-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, CzW7bmgZUeY4T6FcqaYGH4eD9dYZRg/IU2N/3nWjI8TVGcwsac+XexZkoG3eae+h 5JuUIT7daIe1nkm8efkC8A== 0000927016-03-001621.txt : 20030404 0000927016-03-001621.hdr.sgml : 20030404 20030404092304 ACCESSION NUMBER: 0000927016-03-001621 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20030331 ITEM INFORMATION: Financial statements and exhibits ITEM INFORMATION: Regulation FD Disclosure FILED AS OF DATE: 20030404 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SONTRA MEDICAL CORP CENTRAL INDEX KEY: 0001031927 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 411649949 STATE OF INCORPORATION: MN FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-23017 FILM NUMBER: 03639461 BUSINESS ADDRESS: STREET 1: 58 CHARLES STREET CITY: CAMBRIDGE STATE: MA ZIP: 02141 BUSINESS PHONE: 6174945337 MAIL ADDRESS: STREET 1: 58 CHARLES STREET CITY: CAMBRIDGE STATE: MA ZIP: 02141 FORMER COMPANY: FORMER CONFORMED NAME: INTELLIPHONE INC DATE OF NAME CHANGE: 19970625 FORMER COMPANY: FORMER CONFORMED NAME: CHOICETEL COMMUNICATIONS INC /MN/ DATE OF NAME CHANGE: 19970625 FORMER COMPANY: FORMER CONFORMED NAME: SONTRA MEDICAL CORP DATE OF NAME CHANGE: 20020701 FORMER COMPANY: FORMER CONFORMED NAME: CHOICETEL COMMUNICATIONS INC/MN/ DATE OF NAME CHANGE: 20020701 8-K 1 d8k.htm FORM 8-K FORM 8-K

 

SECURITIES AND EXCHANGE COMMISSION

 

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported): March 31, 2003

 

SONTRA MEDICAL CORPORATION


(Exact Name of Registrant as Specified in Its Charter)

 

Minnesota


(State or Other Jurisdiction of Incorporation)

 

0 230-17


 

41-1644949


(Commission File Number)

 

(IRS Employer Identification No.)

 

10 Forge Parkway, Franklin, Massachusetts


 

02038


(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (508) 553-8850


 

ITEM 7.    FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS

 

(c) Exhibits

 

Exhibit No.


  

Description


99.1

  

Press Release issued by Sontra Medical Corporation (the “Company”), dated March 31, 2003, announcing the Company’s financial results for the fourth quarter and fiscal year ended December 31, 2002.

 

ITEM 9.    REGULATION FD DISCLOSURE

 

This information is being submitted pursuant to Item 12 of Form 8-K (Results of Operations and Financial Conditions). The Company issued a press release on March 31, 2003, a copy of which is attached as Exhibit 99.1 to this report and incorporated herein by this reference, in which it announced financial results for the fourth quarter and fiscal year ended December 31, 2002. This information shall not be deemed to be “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934 and shall not be deemed to be incorporated by reference in any filing under the Securities Act of 1933. The Company disclaims any intention or obligation to update or revise this information. The submission of this report on Form 8-K is not an admission as to the materiality of any information in this report that is required to be disclosed solely by Regulation FD.


 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

       

Sontra Medical Corporation

April 3, 2003

     

By:

 

/s/    Thomas W. Davison


               

Thomas W. Davison

President and Chief Executive Officer

 


 

EXHIBIT INDEX

 

Exhibit No.


  

Description


99.1

  

Press Release issued by Sontra Medical Corporation, dated March 31, 2003, announcing financial results for the fourth quarter and fiscal year ended December 31, 2002.

EX-99.1 3 dex991.htm PRESS RELEASE PRESS RELEASE

 

Exhibit 99.1

 

FOR IMMEDIATE RELEASE

 

Contact: Sean Moran, CFO

Sontra Medical Corporation

Telephone: 508-553-8850

 

Sontra Reports Fourth Quarter 2002 Financial Results and Product Development Update

 

Franklin, Mass.—March 31, 2003—Sontra Medical Corporation (Nasdaq SC: SONT) announced today financial results for the fourth quarter and fiscal year ended December 31, 2002.

 

For the three months ended December 31, 2002, the net loss applicable to common shareholders was $1,408,000, or $.15 per share, compared to a loss of $901,000, or $.35 per share, in the same period in 2001. For the year ended December 31, 2002, the net loss applicable to common shareholders was $4,304,000, or $.70 per share, compared to a loss of $4,936,000, or $2.12 per share, in the same period in 2001. The Company had $2,231,000 in cash and cash equivalents as of December 30, 2002 with no outstanding debt. As described in more detail in the Company’s most recent Annual Report on Form 10-KSB, filed today with the SEC, based on the Company’s current operating plan, its cash on hand at December 31, 2002 is expected to last only until June 30 2003. In their report on the Company’s audited consolidated financial statements for the fiscal year ended December 31, 2002, the Company’s auditors have expressed substantial doubt about the Company’s ability to continue as a going concern. The Company is actively seeking to procure additional financing to fund its ongoing operations.

 

Product Development Update

Symphony Diabetes Management System

 

“During 2002 we made excellent progress furthering the development of our Symphony Diabetes Management System for the continuous non-invasive monitoring of glucose levels in diabetic patients,” stated Thomas W. Davison, the Company’s President and Chief Executive Officer. “We have completed the development of beta versions of our SonoPrep® hand-held ultrasonic skin permeation device for the Symphony system that we expect to be used by clinicians in our upcoming human clinical trials. In addition, we also completed the development of alpha versions of our glucose biosensor and meter which comprise the other key components of the Symphony system. The Sonoprep® device is used to make the skin more permeable and facilitates the continuous flow of glucose into the biosensor applied to the skin which continuously transmits glucose readings once every second to the glucose meter. We expect to complete a Phase 1 human clinical study of the Symphony system in the second quarter of 2003. This study should provide clinical validation for our technology and will allow us to make further improvements to the system. We are excited about the market opportunity for Symphony because we believe that it addresses an unmet market need for a truly continuous and non-invasive glucose monitor in the rapidly growing home glucose testing market.”

 

Transdermal Drug Delivery

 

An application of SonoPrep increases skin permeability 100 times greater than untreated skin, thereby making it possible to deliver large molecule drug transdermally. In addition, the SonoPrep device can significantly accelerate the onset time of action for existing transdermal and topically applied drugs existing drugs, thereby expanding their clinical indications. Sontra completed a forty –two (42) patient clinical study which demonstrated that SonoPrep accelerated the onset of action of a topically applied anesthetic from one hour to five minutes. The Company is actively working to obtain 510(k) marketing clearance


 

from the Food and Drug Administration (“FDA”) in 2003 for the use of SonoPrep to enhance the delivery of a topical anesthetic. If obtained, the Company would expect to commercially launch a product for this application in 2004.

 

Electrophysiology testing

 

The SonoPrep device consistently reduces skin impedance to less than 1,000 ohms and thus greatly improves electrical signals obtained from electrophysiology tests. During 2003, Sontra hopes to receive 510(k) marketing clearance from the FDA for the use of SonoPrep in electrophysiology applications and expects to commercially launch a product for this application in 2004.

 

About Sontra Medical Corporation (www.sontra.com)

 

Sontra Medical Corporation (Nasdaq SmallCap: SONT) is the pioneer of SonoPrep® technology, a non-invasive ultrasound-mediated skin permeation technology for medical and therapeutic applications including transdermal diagnostics and the enhanced delivery of drugs through the skin. Sontra’s lead product in development is its Symphony Diabetes Management System for the continuous non-invasive monitoring of glucose levels in diabetic patients. Other product development programs based on the SonoPrep skin permeation technology include skin preparation to improve electrophysiology tests, the enhanced transdermal delivery of topically applied drugs and delivery of large molecule injectable biopharmaceuticals.

 

This press release contains “forward-looking statements” intended to qualify for the safe-harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements are neither promises nor guarantees, but involve risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements. In particular, such risks and uncertainties include, among others, the Company’s history of losses and its current cash position, the Company’s ability to procure financing necessary to continue as a going concern, the Company’s ability to comply with Nasdaq’s listing standards, the Company’s limited operating history, the Company’s dependence upon successful collaborations with strategic partners, enforcement and protection of the Company’s intellectual property rights and those of its licensors, the Company’s limited manufacturing experience, increased competition with its products, product liability risks, the Company’s early stage of development, the Company’s dependence on key personnel, uncertainty of product development efforts, and risks associated with the product regulatory approval processes. Further information on risks and other factors that may cause actual results and performance to differ materially from those indicated can be found in the Company’s Annual Report on Form 10-KSB for the fiscal year ended December 31, 2002, filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2003, and in the Company’s other periodic and current reports filed with the SEC, including Company’s quarterly report on Form 10-QSB for the period ended September 30, 2002. Copies of such documents may be obtained by contacting the Company or the SEC. The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in its expectations or events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.


 

Sontra Medical Corporation

 

(A Development Stage Company)

 

Consolidated Statements of Loss

 

    

For the Years Ended

    

Three Months Ended

(Unaudited)

 
    

December 31,

    

December 31,

    

December 31,

 
    

2002


    

2001


    

2002


    

2001


 

Revenue

  

$

—  

 

  

$

—  

 

  

$

—  

 

  

$

—  

 

Operating Expenses:

                                   

Research and development

  

 

1,984,802

 

  

 

2,107,146

 

  

 

584,717

 

  

 

585,288

 

General and administrative

  

 

2,205,732

 

  

 

1,397,947

 

  

 

834,858

 

  

 

312,296

 

    


  


  


  


Total operating expenses

  

 

4,190,534

 

  

 

3,505,093

 

  

 

1,419,575

 

  

 

897,584

 

    


  


  


  


Loss from operations

  

 

(4,190,534

)

  

 

(3,505,093

)

  

 

(1,419,575

)

  

 

(897,584

)

Interest income(expense), net

  

 

34,224

 

  

 

(1,220,293

)

  

 

11,208

 

  

 

62,659

 

    


  


  


  


Net loss

  

 

(4,156,310

)

  

 

(4,725,386

)

  

 

(1,408,367

)

  

 

(834,925

)

Accretion of Series B Redeemable Convertible Preferred Stock

  

 

(148,101

)

  

 

(210,501

)

  

 

—  

 

  

 

(66,542

)

    


  


  


  


Net loss applicable to common shareholders

  

$

(4,304,411

)

  

$

(4,935,887

)

  

$

(1,408,367

)

  

$

(901,467

)

    


  


  


  


Net loss per common, basic and diluted

  

$

(0.70

)

  

$

(2.12

)

  

$

(0.15

)

  

$

(0.35

)

    


  


  


  


Basic and diluted weighted average common shares outstanding

  

 

6,163,432

 

  

 

2,323,769

 

  

 

9,325,733

 

  

 

2,612,819

 

    


  


  


  



 

Sontra Medical Corporation

 

(A Development Stage Company)

 

Consolidated Balance Sheets

 

    

As of December 31,

 
    

2002


    

2001


 

ASSETS:

                 

Current Assets:

                 

Cash and cash equivalents

  

$

2,231,104

 

  

$

381,067

 

Prepaid expenses and other current assets

  

 

138,454

 

  

 

52,054

 

    


  


Total current assets

  

 

2,369,558

 

  

 

433,121

 

    


  


Property and Equipment, at cost

                 

Computer equipment

  

 

154,479

 

  

 

87,663

 

Office and laboratory equipment

  

 

383,807

 

  

 

394,696

 

Furniture and fixtures

  

 

14,071

 

  

 

9,139

 

Leasehold improvements

  

 

287,035

 

  

 

287,035

 

    


  


    

 

839,392

 

  

 

778,533

 

Less-accumulated depreciation and amortization

  

 

(644,055

)

  

 

(507,616

)

    


  


Net property and equipment

  

 

195,337

 

  

 

270,917

 

    


  


Restricted cash

  

 

100,000

 

  

 

10,500

 

Other assets

  

 

31,675

 

  

 

31,675

 

    


  


Total assets

  

$

2,696,570

 

  

$

746,213

 

    


  


LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT)

Current Liabilities:

                 

Accounts payable

  

$

169,368

 

  

$

164,599

 

Accrued expenses

  

 

554,217

 

  

 

208,181

 

    


  


Total current liabilities

  

 

723,585

 

  

 

372,780

 

    


  


Commitments

                 

Series A Convertible Preferred Stock, $0.01 par value Authorized 1,938,075 shares, issued and outstanding no shares in 2002 and 1,938,075 shares in 2001 (liquidation preference of $7,000,000)

  

 

—  

 

  

 

7,000,000

 

    


  


Series B Redeemable Convertible Preferred Stock, $0.01 par value Authorized 3,994,514 shares, issued and outstanding no shares in 2002 and 1,263,481 shares in 2001 at redemption value (liquidation preference of $3,420,789 at 2001)

  

 

—  

 

  

 

3,420,789

 

    


  


Stockholders' Equity (Deficit):

                 

Common stock, $0.01 par value, Authorized 20,000,000 shares issued and outstanding 9,355,880 shares in 2002 and 2,612,819 in 2001

  

 

93,559

 

  

 

26,128

 

Additional paid-in capital

  

 

19,473,410

 

  

 

1,330,425

 

Deferred stock-based compensation

  

 

(2,033,765

)

  

 

—  

 

Subscriptions receivable

  

 

(17,294

)

  

 

(17,294

)

Deficit accumulated during the development stage

  

 

(15,542,925

)

  

 

(11,386,615

)

    


  


Total stockholders' equity (deficit)

  

 

1,972,985

 

  

 

(10,047,356

)

    


  


Total liabilities, convertible preferred stock and stockholders' equity (deficit)

  

$

2,696,570

 

  

$

746,213

 

    


  


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