statements requires management to make a number of assumptions and estimates that affect the reported amounts of assets, liabilities, revenues and expenses in our consolidated financial statements and accompanying notes. On an on-going basis, we evaluate these estimates and assumptions, including those related to recognition of expenses in research contracts, expenses in research and development, expenses in share-based compensation and registration payment arrangements. Management bases its estimates on historical information and assumptions 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 not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
Change in Accounting Principle for Registration Payment Arrangements. In December 2006, the FASB issued FSP EITF 00-19-2, Accounting for Registration Payment Arrangements. FSP EITF 00-19-2 provides that a contingent obligation to make future payments or otherwise transfer consideration under a registration payment arrangement is separately recognized and measured in accordance with FAS 5 which provides that loss contingencies should be recognized as liabilities if they are probable and reasonably estimable. On January 1, 2007, the first day of our fiscal year ending December 31, 2007, we adopted the provisions of FSP EITF 00-19-2 to account for an outstanding registration payment arrangement. The comparative consolidated financial statements of prior periods have been adjusted to apply the new method retrospectively. See Note 1 in Notes to Condensed Consolidated Financial Statements (unaudited), Change in Accounting Principle for Registration Payment Arrangements, for a detailed discussion.
Income Taxes. In July 2006, FASB issued FIN 48, Accounting for Uncertainty in Income Taxes-an Interpretation of FASB Statement 109, which clarifies the accounting for uncertainty in tax positions. FIN 48 provides that the tax effects from an uncertain tax position can be recognized in our consolidated financial statements only if the position is more likely than not of being sustained upon an examination by tax authorities. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained. Additionally, FIN 48 provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. The provisions of FIN 48 are effective for us as of January 1, 2007, with the cumulative effect of the change in accounting principle recorded as an adjustment to opening retained earnings in the year of adoption. We adopted FIN 48 on January 1, 2007, which did not have a material impact on our consolidated results of operations or financial position.
Revenue Recognition. We recognize revenue in accordance with Topic 13, Revenue Recognition, and EITF No. 00-21, Revenue Arrangements with Multiple Deliverables, or EITF 00-21. Revenue is recognized when all of the following criteria are met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the seller’s price to the buyer is fixed and determinable; and (4) collectibility is reasonably assured.
Revenue from licensing agreements is recognized based on the performance requirements of the agreement. Revenue is deferred for fees received before earned. Nonrefundable upfront fees that are not contingent on any future performance by us are recognized as revenue when revenue recognition criteria under Topic 13 and EITF 00-21 are met and the license term commences. Nonrefundable upfront fees, where we have an ongoing involvement or performance obligations, are recorded as deferred revenue and recognized as revenue over the life of the contract, the period of the performance obligation or the development period, whichever is appropriate in light of the circumstances.
Payments related to substantive, performance-based milestones in an agreement are recognized as revenue upon the achievement of the milestones as specified in the underlying agreements when they represent the culmination of the earnings process. Royalty revenue from licensed products will be recognized when earned in accordance with the terms of the license agreements.
Recognition of Expenses in Research Contracts. Pursuant to management’s assessment of the services that have been performed on clinical trials and other contracts, we recognize expenses as the services are provided. Such management assessments generally consist of, but are not limited to, an evaluation by the project manager of the work that has been completed during the period, measurement of progress prepared internally and/or provided by the third-party service provider, analysis of data that justifies the progress, and finally, management’s judgment. Several of our contracts extend across multiple reporting periods, including our largest contract, with a contract research organization representing a $9.0 million commitment over the life of the contract. A 3% variance in our estimate of the work completed in our largest contract could increase or decrease our operating expenses by approximately $270,000.
Research and Development Expenses. Research and development, or R&D, expenses consist of expenses incurred in performing research and development activities, including salaries and benefits, facilities and other overhead expenses, clinical trials, contract services and other outside expenses. Research and development expenses are charged to operations as they are incurred.

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Payments made in connection with in-licensed technology or product candidates are expensed as incurred when there is uncertainty in receiving future economic benefits from the licensed technology or product candidates. We consider the future economic benefits from the licensed technology or product candidates to be uncertain until such licensed technology or product candidates are approved by the FDA or when other significant risk factors are abated. For expense accounting purposes, management has viewed future economic benefits for all of our licensed technology or product candidates to be uncertain.
Purchased In-Process Research and Development. In accordance with FAS No. 141, Business Combinations, we immediately charge the costs associated with purchased in-process research and development, or IPR&D, to statement of operations upon acquisition. These amounts represent an estimate of the fair value of purchased IPR&D for projects that, as of the acquisition date, had not yet reached technological feasibility, had no alternative future use, and had uncertainty in receiving future economic benefits from the purchased IPR&D. We determine the future economic benefits from the purchased IPR&D to be uncertain until such technology is approved by the FDA or when other significant risk factors are abated. We incurred significant IPR&D expense related to our acquisition of SD Pharmaceuticals, Inc.
Share-based Compensation Expenses. Effective January 1, 2006, we accounted for share-based compensation awards granted to employees in accordance with the revised FAS No. 123, Share-Based Payment, or FAS 123R, including the provisions of Staff Accounting Bulletin No. 107. Share-based compensation cost is measured at the grant date, based on the estimated fair value of the award, and is recognized as expense over the employee’s requisite service period. We have no awards with market or performance conditions. As share-based compensation expense is based on awards ultimately expected to vest, it has been reduced for estimated forfeitures. FAS 123R requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Forfeitures were estimated based on historical experience. Although estimates of share-based compensation expenses are significant to our consolidated financial statements, they are not related to the payment of any cash by us. Prior to January 1, 2006, we accounted for share-based compensation under the recognition and measurement principles of FAS 123, Accounting for Stock-Based Compensation.
We estimate the fair value of stock option awards on the date of grant using the Black-Scholes option-pricing model, or Black-Scholes model. The determination of the fair value of share-based payment awards on the date of grant using an option-pricing model is affected by our stock price as well as assumptions regarding a number of complex and subjective variables. These variables include, but are not limited to, our expected stock price volatility over the term of the awards, actual and projected employee stock option exercise behaviors, a risk-free interest rate and expected dividends. We may elect to use different assumptions under the Black-Scholes option valuation model in the future, which could materially affect our net income or loss and net income or loss per share.
We account for share-based compensation awards granted to non-employees in accordance with EITF No. 96-18, Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services, or EITF 96-18. Under EITF 96-18, we determine the fair value of the share-based compensation awards granted as either the fair value of the consideration received or the fair value of the equity instruments issued, whichever is more reliably measurable. If the fair value of the equity instruments issued is used, it is measured using the stock price and other measurement assumptions as of the earlier of either of (1) the date at which a commitment for performance by the counterparty to earn the equity instruments is reached or (2) the date at which the counterparty’s performance is complete.
The above listing is not intended to be a comprehensive list of all of our accounting policies. In most cases, the accounting treatment of a particular transaction is specifically dictated by U.S. GAAP.
Results of Operations
Comparison of Three Months Ended March 31, 2007 and 2006
Revenue. Revenue for the three months ended March 31, 2007 amounted to $500,000, compared to no revenue for the same period a year ago. Revenue in the first quarter of fiscal year 2007 represents a $500,000 nonrefundable license fee paid under our license agreement with Theragenex. We recognized the license fee as revenue in the period our performance obligations were complete at the time of payment and there were no continuing obligations for us to perform under the agreement. The Theragenex license represents the first license of our technology to a third party. We anticipate that licensing, partnering, and other collaborations will increase in importance as part of our business development strategy through 2007 and 2008; and we are in active discussions with other companies regarding potential arrangements for certain of our other product candidates.

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Research and Development Expenses. R&D expenses increased by $901,000, or 36%, to $3.4 million for the three months ended March 31, 2007, compared to $2.5 million for the comparable period in 2006. The increase in R&D expenses was primarily related to a $390,000 increase in employee compensation and related costs related to an increase in R&D personnel and a $377,000 increase in R&D expenses related to CoFactor for the treatment of metastatic colorectal cancer and treatment of advanced breast cancer, ANX-530 for the treatment of non-small cell lung cancer, and ANX-201 for the treatment of HIV.
We expect that our R&D expenses will continue to increase beyond the level of expenses incurred in the three months ended March 31, 2007 as we continue to ramp up enrollments in our clinical trials, including our Phase 3 clinical trial of CoFactor for the treatment of metastatic colorectal cancer. The amount of the increase in expense will be directly related to the success and speed of patient enrollment in these trials.
Selling, General and Administrative Expenses. Selling, general and administrative, or SG&A, expenses increased by $1.1 million, or 62%, to $2.8 million for the three months ended March 31, 2007, compared to $1.7 million for the comparable period in 2006. The increase in SG&A expenses was due to a $472,000 increase in employee compensation and related costs, a $252,000 increase in legal fees related to patent costs, and a $179,000 increase in market research for our product candidates. We expect that SG&A expenses will continue to increase modestly through 2007 to support increased R&D activity and personnel.
Interest Income. Interest income for the three months ended March 31, 2007 was $622,000 compared to $237,000 for the comparable period in 2006. The increase was attributable to higher invested balances from funds received from our most recent equity financing, which we completed in November 2006, and a higher average interest rate yield on these balances.
Liquidity and Capital Resources
Since our inception we have funded our operations primarily through sales of our equity securities. As of March 31, 2007, we had cash and cash equivalents and short-term investments in securities totaling $47.4 million, compared to $51.7 million as of December 31, 2006. The decrease in cash and investments in securities was attributed to cash used for operations. As of March 31, 2007 we held $21.0 million in cash and cash equivalents and $26.4 million in short-term investments in securities.
Operating Activities. Net cash used in operating activities was $4.6 million during the three months ended March 31, 2007, compared to $3.0 million during the three months ended March 31, 2006. The increase in net cash used in operating activities was due to an increase in payments for research and development activities, primarily related to CoFactor for the treatment of metastatic colorectal cancer and treatment of advanced breast cancer, ANX-530 and ANX-201.
Investing Activities. Net cash used in investing activities was $467,000 during the three months ended March 31, 2007 compared to net cash provided by investing activities of $2.8 million during the three months ended March 31, 2006. Net cash used in investing activities in the first quarter of 2007 was primarily for purchases of short-term investments in securities, net of proceeds from sales and maturities of short-term investments in securities. Cash provided by investing activities in the comparable period in 2006 was primarily attributable to proceeds from sales and maturities of short-term investments in securities, net of purchases of short-term investments in securities.
Financing Activities. No financing activities were conducted during the three months ended March 31, 2007. Net cash provided by financing activities amounted to $2.4 million for the three months ended March 31, 2006. Net cash provided by financing activities in 2006 was primarily proceeds from the exercise of warrants.
Management Outlook
We believe that cash, cash equivalents, and short-term investments of approximately $47.4 million at March 31, 2007 should be sufficient to sustain our planned level of operations for at least the next twelve months. We expect that our cash requirements will be from $6.0 million to $8.0 million in each of the remaining quarters in 2007, as we continue developing our existing product candidates and pipeline. In order to maintain sufficient cash and investments to fund future operations longer term, and to continue developing our existing product candidates, we will need to raise additional capital from time to time, and may do so through various financing alternatives, including selling shares of our common or preferred stock and rights to acquire our common or preferred stock, licensing or selling our technologies and product candidates, or through the issuance of one or more forms of senior or subordinated debt. The balance of securities available for sale under our existing shelf registration was approximately $60.0 million as of March 31, 2007. If we are unable to raise capital as needed to fund future operations, then we may defer or abandon one or more of our clinical or preclinical research programs and may need to take additional cost-cutting measures.

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During the remainder of 2007, we expect to recognize an additional $1.5 million from the licensing of ANX-211 to Theragenex, and may recognize royalties based on the success of its subsidiary, TRx Pharma, in selling licensed products. Additionally, we are in active discussions with potential partners regarding our product candidates, though some of our product candidates could take several more years of development before they reach the stage of being partnerable with other companies on terms that we believe would be acceptable. If we successfully consummate a partnering deal, we may be entitled to license fees and milestone payments that we may recognize in 2007. Of course, any such fees and payments will depend on successfully consummating a deal and achieving milestones under such arrangements.
Recent Accounting Pronouncements
See Note 1, Summary of Significant Accounting Policies — Recent Accounting Pronouncements, in the Notes to Unaudited Condensed Consolidated Financial Statements for a discussion of recent accounting pronouncements and their effect, if any, on the Company.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
We are not subject to any meaningful market risk related to foreign currency exchange rates, commodity prices or similar market risks. Substantially all of our expenses and capital purchasing activities are transacted in U.S. dollars. We are sensitive to interest rate fluctuations. The primary objective of our investing activities is to preserve principal while maximizing the income we receive from our investments without significantly increasing the risk of loss. Some of the investable securities permitted under our cash management policy may be subject to market risk for changes in interest rates. To mitigate this risk, we maintain a portfolio of cash equivalent and short-term investments in a variety of securities which may include investment grade commercial paper, money market funds, government debt issued by the United States of America, state debt, certificates of deposit and investment grade corporate debt. Presently, we are exposed to minimal market risks associated with interest rate changes because of the relatively short maturities of our investments and we do not expect interest rate fluctuations to materially affect the aggregate value of our financial instruments. We manage our sensitivity to these risks by maintaining investment grade short-term investments. Our cash management policy does not allow us to purchase or hold derivative or commodity instruments or other financial instruments for trading purposes. Additionally, our policy stipulates that we periodically monitor our investments for adverse material holdings related to the underlying financial solvency of the issuer. As of March 31, 2007, our investments consisted mostly of cash, commercial paper and U.S. government debt. Our results of operations and financial condition would not be significantly impacted by either a 10% increase or decrease in interest rates due mainly to the short-term nature of our investment portfolio. We have not used derivative financial instruments in our investment portfolio. Additionally, we do not invest in foreign currencies or other foreign investments.
Item 4. Controls and Procedures.
Evaluation of disclosure controls and procedures
As of the end of the period covered by this report, we conducted an evaluation, under the supervision and with the participation of our principal executive officer and principal financial officer, of the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the “Exchange Act”). Based on this evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures are effective to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in Securities and Exchange Commission rules and forms and is accumulated and communicated to our management, including our principal executive and principal financial officer, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
Changes in Internal Control over Financial Reporting
There was no change in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the period covered by this report 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 1. Legal Proceedings.
In the normal course of business, we may become subject to lawsuits and other claims and proceedings. Such matters are subject to uncertainty and outcomes are often not predictable with assurance. We are not aware of any pending or threatened material legal proceedings.
Item 1A. Risk Factors.
An investment in our securities involves a high degree of risk. You should consider carefully the risks and uncertainties described under Item 1A of Part I of our Annual Report on Form 10-K for the year ended December 31, 2006, which is incorporated by reference into this quarterly report. The risks described in our Annual Report have not materially changed.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None
Item 3. Defaults Upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of Security Holders
None.
Item 5. Other Information
None.
Item 6. Exhibits.
An Exhibit Index has been attached as part of this quarterly report and is incorporated herein by reference.

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Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
         
          ADVENTRX Pharmaceuticals, Inc.
 
 
Date: May 8, 2007  By:   /s/ Evan M. Levine    
    Evan M. Levine   
    Chief Executive Officer
(Principal Executive Officer) 
 
 
     
Date: May 8, 2007  By:   /s/ Gregory P. Hanson    
    Gregory P. Hanson, CMA   
    Chief Financial Officer, Senior Vice President,
Finance, and Treasurer
(Principal Financial and Accounting Officer) 
 

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Exhibit Index
     
Exhibit   Description
10.1*
  Second Amendment to Option and License Agreement, effective as of January 25, 2007, between the registrant and the University of Southern California
 
   
10.2
  Separation Agreement and Release of Claims, dated February 2, 2007, between the registrant and Robert A. Daniel
 
   
10.3
  Consulting Agreement, dated February 2, 2007, between the registrant and Robert A. Daniel
 
   
31.1
  Certification of chief executive officer pursuant to Rule 13a-14(a)/15d-14(a)
 
   
31.2
  Certification of chief financial officer pursuant to Rule 13a-14(a)/15d-14(a)
 
   
32.1**
  Certification of chief executive officer and chief financial officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
 
*   Indicates that confidential treatment has been requested for certain portions of this exhibit (as indicated by asterisks). We have filed separately with the Securities and Exchange Commission an unredacted copy of this exhibit.
 
**   This certification is being furnished solely to accompany this report pursuant to 18 U.S.C. 1350, and are not being filed for purposes of Section 18 of the Securities Exchange Act of 1934 and are not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 

exv10w1
 

Exhibit 10.1
SECOND AMENDMENT TO OPTION AND LICENSE AGREEMENT
     This Second Amendment to Option and License Agreement (this “Amendment”) is entered into effective as of January 25, 2007 (the “Effective Date”) by and between Adventrx Pharmaceuticals, Inc., a Delaware corporation formerly known as BioKeys Pharmaceuticals, Inc. and BioKeys, Inc. (the “Company”), and the University of Southern California, a California nonprofit corporation (“USC”).
     WHEREAS, the Company and USC are parties to that certain Option and License Agreement, dated August 17, 2000, as amended pursuant to that certain Amendment to Option and License Agreement between USC and the Company, dated April 21, 2003 (the “Agreement”);
     NOW, THEREFORE, in consideration of the terms and conditions set forth below, the Company and USC hereby agree as follows:
     1. Field of Use. Section 2(c) of the Agreement is hereby amended and restated to read in its entirety to read in full as follows:
“FIELD OF USE’ shall mean diagnosis, treatment and/or prevention of viral infections.”
     2. Patent Prosecution Expenses. Section 7(e) of the Agreement is hereby amended and restated in its entirely to read in full as follows:
“If the Licensee decides to terminate this Agreement pursuant to the second sentence of Paragraph 16, Licensee shall reimburse the reasonable legal expenses incurred by USC for up to one (1) month from the date written notification of termination is sent by Licensee.”
     3. Termination. The third sentence of Section 16(a) of the Agreement is hereby amended and restated in its entirety to read in full as follows:
“Licensee may also terminate this Agreement at any time, for any reason, by providing USC a thirty (30) day written notice and reimbursing the reasonable legal expenses incurred by USC for up to one (1) month from the date written notification of termination is sent by Licensee.”
     4. Termination. A new sentence shall be added at the end of Section 16(a) of the Agreement as follows:
“The foregoing notwithstanding, should Licensee fail to achieve the milestones set forth in Section 26(b), USC shall have the option to terminate this Agreement only by providing written notice of termination to Licensee within one (1) month of the applicable milestone deadline.”
     5. Product Development. Section 26 of the Agreement is hereby amended to include three sections: the existing paragraph shall be designated as 26(a), and a new 26 (b) and 26(c) shall be added as follows:

 


 

     “b. Licensee shall file an Investigational New Drug (IND) application with the US FDA (or a foreign equivalent with an equivalent foreign authority in Canada, France, Germany, Sweden, Switzerland or the United Kingdom (collectively, the “European Countries”)) for the PRODUCT no later than ***. Licensee shall initiate at least one clinical trial for the PRODUCT on or before ***. Licensee shall file a New Drug Application (NDA), abbreviated NDA or any successor to such forms with the US FDA (or foreign equivalent of any of the foregoing in one of the European Countries or via the EMEA Centralized Process) for the PRODUCT on or before ***.”
     “c. From time to time as a result of this Agreement, including in connection with the reports and/or during the visits and presentations described in Section 26(a), the Licensee may disclose confidential information relating to Licensee’s business. USC agrees (i) to hold such information in strict confidence and to take reasonable measures to protect such information, (ii) not to divulge such information or any information derived therefrom to any third party and (iii) not to make any use whatsoever at any time of such information other than to evaluate Licensee’s obligations under this Section 26. Anyone to whom USC gives access to such information must have a legitimate “need to know” and be bound in writing by confidentiality and non-use obligations at least as restrictive as those set forth in this Section 26(c). These obligations will continue until such time as such information is publicly known or generally available through no action or inaction of USC or anyone to whom it gave access to such information.”
     6. Internal Reference. The Company and USC agree that any reference in the Agreement to “this Agreement” (or other similar reference) will be a reference to the Agreement, as amended.
     7. Conflicts. Except to the extent amended herein, the Agreement remains in full force and effect.
[Signature page follows]
 
*** Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commission.

 


 

     IN WITNESS WHEREOF, the Company and USC have executed this Second Amendment to Option and License Agreement in duplicate originals effective as of the Effective Date.
         
COMPANY:   ADVENTRX PHARMACEUTICALS, INC.
 
   
 
  By:   /s/ Evan Levine
 
     
 
 
 
  Name:   Evan Levine
 
     
 
 
 
  Title:   Chief Executive Officer
 
     
 
 
 
       
USC:   UNIVERSITY OF SOUTHERN CALIFORNIA
 
       
 
  By:   /s/ Dennis F. Dougherty
 
     
 
 
 
  Name:   Dennis F. Dougherty
 
     
 
 
 
  Title:   Senior Vice President, Finance and CFO
 
     
 
 
[COUNTERPART SIGNATURE PAGE TO SECOND AMENDMENT TO OPTION AND
LICENSE AGREEMENT]

 

exv10w2
 

Exhibit 10.2
SEPARATION AGREEMENT AND RELEASE OF CLAIMS
(initially provided to Mr. Daniel on January 22, 2007)
(provided to Mr. Daniel as amended on January 30, 2007)
(provided to Mr. Daniel as further amended on February 1, 2007)
     This Separation Agreement and Release of Claims (this “Separation Agreement”) is made by and between ADVENTRX Pharmaceuticals, Inc. (the “Company”), a Delaware corporation, and Robert A. Daniel (“Mr. Daniel”) (collectively, the “Parties”).
RECITALS
     WHEREAS, the Parties have agreed to transition Mr. Daniel’s responsibilities and duties to the Company in a considered and professional manner;
     WHEREAS, Mr. Daniel will conclude his employment with the Company, as described herein;
     WHEREAS, after the conclusion of Mr. Daniel’s employment with the Company, Mr. Daniel wishes to serve as a consultant to the Company, and the Company wishes to retain Mr. Daniel as a consultant;
     WHEREAS, the Parties desire an amicable separation of employment and to resolve any and all claims, disputes, issues, or matters that were asserted or could be asserted;
     NOW THEREFORE, in consideration of the promises, covenants and agreements set forth herein, and subject to the terms and conditions set forth below, the Parties desire to, and hereby do, agree as follows:
     1. Mr. Daniel’s employment with the Company will terminate effective February 15, 2007 (the “Termination Date”);
     2. The Company will retain Mr. Daniel, and Mr. Daniel agrees to provide, services as an independent contractor on the terms provided in the independent contractor agreement attached hereto as Exhibit A (including the Company’s Confidential Information and Invention Assignment Agreement referenced therein) (the “Consulting Agreement”). The Parties agree that, concurrent with the signing of this Separation Agreement, they will sign the Consulting Agreement and that the effectiveness of the Consulting Agreement will be concurrent with the effectiveness of the termination of Mr. Daniel’s employment with the Company. For clarification, the Parties agree that Mr. Daniel will remain in Continuous Service (as defined in the Company’s 2005 Equity Incentive Plan) to the Company for so long as the Consulting Agreement remains in effect but in no event beyond March 30, 2007.

 


 

     3. On the Termination Date, the Company will make available to Mr. Daniel his final paycheck for wages and all earned and unused vacation. This payment is not dependent upon Mr. Daniel signing this Separation Agreement. In addition, in exchange for Mr. Daniel agreeing to be bound by the terms of this Separation Agreement and the Consulting Agreement and performing his obligations hereunder and thereunder (including, without limitation, granting the release set forth in Section 4), the Company will provide Mr. Daniel with the following benefits to which he otherwise would not be entitled:
     3.1 Six (6) months of pay, payable in a lump sum on March 30, 2007, based on Mr. Daniel’s current base salary, less all the required withholdings and taxes; provided however, that both (a) Mr. Daniel has not terminated the Consulting Agreement prior to March 30, 2007 and (b) the Company has not terminated the Consulting Agreement prior to March 30, 2007 as a result of Mr. Daniel’s material breach of the Consulting Agreement (including the Company’s Confidential Information and Invention Agreement referenced therein).
     3.2 If Mr. Daniel chooses to elect continuation of coverage under the federal law known as COBRA, the Company will continue to pay Mr. Daniel’s medical, dental and vision premium through September 30, 2007, unless he becomes eligible for coverage under another group insurance plan before that date.
     3.3 Mr. Daniel acknowledges and agrees that, (a) upon his receipt of the final paycheck described in Section 3, the Company has paid all salary, wages, bonuses, commissions, vacation pay, floating holiday pay and other benefits or compensation due Mr. Daniel from the Company and (b) but for this Separation Agreement, Mr. Daniel is not entitled to the benefits set forth in Sections 3.1 or 3.2 and that, in the event Mr. Daniel fails to fully perform under this Separation Agreement or the Consulting Agreement, the Company has no obligation to provide, or continue to provide, such benefits.
     4. Releases.
     4.1 Mr. Daniel, for himself and his heirs, agents, assigns, executors, administrators, representatives, successors and each of them, unconditionally, irrevocably and absolutely releases and discharges the Company, and each of its current, former and future parents, subsidiaries, divisions, partnerships, employee benefit plans and other related and affiliated entities of the Company and their respective employees, officers, directors, agents, predecessors, successors, fiduciaries, consultants, attorneys and assigns (collectively “Released Parties”), from all claims related in any way to the transactions or occurrences between them to date, to the fullest extent permitted by law, including, but not limited to, Mr. Daniel’s employment with the Company, the termination of his employment, and all other losses, liabilities, claims, demands and causes of action, known or unknown, suspected or unsuspected, arising directly or indirectly out of or in any way connected with Mr. Daniel’s employment with the Company and the termination

2


 

of that employment. This release is intended to have the broadest possible application permitted by law and includes, but is not limited to, any tort, contract, common law, constitutional or statutory claims and all claims for attorneys’ fees, costs and expenses. Notwithstanding the foregoing, this release shall not serve as a waiver of Mr. Daniel’s rights to: (i) vested benefits due to his employment with the Company, (ii) workers compensation or unemployment benefits, (iii) statutorily-required indemnification under California Labor Code Section 2802 or any comparable provisions of other states’ laws, or (iv) any other benefits or claims that cannot be released as a matter of law.
     4.2 The Company, and each of its current, former and future parents, subsidiaries, divisions, partnerships, employee benefit plans and other related and affiliated entities of the Company and their respective employees, officers, directors, agents, predecessors, successors, fiduciaries, consultants, attorneys and assigns and each of them, unconditionally, irrevocably and absolutely releases and discharges Mr. Daniel and his heirs, agents, assigns, executors, administrators, representatives, successors (collectively, “Releasees”) from all claims related in any way to the transactions or occurrences between them to date, to the fullest extent permitted by law, including but not limited to, Mr. Daniel’s employment with the Company, the termination of his employment, and all other losses, liabilities, claims, demands and causes of action, known or unknown, suspected or unsuspected, arising directly or indirectly out of or in any way connected with Mr. Daniel’s employment with the Company and the termination of that employment. This release is intended to have the broadest possible application permitted by law and includes, but is not limited to, any tort, contract, common law, constitutional or statutory claims and all claims for attorneys’ fees, costs and expenses.
     4.3 Each of the Parties declares and represents that it intends this Separation Agreement to be complete and not subject to any claim of mistake, and that the release herein expresses a full and complete release and, regardless of the adequacy or inadequacy of the consideration, the Parties intend the releases to be final and complete. The Parties execute this Separation Agreement with the full knowledge that the releases contained in it covers all possible claims against the Released Parties and the Releasees, as applicable, to the fullest extent permitted by law.
     5. Acknowledgement of Understanding. Each of the Parties acknowledges that it may discover facts or law different from, or in addition to, the facts or law that it knows or believes to be true with respect to the claims released in this Separation Agreement and agrees, nonetheless, that this Separation Agreement and the releases contained in it shall be and remain effective in all respects notwithstanding such different or additional facts or the discovery of them. Each of the Parties expressly acknowledges and agrees that its rights under Section 1542 of the California Civil Code and any comparable provisions of other states’ and federal law are expressly waived. That section provides:

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A general release does not extend to claims which the creditor does not know or suspect to exist in his or her favor at the time of executing the release, which if known by him or her must have materially affected his or her settlement with the debtor.
     Each of the Parties expressly acknowledges, agrees and understands that the general release give in Section 4 applies to all unknown, unsuspected and unanticipated claims, liabilities and causes of action that it may have against any of the Released Parties or the Releasees, as applicable.
     6. Pursuit of Released Claims. Each of the Parties represents that, as of the date of this Separation Agreement, it has not filed any lawsuits, charges, complaints, petitions, claims or other accusatory pleadings against any of the Released Parties or Releasees, as applicable, in any court or with any governmental agency. Each of the Parties further agrees that, to the fullest extent permitted by law, it will not prosecute, nor allow to be prosecuted on his behalf, in any court, whether state or federal, any claim or demand of any type related to the matters released herein, it being the intention of each of the Parties that with the execution of this Separation Agreement, the Released Parties and the Releasees will each be absolutely, unconditionally and forever discharged of and from all obligations to or on behalf of the Releasees and the Released Parties, respectively, related in any way to the matters discharged herein. Each of the Parties further represents that it has not assigned any claim it may have against any of the Released Parties or Releasees, as applicable, to any other person or entity. Nothing in this Separation Agreement limits either of the Parties’ right to file a charge or complaint with any state or federal agency or to participate or cooperate in such a matter, but each of the Parties acknowledges that it is not entitled to any other monies other than those payments described in this Separation Agreement.
     7. Continuing Obligations. Mr. Daniel represents that, on or before the Termination Date, he will return to the Company all Company documents, information and property, including (without limitation) files, records, computer access codes and instruction manuals, as well as any of the Company’s assets or equipment that Mr. Daniel has in his possession or are under his control, unless and to the extent the Company determines such property is necessary for Mr. Daniel to perform under the Consulting Agreement (in which case the use and return of such property will be governed by the Consulting Agreement). Subject to the foregoing, Mr. Daniel further agrees not to keep any copies of any Company documents or information. In addition to the terms and conditions of the Consulting Agreement, Mr. Daniel acknowledges and agrees that he will continue to be bound by (a) the Confidential Information, Non-Solicitation and Invention Assignment Agreement for Employees entered into between the Company and Mr. Daniel (the “Company Agreement”), (b) the Code of Business Conduct and Ethics for Employees, Executive Officers and Directors executed by Employee (the “Code of Ethics”) and (c) the Policies and Procedure Manual executed by Employee (the “Manual), copies of all of which have been provided to Employee.

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     8. Expense Reimbursement. By signing this Separation Agreement, Mr. Daniel agrees to submit all outstanding reimbursements he incurred as an employee of the Company to the Company on or before the Termination Date.
     9. Nondisparagement. Mr. Daniel will not make any voluntary statements, written or verbal, or cause or encourage others to make any such statements that defame, disparage or in any way criticize the Company’s business reputation, practices or conduct. The Company will not make any voluntary statements, written or verbal, or cause or encourage others to make any such statements that defame, disparage or in any way criticize Mr. Daniel, or his business reputation, practices or conduct. The foregoing notwithstanding, the Parties may respond accurately and fully to any questions, inquiry or request for information when required to do so by legal process.
     10. Arbitration of Disputes and Enforcement of Agreement.
     10.1 Mr. Daniel and the Company agree to resolve any claims they may have against each other or that Mr. Daniel has with any of the other Released Parties through final and binding arbitration. This agreement to arbitrate applies to any and all disputes about the validity, interpretation, or effect of this Separation Agreement or alleged violations of it and whether a particular claim is covered by this Separation Agreement. Except as provided in Section 10.2 and Section 10.3, arbitration shall be the exclusive remedy for any such claim or dispute, and the Parties expressly waive their rights to a jury trial on any such claim or dispute. However, either party may bring an action in court to compel arbitration under this Separation Agreement or to enforce an arbitration award. The Parties agree that a neutral arbitrator from the American Arbitration Association will administer any such arbitration(s) pursuant to its National Rules for the Resolution of Employment Disputes. The arbitrator shall issue a written decision with the essential findings and conclusions on which the decision is based.
     10.2 The requirement to arbitrate disputes shall not preclude either of the Parties from filing a charge or claim with a state or federal government agency. However, Mr. Daniel acknowledges that he is not entitled to any other monies other than those payments described in this Separation Agreement.
     10.3 Nothing in this Section 10 shall preclude either Party from seeking interim or provisional relief in the form of a temporary restraining order, preliminary injunction, or other interim relief concerning a dispute prior to or during an arbitration pursuant to this Section 10 necessary to protect the interests of such Party.

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     11. Older Workers’ Benefit Protection Act. This Separation Agreement is intended to satisfy the requirements of the Older Workers’ Benefit Protection Act, 29 U.S.C. sec. 626(f). The following general provisions, along with the other provisions of this Separation Agreement, are agreed to for this purpose:
     11.1 Mr. Daniel acknowledges and agrees that he has read and understands the terms of this Separation Agreement.
     11.2 Mr. Daniel acknowledges that this Separation Agreement advises him in writing that he may consult with an attorney before executing this Separation Agreement, and that he has obtained and considered such legal counsel as he deems necessary, such that he is entering into this Separation Agreement freely, knowingly and voluntarily.
     11.3 Mr. Daniel acknowledges that he has been given at least twenty-one (21) days in which to consider whether or not to enter into this Separation Agreement. Mr. Daniel understands that, at his option, he may elect not to use the full twenty-one (21) day period.
     11.4 Mr. Daniel shall have seven (7) full calendar days after signing this Separation Agreement to revoke this Separation Agreement. This Separation Agreement will not become effective until the expiration of the revocation period. Mr. Daniel’s revocation of this Separation Agreement must be in writing and received by Patrick Keran, General Counsel, no later than Noon on the eighth day in order to be effective. If Mr. Daniel does not revoke acceptance within the seven (7) day period, this Separation Agreement will become fully effective and enforceable on the eighth day after the Separation Agreement is signed (the “Effective Date”).
     11.5 Mr. Daniel does not waive or release any rights or claims that he may have under the Age Discrimination in Employment Act that arise after the execution of this Separation Agreement. Mr. Daniel is not waiving his right to file a complaint or charge with the EEOC (including a challenge to the validity of this Separation Agreement) or participate in any investigation or proceeding conducted by the EEOC.

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     12. Confidentiality. Mr. Daniel agrees to keep this Separation Agreement confidential and not to reveal its contents or terms to anyone except Mr. Daniel’s lawyer, spouse and/or financial consultant.
     13. Miscellaneous. This Separation Agreement is intended to be the entire agreement between the Parties and supersedes and cancels any and all other prior agreements, written or oral, between the Parties regarding this subject matter, except the Consulting Agreement, the Company Agreement, the Code of Ethics and the Manual, each of which will remain in full force and effect until it terminates, expires or no longer applies pursuant to its terms or as set forth herein. Mr. Daniel represents that, in executing this Separation Agreement, he is not relying and has not relied on any representation or statement made by any of the Released Parties or any of their respective agents, attorneys or representatives with regard to the subject matter, basis or effect of this Separation Agreement, or otherwise, other than those specifically set forth in this Separation Agreement. This Separation Agreement may not be modified except by a writing signed by both Mr. Daniel and an authorized officer of the Company and will be binding upon Mr. Daniel and his heirs, agents, assigns, executors, administrators, representatives, successors. In the event any provision of this Separation Agreement is found to be unenforceable by an arbitrator or a court of competent jurisdiction, the provision will be deemed modified to the extent necessary to allow enforceability of the provision as so limited, it being intended that the Company will receive the benefits contemplated herein to the fullest extent permitted by law and all other provisions will remain fully enforceable. This Agreement shall be governed by the laws of the State of California.
     14. Counterparts. This Separation Agreement may be executed by facsimile or facsimile signature, and in separate counterparts, each of which shall be deemed an original but all of which, when taken together, shall constitute one and the same instrument.
     IN WITNESS WHEREOF, I have executed this Agreement and have acknowledged that I executed the same as my own free act and deed.
         
Date
  February 2, 2007   /s/ Robert A. Daniel
 
       
 
      Robert A. Daniel
 
       
Date
  Feb 2, 2007   /s/ Gregory P. Hanson
 
       
 
      ADVENTRX Pharmaceuticals, Inc.

7


 

EXHIBIT A
CONSULTING AGREEMENT

8

exv10w3
 

Exhibit 10.3
ADVENTRX PHARMACEUTICALS, INC.
CONSULTING AGREEMENT
     This Consulting Agreement (this “Agreement”) is dated February 2, 2007 but will become effective (the “Effective Date”) as of and concurrent with the termination of the employment relationship of Robert A. Daniel , an individual resident of the State of California (“Consultant”), with ADVENTRX Pharmaceuticals, Inc., a Delaware corporation (the “Company”).
     1. Consulting Relationship. During the term of this Agreement, Consultant will provide consulting services (the “Services”) to the Company as described on Exhibit A attached to this Agreement. Consultant represents that Consultant is duly licensed (as applicable) and has the qualifications, the experience and the ability to properly perform the Services. Consultant shall use Consultant’s best efforts to perform the Services such that the results are satisfactory to the Company and in conformance with the Code of Professional Ethics of the AICPAA. Consultant shall provide Services only as requested by the Company.
     2. Fees. As consideration for the Services to be provided by Consultant and other obligations, the Company shall pay to Consultant the amounts specified in Exhibit B attached to this Agreement at the times specified therein.
     3. Expenses. Consultant shall not be authorized to incur on behalf of the Company any expenses.
     4. Term and Termination. Consultant shall serve as a consultant to the Company for a period commencing on the Effective Date and terminating upon written notice of termination from the Company to Consultant or from Consultant to the Company; provided, however, that the Company may not terminate this Agreement prior to March 30, 2007 unless Consultant is in material breach of this Agreement, the Confidentiality Agreement (as defined below) or that certain Separation Agreement and Release of Claims by and between the Company and Consultant and initially provided to Consultant on January 22, 2007 (and provided to Consultant as amended on January 30, 2007 and as further amended on February 1, 2007).
     5. Independent Contractor. Consultant’s relationship with the Company will be that of an independent contractor and not that of an employee.
          (a) Method of Provision of Services. Consultant shall be solely responsible for determining the method, details and means of performing the Services. Consultant may not employ or engage the service of any third parties to perform the Services required by this Agreement.
          (b) No Authority to Bind Company. Neither Consultant, nor any partner, agent or employee of Consultant, has authority to enter into contracts that bind the Company or create obligations on the part of the Company without the prior written authorization of the Company.

 


 

          (c) No Benefits. Consultant acknowledges and agrees that Consultant (or Consultant’s employees, if Consultant is an entity) will not be eligible for any Company employee benefits and, to the extent Consultant (or Consultant’s employees, if Consultant is an entity) otherwise would be eligible for any Company employee benefits but for the express terms of this Agreement, Consultant (on behalf of itself and its employees) hereby expressly declines to participate in such Company employee benefits.
          (d) Withholding; Indemnification. Consultant shall have full responsibility for applicable withholding taxes for all compensation paid to Consultant, its partners, agents or its employees under this Agreement, and for compliance with all applicable labor and employment requirements with respect to Consultant’s self-employment, sole proprietorship or other form of business organization, and Consultant’s partners, agents and employees, including state worker’s compensation insurance coverage requirements and any US immigration visa requirements. Consultant agrees to indemnify, defend and hold the Company harmless from any liability for, or assessment of, any claims or penalties with respect to such withholding taxes, labor or employment requirements, including any liability for, or assessment of, withholding taxes imposed on the Company by the relevant taxing authorities with respect to any compensation paid to Consultant or Consultant’s partners, agents or its employees.
     6. Supervision of Consultant’s Services. All of the services to be performed by Consultant, including but not limited to the Services, will be as agreed between Consultant and the Company’s chief financial officer. Consultant will be required to report to the Company’s chief financial officer concerning the Services performed under this Agreement. The nature and frequency of these reports will be left to the discretion of the Company’s chief financial officer.
     7. Confidentiality Agreement. Consultant shall sign, or has signed, the Company’s current Confidential Information and Invention Assignment Agreement (the “Confidentiality Agreement”) on or before the Effective Date.
     8. Conflicts with this Agreement. Consultant represents and warrants that neither Consultant nor any of Consultant’s partners, employees or agents is under any pre-existing obligation in conflict or in any way inconsistent with the provisions of this Agreement. Consultant represents and warrants that Consultant’s performance of all the terms of this Agreement will not breach any agreement to keep in confidence proprietary information acquired by Consultant in confidence or in trust prior to commencement of this Agreement. Consultant warrants that Consultant has the right to disclose and/or or use all ideas, processes, techniques and other information, if any, which Consultant has gained from third parties, and which Consultant discloses to the Company or uses in the course of performance of this Agreement, without liability to such third parties. Notwithstanding the foregoing, Consultant agrees that Consultant shall not bundle with or incorporate into any deliveries provided to the Company herewith any third party products, ideas, processes, or other techniques, without the express, written prior approval of the Company. Consultant represents and warrants that Consultant has not granted and will not grant any rights or licenses to any intellectual property or technology that would conflict with Consultant’s obligations under this Agreement. Consultant will not knowingly infringe upon any copyright, patent, trade secret or other property right of

-2-


 

any former client, employer or third party in the performance of the Services required by this Agreement.
     9. Miscellaneous.
          (a) Amendments and Waivers. Any term of this Agreement may be amended or waived only with the written consent of the parties.
          (b) Sole Agreement. This Agreement, including the Exhibits hereto, constitutes the sole agreement of the parties and supersedes all oral negotiations and prior writings with respect to the subject matter hereof. The foregoing notwithstanding, the Company and Consultant acknowledge that this Agreement is entered into in connection with that certain Severance Agreement and Release of All Claims, dated of even date herewith (the “Severance Agreement”), and that this Agreement has no effect on the Severance Agreement or any of the documents or other agreements referenced therein or executed in connection therewith.
          (c) Notices. Any notice required or permitted by this Agreement shall be in writing and shall be deemed sufficient upon receipt, when delivered personally or by courier, overnight delivery service or confirmed facsimile, 48 hours after being deposited in the regular mail as certified or registered mail (airmail if sent internationally) with postage prepaid, if such notice is addressed to the party to be notified at such party’s address or facsimile number as set forth below, or as subsequently modified by written notice.
          (d) Choice of Law. The validity, interpretation, construction and performance of this Agreement shall be governed by the laws of the State of California as applied to agreements among California residents entered into and to be performed entirely within California.
          (e) Severability. If one or more provisions of this Agreement are held to be unenforceable under applicable law, the parties agree to renegotiate such provision in good faith. In the event that the parties cannot reach a mutually agreeable and enforceable replacement for such provision, then (i) such provision shall be excluded from this Agreement, (ii) the balance of the Agreement shall be interpreted as if such provision were so excluded and (iii) the balance of the Agreement shall be enforceable in accordance with its terms.
          (f) Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed an original, but all of which together will constitute one and the same instrument.
          (g) Arbitration. Any dispute or claim arising out of or in connection with any provision of this Agreement will be finally settled by binding arbitration in San Diego County, California, in accordance with the rules of the American Arbitration Association by one arbitrator appointed in accordance with said rules. The arbitrator shall apply California law, as applied to agreements among California residents entered into and to be performed entirely within California, to the resolution of any dispute. Judgment on the award rendered by the arbitrator may be entered in any court having jurisdiction thereof. Notwithstanding the foregoing, the parties may apply to any court of competent jurisdiction for preliminary or interim

-3-


 

equitable relief, or to compel arbitration in accordance with this paragraph, without breach of this arbitration provision. This Section 10(g) shall not apply to the Confidentiality Agreement.
          (h) Advice of Counsel. EACH PARTY ACKNOWLEDGES THAT, IN EXECUTING THIS AGREEMENT, SUCH PARTY HAS HAD THE OPPORTUNITY TO SEEK THE ADVICE OF INDEPENDENT LEGAL COUNSEL, AND HAS READ AND UNDERSTOOD ALL OF THE TERMS AND PROVISIONS OF THIS AGREEMENT. THIS AGREEMENT SHALL NOT BE CONSTRUED AGAINST ANY PARTY BY REASON OF THE DRAFTING OR PREPARATION HEREOF.
[Signature Page Follows]

-4-


 

     The parties have executed this Agreement on the respective dates set forth below.
         
    ADVENTRX PHARMACEUTICALS, INC.
 
       
 
  By:   /s/ Gregory P. Hanson
 
     
 
 
 
  Title:   SVP & CFO
 
     
 
 
 
  Address:   6725 Mesa Ridge Road, Suite 100
 
      San Diego, CA 92121
 
       
    ROBERT A. DANIEL
 
       
    /s/ Robert A. Daniel
     
 
  Signature    
 
       
 
  Address:   5639 Amaga Dr., #309
 
      La Mesa, CA 91942

 


 

EXHIBIT A
DESCRIPTION OF CONSULTING SERVICES
     
Description of Services   Schedule/Deadline
 
   
Consultant will:
  Not applicable
    Make himself available during normal business hours at the Company’s offices to perform consulting services as requested by the Company.  
         
    Respond to inquiries of the Company’s personnel regarding financial and accounting matters, and such other matters related to the Company regarding which Consultant has knowledge.  
         
    Make himself available and use his best efforts in the transition of his former duties to designated representatives or employees of the Company. Such efforts include, but are not limited to, providing corporate records, files and other materials.  
         
    Provide advice and assistance regarding special projects, conference appearances or any other matter consistent with Consultant’s background, skills and experience.  

 


 

EXHIBIT B
COMPENSATION
From the Effective Date through March 30, 2007, provided this Agreement has not been terminated, the Company will compensate Consultant as follows (pro-rated for any portion of a calendar month during which this Agreement is effective based on a 30-day month):
          On February 28, 2007, an amount equal to $6,751.57
          On March 15, 2007, an amount equal to $6,751.57
          On March 30, 2007, an amount equal to $6,751.57
Payment will be due within 5 days of each date set forth above or, if this Agreement is terminated prior to March 30, 2007, within 5 days of the date of termination.
Following March 30, 2007 and in the event this Agreement is not terminated, the Company and Consultant will mutually agree in writing upon the compensation to be paid by the Company to Consultant for on-going services, if any, to be provided by Consultant to the Company. For clarification, following March 30, 2007 (a) the Company will have no obligation whatsoever to compensate Consultant until such time as such compensation is agreed upon in writing, if at all and (b) Consultant will have no obligation whatsoever to provide services to the Company until such time as such compensation is agreed upon in writing, if at all.

 

exv31w1
 

Exhibit 31.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Evan M. Levine, certify that:
1.   I have reviewed this Quarterly Report on Form 10-Q of ADVENTRX Pharmaceuticals, Inc.;
 
2.   Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
 
3.   Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
 
4.   The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)), for the registrant and have:
  a.   Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
 
  b.   Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
 
  c.   Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
 
  d.   Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.   The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):
  a.   All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
 
  b.   Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: May 8, 2007
         
     
  /s/ Evan M. Levine    
  Evan M. Levine   
  Chief Executive Officer
(Principal Executive Officer) 
 

 

exv31w2
 

         
Exhibit 31.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Gregory P. Hanson, certify that:
1.   I have reviewed this Quarterly Report on Form 10-Q of ADVENTRX Pharmaceuticals, Inc.;
 
2.   Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
 
3.   Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
 
4.   The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)), for the registrant and have:
  a.   Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
 
  b.   Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
 
  c.   Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
 
  d.   Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.   The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions):
  a.   All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
 
  b.   Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: May 8, 2007
         
     
  /s/ Gregory P. Hanson    
  Gregory P. Hanson, CMA   
  Senior Vice President, Chief Financial Officer
(Principal Financial and Accounting Officer) 
 

 

exv32w1
 

         
Exhibit 32.1
Certification of 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
In connection with the Quarterly Report of ADVENTRX Pharmaceuticals, Inc. (the “Company”) on Form 10-Q for the quarter ended March 31, 2007, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Evan M. Levine, Chief Executive Officer of the Company, certify for the purposes of section 1350 of chapter 63 of title 18 of the United States Code that, to the best of my knowledge,
(i) the Report fully complies with the requirements of section 13(a) of the Securities Exchange Act of 1934, and
(ii) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: May 8, 2007
         
     
  /s/ Evan M. Levine    
  Evan M. Levine   
  Chief Executive Officer   
 
In connection with the Quarterly Report of ADVENTRX Pharmaceuticals, Inc. (the “Company”) on Form 10-Q for the quarter ended March 31, 2007, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Gregory P. Hanson, Senior Vice President, Chief Financial Officer of the Company, certify for the purposes of section 1350 of chapter 63 of title 18 of the United States Code that, to the best of my knowledge,
(i) the fully complies with the requirements of section 13(a) of the Securities Exchange Act of 1934, and
(ii) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: May 8, 2007
         
     
  /s/ Gregory P. Hanson    
  Gregory P. Hanson, CMA   
  Senior Vice President, Chief Financial Officer