##### Table of Contents

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549



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FORM 10-QSB



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QUARTERLY REPORT UNDER SECTION 13 OR
15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934



For the quarterly period ended September 30, 2004



Commission File Number: 000-23017



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SONTRA MEDICAL CORPORATION

(Exact name of small business issuer as specified in its charter)



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|                                                               |  |                                        
|-------------------------------------------------------------- |  | ---------------------------------------
|MINNESOTA                                                      |  | 41-1649949                             
|(State or other jurisdiction of incorporation or organization) |  | (I.R.S. Employer Identification Number)



|                                         |  |           
|---------------------------------------- |  | ----------
|10 Forge Parkway, Franklin, MA           |  | 02038     
|(Address of principal executive offices) |  | (Zip Code)



(508) 553-8850

(Issuers telephone number, including area code)



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Check whether the issuer (1) filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the past 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 ̈



As of November 5, 2004, the Registrant had 19,197,644 shares of Common Stock outstanding.



Transitional Small Business Disclosure Format (Check
one):    Yes ̈No  x



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##### Table of Contents

FORM 10-QSB INDEX



|                               |  |                                                                                                                   |  |           
|------------------------------ |  | ----------------------------------------------------------------------------------------------------------------- |  | ----------
|                               |  |                                                                                                                   |  | PageNumber
|Part I - Financial Information |  |                                                                                                                  
|                               |  |                                                                                                                  
|Item 1.                        |  | Consolidated Financial Statements                                                                                 |  |           
|                               |  |                                                                                                                  
|                               |  | Consolidated Balance Sheets as of September 30, 2004 (Unaudited) and December 31, 2003                            |  | 3         
|                               |  |                                                                                                                  
|                               |  | Consolidated Statements of Operations for the three and nine months ended September 30, 2004 and 2003 (Unaudited) |  | 4         
|                               |  |                                                                                                                  
|                               |  | Consolidated Statements of Cash Flows for the three and nine months ended September 30, 2004 and 2003 (Unaudited) |  | 5         
|                               |  |                                                                                                                  
|                               |  | Notes to Consolidated Financial Statements (Unaudited)                                                            |  | 6         
|                               |  |                                                                                                                  
|Item 2.                        |  | Managements Discussion and Analysis or Plan of Operation                                                         |  | 11        
|                               |  |                                                                                                                  
|Item 3.                        |  | Controls and Procedures                                                                                           |  | 18        
|                               | 
|Part II - Other Information    |  |                                                                                                                  
|                               |  |                                                                                                                  
|Item 2.                        |  | Unregistered Sales of Equity Securities and Use of Proceeds                                                       |  | 19        
|                               |  |                                                                                                                  
|Item 5.                        |  | Other Information                                                                                                 |  | 19        
|                               |  |                                                                                                                  
|Item 6.                        |  | Exhibits                                                                                                          |  | 19        
|                               |  |                                                                                                                  
|                               |  | Signatures                                                                                                        |  | 20        



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##### Table of Contents

SONTRA MEDICAL CORPORATION

Consolidated Balance Sheets



|                                                                                                                                                                                                                                |  |                    |             |   |                   |   |             |  
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |  | ------------------ | ----------- | - | ----------------- | - | ----------- | -
|                                                                                                                                                                                                                                |  | As of              |            
|                                                                                                                                                                                                                                |  | September 30, 2004 |             |   | December 31, 2003 |  
|                                                                                                                                                                                                                                |  |                   
|                                                                                                                                                                                                                                |  | (Unaudited)        |             |   |                   |  
|ASSETS                                                                                                                                                                                                                          |  |                    |             |   |                   |   |             |  
|Current Assets:                                                                                                                                                                                                                 |  |                    |             |   |                   |   |             |  
|Cash and cash equivalents                                                                                                                                                                                                       |  | $                  | 6,273,632   |   |                   | $ | 4,868,933   |  
|Accounts receivable                                                                                                                                                                                                             |  |                    | 12,254      |   |                   |   | 1,500,000   |  
|Inventory                                                                                                                                                                                                                       |  |                    | 18,849      |   |                   |   |            |  
|Prepaid expenses and other current assets                                                                                                                                                                                       |  |                    | 56,441      |   |                   |   | 66,075      |  
|                                                                                                                                                                                                                                |  |                    |             |   |                   |   |             |  
|Total current assets                                                                                                                                                                                                            |  |                    | 6,361,176   |   |                   |   | 6,435,008   |  
|                                                                                                                                                                                                                                |  |                    |             |   |                   |   |             |  
|Property and Equipment, at cost                                                                                                                                                                                                 |  |                    |             |   |                   |   |             |  
|Computer equipment                                                                                                                                                                                                              |  |                    | 207,842     |   |                   |   | 171,272     |  
|Office and laboratory equipment                                                                                                                                                                                                 |  |                    | 483,291     |   |                   |   | 405,285     |  
|Furniture and fixtures                                                                                                                                                                                                          |  |                    | 14,288      |   |                   |   | 14,288      |  
|Manufacturing equipment                                                                                                                                                                                                         |  |                    | 182,210     |   |                   |   | 144,695     |  
|Leasehold improvements                                                                                                                                                                                                          |  |                    | 174,698     |   |                   |   | 166,289     |  
|                                                                                                                                                                                                                                |  |                    |             |   |                   |   |             |  
|                                                                                                                                                                                                                                |  |                    | 1,062,329   |   |                   |   | 901,829     |  
|Less-Accumulated depreciation and amortization                                                                                                                                                                                  |  |                    | (615,240    | ) |                   |   | (498,341    | )
|                                                                                                                                                                                                                                |  |                    |             |   |                   |   |             |  
|Net property and equipment                                                                                                                                                                                                      |  |                    | 447,089     |   |                   |   | 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                                                                                                                                                                                                                    |  | $                  | 6,859,011   |   |                   | $ | 6,889,242   |  
|                                                                                                                                                                                                                                |  |                    |             |   |                   |   |             |  
|LIABILITIES AND STOCKHOLDERS EQUITY                                                                                                                                                                                            |  |                    |             |   |                   |   |             |  
|Current Liabilities:                                                                                                                                                                                                            |  |                    |             |   |                   |   |             |  
|Accounts payable                                                                                                                                                                                                                |  | $                  | 177,121     |   |                   | $ | 136,810     |  
|Accrued expenses                                                                                                                                                                                                                |  |                    | 352,234     |   |                   |   | 465,092     |  
|                                                                                                                                                                                                                                |  |                    |             |   |                   |   |             |  
|Total current liabilities                                                                                                                                                                                                       |  |                    | 529,355     |   |                   |   | 601,902     |  
|                                                                                                                                                                                                                                |  |                    |             |   |                   |   |             |  
|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, 2004
and 6,495,000 shares at December 31, 2003 (preference in liquidation of $79,296) |  |                    | 79,296      |   |                   |   | 6,628,842   |  
|Common stock, $0.01 par value, authorized 40,000,000 shares, issued and outstanding 19,164,423 shares at September 30, 2004 and 10,102,992
shares at December 31, 2003                                                          |  |                    | 191,644     |   |                   |   | 101,030     |  
|Additional paid-in capital                                                                                                                                                                                                      |  |                    | 28,134,533  |   |                   |   | 17,952,721  |  
|Deferred stock-based compensation                                                                                                                                                                                               |  |                    | (354,382    | ) |                   |   | (372,874    | )
|Accumulated deficit                                                                                                                                                                                                             |  |                    | (21,721,435 | ) |                   |   | (18,022,379 | )
|                                                                                                                                                                                                                                |  |                    |             |   |                   |   |             |  
|Total stockholders equity                                                                                                                                                                                                      |  |                    | 6,329,656   |   |                   |   | 6,287,340   |  
|                                                                                                                                                                                                                                |  |                    |             |   |                   |   |             |  
|Total liabilities and stockholders equity                                                                                                                                                                                      |  | $                  | 6,859,011   |   |                   | $ | 6,889,242   |  
|                                                                                                                                                                                                                                |  |                    |             |   |                   |   |             |  



The accompanying
notes are an integral part of these consolidated financial statements.



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##### Table of Contents

SONTRA MEDICAL CORPORATION

Consolidated Statements of Operations

(Unaudited)



|                                                                                                |  |                                 |            |   |                                 |   |            |      |  |   |            |   |  |   |            |  
|----------------------------------------------------------------------------------------------- |  | ------------------------------- | ---------- | - | ------------------------------- | - | ---------- | ---- |  | - | ---------- | - |  | - | ---------- | -
|                                                                                                |  | Three Months EndedSeptember 30, |            |   | Nine Months Ended September 30, |  
|                                                                                                |  | 2004                            |            |   | 2003                            |   |            | 2004 |  |   | 2003       |  
|Product revenue                                                                                 |  | $                               | 12,254     |   |                                 | $ |           |      |  | $ | 14,754     |   |  | $ |           |  
|Licensing revenue                                                                               |  |                                 |           |   |                                 |   | 1,500,000  |      |  |   |            |   |  |   | 1,500,000  |  
|                                                                                                |  |                                 |            |   |                                 |   |            |      |  |   |            |   |  |   |            |  
|Total revenue                                                                                   |  |                                 | 12,254     |   |                                 |   | 1,500,000  |      |  |   | 14,754     |   |  |   | 1,500,000  |  
|Cost of product sales                                                                           |  |                                 | 5,523      |   |                                 |   |           |      |  |   | 6,324      |   |  |   |           |  
|                                                                                                |  |                                 |            |   |                                 |   |            |      |  |   |            |   |  |   |            |  
|Gross margin                                                                                    |  |                                 | 6,731      |   |                                 |   | 1,500,000  |      |  |   | 8,430      |   |  |   | 1,500,000  |  
|                                                                                                |  |                                 |            |   |                                 |   |            |      |  |   |            |   |  |   |            |  
|                                                                                                |  |                                 |            |  
|Operating Expenses:                                                                             |  |                                 |            |   |                                 |   |            |      |  |   |            |   |  |   |            |  
|Research and development                                                                        |  |                                 | 726,261    |   |                                 |   | 509,143    |      |  |   | 2,064,785  |   |  |   | 1,482,991  |  
|Selling, general and administrative                                                             |  |                                 | 598,265    |   |                                 |   | 137,705    |      |  |   | 1,691,961  |   |  |   | 1,187,930  |  
|                                                                                                |  |                                 |            |   |                                 |   |            |      |  |   |            |   |  |   |            |  
|Total operating expenses                                                                        |  |                                 | 1,324,526  |   |                                 |   | 646,848    |      |  |   | 3,756,746  |   |  |   | 2,670,921  |  
|                                                                                                |  |                                 |            |   |                                 |   |            |      |  |   |            |   |  |   |            |  
|Income (loss) from operations                                                                   |  |                                 | (1,317,795 | ) |                                 |   | 853,152    |      |  |   | (3,748,316 | ) |  |   | (1,170,921 | )
|                                                                                                |  |                                 |            |  
|Interest income                                                                                 |  |                                 | 17,503     |   |                                 |   | 2,357      |      |  |   | 49,260     |   |  |   | 14,494     |  
|                                                                                                |  |                                 |            |   |                                 |   |            |      |  |   |            |   |  |   |            |  
|Net income (loss)                                                                               |  |                                 | (1,300,292 | ) |                                 |   | 855,509    |      |  |   | (3,699,056 | ) |  |   | (1,156,427 | )
|                                                                                                |  |                                 |            |  
|Accretion of dividend and beneficial conversion feature on Series A Convertible Preferred Stock |  |                                 | (1,479     | ) |                                 |   | (2,206,371 | )    |  |   | (412,452   | ) |  |   | (2,206,371 | )
|                                                                                                |  |                                 |            |   |                                 |   |            |      |  |   |            |   |  |   |            |  
|Net loss applicable to common shareholders                                                      |  | $                               | (1,301,771 | ) |                                 | $ | (1,350,862 | )    |  | $ | (4,111,508 | ) |  | $ | (3,362,798 | )
|                                                                                                |  |                                 |            |   |                                 |   |            |      |  |   |            |   |  |   |            |  
|Net loss per common share, basic and diluted                                                    |  | $                               | (0.07      | ) |                                 | $ | (0.14      | )    |  | $ | (0.26      | ) |  | $ | (0.36      | )
|                                                                                                |  |                                 |            |   |                                 |   |            |      |  |   |            |   |  |   |            |  
|Basic and diluted weighted average common shares outstanding                                    |  |                                 | 18,339,590 |   |                                 |   | 9,411,395  |      |  |   | 15,741,981 |   |  |   | 9,383,232  |  
|                                                                                                |  |                                 |            |   |                                 |   |            |      |  |   |            |   |  |   |            |  



The accompanying
notes are an integral part of these consolidated financial statements.



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##### Table of Contents

SONTRA MEDICAL CORPORATION

Consolidated Statements of Cash Flows

(Unaudited)



|                                                                                    |  |                                 |            |   |      |   |            |  
|----------------------------------------------------------------------------------- |  | ------------------------------- | ---------- | - | ---- | - | ---------- | -
|                                                                                    |  | Nine months ended September 30, |           
|                                                                                    |  | 2004                            |            |   | 2003 |  
|Cash Flows From Operating Activities:                                               |  |                                 |            |   |      |   |            |  
|Net loss                                                                            |  | $                               | (3,699,056 | ) |      | $ | (1,156,427 | )
|Adjustments to reconcile net loss to net cash used in operating activities:         |  |                                 |            |   |      |   |            |  
|Depreciation and amortization                                                       |  |                                 | 116,899    |   |      |   | 117,213    |  
|Gain on sale of equipment                                                           |  |                                 |           |   |      |   | (4,239     | )
|Stock-based compensation                                                            |  |                                 | 291,725    |   |      |   | 30,450     |  
|Stock issued to 401(k) plan                                                         |  |                                 | 206,825    |   |      |   | 31,097     |  
|Write off of subscription receivable                                                |  |                                 |           |   |      |   | 17,293     |  
|Changes in assets and liabilities:                                                  |  |                                 |            |   |      |   |            |  
|Accounts receivable                                                                 |  |                                 | 1,487,746  |   |      |   | (1,500,000 | )
|Inventory                                                                           |  |                                 | (18,849    | ) |      |   |           |  
|Prepaid expenses and other current assets                                           |  |                                 | 9,634      |   |      |   | (31,563    | )
|Accounts payable                                                                    |  |                                 | 40,311     |   |      |   | 118,460    |  
|Accrued expenses                                                                    |  |                                 | (112,858   | ) |      |   | (81,955    | )
|                                                                                    |  |                                 |            |   |      |   |            |  
|Net cash used in operating activities                                               |  |                                 | (1,677,623 | ) |      |   | (2,459,671 | )
|                                                                                    |  |                                 |            |   |      |   |            |  
|Cash Flows from Investing Activities:                                               |  |                                 |            |   |      |   |            |  
|Purchase of property and equipment                                                  |  |                                 | (160,500   | ) |      |   | (219,794   | )
|Sale of fixed assets                                                                |  |                                 |           |   |      |   | 16,300     |  
|Increase in restricted cash                                                         |  |                                 |           |   |      |   | (48,746    | )
|Decrease in other assets                                                            |  |                                 |           |   |      |   | 29,675     |  
|                                                                                    |  |                                 |            |   |      |   |            |  
|Net cash used in investing activities                                               |  |                                 | (160,500   | ) |      |   | (222,565   | )
|                                                                                    |  |                                 |            |   |      |   |            |  
|Cash Flows From Financing Activities:                                               |  |                                 |            |   |      |   |            |  
|Proceeds from the exercise of warrants                                              |  |                                 | 3,085,686  |   |      |   |           |  
|Proceeds from the sale of preferred stock and warrants                              |  |                                 |           |   |      |   | 3,223,958  |  
|Proceeds from the exercise of stock options                                         |  |                                 | 157,136    |   |      |   | 27,609     |  
|                                                                                    |  |                                 |            |   |      |   |            |  
|Net cash provided by financing activities                                           |  |                                 | 3,242,822  |   |      |   | 3,251,567  |  
|                                                                                    |  |                                 |            |   |      |   |            |  
|Net Increase in Cash and Cash Equivalents                                           |  |                                 | 1,404,699  |   |      |   | 569,331    |  
|Cash and Cash Equivalents, beginning of period                                      |  |                                 | 4,868,933  |   |      |   | 2,231,104  |  
|                                                                                    |  |                                 |            |   |      |   |            |  
|Cash and Cash Equivalents, end of period                                            |  | $                               | 6,273,632  |   |      | $ | 2,800,435  |  
|                                                                                    |  |                                 |            |   |      |   |            |  
|Supplemental Disclosure of Non Cash Financing Transactions:                         |  |                                 |            |   |      |   |            |  
|Accretion of dividend on Series A Convertible Preferred Stock                       |  | $                               | 118,403    |   |      | $ | 9,447      |  
|                                                                                    |  |                                 |            |   |      |   |            |  
|Conversion of Series A Convertible Preferred Stock into common stock                |  | $                               | 6,421,666  |   |      | $ |           |  
|                                                                                    |  |                                 |            |   |      |   |            |  
|Common stock issued for dividends on converted Series A Convertible Preferred Stock |  | $                               | 246,283    |   |      | $ |           |  
|                                                                                    |  |                                 |            |   |      |   |            |  



The accompanying
notes are an integral part of these consolidated financial statements.



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##### Table of Contents

SONTRA MEDICAL CORPORATION

Notes to Consolidated Financial Statements

September 30, 2004

(Unaudited)



(1) ORGANIZATION AND BASIS OF PRESENTATION



On June 20, 2002, the Company (previously operating under the name ChoiceTel
Communications, Inc. (ChoiceTel)) consummated a merger with Sontra Medical, Inc. (SMI), pursuant to which SMI merged with and into a wholly owned subsidiary of the Company (the Merger). Subsequent to the
consummation of the Merger, the Company changed its name to Sontra Medical Corporation and began operating in SMIs line of business. For accounting purposes, the Merger was treated as a capital transaction and a recapitalization, whereby the
historical financial statements of SMI became the historical financial statements of the Company. The accounting treatment for the recapitalization is similar to that resulting from a business combination, except that goodwill and other intangible
assets were not recorded.



The condensed consolidated financial
statements included herein have been prepared by the Company, without audit, pursuant to the rules and regulations of the Securities and Exchange Commission (SEC). These consolidated financial statements include the accounts of the
Company and its wholly-owned subsidiary, SMI. All significant inter-company balances and transactions have been eliminated in consolidation. These financial statements should be read in conjunction with the Companys audited financial
statements and related footnotes for the fiscal year ended December 31, 2003, which are included in the Companys Annual Report on Form 10-KSB filed with the SEC on March 16, 2004. In the opinion of the Companys management, the unaudited
condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements and include all adjustments (consisting only of normal recurring accruals) necessary to present fairly the
Companys financial position as of September 30, 2004 and the results of operations and cash flows for the three and nine months ended September 30, 2004 and 2003. Certain information and footnote disclosures normally included in the financial
statements prepared in accordance with generally accepted accounting principles have been condensed or omitted pursuant to the relevant SEC rules and regulations. However, the Company believes that its disclosures are adequate to make the
information presented not misleading. The results of operations for the interim periods are not necessarily indicative of the results of operations for the full fiscal year or any other interim period.



The Company is a medical company engaged in the development of transdermal
diagnostic and drug delivery products based on its SonoPrep®ultrasonic skin permeation
technology. The Company has incurred significant losses from operations since its inception and has primarily funded these losses through issuances of equity and convertible promissory notes.



As of September 30, 2003, the Company recognized $1,500,000 of license
revenue under a license agreement with Bayer Diagnostics Division of Bayer Healthcare LLC entered into on July 28, 2003. As a result, the Company is no longer considered a development stage company for financial reporting purposes.



(2) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES



The accompanying financial statements reflect the application of certain
accounting policies as described in this note and elsewhere in the accompanying financial statements.



(a) Use of Estimates



The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and
disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates. Material estimates that are
particularly susceptible to significant changes in the near term relate to the valuation of inventory and the realizability of deferred tax assets.



(b) Cash and Cash Equivalents



The Company considers all highly liquid investments with maturities of ninety days or less to be cash equivalents. Cash equivalents consist primarily of
auction rate preferred shares and money market funds as of September 30, 2004 and December 31, 2003. Restricted cash at September 30, 2004 and December 31, 2003 represents a deposit on the Companys leased offices.



(c) Accounts Receivable



The Company provides credit terms to customers in connection with purchases of the Companys products. Credit terms,
for approved customers, are generally on a net 30-day basis.



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##### Table of Contents

SONTRA MEDICAL CORPORATION

Notes to Consolidated Financial Statements

September 30, 2004

(Unaudited)



Management periodically reviews customer account activity in order to assess the adequacy of the allowances provided for potential losses. Factors
considered include economic conditions, collateral values and each customers payment history and credit worthiness. Adjustments, if any, are made to reserve balances following the completion of these reviews to reflect managements best
estimate of potential losses.



(d) Inventory



Inventory is valued at the lower of average cost or market on a first-in
first-out (FIFO) method.



(e) Depreciation and Amortization



The Company provides for depreciation and amortization by charges to
operations for the cost of assets using the straight-line method based on the estimated useful lives of the related assets, as follows:



|                                |  |                                                   
|------------------------------- |  | --------------------------------------------------
|Asset Classification            |  | Estimated Useful Life                             
|Computer equipment              |  | 3 years                                           
|Office and laboratory equipment |  | 3-5 years                                         
|Manufacturing equipment         |  | 5 years                                           
|Furniture and fixtures          |  | 7 years                                           
|Leasehold improvements          |  | Shorter of life of lease and estimated useful life



(f) Stock-Based Compensation



Statement of Financial Accounting Standards
(SFAS) No. 123, Accounting for Stock-Based Compensation encourages all entities to adopt a fair value based method of accounting for employee stock compensation plans, whereby compensation cost is measured at the grant date
based on the value of the award and is recognized over the service period, which is usually the vesting period. However, it also allows an entity to continue to measure compensation cost for those plans using the intrinsic value based method of
accounting prescribed by APB Opinion No. 25, Accounting for Stock Issued to Employees, whereby compensation cost is the excess, if any, of the quoted market price of the stock at the grant date (or other measurement date) over the amount
an employee must pay to acquire the stock. Stock options issued under the Companys stock option plans generally have no intrinsic value at the grant date, and under Opinion No. 25 no compensation cost is recognized for them. The Company does
not plan to adopt the fair value accounting model for stock-based employee compensation under SFAS No. 123.



The Company applies Opinion No. 25 and related interpretations in accounting for stock options issued to employees and directors. Had compensation cost
for the Companys stock options issued to employees and directors been determined based on the fair value at the grant dates consistent with SFAS No. 123, the Companys net loss and net loss per share would have been adjusted to the pro
forma amounts as follows:



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##### Table of Contents

SONTRA MEDICAL CORPORATION

Notes to Consolidated Financial Statements

September 30, 2004

(Unaudited)



|                                                                                                   |  |                                  |            |   |                                 |   |            |             |  |   |             |   |  |   |            |  
|-------------------------------------------------------------------------------------------------- |  | -------------------------------- | ---------- | - | ------------------------------- | - | ---------- | ----------- |  | - | ----------- | - |  | - | ---------- | -
|                                                                                                   |  | Three Months Ended September 30, |            |   | Nine Months Ended September 30, |  
|                                                                                                   |  | 2004                             |            |   | 2003                            |   |            | 2004        |  |   | 2003        |  
|                                                                                                   |  | (unaudited)                      |            |   | (unaudited)                     |   |            | (unaudited) |  |   | (unaudited) |  
|Net income (loss)as reported                                                                      |  | $                                | (1,300,292 | ) |                                 | $ | 855,509    |             |  | $ | (3,699,056  | ) |  | $ | (1,156,427 | )
|Add: stock-based employee compensation (benefit) included in reported net income (loss)            |  |                                  | 120,948    |   |                                 |   | (21,657    | )           |  |   | 224,958     |   |  |   | 30,450     |  
|Deduct: stock-based employee compensation deterimine under fair value based methods for all awards |  |                                  | (303,195   | ) |                                 |   | (207,949   | )           |  |   | (857,954    | ) |  |   | (685,780   | )
|                                                                                                   |  |                                  |            |   |                                 |   |            |             |  |   |             |   |  |   |            |  
|Pro forma net income (loss)                                                                        |  |                                  | (1,482,539 | ) |                                 |   | 625,903    |             |  |   | (4,332,052  | ) |  |   | (1,811,757 | )
|Less: accretion of preferred stock dividend and beneficial conversion feature                      |  |                                  | (1,479     | ) |                                 |   | (2,206,371 | )           |  |   | (412,452    | ) |  |   | (2,206,371 | )
|                                                                                                   |  |                                  |            |   |                                 |   |            |             |  |   |             |   |  |   |            |  
|Pro forma net loss                                                                                 |  | $                                | (1,484,018 | ) |                                 | $ | (1,580,468 | )           |  | $ | (4,744,504  | ) |  | $ | (4,018,128 | )
|                                                                                                   |  |                                  |            |   |                                 |   |            |             |  |   |             |   |  |   |            |  
|Basic loss per share, as reported                                                                  |  | $                                | (0.07      | ) |                                 | $ | (0.14      | )           |  | $ | (0.26       | ) |  | $ | (0.36      | )
|                                                                                                   |  |                                  |            |   |                                 |   |            |             |  |   |             |   |  |   |            |  
|Basic loss per share, pro forma                                                                    |  | $                                | (0.08      | ) |                                 | $ | (0.17      | )           |  | $ | (0.30       | ) |  | $ | (0.43      | )
|                                                                                                   |  |                                  |            |   |                                 |   |            |             |  |   |             |   |  |   |            |  



On July 24, 2002, the
Company granted an option to purchase 50,000 shares to a member of the Scientific Advisory Board with a four year vesting schedule. On May 21, 2003, the Company granted an option to purchase 50,000 shares to a member of the Scientific Advisory Board
with a four year vesting schedule. The Company re-measures the fair value of these options each quarter using the Black-Scholes option pricing model and records the corresponding non-cash expense throughout the vesting period of these options. As a
result, for the three months ended September 30, 2004, the Company increased additional paid-in capital by $12,994, decreased deferred compensation expense by $11,296 and recorded a non-cash compensation expense of $24,290 in the Statement of Loss.



On September 23, 2002, the Company repriced and/or exchanged
certain options previously granted to the Chief Executive Officer and Chief Financial Officer, which relate to a total of 850,000 shares of the Companys Common Stock. The new exercise prices for these options are between $.5189 and $2.55 per
share. The Company records the compensation expense over the vesting period and re-measures the intrinsic value each period throughout the life of these options. As a result, for the three months ended September 30, 2004, the Company increased
additional paid-in capital and deferred compensation by $136,034 and $15,842, respectively, and recorded a non-cash compensation expense of $120,192 in the Statement of Operations. This re-measurement may result in unpredictable charges or credits
to the Statement of Operations, which will depend on the fair value of the Companys Common Stock.



During the quarter ended September 30, 2003, one employee received an option with intrinsic value on the grant date of $12,000. As a result, for the three
months ended September 30, 2004, the Company decreased deferred compensation by $756 and recorded a non-cash compensation expense of $756 in the Statement of Operations.



During the quarter ended September 30, 2004, the Company granted options to purchase 8,000 shares of the Companys
common stock at exercise prices ranging from $1.68 to $2.24 to certain employees. During the quarter ended September 30, 2004, a total of 6,832 shares of common stock with a fair value of $11,956 were issued to the Companys 401(k) plan.



(g) Net Loss per Common Share



Basic and diluted net loss per share of the Companys common stock are
presented in conformity with SFAS No. 128, Earnings per Share, for all periods presented. For the periods presented, options, warrants and convertible securities were anti-dilutive and excluded from diluted loss per share calculations.
Accordingly, basic and diluted net loss per share of common stock has been computed by dividing the net loss applicable to common stockholders in each period by the weighted average number of shares of common stock outstanding during such period.



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SONTRA MEDICAL CORPORATION

Notes to Consolidated Financial Statements

September 30, 2004

(Unaudited)



(h) Research and Development Expenses



The Company charges research and development expenses to operations as incurred. Research and development expenses primarily consist of salaries and
related expenses for personnel and consulting services. Other research and development expenses include fees paid to consultants and outside service providers, the costs of materials used in research and development, information technology and
facilities costs.



(i) Revenue Recognition



For product revenue, revenues are recognized when persuasive evidence of an
arrangement exists in the form of a signed non-cancelable purchase order, the product is shipped, the selling price is fixed and determinable, and collection is reasonably assured.



(3) COMMITMENTS



The Company leases 12,999 square feet of office, laboratory and manufacturing space in Franklin, Massachusetts under a lease expiring March 10, 2008.
Minimum rental payments under this lease are approximately as follows:



|                                 |  |        |        
|-------------------------------- |  | ------ | -------
|                                 |  | Amount
|For the year ending December 31, |  |        |        
|2004                             |  | $      | 142,000
|2005                             |  |        | 163,000
|2006                             |  |        | 164,000
|2007                             |  |        | 172,000
|2008                             |  |        | 33,000 
|                                 |  |        |        
|Total                            |  | $      | 674,000
|                                 |  |        |        



(4) SERIES A CONVERTIBLE PREFERRED
STOCK FINANCING



In 2003, the Company completed a $7
million private placement to selected qualified purchasers of units consisting of shares of the Companys Series A Convertible Preferred Stock and warrants to purchase shares of the Companys Common Stock (the Private
Placement). Individual investors, institutions and certain members of the Board of Directors purchased 7,000,000 shares of the Companys Series A Convertible Preferred Stock, at a per share purchase price of $1.00. The investors also
received warrants to purchase up to 7,000,000 shares of Common Stock.



Each share of Series A Preferred Stock is initially convertible into one share of Common Stock, subject to adjustment in certain events. The holders of shares of Series A Preferred Stock are entitled to receive annual 8% dividends, payable
in cash or shares of Common Stock. The Company has the right to convert the shares of Series A Preferred Stock in the event that the closing price of the Common Stock for twenty consecutive trading days is equal to or greater than $3.00 per share.
The warrants issued to the purchasers in the Private Placement are exercisable at a per share price of $1.50 and expire no later than the fifth anniversary of their issuance date. In addition, the Company has the right to terminate the warrants,
upon thirty days notice, in the event that the closing price of the Common Stock for twenty consecutive trading days is equal to or greater than $4.00 per share. The warrants shall be exercisable during such thirty-day notice period.



In connection with the Private Placement, the placement agent received
warrants to purchase an aggregate of 800,000 shares of Common Stock. Such placement agent warrants are exercisable at a per share price of $1.20 and expire no later than the fifth anniversary of their issuance date. In addition, the Company has the
right to terminate the placement agent warrants, upon thirty days notice, in the event that the closing price of the Common Stock for twenty consecutive trading days is equal to or greater than $4.00 per share. The warrants shall be exercisable
during such thirty-day notice period.



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SONTRA MEDICAL CORPORATION

Notes to Consolidated Financial Statements

September 30, 2004

(Unaudited)



In conjunction with the 8% dividend on the Series A Preferred Stock, the Company accreted dividends of $1,479 for the three months ended September 30,
2004. As of September 30, 2004, there were 73,334 shares of Series A Convertible Preferred Stock outstanding.



During the quarter ended September 30, 2004, warrants to purchase 1,144,908 shares of common stock were exercised and the Company received $1,663,390 in
net cash proceeds.



(5) BAYER LICENSE AGREEMENT



On July 28, 2003, the Company and Bayer Diagnostics Division of Bayer
Healthcare LLC (Bayer) executed a definitive license agreement pursuant to which the Company granted to Bayer an exclusive worldwide right and license of the Companys intellectual property rights to make, have made, use, import and
sell a continuous non-invasive glucose monitoring system. In consideration of the license and the Companys delivery of all information, materials and know-how related to the licensed technology, on January 15, 2004, Bayer paid the Company a
one-time, non-refundable license fee of $1.5 million. The Company had recorded the $1.5 million license payment as accounts receivable and licensing revenue for the year ended December 31, 2003.



The Company and Bayer may also enter into one or more additional agreements
to continue the joint development of the continuous non-invasive glucose monitoring system. Such agreements may include, among other things, a $3.0 million milestone payment to the Company after the first phase of development of the product, a
royalty agreement providing for the payment by Bayer to the Company of royalties based on net sales of the product, and a manufacturing and supply agreement providing Sontra with the exclusive manufacturing rights of the SonoPrep device. There can
be no assurance that the Company and Bayer will enter into any additional agreements or that Bayer will make any further payments to the Company. In the event that Bayer does not complete the development of the product necessary to obtain FDA
approval, the license shall convert to a non-exclusive license. Bayer has the right to terminate the agreement at any time following the payment of the license fee. In the event that Bayer terminates the agreement following the payment of the
license fee, the license shall cease to be an exclusive license and shall become a co-exclusive license pursuant to which the Company will receive royalties based on net sales of the product.



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##### Table of Contents

Item 2. Managements Discussion and Analysis or Plan of Operation



Forward-Looking Statements



The following discussion of the consolidated financial condition and results of operations of the Company should be read in conjunction with the unaudited condensed consolidated financial statements and the related notes thereto included
elsewhere in this Form 10-QSB. Except for the historical information contained herein, the following discussion, as well as other information in this report, contain forward-looking statements within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created by those sections. Some of the forward-looking statements can be identified by the use of forward-looking
terms such as believes, expects, may, will, should, could, seek, intends, plans, estimates, anticipates or other
comparable terms. Forward-looking statements involve inherent risks and uncertainties. A number of important factors could cause actual results to differ materially from those in the forward-looking statements. We urge you to consider the risks and
uncertainties described in Factors That May Affect Future Results in this report. We undertake no obligation to update our forward-looking statements to reflect events or circumstances after the date of this report. We caution readers
not to place undue reliance upon any such forward-looking statements, which speak only as of the date made.



Overview



On June 20, 2002, the Company (previously operating under the name ChoiceTel Communications, Inc.) consummated a merger with Sontra Medical, Inc.
(SMI), pursuant to which SMI merged with and into a wholly owned subsidiary of the Company (the Merger). Subsequent to the consummation of the Merger, the Company changed its name to Sontra Medical Corporation and began
operating in SMIs line of business.



Sontra Medical
Corporation is the pioneer of SonoPrep®, a
non-invasive ultrasonic skin permeation technology for medical and therapeutic applications. Our proprietary ultrasound mediated skin permeation technology is a non-invasive and painless method of enhancing the flow of fluids and molecules across
the protective membrane of the stratum corneum, the outer layer of the skin.



A significant portion of the Companys research and development expenses include salaries paid to personnel and outside consultants and service providers, as well as the cost of materials used in research and
development, and information technology and facilities costs. The Company expects that its research and development expenses will continue to increase as it works to complete the development of its products, obtain regulatory clearances or
approvals, and conduct further research and development.



Selling, general and administrative expenses consist primarily of non-research personnel salaries and related expenses, facilities costs and professional fees. The Company expects selling, general and administrative expenses to increase as
it hires additional personnel and builds its infrastructure to support future growth.



Stock-based compensation expense, a non-cash expense, represents the difference between the exercise price and fair value of common stock on the date of option grant. Certain stock-based compensation expense is
remeasured each period and amortized over the vesting period of the applicable options, which is generally 42 months.



Financial Reporting Release No. 60, which was recently issued by the SEC, requires all registrants to discuss critical accounting policies or methods used
in the preparation of the financial statements. We do not believe that any of our current accounting policies or estimates reaches the level of being critical. However, we have made a number of estimates and assumptions that affect reported amounts
of assets, liabilities, revenues and expenses, and actual results may differ from those estimates. The areas that require the greatest degree of management judgment are the assessment of the recoverability of long-lived assets, primarily
intellectual property, the valuation of inventory and the realization, if any, of our net deferred tax assets.



We believe that full consideration has been given to all relevant circumstances that Sontra may be subject to, and the financial statements accurately
reflect Sontras best estimate of the results of operations, financial position and cash flows for the periods presented.



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Results of Operations



Comparison of the three and nine months ended September 30, 2004 versus 2003



Gross Margin



During the quarter ended September 30, 2004, Sontra commenced the marketing launch of the SonoPrep device and procedure trays for topical lidocaine
delivery. The Company made its first shipments of the SonoPrep device and procedure trays for topical lidocaine delivery and recorded revenue of $12,254 and a gross margin of $6,731. The Company expects to continue to refine its product costing and,
accordingly, gross margin on future sales may differ.



Research and
Development Expenses



Research and development expenses
increased by $217,000, to $726,000 for the quarter ended September 30, 2004 from $509,000 for the quarter ended September 30, 2003. Research and development expenses increased by $582,000 to $2,065,000 for the nine months ended September 30, 2004
from $1,483,000 for the nine months ended September 30, 2003. The increases for the three and nine months ended September 30, 2004 was primarily attributable to the hiring of additional personnel, costs incurred to build prototype SonoPrep skin
permeation devices and human clinical trial expenses for the transdermal delivery of lidocaine and vaccines.



Selling, General and Administrative Expenses



Selling, general and administrative expenses increased by $460,000 to $598,000 for the quarter ended September 30, 2004 from $138,000 for the quarter ended September 30, 2003. Selling, general and administrative
expenses increased by $504,000 to $1,692,000 for the nine months ended September 30, 2004 from $1,188,000 for the nine months ended September 30, 2003. The increases for the three and nine months ended September 30, 2004 were primarily attributable
to an increase in stock-based compensation expenses, the hiring of a Vice President of Sales and Marketing in June 2004, selling and marketing expenses incurred in the third quarter of 2004 for the SonoPrep product launch and increased costs
associated with being a public company.



Interest Income



Interest income was $18,000 for the quarter ended September 30, 2004
compared to interest income of $2,000 for the quarter ended September 30, 2003. Interest income was $49,000 for the nine months ended September 30, 2004 compared to interest income of $15,000 for the nine months ended September 30, 2003. The
increases in interest income for the three and nine months ended September 30, 2004 were attributable to the Company having a higher average invested cash balance in 2004 compared to 2003.



Liquidity and Capital Resources



The Company has financed its operations since inception primarily through
private sales of its preferred stock, the issuance of convertible promissory notes, and the cash it received in connection with the Merger. As of September 30, 2004, the Company had $6,274,000 of cash and cash equivalents on hand.



Net cash used in operating activities totaled $1,678,000 for the nine months
ended September 30, 2004. The net loss for the nine months ended September 30, 2004 was $3,699,000 and included in this loss were non-cash expenses of $117,000 for depreciation and amortization, $292,000 for stock-based compensation and $207,000 for
common stock contributed to the 401(k) plan. A decrease in accounts receivable provided $1,488,000 of cash and a decrease in accrued expenses used $113,000.



Net cash used in investing activities was $161,000 for the nine months ended September 30, 2004, resulting from the purchase of property and equipment,
consisting primarily of manufacturing equipment.



Net cash
provided by financing activities was $3,243,000 for the nine months ended September 30, 2004, as a result of proceeds of $3,086,000 from the issuance of common stock upon the exercise of warrants and proceeds of $157,000 from the issuance of common
stock upon the exercise of stock options.



The Company expects
that the cash and cash equivalents of $6,274,000 at September 30, 2004 will be sufficient to meet its cash requirements through September 2005. In addition, as of September 30, 2004, the Company has outstanding warrants to purchase an aggregate of
5,240,000 shares of common stock at an exercise price of $1.50 per share and warrants to purchase an aggregate of 419,092 shares of common stock at an exercise price of $1.20 per share. Upon any exercise of these warrants, the Company will receive
the aggregate exercise price.



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The Company will be required to raise a substantial amount of capital in the future to execute in
accordance with its product development, commercialization and marketing strategies. The Companys ability to fund its future capital requirements will depend on many factors, including the following:



| |  | its ability to obtain funding from third parties, including any future collaborative partners;
| | - | ----------------------------------------------------------------------------------------------



| |  | its progress on research and development programs and pre-clinical and clinical trials;
| | - | ---------------------------------------------------------------------------------------



| |  | the time and costs required to gain regulatory approvals;
| | - | ---------------------------------------------------------



| |  | the costs of manufacturing, marketing and distributing its products, if successfully developed and approved;
| | - | ------------------------------------------------------------------------------------------------------------



| |  | the costs of filing, prosecuting and enforcing patents, patent applications, patent claims and trademarks;
| | - | ----------------------------------------------------------------------------------------------------------



| |  | the status of competing products; and
| | - | -------------------------------------



| |  | the market acceptance and third-party reimbursement of its products, if successfully developed and approved.
| | - | ------------------------------------------------------------------------------------------------------------



Factors That May Affect Future Results



We operate in a rapidly changing environment that involves a number of
risks, some of which are beyond our control. Forward-looking statements in this document and those made from time to time by us through our senior management are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. Forward-looking statements concerning the expected future revenues or earnings or concerning projected plans, performance, or development of products and services, as well as other estimates related to future operations are necessarily
only estimates of future results and there can be no assurance that actual results will not materially differ from expectations. Forward-looking statements represent managements current expectations and are inherently uncertain. We do not
undertake any obligation to update forward-looking statements. Factors that could cause actual results to differ materially from results anticipated in forward-looking statements include, but are not limited to, the following:



We have a history of operating losses, and we expect our operating losses to continue for
the foreseeable future.



We have generated limited
revenues and have had operating losses since our inception. Our historical accumulated deficit was approximately $21,721,000 as of September 30, 2004. It is possible that the Company will never generate any additional revenue or generate enough
additional revenue to achieve and sustain profitability. Even if the Company reaches profitability, it may not be able to sustain or increase profitability. We expect our operating losses to continue for the foreseeable future as we continue to
expend substantial resources to conduct research and development, feasibility and clinical studies, obtain regulatory approvals for specific use applications of our SonoPrep® technology, identify and secure collaborative partnerships, and manage and execute our obligations in strategic
collaborations.



If we fail to raise additional capital, we will be unable
to continue our development efforts and operations.



The
Company has generated limited revenue since inception (from an historical accounting perspective), and does not expect to generate sufficient revenues to earn a profit in the near future. Our development efforts to date have consumed and will
continue to require substantial amounts of capital to complete the development of our SonoPrep®technology and to meet other cash requirements in the future. Our product development programs will require substantial additional clinical trials to demonstrate the efficacy of our products before we can begin to commercialize our
products under development. As we enter into more advanced product development of our SonoPrep device and our continuous non-invasive glucose monitoring system, we will need significant funding to pursue our product commercialization plans. We have
not begun to market or generate revenues from our products under development. Our ability to continue our research, development and testing activities and commercialize our products in development is highly dependent on our ability to obtain
additional sources of financing, including by entering into and maintaining collaborative arrangements with third parties who have the resources to fund such activities. Raising capital has become increasingly difficult for many companies. Any
future equity financing, if available, may result in substantial dilution to existing shareholders, and debt financing, if available, may include restrictive covenants or may require us to grant a lender a security interest in our assets. To the
extent that we attempt to raise additional funds through third party collaborations and/or licensing arrangements, we may be required to relinquish some rights to our technologies or products currently in various stages of development, or grant
licenses on terms that are not favorable to the Company. Any failure by the Company to timely procure additional financing or investment adequate to fund the Companys ongoing operations, including planned product development initiatives and
clinical studies, will have material adverse consequences on the Companys business operations and as a result, on our consolidated financial condition, results of operations and cash flows. If the Company is unable to raise sufficient
additional financing we will not be able to continue our operations.



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We have limited publicly available historical financial information, which makes it difficult to evaluate our
business.



Because limited publicly available historical
financial information is available on our business, it may be difficult to evaluate our business and prospects. Our business and prospects must be considered in light of the substantial risks, expenses, uncertainties and difficulties encountered by
entrants into the medical device industry, which is characterized by increasingly intense competition and a high failure rate. To date, we have engaged primarily in research and development efforts, prototype development and testing, and human
clinical feasibility studies. Our results of operations will depend on, among other things, the following factors:



| |  | research and development activities and outcomes;
| | - | -------------------------------------------------



| |  | results of feasibility and pre-clinical studies;
| | - | ------------------------------------------------



| |  | the ability to enter into collaborative agreements;
| | - | ---------------------------------------------------



| |  | the timing of payments, if any, under future collaborative agreements; and
| | - | --------------------------------------------------------------------------



| |  | costs related to obtaining, defending and enforcing patents.
| | - | ------------------------------------------------------------



The development and commercialization of our potential products, including the SonoPrep®device and the continuous non-invasive glucose monitoring system, will require the formation of strategic partnerships with third
parties, as well as substantial capital expenditures either by the Company or the strategic partner of the Company on research, regulatory compliance, sales and marketing and manufacturing.



Our future success is dependent upon successful collaborations with strategic partners.



Our future success is dependent upon our ability to
selectively enter into and maintain collaborative arrangements with leading medical device and pharmaceutical companies, such as Bayer Healthcare LLC (Bayer). On July 28, 2003, Sontra and Bayer executed a definitive license agreement
pursuant to which Sontra granted to Bayer an exclusive worldwide right and license of Sontras intellectual property rights to make, have made, use, import and sell a continuous non-invasive glucose monitoring system. Sontra and Bayer may also
enter into one or more additional agreements to continue the joint development of the continuous non-invasive glucose monitoring system. We may not be able to enter into any additional collaborative arrangements on acceptable terms, if at all. If we
are not able to collaborate with Bayer or additional partners, the business, financial condition and results of operations of the Company could be materially adversely affected.



Even if we were to enter into a collaborative arrangement, there can be no assurance that the financial condition or results
of operations of the Company will significantly improve. The risks involved with collaborating with strategic partners include, but are not limited to, the following:



| |  | such collaborative arrangements could terminate upon the expiration of certain notice periods;
| | - | ----------------------------------------------------------------------------------------------



| |  | funding by collaborative partners may be dependent upon the satisfaction of certain goals or milestones by certain specified dates, the realization or satisfaction of
which may be outside of our control;
| | - | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| |  | collaborative partners may retain a significant degree of discretion regarding the timing of these activities and the amount and quality of financial, personnel and other resources
that they devote to these activities;
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| |  | disputes may arise between the Company and any future collaborative partner regarding their respective rights and obligations under the collaborative arrangements, which may be
costly; and
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



| |  | any future collaborative partner may not be able to satisfy its obligations under its arrangement with the Company or may intentionally or unintentionally breach its obligations
under the arrangement.
| | - | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------



Most of our products are in early
stages of development, and we face risks of failure inherent in developing products based on new technologies.



Most of our products under development have a high risk of failure because they are in the early stages of development. To date, we have tested the
feasibility of our SonoPrep®technology for various applications, including glucose
monitoring, transdermal drug delivery and certain anesthetic applications. The Company has received 510(k) marketing clearance from the FDA for our SonoPrep®device for the transdermal delivery of lidocaine and in electrophysiology applications. However, to develop additional products,
substantial expenditures will be required, including feasibility studies, pre-clinical studies and clinical testing, the establishment of collaborative partnerships and regulatory, manufacturing, sales and marketing activities by collaborative
partners will be necessary for successful commercial production of our technologies or their incorporation into products of third parties.



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Our future prospects are substantially dependent on forming collaborative partnerships, further
developing our products and obtaining favorable results from pre-clinical studies and clinical trials and satisfying regulatory standards and approvals required for the market introduction of the SonoPrep®device and a continuous non-invasive glucose monitoring system. There can be no assurance that the Company or any strategic partner
of the Company will not encounter unforeseen problems in the development of the SonoPrep®technology, or that we or any such strategic partner will be able to successfully address the problems that do arise. In addition, there can be no assurance that any of our potential products will be successfully developed, proven safe and
efficacious in clinical trials, meet applicable regulatory standards, be capable of being produced in commercial quantities at acceptable costs, be eligible for third-party reimbursement from governmental or private insurers, be successfully
marketed or achieve market acceptance. If any of our development programs are not successfully completed, required regulatory approvals or clearances are not obtained, or potential products for which approvals or clearances are obtained are not
commercially successful, our business, financial condition and results of operations would be materially adversely affected.



Failure to obtain necessary regulatory approvals will prevent the Company or our collaborators from commercializing our products under development.



The design, manufacturing, labeling, distribution and marketing of our
potential products will be subject to extensive and rigorous government regulation in the United States and certain other countries. The process of obtaining and maintaining required regulatory clearance and approvals in the United States is
lengthy, expensive and uncertain. In order for us to market our potential products in the United States, we must obtain clearance by means of a 510(k) pre-market notification, or approval by means of a pre-market approval (PMA)
application, from the United States Food and Drug Administration (FDA). In February 2004, we received 510(k) marketing clearance from the FDA for our SonoPrep®device for use in electrophysiology applications. In August 2004, we received 510(k) marketing clearance from the FDA for the
SonoPrep device and procedure tray for use with topical lidocaine. We will need to obtain additional 510(k) marketing clearances from the FDA in order to market other products and applications. In order to obtain marketing clearance for our
continuous non-invasive glucose monitoring system, we will be required to file a PMA application that demonstrates the safety and effectiveness of the product. The PMA process is more rigorous and lengthier than the 510(k) clearance process and can
take several years from initial filing and require the submission of extensive supporting data and clinical information.



Even if we receive 510(k) clearance or PMA approval, there can be no assurance that the FDA will not impose strict labeling or other requirements as a
condition of our clearance or approval, any of which could limit our ability to market our products under development. Further, if we wish to modify a product after FDA clearance or approval, including changes in indications or other modifications
that could affect safety and efficacy, additional clearances or approvals could be required from the FDA. Any request by the FDA for additional data or any requirement by the FDA that we conduct additional clinical studies could significantly delay
the commercialization of our products and require us to make substantial additional research, development and other expenditures by the Company. Similarly, any labeling or other conditions or restrictions imposed by the FDA on the marketing of our
potential products could hinder the Companys ability to effectively market these products.



We must continue to meet the listing requirements of Nasdaq or we risk delisting.



Our Common Stock is currently listed for trading on the Nasdaq SmallCap Market. We must continue to satisfy Nasdaqs continued listing requirements,
including the minimum $2.5 million shareholder equity requirement, or risk delisting which would have an adverse effect on the Companys business.



If the Companys Common Stock is delisted from the Nasdaq SmallCap Market, it may trade on the over-the-counter market, which may be a less liquid
market. In such case, our stockholders ability to trade, or obtain quotations of the market value of, shares of Sontras Common Stock would be severely limited because of lower trading volumes and transaction delays. These factors could
contribute to lower prices and larger spreads in the bid and ask prices for our Common Stock. In addition, the delisting of the Common Stock from the Nasdaq SmallCap Market would significantly impair our ability to raise capital in the public
markets in the future.



A substantial portion of the intellectual property
used by the Company is owned by the Massachusetts Institute of Technology.



We have an exclusive world-wide license from the Massachusetts Institute of Technology (MIT) under certain licensed patents to practice our ultrasound-mediated skin permeation technology. These licensed patents, which
include eight issued patents in the United States, three issued foreign patents, two pending U.S. patents and three pending foreign patent applications, comprises a substantial portion of our patent portfolio relating to our technology.



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##### Table of Contents

While, under the license agreement, we have the right to advise and cooperate with MIT in the prosecution
and maintenance of the foregoing patents, we do not control the prosecution of such patents. Instead, the Company relies upon MIT to determine the appropriate strategy for prosecuting these patents. If MIT does not adequately protect our patent
rights, our ability to manufacture and market our products, currently in various stages of development, would be adversely affected.



We will need to protect the proprietary information on which our SonoPrep®technology relies.



We have an exclusive license from MIT on eight issued patents in the United States, three issued foreign patents, two pending U.S. patents and three
pending foreign patent applications, and as of September 30, 2004, we owned four issued patents and six pending patent applications in the United States and two foreign patent and fifteen pending foreign applications. We can provide no assurance
that patents will be issued from the patent applications, or, if issued, that they will be issued in a form that will be advantageous to the Company.



There can be no assurance that one or more of the patents owned or licensed by the Company will not be successfully challenged, invalidated or
circumvented or that we will otherwise be able to rely on such patents for any reason. If any of our patents or any patents licensed from MIT are successfully challenged or our right or ability to manufacture our future products (if successfully
developed and commercialized) were to be limited, our ability to manufacture and market these products could be adversely affected, which would have a material adverse effect upon our business, financial condition and results of operations.



In addition to patent protection, we rely on a combination of
copyright, trade secret and trademark laws, and nondisclosure, confidentiality agreements and other contractual restrictions to protect our proprietary technology. However, these legal means afford only limited protection and may not adequately
protect the rights or competitive advantage of the Company. We may not be able to prevent the unauthorized disclosure or use of our technical knowledge or other trade secrets by our employees. Nondisclosure and confidentiality agreements with third
parties may be breached, and there is no assurance that the Company would have adequate remedies for any such breach.



If we fail to protect our intellectual property rights, our competitors may take advantage of our ideas and compete directly against the Company. There
can be no assurance that competitors, many of whom have substantial resources and have made substantial investments in competing technologies, will not seek to apply for and obtain patents that limit our ability to make, use and sell our potential
products either in the United States or in foreign markets. Furthermore, if our intellectual property is not adequately protected, our competitors may be able to use our intellectual property to enhance their products and compete more directly with
the Company, which could prevent us from entering our products into the market or result in a decrease in our eventual market share.



We have limited manufacturing experience, which could limit our growth.



To successfully commercialize our SonoPrep skin permeation technology we will have to manufacture or engage others to manufacture the particular device
in compliance with regulatory requirements. We have limited manufacturing experience that would enable us to make products in the volumes that would be necessary for us to achieve significant commercial sales, and there can be no assurance that we
will be able to establish and maintain reliable, efficient, full scale manufacturing at commercially reasonable costs, in a timely fashion. Difficulties we encounter in manufacturing scale-up, or our failure to implement and subsequently maintain
our manufacturing facilities in accordance with good manufacturing practice regulations, international quality standards or other regulatory requirements, could result in a delay or termination of production. Companies, and especially small
companies in the medical device field, often encounter these types of difficulties in scaling up production, including problems involving production yield, quality control and assurance, and shortages of qualified personnel.



We may be subject to litigation or other proceedings relating to our patent rights.



The medical device industry has experienced extensive
litigation regarding patents and other intellectual property rights. In addition, the United States Patent and Trademark Office may institute litigation or interference proceedings against the Company. The defense and prosecution of intellectual
property proceedings are both costly and time consuming.



Litigation may be necessary to enforce patents issued to the Company, to protect trade secrets or know how owned by or licensed to the Company or to determine the enforceability, scope and validity of the proprietary rights of others. Any
litigation or interference proceedings involving the Company may require us to incur substantial legal and other fees and expenses. Such proceedings would also be time consuming and can be a significant distraction for employees and management,
resulting in slower product development and delays in commercialization. In addition, an adverse determination in litigation or interference proceedings could subject the Company to significant liabilities to third parties, require us to obtain
licenses from third parties or prevent us from selling our products, once developed, in certain markets, or at all, which would have a material adverse effect on our business, financial condition and results of operations.



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Our potential markets are highly competitive and most participants are larger, better capitalized, and more
experienced than Sontra.



The industries in which our
potential products may eventually be marketed are intensely competitive, subject to rapid change and significantly affected by new product introductions. Our continuous non-invasive glucose monitoring system will compete directly with glucose
monitoring products manufactured by Roche Diagnostics, LifeScan, Inc., a division of Johnson & Johnson, Bayer Corporation, MediSense, a division of Abbott Laboratories, Cygnus, Inc., SpectRx and TheraSense, Inc. The Companys
SonoPrep®device will also compete with numerous companies developing drug delivery
products such as Nektar Therapeutic Systems, Inc., Alkermes, Inc., Bioject, Inc., PowderJect Pharmaceuticals PLC, Antares Pharma, Inc., Becton Dickinson & Co., Aerogen, Inc. ALZA Corporation, a division of Johnson & Johnson, Norwood Abbey
Limited, Vyteris, Iomed and 3M Company.



Most of these
companies are already producing and marketing glucose monitoring or drug delivery products, are either publicly traded or a division of a publicly traded company, and enjoy several competitive advantages over the Company. In addition, several of our
competitors have products in various stages of development and commercialization similar to our SonoPrep®device and our continuous non-invasive glucose monitoring system. At any time, these companies and others may develop products that compete directly with our proposed product concepts. In addition, many of our competitors have
resources allowing them to spend significantly greater funds for the research, development, promotion and sale of new or existing products, thereby allowing them to respond more quickly to new or emerging technologies and changes in customer
requirements. For all of the foregoing reasons, we may not be able to compete successfully against our current and future competitors. If any of our competitors succeeds in developing a commercially viable product and obtaining government approval,
the business, financial condition and results of operations of the Company would be materially adversely affected.



We operate in an industry with significant product liability risk.



Our business will expose us to potential product liability claims that are inherent in the testing, production, marketing and sale of human diagnostic and
ultrasonic transdermal drug delivery products. While we intend to take steps to insure against these risks, there can be no assurance that we will be able to obtain insurance in amounts or scope sufficient to provide us with adequate coverage
against all potential liabilities. Our current product liability insurance provides for coverage in the amount of $2,000,000. A product liability claim in excess of our product liability insurance would have to be paid out of our cash reserves, if
any, and would harm our reputation in the industry and adversely affect our ability to raise additional capital.



Our management has significant influence over the control of Sontra.



Our officers and directors beneficially own a significant percentage of the outstanding shares of our Common Stock. Accordingly, our officers and
directors currently have significant influence over the outcome of any corporate transaction or other matters submitted to the shareholders for approval, including mergers, consolidations and the sale of all or substantially all of the
Companys assets, and also could prevent or cause a change in control. Third parties may be discouraged from making a tender offer or bid to acquire the Company because of this concentration of ownership.



If we are unable to retain or hire additional key personnel, we may not be able to sustain
or grow our business.



Our future success will depend upon
our ability to successfully attract and retain key scientists, engineers and other highly skilled personnel. With the exception of Dr. Thomas W. Davison, our President and Chief Executive Officer, and Sean Moran, our Chief Financial Officer, our
employees are at-will and not subject to employment contracts and may terminate their employment with the Company at any time. In addition, our current management team is understaffed and has very limited experience managing a public company subject
to the Securities and Exchange Commissions periodic reporting obligations. Hiring qualified management and technical personnel will be difficult due to the limited number of qualified professionals in the work force in general and the intense
competition for these types of employees in the medical device industry, in particular. We have in the past experienced difficulty in recruiting qualified personnel and there can be no assurance that we will be successful in attracting and retaining
additional members of management if the business begins to grow. Failure to attract and retain personnel, particularly management and technical personnel would materially harm our business, financial condition and results of operations.



Our stock price has been volatile and may fluctuate in the future.



The trading price of our Common Stock may fluctuate significantly. This
price may be influenced by many factors, including:



| |  | our performance and prospects;
| | - | ------------------------------



| |  | the depth and liquidity of the market for our Common Stock;
| | - | -----------------------------------------------------------



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| |  | sales by selling shareholders of shares issuable in connection with our private placement in 2003;
| | - | --------------------------------------------------------------------------------------------------



| |  | investor perception of us and the industry in which we operate;
| | - | ---------------------------------------------------------------



| |  | changes in earnings estimates or buy/sell recommendations by analysts;
| | - | ----------------------------------------------------------------------



| |  | general financial and other market conditions; and
| | - | --------------------------------------------------



| |  | domestic and international economic conditions.
| | - | -----------------------------------------------



Public stock markets have experienced, and are currently experiencing, extreme price and trading volume volatility, particularly in the technology and
life sciences sectors of the market. This volatility has significantly affected the market prices of securities of many technology companies for reasons frequently unrelated to or disproportionately impacted by the operating performance of these
companies. These broad market fluctuations may adversely affect the market price of our Common Stock. In addition, fluctuations in our stock price may have made our stock attractive to momentum, hedge or day-trading investors who often shift funds
into and out of stocks rapidly, exacerbating price fluctuations in either direction particularly when viewed on a quarterly basis.



Securities we issue to fund our operations could dilute or otherwise adversely affect our shareholders.



We will likely need to raise additional funds through public or private debt
or equity financings to fund our operations. If we raise funds by issuing equity securities, the percentage ownership of current stockholders will be reduced and the new equity securities may have rights senior to those of the shares of our Common
Stock. If we raise funds by issuing debt securities, we may be required to agree to covenants that substantially restrict our ability to operate our business. We may not obtain sufficient financing on terms that are favorable to investors or us. We
may delay, limit or eliminate some or all of our proposed operations if adequate funds are not available.



In addition, upon issuance of the shares of Common Stock issuable upon conversion of the outstanding shares of Series A Preferred Stock and the exercise
of outstanding warrants, the percentage ownership of current shareholders will be diluted substantially.



The availability of preferred stock for issuance may adversely affect our shareholders.



Our Articles of Incorporation, as amended, authorize our Board of Directors to fix the rights, preferences and privileges of, and issue up to 10,000,000
shares of, preferred stock with voting, conversion, dividend and other rights and preferences that could adversely affect the voting power or other rights of our shareholders. An aggregate of 7,000,000 shares of Series A Preferred Stock were issued
in our private placement in 2003, of which 73,334 were issued and outstanding as of September 30, 2004. The issuance of additional preferred stock or rights to purchase preferred stock may have the effect of delaying or preventing a change in
control of the Company. In addition, the possible issuance of additional preferred stock could discourage a proxy contest, make more difficult the acquisition of a substantial block of the Companys Common Stock or limit the price that
investors might be willing to pay for shares of the Companys Common Stock.



Anti-takeover effects of Minnesota law could discourage, delay or prevent a change in control.



As a publicly traded company, we are prohibited by the Minnesota Business Corporation Act, except under certain specified circumstances, from engaging in
any merger, significant sale of stock or assets or business combination with any shareholder or group of shareholders who own at least 10% of our Common Stock.



Item 3. Controls and Procedures



Disclosure
Controls and Procedures.



The Companys management,
with the participation of the Companys Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the Companys disclosure controls and procedures (as such term is defined in Rule 13a-15(e) under the
Securities Exchange Act of 1934, as amended (the Exchange Act)) as of the end of the period covered by this report. Based on such evaluation, the Companys Chief Executive Officer and Chief Financial Officer have concluded that, as
of the end of such period, the Companys disclosure controls and procedures are effective in recording, processing, summarizing and reporting, on a timely basis, information required to be disclosed by the Company in the reports that it files
or submits under the Exchange Act.



Internal Control Over Financial
Reporting.



There have not been any changes in the
Companys internal control over financial reporting (as such term is defined in Rule 13a-15(f) under the Exchange Act) during the Companys third fiscal quarter that have materially affected, or are reasonably likely to materially affect,
the Companys internal control over financial reporting.



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PART II: OTHER INFORMATION



Item 2. Unregistered Sales of Equity Securities and Use of Proceeds



During the third quarter of fiscal 2004, we issued and sold an aggregate of 1,144,908 shares of common stock pursuant to the exercise of outstanding
Common Stock Purchase Warrants. Pursuant to the terms of the warrants, the warrant holders paid exercise prices ranging from $1.20 to $1.50 per share to us in connection with such exercises, for an aggregate purchase price of $1,663,390. The shares
of common stock were issued and sold to the warrant holders in reliance on Section 4(2) of the Securities Act of 1933, as amended, as a sale by the issuer not involving a public offering. No underwriters were involved with the issuance and sale of
the shares of common stock.



We did not repurchase any shares
of common stock during the third quarter of fiscal 2004.



Item 5. Other Information



During
the quarter ended September 30, 2004, we made no material changes to the procedures by which shareholders may recommend nominees to our Board of Directors, as described in our most recent proxy statement.



Item 6. Exhibits



The Exhibits
listed in the Exhibit Index immediately preceding such Exhibits are filed with or incorporated by reference in this report.



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SIGNATURES



In accordance with 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 thereunto duly authorized.



|                        |  |                            |  |                                                        
|----------------------- |  | -------------------------- |  | -------------------------------------------------------
|                        |  | SONTRA MEDICAL CORPORATION
|                        |  |                           
|Date: November 10, 2004 |  | By:                        |  | /s/ THOMAS W. DAVISON                                  
|                        |  |                            |  | Thomas W. Davison President and Chief
Executive Officer
|                        |  |                           
|Date: November 10, 2004 |  | By:                        |  | /s/ SEAN F. MORAN                                      
|                        |  |                            |  | Sean F. Moran Chief Financial
Officer                  



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EXHIBIT INDEX



|     |  |                                                                                                                                                       
|---- |  | ------------------------------------------------------------------------------------------------------------------------------------------------------
|31.1 |  | Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.                                               
|     | 
|31.2 |  | Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.                                               
|     | 
|32.1 |  | Certification of the Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|     | 
|32.2 |  | Certification of the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.



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