UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.  20549

FORM 10-Q

[X] Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

For the quarterly period ended August 31, 2011

or

[   ] Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for

the transition period from ________________ to __________________.

Commission File Number 000-49817

GENOSYS, INC.

(Exact Name of Small Business Issuer as specified in its Charter)

86 N. University Ave., Suite 400, Provo, UT 84601

(Address of principal executive offices, including zip code)

(801) 623-4751

(Registrant’s telephone number, including area code)

Indicate by check whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 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 þ  No ¨    

Indicate by check mark whether the Registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).                                                                                                                           Yes þ  No ¨    

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

Large Accelerated Filer  ¨

Accelerated Filer   ¨

 

Non-Accelerated Filer    ¨

Smaller reporting company     þ

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  

Yes ¨  No þ

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Applicable Only to Issuers Involved in Bankruptcy Proceedings During the Preceding Five Years:

Indicate by check mark whether the Registrant has filed all documents and reports required to be filed by Section 12, 13 or 15(d) of the Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court.

Not applicable.

Applicable Only to Corporate Issuers:

Indicate the number of shares outstanding of each of the Registrant’s classes of common stock, as of the latest practicable date.

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TABLE OF CONTENTS

PART I – FINANCIAL INFORMATION

Item 1:  Financial Statements

Condensed Consolidated Balance Sheets

As of August 31, 2011, and November 30, 2010

  

  4

Condensed Consolidated Statements of Operations

For the three and nine months ended August 31, 2011 and 2010 and for the period of the

development stage (June 30, 2005) through August 31, 2011

 

 

  5

Condensed Consolidated Statements of Cash Flows

For the nine months ended August 31, 2011 and 2010 and for the period of the

development stage (June 30, 2005) through August 31, 2011

  6

Notes to Condensed Consolidated Financial Statements

  7

Item 2:  Management’s Discussion and Analysis of Financial Condition and Results of Operations

11

Item 4:  Controls and Procedures

 

14

PART II – OTHER INFORMATION

Item 1:  Legal Proceedings

16

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

16

Item 5:  Other Information

16

Item 6:  Exhibits

16

Signatures

17

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PART I — FINANCIAL INFORMATION

Item 1.  Financial Statements.

GENOSYS, INC.

(A Development Stage Company)

CONDENSED CONSOLIDATED BALANCE SHEETS

See accompanying notes to condensed consolidated financial statements.

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GENOSYS, INC. AND SUBSIDIARIES

(A Development Stage Company)

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

See accompanying notes to condensed consolidated financial statements.

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GENOSYS, INC.

(A Development Stage Company)

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

See accompanying notes to condensed consolidated financial statements.

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GENOSYS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

(1)

Interim Condensed Consolidated Financial Statements

The accompanying condensed consolidated financial statements of GeNOsys, Inc. (the “Company”) have been prepared without audit, pursuant to the rules and regulations of the Security and Exchange Commission. In the opinion of management, all adjustments (consisting of normal recurring adjustments) necessary to present fairly the Company’s consolidated financial position, results of operations and cash flows as of the dates and for the periods presented herein have been made.  

Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted pursuant to the Securities and Exchange Commission’s rules and regulations. These condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s November 30, 2010 Annual Report on Form 10-K. The results of operations for the three and nine month periods ended August 31, 2011, are not necessarily indicative of the operating results that may be expected for the year ending November 30, 2011. The Company’s significant accounting policies are set forth in Note 1 to the consolidated financial statements in the November 30, 2010 Annual Report on Form 10-K.

The Company’s working capital requirements for the foreseeable future will vary based upon a number of factors, including the costs to complete development work, the cost of bringing its products to commercial viability, the timing of the market launches of its products and the level of sales after introduction into the market place.  As of August 31, 2011, the Company had accounts payable and accrued liabilities totaling $1,252,032.  At August 31, 2011, the Company had cash and cash equivalents $3,598.  Management knows that existing cash and cash equivalents will not be sufficient to meet the Company’s cash requirements during the next 12 months, and is actively engaged in efforts to raise additional funds.  However, there is no assurance that additional funding will be available on acceptable terms, if at all.  These circumstances raise substantial doubt about the ability of the Company to continue to operate.

(2)

Principles of Consolidation

The accompanying condensed consolidated financial statements include the accounts of GeNOsys, Inc. and its wholly-owned subsidiaries, GeNOsys, Inc., a Nevada corporation and Health Innovations Inc., a Utah corporation.  All significant intercompany accounts and transactions have been eliminated in consolidation.

(3)

Recent Accounting Pronouncements

Fair Value Measurement – In April 2011, the Financial Accounting Standards Board (“FASB”) issued new guidance to achieve common fair value measurement and disclosure requirements between GAAP and International Financial Reporting Standards.  This new guidance amends current fair value measurement and disclosure guidance to include increased transparency around valuation inputs and investment categorization.  The new guidance is effective for fiscal years and interim periods beginning after December 15, 2011.  The Company does not believe the adoption of the new guidance will have an impact on its consolidated financial position, results of operations or cash flows.

Comprehensive Income – In June 2011, the FASB issued new guidance on the presentation of comprehensive income.  Specifically, the new guidance allows an entity to present components of net income or other comprehensive income in one continuous statement, referred to as the statement of comprehensive income, or in two separate, but consecutive statements.  The new guidance eliminates the current option to report other comprehensive income and its components in the statement of changes in equity. While the new guidance changes the presentation of comprehensive income, there are no changes to the components that are recognized in net income or other comprehensive income under current accounting guidance.  This new guidance is effective for fiscal years and interim periods beginning after December 15, 2011.  The Company does not believe the adoption of the new guidance will have an impact on its consolidated financial position, results of operations or cash flows.

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(4)

Stock-Based Compensation

On March 23, 2007, the GeNOsys, Inc. 2007 Stock Option Plan (“Stock Plan”) was approved by the Board of Directors and became effective on that date.  The Stock Plan provides that 3,000,000 shares of the Company’s authorized but unissued common stock be reserved pursuant to the terms and conditions of the plan.  On June 27, 2007, the annual meeting of stockholders was held, at which time the stockholders approved the Stock Plan.  The Stock Plan allows the Company, under the direction of the Compensation Committee, to make broad-based grants of stock options, any of which may or may not require the satisfaction of performance objectives, to employees, consultants and non-employee directors.   In June and July 2007, the Board of Directors approved stock option grants to purchase 1,100,000 shares of common stock to certain employees, directors and consultants, resulting in a non-cash charge of $574,321.  In November and December 2007, the Board of Directors approved addition grants of 700,000 options to an employee and a director, resulting in a non-cash charge of $329,335.  In December 2008, the Board of Directors approved an option grant to purchase 900,000 shares of common stock to a certain employee and a director of the Company resulting in a non-cash charge of $151,900.  During 2010 our directors approved the grant of 588,542 stock option grants to a certain employee, resulting in a non-cash charge of $32,054.  The charges are being expensed ratably over the shorter of the vesting period or the requisite service period of the stock option grants.  To date in 2011, 1,100,000 of the previously granted stock options were forfeited; 200,000 of the previously granted stock options were forfeited in 2010.

A summary of the status of the Company’s option plans as of December 1, 2010, and changes during the nine months ended August 31, 2011, is presented below:

	Shares		Wtd. Avg. Exercise Prices		Wtd. Avg. Remaining Contractual Life				Intrinsic Value
Outstanding at November 30, 2010		3,088,542		$  0.42		5.83 years
Granted		-
Forfeited		(1,100,000)		$  0.70
Outstanding at August 31,       2011		1,988,542		$  0.27		5.83 years		-
Exercisable at August 31,    2011		1,788,542		$  0.28		5.82 years		-
Non-vested at August 31,    2011		200,000		$  0.20		5.82 years		-

The following table summarizes information about stock options outstanding at August 31, 2011:

 

		Options Outstanding				Options Exercisable
Range of Exercise Prices	Number Outstanding as of August 31, 2011		Wtd. Avg. Remaining Contractual Life	Wtd. Avg. Exercise Price	Number Exercisable as of August 31, 2011		Wtd. Avg. Exercise Price
$      0.04	156,250		5.82 years	$         0.04	156,250		$        0.04
$      0.05	250,000		5.82 years	$         0.05	250,000		$        0.05
$      0.06	104,167		5.82 years	$         0.06	104,167		$        0.06
$      0.08	78,125		5.82 years	$         0.08	78,125		$        0.08
$      0.20	900,000		5.82 years	$         0.20	700,000		$        0.20
$          0.66	500,000		5.83 years	$         0.66	500,000		$        0.66
	1,988,542			$         0.27	1,788,542		$        0.28

The fair value of each option granted is estimated on the date of grant using the Black-Scholes option pricing model.   The use of this valuation model requires the use of accounting judgment and financial estimates, including estimates of the expected term employees will retain their vested options before exercising them, the estimated volatility of our stock price, and the number of options that will be forfeited prior to the completion of their vesting requirements.  Application of alternative assumptions could produce significantly different estimates of the fair value of stock-based compensation and consequently, the related amounts recognized in our statements of operations.  The following weighted-average assumptions used for grants:  Grants made in June, July and November, 2007: average risk-free interest rate of 5.25%; expected lives of 10 years; expected dividend yield of

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zero percent; expected volatility of 61.47% to 68.88%.  The grant made in December, 2007: risk-free interest rate of

3.89%; expected life of 6.5 years; expected dividend yield of zero percent; expected volatility of 62.75%.  The grant made in December 2008: risk-free interest rate of 3.89%; expected life of 6.5 years; expected dividend yield of zero percent; expected volatility of 112.14%.  The grant made in 2010:  risk-free interest rate of 3.04%; estimated life of 6.5 years; expected dividend yield of zero percent; expected volatility of 171.08%.  The Company used the simplified method to determine the expected term of the options due to the lack of historical data. Changes in these assumptions can materially affect the fair value estimate.  For the nine month periods ended August 31, 2011 and 2010, the Company recognized stock based compensation expense of $52,885 and $228,442, respectively.  As of August 31, 2011, total stock based compensation related to non-vested awards not yet recognized was $11,309 with a weighted average recognition period of 5.83 years.  As of August 31, 2010, total stock based compensation related to non-vested awards not yet recognized was $140,953 with a weighted average recognition period of 5.83 years.

(5)

Going Concern

The Company has accumulated losses since inception and has not yet been able to generate profits from operations.  Operating capital has been raised through the sale of common stock.  These factors raise substantial doubt about the Company’s ability to continue as a going concern.

Management plans include further development and production of portable, medical gas generators.  The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

(6)

Prepaid Expenses

Prepaid expenses consist primarily of payments made for consulting and professional fees which are expected to be utilized within the next 90 to 120 days.

(7)

Basic and Diluted Net Loss per Common Share

Both basic and diluted net loss per share for the periods ending August 31, 2011 and 2010 are based on the net operating loss for the period divided by the weighted average number of common shares outstanding for the period.  The Company’s common stock equivalents at period end were anti-dilutive and therefore excluded from the computation.

(8)

Related Party Transaction

During the nine months ended August 31, 2011 shareholders loaned the Company $158,085 to pay for expenses.

The Company has issued convertible notes payable to an officer for funds provided to the Company. The notes were issued December 4, 2009 through March 30, 2011, and currently total $227,180.  The notes bear interest at the rate of five percent per annum and, at the election of the holder, may be converted into shares of the Company’s restricted common stock at the lower of the market rate on the date notice of conversion is given or 125% of the closing price of the common stock on the date the note was issued.

(9)

Issuance of Stock:

Stock issued through Private Placement:

In January 2011 the Company sold 500,000 shares of its restricted common stock to an accredited investor through a private placement.  Net proceeds received by the Company were $10,000.

In April 2011 the Company sold 550,000 shares of its restricted common stock to accredited investors through a private placement.  Net proceeds received by the Company were $27,500.

In May 2011 the Company sold 2,100,000 shares of its restricted common stock to accredited investors through a private placement.  Net proceeds received by the Company were $105,000.

In August 2011, the Company sold 250,000 shares of its restricted common stock to an accredited investor through a private placement.  Net proceeds received by the Company were $12,500.

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Stock issued for Notes:

In July 2011 the Company issued 4,000,000 shares of its restricted common stock in consideration for convertible notes with a principal of $200,000 and accrued interest of $11,819.

In August 2011, the Company issued 1,000,000 shares of its restricted common stock in consideration for convertible notes with a principal of $50,000 and accrued interest of $2,979.

Stock issued for Services:

In January 2011 the Company issued 2,782,817 shares of restricted stock for services.  Of the total, 1,500,000 shares were issued to directors of the Company and 1,282,817 shares were issued to consultants.  These shares are fully vested and non-forfeitable.  The Company valued these share issuances at $55,656 which it expensed during the period ended February 28, 2011.  The valuation was based on the closing price of $0.02 per share on the date of grant.  

In June 2011, the Company issued 400,000 shares of restricted stock for services.  These shares are fully vested and non-forfeitable.  The Company valued these shares issuances at $20,000 which was expensed during the current period.  The valuation was based on the closing price of $0.05 per share on the date of the grant.

Stock granted:

In May 2011 the Board of Directors approved the issuance of 8,500,000 shares of restricted common stock to a director and 3,000,000 shares of restricted common stock to a former employee in consideration for consulting services, the assignment of certain patents, the cancellation of stock options, providing an indemnity, and for accrued liabilities.  The stock vested upon the date of grant.  The transaction resulted in the allocation of $141,950 to patents, a $278,332 reduction of accrued liabilities, and a stock-based compensation charge of $23,843, which charge was recorded as a non-cash expense in May 2011.  The Company valued this transaction based on the fair value of the stock issued, as it was more readily determinable.

 (10)

Commitments and Contingencies

The Company is making payments of $7,500 per month under an agreement reached to retire the amount owed to Riverwoods Medical Arts for the offices which it vacated.  At August 31, 2011, there is a balance of approximately $56,031 owing under this agreement.

The Company has also accrued $120,000 in fees to be paid to a director contingent upon the Company achieving profitability.

(11)

Subsequent Events

In September 2011 the Company signed two license agreements with Equity Labs Inc. for the manufacture and sale of its topical products.  The first license agreement is an exclusive license for an acne product; the second license agreement is a non-exclusive license for a line of personal care products.

In November 2011 the Company agreed to assume liability for $175,000 of a $500,000 convertible note issued by a director of the Company.  The $175,000 assumed was in exchange for an equivalent $175,000 which the Company owed to the director at August 31, 2011.  The note carries an interest rate of ten percent and has a maturity date of December 1, 2014.  At the option of the Note Holder, the principal and interest may be converted into restricted common stock of the Company at a conversion rate of $0.03 per share.

[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]

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

The following discussion and analysis provides information which management believes is relevant to an assessment and understanding of our condensed consolidated results of operations and financial condition. The discussion should be read in conjunction with the consolidated financial statements included in our Form 10-K Annual Report for the year ended November 30, 2010, and notes thereto.

Overview

Nitric Oxide Gas for Inhalation

We are a medical research and development company specializing in pharmaceutical, bio-technical and medical gas generating systems.  The primary gas our systems will generate is medical grade nitric oxide, along with other various combinations of beneficial medical gases suitable for the treatment of human conditions and diseases. The gases also have other potential uses, such as the treatment of animals by veterinarians and the sterilization of equipment and devices.

     

Non-medical grade nitric oxide gas is produced and sold commercially by major gas companies as a specialty gas mixture and calibration gas.  Nitrogen dioxide is present in all nitric oxide gas currently produced.  Its presence limits the size of the dose of nitric oxide gas that can be administered for prospective uses in both humans and animals.

     

We have developed a proprietary compound formulation that will be utilized to produce medical grade nitric oxide gas in our desktop and portable generators.  Management believes that with the further refinement of our proprietary formulation, we can make or filter medical grade nitric oxide gas with minimal amounts of nitrogen dioxide, and that this process can produce medical grade nitric oxide gas in ample quantities for any current or prospective use and at a price substantially less than that of all currently available technologies.

     

Our current generator models are capable of delivering sufficient quantities of nitric oxide gas for individual laboratory desktop use. We are continuing to further develop our generators and our proprietary compound formulation for high production quantities and consistency.  The product must have a known shelf life and be available in various configurations to produce known concentrations and volumes of gas.  Packaging is another critical developmental process that we are addressing. Management plans to rely on outside contractors to achieve these objectives.

     

We estimate that non-clinical laboratory sales could take place earlier than United States Food and Drug Administration (“FDA”) approval. Management anticipates that selling our desktop generator earlier into the market as laboratory equipment will pave the way for sales of our medical generators and proprietary tablets and compounds, but expected financial contributions from non-medical generator and tablet sales will not be sufficient to fund the substantial costs of the FDA approval process for human medical uses.  We expect that contributions from laboratory sales will be able to cover all or part of our manufacturing and set-up costs and contribute to our overall profitability in due time, but believe that we will also require additional funding, which we are currently working to secure.  

     

All human medical uses of nitric oxide gas require FDA approval prior to initiating sales in the United States, and the approval of similar international agencies in their respective countries.  Approval can be a long and expensive process, with no assurance that any such approval can or will ever be obtained.  Management hopes to reduce the time for regulatory approval by certain strategic approaches that are proprietary.

    

 Our objectives are to establish GeNOsys (generated nitric oxide systems) as the premier nitric oxide generating pharmaceutical company and to:

·

manufacture and sell medical grade nitric oxide generators and tablets and compounds for use in the relief of human diseases;

·

offer value added services such as custom generators adapted for the treatment of various diseases;

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·

hire staff both currently identified and unidentified to implement our business model; and  

·

obtain FDA approval of our generating systems.

         

     Nitric Oxide Producing Topical Products

We have developed a group of nitric oxide producing products for topical use.  Patent applications have been filed for these products, which will be available as a cream, gel or wash, depending on the desired application and use.

There are significant markets for topical nitric oxide producing products, including use on non-healing wounds (diabetic ulcers, etc.) and skin care (acne, rashes, abrasions, etc.).  For use on non-healing wounds, nitric oxide producing topical products will, with their vasodilator properties, support blood flow to the wound area and support collagen growth, with their anti-inflammatory properties they will reduce inflammation in the wound area, and with their antibacterial properties, support the body in clearing the wound area of infection.  We are currently working with a wound care clinic to finalize the procedures for use on non-healing wounds.  It is anticipated that revenues will begin to be generated from these topical nitric oxide producing products during the fourth quarter of 2011.

Results of Operations

The following table presents our results of operations for the three and nine months ended August 31, 2011, and August 31, 2010:

		For the Three Months				For the Nine Months
		Ended				Ended
		August 31, 2011		August 31, 2010		August 31, 2011		August 31, 2010
Revenues	$	-	$	-	$	-	$	-
Cost of sales		-		-		-		-
Gross margin		-		-		-		-
Operating expenses:
Research and development		365,964		192,560		529,014		646,393
General and administrative		99,487		131,810		319,963		434,661
Gain (Loss) on disposal of asset		-		-		-		6,140
Total operating expenses		465,451		324,370		848,977		1,087,194
Net income (loss) from operations		(465,451)		(324,370)		(848,977)		(1,087,194)
Other income (expense):
Interest expense		(5,979)		(7,243)		(19,827)		(19,900)
Total other income (expense), net		(5,979)		(7,243)		(19,827)		(19,900)
Provision for income tax		-		-		-		100
Net income (loss)	$	(471,430)	$	(331,613)	$	(868,804)	$	(1,107,194)

For the Three Months Ended August 31, 2011 and 2010

During the three-month period ended August 31, 2011, we had a net loss of $471,430.  This compares to a net loss of $331,613 for the comparable period ended August 31, 2010.  Net loss per common share for these periods was $(.01) and $(.01), respectively.  

Research and development (“R&D”) expenses were $365,964 and $192,560, respectively, for the three-month periods ended August 31, 2011 and 2010, an increase of $173,404.   The increase results primarily from increases in consulting fees, offset in part by reductions in stock-based compensation, advisory board fees, building rent,

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salaries and benefits, and smaller reductions in a number of other expense categories. Consulting fees will continue at a high level as work to finalize the controller module for the nitric oxide generator continues during the fourth quarter. As the documentation, preparation and regulatory work for FDA approval intensifies, R&D expenses are expected to grow in future periods.

General and administrative (“G&A”) expenses were $99,487 and $131,810, respectively, for the three-month periods ended August 31, 2011 and 2010.  The decrease of $32,323 resulted primarily from reductions in stock-based compensation charges, offset by smaller increases and decreases in a number of other expense categories.  We expect that for the remainder of 2011, general and administrative expenses will be somewhat higher than those experienced for the current quarter.

Total other expense was $5,979 in the three-month period ended August 31, 2011 compared to other expense of $7,243 for the three-month period ended August 31, 2010.  The $1,264 decrease resulted from a part of the loans payable and their related interest being converted into restricted common stock during the period.

For the Nine Months Ended August 31, 2011 and 2010

During the nine-month period ended August 31, 2011, we had a net loss of $868,804.  This compares to a net loss of $1,107,194 for the comparable period ended August 31, 2010.  Net loss per common share for these periods was $(.01) and $(.02), respectively.  

R&D expenses were $529,014 and $646,393, respectively, for the nine-month periods ended August 31, 2011 and 2010, a decrease of $117,379.   The decrease in research and development expenditures results from reductions in consulting and advisory fees, stock-based compensation, building rent, salaries and travel expenses.  We expect that as the work to finalize the analyzer intensifies, R&D expenses will increase in the remaining period of 2011.

G&A expenses were $319,963 and $434,661, respectively, for the nine-month periods ended August 31, 2011 and 2010.  The $114,698 decrease results from decreases in stock-based compensation charges, legal fees and building rent, offset in part by increases in directors fees, consulting fees and smaller increases and decreases in a number of other accounts.  It is expected that expenses for the final quarter of the year will be somewhat higher than those levels experienced to date.

Total other expense was $19,827 in the nine-month period ended August 31, 2011 compared to other expense of $19,900 for the nine-month period ended August 31, 2010.  These are interest expenses related to the loans payable the Company secured to provide operating funds.

Financial Position

We had $3,598 in cash and cash equivalents as of August 31, 2011, representing a decrease of $23,569 from November 30, 2010.  Working capital as of August 31, 2011, was a deficit of $1,246,368 compared to a deficit of $1,246,202 as of November 30, 2010.

Liquidity and Capital Resources

To date, we have financed our operations principally through private placements of our equity securities. Net cash of $177,217 was used for operating activities during the nine months ended August 31, 2011, a decrease of $430,370 as compared to the $607,587 used during the same period ended August 31, 2010.  Also, during the nine months ended August 31, 2011, net cash of $21,170 was used for the purchase of intangible assets.  This compares with $21,310 used for the purchase of intangible assets and computer equipment for the same period ended August 31, 2010.   As of August 31, 2011, our current liabilities totaled $1,252,032, and we had a working capital deficit of $1,246,368.  As of August 31, 2011, we had no long-term debt obligations.  

Our working capital requirements for the foreseeable future will vary based upon a number of factors, including the costs to complete development work, the cost of bringing our nitric oxide generator and nitric oxide tablets to commercial viability, the costs associated with obtaining FDA approval, the timing of the market launches of our products and the level of sales of those products when introduced into the market place.  As of August 31, 2011, we had accounts payable and accrued liabilities totaling $1,252,032.  At August 31, 2011, we had cash and cash equivalents of $3,598.  We know that existing cash and cash equivalents will not be sufficient to execute our business plan, or to meet our cash requirements during the next 12 months, and we are currently actively working to raise additional funds.  However, there can be no assurance that additional funding will be available on favorable

terms, if at all.  If we fail to obtain additional funding when needed, our business and financial condition may be adversely affected.

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Critical Accounting Policies

Recent Accounting Pronouncements.

Fair Value Measurement – In April 2011, the Financial Accounting Standards Board (“FASB”) issued new guidance to achieve common fair value measurement and disclosure requirements between GAAP and International Financial Reporting Standards.  This new guidance amends current fair value measurement and disclosure guidance to include increased transparency around valuation inputs and investment categorization.  The new guidance is effective for fiscal years and interim periods beginning after December 15, 2011.  We do not believe the adoption of the new guidance will have an impact on our consolidated financial position, results of operations or cash flows.

Comprehensive Income – In June 2011, the FASB issued new guidance on the presentation of comprehensive income.  Specifically, the new guidance allows an entity to present components of net income or other comprehensive income in one continuous statement, referred to as the statement of comprehensive income, or in two separate, but consecutive statements.  The new guidance eliminates the current option to report other comprehensive income and its components in the statement of changes in equity. While the new guidance changes the presentation of comprehensive income, there are no changes to the components that are recognized in net income or other comprehensive income under current accounting guidance.  This new guidance is effective for fiscal years and interim periods beginning after December 15, 2011.  We do not believe the adoption of the new guidance will have an impact on our consolidated financial position, results of operations or cash flows.     

Inflation

We do not expect the impact of inflation on our operations to be significant for the next twelve months.

Forward-Looking Statements

This Form 10-Q contains forward-looking statements within the meaning of the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended.  Statements made in this Quarterly Report which are not purely historical are forward-looking statements with respect to our goals, plan objectives, intentions, expectations, financial condition, results of operations, future performance and business, including, without limitation, (i) our ability to raise capital, and (ii) statements preceded by, followed by or that include the words “may”, “would”, “could”, “expects”, “projects”, “anticipates”, “believes”, “estimates”, “plans”, “intends”, “targets” or similar expressions.

Forward-looking statements involve inherent risks and uncertainties, and important factors (many of which are beyond our Company’s control) that could cause actual results to differ materially from those set forth in the forward-looking statements, including the following:  general economic or industry conditions, nationally and/or in the communities in which we conduct business, changes in the interest rate environment, legislation or regulatory requirements, conditions of the securities markets, our ability to raise capital, changes in accounting principles, policies or guidelines, financial or political instability, acts of war or terrorism, other economic, competitive, governmental, and regulatory and technical factors affecting our operations, products, services and prices.

Unless otherwise required by applicable law, we do not undertake, and specifically disclaim any obligation, to update any forward-looking statements to reflect occurrences, developments, unanticipated events or circumstances after the date of such statement.

Item 4.  Controls and Procedures

As of the end of the period covered by this Quarterly Report, we carried out an evaluation, under the supervision and with the participation of our Chief Executive Officer and Chief/Principal Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures.  Based upon this evaluation, our Chief Executive Officer and Chief/Principal Financial Officer determined whether the information required to be disclosed is recorded, processed, summarized and reported within the specified periods, and is accumulated and communicated to management, including our Chief Executive Officer and Chief/Principal Financial Officer to allow for timely decisions regarding required disclosure of material information required to be included in our periodic reports filed with the Securities and Exchange Commission.  As the information was not communicated in such manner, we were unable to file our quarterly report timely.  Our disclosure controls and procedures are designed to provide

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reasonable assurance of achieving their objectives and our Chief Executive Officer and Chief/Principal Financial Officer have concluded that our disclosure controls and procedures were not effective to a reasonable assurance level of achieving such objectives.  However, it should be noted that the design of any system of controls is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions, regardless of how remote.  

There were no changes in our internal control over financial reporting during the period covered by this Quarterly Report.

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PART II — OTHER INFORMATION

Item 1.  Legal Proceedings.

               On August 22, 2011, the Company received notice of a suit filed in the Fourth District Court in the State of Utah by a former employee.  The action alleges unpaid wages of $23,752.35 and seeks damages for loss of medical insurance benefits.  The Company filed an answer on September 15, 2011, denying the allegations made.          

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

None.

Item 5.  Other Information.

None.

Item 6.  Exhibits.

(a)

Exhibit Index

EXHIBIT INDEX

Exhibit No.              Description of Exhibit                           

3.1

Articles of Incorporation (Incorporated by reference to our Registration Statement on Form 10-SB filed May 14, 2002).

3.2

By-laws (Incorporated by reference to our Registration Statement on Form 10-SB filed May 14, 2002).

3.3

Amendment to the Articles of Incorporation dated September 12, 2005 (Incorporated by reference to Exhibit 3.3 of our Form 10-KSB, dated November 30, 2005).

3.4

Amendment to the By-Laws dated June 18th, 2004 (Incorporated by reference to Exhibit 3.4 of our Form 10-KSB, dated November 30, 2005).

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Code of Ethics (Incorporated by reference to Exhibit 14 of our Form 10-KSB, dated November 30, 2005).

21

Subsidiaries (Incorporated by reference to Exhibit 21 of our Form 10-KSB, dated November 30, 2005).

Registration statement on Form 10-SB filed May 14, 2002, as amended on September 10, 2002, November 19, 2002 and December 9, 2002*

Annual Report on Form 10KSB for the year ended November 30, 2005 and filed on March 7, 2006*

Annual Report on Form 10KSB for the year ended November 30, 2006 and filed on March 15, 2007*

Current Report on Form 8-K dated January 22, 2008 and filed February 12, 2008*

Annual Report on form 10-KSB for the year ended November 30, 2007 and filed on February 28, 2008*

Annual Report on form 10-KSB for the year ended November 30, 2008 and filed on March 16, 2009*

Annual Report on form 10-KSB for the year ended November 30, 2009 and filed on March 1, 2010*

Annual Report on form 10-KSB for the year ended November 30, 2010 and filed on March 15, 2011*

*   Referenced for additional information.

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31.1

Certification of Dale L. Fillmore under Section 302 of the Sarbanes-Oxley Act of 2002.

31.2

Certification of Keith L. Merrell under Section 302 of the Sarbanes-Oxley Act of 2002.

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          Certification of Dale L. Fillmore and Keith L. Merrell pursuant to 18 U.S.C. Section 1350, as Adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

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 hereunto duly authorized.

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