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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 10-Q

|X| QUARTERLY REPORT PURSUANT TO SECTION 12 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2004

or

|_| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Commission file number 000-25571

AXONYX INC.
(Exact name of registrant as specified in its charter)

Nevada
(State or other jurisdiction of
incorporation or organization)
86-0883978
(IRS Employer Id. No.)

500 Seventh Avenue, 10th Floor
New York, New York 10018

(Address of principal executive offices)

Registrant’s telephone number, including area code: (212) 645-7704

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes |X| No |_|.

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act). Yes |_| No |X|.

As of November 10, 2004 the Registrant had outstanding 53,039,155 shares of its $.001 par value Common Stock.




AXONYX INC.

INDEX

PART I.     FINANCIAL INFORMATION        
           
Item 1. Condensed Consolidated Financial Statements    
           
Condensed Consolidated Balance Sheets as of September 30, 2004 (unaudited)    
and December 31, 2003       1  
           
    Condensed Consolidated Statements of Operations (unaudited) for the three    
    and nine months ended September 30, 2004 and 2003       2  
           
    Condensed Consolidated Statements of Changes in Stockholders’ Equity    
    (unaudited) for the nine months ended September 30, 2004       3  
           
    Condensed Consolidated Statements of Cash Flows (unaudited) for the nine    
    months ended September 30, 2004 and 2003       4  
                 
      Notes to Condensed Consolidated Financial Statements       5  
           
Item 2. Management’s Discussion and Analysis of Financial Condition and    
Results of Operations       9  
                 
Item 3. Quantitative and Qualitative Disclosures About Market Risk       17  
                 
Item 4. Controls and Procedures       18  
                 
PART II. OTHER INFORMATION       18  
                 
Item 6. Exhibits       18  
                 
Signatures             19  



 

 

PART I. FINANCIAL INFORMATION

 

Item 1. Condensed Consolidated Financial Statements


AXONYX INC.

Condensed Consolidated Balance Sheets


ASSETS September 30,
2004
December 31,
2003
     
      (unaudited)        
Current Assets:            
     Cash and cash equivalents     $ 87,664,000   $ 28,780,000  
     Accounts receivable       370,000  
     Inventories       349,000  
     Other current assets       206,000  

                 
              Total current assets       88,589,000     28,780,000  
                 
     Equipment, net       88,000     24,000  
           
     Technology for developed products, net       6,996,000  
     Patents and patents pending, net       969,000  
     Security deposit       18,000     11,000  

                 
      $ 96,660,000   $ 28,815,000  

     
LIABILITIES    
Current liabilities:    
     Accounts payable     $ 3,036,000   $ 1,284,000  
     Accrued expenses       2,524,000     880,000  
     Note payable       160,000  
     Convertible bridge loans       404,000  

          Total liabilities       6,124,000     2,164,000  
     
STOCKHOLDERS’ EQUITY    
Preferred stock - $.001 par value, 15,000,000 shares authorized; none issued    
Common Stock - $.001 par value, 150,000,000 and 75,000,000 shares authorized;    
     as of 2004 and 2003 respectively; 51,706,222 and 33,919,948 shares    
     issued and outstanding in 2004 and 2003 respectively       51,000     34,000  
Additional paid-in capital       144,238,000     60,345,000  
Unearned compensation - stock options       (177,000 )    
Accumulated comprehensive loss       (32,000 )
Accumulated deficit       (53,544,000 )   (33,728,000 )

                 
              Total stockholders’ equity       90,536,000     26,651,000  

                 
              Total liabilities and stockholders’ equity     $ 96,660,000   $ 28,815,000  

See notes to condensed consolidated financial statements.

1



AXONYX INC.

Condensed Consolidated Statements of Operations
(unaudited)

Three months ended Sept 30, NIne months ended September 30,
2004
2003
2004
2003
                             
Revenue                    
    Licensing     $ 450,000   $   $ 450,000   $ 1,000,000  
    Product sales       504,000         1,415,000      




Total revenue       954,000         1,865,000     1,000,000  
Cost of product sales       282,000         786,000      




Gross profit       672,000         1,079,000     1,000,000  
     
Costs and expenses:    
     Research and development       6,054,000   $ 986,000     15,888,000     3,262,000  
     Sales, general and administrative       1,540,000     844,000     6,038,000     2,434,000  




        7,594,000     1,830,000     21,926,000     5,696,000  




                             
Loss from operations       (6,922,000 )   (1,830,000 )   (20,847,000 )   (4,696,000 )
     
Other income (expense)    
     Interest income       379,000     22,000     805,000     59,000  
     Foreign exchange       (3,000 )   5,000     (40,000 )   13,000  
     Gain on issuance of subsidiary stock       16,000         71,000      
     Financing fees       (164,000 )       (464,000 )    
     Interest expense       (13,000 )       (38,000 )    




Net loss before minority interest in subsidiary       (6,707,000 )   (1,803,000 )   (20,513,000 )   (4,624,000 )
                             
Minority interest in loss of subsidiary       14,000         697,000      




                             
Net loss       (6,693,000 )   (1,803,000 )   (19,816,000 )   (4,624,000 )
     
Comprehensive loss    
     Foreign currency translation adjustment       2,000         (32,000 )    




                             
Comprehensive loss     $ (6,691,000 ) $ (1,803,000 ) $ (19,848,000 ) $ (4,624,000 )




                             
Net loss per common share     $ (0.13 ) $ (0.07 ) $ (0.40 ) $ (0.18 )




                                  
Weighted average shares-basic and diluted       51,701,443     27,398,419     48,974,854     25,107,598  

See notes to condensed consolidated financial statements.

2



AXONYX INC.

Condensed Consolidated Statements of Changes in Stockholders’ Equity
(unaudited)


  Common Stock
Additional
Paid-in
Capital

Unearned
Compensation
Stock
Options

  Accumulated
Deficit

  Accumulated
Other
Comprehensive
Loss

  Total
Stockholders’
Equity

 
Number
of
Shares

Amount
Balance - December 31, 2003           33,919,948       $ 34,000      $ 60,345,000      $      $ (33,728,000 )    $      $ 26,651,000  
               
Issuance of common stock and warrants - net of expenses       12,727,106     13,000     64,745,000                 64,758,000  
     
Issuance of common stock for the acquisition of 53% of    
     Oxis International Inc.       1,618,061     1,000     8,193,000                 8,194,000  
Issuance of common stock options and warrants    
    for consulting services               1,504,000                 1,504,000  
Issuance of common stock options               387,000     (387,000 )            
                                               
Exercise of common stock warrants and options       3,441,107     3,000     9,064,000                 9,067,000  
                                               
Amortization                   210,000             210,000  
                                           
Foreign currency translation adjustment                           (32,000 )   (32,000 )
                                           
Net loss                       (19,816,000 )       (19,816,000 )







                                           
Balance - September 30, 2004       51,706,222   $ 51,000   $ 144,238,000   $ (177,000 ) $ (53,544,000 ) $ (32,000 ) $ 90,536,000  








See notes to condensed consolidated financial statements.

3



AXONYX INC.
Condensed Consolidated Statements of Cash Flows

(unaudited)


Nine months ended September 30,