0001554795-14-000155.txt : 20140307 0001554795-14-000155.hdr.sgml : 20140307 20140307160102 ACCESSION NUMBER: 0001554795-14-000155 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 10 CONFORMED PERIOD OF REPORT: 20140131 FILED AS OF DATE: 20140307 DATE AS OF CHANGE: 20140307 FILER: COMPANY DATA: COMPANY CONFORMED NAME: GENEREX BIOTECHNOLOGY CORP CENTRAL INDEX KEY: 0001059784 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 820490211 STATE OF INCORPORATION: DE FISCAL YEAR END: 0731 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-25169 FILM NUMBER: 14677152 BUSINESS ADDRESS: STREET 1: 33 HARBOUR SQ STREET 2: STE 202 CITY: TORONTO ONTARIO CANADA STATE: A1 ZIP: M5J 2G2 BUSINESS PHONE: 4163642551 MAIL ADDRESS: STREET 1: 33 HARBOUR SQ STREET 2: STE 202 CITY: TORONTO ONTARIO CA STATE: A1 ZIP: M5J 2G2 10-Q 1 gnbt21914form10q.htm FORM 10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

 QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES

EXCHANGE ACT OF 1934

 

For the quarterly period ended January 31, 2014

 

☐  TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES

EXCHANGE ACT OF 1934

 

For the transition period from _________________ to ________________

 

COMMISSION FILE NUMBER: 0-25169

 

GENEREX BIOTECHNOLOGY CORPORATION

(Exact name of registrant as specified in its charter)

 

Delaware   98-0178636

(State or other jurisdiction of

incorporation or organization)

  (IRS Employer Identification No.)

 

555 RICHMOND STREET WEST, SUITE 604

TORONTO, ONTARIO

CANADA M5V 3B1

(Address of principal executive offices)

 

(416) 364-2551 

(Registrant's telephone number, including area code)

 

Indicate by check mark whether the registrant: (1) has filed all reports required by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☑ Yes  ☐ 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” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer  ☐ Accelerated filer  ☐
Non-accelerated filer  ☐ Smaller reporting company  ☑

     

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

 

The number of outstanding shares of the registrant's common stock, par value $.001, was 730,480,474 as of March 3, 2014. 

 
 

 

GENEREX BIOTECHNOLOGY CORPORATION

 

INDEX

 

PART I. FINANCIAL INFORMATION  
   
Item 1.     Financial Statements (unaudited)  
   
Consolidated Balance Sheets -  
January 31, 2014 (unaudited) and July 31, 2013 1
   
Consolidated Statements of Operations - For the three and six-month  
periods ended January 31, 2014 and 2013, and cumulative from  
November 2, 1995 to January 31, 2014 (unaudited) 2
   
Consolidated Statements of Cash Flows - For the three and six-month  
periods ended January 31, 2014 and 2013, and cumulative from  
November 2, 1995 to January 31, 2014 (unaudited) 3
   
Notes to Consolidated Financial Statements (unaudited) 4
   
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 17
   
Item 3. Quantitative and Qualitative Disclosures About Market Risk 30
   
Item 4. Controls and Procedures 31
   
PART II: OTHER INFORMATION  
   
Item 1. Legal Proceedings 31
   
Item 1A. Risk Factors 31
   
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 34
   
Item 3. Defaults Upon Senior Securities 34
   
[Item 4. Removed and Reserved.] -
   
Item 5. Other Information 34
   
Item 6. Exhibits 34
   
Signatures 35

 
 

 

GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
INTERIM CONSOLIDATED BALANCE SHEETS (UNAUDITED)
 
                      January 31, 2014   July 31, 2013
      ASSETS           (Unaudited)   (Audited)
Current Assets:                
  Cash and cash equivalents          $         3,141,212    $         1,708,954
  Other current assets                        102,428                    98,315
      Total Current Assets                     3,243,640               1,807,269
                           
Property and Equipment, Net                          16,440                    85,406
Assets Held for Investment, Net (Note 11)                                --                     640,772
Patents, Net                       2,163,696               2,319,416
                           
      TOTAL ASSETS          $         5,423,776    $         4,852,863
                           
                           
        LIABILITIES AND STOCKHOLDERS’ (DEFICIENCY)/EQUITY        
Current Liabilities:                
  Accounts payable and accrued expenses (Note 5)      $         7,891,679    $         7,661,234
  Deferred revenue                          223,662                  224,843
  Current maturities of long-term debt (Note 11)                              --                     617,665
      Total Current Liabilities                     8,115,341               8,503,742
                           
Derivative Warrant Liability (Note 10)                   5,259,929               5,234,293
                           
Derivative Additional Investment Rights Liability (Note 10)                    126,195               1,256,160
      Total Liabilities                   13,501,465             14,994,195
                           
Commitments and Contingencies (Notes 6 and 7)            
                           
Stockholders’ Deficiency (Note 9):              
  Series A 9% Convertible Preferred Stock, $1,000 par value; authorized 5,500        
    shares, -0- issued shares at January 31, 2014 and July 31, 2013, respectively                          --                             --   
  Series B 9% Convertible Preferred Stock, $1,000 par value; authorized 2,000        
    shares at January 31, 2014 and July 31, 2013, respectively; -0- shares        
    issued and outstanding at January 31, 2014 and July 31, 2013, respectively                          --                             --   
  Series C 9% Convertible Preferred Stock, $1,000 par value; authorized 750         
    shares at January 31, 2014 and July 31, 2013, respectively; -0- shares        
    issued and outstanding at January 31, 2014 and July 31, 2013, respectively                          --                             --   
  Series D 9% Convertible Preferred Stock, $1,000 par value; authorized 750        
    shares at January 31, 2014 and July 31, 2013, respectively; -0- shares        
    issued and outstanding at January 31, 2014 and July 31, 2013, respectively                          --                             --   
  Series E 9% Convertible Preferred Stock, $1,000 par value; authorized 2,450        
    shares at January 31, 2014 and July 31, 2013, respectively; 825 and 930 shares        
    issued and outstanding at January 31, 2014 and July 31, 2013, respectively                          --                             --   
  Common stock, $.001 par value; authorized 1,500,000,000 shares at        
    January 31, 2014 and July 31, 2013, respectively; 696,050,476 and 580,329,160        
    issued and outstanding at January 31, 2014 and July 31, 2013, respectively                  696,050                  580,329
  Additional paid-in capital                 361,399,963           356,401,812
  Deficit accumulated during the development stage           (370,953,051)         (367,888,576)
  Accumulated other comprehensive income                      779,349                  765,103
      Total Stockholders’ Deficiency                   (8,077,689)           (10,141,332)
                           
      TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIENCY    $         5,423,776    $         4,852,863

1
 

GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
INTERIM CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
                                     
                                Cumulative From
                                November 2, 1995
                For the Three Months Ended   For the Six Months Ended   (Date of Inception)
                January 31,   January 31,   January 31,
                2014   2013   2014   2013   2014
                                     
Revenues, net      $                   --       $                   --       $                   --       $                   --         $         5,110,784  
                                     
Cost of Goods Sold                         --                            --                            --                            --                    1,620,375  
                                     
Gross profit                           --                            --                            --                            --                    3,490,409  
                                     
Operating Expenses:                        
  Research and development                 213,599                 500,482                 749,773              1,153,877             134,918,461  
  Research and development - related party                       --                            --                            --                            --                       220,218  
  Selling and marketing                         --                            --                            --                            --                    9,333,214  
  General and administrative                 797,262                 790,298              1,704,139              2,076,934             153,442,930  
  General and administrative - related party                       --                            --                            --                            --                       314,328  
        Total Operating Expenses            1,010,861              1,290,780              2,453,912              3,230,811             298,229,151  
                                     
Operating Loss              (1,010,861)            (1,290,780)            (2,453,912)            (3,230,811)           (294,738,742)  
                                     
Other Income (Expense):                        
  Miscellaneous income                         --                            --                            --                            --                       686,303  
  Income from assets held for investment, net (Note 11)                       --                      40,998                 193,607              1,083,866                 5,773,029  
  Interest income                            23                          82                          46                        307                 7,782,292  
  Interest expense                 (67,608)               (249,281)               (165,380)               (367,256)             (69,704,284)  
  Change in fair value of derivative liabilities (Note 10)          (2,107,844)            (4,142,004)               (230,557)            (3,783,290)               (4,086,793) (1)
  Loss on extinguishment of debt                       --                            --                            --                            --                (14,134,068)  
                                     
Net Loss Before Undernoted            (3,186,290)            (5,640,985)            (2,656,196)            (6,297,184)           (368,422,263)  
                                     
Minority Interest Share of Loss                       --                            --                            --                            --                    3,038,185  
                                     
Net Loss (Note 4)              (3,186,290)            (5,640,985)            (2,656,196)            (6,297,184)           (365,384,078)  
                                     
Preferred Stock Dividend (Note 9)               408,279                         --                    408,279                 102,297                 5,568,973  
                                     
Net Loss Available to Common Stockholders  $      (3,594,569)    $      (5,640,985)    $      (3,064,475)    $      (6,399,481)      $   (370,953,051)  
                                     
Basic and Diluted Net Loss Per                      
  Common Share (see Note 8)    $                 (.01)    $                 (.01)    $                 (.01)    $                 (.02)        
                                     
Weighted Average Number of Shares                      
  of Common Stock Outstanding                      
    - basic and diluted (Note 8)          627,522,138          386,422,031          611,449,549          375,366,195        
                                     
(1) Includes $5,981,403 as adjustment related to the adoption of FASB ASC Topic 815 in "Cumulative from November 2, 1995 (Date of Inception) to January 31, 2014" column.  See Note 10 - Derivative Liabilities.        

2
 

GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
                                 
                              Cumulative From  
                      For the Six Months    November 2, 1995  
                      Ended January 31,   (Date of Inception)  
                      2014   2013   to January 31, 2014  
Cash Flows From Operating Activities:                  
  Net income/(loss)          $    (2,656,196)    $    (6,297,184)    $  (365,384,078)  
  Adjustments to reconcile net loss to net cash used in operating activities:              
    Depreciation and amortization                    191,795              234,603            10,564,053  
    Minority interest share of loss                             --                          --               (3,038,185)  
    Reduction of notes receivable - common stock in exchange                
      for services rendered                             --                          --                    423,882  
    Write-off of uncollectible notes receivable - common stock                         --                          --                    391,103  
    Write-off of deferred offering costs                           --                          --                 3,406,196  
    Write-off of abandoned patents                           --                          --                 1,353,976  
    Gain on disposal of property and equipment               (188,869)             (993,867)            (3,217,504)  
    Loss on extinguishment of debt                           --                          --               14,134,069  
    Common stock issued as employee compensation                         --                          --                 4,011,938  
    Amortization of options and option modifications as stock compensation              262,871                19,697              4,511,851  
    Common stock issued for services rendered                  207,000              185,342            15,106,700  
    Amortization of prepaid services in conjunction with common stock issuance                       --                          --                    138,375  
    Non-cash compensation expense                           --                          --                      45,390  
    Stock options and warrants issued for services rendered                         --                          --                 7,956,723  
    Issuance of warrants as additional exercise right inducement                         --                          --               21,437,909  
    Preferred stock issued for services rendered                         --                          --                           100  
    Treasury stock redeemed for non-performance of services                         --                          --                  (138,000)  
    Amortization of deferred debt issuance costs and loan origination fees                       --                          --                 2,405,629  
    Amortization of discount on convertible debentures                         --                          --               38,345,592  
    Common stock issued for interest on convertible debentures & preferred stock              244,350              604,800              2,374,004  
    Interest on short-term advance                             --                          --                      22,190  
    Founders’ shares transferred for services rendered                         --                          --                    353,506  
    Fees in connection with refinancing of debt                           --                          --                    113,274  
    Warrant repricing costs                             --                          --                 3,198,604  
    Change in fair value of derivative liabilities                  230,557           3,783,290              4,086,793 (1)
    Changes in operating assets and liabilities (excluding the effects of acquisition):              
        Accounts receivable                             --                          --                    (15,047)  
        Miscellaneous receivables                             --                          --                      43,812  
        Inventory                             --                          --                    (20,091)  
        Other current assets                       (5,617)                39,179                 (64,368)  
        Accounts payable and accrued expenses                    51,665              449,789            15,199,161  
        Deferred revenue                       (1,181)               (25,300)                 217,869  
        Other, net                             --                          --                    110,317  
          Net Cash Used in Operating Activities              (1,663,625)          (1,999,651)        (221,924,257)  
                                 
Cash Flows From Investing Activities:                  
  Purchase of property and equipment                           --                          --               (4,809,439)  
  Proceeds from sale of property and equipment                883,780           1,578,779              7,601,113  
  Costs incurred for patents                     (34,674)               (40,234)            (2,953,668)  
  Change in restricted cash                             --                          --                    512,539  
  Proceeds from maturity of short term investments                         --                          --             195,242,918  
  Purchases of short-term investments                           --                          --           (195,242,918)  
  Cash received in conjunction with merger                           --                          --                      82,232  
  Advances to Antigen Express, Inc.                           --                          --                    (32,000)  
  Increase in officers’ loans receivable                            --                          --               (1,126,157)  
  Change in deposits                             --                          --                  (652,071)  
  Change in notes receivable - common stock                           --                          --                    (91,103)  
  Change in due from related parties                           --                          --               (2,222,390)  
  Other, net                               --                          --                      89,683  
          Net Cash Provided By (Used in) Investing Activities                849,106           1,538,545            (3,601,261)  
                                 
Cash Flows From Financing Activities:                  
  Proceeds from short-term advance                           --                          --                    325,179  
  Repayment of short-term advance                           --                          --                  (347,369)  
  Proceeds from issuance of long-term debt                           --                 866,403              6,396,335  
  Repayment of long-term debt                   (606,806)          (1,692,957)            (9,502,770)  
  Repayment of obligations under capital lease                         --                          --                    (83,002)  
  Change in due to related parties                             --                          --                    154,541  
  Proceeds from exercise of warrants, net               2,121,961              724,664            49,695,446  
  Proceeds from exercise of stock options                         526                       86              5,009,500  
  Proceeds from minority interest investment                           --                          --                 3,038,185  
  Proceeds from issuance of preferred stock, net                  750,000           1,450,000            19,670,000  
  Redemption of SVR preferred stock                           --                          --                         (100)  
  Proceeds from issuance of convertible debentures, net                         --                          --               40,704,930  
  Payment of costs associated with convertible debentures                         --                          --                  (722,750)  
  Repayments of convertible debentures                           --                          --               (5,142,424)  
  Purchase of treasury stock                             --                          --                  (483,869)  
  Proceeds from issuance of common stock, net                          --                          --             120,576,242  
  Purchase and retirement of common stock                           --                          --                  (497,522)  
          Net Cash Provided by Financing Activities             2,265,681           1,348,196          228,790,552  
                                 
Effect of Exchange Rates on Cash                     (18,904)               (10,687)               (123,822)  
                                 
Net Increase in Cash and Cash Equivalents             1,432,258              876,403              3,141,212  
                                 
Cash and Cash Equivalents, Beginning of Period             1,708,954              246,309                         --     
                                 
Cash and Cash Equivalents, End of Period        $     3,141,212    $     1,122,712    $        3,141,212  
                                 
(1) - includes $5,981,403 as adjustment related to the adoption of FASB ASC Topic 815 in "Cumulative from November 2, 1995 (Date of Inception) to January 31, 2014" column.  See Note 10 - Derivative Liabilities.  
                                 
Supplemental Disclosure of Cash Flow Information                
  Cash paid during the period for:                    
    Interest            $           35,541    $         143,333      
    Income taxes          $                --       $                --         

3
 

GENEREX BIOTECHNOLOGY CORPORATION AND SUBSIDIARIES

(A DEVELOPMENT STAGE COMPANY)

NOTES TO THE INTERIM CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

Note 1 – Basis of Presentation:

 

The accompanying unaudited interim consolidated financial statements (“interim statements”) have been prepared pursuant to the rules and regulations for reporting on Form 10-Q. Accordingly, certain information and disclosures required by generally accepted accounting principles for complete financial statements are not included herein. The interim statements should be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s latest Annual Report on Form 10-K. The results for the six months ended January 31, 2014 may not be indicative of the results for the entire year.

 

Interim statements are subject to possible adjustments in connection with the annual audit of the Company’s accounts for fiscal year 2014. In the Company’s opinion, all adjustments necessary for a fair presentation of these interim statements have been included and are of a normal and recurring nature.

 

The Company is a development stage company, which has a limited history of operations and limited revenue to date. This revenue has been comprised mainly of the sale of our confectionary products, although the Company has recognized $600,000 relating to upfront license fees for the signing of license and distribution agreements for Generex Oral-lyn™. Additionally, the Company has several product candidates that are in various research or early stages of pre-clinical and clinical development. There can be no assurance that the Company will be successful in obtaining regulatory clearance for the sale of existing or any future products or that any of the Company’s products will be commercially viable.

 

Going Concern

The accompanying interim statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The Company has experienced negative cash flows from operations since inception and has an accumulated deficit of approximately $371 million and a working capital deficiency of approximately $4.9 million at January 31, 2014. The Company has funded its activities to date almost exclusively from debt and equity financings, as well as the recent sales of non-essential real estate assets in fiscal 2012, fiscal 2013 and the first half of fiscal 2014 (see Note 11).

 

The Company will continue to require substantial funds to continue research and development, including pre-clinical studies and clinical trials of its product candidates, and to commence sales and marketing efforts, if the U.S. Food and Drug Administration or other regulatory approvals are obtained.  Management’s plans in order to meet its operating cash flow requirements include financing activities such as private placements of its common stock, preferred stock offerings, issuances of debt and convertible debt instruments.  Management will be limited in the financing activities that the Company undertakes in the near future as the securities purchase agreements that the Company entered into on June 17, 2013 and January 14, 2014 with certain investors prohibit the Company from (i) issuing additional equity securities until 60 days after the effective date of a registration statement covering the resale of the common stock issuable upon exercise of the warrants and conversion of the preferred stock sold in those transactions; and (ii) issuing additional debt or equity securities with variable conversion or exercise prices until June 17, 2014 and January 14, 2015, respectively. Management is also actively pursuing financial and strategic alternatives, including strategic investments and divestitures, industry collaboration activities and strategic partners.  Management has sold its non-essential real estate assets which were classified as Assets Held for Investment to augment its cash position.

 

These factors raise substantial doubt regarding the Company’s ability to continue as a going concern. There are no assurances that such additional funding will be achieved and that it will succeed in its future operations. The interim statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or amounts of liabilities that might be necessary should the Company be unable to continue in existence. The Company’s inability to obtain required funding in the near future or its inability to obtain funding on favorable terms will have a material adverse effect on its operations and strategic development plan for future growth. If the Company cannot successfully raise additional capital and implement its strategic development plan, its liquidity, financial condition and business prospects will be materially and adversely affected, and the Company may have to cease operations.

 

 

Note 2 – Effects of Recent Accounting Pronouncements:

 

Recently Adopted Accounting Pronouncements

In June 2011, the FASB issued guidance regarding the presentation of Comprehensive Income within financial statements. The guidance was effective for the Company’s annual fiscal period ended July 31, 2013. The adoption of this new accounting guidance did not have a material impact on the Company’s consolidated financial statements.

4
 

Note 3 – Stock-Based Compensation:

 

As of January 31, 2014, the Company had two stockholder-approved stock incentive plans under which shares and options exercisable for shares of common stock have been or may be granted to employees, directors, consultants and advisors. A total of 12,000,000 shares of common stock are reserved for issuance under the 2001 Stock Option Plan (the 2001 Plan) and 60,000,000 shares of common stock are reserved for issuance under the 2006 Stock Plan as amended (the 2006 Plan). At January 31, 2014, there were 1,353,916 and 6,417,242 shares of common stock reserved for future awards under the 2001 Plan and 2006 Plan, respectively. The Company issues new shares of common stock from the shares reserved under the respective Plans upon conversion or exercise of options and issuance of restricted shares.

 

The 2001 and 2006 Plans (the Plans) are administered by the Board of Directors (the Board). The Board is authorized to select from among eligible employees, directors, advisors and consultants those individuals to whom options are to be granted and to determine the number of shares to be subject to, and the terms and conditions of the options. The Board is also authorized to prescribe, amend and rescind terms relating to options granted under the Plans. Generally, the interpretation and construction of any provision of the Plans or any options granted hereunder is within the discretion of the Board.

 

The Plans provide that options may or may not be Incentive Stock Options (ISOs) within the meaning of Section 422 of the Internal Revenue Code. Only employees of the Company are eligible to receive ISOs, while employees and non-employee directors, advisors and consultants are eligible to receive options which are not ISOs, i.e. “Non-Qualified Options.” The options granted by the Board in connection with its adoption of the Plans were Non-Qualified Options. In addition, the 2006 Plan also provides for restricted stock grants.

The fair value of each option granted is estimated on the grant date using the Black-Scholes option pricing model or the value of the services provided, whichever is more readily determinable. The Black-Scholes option pricing model takes into account, as of the grant date, the exercise price and expected life of the option, the current price of the underlying stock and its expected volatility, expected dividends on the stock and the risk-free interest rate for the term of the option.

 

In the case of restricted stock grants under the 2006 Plan, fair market value of the shares is established as the market price on the date of the stock grant or the value of the services provided, whichever is more readily determinable.

 

The following is a summary of the common stock options granted, forfeited or expired and exercised under the Plans for the six months ended January 31, 2014:

 

       Weighted     
       Average     
       Exercise   Aggregate 
       Price   Intrinsic 
   Options   per Share   Value 
             
Outstanding, August 1, 2013   29,701,197   $0.080      
Add: Granted   8,879,499    0.001      
Less: Forfeited or expired   40,000    0.827      
Less: Exercised   526,306    0.001   21,052 
Outstanding, January 31, 2014   38,014,390   $$  0.062   $1,357,895 
Exercisable, January 31, 2014   38,014,390   $$ 0.062   $1,357,895 

 

The 38,014,390 outstanding options at January 31, 2014 had a weighted average remaining contractual term of 3.94 years.

 

The following is a summary of the non-vested common stock options granted, vested and forfeited under the Plans for the six months ended January 31, 2014:

 

       Weighted Average 
       Grant Date 
   Options   Fair Value 
         
Outstanding, August 1, 2013   60,000   $0.460 
Granted   8,879,499    0.029 
Vested   (8,939,499)   0.031 
Forfeited   0   n/a 
Outstanding, January 31, 2014   0   $n/a 

 

As of January 31, 2014, the Company did not have any unrecognized compensation cost related to non-vested share-based compensation arrangements granted under the Plans.

5
 

Note 4 – Comprehensive Income and Loss:

 

Comprehensive loss, which includes net loss and the change in the foreign currency translation account, for the six months ended January 31, 2014, was $2,641,950. Comprehensive loss, which includes net loss and the change in the foreign currency translation account, for the six months ended January 31, 2013, was $6,309,575.

 

Comprehensive loss, which includes net loss and the change in the foreign currency translation account, for the three months ended January 31, 2014, was $3,173,721. Comprehensive loss, which includes net loss and the change in the foreign currency translation account, for the three months ended January 31, 2013, was $5,640,896.

 

 

Note 5 – Accounts Payable and Accrued Expenses:

 

Accounts payable and accrued expenses consist of the following:

   January 31, 2014   July 31, 2013 
Accounts Payable and Accruals – General and Administrative  $3,282,163   $3,447,618 
Accounts Payable and Accruals – Research and Development   3,889,180    3,557,184 
Accounts Payable and Accruals – Selling and Marketing   326,929    328,629 
Accrued Make-whole Payments on Convertible Preferred Stock (see Note 9)  222,750    251,100 
Executive Compensation and Directors’ Fees Payable   170,657    76,703 
Total  $7,891,679   $7,661,234 

 

Note 6 – Pending Litigation:

 

In February 2001, a former business associate of the former Vice President of Research and Development (“VP”) of the Company and an entity known as Centrum Technologies Inc. (“CTI”) commenced an action in the Ontario Superior Court of Justice against the Company and the VP seeking, among other things, damages for alleged breaches of contract and tortious acts related to a business relationship between this former associate and the VP that ceased in July 1996. The plaintiffs’ statement of claim also seeks to enjoin the use, if any, by the Company of three patents allegedly owned by CTI. The three patents are entitled Liquid Formulations for Proteinic Pharmaceuticals, Vaccine Delivery System for Immunization, Using Biodegradable Polymer Microspheres, and Controlled Releases of Drugs or Hormones in Biodegradable Polymer Microspheres. It is the Company’s position that the buccal drug delivery technologies which are the subject matter of the Company’s research, development, and commercialization efforts, including Generex Oral-lyn™ and the RapidMist™ Diabetes Management System, do not make use of, are not derivative of, do not infringe upon, and are entirely different from the intellectual property identified in the plaintiffs’ statement of claim. On July 20, 2001, the Company filed a preliminary motion to dismiss the action of CTI as a nonexistent entity or, alternatively, to stay such action on the grounds of want of authority of such entity to commence the action. The plaintiffs brought a cross motion to amend the statement of claim to substitute Centrum Biotechnologies, Inc. (“CBI”) for CTI. CBI is a corporation of which 50 percent of the shares are owned by the former business associate and the remaining 50 percent are owned by the Company. Consequently, the shareholders of CBI are in a deadlock. The court granted the Company’s motion to dismiss the action of CTI and denied the plaintiffs’ cross motion without prejudice to the former business associate to seek leave to bring a derivative action in the name of or on behalf of CBI. The former business associate subsequently filed an application with the Ontario Superior Court of Justice for an order granting him leave to file an action in the name of and on behalf of CBI against the VP and the Company. The Company opposed the application. In September 2003, the Ontario Superior Court of Justice granted the request and issued an order giving the former business associate leave to file an action in the name of and on behalf of CBI against the VP and the Company. A statement of claim was served in July 2004. The Company is not able to predict the ultimate outcome of this legal proceeding at the present time or to estimate an amount or range of potential loss, if any, from this legal proceeding.

6
 

On May 20, 2011, Ms. Perri filed a statement of claim (subsequently amended) in the Ontario Superior Court of Justice, naming as defendants the Company and certain directors of the Company, Mr. Barratt, Ms. Masterson, Mr. McGee, and Mr. Fletcher. In this action, Ms. Perri has alleged that defendants engaged in discrimination, harassment, bad faith and infliction of mental distress in connection with the termination of her employment with the Company. Ms. Perri is seeking damages in this action in excess of $7,000,000 for, among other things, breach of contract, breach of fiduciary duty, violations of the Ontario Human Rights Code and aggravated and punitive damages. On September 20, 2011, the defendants filed a statement of defense and counterclaim, also naming Time Release Corp., Khazak Group Consulting Corp., and David Khazak, C.A. as defendants by counterclaim, and seeking damages of approximately $2.3 million in funds that the defendants allege Ms. Perri wrongly caused the Company to pay to third parties in varying amounts over several years and an accounting of certain third-party payments, plus interests and costs. The factual basis for the counterclaim involves payments made by the Company to third parties believed to be related to Ms. Perri. The Company intends to defend this action and pursue its counterclaim vigorously and is not able to predict the ultimate outcome of this legal proceeding at the present time or to estimate an amount or range of potential loss, if any, from this legal proceeding.

 

On June 1, 2011, Golden Bull Estates Ltd. filed a claim (subsequently amended) in the Ontario Superior Court of Justice, naming the Company, 1097346 Ontario, Inc. and Generex Pharmaceuticals, Inc. as defendants. The plaintiff, Golden Bull Estates, is controlled by Ms. Perri. The plaintiff alleges damages in the amount of $550,000 for breach of contract, $50,000 for punitive damages, plus interest and costs. The plaintiff’s claims relate to an alleged contract between the plaintiff and the Company for property management services for certain Ontario properties owned by the Company. The Company terminated the plaintiff’s property management services in April 2011. Following the close of pleadings, the Company served a motion for summary judgment. The plaintiff responded by amending its statement of claim to include a claim to the Company’s interest in certain of its real estate holdings. The plaintiff moved for leave to issue and register a Certificate of Pending Litigation in respect of this real estate. The motion was not successful in respect of any current real estate holdings of the Company. The Company is not able to predict the ultimate outcome of this legal proceeding at the present time or to estimate an amount or range of potential loss, if any, from this legal proceeding.

 

In August 2011, the estate of Antonio Perri, the late father of Ms. Perri, commenced an action against Generex Pharmaceuticals, Inc., the law firm of Brans, Lehun, Baldwin LLP and William Lehun in the Ontario Superior Court of Justice claiming that the estate is entitled to the proceeds of sale (approximately $1,730,000) received by the Company on its sale of two properties to Golden Bull Estates Ltd., a company controlled by Ms. Perri. The suit alleges that no consideration was received when the Company purchased the two properties from Antonio Perri in 1998. The Company has responded to this statement of claim and intends to defend this action vigorously. The Company is not able to predict the ultimate outcome of this legal proceeding at the present time or to estimate an amount or range of potential loss, if any, from this legal proceeding.

 

In December 2011, a vendor of the Company commenced an action against the Company and its subsidiary, Generex Pharmaceuticals, Inc., in the Ontario Superior Court of Justice claiming damages for unpaid invoices including interest in the amount of $429,000, in addition to costs and further interest.  The Company responded to this statement of claim and also asserted a counterclaim in the proceeding for $200,000 arising from the vendor’s breach of contract and detinue, together with interest and costs. On November 16, 2012, the parties agreed to settle this action and the Company has agreed to pay the plaintiff $125,000, following the spinout of its subsidiary Antigen, from the proceeds of any public or private financing related to Antigen subsequent to such spinout.  Each party agreed to execute mutual releases to the claim and counterclaim to be held in trust by each party’s counsel until payment of the settlement amount.  Following payment to the plaintiff, the parties agree that a Consent Dismissal Order without costs will be filed with the court.  If the Company fails to make the payment following completion of any post-spinout financing related to Antigen or any other subsidiaries, the Plaintiffs may take out a judgment in the amount of the claim plus interest of 3% per annum and costs fixed at $25,000.

 

The Company is involved in certain other legal proceedings in addition to those specifically described herein. Subject to the uncertainty inherent in all litigation, the Company does not believe at the present time that the resolution of any of these legal proceedings is likely to have a material adverse effect on the Company’s consolidated financial position, operations or cash flows.

 

With respect to all litigation, as additional information concerning the estimates used by the Company becomes known, the Company reassesses its position both with respect to accrued liabilities and other potential exposures.

 

 

Note 7 – Commitments:

 

On December 7, 2009, the Company entered into a long-term agreement with sanofi-aventis Deutschland GmbH (“sanofi”). Under this agreement, sanofi will manufacture and supply recombinant human insulin to the Company in the territories specified in the agreement. Through this agreement, the Company will procure recombinant human insulin crystals for use in the production of Generex Oral-lyn™. The terms of the supply agreement required the Company to make certain minimum purchases of insulin from sanofi through the period ended December 31, 2011. To date, the Company has not met the minimum purchase commitments under this agreement. After December 31, 2011, sanofi may terminate the agreement due to the Company’s failure to meet such purchase commitments. Upon termination, the Company would be obligated to pay sanofi for all materials and components that it has acquired or ordered to manufacture insulin based on the Company’s forecasts or minimum purchase commitments, all related work-in-progress (at cost) and all finished insulin in inventory. To date, the Company has not provided forecasts to sanofi for the purchase of insulin and sanofi has not terminated the agreement.

7
 

Note 8 – Net Loss Per Share (“EPS”):

 

Basic EPS and Diluted EPS for the three and six-month periods ended January 31, 2014 have been computed by dividing the net loss available to common stockholders for the period by the weighted average shares outstanding during each period. All outstanding stock options, non-vested restricted stock, warrants and common stock underlying convertible preferred stock, representing 259,678,976 incremental shares at January 31, 2014, have been excluded from the respective computations of Diluted EPS as they are anti-dilutive, due to the loss generated during that period.

 

Basic EPS and Diluted EPS for the three and six-month periods ended January 31, 2013 have been computed by dividing the net loss available to common stockholders for the period by the weighted average shares outstanding during each period. All outstanding stock options, non-vested restricted stock, warrants and common stock underlying convertible preferred stock, representing 270,883,228 incremental shares at January 31, 2013, have been excluded from the respective computations of Diluted EPS as they are anti-dilutive, due to the loss generated during that period.

 

 

Note 9 – Stockholders’ Deficiency:

 

Common Stock

During the six months ended January 31, 2014, the Company issued or committed to issue 1,233,334 shares of common stock to various consultants for services rendered in the amount of $77,000. The shares were valued at a range of prices from $0.03 per share to $0.15 per share based on the quoted market price of the Company’s common stock on the dates of the issuances or commitment to issue

 

During the six months ended January 31, 2014, the Company issued or committed to issue 4,333,333 shares of common stock valued at $130,000 as employee compensation. The shares were valued at $0.03 per share based on the quoted market price of the Company’s common stock on the dates of the issuances or commitment to issue.

 

During the six months ended January 31, 2014, the Company issued 30,166,666 shares of common stock in conjunction with the conversion of 905 shares of the Series E 9% Convertible Preferred Stock and 8,730,195 shares of common stock as “make-whole” dividend payments on the Series E 9% Convertible Preferred Stock.

 

During the six months ended January 31, 2014, the Company issued 70,732,022 shares of common stock upon the exercise of warrants which had an exercise price of $0.03 per share. The Company received cash proceeds of $2,121,961 upon the exercise of these warrants and an additional value of $2,039,599 was transferred from the value of the derivative warrant liability to additional paid in capital upon such warrant exercises.

 

Stock option expense of $5,365 related to the amortization of executive and employee options granted in October 2009, was charged to the interim consolidated statements of operations during the six months ended January 31, 2014, in addition to stock option expense related to options granted to executives, directors and employees in exchange for repayment of deferred salaries in the amount of $257,505.

 

During the six months ended January 31, 2014, the Company received cash proceeds of $526 from exercises of options at $0.001 per share.  The Company issued 526,306 shares of common stock as a result of these exercises.

 

During the six months ended January 31, 2014, the Company recognized an increase in equity of $237,566 related to the partial exercise of the additional investment rights related to the Company’s June 2013 convertible preferred stock financing.

8
 

The stockholders’ deficiency transactions for the six months ended January 31, 2014 as described above are summarized below:

 

 

       Additional   Change to 
   Common Stock   Paid-In   Stockholders 
   Shares   Amount   Capital   Equity 
                 
Issuance of common stock on conversion of convertible preferred stock   30,166,666   $30,167   $(30,167)  $ 
Issuance of common stock as make-whole payments on convertible preferred stock   8,730,195    8,730    235,620    244,350 
Issuance of common stock for services   1,233,334    1,233    75,767    77,000 
Issuance of common stock as employee compensation   4,333,333    4,333    125,667    130,000 
Issuance of common stock for cash warrant exercises   70,732,022    70,731    4,090,828    4,161,559 
Issuance of options in lieu of deferred salary           257,505    257,505 
Exercise of employee stock options   526,306    526        526 
Partial exercise of additional investment rights           237,566    237,566 
Amortization of stock options as employee compensation           5,365    5,365 
Total   115,721,856   $115,720   $4,998,151   $ 5,113,871 

 

Warrants

The following is a summary of warrants issued, forfeited or expired and exercised for the six months ended January 31, 2014:

 

   Warrants 
Outstanding, August 1, 2013   238,229,939 
Plus: Issued   26,666,668 
Less: Exercised   70,732,022 
Outstanding, January 31, 2014   194,164,585 

 

The outstanding warrants at January 31, 2014 have a weighted average exercise price of $0.10 per share and have a weighted average remaining life of 3.0 years.

 

As of January 31, 2014, the Company has 69,516,756 warrants with a current exercise price of $0.03 and an expiry date of March 31, 2016, 27,272,720 warrants with a current exercise price of $0.03 and an expiry date of September 30, 2016, 5,675,227 warrants with a current exercise price of $0.03 and an expiry date of February 1, 2017, 4,999,999 warrants with a current exercise price of $0.03 and an expiry date of August 10, 2017, 8,324,144 warrants with a current exercise price of $0.03 and an expiry date of December 12, 2017, 34,166,669 warrants with a current exercise price of $0.03 and an expiry date of June 17, 2018 and 26,666,668 warrants with a current exercise price of $0.03 and an expiry date of January 15, 2019 (176,622,183 warrants in total), which have price protection provisions that allow for the reduction in the current exercise price upon the occurrence of certain events, including the Company’s issuance of common stock or securities convertible into or exercisable for common stock, such as options and warrants, at a price per share less than the exercise price then in effect. For instance, if the Company issues shares of its common stock or options exercisable for or securities convertible into common stock at an effective price per share of common stock less than the exercise price then in effect, the exercise price will be reduced to the effective price of the new issuance. Simultaneously with any reduction to the exercise price, the number of shares of common stock that may be purchased upon exercise of each of these warrants shall be increased proportionately, so that after such adjustment the aggregate exercise price payable for the adjusted number of warrants shall be the same as the aggregate exercise price in effect immediately prior to such adjustment.

 

The Company’s issuance of the following securities will not trigger the price protection provisions of the warrants described above that were issued in connection with the March 2008 private placement: (a) shares of common stock or standard options to the Company’s directors, officers, employees or consultants pursuant to a board-approved equity compensation program or other contract or arrangement (up to an aggregate amount of 5,608,926, representing 5% of the common stock issued and outstanding immediately prior to March 31, 2008); (b) shares of common stock issued upon the conversion or exercise of any security, right or other instrument convertible or exchangeable into common stock (or securities exchangeable into common stock) issued prior to March 31, 2008; (c) the shares of common stock issued upon exercise of the warrants issued in March 2008; and (d) shares of common stock and warrants in connection with strategic alliances, acquisitions, mergers, and strategic partnerships, the primary purpose of which is not to raise capital, and which are approved in good faith by the Company’s board of directors (up to an aggregate number of 11,217,852, representing 10% of the shares of common stock issued and outstanding immediately prior to March 31, 2008). 

9
 

The Company’s issuance of the following securities will not trigger the price protection provisions of the warrants issued on February 2, 2012: (I)(a) shares of common stock or options to employees, officers or directors of the Company pursuant to any stock or option plan duly adopted for such purpose, by a majority of the non-employee members of the Board of Directors or a majority of the members of a committee of non-employee directors established for such purpose, (b) shares of common stock issued to the vendors identified in Securities Purchase Agreement dated January 31, 2012, in the periodic amounts set forth therein, (c) securities upon the exercise or exchange of or conversion of any Securities issued under the Securities Purchase Agreements dated July 8, 2011 and January 31, 2012 and/or other securities exercisable or exchangeable for or convertible into shares of common stock issued and outstanding on February 2, 2012, provided that such securities have not been amended since the date of this Agreement to increase the number of such securities or to decrease the exercise price, exchange price or conversion price of such securities, and (d) securities issued pursuant to acquisitions or strategic transactions approved by a majority of the disinterested directors of the Company, provided that any such issuance shall only be to a person (or to the equityholders of a person) which is, itself or through its subsidiaries, an operating company or an owner of an asset in a business synergistic with the business of the Company and shall provide to the Company additional benefits in addition to the investment of funds, but shall not include a transaction in which the Company is issuing securities primarily for the purpose of raising capital or to an entity whose primary business is investing in securities.

 

The Company’s issuance of the following securities will not trigger the price protection provisions of the warrants issued on August 10, 2012: (I)(a) shares of common stock or options to employees, officers or directors of the Company pursuant to any stock or option plan duly adopted for such purpose, by a majority of the non-employee members of the Board of Directors or a majority of the members of a committee of non-employee directors established for such purpose, (b) shares of common stock issued to the vendors identified in Securities Purchase Agreement dated August 8, 2012, in the periodic amounts set forth therein, (c) securities upon the exercise or exchange of or conversion of any Securities issued under the Securities Purchase Agreements dated July 8, 2011, January 31, 2012 and August 8, 2012 and/or other securities exercisable or exchangeable for or convertible into shares of common stock issued and outstanding on August 8, 2012, provided that such securities have not been amended since the date of this Agreement to increase the number of such securities or to decrease the exercise price, exchange price or conversion price of such securities, and (d) securities issued pursuant to acquisitions or strategic transactions approved by a majority of the disinterested directors of the Company, provided that any such issuance shall only be to a person (or to the equityholders of a person) which is, itself or through its subsidiaries, an operating company or an owner of an asset in a business synergistic with the business of the Company and shall provide to the Company additional benefits in addition to the investment of funds, but shall not include a transaction in which the Company is issuing securities primarily for the purpose of raising capital or to an entity whose primary business is investing in securities.

 

The Company’s issuance of the following securities will not trigger the price protection provisions of the warrants issued on December 10, 2012: (I)(a) shares of common stock or options to employees, officers or directors of the Company pursuant to any stock or option plan duly adopted for such purpose, by a majority of the non-employee members of the Board of Directors or a majority of the members of a committee of non-employee directors established for such purpose, (b) shares of common stock issued to the vendors identified in Securities Purchase Agreement dated December 10, 2012, in the periodic amounts set forth therein, (c) securities upon the exercise or exchange of or conversion of any Securities issued under the Securities Purchase Agreements dated July 8, 2011, January 31, 2012, August 8, 2012 and December 10, 2012 and/or other securities exercisable or exchangeable for or convertible into shares of common stock issued and outstanding on December 10, 2012, provided that such securities have not been amended since the date of this Agreement to increase the number of such securities or to decrease the exercise price, exchange price or conversion price of such securities, and (d) securities issued pursuant to acquisitions or strategic transactions approved by a majority of the disinterested directors of the Company, provided that any such issuance shall only be to a person (or to the equityholders of a person) which is, itself or through its subsidiaries, an operating company or an owner of an asset in a business synergistic with the business of the Company and shall provide to the Company additional benefits in addition to the investment of funds, but shall not include a transaction in which the Company is issuing securities primarily for the purpose of raising capital or to an entity whose primary business is investing in securities.

 

10
 

The Company’s issuance of the following securities will not trigger the price protection provisions of the warrants issued on June 17, 2013: (I)(a) shares of common stock or options to employees, officers or directors of the Company pursuant to any stock or option plan duly adopted for such purpose, by a majority of the non-employee members of the Board of Directors or a majority of the members of a committee of non-employee directors established for such purpose, (b) shares of common stock issued to the vendors identified in Securities Purchase Agreement dated June 17, 2013, in the periodic amounts set forth therein, (c) securities upon the exercise or exchange of or conversion of any Securities issued under the Securities Purchase Agreements dated July 8, 2011, January 31, 2012, August 8, 2012, December 10, 2012 and June 17, 2013 and/or other securities exercisable or exchangeable for or convertible into shares of common stock issued and outstanding on June 17, 2013, provided that such securities have not been amended since the date of this Agreement to increase the number of such securities or to decrease the exercise price, exchange price or conversion price of such securities, and (d) securities issued pursuant to acquisitions or strategic transactions approved by a majority of the disinterested directors of the Company, provided that any such issuance shall only be to a person (or to the equityholders of a person) which is, itself or through its subsidiaries, an operating company or an owner of an asset in a business synergistic with the business of the Company and shall provide to the Company additional benefits in addition to the investment of funds, but shall not include a transaction in which the Company is issuing securities primarily for the purpose of raising capital or to an entity whose primary business is investing in securities.

 

The Company’s issuance of the following securities will not trigger the price protection provisions of the warrants issued on January 15, 2014: (I)(a) shares of common stock or options to employees, officers or directors of the Company pursuant to any stock or option plan duly adopted for such purpose, by a majority of the non-employee members of the Board of Directors or a majority of the members of a committee of non-employee directors established for such purpose, (b) shares of common stock issued to the vendors identified in Securities Purchase Agreement dated January 15, 2014, in the periodic amounts set forth therein, (c) securities upon the exercise or exchange of or conversion of any Securities issued under the Securities Purchase Agreements dated January 31, 2012, August 8, 2012, December 10, 2012, June 17, 2013 and January 15, 2014 and/or other securities exercisable or exchangeable for or convertible into shares of common stock issued and outstanding on January 15, 2014, provided that such securities have not been amended since the date of this Agreement to increase the number of such securities or to decrease the exercise price, exchange price or conversion price of such securities, and (d) securities issued pursuant to acquisitions or strategic transactions approved by a majority of the disinterested directors of the Company, provided that any such issuance shall only be to a person (or to the equityholders of a person) which is, itself or through its subsidiaries, an operating company or an owner of an asset in a business synergistic with the business of the Company and shall provide to the Company additional benefits in addition to the investment of funds, but shall not include a transaction in which the Company is issuing securities primarily for the purpose of raising capital or to an entity whose primary business is investing in securities.

 

The Company accounts for the warrants with price protection provisions in accordance with FASB ASC Topic 815 as described in Note 10 - Derivative Liabilities below. As of January 31, 2014, there were a total of 176,622,183 warrants with an estimated fair value of $5,259,929, which are identified on the interim consolidated balance sheets under the caption “Derivative Warrant Liability”.

 

Series A 9% Convertible Preferred Stock

The Company has authorized 5,500 shares of Series A 9% Convertible Preferred Stock with a stated value of one thousand ($1,000) per share. Pursuant to a securities purchase agreement dated July 8, 2011, the Company sold an aggregate of 2,575 shares of convertible preferred stock, as well as accompanying warrants to purchase 17,166,666 shares of common stocks. An aggregate of 17,166,666 shares of the Company’s common stock were issuable upon conversion of the convertible preferred stock which was issued at the initial closing. As of the end of the Company’s fiscal year 2012, all of the issued Series A 9% Convertible Preferred Stock had been converted to common stock. There were 17,166,666 shares of common stock issued upon the conversion of the Series A convertible preferred stock and 6,129,666 shares of common stock issued as “make-whole payments” on such conversions.

 

Series B 9% Convertible Preferred Stock

The Company has authorized 2,000 shares of Series B 9% Convertible Preferred Stock with a stated value of one thousand ($1,000) per share. Pursuant to a securities purchase agreement dated January 31, 2012, the Company sold an aggregate of 2,000 shares of Series B convertible preferred stock, as well as accompanying warrants to purchase 13,333,333 shares of common stocks. An aggregate of 13,333,333 shares of the Company’s common stock were issuable upon conversion of the Series B convertible preferred stock which was issued at the initial closing. On December 10, 2012, the triggering of the price protection features of the Series B convertible preferred stock resulted in a decrease of the conversion price from $0.08 to $0.03 per share and a corresponding increase in the number of common shares underlying the remaining 792 shares of Series B convertible preferred stock as of December 10, 2012 from 9,897,500 to 26,393,333. As of the end of the Company’s fiscal year 2013, all of the issued Series B 9% Convertible Preferred Stock had been converted to common stock. There were 38,520,832 shares of common stock issued upon the conversion of the Series B convertible preferred stock and 14,819,679 shares of common stock issued as “make-whole payments” on such conversions.

11
 

Series C 9% Convertible Preferred Stock

The Company has authorized 750 shares of Series C 9% Convertible Preferred Stock with a stated value of one thousand ($1,000) per share. Pursuant to a securities purchase agreement dated August 8, 2012, the Company sold an aggregate of 750 shares of Series C convertible preferred stock, as well as accompanying warrants to purchase 9,375,000 shares of common stocks. An aggregate of 9,375,000 shares of the Company’s common stock were issuable upon conversion of the Series C convertible preferred stock which was issued at the initial closing. On December 10, 2012, the triggering of the price protection features of the Series C convertible preferred stock resulted in a decrease of the conversion price from $0.08 to $0.03 per share and a corresponding increase in the number of common shares underlying the 650 shares of Series C convertible preferred stock as of December 10, 2012 from 8,125,000 to 21,666,666. As of the end of the Company’s fiscal year 2013, all of the issued Series C 9% Convertible Preferred Stock had been converted to common stock. There were 22,916,665 shares of common stock issued upon the conversion of the Series C convertible preferred stock and 6,664,863 shares of common stock issued as “make-whole payments” on such conversions.

 

Series D 9% Convertible Preferred Stock

The Company has authorized 750 shares of Series D 9% Convertible Preferred Stock with a stated value of one thousand ($1,000) per share. Pursuant to a securities purchase agreement dated December 10, 2012, the Company sold an aggregate of 750 shares of Series D convertible preferred stock, as well as accompanying warrants to purchase 24,999,999 shares of common stocks. An aggregate of 24,999,999 shares of the Company’s common stock were issuable upon conversion of the Series D convertible preferred stock which was issued at the initial closing. As of the end of the Company’s fiscal year 2013, all of the Series D convertible preferred stock had been converted to common stock. There were 24,999,999 shares of common stock issued upon the conversion of the Series D convertible preferred stock and 7,825,191 shares of common stock issued as “make-whole payments” on such conversions.

 

Series E 9% Convertible Preferred Stock

The Company has authorized 2,450 shares of Series E 9% Convertible Preferred Stock with a stated value of one thousand ($1,000) per share. Pursuant to a securities purchase agreement dated June 17, 2013, the Company sold an aggregate of 1,225 shares of Series E convertible preferred stock, as well as accompanying warrants to purchase 40,833,335 shares of common stocks. An aggregate of 40,833,335 shares of the Company’s common stock are issuable upon conversion of the Series E convertible preferred stock which was issued at the initial closing on June 17, 2013. Pursuant to a securities purchase agreement dated January 14, 2014, the Company sold an aggregate of 800 shares of Series E convertible preferred stock, as well as accompanying warrants to purchase 26,666,668 shares of common stock. An aggregate of 26,666,668 shares of the Company’s common stock are issuable upon conversion of the Series E convertible preferred stock which was issued at the closing on January 15, 2014.

 

Subject to certain ownership limitations, the convertible preferred stock is convertible at the option of the holder at any time into shares of the Company’s common stock at an effective conversion price of $0.03 per share, and will accrue a 9% dividend until June 17, 2016 and, beginning on June 17, 2016 and on each one year anniversary thereafter, such dividend rate will increase by an additional 3%. The dividend is payable quarterly on September 30, December 31, March 31 and June 30, beginning on June 30, 2013 and on each conversion date in cash, or at the Company’s option, in shares of common stock. In the event that the convertible preferred stock is converted prior to June 17, 2016, the Company will pay the holder of the converted preferred stock an amount equal to $270 per $1,000 of stated value of the convertible preferred stock, less the amount of all prior quarterly dividends paid on such converted preferred stock before the relevant conversion date. Such “make-whole payment” may be made in cash or, at the Company’s option, in shares of its common stock. In addition, beginning June 17, 2016, the Company will pay dividends on shares of preferred stock equal to (on an as-if-converted-to-common-stock basis) and in the same form as dividends (other than dividends in the form of common stock) actually paid on shares of the common stock when, and if such dividends are paid. The Company will incur a late fee of 18% per annum on unpaid dividends.

 

The conversion price of the convertible preferred stock is subject to adjustment in the case of stock splits, stock dividends, combinations of shares, similar recapitalization transactions and certain pro-rata distributions to common stockholders. The conversion price will also be adjusted if the Company sells or grants any shares of common stock or securities convertible into, or rights to acquire, common stock at an effective price per share that is lower than the then conversion price, except in the event of certain exempt issuances. In addition, the holders of convertible preferred stock will be entitled to receive any securities or rights to acquire securities or property granted or issued by the Company pro rata to the holders of its common stock to the same extent as if such holders had converted all of their shares of convertible preferred stock. In the event of a fundamental transaction, such as a merger, consolidation, sale of substantially all assets and similar reorganizations or recapitalizations, the holders of convertible preferred stock will be entitled to receive, upon conversion of their shares, any securities or other consideration received by the holders of the Company’s common stock pursuant to the fundamental transaction.

12
 

The Company may become obligated to redeem the convertible preferred stock in cash upon the occurrence of certain triggering events, including the failure to provide an effective registration statement covering shares of common stock issuable upon conversion of the convertible preferred stock, material breach of certain contractual obligations to the holders of the convertible preferred stock, the occurrence of a change in control of the Company, the occurrence of certain insolvency events relating to the Company, or the failure of the Company’s common stock to continue to be listed or quoted for trading on one or more specified United States securities exchanges or regulated quotation services. Upon the occurrence of certain triggering events, each holder of convertible preferred stock will have the option to redeem such holder’s shares of convertible preferred stock for a redemption price payable in shares of common stock or receive an increased dividend rate of 18% on all of such holder’s outstanding convertible preferred stock.

 

In conjunction with the issuance of the Series E convertible preferred stock in June 2013 and January 2014, the Company also issued 40,833,335 and 26,666,668 warrants, respectively to the investors. Subject to certain ownership limitations, the warrants will be exercisable at any time after their respective dates of issuance and on or before the fifth-year anniversary thereafter at an exercise price of $0.03 per share of common stock. The exercise price of the warrants and, in some cases, the number of shares issuable upon exercise, are subject to adjustment in the case of stock splits, stock dividends, combinations of shares, similar recapitalization transactions and certain pro-rata distributions to common stockholders. The exercise price and number of shares of common stock issuable upon exercise will also be adjusted if the Company sells or grants any shares of common stock or securities convertible into, or rights to acquire, common stock at an effective price per share that is lower than the then exercise price, except in the event of certain exempt issuances. In addition, the warrant holders will be entitled to receive any securities or rights to acquire securities or property granted or issued by the Company pro rata to the holders of its common stock to the same extent as if such holders had exercised all of their warrants. In the event of a fundamental transaction, such as a merger, consolidation, sale of substantially all assets and similar reorganizations or recapitalizations, the warrant holders will be entitled to receive, upon exercise of their warrants, any securities or other consideration received by the holders of the Company’s common stock pursuant to the fundamental transaction. These warrants have been classified as derivative liabilities and are described further in Note 10 – Derivative Liabilities.

 

In addition, until the first anniversary date of the initial securities purchase agreement, each investor may, in its sole determination, elect to purchase, severally and not jointly with the other investors, in one or more purchases, in the ratio of such investor's original subscription amount to the original aggregate subscription amount of all investors, additional units consisting of convertible preferred stock and warrants at a purchase price of $1,000 per unit with an aggregate subscription amount thereof of up to $1,225,000, which units will have terms identical to the units of convertible preferred stock and warrants issued in connection with the June 2013 closing. These additional investment rights of the investors have been classified as derivative liabilities and are described further in Note 10 – Derivative Liabilities. On January 15, 2014, certain investors exercised 800 of the 1,225 shares of convertible preferred stock and related warrants available under the additional investment rights. Certain investors will continue to have rights to purchase up to 425 shares of convertible preferred stock and related warrants until June 17, 2014.

 

As of January 31, 2014, 1,200 of the Series E convertible preferred stock had been converted to common stock. There were 40,000,000 shares of common stock issued upon the conversion of the Series E convertible preferred stock and 11,385,194 shares of common stock issued as “make-whole payments” on such conversions.

 

Accounting for proceeds from the Series E convertible preferred stock financing

 

The net cash proceeds from the initial Series E convertible preferred stock financing in June 2013 were $1,165,000. The proceeds from the financing were allocated first to the warrants that were issued in the financing, second to the additional investment rights associated with the financing and third to the make whole payments. As the assigned fair values were greater than the net cash proceeds from the transaction, the excess was treated as a “deemed dividend” for accounting purposes and was reported on the Company’s consolidated statement of operations for the year ended July 31, 2013 under the caption “Preferred Stock Dividend”. The calculation methodologies for the fair values of the derivative warrant liability and the derivative additional investment rights liability are described in Note 10 – Derivative Liabilities below. The fair values assigned to each component and the calculation of the amount of the deemed dividend are as follows:

 

     Accounting allocation of initial proceeds    
  Net proceeds          $   1,165,000
  Derivative warrant liability fair value         (1,189,744)
  Derivative additional investment rights fair value    (1,264,683)
  Make whole payments liability  (330,750)
  Deemed dividend   $ (1,620,177)

 

13
 

The initial “make-whole payments” of $330,750 on the Series E convertible preferred stock were accrued as of the date of the financing and the remaining balance of $6,750 (after conversions) is included in Accounts Payable and Accrued Expenses (see Note 5) at January 31, 2014.

 

The net cash proceeds from the Series E convertible preferred stock financing in January 2014 were $750,000. The proceeds from the financing were allocated first to the warrants that were issued in the financing and second to the make whole payments. As the assigned fair values were greater than the net cash proceeds from the transaction, the excess was treated as a “deemed dividend” for accounting purposes and was reported on the Company’s consolidated statement of operations for the quarter ended January 31, 2014 under the caption “Preferred Stock Dividend”. The calculation methodologies for the fair values of the derivative warrant liability and the derivative additional investment rights liability are described in Note 10 – Derivative Liabilities below. The fair values assigned to each component and the calculation of the amount of the deemed dividend are as follows:

 

     Accounting allocation of initial proceeds    
  Net proceeds          $ 750,000
  Derivative warrant liability fair value         (942,279)
  Make whole payments liability  (216,000)
  Deemed dividend   $(408,279)

 

The initial “make-whole payments” of $216,000 on the Series E convertible preferred stock were accrued as of the date of the financing and that balance is included in Accounts Payable and Accrued Expenses (see Note 5) at January 31, 2014.

 

 

Note 10 – Derivative Liabilities:

 

Derivative warrant liability

The Company has warrants outstanding with price protection provisions that allow for the reduction in the exercise price of the warrants in the event the Company subsequently issues stock or securities convertible into stock at a price lower than the exercise price of the warrants. Simultaneously with any reduction to the exercise price, the number of shares of common stock that may be purchased upon exercise of each of these warrants shall be increased or decreased proportionately, so that after such adjustment the aggregate exercise price payable for the adjusted number of warrants shall be the same as the aggregate exercise price in effect immediately prior to such adjustment.

 

Accounting for Derivative Warrant Liability

The Company’s derivative instruments have been measured at fair value at January 31, 2014 and July 31, 2013 using the binomial lattice model. The Company recognizes all of its warrants with price protection in its consolidated balance sheets as a liability. The liability is revalued at each reporting period and changes in fair value are recognized currently in the consolidated statements of operations. The initial recognition and subsequent changes in fair value of the derivative warrant liability have no effect on the Company’s consolidated cash flows.

 

The derivative warrants outstanding at January 31, 2014 are all currently exercisable with a weighted-average remaining life of 3.2 years.

 

The revaluation of the warrants at ends of the respective reporting periods resulted in the recognition of a loss of $230,557 within the Company’s consolidated statements of operations for the six months ended January 31, 2014 and a loss of $3,783,290 for the six months ended January 31, 2013, which is included in the consolidated statement of operations under the caption “Change in fair value of derivative liabilities”. The fair value of the warrants at January 31, 2014 and July 31, 2013 was $5,259,929 and $5,234,293, respectively, which is reported on the consolidated balance sheets under the caption “Derivative Warrant Liability”. The following summarizes the changes in the value of the derivative warrant liability from August 1, 2012 until January 31, 2014:

              Value No. of Warrants
Balance at August 1, 2012 – Derivative warrant liability $   4,081,627 55,148,530
Additional warrants issued in August 2012 financing   624,797   9,375,000
Additional warrants issued in December 2012 financing   762,355 24,999,999
Additional warrants issued in June 2013 financing   1,189,744  40,833,335
Additional warrants from price protection features of existing warrants   7,484,550   236,219,094
Exercise of warrants (5,629,130) (145,888,421)
Decrease in fair value of derivative warrant liability (3,279,650)                   n/a
Balance at July 31, 2013 – Derivative warrant liability  $   5,234,293   220,687,537
Exercise of warrants (2,039,599) (70,732,022)
Additional warrants issued in January 2014 financing   942,279 26,666,668
Increase in fair value of derivative warrant liability    1,122,959                  n/a
Balance at January 31, 2014 – Derivative warrant liability  $  5,259,929   176,622,183

 

14
 

Fair Value Assumptions Used in Accounting for Derivative Warrant Liability

The Company has determined its derivative warrant liability to be a Level 2 fair value measurement and has used the binominal lattice pricing model to calculate the fair value as of January 31, 2014 and July 31, 2013. The binomial lattice model requires six basic data inputs: the exercise or strike price, time to expiration, the risk free interest rate, the current stock price, the estimated volatility of the stock price in the future, and the dividend rate. Because the warrants contain the price protection feature, the probability that the exercise price of the warrants would decrease as the stock price decreased was incorporated into the valuation calculations. The key inputs used in the January 31, 2014 and July 31, 2013 fair value calculations were as follows:

 

   January 31, 2014   July 31, 2013 
Current exercise price  $0.03   $0.03 
Time to expiration   3.2 years    3.5 years 
Risk-free interest rate   0.69%   0.49%
Estimated volatility   86%   85%
Dividend   -0-    -0- 
Stock price at period end date  $0.03   $0.035 

 

Fair Value Assumptions Used in Accounting for Derivative Additional Investment Rights Liability

The Company has determined the derivative additional investment rights liability to be a Level 2 fair value measurement and has used the binominal lattice pricing model to measure the fair value. The fair value of the derivative liability associated with the additional investment rights was determined to be $126,195 and $1,256,160 at January 31, 2014 and July 31, 2013, respectively.

 

 

The key inputs used in the fair value calculation at January 31, 2014 and July 31, 2013 were as follows:

 

   January 31, 2014   July 31, 2013 
Underlying number of units of convertible preferred stock   425    1,225 
Underlying number of units of warrants   14,166,667    40,833,335 
Current exercise price of warrants  $0.03   $0.03 
Current conversion price of preferred stock  $0.03   $0.03 
Time to expiration   0.38 years    0.88 years 
Risk-free interest rate   0.06%   0.11%
Estimated volatility   67%   114%
Dividend   -0-    -0- 
Stock price at period end date  $0.042   $0.035 

 

The partial exercise of the additional investment rights in the quarter ended January 31, 2014, resulted in a transfer from the derivative liability to additional paid in capital of $237,566, which was the estimated fair value of the additional investment rights exercised as of the date of exercise on January 15, 2014. The revaluation of the additional investment rights in the six-month period ended January 31, 2014, resulted in the recognition of a gain of $892,399 within the Company’s consolidated statements of operations, which is included in the total under the caption “Change in fair value of derivative liabilities”.

 

15
 

 

Note 11 – Income from Assets Held for Investment, net:

 

In August 2013, the Company sold a property which was held for investment for gross proceeds after real estate commissions of $883,780. This property had a net book value of $694,911, resulting in an accounting gain of $188,869 which is included in income from assets held for investment, net on the interim consolidated statement of operations. The property was secured by a mortgage which was discharged upon the sale, as described in the last paragraph of this note below. After the discharge of the mortgage ($606,806), as well as legal fees, interest, penalties and other costs ($73,628 in aggregate) the sale resulted in net cash proceeds to the Company of $203,346.

 

In September 2012, the Company sold its head office real estate in Toronto for gross proceeds after real estate commissions of $1,579,189. This property had a net book value of $585,064, resulting in an accounting gain of $994,125 which is included in income from assets held for investment, net on the interim consolidated statement of operations. The net proceeds after commissions and other expenses were used to discharge or partially discharge the first and second mortgages on the property. The first mortgage on the property, with remaining principal of $480,951, was discharged completely upon sale. The remaining net proceeds of $1,028,780 after expenses and the discharge of the first mortgages was used to partially discharge the second mortgage and the Company did not receive any of the net proceeds from this property sale.

 

The remaining income of $4,738 in this category in the six months ended January 31, 2014, pertains to rental income from properties held for investment, net of carrying and operating expenses, compared to $89,741 in the prior year period.

 

Prior to the August 2013 property sale, the properties held for investment had an interest only first mortgage which closed on November 30, 2012 with a principal amount $606,806, an interest rate of 9.75% compounded semi-annually and a maturity date of November 30, 2013. Upon the sale of the property, the mortgage was discharged.

 

 

Note 12 – Subsequent Events:

 

The Company has evaluated subsequent events occurring after the balance sheet date through the date the interim consolidated financial statements were issued and determined that there are no events requiring financial statement disclosure.

16
 

 

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

 

As used herein, the terms the “Company,” “Generex,” “we,” “us,” or “our” refer to Generex Biotechnology Corporation, a Delaware corporation. The following discussion and analysis by management provides information with respect to our financial condition and results of operations for the three and six-month periods ended January 31, 2014 and 2013. This discussion should be read in conjunction with the information contained in Part I, Item 1A - Risk Factors and Part II, Item 8 - Financial Statements and Supplementary Data in our Annual Report on Form 10-K for the year ended July 31, 2013, as amended, and the information contained in Part I, Item 1 - Financial Statements and Part II, Item 1A- Risk Factors in this Quarterly Report on Form 10-Q for the fiscal quarter ended January 31, 2014.

 

Forward-Looking Statements

 

We have made statements in this Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations and elsewhere in this Quarterly Report on Form 10-Q of Generex Biotechnology Corporation for the fiscal quarter ended January 31, 2014 that may constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (the "Act"). The Act limits our liability in any lawsuit based on forward-looking statements that we have made. All statements, other than statements of historical facts, included in this Quarterly Report that address activities, events or developments that we expect or anticipate will or may occur in the future, including such matters as our projections, future capital expenditures, business strategy, competitive strengths, goals, expansion, market and industry developments and the growth of our businesses and operations, are forward-looking statements. These statements can be identified by introductory words such as “may,” "expects," “anticipates,” "plans," "intends," "believes," "will," "estimates" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Our forward-looking statements address, among other things:

 

  · our expectations concerning product candidates for our technologies;
     

  · our expectations concerning existing or potential development and license agreements for third-party collaborations, acquisitions and joint ventures;
     

  · our expectations of when different phases of clinical activity may commence and conclude;
     

  · our expectations of when regulatory submissions may be filed or when regulatory approvals may be received; and
     

  · our expectations of when commercial sales of our products may commence and when actual revenue from the product sales may be received.

 

Any or all of our forward-looking statements may turn out to be wrong. They may be affected by inaccurate assumptions that we might make or by known or unknown risks and uncertainties. Actual outcomes and results may differ materially from what is expressed or implied in our forward-looking statements. Among the factors that could affect future results are:

 

  · the inherent uncertainties of product development based on our new and as yet not fully proven technologies;
     

  · the risks and uncertainties regarding the actual effect on humans of seemingly safe and efficacious formulations and treatments when tested clinically;
     

  · the inherent uncertainties associated with clinical trials of product candidates;
     

  · the inherent uncertainties associated with the process of obtaining regulatory approval to market product candidates;
     

  · the inherent uncertainties associated with commercialization of products that have received regulatory approval;
     

 

·

the further decline in our stock price;

     
 

·

our ability to pay dividends on our recently issued preferred stock; and
     

  · our ability to obtain the necessary financing to fund our operations and effect our strategic development plan.

 

Additional factors that could affect future results are set forth in Part I, Item 1A Risk Factors of our Annual Report on Form 10-K for the year ended July 31, 2013, as amended, and in Part II, Item 1A. Risk Factors of this Quarterly Report on Form 10-Q. We caution investors that the forward-looking statements contained in this Quarterly Report must be interpreted and understood in light of conditions and circumstances that exist as of the date of this Quarterly Report. We expressly disclaim any obligation or undertaking to update or revise forward-looking statements to reflect any changes in management's expectations resulting from future events or changes in the conditions or circumstances upon which such expectations are based.

17
 

Executive Summary

 

Overview of Business

 

We are engaged primarily in the research and development of drug delivery systems and technologies. Our primary focus at the present time is our proprietary technology for the administration of formulations of large molecule drugs to the oral (buccal) cavity using a hand-held aerosol applicator. Through our wholly-owned subsidiary, Antigen Express, Inc. (“Antigen”), we have expanded our focus to include immunomedicines incorporating proprietary vaccine formulations.

 

We believe that our buccal delivery technology is a platform technology that has application to many large molecule drugs and provides a convenient, non-invasive, accurate and cost-effective way to administer such drugs. We have identified several large molecule drugs as possible candidates for development, including estrogen, heparin, monoclonal antibodies, human growth hormone and fertility hormones, but to date have focused our development efforts primarily on one pharmaceutical product, Generex Oral-lyn™, an insulin formulation administered as a fine spray into the oral cavity using our proprietary hand-held aerosol spray applicator known as RapidMist™.

 

Our wholly-owned subsidiary, Antigen, concentrates on developing proprietary vaccine formulations that work by stimulating the immune system to either attack offending agents (i.e., cancer cells, bacteria, and viruses) or to stop attacking benign elements (i.e., self proteins and allergens). Our immunomedicine products are based on two platform technologies and are in the early stages of development. We continue clinical development of Antigen’s synthetic peptide vaccines designed to stimulate a potent and specific immune response against tumors expressing the HER-2/neu oncogene for patients with HER-2/neu positive breast cancer in a Phase II clinical trial and patients with prostate cancer and against avian influenza in two Phase I clinical trials. We recently initiated an additional Phase I clinical trial in patients with either breast or ovarian cancer. The synthetic vaccine technology has certain advantages for pandemic or potentially pandemic viruses, such as the H5N1 avian and H1N1 swine flu. In addition to developing vaccines for pandemic influenza viruses, we have vaccine development efforts underway for seasonal influenza virus, HIV, HPV, melanoma, ovarian cancer, allergy and Type I diabetes mellitus. We have established collaborations with clinical investigators at academic centers to advance these technologies.

 

Financial Condition

 

We are a development stage company with a limited history of operations, and do not expect sufficient revenues to support our operation in the immediately foreseeable future. To date, we have not been profitable and our accumulated net loss available to shareholders was $370,953,051 at January 31, 2014. As of January 31, 2014, our current cash position is not sufficient to meet our working capital needs for the next twelve months. To continue operations, we will require additional funds to support our working capital requirements and any development activities, or will need to suspend operations. Management is seeking various alternatives to ensure that we can meet some of our operating cash flow requirements through financing activities, such as private placement of our common stock, preferred stock offerings and offerings of debt and convertible debt instruments as well as through merger or acquisition opportunities. In addition, management is actively seeking strategic alternatives, including strategic investments and divestitures. Management has sold non-essential real estate assets which were classified as Assets Held for Investment to augment its cash position. We cannot provide any assurance that we will obtain the required funding. Our inability to obtain required funding in the near future or our inability to obtain funding on favorable terms will have a material adverse effect on our operations and our strategic development plan for future growth. If we cannot successfully raise additional capital and implement our strategic development plan, our liquidity, financial condition and business prospects will be materially and adversely affected and we may have to cease operations.

 

Generex Oral-lyn™

 

Regulatory Approvals and Clinical Trials

 

To date, we have received regulatory approval in Ecuador, India (subject to marketing approval of in-country clinical study), Lebanon and Algeria for the commercial marketing and sale of Generex Oral-lyn™. No dossier related activities took place in any other countries during fiscal 2013 or the first half of fiscal 2014, nor are any expected during the remainder of fiscal 2014.

 

In March 2008, we initiated Phase III clinical trials for this product in the U.S. with the first patient screening for such trials at a clinical study site in Texas in April 2008. Approximately 450 patients have been enrolled to date at approximately 70 clinical sites around the world, including sites in the United States, Canada, Bulgaria, Poland, Romania, Russia, Ukraine and Ecuador. The first Oral-lyn™ global Phase III trial initiated in April 2008 had a final patient visit date in August 2011. After appropriate validation, the data from approximately 450 patients was tabulated, reviewed and analyzed. Those results from the Phase III trial along with a comprehensive review and supplemental analyses of approximately 40 prior Oral-lyn™ clinical studies were compiled and submitted to the FDA in late December 2011 in a comprehensive package including a composite meta-analysis of all safety data. We are currently in ongoing discussions with the FDA with respect to the pathway for regulatory approval, including any additional clinical or pharmacological studies that might be required to support regulatory approval or enhance marketing success. We do not currently plan to expend significant resources on additional clinical trials of Oral-lyn™ until after such time that we secure additional financing.

 

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Marketing

 

We have entered into licensing and distribution agreements with a number of multinational distributors to assist us with the process of gaining regulatory approval for the registration, marketing, distribution, and sale of Generex Oral-lyn™ in countries throughout the world. Under these licensing and distribution agreements, excluding one with Dong Sung Pharm Co. in South Korea, we will not receive an upfront license fee, but the distributor will bear any and all costs associated with the procurement of governmental approvals for the sale of Generex Oral-Lyn™, including any clinical and regulatory costs. We possess the worldwide marketing rights to our oral insulin product.

 

In India, a marketing plan has been submitted by Shreya Life Sciences Pvt. Ltd., to Generex on the marketing strategy for the distribution of Oral Recosulin™, the trademark under which Shreya will market Generex Oral-lyn™ within India. The marketing plan also includes post-approval marketing studies. Per the requirements of the regulatory approval in India, an in-country clinical study must be completed in India with Oral Recosulin™ before commercial sales can commence. The field portion of the study was completed in the third calendar quarter of 2012.  The marketing acceptance dossier has been submitted to the Indian regulatory authority. Generex has provided additional, detailed scientific data to support the Shreya submission. We have not recognized any revenues from the sale of Generex Oral-lyn™ in India through the end of the 2013 fiscal year or in the first half of the 2014 fiscal year.

 

We do not currently plan to expend significant resources on additional clinical trials or to further the commercialization of Generex Oral-lyn™ until after such time that we secure additional financing.

 

Cancer and Immunotherapeutic Vaccine Platforms

 

Our wholly-owned subsidiary Antigen Express is developing proprietary vaccine formulations based upon two platform technologies that were discovered by its founder, the Ii-Key hybrid peptides and Ii-Suppression. These technologies are applicable for either antigen-specific immune stimulation or suppression, depending upon the dosing and formulation of its products. Using active stimulation, we are focusing on major diseases such as breast, prostate and ovarian cancer, melanoma, influenza (including H5N1 avian and H1N1 swine flu) and HIV. Autoimmune diseases such as diabetes and multiple sclerosis are the focus of our antigen-specific immune suppression work.

 

Antigen’s immunotherapeutic vaccine AE37 is currently in Phase II clinical trials for patients with HER-2/neu positive breast cancer. The trial is being conducted with the United States Military Cancer Institute's (USMCI) Clinical Trials Group and will examine the rate of relapse in patients with node-positive or high-risk node-negative breast cancer after two years. The study is randomized and will compare patients treated with AE37 plus the adjuvant GM-CSF versus GM-CSF alone. The Phase II trial follows a Phase I trial that demonstrated safety, tolerability, and immune stimulation of the AE37 vaccine in breast cancer patients.

 

Based on positive results in trials of the AE37 vaccine in breast cancer patients, we entered into an agreement in August 2006 with the Euroclinic, a private center in Athens, Greece, to commence clinical trials with the same compound as an immunotherapeutic vaccine for prostate cancer. A Phase I trial involving 29 patients was completed in August 2009, which similarly showed safety, tolerability and induction of a specific immune response. Agreements, as well as a protocol, are in place for initiation of a Phase II clinical trial once additional funding is available.

 

The same technology used to enhance immunogenicity is being applied in the development of a synthetic peptide vaccine for H5N1 avian influenza and the 2009 H1N1 swine flu. In April 2007, a Phase I clinical trial of Antigen’s proprietary peptides derived from the hemagglutinin protein of the H5N1 avian influenza virus was initiated in healthy volunteers in the Lebanese-Canadian Hospital in Beirut, Lebanon. We have completed the first portion of the Phase I trial. Modified peptide vaccines for avian influenza offer several advantages over traditional egg-based or cell-culture based vaccines. Modified peptide vaccines can be manufactured by an entirely synthetic process which reduces cost and increases both the speed and quantity of vaccine relative to egg- or cell-culture based vaccines. Another advantage is that the peptides are derived from regions of the virus that are similar enough in all H5N1 and H1N1 virus strains such that they would not have to be newly designed for the specific strain to emerge in a pandemic.

 

A Physician’s Investigational New Drug (“IND”) application for the Phase I and Phase II trials in patients with stage II HER-2/neu positive breast cancer has been filed with the FDA. The Phase I trial was completed at the Walter Reed Army Medical Center in Washington, D.C., and the Phase II trial is taking place at 13 sites, including 11 in the U.S., one in Germany and one in Greece. A Physician’s Investigational New Drug application for a Phase I trial in patients with breast or ovarian cancer also has been filed with the FDA and this Phase I trial is being conducted in Dallas, Texas at the Mary Crowley Cancer Center. Applications were filed and approvals obtained for a Phase I prostate cancer trial using AE37 in Athens, Greece from the Hellenic Organization of Drugs, and this Phase I trial was completed in August 2009. The Ministry of Health in Lebanon gave approval for Phase I trial of our experimental H5N1 prophylactic vaccine in Beirut, Lebanon following submission of an application. All other immunomedicine products are in the pre-clinical stage of development.

 

Other Potential Buccal Products

 

We have had past discussions regarding possible research collaborations with various pharmaceutical companies concerning use of our large molecule drug delivery technology with other compounds, including monoclonal antibodies, human growth hormone, fertility hormone, estrogen and heparin, and a number of vaccines. We have not expended resources to further develop any of these products during the fiscal year ended July 31, 2013 or in the first half of fiscal 2014 and do not currently have any plans to expend further resources on these products.

 

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Competition

 

We face competition from other providers of alternate forms of insulin. Some of our most significant competitors, Pfizer, Eli Lilly, and Novo Nordisk, have announced that they will discontinue development and/or sale of their inhalable forms of insulin. Generex Oral-lyn™ is not an inhaled insulin; rather, it is a buccally absorbed formulation with no residual pulmonary deposition. We believe that our buccal delivery technology offers several advantages, including the ease of use, portability, avoidance of pulmonary inhalation and safety profile. Furthermore, insulin administered through the Generex Oral-lyn™ RapidMist™ technology is absorbed directly into the blood stream and not only acts rapidly, but returns to baseline quickly, thereby minimizing the chance of developing hypoglycemia.

 

In May 2009, Mannkind Corporation submitted an NDA to the FDA requesting approval to market AFREZZA® (insulin human [rDNA origin]) Inhalation Powder, for the treatment of adult patients with Type 1 and Type 2 diabetes for the control of hyperglycemia. In January 2011, MannKind announced that it had received a complete response letter from the FDA for AFREZZA®. In August 2011, MannKind announced that it has confirmed with the FDA the design of the two additional clinical studies which are required for AFREZZA®. In August 2013, MannKind announced positive late-stage data on its inhaled insulin AFREZZA® from the two additional Phase III studies on Type 1 and Type 2diabetes and has resubmitted a new drug application to the FDA in October 2013 seeking approval for the marketing of AFREZZA®. In addition to other delivery systems for insulin, there are numerous products, such as sulfonylureas (Amaryl®and Glynase®), biguanides (branded and generic metformin products), thiazolidinediones (Avandia®and Actos®), glucagon-like peptide 1 (Byetta®and Victoza®), and dipeptidyl peptidase IV inhibitors (Januvia® and Onglyza™), which have been approved for use in the treatment of Type 2 diabetics in substitution of, or in addition to, insulin therapy. These products may also be considered competitive with insulin products.

 

Large pharmaceutical companies, such as Merck & Co., Inc., GlaxoSmithKline PLC, Novartis, Inc., MedImmune Inc. (a subsidiary of Astra-Zeneca, Inc.) and others, also compete against us in the oncology, immunomedicine and vaccine markets. These companies have competing experience and expertise in securing government contracts and grants to support research and development efforts, conducting testing and clinical trials, obtaining regulatory approvals to market products, as well as manufacturing and marketing approved products. As such, they are also considered significant competitors in these fields of pharmaceutical products and therapies. There are also many smaller companies which are pursuing similar technologies in these fields who are considered to be competitors of Generex.

 

Brief Company Background

 

We are a development stage company. From inception through the end of the quarter ended January 31, 2014, we have received only limited revenues from operations. We did not have any revenue for the six months ended January 31, 2014 or in the fiscal year ended July 31, 2013

 

We operate in only one segment: the research and development of drug delivery systems and technologies for metabolic and immunological diseases.

 

We were incorporated in the State of Delaware in 1997. Our principal executive offices are located at 555 Richmond Street West, Suite 604, Toronto, Canada, and our telephone number at that address is (416) 364-2551. We maintain an Internet website at www.generex.com.  We make available free of charge on or through our website our filings with the SEC.

 

Accounting for Research and Development Projects

 

Our major research and development projects are the refinement of our platform buccal delivery technology, our buccal insulin project (Generex Oral-lyn™) and Antigen’s peptide immunotherapeutic vaccines.

 

During the first six months of the current fiscal year and during the last fiscal year, we expended resources on the clinical testing and results analysis of our buccal insulin product, Generex Oral-lyn™. In July 2007, we received no objection from the FDA to proceed with our long-term multi-center Phase III study protocol for Generex Oral-lyn™. The first Oral-lyn global Phase III trial initiated in April 2008 had a final patient visit date in August 2011. After appropriate validation, the data from approximately 450 patients was tabulated, reviewed and analyzed. Those results from the Phase III trial along with a comprehensive review and supplemental analyses of approximately 40 prior Oral-lyn clinical studies were compiled and submitted to the FDA in late December 2011 in a comprehensive package including a composite meta-analysis of all safety data. We are currently in ongoing discussions with the FDA with respect to the pathway for regulatory approval, including any additional clinical or pharmacological studies that might be required to support regulatory approval or enhance marketing success. Late-stage trials involve testing our product with a large number of patients over a significant period of time. The completion of late-stage trials in Canada and the United States will require significantly greater funds than we currently have on hand. We do not currently plan to expend significant resources on additional clinical trials of Oral-lyn™ until after such time that we secure additional financing.

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During the first six months of the current fiscal year and during the last fiscal year, we expended resources on research and development relating to Antigen’s peptide immunotherapeutic vaccines and related technologies. Antigen has one vaccine currently in Phase II clinical trials in the United States involving patients with HER-2/neu positive breast cancer and has completed a Phase I clinical trial for a vaccine for H5N1 avian influenza at the Lebanese-Canadian Hospital in Beirut. Antigen’s prostate cancer vaccine based on AE37 has been tested in a completed (August 2009) Phase I clinical trial in Greece.

 

Because of various uncertainties, we cannot predict the timing of completion and commercialization of our buccal insulin in all jurisdictions or Antigen’s peptide immunotherapeutic vaccines or related technologies. These uncertainties include the success of current studies, our ability to obtain the required financing and the time required to obtain regulatory approval even if our research and development efforts are completed and successful, our ability to enter into collaborative marketing and distribution agreements with third-parties, and the success of such marketing and distribution arrangements. For the same reasons, we cannot predict when any products may begin to produce net cash inflows.

 

Most of our buccal delivery research and development activities to date have involved developing our platform technology for use with insulin. Insubstantial amounts have been expended on projects with other drugs, including morphine and fentanyl, and those projects involved a substantial amount of platform technology development. As a result, we have not made significant distinctions in the accounting for research and development expenses among products, as a significant portion of all research has involved improvements to the platform technology in connection with insulin, which may benefit all of our potential buccal products. During the six months ended January 31, 2014, approximately 25% of our $749,773 in research and development expenses was attributable to insulin and platform technology development.  During the six months ended January 31, 2013, approximately 20% of our $1,153,877 in research and development expenses was attributable to insulin and platform technology development.

 

During the six months ended January 31, 2014, approximately 75% of our $749,773 in research and development expenses was attributable to Antigen's immunomedicine products compared to approximately 80%, or $926,090 for the six months ended January 31, 2013.  Because these products are in initial phases of clinical trials or early, pre-clinical stage of development (with the exception of the Phase II clinical trials of Antigen HER-2/neu positive breast cancer vaccine that are underway), all of the expenses were accounted for as basic research and no distinctions were made as to particular products. Due to the early stage of development, we cannot predict the timing of completion of any products arising from this technology, or when products from this technology might begin producing revenues.

 

Critical Accounting Policies

 

Our discussion and analysis of our financial condition and results of operations is based on our interim consolidated financial statements which have been prepared in conformity with accounting principles generally accepted in the United States of America for interim financial statements. These principles require management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

 

We consider certain accounting policies related to impairment of long-lived assets, intangible assets and accrued liabilities to be critical to our business operations and the understanding of our results of operations:

 

Going Concern.  As shown in the consolidated interim financial statements, we have not been profitable and have reported recurring losses from operations.  These factors raise substantial doubt about our ability to continue to operate in the normal course of business.  The consolidated interim financial statements do not include any adjustments that might be necessary should we be unable to continue as a going concern.

 

Revenue Recognition. Net sales of our over-the-counter confectionary products are generally recognized in the period in which the products are delivered. Delivery of the products generally completes the criteria for revenue recognition for us. In the event where the customers have the right of return, sales are deferred until the right of return lapses, the product is sold to a third party or a provision for returns can be reasonably estimated based on historical experience.

 

Impairment of Long-Lived Assets. Management reviews for impairment whenever events or changes in circumstances indicate that the carrying amount of property and equipment may not be recoverable under the provisions of accounting for the impairment of long-lived assets. If it is determined that an impairment loss has occurred based upon expected future cash flows, the loss is recognized in the Statement of Operations. As of January 31, 2014, there were no indications of any impairments of our long-lived assets.

 

Intangible Assets. We have intangible assets related to patents. The determination of the related estimated useful lives and whether or not these assets are impaired involves significant judgments. In assessing the recoverability of these intangible assets, we use an estimate of undiscounted operating income and related cash flows over the remaining useful life, market conditions and other factors to determine the recoverability of the asset. If these estimates or their related assumptions change in the future, we may be required to record impairment charges against these assets. There have been no patent write downs or disposals in fiscal 2013 or in the 2014 fiscal year to date.

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Estimating accrued liabilities, specifically litigation accruals. Management's current estimated range of liabilities related to pending litigation is based on management's best estimate of future costs. While the final resolution of the litigation could result in amounts different than current accruals, and therefore have an impact on our consolidated financial results in a future reporting period, management believes the ultimate outcome will not have a significant effect on our consolidated results of operations, financial position or cash flows.

 

Share-based compensation. Management determines value of stock-based compensation to employees in accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 718, Compensation – Stock Compensation. Management determines value of stock-based compensation to non-employees and consultants in accordance with and ASC 505, Equity-Based Payments to Non-Employees.

 

Derivative warrant liability.  FASB ASC 815, Derivatives and Hedging, requires all derivatives to be recorded on the balance sheet at fair value for fiscal years beginning after December 15, 2008.  As a result, certain derivative warrant liabilities (namely those with a price protection feature) are now separately valued as of August 1, 2009 and accounted for on our balance sheet, with any changes in fair value recorded in earnings.  For our balance sheets as of January 31, 2014 and July 31, 2013, we used the binomial lattice model to estimate the fair value of these warrants. Key assumptions of the binomial lattice option-pricing model include the market price of our stock, the exercise price of the warrants, applicable volatility rates, risk-free interest rates, expected dividends and the instrument’s remaining term.  These assumptions require significant management judgment.  In addition, changes in any of these variables during a period can result in material changes in the fair value (and resultant gains or losses) of this derivative instrument.

 

Results of Operations

 

Three months ended January 31, 2014 compared to three months ended January 31, 2013

 

We had a net loss for the quarter ended January 31, 2014 of $3,186,290 versus a net loss of $5,640,985 in the corresponding quarter of the prior fiscal year. The loss in this year’s fiscal quarter was caused primarily by a loss due to the change in fair value of the derivative liabilities of $2,107,844 and operating expenses of $1,010,861, while in the prior year the loss due to the change in fair value of the derivative liabilities was $4,142,004 and operating expenses were $1,290,780. Our operating loss for the quarter ended January 31, 2014 decreased to $1,010,861 compared to $1,290,780 in the same fiscal quarter of 2013.  The decrease in operating loss resulted from a decrease in research and development expenses (to $213,599 from $500,482) offset by a slight increase in general and administrative expenses (to $797,262 from $790,298). We did not have any revenues in either of the quarters ended January 31, 2014 or 2013.

 

The decrease in research and development expenses in the current fiscal quarter versus the comparative quarter in the previous fiscal year is primarily due to there being no installments to the contract research organization for the Antigen Phase II clinical trial. Our efforts to significantly reduce expenses in all categories also contributed to the decrease in this category. In the general and administrative expense category, most categories of expenses were similar in amount as compared to the previous year quarter ended January 31, 2013, as we continued our efforts to conserve cash until we complete the strategic development plan announced by management on March 30, 2011.

 

Our interest expense in the second quarter of fiscal 2013 was $67,608 compared to the previous year’s fiscal quarter at $249,821 due to the lower fees and costs associated with the November 2012 property refinancing, as well as lower penalties incurred upon the early discharge of the mortgages on the sale of our properties held for investment and office property.   We did not have any income from assets held for investment (net of expense) in the second quarter of fiscal 2014 compared to $40,998 in the same quarter of the previous fiscal year, as we have sold all these properties prior to this fiscal quarter. Change in fair value of derivative liabilities contributed a loss of $2,107,844 in the second quarter of fiscal 2014compared to a loss of $4,142,004 in the second quarter of fiscal 2013.

 

Our net income available to shareholders was decreased by $408,279 in the second quarter of fiscal 2014 relating to a preferred stock dividend as a result of the accounting treatment of our convertible preferred stock financing in January 2014. This amount represents a deemed dividend to the investors as a result of this financing, as further described in Note 9 to the Notes to Consolidated Financial Statements included elsewhere in this Quarterly Report.  There was no preferred stock dividend in the comparable period of fiscal 2013.

 

Six months ended January 31, 2014 compared to six months ended January 31, 2013

 

We had a net loss for the six months ended January 31, 2014 of $2,656,196 versus a net loss of $6,297,184 in the corresponding six months of the prior fiscal year. The loss in this year’s fiscal period was caused primarily operating expenses of $2,453,912 and a loss due to the change in fair value of the derivative liabilities of $230,557, while in the prior year operating expenses were $3,230,811 and the loss due to the change in fair value of the derivative liabilities was $3,783,290. Our operating loss for the six months ended January 31, 2014 decreased to $2,453,912 compared to $3,230,811 in the same fiscal six months of 2013.  The decrease in operating loss resulted from a decrease in research and development expenses (to $749,773 from $1,153,877) and a decrease in general and administrative expenses (to $1,704,139 from $2,076,934). We did not have any revenues in either of the six-month periods ended January 31, 2014 or 2013.

 

The decrease in research and development expenses in the current fiscal year versus the comparative period in the previous fiscal year is primarily due to there being no significant expenditures in this fiscal year related to the field portion of the global Phase III clinical trials of our oral insulin product and platform technology which was completed in in the first quarter of the prior fiscal year and there were no installments due to the contract research organization for the Antigen Phase II clinical trial in the most recent fiscal quarter. Our efforts to significantly reduce expenses in all categories also contributed to the decrease in this category. The decrease in general and administrative expenses is related to a decrease in professional services expenses, including legal and consulting services of approximately $240,000, in addition to a decrease in payroll related expenses of approximately $36,000 and a decrease in office related expenses of approximately $51,000 in the six months ended January 31, 2014, as compared to the previous year six months ended January 31, 2013. We also incurred reductions of expenses in most other categories due to our efforts to conserve cash until we complete the strategic development plan announced by management on March 30, 2011.

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Our interest expense in the first six months of fiscal 2013 was $165,380 compared to the previous year’s fiscal period at $367,256 due to the lower fees and costs associated with the November 2012 property refinancing, as well as lower penalties incurred upon the early discharge of the mortgages on the sale of our properties held for investment and office property.   We recognized lower income from assets held for investment (net of expense) of $193,607 in the first half of fiscal 2014 compared to $1,083,866 in the same period of the previous fiscal year due to the almost $1.0 million accounting gain on the aforementioned property sale in the fiscal 2013 period. Change in fair value of derivative liabilities contributed a loss of $230,557 in the first six months of fiscal 2014compared to a loss of $3,783,290 in the first six months of fiscal 2013.

 

Our net income available to shareholders was decreased by $408,279 in the first six months of fiscal 2014 relating to a preferred stock dividend as a result of the accounting treatment of our convertible preferred stock financing in January 2014 versus a preferred stock dividend of $102,297 in the comparable fiscal 2013 period. These amounts represent deemed dividends to the investors as a result of financings in January 2014 and August 2012, respectively, as further described in Note 9 to the Notes to Consolidated Financial Statements included elsewhere in this Quarterly Report. 

 

 

Financial Condition, Liquidity and Resources

 

Sources of Liquidity

 

To date we have financed our development stage activities primarily through private placements of our common stock and securities convertible into our common stock.

 

As of January 31, 2014, our current cash position is not sufficient to meet our working capital needs for the next twelve months. Therefore, we will require additional funds to support our working capital requirements and any development or other activities, or will need to curtail our clinical trials and other planned activities or suspend operations.

 

While we have financed our development stage activities to date primarily through private placements of our common stock and securities convertible into our common stock and raised approximately $5.3 million during fiscal 2013 (including the proceeds from our mortgage financing in November 2012 and proceeds from warrant exercises) and approximately $3.1 million during fiscal 2014 to date (including proceeds from warrant exercises and the net proceeds from the sale of our properties held for investment), our cash balances have been low thus far in fiscal 2014.

 

On March 30, 2011, our realigned management team announced its strategic development plan for Generex’s future growth. The plan included the spin-out of Antigen Express, a reverse stock split for Generex and a rights offering to Generex stockholders. As proposed, we would spin out Antigen Express as a separate DTC-eligible company, register its shares with the Securities and Exchange Commission (the “SEC”), and seek to list its shares on a national securities exchange. Management believes that the spin-out would increase value for stockholders and provide Antigen Express with ready access to capital markets to finance its on-going clinical and regulatory initiatives. Management further believes that the spin-out would benefit Generex, by allowing Generex to hold a controlling interest in a publicly-traded company while continuing to focus on maximizing opportunities for its buccal drug delivery platform. The spin-out would be accomplished by the issuance of one or more dividends of Antigen Express stock to Generex stockholders. No determination has been made as to the timing of the proposed spin-out. This Quarterly Report on Form 10-Q does not constitute an offer of any securities for sale or a solicitation of an offer to buy any securities.

 

Although stockholders approved a reverse split proposal at our annual general meeting held on March 28, 2013, which approval allows the Board to implement a reverse split in its discretion and is not contingent upon listing our common stock on a national stock exchange, the terms of the securities purchase agreements that we entered into on June 17, 2013 and January 2014 prohibit us from undertaking a reverse or forward stock split or reclassification of our common stock except for a reverse stock split made in conjunction with a listing of the common stock on a national securities exchange.

 

Management may seek to meet all or some of our operating cash flow requirements through financing activities, such as private placement of our common stock, preferred stock offerings and offerings of debt and convertible debt instruments as well as through merger or acquisition opportunities.  The securities purchase agreements that we entered into on June 17, 2013and January 14, 2014 with certain investors prohibits us from (i) issuing additional equity securities until 60 days after the effective date of a registration statement covering the resale of the common stock issuable upon exercise of the warrants and conversion of the preferred stock sold in that transaction and (ii) issuing additional debt or equity securities with a variable conversion or exercise price until June 17, 2014 and January 14, 2015, respectively.

 

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Upon the filing of our Annual Report on Form 10-K on October 14, 2011, we were no longer eligible to use Form S-3 to register shares sold to investors, as the aggregate market value of our outstanding voting and non-voting common equity held by non-affiliates was less than $75 million. As we are required under the registration rights agreements that we entered into on January 31, 2012, August 8, 2012, December 10, 2012, June 17, 2013 and January 14, 2014 with certain investors to register shares of our common stock issuable upon conversion or exercise of the securities purchased by the investors, we filed the respective registration statements on Form S-1. We incurred additional legal and accounting fees in connection with the preparation of these Form S-1 registration statements.

 

In addition, management is actively pursuing financial and strategic alternatives, including strategic investments and divestitures, industry collaboration activities, and potential strategic partners. Management has sold, and is also seeking further sales of, non-essential real estate assets which are classified as Assets Held for Investment to augment its cash position and reduce its long-term debt.

 

We believe that the successful commercial launch of Oral-lyn™ in countries where we have approval would enhance our ability to access additional sources of funding.  We will continue to require substantial funds to continue research and development, including preclinical studies and clinical trials of our product candidates, further clinical trials for Oral-lyn™ and to commence sales and marketing efforts if the FDA or other regulatory approvals are obtained.  

 

Unforeseen problems with the conduct or results of Phase III clinical trials for Oral-lyn™ or further negative developments in general economic conditions could interfere with our ability to raise additional capital as needed, or materially adversely affect the terms upon which such capital is available.   We cannot provide any assurance that we will obtain the required funding. Our inability to obtain required funding in the near future or our inability to obtain funding on favorable terms will have a material adverse effect on our operations and our strategic development plan for future growth. If we cannot successfully raise additional capital and implement our strategic development plan, our liquidity, financial condition and business prospects will be materially and adversely affected and we may have to cease operations.

 

Proceeds from Recent Financings

 

Series E 9% Convertible Preferred Stock and Warrants”Greenshoe”

 

On June 17, 2013, we entered into a securities purchase agreement with certain investors, pursuant to which we agreed to sell an aggregate of 1,225 shares of our newly designated non-voting Series E 9% Convertible Preferred Stock and warrants to purchase up to an aggregate of 100% of the shares of our common stock issuable upon conversion of the convertible preferred stock. Under the June 17, 2013 securities purchase agreement, for a period of up to one year, each investor may, in its sole determination, elect to purchase, in one or more purchases, additional units consisting of convertible preferred stock and warrants at a purchase price in the amount originally purchased by such investor (the “Greenshoe”). The units purchased in the Greenshoe will be identical to the units of convertible preferred stock and warrants originally issued pursuant to the Stock Purchase Agreement.

 

On January 14, 2014, in connection with the exercise of the Greenshoe by certain investors, we entered into a securities purchase agreement, pursuant to which we agreed to sell an aggregate of 800 shares of our Series E 9% Convertible Preferred Stock and warrants to purchase up to an aggregate of 100% of the shares of our common stock issuable upon conversion of the convertible preferred stock. The purchase closed on January 15, 2014. Each unit was sold at a negotiated price of $1,000, for an aggregate purchase price of $800,000. An aggregate of 53,333,336 shares of the Company’s common stock are initially issuable upon conversion of, or exercise of, the convertible preferred stock and warrants.

 

With very limited exceptions, the investors will have a pro rata right of first refusal in respect of participation in any private debt or equity financings undertaken by us during the 12 months following the closing of the transaction.

 

We offered these securities privately pursuant to Rule 506(b) of Regulation D under the Securities Act of 1933. This offering is subject to the registration rights agreement dated June 17, 2013 with the investors pursuant to which we agreed to file a registration statement with the SEC covering the public resale of the common stock issuable upon conversion of the preferred stock, issuable as dividends on the preferred stock, issuable upon exercise of the warrants and issued as a finders’ fee.

 

We agreed to file the registration statement within 25 days of the closing of the transaction and to use our best efforts to have the registration statement declared effective within 75 days after the filing date. If these deadlines are not met, we will be liable for liquidated damages up to 6% of the purchase price under the securities purchase agreement. The registration statement was declared effective by the SEC on February 7, 2014. 

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In addition, if, during the six-month period after the issuance of the warrants and continuing until such time that all of the securities may be sold without our meeting the current public information requirement under Securities Act rule 144(c)(1), we fail to meet such requirement, we will pay liquidated damages equal to 2.0% of the purchase price paid by each investor, payable in cash every 30 days until current public information for Generex is available or is no longer required for the investors to rely on Rule 144 to transfer the securities (including underlying securities) acquired under the securities purchase agreement.

 

Financing –June 2013

Series E 9% Convertible Preferred Stock and Warrants

 

On June 17, 2013, we entered into a securities purchase agreement with certain investors, pursuant to which we agreed to sell an aggregate of 1,225 shares of our newly designated non-voting Series E 9% Convertible Preferred Stock and warrants to purchase up to an aggregate of 100% of the shares of our common stock issuable upon conversion of the convertible preferred stock. The purchase closed on June 20, 2013. We sold the convertible preferred stock and warrants in units, with each unit consisting of one share of convertible preferred stock and a warrant to purchase 100% of the shares of the Company’s common stock issuable upon conversion of such share of convertible preferred stock. Each unit was sold at a negotiated price of $1,000, for an aggregate purchase price of $1,225,000. An aggregate of 81,666,670 shares of our common stock are issuable upon conversion of, or exercise of, the convertible preferred stock and warrants. We received net proceeds of approximately $1,165,000 from this transaction, which was reflected in the fourth quarter of the annual consolidated financial statements for the fiscal year ending July 31, 2013.

 

Subject to certain ownership limitations, the Series E convertible preferred stock will be convertible at the option of the holder at any time into shares of our common stock at an effective conversion price of $0.03 per share, and will accrue a 9% dividend until June 17, 2016 and, beginning on June 17, 2016 and on each one year anniversary thereafter, such dividend rate will increase by an additional 3%. The dividend will be payable quarterly on September 30, December 31, March 31 and June 30, beginning on the first such date after the original issue date and on each conversion date in cash, or at our option, in shares of common stock. In the event that the convertible preferred stock is converted prior to June 17, 2016, we will pay the holder of the converted preferred stock an amount equal to $270 per $1,000 of stated value of the convertible preferred stock, less the amount of all prior quarterly dividends paid on such converted preferred stock before the relevant conversion date. Such “make-whole payment” may be made in cash or, at our option, in shares of our common stock. In addition, beginning June 17, 2016, we will pay dividends on shares of preferred stock equal to (on an as-if-converted-to-common-stock basis) and in the same form as dividends (other than dividends in the form of common stock) actually paid on shares of the common stock when, as and if such dividends are paid. We will incur a late fee of 18% per annum on unpaid dividends.

 

The conversion price of the Series E convertible preferred stock will be subject to adjustment in the case of stock splits, stock dividends, combinations of shares, similar recapitalization transactions and certain pro-rata distributions to common stockholders. The conversion price will also be adjusted if we sell or grant any shares of common stock or securities convertible into, or rights to acquire, common stock at an effective price per share that is lower than the then conversion price, except in the event of certain exempt issuances. In addition, the holders of convertible preferred stock will be entitled to receive any securities or rights to acquire securities or property granted or issued by us pro rata to the holders of our common stock to the same extent as if such holders had converted all of their shares of convertible preferred stock. In the event of a fundamental transaction, such as a merger, consolidation, sale of substantially all assets and similar reorganizations or recapitalizations, the holders of convertible preferred stock will be entitled to receive, upon conversion of their shares, any securities or other consideration received by the holders of our common stock pursuant to the fundamental transaction.

 

We may become obligated to redeem the Series E convertible preferred stock in cash upon the occurrence of certain triggering events, including, material breach of certain contractual obligations to the holders of the convertible preferred stock, the occurrence of a change in control of Generex, the occurrence of certain insolvency events relating to Generex, or the failure of our common stock to continue to be listed or quoted for trading on one or more specified United States securities exchanges or regulated quotation service. Upon the occurrence of certain triggering events, each holder of convertible preferred stock will have the option to redeem such holder’s shares of convertible preferred stock for a redemption price payable in shares of common stock or receive an increased dividend rate of 18% on all of such holder’s outstanding convertible preferred stock. Late fees will apply on all redemption amounts not paid within five trading days of the payment date.

 

Subject to certain ownership limitations, the warrants will be exercisable at any time after their date of issuance and on or before the fifth-year anniversary thereafter at an exercise price of $0.03 per share of common stock. The exercise price of the warrants and, in some cases, the number of shares issuable upon exercise, are subject to adjustment in the case of stock splits, stock dividends, combinations of shares, similar recapitalization transactions and certain pro-rata distributions to common stockholders. The exercise price and number of shares of common stock issuable upon exercise will also be adjusted if we sell or grant any shares of common stock or securities convertible into, or rights to acquire, common stock at an effective price per share that is lower than the then exercise price, except in the event of certain exempt issuances. In addition, the warrant holders will be entitled to receive any securities or rights to acquire securities or property granted or issued by us pro rata to the holders of our common stock to the same extent as if such holders had exercised all of their warrants. In the event of a fundamental transaction, such as a merger, consolidation, sale of substantially all assets and similar reorganizations or recapitalizations, the warrant holders will be entitled to receive, upon exercise of their warrants, any securities or other consideration received by the holders of common stock pursuant to the fundamental transaction.

 

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The securities purchase agreement and the certificate of designation authorizing the Series E convertible preferred stock include certain agreements and covenants for the benefit of the holders of the convertible preferred stock, including restrictions on our ability to amend the certificate of incorporation and bylaws, pay cash dividends or distributions with respect to our common stock or other junior securities, repurchase more than a de minimis number of shares of our common stock or other junior securities.

 

With very limited exceptions, the investors will have a pro rata right of first refusal in respect of participation in any private debt or equity financings undertaken by us during the 12 months following the closing of the transaction.

 

We offered these securities privately pursuant to Rule 506 of Regulation D under the Securities Act of 1933. We entered into a registration rights agreement with the investors pursuant to which we agreed to file a registration statement with the SEC covering the public resale of the common stock issuable upon conversion of the preferred stock, issuable as dividends on the preferred stock, issuable upon exercise of the warrants and issued as a finders’ fee.

 

We agreed to file the registration statement within 25 days of the closing of the transaction and to use our best efforts to have the registration statement declared effective within 75 days after the filing date. If these deadlines are not met, we will be liable for liquidated damages up to 6% of the purchase price under the securities purchase agreement. The registration statement was declared effective by the SEC on July 24, 2013.

 

In addition, until the first anniversary date of the securities purchase agreement, each investor may, in its sole determination, elect to purchase, severally and not jointly with the other investors, in one or more purchases, in the ratio of such investor's original subscription amount to the original aggregate subscription amount of all investors, additional units consisting of convertible preferred stock and warrants at a purchase price of $1,000 per unit with an aggregate subscription amount thereof of up to $1,225,000, which units will be identical to the units of convertible preferred stock and warrants issued in connection with the June 2013 closing. On January 15, 2014, certain investors exercised 800 of the 1,225 shares of convertible preferred stock and related warrants available under this Greenshoe. Certain investors will continue to have rights to purchase up to 425 shares of convertible preferred stock and related warrants under the Greenshoe until June 17, 2014.

 

In addition, if, during the six-month period after the issuance of the warrants and continuing until such time that all of the securities may be sold without our meeting the current public information requirement under Securities Act rule 144(c)(1), we fail to meet such requirement, we will pay liquidate damages equal to 2.0% of the purchase price paid by each investor, payable in cash every 30 days until current public information for Generex is available or is no longer required for the investors to rely on Rule 144 to transfer the securities (including underlying securities) acquired under the securities purchase agreement.

 

Proceeds from Warrant Exercises

 

We may receive additional proceeds from the exercise of warrants issued in the registered direct offerings conducted in June, August and September 2009, the sales to Seaside 88, LP in April, May and June 2010 and the warrants issued in February 2012, August 2012, December 2012 and June 2013 in connection with the issuance of the Series B 9% Convertible Preferred Stock, Series C 9% Convertible Preferred Stock, Series D 9% Convertible Preferred Stock and Series E 9% Convertible Preferred Stock, although some of the warrants include a cashless exercise feature.  

 

·In the transaction that closed on June 15, 2009, we sold shares of common stock and warrants exercisable for up to 8,600,000 shares of our common stock to investors and issued Midtown Partners & Co., LLC, our exclusive placement agent for the transaction, a warrant to purchase up to 244,926 shares of our common stock.   

 

·In the August 6, 2009 registered direct offering, we sold shares of common stock and warrants exercisable for up to 2,995,305 shares of our common stock to investors and issued a warrant to purchase 577,666 shares of our common stock to Midtown, which acted as our exclusive placement agent for the August 2009 transaction.  

 

·In the transaction that closed on September 14, 2009, we sold an aggregate of 15,312,500 shares of our common stock and warrants exercisable for up to 5,053,125 shares of our common stock to investors and issued warrants to purchase up to 969,526 shares of our common stock to the two placement agents and a consultant in relation to the transaction.

 

·In the closings under the common stock purchase agreement that occurred in April, May and June 2010, we sold Seaside 12,000,000 shares of our common stock and issued to Midtown, as placement agent, warrants to purchase an aggregate of 300,000 shares of our common stock.

 

·In connection with the securities purchase agreement dated July 7, 2011 and option thereunder, we sold an aggregate of 2,575 shares of our Series A 9% Convertible Preferred Stock and issued warrants exercisable for up to 17,166,666 shares of our common stock to investors.

 

·In connection with the securities purchase agreement dated January 31, 2012, we sold an aggregate of 2,000 shares of our Series B 9% Convertible Preferred Stock and issued warrants exercisable for up to 13,333,333 shares of our common stock to investors.

 

·In connection with the securities purchase agreement dated August 8, 2012, we sold an aggregate of 750 shares of our Series C 9% Convertible Preferred Stock and issued warrants exercisable for up to 9,375,000 shares of our common stock to investors.

 

·In connection with the securities purchase agreement dated December 10, 2012, we sold an aggregate of 750 shares of our Series D 9% Convertible Preferred Stock and issued warrants exercisable for up to 24,999,999 shares of our common stock to investors.

 

·In connection with the securities purchase agreement dated June 17, 2013, we sold an aggregate of 1,225 shares of our Series E 9% Convertible Preferred Stock and issued warrants exercisable for up to 40,833,335 shares of our common stock to investors.

 

·In connection with the securities purchase agreement dated January 14, 2014, we sold an aggregate of 800 shares of our Series E 9% Convertible Preferred Stock and issued warrants exercisable for up to 26,666,668 shares of our common stock to investors.

 

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As of March 3, 2014, all of the warrants issued in the aforementioned registered direct offerings were exercisable.  At March 3, 2014, outstanding warrants issued in connection with the June, August and September 2009 registered direct offerings, the April, May and June 2010 sales to Seaside and the January to April 2011, February 2012, August 2012, December 2012, June 2013 and January 2014 private placements were as follows (after adjustment for anti-dilution provisions and subsequent exercises):

 

 

Date Issued  

Aggregate No. of

Shares Unexercised

   

Exercise

Price

  Expiration Date
June 15, 2009     8,470,661       0.76   December 15, 2014
                   
August 6, 2009     3,413,928       0.79   February 4, 2015
                   
September 14, 2009     5,157,813       1.00   March 15, 2015
                   
April 8, 2010     50,000       0.4726   February 9, 2015
                   
April 21, 2010     50,000       0.4258   February 9, 2015
                   
April 30, 2010     50,000       0.415   February 9, 2015
                   
May 14, 2010     50,000       0.3496   February 9, 2015
                   
May 28, 2010     50,000       0.351   February 9, 2015
                   
June 11, 2010     50,000       0.3543   February 9, 2015
                   
February 1, 2012*     5,675,227       0.03   February 1, 2017
                   
August 10, 2012*     4,999,999       0.03   August 10, 2017
                   
December 10, 2012*     8,324,144       0.03   December 10, 2017
                   
June 17, 2013*     34,166,669       0.03   June 17, 2018
                   
January 15, 2014*     26,666,668       0.03   January 15, 2019

 

*Upon issuance of securities at a price per share of common stock less than the then applicable exercise price, the warrants are subject to anti-dilution adjustment of the exercise price and to the number of shares of common stock that may be purchased upon exercise of each warrant such that the aggregate exercise price payable upon exercise of the warrant will be the same as the aggregate exercise price in effect immediately prior to such adjustment. Due to the anti-dilution adjustment provision of these warrants, they have been reclassified on Generex’s balance sheet as a liability under the caption “Derivative Warrant Liability” with any changes in fair value at each reporting period recorded in earnings in accordance with ASC 815.

 

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In addition, we may receive additional proceeds from the exercise of warrants issued in connection with the securities purchase agreement and related documents that we entered into on March 31, 2008 with existing institutional investors relating to a private placement of 8% secured convertible notes (the “Notes”) and warrants (the “Series Warrants”) for aggregate gross proceeds to us of $20,650,000.  As of June 1, 2009, the outstanding principal balance and accrued interest on the Notes were satisfied in full.

 

The Series Warrants issued in connection with the March 2008 securities purchase agreement included:

 

(i)Series A and A-1 Warrants, which are exercisable for a period of 7 years into an aggregate of 75% of the number of shares of our common stock initially issuable upon conversion of the Notes, with the Series A Warrants being exercisable into 5,257,729 shares immediately upon issuance and the Series A-1 warrants being exercisable into 7,541,857 shares as of October 1, 2008;

 

(ii)Series B Warrants, which became exercisable on October 1, 2008 into 100% of the shares of our common stock initially issuable upon conversion of the Notes (initially 17,066,166 shares) and remain exercisable for a period of 18 months after the registration statement covering the shares of common stock issuable upon conversion or exercise of the Notes and Warrants was declared effective by the SEC; and

 

(iii)Series C Warrants, which are exercisable for a period of 7 years as of October 1, 2008, but only to the extent that the Series B Warrant are exercised and only in the same percentage that the Series B Warrants are exercised, up to a maximum percentage of 75% of the number of shares of our common stock initially issuable upon conversion of the Notes (initially a maximum of 12,799,580 shares).

 

The initial exercise price of each Series Warrant was $1.21.  The Series Warrants include a cashless exercise feature. The exercise price of the Series Warrants was subsequently reduced initially to $0.50, then to $0.33, to $0.25, to $0.15, to $0.08 and currently to $0.03 as a result of a price protection provision triggered by our offering of stock in private placements in May 2009, January and July 2011 and February, August 2012 and December 2012.  This price protection feature allows for the reduction in the exercise price of the Series Warrants in the event we subsequently issue common stock or securities convertible into or exercisable for common stock, such as options and warrants, at a price per share less than the Series Warrant exercise price then in effect. In addition, with any reduction to the Series Warrant exercise price, the number of shares of common stock that may be purchased upon exercise of each Series Warrant will be increased or decreased proportionately, so that after such adjustment the aggregate Series Warrant exercise price payable for the adjusted number of shares issuable upon exercise will be the same as the aggregate Series Warrant exercise price in effect immediately prior to such adjustment. We account for these warrants with price protection in accordance with ASC 815 as described in Note 10 to the Notes to Consolidated Financial Statements included elsewhere in this registration statement.

 

As of March 3, 2014, outstanding Series Warrants were as follows (after adjustment for anti-dilution provisions and subsequent exercises):

 

Date Issued  

Aggregate No. of

Shares Unexercised

   

Exercise

Price*

  Expiration Date  
March 31, 2008     67,850,090     $ 0.03   March 31, 2016
                   
March 31, 2008     27,272,720     $ 0.03   September 30, 2016

 

*Upon issuance of securities at a price per share of common stock less than the then applicable exercise price, the warrants are subject to anti-dilution adjustment of the exercise price and to the number of shares of common stock that may be purchased upon exercise of each warrant such that the aggregate exercise price payable upon exercise of the warrant will be the same as the aggregate exercise price in effect immediately prior to such adjustment. Due to the anti-dilution adjustment provision of these warrants, they have been reclassified on Generex’s balance sheet as a liability under the caption “Derivative Warrant Liability” with any changes in fair value at each reporting period recorded in earnings in accordance with ASC 815.

 

Cash Flows for the Six months ended January 31, 2014

 

For the six months ended January 31, 2014, we used $1,663,625 in cash to fund our operating activities. The use for operating activities included a net loss of $2,656,196, changes to working capital including a decrease of $1,181 related to deferred revenue, a decrease related to other current assets of $5,617, offset by an increase of $51,665 related to accounts payable and accrued expenses,.

 

The use of cash was offset by non-cash expenses of $191,795 related to depreciation and amortization, stock-based compensation to executives, employees and directors of $262,871, stock-based compensation issued in exchange for services rendered by consultants of $207,000 and common stock issued for interest on our convertible preferred stock of $244,350. There was also a year-to-date non-cash loss of $230,557 related to the fair valuation of the derivative liabilities at January 31, 2014 and an accounting gain of $188,869 related to the sale of our remaining properties held for investment.

 

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We had net cash provided by investing activities of $849,106 in the six months ended January 31, 2014, representing primarily the net proceeds after real estate commissions of $883,780 related to the sale of the properties held for investment, offset by costs incurred for patents of $34,674.

 

We had cash provided by financing activities in the six months ended January 31, 2014 of $2,265,681, which pertained primarily to proceeds from cash exercises of warrants of $2,121,961 and net proceeds from the issuance of preferred stock of $750,000, offset by the discharge of long-term debt upon the sale of properties of $606,806.

 

Our net working capital at January 31, 2014 improved to negative $4,871,701 from negative $6,696,473 at July 31, 2013, which was attributed largely to proceeds from cash exercises of warrants and net proceeds from the Series E convertible preferred stock financing in January 2014, offset by our cash used in operations for the six-month period ended January 31, 2014.

 

Conversion of Outstanding Series A, Series B, Series C, Series D and Series E 9% Convertible Preferred Stock

 

All outstanding shares of our Series A 9% Convertible Preferred Stock were converted into shares of our common stock prior to the end of our fiscal year ended July 31, 2012. A total of 17,166,666 shares of common stock have been issued upon the conversion of 2,575 shares of Series A convertible preferred stock. Upon conversion, we paid the holders of the Series A convertible preferred stock a “make whole” payment equal to $270 per $1,000 of stated value of the Series A convertible preferred stock, less the amount of all prior quarterly dividends paid on such converted preferred stock before the relevant conversion date. We issued 6,129,666 additional shares of common stock on such conversions of the Series A convertible preferred stock. Dividends paid on the Series A Convertible Preferred Stock were $12,383 during the fiscal year ended July 31, 2012.

 

As of January 31, 2014, all of the 2,000 shares of our Series B 9% Convertible Preferred Stock had been converted into shares of our common stock. We issued 38,520,832 shares of common stock upon the conversion of the Series B convertible preferred stock and an additional 14,819,679 shares of common stock were issued as “make-whole payments” on such conversions.

 

As of January 31, 2014, all of the 750 shares of our Series C 9% Convertible Preferred Stock had been converted into shares of our common stock. We issued 22,916,665 shares of common stock upon the conversion of the Series C convertible preferred stock and an additional 6,664,863 shares of common stock were issued as “make-whole payments” on such conversions.

 

As of January 31, 2014, all of the 750 shares of our Series D 9% Convertible Preferred Stock had been converted into shares of our common stock. We issued 24,999,999 shares of common stock upon the conversion of the Series D convertible preferred stock and an additional 7,825,191 shares of common stock were issued as “make-whole payments” on such conversions.

 

As of January 31, 2014, 1,200 shares of our Series E 9% Convertible Preferred Stock had been converted into shares of our common stock. We issued 40,000,000 shares of common stock upon the conversion of the Series E convertible preferred stock and an additional 11,385,194 shares of common stock were issued as “make-whole payments” on such conversions.

 

Funding Requirements and Commitments

 

If we obtain necessary financing, we expect to devote substantial resources to obtaining regulatory approval of Generex Oral-lyn™ in the U.S., Canada and Europe and to commercializing Generex Oral-lyn™.  We may also devote resources to obtaining approval for the importation, marketing and commercialization of Generex Oral-lyn™ in other countries where we have licensed distributors.

 

Under the long-term agreement that we signed with sanofi-aventis in December 2009, sanofi-aventis will manufacture and supply recombinant human insulin to us in the territories specified in the agreement. Through this agreement, we will procure recombinant human insulin crystals for use in the production of Generex Oral-lyn™. The terms of the supply agreement required us to make certain minimum purchases of insulin from sanofi-aventis through the period ended December 31, 2011, which minimum purchases we did not satisfy. Sanofi-aventis will be our exclusive supplier in certain countries and a non-exclusive supplier in some other countries. Sanofi-aventis may delete any territory from the agreement in which Generex Oral-lyn™ has not been approved for commercial sale by December 31, 2011. The prices under the supply agreement are subject to adjustment beginning after December 31, 2012. As we did not meet the minimum purchase requirements by December 31, 2011, sanofi-aventis may terminate the agreement. Upon termination, we would be obligated to pay sanofi-aventis for all materials and components that it has acquired or ordered to manufacture insulin based on our forecasts or minimum purchase commitments, all related work-in-progress (at cost) and all finished insulin in inventory. We did not provide any forecasts to sanofi-aventis and have not included any accruals related to the purchase commitments in our interim financial statements as of January 31, 2014 or July 31, 2013, nor has sanofi-aventis terminated the agreement.

 

In addition to the resources that we will dedicate to regulatory approval and commercialization of Generex Oral-lyn™, we will expend resources on further clinical development of our immunotherapeutic vaccines.

 

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Our future funding requirements and commitments and our ability to raise additional capital will depend on factors that include:

 

  · the timing and amount of expense incurred to complete our clinical trials;

 

  · the costs and timing of the regulatory process as we seek approval of our products in development;

 

  · the advancement of our products in development;

 

  · our ability to generate new relationships with industry partners throughout the world that will provide us with regulatory assistance and long-term commercialization opportunities;

 

  · the timing, receipt and amount of sales, if any, from Generex Oral-lyn™ in India, Lebanon, Algeria and Ecuador;

 

  · the cost of manufacturing (paid to third parties) of our licensed products, and the cost of marketing and sales activities of those products;

 

  · the costs of prosecuting, maintaining, and enforcing patent claims, if any claims are made;

 

  · our ability to maintain existing collaborative relationships and establish new relationships as we advance our products in development;
     
  · our ability to obtain the necessary financing to fund our operations and effect our strategic development plan; and

 

  · the receptivity of the financial market to biopharmaceutical companies.

 

Off-Balance Sheet Arrangements

 

We have no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on the Company’s financial condition, changes in financial condition, revenue or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors, and we do not have any non-consolidated special purpose entities.

 

Certain Related Party Transactions

 

See Part III, Item 13 – Certain Relationships and Related Transactions, and Directors Independence in our Annual Report on Form 10-K for the year ended July 31, 2013, as amended, for further descriptions of our transactions with related parties during the last fiscal year.

 

Recently Adopted Accounting Pronouncements

 

In June 2011, the FASB issued guidance regarding the presentation of Comprehensive Income within financial statements. The guidance was effective for our annual fiscal period ended July 31, 2013. The adoption of this guidance did not have a significant impact on our consolidated financial statements.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

 

We are exposed to market risks associated with changes in the exchange rates between U.S. and Canadian currencies and with changes in the interest rates related to our fixed rate debt. We do not believe that any of these risks will have a material impact on our financial condition, results of operations and cash flows.

 

At the present time, we maintain our cash in short-term government or government guaranteed instruments, short-term commercial paper, and interest bearing bank deposits or demand bank deposits which do not earn interest. A substantial majority of these instruments and deposits are denominated in U.S. dollars, with the exception of funds denominated in Canadian dollars on deposit in Canadian banks to meet short-term operating needs in Canada. We do not presently employ any hedging or similar strategy intended to mitigate against losses that could be incurred as a result of fluctuations in the exchange rates between U.S. and Canadian currencies.

 

As of January 31, 2014, we did not have any fixed rate debt. We have neither issued nor own any long-term debt instruments, or any other financial instruments, for trading purposes to which we would be subject to material market risks.

 

We have warrants outstanding with price protection provisions that allow for the reduction in the exercise price of the warrants in the event we subsequently issue common stock or securities convertible into or exercisable for common stock, such as options and warrants, at a price per share less than the warrant exercise price then in effect. In addition, with any reduction to the warrant exercise price, the number of shares of common stock that may be purchased upon exercise of each warrant will be increased proportionately, so that after such adjustment the aggregate warrant exercise price payable for the adjusted number of shares issuable upon exercise will be the same as the aggregate warrant exercise price in effect immediately prior to such adjustment. We account for the warrants with price protection in accordance with FASB ASC 815. We recognize the warrants with price protection in our consolidated balance sheet as liabilities. The warrant liability is revalued at each reporting period and changes in fair value are recognized currently in the consolidated statements of operations under the caption Change in fair value of derivative warrant liability. While the change in fair value of the derivative warrant liability has no effect on our cash flows, the gains or losses can have a significant impact on non-operating income and expenses and thus the net income or loss. As of January 31, 2014, there were 176,622,183 warrants outstanding subject to price protection provisions with an estimated fair value of $5,259,929 or $0.029 per warrant. If the estimated fair value of the warrants increases, there will be a corresponding non-operating expense equal to the change in the value of the liability. Likewise, if the estimated fair value of the warrants decreases, there will be a corresponding non-operating gain equal to the change in the value of the liability. There is a directly proportional relationship between the fair value of the warrants and the market price of the stock; therefore increases or decreases in the market price will lead to corresponding increases or decreases in the value of the warrant liability and result in losses or gains, respectively, on our consolidated statements of operations.

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 Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

 

Prior to the filing of this Quarterly Report on Form 10-Q, an evaluation was performed under the supervision of and with the participation of Generex’s management, including the Chief Executive Officer (“CEO”) and acting Chief Financial Officer (“CFO”), of the effectiveness of Generex’s disclosure controls and procedures. Based on the evaluation, the CEO and CFO have concluded that, as of January 31, 2014, the Company’s disclosure controls and procedures are effective to ensure that information required to be disclosed by the Company in reports that it files or submits under the Exchange Act, is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and is accumulated and communicated to the Company’s management, as appropriate, to allow timely decisions regarding required disclosure.

 

Changes in Internal Control over Financial Reporting

 

During the fiscal quarter ended January 31, 2014, there were no changes in Generex’s internal controls over financial reporting that have materially affected, or are reasonably likely to materially affect, Generex’s internal control over financial reporting.

 

 

PART II - OTHER INFORMATION

 

Item 1. Legal Proceedings.

 

See Note 6 – Pending Litigation of the Notes to the Consolidated Financial Statements set forth under Item 1 of Part I of this Quarterly Report for a description of legal proceedings in which we are currently involved.

 

We are involved in certain other legal proceedings in addition to those specifically described in this Quarterly Report. Subject to the uncertainty inherent in all litigation, we do not believe at the present time that the resolution of any of these legal proceedings is likely to have a material adverse effect on our financial position, operations or cash flows.

 

With respect to all litigation matters, as additional information concerning the estimates used by us becomes known, we reassess each matter’s position both with respect to accrued liabilities and other potential exposures.

 

Item 1A. Risk Factors.

 

In addition to the other information included in this Quarterly Report on Form 10-Q, you should carefully review and consider the factors discussed in Part I, Item 1A - Risk Factors of our Annual Report on Form 10-K for the year ended July 31, 2013, as amended, certain of which have been updated below. These factors materially affect our business, financial condition or future results of operations. The risks, uncertainties and other factors described in our Annual Report on Form 10-K and below are not the only ones facing our company. Additional risks, uncertainties and other factors not presently known to us or that we currently deem immaterial may also impair our business operations, financial condition or operating results. Any of the risks, uncertainties and other factors could cause the trading price of our common stock to decline substantially.

 

Risks Related to Our Financial Condition

 

We will require additional financing to continue our operations.

 

As of January 31, 2014, our current cash position is not sufficient to meet our working capital needs for the next twelve months based on the pace of our planned activities. To continue operations, we will require additional funds to support our working capital requirements and any expansion or other activities, or will need to significantly reduce our clinical trials and other planned activities or suspend operations. Management is seeking various alternatives to ensure that we can meet some of our operating cash flow requirements through financing activities, such as private placement of our common stock, preferred stock offerings and offerings of debt and convertible debt instruments as well as through merger or acquisition opportunities. The securities purchase agreements that we entered into on June 17, 2013 and January 14, 2014 with certain investors limits the financing activities that we may undertake in the near future as it prohibits us from (i) issuing additional equity securities until 60 days after the effective date of a registration statement covering the resale of the common stock issuable upon exercise of the warrants and conversion of the preferred stock sold in each transaction and (ii) issuing additional debt or equity securities with a variable conversion or exercise price until June 17, 2014 and January 14, 2015, respectively. In addition, management is actively seeking strategic alternatives, including strategic investments and divestitures. Management has sold non-essential real estate assets which were classified as Assets Held for Investment to augment its cash position.

 

31
 

We cannot provide any assurance that we will obtain the required funding. Our inability to obtain required funding in the near future or our inability to obtain funding on favorable terms will have a material adverse effect on our operations and our strategic development plan for future growth. If we cannot successfully raise additional capital and implement our strategic development plan, our liquidity, financial condition and business prospects will be materially and adversely affected and we may have to cease operations.

 

We have a history of losses and will incur additional losses.

 

We are a development stage company with a limited history of operations, and do not expect sufficient revenues to support our operation in the immediately foreseeable future. We do not expect to receive significant revenues in Ecuador, Algeria and Lebanon where we have been approved for commercial sale in the next twelve months. While we have entered into a licensing and distribution agreement with a leading Indian-based pharmaceutical company and insulin distributor, we do not anticipate recognizing significant revenue from sales of Generex Oral-lyn™ in India in the next twelve months, as our Indian partner has to receive marketing approval of a completed in-country clinical study before the product can be offered for commercial sale in India.

 

To date, we have not been profitable and our accumulated net loss available to shareholders was $370,953,051 at January 31, 2014. Our losses have resulted principally from costs incurred in research and development, including clinical trials, and from general and administrative costs associated with our operations. While we seek to attain profitability, we cannot be sure that we will ever achieve product and other revenue sufficient for us to attain this objective.

 

With the exception of Generex Oral-lyn™, which has received regulatory approval in Ecuador, India (subject to marketing approval of an in-country clinical study), Lebanon and Algeria, our product candidates are in research or early stages of pre-clinical and clinical development. We will need to conduct substantial additional research, development and clinical trials. We will also need to receive necessary regulatory clearances both in the United States and foreign countries and obtain meaningful patent protection for and establish freedom to commercialize each of our product candidates. We must also complete further clinical trials and seek regulatory approvals for Generex Oral-lyn™ in countries outside of Ecuador, India, Lebanon and Algeria. We cannot be sure that we will obtain required regulatory approvals, or successfully research, develop, commercialize, manufacture and market any other product candidates. We expect that these activities, together with future general and administrative activities, will result in significant expenses for the foreseeable future.

 

Our independent auditors have expressed substantial doubt about our ability to continue as a going concern as of July 31, 2013.

 

To date, we have not been profitable and our accumulated net loss available to shareholders was $370,953,051 at January 31, 2014, and our consolidated balance sheet reflected a stockholders’ deficiency of $8,077,689 at that date. We received a report from our independent auditors for the year ended July 31, 2013 that included an explanatory paragraph describing an uncertainty as to Generex’s ability to continue as a going concern. We must secure financing to continue our operations.

 

Due to material weaknesses in our internal controls over financial reporting, our internal controls were determined not to be effective for the prior fiscal year ended July 31, 2012. Our disclosure controls and procedures and internal controls over financial reporting may not be effective in future periods as a result of existing or newly identified material weaknesses in internal controls.

 

Effective internal controls are necessary for us to provide reasonable assurance with respect to our financial reports and to effectively prevent fraud. If we cannot provide reasonable assurance with respect to our financial reports and effectively prevent fraud, our reputation and operating results could be harmed. Pursuant to the Sarbanes-Oxley Act of 2002, we are required to furnish a report by management on internal control over financial reporting, including management’s assessment of the effectiveness of such control. Internal control over financial reporting may not prevent or detect misstatements because of its inherent limitations, including the possibility of human error, the circumvention or overriding of controls, or fraud. Therefore, even effective internal controls can provide only reasonable assurance with respect to the preparation and fair presentation of financial statements. In addition, projections of any evaluation of effectiveness of internal control over financial reporting to future periods are subject to the risk that the control may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. If we fail to maintain the adequacy of our internal controls, including any failure to implement required new or improved controls, or if we experience difficulties in their implementation, our business and operating results could be adversely impacted, we could fail to meet our reporting obligations, and our business and stock price could be adversely affected.

 

At July 31, 2012, our Chief Executive Officer and Chief Financial Officer evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) and concluded that, subject to the inherent limitations identified in Item 9A of Part II of the Form 10-K filed on October 15, 2012, our disclosure controls and procedures were not effective due to the existence of material weaknesses in our internal control over financial reporting because of inadequate segregation of duties over authorization, review and recording of transactions, as well as the financial reporting of such transactions. Our independent auditors issued an adverse attestation report regarding the effectiveness of the Company’s internal control over financial reporting at July 31, 2012.

 

32
 

We believe we have taken appropriate and reasonable steps to make the necessary improvements to remediate these deficiencies, however we cannot be certain that our remediation efforts will ensure that our management designs, implements and maintains adequate controls over our financial processes and reporting in the future or that the changes made will be sufficient to address and eliminate the material weaknesses previously identified. Our inability to remedy any additional deficiencies or material weaknesses that may be identified in the future could, among other things, have a material adverse effect on our business, results of operations and financial condition, as well as impair our ability to meet our quarterly, annual and other reporting requirements under the Securities Exchange Act of 1934 in a timely manner, and require us to incur additional costs or to divert management resources.

 

Risks Related to the Market for Our Common Stock

 

Our stock price is below $5.00 per share and is treated as a “penny stock”, which places restrictions on broker-dealers recommending the stock for purchase.

 

Our common stock is defined as “penny stock” under the Securities Exchange Act of 1934, as amended, which we refer to as the Exchange Act, and the rules promulgated thereunder. The SEC has adopted regulations that define “penny stock” to include common stock that has a market price of less than $5.00 per share, subject to certain exceptions. These rules include the following requirements:

 

·broker-dealers must deliver, prior to the transaction a disclosure schedule prepared by the SEC relating to the penny stock market;
·broker-dealers must disclose the commissions payable to the broker-dealer and its registered representative;
·broker-dealers must disclose current quotations for the securities;
·if a broker-dealer is the sole market-maker, the broker-dealer must disclose this fact and the broker-dealers presumed control over the market; and
·a broker-dealer must furnish its customers with monthly statements disclosing recent price information for all penny stocks held in the customer’s account and information on the limited market in penny stocks.

 

Additional sales practice requirements are imposed on broker-dealers who sell penny stocks to persons other than established customers and accredited investors. For these types of transactions, the broker-dealer must make a special suitability determination for the purchaser and must have received the purchaser’s written consent to the transaction prior to sale. If our common stock remains subject to these penny stock rules these disclosure requirements may have the effect of reducing the level of trading activity in the secondary market for our common stock. As a result, fewer broker-dealers may be willing to make a market in our stock, which could affect a shareholder’s ability to sell their shares.

 

The price of our common stock may be affected by a limited trading volume, may fluctuate significantly and may not reflect the actual value of our business.

 

There may be a limited public market for our common stock on the over the counter bulletin board market, and there can be no assurance that an active trading market will continue. An absence of an active trading market could adversely affect our stockholders’ ability to sell our common stock in short time periods, or at all. Our common stock has experienced, and is likely to experience in the future, significant price and volume fluctuations that could adversely affect the market price of our common stock without regard to our operating performance. In addition, we believe that factors, such as our sale of securities in connection with capital raising activities, changes in the overall economy and the volatility of the financial markets, could cause the price of our common stock to fluctuate substantially. Thus, the price at which shares of our common stock may trade from time to time may not reflect the actual value of our business or the actual value of our common stock.

 

Our recent equity financing will dilute current stockholders and could prevent the acquisition or sale of our business.

 

The equity financing transactions into which we have recently entered have and will dilute current stockholders. At January 31, 2014, there were 194,164,585 shares of common stock issuable upon exercise of the warrants that we issued in a private placement in March 2008, in the registered direct offerings conducted in June, August and September 2009, in connection with the sales to Seaside 88, LP in April, May and June 2010 and in the registered direct offerings in February 2012, August 2012, December 2012, June 2013 and January 2014. In addition, in connection with the private placements that closed on June 17, 2013 and January 14, 2014, an additional 27,500,001 shares of common stock are issuable upon conversion of the remaining Series E 9% Convertible Preferred Stock at January 31, 2014. Together the shares of common stock issuable upon exercise or conversion of the above-mentioned warrants and preferred stock represent approximately 32% of the shares of common stock currently outstanding.   Assuming the holders of the warrants convert and exercise all of the warrants into shares of common stock, the number of shares of issued and outstanding common stock will increase significantly, and current stockholders will own a smaller percentage of the outstanding common stock of Generex. The issuance of shares of common stock pursuant to the warrants will also have a dilutive effect on earnings per share and may adversely affect the market price of the common stock.

 

33
 

In addition, the issuance of shares of common stock upon exercise of the warrants issued in the March 2008 private placement, the registered direct offerings in June, August and September 2009 and in connection with the sales to Seaside in April, May and June 2010 and the private placements in February 2012, August 2012, December 2012, June 2013 and January 2014, could have an anti-takeover effect because such issuance will make it more difficult for, or discourage an attempt by, a party to obtain control of Generex by tender offer or other means. The issuance of common stock upon the exercise of the warrants or conversion of convertible preferred stock will increase the number of shares entitled to vote, increase the number of votes required to approve a change of control of the company, and dilute the interest of a party attempting to obtain control of the company.

 

If we raise funds through one or more additional equity financings in the future, it will have a further dilutive effect on existing holders of our shares by reducing their percentage ownership. The shares may be sold at a time when the market price is low because we are in need of the funds. This will dilute existing holders more than if our stock price was higher. In addition, equity financings normally involve shares sold at a discount to the current market price. Most of our outstanding warrants have price protection provisions, which decrease the exercise price of the warrant and increase the number of shares which may be purchased upon exercise of the warrants, if we sell additional equity at an effective price per common share less than the current exercise price of the warrant. Therefore, equity financings at a low price per share will result in even more dilution to existing shareholders.

 

 

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

 

In the fiscal quarter ended January 31, 2014, we sold, or have entered into commitments to issue, common stock and other securities in transactions in reliance upon exemptions from the registration requirements of the Securities Act.

 

We have issued or committed to issue shares of our common stock to Joseph Moscato, a consultant, pursuant to an agreement to provide us with investor relation services through September 30, 2014.   During the three months ended January 31, 2014, we issued or committed to issue 450,000 shares of common stock to Joseph Moscato pursuant to the consulting agreement. The sale of such shares was exempt from registration under the Securities Act in reliance upon Section 4(2) thereof. We believe that Joseph Moscato is an “accredited investor” as that term is defined in Rule 501(a) of Regulation D under the Securities Act. The certificates issued for the shares of common stock included a legend to indicate that they are restricted. The sales of such securities did not involve the use of underwriters, and no commissions were paid in connection therewith.

 

Issuer Purchases of Equity Securities

 

Neither Generex nor any affiliated purchaser (as defined in Section 240.10 b-18(a)(3) of the Exchange Act) purchased any of its equity securities during the fiscal quarter ended January 31, 2014.

 

Item 3. Defaults Upon Senior Securities.

 

None.

 

Item 5. Other Information.

 

Reference is made to the disclosure set forth under Part II, Item 2 - Unregistered Sales of Equity Securities and Use of Proceeds under the caption Unregistered Sales of Equity Securities in this Quarterly Report on Form 10-Q, which is incorporated by reference herein.

 

Item 6. Exhibits.

 

Exhibits are incorporated herein by reference or are filed with this quarterly report as set forth in the Exhibit Index beginning on page 36 hereof.

 

34
 

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.

 

  GENEREX BIOTECHNOLOGY CORPORATION
  (Registrant)
     
Date: March 7, 2014 By: /s/ Mark A. Fletcher
    Mark A. Fletcher
    President and Chief Executive Officer
     
Date: March 7, 2014 By: /s/ Stephen Fellows
    Stephen Fellows
    Chief Financial Officer
35
 

  

EXHIBIT INDEX

 

Exhibit

Number

  Description of Exhibit(1)
     
1   Amendment dated as of April 7, 2010 to Placement Agent Agreement Placement Agency Agreement, dated June 8, 2009, by and between Generex Biotechnology Corporation and Midtown Partners & Co., LLC and amendments dated August 5, August 18, and September 11, 2009 (incorporated by reference to Exhibit 1.2 to Generex Biotechnology Corporation’s Current Report on Form 8-K filed on April 8, 2010)
     
2   Agreement and Plan of Merger among Generex Biotechnology Corporation, Antigen Express, Inc. and AGEXP Acquisition Inc. (incorporated by reference to Exhibit 2.1 to Generex Biotechnology Corporation’s Current Report on Form 8-K filed on August 15, 2003)
     
3(i)(a)   Restated Certificate of Incorporation of Generex Biotechnology Corporation (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Post-Effective Amendment No. 1 to the Registration Statement on Form S-8 filed on October 26, 2009)
     
3(i)(b)  

Certificate of Designation of Preferences, Rights and Limitations of Series A 9% Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to Generex Biotechnology Corporation’s Current Report on Form 8-K filed on July 11, 2011).

 

3(i)(c)

 

 

 

Certificate of Designation of Preferences, Rights and Limitations of Series B 9% Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to Generex Biotechnology Corporation’s Current Report on form 8-K filed on February 1, 2012)

 

3(i)(d)  

Certificate of Designation of Preferences, Rights and Limitations of Series C 9% Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to Generex Biotechnology Corporation’s Current Report on Form 8-K filed on August 8, 2012).

 

3(i)(e)

 

 

Certificate of Designation of Preferences, Rights and Limitations of Series D 9% Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to Generex Biotechnology Corporation’s Current Report on form 8-K filed on December 11, 2012)

 

3(i)(f)

 

 

Certificate of Amendment to Restated Certificate of Incorporation of Generex Biotechnology Corporation (incorporated by reference to Exhibit 3(i)(f) to Generex Biotechnology Corporation’s Current Report on Registration Statement on Form S-1 (File No. 333-187656) filed on April 1, 2013)

 

3(i)(g)

 

 

Certificate of Designation of Preferences, Rights and Limitations of Series E 9% Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to Generex Biotechnology Corporation’s Current Report on form 8-K filed on June 17, 2013)

 

3(ii)   Amended and Restated By-Laws of Generex Biotechnology Corporation (incorporated by reference to Exhibit 3.2(ii) to Generex Biotechnology Corporation’s Report on Form 8-K filed December 5, 2007)
     
4.1   Form of Common Stock Certificate (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Registration Statement on Form S-1 (File No. 333-82667) filed on July 12, 1999)
     
4.2.1   Form of Securities Purchase Agreement entered into with Cranshire Capital, L.P.; Gryphon Partners, L.P.; Langley Partners, L.P.; Lakeshore Capital, Ltd.; LH Financial; Omicron Capital; Photon Fund, Ltd.; Howard Todd Horberg and Vertical Ventures, LLC dated May 29, 2003 (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 10-Q/A for the quarter ended October 31, 2003 filed on August 13, 2003)
     
4.2.2   Form of Registration Rights Agreement entered into with Cranshire Capital, L.P.; Gryphon Partners, L.P.; Langley Partners, L.P.; Lakeshore Capital, Ltd.; LH Financial; Omicron Capital; Photon Fund, Ltd.; Howard Todd Horberg and Vertical Ventures, LLC dated May 29, 2003 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 10-Q/A for the quarter ended October 31, 2003 filed on August 13, 2003)
     
4.2.3   Form of Warrant granted to Cranshire Capital, L.P.; Gryphon Partners, L.P.; Langley Partners, L.P.; Lakeshore Capital, Ltd.; LH Financial; Omicron Capital; Photon Fund, Ltd.; Howard Todd Horberg and Vertical Ventures, LLC dated May 29, 2003 (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 10-Q/A for the quarter ended October 31, 2003 filed on August 13, 2003)
     
4.3   Form of replacement Warrant issued to warrant holders exercising at reduced exercise price in May and June 2003 (incorporated by reference to Exhibit 4.13.7 to Generex Biotechnology Corporation’s Report on Form 10-K for the period ended July 31, 2003 filed on October 29, 2003)
     
4.4.1   Securities Purchase Agreement, dated December 19, 2003, by and among Generex Biotechnology Corporation and the investors named therein (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K/A filed on March 24, 2004)
     
4.4.2   Registration Rights Agreement, dated December 19, 2003, by and among Generex Biotechnology Corporation and the investors named therein (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K/A filed on March 24, 2004)
     
4.4.3   Form of Warrant issued in connection with Exhibit 4.4.1 (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K/A filed on March 24, 2004)
     
4.4.4   Form of Additional Investment Right issued in connection with Exhibit 4.4.1 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K/A filed on March 24, 2004)
     
4.5.1   Securities Purchase Agreement, dated January 7, 2004, by and between Generex Biotechnology Corporation and ICN Capital Limited (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
4.5.2   Registration Rights Agreement, dated January 7, 2004, by and between Generex Biotechnology Corporation and ICN Capital Limited (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.5.3   Warrant issued in connection with Exhibit 4.5.1 (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.5.4   Additional Investment Right issued in connection with Exhibit 4.5.1 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.6.1   Securities Purchase Agreement, dated January 9, 2004, by and between Generex Biotechnology Corporation and Vertical Ventures, LLC (incorporated by reference to Exhibit 4.5 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.6.2   Registration Rights Agreement, dated January 9, 2004, by and between Generex Biotechnology Corporation and Vertical Ventures, LLC (incorporated by reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.6.3   Warrant issued in connection with Exhibit 4.6.1 (incorporated by reference to Exhibit 4.7 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.6.4   Additional Investment Right issued in connection with Exhibit 4.6.1 (incorporated by reference to Exhibit 4.8 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.7.1   Securities Purchase Agreement, dated February 6, 2004, by and between Generex Biotechnology Corporation and Alexandra Global Master Fund, Ltd. (incorporated by reference to Exhibit 4.9 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.7.2   Registration Rights Agreement, dated February 6, 2004, by and between Generex Biotechnology Corporation and Alexandra Global Master Fund, Ltd. (incorporated by reference to Exhibit 4.10 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.7.3   Warrant issued in connection with Exhibit 4.7.1 (incorporated by reference to Exhibit 4.11 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.7.4   Additional Investment Right issued in connection with Exhibit 4.7.1 (incorporated by reference to Exhibit 4.12 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.7.5   Escrow Agreement, dated February 26, 2004, by and among Generex Biotechnology Corporation, Eckert Seamans Cherin & Mellott, LLC and Alexandra Global Master Fund, Ltd. (incorporated by reference to Exhibit 4.13 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.8.1   Securities Purchase Agreement, dated February 11, 2004, by and between Generex Biotechnology Corporation and Michael Sourlis (incorporated by reference to Exhibit 4.14 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.8.2   Registration Rights Agreement, dated February 11, 2004, by and between Generex Biotechnology Corporation and Michael Sourlis (incorporated by reference to Exhibit 4.15 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.8.3   Additional Investment Right issued in connection with Exhibit 4.8.1 (incorporated by reference to Exhibit 4.17 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.9.1   Securities Purchase Agreement, dated February 13, 2004, by and between Generex Biotechnology Corporation and Zapfe Holdings, Inc. (incorporated by reference to Exhibit 4.18 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.9.2   Registration Rights Agreement, dated February 13, 2004, by and between Generex Biotechnology Corporation and Zapfe Holdings, Inc. (incorporated by reference to Exhibit 4.19 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.9.3   Warrant issued in connection with Exhibit 4.9.1 (incorporated by reference to Exhibit 4.20 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.9.4   Additional Investment Right issued in connection with Exhibit 4.9.1 (incorporated by reference to Exhibit 4.21 Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2004)
     
4.10.1   Securities Purchase Agreement, dated June 23, 2004, by and among Generex Biotechnology Corporation and the investors named therein (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on July 14, 2004)
     
4.10.2   Registration Rights Agreement, dated June 23, 2004, by and among Generex Biotechnology Corporation and the investors (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on July 14, 2004)
     
4.10.3   Form of Warrant issued in connection with Exhibit 4.10.1 (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on July 14, 2004)
     
4.10.4   Form of Additional Investment Right issued in connection Exhibit 4.10.1 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on July 14, 2004)
     
4.11.1   Securities Purchase Agreement, dated November 10, 2004, by and among Generex Biotechnology Corporation and the investors named therein (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on November 12, 2004)
     
4.11.2   Form of 6% Secured Convertible Debenture issued in connection with Exhibit 4.11.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on November 12, 2004)
     
4.11.3   Registration Rights Agreement, dated November 10, 2004, by and among Generex Biotechnology Corporation and the investors named therein (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on November 12, 2004)
     
4.11.4   Form of Voting Agreement entered into in connection with Exhibit 4.11.1 (incorporated by reference to Exhibit 4.7 to Generex Biotechnology Corporation’s Report on Form 8-K filed on November 12, 2004)
     
4.12   Warrant issued to The Aethena Group, LLC on April 28, 2005 (incorporated by reference to Exhibit 4.20 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on June 14, 2005)
     
4.13.1   Amendment No. 4 to Securities Purchase Agreement and Registration Rights Agreement entered into by and between Generex Biotechnology Corporation and the Purchasers listed on the signature pages thereto on January 19, 2006 (incorporated by reference herein to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on January 20, 2006)
     
4.13.2   Form of Additional AIRs issued in connection with Exhibit 4.13.1 (incorporated by reference herein to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on January 20, 2006)
     
4.14   Form of Warrant issued by Generex Biotechnology Corporation on January 23, 2006 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on January 24, 2006)
     
4.15.1   Agreement to Amend Warrants between Generex Biotechnology Corporation and Cranshire Capital L.P. dated February 27, 2006 (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on February 28, 2006).
     
4.15.2   Agreement to Amend Warrants between Generex Biotechnology Corporation and Omicron Master Trust dated February 27, 2006 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on February 28, 2006).
     
4.15.3   Agreement to Amend Warrants between Generex Biotechnology Corporation and Iroquois Capital L.P. dated February 27, 2006 (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on February 28, 2006).
     
4.15.4   Agreement to Amend Warrants between Generex Biotechnology Corporation and Smithfield Fiduciary LLC dated February 27, 2006 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on February 28, 2006).
     
4.15.5   Form of Warrant issued by Generex Biotechnology Corporation on February 27, 2006 (incorporated by reference to Exhibit 4.26 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 16, 2006)

 

4.16.1   Agreement to Amend Additional Investment Right between Generex Biotechnology Corporation and Cranshire Capital, L.P. dated February 28, 2006 (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2006).
     
4.16.2   Agreement to Amend Additional Investment Right between Generex Biotechnology Corporation and Omicron Master Trust dated February 28, 2006 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2006).
     
4.16.3   Agreement to Amend Additional Investment Right between Generex Biotechnology Corporation and Iroquois Capital LP dated February 28, 2006 (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2006).
     
4.16.4   Agreement to Amend Additional Investment Right between Generex Biotechnology Corporation and Smithfield Fiduciary LLC dated February 28, 2006 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 1, 2006).
     
4.16.5   Form of Additional AIR Debenture issued by Generex Biotechnology Corporation on February 28, 2006 (incorporated by reference to Exhibit 4.31 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 16, 2006)
     
4.16.6   Form of Additional AIR Warrant issued by Generex Biotechnology Corporation on February 28, 2006 (incorporated by reference to Exhibit 4.32 to Generex Biotechnology Corporation’s Report on Form 10-K filed on October 16, 2006)
     
4.17.1   Form of Agreement to Amend Warrants between Generex Biotechnology Corporation and the Investors dated March 6, 2006 (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 7, 2006).
     
4.17.2   Form of Warrant issued by Generex Biotechnology Corporation on March 6, 2006 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on March 7, 2006)
     
4.18   Warrant issued by Generex Biotechnology Corporation on April 17, 2006 to Zapfe Holdings, Inc. (incorporated by reference to Exhibit 4.33 to Generex Biotechnology Corporation’s Report on Form 10-Q filed on June 14, 2006)
     
4.19   Form of Warrant issued by Generex Biotechnology Corporation on April 17, 2006 to certain employees (incorporated by reference to Exhibit 4.34 to Generex Biotechnology Corporation’s Report on Form 10-Q filed on June 14, 2006).
     
4.20.1   Securities Purchase Agreement entered into by and between Generex Biotechnology Corporation and four Investors on June 1, 2006 (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on June 2, 2006)
     
4.20.2   Form of Warrant issued by Generex Biotechnology Corporation on June 1, 2006 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on June 2, 2006)
     
4.21.1   Form of Amendment to Outstanding Warrants (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on June 2, 2006)
     
4.21.2   Form of Warrant issued by Generex Biotechnology Corporation on June 1, 2006 in connection with Exhibit 4.39 (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Report on Form 8-K filed on June 2, 2006)
     
4.22.1   Securities Purchase Agreement, dated as of March 31, 2008 among the Registrant and each of the purchasers named therein (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on April 2, 2008)
     
4.22.2   Form of 8% Secured Convertible Note, as amended (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Registration Statement (333-150562) on Form S-3 filed on October 31, 2008)
     
4.22.3   Form of Series A Warrant, as amended (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Registration Statement on Form S-3 (333-150562) filed on October 31, 2008)
     
4.22.4   Form of Series A-1 Warrant, as amended (incorporated by reference to Exhibit 4.4 to Generex Biotechnology Corporation’s Registration Statement on Form S-3 (333-150562) filed on October 31, 2008)
     
4.22.5   Form of Series B Warrant, as amended (incorporated by reference to Exhibit 4.5 to Generex Biotechnology Corporation’s Registration Statement on Form S-3 (333-150562) filed on October 31, 2008)
     
4.22.6   Form of Series C Warrant, as amended (incorporated by reference to Exhibit 4.6 to Generex Biotechnology Corporation’s Registration Statement on Form S-3 (333-150562) filed on October 31, 2008)
     
4.22.7   Registration Rights Agreement, dated March 31, 2008, among Registrant and each of the purchasers under Securities Purchase Agreement (incorporated by reference to Exhibit 4.7 to Generex Biotechnology Corporation’s Report on Form 8-K filed on April 2, 2008)
     
4.22.8   Security Agreement (incorporated by reference to Exhibit 4.8 to Generex Biotechnology Corporation’s Report on Form 8-K filed on April 2, 2008)
     
4.22.9   Form of Guaranty (incorporated by reference to Exhibit 4.9 to Generex Biotechnology Corporation’s Report on Form 8-K filed on April 2, 2008)
     
4.23.1   Form of Securities Purchase Agreement, dated May 15, 2009, entered into between Generex Biotechnology Corporation and each investor in the offering (incorporated by reference to Exhibit 1.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on May 18, 2009)
     
4.24.1   Form of Securities Purchase Agreement, dated June 15, 2009, entered into between Generex Biotechnology Corporation and each investor in the offering (incorporated by reference to Exhibit 10.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on June 16, 2009)
     
4.24.2  

Form of Warrant issued in connection with Exhibit 4.24.1 (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on June 16, 2009)

 

4.24.3   Form of Warrant issued to Midtown Partners & Co., LLC in connection with Exhibit 4.24.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on June 16, 2009)
     
4.25.1   Form of Securities Purchase Agreement, dated August 6, 2009, entered into between Generex Biotechnology Corporation and each investor in the offering (incorporated by reference to Exhibit 10.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on August 6, 2009)
     
4.25.2   Form of Warrant issued in connection with Exhibit 4.25.1 (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on August 6, 2009)
     
4.25.3   Form of Warrant issued to Midtown Partners & Co., LLC in connection with Exhibit 4.25.1 (incorporated by reference to Exhibit 4.28 to Generex Biotechnology Corporation’s Report on Form 8-K filed on August 6, 2009)
     
4.26.1   Form of Securities Purchase Agreement, dated September 11, 2009, entered into between Generex Biotechnology Corporation and each investor in the offering (incorporated by reference to Exhibit 10.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on September 15, 2009)
     
4.26.2   Form of Warrant issued in connection with Exhibit 4.26.1 (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on September 15, 2009)
     
4.26.3   Form of Warrant issued to Midtown Partners & Co., LLC in connection with Exhibit 4.26.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on September 15, 2009)
     
4.27.1   Common Stock Purchase Agreement dated April 7, 2010 by and between Generex Biotechnology Corporation and Seaside 88, LP. (incorporated by reference to Exhibit 10.1 to Generex Biotechnology Corporation’s Report on Form  8-K filed on April 8, 2010)
     
4.27.2   First Amendment to Common Stock Purchase Agreement dated April 28, 2010 by and between Generex Biotechnology Corporation and Seaside 88, LP. (incorporated by reference to Exhibit 10.1 to Generex Biotechnology Corporation’s Report on Form  8-K filed on April 29, 2010)
     
4.27.3   Form of Warrant issued to Midtown Partners & Co., LLC in connection with the Placement Agency Agreement and in connection with Exhibit 4.27.1 hereto (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on April 8, 2010)
     
4.28.1   Form of Securities Purchase Agreement, dated January 24, 2011, entered into between Generex Biotechnology Corporation and each investor in the offering (incorporated by reference to Exhibit 10.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on January 25, 2011)
     

4.28.2

 

 

 

Form of Warrant issued in connection with Exhibit 4.28.1 (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Report on Form 8-K filed on January 25, 2011)

 

4.28.3

 

 

Amendment to Purchase Agreement dated March 25, 2011 (incorporated by reference to Exhibit 10.1 to Generex Biotechnology Corporation’s Current Report on Form 8-K filed on March 30, 2011).

 

4.28.4

 

 

Second Amendment to Purchase Agreement dated April 13, 2011 (incorporated by reference to Exhibit 10.1 to Generex Biotechnology Corporation’s Current Report on Form 8-K filed on April 14, 2011).

 

4.29.1

 

 

Form of Securities Purchase Agreement, dated July 8, 2011, by and among Generex Biotechnology Corporation and the purchaser(s) listed on the signature pages thereto (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Current Report on Form 8-K filed on July 11, 2011).

 

4.29.2

 

 

Form of Common Stock Warrant issued in connection with Exhibit 4.29.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Current Report on Form 8-K filed on July 11, 2011).

 

4.30.1  

Form of Securities Purchase Agreement, dated January 31, 2012, by and among Generex Biotechnology Corporation and the purchaser(s) listed on the signature pages thereto (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Current Report on Form 8-K filed on February 1, 2012).

 

4.30.2  

Form of Common Stock Warrant issued in connection with Exhibit 4.30.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on February 1, 2012).

 

4.30.3  

Form of Registration Rights Agreement by and among Generex Biotechnology Corporation and the purchaser(s) listed on the signature pages thereto (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on February 1, 2012)

 

4.31.1  

Form of Securities Purchase Agreement, dated August 8, 2012, by and among Generex Biotechnology Corporation and the purchaser(s) listed on the signature pages thereto (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Current Report on Form 8-K filed on August 8, 2012).

 

4.31.2  

Form of Common Stock Warrant issued in connection with Exhibit 4.30.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on August 8, 2012).

 

4.31.3  

Form of Registration Rights Agreement by and among Generex Biotechnology Corporation and the purchaser(s) listed on the signature pages thereto (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on August 8, 2012)

 

4.32.1  

Form of Securities Purchase Agreement, dated December 10, 2012, by and among Generex Biotechnology Corporation and the purchaser(s) listed on the signature pages thereto (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Current Report on Form 8-K filed on December 11, 2012).

 

4.32.2  

Form of Common Stock Warrant issued in connection with Exhibit 4.30.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on December 11, 2012).

 

4.32.3  

Form of Registration Rights Agreement by and among Generex Biotechnology Corporation and the purchaser(s) listed on the signature pages thereto (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on December 10, 2012)

 

4.33.1  

Form of Securities Purchase Agreement, dated June 17, 2013, by and among Generex Biotechnology Corporation and the purchaser(s) listed on the signature pages thereto (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Current Report on Form 8-K filed on June 17, 2013).

 

4.33.2  

Form of Common Stock Warrant issued in connection with Exhibit 4.33.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on June 17, 2013).

 

4.33.3  

Form of Registration Rights Agreement by and among Generex Biotechnology Corporation and the purchaser(s) listed on the signature pages thereto (incorporated by reference to Exhibit 4.3 to Generex Biotechnology Corporation’s Report on Form 8-K filed on June 17, 2013)

 

4.34.1  

Form of Securities Purchase Agreement, dated January 14, 2014, by and among Generex Biotechnology Corporation and the purchaser(s) listed on the signature pages thereto (incorporated by reference to Exhibit 4.1 to Generex Biotechnology Corporation’s Current Report on Form 8-K filed on January 14, 2014).

 

4.34.2  

Form of Common Stock Warrant issued in connection with Exhibit 4.34.1 (incorporated by reference to Exhibit 4.2 to Generex Biotechnology Corporation’s Report on Form 8-K filed on January 14, 2014).

 

10.1  

Nonqualified Stock Option Grant Agreement dated October 31, 2013 by and between Generex Biotechnology Corporation and James Anderson (incorporated by reference to Exhibit 10.1 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on December 9, 2013).*

 

10.2  

Nonqualified Stock Option Grant Agreement dated October 31, 2013 by and between Generex Biotechnology Corporation and John Barratt (incorporated by reference to Exhibit 10.2 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on December 9, 2013).*

 

10.3  

Nonqualified Stock Option Grant Agreement dated October 31, 2013 by and between Generex Biotechnology Corporation and David Brusegard (incorporated by reference to Exhibit 10.3 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on December 9, 2013).*

 

10.4  

Nonqualified Stock Option Grant Agreement dated October 31, 2013 by and between Generex Biotechnology Corporation and Stephen Fellows (incorporated by reference to Exhibit 10.4 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on December 9, 2013).*

 

10.5  

Nonqualified Stock Option Grant Agreement dated October 31, 2013 by and between Generex Biotechnology Corporation and Mark Fletcher (incorporated by reference to Exhibit 10.5 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on December 9, 2013).*

 

10.6  

Nonqualified Stock Option Grant Agreement dated October 31, 2013 by and between Generex Biotechnology Corporation and Brian McGee (incorporated by reference to Exhibit 10.6 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on December 9, 2013).*

 

10.7  

Nonqualified Stock Option Grant Agreement dated October 31, 2013 by and between Generex Biotechnology Corporation and Eric von Hofe (incorporated by reference to Exhibit 10.7 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on December 9, 2013).*

 

10.8  

Nonqualified Stock Option Grant Agreement dated October 31, 2013 by and between Generex Biotechnology Corporation and James Anderson (incorporated by reference to Exhibit 10.8 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on December 9, 2013).*

 

10.9  

Nonqualified Stock Option Grant Agreement dated October 31, 2013 by and between Generex Biotechnology Corporation and John Barratt (incorporated by reference to Exhibit 10.9 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on December 9, 2013).*

 

10.10  

Nonqualified Stock Option Grant Agreement dated October 31, 2013 by and between Generex Biotechnology Corporation and David Brusegard (incorporated by reference to Exhibit 10.10 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on December 9, 2013).*

 

10.11  

Nonqualified Stock Option Grant Agreement dated October 31, 2013 by and between Generex Biotechnology Corporation and Stephen Fellows (incorporated by reference to Exhibit 10.11 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on December 9, 2013).*

 

10.12  

Nonqualified Stock Option Grant Agreement dated October 31, 2013 by and between Generex Biotechnology Corporation and Mark Fletcher (incorporated by reference to Exhibit 10.12 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on December 9, 2013).*

 

10.13  

Nonqualified Stock Option Grant Agreement dated October 31, 2013 by and between Generex Biotechnology Corporation and Brian McGee (incorporated by reference to Exhibit 10.13 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on December 9, 2013).*

 

10.14  

Nonqualified Stock Option Grant Agreement dated October 31, 2013 by and between Generex Biotechnology Corporation and Eric von Hofe (incorporated by reference to Exhibit 10.14 to Generex Biotechnology Corporation’s Quarterly Report on Form 10-Q filed on December 9, 2013).*

 

31.1   Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
     
31.2   Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
     
32   Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

* Management contract or management compensatory plan or arrangement.

 

(1) In the case of incorporation by reference to documents filed by the Registrant under the Exchange Act, the Registrant’s file number under the Exchange Act is 000-25169.

36
 

EX-31.1 2 gnbt21914form10qex31_1.htm EXHIBIT 31.1

Exhibit 31.1

CERTIFICATION

 

I, Mark A. Fletcher, certify that:

 

  1.   I have reviewed this Quarterly Report on Form 10-Q for the period ended January 31, 2014 of Generex Biotechnology 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(e) 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, including its consolidated subsidiaries, 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 caused 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 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 a significant role in the registrant’s internal control over financial reporting.
             

 

DATE: March 7, 2014   By: /s/ Mark A. Fletcher
    Mark A. Fletcher
    President & Chief Executive Officer
    (Principal Executive Officer)

EX-31.2 3 gnbt21914form10qex31_2.htm EXHIBIT 31.2

Exhibit 31.2

CERTIFICATION

 

I, Stephen Fellows, certify that:

 

  1.   I have reviewed this Quarterly Report on Form 10-Q for the period ended January 31, 2014 of Generex Biotechnology 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(e) 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, including its consolidated subsidiaries, 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 caused 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 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 a significant role in the registrant’s internal control over financial reporting.
             

 

DATE: March 7, 2014   By: /s/ Stephen Fellows
    Stephen Fellows
    Chief Financial Officer
    (Principal Financial and Accounting Officer)

EX-32 4 gnbt21914form10qex32.htm EXHIBIT 32

Exhibit 32

 

CERTIFICATIONS

 

Pursuant to Section 906 of the Public Company Accounting Reform and Investor Protection Act of 2002 (18 U.S.C. ss. 1350, as adopted), Mark A. Fletcher, Chief Executive Officer and President of Generex Biotechnology Corporation (the "Company"), and Stephen Fellows, Acting Chief Financial Officer of the Company, each hereby certifies that, to the best of their knowledge:

 

1. The Company's Quarterly Report on Form 10-Q for the period ended January 31, 2014 to which this Certification is attached as Exhibit 32 (the "Report") fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

 

2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company at the end of the period covered by the Report.

 

 

DATE: March 7, 2014   By: /s/ Mark A. Fletcher
    Mark A. Fletcher
    President & Chief Executive Officer
    (Principal Executive Officer)

 

 

 

DATE: March 7, 2014   By: /s/ Stephen Fellows
    Stephen Fellows
    Chief Financial Officer
    (Principal Financial and Accounting Officer)

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Includes other kinds of accounts that have the general characteristics of demand deposits. Also includes short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Excludes cash and cash equivalents within disposal group and discontinued operation. Stock Option Plan 2001 [Member] Stock Option Plan 2006 [Member] Accounts Payable and Accrued Liabilities, Research and Development, Current Accrued Liabilities, Make Whole Payments On Convertible Preferred Stock, Current Commitment and Contingency [Axis] Commitment and Contingency [Domain] Clinical Study Agreement [Member] Insurance Policy [Member] Termination Of Employee [Member] Breach Of Contract [Member] Punitive Damages [Member] Sale Of Estate [Member] Damages For Unpaid Invoices [Member] Antigen Employees [Member] The equity interest in CBI owned by a Former Business Associate. The equity interest in CBI owned by the Company. Percentage of interest expense directly attributable to an award in settlement of litigation. Derivative Warrant Liability Fair Value Derivative Additional Investment Rights Fair Value Additional Units [Member] Convertible Preferred Stock Conversion Price Value of each share of common stock upon conversion. Increased Preferred Stock Dividend Rate Percentage The number of warrants issued in a noncash (or part noncash) transaction. "Part noncash" refers to that portion of the transaction not resulting in cash receipts or cash payments in the period. Value of remaining fixed rate term debt that was paid. Warrant Expiration Date 31 March 2016 [Member] Warrant Expiration Date 11 July 2016 [Member] Warrant Expiration Date 30 September 2016 [Member] Warrant Expiration Date 1 February 2017 [Member] Warrant Expiration Date 10 August 2017 [Member] Warrant Expiration Date 12 December 2017 [Member] Warrant Expiration Date 17 June 2018 [Member] Board Approved Equity Program [Member] Approved In Good Faith [Member] Series B Convertible Preferred Stock [Member] Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Outstanding Weighted Exercise Price Total number of common shares of an entity that have been sold or granted to shareholders, compared to all common shares. These shares represent capital invested by the firm's shareholders and owners, and may be all or only a portion of the number of shares authorized. Shares issued include shares outstanding. Expressed as a percentage. The cash value associated with exercising stock warrants. Warrants Exercised Warrants Issued Warrants Issued February 2012 [Member] Warrants Issued Price Protection [Member] Warrants Issued August 2012 [Member] Warrants Issued December 2012 [Member] Warrants Issued June 2013 [Member] Warrants Issuable Preferred Stock Conversion Price Per Share Issuing Additional Warrants [Member] Fair Value Warrants [Member] Recognition Of Gain [Member] Derivative Warrants Weighted Average Remaining Life. Adjustments To Additional Paid In Capital Exercise Of Additional Investment Rights Cash received for the sale of real estate that is not part of an investing activity during the current period. The cash inflow from issuance of rights to purchase common shares at predetermined price (usually issued together with corporate debt). Aggregate proceeds received by the entity during the annual period from exercises of stock or unit options and conversion of similar instruments granted under equity-based payment arrangements. Face amount or stated value per share of common stock. Assets, Current Assets Liabilities, Current Liabilities Development Stage Enterprise, Deficit Accumulated During Development Stage Stockholders' Equity Attributable to Parent Liabilities and Equity Gross Profit Operating Expenses Interest Expense Net Income (Loss), Including Portion Attributable to Noncontrolling Interest Net Income (Loss) Available to Common Stockholders, Basic Weighted Average Number of Shares Outstanding, Basic Weighted Average Number of Shares Outstanding, Diluted Gain (Loss) on Disposition of Property Plant Equipment TreasuryStockRedeemedForNonPerformanceOfServices AmortizationOfDeferredDebtIssuanceCostsLoanOriginationFees Increase (Decrease) in Accounts Receivable Increase (Decrease) in Inventories Increase (Decrease) in Other Current Assets Increase (Decrease) in Deferred Revenue Increase (Decrease) in Other Operating Assets and Liabilities, Net Net Cash Provided by (Used in) Operating Activities Payments to Acquire Property, Plant, and Equipment Payments to Acquire Intangible Assets Increase (Decrease) in Restricted Cash Payments to Acquire Short-term Investments AdvancesToAntigenExpress Increase (Decrease) Due from Officers and Stockholders ChangeInNotesReceivableCommonStock Repayments of Related Party Debt Payments for (Proceeds from) Other Investing Activities Net Cash Provided by (Used in) Investing Activities Repayments of Short-term Debt Repayments of Long-term Debt Repayments of Debt and Capital Lease Obligations Payments for Repurchase of Preferred Stock and Preference Stock PaymentOfCostsAssociatedWithConvertibleDebentures Repayments of Convertible Debt Payments for Repurchase of Other Equity Payments for Repurchase of Common Stock Net Cash Provided by (Used in) Financing Activities Cash and Cash Equivalents, Period Increase (Decrease) Schedule of Accounts Payable and Accrued Liabilities [Table Text Block] Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Aggregate Intrinsic Value, Outstanding Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price Accounts Payable and Accrued Liabilities Derivative Liability, Current NumberOfWarrantsDerivativeWarrantLiability CommitmentAndContingencyDomain EX-101.PRE 10 gnbt-20131031_pre.xml XBRL PRESENTATION FILE XML 11 R39.htm IDEA: XBRL DOCUMENT v2.4.0.8
Derivative Liabilities (Details Narrative) (USD $)
3 Months Ended 6 Months Ended 216 Months Ended 6 Months Ended 12 Months Ended 6 Months Ended
Jan. 31, 2014
Jan. 31, 2013
Jan. 31, 2014
Jan. 31, 2013
Jan. 31, 2014
Jan. 31, 2014
Issuing Additional Warrants
Jan. 31, 2013
Issuing Additional Warrants
Jul. 31, 2013
Issuing Additional Warrants
Jan. 31, 2014
Fair Value of Warrants
Jul. 31, 2013
Fair Value of Warrants
Jan. 31, 2014
Recognition of Gain
Derivative warrants weighted average remaining life           3 years 2 months 12 days          
Recognition of gain due to derivative liability $ (2,107,844) $ (4,142,004) $ (230,557) $ (3,783,290) $ (4,086,793) [1] $ 230,557 $ (3,783,290)        
Fair value of derivative liability                 5,259,929 5,234,293  
Additional investment rights           $ 237,566 $ 126,195 $ 1,256,160     $ 892,399
[1] Includes $5,981,403 as adjustment related to the adoption of FASB ASC Topic 815 in "Cumulative from November 2, 1995 (Date of Inception) to January 31, 2014" column. See Note 10 - Derivative Warrant Liability.
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Stockholders’ Deficiency - Accounting allocation of initial proceeds (Details) (USD $)
1 Months Ended 6 Months Ended 216 Months Ended
Jun. 30, 2013
Jan. 31, 2014
Jan. 31, 2013
Jan. 31, 2014
Equity [Abstract]        
Net proceeds $ 1,165,000 $ 750,000 $ 1,450,000 $ 19,670,000
Derivative warrant liability fair value (1,189,744) (942,279)    
Derivative additional investment rights fair value (1,264,683)      
Make whole payments liability (330,750) (216,000)    
Deemed dividend $ (1,620,177) $ 408,279    

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Stock-Based Compensation - Summary of common stock, and non-vested common stock, options granted, forfeited or expired and exercised (Details) (USD $)
6 Months Ended
Jan. 31, 2014
Jan. 31, 2014
Options
   
Options Outstanding   $ 29,701,197
Options Granted 8,879,499  
Options Forfeited or expired 40,000  
Options Exercised 526,306  
Options Outstanding 38,014,390  
Options Exercisable 38,014,390  
Weighted Average Exercise Price per Share
   
Options Forfeited or expired 0.827  
Options Exercised 0.001  
Weighted Average Exercise Price per Share   $ 0.080
Weighted Average Exercise Price per Share, Granted $ 0.001  
Weighted Average Exercise Price per Share, Forfeited or expired     
Weighted Average Exercise Price per Share, Exercised     
Weighted Average Exercise Price per Share, Outstanding $ 0.062  
Weighted Average Exercise Price per Share, Exercisable $ 0.062  
Aggregate Intrinsic Value
   
Options Exercised 21,052  
Options Outstanding 1,357,895  
Options Exercisable 1,357,895  
Non-vested Options
   
Options Outstanding   $ 60,000
Options Granted 8,879,499  
Options Vested (8,939,499)  
Options Forfeited or expired 0  
Options Outstanding 0  
Non-vested Weighted Average Grant Date Fair Value
   
Weighted Average Exercise Price per Share   $ 0.031
Weighted Average Vested, Grant Date Fair Value $ 0.460  
Weighted Average Exercise Price per Share, Forfeited or expired     
Weighted Average Exercise Price per Share, Outstanding $ 0.029  

XML 17 R37.htm IDEA: XBRL DOCUMENT v2.4.0.8
Derivative Liabilities - Fair value assumptions, derivative warrant liability (Details) (USD $)
6 Months Ended 12 Months Ended
Jan. 31, 2014
Jul. 31, 2013
Notes to Financial Statements    
Current exercise price $ 0.03 $ 0.03
Time to expiration 3 years 2 months 12 days 3 years 6 months
Risk-free interest rate 0.69% 0.49%
Estimated volatility 86.00% 85.00%
Dividend   0.00%
Stock price at period end date $ 0.042 $ 0.035
XML 18 R9.htm IDEA: XBRL DOCUMENT v2.4.0.8
Stock-Based Compensation
3 Months Ended
Jan. 31, 2014
Equity [Abstract]  
Stock-Based Compensation

Note 3 – Stock-Based Compensation:

 

As of January 31, 2014, the Company had two stockholder-approved stock incentive plans under which shares and options exercisable for shares of common stock have been or may be granted to employees, directors, consultants and advisors. A total of 12,000,000 shares of common stock are reserved for issuance under the 2001 Stock Option Plan (the 2001 Plan) and 60,000,000 shares of common stock are reserved for issuance under the 2006 Stock Plan as amended (the 2006 Plan). At January 31, 2014, there were 1,353,916 and 6,417,242 shares of common stock reserved for future awards under the 2001 Plan and 2006 Plan, respectively. The Company issues new shares of common stock from the shares reserved under the respective Plans upon conversion or exercise of options and issuance of restricted shares.

 

The 2001 and 2006 Plans (the Plans) are administered by the Board of Directors (the Board). The Board is authorized to select from among eligible employees, directors, advisors and consultants those individuals to whom options are to be granted and to determine the number of shares to be subject to, and the terms and conditions of the options. The Board is also authorized to prescribe, amend and rescind terms relating to options granted under the Plans. Generally, the interpretation and construction of any provision of the Plans or any options granted hereunder is within the discretion of the Board.

 

The Plans provide that options may or may not be Incentive Stock Options (ISOs) within the meaning of Section 422 of the Internal Revenue Code. Only employees of the Company are eligible to receive ISOs, while employees and non-employee directors, advisors and consultants are eligible to receive options which are not ISOs, i.e. “Non-Qualified Options.” The options granted by the Board in connection with its adoption of the Plans were Non-Qualified Options. In addition, the 2006 Plan also provides for restricted stock grants.

The fair value of each option granted is estimated on the grant date using the Black-Scholes option pricing model or the value of the services provided, whichever is more readily determinable. The Black-Scholes option pricing model takes into account, as of the grant date, the exercise price and expected life of the option, the current price of the underlying stock and its expected volatility, expected dividends on the stock and the risk-free interest rate for the term of the option.

 

In the case of restricted stock grants under the 2006 Plan, fair market value of the shares is established as the market price on the date of the stock grant or the value of the services provided, whichever is more readily determinable.

 

The following is a summary of the common stock options granted, forfeited or expired and exercised under the Plans for the six months ended January 31, 2014:

 

       Weighted     
       Average     
       Exercise   Aggregate 
       Price   Intrinsic 
   Options   per Share   Value 
             
Outstanding, August 1, 2013   29,701,197   $0.080      
Add: Granted   8,879,499    0.001      
Less: Forfeited or expired   40,000    0.827      
Less: Exercised   526,306    0.001   21,052 
Outstanding, January 31, 2014   38,014,390   $$  0.062   $1,357,895 
Exercisable, January 31, 2014   38,014,390   $$ 0.062   $1,357,895 

 

The 38,014,390 outstanding options at January 31, 2014 had a weighted average remaining contractual term of 3.94 years.

 

The following is a summary of the non-vested common stock options granted, vested and forfeited under the plans for the six months ended January 31, 2014:

 

       Weighted Average 
       Grant Date 
   Options   Fair Value 
         
Outstanding, August 1, 2013   60,000   $0.460 
Granted   8,879,499    0.029 
Vested   (8,939,499)   0.031 
Forfeited   0   n/a 
Outstanding, January 31, 2014   0   $n/a 

 

As of January 31, 2014, the Company did not have any unrecognized compensation cost related to non-vested share-based compensation arrangements granted under the Plans.

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Pending Litigation (Details Narrative) (USD $)
12 Months Ended 12 Months Ended
Jul. 20, 2001
Jul. 31, 2011
Termination Of Employee
May 20, 2011
Termination Of Employee
Jul. 31, 2011
Breach of contract and detinue
Jul. 31, 2011
Punitive Damages
Jul. 31, 2012
Sale Of Estate
Nov. 16, 2012
Damages for Unpaid Invoices
Jul. 31, 2012
Damages for Unpaid Invoices
Shares of CBI owned by former business associate 50.00%              
Shares of CBI owned by Company 50.00%              
Value of damages sought   $ 7,000,000   $ 550,000 $ 50,000 $ 1,730,000   $ 429,000
Counterclaim proceeding     2,300,000 200,000        
Lawsuit filing date   20-May-11   1-Jun-11   31-Aug-11   31-Dec-11
Name of Plaintiff   Ms. Perri   Golden Bull Estates   Antonio Perri   Vendor
Settlement of litigation             125,000  
Interest per annum, failure to pay settlement               3.00%
Fixed cost per annum, failure to pay settlement               $ 25,000
XML 21 R28.htm IDEA: XBRL DOCUMENT v2.4.0.8
Accounts Payable and Accrued Expenses - Accounts payable and accrued expenses (Details) (USD $)
Jan. 31, 2014
Jul. 31, 2013
Payables and Accruals [Abstract]    
Accounts Payable & Accruals -General and Administrative $ 3,282,163 $ 3,447,618
Accounts Payable & Accruals - Research and Development 3,889,180 3,557,184
Accounts Payable & Accruals - Selling and Marketing 326,929 328,629
Accrued Make Whole Payments on Convertible Preferred Stock (see Note 9) 222,750 251,100
Executive Compensation and Directors' Fees Payable 170,657 76,703
Total $ 7,891,679 $ 7,661,234
XML 22 R30.htm IDEA: XBRL DOCUMENT v2.4.0.8
Net Loss Per Share (“EPS”) (Details Narrative)
3 Months Ended 6 Months Ended
Jan. 31, 2014
Jan. 31, 2013
Jan. 31, 2014
Jan. 31, 2013
Accounting Policies [Abstract]        
Anti-dilutive incremental shares, excluded from Diluted EPS 259,678,976 270,883,228 259,678,976 270,883,228
XML 23 R31.htm IDEA: XBRL DOCUMENT v2.4.0.8
Stockholders’ Deficiency - Stockholders’ deficiency transactions (Details) (USD $)
6 Months Ended 216 Months Ended
Jan. 31, 2014
Jan. 31, 2013
Jan. 31, 2014
Issuance of common stock for services, Amount $ 207,000 $ 185,342 $ 15,106,700
Common Stock
     
Issuance of common stock on conversion of convertible preferred stock, Shares 30,166,666    
Issuance of common stock on conversion of convertible preferred stock, Amount 30,167    
Issuance of common stock as make-whole payments on convertible preferred stock, Shares 8,730,195    
Issuance of common stock as make-whole payments on convertible preferred stock, Amount 8,730    
Issuance of common stock for services, Shares 1,233,334    
Issuance of common stock for services, Amount 1,233    
Issuance of common stock as employee compensation, Shares 4,333,333    
Issuance of common stock as employee compensation, Amount 4,333    
Issuance of common stock for cash warrant exercises, Shares 70,732,022    
Issuance of common stock for cash warrant exercises, Amount 70,731    
Issuance of options in lieu of deferred salary       
Exercise of employee stock options, Shares 526,306    
Exercise of employee stock options, Amount 526    
Exercise of employee stock options       
Amortization of stock options as employee compensation       
Total, Shares 115,721,856    
Total, Amount 115,720    
Additional Paid-In Capital
     
Issuance of common stock on conversion of convertible preferred stock, Amount (30,167)    
Issuance of common stock as make-whole payments on convertible preferred stock, Amount 235,620    
Issuance of common stock for services, Amount 75,767    
Issuance of common stock as employee compensation, Amount 125,667    
Issuance of common stock for cash warrant exercises, Amount 4,090,828    
Issuance of options in lieu of deferred salary 257,505    
Exercise of employee stock options 237,566    
Amortization of stock options as employee compensation 5,365    
Total, Amount 4,998,151    
Change to Stockholders Equity
     
Issuance of common stock on conversion of convertible preferred stock, Amount       
Issuance of common stock as make-whole payments on convertible preferred stock, Amount 244,350    
Issuance of common stock for services, Amount 77,000    
Issuance of common stock as employee compensation, Amount 130,000    
Issuance of common stock for cash warrant exercises, Amount 4,161,559    
Issuance of options in lieu of deferred salary 257,505    
Exercise of employee stock options 237,566    
Amortization of stock options as employee compensation 5,365    
Total, Amount $ 5,113,871    
XML 24 R8.htm IDEA: XBRL DOCUMENT v2.4.0.8
Effects of Recent Accounting Pronouncements
3 Months Ended
Jan. 31, 2014
Accounting Changes and Error Corrections [Abstract]  
Effects of Recent Accounting Pronouncements

Note 2 – Effects of Recent Accounting Pronouncements:

 

Recently Adopted Accounting Pronouncements

In June 2011, the FASB issued guidance regarding the presentation of Comprehensive Income within financial statements. The guidance was effective for the Company’s annual fiscal period ended July 31, 2013. The adoption of this new accounting guidance did not have a material impact on the Company’s consolidated financial statements.

XML 25 R32.htm IDEA: XBRL DOCUMENT v2.4.0.8
Stockholders’ Deficiency - Summary of warrants issued, forfeited or expired and exercised (Details) (USD $)
6 Months Ended
Jan. 31, 2014
Equity [Abstract]  
Outstanding, August 1, 2013 238,229,939
Plus: Issued $ 26,666,668
Less: Exercised 70,732,022
Outstanding, October 31, 2013 194,164,585
XML 26 R40.htm IDEA: XBRL DOCUMENT v2.4.0.8
Income from Assets Held for Investment, net (Details Narrative) (USD $)
1 Months Ended 12 Months Ended
Aug. 31, 2013
Sep. 30, 2012
Nov. 30, 2013
Jan. 31, 2014
Jan. 31, 2013
Notes to Financial Statements          
Gross proceeds from sale of real estate $ 883,780 $ 1,579,189      
Property, net book value 694,911 585,064      
Gain on sale of real estate 188,869 994,125      
Partial discharge of mortgage 606,806        
Legal fees, interest, penalties from sale of real estate, approximation 73,628        
Net proceeds from sale of real estate 203,346 1,028,780      
Principal of mortgage discharged completely upon sale   480,951 606,806    
Income from properties held for investment       $ 4,738 $ 89,741
Properties held for investment, interest rate     9.75%    
XML 27 R2.htm IDEA: XBRL DOCUMENT v2.4.0.8
INTERIM CONSOLIDATED BALANCE SHEETS (UNAUDITED) (USD $)
Jan. 31, 2014
Jul. 31, 2013
Jan. 31, 2014
Series A Convertible Preferred Stock
Jul. 31, 2013
Series A Convertible Preferred Stock
Jan. 31, 2014
Series B Convertible Preferred Stock
Jul. 31, 2013
Series B Convertible Preferred Stock
Jan. 31, 2014
Series C Convertible Preferred Stock
Jul. 31, 2013
Series C Convertible Preferred Stock
Jan. 31, 2014
Series D Convertible Preferred Stock
Jul. 31, 2013
Series D Convertible Preferred Stock
Jan. 31, 2014
Series E Convertible Preferred Stock
Jul. 31, 2013
Series E Convertible Preferred Stock
ASSETS                        
Cash and cash equivalents $ 3,141,212 $ 1,708,954                    
Other current assets 102,428 98,315                    
Total Current Assets 3,243,640 1,807,269                    
Property and Equipment, Net 16,440 85,406                    
Assets Held for Investment, Net (Note 11)    640,772                    
Patents, Net 2,163,696 2,319,416                    
TOTAL ASSETS 5,423,776 4,852,863                    
LIABILITIES AND STOCKHOLDERS' (DEFICIENCY)/EQUITY                        
Accounts payable and accrued expenses (Note 5) 7,891,679 7,661,234                    
Deferred revenue 223,662 224,843                    
Current maturities of long-term debt (Note 11)    617,665                    
Total Current Liabilities 8,115,341 8,503,742                    
Derivative Warrant Liability (Note 10) 5,259,929 5,234,293                    
Derivative Additional Investment Rights Liability (Note 10) 126,195 1,256,160                    
Total Liabilities 13,501,465 14,994,195                    
Stockholders' Deficiency (Note 9):                        
9% Convertible Preferred Stock                                    
Common stock, $.001 par value; authorized 1,500,000,000 shares at January 31, 2014 and July 31, 2013; 696,050,476 and 580,329,160 issued and outstanding at January 31, 2014 and July 31, 2013, respectively 696,050 580,329                    
Additional paid-in capital 361,399,963 356,401,812                    
Deficit accumulated during the development stage (370,953,051) (367,888,576)                    
Accumulated other comprehensive income 779,349 765,103                    
Total Stockholders' Deficiency (8,077,689) (10,141,332)                    
TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIENCY $ 5,423,776 $ 4,852,863                    
XML 28 R6.htm IDEA: XBRL DOCUMENT v2.4.0.8
Basis of Presentation
3 Months Ended
Jan. 31, 2014
Accounting Policies [Abstract]  
Basis of Presentation

Note 1 – Basis of Presentation:

 

The accompanying unaudited interim consolidated financial statements (“interim statements”) have been prepared pursuant to the rules and regulations for reporting on Form 10-Q. Accordingly, certain information and disclosures required by generally accepted accounting principles for complete financial statements are not included herein. The interim statements should be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s latest Annual Report on Form 10-K. The results for the six months ended January 31, 2014 may not be indicative of the results for the entire year.

 

Interim statements are subject to possible adjustments in connection with the annual audit of the Company’s accounts for fiscal year 2014. In the Company’s opinion, all adjustments necessary for a fair presentation of these interim statements have been included and are of a normal and recurring nature.

 

The Company is a development stage company, which has a limited history of operations and limited revenue to date. This revenue has been comprised mainly of the sale of our confectionary products, although the Company has recognized $600,000 relating to upfront license fees for the signing of license and distribution agreements for Generex Oral-lyn™. Additionally, the Company has several product candidates that are in various research or early stages of pre-clinical and clinical development. There can be no assurance that the Company will be successful in obtaining regulatory clearance for the sale of existing or any future products or that any of the Company’s products will be commercially viable.

 

Going Concern

The accompanying interim statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The Company has experienced negative cash flows from operations since inception and has an accumulated deficit of approximately $371 million and a working capital deficiency of approximately $4.9 million at January 31, 2014. The Company has funded its activities to date almost exclusively from debt and equity financings, as well as the recent sales of non-essential real estate assets in fiscal 2012, fiscal 2013 and the first half of fiscal 2014 (see Note 11).

 

The Company will continue to require substantial funds to continue research and development, including pre-clinical studies and clinical trials of its product candidates, and to commence sales and marketing efforts, if the U.S. Food and Drug Administration or other regulatory approvals are obtained.  Management’s plans in order to meet its operating cash flow requirements include financing activities such as private placements of its common stock, preferred stock offerings, issuances of debt and convertible debt instruments.  Management will be limited in the financing activities that the Company undertakes in the near future as the securities purchase agreements that the Company entered into on June 17, 2013 and January 14, 2014 with certain investors prohibit the Company from (i) issuing additional equity securities until 60 days after the effective date of a registration statement covering the resale of the common stock issuable upon exercise of the warrants and conversion of the preferred stock sold in those transactions; and (ii) issuing additional debt or equity securities with variable conversion or exercise prices until June 17, 2014 and January 14, 2015, respectively. Management is also actively pursuing financial and strategic alternatives, including strategic investments and divestitures, industry collaboration activities and strategic partners.  Management has sold its non-essential real estate assets which were classified as Assets Held for Investment to augment its cash position.

 

These factors raise substantial doubt regarding the Company’s ability to continue as a going concern. There are no assurances that such additional funding will be achieved and that it will succeed in its future operations. The interim statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or amounts of liabilities that might be necessary should the Company be unable to continue in existence. The Company’s inability to obtain required funding in the near future or its inability to obtain funding on favorable terms will have a material adverse effect on its operations and strategic development plan for future growth. If the Company cannot successfully raise additional capital and implement its strategic development plan, its liquidity, financial condition and business prospects will be materially and adversely affected, and the Company may have to cease operations.

XML 29 R35.htm IDEA: XBRL DOCUMENT v2.4.0.8
Stockholders’ Deficiency (Details Narrative) (USD $)
1 Months Ended 6 Months Ended 216 Months Ended 1 Months Ended 6 Months Ended 4 Months Ended 6 Months Ended 11 Months Ended 4 Months Ended 6 Months Ended 11 Months Ended 6 Months Ended 6 Months Ended 12 Months Ended 35 Months Ended
Jun. 30, 2013
Jan. 31, 2014
Jan. 31, 2013
Jan. 31, 2014
Jul. 31, 2013
Jun. 30, 2013
Series E Convertible Preferred Stock
Jan. 31, 2014
Series E Convertible Preferred Stock
Jan. 15, 2014
Series E Convertible Preferred Stock
Jul. 31, 2013
Series E Convertible Preferred Stock
Jun. 17, 2014
Convertible Preferred Stock [Member]
Jan. 14, 2014
Series E Convertible Preferred Stock
Jan. 31, 2014
Series A Convertible Preferred Stock
Dec. 10, 2012
Series B Convertible Preferred Stock
Jan. 31, 2014
Series B Convertible Preferred Stock
Jan. 31, 2014
Series B Convertible Preferred Stock
Dec. 10, 2012
Series C Convertible Preferred Stock
Jan. 31, 2014
Series C Convertible Preferred Stock
Jan. 31, 2014
Series C Convertible Preferred Stock
Jan. 31, 2014
Series D Convertible Preferred Stock
Mar. 28, 2013
Series D Convertible Preferred Stock
Jan. 31, 2014
Series E Convertible Preferred Stock
Jun. 17, 2017
Series E Convertible Preferred Stock
Jun. 17, 2016
Series E Convertible Preferred Stock
Jun. 17, 2013
Series E Convertible Preferred Stock
Jan. 31, 2014
Additional Units
Convertible preferred stock, shares authorized             2,450   2,450     5,500 792 2,000 2,000 650 750 750 750   1,200     2,450  
Convertible preferred stock, cumulative percentage of interest             9.00%   9.00%     10.00%   9.00% 9.00%   9.00% 9.00% 9.00%         9.00%  
Convertible preferred stock, par value (in dollars per share)             $ 1,000   $ 1,000     $ 1,000   $ 1,000 $ 1,000   $ 1,000 $ 1,000 $ 1,000         $ 1,000 $ 1,000
Convertible preferred stock, shares issued             825   930     2,575   2,000 2,000   750 750 750         1,225  
Common shares attributable to conversion of preferred stock                       17,166,666 9,897,500 13,333,333 26,393,333 8,125,000 9,375,000 21,666,666 24,999,999   40,833,335        
Common stock issued upon conversion of preferred stock                       17,166,666   38,520,832 38,520,832   22,916,665 22,916,665 24,999,999   40,000,000        
Common stock issued as "make-whole payments" on conversions of preferred stock                       6,129,666   14,819,679 14,819,679   6,664,863 6,664,863 7,825,191   11,385,194        
Convertible preferred stock conversion price                         $ 0.08   $ 0.03 $ 0.03 $ 0.08                
Net proceeds from financing $ 1,165,000 $ 750,000 $ 1,450,000 $ 19,670,000                   $ 1,975,000       $ 725,000 $ 725,000   $ 1,165,000        
Preferred stock, face value                                       750,000          
Common stock, effective conversion price                                             $ 0.03    
Preferred stock, dividend rate percentage                                           3.00% 9.00%    
Increased preferred stock dividend rate percentage                                           0.18      
Conversion of preferred stock                                         295   270    
Conversion of stock, amount converted                                             1,000    
Warrants issued to investors           40,833,335                             26,666,668        
Aggregate subscription amount, maximum                                                 1,225,000
"Make-whole payments", value                                         216,000        
Accounts payable and accrued expenses                                         99,900        
Convertible preferred shares sold               800     800                            
Shares of common stock   $ 696,050   $ 696,050 $ 580,329     $ 26,666,668   $ 425 $ 26,666,668                            
XML 30 R22.htm IDEA: XBRL DOCUMENT v2.4.0.8
Derivative Liabilities (Tables)
3 Months Ended
Jan. 31, 2014
Notes to Financial Statements  
Derivative warrant liability
              Value No. of Warrants
Balance at August 1, 2012 – Derivative warrant liability $   4,081,627 55,148,530
Additional warrants issued in August 2012 financing   624,797   9,375,000
Additional warrants issued in December 2012 financing   762,355 24,999,999
Additional warrants issued in June 2013 financing   1,189,744  40,833,335
Additional warrants from price protection features of existing warrants   7,484,550   236,219,094
Exercise of warrants (5,629,130) (145,888,421)
Decrease in fair value of derivative warrant liability (3,279,650)                   n/a
Balance at July 31, 2013 – Derivative warrant liability  $   5,234,293   220,687,537
Exercise of warrants (2,039,599) (70,732,022)
Additional warrants issued in January 2014 financing   942,279 26,666,668
Increase in fair value of derivative warrant liability    1,122,959                  n/a
Balance at January 31, 2014 – Derivative warrant liability  $  5,259,929   176,622,183
Fair value assumptions, derivative warrant liability
   January 31, 2014   July 31, 2013 
Current exercise price  $0.03   $0.03 
Time to expiration   3.2 years    3.5 years 
Risk-free interest rate   0.69%   0.49%
Estimated volatility   86%   85%
Dividend   -0-    -0- 
Stock price at period end date  $0.03   $0.035 
Fair value assumptions, derivative additional investment rights liability
   January 31, 2014   July 31, 2013 
Underlying number of units of convertible preferred stock   425    1,225 
Underlying number of units of warrants   14,166,667    40,833,335 
Current exercise price of warrants  $0.03   $0.03 
Current conversion price of preferred stock  $0.03   $0.03 
Time to expiration   0.38 years    0.88 years 
Risk-free interest rate   0.06%   0.11%
Estimated volatility   67%   114%
Dividend   -0-    -0- 
Stock price at period end date  $0.042   $0.035 
XML 31 R36.htm IDEA: XBRL DOCUMENT v2.4.0.8
Derivative Liabilities - Derivative warrant liability (Details) (USD $)
6 Months Ended 12 Months Ended
Jan. 31, 2014
Jul. 31, 2013
Balance - Derivative warrant liability Value $ 5,234,293 $ 4,081,627
No. of Warrants - Derivative warrant liability 220,687,537 55,148,530
Exercise of Warrants 2,039,599 (5,629,130)
Warrants Exercised 70,732,022 (145,888,421)
Increase in fair value of derivative warrant liability 1,122,959 (3,279,650)
Balance - Derivative warrant liability Value 5,259,929 5,234,293
No. of Warrants - Derivative warrant liability 176,622,183 220,687,537
August 2012
   
Additional warrants issued   624,797
Warrants Issued   9,375,000
December 2012
   
Additional warrants issued   762,355
Warrants Issued   24,999,999
June 2013
   
Additional warrants issued   1,189,744
Warrants Issued   40,833,335
Price Protection
   
Additional warrants issued   7,484,550
Warrants Issued   236,219,094
January 2014
   
Additional warrants issued $ 942,279  
Warrants Issued 26,666,668  
XML 32 R24.htm IDEA: XBRL DOCUMENT v2.4.0.8
Going Concern (Details Narrative) (USD $)
216 Months Ended
Jan. 31, 2014
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Accumulated deficit since inception $ 371,000,000
Working capital deficiency $ 4,900,000
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Going Concern
3 Months Ended
Jan. 31, 2014
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Going Concern

Going Concern

The accompanying interim statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The Company has experienced negative cash flows from operations since inception and has an accumulated deficit of approximately $371 million and a working capital deficiency of approximately $4.9 million at January 31, 2014. The Company has funded its activities to date almost exclusively from debt and equity financings, as well as the recent sales of non-essential real estate assets in fiscal 2012, fiscal 2013 and the first half of fiscal 2014 (see Note 11).

 

The Company will continue to require substantial funds to continue research and development, including pre-clinical studies and clinical trials of its product candidates, and to commence sales and marketing efforts, if the U.S. Food and Drug Administration or other regulatory approvals are obtained.  Management’s plans in order to meet its operating cash flow requirements include financing activities such as private placements of its common stock, preferred stock offerings, issuances of debt and convertible debt instruments.  Management will be limited in the financing activities that the Company undertakes in the near future as the securities purchase agreements that the Company entered into on June 17, 2013 and January 14, 2014 with certain investors prohibit the Company from (i) issuing additional equity securities until 60 days after the effective date of a registration statement covering the resale of the common stock issuable upon exercise of the warrants and conversion of the preferred stock sold in those transactions; and (ii) issuing additional debt or equity securities with variable conversion or exercise prices until June 17, 2014 and January 14, 2015, respectively. Management is also actively pursuing financial and strategic alternatives, including strategic investments and divestitures, industry collaboration activities and strategic partners.  Management has sold its non-essential real estate assets which were classified as Assets Held for Investment to augment its cash position.

 

These factors raise substantial doubt regarding the Company’s ability to continue as a going concern. There are no assurances that such additional funding will be achieved and that it will succeed in its future operations. The interim statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or amounts of liabilities that might be necessary should the Company be unable to continue in existence. The Company’s inability to obtain required funding in the near future or its inability to obtain funding on favorable terms will have a material adverse effect on its operations and strategic development plan for future growth. If the Company cannot successfully raise additional capital and implement its strategic development plan, its liquidity, financial condition and business prospects will be materially and adversely affected, and the Company may have to cease operations.

XML 35 R3.htm IDEA: XBRL DOCUMENT v2.4.0.8
INTERIM CONSOLIDATED BALANCE SHEETS (UNAUDITED) (Parenthetical) (USD $)
Jan. 31, 2014
Jul. 31, 2013
Common stock, par value (in dollars per share) $ 0.001 $ 0.001
Common stock, shares authorized 1,500,000,000 1,500,000,000
Common stock, shares outstanding 696,050,476 580,329,160
Series A Convertible Preferred Stock
   
Convertible preferred stock, par value (in dollars per share) $ 1,000 $ 1,000
Convertible preferred stock, shares authorized 5,500 5,500
Convertible preferred stock, shares issued 0 0
Convertible preferred stock, cumulative percentage of interest 9.00% 9.00%
Series B Convertible Preferred Stock
   
Convertible preferred stock, par value (in dollars per share) $ 1,000 $ 1,000
Convertible preferred stock, shares authorized 2,000 2,000
Convertible preferred stock, shares issued 0 0
Convertible preferred stock, shares outstanding 0 0
Convertible preferred stock, cumulative percentage of interest 9.00% 9.00%
Series C Convertible Preferred Stock
   
Convertible preferred stock, par value (in dollars per share) $ 1,000 $ 1,000
Convertible preferred stock, shares authorized 750 750
Convertible preferred stock, shares issued 0 0
Convertible preferred stock, shares outstanding 0 0
Convertible preferred stock, cumulative percentage of interest 9.00% 9.00%
Series D Convertible Preferred Stock
   
Convertible preferred stock, par value (in dollars per share) $ 1,000 $ 1,000
Convertible preferred stock, shares authorized 750 750
Convertible preferred stock, shares issued 0 0
Convertible preferred stock, shares outstanding 0 0
Convertible preferred stock, cumulative percentage of interest 9.00% 9.00%
Series E Convertible Preferred Stock
   
Convertible preferred stock, par value (in dollars per share) $ 1,000 $ 1,000
Convertible preferred stock, shares authorized 2,450 2,450
Convertible preferred stock, shares issued 825 930
Convertible preferred stock, shares outstanding 825 930
Convertible preferred stock, cumulative percentage of interest 9.00% 9.00%
XML 36 R17.htm IDEA: XBRL DOCUMENT v2.4.0.8
Income from Assets Held for Investment, net
3 Months Ended
Jan. 31, 2014
Notes to Financial Statements  
Income from Assets Held for Investment, net

Note 11 – Income from Assets Held for Investment, net:

 

In August 2013, the Company sold a property which was held for investment for gross proceeds after real estate commissions of $883,780. This property had a net book value of $694,911, resulting in an accounting gain of $188,869 which is included in income from assets held for investment, net on the interim consolidated statement of operations. The property was secured by a mortgage which was discharged upon the sale, as described in the last paragraph of this note below. After the discharge of the mortgage ($606,806), as well as legal fees, interest, penalties and other costs ($73,628 in aggregate) the sale resulted in net cash proceeds to the Company of $203,346.

 

In September 2012, the Company sold its head office real estate in Toronto for gross proceeds after real estate commissions of $1,579,189. This property had a net book value of $585,064, resulting in an accounting gain of $994,125 which is included in income from assets held for investment, net on the interim consolidated statement of operations. The net proceeds after commissions and other expenses were used to discharge or partially discharge the first and second mortgages on the property. The first mortgage on the property, with remaining principal of $480,951, was discharged completely upon sale. The remaining net proceeds of $1,028,780 after expenses and the discharge of the first mortgages was used to partially discharge the second mortgage and the Company did not receive any of the net proceeds from this property sale.

 

The remaining income of $4,738 in this category in the six months ended January 31, 2014, pertains to rental income from properties held for investment, net of carrying and operating expenses, compared to $89,741 in the prior year period.

 

Prior to the August 2013 property sale, the properties held for investment had an interest only first mortgage which closed on November 30, 2012 with a principal amount $606,806, an interest rate of 9.75% compounded semi-annually and a maturity date of November 30, 2013. Upon the sale of the property, the mortgage was discharged.

XML 37 R1.htm IDEA: XBRL DOCUMENT v2.4.0.8
Document and Entity Information
6 Months Ended
Jan. 31, 2014
Mar. 03, 2014
Document And Entity Information    
Entity Registrant Name GENEREX BIOTECHNOLOGY CORP  
Entity Central Index Key 0001059784  
Document Type 10-Q  
Document Period End Date Jan. 31, 2014  
Amendment Flag false  
Current Fiscal Year End Date --07-31  
Is Entity a Well-known Seasoned Issuer? No  
Is Entity a Voluntary Filer? No  
Is Entity's Reporting Status Current? Yes  
Entity Filer Category Smaller Reporting Company  
Entity Common Stock, Shares Outstanding   730,480,474
Document Fiscal Period Focus Q2  
Document Fiscal Year Focus 2014  
XML 38 R18.htm IDEA: XBRL DOCUMENT v2.4.0.8
Subsequent Events
3 Months Ended
Jan. 31, 2014
Subsequent Events [Abstract]  
Subsequent Events

Note 12 – Subsequent Events:

 

The Company has evaluated subsequent events occurring after the balance sheet date through the date the interim consolidated financial statements were issued and determined that there are no events requiring financial statement disclosure.

XML 39 R4.htm IDEA: XBRL DOCUMENT v2.4.0.8
INTERIM CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) (USD $)
3 Months Ended 6 Months Ended 216 Months Ended
Jan. 31, 2014
Jan. 31, 2013
Jan. 31, 2014
Jan. 31, 2013
Jan. 31, 2014
Income Statement [Abstract]          
Revenues, net             $ 5,110,784
Cost of Goods Sold             1,620,375
Gross profit             3,490,409
Operating Expenses:          
Research and development 213,599 500,482 749,773 1,153,877 134,918,461
Research and development - related party             220,218
Selling and marketing             9,333,214
General and administrative 797,262 790,298 1,704,139 2,076,934 153,442,930
General and administrative - related party             314,328
Total Operating Expenses 1,010,861 1,290,780 2,453,912 3,230,811 298,229,151
Operating Loss (1,010,861) (1,290,780) (2,453,912) (3,230,811) (294,738,742)
Other Income (Expense):          
Miscellaneous income             686,303
Income from assets held for investment, net (Note 11)    40,998 193,607 1,083,866 5,773,029
Interest income 23 82 46 307 7,782,292
Interest expense (67,608) (249,281) (165,380) (367,256) (69,704,284)
Change in fair value of derivative liabilities (Note 10) (2,107,844) (4,142,004) (230,557) (3,783,290) (4,086,793) [1]
Loss on extinguishment of debt             (14,134,068)
Net Income/(Loss) Before Undernoted (3,186,290) (5,640,985) (2,656,196) (6,297,184) (368,422,263)
Minority Interest Share of Loss             3,038,185
Net Income/(Loss) (Note 4) (3,186,290) (5,640,985) (2,656,196) (6,297,184) (365,384,078)
Preferred Stock Dividend 408,279    408,279 102,297 5,568,973
Net Income/(Loss) Available to Common Stockholders $ (3,594,569) $ (5,640,985) $ (3,064,475) $ (6,399,481) $ (370,953,051)
Net Income/(Loss) Per Common Share (Note 8) (in dollars per share)          
Basic $ (0.01) $ (0.01) $ (0.01) $ (0.02)  
Diluted $ (0.01) $ (0.01) $ (0.01) $ (0.02)  
Shares Used to Compute Earnings/(Loss) per Share (Note 8)          
Basic 627,522,138 386,422,031 611,449,549 375,366,195  
Diluted 627,522,138 386,422,031 611,449,549 375,366,195  
[1] Includes $5,981,403 as adjustment related to the adoption of FASB ASC Topic 815 in "Cumulative from November 2, 1995 (Date of Inception) to January 31, 2014" column. See Note 10 - Derivative Warrant Liability.
XML 40 R12.htm IDEA: XBRL DOCUMENT v2.4.0.8
Pending Litigation
3 Months Ended
Jan. 31, 2014
Commitments and Contingencies Disclosure [Abstract]  
Pending Litigation

Note 6 – Pending Litigation:

 

In February 2001, a former business associate of the former Vice President of Research and Development (“VP”) of the Company and an entity known as Centrum Technologies Inc. (“CTI”) commenced an action in the Ontario Superior Court of Justice against the Company and the VP seeking, among other things, damages for alleged breaches of contract and tortious acts related to a business relationship between this former associate and the VP that ceased in July 1996. The plaintiffs’ statement of claim also seeks to enjoin the use, if any, by the Company of three patents allegedly owned by CTI. The three patents are entitled Liquid Formulations for Proteinic Pharmaceuticals, Vaccine Delivery System for Immunization, Using Biodegradable Polymer Microspheres, and Controlled Releases of Drugs or Hormones in Biodegradable Polymer Microspheres. It is the Company’s position that the buccal drug delivery technologies which are the subject matter of the Company’s research, development, and commercialization efforts, including Generex Oral-lyn™ and the RapidMist™ Diabetes Management System, do not make use of, are not derivative of, do not infringe upon, and are entirely different from the intellectual property identified in the plaintiffs’ statement of claim. On July 20, 2001, the Company filed a preliminary motion to dismiss the action of CTI as a nonexistent entity or, alternatively, to stay such action on the grounds of want of authority of such entity to commence the action. The plaintiffs brought a cross motion to amend the statement of claim to substitute Centrum Biotechnologies, Inc. (“CBI”) for CTI. CBI is a corporation of which 50 percent of the shares are owned by the former business associate and the remaining 50 percent are owned by the Company. Consequently, the shareholders of CBI are in a deadlock. The court granted the Company’s motion to dismiss the action of CTI and denied the plaintiffs’ cross motion without prejudice to the former business associate to seek leave to bring a derivative action in the name of or on behalf of CBI. The former business associate subsequently filed an application with the Ontario Superior Court of Justice for an order granting him leave to file an action in the name of and on behalf of CBI against the VP and the Company. The Company opposed the application. In September 2003, the Ontario Superior Court of Justice granted the request and issued an order giving the former business associate leave to file an action in the name of and on behalf of CBI against the VP and the Company. A statement of claim was served in July 2004. The Company is not able to predict the ultimate outcome of this legal proceeding at the present time or to estimate an amount or range of potential loss, if any, from this legal proceeding.

 

On May 20, 2011, Ms. Perri filed a statement of claim (subsequently amended) in the Ontario Superior Court of Justice, naming as defendants the Company and certain directors of the Company, Mr. Barratt, Ms. Masterson, Mr. McGee, and Mr. Fletcher. In this action, Ms. Perri has alleged that defendants engaged in discrimination, harassment, bad faith and infliction of mental distress in connection with the termination of her employment with the Company. Ms. Perri is seeking damages in this action in excess of $7,000,000 for, among other things, breach of contract, breach of fiduciary duty, violations of the Ontario Human Rights Code and aggravated and punitive damages. On September 20, 2011, the defendants filed a statement of defense and counterclaim, also naming Time Release Corp., Khazak Group Consulting Corp., and David Khazak, C.A. as defendants by counterclaim, and seeking damages of approximately $2.3 million in funds that the defendants allege Ms. Perri wrongly caused the Company to pay to third parties in varying amounts over several years and an accounting of certain third-party payments, plus interests and costs. The factual basis for the counterclaim involves payments made by the Company to third parties believed to be related to Ms. Perri. The Company intends to defend this action and pursue its counterclaim vigorously and is not able to predict the ultimate outcome of this legal proceeding at the present time or to estimate an amount or range of potential loss, if any, from this legal proceeding.

 

On June 1, 2011, Golden Bull Estates Ltd. filed a claim (subsequently amended) in the Ontario Superior Court of Justice, naming the Company, 1097346 Ontario, Inc. and Generex Pharmaceuticals, Inc. as defendants. The plaintiff, Golden Bull Estates, is controlled by Ms. Perri. The plaintiff alleges damages in the amount of $550,000 for breach of contract, $50,000 for punitive damages, plus interest and costs. The plaintiff’s claims relate to an alleged contract between the plaintiff and the Company for property management services for certain Ontario properties owned by the Company. The Company terminated the plaintiff’s property management services in April 2011. Following the close of pleadings, the Company served a motion for summary judgment. The plaintiff responded by amending its statement of claim to include a claim to the Company’s interest in certain of its real estate holdings. The plaintiff moved for leave to issue and register a Certificate of Pending Litigation in respect of this real estate. The motion was not successful in respect of any current real estate holdings of the Company. The Company is not able to predict the ultimate outcome of this legal proceeding at the present time or to estimate an amount or range of potential loss, if any, from this legal proceeding.

 

In August 2011, the estate of Antonio Perri, the late father of Ms. Perri, commenced an action against Generex Pharmaceuticals, Inc., the law firm of Brans, Lehun, Baldwin LLP and William Lehun in the Ontario Superior Court of Justice claiming that the estate is entitled to the proceeds of sale (approximately $1,730,000) received by the Company on its sale of two properties to Golden Bull Estates Ltd., a company controlled by Ms. Perri. The suit alleges that no consideration was received when the Company purchased the two properties from Antonio Perri in 1998. The Company has responded to this statement of claim and intends to defend this action vigorously. The Company is not able to predict the ultimate outcome of this legal proceeding at the present time or to estimate an amount or range of potential loss, if any, from this legal proceeding.

 

In December 2011, a vendor of the Company commenced an action against the Company and its subsidiary, Generex Pharmaceuticals, Inc., in the Ontario Superior Court of Justice claiming damages for unpaid invoices including interest in the amount of $429,000, in addition to costs and further interest.  The Company responded to this statement of claim and also asserted a counterclaim in the proceeding for $200,000 arising from the vendor’s breach of contract and detinue, together with interest and costs. On November 16, 2012, the parties agreed to settle this action and the Company has agreed to pay the plaintiff $125,000, following the spinout of its subsidiary Antigen, from the proceeds of any public or private financing related to Antigen subsequent to such spinout.  Each party agreed to execute mutual releases to the claim and counterclaim to be held in trust by each party’s counsel until payment of the settlement amount.  Following payment to the plaintiff, the parties agree that a Consent Dismissal Order without costs will be filed with the court.  If the Company fails to make the payment following completion of any post-spinout financing related to Antigen or any other subsidiaries, the Plaintiffs may take out a judgment in the amount of the claim plus interest of 3% per annum and costs fixed at $25,000.

 

The Company is involved in certain other legal proceedings in addition to those specifically described herein. Subject to the uncertainty inherent in all litigation, the Company does not believe at the present time that the resolution of any of these legal proceedings is likely to have a material adverse effect on the Company’s consolidated financial position, operations or cash flows.

 

With respect to all litigation, as additional information concerning the estimates used by the Company becomes known, the Company reassesses its position both with respect to accrued liabilities and other potential exposures.

XML 41 R11.htm IDEA: XBRL DOCUMENT v2.4.0.8
Accounts Payable and Accrued Expenses
3 Months Ended
Jan. 31, 2014
Payables and Accruals [Abstract]  
Accounts Payable and Accrued Expenses

Note 5 – Accounts Payable and Accrued Expenses:

 

Accounts payable and accrued expenses consist of the following:

   January 31, 2014   July 31, 2013 
Accounts Payable and Accruals – General and Administrative  $3,282,163   $3,447,618 
Accounts Payable and Accruals – Research and Development   3,889,180    3,557,184 
Accounts Payable and Accruals – Selling and Marketing   326,929    328,629 
Accrued Make-whole Payments on Convertible Preferred Stock (see Note 9)  222,750    251,100 
Executive Compensation and Directors’ Fees Payable   170,657    76,703 
Total  $7,891,679   $7,661,234 
XML 42 R23.htm IDEA: XBRL DOCUMENT v2.4.0.8
Basis of Presentation (Details Narrative) (USD $)
3 Months Ended
Jan. 31, 2014
Accounting Policies [Abstract]  
Recognized upfront license fees $ 600,000
XML 43 R19.htm IDEA: XBRL DOCUMENT v2.4.0.8
Stock-Based Compensation (Tables)
3 Months Ended
Jan. 31, 2014
Equity [Abstract]  
Summary of common stock options granted, forfeited or expired and exercised
       Weighted     
       Average     
       Exercise   Aggregate 
       Price   Intrinsic 
   Options   per Share   Value 
             
Outstanding, August 1, 2013   29,701,197   $0.080      
Add: Granted   8,879,499    0.001      
Less: Forfeited or expired   40,000    0.827      
Less: Exercised   526,306    0.001   21,052 
Outstanding, January 31, 2014   38,014,390   $$  0.062   $1,357,895 
Exercisable, January 31, 2014   38,014,390   $$ 0.062   $1,357,895 
Summary of non-vested common stock options granted, vested and forfeited
       Weighted Average 
       Grant Date 
   Options   Fair Value 
         
Outstanding, August 1, 2013   60,000   $0.460 
Granted   8,879,499    0.029 
Vested   (8,939,499)   0.031 
Forfeited   0   n/a 
Outstanding, January 31, 2014   0   $n/a 
XML 44 R15.htm IDEA: XBRL DOCUMENT v2.4.0.8
Stockholders’ Deficiency
3 Months Ended
Jan. 31, 2014
Equity [Abstract]  
Stockholders’ Deficiency

Note 9 – Stockholders’ Deficiency:

 

Common Stock

During the six months ended January 31, 2014, the Company issued or committed to issue 1,233,334 shares of common stock to various consultants for services rendered in the amount of $77,000. The shares were valued at a range of prices from $0.03 per share to $0.15 per share based on the quoted market price of the Company’s common stock on the dates of the issuances or commitment to issue.

 

During the six months ended January 31, 2014, the Company issued or committed to issue 4,333,333 shares of common stock valued at $130,000 as employee compensation. The shares were valued at $0.03 per share based on the quoted market price of the Company’s common stock on the dates of the issuances or commitment to issue.

 

During the six months ended January 31, 2014, the Company issued 30,166,666 shares of common stock in conjunction with the conversion of 905 shares of the Series E 9% Convertible Preferred Stock and 8,730,195 shares of common stock as “make-whole” dividend payments on the Series E 9% Convertible Preferred Stock.

 

During the six months ended January 31, 2014, the Company issued 70,732,022 shares of common stock upon the exercise of warrants which had an exercise price of $0.03 per share. The Company received cash proceeds of $2,121,961 upon the exercise of these warrants and an additional value of $2,039,599 was transferred from the value of the derivative warrant liability to additional paid in capital upon such warrant exercises.

 

Stock option expense of $5,365 related to the amortization of executive and employee options granted in October 2009, was charged to the interim consolidated statements of operations during the six months ended January 31, 2014, in addition to stock option expense related to options granted to executives, directors and employees in exchange for repayment of deferred salaries in the amount of $257,505.

 

During the six months ended January 31, 2014, the Company received cash proceeds of $526 from exercises of options at $0.001 per share.  The Company issued 526,306 shares of common stock as a result of these exercises.

 

During the six months ended January 31, 2014, the Company recognized an increase in equity of $237,566 related to the partial exercise of the additional investment rights related to the Company’s June 2013 convertible preferred stock financing.

 

The stockholders’ deficiency transactions for the six months ended January 31, 2014 as described above are summarized below:

 

 

       Additional   Change to 
   Common Stock   Paid-In   Stockholders 
   Shares   Amount   Capital   Equity 
                 
Issuance of common stock on conversion of convertible preferred stock   30,166,666   $30,167   $(30,167)  $ 
Issuance of common stock as make-whole payments on convertible preferred stock   8,730,195    8,730    235,620    244,350 
Issuance of common stock for services   1,233,334    1,233    75,767    77,000 
Issuance of common stock as employee compensation   4,333,333    4,333    125,667    130,000 
Issuance of common stock for cash warrant exercises   70,732,022    70,731    4,090,828    4,161,559 
Issuance of options in lieu of deferred salary           257,505    257,505 
Exercise of employee stock options   526,306    526        526 
Partial exercise of additional investment rights           237,566    237,566 
Amortization of stock options as employee compensation           5,365    5,365 
Total   115,721,856   $115,720   $4,998,151   $ 5,113,871 

 

Warrants

The following is a summary of warrants issued, forfeited or expired and exercised for the six months ended January 31, 2014:

 

   Warrants 
Outstanding, August 1, 2013   238,229,939 
Plus: Issued   26,666,668 
Less: Exercised   70,732,022 
Outstanding, January 31, 2014   194,164,585 

 

The outstanding warrants at January 31, 2014 have a weighted average exercise price of $0.10 per share and have a weighted average remaining life of 3.0 years.

 

As of January 31, 2014, the Company has 69,516,756 warrants with a current exercise price of $0.03 and an expiry date of March 31, 2016, 27,272,720 warrants with a current exercise price of $0.03 and an expiry date of September 30, 2016, 5,675,227 warrants with a current exercise price of $0.03 and an expiry date of February 1, 2017, 4,999,999 warrants with a current exercise price of $0.03 and an expiry date of August 10, 2017, 8,324,144 warrants with a current exercise price of $0.03 and an expiry date of December 12, 2017, 34,166,669 warrants with a current exercise price of $0.03 and an expiry date of June 17, 2018 and 26,666,668 warrants with a current exercise price of $0.03 and an expiry date of January 15, 2019 (176,622,183 warrants in total), which have price protection provisions that allow for the reduction in the current exercise price upon the occurrence of certain events, including the Company’s issuance of common stock or securities convertible into or exercisable for common stock, such as options and warrants, at a price per share less than the exercise price then in effect. For instance, if the Company issues shares of its common stock or options exercisable for or securities convertible into common stock at an effective price per share of common stock less than the exercise price then in effect, the exercise price will be reduced to the effective price of the new issuance. Simultaneously with any reduction to the exercise price, the number of shares of common stock that may be purchased upon exercise of each of these warrants shall be increased proportionately, so that after such adjustment the aggregate exercise price payable for the adjusted number of warrants shall be the same as the aggregate exercise price in effect immediately prior to such adjustment.

 

The Company’s issuance of the following securities will not trigger the price protection provisions of the warrants described above that were issued in connection with the March 2008 private placement: (a) shares of common stock or standard options to the Company’s directors, officers, employees or consultants pursuant to a board-approved equity compensation program or other contract or arrangement (up to an aggregate amount of 5,608,926, representing 5% of the common stock issued and outstanding immediately prior to March 31, 2008); (b) shares of common stock issued upon the conversion or exercise of any security, right or other instrument convertible or exchangeable into common stock (or securities exchangeable into common stock) issued prior to March 31, 2008; (c) the shares of common stock issued upon exercise of the warrants issued in March 2008; and (d) shares of common stock and warrants in connection with strategic alliances, acquisitions, mergers, and strategic partnerships, the primary purpose of which is not to raise capital, and which are approved in good faith by the Company’s board of directors (up to an aggregate number of 11,217,852, representing 10% of the shares of common stock issued and outstanding immediately prior to March 31, 2008).

 

The Company’s issuance of the following securities will not trigger the price protection provisions of the warrants issued on February 2, 2012: (I)(a) shares of common stock or options to employees, officers or directors of the Company pursuant to any stock or option plan duly adopted for such purpose, by a majority of the non-employee members of the Board of Directors or a majority of the members of a committee of non-employee directors established for such purpose, (b) shares of common stock issued to the vendors identified in Securities Purchase Agreement dated January 31, 2012, in the periodic amounts set forth therein, (c) securities upon the exercise or exchange of or conversion of any Securities issued under the Securities Purchase Agreements dated July 8, 2011 and January 31, 2012 and/or other securities exercisable or exchangeable for or convertible into shares of common stock issued and outstanding on February 2, 2012, provided that such securities have not been amended since the date of this Agreement to increase the number of such securities or to decrease the exercise price, exchange price or conversion price of such securities, and (d) securities issued pursuant to acquisitions or strategic transactions approved by a majority of the disinterested directors of the Company, provided that any such issuance shall only be to a person (or to the equityholders of a person) which is, itself or through its subsidiaries, an operating company or an owner of an asset in a business synergistic with the business of the Company and shall provide to the Company additional benefits in addition to the investment of funds, but shall not include a transaction in which the Company is issuing securities primarily for the purpose of raising capital or to an entity whose primary business is investing in securities.

 

The Company’s issuance of the following securities will not trigger the price protection provisions of the warrants issued on August 10, 2012: (I)(a) shares of common stock or options to employees, officers or directors of the Company pursuant to any stock or option plan duly adopted for such purpose, by a majority of the non-employee members of the Board of Directors or a majority of the members of a committee of non-employee directors established for such purpose, (b) shares of common stock issued to the vendors identified in Securities Purchase Agreement dated August 8, 2012, in the periodic amounts set forth therein, (c) securities upon the exercise or exchange of or conversion of any Securities issued under the Securities Purchase Agreements dated July 8, 2011, January 31, 2012 and August 8, 2012 and/or other securities exercisable or exchangeable for or convertible into shares of common stock issued and outstanding on August 8, 2012, provided that such securities have not been amended since the date of this Agreement to increase the number of such securities or to decrease the exercise price, exchange price or conversion price of such securities, and (d) securities issued pursuant to acquisitions or strategic transactions approved by a majority of the disinterested directors of the Company, provided that any such issuance shall only be to a person (or to the equityholders of a person) which is, itself or through its subsidiaries, an operating company or an owner of an asset in a business synergistic with the business of the Company and shall provide to the Company additional benefits in addition to the investment of funds, but shall not include a transaction in which the Company is issuing securities primarily for the purpose of raising capital or to an entity whose primary business is investing in securities.

 

The Company’s issuance of the following securities will not trigger the price protection provisions of the warrants issued on December 10, 2012: (I)(a) shares of common stock or options to employees, officers or directors of the Company pursuant to any stock or option plan duly adopted for such purpose, by a majority of the non-employee members of the Board of Directors or a majority of the members of a committee of non-employee directors established for such purpose, (b) shares of common stock issued to the vendors identified in Securities Purchase Agreement dated December 10, 2012, in the periodic amounts set forth therein, (c) securities upon the exercise or exchange of or conversion of any Securities issued under the Securities Purchase Agreements dated July 8, 2011, January 31, 2012, August 8, 2012 and December 10, 2012 and/or other securities exercisable or exchangeable for or convertible into shares of common stock issued and outstanding on December 10, 2012, provided that such securities have not been amended since the date of this Agreement to increase the number of such securities or to decrease the exercise price, exchange price or conversion price of such securities, and (d) securities issued pursuant to acquisitions or strategic transactions approved by a majority of the disinterested directors of the Company, provided that any such issuance shall only be to a person (or to the equityholders of a person) which is, itself or through its subsidiaries, an operating company or an owner of an asset in a business synergistic with the business of the Company and shall provide to the Company additional benefits in addition to the investment of funds, but shall not include a transaction in which the Company is issuing securities primarily for the purpose of raising capital or to an entity whose primary business is investing in securities.

 

The Company’s issuance of the following securities will not trigger the price protection provisions of the warrants issued on June 17, 2013: (I)(a) shares of common stock or options to employees, officers or directors of the Company pursuant to any stock or option plan duly adopted for such purpose, by a majority of the non-employee members of the Board of Directors or a majority of the members of a committee of non-employee directors established for such purpose, (b) shares of common stock issued to the vendors identified in Securities Purchase Agreement dated June 17, 2013, in the periodic amounts set forth therein, (c) securities upon the exercise or exchange of or conversion of any Securities issued under the Securities Purchase Agreements dated July 8, 2011, January 31, 2012, August 8, 2012, December 10, 2012 and June 17, 2013 and/or other securities exercisable or exchangeable for or convertible into shares of common stock issued and outstanding on June 17, 2013, provided that such securities have not been amended since the date of this Agreement to increase the number of such securities or to decrease the exercise price, exchange price or conversion price of such securities, and (d) securities issued pursuant to acquisitions or strategic transactions approved by a majority of the disinterested directors of the Company, provided that any such issuance shall only be to a person (or to the equityholders of a person) which is, itself or through its subsidiaries, an operating company or an owner of an asset in a business synergistic with the business of the Company and shall provide to the Company additional benefits in addition to the investment of funds, but shall not include a transaction in which the Company is issuing securities primarily for the purpose of raising capital or to an entity whose primary business is investing in securities.

 

The Company’s issuance of the following securities will not trigger the price protection provisions of the warrants issued on January 15, 2014: (I)(a) shares of common stock or options to employees, officers or directors of the Company pursuant to any stock or option plan duly adopted for such purpose, by a majority of the non-employee members of the Board of Directors or a majority of the members of a committee of non-employee directors established for such purpose, (b) shares of common stock issued to the vendors identified in Securities Purchase Agreement dated January 15, 2014, in the periodic amounts set forth therein, (c) securities upon the exercise or exchange of or conversion of any Securities issued under the Securities Purchase Agreements dated January 31, 2012, August 8, 2012, December 10, 2012, June 17, 2013 and January 15, 2014 and/or other securities exercisable or exchangeable for or convertible into shares of common stock issued and outstanding on January 15, 2014, provided that such securities have not been amended since the date of this Agreement to increase the number of such securities or to decrease the exercise price, exchange price or conversion price of such securities, and (d) securities issued pursuant to acquisitions or strategic transactions approved by a majority of the disinterested directors of the Company, provided that any such issuance shall only be to a person (or to the equityholders of a person) which is, itself or through its subsidiaries, an operating company or an owner of an asset in a business synergistic with the business of the Company and shall provide to the Company additional benefits in addition to the investment of funds, but shall not include a transaction in which the Company is issuing securities primarily for the purpose of raising capital or to an entity whose primary business is investing in securities.

 

The Company accounts for the warrants with price protection provisions in accordance with FASB ASC Topic 815 as described in Note 10 - Derivative Liabilities below. As of January 31, 2014, there were a total of 176,622,183 warrants with an estimated fair value of $5,259,929, which are identified on the interim consolidated balance sheets under the caption “Derivative Warrant Liability”.

 

Series A 9% Convertible Preferred Stock

The Company has authorized 5,500 shares of Series A 9% Convertible Preferred Stock with a stated value of one thousand ($1,000) per share. Pursuant to a securities purchase agreement dated July 8, 2011, the Company sold an aggregate of 2,575 shares of convertible preferred stock, as well as accompanying warrants to purchase 17,166,666 shares of common stocks. An aggregate of 17,166,666 shares of the Company’s common stock were issuable upon conversion of the convertible preferred stock which was issued at the initial closing. As of the end of the Company’s fiscal year 2012, all of the issued Series A 9% Convertible Preferred Stock had been converted to common stock. There were 17,166,666 shares of common stock issued upon the conversion of the Series A convertible preferred stock and 6,129,666 shares of common stock issued as “make-whole payments” on such conversions.

 

Series B 9% Convertible Preferred Stock

The Company has authorized 2,000 shares of Series B 9% Convertible Preferred Stock with a stated value of one thousand ($1,000) per share. Pursuant to a securities purchase agreement dated January 31, 2012, the Company sold an aggregate of 2,000 shares of Series B convertible preferred stock, as well as accompanying warrants to purchase 13,333,333 shares of common stocks. An aggregate of 13,333,333 shares of the Company’s common stock were issuable upon conversion of the Series B convertible preferred stock which was issued at the initial closing. On December 10, 2012, the triggering of the price protection features of the Series B convertible preferred stock resulted in a decrease of the conversion price from $0.08 to $0.03 per share and a corresponding increase in the number of common shares underlying the remaining 792 shares of Series B convertible preferred stock as of December 10, 2012 from 9,897,500 to 26,393,333. As of the end of the Company’s fiscal year 2013, all of the issued Series B 9% Convertible Preferred Stock had been converted to common stock. There were 38,520,832 shares of common stock issued upon the conversion of the Series B convertible preferred stock and 14,819,679 shares of common stock issued as “make-whole payments” on such conversions.

 

Series C 9% Convertible Preferred Stock

The Company has authorized 750 shares of Series C 9% Convertible Preferred Stock with a stated value of one thousand ($1,000) per share. Pursuant to a securities purchase agreement dated August 8, 2012, the Company sold an aggregate of 750 shares of Series C convertible preferred stock, as well as accompanying warrants to purchase 9,375,000 shares of common stocks. An aggregate of 9,375,000 shares of the Company’s common stock were issuable upon conversion of the Series C convertible preferred stock which was issued at the initial closing. On December 10, 2012, the triggering of the price protection features of the Series C convertible preferred stock resulted in a decrease of the conversion price from $0.08 to $0.03 per share and a corresponding increase in the number of common shares underlying the 650 shares of Series C convertible preferred stock as of December 10, 2012 from 8,125,000 to 21,666,666. As of the end of the Company’s fiscal year 2013, all of the issued Series C 9% Convertible Preferred Stock had been converted to common stock. There were 22,916,665 shares of common stock issued upon the conversion of the Series C convertible preferred stock and 6,664,863 shares of common stock issued as “make-whole payments” on such conversions.

 

Series D 9% Convertible Preferred Stock

The Company has authorized 750 shares of Series D 9% Convertible Preferred Stock with a stated value of one thousand ($1,000) per share. Pursuant to a securities purchase agreement dated December 10, 2012, the Company sold an aggregate of 750 shares of Series D convertible preferred stock, as well as accompanying warrants to purchase 24,999,999 shares of common stocks. An aggregate of 24,999,999 shares of the Company’s common stock were issuable upon conversion of the Series D convertible preferred stock which was issued at the initial closing. As of the end of the Company’s fiscal year 2013, all of the Series D convertible preferred stock had been converted to common stock. There were 24,999,999 shares of common stock issued upon the conversion of the Series D convertible preferred stock and 7,825,191 shares of common stock issued as “make-whole payments” on such conversions.

 

Series E 9% Convertible Preferred Stock

The Company has authorized 2,450 shares of Series E 9% Convertible Preferred Stock with a stated value of one thousand ($1,000) per share. Pursuant to a securities purchase agreement dated June 17, 2013, the Company sold an aggregate of 1,225 shares of Series E convertible preferred stock, as well as accompanying warrants to purchase 40,833,335 shares of common stocks. An aggregate of 40,833,335 shares of the Company’s common stock are issuable upon conversion of the Series E convertible preferred stock which was issued at the initial closing on June 17, 2013. Pursuant to a securities purchase agreement dated January 14, 2014, the Company sold an aggregate of 800 shares of Series E convertible preferred stock, as well as accompanying warrants to purchase 26,666,668 shares of common stock. An aggregate of 26,666,668 shares of the Company’s common stock are issuable upon conversion of the Series E convertible preferred stock which was issued at the closing on January 15, 2014.

 

Subject to certain ownership limitations, the convertible preferred stock is convertible at the option of the holder at any time into shares of the Company’s common stock at an effective conversion price of $0.03 per share, and will accrue a 9% dividend until June 17, 2016 and, beginning on June 17, 2016 and on each one year anniversary thereafter, such dividend rate will increase by an additional 3%. The dividend is payable quarterly on September 30, December 31, March 31 and June 30, beginning on June 30, 2013 and on each conversion date in cash, or at the Company’s option, in shares of common stock. In the event that the convertible preferred stock is converted prior to June 17, 2016, the Company will pay the holder of the converted preferred stock an amount equal to $270 per $1,000 of stated value of the convertible preferred stock, less the amount of all prior quarterly dividends paid on such converted preferred stock before the relevant conversion date. Such “make-whole payment” may be made in cash or, at the Company’s option, in shares of its common stock. In addition, beginning June 17, 2016, the Company will pay dividends on shares of preferred stock equal to (on an as-if-converted-to-common-stock basis) and in the same form as dividends (other than dividends in the form of common stock) actually paid on shares of the common stock when, and if such dividends are paid. The Company will incur a late fee of 18% per annum on unpaid dividends.

 

The conversion price of the convertible preferred stock is subject to adjustment in the case of stock splits, stock dividends, combinations of shares, similar recapitalization transactions and certain pro-rata distributions to common stockholders. The conversion price will also be adjusted if the Company sells or grants any shares of common stock or securities convertible into, or rights to acquire, common stock at an effective price per share that is lower than the then conversion price, except in the event of certain exempt issuances. In addition, the holders of convertible preferred stock will be entitled to receive any securities or rights to acquire securities or property granted or issued by the Company pro rata to the holders of its common stock to the same extent as if such holders had converted all of their shares of convertible preferred stock. In the event of a fundamental transaction, such as a merger, consolidation, sale of substantially all assets and similar reorganizations or recapitalizations, the holders of convertible preferred stock will be entitled to receive, upon conversion of their shares, any securities or other consideration received by the holders of the Company’s common stock pursuant to the fundamental transaction.

 

The Company may become obligated to redeem the convertible preferred stock in cash upon the occurrence of certain triggering events, including the failure to provide an effective registration statement covering shares of common stock issuable upon conversion of the convertible preferred stock, material breach of certain contractual obligations to the holders of the convertible preferred stock, the occurrence of a change in control of the Company, the occurrence of certain insolvency events relating to the Company, or the failure of the Company’s common stock to continue to be listed or quoted for trading on one or more specified United States securities exchanges or regulated quotation services. Upon the occurrence of certain triggering events, each holder of convertible preferred stock will have the option to redeem such holder’s shares of convertible preferred stock for a redemption price payable in shares of common stock or receive an increased dividend rate of 18% on all of such holder’s outstanding convertible preferred stock.

 

In conjunction with the issuance of the Series E convertible preferred stock in June 2013 and January 2014, the Company also issued 40,833,335 and 26,666,668 warrants, respectively to the investors. Subject to certain ownership limitations, the warrants will be exercisable at any time after their respective dates of issuance and on or before the fifth-year anniversary thereafter at an exercise price of $0.03 per share of common stock. The exercise price of the warrants and, in some cases, the number of shares issuable upon exercise, are subject to adjustment in the case of stock splits, stock dividends, combinations of shares, similar recapitalization transactions and certain pro-rata distributions to common stockholders. The exercise price and number of shares of common stock issuable upon exercise will also be adjusted if the Company sells or grants any shares of common stock or securities convertible into, or rights to acquire, common stock at an effective price per share that is lower than the then exercise price, except in the event of certain exempt issuances. In addition, the warrant holders will be entitled to receive any securities or rights to acquire securities or property granted or issued by the Company pro rata to the holders of its common stock to the same extent as if such holders had exercised all of their warrants. In the event of a fundamental transaction, such as a merger, consolidation, sale of substantially all assets and similar reorganizations or recapitalizations, the warrant holders will be entitled to receive, upon exercise of their warrants, any securities or other consideration received by the holders of the Company’s common stock pursuant to the fundamental transaction. These warrants have been classified as derivative liabilities and are described further in Note 10 – Derivative Liabilities.

 

In addition, until the first anniversary date of the initial securities purchase agreement, each investor may, in its sole determination, elect to purchase, severally and not jointly with the other investors, in one or more purchases, in the ratio of such investor's original subscription amount to the original aggregate subscription amount of all investors, additional units consisting of convertible preferred stock and warrants at a purchase price of $1,000 per unit with an aggregate subscription amount thereof of up to $1,225,000, which units will have terms identical to the units of convertible preferred stock and warrants issued in connection with the June 2013 closing. These additional investment rights of the investors have been classified as derivative liabilities and are described further in Note 10 – Derivative Liabilities. On January 15, 2014, certain investors exercised 800 of the 1,225 shares of convertible preferred stock and related warrants available under the additional investment rights. Certain investors will continue to have rights to purchase up to 425 shares of convertible preferred stock and related warrants until June 17, 2014.

 

As of January 31, 2014, 1,200 of the Series E convertible preferred stock had been converted to common stock. There were 40,000,000 shares of common stock issued upon the conversion of the Series E convertible preferred stock and 11,385,194 shares of common stock issued as “make-whole payments” on such conversions.

 

Accounting for proceeds from the Series E convertible preferred stock financing

 

The net cash proceeds from the initial Series E convertible preferred stock financing in June 2013 were $1,165,000. The proceeds from the financing were allocated first to the warrants that were issued in the financing, second to the additional investment rights associated with the financing and third to the make whole payments. As the assigned fair values were greater than the net cash proceeds from the transaction, the excess was treated as a “deemed dividend” for accounting purposes and was reported on the Company’s consolidated statement of operations for the year ended July 31, 2013 under the caption “Preferred Stock Dividend”. The calculation methodologies for the fair values of the derivative warrant liability and the derivative additional investment rights liability are described in Note 10 – Derivative Liabilities below. The fair values assigned to each component and the calculation of the amount of the deemed dividend are as follows:

 

     Accounting allocation of initial proceeds    
  Net proceeds          $   1,165,000
  Derivative warrant liability fair value         (1,189,744)
  Derivative additional investment rights fair value    (1,264,683)
  Make whole payments liability  (330,750)
  Deemed dividend   $ (1,620,177)

 

The initial “make-whole payments” of $330,750 on the Series E convertible preferred stock were accrued as of the date of the financing and the remaining balance of $6,750 (after conversions) is included in Accounts Payable and Accrued Expenses (see Note 5) at January 31, 2014.

 

The net cash proceeds from the Series E convertible preferred stock financing in January 2014 were $750,000. The proceeds from the financing were allocated first to the warrants that were issued in the financing and second to the make whole payments. As the assigned fair values were greater than the net cash proceeds from the transaction, the excess was treated as a “deemed dividend” for accounting purposes and was reported on the Company’s consolidated statement of operations for the quarter ended January 31, 2014 under the caption “Preferred Stock Dividend”. The calculation methodologies for the fair values of the derivative warrant liability and the derivative additional investment rights liability are described in Note 10 – Derivative Liabilities below. The fair values assigned to each component and the calculation of the amount of the deemed dividend are as follows:

 

     Accounting allocation of initial proceeds    
  Net proceeds          $ 750,000
  Derivative warrant liability fair value         (942,279)
  Make whole payments liability  (216,000)
  Deemed dividend   $(408,279)

 

The initial “make-whole payments” of $216,000 on the Series E convertible preferred stock were accrued as of the date of the financing and that balance is included in Accounts Payable and Accrued Expenses (see Note 5) at January 31, 2014.

XML 45 R13.htm IDEA: XBRL DOCUMENT v2.4.0.8
Commitments
3 Months Ended
Jan. 31, 2014
Commitments and Contingencies Disclosure [Abstract]  
Commitments

Note 7 – Commitments:

 

On December 7, 2009, the Company entered into a long-term agreement with sanofi-aventis Deutschland GmbH (“sanofi”). Under this agreement, sanofi will manufacture and supply recombinant human insulin to the Company in the territories specified in the agreement. Through this agreement, the Company will procure recombinant human insulin crystals for use in the production of Generex Oral-lyn™. The terms of the supply agreement required the Company to make certain minimum purchases of insulin from sanofi through the period ended December 31, 2011. To date, the Company has not met the minimum purchase commitments under this agreement. After December 31, 2011, sanofi may terminate the agreement due to the Company’s failure to meet such purchase commitments. Upon termination, the Company would be obligated to pay sanofi for all materials and components that it has acquired or ordered to manufacture insulin based on the Company’s forecasts or minimum purchase commitments, all related work-in-progress (at cost) and all finished insulin in inventory. To date, the Company has not provided forecasts to sanofi for the purchase of insulin and sanofi has not terminated the agreement.

XML 46 R14.htm IDEA: XBRL DOCUMENT v2.4.0.8
Net Income/Loss Per Share (“EPS”)
3 Months Ended
Jan. 31, 2014
Accounting Policies [Abstract]  
Net Loss Per Share (“EPS”)

Note 8 – Net Loss Per Share (“EPS”):

 

Basic EPS and Diluted EPS for the three and six-month periods ended January 31, 2014 have been computed by dividing the net loss available to common stockholders for the period by the weighted average shares outstanding during each period. All outstanding stock options, non-vested restricted stock, warrants and common stock underlying convertible preferred stock, representing 259,678,976 incremental shares at January 31, 2014, have been excluded from the respective computations of Diluted EPS as they are anti-dilutive, due to the loss generated during that period.

 

Basic EPS and Diluted EPS for the three and six-month periods ended January 31, 2013 have been computed by dividing the net loss available to common stockholders for the period by the weighted average shares outstanding during each period. All outstanding stock options, non-vested restricted stock, warrants and common stock underlying convertible preferred stock, representing 270,883,228 incremental shares at January 31, 2013, have been excluded from the respective computations of Diluted EPS as they are anti-dilutive, due to the loss generated during that period.

XML 47 R16.htm IDEA: XBRL DOCUMENT v2.4.0.8
Derivative Liabilities
3 Months Ended
Jan. 31, 2014
Notes to Financial Statements  
Derivative Liabilities

Note 10 – Derivative Liabilities:

 

Derivative warrant liability

The Company has warrants outstanding with price protection provisions that allow for the reduction in the exercise price of the warrants in the event the Company subsequently issues stock or securities convertible into stock at a price lower than the exercise price of the warrants. Simultaneously with any reduction to the exercise price, the number of shares of common stock that may be purchased upon exercise of each of these warrants shall be increased or decreased proportionately, so that after such adjustment the aggregate exercise price payable for the adjusted number of warrants shall be the same as the aggregate exercise price in effect immediately prior to such adjustment.

 

Accounting for Derivative Warrant Liability

The Company’s derivative instruments have been measured at fair value at January 31, 2014 and July 31, 2013 using the binomial lattice model. The Company recognizes all of its warrants with price protection in its consolidated balance sheets as a liability. The liability is revalued at each reporting period and changes in fair value are recognized currently in the consolidated statements of operations. The initial recognition and subsequent changes in fair value of the derivative warrant liability have no effect on the Company’s consolidated cash flows.

 

The derivative warrants outstanding at January 31, 2014 are all currently exercisable with a weighted-average remaining life of 3.2 years.

 

The revaluation of the warrants at ends of the respective reporting periods resulted in the recognition of a loss of $230,557 within the Company’s consolidated statements of operations for the six months ended January 31, 2014 and a loss of $3,783,290 for the six months ended January 31, 2013, which is included in the consolidated statement of operations under the caption “Change in fair value of derivative liabilities”. The fair value of the warrants at January 31, 2014 and July 31, 2013 was $5,259,929 and $5,234,293, respectively, which is reported on the consolidated balance sheets under the caption “Derivative Warrant Liability”. The following summarizes the changes in the value of the derivative warrant liability from August 1, 2012 until January 31, 2014:

              Value No. of Warrants
Balance at August 1, 2012 – Derivative warrant liability $   4,081,627 55,148,530
Additional warrants issued in August 2012 financing   624,797   9,375,000
Additional warrants issued in December 2012 financing   762,355 24,999,999
Additional warrants issued in June 2013 financing   1,189,744  40,833,335
Additional warrants from price protection features of existing warrants   7,484,550   236,219,094
Exercise of warrants (5,629,130) (145,888,421)
Decrease in fair value of derivative warrant liability (3,279,650)                   n/a
Balance at July 31, 2013 – Derivative warrant liability  $   5,234,293   220,687,537
Exercise of warrants (2,039,599) (70,732,022)
Additional warrants issued in January 2014 financing   942,279 26,666,668
Increase in fair value of derivative warrant liability    1,122,959                  n/a
Balance at January 31, 2014 – Derivative warrant liability  $  5,259,929   176,622,183

 

Fair Value Assumptions Used in Accounting for Derivative Warrant Liability

The Company has determined its derivative warrant liability to be a Level 2 fair value measurement and has used the binominal lattice pricing model to calculate the fair value as of January 31, 2014 and July 31, 2013. The binomial lattice model requires six basic data inputs: the exercise or strike price, time to expiration, the risk free interest rate, the current stock price, the estimated volatility of the stock price in the future, and the dividend rate. Because the warrants contain the price protection feature, the probability that the exercise price of the warrants would decrease as the stock price decreased was incorporated into the valuation calculations. The key inputs used in the January 31, 2014 and July 31, 2013 fair value calculations were as follows:

 

   January 31, 2014   July 31, 2013 
Current exercise price  $0.03   $0.03 
Time to expiration   3.2 years    3.5 years 
Risk-free interest rate   0.69%   0.49%
Estimated volatility   86%   85%
Dividend   -0-    -0- 
Stock price at period end date  $0.03   $0.035 

 

Fair Value Assumptions Used in Accounting for Derivative Additional Investment Rights Liability

The Company has determined the derivative additional investment rights liability to be a Level 2 fair value measurement and has used the binominal lattice pricing model to measure the fair value. The fair value of the derivative liability associated with the additional investment rights was determined to be $126,195 and $1,256,160 at January 31, 2014 and July 31, 2013, respectively.

 

 

The key inputs used in the fair value calculation at January 31, 2014 and July 31, 2013 were as follows:

 

   January 31, 2014   July 31, 2013 
Underlying number of units of convertible preferred stock   425    1,225 
Underlying number of units of warrants   14,166,667    40,833,335 
Current exercise price of warrants  $0.03   $0.03 
Current conversion price of preferred stock  $0.03   $0.03 
Time to expiration   0.38 years    0.88 years 
Risk-free interest rate   0.06%   0.11%
Estimated volatility   67%   114%
Dividend   -0-    -0- 
Stock price at period end date  $0.042   $0.035 

 

The partial exercise of the additional investment rights in the quarter ended January 31, 2014, resulted in a transfer from the derivative liability to additional paid in capital of $237,566, which was the estimated fair value of the additional investment rights exercised as of the date of exercise on January 15, 2014. The revaluation of the additional investment rights in the six-month period ended January 31, 2014, resulted in the recognition of a gain of $892,399 within the Company’s consolidated statements of operations, which is included in the total under the caption “Change in fair value of derivative liabilities”.

XML 48 R34.htm IDEA: XBRL DOCUMENT v2.4.0.8
Stockholders' (Deficiency)/Equity (Details Narrative) (USD $)
6 Months Ended 216 Months Ended 6 Months Ended
Jan. 31, 2014
Jan. 31, 2013
Jan. 31, 2014
Jul. 31, 2013
Jan. 31, 2014
Various Consultants
Jan. 31, 2014
Employee Compensation
Jan. 31, 2014
Series E Convertible Preferred Stock
Jan. 15, 2014
Series E Convertible Preferred Stock
Jan. 31, 2014
Make-Whole Dividend Payments
Jan. 31, 2014
Upon Exercise Of Warrants
Jan. 31, 2014
Upon Exercise Of Options
Jan. 31, 2014
Executives, Directors, Employees
Jan. 31, 2014
Warrant Expiration Date 31 March 2016
Jan. 31, 2014
Warrant Expiration Date 11 July 2016
Jan. 31, 2014
Warrant Expiration Date 30 September 2016
Jan. 31, 2014
Warrant Expiration Date 1 February 2017
Jan. 31, 2014
Warrant Expiration Date 10 August 2017
Jan. 31, 2014
Warrant Expiration Date 12 December 2017
Jan. 31, 2014
Warrant Expiration Date 17 June 2018
Jan. 31, 2014
Total Warrants
Jan. 31, 2014
Board Approved Equity Program
Jan. 31, 2014
Approved In Good Faith
Common stock issued, or committed to issue, Shares         1,233,334 4,333,333 30,166,666   5,201,739 70,732,022 526,306                   5,608,926 11,217,852
Common stock issued, or committed to issue, Amount $ 696,050   $ 696,050 $ 580,329 $ 77,000 $ 130,000   $ 26,666,668   $ 2,121,961                        
Common stock, value per share $ 0.001   $ 0.001 $ 0.001 $ 0.03 $ 0.03       $ 0.03 $ 0.001                      
Common stock, value per share (Maximum)         $ 0.15                                  
Conversion of shares of Series E, Convertible Preferred Stock             905                              
Additional value or warrant exercised                   2,039,599                        
Charge to operations, stock option expense       4,011,938                 5,365                    
Repayment of deferred salaries 257,505   257,505                                      
Cash proceeds                     526                      
Outstanding warrants, weighted average exercise price $ 0.09                                          
Outstanding warrants, weighted average remaining life (in years) 3 years 15 days                                          
Number of shares to be purchased 194,164,585   194,164,585 238,229,939                 69,516,756 1,175,227 27,272,720 5,675,227 4,999,999 8,324,144 34,166,669 26,666,668    
Number of shares to be purchased, exercise price $ 0.03   $ 0.03 $ 0.03                 $ 0.03 $ 0.03 $ 0.03 $ 0.03 $ 0.03 $ 0.03 $ 0.03 $ 0.03    
Percentage of common stock issued and outstanding                                         5.00% 10.00%
Estimated value of warrants 26,666,668                                          
Increase in equity $ 237,566   $ 237,566                                      
XML 49 R21.htm IDEA: XBRL DOCUMENT v2.4.0.8
Stockholders’ Deficiency (Tables)
1 Months Ended 3 Months Ended
Jun. 30, 2013
Jan. 31, 2014
Equity [Abstract]    
Stockholders’ deficiency transactions  

 

       Additional   Change to 
   Common Stock   Paid-In   Stockholders 
   Shares   Amount   Capital   Equity 
                 
Issuance of common stock on conversion of convertible preferred stock   30,166,666   $30,167   $(30,167)  $ 
Issuance of common stock as make-whole payments on convertible preferred stock   8,730,195    8,730    235,620    244,350 
Issuance of common stock for services   1,233,334    1,233    75,767    77,000 
Issuance of common stock as employee compensation   4,333,333    4,333    125,667    130,000 
Issuance of common stock for cash warrant exercises   70,732,022    70,731    4,090,828    4,161,559 
Issuance of options in lieu of deferred salary           257,505    257,505 
Exercise of employee stock options   526,306    526        526 
Partial exercise of additional investment rights           237,566    237,566 
Amortization of stock options as employee compensation           5,365    5,365 
Total   115,721,856   $115,720   $4,998,151   $ 5,113,871 

 

Summary of warrants issued, forfeited or expired and exercised  
   Warrants 
Outstanding, August 1, 2013   238,229,939 
Plus: Issued   26,666,668 
Less: Exercised   70,732,022 
Outstanding, January 31, 2014   194,164,585 
Accounting allocation of initial proceeds
     Accounting allocation of initial proceeds    
  Net proceeds          $   1,165,000
  Derivative warrant liability fair value         (1,189,744)
  Derivative additional investment rights fair value    (1,264,683)
  Make whole payments liability  (330,750)
  Deemed dividend   $ (1,620,177)
     Accounting allocation of initial proceeds    
  Net proceeds          $ 750,000
  Derivative warrant liability fair value         (942,279)
  Make whole payments liability  (216,000)
  Deemed dividend   $(408,279)
XML 50 R26.htm IDEA: XBRL DOCUMENT v2.4.0.8
Stock-Based Compensation (Details Narrative)
6 Months Ended
Jan. 31, 2014
Options
 
Common stock reserved for future awards 38,014,390
Outstanding options 38,014,390
Outstanding options, weighted average remaining contractual term 4 years 2 months 12 days
Stock Option Plan 2001
 
Common stock reserved for future issuance 12,000,000
Common stock reserved for future awards 1,353,916
Stock Option Plan 2006
 
Common stock reserved for future issuance 60,000,000
Common stock reserved for future awards 6,417,242
XML 51 R5.htm IDEA: XBRL DOCUMENT v2.4.0.8
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) (USD $)
6 Months Ended 216 Months Ended
Jan. 31, 2014
Jan. 31, 2013
Jan. 31, 2014
Cash Flows From Operating Activities:      
Net income/(loss) $ (2,656,196) $ (6,297,184) $ (365,384,078)
Adjustments to reconcile net loss to net cash used in operating activities:      
Depreciation and amortization 191,795 234,603 10,564,053
Minority interest share of loss       (3,038,185)
Reduction of notes receivable - common stock in exchange for services rendered       423,882
Write-off of uncollectible notes receivable - common stock       391,103
Write-off of deferred offering costs       3,406,196
Write-off of abandoned patents       1,353,976
Gain on disposal of property and equipment (188,869) (993,867) (3,217,504)
Loss on extinguishment of debt       14,134,068
Common stock issued as employee compensation       4,011,938
Amortization of options and option modifications as stock compensation 262,871 19,697 4,511,851
Common stock issued for services rendered 207,000 185,342 15,106,700
Amortization of prepaid services in conjunction with common stock issuance       138,375
Non-cash compensation expense       45,390
Stock options and warrants issued for services rendered       7,956,723
Issuance of warrants as additional exercise right inducement       21,437,909
Preferred stock issued for services rendered       100
Treasury stock redeemed for non-performance of services       (138,000)
Amortization of deferred debt issuance costs and loan origination fees       2,405,629
Amortization of discount on convertible debentures       38,345,592
Common stock issued for interest on convertible debentures & preferred stock 244,350 604,800 2,374,004
Interest on short-term advance       22,190
Founders' shares transferred for services rendered       353,506
Fees in connection with refinancing of debt       113,274
Warrant repricing costs       3,198,604
Change in fair value of derivative liabilities 230,557 3,783,290 4,086,793 [1]
Changes in operating assets and liabilities (excluding the effects of acquisition):      
Accounts receivable       (15,047)
Miscellaneous receivables       43,812
Inventory       (20,091)
Other current assets (5,617) 39,179 (64,368)
Accounts payable and accrued expenses 51,665 449,789 15,199,161
Deferred revenue (1,181) (25,300) 217,869
Other, net       110,317
Net Cash Used in Operating Activities (1,663,625) (1,999,651) (221,924,257)
Cash Flows From Investing Activities:      
Purchase of property and equipment       (4,809,439)
Proceeds from sale of property and equipment 883,780 1,578,779 7,601,113
Costs incurred for patents (34,674) (40,234) (2,953,668)
Change in restricted cash       512,539
Proceeds from maturity of short term investments       195,242,918
Purchases of short-term investments       (195,242,918)
Cash received in conjunction with merger       82,232
Advances to Antigen Express, Inc.       (32,000)
Increase in officers' loans receivable       (1,126,157)
Change in deposits       (652,071)
Change in notes receivable - common stock       (91,103)
Change in due from related parties       (2,222,390)
Other, net       89,683
Net Cash Provided By (Used in) Investing Activities 849,106 1,538,545 (3,601,261)
Cash Flows From Financing Activities:      
Proceeds from short-term advance       325,179
Repayment of short-term advance       (347,369)
Proceeds from issuance of long-term debt    866,403 6,396,335
Repayment of long-term debt (606,806) (1,692,957) (9,502,770)
Repayment of obligations under capital lease       (83,002)
Change in due to related parties       154,541
Proceeds from exercise of warrants, net 2,121,961 724,664 49,695,446
Proceeds from exercise of stock options 526 86 5,009,500
Proceeds from minority interest investment       3,038,185
Proceeds from issuance of preferred stock, net 750,000 1,450,000 19,670,000
Redemption of SVR preferred stock       (100)
Proceeds from issuance of convertible debentures, net       40,704,930
Payment of costs associated with convertible debentures       (722,750)
Repayments of convertible debentures       (5,142,424)
Purchase of treasury stock       (483,869)
Proceeds from issuance of common stock, net       120,576,242
Purchase and retirement of common stock       (497,522)
Net Cash Provided by Financing Activities 2,265,681 1,348,196 228,790,552
Effect of Exchange Rates on Cash (18,904) (10,687) (123,822)
Net Increase in Cash and Cash Equivalents 1,432,258 876,403 3,141,212
Cash and Cash Equivalents, Beginning of Period 1,708,954 246,309  
Cash and Cash Equivalents, End of Period 3,141,212 1,122,712 3,141,212
Supplemental Disclosure of Cash Flow Information      
Cash paid during the period for Interest 35,541 143,333  
Cash paid during the period for Income taxes        
[1] Includes $5,981,403 as adjustment related to the adoption of FASB ASC Topic 815 in "Cumulative from November 2, 1995 (Date of Inception) to January 31, 2014" column. See Note 10 - Derivative Warrant Liability.
XML 52 R10.htm IDEA: XBRL DOCUMENT v2.4.0.8
Comprehensive Income and Loss
3 Months Ended
Jan. 31, 2014
Equity [Abstract]  
Comprehensive Income and Loss

Note 4 – Comprehensive Income and Loss:

 

Comprehensive loss, which includes net loss and the change in the foreign currency translation account, for the six months ended January 31, 2014, was $2,641,950. Comprehensive loss, which includes net loss and the change in the foreign currency translation account, for the six months ended January 31, 2013, was $6,309,575.

 

Comprehensive loss, which includes net loss and the change in the foreign currency translation account, for the three months ended January 31, 2014, was $3,173,721. Comprehensive loss, which includes net loss and the change in the foreign currency translation account, for the three months ended January 31, 2013, was $5,640,896.

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Comprehensive Income and Loss (Details Narrative) (USD $)
3 Months Ended 6 Months Ended
Jan. 31, 2014
Jan. 31, 2013
Jan. 31, 2014
Jan. 31, 2013
Equity [Abstract]        
Comprehensive income/loss $ 3,173,721 $ 5,640,896 $ 2,641,950 $ 6,309,575
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Derivative Liabilities - Fair value assumptions, derivative additional investment rights liability (Details) (USD $)
6 Months Ended 12 Months Ended
Jan. 31, 2014
Jul. 31, 2013
Current exercise price of warrants $ 0.03 $ 0.03
Time to expiration 3 years 2 months 12 days 3 years 6 months
Risk-free interest rate 0.69% 0.49%
Estimated volatility 86.00% 85.00%
Dividend   0.00%
Stock price at period end date $ 0.042 $ 0.035
Additional Investment Rights
   
Underlying number of units of convertible preferred stock 425 1,225
Underlying number of units of warrants 14,166,667 40,833,335
Current exercise price of warrants $ 0.03 $ 0.03
Current conversion price of preferred stock $ 0.03 $ 0.03
Time to expiration 4 months 17 days 10 months 16 days
Risk-free interest rate 0.06% 0.11%
Estimated volatility 67.00% 114.00%
Dividend 0.00% 0.00%
Stock price at period end date $ 0.042 $ 0.035
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Accounts Payable and Accrued Expenses (Tables)
3 Months Ended
Jan. 31, 2014
Payables and Accruals [Abstract]  
Accounts payable and accrued expenses
   January 31, 2014   July 31, 2013 
Accounts Payable and Accruals – General and Administrative  $3,282,163   $3,447,618 
Accounts Payable and Accruals – Research and Development   3,889,180    3,557,184 
Accounts Payable and Accruals – Selling and Marketing   326,929    328,629 
Accrued Make-whole Payments on Convertible Preferred Stock (see Note 9)  222,750    251,100 
Executive Compensation and Directors’ Fees Payable   170,657    76,703 
Total  $7,891,679   $7,661,234