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TENAX THERAPEUTICS, INC. - Quarter Report: 2012 October (Form 10-Q)

oxbt_10q.htm
 


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
 
FORM 10-Q
 
þ
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
FOR THE QUARTERLY PERIOD ENDED October 31, 2012
 
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 001-34600
 
 
OXYGEN BIOTHERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
 
Delaware
 
26-2593535
(State or other jurisdiction of incorporation
or organization)
 
(I.R.S. Employer Identification No.)
 

ONE Copley Parkway, Suite 490, Morrisville, North Carolina
(Address of principal executive offices)
 
27560
(Zip Code)
 
(919) 855-2120
(Registrant’s telephone number, including area code)
 
 
Indicate by check mark 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, 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
¨
Accelerated filer
¨
Non-accelerated filer
¨
Smaller reporting company
þ
       
(Do not check if a smaller reporting company)
     
 
Indicate by check mark whether the registrant is a shell company (as defined by Rule 12b-2 of the Exchange Act).    Yes   ¨     No   þ
 
As of December 12, 2012, the registrant had outstanding 33,133,895 shares of Common Stock.
 


 
 
 

 
 
TABLE OF CONTENTS
 
 
     
PAGE
 
PART I. FINANCIAL INFORMATION
     
Item 1.
Financial Statements
    3  
 
Balance Sheets (Unaudited) as of October 31, 2012 and April 30, 2012
    3  
 
Statements of Operations (Unaudited) for the Three and Six Months Ended October 31, 2012 and 2011
    4  
 
Statements of Cash Flows (Unaudited) for the Six Months Ended October 31, 2012 and 2011
    5  
 
Notes to Financial Statements
    7  
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
    20  
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
    33  
Item 4.
Controls and Procedures
    34  
           
PART II. OTHER INFORMATION
       
Item 1.
Legal Proceedings
    35  
Item 1A.
Risk Factors
    35  
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
    36  
Item 3.
Defaults Upon Senior Securities
    36  
Item 4.
Mine Safety Disclosures
    36  
Item 5.
Other Information
    37  
Item 6.
Exhibits
    37  

 
 
2

 
 
PART I - FINANCIAL INFORMATION
 
 
ITEM 1.
FINANCIAL STATEMENTS
 
OXYGEN BIOTHERAPEUTICS, INC.
(a development stage enterprise)
BALANCE SHEETS

   
October 31, 2012
   
April 30, 2012
 
   
(Unaudited)
       
             
ASSETS
           
Current assets
           
Cash and cash equivalents
  $ 1,511,513     $ 1,879,872  
Accounts receivable
    17,193       13,385  
Government grant receivable
    42,306       35,650  
Inventory
    109,357       83,370  
Prepaid expenses
    291,359       455,946  
Other current assets
    145,195       162,809  
Total current assets
    2,116,923       2,631,032  
Property and equipment, net
    247,525       293,606  
Debt issuance costs, net
    214,351       278,659  
Intangible assets, net
    904,498       872,971  
Other assets
    58,262       65,666  
Total assets
  $ 3,541,559     $ 4,141,934  
                 
LIABILITIES AND STOCKHOLDERS’ DEFICIT
               
Current liabilities
               
Accounts payable
  $ 479,300     $ 542,809  
Accrued liabilities
    428,817       1,273,837  
Convertible preferred stock
    429,978       1,247,266  
Current portion of notes payable, net
    7,195       62,958  
Total current liabilities
    1,345,290       3,126,870  
Other liabilities
    76,524       -  
Long-term portion of notes payable, net
    2,177,776       1,361,110  
Total liabilities
    3,599,590       4,487,980  
                 
                 
Commitments and contingencies; see Note 7.
               
Stockholders' deficit
               
 Preferred stock, undesignated, authorized 9,992,500 shares; see Note 5.
    -       -  
Common stock, par value $.0001 per share; authorized 400,000,000 shares; issued and outstanding 32,899,900 and 29,417,718,  respectively
    3,290       2,942  
Additional paid-in capital
    112,710,782       107,279,296  
Deficit accumulated during the development stage
    (112,772,103 )     (107,628,284 )
Total stockholders’ deficit
    (58,031 )     (346,046 )
Total liabilities and stockholders' deficit
  $ 3,541,559     $ 4,141,934  
                 

 

 
3

 
OXYGEN BIOTHERAPEUTICS, INC.
(a development stage enterprise)
STATEMENTS OF OPERATIONS

    Period from
May 26, 1967 (Inception) to
 October 31,
   
Three months ended October 31,
   
Six months ended October 31,
 
             
    2012    
2012
   
2011
   
2012
   
2011
 
    (Unaudited)     (Unaudited)     (Unaudited)     (Unaudited)     (Unaudited)  
Product revenue
  $ 496,282     $ 14,571     $ 27,415     $ 26,028     $ 86,892  
Cost of sales
    324,512       9,134       10,500       15,044       45,104  
Net product revenue
    171,770       5,437       16,915       10,984       41,788  
Government grant revenue
    1,090,499       509,435       78,244       775,984       78,244  
Total net revenue
    1,262,269       514,872       95,159       786,968       120,032  
                                         
Operating expenses
                                       
Selling, general, and administrative
    48,594,699       422,843       1,660,810       1,685,632       3,461,799  
Research and development
    23,317,158       604,574       488,577       1,241,846       1,140,538  
Restructuring expense
    217,774       170,298       -       217,774       -  
Loss on impairment of long-lived assets
    363,691       -       -       -       -  
Total operating expenses
    72,493,322       1,197,715       2,149,387       3,145,252       4,602,337  
                                         
Net operating loss
    71,231,053       682,843       2,054,228       2,358,284       4,482,305  
                                         
Interest expense
    42,516,990       867,524       871,768       2,793,427       1,307,566  
Loss on extinguishment of debt
    250,097       -       -       -       -  
Other expense (income)
    (1,226,037 )     6,911       3,927       (7,892 )     9,121  
Net loss
  $ 112,772,103     $ 1,557,278     $ 2,929,923     $ 5,143,819     $ 5,798,992  
                                         
Net loss per share, basic
          $ (0.05 )   $ (0.12 )   $ (0.17 )   $ (0.25 )
Weighted average number of common shares outstanding, basic
      32,074,192       23,805,323       31,161,511       23,604,502  
Net loss per share,  diluted
          $ (0.13 )   $ (0.29 )   $ (0.24 )   $ (0.42 )
Weighted average number of common shares outstanding, diluted
      34,249,083       25,980,214       33,336,402       25,081,668  
 
 
4

 
OXYGEN BIOTHERAPEUTICS, INC.
(a development stage enterprise)
STATEMENTS OF CASH FLOWS

    Period from May 26, 1967(Inception) to October 31, 2012    
Six months ended October 31,
 
         
       
2012
   
2011
 
    (Unaudited)     (Unaudited)     (Unaudited)  
CASH FLOWS FROM OPERATING ACTIVITIES
                 
Net Loss
  $ (112,772,103 )   $ (5,143,819 )   $ (5,798,992 )
Adjustments to reconcile net loss to net cash used in operating activities
                 
Depreciation and amortization
    2,144,580       73,772       118,864  
Amortization of deferred compensation
    336,750       -       -  
Interest on debt instruments
    42,108,805       2,792,811       1,295,541  
Loss on debt settlement and extinguishment
    163,097       -       -  
Loss on impairment, disposal and write down of long-lived assets
    802,736       11,563       2,671  
Issuance and vesting of compensatory stock options and warrants
    8,342,633       51,972       50,905  
Issuance of common stock below market value
    695,248       -       -  
Issuance of common stock as compensation
    828,564       146,038       51,338  
Issuance of common stock for services rendered
    1,265,279       -       -  
Issuance of note payable for services rendered
    120,000       -       -  
Contributions of capital through services rendered by stockholders
    216,851       -       -  
Changes in operating assets and liabilities
                       
Accounts receivable, prepaid expenses and other assets
    (595,463 )     198,074       (171,416 )
Inventory
    200,365       (30,381 )     (19,629 )
Accounts payable and accrued liabilities
    1,100,291       (841,845 )     (112,736 )
Net cash used in operating activities
    (55,042,367 )     (2,741,815 )     (4,583,454 )
                         
CASH FLOWS FROM INVESTING ACTIVITIES
                       
Purchase of property and equipment
    (1,774,462 )     (12,719 )     (8,869 )
Proceeds from the sale of property and equipment
    4,243       -       -  
Capitalization of patent costs and license rights
    (1,820,138 )     (58,062 )     (152,606 )
Net cash used in investing activities
    (3,590,357 )     (70,781 )     (161,475 )
                         
CASH FLOWS FROM FINANCING ACTIVITIES
                       
Proceeds from sale of common stock and exercise of stock options and warrants, net of related expenses and payments
    44,478,293       -       619,181  
Repurchase of outstanding warrants
    (2,836,520 )     -       -  
Proceeds from stockholder notes payable
    977,692       -       -  
Proceeds from issuance of notes payable, net of issuance costs
    7,518,521       -       700,000  
Proceeds from convertible notes, net of issuance costs
    13,321,447       -       4,514,161  
Proceeds for issuance of convertible preferred stock
    6,000,000       2,500,000       -  
Payments on notes - short-term
    (1,315,196 )     (55,763 )     (36,100 )
Payments on notes - long-term
    (8,000,000 )     -       -  
Net cash provided by financing activities
    60,144,237       2,444,237       5,797,242  
                         
Net change in cash and cash equivalents
    1,511,513       (368,359 )     1,052,313  
Cash and cash equivalents, beginning of period
    -       1,879,872       951,944  
Cash and cash equivalents, end of period
  $ 1,511,513     $ 1,511,513     $ 2,004,257  
                         
Cash paid for:
                       
Interest
  $ 265,919     $ 616     $ 12,025  
Income taxes
  $ 27,528     $ -     $ -  
 
 
 
5

 
 
OXYGEN BIOTHERAPEUTICS, INC.
(a development stage enterprise)
STATEMENT OF CASH FLOWS, Continued
 
Non-cash financing activities during the six months ended October 31, 2012:
 
(1)
The Company issued 165,744 shares of restricted common stock for the payment of interest accrued on convertible notes. The shares were issued at a conversion price of $2.255 for the payment of $373,750 interest payable on convertible notes with a gross carrying value of $4,900,000.
 
(2)
The Company issued 3,132,017 shares of its common stock to redeem 3,281 shares of convertible preferred stock with a fair value of $3,981,935.
 
Non-cash financing activities during the six months ended October 31, 2011:
 
(1)
The Company issued 7,333 shares of common stock for the cashless exercise of 40,000 stock options with an exercise price of $1.96.
 
(2) 
The Company issued 78,197 shares of restricted common stock for the payment of interest accrued on convertible notes. The shares were issued at a conversion price of $2.255 for the payment of $176,333 interest payable on convertible notes with a gross carrying value of $4,600,000.

 

 
6

 
 

OXYGEN BIOTHERAPEUTICS, INC.
(a development stage enterprise)
NOTES TO FINANCIAL STATEMENTS
(Unaudited)

NOTE 1. DESCRIPTION OF BUSINESS
 
Oxygen Biotherapeutics, Inc. (the “Company”) was originally formed as a New Jersey corporation in 1967 under the name Rudmer, David & Associates, Inc., and subsequently changed its name to Synthetic Blood International, Inc. On June 17, 2008, the stockholders of Synthetic Blood International approved the Agreement and Plan of Merger dated April 28, 2008, between Synthetic Blood International and Oxygen Biotherapeutics, Inc., a Delaware corporation. Oxygen Biotherapeutics was formed on April 17, 2008, by Synthetic Blood International to participate in the merger for the purpose of changing the state of domicile of Synthetic Blood International from New Jersey to Delaware. Certificates of Merger were filed with the states of New Jersey and Delaware and the merger was effective June 30, 2008. Under the Plan of Merger, Oxygen Biotherapeutics is the surviving corporation and each share of Synthetic Blood International common stock outstanding on June 30, 2008 was converted to one share of Oxygen Biotherapeutics common stock.
 
Going Concern
 
The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”), which contemplate continuation of the Company as a going concern. The Company has an accumulated deficit during the development stage of $112.8 million as of October 31, 2012, and stockholders’ deficit of $58,031 and $346,046 as of October 31, 2012 and April 30, 2012, respectively. The Company requires substantial additional funds to complete clinical trials and pursue regulatory approvals. Management is actively seeking additional sources of equity and/or debt financing; however, there is no assurance that any additional funding will be available on commercially acceptable terms, or at all.
 
In view of the matters described above, recoverability of a major portion of the recorded asset amounts shown in the accompanying October 31, 2012 balance sheet is dependent upon continued operations of the Company, which in turn is dependent upon the Company’s ability to meet its financing requirements on a continuing basis, to maintain present financing, and to generate cash from future operations. These factors, among others, raise substantial doubt about the Company’s ability to continue as a going concern. The 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 in existence.
 
NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
 
Basis of Presentation
 
The Company has prepared the accompanying interim financial statements in accordance with GAAP for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, these financial statements and accompanying notes do not include all of the information and disclosures required by GAAP for complete financial statements. The financial statements include all adjustments (consisting of normal recurring adjustments) that management believes are necessary for the fair statement of the balances and results for the periods presented. These interim financial statement results are not necessarily indicative of the results to be expected for the full fiscal year or any future interim period.
 
Use of Estimates
 
In preparing the unaudited financial statements, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the dates of the unaudited financial statements and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from these estimates and the operating results for the interim periods presented are not necessarily indicative of the results expected for the full year.
 
On an ongoing basis, management reviews its estimates to ensure that these estimates appropriately reflect changes in the Company’s business and new information as it becomes available. If historical experience and other factors used by management to make these estimates do not reasonably reflect future activity, the Company’s results of operations and financial position could be materially impacted.
 
 
 
7

 
 
Net Loss per Share
 
Basic loss per share, which excludes antidilutive securities, is computed by dividing loss available to common shareholders by the weighted-average number of common shares outstanding for that particular period. In contrast, diluted loss per share considers the potential dilution that could occur from other equity instruments that would increase the total number of outstanding shares of common stock. Such amounts include shares potentially issuable under outstanding options, warrants, preferred stock and convertible notes. A reconciliation of the numerator and denominator used in the calculation of basic and diluted net loss per share follows:
 
   
Three months ended October 31,
   
Six months ended October 31,
 
   
2012
   
2011
   
2012
   
2011
 
Historical net loss per share:
                       
Numerator
                       
Net loss, as reported
  $ (1,557,278 )   $ (2,929,923 )   $ (5,143,819 )   $ (5,798,992 )
Less: Effect of amortization of interest expense on convertible notes
    (2,936,576 )     (4,637,024 )     (2,936,576 )     (4,637,024 )
Net loss attributed to common stockholders (diluted)
    (4,493,854 )     (7,566,947 )     (8,080,395 )     (10,436,016 )
Denominator
                               
Weighted-average common shares outstanding
    32,074,192       23,805,323       31,161,511       23,604,502  
Effect of dilutive securities
    2,174,891       2,174,891       2,174,891       1,477,166  
Denominator for diluted net loss per share
    34,249,083       25,980,214       33,336,402       25,081,668  
                                 
Basic net loss per share
  $ (0.05 )   $ (0.12 )   $ (0.17 )   $ (0.25 )
Diluted net loss per share
  $ (0.13 )   $ (0.29 )   $ (0.24 )   $ (0.42 )
 
The following outstanding options, warrants, preferred stock and convertible note shares were excluded from the computation of basic and diluted net loss per share for the periods presented because including them would have had an anti-dilutive effect.
 
   
Six months ended October 31,
 
   
2012
   
2011
 
             
Warrants to purchase common stock
    5,701,875       4,983,855  
Convertible preferred shares outstanding
    648,242       -  
Options to purchase common stock
    277,047       721,015  
Restricted stock grants
    75,672       -  
Convertible note shares outstanding
    1,942       -  
                 
 
Fair Value
 
The Company records its financial assets and liabilities in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 820 Fair Value Measurements.  The Company’s balance sheet includes the following financial instruments: cash and cash equivalents, short-term notes payable, convertible preferred stock and convertible notes. The Company considers the carrying amount of its cash and cash equivalents and short-term notes payable to approximate fair value due to the short-term nature of these instruments. The Company did not elect the fair value option and records the carrying value of its convertible notes at amortized cost in accordance with ASC 470-20.
 
Accounting for fair value measurements involves a single definition of fair value, along with a conceptual framework to measure fair value, with a fair value defined as “the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.” The fair value measurement hierarchy consists of three levels:
 
Level one
Quoted market prices in active markets for identical assets or liabilities;
Level two
Inputs other than level one inputs that are either directly or indirectly observable, and
Level three
Unobservable inputs developed using estimates and assumptions; which are developed by the reporting entity and reflect those assumptions that a market participant would use.

 
 
8

 
 
The Company applies valuation techniques that (1) place greater reliance on observable inputs and less reliance on unobservable inputs and (2) are consistent with the market approach, the income approach and/or the cost approach, and include enhanced disclosures of fair value measurements in the Company’s financial statements.
 
The following tables show information regarding assets and liabilities measured at fair value on a recurring basis as of October 31, 2012 and April 30, 2012:
 
         
Fair Value Measurements at Reporting Date Using
 
   
Balance as of
October 31, 2012
 
Quoted prices in Active Markets for Identical Securities (Level 1)
 
Significant Other Observable Inputs (Level 2)
 
Significant Unobservable Inputs (Level 3)
 
Current Assets
                       
Cash and cash equivalents
  $ 1,511,513     $ 1,511,513     $ -     $ -  
                                 
Current Liabilities
                               
Series A convertible preferred stock
  $ 429,978     $ -     $ -     $ 429,978  
                                 
                                 
                                 
                                 
           
Fair Value Measurements at Reporting Date Using
 
   
Balance as of
April 30, 2012
 
Quoted prices in Active Markets for Identical Securities (Level 1)
 
Significant Other Observable Inputs (Level 2)
 
Significant Unobservable Inputs (Level 3)
 
Current Assets
                               
Cash and cash equivalents
  $ 1,879,872     $ 1,879,872     $ -     $ -  
                                 
Current Liabilities
                               
Series A convertible preferred stock
  $ 1,247,266     $ -     $ -     $ 1,247,266  
 
There were no significant transfers between levels in the three months ended October 31, 2012.
 
The Preferred Stock is recorded at fair value with changes in fair value recorded as gains or losses within non-cash interest expense. The estimate of the fair value of the securities noted above, as of the valuation date, is based on the rights and privileges afforded to the Preferred Stock. The fair value of the Preferred Stock is determined at each reporting period by calculating the number of conversion shares underlying the outstanding Preferred Stock as described in the Series A Convertible Preferred Stock Certificate of Designations at the average volume weighted average price of the Company’s common stock on the valuation date (unobservable inputs).
 
The following table provides a summary of the changes in fair value of the Company’s financial liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) during the three months ended October 31, 2012:
 
   
Series A Convertible Preferred Stock
 
Balance as of April 30, 2012
  $ 1,247,266  
Issued on June 15, 2012
    2,500,000  
Conversions to Common Stock
    (3,520,940 )
Redemptions
    -  
Adjustments to fair value as of October 31, 2012
    203,652  
Transfers in and/or out of Level 3
    -  
Balance as of October 31, 2012
  $ 429,978  
         
 
 
 
9

 
 
Recent Accounting Pronouncements
 
On May 1, 2012, the Company adopted FASB Accounting Standards Update (“ASU”) 2011-05, Comprehensive Income (Topic 220): Presentation of Comprehensive Income. Under the amendments to Topic 220, Comprehensive Income, an entity has the option to present the total of comprehensive income, the components of net income, and the components of other comprehensive income either in a single continuous statement of comprehensive income or in two separate but consecutive statements. In both choices, an entity is required to present each component of net income along with total net income, each component of other comprehensive income along with a total for other comprehensive income, and a total amount for comprehensive income. This update eliminates the option to present the components of other comprehensive income as part of the statement of changes in stockholders’ equity. The amendments in this update do not change the items that must be reported in other comprehensive income or when an item of other comprehensive income must be reclassified to net income. The adoption of ASU 2011-05 did not have a material impact on the Company’s financial statements.
 
On May 1, 2012, the Company adopted ASU 2011-04, Fair Value Measurement (Topic 820): Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRSs. The amendments in this update result in common fair value measurement and disclosure requirements in GAAP and International Financial Reporting Standards (“IFRS”). Consequently, the amendments change the wording used to describe many of the requirements in GAAP for measuring fair value and for disclosing information about fair value measurements. The amendments in this update will not result in a change in the application of the requirements in Topic 820. The adoption of ASU 2011-04 did not have a material impact on the Company’s financial statements.
 
On July 27, 2012, the FASB issued ASU 2012-02, Testing Indefinite-Lived Intangible Assets for Impairment (the revised standard). The revised standard provides companies with an option to perform a “qualitative” assessment to determine whether further impairment testing is necessary. The qualitative assessment is not an accounting policy election and can be performed on none, some, or all of a company’s indefinite-lived intangible assets. ASU 2012-02 is effective on May 1, 2013 and early adoption is permitted. The Company does not believe adoption of ASU 2012-02 will have a material impact on its financial statements.
 
NOTE 3. BALANCE SHEET COMPONENTS
 
Inventory
 
The Company operates in an industry characterized by rapid improvements and changes to its technology and products. The introduction of new products by the Company or its competitors can result in its inventory being rendered obsolete or it being required to sell items at a discount. The Company evaluates the recoverability of its inventory by reference to its internal estimates of future demands and product life cycles. If the Company incorrectly forecasts demand for its products or inadequately manages the introduction of new product lines, the Company could materially impact its financial statements by having excess inventory on hand. The Company's future estimates are subjective and actual results may vary.
 
Inventories are recorded at cost using the First-In-First-Out (“FIFO”) method. Ending inventories are comprised of raw materials and direct costs of manufacturing and are valued at the lower of cost or market. Inventories consisted of the following as of October 31, 2012 and April 30, 2012:

   
October 31, 2012
   
April 30, 2012
 
Raw materials
  $ 28,779     $ 25,579  
Finished goods
    80,578       57,791  
    $ 109,357     $ 83,370  
 
Other current assets
 
Other current assets consist of the following as of October 31, 2012 and April 30, 2012:
 
   
October 31, 2012
   
April 30, 2012
 
R&D materials
  $ 88,110     $ 116,936  
Deferred cost of sales
    35,000       -  
Dermacyte samples
    14,994       19,529  
Other
    7,091       11,394  
Unbilled government grant expenses
    -       14,950  
    $ 145,195     $ 162,809  
 
Property and equipment, net
 
Property and equipment consist of the following as of October 31, 2012 and April 30, 2012:
 
   
October 31, 2012
   
April 30, 2012
 
Laboratory equipment
  $ 959,401     $ 968,101  
Computer equipment and software
    134,005       134,005  
Office furniture and fixtures
    130,192       140,255  
Leasehold improvements
    -       4,810  
      1,223,598       1,247,171  
Less: Accumulated depreciation and amortization
    (976,073 )     (953,565 )
    $ 247,525     $ 293,606  

Depreciation and amortization expense was approximately $23,000 and $47,000 for the three months ended October 31, 2012 and 2011, respectively; and $47,000 and $97,000 for the six months ended October 31, 2012 and 2011, respectively.
 
 
 
10

 
 
Other assets
 
Other assets consist of the following as of October 31, 2012 and April 30, 2012:
 
   
October 31, 2012
   
April 30, 2012
 
Prepaid royalty fee
  $ 50,000     $ 50,000  
Other
    8,262       15,666  
    $ 58,262     $ 65,666  

Accrued liabilities
 
Accrued liabilities consist of the following as of October 31, 2012 and April 30, 2012:
 
   
October 31, 2012
   
April 30, 2012
 
Deferred government grant revenue
  $ 229,474     $ 244,013  
Convertible note interest payable
    61,500       59,583  
Employee related
    54,815       352,400  
Restructuring liability
    43,728       -  
Other
    24,437       64,012  
Preferred stock dividend payable
    14,863       21,479  
Section 409A tax liability
    -       532,350  
    $ 428,817     $ 1,273,837  
 
Other liabilities
 
As further discussed in Note 10 below, following the closing of the Company’s research and development facility in California, the Company recorded a liability for the remaining lease payments due under its long-term, non-cancelable operating lease for this facility, which expires in July 2015. The table below summarizes the future minimum payments due under this lease agreement.
 
   
October 31, 2012
   
April 30, 2012
 
Non-cancelable operating lease obligation
  $ 120,252     $ -  
Less: current portion
    (43,728 )     -  
Long-term portion of non-cancelable operating lease obligation
  $ 76,524     $ -  
 
The Company has entered into a long-term sublease agreement with an unrelated third party covering the vacated space, which extends through the termination date.
 
 
 
11

 
 
NOTE 4. INTANGIBLE ASSETS
 
The following table summarizes the Company’s intangible assets as of October 31, 2012:
 
Asset Category
 
Value Assigned
   
Weighted Average Amortization Period (in Years)
   
Impairments
   
Accumulated Amortization
   
Carrying Value (Net of Impairments and Accumulated Amortization)
 
                               
Patents
  $ 587,007       11.5     $ -     $ (246,515 )   $ 340,492  
License Rights
    557,287       16.4       -       (103,438 )     453,849  
Trademarks
    110,157       N/A       -       -       110,157  
Total
  $ 1,254,451             $ -     $ (349,953 )   $ 904,498  
 
The following table summarizes the Company’s intangible assets as of April 30, 2012:
 
Asset Category
 
Value Assigned
   
Weighted Average Amortization Period (in Years)
   
Impairments
   
Accumulated Amortization
   
Carrying Value (Net of Impairments and Accumulated Amortization)
 
                               
Patents
  $ 546,624       11.7     $ -     $ (233,989 )   $ 312,635  
License Rights
    540,668       16.6       -       (89,429 )     451,239  
Trademarks
    138,631       N/A       (29,534 )     -       109,097  
Total
  $ 1,225,923             $ (29,534 )   $ (323,418 )   $ 872,971  
 
The aggregate amortization expense on the above intangibles was approximately $13,000 and $10,000, for the three months ended October 31, 2012 and 2011, respectively; and $27,000 and $21,000, for the six months ended October 31, 2012 and 2011 respectively.
 
Patents and License Rights
 
The Company currently holds, has filed for, or owns exclusive rights to, U.S. and worldwide patents covering 13 various methods and uses of its perfluorocarbon (“PFC”) technology. It capitalizes amounts paid to third parties for legal fees, application fees and other direct costs incurred in the filing and prosecution of its patent applications. These capitalized costs are amortized on a straight-line method over their useful life or legal life, whichever is shorter.
 
Trademarks
 
The Company currently holds, or has filed for, trademarks to protect the use of names and descriptions of its products and technology. It capitalizes amounts paid to third parties for legal fees, application fees and other direct costs incurred in the filing and prosecution of its trademark applications. These trademarks are evaluated annually in accordance with ASC 350, Intangibles – Goodwill and other. The Company evaluates (i) its expected use of the underlying asset, (ii) any laws, regulations, or contracts that may limit the useful life, (iii) the effects of obsolescence, demand, competition, and stability of the industry, and (iv) the level of costs to be incurred to commercialize the underlying asset.
 
 
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NOTE 5. SERIES A CONVERTIBLE PREFERRED STOCK
 
Under the Company’s Certificate of Incorporation, the Board of Directors is authorized, without further stockholder action, to provide for the issuance of up to 10,000,000 shares of preferred stock, par value $0.0001 per share, in one or more series, to establish from time to time the number of shares to be included in each such series, and to fix the designation, powers, preferences and rights of the shares of each such series and the qualifications, limitations and restrictions thereof.
 
On December 8, 2011, the Company filed a Certificate of Designation with the Secretary of State of the State of Delaware designating 7,500 shares of its authorized but unissued shares of preferred stock as Series A Convertible Preferred Stock.
 
 
Series A Convertible Preferred Stock
 
On December 12, 2011, the Company sold 3,500 units for net proceeds of approximately $3.2 million. Each unit sold consisted of (i) one share of the Company’s Preferred Stock and (ii) a warrant representing the right to purchase 225.2 shares of Common Stock (the “2011 Warrants”), at a price of $1,000 per unit, less issuance costs. The shares of Preferred Stock were immediately convertible and the 2011 Warrants are exercisable on the one-year anniversary of the closing date.
 
On June 15, 2012, the Company sold an additional 2,500 units for net proceeds of approximately $2.3 million. Each unit sold consisted of (i) one share of the Company’s Preferred Stock and (ii) a 2011 Warrant, at a price of $1,000 per unit, less issuance costs. The shares of Preferred Stock were immediately convertible and the 2011 Warrants are exercisable beginning on the one-year anniversary of the closing date.
 
The table below sets forth a summary of the designation, powers, preferences and rights of the Preferred Stock.
 
Maturity
The shares of Preferred Stock will mature on the one year anniversary of issuance of such shares.
 
Amortization
On each one month anniversary of issuance of the Preferred Stock, the Company will redeem, subject to certain exceptions (i) with respect to shares issued in the first closing, one-sixth of the initial stated value of the Preferred Stock, and (ii) with respect to shares issued in the additional closings, 667 shares of Preferred Stock.
 
Amortization Payments
The Company may elect to pay the monthly amortization payments in cash or, subject to certain conditions, in shares of Common Stock by delivering that number of shares of Common Stock equal to the amount of the monthly amortization payment divided by a per share amortization price, which shall be the lesser of (i) the then-existing conversion price, which is initially $2.22 per share of common stock and (ii) 90% of the calculated market price per share of Common Stock.
 
Dividends
The shares of Preferred Stock will carry a dividend equal to 7% per annum, paid monthly in arrears. The Company may elect to pay dividends in cash or, subject to certain conditions, in shares of Common Stock.  If the Company pays dividends in shares of Common Stock, the shares will be valued at a calculated per share market price. Dividends shall be subject to a make-whole through maturity upon any earlier conversion, redemption or amortization.
 
Market Price
For purposes of the amortization or dividend payments on the Preferred Stock as described above, the market price shall be equal to the average of the volume weighted average prices (the “VWAP”) for the five lowest trading days, excluding the two lowest trading days of such period, ending on the 23rd trading day prior to the applicable payment date, subject to a “true up” based on the five lowest trading days during the twenty consecutive trading days ending on the trading day immediately prior to the applicable payment date.
 
Conversion
Holders may elect to convert shares of Preferred Stock into shares of Common Stock at the then-existing conversion price at any time.  The initial conversion price is $2.22 per share of Common Stock, and is subject to certain adjustments, including an anti-dilution provision that reduces the conversion price upon the issuance of any Common Stock or securities convertible into Common Stock at an effective price per share less than the conversion price.
 
Redemption
If any shares of Preferred Stock remain outstanding on the maturity date after giving effect to any conversions on such date, the Company is required to redeem such preferred shares in cash in an amount equal to the then-existing conversion amount for each preferred share.
Additionally, after a triggering event, the holders of the shares of Preferred Stock have the right, at their option, to require the Company to redeem all or a portion of the then outstanding preferred shares in cash at the triggering event redemption price.
Triggering events include, among other events, certain breaches by the Company of its agreements, failures to pay amounts when due, failures to maintain any registration statement as required, failure to keep its Common Stock listed on any of the specified eligible markets (including the OTC Bulletin Board), and failure to keep a sufficient number of authorized shares reserved for issuance on conversion of the Preferred Stock or exercise of the 2011 Warrants.
The triggering event redemption price will be the greater of (i) 125% of the then-existing conversion amount, or (ii) the product of the then-existing conversion amount and the greatest closing sales price of the Company’s Common Stock beginning on the last trading day prior to the triggering event and ending on the date the holder of the Preferred Stock delivers a notice of redemption. In addition, the Company is required to pay to the holders of the Preferred Stock any additional make-whole amounts accrued at the date of the triggering event.
 
Liquidation preference
In the event of the Company’s voluntary or involuntary dissolution, liquidation or winding up, each holder of Preferred Stock will be entitled to be paid a liquidation preference equal to the initial stated value of such holder’s Preferred Stock of $2.22 per share, plus accrued and unpaid dividends and any other payments that may be due on such shares, before any distribution of assets may be made to holders of capital stock ranking junior to the Preferred Stock.
 
Voting rights
Shares of Preferred Stock will generally have no voting rights, except as required by law and except that the consent of holders of a majority of the outstanding. Preferred Stock will be required to amend the terms of the Preferred Stock.
 
Equity Conditions
The “Equity Conditions” will be satisfied on any date if: (i) on each day during the 30 trading days prior to such measurement date, all shares of Common Stock issued and issuable upon conversion of the Preferred Stock , as dividends on the Preferred Stock and upon exercise of the 2011 Warrants will have been issued or, to the extent not yet issued will be eligible for sale without restriction and without the need for registration under the securities laws; (ii) on each such day, the Common Stock is listed on The NASDAQ Capital Market, on one of several named alternative markets and, if subject to certain delisting proceedings or a failure to meet the maintenance standards of such an exchange, the Company must meet the minimum listing conditions of one of the other permitted markets (including the OTC Bulletin Board); (iii) on each such day, the Company has delivered Common Stock upon conversion by holders of Preferred Stock on a timely basis, as and if required; (iv) any applicable shares to be issued in connection with the determination may be issued in full without violating the ownership limitations described below or the rules of the Company’s principal market (except that the ownership limitations will not prevent the Company from delivering Common Stock in amounts up to such limits); (v) during such period, the Company has made timely payments as required; (vi) there has been no triggering event or potential triggering event under the certificate of designations; (vii) the Company has no knowledge of any fact that would cause the shares of Common Stock issuable in connection with the Preferred Stock or Preferred Warrants not to be eligible for sale without restriction; (viii) the Company meets certain minimum average trading volume qualifications on its principal market (i.e., a $375,000 aggregate dollar volume over the applicable 20 trading days); and (ix) the Company is otherwise in material compliance with its covenants and representations in the related Preferred Stock transaction documents, including the certificate of designations.
 
 
 
 
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The Company will not affect any conversion of the Preferred Stock, nor shall a holder convert its shares of Preferred Stock, to the extent that such conversion would cause the holder to have acquired, through conversion of the Preferred Stock or otherwise, beneficial ownership of a number shares of Common Stock in excess of 4.99% of the Common Stock outstanding immediately preceding the conversion.
 
While the Preferred Stock is outstanding, the Company may not incur any additional indebtedness, with the exception of ordinary course equipment leases, obligations to vendors and similar exceptions. The Company is also prohibited from issuing additional or other capital stock or from issuing variable rate securities, without the consent of holders of the Preferred Stock then outstanding.
 
The scheduled conversions and actual activity for the Preferred Stock as of October 31, 2012 is as follows:
 
Installment Date
 
Pre-delivery Date
 
Preferred Shares Redeemedable
   
Less: Preferred Shares Redeemed / Converted at 10/31/12
   
Balance of Preferred Shares at 10/31/12
   
Fair Value of Preferred Stock at 10/31/12
 
                             
5/12/2012
 
4/10/2012
    583       (583 )     -     $ -  
6/12/2012
 
5/10/2012
    583       (583 )     -       -  
7/12/2012
 
6/8/2012
    2       (2 )     -       -  
7/16/2012
 
6/15/2012
    667       (667 )     -       -  
8/15/2012
 
7/13/2012
    667       (667 )     -       -  
9/17/2012
 
8/14/2012
    667       (667 )     -       -  
10/15/2012
 
9/12/2012
    499       (112 )     387       429,978  
Convertible preferred stock
                    387     $ 429,978  
 
During the six months ended October 31 2012, 3,281 shares of Preferred Stock were converted into 3,132,017 shares of Common Stock. The Company recorded interest expense of $461,031 related to these conversions. The interest expense was calculated as the difference between the fair value of the shares of Preferred Stock converted and the fair value of the Common Stock on the date of the conversion.
 
As of October 31, 2012, the following is a summary of the non-cash interest related to the Preferred Stock:
 
Interest expense on conversion of preferred stock
 
 Amount
 
Dividends paid in common stock
  $ 77,959  
Dividends paid in common stock with redemptions
    122,164  
Fair value of warrants issued with preferred shares
    656,535  
Interest expense on conversion of preferred stock
    461,031  
Fair value adjustment to preferred stock
    203,652  
Accrued dividends payable
    14,863  
Non-cash interest expense as of October 31, 2012
  $ 1,536,204  
 
On October 13, 2012, the Company elected to make the scheduled November 15, 2012 installment payment in shares of Common Stock and on that date issued 210,772 shares of Common Stock. The Company expects to make subsequent scheduled payments in shares of Common Stock to the extent the Preferred Stock has not been voluntarily converted by the holders.
 
On November 15, 2012, the Company did not issue any additional shares of Common Stock upon the conversion of 112 shares of Preferred Stock. The Company expects to report interest expense of $55,709 related to these conversions in the third quarter of fiscal year 2013.
 
 
 
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NOTE 6. NOTES PAYABLE
 
The following table summarizes the Company’s outstanding notes payable as of October 31, 2012 and April 30, 2012:
 
   
October 31, 2012
   
April 30, 2012
 
Current portion of convertible notes payable
  $ 7,195     $ 7,195  
Current portion of notes payable
    -       55,763  
Current portion of notes payable, net
  $ 7,195     $ 62,958  
                 
Long-term portion of convertible notes payable
  $ 4,900,001     $ 4,900,001  
Less: Unamortized discount
    (2,722,225 )     (3,538,891 )
Long-term portion of notes payable, net
  $ 2,177,776     $ 1,361,110  

Convertible Note
 
On June 29, 2011, the Company issued a note (the “June Note”) with a principal amount of approximately $300,000 and Warrants to purchase 133,038 shares of Common Stock. On July 1, 2011, the Company issued a separate note (together with the June Note, the “Notes”) with a principal amount of $4,600,000 and warrants to purchase 2,039,911 shares of Common Stock. The aggregate gross proceeds to the Company from the offering were approximately $4.9 million, excluding any proceeds from the exercise of any warrants. The aggregate placement agent fees were $297,000 and legal fees associated with the offering were $88,839. These costs have been capitalized as debt issue costs and will be amortized as interest expense over the life of the Notes. The Company recorded amortization of debt issue costs of $32,154 and $64,308 for each of the three and six months ended October 31, 2012 and 2011, respectively.
 
Interest on the Notes accrues at a rate of 15% annually and will be paid in quarterly installments commencing on the third month anniversary of issuance. The Notes will mature 36 months from the date of issuance. The Notes may be converted into shares of Common Stock at a conversion price of $2.255 per share (subject to adjustment for stock splits, dividends and combinations, recapitalizations and the like) (the “Conversion Price”) at any time, in whole or in part, at any time at the option of the holders of the Notes. The Notes also will automatically convert into shares of Common Stock at the Conversion Price at the election of a majority-in-interest of the holders of notes issued under the purchase agreement or upon the acquisition or sale of all or substantially all of the assets of the Company. The Company may make each applicable interest payment or payment of principal in cash, shares of Common Stock at the Conversion Price, or any combination thereof. The Company may elect to prepay all or any portion of the Notes without prepayment penalties only with the approval of a majority-in-interest of the note holders under the purchase agreement at the time of the election.   The Notes contain various events of default such as failing to timely make any payment under the Note when due, which may result in all outstanding obligations under the Note becoming immediately due and payable.
 
The Company recorded interest expense of $628,321 and $628,569 for the three months ended October 31, 2012 and 2011, respectively; and $1,256,641 and $836,648 for the six months ended October 31, 2012 and 2011, respectively.
 
The total value allocated to the warrants was approximately $1,960,497 and was recorded as a debt discount against the proceeds of the notes.  In addition, the beneficial conversion features related to the notes were determined to be approximately $2,939,504.  As a result, the aggregate discount on the notes totaled $4,900,000, and is being amortized over term of the notes. The Company recorded an amortization of debt discount of approximately $408,000 and $816,000 for each of the three and six months ended October 31, 2012 and 2011, respectively.
 
NOTE 7. COMMITMENTS AND CONTINGENCIES
 
Agreement with Virginia Commonwealth University
 
In May 2008 the Company entered into a license agreement with Virginia Commonwealth University (“VCU”) whereby it obtained a worldwide, exclusive license to valid claims under three of the VCU's patent applications that relate to methods for non-pulmonary delivery of oxygen to tissue and the products based on those valid claims used or useful for therapeutic and diagnostic applications in humans and animals. The license includes the right to sub-license to third parties. The term of the agreement is the life of the patents covered by the patent applications unless the Company elects to terminate the agreement prior to patent expiration.  Under the agreement the Company has an obligation to diligently pursue product development and pursue, at its own expense, prosecution of the patent applications covered by the agreement. As part of the agreement, the Company is required to pay to VCU nonrefundable payments upon achieving development and regulatory milestones. As of October 31, 2012, the Company has not met any of the developmental milestones.
 
The agreement with VCU also requires the Company to pay royalties to VCU at specified rates based on annual net sales derived from the licensed technology. Pursuant to the agreement, the Company must make minimum annual royalty payments to VCU totaling $70,000 as long as the agreement is in force. These payments are fully creditable against royalty payments due for sales and sublicense revenue earned during the fiscal year as described above. This fee is recorded as an other current asset and is amortized over the fiscal year. Amortization expense was $17,500 and $35,000 for each of the three and six months ended October 31, 2012 and 2011, respectively.
 
 
 
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Litigation
 
The Company is subject to litigation in the normal course of business, none of which management believes will have a material adverse effect on the Company’s financial statements.
 
On August 30, 2011, Tenor Opportunity Master Fund Ltd., Aria Opportunity Fund, Ltd., and Parsoon Opportunity Fund, Ltd (collectively, “Tenor”) filed a lawsuit in the United States District Court for the Southern District of New York alleging that a right of first offer held by Tenor was breached in connection with our June 2011 financing. The complaint seeks compensatory damages, attorneys’ fees and costs.  Discovery was completed and motions for summary judgment from both sides were filed, Plaintiffs filed on the matter of breach and we filed on the matter of damages.  On July 11, 2012 the court entered an order on both summary judgment motions.  The court found in favor of Plaintiff’s motion, holding that we did breach the agreement.  The court did not find in favor of our motion regarding damages.  The matter will now move to trial for a jury to determine what, if any, damages Plaintiff’s suffered from our breach of the agreement. The trial was scheduled to begin on October, 10, 2012. However, on October 3, 2012 the court granted a motion from Tenor to continue the trial and it is now currently scheduled to start on March 7, 2013.
 
The Company believes the facts do not support a finding in Tenor’s favor and, accordingly, has not accrued for any amounts for a contingent liability related to this claim as of October 31, 2012.
 
Registration Requirement
 
During the fiscal year ended April 30, 2008, the Company issued warrants as part of a convertible note offering.  These warrants were issued with a requirement that the Company file a registration statement with the Securities and Exchange Commission (“SEC”) to register the underlying shares, and that it be declared effective on or before January 9, 2009. In the event that the Company does not have an effective registration statement as of that date, or if at some future date the registration ceases to be effective, then the Company is obligated to pay liquidated damages to each holder in the amount of 1% of the aggregate market value of the stock, as measured on January 9, 2009 or at the date the registration statement ceases to be effective. As an additional remedy for non-registration of the shares, the holders would also receive the option of a cashless exercise of their warrant or conversion shares. As of October 31, 2012, approximately 126,000 of these warrants are subject to the registration requirement.
 
ASC 825-20, Financial Instruments, Registration Payment Arrangements, provides guidance to proper recognition, measurement, and classification of certain freestanding financial instruments that are indexed to, and potentially settled in, any entity's own stock. ASC 825-20-25 specifies that the contingent obligation to make future payments or otherwise transfer consideration under a registration payment arrangement, whether issued as a separate agreement or included as a provision of a financial instrument or other agreement, should be separately recognized and measured in accordance with ASC 450, Accounting for Contingencies. The Company has accounted for these warrants as equity instruments in the accompanying financial statements. The Company does not believe the registration payments are probable, and as such, has not recorded any amounts with respect to the separately measured registration rights agreement.
 
Contingent Liabilities Related to Internal Revenue Code Section 409A
 
In November, 2010, management conducted an independent review of certain option grants made by the Company between February 1998 and April 2009. This voluntary review was not in response to any governmental investigation. During the course of the Company’s review, management identified certain options granted in prior years that may have been non-compliant with Section 409A (“Section 409A”) of the Internal Revenue Code of 1986, as amended, including options granted with an exercise price below fair market value on the date of grant and options that were modified such that they may have become non-compliant with Section 409A.
 
In February 2011, after management conducted a preliminary, limited scope review of certain of the Company’s stock option granting practices, the Audit Committee commenced a voluntary, independent investigation of the Company’s historical stock option granting practices and related accounting during the period from February 1998 through April 2009. The Company’s outside legal counsel assisted the Audit Committee in this investigation.
 
The primary adverse tax consequence of Section 409A non-compliance is that the holders of non-compliant options are taxed on the value of such options as they vest, and annually thereafter until they are exercised. In addition to ordinary income taxes, holders of non-compliant options are subject to a 20% penalty tax under Section 409A (and, as applicable, similar excise taxes under state laws). Because virtually all holders of stock options granted by the Company were not involved in or aware that the pricing and/or modification of their options raised these issues, the Company intends to take actions to address certain of the adverse tax consequences that may apply to these holders. In addition, on March 17, 2011 the Company entered into indemnification agreements with its executive officers that indemnify those officers from potential Section 409A tax liabilities arising from their prior option awards.
 
As of October 31, 2012, all of the potentially non-compliant options were either cancelled or expired unexercised. The Company evaluated the contingent liability and concluded that the likelihood of an asserted claim is no longer probable and fails to satisfy the accrual criteria in accordance with ASC 450. As of October 31, 2012, the Company recorded a credit of approximately $532,500 against general and administrative expense in the statement of operations and reduced its accrual for the potential liability to $0.
 
 
 
16

 
 
NOTE 8. STOCKHOLDERS’ EQUITY
 
Common Stock
 
The Company’s Certificate of Incorporation authorizes it to issue 400,000,000 shares of $0.0001 par value common stock. As of October 31, 2012, there were 32,899,900 shares of common stock issued and outstanding.
 
Warrants
 
As further discussed in Note 5 above, on June 15, 2012, the Company issued 563,064 warrants as part of the second closing of the Series A Convertible Preferred Stock. The warrants were issued with an exercise price of $2.22 and a six-year term. The warrants become exercisable on the one-year anniversary of the issue date. The Company recorded non-cash interest expense of $656,535 during the six months ended October 31, 2012 for the calculated fair value of the warrants.
 
The following table summarizes the Company’s warrant activity for the six months ended October 31, 2012:
 
   
Warrants
   
Weighted Average Exercise Price
 
Outstanding at April 30, 2012
    5,239,964     $ 2.08  
Issued
    563,064       2.22  
Forfeited
    (101,153 )     3.68  
Outstanding at October 31, 2012
    5,701,875     $ 2.07  
 
1999 Amended Stock Plan
 
In October 2000, the Company adopted the 1999 Stock Plan, as amended and restated on June 17, 2008 (the “Plan”). Under the Plan, with the approval of the Compensation Committee of the Board of Directors, the Company may grant stock options, restricted stock, stock appreciation rights and new shares of Common Stock upon exercise of stock options. On September 30, 2011, the Company’s stockholders approved an amendment to the Plan which increased the amount of shares authorized for issuance under the Plan to 6,000,000, up from 800,000 previously authorized. As of October 31, 2012 the Company had 5,514,337 shares of Common Stock available for grant under the Plan.
 
The following table summarizes the shares available for grant under the Plan for the six months ended October 31, 2012:
 
   
Shares Available for Grant
 
Balances, at April 30, 2012
    5,531,630  
Options granted
    (29,891 )
Options cancelled/forfeited
    103,167  
Restricted stock granted
    (102,759 )
Restricted stock cancelled/forfeited
    12,190  
Balances, at October 31, 2012
    5,514,337  
 
Plan Stock Options
 
Stock options granted under the Plan may be either incentive stock options (“ISOs”), or nonqualified stock options (“NSOs”). ISOs may be granted only to employees. NSOs may be granted to employees, consultants and directors. Stock options under the Plan may be granted with a term of up to ten years and at prices no less than fair market value for ISOs and no less than 85% of the fair market value for NSOs. Stock options granted generally vest over one to three years.
 
The following table summarizes the outstanding stock options under the Plan for the six months ended October 31, 2012:
 
   
Outstanding Options
 
   
Number of Shares
   
Weighted Average Exercise Price
 
Balances, at April 30, 2012
    351,823     $ 4.06  
Options granted
    29,891     $ 1.70  
Options cancelled
    (104,667 )   $ 5.66  
Balances, at October 31, 2012
    277,047     $ 3.20  
 
 
17

 
 
The Company chose the “straight-line” attribution method for allocating compensation costs of each stock option over the requisite service period using the Black-Scholes Option Pricing Model to calculate the grant date fair value.
 
The Company used the following assumptions to estimate the fair value of options granted under its stock option plans for the six months ended October 31, 2012 and 2011, respectively:
 
   
For the the six months ended October 31
 
   
2012
   
2011
 
Risk-free interest rate (weighted average)
    1.29 %     2.38 %
Expected volatility (weighted average)
    79.17 %     78.47 %
Expected term (in years)
    7       7  
Expected dividend yield
    0.00 %     0.00 %
 
Risk-Free Interest Rate
The risk-free interest rate assumption was based on U.S. Treasury instruments with a term that is consistent with the expected term of the Company’s stock options.
Expected Volatility
The expected stock price volatility for the Company’s common stock was determined by examining the historical volatility and trading history for its common stock over a term consistent with the expected term of its options.
Expected Term
The expected term of stock options represents the weighted average period the stock options are expected to remain outstanding. It was calculated based on the historical experience that the Company has had with its stock option grants.
Expected Dividend Yield
The expected dividend yield of 0% is based on the Company’s history and expectation of dividend payouts. The Company has not paid and does not anticipate paying any dividends in the near future.
Forfeitures
Stock compensation expense recognized in the statements of operations for the three and six months ended October 31, 2012 and 2011 is based on awards ultimately expected to vest, and it has been reduced for estimated forfeitures. ASC 718 requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Forfeitures were estimated based on the Company’s historical experience.
 
As of October 31, 2012, there were unrecognized compensation costs of approximately $48,800 related to non-vested stock option grants that will be recognized on a straight-line basis over the weighted average remaining vesting period of 1.6 years.
 
Restricted Stock Grants
 
The following table summarizes the restricted stock grants under the Plan for the six months ended October 31, 2012.
 
   
Outstanding Restricted Stock Grants
 
   
Number of Shares
   
Weighted Average Grant Date Fair Value
 
Balances, at April 30, 2012
    36,095     $ 2.19  
Restricted stock granted
    102,759     $ 1.78  
Restricted stock vested
    (50,992 )   $ 1.98  
Restricted stock cancelled
    (12,190 )   $ 1.85  
Balances, at October 31, 2012
    75,672     $ 1.83  
 
The Company recorded compensation expense for these restricted stock grants of $44,158 and $122,228 for the three and six months ended October 31, 2012, respectively.
 
As of October 31, 2012, there were unrecognized compensation costs of approximately $46,610 related to the non-vested restricted stock grants that will be recognized on a straight-line basis over the remaining vesting period.
 
NOTE 9. SEGMENT REPORTING
 
In the Company’s operation of its business, management, including its chief operating decision maker, the Chief Executive Officer, reviews certain financial information, including segmented internal profit and loss statements prepared on a basis not consistent with GAAP.
 
The Company operates in a single market consisting of the design, development, marketing, sales and support of its Dermacyte® cosmetic segment. The Company’s commercial revenues are derived from sales of the Dermacyte line of topical cosmetic products in the United States and Latin America. The Company does not engage in intercompany revenue transfers between segments.
 
The Company’s management evaluates performance based primarily on revenues in the geographic locations in which the Company operates. Segment profit or loss for each segment includes certain sales and marketing expenses directly attributable to the segment and excludes certain expenses that are managed outside the reportable segments.
 
Costs that are identifiable are allocated to the segments that benefit.  Allocated costs may include those relating to development and marketing of products and services from which multiple segments benefit, or those costs relating to services performed by one segment on behalf of other segments. Each allocation is measured differently based on the specific facts and circumstances of the costs being allocated. Certain other corporate-level activity is not allocated to the Company’s segments, including costs of: human resources; legal; finance; information technology; corporate development and procurement activities; research and development; and employee severance.
 
 
 
18

 
 
The Company has recast certain prior period amounts within this note to conform to the way it internally managed and monitored segment performance during the current fiscal year.
 
Net revenues and segment profit, classified by the Company’s reportable segments are as follows:
 
   
For the three months ending October 31,
   
For the six months ending October 31,
 
   
2012
   
2011
   
2012
   
2011
 
Product revenue
                       
United States
  $ 14,571     $ 27,415     $ 26,028     $ 60,892  
Latin America
    -       -       -       26,000  
Total product revenue
  $ 14,571     $ 27,415     $ 26,028     $ 86,892  
                                 
                                 
   
For the three months ending October 31,
   
For the six months ending October 31,
 
     2012      2011      2012      2011  
Segment loss (income)
                               
United States
  $ 47,856     $ 117,120     $ 80,914     $ 332,165  
Latin America
    -       -       -       (10,585 )
Unallocated revenues
                               
  Government grant revenue
    (509,435 )     (78,244 )     (775,984 )     (78,244 )
Unallocated expenses
                               
  General and administrative
    369,550       1,526,775       1,593,734       3,098,431  
  Research and development
    604,574       488,577       1,241,846       1,140,538  
  Restructuring expense
    170,298       -       217,774       -  
  Net interest and other expense
    874,435       875,695       2,785,535       1,316,687  
Net loss
  $ 1,557,278     $ 2,929,923     $ 5,143,819     $ 5,798,992  
 
Assets are not allocated to segments for internal reporting presentations. A portion of amortization and depreciation may be included with various other costs in an overhead allocation to each segment and it is impracticable for the Company to separately identify the amount of amortization and depreciation by segment that is included in the measure of segment profit or loss.
 
NOTE 10. RESTRUCTURING EXPENSE
 
In May 2012, the Company decided to consolidate its operations and relocate its research and development function to North Carolina from Costa Mesa, California. To allow for this transition period, all existing development work had been completed and all of the manufacturing of the Company’s PFC-based products had been transferred to contract manufacturers. As part of these initiatives, the Company terminated all related research and development activities and a workforce reduction was implemented.  In September 2012, the Company entered into a sublease agreement with an unrelated third party that extends throughout the remaining term of the existing lease for the vacated facility.
 
The Company incurred a restructuring expense of $217,774 related to the closing during the six months ended October 31, 2012. The Company expects to incur additional costs as a result of the restructuring, but it does not expect these costs to be significant beyond October 31, 2012. The following table summarizes the impact of the work force reductions and other associated costs on operating expenses and payments for the six months ended October 31, 2012, and the liability remaining on the balance sheet as of October 31, 2012.
 
   
Charges Incurred During the Six Months Ended October 31, 2012
   
Amounts Paid Through October 31, 2012
   
Amounts Accrued at October 31, 2012
 
Future lease obligations, net of sublease revenue
  $ 134,984     $ 21,632     $ 120,252  
Employee severance, benefits and related costs for work force reductions
    53,991       53,991       -  
Other exit costs
    28,799       28,799       -  
                         
 
The Company recorded all restructuring expenses as operating expenses on the statement of operations. All restructuring costs are expected to be paid by January 31, 2013, with the exception of approximately $109,000 of future lease obligations, net of sublease revenue.
 
During the six months ended October 31, 2012, the Company recognized an impairment loss of approximately $12,000 related to the disposal lab equipment as a result of the decision to discontinue internal manufacturing and development activities which is not recorded in the table above.
 
 
19

 
 
ITEM 2.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
 
 
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, which are subject to the “safe harbor” created by those sections. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to them. In some cases you can identify forward-looking statements by words such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “potential” and similar expressions intended to identify forward-looking statements. Examples of these statements include, but are not limited to, statements regarding: the implications of interim or final results of our clinical trials, the progress of our research programs, including clinical testing, the extent to which our issued and pending patents may protect our products and technology, our ability to identify new product candidates, the potential of such product candidates to lead to the development of commercial products, our anticipated timing for initiation or completion of our clinical trials for any of our product candidates, our future operating expenses, our future losses, our future expenditures for research and development, and the sufficiency of our cash resources. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including the risks faced by us and described in Part II, Item 1A of this Quarterly Report on Form 10-Q, Part I, Item IA of our Annual Report on Form 10-K and our other filings with the Securities and Exchange Commission, or SEC. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this Quarterly Report on Form 10-Q. You should read this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results may be materially different from those we expect. Except as required by law, we assume no obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise.
 
The following discussion and analysis should be read in conjunction with the unaudited financial statements and notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q and with the audited financial statements and related notes thereto included as part of our Annual Report on Form 10-K for the year ended April 30, 2012.
 
All references in this Quarterly Report to “Oxygen Biotherapeutics”, “we”, “our” and “us” means Oxygen Biotherapeutics, Inc.

Overview
 
Strategy
 
We are a development stage biomedical company focused on developing oxygen-carrying intravenous and topical products. Our principal business objective is to discover, develop, and commercialize novel therapeutic products for disease indications that represent significant areas of clinical need and commercial opportunity.
 
Our current strategy is to:
 
  
Efficiently conduct clinical development to establish clinical proof of concept with our lead product candidates;
 
  
Advance the development of the perfluorocarbon, or PFC, therapeutic modality and supporting capabilities;
 
  
Efficiently explore new high-potential therapeutic applications, leveraging third-party research collaborations and our results from related areas;
 
  
Continue to expand our intellectual property portfolio; and
 
  
Enter into licensing or product co-development arrangements in certain areas, while out-licensing opportunities in non-core areas.
 
We believe that this strategy will allow us to develop a portfolio of high quality product development opportunities, expand our clinical development and commercialization capabilities, and enhance our ability to generate value from our proprietary technologies.
 
 
 
20

 
 
Second Quarter 2013 Highlights
 
The following summarizes certain key financial measures for the three months ended October 31, 2012:
 
  
Cash and cash equivalents were $1.5 million at October 31, 2012.
 
  
Net product sales from Dermacyte® were $14,600 for the second quarter of 2013 compared to $27,400 for the three months ended October 31, 2011.
 
  
Revenue earned under our research grant was $509,000 for the second quarter of 2013 compared to $78,000 for the three months ended October 31, 2011.
 
  
Our loss from operations was $0.7 million for the second quarter of 2013 compared to $2.1 million for the three months ended October 31, 2011.
 
  
Net cash used in operating activities was $1.1 million for the second quarter of 2013 compared to $2.5 million for the three months ended October 31, 2011.
 
Consistent with our strategy, during the three months ended October 31, 2012, we (i) completed the preclinical pharmacokinetics studies of Oxycyte, (ii) completed the in vitro platelet function studies in healthy volunteers and began the repeat studies using TBI subjects, (iii) began the in-life portion of the preclinical studies to evaluate the impact of Oxycyte on the immune system and (iv) engaged a CRO to manage our Phase II-B TBI clinical trials, which are expected to resume enrollment during the next fiscal quarter.
 
Opportunities and Trends
 
We continue to execute on our strategic plan, which calls for resuming our STOP-TBI (Safety and Tolerability of Oxycyte in Patients with Severe non-Penetrating Traumatic Brain Injury) Phase II-B clinical trials; supporting our collaborations to gather proof-of-concept data for additional therapeutic areas with unmet medical needs; and continuing our business development efforts to expand our product portfolio. We also continue to progress Oxycyte® through the regulatory approval process by conducting a comprehensive group of preclinical studies to confirm the safety profile of our product.  These studies are particularly focused on platelet activity and immunocompetence. We believe these actions position us well to drive future growth and create stockholder value.
 
As we focus on the development of our existing products and product candidates, we also continue to position ourselves to execute upon licensing and other partnering opportunities. In order to do so, we will need to continue to maintain our strategic direction, manage and deploy our available cash efficiently and strengthen our collaborative research development and partner relationships.
 
During fiscal year 2013 we are focused on the following four key initiatives:
 
  
Conducting well-designed studies early in the clinical development process to establish a robust foundation for subsequent development, partnership and expansion into complementary areas;
 
  
Working with collaborators and partners to accelerate product development, reduce our development costs, and broaden our commercialization capabilities;
 
  
Gaining regulatory approval for the continued development and commercialization of Oxycyte in the United States; and
 
  
Developing new intellectual property will enable us to file patent applications that cover new applications of our existing technologies and product candidates.
 

 
21

 
 
Critical Accounting Policies and Significant Judgments and Estimates
 
Critical accounting policies and estimates are those policies and estimates that are most important and material to the preparation of our financial statements, and which require management’s most subjective and complex judgment due to the need to select policies from among alternatives available, and to make estimates about matters that are inherently uncertain.
 
As further discussed in Note 7, Commitments and Contingencies, of our Notes to Financial Statements of this quarterly report on Form 10-Q, during the three months ended October 31, 2012, management recorded a significant change to its estimate of the accrued liability relating to Section 409A of the Internal Revenue Code of 1986, as amended, or 409A, as compared to the critical accounting policies and estimates described in “Part II, Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates” in our Annual Report on Form 10-K for the fiscal year ended April 30, 2012.
 
Financial Overview
 
Results of Operations- Comparison of the Three Months Ended October 31, 2012 and 2011
 
Revenue
 
Product Revenue and Gross Profit
 
We generate revenue through the sale of Dermacyte® through on-line retailers and physician and medical spa facilities. Product revenue and percentage changes for the three months ended October 31, 2012 and 2011, respectively, are as follows:
 
   
Three months ended October 31,
   
Increase/
(Decrease)
   
% Increase/
(Decrease
)
 
   
2012
   
2011
             
Product revenue
  $ 14,571     $ 27,415     $ (12,844 )     (47) %
Cost of sales     9,134       10,500       (1,366 )     (13) %
Gross Profit   $ 5,437     $ 16,915     $ (11,478 )     (68) %
 
The decrease in product revenue for the three months ended October 31, 2012 was primarily due to the reduction in our internal sales force and the termination of existing distribution agreements in the prior year. During the current period, we employed only one internal salesperson compared to three during the same period in the prior year.
 
Gross profit as a percentage of revenue was 37% and 62% for three months ended October 31, 2012 and 2011, respectively. The decrease for the three months ended October 31, 2012 was due to an increase in the unit cost of our product mix as compared to the same period in the prior year.
 
Government Grant Revenue
 
We earn revenues through a cost-reimbursement grant sponsored by the United States Army, or Grant Revenue. Grant Revenue is recognized as milestones under the Grant program are achieved. Grant Revenue is earned through reimbursements for the direct costs of labor, travel, and supplies, as well as the pass-through costs of subcontracts with third-party contract research organizations, or CROs.
 
   
Three months ended October 31,
   
Increase/
(Decrease)
   
% Increase/
(Decrease
)
 
   
2012
   
2011
             
Government grant revenue   $ 509,435     $ 78,244     $ 431,191       551 %
 
For the three months ended October 31, 2012, we recorded an increase of approximately $431,000 in revenue under the grant program as compared to the same period in the prior year. This increase is due to the progress of the underlying studies and the achievement of contractual milestones under the grant.
 
 
 
22

 
 
Marketing and Sales Expenses
 
Marketing and sales expenses consisted primarily of personnel-related costs, including salaries, commissions, and the costs of marketing programs aimed at increasing revenue, such as advertising, trade shows, public relations and other market development programs. Marketing and sales expenses and percentage changes for the three months ended October 31, 2012 and 2011, respectively, are as follows:
 
   
Three months ended October 31,
   
Increase/
(Decrease)
   
% Increase/
(Decrease
)
 
   
2012
   
2011
             
Marketing and sales expense
  $ 53,293     $ 134,035     $ (80,742 )     (60 ) %
 
The decrease in marketing and sales expenses for the three months ended October 31, 2012 was driven primarily by a decrease in the costs incurred for compensation and direct advertising.
 
-  
We reduced compensation costs related to marketing and selling the cosmetic topical product line Dermacyte by approximately $50,000 compared to the same period in the prior year. These costs include salaries, commissions, and employee benefits.
 
-  
Costs related to direct marketing and advertising decreased by approximately $24,000 compared to the same period in the prior year. These costs include attendance at trade shows and conferences, fees paid to a third party public relations firm, the costs of product samples distributed to potential customers, and the costs of direct print and online advertisements.
 
-  
We reduced our travel and marketing sample expenses by approximately $7,000 during the three months ended October 31, 2012 as compared to the same period in the prior year.  This decrease was a result of our regional market focus and our reduction in overall headcount.
 
General and Administrative Expenses
 
General and administrative expenses consist primarily of compensation for executive, finance, legal and administrative personnel, including stock-based compensation. Other general and administrative expenses include facility costs not otherwise included in research and development expenses, legal and accounting services, other professional services, and consulting fees. General and administrative expenses and percentage changes for the three months ended October 31, 2012 and 2011, respectively, are as follows:
 
   
Three months ended October 31,
   
Increase/
(Decrease)
   
% Increase/
(Decrease)
 
   
2012
   
2011
             
Personnel costs
  $ 384,997     $ 416,132     $ (31,135 )     (7 ) %
Legal and professional fees
    361,079       919,730       (558,651 )     (61 ) %
Facilities
    43,800       72,907       (29,107 )     (40 ) %
Depreciation and amortization
    27,162       17,792       9,370       53 %
Other costs
    (447,488 )     100,214       (547,702 )     (547 ) %
 
Personnel costs:
 
Personnel costs decreased approximately $31,000 for the three months ended October 31, 2012 compared to the same period in the prior year. The decrease was due primarily to our termination of our Chief Executive Officer in the prior year.
 
 
 
23

 
 
Legal and professional fees:
 
Legal and professional fees decreased approximately $560,000 for the three months ended October 31, 2012 compared to the same period in the prior year. This decrease was primarily due to decreases of approximately $320,000 in legal fees, $200,000 in board of director severance costs, and $40,000 in consulting fees.
 
In the prior period we recorded approximately $200,000 in severance costs associated with our previous President’s resignation from our Board of Directors. The decrease in legal fees was due primarily to the costs incurred during the prior period for the Audit Committee investigation, 409A review, and the 2011 Convertible Note transaction. The decrease in consulting fees is primarily due to associated with recruiting additional directors in the prior year.
 
Facilities:
 
Facilities include costs paid for rent and utilities at our corporate headquarters in North Carolina, the allocation of lease costs not otherwise included in Research and Development expenses, and the costs incurred for third party Information Technology (“IT”) support services. The $29,000 reduction in facilities costs during the three months ended October 31, 2012 as compared to the same period in the prior year was the result of the closure of our California facility.
 
Depreciation and Amortization:
 
The $9,000 increase in depreciation and amortization costs for the three months ended October 31, 2012 compared to the same period in the prior year was primarily due to an increase in capitalized patent expenses in the current period.
 
Other costs:
 
Other costs include costs incurred for travel, supplies, insurance and other miscellaneous charges. The $548,000 reduction in other costs was due primarily to a $532,000 reduction in our estimate of the accrued liability related to potential 409A violations and an overall decrease in administrative and office expenses as a result of headcount reductions as compared to the same period in the prior year.
 
Research and Development Expenses
 
Research and development expenses include, but are not limited to, (i) expenses incurred under agreements with CROs and investigative sites, which conduct our clinical trials and a substantial portion of our pre-clinical studies; (ii) the cost of manufacturing and supplying clinical trial materials; (iii) payments to contract service organizations, as well as consultants; (iv) employee-related expenses, which include salaries and benefits; and (v) facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities and equipment, depreciation of leasehold improvements, equipment, laboratory and other supplies. All research and development expenses are expensed as incurred. Research and development expenses and percentage changes for the three months ended October 31, 2012 and 2011, respectively, are as follows:
 
   
Three months ended October 31,
   
Increase/
(Decrease)
   
% Increase/
(Decrease
)
 
   
2012
   
2011
             
Clinical and preclinical development
  $ 374,683     $ 105,355     $ 269,328       256 %
Personnel costs
    162,419       221,064       (58,645 )     (27 ) %
Consulting
    49,470       93,460       (43,990 )     (47 ) %
Depreciation
    10,988       10,925       63       1 %
Other costs
    4,388       20,834       (16,446 )     (79 ) %
Facilities
    2,626       36,939       (34,313 )     (93 ) %
 
Clinical and preclinical development:
 
The increase of approximately $269,000 in clinical and preclinical development costs for the three months ended October 31, 2012 compared to the prior year was primarily due to increases in costs associated with our pre-clinical safety studies and current Good Manufacturing Practices, or cGMP, development for Oxycyte, costs incurred to resume our Phase II-b clinical trials, and development costs for Dermacyte.
 
-  
We incurred an increase of approximately $125,000 in pre-clinical study costs. These costs are the result of CRO fees for the completion for milestones under the Grant-funded preclinical program to assess the safety of Oxycyte for the treatment of patients with traumatic brain injury, or TBI.
 
-  
We incurred an increase of approximately $15,000 in Dermacyte development costs. These costs are the result of consulting fees for developing dermatologic indications, costs incurred for the proof of concept clinical trials and on-going product stability and development costs.
 
-  
We incurred an increase of approximately $50,000 in Oxycyte development costs. These costs are the result of developing cGMP supply and manufacturing capabilities and validated release methods for our clinical drug product.
 
-  
We incurred an increase of approximately $80,000 in costs for our Phase II-b clinical trials. These costs are the result of manufacturing clinical drug product for use in the second cohort and other costs incurred to resume our TBI trials.
 
 
24

 
Personnel costs:
 
Personnel costs decreased approximately $59,000 for the three months ended October 31, 2012 compared to the same period in the prior year, primarily due to headcount reductions in the California lab facility and the resignation of our Chief Medical Officer in the prior year.
 
Consulting fees:
 
Consulting fees decreased approximately $44,000 for the three months ended October 31, 2012 compared to the same period in the prior year, primarily due to charges under the consulting and separation agreement for our former President and Chief Operating Officer that were not incurred in the current period.
 
Depreciation:
 
Depreciation expense remained relatively consistent for the three months ended October 31, 2012 and 2011.
 
Other costs:
 
Other costs decreased approximately $16,000 for the three months ended October 31, 2012 as compared to the same period in the prior year, due primarily to a decrease of $6,000 in travel and $9,000 in supplies as a result of closing our California facility.
 
Facilities:
 
Facilities expense decreased approximately $34,000 for the three months ended October 31, 2012 as compared to the same period in the prior year, primarily as a result of closing our California facility.
 
Conducting a significant amount of research and development is central to our business model. Product candidates in later-stage clinical development generally have higher development costs than those in earlier stages of development, primarily due to the significantly increased size and duration of clinical trials. We plan to incur substantial research and development expenses for the foreseeable future in order to complete development of our most advanced product candidate, Oxycyte, and to conduct earlier-stage research and development on our topical applications.
 
The process of conducting preclinical studies and clinical trials necessary to obtain approval from the U.S. Food and Drug Administration, or the FDA, is costly and time consuming. The probability of success for each product candidate and clinical trial may be affected by a variety of factors, including, among other things, the quality of the product candidate’s early clinical data, investment in the program, competition, manufacturing capabilities and commercial viability. As a result of the uncertainties discussed above, uncertainty associated with clinical trial enrollment and risks inherent in the development process, we are unable to determine the duration and completion costs of current or future clinical stages of our product candidates or when, or to what extent, we will generate revenues from the commercialization and sale of any of our product candidates. Development timelines, probability of success and development costs vary widely. We are currently focused on developing our most advanced product candidate, Oxycyte, and our topical dermatologic indications; however, we will need substantial additional capital in the future in order to complete the development and potential commercialization of Oxycyte and other product candidates.
 
Restructuring expense
 
   
Three months ended October 31,
   
Increase/ (Decrease)
   
% Increase/ (Decrease)
 
   
2012
   
2011
             
Restructuring expense
  $ 170,298     $ -     $ 170,298       %
 
During the three months ended October 31, 2012, the Company recorded one-time charges of approximately $7,000 for severance and benefits related charges, $135,000 for net future lease obligations and $29,000 for other exit costs.
 
Interest expense
 
Interest expense includes the interest payments due under our long-term debt, amortization of debt issuance costs and accretion of discounts recorded against our outstanding notes. Interest expense also includes dividends and fair-value adjustments to the carrying value on our Series A Convertible Preferred Stock. Interest expense and percentage changes for the three months ended October 31, 2012 and 2011, respectively, are as follows:
 
   
Three months ended October 31,
   
Increase/
(Decrease)
   
% Increase/
(Decrease)
 
   
2012
   
2011
             
Interest expense
  $ 867,524     $ 871,768     $ (4,244 )     (0 ) %
 
 
 
25

 
 
Long-term notes payable:
 
Interest expense for our long-term notes payable was $0 and approximately $243,000 for the three months ended October 31, 2012 and 2011, respectively. These notes payable were repaid in full in November 2011.
 
Convertible notes payable:
 
Interest expense on our outstanding convertible notes was approximately $628,000 and $629,000 for the three months ended October 31, 2012 and 2011, respectively. The recorded interest for the three months ended October 31, 2012 was comprised of approximately $188,000 for quarterly interest payable, $408,000 for amortization of debt discounts and $32,000 for amortization of debt issue costs.
 
Series A Convertible Preferred Stock:
 
Interest expense on our outstanding Series A Convertible Preferred Stock was approximately $239,000 and $0 for the three months ended October 31, 2012 and 2011, respectively. The recorded interest for the three months ended October 31, 2012 includes approximately $195,000 for the excess of the fair-value of the shares issued upon conversion over the fair value of the Series A Convertible Preferred Stock. There were no shares of Series A Convertible Preferred Stock outstanding during the three months ended October 31, 2011.
 
Preferred Stock Dividends:
 
Interest expense recorded for the payment of dividends on the Preferred Stock was approximately $44,000 for the three months ended October 31, 2012. There were no shares of Series A Convertible Preferred Stock outstanding during the three months ended October 31, 2011.
 
Other income and expense
 
Other income and expense includes non-operating income and expense items not otherwise recorded in our statement of operations. These items include, but are not limited to, revenue earned under sublease agreements for our California facility, recognized gains and losses on foreign currency translations, interest income earned and fixed asset disposals. Other expense for the three months ended October 31, 2012 and 2011, respectively, is as follows:
 
   
Three months ended October 31,
   
Increase/ (Decrease)
 
   
2012
   
2011
       
Other expense, net
  $ 6,911     $ 3,927     $ 2,984  
 
During the three months ended October 31, 2012 compared to the prior year, we recorded income from sublease agreements and interest of approximately $5,000 and $3,000, respectively. We recorded losses of approximately $12,000 and $7,000 from the disposal of fixed assets and other non-operating expenses.
 
 
26

 
 
Results of Operations- Comparison of the Six Months Ended October 31, 2012 and 2011
 
Revenue
 
Product Revenue and Gross Profit
 
We generate revenue through the sale of Dermacyte® through on-line retailers and physician and medical spa facilities. Product revenue and percentage changes for the six months ended October 31, 2012 and 2011, respectively, are as follows:
 
   
Six months ended October 31,
   
Increase/ (Decrease)
   
% Increase/ (Decrease)
 
   
2012
   
2011
             
Product revenue
  $ 26,028     $ 86,892     $ (60,864 )     (70 ) %
Cost of sales
    15,044       45,104       (30,060 )     (67 ) %
Gross profit
  $ 10,984     $ 41,788     $ (30,804 )     (74 ) %
 
The decrease in product revenue for the six months ended October 31, 2012 was primarily due to the reduction in our internal sales force and the termination of existing distribution agreements in the prior year. During the six months ended October 31, 2011, we recorded $26,000 in revenue from sales to our distributer that did not occur in the current period. During the current period, we employed only one internal salesperson compared to six during the same period in the prior year.
 
Gross profit as a percentage of revenue was 42% and 48% for six months ended October 31, 2012 and 2011, respectively. The decrease for the six months ended October 31, 2012 was due to a greater proportion of total sales through retail regional sales versus wholesale and distributor channels as compared to the same period in the prior year.
 
Government Grant Revenue
 
We earn Grant Revenue through a cost-reimbursement grant sponsored by the United States Army. Grant Revenue is recognized as milestones under the Grant program are achieved. Grant Revenue is earned through reimbursements for the direct costs of labor, travel, and supplies, as well as the pass-through costs of subcontracts with third-party CROs.
 
   
Six months ended October 31,
   
Increase/ (Decrease)
   
% Increase/ (Decrease)
 
   
2012
   
2011
             
Government grant revenue
  $ 775,984     $ 78,244     $ 697,740       892 %
 
For the six months ended October 31, 2012, we recorded an increase of approximately $698,000 in revenue under the grant program as compared to the same period in the prior year. This increase is due to the progress of the underlying studies and the achievement of contractual milestones under the grant.
 
In addition to the revenue earned, we have recorded approximately $229,000 in deferred revenue associated with the grant. Deferred revenue under the grant represents pass-through costs that have been reimbursed in advance of performing the studies underlying the subcontracts.
 
Marketing and Sales Expenses
 
Marketing and sales expenses consisted primarily of personnel-related costs, including salaries, commissions, and the costs of marketing programs aimed at increasing revenue, such as advertising, trade shows, public relations and other market development programs. Marketing and sales expenses and percentage changes for the six months ended October 31, 2012 and 2011, respectively, are as follows:
 
   
Six months ended October 31,
   
Increase/ (Decrease)
   
% Increase/ (Decrease)
 
   
2012
   
2011
             
Marketing and sales expense
  $ 91,898     $ 363,368     $ (271,470 )     (75 ) %
 
The decrease in marketing and sales expenses for the six months ended October 31, 2012 was driven primarily by a decrease in the costs incurred for compensation and direct advertising.
 
 
 
27

 
 
-  
We reduced compensation costs related to marketing and selling the cosmetic topical product line Dermacyte by approximately $146,000 compared to the same period in the prior year. These costs include salaries, commissions, and employee benefits.
 
-  
Costs related to direct marketing and advertising decreased by approximately $83,000 compared to the same period in the prior year. These costs include attendance at trade shows and conferences, fees paid to a third party public relations firm, the costs of product samples distributed to potential customers, and the costs of direct print and online advertisements.
 
-  
We reduced our travel and marketing sample expenses by approximately $42,000 during the six months ended October 31, 2012 as compared to the same period in the prior year.  This decrease was a result of our regional market focus and our reduction in overall headcount.
 
General and Administrative Expenses
 
General and administrative expenses consist primarily of compensation for executive, finance, legal and administrative personnel, including stock-based compensation. Other general and administrative expenses include facility costs not otherwise included in research and development expenses, legal and accounting services, other professional services, and consulting fees. General and administrative expenses and percentage changes for the six months ended October 31, 2012 and 2011, respectively, are as follows:
 
   
Six months ended October 31,
   
Increase/ (Decrease)
   
% Increase/ (Decrease)
 
   
2012
   
2011
             
Legal and professional fees
  $ 1,048,578     $ 1,741,371     $ (692,793 )     (40 ) %
Personnel costs
    750,632       876,869       (126,237 )     (14 ) %
Facilities
    90,815       155,690       (64,875 )     (42 ) %
Depreciation and amortization
    54,164       97,471       (43,307 )     (44 ) %
Other costs
    (350,455 )     227,030       (577,485 )     (254 ) %
 
Legal and professional fees:
 
Legal and professional fees decreased approximately $693,000 for the six months ended October 31, 2012 compared to the same period in the prior year. This decrease was primarily due to decreases of approximately $230,000 in legal fees, $165,000 in consulting fees, $155,000 in other professional fees, $103,000 in accounting and filing fees and $35,000 in investor relations costs.
 
-  
The decrease in legal expenses was due to a reduction in the costs incurred for securities matters and SEC filings, general employment matters, intellectual property and our SIX listing, partially offset by the costs incurred to defend the Tenor matter and fees associated with the second closing of the Series A Preferred Stock.
 
-  
The decrease in consulting fees was due to a reduction in Board of Director and executive recruiting fees partially and the elimination of other executive consulting expenses in the current period.
 
-  
The decrease in other professional fees was due to approximately $200,000 in severance costs related to our former President’s resignation from our Board of Directors in the prior year, partially offset by an increase of $35,000 in fees and travel costs associated with Board retainers and meetings
 
-  
The decrease in accounting and filing fees was due to a reduction in audit fees and the fees associated with our continued listing on the SIX in the prior year.
 
-  
The decrease in investor relations costs was due primarily to the fees incurred for public and investor relations services related to our continued listing on the SIX in the prior year.
 
Personnel costs:
 
Personnel costs decreased approximately $126,000 for the six months ended October 31, 2012 compared to the same period in the prior year. The decrease was due primarily to our termination of our Chief Executive Officer in the prior year.
 
Facilities:
 
Facilities include costs paid for rent and utilities at our corporate headquarters in North Carolina, the allocation of lease costs not otherwise included in Research and Development expenses, and the costs incurred for third party IT support services. Facilities expense decreased approximately $65,000 due to reductions of $41,000 in allocated lease costs associated with our California facility, $8,000 lease termination payments on our previous North Carolina office facility and $16,000 in utilities expense primarily due to fees paid to outside service providers for network and computer maintenance services.
 
 
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Depreciation and Amortization:
 
The $43,000 decrease in depreciation and amortization costs for the six months ended October 31, 2012 compared to the same period in the prior year was primarily due to assets becoming fully depreciated in the current period.
 
Other costs:
 
Other costs include costs incurred for travel, supplies, insurance and other miscellaneous charges. The $577,000 reduction in other costs was due primarily to a $532,000 reduction in our estimate of the accrued liability related to potential 409A violations and an overall decrease of $78,000 in administrative and office expenses as a result of headcount reductions, partially offset by an increase of $33,000 in insurance premiums as compared to the same period in the prior year.
 
Research and Development Expenses
 
Research and development expenses include, but are not limited to, (i) expenses incurred under agreements with CROs and investigative sites, which conduct our clinical trials and a substantial portion of our pre-clinical studies; (ii) the cost of manufacturing and supplying clinical trial materials; (iii) payments to contract service organizations, as well as consultants; (iv) employee-related expenses, which include salaries and benefits; and (v) facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities and equipment, depreciation of leasehold improvements, equipment, laboratory and other supplies. All research and development expenses are expensed as incurred. Research and development expenses and percentage changes for the six months ended October 31, 2012 and 2011, respectively, are as follows:
 
   
Six months ended October 31,
   
Increase/ (Decrease)
   
% Increase/ (Decrease)
 
   
2012
   
2011
             
Clinical and preclinical development
  $ 721,704     $ 321,891     $ 399,813       124 %
Personnel costs
    334,787       466,921       (132,134 )     (28 ) %
Consulting
    87,459       210,629       (123,170 )     (58 ) %
Other costs
    23,676       36,705       (13,029 )     (35 ) %
Depreciation
    23,522       30,514       (6,992 )     (23 ) %
Facilities
    50,698       73,878       (23,180 )     (31 ) %
 
Clinical and preclinical development:
 
The increase of approximately $400,000 in clinical and preclinical development costs for the six months ended October 31, 2012 compared to the prior year was primarily due to increases in costs associated with our pre-clinical studies and quality assurance for Oxycyte, partially offset by a reduction in costs associated with Dermacyte development.
 
-  
We incurred an increase of approximately $345,000 in pre-clinical study costs. These costs are the result of CRO fees for the completion for milestones under the Grant-funded preclinical program to assess the safety of Oxycyte for the treatment of patients with TBI.
 
-  
We incurred an increase of approximately $145,000 in Oxycyte development costs. These costs are the result of developing cGMP supply and manufacturing capabilities and validated release methods for our clinical drug product.
 
-  
We decreased Dermacyte development costs by approximately $90,000.  This decrease was primarily related to the development of additional cosmetic formulations in the prior year.
 
Personnel costs:
 
Personnel costs decreased approximately $132,000 for the six months ended October 31, 2012 compared to the same period in the prior year, primarily due to headcount reductions in the California lab facility and the resignation of our Chief Medical Officer in the prior year.
 
Consulting fees:
 
Consulting fees decreased approximately $132,000 for the six months ended October 31, 2012 compared to the same period in the prior year, primarily due to charges under the consulting and separation agreement for our former President and Chief Operating Officer that were not incurred in the current period.
 
 
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Other costs:
 
Other costs decreased approximately $13,000 for the six months ended October 31, 2012 as compared to the same period in the prior year, due primarily to a decrease of $4,000 in travel and $8,000 in supplies as a result of closing our California facility.
 
Depreciation:
 
Depreciation expense remained relatively consistent for the six months ended October 31, 2012 and 2011.
 
Facilities:
 
Facilities expense decreased approximately $23,000 for the six months ended October 31, 2012 as compared to the same period in the prior year, primarily as a result of closing our California facility.
 
Restructuring expense
 
   
Six months ended October 31,
   
Increase/ (Decrease)
   
% Increase/ (Decrease)
 
   
2012
   
2011
             
Restructuring expense
  $ 217,774     $ -     $ 217,774       %
 
During the six months ended October 31, 2012, the Company recorded one-time charges of approximately $54,000 for severance and benefits related charges, $135,000 for net future lease obligations and $29,000 for other exit costs.
 
Interest expense
 
Interest expense includes the interest payments due under our long-term debt, amortization of debt issuance costs and accretion of discounts recorded against our outstanding notes. Interest expense also includes dividends and fair-value adjustments to the carrying value on our Series A Convertible Preferred Stock. Interest expense and percentage changes for the six months ended October 31, 2012 and 2011, respectively, are as follows:
 
 
   
Six months ended October 31,
   
Increase/ (Decrease)
   
% Increase/ (Decrease)
 
   
2012
   
2011
             
Interest expense
  $ 2,793,427     $ 1,307,566     $ 1,485,861       114 %
 
Long-term notes payable:
 
Interest expense for our long-term notes payable was $0 and approximately $470,000 for the six months ended October 31, 2012 and 2011, respectively. These notes were repaid in full in November 2011.
 
Convertible notes payable:
 
Interest expense on our outstanding convertible notes was approximately $1,257,000 and $837,000 for the six months ended October 31, 2012 and 2011, respectively. The recorded interest for the six months ended October 31, 2012 was comprised of approximately $377,000 for quarterly interest payable, $816,000 for amortization of debt discounts and $64,000 for amortization of debt issue costs.
 
Series A Convertible Preferred Stock:
 
Interest expense on our outstanding Series A Convertible Preferred Stock was approximately $1,536,000 and $0 for the six months ended October 31, 2012 and 2011, respectively. The recorded interest for the six months ended October 31, 2012 was comprised of approximately $657,000 for the calculated fair value of the warrants issued with the Series A Convertible Preferred Stock, $460,000 for the excess of the fair-value of the shares issued upon conversion over the fair value of the Series A Convertible Preferred Stock and $204,000 for the fair value adjustment to the remaining Preferred Stock outstanding at October 31, 2012. There were no shares of Series A Convertible Preferred Stock outstanding during the six months ended October 31, 2011.
 
 
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Preferred Stock Dividends:
 
Interest expense recorded for the payment of dividends on the Preferred Stock was approximately $215,000 for the six months ended October 31, 2012. There were no shares of Series A Convertible Preferred Stock outstanding during the six months ended October 31, 2011.
 
Other income and expense
 
Other income and expense includes non-operating income and expense items not otherwise recorded in our statement of operations. These items include, but are not limited to, revenue earned under sublease agreements for our California facility, prior to exiting the facility on September 1, 2012, recognized gains and losses on foreign currency translations, interest income earned and fixed asset disposals. Other (income) expense for the six months ended October 31, 2012 and 2011, respectively, is as follows:
 
   
Six months ended October 31,
   
Increase/ (Decrease)
 
   
2012
   
2011
       
Other income (expense), net
  $ (7,892 )   $ 9,121     $ (17,013 )
 
Other income (expense) decreased approximately $17,000 for the six months ended October 31, 2012 compared to the same period in the prior year, primarily due to sub lease income from our California facility in the current period that was not earned in the same period during the prior year.
 
During the six months ended October 31, 2012 compared to the prior year, we recorded income from sublease agreements and interest of approximately $19,000 and $5,000, respectively. We recorded losses of approximately $12,000 and $14,000 from the disposal of fixed assets and other non-operating expenses.
 
Liquidity, Capital Resources and Plan of Operation
 
We have incurred losses since our inception and as of October 31, 2012 we had an accumulated deficit of $112.8 million. We will continue to incur losses until we generate sufficient revenue to offset our expenses, and we anticipate that we will continue to incur net losses for at least the next several years. We expect to incur increased expenses related to our development and potential commercialization of Oxycyte and other product candidates and, as a result, we will need to generate significant net product sales, royalty and other revenues to achieve profitability.
 
Liquidity
 
We have financed our operations since September 1990 through the issuance of debt and equity securities and loans from stockholders. We had $2,116,923 and $2,631,032 of total current assets and working capital of $771,633 and $(495,838) as of October 31, 2012 and April 30, 2012, respectively. Our practice is to invest excess cash, where available, in short-term money market investment instruments.
 
We are in the preclinical and clinical trial stages in the development of our product candidates. We are currently conducting Phase II-b clinical trials for the use of Oxycyte in the treatment of severe traumatic brain injury. Even if we are successful with our Phase II-b study, we must then conduct a Phase III clinical study and, if that is successful, file with the FDA and obtain approval of a Biologics License Application to begin commercial distribution, all of which will take more time and funding to complete. Our other product candidates must undergo further development and testing prior to submission to the FDA for approval to initiate clinical trials, which also requires additional funding. Management is actively pursuing private and institutional financing, as well as strategic alliances and/or joint venture agreements to obtain the necessary additional financing and reduce the cost burden related to the development and commercialization of our products though we can give no assurance that any such initiative will be successful. We expect our primary focus will be on funding the continued testing of Oxycyte, since this product is the furthest along in the regulatory review process. Our ability to continue to pursue testing and development of our products beyond January 31, 2013 depends on obtaining license income or outside financial resources. There is no assurance that we will obtain any license agreement or outside financing or that we will otherwise succeed in obtaining the necessary resources.
 
In December 2011, we entered into a Securities Purchase Agreement with certain institutional investors that provided for the sale and issuance of units (“Units”) consisting of Series A Convertible Preferred Stock and warrants in aggregate amount of up to $7.5 million in two installments (the “2011 Offering”).  The first installment of $3.5 million closed on December 12, 2011, and the second installment of $4.0 million was scheduled to have occurred in June 2012, subject to certain closing conditions. Because certain closing conditions for the second installment were not satisfied, on June 14, 2012, the Company entered into an Amendment Agreement with each of the institutional investors that, among other things, divided the remaining installment into two installments, the first additional installment to occur in June 2012 in the amount of $2.5 million and the second additional installment to occur in September 2012 in the amount of $1.5 million.
 
On June 15, 2012, the Company sold 2,500 Units for net proceeds of approximately $2.3 million upon the closing of the first additional installment. The remainder of the 2011 Offering, which may be up to $1.5 million, was scheduled to be completed in an additional closing in September 2012. However, as our stock was trading at a level below the minimum price, the additional closing did not occur.  We will need to find alternative sources of capital to continue as a going concern, and there can be no assurance that such funding will be available on favorable terms or at all.
 
Based on our working capital at October 31, 2012, we believe we have sufficient capital on hand to continue to fund operations through January 31, 2013.
 
 
31

 
 
Cash Flows
 
 
The following table shows a summary of our cash flows for the six months ended October 31, 2012 and 2011:
 
   
For the six months ended October 31,
 
   
2012
   
2011
 
Net cash used in operating activities
  $ (2,741,815 )   $ (4,583,454 )
Net cash used in investing activities
    (70,781 )     (161,475 )
Net cash provided by financing activities
    2,444,237       5,797,242  
 
Net cash used in operating activities.  Net cash used in operating activities was $2.7 million for the six months ended October 31, 2012 compared to net cash used in operating activities of $4.6 million for the six months ended October 31, 2011. The decrease in cash used for operating activities was due primarily to decreases in our overall administrative expenses, our costs associated with marketing and selling our cosmetic products and revenue received under the Army Grant; partially offset by an increase in costs incurred for research and development activities.
 
Net cash used in investing activities. Net cash used in investing activities was $70,781 for the six months ended October 31, 2012 compared to net cash used in investing activities of $161,475 for the six months ended October 31, 2011. The decrease in cash used for investing activities was due to a reduction in capitalized legal fees incurred for filing and maintaining our patent portfolio.
 
Net cash provided by financing activities. Net cash provided by financing activities was $2.4 million for the six months ended October 31, 2012 compared to net cash provided by financing activities of $5.8 million for the six months ended October 31, 2011. The decrease of net cash provided by financing activities was due primarily to net proceeds of $2.3 million received from the issuance of Preferred Stock on June 15, 2012 as compared to the $4.5 million received from the issuance of the convertible notes and the $0.7 million proceeds from the issuance of promissory notes payable under the Note Purchase Agreement with Vatea Fund during the six months ended October 31, 2011.
 
Operating Capital and Capital Expenditure Requirements
 
Our future capital requirements will depend on many factors that include, but are not limited to the following:
 
  
the initiation, progress, timing and completion of clinical trials for our product candidates and potential product candidates;
 
  
the outcome, timing and cost of regulatory approvals and the regulatory approval process;
 
  
delays that may be caused by changing regulatory requirements;
 
  
the number of product candidates that we pursue;
 
  
the costs involved in filing and prosecuting patent applications and enforcing and defending patent claims;
 
  
the timing and terms of future in-licensing and out-licensing transactions;
 
  
the cost and timing of establishing sales, marketing, manufacturing and distribution capabilities;
 
  
the cost of procuring clinical and commercial supplies of our product candidates;
 
  
the extent to which we acquire or invest in businesses, products or technologies; and
 
  
the possible costs of litigation.
 
 
32

 
 
We believe that our existing cash and cash equivalents will be sufficient to fund our projected operating requirements through January 31, 2013. We will need substantial additional capital in the future in order to complete the development and commercialization of Oxycyte and to fund the development and commercialization of our future product candidates. Until we can generate a sufficient amount of product revenue, if ever, we expect to finance future cash needs through public or private equity offerings, debt financings or corporate collaboration and licensing arrangements. Such funding, if needed, may not be available on favorable terms, if at all. In the event we are unable to obtain additional capital, we may delay or reduce the scope of our current research and development programs and other expenses.
 
To the extent that we raise additional funds by issuing equity securities, our stockholders may experience additional significant dilution, and debt financing, if available, may involve restrictive covenants. To the extent that we raise additional funds through collaboration and licensing arrangements, it may be necessary to relinquish some rights to our technologies or our product candidates or grant licenses on terms that may not be favorable to us. We may seek to access the public or private capital markets whenever conditions are favorable, even if we do not have an immediate need for additional capital.
 
Recent Accounting Pronouncements
 
On May 1, 2012, we adopted FASB Accounting Standards Update (“ASU”) 2011-05, Comprehensive Income (Topic 220): Presentation of Comprehensive Income. Under the amendments to Topic 220, Comprehensive Income, an entity has the option to present the total of comprehensive income, the components of net income, and the components of other comprehensive income either in a single continuous statement of comprehensive income or in two separate but consecutive statements. In both choices, an entity is required to present each component of net income along with total net income, each component of other comprehensive income along with a total for other comprehensive income, and a total amount for comprehensive income. This update eliminates the option to present the components of other comprehensive income as part of the statement of changes in stockholders' equity. The amendments in this update do not change the items that must be reported in other comprehensive income or when an item of other comprehensive income must be reclassified to net income. The adoption of ASU 2011-05 did not have a material impact on our financial statements.
 
On May 1, 2012, we adopted ASU 2011-04, Fair Value Measurement (Topic 820): Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRSs. The amendments in this update result in common fair value measurement and disclosure requirements in GAAP and International Financial Reporting Standards (“IFRS”). Consequently, the amendments change the wording used to describe many of the requirements in GAAP for measuring fair value and for disclosing information about fair value measurements. The amendments in this update will not result in a change in the application of the requirements in Topic 820. The adoption of ASU 2011-04 did not have a material impact on its financial statements.
 
On July 27, 2012, the FASB issued ASU 2012-02, Testing Indefinite-Lived Intangible Assets for Impairment (the revised standard). The revised standard provides companies with an option to perform a “qualitative” assessment to determine whether further impairment testing is necessary. The qualitative assessment is not an accounting policy election and can be performed on none, some, or all of a company’s indefinite-lived intangible assets. ASU 2012-02 is effective on May 1, 2013 and early adoption is permitted. We do not believe adoption of ASU 2012-02 will have a material impact on our financial statements.
 
Off-Balance Sheet Arrangements
 
Since our inception, we have not engaged in any off-balance sheet arrangements, including the use of structured finance, special purpose entities or variable interest entities.
 
ITEM 3.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
 
Management does not believe that we possess any instruments that are sensitive to market risk. Our debt instruments bear interest at fixed interest rates.
 
We believe that there have been no significant changes in our market risk exposures for the three months ended October 31, 2012.
 
 
 
33

 
 
ITEM 4.
CONTROLS AND PROCEDURES
 
Evaluation of Disclosure Controls and Procedures
 
As required by paragraph (b) of Rules 13a-15 and 15d-15 promulgated under the Exchange Act, our management, including our Interim Chief Executive Officer and Chief Financial Officer, conducted an evaluation as of the end of the period covered by this report, of the effectiveness of our disclosure controls and procedures as defined in Exchange Act Rule 13a-15(e) and 15d-15(e). Based on that evaluation, our Interim Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of October 31, 2012, the end of the period covered by this report in that they provide reasonable assurance that the information we are required to disclose in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods required by the SEC and is accumulated and communicated to our management, including the Interim Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.
 
Changes in Internal Control over Financial Reporting
 
There were no significant changes in our internal control over financial reporting during our most recently completed fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. We routinely review our internal controls over financial reporting and from time to time make changes intended to enhance the effectiveness of our internal control over financial reporting. We will continue to evaluate the effectiveness of our disclosure controls and procedures and internal controls over financial reporting on an ongoing basis and will take action as appropriate.
 
 
34

 
 
PART II – OTHER INFORMATION
 
 
ITEM 1.
LEGAL PROCEEDINGS
 
On August 30, 2011, Tenor Opportunity Master Fund Ltd., Aria Opportunity Fund, Ltd., and Parsoon Opportunity Fund, Ltd (collectively, “Tenor”) filed a lawsuit in the United States District Court for the Southern District of New York alleging that a right of first offer held by Tenor was breached in connection with our June 2011 financing. The complaint seeks compensatory damages, attorneys’ fees and costs.  Discovery was completed and motions for summary judgment from both sides were filed, Plaintiffs filed on the matter of breach and we filed on the matter of damages.  On July 11, 2012 the court entered an order on both summary judgment motions.  The court found in favor of Plaintiff’s motion, holding that we did breach the agreement.  The court did not find in favor of our motion regarding damages.  The matter will now move to trial for a jury to determine what, if any, damages Plaintiff’s suffered from our breach of the agreement. The trial was scheduled to begin on October, 10, 2012. However, on October 3, 2012 the court granted a motion from Tenor to continue the trial and it is now currently scheduled to start on March 7, 2013.
 
ITEM 1A.
RISK FACTORS
 
We are supplementing the risk factors disclosed in our Annual Report on Form 10-K for the year ended April 30, 2012 with the risk factors below.
 
Our litigation with Tenor may have a materially adverse effect on our company.
 
On August 30, 2011, Tenor filed a lawsuit in the United States District Court for the Southern District of New York alleging that a right of first offer held by Tenor was breached in connection with our June 2011 financing. The complaint seeks compensatory damages, attorneys’ fees and costs.  On July 11, 2012, the court found in favor of Plaintiff’s motion for summary judgment, holding that we breached the agreement and that we are liable for at least some damages.  The matter will now move to trial for a jury to determine what, if any more than nominal, damages Plaintiff’s suffered from our breach of the agreement.
 
We have incurred significant costs in defending this litigation, and we are likely to continue to do so until the matter is resolved.  In addition, the litigation has resulted, and likely to continue to result, in a diversion of management’s attention and resources that could otherwise have been used to advance our business plan.
 
While we continue to believe that Tenor’s claims for damages are without merit, there can be no assurance that the jury will agree with our position.  In that event, we may be held liable for significant monetary damages to Tenor, which would have a material adverse effect on our business, financial condition, or results of operations, and would potentially threaten our ability to continue as a going concern.
 
If we cannot meet the NASDAQ Capital Market continued listing requirements, our common stock may be delisted which could have an adverse impact on the liquidity and market price of our common stock.
 
Our common stock is currently listed on the NASDAQ Capital Market, or NASDAQ. Continued listing of a security on NASDAQ is conditioned upon compliance with various continued listing standards, which require, among other things, that for 30 consecutive trading days (i) the closing minimum bid price for our listed securities not be lower than $1.00 per share and (ii) our market capitalization not be lower than $35 million. The closing bid price for our shares has been less than $1.00 per share since August 21, 2012 and our market capitalization has been less than $35 million since August 8, 2012.
 
On September 20, 2012 we received a deficiency notice from NASDAQ due to our market capitalization falling below $35 million for 30 consecutive days. We are required to regain compliance with continued listing standards before March 19, 2013. On October 3, 2012 we received a deficiency notice from NASDAQ due to the closing bid price for our shares falling below $1.00 per share for 30 consecutive days. We are required to regain compliance with continued listing standards before April 1, 2013.
 
There can be no assurance made that we will be able to regain compliance during that period, and, if we do not, our common stock will be subject to delisting from the NASDAQ.  Delisting from NASDAQ would negatively impact us and our stockholders by, among other things, reducing the liquidity and market price of our common stock and adversely affecting our ability to raise additional capital.  
 
 
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The second additional closing of our December 2011 registered direct offering did not occur.
 
While our 2011 Offering provided for an aggregate amount of up to $7.5 million, only $3.5 million of the offered securities were purchased initially.  In June 2012, an additional $2.5 million of the offered securities were purchased.
 
The remainder of the 2011 Offering, which may be up to $1.5 million, was scheduled to be completed in an additional closing in September 2012. The final closing was subject to various conditions, including conditions that are outside of our control, including, but not limited to, a minimum stock price prior to the final closing and a minimum trading volume limitation. As of September 14, 2012, our stock was trading at a level below the minimum price and the final closing did not occur. We will need to find alternative sources of capital to continue as a going concern, and there can be no assurance that such funding would be available on favorable terms or at all. 
 
ITEM 2.
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
 
Repurchases of Common Stock
 
The following table lists all repurchases during the second quarter of fiscal 2013 of any of our securities registered under Section 12 of the Exchange Act by or on behalf of us or any affiliated purchaser.
 
Issuer Purchases of Equity Securities
                       
Period
 
Total Number of Shares Purchased (1)
   
Average Price Paid per Share (2)
   
Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs
   
Approximate Dollar Value of Shares that August Yet Be Purchased Under the Plans or Programs
 
 
                       
August 1, 2012 - August 31, 2012
    15,376     $ 1.82       -     $ -  
September 1, 2012 - September 30, 2012
    438       0.88       -       -  
October 1, 2012 - October 31, 2012
    438       0.60       -       -  
Total
    16,252     $ 1.76       -     $ -  
 
(1)  
Represents shares repurchased in connection with tax withholding obligations under the 1999 Amended Stock Plan.
 
(2)  
Represents the average price paid per share for the shares repurchased in connection with tax withholding obligations under the 1999 Amended Stock Plan.
 
Unregistered Sales of Equity Securities
 
On September 28, 2012, we issued 83,297 shares of unregistered common stock as payment of $187,833 of interest due on our outstanding convertible notes.
 
All of the securities described above were issued in reliance on the exemption from registration set forth in Section 4(2) of the Securities Act.
 
ITEM 3.
DEFAULTS UPON SENIOR SECURITIES
 
None.
 
ITEM 4.
MINE SAFETY DISCLOSURES
 
Not applicable.
 
 
 
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ITEM 5.
OTHER INFORMATION
 
None.
 
ITEM 6.
EXHIBITS
 
No.
Description
31.1
Certification of Chief Executive Officer and Chief Financial Officer Pursuant to Section 302 of the Sarbanes Oxley Act of 2002.
32.1
Certification of Chief Executive Officer and Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS
XBRL Instance Document (1)
101.SCH
XBRL Taxonomy Extension Schema Document (1)
101.CAL
XBRL Taxonomy Extension Calculation Linkbase Document (1)
101.DEF
XBRL Taxonomy Extension Definition Linkbase Document (1)
101.LAB
XBRL Taxonomy Extension Label Linkbase Document (1)
101.PRE
XBRL Taxonomy Extension Presentation Linkbase Document (1)
 
(1)  
Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files in Exhibit 101 hereto are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section 18 of the Exchange Act of 1934, as amended, and otherwise are not subject to liability under those sections.
 
 
 
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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.
 
 
OXYGEN BIOTHERAPEUTICS, INC.
 
       
Date: December 14, 2012
By:
/s/ Michael B. Jebsen  
   
Michael B. Jebsen
 
   
Chief Financial Officer and Interim Chief Executive Officer
 
       
 
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