0001654954-17-011499.txt : 20171211 0001654954-17-011499.hdr.sgml : 20171211 20171211163753 ACCESSION NUMBER: 0001654954-17-011499 CONFORMED SUBMISSION TYPE: 10-Q/A PUBLIC DOCUMENT COUNT: 53 CONFORMED PERIOD OF REPORT: 20161231 FILED AS OF DATE: 20171211 DATE AS OF CHANGE: 20171211 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CEL SCI CORP CENTRAL INDEX KEY: 0000725363 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 840916344 STATE OF INCORPORATION: CO FISCAL YEAR END: 0930 FILING VALUES: FORM TYPE: 10-Q/A SEC ACT: 1934 Act SEC FILE NUMBER: 001-11889 FILM NUMBER: 171249885 BUSINESS ADDRESS: STREET 1: 8229 BOONE BLVD . STREET 2: SUITE 802 CITY: VIENNA STATE: VA ZIP: 22182 BUSINESS PHONE: 7035069460 MAIL ADDRESS: STREET 1: 8229 BOONE BLVD. STREET 2: SUITE 802 CITY: VIENNA STATE: VA ZIP: 22182 FORMER COMPANY: FORMER CONFORMED NAME: INTERLEUKIN 2 INC DATE OF NAME CHANGE: 19880317 10-Q/A 1 cvm_10q.htm AMENDMENT NO. 1 ON FORM 10-Q Blueprint
 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 10-Q/A
(Amendment No. 1)
 (Mark One)
☒            QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF
THE SECURITIES EXCHANGE ACT OF 1934
 
For the quarterly period ended December 31, 2016
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 001-11889
CEL-SCI CORPORATION
 
 Colorado
 
    84-0916344     
 State or other jurisdiction incorporation
 
 (IRS) Employer Identification Number
 
 8229 Boone Boulevard, Suite 802
 Vienna, Virginia 22182
 Address of principal executive offices
 (703) 506-9460
 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) had been subject to such filing requirements for the past 90 days.
Yes ☒                                                                           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 ☒ 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” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check One):
 
Large accelerated filer
Accelerated filer
Non-accelerated filer
(Do not check if a smaller reporting company)
Smaller reporting company
 
 
Emerging growth company
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
 
Indicate by check mark whether the Registrant is a shell company (as defined in Exchange Act Rule 12b-2 of the Exchange Act).
Yes ☐                                                                 No ☒
 
Class of Stock
 No. Shares Outstanding
Date
Common
 7,638,618
February 3, 2017


 
 
 
EXPLANATORY NOTE
 
In October 2008, the Company entered into an agreement whereby the Company leased a building owned by a third party. The Company accounted for the arrangement as an operating lease under ASC 840, Accounting for Leases.
 
In November 2017, the Company determined that the lease should have been treated as a financing obligation rather than an operating lease.
 
Accordingly, this amended 10-Q is filed to correct the manner in which the Company accounted for the lease. See Note I. Restatement, to the accompanying financial statements, for further information.
 
In addition, per share data, including earnings per share amounts, in this amended 10-Q have been adjusted to reflect a 1 for 25 reverse stock split which became effective on the NYSE American on June 15, 2017.
 
As a result of the error described above, management has concluded that the Company’s internal control over financial reporting and its disclosure controls and procedures were not effective as of the end of this reporting period. The effects of the material weaknesses are discussed in more detail in Item 4, Controls and Procedures.
 
 
 
 
TABLE OF CONTENTS
 
PART I FINANCIAL INFORMATION
 
Item 1.
 
Page
 
 
 
 
Condensed Balance Sheets at December 31, 2016 and September 30, 2016 (unaudited)
3
 

 
 
Condensed Statements of Operations for the three months Ended December 31, 2016 and 2015 (unaudited)
4
 

 
 
Condensed Statements of Cash Flows for the three months Ended December 31, 2016 and 2015 (unaudited)
5
 
   
 
 
Notes to Condensed Financial Statements (unaudited)
7
 
 
 
Item 2.
Management's Discussion and Analysis of Financial Condition and Results of Operations
22
 

 
Item 3.
Quantitative and Qualitative Disclosures about Market Risks
28
8
 
 
Item 4.
Controls and Procedures
28
 
 
 
PART II
 
 
 
 
 
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
29
 
 
 
Item 6.
Exhibits
29
 
 
 
 
Signatures
30
 
 
 
2
 
 
CEL-SCI CORPORATION
CONDENSED BALANCE SHEETS
(UNAUDITED)
 
 
 RESTATED 
 
 DECEMBER 31, 
 SEPTEMBER 30, 
ASSETS
 2016 
 2016 
 
   
   
CURRENT ASSETS:
   
   
     Cash and cash equivalents
 $2,386,673 
 $2,917,996 
     Receivables
  4,128 
  394,515 
     Prepaid expenses
  866,987 
  981,677 
     Deposits - current portion
  154,995 
  154,995 
     Inventory used for R&D and manufacturing
  694,504 
  1,008,642 
 
    
    
Total current assets
  4,107,287 
  5,457,825 
 
    
    
PROPERTY AND EQUIPMENT, net
  17,225,860 
  17,350,836 
PATENT COSTS, net
  247,267 
  256,547 
DEPOSITS
  1,670,917 
  1,820,917 
 
    
    
TOTAL ASSETS
 23,251,331 
 24,886,125 
 
    
    
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
    
    
 
    
    
CURRENT LIABILITIES:
    
    
  Accounts payable
 $2,741,353 
 $3,091,512 
  Accrued expenses
  319,476 
  378,672 
  Due to employees
  476,413 
  538,278 
  Derivative instruments, current portion
  249,157 
  - 
 Other current liabilities
  7,203 
  3,310 
 
    
    
  Total current liabilities
  3,793,602 
  4,011,772 
 
    
    
  Derivative instruments - net of current portion
  1,533,549 
  8,394,934 
  Lease liability
  13,062,236 
  13,011,023 
  Deferred revenue
  125,000 
  125,000 
  Other Liabilities
  42,447 
  22,609 
 
    
    
Total liabilities
  18,556,834 
  25,565,338 
 
    
    
COMMITMENTS AND CONTINGENCIES
    
    
 
    
    
STOCKHOLDERS' EQUITY (DEFICIT)
    
    
  Preferred stock, $.01 par value-200,000 shares authorized;
    
    
    -0- shares issued and outstanding
  - 
  - 
  Common stock, $.01 par value - 600,000,000 shares authorized;
    
    
    7,633,803 and 6,235,035 shares issued and outstanding
    
    
    at December 31, 2016 and September 30, 2016, respectively
  76,338 
  62,350 
  Additional paid-in capital
  286,488,128 
  284,649,559 
  Accumulated deficit
  (281,869,969)
  (285,391,122)
 
    
    
Total stockholders' equity (deficit)
  4,694,497 
  (679,213)
 
    
    
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
 23,251,331 
 24,886,125 
 
    
    
 See notes to condensed financial statements 
 
 
3
 
 
CEL-SCI CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
THREE MONTHS ENDED DECEMBER 31, 2016 and 2015
(UNAUDITED)
 
 
 RESTATED 
 
 2016 
 2015 
 
   
   
GRANT INCOME AND OTHER
 $17,258 
 $20,976 
 
    
    
OPERATING EXPENSES:
    
    
  Research and development
  3,548,257 
  4,692,908 
  General & administrative
  1,407,009 
  634,601 
 
    
    
Total operating expenses
  4,955,266 
  5,327,509 
 
    
    
OPERATING LOSS
  (4,938,008)
  (5,306,533)
 
    
    
GAIN ON DERIVATIVE INSTRUMENTS
  8,928,312 
  8,122,960 
 
    
    
INTEREST EXPENSE, NET
  (469,151)
  (483,693)
 
    
    
NET INCOME AVAILABLE TO COMMON SHAREHOLDERS
 3,521,153 
 2,332,734 
 
    
    
 
    
    
NET INCOME PER COMMON SHARE
    
    
      BASIC
 0.59 
 0.53 
      DILUTED
 0.32 
 0.53 
 
    
    
WEIGHTED AVERAGE COMMON SHARES
    
    
  OUTSTANDING
    
    
      BASIC
  5,994,431 
  4,390,740 
      DILUTED
  6,084,708 
  4,465,591 
 
    
    
 See notes to condensed financial statements 
 
 
4
 
 
CEL-SCI CORPORATION
CONDENSED STATEMENTS OF CASH FLOWS
THREE MONTHS ENDED DECEMBER 31, 2016 and 2015
(UNAUDITED)
 
 
 RESTATED 
 
 2016 
 2015 
CASH FLOWS FROM OPERATING ACTIVITIES:
   
   
  Net income
 3,521,153 
 2,332,734 
  Adjustments to reconcile net income to
    
    
    net cash used in operating activities:
    
    
      Depreciation and amortization
  159,173 
  170,177 
      Issuance of common stock and options for services
  78,553 
  329,195 
      Equity based compensation
  312,375 
  427,910 
      Common stock contributed to 401(k) plan
  38,372 
  40,995 
      Loss on retired equipment
  1,187 
  115 
      Gain on derivative instruments
  (8,928,312)
  (8,122,960)
      Capital lease interest
  51,213 
  57,468 
      (Increase)/decrease in assets:
    
    
      Receivables
  85,046 
  75,206 
      Prepaid expenses
  96,507 
  51,628 
      Inventory used for R&D and manufacturing
  314,138 
  58,798 
      Deposits
  150,000 
  150,000 
      Increase/(decrease) in liabilities:
    
    
      Accounts payable
  (75,029)
  (1,666,792)
      Accrued expenses
  (59,196)
  280,032 
      Deferred revenue
  - 
  (1,639)
      Due to employees
  17,110 
  (25,056)
      Deferred rent liability
  (1,496)
  4,245 
 
    
    
Net cash used in operating activities
  (4,239,206)
  (5,837,944)
 
    
    
CASH FLOWS FROM INVESTING ACTIVITIES:
    
    
      Purchases of equipment
  - 
  (14,831)
 
    
    
Net cash used in investing activities
  - 
  (14,831)
 
    
    
CASH FLOWS FROM FINANCING ACTIVITIES:
    
    
     Proceeds from issuance of common stock and warrants
  3,709,931 
  10,550,538 
     Payments on obligations under capital lease
  (2,048)
  (2,194)
 
    
    
Net cash provided by financing activities
  3,707,883 
  10,548,344 
 
    
    
 NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS
  (531,323)
  4,695,569 
 
    
    
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD
  2,917,996 
  5,726,682 
 
    
    
CASH AND CASH EQUIVALENTS, END OF PERIOD
 $2,386,673 
 $10,422,251 
 
    
    
 See notes to condensed financial statements. 
 
 
5
 
 
CEL-SCI CORPORATION
CONDENSED STATEMENTS OF CASH FLOWS
THREE MONTHS ENDED DECEMBER 31, 2016 and 2015
 
 SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES: 
   
 
   
   
 
 RESTATED 
 
 2016 
 2015 
Decrease in receivable due under the litigation funding arrangement offset
   
   
   by the same amount payable to the legal firm providing the services
 $305,341 
 $366,267 
Research and office equipment included in accounts payable
  - 
  6,814 
Capital lease payments included in accounts payable
  372 
  739 
Property and equipment acquired through capital lease
  26,104 
  - 
Fair value of warrants issued in connection with public offering
  2,316,084 
  5,060,771 
Financing costs included in accounts payable
  77,987 
  21,000 
Prepaid consulting services paid with issuance of common stock
  (18,183)
  8,177 
 
    
    
 
    
    
 
    
    
  Cash paid for interest expense
 469,366 
 504,798 
 
    
    
 See notes to condensed financial statements 
 
 
6
 
 
CEL-SCI CORPORATION
NOTES TO CONDENSED FINANCIAL STATEMENTS
THREE MONTHS ENDED DECEMBER 31, 2016 AND 2015 (UNAUDITED)
 
A.            
BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
 
Basis of Presentation
 
The accompanying condensed financial statements of CEL-SCI Corporation (the Company) are unaudited and certain information and footnote disclosures normally included in the annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been omitted pursuant to the rules and regulations of the Securities and Exchange Commission. While management of the Company believes that the disclosures presented are adequate to make the information presented not misleading, these interim condensed financial statements should be read in conjunction with the financial statements and notes included in the Company’s annual report on Form 10-K for the year ended September 30, 2016.
 
In the opinion of management, the accompanying unaudited condensed financial statements contain all accruals and adjustments (each of which is of a normal recurring nature) necessary for a fair presentation of the Company’s financial position as of December 31, 2016 and the results of its operations for the three months then ended. The condensed balance sheet as of September 30, 2016 is derived from the September 30, 2016 audited financial statements. Significant accounting policies have been consistently applied in the interim financial statements and the annual financial statements. The results of operations for the three months ended December 31, 2016 and 2015 are not necessarily indicative of the results to be expected for the entire year.
 
The financial statements have been prepared assuming that the Company will continue as a going concern, but due to recurring losses from operations and future liquidity needs, there is substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. Refer to discussion in Note B.
 
Summary of Significant Accounting Policies:
 
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.
 
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 its disposition, is less than the carrying value of the asset. The amount of the impairment loss would be the difference between the estimated fair value of the asset and its carrying value.
 
 
7
 
 
Research and Development Costs - Research and development costs are expensed as incurred.
 
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.  A full valuation allowance was recorded against the deferred tax assets as of December 31, 2016 and September 30, 2016.
 
Derivative Instruments – The Company has entered into financing arrangements that consist of freestanding derivative instruments that contain embedded derivative features. The Company accounts for these arrangements in accordance with Accounting Standards Codification (ASC) 815, “Accounting for Derivative Instruments and Hedging Activities.” In accordance with accounting principles generally accepted in the United States (U.S. GAAP), derivative instruments and hybrid instruments are recognized as either assets or liabilities in the 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. The Company determines 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. The derivative liabilities are re-measured at fair value at the end of each interim period as long as they are outstanding.
 
Deferred Rent– Certain of the Company’s operating leases provide for minimum annual payments that adjust over the life of the lease.  The aggregate minimum annual payments are expensed on a straight-line basis over the minimum lease term. The Company recognizes a deferred rent liability for rent escalations when the amount of straight-line rent exceeds the lease payments, and reduces the deferred rent liability when the lease payments exceed the straight-line rent expense.  For tenant improvement allowances and rent holidays, the Company records a deferred rent liability and amortizes the deferred rent over the lease term as a reduction to rent expense.
 
Leases – Leases are categorized as either operating or capital leases at inception. Operating lease costs are recognized on a straight-line basis over the term of the lease. An asset and a corresponding liability for the capital lease obligation are established for the cost of capital leases. The capital lease obligation is amortized over the life of the lease. For build-to-suit leases, the Company establishes an asset and liability for the estimated construction costs incurred to the extent that it is involved in the construction of structural improvements or takes construction risk prior to the commencement of the lease. Upon occupancy of facilities under build-to-suit leases, the Company assesses whether these arrangements qualify for sales recognition under the sale-leaseback accounting guidance. If a lease does not meet the criteria to qualify for a sale-leaseback transaction, the established asset and liability remain on the Company's balance sheet.
 
Stock-Based Compensation – Compensation cost for all stock-based awards is measured at fair value as of the grant date in accordance with the provisions of ASC 718 “Compensation – Stock Compensation.” The fair value of stock options is calculated using the Black-Scholes option pricing model. The Black-Scholes model requires various judgmental assumptions including volatility and expected option life. The stock-based compensation cost is recognized on the straight line allocation method as expense over the requisite service or vesting period.
 
 
8
 
 
Equity instruments issued to non-employees are accounted for in accordance with ASC 505-50, “Equity-Based Payments to Non Employees.” Accordingly, compensation is recognized when goods or services are received and is measured using the Black-Scholes valuation model. The Black-Scholes model requires various judgmental assumptions regarding the fair value of the equity instruments at the measurement date and the expected life of the options.
 
The Company has Incentive Stock Option Plans, Non-Qualified Stock Option Plans, a Stock Compensation Plan, Stock Bonus Plans and an Incentive Stock Bonus Plan. In some cases, these Plans are collectively referred to as the "Plans". All Plans have been approved by the stockholders.
 
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 interest rate assumption was based on the U.S. Treasury rate at date of the grant with term equal to the expected life of the option. 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. 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.
 
Vesting of restricted stock granted under the Incentive Stock Bonus Plan is subject to service, performance and market conditions and meets the classification of equity awards. These awards were measured at market value on the grant-dates for issuances where the attainment of performance criteria is likely and at fair value on the grant-dates, using a Monte Carlo simulation for issuances where the attainment of performance criteria is uncertain. The total compensation cost will be expensed over the estimated requisite service period.
 
New Accounting Pronouncements
 
In February 2016, the FASB issued ASU 2016-02, Leases, which will require most leases (with the exception of leases with terms of less than one year) to be recognized on the balance sheet as an asset and a lease liability. Leases will be classified as an operating lease or a financing lease. Operating leases are expensed using the straight-line method whereas financing leases will be treated similarly to a capital lease under the current standard. The new standard will be effective for annual and interim periods, within those fiscal years, beginning after December 15, 2018, but early adoption is permitted. The new standard must be presented using the modified retrospective method beginning with the earliest comparative period presented. The Company is currently evaluating the effect of the new standard on its financial statements and related disclosures.
 
 
9
 
 
B.            
OPERATIONS AND FINANCING
 
The Company has incurred significant costs since its inception in connection with the acquisition of certain patented and unpatented proprietary technology and know-how relating to the human immunological defense system, patent applications, research and development, administrative costs, construction of laboratory facilities, and clinical trials.  The Company has funded such costs with proceeds from loans and the public and private sale of its common stock.  The Company will be required to raise additional capital or find additional long-term financing in order to continue with its research efforts.  Currently, the partial clinical hold has had a significant impact on the Company’s market capital, and as such, may impact the Company’s ability to attract new capital. To date, the Company has not generated any revenue from product sales.  The ability of the Company to complete the necessary clinical trials and obtain US Food & Drug Administration (FDA) approval for the sale of products to be developed on a commercial basis is uncertain. Ultimately, the Company must complete the development of its products, obtain the appropriate regulatory approvals and obtain sufficient revenues to support its cost structure.
 
The Company is currently running a large multi-national Phase 3 clinical trial for head and neck cancer with its partners TEVA Pharmaceuticals and Orient Europharma. During the three months ended December 31, 2016, the Company raised approximately $3.7 million net proceeds from a public offering. To finance the study beyond the next twelve months, the Company plans to raise additional capital in the form of corporate partnerships, debt and/or equity financings. The Company believes that it will be able to obtain additional financing because it has done so consistently in the past and because Multikine is a product in the Phase 3 clinical trial stage. However, there can be no assurance that the Company will be successful in raising additional funds on a timely basis or that the funds will be available to the Company on acceptable terms or at all.  If the Company does not raise the necessary amounts of money, it will either have to slow or delay the Phase 3 clinical trial or even significantly curtail its operations until such time as it is able to raise the required funding. The Phase 3 study is currently on partial clinical hold by the FDA. The financial statements have been prepared assuming that the Company will continue as a going concern, but due to recurring losses from operations and future liquidity needs, there is substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
 
Since the Company launched its Phase 3 clinical trial for Multikine, the Company has spent approximately $36.0 million as of December 31, 2016 on direct costs for the Phase 3 clinical trial.  The total remaining cash cost of the clinical trial is estimated to be approximately $13.5 million.  It should be noted that this estimate is based only on the information currently available in the Company’s contracts with the Clinical Research Organizations responsible for managing the Phase 3 clinical trial and does not include other related costs, e.g. the manufacturing of the drug.  This number can be affected by the speed of enrollment, foreign currency exchange rates and many other factors, some of which cannot be foreseen.  The Company has filed an amendment to the original Phase 3 protocol for it head and neck cancer study with the FDA to allow for this expansion in patient enrollment. Should the FDA allow the amended protocol filed with them to proceed, the remaining cost of the Phase 3 clinical trial will be higher. It is therefore possible that the cost of the Phase 3 clinical trial will be higher than currently estimated.
 
As of December 31, 2016, the Phase 3 clinical trial for Multikine was on a partial clinical hold.
 
 
10
 
 
If the partial clinical hold is not lifted, the Phase 3 study will not be able to be completed to its prespecified endpoints in a timely manner, if at all, and, if the Phase 3 study cannot be completed to its prespecified endpoints, the study would not be able to be used as the pivotal study supporting a marketing application in the United States, and at least one entirely new Phase 3 pivotal study would need to be conducted to provide the pivotal study supporting a marketing application in the United States. Even if the partial clinical hold is lifted, if it is not lifted in a timely fashion, the nature and duration of the partial clinical hold could irreparably harm the data from the Phase 3 study such that it may no longer be able to be used as the pivotal study supporting a marketing application in the United States. Even if the partial clinical hold is lifted in a timely fashion, it remains possible that the regulatory authorities could determine that the Phase 3 study is not sufficient to be used as a single pivotal study supporting a marketing application in the United States.
 
C.            
STOCKHOLDERS’ EQUITY
 
Stock options, stock bonuses and compensation granted by the Company as of December 31, 2016 are as follows:
 
Name of Plan
 Total Shares Reserved Under Plans 
 Shares Reserved for Outstanding Options 
 Shares Issued 
 Remaining Options/Shares Under Plans 
 
   
   
   
   
Incentive Stock Options Plans
  138,400 
  65,959 
  N/A 
  60,453 
Non-Qualified Stock Option Plans
  387,200 
  262,531 
  N/A 
  95,564 
Stock Bonus Plans
  223,760 
  N/A 
  160,157 
  63,570 
Stock Compensation Plan
  134,000 
  N/A 
  83,490 
  49,188 
Incentive Stock Bonus Plan
  640,000 
  N/A 
  624,000 
  16,000 
 
Stock options, stock bonuses and compensation granted by the Company as of September 30, 2016 are as follows:
 
Name of Plan
 Total Shares Reserved Under Plans 
 Shares Reserved for Outstanding Options 
 Shares Issued 
 Remaining Options/Shares Under Plans 
 
   
   
   
   
Incentive Stock Option Plans
  138,400 
  65,959 
  N/A 
  60,453 
Non-Qualified Stock Option Plans
  387,200 
  277,613 
  N/A 
  82,370 
Bonus Plans
  223,760 
  N/A 
  26,448 
  97,278 
Stock Compensation Plan
  134,000 
  N/A 
  79,401 
  53,276 
Incentive Stock Bonus Plan
  640,000 
  N/A 
  624,000 
  16,000 
 
Stock option activity:
 
 Three Months Ended December 31, 
 
 2016 
 2015 
Granted
  - 
  - 
Expired
  15,081
  - 
Forfeited
  - 
  919
 
Stock-Based Compensation Expense
 
 Three months Ended December 31, 
 
 2016 
 2015 
Employees
 $312,375 
 $427,910 
Non-employees
 $78,553 
 $329,195 
 
 
11
 
 
Employee compensation expense includes the expense related to options issued or vested and restricted stock. Non-employee expense includes the expense related to options and stock issued to consultants expensed over the period of their service contracts.
 
Warrants and Non-employee Options
 
The following chart presents the outstanding warrants and non-employee options, listed by expiration date at December 31, 2016:
 
Warrant
 
Issue Date
 Shares Issuable upon Exercise of Warrant 
 Exercise Price 
Expiration Date
 Refer-ence 
 
 
 
   
   
 
   
Series P
 
2/10/12
  23,600 
 112.50 
3/6/17
   
Series DD
 
12/8/16
  1,360,960 
 4.50 
6/8/17
  1 
Series EE
 
12/8/16
  1,360,960 
 4.50 
9/8/17
  1 
Series N
 
8/18/08
  113,785 
 13.18 
8/18/17
    
Series U
 
4/17/14
  17,821 
 43.75 
10/17/17
  1 
Series S
 
10/11/13 -10/24/14
  1,037,120 
 31.25 
10/11/18
  1 
Series V
 
5/28/15
  810,127 
 19.75 
5/28/20
  1 
Series W
 
10/28/15
  688,930 
 16.75 
10/28/20
  1 
Series X
 
1/13/16
  120,000 
 9.25 
1/13/21
    
Series Y
 
2/15/16
  26,000 
 12.00 
2/15/21
    
Series Z
 
5/23/16
  264,000 
 13.75 
11/23/21
  1 
Series ZZ
 
5/23/16
  20,000 
 13.75 
5/18/21
  1 
Series BB
 
8/26/16
  16,000 
 13.75 
8/22/21
  1 
Series FF
 
12/8/16
  68,048 
 4.00 
12/1/21
  1 
Series CC
 
12/8/16
  680,480 
 5.00 
12/8/21
  1 
Series AA
 
8/26/16
  200,000 
 13.75 
2/22/22
  1 
Consultants
 
3/6/12- 7/1/16
  23,000 
 9.25- $87.50 
3/5/17- 6/30/19
  2 
 
1.
Derivative Liabilities
 
The table below presents the warrant liabilities and their respective balances at the balance sheet dates:
 
 
 December 31, 2016 
 September 30, 2016 
Series S warrants
 $490,040 
 $3,111,361 
Series U warrants
  - 
  - 
Series V warrants
  202,532 
  1,620,253 
Series W warrants
  132,254 
  1,799,858 
Series Z warrants
  101,817 
  970,604 
Series ZZ warrants
  6,725 
  70,609 
Series AA warrants
  84,092 
  763,661 
Series BB warrants
  5,916 
  58,588 
Series CC warrants
  455,931 
  - 
Series DD warrants
  72,353 
  - 
Series EE warrants
  176,804 
  - 
Series FF warrants
  54,242 
  - 
 
    
    
Total warrant liabilities
 $1,782,706 
 $8,394,934 
 
 
12
 
 
The table below presents the gains on the warrant liabilities for the three months ended December 31:
 
 
 2016 
 2015 
Series S warrants
 $2,621,321 
 $2,826,153 
Series U warrants
  - 
  31,186 
Series V warrants
  1,417,721 
  3,240,506 
Series W warrants
  1,667,604 
  2,025,115 
Series Z warrants
  868,787 
  - 
Series ZZ warrants
  63,884 
  - 
Series AA warrants
  679,569 
  - 
Series BB warrants
  52,672 
  - 
Series CC warrants
  604,492 
  - 
Series DD warrants
  370,919 
  - 
Series EE warrants
  514,603 
  - 
Series FF warrants
  66,740 
  - 
 
    
    
Net gain on warrant liabilities
 $8,928,312 
 $8,122,960 
 
The Company reviews all outstanding warrants in accordance with the requirements of ASC 815. This topic provides that an entity should use a two-step approach to evaluate whether an equity-linked financial instrument (or embedded feature) is indexed to its own stock, including evaluating the instrument’s contingent exercise and settlement provisions. The warrant agreements provide for adjustments to the exercise price for certain dilutive events. Under the provisions of ASC 815, the warrants are not considered indexed to the Company’s stock because future equity offerings or sales of the Company’s stock are not an input to the fair value of a “fixed-for-fixed” option on equity shares, and equity classification is therefore precluded.
 
In accordance with ASC 815, derivative liabilities must be measured at fair value upon issuance and re-valued at the end of each reporting period through expiration. Any change in fair value between the respective reporting dates is recognized as a gain or loss.
 
 
13
 
 
Issuance of additional Warrants
 
On December 8, 2016, the Company sold 1,360,960 shares of common stock and warrants to purchase common stock at a price of $3.13 in a public offering. The warrants consist of 680,480 Series CC warrants to purchase 680,480 shares of common stock, 1,360,960 Series DD warrants to purchase 1,360,960 shares of common stock and 1,360,960 Series EE warrants to purchase 1,360,960 shares of common stock. The Series CC warrants are immediately exercisable, expire in five-years from the offering date and have an exercise price of $5.00 per share. The Series DD warrants are immediately exercisable, expire in six-months from the offering date and have an exercise price of $4.50 per share. The Series EE warrants are immediately exercisable, expire in nine-months from the offering date and have an exercise price of $4.50 per share. In addition, the Company issued 68,048 Series FF warrants to purchase 68,048 shares of common stock to the placement agent. The FF warrants are exercisable at any time on or after June 8, 2017 and expire on December 1, 2021 and have an exercise price $3.91. The net proceeds from this offering was approximately $3.7 million. The fair value of the Series CC, DD, EE and FF warrants of approximately $2.3 million on the date of issuance was recorded as a warrant liability.
 
Expiration of Warrants
 
On December 6, 2016, 105,000 Series R warrants, with an exercise price of $100.00, expired. The fair value of the Series R warrants was $0 on the date of expiration.
 
On December 22, 2015, 48,000 Series Q warrants, with an exercise price of $125.00, expired. The fair value of the Series Q warrants was $0 on the date of expiration.
 
2.
Options and shares issued to Consultants
 
The Company typically enters into consulting arrangements in exchange for common stock or stock options. During the three months ended December 31, 2016, the Company issued 14,900 shares of common stock, of which 10,800 were restricted shares. The common stock was issued with stock prices ranging between $2.25 and $7.25 per share. During the three months ended December 31, 2015, the Company issued 17,700 shares of common stock, of which 13,600 were restricted shares. The common stock was issued with stock prices ranging between $10.25 and $18.00 per share. Additionally, during the three months ended December 31, 2015, the Company issued a consultant 6,000 options to purchase common stock at $15.00 per share and a fair value of $7.50 per share. The aggregate values of the issuances of restricted common stock and common stock options are recorded as prepaid expenses and are charged to general and administrative expenses over the periods of service.
 
During the three months ended December 31, 2016 and 2015, the Company recorded total expense of approximately $79,000 and $329,000, respectively, relating to these consulting agreements. At December 31, 2016 and September 30, 2016, approximately $30,000 and $48,000, respectively, are included in prepaid expenses. As of December 31, 2016, the Company had 23,000 options outstanding, which were issued to consultants as payment for services. Of these 23,000 outstanding options, 19,000 were vested, all of which were issued from the Non-Qualified Stock Option plans.
 
D.            
FAIR VALUE MEASUREMENTS
 
In accordance with ASC 820-10, “Fair Value Measurements,” the Company determines fair value 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 Company generally applies the income approach to determine fair value. This method uses valuation techniques to convert future amounts to a single present amount. The measurement is based on the value indicated by current market expectations with respect to those future amounts.
 
 
14
 
 
ASC 820-10 establishes a fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy gives the highest priority to active markets for identical assets and liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The Company classifies fair value balances based on the observability of those inputs. The three levels of the fair value hierarchy are as follows:
 
Level 1 – Observable inputs such as quoted prices in active markets for identical assets or liabilities
Level 2 – Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and amounts derived from valuation models where all significant inputs are observable in active markets
Level 3 – Unobservable inputs that reflect management’s assumptions
 
For disclosure purposes, assets and liabilities are classified in their entirety in the fair value hierarchy level based on the lowest level of input that is significant to the overall fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment and may affect the placement within the fair value hierarchy levels.
 
The table below sets forth the assets and liabilities measured at fair value on a recurring basis, by input level, in the condensed balance sheet at December 31, 2016:
 
 
 Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1) 
 Significant Other Observable Inputs (Level 2) 
 Significant Unobservable Inputs (Level 3) 
 Total 
 
   
   
   
   
Derivative instruments
 $490,040 
 $- 
 $1,292,666 
 $1,782,706 
 
The table below sets forth the assets and liabilities measured at fair value on a recurring basis, by input level, in the condensed balance sheet at September 30, 2016:
 
 
 Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1) 
 Significant Other Observable Inputs (Level 2) 
 Significant Unobservable Inputs (Level 3) 
 Total 
 
   
   
   
   
Derivative instruments
 $3,111,361 
 $- 
 $5,283,573 
 $8,394,934 
 
 
15
 
 
The following sets forth the reconciliation of beginning and ending balances related to fair value measurements using significant unobservable inputs (Level 3) for the three months ended December 31, 2016 and the year ended September 30, 2016:
 
 
 (3 months ended) 
 (12 months ended) 
 
 December 31, 2016 
 September 30, 2016 
 
   
   
Beginning balance
 $5,283,573 
 $6,323,032 
Issuances
  2,316,084 
  8,722,073 
Realized and unrealized gains
  (6,306,991)
  (9,761,532)
Ending balance
 $1,292,666 
 $5,283,573 
 
    
    
The fair values of the Company’s derivative instruments disclosed above under Level 3 are primarily derived from valuation models where significant inputs such as historical price and volatility of the Company’s stock, as well as U.S. Treasury Bill rates, are observable in active markets.
 
E.            
RELATED PARTY TRANSACTIONS
 
Effective August 31, 2016, Maximilian de Clara, the Company’s then President and a director, resigned for health reasons. In payment for past services, the Company agreed to issue Mr. de Clara 26,000 shares of restricted stock; 13,000 shares upon his resignation and 13,000 on August 31, 2017. At December 31, 2016 and September 30, 2016, the fair value accrued for unissued shares was approximately $22,000 and $101,000, respectively.
 
On January 13, 2016, the de Clara Trust demanded payment on a note payable, of which the balance, including accrued and unpaid interest, was approximately $1.1 million. The de Clara Trust was established by Maximilian de Clara, the Company’s former President and a director. The Company’s Chief Executive Officer, Geert Kersten, is the trustee and a beneficiary. When the de Clara Trust demanded payment on the note, the Company sold 120,000 shares of its common stock and 120,000 Series X warrants to the de Clara Trust for approximately $1.1 million. Each warrant allows the de Clara Trust to purchase one share of the Company's common stock at a price of $9.25 per share at any time on or before January 13, 2021.
 
During the three months ended December 31, 2016 and 2015, the Company paid approximately $0 and $33,000, respectively, in interest expense to Mr. de Clara.
 
F.            
COMMITMENTS AND CONTINGENCIES
 
Clinical Research Agreements
 
In March 2013, the Company entered into an agreement with Aptiv Solutions, Inc. (which was subsequently acquired by ICON Inc.) to provide certain clinical research services in accordance with a master service agreement. The Company will reimburse ICON for costs incurred. The agreement required the Company to make $600,000 in advance payments which are being credited against future invoices in $150,000 annual increments through December 2017. As of December 31, 2016, the total balance advanced is $150,000, which is classified as a current asset.
 
 
16
 
 
In April 2013, the Company entered into a co-development and revenue sharing agreement with Ergomed. Under the agreement, Ergomed will contribute up to $10 million towards the study in the form of offering discounted clinical services in exchange for a single digit percentage of milestone and royalty payments, up to a specific maximum amount. In October 2015, the Company entered into a second co-development and revenue sharing agreement with Ergomed for an additional $2 million, for a total of $12 million. The Company accounted for the co-development and revenue sharing agreement in accordance with ASC 808 “Collaborative Arrangements”. The Company determined the payments to Ergomed are within the scope of ASC 730 “Research and Development.” Therefore, the Company records the discount on the clinical services as a credit to research and development expense on its Statements of Operations. Since the Company entered into the co-development and revenue sharing agreement with Ergomed, it has incurred research and development expenses of approximately $20.4 million related to Ergomed’s services. This amount is net of Ergomed’s discount of approximately $6.6 million. During the three months ended December 31, 2016 and 2015, the Company recorded, net of Ergomed’s discount, approximately $1.3 million and $2.0 million, respectively, as research and development expense related to Ergomed’s services.
 
In October 2013, the Company entered into two co-development and profit sharing agreements with Ergomed.  One agreement supports the Phase 1 study being conducted at the University of California, San Francisco, or UCSF, for the development of Multikine as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women.  The Phase 1 study originally started after the Company signed a cooperative research and development agreement with the U.S. Naval Medical Center, San Diego. In August 2016, the U.S. Navy discontinued this Phase 1 study because of difficulties in enrolling patients. The other agreement focuses on the development of Multikine as a potential treatment for cervical dysplasia in HIV/HPV co-infected women. Ergomed will assume up to $3 million in clinical and regulatory costs for each study.
 
The Company is currently involved in a pending arbitration proceeding, CEL-SCI Corporation v. inVentiv Health Clinical, LLC (f/k/a PharmaNet LLC) and PharmaNet GmbH (f/k/a PharmaNet AG). The Company initiated the proceedings against inVentiv Health Clinical, LLC, or inVentiv, the former third-party CRO, and are seeking payment for damages related to inVentiv’s prior involvement in the Phase 3 clinical trial of Multikine. The arbitration claim, initiated under the Commercial Rules of the American Arbitration Association, alleges (i) breach of contract, (ii) fraud in the inducement, and (iii) common law fraud. Currently, the Company is seeking at least $50 million in damages in its amended statement of claim.
 
In an amended statement of claim, the Company asserted the claims set forth above as well as an additional claim for professional malpractice.  The arbitrator subsequently granted inVentiv’s motion to dismiss the professional malpractice claim based on the “economic loss doctrine” which, under New Jersey law, is a legal doctrine that, under certain circumstances, prohibits bringing a negligence-based claim alongside a claim for breach of contract.  The arbitrator denied the remainder of inVentiv’s motion, which had sought to dismiss certain other aspects of the amended statement of claim.  In particular, the arbitrator rejected inVentiv’s argument that several aspects of the amended statement of claim were beyond the arbitrator’s jurisdiction.
 
 
17
 
 
In connection with the pending arbitration proceedings, inVentiv has asserted counterclaims against the Company for (i) breach of contract, seeking at least $2 million in damages for services allegedly performed by inVentiv; (ii) breach of contract, seeking at least $1 million in damages for the alleged use of inVentiv’s name in connection with publications and promotions in violation of the parties’ contract; (iii) opportunistic breach, restitution and unjust enrichment, seeking at least $20 million in disgorgement of alleged unjust profits allegedly made by the Company as a result of the purported breaches referenced in subsection (ii); and (iv) defamation, seeking at least $1 million in damages for allegedly defamatory statements made about inVentiv. The Company believes inVentiv’s counterclaims are meritless and intends to vigorously defend against them. However, if such defense is unsuccessful, and inVentiv successfully asserts any of its counterclaims, such an adverse determination could have a material adverse effect on the Company’s business, results, financial condition and liquidity.
 
In October 2015 the Company signed an arbitration funding agreement with a company established by Lake Whillans Litigation Finance, LLC, a firm specializing in funding litigation expenses. Pursuant to the agreement, an affiliate of Lake Whillans provides the Company with up to $5 million in funding for litigation expenses to support its arbitration claims against inVentiv. The funding is available to the Company to fund the expenses of the ongoing arbitration and will only be repaid if the Company receives proceeds from the arbitration. During the three months ended December 31, 2015, the Company recognized a gain of approximately $1.1 million on the derecognition of legal fees to record the transfer of the liability that existed prior to the execution of the financing agreement from the Company to Lake Whillans. The gain on derecognition of legal fees is recorded as a reduction of general and administration expenses on the Statement of Operations. All related legal fees are directly billed to and paid by Lake Whillans. As part of the agreement with Lake Whillans, the law firm agreed to cap its fees and expenses for the arbitration at $5 million.
 
The arbitration hearing on the merits began on September 26, 2016.
 
Lease Agreements
 
The Company leases a manufacturing facility near Baltimore, Maryland (the San Tomas lease). The building was remodeled in accordance with the Company’s specifications so that it can be used by the Company to manufacture Multikine for the Company’s Phase 3 clinical trial and sales of the drug if approved by the FDA. The lease is for a term of twenty years and requires annual base rent to escalate each year at 3%. The Company is required to pay all real estate and personal property taxes, insurance premiums, maintenance expenses, repair costs and utilities. The lease allows the Company, at its election, to extend the lease for two ten-year periods or to purchase the building at the end of the 20-year lease. The Company contributed approximately $9.3 million towards the tenant-directed improvements, of which $3.2 million is being refunded during years six through twenty through reduced rental payments. The landlord paid approximately $11.9 million towards the purchase of the building, land and the tenant-directed improvements. The Company placed the building in service in October 2008.
 
The leased building is being depreciated using a straight line method over the 20 year lease term to a residual value. The landlord liability is being amortized over the 20 years using the effective interest method. Lease payments allocated to the landlord liability are accounted for as debt service payments on that liability using the finance method of accounting per ASC 840-40-55.
 
The Company was required to deposit the equivalent of one year of base rent in accordance with the lease. When the Company meets the minimum cash balance required by the lease, the deposit will be returned to the Company. The approximate $1.7 million deposit is included in non-current assets at December 31, 2016 and September 30, 2016.
 
 Future minimum lease payments under the San Tomas lease as of December 31, 2016 are as follows:
 
 Nine months ending September 30, 2017   
 $1,269,000
 Year ending September 30,
    
 2018
 1,747,000
 2019
  1,808,000 
 2020
  1,872,000 
 2021
  1,937,000 
 2022
  2,004,000 
 Thereafter
  13,758,000 
 Total future minimum lease obligation
 24,395,000
 Less imputed interest on financing obligation
  (11,333,000)
 Net present value of lease financing obligation
  13,062,000 
 
 
 
18
 
 
The Company subleases a portion of its rental space on a month-to-month term lease, which requires a 30 day notice for termination. The Company receives approximately $6,000 per month in rent for the sub-leased space.
 
The Company leases its research and development laboratory under a 60 month lease which expires February 28, 2017. In September 2016, the lease was extended through February 28, 2022. The operating lease includes escalating rental payments. The Company is recognizing the related rent expense on a straight line basis over the full 60 month term of the lease at the rate of approximately $11,000 per month. As of December 31, 2016 and September 30, 2016, the Company has recorded a deferred rent liability of approximately $1,000 and $2,000, respectively.
 
The Company leases its office headquarters under a 60 month lease which expires June 30, 2020. The operating lease includes escalating rental payments. The Company is recognizing the related rent expense on a straight line basis over the full 60 month term of the lease at the rate approximately $8,000 per month. As of December 31, 2016 and September 30, 2016, the Company has recorded a deferred rent liability of approximately $18,000.
 
As of December 31, 2016, material contractual obligations, excluding the San Tomas lease, consisting of operating lease payments are as follows:
 
Nine months ending September 30, 2017
 $183,000
Year ending September 30,
    
2018
  251,000
2019
  258,000
2020
  238,000
2021
  163,000
2022
  69,000
Total
 $1,162,000
 
During the three months ended December 31, 2016, the Company leased office equipment under a capital lease arrangement. The term of the capital lease is 60 months and expires on October 31, 2021. The monthly lease payment is $505. The lease bears interest at approximately 6.25% per annum. The Company’s previous equipment lease expired on September 30, 2016.
 
G.            
PATENTS
 
During the three months ended December 31, 2016 and 2015, no patent impairment charges were recorded. For the three months ended December 31, 2016 and 2015, amortization of patent costs totaled approximately $9,000. The total estimated future amortization expense is as follows:
 
Nine months ending September 30, 2017
 $27,433 
Year ending September 30,
    
2018
  36,379 
2019
  34,676 
2020
  31,483 
2021
  28,183 
2022
  24,380 
Thereafter
  64,733 
Total
 $247,267 
 
 
19
 
 
H.            
EARNINGS PER COMMON SHARE
 
The following table provides the details of the basic and diluted earnings per-share computations:
 
 
 Three Months Ended December 31, 2016 
 
 Net Income – Restated(1)
 Weighted Average Shares 
 EPS 
Basic earnings per share
 3,521,153 
  5,994,431 
 0.59 
Gain on derivatives(2)
  (1,556,754)
  90,277 
    
 
    
    
    
Dilutive earnings per share
 1,964,399 
  6,084,708 
 0.32 
 (1) See Note I - Restatement
    
    
 (2) Includes certain Series CC, DD, EE and FF warrants
    
    
 
 
 Three Months Ended December 31, 2015 
 
 Net Income – Restated(1)
 Weighted Average Shares 
 EPS 
Basic earnings per share
 2,332,734 
  4,390,740 
 0.53 
Conversion of note payable
  24,841 
  74,851 
    
 
    
    
    
Dilutive earnings per share
 2,357,575 
  4,465,591 
 0.53 
 (1) See Note I - Restatement
    
    
    
 
The gain on derivatives priced lower than the average market price during the period is excluded from the numerator and the related shares are excluded from the denominator in calculating diluted loss per share.
 
In accordance with the contingently issuable shares guidance of FASB ASC Topic 260, Earnings Per Share, the calculation of diluted net earnings (loss) per share excludes the following securities because their inclusion would have been anti-dilutive as of December 31:
 
 
 2016 
 2015 
 
   
   
Options and Warrants
  6,946,179 
  2,991,061 
Unvested Restricted Stock
  604,000 
  604,000 
Total
  7,550,179 
  3,595,061 
 
I. 
RESTATEMENT
 
In October 2008, the Company entered into a lease arrangement whereby the Company leased a building owned by a third party, but to which the owner made tenant-directed improvements. Upon commencement of the lease, the Company accounted for the arrangement as an operating lease under ASC 840, Accounting for Leases, whereby the total minimum lease payment obligations under the leases were recognized as monthly rent expense on a straight-line basis over the term of the lease. The cost of the tenant improvements incurred were capitalized as deferred rent and amortized over the 20-year lease term.
 
However, in November 2017, the Company discovered an error in the way it accounted for the lease for the building since it was determined that, as the terms of the original lease required the Company to be responsible for possible cost overruns, (but of which there were none), the Company was deemed to be the owner of the leased building for accounting purposes only under ASC 840-40-55. In addition to the costs it incurred and capitalized for the tenant improvements, the Company should have reflected an asset on its balance sheet for the costs paid by the lessor to purchase and improve the building, as well as a corresponding liability. Upon completion of the improvements, the Company did not meet the “sale-leaseback” criteria under ASC 840-40-25, Accounting for Leases, Sale-Leaseback Transactions due to the Company’s significant continuing involvement with the facility which is considered to be other than a normal leaseback as defined in ASC 840-40-25 and therefore should have treated the lease as a financing obligation and the asset and corresponding liability should not be derecognized.
 
 
20
 
 
The corrections to the historical financial statements to apply ASC 840-40-25 do not affect the total cash payments the Company has made or is obligated to make under the lease agreement, nor does it change the total expense to be recognized over the lease term. However, the timing and nature of expense is different under this treatment as compared to operating lease treatment. Specifically, the Company should have recognized depreciation, expense on the building it is deemed to own and interest expense on the associated lease financing obligation, instead of rental expense.
 
The accompanying financial statements for three months ended December 31, 2016 have been restated to reflect the correction of the error for the lease accounting. Accumulated deficit at September 30, 2016, was reduced by $276,855. The following is a summary of the restatements:
 
 
 December 31, 2016 
Balance Sheet
 PREVIOUSLY REPORTED 
 ADJUSTMENT 
 RESTATED 
Total current assets
 $4,522,290 
 $(415,003)
 $4,107,287 
Other assets
  5,405,599 
  13,738,445 
  19,144,044 
Total assets
  9,927,889 
  13,323,442 
  23,251,331 
Total liabilities
  5,494,598 
  13,062,236 
  18,556,834 
Stockholders' equity
  4,433,291 
  261,206 
  4,694,497 
 
 
 September 30, 2016 
Balance Sheet
 PREVIOUSLY REPORTED 
 ADJUSTMENT 
 RESTATED 
Total current assets
 $5,887,646 
 $(429,821)
 $5,457,825 
Other assets
  5,710,601 
  13,717,699 
  19,428,300 
Total assets
  11,598,247 
  13,287,878 
  24,886,125 
Total liabilities
  12,554,315 
  13,011,023 
  25,565,338 
Stockholders' deficit
  (956,068)
  276,855 
  (679,213)
 
 
 Three Months Ended December 31, 2016 
Statement of Operations
 PREVIOUSLY REPORTED 
 ADJUSTMENT 
 RESTATED 
Research and development expenses
 $4,024,856 
 $(476,599)
 $3,548,257 
Total operating expenses
  5,431,865 
  (476,599)
  4,955,266 
Operating loss
  (5,414,607)
  476,599 
  (4,938,008)
Interest income (expense), net
  23,097 
  (492,248)
  (469,151)
Net income
  3,536,802 
  (15,649)
  3,521,153 
 
    
    
    
Net income per share - basic
 $0.59 
    
 $0.59 
Net income per share - diluted
 $0.33 
    
 $0.32 
 
 
 Three Months Ended December 31, 2015 
Statement of Operation
 PREVIOUSLY REPORTED 
 ADJUSTMENT 
 RESTATED 
Research and development expenses
 $5,169,507 
 $(476,599)
 $4,692,908 
Total operating expenses
  5,804,108 
  (476,599)
  5,327,509 
Operating loss
  (5,783,132)
  476,599 
  (5,306,533)
Interest income (expense), net
 1,985
  (485,678)
  (483,693)
Net income
  2,341,813 
  (9,079)
  2,332,734 
 
    
    
    
Net income per share - basic and diluted
 $0.53 
    
 $0.53 
 
 
 Accumulated Deficit 
PREVIOUSLY REPORTED, SEPTEMBER 30, 2016
 $(285,667,977)
ADJUSTMENT
  276,855 
RESTATED BALANCE, SEPTEMBER 30, 2016
  (285,391,122)
 
    
Net income - RESTATED
  3,521,153 
BALANCE, DECEMBER 31, 2016
 $(281,869,969)

J.
SUBSEQUENT EVENTS
 
The Company has evaluated subsequent events through the date these financial statements were filed and determined there are no subsequent events that require disclosure.
 
 
21
 
 
Item 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
 
Correction of an Error
 
The historical financial information in this report have been restated. In November 2017, the Company discovered an error in the way it accounted for the operating lease for its manufacturing facility. In October 2008, the Company entered into a lease arrangement whereby the Company leased a building owned by a third party, but to which the owner made tenant-directed improvements. Upon commencement of the lease, the Company accounted for the arrangement as an operating lease under ASC 840, Accounting forLeases, whereby the total minimum lease payment obligations under the leases were recognized as monthly rent expense on a straight-line basis over the term of the lease. The cost of the tenant improvements incurred were capitalized as deferred rent and amortized over the 20-year lease term.
 
In November 2017, it was determined that because the terms of the original lease agreement required the Company to be responsible for possible cost overruns, if there were any, but of which there were none, the Company was deemed to be the owner of the leased building for accounting purposes only under ASC 840-40-55. In addition to the costs it incurred and capitalized for the tenant improvements, the Company should have reflected an asset on its balance sheet for the costs paid by the lessor to purchase the building and improve it, as well as a corresponding liability. Upon completion of the improvements, the Company did not meet the “sale-leaseback” criteria under ASC 840-40-25, Accounting for Leases, Sale-Leaseback Transactions due to the Company’s significant continuing involvement with the facility which is considered to be other than a normal leaseback as defined in ASC 840-40-25 and therefore should have treated the lease as a financing obligation and the asset and corresponding liability should not be derecognized.
 
The correction to the historical financial statements to apply ASC 840-40-25 does not affect the total cash payments the Company has made or is obligated to make under the lease agreement, nor does it change the total expense to be recognized over the lease term. However, the timing and nature of expense is different under this treatment as compared to operating lease treatment. Specifically, the Company should have recognized depreciation, expense on the asset it is deemed to own and interest expense on the associated lease financing obligation, instead of rental expense.
 
The accompanying Management's Discussion and Analysis of Financial Condition and Results of Operations gives effect to the restatement adjustments made to the previously reported financial statements for the three months ended December 31, 2016 and 2015. For additional information and a detailed discussion of the restatement, see Note I of the financial statements included in this Report.
 
Liquidity and Capital Resources
 
The Company’s lead investigational therapy, Multikine® (Leukocyte Interleukin, Injection), is cleared for a Phase 3 clinical trial in advanced primary head and neck cancer. Multikine has been cleared by the regulators in twenty four countries around the world, including the U.S. FDA.
 
On September 26, 2016, the Company received verbal notice from FDA that the Phase 3 clinical trial in advanced primary head and neck cancer has been placed on clinical hold. At such time, enrollment in the Phase 3 study was 926 patients. Pursuant to this communication from FDA, patients currently receiving study treatments can continue to receive treatment, and patients already enrolled in the study will continue to be followed.
 
On October 21, 2016, the Company received a partial clinical hold letter from FDA and, on November 18, 2016, the Company submitted a response to FDA’s partial clinical hold letter.
 
In its partial clinical hold letter, FDA identified the following specific deficiencies: a) FDA stated that there is an unreasonable and significant risk of illness or injury to human subjects and cited among other things the absence of prompt reports by the Company to the FDA of IDMC recommendations to close the study entirely (made in spring of 2014) or at least to close it to accrual of new patients (made in spring of 2016); b) FDA stated that the investigator brochure is misleading, erroneous, and materially incomplete; and c) FDA stated that the plan or protocol is deficient in design to meet its stated objectives. In its partial clinical hold letter, FDA also identified the information needed to resolve these deficiencies. In addition, FDA’s partial clinical hold letter included two requests relating to quality information regarding the Company’s investigational final drug product, which were noted by FDA as non-hold issues. The Company believes that its response submitted to FDA on November 18, 2016, addressed each of the deficiencies identified by FDA including detailing its belief that, under the applicable FDA guidance, there was no obligation to report the cited IDMC recommendations to the FDA at the time they were issued, and it also requested a face-to-face meeting with FDA, and outlined the Company’s commitment to diligently work with FDA in an effort to have the partial clinical hold for the study lifted.
 
On December 8, 2016, FDA advised us that the Agency was denying the Company’s request for a meeting at that time because FDA’s review of the Company’s November 18, 2016 response was ongoing. The Company also was advised that the Company would be receiving a letter addressing its November 18, 2016 response by December 18, 2016.
 
 
22
 
 
On December 16, 2016, FDA issued an Incomplete Response To Hold letter to the Company indicating that based on the Agency’s preliminary review of the Company’s November 18, 2016 submission, FDA has determined that it is not a complete response to all of the issues listed in FDA’s clinical hold letter. FDA identified the following specific deficiencies: a) FDA stated that the Company did not provide the information identified as necessary to address FDA’s statement that patients enrolled in the study are exposed to unreasonable and significant risk of illness or injury to human subjects; b) FDA stated that the Company did not provide the information identified as necessary to address FDA’s statement that continued enrollment of patients in the study exposes the patients to unreasonable risks and FDA furthermore stated that the study is unlikely to demonstrate that the addition of the Company’s investigational drug Multikine to the standard of care is superior to standard of care and thus should be terminated for futility; (c) FDA stated that the Company did not provide the information identified as necessary to address FDA’s statement that the investigator brochure is misleading, erroneous, and materially incomplete; (d) FDA stated that the Company did not provide the information identified as necessary to address FDA’s statement that the proposed revised clinical protocol is inadequate in design to meet its stated objectives and FDA furthermore stated that this deficiency cannot be addressed by further revisions to the protocol. In its incomplete response to hold letter, FDA also identified the steps the Company must take to address these deficiencies. In addition, FDA’s incomplete response to hold letter noted with respect to FDA’s two requests relating to quality information regarding the Company’s investigational final drug product, which the Company had been instructed by FDA to submit separately from the response to the partial clinical hold, which again were noted by FDA as non-hold issues, that the Company’s November 18, 2016, submission had not included the information addressing these two requests.
 
The Company is reviewing all of its options in response to FDA’s incomplete response to hold letter. As an initial matter, the Company plans to send FDA a request accompanied by the required complete meeting package for an in person meeting with the Agency to discuss all matters relating to the partial clinical hold, because, among other things, the Company believes that there may be some misunderstanding regarding its conduct of the Phase 3 clinical trial as well as some misinterpretation of some of the information contained in the response the Company submitted on November 18, 2016 to the partial clinical hold letter. Pending the scheduling of that FDA meeting and resolution of the partial clinical hold issues, the Company expects to prepare a comprehensive submission to FDA detailing its belief, accompanied by what the Company believes to be appropriate supporting data, records, and information reflecting that the Company has taken the steps necessary to address the specific deficiencies identified by FDA, including: a) demonstrating that patients enrolled in the study are not exposed to unreasonable and significant risk of illness or injury; b) demonstrating that continued enrollment of patients in the study does not expose the patients to unreasonable risks and that the study should not be terminated for futility; (c) demonstrating that a supplemented investigator brochure is not misleading, erroneous, or materially incomplete; (d) demonstrating that the proposed revised clinical protocol is adequate in design to meet its stated objectives and that this deficiency can be addressed by the proposed revisions to the protocol.
 
Subject to the partial clinical hold, the Company’s estimate that the total remaining cash cost of the Phase 3 clinical trial, excluding any costs that will be paid by our partners, would be approximately $13.5 million. Should FDA lift the partial clinical hold and allow the amended protocol submitted to them to proceed, which requires an enrollment of up to 1,273 subjects, the remaining cost of the Phase 3 clinical trial will be higher than currently estimated. This is in addition to the approximately $36.0 million that the Company already had spent on the trial as of December 31, 2016. This number may be affected by the rate of any future patient enrollment, rate of death accumulation in the study, foreign currency exchange rates, and many other factors, some of which cannot be foreseen today. It is therefore possible that the cost of the Phase 3 clinical trial will be higher than currently estimated. If FDA will only lift the partial clinical hold with termination of the current study and initiation of a new clinical trial, any such new trial can only be initiated if permitted by FDA and as appropriate other regulatory authorities around the world after the requisite submissions are made to them, and the additional duration and costs of the Phase 3 clinical program would likely exceed those already incurred in connection with the Phase 3 clinical trial. If there is a need to conduct an additional Phase 3 pivotal study, any such requirement would have significant and severe material consequences for us and could impact our ability to continue as a going concern.
 
 
23
 
 
The Company will not be able to enroll any additional patients in the Phase 3 study unless FDA lifts the partial clinical hold. In addition, in the spring of 2016, the IDMC recommended to us that new patient enrollment should stop in the Phase 3 study, but patients already on study should continue to be treated and followed. Although the Company had expected to work through the concerns raised by the IDMC while the Company worked through the partial clinical hold with FDA, the IDMC informed us on December 13, 2016, that because the study is on partial clinical hold imposed by FDA, the IDMC has no formal recommendation regarding continuation of the trial at this time. If the partial clinical hold is not lifted by FDA or if it is determined by FDA that the study has been compromised, the study may be terminated, or if the partial clinical hold is lifted by FDA but the IDMC continues to recommend that enrollment not be allowed to continue, the study may be terminated by the Company.
 
If the partial clinical hold is not lifted, the Phase 3 study will not be able to be completed to its prespecified endpoints in a timely manner, if at all, and, if the Phase 3 study cannot be completed to its prespecified endpoints, the study would not be able to be used as the pivotal study supporting a marketing application in the United States, and at least one entirely new Phase 3 pivotal study would need to be conducted to provide the pivotal study supporting a marketing application in the United States. Even if the partial clinical hold is lifted, if it is not lifted in a timely fashion, the nature and duration of the partial clinical hold could irreparably harm the data from the Phase 3 study such that it may no longer be able to be used as the pivotal study supporting a marketing application in the United States. Even if the partial clinical hold is lifted in a timely fashion, it remains possible that the regulatory authorities could determine that the Phase 3 study is not sufficient to be used as a single pivotal study supporting a marketing application in the United States.
 
Multikine is also being used in a Phase I study at UCSF in HIV/HPV co-infected men and women with peri-anal warts.
 
Multikine (Leukocyte Interleukin, Injection) is the full name of this investigational therapy, which, for simplicity, is referred to in the remainder of this report 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.
 
The Company also owns and is developing a pre-clinical technology called LEAPS (Ligand Epitope Antigen Presentation System).
 
All of the Company’s projects are under development. As a result, the Company cannot predict when it will be able to generate any revenue from the sale of any of its products.
 
Since inception, the Company has financed its operations through the sale of equity securities, convertible notes, loans and certain research grants. The Company’s expenses will continue to exceed its revenues as it continues the development of Multikine and brings other drug candidates into clinical trials. Until such time as the Company becomes profitable, any or all of these financing vehicles or others may be utilized to assist the Company’s capital requirements.
 
 
24
 
 
Capital raised by the Company has been expended primarily for patent applications, research and development, administrative costs, and the construction of the Company’s laboratory facilities. The Company does not anticipate realizing significant revenues until it enters into licensing arrangements regarding its technology and know-how or until it receives regulatory approval to sell its products (which could take a number of years). As a result the Company has been dependent upon the proceeds from the sale of its securities to meet all of its liquidity and capital requirements and anticipates having to do so in the future.
 
The Company will be required to raise additional capital or find additional long-term financing in order to continue with its research efforts. The ability to raise capital may be dependent upon market conditions that are outside the control of the Company. Additionally, the partial clinical hold may also impact the Company’s ability to attract new capital. The ability of the Company to complete the necessary clinical trials and obtain FDA approval for the sale of products to be developed on a commercial basis is uncertain. Ultimately, the Company must complete the development of its products, obtain the appropriate regulatory approvals and obtain sufficient revenues to support its cost structure. The Company is taking cost-cutting initiatives, as well as exploring other sources of funding to finance operations over the next 12 months. However there can be no assurance that the Company will be able to raise sufficient capital to support its operations.
 
The Company estimates the total remaining cash cost of the Phase 3 trial, with the exception of the parts that will be paid by its licensees, Teva Pharmaceuticals and Orient Europharma, to be approximately $13.5 million. This is in addition to approximately $36 million which has been paid as of December 31, 2016. It should be noted that this estimate is based only on the information currently available in the Company’s contracts with the Clinical Research Organizations responsible for managing the Phase 3 clinical trial and does not include other related costs, e.g. the manufacturing of the drug. This number can be affected by the speed of enrollment, rate of death of patients, foreign currency exchange rates and many other factors, some of which cannot be foreseen today.  It is therefore possible that the cost of the Phase 3 trial will be higher than currently estimated.
 
In April 2013, the Company announced that it had replaced the CRO running its Phase 3 clinical trial. This was necessary since the patient enrollment in the study dropped off substantially following a takeover of the CRO which caused most of the members of the CRO’s study team to leave the CRO. The Company announced that it had hired two CRO’s who will manage the global Phase 3 study; ICON and Ergomed, who are both international leaders in managing oncology trials. Both CRO’s helped the Company expand the trial to over 80 clinical sites globally. As of December 31, 2016, the study has enrolled 926 patients.
 
Under a co-development agreement, Ergomed will contribute up to $12 million towards the study where it will perform clinical services in exchange for a single digit percentage of milestone and royalty payments, up to a specified maximum amount, only from sales for head and neck cancer. Ergomed, a privately-held firm headquartered in Europe with global operations, has entered into numerous similar co-development agreements, including one with Genzyme (purchased by Sanofi in 2011 for over $20 billion). Ergomed will be responsible for the new patient enrollment.
 
 
25
 
 
During the three months ended December 31, 2016, the Company’s cash decreased by approximately $531,000.  Significant components of this decrease include net proceeds from the sale of the Company’s stock of approximately $3.7 million offset by net cash used to fund the Company’s regular operations, including its Phase 3 clinical trial, of approximately $4.2 million and payments on capital leases of approximately $2,000. During the three months ended December 31, 2015, the Company’s cash increased by approximately $4.7 million.  Significant components of this increase include net proceeds from the sale of the Company’s stock of approximately $10.6 million offset by net cash used to fund the Company’s regular operations, including its Phase 3 clinical trial, of approximately $5.8 million, purchases of equipment of approximately $15,000 and payments on capital leases of approximately $2,000.
 
On December 8, 2016, the Company sold 1,360,960 shares of common stock and warrants to purchase common stock at a price of $3.13 in a public offering. The warrants consist of 680,480 Series CC warrants to purchase 680,480 shares of common stock, 1,360,960 Series DD warrants to purchase 1,360,960 shares of common stock and 1,360,960 Series EE warrants to purchase 1,360,960 shares of common stock. The Series CC warrants are immediately exercisable, expire in five-years and have an exercise price of $5.00 per share. The Series DD warrants are immediately exercisable, expire in six-months and have an exercise price of $4.50 per share. The Series EE warrants are immediately exercisable, expire in nine-months and have an exercise price of $4.50 per share. In addition, the Company issued 68,048 Series FF warrants to purchase 68,048 shares of common stock to the placement agent. The FF warrants are exercisable at any time on or after June 8, 2017 and expire on December 1, 2021 and have an exercise price $3.91. The net proceeds to CEL-SCI from this offering was approximately $3.7 million, excluding any future proceeds that may be received from the exercise of the warrants.  
 
Inventory decreased by approximately $314,000 at December 31, 2016 as compared to September 30, 2016, due to the timing of supplies purchased and used in the manufacturing of Multikine for the Phase 3 clinical trial. In addition, receivables decreased by approximately $390,000, primarily due to the timing of payments reimbursed under the litigation funding arrangement noted above.
 
Results of Operations and Financial Condition
 
During the three months ended December 31, 2016, research and development expenses decreased by approximately $1.1 million compared to the three months ended December 31, 2015. The Company is continuing the Phase 3 clinical trial subject to the partial clinical hold, and research and development fluctuates based on the activity level of the clinical trial.
 
During the three months ended December 31, 2016, general and administrative expenses increased by approximately $772,000 compared to the three months ended December 31, 2015. This increase is primarily due to an approximate $1.1 million gain on de-recognition of legal fees to record the transfer of the liability from the Company to Lake Whillans that existed prior to the execution of the financing agreement. The gain on de-recognition of legal fees is recorded as a reduction of general and administrative expenses in the three months ended December 31, 2015, offset by an approximate $366,000 decrease in employee and non-employee stock compensation due to the decrease in the market value of the common stock and 2,800 fewer shares issued in the three months ended December 31, 2016.
 
The gain on derivative instruments of approximately $8.9 million for the three months ended December 31, 2016 was the result of the change in fair value of the derivative liabilities during the quarter. This change was caused by decreases in the share price of the Company’s common stock.
 
 
26
 
 
Net interest expense decreased by approximately $15,000 for the three months ended December 31, 2016 compared to the three months ended December 31, 2015. Interest expense consists primarily of interest expense on the financing lease offset by interest income earned on the Company’s cash balances.
 
Research and Development Expenses
 
The Company’s research and development efforts involve Multikine and LEAPS. The table below shows the research and development expenses associated with each project.
 
 
 Three months ended December 31, 
 
 2016 
 2015 
 
   
   
MULTIKINE - Restated
 3,463,006 
 4,597,826 
LEAPS
  85,251 
  95,082 
 
    
    
TOTAL - Restated
 3,548,257 
 4,692,908 
 
Clinical and other studies necessary to obtain regulatory approval of a new drug involve significant costs and require several years to complete. The extent of the Company’s clinical trials and research programs are primarily based upon the amount of capital available to the Company and the extent to which the Company has received regulatory approvals for clinical trials. The inability of the Company to conduct clinical trials or research, whether due to a lack of capital or regulatory approval, will prevent the Company from completing the studies and research required to obtain regulatory approval for any products which the Company is developing. Without regulatory approval, the Company will be unable to sell any of its products. Since all of the Company’s projects are under development, the Company cannot predict when it will be able to generate any revenue from the sale of any of its products.
 
Critical Accounting Estimates and Policies
 
Management’s discussion and analysis of the Company’s financial condition and results of operations is based on its unaudited condensed financial statements. The preparation of these financial statements is based on the selection of accounting policies and the application of significant accounting estimates, some of which require management to make judgments, estimates and assumptions that affect the amounts reported in the financial statements and notes. The Company believes some of the more critical estimates and policies that affect its financial condition and results of operations are in the areas of operating leases and stock-based compensation. For more information regarding the Company’s critical accounting estimates and policies, see Part II, Item 7 of the Company’s Annual Report on Form 10-K for the year ended September 30, 2016. The application of these critical accounting policies and estimates has been discussed with the Audit Committee of the Company’s Board of Directors.
 
 
27
 
 
Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS
 
The Company does not believe that it has any significant exposures to market risk.
 
Item 4.
CONTROLS AND PROCEDURES
 
Evaluation of Disclosure Controls and Procedures
 
Under the direction and with the participation of the Company’s management, including the Company’s Chief Executive and Chief Financial Officer, the Company has conducted an evaluation of the effectiveness of the design and operation of its disclosure controls and procedures as of December 31, 2016. The Company maintains disclosure controls and procedures that are designed to ensure that information required to be disclosed in its periodic reports with the Securities and Exchange Commission is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and regulations, and that such information is accumulated and communicated to the Company’s management, including its principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure. The Company’s disclosure controls and procedures are designed to provide a reasonable level of assurance of reaching its desired disclosure control objectives. As explained in Note I to the accompanying financial statements which are part of this report, in November 2017, the Company discovered an error in the way it accounted for the lease for its manufacturing facility. Management has concluded that the correction of the error for this lease, the lack of impairment assessment for the related asset, and the operating effectiveness of the financial close process are control deficiencies that constitute material weaknesses. Based on the above, the Company’s Chief Executive and Financial Officer concluded that the Company’s disclosure controls and procedures were not effective as of December 31, 2016.
 
Changes in Internal Control over Financial Reporting
 
The Company’s management, with the participation of the Chief Executive and Chief Financial Officer, has evaluated whether any change in the Company’s internal control over financial reporting occurred during the first three months of fiscal year 2017. There was no change in the Company’s internal control over financial reporting during the three months ended December 31, 2016.
 
 
28
 
 
PART II
 
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds.
 
During the three months ended December 31, 2016 the Company issued 10,800 restricted shares of common stock to consultants for investor relations services.
 
The Company relied upon the exemption provided by Section 4(a)(2) of the Securities Act of 1933 with respect to the issuance of these shares. The individuals who acquired these shares were sophisticated investors and were provided full information regarding our business and operations. There was no general solicitation in connection with the offer or sale of these securities. The individuals who acquired these shares acquired them for their own accounts. The certificate representing these shares bears a restricted legend providing that they cannot be sold except pursuant to an effective registration statement or an exemption from registration. No commission or other form of remuneration was given to any person in connection with the issuance of these shares.
 
 
Item 6. (a) Exhibits
 
Number              
Exhibit
 
Rule 13a-14(a) Certifications
 
Section 1350 Certifications
 
 
29
 
 
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.
 
 
 
CEL-SCI CORPORATION
 
 
 
 
 
Date: December 11, 2017
By:  
/s/  Geert Kersten
 
 
 
Geert Kersten 
 
 
 
Principal Executive Officer* 
 
 
 
 
 
 
 
* Also signing in the capacity of the Principal Accounting and Financial Officer.
 
 

 
30
EX-31 2 cvm_ex31.htm CERTIFICATION PURSUANT TO RULE 13A-14(A)/15D-14(A) CERTIFICATIONS SECTION 302 OF THE SARBANES-OXLY ACT OF 2002 Blueprint
 
EXHIBIT 31
 
 
CERTIFICATIONS
I, Geert Kersten, certify that:
1.            
I have reviewed this quarterly report on Form 10-Q/A of CEL-SCI Corporation;
2.            
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.            
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.            
The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15 and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a)           designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b)           designed such internal control over financial reporting, or cause such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c)           evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d)           disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.            
The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of the internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
a)           all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b)           any fraud, whether or not material, that involves management or other employees who have significant role in the registrant’s internal control over financial reporting.
 
 
 
 
 
 
December 11, 2017     
By:  
/s/  Geert Kersten
 
 
 
Geert Kersten 
 
 
 
Principal Executive Officer
 
 
 
 
 
CERTIFICATIONS
 
I, Geert Kersten, certify that:
1.            
I have reviewed this quarterly report on Form 10-Q/A of CEL-SCI Corporation;
2.            
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.            
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.            
The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15 and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a)           designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b)           designed such internal control over financial reporting, or cause such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c)           evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d)           disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.            
The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of the internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
a)           all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b)           any fraud, whether or not material, that involves management or other employees who have significant role in the registrant’s internal control over financial reporting.
 
 
 
 
 
 
December 11, 2017     
By:  
/s/  Geert Kersten
 
 
 
Geert Kersten 
 
 
 
Principal Financial Officer
 
 
 
 
EX-32 3 cvm_ex32.htm CERTIFICATE PURSUANT TO SECTION 18 U.S.C. PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 Blueprint
 
EXHIBIT 32
 
 
In connection with the Quarterly Report of CEL-SCI Corporation (the “Company”) on Form 10-Q/A for the period ending December 31, 2016 as filed with the Securities and Exchange Commission (the “Report”), Geert Kersten, the Principal Executive and Financial Officer of the Company, certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of his knowledge:
 
(1)
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
 
(2)
The information contained in the Report fairly presents, in all material respects, the financial condition and results of the Company.
 
 
 
 
 
 
 
December 11, 2017     
By:  
/s/  Geert Kersten
 
 
 
Geert Kersten 
 
 
 
Principal Executive and
Principal Financial Officer 
 
 
 

 
 
 
 
 
 
 
 
 
 
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padding-right: 5.4pt; padding-left: 5.4pt; text-align: right"><font style="font: 8pt Times New Roman, Times, Serif">$&#9;183,000</font></td></tr> <tr style="vertical-align: top"> <td style="padding-right: 5.4pt; padding-left: 5.4pt"><font style="font: 8pt Times New Roman, Times, Serif">Year ending September 30,</font></td> <td style="padding-right: 5.4pt; padding-left: 5.4pt; text-align: right">&#160;</td></tr> <tr style="vertical-align: top"> <td style="padding-right: 5.4pt; padding-left: 5.4pt"><font style="font: 8pt Times New Roman, Times, Serif">2018</font></td> <td style="padding-right: 5.4pt; padding-left: 5.4pt; text-align: right"><font style="font: 8pt Times New Roman, Times, Serif">251,000</font></td></tr> <tr style="vertical-align: top"> <td style="padding-right: 5.4pt; padding-left: 5.4pt"><font style="font: 8pt Times New Roman, Times, Serif">2019</font></td> <td style="padding-right: 5.4pt; padding-left: 5.4pt; text-align: right"><font style="font: 8pt Times New Roman, Times, Serif">258,000</font></td></tr> <tr style="vertical-align: top"> <td style="padding-right: 5.4pt; padding-left: 5.4pt"><font style="font: 8pt Times New Roman, Times, Serif">2020</font></td> <td style="padding-right: 5.4pt; padding-left: 5.4pt; text-align: right"><font style="font: 8pt Times New Roman, Times, Serif">238,000</font></td></tr> <tr style="vertical-align: top"> <td style="padding-right: 5.4pt; padding-left: 5.4pt"><font style="font: 8pt Times New Roman, Times, Serif">2021</font></td> <td style="padding-right: 5.4pt; padding-left: 5.4pt; text-align: right"><font style="font: 8pt Times New Roman, Times, Serif">163,000</font></td></tr> <tr style="vertical-align: top"> <td style="padding-right: 5.4pt; padding-left: 5.4pt"><font style="font: 8pt Times New Roman, Times, Serif">2022</font></td> <td style="border-bottom: Black 1pt solid; padding-right: 5.4pt; padding-left: 5.4pt; text-align: right"><font style="font: 8pt Times New Roman, Times, Serif">69,000</font></td></tr> <tr style="vertical-align: top"> <td style="padding-right: 5.4pt; padding-left: 5.4pt; font-family: Arial, Helvetica, Sans-Serif; letter-spacing: -0.1pt"><font style="font: 8pt Times New Roman, Times, Serif">Total</font></td> <td style="border-bottom: Black 1.5pt double; padding-right: 5.4pt; padding-left: 5.4pt; text-align: right"><font style="font: 8pt Times New Roman, Times, Serif; text-underline-style: double"><u>$&#9;1,162,000</u></font></td></tr> </table> 183000 251000 258000 238000 163000 69000 1162000 1269000 1747000 1808000 1872000 1937000 2004000 13758000 24395000 -11333000 13062000 EX-101.SCH 5 cvm-20161231.xsd XBRL TAXONOMY EXTENSION SCHEMA 00000001 - Document - Document and Entity Information link:presentationLink link:calculationLink link:definitionLink 00000002 - Statement - BALANCE SHEETS link:presentationLink link:calculationLink link:definitionLink 00000003 - Statement - BALANCE SHEETS (Parenthetical) link:presentationLink link:calculationLink link:definitionLink 00000004 - Statement - STATEMENTS OF OPERATIONS link:presentationLink link:calculationLink link:definitionLink 00000005 - Statement - STATEMENTS OF CASH FLOWS link:presentationLink link:calculationLink link:definitionLink 00000006 - Disclosure - A. 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Document and Entity Information - shares
3 Months Ended
Dec. 31, 2016
Feb. 03, 2017
Document And Entity Information    
Entity Registrant Name CEL SCI CORP  
Entity Central Index Key 0000725363  
Document Type 10-Q/A  
Document Period End Date Dec. 31, 2016  
Amendment Flag true  
Amendment Description

In October 2008, the Company entered into an agreement whereby the Company leased a building owned by a third party. The Company accounted for the arrangement as an operating lease under ASC 840, Accounting for Leases.

 

In November 2017, the Company determined that the lease should have been treated as a financing obligation rather than an operating lease.

 

Accordingly, this amended 10-Q is filed to correct the manner in which the Company accounted for the lease. See Note I. Restatement, to the accompanying financial statements, for further information.

 

In addition, per share data, including earnings per share amounts, in this amended 10-Q have been adjusted to reflect a 1 for 25 reverse stock split which became effective on the NYSE American on June 15, 2017.

 

As a result of the error described above, management has concluded that the Company’s internal control over financial reporting and its disclosure controls and procedures were not effective as of the end of this reporting period. The effects of the material weaknesses are discussed in more detail in Item 4, Controls and Procedures.

 
Current Fiscal Year End Date --09-30  
Is Entity a Well-known Seasoned Issuer? No  
Is Entity a Voluntary Filer? No  
Is Entity's Reporting Status Current? Yes  
Entity Filer Category Accelerated Filer  
Entity Common Stock, Shares Outstanding   7,638,618
Document Fiscal Period Focus Q1  
Document Fiscal Year Focus 2017  
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BALANCE SHEETS - USD ($)
Dec. 31, 2016
Sep. 30, 2016
CURRENT ASSETS:    
Cash and cash equivalents $ 2,386,673 $ 2,917,996
Receivables 4,128 394,515
Prepaid expenses 866,987 981,677
Deposits - current portion 154,995 154,995
Inventory used for R&D and manufacturing 694,504 1,008,642
Total current assets 4,107,287 5,457,825
PROPERTY AND EQUIPMENT, net 17,225,860 17,350,836
PATENT COSTS, net 247,267 256,547
DEPOSITS 1,670,917 1,820,917
TOTAL ASSETS 23,251,331 24,886,125
CURRENT LIABILITIES:    
Accounts payable 2,741,353 3,091,512
Accrued expenses 319,476 378,672
Due to employees 476,413 538,278
Derivative instruments, current portion 249,157 0
Other current liabilities 7,203 3,310
Total current liabilities 3,793,602 4,011,772
Derivative instruments - net of current portion 1,533,549 8,394,934
Lease liability 13,062,236 13,011,023
Deferred revenue 125,000 125,000
Other Liabilities 42,447 22,609
Total liabilities 18,556,834 25,565,338
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY (DEFICIT)    
Preferred stock, $.01 par value-200,000 shares authorized; -0- shares issued and outstanding 0 0
Common stock, $.01 par value - 600,000,000 shares authorized, 7,633,803 and 6,235,035 shares issued and outstanding at December 31, 2016 and September 30, 2016, respectively 76,338 62,350
Additional paid-in capital 286,488,128 284,649,559
Accumulated deficit (281,869,969) (285,391,122)
Total stockholders' equity (deficit) 4,694,497 (679,213)
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) $ 23,251,331 $ 24,886,125
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BALANCE SHEETS (Parenthetical) - $ / shares
Dec. 31, 2016
Sep. 30, 2016
Stockholders Equity    
Preferred Stock Shares Par Value $ .01 $ .01
Preferred Stock Shares Authorized 200,000 200,000
Preferred Stock Shares Issued 0 0
Preferred Stock Shares Outstanding 0 0
Common Stock Shares Par Value $ .01 $ .01
Common Stock Shares Authorized 600,000,000 600,000,000
Common Stock Shares Issued 7,633,803 6,235,035
Common Stock Shares Outstanding 7,633,803 6,235,035
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STATEMENTS OF OPERATIONS - USD ($)
3 Months Ended
Dec. 31, 2016
Dec. 31, 2015
Income Statement [Abstract]    
GRANT INCOME AND OTHER $ 17,258 $ 20,976
OPERATING EXPENSES:    
Research and development 3,548,257 4,692,908
General & administrative 1,407,009 634,601
Total operating expenses 4,955,266 5,327,509
OPERATING LOSS (4,938,008) (5,306,533)
GAIN ON DERIVATIVE INSTRUMENTS 8,928,312 8,122,960
INTEREST EXPENSE, NET (469,151) (483,693)
NET INCOME AVAILABLE TO COMMON SHAREHOLDERS $ 3,521,153 $ 2,332,734
NET INCOME PER COMMON SHARE    
BASIC $ 0.59 $ 0.53
DILUTED $ 0.32 $ 0.53
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING    
BASIC 5,994,431 4,390,740
DILUTED 6,084,708 4,465,591
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STATEMENTS OF CASH FLOWS - USD ($)
3 Months Ended
Dec. 31, 2016
Dec. 31, 2015
CASH FLOWS FROM OPERATING ACTIVITIES:    
Net income $ 3,521,153 $ 2,332,734
Adjustments to reconcile net income to net cash used in operating activities:    
Depreciation and amortization 159,173 170,177
Issuance of common stock and options for services 78,553 329,195
Equity based compensation 312,375 427,910
Common stock contributed to 401(k) plan 38,372 40,995
Loss on retired equipment 1,187 115
Gain on derivative instruments (8,928,312) (8,122,960)
Capitalized lease interest 51,213 57,468
(Increase)/decrease in assets:    
Receivables 85,046 75,206
Prepaid expenses 96,507 51,628
Inventory used for R&D and manufacturing 314,138 58,798
Deposits 150,000 150,000
Increase/(decrease) in liabilities:    
Accounts payable (75,029) (1,666,792)
Accrued expenses (59,196) 280,032
Deferred revenue 0 (1,639)
Due to employees 17,110 (25,056)
Deferred rent liability (1,496) 4,245
Net cash used in operating activities (4,239,206) (5,837,944)
CASH FLOWS FROM INVESTING ACTIVITIES:    
Purchases of equipment 0 (14,831)
Net cash used in investing activities 0 (14,831)
CASH FLOWS FROM FINANCING ACTIVITIES:    
Proceeds from issuance of common stock and warrants 3,709,931 10,550,538
Payments on obligations under capital lease (2,048) (2,194)
Net cash provided by financing activities 3,707,883 10,548,344
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS (531,323) 4,695,569
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD 2,917,996 5,726,682
CASH AND CASH EQUIVALENTS, END OF PERIOD 2,386,673 10,422,251
SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING ACTIVITIES:    
Decrease in receivable due under the litigation funding arrangement offset by the same amount payable to the legal firm providing the services 305,341 366,267
Research and office equipment included in accounts payable at year end 0 6,814
Capital lease payments included in accounts payable 372 739
Property and equipment acquired through capital lease 26,104 0
Fair value of warrants issued in connection with public offering 2,316,084 5,060,771
Financing costs included in accounts payable 77,987 21,000
Prepaid consulting services paid with issuance of common stock (18,183) 8,177
Cash paid for interest expense $ 469,366 $ 504,798
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A. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
3 Months Ended
Dec. 31, 2016
Notes to Financial Statements  
A. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

 

The accompanying condensed financial statements of CEL-SCI Corporation (the Company) are unaudited and certain information and footnote disclosures normally included in the annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been omitted pursuant to the rules and regulations of the Securities and Exchange Commission. While management of the Company believes that the disclosures presented are adequate to make the information presented not misleading, these interim condensed financial statements should be read in conjunction with the financial statements and notes included in the Company’s annual report on Form 10-K for the year ended September 30, 2016.

 

In the opinion of management, the accompanying unaudited condensed financial statements contain all accruals and adjustments (each of which is of a normal recurring nature) necessary for a fair presentation of the Company’s financial position as of December 31, 2016 and the results of its operations for the three months then ended. The condensed balance sheet as of September 30, 2016 is derived from the September 30, 2016 audited financial statements. Significant accounting policies have been consistently applied in the interim financial statements and the annual financial statements. The results of operations for the three months ended December 31, 2016 and 2015 are not necessarily indicative of the results to be expected for the entire year.

 

The financial statements have been prepared assuming that the Company will continue as a going concern, but due to recurring losses from operations and future liquidity needs, there is substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. Refer to discussion in Note B.

 

Summary of Significant Accounting Policies:

 

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.

 

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 its disposition, is less than the carrying value of the asset. The amount of the impairment loss would be the difference between the estimated fair value of the asset and its carrying value.

 

Research and Development Costs - Research and development costs are expensed as incurred.

 

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.  A full valuation allowance was recorded against the deferred tax assets as of December 31, 2016 and September 30, 2016.

 

Derivative Instruments – The Company has entered into financing arrangements that consist of freestanding derivative instruments that contain embedded derivative features. The Company accounts for these arrangements in accordance with Accounting Standards Codification (ASC) 815, “Accounting for Derivative Instruments and Hedging Activities.” In accordance with accounting principles generally accepted in the United States (U.S. GAAP), derivative instruments and hybrid instruments are recognized as either assets or liabilities in the 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. The Company determines 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. The derivative liabilities are re-measured at fair value at the end of each interim period as long as they are outstanding.

 

Deferred Rent– Certain of the Company’s operating leases provide for minimum annual payments that adjust over the life of the lease.  The aggregate minimum annual payments are expensed on a straight-line basis over the minimum lease term. The Company recognizes a deferred rent liability for rent escalations when the amount of straight-line rent exceeds the lease payments, and reduces the deferred rent liability when the lease payments exceed the straight-line rent expense.  For tenant improvement allowances and rent holidays, the Company records a deferred rent liability and amortizes the deferred rent over the lease term as a reduction to rent expense.

 

Leases – Leases are categorized as either operating or capital leases at inception. Operating lease costs are recognized on a straight-line basis over the term of the lease. An asset and a corresponding liability for the capital lease obligation are established for the cost of capital leases. The capital lease obligation is amortized over the life of the lease. For build-to-suit leases, the Company establishes an asset and liability for the estimated construction costs incurred to the extent that it is involved in the construction of structural improvements or takes construction risk prior to the commencement of the lease. Upon occupancy of facilities under build-to-suit leases, the Company assesses whether these arrangements qualify for sales recognition under the sale-leaseback accounting guidance. If a lease does not meet the criteria to qualify for a sale-leaseback transaction, the established asset and liability remain on the Company's balance sheet.

 

Stock-Based Compensation – Compensation cost for all stock-based awards is measured at fair value as of the grant date in accordance with the provisions of ASC 718 “Compensation – Stock Compensation.” The fair value of stock options is calculated using the Black-Scholes option pricing model. The Black-Scholes model requires various judgmental assumptions including volatility and expected option life. The stock-based compensation cost is recognized on the straight line allocation method as expense over the requisite service or vesting period.

 

Equity instruments issued to non-employees are accounted for in accordance with ASC 505-50, “Equity-Based Payments to Non Employees.” Accordingly, compensation is recognized when goods or services are received and is measured using the Black-Scholes valuation model. The Black-Scholes model requires various judgmental assumptions regarding the fair value of the equity instruments at the measurement date and the expected life of the options.

 

The Company has Incentive Stock Option Plans, Non-Qualified Stock Option Plans, a Stock Compensation Plan, Stock Bonus Plans and an Incentive Stock Bonus Plan. In some cases, these Plans are collectively referred to as the "Plans". All Plans have been approved by the stockholders.

 

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 interest rate assumption was based on the U.S. Treasury rate at date of the grant with term equal to the expected life of the option. 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. 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.

 

Vesting of restricted stock granted under the Incentive Stock Bonus Plan is subject to service, performance and market conditions and meets the classification of equity awards. These awards were measured at market value on the grant-dates for issuances where the attainment of performance criteria is likely and at fair value on the grant-dates, using a Monte Carlo simulation for issuances where the attainment of performance criteria is uncertain. The total compensation cost will be expensed over the estimated requisite service period.

 

New Accounting Pronouncements

 

In February 2016, the FASB issued ASU 2016-02, Leases, which will require most leases (with the exception of leases with terms of less than one year) to be recognized on the balance sheet as an asset and a lease liability. Leases will be classified as an operating lease or a financing lease. Operating leases are expensed using the straight-line method whereas financing leases will be treated similarly to a capital lease under the current standard. The new standard will be effective for annual and interim periods, within those fiscal years, beginning after December 15, 2018, but early adoption is permitted. The new standard must be presented using the modified retrospective method beginning with the earliest comparative period presented. The Company is currently evaluating the effect of the new standard on its financial statements and related disclosures.

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B. OPERATIONS AND FINANCING
3 Months Ended
Dec. 31, 2016
Notes to Financial Statements  
B. OPERATIONS AND FINANCING

The Company has incurred significant costs since its inception in connection with the acquisition of certain patented and unpatented proprietary technology and know-how relating to the human immunological defense system, patent applications, research and development, administrative costs, construction of laboratory facilities, and clinical trials.  The Company has funded such costs with proceeds from loans and the public and private sale of its common stock.  The Company will be required to raise additional capital or find additional long-term financing in order to continue with its research efforts.  Currently, the partial clinical hold has had a significant impact on the Company’s market capital, and as such, may impact the Company’s ability to attract new capital. To date, the Company has not generated any revenue from product sales.  The ability of the Company to complete the necessary clinical trials and obtain US Food & Drug Administration (FDA) approval for the sale of products to be developed on a commercial basis is uncertain. Ultimately, the Company must complete the development of its products, obtain the appropriate regulatory approvals and obtain sufficient revenues to support its cost structure.

 

The Company is currently running a large multi-national Phase 3 clinical trial for head and neck cancer with its partners TEVA Pharmaceuticals and Orient Europharma. During the three months ended December 31, 2016, the Company raised approximately $3.7 million net proceeds from a public offering. To finance the study beyond the next twelve months, the Company plans to raise additional capital in the form of corporate partnerships, debt and/or equity financings. The Company believes that it will be able to obtain additional financing because it has done so consistently in the past and because Multikine is a product in the Phase 3 clinical trial stage. However, there can be no assurance that the Company will be successful in raising additional funds on a timely basis or that the funds will be available to the Company on acceptable terms or at all.  If the Company does not raise the necessary amounts of money, it will either have to slow or delay the Phase 3 clinical trial or even significantly curtail its operations until such time as it is able to raise the required funding. The Phase 3 study is currently on partial clinical hold by the FDA. The financial statements have been prepared assuming that the Company will continue as a going concern, but due to recurring losses from operations and future liquidity needs, there is substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

Since the Company launched its Phase 3 clinical trial for Multikine, the Company has spent approximately $36.0 million as of December 31, 2016 on direct costs for the Phase 3 clinical trial.  The total remaining cash cost of the clinical trial is estimated to be approximately $13.5 million.  It should be noted that this estimate is based only on the information currently available in the Company’s contracts with the Clinical Research Organizations responsible for managing the Phase 3 clinical trial and does not include other related costs, e.g. the manufacturing of the drug.  This number can be affected by the speed of enrollment, foreign currency exchange rates and many other factors, some of which cannot be foreseen.  The Company has filed an amendment to the original Phase 3 protocol for it head and neck cancer study with the FDA to allow for this expansion in patient enrollment. Should the FDA allow the amended protocol filed with them to proceed, the remaining cost of the Phase 3 clinical trial will be higher. It is therefore possible that the cost of the Phase 3 clinical trial will be higher than currently estimated.

 

As of December 31, 2016, the Phase 3 clinical trial for Multikine was on a partial clinical hold.

 

If the partial clinical hold is not lifted, the Phase 3 study will not be able to be completed to its prespecified endpoints in a timely manner, if at all, and, if the Phase 3 study cannot be completed to its prespecified endpoints, the study would not be able to be used as the pivotal study supporting a marketing application in the United States, and at least one entirely new Phase 3 pivotal study would need to be conducted to provide the pivotal study supporting a marketing application in the United States. Even if the partial clinical hold is lifted, if it is not lifted in a timely fashion, the nature and duration of the partial clinical hold could irreparably harm the data from the Phase 3 study such that it may no longer be able to be used as the pivotal study supporting a marketing application in the United States. Even if the partial clinical hold is lifted in a timely fashion, it remains possible that the regulatory authorities could determine that the Phase 3 study is not sufficient to be used as a single pivotal study supporting a marketing application in the United States.

 

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C. STOCKHOLDERS EQUITY
3 Months Ended
Dec. 31, 2016
Notes to Financial Statements  
C. STOCKHOLDERS' EQUITY

Stock options, stock bonuses and compensation granted by the Company as of December 31, 2016 are as follows:

 

Name of Plan   Total Shares Reserved Under Plans     Shares Reserved for Outstanding Options     Shares Issued     Remaining Options/Shares Under Plans  
                         
Incentive Stock Options Plans     138,400       65,959       N/A       60,453  
Non-Qualified Stock Option Plans     387,200       262,531       N/A       95,564  
Stock Bonus Plans     223,760       N/A       160,157       63,570  
Stock Compensation Plan     134,000       N/A       83,490       49,188  
Incentive Stock Bonus Plan     640,000       N/A       624,000       16,000  

 

Stock options, stock bonuses and compensation granted by the Company as of September 30, 2016 are as follows:

 

Name of Plan   Total Shares Reserved Under Plans     Shares Reserved for Outstanding Options     Shares Issued     Remaining Options/Shares Under Plans  
                         
Incentive Stock Option Plans     138,400       65,959       N/A       60,453  
Non-Qualified Stock Option Plans     387,200       277,613       N/A       82,370  
Bonus Plans     223,760       N/A       26,448       97,278  
Stock Compensation Plan     134,000       N/A       79,401       53,276  
Incentive Stock Bonus Plan     640,000       N/A       624,000       16,000  

 

Stock option activity:

 

    Three Months Ended December 31,
    2016     2015
Granted     -       -
Expired     15,081       -
Forfeited     -       919

 

Stock-Based Compensation Expense

 

    Three months Ended December 31,
    2016     2015
Employees   $ 312,375     $ 427,910
Non-employees   $ 78,553     $ 329,195

 

Employee compensation expense includes the expense related to options issued or vested and restricted stock. Non-employee expense includes the expense related to options and stock issued to consultants expensed over the period of their service contracts.

 

Warrants and Non-employee Options

 

The following chart presents the outstanding warrants and non-employee options, listed by expiration date at December 31, 2016:

 

Warrant   Issue Date   Shares Issuable upon Exercise of Warrant     Exercise Price   Expiration Date   Reference  
                         
Series P   2/10/12     23,600     112.50   3/6/17      
Series DD   12/8/16     1,360,960     4.50   6/8/17     1  
Series EE   12/8/16     1,360,960     4.50   9/8/17     1  
Series N   8/18/08     113,785     13.18   8/18/17        
Series U   4/17/14     17,821     43.75   10/17/17     1  
Series S   10/11/13 -10/24/14     1,037,120     31.25   10/11/18     1  
Series V   5/28/15     810,127     19.75   5/28/20     1  
Series W   10/28/15     688,930     16.75   10/28/20     1  
Series X   1/13/16     120,000     9.25   1/13/21        
Series Y   2/15/16     26,000     12.00   2/15/21        
Series Z   5/23/16     264,000     13.75   11/23/21     1  
Series ZZ   5/23/16     20,000     13.75   5/18/21     1  
Series BB   8/26/16     16,000     13.75   8/22/21     1  
Series FF   12/8/16     68,048     4.00   12/1/21     1  
Series CC   12/8/16     680,480     5.00   12/8/21     1  
Series AA   8/26/16     200,000     13.75   2/22/22     1  
Consultants   3/6/12- 7/1/16     23,000     9.25- $87.50   3/5/17- 6/30/19     2  

 

1. Derivative Liabilities

 

The table below presents the warrant liabilities and their respective balances at the balance sheet dates:

 

    December 31, 2016     September 30, 2016  
Series S warrants   $ 490,040     $ 3,111,361  
Series U warrants     -       -  
Series V warrants     202,532       1,620,253  
Series W warrants     132,254       1,799,858  
Series Z warrants     101,817       970,604  
Series ZZ warrants     6,725       70,609  
Series AA warrants     84,092       763,661  
Series BB warrants     5,916       58,588  
Series CC warrants     455,931       -  
Series DD warrants     72,353       -  
Series EE warrants     176,804       -  
Series FF warrants     54,242       -  
                 
Total warrant liabilities   $ 1,782,706     $ 8,394,934  

 

The table below presents the gains on the warrant liabilities for the three months ended December 31:

 

    2016     2015  
Series S warrants   $ 2,621,321     $ 2,826,153  
Series U warrants     -       31,186  
Series V warrants     1,417,721       3,240,506  
Series W warrants     1,667,604       2,025,115  
Series Z warrants     868,787       -  
Series ZZ warrants     63,884       -  
Series AA warrants     679,569       -  
Series BB warrants     52,672       -  
Series CC warrants     604,492       -  
Series DD warrants     370,919       -  
Series EE warrants     514,603       -  
Series FF warrants     66,740       -  
                 
Net gain on warrant liabilities   $ 8,928,312     $ 8,122,960  

 

The Company reviews all outstanding warrants in accordance with the requirements of ASC 815. This topic provides that an entity should use a two-step approach to evaluate whether an equity-linked financial instrument (or embedded feature) is indexed to its own stock, including evaluating the instrument’s contingent exercise and settlement provisions. The warrant agreements provide for adjustments to the exercise price for certain dilutive events. Under the provisions of ASC 815, the warrants are not considered indexed to the Company’s stock because future equity offerings or sales of the Company’s stock are not an input to the fair value of a “fixed-for-fixed” option on equity shares, and equity classification is therefore precluded.

 

In accordance with ASC 815, derivative liabilities must be measured at fair value upon issuance and re-valued at the end of each reporting period through expiration. Any change in fair value between the respective reporting dates is recognized as a gain or loss.

 

Issuance of additional Warrants

 

On December 8, 2016, the Company sold 1,360,960 shares of common stock and warrants to purchase common stock at a price of $3.13 in a public offering. The warrants consist of 680,480 Series CC warrants to purchase 680,480 shares of common stock, 1,360,960 Series DD warrants to purchase 1,360,960 shares of common stock and 1,360,960 Series EE warrants to purchase 1,360,960 shares of common stock. The Series CC warrants are immediately exercisable, expire in five-years from the offering date and have an exercise price of $5.00 per share. The Series DD warrants are immediately exercisable, expire in six-months from the offering date and have an exercise price of $4.50 per share. The Series EE warrants are immediately exercisable, expire in nine-months from the offering date and have an exercise price of $4.50 per share. In addition, the Company issued 68,048 Series FF warrants to purchase 68,048 shares of common stock to the placement agent. The FF warrants are exercisable at any time on or after June 8, 2017 and expire on December 1, 2021 and have an exercise price $3.91. The net proceeds from this offering was approximately $3.7 million. The fair value of the Series CC, DD, EE and FF warrants of approximately $2.3 million on the date of issuance was recorded as a warrant liability.

 

Expiration of Warrants

 

On December 6, 2016, 105,000 Series R warrants, with an exercise price of $100.00, expired. The fair value of the Series R warrants was $0 on the date of expiration.

 

On December 22, 2015, 48,000 Series Q warrants, with an exercise price of $125.00, expired. The fair value of the Series Q warrants was $0 on the date of expiration.

 

2. Options and shares issued to Consultants

 

The Company typically enters into consulting arrangements in exchange for common stock or stock options. During the three months ended December 31, 2016, the Company issued 14,900 shares of common stock, of which 10,800 were restricted shares. The common stock was issued with stock prices ranging between $2.25 and $7.25 per share. During the three months ended December 31, 2015, the Company issued 17,700 shares of common stock, of which 13,600 were restricted shares. The common stock was issued with stock prices ranging between $10.25 and $18.00 per share. Additionally, during the three months ended December 31, 2015, the Company issued a consultant 6,000 options to purchase common stock at $15.00 per share and a fair value of $7.50 per share. The aggregate values of the issuances of restricted common stock and common stock options are recorded as prepaid expenses and are charged to general and administrative expenses over the periods of service.

 

During the three months ended December 31, 2016 and 2015, the Company recorded total expense of approximately $79,000 and $329,000, respectively, relating to these consulting agreements. At December 31, 2016 and September 30, 2016, approximately $30,000 and $48,000, respectively, are included in prepaid expenses. As of December 31, 2016, the Company had 23,000 options outstanding, which were issued to consultants as payment for services. Of these 23,000 outstanding options, 19,000 were vested, all of which were issued from the Non-Qualified Stock Option plans.

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D. FAIR VALUE MEASUREMENTS
3 Months Ended
Dec. 31, 2016
Fair Value Disclosures [Abstract]  
D. FAIR VALUE MEASUREMENTS

In accordance with ASC 820-10, “Fair Value Measurements,” the Company determines fair value 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 Company generally applies the income approach to determine fair value. This method uses valuation techniques to convert future amounts to a single present amount. The measurement is based on the value indicated by current market expectations with respect to those future amounts.

 

ASC 820-10 establishes a fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy gives the highest priority to active markets for identical assets and liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement). The Company classifies fair value balances based on the observability of those inputs. The three levels of the fair value hierarchy are as follows:

 

Level 1 – Observable inputs such as quoted prices in active markets for identical assets or liabilities
Level 2 – Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and amounts derived from valuation models where all significant inputs are observable in active markets
Level 3 – Unobservable inputs that reflect management’s assumptions 

  

For disclosure purposes, assets and liabilities are classified in their entirety in the fair value hierarchy level based on the lowest level of input that is significant to the overall fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment and may affect the placement within the fair value hierarchy levels.

 

The table below sets forth the assets and liabilities measured at fair value on a recurring basis, by input level, in the condensed balance sheet at December 31, 2016:

 

    Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1)     Significant Other Observable Inputs (Level 2)     Significant Unobservable Inputs (Level 3)     Total  
                         
Derivative instruments   $ 490,040     $ -     $ 1,292,666     $ 1,782,706  

 

The table below sets forth the assets and liabilities measured at fair value on a recurring basis, by input level, in the condensed balance sheet at September 30, 2016:

 

    Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1)     Significant Other Observable Inputs (Level 2)     Significant Unobservable Inputs (Level 3)     Total  
                         
Derivative instruments   $ 3,111,361     $ -     $ 5,283,573     $ 8,394,934  

 

The following sets forth the reconciliation of beginning and ending balances related to fair value measurements using significant unobservable inputs (Level 3) for the three months ended December 31, 2016 and the year ended September 30, 2016:

 

    3 Months Ended     12 Months Ended  
    December 31, 2016     September 30, 2016  
             
Beginning balance   $ 5,283,573     $ 6,323,032  
Issuances     2,316,084       8,722,073  
Realized and unrealized gains     (6,306,991 )     (9,761,532 )
Ending balance   $ 1,292,666     $ 5,283,573  

 

The fair values of the Company’s derivative instruments disclosed above under Level 3 are primarily derived from valuation models where significant inputs such as historical price and volatility of the Company’s stock, as well as U.S. Treasury Bill rates, are observable in active markets.

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E. RELATED PARTY TRANSACTIONS
3 Months Ended
Dec. 31, 2016
Notes to Financial Statements  
E. RELATED PARTY TRANSACTIONS

Effective August 31, 2016, Maximilian de Clara, the Company’s then President and a director, resigned for health reasons. In payment for past services, the Company agreed to issue Mr. de Clara 26,000 shares of restricted stock; 13,000 shares upon his resignation and 13,000 on August 31, 2017. At December 31, 2016 and September 30, 2016, the fair value accrued for unissued shares was approximately $22,000 and $101,000, respectively.

 

On January 13, 2016, the de Clara Trust demanded payment on a note payable, of which the balance, including accrued and unpaid interest, was approximately $1.1 million. The de Clara Trust was established by Maximilian de Clara, the Company’s former President and a director. The Company’s Chief Executive Officer, Geert Kersten, is the trustee and a beneficiary. When the de Clara Trust demanded payment on the note, the Company sold 120,000 shares of its common stock and 120,000 Series X warrants to the de Clara Trust for approximately $1.1 million. Each warrant allows the de Clara Trust to purchase one share of the Company's common stock at a price of $9.25 per share at any time on or before January 13, 2021.

 

During the three months ended December 31, 2016 and 2015, the Company paid approximately $0 and $33,000, respectively, in interest expense to Mr. de Clara.

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F. COMMITMENTS AND CONTINGENCIES
3 Months Ended
Dec. 31, 2016
Commitments and Contingencies Disclosure [Abstract]  
F. COMMITMENTS AND CONTINGENCIES

Clinical Research Agreements

 

In March 2013, the Company entered into an agreement with Aptiv Solutions, Inc. (which was subsequently acquired by ICON Inc.) to provide certain clinical research services in accordance with a master service agreement. The Company will reimburse ICON for costs incurred. The agreement required the Company to make $600,000 in advance payments which are being credited against future invoices in $150,000 annual increments through December 2017. As of December 31, 2016, the total balance advanced is $150,000, which is classified as a current asset.

 

In April 2013, the Company entered into a co-development and revenue sharing agreement with Ergomed. Under the agreement, Ergomed will contribute up to $10 million towards the study in the form of offering discounted clinical services in exchange for a single digit percentage of milestone and royalty payments, up to a specific maximum amount. In October 2015, the Company entered into a second co-development and revenue sharing agreement with Ergomed for an additional $2 million, for a total of $12 million. The Company accounted for the co-development and revenue sharing agreement in accordance with ASC 808 “Collaborative Arrangements”. The Company determined the payments to Ergomed are within the scope of ASC 730 “Research and Development.” Therefore, the Company records the discount on the clinical services as a credit to research and development expense on its Statements of Operations. Since the Company entered into the co-development and revenue sharing agreement with Ergomed, it has incurred research and development expenses of approximately $20.4 million related to Ergomed’s services. This amount is net of Ergomed’s discount of approximately $6.6 million. During the three months ended December 31, 2016 and 2015, the Company recorded, net of Ergomed’s discount, approximately $1.3 million and $2.0 million, respectively, as research and development expense related to Ergomed’s services.

 

In October 2013, the Company entered into two co-development and profit sharing agreements with Ergomed.  One agreement supports the Phase 1 study being conducted at the University of California, San Francisco, or UCSF, for the development of Multikine as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women.  The Phase 1 study originally started after the Company signed a cooperative research and development agreement with the U.S. Naval Medical Center, San Diego. In August 2016, the U.S. Navy discontinued this Phase 1 study because of difficulties in enrolling patients. The other agreement focuses on the development of Multikine as a potential treatment for cervical dysplasia in HIV/HPV co-infected women. Ergomed will assume up to $3 million in clinical and regulatory costs for each study.

 

The Company is currently involved in a pending arbitration proceeding, CEL-SCI Corporation v. inVentiv Health Clinical, LLC (f/k/a PharmaNet LLC) and PharmaNet GmbH (f/k/a PharmaNet AG). The Company initiated the proceedings against inVentiv Health Clinical, LLC, or inVentiv, the former third-party CRO, and are seeking payment for damages related to inVentiv’s prior involvement in the Phase 3 clinical trial of Multikine. The arbitration claim, initiated under the Commercial Rules of the American Arbitration Association, alleges (i) breach of contract, (ii) fraud in the inducement, and (iii) common law fraud. Currently, the Company is seeking at least $50 million in damages in its amended statement of claim.

 

In an amended statement of claim, the Company asserted the claims set forth above as well as an additional claim for professional malpractice.  The arbitrator subsequently granted inVentiv’s motion to dismiss the professional malpractice claim based on the “economic loss doctrine” which, under New Jersey law, is a legal doctrine that, under certain circumstances, prohibits bringing a negligence-based claim alongside a claim for breach of contract.  The arbitrator denied the remainder of inVentiv’s motion, which had sought to dismiss certain other aspects of the amended statement of claim.  In particular, the arbitrator rejected inVentiv’s argument that several aspects of the amended statement of claim were beyond the arbitrator’s jurisdiction.

 

In connection with the pending arbitration proceedings, inVentiv has asserted counterclaims against the Company for (i) breach of contract, seeking at least $2 million in damages for services allegedly performed by inVentiv; (ii) breach of contract, seeking at least $1 million in damages for the alleged use of inVentiv’s name in connection with publications and promotions in violation of the parties’ contract; (iii) opportunistic breach, restitution and unjust enrichment, seeking at least $20 million in disgorgement of alleged unjust profits allegedly made by the Company as a result of the purported breaches referenced in subsection (ii); and (iv) defamation, seeking at least $1 million in damages for allegedly defamatory statements made about inVentiv. The Company believes inVentiv’s counterclaims are meritless and intends to vigorously defend against them. However, if such defense is unsuccessful, and inVentiv successfully asserts any of its counterclaims, such an adverse determination could have a material adverse effect on the Company’s business, results, financial condition and liquidity.

 

In October 2015 the Company signed an arbitration funding agreement with a company established by Lake Whillans Litigation Finance, LLC, a firm specializing in funding litigation expenses. Pursuant to the agreement, an affiliate of Lake Whillans provides the Company with up to $5 million in funding for litigation expenses to support its arbitration claims against inVentiv. The funding is available to the Company to fund the expenses of the ongoing arbitration and will only be repaid if the Company receives proceeds from the arbitration. During the three months ended December 31, 2015, the Company recognized a gain of approximately $1.1 million on the derecognition of legal fees to record the transfer of the liability that existed prior to the execution of the financing agreement from the Company to Lake Whillans. The gain on derecognition of legal fees is recorded as a reduction of general and administration expenses on the Statement of Operations. All related legal fees are directly billed to and paid by Lake Whillans. As part of the agreement with Lake Whillans, the law firm agreed to cap its fees and expenses for the arbitration at $5 million.

 

The arbitration hearing on the merits began on September 26, 2016.

 

Lease Agreements

 

The Company leases a manufacturing facility near Baltimore, Maryland (the San Tomas lease). The building was remodeled in accordance with the Company’s specifications so that it can be used by the Company to manufacture Multikine for the Company’s Phase 3 clinical trial and sales of the drug if approved by the FDA. The lease is for a term of twenty years and requires annual base rent to escalate each year at 3%. The Company is required to pay all real estate and personal property taxes, insurance premiums, maintenance expenses, repair costs and utilities. The lease allows the Company, at its election, to extend the lease for two ten-year periods or to purchase the building at the end of the 20-year lease. The Company contributed approximately $9.3 million towards the tenant-directed improvements, of which $3.2 million is being refunded during years six through twenty through reduced rental payments. The landlord paid approximately $11.9 million towards the purchase of the building, land and the tenant-directed improvements. The Company placed the building in service in October 2008.

 

The leased building is being depreciated using a straight line method over the 20 year lease term to a residual value. The landlord liability is being amortized over the 20 years using the effective interest method. Lease payments allocated to the landlord liability are accounted for as debt service payments on that liability using the finance method of accounting per ASC 840-40-55.

 

The Company was required to deposit the equivalent of one year of base rent in accordance with the lease. When the Company meets the minimum cash balance required by the lease, the deposit will be returned to the Company. The approximate $1.7 million deposit is included in non-current assets at December 31, 2016 and September 30, 2016.

 

Future minimum lease payments under the San Tomas lease as of December 31, 2016 are as follows:

 

Nine months ending September 30, 2017 $     1,269,000
Year ending September 30,  
2018 1,747,000
2019 1,808,000
2020 1,872,000
2021 1,937,000
2022 2,004,000
Thereafter 13,758,000
Total future minimum lease obligation     24,395,000
Less imputed interest on financing obligation (11,333,000)
Net present value of financing obligation $     13,062,000

 

The Company subleases a portion of its rental space on a month-to-month term lease, which requires a 30 day notice for termination. The Company receives approximately $6,000 per month in rent for the sub-leased space.

 

The Company leases its research and development laboratory under a 60 month lease which expires February 28, 2017. In September 2016, the lease was extended through February 28, 2022. The operating lease includes escalating rental payments. The Company is recognizing the related rent expense on a straight line basis over the full 60 month term of the lease at the rate of approximately $11,000 per month. As of December 31, 2016 and September 30, 2016, the Company has recorded a deferred rent liability of approximately $1,000 and $2,000, respectively.

 

The Company leases its office headquarters under a 60 month lease which expires June 30, 2020. The operating lease includes escalating rental payments. The Company is recognizing the related rent expense on a straight line basis over the full 60 month term of the lease at the rate approximately $8,000 per month. As of December 31, 2016 and September 30, 2016, the Company has recorded a deferred rent liability of approximately $18,000.

 

As of December 31, 2016, material contractual obligations, excluding the San Tomas lease, consisting of operating lease payments are as follows:

 

Nine months ending September 30, 2017 $ 183,000
Year ending September 30,  
2018 251,000
2019 258,000
2020 238,000
2021 163,000
2022 69,000
Total $ 1,162,000

 

During the three months ended December 31, 2016, the Company leased office equipment under a capital lease arrangement. The term of the capital lease is 60 months and expires on October 31, 2021. The monthly lease payment is $505. The lease bears interest at approximately 6.25% per annum. The Company’s previous equipment lease expired on September 30, 2016.

 

XML 21 R12.htm IDEA: XBRL DOCUMENT v3.8.0.1
G. PATENTS
3 Months Ended
Dec. 31, 2016
Accounting Policies [Abstract]  
G. PATENTS

During the three months ended December 31, 2016 and 2015, no patent impairment charges were recorded. For the three months ended December 31, 2016 and 2015, amortization of patent costs totaled approximately $9,000. The total estimated future amortization expense is as follows:

 

Nine months ending September 30, 2017   $ 27,433  
Year ending September 30,        
2018     36,379  
2019     34,676  
2020     31,483  
2021     28,183  
2022     24,380  
Thereafter     64,733  
Total   $ 247,267  

 

XML 22 R13.htm IDEA: XBRL DOCUMENT v3.8.0.1
H. EARNINGS PER COMMON SHARE
3 Months Ended
Dec. 31, 2016
Accounting Policies [Abstract]  
H. EARNINGS PER COMMON SHARE

The following table provides the details of the basic and diluted earnings per-share computations:

 

    Three Months Ended December 31, 2016  
    Net Income – Restated (1)   Weighted Average Shares     EPS  
Basic earnings per share   3,521,153       5,994,431     0.59  
Gain on derivatives(2)     (1,556,754 )     90,277          
                         
Dilutive earnings per share   1,964,399       6,084,708     0.32  
 (1) See Note I - Restatement                      
 (2) Includes certain Series CC, DD, EE and FF warrants                      

 

    Three Months Ended December 31, 2015  
    Net Income – Restated (1)   Weighted Average Shares     EPS  
Basic earnings per share   2,332,734       4,390,740     0.53  
Conversion of note payable     24,841       74,851          
                         
Dilutive earnings per share   2,357,575       4,465,591     0.53  
 (1) See Note I - Restatement                        

 

The gain on derivatives priced lower than the average market price during the period is excluded from the numerator and the related shares are excluded from the denominator in calculating diluted loss per share.

 

In accordance with the contingently issuable shares guidance of FASB ASC Topic 260, Earnings Per Share, the calculation of diluted net earnings (loss) per share excludes the following securities because their inclusion would have been anti-dilutive as of December 31:

 

    2016     2015  
             
Options and Warrants     6,946,179       2,991,061  
Unvested Restricted Stock     604,000       604,000  
Total     7,550,179       3,595,061  

 

XML 23 R14.htm IDEA: XBRL DOCUMENT v3.8.0.1
I. RESTATEMENT
3 Months Ended
Dec. 31, 2016
I. Restatement  
I. RESTATEMENT

In October 2008, the Company entered into a lease arrangement whereby the Company leased a building owned by a third party, but to which the owner made tenant-directed improvements. Upon commencement of the lease, the Company accounted for the arrangement as an operating lease under ASC 840, Accounting for Leases, whereby the total minimum lease payment obligations under the leases were recognized as monthly rent expense on a straight-line basis over the term of the lease. The cost of the tenant improvements incurred were capitalized as deferred rent and amortized over the 20-year lease term.

 

However, in November 2017, the Company discovered an error in the way it accounted for the lease for the building since it was determined that, as the terms of the original lease required the Company to be responsible for possible cost overruns, (but of which there were none), the Company was deemed to be the owner of the leased building for accounting purposes only under ASC 840-40-55. In addition to the costs it incurred and capitalized for the tenant improvements, the Company should have reflected an asset on its balance sheet for the costs paid by the lessor to purchase and improve the building, as well as a corresponding liability. Upon completion of the improvements, the Company did not meet the “sale-leaseback” criteria under ASC 840-40-25, Accounting for Leases, Sale-Leaseback Transactions due to the Company’s significant continuing involvement with the facility which is considered to be other than a normal leaseback as defined in ASC 840-40-25 and therefore should have treated the lease as a financing obligation and the asset and corresponding liability should not be derecognized.

 

The corrections to the historical financial statements to apply ASC 840-40-25 do not affect the total cash payments the Company has made or is obligated to make under the lease agreement, nor does it change the total expense to be recognized over the lease term. However, the timing and nature of expense is different under this treatment as compared to operating lease treatment. Specifically, the Company should have recognized depreciation, expense on the building it is deemed to own and interest expense on the associated lease financing obligation, instead of rental expense.

 

The accompanying financial statements for three months ended December 31, 2016 have been restated to reflect the correction of the error for the lease accounting. Accumulated deficit at September 30, 2016, was reduced by $276,855. The following is a summary of the restatements:

 

    December 31, 2016  
Balance Sheet

  PREVIOUSLY REPORTED     ADJUSTMENT     RESTATED  
Total current assets   $ 4,522,290     $ (415,003 )   $ 4,107,287  
Other assets     5,405,599       13,738,445       19,144,044  
Total assets     9,927,889       13,323,442       23,251,331  
Total liabilities     5,494,598       13,062,236       18,556,834  
Stockholders' equity     4,433,291       261,206       4,694,497  

 

    September 30, 2016  
Balance Sheet

  PREVIOUSLY REPORTED     ADJUSTMENT     RESTATED  
Total current assets   $ 5,887,646     $ (429,821 )   $ 5,457,825  
Other assets     5,710,601       13,717,699       19,428,300  
Total assets     11,598,247       13,287,878       24,886,125  
Total liabilities     12,554,315       13,011,023       25,565,338  
Stockholders' deficit     (956,068 )     276,855       (679,213 )

 

    Three Months Ended December 31, 2016  
Statement of Operations

  PREVIOUSLY REPORTED     ADJUSTMENT     RESTATED  
Research and development expenses   $ 4,024,856     $ (476,599 )   $ 3,548,257  
Total operating expenses     5,431,865       (476,599 )     4,955,266  
Operating loss     (5,414,607 )     476,599       (4,938,008 )
Interest income (expense), net     23,097       (492,248 )     (469,151 )
Net income     3,536,802       (15,649 )     3,521,153  
                         
Net income per share - basic   $ 0.59             $ 0.59  
Net income per share - diluted   $ 0.33             $ 0.32  

 

    Three Months Ended December 31, 2015  
Statement of Operation

  PREVIOUSLY REPORTED     ADJUSTMENT     RESTATED  
Research and development expenses   $ 5,169,507     $ (476,599 )   $ 4,692,908  
Total operating expenses     5,804,108       (476,599 )     5,327,509  
Operating loss     (5,783,132 )     476,599       (5,306,533 )
Interest income (expense), net     1,985       (485,678 )     (483,693 )
Net income     2,341,813       (9,079 )     2,332,734  
                         
Net income per share - basic and diluted   $ 0.53             $ 0.53  

 

    Accumulated Deficit  
PREVIOUSLY REPORTED, SEPTEMBER 30, 2016   $ (285,667,977 )
ADJUSTMENT     276,855  
RESTATED BALANCE, SEPTEMBER 30, 2016     (285,391,122 )
         
Net income - RESTATED     3,521,153  
BALANCE, DECEMBER 31, 2016   $ (281,869,969 )
XML 24 R15.htm IDEA: XBRL DOCUMENT v3.8.0.1
J. SUBSEQUENT EVENTS
3 Months Ended
Dec. 31, 2016
Subsequent Events [Abstract]  
J. SUBSEQUENT EVENTS

The Company has evaluated subsequent events through the date these financial statements were filed and determined there are no subsequent events that require disclosure.

XML 25 R16.htm IDEA: XBRL DOCUMENT v3.8.0.1
A. BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (POLICIES)
3 Months Ended
Dec. 31, 2016
A. Basis Of Presentation And Summary Of Significant Accounting Policies Policies  
Basis of Presentation

The accompanying condensed financial statements of CEL-SCI Corporation (the Company) are unaudited and certain information and footnote disclosures normally included in the annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been omitted pursuant to the rules and regulations of the Securities and Exchange Commission. While management of the Company believes that the disclosures presented are adequate to make the information presented not misleading, these interim condensed financial statements should be read in conjunction with the financial statements and notes included in the Company’s annual report on Form 10-K for the year ended September 30, 2016.

 

In the opinion of management, the accompanying unaudited condensed financial statements contain all accruals and adjustments (each of which is of a normal recurring nature) necessary for a fair presentation of the Company’s financial position as of December 31, 2016 and the results of its operations for the three months then ended. The condensed balance sheet as of September 30, 2016 is derived from the September 30, 2016 audited financial statements. Significant accounting policies have been consistently applied in the interim financial statements and the annual financial statements. The results of operations for the three months ended December 31, 2016 and 2015 are not necessarily indicative of the results to be expected for the entire year.

 

The financial statements have been prepared assuming that the Company will continue as a going concern, but due to recurring losses from operations and future liquidity needs, there is substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. Refer to discussion in Note B.

Research and Office Equipment and Leasehold Improvements

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.

Patents

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 its disposition, is less than the carrying value of the asset. The amount of the impairment loss would be the difference between the estimated fair value of the asset and its carrying value.

Research and Development Costs

Research and Development Costs - Research and development costs are expensed as incurred.

 

Income Taxes

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.  A full valuation allowance was recorded against the deferred tax assets as of December 31, 2016 and September 30, 2016.

Derivative Instruments

Derivative Instruments – The Company has entered into financing arrangements that consist of freestanding derivative instruments that contain embedded derivative features. The Company accounts for these arrangements in accordance with Accounting Standards Codification (ASC) 815, “Accounting for Derivative Instruments and Hedging Activities.” In accordance with accounting principles generally accepted in the United States (U.S. GAAP), derivative instruments and hybrid instruments are recognized as either assets or liabilities in the 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. The Company determines 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. The derivative liabilities are re-measured at fair value at the end of each interim period as long as they are outstanding.

Deferred Rent

Deferred Rent– Certain of the Company’s operating leases provide for minimum annual payments that adjust over the life of the lease.  The aggregate minimum annual payments are expensed on a straight-line basis over the minimum lease term. The Company recognizes a deferred rent liability for rent escalations when the amount of straight-line rent exceeds the lease payments, and reduces the deferred rent liability when the lease payments exceed the straight-line rent expense.  For tenant improvement allowances and rent holidays, the Company records a deferred rent liability and amortizes the deferred rent over the lease term as a reduction to rent expense.

 

Leases

Leases – Leases are categorized as either operating or capital leases at inception. Operating lease costs are recognized on a straight-line basis over the term of the lease. An asset and a corresponding liability for the capital lease obligation are established for the cost of capital leases. The capital lease obligation is amortized over the life of the lease. For build-to-suit leases, the Company establishes an asset and liability for the estimated construction costs incurred to the extent that it is involved in the construction of structural improvements or takes construction risk prior to the commencement of the lease. Upon occupancy of facilities under build-to-suit leases, the Company assesses whether these arrangements qualify for sales recognition under the sale-leaseback accounting guidance. If a lease does not meet the criteria to qualify for a sale-leaseback transaction, the established asset and liability remain on the Company's balance sheet.

 

Stock-Based Compensation

Stock-Based Compensation – Compensation cost for all stock-based awards is measured at fair value as of the grant date in accordance with the provisions of ASC 718 “Compensation – Stock Compensation.” The fair value of stock options is calculated using the Black-Scholes option pricing model. The Black-Scholes model requires various judgmental assumptions including volatility and expected option life. The stock-based compensation cost is recognized on the straight line allocation method as expense over the requisite service or vesting period.

 

Equity instruments issued to non-employees are accounted for in accordance with ASC 505-50, “Equity-Based Payments to Non Employees.” Accordingly, compensation is recognized when goods or services are received and is measured using the Black-Scholes valuation model. The Black-Scholes model requires various judgmental assumptions regarding the fair value of the equity instruments at the measurement date and the expected life of the options.

 

The Company has Incentive Stock Option Plans, Non-Qualified Stock Option Plans, a Stock Compensation Plan, Stock Bonus Plans and an Incentive Stock Bonus Plan. In some cases, these Plans are collectively referred to as the "Plans". All Plans have been approved by the stockholders.

 

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 interest rate assumption was based on the U.S. Treasury rate at date of the grant with term equal to the expected life of the option. 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. 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.

 

Vesting of restricted stock granted under the Incentive Stock Bonus Plan is subject to service, performance and market conditions and meets the classification of equity awards. These awards were measured at market value on the grant-dates for issuances where the attainment of performance criteria is likely and at fair value on the grant-dates, using a Monte Carlo simulation for issuances where the attainment of performance criteria is uncertain. The total compensation cost will be expensed over the estimated requisite service period.

 

New Accounting Pronouncements

In February 2016, the FASB issued ASU 2016-02, Leases, which will require most leases (with the exception of leases with terms of less than one year) to be recognized on the balance sheet as an asset and a lease liability. Leases will be classified as an operating lease or a financing lease. Operating leases are expensed using the straight-line method whereas financing leases will be treated similarly to a capital lease under the current standard. The new standard will be effective for annual and interim periods, within those fiscal years, beginning after December 15, 2018, but early adoption is permitted. The new standard must be presented using the modified retrospective method beginning with the earliest comparative period presented. The Company is currently evaluating the effect of the new standard on its financial statements and related disclosures.

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C. STOCKHOLDERS EQUITY (Tables)
3 Months Ended
Dec. 31, 2016
C. Stockholders Equity Tables  
Stock options, stock bonuses and compensation granted by the Company

Stock options, stock bonuses and compensation granted by the Company as of December 31, 2016 are as follows:

 

Name of Plan   Total Shares Reserved Under Plans     Shares Reserved for Outstanding Options     Shares Issued     Remaining Options/Shares Under Plans  
                         
Incentive Stock Options Plans     138,400       65,959       N/A       60,453  
Non-Qualified Stock Option Plans     387,200       262,531       N/A       95,564  
Stock Bonus Plans     223,760       N/A       160,157       63,570  
Stock Compensation Plan     134,000       N/A       83,490       49,188  
Incentive Stock Bonus Plan     640,000       N/A       624,000       16,000  

 

Stock options, stock bonuses and compensation granted by the Company as of September 30, 2016 are as follows:

 

Name of Plan   Total Shares Reserved Under Plans     Shares Reserved for Outstanding Options     Shares Issued     Remaining Options/Shares Under Plans  
                         
Incentive Stock Option Plans     138,400       65,959       N/A       60,453  
Non-Qualified Stock Option Plans     387,200       277,613       N/A       82,370  
Bonus Plans     223,760       N/A       26,448       97,278  
Stock Compensation Plan     134,000       N/A       79,401       53,276  
Incentive Stock Bonus Plan     640,000       N/A       624,000       16,000  

 

Stock option activity:

 

    Three Months Ended December 31,
    2016     2015
Granted     -       -
Expired     15,081       -
Forfeited     -       919

Schedule of employees and non-employees stock compensation
    Three months Ended December 31,
    2016     2015
Employees   $ 312,375     $ 427,910
Non-employees   $ 78,553     $ 329,195
Derivative Liabilities, Warrants and Other Options
Warrant   Issue Date   Shares Issuable upon Exercise of Warrant     Exercise Price   Expiration Date   Reference  
                         
Series P   2/10/12     23,600     112.50   3/6/17      
Series DD   12/8/16     1,360,960     4.50   6/8/17     1  
Series EE   12/8/16     1,360,960     4.50   9/8/17     1  
Series N   8/18/08     113,785     13.18   8/18/17        
Series U   4/17/14     17,821     43.75   10/17/17     1  
Series S   10/11/13 -10/24/14     1,037,120     31.25   10/11/18     1  
Series V   5/28/15     810,127     19.75   5/28/20     1  
Series W   10/28/15     688,930     16.75   10/28/20     1  
Series X   1/13/16     120,000     9.25   1/13/21        
Series Y   2/15/16     26,000     12.00   2/15/21        
Series Z   5/23/16     264,000     13.75   11/23/21     1  
Series ZZ   5/23/16     20,000     13.75   5/18/21     1  
Series BB   8/26/16     16,000     13.75   8/22/21     1  
Series FF   12/8/16     68,048     4.00   12/1/21     1  
Series CC   12/8/16     680,480     5.00   12/8/21     1  
Series AA   8/26/16     200,000     13.75   2/22/22     1  
Consultants   3/6/12- 7/1/16     23,000     9.25- $87.50   3/5/17- 6/30/19     2  
Tabular disclosure of derivative liabilities at fair value
    December 31, 2016     September 30, 2016  
Series S warrants   $ 490,040     $ 3,111,361  
Series U warrants     -       -  
Series V warrants     202,532       1,620,253  
Series W warrants     132,254       1,799,858  
Series Z warrants     101,817       970,604  
Series ZZ warrants     6,725       70,609  
Series AA warrants     84,092       763,661  
Series BB warrants     5,916       58,588  
Series CC warrants     455,931       -  
Series DD warrants     72,353       -  
Series EE warrants     176,804       -  
Series FF warrants     54,242       -  
                 
Total warrant liabilities   $ 1,782,706     $ 8,394,934  
Schedule Of Gains and (Losses) on Derivative Liabilities
    2016     2015  
Series S warrants   $ 2,621,321     $ 2,826,153  
Series U warrants     -       31,186  
Series V warrants     1,417,721       3,240,506  
Series W warrants     1,667,604       2,025,115  
Series Z warrants     868,787       -  
Series ZZ warrants     63,884       -  
Series AA warrants     679,569       -  
Series BB warrants     52,672       -  
Series CC warrants     604,492       -  
Series DD warrants     370,919       -  
Series EE warrants     514,603       -  
Series FF warrants     66,740       -  
                 
Net gain on warrant liabilities   $ 8,928,312     $ 8,122,960  
XML 27 R18.htm IDEA: XBRL DOCUMENT v3.8.0.1
D. FAIR VALUE MEASUREMENTS (Tables)
3 Months Ended
Dec. 31, 2016
D. Fair Value Measurements Tables  
Measured at fair value on a recurring basis

The table below sets forth the assets and liabilities measured at fair value on a recurring basis, by input level, in the condensed balance sheet at December 31, 2016:

 

    Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1)     Significant Other Observable Inputs (Level 2)     Significant Unobservable Inputs (Level 3)     Total  
                         
Derivative instruments   $ 490,040     $ -     $ 1,292,666     $ 1,782,706  

 

The table below sets forth the assets and liabilities measured at fair value on a recurring basis, by input level, in the condensed balance sheet at September 30, 2016:

 

    Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1)     Significant Other Observable Inputs (Level 2)     Significant Unobservable Inputs (Level 3)     Total  
                         
Derivative instruments   $ 3,111,361     $ -     $ 5,283,573     $ 8,394,934  

 

Reconciliation of beginning and ending balances related to fair value measurements using significant unobservable inputs (Level 3)
    3 Months Ended     12 Months Ended  
    December 31, 2016     September 30, 2016  
             
Beginning balance   $ 5,283,573     $ 6,323,032  
Issuances     2,316,084       8,722,073  
Realized and unrealized gains     (6,306,991 )     (9,761,532 )
Ending balance   $ 1,292,666     $ 5,283,573  
XML 28 R19.htm IDEA: XBRL DOCUMENT v3.8.0.1
F. COMMITMENTS AND CONTINGENCIES (Tables)
3 Months Ended
Dec. 31, 2016
F. Commitments And Contingencies Tables  
Future minimum lease payments
Nine months ending September 30, 2017 $     1,269,000
Year ending September 30,  
2018 1,747,000
2019 1,808,000
2020 1,872,000
2021 1,937,000
2022 2,004,000
Thereafter 13,758,000
Total future minimum lease obligation     24,395,000
Less imputed interest on financing obligation (11,333,000)
Net present value of financing obligation $     13,062,000
Operating lease payments
Nine months ending September 30, 2017 $ 183,000
Year ending September 30,  
2018 251,000
2019 258,000
2020 238,000
2021 163,000
2022 69,000
Total $ 1,162,000
XML 29 R20.htm IDEA: XBRL DOCUMENT v3.8.0.1
G. PATENTS (Tables)
3 Months Ended
Dec. 31, 2016
G. Patents Tables  
Schedule of total estimated future amortization
Nine months ending September 30, 2017   $ 27,433  
Year ending September 30,        
2018     36,379  
2019     34,676  
2020     31,483  
2021     28,183  
2022     24,380  
Thereafter     64,733  
Total   $ 247,267  
XML 30 R21.htm IDEA: XBRL DOCUMENT v3.8.0.1
H. LOSS PER COMMON SHARE (Tables)
3 Months Ended
Dec. 31, 2016
H. Loss Per Common Share Tables  
Computation of dilutive net loss per share
    Three Months Ended December 31, 2016  
    Net Income – Restated (1)   Weighted Average Shares     EPS  
Basic earnings per share   3,521,153       5,994,431     0.59  
Gain on derivatives(2)     (1,556,754 )     90,277          
                         
Dilutive earnings per share   1,964,399       6,084,708     0.32  
 (1) See Note I - Restatement                      
 (2) Includes certain Series CC, DD, EE and FF warrants                      

 

    Three Months Ended December 31, 2015  
    Net Income – Restated (1)   Weighted Average Shares     EPS  
Basic earnings per share   2,332,734       4,390,740     0.53  
Conversion of note payable     24,841       74,851          
                         
Dilutive earnings per share   2,357,575       4,465,591     0.53  
 (1) See Note I - Restatement                        

Antidilutive securities
    2016     2015  
             
Options and Warrants     6,946,179       2,991,061  
Unvested Restricted Stock     604,000       604,000  
Total     7,550,179       3,595,061  
XML 31 R22.htm IDEA: XBRL DOCUMENT v3.8.0.1
I. RESTATEMENT (Tables)
3 Months Ended
Dec. 31, 2016
I. Restatement Tables  
Restatements
    December 31, 2016  
Balance Sheet   PREVIOUSLY REPORTED     ADJUSTMENT     RESTATED  
Total current assets   $ 4,522,290     $ (415,003 )   $ 4,107,287  
Other assets     5,405,599       13,738,445       19,144,044  
Total assets     9,927,889       13,323,442       23,251,331  
Total liabilities     5,494,598       13,062,236       18,556,834  
Stockholders' equity     4,433,291       261,206       4,694,497  

 

    September 30, 2016  
Balance Sheet   PREVIOUSLY REPORTED     ADJUSTMENT     RESTATED  
Total current assets   $ 5,887,646     $ (429,821 )   $ 5,457,825  
Other assets     5,710,601       13,717,699       19,428,300  
Total assets     11,598,247       13,287,878       24,886,125  
Total liabilities     12,554,315       13,011,023       25,565,338  
Stockholders' deficit     (956,068 )     276,855       (679,213 )

 

    Three Months Ended December 31, 2016  
Statement of Operations   PREVIOUSLY REPORTED     ADJUSTMENT     RESTATED  
Research and development expenses   $ 4,024,856     $ (476,599 )   $ 3,548,257  
Total operating expenses     5,431,865       (476,599 )     4,955,266  
Operating loss     (5,414,607 )     476,599       (4,938,008 )
Interest income (expense), net     23,097       (492,248 )     (469,151 )
Net income     3,536,802       (15,649 )     3,521,153  
                         
Net income per share - basic   $ 0.59             $ 0.59  
Net income per share - diluted   $ 0.33             $ 0.32  

 

    Three Months Ended December 31, 2015  
Statement of Operation   PREVIOUSLY REPORTED     ADJUSTMENT     RESTATED  
Research and development expenses   $ 5,169,507     $ (476,599 )   $ 4,692,908  
Total operating expenses     5,804,108       (476,599 )     5,327,509  
Operating loss     (5,783,132 )     476,599       (5,306,533 )
Interest income (expense), net     1,985       (485,678 )     (483,693 )
Net income     2,341,813       (9,079 )     2,332,734  
                         
Net income per share - basic and diluted   $ 0.53             $ 0.53  

 

    Accumulated Deficit  
PREVIOUSLY REPORTED, SEPTEMBER 30, 2016   $ (285,667,977 )
ADJUSTMENT     276,855  
RESTATED BALANCE, SEPTEMBER 30, 2016     (285,391,122 )
         
Net income - RESTATED     3,521,153  
BALANCE, DECEMBER 31, 2016   $ (281,869,969 )

 

XML 32 R23.htm IDEA: XBRL DOCUMENT v3.8.0.1
C. STOCKHOLDERS EQUITY (Details) - shares
Dec. 31, 2016
Sep. 30, 2016
Incentive Stock Option Plans    
Total Shares Reserved Under Plans 138,400 138,400
Shares Reserved for Outstanding Options 65,959 65,959
Shares Issued 0 0
Remaining Options/Shares Under Plans 60,453 60,453
Non-Qualified Stock Option Plans    
Total Shares Reserved Under Plans 387,200 387,200
Shares Reserved for Outstanding Options 262,531 277,613
Shares Issued 0 0
Remaining Options/Shares Under Plans 95,564 82,370
Bonus Plans    
Total Shares Reserved Under Plans 223,760 223,760
Shares Reserved for Outstanding Options 0 0
Shares Issued 160,157 26,448
Remaining Options/Shares Under Plans 63,570 97,278
Stock Compensation Plan    
Total Shares Reserved Under Plans 134,000 134,000
Shares Reserved for Outstanding Options 0 0
Shares Issued 83,490 79,401
Remaining Options/Shares Under Plans 49,188 53,276
Incentive Stock Bonus Plan    
Total Shares Reserved Under Plans 640,000 640,000
Shares Reserved for Outstanding Options 0 0
Shares Issued 624,000 624,000
Remaining Options/Shares Under Plans 16,000 16,000
XML 33 R24.htm IDEA: XBRL DOCUMENT v3.8.0.1
C. STOCKHOLDERS EQUITY (Details 1) - shares
3 Months Ended
Dec. 31, 2016
Dec. 31, 2015
C. Stockholders Equity Details 1    
Granted 0 0
Expired 15,081 0
Forfeited 0 919
XML 34 R25.htm IDEA: XBRL DOCUMENT v3.8.0.1
C. STOCKHOLDERS EQUITY (Details 2) - USD ($)
3 Months Ended
Dec. 31, 2016
Dec. 31, 2015
C. Stockholders Equity Details 2    
Employees $ 312,375 $ 247,910
Non-employees $ 75,883 $ 329,195
XML 35 R26.htm IDEA: XBRL DOCUMENT v3.8.0.1
C. STOCKHOLDERS EQUITY (Details 3)
3 Months Ended
Dec. 31, 2016
$ / shares
shares
Series P [Member]  
STOCKHOLDERS' EQUITY  
Issue Date 2/10/2012
Shares Issuable upon Exercise of Warrant | shares 23,600
Exercise Price $ 112.50
Expiration Date 3/6/2017
Series DD [Member]  
STOCKHOLDERS' EQUITY  
Issue Date 12/8/2016
Shares Issuable upon Exercise of Warrant | shares 1,360,960
Exercise Price $ 4.50
Expiration Date 6/8/2017
Series EE [Member]  
STOCKHOLDERS' EQUITY  
Issue Date 12/8/2016
Shares Issuable upon Exercise of Warrant | shares 1,360,960
Exercise Price $ 4.50
Expiration Date 9/8/2017
Series N [Member]  
STOCKHOLDERS' EQUITY  
Issue Date 8/18/2008
Shares Issuable upon Exercise of Warrant | shares 113,785
Exercise Price $ 13.18
Expiration Date 8/18/2017
Series U [Member]  
STOCKHOLDERS' EQUITY  
Issue Date 4/17/2014
Shares Issuable upon Exercise of Warrant | shares 17,821
Exercise Price $ 43.75
Expiration Date 10/17/2017
Series S [Member]  
STOCKHOLDERS' EQUITY  
Issue Date 10/11/13 -10/24/14
Shares Issuable upon Exercise of Warrant | shares 1,037,120
Exercise Price $ 31.25
Expiration Date 10/11/2018
Series V [Member]  
STOCKHOLDERS' EQUITY  
Issue Date 5/28/2015
Shares Issuable upon Exercise of Warrant | shares 810,127
Exercise Price $ 19.75
Expiration Date 5/28/2020
Series W [Member]  
STOCKHOLDERS' EQUITY  
Issue Date 10/28/2015
Shares Issuable upon Exercise of Warrant | shares 688,930
Exercise Price $ 16.75
Expiration Date 10/28/2020
Series X [Member]  
STOCKHOLDERS' EQUITY  
Issue Date 1/13/2016
Shares Issuable upon Exercise of Warrant | shares 120,000
Exercise Price $ 9.25
Expiration Date 1/13/2021
Series Y [Member]  
STOCKHOLDERS' EQUITY  
Issue Date 2/15/2016
Shares Issuable upon Exercise of Warrant | shares 26,000
Exercise Price $ 12.00
Expiration Date 2/15/2021
Series Z [Member]  
STOCKHOLDERS' EQUITY  
Issue Date 5/23/2016
Shares Issuable upon Exercise of Warrant | shares 264,000
Exercise Price $ 13.75
Expiration Date 11/23/2021
Series ZZ [Member]  
STOCKHOLDERS' EQUITY  
Issue Date 5/23/2016
Shares Issuable upon Exercise of Warrant | shares 20,000
Exercise Price $ 13.75
Expiration Date 5/18/2021
Series BB [Member]  
STOCKHOLDERS' EQUITY  
Issue Date 8/26/2016
Shares Issuable upon Exercise of Warrant | shares 16,000
Exercise Price $ 13.75
Expiration Date 8/22/2021
Series FF [Member]  
STOCKHOLDERS' EQUITY  
Issue Date 12/8/2016
Shares Issuable upon Exercise of Warrant | shares 68,048
Exercise Price $ 4.00
Expiration Date 12/1/2021
Series CC [Member]  
STOCKHOLDERS' EQUITY  
Issue Date 12/8/2016
Shares Issuable upon Exercise of Warrant | shares 680,480
Exercise Price $ 5.00
Expiration Date 12/8/2021
Series AA [Member]  
STOCKHOLDERS' EQUITY  
Issue Date 8/26/2016
Shares Issuable upon Exercise of Warrant | shares 200,000
Exercise Price $ 13.75
Expiration Date 2/22/2022
Consultants [Member]  
STOCKHOLDERS' EQUITY  
Issue Date 3/6/12- 7/1/16
Shares Issuable upon Exercise of Warrant | shares 23,000
Exercise Price Minimum $ 9.25
Exercise Price Maximum $ 87.50
Expiration Date 3/5/17- 6/30/19
XML 36 R27.htm IDEA: XBRL DOCUMENT v3.8.0.1
C. STOCKHOLDERS EQUITY (Details 4) - USD ($)
3 Months Ended
Dec. 31, 2016
Dec. 31, 2015
Sep. 30, 2016
C. Stockholders Equity Details 4      
Series S warrants $ 490,040   $ 3,111,361
Series U warrants 0   0
Series V warrants 202,532   1,620,253
Series W warrants 132,254   1,799,858
Series Z warrants 101,817   970,604
Series ZZ warrants 6,725   70,609
Series AA warrants 84,092   763,661
Series BB warrants 5,916   58,588
Series CC warrants 455,931   0
Series DD warrants 72,353   0
Series EE warrants 176,804   0
Series FF warrants 54,242   0
Total warrant liabilities 1,782,706   $ 8,394,934
Series S warrants 2,621,321 $ 2,826,153  
Series U warrants 0 31,186  
Series V warrants 1,417,721 3,240,506  
Series W warrants 1,667,604 2,025,115  
Series Z warrants 868,787 0  
Series ZZ warrants 63,884 0  
Series AA warrants 679,569 0  
Series BB warrants 52,672 0  
Series CC warrants 604,492 0  
Series DD warrants 370,919 0  
Series EE warrants 514,603 0  
Series FF warrants 66,740 0  
Net gain on warrant liabilities $ 8,928,312 $ 8,122,960  
XML 37 R28.htm IDEA: XBRL DOCUMENT v3.8.0.1
D. FAIR VALUE MEASUREMENTS (Details) - USD ($)
Dec. 31, 2016
Sep. 30, 2016
Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1)    
Derivative instruments $ 490,040 $ 3,111,361
Significant Other Observable Inputs (Level 2)    
Derivative instruments 0 0
Significant Unobservable Inputs (Level 3)    
Derivative instruments 1,292,666 5,283,573
Total    
Derivative instruments $ 1,782,706 $ 8,394,934
XML 38 R29.htm IDEA: XBRL DOCUMENT v3.8.0.1
D. FAIR VALUE MEASUREMENTS (Details 1) - USD ($)
3 Months Ended 12 Months Ended
Dec. 31, 2016
Sep. 30, 2016
D. Fair Value Measurements Details 1    
Beginning balance $ 5,283,573 $ 6,323,032
Issuances 2,316,084 8,722,073
Realized and unrealized gains (6,306,991) (9,761,532)
Ending balance $ 1,292,666 $ 5,283,573
XML 39 R30.htm IDEA: XBRL DOCUMENT v3.8.0.1
E. RELATED PARTY TRANSACTIONS (Details Narrative) - USD ($)
3 Months Ended
Dec. 31, 2016
Dec. 31, 2015
E. Related Party Transactions Details Narrative    
Interest expense paid to Mr. de Clara $ 0 $ 33,000
XML 40 R31.htm IDEA: XBRL DOCUMENT v3.8.0.1
F. COMMITMENTS AND CONTINGENCIES (Details)
Dec. 31, 2016
USD ($)
F. Commitments And Contingencies Details  
Nine months ending September 30, 2017 $ 1,269,000
Year ending September 30, 2018 1,747,000
Year ending September 30, 2019 1,808,000
Year ending September 30, 2020 1,872,000
Year ending September 30, 2021 1,937,000
Year ending September 30, 2022 2,004,000
Thereafter 13,758,000
Total future minimum lease obligation 24,395,000
Less imputed interest on financing obligation (11,333,000)
Net present value of financing obligation $ 13,062,000
XML 41 R32.htm IDEA: XBRL DOCUMENT v3.8.0.1
F. COMMITMENTS AND CONTINGENCIES (Details 1)
Dec. 31, 2016
USD ($)
F. Commitments And Contingencies Details  
Nine months ending September 30, 2017 $ 183,000
Year ending September 30, 2018 251,000
Year ending September 30, 2019 258,000
Year ending September 30, 2020 238,000
Year ending September 30, 2021 163,000
Year ending September 30, 2022 69,000
Total $ 1,162,000
XML 42 R33.htm IDEA: XBRL DOCUMENT v3.8.0.1
G. PATENTS (Details) - USD ($)
Dec. 31, 2016
Sep. 30, 2016
G. Patents Details    
Nine months ending September 30, 2017 $ 27,433  
Year ending September 30, 2018 36,379  
Year ending September 30, 2019 34,676  
Year ending September 30, 2020 31,483  
Year ending September 30, 2021 28,183  
Year ending September 30, 2022 24,380  
Thereafter 64,733  
Total $ 247,267 $ 256,547
XML 43 R34.htm IDEA: XBRL DOCUMENT v3.8.0.1
G. PATENTS (Details Narrative) - USD ($)
3 Months Ended
Dec. 31, 2016
Dec. 31, 2015
G. Patents Details Narrative    
Patent impairment charges $ 0 $ 0
Amortization of patent costs $ 9,000 $ 9,000
XML 44 R35.htm IDEA: XBRL DOCUMENT v3.8.0.1
H. LOSS PER COMMON SHARE (Details) - USD ($)
3 Months Ended
Dec. 31, 2016
Dec. 31, 2015
H. Loss Per Common Share Details    
Net Income $ 3,521,153 $ 2,332,734
Gain on derivatives (1,556,754)  
Conversion of note payable   24,841
Dilutive earnings per share $ 1,964,399 $ 2,357,575
Weighted Average Shares - Basic 5,994,431 4,390,740
Gain on derivatives, shares 90,277  
Conversion of note payable   74,851
Weighted Average Shares - Diluted 6,084,708 4,465,591
Basic earnings per share $ 0.59 $ 0.53
Dilutive earnings per share $ 0.32 $ 0.53
XML 45 R36.htm IDEA: XBRL DOCUMENT v3.8.0.1
H. LOSS PER COMMON SHARE (Details 1) - shares
3 Months Ended
Dec. 31, 2016
Dec. 31, 2015
H. Loss Per Common Share Details 1    
Options and Warrants 6,946,179 2,991,061
Unvested Restricted Stock 604,000 604,000
Total 7,550,179 3,595,061
XML 46 R37.htm IDEA: XBRL DOCUMENT v3.8.0.1
I. RESTATEMENT (Details) - USD ($)
Dec. 31, 2016
Sep. 30, 2016
Total current assets $ 4,107,287 $ 5,457,825
Other assets 19,144,044 19,428,300
Total assets 23,251,331 24,886,125
Total liabilities 18,556,834 25,565,338
Stockholders' deficit 4,694,497 (679,213)
Previously Reported    
Total current assets 4,522,290 5,887,646
Other assets 5,405,599 5,710,601
Total assets 9,927,889 11,598,247
Total liabilities 5,494,598 12,554,315
Stockholders' deficit 4,433,291 (956,068)
Adjustment    
Total current assets (415,003) (429,821)
Other assets 13,738,445 13,717,699
Total assets 13,323,442 13,287,878
Total liabilities 13,062,236 13,011,023
Stockholders' deficit $ 261,206 $ 276,855
XML 47 R38.htm IDEA: XBRL DOCUMENT v3.8.0.1
I. RESTATEMENT (Details 1) - USD ($)
3 Months Ended
Dec. 31, 2016
Dec. 31, 2015
Research and development expenses $ 3,548,257 $ 4,692,908
Total operating expenses 4,955,266 5,327,509
Operating loss (4,938,008) (5,306,533)
Interest income (expense), net (469,151) (483,693)
Net income $ 3,521,153 $ 2,332,734
Net income per share - basic $ 0.59 $ 0.53
Net income per share - diluted $ 0.32 0.53
Net income per share - basic and diluted   $ 0.53
Previously Reported    
Research and development expenses $ 4,024,856 $ 5,169,507
Total operating expenses 5,431,865 5,804,108
Operating loss (5,414,607) (5,783,132)
Interest income (expense), net 23,097 1,985
Net income $ 3,536,802 $ 2,341,813
Net income per share - basic $ 0.59  
Net income per share - diluted $ 0.33  
Net income per share - basic and diluted   $ 0.53
Adjustment    
Research and development expenses $ (476,599) $ (476,599)
Total operating expenses (476,599) (476,599)
Operating loss 476,599 476,599
Interest income (expense), net (492,248) (485,678)
Net income $ (15,649) $ (9,079)
XML 48 R39.htm IDEA: XBRL DOCUMENT v3.8.0.1
I. RESTATEMENT (Details 2) - USD ($)
3 Months Ended
Dec. 31, 2016
Dec. 31, 2015
Sep. 30, 2016
Accumulated Deficit $ (281,869,969)   $ (285,391,122)
Net income 3,521,153 $ 2,332,734  
Previously Reported      
Accumulated Deficit     (285,667,977)
Net income 3,536,802 2,341,813  
Adjustment      
Accumulated Deficit     $ 276,855
Net income $ (15,649) $ (9,079)  
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