Attached files

file filename
EX-31.1 - SECTION 302 CEO CFO CERTIFICATE - SYMBOLLON CORPsection302ceocfocert.htm
EX-32.1 - SECTION 906 CEO CFO CERTIFICATE - SYMBOLLON CORPsection906ceocfocert.htm


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC  20549
FORM 10-Q

(Mark One)

[x] QUARTERLY REPORT UNDER  SECTION 13 OR 15(d) OF THE SECURITIES
      EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2009

[ ] TRANSITION REPORT UNDER  SECTION 13 OR 15(d) OF THE SECURITIES
     EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _______ TO ________

Commission file number 0-22872
 

SYMBOLLON PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)

Delaware
 
36-3463683
(State of incorporation)
 
(I.R.S. employer identification no.)

99 West Street, Suite J
Medfield, Massachusetts
 
 
02052
(Address of principal executive offices)
 
(Zip Code)
 
 
(508) 242-7500
(Registrant’s telephone number, including area code)

Indicate by check mark whether the issuer: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act 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 __

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company.  See the definitions of “large-accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filer o
Accelerated filer o
Non-accelerated filer o
Smaller reporting company x
(Do not check if a smaller reporting company)

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).   Yes __  No _X_

As of November 13, 2009, 27,473,340 shares of Class A Common Stock of the issuer were outstanding.


1
 
 

 

SYMBOLLON PHARMACEUTICALS, INC.

INDEX

 
PAGE
PART I.  FINANCIAL INFORMATION
 
   
Item 1.                      Financial Statements
 
   
     Condensed Balance Sheets – September 30, 2009
 
(unaudited) and December 31, 2008
3
   
     Unaudited Condensed Statements of Operations
 
 – For the three and nine months ended
 
 September 30, 2009 and 2008                                                                           
5
   
     Unaudited Condensed Statements of Cash Flows
 
- For the nine months ended September 30, 2009 and 2008
6
 
 
   
     Notes to the Unaudited Condensed Financial Statements
7
   
Item 2.          Management’s Discussion and Analysis
 
Of Financial Conditions and Results of Operation
15
   
Item 3.           Quantitative and Qualitative Disclosures
 
About Market Risk                                           
18
   
Item 4T.        Controls and Procedures                                                                                                           
18
   
PART II.  OTHER INFORMATION
 
   
Item 1.             Legal Proceedings                                           
19
   
Item 1A.          Risk Factors                                           
19
   
Item 2.              Unregistered Sales of Equity Securities and Use of Proceeds
19
   
Item 3.              Defaults Upon Senior Securities                                                                           
19
   
Item 4.              Submission of Matters to a Vote of Security Holders                                                                                                           
19
   
Item 5.              Other Information
19
   
Item 6.               Exhibits
19
   
SIGNATURES                                                                                                                     
19
   
EXHIBIT INDEX                                                                                                                     
E-1

 

 


Symbollon Pharmaceuticals, Inc.
 
   
   
Condensed Balance Sheets
 
   
   
   
September 30,
2009
(unaudited)
   
December 31,
2008
 
             
Assets
           
             
Current assets:
           
Cash and cash equivalents
  $ 9,266     $ 66,242  
    Inventory
    -       30,085  
Prepaid expenses
    5,198       21,263  
                 
Total current assets
    14,464       117,590  
                 
Equipment and leasehold improvements, net of
  accumulated depreciation and amortization
    875       1,627  
                 
Other assets:
               
Patent and trademark costs, net of accumulated amortization
    188,531       206,216  
Deposit
    -       2,364  
                 
    $ 203,870     $ 327,797  


 

 



Symbollon Pharmaceuticals, Inc.
 
   
   
Condensed Balance Sheets
(Continued)
 
   
   
   
September 30,
2009
(unaudited)
   
December 31,
2008
 
             
Liabilities and Stockholders’ Equity (Deficit)
           
             
Current liabilities:
           
Accounts payable
  $ 97,601     $ 63,014  
Accrued payroll expenses
    57,348       -  
Accrued clinical development expenses
    112,763       112,765  
                 
Total current liabilities
    267,712       175,779  
                 
Stockholders’ equity (deficit):
               
Common stock, Class A, par value $.001 per share, 93,750,000 shares
  authorized, 27,473,340 and 16,473,340 shares issued and outstanding
  as of September 30, 2009 and December 31, 2008, respectively
      27,473         16,473  
Convertible common stock, Class B, par value $.001
  per share, 1,250,000 shares authorized and unissued
    -       -  
Preferred stock, par value $.001 per share, 5,000,000 shares
  authorized and unissued
    -       -  
Additional paid-in capital
    21,673,436       21,526,658  
Accumulated deficit
    (21,764,751 )     (21,391,113 )
                 
Total stockholders’ equity (deficit)
    (63,842 )     152,018  
                 
    $ 203,870     $ 327,797  
 
See accompanying notes to condensed financial statements.
 




 

 

Symbollon Pharmaceuticals, Inc.
 
   
Condensed Statements of Operations
(unaudited)
 
   
   
   
Three Months Ended
September 30,
   
Nine Months Ended
September 30,
 
   
2009
   
2008
   
2009
   
2008
 
                         
Revenue:
                       
    Net product sales
  $ 30,701     $ -     $ 32,272     $ -  
                                 
    Total revenues
    30,701       -       32,272       -  
                                 
Operating expenses:
                               
    Cost of goods sold
    30,722       -       31,440       -  
Research and development
    -       9,442       -       487,050  
General and administrative
    216,192       149,667       374,557       1,059,454  
                                 
Total operating expenses
    246,914       159,109       405,997       1,546,504  
                                 
Loss from operations
    (216,213 )     (159,109 )     (373,725 )     (1,546,504 )
                                 
Interest income
    -       1,637       85       10,295  
                                 
Net loss
  $ (216,213 )   $ (157,472 )   $ (373,640 )   $ (1,536,209 )
                                 
Net loss per share of common stock
                               
  – basic and diluted
  $ (.01 )   $ (.01 )   $ (.02 )   $ (.09 )
                                 
Weighted average number of common shares
  outstanding – basic and diluted
    27,473,340       16,473,340       20,180,300       16,298,687  
                                 
See accompanying notes to condensed financial statements.
 



 

 


Symbollon Pharmaceuticals, Inc.
 
   
Condensed Statements of Cash Flows
(unaudited)
 
   
   
Nine Months Ended
September 30,
 
   
2009
   
2008
 
             
Cash flows from operating activities:
           
             
    Net loss
  $ (373,640 )   $ (1,536,209 )
Adjustments to reconcile net loss to net cash used in
  operating activities:
               
Stock-based compensation
    47,777       797,224  
Issuance of securities for services rendered
    110,000       30,800  
Depreciation and amortization
    18,438       26,157  
Changes in operating assets and liabilities:
               
            Inventory
    30,085       -  
Prepaid expenses
    16,065       10,851  
Rent Deposit
    2,364       -  
Accounts payable and other current liabilities
    91,933       (209,330 )
                 
    Net cash used in operating activities
    (56,976 )     (880,507 )
                 
Cash flows from investing activities:
               
                 
Patent and trademark cost additions
    -       (21,979 )
                 
   Net cash used in investing activities
    -       (21,979 )
                 
Net decrease in cash and cash equivalents
    (56,976 )     (902,486 )
                 
Cash and cash equivalents, beginning of period
    66,242       1,102,381  
                 
Cash and cash equivalents, end of period
  $ 9,266     $ 199,895  
                 
Supplemental information:
There were no payments made for interest or income taxes during the nine months ended September 30, 2009 or 2008.
               
See accompanying notes to condensed financial statements.
 


 

 


Symbollon Pharmaceuticals, Inc.
 
Notes to Condensed Financial Statements
(unaudited)
 
 
1.         Description of
Business and
Basis of
Presentation
Symbollon Pharmaceuticals, Inc. (formerly Symbollon Corporation) was formed to develop and commercialize proprietary iodine-based products for infection control and treatment in biomedical and bioagricultural industries.
 
The success of future operations is subject to a number of risks similar to those of other companies in the same stage of development.  Principal among these risks are the Company’s cumulative operating losses, no assurance of profitable future operations, early state of market development, competition from substitute products or larger companies, dependence on key personnel and the uncertainty of additional future financing as needed.
 
Our financial statements for the interim period ended September 30, 2009 have been prepared in conformity with accounting principles generally accepted in the United States of America, which contemplate continuation of our Company as a going concern.  We had a net loss of $1,784,105 and $373,640 and negative cash flows from operations of $1,019,600 and $56,976 for the year ended December 31, 2008 and nine months ended September 30, 2009, respectively.  At September 30, 2009, we also had an accumulated deficit of $21,764,751 and negative working capital of $253,248.  These factors raise substantial doubt as to our ability to continue as a going concern.  These financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts, or amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern and, therefore, be required to realize the Company’s assets and discharge our liabilities in other than the normal course of operations.
 
The ability of the Company to continue as a going concern is dependent upon the Company’s ability to receive continued financial support from the Company’s creditors, stockholders and external investors and to increase sales of IoGen, our dietary supplement marketed to promote breast health for women.  Management is actively seeking equity and debt financing from external investors, and is attempting to increase sales of IoGen.  The Company is also pursuing other strategic options, including possible sales or licenses of its technology or a sale or merger of the Company.  In December 2008, the Company transferred certain intellectual property in exchange for an equity stake in BioCide Pharma, Inc., a start-up company, and the assumption of approximately $18,000 in debt.  On June 30, 2009, Symbollon Pharmaceuticals, Inc. signed a distribution agreement with Integra Labs, Inc. granting Integra the exclusive right to distribute IoGen in countries allowing over-the-counter sales of the product.  Under the agreement, Integra will assume all manufacturing, sales and marketing responsibilities for the product.  Integra purchased Symbollon’s existing inventory of IoGen at cost.  Integra shall pay Symbollon a royalty on all sales of IoGen.
 
Failure to either obtain the support of additional external investors to finance the Company’s operations, increase sales of IoGen or execute our other strategic options will cause us to cease operations in the near future.

7
 
 

 


Symbollon Pharmaceuticals, Inc.
 
Notes to Condensed Financial Statements
(unaudited)
 
 
2.         Summary of
Significant
Accounting Policies
 
The accompanying unaudited financial statements do not contain all of the disclosures required by generally accepted accounting principles and should be read in conjunction with the financial statements and related notes included in our Form 10-K for the year ended December 31, 2008 filed with the Securities and Exchange Commission.
 
In the opinion of management, the financial statements reflect all adjustments, all of which are of a normal recurring nature, to fairly present our financial position, results of operations and cash flows.  The results of operations for the nine-month period ended September 30, 2009 are not necessarily indicative of the results to be expected for the full year.
 
The accounting policies that management believes are most critical to aid in fully understanding and evaluating our reported financial results include the following:
 
Use of Estimates
The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.  Actual results could differ from those estimates.
 
Cash and Cash
Equivalents
Cash and cash equivalents include short-term, highly liquid investments with maturities of less than three months when acquired.
 
Concentration of
Credit Risks
In 2008, the Company launched IoGen as a dietary supplement for the promotion of female breast health.  In June 2009, the Company entered into a distribution agreement with Integra Labs.  Under the agreement Integra will pay a royalty on all IoGen sales.  The Company had no accounts receivables as of September 30, 2009.
 
Inventory
Inventory is stated at the lower of cost (determined on a first-in, first-out basis) or market.
 
Long-Lived Assets
Long-lived assets, such as intangible assets and property and equipment, are evaluated for impairment when events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable through the estimated undiscounted future cash flows from the use of these assets.  When any such impairment exists, the related assets are written down to fair value.  The Company does not believe that any of its long-lived assets are impaired at September 30, 2009.
 
   

  8
 

 


Symbollon Pharmaceuticals, Inc.
 
Notes to Condensed Financial Statements
(unaudited)
 
 
2.         Summary of
Significant
Accounting Policies
(Continued)
 
 
Depreciation and
Amortization
Equipment is stated at cost and is depreciated over its estimated useful life (ranging from 5-7 years) using the straight-line method.
 
Intangible Assets
Intangible assets subject to amortization consist of patents and trademarks that have estimated useful lives ranging from 9-17 years and a remaining weighted average useful life of 7.2 years.  Costs related to patent applications are capitalized as incurred and are amortized once the patent application is accepted or are expensed if the application is rejected or there are other circumstances that indicate that the asset is impaired (as described above).
 
Income Taxes
The Company follows the liability method of accounting for income taxes, as set forth in the Financial Accounting Standards Board (“FASB”) guidance.  Under this method, deferred tax liabilities and assets are recognized for the expected future tax consequences of temporary differences between the carrying amount and the tax basis of assets and liabilities.  The Company records a valuation allowance against deferred tax assets unless it is more likely than not that such asset will be realized in future periods.
 
Fair value of
Financial
Instruments
 
The carrying amounts of cash and cash equivalents, other current assets and accounts payable approximate fair value based on their short-term maturities.
 
Equity
Investment
On December 8, 2008, the Company acquired 625,000 shares of common stock in BioCide Pharma, Inc., a start-up venture, in exchange for a transfer of certain patent rights and assumption of liabilities.  The Company will account for this investment on the equity method.  At September 30, 2009, the Company’s investment had no recorded value.
 
Revenue
Recognition
The Company recognizes revenue from its product sales and licensing arrangements in accordance with SEC Staff Accounting Bulletin No. 104, “Revenue Recognition.”  Under these guidelines, revenue is recognized when persuasive evidence of an arrangement exists, delivery has occurred or services rendered, the price is fixed or determinable and payment is reasonably assured.

 

 


Symbollon Pharmaceuticals, Inc.
 
Notes to Condensed Financial Statements
(unaudited)
 
 
2.         Summary of
Significant
Accounting Policies
(Continued)
 
 
Research and
Development
 
Research and development costs are expensed as incurred.
Stock-Based
Compensation
 
The Company accounts for share-based compensation based on the option's fair value and the vesting period of the award.
 
Loss Per Share
Basic earnings per share excludes the effect of any dilutive options, warrants or convertible securities and is computed by dividing the net earnings available to common shareholders by the weighted average number of common shares outstanding for the period.  Diluted earnings per share is computed by dividing the net earnings available to common shareholders by the sum of the weighted average number of common shares and common share equivalents computed using the average market price for the period under the treasury stock method.
 
Adoption of Warrant
Accounting
 
In June 2008, FASB issued guidance for determining whether an equity-linked financial instrument (or embedded feature) is indexed to an entity’s own stock. This guidance applies to any freestanding financial instrument or embedded feature that has all the characteristics of a derivative. This guidance is effective for fiscal years beginning after December 15, 2008.  We have concluded that adoption of this guidance does not have a material impact on the Company’s financial statements.

10 
 

 


Symbollon Pharmaceuticals, Inc.
 
Notes to Condensed Financial Statements
(unaudited)
 
 

3.         Stockholders’
Equity
 
 
Capital Stock
The Company has authorized 93,750,000 shares of Class A common stock, 1,250,000 shares of Class B common stock and 5,000,000 shares of preferred stock.  The Class A and Class B common stock are substantially identical except that holders of Class A common stock have the right to cast one vote for each share held and the Class B shareholders have the right to cast five votes for each share held.  As of September 30, 2009 and December 31, 2008, there were no shares of Class B common stock issued and outstanding.  The preferred stock may be issued in series, and shares of each series will have such rights and preferences as are fixed by the Company’s Board of Directors.  As of September 30, 2009 and December 31, 2008, there were no shares of preferred stock issued and outstanding.
 
Issuance of Common
Stock and Common
           Stock Purchase
           Warrants
 
On January 18, 2008, the Company entered into a services agreement with The Number One Corporation.  In accordance with the services agreement, and as partial consideration for the services provided by the vendor, the Company agreed to issue 40,000 shares of Class A common stock upon execution of the agreement.  The Company has determined the fair value of the shares to be $30,800 which was recognized as an expense in general and administrative expenses in the accompanying statement of operations for the nine month periods ended September 30, 2008.  No expense related to these shares was recognized for the nine month period ended September 30, 2009.
 
On February 7, 2008, the Company issued 900,000 and 375,000 restricted shares to its executive officers, Merrs. Desjourdy and Kessler, respectively.  The shares were initially to vest one-third each of the next three anniversaries of the grant date.  On May 16, 2008, the Company fully vested the shares as part of the termination of the executive officers’ employment agreements.  The Company recorded $637,500 of stock-based compensation for the nine month period ended September 30, 2008, with $450,000 and $187,500 included in general and administrative expenses and in research and development costs, respectively.  No expense related to these shares was recognized for the nine month period ended September 30, 2009.
 
On June 29, 2009, the Company issued 10,000,000 shares to its executive officer, Mr. Desjourdy.  The Company recorded $100,000 of stock-based compensation for the three and nine month periods ended September 30, 2009 in accordance with applicable FASB guidance.
 
At September 30, 2009, warrants to purchase 7,293,732 shares of common stock are outstanding.

11 
 

 


Symbollon Pharmaceuticals, Inc.
 
Notes to Condensed Financial Statements
(unaudited)
 
 
4.         Stock Plans
 
 
The Company has adopted two stock plans: a stock option plan and a nonemployee directors’ stock option plan.
 
The stock option plan provides for the grant of incentive stock options, nonqualified stock options and stock appreciation rights.  The stock option plan expired on August 4, 2008 with options to purchase 1,225,000 shares outstanding at September 30, 2009.  No future grants may be made under this plan.
 
The nonemployee directors’ stock option plan provides for the grant of nonstatutory stock options automatically on January 1 of each calendar year.  The Company has reserved 500,000 shares for issuance under the plan.  Each outside director shall be granted an option to purchase 10,000 shares of Class A common stock at fair market value, vesting 50% on each of the first two anniversaries of the grant.  The nonemployee directors’ stock option plan expires on the first business day of 2017.  There are 400,000 shares available for future grant or purchase under this plan.
 
The Company issued stock options to its employees and outside directors pursuant to stockholder approved stock option plans.  Option awards are generally granted with an exercise price equal to the market price of the Company’s stock at the date of grant.  Employee option awards generally vest over three years from the date of grant, and outside directors option awards generally vest over two years from the date of grant.  All option awards generally have 10-year contractual terms.  The Company attributes stock-based compensation cost to operations using the straight-line method over the applicable vesting period.
 
The Company recorded $115,926 and $54,016 of stock-based compensation in general and administrative expenses for the three month periods ended September 30, 2009 and 2008, respectively.  The Company recorded $147,778 and $159,724 of stock-based compensation in general and administrative expenses for the nine month periods ended September 30, 2009 and 2008, respectively.  As of September 30, 2009, the unrecognized stock-based  compensation cost related to non-vested stock awards was $18,430.  This amount will be recognized in operations over a weighted average period of 3 months.
   

12 
 

 


Symbollon Pharmaceuticals, Inc.
 
Notes to Condensed Financial Statements
(unaudited)
 
 
4.         Stock Plans
(Continued)
The following table summarizes the Company’s stock option information as of and for the nine month period ended September 30, 2009:

 
 
 
Number of
Shares
 
Weighted
Average
Exercise
Price
Weighted Average
Remaining
Contractual
Term
 
 
Aggregate
Intrinsic
Value (1)
         
Outstanding at December 31, 2008
1,345,000
$       0.90
   
 
  Options granted
 
40,000
 
$       0.01
   
  Options expired
(7,500)
$       1.60
   
 
Outstanding at September 30, 2009
 
1,377,500
 
$       0.87
 
7.3
 
$800
 
Exercisable at September 30, 2009
 
1,197,500
 
$       0.93
 
7.0
 
$0
 
(1)  The intrinsic value of a stock option is the amount by which the current market value of the underlying stock exceeds the option exercise price.

 
No stock options wre granted during the three month periods ended September 30, 2009 and 2008.  For the nine month periods ended September 30, 2009 and 2008, the Company granted options for 40,000 and 180,000 shares exercisable between $0.01 and $0.65 per share.  The weighted-average grant date fair value of stock options granted during the nine month periods ended September 30, 2009 and 2008 was $0.01 and $0.39 per share, respectively.  No stock options were exercised during the nine month periods ended September 30, 2009 or 2008.
 
The fair value of each option granted was estimated on the date of grant using the Black-Scholes option-pricing model with the following assumptions:

   
Nine Months Ended
September 30,
   
2009
2008
       
Weighted-average expected stock-price  volatility
 
143%
88%
       
    Weighted-average expected option life
 
6 years
6 years
           
    Average risk-free interest rate
 
1.72%
2.79-3.28%
       
    Average dividend yield
 
0.0%
0.0%


13 
 

 


Symbollon Pharmaceuticals, Inc.
 
Notes to Condensed Financial Statements
(unaudited)
 
 
4.         Stock Plans
(Continued)
The dividend yield of zero is based on the fact that the Company has never paid cash dividends and has no present intention to pay cash dividends.  Expected volatility is based on the historical volatility of the Company’s common stock over the period commensurate with the expected life of the options.  The risk-free interest rate is the U.S. Treasury Strips rate on the date of grant.  The expected life was calculated using the method outlined in SEC Staff Accounting Bulletin Topic 14.D.2, “Expected Terms,” as the Company’s historical experience does not provide a reasonable basis for the expected term of the option.  Based on the recent history and current expectations, the Company has not adjusted the calculated value of the options for the nine month periods ended September 30, 2009 to reflect a forfeiture rate.
 
5.        Loss Per Share
The Company’s basic and diluted net loss per share of common stock for the three and nine month periods ended September 30, 2009 and 2008 is computed by dividing the net loss by the weighted average number of common shares outstanding during the period.
 
The following table summarizes securities that were outstanding as of September 30, 2009 and 2008 but not included in the calculation of diluted net loss per share because such shares are antidilutive:
 

September 30,
2009
2008
     
Stock options
1,377,500
1,645,000
Stock warrants
7,293,732
7,929,193

6.     Distribution Agreement
On June 30, 2009, Symbollon Pharmaceuticals, Inc. signed a distribution agreement with Integra Labs, Inc. granting Integra the exclusive right to distribute Symbollon’s IoGen in countries allowing over-the-counter sales of the product.  Under the agreement, Integra will assume all manufacturing, sales and marketing responsibilities for the product.  Integra purchased Symbollon’s existing inventory of IoGen at cost.  Integra shall pay Symbollon a royalty on all sales of IoGen.  The initial term of the agreement is for five years, subject to the achievement of certain milestones and minimum sales requirements.  Pursuant to the agreement, the parties intend to identify other OTC product opportunities for Symbollon’s iodine technology which would be distributed by Integra.
   
   


  14
 

 

Item 2.  Management's Discussion and Analysis of Financial Condition and Results of Operation

The following discussion contains forward-looking statements which involve risks and uncertainties.  See “Forward Looking Statements” below and “Risk Factors” in the Annual Report on Form 10-K for the year ended December 31, 2008.

Overview

We are a specialty pharmaceutical company.  We have a formulation iodine-based proprietary technology that has potential product applications in the areas of infection control and women’s healthcare.  In 1995, we launched our first commercial product, IodoZyme.  Through March 31, 2007, it generated approximately $2.8 million in sales.  IodoZyme is no longer being sold.

Since 2000, we have concentrated our product development efforts on the proposed product application for the treatment of fibrocystic breast disease.  In March 2008, we discontinued clinical development of the proposed product, IoGen, and decided to commercialize IoGen as a dietary supplement to promote breast health.  We launched commercial sale of IoGen in November 2008.  We do not have adequate cash reserves to continue base operations.  In order for us to continue our operations, we must raise additional resources, increase sales of IoGen or sell the Company or some of our assets.  If we cannot secure additional resources, adequately increase sales of IoGen or sell some or all of our assets before existing resources are exhausted, we will have to cease operations.

Going Concern

Our financial statements for the interim period ended September 30, 2009 have been prepared in conformity with accounting principles generally accepted in the United States of America, which contemplate continuation of our company as a going concern.  We had a net loss of $1,784,105 and $373,640 and negative cash flows from operations of $1,019,600 and $56,976 for the year ended December 31, 2008 and nine months ended September 30, 2009, respectively.  At September 30, 2009, we also had an accumulated deficit of $21,764,751 and negative working capital of $253,248.  We do not have adequate cash resources to continue our base operation.  These factors raise substantial doubt as to our ability to continue as a going concern.

The application of the going concern concept is dependent upon the Company’s ability to receive continued financial support from the Company’s creditors, stockholders and external investors and to increase sales of IoGen, our dietary supplement marketing to promote breast health for women.  Management is actively seeking equity and debt financing from external investors, and is attempting to increase sales of IoGen.  The Company is also pursuing other strategic options, including possible sales or licenses of its technology or a sale or merger of the Company.  There can be no assurance that management's efforts will be successful.  Failure to either obtain the support of additional external investors to finance the Company’s operations, increase sales of IoGen or execute our other strategic options will cause us to cease operations in the near future.
 
 
15


 
Forward-Looking Statements

In addition to the historical information contained herein, this Quarterly Report on Form 10-Q contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to statements concerning plans, objectives, goals, strategies, prospects, revenues, liquidity and capital resources, financial needs and future performance, costs and expenditures.  Such statements may be identified or qualified, without limitation, by words such as "likely", "will", "suggests", "may", "would", "could", "should", "expects", "anticipates", "estimates", "plans", "projects", "believes", or similar expressions (and variants of such words or expressions).  Investors are cautioned that forward-looking statements are inherently uncertain.  Actual performance, achievements and results may differ materially from those expressed, projected or suggested in the forward-looking statements due to certain risks and uncertainties, including, but not limited to, uncertainty about our ability to continue as a going concern, our ability to raise any additional financing in light of the IoGen failure, history (and expectation) of losses, uncertainty associated with preclinical and clinical testing, market acceptance, intense competition, lack of marketing experience, materials incompatibility, hazardous materials, and the other risks and uncertainties described or discussed in the section "Risk Factors" in the Annual Report on Form 10-K for the year ended December 31, 2008.  The forward-looking statements contained herein represent our judgment as of the date of this Quarterly Report on Form 10-Q, and we caution readers not to place undue reliance on such statements.

Results of Operations

Symbollon's net loss for the three-month period ended September 30, 2009 was $216,213, reflecting an increase of $58,741 from a net loss of $157,472 in the comparable 2008 period.  Symbollon's net loss for the nine-month period ended September 30, 2009 was $373,640, reflecting a decrease of $1,162,569 from a net loss of $1,536,209 in the comparable 2008 period.  The increased loss for the three-month period resulted primarily from increase stock-based employee compensation, partially offset by decreased clinical development expenses.  The decreased loss for the nine-month period resulted primarily from decreased clinical development expenses related to the clinical trials of IoGen, employee salaries and consulting and other third party expenses.  We expect to continue to incur operating losses for the foreseeable future.

Product revenues from sales of IoGen (our dietary supplement for breast health) for the three and nine-month periods ended September 30, 2009 were $30,701 and $32,272, respectively.  IoGen was launched for commercial sale in November 2008, and thus, there were no product revenues from sales of IoGen for the three and nine-month periods ended September 30, 2008.  Cost of goods sold for IoGen were $30,722 and $31,440 for the three and nine-month periods ended September 30, 2009, respectively.
 
 
16


 
Research and development expense for the three-month period ended September 30, 2009 was $0, reflecting a decrease of $9,442 from the research and development expenses in the comparable 2008 period.  Research and development expense for the nine-month period ended September 30, 2009 was $0, reflecting a decrease of $487,050 from the research and development expenses in the comparable 2008 period.  The decrease resulted from cessation of our research and development efforts, including the IoGen clinical trials.  We do not anticipate incurring further research and development expenses, unless and until, additional resources are secured by us.

General and administrative expenses for the three-month period ended September 30, 2009 were $216,192, reflecting an increase of $66,525 from the general and administrative expenses in the comparable 2008 period.  General and administrative expenses for the nine-month period ended September 30, 2009 were $374,557, reflecting a decrease of $684,897 from the general and administrative expenses in the comparable 2008 period.  The decrease in the general and administrative expenses was primarily due to decreased employee salaries and consulting and other third party expenses.  We anticipate that general and administrative expenses will decrease from current levels as we limit, or cease, activities over the remainder of 2009.

Our interest income for the three-month period ended September 30, 2009 was $0, reflecting a decrease of $1,637 from the interest income in the comparable 2008 period.  Our interest income for the nine-month period ended September 30, 2008 was $85, reflecting a decrease of $10,295 from the interest income in the comparable 2008 period.  The decrease resulted from a decrease in available funds for investment and in interest rates available on invested funds.

Financial Condition, Liquidity and Capital Resources

We have funded our activities primarily through proceeds from private and public placements of equity securities.  During 1999, we sold 836,685 shares of common stock, together with warrants for a like number of shares, in a private placement, realizing net proceeds of approximately $1,356,000.  During 2000, we received net proceeds of approximately $1,761,000 from the exercise of 586,910 warrants issued as part of the 1999 private placement.  During 2004, we sold 1,261,692 shares of common stock, together with 630,846 warrants, in a private placement, for net proceeds of approximately $634,000 in cash and approximately $186,000 in prepaid services for manufacturing, consulting and clinical trial expenses.  During 2005, we sold 1,642,795 shares of Class A Common Stock for gross proceeds of $853,957 (aggregate net proceeds were $800,585) in an offering exclusively to foreign investors pursuant to Regulation S.  From December 2005 through March 2006, we issued 615,461 shares of Class A common stock and a like number of warrants for $332,775 in cash and prepaid consulting services upon exercise of privately placed warrants.  In June and August 2006, we sold 1,366,500 shares of common stock, together with warrants for a like number of shares, in a private placement, realizing net proceeds of approximately $1,342,340.  In December 2006 and January 2007, Symbollon raised net aggregate proceeds of $2,368,038 in a private placement of 3,213,632 shares of its Class A common stock and warrants for 2,410,224 shares.  From September through December 2007, Symbollon raised net proceeds of $1,704,350 in a private placement of 2,573,086 shares of its Class A common stock and a like number of warrants.
 
 
17

 
 
We continued to incur operating losses and have incurred a cumulative loss through September 30, 2009 of $21,764,751.  We also continue to have negative cash flow from operations of $56,976 for the nine months ended September 30, 2009.  As of September 30, 2009, we had negative working capital of $253,248.  We do not have the necessary liquidity and capital resources to sustain operations.  We are actively seeking equity and debt financing from external investors, and are attempting to increase sales of IoGen.  Any funding we do raise may be dilutive to existing stockholders.   We are also pursuing other strategic options, including possible sales or licenses of our technology or a sale or merger.  There can be no assurance that our efforts will be successful.  Failure to either obtain the support of additional external investors to finance the Company’s operations, increase sales of IoGen or execute our other strategic options will cause us to cease operations in the near future.

The report of our independent registered public accountants  on our financial statements for the year ended December 31, 2008 contains an explanatory paragraph, which indicates that we have incurred recurring losses and negative cash flows from operations that raises substantial doubt about our ability to continue as a going concern.  This report is not viewed favorably by analysts or investors and may make it more difficult for us to raise additional debt or equity financing needed to continue our operations.

We have no other material capital expenditures planned during fiscal 2009.  At December 31, 2008, we had a net operating loss carryforward for federal income tax purposes of approximately $18,171,000 expiring at various dates through 2028 (from which, however, we may never receive a benefit).

Item 3.  Quantitative an Qualitative Disclosures About Market Risk

Not applicable.

Item 4T.  Controls and Procedures

Evaluation of Disclosure Controls and Procedures

The Company’s management carried out an evaluation, with the participation of its Chief Executive Officer and Chief Financial Officer, of the effectiveness of the Company’s disclosure controls and procedures as of September 30, 2009.  Based upon that evaluation, in light of the absence of any segregation of duties, the Company’s Chief Executive Officer and Chief Financial Officer concluded that the Company’s disclosure controls and procedures were not effective to ensure that information required to be disclosed by the Company in reports that the Company files or submits under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) is recorded, processed, summarized and reported, within the time periods specified in the rules and forms of the Securities and Exchange Commission.

Changes in Internal Control Over Financial Reporting

There has not been any change in the Company’s internal control over financial reporting in connection with the evaluation required by Rule 13a-15(d) under the Exchange Act that occurred during the quarter ended September 30, 2009 that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.  The material weakness in our internal control over financial reporting described in our Annual Report on Form 10-K for the year ended December 31, 2008 (absence of adequate segregation of duties) continues unremediated, due to our limited resources and employees.
 
 
18


 
Part II - Other Information

Item 1. Legal Proceedings

To the best knowledge of the officers and directors, the Company is not a party to any legal proceeding or litigation.

Item 1A. Risk Factors

As a “smaller reporting company” defined by Item 10 of Regulation S-K, the Company is not required to provide this information.

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

None

Item 3. Defaults Upon Senior Securities

None.

Item 4. Submission of Matters to a Vote of Security Holders

None.

Item 5. Other Information

On October 1, 2009, the Company issued stock options to purchase 500,000 shares of Class A common stock to each of its four non-employee directors.  The options will vested one-half each of the next two anniversaries of the grant date.  The Company also revised the previous June 2009 stock grant to its executive officer by fully vesting such shares.

Item 6. Exhibits

See Index to Exhibits on page E-1.

SIGNATURES

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

 
SYMBOLLON PHARMACEUTICALS, INC.
   
Date: November 16, 2009
By: /s/ Paul C. Desjourdy____________________
 
Paul C. Desjourdy, President/CEO/CFO and authorized signatory
 
 

19
 
 

 

EXHIBIT INDEX

 
Exhibit Number
 
 
Exhibit Description
 
31.1
Certification of Paul C. Desjourdy, the Chief Executive Officer and Chief Financial Officer of the Company, required by Securities Exchange Act Rule 13a-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
 
32.1
Certification of Paul C. Desjourdy, the Chief Executive Officer and Chief Financial Officer of the Company, required by Securities Exchange Act Rule 13a-14(b) and 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
 

E-1