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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 


 

FORM 10-Q

 


 

(Mark One)

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

 

For the quarterly period ended March 31, 2004

 

or

 

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

 

For the transition period from              to             

 

Commission File Number: 000-19122

 


 

APHTON CORPORATION

(Exact name of registrant as specified in its charter)

 


 

Delaware   95-3640931

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

80 SW 8th Street, Miami, Florida   33130
(address of principal executive offices)   (Zip Code)

 

(305) 374-7338

(Registrant’s telephone number, including area code)

 

 

(Former name, former address and former fiscal year, if changed since last report)

 


 

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  x    No  ¨

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date:

 

Class


 

Number of Shares outstanding


 

As of


Common Stock, $0.001 par value   37,630,558   April 30, 2004

 



Table of Contents

APHTON CORPORATION

 

Index
     Page

Part I - Financial Information

   1

Item 1. Financial Statements:

   1

Balance Sheets – March 31, 2004 (unaudited) and December 31, 2003

   2

Statements of Operations (unaudited) - Three months ended March 31, 2004 and 2003

   3

Statements of Cash Flows (unaudited) - Three months ended March 31, 2004 and 2003

   4

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

   7

Item 3. Quantitative and Qualitative Disclosures About Market Risk

   14

Item 4. Controls and Procedures

   14

Part II - Other Information

   15

Item 6. Exhibits and Reports on Form 8-K

   15

Signatures

   16

 

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Part I - Financial Information

 

Item 1. Financial Statements

 

The interim financial statements included herein have been prepared by us, without audit, pursuant to the rules and regulations of the Securities and Exchange Commission. In the opinion of management, the financial statements include all adjustments (consisting of normal recurring entries) necessary to present fairly our financial position as of March 31, 2004 and December 31, 2003 and the results of our operations for the three months ended March 31, 2004 and 2003; and our cash flows for the three months ended March 31, 2004 and 2003. It is suggested that these financial statements be read in conjunction with the financial statements and the notes thereto included in our latest annual report on Form 10-K.

 

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APHTON CORPORATION

Balance Sheets

 

    

March 31,

2004


    December 31,
2003


 
     (Unaudited)        
Assets                 

Current assets:

                

Cash and current investments:

                

Cash and short-term cash investments

   $ 61,275,828     $ 18,378,988  

Investment securities-trading

     888,250       836,587  
    


 


Total cash and current investments

     62,164,078       19,215,575  

Other assets (including current portion of unconditional supply commitment)

     431,639       517,627  
    


 


Total current assets

     62,595,717       19,733,202  

Equipment and improvements, at cost, net of accumulated depreciation and amortization

     154,379       158,534  

Deferred financing costs, net of accumulated amortization of $15,043 as of March 31, 2004 and $8,990 as of December 31, 2003

     549,957       556,010  

Unconditional supply commitment

     6,797,900       6,797,900  
    


 


Total assets

   $ 70,097,953     $ 27,245,646  
    


 


Liabilities and Stockholders’ Equity (Deficit)                 

Liabilities:

                

Current liabilities:

                

Trade accounts payable

   $ 1,618,526     $ 1,604,435  

Due to related party

     3,234,000       3,234,000  

Accrued liabilities

     1,253,555       1,114,464  

Accrued interest payable

     382,500       630,000  
    


 


Total current liabilities

     6,488,581       6,582,899  

Convertible debentures, net of discount of $12,008,733 as of March 31, 2004 and $12,261,508 as of December 31, 2003

     10,991,267       10,738,492  

Deferred revenue

     10,000,000       10,000,000  
    


 


Total liabilities

     27,479,848       27,321,391  
    


 


Commitments

                

Stockholders’ equity (deficit):

                

Preferred stock, $0.001 par value - Authorized: 4,000,000 shares; Issued and outstanding: none

     —         —    

Common stock, $0.001 par value - Authorized: 60,000,000 shares; Issued and outstanding: 37,564,464 shares at March 31, 2004 and 29,217,257 shares at December 31, 2003

     37,564       29,217  

Additional paid in capital

     215,408,945       166,501,394  

Purchase warrants

     298,900       298,900  

Accumulated deficit

     (173,127,304 )     (166,905,256 )
    


 


Total stockholders’ equity (deficit)

     42,618,105       (75,745 )
    


 


Total liabilities and stockholders’ equity (deficit)

   $ 70,097,953     $ 27,245,646  
    


 


 

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

 

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APHTON CORPORATION

Statements of Operations (Unaudited)

For the three months ended March 31, 2004 and 2003

 

    

Three months ended

March 31,


 
     2004

    2003

 

Revenue:

   $ —       $ —    
    


 


Costs and expenses:

                

General and administrative

Research and development

    
 
812,452
4,790,980
 
 
   
 
580,462
4,269,734
 
 
    


 


Total costs and expenses

     5,603,432       4,850,196  
    


 


Loss from operations

     (5,603,432 )     (4,850,196 )
    


 


Other income (expense):

                

Dividend and interest income

     24,848       13,710  

Interest expense including amortized discount

     (641,328 )     (82,500 )

Unrealized losses from investments

     (2,137 )     (3,961 )
    


 


Net loss

   $ (6,222,049 )   $ (4,922,947 )
    


 


Per share data:

                

Basic and fully diluted loss per common share

   $ (0.20 )   $ (0.20 )
    


 


Weighted average number of common shares outstanding

     31,890,259       24,534,972  
    


 


 

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APHTON CORPORATION

Statements of Cash Flows (Unaudited)

For the three months ended March 31, 2004 and 2003

 

    

Three Months Ended

March 31,


 
     2004

    2003

 

Cash flows from operating activities:

                

Cash paid to suppliers and employees

   $ (5,709,849 )   $ (4,022,169 )
    


 


Net cash used in operating activities

     (5,709,849 )     (4,022,169 )
    


 


Cash flows from investing activities:

                

Capital expenditures

     (9,209 )     —    
    


 


Net cash used in investing activities

     (9,209 )     —    
    


 


Cash flows from financing activities:

                

Proceeds from sale of common stock and warrants

     48,615,898       1,219,251  
    


 


Net cash received from financing activities

     48,615,898       1,219,251  
    


 


Net increase (decrease) in cash and short-term cash investments

     42,896,840       (2,802,918 )

Cash and short-term cash investments:

                

Beginning of period

     18,378,988       7,824,182  
    


 


End of period

   $ 61,275,828     $ 5,021,264  
    


 


Reconciliation of net loss to net cash used in operating activities                 

Net loss

   $ (6,222,049 )   $ (4,922,947 )
    


 


Adjustments to reconcile net loss to net cash used in operating activities:

                

Common stock issued for interest payment

     300,000          

Depreciation and amortization

     13,364       25,432  

Amortization of deferred financing costs

     6,053       —    

Amortization of discount on convertible debentures

     252,775       —    

Unrealized loss on investments

     2,137       3,961  

Non-cash employee compensation expense

     (2,137 )     (3,961 )

Changes in -

                

Investment securities - trading

     (53,801 )     (45,276 )

Other assets

     85,989       44,214  

Current liabilities

     (92,180 )     876,408  
    


 


Net cash used in operating activities:

   $ (5,709,849 )   $ (4,022,169 )
    


 


 

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Notes to the Financial Statements (unaudited)

 

1. Organization and Operations

 

Aphton is a biopharmaceutical company focused on the development and commercialization of pharmaceutical products for the treatment of cancer and gastrointestinal disease. Aphton’s research and development efforts are based on its proprietary active immunization and monoclonal antibody technologies. Aphton’s technologies are based on key discoveries made by it as well as its deep understanding of the central role of gastrin, a naturally occurring hormone, and gastrin receptors. It is well documented in scientific literature that gastrin and gastrin receptors are critical to the onset, development, growth and spread of adenocarcinomas of the gastrointestinal system, including those found in the esophagus, stomach, pancreas, liver and throughout the colon and rectum.

 

Aphton’s lead product candidate is an immunotherapeutic called G17DT. Aphton has completed one Phase III clinical trial and it is in a second Phase III clinical trial for the treatment of pancreatic cancer with G17DT. Aphton also recently completed testing of G17DT in one Phase II clinical trial for the treatment of gastric cancer and one Phase II clinical trial for the treatment of colorectal cancer. On October 30, 2003, Aphton announced positive results from its Phase III randomized, double-blinded, placebo-controlled clinical trial of G17DT as monotherapy in patients with pancreatic cancer. Treatment with G17DT resulted in a median survival of 151 days, compared with 83 days for patients treated with placebo. Aphton has generated additional positive data in multiple human clinical trials using G17DT. In its studies to date, virtually no systemic toxicity has been observed. By comparison, currently approved drugs for the treatment of gastric, pancreatic and colorectal cancers have significant side effects.

 

Aphton’s fiscal year end was changed in March, 2001 from January 31 to December 31, effective for the 11 month period ending December 31, 2001.

 

2. Summary of Significant Accounting Policies

 

Comprehensive Loss

 

The net loss for the three months ended March 31, 2004 and 2003 was the comprehensive loss for those periods.

 

Earnings (loss) per share

 

At March 31, 2004, shares of our common stock issuable upon the exercise of approximately 1.7 million warrants and 3.9 million options were excluded from the computation of net loss per share because their effect was anti-dilutive. At March 31, 2003, shares of our common stock issuable upon the exercise of approximately 0.2 million warrants and 3.5 million options were excluded from the computation of net loss per share because their effect was anti-dilutive.

 

Stock-Based Compensation

 

On December 31, 2002, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards (“SFAS”) No. 148, Accounting for Stock-Based Compensation — Transition and Disclosure. This Statement amends SFAS No. 123, Accounting for Stock-Based Compensation, to provide alternative methods of transition for an entity that voluntarily changes to the fair value based method of accounting for stock-based employee compensation. It also amends the disclosure provisions of that Statement to require prominent disclosure about the effects on reported net income of an entity’s

 

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accounting policy decisions with respect to stock-based employee compensation. Finally, this Statement amends APB Opinion No. 28, Interim Financial Reporting, to require disclosure about those effects in interim financial information. We intend to continue to account for stock-based compensation based on the provisions of APB Opinion No. 25.

 

The following table summarizes our results as if we had recorded stock-based employee compensation expense for the three months ended March 31, 2004 and 2003, based on the provisions of SFAS 123, as amended by SFAS 148:

 

     March 31,
2004


    March 31,
2003


 

Net loss:

                

As reported

   $ (6,222,049 )   $ (4,922,947 )

Compensation expense, net of tax

     (831,872 )     (255,168 )
    


 


Pro forma

   $ (7,053,921 )   $ (5,178,115 )
    


 


Basic loss per share:

                

As reported

   $ (0.20 )   $ (0.20 )

Compensation expense, net of tax

     (0.02 )     (0.01 )
    


 


Pro forma

   $ (0.22 )   $ (0.21 )
    


 


Diluted loss per share:

                

As reported

   $ (0.20 )   $ (0.20 )

Compensation expense, net of tax

     (0.02 )     (0.01 )
    


 


Pro forma

   $ (0.22 )   $ (0.21 )
    


 


 

Reclassifications

 

Interest expense amounts have been reclassified in the March 31, 2003 presentation to conform to the 2004 presentation.

 

3. March 2004 sale of common stock

 

In March 2004, the Company sold 8,050,000 shares of registered common stock at $6.50 per share or approximately $52.3 million and received net proceeds of approximately $48.6 million, after deducting all costs related to the sale of the common stock.

 

4. Convertible Debentures

 

As of March 31, 2004 and December 31, 2003 we have outstanding $23.0 million in convertible debentures. There was an initial discount calculated against the value of the notes of $12.9 million, comprised of the beneficial conversion feature of $8.3 million and other discounts of $4.6 million on the notes. The unamortized discount as of March 31, 2004 is $12.0 million which is offset against the $23.0 million and is shown as $11.0 million of convertible debentures in the accompanying financial statements. Of this amount, $3.0 million is our Series A Convertible Debenture. Our Series A Convertible Debenture is a convertible, redeemable, five-year note that matures on December 19, 2007. The Series A Convertible Debenture bears interest at a rate of 11.0% per annum, payable annually. The debenture is convertible at the holder’s option at a conversion price equal to the average closing price of our common stock, as defined in the debenture, at the time of conversion. The Series A Convertible Debenture contains provisions that place a cap on the number of shares of our common stock issuable upon its conversion, such that the holder thereof shall not have the right to convert any portion of the Series A Convertible Debenture to the extent that after giving effect to such conversion the holders would beneficially own more than 19.99% of the number of shares of our common stock outstanding immediately prior to such conversion.

 

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The remaining $20.0 million in convertible notes were issued in two tranches to accredited investors during the three months ended June 30, 2003. On April 4, 2003, we issued $15.0 million of convertible, redeemable, 5-year, interest-bearing senior convertible notes (which we refer to as our 2003 senior convertible notes) and 5-year warrants to purchase an aggregate total of 1,080,000 shares of our common stock to various accredited investors. On June 12, 2003 we issued an additional $5 million of our 2003 senior convertible notes and a 5-year warrant to purchase an aggregate total of 360,000 shares of our common stock to an accredited investor. The senior convertible notes mature on March 31, 2008. The senior convertible notes bear interest at a rate of 6.0% per annum, payable quarterly in cash or shares of our common stock, at our option.

 

The senior convertible notes are convertible at a fixed price of $2.50 per share, unless otherwise adjusted prior to conversion pursuant to the price adjustment provisions set forth therein. The conversion price of the senior convertible notes will be lowered in the event of a sale by us of our common stock or securities convertible into our common stock at a per share offering price less than the conversion price of the senior convertible notes in effect immediately prior to such sale. The warrants are exercisable into shares of our common stock at $2.70 per share, unless otherwise adjusted prior to exercise pursuant to the price adjustment provisions that are substantially similar to those set forth in the senior convertible notes. The senior convertible notes and the warrants contain provisions that place a cap on the numbers of shares of our common stock issuable upon their conversion or exercise, such that the holders thereof shall not have the right to convert any portion of the notes to the extent that after giving effect to such conversion the holders would beneficially own more than 19.99% or 4.99%, as the case may be for the respective holder, of the number of shares of our common stock outstanding immediately prior to such conversion or exercise.

 

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

 

Overview

 

General

 

We are a biopharmaceutical company focused on the development and commercialization of pharmaceutical products for the treatment of cancer and gastrointestinal disease. Our research and development efforts are based on our proprietary active immunization and monoclonal antibody technologies. Our lead product candidate is an immunotherapeutic called G17DT. We currently have, in various stages, clinical trials testing G17DT in the treatment of various gastrointestinal cancers and non-cancer diseases. We believe that our human data and the safety profile of G17DT support the broad applicability and corresponding commercial potential for this therapy in gastrointestinal cancer.

 

Financial Operations

 

We do not have any products approved for sale in the United States or abroad. Therefore, we do not generate any revenue from the sale of our products. We have experienced significant operating losses since our inception in 1981 and expect to continue incurring significant operating losses for at least the next several years. We expect losses to continue over the next several years as we continue our clinical trials, apply for regulatory approvals and continue our research and development efforts. We also expect to experience negative operating cash flows for the foreseeable future. Our losses have adversely impacted, and will continue to adversely impact, our working capital, total assets and stockholders’ equity.

 

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Our net loss for the quarter ended March 31, 2004 was $6.2 million and as of March 31, 2004, we had an accumulated deficit of approximately $173.1 million. Our operating losses are primarily due to the costs of development of our potential products. These costs can vary significantly from year to year depending on the number of potential products in development, the stage of development of each potential product, the number of patients enrolled in and complexity of clinical trials and other factors. Our ability to achieve profitability depends upon our ability, alone or through relationships with third parties, to develop successfully our technology and products, to obtain required regulatory approvals and to manufacture, market and sell such products. It is possible that we may never be profitable.

 

Because we have not yet generated any revenue from the sale of our products, we have primarily relied on the capital markets as our source of funding. In addition, we may seek funding through arrangements with collaborative partners or others that may require us to relinquish rights to certain of our technologies, potential products or products that we would otherwise seek to develop or commercialize ourselves. These collaborations may take the form of strategic alliances with other drug companies. If funding from these various sources is not available at reasonable terms, we may be required to reduce our operating expenses in order to conserve cash and capital by delaying, reducing the scop