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ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
12 Months Ended
Sep. 30, 2011
Notes to Financial Statements  
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

CEL-SCI Corporation (the "Company") was incorporated on March 22, 1983, in the state of Colorado, to finance research and development in biomedical science and ultimately to engage in marketing and selling products.

 

The Company’s lead investigational therapy, Multikine (Leukocyte Interleukin, Injection), is currently being developed as a potential therapeutic agent directed at using the immune system to produce an anti-tumor immune response. Data from Phase I and Phase II clinical trials suggest Multikine has the potential to directly affect tumor cells. These data also indicate that it appears to activate the patient’s own anti-tumor immune response. Multikine (Leukocyte Interleukin, Injection) is the full name of this investigational therapy, which, for simplicity, is referred to in the remainder of this document as Multikine. Multikine is the trademark that the Company has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with the Company’s future anticipated regulatory submission for approval. Multikine has not been licensed or approved by the FDA or any other regulatory agency. Neither has its safety or efficacy been established for any use.

Multikine has been cleared by the regulators in 9 countries around the world, including the U.S. FDA, for a global Phase III clinical trial in advanced primary (not yet treated) head and neck cancer patients.

Significant accounting policies are as follows:

 

a.     Principles of Consolidation--The consolidated financial statements include the accounts of the Company and its wholly owned subsidiary, Viral Technologies, Inc. (VTI). All significant intercompany transactions have been eliminated upon consolidation.

 

b.     Cash and Cash Equivalents--For purposes of the statements of cash flows, cash and cash equivalents consists principally of unrestricted cash on deposit and short-term money market funds. The Company considers all highly liquid investments with a maturity when purchased of less than three months, as cash and cash equivalents.

 

c.      Restricted Cash--The restricted cash as of September 30, 2010 was money held in escrow pursuant to the lease agreement for the manufacturing facility. The restrictions on the cash were released during the year ended September 30, 2011.

 

d.      Prepaid Expenses and Inventory--Prepaid expenses are payments for services to be rendered over a long period and are expensed over the time period for which the service is rendered. Inventory consists of manufacturing production advances and bulk purchases of laboratory supplies to be consumed in the manufacturing of the Company's product for clinical studies.

 

e.      Deposits-- The deposit on September 30, 2011 was for the manufacturing facility required by the lease agreement.

 

f.      Research and Office Equipment and Leasehold Improvements--Research and office equipment is recorded at cost and depreciated using the straight-line method over estimated useful lives of five to seven years. Leasehold improvements are depreciated over the shorter of the estimated useful life of the asset or the term of the lease. Repairs and maintenance which do not extend the life of the asset are expensed when incurred. The fixed assets are reviewed on a quarterly basis to determine if any of the assets are impaired. Depreciation expense for the years ended September 30, 2011, 2010 and 2009 totaled $447,174, $437,629, and $330,820, respectively. During the years ended September 30, 2011, 2010 and 2009, equipment with a net book value of $2,828, $2,323 and $270, respectively, was retired.

 

g.     Patents--Patent expenditures are capitalized and amortized using the straight-line method over the shorter of the expected useful life or the legal life of the patent (17 years). In the event changes in technology or other circumstances impair the value or life of the patent, appropriate adjustment in the asset value and period of amortization is made. An impairment loss is recognized when estimated future undiscounted cash flows expected to result from the use of the asset, and from disposition, is less than the carrying value of the asset. The amount of the impairment loss is the difference between the estimated fair value of the asset and its carrying value. During the years ended September 30, 2011, 2010 and 2009, the Company recorded patent impairment charges of $9,016, $13,877, and $138,525, respectively, for the net book value of patents abandoned during the year. These amounts are included in general and administrative expenses. Amortization expense for the years ended September 30, 2011, 2010 and 2009 totaled $84,142, $78,488, and $86,385, respectively. The total estimated future amortization is as follows:

 

Year ending September 30,   
2012  $86,409 
2013   86,409 
2014   86,409 
2015   45,231 
2016   8,896 
Thereafter   100,804 
   $414,158 

 

h.     Deferred Rent--Interest on the deferred rent is calculated at 3% on the funds deposited on the manufacturing facility and is included in the deferred rent. This interest income will be used to offset future rent. On September 30, 2011, the Company has included in deferred rent the following: 1) deposit on the manufacturing facility ($3,150,000); 2) the fair value of the warrants issued to lessor ($1,403,654); 3) additional investment ($2,995,541); 4) deposit on the cost of the leasehold improvements for the manufacturing facility ($1,786,591),; and 5) accrued interest on deposit ($287,668), less amortization of $2,433,614.

 

On September 30, 2010, the Company has included in deferred rent the following: 1) deposit on the manufacturing facility ($3,150,000); 2) the fair value of the warrants issued to lessor ($1,403,654); 3) additional investment ($2,976,396; 4) deposit on the cost of the leasehold improvements for the manufacturing facility ($1,786,591); and 5) accrued interest on deposit ($186,194), less amortization of $1,683,313.

 

i. Deferred Rent (liability)--The deferred rent (liability) is amortized on a straight-line basis over the term of the lease with the offset going against rent expense.

 

j. Derivative Instruments--The Company entered into financing arrangements that consisted of freestanding derivative instruments or were hybrid instruments that contained embedded derivative features. The Company accounted for this arrangement in accordance with Codification 815-10-50, “Accounting for Derivative Instruments and Hedging Activities”, “Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company's Own Stock”. In accordance with accounting principles generally accepted in the United States (“GAAP”), derivative instruments and hybrid instruments are recognized as either assets or liabilities in the Company’s balance sheet and are measured at fair value with gains or losses recognized in earnings or other comprehensive income depending on the nature of the derivative or hybrid instruments. Embedded derivatives that are not clearly and closely related to the host contract are bifurcated and recognized at fair value with changes in fair value recognized as either a gain or loss in earnings if they can be reliably measured. When the fair value of embedded derivative features cannot be reliably measured, the Company measures and reports the entire hybrid instrument at fair value with changes in fair value recognized as either a gain or loss in earnings. The Company determined the fair value of derivative instruments and hybrid instruments based on available market data using appropriate valuation models, giving consideration to all of the rights and obligations of each instrument and precluding the use of “blockage” discounts or premiums in determining the fair value of a large block of financial instruments. Fair value under these conditions does not necessarily represent fair value determined using valuation standards that give consideration to blockage discounts and other factors that may be considered by market participants in establishing fair value.

  

k. Research and Development Grant Revenues--The Company received a $733,437 grant in November 2010 under The Patient Protection and Affordable Care Act of 2010 (PPACA). The grant was related to three of the Company’s projects, including the Phase III trial of Multikine. The PPACA provides small and mid-sized biotech, pharmaceutical and medical device companies with up to a 50% tax credit for investments in qualified therapeutic discoveries for tax years 2009 and 2010 for all qualified “therapeutic discovery projects”. The Company recognizes revenue as the expenses are incurred. During the fiscal year ended September 30, 2011, the Company has earned $733,437 in PPACA grants and has receivables of $161,297 for grant money earned but not yet received. This payment was received in November 2011.

 

l. Research and Development Costs--Research and development expenditures are expensed as incurred. Total research and development costs, excluding depreciation, were $11,745,629, $11,911,626, and $6,011,750, respectively, for the years ended September 30, 2011, 2010 and 2009.

 

m. Net (Loss) Income Per Common Share—Net (loss) income per common share is computed by dividing the net (loss) income by the weighted average number of common shares outstanding during the period. Potentially dilutive common stock equivalents, including convertible preferred stock, convertible debt and options to purchase common stock, are included in the calculation of diluted net (loss) income per share unless the result is antidilutive.

 

n. Concentration of Credit Risk--Financial instruments, which potentially subject the Company to concentrations of credit risk, consist of cash and cash equivalents.  The Company maintains its cash and cash equivalents with high quality financial institutions.  At times, these accounts may exceed federally insured limits.  The Company has not experienced any losses in such bank accounts.  The Company believes it is not exposed to significant credit risk related to cash and cash equivalents. All of our non-interest bearing cash balances were fully insured at September 30, 2011 due to a temporary federal program in effect from December 31, 2010 through December 31, 2012. Under the program, there is no limit to the amount of insurance for eligible accounts. Beginning 2013, insurance coverage will revert to $250,000 per depositor at each financial institution, and our non-interest bearing cash balances may again exceed federally insured limits. Interest-bearing amounts on deposit in excess of federally insured limits at September 30, 2011 approximated $3,666,000.

 

 o. Income Taxes-- The Company uses the asset and liability method of accounting for income taxes. Under the asset and liability method, deferred tax assets and liabilities are recognized for future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating and tax loss carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. The Company records a valuation allowance to reduce the deferred tax assets to the amount that is more likely than not to be recognized.

 

p. Use of Estimates--The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Accounting for derivatives is based upon valuations of derivative instruments determined using various valuation techniques including the Black-Scholes and binomial pricing methodologies. The Company considers such valuations to be significant estimates.

 

q. Recent Accounting Pronouncements-- In January 2010, the FASB issued ASU 2010-06, “Fair Value Measurements and Disclosures”, which requires new disclosures for transfers in and out of Level 1 and Level 2 and activity in Level 3 of the fair value hierarchy. ASU 2010-06 requires separate disclosure of the amounts of significant transfers in and out of Level 1 and Level 2 fair value measurements and a description of the reasons for the transfers. In the reconciliation for fair value measurements using Level 3 inputs, a reporting entity should present separately information about purchases, sales, issuances and settlements. ASU 2010-06 is effective for new disclosures and clarification of existing disclosures for interim and annual periods beginning after December 15, 2009 except for disclosures about purchases, sales, issuances and settlements in the Level 3 activity rollforward, which are effective for fiscal years beginning after December 15, 2010, and for interim periods within those fiscal years. The adoption of ASU 2010-06 did not have a material impact on its financial statements.

 

In May 2011, the FASB Issued Accounting Standards Update (ASU) No. 2011-04, “Fair Value Measurement (Topic 820) – Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRSs”, which is effective for interim and annual periods beginning after December 15, 2011. The ASU is mainly the result of the joint efforts by the FASB and the International Accounting Standards Board to develop a single, converged fair value framework on how to measure fair value and common disclosure requirements for fair value measurements. The ASU amends various fair value guidance such as requiring the highest-and-best-use and valuation-premise concepts only to measuring the fair value of nonfinancial assets and prohibits the use of blockage factors and control premiums when measuring fair value. In addition, the ASU expands disclosure requirements particularly for Level 3 inputs and requires disclosure of the level in the fair value hierarchy of items that are not measured at fair value in the statement of financial position but whose fair value must be disclosed. The Company does not believe that this amendment will have a material impact on its financial statements

 

r. Stock-Based Compensation-- Compensation cost for all stock-based awards is measured at fair value as of the grant date. The fair value of our stock options is calculated using the Black-Scholes option pricing model. The Black-Scholes model requires various highly judgmental assumptions including volatility, forfeiture rates and expected option life. If any of the assumptions used in the Black-Scholes model change significantly, stock-based compensation expense for new awards may differ materially in the future from that recorded in the current period. The fair value of each option grant was estimated on the date of grant using the Black-Scholes option-pricing model with the following assumptions:

 

 

  2011 2010 2009
Expected stock price volatility 96.5-97%   98.6-104.5%      79.5-80.2%
Risk-free interest rate 2.97-3.68%       2.54-4.01% 2.82-3.72%
Expected life of options 9.62-9.63 Years     9.63-10 Years 10 Years
       
Expected dividend yield - - -

 

The Company’s stock options are not transferable, and the actual value of the stock options that an employee may realize, if any, will depend on the excess of the market price on the date of exercise over the exercise price. The Company has based its assumption for stock price volatility on the variance of daily closing prices of the Company's stock. The risk-free rate of return used for fiscal years 2011, 2010 and 2009 equals the yield on ten-year zero-coupon U.S. Treasury issues on the grant date. Historical data was used to estimate option exercise and employee termination within the valuation model. The expected term of options represents the period of time that options granted are expected to be outstanding and has been determined based on an analysis of historical exercise behavior. No discount was applied to the value of the grants for non-transferability or risk of forfeiture.

 

The Company recognized expense of $1,535,329 for options issued or vested during the fiscal year ended September 30, 2011, expense of $1,316,399 for options issued or vested during the fiscal year ended September 30, 2010 and expense of $1,699,448 for options issued or vested during the fiscal year ending September 30, 2009. This expense was recorded as general and administrative expense. The Company received a total of $13,056, $36,330 and $282,841 from the exercise of options during the year ended September 30, 2011, 2010 and 2009, respectively. The total intrinsic value of options exercised during the fiscal years 2011, 2010 and 2009 was $10,944, $32,999, and $242,634 respectively.

 

In fiscal year 2011, the Company issued 2,379,594 stock options to employees and directors at a fair value of $1,458,764, ($0.61 fair value per option). In fiscal year 2010, the Company issued 2,553,450 stock options to employees and directors at a fair value of $1,333,831, ($0.52 fair value per option). In fiscal year 2009, the Company issued 16,878,389 stock options to employees and directors at a fair value of $4,725,949, ($0.28 fair value per option). On September 30, 2011, the Company had 15,115,146 options that were unvested at a fair value of $5,834,830, which is a weighted average fair value of $0.39 per share with a weighted average remaining vesting life of 1.57 years.

 

Non-Qualified Stock Option Plans --At September 30, 2011, the Company has collectively authorized the issuance of 35,760,000 shares of common stock under its Non-Qualified Stock Option Plans. Options typically vest over a three-year period and expire no later than ten years after the grant date. Terms of the options are to be determined by the Company's Compensation Committee, which administers the plans. The Company's employees, directors, officers, and consultants or advisors are eligible to be granted options under the Non-Qualified Stock Option Plans.

 

Information regarding the activity in the Company's Non-Qualified Stock Option Plans for the year ended September 30, 2011 is summarized as follows:

 

Non-Qualified Stock Option Plan

 

  Outstanding     Exercisable

                     Weighted
         Weighted Ave        Weighted  Ave Remaining
   Number of  Weighted Average  Remaining Contractual  Aggregate Intrinsic  Number of  Average Exercise  Contractual Term  Aggregate Intrinsic
   Shares  Exercise Price  Term (Years)  Value  Shares  Price  (Years)  Value
Outstanding at October 1, 2010   21,720,414   $0.49    7.06   $4,365,776    8,906,473   $0.60    4.34   $1,291,973
                                    
Vested                       1,059,721   $0.53      
Granted   1,779,594   $0.69    9.58   $—                  
Exercised   (29,268)  $0.45    5.01   $10,944    (29,268)  $0.45    5.01   10,944
Forfeited   (2,000)  $0.61                          
Expired   (7,500)  $1.22              (7,500)  $1.22      
                                    
Outstanding at September 30, 2011   23,461,240   $0.51    6.35   $471,789    9,929,426   $0.62    3.93   $364,539
                                         

 

A summary of the status of the Company's non-vested options as of September 30, 2011 is presented below:

 

Non-qualified Stock Option Plan:

  Number of Shares Weighted Average Grant Date Fair Value
Unvested at September 30, 2010 12,813,941 $0.40
Vested -1,059,721  
Granted 1,779,594 $0.61
Forfeited -2,000  
     
Unvested at September 30, 2011 13,531,814 $0.37

 

 

In April 2009, the Company extended the expiration date on 147,000 options from the Nonqualified Stock Option Plans with exercise prices ranging from $1.05 to $1.87. The options originally would have expired between May 2009 and September 2009 and were extended for three years to expiration dates ranging from May 2012 to September 2012. This extension was considered a new measurement date with respect to the modified options. At the date of modification, the additional cost of the options was $2,904. As of September 30, 2011, all of these options remained outstanding.

 

In January 2010, the Company extended the expiration date on 181,666 options from the Nonqualified Stock Option Plans with exercise prices ranging from $1.05 to $1.76. The options originally would have expired between February 2010 and November 2010 and were extended for three years to expiration dates ranging from February 2013 to November 2013. This extension was considered a new measurement date with respect to the modified options. At the date of modification, the additional cost of the options was $72,632. As of September 30, 2011, all of these options remained outstanding.

 

In January 2011, the Company extended the expiration date on 146,500 options from the Nonqualified Stock Option Plans with exercise prices ranging from $1.13 to $1.51. The options originally would have expired between March 2011 and October 2011 and were extended for three years to expiration dates ranging from March 2014 to October 2014. This extension was considered a new measurement date with respect to the modified options. At the date of modification, the additional cost of the options was $55,449. As of September 30, 2011, all of these options remained outstanding.

 

Incentive Stock Option Plan--At September 30, 2011, the Company had collectively authorized the issuance of 19,100,000 shares of common stock under its Incentive Stock Option Plans. Options vest over a one-year to three-year period and expire no later than ten years after the grant date. Terms of the options were determined by the Company's Compensation Committee, which administers the plans. Only the Company's employees are eligible to be granted options under the Incentive Stock Option Plans.

 

Information regarding the activity in the Company's Incentive Stock Option Plans for the year ended September 30, 2011 is summarized as follows:

 

Incentive Stock Option Plan            
      Outstanding        Exercisable   
               Weighted   
      Weighted Ave        Ave Remaining   
   Number of  Remaining Contractual  Aggregate Intrinsic  Number of  Contractual Term  Aggregate Intrinsic
   Shares  Term (Years)  Value  Shares  (Years)  Value
Outstanding at October 1, 2010   10,593,041   $0.40    6.65   $3,101,582    8,893,042   $0.38    6.02   $2,794,276 
                                         
Vested                       716,667   $0.53           
Granted   600,000   $0.69    9.58   $—                       
Expired   (25,000)  $1.39              (25,000)  $1.39           
                                         
Outstanding at September 30, 2011   11,168,041   $0.42    5.83   $1,019,989    9,584,709   $0.38    5.29   $1,017,489 
                                         

 

 

A summary of the status of the Company's non-vested options as of September 30, 2011 is presented below:

 

Incentive Stock Option Plan:

  Number of Shares Weighted Average Grant Date Fair Value
     
Unvested at September 30, 2010 1,699,999 $0.54
Vested -716,667  
Granted 600,000 $0.61
Forfeited              -  
     
Unvested at September 30, 2011 1,583,332 $0.54

 

In April 2009, the Company extended the expiration date on 153,000 options from the Incentive Stock Option Plans with an exercise price of $1.05. The options originally would have expired between April 2009 and December 2009 and were extended for three years to expiration dates ranging from April 2012 to December 2012. This extension was considered a new measurement date with respect to the modified options. At the date of modification, the additional cost of the options was $3,238. As of September 30, 2011, all of these options remained outstanding.

 

In January 2010, the Company extended the expiration date on 337,166 options from the Incentive Stock Option Plans with exercise prices ranging from $1.05 to $1.18. The options originally would have expired between February 2010 and December 2010 and were extended for three years to expiration dates ranging from February 2013 to December 2013. This extension was considered a new measurement date with respect to the modified options. At the date of modification, the additional cost of the options was $139,812. As of September 30, 2011, all of these options remained outstanding

 

In January 2011, the Company extended the expiration date on 160,000 options from the Incentive Stock Option Plans with exercise prices ranging from $1.00 to $1.85. The options originally would have expired between January 2011 and December 2011 and were extended for three years to expiration dates ranging from January 2014 to December 2014. This extension was considered a new measurement date with respect to the modified options. At the date of modification, the additional cost of the options was $50,353. As of September 30, 2011, all of these options remained outstanding.

 

Stock Bonus Plans -- At September 30, 2011, the Company had been authorized to issue up to 13,940,000 shares of common stock under its Stock Bonus Plans. All employees, directors, officers, consultants, and advisors are eligible to be granted shares. During the year ended September 30, 2009, 91,766 shares were issued to the Company’s 401(k) plan for a cost of $57,829. During the year ended September 30, 2010, 182,233 shares were issued to the Company’s 401(k) plan for a cost of $112,325. During the year ended September 30, 2011, 294,309 shares were issued to the Company's 401(k) plan for a cost of $150,865. During the years ended September 30, 2011, 2010 and 2009, the Company also issued 71,111, 113,520 and 2,826,711 shares respectively to consultants for payment of services at a cost of $31,160, $75,200 and $731,866 respectively.

 

Stock Compensation Plan-- At September 30, 2011, 11,500,000 shares were authorized for use in the Company's stock compensation plan. During the year ended September 30, 2009, 1,324,385 shares were issued at the weighted average of $0.24 per share for a total cost of $312,016. During the year ended September 30, 2010, no shares were issued from the Stock Compensation Plan. During the year ended September 30, 2011, no shares were issued from the Stock Compensation Plan.