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): November 14, 2005

SONTRA MEDICAL CORPORATION

(Exact Name of Registrant as Specified in its Charter)

Minnesota	000-23017	41-1649949
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer 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:

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

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

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

¨ 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 November 14, 2005, Sontra Medical Corporation (the “Registrant”) issued a press release regarding its financial results for its fiscal third quarter ended September 30, 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 November 14, 2005.

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
Date: November 15, 2005	By:	/S/    SEAN F. MORAN
		Sean F. Moran Chief Financial Officer

EXHIBIT INDEX

Exhibit No.	Description
99.1	Press Release of the Registrant, dated November 14, 2005.

EX-99.1

EXHIBIT 99.1

Sontra Medical Corporation Reports Third Quarter 2005 Results and Business Update

Franklin, MA — November 14, 2005 — Sontra Medical Corporation (NASDAQ: SONT) announced financial results today for the three and nine months ended September 30, 2005. For the three months ended September 30, 2005, the net loss applicable to common stockholders was $1,511,000, or $.07 per share, as compared to $1,302,000, or $.07 per share, for the same period in 2004. For the nine months ended September 30, 2005, the net loss applicable to common stockholders was $4,556,000, or $.21 per share, as compared to $4,112,000, or $.26 per share, for the same period in 2004. The Company ended the quarter with $5,282,000 in cash and short-term investments on hand and expects that these funds will be sufficient to fund operations through at least June 2006.

Third Quarter Product Highlights:

Continuous Transdermal Glucose Monitoring System

• Designed clinical protocols for hospital intensive care unit (ICU) product; human trials to commence in 2006.

• Fabricated prototypes of new telemetry-based glucose flux biosensor and wireless meter; patients with diabetes to be tested in early 2006.

• Completed ISO audit and recommended for ISO 13485 certification; planning to achieve European CE mark approval for SonoPrep^® skin permeation device in 2006.

Transdermal Vaccination Facilitated by SonoPrep^®

• Forged research partnership with EpiVax and commenced pre-clinical studies using SonoPrep skin permeation device to deliver EpiVax’s HIV vaccine.

• Awarded grant from U.S. Army to investigate the use of SonoPrep to deliver the dengue vaccine transdermally.

SonoPrep^® and Procedure Tray for Topical Lidocaine

• Launched product to pediatric offices.

• Product evaluations continuing at large pediatric hospitals.

• Results from Hasbro pediatric clinical study accepted for publication in the Pediatric Emergency Care journal.

Sontra is continuing to negotiate the terms of an agreement with Bayer HealthCare LLC’s Diabetes Care Division related to the continued development of a continuous non-invasive glucose monitoring system. Such agreement is expected to revise and define product development activities, deliverables, milestones and payments, including the $3 million milestone payment upon completion of Phase 1 of Bayer’s development process. The Company expects to execute this agreement during the fourth quarter of fiscal 2005 and will make an announcement and conduct a conference call at that time.

“We are very pleased with the progress we have made in the development of our continuous transdermal glucose monitor for the hospital ICU market,” stated Thomas W. Davison, PhD, Sontra’s President and Chief Executive Officer. “We have completed the fabrication of our first prototypes so that validation clinical studies in critical care can commence in 2006. Frequent glucose monitoring and intensive insulin therapy have become a standard of care in critical care medicine, as tight glucose control has been shown to significantly reduce patient mortality, complications, hospital stay and cost. As a result, intensive care nurses are measuring blood glucose for their patients up to every hour in order to adjust insulin infusion rates. Development of our critical care glucose monitor is proceeding in parallel with the development of a product for the $5 billion diabetes home testing market, as the product technologies are the same and designs are very similar.”

Dr. Davison continued, “In transdermal vaccination, the knowledge we gained in our recently completed studies with the influenza and Hepatitis A vaccines is helping us optimize the formulation and delivery of vaccines through ultrasonically permeated skin. We recently developed research partnerships with EpiVax and the U.S. Army, and we expect to enter into future R&D research partnerships to incorporate SonoPrep technology into the development of novel therapeutic and prophylactic vaccines.”

Dr. Davison concluded, “The selling effort and sales cycle required for adoption of SonoPrep and procedure trays for topical lidocaine anesthesia in pediatric hospitals are more extensive than our original expectations. Nevertheless, utilization at adopting hospitals is encouraging. While we avoided significant selling costs by entering this market through independent distributors, we learned that successful evaluations require a concerted direct sales effort. We are currently reevaluating our distribution strategy and are exploring alternative sales and marketing methods.”

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 has demonstrated strong results from its initial human clinical trials at leading universities and medical centers for several billion dollar market opportunities, including the transdermal delivery of vaccines and large molecule drugs and continuous non-invasive glucose monitoring. 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, Chief Financial Officer

508-530-0334

^© 2005 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 benefits and efficacy of the SonoPrep device in connection with diagnostics, vaccine delivery, glucose monitoring and transdermal drug delivery, the expected timing, terms and benefits of the development agreement with Bayer, the expected market opportunities, clinical study and product evaluation results, distribution and market acceptance of the SonoPrep device and technology, the expected size of the markets for the SonoPrep device and technology, Sontra’s expected ability to form strategic partnerships and commercialize additional products, including for the hospital intensive care unit and for vaccine delivery, the expected benefits of our current and expected strategic partnerships, 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 collaborations, product development, clinical trials, product evaluations, commercialization efforts, product distribution and market acceptance; the SonoPrep device may not prove effective in connection with diagnostics, vaccine delivery, glucose monitoring and/or transdermal drug delivery; 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; difficulties or delays in obtaining regulatory approvals to market products resulting from development efforts; difficulties or delays associated with sources of regulatory-approved transdermal drugs and vaccines; failure to obtain and maintain patent protection for discoveries; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic partners and third-party distributors to develop, commercialize, market and sell products based on our work; and the requirement for substantial 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 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)

	Three Months Ended September 30,						Nine Months Ended September 30,
	2005			2004			2005			2004
Product revenue	$	20,615		$	12,254		$	169,018		$	14,754
Cost of product revenue		149,209			5,523			246,068			6,324
Gross (loss) profit		(128,594	)		6,731			(77,050	)		8,430
Operating Expenses:
Research and development		998,026			726,261			2,943,821			2,064,785
Selling, general and administrative		427,564			598,265			1,681,341			1,691,961
Total operating expenses		1,425,590			1,324,526			4,625,162			3,756,746
Loss from operations		(1,554,184	)		(1,317,795	)		(4,702,212	)		(3,748,316	)
Interest income		50,670			17,503			163,151			49,260
Interest expense		(5,804	)		—			(12,809	)		—
Net loss		(1,509,318	)		(1,300,292	)		(4,551,870	)		(3,699,056	)
Accretion of dividend and beneficial conversion feature on Series A Convertible Preferred Stock		(1,479	)		(1,479	)		(4,389	)		(412,452	)
Net loss applicable to common stockholders	$	(1,510,797	)	$	(1,301,771	)	$	(4,556,259	)	$	(4,111,508	)
Net loss per common share, basic and diluted	$	(0.07	)	$	(0.07	)	$	(0.21	)	$	(0.26	)
Basic and diluted weighted average common shares outstanding		22,233,964			18,339,560			22,186,347			15,741,981

SONTRA MEDICAL CORPORATION

Consolidated Balance Sheets

	As of
	September 30,			December 31,
	2005			2004
	(Unaudited)
ASSETS
Current Assets:
Cash and cash equivalents	$	781,747		$	2,565,244
Short term investments		4,500,000			6,950,000
Accounts receivable		4,887			16,821
Legal settlement receivable		—			250,000
Inventory, net of reserve for obsolescence		59,408			152,642
Prepaid expenses and other current assets		91,693			69,492
Total current assets		5,437,735			10,004,199
Property and Equipment, at cost
Computer equipment		241,323			206,970
Office and laboratory equipment		593,576			492,377
Furniture and fixtures		14,288			14,288
Manufacturing equipment		197,888			182,210
Leasehold improvements		177,768			174,698
		1,224,843			1,070,543
Less-Accumulated depreciation and amortization		(861,617	)		(655,242	)
Net property and equipment		363,226			415,301
Other Assets:
Restricted cash		29,248			38,997
Other assets		149,741			2,000
Total Other Assets		178,989			40,997
Total assets	$	5,979,950		$	10,460,497
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable	$	227,406		$	358,530
Current portion of note payable		56,889			—
Accrued expenses		388,651			759,051
Total current liabilities		672,946			1,117,581
Note payable, net of current portion		158,375			—
Commitments
Stockholders’ Equity:
Series A Convertible Preferred Stock, $0.01 par value, authorized 7,000,000 shares, issued and outstanding 73,334 shares at September 30, 2005 and December 31, 2004 (preference in liquidation of $74,813)		74,813			76,291
Common stock, $0.01 par value, authorized 60,000,000 shares, issued and outstanding 22,243,674 shares at September 30, 2005 and 21,935,732 shares at December 31, 2004		222,437			219,358
Additional paid-in capital		32,827,532			32,674,740
Deferred stock-based compensation		(41,722	)		(244,912	)
Accumulated deficit		(27,934,431	)		(23,382,561	)
Total stockholders’ equity		5,148,629			9,342,916
Total liabilities and stockholders’ equity	$	5,979,950		$	10,460,497