EX-99.1 2 dex991.htm PRESS RELEASE Press Release

EXHIBIT 99.1

 

Sontra Medical Corporation Reports First Quarter 2004 Financial Results

 

FRANKLIN, Mass., May 10 — Sontra Medical Corporation (Nasdaq SC: SONT) announced today financial results for the first quarter ended March 31, 2004. For the three months ended March 31, 2004, the net loss applicable to common stockholders was $1,403,000, or $.11 per share, as compared to $951,000, or $.10 per share, for the same period in 2003.

 

The Company’s cash balance increased from $4,869,000 at December 31, 2003 to $6,273,000 at March 31, 2004. On January 15, 2004, the Company received a $1.5 million payment from Bayer Health Care LLC’s Diagnostic Division pursuant to a license agreement executed in July 2003 for Sontra’s non-invasive glucose monitoring technology. Also during the first quarter, Sontra realized net proceeds of $1,036,000 from the exercise of warrants to purchase common stock issued in 2003.

 

First Quarter 2004 Highlights:

 

  In February, the FDA granted the Company the first 510(k) marketing clearance for SonoPrep(R) for use in electrophysiology applications.

 

  In early March, the Company submitted a 510(k) application for a second indication, seeking marketing clearance to use SonoPrep and its topical lidocaine procedure tray to achieve rapid skin anesthesia. This FDA submission was supported by data from three clinical studies involving approximately 500 patients that demonstrates that rapid skin anesthesia with 4% lidocaine was achieved within five minutes following a skin pretreatment with SonoPrep.

 

  During the quarter, the Company received approximately $2.54 million from a licensing payment and the exercise of warrants.

 

“We made solid progress during the first quarter in developing and expanding the value of our product pipeline,” stated Thomas W. Davison, PhD, Sontra’s President and Chief Executive Officer. “SonoPrep skin permeation technology clearly improves the clinical utility of topical lidocaine because existing products addressing this $100 million market require up to a 60- minute waiting period compared to five minutes following a skin pretreatment with SonoPrep before effective skin anesthesia is achieved. We expect to launch our product for this indication during the third quarter of 2004, assuming FDA 510(k) marketing clearance. Additionally, during 2004 we plan to conduct clinical studies demonstrating that SonoPrep enables transdermal delivery of vaccines and other pain drugs.”

 

About Sontra Medical Corporation

 

Sontra Medical Corporation is the pioneer of SonoPrep, a non-invasive ultrasound-mediated skin permeation technology that enables transdermal diagnosis and drug delivery. Sontra’s products under development include: a continuous non-invasive glucose monitor developed in collaboration with Bayer Diagnostics; a rapid onset (less than 5 minutes) topical anesthetic delivery system and the use of SonoPrep for the transdermal delivery of large molecule drugs and biopharmaceuticals. For additional information, please visit the Company’s website at www.sontra.com.


SonoPrep is a registered trademark of Sontra Medical Corporation. All other company, product or service names mentioned herein are the trademarks or registered trademarks of their respective owners.

 

This press release contains forward-looking statements, which address a variety of subjects including, for example, the expected future operating and financial results, including the sufficiency of cash balances to fund operations, the expected benefits, efficacy and market opportunity of the SonoPrep device and technology and related applications, and the expected timing of the commercial availability of the SonoPrep device and lidocaine procedure tray. Statements that are not historical facts, including statements about our beliefs and expectations, are forward-looking statements. Such statements are based on our current expectations and are subject to a number of factors and uncertainties, which could cause actual results to differ materially from those described in the forward-looking statements. The following important factors and uncertainties, among others, could cause actual results to differ materially from those described in these forward- looking statements: Sontra’s success depends on its ability to execute on its business strategy; Sontra may face difficulties or delays in obtaining regulatory approvals to market products resulting from development efforts; Sontra may experience adverse results in product development, clinical trials and commercialization efforts; Sontra may fail to obtain and maintain patent protection for discoveries; Sontra’s business strategy depends, in part, upon strategic partners to develop and commercialize products based on our work; and Sontra requires substantial funding to conduct research and development and to expand commercialization activities in accordance with its business plans. For detailed information about factors that could cause actual results to differ materially from those described in the forward-looking statements, please refer to Sontra’s filings with the Securities and Exchange Commission, including Sontra’s most recent Quarterly Report on Form 10-QSB. Forward- looking statements represent management’s current expectations and are inherently uncertain. We do not undertake any obligation to update forward-looking statements made by us.


SONTRA MEDICAL CORPORATION

 

Consolidated Statements of Loss

 

(Unaudited)

 

     For the Three Months Ended
March 31,


 
     2004

    2003

 

Revenues

   $ —       $ —    

Operating Expenses:

                

Research and development

     675,907       541,352  

General and administrative

     527,494       418,433  
    


 


Total operating expenses

     1,203,401       959,785  
    


 


Loss from operations

     (1,203,401 )     (959,785 )

Interest income

     14,229       9,106  
    


 


Net loss

     (1,189,172 )     (950,679 )

Accretion of dividend and beneficial conversion feature on Series A Convertible Preferred Stock

     (213,434 )     —    
    


 


Net loss applicable to common shareholders

   $ (1,402,606 )   $ (950,679 )
    


 


Net loss per common share, basic and diluted

   $ (0.11 )   $ (0.10 )
    


 


Basis and diluted weighted average common shares outstanding

     12,711,051       9,360,938  
    


 



SONTRA MEDICAL CORPORATION

 

Consolidated Balance Sheets

 

     As of

 
    

March 31,

2004


   

December 31,

2003


 
     (Unaudited)        

Assets:

                

Current Assets:

                

Cash and cash equivalents

   $ 6,272,650     $ 4,868,933  

Accounts receivable

     —         1,500,000  

Prepaid expenses and other current assets

     114,728       66,075  
    


 


Total current assets

     6,387,378       6,435,008  
    


 


Property and Equipment, at cost

                

Computer equipment

     174,847       171,272  

Office and laboratory equipment

     407,735       405,285  

Furniture and fixtures

     14,288       14,288  

Manufacturing equipment

     180,608       144,695  

Leasehold improvements

     166,289       166,289  
    


 


       943,767       901,829  

Less-Accumulated depreciation and amortization

     (534,835 )     (498,341 )
    


 


Net property and equipment

     408,932       403,488  
    


 


Other Assets:

                

Restricted cash

     48,746       48,746  

Other assets

     2,000       2,000  
    


 


Total other assets

     50,746       50,746  
    


 


Total assets

   $ 6,847,056     $ 6,889,242  
    


 


Liabilities and Stockholders’ Equity

                

Current Liabilities:

                

Accounts payable

   $ 126,001     $ 136,810  

Accrued expenses

     283,600       465,092  
    


 


Total current liabilities

     409,601       601,902  
    


 


Commitments

                

Stockholders’ Equity:

                

Series A Convertible Preferred Stock, $0.01 par value, authorized 7,000,000 shares, issued and outstanding 2,987,500 shares at March 31, 2004 and 6,495,000 shares at December 31, 2003 (preference in liquidation of $3,105,148)

     3,105,148       6,628,842  

Common stock, $0.01 par value, authorized 40,000,000 shares, issued and outstanding 14,521,635 shares at March 31, 2004 and 10,102,992 shares at December 31, 2003

     145,216       101,030  

Additional paid-in capital

     22,802,718       17,952,721  

Deferred stock-based compensation

     (404,076 )     (372,874 )

Accumulated deficit

     (19,211,551 )     (18,022,379 )
    


 


Total stockholders’ equity

     6,437,455       6,287,340  
    


 


Total liabilities and stockholders’ equity

   $ 6,847,056     $ 6,889,242