-----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, Lj0D99TnTjm5ZNNX/Xll15iIjLaDGXPQIpGTaOU3gnQd9Phf1FZH2HCK0kY62M1b PesxKW880kdYP6ejsfMYng== 0001239724-06-000021.txt : 20060316 0001239724-06-000021.hdr.sgml : 20060316 20060316094916 ACCESSION NUMBER: 0001239724-06-000021 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20060316 ITEM INFORMATION: Results of Operations and Financial Condition FILED AS OF DATE: 20060316 DATE AS OF CHANGE: 20060316 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: 06690187 BUSINESS ADDRESS: STREET 1: 10 FORGE PARKWAY CITY: FRANKLIN STATE: MA ZIP: 02038 BUSINESS PHONE: 508 553-8850 MAIL ADDRESS: STREET 1: 10 FORGE PARKWAY CITY: FRANKLIN STATE: MA ZIP: 02038 FORMER COMPANY: FORMER CONFORMED NAME: CHOICETEL COMMUNICATIONS INC/MN/ DATE OF NAME CHANGE: 20020701 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: 19970625 8-K 1 body_form8k.htm FORM 8-K Form 8-K

UNITED STATES
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 16, 2006

SONTRA MEDICAL CORPORATION

(Exact Name of Registrant as Specified in its Charter)


Minnesota   000-23017    41-1649949
(State or Other Jurisdiction  (Commission File Number)   (IRS Employer
   of Incorporation)     Identification No.)

10 Forge Parkway
Franklin, Massachusetts 02038
(Address of Principal Executive Offices) (Zip Code)

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

Not Applicable
(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 
 

 

Item 2.02 Results of Operations and Financial Condition.

On March 16, 2006, Sontra Medical Corporation (the “Registrant”) issued a press release regarding its financial results for its fiscal fourth quarter and fiscal year ended December 31, 2005. A copy of the press release issued by the Registrant is furnished herewith as Exhibit 99.1 and is incorporated herein by reference.
 
The information contained herein and in the accompanying exhibit shall not 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, unless expressly incorporated by specific reference to such filing. The information in this report, including the exhibit hereto, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended.

Item 9.01 Financial Statements and Exhibits.

(d)  
Exhibits

The following exhibit is furnished with this Form 8-K:

99.1  
Press Release of the Registrant, dated March 16, 2006.

 
 
 


 
 

 

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

By: /s/ Sean F. Moran
Date: March 16, 2006     Sean F. Moran
Chief Financial Officer






 
 

 

EXHIBIT INDEX

Exhibit No.  Description
 
99.1  
Press Release of the Registrant, dated March 16, 2006.



EX-99.1 2 ex99_1.htm EXHIBIT 99.1-PRESS RELEASE DATED MARCH 16, 2006 Exhibit 99.1-Press Release dated March 16, 2006
 
FOR IMMEDIATE RELEASE
 
Sontra Medical Reports Fourth Quarter and Fiscal Year 2005 Results and Business Update

Franklin, MA - March 16, 2006 -- Sontra Medical Corporation (NASDAQ: SONT) announced today financial results for the fourth quarter and fiscal year ended December 31, 2005. For the three months ended December 31, 2005, the net loss applicable to common stockholders was $1,187,000, or $.05 per share, as compared to $1,663,000 or $.08 per share, for the same period in 2004. For the year ended December 31, 2005, the net loss applicable to common stockholders was $5,743,000, or $.26 per share, as compared to $5,774,000, or $.34 per share, in 2004. The Company ended the year with a total of $4,017,000 in cash and short term investments. On March 7, 2006, the Company completed an equity financing that raised $1.6 million. The Company expects that its cash on hand at December 31, 2005, combined with proceeds from the financing completed in March 2006, will be sufficient to fund operations through at least January 2007.
 
Recent Product Highlights:

Continuous Transdermal Glucose Monitoring System
·  
Optimizing performance of telemetry-based glucose flux biosensor and wireless meter.
·  
Designed clinical protocols for hospital intensive care unit (ICU) product; human trials to commence in April 2006.
·  
Developing portable, low cost 3rd Generation SonoPrep® skin permeation device for diabetes home testing market.
·  
Achieved ISO 13485 Quality Management System certification for SonoPrep.
 
SonoPrep and Procedure Tray for Topical Lidocaine
·  
Developed low cost topical lidocaine gel for use with SonoPrep procedure tray.
·  
Introduced Generation 1.75 SonoPrep skin permeation device.
·  
Completed 2nd Generation SonoPrep device; commercial launch scheduled for April 2006.

Other SonoPrep Product Applications
·  
Formed research alliance with HortResearch for evaluating SonoPrep in sports performance monitoring applications.
·  
Awarded research grant from U.S Army for SonoPrep enabled transdermal delivery of dengue vaccine.
 
“We have focused a majority of our resources on optimizing the performance of our continuous transdermal glucose monitor for the hospital ICU market,” stated Thomas W. Davison, PhD, Sontra’s President and Chief Executive Officer. “The first fully functional transdermal glucose monitors have been built and are functioning as anticipated in in-house clinical tests that will lead extensive clinical testing in the coming months. We have designed human clinical trials and obtained IRB approvals and expect clinical trials to commence during the second quarter of 2006. Intensive insulin therapy and frequent blood glucose testing to maintain tight glycemic control is one of the most exciting new trends in critical care medicine. The enormous clinical benefits include reducing mortality and severe complications by up to 50%. These benefits, combined with significant cost savings that come from reduced length of stay and less intervention, are expected to create a new market for critical care continuous glucose monitors that we estimate will exceed $1 billion.”
 
Conference Call Information
 
Sontra will host a live conference call and listen-only Webcast on Thursday, March 16, 2006 at 11 a.m. ET to provide a business update and discuss its fourth quarter and fiscal year 2005 financial results.
 
To participate in the conference call, please dial: 1-973-409-9259.
 
A listen-only Webcast and replay of the conference call are available at www.sontra.com
 


About Sontra Medical Corporation (www.sontra.com)
 
Sontra Medical Corporation is a technology leader in transdermal science. Sontra’s SonoPrep ultrasound-mediated skin permeation technology combined with technical competencies in transdermal drug formulation, delivery systems and biosensors is creating a new paradigm in transdermal drug delivery and diagnosis. The SonoPrep technology is being developed for several billion dollar market opportunities, including continuous glucose monitoring and the transdermal delivery of large molecule drugs and vaccines. Sontra is currently marketing the SonoPrep device and procedure tray for use with topical lidocaine to achieve rapid (within five minutes) skin anesthesia.
 
Investor Relations Contact:
Sean Moran, Sontra Medical CFO
508-530-0334

© 2006 Sontra Medical Corporation. 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 technological advances and availability of the second-generation SonoPrep device, the expected benefits and efficacy of the SonoPrep device in connection with diagnostics, vaccine delivery, glucose monitoring and transdermal drug delivery, Sontra’s expected ability to develop, market and sell products based on its technology, including a continuous transdermal glucose monitor for the hospital ICU market; the expected market opportunities, distribution and market acceptance of the SonoPrep device and technology, the expected size of the market for the continuous transdermal glucose monitor for the hospital ICU; and Sontra’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. 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: our technology is new and we may experience adverse results in research and development efforts, product development, clinical trials, product evaluations, commercialization efforts, product distribution and market acceptance; markets for our products may develop slower than expected, or not at all; our sales cycle is lengthy and we are still developing sales and marketing strategies which may or may not prove effective; the SonoPrep device may not prove effective in connection with diagnostics, vaccine delivery, glucose monitoring and/or transdermal drug delivery; we may experience difficulties or delays in obtaining regulatory approvals to market products resulting from development efforts or difficulties or delays associated with sources of regulatory-approved transdermal drugs and vaccines; failure to obtain and maintain patent protection for discoveries or commercial limitations imposed by patents owned or controlled by third parties would have an adverse effect on us; we depend upon strategic partners and third-party distributors to develop, commercialize, market and sell products based on our work; and we require substantial additional funding to conduct research and development and to expand commercialization, distribution and marketing activities. 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 Annual Report on Form 10-KSB. 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
                   
                   
   
For the Years Ended
 
For the Three Months Ended
 
   
December 31,
 
December 31,
 
   
2005
 
2004
 
2005
 
2004
 
Revenue:
                         
Product revenue
 
$
170,660
 
$
33,565
 
$
1,642
 
$
18,811
 
Licensing revenue
   
5,000
   
-
   
5,000
   
-
 
Total revenue
   
175,660
   
33,565
   
6,642
   
18,811
 
                           
Cost of product revenue
   
251,482
   
16,680
   
5,414
   
10,356
 
Gross (loss) profit
   
(75,822
)
 
16,885
   
1,228
   
8,455
 
                           
Operating Expenses:
                         
Research and development
   
3,794,888
   
3,039,450
   
851,067
   
974,665
 
Selling, general and administrative
   
2,055,833
   
2,423,806
   
374,492
   
731,845
 
Total operating expenses
   
5,850,721
   
5,463,256
   
1,225,559
   
1,706,510
 
                           
Loss from operations
   
(5,926,543
)
 
(5,446,371
)
 
(1,224,331
)
 
(1,698,055
)
                           
Other income (expense), net
                         
Interest income
   
207,699
   
86,189
   
44,548
   
36,929
 
Interest expense
   
(18,292
)
 
-
   
(5,483
)
 
-
 
Other income, net
   
189,407
   
86,189
   
39,065
   
36,929
 
                           
Net loss
   
(5,737,136
)
 
(5,360,182
)
 
(1,185,266
)
 
(1,661,126
)
Accretion of dividend and beneficial conversion feature
                         
     on Series A Convertible Preferred Stock
   
(5,867
)
 
(413,901
)
 
(1,478
)
 
(1,449
)
Net loss applicable to common shareholders
 
$
(5,743,003
)
$
(5,774,083
)
$
(1,186,744
)
$
(1,662,575
)
                           
Net loss per common share, basic and diluted
 
$
(0.26
)
$
(0.34
)
$
(0.05
)
$
(0.08
)
                           
Basic and diluted weighted average common shares outstanding
   
22,205,025
   
16,763,798
   
22,260,449
   
19,840,477
 
 
 
 
 

 
 
 

SONTRA MEDICAL CORPORATION
Consolidated Balance Sheets
           
   
As of December 31,
 
   
2005
 
2004
 
           
ASSETS
             
Current Assets:
             
Cash and cash equivalents
 
$
1,016,792
 
$
2,565,244
 
Short term investments
   
3,000,000
   
6,950,000
 
Accounts receivable
   
1,129
   
16,821
 
Legal settlement receivable
   
-
   
250,000
 
Inventory, net of reserve for obsolescence
   
31,250
   
152,642
 
Prepaid expenses and other current assets
   
65,468
   
69,492
 
Total current assets
   
4,114,639
   
10,004,199
 
               
Property and Equipment, at cost:
             
Computer equipment
   
241,324
   
206,970
 
Office and laboratory equipment
   
593,576
   
492,377
 
Furniture and fixtures
   
14,288
   
14,288
 
Manufacturing equipment
   
224,888
   
182,210
 
Leasehold improvements
   
177,768
   
174,698
 
     
1,251,844
   
1,070,543
 
Less-accumulated depreciation and amortization
   
(894,658
)
 
(655,242
)
Net property and equipment
   
357,186
   
415,301
 
               
Other Assets:
             
Restricted cash
   
29,248
   
38,997
 
Deposits and other assets
   
207,012
   
2,000
 
Total other assets
   
236,260
   
40,997
 
               
Total assets
 
$
4,708,085
 
$
10,460,497
 
               
LIABILITIES AND STOCKHOLDERS' EQUITY
             
               
Current Liabilities:
             
Accounts payable
 
$
210,208
 
$
358,530
 
Deferred revenue
   
45,000
   
-
 
Current portion of note payable
   
53,653
   
-
 
Accrued expenses
   
416,936
   
759,051
 
Total current liabilities
   
725,797
   
1,117,581
 
               
Note Payable, net of current portion
   
149,043
   
-
 
               
Commitments
             
               
Stockholders' Equity:
             
Series A Convertible Preferred Stock, $0.01 par value, authorized 7,000,000 shares,
             
issued and outstanding 73,334 shares at December 31, 2005 and 2004
             
(preference in liquidation of $76,291)
   
76,291
   
76,291
 
Common stock, $0.01 par value, authorized 60,000,000 shares, issued and outstanding
             
22,261,830 shares at December 31, 2005 and 21,935,732 shares at December 31, 2004
   
222,618
   
219,358
 
Additional paid-in capital
   
32,658,192
   
32,674,740
 
Deferred stock-based compensation
   
(4,159
)
 
(244,912
)
Accumulated deficit
   
(29,119,697
)
 
(23,382,561
)
Total stockholders' equity
   
3,833,245
   
9,342,916
 
               
Total liabilities and stockholders' equity
 
$
4,708,085
 
$
10,460,497
 
 
 

 

-----END PRIVACY-ENHANCED MESSAGE-----